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Washington, D.C. 20549
(Mark One) | ||
þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the fiscal year ended December 31, 2008 | ||
OR | ||
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from to |
Delaware | 65-0403311 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
30831 Huntwood Avenue, Hayward, CA (Address of principal executive offices) | 94544 (Zip Code) |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer þ | Smaller reporting company o |
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Item 1. | Business |
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• | 53 ANDAs approved by the FDA, which include generic versions of brand name pharmaceuticals such as Brethine®, Florinef®, Minocin®, Claritin-D®12-hour, Claritin-D®24-hour, Wellbutrin SR® and Prilosec®. | |
• | 24 applications pending at the FDA, including two tentatively approved (i.e., satisfying substantive FDA requirements but remaining subject to statutory pre-approval restrictions), that address approximately $13.5 billion in recent 12 month U.S. product sales. | |
• | 40 products in various stages of development for which applications have not yet been filed. |
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Product | Generic of | |
2004 OR EARLIER | ||
Pentoxifyline 400 mg Tablets(1) | Trental® | |
Orphenadrine 100 mg Tablets | Norflex® | |
Omeprazole 10 and 20 mg Capsules(2c) | Prilosec® | |
Minocycline 50, 75 and 100 mg Capsules | Minocin® | |
Sotalol 80, 120(1), 160(1) and 240 mg(1) Tablets | Betapace® | |
Terbutaline 2.5 and 5 mg Tablets | Brethine® | |
Fludrocortisone 0.1 mg Tablets | Florinef® | |
Rimantadine 100 mg Tablets | Flumadine® | |
Riluzole 50 mg Tablets(1) | Rilutek® | |
Pyridostigmine 60 mg Tablets | Mestinon® | |
Chloroquine 250 mg Tablets | N/A | |
Chloroquine 500 mg Tablets | Aralen® | |
Flavoxate 100 mg Tablets | Urispas® | |
Loratadine Orally Disintegrating Tablets, 10mg(1) | Claritin Reditab® | |
Fenofibrate 67, 134 and 200 mg Capsules | Lofibra® | |
Loratadine and Pseudoephedrine Sulfate 5/120 mg ER Tablets | Claritin-D 12-hr® | |
Methitest (Methyltestosterone) 10 and 25 mg(1) Tablets(2 separate ANDAs) | Android® | |
Bupropion Hydrochloride 100 and 150 mg ER Tablets (twice daily) | Wellbutrin SR® | |
Bupropion Hydrochloride 150 mg ER Tablets (twice daily) | Zyban® | |
Loratadine and Pseudoephedrine Sulfate 10/240 mg ER Tablets | Claritin-D® 24-Hour | |
Demeclocycline Hydrochloride 150 and 300 mg Tablets | Declomycin® | |
Carbidopa/Levodopa 25/100 & 50/200 mg ER Tablets | SinemetCR® | |
Midodrine Hydrochloride 2.5, 5 and 10 mg Tablets | ProAmatine | |
Metformin HCl 500 mg ER Tablets(1) | Glucophage XR® | |
Oxycodone Hydrochloride 80 mg ER Tablets(1) | OxyContin® | |
Bupropion Hydrochloride 200 mg ER Tablets (twice daily) | Wellbutrin SR® | |
2005 | ||
Dantrolene Sodium 25, 50 and 100 mg Capsules | Dantrium® | |
Anagrelide Hydrochloride 0.5 and 1.0 mg Capsules(1) | Agrylin® | |
Carprofen 25, 75 and 100 mg Caplets (a veterinary product) | Rimadyl® | |
Metformin HCI 750 mg ER Tablets(1) | Glucophage XR® | |
Oxycodone Hydrochloride 10, 20 and 40 mg Tablets(1) | OxyContin® | |
2006 | ||
Pilocarpine Hydrochloride 5 and 7.5 mg Tablets | Salagen® | |
Colestipol Hydrochloride 5 g Packet and 5 g Scoopful | Colestid® | |
Colestipol Hydrochloride 1 g Tablets | Colestid® |
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Product | Generic of | |
Bethanechol Chloride 5, 10, 25 and 50 mg Tablets(4 separate ANDAs) | Urecholine® | |
Oxybutynin Chloride 15 mg ER Tablets(2a) | Ditropan XL® | |
Bupropion Hydrochloride 300 mg ER Tablets(2b) (once daily) | Wellbutrin XL® | |
2007 | ||
Nadolol /Bendroflumethiazide 40/5 and 80/5 mg Tablets | Corzide® | |
Oxybutynin Chloride 5 and 10 mg ER Tablets(2a) | Ditropan XL® | |
Alprazolam 0.5, 1, 2 and 3 mg ER Tablets(1) | Xanax XR® | |
Gemfibrozil 600 mg Tablets(1) | Lopid® | |
Dipyridamole 25, 50, 75 mg Tablets USP | Persantine® | |
Baclofen 10 and 20 mg Tablets(2 separate ANDAs)(1) | N/A | |
2008 | ||
Primidone 50 and 250 mg Tablets | Mysoline® | |
Promethazine 12.5, 25 and 50 mg Tablets(2 separate ANDAs) | Phenergan® | |
Fenofibrate 54 and 160 mg Tablets | Lofibra® | |
Benzphetamine 50 mg Tablets(1) | Didrex® | |
Bupropion Hydrochloride 150 mg ER Tablets(2b) (once daily) | Wellbutrin XL® | |
2009 | ||
Omeprazole 40 mg Capsules(2c) | Prilosec® | |
Minocycline HCI 45, 90 and 135 mg ER Tablets(1) | Solodyn® |
(1) | Not currently marketed. | |
(2) | Multiple products filed under same ANDA, including (i) 2a: Oxybutynin Chloride products, (ii) 2b: Bupropion Hydrochloride products, and (iii) 2c: Omeprazole products. |
Product | Generic of | |
Cyclobenzaprine CD 15 and 30 mg Capsules | Amrix® | |
Doxycycline Hyclate DR 75 and 100 mg Tablets | Doryx® | |
Divalproex Sodium 250 and 500 mg ER Tablets | Depakote ER® | |
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60/120 mg ER Tablets | Allegra-D® | |
Methylphenidate HCI 18, 27, 36 and 54 mg ER Tablets | Concerta® | |
Oxymorphone HCI 5, 7.5, 10, 15, 20, 30 and 40 mg ER Tablets | Opana ER® | |
Single-Entity Amphetamine 5, 10, 15, 20, 25 and 30 mg ER Capsules | Adderall XR® | |
Tamsulosin 0.4 mg Capsules | Flomax® | |
Tolterodine Tartrate 2 and 4 mg ER Capsules | Detrol LA® | |
Tramadol HCI 100, 200 and 300 mg ER Tablets | Ultram ER® | |
Venlafaxine HCl 37.5, 75 and 150 mg ER Capsules | Effexor XR® | |
Duloxetine HCI 20, 30 and 60 mg DR Capsules | Cymbalta® |
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• | the ability to introduce generic versions of products promptly after a patent expires; | |
• | price; | |
• | product quality; | |
• | customer service (including maintenance of inventories for timely delivery); | |
• | the ability to identify and market niche products. |
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Years Ended December 31 | ||||||||||||||||||||||||
2008 | 2007 | 2006 | ||||||||||||||||||||||
($ in 000s) | ||||||||||||||||||||||||
Gross Revenue and% Gross Revenue | ||||||||||||||||||||||||
Teva Agreement | $ | 40,947 | 14 | % | $ | 42,480 | 13 | % | $ | 33,910 | 18 | % | ||||||||||||
Dava Agreement | $ | 40,831 | 14 | % | $ | 118,634 | 35 | % | $ | 2,899 | 2 | % | ||||||||||||
Sub-Total: Rx Partner | $ | 81,778 | 28 | % | $ | 161,114 | 48 | % | $ | 36,809 | 20 | % | ||||||||||||
OTC Partner | $ | 15,946 | 5 | % | $ | 11,866 | 4 | % | $ | 13,782 | 7 | % |
• | Prilosec® 10, 20 and 40 mg delayed released capsules | |
• | Wellbutrin SR® 100 and 150 mg extended release tablets | |
• | Zyban® 150 mg extended release tablets | |
• | Claritin-D®12-hour 120 mg12-hour extended release tablets | |
• | Claritin-D®24-hour 240 mg24-hour extended release tablets | |
• | Claritin Reditabs® 10 mg orally disintegrating tablets | |
• | Ditropan XL® 5, 10 and 15 mg extended release tablets | |
• | Glucophage XR® 500 mg extended release tablets | |
• | Allegra-D® 60/120 mg extended release tablets | |
• | Concerta® 18, 27, 36 and 54 mg extended release tablets | |
• | Wellbutrin XL® 150 and 300 mg extended release tablets |
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Upfront and | ||||||||||||||||
Aggregate | Milestone | |||||||||||||||
Upfront | Milestone | Payments | ||||||||||||||
OTC Partner | Initial Date | Payment | Payments | Received | ||||||||||||
(Unaudited and $ in 000s) | ||||||||||||||||
Schering-Plough | June 2002 | $ | 2,250 | $ | 2,250 | $ | 4,500 | |||||||||
Wyeth Consumer Healthcare | June 2002 | $ | 350 | $ | 4,050 | $ | 2,000 |
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Name | Age | Positions with Impax | ||||
Arthur A. Koch, Jr. | 55 | Senior Vice President, Finance, and Chief Financial Officer | ||||
Charles V. Hildenbrand | 57 | Senior Vice President, Operations | ||||
Christopher Mengler, R.Ph | 46 | President, Global Pharmaceuticals Division | ||||
Michael J. Nestor | 56 | President, Impax Pharmaceuticals Division |
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Item 1A. | Risk Factors |
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• | obtain FDA approval of our products; | |
• | successfully launch new products; | |
• | prevail in patent infringement litigation in which we are involved; | |
• | continue to generate or obtain sufficient capital on acceptable terms to fund our operations; and | |
• | comply with the many complex governmental regulations that deal with virtually every aspect of our business activities. |
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• | the availability of alternative products from our competitors; | |
• | the prices of our products relative to those of our competitors; | |
• | the timing of our market entry; | |
• | the ability to market our products effectively at the retail level; and | |
• | the acceptance of our products by government and private formularies. |
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• | proprietary processes or delivery systems; | |
• | larger research and development and marketing staffs; | |
• | larger production capabilities in a particular therapeutic area; | |
• | more experience in preclinical testing and human clinical trials; | |
• | more experience in obtaining required regulatory approvals, including FDA approval; | |
• | more products; or | |
• | more experience in developing new drugs and financial resources, particularly with regard to brand manufacturers. |
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• | delays in patient enrollment, and variability in the number and types of patients available for clinical trials; | |
• | regulators or institutional review boards may not allow us to commence or continue a clinical trial; | |
• | our inability, or the inability of our partners, to manufacture or obtain from third parties materials sufficient to complete our clinical trials; | |
• | delays or failure in reaching agreement on acceptable clinical trial contracts or clinical trial protocols with prospective clinical trial sites; | |
• | risks associated with trial design, which may result in a failure of the trial to show statistically significant results even if the product candidate is effective; | |
• | Difficulty in maintaining contact with patients after treatment commences, resulting in incomplete data; | |
• | poor effectiveness of product candidates during clinical trials; | |
• | safety issues, including adverse events associated with product candidates; | |
• | the failure of patients to complete clinical trials due to adverse side effects, dissatisfaction with the product candidate, or other reasons; | |
• | governmental or regulatory delays or changes in regulatory requirements, policy and guidelines; and | |
• | varying interpretation of data by the FDA or foreign regulatory agencies. |
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• | greater possibility for disruption due to transportation or communication problems; | |
• | the relative instability of some foreign governments and economies; | |
• | interim price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or fluctuations in currency exchange rates; and | |
• | uncertainty regarding recourse to a dependable legal system for the enforcement of contracts and other rights. |
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• | any of our future processes or products will be patentable; | |
• | our processes or products will not infringe upon the patents of third parties; or | |
• | we will have the resources to defend against charges of patent infringement by third parties or to protect our own rights against infringement by third parties. |
• | the timing of FDA approvals we receive; | |
• | the timing of process validation for particular generic drug products; |
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• | the timing of product launches | |
• | the introduction of new products by others that render our products obsolete or noncompetitive; | |
• | the ability to maintain selling prices and gross margins on our products; | |
• | the outcome of our patent infringement litigation; and | |
• | the addition or loss of customers. |
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• | our ability to maintain compliance with SEC reporting requirements; | |
• | our ability to relist our common stock on The NASDAQ Stock Market and maintain such listing; | |
• | investor perception of us; | |
• | analyst recommendations; | |
• | market conditions relating to specialty pharmaceutical companies; | |
• | announcements of new products by us or our competitors; | |
• | publicity regarding actual or potential developments relating to products under development by us or our competitors; | |
• | developments, disputes or litigation concerning patent or proprietary rights; | |
• | delays in the development or approval of our product candidates; | |
• | regulatory developments; | |
• | period to period fluctuations in our financial results and those of our competitors; | |
• | future sales of substantial amounts of common stock by stockholders; and | |
• | economic and other external factors. |
• | exercising voting, redemption, and conversion rights to the detriment of the holders of common stock; | |
• | receiving preferences over the holders of common stock regarding our assets in the event of our dissolution or liquidation; | |
• | delaying, deferring, or preventing a change in control of our company, even when holders of common stock may desire to effect such a transaction; | |
• | discouraging bids for our common stock at a premium over the market price of the common stock; and | |
• | otherwise adversely affecting the market price of the common stock. |
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Item 1B. | Unresolved Staff Comments |
Item 2. | Properties |
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Item 3. | Legal Proceedings |
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Item 4. | Submission of Matters to a Vote of Security Holders |
Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
Price Range | ||||||||
per Share | ||||||||
High | Low | |||||||
Year Ending December 31, 2008 | ||||||||
First Quarter | $ | 11.40 | $ | 6.50 | ||||
Second Quarter (through May 23, 2008) | $ | 9.55 | $ | 8.00 | ||||
Third Quarter | n/a | n/a | ||||||
Fourth Quarter | n/a | n/a | ||||||
Year Ended December 31, 2007 | ||||||||
First Quarter | $ | 10.76 | $ | 8.30 | ||||
Second Quarter | $ | 12.00 | $ | 4.55 | ||||
Third Quarter | $ | 12.40 | $ | 8.00 | ||||
Fourth Quarter | $ | 12.15 | $ | 9.45 |
• | any beneficial owners of common stock whose shares are held in the names of various dealers, clearing agencies, banks, brokers and other fiduciaries; and |
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• | broker-dealers or other participants who hold or clear shares directly or indirectly through the Depository Trust Company, or its nominee, Cede & Co. |
Number of Securities | ||||||||||||
Remaining Available for | ||||||||||||
Number of Securities to | Future Issuance Under | |||||||||||
be Issued Upon | Weighted Average | Equity Compensation | ||||||||||
Exercise of Outstanding | Exercise Price of | Plans (Excluding | ||||||||||
Options, Warrants and | Outstanding Options, | Securities Reflected in | ||||||||||
Rights | Warrants and Rights | Column (a)) | ||||||||||
Plan Category | (a) | (b) | (c) | |||||||||
Equity compensation plans approved by security holders | 6,027,029 | $ | 10.45 | 244,631 | ||||||||
Equity compensation plans not approved by security holders | 2,253,211 | (1) | $ | 10.72 | 1,641,200 | (2) | ||||||
Total: | 8,280,240 | $ | 10.53 | 1,885,831 |
(1) | Represents options issued pursuant to the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan in excess of the number of shares authorized for issuance under such plan. See Note 15 to our consolidated audited financial statements for information concerning our equity compensation plans. | |
(2) | Includes 435,793 shares of common stock available for future issuance under the Impax Laboratories, Inc. 2001 Non-Qualified Employee Stock Purchase Plan. |
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Item 6. | Selected Financial Data |
For the Years Ended December 31, | ||||||||||||||||||||
2008 | 2007 | 2006 | 2005 | 2004 | ||||||||||||||||
($ in 000s, except per share data) | ||||||||||||||||||||
Statements of Operations Data: | ||||||||||||||||||||
Total revenues | $ | 210,071 | $ | 273,753 | $ | 135,246 | $ | 112,400 | $ | 91,086 | ||||||||||
Research and development | 59,809 | 39,992 | 29,635 | 26,095 | 23,069 | |||||||||||||||
Total operating expenses | 114,179 | 89,590 | 74,245 | 59,588 | 76,301 | |||||||||||||||
Income (loss) from operations | 3,923 | 76,507 | (11,247 | ) | (5,623 | ) | (46,551 | ) | ||||||||||||
Net income (loss) | 18,700 | 125,925 | (12,044 | ) | (5,780 | ) | (48,825 | ) | ||||||||||||
Net income (loss) per share — basic | $ | 0.32 | $ | 2.14 | $ | (0.20 | ) | $ | (0.10 | ) | $ | (0.84 | ) | |||||||
Net income (loss) per share — diluted | $ | 0.31 | $ | 2.06 | $ | (0.20 | ) | $ | (0.10 | ) | $ | (0.84 | ) |
As of December 31, | ||||||||||||||||||||
2008 | 2007 | 2006 | 2005 | 2004 | ||||||||||||||||
($ in 000s) | ||||||||||||||||||||
Balance Sheet Data: | ||||||||||||||||||||
Cash, cash equivalents and short-term investments | $ | 119,985 | $ | 143,496 | $ | 29,834 | $ | 56,081 | $ | 79,039 | ||||||||||
Working capital | 126,639 | 110,107 | 81,919 | 55,796 | 76,151 | |||||||||||||||
Total assets | 514,582 | 516,459 | 343,888 | 260,285 | 259,077 | |||||||||||||||
Long-term debt | 5,990 | 20,510 | 89,603 | 80,285 | 102,047 | |||||||||||||||
Total liabilities | 355,184 | 382,292 | 347,864 | 251,399 | 244,831 | |||||||||||||||
Accumulated deficit | (41,590 | ) | (60,290 | ) | (186,215 | ) | (174,171 | ) | (168,390 | ) | ||||||||||
Total stockholders’ equity (deficit) | $ | 159,398 | $ | 134,167 | $ | (3,976 | ) | $ | 8,886 | $ | 14,246 |
Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
($ in 000s) | ||||||||||||
Chargeback reserve | ||||||||||||
Beginning balance | $ | 2,977 | $ | 4,401 | $ | 4,438 | ||||||
Provision recorded during the period | 50,144 | 33,972 | 26,664 | |||||||||
Credits issued during the period | (49,065 | ) | (35,396 | ) | (26,701 | ) | ||||||
Ending balance | $ | 4,056 | $ | 2,977 | $ | 4,401 | ||||||
Provision as a percent of Global product sales, gross | 28 | % | 23 | % | 21 | % |
December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
($ in 000s) | ||||||||||||
Rebate reserve | ||||||||||||
Beginning balance | $ | 3,603 | $ | 3,124 | $ | 5,391 | ||||||
Provision recorded during the period | 20,361 | 15,968 | 13,856 | |||||||||
Credits issued during the period | (19,164 | ) | (15,489 | ) | (16,123 | ) | ||||||
Ending balance | $ | 4,800 | $ | 3,603 | $ | 3,124 | ||||||
Provision as a percent of Global product sales, gross | 11 | % | 11 | % | 11 | % |
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December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
($ in 000s) | ||||||||||||
Accrued product returns | ||||||||||||
Beginning balance | $ | 14,261 | $ | 12,903 | $ | 10,625 | ||||||
Provision related to sales recorded in the period | 5,719 | 5,459 | 7,220 | |||||||||
Credits recorded in the period | (6,305 | ) | (4,101 | ) | (4,942 | ) | ||||||
Ending balance | $ | 13,675 | $ | 14,261 | $ | 12,903 | ||||||
Provision as a percent of Global product sales, gross | 3 | % | 4 | % | 6 | % |
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Payments Due by Period | ||||||||||||||||||||
Less Than | More Than | |||||||||||||||||||
($ in 000s) | Total | 1 Year | 1-3 Years | 3-5 Years | 5 Years | |||||||||||||||
Contractual Obligations(a) | ||||||||||||||||||||
Credit Facilities and Long- Term Debt(b) | $ | 20,647 | $ | 14,657 | $ | 3,873 | $ | 2,117 | $ | — | ||||||||||
Interest Expense Payable — Long-Term Debt | 1,286 | 686 | 520 | 80 | — | |||||||||||||||
Open Purchase Order Commitments | 11,796 | 11,796 | — | — | — | |||||||||||||||
Operating Lease(c) | 6,806 | 1,412 | 2,324 | 2,038 | 1,032 | |||||||||||||||
Construction Contracts(d) | 1,988 | 1,988 | — | — | — | |||||||||||||||
Total | $ | 42,523 | $ | 30,539 | $ | 6,717 | $ | 4,235 | $ | 1,032 |
(a) | Liabilities for incomes taxes under FIN 48 were excluded as the Company is not able to make a reasonably reliable estimate of the amount and period of related future payments. As of December 31, 2008, the Company had $7.5 million of gross unrecognized tax benefits under FIN 48. | |
(b) | Represents the principal portion of payments of debt obligations, including: (i) $12.75 million 3.5% Debentures callable on June 15, 2009, interest paid semi-annually, starting December 15, 2005; (ii) 6.0% note payable to Solvay in 24 quarterly principal and interest installment payments of $549,165 commencing March 2007 through December 2012; and (iii) Vendor financing agreement related to software licenses with interest at 3.10% in two monthly installments of $0 and thirty-four monthly principal and interest installments of $12,871 commencing December 2006 through November 2009. | |
(c) | We lease office, warehouse, and laboratory facilities under non-cancelable operating leases through June 2015. We also lease certain equipment under various non-cancelable operating leases with various expiration dates through 2013. | |
(d) | Construction contracts are related to our currently under construction facility in Taiwan, R.O.C., which is intended to be utilized for manufacturing, research and development, warehouse, and administrative space. The construction phase of this project is expected to be completed and equipment to be installed, validated, and approved by FDA in 2009, and product shipments to begin in early 2010. In conjunction with the construction of our Taiwan facility, we have entered into several contracts, amounting to an aggregate of approximately $16,617,000 and $853,000 as of December 31, 2008 and 2007, respectively. As of December 31, 2008 and 2007, we had remaining commitments under these contracts of approximately $1,988,000 and $422,000, respectively. |
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Item 7A. | Quantitative and Qualitative Disclosures about Market Risk |
Item 8. | Financial Statements and Supplementary Data |
Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
Item 9A(T). | Controls and Procedures |
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Item 9B. | Other Information |
Item 10. | Directors, Executive Officers and Corporate Governance |
Item 11. | Executive Compensation |
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
Item 13. | Certain Relationships and Related Transactions, and Director Independence |
Item 14. | Principal Accounting Fees and Services |
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Item 15. | Exhibits and Financial Statement Schedules |
Exhibit | ||||
No. | Description of Document | |||
3 | .1.1 | Restated Certificate of Incorporation, dated August 30, 2004.(1) | ||
3 | .1.2 | Certificate of Designation of Series A Junior Participating Preferred Stock, as filed with the Secretary of State of Delaware on January 21, 2009.(3) | ||
3 | .2 | By-Laws.(2) | ||
4 | .1 | Specimen of Common Stock Certificate.(2) | ||
4 | .2 | Form of Debenture (incorporated by reference to Exhibit A to the Indenture, dated as of June 27, 2005, between the Company and HSBC Bank USA, National Association, as Trustee, listed on Exhibit 4.3) | ||
4 | .3 | Indenture, dated as of June 27, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(2) | ||
4 | .4 | Supplemental Indenture, dated as of July 6, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(2) | ||
4 | .5 | Registration Rights Agreement, dated as of June 27, 2005, between the Company and the Initial Purchasers named therein.(2) | ||
4 | .6 | Promissory Note dated June 7, 2006, issued by the Company to Solvay Pharmaceuticals, Inc.(2) | ||
4 | .7 | Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(3) | ||
10 | .1 | Amended and Restated Loan and Security Agreement, dated as of December 15, 2005, between the Company and Wachovia Bank, National Association.(2) | ||
10 | .1.1 | First Amendment, dated October 14, 2008, to Amended and Restated Loan and Security Agreement, dated December 15, 2005, between the Company and Wachovia Bank, National Association.(4) | ||
10 | .1.2 | Second Amendment to Amended and Restated Loan and Security Agreement, effective as of December 31, 2008, by and among the Company and Wachovia Bank, National Association. | ||
10 | .2 | Purchase Agreement, dated June 26, 2005, between the Company and the Purchasers named therein.(2) | ||
10 | .3 | Impax Laboratories Inc. 1995 Stock Incentive Plan.*(2) | ||
10 | .3.1 | Amendment No. 1 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated July 1, 1998.* | ||
10 | .3.2 | Amendment No. 2 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated May 25, 1999.* | ||
10 | .4 | Impax Laboratories Inc. 1999 Equity Incentive Plan.* | ||
10 | .4.1 | Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.* | ||
10 | .5 | Impax Laboratories Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(2) | ||
10 | .6 | Impax Laboratories Inc. Amended and Restated 2002 Equity Incentive Plan.* | ||
10 | .6.1 | Form of Stock Option Grant under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.* | ||
10 | .6.2 | Form of Stock Bonus Agreement under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.* |
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Exhibit | ||||
No. | Description of Document | |||
10 | .7 | Impax Laboratories Inc. Executive Non-Qualified Deferred Compensation Plan, restated effective January 1, 2005.*(4) | ||
10 | .8 | Employment Agreement, dated as of December 14, 1999, between the Company and Charles Hsiao, Ph.D.*(4) | ||
10 | .9 | Employment Agreement, dated as of December 14, 1999, between the Company and Larry Hsu, Ph.D.*(4) | ||
10 | .10 | Offer of Employment Letter, dated August 12, 2004, between the Company and Charles V. Hildenbrand.* | ||
10 | .11 | Offer of Employment Letter, dated February 9, 2005, between the Company and Arthur A. Koch, Jr.* | ||
10 | .12.1 | Employment Agreement, dated as of September 1, 2006, between the Company and David S. Doll.*(2) | ||
10 | .12.2 | Separation Agreement and General Release, dated July 30, 2008, between the Company and David S. Doll.*(2) | ||
10 | .12.3 | Consulting Agreement, effective as of September 4, 2008, between the Company and David S. Doll.*(2) | ||
10 | .13 | Offer of Employment Letter, effective as of March 31, 2008, between the Company and Michael Nestor.* | ||
10 | .14 | Offer of Employment Letter, effective as of January 5, 2009, between the Company and Christopher Mengler.* | ||
10 | .15 | Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.1 | Letter Amendment, dated October 8, 2003, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.2 | Letter Agreement, dated March 24, 2005, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.3 | Letter Amendment, dated March 24, 2005 and effective January 1, 2005, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.4 | Amendment, dated January 24, 2006, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(6) | ||
10 | .15.5 | Amendment, dated February 9, 2007, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .16 | Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.**(5) | ||
10 | .16.1 | Amendment, dated as of July 9, 2004, to Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.(6) | ||
10 | .16.2 | Amendment, dated as of February 14, 2005, to Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.(6) | ||
10 | .17 | Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(6) | ||
10 | .17.1 | Amendment No. 3, effective as of July 23, 2004, to Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(5) | ||
10 | .17.2 | Amendment No. 4, effective as of December 15, 2006, to Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(5) | ||
10 | .18 | Supply and Distribution Agreement, dated as of November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(5) | ||
10 | .18.1 | Amendment No. 2, dated February 6, 2007, to Supply and Distribution Agreement, dated November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(6) | ||
10 | .19 | Patent License Agreement, dated as of March 30, 2007, by and among Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P. and the Company.(7) |
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Exhibit | ||||
No. | Description of Document | |||
10 | .20 | Supplemental License Agreement, dated as of March 30, 2007, by and among Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P. and the Company.(7) | ||
10 | .21 | Sublicense Agreement, effective as of March 30, 2007, between the Company and DAVA Pharmaceuticals, Inc.(7) | ||
10 | .22 | Promotional Services Agreement, dated as of January 19, 2006, between the Company and Shire US Inc.**(5) | ||
10 | .23 | Co-promotion Agreement, dated as of July 16, 2008, between the Company and Wyeth, acting through its Wyeth Pharmaceuticals Division.**(7) | ||
10 | .24 | Joint Development Agreement, dated as of November 26, 2008, between the Company and Medicis Pharmaceutical Corporation.**(5) | ||
10 | .25 | Special Cash Bonus Payments and Directors Fees.*(8) | ||
10 | .26 | Construction Work Agreement, dated as of February 18, 2008, by and between Impax Laboratories (Taiwan), Inc., a wholly-owned subsidiary of the Company, and E&C Engineering Corporation (English translation from the Taiwanese language). | ||
10 | .27 | Construction Agreement, dated as of March 11, 2008, by and between Impax Laboratories (Taiwan), Inc., a wholly-owned subsidiary of the Company, and Fu Tsu Construction (English translation from the Taiwanese language). | ||
11 | .1 | Statement re computation of per share earnings (incorporated by reference to Note 17 to the Notes to the Consolidated Financial Statements in this Annual Report onForm 10-K). | ||
21 | .1 | Subsidiaries of the registrant. | ||
31 | .1 | Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||
31 | .2 | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||
32 | .1 | Certifications of the Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* | Management contract, compensatory plan or arrangement. | |
** | Confidential treatment requested for certain portions of this exhibit pursuant toRule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
(1) | Incorporated by reference to Amendment No. 5 to the Company’s Registration Statement on Form 10 filed on December 23, 2008. | |
(2) | Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008. | |
(3) | Incorporated by reference to the Company’s Current Report onForm 8-K filed on January 22, 2009. | |
(4) | Incorporated by reference to Amendment No. 2 to the Company’s Registration Statement on Form 10 filed on December 2, 2008. | |
(5) | Incorporated by reference to Amendment No. 6 to the Company’s Registration Statement on Form 10 filed on January 14, 2009. | |
(6) | Incorporated by reference to Amendment No. 1 to the Company’s Registration Statement on Form 10 filed on November 12, 2008. | |
(7) | Incorporated by reference to Amendment No. 7 to the Company’s Registration Statement on Form 10 filed on January 21, 2009. | |
(8) | Incorporated by reference to the Company’s Current Report onForm 8-K filed on January 6, 2009. |
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F-2 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7 to F-58 | ||||
S-1 |
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/s/ Grant Thornton, LLP |
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December 31, | ||||||||
2008 | 2007 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 69,275 | $ | 37,462 | ||||
Short-term investments | 50,710 | 106,034 | ||||||
Accounts receivable, net | 43,306 | 51,503 | ||||||
Inventory, net | 32,305 | 27,568 | ||||||
Current portion of deferred product manufacturing costs-alliance agreements | 13,578 | 11,923 | ||||||
Current portion of deferred income taxes | 17,996 | 27,376 | ||||||
Prepaid expenses and other current assets | 9,298 | 8,592 | ||||||
Total current assets | 236,468 | 270,458 | ||||||
Property, plant and equipment, net | 95,629 | 81,223 | ||||||
Deferred product manufacturing costs-alliance agreements | 93,144 | 82,474 | ||||||
Deferred income taxes, net | 52,599 | 47,937 | ||||||
Other assets | 9,168 | 6,793 | ||||||
Goodwill | 27,574 | 27,574 | ||||||
Total assets | $ | 514,582 | $ | 516,459 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 14,657 | $ | 69,234 | ||||
Accounts payable | 12,797 | 16,898 | ||||||
Accrued expenses | 41,360 | 35,838 | ||||||
Current portion of deferred revenue-alliance agreements | 35,015 | 26,381 | ||||||
Current portion of accrued exclusivity period fee payments due | 6,000 | 12,000 | ||||||
Total current liabilities | 109,829 | 160,351 | ||||||
3.5% Debentures | — | 12,750 | ||||||
Long-term debt | 5,990 | 7,760 | ||||||
Fair value of common stock purchase warrants | — | 2,285 | ||||||
Deferred revenue-alliance agreements | 225,804 | 181,720 | ||||||
Accrued exclusivity period fee payments due | — | 6,000 | ||||||
Other liabilities | 13,561 | 11,426 | ||||||
Total liabilities | $ | 355,184 | $ | 382,292 | ||||
Commitments and contingencies (Notes 19 and 20) | ||||||||
Stockholders’ equity: | ||||||||
Preferred Stock, $0.01 par value, 2,000,000 shares authorized, 0 shares outstanding at December 31, 2008 and 2007 | $ | — | $ | — | ||||
Common stock, $0.01 par value, 90,000,000 shares authorized and 60,135,686 and 59,066,277 issued at December 31, 2008 and 2007, respectively | 602 | 591 | ||||||
Additional paid-in capital | 203,538 | 196,049 | ||||||
Treasury stock-acquired as a result of achievement of milestone under the Teva Agreement, 243,729 shares | (2,157 | ) | (2,157 | ) | ||||
Accumulated other comprehensive loss | (995 | ) | (26 | ) | ||||
Accumulated deficit | (41,590 | ) | (60,290 | ) | ||||
Total stockholders’ equity | $ | 159,398 | $ | 134,167 | ||||
Total liabilities and stockholders’ equity | $ | 514,582 | $ | 516,459 | ||||
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Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
Revenues: | ||||||||||||
Global product sales, net | $ | 98,602 | $ | 87,978 | $ | 78,201 | ||||||
Rx Partner | 81,778 | 161,114 | 36,809 | |||||||||
OTC Partner | 15,946 | 11,866 | 13,782 | |||||||||
Research Partner | 833 | — | — | |||||||||
Promotional Partner | 12,891 | 12,759 | 6,434 | |||||||||
Other | 21 | 36 | 20 | |||||||||
Total revenues | 210,071 | 273,753 | 135,246 | |||||||||
Cost of revenues | 91,969 | 107,656 | 72,248 | |||||||||
Gross profit | 118,102 | 166,097 | 62,998 | |||||||||
Operating expenses: | ||||||||||||
Research and development | 59,809 | 39,992 | 29,635 | |||||||||
Patent litigation | 6,472 | 10,025 | 9,693 | |||||||||
Litigation settlement | — | — | 2,556 | |||||||||
Selling, general and administrative | 47,898 | 39,573 | 32,361 | |||||||||
Total operating expenses | 114,179 | 89,590 | 74,245 | |||||||||
Income (loss) from operations | 3,923 | 76,507 | (11,247 | ) | ||||||||
Change in fair value of common stock purchase warrants | 1,234 | (110 | ) | 1,098 | ||||||||
Gain on repurchase of 3.5% Debentures | 1,319 | — | — | |||||||||
Other income (expense), net | 21,576 | 73 | (192 | ) | ||||||||
Interest income | 4,218 | 4,751 | 2,233 | |||||||||
Interest expense | (2,599 | ) | (4,113 | ) | (3,796 | ) | ||||||
Income (loss) before income taxes | 29,671 | 77,108 | (11,904 | ) | ||||||||
Provision (benefit) for income taxes | 10,971 | (48,817 | ) | 140 | ||||||||
Net income (loss) | $ | 18,700 | $ | 125,925 | $ | (12,044 | ) | |||||
Net income (loss) per share: | ||||||||||||
Basic | $ | 0.32 | $ | 2.14 | $ | (0.20 | ) | |||||
Diluted | $ | 0.31 | $ | 2.06 | $ | (0.20 | ) | |||||
Weighted average common shares outstanding: | ||||||||||||
Basic | 59,072,752 | 58,810,452 | 58,996,365 | |||||||||
Diluted | 60,782,721 | 61,217,470 | 58,996,365 | |||||||||
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CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
AND CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
FOR EACH OF THE THREE YEARS IN THE PERIOD ENDED DECEMBER 31, 2008
(dollars and shares in thousands)
Accumulated | ||||||||||||||||||||||||||||
Additional | Other | |||||||||||||||||||||||||||
Common Stock | Paid-In | Treasury | Accumulated | Comprehensive | ||||||||||||||||||||||||
Stockholders’ Equity (Deficit) | Shares | Par Value | Capital | Stock | Deficit | Loss | Total | |||||||||||||||||||||
Balance at December 31, 2005 | 58,977 | $ | 590 | $ | 182,467 | $ | — | $ | (174,171 | ) | $ | — | $ | 8,886 | ||||||||||||||
2006 | ||||||||||||||||||||||||||||
Exercise of common stock purchase warrants, stock options, and sale of common stock under ESPP | 52 | — | 659 | 659 | ||||||||||||||||||||||||
Share-based compensation expense | 683 | 683 | ||||||||||||||||||||||||||
Achievement of milestone under the Teva Agreement | (244 | ) | (2,157 | ) | (2,157 | ) | ||||||||||||||||||||||
Currency translation adjustments | (3 | ) | (3 | ) | ||||||||||||||||||||||||
Net loss | (12,044 | ) | (12,044 | ) | ||||||||||||||||||||||||
Balance at December 31, 2006 | 58,785 | $ | 590 | $ | 183,809 | $ | (2,157 | ) | $ | (186,215 | ) | $ | (3 | ) | $ | (3,976 | ) | |||||||||||
2007 | ||||||||||||||||||||||||||||
Exercise of common stock purchase warrants, stock options, and sale of common stock under ESPP | 37 | 1 | 250 | 251 | ||||||||||||||||||||||||
Share-based compensation expense | 1,513 | 1,513 | ||||||||||||||||||||||||||
Tax benefit related to exercise of employee stock options | 10,477 | 10,477 | ||||||||||||||||||||||||||
Currency translation adjustments | (23 | ) | (23 | ) | ||||||||||||||||||||||||
Net income | 125,925 | 125,925 | ||||||||||||||||||||||||||
Balance at December 31, 2007 | 58,822 | $ | 591 | $ | 196,049 | $ | (2,157 | ) | $ | (60,290 | ) | $ | (26 | ) | $ | 134,167 | ||||||||||||
2008 | ||||||||||||||||||||||||||||
Exercise of common stock purchase warrants and stock options, issuance of restricted stock and sale of common stock under ESPP | 994 | 10 | 1,029 | 1,039 | ||||||||||||||||||||||||
Share-based compensation expense | 5,817 | 5,817 | ||||||||||||||||||||||||||
Issuance of common stock | 76 | 1 | 643 | 644 | ||||||||||||||||||||||||
Currency translation adjustments | (969 | ) | (969 | ) | ||||||||||||||||||||||||
Net income | 18,700 | 18,700 | ||||||||||||||||||||||||||
Balance at December 31, 2008 | 59,892 | $ | 602 | $ | 203,538 | $ | (2,157 | ) | $ | (41,590 | ) | $ | (995 | ) | $ | 159,398 | ||||||||||||
Years Ended December 31, | ||||||||||||
Comprehensive Income (Loss) | 2008 | 2007 | 2006 | |||||||||
Net income (loss) | $ | 18,700 | $ | 125,925 | $ | (12,044 | ) | |||||
Currency translation adjustments | (969 | ) | (23 | ) | (3 | ) | ||||||
Comprehensive income (loss) | $ | 17,731 | $ | 125,902 | $ | (12,047 | ) | |||||
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Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
Cash flows from operating activities: | ||||||||||||
Net income (loss) | $ | 18,700 | $ | 125,925 | $ | (12,044 | ) | |||||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||||||
Depreciation and amortization | 9,895 | 8,612 | 7,307 | |||||||||
Bad debt expense | 568 | 550 | — | |||||||||
Tax benefit on reversal of valuation allowance on deferred tax asset | — | (81,485 | ) | — | ||||||||
Deferred income taxes, net | 4,718 | 17,483 | — | |||||||||
Tax benefit related to exercise of employee stock options | — | (10,477 | ) | — | ||||||||
Provision for uncertain tax positions | 1,397 | 6,118 | — | |||||||||
Gain, net on repurchase of 3.5% Debentures | (1,319 | ) | — | — | ||||||||
Deferred revenue — Rx Partners | 94,876 | 234,816 | 115,391 | |||||||||
Deferred product manufacturing costs — Rx Partners | (33,928 | ) | (64,681 | ) | (42,431 | ) | ||||||
Deferred revenue recognized — Rx Partners | (81,778 | ) | (161,114 | ) | (36,809 | ) | ||||||
Amortization deferred product manufacturing costs — Rx Partners | 22,713 | 46,363 | 14,006 | |||||||||
Deferred revenue — OTC Partners | 16,399 | 15,359 | 11,215 | |||||||||
Deferred product manufacturing costs — OTC Partners | (16,087 | ) | (13,014 | ) | (11,678 | ) | ||||||
Deferred revenue recognized — OTC Partners | (15,946 | ) | (11,866 | ) | (13,782 | ) | ||||||
Amortization deferred product manufacturing costs — OTC Partners | 14,977 | 9,900 | 12,421 | |||||||||
Deferred revenue — Research Partner | 40,000 | — | — | |||||||||
Deferred revenue recognized — Research Partner | (833 | ) | — | — | ||||||||
Payments on exclusivity period fee | (12,000 | ) | (18,200 | ) | (14,400 | ) | ||||||
Payments on accrued litigation settlements | (2,197 | ) | (2,573 | ) | (12,000 | ) | ||||||
Accrued litigation settlement expense | 3,500 | — | 2,556 | |||||||||
Share-based compensation expense | 5,817 | 1,513 | 683 | |||||||||
Fair value of shares issued under severance arrangement | 561 | — | — | |||||||||
Accretion of interest income on short-term investments | (2,867 | ) | (3,147 | ) | (1,004 | ) | ||||||
Change in fair value of common stock purchase warrants | (1,234 | ) | 110 | (1,098 | ) | |||||||
Changes in assets and liabilities: | ||||||||||||
Accounts receivable | 7,629 | 9,868 | (31,393 | ) | ||||||||
Inventory | (4,737 | ) | 6,543 | (846 | ) | |||||||
Prepaid expenses and other current assets | (4,184 | ) | (6,324 | ) | 1,960 | |||||||
Accounts payable and accrued expenses | (814 | ) | 7,546 | 4,372 | ||||||||
Other liabilities | 738 | 1,189 | 1,814 | |||||||||
Net cash provided by (used in) operating activities | $ | 64,564 | $ | 119,014 | $ | (5,760 | ) | |||||
Cash flows from investing activities: | ||||||||||||
Purchase of short-term investments | $ | (202,133 | ) | $ | (244,119 | ) | $ | (57,530 | ) | |||
Maturities of short-term investments | 260,324 | 164,667 | 35,302 | |||||||||
Purchases of property, plant and equipment | (25,863 | ) | (18,836 | ) | (21,475 | ) | ||||||
Net cash provided by (used in) investing activities | $ | 32,328 | $ | (98,288 | ) | $ | (43,703 | ) | ||||
Cash flows from financing activities: | ||||||||||||
Repayment of long-term debt | $ | (65,234 | ) | $ | (253 | ) | $ | (108 | ) | |||
Tax benefit related to exercise of employee stock options | — | 10,477 | — | |||||||||
Proceeds from stock option exercises and purchases under ESPP | 155 | 113 | 93 | |||||||||
Net cash (used in) provided by financing activities | $ | (65,079 | ) | $ | 10,337 | $ | (15 | ) | ||||
Net increase (decrease) in cash and cash equivalents | $ | 31,813 | $ | 31,063 | $ | (49,478 | ) | |||||
Cash and cash equivalents, beginning of the year | $ | 37,462 | $ | 6,399 | $ | 55,877 | ||||||
Cash and cash equivalents, end of year | $ | 69,275 | $ | 37,462 | $ | 6,399 | ||||||
Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(in $000s) | ||||||||||||
Cash paid for interest | $ | 2,970 | $ | 4,556 | $ | 3,409 | ||||||
Cash paid for income taxes | $ | 8,381 | $ | 14,106 | $ | 500 | ||||||
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1. | THE COMPANY |
2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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Percent of Total Accounts Receivable | 2008 | 2007 | 2006 | |||||||||
Customer #1 | 22.9 | % | 8.7 | % | 7.1 | % | ||||||
Customer #2 | 20.4 | % | 19.1 | % | 13.5 | % | ||||||
Customer #3 | 20.4 | % | 15.8 | % | 11.2 | % | ||||||
Customer #4 | 13.5 | % | 26.1 | % | 45.5 | % | ||||||
Customer #5 | 6.0 | % | — | — | ||||||||
Customer #6 | — | 8.4 | % | 5.0 | % | |||||||
Total-Five largest customers | 83.2 | % | 78.1 | % | 82.3 | % | ||||||
Percent of Gross Revenues | 2008 | 2007 | 2006 | |||||||||
Customer #1 | 18.0 | % | 13.2 | % | 17.3 | % | ||||||
Customer #2 | 14.0 | % | 12.7 | % | 18.3 | % | ||||||
Customer #3 | 13.9 | % | 35.5 | % | — | |||||||
Customer #4 | 11.6 | % | 10.3 | % | 17.9 | % | ||||||
Customer #5 | 10.9 | % | 5.5 | % | 8.4 | % | ||||||
Customer #6 | — | — | 5.5 | % | ||||||||
Total-Five largest customers | 68.4 | % | 77.2 | % | 67.4 | % | ||||||
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• | the delivered item has value to the customer on a stand alone basis; | |
• | there is objective and reliable evidence of the fair value of the undelivered item; and | |
• | if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the control of the vendor. |
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3. | RECENT ACCOUNTING PRONOUNCEMENTS |
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4. | INVESTMENTS |
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Gross | Gross | |||||||||||||||
Amortized | Unrecognized | Unrecognized | Fair | |||||||||||||
Cost | Gains | Losses | Value | |||||||||||||
(In $000’s) | ||||||||||||||||
December 31, 2008 | ||||||||||||||||
Commercial paper | $ | 6,194 | $ | — | $ | — | $ | 6,194 | ||||||||
Government agency obligations | 35,948 | 52 | (6 | ) | 35,994 | |||||||||||
Corporate bonds | 7,856 | — | (54 | ) | 7,802 | |||||||||||
Asset-backed securities | 481 | — | (31 | ) | 450 | |||||||||||
Certificates of deposit | 231 | — | — | 231 | ||||||||||||
Total short-term investments | $ | 50,710 | $ | 52 | $ | (91 | ) | $ | 50,671 | |||||||
Gross | Gross | |||||||||||||||
Amortized | Unrecognized | Unrecognized | Fair | |||||||||||||
Cost | Gains | Losses | Value | |||||||||||||
(In $000’s) | ||||||||||||||||
December 31, 2007 | ||||||||||||||||
Commercial paper | $ | 94,107 | $ | — | $ | — | $ | 94,107 | ||||||||
Government agency obligations | 7,000 | — | — | 7,000 | ||||||||||||
Corporate bonds | 3,202 | 5 | (8 | ) | 3,199 | |||||||||||
Asset-backed securities | 1,503 | — | (64 | ) | 1,439 | |||||||||||
Certificates of deposit | 222 | — | — | 222 | ||||||||||||
Total short-term investments | $ | 106,034 | $ | 5 | $ | (72 | ) | $ | 105,967 | |||||||
5. | ACCOUNTS RECEIVABLE |
December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Gross accounts receivable | $ | 54,591 | $ | 60,272 | ||||
Less: Rebate reserve | (4,800 | ) | (3,603 | ) | ||||
Less: Chargeback reserve | (4,056 | ) | (2,977 | ) | ||||
Less: Other deductions | (2,429 | ) | (2,189 | ) | ||||
Accounts receivable, net | $ | 43,306 | $ | 51,503 | ||||
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For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s) | ||||||||||||
Rebate reserve | ||||||||||||
Beginning balance | $ | 3,603 | $ | 3,124 | $ | 5,391 | ||||||
Provision recorded during the period | 20,361 | 15,968 | 13,856 | |||||||||
Credits issued during the period | (19,164 | ) | (15,489 | ) | (16,123 | ) | ||||||
Ending balance | $ | 4,800 | $ | 3,603 | $ | 3,124 | ||||||
For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s) | ||||||||||||
Chargeback reserve | ||||||||||||
Beginning balance | $ | 2,977 | $ | 4,401 | $ | 4,438 | ||||||
Provision recorded during the period | 50,144 | 33,972 | 26,664 | |||||||||
Credits issued during the period | (49,065 | ) | (35,396 | ) | (26,701 | ) | ||||||
Ending balance | $ | 4,056 | $ | 2,977 | $ | 4,401 | ||||||
6. | INVENTORY |
December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Raw materials | $ | 16,940 | $ | 15,005 | ||||
Work in process | 1,397 | 1,827 | ||||||
Finished goods | 16,504 | 11,373 | ||||||
Total inventory, net | $ | 34,841 | $ | 28,205 | ||||
Less: Non-current inventory, net | (2,536 | ) | (637 | ) | ||||
Inventory, net | $ | 32,305 | $ | 27,568 | ||||
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7. | PROPERTY, PLANT AND EQUIPMENT |
December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Land | $ | 2,270 | $ | 2,270 | ||||
Buildings and improvements | 55,310 | 51,287 | ||||||
Equipment | 49,983 | 44,001 | ||||||
Office furniture and equipment | 6,733 | 5,332 | ||||||
Construction-in-progress | 21,019 | 10,323 | ||||||
Property, plant and equipment, gross | 135,315 | 113,213 | ||||||
Less: Accumulated depreciation | (39,686 | ) | (31,990 | ) | ||||
Property, plant and equipment, net | $ | 95,629 | $ | 81,223 | ||||
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8. | ACCRUED EXPENSES |
December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Payroll related expenses | $ | 15,147 | $ | 9,983 | ||||
Product returns | 13,675 | 14,261 | ||||||
Shelf stock price protection | 572 | 384 | ||||||
Medicaid rebates | 584 | 566 | ||||||
Royalty expense | 259 | 551 | ||||||
Physician detailing sales force fees | 2,279 | 2,096 | ||||||
Legal and professional fees | 2,087 | 3,382 | ||||||
Litigation settlements | 4,526 | 1,555 | ||||||
Other | 2,231 | 3,060 | ||||||
Total accrued expenses | $ | 41,360 | $ | 35,838 | ||||
December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s) | ||||||||||||
Beginning balance | $ | 14,261 | $ | 12,903 | $ | 10,625 | ||||||
Provision related to sales recorded in the period | 5,719 | 5,459 | 7,220 | |||||||||
Credits recorded in the period | (6,305 | ) | (4,101 | ) | (4,942 | ) | ||||||
Ending balance | $ | 13,675 | $ | 14,261 | $ | 12,903 | ||||||
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9. | FAIR VALUE OF COMMON STOCK PURCHASE WARRANTS |
Common | Common | |||||||||||
Stock | Stock | Total | ||||||||||
Purchase | Purchase | Reported | ||||||||||
Warrants | Warrants | Liability | ||||||||||
Outstanding | Value | Value | ||||||||||
Ending balance December 31, 2005 | 741,503 | $ | 5.36 | $ | 3,977,000 | |||||||
Warrants exercised in 2006 | (100,000 | ) | ||||||||||
Ending balance December 31, 2006 | 641,503 | $ | 3.60 | $ | 2,313,000 | |||||||
Warrants exercised in 2007 | (36,616 | ) | ||||||||||
Ending balance December 31, 2007 | 604,887 | $ | 3.78 | $ | 2,285,000 | |||||||
Warrants exercised in 2008 | (604,887 | ) | ||||||||||
Ending balance December 31, 2008 | — | $ | — | $ | — | |||||||
For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
Volatility (range) | 43.0 - 49.0 | % | 24.2 - 46.4 | % | 48.7 - 57.6 | % | ||||||
Risk-free interest rate (range) | 1.25 - 1.50 | % | 3.4 - 4.9 | % | 4.7 - 5.2 | % | ||||||
Dividend yield | 0 | % | 0 | % | 0 | % |
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10. | INCOME TAXES |
For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s) | ||||||||||||
Current: | ||||||||||||
Federal taxes | $ | 6,315 | $ | 8,383 | $ | 320 | ||||||
State taxes | (62 | ) | 6,802 | 190 | ||||||||
Total current tax expense | 6,253 | 15,185 | 510 | |||||||||
Deferred: | ||||||||||||
Federal taxes | $ | 3,478 | $ | 17,830 | $ | (4,971 | ) | |||||
Federal taxes-change in valuation allowance | — | (66,783 | ) | 4,651 | ||||||||
State taxes | 1,240 | (347 | ) | (2,391 | ) | |||||||
State taxes-change in valuation allowance | — | (14,702 | ) | 2,341 | ||||||||
Foreign taxes | — | — | — | |||||||||
Total deferred tax expense (benefit) | 4,718 | (64,002 | ) | (370 | ) | |||||||
Provision for (benefit from) income taxes | $ | 10,971 | $ | (48,817 | ) | $ | 140 | |||||
For the Years Ended December 31, | ||||||||||||||||||||||||
2008 | 2007 | 2006 | ||||||||||||||||||||||
(In $000’s) | ||||||||||||||||||||||||
Income (loss) before income taxes | $ | 29,671 | $ | 77,108 | $ | (11,904 | ) | |||||||||||||||||
Tax provision (benefit) at federal statutory rate | 10,385 | 35.0 | % | 26,988 | 35.0 | % | (4,047 | ) | (34.0 | )% | ||||||||||||||
Increase (decrease) in tax rate resulting from: | ||||||||||||||||||||||||
State and local taxes, net of federal benefit | 130 | 0.5 | % | 2,886 | 3.8 | % | (1,699 | ) | (14.3 | )% | ||||||||||||||
Increase in federal statutory tax rate on deferred tax accounts | — | — | (1,993 | ) | (2.6 | )% | — | — | ||||||||||||||||
Research and development credits | (2,228 | ) | (7.5 | )% | (1,306 | ) | (1.7 | )% | (996 | ) | (8.3 | )% | ||||||||||||
Share-based compensation | 1,438 | 4.9 | % | 528 | 0.7 | % | 232 | 2.0 | % | |||||||||||||||
Domestic manufacturing deduction | (531 | ) | (1.8 | )% | (676 | ) | (0.9 | )% | — | — | ||||||||||||||
Change in warrant fair value | (432 | ) | (1.5 | )% | 38 | 0.1 | % | (373 | ) | (3.1 | )% | |||||||||||||
Provision for uncertain tax positions | 1,050 | 3.5 | % | 6,118 | 7.9 | % | — | — | ||||||||||||||||
Other, net | 1,159 | 3.9 | % | 85 | 0.1 | % | 31 | 0.2 | % | |||||||||||||||
Change in valuation allowance | — | — | (81,485 | ) | (105.7 | )% | 6,992 | 58.7 | % | |||||||||||||||
Provision for (benefit from) income taxes | $ | 10,971 | 37.0 | % | $ | (48,817 | ) | (63.3 | )% | $ | 140 | 1.2 | % | |||||||||||
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December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 830 | $ | 1,024 | ||||
Research and development credits | 3,009 | 6,118 | ||||||
Inventory reserves | 2,490 | 1,249 | ||||||
Accrued expenses | 11,711 | 10,230 | ||||||
Deferred revenues | 87,789 | 81,654 | ||||||
Accrued exclusivity period fee payments | 3,073 | 7,145 | ||||||
Litigation settlements | 2,376 | 3,345 | ||||||
Depreciation and amortization | 371 | — | ||||||
Other | 4,838 | 3,752 | ||||||
Gross deferred tax assets | $ | 116,487 | $ | 114,517 | ||||
Deferred tax liabilities: | ||||||||
Tax depreciation and amortization in excess of book amounts | $ | 2,205 | $ | 1,508 | ||||
Deferred manufacturing costs | 42,267 | 37,468 | ||||||
Deferred revenues | 854 | — | ||||||
Other | 566 | 228 | ||||||
Gross deferred tax liabilities | $ | 45,892 | $ | 39,204 | ||||
Deferred tax assets, net | $ | 70,595 | $ | 75,313 | ||||
December 31, | ||||||||
2008 | 2007 | |||||||
(In $000’s) | ||||||||
Current deferred tax assets | $ | 23,940 | $ | 32,336 | ||||
Current deferred tax liabilities | (5,944 | ) | (4,960 | ) | ||||
Current deferred tax assets, net | 17,996 | 27,376 | ||||||
Non-current deferred tax assets | 92,547 | 82,181 | ||||||
Non-current deferred tax liabilities | (39,948 | ) | (34,244 | ) | ||||
Non-current deferred tax assets, net | 52,599 | 47,937 | ||||||
Deferred tax assets, net of valuation allowance | $ | 70,595 | $ | 75,313 | ||||
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Year | Amount | |||
(In $000’s) | ||||
2020 | $ | 2,075 | ||
2021 | 4,968 | |||
2022 | 1,955 | |||
2023 | 3,775 | |||
Total | $ | 12,773 | ||
(In $000’s) | ||||
Balance at January 1, 2008 | $ | 6,118 | ||
Increase/(decrease) based on prior year tax positions | — | |||
Increase/(decrease) based on current year tax positions | 1,397 | |||
Balance at December 31, 2008 | $ | 7,515 | ||
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11. | REVOLVING LINE OF CREDIT |
12. | LONG-TERM DEBT |
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December 31, | ||||||||
2008 | 2007 | |||||||
(In $000s) | ||||||||
3.5% Debentures(1) | $ | 12,750 | $ | 75,000 | ||||
8.17% Term loan — Cathay Bank(2) | — | 2,215 | ||||||
7.5% Term loan — Cathay Bank(3) | — | 2,957 | ||||||
Subordinated promissory note(4) | 7,760 | 9,428 | ||||||
Vendor financing agreement(5) | 137 | 144 | ||||||
Total Debt | $ | 20,647 | $ | 89,744 | ||||
Less: Current portion of long-term debt | (14,657 | ) | (69,234 | ) | ||||
Long-term debt | $ | 5,990 | $ | 20,510 | ||||
(1) | In August and September 2008, the Company repurchased at a discount an aggregate of $62,250,000 face value principal amount of its 3.5% Debentures at the request of the holders. The remaining $12,750,000 principal amount matures on June 15, 2012, but is subject to repurchase by the Company at 100% of the outstanding principal amount on June 15, 2009, at the option of the holders. | |
(2) | Term loan payable at 8.17% to Cathay Bank in 83 monthly installments of $19,540 commencing June 28, 2001 through May 27, 2008 with a balance due on June 28, 2008. The 8.17% Cathay Bank loan was collateralized by land, building and building improvements in the Company’s 35,000 square foot headquarters and research facility in Hayward, California. This loan was paid in full without penalty in May 2008. | |
(3) | Term loan payable at 7.5% to Cathay Bank in 83 monthly installments of $24,629 commencing November 14, 2001 through October 13, 2008 with a balance of $2,917,598 due on November 14, 2008. The 7.5% Cathay Bank loan was collateralized by land, building and building improvements in the Company’s 50,000 square foot manufacturing facility in Hayward, California. This loan was paid in full without penalty in May 2008. | |
(4) | Subordinated promissory note in the amount of $11,000,000 related to the June 2006 settlement of litigation brought by Solvay Pharmaceuticals, Inc. (“Solvay”). In the settlement, the Company agreed to pay $23,000,000 to Solvay, with such amount recorded as litigation settlement expense in the Company’s 2004 financial statements. The settlement included a $12,000,000 cash payment upon signing of the settlement agreement with the remaining $11,000,000 to be paid under the terms of the subordinated promissory note between the Company and Solvay. The subordinated promissory note interest rate is 6.0% per annum, and requires the Company to pay 24 quarterly installments of $549,165, commencing in March 2007 through December 2012. Additionally, the subordinated promissory note becomes immediately due and payable upon the occurrence of a default in any payment due, a change in control of the Company, voluntary or involuntary bankruptcy proceeding by or against the Company, and working capital less than 150% of the remaining unpaid balance of the subordinated promissory note. At December 31, 2008, none of these events has occurred to date. | |
(5) | Vendor financing agreement related to software licenses, with interest at 3.1% annum, and two monthly installments of $0 and thirty-four monthly installments of $12,871, commencing December 2006 through November 2009. |
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(In $000’s) | ||||
2009 | $ | 14,657 | ||
2010 | 1,879 | |||
2011 | 1,994 | |||
2012 | 2,117 | |||
2013 | — | |||
Thereafter | — | |||
Total | $ | 20,647 | ||
13. | ALLIANCE AGREEMENTS |
• | Contingent Sale of Market Exclusivity— The Teva Agreement obligated the Company to deliver and Teva to purchase the exclusive marketing rights for four of the 12 covered products for $22,000,000 to the extent the Company achieved specified product development milestones relating to four products. Portions of this $22,000,000 purchase price were assigned to milestones based on their negotiated values at the inception of the Teva Agreement. If some, but not all of the milestones were achieved, then exclusive marketing rights would transfer only for those products for which the related milestones were met. To the extent the |
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milestones were not achieved by January 15, 2004 and Teva had not exercised the contingent option to purchase market exclusivity described below, the related exclusive marketing rights would not be transferred to Teva, the Company would be required to repay the corresponding portions of the $22,000,000 advance deposit and Teva would retain non-exclusive marketing rights with respect to the related products. The milestones and related portions to be repaid were: $2,000,000 if tentative FDA approval for one specified product was not obtained by June 15, 2002; $5,000,000 if the same product was not launched by February 15, 2003; $5,000,000 and $4,000,000, respectively, if two additional products were not launched by December 15, 2003; $1,000,000 if tentative FDA approval of a fourth product was not received by January 15, 2003; and $5,000,000 if the same product was not launched by December 15, 2003. |
• | Contingent Option to Purchase Market Exclusivity— The Company also granted Teva an option to purchase the exclusive marketing rights to the four specified products to the extent the product development milestones were not met. Teva could exercise this right by forgiving repayment of half of the foregoing portions of the $22,000,000 advance deposit payable as assigned in the Teva Agreement to the specified product. | |
• | The Company’s Share Settlement Option— To the extent the Company failed to achieve the milestones and Teva failed to exercise its option to purchase market exclusivity for the four specified products and the Company was thus required to repay the advance deposit, the Company had the option to settle, or repay, the applicable portion of the advance deposit either in cash or with shares of its common stock valued at the average closing price of the stock during the ten trading days ending two days prior to the date of Teva’s receipt of the shares (“Designated Share Price”). | |
• | Interest Forgiveness /FDA Approval Provision— Under the terms of the Teva Agreement, when the Company received FDA approval for any three of the 12 covered products, the entire amount of interest payable under the advance deposit would be forgiven. The nominal amount of the accrued interest expected to be incurred over the life of the advance deposit was estimated not to exceed approximately $4,400,000. |
• | Contingent Stock Repurchase Option. The Teva Agreement divided eleven of the products into three categories, referred to as “product tiers.” The Tier 1 products were those pending FDA approval when the Teva Agreement was entered into, whereas Tier 2 and Tier 3 products were those for which applications to the FDA had not as yet been filed at the inception of the Teva Agreement. The Teva Agreement gave the Company the option to repurchase from Teva 243,729 shares of its common stock (one-sixth of the shares initially sold to Teva) for $1.00 contingent upon Teva achieving a commercial sale of either a Tier 2 or Tier 3 product. |
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• | Teva’s reimbursement of manufacturing costs; | |
• | The Company’s profit share associated with Teva’s sales of products to its customers; | |
• | The sale of market exclusivity for certain products; | |
• | The estimated fair value received upon the Company’s exercise of the contingent stock repurchase option upon achieving the commercial sale of a Tier 2 or Tier 3 product; | |
• | Teva’s reimbursement of regulatory and litigation costs; and | |
• | The value received as a result of the forgiveness of interest on the advance deposit upon receipt of the third FDA approval to market a product. |
• | Teva’s reimbursement of manufacturing costs— at the time the Company delivers the product to Teva; | |
• | The Company’s pro rata profit share— at the time Teva reports the Company’s respective pro rata profit share to the Company; | |
• | The sale of market exclusivity— at the time market exclusivity was delivered by Teva’s exercise of its contingent option to purchase market exclusivity; | |
• | The milestone associated with the first commercial sale of a Tier 2 or Tier 3 product and concurrent exercise of the contingent stock repurchase option — at the time the right to exercise the option accrued; | |
• | Cost sharing payments— at the time the related costs are incurred (except for the $300,000 cost reimbursement payable upon inception of the Teva Agreement, recognition of which began at such inception); and | |
• | Forgiveness of interest— at the time the Company received its third FDA approval to market a product covered by the agreement. |
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Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred revenue | ||||||||||||||||
Beginning balance | $ | 181,149 | $ | 136,157 | $ | 78,014 | $ | — | ||||||||
Additions: | ||||||||||||||||
Cost sharing | 700 | 732 | 861 | 3,660 | ||||||||||||
Product related deferrals | 59,706 | 133,873 | 92,502 | 89,990 | ||||||||||||
Subtotal | 60,406 | 134,605 | 93,363 | 93,650 | ||||||||||||
Exclusivity charges | — | (47,133 | ) | (3,467 | ) | — | ||||||||||
Forgiveness of advance deposit | — | — | — | 6,000 | ||||||||||||
Forgiveness of interest | — | — | — | 4,370 | ||||||||||||
Stock repurchase | — | — | 2,157 | — | ||||||||||||
Total additions | $ | 60,406 | $ | 87,472 | $ | 92,053 | $ | 104,020 | ||||||||
Less: amounts recognized: | ||||||||||||||||
Forgiveness of advance deposit | $ | (333 | ) | $ | (333 | ) | $ | (333 | ) | $ | (1,500 | ) | ||||
Forgiveness of interest | (243 | ) | (243 | ) | (243 | ) | (1,094 | ) | ||||||||
Stock repurchase | (120 | ) | (120 | ) | (659 | ) | — | |||||||||
Cost sharing | (583 | ) | (516 | ) | (466 | ) | (916 | ) | ||||||||
Product related revenue | (39,668 | ) | (41,268 | ) | (32,209 | ) | (22,496 | ) | ||||||||
Total amount recognized | (40,947 | ) | (42,480 | ) | (33,910 | ) | (26,006 | ) | ||||||||
Total deferred revenue | $ | 200,608 | $ | 181,149 | $ | 136,157 | $ | 78,014 | ||||||||
Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred product manufacturing costs | ||||||||||||||||
Beginning balance | $ | 75,296 | $ | 49,728 | $ | 27,059 | $ | — | ||||||||
Additions | 33,621 | 46,246 | 35,530 | 36,079 | ||||||||||||
Less amounts amortized | (20,556 | ) | (20,678 | ) | (12,861 | ) | (9,020 | ) | ||||||||
Total deferred product manufacturing costs | $ | 88,361 | $ | 75,296 | $ | 49,728 | $ | 27,059 | ||||||||
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Deferred | ||||||||
Deferred | Product | |||||||
Revenue | Manufacturing Costs | |||||||
Recognition | Amortization | |||||||
(In $000s) | ||||||||
2009 | $ | 19,112 | $ | 8,415 | ||||
2010 | 19,112 | 8,415 | ||||||
2011 | 19,112 | 8,415 | ||||||
2012 | 19,112 | 8,415 | ||||||
2013 | 19,112 | 8,415 | ||||||
Thereafter | 105,048 | 46,286 | ||||||
Totals | $ | 200,608 | $ | 88,361 | ||||
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Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred revenue | ||||||||||||||||
Beginning balance | $ | 20,591 | $ | 17,098 | $ | 19,665 | $ | — | ||||||||
Additions: | ||||||||||||||||
Upfront fees and milestone payments | — | 84 | 42 | 8,310 | ||||||||||||
Cost sharing and other | — | 424 | 158 | 1,060 | ||||||||||||
Product related deferrals | 16,399 | 14,851 | 11,015 | 39,601 | ||||||||||||
Total additions | $ | 16,399 | $ | 15,359 | $ | 11,215 | $ | 48,971 | ||||||||
Less: amounts recognized: | ||||||||||||||||
Upfront fees and milestone payments | (297 | ) | (315 | ) | (786 | ) | (6,071 | ) | ||||||||
Cost sharing and other | (112 | ) | (312 | ) | (221 | ) | (793 | ) | ||||||||
Product related revenue | (15,537 | ) | (11,239 | ) | (12,775 | ) | (22,442 | ) | ||||||||
Total amount recognized | (15,946 | ) | (11,866 | ) | (13,782 | ) | (29,306 | ) | ||||||||
Total deferred revenue | $ | 21,044 | $ | 20,591 | $ | 17,098 | $ | 19,665 | ||||||||
Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred product manufacturing costs | ||||||||||||||||
Beginning balance | $ | 17,251 | $ | 14,137 | $ | 14,880 | $ | — | ||||||||
Additions: | ||||||||||||||||
Product related deferrals | 16,037 | 12,172 | 11,727 | 29,981 | ||||||||||||
Cost sharing and other | 50 | 842 | (49 | ) | 5,181 | |||||||||||
Total additions | $ | 16,087 | $ | 13,014 | $ | 11,678 | $ | 35,162 | ||||||||
Less: amount amortized: | ||||||||||||||||
Product related cost | (14,634 | ) | (9,201 | ) | (12,024 | ) | (17,260 | ) | ||||||||
Cost sharing and other | (343 | ) | (699 | ) | (397 | ) | (3,022 | ) | ||||||||
Total amount amortized | (14,977 | ) | (9,900 | ) | (12,421 | ) | (20,282 | ) | ||||||||
Total deferred product manufacturing costs | $ | 18,361 | $ | 17,251 | $ | 14,137 | $ | 14,880 | ||||||||
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Deferred | ||||||||
Deferred | Product | |||||||
Revenue | Manufacturing Costs | |||||||
Recognition | Amortization | |||||||
(In $000s) | ||||||||
2009 | $ | 5,903 | $ | 5,163 | ||||
2010 | 5,903 | 5,163 | ||||||
2011 | 1,949 | 1,703 | ||||||
2012 | 1,158 | 1,011 | ||||||
2013 | 1,158 | 1,011 | ||||||
Thereafter | 4,973 | 4,310 | ||||||
Total | $ | 21,044 | $ | 18,361 | ||||
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Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred revenue | ||||||||||||||||
Beginning balance | $ | 6,361 | $ | 24,784 | $ | 5,655 | $ | — | ||||||||
Additions: | ||||||||||||||||
Upfront fees and milestone payments | — | — | 9,000 | 1,000 | ||||||||||||
Product related deferrals | 34,470 | 100,211 | 13,028 | 4,738 | ||||||||||||
Total additions | 34,470 | 100,211 | 22,028 | 5,738 | ||||||||||||
Less: amounts recognized: | ||||||||||||||||
Upfront fees and milestone payments | (858 | ) | (7,975 | ) | (1,150 | ) | (17 | ) | ||||||||
Product related revenue | (39,973 | ) | (110,659 | ) | (1,749 | ) | (66 | ) | ||||||||
Total amount recognized | (40,831 | ) | (118,634 | ) | (2,899 | ) | (83 | ) | ||||||||
Total deferred revenue | $ | — | $ | 6,361 | $ | 24,784 | $ | 5,655 | ||||||||
Inception | ||||||||||||||||
Through | ||||||||||||||||
For the Years Ended December 31, | Dec 31, | |||||||||||||||
2008 | 2007 | 2006 | 2005 | |||||||||||||
(In $000’s) | ||||||||||||||||
Deferred product manufacturing costs | ||||||||||||||||
Beginning balance | $ | 1,850 | $ | 9,100 | $ | 3,344 | $ | — | ||||||||
Additions | 307 | 18,435 | 6,901 | 3,401 | ||||||||||||
Less: amount recognized | (2,157 | ) | (25,685 | ) | (1,145 | ) | (57 | ) | ||||||||
Total deferred product manufacturing costs | $ | — | $ | 1,850 | $ | 9,100 | $ | 3,344 | ||||||||
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Year Ended | ||||
December 31, | ||||
2008 | ||||
(In $000’s) | ||||
Deferred revenue | ||||
Beginning balance | $ | — | ||
Additions: | ||||
Up-front fees and milestone payments | 40,000 | |||
Product related deferrals | — | |||
Total additions | 40,000 | |||
Less: amounts recognized: | ||||
Up-front fees and milestone payments | (833 | ) | ||
Product related revenue | — | |||
Total amount recognized | (833 | ) | ||
Total deferred revenue | $ | 39,167 | ||
Deferred | ||||
Revenue | ||||
Recognition | ||||
(In $000s) | ||||
2009 | $ | 10,000 | ||
2010 | 10,000 | |||
2011 | 10,000 | |||
2012 | 9,167 | |||
2013 | — | |||
Thereafter | — | |||
Total | $ | 39,167 | ||
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14. | EMPLOYEE BENEFIT PLANS |
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15. | SHARE-BASED COMPENSATION: |
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Weighted | ||||||||
Average | ||||||||
Exercise | ||||||||
Number of Shares | Price | |||||||
Stock Options | Under Option | per Share | ||||||
Outstanding at December 31, 2005 | 7,152,301 | $ | 10.06 | |||||
Options granted | 291,000 | $ | 6.85 | |||||
Options exercised | (8,613 | ) | $ | 4.21 | ||||
Options forfeited | (296,517 | ) | $ | 21.38 | ||||
Outstanding at December 31, 2006 | 7,138,171 | $ | 9.46 | |||||
Options granted | 1,991,678 | $ | 11.34 | |||||
Options exercised | (20,719 | ) | $ | 2.28 | ||||
Options forfeited | (61,369 | ) | $ | 8.38 | ||||
Outstanding at December 31, 2007 | 9,047,761 | $ | 9.90 | |||||
Options granted | 539,850 | $ | 8.80 | |||||
Options exercised | (956,824 | ) | $ | 4.18 | ||||
Options forfeited | (350,547 | ) | $ | 9.07 | ||||
Outstanding at December 31, 2008 | 8,280,240 | $ | 10.53 | |||||
Vested and expected to vest at December 31, 2008 | 8,155,317 | $ | 10.58 | |||||
Options exercisable at December 31, 2008 | 6,396,840 | $ | 10.58 | |||||
Non-Vested | Weighted | |||||||
Restricted | Average | |||||||
Stock | Grant Date | |||||||
Restricted Stock Awards | Awards | Fair Value | ||||||
Non-vested at December 31, 2006 | — | $ | — | |||||
Granted | 272,678 | $ | 11.45 | |||||
Vested | — | $ | — | |||||
Forfeited | (2,337 | ) | $ | 11.48 | ||||
Non-vested at December 31, 2007 | 270,341 | $ | 11.45 | |||||
Granted | 210,300 | $ | 8.81 | |||||
Vested | (64,111 | ) | $ | 11.45 | ||||
Forfeited | (16,814 | ) | $ | 11.15 | ||||
Non-vested at December 31, 2008 | 399,716 | $ | 10.30 | |||||
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For the Years Ended December 31, | ||||||
2008 | 2007 | 2006 | ||||
Volatility (range) | 64.1%-67.7% | 67.7%-75.2% | 76.2%-76.3% | |||
Volatility (weighted average) | 66.8% | 69.9% | 76.3% | |||
Risk-free interest rate (weighted average) | 3.0% | 4.0% | 4.7% | |||
Dividend yield | 0% | 0% | 0% | |||
Expected life (years) | 6.25 | 6.07 | 6.25 | |||
Weighted average grant date fair value per option | $5.58 | $7.43 | $4.91 |
For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s) | ||||||||||||
Cost of revenues | $ | 1,522 | $ | 418 | $ | 168 | ||||||
Research and development | 2,262 | 563 | 236 | |||||||||
Selling, general and administrative | 2,033 | 532 | 279 | |||||||||
Total | $ | 5,817 | $ | 1,513 | $ | 683 | ||||||
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16. | STOCKHOLDERS’ EQUITY (DEFICIT) |
17. | EARNINGS PER SHARE |
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For the Years Ended December 31, | ||||||||||||
2008 | 2007 | 2006 | ||||||||||
(In $000’s, except share and per share amounts) | ||||||||||||
Numerator: | ||||||||||||
Net income (loss) | $ | 18,700 | $ | 125,925 | $ | (12,044 | ) | |||||
Denominator: | ||||||||||||
Weighted average common shares outstanding | 59,072,752 | 58,810,452 | 58,996,365 | |||||||||
Effect of dilutive options and and common stock purchase warrants | 1,709,969 | 2,407,018 | — | |||||||||
Diluted weighted average common shares outstanding | 60,782,721 | 61,217,470 | 58,996,365 | |||||||||
Basic net income (loss) per share | $ | 0.32 | $ | 2.14 | $ | (0.20 | ) | |||||
Diluted net income (loss) per share | $ | 0.31 | $ | 2.06 | $ | (0.20 | ) | |||||
18. | SEGMENT INFORMATION |
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Global | Impax | Corporate | Total | |||||||||||||
Year Ended December 31, 2008 | Division | Division | and Other | Company | ||||||||||||
(In $000’s) | ||||||||||||||||
Revenues, net | $ | 197,180 | $ | 12,891 | $ | — | $ | 210,071 | ||||||||
Cost of revenues | 80,724 | 11,245 | — | 91,969 | ||||||||||||
Research and development | 43,502 | 16,307 | — | 59,809 | ||||||||||||
Patent Litigation | 6,472 | — | — | 6,472 | ||||||||||||
Income (loss) before income taxes | $ | 60,944 | $ | (16,198 | ) | $ | (15,075 | ) | $ | 29,671 |
Global | Impax | Corporate | Total | |||||||||||||
Year Ended December 31, 2007 | Division | Division | and Other | Company | ||||||||||||
Revenues, net | $ | 260,994 | $ | 12,759 | $ | — | $ | 273,753 | ||||||||
Cost of revenues | 96,829 | 10,827 | — | 107,656 | ||||||||||||
Research and development | 31,170 | 8,822 | — | 39,992 | ||||||||||||
Patent Litigation | 10,025 | — | — | 10,025 | ||||||||||||
Income (loss) before income taxes | $ | 118,964 | $ | (8,585 | ) | $ | (33,271 | ) | $ | 77,108 |
Global | Impax | Corporate | Total | |||||||||||||
Year Ended December 31, 2006 | Division | Division | and Other | Company | ||||||||||||
Revenues, net | $ | 128,812 | $ | 6,434 | $ | — | $ | 135,246 | ||||||||
Cost of revenues | 66,675 | 5,573 | — | 72,248 | ||||||||||||
Research and development | 24,362 | 5,273 | — | 29,635 | ||||||||||||
Patent Litigation | 9,693 | — | — | 9,693 | ||||||||||||
Income (loss) before income taxes | $ | 25,781 | $ | (6,208 | ) | $ | (31,477 | ) | $ | (11,904 | ) |
19. | COMMITMENTS AND CONTINGENCIES |
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Years Ended | ||||
December 31, | ||||
(In $000s) | ||||
2009 | $ | 1,412 | ||
2010 | 1,265 | |||
2011 | 1,059 | |||
2012 | 1,014 | |||
2013 | 1,024 | |||
Thereafter | 1,032 | |||
Total minimum lease payments | $ | 6,806 | ||
20. | LEGAL AND REGULATORY MATTERS |
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21. | SUBSEQUENT EVENTS |
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22. | SUPPLEMENTARY FINANCIAL INFORMATION (unaudited) |
2008 Quarters Ended: | ||||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||||
(In $000’s except share and per share amounts) | ||||||||||||||||
Revenues: | ||||||||||||||||
Global product sales, gross | $ | 38,990 | $ | 45,703 | $ | 42,343 | $ | 54,544 | ||||||||
Less: | ||||||||||||||||
Chargebacks | 9,233 | 11,033 | 13,770 | 16,108 | ||||||||||||
Rebates | 4,191 | 5,190 | 4,173 | 6,805 | ||||||||||||
Returns | 946 | 1,381 | 1,478 | 1,914 | ||||||||||||
Other credits | 1,163 | 1,474 | 2,213 | 1,906 | ||||||||||||
Global product sales, net | 23,457 | 26,625 | 20,709 | 27,811 | ||||||||||||
RX Partner | 18,805 | 43,870 | 9,424 | 9,679 | ||||||||||||
OTC Partner | 4,409 | 4,932 | 3,398 | 3,207 | ||||||||||||
Research Partner | — | — | — | 833 | ||||||||||||
Promotional Partner | 3,252 | 3,238 | 3,238 | 3,163 | ||||||||||||
Other | 7 | 7 | 5 | 2 | ||||||||||||
Total revenues | 49,930 | 78,672 | 36,774 | 44,695 | ||||||||||||
Gross profit | $ | 26,552 | $ | 57,968 | $ | 14,478 | $ | 19,104 | ||||||||
Net income (loss) | $ | 959 | $ | 17,597 | $ | (8,914 | ) | $ | 9,058 | |||||||
Net income (loss) per share (basic) | $ | 0.02 | $ | 0.30 | $ | (0.15 | ) | $ | 0.15 | |||||||
Net income (loss) per share (diluted) | $ | 0.02 | $ | 0.29 | $ | (0.15 | ) | $ | 0.15 | |||||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic | 58,833,979 | 58,978,703 | 59,166,319 | 59,308,389 | ||||||||||||
Diluted | 61,126,768 | 60,584,709 | 59,166,319 | 60,624,452 | ||||||||||||
• | The Company recognized $1.2 million in income during in the fourth quarter 2008, resulting from the adjustment of the assumptions used to determine the change in the fair value of the common stock purchase warrants. |
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2007 Quarters Ended: | ||||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||||
(In $000’s except share and per share amounts) | ||||||||||||||||
Revenues: | ||||||||||||||||
Global product sales, gross | $ | 32,478 | $ | 33,880 | $ | 42,289 | $ | 39,852 | ||||||||
Less: | ||||||||||||||||
Chargebacks | 7,202 | 7,419 | 10,559 | 8,792 | ||||||||||||
Rebates | 3,375 | 3,520 | 4,306 | 4,767 | ||||||||||||
Returns | 968 | 1,291 | 1,639 | 1,565 | ||||||||||||
Other credits | 1,174 | 1,336 | 1,191 | 1,417 | ||||||||||||
Global product sales, net | 19,759 | 20,314 | 24,594 | 23,311 | ||||||||||||
RX Partner | 8,278 | 33,296 | 81,634 | 37,906 | ||||||||||||
OTC Partner | 2,408 | 2,305 | 4,081 | 3,072 | ||||||||||||
Promotional Partner | 3,201 | 3,279 | 3,104 | 3,175 | ||||||||||||
Other | 17 | 9 | 7 | 3 | ||||||||||||
Total revenues | 33,663 | 59,203 | 113,420 | 67,467 | ||||||||||||
Gross profit | $ | 13,677 | $ | 30,902 | $ | 87,428 | $ | 34,090 | ||||||||
Net income (loss) | $ | (7,770 | ) | $ | 83,792 | $ | 43,402 | $ | 6,501 | |||||||
Net income (loss) per share (basic) | $ | (0.13 | ) | $ | 1.42 | $ | 0.74 | $ | 0.11 | |||||||
Net income (loss) per share (diluted) | $ | (0.13 | ) | $ | 1.37 | $ | 0.71 | $ | 0.11 | |||||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic | 58,794,020 | 58,807,656 | 58,818,971 | 58,821,964 | ||||||||||||
Diluted | 58,794,020 | 61,193,296 | 61,293,615 | 61,301,862 | ||||||||||||
• | As more fully discussed above in the Alliance Agreements footnote, the settlement of a patent infringement lawsuit resulted in the Company being granted a license permitting it to manufacture and sell its oxycodone product (under the terms of the DAVA Agreement), resulting in the Company’s determination to shorten the revenue recognition period of the DAVA Agreement. The license authorized the Company to sell a fixed amount of its product (under a sub-license granted to DAVA) through June 2007. The increased amount of revenue recognized in the third quarter of 2007 resulted from the recognition of these product sales over the resulting revised shorter recognition period. | |
• | As more fully discussed above in the Income Taxes footnote, at June 30, 2007, the Company reversed the valuation allowance on the deferred tax asset, resulting in a significant tax benefit for the second quarter of 2007. |
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For the Year Ended December 31, 2006 | ||||||||||||||||||||
Column A | Column B | Column C | Column D | Column E | ||||||||||||||||
Balance at | Charge to | Charge to | Balance at | |||||||||||||||||
Beginning of | Costs and | Other | End of | |||||||||||||||||
Description | Period | Expenses | Accounts | Deductions | Period | |||||||||||||||
(In $000’s) | ||||||||||||||||||||
Deferred tax asset valuation allowance | $ | 84,970 | $ | 6,992 | $ | — | $ | — | $ | 91,962 | ||||||||||
Inventory reserve | 5,776 | (2,857 | ) | — | — | 2,919 |
For the Year Ended December 31, 2007 | ||||||||||||||||||||
Column A | Column B | Column C | Column D | Column E | ||||||||||||||||
Balance at | Charge to | Charge to | Balance at | |||||||||||||||||
Beginning of | Costs and | Other | End of | |||||||||||||||||
Description | Period | Expenses | Accounts | Deductions | Period | |||||||||||||||
(In $000’s) | ||||||||||||||||||||
Deferred tax asset valuation allowance | $ | 91,962 | $ | (81,485 | ) | $ | (10,477 | ) | $ | — | $ | — | ||||||||
Inventory reserve | 2,919 | 229 | — | — | 3,148 | |||||||||||||||
Reserve for bad debts | — | 550 | — | — | 550 |
For the Year Ended December 31, 2008 | ||||||||||||||||||||
Column A | Column B | Column C | Column D | Column E | ||||||||||||||||
Balance at | Charge to | Charge to | Balance at | |||||||||||||||||
Beginning of | Costs and | Other | End of | |||||||||||||||||
Description | Period | Expenses | Accounts | Deductions | Period | |||||||||||||||
(In $000’s) | ||||||||||||||||||||
Deferred tax asset valuation allowance | $ | — | $ | 333 | $ | — | $ | — | $ | 333 | ||||||||||
Inventory reserve | 3,148 | 1,257 | — | — | 4,405 | |||||||||||||||
Reserve for bad debts | 550 | 568 | — | (290 | ) | 828 |
S-1
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Date: March 12, 2009 | By: /s/ Larry Hsu, Ph.D. Name: Larry Hsu, Ph.D. Title: President and Chief Executive Officer |
Signature | Title | Date | ||||
/s/ Larry Hsu, Ph.D Larry Hsu, Ph.D | President, Chief Executive Officer (Principal Executive Officer) and Director | March 12, 2009 | ||||
/s/ Arthur A. Koch, Jr. Arthur A. Koch, Jr. | Senior Vice President, Finance, and Chief Financial Officer (Principal Financial and Accounting Officer) | March 12, 2009 | ||||
/s/ Leslie Z. Benet, Ph.D. Leslie Z. Benet, Ph.D. | Director | March 12, 2009 | ||||
/s/ Robert L. Burr Robert L. Burr | Chairman of the Board | March 12, 2009 | ||||
/s/ Nigel Ten Fleming, Ph.D. Nigel Ten Fleming, Ph.D. | Director | March 12, 2009 | ||||
/s/ Michael Markbreiter Michael Markbreiter | Director | March 12, 2009 | ||||
/s/ Oh Kim Sun Oh Kim Sun | Director | March 12, 2009 | ||||
/s/ Peter R. Terreri Peter R. Terreri | Director | March 12, 2009 |
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Exhibit | ||||
No. | Description of Document | |||
3 | .1.1 | Restated Certificate of Incorporation, dated August 30, 2004.(1) | ||
3 | .1.2 | Certificate of Designation of Series A Junior Participating Preferred Stock, as filed with the Secretary of State of Delaware on January 21, 2009.(3) | ||
3 | .2 | By-Laws.(2) | ||
4 | .1 | Specimen of Common Stock Certificate.(2) | ||
4 | .2 | Form of Debenture (incorporated by reference to Exhibit A to the Indenture, dated as of June 27, 2005, between the Company and HSBC Bank USA, National Association, as Trustee, listed on Exhibit 4.3) | ||
4 | .3 | Indenture, dated as of June 27, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(2) | ||
4 | .4 | Supplemental Indenture, dated as of July 6, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(2) | ||
4 | .5 | Registration Rights Agreement, dated as of June 27, 2005, between the Company and the Initial Purchasers named therein.(2) | ||
4 | .6 | Promissory Note dated June 7, 2006, issued by the Company to Solvay Pharmaceuticals, Inc.(2) | ||
4 | .7 | Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(3) | ||
10 | .1 | Amended and Restated Loan and Security Agreement, dated as of December 15, 2005, between the Company and Wachovia Bank, National Association.(2) | ||
10 | .1.1 | First Amendment, dated October 14, 2008, to Amended and Restated Loan and Security Agreement, dated December 15, 2005, between the Company and Wachovia Bank, National Association.(4) | ||
10 | .1.2 | Second Amendment to Amended and Restated Loan and Security Agreement, effective as of December 31, 2008, by and among the Company and Wachovia Bank, National Association. | ||
10 | .2 | Purchase Agreement, dated June 26, 2005, between the Company and the Purchasers named therein.(2) | ||
10 | .3 | Impax Laboratories Inc. 1995 Stock Incentive Plan.*(2) | ||
10 | .3.1 | Amendment No. 1 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated July 1, 1998.* | ||
10 | .3.2 | Amendment No. 2 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated May 25, 1999.* | ||
10 | .4 | Impax Laboratories Inc. 1999 Equity Incentive Plan.* | ||
10 | .4.1 | Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.* | ||
10 | .5 | Impax Laboratories Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(2) | ||
10 | .6 | Impax Laboratories Inc. Amended and Restated 2002 Equity Incentive Plan.* | ||
10 | .6.1 | Form of Stock Option Grant under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.* | ||
10 | .6.2 | Form of Stock Bonus Agreement under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.* | ||
10 | .7 | Impax Laboratories Inc. Executive Non-Qualified Deferred Compensation Plan, restated effective January 1, 2005.*(4) | ||
10 | .8 | Employment Agreement, dated as of December 14, 1999, between the Company and Charles Hsiao, Ph.D.*(4) | ||
10 | .9 | Employment Agreement, dated as of December 14, 1999, between the Company and Larry Hsu, Ph.D.*(4) | ||
10 | .10 | Offer of Employment Letter, dated August 12, 2004, between the Company and Charles V. Hildenbrand.* | ||
10 | .11 | Offer of Employment Letter, dated February 9, 2005, between the Company and Arthur A. Koch, Jr.* | ||
10 | .12.1 | Employment Agreement, dated as of September 1, 2006, between the Company and David S. Doll.*(2) | ||
10 | .12.2 | Separation Agreement and General Release, dated July 30, 2008, between the Company and David S. Doll.*(2) | ||
10 | .12.3 | Consulting Agreement, effective as of September 4, 2008, between the Company and David S. Doll.*(2) | ||
10 | .13 | Offer of Employment Letter, effective as of March 31, 2008, between the Company and Michael Nestor.* |
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Exhibit | ||||
No. | Description of Document | |||
10 | .14 | Offer of Employment Letter, effective as of January 5, 2009, between the Company and Christopher Mengler.* | ||
10 | .15 | Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.1 | Letter Amendment, dated October 8, 2003, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.2 | Letter Agreement, dated March 24, 2005, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.3 | Letter Amendment, dated March 24, 2005 and effective January 1, 2005, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .15.4 | Amendment, dated January 24, 2006, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(6) | ||
10 | .15.5 | Amendment, dated February 9, 2007, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(5) | ||
10 | .16 | Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.**(5) | ||
10 | .16.1 | Amendment, dated as of July 9, 2004, to Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.(6) | ||
10 | .16.2 | Amendment, dated as of February 14, 2005, to Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.(6) | ||
10 | .17 | Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(6) | ||
10 | .17.1 | Amendment No. 3, effective as of July 23, 2004, to Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(5) | ||
10 | .17.2 | Amendment No. 4, effective as of December 15, 2006, to Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering Corporation.**(5) | ||
10 | .18 | Supply and Distribution Agreement, dated as of November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(5) | ||
10 | .18.1 | Amendment No. 2, dated February 6, 2007, to Supply and Distribution Agreement, dated November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(6) | ||
10 | .19 | Patent License Agreement, dated as of March 30, 2007, by and among Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P. and the Company.(7) | ||
10 | .20 | Supplemental License Agreement, dated as of March 30, 2007, by and among Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P. and the Company.(7) | ||
10 | .21 | Sublicense Agreement, effective as of March 30, 2007, between the Company and DAVA Pharmaceuticals, Inc.(7) | ||
10 | .22 | Promotional Services Agreement, dated as of January 19, 2006, between the Company and Shire US Inc.**(5) | ||
10 | .23 | Co-promotion Agreement, dated as of July 16, 2008, between the Company and Wyeth, acting through its Wyeth Pharmaceuticals Division.**(7) | ||
10 | .24 | Joint Development Agreement, dated as of November 26, 2008, between the Company and Medicis Pharmaceutical Corporation.**(5) | ||
10 | .25 | Special Cash Bonus Payments and Directors Fees.*(8) | ||
10 | .26 | Construction Work Agreement, dated as of February 18, 2008, by and between Impax Laboratories (Taiwan), Inc., a wholly-owned subsidiary of the Company, and E&C Engineering Corporation (English translation from the Taiwanese language). | ||
10 | .27 | Construction Agreement, dated as of March 11, 2008, by and between Impax Laboratories (Taiwan), Inc., a wholly-owned subsidiary of the Company, and Fu Tsu Construction (English translation from the Taiwanese language). |
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Exhibit | ||||
No. | Description of Document | |||
11 | .1 | Statement re computation of per share earnings (incorporated by reference to Note 17 to the Notes to the Consolidated Financial Statements in this Annual Report onForm 10-K). | ||
21 | .1 | Subsidiaries of the registrant. | ||
31 | .1 | Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||
31 | .2 | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | ||
32 | .1 | Certifications of the Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* | Management contract, compensatory plan or arrangement. | |
** | Confidential treatment requested for certain portions of this exhibit pursuant toRule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
(1) | Incorporated by reference to Amendment No. 5 to the Company’s Registration Statement on Form 10 filed on December 23, 2008. | |
(2) | Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008. | |
(3) | Incorporated by reference to the Company’s Current Report onForm 8-K filed on January 22, 2009. | |
(4) | Incorporated by reference to Amendment No. 2 to the Company’s Registration Statement on Form 10 filed on December 2, 2008. | |
(5) | Incorporated by reference to Amendment No. 6 to the Company’s Registration Statement on Form 10 filed on January 14, 2009. | |
(6) | Incorporated by reference to Amendment No. 1 to the Company’s Registration Statement on Form 10 filed on November 12, 2008. | |
(7) | Incorporated by reference to Amendment No. 7 to the Company’s Registration Statement on Form 10 filed on January 21, 2009. | |
(8) | Incorporated by reference to the Company’s Current Report onForm 8-K filed on January 6, 2009. |