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EX-10.2 - EXHIBIT 10.2 - Impax Laboratories, LLC | c16030exv10w2.htm |
EX-10.4 - EXHIBIT 10.4 - Impax Laboratories, LLC | c16030exv10w4.htm |
EX-31.1 - EXHIBIT 31.1 - Impax Laboratories, LLC | c16030exv31w1.htm |
EX-10.3 - EXHIBIT 10.3 - Impax Laboratories, LLC | c16030exv10w3.htm |
EXCEL - IDEA: XBRL DOCUMENT - Impax Laboratories, LLC | Financial_Report.xls |
EX-32.1 - EXHIBIT 32.1 - Impax Laboratories, LLC | c16030exv32w1.htm |
EX-32.2 - EXHIBIT 32.2 - Impax Laboratories, LLC | c16030exv32w2.htm |
EX-31.2 - EXHIBIT 31.2 - Impax Laboratories, LLC | c16030exv31w2.htm |
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-34263
Impax Laboratories, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 65-0403311 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
30831 Huntwood Avenue, Hayward, CA | 94544 | |
(Address of principal executive offices) | (Zip Code) |
(510) 240-6000
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
As of May 2, 2011, there were 65,281,606 shares of the registrants common stock outstanding.
Impax Laboratories, Inc.
INDEX
Table of Contents
PART I: FINANCIAL INFORMATION
ITEM 1: | FINANCIAL STATEMENTS |
Impax Laboratories, Inc.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
(in thousands, except share and per share data)
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 140,731 | $ | 91,796 | ||||
Short-term investments |
209,225 | 256,605 | ||||||
Accounts receivable, net |
94,280 | 82,054 | ||||||
Inventory, net |
48,840 | 44,549 | ||||||
Deferred product manufacturing costs-alliance agreements |
1,334 | 2,012 | ||||||
Deferred income taxes |
39,333 | 39,271 | ||||||
Prepaid expenses and other current assets |
3,763 | 4,407 | ||||||
Total current assets |
537,506 | 520,694 | ||||||
Property, plant and equipment, net |
109,173 | 106,280 | ||||||
Deferred product manufacturing costs-alliance agreements |
8,022 | 8,223 | ||||||
Deferred income taxes, net |
8,466 | 5,069 | ||||||
Other assets |
26,934 | 25,478 | ||||||
Goodwill |
27,574 | 27,574 | ||||||
Total assets |
$ | 717,675 | $ | 693,318 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 16,014 | $ | 18,812 | ||||
Accrued expenses |
69,347 | 72,788 | ||||||
Accrued income taxes payable |
9,641 | 2,393 | ||||||
Accrued profit sharing and royalty expenses |
17,127 | 14,147 | ||||||
Deferred revenue-alliance agreements |
23,229 | 18,276 | ||||||
Total current liabilities |
135,358 | 126,416 | ||||||
Deferred revenue-alliance agreements |
32,769 | 44,195 | ||||||
Other liabilities |
16,656 | 14,558 | ||||||
Total liabilities |
$ | 184,783 | $ | 185,169 | ||||
Commitments and contingencies (Note 8) |
||||||||
Stockholders equity: |
||||||||
Preferred Stock, $0.01 par value, 2,000,000 shares authorized,
0 shares outstanding at March 31, 2011 and December 31, 2010 |
$ | | $ | | ||||
Common stock, $0.01 par value, 90,000,000 shares authorized and
65,323,182 and 64,721,041 shares issued at March 31, 2011
and December 31, 2010, respectively |
653 | 647 | ||||||
Additional paid-in capital |
266,745 | 255,440 | ||||||
Treasury stock 243,729 shares |
(2,157 | ) | (2,157 | ) | ||||
Accumulated other comprehensive income |
2,385 | 2,811 | ||||||
Retained earnings |
265,109 | 251,246 | ||||||
532,735 | 507,987 | |||||||
Noncontrolling interest |
157 | 162 | ||||||
Total stockholders equity |
532,892 | 508,149 | ||||||
Total liabilities and stockholders equity |
$ | 717,675 | $ | 693,318 | ||||
The accompanying notes are an integral part of these interim consolidated financial statements.
1
Table of Contents
Impax Laboratories, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(dollars in thousands, except share and per share data)
(dollars in thousands, except share and per share data)
Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2011 | 2010 | |||||||
(unaudited) | (unaudited) | |||||||
Revenues: |
||||||||
Global Product sales, net |
$ | 91,946 | $ | 309,105 | ||||
Private Label Product sales |
392 | 672 | ||||||
Rx Partner |
4,120 | 4,903 | ||||||
OTC Partner |
1,943 | 1,765 | ||||||
Research Partner |
6,715 | 3,385 | ||||||
Promotional Partner |
3,535 | 3,503 | ||||||
Total revenues |
108,651 | 323,333 | ||||||
Cost of revenues |
50,114 | 79,576 | ||||||
Gross profit |
58,537 | 243,757 | ||||||
Operating expenses: |
||||||||
Research and development |
19,490 | 18,309 | ||||||
Patent litigation |
1,774 | 1,984 | ||||||
Selling, general and administrative |
16,579 | 12,485 | ||||||
Total operating expenses |
37,843 | 32,778 | ||||||
Income from operations |
20,694 | 210,979 | ||||||
Other (expense) income, net |
3 | (18 | ) | |||||
Interest income |
321 | 82 | ||||||
Interest expense |
(16 | ) | (46 | ) | ||||
Income before income taxes |
21,002 | 210,997 | ||||||
Provision for income taxes |
7,144 | 79,484 | ||||||
Net income before noncontrolling interest |
13,858 | 131,513 | ||||||
Add back loss (gain) attributable to
noncontrolling interest |
5 | (28 | ) | |||||
Net income |
$ | 13,863 | $ | 131,485 | ||||
Net Income per share: |
||||||||
Basic |
$ | 0.22 | $ | 2.16 | ||||
Diluted |
$ | 0.21 | $ | 2.06 | ||||
Weighted average common shares outstanding: |
||||||||
Basic |
63,390,527 | 61,008,015 | ||||||
Diluted |
67,044,266 | 63,865,678 | ||||||
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
2
Table of Contents
Impax Laboratories, Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(dollars in thousands)
(dollars in thousands)
Three Months Ended | ||||||||
March 31, | March 31, | |||||||
2011 | 2010 | |||||||
(unaudited) | (unaudited) | |||||||
Cash flows from operating activities: |
||||||||
Net income |
$ | 13,863 | $ | 131,485 | ||||
Adjustments to reconcile net income to net cash provided by
operating activities: |
||||||||
Depreciation and amortization |
3,457 | 2,946 | ||||||
Amortization of Credit Agreement deferred financing costs |
5 | 25 | ||||||
Accretion of interest income on short-term investments |
(245 | ) | (64 | ) | ||||
Deferred income taxes (benefit) |
(1,106 | ) | 1,889 | |||||
Provision for uncertain tax positions |
40 | 12 | ||||||
Tax benefit related to the exercise of employee stock options |
(2,353 | ) | (738 | ) | ||||
Deferred revenue-Alliance Agreements |
910 | 5,495 | ||||||
Deferred product manufacturing costs-Alliance Agreements |
(478 | ) | (3,427 | ) | ||||
Recognition of deferred revenue-Alliance Agreements |
(7,384 | ) | (10,053 | ) | ||||
Amortization of deferred product manufacturing costs-Alliance Agreements |
1,357 | 4,249 | ||||||
Accrued profit sharing and royalty expense |
17,090 | 41,307 | ||||||
Payments of profit sharing and royalty expense |
(14,139 | ) | (53,695 | ) | ||||
Payments of accrued litigation settlements |
| (5,865 | ) | |||||
Share-based compensation expense |
2,887 | 2,873 | ||||||
Bad debt expense |
62 | 91 | ||||||
Changes in certain assets and liabilities: |
||||||||
Accounts receivable |
(12,288 | ) | (138,929 | ) | ||||
Inventory |
(4,291 | ) | (2,885 | ) | ||||
Prepaid expenses and other assets |
(949 | ) | (3,870 | ) | ||||
Accounts payable, accrued expenses and income taxes payable |
2,518 | 64,678 | ||||||
Other liabilities |
2,055 | 2,088 | ||||||
Net cash provided by operating activities |
$ | 1,011 | $ | 37,612 | ||||
Cash flows from investing activities: |
||||||||
Purchase of short-term investments |
(87,783 | ) | (23,055 | ) | ||||
Maturities of short-term investments |
135,408 | 35,103 | ||||||
Purchases of property, plant and equipment |
(8,723 | ) | (3,116 | ) | ||||
Net cash provided by investing activities |
$ | 38,902 | $ | 8,932 | ||||
Cash flows from financing activities: |
||||||||
Tax benefit related to the exercise of employee stock options |
2,353 | 738 | ||||||
Proceeds from exercise of stock options and ESPP |
6,669 | 4,695 | ||||||
Net cash provided by financing activities |
$ | 9,022 | $ | 5,433 | ||||
Net increase in cash and cash equivalents |
$ | 48,935 | $ | 51,977 | ||||
Cash and cash equivalents, beginning of period |
$ | 91,796 | $ | 31,770 | ||||
Cash and cash equivalents, end of period |
$ | 140,731 | $ | 83,747 | ||||
3
Table of Contents
Supplemental disclosure of non-cash investing and financing activities:
Three Months Ended | ||||||||
March 31, | March 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Cash paid for interest |
$ | 130 | $ | 46 | ||||
Cash paid for income taxes |
$ | 974 | $ | 30,710 | ||||
Accrued vendor invoices of approximately $1,040,000 and $4,898,000 at March 31, 2011 and 2010,
respectively, are excluded from the purchase of property, plant, and equipment and the change in
accounts payable and accrued expenses.
Depreciation expense was $3,289,000 and $2,946,000 for the three months ended March 31, 2011
and 2010, respectively.
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
4
Table of Contents
NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
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 sales of
generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities
under their own label pursuant to alliance agreements. 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 Companys 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 the co-promotion of
pharmaceutical products developed by other unrelated third-party pharmaceutical entities through a
direct sales force focused on marketing to physicians, primarily in the CNS community.
In California, the Company utilizes a combination of owned and leased facilities mainly
located in Hayward. The Companys primary properties in California consist of a leased office
building used as the Companys corporate headquarters, in addition to three 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 Unites States, in Taiwan, 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, 2011. 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 Companys operations for any other interim period or for the full
year ending December 31, 2011. The unaudited interim consolidated financial statements and
footnotes should be read in conjunction with the consolidated financial statements and footnotes
included in the Companys Annual Report on Form 10-K for the year ended December 31, 2010 as filed
with the SEC, wherein a more complete discussion of significant accounting policies and certain
other information can be found.
5
Table of Contents
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States (GAAP) and the rules and regulations of the U.S. Securities and
Exchange Commission (SEC) requires the use of estimates and assumptions, based on complex judgments
considered reasonable, 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 Companys 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.
6
Table of Contents
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 the delivered item meets both of the following criteria: the delivered item has
value to the customer on a stand alone basis; and if the arrangement includes a general right of
return relative to the delivered item, delivery or performance of the undelivered item is
considered probable and substantially in the control of the vendor. Under FASB ASC Topic 605-25,
if both of these criteria 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 recognizable 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 proportional
performance basis. Prior to the application of the updated guidance of FASB ASC Topic 605-25 for
multiple element arrangements in 2010, (see the Alliance and Collaboration Agreements footnote
below for a detailed discussion) delivered items within the Companys arrangements were not
considered a separate unit of accounting as the fair value of the undelivered elements could not be
objectively or reliably determined.
The Company accounts for milestones related to research and development activities in
accordance with the milestone method of revenue recognition of FASB ASC Topic 605-28, under which
consideration contingent on the achievement of a substantive milestone is recognized in its
entirety in the period when the milestone is achieved. A milestone is considered to be substantive
when it meets all of the following criteria: the milestone is commensurate with either the
performance required to achieve the milestone or 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.
7
Table of Contents
2. REVENUE RECOGNITION (continued)
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 Companys customers,
primarily drug wholesalers and retail chains. Gross sales revenue is recognized at the time title
and risk of loss passes to the customer generally when product is received by the customer.
Included in Global Product sales, net revenue are deductions from the gross selling price related
to estimates for chargebacks, rebates, product returns, shelf-stock, and other pricing adjustments.
The Company records an estimate for these deductions in the same period when the gross sales
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. A provision for chargeback deductions is estimated and
recorded 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 aggregate 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. A provision for rebate
deductions is estimated and recorded 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
aggregate 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 Company personnel
in writing or by telephone with the lot number and expiration date accompanying any request and if
such products are returned either within six months prior to or until twelve months after, the
products expiration date. The Company estimates a 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 return rates, adjusted by estimates of
the future return rates based on various assumptions, which may include 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 and /or any
of the other aforementioned factors.
8
Table of Contents
2. REVENUE RECOGNITION (continued)
Shelf-Stock Adjustments
Based upon competitive market conditions, the Company may reduce the selling price of
particular products to particular customers for certain future product shipments. 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 selling price credit memo is referred to as a shelf-stock
adjustment, which is the difference between the original selling price and the revised selling
price, multiplied by an estimate of the number of product units on hand at a given date. These
selling price reductions are discretionary decisions made by the Company in response to market
conditions, including estimated launch dates of competing products and estimated declines in market
price. The Company records an estimate for shelf-stock adjustments in the period it incurs the
cost of the selling price reductions, which is generally the date on which the Company has agreed
to grant an estimated credit memo to a particular customer for a certain product.
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 Companys 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 revenue, with corresponding adjustment to the
accrued Medicaid reserve liability.
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 gross sales revenue is recognized.
9
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2. REVENUE RECOGNITION (continued)
Private Label Product sales
The Company recognizes revenue from Private Label Product sales in accordance with SAB 104.
Revenue from direct product sales is recognized at the time title and risk of loss pass to
customers. Revenue received from Private Label product sales is not subject to deductions for
chargebacks, rebates, returns, shelf-stock adjustments, and other pricing adjustments.
Additionally, Private Label product sales do not have upfront, milestone, or lump-sum payments and
do not contain multiple deliverables under FASB ASC Topic 605.
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-parties, generally other pharmaceutical companies. The Company has entered into these
alliance and collaboration 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, development, commercialization, and /or
distribution licenses, and research and development services, among others. In exchange for these
deliverables, the Company receives payments from its alliance and collaboration 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 and collaboration 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 and
collaboration agreement partners may negotiate with their respective customers. The Company
records the alliance agreement partners adjustments to such estimated amounts as incurred, which
is generally in the period the alliance agreement partner reports the amounts to the Company.
The Company applied the updated 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) during the year ended December 31, 2010.
All consideration received under the Teva Agreement is contingent, and therefore cannot be
allocated to the deliverables. 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. Consideration received as a result of research and
development-related activities performed under the Teva Agreement are initially deferred and
recorded as a liability captioned Deferred revenue-alliance agreements. The Company recognizes
the deferred revenue on a straight-line basis over the Companys 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
generally when product is received by Teva. The Company recognizes profit share revenue in the
period it is earned.
10
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2. REVENUE RECOGNITION (continued)
OTC Partner revenue is related to the Companys supply of over-the-counter pharmaceutical
products and related research and development services under alliance agreements with Pfizer Inc.
(formerly Wyeth) and previously with Merck & Co., Inc. (formerly Schering-Plough Corporation) (OTC
Partner alliance agreements). The Company initially defers all revenue earned under its OTC
Partner alliance agreements. The deferred revenue is recorded as a liability captioned Deferred
revenue alliance agreements. The Company also defers its direct product manufacturing costs to
the extent such costs are reimbursable by the OTC Partners. These deferred product manufacturing
costs are recorded as an asset captioned Deferred product manufacturing costs alliance
agreements. The product manufacturing costs in excess of amounts reimbursable by the OTC Partners
are recognized as cost of revenue in the period incurred. The Company recognizes revenue as OTC
Partner revenue and amortizes deferred product manufacturing costs as cost of revenues as the
Company fulfills its contractual obligations. Revenue is recognized and associated costs are
amortized over the respective alliance agreements term of the arrangement or the Companys
expected period of performance, using a modified proportional performance method, under which the
amount recognized in the period of initial recognition is based upon the number of years elapsed
under the respective alliance agreement relative to the estimated total length of the recognition
period, resulting in an amount of revenue recognized in the year of initial recognition being
determined by multiplying the total amount realized by a fraction, the numerator of which is the
then current year of the alliance agreement and the denominator of which is the total estimated
life of the alliance agreement. The amount recognized 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 Companys 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 Companys
expected period of performance of each respective alliance agreement.
Research Partner:
The Research Partner line item of the statement of operations includes revenue recognized
under development agreements with unrelated third-parties, generally other 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
provision of research and development services, including the upfront payment and milestone
payments received before January 1, 2011, are deferred and recognized on a straight line basis over
the expected period of performance of the research and development services. Revenue received from
the achievement of contingent research and development milestones, if any, after January 1, 2011,
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 an unrelated third-party pharmaceutical company. The
promotional services agreement obligates the Company to provide physician detailing sales calls
services to promote its promotional partners branded drug products over multiple periods. In
exchange for this service, the Company receives 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 March 2010, the FASB issued Accounting Standards Update No. 2010-17, Revenue
Recognition-Milestone Method of Revenue Recognition (Topic 605), which addresses accounting for
arrangements in which a vendor satisfies its performance obligations over time, with all or a
portion of the consideration contingent on future events, referred to as milestones. The
Milestone Method of Revenue Recognition is limited to arrangements which involve research or
development activities. A milestone is defined as an event for which, at the date the arrangement
is entered into, there is substantive uncertainty whether the event will be achieved, and the
achievement of the event is based in whole or in part on either the vendors performance or a
specific outcome resulting from the vendors performance. In addition, the achievement of the event
would result in additional payments being due to the vendor. The Milestone Method of Revenue
Recognition allows a vendor to adopt an accounting policy to recognize arrangement consideration
that is contingent on the achievement of a substantive milestone in its entirety in the period the
milestone is achieved. The Milestone Method of Revenue Recognition is effective on a prospective
basis, with an option for retrospective application for milestones achieved in fiscal years and
interim periods within those fiscal years beginning on or after June 15, 2010. The Company
recognized $3.0 million of revenue for a research and development milestone achieved during the
three months ended March 31, 2011 pursuant to the terms of the Joint Development Agreement with
Medicis Pharmaceutical Corporation.
In December 2010, the FASB issued Accounting Standards Update No. 2010-27, Fees Paid to the
Federal Government by Pharmaceutical Manufacturers (Subtopic 720-50), which provides guidance on
the annual fee paid by pharmaceutical manufacturers to the U.S. Treasury in accordance with the
Patient Protection and Affordable Care Act as amended by the Health Care and Education
Reconciliation Act (the Acts). The Acts impose an annual fee on the pharmaceutical manufacturing
industry for each calendar year beginning on or after January 1, 2011. An entitys portion of the
annual fee is payable no later than September 30 of the applicable calendar year and is not tax
deductible. The annual fee ranges from $2.5 billion to $4.1 billion in total, a portion of which
will be allocated to individual entities on the basis of the amount of their branded prescription
drug sales for the preceding year as a percentage of the industrys branded prescription drug sales
for the same period. An entitys portion of the annual fee becomes payable to the U.S. Treasury
once a pharmaceutical manufacturing entity has a gross receipt from branded prescription drug sales
to any specified government program or in accordance with coverage under any government program for
each calendar year beginning on or after January 1, 2011. The liability related to the annual fee
imposed by the Acts shall be estimated and recorded in full upon the first qualifying sale with a
corresponding deferred cost that is amortized to expense using a straight-line method of allocation
unless another method better allocates the fee over the calendar year that it is payable. The
guidance in Subtopic 720-50 becomes effective for calendar years beginning after December 31, 2010.
Upon becoming effective this update did not have a material impact on the Companys consolidated
financial statements.
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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 Companys 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 Companys 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, 2011 and December 31, 2010 follows:
Gross | Gross | |||||||||||||||
(in $000s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
March 31, 2011 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 96,253 | $ | 26 | $ | (1 | ) | $ | 96,278 | |||||||
Government sponsored
enterprise obligations |
55,190 | 24 | | 55,214 | ||||||||||||
Corporate bonds |
39,596 | 4 | (15 | ) | 39,585 | |||||||||||
Certificates of deposit |
18,186 | 13 | (2 | ) | 18,197 | |||||||||||
Total short-term investments |
$ | 209,225 | $ | 67 | $ | (18 | ) | $ | 209,274 | |||||||
Gross | Gross | |||||||||||||||
(in $000s) | Amortized | Unrecognized | Unrecognized | Fair | ||||||||||||
December 31, 2010 | Cost | Gains | Losses | Value | ||||||||||||
Commercial paper |
$ | 168,260 | $ | 36 | $ | (7 | ) | $ | 168,289 | |||||||
Government sponsored
enterprise obligations |
56,866 | 40 | (1 | ) | 56,905 | |||||||||||
Corporate bonds |
18,316 | 15 | (13 | ) | 18,318 | |||||||||||
Certificates of deposit |
13,163 | 13 | | 13,176 | ||||||||||||
Total short-term investments |
$ | 256,605 | $ | 104 | $ | (21 | ) | $ | 256,688 | |||||||
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5. ACCOUNTS RECEIVABLE
The composition of accounts receivable, net is as follows:
March 31, | December 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Gross accounts receivable |
$ | 125,945 | $ | 123,941 | ||||
Less: Chargeback reserve |
(9,743 | ) | (14,918 | ) | ||||
Less: Rebate reserve |
(16,174 | ) | (20,892 | ) | ||||
Less: Other deductions |
(5,748 | ) | (6,077 | ) | ||||
Accounts receivable, net |
$ | 94,280 | $ | 82,054 | ||||
A roll forward of the chargeback and rebate reserves activity for the three months ended March
31, 2011 and the year ended December 31, 2010 is as follows:
(in $000s) | March 31, | December 31, | ||||||
Chargeback reserve | 2011 | 2010 | ||||||
Beginning balance |
$ | 14,918 | $ | 21,448 | ||||
Provision recorded during the period |
35,216 | 181,566 | ||||||
Credits issued during the period |
(40,391 | ) | (188,096 | ) | ||||
Ending balance |
$ | 9,743 | $ | 14,918 | ||||
(in $000s) | March 31, | December 31 | ||||||
Rebate reserve | 2011 | 2010 | ||||||
Beginning balance |
$ | 20,892 | $ | 37,781 | ||||
Provision recorded during the period |
12,709 | 91,064 | ||||||
Credits issued during the period |
(17,427 | ) | (107,953 | ) | ||||
Ending balance |
$ | 16,174 | $ | 20,892 | ||||
Other deductions include allowance for uncollectible amounts and cash discounts. The Company
maintains an allowance for uncollectible amounts for estimated losses resulting from amounts deemed
to be uncollectible from its customers, with such allowances for specific amounts on certain
customer accounts. The Company recorded an allowance for uncollectible amounts of $599,000 and
$539,000 at March 31, 2011 and December 31, 2010, respectively.
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6. INVENTORY
Inventory, net at March 31, 2011 and December 31, 2010 consisted of the following:
March 31, | December 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Raw materials |
$ | 27,609 | $ | 27,871 | ||||
Work in process |
3,174 | 2,575 | ||||||
Finished goods |
23,482 | 20,545 | ||||||
Total inventory, net |
$ | 54,265 | $ | 50,991 | ||||
Less: Non-current inventory, net |
(5,425 | ) | (6,442 | ) | ||||
Total inventory-current, net |
$ | 48,840 | $ | 44,549 | ||||
The inventory carrying value reserves included in the inventory, net presented above amounted
to $8,225,000 and $5,344,000 at March 31, 2011 and December 31, 2010, 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 classified as non-current inventory and
is included as a component of other assets in the consolidated balance sheets. Amounts classified
as non-current inventory consist of raw materials, net of carrying value 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 United States Food and Drug Administration (FDA) approval is
expected within approximately six months, the Company will generally 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 pre-launch inventories of certain products pending required final FDA
approval and /or resolution of patent infringement litigation, when, in the Companys assessment,
such action is appropriate to increase the commercial opportunity, FDA approval is expected in the
near term, and/or the litigation will be resolved in the Companys favor. The Company recognizes
pre-launch inventories at the lower of its cost or the expected net selling price. Cost is
determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of
goods. Costs of unapproved products are the same as approved products and include materials, labor,
quality control, and production overhead. The carrying value of unapproved inventory, less
reserves, was approximately $2,004,000 and $2,117,000 at March 31, 2011 and December 31, 2010,
respectively. The capitalization of unapproved pre-launch inventory involves risks, including,
among other items, FDA approval of product 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 favor of the Company. If any of these risks were to materialize and the launch of the
unapproved product delayed or prevented, then the carrying value of unapproved inventory may be
partially or fully reserved. Generally, the selling price of a generic pharmaceutical product is at
discount from the corresponding brand product selling price. Typically, a generic drug is easily
substituted for the corresponding brand product, and once a generic product is approved, the
pre-launch inventory is typically sold within the next three months. If the market prices become
lower than the product inventory carrying costs, then the pre-launch inventory value is reduced to
such lower market value. If the inventory produced exceeds the estimated market acceptance of the
generic product and becomes short-dated, a carrying value reserve will be recorded. In all cases,
the carrying value of the Companys pre-launch product inventory is lower than the respective
estimated net selling prices.
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7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, net consisted of the following:
March 31, | December 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Land |
$ | 3,670 | $ | 2,270 | ||||
Buildings and improvements |
83,913 | 82,836 | ||||||
Equipment |
70,610 | 70,785 | ||||||
Office furniture and equipment |
9,188 | 9,077 | ||||||
Construction-in-progress |
7,083 | 3,958 | ||||||
Property, plant and equipment, gross |
$ | 174,463 | $ | 168,926 | ||||
Less: Accumulated depreciation |
(65,290 | ) | (62,646 | ) | ||||
Property, plant and equipment, net |
$ | 109,173 | $ | 106,280 | ||||
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8. ACCRUED EXPENSES, COMMITMENTS AND CONTINGENCIES
The following table sets forth the Companys accrued expenses:
March 31, | December 31 | |||||||
(in $000s) | 2011 | 2010 | ||||||
Payroll-related expenses |
$ | 11,179 | $ | 16,796 | ||||
Product returns |
30,275 | 33,755 | ||||||
Medicaid rebates |
10,812 | 12,475 | ||||||
Physician detailing sales force fees |
1,625 | 2,308 | ||||||
Legal and professional fees |
6,033 | 3,143 | ||||||
Shelf stock adjustments |
1,328 | 281 | ||||||
Other |
8,095 | 4,030 | ||||||
Total accrued expenses |
$ | 69,347 | $ | 72,788 | ||||
Product Returns
The Company maintains a product 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 Private Label, the Rx Partner, and the OTC Partners alliance agreements are
generally not subject to returns. A roll forward of the product return reserve for the three
months ended March 31, 2011 and the year ended December 31, 2010, is as follows:
March 31, | December 31, | |||||||
Product Return Reserve | 2011 | 2010 | ||||||
(in $000s) | ||||||||
Beginning balance |
$ | 33,755 | $ | 22,114 | ||||
Provision related to
sales recorded in the period |
2,706 | 15,821 | ||||||
Credits issued during the period |
(6,186 | ) | (4,180 | ) | ||||
Ending balance |
$ | 30,275 | $ | 33,755 | ||||
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, 2011, the Company had
remaining obligations under these contracts of approximately $1,023,000.
Purchase Order Commitments
As of March 31, 2011, the Company had approximately $22,558,000 of open purchase order
commitments, primarily for raw materials. The terms of these purchase order commitments are less
than one year in duration.
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9. 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 expected
effective tax rate and applies the estimated effective rate to its year-to-date taxable income or
loss. In addition, the effect of changes in enacted tax laws, rates, or tax status is recognized
in the interim period in which such change occurs.
The computation of the annual estimated effective tax rate 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 and temporary differences, and the likelihood of recovering deferred
tax assets. 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 rate includes modifications, which were projected
for the year, for share-based compensation, the domestic manufacturing deduction, and state
research and development credits, among others.
During the three months ended March 31, 2011, the Company recorded an aggregate tax provision
of $7,144,000 for United States domestic income taxes and for foreign income taxes. In the three
months ended March 31, 2010, the Company recorded an aggregate tax provision of $79,484,000 for
United States domestic income taxes and for foreign income taxes. The decrease in the tax
provision resulted from lower income before taxes in the three months ended March 31, 2011 as
compared to the same period in the prior year. The tax provision for the three months ended March
31, 2011 includes the effect of the federal research and development tax credit, enacted on
December 17, 2010 for a two-year period, retroactive to January 1, 2010. Conversely, the tax
provision for the three months ended March 31, 2010 does not include the effect of the federal
research and development tax credit which had expired on December 31, 2009.
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10. REVOLVING LINE OF CREDIT
On February 11, 2011, the Company entered into a Credit Agreement (the Credit Agreement)
with Wells Fargo Bank, National Association (Wells Fargo Bank), 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 Companys 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 Companys 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 Companys 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 Companys Total Net Leverage Ratio (as defined in the Credit Agreement), which is based upon the Companys 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 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, 2011, 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. |
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10. REVOLVING LINE OF CREDIT (continued)
| 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
Companys 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, National Association), 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, 2011 and 2010, unused line fees incurred under each
of the aforementioned respective credit agreements were $50,000 and $44,000, respectively.
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11. ALLIANCE AND COLLABORATION AGREEMENTS
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 Shires
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 $16,977,000 and $41,228,000 on sales of the AG Product during
the three months ended March 31, 2011 and 2010, respectively, with a corresponding charge included
in the cost of revenues line on the consolidated statement of operations.
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
Strategic Alliance Agreement with Teva
The following tables show the additions to and deductions from the deferred revenue and
deferred product manufacturing costs under the Teva Agreement:
Three Months | ||||||||
Ended | Inception | |||||||
(in $000s) | March 31, | Through | ||||||
Deferred revenue | 2011 | Dec 31, 2010 | ||||||
Beginning balance |
$ | 4,410 | $ | | ||||
Additions: |
||||||||
Product-related and cost sharing |
| 427,365 | ||||||
Exclusivity charges |
| (50,600 | ) | |||||
All other |
| 12,527 | ||||||
Total additions |
$ | | $ | 389,292 | ||||
Less: |
||||||||
Amount recognized |
(288 | ) | (188,442 | ) | ||||
Accounting adjustment |
| (196,440 | ) | |||||
Total deferred revenue |
$ | 4,122 | $ | 4,410 | ||||
Three Months | ||||||||
(in $000s) | Ended | Inception | ||||||
Deferred product | March 31, | Through | ||||||
manufacturing costs | 2011 | Dec 31, 2010 | ||||||
Beginning balance |
$ | | $ | | ||||
Additions |
| 182,981 | ||||||
Less: |
||||||||
Amount recognized |
| (87,555 | ) | |||||
Accounting adjustment |
| (95,426 | ) | |||||
Total deferred product
manufacturing costs |
$ | | $ | | ||||
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
OTC Partners Alliance Agreements
The following table shows the additions to and deductions from deferred revenue and deferred
product manufacturing costs under the OTC Agreements:
Three Months | ||||||||
Ended | Inception | |||||||
(in $000s) | March 31, | Through | ||||||
Deferred revenue | 2011 | Dec 31, 2010 | ||||||
Beginning balance |
$ | 11,382 | $ | | ||||
Additions: |
||||||||
Upfront fees and milestone
payments |
| 8,436 | ||||||
Cost-sharing and other |
| 1,642 | ||||||
Product-related deferrals |
910 | 87,934 | ||||||
Total additions |
$ | 910 | $ | 98,012 | ||||
Less: amount recognized |
(1,943 | ) | (86,630 | ) | ||||
Total deferred revenue |
$ | 10,349 | $ | 11,382 | ||||
Three Months | ||||||||
(in $000s) | Ended | Inception | ||||||
Deferred product | March 31, | Through | ||||||
manufacturing costs | 2011 | Dec 31, 2010 | ||||||
Beginning balance |
$ | 10,235 | $ | | ||||
Additions |
478 | 81,093 | ||||||
Less: amount recognized |
(1,357 | ) | (70,858 | ) | ||||
Total deferred product
manufacturing costs |
$ | 9,356 | $ | 10,235 | ||||
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
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 five dermatology products, including four of the Companys generic
products and one branded advanced form of Mediciss 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 received in December 2009, and a $3,000,000 milestone payment received
in March 2011. The Company has the potential to receive up to an additional $8,000,000 of
contingent milestone payments upon achievement of certain contractually specified clinical and
regulatory milestones, 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, if any, of such products.
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
License, Development and Commercialization Agreement & Supply Agreement with Glaxo Group
Limited
In December 2010, the Company entered into a License, Development and Commercialization
Agreement (License Agreement) and a related Supply Agreement with Glaxo Group Limited (GSK).
The License Agreement and the Supply Agreement are accounted for as a single contractual
arrangement under FASB ASC 605-25. Under the terms of the License Agreement, the Company granted
GSK exclusive development and commercial licenses to the Companys lead-branded-product candidate
known as IPX066, and certain follow-on products at the option of GSK, for all worldwide
jurisdictions, except those in the United States of America and Taiwan, R.O.C. Under the Supply
Agreement, the Company is required to manufacture IPX066 for GSKs use in its development and
commercial activities, for which GSK will pay a transfer price computed under the terms of the
Supply Agreement. Under the License Agreement, the Company received an initial $11,500,000 up-front
payment in December 2010 (the License Agreement up-front payment). The Company has the potential
to receive up to $175,000,000 of additional contingent payments upon the achievement of certain
specified development, clinical, regulatory, and /or commercialization milestones. The
consideration, including the License Agreement up-front payment, during the development period will
be deferred and recognized on a straight-line basis over the Companys expected period of
performance during the development period, which is currently estimated to be the 24 month period
ending December 31, 2012. The research and development milestone payments, if any, will be
accounted for according to FASB ASC 605-28, Milestone Method, wherein they will be recognized as
revenue in the period earned, provided the criteria of ASC 605-28 are met at the time of such
respective milestone payments. The Company may also receive royalty payments on any sales of IPX066
by GSK, which will be recognized as revenue in the period earned. Upon exercise of its option for
the follow-on product, GSK is required to pay a fee to the Company, of which the Company will defer
such payment and recognize revenue over the expected period of performance of the follow-on product
development period. The Company and GSK are each generally responsible for costs incurred to
complete their respective development activities, except in limited circumstances as specified in
the License Agreement. The License Agreement and Supply Agreement will continue until GSK no longer
has any royalty payment obligations to the Company, or if the License Agreement and Supply
Agreement are terminated earlier in accordance with their contractual terms. The License Agreement
and Supply 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 respective agreements.
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
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
Companys lead-branded-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 payments upon achievement of certain specified clinical and regulatory
milestones. 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
$10,000,000 up-front payment is being recognized as revenue on a straight-line basis over a period
of 91 months, which is the Companys estimated expected period of performance of the Endo Agreement
Product research and development activities, commencing with the June 2010 effective date of the
Endo Agreement and ending in December 2017, the estimated date of FDA approval of the Companys
NDA. The FDA approval of the Endo Agreement Product NDA represents the end of the Companys
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-alliance agreement. 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 Companys estimated expected period of performance. Upon FDA approval
of the Companys 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 the 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.
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11. ALLIANCE AND COLLABORATION AGREEMENTS (continued)
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,
effective April 1, 2010, the Company provides physician detailing sales call services for Pfizers
Lyrica® product to neurologists. Effective January 1, 2010, the Company receives a fixed fee,
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 Companys 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 and $3,503,000 in the three months ended March 31, 2011 and 2010,
respectively, under the Pfizer Co-Promotion Agreement, with such amounts presented in the line item
Promotional Partner revenue on the consolidated statement of operations.
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12. 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 Companys 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: | ||||||||
March 31, | March 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Manufacturing expenses |
$ | 515 | $ | 898 | ||||
Research and development |
953 | 898 | ||||||
Selling, general & administrative |
1,419 | 1,077 | ||||||
Total |
$ | 2,887 | $ | 2,873 | ||||
The following table summarizes stock option activity:
Weighted Average | ||||||||
Number of Shares | Exercise Price | |||||||
Under Option | per Share | |||||||
Outstanding at December 31, 2010 |
6,514,676 | $ | 10.84 | |||||
Options granted |
| $ | | |||||
Options exercised |
(738,660 | ) | $ | 11.19 | ||||
Options forfeited |
(74,413 | ) | $ | 9.45 | ||||
Outstanding at March 31, 2011 |
5,701,603 | $ | 10.82 | |||||
Vested and expected to vest at March 31, 2011 |
6,307,281 | $ | 10.70 | |||||
Options exercisable at March 31, 2011 |
3,358,091 | $ | 11.55 | |||||
The Company estimated the fair value of each stock option award on the grant date using the
Black-Scholes Merton option-pricing model, wherein: expected volatility is based solely on
historical volatility of the Companys 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 actual experience. The
risk-free interest rate is based on the U.S. Treasury yield in effect at the time 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 Companys non-vested restricted stock awards is presented below:
Weighted Average | ||||||||
Restricted | Number of Restricted | Grant-Date | ||||||
Stock Awards | Stock Awards | Fair Value | ||||||
Non-vested at December 31, 2010 |
1,434,759 | $ | 12.93 | |||||
Granted |
18,850 | $ | 20.60 | |||||
Vested |
(64,645 | ) | $ | 6.23 | ||||
Forfeited |
(55,231 | ) | $ | 14.30 | ||||
Non-vested at March 31, 2011 |
1,333,733 | $ | 13.39 | |||||
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 Companys 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.
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12. SHARE-BASED COMPENSATION (continued)
As of March 31, 2011, the Company had total unrecognized share-based compensation expense, net
of estimated forfeitures, of $24,637,000 related to all of its share-based awards, which will be
recognized over a weighted average period of 2.11 years. The intrinsic value of stock options
exercised during the three months ended March 31, 2011 and 2010 was $8,942,000 and $3,730,000,
respectively. The total fair value of restricted stock awards which vested during the three months
ended March 31, 2011 and 2010 was $403,000 and $910,000, respectively. As of March 31, 2011, the
Company had 2,810,345 shares of common stock available for issuance of stock options, restricted
stock awards or stock appreciation rights.
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13. 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 Companys common stock. During
the three months ended March 31, 2011 and 2010, the Company did not issue any preferred stock.
Common Stock
The Companys 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 Companys 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 Companys 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 Companys outstanding common stock are exchanged for securities of any other person, cash or
any other property, or more than 50% of the Companys 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
expire on January 20, 2012, unless extended by the Board of Directors. 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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14. EARNINGS PER SHARE
The companys 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
earnings 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
months ended March 31, 2011 and 2010 was as follows:
Three Months Ended: | ||||||||
March 31, | March 31, | |||||||
(in $000s except per share amounts) | 2011 | 2010 | ||||||
Numerator: |
||||||||
Net income |
$ | 13,863 | $ | 131,485 | ||||
Denominator: |
||||||||
Weighted average common
shares outstanding |
63,390,527 | 61,008,015 | ||||||
Effect of dilutive options and common
stock purchase warrants |
3,653,739 | 2,857,663 | ||||||
Diluted weighted average
common shares outstanding |
67,044,266 | 63,865,678 | ||||||
Basic net income per share |
$ | 0.22 | $ | 2.16 | ||||
Diluted net income per share |
$ | 0.21 | $ | 2.06 | ||||
For the three months ended March 31, 2011 and 2010, the Company excluded 687,482 and
1,034,741, respectively, of stock options from the computation of diluted net income per common
share as the effect of these options would have been anti-dilutive.
15. COMPREHENSIVE INCOME
Three Months Ended: | ||||||||
March 31, | March 31, | |||||||
(in $000s) | 2011 | 2010 | ||||||
Net income |
$ | 13,863 | $ | 131,485 | ||||
Currency translation adjustments |
(426 | ) | 347 | |||||
Comprehensive income |
13,437 | 131,832 | ||||||
Comprehensive income attributable to
the noncontrolling interest |
| | ||||||
Comprehensive income attributable
to Impax Laboratories, Inc. |
$ | 13,437 | $ | 131,832 | ||||
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16. SEGMENT INFORMATION
The Company has two reportable segments, the Global Pharmaceuticals Division (Global
Division) and the Impax Pharmaceuticals Division (Impax Division). The Company currently
markets and sells its Global Division products within the continental United States of America and
the Commonwealth of Puerto Rico.
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 and collaboration 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. 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 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 Companys chief operating decision maker evaluates the financial performance of the
Companys 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 Companys 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
Companys chief operating decision maker. The accounting policies for the Companys segments are
the same as those described above in the discussion of Revenue Recognition and in the Summary of
Significant Accounting Policies in the Companys Form 10-K for the year ended December 31, 2010.
The Company has no inter-segment revenue.
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16. SEGMENT INFORMATION (continued)
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 $000s) | Global | Impax | Corporate | Total | ||||||||||||
Three Months Ended March 31, 2011 | Division | Division | and Other | Company | ||||||||||||
Revenue, net |
$ | 103,348 | $ | 5,303 | $ | | $ | 108,651 | ||||||||
Cost of revenue |
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 |
(in $000s) | Global | Impax | Corporate | Total | ||||||||||||
Three Months Ended March 31, 2010 | Division | Division | and Other | Company | ||||||||||||
Revenue, net |
$ | 319,830 | $ | 3,503 | $ | | $ | 323,333 | ||||||||
Cost of revenue |
76,432 | 3,144 | | 79,576 | ||||||||||||
Research and development |
9,435 | 8,874 | | 18,309 | ||||||||||||
Patent Litigation |
1,984 | | | 1,984 | ||||||||||||
Income (loss) before provision for income taxes |
$ | 228,645 | $ | (9,324 | ) | $ | (8,324 | ) | $ | 210,997 |
Foreign Operations
The Companys 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 $39,250,000 of net
carrying value of assets, composed principally of a building and equipment, included in the
Companys consolidated balance sheet at March 31, 2011.
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17. 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 Abbreviated New Drug Application (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 holders 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, or 30 months from the date the notice was received, whichever is
sooner. Lawsuits have been filed against the Company in connection the Companys Paragraph IV
certifications.
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 Companys 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 Companys results of
operations and financial position. In addition, there can be no assurance 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.
Further, 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. For the six products with ANDAs already filed with the FDA at the time the Teva
Agreement was signed, Teva is required to pay 50% of the fees and costs in excess of $7,000,000;
for three of the products with ANDAs filed since the Teva Agreement was signed, Teva is required to
pay 45% of the fees and costs; and for the remaining three products, Teva is required to pay 50% of
the fees and costs. The Company is responsible for the remaining fees and costs relating to these
products.
The Company is generally responsible for all of the patent litigation fees and costs
associated with current and future products not covered by the Teva Agreement. The company has
agreed to share legal expenses under the terms of certain of the alliance and collaboration
agreements it has entered into. The Company records the costs of patent litigation as expense 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.
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17. LEGAL AND REGULATORY MATTERS (continued)
Patent Infringement Litigation
Aventis Pharmaceuticals Inc., et al. v. Impax Laboratories, Inc.
(Fexofenadine/Pseudoephedrine)
The Company is a defendant in an action brought in March 2002 by Aventis Pharmaceuticals Inc.
and others in the U.S. District Court for the District of New Jersey alleging the Companys
proposed Fexofenadine and Pseudoephedrine Hydrochloride tablets, generic to Allegra-D®, infringe
seven Aventis patents and seeking an injunction preventing the Company from marketing the products
until expiration of the patents. The case has since been consolidated with similar actions brought
by Aventis against five other manufacturers (including generics to both Allegra® and Allegra-D®).
In March 2004, Aventis and AMR Technology, Inc. filed a complaint and first amended complaint
against the Company and one of the other defendants alleging infringement of two additional
patents, owned by AMR and licensed to Aventis, relating to a synthetic process for making the
active pharmaceutical ingredient, Fexofenadine Hydrochloride and intermediates in the synthetic
process. The Company believes it has defenses to the claims based on non-infringement and
invalidity.
In June 2004, the court granted the Companys motion for summary judgment of non-infringement
with respect to two of the patents and, in May 2005, granted summary judgment of invalidity with
respect to a third patent. The Company will have the opportunity to file additional summary
judgment motions in the future and to assert both non-infringement and invalidity of the remaining
patents (if necessary) at trial. No trial date has yet been set. In September 2005, Teva
Pharmaceuticals, USA launched its Fexofenadine tablet products (generic to Allegra®), and Aventis
and AMR moved for a preliminary injunction to bar Tevas sales based on four of the patents in
suit, which patents are common to the Allegra® and Allegra-D® litigations. The district court
denied Aventiss motion in January 2006, finding Aventis did not establish a likelihood of success
on the merits, which decision was affirmed on appeal. Discovery is complete and summary judgment
motions have been filed. On March 29, 2011, the district court entered an Order of Dismissal based
upon the parties agreement on settlement terms, with the parties having the right to reopen the
case in the event a settlement is not consummated within 60 days.
Pfizer Inc., et aI. v. Impax Laboratories, Inc. (Tolterodine)
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 Companys filing of an ANDA relating to Tolterodine
Tartrate Extended Release Capsules, 4 mg, generic to Detrol® LA, infringes three Pfizer patents
(2008 Action). 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 Companys ANDA
amendment adding a 2mg strength. For one of the patents-in-suit, U.S. Patent No. 5,382,600,
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.). After the Pfizer court conducted a bench trial, it found the 600 patent not invalid on
January 20, 2010, and that decision is on appeal to the U.S. Court of Appeals for the Federal
Circuit. Discovery is proceeding in the Companys case, and no trial date has been set.
In December 2010, the Company filed a separate declaratory judgment action against Pfizer in
the U.S. District Court for the District of New Jersey, requesting the district court to declare
one of the patents-in-suit, U.S. Patent No. 6,911,217, listed in the FDAs publication Approved
Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book)
for Detrol LA® is invalid. Pfizer filed a motion to dismiss the declaratory action for lack of
subject matter jurisdiction or, alternatively, because the Companys sole claim should have been
brought as a compulsory counterclaim in the 2008 action. The parties are awaiting a decision on
Pfizers motion.
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17. LEGAL AND REGULATORY MATTERS (continued)
Eli Lilly and Company v. Impax Laboratories, Inc. (Duloxetine)
In November 2008, Eli Lilly and Company filed suit against the Company in the U.S. District
Court for the Southern District of Indiana, alleging patent infringement for the filing of the
Companys ANDA relating to Duloxetine Hydrochloride Delayed Release Capsules, 20 mg, 30 mg, and 60
mg, generic to Cymbalta®. In February 2009, the parties agreed to be bound by the final judgment
concerning infringement, validity and enforceability of the patent at issue in cases brought by Eli
Lilly against other generic drug manufacturers that have filed ANDAs relating to this product and
proceedings in this case were stayed. In March 2011, a stipulated final judgment of patent
infringement and validity was entered against Wockhardt Limited. On April 27, 2011, a stipulated
order was entered, enjoining Impax from selling or offering to sell its ANDA product before the
expiration of U.S. Patent No. 5,023,269 (the 269 patent) and requiring Impax to convert its
Paragraph IV Certification to a Paragraph III Certification with respect to the 269 patent.
Warner Chilcott, Ltd. et.al. v. Impax Laboratories, Inc. (Doxycycline Hyclate)
In December 2008, Warner Chilcott Limited 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 Companys 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 Companys ANDA for the 150 mg
strength. Markman briefing is completed, and discovery is proceeding. No trial date has been set.
Genzyme Corp. 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 Companys ANDA
relating to Sevelamer Hydrochloride Tablets, 400 mg and 800 mg, generic to Renagel®. The Company
has filed an answer and counterclaim. Discovery is proceeding, and trial is scheduled for
September 27, 2012.
Genzyme Corp. 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 Companys ANDA
relating to Sevelamer Carbonate Tablets, 800 mg, generic to Renvela®. The Company has filed an
answer and counterclaim. Discovery is proceeding, and trial is scheduled for September 27, 2012.
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17. LEGAL AND REGULATORY MATTERS (continued)
The Research Foundation of State University of New York 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 Companys ANDA relating to Doxycycline Monohydrate
Delayed-Release Capsules, 40 mg, generic to Oracea®. The Company filed an answer and counterclaim.
In October 2009, the parties agreed to be bound by the final judgment concerning infringement,
validity and enforceability of the patent at issue in cases brought by Galderma against another
generic drug manufacturer that has filed an ANDA relating to this product and proceedings in this
case were stayed. In June 2010, Galderma moved for a preliminary injunction to bar sales by the
other generic manufacturer based on two of the patents in suit, which motion was granted by the
magistrate judge in a decision finding Galderma had shown a likelihood of success on the merits.
Elan Pharma International Ltd. and Fournier Laboratories Ireland Ltd. v. Impax Laboratories,
Inc. Abbott Laboratories and Laboratoires Fournier S.A. v. Impax Laboratories, Inc.
(Fenofibrate)
In October 2009, Elan Pharma International Ltd. with Fournier Laboratories Ireland Ltd. and
Abbott Laboratories with Laboratories Fournier S.A. filed separate suits against the Company in the
U.S. District Court for the District of New Jersey alleging patent infringement for the filing of
the Companys ANDA relating to Fenofibrate Tablets, 48 mg and 145 mg, generic to Tricor®. The
Company has filed an answer and counterclaim. In September 2010, the district court vacated the
schedule and ordered a stay in the two matters related to the Company.
Daiichi Sankyo, Inc. et al. v. Impax Laboratories, Inc. (Colesevelam)
In January 2010, Daiichi Sankyo, Inc. and Genzyme Corporation (together, Genzyme) filed suit
against the Company in the U.S. District Court for the District of Delaware alleging patent
infringement for the filing of the Companys ANDA relating to Colesevelam Hydrochloride Tablets,
625 mg, generic to Welchol®. The Company has filed an answer and counterclaim. Fact discovery
closes July 29, 2011 and no trial date has been scheduled.
Abbott Laboratories, et al. v. Impax Laboratories, Inc. (Choline Fenofibrate)
In March 2010, Abbott Laboratories and Fournier Laboratories Ireland Ltd. (together, Abbott)
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 Companys ANDA related to Choline Fenofibrate Delayed
Release Capsules, 45 mg and 135 mg, generic of Trilipix®. The Company has filed an answer.
Discovery is proceeding, and no trial date has been scheduled.
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 Companys ANDA relating to Fenofibrate Tablets, 40 and 120 mg, generic to Fenoglide®. The
Company has filed its answer.
Genzyme Corp. 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 Companys ANDA
relating to Sevelamer Carbonate Powder, 2.4 g and 0.8 g packets, generic to Renvela® powder. The
Company has filed an answer and counterclaim. Discovery is proceeding, and trial is scheduled for
September 27, 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 alleging
patent infringement for the filing of the Companys ANDA relating to Ezetimibe/Simvastatin Tablets,
10/80 mg, generic to Vytorin ®. The Company has 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 this case were stayed.
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17. LEGAL AND REGULATORY MATTERS (continued)
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 Companys ANDA relating to Niacin-Simvastatin Tablets, 1000/20 mg, generic to
Simcor®. The Company has filed an answer and counterclaim.
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 Companys ANDA relating to Methylphenidate Hydrochloride
Tablets, 54 mg, generic to Concerta®. The Company has filed its answer. In March 2011, the case was
stayed until the earlier of six months from the stay date, or, the date the district court issues
an opinion on the motion for summary judgment of patent invalidity filed in Alza Corp. v. Kremers
Urban, LLC, Case No. 10-00023 (D. Del.).
Daiichi Sankyo, Inc. et al. v. Impax Laboratories, Inc. (Colesevelam Powder) |
In November 2010, Daiichi Sankyo, Inc. and Genzyme Corporation (together, Daiichi) filed
suit against the Company in the U.S. District Court for the District of Delaware alleging patent
infringement for the filing of the Companys ANDA relating to Colesevelam Hydrochloride Powder,
1.875 gm/packet and 3.75 gm/packet, generic to Welchol® for Oral Suspension. The Company has filed
an answer and counterclaim. Fact discovery closes July 29, 2011 and no trial date has been
scheduled.
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 Companys 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.
The Company has filed its answer and counterclaims.
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 for the filing of the Companys ANDA relating to Dexlansoprazole
Delayed Release Capsules, 30 and 60 mg, generic to Dexilant®.
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 Companys ANDA
relating to Oxycodone Hydrochloride, Controlled Release tablets, 10, 15, 20, 30, 40, 60 and 80 mg,
generic to Oxycontin®.
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Other Litigation Related to the Companys 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 have been removed to federal court, and a petition for
multidistrict litigation to consolidate the cases in federal court has been 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 have filed a motion for class certification and the Company has filed an opposition to
that motion. The class certification hearing is set for May 17, 2011, and expert discovery closes
on May 27, 2011. No trial date has been scheduled.
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 Shires failure to fill the Companys 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 has filed a motion for a
preliminary injunction and a temporary restraining order seeking to require Shire to fill product
orders placed by the Company. 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 proceeding and no trial
date has been scheduled.
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18. SUPPLEMENTARY FINANCIAL INFORMATION (unaudited)
Selected (unaudited) financial information for the quarterly period noted is as follows:
Quarter Ended: | ||||
(in $000s except per share amounts) | March 31, 2011 | |||
Revenue: |
||||
Global Product sales, gross |
$ | 151,440 | ||
Less: |
||||
Chargebacks |
35,216 | |||
Rebates |
12,709 | |||
Product Returns |
2,706 | |||
Other credits |
8,863 | |||
Global Product sales, net |
91,946 | |||
Private Label Product sales |
392 | |||
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 (unaudited) 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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18. SUPPLEMENTARY FINANCIAL INFORMATION (unaudited) (continued)
Selected (unaudited) financial information for the quarterly period noted is as follows:
Quarter Ended: | ||||
(in $000s except per share amounts) | March 31, 2010 | |||
Revenue: |
||||
Global Product sales, gross |
$ | 425,986 | ||
Less: |
||||
Chargebacks |
56,168 | |||
Rebates |
29,425 | |||
Product Returns |
7,400 | |||
Other credits |
23,888 | |||
Global Product sales, net |
309,105 | |||
Private Label Product sales |
672 | |||
Rx Partner |
4,903 | |||
OTC Partner |
1,765 | |||
Research Partner |
3,385 | |||
Promotional Partner |
3,503 | |||
Total revenues |
323,333 | |||
Gross profit |
243,757 | |||
Net income |
$ | 131,485 | ||
Net income per share (basic) |
$ | 2.16 | ||
Net income per share (diluted) |
$ | 2.06 | ||
Weighted Average: |
||||
common shares outstanding: |
||||
Basic |
61,008,015 | |||
Diluted |
63,865,678 | |||
Quarterly computations of (unaudited) 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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ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion and analysis, as well as other sections in this Quarterly Report on
Form 10-Q, should be read in conjunction with the unaudited interim consolidated financial
statements and related notes to the unaudited interim consolidated financial statements included
elsewhere herein.
Statements included in this Quarterly Report on Form 10-Q not related to present or historical
conditions are forward-looking statements. Additional oral or written forward-looking statements
may be made by us from time to time. Such forward-looking statements involve risks and
uncertainties which could cause results or outcomes to differ materially from those expressed in
the forward-looking statements. Forward-looking statements may include statements relating to our
plans, strategies, objectives, expectations and intentions. Words such as believes, forecasts,
intends, possible, estimates, anticipates, and plans and similar expressions are intended
to identify forward-looking statements. Our ability to predict results or the effect of events on
our operating results is inherently uncertain. Forward-looking statements involve a number of
risks, uncertainties and other factors that could cause actual results to differ materially from
those discussed in this Quarterly Report on Form 10-Q. Such risks and uncertainties include the
effect of current economic conditions on our industry, business, financial position and results of
operations, our ability to maintain an effective system of internal control over financial
reporting, fluctuations in our revenues and operating income, our ability to successfully develop
and commercialize pharmaceutical products, reductions or loss of business with any significant
customer or a reduction in sales of any significant product, the impact of competition, our ability
to sustain profitability and positive cash flows, any delays or unanticipated expenses in
connection with the operation of our Taiwan facility, the effect of foreign economic, political,
legal and other risks on our operations abroad, the uncertainty of patent litigation, consumer
acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug
Administration filings and approvals, our inexperience in conducting clinical trials and submitting
new drug applications, our ability to successfully conduct clinical trials, our reliance on
alliance and collaboration agreements, the availability of raw materials, our ability to comply
with legal and regulatory requirements, the regulatory environment, our ability to protect our
intellectual property, exposure to product liability claims and other risks described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2010. You should not place undue
reliance on forward-looking statements. Such statements speak only as to the date on which they are
made, and we undertake no obligation to update publicly or revise any forward-looking statement,
regardless of future developments or availability of new information.
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Overview
We are a technology based, specialty pharmaceutical company applying formulation and
development expertise, as well as our drug delivery technology, to the development, manufacture and
marketing of controlled-release and niche generics, in addition to the development of branded
products. As of May 2, 2011, we marketed 101 generic pharmaceuticals, which represent dosage
variations of 29 different pharmaceutical compounds through our own Global Pharmaceuticals
division; another 16 of our generic pharmaceuticals representing dosage variations of 4 different
pharmaceutical compounds are marketed by our alliance and collaboration agreement partners. We have
39 applications pending at the FDA, including 2 tentatively approved by the FDA, and 77 other
products in various stages of development for which applications have not yet been filed.
In the generic pharmaceuticals market, we focus our efforts on controlled-release generic
versions of selected brand-name pharmaceuticals covering a broad range of therapeutic areas and
having technically challenging drug-delivery mechanisms or limited competition. We employ our
technologies and formulation expertise to develop generic products that will reproduce the
brand-name products physiological characteristics but not infringe any valid patents relating to
the brand-name product. We generally focus on brand-name products as to which the patents covering
the active pharmaceutical ingredient have expired or are near expiration, and we employ our
proprietary formulation expertise to develop controlled-release technologies that do not infringe
patents covering the brand-name products controlled-release technologies.
We are also developing specialty generic pharmaceuticals that we believe present one or more
barriers to entry by competitors, such as difficulty in raw materials sourcing, complex formulation
or development characteristics or special handling requirements. In the brand-name pharmaceuticals
market, we are developing products for the treatment of central nervous system (CNS) disorders.
Our brand-name product portfolio consists of development-stage projects to which we are applying
our formulation and development expertise to develop differentiated, modified, or
controlled-release versions of currently marketed (either in the U.S. or outside the U.S.) drug
substances. We intend to expand our brand-name products portfolio primarily through internal
development and also through licensing and acquisition.
We operate in two segments, referred to as the Global Pharmaceuticals Division or Global
Division and the Impax Pharmaceuticals Division or 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 we sell directly to wholesalers, large retail drug chains, and
others; the Private Label sales channel, for generic pharmaceutical over-the-counter (OTC) and
prescription products we sell 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 and collaboration agreements; and the OTC Partner sales channel, for sales of generic
pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities under their
own label pursuant to alliance and collaboration agreements. We sell our Global Division products
within the continental United States of America and the Commonwealth of Puerto Rico. We have no
sales in foreign countries. We also generate revenue from research and development services
provided under a joint development agreement with another pharmaceutical company, and report such
revenue under the caption Research partner revenue on the consolidated statement of operations.
We provide theses services through the research and development group in our Global Division.
The Impax Division is engaged in the development of proprietary brand pharmaceutical products
through improvements to already approved pharmaceutical products to address CNS disorders. The
Impax Division is also engaged in the co-promotion of products developed by unrelated third-party
pharmaceutical entities through our direct sales force focused on marketing to physicians (referred
to as physician detailing sales calls) in the CNS community. We also generate revenue in the
Impax Division from research and development services provided under a development and license
agreement with an unrelated third-party pharmaceutical company, and report such revenue under the
caption Research Partner revenue on the consolidated statement of operations.
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We have entered into several alliance, collaboration or license and distribution agreements
with respect to certain of our products and services and may enter into similar agreements in the
future. These agreements may require us to relinquish rights to certain of our technologies or
product candidates, or to grant licenses on terms which ultimately may prove to be unfavorable to
us. Relationships with alliance and collaboration partners may also include risks due to the
failure of a partner to perform under the agreement, incomplete marketplace information,
inventories, development capabilities, regulatory compliance and commercial strategies of our
partners and our agreements may be the subject of contractual disputes. If we, or our partners, are
not successful in commercializing the products covered by the agreements, such commercial failure
could adversely affect our business.
Pursuant to a license and distribution agreement, we are dependent on an unrelated third-party
pharmaceutical company to supply us with our authorized generic Adderall XR®, which we market and
sell. We experienced disruptions related to the supply of our authorized generic Adderall XR® under
the license and distribution agreement during the three months ended March 31, 2011 and the fiscal
year ended December 31, 2010. In November 2010, we filed suit against the third party supplier of
our authorized generic of Adderall XR® for breach of contract and other related claims due to a
failure to fill our orders as required by the license and distribution agreement. In addition, we
have filed a motion for a preliminary injunction and a temporary restraining order seeking to
require the third party supplier to fill product orders placed by us. If we suffer supply
disruptions related to our authorized generic Adderall XR® product in the future, our revenues and
relationships with our customers may be materially adversely affected. Further, we may enter into
similar license and distribution agreements in the future. Any delay or interruption in the supply
of product under such agreements could curtail or delay our product shipments and adversely affect
our revenues, as well as jeopardize our relationships with customers.
Impact of Economic and Regulatory Conditions
The global economy has undergone a period of significant volatility which has lead to
diminished credit availability, declines in consumer confidence, and increases in unemployment
rates. There remains caution about the stability of the U.S. economy due to the global financial
crisis, and there can be no assurances further deterioration in the financial markets will not
occur. These economic conditions have resulted in, and could lead to further, reduced consumer
spending related to healthcare in general and pharmaceutical products in particular. In addition,
we have exposure to many different industries and counterparties, including our partners under our
alliance and collaboration agreements, suppliers of raw chemical materials, drug wholesalers and
other customers that may be affected by an unstable economic environment. Any economic instability
may affect these parties ability to fulfill their respective contractual obligations to us or
cause them to limit or place burdensome conditions upon future transactions with us which could
adversely affect our business, financial position and results of operations. Healthcare costs have
risen significantly over the past decade. There have been, and continue to be, new and proposed
healthcare regulations, including the Healthcare Reform Law, to reduce healthcare spending and
contain costs. Certain reform initiatives may impose significant new regulations that limit prices
on currently marketed products and future products currently under development, or require us to
agree to provide product rebates on certain items to government payers, which may be significant.
These limitations could, in turn, reduce the amount of revenues we will be able to ultimately earn
in the future from sales of our products and services.
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Critical Accounting Estimates
The preparation of our consolidated financial statements in conformity with accounting
principles generally accepted in the United States (GAAP) and the rules and regulations of the U.S.
Securities and Exchange Commission (SEC) require the use of estimates and assumptions, based on
complex judgments considered reasonable, and 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 Companys 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 manufacturing costs under the Companys several alliance and collaboration
agreements. Actual results may differ from estimated results.
Although we believe our estimates and assumptions are reasonable when made, they are based
upon information available to us at the time they are made. We periodically review the factors
having an influence on our estimates and, if necessary, adjust such estimates. Although
historically our estimates have generally been reasonably accurate, due to the risks and
uncertainties involved in our business and evolving market conditions, and given the subjective
element of the estimates made, actual results may differ from estimated results. This possibility
may be greater than normal during times of pronounced economic volatility.
Global Product sales, net. We recognize revenue from direct sales in accordance with SEC
Staff Accounting Bulletin No. 104, Topic 13 Revenue Recognition (SAB 104). Revenue from direct
product sales is recognized at the time title and risk of loss pass to customers. Accrued
provisions for estimated chargebacks, rebates, product returns, and other pricing adjustments are
provided for in the period the related sales are recorded.
Consistent with industry practice, we record an accrued provision for estimated deductions for
chargebacks, rebates, product returns, Medicare, Medicaid, and other government rebate programs,
shelf-stock adjustments, and other pricing adjustments, in the same period when revenue is
recognized. The objective of recording provisions for such deductions at the time of sale is to
provide a reasonable estimate of the aggregate amount we expect to ultimately credit our customers.
Since arrangements giving rise to the various sales credits are typically time driven (i.e.
particular promotions entitling customers who make purchases of our products during a specific
period of time, to certain levels of rebates or chargebacks), these deductions represent important
reductions of the amounts those customers would otherwise owe us for their purchases of those
products. Customers typically process their claims for deductions in a reasonably timely manner,
usually within the established payment terms. We monitor actual credit memos issued to our
customers and compare such actual amounts to the estimated provisions, in the aggregate, for each
deduction category to assess the reasonableness of the various reserves at each quarterly balance
sheet date. Differences between our estimated provisions and actual credits issued have not been
significant, and are accounted for in the current period as a change in estimate in accordance with
GAAP. We do not have the ability to specifically link any particular sales credit to an exact sales
transaction and since there have been no material differences, we believe our systems and
procedures are adequate for managing our business. An event such as the failure to report a
particular promotion could result in a significant difference between the estimated amount accrued
and the actual amount claimed by the customer, and, while there have been none to date, we would
evaluate the particular events and factors giving rise to any such significant difference in
determining the appropriate accounting.
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Chargebacks. We have agreements establishing contract prices for certain products with
certain indirect customers, such as managed care organizations, hospitals, and government agencies
who purchase our products from drug wholesalers. The contract prices are lower than the prices the
customer would otherwise pay to the wholesaler, and the difference is referred to as a chargeback,
which generally takes the form of a credit memo issued by us to reduce the gross sales amount we
invoiced to our wholesaler customer. An accrued provision for chargeback deductions is estimated
and recorded at the time we ship the products to our wholesaler customers. The primary factors we
consider when estimating the accrued provision for chargebacks are the average historical
chargeback credits given, the mix of products shipped, and the amount of inventory on hand at the
three major drug wholesalers with whom we do business. We monitor aggregate actual chargebacks
granted and compare them to the estimated accrued provision for chargebacks to assess the
reasonableness of the chargeback reserve at each quarterly balance sheet date. The following table
is a roll-forward of the activity in the chargeback reserve for the three months ended March 31,
2011 and the year ended December 31, 2010:
March 31, | December 31 | |||||||
2011 | 2010 | |||||||
($in 000s) | ||||||||
Chargeback reserve |
||||||||
Beginning balance |
$ | 14,918 | $ | 21,448 | ||||
Provision recorded during the period |
35,216 | 181,566 | ||||||
Credits issued during the period |
(40,391 | ) | (188,096 | ) | ||||
Ending balance |
$ | 9,743 | $ | 14,918 | ||||
Provision as a percent of gross Global Product sales |
23 | % | 19 | % | ||||
The increase in the accrued provision for estimated chargebacks as a percent of gross Global
Product sales, resulted principally from lower sales and higher average chargebacks related to our
tamsulosin product, resulting in higher overall aggregate average chargebacks as a percentage of
gross Global Product sales in the three months ended March 31, 2011. In this regard, our
tamsulosin product generally resulted in higher aggregate gross Global Product sales and generally
carried a lower average chargeback credit amount in the prior year period during a contractual
market exclusivity period upon the products initial market launch. We commenced sales of our
tamsulosin product on March 2, 2010 and had contractual market exclusivity for this generic product
for the succeeding eight weeks, during which we were able to achieve high market-share penetration.
However, sales of our tamsulosin product have decreased significantly since the expiration of the
2010 contractual market exclusivity period as additional competing generic versions of the product
entered the market beginning in late April 2010, and have resulted in both price erosion and
reduction of our market-share.
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Rebates. In an effort to maintain a competitive position in the marketplace and to promote
sales and customer loyalty, we maintain various rebate programs with our customers to whom we
market our products through our Global Division Global Products sales channel. The rebates
generally take the form of a credit memo to reduce the invoiced gross sales amount charged to a
customer for products shipped. An accrued provision for rebate deductions is estimated and recorded
at the time of product shipment. The primary factors we consider 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 Global Product sales,
gross, 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 three major drug wholesalers with which we do
business. We also monitor aggregate actual rebates granted and compare them to the estimated
aggregate provision for rebates to assess the reasonableness of the aggregate rebate reserve at
each quarterly balance sheet date. The following table is a roll-forward of the activity in the
rebate reserve for the three months ended March 31, 2011 and the year ended December 31, 2010:
March 31, | December 31 | |||||||
2011 | 2010 | |||||||
($in 000s) | ||||||||
Rebate reserve |
||||||||
Beginning balance |
$ | 20,892 | $ | 37,781 | ||||
Provision recorded during the period |
12,709 | 91,064 | ||||||
Credits issued during the period |
(17,427 | ) | (107,953 | ) | ||||
Ending balance |
$ | 16,174 | $ | 20,892 | ||||
Provision as a percent of gross Global Product sales |
8 | % | 9 | % | ||||
As noted above, the change in the provision for rebates, as a percent of gross Global Product
sales, remained consistent period-over-period.
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Returns. We allow our customers to return product (i) if approved by authorized personnel in
writing or by telephone with the lot number and expiration date accompanying any request and (ii)
if such products are returned within six months prior to, or until twelve months following, the
products expiration date. We estimate a 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 return rates, adjusted by estimates of the future
return rates based on various assumptions, which may include 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. We also consider other factors, including
significant market changes which may impact future expected returns, and actual product returns.
We monitor aggregate actual product returns on a quarterly basis and we may record specific
provisions for product returns we believe are not covered by historical percentages. The following
table is a roll-forward of the activity in the product returns reserve for three months ended March
31, 2011 and the year ended December 31, 2010:
March 31, | December 31 | |||||||
2011 | 2010 | |||||||
($in 000s) | ||||||||
Product Returns Reserve |
||||||||
Beginning balance |
$ | 33,755 | $ | 22,114 | ||||
Provision related to
sales recorded in the period |
2,706 | 15,821 | ||||||
Credits issued during the period |
(6,186 | ) | (4,180 | ) | ||||
Ending balance |
$ | 30,275 | $ | 33,755 | ||||
Provision as a percent of gross Global Product sales |
1.8 | % | 1.6 | % | ||||
As noted above, the change in the provision for returns, as a percent of gross Global Product
sales, remained consistent period-over-period.
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Medicaid Rebate. As required by law, we provide a rebate payment on drugs dispensed under the
Medicaid program. We determine our estimate of the accrued Medicaid rebate reserve primarily based
on historical experience of claims submitted by the various states and any new information
regarding changes in the Medicaid program which may impact our estimate of Medicaid rebates. In
determining the appropriate accrual amount, we consider historical payment rates and processing lag
for outstanding claims and payments. We record estimates for Medicaid payments as a deduction from
gross sales, with corresponding adjustments to accrued liabilities. The accrual for Medicaid
payments totaled $10,812,000 and $12,475,000 as of March 31, 2011 and December 31, 2010,
respectively. The accrual for Medicaid rebate payments increased significantly beginning in 2009
as a result of the launch of our authorized generic Adderall XR® products in October 2009; which
require such Medicaid rebate payments to be calculated under the regulations applicable to brand
products.
Shelf-Stock Adjustments. Based upon competitive market conditions, we may reduce the selling
price of certain products. We 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 sales 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 us in response to market
conditions, including estimated launch dates of competing products and estimated declines in market
price. The accrued reserve for shelf-stock adjustments totaled $1,328,000 and $281,000 as of March
31, 2011 and December 31, 2010, respectively. Historically, differences between our estimated and
actual credits issued for shelf stock adjustments have not been significant.
Allowance for Uncollectible Amounts. We maintain allowances for uncollectible amounts for
estimated losses resulting from amounts deemed to be uncollectible from our customers; these
allowances are for specific amounts on certain accounts. The allowance for uncollectible amounts
totaled $599,000 and $539,000 at March 31, 2011 and December 31, 2010, respectively.
Private Label Sales. We recognize revenue from direct sales in accordance with SAB 104.
Revenue from direct product sales is recognized at the time title and risk of loss pass to
customers. Revenue received from Private Label product sales are generally not subject to
deductions for chargebacks, rebates, product returns, and other pricing adjustments. Additionally,
Private Label product sales do not have upfront, milestone, or lump-sum payments and do not contain
multiple deliverables under Financial Accounting Standards Board (FASB) Accounting Standards
Codification TM (ASC or the Codification) Topic 605.
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Rx Partner and OTC Partner. Each of our alliance and collaboration agreements involves
multiple deliverables in the form of products, services and/or licenses over extended periods. FASB
ASC Topic 605-25 supplemented SAB 104 for accounting for such multiple-element revenue
arrangements. With respect to our multiple-element revenue arrangements, we determine whether any
or all of the elements of the arrangement should be separated into individual units of accounting
under FASB ASC Topic 605-25. If separation into individual units of accounting is appropriate, we
recognize revenue for each deliverable when the revenue recognition criteria specified by SAB 104
are achieved for the deliverable. If separation is not appropriate, we recognize revenue (and
related direct manufacturing costs) over the estimated life of the agreement or the Companys
estimated expected period of performance using either the straight-line method or a modified
proportional performance method. Under the modified proportional performance method, the amount
recognized in the period of initial recognition is based upon the number of years elapsed under the
agreement relative to the estimated total recognition period of the particular agreement. The
amount of revenue recognized in the year of initial recognition is thus determined by multiplying
the total amount realized by a fraction, the numerator of which is the then current year of the
agreement and the denominator of which is the total number of years estimated to be the recognition
period. The remaining balance of the amount realized is then recognized in equal amounts in each
of the succeeding years of the recognition period. Thus, for example, with respect to profit share
or royalty payments reported by an alliance and collaboration agreement partner during the third
year of an agreement with an estimated recognition period of 15 years, 3 / 15 of the amount
reported is recognized in the year reported and 1/15 of the amount is recognized during each of the
remaining 12 years.
OTC Partner revenue is related to our alliance and collaboration agreements with Merck & Co.,
Inc. (formerly Schering-Plough Corporation) and Pfizer Inc. (formerly Wyeth) with respect to supply
of over-the-counter pharmaceutical products and related research and development services. We
initially defer all revenue earned under our OTC Partner alliance and collaboration agreements. The
deferred revenue is recorded as a liability captioned Deferred revenue alliance and
collaboration agreements. We also defer direct product manufacturing costs to the extent such
costs are reimbursable by the OTC Partners. These deferred product manufacturing costs are recorded
as an asset captioned Deferred product manufacturing costs alliance and collaboration
agreements. The product manufacturing costs in excess of amounts reimbursable by the OTC Partners
are recognized as current period cost of revenue. We recognize revenue as OTC Partner revenue and
amortize deferred product manufacturing costs as cost of revenues as we fulfill our contractual
obligations. Revenue is recognized and associated costs are amortized over the respective alliance
and collaboration agreements term of the arrangement or our expected period of performance, using
a modified proportional performance method. Under the modified proportional performance method of
revenue recognition utilized by us, the amount recognized in the period of initial recognition is
based upon the number of years elapsed under the respective 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 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 each respective alliance agreement.
As noted above, our alliance and collaboration agreements obligate us 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. In exchange for these deliverables, we receive payments from our alliance and
collaboration agreement partners for product shipments, and may also receive royalty, profit
sharing, and /or upfront or periodic milestone payments. Revenue received from the alliance and
collaboration agreement partners for product shipments under these agreements is generally not
subject to deductions for chargebacks, rebates, returns, shelf-stock adjustments, and other pricing
adjustments. Royalty and profit sharing amounts we receive under these agreements are calculated
by the respective alliance and collaboration 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, returns, shelf stock adjustments and other adjustments the
alliance agreement partners may negotiate with their customers. We record the alliance and
collaboration agreement partners adjustments to such estimated amounts in the period the alliance
and collaboration agreement partner reports the amounts to us.
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Research Partner. We have entered into development agreements with unrelated third-party
pharmaceutical companies under which we are collaborating in the development of five dermatological
products, including four generic products and one branded dermatological product, and one branded
CNS product. Under each of the development agreements, we received an upfront fee with the
potential to receive additional milestone payments upon completion of contractually specified
clinical and regulatory milestones. Additionally, we may also receive royalty payments from the
sale, if any, of a successfully developed and commercialized branded product under one of the
development agreements. Revenue received from the provision of research and development services,
including the upfront payment and the milestone payments received before January 1, 2011 are
deferred and recognized on a straight line basis over the expected period of performance of the
research and development services. Revenue received from the achievement of contingent research
and development milestones, if any, after January 1, 2011 will be recognized currently in the
period such payment is earned. Royalty fee income, if any, will be recognized by us as current
period revenue when earned.
Promotional Partner. We have entered into a promotional services agreement with an unrelated
third-party pharmaceutical company under which we provide physician detailing sales calls services
to promote certain of that companys branded drug products. We receive service fee revenue in
exchange for providing this service. We recognize revenue from the provision of physician
detailing sales calls as such services are rendered and the performance obligations are met and
from contingent payments, if any, at the time they are earned.
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Estimated Lives of Alliance and Collaboration Agreements. The revenue we receive under our
alliance agreements is not subject to adjustment for estimated chargebacks, rebates, product
returns and other pricing adjustments as such adjustments are included in the amounts we receive
from our alliance partners. However, because we recognize revenue we receive under our alliance
agreements, which is required to be deferred, over the estimated life of the related agreement or
our expected performance utilizing either the straight-line method or a modified proportional
performance method, we are required to estimate the recognition period under each such agreement in
order to determine the amount of revenue to be recognized in the current period. Sometimes this
estimate is based solely on the fixed term of the particular alliance agreement. In other cases the
estimate may be based on more subjective factors as noted in the following paragraphs. While
changes to the estimated recognition periods have been infrequent, such changes, should they occur,
may have a significant impact on our financial statements.
As an illustration, the consideration received from the provision of research and development
services under the License, Development and Commercialization Agreement with Glaxo Group Limited
(GSK), including the up-front fee and payments received for manufacturing clinical supplies, will
be initially deferred and then recognized on a straight-line basis over our expected period of
performance during the development period, which is currently estimated to be the 24 month period
ending December 31, 2012. If the expected period of performance is different from our estimate,
then the revenue recognition period will be adjusted on a prospective basis. In this regard, if we
were to estimate our period of performance to require significantly more time, then the License,
Development and Commercialization Agreement revenue recognition period would be increased on a
prospective basis, resulting in a reduced periodic amount of revenue recognized in current and
future periods.
Additionally, for example, the consideration received from the provision of research and
development services under the Joint Development Agreement with Medicis, including the up-front fee
and milestone payments received before January 1, 2011, have been initially deferred and are being
recognized on a straight-line basis over our expected period of performance to provide research and
development services under the Joint Development Agreement which is estimated to be a 48 month
period, starting in December 2008 (upon receipt of the $40.0 million upfront payment) and ending in
November 2012 (upon estimated FDA approval of the fifth and final submission). The FDA approval of
the final submission under the Joint Development Agreement represents the end of our estimated
expected period of performance, as we will have no further contractual obligation to perform
research and development services under the Joint Development Agreement, and therefore the earnings
process will be complete. If the timing of FDA approval for the final submission under the Joint
Development Agreement is different from our estimate, the revenue recognition period will change on
a prospective basis at the time such event occurs. While no such change in the estimated life of
the Medicis Joint Development Agreement has occurred to date, if we were to conclude significantly
more time will be required to obtain FDA approval, then we would increase our estimate of the
revenue recognition period under the Joint Development Agreement, resulting in a reduced periodic
amount of revenue recognized in current and future periods.
Additionally, for example, we estimate our expected period of performance to provide research
and development services under our Development and Co-Promotion Agreement with Endo
Pharmaceuticals, Inc. (Endo Agreement) is 91 months commencing in June 2010 (when the performance
of the contractual services commenced) and ending in December 2017 (the estimated date of FDA
approval of the product to be developed under the Endo Agreement). The FDA approval of the product
which is the subject of the Endo Agreement represents the end of our expected period of
performance, as we will have no further contractual obligation to perform research and development
activities under the Endo Agreement, and therefore the earnings process will be completed. If the
timing of FDA approval for the final submission under the Endo Agreement is different from our
estimate, the revenue recognition period will change on a prospective basis at the time such event
occurs. While no such change in the estimated life of the Endo Agreement has occurred to date, if
we were to conclude significantly more time will be required to obtain FDA approval of the product
to be developed under the Endo Agreement, then we would increase our estimate of the recognition
period under the agreement, resulting in a reduced periodic amount of revenue recognized in current
and future periods.
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Third-Party Research and Development Agreements. In addition to our own research and
development resources, we may use unrelated third-party vendors, including universities and
independent research companies, to assist in our research and development activities. These
vendors provide a range of research and development services to us, including clinical and
bio-equivalency studies. We generally sign agreements with these vendors which establish the terms
of each study performed by them, including, among other things, the technical specifications of the
study, the payment schedule, and timing of work to be performed. Payments are generally earned by
third-party researchers either upon the achievement of a milestone, or on a pre-determined date, as
specified in each study agreement. We account for third-party research and development expenses as
they are incurred according to the terms and conditions of the respective agreement for each study
performed, with an accrued expense at each balance sheet date for estimated fees and charges
incurred by us, but not yet billed to us. We monitor aggregate actual payments and compare them to
the estimated provisions to assess the reasonableness of the accrued expense balance at each
quarterly balance sheet date. Differences between our estimated and actual payments made have not
been significant.
Share-Based Compensation. We recognize the grant date fair value of each option and restricted share
over its vesting period. Options and restricted shares granted under the 2002 Plan vest over a
three or four year period and have a term of ten years. We estimate the fair value of each stock
option award on the grant date using the Black-Scholes Merton option-pricing model, wherein:
expected volatility is based on historical volatility of our common stock, and of a peer group for
the period of time our common stock was deregistered, 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
simplified method provides a reasonable estimate in comparison to our actual experience. The
risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for an
instrument with a maturity that is commensurate with the expected term of the stock options. The
dividend yield is zero as we have never paid cash dividends on our common stock, and have no
present intention to pay cash dividends.
Income Taxes. We are subject to U.S. federal, state and local income taxes and Taiwan R.O.C.
income taxes. We create a deferred tax asset, or a deferred tax liability, when we have temporary
differences between the financial statement carrying values (GAAP) and the tax bases of the
Companys assets and liabilities.
Fair Value of Financial Instruments. Our cash and cash equivalents include a portfolio of
high-quality credit securities, including U.S. Government sponsored entity securities, treasury
bills, corporate bonds, short-term commercial paper, and /or high rated money market funds. Our
entire portfolio matures in less than one year. The carrying value of the portfolio approximated
the market value at March 31, 2011. Our deferred compensation liability is carried at fair value,
based upon observable market values. We had no debt outstanding as of March 31, 2011. Our only
remaining debt instrument at March 31, 2011 was our credit facility with Wells Fargo Bank, N.A.,
which would be subject to variable interest rates and principal payments should we decide to borrow
against it.
Contingencies. In the normal course of business, we are subject to loss contingencies, such
as legal proceedings and claims arising out of our business, covering a wide range of matters,
including, among others, patent litigation, shareholder lawsuits, and product and clinical trial
liability. In accordance with FASB ASC Topic 450 Contingencies, we record accrued loss
contingencies when it is probable a liability will be incurred and the amount of loss can be
reasonably estimated and we do not recognize gain contingencies until realized.
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Goodwill In accordance with FASB ASC Topic 350, Goodwill and Other Intangibles, rather
than recording periodic amortization of goodwill, goodwill is subject to an annual assessment for
impairment by applying a fair-value-based test. Under FASB ASC Topic 350, if the fair value of the
reporting unit exceeds the reporting units carrying value, including goodwill, then goodwill is
considered not impaired, making further analysis not required. We consider each of our Global
Division and Impax Division operating segments to be a reporting unit, as this is the lowest level
for each of which discrete financial information is available. We attribute the entire carrying
amount of goodwill to the Global Division. We concluded the carrying value of goodwill was not
impaired as of December 31, 2010, as the fair value of the Global Division exceeded its carrying
value. We perform our annual goodwill impairment test in the fourth quarter of each year. We
estimate the fair value of the Global Division using a discounted cash flow model for both the
reporting unit and the enterprise, as well as earnings and revenue multiples per common share
outstanding for enterprise fair value. In addition, on a quarterly basis, we perform a review of
our business operations to determine whether events or changes in circumstances have occurred that
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. If such events or changes in
circumstances were deemed to have occurred, we would perform an interim impairment analysis, which
may include the preparation of a discounted cash flow model, or consultation with one or more
valuation specialists, to analyze the impact, if any, on our assessment of the reporting units
fair value. We have not to date deemed there to be any significant adverse changes in the legal,
regulatory or business environment in which we conduct our operations.
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Results of Operations
Three Months Ended March 31, 2011 Compared to the Three Months Ended March 31, 2010
Overview:
The following table sets forth our summarized, consolidated results of operations for the
three months ended March 31, 2011 and 2010:
Three Months Ended | Increase/ | |||||||||||||||
March 31, | March 31, | (Decrease) | ||||||||||||||
(in $000s) | 2011 | 2010 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Total revenues |
$ | 108,651 | $ | 323,333 | $ | (214,682 | ) | (66 | )% | |||||||
Gross profit |
58,537 | 243,757 | (185,220 | ) | (76 | )% | ||||||||||
Income from operations |
20,694 | 210,979 | (190,285 | ) | (90 | )% | ||||||||||
Income before income taxes |
21,002 | 210,997 | (189,995 | ) | (90 | )% | ||||||||||
Provision for income taxes |
7,144 | 79,484 | (72,340 | ) | (91 | )% | ||||||||||
13,858 | 131,513 | (117,655 | ) | (89 | )% | |||||||||||
Non-controlling interest |
5 | (28 | ) | 33 | 118 | % | ||||||||||
Net income |
$ | 13,863 | $ | 131,485 | $ | (117,622 | ) | (89 | )% | |||||||
Net Income
Net income for the three months ended March 31, 2011 was $13.9 million, a decrease of $117.6
million as compared to $131.5 million for the three months ended March 31, 2010 primarily
attributable to decreased Global Product sales, net, principally driven by a decrease in revenue
earned from the sale of our tamsulosin product, resulting in a period-over-period decrease in total
revenues and gross profit, partially offset by a corresponding decrease in the provision for income
taxes. In the three months ended March 31, 2010, sales of our tamsulosin product benefited from an
eight week contractual market exclusivity period that began on March 2, 2010 for which there was
no similar contractual market exclusivity period in the three months ended March 31, 2011. As
discussed throughout this section, we continued to earn significant revenues and gross profit from
sales of our authorized generic Adderall XR® and fenofibrate products during the three months ended
March 31, 2011. With respect to our authorized generic Adderall XR® products, we are dependent on
another unrelated third-party pharmaceutical company to supply us with such products we market and
sell through our Global Division. We experienced disruptions related to the supply of our
authorized generic Adderall XR® under the license and distribution agreement during the three
months ended March 31, 2011. Any continued delay or interruption in whole or part in the supply of
our authorized generic Adderall XR® products from the unrelated third-party pharmaceutical company
could curtail or delay our product shipments and adversely affect our revenues, as well as
jeopardize our relationships with our customers. Any significant diminution in the sales revenue
and /or gross profit of our authorized generic Adderall XR® and fenofibrate and any other of our
products due to competition and /or product supply or any other reasons in future periods may
materially and adversely affect our results of operations in such future periods.
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Global Division
The following table sets forth results of operations for the Global Division for the three
months ended March 31, 2011 and 2010:
Three Months Ended | Increase/ | |||||||||||||||
March 31, | March 31, | (Decrease) | ||||||||||||||
(in $000s) | 2011 | 2010 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenues: |
||||||||||||||||
Global Product sales, net |
$ | 91,946 | $ | 309,105 | $ | (217,159 | ) | (70 | )% | |||||||
Private Label Product sales |
392 | 672 | (280 | ) | (42 | )% | ||||||||||
Rx Partner |
2,682 | 4,903 | (2,221 | ) | (45 | )% | ||||||||||
OTC Partner |
1,943 | 1,765 | 178 | 10 | % | |||||||||||
Research Partner |
6,385 | 3,385 | 3,000 | 89 | % | |||||||||||
Total revenues |
103,348 | 319,830 | (216,482 | ) | (68 | )% | ||||||||||
Cost of revenues |
47,174 | 76,432 | (29,258 | ) | (38 | )% | ||||||||||
Gross profit |
56,174 | 243,398 | (187,224 | ) | (77 | )% | ||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
9,776 | 9,435 | 341 | 4 | % | |||||||||||
Patent litigation |
1,774 | 1,984 | (210 | ) | (11 | )% | ||||||||||
Selling, general and administrative |
2,931 | 3,334 | (403 | ) | (12 | )% | ||||||||||
Total operating expenses |
14,481 | 14,753 | (272 | ) | (2 | )% | ||||||||||
Income from operations |
$ | 41,693 | $ | 228,645 | $ | (186,952 | ) | (82 | )% | |||||||
Revenues
Total revenues for the Global Division for the three months ended March 31, 2011, were $103.3
million, a decrease of 68% over the same period in 2010.
Global Product sales, net, were $91.9 million for the three months ended March 31, 2011, a
decrease of 70% over the same period in 2010 primarily as a result of lower sales of our
tamsulosin and authorized generic Adderall XR® products, partially offset by higher sales of our
fenofibrate products. As noted, we commenced sales of our tamsulosin product, a generic version of
Flomax® used to improve symptoms associated with an enlarged prostrate, on March 2, 2010 and had a
contractual market exclusivity period for this product for the succeeding eight weeks and, as a
result, we were able to achieve high market-share penetration in the three months ended March 31,
2010. Following the expiration of our market exclusivity, competing generic versions to our own
generic version of the tamsulosin product began entering the market in April 2010, resulting in
both price erosion and reduction of our market share. The decrease in sales of our authorized
generic Adderall XR® products, indicated for the treatment of attention deficit hyperactivity
disorder, was the result of the product supply disruptions noted above. The increase in sales of
our fenofibrate products, a cholesterol-lowering drug, resulted from a continued increase in
general demand for generic versions of cholesterol-lowering drugs.
Private Label Product sales were $0.4 million for the three months ended March 31, 2011, a
decrease of 42% over the prior year period primarily due to lower demand for our generic loratadine
/pseudoephedrine products.
Rx Partner revenues were $2.7 million for the three months ended March 31, 2011, a decrease of
45% over the prior year period attributable to lower sales of our products marketed under the Teva
Agreement, including generic Wellbutrin® XL 300mg, as a result of lower overall product orders from
Teva.
OTC Partner revenues were $1.9 million for the three months ended March 31, 2011, representing
a slight increase of $0.2 million over the prior year period, generally resulting from higher
levels of profit share revenue recognition.
Research Partner revenues were $6.4 million for the three months ended March 31, 2011, an
increase of $3.0 million over the prior year period, resulting principally from the recognition of
revenue related to a $3.0 milestone payment which was earned in the three months ended March 31,
2011.
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Cost of Revenues
Cost of revenues was $47.2 million for the three months ended March 31, 2011 a decrease of
$29.3 million, or 38%, from the prior year period primarily related to lower sales of our
tamsulosin and authorized generic Adderall XR® products.
Gross Profit
Gross profit for the three months ended March 31, 2011 was $56.2 million, or approximately 54%
of total revenues, as compared to $243.4 million, or approximately 76% of total revenue, in the
prior year period. The lower gross profit in our Global Division in the three months ended March
31, 2011 was primarily due to lower sales of our tamsulosin and authorized generic Adderall XR®
products, as discussed above.
Research and Development Expenses
Total research and development expenses for the three months ended March 31, 2011 were $9.8
million, an increase of 4%, as compared to the same period of the prior year. Generic research and
development expenses increased primarily as a result of $0.7 million higher spending on
bio-equivalency study costs, partially offset by $0.2 million of lower expenses related active
pharmaceutical ingredient used for research purposes.
Patent Litigation Expenses
Patent litigation expenses for the three months ended March 31, 2011 and 2010 were $1.8
million and $2.0 million, respectively, a slight decrease of $0.2 million due to lower overall
activity in the current year period.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended March 31, 2011 were
$2.9 million, a 12% decrease over the prior year period, primarily attributable to overall lower
sales levels period over period, and included $0.5 million in lower sales personnel incentive
compensation, and a decrease in product freight charges of $0.3 million; partially offset by
post-approval product clinical study costs of $0.3 million, for which there was no amount present
in the prior year period.
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Impax Division
The following table sets forth results of operations for the Impax Division for the three
months ended March 31, 2011 and 2010:
Three Months Ended, | Increase/ | |||||||||||||||
March 31, | March 31, | (Decrease) | ||||||||||||||
(in $000s) | 2011 | 2010 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenues: |
||||||||||||||||
Rx Partner |
$ | 1,438 | $ | | 1,438 | nm | ||||||||||
Promotional Partner |
3,535 | 3,503 | 32 | 1 | % | |||||||||||
Research Partner |
330 | | 330 | nm | ||||||||||||
Total revenues |
5,303 | 3,503 | 1,800 | 51 | % | |||||||||||
Cost of revenues |
2,940 | 3,144 | (204 | ) | (7 | )% | ||||||||||
Gross profit |
2,363 | 359 | 2,004 | 558 | % | |||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
9,714 | 8,874 | 840 | 9 | % | |||||||||||
Selling, general and administrative |
1,107 | 809 | 298 | 37 | % | |||||||||||
Total operating expenses |
10,821 | 9,683 | 1,138 | 12 | % | |||||||||||
Loss from operations |
$ | (8,458 | ) | $ | (9,324 | ) | 866 | 9 | % | |||||||
| nm not meaningful |
Revenues
Total revenues were $5.3 million for the three months ended March 31, 2011, an increase of 51%
compared to the same period in the prior year, principally driven by $1.4 million of Rx Partner
revenue recognition related to the up-front payment received under our License, Development and
Commercialization Agreement with Glaxo Group Limited entered into in December 2010, for which there
were no similar revenues in the prior year period. In addition, we recognized $0.3 million of
Research Partner revenue resulting from our Development and Co-Promotion Agreement with Endo
Pharmaceuticals, Inc, entered into in June 2010, for which there were no similar revenues in the
prior year period.
Cost of Revenues
Cost of revenues was $2.9 million for the three months ended March 31, 2011, with nominal
change from the same period in 2010. Cost of revenues for the Impax Division is primarily composed
of expenditures related to our sales force which provides physician detailing services under a
promotional services agreement with an unrelated pharmaceutical company.
Gross Profit
Gross profit for the three months ended March 31, 2011 was $2.4 million, an increase of $2.0
million over the prior year period primarily resulting from increases in Rx Partner and Research
Partner revenues as described above.
Research and Development Expenses
Total research and development expenses for the three months ended March 31, 2011 were $9.7
million, an increase of 9%, as compared to $8.9 million in the prior year period, with the $0.8
million increase principally driven by research and development expenses related to our branded
product initiatives, including increases of $0.4 million for consulting expenses and $0.3 million
for active pharmaceutical ingredient used in research related activities.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $1.1 million in the current period as
compared to $0.8 million in the prior period, with the increase primarily related to new product
planning activities.
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Corporate and other
The following table sets forth corporate general and administrative expenses, as well as other
items of income and expense presented below Income from operations for the three months ended March
31, 2011 and 2010:
Three Months Ended | Increase/ | |||||||||||||||
March 31, | March 31, | (Decrease) | ||||||||||||||
(in $000s) | 2011 | 2010 | $ | % | ||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
General and administrative expenses |
$ | 12,541 | $ | 8,342 | 4,199 | 50 | % | |||||||||
Loss from operations |
(12,541 | ) | (8,342 | ) | (4,199 | ) | (50 | )% | ||||||||
Other income (expense), net |
3 | (18 | ) | 21 | 117 | % | ||||||||||
Interest income |
321 | 82 | 239 | 292 | % | |||||||||||
Interest expense |
(16 | ) | (46 | ) | 30 | 65 | % | |||||||||
Loss before income taxes |
(12,233 | ) | (8,324 | ) | (3,909 | ) | (47 | )% | ||||||||
Provision for income taxes |
$ | 7,144 | $ | 79,484 | (72,340 | ) | (91 | )% |
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2011 were $12.5
million, a $4.2 million increase over the prior period, principally driven by an increase in
executive compensation-related expenses of $1.0 million, higher corporate legal expenses of $1.2
million and an increase in information technology systems related expenses of $1.2 million.
Other income (expense), net
Other income (expense), net for the three months ended March 31, 2011 and 2010 contained no
individually-significant items.
Interest Income
Interest income in the three months ended March 31, 2011 was $0.3 million, with a period over
period increase of $0.2 million resulting from higher average balances of cash and cash equivalents
and short-term investments.
Interest Expense
Interest expense in the three months ended March 31, 2011 and 2010 was primarily the result of
the amortization of deferred financing costs.
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Income Taxes
We calculate our interim income tax provision in accordance with FASB ASC Topics 270 and 740.
At the end of each interim period, we make an estimate of the annual expected effective tax rate
and apply the estimated effective rate to our year-to-date taxable income or loss. In addition,
the effect of changes in enacted tax laws, rates, or tax status is recognized in the interim period
in which such change occurs. The computation of the annual estimated effective tax rate 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 and temporary differences, and the
likelihood of recovering deferred tax assets. 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 rate
includes modifications, which were projected for the year, for share-based compensation, the
domestic manufacturing deduction, and state research and development credits, among others. During
the three months ended March 31, 2011, we recorded an aggregate tax provision of $7.1 million for
United States domestic income taxes and for foreign income taxes. In the three months ended March
31, 2010, the Company recorded an aggregate tax provision of $79.5 million for United States
domestic income taxes and for foreign income taxes. The decrease in the tax provision resulted
from lower income before taxes in the three months ended March 31, 2011 as compared to the same
period in the prior year, resulting principally from the reduced products sales revenue and gross
profit as discussed above. The tax provision for the three months ended March 31, 2011 includes
the effect of the federal research and development tax credit, enacted on December 17, 2010,
retroactive to January 1, 2010. Conversely, the tax provision for the three months ended March 31,
2010 does not include the effect of a federal research and development tax credit which had
previously expired on December 31, 2009. The effective tax rate of 34% for the three months ended
March 31, 2011 was lower than the effective tax rate of 38% for the three months ended March 31,
2010, primarily due to the absence of the federal research and development tax credit in the prior
year period. In addition, due to the lower level of income before income taxes in the three months
ended March 31, 2011 as compared to the prior year period, the aggregate net federal and state
research and development tax credits have a more pronounced effect on our effective tax rate in the
current year period.
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Liquidity and Capital Resources
We have historically funded our operations with the proceeds from the sale of debt and equity
securities, and more recently, with cash from operations. Currently, our principal source of
liquidity is cash from operations, consisting of the proceeds from the sales of our products and
provision of services.
We expect to incur significant operating expenses, including expanded research and development
activities and patent litigation expenses, for the foreseeable future. We estimate research and
development expenses will be approximately $87.0 million and patent litigation expenses will be
approximately $13.0 million for the 12 months ending December 31, 2011. We also anticipate
incurring capital expenditures of approximately $69.0 million during the 12 months ending December
31, 2011, principally for continued improvements and expansion of our research and development and
manufacturing facilities in the State of California, and of our packaging and distribution
facilities in the Commonwealth of Pennsylvania; as well as the continuing construction of our
manufacturing facility in Jhunan, Taiwan, R.O.C. In addition, we are generally required to make
cash expenditures to manufacture and /or acquire finished product inventory in advance of selling
the finished product to our customers and collecting payment for such product sales, which may
result in a significant use of cash.
We believe our existing cash and cash equivalents and short-term investment balances, together
with cash expected to be generated from operations, and our bank revolving line of credit, will be
sufficient to meet our financing requirements through the next 12 months. We may, however, seek
additional financing through alliance, collaboration, and /or licensing agreements, as well as from
the equity and /or debt capital markets to fund the planned capital expenditures, our research and
development plans, potential acquisitions, and potential revenue shortfalls due to delays in new
product introductions.
Cash and Cash Equivalents
At March 31, 2011, we had $140.7 million in cash and cash equivalents, an increase of $48.9
million as compared to December 31, 2010. As more fully discussed below, the increase in cash and
cash equivalents during the three months ended March 31, 2011 was primarily driven by $38.9 million
of cash provided by investing activities, which included net maturities of short-term investments
of $47.6 million partially offset by $8.7 million of purchases of property, plant, and equipment.
The increase in cash was also impacted by $6.7 million received from the exercise of stock options
and employee stock purchase plan contributions.
Cash Flows
Three Months Ended March 31, 2011 Compared to the Three Months Ended March 31, 2010.
Net cash provided by operating activities for the three months ended March 31, 2011 was $1.0
million, a decrease of $36.6 million as compared to the prior year period $37.6 million net cash
provided by operating activities. The period-over-period decrease in net cash provided by
operating activities principally resulted from lower net income, accounts payable and accrued
expenses, partially offset by lower accounts receivable period-over-period. The balance of
accounts receivable was $94.3 million at March 31, 2011, resulting in a $12.3 million use of cash
for the three months ended March 31, 2011, compared to the same period in the prior year when
accounts receivable resulted in a $138.9 million use of cash flows. In addition, lower levels of
accounts payable and accrued expenses resulted in a period-over-period decrease of $62.2 million in
cash flows. The decreased level of accounts receivable, and corresponding cash used in operations
as of and for the three months ended March 31, 2011, was primarily the result of lower sales of our
tamsulosin and authorized generic Adderall XR® products in the current year period, as described
above.
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Net cash provided by investing activities for the three months ended March 31, 2011, amounted
to $38.9 million, an increase of $30.0 million as compared to the prior year period $8.9 million of
cash flows provided by investing activities, with the change due to a period-over-period $35.6
million net increase in maturities of short-term investments, partially offset by $5.6 million in
higher expenditures on property, plant and equipment. Net maturities of short-term investments
during the three months ended March 31, 2011 resulted in a $47.6 million source of cash, as
compared to a $12.0 million source of cash from net maturities of short-term investments during the
same period in the prior year. Purchases of property, plant and equipment for the three months
ended March 31, 2011 amounted to $8.7 million as compared to $3.1 million for the prior year
period. We expect continued investment in facilities, equipment, and information technology
projects supporting our quality initiatives to ensure we have appropriate levels of technology
infrastructure to manage and grow our global business.
Net cash provided by financing activities for the three months ended March 31, 2011 was $9.0
million, representing an increase of $3.6 million as compared to the prior year period $5.4 million
of net cash provided by financing activities. The period-over-period increase in net cash provided
by financing activities was due to an increase in cash proceeds received from the exercise of stock
options and contributions to the employee stock purchase plan.
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Outstanding Debt Obligations
Senior Lenders; Wells Fargo Bank, N.A.
On February 11, 2011, we entered into a Credit Agreement (the Credit Agreement) with Wells
Fargo Bank, National Association, as a lender and as administrative agent (the Administrative
Agent). The Credit Agreement provides us with a revolving line of credit in the aggregate
principal amount of up to $50.0 million (the Revolving Credit Facility). Under the Revolving
Credit Facility, up to $10.0 million 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.
Borrowings under the Credit Agreement are secured by substantially all of our personal
property assets pursuant to a Security Agreement (the Security Agreement) entered into by us and
the Administrative Agent. As further security, we also pledged to the Administrative Agent, 65% of
our equity interest in Impax Laboratories (Taiwan), Inc. and must similarly pledge all or a portion
of our 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 our 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%. We are 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 Companys Total Net Leverage Ratio (as defined in the Credit Agreement), which is based upon our 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. |
| We may prepay any outstanding loan under the Revolving Credit Facility without premium or penalty. |
| We are 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 us to provide periodic reports, notices of material events and information regarding collateral, (ii) restrict our, 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) requires us to maintain a Total Net Leverage Ratio (which is, generally, our total funded debt, net of unrestricted cash in excess of $100 million, over our EBITDA for the preceding four quarters) of less than 3.75 to 1.00, a Senior Secured Leverage Ratio (which is, generally, our total senior secured debt over our EBITDA for the preceding four quarters) of less than 2.50 to 1.00 and a Fixed Charge Coverage Ratio (which is, generally, our 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). At March 31, 2011, we were in compliance with the various covenants contained in the Credit Agreement and the Supply 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. |
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We have not yet borrowed any amounts under the Revolving Credit Facility.
Effective with the February 11, 2011 execution of the Credit Agreement discussed above, our
former credit agreement under the Amended and Restated Loan and Security Agreement, dated as of
December 15, 2005, as amended, between us and the Administrative Agent (as successor by merger to
Wachovia Bank, National Association), 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, 2011 and 2010, unused line fees incurred under each of the aforementioned
respective credit agreements were $50,000 and $44,000, respectively.
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Recent Accounting Pronouncements
In March 2010, the FASB approved the Milestone Method of Revenue Recognition, which
addresses accounting for arrangements in which a vendor satisfies its performance obligations over
time, with all or a portion of the consideration contingent on future events, referred to as
milestones. The Milestone Method of Revenue Recognition is limited to arrangements which involve
research or development activities. A milestone is defined as an event for which, at the date the
arrangement is entered into, there is substantive uncertainty whether the event will be achieved,
and the achievement of the event is based in whole or in part on either the vendors performance or
a specific outcome resulting from the vendors performance. In addition, the achievement of the
event would result in additional payments being due to the vendor. The Milestone Method of Revenue
Recognition allows a vendor to adopt an accounting policy to recognize arrangement consideration
that is contingent on the achievement of a substantive milestone in its entirety in the period the
milestone is achieved. The Milestone Method of Revenue Recognition is effective on a prospective
basis, with an option for retrospective application, for milestones achieved in fiscal years and
interim periods within those fiscal years beginning on or after June 15, 2010. We recognized $3.0
million of revenue for a research and development milestone we achieved during the three months
ended March 31, 2011 pursuant to the terms of our Joint Development Agreement with Medicis
Pharmaceutical Corporation.
In December 2010, the FASB issued Accounting Standards Update No. 2010-27, Fees Paid to the
Federal Government by Pharmaceutical Manufacturers (Subtopic 720-50), which provides guidance on
the annual fee paid by pharmaceutical manufacturers to the U.S. Treasury in accordance with the
Patient Protection and Affordable Care Act as amended by the Health Care and Education
Reconciliation Act (the Acts). The Acts impose an annual fee on the pharmaceutical manufacturing
industry for each calendar year beginning on or after January 1, 2011. An entitys portion of the
annual fee is payable no later than September 30 of the applicable calendar year and is not tax
deductible. The annual fee ranges from $2.5 billion to $4.1 billion in total, a portion of which
will be allocated to individual entities on the basis of the amount of their branded prescription
drug sales for the preceding year as a percentage of the industrys branded prescription drug sales
for the same period. An entitys portion of the annual fee becomes payable to the U.S. Treasury
once a pharmaceutical manufacturing entity has a gross receipt from branded prescription drug sales
to any specified government program or in accordance with coverage under any government program for
each calendar year beginning on or after January 1, 2011. The liability related to the annual fee
imposed by the Acts shall be estimated and recorded in full upon the first qualifying sale with a
corresponding deferred cost that is amortized to expense using a straight-line method of allocation
unless another method better allocates the fee over the calendar year that it is payable. The
guidance in Subtopic 720-50 becomes effective for calendar years beginning after December 31, 2010.
Upon becoming effective this update did not have a material impact on our consolidated financial
statements.
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There were no material changes to the quantitative and qualitative disclosures about market
risk set forth in our Annual Report on Form 10-K for the year ended December 31, 2010.
ITEM 4. | CONTROLS AND PROCEDURES |
Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures (as defined in Rule 13a-15(e) of the
Exchange Act) that are designed to ensure that information required to be disclosed by the Company
in reports that it files or submits under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms, and that such information
is accumulated and communicated to the Companys management, including its principal executive
officer and principal financial officer, as appropriate, to allow timely decisions regarding
required disclosure.
The Companys management, with the participation of the Companys Chief Executive Officer and
Chief Financial Officer, evaluated the effectiveness of the Companys disclosure controls and
procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon
that evaluation, the Companys Chief Executive Officer and Chief Financial Officer concluded that
the Companys disclosure controls and procedures, as defined in Rule 13a-15(e) of the Exchange Act,
were effective as of March 31, 2011.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2011, the Company implemented an enterprise resource
planning system using SAP software throughout its U.S. locations to improve the Companys business
processes. The implementation of the SAP software system has involved changes to certain internal
controls over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act), which the
Company believes were material. During the quarter ended March 31, 2011, there were no other
changes in the Companys internal control over financial reporting which materially affected, or
are reasonably likely to materially affect, the Companys internal control over financial
reporting.
Limitations on the Effectiveness of Controls
Systems of internal control and their associated policies and procedures, no matter how well
conceived and operated, are designed to provide a reasonable, but not an absolute, level of
assurance the objectives of the system of internal control are achieved. Further, the design of a
system of internal control must be balanced against resource constraints, and therefore the
benefits of internal controls must be considered relative to their costs. Given the inherent
limitations in all systems of internal controls, no evaluation of internal controls can provide
absolute assurance all internal control issues and instances of fraud, if any, within a Company
have been detected. Accordingly, given the inherent limitations in a cost-effective system of
internal control, financial statement misstatements due to error or fraud may occur and may not be
detected. The Company conducts periodic evaluations of its system of internal controls to enhance,
where necessary, its internal control policies and procedures.
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PART II. OTHER INFORMATION
ITEM 1. | LEGAL PROCEEDINGS |
Patent Infringement Litigation
Aventis Pharmaceuticals Inc., et al. v. Impax Laboratories, Inc.
(Fexofenadine/Pseudoephedrine)
We are a defendant in an action brought in March 2002 by Aventis Pharmaceuticals Inc. and
others in the U.S. District Court for the District of New Jersey alleging our proposed Fexofenadine
and Pseudoephedrine Hydrochloride tablets, generic to Allegra-D®, infringe seven Aventis patents
and seeking an injunction preventing us from marketing the products until expiration of the
patents. The case has since been consolidated with similar actions brought by Aventis against five
other manufacturers (including generics to both Allegra® and Allegra-D®). In March 2004, Aventis
and AMR Technology, Inc. filed a complaint and first amended complaint against us and one of the
other defendants alleging infringement of two additional patents, owned by AMR and licensed to
Aventis, relating to a synthetic process for making the active pharmaceutical ingredient,
Fexofenadine Hydrochloride and intermediates in the synthetic process. We believe we have defenses
to the claims based on non-infringement and invalidity.
In June 2004, the court granted our motion for summary judgment of non-infringement with
respect to two of the patents and, in May 2005, granted summary judgment of invalidity with respect
to a third patent. We will have the opportunity to file additional summary judgment motions in the
future and to assert both non-infringement and invalidity of the remaining patents (if necessary)
at trial. No trial date has yet been set. In September 2005, Teva Pharmaceuticals, USA launched
its Fexofenadine tablet products (generic to Allegra®), and Aventis and AMR moved for a preliminary
injunction to bar Tevas sales based on four of the patents in suit, which patents are common to
the Allegra® and Allegra-D® litigations. The district court denied Aventiss motion in January
2006, finding Aventis did not establish a likelihood of success on the merits, which decision was
affirmed on appeal. Discovery is complete and summary judgment motions have been filed. On March
29, 2011, the district court entered an Order of Dismissal based upon the parties agreement on
settlement terms, with the parties having the right to reopen the case in the event a settlement is
not consummated within 60 days.
Pfizer Inc., et aI. v. Impax Laboratories, Inc. (Tolterodine)
In March 2008, Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB
(collectively, Pfizer) filed a complaint against us in the U.S. District Court for the Southern
District of New York, alleging our filing of an ANDA relating to Tolterodine Tartrate Extended
Release Capsules, 4 mg, generic to Detrol® LA, infringes three Pfizer patents. We 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 our ANDA amendment adding a 2mg strength. For one of the
patents-in-suit, U.S. Patent No. 5,382,600, expiring on September 25, 2012 with pediatric
exclusivity, we 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.). After the Pfizer court conducted a bench
trial, it found the 600 patent not invalid on January 20, 2010, and that decision is on appeal to
the U.S. Court of Appeals for the Federal Circuit. Discovery is proceeding in our case, and no
trial date has been set.
In December 2010, we filed a separate declaratory judgment action against Pfizer in the U.S.
District Court for the District of New Jersey, requesting that the district court declare that one
of the patents-in-suit, U.S. Patent No. 6,911,217, listed in the FDAs publication Approved Drug
Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book), for
Detrol LA® is invalid. Pfizer filed a motion to dismiss the declaratory action for lack of subject
matter jurisdiction or, alternatively, because our sole claim should have been brought as a
compulsory counterclaim in the March 2008 action currently pending between the parties. The parties
are awaiting a decision on Pfizers motion.
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Eli Lilly and Company v. Impax Laboratories, Inc. (Duloxetine)
In November 2008, Eli Lilly and Company filed suit against us in the U.S. District Court for
the Southern District of Indiana, alleging patent infringement for the filing of our ANDA relating
to Duloxetine Hydrochloride Delayed Release Capsules, 20 mg, 30 mg, and 60 mg, generic to
Cymbalta®. In February 2009, the parties agreed to be bound by the final judgment concerning
infringement, validity and enforceability of the patent at issue in cases brought by Eli Lilly
against other generic drug manufacturers that have filed ANDAs relating to this product and
proceedings in this case were stayed. In March 2011, a stipulated final judgment of patent
infringement and validity was entered against Wockhardt Limited. A telephonic status conference is
scheduled for April 22, 2011 to discuss whether trial on the patent in suit should proceed in June
2011.
Abbott Laboratories, et al. v. Impax Laboratories, Inc. (Niacin-Simvastatin)
In November 2010, Abbott Laboratories and Abbott Respiratory LLC filed suit against us in the
U.S. District Court for the District of Delaware, alleging patent infringement for the filing of
our ANDA relating to Niacin-Simvastatin Tablets, 1000/20 mg, generic to Simcor®. We have filed an
answer and counterclaim.
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 us in the U.S. District Court for the District of Delaware, alleging patent
infringement for the filing of our ANDA relating to Methylphenidate Hydrochloride Tablets, 54 mg,
generic to Concerta®. We have filed our answer. In March 2011, the case was stayed until the
earlier of (a) six months from the stay date, or (b) the date the district court issues an opinion
on the motion for summary judgment of patent invalidity filed in Alza Corp. v. Kremers Urban, LLC,
Case No. 10-00023 (D. Del.).
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 us in the U.S.
District Court for the Northern District of California alleging patent infringement for the filing
of our 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. We have filed an
answer and counterclaims.
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 us in the U.S. District Court for the Northern District of California alleging patent
infringement for the filing of our ANDA relating to Dexlansoprazole Delayed Release Capsules, 30
and 60 mg, generic to Dexilant®.
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 us in the U.S. District Court for the Southern District
of New York alleging patent infringement based on the filing of our ANDA relating to Oxycodone
Hydrochloride, Controlled Release Tablets, 10, 15, 20, 30, 40, 60 and 80 mg, generic to Oxycontin®.
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Other Litigation Related to Our Business
Budeprion XL Litigation
In June 2009, we were 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 us 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 have been removed to federal court, and a petition for multidistrict litigation
to consolidate the cases in federal court has been 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. We filed a motion to dismiss and a motion to certify that
order for interlocutory appeal, both of which were denied. Plaintiffs have filed a motion for
class certification and we have filed an opposition to that motion. The class certification
hearing is set for May 17, 2011, and expert discovery closes on May 27, 2011. No trial date has
been scheduled.
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ITEM 1A. RISK FACTORS
During the quarter ended March 31, 2011, there were no material changes to the risk
factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the
risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the
year ended December 31, 2010, which could materially affect our business, financial condition or
future results. The risks described in our Annual Report on Form 10-K are not the only risks we
face. Additional risks and uncertainties not currently known to us or that we currently deem to be
immaterial also may materially adversely affect our business, financial condition and/or operating
results.
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ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
The following table provides information regarding the purchases of our equity securities by
us during the three months ended March 31, 2011.
Total | ||||||||||||||||
Number of | ||||||||||||||||
Shares (or | ||||||||||||||||
Units) | ||||||||||||||||
Purchased | Maximum Number (or | |||||||||||||||
as Part of | Approximate Dollar | |||||||||||||||
Average | Publicly | Value) of Shares (or | ||||||||||||||
Total Number of | Price Paid | Announced | Units) that May Yet | |||||||||||||
Shares (or Units) | Per Share | Plans or | Be Purchased Under | |||||||||||||
Period | Purchased(1) | (or Unit) | Programs | the Plans or Programs | ||||||||||||
January 1, 2011 to January 31, 2011 |
309 shares of common stock | $ | 20.30 | | | |||||||||||
February 1, 2011 to February 28, 2011 |
19,932 shares of common stock | $ | 23.95 | | | |||||||||||
March 1, 2011 to March 31, 2011 |
5,250 shares of common stock | $ | 22.00 | | |
(1) | Represents shares of our common stock we accepted during the indicated periods as a tax withholding from certain of our employees in connection with the vesting of shares of restricted stock pursuant to the terms of our 2002 Plan. |
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ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
Not Applicable.
ITEM 4. | (REMOVED AND RESERVED) |
ITEM 5. | OTHER INFORMATION |
Not Applicable.
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ITEM 6. | EXHIBITS |
Exhibit No. | Description of Document | |||
10.1 | Seventh Amendment to Amended and Restated Loan and Security
Agreement, effective as of January 31, 2011, by and among the
Company and Wells Fargo Bank, National Association, successor
by merger to Wachovia Bank, National Association. (1) |
|||
10.2 | Credit Agreement, dated as of February 11, 2011, by and among
the Company, the Guarantors named therein, the Lenders named
therein and Wells Fargo Bank, National Association, as
Administrative Agent.* |
|||
10.3 | Security Agreement, dated as of February 11, 2011, by and
among the Company, the Guarantors named therein and Wells
Fargo Bank, National Association, as Administrative Agent. |
|||
10.4 | Joint Development Agreement, dated as of November 26, 2008,
between the Company and Medicis Pharmaceutical Corporation.** |
|||
11.1 | Statement re computation of per share earnings (incorporated
by reference to Note 14 to the Notes to the unaudited interim
Consolidated Financial Statements in this Quarterly Report on
Form 10-Q). |
|||
31.1 | Certification of the Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|||
31.2 | Certification of the Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|||
32.1 | Certification of the Chief Executive Officer Pursuant to 18
U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
|||
32.2 | Certification of the Chief Financial Officer Pursuant to 18
U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
|||
101 | The following materials from the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2011, formatted in
XBRL (eXtensible Business Reporting Language); (i)
Consolidated Balance Sheets as of March 31, 2011 and December
31, 2010, (ii) Consolidated Statements of Operations for each
of the three months ended March 31, 2011 and 2010, (iii)
Consolidated Statements of Cash Flows for each of the three
months ended March 31, 2011 and 2010, and (iv) Notes to
Consolidated Financial Statements.*** |
* | Confidential treatment requested for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
** | The Company is re-filing the Joint Development Agreement, dated as of November 26, 2008 (the Joint Development Agreement), with Medicis Pharmaceutical Corporation to disclose a milestone payment that was previously omitted in accordance with an order granting confidential treatment pursuant to Rule 24b-2 under the Exchange Act. Certain portions of the Joint Development Agreement remain confidential pursuant to an order granting confidential treatment under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
*** | Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections. | |
(1) | Incorporated by reference to the Companys Annual Report on Form 10-K for the year ended December 31, 2010. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: May 5, 2011 | Impax Laboratories, Inc. |
|||
By: | /s/ Larry Hsu, Ph.D. | |||
Name: | Larry Hsu, Ph.D. | |||
Title: | President and Chief Executive Officer (Principal Executive Officer) |
|||
By: | /s/ Arthur A. Koch, Jr. | |||
Name: | Arthur A. Koch Jr. | |||
Title: | Executive Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
Exhibit No. | Description of Document | |||
10.1 | Seventh Amendment to Amended and Restated Loan and Security
Agreement, effective as of January 31, 2011, by and among the
Company and Wells Fargo Bank, National Association, successor
by merger to Wachovia Bank, National Association. (1) |
|||
10.2 | Credit Agreement, dated as of February 11, 2011, by and among
the Company, the Guarantors named therein, the Lenders named
therein and Wells Fargo Bank, National Association, as
Administrative Agent.* |
|||
10.3 | Security Agreement, dated as of February 11, 2011, by and
among the Company, the Guarantors named therein and Wells
Fargo Bank, National Association, as Administrative Agent. |
|||
10.4 | Joint Development Agreement, dated as of November 26, 2008,
between the Company and Medicis Pharmaceutical Corporation.** |
|||
11.1 | Statement re computation of per share earnings (incorporated
by reference to Note 14 to the Notes to the unaudited interim
Consolidated Financial Statements in this Quarterly Report on
Form 10-Q). |
|||
31.1 | Certification of the Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|||
31.2 | Certification of the Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|||
32.1 | Certification of the Chief Executive Officer Pursuant to 18
U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
|||
32.2 | Certification of the Chief Financial Officer Pursuant to 18
U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
|||
101 | The following materials from the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2011, formatted in
XBRL (eXtensible Business Reporting Language); (i)
Consolidated Balance Sheets as of March 31, 2011 and December
31, 2010, (ii) Consolidated Statements of Operations for each
of the three months ended March 31, 2011 and 2010, (iii)
Consolidated Statements of Cash Flows for each of the three
months ended March 31, 2011 and 2010, and (iv) Notes to
Consolidated Financial Statements.*** |
* | Confidential treatment requested for certain portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
** | The Company is re-filing the Joint Development Agreement, dated as of November 26, 2008 (the Joint Development Agreement), with Medicis Pharmaceutical Corporation to disclose a milestone payment that was previously omitted in accordance with an order granting confidential treatment pursuant to Rule 24b-2 under the Exchange Act. Certain portions of the Joint Development Agreement remain confidential pursuant to an order granting confidential treatment under the Exchange Act, which portions are omitted and filed separately with the SEC. | |
*** | Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections. | |
(1) | Incorporated by reference to the Companys Annual Report on Form 10-K for the year ended December 31, 2010. |
75