UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
   
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31,June 30, 2009
OR
   
o 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 000-23467
PENWEST PHARMACEUTICALS CO.
(Exact name of registrant as specified in its charter)
   
Washington
(State or other jurisdiction of
incorporation or organization)
 91-1513032
(I.R.S. Employer
Identification No.)
   
39 Old Ridgebury Road
Suite 11

Danbury, Connecticut
06810-5120

(Address of Principal Executive Offices)
 

06810-5120
(Zip Code)
(877) 736-9378
(Registrant’s telephone number, including area code)
     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 at least the past 90 days. Yesþ     Noo
     Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yeso     Noo
     Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer oAccelerated filer þ Non-accelerated filer o
(Do not check if a smaller reporting company)
Smaller reporting company o
     Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yeso     Noþ
     Indicate the number of shares outstanding of each of the issuer’s classes of common stock as of MayAugust 5, 2009.
   
ClassOutstanding

Common Stock, par value $.001
 31,735,442Outstanding
31,759,545
 
 

 


 

PENWEST PHARMACEUTICALS CO.
TABLE OF CONTENTS
       
    Page
       
     
    3 
    4 
    5 
    6 
       
   20
Quantitative and Qualitative Disclosures About Market Risk32
Controls and Procedures3221 
       
PART II — OTHER INFORMATION
Legal Proceedings3. 33
Risk Factors  35 
       
   4835
Item 1.36
Item 1A.38
Item 4.51
Item 6.52 
       
Signature  4953 
       
Exhibit Index  5054 
 Ex-10.1 RightsEX-10.1 Settlement Agreement dated as of March 11,May 5, 2009
Ex-10.2 Third Amendment, signed March 31, 2009, to the Amended and Restated Strategic Alliance Agreement, dated as of April 2, 2002
 EX-31 Section 302 Certification of CEO & CFOPrincipal Executive Officer and Principal Financial Officer
 Ex-32EX-32 Section 906 Certification of CEO & CFOPrincipal Executive Officer and Principal Financial Officer
     TIMERx®, Geminex® and SyncroDose® are our registered trademarks. GastroDose™ is also our trademark. Other tradenames and trademarks appearing in this quarterly report, including Endo Pharmaceuticals Inc.’s Opana® trademark, are the property of their respective owners.
Forward-looking Statements
     This quarterly report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included or incorporated in this report regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “projects,” “will,” “could,” “should,” “targets,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements. These important factors include those set forth below under “Part II — Item 1A, Risk Factors.” In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed herein may not occur, and our actual performance and results may vary from those anticipated or otherwise suggested by such statements. You are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements represent our estimates only as of the date this quarterly report is filed with the Securities and Exchange Commission (“SEC”) and should not be relied upon as representing our estimates as of any subsequent date. We do not assume any obligation to update any forward-looking statements and readers should not rely on those forward-looking statements as representing our views as of any date subsequent to the date of this quarterly report.

2


PART I — FINANCIAL INFORMATION
Item 1.Condensed Financial Statements (Unaudited)
PENWEST PHARMACEUTICALS CO.
CONDENSED BALANCE SHEETS
        
         June 30, December 31, 
 March 31, December 31,  2009 2008 
 2009 2008  (Unaudited) (Note 2) 
 (Unaudited) (Note 2)  (In thousands, 
 (In thousands,  except share amounts) 
 except share amounts)  
ASSETS
  
Current assets:  
Cash and cash equivalents $14,465 $16,692  $12,174 $16,692 
Marketable securities 500   500  
Trade accounts receivable 4,980 4,894  5,849 4,894 
Inventories — finished goods 265 440  216 440 
Prepaid expenses and other current assets 1,310 1,365  854 1,365 
          
Total current assets 21,520 23,391  19,593 23,391 
Fixed assets, net 2,019 2,177  1,835 2,177 
Patents, net 1,499 1,819  1,424 1,819 
Deferred charges 2,137 2,244  2,034 2,244 
Other assets, net 2,208 2,223  2,046 2,223 
          
Total assets $29,383 $31,854  $26,932 $31,854 
          
  
LIABILITIES AND SHAREHOLDERS’ EQUITY
  
Current liabilities:  
Accounts payable $1,388 $745  $851 $745 
Accrued expenses 1,734 1,695  1,953 1,695 
Accrued development costs 168 385  545 385 
Loan payable — current portion 5,483 5,483  5,483 5,483 
Deferred compensation — current portion 294 291  294 291 
          
Total current liabilities 9,067 8,599  9,126 8,599 
Loan payable 2,741 4,112  1,371 4,112 
Accrued financing fees 360 360  360 360 
Deferred revenue 267 473  959 473 
Deferred compensation 2,388 2,384  2,247 2,384 
          
Total liabilities 14,823 15,928  14,063 15,928 
Shareholders’ equity 
Shareholders’ equity: 
Preferred stock, par value $.001, authorized 1,000,000 shares, none outstanding      
Common stock, par value $.001, authorized 60,000,000 shares, issued and outstanding 31,719,442 shares at March 31, 2009 and 31,697,250 shares at December 31, 2008 32 32 
Common stock, par value $.001, authorized 60,000,000 shares, issued and outstanding 31,757,009 shares at June 30, 2009 and 31,697,250 shares at December 31, 2008 32 32 
Additional paid in capital 248,858 249,262  249,305 249,262 
Accumulated deficit  (234,589)  (233,627)  (236,727)  (233,627)
Accumulated other comprehensive income 259 259  259 259 
          
Total shareholders’ equity 14,560 15,926  12,869 15,926 
          
Total liabilities and shareholders’ equity $29,383 $31,854  $26,932 $31,854 
          
See accompanying notes to condensed financial statements

3


PENWEST PHARMACEUTICALS CO.
CONDENSED STATEMENTS OF OPERATIONS
        
 Three Months Ended                 
 March 31,  Three Months Ended Six Months Ended 
 2009 2008  June 30, June 30, 
 (Unaudited)  2009 2008 2009 2008 
 (In thousands, except  (Unaudited) 
 per share data)  (In thousands, except per share data) 
  
Revenues:  
Royalties $4,722 $422  $4,851 $537 $9,573 $959 
Product sales 180 228  158 302 338 530 
Collaborative licensing and development revenue 368 89  250 477 618 566 
              
Total revenues 5,270 739  5,259 1,316 10,529 2,055 
  
Operating expenses:  
Cost of revenues 654 169  468 508 1,122 677 
Selling, general and administrative 2,321 4,324  3,283 3,071 5,604 7,395 
Research and product development 3,006 6,385  3,425 4,524 6,431 10,909 
              
Total operating expenses 5,981 10,878  7,176 8,103 13,157 18,981 
              
Loss from operations  (711)  (10,139)  (1,917)  (6,787)  (2,628)  (16,926)
  
Investment income 7 200  4 180 11 379 
Interest expense  (258)  (358)  (225)  (321)  (483)  (678)
              
Loss before income tax expense  (962)  (10,297)  (2,138)  (6,928)  (3,100)  (17,225)
  
Income tax expense        
              
 
Net loss $(962) $(10,297) $(2,138) $(6,928) $(3,100) $(17,225)
              
  
Basic and diluted net loss per common share $(0.03) $(0.41) $(0.07) $(0.22) $(0.10) $(0.61)
              
  
Weighted average shares of common stock outstanding — basic and diluted 31,719 25,113  31,644 31,486 31,635 28,299 
              
See accompanying notes to condensed financial statements

4


PENWEST PHARMACEUTICALS CO.
CONDENSED STATEMENTS OF CASH FLOWS
                
 Three months Ended  Six months Ended 
 March 31,  June 30, 
 2009 2008  2009 2008 
 (Unaudited)  (Unaudited) 
 (In thousands)  (In thousands) 
Operating activities:  
Net loss $(962) $(10,297) $(3,100) $(17,225)
Adjustments to reconcile net loss to net cash used in operating activities 651 1,809  1,607 2,169 
          
Net cash used in operating activities  (311)  (8,488)  (1,493)  (15,056)
  
Investing activities:  
Acquisitions of fixed assets  (12)  (22)  (16)  (31)
Patent costs  (34)  (96)  (34)  (201)
Proceeds from sale of fixed assets 6  
Reimbursements of patent costs by collaborator 229  
Proceeds from maturities of marketable securities  9,800 
Purchases of marketable securities  (499)  (2,531)  (499)  (7,859)
Proceeds from maturities of marketable securities  4,650 
Loan disbursed to collaborator   (1,000)   (1,000)
          
Net cash (used in) provided by investing activities  (545) 1,001   (314) 709 
  
Financing activities:  
Repayment of debt  (1,371)  (601)  (2,741)  (1,202)
Issuance of common stock, net  25,093  30 23,187 
          
Net cash (used in) provided by financing activities  (1,371) 24,492   (2,711) 21,985 
      
 
Net (decrease) increase in cash and cash equivalents  (2,227) 17,005   (4,518) 7,638 
Cash and cash equivalents at beginning of period 16,692 15,680  16,692 15,680 
          
Cash and cash equivalents at end of period $14,465 $32,685  $12,174 $23,318 
          
See accompanying notes to condensed financial statements

5


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Business
     Penwest Pharmaceuticals Co. (“Penwest” or the “Company”) is a drug development company focused on identifying and developing products that address unmet medical needs, primarily for rare disorders of the nervous system. The Company is currently developing A0001, or alpha tocopherol quinone, a coenzyme Q analog drug candidate that it licensed from Edison Pharmaceuticals, Inc. (“Edison”) for inherited mitochondrial respiratory chain diseases. The Company is also applying its drug delivery technologies and drug formulation expertise to the formulation of product candidates under licensing collaborations (“drug delivery technology collaborations”).
     Opana®Opana® ER is an extended release formulation of oxymorphone hydrochloride that the Company developed with Endo Pharmaceuticals Inc. (“Endo”) using the Company’s proprietary TIMERx®TIMERx® drug delivery technology. Opana ER was approved by the United States Food and Drug Administration (“FDA”) in June 2006 for twice-a-day dosing in patients with moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time and is being marketed by Endo in the United States. In the threesix months ended March 31,June 30, 2009, the Company recognized $4.4$8.8 million in royalties from Endo related to sales of Opana ER.
     The Company is currently developing A0001 a drug candidate that will be initially targeted for the treatment of inherited mitochondrial respiratory chain diseases, under a collaboration and license agreement with Edison that the Company entered into in July 2007 (the(as amended, the “Edison Agreement”). The Company is currently conducting a Phase Ib multiple ascending dose safety study in healthy volunteers. If A0001 demonstrates an acceptable safety profile and tolerability in this Phase Ib study, we plan to commence a Phase IIa trial in patients with inherited mitochondrial respiratory chain diseases in the second half of 2009. The goal of this trial will be to determine if A0001 has biological activity. Under the Edison Agreement, the Company has agreed to collaborate with Edison on the development of A0001 and up to one additional drug candidate of Edison’s. In June 2009, the Company completed a Phase Ib multiple ascending dose safety study in healthy subjects. In the Phase Ib trial, the drug was well tolerated by subjects and no serious adverse events were reported. In addition, the Company observed a dose-dependent increase in exposure approaching steady state within two to four days following repeat dosing, and was able to establish a maximum tolerated dose. Based on these results, the Company plans to advance A0001 into Phase IIa studies in patients with mitochondrial diseases in the fourth quarter of 2009. The Company intends to commence two Phase IIa trials — one trial focused on patients with Friedreich’s Ataxia and another trial focused on patients with the A3243G mitochondrial DNA point mutation associated with MELAS syndrome. The goal of these trials will be to determine if A0001 has biological activity. The Company expects data from both of these trials in the first half of 2010.
     The Company is a party to a number of collaborations involving the use of its extended release drug delivery technologies as well as its formulation development expertise. Under these collaborations, the Company is responsible for completing the formulation work on a product specified by ourits collaborator. If the Company is successful, the formulation is transferred to its collaborator, who is responsible for the completion of the clinical development, and ultimately the commercialization of the product. Under the terms of these agreements, the Company generally receives up-frontupfront fees, reimbursement of research and development costs incurred, up to amounts specified in each agreement, and potential milestone payments upon the achievement of specified events. These agreements also provide for the Company to receive payments from the sale of bulk TIMERx material and royalties on product sales upon commercialization of the product. The Company is seeking to enter into additional drug delivery technology collaborations.
2. Basis of Presentation
     The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation for the interim periods presented have been included. All such adjustments are of a normal recurring nature, except forfor: a charge recorded in the three month period ended March 31, 2009 in the amount of $550,000 for severance costs associated with staff reductions implemented in January 2009,2009; a non-cash credit recorded in the three month period ended March 31, 2009 in the amount of $885,000 associated with the forfeiture of stock options held by these former employees (see Note 9); and a charge recorded in the three month period ended March 31, 2008 in the amount of $1.0 million to establish a reserve against a loan receivable from Edison (see Note 13). In addition, in connection with the Company’s proxy contest and the related litigation (see Note 14), the Company incurred costs approximating $1.1 million and $1.3 million for the three and six month periods ended June 30, 2009, respectively. Operating results for the three and six month period

6


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
periods ended March 31,June 30, 2009 are not necessarily indicative of the results that may be expected for the year ending December 31, 2009. For further information, refer to the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.
     The balance sheet at December 31, 2008 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.

6


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     Certain prior year amounts have been reclassified to conform to the current year presentation. These reclassifications had no impact on the Company’s financial position or results of operations.
     During the three and six month periodperiods ended March 31,June 30, 2009, there were no significant changes in the Company’s significant accounting policies as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2008.
3. Recent Accounting Pronouncements
     In December 2007, the Financial Accounting Standards Board’s (“ FASB”) Emerging Issues Task Force (“EITF”) reached a consensus on Issue No. 07-1, “Accounting for Collaborative Arrangements” (“EITF No. 07-1”). The EITF concluded on the definition of a collaborative arrangement, and that revenues and costs incurred with third parties in connection with collaborative arrangements would be presented on a gross or net basis based on the criteria in EITF No. 99-19 and other accounting literature. Based on the nature of the arrangement, payments to or from collaborators would be evaluated, and the arrangement’s terms, the nature of the entity’s business, and whether those payments are within the scope of other accounting literature would be presented. Companies are also required to disclose the nature and purpose of collaborative arrangements, along with the accounting policies, and the classification and amounts of significant financial statement amounts related to the arrangements. Activities in the arrangement conducted in a separate legal entity should be accounted for under other accounting literature; however, required disclosure under EITF No. 07-1 applies to the entire collaborative agreement. EITF No. 07-1 is effective for fiscal years beginning after December 15, 2008 and is to be applied retrospectively to all periods presented for all collaborative arrangements existing as of the effective date. The Company’s adoption of the provisions of EITF No. 07-1 as of January 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In April 2008, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 142-3, “Determination of the Useful Life of Intangible Assets” (“SFAS No. 142-3”). In determining the useful life of intangible assets, SFAS No. 142-3 removes the requirement to consider whether an intangible asset can be renewed without substantial cost or material modifications to the existing terms and conditions and, instead, requires an entity to consider its own historical experience in renewing similar arrangements. SFAS No. 142-3 also requires expanded disclosure related to the determination of intangible asset useful lives. SFAS No. 142-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008. The Company’s adoption of the provisions of SFAS No. 142-3 as of January 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In June 2008, the EITF reached a consensus on Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock (“EITF No. 07-5”). EITF No. 07-5 was issued to clarify how to determine whether certain instruments or features are indexed to an entity’s own stock under EITF Issue No. 01-6, “The Meaning of Indexed to a Company’s Own Stock” (“EITF No. 01-6”). The consensus in EITF No. 07-5 applies to any freestanding financial instrument or embedded feature that has the characteristics of a derivative as defined in FSP No. SFAS 133, “Accounting for Derivative Instruments and Hedging Activities” (“SFAS 133”). The consensus in EITF No. 07-5 as of January 1, 2009, supersedes EITF No. 01-6 and is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. The Company’s adoption of EITF No. 07-5 as of January 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In June 2008, the FASB issued FSPFASB Staff Position (“FSP”) EITF 03-6-1, “Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities” (“EITF No. 03-6-1”). EITF No. 03-6-1

7


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
provides that unvested share-based payment awards that contain nonforfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are participating securities and shall be included in the computation of earnings per share pursuant to the two-class method. Upon adoption, a company is required to retrospectively adjust its earnings per share data (including any amounts related to interim periods, summaries of earnings and selected financial data) to conform with the provisions in EITF No. 03-6-1. The Company determined that its unvested restricted stock is a participating security under EITF No. 03-6-1. EITF No. 03-6-1 is effective for fiscal years beginning after December 15, 2008, including interim periods within those fiscal years. The Company’s adoption of EITF No. 03-6-1 as of January 1,

7


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
2009 had no impact on the earnings per share calculations for the three and six month periods ended March 31,June 30, 2009 and March 31, 2008.the three and six month periods ended June 30, 2008 due to the Company’s net losses in such periods.
     In October 2008, the FASB issued SFAS No. 157-2, “Effective Date of FASB No. 157” (“SFAS No. 157-2”). SFAS No. 157-2 delayed the effective date of SFAS No. 157 to fiscal years beginning after November 15, 2008, and interim periods within those fiscal years, for nonfinancial assets and nonfinancial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). The Company’s adoption of this pronouncement as of January 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In April 2009, the FASB issued FSP FAS 107-1 and Accounting Principles Board (“APB”) 28-1, “Interim Disclosures about Fair Value of Financial Instruments.” This FSP amends SFAS No. 107, “Disclosures About Fair Value of Financial Instruments,” to require disclosures about fair value of financial instruments for interim reporting periods of publicly traded companies as well as in annual financial statements. This FSP also amends APB Opinion No. 28, “Interim Financial Reporting,” to require those disclosures in summarized financial information at interim reporting periods. This FSP is effective for interim reporting periods ending after June 15, 2009, with early adoption permitted for periods ending after March 15, 2009. The FSP does not require disclosures for earlier periods presented for comparative purposes at initial adoption. In periods after initial adoption, this FSP requires comparative disclosures only for periods ending after initial adoption. The Company is currently evaluating the effect, if any, theCompany’s adoption of this FSP willpronouncement as of April 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, “Recognition and Presentation of Other-Than-Temporary Impairments.” This FSP amends the other-than-temporary impairment guidance for debt securities to make the guidance more operational and to improve the presentation and disclosure of other-than-temporary impairments on debt and equity securities in the financial statements. This FSP does not amend existing recognition and measurement guidance related to other-than-temporary impairments of equity securities. This FSP is effective for interim and annual reporting periods ending after June 15, 2009, with early adoption permitted for periods ending after March 15, 2009. The FSP does not require disclosures for earlier periods presented for comparative purposes at initial adoption. In periods after initial adoption, this FSP requires comparative disclosures only for periods ending after initial adoption. The Company’s adoption of this pronouncement as of April 1, 2009 did not have a material effect on its results of operations, financial position or cash flows.
     In May 2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS No. 165”). This Statement incorporates guidance into accounting literature that was previously addressed only in auditing standards. The Statement refers to subsequent events that provide additional evidence about conditions that existed at the balance-sheet date as “recognized subsequent events.” Subsequent events which provide evidence about conditions that arose after the balance sheet date but prior to the issuance of the financial statements are referred to as “non-recognized subsequent events.” SFAS No. 165 also requires companies to disclose the date through which subsequent events have been evaluated and whether this date is the date the financial statements were issued or the date the financial statements were available to be issued. SFAS No. 165 is effective for interim or annual periods ending after June 15, 2009 and is to be applied prospectively. The Company adopted SFAS No. 165 effective with its financial reporting for the three months ended June 30, 2009 (see Note 15).
     In June 2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles — a replacement of FASB Statement No. 162” (“SFAS No. 168”). The FASB Accounting Standards Codification is currently evaluatingintended to be the effect, if any,source of authoritative U.S. generally

8


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
accepted accounting principles (GAAP) and reporting standards as issued by the FASB. Its primary purpose is to improve clarity and use of existing standards by grouping authoritative literature under common topics. This Statement is effective for financial statements issued for interim and annual periods ending after September 15, 2009. The Codification does not change or alter existing GAAP for public companies. The Company does not expect that the adoption of this FSPSFAS No. 168 will have a material effect on its results of operations, financial position or cash flows.
     Other pronouncements issued by the FASB or other authoritative accounting standards groups with future effective dates are either not applicable or not significant to the financial statements of the Company.
4. Fair Value Measurement
     In January 2008, the Company adopted the methods of fair value as described in SFAS No. 157 to value its financial assets and liabilities. As defined in SFAS No. 157, fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, SFAS No. 157 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

8


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well aspossible; the Company also considers counterparty credit risk in its assessment of fair value.
Financial assets and liabilities measured at fair value on a recurring basis as of March 31,June 30, 2009 are classified in the table below in one of the three categories described above:
                
 Level 1 Level 2 Level 3 Total                 
 (Unaudited) (In thousands)  Level 1 Level 2 Level 3 Total 
  (Unaudited) (In thousands) 
Cash and cash equivalents $14,465 $ $ $14,465  $12,174 $ $ $12,174 
Corporate debt securities  500  500   500  500 
                  
Total $14,465 $500 $ $14,965  $12,174 $500 $ $12,674 
                  
The corporate debt securities noted above matured in July 2009.
5. Other Assets
     Other assets are comprised of the following:
                
 March 31, December 31,  June 30, December 31, 
 2009 2008  2009 2008 
 (Unaudited) (In thousands)   
  (Unaudited) (In thousands) 
Assets held in a trust for the Company’s Supplemental Executive Retirement Plan and Deferred Compensation Plan (see Note 11):  
Cash surrender value of life insurance policies $1,946 $1,924  $1,969 $1,924 
Money market account 262 299  77 299 
          
 2,208 2,223  2,046 2,223 
  
Loan receivable from collaborator (see Note 13) 1,000 1,000  1,000 1,000 
          
 3,208 3,223  3,046 3,223 
Allowance for loan receivable from collaborator  (1,000)  (1,000)  (1,000)  (1,000)
          
Other assets, net $2,208 $2223  $2,046 $2,223 
          

9


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
6. Loan Payable
Credit Facility
     On March 13, 2007, the Company entered into a $24.0 million senior secured credit facility (the “Credit Facility”) with Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., which was acquired by GE Capital in February 2008, and is now known as GE Business Financial Services Inc. The Credit Facility consists of: (i) a $12.0 million term loan advanced upon the closing of the Credit Facility and (ii) a $12.0 million term loan that the Company had the right to access until September 15, 2008, subject to conditions specified in the credit agreement. The Company did not access the second $12.0 million term loan prior to September 15, 2008, at which time it expired in accordance with the terms of the agreement.
     In connection with the Credit Facility, the Company granted the lender a perfected first priority security interest in all existing and after-acquired assets of the Company, excluding: (i) its intellectual property, which is subject to a negative pledge; (ii) royalty payments from Mylan Pharmaceuticals Inc. (“Mylan”) on theirits sales of Pfizer Inc.’s (“Pfizer”) generic version of Procardia XL 30 mg, if the Company pledges such royalty payments to another lender; (iii) up to $3.0 million of equipment which the Company may, at its election, pledge to another lender in connection with an equipment financing facility separate from the Credit Facility; and (iv) the assets of the Company’s trust described in Note 11. In addition, the Company is precluded from paying cash dividends to its shareholders during the term of the Credit Facility. The outstanding term loan has a term of 42 months from the date of advance of March 13, 2007, with interest-only2007. Interest-only payments were due for the first nine months; interest plus monthly principal payments equal to 1.67% of the loan amount were due for the period from the end of the interest-only period through December 2008; and interest plus straight-line amortization payments with respect to the remaining principal balance are due for the remainder of the term, through its maturity date in September 2010.

9


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     The interest rate of the outstanding term loan is fixed at 10.32%. At the time of the final payment of the loan under the Credit Facility, the Company will pay an exit fee of 3.0% of the original principal loan amount. Should any prepayment occur, the Company is alsowould be required to pay a prepayment penaltiespenalty of 3.0% of any prepaid amount in the first year, 2.0% of any prepaid amount in the second year and 1.0% of any prepaid amount thereafter.amount.
     As of March 31,June 30, 2009, principal payments due on the outstanding principal of $8.2$6.9 million under the Credit Facilityterm loan are as follows:
        
 (Unaudited)  (Unaudited) 
 (In thousands)  (In thousands) 
Less than one year $5,483  $5,483 
One to two years 2,741  1,371 
      
 $8,224  $6,854 
      
     The Company accrued an exit fee as noted above of $360,000 in connection with the $12.0 million term loan advanced upon the closing of the Credit Facility. These costs, as well as other debt issuance costs incurred by the Company in securing the Credit Facility, were deferred and are included in deferred charges in the Company’s condensed balance sheets as of March 31,June 30, 2009 and December 31, 2008. These costs are being amortized over the term of the loan with such amortization included in interest expense in the Company’s condensed statements of operations.
7. Shareholders’ Equity
On September 26, 2008, the Company filed a registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”), which became effective on October 30, 2008. This shelf registration statement covers the issuance and sale by the Company of any combination of common stock, preferred stock, debt securities and warrants having an aggregate purchase price of up to $75 million. The shelf registration statement is a replacement of the registration statement filed in July 2005 that was to expire in December 2008. As of May 5,August 10, 2009, no securities have been issued under the registration statement.

10


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
Private Placement
     On March 11, 2008, the Company sold units representing an aggregate of 8,140,600 shares of its Common Stock, together with warrants to purchase an aggregate of 4,070,301 shares of its Common Stock, in a private placement, for a total purchase price of approximately $25.1 million. The Company received net proceeds of approximately $23.1 million from this private placement, after deducting the placement agent’s fees and other expenses.
     The warrants are exercisable on or prior to March 11, 2013 at an exercise price of $3.62 per share. The warrants may also be exercised under certain circumstances pursuant to cashless exercise provisions.
     Pursuant to the securities purchase agreement entered into in connection with the private placement, the Company filed a registration statement with the SEC on April 10, 2008, registering for resale the shares and shares issuable under the warrants. The registration statement was declared effective by the SEC on April 28, 2008. The Company has agreed to use its reasonable best efforts to maintain the registration statement’s effectiveness until the earlier of (i) the later of (A) March 11, 2009, or (B) the twelve monthtwelve-month anniversary of the last date on which warrant shares are issued upon exercise of warrants and (ii) the date all of the shares and warrant shares have been resold by the original purchasers.

10


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
Share-Based Compensation
     The Company recognized share-based compensation in its statements of operations as follows:
                
         Three Months Ended Six Months Ended 
 Three Months Ended  June 30, June 30, 
 March 31,  2009 2008 2009 2008 
 2009 2008   
 (Unaudited) (In thousands)  (Unaudited) (In thousands) 
Selling, general and administrative $(568) $681  $266 $526 $(302) $1,207 
Research and product development 164 234  151 215 315 450 
              
Total $(404) $915  $417 $741 $13 $1,657 
              
     The decrease in total share-based compensation expense in the three month period ended March 31,June 30, 2009, as compared towith the three month period ended March 31,June 30, 2008, is primarily attributable to lower average fair values associated with outstanding stock options and restricted stock in the 2009 three month period, as a result of decreases in the market price of the Company’s common stock, and a reduction in the number of outstanding stock options in the 2009 three month period, as a result of the forfeiture of employee stock options in the first quarter of 2009 due to the January 2009 staff reductions (see Note 9).
     The decrease in total share-based compensation expense in the six month period ended June 30, 2009, compared with the six month period ended June 30, 2008, is primarily attributable to credits of approximately $885,000 recorded in the first quarter of 2009 three month period under SFAS No. 123R associated with the forfeiture of employee stock options as a result ofdue to the January 2009 staff reductions (see Note 9). Such forfeitures also resulted in decreased expense in the 2009 six month period due to the reduction in the number of outstanding stock options in such period. The decrease was also partially attributable to lower average fair values associated with outstanding stock options and restricted stock in the 2009 threesix month period, primarily as a result of decreases in the market price of the Company’s common stock.
Rights Plan8. Cost of Revenues
     On March 11, 2009, the Company adopted a rights plan pursuant to which it issued a dividend of one preferred share purchase right for each share of common stock held by Company stockholders of record on March 23, 2009. Each right entitles Company shareholders to purchase one one-thousandth of a share of the Company’s Series A Junior Participating Preferred Stock at a price of $12.50, subject to adjustment under certain circumstances.
     The rights issued under the rights plan automatically trade with the underlying Company common stock, and are initially not exercisable. If a person acquires or commences a tender offer for 15% or more of the Company’s common stock (or (A) in the case of Perceptive Life Sciences Master Fund Ltd. and its affiliates and associated persons (“Perceptive”), the greater of (x) 21% or (y) that percentage which Perceptive beneficially owned of the common stock outstanding as of the close of business on March 11, 2009 (the “Perceptive Percentage”), or (B) in the case of Tang Capital Management, LLC and its affiliates and associated persons (“Tang”), the greater of (x) 22% or (y) that percentage which Tang beneficially owned of the common stock outstanding as of the close of business on March 11, 2009 (the “Tang Percentage”) in a transaction that was not approved by the Company’s Board of Directors, each right, other than those owned by the acquiring person, will entitle the holder to purchase $25.00 worth of common stock for a $12.50 exercise price. If the Company is involved in a merger or other transaction with another company that is not approved by its Board of Directors, in which the Company is not the surviving corporation or which transfers more than 50% of its assets to another company, then each right, other than those owned by the acquiring person, will instead entitle the holder to purchase $25.00 worth of the acquiring company’s common stock for a $12.50 exercise price. If at any time Perceptive or Tang cease to beneficially own at least 15% of the Company’s common stock outstanding, the Perceptive Percentage or the Tang Percentage, as the case may be, will no longer be applicable and such shareholder will be subject to the same 15% thresholds as other shareholders.
     The Company’s Board of Directors may redeem the rights for $0.001 per right at any time until ten business days after a person acquires 15% (or in the case of Perceptive or Tang, the Perceptive Percentage or the Tang Percentage, as applicable) of the Company’s common stock, or on the date on which any executive officer of the Company has actual knowledge of such acquisition, whichever is later. The rights will expire upon the close of business on the earlier of (1) March 11, 2019 or (2) July 1, 2010, if the Company’s shareholders do not approve the rights plan by that date.
                 
  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2009  2008  2009  2008 
  (Unaudited) (In thousands) 
Cost of royalties $95  $45  $207  $65 
Cost of product sales  143   103   325   181 
Cost of collaborative licensing and development revenue  230   360   590   431 
             
Total cost of revenues $468  $508  $1,122  $677 
             

11


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
8. Cost of Revenues
         
  Three Months Ended 
  March 31, 
  2009  2008 
  (Unaudited) 
  (In thousands) 
Cost of royalties $113  $21 
Cost of product sales  181   77 
Cost of collaborative licensing and development revenue  360   71 
       
Total cost of revenues $654  $169 
       
     Cost of royalties consists of the amortization of deferred royalty termination costs and the amortization of certain patent costs associated with the Company’s TIMERx technology. Cost of product sales consists of the costs related to sales of formulated TIMERx material to the Company’s collaborators. Cost of collaborative licensing and development revenues consists of the Company’s expenses under its research and developmentdrug delivery technology collaboration agreements involving the development of product candidates using the Company’s TIMERx technology, and includes internal costs and outside contract services.
9. Staff Reductions
     In January 2009, the Company implemented staff reductions of approximately 18% of its workforce as part of its efforts to aggressively manage its overhead cost structure. The terms of the severance arrangements include severance pay and continuation of certain benefits, including medical insurance, over the respective severance periods. In connection with these staff reductions, the Company recorded a severance charge in its statement of operations for the three month period ended March 31, 2009 in the amount of $550,000, of which $355,000$117,000 was unpaid as of March 31,June 30, 2009 but will be paid over the remainder of 2009. Of such severance charge, $464,000 and $86,000 were recorded as selling, general and administrative expense, and research and development expense, respectively. In addition, as a result of these terminations, for the three month period ended March 31, 2009, the Company recorded a non-cash credit of approximately $885,000 under SFAS No. 123R associated with the forfeiture of stock options held by these former employees. Of such amount, $844,000 and $41,000 were recorded as credits to selling, general and administrative expense, and research and development expense, respectively.
10. Income Taxes
     The Company’s effective tax rates for the three and six month periods ended March 31,June 30, 2009 and 2008 were zero. The effective tax rates differ from the federal statutory rate of a 34% benefit primarily due to valuation allowances recorded to offset deferred tax assets relating to the Company’s net operating losses.
11. Supplemental Executive Retirement Plan and Deferred Compensation Plan
     The Company has a Supplemental Executive Retirement Plan (the “SERP”), a nonqualified plan, which covers the former Chairman and Chief Executive Officer of Penwest, Tod R. Hamachek. Under the SERP, the Company is obligated to pay Mr. Hamachek approximately $12,600 per month over the lives of Mr. Hamachek and his spouse. The actuarially determined liability for the SERP was approximately $1,967,000$1,959,000 and $1,975,000 as of March 31,June 30, 2009 and December 31, 2008, respectively, including the current portion of approximately $147,000 at March 31,June 30, 2009, and is included in deferred compensation in the Company’s condensed balance sheets. The Company has not funded this liability and no assets are held by the SERP. The Company uses a measurement date of December 31 for its SERP. The following disclosures summarize information relating to the SERP:

12


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
Components of net periodic benefit cost:
                        
 Three Months Ended  Three Months Ended Six Months Ended 
 March 31,  June 30, June 30, 
 2009 2008  2009 2008 2009 2008 
 (Unaudited) (In thousands)  (Unaudited) (In thousands) 
Interest cost $30 $29  $30 $30 $60 $59 
Amortization of prior service cost  1   (1)   (1) 1 
              
Net periodic benefit cost $30 $30  $29 $30 $59 $60 
              
     In addition, the Company has a Deferred Compensation Plan (the “DCP”), a nonqualified plan which covers Mr. Hamachek. Under the DCP, the Company recognized interest expense of $15,000$13,000 and $16,000$14,000 for the three month periods ended March 31,June 30, 2009 and 2008, respectively and $28,000 and $30,000 for the six month periods ended June 30, 2009 and 2008, respectively. The liability for the DCP was approximately $715,000$582,000 and $700,000 as of March 31,June 30, 2009 and December 31, 2008, respectively, including the current portion of approximately $147,000 at March 31,June 30, 2009, and is included in deferred compensation on the Company’s condensed balance sheets. The Company has not funded this liability and no assets are held by the DCP. In connection with the resignation and retirement of Mr. Hamachek, under the DCP, effective in May 2005, the Company commenced the payment of benefits to Mr. Hamachek, which are to be paid in ten annual installments, each approximating $140,000; however, these installments are recalculated annually based on market interest rates, as provided for under the DCP.

12


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     The Company has two whole-life insurance policies held in a rabbi trust (the “Trust”), the cash surrender value or death benefits of which are held in trust for the SERP and DCP liabilities. Mr. Hamachek’s SERP and DCP benefit payments are being made directly from the assets in the Trust. The cash surrender value of these life insurance policies totaled $1,946,000$1,969,000 as of March 31,June 30, 2009 and $1,924,000 as of December 31, 2008. Trust assets, including $262,000$77,000 and $299,000 held in a money market account at March 31,June 30, 2009 and December 31, 2008, respectively, are included in other assets in the Company’s condensed balance sheets.
12. Comprehensive Income (Loss)
     Accumulated other comprehensive income consists of the following:
         
  March 31,  December 31, 
  2009  2008 
  (Unaudited) 
  (In thousands) 
Adjustment for funded status of post retirement plan $259  $259 
       
         
  June 30,  December 31, 
  2009  2008 
  (Unaudited) (In thousands) 
Adjustment for funded status of post retirement plan $259  $259 
       
     The components of comprehensive loss are as follows:
        
 Three Months Ended                 
 March 31,  Three Months Ended Six Months Ended 
 2009 2008  June 30, June 30, 
 (Unaudited)  2009 2008 2009 2008 
 (In thousands)  (Unaudited) (In thousands) 
Net loss $(962) $(10,297) $(2,138) $(6,928) $(3,100) $(17,225)
Changes in unrealized net gains and losses on marketable securities  5    (8)   (3)
Adjustment for funded status of post retirement plan  1   (1)   (1) 1 
              
Comprehensive loss $(962) $(10,291) $(2,139) $(6,936) $(3,101) $(17,227)
              
13. Collaborative and Licensing Agreements
     The Company enters into collaborative and licensing agreements with pharmaceutical companies to in-license, develop, manufacture and/or market products that fit within its business strategy or to perform research and development for collaborators utilizing the Company’s drug delivery technology and formulation expertise.
Endo Pharmaceuticals Inc.
     In September 1997, the Company entered into a strategic alliance agreement with Endo with respect to the development of Opana ER, an extended release formulation of oxymorphone hydrochloride using the Company’s TIMERx technology. This agreement was amended and restated in April 2002, and was further amended in January 2007, July 2008 and March 2009, as described below.

13


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     Under the agreement, the Company agreed to supply bulk TIMERx material to Endo, the selling price of which is contractually determined and may be adjusted annually, and Endo agreed to manufacture and market Opana ER in the United States. The Company also agreed with Endo that any development and commercialization of Opana ER outside the United States would be accomplished through licensing to third parties approved by both Endo and the Company, and that the Company and Endo would divide equally any fees, royalties, payments or other revenue received by the parties in connection with such licensing activities. The Company is currently seeking licensing opportunities for Opana ER in territories outside the United States.
     Under the terms of the agreement:
  Endo has agreed to pay the Company royalties on U.S. sales of Opana ER calculated based on a royalty rate starting at 22% of annual net sales of the product up to $150 million of annual net sales, with the royalty rate then increasing, based on agreed-upon levels of annual net sales achieved, from 25% up to a maximum of 30%.
 
  No royalty payments were due to the Company for the first $41 million of royalties that would otherwise have been payable beginning from the time of the product launch in July 2006 (the “Royalty Holiday”). In the third quarter of 2008, this Royalty Holiday ended. The Company recognized royalties from Endo related to sales of Opana ER in the amount of $4.4$8.8 million for the threesix month period ended March 31,June 30, 2009.
The Company’s share of the development costs for Opana ER that it opted out of funding in April 2003 totaled $28 million and will be recouped by Endo through a temporary 50% reduction in royalties. Commencing in the third quarter of 2008, the Company began to receive reduced royalty payments from Endo, with such temporary reductions to continue until the $28 million is fully recouped. As of March 31, 2009, $9.4 million of the $28 million has been recouped by Endo.
Endo will pay the Company a percentage of any sublicense income it receives and milestone payments of up to $90 million based upon the achievement of agreed-upon annual net sales thresholds. The Company has not received any additional payments under this provision through March 31, 2009.

13


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
The Company’s share of the development costs for Opana ER that it opted out of funding in April 2003 totaled $28 million and will be recouped by Endo through a temporary 50% reduction in royalties. Commencing in the third quarter of 2008, the Company began to receive reduced royalty payments from Endo, with such temporary reductions to continue until the $28 million is fully recouped. As of June 30, 2009, $13.8 million of the $28 million has been recouped by Endo.
Endo will pay the Company a percentage of any sublicense income it receives and milestone payments of up to $90 million based upon the achievement of agreed-upon annual net sales thresholds.
     The Company and Endo entered into a Second Amendment to the Amended and Restated Strategic Alliance Agreement with respect to Opana ER, effective July 14, 2008. Under the terms of this amendment, Endo agreed to directly reimburse the Company for costs and expenses incurred by the Company in connection with patent enforcement litigation costs related to Opana ER. If any of such costs and expenses are not reimbursed to the Company by Endo, the Company may bill Endo for these costs and expenses through adjustments to the pricing of TIMERx material that the Company supplies to Endo for use in Opana ER. In connection with the amendment, in July 2008, Endo reimbursed the Company for such costs and expenses incurred prior to June 30, 2008, totaling approximately $470,000. The Company credited such reimbursement to selling, general and administrative expense. Such costs incurred by the Company subsequent to June 30, 2008 were not significant and have been reimbursed to the Company by Endo.
     In March 2009, the Company and Endo entered into a Third Amendment to the Amended and Restated Strategic Alliance Agreement with respect to Opana ER, effective January 1, 2009.2009 (the “Third Amendment”). Under the terms of this amendment, Endo agreed to directly reimburse the Company for costs and expenses incurred by the Company in connection with patent applications and patent maintenance related to Opana ER. If any of such costs and expenses are not reimbursed to the Company by Endo, the Company may bill Endo for these costs and expenses through adjustments to the pricing of TIMERx material that the Company supplies to Endo for use in Opana ER. In connection with the amendment, Endo reimbursed the Company for such costs and expenses incurred prior to December 31, 2008, which had been capitalized as patent assets, in the amount of $206,000. Such payment, as well as reimbursement by Endo of an additional $23,000 in patent costs incurred prior to the Third Amendment, was received by the Company in Aprilthe second quarter of 2009. The Company credited such reimbursementreimbursements to its patent assets in the threesix month period ended March 31,June 30, 2009. Such patent related costs and expenses incurred by the Company subsequent to December 31, 2008 were not significant andthe Third Amendment have either been reimbursed or are expected to be reimbursed to the Company by Endo.Endo, with such reimbursements recorded by the Company as offsets to its costs.
     On May 7, 2009, the Company received notice from Draxis Specialty Pharmaceuticals Inc. (“Draxis”), its contract manufacturer of TIMERx material, that as a result of its decision to cease manufacturing of solid dosage form products in the facility in which TIMERx is currently manufactured, it will not renew its manufacturing agreement with

14


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
the Company upon the expiration of the current term in November 2009. As a result, the Company intends to increase its current inventory levels of TIMERx material and will work with Endo on various alternatives, including the qualification of another manufacturer.
     On June 8, 2009, Endo and Valeant Pharmaceuticals (“Valeant”) signed an exclusive license granting Valeant the right to develop and commercialize Opana ER in Canada, Australia and New Zealand (the “Valeant Agreement”). Under the terms of the Valeant Agreement, Valeant paid Endo an upfront fee of C$2 million, and agreed to make payments totaling up to C$1 million when certain sales milestones are achieved in Canada, and AUS $1.1 million when certain regulatory and sales milestones are achieved in Australia. In addition, Valeant has agreed to pay tiered royalties ranging from 10% to 20% of annual net sales of Opana ER in each of the three countries, subject to royalty reductions upon patent expiry or generic entry. The Valeant Agreement also includes rights to Opana®, the immediate release formulation of oxymorphone developed by Endo. In connection with the Valeant Agreement, the Company signed a supply agreement with Valeant, agreeing to supply bulk TIMERx material to Valeant for its use in manufacturing Opana ER under the Valeant Agreement, the selling price of which will approximate Penwest’s cost, as defined in the agreement, and may be adjusted annually.
     In connection with the Valeant Agreement and the Company’s supply agreement with Valeant, on June 8, 2009, the Company and Endo signed a consent agreement, consenting to these arrangements and confirming the share of

14


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
the payments to be made by Valeant that would be due to the Company. As of June 30, 2009, the Company recorded a receivable from Endo in the amount of $764,000 for its share of the upfront payment received by Endo, which amount the Company recorded as deferred revenue. In accordance with the payment terms, the Company received this payment from Endo in July 2009. The Company and Endo will share equally in the royalties and sales milestones received from Valeant for Opana ER under the terms of the Valeant Agreement.
Edison Pharmaceuticals, Inc.
     On July 16, 2007, the Company entered into the Edison Agreement under which the Company and Edison agreed to collaborate on the development of Edison’s lead drug candidate, A0001, and up to one additional candidate of Edison’s. Under the terms of the Edison Agreement, the Company has exclusive worldwide rights to develop and commercialize A0001 and the additional compound of Edison’s, which the Company may exercise its option to select, for all indications, subject to the terms and conditions in the Edison Agreement. The Company is currently developing A0001, a drug candidate that it is initially targetingtargeted for the treatment of inherited mitochondrial respiratory chain diseases. A0001 has been granted orphan drug designation by the FDA for treatment of inherited mitochondrial respiratory chain diseases.
     InAs consideration for the rights granted to the Company under the Edison Agreement, the Company paid Edison an upfront cash payment of $1.0 million upon entering into the Edison Agreement and agreed to loan Edison up to an aggregate principal amount of $1.0 million solely to fund Edison’s research and development, with the right to draw upon such loan commitment in one or more installments at any time prior to the earliest of July 16, 2012, the occurrence of an event of default, a change in control of Edison or the termination of the Edison Agreement, solely to fund Edison’s research and development.Agreement. The Company is also required to make payments to Edison upon achievement of specified milestones set forth in the Edison Agreement, and royalty payments based on net sales of products containing A0001 and any other compound as to which the Company has exercised its option.
     On February 5, 2008, the Company loaned Edison $1.0 million pursuant to the loan agreement provisions of the Edison Agreement. The loan bears interest at an annual rate of 8.14%, which rate is fixed for the term of the loan. The loan matures as of the earlier of July 16, 2012 and the occurrence of an event of default, as defined in the Edison Agreement. All accrued and unpaid interest is payable on the maturity date; however, interest accruing on any outstanding loan amount after July 16, 2010 is due and payable monthly in arrears. During the first quarter of 2008, the Company recorded an impairment charge of $1.0 million to selling, general and administrative expense as a result of its collectability assessment of the loan to Edison. In addition, as a result of the Company’s continuing collectability assessment, the Company is not recognizing any accrued interest income on the loan to Edison. The amount of such accrued interest income not recognized by the Company approximated $22,000 and $44,000, respectively, for the three and six month periodperiods ended March 31,June 30, 2009 and $12,000$21,000 and $33,000, respectively, for the three and six month periodperiods ended March 31,June 30, 2008. Cumulatively, as of June 30, 2009, such accrued interest not recognized by the Company approximated $120,000.
     TheUnder the Edison Agreement, the Company also agreed to pay Edison a total of $5.5 million over the initial 18 months of the research period to fund Edison’s discovery and research activities during the period. The funding iswas made in the form of payments made in advance each quarter. As of March 31,June 30, 2009, the Company had paid approximately $5.4 million of such amount. Foramount, and no further research and development funding is owed to Edison in accordance with the three month periods ended March 31,May 5, 2009 and 2008, the Company recorded approximately $998,000 and $2.2 million, respectively, in researchagreement with Edison, described below. Research and development expense associated with the Edison collaboration, which included expenses relating to the development of A0001 and contract research payments to Edison.Edison were approximately $1.5 million for each of the three month periods ended June 30, 2009 and 2008, and $2.5 million and $3.6 million for the six month periods ended June 30, 2009 and 2008, respectively. The Company had the option to extend the term of the research period for up to three consecutive six monthsix-month periods, subject to the Company’s funding of Edison’s activities in amounts to be agreed upon. The Companyupon, but did not exercise this option upon the expiration of the initial 18 month research period.option. During the initial 18 months of the research period, in which the Company’s funding exceeds a specified amount, Edison agreed not to develop or commercialize any compounds, by itself, or with or on behalf of any third party, for the treatment of certain inherited mitochondrial diseases, other than under the collaboration with the Company, or under specified circumstances. Until 60 days after the later of the presentation of a development candidate by Edison, or the expiration of the research period, and in other specified circumstances, Edison has agreed not to disclose or provide to another party, or enter into any agreement with another party granting any options or rights to, any compound believed to have activity in the treatment of certain inherited mitochondrial diseases. Edison has not yet presented the Company with the additional compound and has the option to continue their work at their own expense. Until Edison presents the Company with the additional compound, they are not able to present compounds to any parties, or develop or commercialize any compounds by itself or on behalf of a third party. If they are unable to present the additional compound, then the Edison Agreement calls for credits which will be applied against payments on A0001.

15


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     FollowingIn the third quarter of 2009, Edison presented the Company with the additional compound. The Company expects to make a decision on its selection of this compound by the end of the research period,third quarter. If the Company selects this additional compound, it would be obligated to make a milestone payment to Edison in the amount of $250,000, after the 50% reduction provided for under the May 5, 2009 agreement, described below.
     The license for any compound under the Edison Agreement ends, on a country-by-country, product-by-product basis, when neither Edison nor the Company has any remaining royalty payment obligations to eachthe other with respect to such compound. Each party’s royalty payment obligation ends upon the later of expiration of the last-to-expire claim of all licensed patents covering such party’s product or expiration of the FDA’s designation of such product as an orphan drug. The Edison Agreement may be terminated by the Company with 120 days prior written notice to Edison. The Edison Agreement may also be terminated by either party in the event of the other party’s uncured material breach or bankruptcy.
     On May 4,5, 2009, the Company and Edison signedentered into an amendment to the Edison Agreementagreement under which Edison agreed that the Company can applycould offset $550,000, and following that, the loan amount of $1.0 million plus accrued interest, and an additional $550,000 against 50% of any future milestone and royalty payments which may be due to Edison under the terms of the Edison Agreement. The loan amount is otherwise due and payable by Edison according to the original loan terms under the loan agreement. In addition, the amendmentagreement provides that the Company has no further contractual payment obligations in connection with the research period.
Mylan Pharmaceuticals Inc.
     On March 2, 2000, Mylan announced that it had signed a supply and distribution agreement with Pfizer to market generic versions of all three strengths (30 mg, 60 mg, 90 mg) of Pfizer’s generic Procardia XL. In connection with that agreement, Mylan decided not to market Nifedipine XL, a generic version of Procardia XL that the Company had developed in collaboration with Mylan. As a result, Mylan entered into a letter agreement with the Company whereby Mylan agreed to pay Penwest a royalty on all future net sales of Pfizer’s generic version of Procardia XL 30 mg. The royalty percentage was comparable to the percentage called for in Penwest’s original agreement with Mylan for Nifedipine XL 30 mg. Mylan has retained the marketing rights to Nifedipine XL 30 mg. Mylan’s sales in the United States in 2008 of Pfizer’s generic version of Procardia XL 30 mg totaled approximately $14.9 million. The term of the letter agreement continues until such time as Mylan permanently ceases to market Pfizer’s generic version of Procardia XL 30 mg. In 2008, 2007 and 2006, royalties from Mylan were approximately $1.8 million, $2.6 million and $3.1 million, respectively, or 21%, 77% and 89%, respectively, of the Company’s total revenue.revenue in such years.
     Royalties from Mylan were approximately $350,000$426,000 and $422,000$537,000 for the three month periods ended March 31,June 30, 2009 and 2008, respectively, and $776,000 and $959,000 for the six month periods ended June 30, 2009 and 2008, respectively.
Drug Delivery Technology Collaborations
     The Company enters into development and licensing agreements with third parties under which the Company develops formulations of generic or third parties’ compounds, utilizing the Company’s TIMERx drug delivery technologies and formulation expertise. In connection with these agreements, the Company generally receives nonrefundable up-frontupfront payments which are recorded as deferred revenue upon receipt and are recognized as revenue over the respective contractual performance periods. Under these agreements, the Company may also be reimbursed for development costs incurred up to amounts specified in each agreement. Additionally, under these agreements, the Company may receive milestone payments upon the achievement of specified events. Finally, these agreements may provide for the Company to receive payments from the sale of bulk TIMERx material and royalties on product sales upon commercialization of the product. As of March 31,August 10, 2009, the Company is a party to threefour such drug delivery technology collaborations.

16


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
14. Contingencies
     Substantial patent litigation exists in the pharmaceutical industry. Patent litigation generally involves complex legal and factual questions, and the outcome frequently is difficult to predict. An unfavorable outcome in any patent litigation involving the Company could cause the Company to paybe liable for substantial damages, alter its products or processes, obtain additional licenses and/or cease certain activities. Even if the outcome is favorable to the Company, the Company could incur substantial litigation costs.

16


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
costs in litigating such matters.
Impax ANDA Litigation
     On October 3, 2007, the Company received a letter from IMPAX notifying the Company of the filing by IMPAX of an Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV certification under 21 U.S.C. § 355(j) for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. This Paragraph IV certification notice referred to the Company’s patent, U.S. Patent No. 7,276,250, which covers the formulation of Opana ER and was listed in the Orange Book as of October 2, 2007. On October 4, 2007, IMPAX announced in a press release that the FDA had rescinded the acceptance of IMPAX’s ANDA filing. On November 5, 2007, the Company received a letter from IMPAX notifying it of additional Paragraph IV certifications relating to the Company’s patents, U.S. Patent Nos. 5,622,933 and 5,958,456, which were listed in the Orange Book as of October 19, 2007. On November 15, 2007, Endo and the Company filed a lawsuit against IMPAX in the U.S. District Court of Delaware, or (“U.S. Dist. Delaware.Delaware”). The lawsuit against IMPAX not only alleged infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 but also sought declaratory judgment that, among other things, IMPAX had no legitimate basis to trigger the Hatch-Waxman ANDA patent litigation process because the FDA, according to IMPAX, had rescinded its acceptance of IMPAX’s ANDA. It further asked the court to declare that the Paragraph IV certification notices that IMPAX served on Endo and the Company are null, void and of no legal effect. On December 14, 2007, the Company received a letter from IMPAX notifying it of a refiling of its ANDA for Opana ER that was accepted by the FDA as of November 23, 2007. The notice letter states that IMPAX’s ANDA contains Paragraph IV certifications for the three patents noted above and that the FDA had required IMPAX to notify Endo and the Company of these certifications. In this notice, IMPAX also stated that it would not withdraw its prior Paragraph IV certification notices because it believed they were properly provided and because IMPAX was continuing to seek to convince the FDA to assign an earlier filing date to its ANDA. As a result of the FDA’s determination of IMPAX’s ANDA filing date and the receipt of the new Paragraph IV certification notice, on December 20, 2007, the Company and Endo filed a notice of dismissal of the portion of its November 15, 2007 complaint seeking declaratory judgment that, among other things, IMPAX had no basis to trigger the Hatch-Waxman ANDA patent litigation process and that any Paragraph IV certification notices served prior to November 23, 2007 were null, void and of no legal effect. The Company and Endo did not dismiss the patent infringement claims because IMPAX refused to withdraw its prior Paragraph IV certification notices. On January 25, 2008, Endo and the Company filed a lawsuit against IMPAX in U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 in response to IMPAX’s December notice. Given the FDA’s acceptance of IMPAX’s ANDA as of November 23, 2007, we believethe Company believes that we areit is entitled to a 30-month stay under the Hatch-Waxman Act beginning on December 14, 2007.
     On or around June 14, 2008, the Company and Endo each received a notice from IMPAX advising the Company and Endo that IMPAX had amended its ANDA for Opana ER to include three additional strengths, 7.5 mg, 15 mg and 30 mg. This ANDA amendment contained a Paragraph IV certification against the Company’s Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On July 25, 2008, the Company and Endo filed a lawsuit against IMPAX in U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 in response to the notice. The Company and Endo believebelieves that we areit is entitled to a 30-month stay under the Hatch-Waxman Act beginning on June 14, 2008 with respect to IMPAX’s amended ANDA for 7.5 mg, 15 mg and 30mg.
     In January 2009, the cases against IMPAX were reassigned to the U.S. District Court of New Jersey (“U.S. Dist. NJ”).

17


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
Actavis ANDA Litigation
     On or around February 14, 2008, the Company received a notice from Actavis advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. The Actavis Paragraph IV certification notice refers to the Company’s Orange Book listed patents, U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456 and 7,276,250, which cover the formulation of Opana ER. U.S. Patent No. 5,128,143 expired in 2008 and the other patents expire in 2013, 2013 and 2023, respectively. On March 28, 2008, Endo and the Company filed a lawsuit against Actavis in the U.S. District Court of New Jersey, or U.S. Dist. NJ, alleging infringement of U.S. Patent No. 5,958,456. On June 2, 2008, the Company and Endo each received a notice from Actavis advising the Company and Endo that Actavis had amended its ANDA for Opana ER to include two additional strengths, 7.5 mg and 15 mg. On July 2, 2008, the Company and Endo each

17


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
received a third notice from Actavis advising that Actavis had further amended its ANDA to include the 30mg strength. Each ANDA amendment contained a Paragraph IV certification against the Company’s Orange Book listed patents, U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456 and 7,276,250. On July 11, 2008, the Company and Endo filed a lawsuit against Actavis in the U.S. Dist. NJ alleging infringement of U.S. Patent No. 5,958,456 based on these two additional Paragraph IV certification notices from Actavis. The Company and Endo believe they are entitled to a 30-month stay with respect to Actavis’ ANDA covering Opana ER 5 mg, 10 mg, 20 mg and 40 mg beginning February 14, 2008, with respect to Actavis’ amended ANDA covering Opana ER 7.5 mg and 15 mg beginning June 2, 2008 and against its amended ANDA covering Opana ER 30 mg beginning July 2, 2008.
     On February 20, 2009, the Company and Endo settled all of the Actavis litigation. Both sides agreed to dismiss their respective claims and counterclaims with prejudice. Under the terms of the settlement, Actavis agreed not to challenge the validity or enforceability of the Company’s four Orange Book-listed patents. The Company and Endo agreed to grant Actavis a license under US Patent No. 5,958,456 and a covenant not to sue for its generic formulation of Opana ER under the Company’s four Orange Book-listed patents. The license and covenant not to sue will take effect on July 15, 2011, and earlier under certain circumstances.
     The settlement is subject to the review of the U.S. Federal Trade Commission and Department of Justice.
Sandoz ANDA Litigation
     On or around July 10,14, 2008, the Company and Endo each received a notice from Sandoz advising the Company and Endo that Sandoz had filed with the FDA an ANDA for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. This ANDA contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On August 22, 2008, the Company and Endo filed a lawsuit against Sandoz in the U.S. Dist. Delaware, alleging infringement of U.S. Patent No. 5,958,456 in response to this notice.
     On or around November 17,20, 2008, the Company received a notice from Sandoz that it had filed an amendment to its ANDA containing Paragraph IV certifications for the 7.5 mg, 15 mg and 30 mg dosage strengths of oxymorphone hydrochloride extended release tablets. The notice covers Penwest’s U.S. Patent Nos. 5,128,143, 7,276,250, 5,958,456 and 5,662,933. On December 30, 2008, the Company and Endo, filed suit against Sandoz in the United States District Court for the District of New Jersey.U.S. Dist. NJ. The lawsuit alleges infringement of an Orange Book-listed U.S. patent that covers the Opana® ER formulation. In response, Sandoz filed an answer and counterclaims, asserting claims for declaratory judgment that the patents listed in the Orange Book are invalid, not infringed and/or unenforceable. The Company cannot predict the outcome of this litigation. The Company and Endo intend to pursue all available legal and regulatory avenues in defense of Opana® ER, including enforcement of the Company’s intellectual property rights and approved labeling.
     In January 2009, the case against Sandoz was reassigned to the U.S. Dist. NJ.
Barr ANDA Litigation
     On or around September 12, 2008, the Company and Endo each received a notice from Barr advising the Company and Endo that Barr had filed with the FDA an ANDA for Opana ER in 40 mg strength. On or around

18


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
September 13, 2008, the Company and Endo received an additional notice that Barr’s ANDA was amended to include the strengths of 5 mg, 10 mg and 20 mg. Barr’s ANDA, as amended, contained a Paragraph IV certification against the Company’s Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On October 20, 2008, the Company and Endo filed a lawsuit against Barr in the U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456.
In January 2009, the case against Barr was reassigned to the U.S. Dist. NJ.

18


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
     On or around June 2, 2009, the Company and Endo received an additional notice that Barr’s ANDA was amended to include the strengths of 7.5 mg, 15 mg and 30 mg. Barr’s ANDA, as amended, contained a Paragraph IV certification against the Company’s Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On July 2, 2009, the Company and Endo filed a lawsuit against Barr in the U.S. Dist. NJ, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456.
Tang/Edelman Shareholder Claim
     In March and April 2009, Tang Capital Partners, LP (“Tang Capital”) and Perceptive Life Sciences Master Fund Ltd. (“Tang Capital and Perceptive”), the Company’s two largest shareholders, have provided notice that they intend to nominatebrought three lawsuits against the Company. Following the dismissal of the two Thurston County actions and solicit proxies for their own nominees for electionthe amendment of the complaint in King County, as directors at this year’s annual meeting of shareholders scheduled for June 10, 2009 and to make a number of shareholder proposals for consideration at the meeting.
     Indiscussed below, one lawsuit remains pending. The lawsuits were brought in connection with theira proxy battle,contest initiated by Tang Capital and Perceptive have brought three suits against the Company seeking injunctive relief, two of which are still pending.Perceptive.
     On March 12, 2009, Tang Capital and Perceptive brought suit against the Company in the Superior Court of the State of Washington, Thurston County, (Tang Capital Partners, et al. v.Penwest Pharmaceuticals Co., No. 09-2-00617-0), seeking declaratory and injunctive relief to uphold their claims that their notice of nomination noticeof directors had satisfied the requirements set forth in the Company’s bylaws and requesting that the court issue an order preventing the Company from seeking to disallow or otherwise prevent or not recognize their nominations, or the casting of votes in favor of their designees, on the basis that they had not complied with the provisions of ourthe Company’s bylaws or applicable state law. On March 13, 2009, Tang Capital and Perceptive moved for a preliminary injunction to enjoin the Company from mailing any ballots to shareholders that containcontained provisions to vote for director nominees and enjoining any shareholder vote on individuals nominated for the board of directors unless the three designees of Tang Capital and Perceptive arewere permitted to be nominated and votes arewere permitted to be cast in their favor, or a court resolvesresolved the merits of their declaratory judgment action described above. On March 20, 2009, the Company confirmed in writing that Tang Capital and Perceptive’s nomination notice had been timely received and that, assuming the accuracy and completeness of the information contained in their notice, their notice in all other respects met the requirements of the Company’s bylaws in regard to notices of intention to nominate. On March 23, 2009, Tang Capital and Perceptive withdrew their motion for injunctive relief, and on April 10, 2009, they voluntarily dismissed the suit.
     On April 21,20, 2009, Tang Capital and Perceptive brought suit against the Company in the Superior Court of the State of Washington, King County, (Tang Capital Partners, et al. v.Penwest Pharmaceuticals Co.), No. 09-2-16472-0), seeking to enforce their alleged rights under the Washington Business Corporation Act to inspect certain Company documents. The Company’s position is that certain of the requested documents are outside the scope of documents for which the Washington Business Corporation Act permits a statutory inspection right and that certain of the conditions to qualify for statutory inspection rights have not been satisfied. A schedule for resolution of this claim has not yet been set.
     On April 28, 2009, Tang Capital and Perceptive brought suit against the Company in the Superior Court of the State of Washington, Thurston County, (Tang Capital Partners, et al. v. Penwest Pharmaceuticals Co.), seeking either for the court to set the number of directors to be elected at the 2009 annual meeting of shareholders at three rather than two, or for the court to require the Company to waive the advance notice provisions of its bylaws to permit themTang Capital and Perceptive to include a proposal in which the required percentage for board approval of certain matters would be 81% or more, rather than 75% or more. On May 13, 2009, Plaintiffs intend to seekdismissed this Thurston County action, reasserting the same claims via an amended complaint in the King County action. Plaintiffs sought preliminary injunctive relief on their claims before the 2009 annual meeting of shareholders and the motion was denied by the court. Tang Capital and Perceptive then filed a subsequent claim for a trial. Although these

19


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
claims are still outstanding in King County, the proposed bylaw amendment was not approved by the Company’s shareholders at the 2009 annual meeting. The trial on these claims is currently scheduled for June 10, 2009.October 4, 2010.
     The Company is also a party from time to time to certain other types of claims and proceedings in the ordinary course of business. The Company does not believe any of these matters will result, individually or in the aggregate, in a material adverse effect upon its financial condition or future results of operations.
15. Subsequent Events
     The Company has evaluated all subsequent events through August 10, 2009, which represents the filing date of this Form 10-Q with the Securities and Exchange Commission, to ensure that this Form 10-Q includes appropriate disclosure of events both recognized in the financial statements as of June 30, 2009, and events which occurred subsequent to June 30, 2009 but were not recognized in the financial statements.

1920


PENWEST PHARMACEUTICALS CO.
NOTES TO CONDENSED FINANCIAL STATEMENTS (continued)
(Unaudited)
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
     Overview
     We are a drug development company focused on identifying and developing products that address unmet medical needs, primarily for rare disorders of the nervous system. We are currently developing A0001, or alpha tocopherol quinone, a coenzyme Q analog drug candidate that we licensed from Edison Pharmaceuticals, Inc., or Edison, for inherited mitochondrial respiratory chain diseases. We are also applying our drug delivery technologies and drug formulation expertise to the formulation of product candidates under licensing collaborations, which we refer to as drug delivery technology collaborations.
     Opana® ER is an extended release formulation of oxymorphone hydrochloride that we developed with Endo Pharmaceuticals Inc., or Endo, using our proprietary TIMERx® drug delivery technology. Opana ER was approved by the United States Food and Drug Administration, or FDA, in June 2006 for twice-a-day dosing in patients with moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time, and is being marketed by Endo in the United States. In 2008, we began to recognize royalties from Endo related to sales of Opana ER. In the threesix month period ended March 31,June 30, 2009, we recognized $4.4$8.8 million in royalties from Endo related to sales of Opana ER. We are currently seeking to license Opana ER for development and commercialization in territories outside the United States. In June 2009, Endo signed an agreement with Valeant Pharmaceuticals, or Valeant, to market Opana ER in Canada, Australia and New Zealand. We and Endo continue to work toward achieving additional licensing deals for Opana ER in other territories outside the United States. Under our agreement with Endo, we and Endo share the rights to Opana ER outside the United States, and we would share equally any economics related to Opana ER from a related collaboration with a third party.
     We are currently developing A0001 a drug candidate that we are initially targeting for the treatment of inherited mitochondrial respiratory chain diseases, under a collaboration and license agreement with Edison that we entered into in July 2007. We are currently conducting a Phase Ib multiple ascending dose safety study of A0001 in healthy subjects. If A0001 demonstrates an acceptable safety profile and tolerability in this Phase Ib study, we plan to commence a Phase IIa trial in patients with inherited mitochondrial respiratory chain diseases in2007 (as amended, the second half of 2009. The goal of this trial will be to determine if A0001 has biological activity.“Edison Agreement”). Under the Edison agreement,Agreement, we have agreed to collaborate with Edison on the development of A0001 and up to one additional drug candidate of Edison’s. In June 2009, we completed a Phase Ib multiple ascending dose safety study in healthy subjects. In the Phase Ib trial, the drug was well tolerated by subjects and no serious adverse events were reported. In addition, we observed a dose-dependent increase in exposure approaching steady state within two to four days following repeat dosing, and were able to establish a maximum tolerated dose. Based on these results, we plan to advance A0001 into Phase IIa studies in patients with mitochondrial diseases in the fourth quarter of 2009. We intend to commence two Phase IIa trials — one trial focused on patients with Friedreich’s Ataxia and another trial focused on patients with the A3243G mitochondrial DNA point mutation associated with MELAS syndrome. The goal of these trials will be to determine if A0001 has biological activity. We expect data from both of these trials in the first half of 2010.
     We are a party to a number of collaborations involving the use of our extended release drug delivery technologies as well as our formulation development expertise. Under these collaborations, we are responsible for completing the formulation work on a product specified by our collaborator. If we are successful, we transfer the formulation to our collaborator, who is then responsible for the completion of the clinical development, and ultimately, the commercialization of the product. Under the terms of these agreements, we generally receive up-frontupfront fees, reimbursement of research and product development, or R&D, costs incurred, up to amounts specified in each agreement, and potential milestone payments upon the achievement of specified events. These agreements also provide for us to receive payments from the sale of bulk TIMERx material and royalties on product sales upon commercialization of the product. As of March 31,June 30, 2009, we are a party to threefour such drug delivery technology collaborations. We are seeking to enter into additional drug delivery technology collaborations.
     Our strategy is to identify and develop products that address unmet medical needs, primarily for rare disorders of the nervous system. In support of this strategy, we have set four clearly defined goals for 2009:
Maximizing the value of Opana ER, working closely with Endo.We are working with Endo to take steps to protect and prosecute the intellectual property around Opana ER and to explore licensing opportunities for Opana ER outside the United States. The agreement with Valeant is a result of these efforts.

21


Maximizing the value of Opana ER, working closely with Endo.We plan to continue to take steps to protect and prosecute the intellectual property around Opana ER and explore licensing opportunities for Opana ER outside the United States.
  Advancing the development of A0001 drug candidate.Through the plannedcompleted Phase Ib and the planned Phase IIa trials, we are seeking to establish proof of concept with respect to both safety and efficacy.
 
  Monetizing the value of our proven drug delivery technologies and drug formulation expertise by executing additional deals.We are seekingOur goal is to enter into at least two new collaborations in 2009. We believe that with two agreements this aspect of our business can operate on a breakeven basis, fund a portion of our overhead and provide us with a financial stake in products, should theythe collaborations advance ininto development and commercialization. In June 2009, we entered into a new collaboration with Otsuka Pharmaceuticals Co., Ltd.
Managing overhead and other costs to ensure that our infrastructure is sized appropriately to our priorities.In the six months ended June 30, 2009, we continued to reduce expenses and closely managed our cash expenditures, including staff reductions implemented in January 2009.

20


Managing overhead and other costs to ensure that our infrastructure is sized appropriately to our priorities.In the three month period ended March 31, 2009, we continued to reduce expenses and closely managed our cash expenditures, including staff reductions implemented in January 2009.
     In January 2009, we implemented staff reductions of approximately 18% of our workforce as part of our efforts to aggressively manage our overhead cost structure. The terms of the severance arrangements we entered into with terminated employees include severance pay and continuation of certain benefits, including medical insurance, over the respective severance periods. In connection with these severance arrangements, we recorded a severance charge in our statement of operations for the first quarter of 2009 of $550,000, of which $355,000$117,000 was unpaid as of March 31,June 30, 2009 but will be paid over the remainder of 2009. Of such severance charge, $464,000 and $86,000 were recorded as selling, general and administrative, or SG&A, expense, and research and developmentR&D expense, respectively. In addition, as a result of these terminations, in the first quarter of 2009, we recorded a non-cash credit of $885,000 under SFAS No. 123R associated with the forfeiture of stock options held by these former employees. Of such amount, $844,000 and $41,000 were recorded as credits to selling, general and administrative expense, and research and developmentR&D expense, respectively.
Products
     Opana ER.Opana ER is an oral extended release opioid analgesic, which we developed with Endo, using our proprietary TIMERx® technology. In June 2006, the FDA approved for marketing Opana ER, for twice-a-day dosing in patients with moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. Under the terms of our collaboration with Endo, Endo launched Opana ER in the United States in July 2006 in 5 mg, 10 mg, 20 mg and 40 mg tablets, and in March 2008 in 7.5 mg, 15 mg and 30 mg tablets.
     Under the terms of our collaboration with Endo, Endo pays us royalties based on U.S. net sales of Opana ER. No payments were due to us for the first $41 million of royalties otherwise payable to us beginning from the time of the product launch in July 2006, a period we refer to as the royalty holiday. In the third quarter of 2008, the royalty holiday ended and we began earning royalties from Endo on sales of Opana ER. Endo has the right under our agreement to recoup the $28 million in development costs that Endo funded on our behalf prior to the approval of Opana ER, through a temporary 50% reduction in royalties. For the three and six month periodperiods ended March 31,June 30, 2009, we recognized $4.4 million and $8.8 million, respectively, in royalties from Endo on sales of Opana ER. ThisThese royalty amount reflectsamounts reflect this temporary reduction. As of March 31,June 30, 2009, $9.4$13.8 million of the $28 million has been recouped by Endo.
     In March 2009, we and Endo entered into a Third Amendment to the Amended and Restated Strategic Alliance Agreement with respect to Opana ER, effective January 1, 2009. Under the terms of this amendment, Endo agreed to directly reimburse us for costs and expenses incurred by us in connection with patent applications and patent maintenance costs related to Opana ER. If any of such costs and expenses are not reimbursed to us by Endo, we may bill Endo for these costs and expenses through adjustments to the pricing of TIMERx material that we supply to Endo for use in Opana ER. In connection with the amendment, Endo reimbursed us for such costs and expenses incurred prior to December 31, 2008, which we had been capitalized as patent assets, in the amount of $206,000. SuchWe received such payment, was receivedas well as reimbursement by Endo of an additional $23,000 in Aprilpatent costs incurred prior to the Third Amendment, in the second quarter of 2009. We credited such reimbursementreimbursements to our patent assets. Suchassets in the six month period ended June 30, 2009. Patent-related costs and expenses that we incurred by us subsequent to December 31, 2008 were not significant andthe Third Amendment have either been reimbursed or are expected to be reimbursed to us by Endo, with these reimbursements recorded by us as offsets to our costs.

22


     On June 8, 2009, Endo and Valeant signed an exclusive license granting Valeant the right to develop and commercialize Opana ER in Canada, Australia and New Zealand (the “Valeant Agreement”). Under the terms of the Valeant Agreement, Valeant paid Endo an upfront fee of C$2 million, and agreed to make payments totaling up to C$1.0 million when certain sales milestones are achieved in Canada, and AUS$1.1 million when certain regulatory and sales milestones are achieved in Australia. In addition, Valeant has agreed to pay tiered royalties ranging from 10% to 20% of annual net sales of Opana ER in each of the three countries, subject to royalty reductions upon patent expiry or generic entry. The Valeant Agreement also includes rights to Opana®, the immediate release formulation of oxymorphone developed by Endo. In July 2008,connection with the Valeant Agreement, we signed a supply agreement with Valeant, agreeing to supply bulk TIMERx material to Valeant for its use in manufacturing Opana ER under the Second AmendmentValeant Agreement. The selling price to Valeant will approximate Penwest’s costs, as defined in the agreement, and may be adjusted annually.
     In connection with the Valeant Agreement and the supply agreement, on June 8, 2009, we and Endo signed a similarconsent agreement relatedconsenting to patent enforcement litigation costs.these arrangements and confirming the share of the payments to be made by Valeant that would be due to us. As of June 30, 2009, we recorded a receivable from Endo in the amount of $764,000 for our share of the upfront payment received by Endo, which amount we recorded as deferred revenue. In accordance with the payment terms, we received this payment from Endo in July 2009. We and Endo will share equally in the royalties and sales milestones received from Valeant for Opana ER under the terms of the Valeant Agreement.
     Opana ER is not approved for marketing outside the United States. We are currently seeking collaboratorsand Endo continue to seek collaborations to develop and commercialize Opana ER in various territories outside the United States. Under the terms of our agreement with Endo, any fees, royalties, payments or other revenues received by the parties in connection with any collaborator outside the United States will be divided equally between Endo and us. A description of our agreement with Endo is included under the caption “Collaborative and Licensing Agreements” in “Part I. Item 1- Notes to Condensed Financial Statements”.Statements.”

21


     IMPAX Laboratories, Inc., or IMPAX, Actavis South Atlantic LLC, or Actavis, and Sandoz, Inc., or Sandoz, and Barr Laboratories, Inc., or Barr, have each filed abbreviated new drug applications, or ANDA’s, that, together with their respective amendments, cover all seven strengths of Opana ER. Barr Laboratories, Inc., or Barr, has also filed an ANDA that covers the Opana ER 5 mg, 10 mg, 20 mg and 40 mg strengths. These ANDA filings each contained paragraph IV certifications under 21 U.S.C. Section 355(j). We and Endo have filed patent infringement lawsuits against each of IMPAX, , Actavis, Sandoz and Barr in connection with their respective ANDA’s.
     We intend to pursue all available legal and regulatory avenues to defend Opana ER. We believe that we are entitled to a 30-month stay under the Hatch Waxman Act against IMPAX’s ANDA, Actavis’ ANDA, Sandoz’s ANDA and Barr’s ANDA. IMPAX has announced that it is seeking to reinstate an earlier filing date of its ANDA covering Opana ER 5mg, 10 mg, 20 mg and 40 mg. If this occurs, or if we and Endo are unsuccessful in these legal proceedings, Opana ER could be subject to generic competition earlier than the end of the 30-month stay.
     On February 20, 2009, we and Endo settled all of the Actavis litigation. Both sides agreed to dismiss their respective claims and counterclaims with prejudice. Under the terms of the settlement, Actavis agreed not to challenge the validity or enforceability of our four Orange Book-listed patents. We and Endo agreed to grant Actavis a license under US Patent No. 5,958,456 and a covenant not to sue for itsActavis’s generic formulation of Opana ER under our four Orange Book-listed patents. The license and covenant not to sue will take effect on July 15, 2011, andor earlier under certain circumstances.
     The settlement is subject to the review of the U.S. Federal Trade Commission and Department of Justice.
     A description of the legal proceedings related to Opana ER and the settlement with Actavis are included in “Part II. Item 1 — Legal Proceedings.”
     A0001.A0001, or alpha tocopherol quinone, is a coenzyme Q analog that we are developing under our collaboration and licensing agreement with Edison. Coenzyme Q is a molecule intrinsic to mitochondria and its production of energy in the body. We are developing A0001 for the treatment of inherited mitochondrial respiratory chain diseases. We believe that impairment of mitochondrial function is a significant factor in a number of inherited mitochondrial respiratory chain diseases. As such, we believe that enhancing mitochondrial function may provide

23


substantial clinical benefit to patients suffering from mitochondrial respiratory chain disease. A0001 has shown strong biological activity in cell assays developed by Edison to test the ability of the class to rescue cells from death caused by inherited mitochondrial diseases.
     In May 2008, we submitted an Investigational New Drug application, or IND, for A0001 for the treatment of symptoms associated with inherited mitochondrial respiratory chain diseases. In July 2008, we initiated a Phase Ia placebo-controlled, single ascending dose trial designed to evaluate the safety and tolerability of A0001 in healthy subjects, and to collect pharmacokinetic data. A0001 was well tolerated by all subjects across all dose groups and there were no drug-related serious adverse events. In FebruaryJune 2009, we initiatedcompleted a Phase Ib multiple ascending dose clinicalsafety study of A0001 in healthy subjects. The study isIn the Phase Ib trial, the drug was well tolerated by subjects and no serious adverse events were reported. In addition, we observed a single-blind, placebo-controlled, multiple ascending dose clinical trialdose-dependent increase in healthy subjects, designedexposure approaching steady state within two to assess the safety, tolerability, and pharmacokinetics of A0001four days following repeat dosing, in healthy male and female subjects. Wewere able to establish a maximum tolerated dose. Based on these results, we plan to enroll a total of approximately 30 healthy subjectsadvance A0001 into Phase IIa studies in patients with mitochondrial diseases in the trial. We expect that results from this study will be available in the secondfourth quarter of 2009. If A0001 demonstrates an acceptable safety profile and tolerability in this Phase Ib study, we planWe intend to commence atwo Phase IIa trials — one trial infocused on patients with inheritedFriedreich’s Ataxia and another trial focused on patients with the A3243G mitochondrial respiratory chain diseasesDNA point mutation associated with MELAS syndrome. The goal of these trials will be to determine if A0001 has biological activity. We expect data from both of these trials in the secondfirst half of 2009. We are currently working on the study design for the Phase IIa program.2010. In parallel with the Phase Ib trial, we have initiated long-term animal toxicology studies to support the clinical program.
     Under the terms of the Edison agreement,Agreement, we have exclusive, worldwide rights to develop and commercialize A0001 and up to one additional compound of Edison’s, which we may exercise our option to select, for all indications, subject to the terms and conditions in the agreement. In the third quarter of 2009, Edison has not yet presented us with the additional compound. We expect to make a decision on our selection of this compound for selectionby the end of the third quarter.
     On May 5, 2009, we and Edison entered into an agreement under which Edison agreed that we could offset $550,000, and following that, the loan amount of $1.0 million plus accrued interest, against 50% of any future milestone and royalty payments, which may be due to Edison under the terms of the Edison Agreement. The loan amount is otherwise due and payable by Edison according to the original loan terms under the loan agreement. In addition, the agreement provides that we have no further contractual payment obligations in connection with the research period.

22


     A description of the Edison agreementAgreement is included under the caption “Collaborative and Licensing Agreements” in “Part I. Item 1. — Notes to Condensed Financial Statements”.Statements.”
     Nifedipine XL.Under a collaboration agreement with Mylan Pharmaceuticals Inc., or Mylan, we developed Nifedipine XL, a generic version of Procardia XL based on our TIMERx technology, thatwhich was approved by the FDA in December 1999. In March 2000, Mylan signed a supply and distribution agreement with Pfizer Inc., or Pfizer, to market Pfizer’s generic versions of all three strengths (30 mg, 60 mg, and 90 mg) of Procardia XL. In connection with that agreement, Mylan decided not to market Nifedipine XL, and as a result, Mylan entered into a letter agreement with us and agreed to pay us a royalty on all future net sales of the 30 mg strength of Pfizer’s generic Procardia XL. The term of the letter agreement continues until such time as Mylan permanently ceases to market Pfizer’s generic version of Procardia XL 30 mg.
Net Loss and Profitability
     We have incurred net losses since 1994 including net losses of $26.7 million, $34.5 million and $31.3 million during 2008, 2007 and 2006, respectively. For the threesix month period ended March 31,June 30, 2009, our net loss was $962,000.$3.1 million. As of March 31,June 30, 2009, our accumulated deficit was approximately $235$237 million. We currently generate revenues primarily from royalties received from Endo on Endo’s net sales of Opana ER and from Mylan on Mylan’s net sales of Pfizer’s generic version of Procardia XL 30 mg, revenues from our drug delivery technology collaborations and, to a lesser extent, from bulk sales of TIMERx material to Endo for use in Opana ER. We anticipate that, based upon our current operating plan, which contemplates a significant reduction in our operating expenses as compared with 2008 levels, and which includes expected royalties from third parties, we will achieve quarterly profitability in the fourth quarter of 2009. If we do not receive royalties from Endo for Opana ER in such amounts as forecasted and provided to us by Endo, or if we are unable to significantly reduce our operating

24


expenses, compared with 2008 levels, we may not be able to achieve quarterly profitability in the fourth quarter of 2009. However, even if we are able to achieve profitability on a quarterly basis, we may not be able to maintain it, or we may not be able to achieve profitability on an annual basis. Our future profitability will depend on numerous factors, including:
  the commercial success of Opana ER, and the amount of royalties from Endo’s sales of Opana ER, which may be adversely affected by any potential generic competition;
 
  our ability to successfully defend our intellectual property protecting our products;
 
  our ability to access funding support for our development programs from third party collaborators;
 
  the level of our investment in research and development activities, including the timing and costs of conducting clinical trials of our products;
 
  the level of our general and administrative expenses;
 
  the successful development and commercialization of product candidates in our portfolio and products being developed for collaborations; and
 
  royalties from Mylan’s sales of Pfizer’s generic version of Procardia XL 30 mg.
     Our results of operations may fluctuate from quarter to quarter depending on the amount and timing of royalties on Endo’s sales of Opana ER, Mylan’s sales of Pfizer’s generic version of Procardia XL 30 mg, the volume and timing of shipments of formulated bulk TIMERx material, including to Endo, the variations in payments under our collaborative agreements, and the amount and timing of our investment in research and development activities.
Critical Accounting Policies and Estimates
     The discussion and analysis of our financial condition and results of operations are based upon our condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and

23


expenses during the reporting periods. We base our estimates on historical experience and on various other factors that we believe to be reasonable under the circumstances. We regard an accounting estimate underlying our financial statements as a “critical accounting estimate” if the nature of the estimate or assumption is material due to the level of subjectivity and judgment involved, or the susceptibility of such matter to change, and if the impact of the estimate or assumption on our financial condition or performance may be material. We evaluate these estimates and judgments on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. Areas where significant judgments are made include, but are not limited to: revenue recognition, research and development expenses, deferred taxes-valuation allowance, impairment of long-lived assets and share-based compensation. For a more detailed explanation of the judgments we make in these areas, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2008.
Recent Accounting Pronouncements
     A detailed description of recent accounting pronouncements is included under the caption “Recent Accounting Pronouncements” in “Part I. Item 1. — Notes to Condensed Financial Statements”.Statements.”

25


Results of Operations for the Three and Six Month Periods Ended March 31,June 30, 2009 and 2008
Revenues
                                    
 Three months   Three months  Three months Three months Six months Six months 
 ended Percentage ended  ended Percentage ended ended Percentage ended 
 March 31, increase March 31,  June 30, increase June 30, June 30, increase June 30, 
 2009 (decrease) 2008  2009 (decrease) 2008 2009 (decrease) 2008 
 (In thousands, except percentages)  (In thousands, except percentages) 
Royalties $4,722  1,019% $422  $4,851  803% $537 $9,573  898% $959 
Product sales 180  (21) 228  158  (48) 302 338  (36) 530 
Collaborative licensing and development revenue 368 313 89  250  (48) 477 618 9 566 
              
Total revenues $5,270  613% $739  $5,259  300% $1,316 $10,529  412% $2,055 
              
     RoyaltiesOur royalties increased in the three and six month periodperiods ended March 31,June 30, 2009, as compared to the three and six month periodperiods ended March 31,June 30, 2008, reflecting that we did not begin to recognize royalties received from Endo on its net sales of Opana ER. We began to recognize royalties from Endo on sales of Opana ER untilfollowing the completion of the royalty holiday in the third quarter of 2008, following completion of the royalty holiday.2008. For the three and six month periodperiods ended March 31,June 30, 2009, we recognized $4.4 million and $8.8 million, respectively, in royalties from Endo. Partially offsetting these increased revenues were decreased royalties from Mylan as a result of a decrease in Mylan’s net sales of Pfizer’s generic version of Procardia XL 30 mg.
     Our product sales in the three and six month periods ended March 31,June 30, 2009 and 2008 consisted of sales of formulated TIMERx material to Endo for use in Opana ER. Under our agreement with Endo, the selling price of formulated TIMERx material is determined periodically based on our approximate costs, which may include patent enforcement litigation costs, and patent application and maintenance costs related to Opana ER, if not otherwise reimbursed to us by Endo. Product sales decreased in the 2009 three and six month periodperiods in comparison with the 2008 three and six month periodperiods due to a lower selling price of TIMERx material to Endo in the 2009 three and six month period,periods, which resulted following the Second Amendmentsecond and the Third Amendmentthird amendments to our agreement with Endo. In connection with the Second Amendment to our agreement thatsecond amendment, which we entered into with Endo in July 2008, the selling price of TIMERx material to Endo was reduced for the second half of 2008 to exclude the reimbursement of patent enforcement litigation costs we incurred related toin connection with Opana ER, for which Endo agreed to separately reimburse us for.us. In addition, in connection with the Third Amendment to our agreement thatthird amendment, which we entered into with Endo in March 2009 as discussed above, the selling price of TIMERx material to Endo was further reduced effective January 1, 2009 and for the remainder of 2009, to exclude the reimbursement of patent application and maintenance costs we incurred related toin connection with Opana ER, for which Endo agreed to separately reimburse us for.us. Partially offsetting the decreased revenue resulting from the lower selling prices was an increase in the volume of TIMERx material sold to Endo in the 2009 three and six month period asperiods, compared with the 2008 three and six month period.periods. We believe the level of product sales for each of the remaining quarters of 2009 will generally be lower than the average level of product sales for the threesix month period ended March 31, 2009.June 30, 2009 due to the timing of planned shipments to Endo.
     Revenue from collaborative licensing and development consists of the recognition of revenue relating to reimbursements of our expenses under our drug delivery technology collaborations and the recognition of revenue relating toon upfront payments from these

24


collaborations. The increasedecrease in revenue for the three month period ended March 31,June 30, 2009, as compared towith the three month period ended March 31,June 30, 2008, was primarily due to revenues earned on the increasedtiming of our development activity, reflecting a decreased level of development activity associated with the three collaboration agreementsunder our collaborations in placeprogress during the 2009 three month period, as described below under “Cost of Revenues,” and a related decrease in recognizable revenue. The increase in revenue for the six month period ended June 30, 2009, compared to one such agreementwith the six month period ended June 30, 2008, reflected overall increased development activity in placethe 2009 six month period, as described below under “Cost of Revenues,” and a related increase in recognizable revenue under our four collaborations in progress during the 2008 three2009 six month period.

26


Cost of Revenues
                                    
 Three months Percentage Three months  Three months Percentage Three months Six months Percentage Six months 
 ended increase ended  ended increase ended ended increase ended 
 March 31, 2009 (decrease) March 31, 2008  June 30, 2009 (decrease) June 30, 2008 June 30, 2009 (decrease) June 30, 2008 
 (In thousands, except percentages)  (In thousands, except percentages) 
Cost of royalties $113  438% $21  $95  111% $45 $207  218% $65 
Cost of product sales 181 135 77  143 39 103 325 80 181 
Cost of collaborative licensing and development revenue 360 407 71  230  (36) 360 590 37 431 
              
Total cost of revenues $654  287% $169  $468  (8)% $508 $1,122  66% $677 
              
     Cost of royalties consists of the amortization of deferred royalty termination costs associated with royalty termination agreements, and the amortization of certain patent costs associated with our TIMERx technology. The cost of royalties increased for the three and six month periodperiods ended March 31,June 30, 2009, as compared towith the three and six month periodperiods ended March 31,June 30, 2008, primarily as a result of increased amortization of the deferred royalty termination costs as a result of increased royalty revenues recognized in the 2009 three and six month period.periods.
     Cost of product sales consists of the costs related to sales of formulated TIMERx material, primarily to Endo. Cost of product sales increased for the three and six month periodperiods ended March 31,June 30, 2009, as compared towith the three and six month periodperiods ended March 31,June 30, 2008, primarily as a result of an increase in the volume of TIMERx material sold to Endo in the 2009 three and six month periodperiods for use in Opana ER.
     Cost of collaborative licensing and development revenue consists of our expenses under our drug delivery technology collaborations, which are generally reimbursed by our collaborators, and includes allocations of internal research and development, or R&D costs, including compensation and overhead costs associated with formulation activities under these collaborations, as well as contract and other outside service fees. These costs increaseddecreased for the three month period ended March 31,June 30, 2009, as compared towith the three month period ended March 31,June 30, 2008 and increased for the six month period ended June 30, 2009, compared with the six month period ended June 30, 2008, primarily due to the increased leveltiming of development activity underand our threeperformance obligations associated with the various stages of our collaboration agreements in place duringproject plans. The decrease for the 2009 three month period as comparedreflected a substantial level of activity in the 2008 three month period relating to one such agreementof our collaborations. The increase for the 2009 six month period, compared with the 2008 six month period, reflected overall increased development activity under our four collaborations in placeprogress during the 2009 six month period, compared with our one collaboration in progress during the 2008 threesix month period.
Selling, General and Administrative Expenses
             
  Three months  Percentage  Three months 
  ended  increase  ended 
  March 31, 2009  (decrease)  March 31, 2008 
  (In thousands, except percentages) 
Selling, general and administrative expenses $2,321   (46)% $4,324 
           
                         
  Three months  Percentage  Three months  Six months  Percentage  Six months 
  ended  increase  ended  ended  increase  ended 
  June 30, 2009  (decrease)  June 30, 2008  June 30, 2009  (decrease)  June 30, 2008 
  (In thousands, except percentages) 
                         
Selling, general and administrative expense $3,283   7% $3,071  $5,604   (24)% $7,395 
                     
     Selling, general and administrative, orThe increase in SG&A expenses for the three month period ended March 31,June 30, 2009, decreased as compared towith the three month period ended March 31,June 30, 2008 was attributable to the $1.1 million of expenses related to the proxy contest initiated by Tang Capital and Perceptive Life Sciences, and the related litigation. These increased expenses were partially offset by lower salary and benefits expenses as a result of the staff reductions that we implemented in January 2009 and the related lower share-based compensation expense, as discussed above. SG&A expenses for the six month period ended June 30, 2009 decreased, compared with the six month period ended June 30, 2008, primarily due to lower share-based compensation expense, which was largely due to a credit of $844,000 recorded in the first quarter of 2009 three month period, whichthat resulted from the forfeiture of stock options held by former employees in connection with our January 2009 staff reductions discussed above. The decrease also reflects the inclusion in SG&A expense in the first quarter of 2008 three month period of the impairment charge we recorded in the amount of $1.0 million that we recorded to establish a reserve against the

27


collectability of the loan that we made to Edison in February 2008 under the Edison agreement. These decreases were partially offset by the severance charge we recorded in the 2009 three month period, as discussed above, and additional$1.3 million of costs associated with the proxy contest in which we are involved.and the related litigation.
     As a result of the staff reductions implemented in January 2009, as discussed above, as well as other efforts to closely manage our cost structure, we expect cost savings to reduce our SG&A expenses over the course of 2009, as compared towith 2008. However, we expect the additional costs of our proxy contest to partially offsetand the costrelated litigation has reduced the savings from these efforts.we expected in 2009.

25


Research and Product Development Expenses
     Research and product development, or R&D expenses were $3.0$3.4 million and $6.4 million for the three and six month periodperiods ended March 31,June 30, 2009, a decrease of $3.4respectively, compared with $4.5 million as compared to $6.4and $10.9 million for the three and six month periodperiods ended March 31, 2008. This decrease reflectsJune 30, 2008, respectively. The decreases reflect that forin the 2009 three and six month period,periods ended June 30, 2009, we made no contractual payments to Edison under the Edison agreement, we incurred no expenses related to the development of nalbuphine ER, we had lower compensation expenses due to staff reductions implemented in Marchthe first quarter of 2008 and the first quarter of 2009, and we recorded increased allocations of internal R&D costs related to our drug delivery technology collaborations, as noted above in “Cost of Revenues”, to cost of collaborative licensing and development revenue. These lower costs were offset by additional expenses for preclinical and clinical work conducted on A0001 in the three and six month periods ended June 30, 2009.
In the table below, R&D expenses are set forth in the following categories:
            
 Three months Percentage Three months                         
 ended increase ended  Three months Percentage Three months Six months Percentage Six months 
 March 31, 2009 (decrease) March 31, 2008  ended increase ended ended increase ended 
 (In thousands, except percentages)  June 30, 2009 (decrease) June 30, 2008 June 30, 2009 (decrease) June 30, 2008 
  (In thousands, except percentages) 
A0001 and Edison Payments $998  (54)% $2,180  $1,521  5% $1,454 $2,519  (31)% $3,634 
Nalbuphine ER   (100) 1,116    (100) 519   (100) 1,635 
Other Phase I Products and Internal Costs 2,008  (35) 3,089  1,904  (25) 2,551 3,912  (31) 5,640 
              
Total Research and Product Development Expense $3,006  (53)% $6,385  $3,425  (24)% $4,524 $6,431  (41)% $10,909 
              
In the preceding table, research and product development expenses are set forth in the following categories:
  A0001 and Edison Payments —These expenses reflect our direct external expenses relating to the development of A0001, and for the three and six month periodperiods ended March 31,June 30, 2008, they also reflect our funding of Edison’s research activities under the Edison agreement. These expenses approximated 33%44% and 39%, respectively, of our R&D expenses for the three and six month periodperiods ended March 31,June 30, 2009.
 
   In May 2008, we submitted an IND for A0001 for the treatment of symptoms associated with inherited mitochondrial respiratory chain diseases. In July 2008, we initiated a Phase Ia placebo-controlled, single ascending dose trial designed to evaluate the safety and tolerability of A0001 in healthy subjects, and to collect pharmacokinetic data. A0001 was well tolerated by all subjects across all dose groups and there were no drug-related serious adverse events. In FebruaryJune 2009, we initiatedcompleted a Phase Ib multiple ascending dose clinicalsafety study of A0001 in healthy subjects. The study isIn the Phase Ib trial, the drug was well tolerated by subjects and no serious adverse events were reported. There was a single-blind, placebo-controlled, multiple ascending dose clinical trialdose-dependent increase in healthy subjects, designedexposure approaching steady state within two to assess the safety, tolerability and pharmacokinetics of A0001four days following repeat dosing, in healthy male and female subjects. Wea maximum tolerated dose was established. Based on these results, we plan to enroll a total of approximately 30 healthy subjectsadvance A0001 into Phase IIa studies in patients with mitochondrial diseases in the trial. We expect that results from this study will be available in the secondfourth quarter of 2009. If A0001 demonstrates an acceptable safety profile and tolerability in this Phase Ib study, we planWe intend to commence atwo Phase IIa trials — one trial infocused on patients with inheritedFriedreich’s Ataxia and another trial focused on patients with the A3243G mitochondrial respiratory chain diseasesDNA point mutation associated with MELAS syndrome. The goal of these trials will be to determine if A0001 has biological activity and we expect data from both of these trials in the secondfirst half of 2009. We are currently working on the study design for the Phase IIa program.2010. In parallel with the Phase Ib trial, we have initiated long-term animal toxicology studies to support the clinical program.program, which we expect to complete by the fourth quarter of 2009.

28


   We expect our A0001 costsand Edison Payments expenses to decline infor 2009 as compared towith our costs infor 2008, as the quarterly contract research payments to Edison were completed by the end of 2008. In the third quarter of 2009, Edison presented us with an additional compound. We expect to make a decision on our selection of this compound by the end of the third quarter. If we select this additional compound, we would be obligated to make a milestone payment to Edison in the amount of $250,000, after the 50% reduction provided for under the May 5, 2009 agreement, as described above. We cannot reasonably estimate or know the nature, timing andor estimated costs of the efforts necessary to complete the development of A0001 due to the numerous risks and uncertainties associated with developing and commercializing drugs.
 
  Nalbuphine ER— These expenses reflect our direct external expenses relating to the development of nalbuphine ER. In the three and six month periodperiods ended March 31,June 30, 2008, these expenses consisted primarily of payments to third parties in connection with clinical trials of nalbuphine ER, which were underway. FollowingAfter the endcompletion of the Phase IIa trial in the first quarter of 2008, three month period, we determined to seek a collaborator for the further development and commercialization of nalbuphine ER, and not to conduct any additional development work until we enter into such a collaboration. As a result, we did not incur any R&D

26


expenses in the three and six month periodperiods ended March 31,June 30, 2009, and we do not expect to incur any additional R&D expenses for nalbuphine ER, unless we find a collaborator to continue the development work.
 
  Other Phase I Products and Internal Costs— These expenses reflect internal and external expenses not separately reported under a product development program noted above and include the areas of pharmaceutical development, clinical and regulatory. The types of expenses included in internal expenses primarily are salary and benefits, share-based compensation costs, depreciation on purchased equipment, and the amortization or any write-downs of patent costs, other than product patent write-offs charged directly to a separately reported product development program or amortization of patent costs relating to commercialized products, which are included in cost of revenues. The types of expenses included in external expenses are primarily related to preclinical studies, proof-of-principle biostudies conducted on our Phase I product candidates and payments to third parties for drug active. These costs decreased in the three and six month periodperiods ended March 31,June 30, 2009, as compared towith the three and six month periodperiods ended March 31,June 30, 2008, primarily as a result of lower compensation expenses in the three month period ended March 31, 2009 due to staff reductions implemented in March 2008 and in January 2009, allocations of internal costs related to our drug delivery technology collaborations to cost of collaborative licensing and development revenues.revenues, and lower Phase I product expenses, as we did not incur any external expenses on these product candidates.
     We evaluate product candidates on an ongoing basis and may terminate or accelerate development of product candidates based on study results, product development risk, commercial opportunity, perceived time to market and other factors. As a result of the staff reductions implemented in January 2009, as discussed above, as well as other efforts to closely manage our cost structure, including our focus on advancing the development of A0001, we expect both our internal and external R&D expenses over the course of 2009 to continue to decline as compared towith 2008.
     There can be no assurance that any of our product candidates will advance through or into the clinical development process and be successfully developed, will receive regulatory approval, or will be successfully commercialized. Completion of clinical trials and commercialization of these product candidates may take several years, and the length of time can vary substantially according to the type, complexity and novelty of a product candidate. Due to the variability in the length of time necessary to develop a product, the uncertainties related to the estimated cost of the development process and the uncertainties involved in obtaining governmental approval for commercialization, accurate and meaningful estimates of the ultimate cost to bring our product candidates to market are not available.

29


Share-Based Compensation
     We recognized share-based compensation in our statements of operations as follows:
                        
 Three Months Ended  Three Months Ended Six Months Ended 
 March 31,  June 30, June 30, 
 2009 2008  2009 2008 2009 2008 
 (Unaudited) (In thousands)  (In thousands) 
Selling, general and administrative $(568) $681  $266 $526 $(302) $1,207 
Research and product development 164 234  151 215 315 450 
              
Total share-based compensation $(404) $915  $417 $741 $13 $1,657 
              
     The decrease in total share-based compensation expense in the three month period ended March 31,June 30, 2009, as compared towith the three month period ended March 31,June 30, 2008, is primarily attributable to lower average fair values associated with outstanding stock options and restricted stock in the 2009 three month period, as a result of decreases in the market price of our common stock, and a reduction in the number of outstanding stock options in the 2009 three month period, as a result of the forfeiture of employee stock options in the first quarter of 2009 due to the January 2009 staff reductions.
     The decrease in total share-based compensation expense in the six month period ended June 30, 2009, compared with the six month period ended June 30, 2008, is primarily attributable to credits of approximately $885,000 recorded in the first quarter of 2009 three month period under SFAS No. 123R associated with the forfeiture of employee stock options as a result ofdue to the January 2009 staff reductions. Such forfeitures also resulted in decreased expense in the 2009 six month period due to a reduction in the number of outstanding stock options in such period. The decrease was also partially attributable to lower average fair values associated with outstanding stock options and restricted stock in the 2009 threesix month period, primarily as a result of decreases in the market price of the our common stock.
Tax Rates
     TheOur effective tax rates for the three and six month periods ended March 31,June 30, 2009 and 2008 were zero. TheOur effective tax rates differ from the federal statutory rate of a 34% benefit primarily due to valuation allowances recorded to offset deferred tax assets relating to our net operating losses.

27


Liquidity and Capital Resources
Sources of Liquidity
     Since 1998, when we became an independent, publicly owned company, we have funded our operations and capital expenditures from the proceeds of the sale and issuance of shares of common stock, sales of excipients, the sale of our excipients business, sales of formulated bulk TIMERx material, royalties and milestone payments from Endo, Mylan and other collaborators, and advances under credit facilities. As of March 31,June 30, 2009, we had cash, cash equivalents and short-term investments of approximately $15.0$12.7 million.
     Private Placement.On March 11, 2008, we sold units representing an aggregate of 8,140,600 shares of our common stock, $0.001 par value per share, together with warrants to purchase an aggregate of 4,070,301 shares of our common stock, in a private placement, for a total purchase price of approximately $25.1 million. We received net proceeds of approximately $23.1 million from this private placement, after deducting the placement agent’s fees and other expenses. The warrants are exercisable on or prior to March 11, 2013 at an exercise price of $3.62 per share. The warrants may also be exercised pursuant to cashless exercise provisions under certain circumstances.
     Pursuant to the securities purchase agreement entered into in connection with the private placement, we filed a registration statement with the Securities and Exchange Commission, or SEC, on April 10, 2008, registering for resale the shares sold in the private placement and shares issuable under the warrants. This registration statement was declared effective by the SEC on April 28, 2008. We have agreed to use our reasonable best efforts to maintain the registration statement’s effectiveness until the earlier of (i) the later of (A) March 11, 2009, and (B) the twelve month anniversary of the last date on

30


which warrant shares are issued upon exercise of warrants and (ii) the date all of the shares and warrant shares have been resold by the original purchasers.
     Senior Secured Credit Facility.On March 13, 2007, we entered into a $24.0 million senior secured credit facility with Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., which was acquired by GE Capital in February 2008, and is now known as GE Business Financial Services Inc. The credit facility consists of: (i) a $12.0 million term loan advanced upon the closing of the credit facility and (ii) a $12.0 million term loan that we had the right to access until September 15, 2008, subject to conditions specified in the credit agreement. We did not access the second $12.0 million term loan prior to September 15, 2008, at which time it expired in accordance with the terms of the agreement.
     Our outstanding term loan has a term of 42 months from the date of advance, with interest-onlyadvance. Interest-only payments were due for the first nine months; interest plus monthly principal payments equal to 1.67% of the loan amount were due for the period from the end of the interest-only period through December 2008; and interest plus straight line amortization payments with respect to the remaining principal balance are due for the remainder of the term, through its maturity date in September 2010.
     The interest rate on our outstanding term loan is fixed at 10.32%. At the time of final payment of the loan, we will pay an exit fee of 3.0% of the original principal loan amount. Should any prepayment occur, we are alsowould be required to pay a prepayment penaltiespenalty of 3.0% of any prepaid amount in the first year, 2.0% of any prepaid amount in the second year and 1.0% of any prepaid amount thereafter.amount. As of March 31,June 30, 2009, $8.2$6.9 million of the term loan was outstanding. Beginning January 2008, we began making monthly principal payments on this loan, in addition to the monthly interest payments. Beginning January 2009, the principal portion of our payments increased from their 2008 level to reflect the straight linestraight-line amortization of the remaining principal amount outstanding, as noted above. The principal payments are expected to total approximately $4.1$2.7 million over the remaining threetwo quarters of 2009. Based on the terms of the credit facility, the loan amount currently outstanding will be fully paid by September 2010.
Cash Flows
     We had negative cash flow from operations for the threesix month period ended March 31,June 30, 2009 of $311,000,$1.5 million, primarily due to a net loss of $962,000$3.1 million in the period, which included a net non-cash credit of $404,000 for share-based compensation and non-cash charges of $328,000$636,000 for depreciation and amortization. Cash flow from operations also reflected $465,000$525,000 in increased accounts payable and accrued expenses.expenses, and $511,000 in decreased prepaid expenses and other current assets.

28


     Net cash used in investing activities was $545,000$314,000 for the threesix month period ended March 31,June 30, 2009, primarily reflecting purchases of marketable securities of $499,000. NetPartially offsetting this use of cash usedwere the reimbursements of patent costs by investing activities also reflected funds expended to secure patents on technology we have developed and purchasesEndo in the amount of fixed assets.$229,000. Net cash used by financing activities was $1.4$2.7 million, reflecting the repayments of principal on our outstanding term loan described above.
Funding Requirements
     We anticipate that, based upon our current operating plan, our existing capital resources, together with expected royalties from third parties, will be sufficient to fund our operations on an ongoing basis through at least 2010. If, however, we do not receive royalties from Endo for Opana ER in such amounts as we anticipate, we may not be able to fund our ongoing operations through at least 2010, without seeking additional funding from the capital markets.
     We have taken measures to reduce our spending and to manage our costs more closely, including the staff reductions that we implemented in January 2009 as described above, and have established a narrowed set of priorities for 2009, which recognizein recognition of our limited financial resources and the challenging environment in which we operate. We arehave however, incurringincurred significant unplanned costs in connection with an ongoingour shareholder proxy contest.contest and the related litigation. These costs, are difficult to predict but, we currently estimate total expenses, including legal and other advisory fees, totaled $1.3 million in connection with the proxy solicitation to be $875,000, which includes currentsix month period ended June 30, 2009, and included costs of litigation relating to suitsthree lawsuits brought by the dissident shareholders. The costsshareholders who initiated the proxy contest, one of which lawsuits is still pending. Costs of litigation are difficult to project. As a result, our legal expenses could increase depending on the course of the litigation.

31


     We are also seeking to enter into collaboration and licensing agreements for the development and marketing of Opana ER in territories outside the United States and for nalbuphine ER, and to enter into additional drug delivery technology collaborations. These collaborations may provide additional funding for our operations.
     We expect that our capital expenditures in 2009 towill not exceed approximately $250,000.$150,000.
     On May 7, 2009, we received notice from Draxis Specialty Pharmaceuticals Inc., or Draxis, our contract manufacturer of TIMERx material, that as a result of its decision to cease manufacturing of solid dosage form products in the facility in which TIMERx material is currently manufactured, it will not renew our manufacturing agreement upon the expiration of the current term in November 2009. As a result of this, we plan to increase our existing inventory levels of TIMERx material during the remaining threetwo quarters of 2009, which will require additional use of our cash resources. We are currently workingexploring with Endo on various manufacturing alternatives, including the qualification of another manufacturer.
     We believe that there are a limited number of manufacturers that comply with cGMP regulations who are capable of manufacturing our TIMERx materials. As Draxis has indicated that it intends to discontinue with oral solid production, which includes our TIMERx material, we may not be able to obtain alternative contract manufacturing or obtain such manufacturing on commercially reasonable terms. In addition, if we are unable to enter into longer-term manufacturing arrangements for our products on acceptable terms, particularly as drug candidates advance through clinical development and move closer to regulatory approval, our business and the development and commercialization of our products could be materially adversely affected.
     Requirements for capital in our business are substantial. Our potential need to seek additional funding will depend on many factors, including:
  the commercial success of Opana ER, and the amount of royalties from Endo’s sales of Opana ER, which may be adversely affected by any potential generic competition;
 
  the prosecution, defense and enforcement of our patents and other intellectual property rights, such as our Orange Book listed patents for Opana ER, and the prosecution by us and Endo of additional patent applications with respect to Opana ER;
 
  the timing and amount of payments received under collaborative agreements, including our agreement with Mylan with respect to Pfizer’s generic version of Procardia XL 30 mg;
 
  the timing and amount of our internal costs of development for drug candidates for which we acquire rights under the Edison agreement;
 
  the progress of our existing development projects and any development projects we may undertake, funding obligations with respect to the projects and the related costs to us of clinical studies for our product candidates;

29


  our ability to enter into new collaborations for Opana ER outside the United States nalbuphine ER and our drug delivery technologies, and the structure and terms of any such agreements;

32


  our ability to access funding support for development programs from third party collaborators;
 
  the level of our investment in capital expenditures for facilities or equipment;
 
  the timing and amount of our costs in connection with our proxy contest andof the shareholder lawsuits filed against us and our directors;directors in connection with our proxy contest; and the costs of any future proxy contests which may occur;
 
  our success in reducing our spending and managing our costs.
     If we accelerate the development of any of our own product candidates, we will need to seek additional funding through collaborative agreements, the selling of assets, or public financings of equity or debt securities.
     We plan to meet our long-term cash requirements through our existing levels of cash and marketable securities, andour revenues from collaborative agreements, as well as through equity or debt financings. On September 26, 2008, we filed a registration statement on Form S-3 with the SEC, which became effective on October 30, 2008. This shelf registration statement covers the issuance and sale by us of any combination of common stock, preferred stock, debt securities and warrants having an aggregate purchase price of up to $75 million. No securities have been issued under this shelf registration statement.
     If we raise additional funds by issuing equity securities, further dilution to our then-existing shareholders may result. Additional debt financing, such as the credit facility noted above, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt or equity financing may contain terms, such as liquidation and other preferences, that are not favorable to us or our shareholders. If we raise additional funds through collaboration and licensing arrangements, or research and development arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, research programs or potential products, or grant licenses on terms that may not be favorable to us.
     We cannot be certain that additional financing will be available in amounts or on terms acceptable to us, if at all. Under the current economic environment, market conditions have made it very difficult for companies likesuch as ours to obtain equity or debt financing. We believe that any such financing that we could conduct would be on significantly unfavorable terms. If we seek but are unable to obtain additional financing, we may be required to delay, reduce the scope of, or eliminate one or more of our planned research, development and commercialization activities, including our planned clinical trials, which could harm our financial condition and operating results.
Contractual Obligations
     Our outstanding contractual cash obligations include obligations under our operating leases primarily for facilities in Danbury, CT and Patterson, NY, purchase obligations primarily relating to preclinical and clinical development, drug delivery technology collaboration obligations, payments due under our credit facility relating to interest, principal and exit fees, and obligations under deferred compensation plans as discussed below. Following is a table summarizing our contractual obligations as of March 31,June 30, 2009 (in thousands).
                                        
 Less Than 1-3 4-5 After 5  Less Than 1-3 4-5 After 5 
 Total One Year Years Years Years  Total One Year Years Years Years 
Operating leases $618 $618 $ $ $  $412 $412 $ $ $ 
Purchase obligations 4,093 4,093     3,193 3,193    
Payments due under credit facility 9,268 6,082 3,186    7,693 5,938 1,755   
Deferred compensation, including current portion 2,682 294 587 587 1,214 
Deferred compensation 2,541 294 587 587 1,073 
                      
Total $16,661 $11,087 $3,773 $587 $1,214  $13,839 $9,837 $2,342 $587 $1,073 
                      
     We lease approximately 15,500 square feet of office, and research and development space in Patterson, New York. In January 2009, we exercised our 10 month renewal option through December 31, 2009. The additional commitment under this lease is included in the table above.

3033


     Deferred compensation, including current portion, reflects the commitments described below:
  We have a Supplemental Executive Retirement Plan, or SERP, a nonqualified plan which covers our former Chairman and Chief Executive Officer, Tod R. Hamachek. Under the SERP, effective in May 2005, we became obligated to pay Mr. Hamachek approximately $12,600 per month over the lives of Mr. Hamachek and his spouse.
 
  We also have a Deferred Compensation Plan, or DCP, a nonqualified plan which covers Mr. Hamachek. Under the DCP, effective in May 2005, we became obligated to pay Mr. Hamachek approximately $140,000 per year, including interest, in ten annual installments. However, these installments are recalculated annually based on market interest rates as provided for under the DCP.
     We do not fund these liabilities, and no assets are held by the plans. However, we have two whole-life insurance policies in a rabbi trust, the cash surrender value or death benefits of which are held in trust for the SERP and DCP liabilities. Mr. Hamachek’s SERP and DCP benefit payments are being made directly from the assets in the trust. As of March 31,June 30, 2009, the trust assets consisted of the cash surrender value of these life insurance policies totaling $1,946,000$1,969,000 and $262,000$77,000 held in a money market account.
     Under the terms of our Edison agreement, we are obligated to make milestone payments to Edison upon the achievement of certain clinical and regulatory events. We will not be responsible for the payment of future milestone and/or royalty payments in the event that the development program is discontinued and the agreement is terminated prior to the achievement of these events. Preclinical and clinical development of drug candidates is a long, expensive and uncertain process. At any stage of the preclinical or clinical development process, we may decide to discontinue the development of A0001 or other drug candidates under the Edison agreement.Agreement. The contractual obligations listed in the table above do not include any such future potential milestone or royalty payments to Edison.Edison, including the payment we would be obligated to make to Edison in the amount of $250,000, if we decide to select the compound Edison presented to us in the third quarter of 2009.
Net Operating Loss Carryforwards
     We have determined that an ownership change occurred in 2008 under Section 382 of the Internal Revenue Code. As a result, the utilization of our net operating loss, or NOL, carryforwards and other tax attributes through the date of ownership change will be limited to approximately $2.8 million per year over the next 20 years into 2028. We also determined that we were in a Net Unrealized Built-In Gain position (for purposes of Section 382 of the Internal Revenue Code) at the time of the ownership change, which increases our annual limitation over the next five years into 2013 by approximately $3.4 million per year. Accordingly, we have reduced our NOL carryforwards, and research and development tax credits to the amount that we estimate that we will be able to utilize in the future, if profitable, considering the above limitations. In accordance with FAS 109, “Accounting for Income Taxes,” we have provided a valuation allowance for the full amount of our net deferred tax assets because it is not more likely than not that we will realize future benefits associated with deductible temporary differences and NOLs at March 31,June 30, 2009, and at December 31, 2008 and 2007.2008.
     At December 31, 2008, we had federal NOL carryforwards of approximately $91.3 million for income tax purposes, which expire at various dates beginning in 2018 through 2028. At December 31, 2008, we had state NOL carryforwards of approximately $90.4 million, which expire at various dates beginning in 2023 through 2028. In addition, we had federal research and development tax credit carryforwards of approximately $485,000, which expire in 2028. The NOL’sNOLs incurred in 2008, subsequent to the 2008 ownership change of $18.8 million are not limited on an annual basis. Pursuant to Section 382 of the Internal Revenue Code, subsequent ownership changes could further limit this amount and other NOL’sNOLs incurred subsequent to the 2008 ownership change. The use of the NOL carryforwards, and research and development tax credit carryforwards are limited to our future taxable earnings.
     For financial reporting purposes, at December 31, 2008 and 2007, respectively, valuation allowances of $40.6 million and $72.6 million have been recognized to offset net deferred tax assets, primarily attributable to our NOL carryforwards. As previously noted, in 2008, we reduced our tax attributes (NOL’s(NOLs and tax credits) as a result of our ownership change under Section 382 of the Internal Revenue Code and the limitation placed on the utilization

34


of our tax attributes, as a substantial portion of the NOL’sNOLs and tax credits generated prior to the ownership change will likely expire unused. Accordingly, the NOL’sNOLs were reduced by $123.3 million and the tax credits were reduced

31


by $6.6 million upon the ownership change in 2008. The changes in the valuation allowance for the years ended December 31, 2008, 2007 and 2006 were a decrease of approximately $32.0 million due primarily to the limitations placed on the utilization of our tax attributes as noted above, and an increase of $9.9 million and $14.3 million, respectively.
Item 3.Quantitative and Qualitative Disclosures About Market Risk
Market Risk and Risk Management Policies
     Market risk is the risk of loss to future earnings, to fair values or to future cash flows that may result from changes in the price of a financial instrument. The value of a financial instrument may change as a result of changes in interest rates, foreign currency exchange rates and other market changes. Market risk is attributed to all market sensitive financial instruments, including debt instruments. Our operations are exposed to financial market risks, primarily changes in interest rates. Our outstanding term loan under our credit facility is at a fixed rate of interest and therefore, we do not believe that there is significant exposure to changes in interest rates under the term loan. Our interest rate risk primarily relates to our investments in marketable securities.
     The primary objectives for our investment portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return, consistent with these two objectives. Our investment policy limits investments to specific types of instruments issued by institutions with investment grade credit ratings and places certain restrictions on maturities and concentration by issuer.
     At March 31,June 30, 2009, our marketable securities consisted primarily of corporate debtcommercial paper and approximated $500,000. These marketable securities had maturity dates of up to four months.one month. Due to the relatively short-term maturities of these securities, management believes they have no significant market risk. At March 31,June 30, 2009, market values approximated carrying values. Due to the nature of our cash equivalents, which are money market accounts at March 31,June 30, 2009, management believes they have no significant market risk. As of March 31,June 30, 2009, we had approximately $15.0$12.7 million in cash, cash equivalents and marketable securities, and accordingly, a sustained decrease in the rate of interest earned of 1% would have caused a decrease in the annual amount of interest earned of up to approximately $150,000.$127,000.
Item 4.Controls and Procedures
     (a) Evaluation of Disclosure Controls and Procedures.Our management, with the participation of our chief executive officer (who is acting as our chief financial officer), evaluated the effectiveness of our disclosure controls and procedures as of March 31,June 30, 2009. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (or the Exchange Act) 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 Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the U.S. Securities and Exchange Commission’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 Exchange Act 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. 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 the evaluation of our disclosure controls and procedures as of March 31,June 30, 2009, our chief executive officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
     (b) 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 March 31,June 30, 2009 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

3235


PART II — OTHER INFORMATION
Item 1.Legal Proceedings
     Impax ANDA Litigation
     On October 3, 2007, we received a letter from IMPAX notifying us of the filing by IMPAX of an ANDA containing a Paragraph IV certification under 21 U.S.C. § 355(j) for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. This Paragraph IV certification notice referred to our patent, U.S. Patent No. 7,276,250, which covers the formulation of Opana ER and was listed in the Orange Book as of October 2, 2007. On October 4, 2007, IMPAX announced in a press release that the FDA had rescinded the acceptance of IMPAX’s ANDA filing. On November 5, 2007, we received a letter from IMPAX notifying it of additional Paragraph IV certifications relating to our patents, U.S. Patent Nos. 5,622,933 and 5,958,456, which were listed in the Orange Book as of October 19, 2007. On November 15, 2007, Endo and us filed a lawsuit against IMPAX in the U.S. Dist. Delaware. The lawsuit against IMPAX not only alleged infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 but also sought declaratory judgment that, among other things, IMPAX had no legitimate basis to trigger the Hatch-Waxman ANDA patent litigation process because the FDA, according to IMPAX, had rescinded its acceptance of IMPAX’s ANDA. It further asked the court to declare that the Paragraph IV certification notices that IMPAX served on Endo and us are null, void and of no legal effect. On December 14, 2007, we received a letter from IMPAX notifying us of a refiling of its ANDA for Opana ER that was accepted by the FDA as of November 23, 2007. The notice letter states that IMPAX’s ANDA contains Paragraph IV certifications for the three patents noted above and that the FDA had required IMPAX to notify Endo and us of these certifications. In this notice, IMPAX also stated that it would not withdraw its prior Paragraph IV certification notices because it believed they were properly provided and because IMPAX was continuing to seek to convince the FDA to assign an earlier filing date to its ANDA. As a result of the FDA’s determination of IMPAX’s ANDA filing date and the receipt of the new Paragraph IV certification notice, on December 20, 2007, we and Endo filed a notice of dismissal of the portion of its November 15, 2007 complaint seeking declaratory judgment that, among other things, IMPAX had no basis to trigger the Hatch-Waxman ANDA patent litigation process and that any Paragraph IV certification notices served prior to November 23, 2007 were null, void and of no legal effect. We and Endo did not dismiss the patent infringement claims because IMPAX refused to withdraw its prior Paragraph IV certification notices. On January 25, 2008, we and Endo filed a lawsuit against IMPAX in U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 in response to IMPAX’s December notice. Given the FDA’s acceptance of IMPAX’s ANDA as of November 23, 2007, we believe that we are entitled to a 30-month stay under the Hatch-Waxman Act beginning on December 14, 2007.
     On or around June 14, 2008, we and Endo each received a notice from IMPAX advising us and Endo that IMPAX had amended its ANDA for Opana ER to include three additional strengths, 7.5 mg, 15 mg and 30 mg. This ANDA amendment contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On July 25, 2008, we and Endo filed a lawsuit against IMPAX in U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456 in response to the notice. We believe that we are entitled to a 30-month stay under the Hatch-Waxman Act beginning on June 14, 2008 with respect to IMPAX’s amended ANDA for 7.5 mg, 15 mg and 30 mg.
     In January 2009, the cases against IMPAX were reassigned to the U.S. Dist. NJ.
     Actavis ANDA Litigation
     On or around February 14, 2008, we received a notice from Actavis advising of the filing by Actavis of an ANDA containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. The Actavis Paragraph IV certification notice refers to our Orange Book listed patents, U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456 and 7,276,250, which cover the formulation of Opana ER. These patents expire(d) in 2008, 2013, 2013 and 2023, respectively. On March 28, 2008, we and Endo filed a lawsuit against Actavis in the U.S. Dist. NJ, alleging infringement of U.S. Patent No. 5,958,456. On June 2, 2008, we and Endo each received a notice from Actavis advising us and Endo that Actavis had amended its ANDA for Opana ER to include two additional strengths, 7.5 mg and 15 mg. On July 2, 2008, we and Endo each received a third notice

36


from Actavis advising that Actavis had further amended its ANDA to include the 30 mg strength. Each ANDA

33


amendment contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456 and 7,276,250. On July 11, 2008, we and Endo filed a lawsuit against Actavis in the U.S. Dist. NJ alleging infringement of U.S. Patent No. 5,958,456 based on these two additional Paragraph IV certification notices from Actavis. We believe we are entitled to a 30-month stay with respect to Actavis’ ANDA covering Opana ER 5 mg, 10 mg, 20 mg and 40 mg beginning February 14, 2008, with respect to Actavis’ amended ANDA covering Opana ER 7.5 mg and 15 mg beginning June 2, 2008 and against its amended ANDA covering Opana ER 30 mg beginning July 2, 2008.
     On February 20, 2009, we and Endo settled all of the Actavis litigation. Both sides agreed to dismiss their respective claims and counterclaims with prejudice. Under the terms of the settlement, Actavis agreed not to challenge the validity or enforceability of our four Orange Book-listed patents. We and Endo agreed to grant Actavis a license under US Patent No. 5,958,456 and a covenant not to sue for its generic formulation of Opana ER under our four Orange Book-listed patents. The license and covenant not to sue will take effect on July 15, 2011, and earlier under certain circumstances.
     The settlement is subject to the review of the U.S. Federal Trade Commission and Department of Justice.
     Sandoz ANDA Litigation
     On or around July 10,14, 2008, we and Endo each received a notice from Sandoz advising us and Endo that Sandoz had filed with the FDA an ANDA for Opana ER in four strengths, 5 mg, 10 mg, 20 mg and 40 mg. This ANDA contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On August 22, 2008, we and Endo filed a lawsuit against Sandoz in the U.S. Dist. Delaware, alleging infringement of U.S. Patent No. 5,958,456 in response to this notice.
     On or around November 20, 2008, we and Endo received a notice from Sandoz that it had filed an amendment to its ANDA containing Paragraph IV certifications for the 7.5 mg, 15 mg and 30 mg dosage strengths of oxymorphone hydrochloride extended release tablets. The notice covers our U.S. Patent Nos. 5,128,143, 7,276,250, 5,958,456 and 5,662,933. On December 30, 2008, we and Endo filed suit against Sandoz in the U.S. Dist. NJ. The lawsuit alleges infringement of an Orange Book-listed U.S. patent that covers the Opana® ER formulation. In response, Sandoz filed an answer and counterclaims, asserting claims for declaratory judgment that the patents listed in the Orange Book are invalid, not infringed and/or unenforceable. We cannot predict the outcome of this litigation. We and Endo intend to pursue all available legal and regulatory avenues in defense of Opana® ER, including enforcement of our intellectual property rights and approved labeling.
     In January 2009, the casescase against Sandoz werewas reassigned to the U.S. Dist. NJ.
     Barr ANDA Litigation
     On or around September 12, 2008, we and Endo each received a notice from Barr advising us and Endo that Barr had filed with the FDA an ANDA for Opana ER in 40 mg. On September 13, 2008, we and Endo received an additional notice that Barr’s ANDA was amended to include the strengths of 5 mg, 10 mg and 20 mg. Barr’s ANDA as amended contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On October 20, 2008, we and Endo filed a lawsuit against Barr in the U.S. Dist. Delaware, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456. In January 2009, the cases against Barr were reassigned to the U.S. Dist. NJ.
     On or around June 2, 2009, we and Endo received an additional notice that Barr’s ANDA was amended to include the strengths of 7.5 mg, 15 mg and 30 mg. Barr’s ANDA, as amended, contained a Paragraph IV certification against our Orange Book listed patents, U.S. Patent Nos. 5,662,933, 5,958,456 and 7,276,250. On July 2, 2009, we and Endo filed a lawsuit against Barr in the U.S. Dist. NJ, alleging infringement of U.S. Patent Nos. 5,662,933 and 5,958,456

37


Tang/Edelman Shareholder Claim
     Tang Capital and Perceptive Life Sciences, or Tang Capital and Perceptive, our two largest shareholders have provided notice that they intend to nominate and solicit proxies for their own nominees for election as directors at this year’s annual meetingeach of shareholders scheduled for June 10, 2009 and to make a numberwhich owns more than 5% of shareholder proposals for consideration at the meeting.
     In connection with their proxy battle, Tang Capital and Perceptiveour outstanding securities, have brought three suitslawsuits against us seeking injunctive relief,us. Following the dismissal of the two Thurston County actions and the amendment of which are stillthe complaint in King County, as discussed below, one suit remains pending.
     On March 12, 2009, Tang Capital and Perceptive brought suit against us in the Superior Court of the State of Washington, Thurston County (Tang Capital Partners, et al. v.Penwest Pharmaceuticals Co., No. 09-2-00617-0), seeking declaratory and injunctive relief to uphold their claims that their nomination notice had satisfied the requirements set forth in our bylaws and requesting that the court issue an order preventing us from seeking to disallow or otherwise prevent or not recognize their nominations, or the casting of votes in favor of their designees, on the basis that they had not complied with the provisions of our bylaws or applicable state law. On March 13, 2009, Tang Capital and Perceptive moved for a preliminary injunction to enjoin us from mailing any ballots to shareholders that contain provisions to vote for director nominees and enjoining any shareholder vote on individuals nominated for the board of directors unless the three designees of Tang Capital and Perceptive are permitted to be nominated and votes are permitted to be cast in their favor, or a court resolves the merits of their declaratory

34


judgment action described above. On March 20, 2009, we confirmed in writing that Tang Capital and Perceptive’s nomination notice had been timely received and that, assuming the accuracy and completeness of the information contained in their notice, their notice in all other respects met the requirements of our bylaws in regard to notices of intention to nominate. On March 23, 2009, Tang Capital and Perceptive withdrew their motion for injunctive relief, and on April 10, 2009, they voluntarily dismissed the suit.
     On April 21,20, 2009, Tang Capital and Perceptive brought suit against us in the Superior Court of the State of Washington, King County, (Tang Capital Partners, et al. v. Penwest Pharmaceuticals Co.), seeking to enforce their alleged rights under the Washington Business Corporation Act to inspect certain Company documents. Our position is that certain of the requested documents are outside the scope of documents for which the Washington Business Corporation Act permits a statutory inspection right and that certain of the conditions to qualify for statutory inspection rights have not been satisfied. A schedule for resolution of this claim has not yet been set.
     On April 28, 2009, Tang Capital and Perceptive brought suit against us in the Superior Court of the State of Washington, Thurston County (Tang Capital Partners, et al. v. Penwest Pharmaceuticals Co.),seeking either for the court to set the number of directors to be elected at the 2009 annual meeting of shareholders at three rather than two, or for the court to require us to waive the advance notice provisions of our bylaws to permit themTang Capital and Perceptive to include a proposal in the proxy statement in which the required percentage for board approval of certain matters would be 81% or more, rather than 75% or more. On May 13, 2009, Plaintiffs intend to seekdismissed this Thurston County action reasserting the same claims via an amended complaint in the King County action. Plaintiffs sought preliminary injunctive relief on their claims before the 2009 Annual Meeting of Shareholders and the motion was denied by the court. Tang Capital and Perceptive then filed a subsequent claim for a trial. Although this claim is still outstanding in King County, the proposed bylaw amendment and bylaw proposal was not passed by our shareholders at the annual meeting, of shareholdersthe trial is currently scheduled for June 10, 2009.October 4, 2010.
Item 1A.Risk Factors
     Investing in our common stock involves a high degree of risk, and you should carefully consider the risks and uncertainties described below in addition to the other information included or incorporated by reference in this quarterly report onForm 10-Q. If any of the following risks actually occurs, our business, financial condition or results of operations would likely suffer, possibly materially. In that case, the trading price of our common stock could fall.
We have a history of net losses and may not be able to achieve or maintain profitability on an annual basis
     We have incurred net losses since 1994, including net losses of $26.7 million, $34.5 million and $31.3 million during 2008, 2007 and 2006, respectively. For the threesix month period ended March 31,June 30, 2009, our net loss was $962,000.$3.1 million. As of March 31,June 30, 2009, our accumulated deficit was approximately $235$237 million.

38


     We anticipate that, based upon our current operating plan, which contemplates a significant reduction in our operating expenses, as compared to 2008 levels, and includes expected royalties from third parties, we will achieve quarterly profitability in the fourth quarter of 2009. If we do not receive royalties from Endo for Opana ER in such amounts as forecasted and provided to us by Endo, or if we are unable to significantly reduce our operating expenses, compared with 2008 levels, we may not be able to achieve quarterly profitability in the fourth quarter of 2009. However, even if we are able to achieve profitability on a quarterly basis, we may not be able to maintain it, or we may not be able to achieve profitability on an annual basis.
     Developing drug candidates to treat rare disorders of the nervous system will require us to incur substantial costs and expenses associated with preclinical and clinical trials, regulatory approvals and commercialization. For instance, if we determine to advance A0001 into later stage clinical trials in 2010, such costs and expenses are likely to increase. As a result, we may continue to incur net losses until such time as we can generate significant revenue from Opana ER or other products that we develop. Net losses have had and will continue to have an adverse effect on our shareholders’ equity, total assets and working capital.
     Our future profitability will depend on numerous factors, including:
the commercial success of Opana ER, and the amount of royalties from Endo’s sales of Opana ER, which may be adversely affected by any potential generic competition;

35


the commercial success of Opana ER, and the amount of royalties from Endo’s sales of Opana ER, which may be adversely affected by any potential generic competition;
  our ability to successfully defend our intellectual property protecting our products;
 
  our ability to access funding support for development programs from third party collaborators;
 
  the level of our investment in research and development activities, including the timing and costs of conducting clinical trials of our products;
 
  the level of our general and administrative expenses;
 
  the successful development and commercialization of product candidates in our portfolio and products being developed for collaborations; and
 
  royalties from Mylan’s sales of Pfizer’s generic version of Procardia XL 30 mg.
We may require additional funding, which may be difficult to obtain
     As of March 31,June 30, 2009, we had cash, cash equivalents and marketable securities of approximately $15.0$12.7 million. We anticipate that, based upon our current operating plan, our existing capital resources, together with expected royalties from third parties, will be sufficient to fund our operations on an ongoing basis through at least 2010. If we do not receive royalties from Endo for Opana ER in such amounts as we anticipate, we may not be able to fund our ongoing operations through 2010 without seeking additional funding from the capital markets.
     We have taken measures to reduce our spending and to manage our costs more closely, including staff reductions that we implemented in March 2008 and January 2009, and have established a narrowed set of priorities for 2009, which recognize our limited financial resources and the challenging environment in which we operate. We are incurringhave however, incurred significant unplanned costs in connection with an ongoingour shareholder proxy contest.contest and the related litigation. These costs are difficult to predict but, we currently estimate total expenses,incurred in connection with the proxy solicitation, including legal and other advisory fees, totaled $1.3 million in connection with the proxy solicitation to be $875,000, which includes currentsix month period ended June 30, 2009, and included costs of litigation relating to suitsthree lawsuits brought by the dissident shareholders.shareholders, one of which is still pending. The costs of litigation are difficult to project. As a result, our legal expenses could increase depending on the course of the litigation.
     We are also seeking to enter into collaboration and licensing agreements for the development and marketing of Opana ER in territories outside the United States and for nalbuphine ER, and to enter into additional drug delivery technology collaborations. These collaborations may provide additional funding for our operations.

39


     Requirements for capital in our business are substantial. Our potential need to seek additional funding will depend on many factors, including:
  the commercial success of Opana ER, and the amount of royalties from Endo’s and Valeant’s sales of Opana ER, which may be adversely affected by any potential generic competition;
 
  the prosecution, defense and enforcement of our patents and other intellectual property rights, such as our Orange Book listed patents for Opana ER, and the prosecution by us and Endo of additional patent applications with respect to Opana ER;
 
  the timing and amount of payments received under collaborative agreements including our agreement with Mylan with respect to Pfizer’s generic version of Procardia XL 30 mg;
 
  the timing and amount of our internal costs of development for drug candidates for which we acquire rights under the Edison agreement;
 
  the progress of our existing development projects and any development projects we may undertake, funding obligations with respect to the projects and the related costs to us of clinical studies for our product candidates;
 
  our ability to enter into collaborations for Opana ER outside the United States nalbuphine ER and our drug delivery technologies, and the structure and terms of any such agreements;

36


  our ability to access funding support for development programs from third party collaborators;
 
  the level of our investment in capital expenditures for facilities and equipment;
 
  the timing and amount of our costs in connection with our proxy contest and the shareholder lawsuits filed against us and our directors; and
 
  our success in reducing our spending and managing our costs.
     Under the current economic environment, market conditions have made it very difficult for companies like ours to obtain equity or debt financing. We believe that any such financing that we could obtain would be on significantly unfavorable terms. If we raise additional funds by issuing equity securities, further dilution to our then-existing shareholders may result. Additional debt financing, such as the credit facility noted above, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt or equity financing may contain terms, such as liquidation and other preferences, that are not favorable to us or our shareholders. If we raise additional funds through collaboration and licensing arrangements, or research and development arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, research programs or potential products, or grant licenses on terms that may not be favorable to us. If we seek but are unable to obtain additional financing, we may be required to delay, reduce the scope of, or eliminate our planned development activities, including our planned clinical trials, which could harm our financial condition and operating results.
Our ability to generate revenues depends heavily on the success of Opana ER
     We made a significant investment of our financial resources in the development of Opana ER. In the near term, our ability to generate significant revenues will depend primarily on the growth of Opana ER sales by Endo. Opana ER competes with a number of approved drugs manufactured and marketed by major pharmaceutical companies and generic versions of some of these drugs. It may have to compete against new drugs and generic versions of Opana ER that may enter the market in the future.
     The degree of market success of Opana ER depends on a number of factors, including:
the safety and efficacy of Opana ER as compared to competitive products;

40


the safety and efficacy of Opana ER as compared to competitive products;
  Endo’s ability to educate the medical community about the benefits, safety profile and efficacy of Opana ER;
 
  the effectiveness of Endo’s sales and marketing activities;
 
  Endo’s ability to manufacture and maintain suitable inventory for sale on an ongoing basis;
 
  the reimbursement policies of government and third party payors with respect to Opana ER;
 
  the pricing of Opana ER;
 
  the level of stocking of Opana ER by wholesalers and retail pharmacies;
the required risk evaluation management strategy currently being considered by FDA; and
 
  the availability of generic versions of Opana ER and the timing of generic competition.
     IMPAX, Actavis, Sandoz and SandozBarr have each filed an ANDA that, together with their respective amendments, cover all seven strengths of Opana ER. Barr has also filed an ANDA that covers the Opana ER 5 mg, 10 mg, 20 mg and 40 mg strengths. We and Endo have filed patent infringement lawsuits against each of IMPAX, Sandoz and Barr in connection with their respective ANDAs and have settled our litigation with Actavis. Descriptions of these lawsuits are included in “Part II. Item 1. — Legal Proceedings.”
     We and Endo intend to pursue all available legal and regulatory avenues defending Opana ER. The new dosage form exclusivity for Opana ER granted by the FDA in connection with its approval of Opana ER expires in June

37


2009. In addition, we believe that we are entitled to a 30-month stay against IMPAX’s ANDA, Actavis’ ANDA, Sandoz’s ANDA and Barr’s ANDA under the Hatch-Waxman Act. IMPAX has announced that it is seeking to reinstate an earlier filing date of its ANDA covering Opana ER 5 mg, 10 mg, 20 mg and 40 mg. If this occurs or if we and Endo are unsuccessful in our Hatch-Waxman patent lawsuits, Opana ER could be subject to generic competition earlier. We expect that competition from one or more of these generic companies could cause significant erosion to the pricing of Opana ER, which in turn would adversely affect the royalties that we receive from Endo and our results of operations and financial condition.
     If Opana ER sales do not grow steadily or substantially, it would have a material adverse effect on our business, financial condition and results of operations.
     In the event that we are able to obtain regulatory approval of any of our other products candidates, the success of those products would also depend upon their acceptance by physicians, patients, third party payors or the medical community in general. There can be no assurance as to market acceptance of our drug products or our drug delivery technologies.
Our success depends on our ability, or our collaborator’s ability, to protect our patents and other intellectual property rights.
     Our success depends in significant part on our ability,or our collaborator’s ability, to obtain patent protection for our products, both in the United States and in other countries, or on our collaborator’s ability to obtain patents with respect to products on which we are collaborating with them. Our success also depends on our and our collaborator’s ability to enforce these patents. Patent positions can be uncertain and may involve complex legal and factual questions. We and Endo have filed additional patent applications with respect to Opana ER which, if issued, could delay generic competition. However, patents may not be issued from these patent applications or any other patent applications that we own or license. If patents are issued, the claims allowed may not be as broad as we have anticipated and may not sufficiently cover our drug products or our technologies. In addition, issued patents that we own or license may be challenged, invalidated or circumvented and we may not be able to bring suit to enforce these patents.
     We have four issued U.S. patents listed in the Orange Book for Opana ER, the earliest of which patents expired in September 2008 and the other of which patents expire in 2013, 2013 and 2023, respectively. As the owner of the patents listed in the Orange Book for Opana ER, we have become a party to ongoing Hatch-Waxman patent

41


litigation. We and Endo filed patent infringement suits against IMPAX, Sandoz and Barr in connection with their respective ANDAs for Opana ER, and we settled our litigation with Actavis. We believe that we are entitled to the “30-month stay” available under the Hatch-Waxman Act against each of IMPAX, Sandoz and Barr because we initiated the suit within 45 days of our receipt of their respective notice letters. However, IMPAX has publicly disclosed that it is seeking to reinstate an earlier filing date of its ANDA covering Opana ER 5 mg, 10 mg, 20 mg and 40 mg. If IMPAX is successful, we will not be entitled to the 30-month stay against IMPAX in these four strengths. If we proceed with the Hatch-Waxman litigation, we may not prevail on defending our patents. Litigation is inherently unpredictable and unfavorable rulings do occur. An unfavorable ruling or loss of the 30-month stay could subject Opana ER to earlier generic competition. We expect that generic competition would adversely affect the pricing of Opana ER, the royalties that we receive from Endo and the results of our operations and financial condition.
     Our research, development and commercialization activities or any products in development may infringe or be claimed to infringe patents of competitors or other third parties. In such event, we may be ordered to pay such third partyparties lost profits or punitive damages. We may have to seek a license from a third party and pay license fees or royalties. Awards of patent damages can be substantial. Licenses may not be available at all or available on acceptable terms, or the licenses may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. If we or our collaborators are not able to obtain a license, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations.
     Our success also depends on our ability to maintain the confidentiality of our trade secrets. We seek to protect such information by entering into confidentiality agreements with employees, consultants, licensees and other companies. These agreements may be breached by such parties. We may not be able to obtain an adequate remedy to such a breach. In addition, our trade secrets may otherwise become publicly known or be independently developed by our competitors.

38


We are dependent on our collaborators to manufacture and commercialize our products
     We have historically collaborated with partners to facilitate the manufacture and commercialization of our products and product candidates. We continue to depend on our collaborators to manufacture, market and sell our products. In particular, we are dependent on Endo to manufacture, market and sell Opana ER in the United States and on Mylan to market and sell Pfizer’s generic version of Procardia XL 30 mg.
     We have limited experience in manufacturing, marketing and selling pharmaceutical products. Accordingly, if we cannot maintain our existing collaborations or establish new collaborations with respect to our products, we will have to establish our own capabilities or discontinue commercialization of the affected products. Developing our own capabilities may be expensive and time consuming and could delay the commercialization of the affected products. There can be no assurance that we will be successful in developing these capabilities.
     Our existing collaborations may be subject to termination on short notice under certain circumstances such as upon a bankruptcy event or if we breach the agreement. If any of our collaborations are terminated, we may be required to devote additional internal resources to the product, seek a new collaborator on short notice or abandon the product. The terms of any additional collaborations or other arrangements that we establish may not be favorable to us.
     We are also at risk that these collaborations or other arrangements may not be successful. Factors that may affect the success of our collaborations include:
  Our collaborators may be pursuing alternative technologies or developing alternative products, either on their own or in collaboration with others, that may be competitive to the product on which we are collaborating, which could affect our collaborator’s commitment to our collaboration.
 
  Our collaborators may reduce marketing or sales efforts, or discontinue marketing or sales of our products, which could reduce the revenues we receive on the products.

42


 Our collaborators may pursue higher priority programs or change the focus of their commercialization programs, which could affect the collaborator’s commitment to us. Pharmaceutical and biotechnology companies re-evaluate their priorities from time to time, including following mergers and consolidations, which have been common in recent years in these industries.
 
 Disputes may arise between us and our collaborators from time to time regarding contractual or other matters. In 2006, we were engaged in a dispute with Endo with regard to the sharing of marketing expenses during the period prior to when Opana ER reaches profitability, which we subsequently resolved. Any other such disputes with Endo or other collaborators could be time consuming and expensive, and could impact our anticipated rights under our agreements with those collaborators.
We have limited experience in developing, manufacturing, marketing and selling pharmaceutical products
     We have limited experience in developing, manufacturing, marketing and selling pharmaceutical products. In the past, we have relied on our collaborators to manufacture, market and sell our products. Under our collaboration with Edison, we are responsible for pharmaceutical and clinical development, seeking regulatory approvals, manufacturing, and marketing of the products. Accordingly, we will have to continue to develop our own capabilities in these areas, or seek a collaborator.
     If we cannot establish our own capabilities successfully and on a timely basis, we may not be able to develop or commercialize these drug candidates. Developing our own capabilities may be expensive and time consuming and could delay the commercialization of the products we are developing.

39


The Drug Enforcement Agency, or DEA, limits the availability of the active drug substances used in Opana ER. As a result, Endo’s procurement quota may not be sufficient to meet commercial demand
     Under the Controlled Substances Act of 1970, the DEA regulates chemical compounds as Schedule I, II, III, IV or V substances, with Schedule I substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. The active drug substance in Opana ER, oxymorphone hydrochloride, is listed by the DEA as a Schedule II substance. Consequently, the manufacture, shipment, storage, sale, prescribing, dispensing and use of Opana ER are subject to a higher degree of regulation. For example, all Schedule II drug prescriptions must be written and signed by a physician, physically presented to a pharmacist and may not be refilled without a new prescription.
     Furthermore, the DEA limits the availability of the active drug substance used in Opana ER. As a result, Endo’s procurement quota of the active drug substance may not be sufficient to meet commercial demands. Endo must apply to the DEA annually for procurement quota in order to obtain the substance. Any delay or refusal by the DEA in establishing the procurement quota could cause trade inventory disruptions, which could have a material adverse effect on our business, financial condition and results of operations.
Misuse and/or abuse of Opana ER, , which contains a narcotic ingredient, could subject us to additional regulations, including compliance with risk management programs, which may prove difficult or expensive for us to comply with, and we and Endo may face lawsuits
     Opana ER contains a narcotic ingredient. Misuse or abuse of drugs containing narcotic ingredients can lead to physical or other harm. In the past few years, for example, reported misuse and abuse of OxyContin, a product containing the narcotic oxycodone, resulted in the strengthening of warnings on its labeling. The sponsor of OxyContin also faced numerous lawsuits, including class action lawsuits, related to OxyContin misuse or abuse. Misuse or abuse of Opana ER could also lead to additional regulation of Opana ER and subject us and Endo to litigation.
We face significant competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do
     The pharmaceutical industry is highly competitive and is affected by new technologies, governmental regulations, healthcare legislation, availability of financing and other factors. Many of our competitors have:

43


  significantly greater financial, technical and human resources than we have and may be better equipped to develop, manufacture and commercialize drug products;
 
  more extensive experience than we have in conducting preclinical studies and clinical trials, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products;
 
  competing products that have already received regulatory approval or are in late-stage development; or
 
  collaborative arrangements in our target markets with leading companies and research institutions.
     We face competition based on the safety and effectiveness of our products, the timing and scope of regulatory approvals, the availability and cost of supply, marketing and sales capabilities, reimbursement coverage, pricing, patent position and other factors. Our competitors may develop or commercialize more effective, safer or more affordable products, or obtain more effective patent protection. Accordingly, our competitors may commercialize products more rapidly or effectively than we do, which would adversely affect our competitive position, the likelihood that our product will achieve initial market acceptance and our ability to generate meaningful revenues from our products. Even if our products achieve initial market acceptance, competitive products may render our products obsolete or noncompetitive. If our products are rendered obsolete, we may not be able to recover the expenses of developing and commercializing those products.
     Opana ER faces competition from products with the same indications. For instance, Opana ER competes in the moderate to severe long acting opioid market with products such as OxyContin and MS Contin, Duragesic patch,

40


Avinza and Kadian and the generic versions of some of these drugs. Opana ER may also be subject to competition from generic versions of the product, such as the generic versions being developed by IMPAX, Actavis, Sandoz and Barr. We are also aware of tamper resistant formulations of oxycodone and morphine that have been submitted to the FDA for review and approval, which, if approved, would compete with Opana ER.
     Products developed through our collaboration with Edison may compete against products being developed by numerous private and public companies for at least some of the indications we may pursue. Various companies and institutions are conducting studies in the area of inherited mitochondrial disease. At least two companies have announced that they are pursuing programs based upon mitochondrial disease pathways. Santhera Pharmaceuticals is currently conducting clinical trials of the coenzyme Q analog, idebenone for the diseases of Friedreich’s Ataxia, Duchenne’s muscular dystrophy, and Leber’s Hereditary Optic Neuropathy. Santhera recently received regulatory approval in Canada for idebenone to be sold as a treatment for Friedreich’s Ataxia under the brand name Catena®. GlaxoSmithKline plc., through its acquisition of Sirtris is planning to study Sirtris’ drug candidate resveratrol for MELAS. If these companies are able to receive regulatory approvals for their products before we do, it may negatively impact our ability to receive regulatory approvals for our products if these products have orphan drug exclusivity or to achieve market acceptance of our products. If their products are more effective, safer or more affordable, our products may not be competitive.
     Our drug delivery technologies and our efforts to enter into drug delivery technology collaborations, face competition from numerous public and private companies and their extended release technologies, including the oral osmotic pump (OROS) technology marketed by Johnson & Johnson, multiparticulate systems marketed by Elan Corporation plc, Biovail Corporation and KV Pharmaceutical Company, and traditional matrix systems marketed by SkyePharma plc.
If our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products such as A0001
     In order to obtain regulatory approvals for the commercial sale of our products, we or our collaborators will be required to complete clinical trials in humans to demonstrate the safety and efficacy of the products. However, we may not be able to commence or complete these clinical trials in any specified time period, either because the FDA or other regulatory agencies object or for other reasons. With respect to our approved products, including Opana ER, we have relied on our collaborators to conduct clinical trials and obtain regulatory approvals. We may develop the product candidates we obtain under our collaboration with Edison independently, including controlling the

44


clinical trials and regulatory submissions with the FDA. We have limited experience in conducting Phase II and Phase III clinical trials and to date have not obtained approval for the marketing of a drug product. In 2005, we submitted an NDA for a product we were developing, PW2101, but we received a non-approvable letter from the FDA and terminated the development program.
     Even if we complete a clinical trial of one of our potential products, the clinical trial may not prove that our product is safe or effective to the extent required by the FDA, the European Commission, or other regulatory agencies to approve the product. We or our collaborators may decide, or regulators may require us or our collaborators, to conduct additional clinical trials. For example, Endo received an approvable letter for Opana ER from the FDA in response to its NDA for Opana ER, which required Endo to conduct an additional clinical trial and which significantly delayed the approval of Opana ER. In addition, regulators may require post-marketing testing and surveillance to monitor the safety and efficacy of a product.
     Some of the drug candidates we may develop will be in the early stages of development. There will be limited information and understanding of the safety and efficacy of these drug candidates. There may not be any clinical data available. We will have to conduct preclinical testing and clinical studies to demonstrate the safety and efficacy of these drug candidates. The results from preclinical testing of a product that is under development may not be predictive of results that will be obtained in human clinical trials. In addition, the results of early human clinical trials may not be predictive of results that will be obtained in larger scale advanced stage clinical trials. Furthermore, we, our collaborators, and the Institutional Review Board or the FDA may suspend clinical trials at any time if the healthy subjects or patients participating in such trials are being exposed to unacceptable health risks or for other reasons. In the third quarter of 2008, we terminated the development of PW4153 after the results of a Phase I study did not meet our target profile.

41


     The rate of completion of clinical trials is dependent in part upon the rate of enrollment of patients. Patient accrual is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study and the existence of competitive clinical trials. Delays in planned patient enrollment may result in increased costs and program delays.
     If clinical trials do not show any potential product to be safe or efficacious, if we are required to conduct additional clinical trials or other testing of our products in development beyond those that we currently contemplate or if we are unable to successfully complete our clinical trials or other testing, we may:
  be delayed in obtaining marketing approval for our products;
 
  not be able to obtain marketing approval for our products; or
 
  not be able to obtain approval for indications that are as broad as intended.
     Our product development costs may also increase if we experience delays in testing or approvals. In addition, significant delays in clinical trials could allow our competitors to bring products to market before we do and impair our ability to commercialize our products.
     We have received orphan drug designation for A0001 from the FDA for the treatment of inherited mitochondrial respiratory chain diseases. We plan to file for orphan drug status for A0001 in the European Union. The FDA and the European Union regulatory authorities grant Orphan Drug designation to drugs intended to treat a rare disease or condition. In the United States, orphan drug designation is generally for drugs intended to treat a disease or condition that affects fewer than 200,000 or more than 200,000 individuals and for which there is no reasonable expectation that the cost of developing and making available in the United States a product for this type of disease or condition will be recovered from sales in the United States for the product. In the European Union, orphan drug designation is for drugs intended to treat diseases affecting fewer than five in 10,000 individuals.
     Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to orphan drug exclusivity. Orphan drug exclusivity means that another application to market the same drug for the same indication may not be approved for a period of up to 10 years in the European Union, and for a period of seven years in the United States, except in

45


limited circumstances set forth in the U.S. Federal Food, Drug and Cosmetic Act. Obtaining orphan drug designations and orphan drug exclusivity for our products for the treatment of inherited mitochondrial respiratory chain diseases may be critical to the success of these products. If our competitor receives marketing approval before we do for a drug that is considered the same as our drug candidate for the same indication we are pursuing, we will be prevented from receiving marketing approval for our drug candidate during the orphan drug exclusivity period of the competitor.
     Even if we obtain orphan drug exclusivity for any of our potential products, we may not be able to maintain it. If a competitor product, containing the same drug as our product and seeking approval for the same indication, is shown to be clinically superior to our product, any orphan drug exclusivity we have obtained will not block the approval of such competitor product. In addition, if a competitor develops a different drug for the same indication as our approved indication, our orphan drug exclusivity will not prevent the competitor drug from obtaining marketing approval.
     Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Obtaining orphan drug designation may not provide us with a material commercial advantage.
Even if we are able to obtain regulatory approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims
     Even if we receive regulatory approval for A0001 or any other product candidate that we develop, we will have tested them in only a small number of carefully selected patients during our clinical trials. If our applications for

42


marketing are approved and more patients from the general population begin to use our products, new risks and side effects associated with our products may be discovered. As a result, regulatory authorities may revoke their approvals. In addition, we may be required to conduct additional clinical trials, make changes in labeling of our products, reformulate our productproducts or make changes and obtain new approvals for our and our suppliers’ manufacturing facilities. We might have to withdraw or recall our products from the marketplace. We may also experience a significant drop in the potential sales of our product if and when regulatory approvals for such productproducts are obtained, experience harm to our reputation in the marketplace or become subject to lawsuits, including class actions. Any of these results could decrease or prevent any sales of our approved productproducts or substantially increase the costs and expenses of commercializing and marketing our product.products.
Our controlled release drug delivery technologies rely on the ability to control the release of the active drug substances, and our business would be harmed if it was determined that there were circumstances under which the active drug substances from one of our extended release products would be released rapidly into the blood stream
     Our controlled release products and product candidates rely on our ability to control the release of the active drug substance. Some of the active ingredients in our controlled release products, including Opana ER, contain levels of active drug substance that could be harmful, even fatal, if the full dose of active drug substance were to be released over a short period of time, which is referred to as dose-dumping.
     In 2005, Purdue Pharma voluntarily withdrew from the market its product Palladone® (hydromorphone hydrochloride extended release capsules), after acquiring new information that serious and potentially fatal adverse reactions can occur when the product is taken together with alcohol. The data, gathered from a study testing the potential effects of the drug with alcohol use, showed that when Palladone is taken with alcohol, the extended release mechanism can fail and may lead to dose-dumping. In anticipation of questions from the FDA with respect to the potential dose-dumping effect of Opana ER given the FDA’s experience with Palladone, Endo conducted bothin vitroand human testing of the effect of alcohol on Opana ER. In thein vitrotesting, Endo did not find any detectible effect of alcohol on the time release mechanism of the product. In the human testing in the presence of alcohol, there was evidence of an increase in blood levels. The FDA received this data before approving the NDA and required that the Opana ER labeling specifically warn against taking the drug with alcohol of any kind.

46


We are subject to extensive government regulation including the requirement of approval before our products may be marketed. Even if we obtain marketing approval, our products will be subject to ongoing regulatory review
     We, our collaborators, our products, and our product candidates are subject to extensive regulation by governmental authorities in the United States and other countries. Failure to comply with applicable requirements could result in warning letters, fines and other civil penalties, delays in approving or refusal to approve a product candidate, product recall or seizure, withdrawal of product approvals, interruption of manufacturing or clinical trials, operating restrictions, injunctions and criminal prosecution.
     Our products cannot be marketed in the United States without FDA approval. Obtaining FDA approval requires substantial time, effort and financial resources, and there can be no assurance that any approval will be granted on a timely basis, if at all. We have had only limited experience in preparing applications and obtaining regulatory approvals. If the FDA does not approve our product candidates or does not approve them in a timely fashion, our business and financial condition may be adversely affected. Furthermore, the terms of marketing approval of any application, including the labeling content, may be more restrictive than we desire and could affect the marketability of our products.
     Certain products containing our controlled release technologies require the submission of a full NDA. A full NDA must include complete reports of preclinical, clinical and other studies to prove adequately that the product is safe and effective. These studies may involve, among other things, full clinical testing, which requires the expenditure of substantial resources. The drug candidates we are developing in collaboration with Edison will also require submission of full NDAs. In certain other cases when we seek to develop a controlled release formulation of an FDA-approved drug with the same active drug substance, we may be able to rely on previous FDA determinations of safety and efficacy of the approved drug to support a section 505(b)(2) NDA. We can provide no

43


assurance, however, that the FDA will accept a submission of a section 505(b)(2) NDA for any particular product. Even if the FDA did accept such a submission, the FDA may not approve the application in a timely manner or at all. The FDA may also require us to perform additional studies to support the modifications of the reference listed drug.
     In addition, both before and after regulatory approval, we, our collaborators, our products, and our product candidates are subject to numerous FDA regulations, among other things, covering testing, manufacturing, quality control, cGMP, adverse event reporting, labeling, advertising, promotion, distribution and export of drug products. We and our collaborators are subject to surveillance and periodic inspection by the FDA to ascertain compliance with these regulations. The relevant law and regulations may also change in ways that could affect us, our collaborators, our products and our product candidates. Failure to comply with regulatory requirements could have a material adverse impact on our business.
We may become involved in patent litigation or other proceedings relating to our products or processes, which could result in liability for damages or termination of our development and commercialization programs
     The pharmaceutical industry has been characterized by significant litigation, interference and other proceedings regarding patents, patent applications and other intellectual property rights. The types of situations in which we may become parties to such litigation or proceedings include:
  We or our collaborators may initiate litigation or other proceedings against third parties to enforce our intellectual property rights.
 
  If our competitors file patent applications that claim technology also claimed by us, we or our collaborators may participate in interference or opposition proceedings to determine the priority of invention.
 
  If third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend our rights in such proceedings.

47


     An adverse outcome in any litigation or other proceeding could subject us to significant liabilities and/or require us to cease using the technology that is at issue or to license the technology from third parties. We may not be able to obtain any required licenses on commercially acceptable terms, or at all.
     The cost of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. We could incur significant costs in participating or assisting in the litigation. In the case of the generic litigation involving Opana ER, our collaborator Endo is bearing all litigation costs. However, on other products we develop, we may be required to incur these costs to defend our patents. Our competitors may have substantially greater resources to sustain the cost of such litigation and proceedings more effectively than we can. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.
We have only limited manufacturing capabilities and will be dependent on third party manufacturers
     We lack commercial scalecommercial-scale facilities to manufacture our TIMERx materials or other products we are developing. We currently rely on Draxis Specialty Pharmaceuticals Inc. for the bulk manufacture of our TIMERx materials under a manufacturing and supply agreement with an initial term that expires in November 2009. The agreement automatically renews for successive one-year periods, unless either party gives notice of its intent not to renew the agreement at least 180 days prior to the end of the then-current term. On May 7, 2009, we received notice from Draxis, our contract manufacturer of TIMERx material, that as a result of its decision to cease manufacturing of solid dosage form products in the facility in which TIMERx is currently manufactured, it will not renew the manufacturing agreement with us upon the expiration of the current term in November 2009. As a result, we intend to increase our current inventory levels of TIMERx material and will work with Endo on various alternatives, including the qualification of another manufacturer. We believe that there are a limited number of manufacturers that comply with cGMP regulations and are capable of manufacturing our TIMERx materials. Although we have qualified alternate suppliers with respect to the xanthan gum and locust bean gum used to manufacture our TIMERx materials, we currently do not have a second supplier of TIMERx

44


materials. If we are unable to obtain alternative contract manufacturing or obtain such manufacturing on commercially reasonable terms, we may not be able to comply with our supply obligations to Endo with respect to Opana ER and our business could be materially adversely affected.
We are not a party to any agreements with our third partythird-party manufacturers for A0001, except for purchase orders or similar arrangements. If we are unable to enter into longer-term manufacturing arrangements for A0001 on acceptable terms, particularly as it advances through clinical development and moves closer to regulatory approval, our business and the development and commercialization of A0001 could be materially adversely affected.
There     In addition, there can be no assurance that Draxis or any other third parties we rely on for supply of our TIMERx materials or other products will perform. Any failures by third party manufacturers may delay the development of products or the submission for regulatory approval, impair our or our collaborators’ ability to commercialize products as planned and deliver products on a timely basis, require us or our collaborators to cease distribution, or recall some or all batches of products or otherwise impair our competitive position, which could have a material adverse effect on our business, financial condition and results of operations.
     If our third party manufacturers fail to perform their obligations, we may be adversely affected in a number of ways, including:
  we or our collaborators may not be able to meet commercial demands for Opana ER or our other products;
 
  we may not be able to initiate or continue clinical trials for products that are under development; and
 
  we may be delayed in submitting applications for regulatory approvals of our products.
     We may not be able to successfully develop our own manufacturing capabilities. If we decide to develop our own manufacturing capabilities, we will need to recruit qualified personnel, and build or lease the requisite facilities

48


and equipment we currently do not have. Moreover, it may be very costly and time consuming to develop such capabilities.
     The manufacture of our products is subject to regulations by the FDA and similar agencies in foreign countries. Any delay in complying or failure to comply with such manufacturing regulations could materially adversely affect the marketing of our products and our business, financial condition and results of operations.

45


We are dependent upon a limited number of suppliers for the gums used in our TIMERx materials
     Our TIMERx drug delivery systems are based on a hydrophilic matrix combining a heterodispersed mixture primarily composed of two polysaccharides, xanthan gum and locust bean gum, in the presence of dextrose. These gums are also used in our Geminex, gastroretentive and SyncroDose drug delivery systems. We and Draxis purchase these gums from a primary supplier. We have qualified alternate suppliers with respect to such materials, but we can provide no assurance that interruptions in supplies will not occur in the future. Any interruption in these supplies could have a material adverse effect on our ability to manufacture bulk TIMERx materials for delivery to our collaborators.
If we or our collaborators fail to obtain an adequate level of reimbursement by governmental or third party payors for Opana ER or any other products we develop, we may not be able to successfully commercialize the affected product
     The availability of reimbursement by governmental and other third party payors affects the market for any pharmaceutical products, including Opana ER. These third party payors continually attempt to contain or reduce the costs of health care by challenging the prices charged for pharmaceutical products. In certain foreign countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
     In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system. Further proposals are likely. The final adoption of these proposals may affect our or our collaborators’ ability to set prices which provide an adequate return on our investment.
     We expect Endo to experience pricing pressure with respect to Opana ER. We may experience similar pressure for other products for which we obtain marketing approvals in the future due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals. Neither we nor our collaborators may be able to sell products profitably if access to managed care or government formularies is restricted or denied, or if reimbursement is unavailable or limited in scope or amount.
We will be exposed to product liability claims and may not be able to obtain adequate product liability insurance
     Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing, marketing and sale of pharmaceutical products. Product liability claims might be made by consumers, healthcare providers, other pharmaceutical companies, or third parties that sell our products. These claims may be made even with respect to those products that are manufactured in regulated facilities or that otherwise possess regulatory approval for commercial sale.
     We are currently covered by primary product liability insurance in the amounts of $15 million per occurrence and $15 million annually in the aggregate on a claims-made basis, and by excess product liability insurance in the amounts of $5 million per occurrence and $5 million annually in the aggregate. This coverage may not be adequate to cover all product liability claims. Product liability coverage is expensive. In the future, we may not be able to maintain or obtain such product liability insurance at a reasonable cost or in sufficient amounts to protect us against potential liability claims. Claims that are not covered by product liability insurance could have a material adverse effect on our business, financial condition and results of operations.
If we are unable to retain our key personnel and continue to attract additional professional staff, we may not be able to maintain or expand our business

49


     Because of the scientific nature of our business, our ability to develop products and compete with our current and future competitors will remain highly dependent upon our ability to attract and retain qualified scientific, technical, commercial and managerial personnel. The loss of key scientific, technical, commercial or managerial personnel or the failure to recruit additional key scientific, technical, commercial or managerial personnel could have a material adverse effect on our business. We do not have employment agreements with our key executives and we cannot guarantee that we will succeed in retaining all of our key personnel. There is intense competition for qualified

46


personnel in our industry, and there can be no assurance that we will be able to continue to attract and retain the qualified personnel necessary for the success of our business.
The market price of our common stock may be volatile
     The market price of our common stock, like the market prices for securities of other pharmaceutical, biopharmaceutical and biotechnology companies, has been volatile. For example, the high and low closing prices of our common stock were $4.03 per share and $0.37 per share, respectively, during the twelve months ended March 31,June 30, 2009. On MayAugust 5, 2009, the closing market price of our common stock was $1.89.$2.73. The market is currently experiencing, and from time to time experiences, significant price and volume fluctuations that are unrelated to the operating performance of particular companies. The market price of our common stock may also fluctuate as a result of our operating results, sales of Opana ER, future sales of our common stock, announcements of technological innovations, new therapeutic products or new generic products by us or our competitors, announcements regarding collaborative agreements, clinical trial results, government regulations, developments in patent or other proprietary rights, public concern as to the safety of drugs developed by us or others, changes in reimbursement policies, comments made by securities analysts and other general market conditions.
Specific provisions of our Shareholder Rights Plan, Articles of Incorporation and Bylaws and the laws of Washington State make a takeover of Penwest or a change in control or management of our Company more difficult
     We have adopted a shareholder rights plan, often referred to as a poison pill. The rights issued under the plan will cause substantial dilution to a person or group that attempts to acquire us on terms that are not approved by our board of directors, unless the board first determines to redeem the rights. Various provisions of our Articles of Incorporation, our Bylaws and Washington law may also have the effect of deterring hostile takeovers, or delaying or preventing changes in control or management of our company, including transactions in which our shareholders might otherwise receive a premium for their shares over then — current market prices. In addition, these provisions may limit the ability of shareholders to approve transactions that they may deem to be in their best interest. We may in the future adopt measures that may have the effect of deterring hostile takeovers, or delaying or preventing changes in control or management of our company.
Proxy contests pursued by dissident shareholders may be costly and disruptive to our business operations
     Campaigns by significant investors to effect changes at publicly traded companies have increased in recent years. Perceptive Life Sciences Master Fund Ltd., orRepresentatives of Perceptive and Tang Capital Partners, LP, or Tang Capital, which currently beneficially own approximately 42% of our outstanding common stock, in the aggregate, have notified us of their intentionwere elected to nominate and solicit proxies for their own nominees for election as directorsour board at theour 2009 annual meeting of shareholders, and to makefollowing a numberproxy contest initiated by them. As part of shareholder proposals at our annual meeting. They havethe proxy contest, they also brought three lawsuits against us and our directors, twoone of which areis still outstanding.pending.
     This proxy contest and related litigation has resulted in substantial expense to us and consumed significant attention of our management and board of directors. These costs are difficult to predict but, we currently estimatein total expenses, including legal and other advisory fees, in connection withwere approximately $1.3 million for the proxy solicitation to be $875,000,six months ended June 30, 2009, which includes current costs of litigation relating to suitslawsuits brought by the dissident shareholders. The costs of litigation are difficult to project. As a result, our legal expenses could increase depending on the course of the outstanding litigation.
     Moreover, because the dissident shareholders are seeking to change our strategic direction, this proxy contest could also disrupt our operations and our ability to achieve our strategic goals by creatingcould be disrupted due to the uncertainty created for our employees, and current and prospective suppliers, manufacturers and collaborators. In addition, ifcollaborators as a result of the election of the two nominees, Perceptive and Tang Capital, are able to obtain veto power over important business decisions asour board and the passage, at our 2009 annual meeting, of a resolution that they propose, such veto power could enablealso proposed, requesting that the Perceptiveboard take prompt and Tang Capital-nominated personnelthoughtful action to stalematewind down substantially all of our operations, which could have a material adverse effect on our business, financial condition and results of operations.

4750


Item 4.Submission of Matters to a Vote of Security Holders
The following proposals were submitted to shareholders at our Annual Meeting of Shareholders held on June 10, 2009:
Proposal One — The proposed election of two Class III Directors.
         
  For Withheld
   
Joseph Edelman  28,093,570   1,143,880 
Kevin C. Tang  23,466,412   62,037 
William James O’Shea  4,671,195   1,037,806 
Dr. Andrew D. Levin  0   0 
     The two nominees who receive the highest number of votes cast for election were elected directors. Joseph Edelman and Kevin C. Tang received the highest votes cast for election and were elected Class III directors to the Board of Directors and will serve until the Annual Meeting of Shareholders to be held in 2012 or until their successors are duly elected and qualified.
     The following directors did not stand for reelection as directors as their terms of office continue after the meeting: Dr. Christophe Bianchi, Paul E. Freiman, Jennifer L. Good, Dr. Peter F. Drake, Dr. David P. Meeker and Anne M. VanLent.
     Proposal Two — Ratification of the selection of Ernst & Young LLP as our independent registered public accounting firm for the current year.
           
For Against Abstain
 
 26,163,182   161,945   2,912,323 
     Proposal Two was approved as it received the affirmative vote of the holders of a majority of the shares of common stock present or represented and voting on the matter, as required by the bylaws of the Company.
     Proposal Three — Amendment of the 1997 Employee Stock Purchase Plan to increase the number of shares of common stock authorized for issuance under the plan to 428,000 shares.
           
For Against Abstain
 
 12,322,499   13,880,110   3,034,840 
     Proposal Three was not approved as it did not receive the affirmative vote of the holders of a majority of the shares of common stock present or represented and voting on the matter, as required by the bylaws of the Company.
     Proposal Four — Amendment to the bylaws of the Company to require that annual meetings be held every April 30, or the next business day.
           
For Against Abstain
 
 19,779,209   7,127,736   2,330,504 
     Proposal Four was not approved as it did not receive the affirmative vote of the holders of at least two-thirds of the Company’s outstanding shares of common stock entitled to vote on the matter, as required by the bylaws of the Company.
     Proposal Five — Amendment to the bylaws of the Company to require the approval of at least 75% of the directors in office for various specified actions.
           
For Against Abstain
 
 19,495,521   7,423,145   2,318,784 

51


     Proposal Five was not approved as it did not receive the affirmative vote of the holders of at least two-thirds of the Company’s outstanding shares of common stock entitled to vote on the matter, as required by the bylaws of the Company.
     Proposal Six — The proposed request that the Board of Directors of the Company take prompt and thoughtful action to wind down substantially all of the Company’s operations.
           
For Against Abstain
 
 18,640,311   8,275,790   2,321,349 
     Proposal Six was a non-binding proposal that was approved as it received the affirmative vote of the holders of a majority of the shares of common stock present or represented and voting on the matter, as required by the bylaws of the Company.
Item 6.Exhibits
     See exhibit index below for a list of the exhibits filed as part of this Quarterly Report on Form 10-Q, which exhibit index is incorporated herein by reference.

4852


SIGNATURE
     Pursuant to the requirements 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.
     
 PENWEST PHARMACEUTICALS CO.
 
 
Date: May 7,August 10, 2009 /s/ Jennifer L. Good   
 Jennifer L. Good  
 President and Chief Executive Officer  

4953


EXHIBIT INDEX
   
Exhibit  
Number Description
4.1Rights Agreement, dated as of March 11, 2009 between Penwest Pharmaceuticals Co. and Mellon Investor Services LLC. (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed March 11, 2009).
10.1 Third Amendment, signed March 31, 2009, to the Amended and Restated Strategic AllianceSettlement Agreement dated as of April 2, 2002, by and between Penwest Pharmaceuticals Co. and Endo Pharmaceuticals Inc.
10.2Severance and Settlement Agreement and Release dated January 30,May 5, 2009, by and between Edison Pharmaceuticals, Inc. and the Registrant and Benjamin L. Palleiko.Company.
   
31 Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act Rules 13a-14(a) or 15d-14(a), as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
   
32 Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act Rules 13a-14(b) or 15d-14(b) and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of Sarbanes-Oxley Act of 2002.

5054