UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended June 30, 2003 |
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o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the transition period from ______________ to _______________ |
Commission file number 0-31781
American Pharmaceutical Partners, Inc.
(Exact name of registrant as specified in its charter)
Delaware | | 68-0389419 |
(State of Incorporation) | | (I.R.S. Employer Identification No.) |
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1101 Perimeter Drive, Suite 300 Schaumburg, IL | | 60173 |
(Address of principal executive offices) | | (Zip Code) |
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(847) 969-2700 (Registrant’s telephone number, including area code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant is an accelerated filer (as determined by rule 12b-2 of the Exchange Act).
As of August 8, 2003, the registrant had 46,387,538 shares of $0.001 par value Common Stock outstanding.
American Pharmaceutical Partners, Inc.
INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
American Pharmaceutical Partners, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data) | | June 30, 2003 | | December 31, 2002 | |
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| | (Unaudited) | | (Note 1) | |
Assets | | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 45,977 | | $ | 39,771 | |
Accounts receivable, net | | | 25,371 | | | 21,278 | |
Inventories | | | 85,487 | | | 77,736 | |
Prepaid expenses and other current assets | | | 6,644 | | | 3,610 | |
Deferred income taxes | | | 5,698 | | | 5,698 | |
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Total current assets | | | 169,177 | | | 148,093 | |
Deferred income taxes | | | 2,874 | | | 2,204 | |
Property, plant and equipment, net | | | 68,527 | | | 62,637 | |
Investment in Drug Source Co., LLC | | | 3,779 | | | 3,178 | |
Product license rights, net | | | 1,701 | | | 1,460 | |
Deferred financing costs, net | | | 2,978 | | | 3,404 | |
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Total assets | | $ | 249,036 | | $ | 220,976 | |
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Liabilities and stockholders’ equity | | | | | | | |
Current liabilities: | | | | | | | |
Accounts payable | | $ | 12,357 | | $ | 13,670 | |
Accrued expenses | | | 33,192 | | | 26,598 | |
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Total current liabilities | | | 45,549 | | | 40,268 | |
Stockholders’ equity | | | | | | | |
Common stock - $.001 par value; 100,000,000 shares authorized, 50,706,476 and 50,243,532 shares issued in 2003 and 2002, respectively | | | 51 | | | 50 | |
Additional paid-in capital | | | 195,529 | | | 189,630 | |
Amounts due from American BioScience, Inc. | | | (22,882 | ) | | (22,567 | ) |
Deferred stock-based compensation | | | (1,774 | ) | | (1,976 | ) |
Retained earnings | | | 88,730 | | | 51,857 | |
Accumulated other comprehensive income (loss) | | | 107 | | | (11 | ) |
Less treasury stock at cost, 4,430,932 common shares in 2003 and 3,366,877 in 2002 | | | (56,274 | ) | | (36,275 | ) |
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Total stockholders’ equity | | | 203,487 | | | 180,708 | |
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Total liabilities and stockholders’ equity | | $ | 249,036 | | $ | 220,976 | |
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See notes to condensed consolidated financial statements.
3
American Pharmaceutical Partners, Inc.
Condensed Consolidated Statements of Income
(Unaudited)
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
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| | 2003 | | 2002 | | 2003 | | 2002 | |
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| | (in thousands, except per share data) | |
Net sales | | $ | 90,416 | | $ | 69,039 | | $ | 171,761 | | $ | 122,891 | |
Cost of sales | | | 39,790 | | | 35,320 | | | 74,975 | | | 66,184 | |
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Gross margin | | | 50,626 | | | 33,719 | | | 96,786 | | | 56,707 | |
Operating expenses: | | | | | | | | | | | | | |
Research and development | | | 5,067 | | | 3,315 | | | 11,143 | | | 7,640 | |
Selling, general and administrative | | | 12,813 | | | 10,587 | | | 24,133 | | | 19,893 | |
Stock-based compensation | | | 311 | | | 566 | | | 733 | | | 1,428 | |
Equity in net income of Drug Source Co., LLC | | | (394 | ) | | (338 | ) | | (498 | ) | | (779 | ) |
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Total operating expenses | | | 17,797 | | | 14,130 | | | 35,511 | | | 28,182 | |
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Income from operations | | | 32,829 | | | 19,589 | | | 61,275 | | | 28,525 | |
Interest income | | | 429 | | | 567 | | | 895 | | | 1,075 | |
Interest expense and other | | | 332 | | | (299 | ) | | 326 | | | (721 | ) |
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Income before income taxes | | | 33,590 | | | 19,857 | | | 62,496 | | | 28,879 | |
Provision for income taxes | | | 13,772 | | | 8,802 | | | 25,623 | | | 12,717 | |
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Net income | | $ | 19,818 | | $ | 11,055 | | $ | 36,873 | | $ | 16,162 | |
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Income per common share: | | | | | | | | | | | | | |
Basic | | $ | 0.43 | | $ | 0.22 | | $ | 0.79 | | $ | 0.33 | |
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Diluted | | $ | 0.41 | | $ | 0.21 | | $ | 0.76 | | $ | 0.31 | |
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Interest income includes interest earned from American BioScience, Inc. as follows: | | $ | 310 | | $ | 302 | | $ | 625 | | $ | 595 | |
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See notes to condensed consolidated financial statements.
4
American Pharmaceutical Partners, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| | Six Months Ended June 30, | |
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| | 2003 | | 2002 | |
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| | (in thousands) | |
Cash flows from operating activities: | | | | | | | |
Net income | | $ | 36,873 | | $ | 16,162 | |
Adjustments to reconcile net income to net cash provided by operating activities: | | | | | | | |
Depreciation | | | 4,779 | | | 4,570 | |
Amortization | | | 456 | | | 455 | |
Imputed interest on liability to VivoRx, Inc. | | | — | | | 660 | |
Stock-based compensation | | | 733 | | | 1,428 | |
Deferred income taxes | | | (670 | ) | | (266 | ) |
Equity in net income of Drug Source Co., LLC | | | (601 | ) | | (780 | ) |
Income tax benefit on stock option exercises | | | 2,477 | | | 900 | |
Changes in operating assets and liabilities: | | | | | | | |
Accounts receivable, net | | | (4,093 | ) | | (9,847 | ) |
Inventories | | | (7,751 | ) | | (11,879 | ) |
Prepaid expenses and other current assets | | | (3,034 | ) | | (1,816 | ) |
Accounts payable and accrued expenses | | | 6,081 | | | 10,791 | |
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Net cash provided by operating activities | | | 35,250 | | | 10,378 | |
Cash flows from investing activities: | | | | | | | |
Purchases of property, plant and equipment | | | (10,939 | ) | | (7,047 | ) |
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Net cash used in investing activities | | | (10,939 | ) | | (7,047 | ) |
Cash flows from financing activities: | | | | | | | |
Proceeds from the exercise of stock options | | | 1,654 | | | 872 | |
Proceeds from the sale of stock under employee retirement and stock purchase plans | | | 437 | | | — | |
Distribution paid to American BioScience, Inc. | | | — | | | (60,000 | ) |
Increase in amounts due from American BioScience, Inc. | | | (315 | ) | | (1,522 | ) |
Payment of financing costs | | | — | | | (109 | ) |
Purchase of treasury stock | | | (19,999 | ) | | — | |
Proceeds from the issuance of common stock, net | | | — | | | 20,088 | |
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Net cash used in financing activities | | | (18,223 | ) | | (40,671 | ) |
Effect of foreign currency translation | | | 118 | | | — | |
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Increase (decrease) in cash and cash equivalents | | | 6,206 | | | (37,340 | ) |
Cash and cash equivalents at beginning of period | | | 39,771 | | | 96,688 | |
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Cash and cash equivalents at end of period | | $ | 45,977 | | $ | 59,348 | |
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See notes to condensed consolidated financial statements.
5
AMERICAN PHARMACEUTICAL PARTNERS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2003
(Unaudited)
(1) Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of American Pharmaceutical Partners, Inc. have been prepared in accordance with generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these financial statements do not include all of the information and notes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six-month periods ended June 30, 2003 are not necessarily indicative of the results that may be expected for the year ended December 31, 2003.
The balance sheet information at December 31, 2002 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles for complete financial statements.
A wholly owned subsidiary of American Pharmaceutical Partners holds a 50% interest in Drug Source Company, LLC. Drug Source Company is a joint venture with three other partners established in June 2000 to purchase raw materials for resale to pharmaceutical companies, including us. Because our 50% interest in Drug Source Company does not provide financial or operational control of the entity, we account for our interest in Drug Source Company under the equity method. Our equity in the net income of Drug Source Company, net of intercompany profit on purchases of inventory, is classified in operating expenses in the accompanying consolidated statements of income. Research and development costs included purchases from Drug Source Company of $0.2 million and $1.0 million for the six months ended June 30, 2003 and 2002, respectively. Inventory included raw material purchases from Drug Source Company of $0.1 million at June 30, 2003 and $1.8 million at December 31, 2002.
For further information, refer to the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2002.
(2) Quarterly Periods
We use a 52-week, 53-week fiscal year that ends on the Saturday nearest to December 31. For quarterly reporting purposes, the quarterly periods end on the Saturday nearest to the end of the quarter. For clarity of presentation, comparative periods are presented as if the quarters ended on June 30. Both of the three-month periods ended June 30, 2003 and 2002 contained 13 weeks, and both of the six-month periods ended June 30, 2003 and 2002 contained 26 weeks.
6
(3) Earnings Per Share Information
The following tables set forth the computation of basic and diluted earnings per share for the periods indicated:
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
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| | 2003 | | 2002 | | 2003 | | 2002 | |
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| | (in thousands except per share data) | |
Basic and dilutive numerator: | | | | | | | | | | | | | |
Net income applicable to common stock | | $ | 19,818 | | $ | 11,055 | | $ | 36,873 | | $ | 16,162 | |
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Denominator: | | | | | | | | | | | | | |
Weighted-average common shares outstanding - basic | | | 46,158 | | | 49,795 | | | 46,465 | | | 49,646 | |
Net effect of dilutive securities: | | | | | | | | | | | | | |
Stock options and restricted stock awards | | | 1,956 | | | 1,810 | | | 1,903 | | | 1,959 | |
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Weighted-average common shares outstanding - diluted | | | 48,114 | | | 51,605 | | | 48,368 | | | 51,605 | |
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Income per common share - basic | | $ | 0.43 | | $ | 0.22 | | $ | 0.79 | | $ | 0.33 | |
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Income per common share - diluted | | $ | 0.41 | | $ | 0.21 | | $ | 0.76 | | $ | 0.31 | |
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(4) Recent Accounting Pronouncements
In January 2003, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 46, Consolidation of Variable Interest Entities, an Interpretation of Accounting Research Bulletin No. 51 (“FIN 46”). FIN 46 requires consolidation, beginning July 1, 2003, of entities in which we absorb a majority of the entity’s expected losses, receive a majority of the entity’s expected residual returns, or both, as a result of ownership, contractual or other financial interests in the entity. Currently, entities are consolidated when the company has a controlling financial interest through ownership of a controlling voting interest in an entity.
We hold a 50% ownership interest in Drug Source Company, a joint venture with three other partners to purchase raw materials for resale to pharmaceutical companies, including ourselves. We will continue to account for our investment in Drug Source Company under the equity method. Accordingly, FIN 46 will not have a material impact on our financial statements or results of operations.
In addition, during the three months ended June 30, 2003 the FASB issued two new standards. We do not believe that either of these new standards will have a material impact on our financial condition or results of operations.
Statement of Financial Accounting Standards No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging Activities, was issued in April 2003. This statement amends and clarifies financial accounting and reporting for hedging activities and for derivative instruments (including certain derivative instruments embedded in other contracts.) These changes are intended to improve financial reporting by requiring contracts with comparable characteristics to be accounted for similarly. This statement is effective for contracts entered into or modified after June 30, 2003.
Statement of Financial Accounting Standards No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, was issued in May 2003. This statement establishes standards for clarifying and measuring certain financial instruments with characteristics of both liabilities and equity. It requires that an issuer classify a financial instrument that is within its scope as a liability. Many of those instruments could previously be classified as equity. This statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003.
7
(5) Transactions with American BioScience, Inc.
Product License and Manufacturing Agreements
In November 2001, we signed a perpetual license agreement with American BioScience, Inc. under which we acquired the exclusive rights to market and sell ABI-007 in North America for indications relating to breast, lung, ovarian, prostate and other cancers. Under the agreement, we made an initial payment to American BioScience of $60.0 million and committed to future milestone payments contingent upon achievement of specified regulatory and sales objectives for licensed indications. American BioScience is responsible for conducting clinical studies in support of ABI-007 and for substantially all costs associated with the development and obtaining regulatory approval for ABI-007, except that we provided $2.0 million of ABI-007 for use in clinical trials, the cost of which we charged to research and development expense in 2001. We may receive revenue resulting from this agreement only after our launch of ABI-007 in North America, which will not occur until after FDA approval is obtained. Even though we anticipate that American BioScience will complete its filing of the NDA for ABI-007 for metastatic breast cancer by the end of 2003, we cannot predict when the FDA will complete its review of the filing, or when or if the NDA may be approved. Any resulting profit would be shared equally between American BioScience and us.
The terms of the license agreement were negotiated to reflect the $60.0 million value of the licensed product rights acquired, then in late-stage development, the value of American BioScience’s remaining obligation to complete the NDA filing and the value of potential sales of the product under other licensed clinical indications. The license agreement was a product of several months of extensive negotiation with American BioScience involving outside counsel, investment banks and a nationally recognized valuation firm. Based upon the analysis and recommendations of our advisors, we believe that the overall terms of the agreement were fair to us and within parameters of similar licenses between unrelated parties. The agreement was unanimously approved by the disinterested members of our Board of Directors with those directors who also have an affiliation with American BioScience recusing themselves from the vote. There are no restrictions on how American BioScience would use payments made under the license agreement and we understand such payments have been and will be used both to fund the development of ABI-007 in relation to our licensed product rights and for other purposes.
In December 2001, upon completion of our initial public offering, we recorded an initial payment to American BioScience of $60.0 million. In our financial statements, the license agreement was accounted for as an asset contributed by a principal shareholder using the shareholder’s historical cost basis which was zero, and the $60.0 million payment was accounted for as a distribution of stockholders’ equity. Because there was no corresponding charge to income, the income tax benefit of this payment is being credited to stockholders’ equity as realized. For income tax purposes, the payment was recorded as an asset and is being amortized over a 15-year period.
Future milestone payments which will be earned upon achievement of regulatory events prior to FDA approval for each licensed indication will be expensed as achieved, while regulatory milestone payments earned upon FDA approval of those indications will be capitalized and amortized over the expected life of the product. Any future sales based milestone payments will be expensed in the period in which the sales milestone is achieved.
With respect to the first potential ABI-007 indication being studied, metastatic breast cancer, we will be required to pay American BioScience $10.0 million within 30 days of FDA acceptance for filing of an NDA for this indication, meaning that the FDA has found the NDA complete on its face in all respects. Upon FDA approval of the NDA for metastatic breast cancer, we will be required to pay American BioScience an additional $15.0 million. The $10.0 million payment upon FDA acceptance of filing will be expensed in the period of FDA acceptance while the $15.0 million payment related to FDA approval will be capitalized and amortized over the expected life of the product, subject to periodic review for impairment. Regulatory achievements related to other licensed indications under study, including lung, ovarian and prostate cancers, will trigger further milestone payments to American BioScience, but only after ABI-007 has received NDA approval related to the breast cancer indication. Such payments generally total $17.5 million per agreed indication. As with the indication of breast cancer, those payments earned prior to FDA approval for each indication will be expensed, while amounts earned upon FDA approval of those indications will be capitalized and amortized over the expected life of the product. We have the option not to make one or more of the milestone payments tied to indications under study if, following breast cancer approval, sales of the product do not meet specified levels.
8
Subsequent to FDA approval of ABI-007 and upon achievement of major annual ABI-007 sales milestones, we would be required to make additional payments which, in the aggregate, could total $110.0 million should annual ABI-007 sales exceed $1.0 billion. The first sales milestone payment of $10.0 million would be triggered upon achievement of annual calendar year ABI-007 sales in excess of $200.0 million. Sales milestone payments will be expensed in the period in which the sales milestone is achieved.
Under the license agreement, any profit on ABI-007 net sales in North America would be shared equally between American BioScience and us. The license agreement defines profit as ABI-007 net sales in North America less cost of goods sold, selling expenses (including pre-launch production and marketing expenses which we will expense as incurred, but which will be accumulated and charged against first profit under the agreement) and an allocation of related general and administrative expenses. We will expense American BioScience’s share of any profit earned in our statements of income. Any costs and expenses related to product recalls and product liability claims generally will be split equally between American BioScience and us and expensed as incurred.
In November 2001, along with the license agreement for ABI-007, we also entered into a manufacturing agreement with American BioScience under which we agreed to manufacture ABI-007 for American BioScience and its licensees for sales outside North America. Under this agreement, we have the exclusive right to manufacture ABI-007 for sales in North America for a period of three years and the non-exclusive right to manufacture ABI-007 for sales (a) outside North America and (b) in North America after expiration of the three year exclusivity period. We will charge American BioScience and its licensees a customary margin on our manufacturing costs based on whether the product will be used for clinical trials or commercial sale. The initial term of this agreement is ten years and may be extended for successive two-year terms by American BioScience.
Loans to American BioScience, Inc.
In the past, prior to our licensing of ABI-007, we made loans to American BioScience, our parent, which were reflected in various promissory notes. The current demand promissory note, which replaced prior notes, from American BioScience for the outstanding loan balance (“Demand Note”) is capped at $23.0 million and bears interest at a rate equal to the rate of interest on our credit facility, 5.25% at June 30, 2003. American BioScience is required to repay any amounts outstanding under the Demand Note by the earlier of November 20, 2006 or the cumulative payment by APP of $75.0 million of profit on ABI-007 to American BioScience. As security for American BioScience’s obligations under the Demand Note, American BioScience pledged and granted to us a security interest in shares of our common stock held by American BioScience having a fair market value equal to 120% of the balance of the Demand Note.
9
We charge payments made on American BioScience’s behalf related to costs to manufacture product for use by American BioScience in its clinical studies and other costs directly related and in support of American BioScience’s development of ABI-007, income taxes, interest and an agreed allocation of administrative costs to the American BioScience loan account. A summary of activity in the amounts due from American BioScience, which is classified as a reduction of stockholders equity in the accompanying consolidated balance sheets, follows:
| | June 30, 2003 | | December 31, 2002 | |
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Balance at beginning of year | | $ | 22,567 | | $ | 20,957 | |
Payments on behalf of ABI: | | | | | | | |
Manufacture of clinical product, regulatory costs and other | | | 861 | | | 6,108 | |
Interest charged to ABI | | | 625 | | | 1,244 | |
Other | | | 11 | | | 107 | |
Reductions in lieu of income tax liability | | | — | | | (404 | ) |
Repayments by ABI | | | (1,182 | ) | | (5,445 | ) |
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| | $ | 22,882 | | $ | 22,567 | |
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American BioScience
We are a majority owned subsidiary of American BioScience. American BioScience is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic compounds including ABI-007 and a variety of biologically active molecules, already existing within the human biological system, for the treatment of life-threatening diseases. American BioScience’s employees, administration and research facilities are independent, separate and distinct from our operations. Except for our President, Chief Executive Officer and Chairman of our Board of Directors, Patrick Soon-Shiong, M.D., no full time employee of American BioScience is also an employee of ours. Even though Dr. Soon-Shiong is also the president, chief financial officer and a director of American BioScience, we believe that compensation paid to Dr. Soon-Shiong by us is commensurate with his duties to us.
Under the license agreement, American BioScience is responsible for conducting clinical studies in support of ABI-007 and for substantially all costs associated with the development and obtaining regulatory approval for ABI-007, for each indication licensed to us. Other than the $2.0 million of ABI-007 that we provided American BioScience in 2001 for use in clinical trials, we have no further obligation under the license agreement for the development or regulatory approval of ABI-007. Due to the multiple ABI-007 indications which we license, American BioScience’s obligations under the license agreement will be ongoing and we cannot predict when American BioScience will be able to complete the development and regulatory approval of each of these indications. We anticipate that American BioScience will complete the filing of the NDA for the first indication for which it has an obligation, metastatic breast cancer, by the end of 2003.
American BioScience began research and development work on its nanoparticle drug delivery platform, including ABI-007, in 1994. Prior to execution of the license agreement, American BioScience had completed multiple pre-clinical animal studies, two Phase I human studies and two Phase II clinical studies. After execution of the license agreement, American BioScience completed a single Phase III clinical study in metastatic breast cancer as a basis for FDA approval and is in the process of accumulating the data of this Phase III study, which we anticipate to be unblinded and evaluated in the 3rd and 4th quarters of 2003. In June 2003, American BioScience began the ABI-007 NDA filing process with the pre-submission of the pre-clinical and Chemistry, Manufacturing and Control sections of the NDA under the Fast Track designation granted ABI-007 by the FDA earlier this year, and anticipates completion of the entire filing in 2003. American BioScience is also conducting a Phase II clinical trial to explore a weekly dosing regimen of ABI-007 in metastatic breast cancer patients in which prior taxane therapy failed and is evaluating ABI-007 in non-small cell lung, ovarian, melanoma and cervical cancers, the rights to which we have licensed. The results of these Phase I, II and III clinical studies will be used in support of American BioScience’s ABI-007 NDA filing for indications and uses licensed to us by American BioScience, but this data may also support products currently in development by American BioScience for which we did not acquire any rights under the license agreement.
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(6) Inventories
Inventories consist of the following:
| | June 30, 2003 | | December 31, 2002 | |
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Finished goods | | $ | 32,106 | | $ | 26,268 | |
Work in process | | | 12,804 | | | 14,171 | |
Raw materials | | | 40,577 | | | 37,297 | |
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| | $ | 85,487 | | $ | 77,736 | |
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Inventory increased due to increased raw material inventory in anticipation of new product launches and to facilitate higher finished goods stocking levels of certain products previously on backorder so as to improve responsiveness to customer demand and to support increased sales volume.
(7) Accrued Liabilities
Accrued liabilities consist of the following:
| | June 30, 2003 | | December 31, 2002 | |
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Sales and marketing | | $ | 8,914 | | $ | 9,389 | |
Accrued income taxes | | | 7,900 | | | 1,229 | |
Legal and insurance | | | 7,631 | | | 7,137 | |
Payroll and employee benefits | | | 7,195 | | | 7,470 | |
Other | | | 1,552 | | | 1,373 | |
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| | $ | 33,192 | | $ | 26,598 | |
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(8) Credit Facility
Our credit facility is comprised of a $50.0 million revolving line of credit which can be increased to $75.0 million at our request and expires December 14, 2006. In the first quarter of 2003, the credit agreement was amended to increase the 2003 limit on capital expenditures from $25.0 million to $35.0 million. Additionally, during April 2003, the credit facility was amended, for a period of up to six months, to permit the reacquisition of up to $20.0 million of our common stock, subject to our having at least $10.0 million in cash on hand and no borrowings outstanding under the credit facility at the time of repurchase.
There were no outstanding balances under the revolving lines of credit at June 30, 2003 or December 31, 2002. The interest rate under the revolving line equals the sum of an adjustable margin rate (1.25% as of June 30, 2003) plus the greater of the prime rate or the federal funds rate plus 0.5%. We also have the option of converting revolving line loans to the Eurocurrency rate, as defined.
Borrowings under the credit facility are collateralized by substantially all of our assets. The credit facility prohibits us from paying cash dividends and includes various other covenants and restrictions. At June 30, 2003, we were in compliance with all covenants.
The credit facility limits the aggregate undrawn amount of all letters of credit and assesses a 3.75% fee on the face amount of commercial and standby letters of credit. The letters of credit are payable on demand. There were no outstanding letters of credit at June 30, 2003.
No interest expense was capitalized during the three and six month periods ending June 30, 2003 and 2002.
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(9) Exercise of Over-allotment Option
On January 10, 2002, the underwriters of our December 2001 initial public offering exercised in full their over-allotment option to purchase an additional 1,350,000 shares of our common stock at the initial public offering price of $16.00 per share. As a result of this exercise, in the 2002 first quarter we received proceeds of $20.1 million, net of underwriting discounts and commissions of $1.5 million.
(10) Stock Options and Restricted Stock
During the six months ended June 30, 2003, options for the purchase of 462,400 shares of our common stock were granted at an average exercise price of $20.10 and options for 396,802 shares were exercised at an average exercise price of $4.18. Stock based compensation charges were $0.3 million and $0.6 million for the three months ended June 30, 2003 and 2002, respectively, and $0.7 million and $1.4 million for the six months ended June 30, 2003 and 2002, respectively.
On February 25, 2003, 28,000 of restricted common shares, having a market value on that date of $22.03 per share, were issued under the 2001 Stock Option Plan. Three-quarters of the shares vest three years from date of grant with the remainder vesting four years from the date of grant. Compensation expense related to restricted stock grants is based upon the market price on date of grant and charged to earnings on a straight-line basis over the vesting period. Compensation expense related to the restricted shares was insignificant in the three and six month periods ending June 30, 2003. This restricted stock grant will result in compensation expense of approximately $0.2 million for the current fiscal year ending December 31, 2003.
The following table illustrates the pro forma effect on net income and income per common share had we applied the fair value recognition provisions of Statement of Financial Accounting Standards No. 123 Accounting for Stock-Based Compensation :
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
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(in thousands, except per share data) | | 2003 | | 2002 | | 2003 | | 2002 | |
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Net income, as reported | | $ | 19,818 | | $ | 11,055 | | $ | 36,873 | | $ | 16,162 | |
Add: Stock-based employee compensation expense included in reported net income, net of related tax effects | | | 184 | | | 322 | | | 432 | | | 814 | |
Deduct: Total stock-based employee compensation expense determined under the fair value based method for all awards, net of related tax effects | | | (752 | ) | | (554 | ) | | (1,432 | ) | | (1,091 | ) |
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Pro forma net income | | $ | 19,250 | | $ | 10,823 | | $ | 35,873 | | $ | 15,885 | |
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Net income per common share: | | | | | | | | | | | | | |
Basic - as reported | | $ | 0.43 | | $ | 0.22 | | $ | 0.79 | | $ | 0.33 | |
Basic - pro forma | | $ | 0.42 | | $ | 0.22 | | $ | 0.77 | | $ | 0.32 | |
Diluted - as reported | | $ | 0.41 | | $ | 0.21 | | $ | 0.76 | | $ | 0.31 | |
Diluted - pro forma | | $ | 0.40 | | $ | 0.21 | | $ | 0.74 | | $ | 0.31 | |
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(11) Treasury Stock
On July 29, 2002, we repurchased all 2,914,593 shares of our common stock held by Premier Purchasing Partners, L.P. for $30.3 million in cash including transaction costs. In addition, on August 28, 2002, we repurchased 452,284 shares of our common stock owned by Biotechnology Development Fund, L.P. for $6.0 million in cash pursuant to a stock repurchase program adopted by our Board of Directors on July 26, 2002.
During the period between December 31, 2002 and March 19, 2003, we repurchased 1,064,055 shares of our common stock on the open market for $20.0 million pursuant to a stock repurchase program approved by our Board of Directors on December 10, 2002.
These repurchases were funded using internal cash resources and the shares will be held as treasury shares to be used for general corporate purposes.
Additionally, on April 24, 2003, our Board of Directors amended our stock repurchase program to authorize, from time-to-time, the repurchase of up to an additional $20.0 million of our common stock through open market purchases and privately negotiated transactions. No repurchases have been made under the April 24, 2003 authorization.
(12) Litigation
We are from time to time subject to claims and litigation arising in the ordinary course of business. These claims have included assertions that our products infringe existing patents and also claims that the use of our products has caused personal injuries. We intend to defend vigorously any such litigation that may arise under all defenses that would be available to us. In the opinion of management, the ultimate outcome of such proceedings of which management is aware will not have a material adverse effect on our consolidated financial position or results of operation.
(13) Net Sales by Product Line
Net sales by product line is as follows:
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
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Oncology | | $ | 23,804 | | $ | 17,640 | | $ | 43,130 | | $ | 27,123 | |
Anti-infective | | | 21,826 | | | 15,610 | | | 44,182 | | | 30,210 | |
Critical care | | | 44,249 | | | 33,275 | | | 82,390 | | | 61,331 | |
Contract manufacturing | | | 424 | | | 2,246 | | | 1,716 | | | 3,701 | |
Other | | | 113 | | | 268 | | | 343 | | | 526 | |
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| | $ | 90,416 | | $ | 69,039 | | $ | 171,761 | | $ | 122,891 | |
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(14) Enterprise Resource Planning System
In March 2002, we entered into various licensing and support agreements for the implementation of a new enterprise resource planning (ERP) business system application. Through June 30, 2003, we had capitalized $10.8 million in construction in progress for license fees, hardware and other costs related to this project.
(15) Subsequent Event
On August 8, 2003, the Board of Directors of American Pharmaceutical Partners declared a three-for-two stock split in the form of a stock dividend. The stock dividend will be paid on September 2, 2003 to stockholders of record on August 18, 2003. The stock split will require the retroactive restatement of all historical share and per share data in the third quarter ending September 30, 2003.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Note Regarding Forward-Looking Statements
Statements contained in this Quarterly Report on Form 10-Q, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to:
| • | the impact of competitive products and pricing; |
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| • | the availability and pricing of raw materials and components used in the manufacture of our pharmaceutical products; |
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| • | the ability to successfully manufacture products in an efficient, time-sensitive and cost effective manner; |
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| • | the acceptance of and demand for our existing and new pharmaceutical products; |
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| • | our ability, and that of our suppliers, to comply with laws, regulations, and standards, and the application and interpretation of those laws, regulations, and standards, that govern or affect the pharmaceutical industry, the non-compliance with which may delay or prevent the sale of our products; |
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| • | the impact on our products and revenues of patents and other proprietary rights licensed or owned by us, our competitors and other third parties; |
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| • | the difficulty in predicting the outcome or timing of product development efforts and regulatory approvals; |
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| • | the actual results achieved in the ongoing and future clinical trials for ABI-007; |
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| • | the timing of the completion of the ongoing and future clinical trials for ABI-007; |
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| • | the timing of and costs associated with the expected launch of ABI-007; |
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| • | licenses or acquisitions; and |
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| • | relationships and agreements with other parties. |
Forward-looking statements also include the assumptions underlying or relating to any of the foregoing or other such statements. When used in this report, the words “may,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “continue,” and similar expressions are generally intended to identify forward-looking statements.
Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s opinions only as of the date hereof. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements.
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Overview
American Pharmaceutical Partners, Inc. is a specialty pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products. Currently, we market and manufacture over 130 generic injectable pharmaceutical products in more than 350 dosages and formulations. The generic injectable pharmaceutical marketplace is characterized by additional competitors entering the market for specific products, forcing existing sellers to lower prices on those products to maintain market share. Generally, we select innovative products for development that we believe will provide higher returns. We strive to develop new products so that we can obtain regulatory approval coincident with expiration of any existing patents which would otherwise block approval or marketing. It is our goal with certain of the products we develop to be the first generic competitor approved, in order to capture market share and optimize growth, particularly if we are able to secure the 180-day exclusivity available under the law for certain of our products. Our strategy has been to launch a number of new products approved via abbreviated new drug applications (ANDAs), each year to drive increases in revenue and gross margin. As a result of this strategy, to-date in 2003 we have received FDA approval of three final and two tentative ANDAs and in 2002, we received approval for 13 ANDAs. We presently have 14 ANDAs pending with the FDA and more than 50 injectable products in various stages of development. These products are spread evenly over our three areas of focus: oncology, anti-infectives and critical care.
Results of Operations
The following table sets forth the results of our operations for the periods indicated as a percentage of net sales:
| | Three Months Ended June 30, | | Six Months Ended June 30, | |
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Net sales | | | 100.0 | | | 100.0 | | | 100.0 | | | 100.0 | |
Cost of sales | | | 44.0 | | | 51.2 | | | 43.7 | | | 53.9 | |
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Gross margin | | | 56.0 | | | 48.8 | | | 56.3 | | | 46.1 | |
Operating expenses: | | | | | | | | | | | | | |
Research and development | | | 5.6 | | | 4.8 | | | 6.5 | | | 6.2 | |
Selling, general and administrative | | | 14.2 | | | 15.3 | | | 14.0 | | | 16.2 | |
Stock-based compensation | | | 0.3 | | | 0.8 | | | 0.4 | | | 1.2 | |
Equity in net income of Drug Source Co., LLC | | | (0.4 | ) | | (0.5 | ) | | (0.3 | ) | | (0.7 | ) |
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Total operating expenses | | | 19.7 | | | 20.4 | | | 20.6 | | | 22.9 | |
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Income from operations | | | 36.3 | | | 28.4 | | | 35.7 | | | 23.2 | |
Interest income | | | 0.5 | | | 0.8 | | | 0.5 | | | 0.9 | |
Interest expense and other | | | 0.3 | | | (0.4 | ) | | 0.2 | | | (0.6 | ) |
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Income before income taxes | | | 37.1 | | | 28.8 | | | 36.4 | | | 23.5 | |
Provision for income taxes | | | 15.2 | | | 12.8 | | | 14.9 | | | 10.3 | |
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Net income | | | 21.9 | | | 16.0 | | | 21.5 | | | 13.2 | |
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Three Months Ended June 30, 2003 and 2002
Net sales. Net sales increased $21.4 million, or 31%, to $90.4 million for the three months ended June 30, 2003 from $69.0 million in the same period last year. The increase was due primarily to increased sales of more mature products due to both strong demand and favorable markets, and the benefit of nine new products that were launched over the prior 18 months. Each of the anti-infective, oncology and critical care categories contributed significantly to the second quarter 2003 net sales increase, increasing 40%, 35%, and 33%, respectively.
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Cost of sales. Cost of sales was $39.8 million, or 44.0% of net sales, and $35.3 million, or 51.2% of net sales, in the second quarters of 2003 and 2002, respectively. As compared to the prior year second quarter, the reduction in cost of sales as a percentage of net sales was primarily due to the introduction of new higher margin products and to strength across our base generic injectable product lines. Newly approved and marketed generic injectable products typically yield significantly higher gross margins than do mature products. As compared to the prior year quarter, the second quarter 2003 decline in cost of sales as a percentage of net sales also benefited from efficiencies gained from higher unit production volumes, reflecting strong demand for our products.
Research and development. Research and development costs were $5.1 million and $3.3 million in the 2003 and 2002 second quarters, respectively. The $1.8 million increase resulted primarily from increased cost of raw material used in development activity and from final pre-production work on products in late-stage development, including ABI-007.
Selling, general and administrative (“SG&A”). SG&A expense was $12.8 million, or 14.2% of net sales, and $10.6 million, or 15.3% of net sales, in the second quarters of 2003 and 2002, respectively, an increase of $2.2 million, or 21%. The increase in SG&A expense was primarily due to increased staffing requirements resulting from rapid sales growth and investment in technology and infrastructure.
Stock-based compensation. Stock-based compensation was $0.3 million and $0.6 million in the 2003 and 2002 second quarters, respectively. Stock-based compensation expense results primarily from the issuance, prior to the our initial public offering, of stock based compensation for which the exercise price was less than the estimated fair value of common stock on the grant date.
Equity in Drug Source Co., LLC. Drug Source Co., LLC (“DSC”), is a 50% owned company, which acts as a selling agent of raw material to the pharmaceutical industry, including American Pharmaceutical Partners. Our second quarter 2003 purchases from DSC consisted of $0.1 million of raw materials purchased for use in our commercial injectable products. No materials were purchased for use in our research and development activities in the 2003 second quarter. Because our 50% ownership interest in DSC does not provide financial or operational control of the entity, we account for our interest in DSC under the equity method. Our equity in income of DSC was $0.4 million in the second quarter of 2003 as compared to $0.3 million in the second quarter of 2002.
Interest income. Interest income was $0.4 million and $0.6 million the 2003 and 2002 second quarters, respectively. Interest income consists primarily of interest earned on the intercompany note from American BioScience and on invested cash. The reduction in interest income as compared to the prior year quarter was due primarily to lower interest rates and lower average cash investments.
Interest expense and other. Interest expense was a credit of $0.3 million in the 2003 second quarter as compared to a charge of $0.3 million in the same period last year. The 2003 credit resulted primarily from foreign currency exchange gains on the intercompany trading account with Pharmaceutical Partners of Canada, our wholly owned subsidiary. Interest expense in the prior year period resulted from imputed non-cash interest on a litigation settlement.
Provision for income taxes. Income tax expense was $13.8 million and $8.8 million in the 2003 and 2002 second quarters, respectively. Our effective tax rate was 41.0% and 44.3% for the 2003 and 2002 second quarters, respectively, with the decline in effective rates due primarily to a shift in the mix of our taxable state income.
Six Months Ended June 30, 2003 and 2002
Net sales. Net sales increased $48.9 million, or 40%, to $171.8 million for the six months ended June 30, 2003 versus $122.9 million in the same period last year. The increase was due primarily to eight new product launches during the prior fiscal year, favorable demand and pricing for more mature products at higher margins and first quarter market opportunities to fill unmet market needs. Products within each of the anti-infective, oncology and critical care categories launched over the course of 2002 contributed significantly to the net sales increase in the first half of 2003.
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Cost of sales. Cost of sales was $75.0 million, or 43.7% of net sales, and $66.2 million, or 53.9% of net sales, in the 2003 and 2002 first halves, respectively. The 2003 first half decline in cost of sales as a percentage of net sales was primarily due to the introduction of new, higher margin products, favorable generic injectable markets and higher margin market opportunities for certain existing products in the first quarter. The 2003 decline in cost of sales as a percentage of net sales also benefited from efficiencies resulting from higher unit production volumes, reflecting both strong demand for our products and higher ending finished goods inventory as compared to the prior year.
Research and development. Research and development costs were $11.1 million and $7.6 million in the six months ended June 30, 2003 and 2002, respectively. The $3.5 million increase resulted primarily from increased use of raw materials and increased product development activity.
Selling, general and administrative. SG&A expense was $24.1 million, or 14.0% of net sales, and $19.9 million, or 16.2% of net sales, in the first half of 2003 and 2002, respectively, an increase of $4.2 million, or 21%. The increase in SG&A expense was primarily due to increased staffing requirements resulting from rapid sales growth, increased technology infrastructure and higher risk management costs.
Stock-based compensation. Stock-based compensation was $0.7 million and $1.4 million in the six month periods ended June 30, 2003 and 2002, respectively. Stock-based compensation expense results primarily from the issuance, prior to the our initial public offering, of stock based compensation for which the exercise price was less than the estimated fair value of common stock on the grant date. The 2003 decline in stock based compensation expense resulted primarily from the accelerated amortization schedule of such costs.
Equity in Drug Source Co., LLC. Our equity in income of DSC was $0.5 million in the first half of 2003 as compared to $0.8 million in the first half of 2002. Our purchases from DSC in the first half of 2003 consisted of $0.2 million of raw materials for use in our research and development activities and $0.1 million of raw materials purchased for use in our commercial injectable products.
Interest income. Interest income was $0.9 million and $1.1 million in the six months ended June 30, 2003 and 2002, respectively. Interest income consists primarily of interest earned on the intercompany note from American BioScience and on invested cash.
Interest expense and other. Interest expense and other was a credit of $0.3 million in the 2003 first half as compared to $0.7 million in expense during the same period last year. The current year credit resulted from a foreign exchange gain on the intercompany trading account with Pharmaceutical Partners of Canada, our wholly owned subsidiary. Interest expense in the prior year period resulted from imputed non-cash interest on a litigation settlement.
Provision for income taxes. Income tax expense was $25.6 million and $12.7 million in the 2003 and 2002 second quarters, respectively. The effective tax rate was at 41.0% and 44.0% for the 2003 and 2002 second quarters, respectively, with the decline in effective rates due primarily to a shift in the mix of our taxable state income.
Significant Accounting Policies and Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant estimates in our consolidated financial statements are discussed below. Actual results could vary from those estimates.
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Revenue recognition
We recognize revenue from the sale of a product when that product is shipped to a customer, acceptance terms are fulfilled and no significant contractual obligations remain. We sell a majority of our products to wholesalers, who generally sell our products to hospitals or alternative healthcare facilities at contractual prices previously agreed upon between us and group purchasing organizations, or GPOs, on behalf of such end users. GPOs enter into collective purchasing contracts with pharmaceutical suppliers for products in an effort to secure favorable drug pricing on behalf of their members. We invoice wholesalers at our wholesale list price. Net sales represent our wholesale list price offset by wholesaler chargebacks, further adjusted for estimated discounts and contractual allowances, including GPO fees. Wholesaler chargebacks represent the difference between the wholesale list price and the estimated contractual sales price, based upon our historical experience.
The most significant estimates that affect net sales are wholesaler chargebacks, sales credits and cash discounts. The wholesaler chargeback calculation is computed as described in the following paragraph. The allowances for doubtful accounts, cash discounts and sales credits are estimated monthly by applying historical percentages (based on credits issued for each category), which are reassessed periodically, to the product sales for the month.
Chargebacks
The majority of our products are distributed through independent pharmaceutical wholesalers. In accordance with industry practice, sales to wholesalers are initially transacted at wholesale list price. The wholesalers then generally sell to an end user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously contractually established between the end user and American Pharmaceutical Partners, most often through a GPO.
When we initially record a sale to a wholesaler, the sale and resulting receivable are recorded at our list price. However, experience indicates that most of these selling prices will eventually be reduced to a lower, end-user contract price. Therefore, at the time of the sale, a contra asset is recorded for, and revenue is reduced by the difference between the list price and the estimated average end-user contract price. This is calculated by product code, taking the expected number of outstanding wholesale units sold that will ultimately be sold under end-user contracts multiplied by the anticipated, weighted-average contract price. Thus, a contra asset is established, reducing the initial wholesaler receivable by the difference between the initial list price and the estimated, ultimate end-user selling price. In addition, cash advance credits are also periodically issued to wholesalers as a standard trade practice and an estimated reserve for such discounts is established at the time of sale. When the wholesaler ultimately sells the product to the end user at the end-user contract price, the wholesaler charges us (“chargeback”) for the difference between the list price and the end-user contract price and such chargeback is offset against our initial estimated contra asset.
Expense recognition
Cost of sales represents the costs of the products which we have sold and consists of labor, raw materials, components, packaging, quality assurance and quality control, shipping and manufacturing overhead costs and the cost of finished products purchased from third parties. Our inventories are valued at the lower of cost or market as determined under the first-in, first-out (“FIFO”) method.
Research and development costs are expensed as incurred or consumed and consist primarily of salaries and other personnel-related expenses, as well as depreciation of equipment, allocable facility, raw material and production expenses and contract and consulting fees. We have made, and intend to make, substantial investment in research and development to expand our new product offerings and grow our business.
Selling, general and administrative expenses consist primarily of salaries, commissions and other personnel-related expenses, as well as costs for travel, trade shows and conventions, promotional material and catalogs, advertising and promotion, administrative facility costs and professional fees for general, legal and accounting services. We believe that our selling, general and administrative expenses will continue to increase due to the anticipated growth of our business.
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Stock-based compensation
Stock-based compensation represents the difference between the exercise price of options or restricted shares granted and the deemed fair value of our common stock on the grant date in accordance with Accounting Principles Board Opinion No. 25 Accounting for Stock Issued to Employees and its related interpretations. We recognize stock-based compensation over the applicable vesting period, typically four years, on an accelerated basis using the graded vesting method in accordance with Financial Accounting Standards Board Interpretation No. 28 Accounting for Stock Appreciation Rights and Other Variable Stock Option Plans.
Liquidity and Capital Resources
Net cash provided by operating activities was $35.3 million in the six months ended June 30, 2003, as compared to $10.4 million in the same period last year. The $24.9 million increase in cash flow from operations in the 2003 first half as compared to the prior year period resulted primarily from the $20.7 million increase in net income and a $4.0 million slower rate of increase in working capital requirements.
Net cash used in investing activities, consisting primarily of capital expenditures, was $10.9 million in the six months ended June 30, 2003, as compared to $7.0 million in the first half of the prior year. Investing activities primarily consist of capital expenditures supporting additional or improved manufacturing capacity and information technology initiatives and infrastructure improvements.
Net cash used in financing activities was $18.2 million and $40.7 million in the six months ended June 30, 2003 and 2002, respectively. The $18.2 million net use of cash for financing in the 2003 first half resulted primarily from the first quarter repurchase of 1,064,055 shares of our common stock on the open market for $20.0 million pursuant to a December 10, 2002 authorization by our Board of Directors. These repurchases were funded using our internal cash resources and the repurchased shares are being held as treasury shares and used for general corporate purposes. Net cash used for financing activities in the 2002 first half consisted primarily of the initial $60.0 million payment to our majority stockholder, American BioScience, for ABI-007 product license rights, partially offset by $20.1 million in proceeds from the January 2002 over-allotment exercise. Due to its related party nature, the prior year $60.0 million license payment to our majority stockholder has been presented as a financing activity on the cash flow statement, consistent with its treatment as a direct reduction in stockholders equity on our balance sheet.
Additionally, on April 24, 2003, our Board of Directors amended our stock repurchase program to authorize the repurchase, from time to time, of up to an additional $20.0 million of our common stock through open market purchases and privately negotiated transactions. No repurchases have been made under the April 24, 2003 authorization.
Our credit facility is comprised of a $50.0 million revolving line of credit which can be increased to $75.0 million at our request and expires on December 14, 2006. Borrowings under the credit facility are secured by substantially all of our assets. The credit facility also prohibits us from paying cash dividends and includes other covenants and restrictions. There were no balances outstanding under our credit facility at June 30, 2003 or December 31, 2002 and we were in compliance with all covenants at June 30, 2003. In the first quarter of 2003, the credit agreement was amended to increase the 2003 limit on capital expenditures from $25.0 million to $35.0 million. Additionally, during April 2003, the credit facility was amended, for a period of up to six months, to permit the reacquisition of up to $20.0 million of our common stock, subject to our having at least $10.0 million in cash on hand and no borrowings outstanding under the credit facility at the time of repurchase.
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Our capital requirements depend on numerous factors, including: the requirements of our product development; the need for manufacturing expansion and improvement and information technology requirements; increasingly in late 2003, inventory requirements and pre-launch costs related to the ABI-007 commercialization effort; the requirements of any acquisition strategy that may be adopted by our Board of Directors; and the amount of cash generated by operations. We may also repurchase additional shares of our common stock from time to time, at the discretion of our Board of Directors. We presently anticipate that our 2003 capital expenditure requirements will range from $30-$35 million. We believe that our current cash and short-term investments, cash generated from operations and funds available from our revolving line of credit will be sufficient to finance our operations, development and capital expenditures for at least the next 12 months. In the event we engage in future acquisitions, including the acquisition of our own common stock, we may have to raise additional capital through additional borrowings or the issuance of debt or equity securities. Adequate funds for these purposes may not be available when needed or on terms acceptable to us, and we may need to raise capital that may not be available on terms favorable or acceptable to us, if at all. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may include restrictive covenants. If we cannot raise more money when needed, we may have to reduce our capital expenditures, scale back our development of new products or reduce our workforce.
In November 2001, we signed a perpetual license agreement with American BioScience, Inc. under which we acquired the exclusive rights to market and sell ABI-007 in North America for indications relating to breast, lung, ovarian, prostate and other cancers. Under the agreement, we made an initial payment to American BioScience of $60.0 million and committed to future milestone payments contingent upon achievement of specified regulatory and sales objectives for licensed indications. American BioScience is responsible for conducting clinical studies in support of ABI-007 and for substantially all costs associated with the development and obtaining regulatory approval for ABI-007, except that we provided $2.0 million of ABI-007 for use in clinical trials, the cost of which we charged to research and development expense in 2001. We may receive revenue resulting from this agreement only after our launch of ABI-007 in North America, which will not occur until after FDA approval is obtained. Even though we anticipate that American BioScience will complete its filing of the NDA for ABI-007 for metastatic breast cancer by the end of 2003, we cannot predict when the FDA will complete its review of the filing, or when or if the NDA may be approved. Any resulting profit would be shared equally between American BioScience and us.
The terms of the license agreement were negotiated to reflect the $60.0 million value of the licensed product rights acquired, then in late-stage development, the value of American BioScience’s remaining obligation to complete the NDA filing and the value of potential sales of the product under other licensed clinical indications. The license agreement was a product of several months of extensive negotiation with American BioScience involving outside counsel, investment banks and a nationally recognized valuation firm. Based upon the analysis and recommendations of our advisors, we believe that the overall terms of the agreement were fair to us and within parameters of similar licenses between unrelated parties. The agreement was unanimously approved by the disinterested members of our Board of Directors with those directors who also have an affiliation with American BioScience recusing themselves from the vote. There are no restrictions on how American BioScience would use payments made under the license agreement and we understand such payments have been and will be used both to fund the development of ABI-007 in relation to our licensed product rights and for other purposes.
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In December 2001, upon completion of our initial public offering, we recorded an initial payment to American BioScience of $60.0 million. In our financial statements, the license agreement was accounted for as an asset contributed by a principal shareholder using the shareholder’s historical cost basis which was zero, and the $60.0 million payment was accounted for as a distribution of stockholders’ equity. Because there was no corresponding charge to income, the income tax benefit of this payment is being credited to stockholders’ equity as realized. For income tax purposes, the payment was recorded as an asset and is being amortized over a 15-year period.
Future milestone payments which will be earned upon achievement of regulatory events prior to FDA approval for each licensed indication will be expensed as achieved, while regulatory milestone payments earned upon FDA approval of those indications will be capitalized and amortized over the expected life of the product. Any future sales based milestone payments will be expensed in the period in which the sales milestone is achieved.
With respect to the first potential ABI-007 indication being studied, metastatic breast cancer, we will be required to pay American BioScience $10.0 million within 30 days of FDA acceptance for filing of an NDA for this indication, meaning that the FDA has found the NDA complete on its face in all respects. Upon FDA approval of the NDA for metastatic breast cancer, we will be required to pay American BioScience an additional $15.0 million. The $10.0 million payment upon FDA acceptance of filing will be expensed in the period of FDA acceptance while the $15.0 million payment related to FDA approval will be capitalized and amortized over the expected life of the product, subject to periodic review for impairment. Regulatory achievements related to other licensed indications under study, including lung, ovarian and prostate cancers, will trigger further milestone payments to American BioScience, but only after ABI-007 has received NDA approval related to the breast cancer indication. Such payments generally total $17.5 million per agreed indication. As with the indication of breast cancer, those payments earned prior to FDA approval for each indication will be expensed, while amounts earned upon FDA approval of those indications will be capitalized and amortized over the expected life of the product. We have the option not to make one or more of the milestone payments tied to indications under study if, following breast cancer approval, sales of the product do not meet specified levels.
Subsequent to FDA approval of ABI-007 and upon achievement of major annual ABI-007 sales milestones, we would be required to make additional payments which, in the aggregate, could total $110.0 million should annual ABI-007 sales exceed $1.0 billion. The first sales milestone payment of $10.0 million would be triggered upon achievement of annual calendar year ABI-007 sales in excess of $200.0 million. Sales milestone payments will be expensed in the period in which the sales milestone is achieved.
Under the license agreement, any profit on ABI-007 net sales in North America would be shared equally between American BioScience and us. The license agreement defines profit as ABI-007 net sales in North America less cost of goods sold, selling expenses (including pre-launch production and marketing expenses which we will expense as incurred, but which will be accumulated and charged against first profit under the agreement) and an allocation of related general and administrative expenses. We will expense American BioScience’s share of any profit earned in our statements of income. Any costs and expenses related to product recalls and product liability claims generally will be split equally between American BioScience and us and expensed as incurred.
In November 2001, along with the license agreement for ABI-007, we also entered into a manufacturing agreement with American BioScience under which we agreed to manufacture ABI-007 for American BioScience and its licensees for sales outside North America. Under this agreement, we have the exclusive right to manufacture ABI-007 for sales in North America for a period of three years and the non-exclusive right to manufacture ABI-007 for sales (a) outside North America and (b) in North America after expiration of the three year exclusivity period. We will charge American BioScience and its licensees a customary margin on our manufacturing costs based on whether the product will be used for clinical trials or commercial sale. The initial term of this agreement is ten years and may be extended for successive two-year terms by American BioScience.
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Forward Looking Information
As of the date of this filing, we continue to project full-year 2003 net sales to increase approximately 20% over 2002 levels. Due to a combination of our marketing success across our product portfolio and slower than expected price erosion for certain products, we have revised our second-half gross margin expectations upward. Based on present market variables, we now expect that second-half gross margin will be in the low 50% range, as compared to previous guidance which was in the 45-50% range.
American BioScience commenced the ABI-007 NDA filing process as planned in the second quarter, submitting completed preclinical and Chemistry Manufacturing and Control sections of the NDA under the Fast Track provision granted to ABI-007 by the FDA. We believe that American BioScience’s accumulation and review of the clinical data for the completed Phase III pivotal trial is on track to complete the entire NDA submission by the end of 2003. In the interim we have been performing scale-up and other work associated with the manufacture of ABI-007. We will be required to pay American BioScience a $10.0 million milestone payment within 30 days of FDA acceptance for filing of an ABI-007 NDA, meaning that the FDA found the NDA complete on its face in all respects. The $10.0 million milestone payment would be expensed in the period the FDA accepts the NDA for filing.
During 2003, we are implementing an ABI-007 specific marketing initiative consisting of a sales and marketing group focused on oncology customers and markets. The dedicated sales and marketing group will ultimately include approximately 100 sales representatives, the majority of whom would be hired in the three to four months prior to launch. We currently estimate that pre-launch sales, marketing and manufacturing start-up expenses (excluding milestone payments of $10.0 million upon FDA acceptance of filing and $15.0 million upon FDA approval) will approximate $15.0 million. We also anticipate that we would begin production of commercial launch quantities during the second half of 2003, which will require the acquisition of an additional $15 to $20 million of paclitaxel inventory during that period.
We may receive revenue resulting from this agreement only after our launch of ABI-007 in North America, which will not occur until after FDA approval is obtained. Even though we anticipate that American BioScience will complete its filing of the NDA for ABI-007 for metastatic breast cancer by the end of 2003, we cannot predict when the FDA will complete its review of the filing or when or if the NDA may be approved. Any resulting profit would be shared equally between American BioScience and us.
If regulatory approval of ABI-007 for metastatic breast cancer in the United States is not obtained, we do not believe there will be any material accumulated adverse impact on earnings or cash flow as marketing and pre-launch costs (excluding inventory) are being expensed as incurred and we would not be required to make any future payments for the achievement of regulatory milestones for any other indication. In addition, we anticipate that we would be able recover a substantial portion of our investment in paclitaxel raw material inventory if regulatory approval of ABI-007 for metastatic breast cancer is not obtained; however, we expect that we would have to write-off our ABI-007 finished goods inventory, of which we currently have none.
We are a majority owned subsidiary of American BioScience. American BioScience is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic compounds including ABI-007 and a variety of biologically active molecules, already existing within the human biological system, for the treatment of life-threatening diseases. American BioScience’s employees, administration and research facilities are independent, separate and distinct from our operations. Except for our President, Chief Executive Officer and Chairman of our Board of Directors, Patrick Soon-Shiong, M.D., no full time employee of American BioScience is also an employee of ours. Even though Dr. Soon-Shiong is also the president, chief financial officer and a director of American BioScience, we believe that compensation paid to Dr. Soon-Shiong by us is commensurate with his duties to us.
Under the license agreement, American BioScience is responsible for conducting clinical studies in support of ABI-007 and for substantially all costs associated with the development and obtaining regulatory approval for ABI-007, for each indication licensed to us. Other than the $2.0 million of ABI-007 that we provided American BioScience in 2001 for use in clinical trials, we have no further obligation under the license agreement for the development or regulatory approval of ABI-007. Due to the multiple ABI-007 indications which we license, American BioScience’s obligations under the license agreement will be ongoing and we cannot predict when American BioScience will be able to complete the development and regulatory approval of each of these indications. We anticipate that American BioScience will complete the filing of the NDA for the first indication for which it has an obligation, metastatic breast cancer, by the end of 2003.
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American BioScience began research and development work on its nanoparticle drug delivery platform, including ABI-007, in 1994. Prior to execution of the license agreement, American BioScience had completed multiple pre-clinical animal studies, two Phase I human studies and two Phase II clinical studies. After execution of the license agreement, American BioScience completed a single Phase III clinical study in metastatic breast cancer as a basis for FDA approval and is in the process of accumulating the data of this Phase III study, which we anticipate to be unblinded and evaluated in the 3rd and 4th quarters of 2003. In June 2003, American BioScience began the ABI-007 NDA filing process with the pre-submission of the pre-clinical and Chemistry, Manufacturing and Control sections of the NDA under the Fast Track designation granted ABI-007 by the FDA earlier this year, and anticipates completion of the entire filing in 2003. American BioScience is also conducting a Phase II clinical trial to explore a weekly dosing regimen of ABI-007 in metastatic breast cancer patients in which prior taxane therapy failed and is evaluating ABI-007 in non-small cell lung, ovarian, melanoma and cervical cancers, the rights to which we have licensed. The results of these Phase I, II and III clinical studies will be used in support of American BioScience’s ABI-007 NDA filing for indications and uses licensed to us by American BioScience, but this data may also support products currently in development by American BioScience for which we did not acquire any rights under the license agreement.
Recent Accounting Pronouncements
In January 2003, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 46, Consolidation of Variable Interest Entities, an Interpretation of Accounting Research Bulletin No. 51 (“FIN 46”). FIN 46 requires consolidation, beginning July 1, 2003, of entities in which we absorb a majority of the entity’s expected losses, receive a majority of the entity’s expected residual returns, or both, as a result of ownership, contractual or other financial interests in the entity. Currently, entities are consolidated when the company has a controlling financial interest through ownership of a controlling voting interest in an entity.
We hold a 50% ownership interest in Drug Source Company, a joint venture with three other partners to purchase raw materials for resale to pharmaceutical companies, including ourselves. We will continue to account for our investment in Drug Source Company under the equity method. Accordingly, FIN 46 will not have a material impact on our financial statements or results of operations.
In addition, during the three months ended June 30, 2003 the FASB issued two new standards. We do not believe that either of these new standards will have a material impact on our financial condition or results of operations.
Statement of Financial Accounting Standards No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging Activities, was issued in April 2003. This statement amends and clarifies financial accounting and reporting for hedging activities and for derivative instruments (including certain derivative instruments embedded in other contracts.) These changes are intended to improve financial reporting by requiring contracts with comparable characteristics to be accounted for similarly. This statement is effective for contracts entered into or modified after June 30, 2003.
Statement of Financial Accounting Standards No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, was issued in May 2003. This statement establishes standards for clarifying and measuring certain financial instruments with characteristics of both liabilities and equity. It requires that an issuer classify a financial instrument that is within its scope as a liability. Many of those instruments could previously be classified as equity. This statement is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our activities without increasing risk. Some of the securities that we invest in may have interest rate risk. This means that a change in prevailing interest rates may cause the fair value of the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the prevailing rate and the prevailing rate later rises, the fair value of the principal amount of our investment will probably decline.
To minimize this risk, we intend to maintain an investment portfolio of cash equivalents and short-term investments consisting of high credit quality securities, including commercial paper, government and non-government debt securities and money market funds. We do not use derivative financial instruments. The average maturity of the debt securities in which we invest has been less than 90 days and the maximum maturity has been three months. Because our investments are diversified and are of a short-term nature, a hypothetical one or two percentage point change in interest rates would not have a material effect on our consolidated financial statements.
We have operated primarily in the United States and the majority of our activities outside the United States to date have been conducted in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency exchange rate fluctuations.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
Based on their evaluation of our disclosure controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934) as of a date within 90 days of the filing date of this Quarterly Report on Form 10-Q, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and are operating in an effective manner.
(b) Changes in internal controls.
There were no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the date of their most recent evaluation.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may be involved in claims and legal proceedings that arise in the ordinary course of business. We are currently party to several such claims and legal proceedings. We do not believe that the resolution of these proceedings will have a material adverse effect on our business, our consolidated financial position or results of operations.
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ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
On December 14, 2001, we completed our initial public offering of 9,000,000 shares of common stock at a public offering price of $16.00 per share realizing an aggregate offering price of $144.0 million. We received proceeds of $133.9 million, net of $10.1 million in underwriting discounts and commissions. We used $37.7 million of the proceeds to repay in full and terminate our term loan and to repay amounts outstanding under the prior revolving credit facility. In addition, we incurred expenses of $2.9 million relating to the issuance and distribution of the securities sold.
On January 10, 2002, the underwriters for our initial public offering exercised in full their option to purchase an additional 1,350,000 shares of our common stock at the initial public offering price of $16.00 per share in order to cover over-allotments. As a result of this exercise, we received proceeds of $20.1 million, net of underwriting discounts and commissions of $1.5 million.
For the year ended December 31, 2002, $55.0 million of the proceeds from our initial public offering, along with $5.0 million of cash generated from operations, for a total of $60.0 million paid in January, 2002, was used to acquire the ABI-007 license, and $9.0 million of the net proceeds was used for general corporate purposes. Under the ABI-007 license agreement, we acquired the exclusive rights to market and sell ABI-007 in North America. On July 29, 2002, we used $14.9 million of the net proceeds from our public offering, and a like amount of cash generated from operations, to repurchase our common stock from Premier Purchasing Partners, L.P.
During the first quarter of 2003, we used an additional $20.0 million of the proceeds from our initial public offering to repurchase 1,064,055 shares of our common stock on the open market under the repurchase program authorized by our Board of Directors in December 2002.
We intend to use the remaining net proceeds for general corporate purposes, including working capital, capital expenditures, and potential acquisitions and licensing opportunities. At this time, we do not have any commitments or agreements with respect to any material acquisition.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
At the 2003 Annual Meeting of Stockholders held on April 24, 2003, our stockholders elected seven persons to our Board of Directors and ratified and approved the appointment of Ernst & Young LLP as our independent auditors for the year ending December 31, 2003.
In connection with the election of directors, the shares of common stock present in person or by proxy were voted as follows:
| | For | | Withheld | |
| |
|
| |
|
| |
Patrick Soon-Shiong, M.D. | | | 43,840,160 | | | 2,136,782 | |
Derek J. Brown | | | 44,035,448 | | | 1,941,494 | |
Jeffrey M. Yordon | | | 44,035,248 | | | 1,941,694 | |
David S. Chen, Ph.D. | | | 45,874,823 | | | 102,119 | |
Stephen D. Nimer, M.D. | | | 45,874,823 | | | 102,119 | |
Leonard Shapiro | | | 45,874,823 | | | 102,119 | |
Kirk K. Calhoun | | | 45,874,823 | | | 102,119 | |
All of the directors elected at the 2003 Annual Meeting of Stockholders were incumbent directors whose term of office continued after the meeting.
In connection with the proposal to approve the ratification and approval of the appointment of Ernst & Young LLP as our independent auditors for the year ending December 31, 2003: 45,950,963 shares were voted in favor of the proposal, 14,972 shares were voted against the proposal, and holders of 11,007 shares abstained.
There were no broker non-votes with respect to either of the above matters.
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
| 31.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as required by Section 302 of the Sarbanes-Oxley Act of 2002. |
| | | |
| 31.2 | | Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as required by Section 302 of the Sarbanes-Oxley Act of 2002. |
| | | |
| 32.1 | | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as added by Section 906 of the Sarbanes-Oxley Act of 2002. |
| | | |
| 32.2 | | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as added by Section 906 of the Sarbanes-Oxley Act of 2002. |
(b) Reports on Form 8-K
| On April 24, 2003, we filed a Current Report on Form 8-K under Items 7 and 9 with the Securities and Exchange Commission to furnish information regarding our preliminary results for the first quarter ended March 31, 2003. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
| AMERICAN PHARMACEUTICAL PARTNERS, INC. |
| |
| By: | /s/ PATRICK SOON-SHIONG | |
| |
| |
| | Patrick Soon-Shiong, M.D. Chief Executive Officer and President (Principal Executive Officer) | |
| | | |
| By: | /s/ NICOLE S. WILLIAMS | |
| |
| |
| | Nicole S. Williams Executive Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) | |
Date: August 13, 2003
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