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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q


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

For the Quarterly Period Ended June 30, 2003

Commission file number: 0-27406

CONNETICS CORPORATION

(Exact name of registrant as specified in its charter)
     
Delaware   94-3173928
(State or other jurisdiction of
incorporation or organization)
  (IRS Employer
Identification Number)
 
3290 West Bayshore Road
Palo Alto, California
(Address of principal executive offices)
  94303
(Zip Code)

Registrant’s telephone number, including area code: (650) 843-2800

     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 an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes [X] No [ ]

     As of August 8, 2003, 31,692,935 shares of the Registrant’s common stock were outstanding, at $0.001 par value.



 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds
Item 4. Submission of Matters to a Vote of Security Holders
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits.
(b) Reports on Form 8-K
EXHIBIT 4.1
EXHIBIT 4.2
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1
EXHIBIT 32.2


Table of Contents

CONNETICS CORPORATION

TABLE OF CONTENTS

                 
            Page
           
PART I FINANCIAL INFORMATION
  Item 1.   Condensed Consolidated Financial Statements        
        Condensed Consolidated Balance Sheets at June 30, 2003 and December 31, 2002     3  
        Condensed Consolidated Statements of Operations for the Three and Six Months ended June 30, 2003 and 2002     4  
        Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2003 and 2002     5  
        Notes to Condensed Consolidated 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     17  
  Item 4.   Controls and Procedures     17  
PART II OTHER INFORMATION
  Item 2.   Changes in Securities and Use of Proceeds     18  
  Item 4.   Submission of Matters to a Vote of Security Holders     18  
  Item 6.   Exhibits and Reports on Form 8-K     19  
        (a) Exhibits     19  
        (b) Reports on Form 8-K     19  
  Signatures         21  

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CONNETICS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)

                     
        June 30,   December 31,
        2003   2002
       
 
ASSETS
Current assets:
               
 
Cash and cash equivalents
  $ 47,562     $ 8,624  
 
Short-term investments
    65,977       24,440  
 
Restricted cash
    411       424  
 
Accounts receivable, net of allowances
    260       4,308  
 
Prepaid and other current assets
    3,480       1,803  
 
   
     
 
   
Total current assets
    117,690       39,599  
Property and equipment, net
    5,786       5,860  
Restricted cash
          300  
Deposits and other assets
    5,059       848  
Goodwill, net
    6,271       6,271  
Other intangible assets, net
    6,622       6,675  
 
   
     
 
Total assets
  $ 141,428     $ 59,553  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
               
 
Accounts payable
  $ 4,953     $ 7,760  
 
Accrued clinical trial costs
    1,599       1,223  
 
Accrued payroll and related expenses
    2,006       2,942  
 
Accrued process development expenses
    606       633  
 
Other accrued liabilities
    1,865       1,493  
 
Current portion of deferred revenue
    380       363  
 
   
     
 
   
Total current liabilities
    11,409       14,414  
Deferred revenue, net of current portion
    329       396  
Convertible senior notes
    90,000        
Stockholders’ equity:
               
 
Preferred stock
           
 
Common stock
    32       31  
 
Additional paid-in capital
    172,407       169,769  
 
Deferred compensation
    (39 )     (48 )
 
Accumulated deficit
    (133,325 )     (126,088 )
 
Accumulated other comprehensive income
    615       1,079  
 
   
     
 
   
Total stockholders’ equity
    39,690       44,743  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 141,428     $ 59,553  
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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CONNETICS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

                                     
        Three Months Ended   Six Months Ended
        June 30,   June 30,
       
 
        2003   2002   2003   2002
       
 
 
 
Revenues:
                               
 
Product
  $ 15,528     $ 11,423     $ 29,839     $ 21,563  
 
Royalty
    4,384       766       5,320       1,416  
 
License, contract and other
    58       437       122       1,178  
 
 
   
     
     
     
 
   
Total revenues
    19,970       12,626       35,281       24,157  
 
 
   
     
     
     
 
Operating costs and expenses:
                               
 
Cost of product revenues
    1,185       973       2,257       1,648  
 
Research and development
    8,619       5,613       17,236       10,653  
 
Selling, general and administrative
    10,792       10,746       21,896       20,327  
 
Acquired in-process research and development
          2,000             2,000  
 
Loss on program termination
          312             312  
 
 
   
     
     
     
 
 
Total operating costs and expenses
    20,596       19,644       41,389       34,940  
 
 
   
     
     
     
 
Loss from operations
    (626 )     (7,018 )     (6,108 )     (10,783 )
Interest income
    169       217       294       496  
Gain on sale of investment
          1,552             1,570  
Interest expense
    (230 )     (4 )     (231 )     (6 )
Other income (expense), net
    33       93       87       171  
 
 
   
     
     
     
 
Loss before income taxes
    (654 )     (5,160 )     (5,958 )     (8,552 )
Income tax benefit (provision)
    (1,202 )     (161 )     (1,279 )     63  
 
 
   
     
     
     
 
Net loss
  $ (1,856 )   $ (5,321 )   $ (7,237 )   $ (8,489 )
 
 
   
     
     
     
 
Basic and diluted loss per share
  $ (0.06 )   $ (0.17 )   $ (0.23 )   $ (0.28 )
 
 
   
     
     
     
 
Shares used to calculate basic and diluted loss per share
    31,519       30,608       31,403       30,552  
 
 
   
     
     
     
 

See accompanying notes to condensed consolidated financial statements.

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CONNETICS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

                     
        Six Months Ended
        June 30,
       
        2003   2002
       
 
Cash flows from operating activities:
               
 
Net loss
  $ (7,237 )   $ (8,489 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation
    649       614  
   
Amortization of intangible assets and debt issuance costs
    459       408  
   
Allowance for rebates, returns and chargebacks
    2,150       448  
   
Gain on sale of investment
          (1,570 )
   
Stock compensation expense
    9       12  
   
Stock issued pursuant to license agreement
          12  
 
Changes in assets and liabilities:
               
   
Accounts receivable, net
    1,909       840  
   
Other assets
    (2,440 )     (778 )
   
Accounts payable
    (2,997 )     3,073  
   
Accrued and other current liabilities
    (373 )     (1,719 )
   
Deferred revenue
    (48 )     (316 )
 
 
   
     
 
 
Net cash used in operating activities
    (7,919 )     (7,465 )
 
 
   
     
 
Cash flows from investing activities:
               
 
Purchases of short-term investments
    (59,974 )     (19,405 )
 
Sales and maturities of short-term investments
    17,903       30,415  
 
Purchases of property and equipment
    (423 )     (2,463 )
 
Acquisition of patent
    (200 )      
 
 
   
     
 
 
Net cash provided by (used in) investing activities
    (42,694 )     8,547  
 
 
   
     
 
Cash flows from financing activities:
               
 
Restricted cash
    312       1,429  
 
Proceeds from issuance of convertible senior notes, net of issuance costs
    86,503        
 
Proceeds from issuance of common stock, net of issuance costs
    2,638       2,919  
 
 
   
     
 
 
Net cash provided by financing activities
    89,453       4,348  
 
 
   
     
 
 
Effect of foreign currency exchange rates on cash and cash equivalents
    98       125  
 
 
   
     
 
 
Net change in cash and cash equivalents
    38,938       5,555  
 
Cash and cash equivalents at beginning of period
    8,624       3,603  
 
 
   
     
 
 
Cash and cash equivalents at end of period
  $ 47,562     $ 9,158  
 
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1.     Basis of Presentation and Policies

     We have prepared the accompanying unaudited condensed consolidated financial statements of Connetics Corporation (“Connetics”) in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, the financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. We believe that we have included all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation. We have reclassified certain prior year balances to conform to the current year’s presentation.

     Operating results for the six months ended June 30, 2003 are not necessarily indicative of the results that may be expected for the year ended December 31, 2003. For a better understanding of Connetics and its financial statements, we recommend reading these unaudited, condensed, consolidated financial statements and notes in conjunction with the audited consolidated financial statements and notes to those financial statements for the year ending December 31, 2002, which are included in our Annual Report on Form 10-K/A as filed with the Securities and Exchange Commission.

Principles of Consolidation

     The accompanying consolidated financial statements include the accounts of Connetics Corporation, Connetics Holdings Pty Ltd., and Connetics Australia Pty Ltd. (formerly Soltec Research Pty Ltd.). All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

     To prepare financial statements in conformity with accounting principles generally accepted in the United States, management must make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates based upon future events.

     We evaluate our estimates on an on-going basis, including those related to recoverability of accounts receivable and inventory, revenue recognition and accrued liabilities for clinical trial activities. We base our estimations on historical experience and on various other specific assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Revenue Recognition

     Product Sales. We recognize revenue from product sales when there is persuasive evidence that an arrangement exists, when title has passed, the price is fixed or determinable, and collection of the resulting receivable is reasonably assured. We recognize product revenue net of estimated allowances for discounts, rebates, returns and chargebacks. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We authorize returns for damaged products and exchanges for expired products in accordance with our return goods policy and procedures, and we establish reserves for such amounts at the time of sale. To date we have not experienced significant returns of damaged or expired product. Product shipping and handling costs are included in the cost of product revenues.

     Royalty Revenue. Royalties from licensees are based on third-party sales. We recognize royalties in the quarter in which the royalty payment is either received from the licensee or may be reasonably estimated, which is typically one quarter following the related sale by the licensee.

     Contract Revenue. We record contract revenue for research and development, or R&D, as it is earned based on the performance requirements of the contract. We recognize non-refundable contract fees for which no further performance obligations exist, and for which Connetics has no continuing involvement, on the earlier of when the payments are received or when collection is assured.

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     We recognize revenue from non-refundable upfront license fees ratably over the period in which we have continuing development obligations when, at the time the agreement is executed, there remains significant risk due to the incomplete state of the product’s development. We recognize revenue associated with substantial “at risk” performance milestones, as defined in the respective agreements, based upon the achievement of the milestones. We recognize revenue under R&D cost reimbursement contracts as the related costs are incurred. Advance payments that we receive in excess of amounts earned are classified as deferred revenue until they are earned.

Cash Equivalents and Short-term Investments

     Cash and cash equivalents consist of cash on deposit with banks and money market instruments with original maturities of 90 days or less at the date of purchase. Investments with maturities beyond three months at the date of acquisition and that mature within one year from the balance sheet date are considered to be short-term investments. Short-term investments are classified as available for sale at the time of purchase and are carried at fair value, and we report unrealized gains and losses as a separate component of stockholders’ equity. We determine the cost of securities sold using the specific identification method.

     Cash equivalents and short term investments are financial instruments that potentially subject us to concentration of risk to the extent recorded on the balance sheet. We believe we have established guidelines for investing our excess cash with respect to diversification and maturities that maintain safety and liquidity. We invest our excess cash in debt instruments of the U.S. Government and its agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits. To minimize the exposure due to adverse shifts in interest rates, we maintain investments at an average maturity of generally less than one year.

Foreign Currency

     Connetics Australia’s functional currency is the Australian dollar. We translate Connetics Australia’s local currency balance sheet into U.S. dollars using the exchange rates in effect at the balance sheet date; for revenue and expense accounts we use a weighted average exchange rate during the period. Foreign currency translation adjustments are recorded in comprehensive income (loss). Net gains and losses resulting from foreign exchange transactions are included in the consolidated statements of operations and were immaterial for all periods presented.

Income Taxes

     We account for income taxes using the asset and liability method. Under this method, we recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between (1) the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (2) operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates that are expected to apply to taxable income in the years in which we anticipate those temporary differences will be recovered or settled. We establish a valuation for the net deferred tax assets when realization is uncertain.

Property and Equipment

     Property and equipment are stated at cost less accumulated depreciation. We calculate depreciation using the straight-line method over the estimated useful lives of the assets, generally three to five years. We amortize leasehold improvements and assets acquired under capital lease arrangements over the shorter of the estimated useful lives of the assets or the lease term.

Goodwill, Purchased Intangibles and Impairment of Long Lived Assets

     We record goodwill in a business combination when the purchase price of the net tangible and intangible assets we acquire exceeds their fair value. Under Statement of Financial Accounting Standards (SFAS) No. 142, “Goodwill and Other Intangible Assets,” effective January 1, 2002, we are not required to amortize goodwill and

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intangible assets with indefinite lives, but are required to periodically review these assets for impairment. Intangible assets determined to have definite lives are amortized over their useful lives, which in our case is ten years.

     We adopted SFAS 142 effective January 1, 2002, and in conjunction with the implementation of SFAS 142 we performed an impairment test of goodwill as of that date, which did not result in an impairment charge at transition. SFAS 142 also requires that we test goodwill for impairment on an annual basis or more frequently if indicators of potential impairment exist. We performed the annual test as of October 1, 2002, which did not result in an impairment charge. We will perform this test on October 1 of each year or more frequently if indicators of potential impairment exist.

     We periodically perform reviews to determine if the carrying value of long-term assets, other than goodwill (purchased intangibles, property and equipment), is impaired. The reviews look for the existence of facts or circumstances, either internal or external, which indicate that the carrying value of the asset cannot be recovered. No such impairment has been indicated to date. If in the future we determine the existence of impairment indicators, we would use undiscounted cash flows to initially determine whether impairment should be recognized. If necessary, we would perform a subsequent calculation to measure the amount of impairment loss based on the excess of the carrying value over the fair value of the impaired assets. If quoted market prices for the assets are not available, we would calculate the fair value using the present value of estimated expected future cash flows or other appropriate valuation methodologies. The cash flow calculation would be based on management’s best estimates, using appropriate assumption and projections at the time.

Stock-Based Compensation

     We use the intrinsic-value method of accounting for stock-based awards granted to employees, as allowed under Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (APB 25) and related interpretations. Accordingly, we do not recognize any compensation in our financial statements in connection with stock options granted to employees with exercise prices not less than fair market value. We also do not record any compensation expense in connection with our Employee Stock Purchase Plan as long as the purchase price is not less than 85% of the fair market value at the beginning or end of each offering period, whichever is lower.

     For options granted to non-employees, we have determined compensation expense in accordance with SFAS No. 123 and Emerging Issues Task Force No. 96-18, as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. We periodically re-measure the compensation expense for options granted to non-employees as they vest.

     Although SFAS 123 allows us to continue to follow the present APB 25 guidelines, we are required to disclose pro forma net loss and basic and diluted loss per share as if the fair value based method had been applied to all awards.

                                   
      Three Months Ended   Six Months Ended
      June 30,   June 30,
     
 
(in thousands except per share amounts):   2003   2002   2003   2002

 
 
 
 
Net loss, as reported
  $ (1,856 )   $ (5,321 )   $ (7,237 )   $ (8,489 )
Add: Stock –based compensation expense, included in reported net loss
    5       4       9       12  
Deduct: Total stock-based employee compensation expense determined under the fair value method for all awards
    (2,017 )     (923 )     (3,766 )     (2,115 )
 
   
     
     
     
 
Pro forma net loss
  $ (3,868 )   $ (6,240 )   $ (10,994 )   $ (10,592 )
 
   
     
     
     
 
Loss per share:
                               
 
Basic and diluted loss — as reported
  $ (0.06 )   $ (0.17 )   $ (0.23 )   $ (0.28 )
 
Basic and diluted loss — pro forma
  $ (0.12 )   $ (0.20 )   $ (0.35 )   $ (0.35 )
 
   
     
     
     
 

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     For purposes of this analysis, we estimate the fair value of each option grant on the date of grant using the Black-Scholes option-pricing model. The weighted average assumptions used in the model were as follows:

                                 
    Stock Option Plans
   
    Three Months Ended   Six Months Ended
    June 30,   June 30,
   
 
    2003   2002   2003   2002
   
 
 
 
Expected stock volatility
    61.64 %     65.28 %     63.51 %     65.28 %
Risk-free interest rate
    4.38 %     4.63 %     5.86 %     4.63 %
Expected life (in years)
    3.15    </