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1. THE COMPANY & BASIS OF PRESENTATION
Impax Laboratories, Inc. (“Impax” or “Company”) is a technology-based, specialty pharmaceutical company. The Company has two reportable segments, referred to as the “Global Pharmaceuticals Division” (“Global Division”) and the “Impax Pharmaceuticals Division” (“Impax Division”).
The Global Division develops, manufactures, sells, and distributes generic pharmaceutical products primarily through four sales channels: the “Global products” sales channel, for generic pharmaceutical prescription products the Company sells directly to wholesalers, large retail drug chains, and others; the “Private Label” sales channel, for generic pharmaceutical over-the-counter (“OTC”) and prescription products the Company sells to unrelated third-party customers who in-turn sell the product to third parties under their own label; the “Rx Partner” sales channel, for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the “OTC Partner” sales channel, for generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements. Revenues from the “Global Products” sales channel and the “Private Label” sales channel are reported under the caption “Global Product sales, net” on the consolidated statement of operations. The Company also generates revenue from research and development services provided under a joint development agreement with an unrelated third party pharmaceutical company, and reports such revenue under the caption “Research Partner” revenue on the consolidated statement of operations. The Company provides these services through the research and development group in the Global Division.
The Impax Division is engaged in the development of proprietary brand pharmaceutical products through improvements to already-approved pharmaceutical products to address central nervous system (“CNS”) disorders. The Impax Division is also engaged in product commercialization and co-promotion through a direct sales force focused on promoting to physicians, primarily in the CNS community, pharmaceutical products developed by other unrelated third-party pharmaceutical entities.
In California, the Company utilizes a combination of owned and leased facilities mainly located in Hayward. The Company’s primary properties in California consist of a leased office building used as the Company’s corporate headquarters, in addition to five properties it owns, including two research and development center facilities, and a manufacturing facility. Additionally, the Company leases three facilities in Hayward, and Fremont, utilized for additional research and development, administrative services, and equipment storage. In Pennsylvania, the Company owns a packaging, warehousing, and distribution center located in Philadelphia and leases a facility in New Britain used for sales and marketing, finance, and administrative personnel, as well as providing additional warehouse space. Outside the United States, in Taiwan, R.O.C., the Company owns a manufacturing facility.
The accompanying unaudited interim consolidated financial statements of the Company, have been prepared based upon United States Securities and Exchange Commission (“SEC”) rules permitting reduced disclosure for interim periods, and include all adjustments necessary for a fair presentation of statements of operations, statements of cash flows, and financial condition for the interim periods shown, including normal recurring accruals and other items. While certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to SEC rules and regulations, the Company believes the disclosures are adequate to make the information presented not misleading. The unaudited interim consolidated financial statements of the Company include the accounts of the operating parent company, Impax Laboratories, Inc., its wholly-owned subsidiary, Impax Laboratories (Taiwan) Inc., and an equity investment in Prohealth Biotech, Inc. (“Prohealth”), in which the Company held a 57.54% majority ownership interest at March 31, 2012. All significant intercompany accounts and transactions have been eliminated.
The unaudited results of operations and cash flows for the interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for the full year ending December 31, 2012. The unaudited interim consolidated financial statements and footnotes should be read in conjunction with the consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 as filed with the SEC, wherein a more complete discussion of significant accounting policies and certain other information can be found.
The preparation of financial statements in conformity with GAAP and the rules and regulations of the SEC requires the use of estimates and assumptions, based on complex judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The most significant judgments are employed in estimates used in determining values of tangible and intangible assets, legal contingencies, tax assets and tax liabilities, fair value of share-based compensation related to equity incentive awards issued to employees and directors, and estimates used in applying the Company’s revenue recognition policy including those related to accrued chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs, shelf-stock adjustments, and the timing and amount of deferred and recognized revenue and deferred and amortized product manufacturing costs related to alliance and collaboration agreements. Actual results may differ from estimated results. Certain prior year amounts have been reclassified to conform to the current year presentation.
In the normal course of business, the Company is subject to loss contingencies, such as legal proceedings and claims arising out of its business, covering a wide range of matters, including, among others, patent litigation, and product and clinical trial liability. In accordance with Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) Topic 450, “Contingencies”, the Company records accrued loss contingencies when it is probable a liability has been incurred and the amount of loss can be reasonably estimated. The Company, in accordance with FASB ASC Topic 450, does not recognize gain contingencies until realized.
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2. REVENUE RECOGNITION
The Company recognizes revenue when the earnings process is complete, which under SEC Staff Accounting Bulletin No. 104, Topic No. 13, “Revenue Recognition” (“SAB 104”), is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or services has occurred, the sales price is fixed or determinable, and collectability is reasonably assured.
The Company accounts for revenue arrangements with multiple deliverables in accordance with FASB ASC Topic 605-25, revenue recognition for arrangements with multiple elements, which addresses the determination of whether an arrangement involving multiple deliverables contains more than one unit of accounting. A delivered item within an arrangement is considered a separate unit of accounting only if both of the following criteria are met:
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the delivered item has value to the customer on a stand-alone basis; and |
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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. |
Under FASB ASC Topic 605-25, if both of the criteria above are not met, then separate accounting for the individual deliverables is not appropriate. Revenue recognition for arrangements with multiple deliverables constituting a single unit of accounting is recognized generally over the greater of the term of the arrangement or the expected period of performance, either on a straight-line basis or on a modified proportional performance basis.
The Company accounts for milestones related to research and development activities in accordance with FASB ASC Topic 605-28, milestone method of revenue recognition. FASB ASC Topic 605-28 allows for the recognition of consideration, which is contingent on the achievement of a substantive milestone, in its entirety in the period the milestone is achieved. A milestone is considered to be substantive if all of the following criteria are met: the milestone is commensurate with either: (1) the performance required to achieve the milestone, or (2) the enhancement of the value of the delivered items resulting from the performance required to achieve the milestone; the milestone relates solely to past performance; and, the milestone is reasonable relative to all of the deliverables and payment terms within the agreement.
Global Product sales, net:
The “Global Product sales, net” line item of the statement of operations, includes revenue recognized related to shipments of generic pharmaceutical products to the Company’s customers, primarily drug wholesalers and retail chains. Gross sales revenue is recognized at the time title and risk of loss passes to the customer, which is generally when product is received by the customer. Included in Global Product revenue are deductions from the gross sales price, including deductions related to estimates for chargebacks, rebates, returns, shelf-stock, and other pricing adjustments. The Company records an estimate for these deductions in the same period when the revenue is recognized. A summary of each of these deductions is as follows:
Chargebacks
The Company has agreements establishing contract prices for certain products with certain indirect customers, such as managed care organizations, hospitals and government agencies who purchase products from drug wholesalers. The contract prices are lower than the prices the customer would otherwise pay to the wholesaler, and the price difference is referred to as a chargeback, which generally takes the form of a credit memo issued by the Company to reduce the invoiced gross selling price charged to the wholesaler. An estimated accrued provision for chargeback deductions is recognized at the time of product shipment. The primary factors considered when estimating the provision for chargebacks are the average historical chargeback credits given, the mix of products shipped, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business. The Company also monitors actual chargebacks granted and compares them to the estimated provision for chargebacks to assess the reasonableness of the chargeback reserve at each quarterly balance sheet date.
Rebates
The Company maintains various rebate programs with its Global Division Global Products sales channel customers in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. The rebates generally take the form of a credit memo to reduce the invoiced gross selling price charged to a customer for products shipped. An estimated accrued provision for rebate deductions is recognized at the time of product shipment. The primary factors the Company considers when estimating the provision for rebates are the average historical experience of aggregate credits issued, the mix of products shipped and the historical relationship of rebates as a percentage of total gross Global Product sales, the contract terms and conditions of the various rebate programs in effect at the time of shipment, and the amount of inventory on hand at the major drug wholesalers with whom the Company does business. The Company also monitors actual rebates granted and compares them to the estimated provision for rebates to assess the reasonableness of the rebate reserve at each quarterly balance sheet date.
Returns
The Company allows its customers to return product if approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and if such products are returned within six months prior to or until twelve months following, the products’ expiration date. The Company estimates and recognizes an accrued provision for product returns as a percentage of gross sales based upon historical experience of Global Division Global Product sales. The product return reserve is estimated using a historical lag period, which is the time between when the product is sold and when it is ultimately returned and estimated return rates which may be adjusted based on various assumptions including changes to internal policies and procedures, changes in business practices, and commercial terms with customers, competitive position of each product, amount of inventory in the wholesaler supply chain, the introduction of new products, and changes in market sales information. The Company also considers other factors, including significant market changes which may impact future expected returns, and actual product returns. The Company monitors actual returns on a quarterly basis and may record specific provisions for returns it believes are not covered by historical percentages.
Shelf-Stock Adjustments
Based upon competitive market conditions, the Company may reduce the selling price of certain products. The Company may issue a credit against the sales amount to a customer based upon their remaining inventory of the product in question, provided the customer agrees to continue to make future purchases of product from the Company. This type of customer credit is referred to as a shelf-stock adjustment, which is the difference between the original selling price and the revised lower sales price, multiplied by an estimate of the number of product units on hand at a given date. Decreases in selling prices are discretionary decisions made by the Company in response to market conditions, including estimated launch dates of competing products and declines in market price. The Company records an estimate for shelf-stock adjustments in the period it agrees to grant such a credit memo to a customer.
Medicaid
As required by law, the Company provides a rebate on drugs dispensed under the Medicaid program. The Company determines its estimated Medicaid rebate accrual primarily based on historical experience of claims submitted by the various states and other jurisdictions and any new information regarding changes in the Medicaid program which may impact the Company’s estimate of Medicaid rebates. In determining the appropriate accrual amount, the Company considers historical payment rates and processing lag for outstanding claims and payments. The Company records estimates for Medicaid rebates as a deduction from gross sales, with corresponding adjustment to accrued liabilities.
Cash Discounts
The Company offers cash discounts to its customers, generally 2% of the gross selling price, as an incentive for paying within invoice terms, which generally range from 30 to 90 days. An estimate of cash discounts is recorded in the same period when revenue is recognized.
Rx Partner and OTC Partner:
The “Rx Partner” and “OTC Partner” line items of the statement of operations include revenue recognized under alliance and collaboration agreements between the Company and unrelated third-party pharmaceutical companies. The Company has entered into these alliance agreements to develop marketing and/or distribution relationships with its partners to fully leverage its technology platform.
The Rx Partners and OTC Partners alliance agreements obligate the Company to deliver multiple goods and/or services over extended periods. Such deliverables include manufactured pharmaceutical products, exclusive and semi-exclusive marketing rights, distribution licenses, and research and development services, among others. In exchange for these deliverables, the Company receives payments from its alliance agreement partners for product shipments and/or the provision of research and development services, and may also receive royalty, profit sharing, and/or upfront or periodic milestone payments. Revenue received from the alliance agreement partners for product shipments under these agreements is not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Royalty and profit sharing amounts the Company receives under these agreements are calculated by the respective alliance agreement partner, with such royalty and profit share amounts generally based upon estimates of net product sales or gross profit which include estimates of deductions for chargebacks, rebates, product returns, and other adjustments the alliance agreement partners may negotiate with their respective customers. The Company records the alliance agreement partner’s adjustments to such estimated amounts in the period the alliance agreement partner reports the amounts to the Company.
The Company applies the guidance of ASC 605-25 “Multiple Element Arrangements” to the Strategic Alliance Agreement with Teva Pharmaceuticals Curacao N.V., a subsidiary of Teva Pharmaceutical Industries Limited (“Teva Agreement”). The Company looks to the underlying delivery of goods and/or services which give rise to the payment of consideration under the Teva Agreement to determine the appropriate revenue recognition. The Company initially defers consideration received as a result of research and development-related activities performed under the Teva Agreement. The Company recognizes deferred revenue on a straight-line basis over the Company’s expected period of performance of such services. Consideration received as a result of the manufacture and delivery of products under the Teva Agreement is recognized at the time title and risk of loss passes to the customer which is generally when product is received by Teva. The Company recognizes profit share revenue in the period earned.
OTC Partner revenue is related to an agreement with Pfizer Inc. (formerly Wyeth) with respect to supply of an over-the-counter pharmaceutical product and related research and development services. The Company initially defers all revenue earned under the OTC Partner agreement. The Company also defers direct product manufacturing costs to the extent such costs are reimbursable by the OTC Partner. Product manufacturing costs in excess of amounts reimbursable by the OTC Partner are recognized as current period cost of revenue. The Company recognizes revenue as OTC Partner revenue and amortizes deferred product manufacturing costs as cost of revenues as it fulfills contractual obligations. Revenue is recognized and associated costs are amortized over the agreement’s term of the arrangement or the expected period of performance, using a modified proportional performance method. Under the modified proportional performance method of revenue recognition utilized by the Company, the amount recognized in the period of initial recognition is based upon the number of years elapsed under the alliance and collaboration agreement relative to the estimated total length of the recognition period. Under this method, the amount of revenue recognized in the year of initial recognition is determined by multiplying the total amount realized by a fraction, the numerator of which is the then current year of the alliance and collaboration agreement and the denominator of which is the total estimated life of the alliance and collaboration agreement. The amount recognized as revenue during each remaining year is an equal pro rata amount. Finally, cumulative revenue recognized is limited to the extent of cash collected and/or the fair value received. The result of the modified proportional performance method is a greater portion of the revenue is recognized in the initial period with the remaining balance being recognized ratably over either the remaining life of the arrangement or the expected period of performance of the alliance and collaboration agreement.
Research Partner:
The “Research Partner” line item of the statement of operations includes revenue recognized under development agreements with unrelated third-party pharmaceutical companies. The development agreements generally obligate the Company to provide research and development services over multiple periods. In exchange for this service, the Company received upfront payments upon signing of each development agreement and is eligible to receive contingent milestone payments, based upon the achievement of contractually specified events. Additionally, the Company may also receive royalty payments from the sale, if any, of a successfully developed and commercialized product under one of these development agreements. Revenue received from the achievement of contingent research and development milestones, if any, will be recognized in its entirety in the period when such payment is earned. Royalty fee income, if any, will be recognized by the Company in the period when the revenue is earned.
Promotional Partner:
The “Promotional Partner” line item of the statement of operations includes revenue recognized under a promotional services agreement with unrelated third-party pharmaceutical companies. The promotional services agreement obligates the Company to provide physician detailing sales calls services to promote its partners’ branded drug products over multiple periods. In exchange for this service, the Company has received fixed fees generally based on either the number of sales force representatives utilized in providing the services, or the number of sales calls made (up to contractual maximum amounts). The Company recognizes revenue from providing physician detailing sales calls services as the services are provided and as performance obligations are met and contingent payments, if any, in the period when they are earned.
Shipping and Handling Fees and Costs
Shipping and handling fees related to sales transactions are recorded as selling expense.
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3. RECENT ACCOUNTING PRONOUNCEMENTS
In May 2011, the FASB amended its guidance about fair value measurement and disclosure. The new guidance was issued in conjunction with a new International Financial Reporting Standards (“IFRS”) fair value measurement standard aimed at updating IFRS to conform to U.S. GAAP. The new FASB guidance will result in some additional disclosure requirements; however, it does not result in significant modifications to existing FASB guidance with respect to fair value measurement and disclosure. The Company was required to adopt this guidance on January 1, 2012, and it did not have a material impact on the Company’s consolidated financial statements.
In June 2011, the FASB issued Accounting Standards Update No. 2011-05, Presentation of Comprehensive Income (Topic 220), in order to increase the prominence of items reported in other comprehensive income. The amendments provide an entity with the option to present the components of net income, other comprehensive income and total comprehensive income, either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In addition, regardless of which option the entity chooses, the entity is required to present, on the face of the consolidated financial statements, reclassification adjustments for items that are reclassified from other comprehensive income to net income in the statement(s) where the components of net income and the components of other comprehensive income are presented. The requirement of this update to present the components of net income, other comprehensive income and total comprehensive income, either in a single continuous statement of comprehensive income or in two separate but consecutive statements is effective for fiscal years beginning after December 15, 2011. In December 2011, the requirement to present reclassification adjustments on the face of the consolidated financial statements was deferred indefinitely. The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
In September 2011, the FASB issued its updated guidance for the testing of goodwill for impairment. The update allows the Company the option to first assess qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If after assessing qualitative factors it is determined that it is more likely than not the fair value of the reporting unit is less than its carrying amount, the Company will need to perform a more detailed goodwill impairment test which is used to identify potential goodwill impairments and to measure the amount of goodwill impairment losses to be recognized, if any. The objective of this new approach is to simplify how entities test goodwill for impairment. The adoption of this update is not expected to have a material impact on the Company’s consolidated financial statements.
In December 2011, the FASB issued its updated guidance on balance sheet offsetting. This new standard provides guidance to determine when offsetting in the balance sheet is appropriate. The guidance is designed to enhance disclosures by requiring improved information about financial instruments and derivative instruments. The goal is to provide users of the financial statements the ability to evaluate the effect or potential effect of netting arrangements on an entity’s statement of financial position. This guidance will only impact the disclosures within an entity’s financial statements and notes to the financial statements and does not result in a change to the accounting treatment of financial instruments and derivative instruments. The Company is required to adopt this guidance on January 1, 2013. The Company is in the process of evaluating this guidance.
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4. INVESTMENTS
Investments consist of commercial paper, corporate bonds, medium-term notes, government sponsored enterprise obligations and certificates of deposit. The Company’s policy is to invest in only high quality “AAA-rated” or investment-grade securities. Investments in debt securities are accounted for as ‘held-to-maturity’ and are recorded at amortized cost, which approximates fair value, generally based upon observable market values of similar securities. The Company has historically held all investments in debt securities until maturity, and has the ability and intent to continue to do so. All of the Company’s investments have remaining contractual maturities of less than 12 months and are classified as short-term. Upon maturity, the Company uses a specific identification method.
A summary of short-term investments as of March 31, 2012 and December 31, 2011 follows:
Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
March 31, 2012 |
Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 43,692 | $ | 12 | $ | (1 | ) | $ | 43,703 | |||||||
Government sponsored enterprise obligations |
70,796 | 19 | (4 | ) | 70,811 | |||||||||||
Corporate bonds |
31,707 | 8 | (5 | ) | 31,710 | |||||||||||
Certificates of deposit |
5,007 | 2 | — | 5,009 | ||||||||||||
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Total short-term investments |
$ | 151,202 | $ | 41 | $ | (10 | ) | $ | 151,233 | |||||||
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Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2011 |
Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 69,341 | $ | 17 | $ | (5 | ) | $ | 69,353 | |||||||
Government sponsored enterprise obligations |
100,928 | 32 | (13 | ) | 100,947 | |||||||||||
Corporate bonds |
58,219 | 5 | (33 | ) | 58,191 | |||||||||||
Certificates of deposit |
13,507 | 1 | (1 | ) | 13,507 | |||||||||||
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Total short-term investments |
$ | 241,995 | $ | 55 | $ | (52 | ) | $ | 241,998 | |||||||
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5. ACCOUNTS RECEIVABLE
The composition of accounts receivable, net is as follows:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Gross accounts receivable |
$ | 165,236 | $ | 210,557 | ||||
Less: Rebate reserve |
(28,788 | ) | (29,164 | ) | ||||
Less: Chargeback reserve |
(13,256 | ) | (22,161 | ) | ||||
Less: Other deductions |
(4,009 | ) | (5,459 | ) | ||||
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Accounts receivable, net |
$ | 119,183 | $ | 153,773 | ||||
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A roll forward of the rebate and chargeback reserves activity for the three months ended March 31, 2012 and the year ended December 31, 2011 is as follows:
(in $000’s) | March 31, | December 31, | ||||||
Rebate reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 29,164 | $ | 23,547 | ||||
Provision recorded during the period |
20,589 | 79,697 | ||||||
Credits issued during the period |
(20,965 | ) | (74,080 | ) | ||||
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Ending balance |
$ | 28,788 | $ | 29,164 | ||||
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(in $000’s) | March 31, | December 31, | ||||||
Chargeback reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 22,161 | $ | 14,918 | ||||
Provision recorded during the period |
39,155 | 166,504 | ||||||
Credits issued during the period |
(48,060 | ) | (159,261 | ) | ||||
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Ending balance |
$ | 13,256 | $ | 22,161 | ||||
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Other deductions include allowance for uncollectible amounts and cash discounts. The Company maintains an allowance for doubtful accounts for estimated losses resulting from amounts deemed to be uncollectible from its customers, with such allowances for specific amounts on certain accounts. The Company recorded an allowance for uncollectible amounts of $604,000 and $612,000 at March 31, 2012 and December 31, 2011, respectively.
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6. INVENTORY
Inventory is stated at the lower of cost or market. Cost is determined using a standard cost method, and the cost flow assumption is first in, first out (“FIFO”) flow of goods. Standard costs are revised annually, and significant variances between actual costs and standard costs are apportioned to inventory and cost of goods sold based upon inventory turnover. Costs include materials, labor, quality control, and production overhead. Inventory is adjusted for short-dated, unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Consistent with industry practice, the Company may build pre-launch inventories of certain products which are pending required approval from the United States Food and Drug Administration (“FDA”) and/or resolution of patent infringement litigation, when, in the Company’s assessment, such action is appropriate to increase the commercial opportunity and FDA approval is expected in the near term and/or the litigation will be resolved in the Company’s favor. The Company accounts for all costs of idle facilities, excess freight and handling costs, and wasted materials (spoilage) as a current period charge in accordance with GAAP.
Inventory, net of carrying value reserves at March 31, 2012 and December 31, 2011 consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Raw materials |
$ | 26,723 | $ | 32,454 | ||||
Work in process |
3,834 | 5,046 | ||||||
Finished goods |
31,477 | 24,947 | ||||||
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Total inventory |
$ | 62,034 | $ | 62,447 | ||||
Less: Non-current inventory |
4,096 | 8,270 | ||||||
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Total inventory-current |
$ | 57,938 | $ | 54,177 | ||||
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Inventory carrying value reserves were $9,627,000 and $5,533,000 at March 31, 2012 and December 31, 2011, respectively.
To the extent inventory is not scheduled to be utilized in the manufacturing process and/or sold within twelve months of the balance sheet date, it is included as a component of other non-current assets. Amounts classified as non-current inventory consist of raw materials, net of valuation reserves. Raw materials generally have a shelf life of approximately three to five years, while finished goods generally have a shelf life of approximately two years.
When the Company concludes that FDA approval is expected within approximately six months for a drug product candidate, the Company may begin to schedule manufacturing process validation studies as required by FDA to demonstrate the production process can be scaled up to manufacture commercial batches. Consistent with industry practice, the Company may build quantities of unapproved product inventory pending final FDA approval and/or resolution of patent infringement litigation, when, in the Company’s assessment, such action is appropriate to increase its commercial product opportunity, and FDA approval is expected in the near term, and/or the litigation will be resolved in the Company’s favor. The carrying value of unapproved product inventory, net was $4,630,000 and $3,726,000 at March 31, 2012 and December 31, 2011, respectively. The capitalization of unapproved pre-launch inventory involves risks, including, among other items, FDA approval may not occur; approvals may require additional or different testing and/or specifications than used for unapproved inventory, and in cases where the unapproved inventory is for a product subject to litigation, the litigation may not be resolved or settled in the Company’s favor. If any of these risks were to materialize and the launch of the unapproved product inventory delayed or prevented, then the net carrying value of unapproved inventory may be partially or fully reserved.
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7. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Receivable from AstraZeneca |
$ | 45,431 | $ | — | ||||
Deferred charge-Zomig® royalty |
39,822 | — | ||||||
Other prepaid expenses |
4,042 | 6,305 | ||||||
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Prepaid expenses and other current assets |
$ | 89,295 | $ | 6,305 | ||||
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Receivable from AstraZeneca
Under the terms of the Distribution, License, Development and Supply Agreement (“AZ Agreement”) with AstraZeneca UK Limited (“AstraZeneca”), AstraZeneca is required to make payments to the Company representing 100% of the gross profit on sales of AstraZeneca-labeled Zomig® products (“transition payments”) during the period between January 1, 2012 and the date the Company begins commercialization of the products (“transition period”). The transition payments have been estimated and accounted for as a reduction of the aggregate amount of $130,000,000 to be paid by the Company to AstraZeneca during 2012. The Company received the first transition payment from AstraZeneca in April 2012 in the amount of $19,048,000. Information concerning the AZ Agreement can be found in Note 13 “Alliance and Collaboration Agreements.”
Deferred Charge-Zomig® Royalty
Under the terms of the AZ Agreement the Company is obligated to begin royalty payments to AstraZeneca on sales of Impax-labeled Zomig® products sold on or after January 1, 2013. The Company has determined the aggregate amount of $130,000,000 to be paid by the Company to AstraZeneca during 2012 under the AZ Agreement includes a royalty component for sales of Impax-labeled Zomig® products sold by the Company during 2012. The Company will record royalty expense on sales of Impax-labeled Zomig® products during 2012, and such royalty expense will be included in cost of revenues on the consolidated statement of operations.
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8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, net consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Land |
$ | 5,773 | $ | 5,773 | ||||
Buildings and improvements |
87,262 | 86,084 | ||||||
Equipment |
77,443 | 75,589 | ||||||
Office furniture and equipment |
9,365 | 8,910 | ||||||
Construction-in-progress |
25,186 | 16,602 | ||||||
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Property, plant and equipment, gross |
$ | 205,029 | $ | 192,958 | ||||
Less: Accumulated depreciation |
(78,143 | ) | (74,800 | ) | ||||
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Property, plant and equipment, net |
$ | 126,886 | $ | 118,158 | ||||
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9. GOODWILL AND INTANGIBLE ASSETS
Goodwill was $27,574,000 at March 31, 2012 and December 31, 2011, and the Company attributes the entire carrying amount of goodwill to the Global Division. Goodwill is tested at least annually for impairment or whenever events or changes in circumstances have occurred which could have a material adverse effect on the estimated fair value of the reporting unit, and thus indicate a potential impairment of the goodwill carrying value. The Company concluded the carrying value of goodwill was not impaired as of December 31, 2011.
Intangible assets consisted of the following:
(in $000’s) | Initial | Accumulated | Carrying | |||||||||
March 31, 2012 |
Cost | Amortization | Value | |||||||||
Amortized intangible assets: |
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Zomig® product rights |
$ | 44,747 | $ | — | $ | 44,747 | ||||||
Other product rights |
2,250 | — | 2,250 | |||||||||
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|||||||
Total intangible assets |
$ | 46,997 | $ | — | $ | 46,997 | ||||||
|
|
|
|
|
|
|||||||
(in $000’s) | Initial | Accumulated | Carrying | |||||||||
December 31, 2011 |
Cost | Amortization | Value | |||||||||
Amortized intangible assets: |
||||||||||||
Zomig® product rights |
$ | — | $ | — | $ | — | ||||||
Other product rights |
2,250 | — | 2,250 | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,250 | $ | — | $ | 2,250 | ||||||
|
|
|
|
|
|
The Zomig® product rights will be amortized on a straight-line basis over a period of 14 months starting in April 2012 and ending upon the expiration of the underlying patent for the tablet, over a period of 11 months starting in July 2012 and ending upon the expiration of the underlying patent for the orally disintegrating tablet, and over a period of 72 months starting in July 2012 and ending upon the estimated timing of competing generic products entering the market for the nasal spray. Amortization expense will be included as a component of cost of revenues on the consolidated statement of operations. Other product rights consist of Abbreviated New Drug Applications (“ANDAs”) which have been filed with the FDA. The Company will either commence amortization of the cost of these product rights over their estimated useful life upon FDA approval and commercialization, or will expense the related costs immediately upon failure to obtain FDA approval. Amortization expense is expected to be approximately $18,000,000 for the remainder of 2012, $13,000,000 for 2013, and $3,000,000 each year for 2014 through 2016.
|
10. ACCRUED EXPENSES, COMMITMENTS AND CONTINGENCIES
The following table sets forth the Company’s accrued expenses:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Payroll-related expenses |
$ | 11,505 | $ | 16,975 | ||||
Product returns |
22,680 | 24,101 | ||||||
Medicaid rebates |
16,546 | 17,479 | ||||||
Physician detailing sales force fees |
1,821 | 1,655 | ||||||
Legal and professional fees |
9,508 | 5,071 | ||||||
Income taxes payable |
5,164 | 1,126 | ||||||
Shelf stock price protection |
174 | 684 | ||||||
Other |
6,552 | 3,025 | ||||||
|
|
|
|
|||||
Total accrued expenses |
$ | 73,950 | $ | 70,116 | ||||
|
|
|
|
Product Returns
The Company maintains a return policy to allow customers to return product within specified guidelines. At the time of sale, the Company estimates a provision for product returns based upon historical experience for sales made through its Global Products sales channel. Sales of product under the Rx Partner, and the OTC Partners alliance and collaboration agreements are generally not subject to returns. A roll forward of the product return reserve for the three month period ended March 31, 2012 and the year ended December 31, 2011, is as follows:
(in $000’s) | March 31, | December 31, | ||||||
Returns Reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 24,101 | $ | 33,755 | ||||
Provision related to sales recorded in the period |
(329 | ) | 688 | |||||
Credits issued during the period |
(1,092 | ) | (10,342 | ) | ||||
|
|
|
|
|||||
Ending balance |
$ | 22,680 | $ | 24,101 | ||||
|
|
|
|
Taiwan Facility Construction
The Company has entered into several contracts relating to ongoing construction at its manufacturing facility located in Jhunan, Taiwan, R.O.C. As of March 31, 2012, the Company had remaining obligations under these contracts of approximately $8,100,000.
Purchase Order Commitments
As of March 31, 2012, the Company had $36,204,000 of open purchase order commitments, primarily for raw materials. The terms of these purchase order commitments are less than one year in duration.
|
11. INCOME TAXES
The Company calculates its interim income tax provision in accordance with FASB ASC Topics 270 and 740. At the end of each interim period, the Company makes an estimate of the annual United States domestic and foreign jurisdictions’ expected effective tax rates and applies these rates to its respective year-to-date taxable income or loss. The computation of the annual estimated effective tax rates at each interim period requires certain estimates and assumptions including, but not limited to, the expected operating income for the year, projections of the proportion of income (or loss) earned and taxed in United States, and the various state and local tax jurisdictions, as well as tax jurisdictions outside the United States, along with permanent differences, and the likelihood of deferred tax asset utilization. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is acquired or additional information is obtained. The computation of the annual estimated effective tax rates includes modifications, which were projected for the year, for share-based compensation, the domestic manufacturing deduction, federal and state research and development credits, among others. In addition, the effects of changes in enacted tax laws, rates, or tax status are recognized in the interim period in which the respective change occurs.
During the three month period ended March 31, 2012, the Company recognized an aggregate consolidated tax provision of $6,269,000 for United States domestic and foreign income taxes. In the three month period ended March 31, 2011, the Company recognized an aggregate consolidated tax provision of $7,144,000 for United States domestic and foreign income taxes. The decrease in the consolidated tax provision resulted from lower consolidated income before taxes in the three month period ended March 31, 2012 as compared to the same period in the prior year.
|
12. REVOLVING LINE OF CREDIT
On February 11, 2011, the Company entered into a Credit Agreement, which was subsequently amended (the “Credit Agreement”) with Wells Fargo Bank, N.A., as a lender and as administrative agent (the “Administrative Agent”). The Credit Agreement provides the Company with a revolving line of credit in the aggregate principal amount of up to $50,000,000 (the “Revolving Credit Facility”). Under the Revolving Credit Facility, up to $10,000,000 is available for letters of credit, the outstanding face amounts of which reduce availability under the Revolving Credit Facility on a dollar for dollar basis. Proceeds under the Credit Agreement may be used for working capital, general corporate and other lawful purposes. The Company has not yet borrowed any amounts under the Revolving Credit Facility.
The Company’s borrowings under the Credit Agreement are secured by substantially all of the personal property assets of the Company pursuant to a Security Agreement (the “Security Agreement”) entered into by the Company and the Administrative Agent. As further security, the Company also pledged to the Administrative Agent, 65% of the Company’s equity interest in its wholly-owned subsidiary Impax Laboratories (Taiwan), Inc. and must similarly pledge all or a portion of its equity interest in future subsidiaries. Under the Credit Agreement, among other things:
• |
The outstanding principal amount of all revolving credit loans, together with accrued and unpaid interest thereon, will be due and payable on the maturity date, which will occur four years following the February 11, 2011 closing date. |
• |
Borrowings under the Revolving Credit Facility will bear interest, at the Company’s option, at either an Alternate Base Rate (as defined in the Credit Agreement) plus the applicable margin in effect from time to time ranging from 0.5% to 1.5%, or a LIBOR Rate (as defined in the Credit Agreement) plus the applicable margin in effect from time to time ranging from 1.5% to 2.5%. The Company is also required to pay an unused commitment fee ranging from 0.25% to 0.45% per annum based on the daily average undrawn portion of the Revolving Credit Facility. The applicable margin described above and the unused commitment fee in effect at any given time will be determined based on the Company’s Total Net Leverage Ratio (as defined in the Credit Agreement), which is based upon the Company’s consolidated total debt, net of unrestricted cash in excess of $100 million, compared to Consolidated EBITDA (as defined in the Credit Agreement) for the immediately preceding four quarters. |
• |
The Company may prepay any outstanding loan under the Revolving Credit Facility without premium or penalty. |
• |
The Company is required under the Credit Agreement and the Security Agreement to comply with a number of affirmative, negative and financial covenants. Among other things, these covenants (i) require the Company to provide periodic reports, notices of material events and information regarding collateral, (ii) restrict the Company’s ability, subject to certain exceptions and baskets, to incur additional indebtedness, grant liens on assets, undergo fundamental changes, change the nature of its business, make investments, undertake acquisitions, sell assets, make restricted payments (including the ability to pay dividends and repurchase stock) or engage in affiliate transactions, and (iii) require the Company to maintain a Total Net Leverage Ratio (which is, generally, total funded debt, net of unrestricted cash in excess of $100 million, over EBITDA for the preceding four quarters) of less than 3.75 to 1.00, a Senior Secured Leverage Ratio (which is, generally, total senior secured debt over EBITDA for the preceding four quarters) of less than 2.50 to 1.00 and a Fixed Charge Coverage Ratio (which is, generally, EBITDA for the preceding four quarters over the sum of cash interest expense, cash tax payments, scheduled funded debt payments and capital expenditures during such four quarter period) of at least 2.00 to 1.00 (with each such ratio as more particularly defined as set forth in the Credit Agreement). As of March 31, 2012, the Company was in compliance with the various covenants contained in the Credit Agreement and the Security Agreement. |
• |
The Credit Agreement contains customary events of default (subject to customary grace periods, cure rights and materiality thresholds), including, among others, failure to pay principal, interest or fees, violation of covenants, material inaccuracy of representations and warranties, cross-default and cross-acceleration of material indebtedness and other obligations, certain bankruptcy and insolvency events, certain judgments, certain events related to the Employee Retirement Income Security Act of 1974, as amended, and a change of control. |
• |
Following an event of default under the Credit Agreement, the Administrative Agent would be entitled to take various actions, including the acceleration of amounts due under the Credit Agreement and seek other remedies that may be taken by secured creditors. |
Effective with the February 11, 2011 execution of the Credit Agreement discussed above, the Company’s former credit agreement under the Amended and Restated Loan and Security Agreement, dated as of December 15, 2005, as amended, between the Company and the Administrative Agent (as successor by merger to Wachovia Bank, N.A.), and its corresponding commitments were terminated. There were no amounts outstanding under the former credit agreement as of February 11, 2011. During the three months ended March 31, 2012 and 2011, unused line fees incurred under each of the credit agreements were $32,000 and $50,000, respectively.
|
13. ALLIANCE AND COLLABORATION AGREEMENTS
The Company has entered into several alliance, collaboration, license and distribution agreements, and similar agreements with respect to certain of its products and services, with unrelated third-party pharmaceutical companies. The “Rx Partner” and “OTC Partner” line items of the statement of operations include revenue recognized under agreements the Company has entered into to develop marketing and/or distribution relationships with its partners to fully leverage its technology platform. The “Research Partner” line item of the statement of operations includes revenue recognized under development agreements which generally obligate the Company to provide research and development services over multiple periods. The “Promotional Partner” line item of the statement of operations includes revenue recognized under a promotional services agreement which obligates the Company to provide physician detailing sales calls services to promote its promotional partner’s branded drug products over multiple periods.
The Company’s alliance and collaboration agreements often include milestones and provide for milestone payments upon achievement of these milestones. Generally, the milestone events contained in the Company’s alliance and collaboration agreements coincide with the progression of the Company’s products and technologies from pre-commercialization to commercialization.
The Company groups pre-commercialization milestones in its alliance and collaboration agreements into clinical and regulatory categories, each of which may include the following types of events:
Clinical Milestone Events:
• |
Designation of a development candidate. Following the designation of a development candidate, generally, IND-enabling animal studies for a new development candidate take 12 to 18 months to complete. |
• |
Initiation of a Phase I clinical trial. Generally, Phase I clinical trials take one to two years to complete. |
• |
Initiation or completion of a Phase II clinical trial. Generally, Phase II clinical trials take one to three years to complete. |
• |
Initiation or completion of a Phase III clinical trial. Generally, Phase III clinical trials take two to four years to complete. |
• |
Completion of a bioequivalence study. Generally, bioequivalence studies take three months to one year to complete. |
Regulatory Milestone Events:
• |
Filing or acceptance of regulatory applications for marketing approval such as a New Drug Application in the United States or Marketing Authorization Application in Europe. Generally, it takes six to twelve months to prepare and submit regulatory filings and approximately two months for a regulatory filing to be accepted for substantive review. |
• |
Marketing approval in a major market, such as the United States or Europe. Generally it takes one to three years after an application is submitted to obtain approval from the applicable regulatory agency. |
• |
Marketing approval in a major market, such as the United States or Europe for a new indication of an already-approved product. Generally it takes one to three years after an application for a new indication is submitted to obtain approval from the applicable regulatory agency. |
Commercialization milestones in the Company’s alliance and collaboration agreements may include the following types of events:
• |
First commercial sale in a particular market, such as in the United States or Europe. |
• |
Product sales in excess of a pre-specified threshold, such as annual sales exceeding $100 million. The amount of time to achieve this type of milestone depends on several factors including but not limited to the dollar amount of the threshold, the pricing of the product and the pace at which customers begin using the product. |
License and Distribution Agreement with Shire
In January 2006, the Company entered into a License and Distribution Agreement with an affiliate of Shire Laboratories, Inc. (“Shire License and Distribution Agreement”), under which the Company received a non-exclusive license to market and sell an authorized generic of Shire’s Adderall XR® product (“AG Product”) subject to certain conditions, but in any event by no later than January 1, 2010. The Company commenced sales of the AG Product in October 2009. Under the terms of the Shire License and Distribution Agreement, Shire is responsible for manufacturing the AG Product, and the Company is responsible for marketing and sales of the AG Product. The Company is required to pay a profit share to Shire on sales of the AG Product, of which the Company accrued a profit share payable to Shire of $25,348,000 and $16,977,000 on sales of the AG Product during the three month period ended March 31, 2012 and 2011, respectively, with a corresponding charge included in the cost of revenues line on the consolidated statement of operations.
Strategic Alliance Agreement with Teva
The Company entered into a Strategic Alliance Agreement with Teva in June 2001 (“Teva Agreement”). The Teva Agreement commits the Company to develop and manufacture, and Teva to distribute, a specified number of controlled release generic pharmaceutical products (“generic products”), each for a 10-year period. The Company identified the following deliverables under the Teva Agreement: (i) the manufacture and delivery of generic products; (ii) the provision of research and development activities (including regulatory services) related to each product; and (iii) market exclusivity associated with the products. In July 2010, the Teva Agreement was amended to terminate the provisions of the Teva Agreement with respect to the Omeprazole 10mg, 20mg and 40mg products. Additionally, in exchange for the return of product rights, the Company agreed to pay to Teva a profit share on future sales of the fexofenadine HCI/pseudoephedrine product, if any, but in no event will such profit share payments exceed an aggregate amount of $3,000,000.
The following tables show the additions to and deductions from deferred revenue under the Teva Agreement:
Three Months | ||||||||
Ended | Inception | |||||||
(in $000’s) | March 31, | Through | ||||||
Deferred revenue | 2012 | Dec 31, 2011 | ||||||
Beginning balance |
$ | 3,705 | $ | — | ||||
Additions: |
||||||||
Product related and cost sharing |
— | 427,916 | ||||||
Exclusivity charges |
— | (50,600 | ) | |||||
Other |
— | 12,527 | ||||||
|
|
|
|
|||||
Total additions |
$ | — | $ | 389,843 | ||||
|
|
|
|
|||||
Less: Amount recognized |
(327 | ) | (189,698 | ) | ||||
Accounting adjustment |
— | (196,440 | ) | |||||
|
|
|
|
|||||
Total deferred revenue |
$ | 3,378 | $ | 3,705 | ||||
|
|
|
|
The following table shows the additions to and deductions from deferred revenue and deferred product manufacturing costs under the OTC Agreements:
(in $000’s) |
Three Months Ended March 31, |
Inception Through |
||||||
Deferred revenue |
2012 | Dec 31, 2011 | ||||||
Beginning balance |
$ | 9,683 | $ | — | ||||
Additions |
315 | 100,030 | ||||||
Less: amount recognized |
(581 | ) | (90,347 | ) | ||||
|
|
|
|
|||||
Total deferred revenue |
$ | 9,417 | $ | 9,683 | ||||
|
|
|
|
|||||
(in $000’s) Deferred product manufacturing costs |
Three
Months Ended March 31, 2012 |
Inception Through Dec 31, 2011 |
||||||
Beginning balance |
$ | 8,846 | $ | — | ||||
Additions |
495 | 82,814 | ||||||
Less: amount recognized |
(661 | ) | (73,968 | ) | ||||
|
|
|
|
|||||
Total deferred product manufacturing costs |
$ | 8,680 | $ | 8,846 | ||||
|
|
|
|
Joint Development Agreement with Medicis Pharmaceutical Corporation
The Joint Development Agreement provides for the Company and Medicis to collaborate in the development of a total of four dermatology products, including three of the Company’s generic products and one branded advanced form of Medicis’s SOLODYN® product. Under the provisions of the Joint Development Agreement the Company received a $40,000,000 upfront payment, paid by Medicis in December 2008. The Company has also received an aggregate of $15,000,000 in milestone payments composed of two $5,000,000 milestone payments, paid by Medicis in March 2009 and September 2009, a $2,000,000 milestone payment paid by Medicis in December 2009, and a $3,000,000 milestone payment paid by Medicis in March 2011. The Company has the potential to receive up to an additional $8,000,000 of contingent regulatory milestone payments each of which the Company believes to be substantive, as well as the potential to receive royalty payments from sales, if any, by Medicis of its advanced form SOLODYN® brand product. Finally, to the extent the Company commercializes any of its four generic dermatology products covered by the Joint Development Agreement, the Company will pay to Medicis a gross profit share on sales of such products. The Company began commercializing one of the four dermatology products during the year ended December 31, 2011.
License, Development and Commercialization Agreement & Supply Agreement with Glaxo Group Limited
In December 2010, the Company entered into a License, Development and Commercialization Agreement with Glaxo Group Limited (“GSK”). Under the terms of the agreement with GSK, GSK received an exclusive license to develop and commercialize IPX066 throughout the world, except in the U.S. and Taiwan, and certain follow-on products at the option of GSK. GSK paid an $11,500,000 up-front payment in December 2010, and the Company has the potential to receive up to $169,000,000 of contingent milestone payments which includes $10,000,000 contingent upon the achievement of clinical events, $29,000,000 contingent upon the achievement of regulatory events, and $130,000,000 contingent upon the achievement of commercialization events. The Company believes all milestones under the agreement with GSK are substantive. The up-front payment has been deferred and is being recognized as revenue on a straight-line basis over the Company’s expected period of performance to provide research and development services, which is estimated to be the 24 month period ending December 31, 2012. The Company will also receive royalty payments on any sales of IPX066 by GSK. The Company and GSK will generally each bear its own development costs associated with its activities under the License, Development and Commercialization Agreement, except that certain development costs, including with respect to follow-on products, will be shared, as set forth in the agreement. The agreement with GSK also gives GSK the option to obtain development and commercialization rights to a future product for a one-time payment to the Company of $10,000,000. The License, Development and Commercialization Agreement will continue until GSK no longer has any royalty payment obligations to the Company, or if the agreement is terminated earlier in accordance with its terms. The License, Development and Commercialization Agreement may be terminated by GSK for convenience upon 90 days prior written notice, and may also be terminated under certain other circumstances, including material breach, as set forth in the agreement.
Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited
In January 2012, the Company entered into the AZ Agreement with AstraZeneca. Under the terms of the AZ Agreement, AstraZeneca granted to the Company an exclusive license to commercialize the tablet, orally disintegrating tablet and nasal spray formulations of Zomig® (zolmitriptan) products for the treatment of migraine headaches in the United States and in certain U.S. territories, except during an initial transition period when AstraZeneca will fulfill all orders of Zomig® products on the Company’s behalf and AstraZeneca will pay to the Company the gross profit on such Zomig® products. After a certain promotion commencement date, the Company will be obligated to fulfill certain minimum requirements with respect to the promotion of currently approved Zomig® products as well as other dosage strengths of such products approved by the FDA in the future. The Company may, but has no obligation to, develop and commercialize additional products containing zolmitriptan and additional indications for Zomig®, subject to certain restrictions as set forth in the AZ Agreement. The Company will be responsible for conducting clinical studies and preparing regulatory filings related to the development of any such additional products and would bear all related costs. During the term of the AZ Agreement, AstraZeneca will continue to be the holder of the New Drug Application for existing Zomig® products, as well as any future dosage strengths thereof approved by the FDA, and will be responsible for certain regulatory and quality-related activities for such Zomig® products. AstraZeneca will manufacture and supply Zomig® products to the Company and the Company will purchase its requirements of Zomig® products from AstraZeneca until a date determined in the AZ Agreement. Thereafter, AstraZeneca may terminate its supply obligations upon certain advance notice to the Company, in which case the Company would have the right to manufacture or have manufactured its own requirements for the applicable Zomig® product.
Under the terms of the AZ Agreement, AstraZeneca is required to make payments to the Company representing 100% of the gross profit on sales of AstraZeneca-labeled Zomig® products during the specified transition period. Under the terms of the AZ Agreement, the Company is required to make quarterly payments totaling up to $130,000,000 during 2012 to AstraZeneca. Thereafter, the Company will pay AstraZeneca tiered royalties on net sales of Zomig® products, depending on brand exclusivity and subject to customary reductions. After a certain date, the Company will also pay AstraZeneca royalties on gross profit from authorized generic products. In addition, the Company will receive the benefit of the gross profit on U.S. Zomig® sales commencing from January 1, 2012.
During the quarter ended March 31, 2012, the Company made a $25,000,000 payment to AstraZeneca pursuant to the AZ Agreement.
Development and Co-Promotion Agreement with Endo Pharmaceuticals Inc.
In June 2010, the Company and Endo Pharmaceuticals, Inc. (“Endo”) entered into a Development and Co-Promotion Agreement (“Endo Agreement”) under which the Company and Endo have agreed to collaborate in the development and commercialization of a next-generation advanced form of the Company’s lead brand product candidate (“Endo Agreement Product”). Under the provisions of the Endo Agreement, in June 2010, Endo paid to the Company a $10,000,000 up-front payment. The Company has the potential to receive up to an additional $30,000,000 of contingent milestone payments, which includes $15,000,000 contingent upon the achievement of clinical events, $5,000,000 contingent upon the achievement of regulatory events, and $10,000,000 contingent upon the achievement of commercialization events. The Company believes all milestones under the Endo Agreement are substantive. Upon commercialization of the Endo Agreement Product in the United States, Endo will have the right to co-promote such product to non-neurologists, which will require the Company to pay Endo a co-promotion service fee of up to 100% of the gross profits attributable to prescriptions for the Endo Agreement Product which are written by the non-neurologists.
The Company is recognizing the $10,000,000 up-front payment as revenue on a straight-line basis over a period of 91 months, which is the estimated expected period of performance of research and development activities under the Endo Agreement, commencing with the June 2010 effective date of the Endo Agreement and ending in December 2017, the estimated date of FDA approval of the Company’s NDA. The FDA approval of the Endo Agreement Product NDA represents the end of the Company’s expected period of performance, as the Company will have no further contractual obligation to perform research and development activities under the Endo Agreement, and therefore the earnings process will be completed. Deferred revenue is recorded as a liability captioned “Deferred revenue.” Revenue recognized under the Endo Agreement is reported on the consolidated statement of operations, in the line item captioned Research Partner. The Company determined the straight-line method aligns revenue recognition with performance as the level of research and development activities performed under the Endo Agreement are expected to be performed on a ratable basis over the Company’s estimated expected period of performance.
Upon FDA approval of the Company’s Endo Agreement Product NDA, the Company will have the right (but not the obligation) to begin manufacture and sale of such product. The Company will sell its manufactured branded product to customers in the ordinary course of business through its Impax Pharmaceuticals Division. The Company will account for any sale of the product covered by the Endo Agreement as current period revenue. The co-promotion service fee paid to Endo, as described above, if any, will be accounted for as a current period selling expense as incurred.
Co-Promotion Agreement with Pfizer
In March 2010, the Company and Pfizer, Inc. (“Pfizer”) entered into the First Amendment to the Co-Promotion Agreement (originally entered into with Wyeth, now a wholly owned subsidiary of Pfizer) (“Pfizer Co-Promotion Agreement”). Under the terms of the Pfizer Co-Promotion Agreement the Company will provide physician detailing sales call services for Pfizer’s Lyrica product to neurologists through June 30, 2012. The Company receives a fixed fee, effective January 1, 2010, subject to annual cost adjustment, for providing such physician detailing sales call services within a contractually defined range of an aggregate number of physician detailing sales calls rendered, determined on a quarterly basis. There is no opportunity for the Company to earn incentive fees under the terms of the Pfizer Co-Promotion Agreement. Pfizer is responsible for providing sales training to the Company’s physician detailing sales force personnel. Pfizer owns the product and is responsible for all pricing and marketing literature as well as product manufacture and fulfillment. The Company recognizes the physician detailing sales force fee revenue as the related services are performed and the performance obligations are met. The Company recognized $3,535,000 in both three month periods ended March 31, 2012 and 2011, under the Pfizer Co-Promotion Agreement, with such amounts presented in the line item “Promotional Partner” revenue on the consolidated statement of operations.
|
14. SHARE-BASED COMPENSATION
The Company recognizes the grant date fair value of each stock option and restricted stock award over its vesting period. Stock options and restricted stock awards are granted under the Company’s Amended and Restated 2002 Equity Incentive Plan (“2002 Plan”) and generally vest over a three or four year period and have a term of ten years. Total share-based compensation expense recognized in the consolidated statement of operations was as follows:
Three Months Ended: | ||||||||
(in $000’s) |
March
31, 2012 |
March
31, 2011 |
||||||
Manufacturing expenses |
$ | 637 | $ | 515 | ||||
Research and development |
1,213 | 953 | ||||||
Selling, general & administrative |
1,959 | 1,419 | ||||||
|
|
|
|
|||||
Total |
$ | 3,809 | $ | 2,887 | ||||
|
|
|
|
The following table summarizes stock option activity:
Number of
Shares Under Option |
Weighted
Average Exercise Price per Share |
|||||||
Outstanding at December 31, 2011 |
5,073,097 | $ | 11.76 | |||||
Options granted |
— | $ | — | |||||
Options exercised |
(482,011 | ) | $ | 8.80 | ||||
Options forfeited |
(17,392 | ) | $ | 12.44 | ||||
|
|
|||||||
Outstanding at March 31, 2012 |
4,573,694 | $ | 12.07 | |||||
|
|
|||||||
Options exercisable at March 31, 2012 |
3,001,075 | $ | 11.45 | |||||
|
|
The Company estimated the fair value of each stock option award on the grant date using the Black-Scholes option pricing model, wherein: expected volatility is based solely on historical volatility of the Company’s common stock over the period commensurate with the expected term of the stock options. The expected term calculation is based on the “simplified” method described in SAB No. 107, Share-Based Payment and SAB No. 110, Share-Based Payment, as the result of the simplified method provides a reasonable estimate in comparison to the Company’s actual experience. The risk-free interest rate is based on the U.S. Treasury yield at the date of grant for an instrument with a maturity that is commensurate with the expected term of the stock options. The dividend yield of zero is based on the fact that the Company has never paid cash dividends on its common stock, and has no present intention to pay cash dividends.
A summary of the Company’s non-vested restricted stock awards is presented below:
Restricted Stock Awards |
Number of
Restricted Stock Awards |
Weighted
Average Grant-Date Fair Value |
||||||
Non-vested at December 31, 2011 |
1,663,911 | $ | 17.20 | |||||
Granted |
57,375 | $ | 20.20 | |||||
Vested |
(58,856 | ) | $ | 7.44 | ||||
Forfeited |
(23,878 | ) | $ | 18.83 | ||||
|
|
|||||||
Non-vested at March 31, 2012 |
1,638,552 | $ | 17.63 | |||||
|
|
The Company grants restricted stock awards to certain eligible employees and directors as a component of its long-term incentive compensation program. The restricted stock award grants are made in accordance with the Company’s 2002 Plan, and typically specify the restricted stock awards underlying shares of common stock are not issued until they vest. The restricted stock awards generally vest ratably over a three or four year period from the date of grant.
As of March 31, 2012, the Company had total unrecognized share-based compensation expense, net of estimated forfeitures, of $32,950,000 related to all of its share-based awards, which will be recognized over a weighted average period of 2.30 years. As of March 31, 2012, the Company estimated 4,049,059 stock options and 1,450,599 restricted shares granted to employees which were vested or expected to vest. The intrinsic value of stock options exercised during the three month periods ended March 31, 2012 and 2011 was $6,266,000 and $8,942,000 respectively. The total fair value of restricted stock awards which vested during the three month period ended March 31, 2012 and 2011 was $435,000 and $403,000 respectively. As of March 31, 2012, the Company had 1,997,215 shares of common stock available for issuance of stock options, restricted stock awards, and/or stock appreciation rights.
|
15. STOCKHOLDERS’ EQUITY
Preferred Stock
Pursuant to its certificate of incorporation, the Company is authorized to issue 2,000,000 shares, $0.01 par value per share, “blank check” preferred stock, which enables the Board of Directors, from time to time, to create one or more new series of preferred stock. Each series of preferred stock issued can have the rights, preferences, privileges and restrictions designated by the Board of Directors. The issuance of any new series of preferred stock could affect, among other things, the dividend, voting, and liquidation rights of the Company’s common stock. During the three month periods ended March 31, 2012 and 2011, the Company did not issue any preferred stock.
Common Stock
The Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 90,000,000 shares of common stock with $0.01 par value.
Shareholders Rights Plan
On January 20, 2009, the Board of Directors approved the adoption of a shareholder rights plan and declared a dividend of one preferred share purchase right for each outstanding share of common stock of the Company. Under certain circumstances, if a person or group acquires, or announces its intention to acquire, beneficial ownership of 20% or more of the Company’s outstanding common stock, each holder of such right (other than the third party triggering such exercise), would be able to purchase, upon exercise of the right at a $15 exercise price, subject to adjustment, the number of shares of the Company’s common stock having a market value of two times the exercise price of the right. Subject to certain exceptions, if the Company is consolidated with, or merged into, another entity and the Company is not the surviving entity in such transaction or shares of the Company’s outstanding common stock are exchanged for securities of any other person, cash or any other property, or more than 50% of the Company’s assets or earning power is sold or transferred, then each holder of the rights would be able to purchase, upon the exercise of the right at a $15 exercise price, subject to adjustment, the number of shares of common stock of the third party acquirer having a market value of two times the exercise price of the right. The rights expired on January 20, 2012.
In connection with the shareholder rights plan, the Board of Directors designated 100,000 shares of series A junior participating preferred stock.
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16. EARNINGS PER SHARE
The Company’s earnings per share (EPS) includes basic net income per share, computed by dividing net income (as presented on the consolidated statement of operations), by the weighted-average number of shares of common stock outstanding for the period, along with diluted net income per share, computed by dividing net income by the weighted-average number of shares of common stock adjusted for the dilutive effect of common stock equivalents outstanding during the period. A reconciliation of basic and diluted net income per share of common stock for the three month periods ended March 31, 2012 and 2011 was as follows:
Three Months Ended: | ||||||||
(in $000’s except per share amounts) |
March
31, 2012 |
March
31, 2011 |
||||||
Numerator: |
||||||||
Net income |
$ | 12,365 | $ | 13,863 | ||||
|
|
|
|
|||||
Denominator: |
||||||||
Weighted average common shares outstanding |
65,122,240 | 63,390,527 | ||||||
Effect of dilutive stock options and restricted stock awards |
2,785,023 | 3,653,739 | ||||||
|
|
|
|
|||||
Diluted weighted average common shares outstanding |
67,907,263 | 67,044,266 | ||||||
Basic net income per share |
$ | 0.19 | $ | 0.22 | ||||
|
|
|
|
|||||
Diluted net income per share |
$ | 0.18 | $ | 0.21 | ||||
|
|
|
|
For the three month periods ended March 31, 2012 and 2011, the Company excluded 698,955 and 687,482, respectively, of shares issuable upon the exercise of stock options, and unvested restricted stock awards from the computation of diluted net income per common share as the effect of these options would have been anti-dilutive. Quarterly computations of net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
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17. SEGMENT INFORMATION
The Company has two reportable segments, the Global Division and the Impax Division. The Global Division develops, manufactures, sells, and distributes generic pharmaceutical products, primarily through the following sales channels: the Global Products sales channel, for sales of generic prescription products, directly to wholesalers, large retail drug chains, and others; the Private Label Product sales channel, for generic pharmaceutical over-the-counter and prescription products sold to unrelated third-party customers, who in-turn sell the products to third-parties under their own label; the Rx Partner sales channel, for generic prescription products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements; and the OTC Partner sales channel, for over-the-counter products sold through unrelated third-party pharmaceutical entities under their own label pursuant to alliance agreements. Revenues from the “Global Products” sales channel and the “Private Label” sales channel are reported under the caption “Global Product sales, net” on the consolidated statement of operations. The Company also generates revenue in its Global Division from research and development services provided under a joint development agreement with another unrelated third-party pharmaceutical company, and reports such revenue under the caption “Research Partner” revenue on the consolidated statement of operations.
The Impax Division is engaged in the development of proprietary branded pharmaceutical products through improvements to already-approved pharmaceutical products to address central nervous system (CNS) disorders. The Impax Division is also engaged in product commercialization and co-promotion through a direct sales force focused on promoting to physicians, primarily in the CNS community, pharmaceutical products developed by other unrelated third-party pharmaceutical entities. Additionally, the Company generates revenue in its Impax Division from research and development services provided under a development and license agreement with another unrelated third-party pharmaceutical company, and reports such revenue in the line item “Research Partner” on the consolidated statement of operations; and the Company generates revenue in its Impax Division under a License, Development and Commercialization Agreement with another unrelated third-party pharmaceutical company, and reports such revenue in the line item “Rx Partner” on the consolidated statement of operations.
The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment income (loss) before income taxes. Items below income (loss) from operations are not reported by segment, except litigation settlements, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. Additionally, general and administrative expenses, certain selling expenses, certain litigation settlements, and non-operating income and expenses are included in “Corporate and Other.” The Company does not report balance sheet information by segment since it is not reviewed by the Company’s chief operating decision maker. The accounting policies for the Company’s segments are the same as those described above in the discussion of “Revenue Recognition” and in the “Summary of Significant Accounting Policies” in the Company’s Form 10-K for the year ended December 31, 2011. The Company has no inter-segment revenue.
The tables below present segment information reconciled to total Company consolidated financial results, with segment operating income or loss including gross profit less direct research and development expenses, and direct selling expenses as well as any litigation settlements, to the extent specifically identified by segment:
(in $000’s) |
Global Division |
Impax Division |
Corporate and Other |
Total Company |
||||||||||||
Three Months Ended March 31, 2012 |
||||||||||||||||
Revenues, net |
$ | 123,265 | $ | 5,303 | $ | — | $ | 128,568 | ||||||||
Cost of revenues |
63,106 | 2,909 | — | 66,015 | ||||||||||||
Research and development |
10,662 | 8,154 | — | 18,816 | ||||||||||||
Patent Litigation |
4,038 | — | — | 4,038 | ||||||||||||
Income (loss) before provision for income taxes |
$ | 40,693 | $ | (8,821 | ) | $ | (13,270 | ) | $ | 18,602 | ||||||
Three Months Ended March 31, 2011 |
Global Division |
Impax Division |
Corporate and Other |
Total Company |
||||||||||||
Revenues, net |
$ | 103,348 | $ | 5,303 | $ | — | $ | 108,651 | ||||||||
Cost of revenues |
47,174 | 2,940 | — | 50,114 | ||||||||||||
Research and development |
9,776 | 9,714 | — | 19,490 | ||||||||||||
Patent Litigation |
1,774 | — | — | 1,774 | ||||||||||||
Income (loss) before provision for income taxes |
$ | 41,693 | $ | (8,458 | ) | $ | (12,233 | ) | $ | 21,002 |
Foreign Operations
The Company’s wholly-owned subsidiary, Impax Laboratories (Taiwan) Inc., is constructing a manufacturing facility in Jhunan, Taiwan R.O.C. which is utilized for manufacturing, research and development, warehouse, and administrative functions, with approximately $69,486,000 of net carrying value of assets, composed principally of a building and equipment, included in the Company’s consolidated balance sheet at March 31, 2012.
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18. LEGAL AND REGULATORY MATTERS
Patent Litigation
There is substantial litigation in the pharmaceutical, biological, and biotechnology industries with respect to the manufacture, use, and sale of new products which are the subject of conflicting patent and intellectual property claims. One or more patents typically cover most of the brand name controlled release products for which the Company is developing generic versions.
Under federal law, when a drug developer files an ANDA for a generic drug, seeking approval before expiration of a patent, which has been listed with the FDA as covering the brand name product, the developer must certify its product will not infringe the listed patent(s) and/or the listed patent is invalid or unenforceable (commonly referred to as a “Paragraph IV” certification). Notices of such certification must be provided to the patent holder, who may file a suit for patent infringement within 45 days of the patent holder’s receipt of such notice. If the patent holder files suit within the 45 day period, the FDA can review and approve the ANDA, but is prevented from granting final marketing approval of the product until a final judgment in the action has been rendered in favor of the generic drug developer, or 30 months from the date the notice was received, whichever is sooner. Lawsuits have been filed against the Company in connection with the Company’s Paragraph IV certifications seeking an order delaying the approval of the Company’s ANDA until expiration of the patent(s) at issue in the litigation.
Should a patent holder commence a lawsuit with respect to an alleged patent infringement by the Company, the uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. The delay in obtaining FDA approval to market the Company’s product candidates as a result of litigation, as well as the expense of such litigation, whether or not the Company is ultimately successful, could have a material adverse effect on the Company’s results of operations and financial position. In addition, there can be no assurance that any patent litigation will be resolved prior to the end of the 30-month period. As a result, even if the FDA were to approve a product upon expiration of the 30-month period, the Company may elect to not commence marketing the product if patent litigation is still pending.
The Company is generally responsible for all of the patent litigation fees and costs associated with current and future products not covered by its alliance and collaboration agreements. The Company has agreed to share legal expenses with respect to third-party and Company products under the terms of certain of the alliance and collaboration agreements. Under the Teva Agreement, the Company and Teva have agreed to share in fees and costs related to patent infringement litigation associated with the products covered by the Teva Agreement. One product under the Teva Agreement currently remains in litigation (the methylphenidate product described below), the litigation costs of which the parties share equally. In addition to the Teva Agreement, the Company is sharing litigation costs with respect to three products under the terms of two separate agreements. The Company records the costs of patent litigation as expense in the period when incurred for products it has developed, as well as for products which are the subject of an alliance or collaboration agreement with a third-party.
Although the outcome and costs of the asserted and unasserted claims is difficult to predict, the Company does not expect the ultimate liability, if any, for such matters to have a material adverse effect on its financial condition, results of operations, or cash flows.
Patent Infringement Litigation
Pfizer Inc., et al. v. Impax Laboratories, Inc. (Tolterodine LA)
In March 2008, Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB (collectively, “Pfizer”) filed a complaint against the Company in the U.S. District Court for the Southern District of New York, alleging the Company’s filing of an ANDA relating to Tolterodine Tartrate Extended Release Capsules, 4 mg, generic to Detrol® LA, infringes three Pfizer patents. The Company filed an answer and counterclaims seeking declaratory judgment of non-infringement, invalidity, or unenforceability with respect to the patents in suit. In April 2008, the case was transferred to the U.S. District Court for the District of New Jersey. On September 3, 2008, an amended complaint was filed alleging infringement based on the Company’s ANDA amendment adding a 2mg strength. For one of the patents-in-suit, U.S. Patent No. 5,382,600 (the “600 patent”), expiring on September 25, 2012 with pediatric exclusivity, the Company agreed by stipulation to be bound by the decision in Pfizer Inc. et al. v. Teva Pharmaceuticals USA, Inc., Case No. 04-1418 (D. N.J.) (“Pfizer”). After the Pfizer court conducted a bench trial, in January 2010, it found the 600 patent not invalid. That decision was appealed to the U.S. Court of Appeals for the Federal Circuit, and in July 2011 the appeal was withdrawn, making the trial court decision final and binding on the Company. Fact discovery is closed and expert discovery is proceeding in the Company’s case with respect to the other patents. Trial is set for September 4, 2012.
Warner Chilcott Company, LLC., et.al. v. Impax Laboratories, Inc. (Doxycycline Hyclate)
In December 2008, Warner Chilcott Company, LLC, Warner Chilcott (US), LLS and Mayne Pharma International Pty. Ltd. (together, “Warner Chilcott”) filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of the Company’s ANDA relating to Doxycycline Hyclate Delayed Release Tablets, 75 mg and 100 mg, generic to Doryx®. The Company filed an answer and counterclaim. Thereafter, in March 2009, Warner Chilcott filed another lawsuit in the same jurisdiction, alleging patent infringement for the filing of the Company’s ANDA for the 150 mg strength. A Markman hearing was held and a decision was issued in July 2011. A bench trial was conducted starting on February 1, 2012. In April 2012, the District Court issued its decision finding that the patent in both suits was not infringed by the Company’s ANDAs and that the patent was not invalid.
Eurand, Inc., et al. v. Impax Laboratories, Inc. (Cyclobenzaprine)
In January 2009, Eurand, Inc., Cephalon, Inc., and Anesta AG (collectively, “Cephalon”) filed suit against the Company in the U.S. District Court for the District of Delaware ("District Court"), alleging patent infringement for the filing of the Company’s ANDA relating to Cyclobenzaprine Hydrochloride Extended Release Capsules, 15 mg and 30 mg, generic to Amrix®. This matter was settled and dismissed on October 11, 2010.
On November 8, 2011, the District Court expressly named the Company in an order enjoining it from engaging in the commercial use, offer for sale, or sale within the United States of any generic Amrix®. On November 22, 2011, the Company filed a motion to reargue and modify the injunction. Plaintiffs responded on December 9, 2011, with a motion for declaratory judgment, seeking a declaration that Impax does not have the right to sell generic Amrix®. The Company responded on December 20, 2011, and moved to enforce the terms of a settlement agreement entered into with Plaintiffs that it claims grants the Company the right to sell generic Amrix®. On March 15, 2012, the District Court denied the Company’s motion and refused to modify the injunction. The Company appealed the order and the appeal is pending.
Genzyme Corporation v. Impax Laboratories, Inc. (Sevelamer Hydrochloride)
In March 2009, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Hydrochloride Tablets, 400 mg and 800 mg, generic to Renagel®. The Company filed an answer and counterclaim. Discovery is closed, and trial is scheduled for September 27, 2012.
Genzyme Corporation v. Impax Laboratories, Inc. (Sevelamer Carbonate)
In April 2009, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Carbonate Tablets, 800 mg, generic to Renvela®. The Company filed an answer and counterclaim. Discovery is closed, and trial is scheduled for September 27, 2012.
Genzyme Corporation v. Impax Laboratories, Inc. (Sevelamer Carbonate Powder)
In July 2010, Genzyme Corporation filed suit against the Company in the U.S. District Court for the District of Maryland, alleging patent infringement for the filing of the Company’s ANDA relating to Sevelamer Carbonate Powder, 2.4 g and 0.8 g packets, generic to Renvela® powder. The Company filed an answer and counterclaim. Discovery is closed, and trial is scheduled for September 27, 2012.
The Research Foundation of State University of New York et al. v. Impax Laboratories, Inc.; Galderma Laboratories Inc.,et al. v. Impax Laboratories, Inc. (Doxycycline Monohydrate)
In September 2009, The Research Foundation of State University of New York; New York University; Galderma Laboratories Inc.; and Galderma Laboratories, L.P. (collectively, “Galderma”) filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of the Company’s ANDA relating to Doxycycline Monohydrate Delayed-Release Capsules, 40 mg, generic to Oracea®. In May 2011, Galderma Laboratories Inc., Galderma Laboratories, L.P. and Supernus Pharmaceuticals, Inc. filed a second lawsuit in Delaware alleging infringement of an additional patent related to Oracea®. The Company filed an answer and counterclaims in both matters. In October 2009 for the first lawsuit and in July 2011 for the second lawsuit, the parties agreed to be bound by the final judgment concerning infringement, validity and enforceability of the patents at issue in an earlier-filed case brought by Galderma and Supernus against another generic drug manufacturer. Proceedings in the lawsuits involving the Company were stayed pending resolution of the related matter. In July 2011, a four-day trial was held in the case involving the other generic manufacturer in the U.S. District Court for the District of Delaware on the issues of patent infringement and validity. In August 2011, the Court issued its decision finding four of the five patents invalid and/or not infringed, and the fifth patent, which expires in December 2027, infringed and not invalid. The decision of the District Court will be binding on the Company unless reversed or modified on appeal or in subsequent litigation.
Shionogi Pharma, Inc. and LifeCycle Pharma A/S v. Impax Laboratories, Inc. (Fenofibrate)
In April 2010, Shionogi Pharma, Inc. and LifeCycle Pharma A/S filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement for the filing of the Company’s ANDA relating to Fenofibrate Tablets, 40 and 120 mg, generic to Fenoglide®. The Company filed an answer and counterclaims. On November 17, 2011, the Court issued an Order substituting Shore Therapeutics, Inc. for Shionogi Pharma, Inc. as plaintiff. In December 2011, the parties entered into Settlement and License Agreements and the case was dismissed in February 2012.
Schering Corporation, et al. v. Impax Laboratories, Inc. (Ezetimibe/Simvastatin)
In August 2010, Schering Corporation and MSP Singapore Company LLC (together, “Schering”) filed suit against the Company in the U.S. District Court for the District of New Jersey (“District Court”) alleging patent infringement for the filing of the Company’s ANDA relating to Ezetimibe/Simvastatin Tablets, 10/80 mg, generic to Vytorin®. The Company filed an answer and counterclaim. In December 2010, the parties agreed to be bound by the final judgment concerning validity and enforceability of the patents at issue in cases brought by Schering against other generic drug manufacturers that have filed ANDAs relating to this product, and proceedings in the Company’s case were stayed. In April 2012, the District Court issued a decision, finding that the latest-expiring patent (U.S. Patent No. RE 42,461) to be valid and enforceable. The decision of validity and enforceability will be binding on the Company unless reversed or modified on appeal or in subsequent litigation.
Abbott Laboratories, et al. v. Impax Laboratories, Inc. (Niacin-Simvastatin)
In November 2010, Abbott Laboratories and Abbott Respiratory LLC filed suit against the Company in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of the Company’s ANDA relating to Niacin-Simvastatin Tablets, 1000/20 mg, generic to Simcor®. The Company filed an answer and counterclaim. Discovery is proceeding. A final pretrial conference and Markman hearing are set for February 22, 2013. Discovery is proceeding, and no trial date has been set.
ALZA Corp., et al. v. Impax Laboratories, Inc., et al. (Methylphenidate)
In November 2010, ALZA Corp., Ortho-McNeil-Janssen Pharmaceuticals, Inc. (together, “ALZA”) filed suit against the Company in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of the Company’s ANDA relating to Methylphenidate Hydrochloride Tablets, 54 mg, generic to Concerta®. Another complaint was subsequently filed to allege infringement of the 18, 27 and 36 mg strengths, based on the Company amending its ANDA to include those additional strengths. The Company has filed its answers and counterclaims to both complaints. The parties have entered a stipulation staying the Company’s litigations until May 9, 2012.
Shire LLC, et al. v. Impax Laboratories, Inc., et al. (Guanfacine)
In December 2010, Shire LLC, Supernus Pharmaceuticals, Inc., Amy F.T. Arnsten, Ph.D., Pasko Rakic, M.D., and Robert D. Hunt, M.D. (together, “Shire”) filed suit against the Company in the U.S. District Court for the Northern District of California alleging patent infringement for the filing of the Company’s ANDA relating to Guanfacine Hydrochloride Tablets, 4 mg, generic to Intuniv®. In January, 2011 Shire amended its complaint to add the 1 mg, 2 mg, and 3 mg strengths, based on the Company amending its ANDA to include those additional strengths. The Company filed its answer and counterclaims. In September 2011, the Court amended its Scheduling Order setting the Markman hearing for May 30, 2012. No trial date has been scheduled.
Takeda Pharmaceutical Co., Ltd, et al. v. Impax Laboratories, Inc. (Dexlansoprazole)
In April 2011, Takeda Pharmaceutical Co., Ltd., Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceuticals LLC, and Takeda Pharmaceuticals America, Inc. (collectively, “Takeda”) filed suit against the Company in the U.S. District Court for the Northern District of California alleging patent infringement based on the filing of the Company’s ANDA relating to Dexlansoprazole Delayed Release Capsules, 30 and 60 mg, generic to Dexilant®. The Company filed an answer and counterclaims, including a claim relating to false marking of an expired patent. Takeda filed a motion to dismiss the Company’s false marking counterclaim. Following the enactment of the America Invents Act, the parties stipulated to dismissal of the false marking claim. The trial court issued a claim construction ruling on April 11, 2012, and discovery is ongoing. Trial is set for June 3, 2013.
Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, Board of Regents of the University of Texas System, and Grunenthal GmbH v. Impax Laboratories, Inc. (Oxycodone)
In April 2011, Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, Board of Regents of the University of Texas System, and Grunenthal GmbH (collectively “Purdue”) filed suit against the Company in the U.S. District Court for the Southern District of New York alleging patent infringement based on the filing of the Company’s ANDA relating to Oxycodone Hydrochloride, Controlled Release tablets, 10, 15, 20, 30, 40, 60 and 80 mg, generic to Oxycontin®. The Company filed an answer and counterclaims. Discovery is proceeding, and no trial date has been set.
Avanir Pharmaceuticals, Inc. et al. v. Impax Laboratories, Inc. (Dextromethorphan/Quinidine)
In August 2011, Avanir Pharmaceuticals, Inc., Avanir Holding Co., and Center for Neurological Study filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement based on the filing of the Company’s ANDA relating to Dextromethorphan/Quinidine Capsules, 20 mg/10 mg, generic of Nuedexta®. The Company filed an answer and counterclaims. Discovery is proceeding, and trial is set for September 2013.
GlaxoSmithKline LLC, et al. v. Impax Laboratories, Inc., et al. (Dutasteride/Tamsulosin)
In September 2011, GlaxoSmithKline LLC and SmithKline Beecham Corp. filed suit against the Company in the U.S. District Court for the District of Delaware alleging patent infringement based on the filing of the Company’s ANDA relating to Dutasteride/Tamsulosin Capsules, 0.5 mg/0.4 mg, generic of Jalyn®. The Company filed an answer and counterclaim. Discovery is proceeding, and trial is set for October 22, 2012.
Cephalon, Inc. et al. v. Impax Laboratories, Inc. (Fentanyl Citrate)
In November 2011, Cephalon, Inc. and CIMA Labs, Inc. (together “Cephalon”) filed suit against the Company in the U.S. District Court for the District of Delaware, alleging patent infringement for the filing of the Company’s ANDA relating to Fentanyl Citrate Buccal Tablets, 100, 200, 400, 600, and 800 mcg, generic to Fentora®. The Company filed an answer and counterclaims, as well as a declaratory judgment action to include two other patents (U.S. Patent Nos. 6,264,981 and 8,092,832). In response, Cephalon alleged infringement of those two patents against the Company. Discovery is ongoing, and trial is set for June 24, 2013.
Depomed, Inc. v. Impax Laboratories, Inc. (Gabapentin)
In April 2012, Depomed, Inc. filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of the Company’s ANDA related to Gabapentin Extended-Release Tablets, 300 and 600 mg, generic to Gralise®.
Other Litigation Related to the Company’s Business
Budeprion XL Litigation
In June 2009, the Company was named a co-defendant in class action lawsuits filed in California state court in an action titled Kelly v. Teva Pharmaceuticals Indus. Ltd, et al., No. BC414812 (Calif. Superior Crt. L.A. County). Subsequently, additional class action lawsuits were filed in Louisiana (Morgan v. Teva Pharmaceuticals Indus. Ltd, et al., No. 673880 (24th Dist Crt., Jefferson Parish, LA.)), North Carolina (Weber v. Teva Pharmaceuticals Indus., Ltd., et al., No. 07 CV5002556, (N.C. Superior Crt., Hanover County)), Pennsylvania (Rosenfeld v. Teva Pharmaceuticals USA, Inc. et al., No. 2:09-CV-2811 (E.D. Pa.)), Florida (Henchenski and Vogel v. Teva Pharmaceuticals Industries Ltd., et al., No. 2:09-CV-470-FLM-29SPC (M.D. Fla.)), Texas (Anderson v. Teva Pharmaceuticals Indus., Ltd., et al., No. 3-09CV1200-M (N.D. Tex.)), Oklahoma (Brown et al. v. Teva Pharmaceuticals Inds., Ltd., et al., No. 09-cv-649-TCK-PJC (N.D. OK)), Ohio (Latvala et al. v. Teva Pharmaceuticals Inds., Ltd., et al., No. 2:09-cv-795 (S.D. OH)), Alabama (Jordan v. Teva Pharmaceuticals Indus. Ltd et al., No. CV09-709 (Ala. Cir. Crt. Baldwin County)), and Washington (Leighty v. Teva Pharmaceuticals Indus. Ltd et al., No. CV09-01640 (W. D. Wa.)). All of the complaints involve Budeprion XL, a generic version of Wellbutrin XL® that is manufactured by the Company and marketed by Teva, and allege that, contrary to representations of Teva, Budeprion XL is less effective in treating depression, and more likely to cause dangerous side effects, than Wellbutrin XL. The actions are brought on behalf of purchasers of Budeprion XL and assert claims such as unfair competition, unfair trade practices and negligent misrepresentation under state law. Each lawsuit seeks damages in an unspecified amount consisting of the cost of Budeprion XL paid by class members, as well as any applicable penalties imposed by state law, and disclaims damages for personal injury. The state court cases were removed to federal court, and a petition for multidistrict litigation to consolidate the cases in federal court was granted. These cases and any subsequently filed cases will be heard under the consolidated action entitled In re: Budeprion XL Marketing Sales Practices, and Products Liability Litigation, MDL No. 2107, in the United States District Court for the Eastern District of Pennsylvania. The Company filed a motion to dismiss and a motion to certify that order for interlocutory appeal, both of which were denied. Plaintiffs filed a motion for class certification and the Company filed an opposition to that motion. The class certification hearing was held on May 17, 2011. In September 2011, the Company filed a summary judgment motion on the grounds of plaintiffs’ claims are preempted under federal law based on the United States Supreme Court decision in PLIVA v. Mensing. On January 6, 2012, the Company and co-defendant Teva entered into a classwide settlement agreement for all the actions included in the multidistrict litigation. Pursuant to that settlement, the Company has agreed to take certain actions related to the subject product, to pay for class notice and settlement administration, and to reimburse any attorney’s fees or costs awarded by the Court to plaintiffs’ up to a capped amount. The Company has accrued estimated costs related to the settlement of this matter as of March 31, 2012. The settlement was preliminarily approved by the Court on February 1, 2012 and remains subject to final approval following notice to the class.
Impax Laboratories, Inc. v. Shire LLC and Shire Laboratories, Inc. (generic Adderall XR®)
On November 1, 2010, the Company filed suit against Shire LLC and Shire Laboratories, Inc. (collectively “Shire”) in the Supreme Court of the State of New York, alleging breach of contract and other related claims due to Shire’s failure to fill the Company’s orders for the generic Adderall XR® product as required by the parties’ Settlement Agreement and License and Distribution Agreement, each signed in January 2006. In addition, the Company filed a motion for a preliminary injunction and a temporary restraining order seeking to require Shire to fill product orders placed by the Company. In November 2010, the case was removed to the U.S. District Court for the Southern District of New York by Shire based on diversity jurisdiction. Discovery is closed, and currently no trial date has been set.
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19. SUPPLEMENTARY FINANCIAL INFORMATION (unaudited)
Selected financial information for the quarterly period noted is as follows:
(in $000’s except shares and per share amounts) |
Quarter Ended: March 31, 2012 |
|||
Revenue: |
||||
Global Product sales, gross |
$ | 185,671 | ||
Less: |
||||
Chargebacks |
39,155 | |||
Rebates |
20,589 | |||
Product Returns |
(329 | ) | ||
Other credits |
10,045 | |||
|
|
|||
Global Product sales, net |
116,211 | |||
|
|
|||
Rx Partner |
4,416 | |||
OTC Partner |
691 | |||
Research Partner |
3,715 | |||
Promotional Partner |
3,535 | |||
|
|
|||
Total revenues |
128,568 | |||
|
|
|||
Gross profit |
62,553 | |||
Net income |
$ | 12,365 | ||
|
|
|||
Net income per share (basic) |
$ | 0.19 | ||
|
|
|||
Net income per share (diluted) |
$ | 0.18 | ||
|
|
|||
Weighted Average: |
||||
common shares outstanding: |
||||
Basic |
65,122,240 | |||
|
|
|||
Diluted |
67,907,263 | |||
|
|
Quarterly computations of net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
Selected financial information for the quarterly period noted is as follows:
(in $000’s except shares and per share amounts) |
Quarter Ended: March 31, 2011 |
|||
Revenue: |
||||
Global Product sales, gross |
$ | 151,832 | ||
Less: |
||||
Chargebacks |
35,216 | |||
Rebates |
14,777 | |||
Product Returns |
2,706 | |||
Other credits |
6,795 | |||
|
|
|||
Global Product sales, net |
92,338 | |||
|
|
|||
Rx Partner |
4,120 | |||
OTC Partner |
1,943 | |||
Research Partner |
6,715 | |||
Promotional Partner |
3,535 | |||
|
|
|||
Total revenues |
108,651 | |||
|
|
|||
Gross profit |
58,537 | |||
Net income |
$ | 13,863 | ||
|
|
|||
Net income per share (basic) |
$ | 0.22 | ||
|
|
|||
Net income per share (diluted) |
$ | 0.21 | ||
|
|
|||
Weighted Average: |
||||
common shares outstanding: |
||||
Basic |
63,390,527 | |||
|
|
|||
Diluted |
67,044,266 | |||
|
|
Quarterly computations of net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
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A summary of short-term investments as of March 31, 2012 and December 31, 2011 follows:
Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
March 31, 2012 |
Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 43,692 | $ | 12 | $ | (1 | ) | $ | 43,703 | |||||||
Government sponsored enterprise obligations |
70,796 | 19 | (4 | ) | 70,811 | |||||||||||
Corporate bonds |
31,707 | 8 | (5 | ) | 31,710 | |||||||||||
Certificates of deposit |
5,007 | 2 | — | 5,009 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total short-term investments |
$ | 151,202 | $ | 41 | $ | (10 | ) | $ | 151,233 | |||||||
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|
|
|
|
|
|||||||||
Gross | Gross | |||||||||||||||
(in $000’s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2011 |
Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 69,341 | $ | 17 | $ | (5 | ) | $ | 69,353 | |||||||
Government sponsored enterprise obligations |
100,928 | 32 | (13 | ) | 100,947 | |||||||||||
Corporate bonds |
58,219 | 5 | (33 | ) | 58,191 | |||||||||||
Certificates of deposit |
13,507 | 1 | (1 | ) | 13,507 | |||||||||||
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|
|
|
|
|
|
|
|||||||||
Total short-term investments |
$ | 241,995 | $ | 55 | $ | (52 | ) | $ | 241,998 | |||||||
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|
|
|
|
|
|
|
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The composition of accounts receivable, net is as follows:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Gross accounts receivable |
$ | 165,236 | $ | 210,557 | ||||
Less: Rebate reserve |
(28,788 | ) | (29,164 | ) | ||||
Less: Chargeback reserve |
(13,256 | ) | (22,161 | ) | ||||
Less: Other deductions |
(4,009 | ) | (5,459 | ) | ||||
|
|
|
|
|||||
Accounts receivable, net |
$ | 119,183 | $ | 153,773 | ||||
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|
|
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A roll forward of the rebate and chargeback reserves activity for the three months ended March 31, 2012 and the year ended December 31, 2011 is as follows:
(in $000’s) | March 31, | December 31, | ||||||
Rebate reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 29,164 | $ | 23,547 | ||||
Provision recorded during the period |
20,589 | 79,697 | ||||||
Credits issued during the period |
(20,965 | ) | (74,080 | ) | ||||
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|
|
|
|||||
Ending balance |
$ | 28,788 | $ | 29,164 | ||||
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|
|
|||||
(in $000’s) | March 31, | December 31, | ||||||
Chargeback reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 22,161 | $ | 14,918 | ||||
Provision recorded during the period |
39,155 | 166,504 | ||||||
Credits issued during the period |
(48,060 | ) | (159,261 | ) | ||||
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|
|
|
|||||
Ending balance |
$ | 13,256 | $ | 22,161 | ||||
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|
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Inventory, net of carrying value reserves at March 31, 2012 and December 31, 2011 consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Raw materials |
$ | 26,723 | $ | 32,454 | ||||
Work in process |
3,834 | 5,046 | ||||||
Finished goods |
31,477 | 24,947 | ||||||
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|
|
|
|||||
Total inventory |
$ | 62,034 | $ | 62,447 | ||||
Less: Non-current inventory |
4,096 | 8,270 | ||||||
|
|
|
|
|||||
Total inventory-current |
$ | 57,938 | $ | 54,177 | ||||
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|
|
|
|
Prepaid expenses and other current assets consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Receivable from AstraZeneca |
$ | 45,431 | $ | — | ||||
Deferred charge-Zomig® royalty |
39,822 | — | ||||||
Other prepaid expenses |
4,042 | 6,305 | ||||||
|
|
|
|
|||||
Prepaid expenses and other current assets |
$ | 89,295 | $ | 6,305 | ||||
|
|
|
|
|
Property, plant and equipment, net consisted of the following:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Land |
$ | 5,773 | $ | 5,773 | ||||
Buildings and improvements |
87,262 | 86,084 | ||||||
Equipment |
77,443 | 75,589 | ||||||
Office furniture and equipment |
9,365 | 8,910 | ||||||
Construction-in-progress |
25,186 | 16,602 | ||||||
|
|
|
|
|||||
Property, plant and equipment, gross |
$ | 205,029 | $ | 192,958 | ||||
Less: Accumulated depreciation |
(78,143 | ) | (74,800 | ) | ||||
|
|
|
|
|||||
Property, plant and equipment, net |
$ | 126,886 | $ | 118,158 | ||||
|
|
|
|
|
Intangible assets consisted of the following:
(in $000’s) | Initial | Accumulated | Carrying | |||||||||
March 31, 2012 |
Cost | Amortization | Value | |||||||||
Amortized intangible assets: |
||||||||||||
Zomig® product rights |
$ | 44,747 | $ | — | $ | 44,747 | ||||||
Other product rights |
2,250 | — | 2,250 | |||||||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 46,997 | $ | — | $ | 46,997 | ||||||
|
|
|
|
|
|
|||||||
(in $000’s) | Initial | Accumulated | Carrying | |||||||||
December 31, 2011 |
Cost | Amortization | Value | |||||||||
Amortized intangible assets: |
||||||||||||
Zomig® product rights |
$ | — | $ | — | $ | — | ||||||
Other product rights |
2,250 | — | 2,250 | |||||||||
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|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,250 | $ | — | $ | 2,250 | ||||||
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|
|
|
|
|
The following table sets forth the Company’s accrued expenses:
March 31, | December 31, | |||||||
(in $000’s) | 2012 | 2011 | ||||||
Payroll-related expenses |
$ | 11,505 | $ | 16,975 | ||||
Product returns |
22,680 | 24,101 | ||||||
Medicaid rebates |
16,546 | 17,479 | ||||||
Physician detailing sales force fees |
1,821 | 1,655 | ||||||
Legal and professional fees |
9,508 | 5,071 | ||||||
Income taxes payable |
5,164 | 1,126 | ||||||
Shelf stock price protection |
174 | 684 | ||||||
Other |
6,552 | 3,025 | ||||||
|
|
|
|
|||||
Total accrued expenses |
$ | 73,950 | $ | 70,116 | ||||
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|
|
|
A roll forward of the product return reserve for the three month period ended March 31, 2012 and the year ended December 31, 2011, is as follows:
(in $000’s) | March 31, | December 31, | ||||||
Returns Reserve |
2012 | 2011 | ||||||
Beginning balance |
$ | 24,101 | $ | 33,755 | ||||
Provision related to sales recorded in the period |
(329 | ) | 688 | |||||
Credits issued during the period |
(1,092 | ) | (10,342 | ) | ||||
|
|
|
|
|||||
Ending balance |
$ | 22,680 | $ | 24,101 | ||||
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|
|
|
The following tables show the additions to and deductions from deferred revenue under the Teva Agreement:
Three Months | ||||||||
Ended | Inception | |||||||
(in $000’s) | March 31, | Through | ||||||
Deferred revenue | 2012 | Dec 31, 2011 | ||||||
Beginning balance |
$ | 3,705 | $ | — | ||||
Additions: |
||||||||
Product related and cost sharing |
— | 427,916 | ||||||
Exclusivity charges |
— | (50,600 | ) | |||||
Other |
— | 12,527 | ||||||
|
|
|
|
|||||
Total additions |
$ | — | $ | 389,843 | ||||
|
|
|
|
|||||
Less: Amount recognized |
(327 | ) | (189,698 | ) | ||||
Accounting adjustment |
— | (196,440 | ) | |||||
|
|
|
|
|||||
Total deferred revenue |
$ | 3,378 | $ | 3,705 | ||||
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|
|
The following table shows the additions to and deductions from deferred revenue and deferred product manufacturing costs under the OTC Agreements:
(in $000’s) |
Three Months Ended March 31, |
Inception Through |
||||||
Deferred revenue |
2012 | Dec 31, 2011 | ||||||
Beginning balance |
$ | 9,683 | $ | — | ||||
Additions |
315 | 100,030 | ||||||
Less: amount recognized |
(581 | ) | (90,347 | ) | ||||
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|
|
|
|||||
Total deferred revenue |
$ | 9,417 | $ | 9,683 | ||||
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|
|
|
|||||
(in $000’s) Deferred product manufacturing costs |
Three
Months Ended March 31, 2012 |
Inception Through Dec 31, 2011 |
||||||
Beginning balance |
$ | 8,846 | $ | — | ||||
Additions |
495 | 82,814 | ||||||
Less: amount recognized |
(661 | ) | (73,968 | ) | ||||
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|
|
|
|||||
Total deferred product manufacturing costs |
$ | 8,680 | $ | 8,846 | ||||
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|
|
|
Total share-based compensation expense recognized in the consolidated statement of operations was as follows:
Three Months Ended: | ||||||||
(in $000’s) |
March
31, 2012 |
March
31, 2011 |
||||||
Manufacturing expenses |
$ | 637 | $ | 515 | ||||
Research and development |
1,213 | 953 | ||||||
Selling, general & administrative |
1,959 | 1,419 | ||||||
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|
|
|
|||||
Total |
$ | 3,809 | $ | 2,887 | ||||
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|
The following table summarizes stock option activity:
Number of
Shares Under Option |
Weighted
Average Exercise Price per Share |
|||||||
Outstanding at December 31, 2011 |
5,073,097 | $ | 11.76 | |||||
Options granted |
— | $ | — | |||||
Options exercised |
(482,011 | ) | $ | 8.80 | ||||
Options forfeited |
(17,392 | ) | $ | 12.44 | ||||
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|
|||||||
Outstanding at March 31, 2012 |
4,573,694 | $ | 12.07 | |||||
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|
|||||||
Options exercisable at March 31, 2012 |
3,001,075 | $ | 11.45 | |||||
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A summary of the Company’s non-vested restricted stock awards is presented below:
Restricted Stock Awards |
Number of
Restricted Stock Awards |
Weighted
Average Grant-Date Fair Value |
||||||
Non-vested at December 31, 2011 |
1,663,911 | $ | 17.20 | |||||
Granted |
57,375 | $ | 20.20 | |||||
Vested |
(58,856 | ) | $ | 7.44 | ||||
Forfeited |
(23,878 | ) | $ | 18.83 | ||||
|
|
|||||||
Non-vested at March 31, 2012 |
1,638,552 | $ | 17.63 | |||||
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|
|
A reconciliation of basic and diluted net income per share of common stock for the three month periods ended March 31, 2012 and 2011 was as follows:
Three Months Ended: | ||||||||
(in $000’s except per share amounts) |
March
31, 2012 |
March
31, 2011 |
||||||
Numerator: |
||||||||
Net income |
$ | 12,365 | $ | 13,863 | ||||
|
|
|
|
|||||
Denominator: |
||||||||
Weighted average common shares outstanding |
65,122,240 | 63,390,527 | ||||||
Effect of dilutive stock options and restricted stock awards |
2,785,023 | 3,653,739 | ||||||
|
|
|
|
|||||
Diluted weighted average common shares outstanding |
67,907,263 | 67,044,266 | ||||||
Basic net income per share |
$ | 0.19 | $ | 0.22 | ||||
|
|
|
|
|||||
Diluted net income per share |
$ | 0.18 | $ | 0.21 | ||||
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|
|
The tables below present segment information reconciled to total Company consolidated financial results, with segment operating income or loss including gross profit less direct research and development expenses, and direct selling expenses as well as any litigation settlements, to the extent specifically identified by segment:
(in $000’s) |
Global Division |
Impax Division |
Corporate and Other |
Total Company |
||||||||||||
Three Months Ended March 31, 2012 |
||||||||||||||||
Revenues, net |
$ | 123,265 | $ | 5,303 | $ | — | $ | 128,568 | ||||||||
Cost of revenues |
63,106 | 2,909 | — | 66,015 | ||||||||||||
Research and development |
10,662 | 8,154 | — | 18,816 | ||||||||||||
Patent Litigation |
4,038 | — | — | 4,038 | ||||||||||||
Income (loss) before provision for income taxes |
$ | 40,693 | $ | (8,821 | ) | $ | (13,270 | ) | $ | 18,602 | ||||||
Three Months Ended March 31, 2011 |
Global Division |
Impax Division |
Corporate and Other |
Total Company |
||||||||||||
Revenues, net |
$ | 103,348 | $ | 5,303 | $ | — | $ | 108,651 | ||||||||
Cost of revenues |
47,174 | 2,940 | — | 50,114 | ||||||||||||
Research and development |
9,776 | 9,714 | — | 19,490 | ||||||||||||
Patent Litigation |
1,774 | — | — | 1,774 | ||||||||||||
Income (loss) before provision for income taxes |
$ | 41,693 | $ | (8,458 | ) | $ | (12,233 | ) | $ | 21,002 |
|
Selected financial information for the quarterly period noted is as follows:
(in $000’s except shares and per share amounts) |
Quarter Ended: March 31, 2012 |
|||
Revenue: |
||||
Global Product sales, gross |
$ | 185,671 | ||
Less: |
||||
Chargebacks |
39,155 | |||
Rebates |
20,589 | |||
Product Returns |
(329 | ) | ||
Other credits |
10,045 | |||
|
|
|||
Global Product sales, net |
116,211 | |||
|
|
|||
Rx Partner |
4,416 | |||
OTC Partner |
691 | |||
Research Partner |
3,715 | |||
Promotional Partner |
3,535 | |||
|
|
|||
Total revenues |
128,568 | |||
|
|
|||
Gross profit |
62,553 | |||
Net income |
$ | 12,365 | ||
|
|
|||
Net income per share (basic) |
$ | 0.19 | ||
|
|
|||
Net income per share (diluted) |
$ | 0.18 | ||
|
|
|||
Weighted Average: |
||||
common shares outstanding: |
||||
Basic |
65,122,240 | |||
|
|
|||
Diluted |
67,907,263 | |||
|
|
Quarterly computations of net income per share amounts are made independently for each quarterly reporting period, and the sum of the per share amounts for the quarterly reporting periods may not equal the per share amounts for the year-to-date reporting period.
Selected financial information for the quarterly period noted is as follows:
(in $000’s except shares and per share amounts) |
Quarter Ended: March 31, 2011 |
|||
Revenue: |
||||
Global Product sales, gross |
$ | 151,832 | ||
Less: |
||||
Chargebacks |
35,216 | |||
Rebates |
14,777 | |||
Product Returns |
2,706 | |||
Other credits |
6,795 | |||
|
|
|||
Global Product sales, net |
92,338 | |||
|
|
|||
Rx Partner |
4,120 | |||
OTC Partner |
1,943 | |||
Research Partner |
6,715 | |||
Promotional Partner |
3,535 | |||
|
|
|||
Total revenues |
108,651 | |||
|
|
|||
Gross profit |
58,537 | |||
Net income |
$ | 13,863 | ||
|
|
|||
Net income per share (basic) |
$ | 0.22 | ||
|
|
|||
Net income per share (diluted) |
$ | 0.21 | ||
|
|
|||
Weighted Average: |
||||
common shares outstanding: |
||||
Basic |
63,390,527 | |||
|
|
|||
Diluted |
67,044,266 | |||
|
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