The Company generated $3,572,000 of other revenues in the 2004 period compared to $966,000 in the 2003 period. Other revenue for the 2004 period included $2,500,000 from Teva, which represented the reversal of a portion of the refundable deposit for its exercise of the exclusivity option for certain products.
The balance of $1,072,000 of other revenue represents revenues recognized pursuant to strategic agreements with Schering-Plough, Wyeth, and Novartis. These amounts represent the amortization of the milestone payments received by the Company, over the life of the agreement. The following table summarizes the activity in net revenues for the six months ended June 30, 2004 and 2003:
The rebates, chargebacks, returns and other credits decreased for the six months ended June 30, 2004 to approximately 17% of product sales as compared to approximately 24% for the comparable period in 2003. This decrease was mainly due to Bupropion Hydrochloride 100 mg and 150 mg Controlled Release Tablets, Loratadine and Pseudoephedrine Sulfate (5mg/120mg) 12-hour Extended Release Tablets, which are exempt from rebates, chargebacks and other credits as per the agreements with Teva, Schering-Plough, Wyeth, and Novartis. The following table summarizes the net sales for the six months ended June 30, 2004 as compared to the six months ended June 30, 2003 by marketing channel:
The increase in Global products of approximately $9 million in the first six months of 2004 as compared to the same period in 2003 was primarily due to new products introduced in 2004 and late 2003, such as Demeclocycline of approximately $4.9 million, Flavoxate of approximately $1.4 million, Carbidopa/Levodopa of approximately $0.8 million, and higher sales of previously introduced products, such as Orphenadrine, of approximately $0.8 million, and LIPRAM products of approximately $0.8 million.
The cost of sales for the six months ended June 30, 2004, was $37,087,000 as compared to $17,468,000 for the same period in 2003. The overall increase in cost of sales was primarily due to the increase in cost of materials as a result of increased product sales.
Gross margin for the six months ended June 30, 2004 was $32,611,000, or approximately 46.8% of total revenues, as compared to $8,024,000, or approximately 31.5% of total revenues, for the same period in 2003. The year-over-year increase in the gross margin percentage was primarily due to the introduction of new products since last year with higher margins, such as Bupropion Hydrochloride, Demeclocycline Hydrochloride, Flavoxate, and Carbidopa/Levodopa, and the $2,500,000 revenue from Teva related to the refundable deposit.
Back to Contents
Research and Development Expenses
The research and development expenses for the six months ended June 30, 2004 were $9,810,000 less reimbursements of $89,000 by a subsidiary of Teva Pharmaceutical Industries, Ltd. under the Strategic Alliance Agreement signed in June 2001, as compared to $7,006,000 less reimbursements of $154,000 for the same period in 2003. The higher research and development expenditures in 2004 as compared to 2003 were attributable to higher personnel costs, biostudies, clinical studies, and new product introduction costs.
Patent and Patent Litigation Expenses
The patent and patent litigation expenses for the six months ended June 30, 2004 were $4,361,000 as compared to $1,096,000 for the same period in 2003. The year-to-year increase for the six months was primarily due to the ongoing Paragraph IV litigation related to our Omeprazole Capsules and Fenofibrate Tablets ANDAs.
Selling Expenses
The selling expenses for the six months ended June 30, 2004 were $1,437,000 as compared to $1,006,000 for the same period in 2003. The increase in selling expenses as compared to 2003 was primarily due to higher personnel costs.
General and Administrative Expenses
The general and administrative expenses for the six months ended June 30, 2004 were $6,468,000 as compared to $4,205,000 for the same period in 2003. The increase in general and administrative expenses as compared to 2003 was primarily due to higher professional fees, insurance premiums, and personnel costs.
Interest Income
Interest income for the six months ended June 30, 2004 was $327,000 as compared to $112,000 for the same period in 2003, primarily due to higher average cash equivalents and short-term investments generated from the net proceeds of the Company’s $95 million convertible senior subordinated debentures.
Interest Expense
Interest expense for the six months ended June 30, 2004 was $836,000 as compared to $495,000 for the same period in 2003. The increase in interest expense for 2004 was primarily due to the 1.25% interest accrued on the Company’s $95 million convertible senior subordinated debentures.
Income Taxes
For the six months ended June 30, 2004, the Company provided for income taxes of $506,000 or 5% of income before taxes, as compared to $0 for the 2003 period. The effective tax rate in 2004 reflects the partial reversal of the deferred income tax asset valuation allowance recognized. The valuation allowance was reduced to reflect the utilization of federal and state loss carryforwards that offset the current tax component of the income tax provision. We evaluate the realizability of deferred tax assets on an annual and quarterly basis or if there is a significant change in circumstance that may cause a change in our judgment about the realizability of our deferred tax assets. Any valuation allowance that may be released as a result of the evaluation process could have a material effect on our future results of operations. At December 31, 2003, the Company had a net operating loss-carryforward totaling approximately $94,600,000, which expires from 2009 through 2023.
Net Income
The net income for the six months ended June 30, 2004, was $9,620,000 as compared to a net loss of $5,497,000 for the same period in 2003, primarily due to higher sales, partially offset by higher research and development, selling, and general administrative expenses.
Liquidity and Capital Resources
As of June 30, 2004, we had $98,556,000 in cash, cash equivalents and short-term investments. Only $200,000 of the account balances are insured by the Federal Depository Insurance Company (FDIC). The balance of the Company’s cash equivalents and the short-term investments are held in U.S. Treasury securities and high-grade commercial paper, which are not insured by the FDIC.
19
Back to Contents
The net cash provided by financing activities for the six months ended June 30, 2004, was approximately $101,016,000, consisting primarily of the $95,000,000 proceeds, less capitalized costs of $3,612,000, from the Company’s convertible senior subordinated debentures offering completed in April 2004, and proceeds of $3,771,000 from issuance of common stock upon the exercise of options and warrants.
In April 2004, the Company terminated the loan agreements with PIDA and DRPA and repaid the remaining balances totaling approximately $992,000.
For the six months ended June 30, 2004, significant uses of cash from operating activities included, primarily, the increase in accounts receivable balance of $13,455,000 and inventory buildup of $8,623,000, partially offset by favorable cash flow from operations, (excluding depreciation and amortization) of $11,702,000. During the three months ended June 30, 2004, we repaid our partners, Teva and Andrx, approximately $11.8 million for their portion of funding the inventory buildup for the Bupropion Hydrochloride products.
Our capital expenditures for the six months ended June 30, 2004 were $6,269,000 as compared to $1,125,000 for the same period in 2003. The net cash used in investing activities included $45,244,000 for the purchase of the short term investments in U.S. Treasury securities and high-grade commercial paper.
In December 2003, the Company transferred the $25 million Loan and Security Agreement from Congress Financial Corporation to Wachovia Bank, N.A., thereby securing lower interest and less restrictive borrowing terms. The interest rates for the revolving loans are prime rate plus 0.75%, or eurodollar rate plus 2.75%, at our option, based on excess availability. The term loan has an interest rate of prime rate plus 1.5%, or eurodollar rate plus 4%, at our option. As of June 30, 2004, we borrowed approximately $5,000,000 against the revolving credit line and $2,880,000 against the term loan. In April 2004, the $25 million loan and security agreement was amended, as follows: (1) the cash collateral requirement of $10 million was removed; (2) the adjusted excess availability covenant was removed; (3) the maximum permitted capital expenditure amount was aggregated to $45,000,000 for the years 2004 and 2005, and (4) as a condition of items (1) and (2) above, IMPAX is required to maintain a minimum cash balance at Wachovia of $25,000,000.
We have no interest rate or derivative financial instruments nor material foreign exchange risks. We are also not party to any off-balance-sheet arrangements, other than operating leases.
We expect to incur significant operating expenses, particularly research and development, for the foreseeable future in order to execute our business plan. We, therefore, anticipate that such operating expenses, as well as planned capital expenditures for the next twelve months ranging from $18 to $22 million, primarily in plant capacity expansion, will constitute a material use of our cash resources.
To date, we have primarily funded our research and development and other operating activities through equity and debt financing, and strategic alliances.
We have not paid any cash dividends on our common stock and we do not plan to pay any such cash dividends in the foreseeable future. We plan to retain any earnings for the operation and expansion of our business. Our loan agreements prohibit the payment of dividends without the other party’s consent.
Recent Accounting Pronouncements
In January 2003, the FASB issued FASB Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities.” FIN 46 clarifies the application of Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 applies immediately to variable interest entities created after January 31, 2003, and to variable interest entities in which an enterprise obtains an interest after that date. It applies in the first fiscal year or interim period beginning after June 15, 2003, to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. FIN 46 applies to public enterprises as of the beginning of the applicable interim or annual period. On October 8, 2003, the FASB decided to defer FIN 46 until the first reporting period ending after December 15, 2003. The provisions of this Interpretation did not have a material impact on the Company’s financial condition or results of operations.
In December 2003, the FASB issued FIN No. 46R, Consolidation of Variable Interest Entities, clarifying the application of Accounting Research Bulletin No. 51, Consolidated Financial Statements, to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support. The provisions of this Interpretation do not have a material impact on the Company’s financial condition or results of operations.
20
Back to Contents
In December 2003, the FASB revised SFAS 132, “Employers’ Disclosure About Pensions and Other Post Retirement Benefits.” This Statement does not change the measurement or recognition of those plans required by FASB 87, “Employers’ Accounting for Pensions,” and No. 106, “Employers’ Accounting for Post Retirement Benefits Other than Pensions.” This Statement retains the disclosure requirements contained in FASB No. 132, “Employers’ Disclosure about Pensions and Other Post Retirement Plans.” The provisions of this Statement do not have a material impact on the Company’s financial condition or results of operations. During the six months ended June 30, 2004 and 2003, the employer 401-K match was $218,000 and $150,000, respectively.
In February 2004, the FASB issued revised FSP pertaining to FIN 46(R). The revised FSPs replace certain previously issued FIN 46 FSP for entities to which FIN 46(R) is applicable. This revision to FIN 46 did not have a material impact on the Company’s financial condition or results of operation.
In February 2004, the FASB revised SFAS 133, Accounting for Derivative Instruments and Hedging Activities for Implementation issue E2L, A1J, and C6. The revisions to SFAS 133 did not have a material impact on the Company’s financial condition or results of operation.
In June 2004, the FASB discussed EITF 04-08, The Effect of Contingently Convertible Debt on Diluted Earnings Per Share. The EITF task force has proposed that companies count the shares that could be issued upon conversion of securities like the Company’s debentures when calculating fully diluted per share earnings. This EITF is not yet effective. However, we disclosed in Note 2 the potential effect of this EITF on the Company’s fully diluted EPS calculation.
Major Operational Highlights for the Six Months Ended June 30, 2004
• | On January 28, 2004, IMPAX announced that the U.S. Food and Drug Administration (FDA) granted final approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of Wellbutrin® SR (Bupropion Hydrochloride) 100 mg Controlled Release Tablets and granted tentative approval to the Company's generic version of Wellbutrin SR 150 mg Controlled Release Tablets. GlaxoSmithKline markets Wellbutrin SR for the treatment of depression. According to NDCHealth, U.S. sales of these dosage forms of Wellbutrin SR Tablets were approximately $1.2 billion in the twelve months ended June 30, 2004. |
| |
• | On January 29, 2004, IMPAX announced that the Court of Appeals for the Federal Circuit in Washington, D.C. upheld a lower court decision that ruled against certain claims by GlaxoSmithKline in regards to the Company's ANDA for Wellbutrin SR (Bupropion Hydrochloride) 100 mg and 150 mg and for Zyban® (Bupropion Hydrochloride) 150 mg. GlaxoSmithKline markets Wellbutrin SR for the treatment of depression and Zyban for smoking cessation. |
| |
• | On February 27, 2004, IMPAX announced that the FDA granted tentative approval to the Company's ANDA for its generic version of Allegra®-D (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60mg/120mg) Extended Release Tablets. Aventis Pharmaceuticals markets Allegra-D for the treatment of the symptoms associated with seasonal allergic rhinitis. According to NDCHealth, U.S. sales of Allegra-D were approximately $438 million in the twelve months ended June 30, 2004. |
| |
• | On March 5, 2004, IMPAX announced that the FDA granted final approval to the Company's ANDA for a generic version of Claritin®-D 24-Hour (Loratadine and Pseudoephedrine Sulfate, 10mg/240mg) Extended Release Tablets. Schering-Plough Corporation markets Claritin-D 24-Hour as an over-the-counter (OTC) drug for the relief of symptoms of seasonal allergic rhinitis (hay fever). According to NDCHealth, U.S. sales of Claritin-D 24-Hour were $7 million for the twelve months ended June 30, 2004. |
| |
• | On March 8, 2004, IMPAX announced that the FDA granted tentative approval to the Company's ANDA for its generic version of Tricor® (Fenofibrate) Tablets. Tricor Tablets are marketed by Abbott Laboratories, Inc. to assist patients in managing their cholesterol levels. The drug is indicated for use in reducing elevated LDL cholesterol, total cholesterol, triglycerides and Apo B and increasing HDL cholesterol in patients with primary hypercholesterolemia or mixed lipidemia. The drug has also been approved as adjunctive therapy for the treatment of hypertriglyceridemia, a disorder characterized by elevated levels of very low density lipoprotein (VLDL) in the plasma. According to NDCHealth, U.S. sales of Tricor Tablets were approximately $684 million for the twelve months ended June 30, 2004. |
| |
• | On March 22, 2004, IMPAX announced that the FDA granted final marketing approval to the Company's ANDA for its generic version of Wellbutrin SR (Bupropion Hydrochloride) 150 mg Controlled Release Tablets. The FDA had previously granted final approval for the Company's application for the 100 mg strength. GlaxoSmithKline markets Wellbutrin SR for the treatment of depression. Both products were shipped to our marketing partner, Teva. |
21
Back to Contents
• | On March 23, 2004, IMPAX announced that the FDA granted final marketing approval to the Company's ANDA for its generic version of Declomycin® (Demeclocycline Hydrochloride) 150 and 300 mg. Tablets. ESP Pharma markets Declomycin for the treatment of various infections. According to NDCHealth, U.S. sales of Declomycin were approximately $30 million for the twelve months ended June 30, 2004. |
| |
• | On May 17, 2004, IMPAX announced that the FDA granted final approval to the Company's ANDA for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet® CR tablets. Bristol-Myers Squibb markets Merck & Co.'s Sinemet CR exclusively in the U.S. for the treatment of Parkinsonism. According to NDCHealth, U.S. prescription sales of Sinemet CR and the one currently marketed generic equivalent were $123 million in the twelve months ended June 30, 2004. |
| |
• | On May 27, 2004, IMPAX announced that the FDA granted final marketing approval to the Company's ANDA for its generic version of Zyban, Bupropion Hydrochloride 150 mg Controlled Release Tablets. GlaxoSmithKline markets Zyban for smoking cessation. According to NDCHealth, U.S. sales of Zyban were approximately $59 million in the twelve months ended June 30, 2004. |
| |
• | On May 28, 2004, IMPAX announced that the FDA granted final marketing approval to the Company's ANDA for its generic version of Proamatine®, Midodrine Hydrochloride 2.5 and 5 mg Tablets. Shire Pharmaceuticals Group plc markets Proamatine for treatment of symptomatic orthostatic hypotension. According to NDCHealth, U.S. market sales of Proamatine 2.5 mg and 5 mg and the two other marketed generic versions were approximately $48 million in the twelve months ended June 30, 2004. |
| |
• | On June 18, 2004, IMPAX announced that the FDA granted IMPAX a second tier 180-day exclusivity related to its pending ANDA for a generic version of Glucophage XR®, Metformin HCl Extended Release Tablets, 500mg. IMPAX has selectively waived its rights to this exclusivity to Teva Pharmaceuticals USA Inc. and will be sharing in the profits of Teva's Metformin HCl Extended Release Tablets as provided for in the Strategic Alliance Agreement between IMPAX and Teva signed in June 2001. On August 2, 2004, the FDA granted final marketing approval to the Company’s ANDA for its generic version of Glucophage XR, Metformin HCl Extended Release Tablets, 500 mg. Bristol-Myers Squibb markets Glucophage XR for the improvement of glycemic control in patients with type 2 diabetes. According to NDCHealth, U.S. market sales of Glucophage XR 500 mg and other marketed generic versions were approximately $376 million in the twelve months ended June 30, 2004. |
| |
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
The Company’s cash and cash equivalents includes U.S. government and short-term high-grade commercial paper stated at cost which approximates market value. The primary objective of the Company’s investment activities is to preserve principal and maximize yields without significantly increasing risk. To achieve this objective, the Company maintains its portfolio in a variety of high credit quality securities, including U.S. Government securities, treasury bills, and short-term high-grade commercial paper. One hundred percent of the Company’s portfolio matures in less than one year. The carrying value of the portfolio approximates the market value at June 30, 2004. The Company’s debt instruments at June 30, 2004, are subject to fixed and variable interest rates and principal payments. We believe that the fair value of our fixed and variable rate long-term debt approximates their carrying value of approximately $108 million at June 30, 2004. While changes in market interest rates may affect the fair value of our fixed and variable rate long-term debt, we believe the effect, if any, of reasonably possible near-term changes in the fair value of such debt on the Company’s financial statements will not be material.
We have no interest rate or derivative financial instruments nor material foreign exchange risks. We are also not party to any off-balance-sheet arrangements, other than operating leases.
ITEM 4. | CONTROLS AND PROCEDURES |
The Company, under the supervision and with the participation of our management, including our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15[e]), as of the end of the period covered by this report. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures are effective in reaching a reasonable level of assurance that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized, and reported within the time period specified in the Securities and Exchange Commission’s rules and forms. The principal executive officer and principal financial officer also conducted an evaluation of internal control over financial reporting (“Internal Control”) to determine whether any changes in Internal Controls occurred during the quarter that have materially affected, or which are reasonably likely to materially affect, Internal Controls.
Based on this evaluation, there has been no such change during the quarter covered by this report. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. The Company conducts periodic evaluations of its internal controls to enhance, where necessary, its procedures and controls. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
22
Back to Contents
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Patent Litigation
There has been substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new products that are the subject of conflicting patent rights. One or more patents cover most of the brand name controlled-release products for which we are developing generic versions. Under the Hatch-Waxman Amendments, when a drug developer files an ANDA for a generic drug, and the developer believes that an unexpired patent which has been listed with the FDA as covering that brand name product will not be infringed by the developer’s product or is invalid or unenforceable, the developer must so certify to the FDA. That certification must also be provided to the patent holder, who may challenge the developer’s certification of non-infringement, invalidity or unenforceability by filing a suit for patent infringement within 45 days of the patent holder’s receipt of such certification. If the patent holder files suit, the FDA can review and approve the ANDA, but is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered, or 30 months from the date the certification was received, whichever is sooner. Should a patent holder commence a lawsuit with respect to an alleged patent infringement by us, the uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. The delay in obtaining FDA approval to market our product candidates as a result of litigation, as well as the expense of such litigation, whether or not we are successful, could have a material adverse effect on our results of operations and financial position. In addition, there can be no assurance that any patent litigation will be resolved prior to the 30-month period. As a result, even if the FDA were to approve a product upon expiration of the 30-month period, we may not commence marketing that product if patent litigation is still pending.
Lawsuits have been filed against us in connection with fourteen of our Paragraph IV filings. The outcome of such litigation is difficult to predict because of the uncertainties inherent in patent litigation.
AstraZeneca AB et al. v. IMPAX: The Omeprazole Cases
In May 2000, AstraZeneca AB and four of its related companies filed suit against IMPAX in the U.S. District Court in Wilmington, Delaware claiming that IMPAX’s submission of an ANDA for Omeprazole Delayed Release Capsules, 10 mg and 20 mg, constitutes infringement of six U.S. patents relating to AstraZeneca’s Prilosec product. The action seeks an order enjoining IMPAX from marketing Omeprazole Delayed Release Capsules, 10 mg and 20 mg until February 4, 2014, and reimbursement for costs and attorney fees associated with this litigation.
In February 2001, AstraZeneca and the same related companies filed the same suit against IMPAX in the same federal court in Delaware for infringement, based upon IMPAX’s amendment to its ANDA adding 40 mg strength Omeprazole Delayed Release Capsules.
AstraZeneca filed essentially the same lawsuits against nine other generic pharmaceutical companies (Andrx, Genpharm, Cheminor, Kremers, LEK, Eon, Mylan, Apotex, and Zenith). Due to the number of these cases, a multidistrict litigation proceeding, In re Omeprazole 10 mg, 20 mg, and 40 mg Delayed Released Capsules Patent Litigation, MDL-1291, has been established to coordinate pre-trial proceedings. Both lawsuits filed by AstraZeneca against IMPAX have been transferred to the multidistrict litigation.
Early in the multidistrict litigation, the trial court ruled that one of the six patents-in-suit was not infringed by the sale of a generic omeprazole product and that certain other patents were invalid. These rulings effectively eliminated four patents from the trial of these infringement cases, although AstraZeneca may appeal these rulings as part of the overall appeal process in the case.
On October 11, 2002, after a trial involving Andrx, Genpharm, Cheminor, and Kremers, the trial judge handling the multidistrict litigation ruled on AstraZeneca’s complaints that three of these four defendants (First Wave Defendants) infringed the remaining patents-in-suit. The trial judge ruled that three of the First Wave defendants, Andrx, Genpharm, and Cheminor, infringed the remaining two patents asserted by AstraZeneca in its complaints, and that those patents are valid until 2007. In the same ruling, the trial court ruled that the remaining First Wave Defendant, Kremers, did not infringe either of the remaining two patents. This defendant’s formulation differed from the formulation used by the other First Wave Defendants in several respects. In mid-December 2003, the U.S. Court of Appeals for the Federal Circuit affirmed the October 2002 ruling in all respects. Subsequent petitions for rehearing have been denied.
23
Back to Contents
The formulation that IMPAX would employ in manufacturing its generic equivalent of omeprazole has not been publicly announced. IMPAX’s formulation has elements that resemble those of other First Wave Defendants, but it also has elements that differ. Although the ruling by the trial court in the multidistrict litigation has a significant effect on the course of AstraZeneca’s litigation against IMPAX, application of the trial court’s opinion is not certain. IMPAX believes that it has defenses to AstraZeneca’s claims of infringement, but the opinion rendered by the trial court in the First Wave cases makes the outcome of AstraZeneca’s litigation against IMPAX uncertain.
Two of the remaining six defendants (Second Wave Defendants) filed Motions for Summary Judgment of Non-Infringement, based upon the October 2002 ruling. The trial court has deferred ruling on those motions until discovery is completed.
In December 2003, the trial court entered a new scheduling order governing pre-trial proceedings relating to the Second Wave Defendants, including IMPAX. The schedule for completion of the litigation in the Second Wave, including AstraZeneca's litigation against IMPAX, now provides that all fact discovery (with certain exceptions) is complete. AstraZeneca's expert reports on issues as to which it bears the burden of proof, including issues of alleged infringement, were produced on February 17, 2004. IMPAX's responsive expert reports were produced on July 12, 2004.
Under the December 2003 scheduling order, Astra's reply reports would have been due on August 6, 2004, and expert depositions would have commenced shortly thereafter. Following receipt of IMPAX's six expert reports on July 12, 2004, as well as 17 other reports produced by four other defendants, Astra requested a further modification of the scheduling order. Astra's request for a three-month extension of the time for its reply reports was denied, but the Court granted Astra an additional five-week period to respond to the defendants' rebuttal reports on non-infringement. The schedule for expert depositions must be re-established. Nevertheless, expert depositions will be conducted between September 14, 2004, when reply reports are now due, and the end of 2004. Given the delays which have thus far occurred in the litigation and the number of experts already designated by the parties, it is uncertain whether the expert depositions can be completed in the time allotted by the present schedule.
Under the December 2003 schedule, Motions for Summary Judgment may not be filed, as of right, until October 19, 2004. IMPAX has recently requested permission to file an earlier motion for summary judgment on one aspect of the case. Other defendants have also requested permission to file early motions for summary judgment on other aspects of the litigation.
IMPAX may file additional Motions for Summary Judgment, including other Motions for Summary Judgment of Non-Infringement, following the close of all discovery or after October 19, 2004, whichever comes first. If the case is not resolved by summary judgment, the case involving IMPAX will be returned to the U.S. District Court in Delaware for trial. It is likely, given the proceedings in the First Wave cases, that the case against IMPAX will be transferred back to New York for a consolidated trial before the same judge who decided the First Wave cases. IMPAX believes, however, that any trial that might be scheduled in the case will commence in the first half of 2005.
If IMPAX does not file a Motion for Summary Judgment, or if such a Motion is denied, the court will schedule a date for trial. IMPAX intends to vigorously defend the action brought by AstraZeneca.
In August 2003, the court issued an order dismissing four of the patents-in-suit, three with prejudice. On September 30, 2003, as a result of the court’s dismissal, AstraZeneca served each of the Second Wave Defendants, including IMPAX, with an amended complaint. In October 2003, IMPAX filed an answer to the amended complaint in which we asserted a new counterclaim with antitrust allegations. The counterclaim will be severed, and proceedings relating to it will be stayed until after trial of the patent infringement case.
Aventis Pharmaceuticals Inc., et al. v. IMPAX: The Fexofenadine Cases
On March 25, 2002, Aventis Pharmaceuticals Inc., Merrell Pharmaceuticals Inc., and Carderm Capital L.P. (collectively referred to as Aventis) sued IMPAX in the U.S. District Court for the District of New Jersey (Civil Action No. 02-CV-1322) alleging that IMPAX’s proposed fexofenadine and pseudoephedrine hydrochloride tablets, containing 60 mg of fexofenadine and 120 mg of pseudoephedrine hydrochloride, infringe U.S. Patent Nos. 6,039,974; 6,037,353; 5,738,872; 6,187,791; 5,855,912; and 6,113,942. On November 7, 2002, Aventis filed an amended complaint, which added an allegation that IMPAX’s Fexofenadine and Pseudoephedrine Hydrochloride 60 mg/120 mg Extended Release Tablet product infringes U.S. Patent No. 6,399,632. Aventis seeks an injunction preventing IMPAX from marketing its Fexofenadine and Pseudoephedrine Hydrochloride 60 mg/120 mg Extended Release Tablet product until the patents-in-suit have expired, and an award of damages for any commercial manufacture, use, or sale of IMPAX’s Fexofenadine and Pseudoephedrine Hydrochloride 60 mg/120 mg Extended Release Tablet product, together with costs and attorneys’ fees.
24
Back to Contents
Fact discovery in this action is scheduled to close on October 29, 2004. IMPAX believes that it has defenses to the claims made by Aventis based on noninfringement and invalidity. A tentative trial date has been scheduled for October 2005.
Aventis has also filed a suit against Barr Laboratories, Inc., Mylan Pharmaceuticals, Inc., Dr. Reddy’s Pharmaceuticals and Teva Pharmaceuticals USA, Inc. in New Jersey asserting the same patent infringement against these defendants’ proposed Fexofenadine and Pseudoephedrine or Fexofenadine products. The IMPAX case has been consolidated for trial with the Barr, Mylan, Dr. Reddy and Teva cases.
On March 25, 2004, Aventis and AMR filed a complaint and first amended complaint against IMPAX and Ranbaxy, alleging infringement of two additional patents relating to the process for making the active pharmaceutical ingredient, fexofenadine hydrochloride. These patents, United States Patent Nos. 5,581,011 and 5,750,703, are owned by AMR and exclusively licensed to Aventis.
On July 23, 2003, IMPAX filed Summary Judgment motions for non-infringement of U.S. Patent Nos. 6,039,974, 6,113,942, and 5,855,912; and for non-infringement and invalidity of U.S. Patent No. 5,738,872. Opposition papers were filed on August 11, 2003. Reply papers were filed on September 24, 2003. On October 24, 2003, IMPAX filed a brief discussing the impact of the recent Festo decision on their Motions for Summary Judgment of non-infringement. Oral argument for the Summary Judgment Motion regarding the ‘912, ‘942, and ‘974 patents was heard on November 3, 2003. Oral argument for the Summary Judgment Motion regarding the ‘872 patent was heard on December 8, 2003. On June 29, 2004, the court granted the Company’s Motions for Summary Judgment of Non-infringement of the ‘912 and ‘942 patents and denied the Company’s Motion for Summary Judgment of Non-infringement of the ‘974 patent. At the same time, the court ordered that a ruling on the Company’s motion for Summary Judgment for the Non-infringement of the ‘872 patent is reserved pending a Markman hearing to be held on September 9, 2004 to assist the court in construing the patent’s product-by-process claims.
Purdue Pharma L.P. et al. v IMPAX: The Oxycodone Cases
On April 11, 2002, Purdue Pharma and related companies filed a complaint in the U.S. District Court for the Southern District of New York alleging that IMPAX’s submission of ANDA No. 76-318 for 80 mg OxyContin Tablets infringes three patents owned by Purdue. The Purdue patents are U.S. Patent Nos. 5,508,042, 5,549,912 and 5,656,295; all directed to controlled release opioid formulations. On September 19, 2002, Purdue filed a second Infringement Complaint regarding IMPAX’s 40 mg OxyContin generic product. On October 9, 2002, Purdue filed a third Infringement Complaint regarding IMPAX’s 10 mg and 20 mg OxyContin generic products. IMPAX filed its answer and counterclaims in each case on October 3, 2003. On November 25, 2003, Purdue submitted their reply to our counterclaims. Purdue is seeking, among other things, a court order preventing IMPAX from manufacturing, using or selling any drug product that infringes the subject Purdue patents.
Purdue previously sued Boehringer Ingelheim/Roxane, Endo and Teva on the same patents. One or more of these defendants may resolve the invalidity issues surrounding the Purdue patents prior to when IMPAX’s case goes to trial. The Boehringer Ingelheim/Roxane suit is stayed. The Endo action was tried in June 2003 and post trial briefs have been filed. In January 2004, the judge in the Endo action ruled that the three patents in suit, the same patents that Purdue had asserted against IMPAX, are unenforceable because they were inequitably procured and enjoined their enforcement. Purdue has appealed that ruling to the Court of Appeals for the Federal Circuit.
IMPAX v. Aventis Pharmaceuticals, Inc.: The Riluzole Case
In June 2002, IMPAX filed suit against Aventis Pharmaceuticals, Inc. in the U.S. District Court in Wilmington, Delaware, seeking a declaration that the filing of an ANDA to engage in a commercial manufacture and/or sale of Riluzole 50 mg Tablets for treatment of patients with amyotrophic lateral scleroses (ALS) does not infringe claims of Aventis’ U.S. Patent No. 5,527,814 (‘814 patent) and a declaration that this patent is invalid.
In response to IMPAX’s complaint, Aventis filed counterclaims for direct infringement and inducement of infringement of the ‘814 patent. In December 2002, the district court granted Aventis’ Motion for Preliminary Injunction and enjoined IMPAX from infringing, contributory infringing, or inducing any other person to infringe Claims 1, 4 or 5 of the ‘814 patent by selling, offering for sale, distributing, marketing or exporting from the United States any pharmaceutical product or compound containing riluzole or salt thereof for the treatment of ALS.
25
Back to Contents
The trial was completed on October 30, 2003, and post-trial briefing was completed in December 2003. IMPAX is pursuing its assertions that claims of the ‘814 patent are invalid in view of prior art and are unenforceable in view of inequitable conduct committed during the prosecution of the patent before the United States Patent and Trademark Office (USPTO).
On January 30, 2004, the court denied IMPAX’s Motion for Summary Judgment on inequitable conduct and, on February 5, 2004, the court denied IMPAX’s Motion for Summary Judgment on non-infringement of certain claims. The court has not issued its trial rulings and did not rule on the third pre-trial Motion for Summary Judgment based on invalidity of the patent-in-suit.
If IMPAX is not ultimately successful in proving invalidity or unenforceability, there is a substantial likelihood that the court will enter a permanent injunction enjoining IMPAX from marketing Riluzole 50 mg Tablets for the treatment of ALS in the United States until the expiration of the ‘814 patent (June 18, 2013). If IMPAX is ultimately successful in proving either defense, the preliminary injunction would be set aside and IMPAX would be permitted to market its Riluzole 50 mg Tablet product for the treatment of ALS in the United States.
Abbott Laboratories v. IMPAX: The Fenofibrate Tablet Cases
In January 2003, Abbott Laboratories and Fournier Industrie et Sante and a related company filed suit against IMPAX in the U.S. District Court in Wilmington, Delaware claiming that IMPAX’s submission of an ANDA for Fenofibrate Tablets, 160 mg, constitutes infringement of two U.S. patents owned by Fournier and exclusively licensed to Abbott, relating to Abbott’s Tricor tablet product.
In March 2003, Abbott and Fournier filed a second action against IMPAX in the same court making the same claims against IMPAX’s 54 mg Fenofibrate Tablets. These cases were consolidated in April 2003.
In September 2003, Abbott and Fournier filed a third action against IMPAX in the U.S. District Court in Wilmington, Delaware, claiming that IMPAX’s submission of its ANDA for 54 mg and 160 mg Fenofibrate Tablets constitutes infringement of a third patent recently issued to Fournier and exclusively licensed to Abbott. This action was also consolidated with the two previously consolidated actions in December 2003. In January 2004, Abbott and Fournier filed a fourth action relating to IMPAX’s 54 mg and 160 mg Fenofibrate Tablets based upon a claim of infringement of a fourth patent. All four cases were consolidated in March 2004. Fact and expert discovery in the consolidated cases closes in November 2004 and the trial is currently set for June 2005. IMPAX has responded to all four complaints by asserting that its proposed generic Fenofibrate Tablet products do not infringe the patents-in-suit and by asserting that the patents-in-suit are invalid.
All four actions seek an injunction preventing IMPAX from marketing its Fenofibrate Tablet products until the expiration of the patents (January 9, 2018) and an award of damages for any commercial manufacture, use, or sale of IMPAX’s Fenofibrate Tablet product, together with costs and attorney fees.
Solvay Pharmaceuticals v. IMPAX: The Creon Case
On April 11, 2003, Solvay Pharmaceuticals, Inc., manufacturer of the Creon line pancreatic enzyme products, brought suit against IMPAX in the U.S. District Court for the District of Minnesota claiming that IMPAX has engaged in false advertising, unfair competition, and unfair trade practices under federal and Minnesota law in connection with the Company’s marketing and sale of its Lipram products. The suit seeks actual and consequential damages, including treble damages, attorneys’ fees, injunctive relief and declaratory judgments that would prohibit the substitution of Lipram for prescriptions of Creon. On June 6, 2003, IMPAX filed a Motion for Dismissal of Plaintiff’s Complaint, which sought to dismiss each count of Solvay’s complaint. On January 9, 2004, the U.S. District Court issued a ruling on IMPAX’s Motion for Dismissal, dismissing two of the counts set forth in the Complaint, including the count which sought a declaratory judgment that Lipram may not lawfully be substituted for prescriptions of Creon. On January 26, 2004, IMPAX filed its Answer to the Complaint and Counterclaim alleging that Solvay wrongfully interfered with IMPAX’s business relationships. On February 17, 2004, Solvay filed its Reply to IMPAX’s Counterclaim. On February 24, 2004, the Rule 16 Scheduling Conference was held and, on February 25, 2004, the Court issued a Scheduling Order setting the deadline for discovery on January 14, 2005, and a trial date for July 1, 2005. Fact discovery is currently ongoing in this case. IMPAX believes it has defenses to Solvay’s allegations and intends to pursue these defenses vigorously.
Alza Corporation v. IMPAX: The Oxybutynin Case
On September 4, 2003, Alza Corporation (“Alza”) filed a lawsuit against IMPAX in the U.S. District Court for the Northern District of California alleging patent infringement of one patent related to IMPAX’s filing of an ANDA for a generic version of Ditropan XL (Oxybutynin Chloride) Tablets, 5 mg, 10 mg, and 15 mg. Alza seeks an injunction, a declaration of infringement, attorney’s fees and costs. On October 24, 2003, IMPAX filed its Answer to the Complaint, which included defenses to the infringement claim, and counterclaimed for patent non-infringement and invalidity. Discovery is on-going and trial is currently set for November 2005.
26
Back to Contents
On October 24, 2003, IMPAX filed a lawsuit against Alza in the U.S. District Court for the Northern District of California seeking a declaratory judgment that four Alza patents relating to IMPAX’s filing of an ANDA for a generic version of Ditropan XL (Oxybutynin Chloride) Tablets, 5 mg, 10 mg, and 15 mg are invalid and/or not infringed by the commercial manufacture, use, offer for sale, sale, or importation of the IMPAX product. On November 17, 2003, Alza moved to dismiss the Company’s complaint for lack of subject matter jurisdiction based on Alza’s argument that there is no case or controversy between the parties with respect to these four patents. On April 19, 2004, the Court denied Alza’s motion. On May 18, 2004, the Court ordered the entry of a stipulation of dismissal based on a covenant not to sue issued by Alza to the Company with respect to the four Alza patents in the case.
Shire Laboratories Inc. v IMPAX: The Adderall Case
On December 29, 2003, Shire Laboratories, Inc., a subsidiary of Shire Pharmaceuticals Group, PLC, filed a lawsuit against IMPAX in the U.S. District Court for the District of Delaware alleging patent infringement on U.S. Patent Nos. 6,322,819 and 6,605,300 related to filing of an ANDA to market a generic version of Adderall 30 mg capsules. IMPAX filed its answer on January 20, 2004, denying infringement and contesting the validity of both patents. All discovery is expected to be completed by March 2005. A tentative court date has been scheduled for October 11, 2005.
OTHER LITIGATION
State of California v. IMPAX
On August 7, 2003, IMPAX received an Accusation from the Department of Justice, Bureau of Narcotic Enforcement, State of California (“BNE”), alleging that IMPAX failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product in January 2003. IMPAX contested the allegations in the Accusation and entered into discussions with the State of California, Department of Justice, to bring resolution to this matter. IMPAX has implemented a number of remedial measures aimed at improving the security and accountability of precursor substances used by IMPAX and regulated by the California Department of Justice, Bureau of Narcotic Enforcement. In March 2004, following a theft of pseudoephedrine from IMPAX’s facilities, the BNE filed an Amended Accusation, again alleging that IMPAX failed to maintain adequate controls to safeguard precursors from theft or loss regarding our pseudoephedrine product. In May 2004, a Notice of Hearing was received from BNE, which set the hearing of this matter, should one be necessary, for October 18 and October 19, 2004. IMPAX is continuing its discussions with the State of California, Department of Justice, and hopes to resolve this matter without the need for a formal hearing.
Other than the legal proceedings described above, we are not aware of any other material pending or threatened legal actions, private or governmental, against us. However, as we file additional applications with the FDA that contain Paragraph IV certifications and develop new products, it is likely we will become involved in additional litigation related to those filings or products.
Insurance
As part of our patent litigation strategy, we had obtained two policies covering up to $7 million of patent infringement liability insurance from American International Specialty Line Company (“AISLIC”), an affiliate of AIG International. This litigation insurance covered us against the costs associated with patent infringement claims made against us relating to seven of the ANDAs we filed under Paragraph IV of the Hatch-Waxman Amendments. Both policies had reached their limits of liability. While Teva has agreed to pay 45% to 50% of the attorneys’ fees and costs (in excess of the $7 million expected to be covered by our insurance policies for six products) related to the twelve products covered by our strategic alliance agreement with them, we will be responsible for the remaining expenses and costs for these products, and all of the costs associated with patent litigation for our other products and our future products.
We do not believe that this type of litigation insurance will be available to us on acceptable terms for our other current or future ANDAs. In those cases, our policy is to record such expenses as incurred.
Product liability claims by customers constitute a risk to all pharmaceutical manufacturers. We currently carry $80 million of product liability insurance for our own manufactured products. This insurance may not be adequate to cover any product liability claims to which we may become subject.
ITEM 2. CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES
On May 17, 2004, we filed an amendment to our Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware, which amendment increased the number of our authorized shares of common stock from 75,000,000 to 90,000,000. Our board will generally be able to issue additional shares of common stock without the approval of our stockholders. These future issuances will dilute the ownership interests of our stockholders.
27
Back to Contents
1.250% Convertible Senior Subordinated Debentures
On April 5, 2004, the Company issued and sold $95.0 million in aggregate principal amount of its 1.250% convertible senior subordinated debentures due 2024. The debentures were sold by the Company to Citigroup Global Markets Inc., Wachovia Capital Markets, LLC and First Albany Capital Inc., as initial purchasers, in a private placement exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”). We have been advised by the initial purchasers that they have resold, and/or intend in the future to resell, the debentures to “qualified institutional buyers” (as defined in Rule 144A promulgated under the Securities Act) in transactions exempt from the registration requirements of the Securities Act in reliance on Rule 144A.
The issuance and sale of the debentures resulted in net proceeds to the Company of approximately $91,388,000. These proceeds are being used for general corporate purposes, including working capital requirements, manufacturing of our products and research and development.
The debentures bear interest at the rate of 1.250% per year. Interest on the debentures is payable on April 1 and October 1 of each year, beginning on October 1, 2004. The debentures are convertible by holders into shares of our common stock at a conversion price of $28.08 per share (which is subject to adjustment upon certain events, but represented a 30% premium over our stock price at the time the debentures were issued). The debentures are convertible by holders into shares of our common stock if (1) the price of our common stock reaches a specific threshold; (2) the trading price for the debentures falls below certain thresholds; (3) the debentures have been called for redemption; or (4) certain corporate transactions occur.
The debentures mature on April 1, 2024, unless earlier redeemed, repurchased or converted. Before April 5, 2007, we may redeem some or all of the debentures if the price of our common stock reaches a specific threshold, at a redemption price that includes an additional payment on the redeemed debentures equal to $230.77 per $1,000 principal amount of debentures, less the amount of any interest actually paid or accrued and unpaid on the debentures. On and after April 5, 2007, the Company may redeem some or all of the debentures at certain specified redemption prices.
The debentures are the Company’s unsecured obligations and are subordinated in right of payment to all of the Company’s existing and future senior indebtedness. On April 1, 2009, April 1, 2014, and April 1, 2019, and under certain circumstances, holders of the debentures will have the right to require us to repurchase all or any part of their debentures at a repurchase price equal to 100% of the principal amount of the debentures, plus accrued and unpaid interest and liquidated damages, if any, to, but excluding the repurchase date.
In connection with the offering of the debentures, we filed a Form S-3 registration statement with the SEC in June 2004. The registration statement has not yet been declared effective by the SEC. If the registration statement on Form S-3 is not declared effective by the SEC by October 4, 2004, then the interest rate payable on the debentures will be subject to increase.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
At the Company’s Annual Meeting of Stockholders held on May 17, 2004, the following actions were approved, by the votes indicated:
a) Ten directors were elected:
Leslie Z. Benet, Ph.D. | 43,846,077 | | For | 732,889 | | Withhold authority | |
Robert L. Burr | 43,735,232 | | For | 843,734 | | Withhold authority | |
Barry R. Edwards | 44,288,225 | | For | 290,741 | | Withhold authority | |
David J. Edwards | 43,791,680 | | For | 787,286 | | Withhold authority | |
Nigel Fleming, Ph.D. | 43,823,169 | | For | 755,797 | | Withhold authority | |
Charles Hsiao, Ph.D. | 44,186,440 | | For | 392,526 | | Withhold authority | |
Larry Hsu, Ph.D. | 44,287,092 | | For | 291,874 | | Withhold authority | |
Michael Markbreiter | 44,204,397 | | For | 374,569 | | Withhold authority | |
Oh Kim Sun | 44,405,446 | | For | 173,520 | | Withhold authority | |
Peter R. Terreri | 44,402,145 | | For | 176,821 | | Withhold authority | |
| |
b) | The proposed increase in the authorized shares of the Company’s common stock from 75,000,000 to 90,000,000, was approved as follows: |
43,025,827 | | | For | | | 1,510,097 | | | Against | | | 10,041 | | | Abstaining | |
28
Back to Contents
c) | The appointment of Deloitte & Touche LLP as the Company’s independent accountants for the fiscal year ending December 31, 2004 was ratified, as follows: |
| |
44,013,036 | | | For | | | 556,763 | | | Against | | | 9,167 | | | Abstaining | |
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) | | | Exhibits | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | • | | 3.18 | | | — | | | Certificate of Amendment of Restated Certificate of Incorporation of Impax Laboratories, Inc. dated as of May 17, 2004. | |
| | | | | | | | | | | | | | |
| | | | | • | | 10.65 | | | — | | | Second Amendment to Loan and Security Agreement between Wachovia Bank and Impax Laboratories, Inc. dated June 23, 2004. | |
| | | | | | | | | | | | | | |
| | | | | • | | 10.66 | | | — | | | Amendment to the Development, License and Supply Agreement between Wyeth Consumer Healthcare Division and Impax Laboratories, Inc. dated as of July 9, 2004. | |
| | | | | | | | | | | | | | |
| | | | | • | | 31.1 | | | — | | | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| | | | | | | | | | | | | | |
| | | | | • | | 31.2 | | | — | | | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| | | | | | | | | | | | | | |
| | | | | • | | 32.1 | | | — | | | Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
(b) | | | Reports | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | • | | On May 5, 2004, the Company furnished a report on Form 8-K (Items 9, 12) announcing earnings for the first quarter ended March 31, 2004. | |
| | | | | | | | |
| | | | | • | | On May 17, 2004, the Company filed a report on Form 8-K (Item 9) announcing that the FDA had granted final approval to the Company's ANDA for Carbidopa/Levodopa Extended Release Tablets. | |
| | | | | | | | |
| | | | | • | | On May 27, 2004, the Company filed a report on Form 8-K (Item 9) announcing that the FDA had granted final marketing approval to the Company's ANDA for its generic version of Zyban® 150 mg Controlled Release Tablets. | |
| | | | | | | | |
| | | | | • | | On May 28, 2004, the Company filed a report on Form 8-K (Item 9) announcing that the FDA had granted final marketing approval to the Company's ANDA for its generic version of Promatine 2.5 mg and 5 mg Tablets. | |
| | | | | | | | |
29
Back to Contents
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.
IMPAX LABORATORIES, INC. | |
| | |
| | |
| | |
By: | /s/ BARRY R. EDWARDS | August 9, 2004 |
|
|
|
| Chief Executive Officer | |
| (Principal Executive Officer) | |
| | |
| | |
| | |
By: | /s/ CORNEL C. SPIEGLER | August 9, 2004 |
|
|
|
| Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | |
30