e10vk
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-K
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31,
2010
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OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the transition period
from to
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Commission file number 0-17758
EMISPHERE TECHNOLOGIES,
INC.
(Exact name of registrant as
specified in its charter)
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Delaware
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13-3306985
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(State or other jurisdiction
of
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(I.R.S. Employer
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incorporation or
organization)
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Identification Number)
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240 Cedar Knolls Road, Suite 200
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07927
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Cedar Knolls, NJ
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(Zip Code)
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(Address of principal executive
offices)
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(973)
532-8000
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock $.01 par value
Preferred Stock Purchase Rights
Indicate by check mark if the Registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes o No þ
Indicate by check mark if the Registrant is not required to file
reports pursuant to Section 13 or 15(d) of the
Act. Yes o No þ
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that Registrant was
required to file such reports) and (2) has been subject to
such filing requirements for at least the past
90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of
Regulation S-T
during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such
files). Yes o No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K
(§ 229.405 of this chapter) is not contained herein,
and will not be contained, to the best of registrants
knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this
Form 10-K
or any amendment to this
Form 10-K. o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in
Rule 12b-2
of the Exchange Act. (Check one):
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Large
accelerated
filer o
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Accelerated
filer þ
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Non-accelerated
filer o
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Smaller
reporting
company o
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(Do not check if a smaller reporting company)
Indicate by check mark whether the Registrant is a shell company
(as defined in
Rule 12b-2
of the
Act). Yes o No þ
As of June 30, 2010 (the last business day of the
registrants most recently completed second quarter), the
aggregate market value of the common stock held by
non-affiliates of the Registrant (i.e. excluding shares held by
executive officers, directors, and control persons) was
104,249,326 computed at the closing price on that date.
The number of shares of the Registrants common stock,
$.01 par value, outstanding as of March 25, 2011 was
52,076,602.
PART I
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements made under the captions Business
(Item 1) and Managements Discussion and
Analysis of Financial Condition and Results of Operations
(Item 7), the notes to our audited financial statements
(Item 8) and elsewhere in this Annual Report on
Form 10-K,
as well as statements made from time to time by our
representatives may constitute forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, without limitation, statements regarding planned or
expected studies and trials of oral formulations that utilize
our
Eligen®
Technology; the timing of the development and commercialization
of our product candidates or potential products that may be
developed using our
Eligen®
Technology; the potential market size, advantages or therapeutic
uses of our potential products; variation in actual savings and
operating improvements resulting from restructurings; and the
sufficiency of our available capital resources to meet our
funding needs. We do not undertake any obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by
law. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors which may cause our
actual results or achievements to be materially different from
any future results or achievements expressed or implied by such
forward-looking statements. Such factors include the factors
described in Part 1, Item 1A. Risk Factors
and the other factors discussed in connection with any
forward-looking statements.
Overview
of Emisphere
Introduction
and History
Emisphere Technologies, Inc. (Emisphere, the
Company, our, us, or
we) is a biopharmaceutical company that focuses on a
unique and improved delivery of therapeutic molecules or
nutritional supplements using its
Eligen®
Technology. These molecules could be currently available or are
under development. Such molecules are usually delivered by
injection; in many cases, their benefits are limited due to poor
bioavailability, slow on-set of action or variable absorption.
In those cases, our technology may increase the benefit of the
therapy by improving bioavailability or absorption or by
decreasing time to onset of action. The
Eligen®
Technology can be applied to the oral route of administration as
well other delivery pathways, such as buccal, rectal,
inhalation, intra-vaginal or transdermal. The
Eligen®
Technology can make it possible to deliver certain therapeutic
molecules orally without altering their chemical form or
biological activity.
Eligen®
delivery agents, or carriers, facilitate or enable
the transport of therapeutic molecules across the mucous
membranes of the gastrointestinal tract, to reach the tissues of
the body where they can exert their intended pharmacological
effect. Our core business strategy is to develop oral forms of
drugs or nutrients that are not currently available or have poor
bioavailability in oral form, by applying the
Eligen®
Technology to those drugs or nutrients. Our development efforts
are conducted internally or in collaboration with corporate
development partners. Typically, the drugs that we target are at
an advanced stage of development, or have already received
regulatory approval, and are currently available on the market.
Our website is www.emisphere.com. The contents of that website
are not incorporated herein by reference hereto. Investor
related questions should be directed to info@emisphere.com.
Emisphere was originally founded as Clinical Technologies
Associates, Inc. in 1986. We conducted an initial public
offering in 1989 and were listed on NASDAQ under the ticker
symbol CTAI. In 1990, we decided to focus on our
oral drug delivery technology, now known as the
Eligen®
Technology. In 1991, we changed our name to Emisphere
Technologies, Inc., and we continued to be listed on NASDAQ
under the new ticker symbol EMIS. The Companys
securities were suspended from trading on the NASDAQ Capital
Market effective at the open of business on Tuesday,
June 9, 2009, and NASDAQ delisted the Companys
securities thereafter. The delisting resulted from the
Companys non-compliance with the minimum market value of
listed securities requirement for continued listing.
Simultaneously, the Companys securities began trading on
the
Over-the-Counter
Bulletin Board (the OTCBB), an electronic
quotation service maintained by the Financial Industry
Regulatory Authority, effective with the open of business on
Tuesday, June 9, 2009. The
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Companys trading symbol remains EMIS, however, it is our
understanding that, for certain stock quote publication
websites, investors may be required to key EMIS.OB to obtain
quotes.
Since our inception in 1986, substantial efforts and resources
have been devoted to understanding the
Eligen®
Technology and establishing a product development pipeline that
incorporated this technology with selected molecules. Since
2007, Emisphere has undergone many positive changes. A new
senior management team was hired, the
Eligen®
Technology was reevaluated and our corporate strategy was
refocused on commercializing it as quickly as possible, building
high-value partnerships and reprioritizing the product pipeline.
Spending was redirected and aggressive cost control initiatives
were implemented. These changes resulted in redeployment of
resources to programs, one of which yielded the introduction of
our first commercial product during 2009. We continue to develop
potential product candidates in-house and we demonstrated and
enhanced the value of the
Eligen®
Technology through the progress made by our development partners
Novartis Pharma AG (Novartis) and Novo Nordisk A/S
(Novo Nordisk) on their respective product
development programs. Further development, exploration and
commercialization of the technology entail risk and operational
expenses. However, we have made significant progress on
refocusing our efforts on strategic development initiatives and
cost control and continue to aggressively seek to reduce
non-strategic spending.
The
Eligen®
Technology
The
Eligen®
Technology is a broadly applicable proprietary oral drug
delivery technology based on the use of proprietary synthetic
chemical compounds known as
EMISPHERE®
delivery agents, or carriers. These delivery agents facilitate
and enable the transport of therapeutic macromolecules (such as
proteins, peptides, and polysaccharides) and poorly absorbed
small molecules across biological membranes. The
Eligen®
Technology not only facilitates absorption. but it acts rapidly
in the upper sections of the GI where absorption is thought to
occur. With the
Eligen®
Technology, most of the molecules reach the general circulation
in less than an hour post-dose. Rapid absorption can limit
enzymatic degradation that typically affects macromolecules or
simply be advantageous in cases where time to onset of action is
important (i.e. analgesics). Another characteristic that
distinguishes
Eligen®
from the competition is absorption takes place through a
transcellular, not paracellular, pathway. This underscores the
safety of
Eligen®
as the passage of the
Eligen®
carrier and the molecule preserve the integrity of the tight
junctions within the cell and reduces any likelihood of
inflammatory processes and autoimmune gastrointestinal diseases.
Furthermore,
Eligen®
Technology carriers are rapidly absorbed, distributed,
metabolized and eliminated from the body, they do not accumulate
in the organs and tissues and they are considered safe at
anticipated doses and dosing regimens.
The
Eligen®
Technology was extensively reevaluated in 2007 by our
scientists, senior management and expert consultants. Based on
this analysis, we believe that our technology can enhance
overall healthcare, including patient accessibility and
compliance, while benefiting the commercial pharmaceutical
marketplace and driving company valuation. The application of
the
Eligen®
Technology is potentially broad and may provide for a number of
opportunities across a spectrum of therapeutic modalities.
Implementing the
Eligen®
Technology is quite simple. It only requires co-mixing a drug or
nutritional supplement and an
Eligen®
carrier to produce an effective formulation. The carrier does
not alter the chemical properties of the drug nor its biological
activity. Some therapeutic molecules are better suited for use
with the
Eligen®
Technology than others. Drugs or nutritional supplements whose
bioavailability is limited by poor membrane permeability or
chemical or biological degradation, and which have a
moderate-to-wide
therapeutic index, appear to be the best candidates. Drugs with
a narrow therapeutic window or high molecular weight may not be
favorable with the technology.
We believe that our
Eligen®
Technology makes it possible to safely deliver a therapeutic
macromolecule orally or increase the absorption of a poorly
absorbed small molecule without altering its chemical
composition or compromising the integrity of biological
membranes. We believe that the key benefit of our
Eligen®
Technology is that it improves the ability of the body to absorb
small and large molecules.
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Emisphere
Today
During 2010, the Company continued to focus on efforts to apply
the
Eligen®
Technology and realize its value by developing profitable
commercial applications. The application of the
Eligen®
Technology is potentially broad and may provide for a number of
opportunities across a spectrum of therapeutic modalities or
nutritional supplements. During 2010, we continued to develop
our product pipeline utilizing the
Eligen®
Technology with prescription and nonprescription product
candidates. We prioritized our development efforts based on
overall potential returns on investment, likelihood of success,
and market and medical needs. Our goal is to implement our
Eligen®
Technology to enhance overall healthcare, including patient
accessibility and compliance, while benefiting the commercial
pharmaceutical/healthcare marketplace and driving company
valuation. Investments required to continue developing our
product pipeline may be partially paid by income-generating
license arrangements whose value tends to increase as product
candidates move from pre-clinical into clinical development. It
is our intention that additional investments that may be
required to fund our research and development will be approached
incrementally in order to minimize disruption or dilution.
To accelerate commercialization of the
Eligen®
Technology, Emisphere embarked on a two-pronged strategy. First,
we concentrated on prescription molecules and nutritional
supplements obtained through partnerships with other
pharmaceutical companies for molecules where oral absorption is
difficult yet substantially beneficial if proven. With
prescription molecules, we are working to generate new interest
in the
Eligen®
Technology with potential partners and attempting to expand our
current collaborative relationships to take advantage of the
critical knowledge that others have gained by working with our
technology. Second, we continue to pursue commercialization of
product candidates developed internally. We believe that these
internal candidates need to be developed with reasonable
investment in an acceptable time period and with a reasonable
risk-benefit profile.
To support our internal development programs, the Company
implemented its new commercialization strategy for the
Eligen®
Technology. Using extensive safety data available for its Sodium
N-[8-(2-hydroxybenzoyl) Amino] Caprylate (SNAC)
carrier, the Company obtained GRAS (Generally Recognized
as Safe) status for its SNAC carrier, and then applied the
Eligen®
Technology with B12, another GRAS substance where
bioavailability and absorption is difficult and improving such
absorption would yield substantial benefit and value. Given
sufficient time and resources, the Company intends to apply this
strategy to develop other products. Examples of other GRAS
substances that may be developed into additional commercial
products using this strategy would include vitamins such as
Vitamin D, minerals such as iron, and other supplements such as
the polyphenols and catechins, among others. A higher dose (1000
mcg) formulation of
Eligen®
B12, for use by patients who are Vitamin B12 deficient, is under
development.
Funding required to continue developing our product pipeline may
be partially paid by income-generating license arrangements
whose value tends to increase as product candidates move from
pre-clinical into clinical development. It is our intention that
investments that may be required to fund our research and
development will be approached incrementally in order to
minimize disruption or dilution.
The Company also continues to focus on improving operational
efficiency. By terminating the lease of our research and
development facility in Tarrytown, NY in April 2009 and by
utilizing independent contractors to conduct research and
development, we reduced our annual operating costs by
approximately 45% from 2008 levels and an additional 21% from
2009 levels. Annual cash expenditures in 2009 and 2010 were
reduced by approximately $11 million and $1.1 million,
respectively, and the resulting cash burn rate to support
continuing operations is approximately $8 million per year.
Additionally, we expect to accelerate the commercialization of
the
Eligen®
Technology in a cost effective way and to gain operational
efficiencies by tapping into advanced scientific processes
offered by independent contractors.
We are attempting to expand our current collaborative
relationships to take advantage of the critical knowledge that
others have gained by working with our technology. We will also
continue to pursue product candidates for internal development
and commercialization. We believe that these internal candidates
must be capable of development with reasonable investments in an
acceptable time period and with a reasonable risk-benefit
profile.
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Overall
Product Pipeline
Emisphere has a deep and varied pipeline that includes
prescription and nutritional supplement product candidates in
varying stages of development. Our product pipeline includes
prescription and medical food candidates. We have two
prescription products in Phase III studies, several in
Phase I and a number of pre-clinical (research stage) projects.
Some of the pre-clinical projects are partnered; others are
Emisphere-initiated. We continue to assess therapeutic molecules
for their potential compatibility with our technology and market
need. Our intent is to continue to expand our pipeline with
product candidates that demonstrate significant opportunities
for growth. Our focus is on molecules that meet the criteria for
success based on our increased understanding of our
Eligen®
Technology. Depending on the molecule, market potential and
interest, we intend to pursue potential product development
opportunities through development alliances or internal
development.
Vitamin
B12
The Company is developing an oral formulation of
Eligen®
B12 (1000 mcg) for use by B12 deficient individuals. During the
fourth quarter 2010, the Company completed a clinical trial
which showed that oral
Eligen®
B12 (1000 mcg) can efficiently and quickly restore Vitamin B12
levels in deficient individuals as effectively as the injectable
formulation, which is the current standard of care. The results
from that clinical trial have been submitted for publication. We
also conducted market research to help assess the potential
commercial opportunity for our potential
Eligen®
B12 (1000 mcg) product. Currently, we are evaluating the results
of our clinical trials and market research and exploring
alternative development and commercialization options with the
purpose of maximizing the commercial and health benefits
potential of our
Eligen®
B12 asset.
Vitamin B12 is an important nutrient that is poorly absorbed in
the oral form. In most healthy people, Vitamin B12 is absorbed
in a receptor-mediated pathway in the presence of an intrinsic
factor. A large number of people take B12 supplements by the
oral route, many in megadoses, and by injection. Currently, it
is estimated that at least five million people in the
U.S. are taking 40 million injections of Vitamin B12
per year to treat a variety of debilitating medical conditions.
Another estimated five million people are consuming more than
600 million tablets of Vitamin B12 orally. The
international market is larger than the U.S. market. Many
B12 deficient patients suffer from pernicious anemia and
neurological disorders and many of them are infirm or elderly.
Vitamin B12 deficiency can cause severe and irreversible damage,
especially to the brain and nervous system. At levels only
slightly lower than normal, a variety of symptoms such as
fatigue, depression, and poor memory may be experienced.
During April 2010, the Company had announced that interim data
from its recently completed study demonstrated that its oral
Eligen®
B12 (1000 mcg) given to individuals with low B12 levels restored
normal B12 serum concentrations. Normal levels of serum B12 were
achieved by all study participants who had taken oral
Eligen®
B12 (1000 mcg) 15 days into the
90-day study
when the first blood samples were taken. This data, in Abstract
Number 8370, was presented at the Experimental Biology 2010
Conference in Anaheim, California. In this open-label,
randomized, parallel-group,
90-day
study, serum cobalamin (B12) and holotranscobalamin (active B12)
were collected and measured at Baseline, Day 15, Day 31, Day 61
and Day 91. A total of 49 study participants were enrolled (26
on IM injection and 23 on oral) and received either nine 1000
mcg intramuscular injections of Vitamin B12 or once daily
tablets of oral
Eligen®
B12 (1000 mcg). The results from the interim analysis showed
that serum cobalamin and active B12 returned to the normal range
with both products and normalization was maintained. With
participants in the oral
Eligen®
B12 (1000 mcg) group showing the ability to rapidly achieve
normalized serum and active B12 levels, the study illustrates
the potential of the
Eligen®
Technology and of the high dose, oral
Eligen®
B12 (1000 mcg) formulation to offer a much needed alternative to
painful and inconvenient IM injections.
Emisphere developed
Eligen®
B12 independently, as a nutritional supplement product
candidate. During November 2009, the Company launched its first
commercially available product, oral
Eligen®
B12 (100 mcg), which had been specifically developed to help
improve Vitamin B12 absorption and bioavailability with a
patented formulation. During the third quarter 2010, we
terminated our distributor agreement for the
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marketing, distribution and sale of oral
Eligen®
B12 (100mcg) with Quality Vitamins and Supplements, Inc. to
allow us to focus on the development of the higher dose, oral
formulation of
Eligen®
B12 (1000 mcg) to be offered for B12 deficient patients.
Following pre-clinical pharmacokinetic studies in rats during
which the absorption profile of Vitamin B12 using our
Eligen®
Technology was assessed and compared to control (B12 alone),
additional preclinical studies using dogs further demonstrated
that the
Eligen®
Technology significantly enhances the absorption of oral B12. We
completed our first clinical study in 20 normal healthy males
which tested our new Vitamin B12 formulation against a
commercially available oral formulation
The data from our first pharmacokinetic study showed mean
Vitamin B12 peak blood levels were more than 10 times higher for
the
Eligen®
B12 5mg formulation than for the 5mg commercial formulation. The
mean time to reach peak concentration
(Tmax)
was reduced by over 90%, to 0.5 hours for the
Eligen®
B12 5mg from 6.8 hours for the commercial 5mg product.
Improvement in bioavailability was approximately 240%, with
absorption time at 30 minutes and a mean bioavailability of 5%.
The study was conducted with a single administration of
Eligen®
B12. There were no adverse reactions, and
Eligen®
B12 was well-tolerated.
In May 2009, the Company was informed by an independent expert
panel of scientists that its SNAC carrier had been provisionally
designated as GRAS for its intended application in combination
with nutrients added to food and dietary supplements. Following
a comprehensive evaluation of research and toxicology data,
Emispheres SNAC was found to be safe at a dosage up to
250 mg per day when used in combination with nutrients to
improve their dietary availability. In July 2009, concurrent
with the publication of two papers in the July/August issue of
the peer reviewed journal, International Journal of
Toxicology, which describes the toxicology of its SNAC
carrier, SNAC achieved GRAS status for its intended use in
combination with nutrients added to food and dietary
supplements. The publication of those two papers in the
International Journal of Toxicology was the final,
necessary step in the process of obtaining GRAS status for its
SNAC carrier. Since SNAC achieved GRAS status, it is exempt from
pre-market approval for its intended use in combination with
nutrients added to food and dietary supplements. This opens the
way for the potential commercialization of the
Eligen®
Technology with other substances such as vitamins.
During April 2009, we announced a strategic alliance with
AAIPharma, Inc. intended to expand the application of
Emispheres
Eligen®
Technology and AAIPharmas drug development services.
AAIPharma is a global provider of pharmaceutical product
development services that enhance the therapeutic performance of
its clients drugs. AAIPharma works with many
pharmaceutical and biotech companies and currently provides drug
product formulation development services to Emisphere. This
relationship expands our access to new therapeutic candidates
for the
Eligen®
Technology, which potentially could lead to new products and to
new alliance agreements as well.
We have obtained patents for the carrier we are using in the
oral B12 formulation and have filed applications covering the
combination of the carrier and many other compounds, including
Vitamin B12.
Phase III Programs
On the prescription side of our business, both of our products
in Phase III are with our partner Novartis, which is using
our drug delivery technology in combination with salmon
calcitonin, parathyroid hormone, and human growth hormone. Their
most advanced programs are testing oral formulations of salmon
calcitonin to treat osteoarthritis and osteoporosis. Novartis
completed the first Phase III clinical study for
osteoarthritis, and the second Phase III clinical study for
osteoarthritis is continuing. Novartis is also conducting a
Phase III clinical study for osteoporosis. In its Annual
Results Conference Media Release for the period ended
December 31, 2010, Novartis reported that its planned
submissions for oral calcitonin for the treatment of
osteoporosis and osteoarthritis are scheduled to be filed with
the regulatory authorities during 2011. During October 2010 the
Company announced that Novartis provided us with information
regarding the first interpretable results of the two-year
Phase III Study 2301 in osteoarthritis conducted by its
license partner, Nordic Bioscience, with oral calcitonin. The
recently completed study assessed the safety and efficacy of
oral calcitonin in the treatment of osteoarthritis of the knee
and had three co-primary endpoints. Novartis informed Emisphere
that preliminary analysis of the data from this study shows that
the endpoint for the first of three
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co-primary endpoints, joint space width narrowing, was not met.
Novartis also informed Emisphere that results regarding the
other two co-primary endpoints indicated clinical efficacy
related to symptom modification (WOMAC scales: pain, function).
In addition, according to Novartis, MRI analyses suggested an
effect on cartilage. Nordic Bioscience and Novartis have
indicated that they are going to continue to work together to
further analyze and evaluate the results of this study. The
second two-year Phase III Study 2302, which also assesses
safety and efficacy of oral calcitonin of patients with
osteoarthritis of the knee, is currently ongoing. Additionally,
the Phase III clinical program of oral calcitonin in
osteoporosis continues.
During July 2010, we announced that Novartis and its license
partner, Nordic Bioscience, reported the following in connection
with their Phase III Study 2302 in osteoarthritis assessing
the safety and efficacy of oral calcitonin in the treatment of
osteoarthritis of the knee. An independent Data Monitoring
Committee (DMC) conducted a futility analysis of
one-year data for all patients enrolled in this two-year study,
including assessments of safety and efficacy parameters. The DMC
concluded that although there was no reason to stop Study 2302
because of safety concerns, there was also no reason to continue
the study for efficacy. The DMC also concluded that the final
decision whether to continue Study 2302 rests with Novartis and
Nordic Bioscience. They currently intend to continue the
clinical program of oral calcitonin in osteoarthritis,
Phase III Study 2301 was completed and Phase III Study
2302 is continuing. Novartis and Nordic Bioscience continue to
work together to assess next steps.
During April 2010, we announced the publication of a research
study entitled Investigation of the Direct Effect of
Salmon Calcitonin on Human Osteoarthritic Chondrocytes, by
Nordic Bioscience in the April 5, 2010 edition of the
publication BMC Musculoskeletal Disorders. Oral salmon
calcitonin, which uses Emispheres proprietary
Eligen®
Technology, is currently being studied in osteoarthritis and
osteoporosis by Novartis and Nordic Bioscience. The study was
conducted in vitro on cartilage samples obtained
from female patients undergoing total knee arthroplasty surgery
for the treatment of osteoarthritis. The article describes the
growth promoting effects of salmon calcitonin on these cartilage
samples. The study shows that treatment with pharmacological
concentrations of calcitonin increases synthesis of both
proteoglycan (proteins and sugars which interweave with
collagen) and collagen type II the key components of
articular cartilage. This research is unique and significant as
it represents the first work to look chiefly at the ability of
salmon calcitonin to stimulate cartilage synthesis. These
findings provide evidence to substantiate the theory that
calcitonin may exert a positive effect on joint health through
its dual action of promoting both bone and cartilage formation.
During December 2009, we announced a meta-analysis published in
the December 2009 edition of Rheumatology Reports
examining independent evidence of the analgesic action of
the hormone calcitonin. This publication restated the potential
of calcitonin in filling a significant unmet need for
alternative treatments for persistent musculoskeletal pain.
Scientists from Nordic Bioscience were involved in the
preparation of this meta-analysis. Non-malignant musculoskeletal
pain is the most common clinical symptom that causes patients to
seek medical attention and is a major cause of disability in the
world. Musculoskeletal pain can arise from a variety of common
conditions including osteoarthritis, rheumatoid arthritis,
osteoporosis, surgery, low back pain and bone fracture. The
meta-analysis, conducted by researchers at the Center for
Sensory-Motor Interaction in the Department of Health Science
and Technology at Aalborg University in Denmark, examined
independent pre-clinical and clinical studies spanning nearly
45 years of the possible intrinsic analgesic properties of
calcitonin, with special focus on the challenges in the
musculoskeletal system. The authors concluded that well-designed
clinical trials should be conducted to further validate evidence
of calcitonins analgesic action and its promising
potential role in the management of musculoskeletal pain. The
effects of calcitonin on clinical pain conditions have received
increasing attention in the past decades, although a consensus
on
mechanism-of-action
and potential indications has not been reached. The analgesic
activity of oral salmon calcitonin has been shown in several
controlled prospective double-blind studies; besides pain
management in osteoporosis, calcitonin has shown analgesic
action in painful conditions such as phantom limb pain, diabetic
neuropathy, complex regional pain syndrome, adhesive capsulitis,
rheumatoid arthritis, vertebral crush fractures, spondylitis,
tumor metastasis, cancer pain, migraine, Pagets disease of
bone as well as post-operative pain. An ideal treatment with an
optimal efficacy, safety and convenience profile is not
available for the musculoskeletal pain associated with such
conditions as osteoporosis and osteoarthritis. This review of
the
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literature highlights the clear unmet medical need that could be
addressed by Emispheres oral salmon calcitonin product.
Phase I Programs
Emisphere also has several products in Phase I and a number of
pre-clinical (research stage) projects. Some of the pre-clinical
projects are partnered and others were initiated by the Company.
For the treatment of diabetes, research using the
Eligen®
Technology and GLP-1 (Glucagon-Like
Peptide-1),
a potential treatment for Type 2 diabetes, is being conducted by
Novo Nordisk. Emisphere had previously conducted extensive tests
on native insulin and native GLP-1which demonstrated that both
macromolecules can be effectively delivered using the
Eligen®
Technology. With the progress that has been made in the
development of second generation proteins, we concluded that a
more productive pathway is to move forward with GLP-1 analogs,
an oral form of which might be used to treat Type 2 diabetes and
related conditions. Our research indicated that the development
of oral formulations of Novo Nordisk proprietary GLP-1 receptor
agonists may represent an opportunity for Emisphere.
Consequently, on June 21, 2008 we entered into an exclusive
Development and License Agreement with Novo Nordisk focused on
the development of oral formulations of Novo Nordisks
proprietary GLP-1 receptor agonists (the GLP-1 License
Agreement). Under the GLP-1 License Agreement Emisphere
could receive more than $87 million in contingent product
development and sales milestone payments including a
$10 million non-refundable license fee which was received
during June 2008. Emisphere would also be entitled to receive
royalties in the event Novo Nordisk commercializes products
developed under such agreement. Under the terms of the
agreement, Novo Nordisk is responsible for the development and
commercialization of the products. Initially Novo Nordisk is
focusing on the development of oral formulations of its
proprietary GLP-1 receptor agonists.
During January 2010, we announced that Novo Nordisk had
initiated its first Phase I clinical trial with a long-acting
oral GLP-1 analog (NN9924). This milestone released a
$2 million payment to Emisphere, whose proprietary
Eligen®
Technology is used in the formulation of NN9924. GLP-1 is a
natural hormone involved in controlling blood sugar levels. It
stimulates the release of insulin only when blood sugar levels
become too high. GLP-1 secretion is often impaired in people
with Type 2 diabetes. The aim of this trial, which is being
conducted in the UK, is to investigate the safety, tolerability
and bioavailability of NN9924 in healthy volunteers. The trial
will enroll approximately 155 individuals and results from the
trial are expected in 2011. There are many challenges in
developing an oral formulation of GLP-1, in particular obtaining
adequate bioavailability. NN9924 addresses some of these key
challenges by utilizing Emispheres
Eligen®
Technology to facilitate absorption from the gastrointestinal
tract.
Novartis is engaged in research using the
Eligen®
Technology and PTH-1-34 to develop a safe and effective oral
formulation of Parathyroid Hormone (PTH) for the
treatment of postmenopausal osteoporosis. PTH is produced by the
parathyroid glands to regulate the amount of calcium and
phosphorus in the body. When used therapeutically, it increases
bone density and bone strength to help prevent fractures. It is
approved to treat osteoporosis, a disease associated with a
gradual thinning and weakening of the bones that occurs most
frequently in women after menopause. Untreated postmenopausal
osteoporosis can lead to chronic back pain, disabling fractures,
and lost mobility. Novartis conducted a Phase I study in
postmenopausal women to determine the safety and tolerability of
oral PTH-1-34, a combination of human PTH-1-34 and
Emispheres delivery agent 5-CNAC (5-CNAC), for
the treatment of postmenopausal osteoporosis. The study was
designed to assess the bioavailability profile of increasing
doses of PTH-1-34 combined with different amounts of 5-CNAC
administered orally. The results from the single-center,
partially-blinded, incomplete cross-over study were presented
October 19, 2009 in a poster session at the
73rd Annual Scientific Meeting of the American College of
Rheumatology in Philadelphia, PA. The results demonstrated that
a single dose of the novel oral parathyroid hormone PTH-1-34,
which utilizes Emispheres proprietary
Eligen®
drug delivery technology and absorption-enhancing carrier
molecule 5-CNAC, achieved potentially therapeutically relevant
exposure and safety profiles similar to those of the currently
available injectable formulation in healthy postmenopausal women.
During April 2010, we announced that Novartis initiated a second
Phase I trial for an oral PTH-1-34 which uses Emispheres
Eligen®
Technology, and is in development for the treatment of
postmenopausal
8
osteoporosis. The study is a partially blinded, placebo
controlled, active comparator study to explore the safety,
tolerability, pharmacokinetics and pharmacodynamics in
postmenopausal women after daily oral doses of PTH-1-34. The
study has two parts (A and B) and will enroll a total of
approximately up to 120 postmenopausal women. In Part A of
the trial, ascending doses of oral PTH-1-34 using the
Eligen®
Technology will be tested for safety, tolerability and
pharmacokinetics and compared to
Forsteo®.
In Part B, in addition to safety and tolerability of oral
PTH-1-34 using the
Eligen®
Technology, pharmacodynamic responses will be measured by bone
biomarker levels and bone mineral density, and compared to
Forsteo®.
The first patient was enrolled in April 2010.
During June 2008, Novartis launched a Phase I study in
postmenopausal women to determine the safety and tolerability of
oral PTH-1-34, a combination of human PTH-1-34 and the
absorption enhancer 5-CNAC using Emispheres proprietary
Eligen®
Technology, for the treatment of postmenopausal osteoporosis.
The study is designed to assess the bioavailability profile of
increasing doses of PTH-1-34 combined with different amounts of
5-CNAC administered orally. The trial was conducted in
Switzerland and its first interpretable results were released
during November 2008. The results of the study demonstrated the
achievement of a suitable PK profile of a new oral formulation
of PTH using Emispheres
Eligen®
Technology. This initial study of 20 healthy postmenopausal
female patients aged 40 to 70 years resulted in peak
concentrations
(Cmax)
in the range of those obtained with the commercially available
subcutaneous formulation
Forsteo®
(teriparatide). This initial trial reported no significant
adverse affects, no hypocalcaemia, and no drug-exposure related
discontinuation. Recombinant PTH, currently approved for the
treatment of osteoporosis, is available only by injection. PTH
exists naturally in the body; it increases bone density and bone
strength to help prevent fractures. It may also be used to treat
osteoporosis in patients at high risk of bone fracture.
Novartis has also conducted Phase I studies with oral salmon
calcitonin. During September 2009, Novartis and its partner
Nordic Bioscience issued study results in which twice-daily oral
salmon calcitonin using Emispheres proprietary
Eligen®
drug delivery technology significantly suppressed markers of
cartilage and bone degradation versus placebo in men and women
with osteoarthritis, the most common form of arthritis. The
study, a Phase I, placebo-controlled, double-blind,
double-dummy, randomized, gender-stratified clinical trial, was
conducted on behalf of Emispheres partner, Novartis, by
Nordic Bioscience, and was published online in the September
2009 issue of Osteoarthritis and Cartilage. A total of 73
male and female subjects aged 57 to 75 years with painful
osteoarthritis of the knee, received twice-daily 0.6 mg or
0.8 mg doses of oral salmon calcitonin with the
Eligen®
Technology or placebo administered over 14 days. Doses of
0.8mg compared with 0.6mg produced significantly higher
Cmax
and AUC(0-4 hrs), of calcitonin, P=0.03. This resulted in
significant reductions in CTX-I and CTX-II, which are
biochemical markers of bone degradation and of cartilage
degradation, respectively. Gender had no observable influence on
results. Oral sCT doses were well tolerated; 44 adverse events
and no serious adverse events were reported in this study. For
further details, please consult the original publication which
is available online (Karsdal MA et al; The effect of oral salmon
calcitonin delivered with 5-CNAC on bone and cartilage
degradation in osteoarthritic patients: a
14-day
randomized study; Osteoarthritis and Cartilage; available
online September 1, 2009). Emerging data continue to
indicate oral salmon calcitonin in combination with the
Companys absorption-enhancing
Eligen®
Technology may be a potential therapeutic option for women and
men with osteoarthritis, which affects more than 20 million
people in the United States.
A study conducted by Novartis and Nordic Bioscience published in
the December 2008 issue of BMC Clinical Pharmacology
demonstrated that orally administered salmon calcitonin
using Emispheres carrier, (5-CNAC) an
Eligen®
oral delivery technology, is effective in reducing bone
breakdown. The randomized, double-blind, double-dummy,
placebo-controlled study among 81 subjects in Copenhagen was
conducted on behalf of Emispheres partner Novartis by
Nordic Bioscience by M.A. Karsdal, I. Byrjalsen, B.J. Riis and
C. Christiansen. The study suggests that orally administered
0.8 mg of salmon calcitonin was effective in suppression of
Serum CTX irrespective of time of dosing. Serum CTX-1 (Serum
C-terminal telo-peptide of collagen type I) is the
biochemical marker used to measure bone resorption. There were
no safety concerns with the salmon calcitonin oral formulation
using Emispheres carrier 5-CNAC, which had been previously
demonstrated in earlier studies.
9
A study conducted by Novartis and Nordic Bioscience published in
the October 2008 issue of BMC Clinical Pharmacology
demonstrated that oral salmon calcitonin using
Emispheres proprietary
Eligen®
Technology taken 30 to 60 minutes before meals with 50 ml of
water results in improved absorption and improved efficacy
measured by the biomarker of reduced bone resorption (sCTX-I)
compared to the commonly prescribed nasal formulation. The study
was a randomized, partially-blind, placebo-controlled,
single-dose exploratory crossover clinical trial conducted with
56 healthy postmenopausal women.
Professor Christoph Beglinger, M.D., of the Clinical
Research Center, Department of Biomedicine Division of
Gastroenterology, and Department of Clinical Pharmacology and
Toxicology at University Hospital in Basel, Switzerland is also
conducting research assessing the feasibility of using the
Eligen®
Technology combined with PYY3-36 and native GLP-1, as a
potential treatment for obesity. During September 2010, we
announced that a clinical study conducted by Professor Beglinger
found that the Companys proprietary oral SNAC, in
combination with two digestive hormones, was successful in
reducing food intake and increasing satiety in healthy male
subjects. The study was published in the August 18, 2010,
online edition of the American Journal of Clinical
Nutrition, the official publication of the American Society
for Nutrition. As described in the publication, 12 healthy male
subjects were studied in a randomized double-blind,
placebo-controlled 4-way crossover trial. Each subject received
(in random order) 2.0 mg Native GLP-1, 1.0 mg PYY3-36,
or 2.0 mg Native GLP-1, plus 1.0 mg PYY3-36.
Researchers observed that both digestive hormones, native GLP-1
and PYY3-36, were rapidly absorbed from the gut, leading to
plasma concentrations several times higher than those in
response to a normal meal. Native GLP-1 alone, but not PYY3-36,
significantly reduced total food intake. Co-administration of
both hormones, taken in combination with SNAC in a single oral
dose, reduced both total food intake by 21.5 percent, and
increased fullness at meal onset (P <0.05). The
24-hour food
intake was not affected by the single oral administration of the
native hormones likely due to their short half-life. The two
digestive hormones utilized in the study are released naturally
in proportion to ingested calories and signal satiety, or
fullness, to the brain. SNAC, which is based on Emispheres
Eligen®
Technology, facilitates transport of these and other hormones
with low oral bioavailability across biological membranes, such
as those of the gastrointestinal tract. Emisphere had previously
announced that SNAC had achieved GRAS status for its intended
use in combination with nutrients added to food and dietary
supplements.
An article published in the September 2009 issue of Clinical
Pharmacology and Therapeutics describes previously reported
findings of an independent clinical study designed to assess the
pharmacokinetics, pharmacodynamics (PK/PD) and safety of oral
administration of the peptide GLP-1 utilizing Emispheres
Eligen®
carrier technology. The study was conducted at the University
Hospital in Basel, Switzerland by Professor Beglinger. The
paper, titled Orally Administered Glucagon-Like Peptide-1
Affects Glucose Homeostasis Following an Oral Glucose Tolerance
Test in Healthy Male Subjects, was published by Steinert,
et.al. Publication of this data in a prominent peer reviewed
journal underscores the potential of the
Eligen®
Technology to transform oral peptide delivery. Specifically, the
data further supports the concept of the potential advantages of
utilizing GLP-1 and similar molecules as therapeutic agents in
the treatment of Type 2 diabetes. As described in the
publication, a randomized, double-blind, placebo-controlled,
two-way crossover trial was conducted in 16 healthy male
subjects between the ages of 20 and 43. The study was designed
to investigate the PK/PD effects of a single dose (2 mg) of
oral GLP-1 formulated with Emispheres SNAC carrier
(150 mg) and administered 15 minutes prior to an oral
glucose tolerance test. The published data show that the orally
administered peptide, when administered with Emispheres
SNAC carrier, is rapidly absorbed from the gastrointestinal
tract, leading to tenfold higher plasma concentrations compared
to control. The pharmacodynamic effects were consistent with the
known pharmacology of GLP-1, resulting in significantly
increased basal insulin release (P< 0.027) and marked
effects on glucose levels. The postprandial glucose peak was
delayed with GLP-1, suggesting an effect on gastric emptying. No
adverse events were reported.
Intravenous or subcutaneous applications of therapeutic peptide
molecules are cumbersome and impractical for chronic treatment
regimens. Current oral application of peptides is ineffective
because peptides have a low oral bioavailability due to their
molecular size and physico-chemical characteristics. Professor
Beglingers studies show that Emispheres
Eligen®
Technology can overcome some of these oral delivery issues
safely and efficiently.
10
Preclinical Programs
Our other product candidates in development are in earlier or
preclinical research phases, and we continue to assess them for
their compatibility with our technology and market need. Our
intent is to seek partnerships with pharmaceutical and
biotechnology companies for certain of these products as we
continue to expand our pipeline with product candidates that
demonstrate significant opportunities for growth. Our focus is
on molecules that meet the criteria for success based on our
increased understanding of our
Eligen®
Technology. Our preclinical programs focus on the development of
oral formulations of potentially new treatments for diabetes and
products in the areas of cardiovascular, appetite suppression
and pain and on the development and potential expansion of
nutritional supplement products.
During December 2010, the Company entered into the Insulin
Agreement to develop and commercialize oral formulations of Novo
Nordisks insulins using Emispheres
Eligen®
Technology. This was the second license agreement between the
two companies. The GLP-1 License Agreement was signed in June
2008, with a potential drug currently in a Phase I clinical
trial. Please refer to Phase I Programs
(above). The Insulin agreement included $57.5 million in
potential product development and sales milestone payments to
Emisphere, of which $5 million was paid upon signing, as
well as royalties on sales. This extended partnership with Novo
Nordisk has the potential to offer significant new solutions to
millions of people with diabetes worldwide and it also serves to
further validate our
Eligen®
Technology.
During March 2010, Emisphere and Alchemia Ltd. (ASX: ACL)
announced that they would join efforts to develop an oral
formulation of the anti-coagulant drug fondaparinux with
Emispheres
Eligen®
Technology. Fondaparinux, an anti-coagulant used for the
prevention of deep vein thrombosis, is marketed in injectable
form as
Arixtra®
by GlaxoSmithKline.
Arixtra®
has been off patent since 2002 but, due to the complexity of its
synthesis, there is currently no approved generic or alternative
source of commercial scale active pharmaceutical ingredient
(API). Alchemia has developed a novel, patent
protected, synthesis for the manufacture of fondaparinux at
commercial scale. In March 2009 Alchemias manufacturing
and U.S. marketing partner, Dr. Reddys Laboratories
(NYSE: RDY), submitted an ANDA to the U.S. FDA for a
generic version of the injectable form of fondaparinux. We
believe an oral formulation of fondaparinux could dramatically
increase the market potential for fondaparinux. Based on what we
know from our experience with other chemically-related
anti-coagulants, the profile of fondaparinux should fit very
well with the
Eligen®
Technology given its half life and safety profile. Although
developing an oral formulation of an injectable compound is
always challenging, this project could produce substantial
benefits for the medical community. The combination of
Emispheres delivery technology and Alchemias
fondaparinux may ultimately allow us to bring an oral
anti-coagulant to market in an accelerated fashion. Alchemia has
already seen preclinical data suggesting that enhanced levels of
oral absorption can be achieved for fondaparinux. If the dose
formulated with the
Eligen®
Technology can be successfully optimized, it could open up a
host of medically and commercially compelling opportunities for
fondaparinux, Alchemia plans to evaluate a number of different
formulations initially in order to optimize oral bioavailability
and pharmacokinetics, with the aim of then rapidly moving into
human clinical studies.
Business
Financing
Since our inception in 1986, we have generated significant
losses from operations and we anticipate that we will continue
to generate significant losses from operations for the
foreseeable future. However, during 2010 we expanded our
relationship with our development partner, Novo Nordisk, and
negotiated the cancellation of our current debt obligation with
our development partner, Novartis, as described below under the
heading Ongoing Collaborative Agreements and
also completed the August 2010 Financing (as defined below).
On August 25, 2010, the Company entered into a securities
purchase agreement (together with the securities purchase
agreement with MHR, as defined below, the August 2010
Financing) with certain institutional investors pursuant
to which the Company agreed to sell an aggregate of
3,497,528 shares of its common stock and warrants to
purchase a total of 2,623,146 additional shares of its common
stock for total gross proceeds of $3,532,503. Each unit,
consisting of one share of common stock and a warrant to
purchase
11
0.75 shares of common stock, was sold at a purchase price
of $1.01. The warrants to purchase additional shares are
exercisable at a price of $1.26 per share and will expire
5 years from the date of issuance. In accordance with the
terms of a registration rights agreement with the investors, the
Company filed a registration statement on September 15,
2010, which was declared effective October 12, 2010. On
August 25, 2010, the Company also announced that it had
entered into a separate securities purchase agreement with MHR
Fund Management LLC (together with its affiliates,
MHR) as part of the August 2010 Financing, pursuant
to which the Company agreed to sell an aggregate of
3,497,528 shares of its common stock and warrants to
purchase a total of 2,623,146 additional shares of its common
stock for total gross proceeds of $3,532,503. Each unit,
consisting of one share of common stock and a warrant to
purchase 0.75 shares of common stock, was sold at a
purchase price of $1.01. The warrants to purchase additional
shares are exercisable at a price of $1.26 per share and will
expire 5 years from the date of issuance.
The Company received total net proceeds from the August 2010
Financing of approximately $6.7 million after deducting
fees and expenses and excluding the proceeds, if any, from the
exercise of the warrants that will be issued in the
transactions. Proceeds from these transactions will be used to
fund the Companys operations (including investments in new
product development and commercialization), to satisfy certain
debts of the Company, to settle certain outstanding litigation
and to meet the Companys obligations as they may arise.
In connection with the August 2010 Financing, the Company
entered into a waiver agreement with MHR (the Waiver
Agreement), pursuant to which MHR waived certain
anti-dilution adjustment rights under its 11% senior
secured notes and warrants issued by the Company to MHR in
September 2006 that would otherwise have been triggered by the
private placement described above. As consideration for such
waiver, the Company issued to MHR a warrant to purchase
975,000 shares of common stock and agreed to reimburse MHR
for 50% of its legal fees up to a maximum reimbursement of
$50,000. The terms of such warrant are identical to the warrants
issued to MHR in the August 2010 Financing transaction described
above. The Company was advised in these transactions by an
independent committee of the Companys board of directors
(the Board of Directors). Roth Capital Partners
served as the placement agent for the offering.
As of December 31, 2010, our accumulated deficit was
approximately $480.9 million. Our loss from operations was
$11.5 million, $14.6 million and $26.3 million
for the years ended December 31, 2010, 2009 and 2008,
respectively. Our net loss was $56.9 million,
$16.8 million and $24.4 million for the years ended
December 31, 2010, 2009 and 2008, respectively. Our net
cash outlays from operations and capital expenditures were
$4.9 million, $11.9 million and $6.8 million for
the years ended December 31, 2010, 2009 and 2008,
respectively. Net cash outlays include receipts of deferred
revenue of $7.1 million, and $0.2 million for 2010 and
2009, respectively. Our stockholders deficit was
$82.5 million and $35.2 million as of
December 31, 2010 and 2009, respectively.
We have limited capital resources and operations to date have
been funded with the proceeds from collaborative research
agreements, public and private equity and debt financings and
income earned on investments. We anticipate that we will
continue to generate significant losses from operations for the
foreseeable future, and that our business will require
substantial additional investment that we have not yet secured.
As such, we anticipate that our existing capital resources will
enable us to continue operations through approximately June 2011
or earlier if unforeseen events or circumstances arise that
negatively affect our liquidity. Further, we have significant
future commitments and obligations. While our plan is to raise
capital when needed
and/or to
pursue partnering opportunities, we cannot be sure that our
plans will be successful. These conditions raise substantial
doubt about our ability to continue as a going concern.
Consequently, the audit reports prepared by our independent
registered public accounting firms relating to our financial
statements for the years ended December 31, 2010, 2009 and
2008 include an explanatory paragraph expressing the substantial
doubt about our ability to continue as a going concern. We are
pursuing new as well as enhanced collaborations and exploring
other financing options, with the objective of minimizing
dilution and disruption. If we fail to raise additional capital
or obtain substantial cash inflows from existing partners prior
to early June 2011, we could be forced to cease operations.
12
If we are successful in raising additional capital to continue
operations, our business will still require substantial
additional investment that we have not yet secured. Further, we
will not have sufficient resources to fully develop new products
or technologies unless we are able to raise substantial
additional financing on acceptable terms or secure funds from
new or existing partners. We cannot assure you that financing
will be available on favorable terms or at all. For further
discussion, see Part I, Item 1A Risk
Factors.
Overview
of Drug Delivery Industry
The drug delivery industry develops technologies for the
improved administration of therapeutic molecules with the goal
of expanding markets for existing products and extending drug
franchises. Drug delivery companies also seek to develop
products on their own that would be patent-protected by applying
proprietary technologies to off-patent pharmaceutical products.
Primarily, drug delivery technologies are focused on improving
safety, efficacy, ease of patient use
and/or
patient compliance. Pharmaceutical and biotechnology companies
consider improved drug delivery as a means of gaining
competitive advantage over their peers.
Therapeutic macromolecules, of which proteins are the largest
sub-class,
are prime targets for the drug delivery industry for a number of
reasons. Most therapeutic macromolecules must currently be
administered by injection (most common) or other device such as
an inhaler or nasal spray system. Many of these compounds
address large markets for which there is an established medical
need. These drugs are widely used, as physicians are familiar
with them and accustomed to prescribing them. Therapeutic
macromolecules could be significantly enhanced through
alternative delivery. These medicines are comprised of proteins
and other large or highly charged molecules (carbohydrates,
peptides, ribonucleic acids) that, if orally administered using
traditional oral delivery methods, would degrade in the stomach
or intestine before they are absorbed into the bloodstream.
Also, these molecules are typically not absorbed following oral
administration due to their poor permeability. Therefore, the
vast majority are administered parenterally. However, for many
reasons, parenteral administration is undesirable, including
patient discomfort, inconvenience and risk of infection. Poor
patient acceptance of parenteral therapies can lead to medical
complications. In addition, parenteral therapies can often
require incremental costs associated with administration in
hospitals or doctors offices.
Previously published research indicates that patient acceptance
of and adherence to a dosing regimen is higher for orally
delivered medications than it is for non-orally delivered
medications. Our business strategy is partly based upon our
belief that the development of an efficient and safe oral
delivery system for therapeutic macromolecules represents a
significant commercial opportunity. We believe that more
patients will take orally delivered drugs more often, spurring
market expansion.
Leading
Current Approaches to Drug Delivery
Transdermal
(via the skin) and Needleless
Injection
The size of most macromolecules makes penetration into or
through the skin inefficient or ineffective. Some peptides and
proteins can be transported across the skin barrier into the
bloodstream using high-pressure needleless injection
devices. Needleless devices, which inject proteins through the
skin into the body, have been in development for many years. We
believe these devices have not been well accepted due to patient
discomfort, relatively high cost, and the inconvenience of
placing the drugs into the device.
Nasal
(via the nose)
The nasal route (through the membranes of the nasal passage) of
drug administration has been limited by low and variable
bioavailability for proteins and peptides. As a result,
penetration enhancers often are used with nasal delivery to
increase bioavailability. These enhancers may cause local
irritation to the nasal tissue and may result in safety concerns
with long-term use. A limited number of peptides delivered
nasally have been approved for marketing in the
U.S. including
MIACALCIN®,
developed by Novartis as an osteoporosis therapy, a therapeutic
area we have targeted.
13
Pulmonary
(via the lung)
Pulmonary delivery (through the membranes of the lungs) of drugs
is emerging as a delivery route for large molecules. Although
local delivery of respiratory drugs to the lungs is common, the
systemic delivery (i.e., delivery of the drugs to the peripheral
vasculature) of macromolecular drugs is less common because it
requires new formulations and delivery technologies to achieve
efficient, safe and reproducible dosing. Only one protein using
pulmonary delivery has been approved for marketing in the U.S.,
which is
EXUBERA®,
an insulin product developed by Pfizer and Nektar, as a diabetes
therapy, a therapeutic area we have targeted. However after
market acceptance of
EXUBERA®
was demonstrated to be limited, Pfizer withdrew from further
commercialization of, and terminated its license with Nektar for
EXUBERA®.
Intraoral
(via the membranes in the mouth)
Intraoral delivery is also emerging as a delivery route for
large molecules. Buccal delivery (through the membrane of the
cheek) and sublingual delivery (through the membrane under the
tongue) are forms of intraoral delivery. Some Vitamin B12
manufactures sell and distribute sublingual versions of their
product.
Oral
(via the mouth)
We believe that the oral method of administration is the most
patient-friendly option, in that it offers convenience, is a
familiar method of administration that enables increased
compliance and, for some therapies, may be considered the most
physiologically appropriate. We, and other drug delivery and
pharmaceutical companies, have developed or are developing
technologies for oral delivery of drugs. We believe that our
Eligen®
Technology provides an important competitive advantage in the
oral route of administration because it does not alter the
chemical composition of the therapeutic macromolecules. We have
conducted over 140,000 human dosings and have witnessed no
serious adverse events that can be attributed to the
EMISPHERE®
delivery agents dosed or the mechanism of action of the
Eligen®
Technology.
In general, we believe that oral administration will be
preferred to other methods of administration. However, such
preference may be offset by possible negative attributes of
orally administered drugs such as the quantity or frequency of
the dosage, the physical size of the capsule or tablet being
swallowed or the taste. For example, in our previous
Phase III trial with heparin as an oral liquid formulation,
patient compliance was hindered by patients distaste for
the liquid being administered. In addition, patients and the
marketplace will more likely respond favorably to improvements
in absorption, efficacy, safety, or other attributes of
therapeutic molecules. It is possible that greater convenience
alone may not lead to success.
Ongoing
Collaborative Agreements
We are a party to certain collaborative agreements with
corporate partners to provide development and commercialization
services relating to the products under collaboration. These
agreements are in the form of research and development
collaborations and licensing agreements. Under these agreements,
we have granted licenses or the rights to obtain licenses to our
oral drug delivery technology. In return, we are entitled to
receive certain payments upon the achievement of milestones and
royalties on the sales of the products should a product
ultimately be commercialized. We also are entitled to be
reimbursed for certain research and development costs that we
incur.
All of our collaborative agreements are subject to termination
by our corporate partners, without significant financial penalty
to them. Under the terms of these agreements, upon a termination
we are entitled to reacquire all rights in our technology at no
cost and are free to re-license the technology to other
collaborative partners.
Novartis
Pharma AG
On December 1, 2004, we issued a $10 million
convertible note (the Novartis Note) to Novartis in
connection with a research collaboration option relating to the
development of PTH-1-34. The Novartis Note was originally due
December 1, 2009. On November 27, 2009, Novartis
agreed to extend the maturity date of
14
the Novartis Note to February 26, 2010. Subsequently, on
February 23, 2010, Novartis agreed to further extend the
maturity date of the Novartis Note to May 26, 2010. On
May 27, 2010, Novartis agreed to a further extension
through June 4, 2010. On June 4, 2010, the Company and
Novartis entered into a Master Agreement and Amendment (the
Novartis Agreement). Pursuant to the Novartis
Agreement, the Company was released and discharged from its
obligations under the Novartis Note in exchange for:
(i) the reduction of future royalty and milestone payments
up to an aggregate amount of $11.0 million due the Company
under the Research Collaboration and Option Agreement, dated as
of December 3, 1997, as amended on October 20, 2000
(the Research Collaboration and Option Agreement),
and the License Agreement, dated as of March 8, 2000, for
the development of an oral salmon calcitonin product for the
treatment of osteoarthritis and osteoporosis (the Oral
Salmon Calcitonin License Agreement); (ii) the right
for Novartis to evaluate the feasibility of using
Emispheres
Eligen®
Technology with two new compounds to assess the potential for
new product development opportunities; and (iii) other
amendments to the Research Collaboration and Option Agreement
and License Agreement. As of the date of the Novartis Agreement,
the outstanding principal balance and accrued interest of the
Novartis Note was approximately $13.0 million. The Company
recognized the full value of the debt released as consideration
for the transfer of the rights and other intangibles to Novartis
and deferred the related revenue in accordance with applicable
accounting guidance for the sale of rights to future revenue
until the earnings process has been completed based on
achievement of certain milestones or other deliverables. If
Novartis chooses to develop oral formulations of these new
compounds using the
Eligen®
Technology, the parties will negotiate additional agreements. In
that case, Emisphere could be entitled to receive development
milestone and royalty payments in connection with the
development and commercialization of these potentially new
products.
Oral
Salmon Calcitonin (sCT) Program for Osteoporosis and
Osteoarthritis
Novartis most advanced program utilizing the
Companys
Eligen®
Technology is testing an oral formulation of calcitonin to treat
osteoarthritis and osteoporosis. For osteoarthritis, Novartis
completed one Phase III trial and is conducting a second
Phase III clinical study is continuing. Novartis is also
conducting a Phase III clinical study for osteoporosis.
With these Phase III studies, over 6,000 clinical study
patients used the
Eligen®
Technology during 2010 and approximately 5,500 continue to use
it during 2011. Please refer to the earlier description of
Phase III Programs a under the subject heading
Phase III Programs.
Osteoporosis
In December 1997, we entered into a collaboration agreement with
Novartis to develop an oral form of sCT, currently used to treat
osteoporosis (the sCT Agreement). sCT is a hormone
that inhibits the bone-tissue resorbing activity of specialized
bone cells called osteoclasts, enabling the bone to retain more
of its mass and functionality. sCT has demonstrated efficacy in
increasing lumbar spine bone mineral density and in reducing
vertebral fractures. sCT is estimated to be about 30 times more
potent than the human version. Synthetic sCT, which is identical
to the naturally occurring one, currently is available only as a
nasal spray or injectable therapy. Novartis markets synthetic
sCT in the U.S. as
MIACALCIN®
nasal spray, which is indicated for the treatment of
post-menopausal osteoporosis in women greater than five years
post menopause with low bone mass.
Treatment with sCT has been shown to increase bone mineral
density in the spine and reduce the risk of new vertebral
fractures in post-menopausal women with osteoporosis. It is also
used to treat Pagets disease, a disease that results in,
among other things, bone pain and breakdown. In its nasal spray
forms, it is believed that sCTs major advantages are its
efficacy resulting from a lack of serious side effects,
excellent long-term safety profile and ease of administration.
Some studies even suggest that sCT produces an analgesic effect.
Worldwide market sales for products to treat osteoporosis are
forecasted to reach $10.4 billion by 2011, from
approximately $5.0 billion in 2003.
Please refer to the earlier description of Novartis studies
relating to osteoporosis under the subject headings
Phase III Programs and Phase I
Programs.
15
Under the sCT Agreement, Novartis has an option to an exclusive
worldwide license to develop in conjunction with us, make, have
made, use and sell products developed under this program.
Novartis also had the right to exercise an option to commence a
research collaboration with us on a second compound under this
agreement. Novartis rights to certain specified financial
terms concerning a license of a second compound have since
expired. We have no payment obligations with respect to the sCT
Agreement; we are, however, obligated to collaborate with
Novartis by providing access to our technology that is relevant
to this program. We are also obligated to help to manage this
program through a joint steering committee with
Novartis.
According to the National Osteoporosis Foundation,
10 million people in the U.S. are estimated to have
the disease with 34 million more estimated to have low bone
mass and are, therefore, at risk. If successful, this product
candidate for the treatment of osteoporosis would satisfy an
unmet market need, with oral salmon calcitonin expected to offer
a safe, effective, and convenient alternative to existing
therapies.
Osteoarthritis
On a parallel track, Novartis is also pursuing an osteoarthritis
indication for salmon calcitonin. Approximately 21 million
patients are managed for osteoarthritis in the U.S. alone,
and that number is expected to increase as the baby boomer
generation continues to age. Osteoarthritis (OA) is
a clinical syndrome in which low-grade inflammation results in
joint pain, caused by a wearing-away of cartilage that cushions
the joints and the destruction or decrease of synovial fluid
that lubricates those joints. As OA progresses, pain can result
when the patient bears weight upon the joints, including walking
and standing. OA is the most common form of arthritis, and
affects nearly 21 million people in the U.S., accounting
for 25% of visits to primary care physicians, and half of all
non-steroidal anti-inflammatory drug prescriptions. It is
estimated that 80% of the population will have radiographic
evidence of OA by age 65.
Novartis was engaged in two, simultaneous Phase III trials
for salmon calcitonin in the treatment of osteoarthritis. Please
refer to the earlier description of Phase III Programs a
under the subject heading Phase III
Programs.
Novartis has also conducted Phase I studies with oral salmon
calcitonin. Please refer to the earlier description of Phase I
studies under the subject heading Phase I
Programs.
Oral
PTH-1-34 Program
On December 1, 2004, we entered into a Research
Collaboration Option and License Agreement with Novartis whereby
Novartis obtained an option to license our
Eligen®
Technology to develop safe and effective oral formulations of
PTH for the treatment of postmenopausal osteoporosis, PTH is
produced by the parathyroid glands to regulate the amount of
calcium and phosphorus in the body. When used therapeutically,
it increases bone density and bone strength to help prevent
fractures. It is approved to treat osteoporosis, a disease
associated with a gradual thinning and weakening of the bones
that occurs most frequently in women after menopause. Untreated
postmenopausal osteoporosis can lead to chronic back pain,
disabling fractures, and lost mobility. Novartis conducted a
Phase I study in postmenopausal women to determine the safety
and tolerability of oral PTH-1-34, a combination of human
PTH-1-34 and Emispheres delivery agent 5-CNAC, for the
treatment of postmenopausal osteoporosis. The study was designed
to assess the bioavailability profile of increasing doses of
PTH-1-34 combined with different amounts of 5-CNAC administered
orally. The results, from the single-center, partially-blinded,
incomplete cross-over study were presented October 19, 2009
in a poster session at the 73rd Annual Scientific Meeting
of the American College of Rheumatology in Philadelphia, PA.
Study results demonstrated that a single dose of the novel oral
parathyroid hormone PTH-1-34, which utilizes Emispheres
proprietary
Eligen®
drug delivery technology and absorption-enhancing carrier
molecule 5-CNAC, achieved potentially therapeutically relevant
exposure and safety profiles similar to those of the currently
available injectable formulation in healthy postmenopausal women.
Parathyroid hormone continues on a progressive clinical
development path in collaboration with Novartis. During April
2010, we announced that Novartis Pharma AG initiated a second
Phase I trial for an oral
PTH-1-34
which uses Emispheres
Eligen®
Technology, and is in development for the treatment of
16
postmenopausal osteoporosis. Please refer to the earlier
description of Phase I studies under the subject heading
Phase I Programs.
Oral
Recombinant Human Growth Hormone Program
From 1998 through August 2003, we developed oral rhGH in
collaboration with Eli Lilly and Company (Lilly). As
of August 2003, Lilly returned to us all rights to the oral rhGH
program pursuant to the terms of our license agreement. On
September 23, 2004, we announced a new partnership with
Novartis to develop our oral rhGH program. Under this
collaboration, we are working with Novartis to initiate clinical
trials of a convenient oral human growth hormone product using
the
Eligen®
Technology. On May 1, 2006, we announced that Novartis will
initiate the development of an oral rhGH product using
Emispheres
Eligen®
Technology.
Under this agreement, Novartis has an exclusive worldwide
license to develop, make, have made, use and sell products
developed under this program. We have no payment obligations
with respect to this program; we are, however, obligated to
collaborate with Novartis by providing access to our technology
that is relevant to this program. We are also obligated to help
to manage this program through a joint steering
committee with Novartis.
To date, we have received $6 million in non-refundable
payments from Novartis under this program, including the
$5 million milestone payment received in 2006. We may
receive up to $28 million in additional milestone payments
during the course of product development and royalties based on
sales.
Novo
Nordisk A/S
Insulin
Agreement
During December 2010, the Company entered into the Insulin
Agreement to develop and commercialize oral formulations of Novo
Nordisks insulins using Emispheres
Eligen®
Technology (the Insulin Agreement). This was the
second license agreement between the two companies. The GLP-1
License Agreement was signed in June 2008. The Insulin Agreement
included $57.5 million in potential product development and
sales milestone payments to Emisphere, of which $5 million
was paid upon signing, as well as royalties on sales. This
extended partnership with Novo Nordisk has the potential to
offer significant new solutions to millions of people with
diabetes worldwide and it also serves to further validate our
Eligen®
Technology.
GLP-1
Receptor Agonists Agreement
During June 2008, we entered into the GLP-1 License Agreement,
pursuant to which Novo Nordisk will develop and commercialize
oral formulations of Novo Nordisk proprietary GLP-1 receptor
agonists in combination with Emisphere carriers. Under the GLP-1
License Agreement, Emisphere could receive more than
$87 million in contingent product development and sales
milestone payments, including a $10 million non-refundable
license fee which was received in June 2008. Emisphere would
also be entitled to receive royalties in the event Novo Nordisk
commercializes products developed under such Agreement. Under
the GLP-1 License Agreement, Novo Nordisk is responsible for the
development and commercialization of the products.
During January 2010, we announced that Novo Nordisk had
initiated its first Phase I clinical trial with a long-acting
oral GLP-1 analog (NN9924). This milestone released a
$2 million payment to Emisphere, whose proprietary
Eligen®
Technology is used in the formulation of NN9924. GLP-1 is a
natural hormone involved in controlling blood sugar levels. It
stimulates the release of insulin only when blood sugar levels
become too high. GLP-1 secretion is often impaired in people
with Type 2 diabetes. The aim of this trial, which is being
conducted in the UK, is to investigate the safety, tolerability
and bioavailability of NN9924 in healthy volunteers. The trial
will enroll approximately 155 individuals and results from the
trial are expected in 2011. There are many challenges in
developing an oral formulation of GLP-1, in particular obtaining
adequate bioavailability. NN9924 addresses some of these key
challenges by utilizing Emispheres
Eligen®
Technology to facilitate absorption from the gastrointestinal
tract.
17
Oral
Gallium Program
In March 2006, we announced that we had entered into an
exclusive worldwide licensing agreement with Genta, Incorporated
(Genta) to develop an oral formulation of a
gallium-containing compound. Under the agreement, we will
utilize our
Eligen®
Technology to supply a finished oral dosage form to Genta. Genta
will be responsible for toxicology, clinical development,
regulatory submissions, and worldwide commercialization. In
addition to royalties on net sales of the product, Genta has
agreed to fund Emispheres development activities and
to pay performance milestones related to the filing and approval
of regulatory applications. An Investigational New Drug
application was filed by Genta for gallium on July 31,
2007. Genta released final results from the Companys Phase
I clinical trial of G4544, a new tablet formulation of a
proprietary small molecule intended as a treatment for diseases
associated with accelerated bone loss using delivery technology
developed by Emisphere Technologies, Inc. Results showed that
the drug was very well-tolerated, and that blood levels were
achieved in a range that is known to be clinically bioactive.
The data were featured in a poster session at the annual meeting
of the American Society of Clinical Oncology (ASCO)
in 2008.
Revenue
Recognized from Significant Collaborators during 2008 through
2010 (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborator
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
Novartis Pharma AG
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Novo Nordisk A/S
|
|
|
|
|
|
|
|
|
|
|
46
|
|
Genta
|
|
|
|
|
|
|
|
|
|
|
118
|
|
Research
and Development Costs
We have devoted substantially all of our efforts and resources
to research and development conducted on our own behalf
(self-funded) and in collaborations with corporate partners
(partnered). Generally, research and development expenditures
are allocated to specific research projects. Due to various
uncertainties and risks, including those described in
Part 1, Item 1A. Risk Factors
below, relating to the progress of our product candidates
through development stages, clinical trials, regulatory
approval, commercialization and market acceptance, it is not
possible to accurately predict future spending or time to
completion by project or project category.
The following table summarizes research and development spending
to date by project category:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
Year Ended December 31,
|
|
|
Spending
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
2010(1)
|
|
|
|
(In thousands)
|
|
|
Research(2)
|
|
$
|
50
|
|
|
$
|
70
|
|
|
$
|
1,143
|
|
|
$
|
51,968
|
|
Feasibility projects
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Self-funded
|
|
|
1,642
|
|
|
|
1,287
|
|
|
|
1,688
|
|
|
|
12,686
|
|
Partnered
|
|
|
34
|
|
|
|
38
|
|
|
|
425
|
|
|
|
4,258
|
|
Development projects
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral heparin (self-funded)
|
|
|
37
|
|
|
|
148
|
|
|
|
392
|
|
|
|
99,474
|
|
Oral insulin (self-funded)
|
|
|
|
|
|
|
3
|
|
|
|
53
|
|
|
|
21,287
|
|
Partnered
|
|
|
|
|
|
|
2
|
|
|
|
59
|
|
|
|
12,157
|
|
Other(3)
|
|
|
732
|
|
|
|
2,498
|
|
|
|
9,025
|
|
|
|
104,687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total all projects
|
|
$
|
2,495
|
|
|
$
|
4,046
|
|
|
$
|
12,785
|
|
|
$
|
306,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Cumulative spending from August 1, 1995 through
December 31, 2010. |
|
(2) |
|
Research is classified as resources expended to expand the
ability to create new carriers, to ascertain the mechanisms of
action of carriers, and to establish computer based modeling
capabilities, prototype formulations, animal models, and in
vitro testing capabilities. |
18
|
|
|
(3) |
|
Other includes indirect costs such as rent, utilities, training,
standard supplies and management salaries and benefits. |
Patents
and Other Forms of Intellectual Property
Our success depends, in part, on our ability to obtain patents,
maintain trade secret protection, and operate without infringing
the proprietary rights of others (Please refer to Part I,
Item 1A Risk Factors for further
discussion of how business will suffer if we cannot adequately
protect our patent and proprietary rights). We seek patent
protection on various aspects of our proprietary chemical and
pharmaceutical delivery technologies, including the delivery
agent compounds and the structures which encompass
Emispheres delivery agents, their method of preparation,
the combination of our compounds with a pharmaceutical, and use
of our compounds with therapeutic molecules to treat various
disease states. We have patents and patent applications in the
U.S. and certain foreign countries. As of March 1,
2011, Emisphere had been granted more than 110 U.S. patents
and more than 200 foreign patents. Emisphere also has more than
50 pending U.S. patent applications as well as more than
200 counterpart applications pending in foreign countries.
We intend to file additional patent applications when
appropriate and to aggressively prosecute, enforce, and defend
our patents and other proprietary technology.
We have five trademarks granted by the U.S. Patent and
Trademark office. They include
EMISPHERE®,
Elaprin®
(oral heparin), the Emisphere logo,
Emigent®
and
Eligen®.
We also rely on trade secrets, know-how, and continuing
innovation in an effort to develop and maintain our competitive
position. Patent law relating to the patentability and scope of
claims in the biotechnology and pharmaceutical fields is
evolving and our patent rights are subject to this additional
uncertainty. Others may independently develop similar product
candidates or technologies or, if patents are issued to us,
design around any products or processes covered by our patents.
We expect to continue, when appropriate, to file product and
other patent applications with respect to our inventions.
However, we may not file any such applications or, if filed, the
patents may not be issued. Patents issued to or licensed by us
may be infringed by the products or processes of others.
Defense and enforcement of our intellectual property rights can
be expensive and time consuming, even if the outcome is
favorable to us. It is possible that the patents issued to or
licensed to us will be successfully challenged, that a court may
find that we are infringing validly issued patents of third
parties, or that we may have to alter or discontinue the
development of our products or pay licensing fees to take into
account patent rights of third parties.
Manufacturing
The primary raw materials used in making the delivery agents for
our product candidates are readily available in large quantities
from multiple sources. In the past we manufactured delivery
agents internally using our own facilities on a small scale for
research purposes and for early stage clinical supplies. We
believed that our manufacturing capabilities complied with the
FDAs current Good Manufacturing Practice
(GMP). Beginning in 2004, we manufactured early
stage clinical supplies under GMP conditions for our oral
insulin program and heparin multiple arm studies. The FDA
inspected our in-house facilities in 2003 and again in 2005. The
2003 inspection resulted in only minor observations on
Form 483 which were quickly resolved to FDAs
satisfaction, while the 2005 inspection yielded no Form 483
observations.
Currently,
EMISPHERE®
delivery agents are manufactured by third parties in accordance
with GMP regulations. We have identified other commercial
manufacturers meeting the FDAs GMP regulations that have
the capability of producing
EMISPHERE®
delivery agents and we do not rely on any particular
manufacturer to supply us with needed quantities.
During April 2009, we announced a strategic alliance with
AAIPharma, Inc. intended to expand the application of
Emispheres
Eligen®
Technology and AAIPharmas drug development services.
AAIPharma is a global provider of pharmaceutical product
development services that enhance the therapeutic performance of
its clients drugs. AAIPharma works with many
pharmaceutical and biotech companies and currently provides
19
drug product formulation development services to Emisphere. This
relationship expands our access to new therapeutic candidates
for the
Eligen®
Technology, which potentially could lead to new products and to
new alliance agreements as well. We are also pleased that a
global provider of pharmaceutical product development services
with the stature of AAIPharma has chosen to combine with
Emisphere in a synergistic alliance that will benefit both
organizations. This strategic alliance supports AAIPharmas
strategy to offer drug delivery options to its pharmaceutical
and biotech customers.
Competition
Our success depends in part upon maintaining a competitive
position in the development of product candidates and
technologies in an evolving field in which developments are
expected to continue at a rapid pace. We compete with other drug
delivery, biotechnology and pharmaceutical companies, research
organizations, individual scientists and non-profit
organizations engaged in the development of alternative drug
delivery technologies or new drug research and testing, and with
entities developing new drugs that may be orally active. Our
product candidates compete against alternative therapies or
alternative delivery systems for each of the medical conditions
our product candidates address, independent of the means of
delivery. Many of our competitors have substantially greater
research and development capabilities, experience, marketing,
financial and managerial resources than we have. In many cases
we rely on our development partners to develop and market our
product candidates.
Oral
Osteoporosis Competition
An injectable form of PTH-1-34 is manufactured and sold by Eli
Lilly, as
FORTEO®.
Unigene Laboratories, Inc. (Unigene) has reported
that, in collaboration with GlaxoSmithKline plce
(GSK), it is developing an oral form of PTH-1-34.
Unigene also reported that it is developing an oral form of sCT.
Both candidates are in early stage clinical testing.
Novartis currently offers a nasal dosage form of sCT,
MIACALCIN®.
Other companies are currently developing pulmonary forms of
PTH-1-34. Other osteoporosis therapies include estrogen
replacement therapy, selective estrogen receptor modulators,
bisphosphonates and several new biologics that are under
development.
Oral
Osteoarthritis Competition
There has been no cure for osteoarthritis, as cartilage has not
been induced to regenerate. Current treatment is with NSAIDs,
local injections of glucocorticoid or hyaluronan, and in severe
cases, with joint replacement surgery. Future potential
treatments might include Autologous Chondrocyte Implantation and
cartilage regeneration.
If Novartis succeeds in developing its oral treatment for
osteoarthritis, we believe it could face competition from
existing and potentially future products and treatment regimens
under development.
Oral
Diabetes Competition Type 2 Diabetes
In diabetes, there are a number of unmet needs which amplify the
need for further product development in the area. There are
three main areas of drug therapy, oral anti-diabetes, insulin,
and injectable in which companies are attempting to develop
innovative products for the treatment of patients.
The need for new medicines due to unmet treatment needs recently
resulted in two new products; Amylins Byetta and Symlin.
These products initially performed exceedingly well in the
market place. However, due to pancreatitis associated with
Byetta, the trajectory for Amylins franchise has leveled
off as of the third quarter 2008.
There are four leading classes for new product development in
the area of diabetes. All four seek to take advantage of the
potential to improve upon currently available products:
1. GLP-1 Agonists
2. Pulmonary Insulin
20
3. DPP-IV Inhibitors
4. PPAR modulators.
The objective of our collaboration with Novo Nordisk is to
develop an orally available GLP-1 agonist for the treatment of
Type 2 diabetes and potentially obesity. A product with the
benefits of glucose control, promotion of weight loss, low risk
of hypoglycemia, and other benefits is expected to significantly
improve therapeutic options and can be expected to perform as
well as or better than the existing competition.
Oral
Vitamin B12 Competition
Emispheres potential competition in the Vitamin B12 market
will depend on the direction the company takes in the
development and commercialization of the product. In the event
that Emisphere pursues the nutritional supplements market,
competition would include a number of companies selling generic
Vitamin B12 in a variety of dosage strengths and methods of
delivery (e.g., oral, transdermal, nasal, sublingual) many of
which have substantial distribution and marketing capabilities
that exceed and will likely continue to exceed our own. In
addition, our competition is likely to include many sellers,
distributors, and others who are in the business of marketing,
selling, and promoting multiple vitamins, vitamin-mineral, and
specialized vitamin combinations. Many of these competitors are
engaged in low cost, high volume operations that could provide
substantial market barriers or other obstacles for a higher
cost, potentially superior product that has no prior market
history.
If Emisphere pursues the Vitamin B12 medical food market, the
Company would need to successfully demonstrate to physicians,
nurse-practitioners and payors that an oral dose would be safe,
efficacious, readily accessible and improve compliance. These
factors will likely require the Company to engage in a
substantial educational and promotional product launch and a
marketing outreach initiative, the time, cost, and outcome of
which are uncertain.
Competition
Summary
Although we believe that our oral formulations, if successful,
will likely compete with well established injectable versions of
the same drugs, we believe that we will enjoy a competitive
advantage because physicians and patients prefer orally
delivered forms of products over injectable forms. Oral forms of
products enable improved compliance, and for many programs, the
oral form of products enable improved therapeutic regimens.
Government
Regulation
Our operations and product candidates under development are
subject to extensive regulation by the FDA, other governmental
authorities in the U.S. and governmental authorities in
other countries.
The duration of the governmental approval process for marketing
new pharmaceutical substances, from the commencement of
pre-clinical testing to receipt of governmental approval for
marketing a new product, varies with the nature of the product
and with the country in which such approval is sought. The
approval process for new chemical entities could take eight to
ten years or more. The process for reformulations of existing
drugs is typically shorter, although a combination of an
existing drug with a currently unapproved carrier could require
extensive testing. In either case, the procedures required to
obtain governmental approval to market new drug products will be
costly and time-consuming to us, requiring rigorous testing of
the new drug product. Even after such time and effort,
regulatory approval may not be obtained for our products.
The steps required before we can market or ship a new human
pharmaceutical product commercially in the U.S. include
pre-clinical testing, the filing of an Investigational New Drug
Application (IND), the conduct of clinical trials
and the filing with the FDA of either a New Drug Application
(NDA) for drugs or a Biologic License Application
(BLA) for biologics.
In order to conduct the clinical investigations necessary to
obtain regulatory approval of marketing of new drugs in the
U.S., we must file an IND with the FDA to permit the shipment
and use of the drug for
21
investigational purposes. The IND sets forth, in part, the
results of pre-clinical (laboratory and animal) toxicology
testing and the applicants initial Phase I plans for
clinical (human) testing. Unless notified that testing may not
begin, the clinical testing may commence 30 days after
filing an IND.
Under FDA regulations, the clinical testing program required for
marketing approval of a new drug typically involves three
clinical phases. In Phase I, safety studies are generally
conducted on normal, healthy human volunteers to determine the
maximum dosages and side effects associated with increasing
doses of the substance being tested. Phase II studies are
conducted on small groups of patients afflicted with a specific
disease to gain preliminary evidence of efficacy, including the
range of effective doses, and to determine common short-term
side effects and risks associated with the substance being
tested. Phase III involves large-scale trials conducted on
disease-afflicted patients to provide statistically significant
evidence of efficacy and safety and to provide an adequate basis
for product labeling. Frequent reports are required in each
phase and if unwarranted hazards to patients are found, the FDA
may request modification or discontinuance of clinical testing
until further studies have been conducted. Phase IV testing
is sometimes conducted, either to meet FDA requirements for
additional information as a condition of approval. Our drug
product candidates are and will be subjected to each step of
this lengthy process from conception to market and many of those
candidates are still in the early phases of testing.
Once clinical testing has been completed pursuant to an IND, the
applicant files an NDA or BLA with the FDA seeking approval for
marketing the drug product. The FDA reviews the NDA or BLA to
determine whether the drug is safe and effective, and adequately
labeled, and whether the applicant can demonstrate proper and
consistent manufacture of the drug. The time required for
initial FDA action on an NDA or BLA is set on the basis of user
fee goals; for most NDA or BLAs the action date is
10 months from receipt of the NDA or BLA at the FDA. The
initial FDA action at the end of the review period may be
approval or a request for additional information that will be
needed for approval depending on the characteristics of the drug
and whether the FDA has concerns with the evidence submitted.
Once our product candidates reach this stage, we will be
subjected to these additional costs of time and money.
The FDA has different regulations and processes governing and
regulating food products, including vitamin supplements and
nutraceuticals. These products are variously referred to as
dietary supplements, food additives,
dietary ingredients, medical foods, and,
most broadly, food. These foods products do not
require the IND, NDA or BLA process outlined above.
The facilities of each company involved in the commercial
manufacturing, processing, testing, control and labeling of
pharmaceutical products must be registered with and approved by
the FDA. Continued registration requires compliance with GMP
regulations and the FDA conducts periodic establishment
inspections to confirm continued compliance with its
regulations. We are subject to various federal, state and local
laws, regulations and recommendations relating to such matters
as laboratory and manufacturing practices and the use, handling
and disposal of hazardous or potentially hazardous substances
used in connection with our research and development work.
While we do not currently manufacture any commercial products
ourselves, if we did, we would bear additional cost of FDA
compliance.
Employees
As of December 31, 2010, we had 16 employees, 8 of
whom are engaged in scientific research and technical functions
and 8 of whom are performing accounting, information technology,
engineering, facilities maintenance, legal and regulatory and
administrative functions. Of the 8 scientific employees, 4 hold
Ph.D. and/or
D.V.M. degrees. We believe our relations with our employees are
good.
Available
Information
Emisphere files annual, quarterly, and current reports, proxy
statements, and other documents with the Securities and Exchange
Commission, (the SEC) under the Securities Exchange
Act of 1934 (the Exchange Act). The public may read
and copy any materials that we file with the SEC at the
SECs Public Reference
22
Room at 100 F Street, NE, Washington, D.C. 20549.
The public may obtain information on the operation of the Public
Reference Room by calling the SEC at
1-800-SEC-0330.
Also, the SEC maintains an internet website that contains
reports, proxy and information statements, and other information
regarding issuers, including Emisphere, that file electronically
with the SEC. The public can obtain any documents that Emisphere
files with the SEC at www.sec.gov.
We also make available free of charge on or through our internet
website (www.emisphere.com) our Annual Report on
Form 10-K,
Quarterly Reports on
Form 10-Q,
Current Reports on
Form 8-K,
Section 16 filings, and, if applicable, amendments to those
reports filed or furnished pursuant to Section 13(a) or
Section 16 of the Exchange Act as soon as reasonably
practicable after we or the reporting person electronically
files such material with, or furnishes it to, the SEC. Our
internet website and the information contained therein or
connected thereto are not intended to be incorporated into the
Annual Report or this
Form 10-K.
Our Board of Directors has adopted a Code of Business Conduct
and Ethics which is posted on our website at
http://ir.emisphere.com/documentdisplay.cfm?DocumentID=4947.
From time to time, information provided by us, statements made
by our employees or information included in our filings with the
Securities and Exchange Commission (including this Report) may
contain statements that are not historical facts, so-called
forward-looking statements, which involve risks and
uncertainties. Such forward-looking statements are made pursuant
to the safe harbor provisions of Section 21E of the
Securities Exchange Act of 1934, as amended. In some cases you
can identify forward-looking statements by terminology such as
may, should, could,
will, expect, intend,
plans, predict, anticipate,
estimate, continue, believe
or the negative of these terms or other similar words. These
statements discuss future expectations, contain projections of
results of operations or of financial condition or state other
forward-looking information. When considering forward-looking
statements, you should keep in mind the risk factors and other
cautionary statements in this Report.
Our actual future results may differ significantly from those
stated in any forward-looking statements. Factors that may cause
such differences include, but are not limited to, the factors
discussed below. Each of these factors, and others, are
discussed from time to time in our filings with the Securities
and Exchange Commission.
Our operating results may fluctuate because of a number of
factors, many of which are beyond our control. If our operating
results are below the expectations of public market analysts or
investors, then the market price of our common stock could
decline. Some of the factors that affect our quarterly and
annual results, but which are difficult to control or predict,
are:
We
have a history of operating losses and we may never achieve
profitability. If we continue to incur losses or we fail to
raise additional capital or receive substantial cash inflows
from our partners by June 2011, we may be forced to cease
operations.
As of December 31, 2010, we had approximately
$5.6 million in cash and restricted cash, approximately
$20.6 million in working capital deficiency, a
stockholders deficit of approximately $82.5 million
and an accumulated deficit of approximately $480.9 million.
Our operating and net loss for the year ended December 31,
2010 was approximately $11.5 million and
$56.9 million, respectively. Since our inception in 1986,
we have generated significant losses from operations. We
anticipate that we will continue to generate significant losses
from operations for the foreseeable future, and that our
business will require substantial additional investment that we
have not yet secured. These conditions raise substantial doubt
about our ability to continue as a going concern. The audit
reports prepared by our independent registered public accounting
firms relating to our financial statements for the years ended
December 31, 2008, 2009 and 2010, respectively, included an
explanatory paragraph expressing substantial doubt about our
ability to continue as a going concern.
23
We anticipate that our existing capital resources will enable us
to continue operations through approximately June 2011, or
earlier if unforeseen events or circumstances arise that
negatively affect our liquidity. If we fail to raise additional
capital or obtain substantial cash inflows from existing
partners prior to June 2011, we will be forced to cease
operations.
While our plan is to raise capital when needed
and/or to
pursue product partnering opportunities, we cannot be sure how
much we will need to spend in order to develop, market, and
manufacture new products and technologies in the future. We
expect to continue to spend substantial amounts on research and
development, including amounts spent on conducting clinical
trials for our product candidates. Further, we will not have
sufficient resources to develop fully any new products or
technologies unless we are able to raise substantial additional
financing or to secure funds from new or existing partners. We
cannot assure you that financing will be available when needed,
or on favorable terms or at all. The current economic
environment combined with a number of other factors pose
additional challenges to the Company in securing adequate
financing under acceptable terms. If additional capital is
raised through the sale of equity or convertible debt
securities, the issuance of such securities would result in
dilution to our existing stockholders. Additionally, these
conditions may increase the costs to raise capital. Our failure
to raise capital when needed would adversely affect our
business, financial condition, and results of operations, and
could force us to reduce or discontinue operations.
We may
not be able to meet the covenants detailed in the Convertible
Notes with MHR Institutional Partners IIA LP, which could result
in an increase in the interest rate on the Convertible Notes
and/or accelerated maturity of the Convertible Notes, which we
would not be able to satisfy.
On September 26, 2005, we executed a Senior Secured Loan
Agreement (the Loan Agreement) with MHR. The Loan
Agreement, as amended, provides for a seven year,
$15 million secured loan from MHR to us at an interest rate
of 11% (the Loan). Under the Loan Agreement, MHR
requested, and on May 16, 2006 we effected, the exchange of
the Loan for 11% senior secured convertible notes (the
MHR Convertible Notes) with substantially the same
terms as the Loan Agreement, except that the MHR Convertible
Notes are convertible, at the sole discretion of MHR or any
assignee thereof, into shares of our common stock at a price per
share of $3.78. Interest will be payable in the form of
additional MHR Convertible Notes rather than in cash. The MHR
Convertible Notes are secured by a first priority lien in favor
of MHR on substantially all of our assets.
The MHR Convertible Notes provide for certain events of default
including failure to perfect liens in favor of MHR created by
the transaction, failure to observe any covenant or agreement,
failure to maintain the listing and trading of our common stock,
sale of a substantial portion of our assets, or merger with
another entity without the prior consent of MHR, or any
governmental action renders us unable to honor or perform our
obligations under the MHR Convertible Notes or results in a
material adverse effect on our operations among other things. If
an event of default occurs, the MHR Convertible Notes provide
for the immediate repayment of the Notes and certain additional
amounts described above and as set forth in the MHR Convertible
Notes. At such time, we may not be able to make the required
payment, and if we are unable to pay the amount due under the
MHR Convertible Notes, the resulting default would enable MHR to
foreclose on all of our assets. Any of the foregoing events
would have a material adverse effect on our business and on the
value of our stockholders investments in our common stock.
We currently have a waiver from MHR for failure to perfect liens
on certain intellectual property rights through March 19,
2012.
Our
stock was de-listed from NASDAQ.
Our common stock was suspended from trading on the NASDAQ
Capital Market effective at the open of business on June 9,
2009, and NASDAQ delisted the Companys securities
thereafter. The delisting resulted from the Companys
non-compliance with the minimum market value of listed
securities requirement for continued listing on The NASDAQ
Capital Market pursuant to NASDAQ Marketplace
Rule 4310(c)(3)(B). Simultaneously, the Companys
securities began trading on the
Over-the-Counter
Bulletin Board (the OTCBB), an electronic
quotation service maintained by the Financial Industry
Regulatory Authority,
24
effective with the open of business on June 9, 2009. The
Companys trading symbol has remained EMIS; however, it is
our understanding that, for certain stock quote publication
websites, investors may be required to key EMIS.OB to obtain
quotes.
Because our stock is traded on the OTCBB, selling our common
stock could be more difficult because smaller quantities of
shares would likely be bought and sold, transactions could be
delayed, and security analysts coverage of us may be
reduced or harder to obtain. In addition, because our common
stock was de-listed from the NASDAQ Capital Market,
broker-dealers have certain regulatory burdens imposed upon
them, which may discourage broker-dealers from effecting
transactions in our common stock, further limiting the liquidity
thereof. These factors could result in lower prices and larger
spreads in the bid and ask prices for shares of our common stock
and/or limit
an investors ability to execute a transaction.
The delisting from the NASDAQ Capital Market or future declines
in our stock price could also greatly impair our ability to
raise additional necessary capital through equity or debt
financing, and could significantly increase the ownership
dilution to stockholders caused by our issuing equity in
financing or other transactions.
Our
business will suffer if we fail or are delayed in developing and
commercializing an improved oral form of Vitamin
B12.
We are focusing substantial resources on the development of an
oral dosage form of Vitamin B12 that will demonstrate improved
bioavailability compared with current B12 tablets. During
November 2009, the Company launched its first commercially
available product, oral
Eligen®
B12 (100 mcg), which had been specifically developed to help
improve Vitamin B12 absorption and bioavailability with a
patented formulation. During the third quarter 2010, we
terminated our distributor agreement for the marketing,
distribution and sale of oral
Eligen®
B12 (100mcg.) with Quality Vitamins and Supplements, Inc. to
allow us to focus on the development of a higher dose, oral
formulation of
Eligen®
B12 (1000 mcg) to be offered for B12 deficient patients. Our
inability or delay in developing or commercializing the B12
product candidate could have a significant material adverse
effect on our business.
To commercialize this higher dose product candidate, we will be
required to complete certain clinical studies, develop a market
introduction plan, and possibly obtain financing to support our
commercialization efforts, among other things. We cannot assure
you that we will succeed in these efforts as these involve
activities (or portions of activities) that we have not
previously completed. In addition, if we succeed in these
activities, Vitamin B12 is available at reasonably low prices
both in injections and tablet forms (as well as other forms)
through a variety of distributors, sellers, and other sources.
We have no current commercial capabilities. Therefore, we would
be entering a highly competitive market with an untested,
newly-established commercial capability. This outline of risks
involved in the development and commercialization of B12 is not
exhaustive, but illustrative. For example, it does not include
additional competitive, intellectual property, commercial,
product liability, and commercial risks involved in a launch of
the B12 product candidate outside the U.S. or certain of
such risks in the U.S.
We are
highly dependent upon collaborative partners to develop and
commercialize compounds using our delivery agents.
A key part of our strategy is to form collaborations with
pharmaceutical companies that will assist us in developing,
testing, obtaining government approval for and commercializing
oral forms of therapeutic macromolecules using the
Eligen®
Technology. We have a collaborative agreement for candidates in
clinical development with Novartis, Novo Nordisk and Genta.
We negotiate specific ownership rights with respect to the
intellectual property developed as a result of the collaboration
with each partner. While ownership rights vary from program to
program, in general we retain ownership rights to developments
relating to our carrier and the collaborator retains rights
related to the drug product developed.
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Despite our existing agreements, we cannot make any assurances
that:
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we will be able to enter into additional collaborative
arrangements to develop products utilizing our drug delivery
technology;
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any existing or future collaborative arrangements will be
sustainable or successful;
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the product candidates in collaborative arrangements will be
further developed by partners in a timely fashion;
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any collaborative partner will not infringe upon our
intellectual property position in violation of the terms of the
collaboration contract; or
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milestones in collaborative agreements will be met and milestone
payments will be received.
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If we are unable to obtain development assistance and funds from
other pharmaceutical companies to fund a portion of our product
development costs and to commercialize our product candidates,
we may be unable to issue equity to allow us to raise sufficient
capital to fund clinical development of our product candidates.
Lack of funding would cause us to delay, curtail, or stop
clinical development of one or more of our projects. The
determination of the specific project to curtail would depend
upon the relative future economic value to us of each program.
Our
collaborative partners control the clinical development of the
drug candidates and may terminate their efforts at
will.
Novartis controls the clinical development of oral salmon
calcitonin, PTH, and rhGH. Novo Nordisk controls the clinical
development of oral GLP-1 analogs. Genta controls the clinical
development of oral gallium. Novartis, Novo Nordisk and Genta
control the decision-making for the design and timing of their
clinical studies.
Moreover, the agreements with Novartis, Novo Nordisk and Genta
provide that they may terminate their programs at will for any
reason and without any financial penalty or requirement to fund
any further clinical studies. We cannot make any assurance that
Novartis, Novo Nordisk or Genta will continue to advance the
clinical development of the drug candidates subject to
collaboration.
Our
collaborative partners are free to develop competing
products.
Aside from provisions preventing the unauthorized use of our
intellectual property by our collaborative partners, there is
nothing in our collaborative agreements that prevent our
partners from developing competing products. If one of our
partners were to develop a competing product, our collaboration
could be substantially jeopardized.
Our
product candidates are in various stages of development, and we
cannot be certain that any will be suitable for commercial
purposes.
To be profitable, we must successfully research, develop, obtain
regulatory approval for, manufacture, introduce, market, and
distribute our products under development, or secure a partner
to provide financial and other assistance with these steps. The
time necessary to achieve these goals for any individual
pharmaceutical product is long and can be uncertain. Before we
or a potential partner can sell any of the pharmaceutical
products currently under development, pre-clinical (animal)
studies and clinical (human) trials must demonstrate that the
product is safe and effective for human use for each targeted
indication. We have never successfully commercialized a drug or
a nonprescription candidate and we cannot be certain that we or
our current or future partners will be able to begin, or
continue, planned clinical trials for our product candidates, or
if we are able, that the product candidates will prove to be
safe and will produce their intended effects.
Even if safe and effective, the size of the solid dosage form,
taste, and frequency of dosage may impede their acceptance by
patients.
26
A number of companies in the drug delivery, biotechnology, and
pharmaceutical industries have suffered significant setbacks in
clinical trials, even after showing promising results in earlier
studies or trials. Only a small number of research and
development programs ultimately result in commercially
successful drugs. Favorable results in any pre-clinical study or
early clinical trial do not imply that favorable results will
ultimately be obtained in future clinical trials. We cannot make
any assurance that results of limited animal and human studies
are indicative of results that would be achieved in future
animal studies or human clinical studies, all or some of which
will be required in order to have our product candidates obtain
regulatory approval. Similarly, we cannot assure you that any of
our product candidates will be approved by the FDA. Even if
clinical trials or other studies demonstrate safety and
effectiveness of any of our product candidates for a specific
disease or condition and the necessary regulatory approvals are
obtained, the commercial success of any of our product
candidates will depend upon their acceptance by patients, the
medical community, and third-party payers and on our
partners ability to successfully manufacture and
commercialize our product candidates.
Our
future business success depends heavily upon regulatory
approvals, which can be difficult and expensive to
obtain.
Our pre-clinical studies and clinical trials of our prescription
drug and biologic product candidates, as well as the
manufacturing and marketing of our product candidates, are
subject to extensive, costly and rigorous regulation by
governmental authorities in the U.S. and other countries.
The process of obtaining required approvals from the FDA and
other regulatory authorities often takes many years, is
expensive, and can vary significantly based on the type,
complexity, and novelty of the product candidates. We cannot
assure you that we, either independently or in collaboration
with others, will meet the applicable regulatory criteria in
order to receive the required approvals for manufacturing and
marketing. Delays in obtaining U.S. or foreign approvals
for our self-developed projects could result in substantial
additional costs to us, and, therefore, could adversely affect
our ability to compete with other companies. Additionally,
delays in obtaining regulatory approvals encountered by others
with whom we collaborate also could adversely affect our
business and prospects. Even if regulatory approval of a product
is obtained, the approval may place limitations on the intended
uses of the product, and may restrict the way in which we or our
partner may market the product.
The regulatory approval process for our prescription drug
product candidates presents several risks to us:
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In general, pre-clinical tests and clinical trials can take many
years, and require the expenditure of substantial resources. The
data obtained from these tests and trials can be susceptible to
varying interpretation that could delay, limit or prevent
regulatory approval
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Delays or rejections may be encountered during any stage of the
regulatory process based upon the failure of the clinical or
other data to demonstrate compliance with, or upon the failure
of the product to meet, a regulatory agencys requirements
for safety, efficacy, and quality or, in the case of a product
seeking an orphan drug indication, because another designee
received approval first
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Requirements for approval may become more stringent due to
changes in regulatory agency policy or the adoption of new
regulations or guidelines
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New guidelines can have an effect on the regulatory decisions
made in previous years
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The scope of any regulatory approval, when obtained, may
significantly limit the indicated uses for which a product may
be marketed and may impose significant limitations in the nature
of warnings, precautions, and contraindications that could
materially affect the profitability of the drug
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Approved drugs, as well as their manufacturers, are subject to
continuing and ongoing review, and discovery of problems with
these products or the failure to adhere to manufacturing or
quality control requirements may result in restrictions on their
manufacture, sale or use or in their withdrawal from the market
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Regulatory authorities and agencies may promulgate additional
regulations restricting the sale of our existing and proposed
products
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Once a product receives marketing approval, the FDA may not
permit us to market that product for broader or different
applications, or may not grant us clearance with respect to
separate product applications that represent extensions of our
basic technology. In addition, the FDA may withdraw or modify
existing clearances in a significant manner or promulgate
additional regulations restricting the sale of our present or
proposed products
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Additionally, we face the risk that our competitors may gain FDA
approval for a product before us. Having a competitor reach the
market before us would impede the future commercial success for
our competing product because we believe that the FDA uses
heightened standards of approval for products once approval has
been granted to a competing product in a particular product
area. We believe that this standard generally limits new
approvals to only those products that meet or exceed the
standards set by the previously approved product.
The regulatory approval process for nonprescription product
candidates will likely vary by the nature of therapeutic
molecule being delivered.
Our
business will suffer if we cannot adequately protect our patent
and proprietary rights.
Although we have patents for some of our product candidates and
have applied for additional patents, there can be no assurance
that patents applied for will be granted, that patents granted
to or acquired by us now or in the future will be valid and
enforceable and provide us with meaningful protection from
competition, or that we will possess the financial resources
necessary to enforce any of our patents. Also, we cannot be
certain that any products that we (or a licensee) develop will
not infringe upon any patent or other intellectual property
right of a third party.
We also rely upon trade secrets, know-how, and continuing
technological advances to develop and maintain our competitive
position. We maintain a policy of requiring employees,
scientific advisors, consultants, and collaborators to execute
confidentiality and invention assignment agreements upon
commencement of a relationship with us. We cannot assure you
that these agreements will provide meaningful protection for our
trade secrets in the event of unauthorized use or disclosure of
such information.
Part of our strategy involves collaborative arrangements with
other pharmaceutical companies for the development of new
formulations of drugs developed by others and, ultimately, the
receipt of royalties on sales of the new formulations of those
drugs. These drugs are generally the property of the
pharmaceutical companies and may be the subject of patents or
patent applications and other rights of protection owned by the
pharmaceutical companies. To the extent those patents or other
forms of rights expire, become invalid or otherwise ineffective,
or to the extent those drugs are covered by patents or other
forms of protection owned by third parties, sales of those drugs
by the collaborating pharmaceutical company may be restricted,
limited, enjoined, or may cease. Accordingly, the potential for
royalty revenues to us may be adversely affected.
We may
be at risk of having to obtain a license from third parties
making proprietary improvements to our technology.
There is a possibility that third parties may make improvements
or innovations to our technology in a more expeditious manner
than we do. Although we are not aware of any such circumstance
related to our product portfolio, should such circumstances
arise, we may need to obtain a license from such third party to
obtain the benefit of the improvement or innovation.
Royalties payable under such a license would reduce our
share of total revenue. Such a license may not be available to
us at all or on commercially reasonable terms. Although we
currently do not know of any circumstances related to our
product portfolio which would lead us to believe that a third
party has developed any improvements or innovation with respect
to our technology, we cannot assure you that such circumstances
will not arise in the future. We cannot reasonably determine the
cost to us of the effect of being unable to obtain any such
license.
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We are
dependent on third parties to manufacture and test our
products.
Currently, we have no manufacturing facilities for production of
our carriers or any therapeutic compounds under consideration as
products. We have no facilities for clinical testing. The
success of our self-developed programs is dependent upon
securing manufacturing capabilities and contracting with
clinical service and other service providers.
The availability of manufacturers is limited by both the
capacity of such manufacturers and their regulatory compliance.
Among the conditions for NDA approval is the requirement that
the prospective manufacturers quality control and
manufacturing procedures continually conform with the FDAs
current GMP (GMP are regulations established by the FDA that
govern the manufacture, processing, packing, storage and testing
of drugs intended for human use). In complying with GMP,
manufacturers must devote extensive time, money, and effort in
the area of production and quality control and quality assurance
to maintain full technical compliance. Manufacturing facilities
and company records are subject to periodic inspections by the
FDA to ensure compliance. If a manufacturing facility is not in
substantial compliance with these requirements, regulatory
enforcement action may be taken by the FDA, which may include
seeking an injunction against shipment of products from the
facility and recall of products previously shipped from the
facility. Such actions could severely delay our ability to
obtain product from that particular source.
The success of our clinical trials and our partnerships is
dependent on the proposed or current partners capacity and
ability to adequately manufacture drug products to meet the
proposed demand of each respective market. Any significant delay
in obtaining a supply source (which could result from, for
example, an FDA determination that such manufacturer does not
comply with current GMP) could harm our potential for success.
Additionally, if a current manufacturer were to lose its ability
to meet our supply demands during a clinical trial, the trial
may be delayed or may even need to be abandoned.
We may
face product liability claims related to participation in
clinical trials or future products.
We have product liability insurance with a policy limit of
$5.0 million per occurrence and in the aggregate. The
testing, manufacture, and marketing of products for humans
utilizing our drug delivery technology may expose us to
potential product liability and other claims. These may be
claims directly by consumers or by pharmaceutical companies or
others selling our future products. We seek to structure
development programs with pharmaceutical companies that would
complete the development, manufacturing and marketing of the
finished product in a manner that would protect us from such
liability, but the indemnity undertakings for product liability
claims that we secure from the pharmaceutical companies may
prove to be insufficient.
We
face rapid technological change and intense
competition.
Our success depends, in part, upon maintaining a competitive
position in the development of products and technologies in an
evolving field in which developments are expected to continue at
a rapid pace. We compete with other drug delivery, biotechnology
and pharmaceutical companies, research organizations, individual
scientists, and non-profit organizations engaged in the
development of alternative drug delivery technologies or new
drug research and testing, as well as with entities developing
new drugs that may be orally active. Many of these competitors
have greater research and development capabilities, experience,
and marketing, financial, and managerial resources than we have,
and, therefore, represent significant competition.
Our products, when developed and marketed, may compete with
existing parenteral or other versions of the same drug, some of
which are well established in the marketplace and manufactured
by formidable competitors, as well as other existing drugs. For
example, our salmon calcitonin product candidate, if developed
and marketed, would compete with a wide array of existing
osteoporosis therapies, including a nasal dosage form of salmon
calcitonin, estrogen replacement therapy, selective estrogen
receptor modulators, bisphosphonates, and other compounds in
development.
Our competitors may succeed in developing competing technologies
or obtaining government approval for products before we do.
Developments by others may render our product candidates, or the
therapeutic
29
macromolecules used in combination with our product candidates,
noncompetitive or obsolete. At least one competitor has notified
the FDA that it is developing a competing formulation of salmon
calcitonin. If our products are marketed, we cannot assure you
that they will be preferred to existing drugs or that they will
be preferred to or available before other products in
development.
If a competitor announces a successful clinical study involving
a product that may be competitive with one of our product
candidates or an approval by a regulatory agency of the
marketing of a competitive product, such announcement may have a
material adverse effect on our operations or future prospects
resulting from reduced sales of future products that we may wish
to bring to market or from an adverse impact on the price of our
common stock or our ability to obtain regulatory approval for
our product candidates.
We are
dependent on our key personnel and if we cannot recruit and
retain leaders in our research, development, manufacturing, and
commercial organizations, our business will be
harmed.
We are dependent on our executive officers. The loss of one or
more members of our executive officers or key employees could
have an adverse effect on our business, financial condition and
results of operations, given their specific knowledge related to
our proprietary technology and personal relationships with our
pharmaceutical company partners. If we are not able to retain
our executive officers, our business may suffer. We do not
maintain key-man life insurance policies for any of
our executive officers.
During February 2011, Michael V. Novinski resigned as a director
of the Company and from his position as President and Chief
Executive Officer of the Company. A comprehensive search is
underway to identify our next Chief Executive Officer. However,
we cannot assure you that we will be able to find a qualified
permanent replacement for Mr. Novinski. In addition, the
loss of one or more of our other executive officers or key
employees or a delay or inability to hire a new Chief Executive
Officer could seriously harm our business.
There is intense competition in the biotechnology industry for
qualified scientists and managerial personnel in the
development, manufacture, and commercialization of drugs. We may
not be able to continue to attract and retain the qualified
personnel necessary for developing our business. Additionally,
because of the knowledge and experience of our scientific
personnel and their specific knowledge with respect to our drug
carriers the continued development of our product candidates
could be adversely affected by the loss of any significant
number of such personnel.
Provisions
of our corporate charter documents, Delaware law, and our
stockholder rights plan may dissuade potential acquirers,
prevent the replacement or removal of our current management and
may thereby affect the price of our common stock.
Our Board of Directors has the authority to issue up to
1,000,000 shares of preferred stock and to determine the
rights, preferences and privileges of those shares without any
further vote or action by our stockholders. Of these
1,000,000 shares, 200,000 are currently designated
Series A Junior Participating Cumulative Preferred Stock
(A Preferred Stock) in connection with our
stockholder rights plan, and the remaining 800,000 shares
remain available for future issuance. Rights of holders of
common stock may be adversely affected by the rights of the
holders of any preferred stock that may be issued in the future.
We also have a stockholder rights plan, commonly referred to as
a poison pill, in which A Preferred Stock purchase
rights (the Rights) have been granted at the rate of
one one-hundredth of a share of A Preferred Stock at an exercise
price of $80 for each share of our common stock. The Rights are
not exercisable or transferable apart from the common stock,
until the earlier of (i) ten days following a public
announcement that a person or group of affiliated or associated
persons have acquired beneficial ownership of 20% or more of our
outstanding common stock or (ii) ten business days (or such
later date, as defined) following the commencement of, or
announcement of an intention to make a tender offer or exchange
offer, the consummation of which would result in the beneficial
ownership by a person, or group, of 20% or more of our
outstanding common stock. If we enter into consolidation,
merger, or other business combinations, as defined, each Right
would entitle the holder upon exercise to receive, in lieu of
shares of A Preferred Stock, a number of shares of common stock
of the acquiring company having a value of two times the
exercise price of the
30
Right, as defined. By potentially diluting the ownership of the
acquiring company, our rights plan may dissuade prospective
acquirors of our company. MHR is specifically excluded from the
provisions of the plan.
The holders of A Preferred Stock would be entitled to a
preferential cumulative quarterly dividend of the greater of
$1.00 per share or 100 times the per-share dividend declared on
our stock and are also entitled to a liquidation preference,
thereby hindering an acquirers ability to freely pay
dividends or to liquidate the company following an acquisition.
Each A Preferred Stock share will have 100 votes and will vote
together with the common shares, effectively preventing an
acquirer from removing existing management. The Rights contain
anti-dilutive provisions and are redeemable at our option,
subject to certain defined restrictions for $.01 per Right. The
Rights expire on April 7, 2016.
Provisions
of our corporate charter documents, Delaware law and financing
agreements may prevent the replacement or removal of our current
management and members of our Board of Directors and may thereby
affect the price of our common stock.
In connection with the MHR financing transaction, and after
approval by our Board of Directors, Dr. Mark H. Rachesky
was appointed to the Board of Directors by MHR (the MHR
Nominee) and Dr. Michael Weiser was appointed to the
Board of Directors by both the majority of our Board of
Directors and MHR (the Mutual Director), as
contemplated by our bylaws. Our certificate of incorporation
provides that the MHR Nominee and the Mutual Director may be
removed only by the affirmative vote of at least 85% of the
shares of common stock outstanding and entitled to vote at an
election of directors. Our certificate of incorporation also
provides that the MHR Nominee may be replaced only by an
individual designated by MHR unless the MHR Nominee has been
removed for cause, in which case the MHR Nominee may be replaced
only by an individual approved by both a majority of our Board
of Directors and MHR. Furthermore, the amendments to the bylaws
and the certificate of incorporation provide that the rights
granted to MHR by these amendments may not be amended or
repealed without the unanimous vote or unanimous written consent
of the Board of Directors or the affirmative vote of the holders
of at least 85% of the shares of Common Stock outstanding and
entitled to vote at the election of directors. The amendments to
the bylaws and the certificate of incorporation will remain in
effect as long as MHR holds at least 2% of the shares of fully
diluted Common Stock. The amendments to the bylaws and the
certificate of incorporation will have the effect of making it
more difficult for a third party to gain control of our Board of
Directors.
Additional provisions of our certificate of incorporation and
bylaws could have the effect of making it more difficult for a
third party to acquire a majority of our outstanding voting
common stock. These include provisions that classify our Board
of Directors, limit the ability of stockholders to take action
by written consent, call special meetings, remove a director for
cause, amend the bylaws or approve a merger with another
company. We are subject to the provisions of Section 203 of
the Delaware General Corporation Law which prohibits a
publicly-held Delaware corporation from engaging in a
business combination with an interested
stockholder for a period of three years after the date of
the transaction in which the person became an interested
stockholder, unless the business combination is approved in a
prescribed manner. For purposes of Section 203, a
business combination includes a merger, asset sale
or other transaction resulting in a financial benefit to the
interested stockholder, and an interested
stockholder is a person who, either alone or together with
affiliates and associates, owns (or within the past three years,
did own) 15% or more of the corporations voting stock.
Our
stock price has been and may continue to be
volatile.
The trading price for our common stock has been and is likely to
continue to be highly volatile. The market prices for securities
of drug delivery, biotechnology and pharmaceutical companies
have historically been highly volatile.
Factors that could adversely affect our stock price include:
|
|
|
|
|
fluctuations in our operating results; announcements of
partnerships or technological collaborations;
|
|
|
|
innovations or new products by us or our competitors;
|
|
|
|
governmental regulation;
|
31
|
|
|
|
|
developments in patent or other proprietary rights;
|
|
|
|
public concern as to the safety of drugs developed by us or
others;
|
|
|
|
the results of pre-clinical testing and clinical studies or
trials by us, our partners or our competitors;
|
|
|
|
litigation;
|
|
|
|
general stock market and economic conditions;
|
|
|
|
number of shares available for trading (float); and
|
|
|
|
inclusion in or dropping from stock indexes.
|
As of December 31, 2010, our 52-week high and low closing
market price for our common stock was $3.75 and $0.77,
respectively.
Future
sales of common stock or warrants, or the prospect of future
sales, may depress our stock price.
Sales of a substantial number of shares of common stock or
warrants, or the perception that sales could occur, could
adversely affect the market price of our common stock.
Additionally, as of December 31, 2010, there were
outstanding options to purchase up to 2,367,037 shares of
our common stock that are currently exercisable, and additional
outstanding options to purchase up to 798,829 shares of
common stock that are exercisable over the next several years.
As of December 31, 2010, the MHR Convertible Notes were
convertible into 6,675,512 shares of our common stock. As
of December 31, 2010, there were outstanding warrants to
purchase 11,832,826 shares of our stock. The holders of
these options have an opportunity to profit from a rise in the
market price of our common stock with a resulting dilution in
the interests of the other shareholders. The existence of these
options may adversely affect the terms on which we may be able
to obtain additional financing. The weighted average exercise
price of issued and outstanding options is $3.51 and the
weighted average exercise price of warrants is $1.42 which
compares to the $2.41 market price at closing on
December 31, 2010.
|
|
ITEM 1B.
|
UNRESOLVED
STAFF COMMENTS
|
None.
We lease approximately 15,000 square feet of office space
at 240 Cedar Knolls Road, Suite 200, Cedar Knolls, New
Jersey for use as our corporate office. The lease for our
corporate office is set to expire on January 31, 2013.
At the beginning of 2009 we had leased approximately
80,000 square feet of office space at 765 Old Saw Mill
River Road, Tarrytown, NY for use as administrative offices and
laboratories. The lease for our administrative and laboratory
facilities had been set to expire on August 31, 2012.
However, on April 29, 2009, the Company entered into a
Lease Termination Agreement (the Lease Agreement)
with
BMR-Landmark
at Eastview, LLC, a Delaware limited liability company
(BMR) pursuant to which the Company and BMR
terminated the lease of space at 765 Old Saw Mill River Road in
Tarrytown, NY. Pursuant to the Lease Agreement, the lease was
terminated effective as of April 1, 2009. The Lease
Agreement provided that the Company make the following payments
to BMR: (a) $1 million, paid upon execution of the
Lease Agreement, (b) $0.5 million, paid six months
after the execution date of the Lease Agreement, and
(c) $0.75 million, payable twelve months after the
execution date of the Lease Agreement. Initial and six months
payments were made on schedule. The final payment was originally
due April 29, 2010. However, on March 17, 2010 the
Company and BMR agreed to amend the Lease Agreement (the
Lease Amendment). According to the Lease Amendment,
the final payment will be modified as follows: the Company will
pay Eight Hundred Thousand Dollars ($800,000), as follows:
(i) Two Hundred Thousand Dollars ($200,000) within five
(5) days after the Execution Date and (ii) One Hundred
Thousand Dollars ($100,000) on each of the following dates:
July 15, 2010, August 15, 2010, September 15,
2010, October 15, 2010, November 15, 2010, and
December 15, 2010. Through March 1, 2011, the Company
paid $600,000 of the principal plus $21,000 interest for late
payments in accordance with the terms of the termination
agreement.
32
|
|
ITEM 3.
|
LEGAL
PROCEEDINGS
|
In April 2005, the Company entered into an amended and restated
employment agreement with its then Chief Executive Officer,
Dr. Michael M. Goldberg, for services through July 31,
2007. On January 16, 2007, the Board of Directors
terminated Dr. Goldbergs services. On April 26,
2007, the Board of Directors held a special hearing at which it
determined that Dr. Goldbergs termination was for
cause. On March 22, 2007, Dr. Goldberg, through his
counsel, filed a demand for arbitration asserting that his
termination was without cause and seeking $1,048,000 plus
attorneys fees, interest, arbitration costs and other
relief alleged to be owed to him in connection with his
employment agreement with the Company. During the arbitration,
Dr. Goldberg sought a total damage amount of at least
$9,223,646 plus interest. On February 11, 2010, the
arbitrator issued the final award in favor of Dr. Goldberg
for a total amount of approximately $2,333,115 plus interest and
fees as full and final payment for all claims, defenses,
counterclaims, and related matters. The Company opposed
Dr. Goldbergs petition to confirm the arbitration
award. On July 12, 2010 the award was confirmed by the
court. As of August 10, 2010, the Company adjusted its
estimate of costs to settle this matter to approximately
$2.6 million to account for potential additional interest
costs on the settlement amount and additional legal fees. On
September 23, 2010, the Company paid approximately
$2.6 million as the full and final settlement of this
matter.
PART II
|
|
ITEM 5.
|
MARKET
FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Nasdaq
Listing
The Companys securities were suspended from trading on the
NASDAQ Capital Market effective at the open of business on
Tuesday, June 9, 2009, and NASDAQ delisted the
Companys securities thereafter. The delisting resulted
from the Companys non-compliance with the minimum market
value of listed securities requirement for continued listing on
the NASDAQ Capital Market pursuant to NASDAQ Marketplace
Rule 4310(c)(3)(B. Simultaneously, the Companys
securities began trading on the OTCBB, an electronic quotation
service maintained by the Financial Industry Regulatory
Authority, effective with the open of business on Tuesday,
June 9, 2009. The Companys trading symbol has
remained EMIS; however, it is our understanding that, for
certain stock quote publication websites, investors may be
required to key EMIS.OB to obtain quotes.
The following table sets forth the range of high and low
intra-day
sale prices as reported by the NASDAQ Stock Market or the OTCBB,
electronic quotation service (post de-listing from the NASDAQ
Stock Market on June 9, 2009) for each period
indicated:
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
2009
|
|
|
|
|
|
|
|
|
First quarter
|
|
$
|
1.06
|
|
|
$
|
0.43
|
|
Second quarter
|
|
|
1.49
|
|
|
|
0.42
|
|
Third quarter
|
|
|
1.18
|
|
|
|
0.72
|
|
Fourth quarter
|
|
|
1.08
|
|
|
|
0.46
|
|
2010
|
|
|
|
|
|
|
|
|
First quarter
|
|
|
2.75
|
|
|
|
0.92
|
|
Second quarter
|
|
|
3.75
|
|
|
|
2.07
|
|
Third quarter
|
|
|
3.20
|
|
|
|
0.77
|
|
Fourth quarter
|
|
|
2.68
|
|
|
|
1.01
|
|
2011
|
|
|
|
|
|
|
|
|
First quarter (through March 25, 2011)
|
|
|
2.48
|
|
|
|
1.23
|
|
33
As of March 25, 2011 there were 221 stockholders of record,
including record owners holding shares on behalf of an
indeterminate number of beneficial owners, and
52,076,602 shares of common stock outstanding. The closing
price of our common stock on March 25, 2011 was $1.26.
We have never paid cash dividends and do not intend to pay cash
dividends in the foreseeable future. We intend to retain
earnings, if any, to finance the growth of our business.
Equity
Compensation Plan Information
The following table provides information as of December 31,
2010 about the common stock that may be issued upon the exercise
of options granted to employees, consultants or members of our
board of directors under all of our existing equity compensation
plans, including the 1991 Stock Option Plan, 1995 Stock Option
Plan, 2000 Stock Option Plan, the 2002 Broad Based Plan, the
2007 Stock Award and Incentive Plan, (collectively the
Plans), the Stock Incentive Plan for Outside
Directors, and the Directors Deferred Compensation Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
|
|
|
|
(c)
|
|
|
|
Number of
|
|
|
(b)
|
|
|
Number of Securities
|
|
|
|
Securities to be
|
|
|
Weighted
|
|
|
Remaining Available for
|
|
|
|
Issued Upon
|
|
|
Average
|
|
|
Future Issuance Under
|
|
|
|
Exercise of
|
|
|
Exercise Price
|
|
|
Equity Compensation Plans
|
|
|
|
Outstanding
|
|
|
of Outstanding
|
|
|
(Excluding Securities
|
|
Plan Category
|
|
Options
|
|
|
Options
|
|
|
Reflected in Column (a))
|
|
|
Equity Compensation Plans Approved by Security Holders
|
|
|
|
|
|
|
|
|
|
|
|
|
The Plans
|
|
|
3,055,866
|
|
|
$
|
3.29
|
|
|
|
1,432,148
|
|
Stock Incentive Plan for Outside Directors
|
|
|
100,000
|
|
|
|
10.24
|
|
|
|
|
|
Directors Deferred Compensation Plan
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation Plans not approved by Security
Holders(1)
|
|
|
10,000
|
|
|
|
3.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3,165,866
|
|
|
$
|
3.51
|
|
|
|
1,432,148
|
|
|
|
|
(1) |
|
Our Board of Directors has granted options which are currently
outstanding for a former consultant. The Board of Directors
determines the number and terms of each grant (option exercise
price, vesting and expiration date). These grants were made on
July 12, 2002 and July 14, 2003. |
34
Comparative
Stock Performance Graph
The graph below compares the cumulative total stockholder return
through December 31, 2010 on Emispheres common stock
with the cumulative total stockholder return of the NASDAQ
Composite Index, the NASDAQ Pharmaceutical Index, the RDG
MicroCap Pharmaceutical Index, the Dow Jones
U.S. Pharmaceuticals Total Stock Market Index, and SIC
Code: 2834 Pharmaceutical Preparations, assuming an
investment of $100 on December 31, 2005 in the
Companys common stock, and in the stocks comprising each
index (with all dividends reinvested).
COMPARISON
OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Emisphere Technologies, Inc.
|
|
|
* |
|
$100 invested on 12/31/05 in stock or index, including
reinvestment of dividends. |
|
|
|
Fiscal year ending December 31.
Copyright©
2011 Dow Jones & Co. All rights reserved. |
35
|
|
ITEM 6.
|
SELECTED
FINANCIAL DATA
|
The following selected financial data for the years ended
December 31, 2010, 2009, 2008, 2007, and 2006 have been
derived from the financial statements of Emisphere and notes
thereto, which have been audited by our independent registered
public accounting firm. We recognize expense for our share-based
compensation in accordance with FASB ASC 718,
Compensation-Stock Compensation, which
requires that the costs resulting from all stock based payment
transactions be recognized in the financial statements at their
fair values. Results from prior periods have not been restated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009 Restated(1)
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands, except per share data)
|
|
|
Revenue
|
|
$
|
100
|
|
|
$
|
92
|
|
|
$
|
251
|
|
|
$
|
4,077
|
|
|
$
|
7,259
|
|
Cost of goods sold
|
|
|
22
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
2,495
|
|
|
|
4,046
|
|
|
|
12,785
|
|
|
|
21,076
|
|
|
|
18,892
|
|
General and administrative expenses
|
|
|
7,963
|
|
|
|
10,068
|
|
|
|
9,176
|
|
|
|
14,459
|
|
|
|
11,693
|
|
Other costs and expenses
|
|
|
835
|
|
|
|
(422
|
)
|
|
|
779
|
|
|
|
1,083
|
|
|
|
3,802
|
|
Restructuring charge
|
|
|
50
|
|
|
|
(356
|
)
|
|
|
3,831
|
|
|
|
|
|
|
|
|
|
(Income) expense from lawsuit, net
|
|
|
278
|
|
|
|
1,293
|
|
|
|
|
|
|
|
(11,890
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
11,621
|
|
|
|
14,629
|
|
|
|
26,571
|
|
|
|
24,728
|
|
|
|
34,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(11,543
|
)
|
|
|
(14,552
|
)
|
|
|
(26,320
|
)
|
|
|
(20,651
|
)
|
|
|
(27,128
|
)
|
Beneficial conversion of convertible security
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,215
|
)
|
Sale of patent
|
|
|
500
|
|
|
|
500
|
|
|
|
1,500
|
|
|
|
|
|
|
|
|
|
Research and development tax credit
|
|
|
244
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of derivative instruments
|
|
|
(23,651
|
)
|
|
|
(2,473
|
)
|
|
|
2,220
|
|
|
|
5,057
|
|
|
|
(1,390
|
)
|
Interest expense
|
|
|
(3,595
|
)
|
|
|
(659
|
)
|
|
|
(2,956
|
)
|
|
|
(2,615
|
)
|
|
|
(2,335
|
)
|
Loss on extinguishment of debt
|
|
|
(17,014
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing fees
|
|
|
(1,858
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(56,909
|
)
|
|
|
(16,821
|
)
|
|
|
(24,388
|
)
|
|
|
(16,928
|
)
|
|
|
(41,766
|
)
|
Net loss per share basic
|
|
|
(1.23
|
)
|
|
|
(0.49
|
)
|
|
|
(0.80
|
)
|
|
|
(0.58
|
)
|
|
|
(1.58
|
)
|
Net loss per share diluted
|
|
|
(1.23
|
)
|
|
|
(0.49
|
)
|
|
|
(0.80
|
)
|
|
|
(0.76
|
)
|
|
|
(1.58
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009 Restated(1)
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, restricted cash and investments
|
|
$
|
5,326
|
|
|
$
|
3,566
|
|
|
$
|
7,469
|
|
|
$
|
14,100
|
|
|
$
|
21,533
|
|
Working capital (deficit)
|
|
|
(20,568
|
)
|
|
|
(20,441
|
)
|
|
|
(7,954
|
)
|
|
|
9,868
|
|
|
|
13,377
|
|
Total assets
|
|
|
7,276
|
|
|
|
5,587
|
|
|
|
10,176
|
|
|
|
19,481
|
|
|
|
28,092
|
|
Derivative instruments
|
|
|
34,106
|
|
|
|
10,780
|
|
|
|
267
|
|
|
|
2,487
|
|
|
|
6,498
|
|
Long-term liabilities and deferrals
|
|
|
51,966
|
|
|
|
11,669
|
|
|
|
31,531
|
|
|
|
27,648
|
|
|
|
24,744
|
|
Accumulated deficit
|
|
|
(480,943
|
)
|
|
|
(424,034
|
)
|
|
|
(433,688
|
)
|
|
|
(409,300
|
)
|
|
|
(392,372
|
)
|
Stockholders deficit
|
|
|
(82,520
|
)
|
|
|
(35,227
|
)
|
|
|
(37,028
|
)
|
|
|
(13,674
|
)
|
|
|
(6,106
|
)
|
|
|
|
(1) |
|
For a description of such restatement of the Companys
financial statements see Note 19 of the Notes to the
Financials contained in this Annual Report. |
36
|
|
ITEM 7.
|
MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Managements Discussion and Analysis of Financial
Conditions and Results of Operations (MD&A) is provided to
supplement the accompanying financial statements and notes in
Item 8 to help provide an understanding of our financial
condition, changes in our financial condition and results of
operations. To supplement its audited financial statements
presented in accordance with US GAAP, the company is providing a
comparison of operating results describing net income and
operating expenses which removed certain non-cash and one-time
or nonrecurring charges and receipts. The Company believes that
this presentation of net income and operating expense provides
useful information to both management and investors concerning
the approximate impact of the items above. The Company also
believes that considering the effect of these items allows
management and investors to better compare the Companys
financial performance from period to period and to better
compare the Companys financial performance with that of
its competitors. The presentation of this additional information
is not meant to be considered in isolation of, or as a
substitute for, results prepared in accordance with US GAAP.
CAUTION
CONCERNING FORWARD-LOOKING STATEMENTS
The following discussion and analysis contain forward-looking
statements that involve risks and uncertainties. When used in
this report, the words, intend,
anticipate, believe,
estimate, plan, expect and
similar expressions as they relate to us are included to
identify forward-looking statements. Our actual results could
differ materially from those anticipated in these
forward-looking statements as a result of factors, including
those set forth under Item 1A.Risk Factors
(above) and elsewhere in this report. This discussion and
analysis should be read in conjunction with the Selected
Financial Data and the Financial Statements and notes
thereto included in this report.
Overview
Emisphere Technologies, Inc. is a biopharmaceutical company that
focuses on a unique and improved delivery of therapeutic
molecules or nutritional supplements using its
Eligen®
Technology. These molecules could be currently available or are
under development. Such molecules are usually delivered by
injection; in many cases, their benefits are limited due to poor
bioavailability, slow on-set of action or variable absorption.
In those cases, our technology may increase the benefit of the
therapy by improving bioavailability or absorption or by
decreasing time to onset of action. The
Eligen®
Technology can be applied to the oral route of administration as
well other delivery pathways, such as buccal, rectal,
inhalation, intra-vaginal or transdermal. The
Eligen®
Technology can make it possible to orally deliver certain
therapeutic molecules without altering their chemical form or
biological activity.
Eligen®
delivery agents, or carriers, facilitate or enable
the transport of therapeutic molecules across the mucous
membranes of the gastrointestinal tract, to reach the tissues of
the body where they can exert their intended pharmacological
effect.
Since our inception in 1986, substantial efforts and resources
have been devoted to understanding the
Eligen®
Technology and establishing a product development pipeline that
incorporated this technology with selected molecules. Since
2007, Emisphere has undergone many positive changes. A new
senior management team was hired; the
Eligen®
Technology was reevaluated and our corporate strategy was
refocused on commercializing the
Eligen®
Technology as quickly as possible, building high-value
partnerships and reprioritizing the product pipeline. Spending
was redirected and aggressive cost control initiatives were
implemented. We continue to develop potential product candidates
in-house and we demonstrated and enhanced the value of the
Eligen®
Technology as evident in the progress made by our development
partners, Novartis and Novo Nordisk, on their respective product
development programs and in the development of our higher dose
Eligen®
B12 (1000 mcg) product internally. Further development,
exploration and commercialization of the technology entail risk
and operational expenses. However, we have made significant
progress on refocusing our efforts on strategic development
initiatives and cost control and continue to aggressively seek
to reduce non-strategic spending.
37
The application of the
Eligen®
Technology is potentially broad and may provide for a number of
opportunities across a spectrum of therapeutic modalities or
nutritional supplements. During 2010, we continued to develop
our product pipeline utilizing the
Eligen®
Technology with prescription and nonprescription product
candidates. We prioritized our development efforts based on
overall potential returns on investment, likelihood of success,
and market and medical need. Our goal is to implement our
Eligen®
Technology to enhance overall healthcare, including patient
accessibility and compliance, while benefiting the commercial
pharmaceutical marketplace and driving company valuation.
Investments required to continue developing our product pipeline
may be partially paid by income-generating license arrangements
whose value tends to increase as product candidates move from
pre-clinical into clinical development. It is our intention that
incremental investments that may be required to fund our
research and development will be approached incrementally in
order to minimize disruption or dilution.
We are planning to expand our current collaborative
relationships to take advantage of the critical knowledge that
others have gained by working with our technology. We will also
continue to pursue product candidates for internal development
and commercialization. We believe that these internal candidates
must be capable of development with reasonable investments in an
acceptable time period and with a reasonable risk-benefit
profile.
Our product pipeline includes prescription, medical food and
nutritional supplements product candidates that are being
developed in partnership or internally. During 2010 our
development partners Novartis and Novo Nordisk continued or
expanded their development programs and we continued to make
progress on our internally developed
Eligen®
B12 product.
On June 4, 2010, Emisphere entered into the Novartis
Agreement pursuant to which the Company was released and
discharged from its obligations under the Novartis Note in
exchange for: (i) the reduction of future royalty and
milestone payments up to an aggregate amount of
$11.0 million due the Company under the Research
Collaboration and Option Agreement and the Oral Salmon
Calicitonin License Agreement; (ii) the right for Novartis
to evaluate the feasibility of using Emispheres
Eligen®
Technology with two new compounds to assess the potential for
new product development opportunities; and (iii) other
amendments to the Research Collaboration and Option Agreement
and Oral Salmon Calcitonin License Agreement. If Novartis
chooses to develop oral formulations of these new compounds
using the
Eligen®
Technology, the parties will negotiate additional agreements. In
that case, Emisphere could be entitled to receive development
milestone and royalty payments in connection with the
development and commercialization of these potentially new
products. As of the date of the Novartis Agreement, the
outstanding principal balance and accrued interest of the
Novartis Note was approximately $13.0 million.
Novartis, is using our
Eligen®
drug delivery technology in combination with salmon calcitonin,
parathyroid hormone, and human growth hormone. Their most
advanced program utilizing the Companys
Eligen®
Technology is testing an oral formulation of calcitonin to treat
osteoarthritis and osteoporosis. For osteoarthritis, Novartis
completed one Phase III trial and a second Phase III
clinical study is continuing. Novartis is also conducting a
Phase III clinical study for osteoporosis. In its Annual
Results Conference Media Release for the period ended
December 31, 2010, Novartis reported that its planned
submissions for oral calcitonin for the treatment of
osteoporosis and osteoarthritis are scheduled to be filed with
the regulatory authorities during 2011. During October, 2010 the
Company announced that Novartis provided us with information
regarding the first interpretable results of the two-year
Phase III Study 2301 in osteoarthritis conducted by its
license partner Nordic Bioscience with oral calcitonin. The
recently completed study assessed the safety and efficacy of
oral calcitonin in the treatment of osteoarthritis of the knee
and had three co-primary endpoints. Novartis informed Emisphere
that preliminary analysis of the data from this study shows that
the endpoint for the first of three co-primary endpoints, joint
space width narrowing, was not met. Novartis also informed
Emisphere that results regarding the other two co-primary
endpoints indicated clinical efficacy related to symptom
modification (WOMAC scales: pain, function). In addition,
according to Novartis, MRI analyses suggested an effect on
cartilage. Nordic Bioscience and Novartis have indicated that
they are going to continue to work together to further analyze
and evaluate the results of this study. The second two-year
Phase III Study 2302, which also assesses safety and
efficacy of oral calcitonin of patients with osteoarthritis of
the knee, is currently ongoing. Additionally, the Phase III
clinical program of oral calcitonin in osteoporosis continues.
38
During April 2010, we announced that Novartis Pharma AG
initiated a second Phase I trial for an oral PTH-1-34 which uses
Emispheres
Eligen®
Technology, and is in development for the treatment of
postmenopausal osteoporosis. The study is a partially blinded,
placebo controlled, active comparator study to explore the
safety, tolerability, pharmacokinetics and pharmacodynamics in
postmenopausal women after daily oral doses of PTH-1-34. The
study has two parts (A and B) and will enroll a total of
approximately up to 120 postmenopausal women. In Part A of
the trial, ascending doses of oral PTH-1-34 using the
Eligen®
Technology will be tested for safety, tolerability and
pharmacokinetics and compared to
Forsteo®.
In Part B, in addition to safety and tolerability of oral
PTH-1-34 using the
Eligen®
Technology, pharmacodynamic responses will be measured by bone
biomarker levels and bone mineral density, and compared to
Forsteo®.
The first patient was enrolled in April 2010.
Novo Nordisk is using our
Eligen®
drug delivery technology in combination with its proprietary
GLP-1 receptor agonists and insulins. During December 2010, the
Company entered into an exclusive Development and License
Agreement with Novo Nordisk to develop and commercialize oral
formulations of Novo Nordisks insulins using
Emispheres
Eligen®
Technology. This was the second license agreement between the
two companies. The first agreement, for the development of oral
formulations of GLP-1 receptor agonists, was signed in June
2008, with a potential drug currently in a Phase I clinical
trial. The Insulin agreement included $57.5 million in
potential product development and sales milestone payments to
Emisphere, of which $5 million was paid upon signing, as
well as royalties on sales. This extended partnership with Novo
Nordisk has the potential to offer significant new solutions to
millions of people with diabetes worldwide and it also serves to
further validate our
Eligen®
Technology.
During January 2010, we announced that Novo Nordisk had
initiated its first Phase I clinical trial with a long-acting
oral GLP-1 analog (NN9924). This milestone released a
$2 million payment to Emisphere, whose proprietary
Eligen®
Technology is used in the formulation of NN9924. GLP-1 is a
natural hormone involved in controlling blood sugar levels. It
stimulates the release of insulin only when blood sugar levels
become too high. GLP-1 secretion is often impaired in people
with Type 2 Diabetes. The aim of this trial, which is being
conducted in the UK, is to investigate the safety, tolerability
and bioavailability of NN9924 in healthy volunteers. The trial
will enroll approximately 155 individuals and results from the
trial are expected in 2011. There are many challenges in
developing an oral formulation of GLP-1, in particular obtaining
adequate bioavailability. NN9924 addresses some of these key
challenges by utilizing Emispheres
Eligen®
Technology to facilitate absorption from the gastrointestinal
tract.
Professor Beglinger is also conducting research assessing the
feasibility of using the
Eligen®
Technology combined with PYY3-36 and native GLP-1, as a
potential treatment for obesity. During September 2010 we
announced that a clinical study conducted by Professor Beglinger
found that the Companys proprietary oral SNAC (Sodium
N-[8-(2-hydroxybenzoyl) Amino] Caprylate (SNAC), in
combination with two digestive hormones, was successful in
reducing food intake and increasing satiety in healthy male
subjects. The study was published in the August 18, 2010
online edition of the American Journal of Clinical
Nutrition, the official publication of the American Society
for Nutrition. As described in the publication, 12 healthy male
subjects were studied in a randomized double-blind,
placebo-controlled 4-way crossover trial. Each subject received
(in random order) 2.0 mg native GLP-1, 1.0 mg PYY3-36,
or 2.0 mg native GLP-1, plus 1.0 mg PYY3-36.
Researchers observed that both digestive hormones, native GLP-1
and PYY3-36, were rapidly absorbed from the gut, leading to
plasma concentrations several times higher than those in
response to a normal meal. native GLP-1 alone, but not PYY3-36,
significantly reduced total food intake. Co-administration of
both hormones, taken in combination with SNAC in a single oral
dose, reduced both total food intake by 21.5 percent, and
increased fullness at meal onset (P <0.05). The
24-hour food
intake was not affected by the single oral administration of the
native hormones likely due to their short half-life. The two
digestive hormones utilized in the study are released naturally
in proportion to ingested calories and signal
satiety, or fullness, to the brain. SNAC, which is
based on Emispheres
Eligen®
Technology, facilitates transport of these and other hormones
with low oral bioavailability across biological membranes, such
as those of the gastrointestinal tract. Emisphere had previously
announced that SNAC had achieved Generally Recognized as Safe
(GRAS) status for its intended use in combination
with nutrients added to food and dietary supplements.
39
The Company is developing an oral formulation of
Eligen®
B12 (1000 mcg) for use by B12 deficient individuals. During the
fourth quarter 2010, the Company completed a clinical trial
which showed that oral
Eligen®
B12 (1000 mcg) can efficiently and quickly restore Vitamin B12
levels in deficient individuals as effectively as the injectable
formulation, which is the current standard of care. The results
from that clinical trial have been submitted for publication. We
also conducted market research to help assess the potential
commercial opportunity for our potential
Eligen®
B12 (1000 mcg) product. Currently, we are evaluating the results
of our clinical trials and market research and exploring
alternative development and commercialization options with the
purpose of maximizing the commercial and health benefits
potential of our
Eligen®
B12 asset.
Vitamin B12 is an important nutrient that is poorly absorbed in
the oral form. In most healthy people, Vitamin B12 is absorbed
in a receptor-mediated pathway in the presence of an intrinsic
factor. A large number of people take B12 supplements by the
oral route, many in megadoses, and by injection. Currently, it
is estimated that at least five million people in the
U.S. are taking 40 million injections of Vitamin B12
per year to treat a variety of debilitating medical conditions.
Another estimated five million people are consuming more than
600 million tablets of Vitamin B12 orally. The
international market is larger than the U.S. market. Many
B12 deficient patients suffer from pernicious anemia and
neurological disorders and many of them are infirm or elderly.
Vitamin B12 deficiency can cause severe and irreversible damage,
especially to the brain and nervous system. At levels only
slightly lower than normal, a variety of symptoms such as
fatigue, depression, and poor memory may be experienced.
During April 2010, the Company had announced that interim data
from its recently completed study demonstrated that its oral
Eligen®
B12 (1000 mcg) given to individuals with low B12 levels restored
normal B12 serum concentrations. Normal levels of serum B12 were
achieved by all study participants who had taken oral
Eligen®
B12 (1000 mcg) 15 days into the
90-day study
when the first blood samples were taken. This data, in Abstract
Number 8370, was presented at the Experimental Biology 2010
Conference in Anaheim, California. In this open-label,
randomized, parallel-group,
90-day
study, serum cobalamin (B12) and holotranscobalamin (active B12)
were collected and measured at Baseline, Day 15, Day 31, Day 61
and Day 91. A total of 49 study participants were enrolled (26
on IM injection and 23 on oral) and received either nine 1000
mcg intramuscular injections of Vitamin B12 or once daily
tablets of oral
Eligen®
B12 (1000 mcg). The results from the interim analysis showed
that serum cobalamin and active B12 returned to the normal range
with both products and normalization was maintained. With
participants in the oral
Eligen®
B12 (1000 mcg) group showing the ability to rapidly achieve
normalized serum and active B12 levels, the study illustrates
the potential of the
Eligen®
Technology and of the high dose, oral
Eligen®
B12 (1000 mcg) formulation to offer an alternative to painful
and inconvenient IM injections.
Our other product candidates in development are in earlier or
preclinical research phases, and we continue to assess them for
their compatibility with our technology and market need. Our
intent is to seek partnerships with pharmaceutical and
biotechnology companies for certain of these products. We plan
to expand our pipeline with product candidates that demonstrate
significant opportunities for growth. During March 2010,
Emisphere and Alchemia Ltd. (ASX:ACL) announced that they would
join efforts to develop an oral formulation of the
anti-coagulant drug fondaparinux with Emispheres
Eligen®
Technology. Fondaparinux, an anti-coagulant used for the
prevention of deep vein thrombosis, is marketed in injectable
form as
Arixtra®
by GlaxoSmithKline.
Arixtra®
has been off patent since 2002 but, due to the complexity of its
synthesis, there is currently no approved generic or alternative
source of commercial scale active pharmaceutical ingredient
(API). Alchemia has developed a novel, patent
protected, synthesis for the manufacture of fondaparinux at
commercial scale. In March 2009, Alchemias manufacturing
and U.S. marketing partner, Dr. Reddys Laboratories
(NYSE: RDY) submitted an ANDA to the U.S. FDA for a generic
version of the injectable form of fondaparinux. We believe an
oral formulation of fondaparinux could dramatically increase the
market potential for fondaparinux. Based on what we know from
our experience with other chemically-related anti-coagulants,
the profile of fondaparinux should fit very well with the
Eligen®
Technology given its half life and safety profile. Although
developing an oral formulation of an injectable compound is
always challenging, this project could produce substantial
benefits for the medical community. The combination of
Emispheres delivery technology and Alchemias
fondaparinux may ultimately allow us to bring an oral
anti-coagulant to
40
market in an accelerated fashion. Alchemia has already seen
preclinical data suggesting that enhanced levels of oral
absorption can be achieved for fondaparinux. If the dose
formulated with the
Eligen®
Technology can be successfully optimized, it could open up a
host of medically and commercially compelling opportunities for
fondaparinux, Alchemia plans to evaluate a number of different
formulations initially in order to optimize oral bioavailability
and pharmacokinetics, with the aim of then rapidly moving into
human clinical studies.
By expanding our relationship with Novo Nordisk; and by settling
the Novartis Note on non-dilutive terms (see Note 8 to the
Financial Statements contained in this report) the Company
strengthened its Balance Sheet and demonstrated and enhanced the
value of the
Eligen®
Technology. By focusing on improving operational efficiency, we
have strengthened our financial foundation while maintaining our
focus on advancing and commercializing the
Eligen®
Technology. By closing our research and development facility in
Tarrytown, NY and utilizing independent contractors to conduct
essential research and development, we reduced our annual cash
burn from operating activities. Additionally, we have
accelerated the commercialization of the
Eligen®
Technology in a cost effective way and gained operational
efficiencies by tapping into more advanced scientific processes
independent contractors can provide.
Liquidity
and Capital Resources
Since our inception in 1986, we have generated significant
losses from operations and we anticipate that we will continue
to generate significant losses from operations for the
foreseeable future.
As of December 31, 2010, our working capital deficit was
$20.6 million, our accumulated deficit was approximately
$480.9 million and our stockholders deficit was
$82.5 million. Our operating loss was $11.5 million,
$14.6 million and $26.3 million for the years ended
December 31, 2010, 2009, and 2008, respectively. Our net
loss was $56.9 million, $16.8 million, and
$24.4 million for the years ended December 31, 2010,
2009, and 2008, respectively. Our operating and net losses for
2008 included a $3.8 million one-time restructuring charge
which represented our best estimate of current and future costs
associated with the closure of our research and development
facility in Tarrytown, NY. Our net cash outlays from operations
and capital expenditures were $4.9 million,
$11.9 million and $6.8 million for the years ended
December 31, 2010, 2009 and 2008, respectively. Net cash
outlays include receipts of deferred revenue of
$7.1 million, $0.2 million, and $11.3 million for
2010, 2009 and 2008, respectively. Our stockholders
deficit was $82.5 million, $35.2 million and
$37.0 million as of December 31, 2010, 2009 and 2008,
respectively.
We have limited capital resources and operations to date have
been funded primarily with the proceeds from collaborative
research agreements, public and private equity and debt
financings and income earned on investments. We anticipate that
we will continue to generate significant losses from operations
for the foreseeable future, and that our business will require
substantial additional investment that we have not yet secured.
As of December 31, 2010, total cash, cash equivalents and
restricted cash were $5.6 million. We anticipate that our
existing capital resources, without implementing cost
reductions, raising additional capital, or obtaining substantial
cash inflows from potential partners for our products, will
enable us to continue operations through approximately June
2011. However, this expectation is based on the current
operating plan that could change as a result of many factors and
additional funding may be required sooner than anticipated.
These conditions raise substantial doubt about our ability to
continue as a going concern. The audit report prepared by our
independent registered public accounting firm relating to our
financial statements for the year ended December 31, 2010
includes an explanatory paragraph expressing substantial doubt
about our ability to continue as a going concern.
While our plan is to raise capital when needed
and/or to
pursue partnering opportunities, we cannot be sure how much we
will need to spend in order to develop, market and manufacture
new products and technologies in the future. We expect to
continue to spend substantial amounts on research and
development, including amounts spent on conducting clinical
trials for our product candidates. Further, we will not have
sufficient resources to develop fully any new products or
technologies unless we are able to raise substantial additional
financing on acceptable terms or secure funds from new or
existing partners. We cannot assure you that financing will be
available on favorable terms or at all. Additionally, these
conditions may increase the cost to raise capital. If additional
capital is raised through the sale of equity or convertible debt
securities, the
41
issuance of such securities would result in dilution to our
existing stockholders. Additionally, these conditions may
increase costs to raise capital
and/or
result in further dilution. Our failure to raise capital when
needed would adversely affect our business, financial condition
and results of operations, and could force us to reduce or cease
our operations.
If we are successful in raising additional capital to continue
operations, our business will still require substantial
additional investment that we have not yet secured. Further, we
will not have sufficient resources to fully develop new products
or technologies unless we are able to raise substantial
additional financing on acceptable terms or secure funds from
new or existing partners. We cannot assure you that financing
will be available on favorable terms or at all. For further
discussion, see Part I, Item 1A Risk
Factors.
During the year ended December 31, 2010, our cash liquidity
(consisting of $5.6 million cash at December 31,
2010) increased as follows:
Cash
and Cash Equivalents:
|
|
|
|
|
|
|
(In thousands)
|
|
|
At December 31, 2009
|
|
$
|
3,825
|
|
At December 31, 2010
|
|
|
5,586
|
|
|
|
|
|
|
Increase in cash and cash equivalents
|
|
$
|
1,761
|
|
|
|
|
|
|
The increase (decrease) in cash and cash equivalents is
comprised of the following components for the years ended
December 31:
|
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Proceeds, net, from issuance of equity securities
|
|
$
|
6,700
|
|
|
$
|
7,300
|
|
Proceeds from notes payable
|
|
|
500
|
|
|
|
|
|
Proceeds from collaboration, sale of patent, real estate
sublease and other projects
|
|
|
8,100
|
|
|
|
1,500
|
|
|
|
|
|
|
|
|
|
|
Sources of cash and cash equivalents
|
|
|
15,300
|
|
|
|
8,800
|
|
|
|
|
|
|
|
|
|
|
Cash used in operations
|
|
|
13,000
|
|
|
|
12,400
|
|
Repayment of debts
|
|
|
500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uses of cash and cash equivalents
|
|
|
13,500
|
|
|
|
12,400
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
$
|
1,800
|
|
|
$
|
(3,600
|
)
|
During the year ended December 31, 2010, our working
capital liquidity decreased by $0.2 million as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
Change
|
|
|
|
(In thousands)
|
|
|
|
|
|
Current assets
|
|
$
|
6,100
|
|
|
$
|
4,100
|
|
|
$
|
2,000
|
|
Current liabilities
|
|
|
26,700
|
|
|
|
24,500
|
|
|
|
2,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital (deficiency)
|
|
$
|
(20,600
|
)
|
|
$
|
(20,400
|
)
|
|
$
|
(200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in current assets is driven primarily by the
increase in cash and cash equivalents. The increase in current
liabilities is driven primarily by an increase in the derivative
instrument liability as a result of the increase in the price of
our common stock.
Primary
Sources of Cash
During 2010, we received net proceeds of $6.7 million
through the issuance of common stock and associated derivative
instruments from the August 2010 Financing. We also received
$5.0 million as an upfront
42
payment from Novo Nordisk in connection with the development and
license agreement to develop and commercialize oral formulations
of Novo Nordisks insulins using the Companys
proprietary delivery agents (the Insulin Agreement),
and we received a $2.0 million milestone payment from Novo
Nordisk for their initiation of a Phase I clinical trial in
connection with the 2008 development and license agreement with
Novo Nordisk to develop an oral formulation of GLP-1 receptor
agonists (the GLP-1 License Agreement). Also during
2010, we received a $0.5 million installment payment for
sale of certain Emisphere patents and patent application
relating to diketopiparazine technology to MannKind Corporation
and $0.5 million from MHR from the issuance of a note
payable.
During 2009, we received net proceeds of $7.3 million
through the issuance of common stock and associated derivative
instruments from the August 2009 registered direct and private
placement offerings. We also received $1.0 million net
proceeds from the sale of our equipment utilized in the former
laboratory facility located at 765 Old Saw Mill River Road,
Tarrytown, NY. Also during 2009, we received a $0.5 million
installment payment for sale of certain Emisphere patents and a
patent application relating to diketopiparazine technology to
MannKind Corporation.
During 2008, we received a $10.0 million upfront payment
and reimbursement of $1.3 million in costs from Novo
Nordisk in connection with GLP-1 License Agreement. Also during
2008, we received an initial $1.5 million payment for sale
of certain Emisphere patents and a patent application relating
to diketopiparazine technology to MannKind Corporation and $800
thousand in sublease and related payments in connection with
sublease agreements for space at our laboratory and office
facilities located at Tarrytown, NY.
Restatement
of Previously Issued Financial Statements
While preparing its financial statements for the 12 months
ended December 31, 2010, the Company the Company reviewed
its accounting for certain non-cash transactions and determined
that its adoption of Financial Accounting Standards Board
Accounting Codification Topic
815-40-15-5,
Evaluating Whether an Instrument Is Considered Indexed
to an Entitys Own Stock (FASB
ASC 815-40-15-5)
effective January 1, 2009, was not properly accounted for
in accordance with FASB
ASC 835-30-35-2
The Interest Method (FASB
ASC 835-30-35-2).
Furthermore, as a consequence of changing its accounting for the
adoption of FASB
ASC 815-40-15-5,
the Company reevaluated its accounting for the modification of
the MHR Convertible Notes in connection with the Novartis
Agreement and the MHR Letter Agreement during June 2010 and
determined that, in light of the changes in accounting for
adoption of FASB
ASC 815-40-15-5,
the modification of the MHR Convertible Notes should have been
accounted for as extinguishment of debt in accordance with FASB
ASC 470-50,
Modifications and Extinguishments.
The Company evaluated the effect of these changes on its
financial statements and determined that the changes were
material. Consequently, the Company decided to restate its
financial statements previously reported on
Forms 10-Q
for the periods ended March 31, June 30, and
September 30, 2009 and 2010, and on
Form 10-K
for the period ended December 2009. The restatements primarily
reflect adjustments to:
|
|
|
|
|
correct for the overstatement of interest expense reported on
Forms 10-Q
for the periods ended March 31, June 30, and
September 30, 2009 and March 31, and
September 30, 2010, and on
Form 10-K
for the period ended December 2009, in connection with the
adoption of FASB ASC
815-40-15-5
|
|
|
|
correct for the overstatement of interest expense and
understatement of loss on extinguishment of debt reported on
Form 10-Q
for the period ended June 30, 2010 in connection with the
reevaluation of the modification of the MHR Convertible Notes
during June 2010
|
None of the accounting changes discussed above had any impact on
the Companys cash position, its cash flows or its future
cash requirements.
43
Results
of Operations
Year
Ended December 31, 2010 Compared to Year Ended
December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2010
|
|
|
2009 (Restated)
|
|
|
Change
|
|
|
|
(In thousands)
|
|
|
|
|
|
Revenue
|
|
$
|
100
|
|
|
$
|
92
|
|
|
$
|
8
|
|
Operating expenses
|
|
$
|
11,643
|
|
|
$
|
14,644
|
|
|
$
|
(3,001
|
)
|
Operating loss
|
|
$
|
(11,543
|
)
|
|
$
|
(14,552
|
)
|
|
$
|
3,009
|
|
Change in fair value of derivative instruments
|
|
$
|
(23,651
|
)
|
|
$
|
(2,473
|
)
|
|
$
|
(21,178
|
)
|
Interest expense
|
|
$
|
(3,595
|
)
|
|
$
|
(659
|
)
|
|
$
|
(2,936
|
)
|
Loss on extinguishment of debt
|
|
$
|
(17,014
|
)
|
|
$
|
|
|
|
$
|
(17,014
|
)
|
Financing fees
|
|
$
|
(1,858
|
)
|
|
$
|
|
|
|
$
|
(1,858
|
)
|
Other non-operating income (expenses)
|
|
$
|
753
|
|
|
$
|
863
|
|
|
$
|
(110
|
)
|
Net loss
|
|
$
|
(56,909
|
)
|
|
$
|
(16,821
|
)
|
|
$
|
(40,088
|
)
|
Revenue increased $8 thousand for the year ended
December 31, 2010 compared to December 31, 2009 due
primarily to the recognition of $28 thousand deferred revenue
from development partners from prior years and the receipt of
$72 thousand from the sale of
Eligen®
B12 (100 mcg), compared to the receipt of $92 thousand from the
sale of
Eligen®
B12 (100 mcg) during 2009.
Our principal operating costs include the following items as a
percentage of total expense.
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
December 31, 2010
|
|
December 31, 2009
|
|
Human resource costs, including benefits
|
|
|
36
|
%
|
|
|
35
|
%
|
Professional fees for legal, intellectual property, accounting
and consulting
|
|
|
38
|
%
|
|
|
35
|
%
|
Occupancy for our laboratory and operating space
|
|
|
3
|
%
|
|
|
8
|
%
|
Clinical costs
|
|
|
7
|
%
|
|
|
8
|
%
|
Depreciation and amortization
|
|
|
3
|
%
|
|
|
3
|
%
|
Other
|
|
|
13
|
%
|
|
|
11
|
%
|
Operating expenses, decreased by $3.0 million (20%) as a
result of the following items:
|
|
|
|
|
|
|
(In thousands)
|
|
|
Decrease in human resource costs
|
|
$
|
(900
|
)
|
Decrease in clinical costs and lab fees
|
|
|
(800
|
)
|
Decrease in professional and consulting fees
|
|
|
(800
|
)
|
Decrease in occupancy costs
|
|
|
(800
|
)
|
Reduction in depreciation and amortization
|
|
|
(100
|
)
|
All other
|
|
|
400
|
|
|
|
|
|
|
Net decrease
|
|
$
|
(3,000
|
)
|
|
|
|
|
|
Human resource costs decreased approximately $0.9 million
primarily due to a $0.8 million reduction in non-cash
compensation resulting from an increase in the estimated
forfeiture rate of stock options and a $0.1 million
reduction commensurate with a reduction in personnel during 2010.
Clinical costs and lab fees decreased approximately
$0.8 million primarily due to a decrease of
$0.5 million in costs incurred for our studies and clinical
testing costs, a decrease of $0.2 million in costs to close
of our laboratory facilities in Tarrytown during 2009, and a
$0.06 million decrease in material production costs.
44
Professional and consulting fees decreased approximately
$0.8 million primarily due to a decrease of approximately
$0.5 million in legal fees, a $0.2 million reduction
in fees relating to investor relations, and a $0.1 million
reduction in accounting fees.
Occupancy costs decreased $0.8 million primarily due to the
closure of our laboratory facilities in Tarrytown, NY during
2009.
Depreciation and amortization expense decreased
$0.1 million primarily due to the write-off of leasehold
improvements, laboratory equipment, abandoned furniture,
fixtures and computer hardware in connection with the closure of
the Tarrytown, NY facility during 2009.
All other operating costs increased $0.4 million primarily
due to a $0.5 million fee to terminate our Distributor
Agreement for the marketing, distribution and sale of oral
Eligen®
B12 (100mcg) with Quality Vitamins and Supplements, Inc. during
the third quarter 2010, a $0.7 million gain on the sale of
fixed assets during 2009, and a $0.4 million increase in
restructuring costs related to a credit in 2009, offset by a
$0.4 million decrease in insurance, travel related,
software licensing, maintenance, and other operating expenses
during 2010, and by the incremental accrual of $0.8 million
expense in connection with the final ruling of the arbitrator
awarding legal fees to Dr. Goldberg recorded in 2009.
As a result of the factors above, Emispheres operating
expenses were $11.6 million for the year ended
December 31, 2010, which represents a decrease of
$3.0 million or 21% compared to operating expenses for the
year ended December 31, 2009.
Other non-operating expense increased by approximately
$43.1 million for the year ended December 31, 2010 in
comparison to the same period last year due primarily to a
$21.2 million increase in the change in the value of
derivative instruments, a $21.8 million increase in
interest expense due primarily to the extinguishment of debt of
$17.0 million and financing fees of $1.9 million associated with
warrants and promissory notes issued to MHR in connection with
the Novartis Agreement and the letter agreement entered into
with MHR in connection therewith (the MHR Letter
Agreement). Expense from the change in the fair value of
derivative instruments for 2010 and 2009 is the result of an
increase in stock price from $1.06 on December 31, 2009 to
$2.41 on December 31, 2010 and from the increase in stock
price from $0.79 on December 31, 2008 to $1.06 on
December 31, 2009, the addition of 5,246,292 warrants in
connection with the August 2010 Financing, 865,000 warrants to
MHR for consent of the Novartis Agreement and 975,000 warrants
to MHR for consent to the August 2010 offering. The change in
value of derivative instruments and increases in value of the
underlying shares of the Companys common stock increases
the liability which is recognized as a corresponding loss in the
Companys operating statement, while decreases in the value
of the Companys common stock decrease the value of the
liability with a corresponding gain recognized in the
Companys operating statement. Future gains and losses
recognized in the Companys operating results from changes
in value of the derivative instrument liability are based in
part on the fair value of the Companys common stock which
is outside the control of the Company. These potential future
gains and losses could be material.
As a result of the above factors, we reported a net loss of
$56.9 million, which was $40.1 million (238%) greater
than the net loss of $16.8 million for the year ended
December 31, 2009.
45
Year
Ended December 31, 2009 Compared to Year Ended
December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
|
|
December 31,
|
|
|
|
|
2009
|
|
2008
|
|
Change
|
|
|
(In thousands)
|
|
|
|
Revenue
|
|
$
|
92
|
|
|
$
|
251
|
|
|
$
|
(159
|
)
|
Operating expenses (including a $3.8 million restructuring
charge in 2008 and a $0.4 million reduction to the
restructuring liability in 2009 relating to the closure of the
facility in Tarrytown, NY)
|
|
$
|
14,644
|
|
|
$
|
26,571
|
|
|
$
|
11,927
|
|
Operating loss
|
|
$
|
(14,552
|
)
|
|
$
|
(26,320
|
)
|
|
$
|
11,768
|
|
Change in fair value of derivative instruments
|
|
$
|
(2,473
|
)
|
|
$
|
2,220
|
|
|
$
|
(4,693
|
)
|
Interest Expense
|
|
$
|
(659
|
)
|
|
$
|
(2,956
|
)
|
|
$
|
2,297
|
|
Other non-operating income (expenses)
|
|
$
|
863
|
|
|
$
|
2,668
|
|
|
$
|
(1,805
|
)
|
Net loss
|
|
$
|
(16,821
|
)
|
|
$
|
(24,388
|
)
|
|
$
|
7,567
|
|
Revenue decreased $0.2 million for the year ended
December 31, 2009 compared to December 31, 2008, due
to decreased receipts from development partners, the deferral of
cost reimbursements received from Novo Nordisk in connection
with the development of an oral formulation of GLP-1 receptor
agonists in accordance with the Companys revenue
recognition policy; offset by the receipt of $92 thousand B12
operating revenue during 2009. Revenue reported in 2009 relates
to the sales of low dose
Eligen®
B12 to Life Extension Foundation.
Our principal operating costs include the following items as a
percentage of total expenses:
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
December 31, 2009
|
|
December 31, 2008
|
|
Human resource costs, including benefits
|
|
|
35
|
%
|
|
|
42
|
%
|
Professional fees for legal, intellectual property, accounting
and consulting
|
|
|
35
|
%
|
|
|
22
|
%
|
Occupancy for our laboratory and operating space
|
|
|
8
|
%
|
|
|
19
|
%
|
Clinical costs
|
|
|
8
|
%
|
|
|
5
|
%
|
Depreciation and amortization
|
|
|
3
|
%
|
|
|
4
|
%
|
Other
|
|
|
11
|
%
|
|
|
8
|
%
|
Operating expenses, decreased by $11.9 million (45%) as a
result of the following items:
|
|
|
|
|
|
|
(In thousands)
|
|
|
Decrease in human resource costs
|
|
$
|
(4,400
|
)
|
Increase in clinical costs and lab fees
|
|
|
400
|
|
Increase in professional and consulting fees
|
|
|
200
|
|
Decrease in occupancy costs
|
|
|
(3,300
|
)
|
Reduction in depreciation and amortization
|
|
|
(500
|
)
|
All other
|
|
|
(4,300
|
)
|
|
|
|
|
|
Net decrease
|
|
$
|
(11,900
|
)
|
|
|
|
|
|
Human resource costs decreased approximately $4.4 million
primarily due to an 80% reduction in headcount from 87 as of
December 31, 2008 to 17 as of December 31, 2009.
Clinical costs and lab fees increased approximately
$0.4 million primarily as a result of studies and clinical
testing related to the B12 program.
Professional and consulting fees increased approximately
$0.2 million primarily due to an increase of approximately
$1.0 million in legal fees offset by a $0.5 million
reduction in consulting fees in connection
46
with the completion of toxicology and clinical studies;
$0.2 million reduction in accounting fees; and a
$0.1 million reduction in various miscellaneous
professional fees.
Occupancy costs decreased $3.3 million primarily due to the
closure of the Tarrytown, NY facility and subsequent termination
of our lease for that facility.
Depreciation and amortization expense decreased
$0.5 million primarily due to the write-off of leasehold
improvements, laboratory equipment, abandoned furniture,
fixtures and computer hardware in connection with the closure of
the Tarrytown, NY facility.
All other operating costs decreased $4.3 million primarily
due to the $3.8 million restructuring charge incurred
during 2008, a $0.4 million adjustment to the restructuring
liability during 2009, an increase of $0.7 million on the
gain on sale of fixed assets during 2009, and $0.7 million
decrease in insurance, travel related, software licensing,
maintenance, and other operating expenses during 2009; offset by
the incremental accrual of $1.3 million expense in
connection with the final ruling of the arbitrator awarding
legal fees to Dr. Goldberg.
As a result of the factors above, Emispheres operating
expenses were $14.6 million for the year ended
December 31, 2009; a decrease of $11.9 million or 45%
compared to operating expenses for the year ended
December 31, 2008.
Other non-operating expense increased by approximately
$4.2 million for the year ended December 31, 2009 in
comparison to the same period last year primarily due to a
$4.7 million increase in the change in the value of
derivative instruments, a $2.3 million decrease in interest
expense due primarily to the adoption of FASB
ASC 815-40-15-5,
a $1.0 million reduction in the gain from sale of patent to
MannKind Corporation, a decrease of $0.6 million in
sublease income during 2009, and a $0.2 million decrease in
investment income. Expense from the change in the fair value of
derivatives instruments for 2009 and 2008 is the result of the
adoption of FASB
ASC 815-40-15-5,
an increase in stock price from $0.79 on December 31, 2008
to $1.06 on December 31, 2009 and from the decrease in
stock price from $2.73 on December 31, 2007 to $0.79 on
December 31, 2008, and the addition of 4,523,755 warrants
in connection with the August 2009 offering. The change in value
of derivative instruments: increases in value of the underlying
shares of the Companys common stock increase the liability
with a corresponding loss recognized in the Companys
operating statement while decreases in the value of the
Companys common stock decrease the value of the liability
with a corresponding gain recognized in the Companys
operating statement. Future gains and losses recognized in the
Companys operating results from changes in value of the
derivative instrument liability are based in part on the fair
value of the Companys common stock which is outside the
control of the Company. Gains and losses could be material.
As a result of the above factors, we reported a net loss of
$16.8 million, compared to a net loss of
$24.4 million, or $7.6 million (31%) lower than the
net loss for the year ended December 31, 2008.
Critical
Accounting Estimates and New Accounting Pronouncements
Critical
Accounting Estimates
The preparation of financial statements in accordance with
accounting principles generally accepted in the
U.S. requires management to make estimates and assumptions
that affect reported amounts and related disclosures in the
financial statements. Management considers an accounting
estimate to be critical if:
|
|
|
|
|
It requires assumptions to be made that were uncertain at the
time the estimate was made, and
|
|
|
|
Changes in the estimate or different estimates that could have
been selected could have a material impact on our results of
operations or financial condition.
|
Share-Based Payments We recognize expense for
our share-based compensation in accordance with FASB
ASC 718, Compensation-stock
Compensation, which establishes standards for
share-based transactions in which an entity receives
employees services for (a) equity instruments of the
entity, such as stock options, or (b) liabilities that are
based on the fair value of the entitys equity instruments
or that may be settled by the issuance of such equity
instruments. FASB ASC 718 requires that companies expense
the fair
47
value of stock options and similar awards, as measured on the
awards grant date. FASB ASC 718 applies to all awards
granted after the date of adoption, and to awards modified,
repurchased or cancelled after that date.
We estimate the value of stock option awards on the date of
grant using the Black-Scholes-Merton (Black-Scholes)
option-pricing model. The determination of the fair value of
share-based payment awards on the date of grant is affected by
our stock price as well as assumptions regarding a number of
complex and subjective variables. These variables include our
expected stock price volatility over the term of the awards,
expected term, risk-free interest rate, expected dividends and
expected forfeiture rates.
If factors change and we employ different assumptions in the
application of FASB ASC 718 in future periods, the
compensation expense that we record under FASB ASC 718 may
differ significantly from what we have recorded in the current
period. There is a high degree of subjectivity involved when
using option pricing models to estimate share-based compensation
under FASB ASC 718. Consequently, there is a risk that our
estimates of the fair values of our share-based compensation
awards on the grant dates may bear little resemblance to the
actual values realized upon the exercise, expiration, early
termination or forfeiture of those share-based payments in the
future. Employee stock options may expire worthless or otherwise
result in zero intrinsic value as compared to the fair values
originally estimated on the grant date and reported in our
financial statements. Alternatively, value may be realized from
these instruments that are significantly in excess of the fair
values originally estimated on the grant date and reported in
our financial statements. During the year ended
December 31, 2010, we do not believe that reasonable
changes in the projections would have had a material effect on
share-based compensation expense.
Revenue Recognition Revenue includes amounts
earned from sales of our oral
Eligen®
B12 (100 mcg) product, collaborative agreements and feasibility
studies. Revenue earned from the sale of oral
Eligen®
B12 (100 mcg) was recognized when the product was shipped, when
all revenue recognition criteria were met in accordance with
Staff Accounting Bulletin No. 104 , Revenue
Recognition (codified under ASC 605 Revenue
Recognition). Our Distributor Agreement for the marketing,
distribution and sale of oral
Eligen®
B12 (100 mcg) with Quality Vitamins and Supplements, Inc. was
terminated during the third quarter 2010. Revenue from
feasibility studies, which are typically short term in nature,
is recognized upon delivery of the study, provided that all
other revenue recognition criteria are met. Revenue from
collaboration agreements are recognized using the proportional
performance method provided that we can reasonably estimate the
level of effort required to complete our performance obligations
under an arrangement and such performance obligations are
provided on a best effort basis and based on expected
payments. Under the proportional performance method,
periodic revenue related to nonrefundable cash payments is
recognized as the percentage of actual effort expended to date
as of that period to the total effort expected for all of our
performance obligations under the arrangement. Actual effort is
generally determined based upon actual hours incurred and
include research and development (R&D)
activities performed by us and time spent for joint steering
committee (JSC) activities. Total expected effort is
generally based upon the total R&D and JSC hours
incorporated into the project plan that is agreed to by both
parties to the collaboration. Significant management judgments
and estimates are required in determining the level of effort
required under an arrangement and the period over which we
expect to complete the related performance obligations.
Estimates of the total expected effort included in each project
plan are based on historical experience of similar efforts and
expectations based on the knowledge of scientists for both the
Company and its collaboration partners. The Company periodically
reviews and updates the project plan for each collaborative
agreement. The most recent reviews took place in January 2010.
In the event that a change in estimate occurs, the change will
be accounted for using the cumulative
catch-up
method which provides for an adjustment to revenue in the
current period. Estimates of our level of effort may change in
the future, resulting in a material change in the amount of
revenue recognized in future periods.
Generally under collaboration arrangements, nonrefundable
payments received during the period of performance may include
time- or performance-based milestones. The proportion of actual
performance to total expected performance is applied to the
expected payments in determining periodic revenue.
However, revenue is limited to the sum of (1) the amount of
nonrefundable cash payments received and (2) the payments
that are contractually due but have not yet been paid.
48
With regard to revenue recognition from collaboration
agreements, the Company previously interpreted expected payments
to equate to total payments subject to each collaboration
agreement. On a prospective basis, the Company has revised its
application of expected payments to equate to a best
estimate of payments. Under this application, expected
payments typically include (i) payments already received
and (ii) those milestone payments not yet received but that
the Company believes are more likely than not of
receiving. Our support for the assertion that the next milestone
is likely to be met is based on the (a) project status
updates discussed at JSC meetings; (b) clinical
trial/development results of prior phases; (c) progress of
current clinical trial/development phases; (d) directional
input of collaboration partners and (e) knowledge and
experience of the Companys scientific staff. After
considering the above factors, the Company believes those
payments included in expected payments are more
likely than not of being received. While this interpretation
differs from that used previously by the Company, it does not
result in any change to previously recognized revenues in either
timing or amount for periods through December 31, 2010.
With regard to revenue recognition in connection with the
Insulins and the GLP-1 License Agreements with Novo Nordisk:
such agreements include multiple deliverables including license
grants, several versions of the Companys
Eligen®
Technology (or carriers), support services and manufacturing.
Emispheres management reviewed the relevant terms of the
Novo Nordisk agreements and determined such deliverables should
be accounted for as a single unit of accounting in accordance
with FASB
ASC 605-25,
Multiple-Element Arrangements since the delivered
license and
Eligen®
Technology do not have stand-alone value and Emisphere does not
have objective evidence of fair value of the undelivered
Eligen®
Technology or the manufacturing value of all the undelivered
items. Such conclusion will be reevaluated as each item in the
arrangement is delivered. Consequently any payments received
from Novo Nordisk pursuant to such agreements, including the
initial $10 million upfront payment and any payments
received for support services in connection with the GLP-1
License Agreement and the $5 million upfront payment from
the Insulins Agreement, will be deferred and included in
Deferred Revenue within our balance sheet. Management cannot
currently estimate when all of such deliverables will be
delivered nor can they estimate when, if ever, Emisphere will
have objective evidence of the fair value for all of the
undelivered items, therefore all payments from Novo Nordisk are
expected to be deferred for the foreseeable future.
As of December 31, 2010 total deferred revenue from the
GLP-1 License Agreement was $13.6 million, comprised of the
$12.0 million non-refundable license fee and
$1.6 million in support services. Total deferred revenue
from the Insulins Agreement was $5 million.
Purchased Technology Purchased technology
represents the value assigned to patents and the rights to use,
sell or license certain technology in conjunction with our
proprietary carrier technology. These assets underlie our
research and development projects related to various research
and development projects.
Warrants Warrants issued in connection with
the equity financing completed in March 2005 and August 2007 and
to MHR have been classified as liabilities due to certain
provisions that may require cash settlement in certain
circumstances. At each balance sheet date, we adjust the
warrants to reflect their current fair value. We estimate the
fair value of these instruments using the Black-Scholes model
which takes into account a variety of factors, including
historical stock price volatility, risk-free interest rates,
remaining term and the closing price of our common stock.
Changes in the assumptions used to estimate the fair value of
these derivative instruments could result in a material change
in the fair value of the instruments. We believe the assumptions
used to estimate the fair values of the warrants are reasonable.
For a more complete discussion on the volatility in market value
of derivative instruments, see Part I, Item 7A
Quantitative and Qualitative Disclosures about Market
Risk.
Equipment and Leasehold Improvements
Equipment and leasehold improvements are stated at cost.
Depreciation and amortization are provided for on a
straight-line basis over the estimated useful life of the asset.
Leasehold improvements are amortized over the life of the lease
or of the improvements, whichever is shorter. Expenditures for
maintenance and repairs that do not materially extend the useful
lives of the respective assets are charged to expense as
incurred. The cost and accumulated depreciation or amortization
of assets retired or sold are removed from the respective
accounts and any gain or loss is recognized in operations.
49
Impairment of Long-Lived Assets We review our
long-lived assets for impairment whenever events and
circumstances indicate that the carrying value of an asset might
not be recoverable. An impairment loss, measured as the amount
by which the carrying value exceeds the fair value, is triggered
if the carrying amount exceeds estimated undiscounted future
cash flows. Actual results could differ significantly from these
estimates, which would result in additional impairment losses or
losses on disposal of the assets. During the year ended
December 31, 2008 we recognized an approximately
$1.0 million charge to write down the value of leasehold
improvements in connection with the restructuring charge to
estimate current and future costs to close the laboratory and
office facility located in Tarrytown, NY. In addition, with
regards to the restructuring, we accelerated the useful life of
approximately $0.2 million in leasehold improvements for a
portion of the laboratory facility in Tarrytown that we
continued to use through January 29, 2009. Approximately
$0.1 million in additional depreciation expense was
recognized during December 2008 and approximately
$0.1 million during January 2009.
Clinical Trial Accrual Methodology Clinical
trial expenses represent obligations resulting from our
contracts with various research organizations in connection with
conducting clinical trials for our product candidates. We
account for those expenses on an accrual basis according to the
progress of the trial as measured by patient enrollment and the
timing of the various aspects of the trial. Accruals are
recorded in accordance with the following methodology:
(i) the costs for period expenses, such as investigator
meetings and initial
start-up
costs, are expensed as incurred based on managements
estimates, which are impacted by any change in the number of
sites, number of patients and patient start dates;
(ii) direct service costs, which are primarily on-going
monitoring costs, are recognized on a straight-line basis over
the life of the contract; and (iii) principal investigator
expenses that are directly associated with recruitment are
recognized based on actual patient recruitment. All changes to
the contract amounts due to change orders are analyzed and
recognized in accordance with the above methodology. Change
orders are triggered by changes in the scope, time to completion
and the number of sites. During the course of a trial, we adjust
our rate of clinical expense recognition if actual results
differ from our estimates.
New
Accounting Pronouncements
In December 2010, the Financial Accounting Standards Board
(FASB) issued Accounting Standards Update (ASU)
2010-29,
Business Combinations (ASC Topic 805): Disclosure of
Supplementary Pro Forma Information for Business
Combinations. The amendments in this ASU affect any
public entity as defined by ASC Topic 805 that enters into
business combinations that are material on an individual or
aggregate basis. The amendments in this ASU specify that if a
public entity presents comparative financial statements, the
entity should disclose revenue and earnings of the combined
entity as though the business combination(s) that occurred
during the current year had occurred as of the beginning of the
comparable prior annual reporting period only. The amendments
also expand the supplemental pro forma disclosures to include a
description of the nature and amount of material, nonrecurring
pro forma adjustments directly attributable to the business
combination included in the reported pro forma revenue and
earnings. The amendments are effective prospectively for
business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period
beginning on or after December 15, 2010. Early adoption is
permitted. The Company does not expect adoption of ASU
2010-29 to
have a material impact on the Companys results of
operations or financial condition.
In December 2010, the FASB issued ASU
2010-28,
Intangibles Goodwill and Other (ASC Topic
350): When to Perform Step 2 of the Goodwill Impairment Test for
Reporting Units with Zero or Negative Carrying Amounts.
The amendments in this ASU modify Step 1 of the goodwill
impairment test for reporting units with zero or negative
carrying amounts. For those reporting units, an entity is
required to perform Step 2 of the goodwill impairment test if it
is more likely than not that a goodwill impairment exists. In
determining whether it is more likely than not that a goodwill
impairment exists, an entity should consider whether there are
any adverse qualitative factors indicating that an impairment
may exist. The qualitative factors are consistent with the
existing guidance and examples, which require that goodwill of a
reporting unit be tested for impairment between annual tests if
an event occurs or circumstances change that would more likely
than not reduce the fair value of a reporting unit below its
carrying amount. For public entities, the amendments in this ASU
are effective for fiscal years, and interim periods within those
years, beginning after December 15,
50
2010. Early adoption is not permitted. The Company does not
expect the adoption of ASU
2010-28 to
have a material impact on the Companys results of
operations or financial condition.
In April 2010, the FASB issued ASU
2010-17,
Revenue Recognition Milestone Method
(ASU
2010-17).
ASU 2010-17
provides guidance on the criteria that should be met for
determining whether the milestone method of revenue recognition
is appropriate. A vendor can recognize consideration that is
contingent upon achievement of a milestone in its entirety as
revenue in the period in which the milestone is achieved only if
the milestone meets all criteria to be considered substantive.
The following criteria must be met for a milestone to be
considered substantive. The consideration earned by achieving
the milestone should (i) be commensurate with either the
level of effort required to achieve the milestone or the
enhancement of the value of the item delivered as a result of a
specific outcome resulting from the vendors performance to
achieve the milestone; (ii) be related solely to past
performance; and (iii) be reasonable relative to all
deliverables and payment terms in the arrangement. No
bifurcation of an individual milestone is allowed and there can
be more than one milestone in an arrangement. Accordingly, an
arrangement may contain both substantive and non-substantive
milestones. ASU
2010-17 is
effective on a prospective basis for milestones achieved in
fiscal years, and interim periods within those years, beginning
on or after June 15, 2010. Management evaluated the
potential impact of ASU
2010-17 and
does not expect its adoption to have a material effect on the
Companys results of operations or financial condition.
In January 2010, the FASB issued ASU
2010-06,
Improving Disclosures about Fair Value Measurements
(ASU
2010-06).
ASU 2010-06
amends ASC 820 to require a number of additional
disclosures regarding fair value measurements. The amended
guidance requires entities to disclose the amounts of
significant transfers between Level 1 and Level 2 of
the fair value hierarchy and the reasons for these transfers,
the reasons for any transfers in or out of Level 3, and
information in the reconciliation of recurring Level 3
measurements about purchases, sales, issuances and settlements
on a gross basis. The ASU also clarifies the requirements for
entities to disclose information about both the valuation
techniques and inputs used in estimating Level 2 and
Level 3 fair value measurements. The amended guidance is
effective for interim and annual financial periods beginning
after December 15, 2009. The adoption of ASU
2010-06 did
not have a significant effect on the Companys financial
statements.
In October 2009, the FASB issued ASU
2009-13,
Multiple-Deliverable Revenue Arrangements, (amendments to
FASB ASC Topic 605, Revenue Recognition ) (ASU
2009-13).
ASU 2009-13
requires entities to allocate revenue in an arrangement using
estimated selling prices of the delivered goods and services
based on a selling price hierarchy. The amendments eliminate the
residual method of revenue allocation and require revenue to be
allocated using the relative selling price method. ASU
2009-13
should be applied on a prospective basis for revenue
arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010, with early adoption
permitted. The Company does not expect adoption of ASU
2009-13 to
have a material impact on the Companys results of
operations or financial condition.
In October 2009, the FASB issued ASU
2009-15,
Accounting for Own-Share Lending Arrangements in
Contemplation of Convertible Debt Issuance or Other
Financing, (ASU-2009-15), which provides
guidance for accounting and reporting for own-share lending
arrangements issued in contemplation of a convertible debt
issuance. At the date of issuance, a share-lending arrangement
entered into on an entitys own shares should be measured
at fair value in accordance with Topic 820 and recognized as an
issuance cost, with an offset to additional paid-in capital.
Loaned shares are excluded from basic and diluted earnings per
share unless default of the share-lending arrangement occurs.
The amendments also require several disclosures including a
description and the terms of the arrangement and the reason for
entering into the arrangement. The effective dates of the
amendments are dependent upon the date the share-lending
arrangement was entered into and include retrospective
application for arrangements outstanding as of the beginning of
fiscal years beginning on or after December 15, 2009. The
adoption of ASU
209-15 did
not have a material impact on the Companys results of
operations or financial condition.
Management does not believe that any other recently issued, but
not yet effective, accounting standards if currently adopted
would have a material effect on the accompanying financial
statements.
51
Off-Balance
Sheet Arrangements
As of December 31, 2010, we had no material off-balance
sheet arrangements.
In the ordinary course of business, we enter into agreements
with third parties that include indemnification provisions
which, in our judgment, are normal and customary for companies
in our industry sector. These agreements are typically with
business partners, clinical sites, and suppliers. Pursuant to
these agreements, we generally agree to indemnify, hold
harmless, and reimburse indemnified parties for losses suffered
or incurred by the indemnified parties with respect to our
product candidates, use of such product candidates, or other
actions taken or omitted by us. The maximum potential amount of
future payments we could be required to make under these
indemnification provisions is unlimited. We have not incurred
material costs to defend lawsuits or settle claims related to
these indemnification provisions. As a result, the estimated
fair value of liabilities relating to these provisions is
minimal. Accordingly, we have no liabilities recorded for these
provisions as of December 31, 2010.
In the normal course of business, we may be confronted with
issues or events that may result in a contingent liability.
These generally relate to lawsuits, claims, environmental
actions or the actions of various regulatory agencies. We
consult with counsel and other appropriate experts to assess the
claim. If, in our opinion, we have incurred a probable loss as
set forth by accounting principles generally accepted in the
U.S., an estimate is made of the loss and the appropriate
accounting entries are reflected in our financial statements.
After consultation with legal counsel, we do not anticipate that
liabilities arising out of currently pending or threatened
lawsuits and claims, including the pending litigation described
in Part I, Item 3 Legal
Proceedings, will have a material adverse effect on
our financial position, results of operations or cash flows.
Contractual
Arrangements
Significant contractual obligations as of December 31, 2010
are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount Due in
|
|
|
|
|
|
|
Less than
|
|
|
1 to 3
|
|
|
3 to 5
|
|
|
More than
|
|
Type of Obligation
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
5 Years
|
|
|
|
(In thousands)
|
|
|
Notes Payable(1)(2)
|
|
$
|
20,385
|
|
|
$
|
|
|
|
$
|
20,385
|
|
|
$
|
|
|
|
$
|
|
|
Derivative liabilities(3)
|
|
|
34,106
|
|
|
|
22,940
|
|
|
|
11,166
|
|
|
|
|
|
|
|
|
|
Operating lease obligations
|
|
|
744
|
|
|
|
353
|
|
|
|
391
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
55,235
|
|
|
$
|
23,293
|
|
|
$
|
31,942
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Amounts include both principal and related interest payments. |
|
(2) |
|
We have outstanding $19.9 million (net of discounts) in
Convertible Notes payable to MHR and its affiliates
(MHR) due September 2012 and convertible at the sole
discretion of MHR into shares of our common stock at a price of
$3.78. Interest at 11% is payable in additional MHR Convertible
Notes rather than in cash. The MHR Convertible Notes are subject
to acceleration upon the occurrence of certain events of
default. We also issued to MHR non-interest bearing promissory
notes for $0.6 million due on June 4, 2012. The notes
were recorded at a discount using a rate of 10% which is being
amortized over the life of the agreements. The notes, net of
discounts, total $0.5 million. |
|
(3) |
|
We have issued warrants to purchase shares of our common stock
which contain provisions requiring us to make a cash payment to
the holders of the warrant for any gain that could have been
realized if the holders exercise the warrants and we
subsequently fail to deliver a certificate representing the
shares to be issued upon such exercise by the third trading day
after such warrants have been exercised. As a result, these
warrants have been recorded at their fair value and are
classified as current liabilities. The value and timing of the
actual cash payments, if any, related to these derivative
instruments could differ materially from the amounts and periods
shown. |
52
|
|
ITEM 7A.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Fair Value of Warrants and Derivative
Liabilities. At December 31, 2010, the value
of derivative instruments was $34.1 million. We estimate
the fair values of these instruments using the Black-Scholes
model which takes into account a variety of factors, including
historical stock price volatility, risk-free interest rates,
remaining term and the closing price of our common stock.
Furthermore, the Company computes the fair value of these
instruments using multiple Black-Scholes model calculations to
account for the various circumstances that could arise in
connection with the contractual terms of said instruments. The
Company weights each Black-Scholes model calculation based on
its estimation of the likelihood of the occurrence of each
circumstance and adjusts relevant Black-Scholes model input to
calculate the value of the derivative at the reporting date. We
are required to revalue this liability each quarter. We believe
that the assumption that has the greatest impact on the
determination of fair value is the closing price of our common
stock. The following table illustrates the potential effect on
the fair value of derivative instruments from changes in the
assumptions made:
|
|
|
|
|
|
|
Increase/(Decrease)
|
|
|
(In thousands)
|
|
25% increase in stock price
|
|
$
|
9,855
|
|
50% increase in stock price
|
|
|
19,884
|
|
5% increase in assumed volatility
|
|
|
789
|
|
25% decrease in stock price
|
|
|
(9,573
|
)
|
50% decrease in stock price
|
|
|
(18,774
|
)
|
5% decrease in assumed volatility
|
|
|
(778
|
)
|
53
|
|
ITEM 8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
|
EMISPHERE
TECHNOLOGIES, INC.
FINANCIAL
STATEMENTS
Index
|
|
|
|
|
|
|
Page
|
|
Emisphere Technologies, Inc.
|
|
|
|
|
|
|
|
55
|
|
|
|
|
57
|
|
|
|
|
58
|
|
|
|
|
59
|
|
|
|
|
60
|
|
|
|
|
61
|
|
|
|
|
62
|
|
54
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Emisphere Technologies, Inc.
We have audited the accompanying balance sheets of Emisphere
Technologies, Inc. as of December 31, 2010 and 2009, and
the related statements of operations, stockholders equity,
and cash flows for the years then ended. These financial
statements are the responsibility of Emisphere Technologies,
Inc.s management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Emisphere Technologies, Inc. as of December 31, 2010 and
2009, and the results of its operations and its cash flows for
the years then ended, in conformity with U.S. generally
accepted accounting principles.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States),
Emisphere Technologies, Inc.s internal control over
financial reporting as of December 31, 2010, based on
criteria established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission. Our report dated March 31, 2011
expressed an opinion that Emisphere Technologies, Inc. had not
maintained effective internal control over financial reporting
as of December 31, 2010, based on criteria established in
Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
The accompanying financial statements have been prepared
assuming that the Company will continue as a going concern. As
discussed in Note 1 to the financial statements, the
Company has suffered recurring losses from operations and its
total liabilities exceed its total assets. This raises
substantial doubt about the Companys ability to continue
as a going concern. Managements plans in regard to these
matters are also described in Note 1. The financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
As discussed in Note 19 to the financial statements, the
2009 financial statements have been restated to correct a
misstatement.
/s/ McGladrey &
Pullen, LLP
McGladrey & Pullen, LLP
New York, New York
March 31, 2011
55
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Emisphere Technologies, Inc.
We have audited Emisphere Technologies, Inc.s internal
control over financial reporting as of December 31, 2010,
based on criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Emisphere
Technologies, Inc.s management is responsible for
maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control
over financial reporting included in the accompanying Controls
and Procedures. Our responsibility is to express an opinion on
the companys internal control over financial reporting
based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, assessing the risk
that a material weakness exists, and testing and evaluating the
design and operating effectiveness of internal control based on
the assessed risk. Our audit also included performing such other
procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our
opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (a) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (b) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (c) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material
misstatement of the companys annual or interim financial
statements will not be prevented or detected on a timely basis.
The following material weakness has been identified and included
in managements assessment. Emisphere Technologies, Inc.
did not maintain effective controls to ensure completeness and
accuracy with regard to the proper recognition, presentation and
disclosure of accounting for interest expense relating to the
accretion of debt discounts on convertible notes. This material
weakness was considered in determining the nature, timing, and
extent of audit tests applied in our audit of the 2010 financial
statements, and this report does not affect our report dated
March 31, 2011 on those financial statements.
In our opinion, because of the effect of the material weakness
described above on the achievement of the objectives of the
control criteria, Emisphere Technologies, Inc. has not
maintained effective internal control over financial reporting
as of December 31, 2010, based on criteria established in
Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
balance sheets of Emisphere Technologies, Inc. as of
December 31, 2010 and 2009, and the related statements of
operations, stockholders equity, and cash flows for the
years then ended and our report dated March 31, 2011
expressed an unqualified opinion.
/s/ McGladrey
and Pullen, LLP
New York, New York
March 31, 2011
56
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Emisphere
Technologies, Inc.:
In our opinion, the statements of operations, of cash flows and
of stockholders (deficit) equity of Emisphere
Technologies, Inc. (the Company) for the year ended
December 31, 2008 present fairly, in all material respects,
the results of operations and cash flows of the Company for the
year ended December 31, 2008, in conformity with accounting
principles generally accepted in the United States of America.
These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audit. We
conducted our audit of these statements in accordance with the
standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant
estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audit
provides a reasonable basis for our opinion.
The financial statements referred to above have been prepared
assuming that the Company will continue as a going concern. As
discussed in Note 1 to the financial statements, the
Company has experienced recurring operating losses, has limited
capital resources and has significant future commitments that
raise substantial doubt about its ability to continue as a going
concern. Managements plans in regard to these matters are
also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of
this uncertainty.
/s/
PricewaterhouseCoopers
LLP
New York, New York
March 16, 2009
57
EMISPHERE
TECHNOLOGIES, INC.
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2009
|
|
|
|
2010
|
|
|
Restated
|
|
|
|
(In thousands,
|
|
|
|
except share data)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,326
|
|
|
$
|
3,566
|
|
Accounts receivable, net of allowance of $0 in 2010 and 2009
|
|
|
14
|
|
|
|
158
|
|
Inventories
|
|
|
260
|
|
|
|
20
|
|
Prepaid expenses and other current assets
|
|
|
496
|
|
|
|
369
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
6,096
|
|
|
|
4,113
|
|
Equipment and leasehold improvements, net
|
|
|
82
|
|
|
|
138
|
|
Restricted cash
|
|
|
260
|
|
|
|
259
|
|
Purchased technology, net
|
|
|
838
|
|
|
|
1,077
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
7,276
|
|
|
$
|
5,587
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Notes payable, including accrued interest and net of related
discount
|
|
$
|
|
|
|
$
|
12,588
|
|
Accounts payable and accrued expenses
|
|
|
2,954
|
|
|
|
4,975
|
|
Derivative instruments:
|
|
|
|
|
|
|
|
|
Related party
|
|
|
17,293
|
|
|
|
3,205
|
|
Others
|
|
|
5,647
|
|
|
|
2,984
|
|
Contract termination liability, current
|
|
|
435
|
|
|
|
|
|
Restructuring charge, current
|
|
|
300
|
|
|
|
750
|
|
Other current liabilities
|
|
|
35
|
|
|
|
52
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
26,664
|
|
|
|
24,554
|
|
Notes payable, including accrued interest and net of related
discount, related party
|
|
|
20,385
|
|
|
|
93
|
|
Derivative instrument, related party
|
|
|
11,166
|
|
|
|
4,591
|
|
Deferred revenue
|
|
|
31,535
|
|
|
|
11,494
|
|
Deferred lease liability and other liabilities
|
|
|
46
|
|
|
|
82
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
89,796
|
|
|
|
40,814
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders deficit:
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value; authorized
1,000,000 shares; issued and outstanding-none
|
|
|
|
|
|
|
|
|
Common stock, $.01 par value; authorized
100,000,000 shares; issued 52,178,834 shares
(51,889,102 outstanding) in 2010 and 42,360,133 shares
(42,070,401 outstanding) in 2009
|
|
|
522
|
|
|
|
424
|
|
Additional paid-in capital
|
|
|
401,853
|
|
|
|
392,335
|
|
Accumulated deficit
|
|
|
(480,943
|
)
|
|
|
(424,034
|
)
|
Common stock held in treasury, at cost; 289,732 shares
|
|
|
(3,952
|
)
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit
|
|
|
(82,520
|
)
|
|
|
(35,227
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit
|
|
$
|
7,276
|
|
|
$
|
5,587
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements
58
EMISPHERE
TECHNOLOGIES, INC.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009 Restated
|
|
|
2008
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Revenue
|
|
$
|
100
|
|
|
$
|
92
|
|
|
$
|
251
|
|
Cost of goods sold
|
|
|
22
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
78
|
|
|
|
77
|
|
|
|
251
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,495
|
|
|
|
4,046
|
|
|
|
12,785
|
|
General and administrative
|
|
|
7,963
|
|
|
|
10,068
|
|
|
|
9,176
|
|
Gain on disposal of fixed assets
|
|
|
(1
|
)
|
|
|
(789
|
)
|
|
|
(135
|
)
|
Restructuring charge
|
|
|
50
|
|
|
|
(356
|
)
|
|
|
3,831
|
|
Depreciation and amortization
|
|
|
294
|
|
|
|
367
|
|
|
|
914
|
|
Contract termination expense
|
|
|
542
|
|
|
|
|
|
|
|
|
|
Expense from settlement of lawsuit
|
|
|
278
|
|
|
|
1,293
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
11,621
|
|
|
|
14,629
|
|
|
|
26,571
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(11,543
|
)
|
|
|
(14,552
|
)
|
|
|
(26,320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of patent
|
|
|
500
|
|
|
|
500
|
|
|
|
1,500
|
|
Sublease income
|
|
|
|
|
|
|
232
|
|
|
|
797
|
|
Investment and other income
|
|
|
252
|
|
|
|
131
|
|
|
|
371
|
|
Change in fair value of derivative instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(15,988
|
)
|
|
|
(1,853
|
)
|
|
|
1,085
|
|
Others
|
|
|
(7,663
|
)
|
|
|
(620
|
)
|
|
|
1,135
|
|
Interest expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(3,201
|
)
|
|
|
(82
|
)
|
|
|
(2,428
|
)
|
Others
|
|
|
(394
|
)
|
|
|
(577
|
)
|
|
|
(528
|
)
|
Loss on extinguishment of debt
|
|
|
(17,014
|
)
|
|
|
|
|
|
|
|
|
Financing fees
|
|
|
(1,858
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other non-operating income (expense)
|
|
|
(45,366
|
)
|
|
|
(2,269
|
)
|
|
|
1,932
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(56,909
|
)
|
|
$
|
(16,821
|
)
|
|
$
|
(24,388
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(1.23
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(0.80
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding, basic and diluted
|
|
|
46,206,803
|
|
|
|
34,679,321
|
|
|
|
30,337,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements
59
EMISPHERE
TECHNOLOGIES, INC.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009 Restated
|
|
|
2008
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(56,909
|
)
|
|
$
|
(16,821
|
)
|
|
$
|
(24,388
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
294
|
|
|
|
367
|
|
|
|
914
|
|
Non-cash interest expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
22,073
|
|
|
|
82
|
|
|
|
2,428
|
|
Others
|
|
|
394
|
|
|
|
577
|
|
|
|
528
|
|
Changes in the fair value of derivative instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
15,988
|
|
|
|
1,853
|
|
|
|
(1,085
|
)
|
Others
|
|
|
7,663
|
|
|
|
620
|
|
|
|
(1,135
|
)
|
Non-cash restructuring charge
|
|
|
|
|
|
|
|
|
|
|
1,040
|
|
Non-cash compensation
|
|
|
799
|
|
|
|
1,587
|
|
|
|
1,011
|
|
Gain on disposal of fixed assets
|
|
|
(1
|
)
|
|
|
(789
|
)
|
|
|
(135
|
)
|
Changes in assets and liabilities excluding non-cash charges:
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in accounts receivable
|
|
|
145
|
|
|
|
73
|
|
|
|
60
|
|
Increase in inventories
|
|
|
(24
|
)
|
|
|
(20
|
)
|
|
|
|
|
(Increase) decrease in prepaid expenses and other current assets
|
|
|
(344
|
)
|
|
|
(95
|
)
|
|
|
710
|
|
Increase (decrease) in accounts payable, accrued expenses and
other
|
|
|
(1,554
|
)
|
|
|
2,613
|
|
|
|
(513
|
)
|
Increase in deferred revenue
|
|
|
7,072
|
|
|
|
166
|
|
|
|
11,254
|
|
Decrease in deferred lease and other liabilities
|
|
|
(35
|
)
|
|
|
(14
|
)
|
|
|
(253
|
)
|
Increase (decrease) in restructuring charge
|
|
|
(450
|
)
|
|
|
(2,130
|
)
|
|
|
2,880
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
52,020
|
|
|
|
4,890
|
|
|
|
17,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(4,889
|
)
|
|
|
(11,931
|
)
|
|
|
(6,684
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale and maturity of investments
|
|
|
|
|
|
|
|
|
|
|
9,927
|
|
Equipment purchases
|
|
|
|
|
|
|
|
|
|
|
(109
|
)
|
Increase in restricted cash
|
|
|
(1
|
)
|
|
|
(4
|
)
|
|
|
(9
|
)
|
Proceeds from sale of fixed assets
|
|
|
1
|
|
|
|
989
|
|
|
|
138
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
|
|
|
|
985
|
|
|
|
9,947
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from notes payable
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Payments on notes payable
|
|
|
(525
|
)
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and warrants
|
|
|
|
|
|
|
|
|
|
|
13
|
|
Net proceeds from issuance of common stock and warrants
|
|
|
6,674
|
|
|
|
7,298
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
6,649
|
|
|
|
7,298
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
1,760
|
|
|
|
(3,648
|
)
|
|
|
3,276
|
|
Cash and cash equivalents, beginning of year
|
|
|
3,566
|
|
|
|
7,214
|
|
|
|
3,938
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of year
|
|
$
|
5,326
|
|
|
$
|
3,566
|
|
|
$
|
7,214
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
6
|
|
|
$
|
|
|
|
$
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of liability warrants in connection with common stock
offering
|
|
$
|
4,920
|
|
|
$
|
4,523
|
|
|
$
|
|
|
Exchange of debt as deferred revenue (Note 8 )
|
|
$
|
13,000
|
|
|
$
|
|
|
|
$
|
|
|
Common stock issued to settle accrued directors
compensation
|
|
$
|
10
|
|
|
$
|
|
|
|
$
|
|
|
The accompanying notes are an integral part of the financial
statements
60
EMISPHERE
TECHNOLOGIES, INC.
For the years ended December 31, 2010,
2009 and 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Comprehensive
|
|
|
Common Stock
|
|
|
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
(Loss)
|
|
|
Held in Treasury
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Income
|
|
|
Shares
|
|
|
Amount
|
|
|
Total
|
|
|
|
(In thousands, except share data)
|
|
|
Balance, December 31, 2007
|
|
|
30,626,660
|
|
|
$
|
306
|
|
|
$
|
399,282
|
|
|
$
|
(409,300
|
)
|
|
$
|
(10
|
)
|
|
|
289,732
|
|
|
$
|
(3,952
|
)
|
|
$
|
(13,674
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,388
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,388
|
)
|
Unrealized loss on investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(24,378
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock under exercise of options
|
|
|
4,150
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
Stock based compensation expense for employees
|
|
|
|
|
|
|
|
|
|
|
1,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2008
|
|
|
30,630,810
|
|
|
|
306
|
|
|
|
400,306
|
|
|
|
(433,688
|
)
|
|
|
|
|
|
|
289,732
|
|
|
|
(3,952
|
)
|
|
|
(37,028
|
)
|
Net loss (as restated)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,821
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,821
|
)
|
Cumulative effect of change in accounting principle
implementation of
ASC 815-40-15-5
restated
|
|
|
|
|
|
|
|
|
|
|
(12,215
|
)
|
|
|
26,475
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,260
|
|
Equity proceeds from issuance of common stock, net of share
issuance expenses
|
|
|
11,729,323
|
|
|
|
118
|
|
|
|
2,657
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,775
|
|
Stock based compensation expense for employees
|
|
|
|
|
|
|
|
|
|
|
1,532
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,532
|
|
Stock based compensation expense for directors
|
|
|
|
|
|
|
|
|
|
|
55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2009
|
|
|
42,360,133
|
|
|
|
424
|
|
|
|
392,335
|
|
|
|
(424,034
|
)
|
|
|
|
|
|
|
289,732
|
|
|
|
(3,952
|
)
|
|
|
(35,227
|
)
|
(as restated)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(56,909
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(56,909
|
)
|
Issuance of common stock to directors
|
|
|
13,674
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
Reclassification of derivative liability due to exercise of
warrants
|
|
|
|
|
|
|
|
|
|
|
7,053
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,053
|
|
Exercise of warrants
|
|
|
2,809,971
|
|
|
|
28
|
|
|
|
(28
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity proceeds from issuance of common stock, net of share
issuance expenses
|
|
|
6,995,056
|
|
|
|
70
|
|
|
|
1,684
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,754
|
|
Stock based compensation expense for employees
|
|
|
|
|
|
|
|
|
|
|
723
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
723
|
|
Stock based compensation expense for directors
|
|
|
|
|
|
|
|
|
|
|
76
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2010
|
|
|
52,178,834
|
|
|
$
|
522
|
|
|
$
|
401,853
|
|
|
$
|
(480,943
|
)
|
|
|
|
|
|
|
289,732
|
|
|
$
|
(3,952
|
)
|
|
$
|
(82,520
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements
61
EMISPHERE
TECHNOLOGIES, INC.
|
|
1.
|
Nature of
Operations, Risks and Uncertainties and Liquidity
|
Nature of Operations. Emisphere Technologies,
Inc. (Emisphere, our, us,
the company or we) is a
biopharmaceutical company that focuses on our improved delivery
of therapeutic molecules and pharmaceutical compounds using its
Eligen®
Technology. These molecules and compounds could be currently
available or are in pre-clinical or clinical development.
Our core business strategy is to develop oral forms of drugs
that are not currently available or have poor bioavailability in
oral form, either alone or with corporate partners, by applying
the
Eligen®
Technology to those drugs. Typically, the drugs that we target
have received regulatory approval, have demonstrated safety and
efficacy, and are currently available on the market.
Risks and Uncertainties. We have no
prescription products currently approved for sale by the
U.S. FDA. There can be no assurance that our research and
development will be successfully completed, that any products
developed will obtain necessary government regulatory approval
or that any approved products will be commercially viable. In
addition, we operate in an environment of rapid change in
technology and are dependent upon the continued services of our
current employees, consultants and subcontractors.
Liquidity. As of December 31, 2010, we
had approximately $5.6 million in cash and restricted cash,
approximately $20.6 million in working capital deficiency,
a stockholders deficit of approximately $82.5 million
and an accumulated deficit of approximately $480.9 million.
Our net loss and operating loss for the year ended
December 31, 2010 was approximately $56.9 million and
$11.5 million, respectively. Since our inception in 1986,
we have generated significant losses from operations. We have
limited capital resources and operations to date have been
funded primarily with the proceeds from collaborative research
agreements, public and private equity and debt financings and
income earned on investments. We anticipate that we will
continue to generate significant losses from operations for the
foreseeable future, and that our business will require
substantial additional investment that we have not yet secured.
As such, we anticipate that our existing capital resources,
without implementing cost reductions, raising additional
capital, or obtaining substantial cash inflows from potential
partners for our products, will enable us to continue operations
through approximately June 2011 or earlier if unforeseen events
arise that negatively affect our liquidity. Further, we have
significant future commitments and obligations. These conditions
raise substantial doubt about our ability to continue as a going
concern.
Our plan is to raise capital when needed
and/or to
pursue product partnering opportunities. We expect to continue
to spend substantial amounts on research and development,
including amounts spent on conducting clinical trials for our
product candidates. Expenses will be partially offset with
income-generating license agreements, if possible. Further, we
will not have sufficient resources to develop fully any new
products or technologies unless we are able to raise substantial
additional financing on acceptable terms or secure funds from
new or existing partners. We cannot assure that financing will
be available when needed, or on favorable terms or at all. If
additional capital is raised through the sale of equity or
convertible debt securities, the issuance of such securities
would result in dilution to our existing stockholders. Our
failure to raise capital before June 2011 will adversely affect
our business, financial condition and results of operations, and
could force us to reduce or cease our operations. No adjustment
has been made in the accompanying financial statements to the
carrying amount and classification of recorded assets and
liabilities should we be unable to continue operations.
|
|
2.
|
Summary
of Significant Accounting Policies
|
Use of Estimates. The preparation of financial
statements in accordance with accounting principles generally
accepted in the U.S. involves the use of estimates and
assumptions that affect the recorded amounts of assets and
liabilities as of the date of the financial statements and the
reported amounts of revenue and expenses and performance period
for revenue recognition. Actual results may differ substantially
from these
62
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
estimates. Significant estimates include the fair value and
recoverability of the carrying value of purchased technology,
recognition of on-going clinical trial costs, estimated costs to
complete research collaboration projects, accrued expenses, the
variables and method used to calculate stock-based compensation,
derivative instruments and deferred taxes.
Concentration of Credit Risk. Financial
instruments, which potentially subject us to concentrations of
credit risk, consist of cash, cash equivalents, restricted cash
and investments. We invest excess funds in accordance with a
policy objective seeking to preserve both liquidity and safety
of principal. We generally invest our excess funds in
obligations of the U.S. government and its agencies, bank
deposits, money market funds, and investment grade debt
securities issued by corporations and financial institutions. We
hold no collateral for these financial instruments.
Cash, Cash Equivalents, and Investments. We
consider all highly liquid, interest-bearing instruments with
original maturity of three months or less when purchased to be
cash equivalents. Cash and cash equivalents may include demand
deposits held in banks and interest bearing money market funds.
Our investment policy requires that commercial paper be rated
A-1,
P-1 or
better by either Standard and Poors Corporation or
Moodys Investor Services or another nationally recognized
agency and that securities of issuers with a long-term credit
rating must be rated at least A (or equivalent). As
of December 31, 2010, we held no investments.
Inventory. Inventories are stated at the lower
of cost or market determined by the first in, first out method.
Equipment and Leasehold
Improvements. Equipment and leasehold
improvements are stated at cost. Depreciation and amortization
are provided on a straight-line basis over the estimated useful
life of the asset. Leasehold improvements are amortized over the
term of the lease or useful life of the improvements, whichever
is shorter. Expenditures for maintenance and repairs that do not
materially extend the useful lives of the respective assets are
charged to expense as incurred. The cost and accumulated
depreciation or amortization of assets retired or sold are
removed from the respective accounts and any gain or loss is
recognized in operations.
Purchased Technology. Purchased technology
represents the value assigned to patents and the right to use,
sell or license certain technology in conjunction with our
proprietary carrier technology that were acquired from Ebbisham
Ltd. These assets are utilized in various research and
development projects. Such purchased technology is being
amortized on a straight line basis over 15 years, until
2014, which represents the average life of the patents acquired.
Impairment of Long-Lived Assets. In accordance
with FASB
ASC 360-10-35,
we review our long-lived assets, including purchased technology,
for impairment whenever events and circumstances indicate that
the carrying value of an asset might not be recoverable. An
impairment loss, measured as the amount by which the carrying
value exceeds the fair value, is recognized if the carrying
amount exceeds estimated undiscounted future cash flows.
Deferred Lease Liability. Our leases provide
for rental holidays and escalations of the minimum rent during
the lease term, as well as additional rent based upon increases
in real estate taxes and common maintenance charges. We record
rent expense from leases with rental holidays and escalations
using the straight-line method, thereby prorating the total
rental commitment over the term of the lease. Under this method,
the deferred lease liability represents the difference between
the minimum cash rental payments and the rent expense computed
on a straight-line basis.
Revenue Recognition. We recognize revenue in
accordance with FASB
ASC 605-10-S99,
Revenue Recognition. Revenue includes amounts
earned from sales of our oral
Eligen®
B12 (100 mcg) product, collaborative agreements and feasibility
studies. Revenue earned from the sale of oral
Eligen®
B12 (100 mcg)
63
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
was recognized when the product was shipped, when all revenue
recognition criteria were met in accordance with Staff
Accounting Bulletin No. 104 , Revenue
Recognition (codified under ASC 605 Revenue
Recognition). Our distributor agreement for the marketing,
distribution and sale of oral
Eligen®
B12 (100 mcg) with Quality Vitamins and Supplements, Inc. was
terminated during the third quarter, 2010. Revenue earned from
collaborative agreements and feasibility studies is comprised of
reimbursed research and development costs, as well as upfront
and research and development milestone payments. Deferred
revenue represents payments received which are related to future
performance. Revenue from feasibility studies, which are
typically short term in nature, is recognized upon delivery of
the study, provided that all other revenue recognition criteria
are met.
Revenue from collaboration agreements are recognized using the
proportional performance method provided that we can reasonably
estimate the level of effort required to complete our
performance obligations under an arrangement and such
performance obligations are provided on a best effort basis and
based on expected payments. Under the proportional
performance method, periodic revenue related to nonrefundable
cash payments is recognized as the percentage of actual effort
expended to date as of that period to the total effort expected
for all of our performance obligations under the arrangement.
Actual effort is generally determined based upon actual hours
incurred and include R&D activities performed by us and
time spent for JSC activities. Total expected effort is
generally based upon the total R&D and JSC hours
incorporated into the project plan that is agreed to by both
parties to the collaboration. Significant management judgments
and estimates are required in determining the level of effort
required under an arrangement and the period over which we
expect to complete the related performance obligations.
Estimates of the total expected effort included in each project
plan are based on historical experience of similar efforts and
expectations based on the knowledge of scientists for both the
Company and its collaboration partners. The Company periodically
reviews and updates the project plan for each collaborative
agreement. The most recent reviews took place in January 2011.
In the event that a change in estimate occurs, the change will
be accounted for using the cumulative
catch-up
method which provides for an adjustment to revenue in the
current period. Estimates of our level of effort may change in
the future, resulting in a material change in the amount of
revenue recognized in future periods.
Generally under collaboration arrangements, nonrefundable
payments received during the period of performance may include
time- or performance-based milestones. The proportion of actual
performance to total expected performance is applied to the
expected payments in determining periodic revenue.
However, revenue is limited to the sum of (i) the amount of
nonrefundable cash payments received and (ii) the payments
that are contractually due but have not yet been paid.
With regard to revenue recognition in connection with
development and license agreements that include multiple
deliverables; Emispheres management reviews the relevant
terms of the agreements and determines whether such deliverables
should be accounted for as a single unit of accounting in
accordance with FASB
ASC 605-25,
Multiple-Element Arrangements. If it is determined that a
delivered license and
Eligen®
Technology do not have stand-alone value and Emisphere does not
have objective evidence of fair value of the undelivered
Eligen®
Technology or the manufacturing value of all the undelivered
items, then such deliverables are accounted for as a single unit
of accounting and any payments received pursuant to such
agreement, including any upfront or development milestone
payments and any payments received for support services, will be
deferred and included in deferred revenue within our balance
sheet until such time as management can estimate when all of
such deliverables will be delivered, if ever. Management reviews
and reevaluates such conclusions as each item in the arrangement
is delivered and circumstances of the development arrangement
change. See Note 13 for more information about the
Companys accounting for revenue from specific development
and license agreements.
Research and Development and Clinical Trial
Expenses. Research and development expenses
include costs directly attributable to the conduct of research
and development programs, including the cost of salaries,
64
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
payroll taxes, employee benefits, materials, supplies,
maintenance of research equipment, costs related to research
collaboration and licensing agreements, the cost of services
provided by outside contractors, including services related to
our clinical trials, clinical trial expenses, the full cost of
manufacturing drug for use in research, pre-clinical
development, and clinical trials. All costs associated with
research and development are expensed as incurred.
Clinical research expenses represent obligations resulting from
our contracts with various research organizations in connection
with conducting clinical trials for our product candidates. We
account for those expenses on an accrual basis according to the
progress of the trial as measured by patient enrollment and the
timing of the various aspects of the trial. Accruals are
recorded in accordance with the following methodology:
(i) the costs for period expenses, such as investigator
meetings and initial
start-up
costs, are expensed as incurred based on managements
estimates, which are impacted by any change in the number of
sites, number of patients and patient start dates;
(ii) direct service costs, which are primarily ongoing
monitoring costs, are recognized on a straight-line basis over
the life of the contract; and (iii) principal investigator
expenses that are directly associated with recruitment are
recognized based on actual patient recruitment. All changes to
the contract amounts due to change orders are analyzed and
recognized in accordance with the above methodology. Change
orders are triggered by changes in the scope, time to completion
and the number of sites. During the course of a trial, we adjust
our rate of clinical expense recognition if actual results
differ from our estimates.
Income Taxes. Deferred tax liabilities and
assets are recognized for the expected future tax consequences
of events that have been included in the financial statements or
tax returns. These liabilities and assets are determined based
on differences between the financial reporting and tax basis of
assets and liabilities measured using the enacted tax rates and
laws that will be in effect when the differences are expected to
reverse. A valuation allowance is recognized to reduce deferred
tax assets to the amount that is more likely than not to be
realized. In assessing the likelihood of realization, management
considered estimates of future taxable income.
Stock-Based Employee Compensation. We
recognize expense for our share-based compensation based on the
fair value of the awards at the time they are granted. We
estimate the value of stock option awards on the date of grant
using the Black-Scholes model. The determination of the fair
value of share-based payment awards on the date of grant is
affected by our stock price as well as assumptions regarding a
number of complex and subjective variables. These variables
include our expected stock price volatility over the term of the
awards, expected term, risk-free interest rate, expected
dividends and expected forfeiture rates. The forfeiture rate is
estimated using historical option cancellation information,
adjusted for anticipated changes in expected exercise and
employment termination behavior. Our outstanding awards do not
contain market or performance conditions therefore we have
elected to recognize share-based employee compensation expense
on a straight-line basis over the requisite service period.
Fair Value of Financial Instruments. The
carrying amounts for cash, cash equivalents, accounts payable,
and accrued expenses approximate fair value because of their
short-term nature. We estimated the fair value of the MHR
Convertible Notes, which are due on September 26, 2012 as
of June 4, 2010 when the MHR Convertible Notes were
restructured to account for incremental compensation in
connection with the Novartis Agreement by calculating the
present value of future cash flows discounted at a market rate
of return for a comparable debt instrument. At December 31,
2010, the carrying value of the notes payable and accrued
interest was $19.9 million. See Note 8 for further
discussion of the notes payable.
Derivative Instruments. Derivative instruments
consist of common stock warrants, and certain instruments
embedded in the certain Notes payable and related agreements.
These financial instruments are recorded in the balance sheets
at fair value as liabilities. Changes in fair value are
recognized in earnings in the period of change.
65
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
Effective January 1, 2009, the Company adopted the
provisions of the Financial Accounting Standards Board
Accounting Codification Topic
815-40-15-5,
Evaluating Whether an Instrument Involving a Contingency is
Considered Indexed to an Entitys Own Stock (FASB
ASC 815-40-15-5).
FASB
ASC 815-40-15-5
provides guidance in assessing whether an equity-linked
financial instrument (or embedded feature) is indexed to an
entitys own stock for purposes of determining whether the
equity linked instrument (or embedded feature) qualifies as a
derivative instrument. We determined that the conversion feature
of our MHR Convertible Notes and certain of our warrants contain
features that that are not indexed to our own stock and
therefore, were classified as a derivative instrument. Upon
adoption, we recognized and recorded a cumulative effect of a
change in accounting principle of $26.5 million. The
cumulative adjustment included a decrease in Notes payable of
approximately $18.2 million, a decrease in deferred
financing fees of approximately $0.4 million, an increase
in derivative instruments of approximately $3.5 million and
the balance was a reduction in stockholders deficit.
For comparability purposes, the following table sets forth the
effects of the adoption of FASB
ASC 815-40-15-5
on net loss and loss per share for the year ended
December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
As Reported
|
|
|
Pro Forma (unaudited)
|
|
|
|
December 31, 2008
|
|
|
December 31, 2008
|
|
|
|
(In thousands, except per
|
|
|
(In thousands, except
|
|
|
|
share amounts)
|
|
|
per share amounts)
|
|
|
Net loss
|
|
$
|
(24,388
|
)
|
|
$
|
(16,465
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic
|
|
$
|
(0.80
|
)
|
|
$
|
(0.54
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, dilutive
|
|
$
|
(0.80
|
)
|
|
$
|
(0.54
|
)
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss. Comprehensive loss
represents the change in net assets of a business enterprise
during a period from transactions and other events and
circumstances from non-owner sources. Comprehensive loss
includes net loss adjusted for the change in net unrealized gain
or loss on marketable securities. The disclosures required by
FASB
ASC 220-10-45,
Reporting Comprehensive Income for the year ended
December 31, 2008 has been included in the statements of
stockholders equity (deficit). There are no differences
between comprehensive loss and net loss for the years ended
December 31, 2010 and 2009.
Exit activities. We have adopted FASB
ASC 420-10-05,
Exit or Disposal Cost Obligations. This
Standard addresses financial accounting and reporting for costs
associated with exit or disposal activities. This Standard
requires that a liability for a cost associated with an exit or
disposal activity be recognized when the liability is incurred.
This Standard also establishes that fair value is the objective
for initial measurement of the liability. This Standard
specifies that a liability for a cost associated with an exit or
disposal activity is incurred when the definition of a liability
is met, and that fair value is the measurement at the exit,
disposal or cease use date.
Fair Value Measurements. The authoritative
guidance for fair value measurements defines fair value as the
exchange price that would be received an asset or paid to
transfer a liability (an exit price) in the principal or the
most advantageous market for the asset or liability in an
orderly transaction between market participants on the
measurement date. Market participants are buyers and sellers in
the principal market that are (i) independent,
(ii) knowledgeable, (iii) able to transact, and
(iv) willing to transact. The guidance describes a fair
value hierarchy based on the levels of inputs, of which the
first two are considered observable and the last unobservable,
that may be used to measure fair value which are the following:
|
|
|
|
|
Level 1 Quoted prices in active markets for
identical assets or liabilities
|
|
|
|
Level 2 Inputs other than Level 1 that are
observable, either directly or indirectly, such as quoted prices
for similar assets or liabilities; quoted prices in markets that
are not active; or other inputs that
|
66
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
are observable or corroborated by observable market data or
substantially the full term of the assets or liabilities
|
|
|
|
|
|
Level 3 Unobservable inputs that are supported
by little or no market activity and that are significant to the
value of the assets or liabilities
|
Future
Impact of Recently Issued Accounting Standards
In December 2010, the Financial Accounting Standards Board
(FASB) issued Accounting Standards Update (ASU)
2010-29,
Business Combinations (ASC Topic 805): Disclosure of
Supplementary Pro Forma Information for Business
Combinations. The amendments in this ASU affect any public
entity as defined by ASC Topic 805 that enters into business
combinations that are material on an individual or aggregate
basis. The amendments in this ASU specify that if a public
entity presents comparative financial statements, the entity
should disclose revenue and earnings of the combined entity as
though the business combination(s) that occurred during the
current year had occurred as of the beginning of the comparable
prior annual reporting period only. The amendments also expand
the supplemental pro forma disclosures to include a description
of the nature and amount of material, nonrecurring pro forma
adjustments directly attributable to the business combination
included in the reported pro forma revenue and earnings. The
amendments are effective prospectively for business combinations
for which the acquisition date is on or after the beginning of
the first annual reporting period beginning on or after
December 15, 2010. Early adoption is permitted. The Company
does not expect adoption of ASU
2010-29 to
have a material impact on the Companys results of
operations or financial condition.
In December 2010, the FASB issued ASU
2010-28,
Intangibles Goodwill and Other (ASC Topic
350): When to Perform Step 2 of the Goodwill Impairment Test for
Reporting Units with Zero or Negative Carrying Amounts.
The amendments in this ASU modify Step 1 of the goodwill
impairment test for reporting units with zero or negative
carrying amounts. For those reporting units, an entity is
required to perform Step 2 of the goodwill impairment test if it
is more likely than not that a goodwill impairment exists. In
determining whether it is more likely than not that a goodwill
impairment exists, an entity should consider whether there are
any adverse qualitative factors indicating that an impairment
may exist. The qualitative factors are consistent with the
existing guidance and examples, which require that goodwill of a
reporting unit be tested for impairment between annual tests if
an event occurs or circumstances change that would more likely
than not reduce the fair value of a reporting unit below its
carrying amount. For public entities, the amendments in this ASU
are effective for fiscal years, and interim periods within those
years, beginning after December 15, 2010. Early adoption is
not permitted. The Company does not expect the adoption of ASU
2010-28 to
have a material impact on the Companys results of
operations or financial condition.
In April 2010, the FASB issued ASU
2010-17,
Revenue Recognition Milestone Method
(ASU
2010-17).
ASU 2010-17
provides guidance on the criteria that should be met for
determining whether the milestone method of revenue recognition
is appropriate. A vendor can recognize consideration that is
contingent upon achievement of a milestone in its entirety as
revenue in the period in which the milestone is achieved only if
the milestone meets all criteria to be considered substantive.
The following criteria must be met for a milestone to be
considered substantive. The consideration earned by achieving
the milestone should (i) be commensurate with either the
level of effort required to achieve the milestone or the
enhancement of the value of the item delivered as a result of a
specific outcome resulting from the vendors performance to
achieve the milestone; (ii) be related solely to past
performance; and (iii) be reasonable relative to all
deliverables and payment terms in the arrangement. No
bifurcation of an individual milestone is allowed and there can
be more than one milestone in an arrangement. Accordingly, an
arrangement may contain both substantive and non-substantive
milestones. ASU
2010-17 is
effective on a prospective basis for milestones achieved in
fiscal years, and interim periods within those years, beginning
on or after June 15, 2010.
67
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
Management evaluated the potential impact of ASU
2010-17 and
does not expect its adoption to have a material effect on the
Companys results of operations or financial condition.
In January 2010, the FASB issued ASU
2010-06,
Improving Disclosures about Fair Value Measurements. ASU
2010-06
amends ASC 820 to require a number of additional
disclosures regarding fair value measurements. The amended
guidance requires entities to disclose the amounts of
significant transfers between Level 1 and Level 2 of
the fair value hierarchy and the reasons for these transfers,
the reasons for any transfers in or out of Level 3, and
information in the reconciliation of recurring Level 3
measurements about purchases, sales, issuances and settlements
on a gross basis. The ASU also clarifies the requirements for
entities to disclose information about both the valuation
techniques and inputs used in estimating Level 2 and
Level 3 fair value measurements. The amended guidance is
effective for interim and annual financial periods beginning
after December 15, 2009. The adoption of ASU
2010-06 did
not have a significant effect on the Companys financial
statements.
In October 2009, the FASB issued ASU
2009-13,
Multiple-Deliverable Revenue Arrangements, (amendments to
FASB ASC Topic 605, Revenue Recognition ) (ASU
2009-13).
ASU 2009-13
requires entities to allocate revenue in an arrangement using
estimated selling prices of the delivered goods and services
based on a selling price hierarchy. The amendments eliminate the
residual method of revenue allocation and require revenue to be
allocated using the relative selling price method. ASU
2009-13
should be applied on a prospective basis for revenue
arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010, with early adoption
permitted. The Company does not expect adoption of ASU
2009-13 to
have a material impact on the Companys results of
operations or financial condition.
In October 2009, the FASB issued ASU
2009-15,
Accounting for Own-Share Lending Arrangements in
Contemplation of Convertible Debt Issuance or Other
Financing, (ASU-2009-15), which provides
guidance for accounting and reporting for own-share lending
arrangements issued in contemplation of a convertible debt
issuance. At the date of issuance, a share-lending arrangement
entered into on an entitys own shares should be measured
at fair value in accordance with Topic 820 and recognized as an
issuance cost, with an offset to additional paid-in capital.
Loaned shares are excluded from basic and diluted earnings per
share unless default of the share-lending arrangement occurs.
The amendments also require several disclosures including a
description and the terms of the arrangement and the reason for
entering into the arrangement. The effective dates of the
amendments are dependent upon the date the share-lending
arrangement was entered into and include retrospective
application for arrangements outstanding as of the beginning of
fiscal years beginning on or after December 15, 2009. The
adoption of ASU
209-15 did
not have a material impact on the Companys results of
operations or financial condition.
Management does not believe that any other recently issued, but
not yet effective, accounting standards if currently adopted
would have a material effect on the accompanying financial
statements.
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Work in process
|
|
$
|
260
|
|
|
$
|
5
|
|
Finished goods
|
|
|
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
260
|
|
|
$
|
20
|
|
|
|
|
|
|
|
|
|
|
68
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
4.
|
Prepaid
Expenses and Other Current Assets
|
Prepaid expenses and other current assets consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Prepaid corporate insurance
|
|
$
|
41
|
|
|
$
|
44
|
|
Deposit on inventory
|
|
|
420
|
|
|
|
215
|
|
Prepaid expenses and other current assets
|
|
|
35
|
|
|
|
110
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
496
|
|
|
$
|
369
|
|
|
|
|
|
|
|
|
|
|
Tarrytown Facility. On December 8, 2008,
we decided to close our research and development facilities in
Tarrytown, NY to reduce costs and improve operating efficiency.
As of December 8, 2008 we ceased using approximately 85% of
the facilities which resulted in a restructuring charge of
approximately $3.8 million in the fourth quarter, 2008. As
a result, the Company wrote down the value of approximately
$1.0 million (net) in leasehold improvements related to the
Tarrytown facility no longer in use as of December 31,
2008. In addition, the useful lives of approximately
$0.2 million in leasehold improvements were shortened
because we ceased using the facilities on January 29, 2009
resulting in an accelerated charge to amortization expense for
2008 of approximately $0.1 million. Please refer to
Footnote 16 Commitments and Contingencies for more
information on this subject.
Fixed Assets. Equipment and leasehold
improvements, net, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
Useful Lives In Years
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Equipment
|
|
3-7
|
|
$
|
1,370
|
|
|
$
|
1,370
|
|
Leasehold improvements
|
|
Term of lease
|
|
|
61
|
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,431
|
|
|
|
1,431
|
|
Less, accumulated depreciation and amortization
|
|
|
|
|
1,349
|
|
|
|
1,293
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
82
|
|
|
$
|
138
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2010,
2009 and 2008, was $0.1 million, $0.1 million and
$0.7 million, respectively.
In 2009, in connection with the closure of our Tarrytown
facility, we abandoned leasehold improvements with a historical
cost of $2.95 million and accumulated amortization of
$2.85 million. We also abandoned equipment with a
historical cost of $2.86 million and accumulated
depreciation of $2.84. Additionally, during 2009, we sold
equipment with a historical cost of $4.84 million and
accumulated depreciation of $4.76 million for
$0.99 million. The effect of these abandonments and sales
was a gain of $0.79 million.
69
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
The carrying value of the purchased technology is comprised as
follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Gross carrying amount
|
|
$
|
4,533
|
|
|
$
|
4,533
|
|
Less, accumulated amortization
|
|
|
3,695
|
|
|
|
3,456
|
|
|
|
|
|
|
|
|
|
|
Net book value
|
|
$
|
838
|
|
|
$
|
1,077
|
|
|
|
|
|
|
|
|
|
|
Annual amortization of purchased technology was
$0.2 million for 2010, 2009 and 2008 and is estimated to be
$0.2 million for the years ended 2011 through 2013 and
$0.1 million in 2014.
|
|
7.
|
Accounts
Payable and Accrued Expenses
|
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Accounts payable
|
|
$
|
2,201
|
|
|
$
|
1,979
|
|
Accrued cost of lawsuit
|
|
|
|
|
|
|
2,333
|
|
Accrued bonus
|
|
|
300
|
|
|
|
150
|
|
Accrued legal, professional fees and other
|
|
|
375
|
|
|
|
302
|
|
Accrued vacation
|
|
|
69
|
|
|
|
81
|
|
Clinical trial expenses and contract research
|
|
|
9
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,954
|
|
|
$
|
4,975
|
|
|
|
|
|
|
|
|
|
|
|
|
8.
|
Notes
Payable and Restructuring of Debt
|
Notes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2009
|
|
|
|
2010
|
|
|
restated
|
|
|
|
(In thousands)
|
|
|
MHR Convertible Note
|
|
$
|
19,864
|
|
|
$
|
93
|
|
MHR Promissory Notes
|
|
|
520
|
|
|
|
|
|
Novartis Note
|
|
|
|
|
|
|
12,588
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
20,385
|
|
|
$
|
12,681
|
|
|
|
|
|
|
|
|
|
|
MHR Convertible Notes. On September 26,
2005, we received net proceeds of approximately
$12.9 million under a $15 million secured loan
agreement (the Loan Agreement) executed with MHR.
Under the Loan Agreement, MHR requested, and on May 16,
2006, we effected, the exchange of the loan from MHR for senior
secured convertible notes (the MHR Convertible
Notes) with substantially the same terms as the Loan
Agreement, except that the MHR Convertible Notes are
convertible, at the sole discretion of MHR, into shares of our
common stock at a price per share of $3.78. As of
December 31, 2010, the MHR Convertible Notes were
convertible into 6,675,512 shares of our common stock. The
MHR Convertible Notes are due on September 26, 2012, bear
interest at 11% and are collateralized by a first priority lien
in favor of MHR on
70
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
substantially all of our assets. Interest is payable in the form
of additional MHR Convertible Notes rather than in cash.
In connection with the Loan Agreement, we amended MHRs
previously existing warrants to purchase 387,374 shares of
common stock (MHR 2005 Warrants) to provide
additional anti-dilution protection. We also granted MHR the
option (MHR Option) to purchase warrants for up to
617,211 shares of our common stock. The MHR Option was
exercised during April 2006 whereby MHR acquired 617,211
warrants (MHR 2006 Warrants) to acquire an equal
number of shares of common stock. The exercise price for the MHR
Option was $0.01 per warrant for the first 67,084 warrants and
$1.00 per warrant for each additional warrant. See Note 9
for a further discussion of the liability related to these
warrants.
Total issuance costs associated with the Loan Agreement were
$2.1 million, of which $1.9 million were allocated to
the MHR Convertible Note and $0.2 million were allocated to
the related derivative instruments. Of the $1.9 million
allocated to the MHR Convertible Note, $1.4 million
represents reimbursement of MHRs legal fees and
$0.5 million represents our legal and other transaction
costs. The $1.4 million paid on behalf of the lender has
been recorded as a reduction of the face value of the note,
while the $0.5 million of our costs has been recorded as
deferred financing costs, which is included in other assets on
the balance sheet.
The MHR Convertible Notes provide MHR with the right to require
us to redeem the notes in the event of a change in control. The
change in control redemption feature has been determined to be
an embedded derivative instrument which must be separated from
the host contract. For the year ended December 31, 2006,
the fair value of the change in control redemption feature was
estimated using a combination of a put option model for the
penalties and the Black-Scholes model for the conversion option
that would exist under the MHR Convertible Note. The estimate
resulted in a value that was de minimis and, therefore, no
separate liability was recorded. Changes in the assumptions used
to estimate the fair value of this derivative instrument, in
particular the probability that a change in control will occur,
could result in a material change to the fair value of the
instrument. For the years ended December 31, 2010, 2009 and
2008, management determined the probability of exercise of the
right due to change in control to be remote. The fair value of
the change in control redemption feature is de minimis.
In connection with the MHR Convertible Notes financing, the
Company agreed to appoint a representative of MHR (MHR
Nominee) and another person (the Mutual
Director) to its Board of Directors. Further, the Company
agreed to amend, and in January 2006 did amend, its certificate
of incorporation to provide for continuity of the MHR Nominee
and the Mutual Nominee on the Board, as described therein, so
long as MHR holds at least 2% of the outstanding common stock of
the Company.
The MHR Convertible Notes provide for various events of default
including for failure to perfect any of the liens in favor of
MHR, failure to observe any covenant or agreement, failure to
maintain the listing and trading of our common stock, sale of a
substantial portion of our assets, merger with another entity
without the prior consent of MHR, or any governmental action
renders us unable to honor or perform our obligations under the
Loan Agreement or results in a material adverse effect on our
operations. If an event of default occurs, the MHR Convertible
Notes provide for the immediate repayment and certain additional
amounts as set forth in the MHR Convertible Notes. We currently
have a waiver from MHR for failure to perfect liens on certain
intellectual property rights through March 19, 2012.
Effective January 1, 2009, the Company adopted the
provisions of the Financial Accounting Standards Board
Accounting Codification Topic
815-40-15-5,
Evaluating Whether an Instrument Involving a Contingency is
Considered Indexed to an Entitys Own Stock (FASB
ASC 815-40-15-5).
Under FASB
ASC 815-40-15-5,
the conversion feature embedded in the MHR Convertible Notes
have been bifurcated from the host contract and accounted for
separately as a derivative. The bifurcation of the embedded
derivative increased the amount of debt discount thereby
reducing the book value of the MHR Convertible Notes and
increasing prospectively the amount of interest expense to be
recognized over the life of the MHR Convertible Notes using the
effective
71
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
yield method. At December 31, 2010, the MHR Convertible
Notes were convertible into 6,675,512 shares of our common
stock.
As consideration for its consent and limitation of rights in
connection with the Novartis Agreement (as defined below), the
Company granted MHR warrants to purchase 865,000 shares of
its common stock (the June 2010 MHR Warrants) under
the MHR Letter Agreement. The Company estimated the fair value
of the June 2010 MHR Warrants on the date of grant using
Black-Scholes models to be $1.9 million. The Company
determined that the resulting modification of the MHR
Convertible Notes was substantial in accordance with
ASC 470-50,
Modifications and Extinguishments. As such
the modification of the MHR Convertible Notes was accounted for
as an extinguishment and restructuring of the debt, and the
warrants issued to MHR were expensed as a financing fee. The
fair value of the MHR Convertible Notes, as of June 4, 2010
was estimated by calculating the present value of future cash
flows discounted at a market rate of return for comparable debt
instruments to be $17.2 million. The Company recognized a
loss on extinguishment of debt in the amount of
$17.0 million which represented the difference between the
net carrying amount of the MHR Convertible Notes and their fair
value as of the date of the Novartis Agreement and the MHR
Letter Agreements.
The book value of the MHR Convertible Notes is comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2009
|
|
|
|
2010
|
|
|
restated
|
|
|
|
(In thousands)
|
|
|
Face value of the note (including accrued interest)
|
|
$
|
25,233
|
|
|
$
|
22,616
|
|
Discount (related to the warrant purchase option and embedded
conversion feature)
|
|
|
(5,369
|
)
|
|
|
(22,523
|
)
|
|
|
$
|
19,864
|
|
|
$
|
93
|
|
|
|
|
|
|
|
|
|
|
Novartis Note. On June 4, 2010, the
Company and Novartis entered into a Master Agreement and
Amendment (the Novartis Agreement), pursuant to
which the Company was released and discharged from its
obligations under that certain convertible note to Novartis (the
Novartis Note) in exchange for (i) the
reduction of future royalty and milestone payments up to an
aggregate amount of $11.0 million due the Company under the
Research Collaboration and Option Agreement, dated as of
December 3, 1997, as amended on October 20, 2000 (the
Research Collaboration and Option Agreement), and
the License Agreement, dated as of March 8, 2000, for the
development of an oral salmon calcitonin product for the
treatment of osteoarthritis and osteoporosis (the Oral
Salmon Calcitonin Agreement); (ii) the right for
Novartis to evaluate the feasibility of using Emispheres
Eligen®
Technology with two new compounds to assess the potential for
new product development opportunities; and (iii) other
amendments to the Research Collaboration and Option Agreement
and License Agreement. As of the date of the Novartis Agreement,
the outstanding principal balance and accrued interest of the
Novartis Note was approximately $13.0 million. The Company
recognized the full value of the debt released as consideration
for the transfer of the rights and other intangibles to Novartis
and deferred the related revenue in accordance with applicable
accounting guidance for the sale of rights to future revenue
until the earnings process has been completed based on
achievement of certain milestones or other deliverables.
2010 MHR Promissory Notes. In connection with
the Novartis Agreement, the Company and MHR entered into a
letter agreement (the MHR Letter Agreement), and
MHR, the Company and Novartis entered into a non-disturbance
agreement (the Non-Disturbance Agreement), which was
a condition to Novartis execution of the Novartis
Agreement. Pursuant to the MHR Letter Agreement, MHR agreed to
the limit certain rights and courses of action that it would
have available to it as a secured party under the Senior Secured
Term Loan Agreement and Pledge and Security Agreement
(Loan and Security Agreement) between MHR and the
Company. MHR also consented to the Novartis Agreement, which
consent was required under the Loan and Security Agreement, and
MHR also agreed to enter into a comparable agreement at some
point
72
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
in the future in connection with another potential Company
transaction (the Future Transaction Agreement). The
MHR Letter Agreement also provided for the Company to reimburse
MHR for its legal fess incurred in connection with the
Non-Disturbance Agreement for up to $500,000 and up to $100,000
in legal expenses incurred by MHR in connection the Future
Transaction Agreement. The reimbursements were to be paid in the
form of non-interest bearing promissory notes issued on the
effective date of the MHR Letter Agreement. As such, the Company
issued to MHR non-interest promissory notes for $500,000 and
$100,000 on June 8, 2010. The Company received
documentation that MHR expended more than the $500,000 of legal
fees in connection with the Non-Disturbance Agreement and
$100,000 of legal fees in connection with the Future Transaction
Agreement, and, consequently, recorded the issuance of the
$500,000 and $100,000 promissory notes and a corresponding
charge to financing expenses. The Company has not yet received
any documentation or communication that indicates MHR has spent
any legal fees in connection with the Future Transaction
Agreement. Therefore, the issuance of the $100,000 promissory
note was recorded as a prepaid expense. The promissory notes are
due June 4, 2012. The Company imputed interest at its
incremental borrowing rate of 10%, and discounted the face
amounts of the $500,000 and $100,000 promissory notes by $66,000
and $14,000, respectively.
July 2010 MHR Promissory Note. On
July 29, 2010, we issued to MHR a promissory note in the
principal amount of $525,000 (the July 2010 MHR
Note). The July 2010 MHR Note provides for an interest
rate of 15% per annum, due and payable on October 27, 2010.
During the quarter ended September 30, 2010, certain
conditions caused the maturity date of the July 2010 MHR Note to
accelerate, and the July 2010 MHR Note was paid.
The scheduled repayments of all debt outstanding as of
December 31, 2010 are as follows:
|
|
|
|
|
|
|
Debt
|
|
|
|
(In thousands)
|
|
|
2011
|
|
|
|
|
2012
|
|
|
20,233
|
|
|
|
|
|
|
|
|
$
|
20,233
|
|
|
|
|
|
|
|
|
9.
|
Derivative
Instruments
|
Derivative instruments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Elan Warrant
|
|
$
|
|
|
|
$
|
394
|
|
MHR Convertible Notes
|
|
|
11,166
|
|
|
|
4,591
|
|
MHR 2006 Warrants
|
|
|
646
|
|
|
|
213
|
|
August 2007 Warrants
|
|
|
481
|
|
|
|
141
|
|
August 2009 Warrants
|
|
|
7,807
|
|
|
|
5,092
|
|
August 2009 Placement Agent Warrants
|
|
|
|
|
|
|
349
|
|
June 2010 MHR Warrants
|
|
|
1,495
|
|
|
|
|
|
August 2010 Warrants
|
|
|
10,550
|
|
|
|
|
|
August 2010 MHR Waiver Warrants
|
|
|
1,961
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
34,106
|
|
|
$
|
10,780
|
|
|
|
|
|
|
|
|
|
|
The fair value of the warrants that have exercise price reset
features is estimated using an adjusted Black-Scholes model. The
Company computes valuations, each quarter, using Black-Scholes
model calculations for
73
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
such warrants to account for the various possibilities that
could occur due to various circumstances that could arise in
connection with the contractual terms of said instruments. The
Company weights each Black-Scholes model calculation based on
its estimation of the likelihood of the occurrence of each
circumstance and adjusts relevant Black-Scholes model input to
calculate the value of the derivative at the reporting date.
Elan Warrant. In connection with a
restructuring of debt in March 2005, we issued to Elan
Corporation, plc (Elan) a warrant to purchase up to
600,000 shares of our common stock at an exercise price of
$3.88 (the Elan Warrant). The Elan Warrant provides
for adjustment of the exercise price upon the occurrence of
certain events, including the issuance by Emisphere of common
stock or common stock equivalents that have an effective price
that is less than the exercise price of the warrant. The
anti-dilution feature of the Elan Warrant was triggered in
connection with an equity financing conducted in August 2007
(the August 2007 Financing), resulting in an
adjustment to the exercise price to $3.76. The anti-dilution
feature of the Elan Warrant was triggered again in connection
with an equity financing conducted in August 2009 (the
August 2009 Financing), resulting in an adjustment to the
exercise price to $0.4635. The Company adopted the provisions of
FASB
ASC 815-40-15-5
effective January 1, 2009. Under FASB
ASC 815-40-15-5,
the Elan Warrant is not considered indexed to the Companys
own stock and, therefore, does not meet the scope exception in
FASB
ASC 815-10-15
and thus needs to be accounted for as a derivative liability. On
April 20, 2010, Elan notified the Company of its intention
to exercise the Elan Warrant using the cashless
exercise provision. The Company issued 518,206 shares
of common stock to Elan in accordance with the terms of the
cashless exercise provision on April 21, 2010. After the
cashless exercise, the Elan Warrant is no longer outstanding.
The Company calculated the fair value of the Elan warrants on
April 21, 2010 using the Black-Scholes model. The
assumptions used in computing the fair value as of
April 21, 2010 are a closing stock price of $3.40, expected
volatility of 89.91% over the remaining contractual life of four
months and a risk-free rate of 0.16%. The fair value of the Elan
warrants increased by $1.4 million and $0.3 million
during the years ended December 31, 2010 and 2009,
respectively, which has been recognized in the accompanying
statements of operations. The fair value of the derivative
liability at April 21, 2010 of $1.8 million was
reclassified to additional
paid-in-capital.
Embedded Conversion Feature of MHR Convertible
Notes. The MHR Convertible Notes due to MHR
contain a provision whereby the conversion price is adjustable
upon the occurrence of certain events, including the issuance by
Emisphere of common stock or common stock equivalents at a price
which is lower than the current conversion price of the MHR
Convertible Notes and lower than the current market price.
However, the adjustment provision does not become effective
until after the Company raises $10 million through the
issuance of common stock or common stock equivalents at a price
which is lower than the current conversion price of the
convertible note and lower than the current market price during
any consecutive 24 month period. The Company adopted the
provisions of FASB
ASC 815-40-15-5
effective January 1, 2009. Under FASB
ASC 815-40-15-5,
the embedded conversion feature is not considered indexed to the
Companys own stock and, therefore, does not meet the scope
exception in FASB
ASC 815-10-15
and thus needs to be accounted for as a derivative liability.
The adoption of FASB
ASC 815-40-15-5
requires recognition of the cumulative effect of a change in
accounting principle to the opening balance of our accumulated
deficit, additional paid in capital, and liability for
derivative financial instruments. The liability has been
presented as a non-current liability to correspond with its host
contract, the MHR Convertible Notes. The fair value of the
embedded conversion feature is estimated, at the end of each
quarterly reporting period, using Black-Scholes models. The
assumptions used in computing the fair value as of
December 31, 2010 are a closing stock price of $2.41,
conversion prices of $3.78 and $2.41, expected volatility of
129.74% over the remaining term of one year and nine months and
a risk-free rate of 0.61%. The fair value of the embedded
conversion feature increased by $6.6 million during the
year ended December 31, 2010 which has been recognized in
the accompanying statements of operations. The embedded
conversion feature will be adjusted to estimated fair value for
each future period they remain outstanding. See Note 8 for
a further discussion of the MHR Convertible Notes.
74
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
MHR 2006 Warrants. In connection with the
exercise in April 2006 of the MHR Option discussed in
Note 8 above, the Company issued to MHR warrants to
purchase 617,211 shares (the MHR 2006 Warrants)
for proceeds of $0.6 million. The MHR 2006 Warrants have an
original exercise price of $4.00 and are exercisable through
September 26, 2011. The MHR 2006 Warrants have the same
terms as the August 2007 Warrants (see below), with no limit
upon adjustments to the exercise price. The anti-dilution
feature of the MHR 2006 Warrants was triggered in connection
with the August 2007 Financing, resulting in an adjusted
exercise price of $3.76. Based on the provisions of FASB
ASC 815, Derivatives and Hedging, the MHR 2006
Warrants have been determined to be an embedded derivative
instrument which must be separated from the host contract. The
MHR 2006 Warrants contain the same potential cash settlement
provisions as the August 2007 Financing Warrants and, therefore,
they have been accounted for as a separate liability. The fair
value of the MHR 2006 Warrants is estimated, at the end of each
quarterly period, using Black-Scholes models. The assumptions
used in computing the fair value as of December 31, 2010
are a closing stock price of $2.41, exercise price of $3.76 and
$2.41, expected volatility of 157.26% over the remaining term of
nine months and a risk-free rate of 0.29%. The fair value of the
MHR 2006 Warrants increased by $0.4 million and
$0.1 million for the year ended December 31, 2010 and
2009, respectively and decreased $0.7 million for the year
ended December 31, 2008, and the fluctuation has been
recorded in the statement of operations. The MHR 2006 Warrants
will be adjusted to estimated fair value for each future period
they remain outstanding.
August 2007 Warrants. In connection with the
August 2007 Financing, Emisphere sold warrants to purchase up to
400,000 shares of common stock (the August 2007
Warrants). Of these 400,000 warrants, 91,073 were sold to
MHR. Each of the August 2007 Warrants were issued with an
exercise price of $3.948 and expire on August 21, 2012. The
August 2007 Warrants provide for certain anti-dilution
protection as provided therein. Under the terms of the August
2007 Warrants, we have an obligation to make a cash payment to
the holders of the August 2007 Warrants for any gain that could
have been realized if the holders exercise the August 2007
Warrants and we subsequently fail to deliver a certificate
representing the shares to be issued upon such exercise by the
third trading day after such August 2007 Warrants have been
exercised. Accordingly, the 2007 Warrants have been accounted
for as a liability. The fair value of the warrants is estimated,
at the end of each quarterly reporting period, using the
Black-Scholes model. The August 2007 Warrants were accounted for
with an initial value of $1.0 million on August 22,
2007. The assumptions used in computing the fair value as of
December 31, 2010 are a closing stock price of $2.41,
expected volatility of 130.99% over the remaining term of one
year and eight months and a risk-free rate of 0.61%.
The fair value of the August 2007 Warrants increased
$0.3 million and $0.02 million for the years ended
December 31, 2010 and December 31, 2009, respectively
and decreased by $0.4 million for the year ended
December 31, 2008, and the fluctuations have been recorded
in the statements of operations. The August 2007 Warrants will
be adjusted to estimated fair value for each future period they
remain outstanding.
August 2009 Warrants. In connection with the
August 2009 offering, Emisphere sold warrants to purchase
6.4 million shares of common stock to MHR
(3.7 million) and other unrelated investors
(2.7 million) (the August 2009 Warrants). The
August 2009 Warrants were issued with an exercise price of $0.70
and expire on August 21, 2014. Under the terms of the
August 2009 Warrants, we have an obligation to make a cash
payment to the holders of the August 2009 Warrants for any gain
that could have been realized if the holders exercise the August
2009 Warrants and we subsequently fail to deliver a certificate
representing the shares to be issued upon such exercise by the
third trading day after such August 2009 Warrants have been
exercised. Accordingly, the August 2009 Warrants have been
accounted for as a liability. The fair value of the August 2009
Warrants is estimated, at the end of each quarterly reporting
period, using the Black-Scholes model. The assumptions used in
computing the fair value as of December 31, 2010 are a
closing stock price of $2.41, expected volatility of 115.01%
over the remaining term of three years and eight months and a
risk-free rate of 1.02%. The fair value of the August 2009
Warrants increased $4.8 million for the year ended
December 31, 2010 and $0.85 million from the
commitment date of August 19, 2009 through
December 31, 2009, and the fluctuation has been recorded in
the statements of operations. The warrants will be adjusted to
75
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
estimated fair value for each future period they remain
outstanding. During the year ended December 31, 2010,
certain holders of the August 2009 Warrants notified the Company
of their intention to exercise their warrants to purchase up to
2,685,714 shares of the Companys common stock at an
exercise price of $0.70, using the cashless exercise
provision. The Company issued an aggregate 1,966,937 such
holders in accordance with the terms of the cashless exercise
provision. The Company calculated the fair value of the
2,685,714 exercised warrants on their respective exercise dates
using the Black-Scholes model. The weighted average assumptions
used in computing the fair values were a closing stock price of
$1.91, expected volatility of 101.99% over the remaining
contractual life of four years and three months and a risk-free
rate of 1.46%. The fair value of the 2.7 million exercised
warrants increased by $2.2 million from January 1,
2010 through the date of exercise which has been recognized in
the accompanying statements of operations. The fair value of the
derivative liabilities at the exercise dates of
$4.3 million was reclassified to additional
paid-in-capital.
After these cashless exercises, warrants to purchase up to
3,729,323 shares of common stock, in the aggregate, remain
outstanding.
August 2009 Placement Agent Warrants. In
connection with the August 2009 Financing, Emisphere issued to
the placement agent, as part of the compensation for acting as
placement agent for the August 2009 offering, warrants to
purchase 504,000 shares of common stock (the August
2009 Placement Agent Warrants). The August 2009 Placement
Agent Warrants were issued with an exercise price of $0.875 and
expire on October 1, 2012. Under the terms of the August
2009 Placement Agent Warrants, we have an obligation to make a
cash payment to the holders of the August 2009 Placement Agent
Warrants for any gain that could have been realized if the
holders exercise the August 2009 Placement Agent Warrants and we
subsequently fail to deliver a certificate representing the
shares to be issued upon such exercise by the third trading day
after such August 2009 Placement Agent Warrants have been
exercised. Accordingly, the August 2009 Placement Agent Warrants
have been accounted for as a liability. The fair value of the
warrants are estimated, at the end of each quarterly reporting
period, using the Black-Scholes model. On April 1, 2010,
the holder of the August 2009 Placement Agent Warrants notified
the Company of its intention to exercise a portion of the
warrants using the cashless exercise provision. The
Company issued 297,636 shares of common stock to such
holder in accordance with the terms of the cashless exercise
provision on April 5, 2010. After this cashless exercise,
warrants to purchase 37,800 shares of common stock remained
outstanding. On April 28, 2010, the holder of the August
2009 Placement Agent Warrants notified the Company of its
intention to exercise the remaining outstanding portion of the
August 2009 Placement Agent Warrants using the cashless
exercise provision. The Company issued an additional
27,192 shares of common stock to the purchase agent on
April 30, 2010. After this cashless exercise, the August
2009 Placement Agent Warrants are no longer outstanding. The
Company calculated the fair value of the 466,200 August
2009 Placement Agent Warrants on April 2, 2010 using the
Black-Scholes model. The assumptions used in computing the fair
value as of April 2, 2010 are a closing stock price of
$2.40, expected volatility of 104.70% over the remaining
contractual life of two years and six months and a risk-free
rate of 1.11%. The fair value of the 466,200 August 2009
Placement Agent Warrants increased by $0.6 million from
January 1, 2010 to the date of exercise which has been
recognized in the accompanying statements of operations. The
fair value of the derivative liability from the
466,200 August 2009 Placement Agent Warrants at
April 2, 2010 of $0.9 million was reclassified to
additional
paid-in-capital.
The Company calculated the fair value of the 37,800 August
2009 Placement Agent Warrants on April 29, 2010 using the
Black-Scholes model. The assumptions used in computing the fair
value as of April 29, 2010 are a closing stock price of
$3.05, expected volatility of 107.10% over the remaining
contractual life of two years and five months and a risk-free
rate of 1.11%. The fair value of the 37,800 August 2009
Placement Agent Warrants increased by $46 thousand from
January 1, 2010 to the date of exercise which has been
recognized in the accompany statements of operations. The fair
value of the derivative liability from the 37,800 August
2009 Placement Agent Warrants at April 29, 2010 of
$0.1 million was reclassified to additional
paid-in-capital.
76
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
June 2010 MHR Warrants. As consideration for
its consent and limitation of rights in connection with the
Novartis Agreement, the Company granted MHR warrants to purchase
865,000 shares of its common stock (the June 2010 MHR
Warrants) under the MHR Letter Agreement. The June 2010
MHR Warrants are exercisable at $2.90 per share and will expire
on August 21, 2014. The June 2010 MHR Warrants provide for
certain anti-dilution protection as provided therein. We have an
obligation to make a cash payment to the holders of the warrants
for any gain that could have been realized if the holders
exercise the June 2010 MHR Warrants and we subsequently fail to
deliver a certificate representing the shares to be issued upon
such exercise by the third trading day after such June 2010 MHR
Warrants have been exercised. Accordingly, the June 2010 MHR
Warrants have been accounted for as a liability. Their fair
value is estimated, at the end of each quarterly reporting
period, using the Black-Scholes model. The Company estimated the
fair value of the June 2010 MHR Warrants on the date of grant
using Black-Scholes models to be $1.9 million, which
triggered the recognition of extinguishment and restructuring
accounting for the MHR Convertible Notes (see Notes 8 and
19). The assumptions used in computing the fair value of the
June 2010 MHR Warrants at December 31, 2010 are closing
stock prices of $2.41, $0.42, and $2.89, exercise prices of
$2.41, $0.42, $2.89, and $2.90, expected volatility of 115.01%
over the remaining three years and eight months and a risk-free
rate of 1.02%. The fair value of the June 2010 MHR Warrants
decreased by $0.4 million through December 31, 2010,
and the fluctuation has been recorded in the statements of
operations. The June 2010 MHR Warrants will be adjusted to
estimated fair value for each future period they remain
outstanding.
August 2010 Warrants. In connection with the
August 2010 Financing, Emisphere sold warrants to purchase
5.2 million shares of common stock to MHR
(2.6 million) and other unrelated investors
(2.6 million) (the August 2010 Warrants). The
August 2010 Warrants were issued with an exercise price of $1.26
and expire on August 26, 2015. Under the terms of the
August 2010 Warrants, we have an obligation to make a cash
payment to the holders of the August 2010 Warrants for any gain
that could have been realized if the holders exercise the August
2010 Warrants and we subsequently fail to deliver a certificate
representing the shares to be issued upon such exercise by the
third trading day after such August 2010 Warrants have been
exercised. Accordingly, the August 2010 Warrants have been
accounted for as a liability. The fair value of the warrants is
estimated, at the end of each quarterly reporting period, using
the Black-Scholes model. The assumptions used in computing the
fair value as of December 31, 2010 are a closing stock
price of $2.41, expected volatility of 107.32% over the
remaining term of four years and eight months and a risk-free
rate of 2.01%. The fair value of the August 2010 Warrants were
valued at $4.1 million at the commitment dated of
August 26, 2010 and increased by $6.4 million through
December 31, 2010, and the fluctuation has been recorded in
the statements of operations. The August 2010 Warrants will be
adjusted to estimated fair value for each future period they
remain outstanding.
August 2010 MHR Waiver Warrants. In connection
with the August 2010 Financing, the Company entered into a
waiver agreement with MHR (Waiver Agreement),
pursuant to which MHR waived certain anti-dilution adjustment
rights under the MHR Convertible Notes and certain warrants
issued by the Company to MHR that would otherwise have been
triggered by the August 2010 Financing. As consideration for
such waiver, the Company issued to MHR warrants to purchase
975,000 shares of its common stock (the August 2010
MHR Waiver Warrants). The August 2010 MHR Waiver Warrants
are in the same form of warrant as the August 2010 Warrants
issued to MHR described above. Accordingly, the August 2010 MHR
Waiver Warrants have been accounted for as a liability. The fair
value of the August 2010 MHR Waiver Warrants is estimated, at
the end of each quarterly reporting period, using Black-Scholes
models. The Company estimated the fair value of the warrants on
the date of grant using Black-Scholes models to be
$0.8 million. The assumptions used in computing the fair
value of the August 2010 MHR Waiver Warrants at
December 31, 2010 are a closing stock price of $2.41,
exercise price of $1.26, expected volatility of 107.32% over the
term of four years and eight months and a risk free rate of
2.01%. The fair value of the August 2010 MHR Waiver Warrants
increased by $1.2 million through December 31, 2010,
and the fluctuation has been recorded in the
77
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
statements of operations. The August 2010 MHR Waiver Warrants
will be adjusted to estimated fair value for each future period
they remain outstanding.
Since the Company has recurring losses and a valuation allowance
against deferred tax assets, there is no tax expense (benefit)
for all periods presented.
As of December 31, 2010, we have available unused federal
net operating loss (NOL) carry-forwards of $344 million and
New York NOL carry-forwards of $296 million, of which
$4.4 million, $1.1 million and $15.6 million will
expire in 2011, 2012 and 2013, respectively, with the remainder
expiring in various years from 2019 to 2030. We have New Jersey
NOL carry-forwards of $51.5 million, which will expire in
2014 through 2017. We have research and development tax credit
carry-forwards which will expire in various years from 2011
through 2030.
The effective rate differs from the statutory rate of 34% for
2010, 2009, and 2008 primarily due to the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
Statutory rate on pre-tax book loss
|
|
|
(34.00
|
)%
|
|
|
(34.00
|
)%
|
|
|
(34.00
|
)%
|
Stock option issuance
|
|
|
0.19
|
%
|
|
|
1.62
|
%
|
|
|
0.32
|
%
|
Disallowed interest
|
|
|
9.96
|
%
|
|
|
(13.51
|
)%
|
|
|
0.93
|
%
|
Derivatives
|
|
|
14.13
|
%
|
|
|
5.74
|
%
|
|
|
(3.09
|
)%
|
Research and experimentation tax credit
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
(0.71
|
)%
|
Expired net operating losses and credits
|
|
|
1.53
|
%
|
|
|
20.14
|
%
|
|
|
12.12
|
%
|
Other
|
|
|
0.01
|
%
|
|
|
(0.01
|
)%
|
|
|
0.04
|
%
|
Change in federal valuation allowance
|
|
|
8.18
|
%
|
|
|
20.02
|
%
|
|
|
24.39
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
78
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
The tax effect of temporary differences, net operating loss
carry-forwards, and research and experimental tax credit
carry-forwards as of December 31, 2010 and 2009 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(In thousands)
|
|
|
Deferred tax assets and valuation allowance:
|
|
|
|
|
|
|
|
|
Current deferred tax asset:
|
|
|
|
|
|
|
|
|
Accrued liabilities
|
|
$
|
218
|
|
|
$
|
1,213
|
|
Valuation allowance
|
|
|
(218
|
)
|
|
|
(1,213
|
)
|
|
|
|
|
|
|
|
|
|
Net current deferred tax asset
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Non-current deferred tax assets:
|
|
|
|
|
|
|
|
|
Fixed and intangible assets
|
|
$
|
(87
|
)
|
|
$
|
(50
|
)
|
Net operation loss carry-forwards
|
|
|
120,034
|
|
|
|
122,296
|
|
AMT credit carry-forwards
|
|
|
74
|
|
|
|
|
|
Capital loss and charitable carry-forwards
|
|
|
2,779
|
|
|
|
2,779
|
|
Research and experimental tax credits
|
|
|
11,986
|
|
|
|
12,188
|
|
Stock compensation
|
|
|
997
|
|
|
|
808
|
|
Deferred revenue
|
|
|
12,595
|
|
|
|
4,591
|
|
Interest
|
|
|
3,461
|
|
|
|
2,534
|
|
Valuation allowance
|
|
|
(151,839
|
)
|
|
|
(145,146
|
)
|
|
|
|
|
|
|
|
|
|
Net non-current deferred tax asset
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Future ownership changes may limit the future utilization of
these net operating loss and research and development tax credit
carry-forwards as defined by the Internal Revenue Code. The
amount of any potential limitation is unknown. The net deferred
tax asset has been fully offset by a valuation allowance due to
our history of taxable losses and uncertainty regarding our
ability to generate sufficient taxable income in the future to
utilize these deferred tax assets.
On January 1, 2007, we adopted the provisions of
ASC 740-10-25.
ASC 740-10-25
provides recognition criteria and a related measurement model
for uncertain tax positions taken or expected to be taken in
income tax returns.
ASC 740-10-25
requires that a position taken or expected to be taken in a tax
return be recognized in the financial statements when it is more
likely than not that the position would be sustained upon
examination by tax authorities. Tax positions that meet the more
likely than not threshold are then measured using a probability
weighted approach recognizing the largest amount of tax benefit
that is greater than 50% likely of being realized upon ultimate
settlement. The Company had no tax positions relating to open
income tax returns that were considered to be uncertain.
Accordingly, we have not recorded a liability for unrecognized
tax benefits upon adoption of
ASC 740-10-25.
There continues to be no liability related to unrecognized tax
benefits at December 31, 2009.
The Companys 2007, 2008 and 2009 federal, New York and New
Jersey tax returns remain subject to examination by the
respective taxing authorities. In addition, net operating losses
and research tax credits arising from prior years are also
subject to examination at the time that they are utilized in
future years. Neither the Companys federal or state tax
returns are currently under examination.
79
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
11.
|
Stockholders
Deficit
|
On April 20, 2007, the stockholders of the Company approved
an increase in the Companys authorized common stock from
50 million to 100 million shares.
Our certificate of incorporation provides for the issuance of
1,000,000 shares of preferred stock with the rights,
preferences, qualifications, and terms to be determined by our
Board of Directors. As of December 31, 2010 and 2009, there
were no shares of preferred stock outstanding.
We have a stockholder rights plan in which Preferred Stock
Purchase Rights (the Rights) have been granted at
the rate of one one-hundredth of a share of Series A Junior
Participating Cumulative Preferred Stock (A Preferred
Stock) at an exercise price of $80 for each share of our
common stock. The Rights expire on April 7, 2016.
The Rights are not exercisable, or transferable apart from the
common stock, until the earlier of (i) ten days following a
public announcement that a person or group of affiliated or
associated persons have acquired beneficial ownership of 20% or
more of our outstanding common stock or (ii) ten business
days (or such later date, as defined) following the commencement
of, or announcement of an intention to make a tender offer or
exchange offer, the consummation of which would result in the
beneficial ownership by a person, or group, of 20% or more of
our outstanding common stock. MHR is specifically excluded from
the provisions of the plan.
Furthermore, if we enter into consolidation, merger, or other
business combinations, as defined, each Right would entitle the
holder upon exercise to receive, in lieu of shares of A
Preferred Stock, a number of shares of common stock of the
acquiring company having a value of two times the exercise price
of the Right, as defined. The Rights contain anti-dilutive
provisions and are redeemable at our option, subject to certain
defined restrictions for $.01 per Right.
As a result of the Rights dividend, the Board of Directors
designated 200,000 shares of preferred stock as A Preferred
Stock. A Preferred Stockholders will be entitled to a
preferential cumulative quarterly dividend of the greater of
$1.00 per share or 100 times the per share dividend declared on
our common stock. Shares of A Preferred Stock have a liquidation
preference, as defined, and each share will have 100 votes and
will vote together with the common shares.
|
|
12.
|
Stock-Based
Compensation Plans
|
Total compensation expense recorded during the years ended
December 31, 2010, 2009 and 2008 for share-based payment
awards was $0.8 million, $1.6 million and
$1.0 million, respectively, of which $0.1 million,
$0.1 million and $0.4 million is recorded in research
and development and $0.7 million, $1.5 million and
$0.6 million is recorded in general and administrative
expenses in the statement of operations. At December 31,
2010, total unrecognized estimated compensation expense related
to non-vested stock options granted prior to that date was
approximately $0.6 million, which is expected to be
recognized over a weighted-average period of 2.2 years. No
tax benefit was realized due to a continued pattern of operating
losses. We have a policy of issuing new shares to satisfy share
option exercises. There were no options exercised during the
years ended December 31, 2010 and 2009. Cash received from
options exercised totaled $0.01 million for the year ended
December 31, 2008.
Using the Black-Scholes model, we have estimated our stock price
volatility using the historical volatility in the market price
of our common stock for the expected term of the option. The
risk-free interest rate is based on the yield curve of
U.S. Treasury STRIP securities for the expected term of the
option. We have never paid cash dividends and do not intend to
pay cash dividends in the foreseeable future. Accordingly, we
assumed a 0% dividend yield. The forfeiture rate is estimated
using historical option cancellation information, adjusted for
anticipated changes in expected exercise and employment
termination behavior. Forfeiture rates and the expected term of
options are estimated separately for groups of employees that
have similar historical
80
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
exercise behavior. The ranges presented below are the result of
certain groups of employees displaying different behavior.
The following weighted-average assumptions were used for grants
made under the stock option plans for the years ended
December 31, 2010, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
Directors
|
|
Executives
|
|
Employees
|
|
Expected volatility
|
|
|
95.5
|
%
|
|
|
85.7
|
%
|
|
|
85.7
|
%
|
Expected term
|
|
|
6.8 years
|
|
|
|
6.8 years
|
|
|
|
6.8 years
|
|
Risk-free interest rate
|
|
|
2.17
|
%
|
|
|
3.14
|
%
|
|
|
3.20
|
%
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Annual forfeiture rate
|
|
|
14.5
|
%
|
|
|
14.5
|
%
|
|
|
14.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
Directors
|
|
Executives
|
|
Employees
|
|
Expected volatility
|
|
|
87.8
|
%
|
|
|
87.8
|
%
|
|
|
87.9
|
%
|
Expected term
|
|
|
6.8 years
|
|
|
|
6.8 years
|
|
|
|
6.8 years
|
|
Risk-free interest rate
|
|
|
3.19
|
%
|
|
|
3.14
|
%
|
|
|
2.9
|
%
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Annual forfeiture rate
|
|
|
5
|
%
|
|
|
5
|
%
|
|
|
5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
Directors
|
|
Executives
|
|
Employees
|
|
Expected volatility
|
|
|
84.9
|
%
|
|
|
85.0
|
%
|
|
|
85.0
|
%
|
Expected term
|
|
|
10 years
|
|
|
|
10 years
|
|
|
|
10 years
|
|
Risk-free interest rate
|
|
|
3.89
|
%
|
|
|
3.89
|
%
|
|
|
3.89
|
%
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Annual forfeiture rate
|
|
|
5
|
%
|
|
|
5
|
%
|
|
|
5
|
%
|
Stock Option Plans. On April 20, 2007,
the stockholders approved the 2007 Stock Award and Incentive
Plan (the 2007 Plan). The 2007 Plan provides for
grants of options, stock appreciation rights, restricted stock,
deferred stock, bonus stock and awards in lieu of obligations,
dividend equivalents, other stock based awards and performance
awards to executive officers and other employees of the Company,
and non-employee directors, consultants and others who provide
substantial service to us. The 2007 Plan provides for the
issuance of 3,275,334 shares as follows: 2,500,000 new
shares, 374,264 shares remaining and transferred from the
Companys 2000 Stock Option Plan (the 2000
Plan) (which was then replaced by the 2007 Plan) and
401,070 shares remaining and transferred from the
Companys Stock Option Plan for Outside Directors (the
Directors Stock Plan). In addition, shares
cancelled, expired, forfeited, settled in cash, settled by
delivery of fewer shares than the number underlying the award,
or otherwise terminated under the 2000 Plan will become
available for issuance under the 2007 Plan, once registered. As
of December 31, 2010 1,278,558 shares remain available
for issuance under the 2007 Plan. Generally, the options vest at
the rate of 20% per year and expire within a
five-to-ten-year
period, as determined by the compensation committee of the Board
of Directors and as defined by the Plans.
The Companys other active Stock Option Plan is the 2002
Broad Based Plan (the 2002 Plan). Under the 2002
Plan, a maximum of 160,000 shares are authorized for
issuance to employees in the form of either incentive stock
options (ISOs), as defined by the Internal Revenue
Code, or non-qualified stock options,
81
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
which do not qualify as ISOs. As of December 31, 2010,
153,590 shares remain available for issuance under the 2002
Plan.
The Company also has grants outstanding under various expired
and terminated Stock Option Plans, including the 1991 Stock
Option Plan (the 1991 Plan), the 1995 Non-Qualified
Stock Option Plan (the 1995 Plan) and the 2000 Plan.
Under our 1991, 1995 and 2000 Plans a maximum of 2,500,000,
2,550,000 and 1,945,236 shares of our common stock,
respectively, were available for issuance. The 1991 Plan was
available to employees and consultants; the 2000 Plan was
available to employees, directors and consultants. The 1991 Plan
and 2000 Plan provide for the grant of either ISOs, as defined
by the Internal Revenue Code, or non-qualified stock options,
which do not qualify as ISOs. The 1995 Plan provides for grants
of non-qualified stock options to officers and key employees.
Generally, the options vest at the rate of 20% per year and
expire within a five- to ten-year period, as determined by the
compensation committee of the Board of Directors and as defined
by the Plans.
Transactions involving stock options awarded under the Plans
described above during the years ended December 31, 2010,
2009 and 2008 are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Remaining
|
|
|
|
|
|
|
Number of
|
|
|
Average
|
|
|
Contractual
|
|
|
Aggregate
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Term in Years
|
|
|
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
Outstanding at December 31, 2007
|
|
|
2,867,876
|
|
|
$
|
8.73
|
|
|
|
6.4
|
|
|
|
|
|
Granted
|
|
|
133,600
|
|
|
$
|
2.84
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(300,087
|
)
|
|
$
|
12.72
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(664,385
|
)
|
|
$
|
8.75
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(4,150
|
)
|
|
$
|
3.04
|
|
|
|
|
|
|
$
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
2,032,854
|
|
|
$
|
8.30
|
|
|
|
6.7
|
|
|
|
|
|
Granted
|
|
|
1,041,000
|
|
|
$
|
0.86
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(12,643
|
)
|
|
$
|
14.63
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(326,475
|
)
|
|
$
|
3.88
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
2,734,736
|
|
|
$
|
6.29
|
|
|
|
6.8
|
|
|
$
|
51
|
|
Granted
|
|
|
662,750
|
|
|
$
|
1.41
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(183,500
|
)
|
|
$
|
37.99
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(48,120
|
)
|
|
$
|
1.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2010
|
|
|
3,165,866
|
|
|
$
|
3.51
|
|
|
|
6.9
|
|
|
$
|
46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at December 31, 2010
|
|
|
2,367,037
|
|
|
$
|
4.22
|
|
|
|
6.2
|
|
|
$
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at December 31, 2010
|
|
|
2,906,445
|
|
|
$
|
3.70
|
|
|
|
6.7
|
|
|
$
|
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant date fair value of options granted
during the years ended December 31, 2010, 2009 and 2008 was
$1.26, $0.92 and $2.16, respectively.
Outside Directors Plan. We previously
issued options to outside directors who are neither officers nor
employees of Emisphere nor holders of more than 5% of our common
stock under the Directors Stock Plan. As amended, a maximum of
725,000 shares of our common stock were available for
issuance under the Outside Directors Plan in the form of
options and restricted stock. The Directors Stock Plan expired
on January 29, 2007. Options and restricted stock are now
granted to directors under the 2007 Plan discussed above.
82
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
Transactions involving stock options awarded under the Directors
Stock Plan during the years ended December 31, 2010, 2009
and 2008 are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Remaining
|
|
|
|
|
|
|
Number of
|
|
|
Average
|
|
|
Contractual
|
|
|
Aggregate
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Term in Years
|
|
|
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
Outstanding at December 31, 2007
|
|
|
156,000
|
|
|
$
|
13.38
|
|
|
|
5.0
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
156,000
|
|
|
$
|
13.38
|
|
|
|
4.0
|
|
|
|
|
|
Expired
|
|
|
(35,000
|
)
|
|
$
|
4.23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
121,000
|
|
|
$
|
15.59
|
|
|
|
2.7
|
|
|
|
|
|
Expired
|
|
|
(21,000
|
)
|
|
$
|
41.06
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2010
|
|
|
100,000
|
|
|
$
|
10.24
|
|
|
|
2.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Exercisable at December 31, 2010
|
|
|
100,000
|
|
|
$
|
10.24
|
|
|
|
2.2
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors Deferred Compensation Stock
Plan. The Directors Deferred Compensation
Stock Plan (the Directors Deferred Plan)
ceased as of May 2004. Under the Directors Deferred Plan,
directors who were neither officers nor employees of Emisphere
had the option to elect to receive one half of the annual Board
of Directors retainer compensation, paid for services as a
Director, in deferred common stock. An aggregate of
25,000 shares of our common stock has been reserved for
issuance under the Directors Deferred Plan. During the
years ended December 31, 2004 and 2003, the outside
directors earned the rights to receive an aggregate of
1,775 shares and 2,144 shares, respectively. Under the
terms of the Directors Deferred Plan, shares are to be
issued to a director within six months after he or she ceases to
serve on the Board of Directors. We recorded as an expense the
fair market value of the common stock issuable under the plan.
As of December 31, 2010, there are 3,122 shares
issuable under this plan. No grants were awarded in 2010, 2009
and 2008, and none were outstanding as of December 31, 2010.
Non-Plan Options. Our Board of Directors has
granted options (Non-Plan Options), which are
currently outstanding for the accounts of two consultants. The
Board of Directors determines the number and terms of each grant
(option exercise price, vesting, and expiration date).
83
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
Transactions involving awards of Non-Plan Options during the
year ended December 31, 2010, 2009 and 2008 are summarized
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Remaining
|
|
|
|
|
|
|
Number of
|
|
|
Average
|
|
|
Contractual
|
|
|
Aggregate
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Term in Years
|
|
|
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
|
Outstanding at December 31, 2007
|
|
|
20,000
|
|
|
$
|
14.84
|
|
|
|
4.3
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
20,000
|
|
|
$
|
14.84
|
|
|
|
3.3
|
|
|
|
|
|
Expired
|
|
|
(10,000
|
)
|
|
$
|
26.05
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
10,000
|
|
|
$
|
3.64
|
|
|
|
2.0
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2010
|
|
|
10,000
|
|
|
$
|
3.64
|
|
|
|
2.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Exercisable at December 31, 2010
|
|
|
10,000
|
|
|
$
|
3.64
|
|
|
|
2.0
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.
|
Collaborative
Research Agreements
|
We are a party to collaborative agreements with corporate
partners to provide development and commercialization services
relating to the collaborative products. These agreements are in
the form of research and development collaboration and licensing
agreements. In connection with these agreements, we have granted
licenses or the rights to obtain licenses to our oral drug
delivery technology. In return, we are entitled to receive
certain payments upon the achievement of milestones and will
receive royalties on sales of products should they be
commercialized. Under these agreements, we are entitled to also
be reimbursed for research and development costs. We also have
the right to manufacture and supply delivery agents developed
under these agreements to our corporate partners.
We also perform research and development for others pursuant to
feasibility agreements, which are of short duration and are
designed to evaluate the applicability of our drug delivery
agents to specific drugs. Under the feasibility agreements, we
are generally reimbursed for the cost of work performed.
All of our collaborative agreements are subject to termination
by our corporate partners without significant financial penalty
to them. Milestone and upfront payments received in connection
with these agreements was $7.0 million, $0.2 million
and $11.4 million in the years ended December 31,
2010, 2009 and 2008, respectively. Expense reimbursements
received in connection with these agreements was
$0.1 million, $0.2 million and $1.3 million for
the years ended December 31, 2010, 2009 and 2008,
respectively. Expenses incurred in connection with these
agreements and included in research and development were
$0.0 million, $0.2 million and $0.1 million in
the years ended December 31, 2010, 2009 and 2008,
respectively. Significant agreements are described below.
Novartis. On June 4, 2010, the Company
and Novartis entered into the Novartis Agreement, pursuant
which, the Company was released and discharged from its
obligations under the Novartis Note in exchange for (i) the
reduction of future royalty and milestone payments up to an
aggregate amount of $11.0 million due the Company under the
Research Collaboration and Option Agreement and the Oral Salmon
Calcitonin License Agreement, date as of March 8, 2000, for
the development of an oral salmon calcitonin product for the
treatment of osteoarthritis and osteoporosis; (ii) the
right for Novartis to evaluate the feasibility of using
Emispheres
Eligen®
Technology with two new compounds to assess the potential for
new product development opportunities; and (iii) other
amendments to the Research Collaboration and Option Agreement
and
84
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
License Agreement. As of the date of the Novartis Agreement, the
outstanding principal balance and accrued interest of the
Novartis Note was approximately $13.0 million. The Company
recognized the full value of the debt released as consideration
for the transfer of the rights and other intangibles to Novartis
and deferred the related revenue in accordance with applicable
accounting guidance for the sale of rights to future revenue
until the earnings process has been completed based on
achievement of certain milestones or other deliverables.
2008
Novo Nordisk Agreement
On June 21, 2008, we entered into an exclusive Development
and License Agreement with Novo Nordisk pursuant to which Novo
Nordisk will develop and commercialize oral formulations of Novo
Nordisk proprietary products in combination with Emisphere
carriers (the GLP-1 License Agreement). Under such
the GLP-1 License Agreement, Emisphere could receive more than
$87.0 million in contingent product development and sales
milestone payments including a $10.0 million non-refundable
license fee which was received during June 2008. Emisphere would
also be entitled to receive royalties in the event Novo Nordisk
commercializes products developed under such agreement. Under
the terms of the GLP-1 License Agreement, Novo Nordisk is
responsible for the development and commercialization of the
products. Initially Novo Nordisk is focusing on the development
of oral formulations of its proprietary GLP-1 receptor agonists.
In January 2010, Novo Nordisk had its first Phase I clinical
trial with a long acting oral GLP-1 receptor agonist. This
milestone released a $2 million payment to Emisphere.
The GLP-1 License Agreement includes multiple deliverables
including the license grant, several versions of the
Companys
Eligen®
Technology (or carriers), support services and manufacturing.
Emisphere management reviewed the relevant terms of the Novo
Nordisk agreement and determined that such deliverables should
be accounted for as a single unit of accounting in accordance
with FASB
ASC 605-25,
Multiple-Element Arrangements, since the delivered
license and
Eligen®
Technology do not have stand-alone value and Emisphere does not
have objective evidence of fair value of the undelivered
Eligen®
Technology or the manufacturing value of all the undelivered
items. Such conclusion will be reevaluated as each item in the
arrangement is delivered. Consequently, any payments received
from Novo Nordisk pursuant to such agreement, including the
initial $10 million upfront payment and any payments
received for support services, will be deferred and included in
Deferred Revenue within our balance sheet. Management cannot
currently estimate when all of such deliverables will be
delivered nor can they estimate when, if ever, Emisphere will
have objective evidence of the fair value for all of the
undelivered items, therefore all payments from Novo Nordisk are
expected to be deferred for the foreseeable future.
As of December 31, 2010 total deferred revenue from the
2008 agreement with Novo Nordisk was $13.6 million,
comprised of the $10.0 million non-refundable license fee,
$2 million milestone payment and $1.6 million in
support services.
2010
Novo Nordisk Agreement
On December 20, 2010, we entered into an exclusive
Development and License Agreement with Novo Nordisk, pursuant to
which we granted to Novo Nordisk an exclusive license to develop
and commercialize oral formulations of Novo Nordisks
insulins, using the Companys proprietary delivery agents
(the Insulin Agreement). The Insulin Agreement
includes $57.5 million in potential product development and
sales milestone payments including a $5.0 million non-
refundable, non-creditable license fee. Emisphere would also be
entitled to receive royalties in the event Novo Nordisk
commercializes products developed under such the Insulin
Agreement.
The Insulin Agreement includes multiple deliverables including
the license grant, several versions of the Companys
Eligen®
Technology (or carriers), support services and manufacturing.
Emisphere management reviewed the relevant terms of the Novo
Nordisk agreement and determined that such deliverables should
be accounted for as a single unit of accounting in accordance
with FASB ASC
605-25,
Multiple-Element Arrangements, since the delivered
license and
Eligen®
Technology do not have stand-alone value and Emisphere does not
have objective evidence of fair value of the undelivered
Eligen®
Technology or the
85
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
manufacturing value of all the undelivered items. Such
conclusion will be reevaluated as each item in the arrangement
is delivered. Consequently any payments received from Novo
Nordisk pursuant to such agreement, including the initial
$5.0 million upfront payment and any payments received for
support services, will be deferred and included in Deferred
Revenue within our balance sheet. Management cannot currently
estimate when all of such deliverables will be delivered nor can
they estimate when, if ever, Emisphere will have objective
evidence of the fair value for all of the undelivered items,
therefore all payments from Novo Nordisk are expected to be
deferred for the foreseeable future.
As of December 31, 2010 total deferred revenue from the
2010 agreement with Novo Nordisk was $5.0 million,
comprised of the non-refundable, non-creditable license fee.
Genta. In March 2006, we entered into a
collaborative agreement with Genta to develop an oral
formulation of a gallium-containing compound. We currently
receive reimbursements from Genta for the work performed during
the formulation phase. We recognized $0.0, $0.0 million and
$0.1 million in revenue related to these reimbursements for
the years ended December 31, 2010, 2009 and 2008,
respectively. We are eligible for future milestone payments
totaling up to a maximum of $24.3 million under this
agreement.
|
|
14.
|
Defined
Contribution Retirement Plan
|
We have a defined contribution retirement plan (the
Retirement Plan), the terms of which, as amended,
allow eligible employees who have met certain age and service
requirements to participate by electing to contribute a
percentage of their compensation to be set aside to pay their
future retirement benefits, as defined by the Retirement Plan.
We have agreed to make discretionary contributions to the
Retirement Plan. For the years ended December 31, 2010,
2009 and 2008, we made contributions to the Retirement Plan
totaling approximately $0.07 million, $0.06 million
and $0.2 million, respectively.
The following table sets forth the information needed to compute
basic and diluted earnings per share for the years ended
December 31, 2010, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009 restated
|
|
|
2008
|
|
|
|
(In thousands, except per share amounts)
|
|
|
Basic and diluted net loss
|
|
$
|
(56,909
|
)
|
|
$
|
(16,821
|
)
|
|
$
|
(24,388
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
46,206,803
|
|
|
|
34,679,321
|
|
|
|
30,337,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.23
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(0.80
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth the number of potential shares of
common stock that have been excluded from diluted net loss per
share because their effect was anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
Options to purchase common shares
|
|
|
2,477,037
|
|
|
|
2,865,736
|
|
|
|
2,208,854
|
|
Outstanding warrants and options to purchase warrants
|
|
|
11,832,826
|
|
|
|
9,934,253
|
|
|
|
2,972,049
|
|
Novartis convertible note payable
|
|
|
|
|
|
|
14,944,980
|
|
|
|
7,537,921
|
|
MHR note payable
|
|
|
6,675,512
|
|
|
|
5,983,146
|
|
|
|
5,362,596
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,985,375
|
|
|
|
33,728,115
|
|
|
|
18,081,420
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
86
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
16.
|
Commitments
and Contingencies
|
Commitments. At the beginning of 2009, we had
leased approximately 80,000 square feet of office space at
765 Old Saw Mill River Road, Tarrytown, NY for use as
administrative offices and laboratories. The lease for our
administrative and laboratory facilities had been set to expire
on August 31, 2012. However, on April 29, 2009, the
Company entered into a Lease Termination Agreement (the
Lease Agreement) with
BMR-Landmark
at Eastview, LLC, a Delaware limited liability company
(BMR) pursuant to which the Company and BMR
terminated the lease of space at 765 Old Saw Mill River Road in
Tarrytown, NY. Pursuant to the Lease Agreement, the Lease was
terminated effective as of April 1, 2009. The Lease
Agreement provided that the Company make the following payments
to BMR: (a) $1 million, paid upon execution of the
Lease Agreement, (b) $0.5 million, paid six months
after the execution date of the Lease Agreement, and
(c) $0.75 million, payable twelve months after the
execution date of the Lease Agreement. Initial and six months
payments were made on schedule. Although the final payment was
due originally on April 29, 2010, on March 17, 2010
the Company and BMR agreed to amend the Lease Agreement (the
Lease Amendment). According to the Lease Amendment,
the final payment was modified as follows: the Company will pay
Eight Hundred Thousand Dollars ($800,000), as follows:
(i) Two Hundred Thousand Dollars ($200,000) within five
(5) days after the Execution Date and (ii) One Hundred
Thousand Dollars ($100,000) on each of the following dates:
July 15, 2010, August 15, 2010, September 15,
2010, October 15, 2010, November 15, 2010, and
December 15, 2010. Through March 1, 2011 the Company
paid $600,000 of the principal plus $21,000 interest for late
payments in accordance with the terms of the Lease Agreement.
We continue to lease office space at 240 Cedar Knolls Road,
Cedar Knolls, NJ under a non-cancellable operating lease
expiring in 2013.
As of December 31, 2010, future minimum rental payments are
as follows:
|
|
|
|
|
Years Ending December 31,
|
|
|
|
|
|
(In thousands)
|
|
|
2011
|
|
|
353
|
|
2012
|
|
|
360
|
|
2013
|
|
|
31
|
|
|
|
|
|
|
Total
|
|
|
744
|
|
Rent expense for the years ended December 31, 2010, 2009
and 2008 was $0.3 million, $0.7 million and
$2.3 million, respectively. Additional charges under this
lease for real estate taxes and common maintenance charges for
the years ended December 31, 2010, 2009 and 2008, were
$0.03 million, $0.5 million and $0.8 million,
respectively.
In accordance with the lease agreement in Cedar Knolls, NJ, the
Company has entered into a standby letter of credit in the
amount of $246 thousand as a security deposit. The standby
letter of credit is fully collateralized with a time certificate
of deposit account in the same amount. The certificate of
deposit has been recorded as a restricted cash balance in the
accompanying financials. As of December 31, 2010, there are
no amounts outstanding under the standby letter of credit.
In April 2005, the Company entered into an amended and restated
employment agreement with its then Chief Executive Officer,
Dr. Michael M. Goldberg, for services through July 31,
2007. On January 16, 2007, the Board of Directors
terminated Dr. Goldbergs services. On April 26,
2007, the Board of Directors held a special hearing at which it
determined that Dr. Goldbergs termination was for
cause. On March 22, 2007, Dr. Goldberg, through his
counsel, filed a demand for arbitration asserting that his
termination was without cause and seeking $1,048,000 plus
attorneys fees, interest, arbitration costs and other
relief alleged to be owed to him in connection with his
employment agreement with the Company. During the arbitration,
Dr. Goldberg sought a total damage amount of at least
$9,223,646 plus interest. On February 11, 2010, the
arbitrator issued the final award in favor of Dr. Goldberg
87
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
for a total amount of approximately $2,333,115 plus interest and
fees as full and final payment for all claims, defenses,
counterclaims, and related matters. The Company opposed
Dr. Goldbergs petition to confirm the arbitration
award. On July 12, 2010 the award was confirmed by the
court. As of August 10, 2010, the Company adjusted its
estimate of costs to settle this matter to approximately
$2.6 million to account for potential additional interest
costs on the settlement amount and additional legal fees. On
September 23, 2010, the Company paid approximately
$2.6 million as the full and final settlement of this
matter.
The Company evaluates the financial consequences of legal
actions periodically or as facts present themselves and books
accruals to account for its best estimate of future costs
accordingly.
Contingencies. In the ordinary course of
business, we enter into agreements with third parties that
include indemnification provisions which, in our judgment, are
normal and customary for companies in our industry sector. These
agreements are typically with business partners, clinical sites,
and suppliers. Pursuant to these agreements, we generally agree
to indemnify, hold harmless, and reimburse indemnified parties
for losses suffered or incurred by the indemnified parties with
respect to our product candidates, use of such product
candidates, or other actions taken or omitted by us. The maximum
potential amount of future payments we could be required to make
under these indemnification provisions is unlimited. We have not
incurred material costs to defend lawsuits or settle claims
related to these indemnification provisions. As a result, the
estimated fair value of liabilities relating to these provisions
is minimal. Accordingly, we have no liabilities recorded for
these provisions as of December 31, 2010.
In the normal course of business, we may be confronted with
issues or events that may result in a contingent liability.
These generally relate to lawsuits, claims, environmental
actions or the action of various regulatory agencies. If
necessary, management consults with counsel and other
appropriate experts to assess any matters that arise. If, in our
opinion, we have incurred a probable loss as set forth by
accounting principles generally accepted in the U.S., an
estimate is made of the loss and the appropriate accounting
entries are reflected in our financial statements. After
consultation with legal counsel, we do not anticipate that
liabilities arising out of currently pending or threatened
lawsuits and claims will have a material adverse effect on our
financial position, results of operations or cash flows.
Restructuring
Expense
On December 8, 2008, as part of our efforts to improve
operational efficiency we decided to close our research and
development facilities in Tarrytown to reduce costs and improve
operating efficiency. As of December 8, 2008 we terminated
all research and development staff and ceased using
approximately 85% of the facilities which resulted in a
restructuring charge of approximately $3.8 million in the
fourth quarter, 2008. As part of the restructuring charge, we
wrote down the value of our leasehold improvements in Tarrytown
by approximately $1.0 million (net); additionally, the
useful life of leasehold improvements in portions of the
facility that were still in use as of December 31, 2008 was
recalculated, resulting in an accelerated charge to amortization
expense of approximately $0.1 million.
In accordance with FASB
ASC 420-10-5,
Exit or Disposal Cost Obligations, we estimated our
liability for net costs associated with terminating our lease
obligation for the laboratory and office facilities in Tarrytown
and recorded a charge net of estimated sublease income. To
develop our estimate, we considered our liability under the
Tarrytown lease, and estimated costs to be incurred to satisfy
rental commitments under the lease, the lead time
necessary to sublease the space, projected sublease rental
rates, and the anticipated duration of subleases. We validated
our estimate and assumptions through consultations with
independent third parties having relevant expertise. We used a
credit adjusted risk free rate of 1.55% to discount
estimated cash flows. We intend to review our estimate and
assumptions on a quarterly basis or more frequently as
appropriate; and will make modifications to the estimated
liability as deemed appropriate, based on our judgment to
reflect changing circumstances. Any change in our estimate may
result in additional restructuring charges, and those charges
may be material.
88
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
The restructuring liability at December 31, 2008 of
$2.9 million related primarily to the portion of the
Tarrytown facility we ceased using as of December 8, 2008,
and was recorded at net present value, and included several
obligations related to the restructuring. We classified
$0.9 million as short term as of December 31, 2008 and
$2.0 million as long term. We recorded $3.8 million in
restructuring expenses comprised of $2.6 million lease
restructuring expense (net of subleases), $0.2 million in
termination benefits (employee severance and related costs) and
$1.0 million in leasehold improvement abandonment. In
December 2008, we made $47 thousand in net rental payments
(calculated at net present value) on the Tarrytown property and
made termination payments of $91 thousand which represent
employee severance and benefits charges. The restructuring
liability was reduced by these amounts.
See also the description of the Terminated Lease Agreement
described in Commitments and Contingencies
above.
The restructuring activity and related liability are as follows
($ thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability at
|
|
|
Lease
|
|
|
|
|
|
Liability at
|
|
|
Lease
|
|
|
|
|
|
Liability at
|
|
|
|
December 31,
|
|
|
Termination
|
|
|
Cash
|
|
|
December 31,
|
|
|
Termination
|
|
|
Cash
|
|
|
December 31,
|
|
|
|
2008
|
|
|
Adjustment
|
|
|
Payments
|
|
|
2009
|
|
|
Adjustment
|
|
|
Payments
|
|
|
2010
|
|
|
Lease restructuring expense
|
|
$
|
2,772
|
|
|
$
|
(353
|
)
|
|
$
|
(1,669
|
)
|
|
$
|
750
|
|
|
$
|
50
|
|
|
$
|
(500
|
)
|
|
$
|
300
|
|
Employee severance and related costs
|
|
|
108
|
|
|
|
(3
|
)
|
|
|
(105
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,880
|
|
|
$
|
(356
|
)
|
|
$
|
(1,774
|
)
|
|
$
|
750
|
|
|
$
|
50
|
|
|
$
|
(500
|
)
|
|
$
|
300
|
|
|
|
17.
|
Summarized
Quarterly Financial Data (Unaudited)
|
Following are summarized quarterly financial data (unaudited)
for the years ended December 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
March 31
|
|
June 30
|
|
September 30
|
|
|
|
|
(Restated)(1)
|
|
(Restated)(1)
|
|
(Restated)(1)
|
|
December 31
|
|
|
(In thousands)
|
|
Total revenue
|
|
$
|
14
|
|
|
$
|
57
|
|
|
$
|
5
|
|
|
$
|
24
|
|
Operating loss
|
|
|
(3,008
|
)
|
|
|
(3,117
|
)
|
|
|
(3,875
|
)
|
|
|
(1,543
|
)
|
Net (loss) income
|
|
|
(17,259
|
)
|
|
|
(31,573
|
)
|
|
|
10,082
|
|
|
|
(18,159
|
)
|
Net (loss) income per share, basic
|
|
$
|
(0.41
|
)
|
|
$
|
(0.73
|
)
|
|
$
|
0.21
|
|
|
$
|
(0.35
|
)
|
Net (loss) income per share, diluted
|
|
$
|
(0.41
|
)
|
|
$
|
(0.73
|
)
|
|
$
|
0.20
|
|
|
$
|
(0.35
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 Restated(1)
|
|
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
|
|
(In thousands)
|
|
Total revenue
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
92
|
|
Operating loss
|
|
|
(4,659
|
)
|
|
|
(2,998
|
)
|
|
|
(3,393
|
)
|
|
|
(3,502
|
)
|
Net loss
|
|
|
(4,381
|
)
|
|
|
(3,103
|
)
|
|
|
(2,907
|
)
|
|
|
(6,430
|
)
|
Net (loss) per share, basic and diluted
|
|
$
|
(0.14
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.15
|
)
|
|
|
|
(1) |
|
For a description of such restatement of the Companys
financial statements see Note 19 (below). |
89
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
In accordance with FASB ASC 820, Fair Value Measurements
and Disclosures, the following table represents the
Companys fair value hierarchy for its financial
liabilities measured at fair value on a recurring basis as of
December 31, 2010:
|
|
|
|
|
|
|
Level 2
|
|
|
|
2010
|
|
|
|
(In thousands)
|
|
|
Derivative instruments (short term)
|
|
$
|
22,940
|
|
Derivative instruments (long term)
|
|
|
11,166
|
|
|
|
|
|
|
Total
|
|
$
|
34,106
|
|
|
|
|
|
|
The derivative instruments were valued using the market
approach, which is considered Level 2 because it uses
inputs other than quoted prices in active markets that are
either directly or indirectly observable. Accordingly, the
derivatives were valued using the Black-Scholes model. See
Note 9 for significant observable inputs used in the
Black-Scholes model.
|
|
19.
|
Restatement
of Previously Issued Financial Statements
|
On March 28, 2011, Management of Emisphere Technologies,
Inc. (the Company), after consulting with the Audit
Committee of the Board of Directors and with McGladrey and
Pullen, LLP (McGladrey), its independent registered
public accounting firm, concluded that the Companys
previously issued financial statements included in its quarterly
interim period reports previously reported on
Forms 10-Q
for the periods ended March 31, June 30, and
September 30, 2009 and 2010, and its annual report on
Form 10-K
for the period ended December 31, 2009 (the Financial
Statement Periods) should no longer be relied upon due to
errors in the application of accounting guidance regarding the
determination of whether a financial instrument is indexed to
its own stock. At the time these financial statements were
originally issued, the Company had reviewed its accounting for
the adoption of Financial Accounting Standards Board Accounting
Codification Topic
815-40-15-5,
Evaluating Whether an Instrument Is Considered Indexed to
an Entitys Own Stock (FASB
815-40-15-5
or the Guidance) and concluded it was in accordance
with GAAP. The Companys adoption of the Guidance was not
straightforward because GAAP specifies the application of a
level interest method to amortize interest and debt discounts in
accordance with FASB
835-30-35-2,
The Interest Method (FASB
835-30-35-2)
. In adopting the guidance, the Company estimated the fair value
of the bifurcated conversion feature embedded in the
Companys 11% senior secured convertible notes in
favor of MHR Institutional Partners IIA due September 26,
2012 (collectively, the MHR Convertible Notes) as a
derivative liability and developed an amortization schedule to
recognize non-cash interest expense and debt discounts over
time. In accordance with the guidance, the Company deducted the
incremental value of the conversion feature from the book value
of the instrument at its inception. Because the fair value of
the conversion feature was in excess of the book value of the
instrument, the Company believed it could not apply a level rate
method to determine the amortization schedule because the
resulting book value would have been $0 and because it is
mathematically impossible to apply a level interest rate to
amortize from a $0 balance. Therefore, the Company developed an
amortization schedule that it believed was consistent with the
adoption of the new accounting guidance and was still
representative of the economic substance of the financial
instrument. This accounting treatment was reflected in the
Companys financial statements during the Financial
Statement Periods.
McGladrey audited the Companys financial statements for
2009. The Companys Audit Committee and Management
discussed the results of the audit including a review of
financial statements for 2009 with McGladrey.
90
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
On March 24, 2011, McGladrey notified the Company that the
amortization schedule described above was not in accordance with
the level rate method required by GAAP and that it should be
recalculated accordingly. McGladrey further notified the Company
that as a result of this error, the financial statements did not
reflect the proper amortization of non-cash interest expense and
debt discounts in connection with the bifurcated conversion
feature embedded in the MHR Convertible Notes as a derivative
liability. McGladrey further notified the Company that it should
make disclosures and take appropriate actions to prevent future
reliance on the financial statements disclosed in the Financial
Statement Periods.
After discussions between Management, the Audit Committee and
McGladrey, the Company reevaluated its accounting for the
adoption of the Guidance and for its assessment of the debt
modification entered into during June 2010 and determined that
its original accounting was incorrect. Consequently, the Company
determined to restate its financial statements for the Financial
Statement Periods. The Company used the level rate method in
accordance with FASB
835-30-35-2
to revise its amortization schedule in accordance with GAAP. The
Company assigned a beginning balance nominally close to $0 to
develop this amortization schedule. The restatements of
financial statements previously reported on
Forms 10-Q
for the periods ended March 31, June 30, and
September 30, 2009 and 2010, and on
Form 10-K
for the period ended December 31, 2009 will reflect
adjustments primarily to correct for the revised amortization
schedule and resulting overstatement of non-cash interest
charges and the recorded value of notes payable, which included
the effects of the accretion of debt discount resulting from the
valuation of the embedded derivative associated with the MHR
Convertible Note. Additionally, after correcting the
misapplication of guidance for determining whether a financial
instrument is indexed to its own stock, the Company reevaluated
its accounting for debt modification in connection with the
Master Agreement and Amendment by and between the Company and
Novartis Pharma AG dated June 4, 2010 and the letter
agreement entered into with MHR in connection therewith and
concluded that modifications to the MHR Convertible Notes should
have been accounted for as extinguishment of debt in accordance
with FASB
ASC 470-50,
Modifications and Extinguishments, which resulted in
a $17.0 million non-cash adjustment to recognize the loss
on extinguishment of debt.
The Company emphasizes that all reclassifications and related
charges to correct the misapplication of the relevant accounting
pronouncement and subsequent debt modification adjustment have
no impact on the Companys operating income, its cash
position, its cash flows or its future cash requirements.
91
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
The tables below summarize the impact of the restatements
described above on financial information previously reported on
the Companys
Forms 10-Q
for the periods ended March 31, June 30, and
September 30, 2009 and 2010 and on
Form 10-K
for the period ended December 2009. The restatement did not
impact cash flow from operating, investing, or financing
activities.
Audited
Financial Statements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restated
|
|
|
|
As Reported
|
|
|
|
|
2009
|
|
Adjustments
|
|
2009
|
|
|
|
|
($thousands, except per share data)
|
|
|
|
BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred financing costs
|
|
$
|
|
|
|
$
|
(346
|
)(1)
|
|
$
|
346
|
|
|
|
|
|
Total assets
|
|
$
|
5,587
|
|
|
$
|
(346
|
)
|
|
$
|
5,933
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable, including accrued interest
|
|
$
|
93
|
|
|
$
|
(12,983
|
)(1)
|
|
$
|
13,076
|
|
|
|
|
|
Total liabilities
|
|
$
|
40,814
|
|
|
$
|
(12,983
|
)
|
|
$
|
53,797
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
$
|
(424,034
|
)
|
|
$
|
12,637
|
(1)
|
|
$
|
(436,671
|
)
|
|
|
|
|
Total stockholders deficit
|
|
$
|
(35,227
|
)
|
|
$
|
12,637
|
|
|
$
|
(47,864
|
)
|
|
|
|
|
STATEMENT OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-operating income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, related party
|
|
$
|
(82
|
)
|
|
$
|
4,422
|
(1)
|
|
$
|
(4,504
|
)
|
|
|
|
|
Total other non-operating income (expense)
|
|
$
|
(2,269
|
)
|
|
$
|
4,422
|
|
|
$
|
(6,691
|
)
|
|
|
|
|
Net loss
|
|
$
|
(16,821
|
)
|
|
$
|
4,422
|
|
|
$
|
(21,243
|
)
|
|
|
|
|
Loss per common share, basic and diluted
|
|
$
|
(0.49
|
)
|
|
$
|
0.12
|
|
|
$
|
(0.61
|
)
|
|
|
|
|
CASH FLOW DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(16,821
|
)
|
|
$
|
4,422
|
|
|
$
|
(21,243
|
)
|
|
|
|
|
Non-cash interest expense related party
|
|
$
|
82
|
|
|
$
|
(4,422
|
)
|
|
$
|
4,504
|
|
|
|
|
|
Net cash used in operating activities
|
|
$
|
(11,931
|
)
|
|
$
|
|
|
|
$
|
(11,931
|
)
|
|
|
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
92
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
2009
Balance Sheets (unaudited $thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
3,951
|
|
|
|
|
|
|
|
3,951
|
|
|
|
1,279
|
|
|
|
|
|
|
|
1,279
|
|
|
|
6,975
|
|
|
|
|
|
|
|
6,975
|
|
Accounts receivable, net
|
|
|
15
|
|
|
|
|
|
|
|
15
|
|
|
|
72
|
|
|
|
|
|
|
|
72
|
|
|
|
21
|
|
|
|
|
|
|
|
21
|
|
Prepaid expenses and other current assets
|
|
|
300
|
|
|
|
|
|
|
|
300
|
|
|
|
402
|
|
|
|
|
|
|
|
402
|
|
|
|
253
|
|
|
|
|
|
|
|
253
|
|
Total current assets
|
|
|
4,266
|
|
|
|
|
|
|
|
4,266
|
|
|
|
1,753
|
|
|
|
|
|
|
|
1,753
|
|
|
|
7,249
|
|
|
|
|
|
|
|
7,249
|
|
Equipment and leasehold improvements, net
|
|
|
312
|
|
|
|
|
|
|
|
312
|
|
|
|
244
|
|
|
|
|
|
|
|
244
|
|
|
|
161
|
|
|
|
|
|
|
|
161
|
|
Purchased technology, net
|
|
|
1,256
|
|
|
|
|
|
|
|
1,256
|
|
|
|
1,196
|
|
|
|
|
|
|
|
1,196
|
|
|
|
1,137
|
|
|
|
|
|
|
|
1,137
|
|
Restricted cash
|
|
|
255
|
|
|
|
|
|
|
|
255
|
|
|
|
255
|
|
|
|
|
|
|
|
255
|
|
|
|
255
|
|
|
|
|
|
|
|
255
|
|
Other assets(1)
|
|
|
|
|
|
|
(404
|
)
|
|
|
404
|
|
|
|
|
|
|
|
(386
|
)
|
|
|
386
|
|
|
|
|
|
|
|
(367
|
)
|
|
|
367
|
|
Total assets
|
|
|
6,089
|
|
|
|
(404
|
)
|
|
|
6,493
|
|
|
|
3,448
|
|
|
|
(386
|
)
|
|
|
3,834
|
|
|
|
8,802
|
|
|
|
(367
|
)
|
|
|
9,169
|
|
Liabilities and Stockholders Deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable, including accrued interest and net of related
discount
|
|
|
12,146
|
|
|
|
|
|
|
|
12,146
|
|
|
|
12,283
|
|
|
|
|
|
|
|
12,283
|
|
|
|
12,422
|
|
|
|
|
|
|
|
12,422
|
|
Accounts payable and accrued expenses
|
|
|
3,288
|
|
|
|
|
|
|
|
3,288
|
|
|
|
3,403
|
|
|
|
|
|
|
|
3,403
|
|
|
|
4,511
|
|
|
|
|
|
|
|
4,511
|
|
Deferred revenue, current
|
|
|
110
|
|
|
|
|
|
|
|
110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
|
|
|
|
|
|
9
|
|
Derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
173
|
|
|
|
|
|
|
|
173
|
|
|
|
337
|
|
|
|
|
|
|
|
337
|
|
|
|
2,179
|
|
|
|
|
|
|
|
2,179
|
|
Others
|
|
|
268
|
|
|
|
|
|
|
|
268
|
|
|
|
557
|
|
|
|
|
|
|
|
557
|
|
|
|
2,042
|
|
|
|
|
|
|
|
2,042
|
|
Restructuring accrual, current
|
|
|
1,503
|
|
|
|
|
|
|
|
1,503
|
|
|
|
1,253
|
|
|
|
|
|
|
|
1,253
|
|
|
|
1,253
|
|
|
|
|
|
|
|
1,253
|
|
Other current liabilities
|
|
|
22
|
|
|
|
|
|
|
|
22
|
|
|
|
48
|
|
|
|
|
|
|
|
48
|
|
|
|
51
|
|
|
|
|
|
|
|
51
|
|
Total current liabilities
|
|
|
17,510
|
|
|
|
|
|
|
|
17,510
|
|
|
|
17,881
|
|
|
|
|
|
|
|
17,881
|
|
|
|
22,467
|
|
|
|
|
|
|
|
22,467
|
|
Notes payable, including accrued interest and net of related
discount
|
|
|
19
|
|
|
|
(9,655
|
)
|
|
|
9,674
|
|
|
|
32
|
|
|
|
(10,721
|
)
|
|
|
10,753
|
|
|
|
52
|
|
|
|
(11,831
|
)
|
|
|
11,883
|
|
Restructuring accrual
|
|
|
750
|
|
|
|
|
|
|
|
750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
|
11,403
|
|
|
|
|
|
|
|
11,403
|
|
|
|
11,460
|
|
|
|
|
|
|
|
11,460
|
|
|
|
11,467
|
|
|
|
|
|
|
|
11,467
|
|
Derivative instrument related party
|
|
|
3,194
|
|
|
|
|
|
|
|
3,194
|
|
|
|
3,224
|
|
|
|
|
|
|
|
3,224
|
|
|
|
3,800
|
|
|
|
|
|
|
|
3,800
|
|
Deferred lease liability and other liabilities
|
|
|
123
|
|
|
|
|
|
|
|
123
|
|
|
|
96
|
|
|
|
|
|
|
|
96
|
|
|
|
90
|
|
|
|
|
|
|
|
90
|
|
Total liabilities
|
|
|
32,999
|
|
|
|
(9,655
|
)
|
|
|
42,654
|
|
|
|
32,693
|
|
|
|
(10,721
|
)
|
|
|
43,414
|
|
|
|
37,876
|
|
|
|
(11,831
|
)
|
|
|
49,707
|
|
Stockholders deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value; authorized
1,000,000 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $.01 par value; authorized
100,000,000 shares; issued 30,630,810 shares
(30,341,078 outstanding) ; issued 30,630,810 (30,341,078
outstanding); issued 42,360,133 (42,070,401 outstanding) in the
first, second and third quarter , respectively
|
|
|
306
|
|
|
|
|
|
|
|
306
|
|
|
|
306
|
|
|
|
|
|
|
|
306
|
|
|
|
424
|
|
|
|
|
|
|
|
424
|
|
Additional
paid-in-capital
|
|
|
388,330
|
|
|
|
|
|
|
|
388,330
|
|
|
|
389,098
|
|
|
|
|
|
|
|
389,098
|
|
|
|
392,059
|
|
|
|
|
|
|
|
392,059
|
|
Accumulated deficit
|
|
|
(411,594
|
)
|
|
|
9,251
|
|
|
|
(420,845
|
)
|
|
|
(414,697
|
)
|
|
|
10,335
|
|
|
|
(425,032
|
)
|
|
|
(417,605
|
)
|
|
|
11,464
|
|
|
|
(429,069
|
)
|
Common stock held in treasury, at cost; 289,732 shares
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
Total stockholders deficit
|
|
|
(26,910
|
)
|
|
|
9,251
|
|
|
|
(36,161
|
)
|
|
|
(29,245
|
)
|
|
|
10,335
|
|
|
|
(39,580
|
)
|
|
|
(29,074
|
)
|
|
|
11,464
|
|
|
|
(40,538
|
)
|
Total liabilities and stockholders deficit
|
|
|
6,089
|
|
|
|
(404
|
)
|
|
|
6,493
|
|
|
|
3,448
|
|
|
|
(386
|
)
|
|
|
3,834
|
|
|
|
8,802
|
|
|
|
(367
|
)
|
|
|
9,169
|
|
93
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
2009
Statements of Operations Quarterly
(unaudited $thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Three Months Ended June 30,
|
|
Three Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,923
|
|
|
|
|
|
|
|
1,923
|
|
|
|
748
|
|
|
|
|
|
|
|
748
|
|
|
|
782
|
|
|
|
|
|
|
|
782
|
|
General and administrative expenses
|
|
|
2,921
|
|
|
|
|
|
|
|
2,921
|
|
|
|
2,933
|
|
|
|
|
|
|
|
2,933
|
|
|
|
2,493
|
|
|
|
|
|
|
|
2,493
|
|
Restructuring costs
|
|
|
(353
|
)
|
|
|
|
|
|
|
(353
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on disposal of fixed assets
|
|
|
(43
|
)
|
|
|
|
|
|
|
(43
|
)
|
|
|
(779
|
)
|
|
|
|
|
|
|
(779
|
)
|
|
|
(2
|
)
|
|
|
|
|
|
|
(2
|
)
|
Depreciation and amortization
|
|
|
211
|
|
|
|
|
|
|
|
211
|
|
|
|
96
|
|
|
|
|
|
|
|
96
|
|
|
|
120
|
|
|
|
|
|
|
|
120
|
|
Total costs and expenses
|
|
|
4,659
|
|
|
|
|
|
|
|
4,659
|
|
|
|
2,998
|
|
|
|
|
|
|
|
2,998
|
|
|
|
3,393
|
|
|
|
|
|
|
|
3,393
|
|
Operating income (loss)
|
|
|
(4,659
|
)
|
|
|
|
|
|
|
(4,659
|
)
|
|
|
(2,998
|
)
|
|
|
|
|
|
|
(2,998
|
)
|
|
|
(3,393
|
)
|
|
|
|
|
|
|
(3,393
|
)
|
Other non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
41
|
|
|
|
|
|
|
|
41
|
|
|
|
27
|
|
|
|
|
|
|
|
27
|
|
|
|
24
|
|
|
|
|
|
|
|
24
|
|
Sublease income
|
|
|
232
|
|
|
|
|
|
|
|
232
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of patents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party(1)
|
|
|
113
|
|
|
|
|
|
|
|
113
|
|
|
|
(193
|
)
|
|
|
|
|
|
|
(193
|
)
|
|
|
45
|
|
|
|
|
|
|
|
45
|
|
Other
|
|
|
35
|
|
|
|
|
|
|
|
35
|
|
|
|
(289
|
)
|
|
|
|
|
|
|
(289
|
)
|
|
|
576
|
|
|
|
|
|
|
|
576
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(8
|
)
|
|
|
1,036
|
|
|
|
(1,044
|
)
|
|
|
(13
|
)
|
|
|
1,084
|
|
|
|
(1,097
|
)
|
|
|
(20
|
)
|
|
|
1,130
|
|
|
|
(1,150
|
)
|
Other
|
|
|
(135
|
)
|
|
|
|
|
|
|
(135
|
)
|
|
|
(137
|
)
|
|
|
|
|
|
|
(137
|
)
|
|
|
(139
|
)
|
|
|
|
|
|
|
(139
|
)
|
Total other non-operating income (expense)
|
|
|
278
|
|
|
|
1,036
|
|
|
|
(758
|
)
|
|
|
(105
|
)
|
|
|
1,084
|
|
|
|
(1,189
|
)
|
|
|
486
|
|
|
|
1,130
|
|
|
|
(644
|
)
|
Net loss
|
|
|
(4,381
|
)
|
|
|
1,036
|
|
|
|
(5,417
|
)
|
|
|
(3,103
|
)
|
|
|
1,084
|
|
|
|
(4,187
|
)
|
|
|
(2,907
|
)
|
|
|
1,130
|
|
|
|
(4,037
|
)
|
Net loss per share, basic and diluted
|
|
|
(0.14
|
)
|
|
|
0.04
|
|
|
|
(0.18
|
)
|
|
|
(0.10
|
)
|
|
|
0.04
|
|
|
|
(0.14
|
)
|
|
|
(0.08
|
)
|
|
|
0.03
|
|
|
|
(0.11
|
)
|
Weighted average shares outstanding, basic and diluted
|
|
|
30,341,078
|
|
|
|
|
|
|
|
30,341,078
|
|
|
|
30,341,078
|
|
|
|
|
|
|
|
30,341,078
|
|
|
|
35,695,769
|
|
|
|
|
|
|
|
35,695,769
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
94
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
2009
Statements of Operations Year to Date
(unaudited $thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Three Months Ended June 30,
|
|
Three Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,923
|
|
|
|
|
|
|
|
1,923
|
|
|
|
2,670
|
|
|
|
|
|
|
|
2,670
|
|
|
|
3,452
|
|
|
|
|
|
|
|
3,452
|
|
General and administrative expenses
|
|
|
2,921
|
|
|
|
|
|
|
|
2,921
|
|
|
|
5,855
|
|
|
|
|
|
|
|
5,855
|
|
|
|
8,348
|
|
|
|
|
|
|
|
8,348
|
|
Restructuring costs
|
|
|
(353
|
)
|
|
|
|
|
|
|
(353
|
)
|
|
|
(353
|
)
|
|
|
|
|
|
|
(353
|
)
|
|
|
(353
|
)
|
|
|
|
|
|
|
(353
|
)
|
Gain on disposal of fixed assets
|
|
|
(43
|
)
|
|
|
|
|
|
|
(43
|
)
|
|
|
(822
|
)
|
|
|
|
|
|
|
(822
|
)
|
|
|
(824
|
)
|
|
|
|
|
|
|
(824
|
)
|
Depreciation and amortization
|
|
|
211
|
|
|
|
|
|
|
|
211
|
|
|
|
307
|
|
|
|
|
|
|
|
307
|
|
|
|
427
|
|
|
|
|
|
|
|
427
|
|
Total costs and expenses
|
|
|
4,659
|
|
|
|
|
|
|
|
4,659
|
|
|
|
7,657
|
|
|
|
|
|
|
|
7,657
|
|
|
|
11,050
|
|
|
|
|
|
|
|
11,050
|
|
Operating income (loss)
|
|
|
(4,659
|
)
|
|
|
|
|
|
|
(4,659
|
)
|
|
|
(7,657
|
)
|
|
|
|
|
|
|
(7,657
|
)
|
|
|
(11,050
|
)
|
|
|
|
|
|
|
(11,050
|
)
|
Other non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
41
|
|
|
|
|
|
|
|
41
|
|
|
|
68
|
|
|
|
|
|
|
|
68
|
|
|
|
91
|
|
|
|
|
|
|
|
91
|
|
Sublease income
|
|
|
232
|
|
|
|
|
|
|
|
232
|
|
|
|
232
|
|
|
|
|
|
|
|
232
|
|
|
|
232
|
|
|
|
|
|
|
|
232
|
|
Sale of patents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
Change in fair value of derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party(1)
|
|
|
113
|
|
|
|
|
|
|
|
113
|
|
|
|
(80
|
)
|
|
|
|
|
|
|
(80
|
)
|
|
|
(35
|
)
|
|
|
|
|
|
|
(35
|
)
|
Other
|
|
|
35
|
|
|
|
|
|
|
|
35
|
|
|
|
(254
|
)
|
|
|
|
|
|
|
(254
|
)
|
|
|
322
|
|
|
|
|
|
|
|
322
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(8
|
)
|
|
|
1,036
|
|
|
|
(1,044
|
)
|
|
|
(21
|
)
|
|
|
2,119
|
|
|
|
(2,140
|
)
|
|
|
(41
|
)
|
|
|
3,249
|
|
|
|
(3,290
|
)
|
Other
|
|
|
(135
|
)
|
|
|
|
|
|
|
(135
|
)
|
|
|
(273
|
)
|
|
|
|
|
|
|
(273
|
)
|
|
|
(411
|
)
|
|
|
|
|
|
|
(411
|
)
|
Total other non-operating income (expense)
|
|
|
278
|
|
|
|
1,036
|
|
|
|
(758
|
)
|
|
|
172
|
|
|
|
2,119
|
|
|
|
(1,947
|
)
|
|
|
658
|
|
|
|
3,249
|
|
|
|
(2,591
|
)
|
Net loss
|
|
|
(4,381
|
)
|
|
|
1,036
|
|
|
|
(5,417
|
)
|
|
|
(7,485
|
)
|
|
|
2,119
|
|
|
|
(9,604
|
)
|
|
|
(10,392
|
)
|
|
|
3,249
|
|
|
|
(13,641
|
)
|
Net loss per share, basic and diluted
|
|
|
(0.14
|
)
|
|
|
0.04
|
|
|
|
(0.18
|
)
|
|
|
(0.25
|
)
|
|
|
0.07
|
|
|
|
(0.32
|
)
|
|
|
(0.32
|
)
|
|
|
0.10
|
|
|
|
(0.42
|
)
|
Weighted average shares outstanding, basic and diluted
|
|
|
30,341,078
|
|
|
|
|
|
|
|
30,341,078
|
|
|
|
30,341,078
|
|
|
|
|
|
|
|
30,341,078
|
|
|
|
32,188,554
|
|
|
|
|
|
|
|
32,188,554
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
95
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
2009
Statements of Cash Flows (unaudited
$thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Six Months Ended June 30,
|
|
Nine Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
2009
|
|
Adjustments
|
|
2009
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(4,381
|
)
|
|
|
1,036
|
|
|
|
(5,417
|
)
|
|
|
(7,485
|
)
|
|
|
2,119
|
|
|
|
(9,604
|
)
|
|
|
(10,392
|
)
|
|
|
3,249
|
|
|
|
(13,641
|
)
|
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
151
|
|
|
|
|
|
|
|
151
|
|
|
|
187
|
|
|
|
|
|
|
|
187
|
|
|
|
248
|
|
|
|
|
|
|
|
248
|
|
Amortization
|
|
|
60
|
|
|
|
|
|
|
|
60
|
|
|
|
120
|
|
|
|
|
|
|
|
120
|
|
|
|
179
|
|
|
|
|
|
|
|
179
|
|
Change in fair value of derivative instruments
|
|
|
(148
|
)
|
|
|
|
|
|
|
(148
|
)
|
|
|
334
|
|
|
|
|
|
|
|
334
|
|
|
|
(286
|
)
|
|
|
|
|
|
|
(286
|
)
|
Non-cash interest expense(1)
|
|
|
143
|
|
|
|
(1,036
|
)
|
|
|
1,179
|
|
|
|
294
|
|
|
|
(2,119
|
)
|
|
|
2,413
|
|
|
|
452
|
|
|
|
(3,249
|
)
|
|
|
3,701
|
|
Non-cash compensation expense
|
|
|
238
|
|
|
|
|
|
|
|
238
|
|
|
|
1,007
|
|
|
|
|
|
|
|
1,007
|
|
|
|
1,301
|
|
|
|
|
|
|
|
1,301
|
|
Gain on disposal of fixed assets
|
|
|
(43
|
)
|
|
|
|
|
|
|
(43
|
)
|
|
|
(822
|
)
|
|
|
|
|
|
|
(822
|
)
|
|
|
(824
|
)
|
|
|
|
|
|
|
(824
|
)
|
Changes in assets and liabilities excluding non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in accounts receivable
|
|
|
217
|
|
|
|
|
|
|
|
217
|
|
|
|
160
|
|
|
|
|
|
|
|
160
|
|
|
|
211
|
|
|
|
|
|
|
|
211
|
|
Decrease (increase) in prepaid expenses and other current assets
|
|
|
(27
|
)
|
|
|
|
|
|
|
(27
|
)
|
|
|
(129
|
)
|
|
|
|
|
|
|
(129
|
)
|
|
|
20
|
|
|
|
|
|
|
|
20
|
|
Increase in deferred revenue
|
|
|
186
|
|
|
|
|
|
|
|
186
|
|
|
|
133
|
|
|
|
|
|
|
|
133
|
|
|
|
149
|
|
|
|
|
|
|
|
149
|
|
Increase in accounts payable and accrued expenses
|
|
|
927
|
|
|
|
|
|
|
|
927
|
|
|
|
1,042
|
|
|
|
|
|
|
|
1,042
|
|
|
|
2,160
|
|
|
|
|
|
|
|
2,160
|
|
Increase in other current liabilities
|
|
|
2
|
|
|
|
|
|
|
|
2
|
|
|
|
28
|
|
|
|
|
|
|
|
28
|
|
|
|
31
|
|
|
|
|
|
|
|
31
|
|
(Decrease) in deferred lease liability
|
|
|
(6
|
)
|
|
|
|
|
|
|
(6
|
)
|
|
|
(33
|
)
|
|
|
|
|
|
|
(33
|
)
|
|
|
(39
|
)
|
|
|
|
|
|
|
(39
|
)
|
Decrease in restructuring accrual
|
|
|
(627
|
)
|
|
|
|
|
|
|
(627
|
)
|
|
|
(1,627
|
)
|
|
|
|
|
|
|
(1,627
|
)
|
|
|
(1,627
|
)
|
|
|
|
|
|
|
(1,627
|
)
|
Total adjustments
|
|
|
1,073
|
|
|
|
(1,036
|
)
|
|
|
2,109
|
|
|
|
694
|
|
|
|
(2,119
|
)
|
|
|
2,813
|
|
|
|
1,975
|
|
|
|
(3,249
|
)
|
|
|
5,224
|
|
Net cash used in operating activities
|
|
|
(3,308
|
)
|
|
|
|
|
|
|
(3,308
|
)
|
|
|
(6,791
|
)
|
|
|
|
|
|
|
(6,791
|
)
|
|
|
(8,417
|
)
|
|
|
|
|
|
|
(8,417
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale and maturity of investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of fixed assets
|
|
|
45
|
|
|
|
|
|
|
|
45
|
|
|
|
856
|
|
|
|
|
|
|
|
856
|
|
|
|
880
|
|
|
|
|
|
|
|
880
|
|
Capital expenditures and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
45
|
|
|
|
|
|
|
|
45
|
|
|
|
856
|
|
|
|
|
|
|
|
856
|
|
|
|
880
|
|
|
|
|
|
|
|
880
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock and warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,298
|
|
|
|
|
|
|
|
7,298
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,298
|
|
|
|
|
|
|
|
7,298
|
|
Net decrease in cash and cash equivalents
|
|
|
(3,263
|
)
|
|
|
|
|
|
|
(3,263
|
)
|
|
|
(5,935
|
)
|
|
|
|
|
|
|
(5,935
|
)
|
|
|
(239
|
)
|
|
|
|
|
|
|
(239
|
)
|
Cash and cash equivalents, beginning of period
|
|
|
7,214
|
|
|
|
|
|
|
|
7,214
|
|
|
|
7,214
|
|
|
|
|
|
|
|
7,214
|
|
|
|
7,214
|
|
|
|
|
|
|
|
7,214
|
|
Cash and cash equivalents, end of period
|
|
|
3,951
|
|
|
|
|
|
|
|
3,951
|
|
|
|
1,279
|
|
|
|
|
|
|
|
1,279
|
|
|
|
6,975
|
|
|
|
|
|
|
|
6,975
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
96
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
2010
Balance Sheets (unaudited $thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
3,015
|
|
|
|
|
|
|
|
3,015
|
|
|
|
418
|
|
|
|
|
|
|
|
418
|
|
|
|
2,961
|
|
|
|
|
|
|
|
2,961
|
|
Accounts receivable, net
|
|
|
4
|
|
|
|
|
|
|
|
4
|
|
|
|
38
|
|
|
|
|
|
|
|
38
|
|
|
|
60
|
|
|
|
|
|
|
|
60
|
|
Inventories
|
|
|
233
|
|
|
|
|
|
|
|
233
|
|
|
|
261
|
|
|
|
|
|
|
|
261
|
|
|
|
260
|
|
|
|
|
|
|
|
260
|
|
Prepaid expenses and other current assets
|
|
|
142
|
|
|
|
|
|
|
|
142
|
|
|
|
683
|
|
|
|
|
|
|
|
683
|
|
|
|
539
|
|
|
|
|
|
|
|
539
|
|
Total current assets
|
|
|
3,394
|
|
|
|
|
|
|
|
3,394
|
|
|
|
1,400
|
|
|
|
|
|
|
|
1,400
|
|
|
|
3,820
|
|
|
|
|
|
|
|
3,820
|
|
Equipment and leasehold improvements, net
|
|
|
122
|
|
|
|
|
|
|
|
122
|
|
|
|
107
|
|
|
|
|
|
|
|
107
|
|
|
|
94
|
|
|
|
|
|
|
|
94
|
|
Purchased technology, net
|
|
|
1,017
|
|
|
|
|
|
|
|
1,017
|
|
|
|
957
|
|
|
|
|
|
|
|
957
|
|
|
|
897
|
|
|
|
|
|
|
|
897
|
|
Restricted cash
|
|
|
259
|
|
|
|
|
|
|
|
259
|
|
|
|
259
|
|
|
|
|
|
|
|
259
|
|
|
|
259
|
|
|
|
|
|
|
|
259
|
|
Other assets(1)
|
|
|
|
|
|
|
(324
|
)
|
|
|
324
|
|
|
|
82
|
|
|
|
(300
|
)
|
|
|
382
|
|
|
|
|
|
|
|
(273
|
)
|
|
|
273
|
|
Total assets
|
|
|
4,792
|
|
|
|
(324
|
)
|
|
|
5,116
|
|
|
|
2,805
|
|
|
|
(300
|
)
|
|
|
3,105
|
|
|
|
5,070
|
|
|
|
(273
|
)
|
|
|
5,343
|
|
Liabilities and Stockholders Deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable, including accrued interest and net of related
discount
|
|
|
12,810
|
|
|
|
|
|
|
|
12,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
4,943
|
|
|
|
|
|
|
|
4,943
|
|
|
|
5,852
|
|
|
|
|
|
|
|
5,852
|
|
|
|
4,400
|
|
|
|
|
|
|
|
4,400
|
|
Deferred revenue, current
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
8,248
|
|
|
|
|
|
|
|
8,248
|
|
|
|
12,952
|
|
|
|
|
|
|
|
12,952
|
|
|
|
7,477
|
|
|
|
|
|
|
|
7,477
|
|
Others
|
|
|
7,830
|
|
|
|
|
|
|
|
7,830
|
|
|
|
4,183
|
|
|
|
|
|
|
|
4,183
|
|
|
|
2,423
|
|
|
|
|
|
|
|
2,423
|
|
Contract termination expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
435
|
|
|
|
|
|
|
|
435
|
|
Restructuring accrual, current
|
|
|
600
|
|
|
|
|
|
|
|
600
|
|
|
|
600
|
|
|
|
|
|
|
|
600
|
|
|
|
450
|
|
|
|
|
|
|
|
450
|
|
Other current liabilities
|
|
|
29
|
|
|
|
|
|
|
|
29
|
|
|
|
31
|
|
|
|
|
|
|
|
31
|
|
|
|
33
|
|
|
|
|
|
|
|
33
|
|
Total current liabilities
|
|
|
34,460
|
|
|
|
|
|
|
|
34,460
|
|
|
|
23,618
|
|
|
|
|
|
|
|
23,618
|
|
|
|
15,218
|
|
|
|
|
|
|
|
15,218
|
|
Notes payable, including accrued interest and net of related
discount(1)(2)
|
|
|
157
|
|
|
|
(14,167
|
)
|
|
|
14,324
|
|
|
|
18,048
|
|
|
|
3,726
|
|
|
|
14,322
|
|
|
|
19,181
|
|
|
|
3,318
|
|
|
|
15,863
|
|
Restructuring accrual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue
|
|
|
13,501
|
|
|
|
|
|
|
|
13,501
|
|
|
|
26,475
|
|
|
|
|
|
|
|
26,475
|
|
|
|
26,533
|
|
|
|
|
|
|
|
26,533
|
|
Derivative instrument related party
|
|
|
8,669
|
|
|
|
|
|
|
|
8,669
|
|
|
|
12,031
|
|
|
|
|
|
|
|
12,031
|
|
|
|
8,557
|
|
|
|
|
|
|
|
8,557
|
|
Deferred lease liability and other liabilities
|
|
|
74
|
|
|
|
|
|
|
|
74
|
|
|
|
65
|
|
|
|
|
|
|
|
65
|
|
|
|
56
|
|
|
|
|
|
|
|
56
|
|
Total liabilities
|
|
|
56,861
|
|
|
|
(14,167
|
)
|
|
|
71,028
|
|
|
|
80,237
|
|
|
|
3,726
|
|
|
|
76,511
|
|
|
|
69,545
|
|
|
|
3,318
|
|
|
|
66,227
|
|
Stockholders deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value; authorized
1,000,000 shares; none issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $.01 par value; authorized
100,000,000 shares; issued 42,373,807 shares
(42,804,075 outstanding) ; issued 44,222,054 (43,932,322
outstanding); issued 52,178,834 (51,889,102 outstanding) in the
first, second and third quarter, respectively
|
|
|
424
|
|
|
|
|
|
|
|
424
|
|
|
|
442
|
|
|
|
|
|
|
|
442
|
|
|
|
522
|
|
|
|
|
|
|
|
522
|
|
Additional
paid-in-capital
|
|
|
392,753
|
|
|
|
|
|
|
|
392,753
|
|
|
|
398,945
|
|
|
|
|
|
|
|
398,945
|
|
|
|
401,740
|
|
|
|
|
|
|
|
401,740
|
|
Accumulated deficit(1)(2)
|
|
|
(441,294
|
)
|
|
|
13,843
|
|
|
|
(455,137
|
)
|
|
|
(472,867
|
)
|
|
|
(4,026
|
)
|
|
|
(468,841
|
)
|
|
|
(462,785
|
)
|
|
|
(3,591
|
)
|
|
|
(459,194
|
)
|
Common stock held in treasury, at cost; 289,732 shares
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
|
|
(3,952
|
)
|
|
|
|
|
|
|
(3,952
|
)
|
Total stockholders deficit
|
|
|
(52,069
|
)
|
|
|
13,843
|
|
|
|
(65,912
|
)
|
|
|
(77,432
|
)
|
|
|
(4,026
|
)
|
|
|
(73,406
|
)
|
|
|
(64,475
|
)
|
|
|
(3,591
|
)
|
|
|
(60,884
|
)
|
Total liabilities and stockholders deficit
|
|
|
4,792
|
|
|
|
(324
|
)
|
|
|
5,116
|
|
|
|
2,805
|
|
|
|
(300
|
)
|
|
|
3,105
|
|
|
|
5,070
|
|
|
|
(273
|
)
|
|
|
5,343
|
|
97
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
|
(2) |
|
Adjustment for June 2010 to account for the modification of the
MHR Convertible Notes in connection with the Novartis Agreement
and the MHR Letter Agreement as an extinguishment of debt and
record the consideration for MHRs consent as a financing
fee |
2010
Statement of Operations Quarterly
(unaudited $thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Three Months Ended June 30,
|
|
Three Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
Revenue
|
|
|
12
|
|
|
|
|
|
|
|
12
|
|
|
|
39
|
|
|
|
|
|
|
|
39
|
|
|
|
4
|
|
|
|
|
|
|
|
4
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
562
|
|
|
|
|
|
|
|
562
|
|
|
|
732
|
|
|
|
|
|
|
|
732
|
|
|
|
690
|
|
|
|
|
|
|
|
690
|
|
General and administrative expenses
|
|
|
2,334
|
|
|
|
|
|
|
|
2,334
|
|
|
|
2,129
|
|
|
|
|
|
|
|
2,129
|
|
|
|
2,516
|
|
|
|
|
|
|
|
2,516
|
|
Restructuring costs
|
|
|
50
|
|
|
|
|
|
|
|
50
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on disposal of fixed assets
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
75
|
|
|
|
|
|
|
|
75
|
|
|
|
75
|
|
|
|
|
|
|
|
75
|
|
|
|
73
|
|
|
|
|
|
|
|
73
|
|
Lawsuit adverse awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
220
|
|
|
|
|
|
|
|
220
|
|
|
|
58
|
|
|
|
|
|
|
|
58
|
|
Contract termination expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
542
|
|
|
|
|
|
|
|
542
|
|
Total costs and expenses
|
|
|
3,020
|
|
|
|
|
|
|
|
3,020
|
|
|
|
3,156
|
|
|
|
|
|
|
|
3,156
|
|
|
|
3,879
|
|
|
|
|
|
|
|
3,879
|
|
Operating income (loss)
|
|
|
(3,008
|
)
|
|
|
|
|
|
|
(3,008
|
)
|
|
|
(3,117
|
)
|
|
|
|
|
|
|
(3,117
|
)
|
|
|
(3,875
|
)
|
|
|
|
|
|
|
(3,875
|
)
|
Other non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
3
|
|
|
|
|
|
|
|
3
|
|
|
|
2
|
|
|
|
|
|
|
|
2
|
|
|
|
2
|
|
|
|
|
|
|
|
2
|
|
Sublease income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of patents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
Change in fair value of derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(9,120
|
)
|
|
|
|
|
|
|
(9,120
|
)
|
|
|
(6,208
|
)
|
|
|
|
|
|
|
(6,208
|
)
|
|
|
11,766
|
|
|
|
|
|
|
|
11,766
|
|
Other
|
|
|
(4,847
|
)
|
|
|
|
|
|
|
(4,847
|
)
|
|
|
(2,424
|
)
|
|
|
|
|
|
|
(2,424
|
)
|
|
|
2,831
|
|
|
|
|
|
|
|
2,831
|
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party(1)
|
|
|
(65
|
)
|
|
|
1,206
|
|
|
|
(1,271
|
)
|
|
|
(794
|
)
|
|
|
1,003
|
|
|
|
(1,797
|
)
|
|
|
(1,138
|
)
|
|
|
435
|
|
|
|
(1,573
|
)
|
Other
|
|
|
(222
|
)
|
|
|
|
|
|
|
(222
|
)
|
|
|
(160
|
)
|
|
|
|
|
|
|
(160
|
)
|
|
|
(4
|
)
|
|
|
|
|
|
|
(4
|
)
|
Loss on extinguishment of debt(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,014
|
)
|
|
|
(17,014
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,858
|
)
|
|
|
(1,858
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other non-operating income (expense)
|
|
|
(14,251
|
)
|
|
|
1,206
|
|
|
|
(15,457
|
)
|
|
|
(28,456
|
)
|
|
|
(17,869
|
)
|
|
|
(10,587
|
)
|
|
|
13,957
|
|
|
|
435
|
|
|
|
13,522
|
|
Net loss (income)
|
|
|
(17,259
|
)
|
|
|
1,206
|
|
|
|
(18,465
|
)
|
|
|
(31,573
|
)
|
|
|
(17,869
|
)
|
|
|
(13,704
|
)
|
|
|
10,082
|
|
|
|
435
|
|
|
|
9,647
|
|
Net loss (income) per share, basic
|
|
|
(0.41
|
)
|
|
|
0.03
|
|
|
|
(0.44
|
)
|
|
|
(0.73
|
)
|
|
|
(0.41
|
)
|
|
|
(0.32
|
)
|
|
|
0.21
|
|
|
|
0.01
|
|
|
|
0.20
|
|
Weighted average shares outstanding, basic
|
|
|
42,077,334
|
|
|
|
|
|
|
|
42,077,334
|
|
|
|
43,338,432
|
|
|
|
|
|
|
|
43,338,432
|
|
|
|
47,401,395
|
|
|
|
|
|
|
|
47,401,395
|
|
Net loss (income) per share, diluted
|
|
|
(0.41
|
)
|
|
|
0.03
|
|
|
|
(0.44
|
)
|
|
|
(0.73
|
)
|
|
|
(0.41
|
)
|
|
|
(0.32
|
)
|
|
|
0.20
|
|
|
|
0.01
|
|
|
|
0.19
|
|
Weighted average shares outstanding, diluted
|
|
|
42,077,334
|
|
|
|
|
|
|
|
42,077,334
|
|
|
|
43,338,432
|
|
|
|
|
|
|
|
43,338,432
|
|
|
|
50,922,881
|
|
|
|
|
|
|
|
50,922,881
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
98
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
|
(2) |
|
Adjustment for June 2010 to account for the modification of the
MHR Convertible Notes in connection with the Novartis Agreement
and the MHR Letter Agreement as an extinguishment of debt and
record the consideration for MHRs consent as a financing
fee |
2010
Statement of Operations Year to Date
(unaudited $thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Six Months Ended June 30,
|
|
Nine Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
Revenue
|
|
|
12
|
|
|
|
|
|
|
|
12
|
|
|
|
51
|
|
|
|
|
|
|
|
51
|
|
|
|
55
|
|
|
|
|
|
|
|
55
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
562
|
|
|
|
|
|
|
|
562
|
|
|
|
1,294
|
|
|
|
|
|
|
|
1,294
|
|
|
|
1,984
|
|
|
|
|
|
|
|
1,984
|
|
General and administrative expenses
|
|
|
2,334
|
|
|
|
|
|
|
|
2,334
|
|
|
|
4,463
|
|
|
|
|
|
|
|
4,463
|
|
|
|
6,979
|
|
|
|
|
|
|
|
6,979
|
|
Restructuring costs
|
|
|
50
|
|
|
|
|
|
|
|
50
|
|
|
|
50
|
|
|
|
|
|
|
|
50
|
|
|
|
50
|
|
|
|
|
|
|
|
50
|
|
Gain on disposal of fixed assets
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
Depreciation and amortization
|
|
|
75
|
|
|
|
|
|
|
|
75
|
|
|
|
150
|
|
|
|
|
|
|
|
150
|
|
|
|
223
|
|
|
|
|
|
|
|
223
|
|
Lawsuit adverse awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
220
|
|
|
|
|
|
|
|
220
|
|
|
|
542
|
|
|
|
|
|
|
|
542
|
|
Contract termination expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
278
|
|
|
|
|
|
|
|
278
|
|
Total costs and expenses
|
|
|
3,020
|
|
|
|
|
|
|
|
3,020
|
|
|
|
6,176
|
|
|
|
|
|
|
|
6,176
|
|
|
|
10,055
|
|
|
|
|
|
|
|
10,055
|
|
Operating income (loss)
|
|
|
(3,008
|
)
|
|
|
|
|
|
|
(3,008
|
)
|
|
|
(6,125
|
)
|
|
|
|
|
|
|
(6,125
|
)
|
|
|
(10,000
|
)
|
|
|
|
|
|
|
(10,000
|
)
|
Other non-operating income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
3
|
|
|
|
|
|
|
|
3
|
|
|
|
5
|
|
|
|
|
|
|
|
5
|
|
|
|
7
|
|
|
|
|
|
|
|
7
|
|
Sublease income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of patents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
Change in fair value of derivative instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party
|
|
|
(9,120
|
)
|
|
|
|
|
|
|
(9,120
|
)
|
|
|
(15,328
|
)
|
|
|
|
|
|
|
(15,328
|
)
|
|
|
(3,562
|
)
|
|
|
|
|
|
|
(3,562
|
)
|
Other
|
|
|
(4,847
|
)
|
|
|
|
|
|
|
(4,847
|
)
|
|
|
(7,271
|
)
|
|
|
|
|
|
|
(7,271
|
)
|
|
|
(4,440
|
)
|
|
|
|
|
|
|
(4,440
|
)
|
Interest expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Related party(1)
|
|
|
(65
|
)
|
|
|
1,206
|
|
|
|
(1,271
|
)
|
|
|
(859
|
)
|
|
|
2,210
|
|
|
|
(3,069
|
)
|
|
|
(1,997
|
)
|
|
|
2,645
|
|
|
|
(4,642
|
)
|
Other
|
|
|
(222
|
)
|
|
|
|
|
|
|
(222
|
)
|
|
|
(382
|
)
|
|
|
|
|
|
|
(382
|
)
|
|
|
(386
|
)
|
|
|
|
|
|
|
(386
|
)
|
Loss on extinguishment of debt(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,014
|
)
|
|
|
(17,014
|
)
|
|
|
|
|
|
|
(17,014
|
)
|
|
|
(17,014
|
)
|
|
|
|
|
Financing fees(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,858
|
)
|
|
|
(1,858
|
)
|
|
|
|
|
|
|
(1,858
|
)
|
|
|
(1,858
|
)
|
|
|
|
|
Total other non-operating income (expense)
|
|
|
(14,251
|
)
|
|
|
1,206
|
|
|
|
(15,457
|
)
|
|
|
(42,707
|
)
|
|
|
(16,662
|
)
|
|
|
(26,045
|
)
|
|
|
(28,750
|
)
|
|
|
(16,227
|
)
|
|
|
(12,523
|
)
|
Net loss
|
|
|
(17,259
|
)
|
|
|
1,206
|
|
|
|
(18,465
|
)
|
|
|
(48,832
|
)
|
|
|
(16,662
|
)
|
|
|
(32,170
|
)
|
|
|
(38,750
|
)
|
|
|
(16,227
|
)
|
|
|
(22,523
|
)
|
Net loss per share, basic and diluted
|
|
|
(0.41
|
)
|
|
|
0.03
|
|
|
|
(0.44
|
)
|
|
|
(1.14
|
)
|
|
|
(0.39
|
)
|
|
|
(0.75
|
)
|
|
|
(0.87
|
)
|
|
|
(0.36
|
)
|
|
|
(0.51
|
)
|
Weighted average shares outstanding, basic and diluted
|
|
|
42,077,334
|
|
|
|
|
|
|
|
42,077,334
|
|
|
|
42,711,367
|
|
|
|
|
|
|
|
42,711,367
|
|
|
|
44,291,889
|
|
|
|
|
|
|
|
44,291,889
|
|
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
|
(2) |
|
Adjustment for June 2010 to account for the modification of the
MHR Convertible Notes in connection with the Novartis Agreement
and the MHR Letter Agreement as an extinguishment of debt and
record the consideration for MHRs consent as a financing
fee |
99
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
2010
Statements of Cash Flows (unaudited
$thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
Six Months Ended June 30,
|
|
Nine Months Ended September 30,
|
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
Restated
|
|
|
|
Reported
|
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
2010
|
|
Adjustments
|
|
2010
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(17,259
|
)
|
|
|
1,206
|
|
|
|
(18,465
|
)
|
|
|
(48,832
|
)
|
|
|
(16,662
|
)
|
|
|
(32,170
|
)
|
|
|
(38,750
|
)
|
|
|
(16,227
|
)
|
|
|
(22,523
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
15
|
|
|
|
|
|
|
|
15
|
|
|
|
30
|
|
|
|
|
|
|
|
30
|
|
|
|
44
|
|
|
|
|
|
|
|
44
|
|
Amortization
|
|
|
60
|
|
|
|
|
|
|
|
60
|
|
|
|
120
|
|
|
|
|
|
|
|
120
|
|
|
|
179
|
|
|
|
|
|
|
|
179
|
|
Change in fair value of derivative instruments
|
|
|
13,968
|
|
|
|
|
|
|
|
13,968
|
|
|
|
22,599
|
|
|
|
|
|
|
|
22,599
|
|
|
|
8,003
|
|
|
|
|
|
|
|
8,003
|
|
Non-cash interest expense (1)(2)
|
|
|
287
|
|
|
|
(1,206
|
)
|
|
|
1,493
|
|
|
|
20,112
|
|
|
|
16,662
|
|
|
|
3,450
|
|
|
|
21,254
|
|
|
|
16,227
|
|
|
|
5,027
|
|
Non-cash compensation expense
|
|
|
407
|
|
|
|
|
|
|
|
407
|
|
|
|
547
|
|
|
|
|
|
|
|
547
|
|
|
|
685
|
|
|
|
|
|
|
|
685
|
|
Gain on disposal of fixed assets
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
Changes in assets and liabilities excluding non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in accounts receivable
|
|
|
154
|
|
|
|
|
|
|
|
154
|
|
|
|
120
|
|
|
|
|
|
|
|
120
|
|
|
|
99
|
|
|
|
|
|
|
|
99
|
|
Decrease (increase) in inventory
|
|
|
2
|
|
|
|
|
|
|
|
2
|
|
|
|
(24
|
)
|
|
|
|
|
|
|
(24
|
)
|
|
|
(24
|
)
|
|
|
|
|
|
|
(24
|
)
|
(Increase) in deposits on inventory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(420
|
)
|
|
|
|
|
|
|
(420
|
)
|
Decrease (increase) in prepaid expenses and other current assets
|
|
|
12
|
|
|
|
|
|
|
|
12
|
|
|
|
(531
|
)
|
|
|
|
|
|
|
(531
|
)
|
|
|
33
|
|
|
|
|
|
|
|
33
|
|
Increase in deferred revenue
|
|
|
2,007
|
|
|
|
|
|
|
|
2,007
|
|
|
|
2,012
|
|
|
|
|
|
|
|
2,012
|
|
|
|
2,069
|
|
|
|
|
|
|
|
2,069
|
|
Increase (decrease) in accounts payable and accrued expenses
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
|
|
887
|
|
|
|
|
|
|
|
887
|
|
|
|
(516
|
)
|
|
|
|
|
|
|
(516
|
)
|
Increase (decrease) in other current liabilities
|
|
|
(23
|
)
|
|
|
|
|
|
|
(23
|
)
|
|
|
(21
|
)
|
|
|
|
|
|
|
(21
|
)
|
|
|
415
|
|
|
|
|
|
|
|
415
|
|
Increase (decrease) in deferred lease liability
|
|
|
(30
|
)
|
|
|
|
|
|
|
(30
|
)
|
|
|
(17
|
)
|
|
|
|
|
|
|
(17
|
)
|
|
|
(25
|
)
|
|
|
|
|
|
|
(25
|
)
|
Decrease in restructuring accrual
|
|
|
(150
|
)
|
|
|
|
|
|
|
(150
|
)
|
|
|
(150
|
)
|
|
|
|
|
|
|
(150
|
)
|
|
|
(300
|
)
|
|
|
|
|
|
|
(300
|
)
|
Total adjustments
|
|
|
16,707
|
|
|
|
(1,206
|
)
|
|
|
17,913
|
|
|
|
45,683
|
|
|
|
16,662
|
|
|
|
29,021
|
|
|
|
31,495
|
|
|
|
16,227
|
|
|
|
15,268
|
|
Net cash used in operating activities
|
|
|
(552
|
)
|
|
|
|
|
|
|
(552
|
)
|
|
|
(3,149
|
)
|
|
|
|
|
|
|
(3,149
|
)
|
|
|
(7,255
|
)
|
|
|
|
|
|
|
(7,255
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of fixed assets
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
Capital expenditures and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from notes payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
500
|
|
Payments on notes payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(525
|
)
|
|
|
|
|
|
|
(525
|
)
|
Proceeds from the issuance of common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,674
|
|
|
|
|
|
|
|
6,674
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,649
|
|
|
|
|
|
|
|
6,649
|
|
Net decrease in cash and cash equivalents
|
|
|
(551
|
)
|
|
|
|
|
|
|
(551
|
)
|
|
|
(3,148
|
)
|
|
|
|
|
|
|
(3,148
|
)
|
|
|
(605
|
)
|
|
|
|
|
|
|
(605
|
)
|
Cash and cash equivalents, beginning of period
|
|
|
3,566
|
|
|
|
|
|
|
|
3,566
|
|
|
|
3,566
|
|
|
|
|
|
|
|
3,566
|
|
|
|
3,566
|
|
|
|
|
|
|
|
3,566
|
|
Cash and cash equivalents, end of period
|
|
|
3,015
|
|
|
|
|
|
|
|
3,015
|
|
|
|
418
|
|
|
|
|
|
|
|
418
|
|
|
|
2,961
|
|
|
|
|
|
|
|
2,961
|
|
Schedule of non cash financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued to settle accrued Directors compensation
|
|
|
11
|
|
|
|
|
|
|
|
11
|
|
|
|
11
|
|
|
|
|
|
|
|
11
|
|
|
|
11
|
|
|
|
|
|
|
|
11
|
|
Exchange of debt as deferred revenue (Note 8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,000
|
|
|
|
|
|
|
|
13,000
|
|
|
|
13,000
|
|
|
|
|
|
|
|
13,000
|
|
100
EMISPHERE
TECHNOLOGIES, INC.
NOTES TO
THE FINANCIAL STATEMENTS (Continued)
|
|
|
(1) |
|
Adjustment to amortize debt discounts and deferred financing
fees based a number nominally close to zero to enable interest
and debt discounts to be accreted over the life of the debt
using a level yield method |
|
(2) |
|
Adjustment for June 2010 to account for the modification of the
MHR Convertible Notes in connection with the Novartis Agreement
and the MHR Letter Agreement as an extinguishment of debt and
record the consideration for MHRs consent as a financing
fee |
On February 8, 2008, Emisphere reported that it had entered
into an agreement with MannKind Corporation to sell certain
Emisphere patents and a patent application relating to
diketopiperazine technology for a total purchase price of
$2.5 million. An initial payment of $1.5 million was
received in February 2008. An additional $0.5 million was
received in May 2009 and the remaining payment was received
September, 2010.
101
|
|
ITEM 9.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
|
None
|
|
ITEM 9A.
|
CONTROLS
AND PROCEDURES
|
Evaluation
of Disclosure Controls and Procedures (Restated)
The Companys senior management is responsible for
establishing and maintaining a system of disclosure controls and
procedures (as defined in
Rule 13a-15
and 15d-15
under the Securities Exchange Act of 1934 (the Exchange
Act)) designed to ensure that information required to be
disclosed by the Company in the reports that it files or submits
under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the Securities and
Exchange Commissions rules and forms. Disclosure controls
and procedures include, without limitation, controls and
procedures designed to ensure that information required to be
disclosed by an issuer in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the
issuers management, including its principal executive
officer or officers and principal financial officer or officers,
or persons performing similar functions, as appropriate to allow
timely decisions regarding required disclosure.
In its Annual Report filed on
Form 10-K
for the year ended December 31, 2009 and its Quarterly
Reports filed on
Form 10-Q
for the quarters ended March 31, June 30, and
September 30, 2009 and 2010, the Companys management,
with the participation of our Chief Executive Officer and Chief
Financial Officer, concluded that our disclosure controls and
procedures (as defined in
Rules 13a-15(e)
and
15d-15(e) to
the Securities Exchange Act of 1934, as amended (the Exchange
Act)) were effective as of the end of each of those
periods. In connection with our decision to restate our annual
financial results for the year ended December 31, 2009 as
originally filed on
Form 10-K
and to restate our quarterly results for the periods ended
March 31, June 30, and September 30, 2009 and
2010, as originally stated on
Form 10-Q,
as more fully described in Note 19 to the financial
statements of this
Form 10-K,
our management, including our Interim Chief Executive Officer
and Chief Financial Officer, performed a reevaluation and
concluded that our disclosure controls and procedures were not
effective as of the quarterly periods ended March 31,
June 30, and September 30, 2009 and 2010, nor for the
year ended December 31, 2009 and 2010 as a result of the
material weakness in our internal control over financial
reporting as discussed below.
In light of the material weakness described below, we performed
additional analysis and other post closing procedures to ensure
that our financial statements were prepared in accordance with
generally accepted accounting principles. Accordingly, we
believe that the financial statements included in this report
fairly present in all material respects, our financial
condition, results of operations and cash flows for the periods
presented.
Material
Weaknesses in Internal Control over Financial Reporting and
Status of Remediation Efforts
A material weakness is a deficiency, or combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material
misstatement of the companys annual or interim financial
statements will not be prevented or detected in a timely basis.
As a consequence of the restatement of financial information as
described in Note 19 to the financial statements contained
in this
Form 10-K,
the Company determined that as of the quarterly periods ended
March 31, June 30, and September 30, 2009 and
2010, and for the year ended December 31, 2009 and 2010, we
concluded that the Companys system of internal controls
did not effectively ensure completeness and accuracy with regard
to the proper recognition, presentation and disclosure of
accounting for certain non-cash interest expense and debt
discounts in connection the MHR Convertible Notes arising from
the adoption of Financial Accounting Standards Board Accounting
Codification Topic
815-40-15-5,
Evaluating Whether an Instrument Is Considered Indexed
to an Entitys Own Stock (FASB
ASC 815-40-15-5)
effective January 1, 2009.
102
Managements
Remediation Initiatives
In light of the material weakness described above, we designed
and implemented improvements in our internal control over
financial reporting to address the material weakness with regard
to the proper recognition, presentation and disclosure of
certain interest expense and debt discounts in connection with
debt instruments and warrants. These improvements included,
among other things; improved access to and evaluation of recent
accounting pronouncements as it relates to financing
arrangements and derivative instruments, including enhancing the
documentation around conclusions reached in the implementation
of applicable generally accepted accounting principles. In
addition, we will provide further training of those individuals
involved in technical accounting and reporting regarding
financing arrangements and derivative instruments.
Changes
in Internal Control over Financial Reporting
With the exception of changes described in Managements
Remediation Initiatives (above) which occurred subsequent to
December 31, 2010, there have been no changes in the
Companys system of internal controls over financial
reporting during the three month period ended December 31,
2010 that materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Our management does not expect that our disclosure controls and
procedures or internal controls over financial reporting will
prevent all errors and all fraud. A control system, no matter
how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the system are
met and cannot detect all deviations. Because of the inherent
limitations in all control systems, no evaluation of controls
can provide absolute assurance that all control issues and
instances of fraud or deviations, if any, within the company
have been detected. Projections of any evaluation of
effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures
may deteriorate.
Managements
Report on Internal Control over Financial
Reporting
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting, as such term
is defined in
Rules 13a-15(f)
and
15d-15(f)
under the Exchange Act. Our management conducted an evaluation
of the effectiveness of our internal control over financial
reporting based on the framework established in Internal
Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway
Commission. Based on that evaluation, our management has
concluded that our internal control over financial reporting was
not effective as of December 31, 2010. However, in light of
the material weakness described above, the Company subsequently
performed additional analysis and other post closing procedures
to ensure that our financial statements were prepared in
accordance with generally accepted accounting principles.
Accordingly, we believe that the financial statements included
in this report fairly present in all material respects, our
financial condition, results of operations and cash flows for
the periods presented.
McGladrey & Pullen LLP, our independent registered
public accounting firm, has issued a report on the effectiveness
of internal over financial reporting as of December 31,
2010, which report is included herein at pages 54 and 55.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
|
|
ITEM 9B.
|
OTHER
INFORMATION
|
None.
103
PART III
|
|
ITEM 10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
Director
and Executive Officer Information
Information regarding those directors serving unexpired terms
and our current Executive Officers, as such term is defined in
Regulation S-K
under the Exchange Act, all of whom are currently serving
open-ended terms, including their respective ages, the year in
which each first joined the Company and their principal
occupations or employment during the past five years, is
provided below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
|
|
|
|
|
|
|
Joined
|
|
|
Name
|
|
Age
|
|
Emisphere
|
|
Position with the Company
|
|
Michael R. Garone(1)(2)
|
|
|
52
|
|
|
|
2007
|
|
|
Vice President, Interim Chief Executive Officer, Chief Financial
Officer and Corporate Secretary
|
M. Gary I. Riley DVM, PhD
|
|
|
68
|
|
|
|
2007
|
|
|
Vice President of Non-Clinical Development and Applied Biology
|
Nicholas J. Hart
|
|
|
46
|
|
|
|
2008
|
|
|
Vice President Strategy and Development
|
John D. Harkey, Jr.
|
|
|
50
|
|
|
|
2006
|
|
|
Class I Director
|
Mark H. Rachesky, M.D.
|
|
|
52
|
|
|
|
2005
|
|
|
Class III Director
|
Timothy G. Rothwell
|
|
|
60
|
|
|
|
2009
|
|
|
Class I Director
|
Michael Weiser, M.D.
|
|
|
48
|
|
|
|
2005
|
|
|
Class III Director
|
|
|
|
(1) |
|
On February 28, 2011, Michael V. Novinski resigned as a
director of the Company and from his position as President and
Chief Executive Officer of the Company. |
|
(2) |
|
On February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company. |
Michael R. Garone joined Emisphere in 2007 as Vice
President and Chief Financial Officer. Mr. Garone has also
served as the Companys Corporate Secretary since October
2008. Mr. Garone previously served as Interim Chief
Executive Officer and Chief Financial Officer of Astralis, Ltd.
(OTCBB: ASTR.OB). Prior to that, Mr. Garone was with
AT&T (NYSE: T) for 20 years, where he held
several positions, including Chief Financial Officer of
AT&T Alascom. Mr. Garone received an MBA from Columbia
University and a BA in Mathematics from Colgate University. On
February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company.
John D. Harkey, Jr. has been a director of the
Company since April 2006. Mr. Harkey is Chairman and Chief
Executive Officer of Consolidated Restaurant Companies, Inc.
Mr. Harkey currently serves on the Board of Directors and
Audit Committees of Leap Wireless International, Inc. (NASDAQ:
LEAP), Loral Space & Communications, Inc. (NASDAQ:
LORL), Energy Transfer Equity, LP (NYSE: ETE), the Board of
Directors for the Baylor Health Care System Foundation and
serves as Chairman of the Board of Regency Energy Partners
(NASDAQ: RGNC). Mr. Harkey also serves on the
Presidents Development Council of Howard Payne University,
the Executive Board of Circle Ten Council of the Boy Scouts of
America and is a member of the Young Presidents
Organization. Mr. Harkey obtained a B.B.A. in honors and a
J.D. from the University of Texas at Austin and an M.B.A. from
Stanford University School of Business. Mr. Harkeys
entrepreneurial background, his qualification as a financial
expert, and his business and leadership experiences in a range
of different industries make him an asset to our Board of
Directors.
Mark H. Rachesky, M.D. has been a director of the
Company since 2005. Dr. Rachesky is the co-founder and
President of MHR Fund Management LLC and affiliates,
investment managers of various private investment funds that
invest in inefficient market sectors, including special
situation equities and distressed
104
investments. Dr. Rachesky is currently the Non-Executive
Chairman of the Board of Loral Space & Communications
Inc. (NASDAQ:LORL), Leap Wireless International, Inc. (NASDAQ:
LEAP) and Telesat Canada and is a member of the Board of
Directors of Lions Gate Entertainment Corp. (NYSE: LGF) and
Nationshealth, Inc. (formerly quoted on OTCBB:NHRX). He formerly
served on the Board of Directors of Neose Technologies, Inc
(NASDAQ: NTEC). Dr. Rachesky is a graduate of Stanford
University School of Medicine and Stanford University School of
Business. Dr. Rachesky graduated from the University of
Pennsylvania with a major in Molecular Aspects of Cancer.
Dr. Racheskys extensive investing and financial
background, his thorough knowledge of capital markets and his
training as an M.D., make him an asset to our Board of Directors.
Timothy G. Rothwell, has been a director since November
2009. Mr. Rothwell is the former Chairman of Sanofi-Aventis
U.S. From February 2007 to March 2009, Mr. Rothwell
served as Chairman of Sanofi-Aventis U.S. From September
2004 to February 2007, Mr. Rothwell was President and Chief
Executive Officer of the company, overseeing all domestic
commercial operations as well as coordination of Industrial
Affairs and Research and Development activities. From May 2003
to September 2004, Mr. Rothwell was President and Chief
Executive Officer of Sanofi-Synthelabo, Inc. and was
instrumental in the formation of Sanofi-Aventis U.S. in
2004. Prior to that, from June 1998 to May 2003, he served in
various capacities at Pharmacia, including as President of the
companys Global Prescription Business. From January 1995
to January 1998, Mr. Rothwell served as worldwide President
of Rhone-Poulenc Rorer Pharmaceuticals and President of the
companys Global Pharmaceutical Operations. In his long
career, Mr. Rothwell has also served as Chief Executive
Officer of Sandoz Pharmaceuticals, Vice President, Global
Marketing and Sales at Burroughs Wellcome, and Senior Vice
President of Marketing and Sales for the U.S. for Squibb
Corporation. Mr. Rothwell holds a Bachelor of Arts from
Drew University and earned his J.D. from Seton Hall University.
He formerly served on the PhRMA Board of Directors, as well as
the Institute of Medicines Evidence-Based Medicine
roundtable, the CEO Roundtable on Cancer, the Healthcare
Businesswomens Association Advisory Board, the Board of
Trustees for the Somerset Medical Center Foundation, the Board
of Trustees for the HealthCare Institute of New Jersey, and as a
Trustee of the Corporate Council for Americas Children at
the Childrens Health Fund. Presently, he is Chairman of
the Board of New American Therapeutics, and he serves on the
Board of Directors of Agenus (NASDAQ: AGEN), the Board of
Visitors for Seton Hall Law School, and the PheoPara Alliance, a
nonprofit 501(c)3 organization. Mr. Rothwells broad
business and leadership experiences in the pharmaceutical
industry and his affiliations with industry, educational and
healthcare related organizations make him an asset to our Board
of Directors.
Michael Weiser, M.D., Ph.D. has been a director
of the Company since 2005. Dr. Weiser is currently founder
and co-chairman of Actin Biomed, a New York based healthcare
investment firm advancing the discovery and development of novel
treatments for unmet medical needs. Prior to joining Actin
Biomed, Dr. Weiser was the Director of Research at
Paramount BioCapital where he was responsible for the
scientific, medical and financial evaluation of biomedical
technologies and pharmaceutical products under consideration for
development. Dr. Weiser completed his Ph.D. in Molecular
Neurobiology at Cornell University Medical College and received
his M.D. from New York University School of Medicine. He
performed his post-graduate medical training in the Department
of Obstetrics and Gynecology at New York University Medical
Center. Dr. Weiser also completed a Postdoctoral Fellowship
in the Department of Physiology and Neuroscience at New York
University School of Medicine and received his B.A. in
Psychology from University of Vermont. Dr. Weiser is a
member of The National Medical Honor Society, Alpha Omega Alpha,
American Society of Clinical Oncology, American Society of
Hematology and Association for Research in Vision and
Ophthalmology. In addition, Dr. Weiser has received awards
for both academic and professional excellence and is published
extensively in both medical and scientific journals.
Dr. Weiser currently serves on the board of directors of
Chelsea Therapeutics International, and Ziopharm Oncology, Inc.
as well as several privately held companies. Dr. Weiser has
an M.D. and a Ph.D., and his scientific, business and financial
experiences, as well as his knowledge of the healthcare
industry, capital markets, pharmaceutical products and
biomedical technology development make him an asset to our Board
of Directors.
Nicholas J. Hart, joined Emisphere in July 2008 as Vice
President, Strategy and Development. Immediately before joining
the Company, Mr. Hart was Leader of the Contraception
Therapy Area and a member of
105
the Corporate Executive Leadership Team at Organon, part of
Schering Plough Corporation. While at Organon, he served as
Senior Director/Executive Director of Marketing of the
Womens Healthcare Franchise; Director of CNS Marketing,
and Associate Director of Specialty Products. Prior to Organon,
Mr. Hart held various marketing and sales positions with
Novartis, Sankyo Parke Davis Pharmaceuticals, and Bristol-Myers
Squibb Company. After graduating from the United States Military
Academy at West Point, Mr. Hart received an MBA in Finance
and International Business from New York University, Stern
School of Business. He also served as a Field Artillery Officer
in the United States Army.
M. Gary I. Riley DVM, PhD joined Emisphere in
November 2007 as Vice-President of Nonclinical Development and
Applied Biology. He was previously Vice President of Toxicology
and Applied Biology at Alkermes, Inc., Cambridge, MA, where he
spent 14 years working in the field of specialized drug
delivery systems. He holds board certifications in veterinary
pathology and toxicology. He was previously employed as Director
of Pathobiology at Lederle Laboratories and earlier in his
career held positions as a veterinary pathologist in academia
and industry.
Section 16(a)
Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act, and the rules of the SEC
require our directors, Executive Officers and persons who own
more than 10% of common stock to file reports of their ownership
and changes in ownership of common stock with the SEC. Our
employees sometimes prepare these reports on the basis of
information obtained from each director and Executive Officer.
Based on written representations of the Companys directors
and Executive Officers and on confirmation that no Form 5
was required to be filed, we believe that all reports required
by Section 16(a) of the Exchange Act to be filed by its
directors, Executive Officers and greater than ten (10%) percent
owners during the last fiscal year were filed on time with the
exception of Form 4 filings made on behalf of Michael R.
Garone and M. Gary I. Riley on January 21, 2010.
Code of
Conduct for Officers and Employees and Code of Business Conduct
and Ethics for Directors
The Company has a Code of Conduct that applies to all of our
officers and employees as well as a Code of Business Conduct and
Ethics that applies specifically to the members of the Board of
Directors. The directors are surveyed annually regarding their
compliance with the policies as set forth in the Code of Conduct
for Directors. The Code of Conduct and the Code of Business
Conduct and Ethics for Directors are available on the Corporate
Governance section of our website at www.emisphere.com. The
contents of our website are not incorporated herein by reference
and the website address provided in this annual report is
intended to be an inactive textual reference only. The Company
intends to disclose on its website any amendment to, or waiver
of, a provision of the Code of Conduct that applies to the Chief
Executive Officer, Chief Financial Officer, or Controller. Our
Code of Conduct contains provisions that apply to our Chief
Executive Officer, Chief Financial Officer and all other finance
and accounting personnel. These provisions comply with the
requirements of a company code of ethics for financial officers
that were promulgated by the SEC pursuant to the Exchange Act.
Stockholder
Communications
We have an Investor Relations Office for all stockholder
inquiries and communications. The Investor Relations Office
facilitates the dissemination of accurate and timely information
to our stockholders. In addition, the Investor Relations Office
ensures that outgoing information is in compliance with
applicable securities laws and regulations. All investor queries
should be directed to our internal Director of Corporate
Communications or our Corporate Secretary.
Election
of Directors
The Governance and Nominating Committee identifies director
nominees by reviewing the desired experience, mix of skills and
other qualities to assure appropriate Board composition, taking
into consideration the current Board members and the specific
needs of the Company and the Board. Among the qualifications to
be considered in the selection of candidates, the Committee
considers the following attributes and criteria of
106
candidates: experience, knowledge, skills, expertise, diversity,
personal and professional integrity, character, business
judgment and independence. Although it has no formal policy our
Board recognizes that nominees for the Board should reflect a
reasonable diversity of backgrounds and perspectives, including
those backgrounds and perspectives with respect to business
experience, professional expertise, age, gender and ethnic
background.
Our Board is comprised of accomplished professionals who
represent diverse and key areas of expertise including national
and international business, operations, manufacturing, finance
and investing, management, entrepreneurship, higher education
and science, research and technology. We believe our
directors wide range of professional experiences and
backgrounds, education and skills has proven invaluable to the
Company and we intend to continue leveraging this strength.
Nominations for the election of directors may be made by the
Board of Directors or the Governance and Nominating Committee.
The committee did not reject any candidates recommended within
the preceding year by a beneficial owner of, or from a group of
security holders that beneficially owned, in the aggregate, more
than five percent (5%) of the Companys voting stock.
Although it has no formal policy regarding stockholder nominees,
the Governance and Nominating Committee believes that
stockholder nominees should be viewed in substantially the same
manner as other nominees. Stockholders may make a recommendation
for a nominee by complying with the notice procedures set forth
in our bylaws. The Governance and Nominating Committee will give
nominees recommended by stockholders in compliance with these
procedures the same consideration that it gives to any board
recommendations. To date, we have not received any
recommendation from stockholders requesting that the Governance
and Nominating Committee (or any predecessor) consider a
candidate for inclusion among the committees slate of
nominees in the Companys proxy statement.
To be considered by the committee, a director nominee must have
broad experience at the strategy/policy-making level in a
business, government, education, technology or public interest
environment, high-level managerial experience in a relatively
complex organization or experience dealing with complex
problems. In addition, the nominee must be able to exercise
sound business judgment and provide insights and practical
wisdom based on experience and expertise, possess proven ethical
character, be independent of any particular constituency, and be
able to represent all stockholders of the Company.
The committee will also evaluate whether the nominees
skills are complementary to the existing Board members
skills; the boards needs for operational, management,
financial, technological or other expertise; and whether the
individual has sufficient time to devote to the interests of
Emisphere. The prospective board member cannot be a board member
or officer at a competing company nor have relationships with a
competing company. He/she must be clear of any investigation or
violations that would be perceived as affecting the duties and
performance of a director.
The Governance and Nominating Committee identifies nominees by
first evaluating the current members of the Board of Directors
willing to continue in service. Current members of the board
with skills and experience that are relevant to the business and
who are willing to continue in service are considered for
re-nomination, balancing the value of continuity of service by
existing members of the board with that of obtaining a new
perspective. If any member of the board does not wish to
continue in service, or if the Governance and Nominating
Committee or the board decides not to nominate a member for
re-election, the Governance and Nominating Committee identifies
the desired skills and experience of a new nominee and discusses
with the board suggestions as to individuals that meet the
criteria.
The Audit
Committee
The Audit Committee operates under a written charter adopted by
the Board of Directors. The Audit Committee has reviewed the
relevant standards of the Sarbanes-Oxley Act of 2002, the rules
of the SEC, and the corporate governance listing standards of
the NASDAQ regarding committee policies. The committee intends
to further amend its charter, if necessary, as the applicable
rules and standards evolve to reflect any additional
requirements or changes. The updated Audit Committee charter can
be found on our website at
107
www.emisphere.com. The contents of our website are not
incorporated herein by reference and the website address
provided in this Proxy Statement is intended to be an inactive
textual reference only.
The Audit Committee is currently comprised of John D.
Harkey, Jr., (chairman), Timothy G. Rothwell, who was
appointed to the Committee on January 6, 2010, and Michael
Weiser, M.D. All of the members of the Audit Committee are
independent within the meaning of Rule 4200 of the NASDAQ.
The Board of Directors has determined that John D.
Harkey, Jr. is an Audit Committee financial
expert, within the meaning of Item 401(h) of
Regulation S-K.
|
|
ITEM 11.
|
EXECUTIVE
COMPENSATION
|
Summary
Compensation Table 2010, 2009 and 2008
The following table sets forth information regarding the
aggregate compensation Emisphere paid during 2010, 2009 and 2008
to our Principal Executive Officer, our Principal Financial
Officer, and the two other highest paid Executive Officers:
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Option
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Name and Principal
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Salary
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Bonus
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Stock
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Awards
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All Other
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Position(1)
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Year
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($)
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($)
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Awards ($)
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($)(2)
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Compensation($)
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Total ($)
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Michael V. Novinski(10),
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2010
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550,000
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312,175
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18,000
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(4)
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880,175
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President and CEO
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2009
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550,000
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239,759
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18,000
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(4)
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807,759
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2008
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554,231
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357,123
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(3)
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18,000
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(4)
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929,354
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Michael R. Garone,
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2010
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241,374
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19,445
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260,819
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Chief Financial Officer,
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2009
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234,313
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10,642
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244,955
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Corporate VP, and Corporate Secretary(5)(11)
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2008
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231,794
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231,794
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M. Gary I. Riley DVM, PhD,
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2010
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278,104
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19,445
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297,549
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VP of Non-Clinical
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2009
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269,969
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10,642
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8,000
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(7)
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279,011
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Development and
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2008
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267,039
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40,000
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(6)
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14,000
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(7)
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321,039
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Applied Biology(7)
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Nicholas J. Hart,
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2010
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249,657
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19,445
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269,102
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VP, Strategy and Development(8)
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2009
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242,880
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10,642
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253,522
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2008
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104,308
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16,872
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(9)
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173,550
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294,730
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|
(1) |
|
Only two individuals other than the Principal Executive Officer
and the Principal Financial Officer served as Executive Officers
at the end of fiscal year 2010. As a result, the named executive
officers, as defined in
Regulation S-K,
Item 402(a)(3), of the Company are as follows:
Mr. Novinski, Mr. Garone, Mr. Riley and
Mr. Hart. |
|
(2) |
|
Amounts shown in this column represent the aggregate grant date
fair value of stock option awards granted during the respective
year computed in accordance with Financial Accounting Standards
Board ASC Topic 718. This compares to prior years, during which
amounts in these columns have represented the expensed
accounting value of such awards. The amounts for 2008 and 2009
have been recomputed (along with amounts in the Total column for
such years) using the aggregate grant date fair value of stock
option awards granted during both of those years. For
assumptions used in the valuation of these awards please see
Note 12 to our Financial Statements for the fiscal year
ended December 31, 2010. |
|
(3) |
|
Mr. Novinski was paid a bonus in 2008 for performance in
2007 in accordance with the terms of his employment contract. |
|
(4) |
|
All other compensation for Mr. Novinski represents an
allowance for the use of a personal automobile in accordance
with the terms of his employment contract. |
|
(5) |
|
Mr. Garone was appointed Corporate Secretary effective
October 24, 2008. |
|
(6) |
|
In accordance with the terms of his employment contract,
Dr. Riley received a signing bonus, payable during 2008,
when he joined the Company. |
|
(7) |
|
All other compensation for Mr. Riley represents payments
for relocation expenses. |
108
|
|
|
(8) |
|
Mr. Hart accepted the position as Vice President, Strategy
and Development effective July 28, 2008. |
|
(9) |
|
Mr. Hart received a signing bonus when he joined the
Company. |
|
(10) |
|
On February 28, 2011, Michael V. Novinski resigned as a
director of the Company and from his position as President and
Chief Executive Officer of the Company. |
|
(11) |
|
On February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company. |
Compensation
Discussion And Analysis
Executive
Summary
The discussion that follows outlines the compensation awarded
to, earned by or paid to the named executive officers of the
Company including a review of the principal elements of
compensation, the objectives of the Companys compensation
program, what the program is designed to reward and why and how
each element of compensation is determined.
In general, the Company operates in a marketplace where
competition for talented executives is significant. The Company
is engaged in the long-term development of its technology and of
drug candidates, without the benefit of significant current
revenues, and therefore its operations require it to raise
capital in order to continue its activities. Our operations
entail special needs and risks and require that the Company
attempt to implement programs that promote strong individual and
group performance and retention of excellent employees. The
Companys compensation program for named executive officers
consists of cash compensation as base salary, medical, basic
life insurance, long term disability, flexible spending
accounts, paid time off, and defined contribution retirement
plans as well as long term equity incentives offered through
stock option plans. This program is developed in part by
benchmarking against other companies in the
biotechnology/pharmaceutical sectors, as well as by the judgment
and discretion of our Board of Directors.
Employee salaries are benchmarked against Radford survey
information. Radford is part of the Aon family brands. For more
than 30 years, Radford has been a leading provider of
compensation market intelligence to the high-tech and life
sciences industries. Radford emphasizes data integrity and
online access to data, tools and resources, as well as client
service geared towards life sciences. Radford includes more than
2,000 participating companies globally. Their services offer
full compensation consulting, reliable, current data analysis
and reporting, customized data for competitive insight, and web
access to data via the Radford Network.
Discussion
and Analysis
Objectives of the compensation and reward
program The biopharmaceutical marketplace is
highly competitive and includes companies with far greater
resources than ours. Our work involves the difficult,
unpredictable, and often slow development of our technology and
of drug candidates. Continuity of scientific knowledge,
management skills, and relationships are often critical success
factors to our business. The objectives of our compensation
program for named executive officers is to provide competitive
cash compensation, competitive health, welfare and defined
contribution retirement benefits as well as long-term equity
incentives that offer significant reward potential for the risks
assumed and for each individuals contribution to the
long-term performance of the Company. Individual performance is
measured against long-term strategic goals, short-term business
goals, scientific innovation, regulatory compliance, new
business development, development of employees, fostering of
teamwork and other Emisphere values designed to build a culture
of high performance. These policies and practices are based on
the principle that total compensation should serve to attract
and retain those executives critical to the overall success of
Emisphere and are designed to reward executives for their
contributions toward business performance that is designed to
build and enhance stockholder value.
Elements of compensation and how they are
determined The key elements of the executive
compensation package are base salary (as determined by the
competitive market and individual performance), the executive
long term disability plan and other health and welfare benefits
and long-term incentive compensation
109
in the form of periodic stock option grants. The base salary
(excluding payment for accrued but unused vacation) for the
named Executive Officers for 2010 ranged from $241,374 for its
Vice President and Chief Financial Officer to $550,000 for its
President and Chief Executive Officer. In determining the
compensation for each named Executive Officer, the Company
generally considers (i) data from outside studies and proxy
materials regarding compensation of executive officers at
companies believed to be comparable, (ii) the input of
other directors and the President and Chief Executive Officer
(other than for his own compensation) regarding individual
performance of each named executive officer and
(iii) qualitative measures of Emispheres performance,
such as progress in the development of the Companys
technology, the engagement of corporate partners for the
commercial development and marketing of products, effective
corporate governance, fiscal responsibility, the success of
Emisphere in raising funds necessary to conduct research and
development, and the pace at which the Company continues to
advance its technologies in various clinical trials. Our board
of directors and Compensation Committees consideration of
these factors is subjective and informal. However, in general,
it has determined that the compensation for executive officers
should be competitive with market data reflected within the
50th-75th percentile
of biotechnology companies for corresponding senior executive
positions. Compensation levels for 2009 were derived from the
compensation plan set in 2006 and were based in part by
information received from executive compensation consultants,
Pearl Myer and Partners, based in New York, N.Y. Compensable
factors benchmarked include market capitalization, head count
and location. While the Company has occasionally paid cash
bonuses in the past, there is no consistent annual cash bonus
plan for named executive officers. When considering the
compensation of the Companys President and Chief Executive
Officer, the Company receives information and analysis prepared
or secured by the Companys outside executive compensation
experts and survey data prepared by human resources management
personnel as well as any additional outside information it may
have available.
The compensation program also includes periodic awards of stock
options. The stock option element is considered a long-term
incentive that further aligns the interests of executives with
those of our stockholders and rewards long-term performance and
the element of risk. Stock option awards are made at the
discretion of the Board of Directors based on its subjective
assessment of the individual contribution of the executive to
the attainment of short and long-term Company goals, such as
collaborations with partners, attainment of successful
milestones under such collaborations and other corporate
developments which advance the progress of our technology and
drug candidates. Option grants, including unvested grants, for
our named executive officers range from 115,000 for our Vice
President, Chief Financial Officer and Corporate Secretary; Vice
President of Non-Clinical Development and Applied Biology; and
Vice President, Strategy and Development, to 1,600,000 for
President and Chief Executive Officer as indicated in the
accompanying tables. Stock option grants to named executive
officers in 2010 were made in connection with the annual
compensation review. With the exception of grants made to the
Companys President and Chief Executive Officer (described
in Part III, Item 13 Certain Relationships,
Related Transactions and Director Independence), the
Companys policy with respect to stock options granted to
executives is that grant prices should be equal to the fair
market value of the common stock on the date of grant, that
employee stock options should generally vest over a three to
five-year period and expire in ten years from date of grant, and
that options previously granted at exercise prices higher than
the current fair market value should not be re-priced. Once
performance bonuses or awards are issued, there are currently no
policies in place to reduce, restate or otherwise adjust awards
if the relevant performance measures on which they are based are
restated or adjusted. The Company has no policy to require its
named executive officers to hold any specific equity interest in
the Company. The Company does not offer its named executive
officers any nonqualified deferred compensation, a defined
benefit pension program or any post retirement medical or other
benefits.
Section 162(m) of the Internal Revenue Code of 1986, as
amended, provides that compensation in excess of $1,000,000 paid
to the Chief Executive Officer or to any of the other four most
highly compensated executive officers of a publicly held company
will not be deductible for federal income tax purposes, unless
such compensation is paid pursuant to one of the enumerated
exceptions set forth in Section 162(m). The Companys
primary objective in designing and administering its
compensation policies is to support and encourage the
achievement of the Companys long-term strategic goals and
to enhance stockholder value. In general, stock options granted
under the Companys 2000 Plan and 2007 Plan are intended to
qualify under and comply with the performance based
compensation exemption provided under Section 162(m)
thus
110
excluding from the Section 162(m) compensation limitation
any income recognized by executives at the time of exercise of
such stock options. Because salary and bonuses paid to our Chief
Executive Officer and four most highly compensated executive
officers have been below the $1,000,000 threshold, the
Compensation Committee has elected, at this time, to retain
discretion over bonus payments, rather than to ensure that
payments of salary and bonus in excess of $1,000,000 are
deductible. The Compensation Committee intends to review
periodically the potential impacts of Section 162(m) in
structuring and administering the Companys compensation
programs.
Grants of
Plan-Based Awards 2010
The following table sets forth information regarding grants of
plan-based awards in 2010:
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All Other
|
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|
|
Option
|
|
|
|
|
|
|
|
|
Awards:
|
|
Exercise or
|
|
|
|
|
|
|
Number of
|
|
Base Price of
|
|
|
|
|
|
|
Securities
|
|
Option
|
|
Grant Date
|
|
|
|
|
Underlying
|
|
Awards
|
|
Fair Value of
|
Name
|
|
Grant Date
|
|
Options (#)
|
|
($/Sh)
|
|
Option Awards
|
|
Michael V. Novinski(1),
|
|
|
3/10/2010
|
|
|
|
300,000
|
|
|
$
|
1.34
|
|
|
$
|
312,175
|
|
President and CEO
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael R. Garone, VP,
|
|
|
1/19/2010
|
|
|
|
20,000
|
|
|
|
1.25
|
|
|
|
19,445
|
|
Chief Financial Officer,
Corporate VP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and Corporate Secretary(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M. Gary I. Riley DVM,
|
|
|
1/19/2010
|
|
|
|
20,000
|
|
|
|
1.25
|
|
|
|
19,445
|
|
PhD. VP, Non-Clinical
Development and Applied Biology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nicholas J. Hart,
|
|
|
1/19/2010
|
|
|
|
20,000
|
|
|
|
1.25
|
|
|
|
19,445
|
|
Vice President, Strategy and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
On February 28, 2011, Michael V. Novinski resigned as a
director of the Company and from his position as President and
Chief Executive Officer of the Company |
|
(2) |
|
On February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company. |
111
Outstanding
Equity Awards at Fiscal Year-End 2010
The following table sets forth information as to the number and
value of unexercised options held by the Executive Officers
named above as of December 31, 2010. There are no
outstanding stock awards with executive officers:
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|
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Equity
|
|
|
|
|
|
|
|
|
|
|
Incentive
|
|
|
|
|
|
|
|
|
Number of
|
|
Plan Awards:
|
|
|
|
|
|
|
Number of
|
|
Securities
|
|
Number of
|
|
|
|
|
|
|
Shares
|
|
Underlying
|
|
Securities
|
|
|
|
|
|
|
Underlying
|
|
Unexercised
|
|
Underlying
|
|
|
|
|
|
|
Unexercised
|
|
Unearned
|
|
Unexercised
|
|
Option
|
|
Option
|
|
|
Options (#)
|
|
Options (#)
|
|
Unearned
|
|
Exercise
|
|
Expiration
|
Name
|
|
Exercisable
|
|
Unexercisable
|
|
Options (#)
|
|
Price ($)
|
|
Date
|
|
Michael V. Novinski(6),
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
$
|
3.19
|
|
|
|
4/6/2017
|
|
President and CEO
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
$
|
6.38
|
|
|
|
4/6/2017
|
|
|
|
|
300,000
|
|
|
|
|
|
|
|
|
|
|
$
|
0.93
|
|
|
|
5/15/2019
|
|
|
|
|
200,000
|
|
|
|
100,000
|
(1)
|
|
|
|
|
|
$
|
1.34
|
|
|
|
3/10/2020
|
|
Michael R. Garone, VP,
|
|
|
45,000
|
|
|
|
30,000
|
(2)
|
|
|
|
|
|
$
|
4.03
|
|
|
|
8/29/2017
|
|
Chief Financial Officer,
|
|
|
5,000
|
|
|
|
15,000
|
(3)
|
|
|
|
|
|
$
|
0.62
|
|
|
|
4/12/2019
|
|
Corporate VP
|
|
|
|
|
|
|
20,000
|
(4)
|
|
|
|
|
|
$
|
1.25
|
|
|
|
1/19/2020
|
|
and Corporate Secretary(7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
M. Gary I. Riley DVM,
|
|
|
75,000
|
|
|
|
|
|
|
|
|
|
|
$
|
4.02
|
|
|
|
11/6/2017
|
|
PhD. VP, Non-Clinical
|
|
|
5,000
|
|
|
|
15,000
|
(3)
|
|
|
|
|
|
$
|
0.62
|
|
|
|
4/12/2019
|
|
Development and Applied Biology
|
|
|
|
|
|
|
20,000
|
(4)
|
|
|
|
|
|
$
|
1.25
|
|
|
|
1/19/2020
|
|
Nicholas J. Hart,
|
|
|
30,000
|
|
|
|
45,000
|
(5)
|
|
|
|
|
|
$
|
2.71
|
|
|
|
7/14/2018
|
|
Vice President, Strategy
|
|
|
5,000
|
|
|
|
15,000
|
(3)
|
|
|
|
|
|
$
|
0.62
|
|
|
|
4/12/2019
|
|
and Development
|
|
|
|
|
|
|
20,000
|
(4)
|
|
|
|
|
|
$
|
1.25
|
|
|
|
1/19/2020
|
|
|
|
|
(1) |
|
100,000 exercisable as of 12/31/2011 |
|
(2) |
|
15,000 exercisable as of 8/29/2011 and 8/29/2012, respectively |
|
(3) |
|
5,000 exercisable as of 4/12/2011; 10,000 exercisable as of
4/12/2012 |
|
(4) |
|
5,000 exercisable as of 1/19/2011 and 1/19/2012, respectively
and 10,000 exercisable as of 1/19/2013 |
|
(5) |
|
15,000 exercisable as of 7/14/2011, 7/14/2012 and 7/14/2013,
respectively |
|
(6) |
|
On February 28, 2011, Michael V. Novinski resigned as a
director of the Company and from his position as President and
Chief Executive Officer of the Company |
|
(7) |
|
On February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company. |
Option
Exercises and Stock Vested 2010
There were no stock options exercised by Executive Officers
during 2010.
Compensation
Committee Interlocks and Insider Participation
The current members of the Compensation Committee are
Dr. Weiser and Dr. Rachesky. No member of the
Compensation Committee is or has ever been an executive officer
or employee of our company (or any of its subsidiaries) and no
compensation committee interlocks existed during
fiscal year 2010. For further information about our processes
and procedures for the consideration and determination of
executive and director compensation, please see
Executive Compensation Compensation
Discussion and Analysis.
Compensation
Committee Report
The Compensation Committee operates under a written charter
adopted by the Board of Directors. The Compensation Committee
charter can be found on our website at www.emisphere.com. The
contents of our
112
website are not incorporated herein by reference and the website
address provided in this annual report is intended to be an
inactive textual reference only.
The Compensation Committee is responsible for the consideration
of stock plans, performance goals and incentive awards, and the
overall coverage and composition of the compensation
arrangements related to executive officers. The Compensation
Committee may delegate any of the foregoing duties and
responsibilities to a subcommittee of the Compensation Committee
consisting of not less than two members of the committee. The
Compensation Committee has the authority to retain, at the
expense of the Company, such outside counsel, experts and other
advisors as deemed appropriate to assist it in the full
performance of its functions. The Companys Chief Executive
Officer is involved in making recommendations to the
Compensation Committee for compensation of Executive Officers
(except for himself) as well as recommending compensation levels
for directors.
Our executive compensation program is administered by the
Compensation Committee of the Board of Directors. The
Compensation Committee, which is composed of non-employee
independent directors, is responsible for reviewing with Company
management and approving compensation policy and all forms of
compensation for executive officers and directors in light of
the Companys current business environment and the
Companys strategic objectives. In addition, the
Compensation Committee acts as the administrator of the
Companys stock option plans. The Compensation
Committees practices include reviewing and establishing
executive officers compensation to ensure that base pay
and incentive compensation are competitive to attract and retain
qualified executive officers, and to provide incentive systems
reflecting both financial and operating performance, as well as
an alignment with stockholder interests. These policies are
based on the principle that total compensation should serve to
attract and retain those executives critical to the overall
success of Emisphere and should reward executives for their
contributions to the enhancement of stockholder value.
The Compensation Committee oversees risk management as it
relates to our compensation plans, policies and practices in
connection with structuring our executive compensation programs
and reviewing our incentive compensation programs for other
employees. The committee considered risk when developing our
compensation programs and believes that the design of our
current compensation programs do not encourage excessive or
inappropriate risk taking. Our base salaries provide competitive
fixed compensation, while annual cash bonuses and equity-based
awards encourage long-term consideration rather than short-term
risk taking.
The Compensation Committee has reviewed the Compensation
Discussion and Analysis presented herein under
Compensation Plans with the management of the
Company. Based on that review and discussion, the Compensation
Committee recommended to the Board of Directors that the
Compensation Discussion and Analysis be included in the
Form 10-K
and Proxy Statement of the Company.
The
Members of the Compensation Committee
Michael
Weiser, M.D., Ph.D. (Chairman)
Mark H.
Rachesky, M.D.
Audit
Committee Report
The Audit Committee operates under a written charter adopted by
the Board of Directors. The Audit Committee has reviewed the
relevant standards of the Sarbanes-Oxley Act of 2002, the rules
of the SEC, and the corporate governance listing standards of
the NASDAQ regarding committee policies. The committee intends
to further amend its charter, if necessary, as the applicable
rules and standards evolve to reflect any additional
requirements or changes. The updated Audit Committee charter can
be found on our website at www.emisphere.com. The
contents of our website are not incorporated herein by reference
and the website address provided in this Proxy Statement is
intended to be an inactive textual reference only.
The Audit Committee is currently comprised of John D.
Harkey, Jr., (chairman), Timothy G. Rothwell, who was
appointed to the Committee on January 6, 2010, and Michael
Weiser, M.D. All of the members of the Audit Committee are
independent within the meaning of Rule 4200 of the NASDAQ.
The Board of
113
Directors has determined that John D. Harkey, Jr. is an
Audit Committee financial expert, within the meaning
of Item 401(h) of
Regulation S-K.
On January 6, 2010, with the approval of the Audit
Committee of the Company, the Company engaged M&P to act as
its independent registered public accounting firm. During the
years ended December 2007, and 2008, respectively, in the
subsequent interim periods through January 5, 2010, neither
the Company nor anyone acting on its behalf had consulted with
M&P on any of the matters or events set forth in
Item 304(a)(2) of
Regulation S-K.
Management has primary responsibility for the Companys
financial statements and the overall reporting process,
including the Companys system of internal control over
financial reporting. M&P, the Companys independent
registered public accountants, audit the annual financial
statements prepared by management, express an opinion as to
whether those financial statements fairly present the
consolidated financial position, results of operations and cash
flows of the Company and its subsidiaries in conformity with
accounting principles generally accepted in the United States,
and report on internal control over financial reporting.
M&P reports to the Audit Committee as members of the Board
of Directors and as representatives of the Companys
stockholders.
The Audit Committee meets with management periodically to
consider the adequacy of the Companys internal control
over financial reporting and the objectivity of its financial
reporting. The Audit Committee discusses these matters with the
appropriate Company financial personnel. In addition, the Audit
Committee has discussions with management concerning the process
used to support certifications by the Companys Chief
Executive Officer and Chief Financial Officer that are required
by the SEC and the Sarbanes-Oxley Act to accompany the
Companys periodic filings with the SEC.
On an as needed basis, the Audit Committee meets privately with
M&P. The Audit Committee also appoints the independent
registered public accounting firm, approves in advance their
engagements to perform audit and any non-audit services and the
fee for such services, and periodically reviews their
performance and independence from management. In addition, when
appropriate, the Audit Committee discusses with M&P plans
for the audit partner rotation required by the Sarbanes-Oxley
Act.
Pursuant to its charter, the Audit Committee assists the board
in, among other things, monitoring and reviewing (i) our
financial statements, (ii) our compliance with legal and
regulatory requirements and (iii) the independence,
performance and oversight of our independent registered public
accounting firm. Under the Audit Committee charter, the Audit
Committee is required to make regular reports to the board.
During the 2010 Fiscal Year, the Audit Committee of the Board of
Directors reviewed and assessed:
|
|
|
|
|
the quality and integrity of the annual audited financial
statements with management, including issues relating to
accounting and auditing principles and practices, as well as the
adequacy of internal controls, and compliance with regulatory
and legal requirements;
|
|
|
|
the qualifications and independence of the independent
registered public accounting firm; and
|
|
|
|
managements, as well as the independent auditors,
analysis regarding financial reporting issues and judgments made
in connection with the preparation of our financial statements,
including those prepared quarterly and annually, prior to filing
our quarterly reports on
Form 10-Q
and annual report on
Form 10-K.
|
The Audit Committee has reviewed the audited financial
statements and has discussed them with both management and
M&P, the independent registered public accounting firm. The
Audit Committee has discussed with the independent auditors
matters required to be discussed by the applicable Auditing
Standards as periodically amended (including significant
accounting policies, alternative accounting treatments and
estimates, judgments and uncertainties). In addition, the
independent auditors provided to the Audit Committee the written
disclosures required by the applicable requirements of the
Public Company Accounting Oversight Board regarding the
independent auditors communications with the Audit
Committee concerning independence, and the Audit Committee and
the independent auditors have discussed the auditors
independence from the Company and its management, including the
matters in those written disclosures. The Audit Committee
114
also received reports from M&P regarding all critical
accounting policies and practices used by the Company, any
alternative treatments of financial information used, generally
accepted accounting principles that have been discussed with
management, ramifications of the use of alternative treatments
and the treatment preferred by M&P and other material
written communications between M&P and management,
including management letters and schedules of adjusted
differences.
In making its decision to select M&P as Emispheres
independent registered public accounting firm for 2010, the
Audit Committee considers whether the non-audit services
provided by M&P are compatible with maintaining the
independence of M&P.
Based upon the review and discussions referenced above, the
Audit Committee, as comprised at the time of the review and with
the assistance of the Companys Chief Financial Officer,
recommended to the Board of Directors that the audited financial
statements be included in our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2010 and be filed
with the SEC.
The
Members of the Audit Committee
John
D. Harkey, Jr. (Chairman)
Timothy G. Rothwell
Michael Weiser, M.D.
Compensation
of Non-Employee Directors
A director who is a full-time employee of the Company receives
no additional compensation for services provided as a director.
It is the Companys policy to provide competitive
compensation and benefits necessary to attract and retain high
quality non-employee directors and to encourage ownership of
Company stock to further align their interests with those of
stockholders. The following represents the compensation of the
non-employee members of the Board of Directors:
|
|
|
|
|
Prior to June 24, 2009, each non-employee director
received, on the date of each regular annual stockholders
meeting, a stock option to purchase 7,000 shares of our
common stock under the 2007 Plan. The stock options vest on the
six month anniversary of the grant date provided the director
continuously serves as a director from the grant date through
such vesting date. Notwithstanding the foregoing, any director
who holds any stock options granted before April 1, 2004
which remain unvested was ineligible to receive the annual
7,000-share stock option grant described in this paragraph
unless and until all such prior options had vested. Stock
options granted in 2009 have a stated expiration date of ten
years after the date of grant, and are subject to accelerated
vesting upon a change in control of Emisphere. If the holder of
an option ceases to serve as a director, all previously granted
options may be exercised to the extent vested within six months
after termination of directorship (one year if the termination
is by reason of death), except that, after April 1, 2004
(unless otherwise provided in an option agreement), if a
director becomes an emeritus director of Emisphere
immediately following his Board service, the vested options may
be exercised for six months after termination of service as an
emeritus director. All unvested options expire upon
termination of service on the Board of Directors.
|
|
|
|
On May 15, 2009, in recognition of the roles and
responsibilities of the Board of Directors and current market
data, the non-employees members of the Board of Directors
compensation was revised to include a special one-time grant of
50,000 options to purchase shares of common stock granted on
May 15, 2009, an annual retainer of $35,000, payable
quarterly in cash, and an annual stock option grant of 40,000
options to purchase shares of common stock. The annual stock
option grants are granted each year on the date of the annual
meeting of stockholders of the Company. The director must be an
eligible director on the dates the retainers are paid and the
stock options are granted. The options subject to the special
one-time stock option grant and annual stock option grant would
vest over three years in equal amounts on each anniversary of
the grant date provided the director continuously serves as a
director from the grant date through such vesting date, subject
to accelerated vesting upon a
|
115
|
|
|
|
|
change in control of Emisphere. Such options, once vested,
remain exercisable through the period of the option term.
|
|
|
|
|
|
All newly appointed directors shall receive an initial stock
option grant on the date of appointment of 50,000 options to
purchase shares of common stock. The options subject to such
initial stock option grant vest over three years in equal
amounts on each anniversary of the grant date provided the
director continuously serves as a director from the grant date
through such vesting date, subject to accelerated vesting upon a
change in control of Emisphere. Such options, once vested,
remain exercisable through the period of the option term.
|
|
|
|
On May 15, 2009, Messrs. Weiser, Harkey and Rachesky
received a one-time special stock option grant of
25,000 shares of common stock and a one-time fee of $10,000
in recognition for their length of service on the Board of
Directors. The options subject to these one-time stock option
grants vest over three years in equal amounts on each
anniversary of the grant date provided the director continuously
serves as a director from the grant date through such vesting
date, subject to accelerated vesting upon a change in control of
Emisphere. Such options, once vested, remain exercisable through
the period of the option term.
|
|
|
|
Additional committee and chairperson fees are paid as follows:
|
|
|
|
|
|
$10,000 audit committee chairperson fee;
|
|
|
|
$2,500 audit committee member fee;
|
|
|
|
$5,000 compensation committee chairperson fee;
|
|
|
|
$1,000 compensation committee member fee;
|
|
|
|
$2,500 governance and nominating committee chairperson
fee; and
|
|
|
|
$500 governance and nominating committee member fee.
|
The director must be an eligible director on the dates such fees
are paid.
Director
Compensation Table 2010
The table below represents the compensation paid to our
non-employee directors during the year ended December 31,
2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned
|
|
Stock
|
|
Option
|
|
All Other
|
|
|
|
|
or Paid
|
|
Awards
|
|
Awards
|
|
Compensation
|
|
Total
|
Name
|
|
in Cash ($)
|
|
($)(1)
|
|
($)(1)
|
|
($)
|
|
($)
|
|
John D. Harkey, Jr.
|
|
|
45,000
|
|
|
|
|
|
|
|
36,940
|
|
|
|
|
|
|
|
81,940
|
|
Mark H. Rachesky, M.D.
|
|
|
36,500
|
|
|
|
|
|
|
|
36,940
|
|
|
|
|
|
|
|
73,440
|
|
Timothy G. Rothwell
|
|
|
33,958
|
|
|
|
|
|
|
|
36,940
|
|
|
|
|
|
|
|
70,898
|
|
Michael Weiser, M.D.
|
|
|
45,000
|
|
|
|
|
|
|
|
36,940
|
|
|
|
|
|
|
|
81,940
|
|
|
|
|
(1) |
|
The value listed in the above table represents the fair value of
the options recognized as expense under FASB ASC Topic 718
during 2010, including unvested options granted before 2010 and
those granted in 2010. Fair value is calculated as of the grant
date using the Black-Scholes-Model. The determination of the
fair value of share-based payment awards made on the date of
grant is affected by our stock price as well as assumptions
regarding a number of complex and subjective variables. Our
assumptions in determining fair value are described in
note 12 to our audited financial statements for the year
ended December 31, 2010. |
116
The following table summarizes the aggregate number of option
awards and stock awards held by each non-employee director at
December 31, 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Awards
|
|
Stock Awards
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incentive Plan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Awards:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Number of
|
|
|
|
|
|
Number of
|
|
Market
|
|
|
Number of
|
|
Securities
|
|
Securities
|
|
|
|
|
|
Shares of
|
|
Value of
|
|
|
Securities
|
|
Underlying
|
|
Underlying
|
|
|
|
|
|
Units of
|
|
Shares or
|
|
|
Underlying
|
|
Unexercised
|
|
Unexercised
|
|
|
|
|
|
Stock That
|
|
Units of
|
|
|
Unexercised
|
|
Unearned
|
|
Unearned
|
|
Option
|
|
Option
|
|
Have not
|
|
Stock That
|
|
|
Options (#)
|
|
Options (#)
|
|
Options
|
|
Exercise
|
|
Expiration
|
|
Vested
|
|
Have not
|
Name
|
|
Exercisable
|
|
Unexercisable
|
|
(#)
|
|
Price ($)
|
|
Date
|
|
(#)
|
|
Vested ($)
|
|
John D. Harkey, Jr.
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
8.97
|
|
|
|
5/26/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.76
|
|
|
|
4/20/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.79
|
|
|
|
8/8/2018
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
|
50,000
|
(1)
|
|
|
|
|
|
|
0.93
|
|
|
|
5/15/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(2)
|
|
|
|
|
|
|
1.20
|
|
|
|
9/16/2020
|
|
|
|
|
|
|
|
|
|
Mark H. Rachesky, M.D.
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.76
|
|
|
|
4/20/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.79
|
|
|
|
8/8/2018
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
|
50,000
|
(1)
|
|
|
|
|
|
|
0.93
|
|
|
|
5/15/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(2)
|
|
|
|
|
|
|
1.20
|
|
|
|
9/16/2020
|
|
|
|
|
|
|
|
|
|
Michael Weiser, M.D.
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
8.97
|
|
|
|
5/26/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.76
|
|
|
|
4/20/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
7,000
|
|
|
|
|
|
|
|
|
|
|
|
3.79
|
|
|
|
8/8/2018
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
|
50,000
|
(1)
|
|
|
|
|
|
|
0.93
|
|
|
|
5/15/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(2)
|
|
|
|
|
|
|
1.20
|
|
|
|
9/16/2020
|
|
|
|
|
|
|
|
|
|
Timothy G. Rothwell
|
|
|
16,666
|
|
|
|
33,334
|
(3)
|
|
|
|
|
|
|
0.70
|
|
|
|
11/5/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(2)
|
|
|
|
|
|
|
1.20
|
|
|
|
9/16/2020
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
25,000 exercisable as of 5/15/2011 and 5/15/2012, respectively. |
|
(2) |
|
13,333 exercisable as of 9/16/2011 and 9/16/2012, respectively
and 13,334 exercisable as of 9/16/2013. |
|
(3) |
|
16,667 exercisable as of 11/5/2011 and 11/5/2012, respectively. |
117
|
|
ITEM 12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
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Securities
Available For Future Issuance Under Equity Plans
The following table provides information as of December 31,
2010 about the common stock that may be issued upon the exercise
of options granted to employees, consultants or members of our
Board of Directors under our existing equity compensation plans,
including the 1991 Stock Option Plan, 1995 Stock Option Plan,
2000 Stock Option Plan, the 2002 Broad Based Plan, the 2007
Stock Award and Incentive Plan (collectively the
Plans) the Stock Incentive Plan for Outside
Directors and the Directors Deferred Compensation Plan:
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(a)
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(c)
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Number of
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Number of Securities
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Securities to be
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(b)
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Remaining Available for
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Issued Upon
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Weighted Average
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Future Issuance Under
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Exercise of
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Exercise Price
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Equity Compensation Plans
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Outstanding
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of Outstanding
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(Excluding Securities
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Plan Category
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Options
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Options
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Reflected in Column (a))
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Equity Compensation Plans Approved by Security Holders
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The Plans
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3,055,866
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$
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3.29
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1,432,148
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Stock Incentive Plan for Outside Directors
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100,000
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10.24
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Directors Deferred Compensation Plan
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Equity Compensation Plans not approved by Security
Holders(1)
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10,000
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3.64
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Total
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3,165,866
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$
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3.51
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1,432,148
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(1) |
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Our Board of Directors has granted options which are currently
outstanding for a former consultant. The Board of Directors
determines the number and terms of each grant (option exercise
price, vesting and expiration date). These grants were made on
7/12/2002 and 7/14/2003. |
Common
Stock Ownership by Directors and Executive Officers and
Principal Holders
Directors
and Executive Officers
The following table sets forth certain information, as of
March 1, 2011, regarding the beneficial ownership of the
common stock by (i) each director, including the Director
Nominees; (ii) each Executive Officer; (iii) all of
our directors and Executive Officers as a group. Applicable
percentage ownership is based on 52,076,602 shares of
Common Stock outstanding as of March 1, 2011. The number of
shares beneficially owned by each director or Executive Officer
is determined under the rules of the SEC, and the information is
not necessarily indicative of beneficial ownership for any other
purpose. Under these rules, beneficial ownership includes any
shares as to which the individual has the sole or shared voting
power (which includes power to vote, or direct the voting of,
such security) or investment power (which includes power to
dispose of, or direct the disposition of, such security). In
computing the number of shares beneficially owned by a person
and the percentage ownership of that person, shares of common
stock subject to options, warrants or convertible notes held by
that person that are currently exercisable or convertible into
Common Stock or will become exercisable or convertible into
common stock within 60 days after March 1, 2011 are
deemed outstanding, while such shares are not deemed outstanding
for purposes of computing percentage ownership of
118
any other person. Unless otherwise indicated, all persons named
as beneficial owners of common stock have sole voting power and
sole investment power with respect to the shares indicated as
beneficially owned:
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Common Shares
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Beneficially Owned
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Common Shares
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Percent
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Name and Address(a)
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(b)
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Underlying Options
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Of Class
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Michael R. Garone(e)
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160,000
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60,000
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*
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Gary Riley, DVM, Ph.D.
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110,500
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90,000
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*
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Nicholas J. Hart
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45,000
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45,000
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*
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Mark H. Rachesky, M.D.
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30,046,645
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(c)
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15,863,420
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(d)
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44.2
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%
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Timothy G. Rothwell
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16,666
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16,666
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*
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Michael Weiser, M.D.
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49,775
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46,000
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*
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John D. Harkey, Jr.
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49,775
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46,000
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*
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All directors and executive officers as a group
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30,478,360
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16,167,085
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45.2
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%
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* |
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Less than 1% |
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(a) |
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Unless otherwise specified, the address of each beneficial owner
is
c/o Emisphere
Technologies, Inc., 240 Cedar Knolls Road, Suite 200, Cedar
Knolls, New Jersey 07927. |
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(b) |
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The number of shares set forth for each Director and Executive
Officer consists of direct and indirect ownership of shares,
including stock options, deferred common share units, restricted
stock and, in the case of Dr. Rachesky, shares of common
stock that can be obtained upon conversion of convertible notes
and exercise of warrants, as further described in footnotes
(c) and (d) below. |
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(c) |
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This number consists of: |
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14,183,225 shares of common stock held for the accounts of
the following entities:
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5,006,013 shares held for the account of MHR Capital
Partners Master Account LP (Master Account)
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680,826 shares held for the account of MHR Capital Partners
(100) LP (Capital Partners (100))
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2,412,718 shares held for the account of MHR Institutional
Partners II LP (Institutional Partners II)
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6,078,370 shares held for the account of MHR Institutional
Partners IIA LP (Institutional Partners IIA)
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5,298 shares held directly by Mark H. Rachesky, M.D.
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6,923,667 shares of common stock that can be obtained by
the following entities upon conversion of the Convertible Notes,
including 355,653 shares of common stock issuable to the
following entities as payment for accrued but unpaid interest on
the Convertible Notes since the most recent interest payment
date (December 31, 2010) through the date that is
60 days after March 1, 2011:
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1,394,202 shares held by Master Account
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190,660 shares held by Capital Partners (100)
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1,517,005 shares held by Institutional Partners II
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3,821,800 shares held by Institutional Partners IIA
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8,900,753 shares of common stock that can be obtained by
the following entities upon exercise of warrants:
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2,122,000 shares held by Master Account
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290,135 shares held by Capital Partners (100)
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1,843,722 shares held by Institutional Partners II
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4,644,896 shares held by Institutional Partners IIA
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119
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7,000 shares of common stock that can be obtained by
Dr. Rachesky upon the exercise of currently vested stock
options at a price of $3.76 per share
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7,000 shares of common stock that can be obtained by
Dr. Rachesky upon the exercise of currently vested stock
options at a price of $3.79 per share
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25,000 shares of common stock that can be obtained by
Dr. Rachesky upon the exercise of currently vested stock
options at a price of $0.93 per share.
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MHR Advisors LLC (Advisors) is the general partner
of each of Master Account and Capital Partners (100), and, in
such capacity, may be deemed to beneficially own the shares of
common stock held for the accounts of each of Master Account and
Capital Partners (100). MHR Institutional Advisors II LLC
(Institutional Advisors II) is the general partner
of each of Institutional Partners II and Institutional
Partners IIA, and, in such capacity, may be deemed to
beneficially own the shares of common stock held for the
accounts of each of Institutional Partners II and
Institutional Partners IIA. MHR Fund Management LLC
(Fund Management) is a Delaware limited
liability company that is an affiliate of and has an investment
management agreement with Master Account, Capital Partners
(100), Institutional Partners II and Institutional Partners
IIA, and other affiliated entities, pursuant to which it has the
power to vote or direct the vote and to dispose or to direct the
disposition of the shares of common stock held by such entities
and, accordingly, Fund Management may be deemed to
beneficially own the shares of common stock held for the account
of each of Master Account, Capital Partners (100), Institutional
Partners II and Institutional Partners IIA.
Dr. Rachesky is the managing member of Advisors,
Institutional Advisors II, and Fund Management, and, in
such capacity, may be deemed to beneficially own the shares of
common stock held for the accounts of each of Master Account,
Capital Partners (100), Institutional Partners II and
Institutional Partners IIA.
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(d) |
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This number consists of (i) 6,923,667 shares of common
stock that can be obtained by Master Account, Capital Partners
(100), Institutional Partners II and Institutional Partners
IIA upon conversion of the Convertible Notes,
(ii) 8,900,753 shares of common stock that can be
obtained by Master Account, Capital Partners (100),
Institutional Partners II and Institutional Partners IIA
upon exercise of warrants, (iii) 39,000 shares of
common stock that can be obtained by Dr. Rachesky upon the
exercise of currently vested stock options. |
|
(e) |
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On February 28, 2011, Michael R. Garone was appointed as
Interim Chief Executive Officer of the Company. |
Principal
Holders of Common Stock
The following table sets forth information regarding beneficial
owners of more than five (5%) percent of the outstanding shares
of Common Stock as of March 1, 2011:
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Number of Shares
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Percent
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Name and Address
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Beneficially Owned
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Of Class(a)
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Bai Ye Feng
16A Li Dong Building
No. 9 Li Yuen Street East
Central, Hong Kong
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5,014,665
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(b)
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9.36
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%
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Mark H. Rachesky, M.D.
40 West 57th Street, 24th Floor
New York, NY 10019
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30,046,645
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(c)
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44.2
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%
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(a) |
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Applicable percentage ownership is based on
52,076,602 shares of Common Stock outstanding as of
March 1, 2011. In computing the number of shares
beneficially owned by a person and the percentage ownership of
that person, shares of Common Stock subject to options, warrants
or convertible notes held by that person that are currently
exercisable or convertible into Common Stock or will become
exercisable or convertible into Common Stock within 60 days
after March 1, 2011 are deemed outstanding, while such
shares are not deemed outstanding for purposes of computing
percentage ownership of any other |
120
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person. Information based on Amendment Number 3 to
Schedule 13-D
filed with the SEC on February 14, 2008. |
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(b) |
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Information based on Mr. Fengs
Schedule 13-G/A
filed with the SEC on February 8, 2011. Mr. Feng
beneficially owns an aggregate of 5,014,665 shares of
common stock, consisting of 3,220,665 shares of common
stock held by Mr. Feng, warrants to purchase up to
1,500,000 shares of common stock held by Mr. Feng, and
294,000 shares of common stock held by Lighthouse
Consulting Limited, a Hong Kong company of which Mr. Feng
is a principal and therefore may be deemed to be the beneficial
holder of the securities held by Lighthouse Consulting Limited. |
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(c) |
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Please refer to footnote c in the table under
Directors and Executive Officers (above). |
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ITEM 13.
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CERTAIN
RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR
INDEPENDENCE
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Related
Party Transaction Approval Policy
In February 2007, our Board of Directors adopted a written
related party transaction approval policy, which sets forth our
Companys polices and procedures for the review, approval
or ratification of any transaction required to be reported in
our filings with the SEC. The Companys policy with regard
to related party transactions is that all material transactions
non-compensation related are to be reviewed by the Audit
Committee for any possible conflicts of interest. The
Compensation Committee will review all material transactions
that are related to compensation. All related party transactions
approved by either the Audit Committee or Compensation Committee
shall be disclosed to the Board of Directors at the next meeting.
Employment
Agreement with Michael V. Novinski, Former President and Chief
Executive Officer
On April 6, 2007, the Company entered into an employment
agreement with Michael V. Novinski, setting forth the terms and
conditions of his employment as President and Chief Executive of
the Company (the Novinski Employment Agreement). The
Novinski Employment Agreement was for a term of three years,
renewable annually thereafter. Effective February 25, 2011,
the Company and Mr. Novinski mutually agreed not to renew
the Novinski Employment Agreement, and Mr. Novinski
resigned his employment with the Company. Under the Novinski
Employment Agreement, Mr. Novinski received a base salary
of $550,000 per year, less applicable local, state and federal
withholding taxes. Mr. Novinski was also granted options to
purchase 1,000,000 shares of the Companys common
stock; the exercise price for 500,000 of the shares was $3.19,
the fair market value of the common stock on the date of grant,
and the exercise price for the remaining 500,000 shares is
equal to two times the fair market value of the common stock on
the date of grant. At December 31, 2010, options to
purchase 1,000,000 shares were vested. In addition, he was
eligible for an annual cash bonus up to $550,000 (based on a
full calendar year). In view of the Companys current
liquidity constraints, the Committee determined, and
Mr. Novinski agreed, that he would be paid a $150,000 cash
bonus pursuant to his employment agreement with the Corporation
in respect of the Companys 2009 fiscal year (the
2009 Performance Bonus); additionally
Mr. Novinski received a one-time grant of options to
purchase 300,000 shares in connection with his compensation
for 2009. However, given the Companys current liquidity
constraints, the Compensation Committee, with the consent of
Mr. Novinski, agreed to defer the payment of the cash bonus
until such time as the Companys liquidity has stabilized
and it has sufficient funding to pay it. The Committee also
determined that Mr. Novinski would be paid a special
one-time cash bonus of $150,000 in connection with the
successful completion of a financing during 2009 (the 2009
Financing Bonus). However, in light of the Companys
current liquidity constraints, Mr. Novinski and the Company
also agreed to defer the payment of the $150,000 special cash
bonus until such time as the Companys liquidity has
stabilized and it has sufficient funding to pay it.
In accordance with the Novinski Employment Agreement and the
Separation and Release Agreement by and between the Company and
Mr. Novinski dated as of February 25, 2011 (the
Separation Agreement), the Company paid to
Mr. Novinski the 2009 Performance Bonus and the 2009
Financing Bonus, accrued but unpaid vacation benefits, and the
Company also agreed to pay its portion of
Mr. Novinskis COBRA health benefits for a certain
period of time as further set forth therein. Mr. Novinski
owns incentive stock options to
121
purchase an aggregate of 1,600,000 shares of common stock,
of which 1,500,000 have vested. The Separation Agreement also
provides that Mr. Novinskis 100,000 unvested stock
options will continue to vest in accordance with
Mr. Novinskis underlying option agreements and that
Mr. Novinski may exercise his vested stock options through
April 6, 2012. Under the terms of the Separation Agreement,
Mr. Novinski has agreed to provide consulting services to
the Company for a period of 18 months and has also agreed
to release the Company and certain affiliated parties from all
claims and liabilities under federal and state laws arising from
his relationship with the Company.
Agreement
with M. Gary I. Riley, Vice President on Non-Clinical
Development and Applied Biology
The Company has an agreement with M. Gary I. Riley (the
Riley Employment Agreement) by which, in the event
that there is a Change in Control (as defined in the Riley
Employment Agreement) during Mr. Rileys first
twenty-four months of employment at Emisphere resulting in
termination of employment during such twenty-four month period,
a severance amount, equivalent to one years base salary
(excluding bonus and relocation assistance), will be provided to
the executive. In the event there is a Change in Control after
Mr. Rileys first twenty-four months of employment, a
severance amount, equivalent to six months base salary,
will be provided to him.
In addition, in the event that there is a Change in Control
during Mr. Rileys employment at Emisphere resulting
in termination of employment, he shall receive, in addition to
the options already vested and subject to approval by the Board
of Directors, immediate vesting of all remaining options as set
forth in the Plan.
Agreement
with Nicholas J. Hart, Vice President, Strategy and
Development
The Company has an agreement with Nicholas J. Hart (the
Hart Employment Agreement) by which, in the event
that there is a Change in Control (as defined in the Hart
Employment Agreement) during Mr. Harts term of
employment at Emisphere resulting in termination of employment,
a severance amount, equivalent to six months base salary
(excluding bonus) will be provided to Mr. Hart.
In addition, in the event that there is a Change in Control
during his employment at Emisphere resulting in termination of
employment, he shall receive, in addition to the options already
vested and subject to approval by the Board of Directors,
immediate vesting of all remaining options as set forth in the
Plan.
Information
about Board of Directors
Our business is overseen by the Board of Directors. It is the
duty of the Board of Directors to oversee the Chief Executive
Officer and other senior management in the competent and ethical
operation of the Company on a
day-to-day
basis and to assure that the long-term interests of the
stockholders are being served. To satisfy this duty, our
directors take a proactive, focused approach to their position,
and set standards to ensure that the Company is committed to
business success through maintenance of the highest standards of
responsibility and ethics. The Board of Directors is kept
advised of our business through regular verbal or written
reports, Board of Directors meetings, and analysis and
discussions with the Chief Executive Officer and other officers
of the Company.
Members of the Board of Directors bring to us a wide range of
experience, knowledge and judgment. Our governance organization
is designed to be a working structure for principled actions,
effective decision-making and appropriate monitoring of both
compliance and performance.
The Board of Directors has affirmatively determined that
Mr. John D. Harkey, Jr., Dr. Mark H. Rachesky,
Mr. Timothy G. Rothwell, and Dr. Michael Weiser are
independent directors within the meaning of Rule 4200 of
the NASDAQ Marketplace Rules. The independent directors meet in
separate sessions at the conclusion of board meetings and at
other times as deemed necessary by the independent directors, in
the absence of Mr. Michael V. Novinski, the sole
non-independent director. Dr. Carter resigned from the
Board of Directors effective April 30, 2009.
Mr. Berger resigned the Board of Directors effective
October 23, 2009. Mr. Moch resigned from the Board of
Directors effective November 10, 2009. On February 28,
2011, Michael V. Novinski resigned as a director of the Company
and from his position as President and Chief Executive
122
Officer of the Company. None of the members of the Board of
Directors currently serve as Chairman; leadership of the Board
is provided through consensus of the directors. Matters are
explored in Committee and brought to the full Board for
discussion or action.
Committees
of the Board of Directors
The Board of Directors has established an Audit Committee, a
Compensation Committee and a Governance and Nominating
Committee. Each of the committees of the Board of Directors acts
pursuant to a separate written charter adopted by the Board of
Directors.
The Audit Committee is currently comprised of Mr. Harkey
(chairman), Mr. Rothwell and Dr. Weiser.
Mr. Rothwell became a member of the Audit Committee on
January 6, 2010. All members of the Audit Committee are
independent within the meaning of Rule 4200 of the NASDAQ
Marketplace Rules. The Board of Directors has determined that
Mr. Harkey is an Audit Committee financial
expert, within the meaning of Item 401(h) of
Regulation S-K.
The Audit Committees responsibilities and duties are
summarized in the report of the Audit Committee and in the Audit
Committee charter which is available on our website
(www.emisphere.com).
The Compensation Committee is currently comprised of
Dr. Weiser (chairman) and Dr. Rachesky. All members of
the Compensation Committee are independent within the meaning of
Rule 4200 of the NASDAQ Marketplace Rules, non-employee
directors within the meaning of the rules of the Securities and
Exchange Commission and outside directors within the
meaning set forth under Internal Revenue Code
Section 162(m). The Compensation Committees
responsibilities and duties are summarized in the report of the
Compensation Committee and in the Compensation Committee charter
also available on our website.
The Governance and Nominating Committee is currently comprised
of Dr. Weiser (chairman) and Dr. Rachesky. All members
of the Governance and Nominating Committee are independent
within the meaning of Rule 4200 of the NASDAQ Marketplace
Rules. The Governance and Nominating Committees
responsibilities and duties are set forth in the Governance and
Nominating Committee charter on our website. Among other things,
the Governance and Nominating Committee is responsible for
recommending to the board the nominees for election to our Board
of Directors and the identification and recommendation of
candidates to fill vacancies occurring between annual
stockholder meetings.
The table below provides membership information for each
committee of the Board of Directors during 2010:
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Governance
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Name
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Board
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Audit
|
|
Compensation
|
|
and Nominating
|
|
Michael V. Novinski(1)
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X
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Mark H. Rachesky, M.D.(2)
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X
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|
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X
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|
X
|
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Michael Weiser, M.D.(2)
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X
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|
X
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X
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*
|
|
|
X
|
*
|
John D. Harkey, Jr.(3)
|
|
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X
|
|
|
|
X
|
*
|
|
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|
|
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|
Timothy G. Rothwell(3)
|
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X
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|
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|
X
|
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|
|
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|
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|
|
|
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|
* |
|
Chair |
|
(1) |
|
On February 28, 2011, Michael V. Novinski resigned as a
director of the Company and from his position as President and
Chief Executive Officer of the Company. |
|
(2) |
|
Class III directors: Term as director is expected to expire
in 2011. |
|
(3) |
|
Class I directors: Term as director is expected to expire
in 2012. |
Board
Involvement in Risk Oversight
Our Board of Directors is responsible for oversight of the
Companys risk assessment and management process. We
believe risk can arise in every decision and action taken by the
Company, whether strategic or operational. Our comprehensive
approach is reflected in the reporting processes by which our
management
123
provides timely and fulsome information to the Board of
Directors to support its role in oversight, approval and
decision-making.
The Board of Directors closely monitors the information it
receives from management and provides oversight and guidance to
our management team concerning the assessment and management of
risk. The Board of Directors approves the Companys high
level goals, strategies and policies to set the tone and
direction for appropriate risk taking within the business.
The Board of Directors delegated to the Compensation Committee
basic responsibility for oversight of managements
compensation risk assessment, and that committee reports to the
board on its review. Our Board of Directors also delegated tasks
related to risk process oversight to our Audit Committee, which
reports the results of its review process to the Board of
Directors. The Audit Committees process includes a review,
at least annually, of our internal audit process, including the
organizational structure, as well as the scope and methodology
of the internal audit process. The Governance and Nominating
Committee oversees risks related to our corporate governance,
including director performance, director succession, director
education and governance documents.
In addition to the reports from the Board committees, our board
periodically discusses risk oversight.
Meetings
Attendance
During the 2010 fiscal year, our Board of Directors held 5
meetings. With the exception of Mr. Harkey, who attended 3
of 4 Audit Committee meetings held during 2010, each director
attended 100 percent of the aggregate number of Board of
Directors meetings and committee meetings of which he was a
member that were held during the period of his service as a
director.
The Audit Committee met 4 times during the 2010 fiscal year.
The Compensation Committee met 1 time during the 2010 fiscal
year.
The Governance and Nominating Committee met 1 time during the
2010 fiscal year.
The Company does not have a formal policy regarding attendance
by members of the Board of Directors at the Companys
annual meeting of stockholders, although it does encourage
attendance by the directors.
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|
ITEM 14.
|
PRINCIPAL
ACCOUNTANT FEES AND SERVICES
|
The following table presents fees for professional audit
services rendered by M&P for the audit of our annual
financial statements for the years ended December 31, 2010
and December 31, 2009, respectively, and fees billed for
other services rendered by M&P during the respective
periods.
|
|
|
|
|
|
|
|
|
Type of Fees
|
|
2010
|
|
|
2009
|
|
|
Audit Fees(1)
|
|
|
231,000
|
|
|
|
150,000
|
|
Audit-Related Fees(2)
|
|
|
8,000
|
|
|
|
|
|
Tax Fees(3)
|
|
|
23,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
262,300
|
|
|
|
150,000
|
|
|
|
|
(1) |
|
Audit fees for 2010 and 2009 were for professional services
rendered for the audit of the Companys financial
statements for the fiscal year, including attestation services
required under Section 404 of the Sarbanes-Oxley Act of
2002, and reviews of the Companys quarterly financial
statements included in its
Form 10-Q
filings. |
|
(2) |
|
Audit related fees are for services related to our registration
statement on Form S-1. |
|
(3) |
|
Tax consulting fees. |
124
The Audit Committee has determined that the non-audit services
provided by M&P during 2010 did not impair their
independence. All decisions regarding selection of independent
registered public accounting firms and approval of accounting
services and fees are made by our Audit Committee in accordance
with the provisions of the Sarbanes-Oxley Act of 2002 and
related SEC rules.
The Audit Committee pre-approves all audit and permissible
non-audit services provided by the independent registered public
accounting firm; these services may include audit services,
audit related services, tax services and other services. The
committee has adopted a policy for the pre-approval of services
provided by the independent registered public accounting firm,
where pre-approval is generally provided for up to one year and
any pre-approval is detailed as to the particular service or
category of services and is subject to a specific budget. For
each proposed service, the independent auditor is required to
provide detailed communication at the time of approval. The
committee may delegate pre-approval authority to one or more of
its members, who must report same to the Committee members at
the next meeting. The Audit Committee, after discussion with
M&P, agreed that any additional audit or tax service fees
could be paid by us, subject to the pre-approval of the Audit
Committee chairman.
The Audit Committee intends to select M&P to serve as
independent registered public accounting firm for the fiscal
year ending December 31, 2011.
PART IV
|
|
ITEM 15.
|
EXHIBITS AND
FINANCIAL STATEMENT SCHEDULES
|
(a) (1) Financial Statements
A list of the financial statements filed as a part of this
report appears on page 53.
(2) Financial Statement Schedules
Schedules have been omitted because the information required is
not applicable or is shown in the Financial Statements or the
corresponding Notes to the Financial Statements.
(3) Exhibits
A list of the exhibits filed as a part of this report appears on
pages 112 thru 116.
(b) See Exhibits listed under the heading
Exhibit Index set forth on page 112.
(c) Schedules have been omitted because the information
required is not applicable or is shown in the Financial
Statements or the corresponding Notes to the Financial
Statements.
125
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Emisphere Technologies,
Inc.
|
|
|
|
By:
|
/s/ Michael
R. Garone
|
Michael R. Garone
Interim Chief Executive Officer and
Chief Financial Officer
Date: March 31, 2011
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
|
|
Name and Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
/s/ Michael
R. Garone
Michael
R. Garone
|
|
(Principal Executive Officer and
Principal Financial and
Accounting Officer)
|
|
March 31, 2011
|
|
|
|
|
|
/s/ John
D. Harkey, Jr.
John
D. Harkey, Jr.
|
|
Director
|
|
March 31, 2011
|
|
|
|
|
|
/s/ Mark
H. Rachesky, M.D.
Mark
H. Rachesky, M.D.
|
|
Director
|
|
March 31, 2011
|
|
|
|
|
|
/s/ Timothy
G. Rothwell
Timothy
G. Rothwell
|
|
Director
|
|
March 31, 2011
|
|
|
|
|
|
/s/ Michael
Weiser, M.D.
Michael
Weiser, M.D.
|
|
Director
|
|
March 31, 2011
|
126
EXHIBIT INDEX
|
|
|
|
|
|
|
|
|
|
|
Incorporated
|
|
|
|
|
by Reference
|
Exhibit
|
|
|
|
(1)
|
|
3.1
|
|
Amended and restated Certificate of Incorporation of Emisphere
Technologies, Inc., as amended by the Certificate of Amendment
of Amended and Restated Certificate of Incorporation of
Emisphere Technologies, Inc., dated April 20, 2007
|
|
R
|
|
|
3.2(a)
|
|
Bylaws of Emisphere Technologies, Inc., as amended
December 7, 1998 and September 26, 2005
|
|
A, L
|
|
|
3.2(b)
|
|
Amendment to the Bylaws, as amended, of Emisphere Technologies,
Inc.
|
|
V
|
|
|
4.1
|
|
Restated Rights Agreement dated as of April 7, 2006 between
Emisphere Technologies, Inc. and Mellon Investor Services, LLC
|
|
P
|
|
|
10.1(a)
|
|
1991 Stock Option Plan, as amended
|
|
F
|
|
(2)
|
10.1(b)
|
|
Amendment to the 1991 Stock Option Plan
|
|
Q
|
|
(2)
|
10.2(a)
|
|
Stock Incentive Plan for Outside Directors, as amended
|
|
C
|
|
(2)
|
10.2(b)
|
|
Amendment to the Amended and Restated Stock Incentive Plan for
Outside Directors
|
|
Q
|
|
(2)
|
10.3(a)
|
|
Directors Deferred Compensation Stock Plan
|
|
E
|
|
(2)
|
10.3(b)
|
|
Amendment to the Directors Deferred Compensation Stock Plan
|
|
Q
|
|
(2)
|
10.4(a)
|
|
Employee Stock Purchase Plan, as amended
|
|
B
|
|
(2)
|
10.4(b)
|
|
Amendment to Emisphere Technologies, Inc. Employee Stock
Purchase Plan
|
|
H
|
|
(2)
|
10.5
|
|
Non-Qualified Employee Stock Purchase Plan
|
|
B
|
|
(2)
|
10.6(a)
|
|
1995 Non-Qualified Stock Option Plan, as amended
|
|
B
|
|
(2)
|
10.6(b)
|
|
Amendment to the 1995 Non-Qualified Stock Option Plan
|
|
Q
|
|
(2)
|
10.7(a)
|
|
Emisphere Technologies, Inc. 2000 Stock Option Plan
|
|
G
|
|
(2)
|
10.7(b)
|
|
Amendment to Emisphere Technologies, Inc. 2000 Stock Option Plan
|
|
Q
|
|
(2)
|
10.8(a)
|
|
Emisphere Technologies, Inc. 2002 Broadbased Stock Option Plan
|
|
H
|
|
(2)
|
10.8(b)
|
|
Amendment to Emisphere Technologies, Inc. 2002 Broadbased Stock
Option Plan
|
|
Q
|
|
(2)
|
10.9
|
|
Emisphere Technologies, Inc. 2007 Stock Award and Incentive Plan
|
|
R
|
|
(2)
|
10.10
|
|
Amended and Restated Employment Agreement, dated April 28,
2005, between Michael M. Goldberg and Emisphere Technologies,
Inc.
|
|
N
|
|
(2)
|
10.11
|
|
Stock Option Agreements, dated January 1, 1991,
February 15, 1991, December 1, 1991, August 1,
1992 and October 6, 1995 between Michael M. Goldberg and
Emisphere Technologies, Inc.
|
|
B
|
|
(2)(3)
|
10.12
|
|
Stock Option Agreement, dated July 31, 2000, between
Michael M. Goldberg and Emisphere Technologies, Inc.
|
|
G
|
|
(2)
|
10.13
|
|
Employment Agreement dated April 6, 2007 between Michael V.
Novinski and Emisphere Technologies, Inc.
|
|
S
|
|
(2)
|
10.14
|
|
Nonqualified Stock Option Agreement dated April 6, 2007
between Michael V. Novinski and Emisphere Technologies,
Inc.
|
|
R
|
|
(2)
|
10.15
|
|
Incentive Stock Option Agreement dated February 12, 2007
between Lewis H. Bender and Emisphere Technologies, Inc.
|
|
R
|
|
(2)
|
10.16
|
|
Form of Nonqualified Stock Option Agreement
|
|
R
|
|
(2)
|
10.17
|
|
Form of Incentive Stock Option Agreement
|
|
R
|
|
(2)
|
10.18
|
|
Form of Restricted Stock Option Agreement
|
|
R
|
|
(2)
|
10.23
|
|
Research Collaboration and Option Agreement dated as of
December 3, 1997 between Emisphere Technologies, Inc. and
Novartis Pharma AG
|
|
D
|
|
(3)
|
10.24
|
|
License Agreement dated as of September 23, 2004 between
Emisphere Technologies, Inc. and Novartis Pharma AG, as amended
on November 4, 2005
|
|
J
|
|
(3)
|
127
|
|
|
|
|
|
|
|
|
|
|
Incorporated
|
|
|
|
|
by Reference
|
Exhibit
|
|
|
|
(1)
|
|
10.25(a)
|
|
Research Collaboration Option and License Agreement dated
December 1, 2004 by and between Emisphere Technologies,
Inc. and Novartis Pharma AG
|
|
J
|
|
(3)
|
10.25(b)
|
|
Convertible Promissory Note due December 1, 2009 issued to
Novartis Pharma AG
|
|
J
|
|
(3)
|
10.25(c)
|
|
Registration Rights Agreement dated as of December 1, 2004
between Emisphere Technologies, Inc. and Novartis Pharma AG
|
|
J
|
|
|
10.26
|
|
Development and License Agreement between Genta Incorporated and
Emisphere Technologies, Inc., dated March 22, 2006
|
|
O
|
|
|
10.27(a)
|
|
Senior Secured Loan Agreement between Emisphere Technologies,
Inc. and MHR, dated September 26, 2005, as amended on
November 11, 2005
|
|
L
|
|
|
10.27(b)
|
|
Investment and Exchange Agreement between Emisphere
Technologies, Inc. and MHR, dated September 26, 2005
|
|
L
|
|
|
10.27(c)
|
|
Pledge and Security Agreement between Emisphere Technologies,
Inc. and MHR, dated September 26, 2005
|
|
L
|
|
|
10.27(d)
|
|
Registration Rights Agreement between Emisphere Technologies,
Inc. and MHR, dated September 26, 2005
|
|
L
|
|
|
10.27(e)
|
|
Amendment No. 1 to the Senior Secured Term Loan Agreement,
dated November 11, 2005
|
|
M
|
|
|
10.27(f)
|
|
Form of 11% Senior Secured Convertible Note
|
|
L
|
|
|
10.27(g)
|
|
Form of Amendment to 11% Senior Secured Convertible Note
|
|
R
|
|
|
10.28
|
|
Warrant dated as of September 23, 2005 between Emisphere
Technologies, Inc. and MHR Capital Partners (100) LP
|
|
Q
|
|
|
10.29
|
|
Warrant dated as of September 23, 2005 between Emisphere
Technologies, Inc. and MHR Capital Partners (500) LP
|
|
Q
|
|
|
10.30
|
|
Warrant dated as of September 21, 2006 between Emisphere
Technologies, Inc. and MHR Institutional Partners IIA LP
|
|
Q
|
|
|
10.31
|
|
Warrant dated as of September 21, 2006 between Emisphere
Technologies, Inc. and MHR Institutional Partners II LP
|
|
Q
|
|
|
10.32
|
|
Warrant adjustment notice between Emisphere Technologies, Inc.
and MHR Capital Partners (100) LP, MHR Capital Partners
Master Account, LP (formerly MHR Capital Partners
(500) LP), MHR Institutional Partners IIA LP, MHR
Institutional Partners II LP, MHR Capital Partners
(100) LP and MHR Capital Partners Master Account LP
|
|
W
|
|
|
10.33
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and SF Capital Partners, Ltd.
|
|
W
|
|
|
10.34
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and Option Opportunities Corp.
|
|
W
|
|
|
10.35
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and Option Opportunities Corp.
|
|
W
|
|
|
10.36
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and Montaur Capital/Platinum Life Montaur
Life Sciences Fund I LLC
|
|
W
|
|
|
10.37
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and MHR Institutional Partners II LP
|
|
W
|
|
|
10.38
|
|
Warrant dated as of August 22, 2007 between Emisphere
Technologies, Inc. and MHR Institutional Partners IIA LP
|
|
W
|
|
|
10.39
|
|
Emisphere Technologies, Inc. Mankind Corporation
Patent Purchase Agreement, dated February 8, 2008
|
|
X
|
|
|
10.40
|
|
Development and License Agreement, dated as of June 21,
2008, between Emisphere Technologies, Inc. and Novo Nordisk AS.
|
|
Y
|
|
(3)
|
128
|
|
|
|
|
|
|
|
|
|
|
Incorporated
|
|
|
|
|
by Reference
|
Exhibit
|
|
|
|
(1)
|
|
10.41
|
|
Lease Termination Agreement, date April 29,2009, between
Emisphere Technologies, Inc. and
BMR-LANDMARK
AT EASTVIEW LLC
|
|
Z
|
|
|
10.42
|
|
Form of Non-Employee Director Non-Qualified Stock Option
Agreement
|
|
AA
|
|
(2)
|
10.43
|
|
Placement Agency Agreement dated as of August 19, 2009,
Between Emisphere Technologies, Inc. and Rodman &
Renshaw, LLC
|
|
BB
|
|
|
10.44
|
|
Securities Purchase Agreement dated as of August 19, 2009,
between Emisphere Technologies and the Purchasers named therein
|
|
BB
|
|
|
10.45
|
|
Securities Purchase Agreement dated as of August 19, 2009,
between Emisphere Technologies and MHR Fund Management, LLC
|
|
BB
|
|
|
10.46
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and MHR Capital Partners Master Account LP
|
|
CC
|
|
|
10.47
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and MHR Capital Partners (100) LP
|
|
CC
|
|
|
10.48
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and MHR Institutional Partners II LP
|
|
CC
|
|
|
10.49
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and MHR Institutional Partners IIA LP
|
|
CC
|
|
|
10.50
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and Rodman & Renshaw, LLC
|
|
CC
|
|
|
10.51
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and Benjamin Bowen
|
|
CC
|
|
|
10.52
|
|
Warrant dated as of August 21, 2009 between Emisphere
Technologies, Inc. and Noam Rubinstein
|
|
CC
|
|
|
10.53
|
|
Warrant adjustment notice between Emisphere Technologies, Inc.
and Elan International Services, Ltd. dated October 20, 2009
|
|
CC
|
|
|
10.54
|
|
Agreement to Extend the Maturity Date of the Convertible
Promissory Note Due December 1, 2009, between Emisphere
Technologies and Novartis Pharma AG dated November 25, 2009
|
|
EE
|
|
|
10.55
|
|
Agreement to Extend the Maturity Date of the Convertible
Promissory Note Due December 1, 2009, between Emisphere
Technologies and Novartis Pharma AG dated February 23, 2010
|
|
EE
|
|
|
10.56
|
|
Form of Incentive Stock Option Agreement under the Emisphere
Technologies, Inc. 2007 Stock Award and Incentive Plan
|
|
FF
|
|
|
10.57
|
|
Form of Non-Qualified Stock Option Agreement under the Emisphere
Technologies, Inc. 2007 Stock Award and Incentive Plan
|
|
FF
|
|
|
10.58
|
|
Letter Agreement by and between Emisphere Technologies, Inc. and
MHR Institutional Partners IIA LP, dated June 8, 2010
|
|
GG
|
|
|
10.59
|
|
Form of Emisphere Technologies, Inc. Reimbursement Note
|
|
GG
|
|
|
10.60
|
|
Form of Emisphere Technologies, Inc. Second Reimbursement Note
|
|
GG
|
|
|
10.61
|
|
Research Master Agreement and Amendment by and between Emisphere
Technologies, Inc. and Novartis Pharma AG, effective as of
June 4, 2010
|
|
HH
|
|
(3)
|
10.62
|
|
Securities Purchase Agreement by and among Emisphere
Technologies, Inc. and the Buyers named therein, dated
August 25, 2010
|
|
II
|
|
|
10.63
|
|
Securities Purchase Agreement by and among Emisphere
Technologies, Inc. and the MHR Buyers named therein, dated
August 25, 2010
|
|
II
|
|
|
10.64
|
|
Waiver Agreement, by and among Emisphere Technologies, Inc. and
MHR, dated August 25, 2010
|
|
II
|
|
|
129
|
|
|
|
|
|
|
|
|
|
|
Incorporated
|
|
|
|
|
by Reference
|
Exhibit
|
|
|
|
(1)
|
|
10.65
|
|
Registration Rights Agreement by and among Emisphere
Technologies, Inc. and the Buyers named therein, dated
August 26, 2010
|
|
JJ
|
|
|
10.66
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Bai Ye Feng
|
|
JJ
|
|
|
10.67
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Anson Investments Master Fund LP
|
|
JJ
|
|
|
10.68
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Iroquois Master Fund, Ltd.
|
|
JJ
|
|
|
10.69
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Hudson Bay Master Fund Ltd.
|
|
JJ
|
|
|
10.70
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Cranshire Capital, L.P.
|
|
JJ
|
|
|
10.71
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and Freestone Advantage Partners, LP
|
|
JJ
|
|
|
10.72
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Capital Partners Master Account LP
|
|
JJ
|
|
|
10.73
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Capital Partners (100) LP
|
|
JJ
|
|
|
10.74
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Institutional Partners II LP
|
|
JJ
|
|
|
10.75
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Institutional Partners IIA LP
|
|
JJ
|
|
|
10.76
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Capital Partners Master Account LP
|
|
JJ
|
|
|
10.77
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Capital Partners (100) LP
|
|
JJ
|
|
|
10.78
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Institutional Partners II LP
|
|
JJ
|
|
|
10.79
|
|
Warrant dated as of August 26, 2010, between Emisphere
Technologies, Inc. and MHR Institutional Partners IIA LP
|
|
JJ
|
|
|
10.80
|
|
Development and License Agreement, dated December 20, 2010,
between Emisphere Technologies, Inc. and Novo Nordisk A/S
|
|
KK
|
|
(4)
|
14.1
|
|
Emisphere Technologies, Inc. Code of Business Conduct and Ethics
|
|
I
|
|
|
16.1
|
|
Letter from PricewaterhouseCoopers LLP to the Securities
Exchange Commission dated January 11, 2010
|
|
DD
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting
Firm McGladrey & Pullen, LLP
|
|
*
|
|
|
23.2
|
|
Consent of Independent Registered Public Accounting
Firm PricewaterhouseCoopers LLP
|
|
*
|
|
|
31.1
|
|
Certification Pursuant to
Rule 13a-14(a)
and 15d-14(a), as adopted pursuant to section 302 of the
Sarbanes-Oxley Act of 2002
|
|
*
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002
|
|
*
|
|
|
|
|
|
* |
|
Filed herewith |
|
(1) |
|
If not filed herewith, filed as an exhibit to the document
referred to by letter as follows: |
|
A. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended January 31, 1999 |
|
B. |
|
Annual Report on
Form 10-K
for the fiscal year ended July 31, 1995 |
130
|
|
|
C. |
|
Annual Report on
Form 10-K
for the fiscal year ended July 31, 1997 |
|
D. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended October 31, 1997 |
|
E. |
|
Annual Report on
Form 10-K
for the fiscal year ended July 31, 1998 |
|
F. |
|
Annual Report on
Form 10-K
for the fiscal year ended July 31, 1999 |
|
G. |
|
Annual Report on
Form 10-K
for the fiscal year ended July 31, 2000 |
|
H. |
|
Registration statement on
Form S-8
dated and filed on November 27, 2002 |
|
I. |
|
Annual Report on
Form 10-K
for the year ended December 31, 2003 |
|
J. |
|
Registration on
Form S-3/A
dated and filed February 1, 2005 |
|
K. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended March 31, 2005 |
|
L. |
|
Current Report on
Form 8-K,
filed September 30, 2005 |
|
M. |
|
Current Report on
Form 8-K,
filed November 14, 2005 |
|
N. |
|
Current Report on
Form 8-K
filed May 4, 2005 |
|
O. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended March 31, 2006 |
|
P. |
|
Current Report on
Form 8-K,
filed April 10, 2006 |
|
Q. |
|
Annual Report on
Form 10-K
for the fiscal year ended December 31, 2006 |
|
R. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended March 31, 2007 |
|
S. |
|
Current Report on
Form 8-K,
filed April 11, 2007 |
|
T. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended June 30, 2007 |
|
U. |
|
Current Report on
Form 8-K,
filed June 29, 2007 |
|
V. |
|
Current Report on
Form 8-K,
filed September 14, 2007 |
|
W. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended September 30, 2007 |
|
X. |
|
Annual Report on
Form 10-K
for the fiscal year ended December 31, 2007 |
|
Y. |
|
Current Report on
Form 8-K,
filed August 11, 2008 |
|
Z. |
|
Current Report on
Form 8-K,
filed May 5, 2009 |
|
AA. |
|
Current Report on
Form 8-K,
filed May 21, 2009 |
|
BB. |
|
Current Report on
Form 8-K,
filed August 20, 2009 |
|
CC. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended September 30, 2009 |
|
DD. |
|
Current Report on
Form 8-K,
filed January 12, 2010 |
|
EE. |
|
Annual Report on
Form 10-K
for the fiscal year ended December 31, 2009 |
|
FF. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended March 31, 2010 |
|
GG. |
|
Current Report on
Form 8-K,
filed June 8, 2010 |
|
HH. |
|
Quarterly Report on
Form 10-Q
for the quarterly period ended June 30, 2010 |
|
II. |
|
Current Report on
Form 8-K,
filed August 25, 2010 |
|
JJ. |
|
Registration Statement on
Form S-1,
filed on September 15, 2010 |
|
KK. |
|
Current Report on
Form 8-K,
filed on December 21, 2010 |
|
(2) |
|
Management contract or compensatory plan or arrangement |
|
(3) |
|
Confidential treatment has been granted for the redacted
portions of this agreement. A complete copy of this agreement,
including the redacted portions, has been filed separately with
the Securities and Exchange Commission. |
|
(4) |
|
Confidential treatment has been requested for the redacted
portions of this agreement. A complete copy of this agreement,
including the redacted portions, has been filed separately with
the Securities and Exchange Commission. |
131