Blueprint
Exhibit 99.1
Palatin Technologies, Inc. Reports Fourth Quarter and
Fiscal Year 2017 Results;
Teleconference and Webcast to be held on September 25,
2017
CRANBURY, NJ – September 25, 2017 – Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, today announced results for its fourth
quarter and fiscal year ended June 30, 2017.
Recent and Fiscal Year Significant Highlights
●
Bremelanotide
- Under development for Hypoactive
Sexual Desire Disorder (“HSDD”):
–
November
2016 reported positive Phase 3 clinical results - both pivotal
trials met the pre-specified co-primary efficacy endpoints of
improvement in desire and decrease in distress associated with low
sexual desire.
–
Closed
an exclusive North American license agreement with AMAG
Pharmaceuticals, Inc. (“AMAG”) to develop and
commercialize bremelanotide in February 2017.
■
Received
$60 million upfront payment
–
Entered into a collaboration and license agreement
with Shanghai Fosun
Pharmaceutical Industrial Development Co., Ltd., a subsidiary of
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun
Pharma”) in September 2017 for exclusive rights to develop
and commercialize bremelanotide in the territories of mainland
China, Taiwan, Hong Kong S.A.R. and Macau
S.A.R.
■
Will
receive $5 million upfront payment
–
Working
closely with AMAG on completing the tasks and activities necessary
to file a New Drug Application (“NDA”) with the Food
and Drug Administration (“FDA”).
–
Target
NDA filing with the FDA for early calendar year 2018.
–
U.S.
Patent 7,700,592 issued July 11, 2017, on methods of treating
female sexual dysfunction and HSDD with bremelanotide. The patent
will expire in November 2033.
"In the last year we made tremendous progress with our lead
development program, bremelanotide for HSDD. We met our Phase 3
co-primary endpoints and we licensed the North American rights to
AMAG and the China rights to Fosun Pharma. These were truly
transformational events for Palatin," said Carl Spana, Ph.D.,
President and Chief Executive Officer of Palatin Technologies. "In
addition to advancing the activities required to file an NDA for
bremelanotide with the FDA in early calendar year 2018, we are also
progressing with licensing discussions and negotiations with
multiple potential partners for other regions around the globe. We
are also excited to now be able to devote resources and attention
to our other development programs, which address indications such
as heart failure, ophthalmic disorders and inflammatory bowel
diseases using targeted, receptor-specific peptides which we
developed."
●
Financial Transactions:
–
August
2016, Palatin closed on an underwritten offering of units with
gross proceeds of $9.25 million, with net proceeds, after deducting
offering expenses, of approximately $8.5 million. Palatin
issued:
■
11,481,481
shares of common stock and ten-year prefunded Series I warrants to
purchase 2,218,045 shares of common stock at an exercise price of
$0.01 per share
■
Series
H warrants to purchase 10,274,646 shares of common stock at an
exercise price of $0.70 per share
–
December
2016, Palatin closed on an underwritten public offering of units
with gross proceeds of $16.5 million, with net proceeds, after
deducting offering expenses, of approximately $15.4 million.
Palatin issued:
■
25,384,616
shares of common stock and five year Series J warrants to purchase
12,692,310 shares of common stock at an exercise price of $0.80 per
share
Fourth Quarter and Fiscal 2017 Financial Results
Palatin reported net income of $13.3 million, or
$0.07 per basic and diluted share, for the quarter ended June 30,
2017, compared to a net loss of $(13.4) million, or $(0.09) per
basic and diluted share, for the same period in
2016.
The difference between the three months ended June 30, 2017 and
2016 was primarily attributable to the recognition of $33.9 million
in contract revenue pursuant to our license agreement with
AMAG.
For the year ended June 30, 2017, Palatin reported a net loss of
$(13.3) million, or $(0.07) per basic and diluted share compared to
a net loss of $(51.7) million, or $(0.33) per basic and diluted
share for the year ended June 30, 2016.
The decrease in net loss for the year ended June 30, 2017, compared
to the net loss for the year ended June 30, 2016, was primarily
attributable to the recognition of $44.7 million in contract
revenue pursuant to our license agreement with AMAG.
Revenue
For the quarter and year ended June 30, 2017, Palatin recognized
$33.9 million and $44.7 million, respectively, in contract revenue
related to our license agreement with AMAG.
There were no revenues recorded in the quarter or year ended June
30, 2016.
Operating Expenses
Total operating expenses for the quarter ended June 30, 2017 were
$19.6 million compared to $12.7 million for the comparable quarter
of 2016. For the year ended June 30, 2017, Palatin incurred $55.3
million of operating expenses, compared to $49.3 million for the
year ended June 30, 2016.
The increase in operating expenses was mainly attributable to the
continued progress of Phase 3 clinical trial and development of
bremelanotide for HSDD as well as to the professional services
incurred related to closing our license agreement with
AMAG.
Other Income/Expense
Total other expense, net, was $0.5 million for the quarter ended
June 30, 2017, compared to $0.6 million for the quarter ended June
30, 2016. For the year ended June 30, 2017, total other expense,
net, was $2.3 million, compared to $2.5 million for the year ended
June 30, 2016. Total other expense, net for both fiscal year ended
June 30, 2017 and June 30, 2016 consisted mainly of interest
expense related to venture debt.
Income Tax
Income tax expense was $0.5 million for the quarter and year ended
June 30, 2017 compared to no income tax expense or benefit for the
quarter and year ended June 30, 2016. Income tax expense relates to
alternative minimum tax which results from the accelerated
recognition of revenue related to the AMAG agreement for tax
purposes. Alternative minimum tax is generated for fiscal year 2017
since NOLs can only offset 90 percent of our federal alternative
minimum taxable income.
Cash Position
Palatin’s cash, cash equivalents and investments were $40.5
million and accounts receivable was $15.1 million as of June 30,
2017, compared to cash, cash equivalents and investments of $9.4
million, and no accounts receivable, at June 30, 2016. Current
liabilities were $19.9 million, net of deferred revenue of $35.1
million, as of June 30, 2017, compared to $13.9 million as of June
30, 2016.
Palatin believes that existing
capital resources, along with the additional proceeds from our
September 2017 license agreement with Fosun Pharma, will be
adequate to fund our planned operations through at least calendar
year 2018.
Palatin Drug Discovery Programs
In the conference call and webcast, management will discuss next
steps in Palatin's portfolio of drug development programs. These
include Palatin’s melanocortin receptor1 and receptor-5
agonist peptides for treatment of inflammatory indications,
natriuretic peptide receptorA agonist compounds for treatment
of cardiovascular and pulmonary indications.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on September
25, 2017 at 11:00 a.m. Eastern Time to discuss the results of
operations in greater detail and provide an update on corporate
developments. Individuals interested in listening to the conference
call live can dial 1-866-548-4713 (U.S./Canada) or 1-323-794-2093
(international), conference ID 6109932. The audio webcast and
replay can be accessed by logging on to the
“Investor/Webcasts” section of Palatin’s website
at http://www.palatin.com. A telephone and webcast replay will be
available approximately one hour after the completion of the call.
To access the telephone replay, dial 1-888-203-1112 (U.S./Canada)
or 1-719-457-0820 (international), passcode 6109932. The webcast
and telephone replay will be available through October 2,
2017.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential. Palatin’s strategy is to develop
products and then form marketing collaborations with industry
leaders in order to maximize their commercial potential. For
additional information regarding Palatin, please visit
Palatin’s website at www.Palatin.com.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin
Technologies, Inc., such as statements about clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates and market potential for product candidates,
are “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and as that term is defined in the
Private Securities Litigation Reform Act of 1995. Palatin intends
that such forward-looking statements be subject to the safe harbors
created thereby. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that could cause
Palatin’s actual results to be materially different from its
historical results or from any results expressed or implied by such
forward-looking statements. Palatin’s actual results may
differ materially from those discussed in the forward-looking
statements for reasons including, but not limited to, results of
clinical trials, regulatory actions by the FDA and the need for
regulatory approvals, Palatin’s ability to fund development
of its technology and establish and successfully complete clinical
trials, the length of time and cost required to complete clinical
trials and submit applications for regulatory approvals, products
developed by competing pharmaceutical, biopharmaceutical and
biotechnology companies, commercial acceptance of Palatin’s
products, and other factors discussed in Palatin’s periodic
filings with the Securities and Exchange Commission. Palatin is not
responsible for updating for events that occur after the date of
this press release.
Investor Inquiries:
|
|
Media Inquiries:
|
Stephen T. Wills, CPA, MST
|
|
Paul
Arndt, MBA, LifeSci Advisors
|
CFO/COO (609) 495-2200
|
|
Managing Director (646) 597-6992
|
Info@Palatin.com
|
|
Paul@LifeSciAdvisors.com
|
###
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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REVENUES
|
|
|
|
License and
contract
|
$44,723,827
|
$-
|
$12,951,730
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
Research and
development
|
45,683,174
|
43,071,051
|
24,560,233
|
General and
administrative
|
9,610,147
|
6,179,084
|
5,677,654
|
Total operating
expenses
|
55,293,321
|
49,250,135
|
30,237,887
|
|
|
|
|
Loss from
operations
|
(10,569,494)
|
(49,250,135)
|
(17,286,157)
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
Investment
income
|
26,270
|
50,226
|
35,439
|
Interest
expense
|
(2,288,309)
|
(2,513,027)
|
(661,697)
|
Foreign exchange
transaction loss
|
-
|
-
|
(284,656)
|
Total other
expense, net
|
(2,262,039)
|
(2,462,801)
|
(910,914)
|
|
|
|
|
Loss before income
taxes
|
(12,831,533)
|
(51,712,936)
|
(18,197,071)
|
Income tax
(expense) benefit
|
(500,000)
|
-
|
531,508
|
|
|
|
|
NET
LOSS
|
$(13,331,533)
|
$(51,712,936)
|
$(17,665,563)
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.07)
|
$(0.33)
|
$(0.15)
|
|
|
|
|
Weighted average
number of common shares outstanding used in computing basic and
diluted net loss per common share
|
184,087,719
|
156,553,534
|
121,014,506
|
PALATIN TECHNOLOGIES, INC.
|
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Consolidated
Balance Sheets
|
|
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ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$40,200,324
|
$8,002,668
|
Available-for-sale
investments
|
249,837
|
1,380,556
|
Accounts
receivable
|
15,116,822
|
-
|
Prepaid expenses
and other current assets
|
1,011,221
|
1,313,841
|
Total current
assets
|
56,578,204
|
10,697,065
|
|
|
|
Property and
equipment, net
|
198,153
|
97,801
|
Other
assets
|
56,916
|
63,213
|
Total
assets
|
$56,833,273
|
$10,858,079
|
|
|
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LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$1,551,367
|
$713,890
|
Accrued
expenses
|
10,521,098
|
7,767,733
|
Notes payable, net
of discount
|
7,824,935
|
5,374,951
|
Capital lease
obligations
|
14,324
|
27,424
|
Deferred
revenue
|
35,050,572
|
-
|
Total current
liabilities
|
54,962,296
|
13,883,998
|
|
|
|
Notes payable, net
of discount
|
6,281,660
|
14,106,594
|
Capital lease
obligations
|
-
|
14,324
|
Other non-current
liabilities
|
753,961
|
439,130
|
Total
liabilities
|
61,997,917
|
28,444,046
|
|
|
|
Stockholders’
deficiency:
|
|
|
Preferred stock of
$0.01 par value – authorized 10,000,000 shares:
|
|
|
Series A
Convertible: issued and outstanding 4,030 shares as of June 30,
2017 and June 30, 2016
|
40
|
40
|
Common stock of
$0.01 par value – authorized 300,000,000 shares;
|
|
|
issued and
outstanding 160,515,361 shares as of June 30, 2017 and 68,568,055
as of June 30, 2016, respectively
|
1,605,153
|
685,680
|
Additional paid-in
capital
|
349,974,538
|
325,142,509
|
Accumulated other
comprehensive loss
|
(590)
|
(1,944)
|
Accumulated
deficit
|
(356,743,785)
|
(343,412,252)
|
Total
stockholders’ deficiency
|
(5,164,644)
|
(17,585,967)
|
Total liabilities
and stockholders’ deficiency
|
$56,833,273
|
$10,858,079
|