-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Ne9/WcuRrK2C3eL0gSoIa2TbJsSHhXrO+VgZQIofCdOxOIe/sSvFGav2zmVvrCds yBhAECNm5mW4HeUeRRpuLA== 0001193125-08-055121.txt : 20080313 0001193125-08-055121.hdr.sgml : 20080313 20080313124144 ACCESSION NUMBER: 0001193125-08-055121 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20071231 FILED AS OF DATE: 20080313 DATE AS OF CHANGE: 20080313 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CURAGEN CORP CENTRAL INDEX KEY: 0001030653 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 061331400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23223 FILM NUMBER: 08685550 BUSINESS ADDRESS: STREET 1: 322 EAST MAIN STREET CITY: BRANFORD STATE: CT ZIP: 06405 BUSINESS PHONE: 203 481 1104 MAIL ADDRESS: STREET 1: 322 EAST MAIN STREET CITY: BRANFORD STATE: CT ZIP: 06405 10-K 1 d10k.htm FORM 10-K Form 10-K
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-K

(Mark One)

 

x ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2007

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

 

 

Commission File Number 000-23223

CURAGEN CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   06-1331400

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

322 East Main Street,

Branford, Connecticut

  06405
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (203) 481-1104

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Name of each exchange on which registered

Common Stock, $0.01 par value    NASDAQ Global Market
(excluding Preferred Stock Purchase Rights, $0.01 par value)   

Securities registered pursuant to Section 12(g) of the Act:

None

(Title of class)

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes  ¨ No  x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.  Yes  ¨  No  x

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 the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s 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.  x

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 definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  ¨        Accelerated filer  x         Non-accelerated filer  ¨        Smaller reporting company  ¨

(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 Exchange Act.).  Yes  ¨  No  x

The aggregate market value of the registrant’s voting shares of common stock held by non-affiliates of the registrant on June 29, 2007, based on $1.97 per share, the last reported sale price on the NASDAQ Global Market on that date, was $101,568,407.

The number of shares outstanding of the registrant’s common stock as of February 29, 2008 was 57,805,401.

Documents Incorporated by Reference

Portions of the Registrant’s definitive proxy statement for its 2008 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.

 

 

 


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CURAGEN CORPORATION

FORM 10-K

INDEX

 

         Page #
PART I

ITEM 1.

 

BUSINESS

   1

ITEM 1A.

 

RISK FACTORS

   13

ITEM 1B.

 

UNRESOLVED STAFF COMMENTS

   29

ITEM 2.

 

PROPERTIES

   29

ITEM 3.

 

LEGAL PROCEEDINGS

   29

ITEM 4.

 

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

   29
  PART II   

ITEM 5.

  MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES    30

ITEM 6.

 

SELECTED FINANCIAL DATA

   32

ITEM 7.

  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS    34

ITEM 7A.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

   48

ITEM 8.

 

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

   48

ITEM 9.

  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE    79

ITEM 9A.

 

CONTROLS AND PROCEDURES

   79

ITEM 9B.

 

OTHER INFORMATION

   80
  PART III   

ITEM 10.

 

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

   81

ITEM 11.

 

EXECUTIVE COMPENSATION

   81

ITEM 12.

  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS    81

ITEM 13.

  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE    81

ITEM 14.

 

PRINCIPAL ACCOUNTANT FEES AND SERVICES

   81
  PART IV   

ITEM 15.

 

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

   82


Table of Contents

PART I

 

Item 1. Business

Overview

We are a biopharmaceutical development company dedicated to improving the lives of patients by developing novel therapeutics for the treatment of cancer. Our financial and human resources are currently focused on advancing our cancer treatments, belinostat and CR011-vcMMAE, through clinical development and toward commercialization. In addition, we maintain a portfolio of earlier stage assets, including proteins, antibodies and small molecules that represent potential treatments for cancer.

We are a Delaware corporation. We were incorporated in 1991 and began operations in 1993. Our principal executive office is located at 322 East Main Street, Branford, Connecticut 06405.

We are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and, accordingly, file reports, proxy statements and other information with the Securities and Exchange Commission. Such reports, proxy statements and other information can be read and copied at the public reference facilities maintained by the Securities and Exchange Commission at the Public Reference Room, 100 F Street, N.E., Washington, D.C. 20549. Information regarding the operation of the Public Reference Room may be obtained by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange Commission maintains a web site (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with the Securities and Exchange Commission.

Our Internet address is www.curagen.com. We are not including the information contained on our web site as a part of, or incorporating it by reference into, this Annual Report on Form 10-K. We make available free of charge on our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission.

Strategy

Our goal is to generate value for our stockholders by focusing our resources on advancing our cancer treatments, belinostat and CR011-vcMMAE, through clinical development and towards commercialization. We are striving to become profitable by commercializing these therapeutics, which may include establishing partnerships with pharmaceutical and biotechnology companies for the development and commercialization of these therapeutics.

The following table summarizes our clinical drug development programs:

 

Product Candidate

 

Classification

 

Therapeutic Area

 

Development Status

Belinostat

  Small molecule   Cancer treatment   Phase II

CR011-vcMMAE

  Antibody-drug conjugate   Cancer treatment   Phase I/II

Belinostat for the Treatment of Cancer

Belinostat, previously referred to as PXD101, is a small molecule histone deactylase, or HDAC inhibitor. In June 2004, we added belinostat to our pipeline through a license and collaboration agreement with TopoTarget. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: arrest growth of cancer cells; induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis, or the growth of blood vessels; and sensitize cancer cells to overcome drug resistance. We are currently evaluating an intravenous and oral formulation of belinostat as a potential treatment for solid tumors and hematologic malignancies either alone or in combination with other anti-cancer therapies.

 

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CuraGen-Sponsored Belinostat Clinical Development Program

We are currently conducting a broad development program evaluating intravenous and oral belinostat for:

 

Indication

  

Phase

  

Regimen

  

Initiation of Patient

        Enrollment        

  

Status

T-cell lymphomas

   II    Monotherapy    January 2006    Enrollment ongoing. Updated results anticipated in the first half of 2008.

Ovarian cancer

   II    Combination with

paclitaxel and/or

carboplatin

   November 2006    Enrollment complete. Updated results anticipated in the first half of 2008.

Bladder cancer

   II    Combination with

paclitaxel and/or

carboplatin

   June 2007    Enrollment ongoing.

Solid tumors

   Ib    Combination with

5-fluorouracil

(“5-FU”)

   September 2005    Enrollment ongoing.

Soft tissue sarcoma

   I/II    Combination with
doxorubicin
   May 2007    Enrollment ongoing.

Acute myeloid leukemia

   I/II    Combination with
idarubicin
   August 2007    Enrollment ongoing.

Advanced solid tumors

   I    Oral belinostat
monotherapy
   August 2006    Enrollment ongoing.

Multiple myeloma

   II    Monotherapy or
in combination
with
dexamethasone
   January 2005    Enrollment complete. Results presented December 2006.

Multiple myeloma

   Ib    Combination with
Velcade®
   March 2006    Enrollment terminated March 2007.

Multiple myeloma

   Ib    Combination with

Velcade®

   March 2007    Enrollment terminated August 2007.

Phase II Trial Results for the Treatment of T-cell Lymphoma

In December 2007, we provided a clinical and regulatory update on intravenous belinostat for the treatment of patients with T-cell lymphoma including peripheral T-cell lymphoma, or PTCL, and cutaneous T-cell lymphoma, or CTCL. Updated preliminary results on a total of 32 patients, consisting of 12 patients with PTCL and 20 patients with CTCL, were presented. Two of 10 evaluable patients with PTCL achieved a complete response, or CR, and four additional patients had stable disease, or SD, lasting a median of 14 weeks (range 12-23 weeks). Assessments for duration of response are ongoing with CR durations of 18 and 21 weeks at the time of presentation. In addition, three of 19 evaluable patients with CTCL achieved an objective response, including one CR and two partial responses, and an additional 8 patients had SD. The CR duration is beyond 55 weeks with follow-up assessments ongoing. 71% of patients had an improvement in skin burden of CTCL as demonstrated by a decrease in Severity-Weighted Assessment Tool, or SWAT score. Enrollment is continuing into the study with a target of approximately 34 patients for each type of lymphoma. We anticipate that updated interim results from this trial will be reported during the second quarter of 2008.

 

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We also announced in December 2007 that the preliminary PTCL results from the ongoing Phase II trial were submitted to the U.S. Food and Drug Administration, or FDA, as part of an End-of-Phase II meeting held on November 29, 2007. Based on the meeting with the FDA, we plan to submit a clinical trial protocol to the FDA under a Special Protocol Assessment, or SPA, and anticipate initiating a registrational clinical trial for PTCL during the second half of 2008. We currently anticipate that the registrational trial will be an uncontrolled, open-label clinical trial that will enroll approximately 80 to 100 patients with a primary endpoint of objective response rate and secondary endpoints including duration of response, progression free survival, and overall survival.

Phase II Trial Results for the Treatment of Ovarian Cancer

In October 2007, we provided an update on clinical trial results that were presented on intravenous and oral belinostat at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Updated Phase II results from our ongoing Phase II open-label trial evaluating a dose regimen consisting of belinostat in combination with carboplatin and paclitaxel, referred to as BelCaP, were reported in October 2007. Data on 23 patients, including efficacy data for 16 patients who had available pre- and post-baseline assessments of tumor, suggested BelCaP was generally well tolerated in patients with relapsed ovarian cancer. Reduction in tumor size was seen in 15 of 16 patients by radiologic assessment. As of the date of presentation, objective responses by Response Evaluation Criteria in Solid Tumors, or RECIST, were observed in 8 patients, including 2 confirmed partial responses and 6 additional responses that were pending radiologic confirmation. Thirteen additional patients had treatment ongoing with continued radiologic assessment of tumor to determine best response. Enrollment in this trial has been completed and we anticipate that results will be reported during the second quarter of 2008.

Phase I Monotherapy Results with Intravenous Belinostat

In November 2005, we reported results from a Phase I trial on intravenous belinostat as a single agent for the treatment of advanced solid tumors. Results from a total of 42 patients suggested that the most common adverse events were fatigue, nausea, vomiting and phlebitis, or vein inflammation, with no significant hematological toxicities noted. Based on the dose-escalation safety data, the dose of intravenous belinostat for Phase II monotherapy efficacy studies was determined to be 1000 mg/m2 for five days every three weeks. In December 2005, we reported safety and clinical activity results from a Phase I trial on intravenous belinostat for the treatment of advanced hematologic tumors. In this trial, belinostat was generally well-tolerated with the most common adverse events being fatigue, nausea and vomiting.

Phase I Results of Intravenous Belinostat in Combination

Results from our Phase Ib dose-escalation trial evaluating intravenous belinostat in combination with paclitaxel and carboplatin for advanced solid tumors were reported in November 2006. The data from the 23 patients treated demonstrated that belinostat was well-tolerated when administered in combination with standard doses of carboplatin and paclitaxel, with no dose limiting toxicities encountered and no grade 4 adverse events noted. This trial was advanced into a Phase II study evaluating the combination of intravenous belinostat in combination with paclitaxel and carboplatin for the treatment of patients with recurrent ovarian cancer, which is discussed below.

In June 2007, we reported Phase Ib dose-escalation results evaluating intravenous belinostat in combination with 5-fluorouracil, or 5-FU. Results on 25 patients with advanced solid tumors indicated that the combination of intravenous belinostat plus 5-FU is generally well tolerated. Two dose limiting toxicities, including one Grade 3 stomatitis and one Grade 3 angina were reported in the highest dose group evaluating 1000 mg/m2 /day belinostat plus 1000 mg/m2/day 5-FU. Of the 23 evaluable patients, a total of seven patients achieved SD (range 2 – 8 cycles), with two patients on treatment as of June 2007, and no objective responses noted. As of March 2008, enrollment is being completed in this trial to determine whether belinostat in combination with 5-FU has any effect on the expression of thymidylate synthase in tumor tissue, although further development of this combination regimen is currently not anticipated.

 

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In August 2007, we also announced that we were preparing to initiate a Phase I/II clinical trial evaluating belinostat in combination with the idarubicin for the treatment of acute myelogenous leukemia, or AML. The study is being conducted at multiple sites in the European Union. Up to 70 patients will be enrolled and will receive intravenous treatment in one of two regimens. Patients will either receive intravenous belinostat administered once daily for five days in combination with idarubicin or a continuous infusion of belinostat with or without idarubicin. Enrollment into the treatment arms is occurring in parallel to define the maximum tolerated dose, or MTD, for each treatment regimen.

Phase I Results with Oral Belinostat

In October 2007, we reported initial results from our ongoing Phase I open-label, multi-center dose-escalation trial evaluating oral belinostat. The goal of the study is to establish the MTD for oral belinostat administered once or twice daily in one of two regimens (either continuous daily dosing or dosing days one through 14 in a 21-day cycle). Data were available on 60 patients enrolled into the dose-escalation study with 46 patients on the continuous daily regimen and 14 patients dosed days one through 14 in a 21-day cycle. The most frequent adverse events reported were fatigue, anorexia and nausea. More than 2,400 ECGs were collected in this trial, with no grade 3 or 4 QTc changes noted at the time of presentation. Fifteen patients (25%) achieved SD for greater than or equal to 12 weeks, with no RECIST-defined objective responses reported. Dose-escalation performed with 250 mg capsules of oral belinostat resulted in a presumptive continuous dosing MTD of 250 mg twice daily. The MTD for dosing of oral belinostat on days one through 14 in a 21-day cycle has not yet been reached.

Phase II Trial Results for the Treatment of Multiple Myeloma

In December 2006, results from our Phase II trial evaluating intravenous belinostat for the treatment of multiple myeloma, either alone or in combination with dexamethasone, were presented. The Phase II trial enrolled a total of 25 patients, of which 21 were eligible to be evaluated for single agent clinical activity. Preliminary results indicated that nine patients (43%) receiving belinostat monotherapy achieved SD, lasting from one to ten cycles. Patients with progressive disease following treatment with belinostat monotherapy were eligible to receive belinostat in combination with dexamethasone. Of the eight evaluable patients treated with this combination, an objective response rate of 50% was achieved including two partial response and two minimal responses, and four additional patients achieving SD lasting two to 15 cycles, with two of these patients continuing to receive belinostat and dexamethasone. In this trial, belinostat, both alone and in combination with dexamethasone, was well tolerated.

We have also evaluated the combination of intravenous belinostat with Velcade® (bortezomib) for the treatment of patients with advanced, refractory multiple myeloma. In August 2007, we announced that we had halted enrollment into this Phase II open-label clinical trial. Two out of four patients enrolled in the study developed acute renal insufficiency, or ARI, in the first cycle of treatment with the combination. Three similar events of ARI were previously reported from studies evaluating belinostat monotherapy in patients with multiple myeloma. To date, no ARI has been observed in any other indication for which intravenous or oral belinostat is being evaluated. Further development of belinostat, either alone or combination, for the treatment of multiple myeloma is not currently anticipated.

NCI-Sponsored Belinostat Clinical Development Program

In August 2004, we signed a clinical trials agreement, or CTA, with the National Cancer Institute, or NCI, that provides us with access to the expertise at the NCI for the design, implementation, and monitoring of clinical trials with belinostat. Under the CTA, the NCI will sponsor a number of clinical trials evaluating the activity of belinostat, either alone or in combination with other anti-cancer therapies, for the treatment of solid and hematologic malignancies. NCI-sponsored clinical trials are occurring in parallel to those sponsored by us, with all data generated

 

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available for use in future product registration. As of March 2008, a total of ten NCI-sponsored trials were being conducted, enrolling patients at sites in the U.S. and abroad. Details of the NCI-sponsored trials are provided below.

 

Indication

  

Phase

  

Regimen

  

Initiation of Patient

        Enrollment        

Advanced solid tumors or lymphomas

   Ib    Combination with Velcade®    March 2006

Acute Myelogenous Leukemia

   II    Monotherapy    June 2006

Advanced solid tumors

   Ib    Combination with cis-retinoic acid    June 2006

Mesothelioma

   II    Monotherapy    June 2006

Hepatocellular carcinoma

   I/II    Monotherapy    July 2006

Advanced hematologic malignancies

   I    Combination with azacitidine    August 2006

B-cell lymphomas

   II    Monotherapy    August 2006

Ovarian Cancer

   II    Monotherapy    November 2006

Myelodysplastic syndrome

   II    Monotherapy    November 2006

Thymoma / thymic carcinoma

   II    Monotherapy    December 2007

During the 2007 AACR-NCI-EORTC International Conference in October 2007, results from two NCI-sponsored clinical trials evaluating intravenous belinostat as either monotherapy for the treatment of ovarian cancer or in combination with Velcade®, or bortezomib, for advanced solid tumors or lymphomas were presented.

Data from the ongoing Phase II open-label trial evaluating intravenous belinostat monotherapy on patients with either refractory or relapsed platinum resistant epithelial ovarian cancer, or EOC, or patients with micropapillary/borderline ovarian tumors, or LMP, were reported. During the presentation it was reported that belinostat was safe and generally well-tolerated in these two ovarian cancer populations. A total of patients with LMP tumors received a median of four treatment cycles (range one to 13), with one LMP patient achieving a partial response, or PR, one patient had a CA-125 response, nine had SD, and two were not evaluable. Six patients remain on study. Objective responses to belinostat monotherapy were not observed in a heavily pre-treated well-defined platinum-resistant population of patients with EOC.

Data on 17 patients, of which 14 were evaluable, were reported from an ongoing Phase I open-label, dose-escalation study evaluating intravenous belinostat in combination with bortezomib for the treatment of advanced solid tumors or lymphomas were also presented during the 2007 AACR-NCI-EORTC International Conference. Belinostat in combination with bortezomib was well tolerated at doses up to 600 mg/m2 belinostat and 1.3 mg/m2 bortezomib, with ongoing enrollment of patients into this dosing cohort. Activity of the combination reported included one patient with Ewing’s Sarcoma that has maintained SD for 4 cycles, and two patients, one with peritoneal cancer and one with appendiceal carcinoma, that have maintained SD for 3 cycles. Adverse events were generally grades 1-2 and reversible. No grade 4 non-hematologic toxicities were reported.

CR011-vcMMAE for the Treatment of Cancer

CR011 is a fully-human monoclonal antibody resulting from our collaboration with Amgen Fremont that utilizes antibody-drug conjugate, or ADC technology licensed from Seattle Genetics to attach monomethylauristatin E, or vcMMAE, to yield CR011-vcMMAE. CR011 targets glycoprotein NMB, or GPNMB, a protein located specifically on the surface of cells including melanoma. After CR011-vcMMAE binds to the target protein, the ADC is transported inside the cancer cell where MMAE is cleaved from the antibody and activated in the cell.

 

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In October 2004, we announced the advancement to preclinical development of CR011-vcMMAE, which we are investigating as a potential treatment for metastatic melanoma. Preclinical animal data on CR011-vcMMAE was presented in April 2005 at the 96th Annual Meeting of American Association for Cancer Research, or AACR. These results demonstrated that treatment of xenograft models of melanoma with CR011-vcMMAE caused significant improvements in survival, including complete and durable tumor regression, without any notable toxicity or weight loss.

Clinical Development Program

In June 2006, we announced the clearance by the FDA of the investigational new drug application, or IND, for CR011-vcMMAE and the initiation of dosing of patients in a Phase I/II clinical trial. We reported in October 2007 initial results from this ongoing open-label, multi-center, dose-escalation study that is evaluating the safety, tolerability and pharmacokinetics of CR011-vcMMAE for patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of chemotherapy. The first part of the trial has been evaluating cohorts of patients receiving increasing doses of CR011-vcMMAE to determine the MTD. In October 2007, we provided an update on clinical trial results at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Data on 25 patients treated with doses of up to 1.88 mg/kg CR011-vcMMAE administered intravenously once every three weeks were presented. CR011-vcMMAE has been generally well-tolerated with no dose limiting toxicities reported. Clinical activity reported included stable disease in six patients lasting four cycles or longer and four patients with reductions in tumor size of up to 20%. The dose escalation assessment of CR011-vcMMAE is ongoing with patients treated at doses up to 2.63 mg/kg.

After determination of the MTD, up to approximately 32 additional patients with advanced melanoma are expected to be enrolled and treated at the MTD to further define safety and activity of CR011-vcMMAE in the efficacy portion of the trial.

Velafermin for Cancer Supportive Care

Velafermin, also referred to as recombinant human fibroblast growth factor-20, or FGF-20, or CG53135, is a protein we were investigating for the prevention of oral mucositis in cancer patients receiving chemotherapy, with or without radiotherapy, for the treatment of their underlying disease. We announced in October 2007 that our Phase II dose-confirmatory clinical trial on velafermin, designated CLN-12, did not meet its primary endpoint. Based on these trial results, we have discontinued the development of velafermin. Patients from this study are being followed for approximately one year post treatment for protocol-specified safety monitoring and therefore the study will not be clinically complete until approximately September 2008. No new obligations will be initiated with this program.

Earlier Stage Assets

In addition to the clinical drug candidates outlined above, we also have a portfolio of preclinical protein, antibody, ADC and small molecule drug candidates that have been or are ready to be evaluated in animal studies. The majority these drug candidates are in the areas of oncology and inflammatory diseases.

Research and Development

Research and Development Expenses

Research and development expenses for the years ended 2007, 2006 and 2005 were $36.8 million, $44.0 million and $57.5 million, respectively. Our research and development expenses consist of investments in the manufacturing, preclinical evaluation and clinical development of our drug candidates including velafermin, belinostat and CR011-vcMMAE. For additional details regarding our research and development expenses, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included elsewhere in this Annual Report on Form 10-K.

 

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Strategic Collaborations

We have established a pipeline of potential therapeutics by collaborating with, and leveraging the capabilities of, industry leaders to more efficiently advance our programs, reduce risk and conserve resources. We have developed five classes of drug candidates: protein therapeutics; fully-human monoclonal antibody therapeutics, which were developed in collaboration with Amgen Fremont; small molecule therapeutics for oncology and inflammatory diseases, which are developed in collaboration with TopoTarget; ADCs, which are developed using antibodies generated by Amgen Fremont and ADC technology from Seattle Genetics; and small molecule therapeutics for diabetes and metabolic disorders, which were developed in collaboration with Bayer.

Amgen Fremont (formerly Abgenix)

In December 1999, we entered into a strategic collaboration with Abgenix to develop fully-human monoclonal antibody therapeutics. We amended and restructured this alliance in November 2000 and April 2004. The initial phase of the agreement, involving the identification of targets and the initiation of antibody generation, was completed in June 2005. In April 2006, Amgen Inc. acquired Abgenix, and assumed all obligations of the agreement. Under this agreement, we have advanced CR011-vcMMAE into clinical development. Under our agreement we are obligated to pay milestones to Amgen for the advancement of CR011-vcMMAE through clinical trials and regulatory approval. In addition, we are obligated to pay royalties to Amgen based upon Net Sales of CR011-vcMMAE once commercialized.

TopoTarget

In June 2004, we signed a license and collaboration agreement with TopoTarget to develop belinostat, a novel HDAC inhibitor for the treatment of solid and hematologic malignancies, and identify additional HDAC inhibitors from TopoTarget’s extensive library of compounds.

Under the terms of the agreement, we acquired the exclusive right to commercialize belinostat in all markets other than Europe, while TopoTarget has retained commercialization rights in Europe. We are obligated to fund the global development of belinostat. In June 2004, we paid a $5.0 million perpetual license fee to TopoTarget and made a $5.0 million equity investment that was recorded as a convertible loan receivable. In June 2005, we converted this loan into 1,429,687 shares of TopoTarget common stock following TopoTarget’s initial public offering on the Copenhagen Stock Exchange. During September 2007, we sold our investment in TopoTarget for proceeds of $6.3 million and had a realized gain of $1.0 million. Under the terms of the agreement, we paid TopoTarget $7.2 million in development milestones from June 2004 through December 2005. Additionally, we paid TopoTarget $6.5 million for research support from June 2004 through June 2007. The research program under this agreement expired in June 2007.

Under our agreement with TopoTarget we are obligated to pay milestones to TopoTarget for the advancement of belinostat through clinical trials and regulatory approval. In addition, TopoTarget is entitled to receive royalties from us based on sales of belinostat outside of Europe and we are entitled to receive reciprocal royalties from TopoTarget based on sales of belinostat in Europe once commercialized. TopoTarget has the option to fund a portion of the global development of belinostat in exchange for higher royalties. We are currently evaluating belinostat in a number of clinical trials as a potential treatment of cancer both as a single agent and in combination with other anti-cancer therapies. In addition, we have an option to select additional HDAC compounds from TopoTarget for clinical development in oncology and other indications for a fee payable to TopoTarget.

Under the terms of the agreement between TopoTarget and us, we received 50% of the initial payment received by TopoTarget under a licensing agreement between TopoTarget and an unrelated third party for a preclinical HDAC compound. In January 2008, TopoTarget was informed by the third party that it will be ceasing development of this preclinical compound in 2008.

 

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Table of Contents

Seattle Genetics

In June 2004, we announced the licensing of Seattle Genetics’ proprietary ADC technology for use with up to two of our fully-human monoclonal antibodies. We paid an upfront fee of $2.0 million for access to the ADC technology for use with CR011-vcMMAE, our first fully-human monoclonal antibody program to utilize this technology which we announced in October 2004. We announced in July 2006 that an IND was filed with the FDA for CR011-vcMMAE and patient enrollment was initiated in a Phase I clinical trial.

We are responsible for research, product development, manufacturing and commercialization under this collaboration. We also pay maintenance and material supply fees as well as research support payments for ongoing assistance provided by Seattle Genetics in developing ADC products. Under the agreement, we are obligated to pay milestones to Seattle Genetics for the advancement of CR011-vcMMAE through clinical trials and regulatory approval. In addition, we are obligated to pay royalties to Seattle Genetics based upon Net Sales of CR011-vcMMAE once commercialized. We may terminate any license under the agreement by providing not less than 90 days prior written notice to Seattle Genetics

Competition

We are subject to significant competition in the development and commercialization of new drugs from organizations that are pursuing strategies, approaches, technologies and products that are similar to our own. Many of the organizations competing with us have greater capital resources, research and development staffs, facilities, and marketing capabilities. We face competition from a number of biotechnology and pharmaceutical companies with products in preclinical development, clinical trials, or approved for conditions identical or similar to the ones we are pursuing.

We are aware of specific companies that are developing HDAC inhibitors for use in the treatment of cancer that may be competitive with ours. With respect to our HDAC inhibitor, belinostat, Merck & Co., Inc. recently received FDA approval to market Zolinza, or vorinostat, the first HDAC inhibitor approved for use in the U.S., for the treatment of cutaneous T-cell lymphoma. Bayer Schering Pharma AG, Gloucester Pharmaceuticals, Inc., Methylgene, Inc., and Novartis Pharma AG are also currently evaluating HDAC inhibitors in clinical trials for the treatment of cancers, and in combinations with other chemotherapies, that are similar to approaches and indications we are pursuing. In addition, many other pharmaceutical and biotechnology companies are engaged in research and development for the treatment of cancer from which we may face intense competition. We expect belinostat to compete on the basis of efficacy, routes of administration, and potentially safety and economic value compared to drugs used in current practice or currently being developed.

Intellectual Property

Our business and competitive position depends in part on our ability to protect our gene sequences, the proteins they encode, fully-human monoclonal antibodies raised against them, small molecules, other products, information systems and proprietary databases, software and other methods and technology. We have filed, and continue to file, patent applications that seek to protect commercially significant aspects of our product candidates. As of the date of this report we had been issued approximately 115 patents worldwide including 88 issued US patents.

CuraGen® and our other trademarks mentioned in this report are the property of CuraGen Corporation. All other trademarks or trade names referred to herein are the property of their respective owners.

Government Regulation and Product Approval

Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacturing, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as those we are developing.

 

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United States Government Regulation

In the United States, the information that must be submitted to the FDA in order to obtain approval to market a new drug varies depending on whether the drug is a new product whose safety and effectiveness has not previously been demonstrated in humans or a drug whose active ingredient(s) and certain other properties are the same as those of a previously approved drug. A new drug will typically follow the new drug application, or NDA, route and a new biologic will typically follow the biologic license application, or BLA, route.

NDA and BLA Approval Processes

In the United States, the FDA regulates drugs and biologics under the Federal Food, Drug and Cosmetic Act, or FFDCA, and in the case of biologics, also under the Public Health Service Act, and the FDA’s implementing regulations.

The process required by the FDA before a drug or biologic may be marketed in the United States generally involves the following:

 

   

completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices;

 

   

submission of an IND which must become effective before human clinical trials may begin;

 

   

performance of adequate and well-controlled human clinical trials according to Good Clinical Practices, or GCPs, to establish the safety and efficacy of the proposed drug for its intended use;

 

   

submission to the FDA of an NDA or BLA;

 

   

satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity or to meet standards designed to ensure the biologic’s continued safety, purity and potency; and

 

   

FDA review and approval of the NDA or BLA.

The results of product development, preclinical studies and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, results of chemical studies and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product. The FDA reviews all NDAs and BLAs submitted before it accepts them for filing. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. Before approving an NDA or BLA, the FDA will inspect the facility or facilities where the product is manufactured.

Expedited review and approval

The FDA has various programs, including fast track, priority review, and accelerated approval, that are intended to expedite or simplify the process for reviewing drugs, and/or provide for approval on the basis of surrogate endpoints. Generally, drugs that may be eligible for these programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs, and those that offer meaningful benefits over existing treatments, however, these programs do not affect the standards for approval. Fast track

 

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designation applies to the combination of the product and the specific indication for which it is being studied. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials.

Orphan drug

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for seven years.

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.

The Clinical Trial Processes

We currently have two products, belinostat and CR011-vcMMAE, in various stages of clinical trial development. All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCPs regulations. Human clinical trials are typically conducted in three sequential phases that may overlap or be combined and are as follows:

 

   

Phase I: The drug candidate is initially introduced into healthy human volunteer subjects or patients with the disease. These studies are designed to determine the safety and side effects associated with increasing dosages, absorption, metabolism, distribution and excretion, pharmacologic and mechanism of action of the drug candidate in humans, and, if possible, to gain early evidence of effectiveness. Sufficient information about a drug candidate’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies;

 

   

Phase II: Involves clinical studies conducted to evaluate the effectiveness of the drug candidate for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug candidate. These studies are typically closely monitored and conducted in a relatively small number of patients, usually involving no more than several hundred patients; and

 

   

Phase III: Clinical trials are performed after preliminary evidence suggesting effectiveness of the drug candidate has been obtained, and are intended to generate additional information about the drug candidate’s effectiveness and safety that is required to evaluate the overall benefit-risk relationship of the drug candidate and to provide an adequate basis for physician labeling. The studies may include anywhere from several hundred to several thousand subjects.

Concurrent with clinical trials, companies usually complete additional animal studies. Companies must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and the manufacturer must develop methods for testing the quality, purity and potency of the final drugs.

 

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Foreign Regulation

In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval.

Under European Union regulatory systems, we may submit marketing authorization applications either under a centralized or decentralized procedure. The centralized procedure, which is compulsory for medicines produced by biotechnology and optional for those which are highly innovative, provides for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides for mutual recognition of national approval decisions. Under the decentralized procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessments report each member state must decide whether to recognize approval. If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states. As in the United States, we may apply for designation of our products as orphan drug for the treatment of a specific indication in the European Union before the application for marketing authorization is made. Orphan drugs in Europe enjoy economic and marketing benefits, including a 10-year market exclusivity period for the approved indication, but not for the same drug, unless another applicant can show that its product is safer, more effective or otherwise clinically superior to the orphan-designated product.

Corporate Restructuring

During June and September 2007, we underwent corporate restructurings to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development, resulting in full year 2007 restructuring charges of $11.3 million. This amount includes an asset impairment charge of $6.3 million associated with the closure of our pilot manufacturing plant on July 27, 2007. In addition, we also announced a reduction in workforce of approximately 55 employees, primarily composed of preclinical and manufacturing researchers, and additional support staff from within the organization. The restructuring actions have been substantially completed at December 31, 2007, although payments will continue into 2008.

Completion of 454 Sale

In May 2007, we completed the sale of our interest in 454 Life Sciences Corporation, a Delaware corporation and our majority-owned subsidiary, or 454, to Roche Diagnostics Operations, Inc., or RDO. The sale was accomplished pursuant to an Agreement and Plan of Merger dated March 28, 2007 by and among Roche Holdings, Inc., 454 and 13 Acquisitions, or the Merger Agreement. Roche Holdings, Inc. subsequently assigned its rights and obligations under the Merger Agreement to RDO, an indirect wholly-owned subsidiary of Roche Holdings, Inc., prior to the closing of the Merger. Roche Holdings, Inc. and RDO are affiliates of F. Hoffman-La Roche Ltd.

The purchase price paid for 454 by RDO was $152.0 million in cash, of which RDO paid $140.0 million in cash and $12.0 million of which was received from the exercise of 454 stock options following the signing of the Merger Agreement. We received $68 million in cash proceeds at closing, and we retain an interest of $14 million in escrowed proceeds, which become distributable to us on August 25, 2008.

In July 2007, an adjustment to the purchase price was made based on the closing balance sheet of 454. This purchase price adjustment resulted in us receiving an additional $0.6 million, which is included in the calculation of the gain on sale of subsidiary on the accompanying consolidated statement of operations for the year ended December 31, 2007.

 

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Our portion of the purchase price for 454 after transaction costs, including the net working capital and net debt adjustment and the amount expected from the escrow, was $82.0 million.

Employees

As of December 31, 2007, we had an aggregate of 33 full and part-time employees. Our employees include scientists, physicians, accountants and lawyers. We believe that we maintain good relationships with our employees. We believe that our future success will depend in large part on our ability to attract and retain experienced and skilled employees.

 

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Item 1A. Risk Factors

Statements contained or incorporated by reference in this Annual Report on Form 10-K that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements regarding future events and our future results are based on current expectations, estimates, forecasts, and projections and the beliefs and assumptions of our management including, without limitation, our expectations regarding results of operations, selling, general and administrative expenses, research and development expenses, the sufficiency of our cash for future operations, and the success of our preclinical, clinical and development programs. Forward-looking statements may be identified by the use of forward-looking terminology such as “may,” “could,” “will,” “expect,” “estimate,” “anticipate,” “continue,” or similar terms, variations of such terms or the negative of those terms.

We cannot assure investors that our assumptions and expectations will prove to have been correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. Such factors that could cause or contribute to such differences include those factors discussed below. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. If any of the following risks actually occur, our business, financial condition, results of operations or liquidity would likely suffer.

Risks Related to Our Business

We have a history of operating losses and expect to incur operating losses in the future. We do not expect to have a meaningful source of recurring revenue in the near future.

We have incurred losses since inception, principally as a result of research and development and general and administrative expenses in support of our operations. We experienced net income of $25.4 million in 2007 principally resulting from the sale of 454, net losses of $59.8 million and $73.2 million in 2006 and 2005, respectively, and as of December 31, 2007 had an accumulated deficit of $487.6 million. We anticipate incurring additional losses as we focus our resources on advancing our most promising drug candidates.

We can not ensure that our existing cash and investment balances will be sufficient to meet our requirements for the future.

We believe that our existing cash and investment balances and other sources of liquidity, will be sufficient to meet our requirements into 2011. We consider our operating expenditures to be crucial to our future success, and by continuing to make strategic investments in our clinical drug pipeline, we believe that we are building substantial value for our stockholders. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors. These factors include: the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our products; in-licensing and out-licensing of pharmaceutical products; and costs incurred in enforcing and defending our patent claims and other intellectual property rights.

While we will continue to explore alternative sources for financing our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our stockholders to lose all or a substantial portion of their investment.

 

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Our drug candidates are still in development and remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our drug candidates, we will not be successful.

To date, we have not marketed, distributed or sold any drug candidates. The success of our business depends primarily upon our ability to develop and commercialize our drug candidates successfully. Our most advanced drug candidates are belinostat, which is in multiple Phase I and Phase II clinical trials, and CR011-vcMMAE, which is currently in a Phase I/II clinical trial. Further development of our other preclinical candidates will be limited in the foreseeable future due to our decision to focus our resources on the development of our clinical development stage oncology therapeutics. Our drug candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy testing and obtain regulatory approval of our drug candidates. Despite our efforts, our drug candidates may not:

 

   

offer therapeutic or other improvement over existing comparable drugs;

 

   

be proven safe and effective in clinical trials;

 

   

meet applicable regulatory standards;

 

   

be capable of being produced in commercial quantities at acceptable costs; or

 

   

be successfully commercialized.

Positive results in preclinical studies of a drug candidate may not be predictive of similar results in humans during clinical trials, and promising results from early clinical trials of a drug candidate may not be replicated in later clinical trials. For example, in the fourth quarter of 2007, we decided to discontinue the development of velafermin after reviewing and evaluating the results of Phase II clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late stage clinical trials even after achieving promising results in early stage development. Accordingly, the results from the completed preclinical studies and clinical trials and ongoing clinical trials for belinostat, CR011-vcMMAE and our other drug candidates may not be predictive of the safety, efficacy or dosing results we may obtain in later stage trials. We do not expect any of our drug candidates to be commercially available for at least several years.

We may not be able to execute our business strategy if we are unable to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of our drug candidates. If we are unsuccessful in forming or maintaining these alliances on favorable terms, our business may not succeed.

We have entered into collaboration arrangements with several companies for the research, development and commercialization of our drug candidates, and we may enter into additional collaborative arrangements in the future. For example, we may enter into alliances with major biotechnology or pharmaceutical companies to jointly develop specific drug candidates and to jointly commercialize them if they are approved. We may not be successful in entering into any such alliances on favorable terms. Even if we do succeed in securing such alliances, we may not be able to maintain them if, for example, development or approval of a drug candidate is delayed or sales of an approved drug are disappointing. Furthermore, any delay in entering into collaboration agreements could delay the development and commercialization of our drug candidates and reduce their competitiveness even if they reach the market. Any such delay related to our collaborations could adversely affect our business.

We may also depend on our alliances with other companies to provide substantial additional funding for development and potential commercialization of our drug candidates. We may not be able to obtain funding on favorable terms from these alliances, and if we are not successful in doing so, we may not have sufficient funds to develop a particular drug candidate internally, or to bring drug candidates to market. Failure to bring our drug candidates to market will prevent us from generating sales revenues, and this may substantially harm our business.

 

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We rely significantly on our collaborative partners to gain access to specified technologies and our business could be harmed if we are unable to maintain strategic alliances.

As part of our business strategy, we have strategic research and development alliances with companies to gain access to specific technologies. These alliances with other pharmaceutical and biotechnology companies may provide us with access to unique technologies, access to capital, near-term revenues, milestone and/or royalty payments, and potential profit sharing arrangements. In return, we provide access to unique technologies, expertise in genomics, and information on the molecular basis of disease, drug targets, and drug candidates. We currently have strategic alliances with Amgen Fremont, TopoTarget, and Seattle Genetics, in addition to numerous smaller agreements to facilitate these efforts. In these strategic alliances, either party can terminate the agreement at any time the alliance permits them to or if either party materially breaches the contract. We may not be able to maintain or expand existing alliances or establish any additional alliances. If any of our existing collaborators were to breach or terminate their agreements with us or otherwise fail to conduct activities successfully and in a timely manner, the preclinical or clinical development or commercialization of product candidates or research programs may be delayed or terminated, which may materially and adversely affect our business, financial condition, and results of operations.

We rely on third parties to conduct our clinical trials and provide other services, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such services.

We do not have the ability to independently conduct some preclinical studies and the clinical trials for our drug candidates, and we rely on third parties such as contract laboratories, contract research organizations, medical institutions and clinical investigators to design and conduct these studies and our clinical trials. Our reliance on these third parties reduces our control over these activities. Accordingly, these third-party contractors may not complete activities on schedule, or may not conduct the studies of our clinical trials in accordance with regulatory requirements of our trial design. To date, we believe our contract research organizations and other similar entities with which we are working have performed well. However, if these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue these activities, it may result in delays. Accordingly, our efforts to obtain regulatory approvals for and commercialize our drug candidates may be delayed.

In addition, our ability to bring our future products to market depends on the quality and integrity of the data we present to regulatory authorities in order to obtain marketing authorizations. We cannot guarantee the authenticity or accuracy of data compiled by third parties, nor can we be certain that such data has not been fraudulently generated. The failure of these third parties to carry out their obligations would materially adversely affect our ability to develop and market new products and implement our strategies.

We currently depend on third-party manufacturers to produce our clinical drug supplies and intend to rely upon third-party manufacturers to produce commercial supplies of any approved drug candidates. If in the future we manufacture any of our drug candidates, we will be required to incur significant costs and devote significant efforts to establish and maintain these capabilities.

We have relied upon third parties to produce material for clinical testing purposes and intend to continue to do so in the future. Although we believe that we will not have any material supply issues, we cannot be certain that we will be able to obtain long-term supplies of those materials on acceptable terms, if at all. We also expect to rely upon third parties to produce materials required for the commercial production of our drug candidates if we succeed in obtaining necessary regulatory approvals. If we are unable to arrange for third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drug candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of a manufacturing agreement by the third party

 

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because of factors beyond our control and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us. In addition, the FDA and other regulatory authorities require that our drug candidates be manufactured according to current Good Manufacturing Practices, or cGMP, regulations. Any failure by us or our third-party manufacturers to comply with cGMP and/or our failure to scale up our manufacturing processes could lead to a delay in, or failure to obtain, regulatory approval of any of our drug candidates. In addition, such failure could be the basis for action by the FDA to withdraw approvals for drug candidates previously granted to us and for other regulatory action.

We currently rely on a single manufacturer for the clinical supplies of our antibody, and ADC drug candidates and do not currently have relationships for redundant supply or a second source for any of these drug candidates. To date, our third-party manufacturers have met our manufacturing requirements, but we cannot assure that they will continue to do so. Any performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval of our drug candidates or commercialization of any approved products. If for some reason our current contract manufacturers cannot perform as agreed, we may be required to replace them. Although we believe there are a number of potential replacements as our manufacturing processes are not manufacturer specific, we may incur added costs and delays in identifying and qualifying any such replacements. Furthermore, although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a drug candidate to complete the trial, any significant delay in the supply of a drug candidate for an ongoing trial due to the need to replace a third-party manufacturer could delay completion of the trial.

We may in the future elect to manufacture certain of our drug candidates in our own manufacturing facilities. If we do so, we will require substantial additional funds and need to recruit qualified personnel in order to build or lease and operate any manufacturing facilities.

Because we have limited experience in developing, commercializing and marketing products, we may be unsuccessful in our efforts to do so.

Our products in development will require significant research and development and preclinical and clinical testing prior to our submitting any regulatory application for their commercial use. These activities, even if undertaken without the collaboration of others, will require us to expend significant funds and will be subject to the risks of failure inherent in the development of pharmaceutical products. We have limited experience conducting clinical trials. Even if we complete such studies, our ability to commercialize products will depend on our ability to:

 

   

obtain and maintain necessary intellectual property rights to our products;

 

   

enter into arrangements with third parties to manufacture our products on our behalf; and

 

   

deploy sales and marketing resources effectively or enter into arrangements with third parties to provide these services.

As a result of these possibilities, we may not be able to develop any commercially viable products. In addition, should we choose to develop pharmaceutical products internally, we will have to make significant investments in pharmaceutical product development, marketing, sales, and regulatory compliance resources and we will have to establish or contract for the manufacture of products under the FDA cGMPs. Any potential products developed by our licensees will be subject to the same risks.

We do not currently have any marketed products. If we develop products that can be marketed, we intend to market the products either independently or together with collaborators or strategic partners. If we decide to market any products independently, we will incur significant additional expenditures and commit significant additional management resources to establish a sales force. For any products that we market together with partners, we will rely, in whole or in part, on the marketing capabilities of those parties. We may also contract with other third parties to market certain of our products. Ultimately, we and our partners may not be successful in marketing our products.

 

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If clinical trials for our drug candidates are prolonged or delayed, we may be unable to commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any product revenue.

We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from our completed or ongoing clinical trials. Any of the following could delay the clinical development of our drug candidates:

 

   

ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

 

   

delays in receiving or the inability to obtain required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;

 

   

delays in enrolling volunteers and patients into clinical trials;

 

   

a lower than anticipated retention rate of volunteers and patients in clinical trials;

 

   

the need to repeat clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

 

   

inadequate supply or deficient quality of drug candidate materials or other materials necessary for the conduct of our clinical trials;

 

   

unfavorable FDA inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

 

   

serious and unexpected drug-related side effects experienced by participants in our clinical trials; or

 

   

the placement by the FDA of a clinical hold on a trial.

Our ability to enroll patients in our clinical trials in sufficient numbers and on a timely basis will be subject to a number of factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial. Delays in patient enrollment may result in increased costs and longer development times. In addition, subjects may withdraw from our clinical trials, and thereby impair the validity or statistical significance of the trials.

We, the FDA or other applicable regulatory authorities may suspend clinical trials of a drug candidate at any time if we or they believe the subjects or patients participating in such clinical trials are being exposed to unacceptable health risks or for other reasons.

We cannot predict whether any of our drug candidates will encounter problems during clinical trials which will cause us or regulatory authorities to delay or suspend these trials, or which will delay the analysis of data from these trials. In addition, it is impossible to predict whether legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. If we experience any such problems, we may not have the financial resources to continue development of the drug candidate that is affected or the development of any of our other drug candidates.

If a collaborative partner terminates or fails to perform its obligations under agreements with us, the development and commercialization of our drug candidates could be delayed or terminated.

If any current or future collaborative partner does not devote sufficient time and resources to collaboration arrangements with us, we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected. In addition, if any existing or future collaboration partner were to breach or terminate its arrangements with us, the development and commercialization of the affected drug candidate could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue development and commercialization of the drug candidate on our own.

 

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Much of the potential revenue from our existing and future collaborations will consist of contingent payments, such as payments for achieving development milestones and royalties payable on sales of drugs developed using our technologies. The milestone and royalty revenues that we may receive under these collaborations will depend upon our collaborator’s ability to successfully develop, introduce, market and sell new products. In addition, our collaborators may decide to enter into arrangements with third parties to commercialize products developed under our existing or future collaborations using our technologies, which could reduce the milestone and royalty revenue that we may receive, if any. In many cases we will not be involved in these processes and accordingly will depend entirely on our collaborators. Our collaboration partners may fail to develop or effectively commercialize products using our products or technologies because they:

 

   

decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;

 

   

do not have sufficient resources necessary to carry the drug candidate through clinical development, regulatory approval and commercialization;

 

   

decide to pursue a competitive drug candidate developed outside of the collaboration; or

 

   

cannot obtain the necessary regulatory approvals.

If our collaboration partners fail to develop or effectively commercialize drug candidates or drugs for any of these reasons, we may not be able to replace the collaboration partner with another partner to develop and commercialize a drug candidate or drugs under the terms of the collaboration. We may also be unable to obtain a license from such collaboration partner on terms acceptable to us, or at all.

Because neither we nor any of our collaborative partners have received marketing approval for any product resulting from our research and development efforts, and may never be able to obtain any such approval, we may not be able to generate any product revenue.

All of the products being developed by our collaborative partners will require additional research and development, extensive preclinical studies and clinical trials, and regulatory approval prior to any commercial sales. In some cases, the length of time that it takes for our collaborative partners to achieve various regulatory approval milestones may affect the payments that we are eligible to receive under our collaboration agreements. We and our collaborative partners may need to address a number of technical challenges successfully in order to complete development of our drug candidates. Moreover, these drug candidates may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities, or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.

If we are unable to obtain U.S. and/or foreign regulatory approval, we will be unable to commercialize our drug candidates.

Our drug candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required in the United States and in many foreign jurisdictions prior to the commercial sale of our drug candidates. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. It is possible that none of the drug candidates we are developing will obtain marketing approval. In connection with the clinical trials for belinostat, CR011-vcMMAE and any other drug candidate we may seek to develop in the future, we face risks that:

 

   

the drug candidate may not prove to be efficacious;

 

   

the drug may not prove to be safe;

 

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the results may not confirm the positive results from earlier preclinical studies or clinical trials; and

 

   

the results may not meet the level of statistical significance required by the FDA or other regulatory authorities.

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA. The time required to complete clinical trials and for the FDA and other countries’ regulatory review processes is uncertain and typically takes many years. Our analysis of data obtained from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unanticipated delays or increased costs due to government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.

Any delay in obtaining, or failure to obtain, required approvals could materially adversely affect our ability to generate revenues from the particular drug candidate. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product. These limitations may limit the size of the market for the product. We are also subject to numerous foreign regulatory requirements governing the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval procedures than those required by the FDA and may impose additional testing requirements for our drug candidates.

Even if we obtain regulatory approvals, our drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals, and our business would be seriously harmed.

Even if we receive regulatory approval of any drugs we may develop, we will be subject to continuing regulatory review, including the review of clinical results which are reported after our drug candidates become commercially available approved drugs. Since drugs are more widely used by patients once approval has been obtained, side effects and other problems may be observed after approval that were not seen or anticipated during pre-approval clinical trials. In addition, the manufacturer, and the manufacturing facilities we use to make any of our drug candidates, will also be subject to periodic review and inspection by the FDA. The subsequent discovery of previously unknown problems with the drug, manufacturer or facility may result in restrictions on the drug, manufacturer or facility, including withdrawal of the drug from the market. If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and criminal prosecutions.

Our business has a substantial risk of product liability claims. If we are unable to obtain appropriate levels of insurance, a product liability claim could adversely affect our business.

Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and sales and marketing of human therapeutic products. Although we do not currently commercialize any products, claims could be made against us based on the use of our drug candidates in clinical trials. We currently have clinical trial insurance and will seek to obtain product liability insurance prior to the sales and marketing of any of our drug candidates. However, our insurance may not provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain current amounts of insurance coverage or obtain additional or sufficient insurance at a reasonable cost to protect against losses that could have a material adverse effect on us. If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as uncovered damages awards resulting from a claim brought successfully against us. Furthermore, whether or not we are ultimately successful in defending any such claims, we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result.

 

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If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may not generate product revenue.

We have no commercial products and we do not currently have an organization for the sales and marketing of pharmaceutical products. In order to successfully commercialize any drugs that may be approved in the future by the FDA or comparable foreign regulatory authorities, we must build our sales and marketing capabilities or make arrangements with third parties to perform these services. There are risks involved with establishing our own sales and marketing capabilities, as well as entering into arrangements with third parties to perform these services. For example, developing a sales force is expensive and time consuming and could delay any product launch. In addition, to the extent that we enter into arrangements with third parties to perform sales, marketing and distribution services, we will have less control over sales of our products, and our future revenues would depend heavily on the success of the efforts of these third parties. If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable.

If physicians, patients and third-party payors do not accept our future drugs, we may be unable to generate significant revenue, if any.

Even if belinostat, CR011-vcMMAE or any other drug candidates we may develop or acquire in the future obtain regulatory approval, they may not gain market acceptance among physicians, patients and health care payors. Physicians may elect not to recommend these drugs for a variety of reasons including:

 

   

timing of market introduction of competitive drugs;

 

   

lower demonstrated clinical safety and efficacy compared to other drugs;

 

   

lack of cost-effectiveness;

 

   

lack of availability of reimbursement from third-party payors;

 

   

convenience and ease of administration;

 

   

prevalence and severity of adverse side effects;

 

   

other potential advantages of alternative treatment methods; and

 

   

ineffective marketing and distribution support.

If our approved drugs fail to achieve market acceptance, we would not be able to generate sufficient revenue from product sales to maintain or grow our business.

If third-party payors do not adequately reimburse customers for any of our product candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.

Our revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third-party payors, both in the United States and in foreign markets. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

   

a covered benefit under its health plan;

 

   

safe, effective and medically necessary;

 

   

appropriate for the specific patient;

 

   

cost-effective; and

 

   

neither experimental nor investigational.

 

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Obtaining reimbursement approval for a product from each government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable authority. Moreover, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used to calculate these rates. Net prices for products may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.

There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect payments for our products. The Centers for Medicare and Medicaid Services, or CMS, frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party payors may have sufficient market power to demand significant price reductions. Due in part to actions by third-party payors, the health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products.

Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payors for our products could have a material adverse effect on our operating results and our overall financial condition.

We depend on attracting and retaining key employees.

We are highly dependent on the principal members of our senior management and scientific staff. Our future success will depend in part on the continued services of our key management and scientific personnel. The loss of services of any of these personnel could materially adversely affect our business, financial condition, and results of operations. We have entered into employment agreements with all of the principal members of our senior management team. Our future success will also depend in part on our ability to attract, hire, and retain additional personnel. There is intense competition for qualified personnel and there can be no assurance that we will be able to continue to attract and retain such personnel. Failure to attract and retain key personnel could materially, adversely affect our business, financial condition, and results of operations.

We depend on academic collaborators, consultants, and scientific advisors.

We have relationships with collaborators, consultants, and scientific advisors at academic and other institutions that conduct research or provide consulting services at our request. These collaborators, consultants, and scientific advisors are not our employees. Substantially all of our collaborators, consultants, and scientific advisors are employed by employers other than us and may have commitments to, or collaboration, consulting, or advisory contracts with, other entities that may limit their availability to us. As a result, we have limited control over their activities and, except as otherwise required by our collaboration, consulting agreements, and advisory agreements, can expect only limited amounts of their time to be dedicated to our activities. Our ability to explore and validate biological activity of therapeutic candidates and commercialize products based on these discoveries may depend, in part, on continued collaborations with researchers at academic and other institutions. We may not be able to negotiate additional acceptable collaborations with collaborators, consultants, or scientific advisors at academic and other institutions.

 

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Our academic collaborators, consultants, and scientific advisors may have relationships with other commercial entities, some of which could compete with us. Our academic collaborators, consultants and scientific advisors sign agreements which provide for confidentiality of our proprietary information and of the results of studies. We may not be able to maintain the confidentiality of our technology and other confidential information in connection with every academic collaboration, consulting, or advisory arrangement, and any unauthorized dissemination of our confidential information could materially adversely affect our business, financial condition, and results of operations. Further, any such collaborator, consultant or advisor may enter into an employment agreement or consulting arrangement with one of our competitors.

Competition in our field is intense and likely to increase.

We are subject to significant competition in the development and commercialization of new drugs from organizations that are pursuing strategies, approaches, technologies and products that are similar to our own. Many of the organizations competing with us have greater capital resources, research and development staffs and facilities and marketing capabilities. We face competition from a number of biotechnology and pharmaceutical companies with products in preclinical development, clinical trials, or approved for conditions identical or similar to the ones we are pursuing.

We are aware of specific companies that are developing HDAC inhibitors for use in the treatment of cancer that may be competitive with ours. With respect to our HDAC inhibitor, belinostat, Merck & Co., Inc. recently received FDA approval to market Zolinza, or vorinostat, the first HDAC inhibitor approved for use in the U.S., for the treatment of cutaneous T-cell lymphoma. Bayer Schering Pharma AG, Gloucester Pharmaceuticals, Inc., Methylgene, Inc., and Novartis Pharma AG are also currently evaluating HDAC inhibitors in clinical trials for the treatment of cancers, and in combinations with other chemotherapies, that are similar to approaches and indications we are pursuing. In addition, many other pharmaceutical and biotechnology companies are engaged in research and development for the treatment of cancer from which we may face intense competition. We expect belinostat to compete on the basis of efficacy, routes of administration, and potentially safety and economic value compared to drugs used in current practice or currently being developed.

If we do not obtain adequate intellectual property protection, we may not be able to prevent our competitors from commercializing our discoveries.

Our business and competitive position depends on our ability to protect our products and processes, including obtaining patent protection on genes and proteins for which we or our collaborators discover utility, and on products, methods and services based on such discoveries.

The patent positions of pharmaceutical, biopharmaceutical, and biotechnology companies, including us, are generally uncertain and involve complex legal and factual questions. The law relating to the scope of patent claims in the technology fields in which we operate is evolving, and the degree of future protection for our proprietary rights is uncertain. Furthermore, even if patents are issued to us, there can be no assurance that others will not develop alternative technologies or design around the patented technologies developed by us. Therefore, our patent applications may not protect our products, processes, and technologies for at least the following reasons:

 

   

there is no guarantee that any of our pending patent applications will result in additional issued patents;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will provide a basis for commercially viable products;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will provide us with any competitive advantages;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will not be challenged or circumvented or invalidated by third parties; and

 

   

there is no guarantee that any patents issued to others will not have an adverse effect on our ability to do business.

 

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The issuance of a patent is not conclusive as to its validity or enforceability, nor does it provide the patent holder with freedom to operate without infringing the patent rights of others. A patent could be challenged by litigation and, if the outcome of such litigation were adverse to the patent holder, competitors could be free to use the subject matter covered by the patent. The invalidation of key patents owned by or licensed to us or the non-approval of pending patent applications could increase competition and materially adversely affect our business, financial condition, and results of operations.

Litigation, which could result in substantial cost to us, also may be necessary to enforce our patent and proprietary rights and/or to determine the scope and validity of others’ proprietary rights. We may participate in interference proceedings that may in the future be declared by the USPTO to determine priority of invention, which could result in substantial cost to us. The outcome of any such litigation or interference proceeding might not be favorable to us, and we might not be able to obtain licenses to technology that we require or, even if obtainable, such technology may not be available at a reasonable cost.

If we infringe on the intellectual property rights of others, we may be required to obtain a license, pay damages, and/or cease the commercialization of our technology.

We believe that there may be significant litigation in the industry regarding patent and other intellectual property rights. It is possible that the commercialization of our technology could infringe the patents or other intellectual property rights of others. In addition, others may have filed, and in the future are likely to file, patent applications covering genes or gene products or antibodies against the gene products that are similar or identical to our products. Any such patent applications may have priority over our patent applications, and may result in the issuance of patents to others that could be infringed by our products or processes.

A number of competitors are producing proteins from genes and claiming both the proteins as potential therapeutics as well as the antibodies against these proteins. In many cases, generic antibody claims are being issued by the USPTO even though competitors have not actually made antibodies against the protein of interest, or do not have cellular, animal, or human data to support the use of these antibodies as therapeutics. These claims to proteins as therapeutics, to all antibodies against a protein, and to methods of use in broad human indications are being filed at a rapid rate, and patents including such claims have issued and may continue to issue. Such patents may prevent us from commercializing some products or processes or, if licenses under the patents are made available, may make the royalty burden on these products and processes so high as to prevent commercial success.

In addition, we have sought and intend to continue to seek patent protection for novel uses for genes and proteins and therapeutic antibodies that may have been patented by third parties. In such cases, we would need a license from the holder of the patent with respect to such gene or protein in order to make, use, or sell such gene or protein for such use. We may not be able to acquire such licenses on commercially reasonable terms, if at all.

Any legal action against us or our collaborators for patent infringement relating to our products and processes could, in addition to subjecting us to potential liability for damages, require us or our collaborators to obtain a license in order to continue to manufacture or market the affected products and processes, or could enjoin us from continuing to manufacture or market the affected products and processes. There can be no assurance that we or our collaborators would prevail in any such action or that any license required under any such patent would be made available on commercially acceptable terms, if at all. If we become involved in such litigation, it could consume a substantial portion of our managerial and financial resources.

We cannot be certain that our security measures will protect our confidential information and proprietary technologies.

We rely upon trade secret protection for some of our confidential and proprietary information that is not the subject matter for which patent protection is being sought. We have taken security measures to protect our proprietary technologies, processes, information systems, and data and continue to explore ways to enhance such

 

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security. Such measures, however, may not provide adequate protection for our trade secrets or other proprietary information. While we require employees, academic collaborators, consultants, and scientific advisors to enter into confidentiality and/or non-disclosure agreements where appropriate, any of the following could still occur:

 

   

proprietary information could be disclosed;

 

   

others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets, technology, or disclose such information; or

 

   

we may not be able to meaningfully protect our trade secrets.

If the security of our confidential information is breached, our business could be materially adversely affected.

We depend upon our ability to license technologies.

We may have to acquire or license certain components of our technologies or products from third parties. We may not be able to acquire from third parties or develop new technologies, either alone or with others. We may not be able to acquire licenses on commercially reasonable terms, if at all. Failure to license or otherwise acquire necessary technologies could materially adversely affect our business, financial condition, and results of operations.

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

Our research and development efforts involve the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Although we maintain workers’ compensation insurance to cover us for costs we may incur due to injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against potential liabilities. Due to the small amount of hazardous materials that we generate, we do not currently maintain any environmental liability or toxic tort claim insurance coverage to cover pollution conditions or other extraordinary or unanticipated events relating to our use and disposal of hazardous materials. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.

 

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Risks Related to Our Financial Results

We have a large amount of convertible debt and our debt service obligations may prevent us from taking actions that we would otherwise consider to be in our best interests.

As of December 31, 2007, we had total debt of $69.9 million which is due in February 2011; and for the year ended December 31, 2007, we had a deficiency of earnings available to cover fixed charges of $50.1 million. A variety of uncertainties and contingencies will affect our future performance, many of which are beyond our control. We may not generate sufficient cash flow in the future to enable us to meet our anticipated fixed charges, including our debt service requirements. The following table shows, as of December 31, 2007, the remaining aggregate amount of our interest payments due in each of the years listed (in millions):

 

Year

   Aggregate
Interest

2008

   $ 2.8

2009

     2.8

2010

     2.8

2011

     1.4
      

Total

   $ 9.8
      

Our substantial leverage could have significant negative consequences for our future operations, including:

 

   

increasing our vulnerability to general adverse economic and industry conditions;

 

   

limiting our ability to obtain additional financing;

 

   

requiring the dedication of a substantial portion of our expected cash flow to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including working capital and capital expenditures;

 

   

limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; or

 

   

placing us at a possible competitive disadvantage compared to less leveraged competitors and competitors that have better access to capital resources.

We will likely need to raise additional funding, which may not be available on favorable terms, if at all.

We believe that we have sufficient capital to satisfy our funding requirements into 2011. However, our future funding requirements will depend on many factors and we anticipate that we will likely need to raise additional capital to fund our business plan and research and development efforts on a going-forward basis. To the extent that we need to obtain additional funding, the amount of additional capital we would need to raise would depend on many factors, including:

 

   

the number, breadth, and progress of our research, product development, and clinical programs;

 

   

our ability to establish and maintain ongoing and future potential strategic collaborations;

 

   

the progress of our collaborators;

 

   

our costs incurred in enforcing and defending our patent claims and other intellectual property rights;

 

   

the costs and timing of obtaining regulatory approvals for any of our products; and

 

   

the extent to which RDO makes successful claims for indemnification under the Merger Agreement relating to the sale of 454.

 

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We expect that we would raise any additional capital we require through public or private equity offerings, debt financings, or additional collaborations and licensing arrangements. We cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. If we raise additional capital by issuing equity securities, the issuance of such securities would result in ownership dilution to our stockholders. If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish rights to certain of our technologies or product candidates, or to grant licenses on unfavorable terms. The relinquishing of rights or granting of licenses on unfavorable terms could materially adversely affect our business, financial condition, and results of operations. If adequate funds are not available, our business, financial condition, and results of operations would be materially adversely affected. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products. If we require additional capital at a time when investment in biotechnology companies such as ours, or in the marketplace in general, is limited due to the then prevailing market or other conditions, we may not be able to raise such funds at the time that we desire or any time thereafter.

If the proceeds we receive from the sale of our stake in 454 are less than anticipated due to indemnification claims against the escrow account, our liquidity may be impaired, and we may be forced to seek alternative sources of financing sooner than anticipated.

We expect to use the proceeds we receive from the sale of our stake in 454 to make further investments in our clinical drug pipeline; however, as described in Note 13 to our condensed consolidated financial statements included in this Annual Report on Form 10-K, $25 million of the total sale proceeds to 454 stockholders has been placed in an escrow account in order to secure certain indemnification rights of RDO and its affiliates. Our portion of the $25 million escrow fund totals $14.5 million which includes interest. Under the Merger Agreement, Roche is currently entitled to indemnification for damages incurred by RDO, 454 and certain other RDO affiliates upon the occurrence of certain events, including: breaches of representations, warranties or covenants made by 454 in the Merger Agreement; and costs incurred by the indemnified parties in connection with the sale of 454 that were not previously taken into account in determining the price paid by RDO for 454. If RDO makes a successful claim for indemnification due to one or more of these reasons, the amount of the escrow account that is available for distribution to us and other 454 stockholders at the end of the 15-month escrow period will be reduced or eliminated.

Our quarterly operating results have fluctuated greatly and may continue to do so.

Our operating results have fluctuated on a quarterly basis. We expect that losses will continue to fluctuate from quarter to quarter and that these fluctuations may be substantial. Our results of operations are difficult to predict and may fluctuate significantly from period to period, which may cause our stock price to decline and result in losses to investors. Some of the factors that could cause our operating results to fluctuate include:

 

   

the nature, pricing, and timing of products and services provided to our collaborators and customers;

 

   

our ability to compete effectively in our therapeutic development efforts against competitors that have greater financial or other resources or drug candidates that are in further stages of development;

 

   

acquisition, licensing, and other costs related to our operations;

 

   

losses and expenses related to our investments;

 

   

regulatory developments;

 

   

regulatory actions and changes related to the development of drugs;

 

   

changes in intellectual property laws that affect our patent rights;

 

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payments of milestones, license fees, or research payments under the terms of our external alliances and collaborations and our ability to monitor and enforce such payments; and

 

   

the timing of intellectual property licenses that we may enter.

We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. In addition, fluctuations in quarterly results could affect the market price of our common stock in a manner unrelated to our long-term operating performance.

Our debt investments are impacted by the financial viability of the underlying companies or assets.

We have a diversified portfolio of investments, of which 31% of our debt investments at December 31, 2007 were invested in U.S. Treasuries and mortgage backed securities that are sponsored by the U.S. Government. Additionally, we have 28.6% of our investment portfolio in asset backed securities which consist of auto, credit card and equipment loans all with AAA ratings by Moody’s and 11.3% of our investment portfolio in mortgage backed securities which are all sponsored by the US Government. Our fixed-rate debt investments comply with our policy of investing in only investment-grade debt instruments. The ability for the debt to be repaid upon maturity or to have a viable resale market is dependent, in part, on the financial success of the underlying company or assets. Should the underlying company or assets suffer significant financial difficulty, the debt instrument could either be downgraded or, in the worst case, our investment could be worthless. This would result in our losing the cash value of the investment and incurring a charge to our statement of operations.

The market price of our common stock is highly volatile.

The market price of our common stock has fluctuated widely and may continue to do so. For example, during the fiscal year 2007, the closing price of our stock ranged from a high of $4.99 per share to a low of $0.73 per share. Many factors could cause the market price of our common stock to rise and fall. These factors include:

 

   

variations in our quarterly operating results;

 

   

announcements of clinical results, technological innovations, or new products by us or our competitors;

 

   

introduction of new products or new pricing policies by us or our competitors;

 

   

acquisitions or strategic alliances by us or others in our industry;

 

   

announcement by the government or other agencies regarding the economic health of the United States and the rest of the world;

 

   

the hiring or departure of key personnel;

 

   

changes in market valuations of companies within the biotechnology industry; and

 

   

changes in estimates of our performance or recommendations by financial analysts.

Our common stock could be delisted from the NASDAQ Global Market if our stock price continues to trade below $1.00 per share.

On January 28, 2008, we received notification from The NASDAQ Stock Market LLC, or NASDAQ, indicating that we are not in compliance with NASDAQ Marketplace Rule 4450(a)(5), or the Rule, because the closing bid price per share for the our common stock had been below $1.00 per share, or the Minimum Bid Price Requirement, for 30 consecutive business days. In accordance with NASDAQ Marketplace Rule 4450(e)(2), we were provided 180 calendar days, or until July 28, 2008, to regain compliance.

To regain compliance with the Minimum Bid Price Requirement, the closing bid price of our common stock must remain at $1.00 per share or more for a minimum of ten consecutive business days. If we do not regain compliance with the Rule by July 28, 2008, we can apply to list our common stock on the NASDAQ Capital

 

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Market and NASDAQ will determine whether we meet the NASDAQ Capital Market initial listing criteria as set forth in NASDAQ Marketplace Rule 4310(c), except for the Minimum Bid Price Requirement. If we meet the NASDAQ Capital Market initial listing criteria , NASDAQ will notify us that we have been granted an additional 180 calendar days to come into compliance with the Minimum Bid Price Requirement. If we do not meet the initial listing criteria, NASDAQ will provide us with written notification that our common stock will be delisted. At that time we would be permitted to appeal NASDAQ’s determination to delist our common stock to a NASDAQ Listings Qualifications Panel.

We will seek to regain compliance with the Minimum Bid Price Requirement within the 180 day cure period and are considering alternatives to address compliance with the continued listing standards of the NASDAQ Global Market.

Delisting from the NASDAQ Global Market could have an adverse effect on our business and on the trading of our common stock. If a delisting of our common stock from the NASDAQ Stock Market were to occur, our common stock would trade on the OTC Bulletin Board or on the “pink sheets” maintained by the National Quotation Bureau, Inc. Such alternatives are generally considered to be less efficient markets, and our stock price, as well as the liquidity of our common stock, may be adversely impacted as a result.

We have significant leverage as a result of the sale of our debt in 2004.

In February 2004, in connection with the sale of our 4% convertible subordinated notes due 2011, we incurred $100.0 million of indebtedness. In addition, in March 2004, the initial purchasers exercised their option to purchase an additional $10.0 million of 4% convertible subordinated notes due in 2011. During 2007, we repurchased a total of $40.1 million of our 4% convertible subordinated debentures due February 2011, for total consideration of $31.0 million, plus accrued interest of $0.4 million to the date of repurchase. As a result of the remaining indebtedness, our interest payment obligations amount to $2.8 million per year.

The degree to which we are leveraged could adversely affect our ability to obtain further financing for working capital, acquisitions, or other purposes and could make us more vulnerable to industry downturns and competitive pressures. Our ability to meet our debt service obligations will depend upon our future performance, which may be subject to the financial, business, and other factors affecting our operations, many of which are beyond our control.

There are no restrictive covenants in our indentures relating to our ability to incur future indebtedness.

The indentures governing our convertible debt due in 2011 do not contain any financial or operating covenants or restrictions on the payment of dividends, the incurrence of indebtedness, transactions with affiliates, incurrence of liens, or the issuance or repurchase of securities by us or any of our subsidiaries. We may therefore incur additional debt, including secured indebtedness senior to these notes.

Our debt service obligations may adversely affect our cash flow.

A higher level of indebtedness increases the risk that we may default on our debt obligations. We cannot be certain that we will be able to generate sufficient cash flow to pay the interest on our debt or that future working capital, borrowings, or equity financing will be available to pay or refinance such debt. If we are unable to generate sufficient cash flow to pay the interest on our debt, we may have to delay or curtail our research and development programs. The level of our indebtedness among other things, could:

 

   

make it difficult for us to make payments on our notes;

 

   

make it difficult for us to obtain any necessary financing in the future for working capital, capital expenditures, debt service requirements, or other purposes;

 

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limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

   

make us more vulnerable in the event of a downturn in our business.

Our ability to repurchase notes, if required, with cash upon a change in control or fundamental change may be limited.

In certain circumstances involving a change of control or fundamental change, we may be required to repurchase some or all of the notes due February 2011. We cannot be certain that we will have sufficient financial resources at such time or would be able to arrange financing to pay the repurchase price of the notes. Our ability to repurchase the notes in such event may be limited by law, by the indenture, and by such indebtedness and agreements as may be entered into, replaced, supplemented, or amended from time to time.

Securities we issue to fund our operations could cause dilution to our stockholders’ ownership.

We may decide to raise additional funds through a public or private debt or equity financing to fund our operations. If we raise funds by issuing equity securities, the percentage ownership of current stockholders will be reduced, and the new equity securities may have rights with priority over our common stock. We may not be able to obtain sufficient financing on terms that are favorable to us or our existing stockholders, if at all.

Any conversion of our convertible debt into shares of common stock will dilute the ownership interest of our current stockholders. The conversion price of our convertible debt due in February 2011 is approximately $9.69 per share.

We may effect future repurchases of our 4% convertible debentures due in February 2011, which may adversely affect our liquidity.

We may from time to time seek to repurchase or refinance a portion of our outstanding 4% convertible debentures that mature on February 15, 2011. Any repurchases might occur through cash purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions and other factors. The amounts involved in any such transaction, individually or in the aggregate, may be material.

 

Item 1B. Unresolved Staff Comments

Not applicable.

 

Item 2. Properties

We maintain executive, administrative and research offices at our Branford, Connecticut location. At December 31, 2007, we leased a total of approximately 56,000 square feet at that location under a lease that expires in June 2008. We also lease approximately 5,000 square feet of additional space that we are not currently occupying and for which the lease expires in October 2008. We believe that our facilities are adequate for our current operations or that suitable additional leased space after June 2008 will be available as needed.

 

Item 3. Legal Proceedings

We are not currently a party to any material legal proceedings.

 

Item 4. Submission Of Matters To A Vote Of Security Holders

Not applicable.

 

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PART II

 

Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our common stock is traded on the Nasdaq Global Market under the symbol “CRGN”. The following table sets forth, for the periods indicated, the low and high sales prices per share for our common stock, as reported by the Nasdaq Global Market:

 

     2007
     Low    High

Quarter Ended March 31, 2007

   $ 2.95    $ 4.99

Quarter Ended June 30, 2007

     1.82      3.19

Quarter Ended September 30, 2007

     1.08      2.05

Quarter Ended December 31, 2007

     0.73      1.58

 

     2006
     Low    High

Quarter Ended March 31, 2006

   $ 3.02    $ 5.41

Quarter Ended June 30, 2006

     3.03      5.01

Quarter Ended September 30, 2006

     2.73      3.55

Quarter Ended December 31, 2006

     3.40      4.97

On January 28, 2008, we received written notification from The NASDAQ Stock Market LLC, or NASDAQ, advising us that the bid price of our common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per share, or the Minimum Bid Price Requirement, required for continued listing on the NASDAQ Global Market pursuant to NASDAQ Marketplace Rule 4450(a)(5), or the Rule. The Notice has no effect on the listing of our common stock at this time. Pursuant to NASDAQ Marketplace Rule 4450(e)(2), we have been provided an initial period of 180 calendar days, or until July 28, 2008, to regain compliance with the Minimum Bid Price Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of our common stock must remain at $1.00 per share or more for a minimum of ten consecutive business days. If we do not regain compliance with the Rule by July 28, 2008, we can apply to list our common stock on the NASDAQ Capital Market and NASDAQ will determine whether we meet the NASDAQ Capital Market initial listing criteria as set forth in NASDAQ Marketplace Rule 4310(c), except for the Minimum Bid Price Requirement. If we meet the NASDAQ Capital Market initial listing criteria , NASDAQ will notify us that we have been granted an additional 180 calendar days to come into compliance with the Minimum Bid Price Requirement. If we do not regain compliance by July 28, 2008, NASDAQ will provide notice to us that our common stock will be delisted from the NASDAQ Global Market.

Stockholders

As of February 29, 2008, there were approximately 198 stockholders of record of our common stock and, according to our estimates, 5,147 beneficial owners of our common stock.

Dividends

We have never paid cash dividends on our common stock and do not anticipate declaring any cash dividends in the foreseeable future. We currently intend to retain earnings, if any, to finance the development of our business.

Equity Compensation Plan Information

Information relating to compensation plans under which our equity securities are authorized for issuance is set forth under “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders.

 

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Performance Graph

The performance graph compares CuraGen Corporation’s cumulative 5-year total shareholder return on common stock with the cumulative total returns of The NASDAQ Composite Index and The NASDAQ Biotechnology Index (capitalization weighted). The graph tracks the performance of a $100 investment in our common stock and in each of the designated indexes assuming (with the reinvestment of all dividends) for the period 12/31/2002 to 12/31/2007. The stock price performance included in this graph is not necessarily indicative of future stock price performance.

LOGO

 

          Cumulative Total Return
     Base Period
12/31/02
   12/31/03    12/31/04    12/31/05    12/31/06    12/31/07

CuraGen Corporation

   $ 100.00    $ 157.63    $ 153.98    $ 66.24    $ 98.92    $ 19.78

NASDAQ Composite Index

     100.00      149.75      164.64      168.60      187.83      205.22

NASDAQ Biotechnology Index

     100.00      146.95      164.05      185.29      183.09      186.22

 

(1) Graph assumes $100 invested on December 31, 2002 in our common stock, The NASDAQ Composite Index and The NASDAQ Biotechnology Index (capitalization weighted).
(2) Total return assumes reinvestment of dividends.
(3) Year ended December 31.

The information included under the heading “Performance Graph” in Item 5 of this Annual Report on Form 10-K is “furnished” and not “filed” and shall not be deemed to be “soliciting material” or subject to Regulation 14A, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

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Item 6. Selected Consolidated Financial Data

The selected consolidated financial data set forth below are derived from our audited consolidated balance sheets as of December 31, 2007 and 2006 and the related audited consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2007 and notes thereto, which are included elsewhere in this report. The sale of 454 Life Sciences Corporation on May 25, 2007 has been accounted for as a discontinued operation and is presented as such for all periods. The consolidated balance sheet data as of December 31, 2005, 2004 and 2003 and the consolidated statements of operations data for each of the two years in the periods ended December 31, 2004 and 2003 have been derived from our related financial statements which are not included herein. Historical results are not necessarily indicative of future results. See the notes to the consolidated financial statements for an explanation of the method used to determine the number of shares used in computing basic and diluted net loss per common share. The selected consolidated financial data set forth below should be read in conjunction with, and is qualified in its entirety by our audited consolidated financial statements and related notes thereto found at “Item 8. Financial Statements and Supplementary Data” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” which are included elsewhere in this Annual Report on Form 10-K.

 

     Year Ended December 31,  
     2007     2006     2005     2004     2003  
     (In thousands, except per share amounts)  

Consolidated Statement of Operations Data

          

Total revenue

   $ 88     $ 2,298     $ 4,825     $ 4,684     $ 6,918  

Total operating expenses

     59,710       57,657       72,503       80,235       71,292  

Loss from continuing operations

     (49,963 )     (57,165 )     (69,168 )     (79,588 )     (65,151 )

Income (loss) from discontinued operations

     75,361       (2,675 )     (4,076 )     (10,809 )     (9,345 )

Net income (loss)

     25,398       (59,839 )     (73,244 )     (90,397 )     (74,497 )

Basic and diluted loss per share from continuing operations

     (0.89 )     (1.04 )     (1.33 )     (1.59 )     (1.32 )

Basic and diluted income (loss) per share from discontinued operations

     1.34       (0.05 )     (0.08 )     (0.22 )     (0.19 )

Basic and diluted net income (loss) per share

     0.45       (1.09 )     (1.41 )     (1.81 )     (1.51 )

Weighted average number of shares used in computing basic and diluted net income (loss) per share

     55,853       54,896       51,991       49,943       49,335  

 

    December 31,
    2007   2006   2005   2004   2003
    (In thousands)

Consolidated Balance Sheet Data

         

Cash and investments

  $ 100,444   $ 164,393   $ 211,238   $ 320,296   $ 319,444

Restricted cash

    14,533     —       —       —       —  
                             

Total cash and investments and restricted cash

    114,977     164,393     211,238     320,296     319,444
                             

Working capital

    107,844     95,985     205,610     316,516     328,868

Total assets

    119,282     227,294     269,979     366,671     368,742

4% Convertible subordinated notes due 2011

    69,890     110,000     110,000     110,000     —  

6% Convertible subordinated debentures due 2007

    —       66,228     66,228     130,000     150,000
                             

Total convertible subordinated notes and debentures

    69,890     176,228     176,228     240,000     150,000
                             

Total long-term liabilities

    70,975     111,174     176,228     240,000     150,000

Accumulated deficit

    487,574     512,972     453,133     379,889     289,492

Stockholders’ equity

    38,465     8,767     56,484     106,926     197,667

Cash dividends declared per common share

    None     None     None     None     None

 

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Deficiency of Earnings Available to Cover Fixed Charges

The following table sets forth our consolidated deficiency of earnings available to cover fixed charges.

 

     Year Ended December 31,  
     2007     2006     2005     2004     2003  
     (In thousands)  

Deficiency of earnings available to cover fixed
charges (1) (2)

   ($ 50,148 )   ($ 57,540 )   ($ 69,571 )   ($ 80,770 )   ($ 65,580 )

 

(1) Earnings were inadequate to cover fixed charges. We needed additional earnings, as indicated by the deficiency of earnings available to cover fixed charges for each of the periods presented above, to achieve a ratio of earnings to fixed charges of 1.0x.
(2) The deficiency of earnings available to cover fixed charges is computed by subtracting fixed charges from the loss from continuing operations before income tax benefit plus fixed charges. Fixed charges consist of interest expense plus that portion of net rental expense deemed representative of interest.

 

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Our management’s discussion and analysis of our financial condition and results of operations include the identification of certain trends and other statements that may predict or anticipate future business or financial results that are subject to important factors that could cause our actual results to differ materially from those indicated. See Item 1A, “Risk Factors.”

Overview

We are a biopharmaceutical development company dedicated to improving the lives of patients by developing novel therapeutics for the treatment of cancer. We have taken a systematic approach to identifying and validating promising therapeutics and are now focused on developing and advancing these potential drug candidates through clinical development.

We are currently focusing the majority of our human and financial resources on our oncology therapeutics. We also maintain a portfolio of protein, antibody, and small molecule therapeutics, and targets in various stages of development in the area of oncology.

 

   

Belinostat—is a small molecule therapeutic, formerly referred to as PXD101, which inhibits the activity of the enzyme HDAC and is being evaluated for the treatment of solid and hematologic cancers either alone or in combination with other active chemotherapeutic drugs and newer targeted agents. We are actively conducting clinical trials evaluating intravenous and oral belinostat for:

 

Indication

  

Phase

  

Regimen

  

Initiation of Patient
Enrollment

  

Status

T-cell lymphomas

   II    Monotherapy    January 2006    Enrollment ongoing. Updated results anticipated in the first half of 2008.

Ovarian cancer

   II    Combination with paclitaxel and/or carboplatin    November 2006    Enrollment complete. Updated results anticipated in the first half of 2008.

Bladder cancer

   II    Combination with paclitaxel and/or carboplatin    June 2007    Enrollment ongoing.

Solid tumors

   Ib    Combination with
5-fluorouracil (“5-FU”)
   September 2005    Enrollment ongoing.

Soft tissue sarcoma

   I/II    Combination with doxorubicin    May 2007    Enrollment ongoing.

Acute myeloid leukemia

   I/II    Combination with idarubicin    August 2007    Enrollment ongoing.

Advanced solid tumors

   I    Oral belinostat monotherapy    August 2006    Enrollment ongoing.

 

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Under a Clinical Trial Agreement, or CTA, that we signed with the National Cancer Institute, or NCI, the NCI is sponsoring ten clinical trials evaluating intravenous belinostat for the treatment of:

 

Indication

  

Phase

  

Regimen

  

Initiation of Patient

Enrollment

Advanced solid tumors or lymphomas

   Ib    Combination with Velcade®    March 2006

Acute Myelogenous Leukemia

   II    Monotherapy    June 2006

Advanced solid tumors

   Ib    Combination with cis-retinoic acid    June 2006

Mesothelioma

   II    Monotherapy    June 2006

Hepatocellular carcinoma

   I/II    Monotherapy    July 2006

Advanced hematologic malignancies

   I    Combination with azacitidine    August 2006

B-cell lymphomas

   II    Monotherapy    August 2006

Ovarian

   II    Monotherapy    November 2006

Myelodysplastic syndrome

   II    Monotherapy    November 2006

Thymoma / thymic carcinoma

   II    Monotherapy    December 2007

 

   

CR011-vcMMAE—is a fully-human monoclonal antibody resulting from our collaboration with Amgen Fremont and utilizes ADC technology licensed from Seattle Genetics to attach MMAE to yield CR011-vcMMAE. In June 2006, we announced that the IND for CR011-vcMMAE was cleared by the FDA and dosing of patients in a Phase I/II clinical trial had begun. The open-label, multi-center, dose escalation study is evaluating the safety, tolerability and pharmacokinetics of CR011-vcMMAE for patients with unresectable Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy. The first part of the trial has been evaluating cohorts of patients receiving increasing doses of CR011-vcMMAE to assess safety and determine the MTD. The trial has treated 25 patients with doses of up to 1.88 mg/kg CR011-vcMMAE administered intravenously once every three weeks. The dose escalation assessment of CR011-vcMMAE is ongoing with patients treated at doses up to 2.63 mg/kg. After determination of the MTD, up to approximately 32 additional patients are expected to be enrolled and treated at the MTD to further define safety and activity of CR011-vcMMAE in this efficacy portion of the trial;

 

   

Velafermin—is a protein therapeutic we were investigating for the prevention of oral mucositis. We have discontinued the development of this protein after our Phase II dose-confirmatory clinical trial did not meet its primary endpoint. Patients enrolled in this study are being followed for approximately one year post treatment to satisfy protocol-specified safety monitoring. Therefore, the study will not be clinically complete until approximately September 2008. No new obligations will be initiated with this program.

In addition, we have several potential protein, antibody, and small molecule therapeutics that have been evaluated in animal studies. We will continue to evaluate strategic opportunities for these assets through partnerships, licensing, or the filing of IND applications in the future.

Summary

We expect to generate value for our shareholders by developing novel therapeutics. We seek to become profitable by commercializing a subset of therapeutics stemming from our development pipeline, and establishing partnerships with pharmaceutical and biotechnology companies for the development and commercialization of other therapeutics from our development pipeline. Our failure to successfully develop and commercialize pharmaceutical products would materially and adversely affect our business, financial condition, cash and investments balances and results of operations. Royalties or other revenue generated from commercial sales of products developed through the application of our technologies and expertise are not expected for several years, if at all. We expect that our revenue or income sources for at least the next several years may be limited to potential milestones and other potential payments related to partnering one of our drug candidates, and interest income.

 

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While we will continue to explore alternative sources to finance our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including the sale of certain assets, contributions by others to joint ventures, and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our shareholders to lose all or a substantial portion of their investment.

We expect to continue incurring substantial expenses relating to our research and development efforts, as we focus on: preclinical studies and clinical trials required for the development of therapeutic protein, antibody and small molecule product candidates; external programs identified by our platform as being promising and synergistic with our products and expertise. Conducting clinical trials is a lengthy, time-consuming and expensive process. We will incur substantial expenses for, and devote a significant amount of time to, these studies. As a result, we expect to incur continued losses over the next several years. Results of operations for any period may be unrelated to the results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results.

Critical Accounting Policies and Use of Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities, revenues and expenses. On an on-going basis, we evaluate our estimates, including those related to prepaid expenses, accrued expenses, revenue recognition, and stock based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 1 to our consolidated financial statements, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our consolidated financial statements:

Revenue Recognition

Overview

We recognize revenue when all four criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products has occurred or services have been rendered; (3) the selling price is fixed or determinable; and (4) the collectibility is reasonably assured, in accordance with Securities and Exchange Commission Staff Accounting Bulletin No. 104, “Revenue Recognition,” which sets forth guidelines for the timing of revenue recognition based upon factors such as passage of title, installation, payment and customer acceptance. Determination of criteria (2) and (3) are based on management’s judgment regarding delivery of products and the fee charged for products delivered.

Collaboration Revenue

During 2007, we recognized collaboration revenue related to the grant of exclusive worldwide rights by our collaboration partner TopoTarget to an unrelated third party of a preclinical HDAC inhibitor for potential use in the field of dermatology. Under our collaboration agreement with TopoTarget, we are entitled to receive 50% of

 

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initial payments received by TopoTarget from such third party. During 2006, we received $1.3 million which is currently being amortized on a straight line basis commencing in November 2006, the month the agreement was signed, through April 2022, the date the first original patent will expire in the United States. However, in the event that the third party terminates its license agreement with TopoTarget, all unrecognized revenue will be recognized upon termination. We estimated the time period and method of amortization in recording revenue under this agreement. In January 2008, TopoTarget was informed by the third party that it will be terminating the development of the preclinical compound in 2008 and as such the remaining unrecognized revenue of $1.2 million as of December 31, 2007 is expected to be recognized by us in 2008.

Collaboration revenue during 2006 and 2005 was generated primarily under our Pharmacogenomics Agreement with Bayer, or the Bayer Agreement. Payments received under the terms of the Bayer Agreement consisted of non-refundable fixed quarterly payments received in advance under the Bayer Agreement, which was completed in 2006.

The non-refundable fixed quarterly payments received in advance under the Bayer Agreement related to our future performance of services and were deferred and recognized as revenue when the future performance occurred, based upon the satisfaction of defined metrics of completion, as outlined in the Bayer Agreement, which included proportional performance and project specific deliverables. These metrics were reviewed internally each month to determine the work performed, deliverables met, and, if required, deliverables accepted by Bayer. We estimated the time period over which services were provided and the level of effort in each period. We made judgments based upon the facts and circumstances known to us at the time and in accordance with generally accepted accounting principles.

Accrued and Prepaid Expenses

We review new and open contracts, communicate with our applicable personnel to identify services that have been performed on our behalf and estimate the level of service performed and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost for accrued expenses. We also review, with our applicable personnel, services that have been performed when payment was required in advance and estimate the level of service performed and the associated cost incurred. The majority of our service providers invoice us monthly in arrears for services performed, however, some required advanced payments. We make estimates of our accrued and prepaid expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us. We also periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. To date, we have not adjusted our estimates at any particular balance sheet date in any material amount. Examples of estimated accrued and prepaid expenses include:

 

   

fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials;

 

   

fees paid to investigative sites in connection with clinical trials;

 

   

fees paid to contract manufacturers in connection with the production of clinical trial materials; and

 

   

professional service fees.

We base our accrued and prepaid expenses related to clinical trials on our estimates of the services received and efforts expended related to clinical trials all pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. We estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we will adjust accordingly. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.

 

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Stock-Based Compensation

We utilized the modified prospective transition method to adopt Statement of Financial Accounting Standards No. 123 (revised 2004) “Share Based Payment”, or SFAS 123R on January 1, 2006. Under this method, the provisions of SFAS 123R apply to all awards granted or modified after the date of adoption. In addition, the unrecognized expense of awards not yet vested at the date of adoption, determined under the original provisions of Statement of Financial Accounting Standards No. 123 “Accounting for Share-Based Payment”, or SFAS 123, are recorded in net income (loss) in the periods after the date of adoption. Prior to January 2006, we accounted for stock options under the intrinsic value method described in Accounting Principals Board Opinion No. 25, or APB 25, and related Interpretations as permitted by SFAS 123. When applying the intrinsic value method to stock options, we did not record stock-based compensation cost in net income (loss) because the exercise price of our stock options equaled the market price of the underlying stock on the date of grant. Estimates in recording employee stock option expense include utilizing the Black-Scholes option valuation method to estimate the fair value of stock options granted to employees and the number of options that will be forfeited due to employee terminations. The Black-Scholes option valuation method requires inputs for the following three factors: (1) volatility, (2) risk-free interest rate, and (3) expected term of the option. We use historical volatility to determine the expected stock price volatility factor; risk-free interest rates are based on the U.S. Treasury yield curve in effect at the time of grant, for the period corresponding to the approximate expected term of the options; and the expected term has been calculated using the criteria outlined in SAB 107. We estimate future forfeitures of stock options primarily based on historical experience. For additional information on stock-based compensation, please see Note 1 to our condensed consolidated financial statements included in this Annual Report on Form 10-K.

Results of Operations

Year 2007 Compared to Year 2006

The following table sets forth a comparison of the components of our net income (loss) for the years ended December 31, 2007 and 2006 (in millions):

 

     2007     2006     $
Change
    %
Change
 

Collaboration revenue

   $ 0.1     $ 2.3     $ (2.2 )   (96 )%

Research and development expenses

     36.8       44.0       (7.2 )   (16 )%

General and administrative expenses

     11.7       13.6       (1.9 )   (14 )%

Restructuring and related charges

     11.3       0.0       11.3     *  

Interest income

     5.6       7.2       (1.6 )   (22 )%

Interest expense

     5.2       9.4       (4.2 )   (45 )%

Realized gain on sale of available-for-sale investments, net

     0.7       0.0       0.7     *  

Gain on extinguishment of debt

     8.4       0.0       8.4     *  

Income tax benefit

     0.2       0.4       (0.2 )   (50 )%
                    

Loss from continuing operations

     (50.0 )     (57.1 )     (7.1 )   (12 )%

Income (loss) from discontinued operations

     75.4       (2.7 )     78.1     *  
                    

Net income (loss)

   $ 25.4     $ (59.8 )    
                    

 

* Based on prior year amounts, percentage change does not provide meaningful information.

Collaboration revenue.    The decrease in collaboration revenue for year ended December 31, 2007, as compared to the year ended December 31, 2006 was due to the completion of work under the Bayer Agreement during 2006. We do not expect to recognize any additional collaboration revenue during 2008, with the exception of collaboration revenue related to the amortization of the $1.3 million received during 2006 from TopoTarget’s licensing agreement with an unrelated third party. In January 2008, TopoTarget was informed by the third party that it will be terminating the development of the preclinical compound pursuant to which we receive collaboration revenue. Due to the termination of this agreement, we expect to recognize approximately $1.2 million of collaboration revenue in 2008.

 

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Research and development expenses.    Research and development expenses consist primarily of: contractual and manufacturing costs; salary and benefits; license fees and milestone payments; supplies; drug supply; depreciation and amortization; and allocated facility costs. Historically, our research and development efforts have been concentrated on three major project areas: clinical trials; preclinical drug candidates; and collaborations. However, upon completion of our work on the Bayer Agreement during the second quarter of 2006, and subsequent to our decision in the first quarter of 2007 to focus our resources exclusively on generating clinical trial results from our lead oncology drug development programs, our research and development efforts are now being concentrated solely on clinical trials. We budget and monitor our research and development costs by expense category, rather than by project, because these costs often benefit multiple projects and/or our technology platform.

Below is a summary that reconciles our total research and development expenses for the years ended December 31, 2007 and 2006 by the major categories (in millions):

 

     2007    2006    $
Change
    %
Change
 

Contractual and manufacturing costs

   $ 20.9    $ 19.6    $ 1.3     7 %

Salary and benefits

     9.1      11.0      (1.9 )   (17 )%

Supplies

     0.7      1.9      (1.2 )   (63 )%

License fees and milestone payments

     0.1      1.3      (1.2 )   (92 )%

Depreciation and amortization

     1.2      2.8      (1.6 )   (57 )%

Allocated facility costs

     4.8      7.4      (2.6 )   (35 )%
                  

Total research and development expenses

   $ 36.8    $ 44.0     
                  

The decrease in our research and development expenses for the year ended December 31, 2007 as compared to the year ended December 31, 2006 was due to our decision in the first quarter of 2007 to focus our resources exclusively on generating clinical trial results from our lead oncology drug development programs, as well as the second quarter 2007 restructuring, which included the closing of our Biopharmaceutical Sciences Process facility, or BPS, and the third quarter 2007 restructuring related to the termination of velafermin and personnel reductions. The reductions included a decrease in supplies, a decrease in salary and benefits caused by a reduction in personnel, a decrease in depreciation and amortization from a reduction in lab equipment and a decrease in allocated facility costs. We did have an increase in contractual and manufacturing costs due to higher clinical trial expenses related to velafermin and new Phase I/II studies for belinostat in 2007 compared to 2006. We anticipate our research and development expenses for 2008 will decrease as compared to research and development expenses for 2007 in contractual and manufacturing costs as we have discontinued clinical trials in velafermin and will only incur patient follow up cost through 2008.

As soon as we advance a potential clinical candidate into clinical trials, we begin to track the direct research and development expenses associated with that potential clinical candidate. The following table shows the cumulative direct research and development expenses as of December 31, 2007, as well as the current direct research and development expenses for the years ended December 31, 2007 and 2006 which were incurred on or after we started conducting a Phase I clinical trial for a clinical candidate (in millions):

 

          Clinical Development Costs     

Therapeutic Area and

Clinical Candidate

  

Class

   Cumulative as of
December 31,
2007 (since
commencement
of Phase I trial)
   Year Ended
December 31,
2007
   Year Ended
December 31,
2006
   Indication

Oncology

              

Belinostat

   Small Molecule    $ 44.1    $ 13.6    $ 11.4    Various Cancers

CR011-vcMMAE

   Antibody-Drug Conjugate    $ 7.1    $ 2.7    $ 4.4    Metastatic
Melanoma

Cancer Supportive Care

              

Velafermin

   Protein    $ 50.3    $ 13.2    $ 11.5    Oral Mucositis

 

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We expect that the direct research and development expenses incurred in connection with our development of belinostat to decrease in 2008 as compared to 2007 due to the several clinical trials completing enrollment in 2008. We will support a Phase III or registrational program that we expect to initiate in the second half of 2008, pending positive data from the ongoing Phase II trial expected during the first half of 2008. We expect that the direct research and development expenses incurred in connection with our development of CR011-vcMMAE will increase in 2008 as compared to 2007. The expected increase during 2008 is related to higher enrollment of patients into our ongoing Phase I/II trial, and milestone payments due in 2008 upon initiating a Phase II trial, pending positive data from the ongoing Phase I/II trials. We expect that the direct research and development expenses incurred in connection with our development of velafermin will decrease in 2008 as compared to 2007. Although we completed enrollment in our Phase II trial in August 2007 and discontinued further investment in our velafermin program, additional costs associated with planned safety follow up visits and other trial close out activities will be incurred through the third quarter of 2008.

Currently, our potential pharmaceutical products require significant research and development efforts and preclinical testing, and will require extensive evaluation in clinical trials prior to submitting an application to regulatory agencies for their commercial use. Although we are conducting, or have conducted, human studies with respect to belinostat, and CR011-vcMMAE, we may not be successful in developing or commercializing these or other products. Our product candidates are subject to the risks of failure inherent in the development and commercialization of pharmaceutical products and we cannot currently provide reliable estimates as to when, if ever, our product candidates will generate revenue and cash flows.

Completion of research and development, preclinical testing and clinical trials may take many years. Estimates of completion periods for any of our major research and development projects are highly speculative and variable, and dependent on the nature of the disease indication, how common the disease is among the general populace, and the results of the research. For example, preclinical testing and clinical trials can often go on for an indeterminate period of time since the results of tests are continually monitored, with each test considered “complete” only when sufficient data has been accumulated to assess whether the next phases of clinical trials are warranted or whether the effort should be abandoned. Typically, Phase I clinical trials are expected to last between 12 and 24 months, Phase II clinical trials are expected to last between 24 and 36 months and Phase III clinical trials are expected to last between 24 and 60 months. The most significant time and costs associated with clinical development are the Phase III trials as they tend to be the longest and largest studies conducted during the drug development process.

In addition, many factors may delay the commencement and speed of completion of preclinical testing and clinical trials, including, but not limited to, the number of patients participating in the trial, the duration of patient follow-up required, the number of clinical sites at which the trials are conducted, and the length of time required to locate and enroll suitable patient subjects. The successful completion of our development programs and the successful development of our product candidates are highly uncertain and are subject to numerous challenges and risks. Therefore, we cannot presently estimate anticipated completion dates for any of our projects.

Due to the variability in the length of time necessary to develop a product candidate, the uncertainties related to the cost of projects and the need to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate costs to bring our product candidates to market are not available. If our major research and development projects are delayed, then we can expect to incur additional costs in conducting our preclinical testing and clinical trials, and that it will be a longer period of time before we might achieve profitability from our operating activities. Accordingly, the timing of the potential market approvals for our existing product candidates belinostat, and CR011-vcMMAE, and future product development candidates, may have a significant impact on our capital requirements.

General and administrative expenses.    The decrease in general and administrative expenses for the year ended December 31, 2007, as compared to the year ended December 31, 2006, was primarily a result of our restructuring activities through 2007 related to personnel reductions, a decrease in outsourcing of consultants and lower patent legal fees. Our general and administrative expenses are expected to decrease for the full year 2008 as compared to 2007 due to less personnel.

 

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Restructuring and related charges.    During June and September 2007, we underwent corporate restructurings to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development, resulting in full year 2007 restructuring charges of $11.3 million. This amount includes an asset impairment charge of $6.3 million (associated with the closure of BPS, on July 27, 2007), $4.4 million related to employee separation costs paid in cash, $0.3 million of non-cash employee separation costs and $0.3 million of other asset write-offs. As of December 31, 2007, the majority of the assets included in the $6.3 million asset impairment charge had been sold to various third parties. The cash requirements under the 2007 restructuring plans were $4.4 million, of which $1.6 million was paid prior to December 31, 2007.

Interest income.    Interest income for the year ended December 31, 2007 decreased as compared to the year ended December 31, 2006 due to a reduction in our cash balance and investment portfolio. Our lower cash balance was due to: the repayment of $66.2 million of our 6% convertible subordinated debentures which occurred upon their maturity in February 2007 and $31.4 million of our 4% convertible subordinated debentures due 2011; cash used from operations of $43.8 million, offset by the receipt of an aggregate of $91.0 million from the sale of 454, the sale of our TopoTarget investment, and the sales of certain capital equipment. We earned an average yield of 4.3% during 2007 as compared to 3.9% in 2006. We anticipate interest income to decrease in 2008 compared to 2007, due to lower cash and investment balances caused by the utilization of cash and investment balances in the normal course of operations. We also expect the yields in our investment portfolio to slightly decrease during 2008.

Interest expense.    Interest expense for the year ended December 31, 2007 decreased compared to the same period in 2006 primarily due to the $66.2 million repayment of our 6% convertible subordinated debentures which occurred upon their maturity in February 2007, and the total 2007 repurchases of $40.1 million of our 4% convertible subordinated debentures due 2011. We expect interest expense, including interest paid to debt holders as well as amortization of deferred financing costs, to decrease during 2008 as compared to 2007 due to the debt repurchases in the second half of 2007.

Realized gain on sale of available-for-sale investments, net.    During 2007, we had a net gain on sale of “available-for sale” investments of $0.7 million due to a $1.0 million gain from the sale of our investment in TopoTarget, partially offset by a $0.3 million loss on the sale of a debt investment.

Gain on extinguishment of debt.    During 2007, we repurchased a total of $40.1 of our 4% outstanding convertible subordinated debentures due February 2011, for a gain of $8.4 million in “Gain on extinguishment of debt,” which is net of the write-off of the ratable portion of unamortized deferred financial costs relating to the repurchased debt.

Income tax benefit.    We recorded an income tax benefit of $0.2 million during the year ended December 31, 2007 as a result of Connecticut legislation, which allows companies to obtain cash refunds from the State of Connecticut at a rate of 65% of their annual research and development expense credit, in exchange for forgoing carryforward of the research and development credit. For the years ended December 31, 2007 and 2006, the income tax benefit included adjustments resulting from the expiration of the State of Connecticut statute of limitations, as they relate to the Year 2002 and Year 2001 income tax benefit, respectively. We expect the 2008 income tax benefit to decrease in 2008 due to anticipated lower research and development expenditures next year.

Loss from discontinued operations.    Due to the sale of our ownership in 454 in the second quarter of 2007, the results of 454’s operations have been reclassified as discontinued operations for all periods presented. The income from discontinued operations for the year ended December 31, 2007 as compared to 2006 was due to the sale of 454 to Roche Diagnostics Operations Inc,. or RDO, during the second quarter of 2007. During 2006, the cumulative losses applicable to the minority interest in subsidiary exceeded the minority interest in the equity capital of 454, and therefore all losses applicable to the minority interest for the year 2006 through the closing of the sale of 454 to RDO on May 25, 2007 were charged to us. Our net gain of $75.4 million consists of

 

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$78.4 million gain on the sale of 454 offset by $3.0 million loss from discontinued operations. This assumes we will collect our $14.1 million of $25 million held in escrow to provide for certain post-closing adjustments based on 454’s net working capital and net debt on May 25, 2007, and to secure the indemnification rights of RDO and its affiliate.

Year 2006 Compared to Year 2005

The following table sets forth a comparison of the components of our net loss for the years ended December 31, 2006 and 2005 (in millions):

 

     2006     2005     $
Change
    %
Change
 

Collaboration revenue

   $ 2.3     $ 4.8     $ (2.5 )   (52 )%

Research and development expenses

     44.0       57.5       (13.5 )   (23 )%

General and administrative expenses

     13.6       12.2       1.4     11 %

Restructuring and related charges

     0.0       2.8       (2.8 )   (100 )%

Interest income

     7.2       8.0       (0.8 )   (10 )%

Interest expense

     9.4       11.7       (2.3 )   (20 )%

Gain on extinguishment of debt

     0.0       1.8       (1.8 )   (100 )%

Income tax benefit

     0.4       0.4       0.0     0 %
                    

Loss from continuing operations

     (57.1 )     (69.2 )     (12.1 )   (17 )%

Income (loss) from discontinued operations

     (2.7 )     (4.0 )     (1.3 )   (33 )%
                    

Net loss

   $ (59.8 )   $ (73.2 )    
                    

Collaboration revenue.    The decrease in our collaboration revenue for year ended December 31, 2006, as compared to the year ended December 31, 2005 was due to the completion of work under the Pharmacogenomics Agreement with Bayer during the second quarter of 2006.

Research and development expenses.    Research and development expenses consist primarily of: contractual and manufacturing costs of our drug pipeline; salary and benefits; license fees and milestone payments; supplies and reagents; depreciation and amortization; and allocated facility costs. Our research and development efforts are concentrated on three major project areas: clinical candidates; preclinical drug candidates; and collaborations. We budget and monitor our operational research and development costs by expense category, rather than by project, because these costs often benefit multiple projects.

Below is a summary that reconciles our total research and development expenses for the years ended December 31, 2006 and 2005 by the major categories mentioned above (in millions):

 

     2006    2005    $
Change
    %
Change
 

Contractual and manufacturing costs

   $ 19.6    $ 20.6    $ (1.0 )   (5 )%

Salary and benefits

     11.0      11.0      0.0     0 %

License fees and milestone payments

     1.3      10.9      (9.6 )   (88 )%

Supplies and reagents

     1.9      4.4      (2.5 )   (59 )%

Depreciation and amortization

     2.8      3.3      (0.5 )   (14 )%

Allocated facility costs

     7.4      7.3      0.1     5 %
                  

Total research and development expenses

   $ 44.0    $ 57.5     
                  

The decrease in research and development expenses for the year ended December 31, 2006, as compared to the year ended December 31, 2005, was primarily due to 2005 license fees and milestone payments of approximately $10.9 million (primarily related to our collaborations with TopoTarget, Seattle Genetics and the

 

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Bayer metabolic disorder collaboration), a decrease in contractual and manufacturing costs, a decrease in supplies and reagents, and a decrease in salary and benefits caused by a decrease in personnel, offset by a second quarter 2006 milestone payment (related to our collaboration with Seattle Genetics) and increased non-cash expenses in 2006 related to stock options and restricted stock recorded under SFAS 123R.

As soon as we advance a potential clinical candidate into clinical trials, we begin to track the direct research and development expenses associated with that potential clinical candidate. The following table shows the cumulative direct research and development expenses as of December 31, 2006, as well as the current direct research and development expenses for the years ended December 31, 2006 and 2005 which were incurred on or after we started conducting a Phase I clinical trial for a clinical candidate (in millions):

 

          Clinical Development Costs     

Therapeutic Area and

Clinical Candidate

   Class    Cumulative as of
December 31,
2006 (since
commencement
of Phase I trial)
   Year Ended
December 31,
2006
   Year Ended
December 31,
2005
   Indication

Oncology

              

Belinostat

   Small Molecule    $ 30.4    $ 11.4    $ 16.4    Various Cancers

CR011-vcMMAE

   Antibody-Drug
Conjugate
   $ 4.4    $ 4.4      —      Metastatic
Melanoma

Cancer Supportive Care

              

Velafermin

   Protein    $ 37.1    $ 11.5    $ 8.9    Oral Mucositis

General and administrative expenses.    The increase in our general and administrative expenses for the year ended December 31, 2006, as compared to the year ended December 31, 2005, was primarily a result of an increase during 2006 in executive recruiting costs, consulting and legal fees incurred in connection with the strategic review of 454 and other financing efforts, and non-cash expenses for stock options and restricted stock recorded under SFAS 123R.

Restructuring and related charges.    In 2006 there were no restructuring and related charges. In connection with the 2005 restructuring plan, we recorded a charge of $2.8 million, including $1.1 million related to employee separation costs, $1.5 million of operating lease obligations and $0.2 million of asset impairment costs. The cash requirements under the 2005 restructuring plan were $2.5 million, of which $1.0 million was paid prior to December 31, 2006.

Interest income.    Interest income for year ended December 31, 2006 decreased as compared to 2005 primarily due to lower cash and investment balances, offset by higher yields on our investment portfolio. We earned an average yield of 3.9% during 2006 as compared to 2.8% in 2005.

Interest expense.    Interest expense for the year ended December 31, 2006 decreased as compared to 2005 primarily due to the repurchases in 2005 of $63.8 million of our 6% convertible subordinated debentures due 2007.

Gain on extinguishment of debt.    In 2006, we did not repurchase any of our outstanding convertible subordinated debentures. During 2005, we repurchased $63.8 million of our 6% convertible subordinated debentures due February 2007, for total consideration of $61.5 million, plus accrued interest to the date of repurchase of $1.2 million. As a result of these transactions we recorded a gain of $1.8 million in “Gain on extinguishment of debt,” which is net of the write-off of the ratable portion of unamortized deferred financing costs relating to the repurchased debt.

Income tax benefit.    We recorded an income tax benefit of $0.4 million during the year ended December 31, 2006 as a result of Connecticut legislation, which allows companies to obtain cash refunds from the State of Connecticut at a rate of 65% of their annual research and development expense credit, in exchange

 

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for forgoing carryforward of the research and development credit. For the years ended December 31, 2006 and 2005, the income tax benefit included adjustments resulting from the expiration of the State of Connecticut statute of limitations, as they relate to the Year 2002 and Year 2001 income tax benefit, respectively.

Loss from discontinued operations.    Due to the sale of our ownership in 454 in the second quarter of 2007, the results of 454’s operations have been reclassified as discontinued operations for all periods presented.

Liquidity and Capital Resources

Since our inception, we have financed our operations and met our capital expenditure requirements primarily through: private placements of equity securities; convertible subordinated debt offerings; public equity offerings; and revenues received under our collaborative research agreements. Since inception, we have not had any off-balance sheet arrangements. To date, inflation has not had a material effect on our business.

During 2007, we monetized several assets, including $82 million from the sale of 454 to RDO, $2.6 million from the sale of fixed assets as part of the corporate restructurings, and $6.3 million from the sale of an investment in TopoTarget. Additionally, we repaid $66.2 million of our 6% convertible subordinated debt at face value upon maturity and paid $31.0 million to extinguish $40.1 million of our 4% convertible subordinated debt in privately negotiated transactions.

We also underwent corporate restructurings to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development, resulting in a 2007 restructuring charge of $11.3 million. We anticipate a reduction of our cash required for operating expenses in 2008.

Cash and investments.    The following table depicts changes in the cash and investments for the years ended December 31, 2007 and 2006, using the direct method (in millions):

 

     2007     2006  

Cash received from collaborators

   $ 0.9     $ 0.4  

Cash paid to suppliers and employees

     (41.7 )     (47.2 )

Restructuring charges paid

     (2.4 )     (1.5 )

Interest income received

     5.5       7.2  

Interest expense paid

     (6.9 )     (8.5 )

Income tax benefit received

     0.4       1.1  

Cash paid to acquire property and equipment

     (0.2 )     (0.4 )

Proceeds from sale of fixed assets

     —         0.2  

Proceeds from sale of held for sale assets

     2.6       —    

Proceeds from sale of long-term marketable securities

     6.3       —    

Proceeds from disposal of assets of discontinued operations

     82.0       —    

Cash received from employee stock option exercises

     0.1       0.6  

Repayment of convertible debt

     (66.2 )     —    

Cash paid for extinguishment of debt

     (31.0 )     —    

Net realized and unrealized gain on short-term investments and marketable securities

     1.2       1.3  
                

Net decrease in cash and investments

     (49.4 )     (46.8 )

Cash and investments, beginning of period

     164.4       211.2  
                

Cash and investments, end of period

   $ 115.0     $ 164.4  
                

In accordance with our investment policy, we are utilizing the following investment objectives for cash and investments: (1) investment decisions are made with the expectation of minimum risk of principal loss, even with a modest penalty in yield; (2) appropriate cash balances and related short-term funds are maintained for immediate liquidity needs, and appropriate liquidity is available for medium-term cash needs; and (3) maximum yield is achieved.

 

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Future Liquidity.    We expect to continue to fund our operations into 2011 through a combination of the following sources: cash and investment balances; interest income; partnering our products; potential public securities offerings; and/or private strategic-driven transactions. We plan to use the proceeds from the assets monetized in 2007 to continue generating clinical trial results from our two late stage oncology programs, belinostat and CR011-vcMMAE, which may potentially enable us to bring one of these products into Phase III trials during 2008. During 2008 we plan to continue making substantial investments to advance our clinical drug pipeline. We do not anticipate any material capital expenditures in the near future. Accordingly, we foresee the following as significant uses of liquidity: contractual services related to clinical trials and manufacturing; salary and benefits; license fees; potential milestone payments; and payments of interest to the holders of our convertible subordinated debt due in 2011.

We will continue to evaluate options to repurchase or refinance a portion of our outstanding 4% convertible debentures that mature on February 15, 2011. Repurchases might occur through cash purchases and/or exchange for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions and other factors. The amounts involved in any such transactions, individually or in the aggregate, may be material. We may use sources of liquidity for working capital, and for general corporate purposes and potentially for future acquisitions of complementary businesses or products or technologies. The amounts and timing of our actual expenditures will depend upon numerous factors, including the amount and extent of our acquisitions, our product development activities, and our investments in technology and the amount of cash generated by our operations. Actual expenditures may vary substantially from our estimates. Our failure to use sources of liquidity effectively could have a material adverse effect on our business, results of operations and financial condition.

We believe that our existing cash and investment balances and other sources of liquidity will be sufficient to meet our requirements into 2011. We consider our operating and capital expenditures to be crucial to our future success, and by continuing to make strategic investments in our clinical drug pipeline, we believe that we are building substantial value for our shareholders. The adequacy of our available funds to meet our future operating and capital requirements, including the repayment of the $69.9 million of 4% convertible subordinated notes due February 15, 2011, will depend on many factors. These factors include: the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our products; in-licensing and out-licensing of pharmaceutical products; costs incurred in enforcing and defending our patent claims; other intellectual property rights; and the extent to which RDO makes successful claims for indemnification under the Merger Agreement relating to the sale of 454. As of February 29, 2008 there were no claims made for indemnification.

While we will continue to explore alternative sources for financing our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our shareholders to lose all or a substantial portion of their investment.

Contractual Obligations

In the table below, we set forth our enforceable and legally binding obligations, along with future commitments related to all contracts that we are likely to continue, regardless of the fact that they are cancelable as of December 31, 2007.

 

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Some of the amounts we include in this table under purchase commitments are based on management’s estimates and assumptions about these obligations, including their duration, anticipated actions by third parties, progress of our clinical programs and other factors (in millions).

 

     Payments Due
Year Ended December 31,
     Total    2008    2009    2010    2011    Thereafter

Long-term debt obligations (1)

   $ 69.9    $ —      $ —      $ —      $ 69.9    $ —  

Interest on convertible subordinated debt (1)

     9.8      2.8      2.8      2.8      1.4      —  

Operating leases (2)

     0.7      0.7      —        —        —        —  

Purchase commitments (3)

     8.3      7.7      0.5      —        —        —  
                                         

Total

   $ 88.6    $ 11.2    $ 3.3    $ 2.8    $ 71.3    $ —  
                                         

 

(1) Refer to Note 7 to our consolidated financial statements for additional discussion.
(2) Refer to Note 3 to our consolidated financial statements for additional discussion.
(3) Includes: commitments for costs associated with our clinical trial development and other supporting arrangements, which are subject to certain limitations and in certain circumstances cancellation clauses. Excludes amounts included on our balance sheet as liabilities and certain purchase obligations and potential future milestone payments as discussed below.

The expected timing of payment of the obligations discussed above is estimated based on current information. Timing of payments and actual amounts paid may be different depending on the time of receipt of goods or services or changes to agreed-upon amounts for some obligations.

For the purposes of this table, contractual obligations for purchase of goods or services are defined as agreements that are enforceable and legally binding on us and that specify all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. Our purchases are based on current operating needs and are fulfilled by vendors within short time periods. We have unrecognized tax benefits of $0.9 million at December 31, 2007. This amount is excluded from the table above as we are unable to make a reasonable estimate of the period of cash settlement with the respective taxing authority.

In addition, we have committed to make potential future milestone payments to third-parties as part of in-licensing and development programs. Payments under these agreements generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable, such contingencies have not been recorded on our consolidated balance sheet and are not included above.

Income Taxes

As of December 31, 2007, we have tax net operating loss carryforwards available to reduce future federal and Connecticut taxable income, research and development tax credit carryforwards available to offset future federal and Connecticut income taxes. Utilization of the net operating loss and tax credit carryforwards may be limited due to changes in our ownership, as defined within Section 382 of the Internal Revenue Code (in thousands).

 

     Net Operating Loss Carryforwards   
     Federal    Expire In    Connecticut    Expire In     
   $ 532,514    2009 to 2028    $ 469,485    2021 to 2028   
Research and Development Tax Credit Carryforwards
     Federal    Expire In    Connecticut    Expire In     
   $ 20,184    2009 to 2028    $ 14,233    2014 to 2023   

 

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Recently Enacted Pronouncements

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements.”, or SFAS 157. SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles, and expands disclosures about fair value measurements. On November 14, 2007, the FASB authorized its staff to draft a proposed FASB Staff Position that would partially defer the effective date of SFAS 157 for one year for non-financial assets and non-financial liabilities that are recognized or disclosed at fair value in the financial statements on a nonrecurring basis. SFAS 157 does not require any new fair value measurements; rather, it applies under other accounting pronouncements that require or permit fair value measurements. The provisions of SFAS 157 are to be applied prospectively as of the beginning of the fiscal year in which it is initially applied, with any transition adjustment recognized as a cumulative-effect adjustment to the opening balance of retained earnings. Notwithstanding the potential effective date deferral discussed above, SFAS 157 is effective for fiscal years beginning after November 15, 2007. We do not believe the adoption of SFAS 157 will have a material impact on our consolidated financial statements.

In June 2007, the FASB ratified the Emerging Issues Task Force, or EITF, consensus on Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities”, or EITF 07-3. EITF 07-3 requires that nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. Such amounts should be recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. EITF 07-3 is effective for fiscal years beginning after December 15, 2007, and interim periods within those fiscal years. We do not believe the adoption of EITF 07-3 will have a material impact on our consolidated financial statements.

In December 2007, the FASB ratified the EITF consensus on Issue No. 07-1, “Accounting for Collaborative Arrangements”, or EITF 07-1. The EITF concluded that a collaborative arrangement is one in which the participants are actively involved and are exposed to significant risks and rewards that depend on the ultimate commercial success of the endeavor. Revenues and costs incurred with third parties in connection with collaborative arrangements would be presented gross or net based on the criteria in EITF 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent, and other accounting literature. Payments to or from collaborators would be evaluated and presented based on the nature of the arrangement and its terms, the nature of the entity’s business, and whether those payments are within the scope of other accounting literature EITF 07-1 is effective for fiscal years beginning after December 15, 2008. We do not believe the adoption of EITF 07-1 will have a material impact on our consolidated financial statements.

In December 2007, the SEC issued Staff Accounting Bulletin No. 110, or SAB 110. SAB 110 expresses the views of the staff regarding the use of a “simplified” method, as discussed in SAB No. 107, or SAB 107, in developing an estimate of expected term of “plain vanilla” share options in accordance with Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment. In particular, the staff indicated in SAB 107 that it will accept a company’s election to use the simplified method, regardless of whether the company has sufficient information to make more refined estimates of expected term. At the time SAB 107 was issued, the staff believed that more detailed external information about employee exercise behavior (e.g., employee exercise patterns by industry and/or other categories of companies) would, over time, become readily available to companies. Therefore, the staff stated in SAB 107 that it would not expect a company to use the simplified method for share option grants after December 31, 2007. The staff understands that such detailed information about employee exercise behavior may not be widely available by December 31, 2007. Accordingly, the staff will continue to accept, under certain circumstances, the use of the simplified method beyond December 31, 2007. We are in the process of evaluating the provisions of SAB 110 and do not believe the adoption of SAB 110 will have a material impact on our consolidated financial statements.

 

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Currently, we maintain approximately 15% of our cash, investments and restricted cash in financial instruments with original maturity dates of three months or less, 17% in financial instruments with original maturity dates of greater than three months and less than one year, 56% in financial instruments with original maturity dates of equal to or greater than one year and less than five years, and the remaining 12% in restricted cash which is currently being held in escrow to secure the indemnification rights of RDO and its affiliates from the sale of 454. These financial instruments are subject to interest rate risk and will decline in value if interest rates increase. These investments have no risk related to foreign currency exchange or commodity prices. We estimate that a change of 100 basis points in interest rates would result in a $0.7 million decrease or increase in the fair value of our cash and investments.

We have 9% of our cash and investment securities in mortgage-backed securities. All of these mortgage backed securities are sponsored by the United States Federal Government and are rated AAA by Moody’s. Additionally, we have 23% of asset backed securities which consist of auto, credit card and equipment loans all with AAA ratings by Moody’s. The asset backed and mortgage backed securities have been priced by independent parties and trade at a net unrealized loss of $0.02 million and the largest unrealized loss on any individual security is $0.03 million. We believe that any individual unrealized loss as of December 31, 2007 represents only a temporary impairment, and no adjustment of carrying values is warranted at this time.

Our outstanding long-term liabilities as of December 31, 2007 include $69.9 million of our 4% convertible subordinated notes due February 15, 2011, and the long-term portion of deferred revenue in the amount of $1.1 million. As the notes bear interest at a fixed rate, our results of operations would not be affected by interest rate changes. Although future borrowings may bear interest at a floating rate, and would therefore be affected by interest rate changes, at this point we do not anticipate any significant future borrowings at floating interest rates, and therefore do not believe that a change of 100 basis points in interest rates would have a material effect on our financial condition.

Accordingly, we do not believe that there is any material market risk exposure with respect to derivative or other financial instruments that would require disclosure under this item.

As of December 31, 2007, the market value of our $69.9 million 4% convertible subordinated notes due 2011, based on quoted market prices, was approximately $50.1 million.

 

Item 8. Financial Statements and Supplementary Data

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

 

     December 31,  
     2007     2006  
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 16,730     $ 58,486  

Restricted cash

     14,533       —    

Short-term investments

     19,039       23,473  

Marketable securities

     64,675       82,434  
                

Cash, restricted cash and investments

     114,977       164,393  

Accounts receivable

     —         926  

Income taxes receivable

     419       543  

Prepaid expenses

     2,290       2,595  

Assets held for sale

     —         34,881  
                

Total current assets

     117,686       203,338  

Property and equipment, net

     479       12,215  

Intangible and other assets, net

     1,117       11,741  
                

Total assets

   $ 119,282     $ 227,294  
                
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 254     $ 320  

Accrued expenses

     3,140       3,289  

Accrued payroll and related items

     1,613       1,810  

Interest payable

     1,048       3,306  

Current portion of deferred revenue

     89       89  

Other current liabilities

     3,698       1,576  

Current portion of convertible subordinated debt

     —         66,228  

Liabilities held for sale

     —         30,735  
                

Total current liabilities

     9,842       107,353  
                

Long-term liabilities:

    

Convertible subordinated debt, net of current portion

     69,890       110,000  

Deferred revenue, net of current portion

     1,085       1,174  
                

Total long-term liabilities

     70,975       111,174  
                

Commitments and contingencies

    

Stockholders’ equity:

    

Common Stock; $.01 par value, issued and outstanding 58,074,127 shares at December 31, 2007, and 56,390,682 shares at December 31, 2006

     581       564  

Additional paid-in capital

     525,481       518,827  

Accumulated other comprehensive (loss) income

     (23 )     2,348  

Accumulated deficit

     (487,574 )     (512,972 )
                

Total stockholders’ equity

     38,465       8,767  
                

Total liabilities and stockholders’ equity

   $ 119,282     $ 227,294  
                

See accompanying notes to consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Year Ended December 31,  
     2007     2006     2005  

Revenue

      

Collaboration revenue

   $ 88     $ 2,298     $ 4,825  
                        

Total revenue

     88       2,298       4,825  
                        

Operating expenses

      

Research and development expenses

     36,778       44,009       57,461  

General and administrative expenses

     11,658       13,648       12,225  

Restructuring charges

     11,274       —         2,817  
                        

Total operating expenses

     59,710       57,657       72,503  
                        

Loss from operations

     (59,622 )     (55,359 )     (67,678 )

Interest income

     5,534       7,170       8,043  

Interest expense

     (5,167 )     (9,351 )     (11,701 )

Realized gain on sale of available-for-sale investments, net

     665       —         —    

Gain on extinguishment of debt

     8,442       —         1,766  
                        

Loss from continuing operations before income tax benefit

     (50,148 )     (57,540 )     (69,571 )

Income tax benefit

     185       376       403  
                        

Loss from continuing operations

     (49,963 )     (57,165 )     (69,168 )
                        

Discontinued Operations

      

Loss from discontinued operations

     (2,991 )     (2,675 )     (4,076 )

Gain on sale of subsidiary

     78,352       —         —    
                        

Income (loss) from discontinued operations

     75,361       (2,675 )     (4,076 )
                        

Net income (loss)

   $ 25,398       ($59,839 )     ($73,244 )
                        

Basic and diluted loss per share from continuing operations

   $ (0.89 )   $ (1.04 )   $ (1.33 )

Basic and diluted income (loss) per share from discontinued operations

   $ 1.34     $ (0.05 )   $ (0.08 )
                        

Basic and diluted net income (loss) per share

   $ 0.45     $ (1.09 )   $ (1.41 )
                        

Weighted average number of shares used in computing basic and diluted net income (loss) per share

     55,853       54,896       51,991  
                        

See accompanying notes to consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(in thousands, except share data)

 

    Number of
Shares
    Common
Stock
  Additional
Paid-in
Capital
    Accumulated
Other
Comprehensive
Income (Loss)
    Accumulated
Deficit
    Unamortized
Stock-Based
Compensation
    Total     Total
Comprehensive
Income (Loss)
 

January 1, 2005

  50,646,538     $ 506   $ 489,725       ($1,085 )   ($379,889 )     ($2,331 )   $ 106,926    

Net loss

  —         —       —         —       (73,244 )     —         (73,244 )     ($73,244 )

Unrealized losses on available-for-sale securities, net of reclassification adjustment (see disclosure below)

  —         —       —         (1,700 )   —         —         (1,700 )     (1,700 )
                     

Comprehensive loss

                  ($74,944 )
                     

Issuance of common stock, net of stock issuance costs

  4,000,000       40     20,808       —       —         —         20,848    

Issuance of restricted stock

  767,875       8     3,115       —       —         (3,115 )     8    

Retirement of restricted stock

  (78,200 )     —       (488 )     —       —         488       —      

Amortization and forfeitures of stock-based compensation

  —         —       —         —       —         1,942       1,942    

Employee stock option activity

  181,832       1     617       —       —         —         618    

Non-employee stock option activity

  30,000       —       659       —       —         —         659    

Stock-based 401(k) plan employer match

  94,035       1     426       —       —         —         427    
                                                   

December 31, 2005

  55,642,080     $ 556   $ 514,862       ($2,785 )   ($453,133 )     ($3,016 )   $ 56,484    

Net loss

  —         —       —         —       (59,839 )     —         (59,839 )     ($59,839 )

Unrealized gains on available-for-sale securities, net of reclassification adjustment (see disclosure below)

  —         —       —         5,133     —         —         5,133       5,133  
                     

Comprehensive loss

                  ($54,706 )
                     

Issuance of restricted stock

  455,000       5     —         —       —         —         5    

Retirement of restricted stock

  (31,625 )     —       —         —       —         —         —      

Reversal of unamortized stock-based compensation

  —         —       (3,016 )     —       —         3,016       —      

Employee stock option activity

  25,049       —       5,989       —       —         —         5,989    

Non-employee stock option activity

  216,000       2     657       —       —         —         659    

Stock-based 401(k) plan employer match

  84,178       1     335       —       —         —         336    
                                                   

December 31, 2006

  56,390,682     $ 564   $ 518,827     $ 2,348     ($512,972 )   $ 0     $ 8,767    

Net income

  —         —       —         —       25,398       —         25,398     $ 25,398  

Unrealized losses on available-for-sale securities, net of reclassification adjustment (see disclosure below)

  —         —       —         (2,371 )   —         —         (2,371 )     (2,371 )
                     

Comprehensive income

                $ 23,027  
                     

Issuance of restricted stock

  1,537,020       15     —         —       —         —         15    

Retirement of restricted stock

  (42,230 )     —       —         —       —         —         —      

Employee stock option activity

  19,400       1     6,521       —       —         —         6,522    

Non-employee stock option activity

  —         —       (219 )     —       —         —         (219 )  

Stock-based 401(k) plan employer match

  169,255       1     352       —       —         —         353    
                                                   

December 31, 2007

  58,074,127     $ 581   $ 525,481       ($23 )   ($487,574 )   $ 0     $ 38,465    
                                                   

See accompanying notes to consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY—(Continued)

(in thousands, except share data)

 

    Number of
Shares
  Common
Stock
  Additional
Paid-in
Capital
  Accumulated
Other
Comprehensive
Income (Loss)
  Accumulated
Deficit
  Unamortized
Stock-Based
Compensation
  Total   Total
Comprehensive
Income (Loss)
 

Disclosure of 2005 comprehensive loss reclassification adjustment:

               

Unrealized holding losses on available-for-sale securities arising during period

                ($ 1,896 )

Reclassification adjustment for losses included in net loss

                  196  
                                   

Unrealized losses on short-term investments and marketable securities, net of reclassification adjustment

                ($ 1,700 )
                                   

Disclosure of 2006 comprehensive loss reclassification adjustment:

               

Unrealized holding gains on available-for-sale securities arising during period

                $ 4,845  

Reclassification adjustment for losses included in net loss

                  288  
                                   

Unrealized gains on short-term investments and marketable securities, net of reclassification adjustment

                $ 5,133  
                                   

Disclosure of 2007 comprehensive loss reclassification adjustment:

               

Unrealized holding losses on available-for-sale securities arising during period

                ($ 1,706 )

Reclassification adjustment for gains included in net income

                  (665 )
                                   

Unrealized losses on short-term investments and marketable securities, net of reclassification adjustment

                ($ 2,371 )
                                   

See accompanying notes to consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

    Year Ended December 31,  
    2007     2006     2005  

Cash flows from operating activities:

     

Net income (loss)

  $ 25,398     ($ 59,839 )   ($ 73,244 )

(Income) loss from discontinued operations

    (75,361 )     2,675       4,076  

Adjustments to reconcile net income (loss) to net cash used in operating activities:

     

Deferred revenue, net of current portion

    (89 )     1,174       —    

Depreciation and amortization

    3,493       7,343       6,291  

Asset impairment expense

    6,322       —         188  

Non-monetary compensation

    3,539       5,345       2,572  

Stock-based 401(k) employer plan match

    353       335       427  

Non-cash interest income

    429       896       1,477  

Non-cash interest income—restricted cash

    (403 )     —         —    

Gain on extinguishment of debt

    (8,442 )     —         (1,766 )

Net gain on sale of available-for-sale investments

    (665 )     —         —    

Changes in assets and liabilities:

     

Accrued interest receivable

    357       267       505  

Income taxes receivable

    124       166       120  

Accounts receivable

    926       (871 )     (13 )

Prepaid expenses

    494       (836 )     344  

Other assets

    279       (139 )     (222 )

Accounts payable

    (57 )     (755 )     (208 )

Accrued expenses

    (149 )     356       191  

Accrued payroll and related items

    (197 )     629       (599 )

Interest payable

    (2,257 )     —         (1,594 )

Current portion of deferred revenue

    —         (3,121 )     (1,006 )

Other current liabilities

    2,122       (914 )     1,191  
                       

Net cash used in operating activities

    (43,784 )     (47,289 )     (60,854 )
                       

Cash flows from investing activities:

     

Acquisitions of property and equipment

    (188 )     (411 )     (8,017 )

Proceeds from sale of fixed assets

    29       180       3,605  

Payments for intangible assets

    —         (7 )     (10 )

Gross purchases of short-term investments

    (18,961 )     (29,967 )     (24,774 )

Gross sales of short-term investments

    7,123       4,930       13,333  

Gross maturities of short-term investments

    15,900       14,527       82,410  

Gross purchases of marketable securities

    (19,938 )     (11,710 )     (86,749 )

Gross sales of marketable securities

    21,389       52,925       56,412  

Gross maturities of marketable securities

    17,090       57,025       59,792  

Proceeds from sale of held for sale assets

    2,610       —         —    

Proceeds from sale of long-term marketable securities

    6,260       —         —    
                       

Net cash provided by investing activities

    31,314       87,492       96,002  
                       

Cash flows from financing activities:

     

Proceeds from exercise of stock options

    72       586       594  

Proceeds from issuance of common stock

    —         —         22,000  

Payments of stock issuance costs

    —         —         (1,153 )

Repayment of convertible debt

    (66,228 )     —         —    

Payment for extinguishment of debt

    (31,024 )     —         (61,540 )
                       

Net cash (used in) provided by financing activities

    (97,180 )     586       (40,099 )
                       

Cash flows from discontinued operations:

     

Net operating cash flows (used in) provided by discontinued operations

    (379 )     (7,870 )     9,770  

Net investing cash flows provided by (used in) discontinued operations

    67,819       8,480       (7,996 )

Net financing cash flows provided by discontinued operations

    23       494       86  
                       

Net cash provided by discontinued operations

    67,463       1,104       1,860  
                       

Plus decrease (increase) in cash and cash equivalents of discontinued operations, net of sale proceeds

    431       (1,104 )     (1,860 )

Net (decrease) increase in cash and cash equivalents

    (41,756 )     40,789       (4,951 )

Cash and cash equivalents, beginning of year

    58,486       17,697       22,648  
                       

Cash and cash equivalents, end of year

  $ 16,730     $ 58,486       $17,697  
                       

Supplemental cash flow information:

     

Interest paid

  $ 6,752     $ 8,487     $ 12,250  
                       

Income tax benefit payments received

  $ 407     $ 1,114     $ 523  
                       

Acquisition/construction of property and equipment, unpaid at end of period

  $ —       $ 9     $ 62  
                       

See accompanying notes to consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

1. Organization and Summary of Significant Accounting Policies

Organization—CuraGen Corporation (“CuraGen” or the “Company”), is a Connecticut-based biopharmaceutical development company dedicated to improving the lives of patients by developing novel therapeutics for the treatment of cancer.

In May 2007, the sale of 454 Life Sciences Corporation, our previously majority-owned subsidiary (“454”), to Roche Diagnostics Operations, Inc. (“RDO”), was completed. See Notes 12, 13 and 14 for further details.

All dollar amounts are shown in thousands, except share and per share data.

As shown in the accompanying financial statements, the Company has incurred significant recurring losses and negative cash flows from operations, and expects to continue to incur such losses and negative cash flows in the future. In the near future, the Company’s principal sources of liquidity will be its cash and investment balances, interest income, potential public securities offerings and/or private strategic-driven transactions. However, should these sources of liquidity not be available when needed, or should the Company’s actual cash requirements be greater than anticipated, the Company may be unable to meet the critical objective of its long-term business plan, which is to successfully develop and market pharmaceutical products, and it may be unable to continue operations. The Company’s failure to use sources of liquidity effectively could have a material adverse effect on its business, results of operations and financial condition.

The Company is currently evaluating several measures to strengthen its cash position and help meet its payment obligations, including plans to provide additional sources of liquidity in the future, which include but are not limited to strategic options with respect to collaborative or licensing arrangements for the development and testing of products under development, In addition, the Company continues to carefully manage the amounts and timing of its actual expenditures for its product development activities. As a result of these above actions, the Company believes that its existing cash balances will be sufficient to fund the Company’s operations into 2011. However, there can be no assurance that these measures will be successful to the extent necessary for the Company to remain current on its obligations, and therefore, it may be unable to meet the critical objective of its long-term business plan, which is to successfully develop and market pharmaceutical products, and it may be unable to continue operations.

Use of Estimates—The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates.

Cash and Investments—The Company considers investments readily convertible into cash, with an original maturity of three months or less to be cash equivalents. Investments with an original maturity greater than three months but less than one year are considered short-term investments. Investments with an original maturity equal to or greater than one year are designated as marketable securities. Both short-term investments and marketable securities are classified as available-for-sale securities, and are carried at fair value with the unrealized gains and losses reported in stockholders’ equity under the caption “Accumulated other comprehensive income (loss).”

The Company periodically reviews its investment portfolio based on criteria established in Financial Accounting Standards No. 115 “Accounting for Certain Investments in Debt and Equity Securities” to determine if there is an impairment that is other than temporary. In testing for impairment, the Company considers, among other factors, the length of time and the extent of a security’s unrealized loss, the financial condition and near

 

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CURAGEN CORPORATION AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

term prospects of the issuer, economic forecasts, market or industry trends and the Company’s ability and intent to hold securities to maturity. Interest on debt securities, amortization of premiums, accretion of discounts and realized investment gains and losses are included in interest income. The cost of securities sold is based on the specific identification method.

Property and Equipment—Property and equipment are recorded at cost. Additions, renewals and betterments that significantly extend the life of an asset are capitalized. Minor replacements, maintenance and repairs are charged to operations as incurred. Equipment is depreciated over the estimated useful lives of the related assets, ranging from three to five years, using the straight-line method. Leasehold improvements are amortized over the shorter of the estimated lives or the remaining terms of the leases, using the straight-line method. When assets are retired or otherwise disposed of, the assets and related accumulated depreciation or amortization are eliminated from the accounts and any resulting gain or loss is reflected in the consolidated statements of operations.

Impairment of Long-Lived Assets—The Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards No. 144, “Accounting for the Impairment or Disposal of Long Lived Assets,” which establishes a single accounting model for long lived assets to be held for use. The Company regularly evaluates the recoverability of the net carrying value of its property, and intangible assets, when an indicator of impairment is present by comparing the carrying values to the estimated future undiscounted cash flows. An impairment loss is recognized when the carrying value of the long-lived asset exceeds its fair value. The impairment write-down is the difference between the carrying amount and the fair value of these long-lived assets. A loss on impairment is recognized through a charge to earnings.

Licensing Fees—Licensing fees are paid for the right to market and sell certain technologies in our platform and licensing fees for various purposes. Perpetual licenses taken on potential therapeutic products for which there is no current indication as to whether or not there is a future commercial market for sale, are expensed when incurred. Licenses acquired for which there is a specific period of benefit are amortized by the Company over that period. The costs of non-perpetual licenses, which are included in Intangible and other assets, net, are amortized over the various lives of the licenses ranging from one to ten years.

Financing Costs—The Company includes deferred financing costs incurred in connection with the issuance of convertible subordinated debt in Intangible and other assets, net and amortizes these costs over the life of the debt. The amortization expense is included in interest expense. When debt is repurchased, the Company writes off the related unamortized deferred financing costs and nets the write off with any gain or loss recognized on the extinguishment of the debt.

Accumulated amortization was $1,341 and $3,796, respectively, as of December 31, 2007 and 2006. Amortization expense was $534, $865 and $1,049, respectively, for the years ended December 31, 2007, 2006 and 2005.

Patent Application Costs—The Company seeks patent protection on processes and products in various countries. All patent related costs are expensed to general and administrative expenses as incurred, as recoverability of such expenditures is uncertain.

Revenue Recognition—The Company recognizes revenue when all four criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products has occurred or services have been rendered; (3) the selling price is fixed or determinable; and (4) the collectibility is reasonably assured, in accordance with Securities and Exchange Commission Staff Accounting Bulletin No. 104, “Revenue Recognition,” which set forth guidelines for the timing of revenue recognition based upon factors such as passage of title, installation, payment and customer acceptance.

 

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Collaboration Revenue

During 2007, collaboration revenue was generated from the grant of exclusive worldwide rights from TopoTarget to a third party for a preclinical HDAC inhibitor, and the Company’s agreement with TopoTarget in which the Company receives 50% of initial payments received by TopoTarget from the third party. Under this agreement, the Company currently amortizes the $1,277 non-refundable payment received on a straight-line basis commencing in November 2006, the month the agreement was signed, through April 2022, the date the first original patent will expire in the United States. However, in the event that the third party terminates its license agreement with TopoTarget, all unrecognized revenue will be recognized upon termination. In January 2008, TopoTarget was informed by the third party that it was terminating the development of the preclinical compound in 2008 and as such the remaining unrecognized revenue as of December 31, 2007 of $1,174 is expected to be recognized in 2008.

Collaboration revenue during 2006 and 2005 was generated primarily under our Pharmacogenomics Agreement with Bayer (the “Bayer Agreement”). Payments under the terms of the Bayer agreement consisted of non-refundable fixed quarterly payments received in advance. The Bayer Agreement was completed in 2006. The non-refundable fixed quarterly payments received in advance under the Bayer Agreement related to the Company’s future performance of services and were deferred and recognized as revenue when the future performance occurred, based upon the satisfaction of defined metrics of completion, as outlined in the Bayer Agreement, which included proportional performance and project specific deliverables.

Accrued Expenses—The Company reviews open contracts and purchase orders, communicates with applicable personnel to identify services that have been performed on the Company’s behalf and estimates the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known. The Company also periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary.

Prepaid Expenses—The Company has established a method for monitoring and accounting for prepaid expenses. Prepaid expenses are those that arise when cash is disbursed and a portion of the associated benefit of the disbursement is for a future period. An asset is recorded on the books for the total invoice amount when paid and is amortized ratably over the coverage period.

Research and Development Expenses—Research and development costs are charged to research and development expenses as incurred. Such costs primarily include clinical trial related costs such as contractual services and manufacturing costs, salary and benefits, perpetual license fees and milestone payments, supplies and reagents, depreciation of lab equipment and allocated facility costs. Amounts relating to protein (or compound, or drug) manufacturing activities, for which the physical drug products will be utilized in research and development, are expensed as incurred, as there is no current indication that there is a future commercial market for sale of any successful drug development from these therapeutics.

Stock-Based Compensation— The Company adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”), effective January 1, 2006. SFAS 123R requires recognition of the fair value of stock-based compensation in net income (loss). Previously Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”) required only expanded disclosures of stock-based compensation arrangements with employees, and encouraged (but did not require) compensation cost to be measured based on the fair value of the equity instruments awarded. Companies were permitted to continue to apply Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued

 

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to Employees” (“APB 25”) for equity instruments awarded to employees, which recognized compensation cost based on the intrinsic value of the equity instruments awarded. The Company continued to apply APB 25 for purposes of its stock-based compensation awards to employees through December 31, 2005, and accordingly recorded no compensation expense for option grants unless the option grants had an exercise price less than the fair market value of the underlying stock at the date of grant.

The Company has one active stock-based compensation plan, the 2007 Stock Incentive Plan (“2007 Stock Plan”) and two inactive stock-based compensation plans, the 1997 Employee, Director and Consultant Stock Plan (“1997 Stock Plan”) and the 1993 Stock Option and Incentive Award Plan (“1993 Stock Plan”).

The Company transitioned to fair-value-based accounting for stock-based compensation under SFAS 123R using the modified version of the prospective application method (“modified prospective application method”). Under the modified prospective method, restatement of prior financial statements is not required; and, SFAS 123R applies to new awards and to awards modified, repurchased or cancelled on or after January 1, 2006. Additionally, compensation cost for the portion of awards that are outstanding as of January 1, 2006, for which the requisite service has not been rendered (generally referring to unvested awards), is recognized as the remaining requisite service is rendered after January 1, 2006.

Compensation cost for purposes of the pro forma disclosures required under SFAS 123 prior to January 1, 2006 was calculated on a straight-line basis over the requisite service period for each separately vesting portion of an award as if the awards were in substance, multiple awards, which resulted in an acceleration of compensation cost. Effective with the adoption of SFAS 123R, the Company records compensation cost for new awards on a straight-line basis over the requisite service period for the entire award.

In addition, the Company estimated forfeitures when calculating compensation expense for SFAS 123 pro forma disclosures, and adjusted the estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differed from such estimates. Changes in estimated forfeitures were recognized through a cumulative true-up adjustment in the period of change and also impacted the amount of compensation expense to be recognized in future periods. The Company continued to use this methodology after the adoption of SFAS 123R. With respect to accounting for the compensation expense related to restricted stock awards, the Company previously recognized forfeitures as they occurred. However, effective with the adoption of SFAS 123R, the Company now estimates forfeitures for purposes of calculating compensation expense related to restricted stock. The impact on previously reported compensation expense related to restricted stock where forfeitures were recognized as incurred was not material and was recorded in operating expenses.

Prior to the adoption of SFAS 123R, the Company used the Black-Scholes option valuation model to estimate the fair value of stock options granted to employees for purposes of SFAS 123 disclosure. Upon the adoption of SFAS 123R, the Company continues to use the Black-Scholes option valuation model for purposes of valuing all new awards and awards modified, repurchased or cancelled on or after January 1, 2006.

Historically, the Company used the following methods to determine the factors input into the Black-Scholes model: historical volatility is used to determine the expected stock price volatility factor; risk-free interest rates are based on the U.S. Treasury yield curve in effect at the time of grant, for the period corresponding to the approximate expected term of the options; and the expected term of the options has been calculated using CuraGen’s historical exercise patterns to estimate future exercise patterns. Effective with the adoption of SFAS 123R, the Company continues to utilize the same methodology for purposes of estimating the expected stock price volatility and the risk-free interest rates, however, for purposes of estimating the expected term, the Company uses the simplified approach as outlined in Staff Accounting Bulletin No. 107 (Topic 14) (“SAB 107”), whereby the expected term is equal to the average of the vesting term and the contractual term.

 

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For purposes of restricted stock grants, the grant date fair value is calculated as the fair market value of the stock on the date of grant less the purchase price of the restricted stock paid by the grantee, which is equal to the $.01 par value of the stock. The Company recognizes stock-based compensation expense for restricted stock grants over the requisite service period of the individual grants, which equals the vesting period. Generally, restricted stock grants to employees fully vest between two and three years from the grant date.

SFAS 123R requires the presentation of pro forma information for periods prior to the adoption as if the Company had accounted for all stock-based compensation under the fair value method. For purposes of pro forma disclosure, the estimated fair value of the options at the date of grant is amortized to expense over the requisite service period, which equals the vesting period. Employee stock-based compensation shown below includes the amortization of restricted stock compensation expense recorded in the consolidated statements of operations during the periods presented. The following table illustrates the effect on net loss from continuing operations and earnings per share as if the fair value recognition provisions had been applied to the Company’s employee stock-based compensation.

 

     Year Ended
December 31, 2005
 

Loss from continuing operations, as reported

   ($ 69,168 )

Employee stock-based compensation expense included in loss from continuing operations

     1,943  

Total employee stock-based compensation expense determined under the fair-value based method for all awards

     (4,815 )
        

Pro forma loss from continuing operations

   ($ 72,040 )
        

Basic and diluted loss per share from continuing operations:

  

As reported

   ($ 1.33 )

Pro forma

   ($ 1.39 )

Upon adoption of SFAS 123R, the Company recognizes the compensation expense associated with stock options granted to employees after December 31, 2005, and the unvested portion of previously granted employee stock option awards that were outstanding as of December 31, 2005, in the consolidated statements of operations. During the years ended December 31, 2007 and 2006, the Company recognized compensation expense in total operating expenses on the consolidated statements of operations with respect to employee stock options and restricted stock grants as follows:

 

     Year Ended
December 31, 2007
   Year Ended
December 31, 2006

Compensation expense with respect to employee stock options

   $ 1,167    $ 2,588

Compensation expense with respect to restricted stock grants

   $ 2,552    $ 2,615

Upon the adoption of SFAS 123R on January 1, 2006, the Company reversed the $3,016 balance in the unamortized stock-based compensation account to additional paid-in-capital in accordance with SFAS 123R. Due to the Company’s net loss from continuing operations position, no tax benefit was recorded during the period.

 

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For the years ended December 31, 2007 and 2006, the adoption of SFAS 123R had the effect of increasing the loss from continuing operations and basic and diluted loss per share from continuing operations, over amounts that would have been reported using the intrinsic value method under APB 25, as follows:

 

     Year Ended
December 31, 2007
   Year Ended
December 31, 2006

Increase in loss from continuing operations

   $ 1,167    $ 2,588

Increase in basic and diluted loss per share from continuing operations

   $ 0.02    $ 0.05

The fair value of options granted during the years ended December 31, 2007, 2006 and 2005 were estimated as of the grant date using the Black-Scholes option valuation model with the following weighted average assumptions:

 

     Year Ended December 31,
     2007    2006    2005

Expected stock price volatility

   66%    79%    81%

Expected risk-free interest rate

   4.80%    4.28%    3.54%

Expected option term in years

   6.25    6.25    4.60

Expected dividend yield

   0%    0%    0%

The approximate weighted-average grant date fair values using the Black-Scholes option valuation model of all stock options granted during the years ended December 31, 2007, 2006 and 2005 were $1.27, $2.78 and $3.50, respectively.

As of December 31, 2007 there was $1,581 of total unrecognized compensation expense related to unvested stock option grants under the 2007 Stock Plan and 1997 Stock Plan. This expense is expected to be recognized over a weighted-average period of 1.72 years.

As of December 31, 2007, there was $1,363 of total unrecognized compensation expense related to unvested restricted stock issuances under the 2007 Stock Plan and 1997 Stock Plan. This expense is expected to be recognized over a weighted-average period of 1.14 years.

As a result of the sale of 454 discussed in Note 13, 454’s operating results are being reported as discontinued operations for the period January 1, 2007 to May 25, 2007 and the years ended December 31, 2006 and 2005. During the period January 1, 2007 to May 25, 2007 and the year ended December 31, 2006, 454 recognized compensation expense of $2,706 and $678, respectively, with respect to employee stock option awards which is included in income (loss) from discontinued operations. During the year ended December 31, 2005, 454 recognized $586 for total employee stock-based compensation expense determined under the fair-value based method for all awards.

Comprehensive Income (Loss)—Statement of Financial Accounting Standards No. 130, “Reporting Comprehensive Income” (“SFAS 130”), requires reporting and displaying of comprehensive income (loss) and its components. In accordance with SFAS 130, the accumulated balance of other comprehensive income (loss) is disclosed as a separate component of stockholders’ equity and is comprised of unrealized gains and losses on short-term investments and marketable securities.

Income Taxes—Income taxes are provided for as required under Statement of Financial Accounting Standards No. 109, “Accounting for Income Taxes.” This statement requires the use of the asset and liability method in determining the tax effect of the “temporary differences” between the tax basis of assets and liabilities and their financial reporting amounts (see Note 15 for the adoption of FIN 48 “Accounting for Uncertainties in Income Taxes”).

 

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Income (Loss) Per Share—Basic income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, excluding unvested restricted stock. Diluted income (loss) per share reflects the potential dilution that could occur if options or other contracts to issue common stock were exercised or converted into common stock. Convertible subordinated debt, stock options granted but not yet exercised under CuraGen’s stock option plans and unvested restricted stock are anti-dilutive and therefore not considered for the diluted income (loss) per share calculations. Anti-dilutive potential common shares, consisting of convertible subordinated debt, outstanding stock options and unvested restricted stock were 13,371,135, 19,725,238, and 19,781,324 for the years ended December 31, 2007, 2006 and 2005, respectively.

Fair Value of Financial Instruments—Statement of Financial Accounting Standards No. 107, “Disclosures about Fair Value of Financial Instruments” requires the disclosure of fair value information for certain assets and liabilities, whether or not recorded in the balance sheets, for which it is practical to estimate that value. The Company has the following financial instruments: cash and cash equivalents, receivables, accounts payable, accrued expenses and certain other liabilities. The Company considers the carrying amount of these items to approximate fair value due to their short-term nature. In addition, the Company has short-term investments and marketable securities which are recorded at fair value (see Note 8). The Company also has convertible subordinated debt (see Note 7).

Recently Enacted Pronouncements—In September 2006, the FASB issued Statement SFAS No. 157, “Fair Value Measurements(“SFAS 157”). SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles, and expands disclosures about fair value measurements. On November 14, 2007, the FASB authorized its staff to draft a proposed FASB Staff Position that would partially defer the effective date of SFAS 157 for one year for non-financial assets and non-financial liabilities that are recognized or disclosed at fair value in the financial statements on a nonrecurring basis. SFAS No. 157 does not require any new fair value measurements; rather, it applies under other accounting pronouncements that require or permit fair value measurements. The provisions of SFAS 157 are to be applied prospectively as of the beginning of the fiscal year in which it is initially applied, with any transition adjustment recognized as a cumulative-effect adjustment to the opening balance of retained earnings. Notwithstanding the potential effective date deferral discussed above, SFAS 157 is effective for fiscal years beginning after November 15, 2007. The Company does not believe the adoption of SFAS 157 will have a material impact on its consolidated financial statements.

In June 2007, the FASB ratified the Emerging Issues Task Force (“EITF”) consensus on Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”). EITF 07-3 requires that nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. Such amounts should be recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided. EITF 07-3 is effective for fiscal years beginning after December 15, 2007, and interim periods within those fiscal years. The Company does not believe the adoption of EITF 07-3 will have a material impact on its consolidated financial statements.

In December 2007, the FASB ratified the EITF consensus on Issue No. 07-1, “Accounting for Collaborative Arrangements” (“EITF 07-1”). The EITF concluded that a collaborative arrangement is one in which the participants are actively involved and are exposed to significant risks and rewards that depend on the ultimate commercial success of the endeavor. Revenues and costs incurred with third parties in connection with collaborative arrangements would be presented gross or net based on the criteria in EITF 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent, and other accounting literature. Payments to or from

 

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collaborators would be evaluated and presented based on the nature of the arrangement and its terms, the nature of the entity’s business, and whether those payments are within the scope of other accounting literature EITF 07-1 is effective for fiscal years beginning after December 15, 2008. The Company does not believe the adoption of EITF 07-1 will have a material impact on its consolidated financial statements.

In December 2007, the SEC issued Staff Accounting Bulletin No. 110 (“SAB 110”). SAB 110 expresses the views of the staff regarding the use of a “simplified” method, as discussed in SAB No. 107 (“SAB 107”), in developing an estimate of expected term of “plain vanilla” share options in accordance with Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment. In particular, the staff indicated in SAB 107 that it will accept a company’s election to use the simplified method, regardless of whether the company has sufficient information to make more refined estimates of expected term. At the time SAB 107 was issued, the staff believed that more detailed external information about employee exercise behavior (e.g., employee exercise patterns by industry and/or other categories of companies) would, over time, become readily available to companies. Therefore, the staff stated in SAB 107 that it would not expect a company to use the simplified method for share option grants after December 31, 2007. The staff understands that such detailed information about employee exercise behavior may not be widely available by December 31, 2007. Accordingly, the staff will continue to accept, under certain circumstances, the use of the simplified method beyond December 31, 2007. The Company is in the process of evaluating the provisions of SAB 110 and does not believe the adoption of SAB 110 will have a material impact on its consolidated financial statements.

 

2. Property and Equipment

Property and equipment consisted of the following:

 

     December 31,
     2007    2006

Laboratory equipment

   $ 102    $ 12,426

Leasehold improvements

     863      12,143

Office equipment

     6,141      8,776
             

Total property and equipment

     7,106      33,345

Less accumulated depreciation and amortization

     6,627      21,130
             

Total property and equipment, net

   $ 479    $ 12,215
             

The decreases in property and equipment during 2007 were a result of write-offs related to the 2007 corporate restructurings, including the closure of the Company’s pilot manufacturing plant. Depreciation and amortization expense for property and equipment was $2,944, $6,273, and $5,408, for the years ended December 31, 2007, 2006 and 2005, respectively.

 

3. Leases

Operating Leases

The Company enters into lease agreements for its operations. Total rent expense under all operating leases for 2007, 2006 and 2005 was approximately $1,350, $1,281, and $2,084 respectively. The future minimum rental payments as of December 31, 2007 are $665, payable in 2008 and there are no further payments due thereafter.

 

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4. Major Collaborators and Geographical Information

The Company has entered into certain agreements with collaborators to provide products or services. There are no long-lived assets in countries other than the United States. Revenues from collaborators representing 10% or more of the Company’s total collaboration revenues are as follows:

 

     Year Ended December 31,  
     2007     2006     2005  
     $    %     $    %     $    %  

Company A

   $ 88    100 %     *    *       *    *  

Company B

     —      —       $ 2,110    92 %   $ 4,612    96 %

 

* less than 10%

Revenue by country, based on the location of each of the collaborators is as follows:

 

     Year Ended December 31,
     2007    2006    2005

United States

   $ —      $ 173    $ 179

Europe

     88      2,125      4,612

All others

     —        —        34
                    

Total

   $ 88    $ 2,298    $ 4,825
                    

 

5. Stockholders’ Equity

Authorized Capital Stock

The Company’s authorized capital stock consists of 250,000,000 shares of Common Stock, par value of $.01 per share (“Common Stock”), 5,000,000 shares of Preferred Stock, par value of $.01 per share and 3,000,000 shares of Non-Voting Common Stock. At December 31, 2007, the Company had reserved 7,215,646 shares of Common Stock for issuance pursuant to the 4% convertible subordinated notes due in 2011 (see Note 7). In addition, as of December 31, 2007 6,664,141 and 1,950,000 shares of Common Stock had been reserved for issuance pursuant to the 1997 Stock and the 2007 Stock Plan, respectively.

Common Stock

In August 2005, the Company issued 4,000,000 shares of its Common Stock at a public offering price of $5.50 per share. Net proceeds, after underwriting discounts and stock issuance costs, were $20,848. The net proceeds were used during August and September 2005 for repurchases of the Company’s outstanding convertible debt.

Stockholder Rights Plan

In March 2002, the Board of Directors of the Company adopted a stockholder rights plan and declared a dividend distribution of one preferred share purchase right for each outstanding share of the Company’s Common Stock. Each right entitles registered holders of the Company’s Common Stock to purchase one one-hundredth of a share of a new series of junior participating Preferred Stock, designated as “Series A Junior Participating Preferred Stock.” The rights generally will be exercisable only if a person (which term includes an entity or group) (i) acquires 20 percent or more of the Company’s Common Stock or (ii) announces a tender offer, the

 

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consummation of which would result in ownership by that person, entity or group of 20 percent or more of the common stock. Once exercisable, the stockholder rights plan allows the Company’s stockholders (other than the acquiror) to purchase Common Stock of the Company or of the acquiror at a substantial discount.

Stock Options

1993 Stock Plan

The Company’s 1993 Stock Plan was adopted by its Board of Directors and stockholders in December 1993 and subsequently amended by the Board of Directors in May 1997. The 1993 Stock Plan provided for the issuance of stock options and stock awards to officers, directors, advisors, employees, and affiliates of CuraGen. Of the 3,000,000 shares of Common Stock which were originally reserved for issuance under the 1993 Stock Plan, no options were outstanding as of December 31, 2007 and 1,576,504 stock options had been exercised under the 1993 Stock Plan as of December 31, 2007. Effective October 1997, upon a resolution by the Board of Directors, the Company will not grant any further options under the 1993 Stock Plan.

A summary of all stock option activity under the 1993 Stock Plan during the years ended December 31, 2005, 2006 and 2007 is as follows:

 

    Number
of Options
    Weighted
Average

Exercise Price
  Weighted
Average
Remaining
Contractual
Life (in years)
  Aggregate
Intrinsic Value

Outstanding January 1, 2005

  314,064     $ 2.52   1.63   $ 1,457

Granted

  —          

Exercised

  (91,200 )     1.56    

Canceled or lapsed

  —          
           

Outstanding December 31, 2005

  222,864       2.91   1.10     160

Granted

  —          

Exercised

  (128,400 )     1.83    

Canceled or lapsed

  (7,800 )     5.00    
           

Outstanding December 31, 2006

  86,664       4.33   0.63     40

Granted

  —          

Exercised

  —          

Canceled or lapsed

  (86,664 )     4.33    
           

Outstanding December 31, 2007

  —          
           

Exercisable December 31, 2005

  222,864       2.91   1.10     160
           

Exercisable December 31, 2006

  86,664       4.33   0.63     40
           

Exercisable December 31, 2007

  —         —     —       —  
           

The total intrinsic value of options exercised under the 1993 Stock Plan during the years ended December 31, 2006 and 2005 were $258 and $382 respectively. There were no options exercised under the 1993 Stock Plan during the year ended December 31, 2007.

1997 Stock Plan

The Company’s 1997 Stock Plan was approved by its Board of Directors in October 1997 and by its stockholders in January 1998. The 1997 Stock Plan provides for the issuance of stock options and stock grants

 

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(“Stock Rights”) to employees, directors and consultants of the Company. A total of 3,000,000 shares of Common Stock were originally reserved for issuance under the 1997 Stock Plan; in May 1999, upon approval of the stockholders, the amount reserved was increased to 7,000,000; and, in May 2003, upon approval of the stockholders, the amount reserved was increased to 10,500,000. The 1997 Stock Plan is administered by the Compensation Committee of the Board of Directors of the Company (“the Compensation Committee”). The Compensation Committee has the authority to administer the provisions of the 1997 Stock Plan and to determine the persons to whom Stock Rights will be granted, the number of shares to be covered by each Stock Right and the terms and conditions upon which a Stock Right may be granted. Effective May 2007, upon a resolution by the Board of Directors, the Company will not grant any further options under the 1997 Stock Plan. Generally, stock option grants to employees under the 1997 Stock Plan fully vest between four and five years from the grant date. As of December 31, 2007, the Company had 3,696,919 options outstanding under the 1997 Stock Plan and 1,656,262 stock options had been exercised under the 1997 Stock Plan.

A summary of all stock option activity under the 1997 Stock Plan during the years ended December 31, 2005, 2006 and 2007 is as follows:

 

    Number
of Options
    Weighted
Average

Exercise Price
  Weighted
Average
Remaining
Contractual
Life (in years)
  Aggregate
Intrinsic Value

Outstanding January 1, 2005

  5,045,687     $ 13.28   5.07   $ 6,593

Granted

  1,224,625       5.42    

Exercised

  (120,632 )     3.75    

Canceled or lapsed

  (966,369 )     13.80    
           

Outstanding December 31, 2005

  5,183,311       11.54   6.02     18

Granted

  1,673,070       3.86    

Exercised

  (112,649 )     3.22    

Canceled or lapsed

  (506,108 )     14.69    
           

Outstanding December 31, 2006

  6,237,624       9.37   6.32     2,166

Granted

  104,080       4.25    

Exercised

  (19,400 )     3.70    

Canceled or lapsed

  (2,625,385 )     13.67    
           

Outstanding December 31, 2007

  3,696,919       6.21   5.67     —  
           

Exercisable December 31, 2005

  3,286,775       14.02   4.75     18
           

Exercisable December 31, 2006

  3,559,479       12.53   4.78     900
           

Exercisable December 31, 2007

  2,605,910       6.84   4.81     —  
           

Shares Expected to Vest December 31, 2007

  574,906       4.68   7.69     —  
           

The total intrinsic value of options exercised under the 1997 Stock Plan during the years ended December 31, 2007, 2006 and 2005 were $10, $51 and $251, respectively.

 

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The following table presents weighted average price information about significant option groups under the 1997 Stock Plan exercisable at December 31, 2007:

 

Range of
Exercise Prices

   Number of
Options Exercisable
   Weighted Average
Remaining
Contractual
Life (in years)
   Weighted Average
Exercise Price

$       0-3.56

   715,945    6.02    $ 3.34

    3.85-4.80

   942,600    6.52      4.41

    5.09-6.10

   524,453    4.80      5.72

    8.48-8.71

   195,235    5.29      8.68

  15.83-22.50

   76,925    2.96      16.50

  24.94-31.66

   101,135    2.42      27.26

  41.13-53.03

   49,617    1.31      51.37
          
   2,605,910      
          

2007 Stock Plan

The 2007 Stock Plan was approved by the Company’s stockholders as of May 2, 2007. The 2007 Stock Plan provides for the issuance of stock options and stock grants to employees, directors and consultants of the Company. A total of 3,000,000 shares of common stock were reserved for issuance under the 2007 Stock Plan. The 2007 Stock Plan is administered by the Compensation Committee. The Compensation Committee has the authority to administer the provisions of the 2007 Stock Plan and to determine the persons to whom Stock Rights will be granted, the number of shares to be covered by each Stock Right and the terms and conditions upon which a Stock Right may be granted. Stock option grants to employees under the 2007 Stock Plan generally fully vest in four years. Of the 3,000,000 shares of Common Stock which are reserved for issuance under the 2007 Stock Plan, 717,548 options are outstanding under the 2007 Stock Plan and an additional 1,232,452 available for grant. As of December 31, 2007, no stock options had been exercised under the 2007 Stock Plan.

A summary of all stock option activity under the 2007 Stock Plan during the year ended December 31, 2007 is as follows:

 

     Number
of Options
    Weighted
Average
Exercise Price
   Weighted
Average
Remaining
Contractual
Life

(in years)
   Aggregate
Intrinsic Value

Outstanding May 2, 2007

   —            

Granted

   724,556     $ 1.59      

Exercised

   —         —        

Canceled or lapsed

   (7,008 )     1.97      
              

Outstanding December 31, 2007

   717,548       1.59    9.45    —  
              

Exercisable December 31, 2007

   107,500       2.73    7.94    —  
              

Shares Expected to Vest December 31, 2007

   577,034     $ 1.37    9.72    —  
              

There were no options exercised under the 2007 Stock Plan during the year ended December 31, 2007. At December 31, 2007 all 107,500 of exercisable options under the 2007 Stock Plan were exercisable at $2.73.

 

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Restricted Stock

1997 Stock Plan

From time to time, the Compensation Committee approves grants for shares of restricted stock. Pursuant to the provisions of the 1997 Stock Plan and 2007 Stock Plan, the purchase price of the restricted stock is equal to the par value of the Company’s Common Stock, and each grant of restricted stock is subject to certain repurchase rights of the Company. All repurchased shares are immediately retired upon resolutions by the Board of Directors.

A summary of all restricted stock activity under the 1997 Stock Plan during the years ended December 31, 2005, 2006 and 2007 is as follows:

 

     Number of
Shares of
Restricted Stock
    Weighted Average
Grant Date
Fair Value

Outstanding January 1, 2005

   450,895     $ 6.24

Granted

   772,875       4.06

Restrictions lapsed

   (97,250 )     6.36

Repurchased upon employee termination

   (83,200 )     6.13
        

Outstanding December 31, 2005

   1,043,320       4.63

Granted

   455,000       4.13

Restrictions lapsed

   (460,070 )     5.31

Repurchased upon employee termination

   (31,625 )     5.03
        

Outstanding December 31, 2006

   1,006,625       4.08

Granted

   487,020       4.39

Restrictions lapsed

   (760,395 )     4.09

Repurchased upon employee termination

   (42,230 )     4.51
        

Outstanding December 31, 2007

   691,020       4.25
        

The total fair value of restricted shares vested during the year ended December 31, 2007, 2006 and 2005 was $700, $1,823 and $548, respectively.

As of December 31, 2007, of the 691,020 of outstanding shares of restricted stock, 312,500 shares were issued in 2006 and will partially vest on the second and third anniversary of each grant date, with the lapsing of the repurchase rights. The remaining 378,520 outstanding shares of restricted stock which were issued in 2007 will partially vest on the first, second and third anniversary of each grant date.

2007 Stock Plan

A summary of all restricted stock activity under the 2007 Stock Plan during the year ended December 31, 2007 is as follows:

 

     Number of
Shares of
Restricted Stock
   Weighted Average
Grant Date
Fair Value

Outstanding May 2, 2007

   —        —  

Granted

   1,050,000    $ 1.28

Restrictions lapsed

   —        —  

Repurchased upon employee termination

   —        —  
       

Outstanding December 31, 2007

   1,050,000      1.28
       

 

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There were no restricted shares vested under the 2007 Stock Plan during the year ended December 31, 2007.

On May 25, 2007, the Compensation Committee of the Company approved the issuance of an aggregate of 975,000 shares of restricted common stock to five executive officers, which will vest and become free from forfeiture on December 31, 2008, if the closing price of the common stock on the Nasdaq Global Market has equaled or exceeded $5.00 per share over a period of 20 consecutive trading days for any period ending on or before December 31, 2008. In each case, the shares of common stock described above will only vest if the executive is an employee of the Company as of December 31, 2008. Therefore, pursuant to SFAS 123R, these restricted stock awards are deemed to contain a market condition which is reflected in the grant-date fair value of the awards, based on a valuation technique which considered all the possible outcomes of such market condition. Compensation cost is required to be recognized over the requisite service period for an award with a market condition provided that the requisite service is rendered, regardless of when, if ever, the market condition is satisfied. Accordingly, the Company will reverse previously recognized compensation cost for the above awards only if the requisite service is not rendered.

As of December 31, 2007, the remaining 75,000 outstanding shares of restricted stock which were issued in 2007 will vest on the first and second anniversary of each grant date, with the lapsing of the repurchase rights.

 

6. Income Taxes

The Company provides for income taxes using the asset and liability method. The difference between the income tax benefit and the amount that would be computed by applying the statutory Federal income tax rate to loss from continuing operations before income tax benefit is attributable to the following:

 

     Year Ended December 31,  
     2007     2006     2005  

Loss from continuing operations before income tax benefit

   $ (50,148 )   ($ 57,540 )   ($ 69,571 )
                        

Expected tax benefit at 35%

   $ 17,552     $ 20,139     $ 24,350  

Connecticut taxes, including research and development credits subject to carryforward, net of federal benefit

     622       3,426       4,259  

Federal research and development credits subject to carryforward

     1,472       1,458       1,495  

Increase in valuation allowance on deferred tax asset

     (19,327 )     (24,284 )     (29,699 )

Other items

     (134 )     (363 )     (2 )
                        

Total income tax benefit

   $ 185     $ 376     $ 403  
                        

The income tax benefits were recorded as a result of Connecticut legislation, which allows companies to obtain cash refunds from the State of Connecticut at a rate of 65% of their annual research and development expense credit, in exchange for forgoing carryforward of the research and development credit. For the years ended December 31, 2007 and 2006, the income tax benefit included adjustments resulting from the expiration of the State of Connecticut statute, as they relate to the Year 2003 and Year 2002 income tax benefit, respectively.

 

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Temporary differences and carryforwards that give rise to the deferred income tax assets are as follows:

 

     December 31,  
     2007     2006  

Net deferred income tax assets:

    

Net operating loss carryforwards

   $ 209,268     $ 206,777  

Research and development tax credit carryforwards

     29,492       27,778  

Stock options and restricted stock

     2,811       2,077  

Depreciation and amortization

     367       1,996  

Accumulated other comprehensive (income) loss

     (9 )     936  

Other

     586       745  
                
   $ 242,515     $ 240,309  

Valuation allowance

     (242,515 )     (240,309 )
                

Total

   $ —       $ —    
                

As the Company has no prior earnings history, a valuation allowance has been established to fully offset the Company’s deferred tax asset since it is more likely than not that the Company will not realize such assets. A tax benefit of approximately $30,866 related to stock options, will be credited to equity when the benefit is realized. For the year ended December 31, 2007, the increase in the valuation allowance was $2,206 which was comprised of an increased valuation in the amount of $19,327 for continuing operations, a decrease of $16,104 related to discontinued operations, and a decrease of $1,017 related to other comprehensive income and miscellaneous items. The increase in the valuation allowance was $26,971 and $28,964, for the years ended December 31, 2006 and 2005, respectively.

As of December 31, 2007, CuraGen has tax net operating loss carryforwards available to reduce future federal and Connecticut taxable income, research and development tax credit carryforwards available to offset future federal and Connecticut income taxes. Utilization of the net operating loss and tax credit carryforwards may be limited due to changes to our ownership, as defined within Section 382 of the Internal Revenue Code.

 

Net Operating Loss Carryforwards

Federal

   Expire In    Connecticut    Expire In
$532,514    2009 to 2028    $ 469,485    2021 to 2028
Research and Development Tax Credit Carryforwards

Federal

   Expire In    Connecticut    Expire In
$20,184    2009 to 2028    $ 14,233    2014 to 2023

 

7. Convertible Subordinated Debt

6% Convertible Subordinated Debentures Due 2007

In 2000, the Company completed an offering for $150,000 of 6% convertible subordinated debentures due February 2, 2007 and received net proceeds of approximately $145,600. During 2005 and 2004, the Company repurchased $83,772 of its 6% convertible subordinated debentures due in 2007, for total consideration of $81,540, plus accrued interest of $1,221 to the date of repurchase, and recorded a net gain of $1,472 in Gain on extinguishment of debt, which includes the write-off of the ratable portion of unamortized deferred financing costs relating to the repurchased debt.

 

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The debentures may be resold by the initial purchasers to qualified institutional buyers under Rule 144A of the Securities Act and to non-U.S. persons outside the United States under Regulation S under the Securities Act. The debentures are convertible at the election of the Company into Common Stock at any time prior to their maturity at a conversion price of $63.8275 per share, or a total of 1,037,609 shares of Common Stock issuable upon conversion of the notes as of December 31, 2006. On December 31, 2006, the market value of the debentures, based on quoted market prices, was approximately $66,063.

The Company pays cash interest on the debentures on February 2 and August 2 of each year. Related interest expense for the each of the years ended December 31, 2007, 2006 and 2005 was $331, $3,974 and $6,181, respectively.

On February 2, 2007, the Company repaid the remaining $66,228 balance outstanding on the 6% convertible subordinated debentures plus accrued interest of $1,986.

4% Convertible Subordinated Notes Due 2011

In 2004, the Company completed an offering of $110,000 of 4% convertible subordinated notes due February 15, 2011 and received net proceeds of approximately $106,200. During 2007, the Company repurchased a total of $40,110 of its 4% convertible subordinated debentures due February 2011, for total consideration of $31,024, plus accrued interest of $365 to the date of repurchase. As a result of the transaction, in 2007 the Company recorded a gain of $8,442 classified as Gain on extinguishment of debt on the consolidated statement of operations, which is net of the effect of the write-off of the ratable portion of unamortized deferred financing costs relating to the repurchased debt.

The remaining $69,890 of notes may be resold by the initial purchasers to qualified institutional buyers under Rule 144A of the Securities Act and to non-U.S. persons outside the United States under Regulation S under the Securities Act. The notes are convertible by the holders of the notes into the Company’s Common Stock at any time prior to the close of business on the maturity date of the notes, unless previously redeemed or repurchased, at a conversion rate of approximately $9.69 per share of Common Stock, or a total of 7,215,646 shares of Common Stock issuable upon conversion of the notes as of December 31, 2007.

In addition, during the period commencing February 18, 2009, to and including February 14, 2010, the Company has the right to redeem the notes at a redemption price equal to 101.143% of the principal amount of the notes plus accrued and unpaid interest, if any, to, but not including, the redemption date; and beginning on February 15, 2010, the Company has the right to redeem the notes at a redemption price equal to 100.571% of the principal amount of the notes plus accrued and unpaid interest, if any, to, but not including, the redemption date. The market value of the notes, based on quoted market prices, was approximately $50,146 as of December 31, 2007.

The Company pays interest in cash on the notes on February 15 and August 15 of each year. Related interest expense for the years ended December 31, 2007, 2006 and 2005 was $4,200, $4,400 and $4,400, respectively.

 

8. Available-for-Sale Securities

The Company purchases short-term investments and marketable securities consisting of debt securities, which have been designated as “available-for-sale” as required by Statement of Financial Accounting Standards No. 115, “Accounting for Certain Investments in Debt and Equity Securities.” Available-for-sale securities are carried at fair value with the unrealized gains and losses reported in stockholders’ equity under the caption

 

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Accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Interest on debt securities, amortization of premiums and accretion of discounts is included in interest income. The cost of securities sold is based on the specific identification method. At December 31, 2007 the Company has 9% of its cash, restricted cash and investment securities in mortgage-backed securities. All of these mortgage backed securities are sponsored by the United States Federal Government and are rated AAA by Moody’s. Additionally, the Company has 23% of its cash, restricted cash and investment securities in asset backed securities which consist of auto, credit card and equipment loans all with AAA ratings by Moody’s. The asset backed and mortgage backed securities have been priced by independent parties and trade at a net unrealized loss of $23 and the largest unrealized loss on any individual security is $34. The Company believes that any individual unrealized loss as of December 31, 2007 represents only a temporary impairment, and no adjustment of carrying values is warranted at this time.

The amortized cost, gross unrealized gains and losses and estimated fair value based on published closing prices of securities at December 31, 2007 and 2006, by contractual maturity, are shown below. Contractual maturities of mortgage backed and asset-backed securities are allocated in the tables based on the expected maturity date. In September 2007 the Company sold its equity investment in TopoTarget for proceeds of $6,260 and realized a gain of $973. In November 2007, the Company sold one of its investments to partially fund the repurchases of the 4% convertible debentures and realized a loss of $308.

 

     December 31, 2007
     Amortized
Cost
   Gross
Unrealized
Gains
   Gross
Unrealized
Losses
   Estimated
Fair Value

Available-for-sale securities:

           

Due in one year or less

   $ 53,072    $ 27    $ 111    $ 52,988

Due in one through three years

     30,665      135      74      30,726
                           

Total Available-for sale securities

   $ 83,736    $ 162    $ 185    $ 83,714
                           

The investment in TopoTarget was classified as an available-for-sale long-term marketable security and was included in Intangible and other assets, net, on the December 31, 2006 consolidated balance sheet at a fair value of $9,163 which included an unrealized gain of $3,875.

 

     December 31, 2006
     Amortized
Cost
   Gross
Unrealized
Gains
   Gross
Unrealized
Losses
   Estimated
Fair Value

Available-for-sale securities:

           

Due in one year or less

   $ 55,766    $ 3    $ 585    $ 55,184

Due in one through three years

     44,026      6      792      43,240

Due in three through five years

     7,642      —        159      7,483
                           

Total Available-for sale securities

   $ 107,434    $ 9    $ 1,536    $ 105,907
                           

For the year ended December 31, 2007 the Company realized gross gains of $1,033 and gross losses of $418 on securities sold. For the year ended December 31, 2006, the Company realized zero gross gains and gross losses of $288 on securities sold. For the year ended December 31, 2005, the Company realized gross gains of $4 and gross losses of $193.

 

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The following tables show the gross unrealized losses and fair values of the Company’s investments in individual securities that have been in a continuous unrealized loss position deemed to be temporary for less than 12 months, aggregated by contractual maturity:

 

     December 31, 2007
     Fair Value    Unrealized
Losses

Due in one year or less

   $ 8,054    $ 3
             

 

     December 31, 2006
     Fair Value    Unrealized
Losses

Due in one year or less

   $ 12,779    $ 3
             

The following table shows the gross unrealized losses and fair values of the Company’s investments in individual securities that have been in a continuous unrealized loss position deemed to be temporary for more than 12 months, aggregated by contractual maturity:

 

     December 31, 2007
     Fair Value    Unrealized
Losses

Due in one year or less

   $ 27,689    $ 108

Due in one through three years

     13,778      74
             
   $ 41,467    $ 182
             

 

     December 31, 2006
     Fair Value    Unrealized
Losses

Due in one year or less

   $ 35,680    $ 582

Due in one through three years

     35,970      792

Due in three through five years

     6,777      159
             
   $ 78,427    $ 1,533
             

 

9. Restructuring and Related Charges

In June 2003, CuraGen announced a restructuring plan intended to focus resources on continuing to advance its pipeline of protein, antibody, and small molecule therapeutics into preclinical and clinical development. In connection with the June 2003 restructuring plan, a charge of $2,888 was recorded in the second quarter of 2003, including $1,742 related to employee separation costs, $1,046 of operating lease obligations and a $100 asset impairment charge. The cash requirements under the June 2003 restructuring plan were $2,681, of which all were paid prior to December 31, 2007.

In November 2005, CuraGen underwent a corporate restructuring to focus on advancing its therapeutic pipeline through clinical development. In connection with the November 2005 restructuring plan, a charge of $1,537 was recorded in the fourth quarter of 2005, including $1,396 of operating lease obligations and $141 of asset impairment costs. The cash requirements under the November 2005 restructuring plan were $1,396, of which all were paid prior to December 31, 2007.

 

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During June and September 2007, the Company underwent corporate restructurings to reduce operating costs and to focus resources on the advancement of its therapeutic pipeline through clinical development, resulting in a restructuring charge of $11,274. This amount includes an asset impairment charge of $6,322 (associated with the closure of its pilot manufacturing plant, also known as the Biopharmaceutical Sciences Process facility, or BPS, on July 27, 2007), $4,408 related to employee separation costs paid or payable in cash, $286 of non-cash employee separation costs and $258 of other asset write-offs.

The following table details the charges, cash payments and balance of the restructuring reserve as of and for the year ended December 31, 2007:

 

     Charge    Cash
Payments
in 2007
   Reserve at
December 31,
2007

Employee separation costs:

        

Cash

   $4,408    $1,617    $2,791
            

Non-cash

   286      
          

Total employee separation costs

   4,694      
          

Impairment of assets:

        

Asset impairment charge

   6,580      
          

Total restructuring charge

   $11,274      
          

 

10. TopoTarget A/S Collaboration and License Agreement

In June 2004, the Company and TopoTarget entered into a license and collaboration agreement to develop and commercialize belinostat, a novel histone deacetylase (“HDAC”) inhibitor for the treatment of solid and hematological cancers. Under the terms of the agreement, the Company acquired exclusive rights to develop and commercialize belinostat in North America, Asia and all other markets excluding Europe. TopoTarget retained commercialization rights in Europe.

Under the financial terms of the agreement, during 2004, the Company made a $5,000 investment in TopoTarget, which was recorded as a Convertible Loan Receivable and was included in Intangible and other assets, net on the December 31, 2004 balance sheet. The loan was due May 10, 2009, unless TopoTarget completed an Initial Public Offering on the Copenhagen Stock Exchange (“IPO”), at which time the loan must convert into TopoTarget common stock at the IPO subscription price. The loan began accruing interest quarterly on June 30, 2004, at an annual rate of 6% and such interest was added to the principal amount of the loan on a quarterly basis if not paid by TopoTarget.

On June 10, 2005, TopoTarget completed an IPO of 11,500,000 shares of common stock at a per share price of DKK 22,50 ($3.698 USD). Simultaneously, on June 10, 2005, the Convertible Loan Receivable in the amount of $5,288 (including accrued interest) was automatically converted into 1,429,687 shares of TopoTarget common stock, providing the Company with an approximate 3.58% ownership in TopoTarget at fair value. During 2007, the Company sold its Investment in TopoTarget for proceeds of $6,260 and realized a gain of $973.

In November 2006, the Company granted exclusive worldwide rights to a third party to develop, manufacture, and commercialize PXD118490, a preclinical HDAC inhibitor, for the treatment of psoriasis and other dermatological disorders. Under the terms of the agreement between TopoTarget and the third party, TopoTarget received during 2006 initial payments totaling 2,000 euros (approximately $2,600). Under the terms

 

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of an existing agreement between TopoTarget and the Company, the Company will receive 50% of all payments received by TopoTarget under the licensing agreement between TopoTarget and the third party. In January 2008, TopoTarget was informed by the third party that it will be terminating the development of the preclinical compound pursuant to which the Company received the collaboration revenue.

 

11. Seattle Genetics, Inc. Collaboration Agreement

In June 2004, the Company and Seattle Genetics, Inc. (“Seattle Genetics”) entered into a collaboration agreement to license Seattle Genetics’ proprietary antibody-drug conjugate (“ADC”) technology for use with the Company’s proprietary antibodies for the potential treatment of cancer. The Company paid an upfront fee of $2,000 for access to the ADC technology for use in one of its proprietary antibody programs. In February 2005, the Company also exercised its option to access Seattle Genetics’ ADC technology for use with a second antibody program in exchange for a $1,000 payment. In June 2006, the Company paid a milestone payment for the enrollment of the first patient in the first Phase I clinical trial of CR011-vcMMAE for the treatment of metastatic melanoma. All payments discussed above were fully expensed at the time of payment, pursuant to the Company’s accounting policy for such fees.

The Company is responsible for research, product development, manufacturing and commercialization of all products under the collaboration, and will pay maintenance and material supply fees as well as research support payments for any assistance provided by Seattle Genetics in developing ADC products.

 

12. Segment Reporting

As of December 31, 2006, the Company had two reportable segments, CuraGen and 454. As of March 31, 2007, 454 was classified as a discontinued operation as a result of the Merger Agreement with Roche Holdings, Inc. and 13 Acquisitions, Inc., an indirect wholly-owned subsidiary of Roche Holdings, Inc. (the “Merger Agreement”). Accordingly, as of December 31, 2007, the Company operated as one segment excluding discontinued operations (see Note 14).

 

13. 454 Life Sciences/Roche Holdings, Inc. Merger

On March 28, 2007, 454 entered into the Merger Agreement. Roche Holdings, Inc. subsequently assigned the Merger Agreement to its affiliate RDO. Roche Holdings, Inc. and RDO are affiliates of Roche, a global research-based healthcare company. Under the Merger Agreement, 13 Acquisitions, Inc. was merged with and into 454 (the “Merger”), with 454 continuing after the Merger as the surviving corporation and an indirect wholly-owned subsidiary of Roche Holdings, Inc.

Under the terms of the Merger Agreement, upon the closing of the sale of 454 to RDO on May 25, 2007, the purchase price before transaction costs was $152,019, of which RDO paid $140,000 in cash and $12,019 was received from the exercise of 454 stock options following the signing of the Merger Agreement and prior to the closing of the sale. Of the $140,000 received from RDO, $25,000 was placed in escrow for a period of 15 months, or until August 25, 2008, to provide for certain post-closing adjustments based on 454’s net working capital and net debt on May 25, 2007, and to secure the indemnification rights of RDO and its affiliates. The Company believes it will receive its share of the escrow fund, or $14,129, after expiration of the escrow term on August 25, 2008 and has included such amount in the determination of the gain on sale in accordance with Statement of Financial Accounting Standards No. 141, “Business Combinations”. Interest earned on the Company’s portion of restricted cash is being accrued on a quarterly basis and accordingly, $404 was accrued in 2007. As a result, $14,533 is classified as restricted cash and is included in current assets on the accompanying consolidated Balance Sheets, due to its short-term nature as of December 31, 2007.

 

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Following the closing, as required by the Merger Agreement, 454 prepared a closing balance sheet and calculated its net working capital and net debt as of the closing date. Based upon the closing balance sheet and net working capital and net debt calculations, RDO paid an additional $1,030 in merger consideration to 454 shareholders. In July 2007, CuraGen received $582, its portion of this additional amount, which was included in the calculation of the gain on sale of subsidiary reported in the second quarter of 2007.

The Company’s portion of the purchase price after transaction costs, including the net working capital and net debt adjustment and the amount expected from the escrow, was $82,023.

 

14. Discontinued Operations

The sale of 454 on May 25, 2007 has been accounted for in accordance with Statement of Financial Accounting Standards No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”, (“SFAS 144”), and 454’s operating results are reported as a discontinued operation for the period January 1, 2007 to May 25, 2007 and the years ended December 31, 2005 and 2006.

The following table summarizes the financial information for the discontinued operations of 454 for the period January 1, 2007 to May 25, 2007 and the years ended December 31, 2005 and 2006:

 

     January 1
to
May 25, 2007
    Year ended
December 31,
2006
    Year ended
December 31,
2005
 

Revenue:

      

Product revenue

   $ 14,210     $ 19,417     $ 12,558  

Sequencing service revenue

     3,825       10,025       2,623  

Collaboration revenue

     1,350       1,500       —    

Grant revenue

     444       2,296       2,826  

Milestone revenue

     3,707       4,050       950  
                        

Total revenue

   $ 23,536     $ 37,288     $ 18,957  
                        

Operating Expenses:

      

Cost of product revenue

   $ 9,015     $ 11,586     $ 4,688  

Cost of sequencing service revenue

     2,407       4,334       1,047  

Grant research expenses

     425       2,095       2,201  

Research and development expenses

     7,908       14,535       10,950  

General and administrative expenses

     7,075       8,810       6,461  
                        

Total operating expenses

   $ 26,830     $ 41,360     $ 25,347  
                        

Loss from discontinued operations before minority interest

   ($ 3,053 )   ($ 3,655 )   ($ 6,019 )

Minority interest in loss of discontinued consolidated subsidiary

     62       980       1,943  

Gain on sale of subsidiary

     78,352       —         —    
                        

Income (loss) from discontinued operations

   $ 75,361     ($ 2,675 )   ($ 4,076 )
                        

During the third quarter of 2006, the cumulative losses applicable to the minority interest in subsidiary exceeded the minority interest in the equity capital of 454, therefore, the majority of losses applicable to the minority interest from the third quarter of 2006 through the closing of the sale of 454 in the second quarter of 2007 were charged to CuraGen.

 

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CURAGEN CORPORATION AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

The following tables set forth the components of 454’s assets and liabilities classified as held for sale on the consolidated Balance Sheets at December 31, 2006 (in thousands):

 

     December 31,
2006

Cash and cash equivalents

   $ 4,164

Short-term investments

     1,507

Marketable securities

     90

Accounts, grants and royalty receivable

     10,850

Inventory

     9,855

Property and equipment, net

     3,945

Licensing fees, net

     3,281

Other assets

     1,189
      

Assets held for sale

   $ 34,881
      
     December 31,
2006

Accounts payable

   $ 841

Accrued expenses

     1,458

Deferred revenue

     27,539

Other liabilities

     897
      

Liabilities held for sale

   $ 30,735
      

 

15. Accounting for Uncertainty in Income Taxes

In July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109 “Accounting for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on derecognition, classification, interest and penalties, accounting for taxes in interim periods and disclosure requirements. The provisions of FIN 48 are to be applied to all tax positions upon initial adoption of this standard. Only tax positions that meet the more-likely-than-not recognition threshold at the effective date may be recognized or continue to be recognized upon adoption of FIN 48. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards. The cumulative effect of applying the provisions of FIN 48 should be reported as an adjustment to the opening balance of retained earnings for that fiscal year. The provisions of FIN 48 are effective for fiscal years beginning after December 15, 2006. For the Company, this interpretation was effective beginning January 1, 2007.

As a result of the implementation of FIN 48, the Company recorded no adjustments in its unrecognized income tax benefits. The following table depicts the components of the Company’s unrecognized income tax benefits as of December 31, 2007.

 

Liability for Unrecognized Tax Benefits

  

Unrecognized tax benefits, January 1, 2007

   $ 809

Gross increases—tax positions in prior periods

     98

Gross decreases—tax positions in prior periods

     —  

Gross increases—current period tax positions

     —  

Settlements

     —  

Lapse of statute of limitations

     —  
      

Unrecognized tax benefits, December 31, 2007

   $ 907
      

 

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CURAGEN CORPORATION AND SUBSIDIARY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

 

If recognized, all of the unrecognized tax benefits would be recorded as a benefit to income tax expense on the consolidated statements of operations. The Company does not currently anticipate significant changes in the amount of unrecognized income tax benefits over the next year. To the extent penalties and interest would be assessed on any underpayment of income tax, the Company’s policy is that such amounts would be accrued and classified as a component of income tax expense in the financial statements. To date the Company has not accrued any interest or penalties as they would be immaterial.

As a result of net operating loss carryforwards, the Company’s federal tax returns since 1992 remain open to examination with no years currently under examination by the Internal Revenue Service, and the Company’s Connecticut tax returns remain open to examination for all years since 2000 with no years currently under examination by the Department of Revenue Services.

 

16. Summary of Selected Quarterly Financial Data (Unaudited)

 

     Quarter Ended  
     March 31     June 30     Sept. 30     Dec. 31  

2007:

        

Total revenue

   $ 22     $ 22     $ 22     $ 22  

Total operating expenses

     15,515       21,432       11,699       11,062  

Loss from continuing operations

     (15,908 )     (21,585 )     (9,897 )     (2,572 )

Net (loss) income

     (17,047 )     54,913       (9,897 )     (2,571 )

Basic and diluted net (loss) income per share

     ($0.31)     $ 0.98       ($0.18)       ($0.04)  

2006:

        

Total revenue

   $ 1,418     $ 866     $ —       $ 14  

Total operating expenses

     14,773       14,404       14,248       14,232  

Loss from continuing operations

     (13,809 )     (13,950 )     (14,788 )     (14,617 )

Net loss

     (13,864 )     (14,299 )     (15,880 )     (15,796 )

Basic and diluted net loss per share

     ($0.25)       ($0.26)       ($0.29)       ($0.29)  

The sale of 454 on May 25, 2007 has been accounted for in accordance with SFAS 144. In addition, 454’s operating results are reported as a discontinued operation for the year ended December 31, 2006, and for the period January 1, 2007 to May 25, 2007.

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of CuraGen Corporation

Branford, Connecticut

We have audited the accompanying consolidated balance sheets of CuraGen Corporation and subsidiary (the “Company”) as of December 31, 2007 and 2006, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2007. We also have audited the Company’s internal control over financial reporting as of December 31, 2007, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company’s management is responsible for these financial statements, 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 Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on these financial statements and an opinion on the Company’s internal control over financial reporting 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 and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included 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. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

A company’s internal control over financial reporting is a process designed by, or under the supervision of, the company’s principal executive and principal financial officers, or persons performing similar functions, and effected by the company’s board of directors, management, and other personnel 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 company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) 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 (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of CuraGen Corporation and subsidiary as of December 31, 2007 and 2006, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2007, in conformity with accounting principles generally accepted in the United States of America. Also, in our

 

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opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2007, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.

As discussed in Notes 1 and 15 to the consolidated financial statements, effective January 1, 2007, the Company adopted FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 and effective January 1, 2006, the Company adopted the fair value method of accounting for stock-based compensation as required by Statement of Financial Accounting Standards No. 123(R), Share-Based Payment.

 

 

/s/ Deloitte & Touche LLP

Hartford, Connecticut

March 11, 2008

 

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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Not applicable.

 

Item 9A. Controls and Procedures

 

1. Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2007. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our chief executive officer and chief financial officer concluded that, as of December 31, 2007, our disclosure controls and procedures were effective at the reasonable assurance level.

 

2. Internal Controls over Financial Reporting

 

  (a) Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, 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 and includes those policies and procedures that:

 

   

pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;

 

   

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

 

   

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s 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. 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.

Our management, with the supervision and participation of the chief executive officer and chief financial officer, assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2007. In making this assessment, management used the criteria set forth by the Committee of Sponsoring

 

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Organizations of the Treadway Commission (COSO) in “Internal Control—Integrated Framework.”Based on this assessment, management has concluded that, as of December 31, 2007, our internal control over financial reporting is effective based on those criteria.

 

  (b) Deloitte & Touche LLP has issued an attestation report on our internal control over financial reporting, which report is included in the “Report of Independent Registered Public Accounting Firm” included in Item 8 of this Annual Report on Form 10-K.

 

  (c) Changes in Internal Control over Financial Reporting

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended as of December 31, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Item 9B. Other Information

Not applicable.

 

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PART III

 

Item 10. Directors, Executive Officers and Corporate Governance

The information relating to our directors, nominees for election as directors, executive officers, audit committee, code of ethics and corporate code of conduct and changes to the procedures by which our security holders may recommend nominees to our board of directors that appears under the headings “Proposal One—Election of Directors”, “Executive Officers”, “Corporate Governance”, “Code of Ethics and Corporate Code of Conduct” and “Section 16(a) Beneficial Ownership Reporting Compliance” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 11. Executive Compensation

The discussion under the headings “Executive Compensation”, “Director Compensation”, “Compensation Discussion and Analysis”, “Compensation Committee Report” and “Compensation Committee Interlocks and Insider Participation” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The discussion under the heading “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 13. Certain Relationships and Related Transactions, and Director Independence

The discussion under the headings “Certain Relationships and Related Transactions” and “Corporate Governance” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 14. Principal Accountant Fees and Services

The discussion under the heading “Principal Accountant Fees and Services” in our definitive proxy statement for our 2008 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

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PART IV

 

Item 15. Exhibits and Financial Statement Schedules

ITEM 15 (a)(1)        Financial Statements

The following Financial Statements are included in Item 8:

Consolidated Balance Sheets as of December 31, 2007 and 2006

Consolidated Statements of Operations for the Years Ended December 31, 2007, 2006 and 2005

Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2007, 2006 and 2005

Consolidated Statements of Cash Flows for the Years Ended December 31, 2007, 2006 and 2005

Notes to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm

ITEM 15 (a)(2)        Financial Statement Schedules

All schedules are omitted because they are not applicable or the required information is shown in the financial statements or the notes thereto.

ITEM 15 (a)(3)        Exhibits

Reference is made to the index to Exhibits on page 84.

 

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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.

 

Dated: March 11, 2008     CURAGEN CORPORATION
      By:   /s/    SEAN A. CASSIDY        
       

Sean A. Cassidy

Vice President and
Chief Financial Officer

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.

 

Signature

  

Title

/s/    TIMOTHY M. SHANNON, M.D.        

   President and Chief Executive Officer
Timothy M. Shannon, M.D.    (principal executive officer of the registrant)
/s/    SEAN A. CASSIDY            Vice President and Chief Financial Officer
Sean A. Cassidy    (principal financial and accounting officer of the registrant)
      Director
Frank M. Armstrong, M.D.    Dated: March     , 2008
/s/    VINCENT T. DEVITA, JR., M.D.            Director
Vincent T. DeVita, Jr, M.D.    Dated: March 6, 2008
/s/    JOHN H. FORSGREN            Director
John H. Forsgren    Dated: March 10, 2008
/s/    JAMES J. NOBLE, M.A., F.C.A.            Director
James J. Noble, M.A., F.C.A.    Dated: March 6, 2008
/s/    ROBERT E. PATRICELLI, J.D.            Director
Robert E. Patricelli, J.D.    Dated: March 4, 2008
/s/    PATRICK J. ZENNER            Director
Patrick J. Zenner    Dated: March 3, 2008

 

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EXHIBIT INDEX

 

         

Incorporated by Reference to

    

Exhibit

No.

  

Description

  

Form and
SEC File No.

  

SEC

Filing Date

   Exhibit
No.
   Filed with
this 10-K
   Plan of Acquisition, Reorganization, Arrangement, Liquidation or Succession
2.1    Agreement and Plan of Merger, dated March 28, 2007, by and among 454 Life Sciences Corporation, Roche Holdings, Inc. and 13 Acquisitions, Inc.   

8-K

(000-23223)

   4-2-2007    99.1   
   Certificate of Incorporation and By-Laws
3.1    Restated Certificate of Incorporation of the Registrant   

S-1/A

(333-38051)

   3-13-1998    3.3   
3.2    Certificate of Amendment of the Restated Certificate of Incorporation of the Registrant   

10-Q

(000-23223)

   8-12-2003    3.2   
3.3    Certificate of Designation, Series A Junior Participating Preferred Stock of the Registrant   

10-K

(000-23223)

   3-26-2003    3.3   
3.4    Amended and Restated By-Laws of the Registrant   

10-Q

(000-23223)

   11-4-2005    4.1   
   Instruments Defining the Rights of Security Holders
4.1    Form of Common Stock Certificate of the Registrant   

S-1/A

(333-38051)

   3-13-1998    4.2   
4.2    Indenture, dated February 17, 2004 between the Registrant and The Bank of New York, as trustee   

10-K

(000-23223)

   3-11-2004    4.5   
4.3    Stockholder Rights Agreement, dated March 27, 2002, by and between the Registrant and American Stock Transfer and Trust Company   

10-K

(000-23223)

   4-1-2002    4.4   
   Material Contracts—Equity Compensation Plans and Related Agreements
10.1#    1993 Stock Option and Incentive Award Plan of the Registrant, as amended and restated through May 12, 1997   

10-K

(000-23223)

   3-14-2005    10.1   
10.2#    1997 Employee, Director and Consultant Stock Plan of the Registrant, as amended and restated through January 26, 2005   

8-K

(000-23223)

   2-7-2005    99.2   
10.3#    2007 Stock Incentive Plan of the Registrant   

10-Q

(000-23223)

   8-9-2007    10.1   
10.4#    Form of Non-Qualified Stock Option Agreement (Pre May 3, 2006) (Standard) under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

8-K

(000-23223)

   2-7-2005    99.3   
10.5#      Form of Non-Qualified Stock Option Agreement (Pre May 3, 2006) (Director & Officer) under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

8-K

(000-23223)

   2-7-2005    99.4   

 

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Table of Contents
         

Incorporated by Reference to

    

Exhibit

No.

  

Description

  

Form and
SEC File No.

  

SEC

Filing Date

   Exhibit
No.
   Filed with
this 10-K
10.6#      Form of Non-Qualified Stock Option Agreement (Effective May 3, 2006) (Standard) under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

10-Q

(000-23223)

   8-9-2006    10.5   
10.7#      Form of Non-Qualified Stock Option Agreement (Effective May 3, 2006) (Director & Officer) under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

10-Q

(000-23223)

   8-9-2006    10.6   
10.8#      Form of Nonstatutory Stock Option Agreement (Effective May 2, 2007) (Standard) under the 2007 Stock Incentive Plan of the Registrant   

10-Q

(000-23223)

   8-9-2007    10.2   
10.9#      Form of Nonstatutory Stock Option Agreement (Effective January 24, 2008) under the 2007 Stock Incentive Plan of the Registrant             *
10.10#    Nonstatutory Stock Option Agreement, dated September 25, 2007, under the 2007 Stock Incentive Plan of the Registrant between the Registrant and Timothy M. Shannon, M.D.   

10-Q

(000-23223)

   11-9-2007    10.3   
10.11#    Form of Incentive Stock Option Agreement under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

8-K

(000-23223)

   2-7-2005    99.5   
10.12#    Form of Incentive Stock Option Agreement (Effective May 2, 2007) under the 2007 Stock Incentive Plan of the Registrant   

10-Q

(000-23223)

   8-9-2007    10.3   
10.13#    Form of Restricted Stock Agreement under the 1997 Employee, Director and Consultant Stock Plan of the Registrant   

8-K

(000-23223)

   2-7-2005    99.6   
10.14#    Form of Restricted Stock Agreement under the 2007 Stock Incentive Plan of the Registrant   

10-Q

(000-23223)

   8-9-2007    10.3   
10.15#    Form of Restricted Stock Agreement under the 2007 Stock Incentive Plan of the Registrant for Restricted Stock Awards granted on May 25, 2007 to each of Frank M. Armstrong, Paul M. Finigan, Timothy M. Shannon, Elizabeth A. Whayland and David M. Wurzer   

10-Q

(000-23223)

   11-9-2007    10.6   
10.16#    Executive Incentive Plan of the Registrant   

8-K

(000-23223)

   2-7-2005    99.1   
10.17#    Revised Board of Directors Compensation Policy of the Registrant, approved March 29, 2006   

10-Q

(000-23223)

   5-10-2006    10.6   
10.18#    Executive Officer Compensation Summary             *
10.19#    Non-Employee Director Compensation Summary             *

 

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Table of Contents
         

Incorporated by Reference to

    

Exhibit

No.

  

Description

  

Form and
SEC File No.

  

SEC

Filing Date

   Exhibit
No.
   Filed with
this 10-K
Material Contracts—Stock Purchase, Registration Rights and Underwriting Agreements

10.20  

   Purchase Agreement, dated February 10, 2004, between the Registrant and Bear, Stearns & Co., Inc.   

10-K

(000-23223)

   3-11-2004    10.30   

10.21  

   Registration Rights Agreement, dated February 17, 2004 among the Registrant and Bear, Stearns & Co. Inc., as the initial purchaser   

10-K

(000-23223)

   3-11-2004    10.31   

10.22  

   Underwriting Agreement, dated August 9, 2005, by and between the Registrant and Bear, Stearns & Co., Inc.   

8-K

(000-23223)

   8-10-2005    1.1   

10.23  

   Stock Purchase Agreement, dated January 12, 2001, by and between Bayer AG and the Registrant   

10-K

(000-23223)

   3-28-2001    10.26   

10.24#

   Indemnity Agreement, dated August 1, 2007, between 454 Life Sciences Corporation and the Registrant   

10-Q

(000-23223)

   11-9-2007    10.5   
   Material Contracts—Leases            

10.25  

   Lease, as amended and restated, through July 1, 2005, (Branford) by and between T.K.J. Associates, LLC and the Registrant   

10-Q

(000-23223)

   11-4-2005    10.3   

10.26  

   Lease Agreement, dated December 23, 1996 (New Haven) by and between the Registrant and Fusco Harbour Associates, LLC   

S-1

(333-38051)

   10-16-1997    10.1   

10.27  

   Memorandum of Lease for Lease Agreement, dated December 23, 1996 and amended on October 27, 1997 and August 31, 1998 (New Haven) between the Registrant and Fusco Harbour Associates, LLC   

10-K

(000-23223)

   3-26-1999    10.1   

10.28

   Third, Fourth, Fifth and Sixth Amendments to Lease Agreements, dated January 1, 2001, June 5, 2001, March 12, 2002 and May 8, 2002, respectively, (New Haven) by and between the Registrant and Fusco Harbour Associates, LLC   

10-K

(000-23223)

   3-26-2003    10.1   

10.29#

   Assignment and Assumption of Lease with Landlord’s Consent and Release, dated August 1, 2007, between ZFI Group, LLC, 454 Life Sciences Corporation and the Registrant   

10-Q

(000-23223)

   11-9-2007    10.4   
   Material Contracts—Collaboration, Supply, License, Distribution Agreements   

10.30†

   Metabolic Disorder Collaboration Agreement, dated January 12, 2001, by and between Bayer Corporation and the Registrant   

10-K

(000-23223)

   3-28-2001    10.24   

10.31†

   Amendment, dated November 11, 2005, to Metabolic Disorder Collaboration Agreement, dated January 12, 2001, by and between Bayer Corporation and the Registrant   

10-K

(000-23223)

   3-14-2006    10.30   

 

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Incorporated by Reference to

    

Exhibit

No.

  

Description

  

Form and
SEC File No.

  

SEC

Filing Date

   Exhibit
No.
   Filed with
this 10-K
  10.32†    Amendment, dated May 30, 2006, to Metabolic Disorder Collaboration Agreement, dated January 12, 2001, by and between Bayer Corporation and the Registrant   

10-Q

(000-23223)

   8-9-2006    10.1   
  10.33†    Pharmacogenomics Agreement, dated January 12, 2001, by and between the Registrant and Bayer AG   

10-K

(000-23223)

   3-28-2001    10.25   
  10.34†    Amendment dated December 19, 2003 to Pharmacogenomics Agreement, dated January 12, 2001, by and between the Registrant and Bayer AG   

10-K

(000-23223)

   3-11-2004    10.12   
  10.35†    Second Restated Collaboration Agreement, dated April 12, 2004 and amended October 19, 2004, between Abgenix, Inc. and the Registrant   

10-Q

(000-23223)

   8-6-2004    10.1   
  10.36†    License and Collaboration Agreement, dated as of June 3, 2004, between TopoTarget A/S and the Registrant   

10-Q

(000-23223)

   8-6-2004    10.2   
  10.37†    Collaboration Agreement, dated June 18, 2004, between Seattle Genetics, Inc. and the Registrant   

10-K

(000-23223)

   3-14-2006    10.38   
   Material Contracts—Employment Agreements            
10.38#    Amended and Restated Employment Agreement, dated September 1, 2006, between the Registrant and Frank M. Armstrong, M.D.   

8-K

(000-23223)

   9-8-2006    99.1   
10.39#    Amendment, dated January 24, 2007, to Amended and Restated Employment Agreement dated September 1, 2006 between the Registrant and Frank M. Armstrong, M.D.   

10-Q

(000-23223)

   5-9-2007    10.1   
10.40#    Transition and Severance Agreement, dated September 19, 2007, between the Registrant and Frank M. Armstrong, M.D.   

10-Q

(000-23223)

   11-9-2007    10.1   
10.41#    Employment Agreement, dated September 1, 2006, between the Registrant and Paul M. Finigan   

8-K

(000-23223)

   9-8-2006    99.2   
10.42#    Amendment, dated January 24, 2007, to Employment Agreement dated September 1, 2006 between the Registrant and Paul M. Finigan   

10-Q

(000-23223)

   5-9-2007    10.2   
10.43#    Amended and Restated Employment Agreement, dated September 19, 2007, between the Registrant and Timothy M. Shannon, M.D.   

10-Q

(000-23223)

   11-9-2007    10.2   
10.44#    Amended and Restated Employment Agreement, dated September 1, 2006, between the Registrant and Elizabeth A. Whayland   

8-K

(000-23223)

   9-8-2006    99.4   
10.45#    Amendment, dated January 24, 2007, to Amended and Restated Employment Agreement dated September 1, 2006 between the Registrant and Elizabeth A. Whayland   

10-Q

(000-23223)

   5-9-2007    10.4   

 

87


Table of Contents
         

Incorporated by Reference to

    

Exhibit

No.

  

Description

  

Form and
SEC File No.

  

SEC

Filing Date

   Exhibit
No.
   Filed with
this 10-K

10.46#

   Separation Agreement, dated December 27, 2007, between the Registrant and Elizabeth A. Whayland             *

10.47#

   Amended and Restated Employment Agreement, dated September 1, 2006, between the Registrant and David M. Wurzer   

8-K

(000-23223)

   9-8-2006    99.5   

10.48#

   Amendment, dated January 24, 2007, to Amended and Restated Employment Agreement dated September 1, 2006 between the Registrant and David M. Wurzer   

10-Q

(000-23223)

   5-9-2007    10.5   

10.49#

   Amendment, dated December 17, 2007, to Amended and Restated Employment Agreement, dated September 1, 2006, as amended, between the Registrant and David M. Wurzer             *

10.50#

   Employment Agreement, dated December 14, 2007, between the Registrant and Sean A. Cassidy             *
   Additional Exhibits   

12.1

   Ratio of Earnings to Fixed Charges             *

14.1

   Code of Ethics for the Chief Executive Officer and Senior Financial Officers of the Registrant, dated November 12, 2003   

10-K

(000-23223)

   3-11-2004    14.1   

14.2

   Corporate Code of Conduct of the Registrant, dated March 1, 2004   

10-K

(000-23223)

   3-11-2004    14.2   

21.1

   Subsidiaries of the Registrant             *

23.1

   Consent of Deloitte & Touche LLP             *

31.1

   Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002             *

31.2

   Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002             *

32.1

   Certification by Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002             *

 

# Management contracts or compensatory plans or arrangements required to be filed as an exhibit hereto pursuant to Item 15(a) of Form 10-K.
Confidential treatment requested or granted as to certain portions, which portions have been separately filed with the Securities and Exchange Commission.

 

88

EX-10.9 2 dex109.htm FORM OF NONSTATUTORY STOCK OPTION AGREEMENT (EFFECTIVE JANUARY 24, 2008) Form of Nonstatutory Stock Option Agreement (Effective January 24, 2008)

Exhibit 10.9

CURAGEN CORPORATION

Nonstatutory Stock Option Agreement

Granted Under 2007 Stock Incentive Plan

1. Grant of Option.

This agreement evidences the grant by CuraGen Corporation, a Delaware corporation (the “Company”), on [DATE] (the “Grant Date”) to             , an employee of the Company (the “Participant”), of an option to purchase, in whole or in part, on the terms provided herein and in the Company’s 2007 Stock Incentive Plan (the “Plan”), a total of (words shares) (# shares) shares (the “Shares”) of common stock, $.01 par value per share, of the Company (“Common Stock”) at [PRICE] per Share. Unless earlier terminated, this option shall expire at 5:00 p.m., Eastern time, on January 24, 2018 (the “Final Exercise Date”).

It is intended that the option evidenced by this agreement shall not be an incentive stock option as defined in Section 422 of the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder (the “Code”). Except as otherwise indicated by the context, the term “Participant”, as used in this option, shall be deemed to include any person who acquires the right to exercise this option validly under its terms.

2. Vesting Schedule.

This option will become exercisable (“vest”) as to:

 

   

# SHARES Shares on the first anniversary of the date of the Agreement;

 

   

# Qtrly Shares Shares (of # total “remaining balance”) each quarter end after the first anniversary through the fourth anniversary of the date of the Agreement;

The right of exercise shall be cumulative so that to the extent the option is not exercised in any period to the maximum extent permissible it shall continue to be exercisable, in whole or in part, with respect to all Shares for which it is vested until the earlier of the Final Exercise Date or the termination of this option under Section 3 hereof or the Plan.

3. Acceleration Upon a Change in Control Event.

This option will automatically vest in full as to all the Shares effective immediately prior to a Change of Control Event. A “Change in Control Event” shall mean:

(a) the acquisition by an individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934 (the “Exchange Act”)) (a “Person”) of beneficial ownership of any capital stock of the Company if, after such acquisition, such Person beneficially owns (within the meaning of Rule 13d-3 promulgated under the Exchange Act) 50% or more of either (x) the then-outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (y) the combined voting power of the then- outstanding securities of the Company entitled to vote generally in the election of directors (the


“Outstanding Company Voting Securities”); provided, however, that for purposes of this subsection (a), the following acquisitions shall not constitute a Change in Control Event: (1) any acquisition directly from the Company (excluding an acquisition pursuant to the exercise, conversion or exchange of any security exercisable for, convertible into or exchangeable for common stock or voting securities of the Company, unless the Person exercising, converting or exchanging such security acquired such security directly from the Company or an underwriter or agent of the Company), (2) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any corporation controlled by the Company or (3) any acquisition by any corporation pursuant to a Business Combination (as defined below) which complies with clauses (x) and (y) of subsection (b) of this Section 3; or

(b) the consummation of a merger, consolidation, reorganization, recapitalization or share exchange involving the Company or a sale or other disposition of all or substantially all of the assets of the Company (a “Business Combination”), unless, immediately following such Business Combination, each of the following two conditions is satisfied: (x) all or substantially all of the individuals and entities who were the beneficial owners of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of the then-outstanding shares of common stock and the combined voting power of the then-outstanding securities entitled to vote generally in the election of directors, respectively, of the resulting or acquiring corporation in such Business Combination (which shall include, without limitation, a corporation which as a result of such transaction owns the Company or substantially all of the Company’s assets either directly or through one or more subsidiaries) (such resulting or acquiring corporation is referred to herein as the “Acquiring Corporation”) in substantially the same proportions as their ownership of the Outstanding Company Common Stock and Outstanding Company Voting Securities, respectively, immediately prior to such Business Combination and (y) no Person (excluding any employee benefit plan (or related trust) maintained or sponsored by the Company or by the Acquiring Corporation) beneficially owns, directly or indirectly, 50% or more of the then-outstanding shares of common stock of the Acquiring Corporation, or of the combined voting power of the then-outstanding securities of such corporation entitled to vote generally in the election of directors (except to the extent that such ownership existed prior to the Business Combination); or

(c) the liquidation or dissolution of the Company.

4. Exercise of Option.

(a) Form of Exercise. Each election to exercise this option shall be in writing, signed by the Participant, and received by the Company at its principal office, accompanied by this agreement, and payment in full in the manner provided in the Plan. The Participant may purchase less than the number of shares covered hereby, provided that no partial exercise of this option may be for any fractional share.

(b) Continuous Relationship with the Company Required. Except as otherwise provided in this Section 4, this option may not be exercised unless the Participant, at the time he or she exercises this option, is, and has been at all times since the Grant Date, an employee or officer of, or consultant or advisor to, the Company or any other entity the employees, officers, directors, consultants, or advisors of which are eligible to receive option grants under the Plan (an “Eligible Participant”).

 

- 2 -


(c) Termination of Relationship with the Company. If the Participant ceases to be an Eligible Participant for any reason, then, except as provided in paragraphs (d) and (e) below, the right to exercise this option shall terminate twelve (12) months after such cessation (but in no event after the Final Exercise Date), provided that this option shall be exercisable only to the extent that the Participant was entitled to exercise this option on the date of such cessation. Notwithstanding the foregoing, if the Participant, prior to the Final Exercise Date, violates the non-competition or confidentiality provisions of any employment contract, confidentiality and nondisclosure agreement or other agreement between the Participant and the Company, the right to exercise this option shall terminate immediately upon written notice to the Participant from the Company describing such violation.

(d) Exercise Period Upon Death or Disability. If the Participant dies or becomes disabled (within the meaning of Section 22(e)(3) of the Code) prior to the Final Exercise Date while he or she is an Eligible Participant and the Company has not terminated such relationship for “cause” as specified in paragraph (e) below, this option shall be exercisable, within the period of one year following the date of death or disability of the Participant, by the Participant (or in the case of death by an authorized transferee), provided that this option shall be exercisable only to the extent that this option was exercisable by the Participant on the date of his or her death or disability, and further provided that this option shall not be exercisable after the Final Exercise Date.

(e) Termination for Cause. If, prior to the Final Exercise Date, the Participant’s employment or other relationship with the Company is terminated by the Company for Cause (as defined below), the right to exercise this option shall terminate immediately upon the effective date of such termination of employment or other relationship. If the Participant is party to an employment, consulting or severance agreement with the Company that contains a definition of “cause” for termination of employment or other relationship, “Cause” shall have the meaning ascribed to such term in such agreement. Otherwise, “Cause” shall mean willful misconduct by the Participant or willful failure by the Participant to perform his or her responsibilities to the Company (including, without limitation, breach by the Participant of any provision of any employment, consulting, advisory, nondisclosure, non-competition or other similar agreement between the Participant and the Company), as determined by the Company, which determination shall be conclusive. The Participant shall be considered to have been discharged for Cause if the Company determines, within 30 days after the Participant’s resignation, that discharge for cause was warranted.

5. Withholding. No Shares will be issued pursuant to the exercise of this option unless and until the Participant pays to the Company, or makes provision satisfactory to the Company for payment of, any federal, state or local withholding taxes required by law to be withheld in respect of this option.

 

- 3 -


6. Nontransferability of Option.

This option may not be sold, assigned, transferred, pledged or otherwise encumbered by the Participant, either voluntarily or by operation of law, except by will or the laws of descent and distribution, and, during the lifetime of the Participant, this option shall be exercisable only by the Participant.

7. Provisions of the Plan.

This option is subject to the provisions of the Plan, a copy of which is furnished to the Participant with this option.

IN WITNESS WHEREOF, the Company has caused this option to be executed under its corporate seal by its duly authorized officer. This option shall take effect as a sealed instrument.

 

CURAGEN CORPORATION
By:     /s/ Sean A. Cassidy
  Name:    Sean A. Cassidy
  Title:   VP and Chief Financial Officer

PARTICIPANT’S ACCEPTANCE

The undersigned hereby accepts the foregoing option and agrees to the terms and conditions thereof. The undersigned hereby acknowledges receipt of a copy of the Company’s 2007 Stock Incentive Plan.

 

PARTICIPANT:
By:      
 

 

Name: 

   
 

 

Address: 

   
     

 

- 4 -

EX-10.18 3 dex1018.htm EXECUTIVE OFFICER COMPENSATION SUMMARY Executive Officer Compensation Summary

Exhibit 10.18

Executive Officer Compensation Summary

The executive officers of CuraGen Corporation (the “Company”) are: (i) Timothy M. Shannon, M.D., President and Chief Executive Officer; (ii) Sean A. Cassidy, Vice President and Chief Financial Officer; and (iii) Paul M. Finigan, J.D., Executive Vice President, General Counsel and Corporate Secretary.

The compensation structure for executive officers of the Company consists of three components: (i) base salary, (ii) discretionary cash bonuses or stock awards and (iii) annual performance-based non-equity and equity incentive awards under the Company’s Executive Incentive Plan (the “EIP”). Compensation decisions affecting the Company’s executive officers are made on an annual basis by the Compensation Committee of the Company’s Board of Directors (the “Committee”).

In January 2008, the Committee approved target levels for performance-based non-equity and equity incentive awards under the EIP for performance during fiscal year 2008. Achievement of target levels under the EIP is based upon the achievement of corporate performance factors established by the Company’s Board of Directors. For fiscal year 2008, these performance factors include, among other things, continued advancement of the Company’s oncology pipeline, financial performance of the Company, return for stockholders and strategic initiatives. Additional information regarding target levels for fiscal year 2008 non-equity and equity incentive awards under the EIP are provided in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on January 29, 2008.

The Committee did not implement salary increases for any of the executive officers for fiscal 2008 due to recent compensation increases in connection with the promotions and appointments described below. A summary of fiscal 2008 compensation for each executive officer appears below.

Timothy M. Shannon, M.D.

Dr. Shannon’s base salary for 2008 is $375,000. The Committee approved a non-equity incentive target level of 50% of base salary and an equity incentive target level of 200% of base salary for Dr. Shannon under the EIP for fiscal year 2008. These target levels may be increased up to 100% and 400% of base salary, respectively, for exceptional performance.

The Company entered into an amended and restated employment agreement with Dr. Shannon upon his appointment as President and Chief Executive Officer of the Company on September 19, 2007. A copy of this agreement is filed as Exhibit 10.43 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2007.

Sean A. Cassidy

Mr. Cassidy’s base salary for 2008 is $175,000. The Committee approved a non-equity incentive target level of 25% of base salary and an equity incentive target level of 75% of base salary for Mr. Cassidy under the EIP for fiscal year 2008. These target levels may be increased up to 50% and 150% of base salary, respectively, for exceptional performance.

The Company entered into an employment agreement with Mr. Cassidy on December 14, 2007 upon his appointment as Vice President and Chief Financial Officer, which was effective January 1, 2008. A copy of this agreement is filed as Exhibit 10.50 to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2007.

Paul M. Finigan, J.D.

Mr. Finigan’s base salary for 2008 is $315,000. In January 2008, the Committee approved a non-equity incentive target level of 35% of base salary and an equity incentive target level of 100% of base salary for Mr. Finigan under the EIP for fiscal year 2008. These target levels above may be increased up to 70% and 200% of base salary, respectively, for exceptional performance.

The Company is a party to an employment agreement with Mr. Finigan dated September 1, 2006, as amended January 24, 2007. This agreement is filed as Exhibit 99.2 to the Company’s Current Report on Form 8-K filed with the SEC on September 8, 2006 and the amendment to the agreement is filed as Exhibit 10.2 to the Company’s Quarter Report on Form 10-Q filed with the SEC on May 9, 2007. Mr. Finigan was promoted to the position of Executive Vice President and General Counsel on October 1, 2007.

EX-10.19 4 dex1019.htm NON-EMPLOYEE DIRECTOR COMPENSATION SUMMARY Non-Employee Director Compensation Summary

Exhibit 10.19

Non-Employee Director Compensation Summary

CuraGen Corporation’s (the “Company”) non-employee directors are currently: (i) Vincent T. DeVita Jr., M.D.; (ii) Frank M. Armstrong, M.D.; (iii) John H. Forsgren; (iv) James J. Noble, M.A., F.C.A.; (v) Robert E. Patricelli; .; and (vi) Patrick J. Zenner. The compensation structure for the Company’s non-employee directors is as follows:

Grant of Options Upon Appointment

Each non-employee director will automatically receive an option to purchase 30,000 shares of the Company’s common stock upon appointment to the Company’s Board of Directors (the “Board”). These options will vest 1/3 upon grant, 1/3 upon the first anniversary of the date of grant, and 1/3 upon the second anniversary of the date of grant (vesting will be accelerated upon a 50% or greater change in control of the Company.)

Grant of Additional Stock Options

Each non-employee director who continues to serve on the Board will automatically receive an option to purchase 15,000 shares of the Company’s common stock, granted in conjunction with each year’s Annual Meeting, such option vesting immediately.

The Non-Executive Chairman of the Board will receive an option to purchase 7,500 shares of the Company’s common stock , granted in conjunction with each year’s Annual Meeting (or granted on the date of appointment to the position and prorated for the first fiscal year of appointment, the fiscal year ending with the date of the next regularly scheduled Annual Meeting), such option vesting immediately.

The Audit Committee Chair will receive an option to purchase 5,000 shares of the Company’s common stock, granted in conjunction with each year’s Annual Meeting (or granted on the date of appointment to the position and prorated for the first fiscal year of appointment, the fiscal year ending with the date of the next regularly scheduled Annual Meeting), such option vesting immediately.

The Compensation Committee Chair and the Nominating & Governance Committee Chair will receive an option to purchase 2,500 shares of the Company’s common stock, granted in conjunction with each year’s Annual Meeting (or granted on the date of appointment to the position and prorated for the first fiscal year of appointment, the fiscal year ending with the date of the next regularly scheduled Annual Meeting), such option vesting immediately.

Payment of Fees: Reimbursement of Travel and Other Expenses

In addition to the above mentioned stock option grants, each non-employee director will receive an annual retainer of $20,000 for his service on the Board during 2008. [This retainer will be prorated for any non-employee director who serves for only part of the year.] Additional amounts will be paid to the non-employee directors during 2008 as follows:

 

Position

   Additional
Fees

Non-Executive Chairman of the Board - Retainer

   $ 30,000

Audit Committee Chair – Retainer

   $ 15,000

Compensation Committee Chair - Retainer

   $ 10,000

Nominating & Governance Committee Chair - Retainer

   $ 10,000

Board meeting fee - regular meeting

   $ 1,500

Board meeting fee - telephonic meeting

   $ 750

Audit Committee meeting - Each member

   $ 1,250

Compensation Committee meeting - Each member

   $ 1,000

Nominating & Governance meeting - Each member

   $ 1,000

Audit Committee telephonic meeting - Each member

   $ 1,000

Compensation Committee telephonic meeting - Each member

   $ 750

Nominating & Governance telephonic meeting - Each member

   $ 750

Per diem for additional work performed on site, in support of Board and/or Committee responsibilities

   $ 1,000

All retainer amounts will be paid quarterly during the fiscal year. Non-employee directors also receive reimbursement for reasonable travel and other expenses in connection with attending Board and committee meetings during the fiscal year.

EX-10.46 5 dex1046.htm SEPARATION AGREEMENT, DATED DECEMBER 27, 2007 Separation Agreement, dated December 27, 2007

Exhibit 10.46

AGREEMENT AND GENERAL RELEASE

CuraGen Corporation (hereinafter “CuraGen” or the “Company”) and Elizabeth A. Whayland, her heirs, executors, administrators, successors, and assigns (hereinafter collectively referred to as “Employee”), agree that:

1. Separation from Service. Employee shall provide services to CuraGen without reduction in compensation or benefits through December 31, 2007 and shall separate from service on January 1, 2008, which shall be her last day of employment with CuraGen (the “Separation from Service Date”). For purposes of this Agreement, the term “Separation from Service” shall have the same meaning as that accorded the term under the default rule contained in Treasury Regulation Section 1.409A-l(h)(l)(ii).

2. Eligibility Requirements. Employee is eligible for severance and other benefits based on her Employment Agreement entered into on or about September 1, 2006 (“Employment Agreement”).

3. Time Limits. In order to receive the benefits offered under the Employment Agreement and any other benefits outlined below, Employee must sign and return this Agreement to Nathalie Richard, Director of Human Resources, before the expiration of the 21 day consideration period ending on January 22, 2008. Once this period of time expires, Employee will not be permitted to elect to receive severance benefits in connection with the Employment Agreement.

4. Consideration. In consideration for Employee signing this Agreement and General Release and complying with it and the terms of her Employment Agreement, CuraGen agrees upon the Separation from Service Date:

 

  a) To pay to Employee the lump sum amount of $223,660 less applicable taxes and withholdings, solely on account of involuntary severance as soon as administratively practicable following satisfaction of the conditions for payment specified in paragraph 3 and 4.c., but no later than sixty days after the Separation from Service Date.

 

  b) If Employee properly and timely elects to continue coverage under the Company’s group health plan in accordance with the plan’s COBRA continuation requirements, CuraGen will cause the cost of COBRA coverage for the Employee (and her eligible covered dependents) to be adjusted such that the Company shall pay premiums at the same percentage as if the Employee were still then actively employed for a period commencing on the Employee’s Separation from Service Date, and ending on the earlier of either January 31, 2009, or the date on which the Employee becomes eligible to participate in any other employer sponsored group health plan, all as provided under Paragraph 11(C) of the Employment Agreement. Thereafter, Employee shall be entitled to continue such COBRA coverage for the remainder of the COBRA period at her own expense.


  c) The salary continuation and other benefits payable to Employee are conditioned upon the occurrence of the following: 1) the Company’s receipt of Employee’s executed Agreement and General Release; 2) the expiration of the seven day revocation period set forth below; and 3) the Company’s receipt of the letter signed by Employee in the form attached hereto as Exhibit A more than seven (7) calendar days after the execution of the Agreement and General Release.

 

  d) In the event that a Change in Control (as defined in Section 10 of the Employment Agreement) occurs within twelve months of the Employee’s Separation from Service Date, then Employee shall be entitled to an additional $223,660 paid ratably over a 12 month period, which shall commence on January 1, 2009, an additional two times the Employee’s target annual bonus, based on her compensation immediately prior to her Separation from Service and paid in a lump sum in January 2009, together with up to an additional 12 months of employer paid COBRA continuation coverage (or if applicable, payments in lieu thereof), all as provided in Section 11(D) of the Employment Agreement. Notwithstanding anything in this Plan to the contrary, CuraGen and Employee may mutually agree to pay all or a portion of the Employee’s severance pay benefits specified in this paragraph 4.d. prior to the time specified in this Agreement, but only to the extent such acceleration is not prohibited under Code Section 409A.

 

  e) The provisions of this paragraph 4 shall constitute an election as to form of payment in accordance with Section 3.02 of IRS Notice 2006-79, as subsequently may be modified, and a modification of the applicable provisions of the Employment Agreement to permit such election and to restrict the events on which such severance shall be paid to involuntary severance.

5. Additional Consideration. In addition to the salary continuation and other benefits identified in the Employment Agreement and in consideration for Employee signing this Agreement and General Release, CuraGen agrees:

 

  a) To pay to Employee after the determination in January 2008 and on or before March 15, 2008, her 2007 Executive Incentive Target cash bonus, in an amount equal to the greater of 1) 100% of target; or 2) consistent with the percentage of target attributed to the Executive Management team as approved by the Compensation Committee of the Board of Directors in January 2008.

 

  b) To pay to Employee after the determination in January 2008 and on or before March 15, 2008, any additional cash bonus consistent with the percentage paid to the Executive Management team, as approved by the Compensation Committee of the Board of Directors in January 2008, as it relates to the achievement of the net cash goal for 2007;

 

  c)

The amounts listed above in 5.a. and 5.b. will be paid in one installment, minus appropriate withholdings and deductions once the following has occurred: 1) The

 

2


 

Compensation Committee of the Board of Directors has approved the payments; 2) the Company’s receipt of Employee’s executed Agreement and General Release; 3) the expiration of the seven day revocation period set forth below; and 4) the Company’s receipt of the letter signed by Employee in the form attached hereto as Exhibit A more than seven (7) calendar days after the execution of the Agreement and General Release;

 

  d) To pay to Employee the cash value of 9,895 restricted shares at the closing price on December 31, 2007. This amount will be paid within one week after the following has occurred: 1) the Company’s receipt of Employee’s executed Agreement and General Release; 2) the expiration of the seven day revocation period set forth below; and 3) the Company’s receipt of the letter signed by Employee in the form attached hereto as Exhibit A more than seven (7) calendar days after the execution of the Agreement and General Release.

 

  e) To provide Employee with outplacement services through a resource of the Employee’s choice at a cost not to exceed $10,000. The Employee will have 12 months from December 31, 2007 to locate, make payment, and request reimbursement for this service.

6. No Consideration Absent Execution of this Agreement. Employee understands and agrees that Employee would not receive the monies and/or benefits specified in Paragraphs 4 and 5 above, except for her execution of this Agreement and General Release and the fulfillment of the promises contained herein.

7. General Release of All Claims. Except with respect to benefit claims that are accrued but not paid on the date of this Agreement under the express terms of the “Designated Company Employee Benefit Plans” (as defined below) as in effect on such date, and to which the Employee is entitled thereunder in the ordinary course, Employee knowingly and voluntarily releases and forever discharges CuraGen Corporation, its parent, affiliates, subsidiaries, divisions, predecessors, successors and assigns and the current and former employees, attorneys, officers, directors, partners and agents thereof, both individually and in their official capacities (collectively referred to throughout the remainder of this Agreement as “Releasees”), of and from any and all claims, known and unknown, asserted and unasserted, which Employee has or may have against Releasees as of the date of her execution of this Agreement and General Release, including, but not limited to, any alleged violation of:

 

   

Title VII of the Civil Rights Act of 1964;

 

   

Sections 1981 through 1988 of Title 42 of the United States Code;

 

   

The Employee Retirement Income Security Act of 1974 (“ERISA”) (except for any vested benefits under any tax qualified benefit plan);

 

   

The Immigration Reform and Control Act;

 

3


   

The Americans with Disabilities Act of 1990;

 

   

The Age Discrimination in Employment Act of 1967 (“ADEA”);

 

   

The Workers Adjustment and Retraining Notification Act;

 

   

The Fair Credit Reporting Act;

 

   

The Sarbanes-Oxley Act of 2002;

 

   

Connecticut Fair Employment Practices Act, Conn. Gen. Stat. § 46a-51 et seq.;

 

   

The Connecticut Statutory Provision Regarding Retaliation/Discrimination for Filing a Workers’ Compensation Claim, Conn. Gen. Stat. § 3 l-290a;

 

   

Connecticut Family and Medical Leave Act, Conn. Gen. Stat. § 31-51 kk et seq.;

 

   

The Connecticut Whistleblower Law, Conn. Gen. Stat. § 31-51m;

 

   

The Connecticut Free Speech Law, Conn. Gen. Stat. § 31-51q;

 

   

Connecticut Wage Hour and Wage Payment Laws, as amended;

 

   

Connecticut OSHA, as amended;

 

   

Any other federal, state or local civil or human rights law or any other federal, state or local law, regulation or ordinance;

 

   

Any obligation or claim arising under any public policy, contract (express or implied, written or oral), tort, or common law, including but not limited to, wrongful discharge, defamation, emotional distress, misrepresentation and/or obligations arising out of any of CuraGen’s employment policies or practices, employee handbooks and/or any statements by any employee or agent of CuraGen whether oral or written; and

 

   

Any allegation for costs, fees, or other expenses including attorneys’ fees incurred in connection with Employee’s termination of employment and/or consideration of this Agreement and General Release.

Solely for purposes of this Paragraph 7, the term “Designated Company Employee Benefit Plans” shall mean the CuraGen Corporation group medical and dental benefits plan, and vested exercise rights under the terms of any stock option plan. Furthermore, no provision in this paragraph 7 shall cause Employee to either waive or release any rights that Employee may have to enforce the terms of this Agreement and General Release.

 

4


8. Affirmations.

Employee affirms that she has not filed, caused to be filed, or presently is a party to any claim, lawsuit or other action against CuraGen in any forum or form.

Employee also affirms that she has been paid and/or has received all compensation, wages, bonuses, commissions, stock options and/or benefits to which she may be entitled, except as provided in this Agreement and General Release. Employee affirmatively waives any right to salary continuation or other benefits contained in the Employment Agreement except as provided in this Agreement and General Release OR for those identified in Paragraph 11(C) and 11(D). Employee acknowledges that she continues to be bound by the terms of the Employment Agreement including, but not limited to, the requirements of Paragraphs 6, 7, 8 and 12 of the Employment Agreement.

Employee further affirms that she has no known workplace injuries or occupational diseases. Employee affirms that she has been granted all leaves (paid and unpaid) to which she was entitled under the state or federal Family and Medical Leave Act and that she has not been discriminated against or retaliated against due to her exercise of rights, if any, under the state and/or federal Family and Medical Leave Act. Employee affirms that following Employee’s termination of employment, Employee will provide information, assist and cooperate with CuraGen in executing CuraGen’s patent filings.

Employee affirms that she has not been retaliated against for reporting any allegations of wrongdoing or inappropriate conduct by CuraGen or its officers, including any allegations of corporate or financial fraud. Both parties to this Agreement acknowledge that this Agreement does not limit either party’s right, where applicable, to file or participate in an investigative proceeding of any federal, state of local governmental agency. To the extent permitted by law, Employee agrees that if such an administrative charge is made, she shall not be entitled to recover any individual monetary relief or other individual remedies. Employee further acknowledges and affirms that should she commence, or become a party to, any lawsuit against CuraGen filed in federal or state court, she waives her right to any monetary recovery or damages, including attorneys’ fees.

9. Confidentiality and Return of Property. Employee agrees not to disclose any information regarding the existence or substance of this Agreement and General Release, except to her spouse, tax advisor, and/or an attorney with whom Employee chooses to consult regarding her consideration of this Agreement and General Release.

Employee affirms that she has not divulged any proprietary or confidential information of CuraGen and that she will continue to maintain the confidentiality of such information consistent with CuraGen’s policies and the common law

 

5


Employee affirms that she has returned all of company property, documents, and/or any confidential information in her possession or control. Employee agrees to deliver to CuraGen without copying or reproducing: 1) all documents, files, notes, memoranda, manuals, computer disks, computer databases, computer programs and/or other storage medium within Employee’s possession or control that reflect any trade secrets, proprietary information or other confidential information; and 2) all items or other forms of CuraGen’s property and/or equipment within Employee’s possession or control, including but not limited to keys, credit cards, furniture, electronic equipment and vehicles. Immediately upon Employee’s execution of this Agreement and General Release or at any time CuraGen otherwise requests, Employee also agrees to delete any proprietary or confidential information relating to CuraGen from any computer hard drive or computer system within Employee’s possession or control that is not located on CuraGen’s premises. Nothing in this paragraph will prevent Employee from retaining any documents in her possession or control concerning his or her employee benefits and/or her compensation.

Employee also affirms that she is in possession of all of Employee’s property that Employee had at CuraGen’s premises and that CuraGen is not in possession of any of her property.

10. Governing Law and Interpretation. This Agreement and General Release shall be governed and conformed in accordance with the laws of the state of Connecticut without regard to its conflict of laws provision. In the event of a breach of any provision of this Agreement and General Release, either party may institute an action specifically to enforce any term or terms of this Agreement and General Release and/or to seek any damages for breach. Should any provision of this Agreement and General Release be declared illegal or unenforceable by any court of competent jurisdiction and cannot be modified to be enforceable, excluding the general release language, such provision shall immediately become null and void, leaving the remainder of this Agreement and General Release in full force and effect.

11. Nonadmission of Wrongdoing. The parties agree that neither this Agreement and General Release nor the furnishing of the consideration for this Agreement and General Release shall be deemed or construed at any time for any purpose as an admission by CuraGen of wrongdoing or evidence of any liability or unlawful conduct of any kind.

12. Severability. Should any provision or language in this Agreement and General Release other than the general release of all claims be declared illegal or unenforceable by any court of competent jurisdiction and cannot be modified to be enforceable, such provision or language shall immediately become null and void, leaving the remainder of this Agreement and General Release in full force and effect.

13. Section 409A. It is intended that all payments made under the terms of this Agreement come within exceptions to Section 409A of the Internal Revenue of 1986, as amended (Section 409A), including transition guidance issued thereunder. This Agreement and all related documents shall be interpreted and administered in accordance with that intention. However, if any amount payable under this Agreement is determined to be subject to Section 409A, then any amount to be paid or provided to the Employee in connection with a separation

 

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from service at a time when she is considered a specified employee within the meaning of Section 409A shall not be made until the date that is six months and one day following such Separation from Service, or in a lump sum to her estate upon her earlier death.

14. Amendment. This Agreement and General Release may not be modified, altered or changed except in writing and signed by both parties wherein specific reference is made to this Agreement and General Release.

15. Entire Agreement. This Agreement and General Release sets forth the entire agreement between the parties hereto, and fully supersedes any prior agreements or understandings between the parties except for the Employment Agreement and the CuraGen Confidentiality Agreement previously executed and agreed to by Employee. Employee acknowledges that she has not relied on any representations, promises, or agreements of any kind made to her in connection with her decision to accept this Agreement and General Release, except for those set forth in this Agreement and General Release.

EMPLOYEE IS ADVISED THAT SHE HAS TWENTY-ONE (21) CALENDAR DAYS TO CONSIDER THIS AGREEMENT AND GENERAL RELEASE. EMPLOYEE ALSO IS ADVISED TO CONSULT WITH AN ATTORNEY PRIOR TO SIGNING THIS AGREEMENT AND GENERAL RELEASE.

EMPLOYEE MAY REVOKE HER ACCEPTANCE OF THIS AGREEMENT FOR A PERIOD OF SEVEN (7) CALENDAR DAYS FOLLOWING THE DATE EMPLOYEE SIGNS THIS AGREEMENT AND GENERAL RELEASE. ANY REVOCATION WITHIN THIS PERIOD MUST BE SUBMITTED, IN WRITING, TO NATHALIE RICHARD, DIRECTOR OF HUMAN RESOURCES, AND STATE, “I HEREBY REVOKE MY ACCEPTANCE OF OUR AGREEMENT AND GENERAL RELEASE.” THE REVOCATION MUST BE PERSONALLY DELIVERED TO MS. RICHARD, OR MAILED TO MS. RICHARD AND POSTMARKED WITHIN SEVEN (7) CALENDAR DAYS AFTER EMPLOYEE SIGNS THIS AGREEMENT AND GENERAL RELEASE.

EMPLOYEE AGREES THAT ANY MODIFICATIONS, MATERIAL OR OTHERWISE, MADE TO THIS AGREEMENT AND GENERAL RELEASE DO NOT RESTART OR AFFECT IN ANY MANNER THE ORIGINAL TWENTY-ONE (21) CALENDAR DAY CONSIDERATION PERIOD.

 

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EMPLOYEE FREELY AND KNOWINGLY, AND AFTER DUE CONSIDERATION, ENTERS INTO THIS AGREEMENT AND GENERAL RELEASE INTENDING TO WAIVE, SETTLE AND RELEASE ALL CLAIMS SHE HAS OR MIGHT HAVE AGAINST RELEASEES AS SET FORTH IN PARAGRAPH 7 ABOVE.

The parties knowingly and voluntarily sign this Agreement and General Release as of the date(s) set forth below:

 

    CURAGEN CORPORATION
By:     /s/ Elizabeth A. Whayland     By:     /s/ Timothy M. Shannon
Elizabeth A. Whayland    

Name:  Timothy M. Shannon

Title:    President & CEO

Date: 12-27-07     Date: 12.14.07

 

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EX-10.49 6 dex1049.htm AMENDMENT, DATED DECEMBER 17, 2007 Amendment, dated December 17, 2007

Exhibit 10.49

Confidential

LOGO

Memorandum

 

To:    David M. Wurzer, Executive Vice-President & CFO
From:    Timothy M. Shannon, President & CEO
Date:    December 20, 2007
Re:    Addendum to Employment Agreement

This memo will serve as and Addendum to the Employment Agreement (“the Agreement”) you executed with your employer, CuraGen Corporation (“the Company”), on or about September 1, 2006.

David M. Wurzer (“the Executive”) and the Company have agreed to modify the terms of that Agreement as follows, effective January 1, 2008:

 

  1. (Section 1 A. – Employment; Duties and Responsibilities.)

The Company shall employ the Executive, and the Executive shall serve the Company, as Advisor to the Company, with such duties and responsibilities as may be assigned to the Executive by the Chief Executive Officer (“CEO”) of the Company and are typically associated with a position of that nature.

Notwithstanding the change of title of Executive from EVP & CFO to Advisor effective January 1, 2008 as provided above, Executive shall be entitled to all year-end bonuses and other compensation for his role as EVP & CFO for the year ending December 31, 2007 which are consistent with the Company’s Executive Incentive Plan for 2007 for Executive and other senior executives of the Company, except for the Long Term Equity component of the EIP.

Unless explicitly changed in this Addendum, all other terms of the Agreement shall remain in full force and effect.

The parties knowingly and voluntarily sign this Addendum as of the date set forth below

 

    CuraGen Corporation
By:     /s/ David M. Wurzer     By:     /s/ Timothy M. Shannon
David M. Wurzer    

Name:  Timothy M. Shannon

Title:    President & CEO

Date: December 20, 2007     Date: December 20, 2007
EX-10.50 7 dex1050.htm EMPLOYMENT AGREEMENT, DATED DECEMBER 14, 2007 Employment Agreement, dated December 14, 2007

Exhibit 10.50

THIS EMPLOYMENT AGREEMENT (“Agreement”) entered into as of December 14, 2007 and effective as of January 1, 2008, between CuraGen Corporation, a corporation organized under the laws of the State of Delaware, with its principal place of business at 322 East Main Street, Branford, Connecticut (the “Company”), and Sean A. Cassidy (“Executive”) to provide for the continued employment of Executive.

WHEREAS, the Executive desires to continue to be employed by the Company, subject to the terms and conditions of this Agreement; and the Company desires to retain the Executive’s services, subject to the terms and conditions of this Agreement.

THEREFORE, the Company and the Executive, intending to be legally bound, hereby agree as follows:

 

1. Employment; Duties and Responsibilities

A) The Company shall employ the Executive, and the Executive shall serve the Company, as Vice President and Chief Financial Officer (“CFO”), with such duties and responsibilities as may be assigned to the Executive by the Chief Executive Officer (“CEO”) of the Company and are typically associated with a position of that nature.

B) The Executive shall devote his best efforts and all of his business time to the performance of his duties under this Agreement and shall perform them faithfully, diligently and competently in a manner consistent with the policies and goals of the Company as determined from time to time by the CEO or an officer of the Company.

C) The Executive shall report to the CEO of the Company, or identified member of the Executive Committee.


D) The Executive shall not engage in any activities outside the scope of his employment that would detract from, or interfere with, the fulfillment of his responsibilities or duties under this Agreement.

E) The Executive shall not serve as a director (or the equivalent position) of any company or entity and shall not render services of a business, professional or commercial nature to any other person or firm, except for not-for-profit entities, without prior written consent of the CEO. Such consent shall not be unreasonably withheld.

F) The Executive shall not receive fees or other remuneration for work performed either within or outside the scope of his employment without prior written consent of the CEO. Such consent shall not be unreasonably withheld.

 

2. Term of Employment

The Executive’s employment pursuant to this Agreement shall be effective as of January 1, 2008. The Executive is employed on an at-will basis, and, subject to the provisions of Section 9 and 11, either the Executive or the Company may terminate the employment relationship at any time for any reason.

 

3. Compensation

As full compensation for all services rendered by the Executive to the Company under this Agreement, the Company shall pay the Executive the compensation set forth in Schedule A attached and incorporated into this Agreement. This schedule may be amended from time to time in writing by the Company and the Executive.

 

4. Fringe Benefits

A) Fringe Benefits: The Executive shall be entitled to participate in employee benefit plans which the Company provides or may establish for the benefit of its senior executives

 

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generally (for example, group life, disability, medical, dental and other insurance, retirement, pension, profit-sharing and similar plans) (collectively, the “Fringe Benefits”). Eligibility to participate in the Fringe Benefits and receive benefits thereunder is subject to the plan documents governing such Fringe Benefits. Nothing contained herein shall require the Company to establish or maintain any Fringe Benefits, and such Fringe Benefits may be modified from time to time in the Company’s discretion.

B) Vacation: The Executive shall be entitled to accrue on an annual basis 20 paid vacation days in accordance with the Company’s policies as in effect from time to time. All vacation days will be taken at times selected by him, with the prior approval of the person to whom the Executive is to report.

C) Directors’ and Officers’ Insurance: The Executive shall be covered under the Company’s directors’ and officers’ insurance coverage to the same extent as other officers of the Company.

 

5. Expenses

The Company shall reimburse the Executive for all reasonable and necessary expenses incurred by him in connection with the performance of his services for the Company in accordance with the Company’s policies, upon submission of appropriate expense reports and documentation in accordance with the Company’s policies and procedures.

 

6. Patents, Copyrights and Intellectual Property

A) The Executive shall promptly disclose to the Company all Inventions. Inventions shall mean, for purposes of this paragraph, inventions, discoveries, developments, methods and processes (whether or not patentable or copyrightable or constituting trade secrets) conceived, made or discovered by the Executive (whether alone or with others) while employed by the

 

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Company that relate, directly or indirectly, to the past, present, or future business activities, research, product design or development, personnel, and business opportunities of the Company, or result from tasks assigned to the Executive by the Company or done by the Executive for or on behalf of the Company or any affiliate, subsidiary, division or parent of the Company (collectively with the Company, the “Company Group”). The Executive hereby assigns and agrees to assign to the Company (or as otherwise directed by the Company) his full right, title and interest in and to all Inventions. The Executive agrees to execute any and all applications for domestic and foreign patents, copyrights or other proprietary rights and to do such other acts (including, among others, the execution and delivery of instruments of further assurance or confirmation) requested by the Company to assign the Inventions to the Company and to permit the Company to file, obtain and enforce any patents, copyrights or other proprietary rights in the Inventions. The Executive agrees to make and maintain adequate and current records of all Inventions, in the form of notes, sketches, drawings, or reports relating thereto, which records shall be and remain the property of and available to the Company at all times.

B) All designs, ideas, inventions, improvements, and other creations made or owned by the Executive before becoming an employee of the Company and which the Executive desires to exempt from this Agreement are listed on Attachment A hereof and authorized for exclusion by the signature of an Officer of the Company. (If the Executive does not have any such designs, ideas, inventions, improvements, or other creations write “none” on this line:         .)

C) The Executive agrees to notify the Company in writing before the Executive makes any disclosure or performs or causes to be performed any work for or on behalf of the Company, which appears to threaten or conflict with (a) rights the Executive claims in any invention or idea conceived by the Executive or others (i) prior to the Executive’s employment,

 

4


or (ii) otherwise outside the scope of this Agreement; or (b) rights of others arising out of obligations incurred by the Executive (i) prior to this Agreement, or (ii) otherwise outside the scope of this Agreement. In the event of the Executive’s failure to give notice under the circumstances specified, the Company may assume that no such conflicting invention or idea exists and the Executive agrees that the Executive will make no claim against the Company with respect to the use of any such invention or idea in any work which the Executive performs or causes to be performed for or on behalf of the Company.

 

7. Proprietary and Trade Secret Information

A) The Executive agrees that he will keep confidential and will not make any unauthorized use or disclosure, or use for his own benefit or the benefit of others, during or subsequent to his employment of any research, development, engineering and manufacturing data, plans, designs, formulae, processes, specifications, techniques, trade secrets, financial information, customer or supplier lists or other information that becomes known to him as a result of his employment with the Company which is the property of any member of the Company Group or any of its clients, customers, consultants, licensors, or licensees, provided nothing herein shall be construed to prevent the Executive from using his general knowledge and skill after termination of his employment whether acquired prior to or during his employment by the Company.

B) Proprietary information subject to paragraph 7(A) does not include information that: (i) is or later becomes available to the public through no breach of this Agreement by the Executive; (ii) is obtained by the Executive from a third party who had the legal right to disclose the information to the Executive; or (iii) is required to be disclosed by law, government regulation, or court order.

 

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C) During the course of his employment with the Company, the Executive will not accept information from sources outside of the Company, which is designated as “Confidential,” or “Proprietary,” or “Trade Secret” without prior written permission from the Company or its attorneys. The Executive is not expected to and is expressly forbidden by the Company policy from disclosing to the Company a “Trade Secret” or “Confidential” or “Proprietary” information from a former employer.

D) Upon leaving the employment of the Company, the Executive will not remove from the Company Group’s premises, either directly or indirectly, any drawings, writings, prints, any documents or anything containing, embodying, or disclosing any confidential or proprietary information or any of the Company Group’s trade secrets unless express written permission is given by the Company management. Upon termination of his employment, the Executive shall return to the Company any and all documents and materials that are the property of any member of the Company Group or its customers, licensees, licensors or affiliates or which contain information that is the property of any member of the Company Group.

 

8. Covenant Not to Compete

A) While in the employ of the Company and for a period of one year or the maximum period permitted by applicable law (whichever is shorter) following termination of his employment with the Company, the Executive shall not, without the approval of the Company, alone or as a partner, officer, director, consultant, employee, stockholder or otherwise, engage in any employment, consulting or business activity or occupation that is or is intended to be directly competitive with the business of the Company, as being considered, researched, developed, marketed and/or sold at the time of termination; provided, however, that the holding by the Executive of any investment in any security shall not be deemed to be a violation of this section

 

6


if such investment does not constitute over one percent (1%) of the outstanding issue of such security. The restriction shall run for a period of one year after said termination, and if there shall be any violation hereof during said period, then for a period of one year after cessation of such violation.

B) The Executive shall not, directly or indirectly, either during the term of the Executive’s employment under this Agreement or for a period of one (1) year thereafter, solicit or attempt to solicit, directly or indirectly, the services of any person who was a full-time employee of any member of the Company Group or solicit or attempt to solicit the business of any person who was a client or customer of any member of the Company Group at any time during the last year of the term of the Executive’s employment under this Agreement. The Executive shall not, directly or indirectly, either during the term of the Executive’s employment under this Agreement or for a period of one (1) year thereafter, employ or attempt to employ, directly or indirectly, the services of any person who was a full-time employee of any member of the Company Group, or solicit the business of any person who was a client or customer of any member of the Company Group at any time during the last year of the term of the Executive’s employment under this Agreement. For purposes of this Agreement, the term “person” shall include natural persons, corporations, business trusts, associations, sole proprietorships, unincorporated organizations, partnerships, joint ventures and governments or any agencies, instrumentalities or political subdivisions thereof.

C) The Executive acknowledges and agrees that the covenants in this section are necessary for the protection of the legitimate business interests of the Company and that the covenants are reasonable in all respects. The Executive further acknowledges and agrees that, if his employment by the Company is terminated, his experience and capabilities are such that he is

 

7


both qualified and willing to seek and obtain employment involving business activities which will not violate any covenant on his part to be observed hereunder and that a court decree enjoining any such violation will not prevent him from earning a reasonable livelihood.

D) Just compensation for the duties under this paragraph is included in the salary and benefits provided herein.

E) If the Executive is terminated as a result of a Change of Control, as defined in this Agreement, this Section, titled “Covenant Not to Compete,” shall not be applicable.

F) The parties agree that if any provision of this Section 8 is held invalid or unenforceable by a court of competent jurisdiction, that part should be modified by the court to make it enforceable to the maximum extent possible. If the part cannot be modified, then that part may be severed and the other parts of this Agreement shall remain enforceable.

 

9. Termination

A) The Company shall have the right to terminate the Executive’s employment with the Company at any time for any reason, including for Executive’s Disability, Performance Reasons or with or without Cause (all terms as defined in this Agreement).

B) The Executive’s employment shall terminate automatically upon his death.

C) The Executive shall have the right to terminate the Executive’s employment with the Company at any time for any reason, including with Good Reason (as that term is defined in this Agreement).

D) For purposes of this Agreement, the term “Performance Reasons” shall mean termination of the Executive’s employment upon the assessment of the Chief Executive Officer, or the Board of Directors, or a Committee of the Board of Directors that the Executive has failed to satisfactorily perform the essential functions of the Executive’s position. Such a determination shall be made using acceptable business practices and sound management principles and shall not be made in bad faith or arbitrarily.

 

8


E) For purposes of this Agreement, the term “Cause” shall mean the Executive’s willfully engaging in conduct demonstrably and materially injurious to the Company, monetarily or otherwise, provided that the Executive receives a copy of a resolution duly adopted by the unanimous affirmative vote of the entire disinterested membership of the Board of Directors of the Company (“BOD”) at a meeting of the BOD called and held for such purpose after the Executive has been given reasonable notice of such meeting and has been given an opportunity, together with his counsel, to be heard by the Board of the Company, finding that in the good faith opinion of the Board of the Company the Executive was guilty of the conduct set forth and specifying the particulars thereof in detail.

F) The Executive’s act, or failure to act, shall be deemed “willful” if the Executive was not acting in good faith or acting without reasonable belief that the Executive’s action or omission was in the best interests of the Company. Any act or failure to act based on authority given pursuant to a resolution duly adopted by the Board of the Company, or based upon the advice of counsel for the Company shall be conclusively presumed to have been done by the Executive in good faith and in the best interests of the Company.

G) For purposes of this Agreement, “Disability” shall mean (A) Executive is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, or (B) Executive is, by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, receiving

 

9


income replacement benefits for a period of not less than three (3) months under a Company-sponsored group disability plan. A determination of Disability shall be made in good faith by a majority vote of the Board, based on the opinion of one or more physicians mutually agreed to by Executive and the Company.

H) For the purposes of this Agreement, termination by the Executive of his employment for “Good Reason” shall mean termination based on:

(i) subsequent to a Change in Control of the Company (as hereafter defined), and without the Executive’s express written consent, any material reduction in Executive’s duties or responsibilities compared to those prior to a Change in Control, or a material change in the Executive’s reporting responsibilities, titles or offices as in effect immediately prior to a Change in Control, or any material removal of the Executive from, or any material failure to re-elect the Executive, to any of his previously held positions with the Company, except in connection with the termination of the Executive’s employment for Cause, Disability or Retirement or as a result of the Executive’s death or by the Executive other than for Good Reason;

(ii) subsequent to a Change in Control of the Company, a reduction by the Company in the Executive’s base salary as in effect on the date hereof or as the same may be increased from time to time;

(iii) subsequent to a Change in Control of the Company, a failure by the Company to continue any bonus plans in which the Executive is presently entitled to participate (the “Bonus Plans”) as the same may be modified from time to time but substantially in the form currently in effect, or a failure by the Company to continue the

 

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Executive as a participant in the Bonus Plans on at least the same basis as the Executive presently participates in accordance with the Bonus Plans;

(iv) subsequent to a Change in Control of the Company and without the Executive’s express written consent, the Company’s requiring the Executive to be based anywhere other than within fifty (50) miles of the Executive’s present office location, except for required travel on the Company’s business to an extent substantially consistent with the Executive’s present business travel obligations;

(v) subsequent to a Change in Control of the Company, the taking of any action by the Company which would adversely affect the Executive’s participation in or materially reduce the Executive’s benefits under any benefit plans or deprive the Executive of any material fringe benefit enjoyed by the Executive at the time of the Change in Control, or the failure by the Company to provide the Executive with the number of paid vacation days to which the Executive is then entitled in accordance with the Company’s normal vacation policy in effect on the date hereof; or

(vi) subsequent to a Change in Control of the Company, any purported termination of the Executive’s employment which is not effected pursuant to the terms of this Agreement. No such purported termination shall be effective.

 

10. Change in Control

A) “Change in Control” of the Company shall mean the occurrence of any one of the following events with respect to the Company, but only to the extent each of the following is interpreted in a manner consistent with the meaning of “a change in the ownership or effective control of the corporation, or in the ownership of a substantial portion of the assets of the corporation” under Section 409A of Internal Revenue Code, as amended, (the “Code

 

11


Section 409A”) and any successor statute, regulation and guidance thereto, and limited to the extent necessary so that it will not cause adverse tax consequences with respect to Code Section 409A:

(i) such time as the majority of the members of the BOD is replaced during any 12-month period (commencing no earlier than the Commencement Date) by directors whose appointment or election is not endorsed by a majority of the members of the BOD prior to the date of appointment or election;

(ii) the acquisition by any “Person” (as such term is defined in Section 3(a)(9) of the Securities Exchange Act of 1934 (the “Exchange Act”) and as used in Section 13(d)(3) and 14(d)(2) of the Exchange Act) of the beneficial ownership of any capital stock of the Company if, after such acquisition, such person beneficially owns (within the meaning of Rule 13d-3 under the Exchange Act) more than 50% of the combined voting power of the Company’s then outstanding securities eligible to vote for the election of the BOD (the “Company Voting Securities”); provided, however, that the event described in this paragraph (ii) shall not be deemed to be a Change in Control by virtue of any of the following: (a) an acquisition by the Company or any subsidiary of the Company; (b) an acquisition by any employee benefit plan sponsored or maintained by the Company or subsidiary of the Company; (c) an acquisition by any underwriter temporarily holding securities pursuant to an offering of such securities; or (d) an acquisition by any Person who, prior to such acquisition, already owned more than 50% of the Company Voting Securities;

(iii) the consummation of a merger, consolidation, statutory share exchange, a sale or other disposition of all or substantially all of the assets of the Company or similar

 

12


form of corporate transaction involving the Company (a “Business Combination”), unless immediately following such Business Combination at least 50% of the total voting power of (x) the corporation resulting from such Business Combination (the “Surviving Corporation”), or (y) if applicable, the ultimate parent corporation that directly or indirectly has beneficial ownership of 100% of the voting securities eligible to elect directors of the Surviving Corporation, is represented by Company Voting Securities that were outstanding immediately prior to such Business Combination (or, if applicable, shares into which such Company Voting Securities were converted pursuant to such Business Combination); or

(iv) the stockholders of the Company approve a plan of complete liquidation or dissolution of the Company, but only if such approval is in connection with one of the events described in Section 10(A)(i)-(iii) above.

B) Notwithstanding the foregoing, a Change in Control of the Company shall not be deemed to occur solely because any Person acquires beneficial ownership of more than 50% of the Company Voting Securities as a result of the acquisition of Company Voting Securities by the Company which reduces the number of Company Voting Securities outstanding.

C) Upon a Change of Control, notwithstanding any other agreement, all stock, restricted stock, stock options or restricted stock options of the Executive shall become fully vested to 100%.

 

11. Benefits Upon Termination

A) If the Executive’s employment is terminated by the Company for Cause or by the Executive without Good Reason, the Company shall not be obligated to make any further payment to the Executive (other than accrued and unpaid base salary and expenses to the date of

 

13


termination), or continue to provide any benefit (other than benefits which have accrued pursuant to any plan or by law) to the Executive under this Agreement. Accrued and unpaid base salary, expenses, and benefits which have accrued pursuant to any plan or by law are hereinafter referred to as “Accrued Obligations”.

B) If the Executive is terminated for Performance Reasons, then, in addition to the Accrued Obligations, Executive shall be entitled to: (i) salary continuation at the salary the Executive was receiving at the time of termination for a period of six (6) months following termination; and (ii) upon timely election of COBRA continuation coverage, the Executive’s continued participation in any employee health and welfare benefit plan to which the Executive was a participant prior to his termination, with the Company premiums paid at the same percentage as when the Executive had participated as an employee, for up to six (6) months following termination; provided, that the Company’s obligation to continue the Executive’s participation in any employee health and welfare benefit plan shall case as of the date the Executive becomes eligible to participate in a similar benefit from another source. All payments shall begin as soon as practicable following the effective date of the separation agreement set forth in Section 11(E) below.

C) If the Executive’s employment is terminated by the Company for Disability, or without Cause, if employment terminates because of the Executive’s death, or if the Executive terminates his employment for Good Reason, then, in addition to the Accrued Obligations, Executive shall be entitled to: (i) salary continuation at the salary the Executive was receiving at the time of termination for a period of twelve (12) months following termination; and (ii) upon timely election of COBRA continuation coverage, the Executive’s continued participation in any employee health and welfare benefit plan to which the Executive was a participant prior to

 

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his termination, with the Company premiums paid at the same percentage as when the Executive had participated as an employee, for up to twelve (12) months following termination; provided, that the Company’s obligation to continue the Executive’s participation in any employee health and welfare benefit plan shall cease as of the date that the Executive becomes eligible to participate in a similar benefit from another source. All payments shall begin as soon as practicable following the effective date of the separation agreement set forth in Section 11(E) below.

D) Notwithstanding any other provision with respect to payments under Section 11(B), if the Executive’s employment is terminated by the Company within twelve (12) months of a Change of Control for reasons other than Cause, Disability, or his death or if the Executive terminates his employment for Good Reason within twelve (12) months of a Change of Control, then, in lieu of the payments set forth in paragraph (C), the Executive shall be entitled to (i) salary continuation at the salary the Executive was receiving at the time of termination for a period of twenty-four (24) months following termination; (ii) an amount equal to two times the Executive’s target annual bonus, paid in a lump sum; and (iii) upon timely election of COBRA continuation coverage, the Executive’s continued participation, subject to COBRA, in any employee health and welfare benefit plan to which the Executive was a participant prior to his termination, with the Company premiums paid at the same percentage as when the Executive had participated as an employee, for up to twenty-four (24) months following termination; provided that, if COBRA continuation coverage is otherwise earlier terminated under applicable law, then, in lieu of coverage, the Company will pay its share of the monthly Company premium in effect prior to the termination of COBRA continuation coverage directly to the Executive each month for the remainder of the relevant period. All payments shall begin as soon as practicable following the effective date of the separation agreement set forth in Section 11(E) below.

 

15


E) All payments and benefits set forth in Sections 11(B)-(D) are contingent upon the Executive’s execution (without revocation) of a separation agreement that is in a form acceptable to the Company and contains a full waiver and release of claims against the Company, within twenty-one (21) days of the date such separation agreement is provided to the Executive.

F) Notwithstanding any other provision with respect to the timing of payments under Sections 11(A)-(D), as applicable, if, at the time of the Executive’s termination, the Executive is deemed to be a “specified employee” (within the meaning of Code Section 409 A, and any successor statute, regulation and guidance thereto) of the Company, then only to the extent necessary to comply with the requirements of Code Section 409A, any payments to which the Executive may become entitled under Sections 11(A)-(D), as applicable, will be withheld until the first business day of the seventh month following the termination of the Executive’s employment, at which time the Executive shall be paid an aggregate amount equal to six months of payments otherwise due to the Executive under the terms of Sections 11(A)-(D), as applicable. After the first business day of the seventh month following the termination of the Executive’s employment and continuing each month thereafter, the Executive shall be paid the regular monthly payments otherwise due to the Executive in accordance with the terms of Sections 11(A)-(D), as applicable. In addition, in the event that the Company is obligated to make cash payments directly to the Executive in lieu of COBRA continuation coverage pursuant to the terms of Section 11(D), then, to the extent necessary to comply with the requirements of Code Section 409A, such cash payments will be withheld, if applicable, in the same manner as described above in this paragraph.

 

16


12. Arbitration

A) Any dispute under this Agreement, including any dispute as to cause or good reason for termination, shall be submitted to binding arbitration subject lo the rules of the American Arbitration Association. EACH OF THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVES THE RIGHT TO A TRIAL BY JURY IN ANY SUCH ACTIONS, SUIT OR PROCEEDING. The Company shall bear all costs associated with the Arbitration, including filing fees and any stipend for the arbitrator. The Company and the Executive shall each bear its own attorneys’ fees. However, if the Executive prevails in a challenge to the Company’s determination for cause, the Executive shall be entitled to be reimbursed for all attorney fees.

B) Nothing in this section shall be read to preclude the Company seeking injunctive relief for the Executive’s breach of Section 7, Proprietary and Trade Secret Information or Section 8, Covenant Not to Compete.

 

13. Injunctive Relief

The Executive acknowledges that the services rendered by him under this Agreement are of a special, unique and extraordinary character and, in connection with such services, he will have access to confidential information concerning the Company’s business. By reason of this access to confidential information, the Executive consents and agrees that if he violates any of the provisions of this Agreement with respect to Proprietary and Trade Secret Information or the Covenant Not to Compete, the Company would sustain irreparable harm and, therefore, in addition to any other remedies which the Company may have under this Agreement or otherwise, the Company shall be entitled to an injunction to be issued by any court of competent jurisdiction restraining the Executive from committing or continuing to commit any such violation of this Agreement.

 

17


14. Miscellaneous

A) This Agreement shall be governed by and construed in accordance with the laws of the State of Connecticut, applicable to agreements made and to be performed in Connecticut, and shall be construed without regard to any presumption or other rule requiring construction against the party causing the Agreement to be drafted.

B) This Agreement contains a complete statement of all the arrangements between the Company and the Executive with respect to its subject matter, supersedes all previous agreements, written or oral, among them relating to its subject matter and cannot be modified, amended or terminated orally. Amendments may be made to this Agreement at any time if mutually agreed upon in writing.

C) Any amendment, notice or other communication under this Agreement shall be in writing and shall be considered given when received and shall be delivered personally or mailed by Certified Mail, Return Receipt Requested, to the parties at their respective addresses set forth in this Agreement, or at such other address as a party may specify by written notice to the other.

D) The failure of a party to insist upon strict adherence to any term of this Agreement on any occasion shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement. Any waiver must be in writing.

E) Each of the parties irrevocably submits to the exclusive jurisdiction of any court of the State of Connecticut or the Federal District Court of Connecticut over any action, suit or proceeding relating to or arising out of this Agreement and the transactions contemplated hereby.

 

18


Each party hereby irrevocably waives any objections, including, without limitation, any objection to the laying of venue or based on the grounds of forum non conveniens which such party may now or hereafter have to the bringing of any such actions, suit or proceeding in any such court and irrevocably agrees that process in any such actions, suit or proceeding may be served upon that party personally or by Certified or Registered Mail, Return Receipt Requested.

F) The invalidity or unenforceability of any term or provision of this Agreement shall not affect the validity or enforceability of the remaining terms or provisions of this Agreement which shall remain in full force and effect and any such invalid or unenforceable term or provision shall be given full effect as is legally permissible. If any term or provision of this Agreement is invalid or unenforceable in one jurisdiction, it shall not affect the validity or enforceability of that term or provision in any other jurisdiction.

G) This Agreement is not assignable by either party except that it shall inure to the benefit of and be binding upon any successor to the Company by merger or consolidation or the acquisition of all or substantially all of the Company’s assets, provided such successor assumes all of the obligations of the Company, and shall inure to the benefit of the heirs and legal representatives of the Executive.

H) The Executive hereby acknowledges and agrees that the Company makes no representations or warranties regarding the tax treatment or tax consequences of any compensation, benefits or other payments under the Agreement, including, without limitation, by operation of Code Section 409A, or any successor statute, regulation and guidance thereto. Notwithstanding the foregoing, in the event it shall be determined that any payment, award, benefit or distribution by the Company to or for the benefit of the Executive would be subject to Section 280G of the Internal Revenue Code of 1986, as amended, (the “Code”) or the excise

 

19


tax imposed by Section 4999 of the Code or any corresponding provisions of state or local tax laws as a result of a payment to Executive upon a change of control, or any interest or penalties are incurred by Executive with respect to such excise tax (such excise tax, together with any such interest and penalties, are hereinafter collectively referred to as the “Excise Tax”), the Executive shall receive the greater of (i) the total value of the payments to be paid to Executive upon a change of control reduced to an amount that shall avoid triggering the Excise Tax or (ii) the total value of the payments to be paid to Executive upon a change in control with the application of the Excise Tax.

I) The Company and the Executive agree that they will negotiate in good faith and jointly execute an amendment to modify this Agreement to the extent necessary to comply with the requirements of Code Section 409A, or any successor statute, regulation and guidance thereto; provided that no such amendment shall increase the total financial obligation of the Company under this Agreement.

 

By:     /s/ Timothy M. Shannon        Dec 14, 2007           By:     /s/ Sean A. Cassidy       12/14/07
 

Timothy M. Shannon

President and Chief Executive Officer

CuraGen Corporation

322 East Main Street

Branford, CT 06405

(on behalf of “the Company”)

     

Sean A. Cassidy

VP and CFO

CuraGen Corporation

322 East Main Street

Branford, CT 06405

(“the Executive”)

 

Date

 

20


SCHEDULE A

Compensation

The Executive shall receive the following compensation for services during the initial term of employment:

 

  1) The Executive’s base salary shall be $175,000 per year, payable in bi-weekly installments, subject to increases by the Board of Directors, which shall review the salary periodically.

 

  2) The Executive, if otherwise eligible, shall participate in any incentive compensation plan, pension, profit sharing, stock purchase or stock option plan, annuity, or group insurance plan, medical plan and other benefits, maintained by the Company for its employees.

 

  3) The Executive shall be eligible to receive annual performance-based bonuses based on the attainment of goals set by the Chief Executive Officer. The Executive’s non-equity bonus shall be 25% of base salary at target.

 

21

EX-12.1 8 dex121.htm RATIO OF EARNINGS TO FIXED CHARGES Ratio of Earnings to Fixed Charges

Exhibit 12.1

CURAGEN CORPORATION AND SUBSIDIARY

RATIO OF EARNINGS TO FIXED CHARGES

(in thousands, except ratio data)

 

     Year Ended December 31,  
     2007     2006     2005     2004     2003  

Loss:

          

Loss from continuing operations before income tax benefit

   $ (50,148 )   $ (57,540 )   $ (69,571 )   $ (80,770 )   $ (65,580 )

Add: Fixed charges

     5,617       9,778       12,396       13,653       10,578  
                                        

Total loss

   $ (44,531 )   $ (47,762 )   $ (57,175 )   $ (67,117 )   $ (55,002 )
                                        

Fixed charges:

          

Interest expense on indebtedness (including amortization of financing costs)

   $ 5,167     $ 9,351     $ 11,701     $ 12,941     $ 9,845  

Estimated interest portion of rental expense

     450       427       695       712       733  
                                        

Total fixed charges

   $ 5,617     $ 9,778     $ 12,396     $ 13,653     $ 10,578  
                                        

Ratio of Earnings to Fixed Charges

     (7.93 )     (4.88 )     (4.61 )     (4.92 )     (5.20 )
                                        

Deficiency of Earnings Available to Cover Fixed Charges

   $ (50,148 )   $ (57,540 )   $ (69,571 )   $ (80,770 )   $ (65,580 )
                                        
EX-21.1 9 dex211.htm SUBSIDIARIES OF THE REGISTRANT Subsidiaries of the Registrant

Exhibit 21.1

SUBSIDIARIES OF THE REGISTRANT

NONE

EX-23.1 10 dex231.htm CONSENT OF DELOITTE & TOUCHE LLP Consent of Deloitte & Touche LLP

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in Registration Statements No. 333-56829, No. 333-89465, No. 333-108119 and No. 333-144440 on Form S-8, and Registration Statements No. 333-90321, No. 333-32756, No. 333-47600 and No. 333-113930 on Form S-3 of our report dated March 11, 2008 (which expresses an unqualified opinion and includes an explanatory paragraph related to the adoption of FIN 48 and SFAS No. 123(R)) relating to the financial statements of CuraGen Corporation and the effectiveness of CuraGen Corporation’s internal control over financial reporting appearing in this Annual Report on Form 10-K of CuraGen Corporation for the year ended December 31, 2007.

 

/s/ DELOITTE & TOUCHE LLP

Hartford, Connecticut

March 11, 2008

 

EX-31.1 11 dex311.htm CERTIFICATION BY CEO PURSUANT TO SECTION 302 Certification by CEO pursuant to Section 302

Exhibit 31.1

CERTIFICATION

I, Timothy M. Shannon, M.D., certify that:

 

1. I have reviewed this Annual Report on Form 10-K of CuraGen Corporation;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
      /s/    TIMOTHY M. SHANNON, M.D.        
Dated: March 11, 2008    

Timothy M. Shannon, M.D.

President and Chief Executive Officer

EX-31.2 12 dex312.htm CERTIFICATION BY CFO PURSUANT TO SECTION 302 Certification by CFO pursuant to Section 302

Exhibit 31.2

CERTIFICATION

I, Sean A. Cassidy, certify that:

 

1. I have reviewed this Annual Report on Form 10-K of CuraGen Corporation;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
      /s/    SEAN A. CASSIDY        
Dated: March 11, 2008    

Sean A. Cassidy

Vice President and Chief Financial Officer

EX-32.1 13 dex321.htm CERTIFICATION BY CEO AND CFO PURSUANT TO SECTION 906 Certification by CEO and CFO pursuant to Section 906

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report on Form 10-K of CuraGen Corporation (the “Company”) for the period ended December 31, 2007 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Timothy M. Shannon, M.D., President and Chief Executive Officer of the Company, and Sean A. Cassidy, Vice President and Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

      /s/    TIMOTHY M. SHANNON, M.D.        
Dated: March 11, 2008    

Timothy M. Shannon, M.D.

President and Chief Executive Officer

      /s/    SEAN A. CASSIDY        
Dated: March 11, 2008    

Sean A. Cassidy

Vice President and Chief Financial Officer

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-----END PRIVACY-ENHANCED MESSAGE-----