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Penwest Pharmaceuticals Co.(fka PPCO) RSS Feed

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3
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Posts (Total)
39
Created
02/04/08
Type
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http://www.penw.com/

http://finance.yahoo.com/q/ks?s=PPCO

http://www.form4oracle.com/company?cik=0001047188&ticker=PPCO

Penwest Pharmaceuticals Co. develops pharmaceutical products based on drug delivery technologies with focus on products that address disorders of the nervous system. It offers Opana ER, an oral extended release opioid analgesic for patients with moderate to severe pain requiring continuous opioid treatment; Nifedipine XL, for the treatment of hypertension and angina; and Cystrin CR for the treatment of urge urinary incontinence. The company's product candidates in clinical development include Nalbuphine ER for the treatment of moderate chronic pain; and Torsemide ER for the treatment of chronic edema, a condition involving excess fluid accumulation resulting from congestive heart failure. It also develops product candidates for the treatment of pain, epilepsy, Parkinson's disease, and spasticity. Penwest Pharmaceuticals has a strategic alliance agreement with Endo Pharmaceuticals, Inc., and a technology licensing collaborative agreement with Mylan Pharmaceuticals, Inc. The company was founded in 1991 and is based Danbury, Connecticut.

 
 

PENWEST PHARMACEUTICALS CO.
 

 

 
                 
    December 31,  
    2009     2008  
    (In thousands, except share amounts)  
 
ASSETS
Current assets:
               
Cash and cash equivalents
  $ 11,246     $ 16,692  
Marketable securities
    240        
Trade accounts receivable
    6,226       4,894  
Inventories, net
    263       440  
Prepaid expenses and other current assets
    1,289       1,365  
                 
Total current assets
    19,264       23,391  
Fixed assets, net
    1,576       2,177  
Patents, net
    996       1,819  
Deferred charges
    1,740       2,244  
Other assets, net
    2,320       2,223  
                 
Total assets
  $ 25,896     $ 31,854  
                 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
               
Accounts payable
  $ 750     $ 745  
Accrued expenses
    2,178       1,695  
Accrued development costs
    275       385  
Loan payable — current portion
    4,112       5,483  
Deferred compensation — current portion
    294       291  
                 
Total current liabilities
    7,609       8,599  
Loan payable
          4,112  
Accrued financing fee
          360  
Deferred revenue
    889       473  
Deferred compensation
    2,376       2,384  
                 
Total liabilities
    10,874       15,928  
Commitments and Contingencies (see Notes 13 and 18) 
               
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 31,778,416 shares at December 31, 2009 and 31,697,250 shares at December 31, 2008
    32       32  
Additional paid-in capital
    249,982       249,262  
Accumulated deficit
    (235,127 )     (233,627 )
Accumulated other comprehensive income
    135       259  
                 
Total shareholders’ equity
    15,022       15,926  
                 
Total liabilities and shareholders’ equity
  $ 25,896     $ 31,854  
                 
 
 

 

 

 

 

 
PENWEST PHARMACEUTICALS CO.
 
 
                         
    Year Ended December 31,  
    2009     2008     2007  
    (In thousands, except per share data)  
 
Revenues:
                       
Royalties
  $ 20,792     $ 6,805     $ 2,553  
Product sales
    562       685       519  
Collaborative licensing and development revenue
    2,458       1,044       236  
                         
Total revenues
    23,812       8,534       3,308  
Operating expenses:
                       
Cost of revenues
    2,655       1,438       605  
Selling, general and administrative
    9,413       12,052       14,260  
Research and product development
    12,430       21,041       23,561  
                         
Total operating expenses
    24,498       34,531       38,426  
                         
Loss from operations
    (686 )     (25,997 )     (35,118 )
Investment income
    15       541       1,770  
Interest expense
    (829 )     (1,278 )     (1,117 )
                         
Loss before income tax expense
    (1,500 )     (26,734 )     (34,465 )
Income tax expense
                 
                         
Net loss
  $ (1,500 )   $ (26,734 )   $ (34,465 )
                         
Basic and diluted net loss per common share
  $ (0.05 )   $ (0.89 )   $ (1.48 )
                         
Weighted average shares of common stock outstanding — basic and diluted
    31,666       29,923       23,216  
                         
 
 
See accompanying notes


F-4

 


 

Table of Contents

 

 
PENWEST PHARMACEUTICALS CO.
 
 
                                                 
                            Accumulated
       
                Additional
          Other
       
    Common Stock     Paid-In
    Accumulated
    Comprehensive
       
    Shares     Amount     Capital     Deficit     Income (Loss)     Total  
    (In thousands)  
 
Balances, December 31, 2006
    23,133     $ 23     $ 217,427     $ (172,428 )   $ 99     $ 45,121  
Net loss
                      (34,465 )           (34,465 )
Decrease in unrealized loss on marketable securities
                            18       18  
Adjustment for funded status of post retirement plan
                            63       63  
                                                 
Comprehensive loss
                                  (34,384 )
Proceeds from stock option and Employee Stock Purchase Plan exercises
    113             1,135                   1,135  
Issuance of common stock pursuant to royalty termination agreements
    39             573                   573  
Stock compensation charges in connection with stock incentive plans
    141             3,792                   3,792  
                                                 
Balances, December 31, 2007
    23,426       23       222,927       (206,893 )     180       16,237  
Net loss
                      (26,734 )           (26,734 )
Decrease in unrealized gain on marketable securities
                            (7 )     (7 )
Adjustment for funded status of post retirement plan
                            86       86  
                                                 
Comprehensive loss
                                    (26,655 )
Proceeds from Employee Stock Purchase Plan exercises
    41             70                   70  
Stock compensation charges in connection with stock incentive plans
    89             3,125                   3,125  
Issuance of common stock pursuant to an equity financing, net
    8,141       9       23,140                   23,149  
                                                 
Balances, December 31, 2008
    31,697       32       249,262       (233,627 )     259       15,926  
Net loss
                      (1,500 )           (1,500 )
Adjustment for funded status of post retirement plan
                            (124 )     (124 )
                                                 
Comprehensive loss
                                  (1,624 )
Proceeds from Employee Stock Purchase Plan exercises
    37             65                   65  
Stock compensation charges in connection with stock incentive plans
    44             655                   655  
                                                 
Balances, December 31, 2009
    31,778     $ 32     $ 249,982     $ (235,127 )   $ 135     $ 15,022  
                                                 
 
 
See accompanying notes


F-5

 


 

Table of Contents

 

 
PENWEST PHARMACEUTICALS CO.
 
 
                         
    Year Ended December 31,  
    2009     2008     2007  
    (In thousands)  
 
Operating activities:
                       
Net loss
  $ (1,500 )   $ (26,734 )   $ (34,465 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
                       
Depreciation
    641       989       1,107  
Amortization of patents
    289       367       379  
Inventory reserves
          18       18  
Patent impairment losses
    339       702       584  
Loss on disposal of fixed assets
    17       209        
Note receivable reserve
          1,000        
Deferred revenue
    416       290       140  
Deferred compensation
    171       177       182  
Deferred royalty termination costs amortization (paid)
    274       101       (1,541 )
Share-based compensation
    655       3,125       3,792  
Changes in operating assets and liabilities:
                       
Trade accounts receivable
    (1,332 )     (4,113 )     (98 )
Inventories
    177       209       (483 )
Accounts payable, accrued expenses and other
    (73 )     (2,298 )     752  
                         
Net cash provided by (used in) operating activities
    74       (25,958 )     (29,633 )
Investing activities:
                       
Acquisitions of fixed assets, net
    (80 )     (112 )     (918 )
Proceeds from sale of fixed assets
    23       318        
Patent costs
    (34 )     (349 )     (319 )
Purchases of marketable securities
    (1,220 )     (7,859 )     (24,605 )
Proceeds from maturities of marketable securities
    980       15,157       41,950  
Reimbursements of patent costs by collaborator
    229              
Loan disbursed to collaborator
          (1,000 )      
                         
Net cash (used in) provided by investing activities
    (102 )     6,155       16,108  
Financing activities:
                       
Issuance of common stock, net
    65       23,220       1,135  
Proceeds from loan payable
                12,000  
Repayment of debt
    (5,483 )     (2,405 )      
Debt issuance costs
                (112 )
                         
Net cash (used in) provided by financing activities
    (5,418 )     20,815       13,023  
Net (decrease) increase in cash and cash equivalents
    (5,446 )     1,012       (502 )
Cash and cash equivalents at beginning of year
    16,692       15,680       16,182  
                         
Cash and cash equivalents at end of year
  $ 11,246     $ 16,692     $ 15,680  
                         
 
 
See accompanying notes


F-6

 


 

Table of Contents

 

 
PENWEST PHARMACEUTICALS CO.
 
 
   
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 α-tocopherolquinone, a coenzyme Q analog 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® ER is an extended release formulation of oxymorphone hydrochloride that we developed with Endo Pharmaceuticals Inc., (“Endo”), using the Company’s proprietary extended release 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 2009 and 2008, the Company recognized $19.3 million and $5.0 million, respectively, in royalties from Endo related to sales of Opana ER. In June 2009, Endo signed an agreement with Valeant Pharmaceuticals International, (“Valeant”), to develop and commercialize Opana ER in Canada, Australia and New Zealand. Opana ER is not approved for sale in any country other than the United States.
 
The Company is conducting two Phase IIa clinical trials of A0001. The Company initiated one trial in patients with Friedreich’s Ataxia (“FA”), a rare degenerative neuro-muscular disorder, and the second trial in patients with the A3243G mitochondrial DNA point mutation that is commonly associated with MELAS syndrome, a rare progressive neurodegenerative disorder. The goal of these trials is to determine if A0001 has a discernible impact in the treatment of patients with these disorders using various biochemical, functional and clinical measures. The Company expects data from both of these trials by the third quarter of 2010. In September 2009, the Company exercised its option under its agreement with Edison, (the “Edison Agreement”), to acquire the right to a second drug candidate from Edison. The Company has determined not to conduct any additional development work on this compound until after it reviews the results of the Phase IIa studies of A0001.
 
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 its collaborator using its proprietary extended release technology. If the Company successfully formulates the compound, it will transfer the formulation to its collaborator, who is then responsible for the completion of the clinical development, manufacturing, and ultimately, the commercialization of the product. The Company is party to four such drug delivery technology collaborations with Otsuka Pharmaceuticals Co., (“Otsuka”). The Company signed two of these collaborations with Otsuka in 2009.
 
   
2.   SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation
 
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
 
Cash and Cash Equivalents
 
All highly liquid investments with maturities of 90 days or less when purchased are considered cash equivalents.


 

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