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þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 65-0403311 | |
(State or other jurisdiction of incorporation | (I.R.S. Employer Identification No.) | |
or organization) | ||
30831 Huntwood Avenue, Hayward, CA | 94544 | |
(Address of principal executive offices) | (Zip Code) |
(510) 476-2000
Title of each class | Name of each exchange on which registered: | |
Common Stock, par value $0.01 per share | The NASDAQ Stock Market LLC | |
Series A Junior Participating Preferred Stock Purchase Rights | The NASDAQ Stock Market LLC |
Large accelerated filero | Accelerated filerþ | Non-accelerated filero | Smaller reporting companyo | |||
(Do not check if a smaller reporting company) |
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Exhibit 10.22 | ||||||||
Exhibit 10.24 | ||||||||
Exhibit 21.1 | ||||||||
Exhibit 23.1 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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• | 57 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®, Wellbutrin XL®, Ditropan XL®, Depakote ER® and Prilosec®. |
• | 32 applications pending at the FDA, including 5 tentatively approved (i.e., satisfying substantive FDA requirements but remaining subject to statutory pre-approval restrictions), that address approximately $20.4 billion in recent 12 month U.S. product sales. |
• | 52 products in various stages of development for which applications have not yet been filed. |
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Product | Generic of | |
2004 OR EARLIER | ||
Orphenadrine 100 mg Tablets | Norflex® | |
Omeprazole 10 and 20 mg Capsules (1c) | Prilosec® | |
Minocycline 50, 75 and 100 mg Capsules | Minocin® | |
Terbutaline 2.5 and 5 mg Tablets | Brethine® | |
Fludrocortisone 0.1 mg Tablets | Florinef® | |
Rimantadine 100 mg Tablets | Flumadine® | |
Pyridostigmine 60 mg Tablets | Mestinon® | |
Chloroquine 250 mg Tablets | N/A | |
Chloroquine 500 mg Tablets | Aralen® | |
Flavoxate 100 mg Tablets | Urispas® | |
Fenofibrate 67, 134 and 200 mg Capsules | Lofibra® | |
Loratadine and Pseudoephedrine Sulfate 5/120 mg ER Tablets | Claritin-D 12-hr® | |
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® | |
Bupropion Hydrochloride 200 mg ER Tablets (twice daily) | Wellbutrin SR® | |
2005 | ||
Dantrolene Sodium 25, 50 and 100 mg Capsules | Dantrium® | |
Carprofen 25, 75 and 100 mg Caplets (a veterinary product) | Rimadyl® | |
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® | |
Bethanechol Chloride 5, 10, 25 and 50 mg Tablets (4 separate ANDAs) | Urecholine® | |
Oxybutynin Chloride 15 mg ER Tablets (1a) | Ditropan XL® | |
Bupropion Hydrochloride 300 mg ER Tablets (1b) (once daily) | Wellbutrin XL® | |
2007 | ||
Nadolol /Bendroflumethiazide 40/5 and 80/5 mg Tablets | Corzide® | |
Oxybutynin Chloride 5 and 10 mg ER Tablets (1a) | Ditropan XL® | |
Dipyridamole 25, 50, 75 mg Tablets USP | Persantine® | |
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® | |
Bupropion Hydrochloride 150 mg ER Tablets (1b) (once daily) | Wellbutrin XL® | |
2009 | ||
Omeprazole 40 mg Capsules (1c) | Prilosec® | |
Divalproex Sodium ER 250 and 500 mg Tablets | Depakote® ER | |
Galantamine 8 and 16 mg Capsules | Razadyne® ER |
(1) | Multiple products filed under same ANDA, including (i) 1a: Oxybutynin Chloride products, (ii) 1b: Bupropion Hydrochloride products, and (iii) 1c: Omeprazole products. |
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Product | Generic of | |
Cyclobenzaprine CD 15 and 30 mg Capsules | Amrix® | |
Doxycycline Hyclate DR 75, and 100 mg Tablets | Doryx® | |
Doxycycline Hyclate DR 150 mg Tablets | Doryx® | |
Doxycycline USP 40mg Capsules | Oracea® | |
Ropinirole ER 2, 3, 4, 6, 8, 12mg Tablets | Requip XL® | |
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® | |
Fenofibrate 48 and 145mg Tablets | Tricor® | |
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® | |
Sevelamer HCI 400 and 800mg Tablets | Renagel® | |
Sevelamer Carbonate 800mg Tablets | Renvela® | |
Colesevelam 625 mg Tablets | Welchol® | |
Tamsulosin Hydrochloride 0.4 mg Capsules | Flomax® |
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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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Year Ended December 31, | ||||||||||||||||||||||||
$’s in 000’s | 2009 | 2008 | 2007 | |||||||||||||||||||||
Gross Revenue and % Gross Revenue | ||||||||||||||||||||||||
Teva Agreement | $ | 33,821 | 6 | % | $ | 40,947 | 14 | % | $ | 42,480 | 13 | % | ||||||||||||
Dava Agreement | $ | — | — | % | $ | 40,831 | 14 | % | $ | 118,634 | 35 | % | ||||||||||||
Putney Agreement | $ | 14 | — | % | $ | — | — | % | $ | — | — | % | ||||||||||||
Sub-Total: Rx Partner | $ | 33,835 | 6 | % | $ | 81,778 | 28 | % | $ | 161,114 | 48 | % | ||||||||||||
OTC Partner | $ | 6,842 | 1 | % | $ | 15,946 | 5 | % | $ | 11,866 | 4 | % |
• | 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 mg 12-hour extended release tablets |
• | Claritin-D® 24-hour 240 mg 24-hour extended release tablets |
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• | 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. | 56 | Senior Vice President, Finance, and Chief Financial Officer | ||||
Charles V. Hildenbrand | 58 | Senior Vice President, Operations | ||||
Christopher Mengler, R.Ph | 47 | President, Global Pharmaceuticals Division | ||||
Michael J. Nestor | 57 | President, Impax Pharmaceuticals Division |
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• | the timing of FDA approvals we receive; |
• | the timing of process validation for particular generic drug products; |
• | 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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• | 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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• | 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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• | 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. |
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Because of the location of our manufacturing and research and development facilities, our operations could be interrupted by an earthquake or be susceptible to climate changes.
Our corporate headquarters in California, manufacturing operations in California and Taiwan, and research and development activities related to process technologies are located near major earthquake fault lines. Although we have other facilities, we produce a substantial portion of our products at our California facility. A disruption at these California facilities due to an earthquake, other natural disaster, or due to climate changes, even on a short-term basis, could impair our ability to produce and ship products to the market on a timely basis. In addition, we could experience a destruction of facilities which would be costly to rebuild, or loss of life, all of which could materially adversely affect our business and results of operations.
We presently carry $ 10.0 million of earthquake coverage which covers all of our facilities on a worldwide basis. We carry an additional $ 30.0 million of earthquake coverage specifically for our California facilities. We believe the aggregate amount of earthquake coverage we currently carry is appropriate in light of the risks; however, the amount of our earthquake insurance coverage may not be sufficient to cover losses from earthquakes. We may discontinue some or all of this insurance coverage in the future if the cost of premiums exceeds the value of the coverage discounted for the risk of loss. If we experience a loss which is uninsured or which exceeds policy limits, we could lose the capital invested in the damaged facilities, as well as the anticipated future net sales from those facilities.
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• | our ability to maintain compliance with SEC reporting requirements; |
• | our ability to maintain the listing of our common stock on The NASDAQ Stock Market LLC; |
• | 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. |
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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, 2009 | ||||||||
First Quarter | $ | 7.74 | $ | 2.50 | ||||
Second Quarter | $ | 7.59 | $ | 4.89 | ||||
Third Quarter | $ | 9.10 | $ | 7.02 | ||||
Fourth Quarter | $ | 13.87 | $ | 8.59 | ||||
Year Ended 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 |
• | any beneficial owners of common stock whose shares are held in the names of various dealers, clearing agencies, banks, brokers and other fiduciaries; and |
• | broker-dealers or other participants who hold or clear shares directly or indirectly through the Depository Trust Company, or its nominee, Cede & Co. |
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Total | ||||||||||||||
Number of | ||||||||||||||
Shares (or | Maximum | |||||||||||||
Units) | Number (or | |||||||||||||
Purchased | Approximate Dollar | |||||||||||||
as Part of | Value) of Shares (or | |||||||||||||
Publicly | Units) that May Yet | |||||||||||||
Total | Average | Announced | Be Purchased Under | |||||||||||
Number of Shares | Price Paid Per | Plans or | the Plans or | |||||||||||
Period | (or Units) Purchased(1) | Share (or Unit) | Programs | Programs | ||||||||||
October 1, 2009 to October 31, 2009 | 11,692 shares of common stock | $ | 9.32 | — | — | |||||||||
November 1, 2009 to November 30, 2009 | 8,813 shares of common stock | $ | 11.49 | — | — | |||||||||
December 1, 2009 to December 31, 2009 | 4,637 shares of common stock | $ | 12.65 | — | — |
(1) | Represents shares of our common stock that we accepted during the indicated periods as a tax withholding from certain of our employees in connection with the vesting of shares of restricted stock pursuant to the terms of our Amended and Restated 2002 Equity Incentive Plan (the “2002 Plan”). |
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Number of | ||||||||||||
Securities | ||||||||||||
Remaining | ||||||||||||
Available for | ||||||||||||
Number of | Future Issuance | |||||||||||
Securities to be | Under Equity | |||||||||||
Issued Upon | Weighted Average | Compensation | ||||||||||
Exercise of | Exercise Price of | Plans (Excluding | ||||||||||
Outstanding | Outstanding | Securities reflected | ||||||||||
Options, Warrants | Options, Warrants | in | ||||||||||
and Rights | and Rights | Column (a)) | ||||||||||
Plan Category | (a) | (b) | (c) | |||||||||
Equity compensation plans approved by security holders | 8,229,818 | (1) | $ | 9.87 | 1,378,639 | |||||||
Equity compensation plans not approved by security holders | — | — | 363,041 | (2) | ||||||||
Total: | 8,229,818 | $ | 9.87 | 1,741,680 | ||||||||
(1) | Represents options issued pursuant to the 2002 Plan, and the Impax Laboratories Inc. 1999 Equity Incentive Plan. | |
(2) | Represents 363,041 shares of common stock available for future issuance under the Impax Laboratories, Inc. 2001 Non-Qualified Employee Stock Purchase Plan. |
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For the Years Ended December 31 | ||||||||||||||||||||
($ in 000s, except per share data) | 2009 | 2008 | 2007 | 2006 | 2005 | |||||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||||||
Statements of Operations Data: | ||||||||||||||||||||
Total revenues | $ | 358,409 | $ | 210,071 | $ | 273,753 | $ | 135,246 | $ | 112,400 | ||||||||||
Research and development | 63,274 | 59,237 | 39,992 | 29,635 | 26,095 | |||||||||||||||
Total operating expenses | 117,683 | 114,179 | 89,590 | 74,245 | 59,588 | |||||||||||||||
Income (loss) from operations | 70,413 | 3,923 | 76,507 | (11,247 | ) | (5,623 | ) | |||||||||||||
Net income (loss) | 50,061 | 15,987 | 125,410 | (12,044 | ) | (5,780 | ) | |||||||||||||
Net income (loss) per share — basic | $ | 0.83 | $ | 0.27 | $ | 2.13 | $ | (0.20 | ) | $ | (0.10 | ) | ||||||||
Net income (loss) per share — diluted | $ | 0.82 | $ | 0.26 | $ | 2.05 | $ | (0.20 | ) | $ | (0.10 | ) |
As of December 31 | ||||||||||||||||||||
($ in 000s) | 2009 | 2008 | 2007 | 2006 | 2005 | |||||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||||||
Balance Sheet Data: | ||||||||||||||||||||
Cash, cash equivalents and short-term investments | $ | 90,369 | $ | 119,985 | $ | 143,496 | $ | 29,834 | $ | 56,081 | ||||||||||
Working capital | 170,143 | 126,784 | 110,108 | 81,919 | 55,796 | |||||||||||||||
Total assets | 660,756 | 514,287 | 513,745 | 343,888 | 260,285 | |||||||||||||||
Long-term debt | — | 5,990 | 16,061 | 89,603 | 80,285 | |||||||||||||||
Total liabilities | 438,529 | 354,637 | 377,697 | 347,864 | 251,399 | |||||||||||||||
Retained earnings (deficit) | 828 | (49,233 | ) | (65,220 | ) | (186,215 | ) | (174,171 | ) | |||||||||||
Total stockholders’ equity (deficit) | $ | 222,227 | $ | 159,650 | $ | 136,048 | $ | (3,976 | ) | $ | 8,886 |
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As of December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
($ in 000s) | ||||||||||||
Chargeback reserve | ||||||||||||
Beginning balance | $ | 4,056 | $ | 2,977 | $ | 4,401 | ||||||
Provision recorded during the period | 126,105 | 50,144 | 33,972 | |||||||||
Credits issued during the period | (108,713 | ) | (49,065 | ) | (35,396 | ) | ||||||
Ending balance | $ | 21,448 | $ | 4,056 | $ | 2,977 | ||||||
Provision as a percent of Global product sales, gross | 24 | % | 28 | % | 23 | % |
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As of December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
($ in 000s) | ||||||||||||
Rebate reserve | ||||||||||||
Beginning balance | $ | 4,800 | $ | 3,603 | $ | 3,124 | ||||||
Provision recorded during the period | 72,620 | 20,361 | 15,968 | |||||||||
Credits issued during the period | (39,639 | ) | (19,164 | ) | (15,489 | ) | ||||||
Ending balance | $ | 37,781 | $ | 4,800 | $ | 3,603 | ||||||
Provision as a percent of Global product sales, gross | 14 | % | 11 | % | 11 | % |
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As of December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
($ in 000s) | ||||||||||||
Returns reserve | ||||||||||||
Beginning balance | $ | 13,675 | $ | 14,261 | $ | 12,903 | ||||||
Provision recorded during the period | 11,847 | 5,719 | 5,459 | |||||||||
Credits issued during the period | (3,408 | ) | (6,305 | ) | (4,101 | ) | ||||||
Ending balance | $ | 22,114 | $ | 13,675 | $ | 14,261 | ||||||
Provision as a percent of Global product sales, gross | 2 | % | 3 | % | 4 | % |
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2009 | 2008 | $ | % | ||||||||||||
(as adjusted) | ||||||||||||||||
Total revenues | $ | 358,409 | $ | 210,071 | $ | 148,338 | 71 | % | ||||||||
Gross profit | 188,096 | 118,102 | 69,994 | 59 | % | |||||||||||
Income from operations | 70,413 | 3,923 | 66,490 | nm | ||||||||||||
Income before income taxes | 70,977 | 26,009 | 44,968 | 173 | % | |||||||||||
Provision for income taxes | 21,006 | 10,069 | 10,937 | 109 | % | |||||||||||
49,971 | 15,940 | 34,031 | 213 | % | ||||||||||||
Non-controlling interest | 90 | 47 | 43 | 91 | % | |||||||||||
Net income | $ | 50,061 | $ | 15,987 | $ | 34,074 | 213 | % | ||||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2009 | 2008 | $ | % | ||||||||||||
(as adjusted) | ||||||||||||||||
Revenues | ||||||||||||||||
Global product sales, net | $ | 287,079 | $ | 96,006 | $ | 191,073 | 199 | % | ||||||||
Private Label product sales | 5,513 | 2,596 | 2,917 | 112 | % | |||||||||||
Rx Partner | 33,835 | 81,778 | (47,943 | ) | (59 | )% | ||||||||||
OTC Partner | 6,842 | 15,946 | (9,104 | ) | (57 | )% | ||||||||||
Research Partner | 11,680 | 833 | 10,847 | nm | ||||||||||||
Other | 12 | 21 | (9 | ) | (43 | )% | ||||||||||
Total revenues | 344,961 | 197,180 | 147,781 | 75 | % | |||||||||||
Cost of revenues | 158,270 | 80,724 | 77,546 | 96 | % | |||||||||||
Gross profit | 186,691 | 116,456 | 70,235 | 60 | % | |||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 38,698 | 42,930 | (4,232 | ) | (10 | )% | ||||||||||
Patent litigation | 5,379 | 6,472 | (1,093 | ) | (17 | )% | ||||||||||
Selling, general and administrative | 10,891 | 11,445 | (554 | ) | (5 | )% | ||||||||||
Total operating expenses | 54,968 | 60,847 | (5,879 | ) | (10 | )% | ||||||||||
Income from operations | $ | 131,723 | $ | 55,609 | 76,114 | 137 | % | |||||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2009 | 2008 | $ | % | ||||||||||||
(as adjusted) | ||||||||||||||||
Promotional Partner revenue | $ | 13,448 | $ | 12,891 | 557 | 4 | % | |||||||||
Cost of revenues | 12,043 | 11,245 | 798 | 7 | % | |||||||||||
Gross profit | 1,405 | 1,646 | (241 | ) | (15 | )% | ||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 24,576 | 16,307 | 8,269 | 51 | % | |||||||||||
Selling, general and administrative | 3,469 | 2,671 | 798 | 30 | % | |||||||||||
Total operating expenses | 28,045 | 18,978 | 9,067 | 48 | % | |||||||||||
Loss from operations | $ | (26,640 | ) | $ | (17,332 | ) | (9,308 | ) | (54 | )% | ||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2009 | 2008 | $ | % | ||||||||||||
(as adjusted) | ||||||||||||||||
Litigation settlement | $ | 9,318 | $ | — | 9,318 | nm | ||||||||||
General and administrative expenses | 25,352 | 34,354 | (9,002 | ) | (26 | )% | ||||||||||
Total operating expenses | 34,670 | 34,354 | 316 | 1 | % | |||||||||||
Loss from operations | (34,670 | ) | (34,354 | ) | (316 | ) | (1 | )% | ||||||||
Change in fair value of common stock purchase warrant | — | 1,234 | (1,234 | ) | (100 | )% | ||||||||||
Other income, net | 57 | 21,529 | (21,472 | ) | (100 | )% | ||||||||||
Loss on repurchase of 3.5% Debentures | — | (113 | ) | 113 | 100 | % | ||||||||||
Interest income | 753 | 4,218 | (3,465 | ) | (82 | )% | ||||||||||
Interest expense | (246 | ) | (4,782 | ) | 4,536 | 95 | % | |||||||||
Loss before income taxes | (34,106 | ) | (12,268 | ) | (21,838 | ) | (178 | )% | ||||||||
Provision for income taxes | $ | 21,006 | $ | 10,069 | 10,937 | 109 | % |
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2008 | 2007 | $ | % | ||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||
Total revenues | $ | 210,071 | $ | 273,753 | $ | (63,682 | ) | (23 | )% | |||||||
Gross profit | 118,102 | 166,097 | (47,995 | ) | (29 | )% | ||||||||||
Income from operations | 3,923 | 76,507 | (72,584 | ) | (95 | )% | ||||||||||
Income before income taxes | 26,009 | 73,997 | (47,988 | ) | (65 | )% | ||||||||||
Provision (benefit) for income taxes | 10,069 | (51,351 | ) | 61,420 | nm | |||||||||||
15,940 | 125,348 | (109,408 | ) | (87 | )% | |||||||||||
Non-controlling interest | 47 | 62 | (15 | ) | (24 | )% | ||||||||||
Net income | $ | 15,987 | $ | 125,410 | $ | (109,423 | ) | (87 | )% | |||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2008 | 2007 | $ | % | ||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||
Revenues | ||||||||||||||||
Global product sales, net | $ | 96,006 | $ | 85,037 | $ | 10,969 | 13 | % | ||||||||
Private Label product sales | 2,596 | 2,941 | (345 | ) | (12 | )% | ||||||||||
Rx Partner | 81,778 | 161,114 | (79,336 | ) | (49 | )% | ||||||||||
OTC Partner | 15,946 | 11,866 | 4,080 | 34 | % | |||||||||||
Research Partner | 833 | — | 833 | nm | ||||||||||||
Other | 21 | 36 | (15 | ) | (42 | )% | ||||||||||
Total revenues | 197,180 | 260,994 | (63,814 | ) | (24 | )% | ||||||||||
Cost of revenues | 80,724 | 96,829 | (16,105 | ) | (17 | )% | ||||||||||
Gross profit | 116,456 | 164,165 | (47,709 | ) | (29 | )% | ||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 42,930 | 31,170 | 11,760 | 38 | % | |||||||||||
Patent litigation | 6,472 | 10,025 | (3,553 | ) | (35 | )% | ||||||||||
Selling, general and administrative | 11,445 | 7,076 | 4,369 | 62 | % | |||||||||||
Total operating expenses | 60,847 | 48,271 | 12,576 | 26 | % | |||||||||||
Income from operations | $ | 55,609 | $ | 115,894 | (60,285 | ) | (52 | )% | ||||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2008 | 2007 | $ | % | ||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||
Promotional Partner revenue | $ | 12,891 | $ | 12,759 | 132 | 1 | % | |||||||||
Cost of revenues | 11,245 | 10,827 | 418 | 4 | % | |||||||||||
Gross profit | 1,646 | 1,932 | (286 | ) | (15 | )% | ||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 16,307 | 8,822 | 7,485 | 85 | % | |||||||||||
Selling, general and administrative | 2,671 | 1,696 | 975 | 57 | % | |||||||||||
Total operating expenses | 18,978 | 10,518 | 8,460 | 80 | % | |||||||||||
Loss from operations | $ | (17,332 | ) | $ | (8,586 | ) | (8,746 | ) | (102 | )% | ||||||
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Year Ended | Increase/ | |||||||||||||||
December 31 | December 31 | (Decrease) | ||||||||||||||
(in $000’s) | 2008 | 2007 | $ | % | ||||||||||||
(as adjusted) | (as adjusted) | |||||||||||||||
General and administrative expenses | $ | 34,354 | $ | 30,801 | 3,553 | 12 | % | |||||||||
Loss from operations | (34,354 | ) | (30,801 | ) | (3,553 | ) | (12 | )% | ||||||||
Change in fair value of common stock purchase warrant | 1,234 | (110 | ) | 1,344 | nm | |||||||||||
Other income, net | 21,529 | 11 | 21,518 | nm | ||||||||||||
Loss on repurchase of 3.5% Debentures | (113 | ) | — | (113 | ) | nm | ||||||||||
Interest income | 4,218 | 4,751 | (533 | ) | (11 | )% | ||||||||||
Interest expense | (4,782 | ) | (7,162 | ) | 2,380 | 33 | % | |||||||||
Provision for income taxes | $ | 10,069 | $ | (51,351 | ) | 61,420 | nm |
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Payments Due by Period | ||||||||||||||||||||
Less | More | |||||||||||||||||||
Than 1 | 1-3 | 3-5 | Than 5 | |||||||||||||||||
($ in 000s) | Total | Year | Years | Years | Years | |||||||||||||||
Contractual Obligations (a) | ||||||||||||||||||||
Credit Facilities and Long-Term Debt | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
Interest Expense Payable — Long-Term Debt | — | — | — | — | — | |||||||||||||||
Open Purchase Order Commitments | 22,078 | 22,078 | — | — | — | |||||||||||||||
Operating Leases(b) | 5,403 | 1,275 | 3,097 | 819 | 212 | |||||||||||||||
Construction Contracts(c) | 1,355 | 1,355 | — | — | — | |||||||||||||||
Total | $ | 28,836 | $ | 24,708 | $ | 3,097 | $ | 819 | $ | 212 | ||||||||||
(a) | Liabilities for uncertain tax positions FASB ASC Topic 740, Sub-topic 10, were excluded as we are not able to make a reasonably reliable estimate of the amount and period of related future payments. As of December 31, 2009, we had a $1.2 million provision for uncertain tax positions. | |
(b) | 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. | |
(c) | Construction contracts are related to our 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 was completed and equipment was installed, validated, and approved by the FDA in 2009; we expect shipments of commercial product to begin in early 2010. In conjunction with the construction of our Taiwan facility, we entered into several contracts, amounting to an aggregate of approximately $16.6 million as of December 31, 2009 and 2008. As of December 31, 2009 and 2008, we had remaining commitments under these contracts of approximately $1.4 million and $2.0 million, 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 |
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Board of Directors and Stockholders
Impax Laboratories, Inc.
We have audited Impax Laboratories, Inc. and Subsidiaries’ (a Delaware corporation) (the “Company”) internal control over financial reporting as of December 31, 2009, based on criteria established inInternal Control-Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Impax Laboratories, Inc. and Subsidiaries maintained, in all material respects, effective internal control over financial reporting as of December 31, 2009, based on criteria established inInternal Control-Integrated Frameworkissued by COSO.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Impax Laboratories, Inc. and Subsidiaries as of December 31, 2009 and 2008 and the related consolidated statements of operations, changes in stockholders’ equity (deficit), comprehensive income and cash flows for each of the three years in the period ended December 31, 2009 and our report dated February 26, 2010 expressed an unqualified opinion.
/s/ GRANT THORNTON LLP
Philadelphia, Pennsylvania
February 26, 2010
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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.(2) | |||
3.2 | Amended and Restated Bylaws, effective June 29, 2009.(3) | |||
4.1 | Specimen of Common Stock Certificate.(4) | |||
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.(4) | |||
4.4 | Supplemental Indenture, dated as of July 6, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(4) | |||
4.5 | Registration Rights Agreement, dated as of June 27, 2005, between the Company and the Initial Purchasers named therein.(4) | |||
4.6 | Promissory Note dated June 7, 2006, issued by the Company to Solvay Pharmaceuticals, Inc.(4) | |||
4.7 | Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(2) | |||
10.1.1 | Amended and Restated Loan and Security Agreement, dated as of December 15, 2005, between the Company and Wachovia Bank, National Association.(4) | |||
10.1.2 | 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.(5) | |||
10.1.3 | 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.(6) | |||
10.1.4 | Third Amendment to Amended and Restated Loan and Security Agreement, effective as of March 31, 2009, by and among the Company and Wachovia Bank, National Association.(7) | |||
10.2 | Purchase Agreement, dated June 26, 2005, between the Company and the Purchasers named therein.(4) | |||
10.3.1 | Impax Laboratories Inc. 1995 Stock Incentive Plan.*(4) | |||
10.3.2 | Amendment No. 1 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated July 1, 1998.*(6) | |||
10.3.3 | Amendment No. 2 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated May 25, 1999.*(6) | |||
10.4.1 | Impax Laboratories Inc. 1999 Equity Incentive Plan.*(6) | |||
10.4.2 | Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(6) | |||
10.5 | Impax Laboratories Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(4) | |||
10.6.1 | Impax Laboratories Inc. Amended and Restated 2002 Equity Incentive Plan.*(8) | |||
10.6.2 | Form of Stock Option Grant under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.*(6) | |||
10.6.3 | Form of Stock Bonus Agreement under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.*(6) | |||
10.6.4 | Amendment to Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan, effective May 19, 2009.*(9) | |||
10.7 | Impax Laboratories Inc. Executive Non-Qualified Deferred Compensation Plan, restated effective January 1, 2005.*(5) | |||
10.8.1 | Employment Agreement, dated December 14, 1999, by and between the Company and Larry Hsu, Ph.D.*(5) |
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Exhibit No. | Description of Document | |||
10.8.2 | Amendment No. 1, dated May 19, 2009, to Employment Agreement, dated December 14, 1999, by and between the Company and Larry Hsu, Ph.D.*(9) | |||
10.8.3 | Employment Agreement, dated as of January 1, 2010, between the Company and Larry Hsu, Ph.D.*(10) | |||
10.9.1 | Offer of Employment Letter, dated August 12, 2004, between the Company and Charles V. Hildenbrand.*(6) | |||
10.9.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Charles V. Hildenbrand.*(10) | |||
10.10.1 | Offer of Employment Letter, dated February 9, 2005, between the Company and Arthur A. Koch, Jr.*(6) | |||
10.10.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Arthur A. Koch, Jr.*(10) | |||
10.11.1 | Employment Agreement, dated as of September 1, 2006, between the Company and David S. Doll.*(4) | |||
10.11.2 | Separation Agreement and General Release, dated July 30, 2008, between the Company and David S. Doll.*(4) | |||
10.11.3 | Consulting Agreement, effective as of September 4, 2008, between the Company and David S. Doll.*(4) | |||
10.12.1 | Offer of Employment Letter, effective as of March 31, 2008, between the Company and Michael Nestor.*(6) | |||
10.12.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Michael J. Nestor.*(10) | |||
10.13.1 | Offer of Employment Letter, effective as of January 5, 2009, between the Company and Christopher Mengler.*(6) | |||
10.13.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Christopher Mengler, R.Ph.*(10) | |||
10.14 | 2008 Cash Incentive Awards for Executive Officers.*(11) | |||
10.14.1 | Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.2 | Letter Amendment, dated October 8, 2003, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.3 | Letter Agreement, dated March 24, 2005, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.4 | 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.**(12) | |||
10.14.5 | Amendment, dated January 24, 2006, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(13) | |||
10.14.6 | Amendment, dated February 9, 2007, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.15.1 | Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.**(12) | |||
10.15.2 | 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.(13) | |||
10.15.3 | 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.(13) | |||
10.16.1 | Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering-Plough Corporation.**(13) | |||
10.16.2 | 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-Plough Corporation.**(12) |
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Exhibit No. | Description of Document | |||
10.16.3 | 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-Plough Corporation.**(12) | |||
10.17.1 | Supply and Distribution Agreement, dated as of November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(12) | |||
10.17.2 | Amendment No. 2, dated February 6, 2007, to Supply and Distribution Agreement, dated November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(13) | |||
10.18 | 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.(14) | |||
10.19 | 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.(14) | |||
10.20 | Sublicense Agreement, effective as of March 30, 2007, between the Company and DAVA Pharmaceuticals, Inc.(14) | |||
10.21 | Promotional Services Agreement, dated as of January 19, 2006, between the Company and Shire US Inc.(3) | |||
10.22 | License and Distribution Agreement, dated as of January 19, 2006, between the Company and Shire LLC.*** | |||
10.23 | Co-promotion Agreement, dated as of July 16, 2008, between the Company and Wyeth, acting through its Wyeth Pharmaceuticals Division.**(9) | |||
10.24 | Joint Development Agreement, dated as of November 26, 2008, between the Company and Medicis Pharmaceutical Corporation.**** | |||
10.25 | 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).(6) | |||
10.26 | 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).(6) | |||
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 on Form 10-K). | |||
21.1 | Subsidiaries of the registrant. | |||
23.1 | Consent of Grant Thornton LLP | |||
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 Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
32.2 | Certifications of the 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 granted for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
*** | Confidential treatment requested for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
**** | The Company is re-filing the Joint Development Agreement, dated as of November 26, 2008 (the “Joint Development Agreement”), with Medicis Pharmaceutical Corporation to disclose a milestone payment that was previously omitted in accordance with an order granting confidential treatment pursuant to Rule 24b-2 under the Exchange Act. Certain portions of the Joint Development Agreement remain confidential pursuant to an order granting confidential treatment under the Exchange Act, which portions are omitted and filed separately with the SEC. |
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(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 Current Report on Form 8-K filed on January 22, 2009. | |
(3) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 2, 2009. | |
(4) | Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008. | |
(5) | Incorporated by reference to Amendment No. 2 to the Company’s Registration Statement on Form 10 filed on December 2, 2008. | |
(6) | Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2008. | |
(7) | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2009. | |
(8) | Incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed on April 8, 2009. | |
(9) | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009. | |
(10) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010. | |
(11) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on March 5, 2009. | |
(12) | Incorporated by reference to Amendment No. 6 to the Company’s Registration Statement on Form 10 filed on January 14, 2009. | |
(13) | Incorporated by reference to Amendment No. 1 to the Company’s Registration Statement on Form 10 filed on November 12, 2008. | |
(14) | Incorporated by reference to Amendment No. 7 to the Company’s Registration Statement on Form 10 filed on January 21, 2009. |
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F-2 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7 | ||||
F-9 | ||||
S-1 |
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Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
Impax Laboratories, Inc.
We have audited the accompanying consolidated balance sheets of Impax Laboratories, Inc. and Subsidiaries (a Delaware corporation) (the “Company”) as of December 31, 2009 and 2008 and the related consolidated statements of operations, changes in stockholders’ equity (deficit), comprehensive income and cash flows for each of the three years in the period ended December 31, 2009. Our audits of the basic consolidated financial statements included the financial statement schedule, listed in the index appearing under Item 15. These financial statements and financial statement schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements and financial statement schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Impax Laboratories, Inc. and Subsidiaries as of December 31, 2009 and 2008, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2009 in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.
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Table of Contents
As discussed in Note 2 to the consolidated financial statements, the Company has adopted the provisions of accounting for convertible debt instruments which may be settled in cash or common stock upon conversion.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2009, based on criteria established inInternal Control-Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and our report dated February 26, 2010 expressed an unqualified opinion.
/s/ GRANT THORNTON LLP
Philadelphia, Pennsylvania
February 26, 2010
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(in thousands, except share and per share data)
December 31, | December 31, | |||||||
2009 | 2008 | |||||||
(as adjusted) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 31,770 | $ | 69,275 | ||||
Short-term investments | 58,599 | 50,710 | ||||||
Accounts receivable, net | 185,854 | 43,306 | ||||||
Inventory, net | 49,130 | 32,305 | ||||||
Current portion of deferred product manufacturing costs-alliance agreements | 11,624 | 13,578 | ||||||
Current portion of deferred income taxes, net | 32,286 | 17,900 | ||||||
Prepaid expenses and other current assets | 4,748 | 9,298 | ||||||
Total current assets | 374,011 | 236,372 | ||||||
Property, plant and equipment, net | 101,650 | 95,629 | ||||||
Deferred product manufacturing costs-alliance agreements | 96,619 | 93,144 | ||||||
Deferred income taxes, net | 48,544 | 52,551 | ||||||
Other assets | 12,358 | 9,017 | ||||||
Goodwill | 27,574 | 27,574 | ||||||
Total assets | $ | 660,756 | $ | 514,287 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt, net | $ | — | $ | 14,416 | ||||
Accounts payable | 23,295 | 12,797 | ||||||
Accrued expenses | 93,682 | 41,108 | ||||||
Accrued profit sharing and royalty expenses | 53,695 | 252 | ||||||
Current portion of deferred revenue-alliance agreements | 33,196 | 35,015 | ||||||
Current portion of accrued exclusivity period fee payments due | — | 6,000 | ||||||
Total current liabilities | 203,868 | 109,588 | ||||||
Long-term debt | — | 5,990 | ||||||
Deferred revenue-alliance agreements | 224,522 | 225,804 | ||||||
Other liabilities | 10,139 | 13,255 | ||||||
Total liabilities | $ | 438,529 | $ | 354,637 | ||||
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, 2009 and 2008 | $ | — | $ | — | ||||
Common stock, $0.01 par value, 90,000,000 shares authorized and 62,210,089 and 60,135,686 shares issued at December 31, 2009 and 2008, respectively | 622 | 602 | ||||||
Additional paid-in capital | 223,239 | 211,128 | ||||||
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 | (524 | ) | (995 | ) | ||||
Retained earnings (Accumulated deficit) | 828 | (49,233 | ) | |||||
222,008 | 159,345 | |||||||
Noncontrolling interest | 219 | 305 | ||||||
Total stockholders’ equity | 222,227 | 159,650 | ||||||
Total liabilities and stockholders’ equity | $ | 660,756 | $ | 514,287 | ||||
F-4
Table of Contents
(amounts in thousands, except share and per share data)
Years Ended December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
(as adjusted) | (as adjusted) | |||||||||||
Revenues: | ||||||||||||
Global product sales, net | $ | 287,079 | $ | 96,006 | $ | 85,037 | ||||||
Private Label product sales | 5,513 | 2,596 | 2,941 | |||||||||
Rx Partner | 33,835 | 81,778 | 161,114 | |||||||||
OTC Partner | 6,842 | 15,946 | 11,866 | |||||||||
Research Partner | 11,680 | 833 | — | |||||||||
Promotional Partner | 13,448 | 12,891 | 12,759 | |||||||||
Other | 12 | 21 | 36 | |||||||||
Total revenues | 358,409 | 210,071 | 273,753 | |||||||||
Cost of revenues | 170,313 | 91,969 | 107,656 | |||||||||
Gross profit | 188,096 | 118,102 | 166,097 | |||||||||
Operating expenses: | ||||||||||||
Research and development | 63,274 | 59,237 | 39,992 | |||||||||
Patent litigation | 5,379 | 6,472 | 10,025 | |||||||||
Litigation settlement | 9,318 | — | — | |||||||||
Selling, general and administrative | 39,712 | 48,470 | 39,573 | |||||||||
Total operating expenses | 117,683 | 114,179 | 89,590 | |||||||||
Income from operations | 70,413 | 3,923 | 76,507 | |||||||||
Change in fair value of common stock purchase warrants | — | 1,234 | (110 | ) | ||||||||
Loss on repurchase of 3.5% Debentures | — | (113 | ) | — | ||||||||
Other income, net | 57 | 21,529 | 11 | |||||||||
Interest income | 753 | 4,218 | 4,751 | |||||||||
Interest expense | (246 | ) | (4,782 | ) | (7,162 | ) | ||||||
Income before income taxes | 70,977 | 26,009 | 73,997 | |||||||||
Provision (benefit) for income taxes | 21,006 | 10,069 | (51,351 | ) | ||||||||
Net income before noncontrolling interest | 49,971 | 15,940 | 125,348 | |||||||||
Add back loss attributable to noncontrolling interest | 90 | 47 | 62 | |||||||||
Net income | $ | 50,061 | $ | 15,987 | $ | 125,410 | ||||||
Net Income per share: | ||||||||||||
Basic | $ | 0.83 | $ | 0.27 | $ | 2.13 | ||||||
Diluted | $ | 0.82 | $ | 0.26 | $ | 2.05 | ||||||
Weighted average common shares outstanding: | ||||||||||||
Basic | 60,279,602 | 59,072,752 | 58,810,452 | |||||||||
Diluted | 61,080,184 | 60,782,721 | 61,217,470 | |||||||||
F-5
Table of Contents
Retained | Accumulated | |||||||||||||||||||||||||||
Additional | Earnings/ | Other | ||||||||||||||||||||||||||
Common Stock | Paid-In | Treasury | (Accumulated | Comprehensive | ||||||||||||||||||||||||
Stockholders’ Equity (Deficit) | Shares | Par Value | Capital | Stock | Deficit) | Loss | Total | |||||||||||||||||||||
Balance at December 31, 2006 | 58,785 | $ | 590 | $ | 183,809 | $ | (2,157 | ) | $ | (186,215 | ) | $ | (3 | ) | $ | (3,976 | ) | |||||||||||
2007 | ||||||||||||||||||||||||||||
Adoption of FASB ASC Topic 470 accounting for convertible debt | 6,666 | (4,415 | ) | 2,251 | ||||||||||||||||||||||||
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 | 125,410 | 125,410 | ||||||||||||||||||||||||||
Balance at December 31, 2007 | 58,822 | $ | 591 | $ | 202,715 | $ | (2,157 | ) | $ | (65,220 | ) | $ | (26 | ) | $ | 135,903 | ||||||||||||
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 | ||||||||||||||||||||||||
Reversal of deferred tax liability on 3.5% Debenture conversion option as a result of repurchase | 924 | 924 | ||||||||||||||||||||||||||
Currency translation adjustments | (969 | ) | (969 | ) | ||||||||||||||||||||||||
Net income | 15,987 | 15,987 | ||||||||||||||||||||||||||
Balance at December 31, 2008 | 59,892 | $ | 602 | $ | 211,128 | $ | (2,157 | ) | $ | (49,233 | ) | $ | (995 | ) | $ | 159,345 | ||||||||||||
2009 | ||||||||||||||||||||||||||||
Exercise of stock options issuance of restricted stock and sale of common stock under ESPP | 2,074 | 20 | 4,507 | 4,527 | ||||||||||||||||||||||||
Share-based compensation expense | 7,391 | 7,391 | ||||||||||||||||||||||||||
Tax benefit related to exercise of employee stock options | 213 | 213 | ||||||||||||||||||||||||||
Currency translation adjustments | 471 | 471 | ||||||||||||||||||||||||||
Net income | 50,061 | 50,061 | ||||||||||||||||||||||||||
Balance at December 31, 2009 | 61,966 | $ | 622 | $ | 223,239 | $ | (2,157 | ) | $ | 828 | $ | (524 | ) | $ | 222,008 | |||||||||||||
Years Ended December 31, | ||||||||||||
Comprehensive Income | 2009 | 2008 | 2007 | |||||||||
Net income | $ | 50,061 | $ | 15,987 | $ | 125,410 | ||||||
Currency translation adjustments | 471 | (969 | ) | (23 | ) | |||||||
Comprehensive income | $ | 50,532 | $ | 15,018 | $ | 125,387 | ||||||
F-6
Table of Contents
Years Ended December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
(as adjusted) | (as adjusted) | |||||||||||
Cash flows from operating activities: | ||||||||||||
Net income | $ | 50,061 | $ | 15,987 | $ | 125,410 | ||||||
Adjustments to reconcile net income to net cash (used in) provided by operating activities: | ||||||||||||
Depreciation | 11,266 | 9,588 | 8,144 | |||||||||
Amortization of 3.5% Debentures discount and deferred financing costs | 307 | 2,416 | 3,368 | |||||||||
Amortization of Wachovia Credit Agreement deferred financing costs | 75 | 74 | 148 | |||||||||
Bad debt expense | 229 | 568 | 550 | |||||||||
Deferred income taxes (benefit) | (10,379 | ) | 3,816 | 16,427 | ||||||||
Tax benefit on reversal of valuation allowance on deferred tax asset | — | — | (82,963 | ) | ||||||||
Tax benefit related to the exercise of employee stock options | (213 | ) | — | (10,477 | ) | |||||||
Change in accrual for uncertain tax positions | (6,308 | ) | 1,397 | 6,118 | ||||||||
Loss, net on repurchase of 3.5% Debentures | — | 113 | — | |||||||||
Deferred revenue – Rx Partners | 35,295 | 94,876 | 234,816 | |||||||||
Deferred product manufacturing costs – Rx Partners | (24,089 | ) | (33,928 | ) | (64,681 | ) | ||||||
Deferred revenue recognized – Rx Partners | (33,835 | ) | (81,778 | ) | (161,114 | ) | ||||||
Amortization deferred product manufacturing costs – Rx Partners | 18,410 | 22,713 | 46,363 | |||||||||
Deferred revenue – OTC Partners | 1,960 | 16,399 | 15,359 | |||||||||
Deferred product manufacturing costs – OTC Partners | (1,929 | ) | (16,087 | ) | (13,014 | ) | ||||||
Deferred revenue recognized – OTC Partners | (6,842 | ) | (15,946 | ) | (11,866 | ) | ||||||
Amortization deferred product manufacturing costs – OTC Partners | 6,087 | 14,977 | 9,900 | |||||||||
Deferred revenue – Research Partners | 12,000 | 40,000 | — | |||||||||
Deferred revenue recognized – Research Partners | (11,680 | ) | (833 | ) | — | |||||||
Accrued profit sharing and royalty expense | 53,912 | 360 | 921 | |||||||||
Profit sharing and royalty payments | (469 | ) | (656 | ) | (944 | ) | ||||||
Payments on exclusivity period fee | (6,000 | ) | (12,000 | ) | (18,200 | ) | ||||||
Accrued litigation settlement expense | 5,865 | 3,500 | — | |||||||||
Payments on accrued litigation settlements | (11,495 | ) | (2,197 | ) | (2,573 | ) | ||||||
Share-based compensation expense | 7,391 | 5,817 | 1,514 | |||||||||
Fair value of shares issued under severance arrangement | — | 561 | — | |||||||||
Accretion of interest income on short-term investments | (519 | ) | (2,867 | ) | (3,147 | ) | ||||||
Change in fair value of stock purchase warrants | — | (1,234 | ) | 110 | ||||||||
Changes in assets and liabilities: | ||||||||||||
Accounts receivable | (142,777 | ) | 7,629 | 9,868 | ||||||||
Inventory | (16,825 | ) | (4,737 | ) | 6,543 | |||||||
Prepaid expenses and other assets | 2,179 | (4,184 | ) | (6,324 | ) | |||||||
Accounts payable and accrued expenses | 57,059 | (517 | ) | 7,569 | ||||||||
Other liabilities | 3,107 | 737 | 1,189 | |||||||||
Net cash (used in) provided by operating activities | $ | (8,157 | ) | $ | 64,564 | $ | 119,014 | |||||
Cash flows from investing activities: | ||||||||||||
Purchase of short-term investments | (66,626 | ) | (202,133 | ) | (244,119 | ) | ||||||
Maturities of short-term investments | 59,256 | 260,324 | 164,667 | |||||||||
Acquisition of ANDA intellectual property rights | (750 | ) | — | — | ||||||||
Purchases of property, plant and equipment | (13,667 | ) | (25,863 | ) | (18,836 | ) | ||||||
Net cash (used in) provided by investing activities | $ | (21,787 | ) | $ | 32,328 | $ | (98,288 | ) | ||||
F-7
Table of Contents
CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)
(dollars in thousands)
Years Ended December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
(as adjusted) | (as adjusted) | |||||||||||
Cash flows from financing activities: | ||||||||||||
Repayment of long-term debt | (12,887 | ) | (65,234 | ) | (253 | ) | ||||||
Tax benefit related to the exercise of employee stock options | 213 | — | 10,477 | |||||||||
Proceeds from exercise of stock options and purchases under the ESPP | 5,113 | 155 | 113 | |||||||||
Net cash (used in) provided by financing activities | $ | (7,561 | ) | $ | (65,079 | ) | $ | 10,337 | ||||
Net (decrease) increase in cash and cash equivalents | $ | (37,505 | ) | $ | 31,813 | $ | 31,063 | |||||
Cash and cash equivalents, beginning of period | $ | 69,275 | $ | 37,462 | $ | 6,399 | ||||||
Cash and cash equivalents, end of period | $ | 31,770 | $ | 69,275 | $ | 37,462 | ||||||
Years Ended December 31, | ||||||||||||
(in $000s) | 2009 | 2008 | 2007 | |||||||||
(as adjusted) | (as adjusted) | |||||||||||
Cash paid for interest | $ | 622 | $ | 2,970 | $ | 4,556 | ||||||
Cash paid for income taxes | $ | 415 | $ | 8,381 | $ | 14,106 | ||||||
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F-9
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F-10
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Percent of Total Accounts Receivable | 2009 | 2008 | 2007 | |||||||||
Customer #1 | 19.9 | % | 22.9 | % | 8.7 | % | ||||||
Customer #2 | 18.7 | % | 20.4 | % | 19.1 | % | ||||||
Customer #3 | 43.8 | % | 20.4 | % | 15.8 | % | ||||||
Customer #4 | — | % | 13.5 | % | 26.1 | % | ||||||
Customer #5 | — | % | 6.0 | % | — | % | ||||||
Customer #6 | — | % | — | % | 8.4 | % | ||||||
Customer #7 | 3.6 | % | — | % | — | % | ||||||
Customer #8 | 2.7 | % | — | % | — | % | ||||||
Total-Five largest customers | 88.7 | % | 83.2 | % | 78.1 | % | ||||||
Percent of Gross Revenues | 2009 | 2008 | 2007 | |||||||||
Customer #1 | 22.2 | % | 18.0 | % | 13.2 | % | ||||||
Customer #2 | 5.7 | % | 14.0 | % | 12.7 | % | ||||||
Customer #3 | — | % | 13.9 | % | 35.5 | % | ||||||
Customer #4 | 26.5 | % | 11.6 | % | 10.3 | % | ||||||
Customer #5 | 15.3 | % | 10.9 | % | 5.5 | % | ||||||
Customer #6 | 3.9 | % | — | % | — | % | ||||||
Total-Five largest customers | 73.6 | % | 68.4 | % | 77.2 | % | ||||||
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F-12
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Twelve Months Ended: | ||||||||||||
December 31, | December 31, | December 31, | ||||||||||
(in $000’s except per share amounts) | 2009 | 2008 | 2007 | |||||||||
Additional interest expense | $ | 253 | $ | 2,183 | $ | 3,048 | ||||||
Reduction in gain on extinguishment of debt | — | (1,432 | ) | — | ||||||||
Benefit for income taxes | (89 | ) | (902 | ) | (2,533 | ) | ||||||
Decrease in net income | $ | (164 | ) | $ | (2,713 | ) | $ | (515 | ) | |||
Decrease in Net income per share: | ||||||||||||
Basic | $ | — | $ | (0.05 | ) | $ | (0.01 | ) | ||||
Diluted | $ | — | $ | (0.04 | ) | $ | (0.01 | ) |
F-13
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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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F-17
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F-19
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F-22
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Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2009 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper | $ | 13,387 | $ | 4 | $ | (1 | ) | $ | 13,390 | |||||||
Government sponsored enterprise obligations | 41,953 | 32 | (1 | ) | 41,984 | |||||||||||
Corporate bonds | 3,021 | 1 | (1 | ) | 3,021 | |||||||||||
Asset-backed securities | — | — | — | — | ||||||||||||
Certificates of deposit | 238 | — | — | 238 | ||||||||||||
Total short-term investments | $ | 58,599 | $ | 37 | $ | (3 | ) | $ | 58,633 | |||||||
Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2008 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper | $ | 6,194 | $ | — | $ | — | $ | 6,194 | ||||||||
Government sponsored enterprise 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 | |||||||
F-23
Table of Contents
December 31, | December 31, | |||||||
(in $000’s) | 2009 | 2008 | ||||||
Gross accounts receivable | $ | 254,094 | $ | 54,591 | ||||
Less: Rebate reserve | (37,781 | ) | (4,800 | ) | ||||
Less: Chargeback reserve | (21,448 | ) | (4,056 | ) | ||||
Less: Other deductions | (9,011 | ) | (2,429 | ) | ||||
Accounts receivable, net | $ | 185,854 | $ | 43,306 | ||||
(in $000’s) | December 31, | December 31, | December 31, | |||||||||
Rebate reserve | 2009 | 2008 | 2007 | |||||||||
Beginning balance | $ | 4,800 | $ | 3,603 | $ | 3,124 | ||||||
Provision recorded during the period | 72,620 | 20,361 | 15,968 | |||||||||
Credits issued during the period | (39,639 | ) | (19,164 | ) | (15,489 | ) | ||||||
Ending balance | $ | 37,781 | $ | 4,800 | $ | 3,603 | ||||||
(in $000’s) | December 31, | December 31, | December 31, | |||||||||
Chargeback reserve | 2009 | 2008 | 2007 | |||||||||
Beginning balance | $ | 4,056 | $ | 2,977 | $ | 4,401 | ||||||
Provision recorded during the period | 126,105 | 50,144 | 33,972 | |||||||||
Credits issued during the period | (108,713 | ) | (49,065 | ) | (35,396 | ) | ||||||
Ending balance | $ | 21,448 | $ | 4,056 | $ | 2,977 | ||||||
F-24
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December 31, | December 31, | |||||||
(in $000’s) | 2009 | 2008 | ||||||
Raw materials | $ | 30,758 | $ | 16,940 | ||||
Work in process | 2,768 | 1,397 | ||||||
Finished goods | 17,051 | 16,504 | ||||||
Total inventory, net | $ | 50,577 | $ | 34,841 | ||||
Less: Non-current inventory, net | (1,447 | ) | (2,536 | ) | ||||
Total inventory-current, net | $ | 49,130 | $ | 32,305 | ||||
F-25
Table of Contents
December 31, | December 31, | |||||||
(in $000’s) | 2009 | 2008 | ||||||
Land | $ | 2,270 | $ | 2,270 | ||||
Buildings and improvements | 77,778 | 55,310 | ||||||
Equipment | 59,612 | 49,983 | ||||||
Office furniture and equipment | 7,425 | 6,733 | ||||||
Construction-in-progress | 4,880 | 21,019 | ||||||
Property, plant and equipment, gross | $ | 151,965 | $ | 135,315 | ||||
Less: Accumulated depreciation | (50,315 | ) | (39,686 | ) | ||||
Property, plant and equipment, net | $ | 101,650 | $ | 95,629 | ||||
F-26
Table of Contents
December 31, | December 31, | |||||||
(in $000’s) | 2009 | 2008 | ||||||
Payroll-related expenses | $ | 15,274 | $ | 15,147 | ||||
Product returns | 22,114 | 13,675 | ||||||
Income taxes payable | 31,627 | — | ||||||
Shelf stock price protection | 225 | 572 | ||||||
Medicaid rebates | 9,759 | 584 | ||||||
Physician detailing sales force fees | 2,449 | 2,279 | ||||||
Legal and professional fees | 3,660 | 2,087 | ||||||
Litigation settlements | 5,865 | 4,526 | ||||||
Other | 2,709 | 2,238 | ||||||
Total accrued expenses | $ | 93,682 | $ | 41,108 | ||||
(in $000’s) | December 31, | December 31, | December 31, | |||||||||
Returns Reserve | 2009 | 2008 | 2007 | |||||||||
(in $000’s) | ||||||||||||
Beginning balance | $ | 13,675 | $ | 14,261 | $ | 12,903 | ||||||
Provision related to sales recorded in the period | 11,847 | 5,719 | 5,459 | |||||||||
Credits issued during the period | (3,408 | ) | (6,305 | ) | (4,101 | ) | ||||||
Ending balance | $ | 22,114 | $ | 13,675 | $ | 14,261 | ||||||
F-27
Table of Contents
Common | Common | |||||||||||
Stock | Stock | Total | ||||||||||
Purchase | Purchase | Reported | ||||||||||
Warrants | Warrants | Liability | ||||||||||
Outstanding | Value | Value | ||||||||||
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 | — | $ | — | $ | — | |||||||
Warrants exercised in 2009 | — | |||||||||||
Ending balance December 31, 2009 | — | $ | — | $ | — | |||||||
For the Years Ended December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
Volatility (range) | — | 43.0 - 49.0 | % | 24.2 - 46.4 | % | |||||||
Risk-free interest rate (range) | — | 1.25 - 1.50 | % | 3.4 - 4.9 | % | |||||||
Dividend yield | — | 0 | % | 0 | % |
F-28
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For the Years Ended December 31, | ||||||||||||
(in $000’s) | 2009 | 2008 | 2007 | |||||||||
Current: | ||||||||||||
Federal taxes | $ | 29,550 | $ | 6,315 | $ | 8,282 | ||||||
State taxes | 1,715 | (62 | ) | 6,903 | ||||||||
Total current tax expense | 31,265 | 6,253 | 15,185 | |||||||||
Deferred: | ||||||||||||
Federal taxes | $ | (11,520 | ) | $ | 4,938 | $ | 14,285 | |||||
Federal taxes-change in valuation allowance | — | — | (64,771 | ) | ||||||||
State taxes | 1,995 | (1,122 | ) | (2,303 | ) | |||||||
State taxes-change in valuation allowance | — | — | (13,747 | ) | ||||||||
Foreign taxes | (734 | ) | — | — | ||||||||
Total deferred tax expense (benefit) | (10,259 | ) | 3,816 | (66,536 | ) | |||||||
Provision for (benefit from) income taxes | $ | 21,006 | $ | 10,069 | $ | (51,351 | ) | |||||
For the Years Ended December 31, | ||||||||||||||||||||||||
(in $000’s) | 2009 | 2008 | 2007 | |||||||||||||||||||||
Income before income taxes | $ | 70,977 | $ | 26,009 | $ | 73,997 | ||||||||||||||||||
Tax provision at federal statutory rate | 24,842 | 35.0 | % | 9,103 | 35.0 | % | 25,899 | 35.0 | % | |||||||||||||||
Increase (decrease) in tax rate resulting from: | ||||||||||||||||||||||||
State and local taxes, net of federal benefit | 3,628 | 5.1 | % | 25 | 0.1 | % | 2,647 | 3.6 | % | |||||||||||||||
Increase in federal statutory tax rate on deferred tax accounts | — | — | — | — | (1,993 | ) | (2.7 | )% | ||||||||||||||||
Research and development credits | (2,546 | ) | (3.6 | )% | (2,228 | ) | (8.6 | )% | (1,306 | ) | (1.8 | )% | ||||||||||||
Share-based compensation | 1,824 | 2.6 | % | 1,438 | 5.5 | % | 528 | 0.7 | % | |||||||||||||||
Domestic manufacturing deduction | (700 | ) | (1.0 | )% | (531 | ) | (2.0 | )% | (676 | ) | (0.9 | )% | ||||||||||||
Change in warrant fair value | — | — | % | (432 | ) | (1.6 | )% | 38 | — | % | ||||||||||||||
Provision for uncertain tax positions | (6,084 | ) | (8.6 | )% | 1,050 | 4.0 | % | 6,118 | 8.3 | % | ||||||||||||||
Other, net | 294 | 0.4 | % | 1,311 | 4.9 | % | (4,087 | ) | (5.5 | )% | ||||||||||||||
Change in valuation allowance | (252 | ) | (0.3 | )% | 333 | 1.4 | % | (78,518 | ) | (106.1 | )% | |||||||||||||
Provision for (benefit from) income taxes | $ | 21,006 | 29.6 | % | $ | 10,069 | 38.7 | % | $ | (51,351 | ) | (69.4 | )% | |||||||||||
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December 31, | ||||||||
(in $000’s) | 2009 | 2008 | ||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 1,648 | $ | 831 | ||||
Research and development credits | 620 | 3,009 | ||||||
Inventory reserves | 2,936 | 2,490 | ||||||
Accrued expenses | 21,115 | 11,711 | ||||||
Deferred revenues | 100,009 | 87,789 | ||||||
Accrued exclusivity period fee payments | — | 3,073 | ||||||
Litigation settlements | — | 2,376 | ||||||
Depreciation and amortization | 492 | 371 | ||||||
Other | 3,054 | 4,693 | ||||||
Gross deferred tax assets | $ | 129,874 | $ | 116,343 | ||||
Deferred tax liabilities: | ||||||||
Tax depreciation and amortization in excess of book amounts | $ | 3,919 | $ | 2,205 | ||||
Deferred manufacturing costs | 42,591 | 42,267 | ||||||
Deferred revenues | 849 | 854 | ||||||
Other | 1,685 | 566 | ||||||
Gross deferred tax liabilities | $ | 49,044 | $ | 45,892 | ||||
Deferred tax assets, net | $ | 80,830 | $ | 70,451 | ||||
December 31, | ||||||||
(in $000’s) | 2009 | 2008 | ||||||
Current deferred tax assets | $ | 38,837 | $ | 23,940 | ||||
Current deferred tax liabilities | (6,551 | ) | (6,040 | ) | ||||
Current deferred tax assets, net | 32,286 | 17,900 | ||||||
Non-current deferred tax assets | 91,037 | 92,881 | ||||||
Non-current deferred tax liabilities | (42,493 | ) | (40,330 | ) | ||||
Non-current deferred tax assets, net | 48,544 | 52,551 | ||||||
Deferred tax assets | $ | 80,830 | $ | 70,451 | ||||
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(in $000’s) | ||||
Year | Amount | |||
2020 | $ | 1,530 | ||
2021 | 4,969 | |||
2022 | 1,955 | |||
2023 | 3,775 | |||
Total | $ | 12,229 | ||
(in $000’s) | ||||
Balance at January 1, 2009 | $ | 7,515 | ||
Increase/(decrease) based on prior year tax positions | (6,482 | ) | ||
Increase/(decrease) based on current year tax positions | 174 | |||
Balance at December 31, 2009 | $ | 1,207 | ||
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Year Ended December 31: | ||||||||||||
(in $000’s) | 2009 | 2008 | 2007 | |||||||||
Contractual interest | $ | 202 | $ | 2,084 | $ | 3,089 | ||||||
Discount amortization | 241 | 2,078 | 2,904 | |||||||||
Deferred financing cost amortization | 66 | 338 | 464 | |||||||||
Total interest cost | $ | 509 | $ | 4,500 | $ | 6,457 | ||||||
Effective interest rate on 3.5% Debentures | 8.7 | % | 8.7 | % | 8.6 | % | ||||||
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December 31, | December 31, | |||||||
(in $000’s) | 2009 | 2008 | ||||||
3.5% Debentures face value | $ | — | $ | 12,750 | ||||
Unamortized discount | — | (241 | ) | |||||
3.5% Debentures net carrying amount | — | 12,509 | ||||||
Subordinated promissory note — (1) | — | 7,760 | ||||||
Vendor financing agreement (2) | — | 137 | ||||||
Total Debt | $ | — | $ | 20,406 | ||||
Less: Current portion | — | (14,416 | ) | |||||
Long-term portion | $ | — | $ | 5,990 | ||||
(1) | In August 2009, the Company repaid-in-full the remaining outstanding balance of a subordinated promissory note, paying $6,888,000 of principal and $51,000 of accrued interest expense. Initially, the subordinated promissory note was issued in June 2006 in the amount of $11.0 million, with an interest rate of 6.0% per annum, and 24 quarterly installment payments of $549,165, commencing in March 2007. | |
(2) | Vendor financing agreement at 3.10% payable in two monthly installments of $0 and 34 monthly installments of $12,871 commencing December 2006 and ending in November 2009. |
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• | 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 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. |
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• | 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 | ||||||||||||||||
(in $000’s) | For the Years Ended December 31, | Through | ||||||||||||||
Deferred revenue | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | 200,608 | $ | 181,149 | $ | 136,157 | $ | — | ||||||||
Additions: | ||||||||||||||||
Cost sharing | 700 | 700 | 732 | 4,521 | ||||||||||||
Product related deferrals | 34,545 | 59,706 | 133,873 | 182,492 | ||||||||||||
Subtotal | 35,245 | 60,406 | 134,605 | 187,013 | ||||||||||||
Exclusivity charges | — | — | (47,133 | ) | (3,467 | ) | ||||||||||
Forgiveness of advance deposit | — | — | — | 6,000 | ||||||||||||
Forgiveness of interest | — | — | — | 4,370 | ||||||||||||
Stock repurchase | — | — | — | 2,157 | ||||||||||||
Total additions | $ | 35,245 | $ | 60,406 | $ | 87,472 | $ | 196,073 | ||||||||
Less: amounts recognized: | ||||||||||||||||
Forgiveness of advance deposit | $ | (303 | ) | $ | (333 | ) | $ | (333 | ) | $ | (1,833 | ) | ||||
Forgiveness of interest | (222 | ) | (243 | ) | (243 | ) | (1,337 | ) | ||||||||
Stock repurchase | (109 | ) | (120 | ) | (120 | ) | (659 | ) | ||||||||
Cost sharing | (611 | ) | (583 | ) | (516 | ) | (1,382 | ) | ||||||||
Product related revenue | (32,576 | ) | (39,668 | ) | (41,268 | ) | (54,705 | ) | ||||||||
Total amount recognized | (33,821 | ) | (40,947 | ) | (42,480 | ) | (59,916 | ) | ||||||||
Total deferred revenue | $ | 202,032 | $ | 200,608 | $ | 181,149 | $ | 136,157 | ||||||||
(in $000’s) | Inception | |||||||||||||||
Deferred product | For the Years Ended December 31, | Through | ||||||||||||||
manufacturing costs | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | 88,361 | $ | 75,296 | $ | 49,728 | $ | — | ||||||||
Additions | 24,089 | 33,621 | 46,246 | 71,609 | ||||||||||||
Less amounts amortized | (18,410 | ) | (20,556 | ) | (20,678 | ) | (21,881 | ) | ||||||||
Total deferred product manufacturing costs | $ | 94,040 | $ | 88,361 | $ | 75,296 | $ | 49,728 | ||||||||
Deferred | ||||||||
Deferred | Product | |||||||
Revenue | Manufacturing Costs | |||||||
(in $000s) | Recognition | Amortization | ||||||
2010 | $ | 13,625 | $ | 6,340 | ||||
2011 | 13,625 | 6,340 | ||||||
2012 | 13,625 | 6,340 | ||||||
2013 | 13,625 | 6,340 | ||||||
2014 | 13,625 | 6,340 | ||||||
Thereafter | 133,907 | 62,340 | ||||||
Totals | $ | 202,032 | $ | 94,040 | ||||
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Inception | ||||||||||||||||
(in $000’s) | For the Years Ended December 31, | Through | ||||||||||||||
Deferred revenue | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | 21,044 | $ | 20,591 | $ | 17,098 | $ | — | ||||||||
Additions: | ||||||||||||||||
Upfront fees and milestone payments | — | — | 84 | 8,352 | ||||||||||||
Cost sharing and other | — | — | 424 | 1,218 | ||||||||||||
Product related deferrals | 1,960 | 16,399 | 14,851 | 50,616 | ||||||||||||
Total additions | $ | 1,960 | $ | 16,399 | $ | 15,359 | $ | 60,186 | ||||||||
Less: amounts recognized: | ||||||||||||||||
Upfront fees and milestone payments | (276 | ) | (297 | ) | (315 | ) | (6,857 | ) | ||||||||
Cost sharing and other | (112 | ) | (112 | ) | (312 | ) | (1,014 | ) | ||||||||
Product related revenue | (6,454 | ) | (15,537 | ) | (11,239 | ) | (35,217 | ) | ||||||||
Total amount recognized | (6,842 | ) | (15,946 | ) | (11,866 | ) | (43,088 | ) | ||||||||
Total deferred revenue | $ | 16,162 | $ | 21,044 | $ | 20,591 | $ | 17,098 | ||||||||
(in $000’s) | Inception | |||||||||||||||
Deferred product | For the Years Ended December 31, | Through | ||||||||||||||
manufacturing costs | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | 18,361 | $ | 17,251 | $ | 14,137 | $ | — | ||||||||
Additions: | ||||||||||||||||
Product related deferrals | 1,897 | 16,037 | 12,172 | 41,708 | ||||||||||||
Cost sharing and other | 32 | 50 | 842 | 5,132 | ||||||||||||
Total additions | $ | 1,929 | $ | 16,087 | $ | 13,014 | $ | 46,840 | ||||||||
Less: amount amortized: | ||||||||||||||||
Product related cost | (5,774 | ) | (14,634 | ) | (9,201 | ) | (29,284 | ) | ||||||||
Cost sharing and other | (313 | ) | (343 | ) | (699 | ) | (3,419 | ) | ||||||||
Total amount amortized | (6,087 | ) | (14,977 | ) | (9,900 | ) | (32,703 | ) | ||||||||
Total deferred product manufacturing costs | $ | 14,203 | $ | 18,361 | $ | 17,251 | $ | 14,137 | ||||||||
Deferred | ||||||||
Deferred | Product | |||||||
Revenue | Manufacturing Costs | |||||||
(in $000s) | Recognition | Amortization | ||||||
2010 | $ | 6,027 | $ | 5,285 | ||||
2011 | 2,072 | 1,825 | ||||||
2012 | 1,282 | 1,133 | ||||||
2013 | 1,282 | 1,133 | ||||||
2014 | 1,282 | 1,133 | ||||||
Thereafter | 4,217 | 3,694 | ||||||
Total | $ | 16,162 | $ | 14,203 | ||||
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Inception | ||||||||||||||||
(in $000’s) | For the Years Ended December 31, | Through | ||||||||||||||
Deferred revenue | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | — | $ | 6,361 | $ | 24,784 | $ | — | ||||||||
Additions: | ||||||||||||||||
Upfront fees and milestone payments | — | — | — | 10,000 | ||||||||||||
Product related deferrals | — | 34,470 | 100,211 | 17,766 | ||||||||||||
Total additions | — | 34,470 | 100,211 | 27,766 | ||||||||||||
Less: amounts recognized: | ||||||||||||||||
Upfront fees and milestone payments | — | (858 | ) | (7,975 | ) | (1,167 | ) | |||||||||
Product related revenue | — | (39,973 | ) | (110,659 | ) | (1,815 | ) | |||||||||
Total amount recognized | — | (40,831 | ) | (118,634 | ) | (2,982 | ) | |||||||||
Total deferred revenue | $ | — | $ | — | $ | 6,361 | $ | 24,784 | ||||||||
(in $000’s) | Inception | |||||||||||||||
Deferred product | For the Years Ended December 31, | Through | ||||||||||||||
manufacturing costs | 2009 | 2008 | 2007 | Dec 31, 2006 | ||||||||||||
Beginning balance | $ | — | $ | 1,850 | $ | 9,100 | $ | — | ||||||||
Additions | — | 307 | 18,435 | 10,302 | ||||||||||||
Less: amount recognized | — | (2,157 | ) | (25,685 | ) | (1,202 | ) | |||||||||
Total deferred product manufacturing costs | $ | — | $ | — | $ | 1,850 | $ | 9,100 | ||||||||
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(in $000’s) | Years Ended December 31, | |||||||
Deferred revenue | 2009 | 2008 | ||||||
Beginning balance | $ | 39,167 | $ | — | ||||
Additions: | ||||||||
Up-front fees and milestone payments | 12,000 | 40,000 | ||||||
Product related deferrals | — | — | ||||||
Total additions | 12,000 | 40,000 | ||||||
Less: amounts recognized: | ||||||||
Up-front fees and milestone payments | (11,680 | ) | (833 | ) | ||||
Product related revenue | — | — | ||||||
Total amount recognized | (11,680 | ) | (833 | ) | ||||
Total deferred revenue | $ | 39,487 | $ | 39,167 | ||||
Deferred | ||||
Revenue | ||||
(in $000s) | Recognition | |||
2010 | $ | 13,538 | ||
2011 | 13,538 | |||
2012 | 12,411 | |||
2013 | — | |||
2014 | — | |||
Thereafter | — | |||
Total | $ | 39,487 | ||
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Weighted | ||||||||
Average | ||||||||
Exercise | ||||||||
Number of Shares | Price | |||||||
Stock Options | Under Option | per Share | ||||||
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 | |||||
Options granted | 2,489,141 | $ | 6.96 | |||||
Options exercised | (1,175,897 | ) | $ | 3.69 | ||||
Options forfeited | (1,363,666 | ) | $ | 13.86 | ||||
Outstanding at December 31, 2009 | 8,229,818 | $ | 9.87 | |||||
Vested and expected to vest at December 31, 2009 | 8,199,272 | $ | 9.93 | |||||
Options exercisable at December 31, 2009 | 4,598,069 | $ | 11.33 | |||||
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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 | |||||
Granted | 886,969 | $ | 6.99 | |||||
Vested | (113,204 | ) | $ | 10.25 | ||||
Forfeited | (20,558 | ) | $ | 7.87 | ||||
Non-vested at December 31, 2009 | 1,152,923 | $ | 7.72 | |||||
For the Years Ended December 31, | ||||||||||||
2009 | 2008 | 2007 | ||||||||||
Volatility (range) | 58.3%-64.2 | % | 64.1%-67.7 | % | 67.7%-75.2 | % | ||||||
Volatility (weighted average) | 60.4 | % | 66.8 | % | 69.9 | % | ||||||
Risk-free interest rate (range) | 2.1%-2.9 | % | 1.6%-3.8 | % | 3.4%-5.0 | % | ||||||
Risk-free interest rate (weighted average) | 2.6 | % | 3.0 | % | 4.0 | % | ||||||
Dividend yield | 0 | % | 0 | % | 0 | % | ||||||
Expected life (years) | 6.25 | 6.25 | 6.07 | |||||||||
Weighted average grant date fair value per option | $ | 4.07 | $ | 5.58 | $ | 7.43 |
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For the Years Ended December 31, | ||||||||||||
(in $000’s) | 2009 | 2008 | 2007 | |||||||||
Cost of revenues | $ | 1,600 | $ | 1,538 | $ | 418 | ||||||
Research and development | 2,677 | 2,273 | 563 | |||||||||
Selling, general and administrative | 3,114 | 2,006 | 532 | |||||||||
Total | $ | 7,391 | $ | 5,817 | $ | 1,513 | ||||||
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For the Years Ended December 31, | ||||||||||||
(in $000’s, except share and per share amounts) | 2009 | 2008 | 2007 | |||||||||
Numerator: | ||||||||||||
Net income | $ | 50,061 | $ | 15,987 | $ | 125,410 | ||||||
Denominator: | ||||||||||||
Weighted average common shares outstanding | 60,279,602 | 59,072,752 | 58,810,452 | |||||||||
Effect of dilutive options and and common stock purchase warrants | 800,582 | 1,709,969 | 2,407,018 | |||||||||
Diluted weighted average common shares outstanding | 61,080,184 | 60,782,721 | 61,217,470 | |||||||||
Basic net income per share | $ | 0.83 | $ | 0.27 | $ | 2.13 | ||||||
Diluted net income per share | $ | 0.82 | $ | 0.26 | $ | 2.05 | ||||||
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(in $000’s) | Global | Impax | Corporate | Total | ||||||||||||
Year Ended December 31, 2009 | Division | Division | and Other | Company | ||||||||||||
Revenues, net | $ | 344,961 | $ | 13,448 | $ | — | $ | 358,409 | ||||||||
Cost of revenues | 158,270 | 12,043 | — | 170,313 | ||||||||||||
Research and development | 38,698 | 24,576 | — | 63,274 | ||||||||||||
Patent Litigation | 5,379 | — | — | 5,379 | ||||||||||||
Income (loss) before income taxes | $ | 131,723 | $ | (26,640 | ) | $ | (34,106 | ) | $ | 70,977 |
Global | Impax | Corporate | Total | |||||||||||||
Year Ended December 31, 2008 | Division | Division | and Other | Company | ||||||||||||
Revenues, net | $ | 197,180 | $ | 12,891 | $ | — | $ | 210,071 | ||||||||
Cost of revenues | 80,724 | 11,245 | — | 91,969 | ||||||||||||
Research and development | 42,930 | 16,307 | — | 59,237 | ||||||||||||
Patent Litigation | 6,472 | — | — | 6,472 | ||||||||||||
Income (loss) before income taxes | $ | 55,609 | $ | (17,332 | ) | $ | (12,268 | ) | $ | 26,009 |
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 | $ | 115,894 | $ | (8,586 | ) | $ | (33,311 | ) | $ | 73,997 |
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Years Ended | ||||
(in $000s) | December 31, | |||
2010 | $ | 1,275 | ||
2011 | 1,059 | |||
2012 | 1,014 | |||
2013 | 1,024 | |||
2014 | 819 | |||
Thereafter | 212 | |||
Total minimum lease payments | $ | 5,403 | ||
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2009 Quarters Ended: | ||||||||||||||||
(in $000’s except per share amounts) | March 31 | June 30 | September 30 | December 31 | ||||||||||||
Revenue: | ||||||||||||||||
Global product sales, gross | $ | 78,696 | $ | 81,764 | $ | 82,514 | $ | 281,540 | ||||||||
Less: | ||||||||||||||||
Chargebacks | 22,638 | 24,844 | 21,265 | 57,358 | ||||||||||||
Rebates | 10,819 | 13,425 | 9,411 | 38,965 | ||||||||||||
Returns | 3,256 | 3,100 | 2,030 | 3,461 | ||||||||||||
Other credits | 2,862 | 3,008 | 3,172 | 17,821 | ||||||||||||
Global product sales, net | 39,121 | 37,387 | 46,636 | 163,935 | ||||||||||||
Private Label product sales | 1,297 | 2,220 | 1,752 | 244 | ||||||||||||
Rx Partner | 10,736 | 11,119 | 8,328 | 3,652 | ||||||||||||
OTC Partner | 1,858 | 1,628 | 1,769 | 1,587 | ||||||||||||
Research Partner | 2,611 | 2,833 | 2,962 | 3,274 | ||||||||||||
Promotional Partner | 3,284 | 3,224 | 3,499 | 3,441 | ||||||||||||
Other | 6 | 5 | — | 1 | ||||||||||||
Total revenues | 58,913 | 58,416 | 64,946 | 176,134 | ||||||||||||
Gross profit | 32,663 | 31,132 | 36,891 | 87,410 | ||||||||||||
Net income | $ | 2,219 | $ | 3,013 | $ | 6,685 | $ | 38,144 | ||||||||
Net income per share (basic) | $ | 0.04 | $ | 0.05 | $ | 0.11 | $ | 0.63 | ||||||||
Net income per share (diluted) | $ | 0.04 | $ | 0.05 | $ | 0.11 | $ | 0.61 | ||||||||
Weighted Average: | ||||||||||||||||
common shares outstanding: | ||||||||||||||||
Basic | 59,711,133 | 60,112,308 | 60,559,064 | 60,721,808 | ||||||||||||
Diluted | 60,222,215 | 60,552,344 | 61,247,700 | 62,288,318 | ||||||||||||
F-69
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2008 Quarters Ended: | ||||||||||||||||
(in $000’s except per share amounts) | March 31 | June 30 | September 30 | December 31 | ||||||||||||
Revenues: | ||||||||||||||||
Global product sales, gross | $ | 38,401 | $ | 45,064 | $ | 41,714 | $ | 53,694 | ||||||||
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 | 1,052 | 1,474 | 2,213 | 1,906 | ||||||||||||
Global product sales, net | 22,979 | 25,986 | 20,080 | 26,961 | ||||||||||||
Private Label product sales | 478 | 639 | 629 | 850 | ||||||||||||
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) | $ | 460 | $ | 17,088 | $ | (10,530 | ) | $ | 8,969 | |||||||
Net income (loss) per share (basic) | $ | 0.01 | $ | 0.29 | $ | (0.18 | ) | $ | 0.15 | |||||||
Net income (loss) per share (diluted) | $ | 0.01 | $ | 0.28 | $ | (0.18 | ) | $ | 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 | ||||||||||||
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(in $000’s)
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 | |||||||||||||||
Deferred tax asset valuation allowance | $ | 88,995 | $ | (78,518 | ) | $ | (10,477 | ) | $ | — | $ | — | ||||||||
Inventory reserve | 2,919 | 229 | — | — | 3,148 | |||||||||||||||
Reserve for bad debts | — | 550 | — | — | 550 |
(in $000’s)
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 | |||||||||||||||
Deferred tax asset valuation allowance | $ | — | $ | 333 | $ | — | $ | — | $ | 333 | ||||||||||
Inventory reserve | 3,148 | 1,257 | — | — | 4,405 | |||||||||||||||
Reserve for bad debts | 550 | 568 | — | (290 | ) | 828 |
(in $000’s)
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 | |||||||||||||||
Deferred tax asset valuation allowance | $ | 333 | $ | (333 | ) | $ | — | $ | — | $ | — | |||||||||
Inventory reserve | 4,405 | 241 | — | — | 4,646 | |||||||||||||||
Reserve for bad debts | 828 | 229 | — | (685 | ) | 372 |
S-1
Table of Contents
IMPAX LABORATORIES, INC. | ||||
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 | President, Chief Executive Officer (Principal Executive Officer) and Director | February 26, 2010 | ||
/s/Arthur A. Koch, Jr. | Senior Vice President, Finance, and Chief Financial Officer (Principal Financial and Accounting Officer) | February 26, 2010 | ||
/s/Leslie Z. Benet, Ph.D. | Director | February 26, 2010 | ||
/s/Robert L. Burr | Chairman of the Board | February 26, 2010 | ||
/s/Nigel Ten Fleming, Ph.D. | Director | February 26, 2010 | ||
/s/Michael Markbreiter | Director | February 26, 2010 | ||
/s/Oh Kim Sun | Director | February 26, 2010 | ||
/s/Peter R. Terreri | Director | February 26, 2010 |
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Table of Contents
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.(2) | |||
3.2 | Amended and Restated Bylaws, effective June 29, 2009.(3) | |||
4.1 | Specimen of Common Stock Certificate.(4) | |||
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.(4) | |||
4.4 | Supplemental Indenture, dated as of July 6, 2005, between the Company and HSBC Bank USA, National Association, as Trustee.(4) | |||
4.5 | Registration Rights Agreement, dated as of June 27, 2005, between the Company and the Initial Purchasers named therein.(4) | |||
4.6 | Promissory Note dated June 7, 2006, issued by the Company to Solvay Pharmaceuticals, Inc.(4) | |||
4.7 | Preferred Stock Rights Agreement, dated as of January 20, 2009, by and between the Company and StockTrans, Inc., as Rights Agent.(2) | |||
10.1.1 | Amended and Restated Loan and Security Agreement, dated as of December 15, 2005, between the Company and Wachovia Bank, National Association.(4) | |||
10.1.2 | 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.(5) | |||
10.1.3 | 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.(6) | |||
10.1.4 | Third Amendment to Amended and Restated Loan and Security Agreement, effective as of March 31, 2009, by and among the Company and Wachovia Bank, National Association.(7) | |||
10.2 | Purchase Agreement, dated June 26, 2005, between the Company and the Purchasers named therein.(4) | |||
10.3.1 | Impax Laboratories Inc. 1995 Stock Incentive Plan.*(4) | |||
10.3.2 | Amendment No. 1 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated July 1, 1998.*(6) | |||
10.3.3 | Amendment No. 2 to Impax Laboratories, Inc. 1995 Stock Incentive Plan, dated May 25, 1999.*(6) | |||
10.4.1 | Impax Laboratories Inc. 1999 Equity Incentive Plan.*(6) | |||
10.4.2 | Form of Stock Option Grant under the Impax Laboratories, Inc. 1999 Equity Incentive Plan.*(6) | |||
10.5 | Impax Laboratories Inc. 2001 Non-Qualified Employee Stock Purchase Plan.*(4) | |||
10.6.1 | Impax Laboratories Inc. Amended and Restated 2002 Equity Incentive Plan.*(8) | |||
10.6.2 | Form of Stock Option Grant under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.*(6) | |||
10.6.3 | Form of Stock Bonus Agreement under the Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan.*(6) | |||
10.6.4 | Amendment to Impax Laboratories, Inc. Amended and Restated 2002 Equity Incentive Plan, effective May 19, 2009.*(9) | |||
10.7 | Impax Laboratories Inc. Executive Non-Qualified Deferred Compensation Plan, restated effective January 1, 2005.*(5) |
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Table of Contents
Exhibit No. | Description of Document | |||
10.8.1 | Employment Agreement, dated December 14, 1999, by and between the Company and Larry Hsu, Ph.D.*(5) | |||
10.8.2 | Amendment No. 1, dated May 19, 2009, to Employment Agreement, dated December 14, 1999, by and between the Company and Larry Hsu, Ph.D.*(9) | |||
10.8.3 | Employment Agreement, dated as of January 1, 2010, between the Company and Larry Hsu, Ph.D.*(10) | |||
10.9.1 | Offer of Employment Letter, dated August 12, 2004, between the Company and Charles V. Hildenbrand.*(6) | |||
10.9.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Charles V. Hildenbrand.*(10) | |||
10.10.1 | Offer of Employment Letter, dated February 9, 2005, between the Company and Arthur A. Koch, Jr.*(6) | |||
10.10.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Arthur A. Koch, Jr.*(10) | |||
10.11.1 | Employment Agreement, dated as of September 1, 2006, between the Company and David S. Doll.*(4) | |||
10.11.2 | Separation Agreement and General Release, dated July 30, 2008, between the Company and David S. Doll.*(4) | |||
10.11.3 | Consulting Agreement, effective as of September 4, 2008, between the Company and David S. Doll.*(4) | |||
10.12.1 | Offer of Employment Letter, effective as of March 31, 2008, between the Company and Michael Nestor.*(6) | |||
10.12.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Michael J. Nestor.*(10) | |||
10.13.1 | Offer of Employment Letter, effective as of January 5, 2009, between the Company and Christopher Mengler.*(6) | |||
10.13.2 | Employment Agreement, dated as of January 1, 2010, between the Company and Christopher Mengler, R.Ph.*(10) | |||
10.14 | 2008 Cash Incentive Awards for Executive Officers.*(11) | |||
10.14.1 | Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.2 | Letter Amendment, dated October 8, 2003, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.3 | Letter Agreement, dated March 24, 2005, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.14.4 | 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.**(12) | |||
10.14.5 | Amendment, dated January 24, 2006, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(13) | |||
10.14.6 | Amendment, dated February 9, 2007, to Strategic Alliance Agreement, dated June 27, 2001, between the Company and Teva Pharmaceuticals Curacao N.V.**(12) | |||
10.15.1 | Development, License and Supply Agreement, dated as of June 18, 2002, between the Company and Wyeth, acting through its Wyeth Consumer Healthcare Division.**(12) | |||
10.15.2 | 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.(13) |
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Table of Contents
Exhibit No. | Description of Document | |||
10.15.3 | 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.(13) | |||
10.16.1 | Licensing, Contract Manufacturing and Supply Agreement, dated as of June 18, 2002, between the Company and Schering-Plough Corporation.**(13) | |||
10.16.2 | 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-Plough Corporation.**(12) | |||
10.16.3 | 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-Plough Corporation.**(12) | |||
10.17.1 | Supply and Distribution Agreement, dated as of November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(12) | |||
10.17.2 | Amendment No. 2, dated February 6, 2007, to Supply and Distribution Agreement, dated November 3, 2005, between the Company and DAVA Pharmaceuticals, Inc.**(13) | |||
10.18 | 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.(14) | |||
10.19 | 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.(14) | |||
10.20 | Sublicense Agreement, effective as of March 30, 2007, between the Company and DAVA Pharmaceuticals, Inc.(14) | |||
10.21 | Promotional Services Agreement, dated as of January 19, 2006, between the Company and Shire US Inc.(3) | |||
10.22 | License and Distribution Agreement, dated as of January 19, 2006, between the Company and Shire LLC.*** | |||
10.23 | Co-promotion Agreement, dated as of July 16, 2008, between the Company and Wyeth, acting through its Wyeth Pharmaceuticals Division.**(9) | |||
10.24 | Joint Development Agreement, dated as of November 26, 2008, between the Company and Medicis Pharmaceutical Corporation.**** | |||
10.25 | 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).(6) | |||
10.26 | 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).(6) | |||
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 on Form 10-K). | |||
21.1 | Subsidiaries of the registrant. | |||
23.1 | Consent of Grant Thornton LLP | |||
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 Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
32.2 | Certifications of the 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 granted for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. |
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Table of Contents
*** | Confidential treatment requested for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
**** | The Company is re-filing the Joint Development Agreement, dated as of November 26, 2008 (the “Joint Development Agreement”), with Medicis Pharmaceutical Corporation to disclose a milestone payment that was previously omitted in accordance with an order granting confidential treatment pursuant to Rule 24b-2 under the Exchange Act. Certain portions of the Joint Development Agreement remain confidential pursuant to an order granting confidential treatment 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 Current Report on Form 8-K filed on January 22, 2009. | |
(3) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on July 2, 2009. | |
(4) | Incorporated by reference to the Company’s Registration Statement on Form 10 filed on October 10, 2008. | |
(5) | Incorporated by reference to Amendment No. 2 to the Company’s Registration Statement on Form 10 filed on December 2, 2008. | |
(6) | Incorporated by reference to the Company’s Annual Report on Form 10-K for the year ended December 31, 2008. | |
(7) | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2009. | |
(8) | Incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed on April 8, 2009. | |
(9) | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009. | |
(10) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on January 14, 2010. | |
(11) | Incorporated by reference to the Company’s Current Report on Form 8-K filed on March 5, 2009. | |
(12) | Incorporated by reference to Amendment No. 6 to the Company’s Registration Statement on Form 10 filed on January 14, 2009. | |
(13) | Incorporated by reference to Amendment No. 1 to the Company’s Registration Statement on Form 10 filed on November 12, 2008. | |
(14) | Incorporated by reference to Amendment No. 7 to the Company’s Registration Statement on Form 10 filed on January 21, 2009. |
II-5