UNITED STATES SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31, 2003
Commission file number: 0-27406
CONNETICS CORPORATION
| Delaware | 94-3173928 | |
| (State or other jurisdiction of | (IRS Employer | |
| incorporation or organization) | Identification Number) |
3290 West Bayshore Road
Palo Alto, California 94303
(Address of principal executive offices)
Registrants 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 at least 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 May 9, 2003, 31,511,948 shares of the Registrants common stock were outstanding, at $0.001 par value.
CONNETICS CORPORATION
TABLE OF CONTENTS
| Page | ||||
| PART I FINANCIAL INFORMATION | ||||
| Item 1. | Condensed Consolidated Financial Statements | 1 | ||
| Condensed Consolidated Balance Sheets at March 31, 2003 and December 31, 2002 | 1 | |||
| Condensed Consolidated Statements of Operations for the three months ended March 31, 2003 and 2002 | 2 | |||
| Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2003 and 2002 | 3 | |||
| Notes to Condensed Consolidated Financial Statements | 4 | |||
| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 10 | ||
| Item 3. | Quantitative and Qualitative Disclosures About Market Risks | 15 | ||
| Item 4. | Controls and Procedures | 15 | ||
| PART II OTHER INFORMATION | ||||
| Item 6. | Exhibits and Reports on Form 8-K | 15 | ||
| (a) Exhibits | 15 | |||
| (b) Reports on Form 8-K | 15 |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONNETICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
| March 31, | December 31, | |||||||||
| 2003 | 2002 | |||||||||
ASSETS |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 9,057 | $ | 8,624 | ||||||
Short-term investments |
19,416 | 24,440 | ||||||||
Restricted cash |
411 | 424 | ||||||||
Accounts receivable, net |
2,331 | 4,308 | ||||||||
Prepaid and other current assets |
1,468 | 1,803 | ||||||||
Total current assets |
32,683 | 39,599 | ||||||||
Property and equipment, net |
5,754 | 5,860 | ||||||||
Restricted cash |
| 300 | ||||||||
Deposits and other assets |
750 | 848 | ||||||||
Goodwill |
6,271 | 6,271 | ||||||||
Other intangible assets, net |
6,474 | 6,675 | ||||||||
Total assets |
$ | 51,932 | $ | 59,553 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||
Current liabilities: |
||||||||||
Accounts payable |
$ | 5,408 | $ | 7,760 | ||||||
Accrued clinical trial costs |
2,051 | 1,223 | ||||||||
Accrued payroll and related expenses |
1,830 | 2,942 | ||||||||
Accrued process development expenses |
607 | 633 | ||||||||
Other accrued liabilities |
940 | 1,493 | ||||||||
Current portion of deferred revenue |
332 | 363 | ||||||||
Total current liabilities |
11,168 | 14,414 | ||||||||
Deferred revenue, net of current portion |
363 | 396 | ||||||||
Stockholders equity: |
||||||||||
Preferred stock |
| | ||||||||
Common stock |
31 | 31 | ||||||||
Additional paid-in capital |
170,990 | 169,769 | ||||||||
Deferred compensation |
(44 | ) | (48 | ) | ||||||
Accumulated deficit |
(131,469 | ) | (126,088 | ) | ||||||
Accumulated other comprehensive income |
893 | 1,079 | ||||||||
Total stockholders equity |
40,401 | 44,743 | ||||||||
Total liabilities and stockholders equity |
$ | 51,932 | $ | 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 | ||||||||||
| March 31, | ||||||||||
| 2003 | 2002 | |||||||||
Revenues: |
||||||||||
Product |
$ | 14,311 | $ | 10,140 | ||||||
Royalty |
936 | 649 | ||||||||
License, contract and other |
64 | 742 | ||||||||
Total revenues |
15,311 | 11,531 | ||||||||
Operating costs and expenses: |
||||||||||
Cost of product revenues |
1,072 | 675 | ||||||||
Research and development |
8,617 | 5,040 | ||||||||
Selling, general and administrative |
11,104 | 9,581 | ||||||||
Total operating costs and expenses |
20,793 | 15,296 | ||||||||
Loss from operations |
(5,482 | ) | (3,765 | ) | ||||||
Interest
and other income |
179 | 357 | ||||||||
Gain on sale of investment |
| 18 | ||||||||
Interest expense |
(1 | ) | (2 | ) | ||||||
Loss before income taxes |
(5,304 | ) | (3,392 | ) | ||||||
Income tax benefit (expense) |
(77 | ) | 224 | |||||||
Net loss |
$ | (5,381 | ) | $ | (3,168 | ) | ||||
Basic and diluted loss per share |
$ | (0.17 | ) | $ | (0.10 | ) | ||||
Shares
used to calculate basic and diluted loss per share |
31,286 | 30,496 | ||||||||
See accompanying notes to condensed consolidated financial statements.
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CONNETICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Three Months Ended | ||||||||||
| March 31, | ||||||||||
| 2003 | 2002 | |||||||||
Cash flows from operating activities: |
||||||||||
Net loss |
$ | (5,381 | ) | $ | (3,168 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||
Depreciation |
389 | 316 | ||||||||
Amortization of intangible assets |
201 | 205 | ||||||||
Gain on sale of investment |
| (18 | ) | |||||||
Stock compensation expense |
4 | 8 | ||||||||
Stock issued pursuant to license agreement |
| 12 | ||||||||
Changes in assets and liabilities: |
||||||||||
Accounts receivable, net |
1,983 | (29 | ) | |||||||
Other assets |
434 | (166 | ) | |||||||
Accounts payable |
(2,415 | ) | (52 | ) | ||||||
Accrued and other current liabilities |
(858 | ) | (1,660 | ) | ||||||
Deferred revenue |
(64 | ) | (159 | ) | ||||||
Net cash used in operating activities |
(5,707 | ) | (4,711 | ) | ||||||
Cash flows from investing activities: |
||||||||||
Purchases of short-term investments |
(4,878 | ) | (10,527 | ) | ||||||
Sales and maturities of short-term investments |
9,677 | 15,052 | ||||||||
Purchases of property and equipment |
(231 | ) | (982 | ) | ||||||
Net cash provided by investing activities |
4,568 | 3,543 | ||||||||
Cash flows from financing activities: |
||||||||||
Restricted cash |
313 | 821 | ||||||||
Payment of notes payable |
| (23 | ) | |||||||
Proceeds from issuance of common stock, net of issuance costs |
1,221 | 1,867 | ||||||||
Net cash provided by financing activities |
1,534 | 2,665 | ||||||||
Effect of foreign currency exchange rates on cash and cash equivalents |
38 | 56 | ||||||||
Net change in cash and cash equivalents |
433 | 1,553 | ||||||||
Cash
and cash equivalents at beginning of period |
8,624 | 3,603 | ||||||||
Cash
and cash equivalents at end of period |
$ | 9,057 | $ | 5,156 | ||||||
See accompanying notes to condensed consolidated financial statements.
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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.
Operating results for the three months ended March 31, 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. We have reclassified certain prior year balances to conform to the current years presentation.
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.
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 and 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 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.
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 products development. Revenue associated with substantial at risk performance
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milestones, as defined in the respective agreements, is recognized 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. The cost of securities sold is determined on the specific identification method.
Cash equivalents and 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 investment of 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 Australias functional currency is the Australian dollar. We translate Connetics Australias 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 statement 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 expected to apply to taxable income in the years in which those temporary differences are expected to 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. Leasehold improvements and assets acquired under capital lease arrangements are amortized 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 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. We amortize other intangible assets that meet the criteria for separate recognition from goodwill over their useful lives of ten years.
We adopted SFAS 142 effective January 1, 2002. In conjunction with the implementation of SFAS 142 we performed an impairment test of goodwill as of January 1, 2002, 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
5
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, including 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 managements 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 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 the underlying options vest.
Although SFAS 123 allows us to continue to follow the present APB 25 guidelines, we are required to disclose pro forma net income (loss) and basic and diluted earnings per share as if the fair value based method had been applied to all awards.
| Three Months Ended | |||||||||
| March 31, | |||||||||
| (in thousands except per share amounts): | 2003 | 2002 | |||||||
Net loss, as reported |
$ | (5,381 | ) | $ | (3,168 | ) | |||
Add: Stock based compensation
expense, included in reported net loss,
net of related tax effect |
4 | 8 | |||||||
Deduct: Total stock-based employee
compensation expense determined under
the fair value method for all awards,
net of related tax effects |
(1,749 | ) | (1,192 | ) | |||||
Pro forma net loss |
$ | (7,126 | ) | $ | (4,352 | ) | |||
Earnings per share: |
|||||||||
Basic and diluted loss as reported |
$ | (0.17 | ) | $ | (0.10 | ) | |||
Basic and diluted loss pro forma |
$ | (0.23 | ) | $ | (0.14 | ) | |||
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:
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| Stock Option Plans | Stock Purchase Plans | |||||||||||||||
| Three Months Ended | Three Months Ended | |||||||||||||||
| March 31, | March 31, | |||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||
Expected stock volatility |
64.0 | % | 70.0 | % | 66.0 | % | 83.0 | % | ||||||||
Risk-free interest rate |
6.25 | % | 5.63 | % | 4.97 | % | 5.98 | % | ||||||||
Expected life (in years) |
4.24 | 3.77 | 1.31 | 1.36 | ||||||||||||
Expected dividend yield |
0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | ||||||||
The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility. Because our stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, we do not believe that the existing models necessarily provide a reliable single measure of the fair value of our options.
The effects on pro forma disclosures of applying SFAS 123 are not likely to be representative of the effects on reported results of future periods.
Recent Accounting Pronouncements
SFAS 146. In July 2002, the FASB issued Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit and Disposal Activities (SFAS 146). This statement revises the accounting for exit and disposal activities under Emerging Issues Task Force Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity. Specifically, SFAS 146 requires that companies record the costs to exit an activity or dispose of long-lived assets when those costs are incurred. SFAS 146 requires that the measurement of the liability be at fair value. The provisions of SFAS 146 are effective prospectively for exit or disposal activities initiated after December 31, 2002. Adoption of SFAS 146 did not have a significant impact on our financial statements.
FIN 45. In November 2002, the FASB issued Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45). FIN 45 requires that upon issuance of a guarantee, the guarantor must recognize a liability for the fair value of the obligation it assumes under that guarantee. FIN 45 is effective on a prospective basis to guarantees issued or modified after December 31, 2002. The disclosure requirements of FIN 45 are effective for financial statements of interim or annual periods ending after December 15, 2002. The adoption of FIN 45 did not have a significant impact on our financial statements.
FIN 46. In January 2003, the FASB issued Interpretation 46, Consolidation of Variable Interest Entities (FIN 46). FIN 46 requires that companies that control another entity through interests other than voting interests should consolidate the controlled entity. FIN 46 applies to variable interest entities created after January 31, 2003, and to variable interest entities in which an enterprise obtains an interest after that date. The consolidation requirements apply to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain disclosure requirements apply to all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The adoption of FIN 46 is not expected to have a significant impact on our financial position or results of operations.
2. Net (Loss) Per Share
We compute basic net income (loss) per common share by dividing net income (loss) applicable to common stockholders by the weighted average of common shares outstanding during the period. We compute diluted net income (loss) per share using the weighted average of all potential shares of common stock outstanding during the period. We excluded all stock options and warrants from the calculation of diluted loss per common share for the three
7
month periods ended March 31, 2003 and 2002, because these securities were anti-dilutive during these periods.
3. Comprehensive Loss
During the three months ended March 31, 2003, total comprehensive loss amounted to $5.6 million, compared to a total comprehensive loss of $6.0 million for the comparable period in 2002. The components of comprehensive loss for the three month periods ended March 31, 2003 and March 31, 2002 are as follows (in thousands):
| Three months ended | ||||||||
| March 31, | ||||||||
| 2003 | 2002 | |||||||
Net loss |
$ | (5,381 | ) | $ | (3,168 | ) | ||
Foreign currency translation adjustment |
38 | 25 | ||||||
Change in unrealized gain (loss) on
securities, net of reclassification
adjustments for realized gain (loss) |
(224 | ) | (2,899 | ) | ||||
Comprehensive loss |
$ | (5,567 | ) | $ | (6,042 | ) | ||
4. Goodwill and Other Intangible Assets
There were no changes in the carrying amount of goodwill during the three months ended March 31, 2003.
The components of our other intangible assets at March 31, 2003, are as follows (in thousands):
| Gross Carrying | Accumulated | |||||||||||
| Amount | Amortization | Net | ||||||||||
Existing technology |
$ | 6,810 | $ | (1,333 | ) | $ | 5,477 | |||||
Patents |
1,310 | (313 | ) | 997 | ||||||||
Total |
$ | 8,120 | $ | (1,646 | ) | $ | 6,474 | |||||
Amortization expense for our other intangible assets was $201,000 and $205,000 for the three months ended March 31, 2003 and 2002, respectively.
The expected future amortization expense of our other intangible assets is as follows (in thousands):
| Amortization Expense | ||||
For
the three month period ended March 31, 2003 |
$ | 201 | ||
Remaining nine months in 2003 |
604 | |||
Total for the year ending December 31, 2003 |
$ | 805 | ||
For the year ending December 31, 2004 |
$ | 805 | ||
For the year ending December 31, 2005 |
$ | 805 | ||
For the year ending December 31, 2006 |
$ | 805 | ||
For the year ending December 31, 2007 |
$ | 805 | ||
For the year ending December 31, 2008 |
$ | 805 | ||
Thereafter |
$ | 1,845 | ||
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5. License for Liquipatch
In June 2001, we entered into a global licensing agreement with Novartis Consumer Health SA for the Liquipatch drug-delivery system for use in topical antifungal applications. The agreement gives Novartis the exclusive, worldwide rights to use the Liquipatch technology in the topical antifungal field. In March 2002, Novartis exercised its then-existing option to expand the license agreement. Novartis will be responsible for all development costs, and will be obligated to pay license fees, milestone payments and royalties on future product sales. We recognized contract revenue related to this agreement of $3,000 and $580,000 in the quarters ended March 31, 2003 and 2002, respectively.
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