SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One) | ||
x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended March 31, 2003 | ||
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 000-22171
KOS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
FLORIDA | 65-0670898 | |
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(State or Other Jurisdiction of | (I.R.S. Employer | |
Incorporation or Organization) | Identification No.) |
1001 BRICKELL BAY DRIVE, 25th FLOOR, MIAMI, FLORIDA 33131
(Address of Principal Executive Offices, Zip Code)
Registrants Telephone Number, Including Area Code: (305) 577-3464
Indicate 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 þ No o
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS:
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes o No o
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date:
Class | Outstanding at May 8, 2003 | |
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Common Stock, par value $.01 per share | 20,959,010 |
KOS PHARMACEUTICALS, INC.
INDEX
Page | ||||||
PART I FINANCIAL INFORMATION |
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Item 1 Condensed Consolidated Financial Statements |
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Condensed Consolidated Balance Sheets as of March 31, 2003 (unaudited) and December 31, 2002 | 2 | |||||
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Condensed Consolidated Statements of Operations for the three months ended March 31, 2003 (unaudited) and 2002 (unaudited) | 3 | |||||
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Condensed Consolidated Statement of Shareholders Deficit for the three months ended March 31, 2003 (unaudited) | 4 | |||||
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Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2003 (unaudited) and 2002 (unaudited) | 5 | |||||
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Notes to Condensed Consolidated Financial Statements (unaudited) | 6 | |||||
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Item 2 Managements Discussion and Analysis of Financial
Condition and Results of Operations |
12 | |||||
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Item 3 Quantitative and Qualitative Disclosures about Market Risk |
21 | |||||
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Item 4 Controls and Procedures |
21 | |||||
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PART II OTHER INFORMATION |
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Item 1 Legal Proceedings |
22 | |||||
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Item 6 Exhibits and Reports on Form 8-K |
24 |
PART I FINANCIAL INFORMATION
Item 1 Condensed Consolidated Financial Statements
KOS PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, | December 31, | |||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
ASSETS |
||||||||||
Current Assets: |
||||||||||
Cash and cash equivalents |
$ | 26,020 | $ | 19,572 | ||||||
Trade accounts receivable, net |
26,955 | 24,088 | ||||||||
Inventories |
6,620 | 5,927 | ||||||||
Prepaid expenses and other current assets |
3,818 | 5,894 | ||||||||
Total current assets |
63,413 | 55,481 | ||||||||
Fixed Assets, net |
12,627 | 12,528 | ||||||||
Other Assets |
2,469 | 1,432 | ||||||||
Total assets |
$ | 78,509 | $ | 69,441 | ||||||
LIABILITIES AND SHAREHOLDERS
DEFICIT |
||||||||||
Current Liabilities: |
||||||||||
Accounts payable |
$ | 6,258 | $ | 7,187 | ||||||
Accrued expenses |
37,664 | 34,549 | ||||||||
Advance payments from customers |
| 9,129 | ||||||||
Advance payment received on license agreement |
15,000 | 9,203 | ||||||||
Current portion of Notes Payable to Shareholder |
50,000 | 50,000 | ||||||||
Current portion of capital lease obligations |
58 | 57 | ||||||||
Total current liabilities |
108,980 | 110,125 | ||||||||
Notes Payable to Shareholder, net of current portion |
30,000 | 34,000 | ||||||||
Capital Lease Obligations, net of current portion |
10 | 25 | ||||||||
Shareholders Deficit: |
||||||||||
Preferred stock, $.01 par value, 10,000,000 shares authorized,
none issued and outstanding |
| | ||||||||
Common stock, $.01 par value, 50,000,000 shares authorized,
20,921,952 and 20,807,859 shares issued and outstanding as of
March 31, 2003 (unaudited) and December 31, 2002, respectively |
209 | 208 | ||||||||
Additional paid-in capital |
220,641 | 219,138 | ||||||||
Restricted stock grant |
(620 | ) | (694 | ) | ||||||
Accumulated deficit |
(280,711) | ) | (293,361 | ) | ||||||
Total shareholders deficit |
(60,481 | ) | (74,709 | ) | ||||||
Total liabilities and shareholders deficit |
$ | 78,509 | $ | 69,441 | ||||||
The accompanying notes are an integral part of these financial statements.
2
KOS PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months | ||||||||||
Ended | ||||||||||
March 31, | ||||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
Revenues, net |
$ | 68,275 | $ | 33,886 | ||||||
Cost of sales |
4,242 | 3,629 | ||||||||
64,033 | 30,257 | |||||||||
Operating Expenses: |
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Research and development |
11,625 | 13,093 | ||||||||
Selling, general and administrative |
38,979 | 32,444 | ||||||||
Total operating expenses |
50,604 | 45,537 | ||||||||
Income (Loss) from operations |
13,429 | (15,280 | ) | |||||||
Other Expense (Income): |
||||||||||
Other income |
| 11 | ||||||||
Interest income, net |
(77 | ) | (80 | ) | ||||||
Interest expense-related party |
856 | 1,004 | ||||||||
Total other expense |
779 | 935 | ||||||||
Income (loss) before provision for income taxes |
12,650 | (16,215 | ) | |||||||
Provision for income taxes |
| | ||||||||
Net income (loss) |
$ | 12,650 | $ | (16,215 | ) | |||||
Basic earnings (loss) per share of Common Stock |
$ | 0.61 | $ | (0.79 | ) | |||||
Diluted earnings (loss) per share of Common Stock |
0.35 | (0.79 | ) | |||||||
Weighted average shares of Common Stock and
Common Stock equivalents outstanding: |
||||||||||
Basic |
20,803 | 20,461 | ||||||||
Diluted |
38,603 | 20,461 |
The accompanying notes are an integral part of these financial statements.
3
KOS PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS DEFICIT (Unaudited)
(in thousands)
Additional | ||||||||||||||||||||
Paid-in | Restricted | Accumulated | ||||||||||||||||||
Common Stock | Capital | Stock Grant | Deficit | Total | ||||||||||||||||
Balance at December 31, 2002 |
$ | 208 | $ | 219,138 | $ | (694 | ) | $ | (293,361 | ) | $ | (74,709 | ) | |||||||
Common Stock issued to employees
under Kos Savings Plan |
| 248 | | | 248 | |||||||||||||||
Issuance of Common Stock to employees
under Stock Purchase Plan |
1 | 1,004 | | | 1,005 | |||||||||||||||
Exercise of stock options |
| 198 | | | 198 | |||||||||||||||
Compensation expense on restricted
stock grant |
| | 74 | | 74 | |||||||||||||||
Compensation expense on Common Stock
warrants award |
| 53 | | | 53 | |||||||||||||||
Net income |
| | | 12,650 | 12,650 | |||||||||||||||
Balance at March 31, 2003 |
$ | 209 | $ | 220,641 | $ | (620 | ) | $ | (280,711 | ) | $ | (60,481 | ) | |||||||
The accompanying notes are an integral part of these financial statements.
4
KOS PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Three Months Ended | ||||||||||||
March 31, | ||||||||||||
2003 | 2002 | |||||||||||
(Unaudited) | ||||||||||||
Cash Flows from Operating Activities: |
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Net Income (Loss) |
$ | 12,650 | $ | (16,215 | ) | |||||||
Adjustments to reconcile net income (loss) to net cash
provided by (used in) operating activities- |
||||||||||||
Depreciation and amortization |
729 | 502 | ||||||||||
Provision for inventory obsolescence |
165 | 120 | ||||||||||
Common Stock issued to employees |
248 | | ||||||||||
Compensation expense on restricted stock grant |
74 | 74 | ||||||||||
Compensation expense on Common Stock warrants award |
53 | | ||||||||||
Changes in operating assets and liabilities: |
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Trade accounts receivable |
(2,867 | ) | (9,177 | ) | ||||||||
Inventories |
(858 | ) | 2,338 | |||||||||
Prepaid expenses and other current assets |
2,076 | 931 | ||||||||||
Other assets |
| 5 | ||||||||||
Accounts payable |
(929 | ) | (1,185 | ) | ||||||||
Accrued expenses |
3,115 | 2,103 | ||||||||||
Advance payments from customers |
(9,129 | ) | 2,555 | |||||||||
Advance
payments received on license agreement |
5,797 | | ||||||||||
Net cash provided by (used in) operating activities |
11,124 | (17,949 | ) | |||||||||
Cash Flows from Investing Activities: |
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Capital expenditures and deposits on fixed assets to be acquired |
(1,865 | ) | (2,638 | ) | ||||||||
Net cash used in investing activities |
(1,865 | ) | (2,638 | ) | ||||||||
Cash Flows from Financing Activities: |
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Proceeds from issuance of Common Stock to employees
under Stock Purchase Plan |
1,005 | 712 | ||||||||||
Net proceeds from exercise of stock options |
198 | 426 | ||||||||||
Payment of Notes Payable to Shareholder |
(4,000 | ) | (25,000 | ) | ||||||||
Payments under capital lease obligations |
(14 | ) | (13 | ) | ||||||||
Net cash used in financing activities |
(2,811 | ) | (23,875 | ) | ||||||||
Net increase (decrease) in cash and cash equivalents |
6,448 | (44,462 | ) | |||||||||
Cash and Cash Equivalents, beginning of period |
19,572 | 45,319 | ||||||||||
Cash and Cash Equivalents, end of period |
$ | 26,020 | $ | 857 | ||||||||
Supplemental Disclosure of Cash Flow Information: |
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Interest paid |
$ | 856 | $ | 1,004 |
The accompanying notes are an integral part of these financial statements.
5
KOS PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. General
The condensed consolidated financial statements included herein have been prepared by Kos Pharmaceuticals, Inc. (the Company or Kos) without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The results of operations and cash flows for the three-month period ended March 31, 2003, are not necessarily indicative of the results of operations or cash flows that may be reported for the year ending December 31, 2003. The unaudited condensed consolidated financial statements included herein should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Companys Form 10-K for the year ended December 31, 2002.
2. Recent Accounting Pronouncements
In June 2001, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 143, Accounting for Asset Retirement Obligations (SFAS 143). SFAS 143 addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs and is effective for financial statements issued for fiscal years beginning after June 15, 2002. The Company adopted SFAS 143 on January 1, 2003. The adoption of SFAS 143 did not have a material impact on the Companys financial position or results of operations.
In April 2002, the FASB issued SFAS 145, Rescission of FASB Statements No. 4, 44 and 64, Amendment of SFAS 13, and Technical Corrections (SFAS 145). SFAS 145 rescinds previous accounting guidance, which required all gains and losses from extinguishment of debt be classified as an extraordinary item. Under SFAS 145 classification of debt extinguishment depends on the facts and circumstances of the transaction. SFAS 145 is effective for fiscal years beginning after May 15, 2002. The Company adopted SFAS 145 on January 1, 2003. The adoption of SFAS 145 did not have a material impact on the Companys financial position or results of operations.
In July 2002, the FASB issued SFAS 146, Accounting for Costs Associated
with Exit or Disposal Activities (SFAS 146). SFAS 146 addresses financial
accounting and reporting for costs associated with exit or disposal activities
and nullifies the Emerging Issues Task Force Issue No. 94-3, Liability
Recognition for Certain Employee Termination Benefits and Other Costs to Exit
an Activity including Certain Costs Incurred in a Restructuring, (Issue
94-3). The principal difference between Statement 146 and Issue 94-3 relates
to SFAS 146 requirements for recognition of a liability for a cost associated
with an exit or disposal activity. Statement 146 requires that a liability for
a cost associated with an exit or disposal activity be recognized when the
liability is incurred. Under Issue 94-3, a liability for an exit cost was
recognized at the date of an entitys commitment to an exit plan. A
fundamental conclusion reached by the FASB in this Statement is that an
entitys commitment to a plan, by itself, does not create an obligation that
meets the definition of a liability. Therefore, this Statement eliminates the
definition and requirements for recognition of exit costs in Issue 94-3. This
Statement also establishes that fair value is the objective for initial measurement
of the liability. SFAS 146 is effective for exit or disposal activities that
are initiated after December 31, 2002. The Company adopted SFAS 146 on January
1,
6
Table of Contents
2003. The adoption of SFAS 146 did not have a material impact on the Companys financial position or results of operations.
In November 2002, the FASB issued Interpretation No. 45, Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN No. 45). The interpretation elaborates on the existing disclosure requirements for most guarantees, including loan guarantees such as standby letters of credit. It also clarifies that at the time a company issues a guarantee, the company must recognize an initial liability for the fair value, or market value, of the obligations it assumes under the guarantee and must disclose that information in its interim and annual financial statements. The provisions related to recognizing a liability at inception of the guarantee for the fair value of the guarantors obligations does not apply to product warranties or to guarantees accounted for as derivatives. The initial recognition and initial measurement provisions apply on a prospective basis to guarantees issued or modified after December 31, 2002. The disclosure requirements are effective for financial statements of periods ending after December 15, 2002. The Company adopted the disclosure provisions of FIN No. 45 in 2002 and the recognition and measurement provisions on January 1, 2003. The adoption of FIN No. 45 did not have a material impact on the Companys financial position or results of operations.
In January 2003, the FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities (FIN No. 46), to expand upon and strengthen existing accounting guidance that addresses when a company should include in its financial statements the assets, liabilities and activities of another entity. Until now, one company generally has included another entity in its consolidated financial statements only if it controlled the entity through voting interests. FIN No. 46 changes that by requiring a variable interest entity, as defined, to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entitys activities or entitled to receive a majority of the entitys residual returns or both. FIN No. 46 also requires disclosures about variable interest entities that the company is not required to consolidate but in which it has a significant variable interest. The consolidation requirements of FIN No. 46 apply immediately to variable interest entities created after January 31, 2003 and to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply in all financial statements issued after January 31, 2003, regardless of when the variable interest entity was established. The adoption of FIN No. 46 did not have a material impact on the Companys financial position or results of operations.
3. Reporting of Comprehensive Income or Loss
SFAS No. 130 Reporting Comprehensive Income, establishes standards of reporting and display of comprehensive income and its components in a full set of financial statements. Comprehensive income or loss refers to revenues, expenses, gains and losses that are not included in net income or loss but rather are recorded directly in stockholders equity, such as certain unrealized gain or loss items. The Companys reported net income and loss equals comprehensive income and loss for all periods presented.
4. Income Taxes
The Company follows SFAS No. 109, Accounting for Income Taxes, which
requires, among other things, recognition of future tax benefits measured at
enacted rates attributable to deductible temporary differences between
financial statement and income tax bases of assets and liabilities and to tax
net operating loss carryforwards to the extent that realization of said
benefits is more likely than not. The net operating loss carryforwards
attributable to a predecessor of the Company, amounting to
approximately $51 million, were not transferred to the Company. As of
March 31, 2003, the Company had available approximately $225 million in net
operating loss carryforwards to offset future taxable net income, if any. Due
to the uncertainty of the Companys ability to generate sufficient taxable
income in the future to utilize such loss carryforwards, the net deferred tax
asset has been fully reserved. There
7
was no provision for income taxes for the three months ended March 31, 2003 due to the
Companys net operating loss carryforwards.
5. Net Income (Loss) Per Share
Basic earnings (loss) per share is determined by dividing the Companys
net income (loss) by the weighted average number of shares of Common Stock
outstanding. Diluted income (loss) per share also includes dilutive Common
Stock equivalents outstanding after applying the treasury stock method. A
reconciliation of the denominator of the basic and diluted earnings per share
computation is as follows:
Table of Contents
March 31, | |||||||||
2003 | 2002 | ||||||||
(in thousands) | |||||||||
Basic weighted average number of
shares outstanding |
20,803 | 20,461 | |||||||
Effect of dilutive securities: |
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Stock options |
1,617 | | |||||||
Non-detachable warrants (See Note 9) |
6,000 | | |||||||
Convertible debt (See Note 9) |
10,183 | | |||||||
Diluted weighted average number of
shares outstanding |
38,603 | 20,461 | |||||||
The following Common Stock equivalents have been excluded from the calculation of weighted average shares outstanding because their impact is antidilutive:
March 31, | |||||||||
2003 | 2002 | ||||||||
(in thousands) | |||||||||
Stock options |
| 6,348 | |||||||
Non-detachable warrants (See Note 9) |
| 6,000 | |||||||
Convertible debt (See Note 9) |
| 10,183 | |||||||
Total |
| 22,531 | |||||||
6. Inventories
Inventories consist of the following:
March 31, | December 31, | ||||||||
2003 | 2002 | ||||||||
(in thousands) | |||||||||
Raw materials |
$ | 1,249 | $ | 1,433 | |||||
Work in process |
2,448 | 1,619 | |||||||
Finished goods |
2,923 | 2,875 | |||||||
Total inventories |
$ | 6,620 | $ | 5,927 | |||||
7. Accounting for Product Returns Impact on Revenue Recognition
The Company periodically evaluates the volume of its Niaspan and Advicor products that are in customer inventories or elsewhere in the distribution channel to determine whether increased risk of product returns exists. For the period from the introduction of its products through December 31, 2002, Kos return risk expectations were consistently based on its limited product return experience given the early stage nature of its products and of the Company. Accordingly, Kos established a specific return risk estimate based on estimated inventory levels in the distribution channel that was used to determine the amount of revenue that could be recorded during a given period. During the quarter ended March 31, 2003, as a result of the significant history of minimal returns for both products since their introduction, Kos revised its return risk estimates to reflect the historically low product return patterns.
8
This change in accounting estimate has resulted in the Company recognizing as revenue all product shipments made during the quarter ended March 31, 2003, as well as $11.1 million of its prior period product shipments not previously recognized as revenue because of its previous product return risk exposure estimates. The impact of this change in estimate increased the Companys reported revenues, net income, and basic and diluted earnings per share by $11.1 million, $9.9 million, and $0.48 per share and $0.26 per share, respectively, for the quarter ended March 31, 2003.
8. Advance Payments Received on License Agreement
On October 23, 2002, the Company signed an exclusive international commercialization agreement with Merck KGaA (Merck) to market the Niaspan and Advicor products outside the United States, Canada and Japan. Under terms of the agreement, Merck will provide Kos up to $61 million in licensing, milestone and reimbursement payments, including $15 million of upfront payments, of which $12.5 million are reimbursable by Kos if it fails to achieve certain regulatory milestones. The milestone payments are dependent on the achievement of certain regulatory approvals and sales thresholds. Kos will also receive 25% of net sales of the products in the territory, which includes the cost of goods sold. Merck will be responsible for conducting Phase IV clinical studies and commercialization activities while Kos is responsible for obtaining initial marketing authorization in all major European countries and the supply and manufacturing of the products. Through March 31, 2003, Kos has received $15 million in upfront and reimbursement payments from Merck. The majority of these payments will be recognized as revenue in future periods upon Kos achieving certain regulatory milestones.
9. Notes Payable to Shareholder
On December 19, 2002, the Company and Michael Jaharis, Chairman Emeritus of the Companys Board of Directors and its principal shareholder, entered into an agreement whereby Mr. Jaharis agreed to replace the previous $30-million credit facility extended to the Company by Mr. Jaharis on July 1, 1998 (which was to expire on December 31, 2002), with a new facility expiring on June 30, 2008 (the Additional Standby Facility). In connection with this new credit arrangement, the Company granted to Mr. Jaharis non-detachable warrants to purchase 1,000,000 shares of the Companys Common Stock at an exercise price based on the market price of the Companys Common Stock on the date that the first draw under this facility occurs. The Company had no borrowings outstanding under the Additional Standby Facility as of March 31, 2003. Borrowings, when outstanding, will bear interest at the prime rate (4.25% as of March 31, 2003), and are subject to the terms and conditions of borrowings made under the Supplemental Credit Facility.
On September 1, 1999, the Company formally agreed to the terms of an additional $50-million funding arrangement initially entered into with Michael Jaharis on October 7, 1998 (the Supplemental Credit Facility). On July 21, 2001, the Company replaced its existing $50 million promissory note payable to Mr. Jaharis with two, $25 million, promissory notes, one payable in the name of Mr. Jaharis and the other payable in the name of Mr. Jaharis wife. With this promissory note replacement, all of Mr. Jaharis existing rights and obligations under the Supplemental Credit Facility, with respect to one-half of
9
the outstanding amount, have been transferred to Mrs. Jaharis, and subsequently to her transferee. All other terms and conditions of the Supplemental Credit Facility remain unchanged. Borrowings under the Supplemental Credit Facility totaled $50 million as of March 31, 2003, bear interest at the prime rate, are convertible (at $4.91 per share) into shares of the Companys Common Stock, and will be due December 31, 2003. The Company believes that on or prior to the maturity date, it will have sufficient cash, available credit, and access to capital from third parties to be able to repay the Supplemental Credit Facility on a timely basis in the event that it is not converted into shares of the Companys Common Stock. However, the Company believes that, if the market price of the Companys Common Stock continues to significantly exceed the conversion price established under the Supplemental Credit Facility, which is $4.91 per share, through the maturity date, Mr. Jaharis and the other lenders will elect to convert the borrowings outstanding under this facility into shares of Kos Common Stock prior to the maturity date, thereby relieving the Company of the obligation to repay such facility. If such debt conversion were not to take place for any reason, the Company would be required to utilize its cash flow from operations and its then remaining borrowing capacity under its two other facilities with Mr. Jaharis, if such borrowing capacity is available at all, to repay borrowings due under the Supplemental Credit Facility. In addition, the Company could also be required to seek to raise additional capital to repay the Supplemental Credit Facility to the extent that its cash and available credit are insufficient to repay the Supplemental Credit Facility in full prior to its maturity date. The Companys decision to issue additional debt or equity, or to sell some or all of its assets, in order generate additional capital would require the consent of Mr. Jaharis and the other lenders. It is possible that the Company could seek to extend the maturity date of the Supplemental Credit Facility or enter into a new financing arrangement with Mr. Jaharis and the other lenders that would replace the Supplemental Credit Facility; however, the Company has not sought any such extension or replacement facility and Mr. Jaharis and the other lenders would be under no obligation to the Company to provide any such extension or replacement. There can be no assurance that additional capital will be available to the Company on acceptable terms, or at all, or that the lenders under the Supplemental Credit Facility will convert the Companys borrowings under such facility into shares of the Companys Common Stock.
On December 21, 1999, Mr. Jaharis agreed to extend another $50-million loan to the Company (the Standby Facility). Borrowings made under the Standby Facility totaled $30 million as of March 31, 2003, are due June 20, 2005, and are also subject to most of the terms and conditions of borrowings made under the Supplemental Credit Facility, including the condition that the death of lender shall not have occurred. Borrowings made under the Standby Facility are not, however, convertible into shares of the Companys Common Stock. In lieu of a conversion feature, the Company granted to Mr. Jaharis non-detachable warrants to purchase up to 6,000,000 shares of the Companys Common Stock at $5.00 per share, which approximates the market value of the Companys Common Stock on the effective date of this Standby Facility. The warrants are exercisable at any time until June 30, 2006.
The Company recorded $0.9 million and $1.0 million of interest expense for the three months ended March 31, 2003 and 2002, respectively, related to its credit facilities with Mr. Jaharis and his transferees.
10
10. Compensation Cost for Stock Options Issued to Employees
As permitted by SFAS No. 148, Accounting for Stock-Based Compensation (SFAS 148), which amended SFAS No. 123, Accounting for Stock-Based Compensation, the Company accounts for options issued to employees and to outside directors (after June 30, 2000) under Accounting Principles Board Opinion No. 25 Accounting for Stock Issued to Employees. Consequently, no compensation cost has been recognized on options issued to employees because the exercise price of such options was not less than the market value of the Common Stock on the date of grant. Had compensation cost for options issued to employees been determined consistent with SFAS 148, the Companys net income (loss) and net income (loss) per share would have been the Pro Forma amounts shown in the following table:
Three Months | |||||||||||
Ended | |||||||||||
March 31, | |||||||||||
2003 | 2002 | ||||||||||
(in thousands, except | |||||||||||
per share data) | |||||||||||
Net income (loss): |
|||||||||||
As reported |
$ | 12,650 | $ | (16,215 | ) | ||||||
Stock-based employee compensation
expense under fair value method |
4,665 | 3,182 | |||||||||
Pro forma |
$ | 7,985 | $ | (19,397 | ) | ||||||
Net income (loss) per share: |
|||||||||||
As reported: |
|||||||||||
Basic |
$ | 0.61 | $ | (0.79 | ) | ||||||
Diluted |
0.35 | (0.79 | ) | ||||||||
Pro forma: |
|||||||||||
Basic |
$ | 0.38 | $ | (0.95 | ) | ||||||
Diluted |
0.23 | (0.95 | ) | ||||||||
Number of shares used in calculation: |
|||||||||||
Basic |
20,803 | 20,461 | |||||||||
Diluted |
38,603 | 20,461 |
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Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations
General
A predecessor corporation to the Company was formed in July 1988 under the name of Kos Pharmaceuticals, Inc. principally to conduct research and development on new formulations of existing prescription pharmaceutical products. In June 1993, Aeropharm Technology, Inc. (Aeropharm), a then majority-owned subsidiary of the Company, was formed to conduct research and development activities on aerosolized products, dispensed in metered-dosed inhalers, for the treatment of respiratory diseases. During June 1996, this predecessor corporation acquired the outstanding minority interest in Aeropharm; changed its name to Kos Holdings, Inc. (Holdings); established the Company as a wholly-owned subsidiary under the name of Kos Pharmaceuticals, Inc.; and, effective as of June 30, 1996, transferred all of its existing assets, liabilities, and intellectual property, other than certain net operating loss carryforwards, to the Company. Accordingly, all references in this Form 10-Q filing to the Companys business include the business and operations of Holdings until June 30, 1996.
On March 12, 1997, the Company completed an initial public offering (IPO) of its Common Stock. From inception through the IPO, the Company had not recorded any significant revenues; and the Company had funded its operations exclusively through equity contributions and a loan from its majority shareholder. Through March 31, 2003, the Company had accumulated a deficit from operations of approximately $281 million. In connection with the transfer of operations from Holdings to the Company on June 30, 1996, net operating loss carryforwards amounting to approximately $51.0 million and related tax benefits were retained by Holdings and not transferred to the Company. Consequently, the Company may utilize net operating losses sustained subsequent to June 30, 1996, amounting to approximately $225 million as of March 31, 2003, to offset future taxable net income, if any.
On July 28, 1997, the Company was granted clearance by the Food and Drug Administration (FDA) to market its lead product, Niaspan. The Company began shipping Niaspan to wholesalers in mid-August 1997 and began detailing Niaspan to physicians in September 1997. On December 17, 2001, the Company received approval from the FDA to market its Niaspan/lovastatin combination product, Advicor. The Company began marketing Advicor at the end of January 2002.
Results of Operations
Critical Accounting Policies
The Companys significant accounting policies are described in Note 2 to the consolidated financial statements included in Kos annual report on Form 10-K for the year ended December 31, 2002, filed with the SEC on March 26, 2003. The Company believes that its most critical accounting policies include revenue recognition and the estimation of product returns, rebates, and other allowances. The impact of these estimates on results of operations for the three months ended March 31, 2003 and 2002, are described below. The Companys management periodically reviews these policies and estimates, the effect of which is reflected as a component of net revenue in the period in which the change is known. Other than the change described below associated with the Companys estimate of its product return exposure, such changes to these estimates have not been material to the Companys results of operations during the three months ended March 31, 2003.
The Company periodically evaluates the volume of its Niaspan and Advicor products that are in customer inventories or elsewhere in the distribution channel to determine whether increased risk of product returns exists. For the period from the introduction of its products through December 31, 2002, Kos return risk expectations were consistently based on its limited product return experience given the early stage nature of its products and of the Company. Accordingly, Kos established a specific return risk estimate based on estimated inventory levels in the distribution channel that was used to determine the amount of revenue that could be recorded during a given period. During the quarter ended March 31, 2003, as a result of the significant history of minimal returns for both products since their introduction, Kos revised its return risk estimates to reflect the historically low product return patterns.
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This change in accounting estimate has resulted in the Company recognizing as revenue all product shipments made during the quarter ended March 31, 2003, as well as $11.1 million of its prior period product shipments not previously recognized as revenue because of its previous product return risk exposure estimates. The impact of this change in estimate increased the Companys reported revenues, net income, and basic and diluted earnings per share by $11.1 million, $9.9 million, and $0.48 per share and $0.26 per share, respectively, for the quarter ended March 31, 2003.
The Company will continue to monitor wholesaler inventory levels, and, if the Companys product return risk exceeds acceptable levels, the Company may be required to not recognize the revenue and related costs associated with the excess inventory until such return risk is mitigated.
Three Months Ended March 31, 2003 and 2002
The Companys reported revenue increased to $68.3 million for the three months ended March 31, 2003, from $33.9 million for 2002. This increase in revenue was mostly related to increases in prescription volume for the Companys Niaspan product during the 2003 period as compared to the 2002 period, to increases in prescription volume for the Companys Advicor product, which was launched during the first quarter of 2002, and to the change in product return estimates (as described above).
Gross profit (reported product sales less cost of product sold) for the three months ended March 31, 2003, was $64.0 million, compared with $30.3 million for the 2002 period.
On January 28, 2002 the Company began commercializing its Advicor product. Accordingly, results of operations for the three months ended March 31, 2003 and 2002, reflect the Companys significant efforts in connection with the commercial launch of this product.
On October 23, 2002, the Company signed an exclusive international commercialization agreement with Merck KGaA (Merck) to market the Niaspan and Advicor products outside the United States, Canada and Japan. Under terms of the agreement, Merck will provide Kos up to $61 million in licensing, milestone and reimbursement payments, including $15 million of upfront payments, of which $12.5 million are reimbursable by Kos if it fails to achieve certain regulatory milestones. The milestone payments are dependent on the achievement of certain regulatory approvals and sales thresholds. Kos will also receive 25% of net sales of the products in the territory, which includes the cost of goods sold. Merck will be responsible for conducting Phase IV clinical studies and commercialization activities while Kos is responsible for obtaining initial marketing authorization in all major European countries and the supply and manufacturing of the products. Through March 31, 2003, Kos has received $15 million in upfront and reimbursement payments from Merck. The majority of these payments will be recognized as revenue in future periods upon Kos achieving certain regulatory milestones.
The Companys research and development expenses decreased to $11.6 million for the three months ended March 31, 2003, from $13.1 million for the three months ended March 31, 2002. The decreased expenses related primarily to decreases of $1.4 million in clinical study costs resulting from the absence, during the 2003 period, of an Advicor clinical trial completed in mid-2002, of $0.8 million in formulation costs for products under development, and of $0.4 million in medical education costs which were greater during the 2002 period in support of the
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commercial launch of the Advicor product. These decreases in research and development expenses were partially offset by an increase of $1.1 million in personnel and personnel related costs.
Selling, general and administrative expenses increased to $39.0 million for the three months ended March 31, 2003, from $32.4 million for the three months ended March 31, 2002. Within this category, selling expenses increased to $32.4 million for the 2003 period from $28.5 million for the comparable 2002 period. The growth in selling expenses was primarily related to increases of $3.0 million in sales force operating costs in support of the Niaspan and Advicor products, and of $2.2 million in royalty expenses. The increase in selling expenses was partially offset by a decrease of $1.5 million in marketing costs which were also greater during the 2002 period in support of the commercial launch of the Advicor product. General and administrative expenses increased to $6.6 million for the three months ended March 31, 2003, from $3.9 million for the three months ended March 31, 2002. This increase in general and administrative expenses was primarily related to increases of $1.0 million in personnel and personnel related costs, of $0.6 million in professional fees, and of $1.1 million in other costs associated with the expanded activities of the Company.
The Company is subject to the terms of the December 19, 2002, $30 million credit facility (the Additional Standby Facility), and the December 21, 1999, $50 million credit facility (the Standby Facility), with Michael Jaharis, Chairman Emeritus of the Companys Board of Directors and its principal shareholder. The Company is also subject to the terms of the September 1, 1999, $50 million credit facility (the Supplemental Credit Facility) with Mr. Jaharis and with a transferee of Mr. Jaharis wife. Borrowings under these credit facilities totaled $80 million as of March 31, 2003, and bear interest at the prime rate (4.25% as of March 31, 2003). Interest expense under these credit facilities totaled $0.9 million and $1.0 million for the three months ended March 31, 2003 and 2002, respectively.
The Company recorded a net income of $12.7 million for the three months ended March 31, 2003, compared with a net loss of $16.2 million for the three months ended March 31, 2002.
Liquidity and Capital Resources
At March 31, 2003, the Company had cash and cash equivalents totaling $26.0 million (of which $17.1 million was pledged as collateral for the Companys letters of credit facility with a major institutional bank) and a working capital deficiency of $45.6 million. The Companys primary uses of cash to date have been to fund selling, general and administrative expenses, and research and development expenses, including clinical trials. As of March 31, 2003, the Companys investment in equipment and leasehold improvements, net of depreciation and amortization, was $12.6 million. During the three months ended March 31, 2003, the Company spent $1.9 million in capital expenditures and deposits on fixed assets to be acquired. The Company expects to spend about $6 million in capital expenditures during the remainder of the year ending December 31, 2003, primarily to provide increased production capacity and to support its expanded operational activities.
On December 19, 2002, the Company and Michael Jaharis, Chairman Emeritus of the Companys Board of Directors and its principal shareholder, entered into an agreement whereby Mr. Jaharis agreed to replace the previous $30-million credit facility extended to the Company by Mr. Jaharis on July 1, 1998 (which was to expire on December 31, 2002), with a new facility expiring on June 30, 2008 (the Additional Standby Facility). In connection with this new credit arrangement, the Company granted to Mr. Jaharis non-detachable warrants to purchase 1,000,000 shares of the Companys Common Stock at an exercise price based on the market price of the Companys Common Stock on the date that the first draw under this facility occurs. The Company had no borrowings outstanding under the Additional Standby Facility as of March 31, 2003. Borrowings, when outstanding, will bear interest at the prime rate (4.25% as of March 31, 2003), and are subject to the terms and conditions of borrowings made under the Supplemental Credit Facility.
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On September 1, 1999, the Company formally agreed to the terms of an additional $50-million funding arrangement initially entered into with Michael Jaharis on October 7, 1998 (the Supplemental Credit Facility). On July 21, 2001, the Company replaced its existing $50 million promissory note payable to Mr. Jaharis with two, $25 million, promissory notes, one payable in the name of Mr. Jaharis and the other payable in the name of Mr. Jaharis wife. With this promissory note replacement, all of Mr. Jaharis existing rights and obligations under the Supplemental Credit Facility, with respect to one-half of the outstanding amount, have been transferred to Mrs. Jaharis, and were subsequently transferred by Mrs. Jaharis to a limited partnership that she controls. All other terms and conditions of the Supplemental Credit Facility remain unchanged. Borrowings under the Supplemental Credit Facility totaled $50 million as of March 31, 2003, bear interest at the prime rate, are convertible (at $4.91 per share) into shares of the Companys Common Stock, and will be due December 31, 2003. Although no amounts borrowed under the Supplemental Credit Facility have been converted as of March 31, 2003, the conversion of amounts borrowed under the Supplemental Credit Facility into shares of the Companys Common Stock would have resulted in the issuance of 10,183,299 additional shares of the Companys Common Stock, thus causing material dilution to existing shareholders of the Company. The Company believes that on or prior to the maturity date, it will have sufficient cash, available credit, and access to capital from third parties to be able to repay the Supplemental Credit Facility on a timely basis in the event that it is not converted into shares of the Companys Common Stock. However, the Company believes that, if the market price of the Companys Common Stock continues to significantly exceed the conversion price established under the Supplemental Credit Facility, which is $4.91 per share, through the maturity date, Mr. Jaharis and the other lenders will elect to convert the borrowings outstanding under this facility into shares of Kos Common Stock prior to the maturity date, thereby relieving the Company of the obligation to repay such facility. If such debt conversion were not to take place for any reason, the Company would be required to utilize its cash flow from operations and its then remaining borrowing capacity under its two other facilities with Mr. Jaharis, if such borrowing capacity is available at all, to repay borrowings due under the Supplemental Credit Facility. In addition, the Company could also be required to seek to raise additional capital to repay the Supplemental Credit Facility to the extent that its cash and available credit are insufficient to repay the Supplemental Credit Facility in full prior to its maturity date. The Companys decision to issue additional debt or equity, or to sell some or all of its assets, in order generate additional capital would require the consent of Mr. Jaharis and the other lenders. It is possible that the Company could seek to extend the maturity date of the Supplemental Credit Facility or enter into a new financing arrangement with Mr. Jaharis and the other lenders that would replace the Supplemental Credit Facility; however, the Company has not sought any such extension or replacement facility and Mr. Jaharis and the other lenders would be under no obligation to the Company to provide any such extension or replacement. There can be no assurance that additional capital will be available to the Company on acceptable terms, or at all, or that the lenders under the Supplemental Credit Facility will convert the Companys borrowings under such facility into shares of the Companys Common Stock.
On December 21, 1999, Mr. Jaharis agreed to extend another $50-million loan to the Company (the Standby Facility). Borrowings made under the Standby Facility totaled $30 million as of March 31, 2003, are due June 30, 2005, and are also subject to most of the terms and conditions of borrowings made under the Supplemental Credit Facility, including the condition that the death of lender shall not have occurred. Borrowings made under the Standby Facility are not, however, convertible into shares of the Companys Common Stock. In lieu of a conversion feature, the Company has granted to Mr. Jaharis non-detachable warrants to purchase 6,000,000 shares of the Companys Common Stock at $5.00 per share, which approximated the market value of the Companys Common Stock on the effective date of the Standby Facility. The warrants are exercisable at any time until June 30, 2006. The exercise of a significant number of the warrants issued under the Standby Facility will cause material dilution to existing shareholders of the Company.
The Company recorded $0.9 million and $1.0 million of interest expense for the three months ended March 31, 2003 and 2002, respectively, related to its credit facilities with Mr. Jaharis and his transferees.
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In January 2002, the Securities and Exchange Commission declared effective a shelf registration statement filed by the Company for the sale, from time to time, of up to $200 million of its Common Stock, Preferred Stock, stock options, warrants and other rights to purchase Common Stock or Preferred Stock. Proceeds from any offerings are expected to be used to fund expanded selling efforts for the Companys Niaspan and Advicor products, and for research and development and general corporate purposes. At March 31, 2003, the Company had not issued any securities under this registration statement.
Although the Company currently anticipates that, including the capital available to the Company under the Additional Standby Facility, the Supplemental Credit Facility, and the Standby Facility, it has or has access to an amount of working capital that will be sufficient to fund the Companys operations for the next twelve months, the Companys cash requirements during this period will be substantial and may exceed the amount of working capital available to the Company. The Companys ability to fund its operating requirements and maintain an adequate level of working capital will depend primarily on its ability to continue to generate substantial growth in sales of its Niaspan and Advicor products, its ability to continue to access its credit facilities, and on its ability to control operating expenses. The Companys failure to generate substantial growth in the sales of Niaspan and Advicor, control operating expenses, or meet the conditions necessary for the Company to obtain funding under the Additional Standby Facility, the Supplemental Credit Facility, and the Standby Facility, and other events including the progress of the Companys research and development programs; the costs and timing of seeking regulatory approvals of the Companys products under development; the Companys ability to obtain regulatory approvals in the United States and abroad; the Companys ability to manufacture products at an economically feasible cost; costs in filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights; the extent and terms of any collaborative research, manufacturing, marketing, joint venture, or other arrangements; and changes in economic, regulatory, or competitive conditions or the Companys planned business could cause the Company to require additional capital. In the event that the Company must raise additional capital to fund its working capital needs, it may seek to raise such capital through loans or the issuance of debt securities that would require the consent of the Companys current lender, or through the issuance of equity securities. To the extent the Company raises additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution to existing shareholders will result, and future investors may be granted rights superior to those of existing shareholders. Moreover, additional capital may not be available to the Company on acceptable terms, or at all.
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FORWARD-LOOKING INFORMATION: CERTAIN CAUTIONARY STATEMENTS
Statements contained in this Managements Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this report may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements present the Companys expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They frequently are accompanied by words such as anticipate, estimate, expect, project, intend, plan, believe, and other words and terms of similar meaning. In particular, these include statements relating to the Companys ability to: increase the size of its sales force and the amount of the sales of its products; successfully develop and commercialize new products under development and within expected timeframes; continue its strong financial performance and that of its products; increase its stock price; protect the strength of its patents; commercialize its products outside the United States and the success of its relationship with Merck KGaA; achieve its goals for future sales levels, operating margins, earnings growth, and shareholder value; have sufficient cash, available credit, and access to capital from third parties to be able to repay the Supplemental Credit Facility on a timely basis in the event that it is not converted into shares of the Companys Common Stock; meet the conditions necessary to obtain funding under its funding arrangements; and meet its expectations regarding future capital needs. These forward-looking statements are subject to risks and uncertainties which may cause actual results to differ materially from those projected in a forward-looking statement. Further, certain forward-looking statements are based upon assumptions of future events, which may not prove to be accurate. Subsequent written and oral forward looking-statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth below and elsewhere in this report and in other reports filed by the Company with the Securities and Exchange Commission.
Market Acceptance and Sales Growth of Niaspan and Advicor
The Companys success depends primarily upon its ability to successfully market and sell increasing quantities of the Niaspan and Advicor products. The Companys ability to successfully sell increasing quantities of the Niaspan and Advicor products will depend significantly on the continued acceptance of the Niaspan product by physicians and their patients despite the introduction of Advicor. As a consequence of the on-going commercialization of the Advicor product, which is a combination product including Niaspan and a statin, prescription levels for Niaspan may be adversely affected to the extent a significant number of physicians prescribe Advicor as a substitute product for their patients who are currently taking Niaspan. Such substitution could have an adverse effect on the growth of the combined revenue generated from the sale of the Companys products. The Company believes that intolerable flushing and potential liver toxicity associated with other currently available formulations of niacin are the principal reasons why physicians generally have been reluctant to prescribe or recommend such formulations. Flushing episodes are often characterized by facial redness, tingling or rash, and are a side effect that often occurs when humans ingest niacin. Currently available formulations of niacin generally either require, in the case of immediate-release niacin, the patient to take niacin several times per day, resulting in multiple flushing episodes, or result, in the case of sustained-release niacin, in liver toxicity. Although most patients taking the Niaspan and Advicor products will sometimes flush, the formulation and dosing regimen for Niaspan and Advicor have been designed to maximize patient acceptance and minimize the occurrence of flushing and liver toxicity. If, however, a significant number of patients using the Niaspan and Advicor products were to suffer episodes of flushing that they consider intolerable or to suffer other side effects, physicians may discontinue prescribing the Niaspan and Advicor products or patients may stop taking Niaspan and Advicor, which would have a material adverse effect on the Company. Unanticipated side effects or unfavorable publicity concerning the Niaspan or Advicor products or any other product incorporating technology similar to that used in the Niaspan or Advicor products also could have an adverse effect on the Companys ability to obtain regulatory approvals or to achieve acceptance by prescribing physicians, managed care providers, or patients, any of which would have a material adverse effect on the Company.
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On January 28, 2002, the Company began commercializing the Advicor product. The Companys ability to successfully sell increasing quantities of the Advicor product will depend significantly on the increasing acceptance of the Advicor product by physicians and their patients. If a significant number of patients using the Advicor product were to suffer episodes of flushing that they consider intolerable or to suffer more serious side effects, such as rhabdomyolysis or myopathy, physicians may discontinue prescribing the Advicor product or patients may stop taking Advicor, which would have a material adverse effect on the Company. Rhabdomyolysis is a rare disease in which serious muscle damage results in release of muscle cell contents into the bloodstream, which may be fatal. Myopathy is a disorder of muscle tissue or muscles that can result from endocrine disorders, metabolic disorders, infection or inflammation of the muscles, and from certain drugs. The Company is not aware of any reported cases of rhabdomyolysis or myopathy that were determined to be caused by patients taking Advicor, although there have been several cases where Niaspan (one of the principal ingredients in Advicor) or Advicor have been identified as possible causes of myopathy. Unanticipated side effects or unfavorable publicity concerning the Advicor product or any other product incorporating technology similar to that used in the Advicor product also could have an adverse effect on the Companys ability to maintain regulatory approvals or to achieve acceptance by prescribing physicians, managed care providers, or patients, any of which would have a material adverse effect on the Company.
In addition, Advicor may prove to be difficult to successfully sell because the cholesterol market is dominated by competitors with significantly larger sales forces and with significantly greater marketing resources than those available to the Company. Further, Advicor is a combination of two well-known cholesterol drugs, niacin and lovastatin, that have been available for a significant period of time. Although the combination of these drugs is highly effective in improving all of the major components of cholesterol, it is possible that physicians may not prescribe Advicor because it is not as new as more recently introduced compounds, such as the potent statin products marketed by the Companys competitors. Also, because Advicor is a combination of two currently available drugs, Advicor has been approved by the FDA for the improvement of cholesterol disorders in patients who were not able to achieve desired cholesterol improvements by taking either Niaspan or lovastatin alone. Consequently, although such an approved treatment indication is standard for combination drugs such as Advicor, it is possible that physicians will not prescribe Advicor until they have first prescribed either Niaspan, lovastatin, or another statin alone and subsequently determined that their patients need Advicor to achieve desired cholesterol improvements. Similarly the Companys ability to successfully sell increasing quantities of the Advicor product may be adversely affected by the November 2002 release of Zetia, part of a new class of cholesterol-lowering agents, and by the possible 2003 release of Crestor, a new, highly powerful statin product. Zetia is being marketed by Merck/Schering-Plough Pharmaceuticals, which is a joint venture between Merck & Co., Inc. and Schering-Plough Corporation, and Crestor will be marketed by AstraZeneca. Merck/Schering-Plough Pharmaceuticals and AstraZeneca are both competitors with substantially greater resources than Kos. Zetia is part of a new class of cholesterol-lowering agents that inhibit the intestinal absorption of cholesterol. Crestor is a type of statin drug that is highly effective in reducing LDL cholesterol, but is less effective in modifying HDL cholesterol, triglycerides and other forms of cholesterol. The Companys future sales of Advicor may also be affected by the potential release of several other new combination statin drugs in the future. Further, there are nine versions of generic lovastatin, one of the components of Advicor, that have been launched into the cholesterol market, which could adversely affect demand for Advicor. Consequently, the Companys effort to sell increasing quantities of the Advicor product may be unsuccessful.
Patents and Trademarks; Interference
The Companys ability to commercialize any of its products under development will depend, in part, on the Companys or on its licensors ability to obtain patents, enforce those patents, preserve trade secrets, and operate without infringing on the proprietary rights of third parties. In addition, the patents that the Company has been issued or for which Kos has applied relating to Niaspan, Advicor and certain
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of the Companys products under development are based on, among other things, the extended-release nature of the niacin active ingredient. If the indications treated by Niaspan, Advicor and such other products under development could be treated using drugs without such extended-release properties, such patents and patent applications may not prevent the use of other niacin-based drugs for the treatment of such indications, which would have a material adverse effect on the Company. Further, the Company would be adversely affected if:
| The patent applications licensed to or owned by Kos do not result in issued patents; | ||
| Meaningful patent protection is not secured for any particular technology; or | ||
| Any patents that have been or may be issued to Kos or the Companys licensors, including the patents covering the Companys Niaspan product, are invalid or unenforceable. |
In general, the U.S. patents and patent applications owned by or licensed to Kos relate to certain extended-release niacin compositions and their methods of use. Protection of the chemical entity is not available for the active ingredient in Niaspan, or either of the active ingredients in Advicor. Moreover, the active ingredient in Niaspan, niacin, is currently sold in the United States and other markets for lipid altering and for other uses. The additional active ingredient in Advicor, lovastatin, is also currently sold in the United States and other markets for lipid altering. Even in jurisdictions where the use of the active ingredients in Niaspan and Advicor for lipid altering and other indications may be covered by the claims of method-of-use and composition patents owned by or licensed to Kos, off-label sales might occur that would be difficult to prevent through enforcement of Kos patents, especially if another company markets the active ingredient at a price that is less than the price of Niaspan or Advicor, thereby potentially reducing the sales of such products.
The U.S. Patent and Trademark Office (the PTO) has issued U.S. Patent numbers 6,129,930 and 6,080,428 to the Company with claims related to Niaspans composition and method-of-use. In addition, on June 18, 2002, the PTO issued U.S. Patent number 6,406,715 related to certain unique pharmacokinetic features of Kos inventive extended-release niacin compositions, including Niaspan and Advicor. On February 7, 1997, the Company entered into an agreement with a generic manufacturer pursuant to which the Company and the manufacturer granted cross-licenses to each other under their respective patents. The Company has purchased the patents that were the subject of the cross-license agreement and agreed to continue paying a royalty to the manufacturer on terms similar to those contained in the cross-license agreement.
The Company has received patents and has filed patent applications covering technologies pertaining to propellant-driven aerosol formulations that do not contain chlorofluorocarbons. The Company is aware that certain European and U.S. patents have been issued with claims covering products that contain certain propellant-driven aerosol formulations that do not contain chlorofluorocarbons. It may be argued that certain or all of the Companys aerosol products under development may use a formulation covered by such European or U.S. patents. If that is shown to be the case, the Company would be prevented from making, using or selling such products unless Kos obtains a license under such patents, which license may not be available on commercially reasonable terms, or at all, or unless such patents are determined to be invalid in Europe or invalid or unenforceable in the United States. The Companys development of products that may be covered by such patents and its failure to obtain licenses under such patents in the event such patents are determined to be valid and enforceable could have an adverse effect on the Companys business.
On January 23, 2002, the Company received notice from Barr Laboratories, Inc. (Barr) that it had filed with the FDA an Abbreviated New Drug Application (ANDA) that would allow Barr to market a generic version of the Companys 1000 mg Niaspan product. On May 12, 2003, Barr announced that it received tentative approval from the FDA for its generic version of the Companys 1000 mg Niaspan product. Under the patent laws of the United States, the filing of an ANDA for a pharmaceutical composition or method of use that is currently
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protected by a patent, such as Niaspan, constitutes an act of infringement. As a result, on March 4, 2002, the Company filed a patent infringement lawsuit against Barr in the Southern District of New York (SDNY). On March 11, 2002, the Company filed an amended complaint (the Amended Complaint). In this lawsuit, the Company asserts that Barr has infringed the 428 and 930 patents. Under the FDA statute, the filing of a patent infringement suit by the Company suspends the ANDA approval process for 30 months or until the infringement suit is resolved. On March 25, 2002, Barr answered the Amended Complaint by denying that the 428 and 930 patents are valid and infringed, and seeking a declaratory judgment to that effect. On August 19, 2002, Barr amended its answer to add counterclaims requesting a declaratory judgment that two other patents owned by Kos, U.S. patent number 5,126,145 and 5,268,181, are not infringed, and that the 181 patent is invalid.
On July 9, 2002, the Company received notice from Barr that it had filed an ANDA with the FDA that would, if approved, allow Barr to market generic versions of the Companys 500 mg and 750 mg Niaspan products. On August 13, 2002, the Company filed a second patent infringement lawsuit against Barr also in the SDNY. Again, the Company asserted that Barr has infringed the 428 and 930 patents. On September 3, 2002, Barr answered the complaint by denying infringement and alleging that the patents are invalid. Barr also sought a declaratory judgment that the 428, 930, 145, and 181 patents are not infringed, and that the 428, 930, and 181 patents are invalid. The two cases were consolidated on September 23, 2002.
On September 30, 2002, the Company received notice from Barr that it had filed a Supplemental Paragraph IV Certification relating to Kos 715 patent. The Company filed a third lawsuit on November 12, 2002, against Barr in the SDNY asserting infringement of this patent. On December 3, 2002, Barr answered the complaint by denying that the 715 patent is valid and infringed, and enforceable, and seeking a declaratory judgment of invalidity. Barr also sought a declaratory judgment that the 428, 930, 145, and 181 patents are not infringed, and that the 428, 930 and 181 patents are invalid. The third case was consolidated with the first two on January 23, 2003. On March 4, 2003, Kos replied to Barrs declaratory judgment counterclaims by denying that Kos patents are invalid or not infringed. Kos also sought a declaratory judgment that one or more of Barrs products will infringe the 145 and 181 patents.
Because the patent positions of pharmaceutical and biotechnology companies are highly uncertain and involve complex legal and factual questions, the patents owned and licensed by Kos, or any future patents, may not prevent other companies from developing competing products or ensure that others will not be issued patents that may prevent the sale of the Companys products or require licensing and the payment of significant fees or royalties. Furthermore, to the extent that (1) any of the Companys future products or methods are not patentable, (2) such products or methods infringe upon the patents of third parties, or (3) the Companys patents or future patents fail to give Kos an exclusive position in the subject matter to which those patents relate, the Company will be adversely affected. The Company may be unable to avoid infringement of third party patents and may have to obtain a license, or defend an infringement action and challenge the validity of the patents in court. A license may be unavailable on terms and conditions acceptable to the Company, if at all. Patent litigation is costly and time consuming, and the Company may be unable to prevail in any such patent litigation or devote sufficient resources to even pursue such litigation. If the Company does not obtain a license under such patents, or if it is found liable for infringement and if it is not able to have such patents declared invalid, the Company may be liable for significant money damages, may encounter significant delays in bringing products to market, or may be precluded from participating in the manufacture, use, or sale of products or methods of treatment requiring such licenses.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The Companys exposure to market risk is limited primarily to fluctuating interest rates associated with variable rate indebtedness that is subject to interest rate changes in the United States. The Company does not use, nor has it historically used, derivative financial instruments to manage or reduce market risk. At March 31, 2003, the Company had $80 million of variable rate indebtedness bearing interest at the prime rate (4.25% at March 31, 2003).
Item 4. Controls and Procedures.
Within 90 days prior to the date of this report, the Company evaluated the effectiveness of the design and operation of the Companys disclosure controls and procedures (as defined in Exchange Act Rule 13a-14(c)), under the supervision and with the participation of the Companys management, including the Companys Chief Executive Officer and Chief Financial Officer. Based upon such evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that there was no reasonably apparent deficiency in the Companys disclosure controls and procedures such that the controls and procedures should not be expected to operate effectively. The Company is not aware of any significant changes in the Companys internal controls or in other factors that could significantly affect those controls subsequent to the date of the most recent evaluation of such controls by the Company.
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PART II OTHER INFORMATION
Item 1 Legal Proceedings
On August 5, 1998, a purported class action lawsuit was filed in the United States District Court for the Northern District of Illinois, Eastern Division, against the Company, the members of the Companys Board of Directors, certain officers of Kos, and the underwriters of the Companys October 1997 offering of shares of Common Stock. In its complaint, the plaintiff asserts, on behalf of itself and a putative class of purchasers of the Companys Common Stock during the period from July 29, 1997, through November 13, 1997, claims under: (i) sections 11, 12(a)(2) and 15 of the Securities Act of 1933; (ii) sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder; and (iii) for common law fraud, negligent misrepresentation and breach of fiduciary duty. The claims in the lawsuit relate principally to certain statements made by the Company, or certain of its representatives, concerning the efficacy, safety, sales volume and commercial viability of the Niaspan product. The complaint sought unspecified damages and costs, including attorneys fees and costs and expenses. Upon Kos motion, the case was transferred to the United States District Court for the Southern District of Florida. The Company filed a motion to dismiss the complaint against the Company and the individual Kos defendants on January 7, 1999. On May 24, 1999, the United States District Court for the Southern District of Florida dismissed the lawsuit with prejudice. The plaintiffs filed an appeal on June 7, 1999, with the United States Circuit Court of Appeals for the 11th Circuit. On July 16, 2002, the 11th Circuit Court of Appeals affirmed the District Courts dismissal of the plaintiffs claims with prejudice. The plaintiffs petitioned the Court of Appeals for a rehearing of the appeal, which was denied by the Court of Appeals.
On January 23, 2002, the Company received notice from Barr Laboratories, Inc. (Barr) that it had filed with the FDA an ANDA that would allow Barr to market a generic version of the Companys 1000 mg Niaspan product. On May 12, 2003, Barr announced that it received tentative approval from the FDA for its generic version of the Companys 1000 mg Niaspan product. Under the patent laws of the United States, the filing of an ANDA for a pharmaceutical composition or method of use that is currently protected by a patent, such as Niaspan, constitutes an act of infringement. As a result, on March 4, 2002, the Company filed a patent infringement lawsuit against Barr in the Southern District of New York (SDNY). On March 11, 2002, the Company filed an amended complaint (the Amended Complaint). In this lawsuit, the Company asserts that Barr has infringed Kos 6,080,428 and 6,129,930 patents. Under the FDA statute, the filing of a patent infringement suit by the Company suspends the ANDA approval process for the earlier of 30 months or until the infringement suit is resolved. On March 25, 2002, Barr answered the Amended Complaint (the Answer) by denying that the 428 and 930 patents are valid and infringed, and seeking a declaratory judgment to that effect. On August 19, 2002, Barr amended its Answer to add counterclaims requesting a declaratory judgment that two other patents owned by Kos, U.S. patent number 5,126,145 and 5,268,181, are not infringed, and that the 181 patent is invalid.
On July 9, 2002, the Company received notice from Barr that it had filed an ANDA with the FDA that would, if approved, allow Barr to market generic versions of the Companys 500 mg and 750 mg Niaspan products. On August 13, 2002, the Company filed a second patent infringement lawsuit against Barr also in the SDNY. Again, the Company asserted that Barr has infringed the 428 and 930 patents. On September 3, 2002, Barr answered the complaint by denying infringement and alleging that the patents are invalid. Barr also sought a declaratory judgment that the 428, 930, 145, and 181 patents are not infringed, and that the 428, 930, and 181 patents are invalid. The two cases were consolidated on September 23, 2002.
On September 30, 2002, the Company received notice from Barr that it had filed a Supplemental Paragraph IV Certification relating to Kos 6,406,715 patent. The Company filed a third lawsuit on November 12, 2002, against Barr in the SDNY asserting infringement of this patent. On December 3, 2002, Barr answered the complaint by denying that the 715 patent is valid and infringed, and
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enforceable, and seeking a declaratory judgment of invalidity. Barr also sought a declaratory judgment that the 428, 930, 145, and 181 patents are not infringed, and that the 428, 930 and 181 patents are invalid. The third case was consolidated with the first two on January 23, 2003. On March 4, 2003, Kos replied to Barrs declaratory judgment counterclaims by denying that Kos patents are invalid or not infringed. Kos also sought a declaratory judgment that one or more of Barrs products will infringe the 145 and 181 patents.
From time to time, the Company is a party to other legal proceedings in the course of its business. The Company, however, does not expect such other legal proceedings to have a material adverse effect on its business or financial condition.
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Item 6 Exhibits and Reports on Form 8-K
(a) Exhibits:
3.1* | Amended and Restated Articles of Incorporation of the Company. | |
3.2* | Amended and Restated Bylaws of the Company. | |
4.1 | See Exhibits 3.1 and 3.2 for provisions of the Amended and Restated Articles of Incorporation and Amended and Restated Bylaws of the Company defining the rights of holders of Common Stock of the Company. | |
4.2** | Form of Common Stock certificate of the Company. | |
99.1 | Certification by Adrian Adams, President and Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
99.2 | Certification by Christopher P. Kiritsy, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
99.3 | Audit Committee Charter (Revised) | |
99.4 | Code of Ethics for Senior Financial Officers |
(b) Reports on Form 8-K:
There were no reports filed on Form 8-K during the quarter ended March 31, 2003. |
* | Filed with the Companys Registration Statement on Form S-1 (File No. 333-17991), as amended, filed with the Securities and Exchange Commission on December 17, 1996, and incorporated herein by reference. | |
** | Filed with the Companys Registration Statement on Form 8-A filed with the Securities and Exchange Commission on February 25, 1997, and incorporated herein by reference. |
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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.
KOS PHARMACEUTICALS, INC | ||||
Date: May 14, 2003 | By: | /s/ Adrian Adams | ||
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Adrian Adams, President and | ||||
Chief Executive Officer | ||||
Date: May 14, 2003 | By: | /s/ Christopher P. Kiritsy | ||
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Christopher P. Kiritsy, Senior | ||||
Vice President, Chief Financial Officer | ||||
(Principal Financial Officer) | ||||
Date: May 14, 2003 | By: | /s/ Juan F. Rodriguez | ||
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Juan F. Rodriguez, Vice President, Controller | ||||
(Principal Accounting Officer) |
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CERTIFICATIONS
I, Adrian Adams, Chief Executive Officer of Kos Pharmaceuticals, Inc., certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Kos Pharmaceuticals, Inc; | ||
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which the statements were made, not misleading with respect to the period covered by this quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | ||
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a. | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | ||
b. | evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing of this quarterly report (the Evaluation Date); and | ||
c. | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent function): |
a. | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | ||
b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
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6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to the significant deficiencies and material weaknesses. |
Date: May 14, 2003
/s/ Adrian Adams
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I, Christopher P. Kiritsy, Chief Financial Officer of Kos Pharmaceuticals, Inc., certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Kos Pharmaceuticals, Inc; | ||
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which the statements were made, not misleading with respect to the period covered by this quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | ||
4. | The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
a. | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | ||
b. | evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing of this quarterly report (the Evaluation Date); and | ||
c. | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent function): |
a. | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | ||
b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to the significant deficiencies and material weaknesses. |
Date: May 14, 2003
/s/ Christopher P. Kiritsy
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