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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 10-Q

(Mark One)  

ý

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

For the Quarterly Period Ended June 30, 2004

or

o

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

For the transition period from                             to                              

Commission file number 0-19410


Sepracor Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
  22-2536587
(IRS Employer Identification No.)

84 Waterford Drive
Marlborough, Massachusetts
(Address of Principal Executive Offices)

 

01752
(Zip Code)

Registrant's telephone number, including area code: (508) 481-6700


        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 ý    No o

        Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes ý    No o

        The number of shares outstanding of the registrant's class of Common Stock as of July 30, 2004 was: 87,605,171 shares.





SEPRACOR INC.

INDEX

Part I—Financial Information    
Item 1.   Consolidated Financial Statements (Unaudited)    
    Consolidated Balance Sheets as of June 30, 2004 and December 31,
2003 (Unaudited)
  3
    Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2004 and 2003 (Unaudited)   4
    Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2004 and 2003 (Unaudited)   5
    Notes to Consolidated Interim Financial Statements   6
Item 2.   Management's Discussion and Analysis of Financial Condition and Results of Operations   12
Item 3.   Quantitative and Qualitative Disclosures About Market Risk   35
Item 4.   Controls and Procedures   35

Part II—Other Information

 

 
Item 1.   Legal Proceedings   35
Item 4.   Submission of Matters to a Vote of Security Holders   36
Item 6.   Exhibits and Reports on Form 8-K   37
    Signatures   38
    Exhibit Index   39

2



SEPRACOR INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In Thousands)

 
  June 30, 2004
  December 31, 2003
 
Assets              
Current assets:              
Cash and cash equivalents   $ 318,440   $ 705,802  
Restricted cash     1,500     1,500  
Short-term investments     156,522     71,913  
Accounts receivable, net     44,902     50,591  
Inventories     15,901     6,866  
Other assets     18,172     17,580  
   
 
 
Total current assets     555,437     854,252  
Long-term investments     59,296     61,173  
Property and equipment, net     71,280     66,428  
Investment in affiliate     2,514     3,019  
Patents and deferred financing costs, net     28,536     34,813  
Other assets     487     540  
   
 
 
Total assets   $ 717,550   $ 1,020,225  
   
 
 

Liabilities and Stockholders' Equity (Deficit)

 

 

 

 

 

 

 
Current liabilities:              
Accounts payable   $ 18,253   $ 12,324  
Accrued expenses     110,101     127,218  
Current portion of notes payable and capital lease obligation     1,926     129  
Current portion of convertible subordinated debt         430,000  
Other current liabilities     32,073     28,757  
   
 
 
Total current liabilities     162,353     598,428  
Notes payable and capital lease obligation     3,375     789  
Long-term deferred revenue         219  
Other long-term liabilities     30,987      
Convertible subordinated debt     1,190,000     1,040,000  
   
 
 
Total liabilities     1,386,715     1,639,436  
   
 
 
Stockholders' equity (deficit):              
Preferred stock $1.00 par value, 1,000 shares authorized, none outstanding at June 30, 2004 and December 31, 2003          
Common stock, $.10 par value, 240,000 and 240,000 shares authorized; 87,586 and 85,025 shares issued and outstanding, at June 30, 2004 and December 31, 2003, respectively     8,759     8,503  
Additional paid-in capital     773,855     689,907  
Accumulated deficit     (1,461,398 )   (1,329,828 )
Accumulated other comprehensive income     9,619     12,207  
   
 
 
Total stockholders' equity (deficit)     (669,165 )   (619,211 )
   
 
 
Total liabilities and stockholders' equity (deficit)   $ 717,550   $ 1,020,255  
   
 
 

The accompanying notes are an integral part of the consolidated financial statements

3



SEPRACOR INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In Thousands, Except Per Share Amounts)

 
  Three Months Ended
  Six Months Ended
 
 
  June 30, 2004
  June 30, 2003
  June 30, 2004
  June 30, 2003
 
Revenues:                          
  Product sales   $ 57,450   $ 61,350   $ 142,506   $ 133,506  
  Royalties and other     12,517     15,105     26,939     27,455  
   
 
 
 
 
    Total revenues     69,967     76,455     169,445     160,961  
   
 
 
 
 
Costs and expenses:                          
  Cost of product sold     6,821     6,964     15,681     13,913  
  Cost of royalties and other     109     444     349     700  
  Research and development     45,077     48,255     82,373     101,438  
  Selling, marketing and distribution     86,355     36,817     170,789     72,498  
  General and administrative and patent costs     7,899     5,763     14,933     11,605  
   
 
 
 
 
    Total costs and expenses     146,261     98,243     284,125     200,154  
   
 
 
 
 
  Loss from operations     (76,294 )   (21,788 )   (114,680 )   (39,193 )
Other income (expense):                          
  Interest income     1,424     1,874     2,679     3,805  
  Interest expense     (5,830 )   (13,654 )   (11,954 )   (27,311 )
  Loss on redemption of debt             (7,022 )    
  Equity in investee (losses)     (358 )   (217 )   (505 )   (842 )
  Other income (expense), net     (71 )   (6 )   (88 )   (9 )
   
 
 
 
 
  Net loss   $ (81,129 ) $ (33,791 ) $ (131,570 ) $ (63,550 )
   
 
 
 
 
 
Basic and diluted net loss per common share

 

$

(0.93

)

$

(0.40

)

$

(1.53

)

$

(0.75

)

Shares used in computing basic and diluted net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Basic and diluted     86,797     84,469     86,006     84,409  

The accompanying notes are an integral part of the consolidated financial statements

4



SEPRACOR INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In Thousands)

 
  Six Months Ended
 
 
  June 30, 2004
  June 30, 2003
 
Cash flows from operating activities:              
  Net loss   $ (131,570 ) $ (63,550 )
Adjustments to reconcile net loss to net cash used in operating activities:              
  Depreciation and amortization     8,961     9,486  
  Provision for bad debt         268  
  Equity in investee losses     505     842  
  Loss on patent impairment     374      
  Loss on redemption of debt     7,022      
Changes in operating assets and liabilities:              
  Accounts receivable     5,689     (6,663 )
  Inventories     (9,030 )   1,757  
  Other current assets     (618 )   (805 )
  Accounts payable     5,919     (450 )
  Accrued expenses     (13,393 )   (9,079 )
  Other current liabilities     3,316     4,449  
  Other liabilities     30,768     656  
   
 
 
  Net cash used in operating activities     (92,057 )   (63,089 )
   
 
 
Cash flows from investing activities:              
  Purchases of short and long-term investments     (192,410 )   (217,724 )
  Sales and maturities of short and long-term investments     106,291     215,765  
  Additions to property and equipment     (5,415 )   (2,360 )
  Change in other assets     53      
   
 
 
  Net cash used in investing activities     (91,481 )   (4,319 )
   
 
 
Cash flows from financing activities:              
  Redemption of convertible subordinated notes     (433,709 )    
  Net proceeds from issuance of common stock     34,198     3,040  
  Proceeds from sale of convertible subordinated debt     150,000      
  Costs associated with sale of convertible subordinated debt     (4,125 )    
  Settlement of call spread options     50,006      
  Repayments of long-term debt and capital leases     (356 )   (503 )
   
 
 
  Net cash provided by (used in) financing activities     (203,986 )   2,537  
   
 
 
  Effect of exchange rate changes on cash and cash equivalents     162     (178 )
   
 
 
  Net decrease in cash and cash equivalents     (387,362 )   (65,049 )
  Cash and cash equivalents at beginning of period   $ 705,802   $ 375,438  
   
 
 
  Cash and cash equivalents at end of period   $ 318,440   $ 310,389  
   
 
 
Non cash activities:              
  Additions to capital leases     4,707      

The accompanying notes are an integral part of the consolidated financial statements

5



NOTES TO CONSOLIDATED INTERIM FINANCIAL STATEMENTS

1. Basis of Presentation

        The accompanying consolidated interim financial statements are unaudited and have been prepared on a basis substantially consistent with the audited financial statements. Certain information and footnote disclosures normally included in our annual financial statements have been condensed or omitted. The year-end consolidated condensed balance sheet data was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles. The consolidated interim financial statements, in the opinion of our management, reflect all adjustments (consisting of normal recurring accruals) necessary for a fair presentation of the results for the interim periods ended June 30, 2004 and 2003. Certain prior amounts have been reclassified to conform to current year presentation.

        The consolidated financial statements include our accounts and the accounts of our majority and wholly-owned subsidiaries, including Sepracor Canada Limited. We also have an investment in BioSphere Medical, Inc., or BioSphere, which we record under the equity method.

        The consolidated results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the fiscal year. These consolidated interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2003, which are contained in our annual report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission.

        The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the following: (1) the reported amounts of assets and liabilities, (2) the disclosure of contingent assets and liabilities at the dates of the financial statements and (3) the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

2. Basic and Diluted Net Loss Per Common Share

        Basic earnings (loss) per share, or EPS, excludes dilution and is computed by dividing net income by the weighted-average number of common shares outstanding for the period. Diluted EPS is based upon the weighted average number of common shares outstanding during the period plus the additional weighted average common equivalent shares during the period. Common equivalent shares are not included in the per share calculations where the effect of their inclusion would be anti-dilutive. Common equivalent shares result from the assumed conversion of preferred stock, convertible subordinated debt and the assumed exercise of outstanding stock options, the proceeds of which are then assumed to have been used to repurchase outstanding stock options using the treasury stock method. Purchased call options are also not included in the per share calculations because including them would be anti-dilutive.

        For the three and six months ended June 30, 2004 and 2003, basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding during the period because the effect of common stock equivalents would be anti-dilutive. Certain securities were not included in the computation of diluted earnings per share for the three and six

6



months ended June 30, 2004 and 2003 because they would have an anti-dilutive effect due to net losses for such periods. These excluded securities include the following:

        Options to purchase shares of common stock:

(in thousands, except price per share data)

  June 30, 2004
  June 30, 2003
Number of options     12,189     12,698
Price range per share   $ 2.63 to $87.50   $ 2.50 to $87.50

        Shares of common stock reserved for issuance upon conversion of convertible subordinated debt:

(in thousands)

  June 30, 2004
  June 30, 2003
7% convertible subordinated debentures due 2005     1,792
5% convertible subordinated debentures due 2007   4,763   4,763
5.75% convertible subordinated notes due 2006     7,166
0% Series A convertible senior subordinated notes due 2008   7,839  
0% Series B convertible senior subordinated notes due 2010   16,756  
   
 
    29,358   13,721
   
 

3. Accounting for Stock-Based Compensation

        We have elected to follow Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees", or APB 25, and related interpretations, in accounting for our stock-based compensation plans, rather than the alternative fair value accounting method provided for under FASB Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation", or SFAS No. 123. Under APB 25, when the exercise price of options granted under these plans equals the market price of the underlying stock on the date of grant, no compensation expense is recognized.

        The following table illustrates the effect on net loss and loss per share if we had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation:

 
  Three Months
Ended June 30,

  Six Months
Ended June 30,

 
(in thousands, except per share data)

 
  2004
  2003
  2004
  2003
 
Net loss attributable to common stockholders   $ (81,129 ) $ (33,791 ) $ (131,570 ) $ (63,550 )
Total stock-based employee compensation expense determined under fair value based method for all awards     (11,757 )   (14,977 )   (22,795 )   (29,380 )
   
 
 
 
 
Pro forma net loss   $ (92,886 ) $ (48,768 ) $ (154,365 ) $ (92,930 )
   
 
 
 
 
Amounts per common share:                          
Basic and diluted—as reported   $ (0.93 ) $ (0.40 ) $ (1.53 ) $ (0.75 )

Basic and diluted—pro forma

 

$

(1.07

)

$

(0.58

)

$

(1.79

)

$

(1.10

)

7


4. Inventories

        Inventories consist of the following:

(in thousands)

  June 30, 2004
  December 31, 2003
Raw materials   $ 2,954   $ 1,062
Work in progress     1,858     1,295
Finished goods     11,089     4,509
   
 
    $ 15,901   $ 6,866
   
 

5. Patents and Deferred Financing Costs

        The following schedule details the carrying value of our patents and deferred financing costs as of June 30, 2004 and December 31, 2003:

(in thousands)

  June 30, 2004
  December 31, 2003
 
Deferred finance costs, gross   $ 35,147   $ 42,957  
Accumulated amortization     (10,882 )   (13,136 )
   
 
 
Deferred finance costs, net   $ 24,265   $ 29,821  
   
 
 
Patents, gross   $ 6,679   $ 7,223  
Accumulated amortization     (2,408 )   (2,231 )
   
 
 
Patents, net   $ 4,271   $ 4,992  
   
 
 

        The following schedule details our amortization expense related to patents and deferred financing costs:

 
  Three Months
Ended June 30,

  Six Months
Ended June 30,

(in thousands)

  2004
  2003
  2004
  2003
Amortization of deferred finance costs   $ 1,326   $ 1,222   $ 2,706   $ 2,444
Amortization of patents     174     943     348     1,829
   
 
 
 
Total amortization   $ 1,500   $ 2,165   $ 3,054   $ 4,273
   
 
 
 

        We currently estimate that our amortization expense will be $2,973,000, $5,943,000, $5,917,000, $4,283,000 and $3,893,000 for the remainder of 2004 and for the years ending December 31, 2005, 2006, 2007 and 2008, respectively.

        During the second quarter of 2004, we recorded a charge of approximately $374,000 related to the impairment of all patents related to ticalopride (formerly known as (+)- norcisapride). This impairment of patents related to our termination, during the second quarter of 2004, of all plans for development of ticalopride. This charge is included in research and development expense in the consolidated statements of operations for the three and six months ended June 30, 2004.

8



6. Convertible Subordinated Debt

        Convertible subordinated debt, including current portion, consists of the following:

(in thousands)

  June 30, 2004
  December 31, 2003
5.75% convertible subordinated notes due 2006   $   $ 430,000
5% convertible subordinated debentures due 2007     440,000     440,000
0% Series A convertible senior subordinated notes due 2008     250,000     200,000
0% Series B convertible senior subordinated notes due 2010     500,000     400,000
   
 
Total   $ 1,190,000   $ 1,470,000
   
 

        On January 9, 2004, using funds from our December 2003 issuance of 0% convertible senior subordinated notes, we redeemed the remaining outstanding $430,000,000 principal amount of our 5.75% convertible subordinated notes due 2006 for an aggregate redemption price of $433,709,000, including approximately $3,709,000 in accrued interest. As a result of this redemption, we recorded a loss of approximately $7,022,000 related to the write-off of deferred financing costs in the first quarter of 2004.

        On January 15, 2004, pursuant to an option granted to the initial purchasers of our 0% convertible senior subordinated notes, we issued an additional $50,000,000 of 0% Series A convertible senior subordinated notes due 2008 and $100,000,000 of 0% Series B convertible senior subordinated notes due 2010. These notes have the same terms and conditions as our previously issued 0% notes. Net of issuance costs, our proceeds were approximately $145,875,000.

7. Equity

        During the second quarter of 2004, pursuant to the call spread option agreements we entered into in December 2003, we settled 1,639,832 call spread options for cash in the amount of $50,006,000. The settled options expired at various dates beginning on May 12, 2004 and ending on June 9, 2004. We recorded the full amount of the call spread option settlement as an increase to additional paid-in capital. Our remaining outstanding call spread options expire at various dates through 2005 and we have the option to settle the remaining outstanding call spread options in either net shares or in cash.

8. Comprehensive Loss

        Total comprehensive loss consists of net loss, net foreign currency translation adjustments and net unrealized gain (loss) on available-for-sale securities.

 
  Three Months Ended
  Six Months Ended
 
(in thousands)

  June 30, 2004
  June 30, 2003
  2004 June 30,
  June 30, 2003
 
Comprehensive loss:                          
Net loss   $ (81,129 ) $ (33,791 ) $ (131,570 ) $ (63,550 )
Net foreign currency translation adjustment     5     (96 )   825     (105 )
Net unrealized gain (loss) on available-for-sale securities     (7,182 )   6,724     (3,413 )   6,740  
   
 
 
 
 
Total comprehensive loss   $ (88,306 ) $ (27,163 ) $ (134,158 ) $ (56,915 )
   
 
 
 
 

9


9. Commitments and Contingencies

        We enter into indemnification agreements in our ordinary course of business pursuant to which we indemnify and hold harmless certain parties against claims, liabilities and losses brought by a third party to the extent that the claims arise out of (1) injury or death to person or property caused by defects in our product or product candidates, (2) negligence in the manufacture or distribution of our product or product candidates or (3) a material breach by us. We have no liabilities recorded for these guarantees at June 30, 2004. If liabilities were incurred, we have insurance policies covering product liabilities, which should mitigate, but may not eliminate, losses.

        We have agreements whereby we indemnify our officers and directors for certain events or occurrences while the officer or director is, or was, serving at our request in such capacity. The term of the indemnification period is for the officer's or director's lifetime. The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited; however, we believe the fair value of these indemnification agreements is minimal.

        The Securities and Exchange Commission is conducting an investigation into trading in our securities, including trading by certain of our officers and employees during the period from January 1, 1998 through December 31, 2001. We have cooperated fully with the investigation and will continue to do so.

        We and several of our current and former officers and a current director are named as defendants in several purported class action complaints which have been filed on behalf of certain persons who purchased our common stock and/or debt securities during different time periods, beginning on various dates, the earliest being May 17, 1999, and all ending on March 6, 2002. These complaints allege violations of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder by the Securities and Exchange Commission. Primarily they allege that the defendants made certain materially false and misleading statements relating to the testing, safety and likelihood of approval of tecastemizole (formerly SOLTARA™) by the United States Food and Drug Administration, or FDA. On April 11, 2003, two consolidated amended complaints were filed, one on behalf of the purchasers of our common stock and the other on behalf of the purchasers of our debt securities. These consolidated amended complaints reiterate the allegations contained in the previously filed complaints and define the alleged class periods as May 17, 1999 through March 6, 2002. We filed a motion to dismiss both consolidated amended complaints on May 27, 2003. On March 11, 2004, the court, while granting in part the motion to dismiss, did allow much of the case to proceed. The parties are currently engaged in discovery.

        We are unable to reasonably estimate any possible range of loss related to these lawsuits due to their uncertain resolution.

10. Ross Agreement Amendment

        On March 25, 2004, we announced an amendment to our agreement with the Ross Products Division of Abbott Laboratories, or Ross, for the co-promotion of XOPENEX® brand levalbuterol HCl inhalation solution. Under the terms of the amendment, our agreement with Ross will terminate effective December 31, 2004. Ross will continue to co-promote XOPENEX through December 31, 2004. Under the terms of the amendment, we will make residual payments to Ross of $30,000,000 on or before December 31, 2005 and $3,000,000 on or before December 31, 2006. We charged the present value of these payments, approximately $30,671,000, to selling, marketing and distribution expense in the first quarter of 2004 and this amount is included on the balance sheet in other long-term liabilities as of June 30, 2004. The difference between the payment amounts and the present value will be

10



accreted to interest expense at a rate of $317,000 per quarter through the end of 2005 and then $28,000 per quarter in 2006.

11. MedPointe Agreement Amendment

        On April 30, 2004, we entered into an amendment to our agreement with MedPointe Inc., or MedPointe, for the co-promotion of ASTELIN® brand azelastine HCl for the treatment of allergic rhinitis. Under the terms of the amendment, effective July 1, 2004 our sales force is only responsible for providing ASTELIN samples to doctors. Effective October 1, 2004, both parties have the unilateral right to terminate the agreement without cause. As of the amendment date, we began recognizing revenue at the fair value of services as those services are performed. If the agreement is terminated by either party, we will receive a payment from MedPointe of $6,950,000, less any amount received prior to the termination related to the sample coverage.

11



ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

        This quarterly report on Form 10-Q contains, in addition to historical information, forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking state