10-Q 1 d10q.htm FORM 10-Q Form 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


FORM 10-Q

 


 

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

For the quarterly period ended June 30, 2007

OR

 

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

For the transition period from              to             .

Commission File Number: 000-50855

 


Auxilium Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware   23-3016883

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

40 Valley Stream Parkway, Malvern, PA 19355

(Address of principal executive offices) (Zip Code)

(484) 321-5900

(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 the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  ¨    Accelerated filer  x    Non-accelerated filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

As of August 3, 2007, the number of shares outstanding of the issuer’s common stock, $0.01 par value, was 39,997,352.

 



PART I FINANCIAL INFORMATION

   3

    Item 1.

 

Financial Statements

   3
 

Consolidated Balance Sheets

   3
 

Consolidated Statements of Operations

   4
 

Consolidated Statements of Cash Flows

   5
 

Consolidated Statement of Stockholders’ Equity

   6
 

Notes to Consolidated Financial Statements

   7

    Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   13

    Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

   19

    Item 4.

 

Controls and Procedures

   19

PART II OTHER INFORMATION

   20

    Item 1A.

 

Risk Factors

   20

    Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

   29

    Item 4

 

Submission of Matters to a Vote of Security Holders

   30

    Item 6.

 

Exhibits

   31

SIGNATURES

   32


PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements.

AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

     June 30,
2007
    December 31,
2006
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 82,246     $ 44,835  

Short-term investments

     5,000       9,909  

Accounts receivable, trade, net

     10,353       9,267  

Accounts receivable, other

     358       507  

Inventories

     3,260       2,807  

Prepaid expenses and other current assets

     2,547       2,187  
                

Total current assets

     103,764       69,512  

Property and equipment, net

     6,751       4,732  

Other assets

     2,472       2,515  
                

Total assets

   $ 112,987     $ 76,759  
                

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Notes payable, current portion

   $ 37     $ 61  

Accounts payable

     1,694       2,073  

Accrued expenses

     22,325       19,522  

Deferred revenue, current portion

     698       686  

Deferred rent, current portion

     384       351  
                

Total current liabilities

     25,138       22,693  
                

Notes payable, long-term portion

     —         5  
                

Deferred revenue, long-term portion

     9,924       10,294  
                

Deferred rent, long-term portion

     1,566       1,438  
                

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $0.01 par value per share, 5,000,000 shares authorized, no shares issued or outstanding

     —         —    

Common stock, $0.01 par value per share; authorized 120,000,000 shares; issued 39,950,683 and 35,677,008 shares at June 30, 2007 and December 31, 2006, respectively

     400       357  

Additional paid-in capital

     281,482       225,577  

Accumulated deficit

     (205,361 )     (183,463 )

Treasury stock at cost: 14,232 shares

     (127 )     (113 )

Accumulated other comprehensive income

     (35 )     (29 )
                

Total stockholders’ equity

     76,359       42,329  
                

Total liabilities and stockholders’ equity

   $ 112,987     $ 76,759  
                

See accompanying notes to consolidated financial statements.

 

3


AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2007     2006     2007     2006  

Net revenues

   $ 23,340     $ 16,471     $ 41,760     $ 31,365  
                                

Operating expenses:

        

Cost of goods sold

     5,872       4,386       10,950       8,237  

Research and development*

     9,711       8,859       18,422       17,227  

Selling, general and administrative*

     18,503       15,473       35,709       28,379  
                                

Total operating expenses

     34,086       28,718       65,081       53,843  
                                

Loss from operations

     (10,746 )     (12,247 )     (23,321 )     (22,478 )

Interest income (expense), net

     724       494       1,426       1,053  

Other income (expense), net

     —         7       (3 )     6  
                                

Net loss

   $ (10,022 )   $ (11,746 )   $ (21,898 )   $ (21,419 )
                                

Basic and diluted net loss per common share

   $ (0.27 )   $ (0.40 )   $ (0.60 )   $ (0.73 )
                                

Weighted average common shares outstanding

     36,724,292       29,244,903       36,253,591       29,227,610  
                                

*includes the following amounts of stock-based compensation expense:

        

Research and development

   $ 272     $ 71     $ 494     $ 123  

Selling, general and administrative

     1,187       558       2,146       896  

See accompanying notes to consolidated financial statements.

 

4


AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

     Six Months Ended June 30,  
     2007     2006  

Cash flows from operating activities:

    

Net loss

   $ (21,898 )   $ (21,419 )

Adjustments to reconcile net loss to net cash used in operating activities:

    

Stock-based compensation

     2,640       1,019  

Depreciation and amortization

     624       478  

Changes in operating assets and liabilities:

    

Accounts receivable, trade and other

     (937 )     (4,143 )

Inventories

     (453 )     2,523  

Prepaid expenses and other current assets

     (362 )     715  

Accounts payable and accrued expenses

     2,420       338  

Deferred revenue

     (357 )     (2,562 )

Deferred rent

     152       (73 )
                

Net cash used in operating activities

     (18,171 )     (23,124 )
                

Cash flows from investing activities:

    

Redemptions of short-term investments

     15,811       52,350  

Purchases of short-term investments

     (10,902 )     (42,900 )

Purchases of property and equipment

     (2,588 )     (806 )
                

Net cash provided by investing activities

     2,321       8,644  
                

Cash flows from financing activities:

    

Proceeds from common stock offering, net of transaction costs

     49,866       —    

Payments on debt financings

     (30 )     (231 )

Employee Stock Purchase Plan purchases

     272       239  

Proceeds from exercise of common stock options

     3,170       534  

Purchase of treasury shares

     (14 )     (39 )
                

Net cash provided by financing activities

     53,264       503  
                

Effect of exchange rate changes on cash

     (3 )     13  
                

Increase (decrease) in cash and cash equivalents

     37,411       (13,964 )

Cash and cash equivalents, beginning of period

     44,835       31,380  
                

Cash and cash equivalents, end of period

   $ 82,246     $ 17,416  
                

See accompanying notes to consolidated financial statements.

 

5


AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statement of Stockholders’ Equity

Six Months Ended June 30, 2007

(In thousands, except share amounts)

(Unaudited)

 

     Common stock     Additional
paid-in
capital
   Accumulated
deficit
    Treasury Stock     Accumulated
other
comprehensive
loss
 
   Shares     Amount          Shares     Cost    

Balance, January 1, 2007

   35,677,008     $ 357     $ 225,577    $ (183,463 )   (13,377 )   $ (113 )   $ (29 )

Public offering, net of transaction costs

   3,672,000       37       49,829      —       —         —         —    

Exercise of common stock options

   547,004       5       3,164      —       —         —         —    

Employee Stock Purchase Plan purchases

   39,721       0       272      —       —         —         —    

Issuance of restricted stock

   15,000       0       0      —       —         —         —    

Cancellation of restricted stock

   (50 )     (0 )     0      —       —         —         —    

Stock-based compensation

   —         —         2,640      —       —         —         —    

Treasury stock acquisition

   —         —         —        —       (855 )     (14 )     —    

Foreign currency translation adjustment

   —         —         —        —       —         —         (6 )

Net loss

   —         —         —        (21,898 )   —         —         —    
                                                   

Balance, June 30, 2007

   39,950,683     $ 400     $ 281,482    $ (205,361 )   (14,232 )   $ (127 )   $ (35 )
                                                   

See accompanying notes to consolidated financial statements.

 

6


AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2007

(Unaudited)

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

(a) Basis of Presentation

The accompanying unaudited consolidated financial statements include the accounts of Auxilium Pharmaceuticals, Inc. and its wholly owned subsidiaries (the Company), and have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) pertaining to Form 10-Q. Certain disclosures required for complete annual financial statements are not included herein. All significant intercompany accounts and transactions have been eliminated in consolidation. The information at June 30, 2007 and for the six month periods ended June 30, 2007 and 2006 is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of the Company’s management, are necessary to state fairly the financial information set forth herein. The December 31, 2006 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2006 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2006 included in the Company’s Annual Report on Form 10-K filed with the SEC.

(b) Net Loss Per Common Share

Net loss per common share is calculated in accordance with Statement of Financial Accounting Standards (SFAS) No. 128, Earnings Per Share. Under the provisions of SFAS No. 128, basic net loss per common share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period reduced, where applicable, for unvested outstanding restricted shares.

 

7


The following table sets forth the computation of basic and diluted net loss per common share (in thousands, except share and per share amounts):

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2007     2006     2007     2006  

Numerator:

        

Net loss

   $ (10,022 )   $ (11,746 )   $ (21,898 )   $ (21,419 )
                                

Denominator:

        

Weighted-average common shares outstanding

     36,968,299       29,319,587       36,492,976       29,305,659  

Weighted-average unvested restricted common shares subject to forfeiture

     (244,007 )     (74,684 )     (239,385 )     (78,049 )
                                

Shares used in calculating net loss per common share

     36,724,292       29,244,903       36,253,591       29,227,610  
                                

Basic and diluted net loss per common share

   $ (0.27 )   $ (0.40 )   $ (0.60 )   $ (0.73 )
                                

Diluted net loss per common share is computed giving effect to all potentially dilutive securities, including stock options and warrants. Diluted net loss per common share for all periods presented is the same as basic net loss per common share because the potential common stock is anti-dilutive.

(c) New Accounting Pronouncements

On January 1, 2007, the Company adopted Financial Accounting Standards Board Interpretation No. 48 (FIN 48), “Accounting for Uncertainty in Income Taxes”. This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The adoption of FIN 48 had no significant impact on the Company’s consolidated results of operation and financial position.

The Company and its subsidiaries file income tax returns in the United Kingdom, United States and various state and local tax jurisdictions in the United States. The Company has net operating loss and credit carry forwards that will be subject to examination beyond the year in which they are ultimately utilized. The Company believes any future potential adjustments of these carryforwards will be immaterial to its financial statements due to the valuation allowance which fully offset all of its tax assets.

The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of June 30, 2007, the Company believes that there are no significant uncertain tax positions, and no amounts have been recorded for interest and penalties. The Company does not anticipate any events that would require it to record a liability related to any uncertain income tax position in 2007 as prescribed by FIN 48.

 

8


2. INVENTORIES

Inventories consist of the following (in thousands):

 

     June 30,
2007
   December 31,
2006

Raw materials

   $ 1,710    $ 1,519

Work-in-process

     779      194

Finished goods

     771      1,094
             
   $ 3,260    $ 2,807
             

3. ACCRUED EXPENSES

Accrued expenses consist of the following (in thousands):

 

     June 30,
2007
   December 31,
2006

Payroll and related expenses

   $ 5,067    $ 4,971

Royalty expenses

     2,738      2,228

Research and development expenses

     2,950      3,646

Sales and marketing expenses

     1,487      1,392

Testim rebates, discounts and returns accrual

     6,991      5,743

Other expenses

     3,092      1,542
             
   $ 22,325    $ 19,522
             

4. EMPLOYEE STOCK BENEFIT PLANS

(a) Employee Stock Purchase Plan

Under the Company’s 2006 Employee Stock Purchase Plan, as approved by the stockholders of the Company, employees may purchase shares of the Company’s common stock at a 15% discount through payroll deductions. Employees may contribute up to 10% of their compensation to the 2006 Employee Stock Purchase Plan. The purchase price is 85% of the fair value per share of common stock on the date the purchase period begins or the date on which the purchase period ends, whichever is lower. The plan restricts the maximum number of shares that an employee may purchase to 15,000 shares during each semi-annual purchase period and to $25,000 worth of common stock during each year. There is a maximum of 300,000 shares issuable under the 2006 Employee Stock Purchase Plan. In January 2007, employees purchased 39,721 shares of common stock at a price of $6.8595 per share, representing 85% of the closing price of the common stock on July 3, 2006, the first day at the beginning of the purchase period on which the market was open.

(b) Stock Options and Stock Awards

Under the Company’s 2004 Equity Compensation Plan (the 2004 Plan), as approved by the stockholders of the Company, qualified and nonqualified stock options and stock awards may be granted to employees, non-employee directors and service providers. In June 2007, the stockholders authorized the increase of shares authorized for issuance under the 2004 Plan to 8,000,000 shares. The Compensation Committee of the Board of Directors (the Compensation Committee) administers the 2004 Plan and has delegated to each of the Company’s Chief Executive Officer and Chief Financial Officer the authority to grant stock options to newly hired employees below the Vice President level within specified parameters. To date, the Company has granted only nonqualified stock options and restricted stock awards under the 2004 Plan. Stock options are granted with an exercise price equal to 100% of the market value of the common stock on the date of grant, and generally have a ten year contractual term and vest no later than four

 

9


years from the date of grant (with some providing for automatic vesting upon a charge of control of the Company). The Company issues new shares of common stock upon exercise of stock options. At June 30, 2007, there were 2,652,738 shares available for future grants under the 2004 Plan.

(c) General Stock Option Information

During the six months ended June 30, 2007, the Company granted 993,740 standard non-qualified stock options and 85,000 performance-based non-qualified stock options to employees to purchase shares of the Company’s common stock pursuant to the 2004 Plan. The options expire ten years from date of grant and their exercise prices represent the closing price of the common stock of the Company on the respective dates that the options were granted. The standard non-qualified stock options vest ratably over four years at one year intervals from the grant date, assuming continued employment of the grantee. The performance-based options were awarded to certain officers and will accrue, subject to vesting, to the grantee upon the Compensation Committee’s determination that the Company resumed the phase III trials for XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500, for the treatment of Dupuytren’s contracture in the fourth quarter of 2007. Each performance-based option has an exercise price of $13.16 and vests 33-1/3% on the one year anniversary of the Compensation Committee’s determination that the performance metric has been satisfied with the balance vesting in two equal annual installments thereafter, assuming the continued employment of the grantee (with automatic vesting upon a change of control of the Company).

The following tables summarize stock option activity for the six month period ended June 30, 2007:

 

     Six Months Ended June 30, 2007

Stock options

   Shares     Weighted
average
exercise
price
   Weighted
average
remaining
contractual
life (in years)
  

Aggregate
intrinsic

value

Options outstanding:

          

Outstanding at December 31, 2006

   3,548,903     $ 7.40      

Granted

   1,078,740       13.73      

Exercised

   (547,004 )     5.80      

Canceled

   (111,526 )     8.45      
              

Outstanding at June 30, 2007

   3,969,113     $ 9.32    8.60    $ 26,317,000
                        

Exercisable at June 30, 2007

   1,217,091     $ 7.07    7.36    $ 10,797,000
                        

During the three and six month periods ended June 30, 2007, the weighted-average grant-date fair value of options granted was $8.34 and $7.56, the total intrinsic value of options exercised was $406,000 and $4,529,000, and the total fair value of options vested was $1,951,000 and $2,444,000, respectively.

The aggregate intrinsic values in the preceding table represent the total pre-tax intrinsic value, based on the Company’s stock closing price of $15.94 as of June 30, 2007, that would have been received by the option holders had all option holders exercised their options as of that date. All 1,217,091 exercisable options as of June 30, 2007 were in-the-money.

 

10


(d) Restricted Stock Information

The compensation cost of restricted stock awards is determined by their intrinsic value on the grant date. The following table summarizes the restricted stock activity for the six month period ended June 30, 2007:

 

Nonvested shares

   Shares     Weighted
average
grant-date
fair value

Nonvested at December 31, 2006

   232,544     $ 7.47

Granted

   15,000       13.39

Vested

   (8,742 )     5.94

Cancelled

   (50 )     7.50
        

Nonvested at June 30, 2007

   238,752     $ 7.90
            

(e) Valuation and Expense Information under SFAS No. 123R

The fair value of each share-based award was estimated on the date of grant using the Black-Scholes model and applying the assumptions in the following table. The expected volatility is based on the blended historical volatility of peer group companies and the historical volatility of the Company. The Company uses the simplified calculation of expected option life, described in Staff Accounting Bulletin No. 107, because the Company’s history is inadequate to determine a reasonable estimate of the option life. The dividend yield is determined based on the Company’s history to date and management’s estimate of dividends over the option life. The risk-free interest rate is based on the U.S. treasury yield curve in effect at the time of the grant.

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2007     2006     2007     2006  

Weighted average assumptions:

        

Expected life of options (in years)

   5.69     6.25     6.06     6.25  

Risk-free interest rate

   5.05 %   4.95 %   4.66 %   4.91 %

Expected volatility

   50.15 %   66.46 %   50.75 %   66.56 %

Expected dividend yield

   0.00 %   0.00 %   0.00 %   0.00 %

Pre-vesting forfeitures are estimated in the determination of total stock-based compensation cost based on Company experience. The estimate on pre-vesting forfeitures will be adjusted in future periods to the extent actual pre-vesting forfeitures differ, or are expected to differ, from such estimates. As of June 30, 2007, there was approximately $14,412,000 of total unrecognized stock-based compensation cost related to all share-based payments that will be recognized over the weighted-average period of 2.98 years. Future grants will add to this total, whereas future amortization over the vesting period of existing grants will reduce this total.

 

11


5. OTHER COMPREHENSIVE LOSS

Total comprehensive loss was as follows (in thousands):

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2007     2006     2007     2006  

Net loss

   $ (10,022 )   $ (11,746 )   $ (21,898 )   $ (21,419 )

Other comprehensive loss:

        

Foreign currency translation

     (1 )     8       (6 )     4  

Unrealized loss on available for sale securities

     —         (25 )     —         (41 )
                                

Comprehensive loss

   $ (10,023 )   $ (11,763 )   $ (21,904 )   $ (21,456 )
                                

The foreign currency translation amounts relate to the Company’s foreign subsidiary. The unrealized loss on available for sale securities relates to the Company’s short-term investments.

 

12


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the consolidated financial statements and the notes thereto appearing elsewhere in this report.

Special Note Regarding Forward-Looking Statements

Certain statements in this quarterly report are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements made with respect to our strategy, progress and timing of development programs and related trials, the efficacy of our product candidates, the commercial benefits available to us as a result of our agreements with third parties, future operations, financial position, future revenues, projected costs, the size of addressable markets, prospects, plans and objectives of management and other statements regarding matters that are not historical facts and involve predictions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “future,” “continue,” or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks and uncertainties including, among other things:

 

 

 

growth in sales of Testim®, our only marketed product;

 

   

growth of the overall androgen market;

 

   

the availability of and ability to obtain additional funds through public or private offerings of debt or equity securities;

 

   

achieving market acceptance of Testim by physicians and patients and competing effectively with other Testosterone Replacement Therapy (TRT) products;

 

   

obtaining and maintaining all necessary patents or licenses;

 

   

purchasing ingredients and supplies necessary to manufacture Testim at acceptable terms to us;

 

   

obtaining and maintaining third-party payor coverage and reimbursement for Testim and our product candidates;

 

   

the costs associated with acquiring and the ability to acquire additional product candidates or approved products;

 

   

the ability to resume clinical trials for XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500;

 

   

demonstrating the safety and efficacy of product candidates at each stage of development;

 

   

the size of addressable markets for our product candidates;

 

   

results of clinical trials;

 

   

meeting applicable regulatory standards, filing for and receiving required regulatory approvals;

 

   

complying with the terms of our license and other agreements;

 

   

the ability to manufacture or have manufactured Testim, XIAFLEX and other product candidates in commercial quantities at reasonable costs and compete successfully against other products and companies;

 

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changes in industry practice; and

 

   

one-time events.

These risks are not exhaustive. For a more detailed discussion of risks and uncertainties, see “Item 1A – Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 and “Item 1A – Risk Factors” of this quarterly report. Other sections of this quarterly report may include additional factors which could adversely impact the Company’s future results, performance, achievements and prospects. Moreover, the Company operates in a very competitive and rapidly changing environment. Given these risks and uncertainties, you should not place undue reliance on forward-looking statements. Although the Company believes that the expectations reflected in forward-looking statements are reasonable, it cannot guarantee that the future results, performance, achievements and prospects reflected therein will be achieved or occur. The Company qualifies all forward-looking statements by these cautionary statements.

Overview

We are a specialty biopharmaceutical company with a focus on developing and marketing products to urologists, endocrinologists, orthopedists and select primary care physicians. We currently have a sales and marketing organization of approximately 190 people. Our only marketed product, Testim®, is a proprietary, topical 1% testosterone once-a-day gel indicated for the treatment of hypogonadism. Hypogonadism is defined as reduced or absent secretion of testosterone which can lead to symptoms such as low energy, loss of libido, adverse changes in body composition, irritability and poor concentration.

Our current product pipeline includes:

Phase III:

- XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500, for the treatment of Dupuytren’s contracture

Phase II:

- XIAFLEX (clostridial collagenase for injection) for the treatment of Peyronie’s disease

- XIAFLEX (clostridial collagenase for injection) for the treatment of Frozen Shoulder syndrome (or Adhesive Capsulitis)

Phase I:

- AA4010, treatment for overactive bladder using our transmucosal film delivery system

Preclinical:

- two pain products using our transmucosal film delivery system, with rights to develop six other compounds for the treatment of pain.

In addition to the above, we have the rights to develop other hormone and urologic products using the transmucosal film technology and the option to license other indications for XIAFLEX other than dermal products for topical administration.

In December 2006, we suspended our phase III trials for XIAFLEX for the treatment of Dupuytren’s contracture because of a manufacturing issue, the formation of meltback in the product vials. As a result, the U.S. Food and Drug Administration (or FDA) placed these trials on clinical hold. We have conducted detailed investigations that have helped us to understand what we believe may have contributed to the issue and how we can minimize the risk that this issue will occur in the future. We have concluded that

 

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moisture in vials was the root cause of the manufacturing issue and have implemented corrective actions designed to reduce the moisture content in the vials. We continue to follow all of the batches manufactured earlier this year for stability. Multiple batches have reached the time frame where we saw melt-back in the December 2006 product, and the moisture levels remain at low levels and are consistent across all production batches. As a result, we believe that the product exhibits an appropriate, consistent stability profile over a reasonable time period. We further believe that we remain on track to re-initiate the phase III Dupuytren’s contracture clinical trials in the fourth quarter of 2007.

With regard to the development of XIAFLEX for the treatment of Peyronie’s disease for which we also received a clinical hold letter from the FDA, the FDA is requiring that we conduct animal studies in order to evaluate the impact of XIAFLEX on normal penile tissue, in case the injection misses the targeted plaque. In late 2006, we commenced several pilot studies designed to assist us in developing a definitive protocol for such animal studies. Based on current project plans, including communications with the FDA on their expectations for the animal studies, we expect to commence a phase IIb study in the first or second quarter of 2008. This phase IIb study will test dosing regimens and validate a patient-reported outcomes questionnaire that we have developed for Peyronie’s disease.

We have never been profitable and have incurred an accumulated deficit of $205.4 million as of June 30, 2007. We expect to incur significant operating losses for the foreseeable future. We anticipate that commercialization expenses, development costs, and in-licensing milestone payments related to existing and new product candidates and to enhance our core technologies will continue to increase in the near term. In particular, we expect to incur increased costs for:

 

   

selling and marketing as we continue to market Testim;

 

   

additional development and pre-commercialization costs for existing and new product opportunities;

 

   

acquisition costs for new product opportunities; and

 

   

increased general and administration expense to support the infrastructure required to grow and operate as a public company.

We will need to generate significant revenues to achieve profitability.

We expect that quarterly and annual results of operations will fluctuate for the foreseeable future due to several factors, for example:

 

   

the overall growth of the androgen market;

 

   

the timing and extent of research and development efforts;

 

   

milestone payments liability; and

 

   

the outcome and extent of clinical trial activities.

Our limited operating history makes accurate prediction of future operating results difficult.

Results of Operations

Accounting Changes

As discussed in Note 2(e) to the audited consolidated financial statements for the year ended December 31, 2006 included in the Company’s Annual Report on Form 10-K filed with the SEC, in the first quarter of 2006 the Company began recognizing revenue for Testim sales at the time of shipment of the product to customers. As a result of this change in revenue recognition, net revenues

 

15


for six months ended June 30, 2006 include a one-time benefit of $1.2 million and the net loss for the six months ended June 30, 2006 includes a one-time benefit of $0.7 million, or $0.02 per share.

Three Months Ended June 30, 2007 and 2006

Net revenues. Net revenues increased $6.9 million, or 42%, to $23.3 million for the quarter ended June 30, 2007 from $16.5 million for the comparable 2006 period. While we have inventory management agreements with our major customers that provide for inventory levels to be maintained within certain specified limits of product demand, decisions by our customers concerning the levels of inventory they maintain within these parameters can significantly influence our results for any particular reporting period. However, we estimate that the wholesaler inventory level remained fairly constant during the second quarter of 2007; whereas, for the second quarter of 2006, we estimate that Testim prescription activity was $1.6 million lower than revenues recognized on shipments to wholesalers.

The increase in net revenues for the second quarter of 2007 compared to the comparable 2006 period resulted primarily from substantial growth in Testim demand resulting from increased prescriptions and increases in pricing, net of discounts, rebates and coupons. According to National Prescription Audit (NPA) data from IMS Health (IMS), a pharmaceutical market research firm, Testim total prescriptions for the second quarter of 2007 grew 40% over the comparable period of 2006. We believe that Testim prescription growth in the 2007 period over the 2006 period was driven by physician and patient acceptance that Testim provides better patient outcomes, the shift in prescriptions away from the testosterone patch product and the other gel product to Testim, and the continued focus of our sales force on the promotion of Testim to urologists, endocrinologists and select primary care physicians. Net revenues for the second quarter of 2007 benefited from price increases having a cumulative impact of 11% over the comparable 2006 period, which was partially offset by increased utilization of coupons that are provided to new patients. Revenue from international licensing agreements, representing the amortization of upfront and milestone payments and related product shipments, in the second quarter of 2007 and 2006 amounted to $0.8 million and $0.4 million, respectively.

Cost of goods sold. Cost of goods sold was $5.9 million and $4.4 million for the three months ended June 30, 2007 and 2006, respectively. The increase in cost of goods sold for the three months ended June 30, 2007 over the comparable period in 2006 was principally attributable to the increase in Testim revenue in the U.S. Gross margin on our net revenues was 74.8% in the second quarter of 2007 compared to 73.4% in the comparable 2006 period. Gross margin reflects the cost of product sold as well as royalty payments made to the Company’s licensor on the sales of Testim. The improvement in gross margin reflects the impact of year-over-year price increases, partially offset by increases in coupon usage and low margin international product shipments.

Research and development expenses. Research and development costs for the second quarter of 2007 were $9.7 million compared with $8.9 million for the comparable year-ago period. The increase in research and development costs was primarily due to the increased spending for development and manufacturing scale up for XIAFLEX, largely offset by the reduction in spending that resulted from the discontinuance of TestoFilm™ development in October 2006.

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $18.5 million for the quarter ended June 30, 2007 compared with $15.5 million for the year-ago quarter. The increase was primarily due to higher investment in promotional spending for Testim, including the cost of increasing our sales force, pre-launch marketing for XIAFLEX, and higher stock-based compensation expense.

Interest income (expense), net. Interest income, net was $0.7 million and $0.5 million for the three months ended June 30, 2007 and 2006, respectively. Net interest income relates primarily to interest earned on cash, cash equivalents and short-term investments.

 

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Six Months Ended June 30, 2007 and 2006

Net revenues. Net revenues increased $10.4 million, or 33%, to $41.8 million for the six months ended June 30, 2007 from $31.4 million for the comparable 2006 period. Net revenues for 2006 included a one-time benefit of $1.2 million, resulting from the adoption of the wholesaler method of revenue recognition. Excluding this one-time increase in 2006 revenue, net revenues for the six months ended June 30, 2007 increased 38% over the comparable 2006 period. While we have inventory management agreements with our major customers that provide for inventory levels to be maintained within certain specified limits of product demand, decisions by our customers concerning the levels of inventory they maintain within these parameters can significantly influence our results for any particular reporting period. We estimate that for the first six months of 2007 Testim prescription activity was approximately $0.9 million higher than revenues recognized on shipments to wholesalers; whereas, for the first six months of 2006, we estimate that Testim prescription activity was $1.6 million lower than revenues recognized on shipments to wholesalers, excluding the impact of the change to the wholesaler method of revenue recognition.

The increase in net revenues for the first six months of 2007 compared to the comparable 2006 period resulted primarily from substantial growth in Testim demand resulting from increased prescriptions and increases in pricing, net of discounts, rebates and coupons. According to National Prescription Audit (NPA) data from IMS Health (IMS), a pharmaceutical market research firm, Testim total prescriptions for the first six months of 2007 grew 39.3% over the comparable period of 2006. We believe that Testim prescription growth in the 2007 period over the 2006 period was driven by physician and patient acceptance that Testim provides better patient outcomes, the shift in prescriptions away from the testosterone patch product and the other gel product to Testim, and the continued focus of our sales force on the promotion of Testim to urologists, endocrinologists and select primary care physicians. Net revenues for the first six months of 2007 benefited from price increases having a cumulative impact of 12% over the comparable 2006 period, which was partially offset by increased utilization of coupons that are provided to new patients. Revenue from international licensing agreements, representing the amortization of upfront and milestone payments and related product shipments, in the first six months of 2007 and 2006 amounted to $1.2 million and $0.5 million, respectively.

Cost of goods sold. Cost of goods sold was $10.9 million and $8.2 million for the six months ended June 30, 2007 and 2006, respectively. The increase in cost of goods sold for the six months ended June 30, 2007 over the comparable period in 2006 was principally attributable to the increase in Testim revenue in the U.S. Gross margin on our net revenues was 73.8% in the first six months of 2007 compared to 73.7% in the comparable 2006 period. Excluding the impact of the change to the wholesaler revenue recognition method, gross margin for the first six months of 2006 was 74.3%. Gross margin reflects the cost of product sold as well as royalty payments made to the Company’s licensor on the sales of Testim. The reduction in gross margin from the comparable 2006 level reflects the costs of Testim manufacturing and quality improvement programs initiated in the first quarter of 2007 and increases in low margin international product shipments and coupon usage, partially offset by the year-over-year price increases.

Research and development expenses. Research and development costs for the first six months of 2007 were $18.4 million compared with $17.2 million for the comparable year-ago period. The increase in research and development costs was primarily due to the increased spending for development and manufacturing scale up for XIAFLEX, largely offset by the reduction in spending that resulted from the discontinuance of TestoFilm™ development in October 2006.

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $35.7 million for the six months ended June 30, 2007 compared with $28.4 million for the comparable year-ago period. The increase was primarily due to higher investment in promotional spending for Testim, including the cost of increasing our sales force, pre-launch marketing for XIAFLEX, and higher stock-based compensation expense.

Interest income (expense), net. Interest income, net was $1.4 million and $1.1 million for the six months ended June 30, 2007 and 2006, respectively. Net interest income relates primarily to interest earned on cash, cash equivalents and short-term investments.

 

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Liquidity and Capital Resources

Since inception through June 30, 2007, we have financed our product development, operations and capital expenditures primarily from private and public sales of equity securities. Since inception through June 30, 2007, we received net proceeds of approximately $276.3 million from private and public sales of equity securities and the exercise of stock options. We had $87.2 million and $54.7 million in cash, cash equivalents and short-term investments as of June 30, 2007 and December 31, 2006, respectively.

We believe that our current financial resources and sources of liquidity will be adequate to fund our anticipated operations until at least 2009. We may, however, need to raise additional funds prior to this time because of a number of factors, including:

 

   

Testim market acceptance and sales growth;

 

   

our ability to realize sales efficiency and effectiveness of our sales force;

 

   

growth of the overall androgen market which may be influenced by Solvay’s sales and marketing efforts;

 

   

third-party payor coverage and reimbursement for Testim;

 

   

the cost of manufacturing, distributing, marketing and selling Testim;

 

   

the scope, rate of progress and cost of our product development activities;

 

   

future clinical trial results;

 

   

the terms and timing of any future collaborative, licensing, co-promotion and other arrangements that we may establish;

 

   

the cost and timing of regulatory approvals;

 

   

the costs of supplying and commercializing XIAFLEX and any of our product candidates;

 

   

increased administrative costs to support a growing infrastructure;

 

   

acquisition or in-licensing costs;

 

   

the effect of competing technological and market developments;

 

   

changes to the regulatory approval process for product candidates in those jurisdictions, including the U.S., in which we may be seeking approval for our product candidates;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and

 

   

the extent to which we acquire or invest in businesses and technologies.

Insufficient funds may cause us to delay, reduce the scope of, or eliminate one or more of our development, commercialization or expansion activities. If additional funds are required, we may raise such funds from time to time through public or private sales of equity or debt securities or from bank or other loans. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely impact our growth plans and our financial condition or results of operations. Additional equity financing, if available, may be dilutive to the holders of our common stock and may involve significant cash payment obligations and covenants that restrict our ability to operate our business.

Sources and Uses of Cash

Cash used in operations was $18.2 million and $23.1 million for the six months ended June 30, 2007 and 2006, respectively. In both periods, cash used in operations resulted primarily from operating losses.

 

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Cash provided by investing activities was $2.3 million for the six months ended June 30, 2007 compared to cash used of $8.6 million for the six months ended June 30, 2006. Cash provided by investing activities in the 2007 period and the 2006 period relates primarily to the net effect of purchases and redemptions of short-term investments, together with our investments in property and equipment.

Cash provided by financing activities was $53.3 million and $0.5 million for the six months ended June 30, 2007 and 2006, respectively. Cash provided by financing activities in the 2007 period results primarily from the $49.9 million in net proceeds we received in the June 2007 registered direct offering and the cash receipts from stock option exercises and employee stock purchases. Cash provided by financing activities for the 2006 period results primarily from cash receipts from stock option exercises, partially offset by debt payments on debt financings.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements as defined in Item 303(a) (4) of Regulation S-K.

New Accounting Pronouncements

See Note 1(c)—New Accounting Pronouncements to the Company’s Consolidated Financial Statements contained in this Report.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are subject to market risks in the normal course of our business, including changes in interest rates and exchange rates. There have been no significant changes in our exposure to market risks since December 31, 2006. Refer to “Item 7 A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the year ended December 31, 2006 for additional information.

 

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this Report were effective, in that they provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms.

Changes in Internal Control over Financial Reporting.

There was no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1A. Risk Factors.

In addition to the other information contained in this Report, you should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2006 in evaluating our business, financial position, future results, and prospects. The information presented below updates and supplements those risk factors for events, changes and developments since the filing of that Form 10-K and should be read in conjunction with the risks and other information contained in that Form 10-K. The risks described in our Form 10-K, as updated below, are not the only risks we face. Additional risks that we do not presently know or that we currently believe are immaterial could also materially adversely affect our business, financial position, future results and prospects.

Risks Related to Our Financial Results and Need for Additional Financing

If we are unable to meet our needs for additional funding in the future, we may be required to limit, scale back or cease our operations.

Our operations to date have generated substantial and increasing needs for cash. Our negative cash flows from operations are expected to continue for at least the foreseeable future. Our strategy contains elements that we will not be able to execute without outside funding. Specifically, we may need to raise additional capital to:

 

   

enhance or expand our sales and marketing efforts for Testim or other products we may co-promote, acquire, in-license or develop;

 

   

fund our product development, including clinical trials;

 

   

commercialize and supply any product candidates that receive regulatory approval; and

 

   

acquire or in-license approved products or product candidates or technologies for development.

We believe that our existing cash resources and interest on these funds will be sufficient to meet our anticipated operating requirements until at least 2009. Our future funding requirements will depend on many factors, including:

 

   

Testim market acceptance and sales growth;

 

   

our ability to realize sales efficiency and effectiveness of our sales force;

 

   

growth of the overall androgen market which may be influenced by Solvay’s sales and marketing efforts;

 

   

third-party payor coverage and reimbursement for Testim;

 

   

the cost of manufacturing, distributing, marketing and selling Testim;

 

20


   

the scope, rate of progress and cost of our product development activities;

 

   

future clinical trial results;

 

   

the terms and timing of any future collaborative, licensing, co-promotion and other arrangements that we may establish;

 

   

the cost and timing of regulatory approvals;

 

   

the costs of supplying and commercializing XIAFLEX™ (clostridial collagenase for injection), formerly referred to as AA4500, and any of our product candidates;

 

   

increased administrative costs to support a growing infrastructure;

 

   

acquisition or in-licensing costs;

 

   

the effect of competing technological and market developments;

 

   

changes to the regulatory approval process for product candidates in those jurisdictions, including the U.S., in which we may be seeking approval for our product candidates;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and

 

   

the extent to which we acquire or invest in businesses, products and technologies.

These factors could result in variations from our currently projected operating and liquidity requirements. If our existing resources are insufficient to satisfy our liquidity requirements, we may need to borrow money or sell additional equity or debt securities. We may not be able to borrow money on commercially reasonable terms. Moreover, the terms of the sale of any equity or debt securities may not be acceptable to us and could result in substantial dilution of your investment. If we are unable to obtain this additional financing, we may be required to:

 

   

reduce the size or scope, or both, of our sales and marketing efforts for Testim or any of our future products;

 

   

delay or reduce the scope of, or eliminate one or more of our planned development, commercialization or expansion activities;

 

   

seek collaborators for our product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and/or

 

   

relinquish, license or otherwise dispose of rights to technologies, product candidates or products that we currently market or would otherwise seek to develop or commercialize ourselves on terms that are less favorable than might otherwise be available.

 

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Risks Related to Development of Our Product Candidates

We may not be able to develop product candidates into viable commercial products, which would impair our ability to grow and could cause a decline in the price of our stock.

The process of developing product candidates involves a high degree of risk and may take several years. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

 

   

clinical trials may show our product candidates to be ineffective or not as effective as anticipated or to have harmful side effects or any unforeseen result;

 

   

our inability to obtain FDA authorization to resume clinical trials of XIAFLEX within the expected timeframes;

 

   

product candidates may fail to receive regulatory approvals required to bring the products to market;

 

   

manufacturing costs and delays and manufacturing problems in general, the inability to scale up to produce supplies for clinical trials or commercial supplies, or other factors may make our product candidates uneconomical;

 

   

the proprietary rights of others and their competing products and technologies may prevent our product candidates from being effectively commercialized or to obtain exclusivity; and

 

   

failure to meet one or more of management’s target product profile criteria.

Success in preclinical and early clinical trials does not ensure that large-scale clinical trials will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly and may be difficult to predict. Currently, there is substantial congressional and administration review of the regulatory approval process for drug candidates in the U.S. Any changes to the U.S. regulatory approval process could significantly increase the timing or cost of regulatory approval for our product candidates making further development uneconomical or impossible.

In addition, developing product candidates is very expensive and will have a significant impact on our ability to generate profits. Factors affecting our product development expenses include:

 

   

changes to the regulatory approval process for product candidates in those jurisdictions, including the U.S., in which we may be seeking approval for our product candidates;

 

   

the cost and timing of manufacturing clinical or commercial supplies of product candidates, including the cost and timing of the implementation of any necessary corrective actions;

 

   

our ability to raise any additional funds that we need to complete our trials;

 

   

the number and outcome of clinical trials conducted by us and/or our collaborators;

 

   

the number of products we may have in clinical development;

 

   

in-licensing or other partnership activities, including the timing and amount of related development funding, license fees or milestone payments; and

 

   

future levels of our revenue.

Our product development efforts also could result in large and immediate write-offs, significant milestone payments, incurrence of debt and contingent liabilities or amortization of expenses related to intangible assets, any of which could negatively impact our financial results. Additionally, if we are unable to develop our product candidates into viable commercial products, we may

 

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remain reliant solely on Testim sales for our revenues, potentially limiting our growth opportunities. In October 2006, we decided to discontinue the development of the current formulation of TestoFilm™, our testosterone replacement transmucosal film product candidate for the treatment of hypogonadism and reallocate resources to our lead development project, XIAFLEX. Based on an evaluation, we determined that the current formulation of TestoFilm did not meet certain critical aspects of the target product profile and, as a result, would not be commercially viable.

If clinical trials for our product candidates are delayed, we would be unable to commercialize our product candidates on a timely basis, which could materially harm our business.

Clinical trials that we may conduct may not begin on time or may need to be restructured or temporarily suspended after they have begun. Clinical trials can be delayed or may need to be restructured for a variety of reasons, including delays or restructuring related to:

 

   

changes to the regulatory approval process for product candidates in those jurisdictions, including the U.S., in which we may be seeking approval for our product candidates;

 

   

obtaining an investigational new drug exemption, or IND, or other regulatory approval to commence a clinical trial;

 

   

timing of responses required from regulatory authorities;

 

   

negotiating acceptable clinical trial agreement terms with prospective investigators or trial sites;

 

   

obtaining institutional review board, or equivalent, approval to conduct a clinical trial at a prospective site;

 

   

recruiting subjects to participate in a clinical trial;

 

   

competition in recruiting clinical investigators;

 

   

shortage or lack of availability of clinical trial supplies from external and internal sources;

 

   

the need to repeat clinical trials as a result of inconclusive results or poorly executed testing;

 

   

the placement of a clinical hold on a study;

 

   

the failure of third parties conducting and overseeing the operations of our clinical trials to perform their contractual or regulatory obligations in a timely fashion;

 

   

exposure of clinical trial subjects to unexpected and unacceptable health risks or noncompliance with regulatory requirements, which may result in suspension of the trial; and

 

   

manufacturing issues associated with clinical supplies.

Prior to commencing clinical trials in the U.S., we must have an effective IND for each of our product candidates. An IND has been filed and is effective for XIAFLEX for the treatment of Dupuytren’s contracture, XIAFLEX for the treatment of Peyronie’s disease, and XIAFLEX for the treatment of Frozen Shoulder syndrome; however, INDs have not been filed for AA4010 or our pain transmucosal film product candidates. We will not be able to commence clinical trials in the U.S. for these product candidates until we file, and the FDA fails to object to, an IND for each candidate.

We have four projects in clinical development, specifically XIAFLEX for the treatment of Dupuytren’s contracture, Peyronie’s disease and Frozen Shoulder syndrome, and AA4010. Completion of clinical trials for each product candidate will be required before commercialization. In December 2006, we suspended the dosing of patients in our ongoing phase III trials for XIAFLEX for the treatment of Dupuytren’s contracture because of an issue related to the manufacture of clinical supplies of XIAFLEX and, as a result, the FDA placed these trials on clinical hold. With regard to the development of

 

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XIAFLEX for the treatment of Peyronie’s disease, for which we also received a clinical hold letter from FDA, the FDA is requiring that certain additional pre-clinical studies be completed prior to the initiation of the phase IIb dose ranging study or any other human study for Peyronie’s disease. If we are unable to obtain FDA authorization to resume clinical trials in a timely manner, or at all, or if we experience delays in, or termination of, clinical trials, or fail to resume clinical trials in a timely manner or if the cost or timing of the regulatory approval process increases, our financial results and the commercial prospects for our product candidates will be adversely impacted. In addition, our product development costs would increase and our ability to generate additional revenue from new products could be impaired.

Risks Related to Regulatory Approval of Our Product Candidates

Our controls over external financial reporting may fail or be circumvented.

We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we are required under SOA to report annually on our internal control over financial reporting. If we, or our independent registered public accounting firm, determine that our internal control over financial reporting is not effective, this shortcoming could have an adverse effect on our business and financial results and the price of our common stock could be negatively affected. This reporting requirement could also make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. Any failure or circumvention of the controls and procedures or failure to comply with regulation concerning control and procedures could have a material effect on our business, results of operation and financial condition. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees and as executive officers.

Risks Related to the Manufacture of XIAFLEX

Our Horsham facility is subject to regulatory oversight, which may delay or disrupt our development and commercialization efforts for XIAFLEX.

We must ensure that all of the processes, methods, equipment and facilities employed in the manufacture of XIAFLEX at our Horsham facility are compliant with the current Good Manufacturing Practices (cGMP). The cGMP requirements govern quality control of the manufacturing process and documentation policies and procedures. Compliance with cGMP requires record keeping and quality control to assure that the clinical and commercial product meets applicable specifications and other requirements. Our Horsham facility will be subject to inspection by regulatory agencies upon the manufacture of XIAFLEX that is used in a clinical trial or the filing for approval of XIAFLEX with regulatory authorities. If an inspection by regulatory authorities indicates that there are deficiencies including non-compliance with regulatory requirements, we could be required to take remedial actions, stop production or close our Horsham facility, which would disrupt the manufacturing processes, limit the supplies of XIAFLEX and delay clinical trials and subsequent licensure. If we fail to comply with these requirements, we may not be permitted to sell our products or may be limited in the jurisdictions in which we are permitted to sell them.

 

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Following licensure of our Horsham facility, noncompliance with any applicable regulatory requirements may result in refusal by regulatory authorities to allow use of XIAFLEX made at our Horsham facility in clinical trials, refusal of the government to allow distribution of XIAFLEX for commercialization, criminal prosecution and fines, recall or seizure of products, total or partial suspension of production, prohibitions or limitations on the commercial sale of products or refusal to allow the entering into of federal and state supply contracts.

Risks Related to Our Dependence on Third-Party Manufacturers and Service Providers

Since we currently rely on third-party manufacturers and suppliers, we may be unable to control the availability or cost of manufacturing our products, which could adversely affect our results of operations.

We currently do not manufacture Testim or any of our product candidates, except for the active ingredient for XIAFLEX. Testim is manufactured for us by DPT Laboratories, Ltd., or DPT, under a contract that expires on December 31, 2010. We have qualified a back-up supplier to manufacture Testim.

Although we manufacture the active ingredient for XIAFLEX, we have contracted with Cobra Biologics Ltd., or Cobra, for the production of our clinical supply of XIAFLEX, our product candidate for the treatment of Dupuytren’s contracture, Peyronie’s disease and Frozen Shoulder syndrome.

The manufacture of pharmaceutical products requires significant expertise and capital investment. DPT, Cobra, our back-up supplier for Testim, or any other third-party manufacturer may encounter difficulties in production. These problems may include:

 

   

difficulties with production costs and yields;

 

   

availability of raw materials and supplies;

 

   

quality control and assurance;

 

   

shortages of qualified personnel;

 

   

compliance with strictly enforced federal, state and foreign regulations; and

 

   

lack of capital funding.

DPT, PharmaForm, Cobra, or any of our other third-party manufacturers may not perform as agreed or may terminate its agreement with us, which would adversely impact our ability to produce and sell Testim or our ability to produce XIAFLEX or other product candidates for clinical trials. The number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture bulk drug substance on a commercial scale is limited, and it would take a significant amount of time to arrange and receive regulatory approval for alternative arrangements. We may not be able to contract for the manufacturing of Testim or any of our product candidates on acceptable terms, if at all, which would materially impair our business.

In December 2006, we suspended the dosing of our ongoing phase III trials for XIAFLEX for the treatment of Dupuytren’s contracture in response to an issue related to the manufacture of clinical supplies. While we believe that we have taken all

 

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appropriate remedial measures to address this issue, we cannot assure you that the issue will be remedied, or that we will not encounter similar or other issues related to the manufacture of our products and product candidates.

Any of these factors could increase our costs and result in us being unable to effectively commercialize or develop our products. Furthermore, if DPT, our back-up supplier for Testim or any other third-party manufacturer fails to deliver the required commercial quantities of finished product on a timely basis and at commercially reasonable prices, we may be unable to meet the demand for our products and we may lose potential revenues.

Risks Related to Intellectual Property

We have only limited patent protection for Testim and our product candidates, and we may not be able to obtain, maintain and protect proprietary rights necessary for the development and commercialization of Testim or our product candidates.

Our business and competitive positions are dependent upon our ability to obtain and protect our proprietary position for Testim and our product candidates in the U.S., Europe and elsewhere. Because of the substantial length of time and expense associated with development of new products, we, along with the rest of the biopharmaceutical industry, place considerable importance on obtaining and maintaining patent protection for new technologies, products and processes. The patent positions of pharmaceutical, biopharmaceutical and biotechnology companies, including ours, are generally uncertain and involve complex legal and factual questions. Our and our licensors’ patents and patent applications may not protect our technologies and products because, among other things:

 

   

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

 

   

we may develop additional proprietary technologies that are not patentable;

 

   

there is no guarantee that any patents issued to us, our collaborators or our licensors will provide us with any competitive advantage or cover our product candidates;

 

   

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

 

   

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

We attempt to protect our intellectual property position by filing or obtaining licenses to patent applications and, where appropriate, patent applications in other countries related to our proprietary technology, inventions and improvements that are important to the development of our business. Our PharmaForm transmucosal film product candidates are covered by a formulation patent in the U.S. only. This patent expires in 2020. Testosterone, the active ingredient in Testim, is off-patent and is included in competing TRT products. The U.S. patent that we license from Bentley covers the composition of matter and formulation of Testim and expires in June 2008. The European and Japanese patents that we license from Bentley for Testim expired in November 2006. The Canadian patents that we license from Bentley expire in January 2010. In July 2005, an additional patent covering Testim issued in Canada, and this patent is included in our license from Bentley. This patent expires in 2023. Bentley has filed a new patent application in the U.S., Europe and Japan which, if issued, could provide additional patent protection for Testim. Even if this new patent application issues in the U.S. and covers Testim, there is no guarantee that it will issue before the current Bentley U.S. patent expires in June 2008, thereby creating a gap in patent protection for Testim in the U.S. If a generic version of Testim is launched in the U.S. during such a gap in patent protection, we may not be able to halt sales of such generic after the new patent application issues and during the pendency of a patent infringement suit against generics, if ever.

 

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XIAFLEX licensed from BioSpecifics is covered by two method of use patents in the U.S., one for the treatment of Dupuytren’s contracture and one for the treatment of Peyronie’s disease. The Dupuytren’s patent expires in 2014, and the Peyronie’s patent expires in 2019. The patents are limited to the use of XIAFLEX for the treatment of Dupuytren’s contracture and Peyronie’s disease, respectively, with certain dose ranges and/or concentration ranges. The patent relating to Dupuytren’s contracture has been the subject of a reissue application in the USPTO for, among other things, the purpose of submitting prior art that was not previously submitted during the prosecution of the Dupuytren’s patent. The USPTO issued a Notice of Allowance for this patent in May 2007. In January 2005, a patent application was filed with regard to XIAFLEX for the treatment of Frozen Shoulder syndrome. If this patent is granted, it would expire in 2026. Currently there is not enough data to establish whether any approved product for Dupuytren’s contracture or Peyronie’s disease or Frozen Shoulder syndrome will be covered by these patents. In January 2006, we filed a patent application with regard to the manufacturing process for XIAFLEX; if this patent is granted, it would expire in January 2027.

Foreign patents and pending applications may also cover these products in certain countries depending upon the concentration and dosage ranges of such products. Some countries will not grant patents on patent applications that are filed after the public sale or disclosure of the material claimed in the patent application. The U.S., by contrast, allows a one year grace period after public disclosure in which to file a patent application. Because the European patent application was filed after Testim went on the market in the U.S., our ability to obtain additional patent protection outside of the U.S. may be limited.

The standards that the USPTO and its foreign counterparts use to grant patents are not always applied predictably or uniformly and can change. Limitations on patent protection in some countries outside the U.S., and the differences in what constitutes patentable subject matter in these countries, may limit the protection we seek outside of the U.S. For example, methods of treating humans are not patentable subject matter in many countries outside of the U.S. In addition, laws of foreign countries may not protect our intellectual property to the same extent as would laws of the U.S. In determining whether or not to seek a patent or to license any patent in a particular foreign country, we weigh the relevant costs and benefits, and consider, among other things, the market potential of our product candidates in the jurisdiction, and the scope and enforceability of patent protection afforded by the law of the jurisdiction. Failure to obtain adequate patent protection for our proprietary product candidates and technology would impair our ability to be commercially competitive in these markets. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims allowed in any patents issued to us or others.

We intend to seek patent protection whenever it is available for any products or product candidates we acquire in the future. However, any patent applications for future products may not issue as patents, and any patent issued on such products may be challenged, invalidated, held unenforceable or circumvented. Furthermore, the claims in patents which have been issued on products we may acquire in the future may not be sufficiently broad to prevent third parties from commercializing competing products. If we fail to obtain adequate patent protection for our products, our ability to compete could be impaired.

Technology in-licensed by us is important to our business. We may not control the patent prosecution, maintenance or enforcement of our in-licensed technology. Accordingly, we may be unable to exercise the same degree of control over this intellectual property as we would over our internally developed intellectual property. For example, in-licensed patents for which our rights are limited to a particular field of use could be or become licensed in other fields to other licensees and, therefore,

 

27


become subject to enforcement by such other licensees without our participation. Consequently, such licensed patents could be held invalid or unenforceable or could have claims construed in a manner adverse to our interests in litigation, which we would not control or to which we would not be a party. If any of the intellectual property rights of our licensors is found to be invalid, this could have a material adverse impact on our operations.

If we are not able to protect and control unpatented trade secrets, know-how and other technological innovation, we may suffer competitive harm. We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. However, trade secrets are difficult to protect. To maintain the confidentiality of trade secrets and proprietary information, we generally seek to enter into confidentiality agreements with our employees, consultants and collaborators upon the commencement of a relationship with us. However, we may not obtain these agreements in all circumstances. Nor can we guarantee that these agreements will provide meaningful protection, that these agreements will not be breached, or that we will have an adequate remedy for any such breach. In addition, adequate remedies may not exist in the event of unauthorized use or disclosure of this information. Others may have developed, or may develop in the future, substantially similar or superior know-how and technology. The loss or exposure of our trade secrets, know-how and other proprietary information, as well as independent development of similar or superior know-how, could harm our operating results, financial condition and future growth prospects. Many of our employees and consultants were, and many of our consultants may currently be, parties to confidentiality agreements with other companies. Although our confidentiality agreements with these employees and consultants require that they do not bring to us, or use without proper authorization, any third party’s proprietary technology, if they violate their agreements, we could suffer claims or liabilities.

Risks Related to Stock Market Price

The market price of our common stock is likely to be volatile.

Prior to our initial public offering in July 2004, there was no public market for our common stock. Since our initial public offering, our stock price has, at times, been volatile. We cannot assure you that an active trading market for our common stock will exist at any time. Holders of our common stock may not be able to sell shares quickly or at the market price if trading in our common stock is not active. Substantially all of our outstanding shares of our common stock are eligible for sale in the public market. For the 30 days prior to the end of the period covered by this Report, our average daily trading volume was approximately 217,000 shares. Sales of a substantial number of shares of our common stock in the public market, or the perception in the market that holders of a large number of shares intend to sell shares, could depress the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities, even if our business is doing well. In addition, the market price of our common stock could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including:

 

   

changes to the regulatory approval process for product candidates in those jurisdictions, including the U.S., in which we may be seeking approval for our product candidates;

 

   

Testim market acceptance and sales growth;

 

   

growth of the overall androgen market which may be influenced by Solvay’s sales and marketing efforts;

 

   

developments concerning therapies that compete with Testim in the treatment of hypogonadism;

 

28


   

our ability to manufacture any products to commercial standards;

 

   

results of our clinical trials;

 

   

the regulatory status of our product candidates;

 

   

failure of any of our product candidates, if approved, to achieve commercial success;

 

   

regulatory developments in the U.S. and foreign countries;

 

   

developments or disputes concerning our patents or other proprietary rights;

 

   

public concern over our drugs;

 

   

litigation involving us, our general industry or both;

 

   

future sales of our common stock;

 

   

changes in the structure of healthcare payment systems, including developments in price control legislation;

 

   

departure of key personnel;

 

   

the degree to which any co-promotion, licensing or distribution arrangements generate revenue;

 

   

period-to-period fluctuations in our financial results or those of companies that are perceived to be similar to us;

 

   

announcements of material events by those companies that are our third-party manufacturers and services providers, our partners, our competitors or perceived to be similar to us;

 

   

changes in estimates of our financial results or recommendations by securities analysts;

 

   

investors’ general perception of us; and

 

   

general economic, industry and market conditions.

Furthermore, market prices for securities of pharmaceutical, biotechnology and specialty biopharmaceutical companies have been particularly volatile in recent years. The broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. If any of these risks occurs, it could cause our stock price to fall and may expose us to class action lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Issuer Purchases of Equity Securities

The following table summarizes the Company’s purchases of its common stock for the three months ended June 30, 2007:

 

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Period

   Total Number of
Shares (or Units)
Purchased
    Average Price
Paid Per Share
(or Unit)
   Total Number of
Shares (or Units)
Purchased as
Part of Publicly
Announced
Plans or
Programs
   Maximum
Number (or
Approximate
Dollar Value) of
Shares (or Units)
that May Yet Be
Purchased
Under the Plans
or Programs

April 1, 2007 to April 30, 2007

   None       Not applicable    Not applicable    Not applicable

May 1, 2007 to May 31, 2007

   None       Not applicable    Not applicable    Not applicable

June 1, 2007 to June 30, 2007

   855 (1)   $ 16.23    Not applicable    Not applicable
                      

Total

   855 (1)   $ 16.23    Not applicable    Not applicable
                      

(1) All 855 shares were purchased from Jyrki Matilla, M.D., Ph.D., an Executive Vice President of the Company, pursuant to the Company’s 2004 Equity Compensation Plan to satisfy such individual’s tax liability with respect to the vesting of restricted stock issued in accordance with Rule 16 b-3 of the Securities Exchange Act of 1934.

Unregistered Sale of Equity Securities

None.

Use of Proceeds

None.

 

Item 4. Submission of Matters to a Vote of Security Holders.

Our 2007 Annual Meeting of Stockholders was held on June 13, 2007 at The Desmond Hotel, One Liberty Boulevard, Malvern, Pennsylvania, in accordance with the Notice of Annual Meeting of Stockholders sent on or about April 30, 2007 to all stockholders of record at the close of business on April 16, 2007. The tables below present the voting results of the matters voted upon by our stockholders at the meeting:

Proposal 1: Election of Directors

At the Annual Meeting, each of the nominees listed below was elected to our Board of Directors to serve as director until the Company’s 2008 Annual Meeting and received the votes set forth after their respective names below.

 

Name of Nominee

   For    Withheld

Al Altomari

   29,935,256    157,454

Armando Anido

   29,935,256    157,454

Rolf A. Classon

   29,649,311    443,399

Edwin A. Bescherer, Jr.

   29,934,881    157,829

Philippe O. Chambon, M.D., Ph.D.

   29,632,933    459,777

Winston J. Churchill

   29,473,450    619,260

Oliver S. Fetzer, Ph.D.

   29,648,911    443,799

Dennis J. Purcell

   29,935,256    157,454

 

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Proposal 2: Approval of an amendment and restatement of the Auxilium Pharmaceuticals, Inc. 2004 Equity Compensation Plan to (i) increase the number of shares of Company common stock authorized for issuance under the Plan from 6,000,000 to 8,000,000 shares, (ii) limit the number of shares that may be issued under the Plan pursuant to stock awards, stock units and other equity-based awards (other than stock appreciation rights) granted after June 13, 2007 to 750,000, and (iii) make other appropriate changes.

At the Annual Meeting, our stockholders approved by the vote set forth below an amendment and restatement of the Auxilium Pharmaceuticals, Inc. 2004 Equity Compensation Plan to (i) increase the number of shares of Company common stock authorized for issuance under the Plan from 6,000,000 to 8,000,000 shares, (ii) limit the number of shares that may be issued under the Plan pursuant to stock awards, stock units and other equity-based awards (other than stock appreciation rights) granted after June 13, 2007 to 750,000, and (iii) make other appropriate changes.

 

For

  

Against

  

Abstain

  

Broker Non-Votes

23,871,958    2,067,988    12,469    4,468,124

Proposal 3: Ratification of the selection of PricewaterhouseCoopers LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2007.

At the Annual Meeting, our stockholders ratified by the vote set forth below the selection of PricewaterhouseCoopers LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2007.

 

For

  

Against

  

Abstain

  

Broker Non-Votes

30,074,568    17,425    718    0

 

Item 6. Exhibits.

 

Exhibit No.  

Description of Exhibit

10.1   Placement Agency Agreement, dated June 7, 2007, by and among the Registrant, Banc of America Securities LLC and Thomas Weisel Partners LLC. (filed as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K filed on June 8, 2007, File No. 000-50855, and incorporated by reference herein).
31.1   Certification of Armando Anido, the Registrant’s Principal Executive Officer, required by Rule 13a-14(a) or Rule 15d-14(a).
31.2   Certification of James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(a) or Rule 15d-14(a).
32   Certification of Armando Anido, the Registrant’s Principal Executive Officer, and James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 

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SIGNATURES

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.

 

     AUXILIUM PHARMACEUTICALS, INC.
Date: August 8, 2007     

/s/ Armando Anido

     Armando Anido
     Chief Executive Officer and President
     (Principal Executive Officer)
Date: August 8, 2007     

/s/ James E. Fickenscher

     James E. Fickenscher
     Chief Financial Officer
     (Principal Financial and Accounting Officer)

 

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EXHIBIT INDEX

 

Exhibit No.  

Description

10.1   Placement Agency Agreement, dated June 7, 2007, by and among the Registrant, Banc of America Securities LLC and Thomas Weisel Partners LLC. (filed as Exhibit 1.1 to the Registrant’s Current Report on Form 8-K filed on June 8, 2007, File No. 000-50855, and incorporated by reference herein).
31.1   Certification of Armando Anido, the Registrant’s Principal Executive Officer, required by Rule 13a-14(a) or Rule 15d-14(a).
31.2   Certification of James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(a) or Rule 15d-14(a).
32   Certification of Armando Anido, the Registrant’s Principal Executive Officer, and James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 

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