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8-K - FORM 8-K - OSI PHARMACEUTICALS INC | y84029e8vk.htm |
EX-99.3 - EX-99.3 - OSI PHARMACEUTICALS INC | y84029exv99w3.htm |
EX-99.2 - EX-99.2 - OSI PHARMACEUTICALS INC | y84029exv99w2.htm |
Exhibit 99.1

NEWS RELEASE
Contacts: |
Media: | |
OSI Pharmaceuticals, Inc. |
Joele Frank, Wilkinson Brimmer Katcher | |
Kathy Galante(investors/media) |
Joele Frank/Andy Brimmer/Eric Brielmann | |
Senior Director |
212-355-4449 | |
631-962-2043 |
||
Kim Wittig (media) |
Investors: | |
Director |
Burns McClellan | |
631-962-2135 |
Lisa Burns | |
212-213-0006 |
OSI Pharmaceuticals, Inc. Announces First Quarter 2010 Financial Results
- Total Revenues Increased 14% Year over Year to $107 Million -
MELVILLE, NEW YORK April 22, 2010 OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today
its financial results for the first quarter ended March 31, 2010. The Company reported total
revenues from continuing operations of $107 million for the first quarter of 2010, a 14% increase
over revenues of $94 million for the first quarter of 2009. Total worldwide net sales of Tarceva®
(erlotinib) for the first quarter of 2010, as reported to the Company by its collaborator Roche,
were approximately $308 million, representing a 10% increase in sales over the first quarter of
2009.
The Company reported net income from continuing operations of $4.7 million (or $0.08 per share) for
the three months ended March 31, 2010, compared to $16.5 million (or $0.28 per share) for the three
months ended March 31, 2009. The decline was due primarily to $11 million in costs recorded in
connection with the unsolicited tender offer commenced by Astellas Pharma, Inc. in March 2010, and
an $8 million non-operating impairment on the Companys investment holding in AVEO Pharmaceuticals,
Inc. following that companys IPO.
The Company reported that non-GAAP net income from continuing operations increased to $39.6 million
(or $0.63 per share) for the first quarter of 2010, compared to $36.0 million (or $0.58 per share)
in the first quarter of 2009. The Company adjusted for non-cash tax expense (to reflect OSIs
actual cash tax rate of approximately 3%), tender offer related costs, restructuring and other
charges related to our consolidation of U.S. operations in Ardsley, New York, expense related to
equity-based compensation, non-cash interest expense on our convertible notes, and certain other
items detailed in the attached reconciliation of GAAP to non-GAAP financial measures.
Total revenues for the first quarter were comprised of the following key items:
| Tarceva-related revenues of $92 million in the first quarter of 2010 compared with $84 million for the same period in 2009, based on the following: |
- | Net revenues from the unconsolidated joint business for Tarceva of $52 million for the first quarter of 2010, compared to $49 million in the first quarter of 2009, arising from the Companys co-promotion arrangement with Genentech, a wholly owned member of the Roche Group. The net revenues are based on total U.S. Tarceva sales of $114 million for the first quarter of 2010, compared to $111 million in the first quarter of 2009. First quarter sales in both 2009 and 2010 were impacted by reimbursement challenges relating to the reset of the donut hole for Medicare Part D patients receiving Tarceva; |
- | Royalties on product licenses of $40 million for the first quarter of 2010 compared to $34 million in the first quarter of 2009 from Roche for sales of Tarceva. The royalty revenues are based on total rest of world sales of $194 million for the first quarter of 2010, an increase of 16% compared to the $168 million reported in the first quarter of 2009; |
| Other revenues of $14 million in the first quarter of 2010 compared with $10 million for the same period in 2009, based primarily on the following: |
- | Royalties of $13 million in 2010 compared with $9 million in 2009 related to worldwide non-exclusive licensing agreements under the Companys DP-IV patent portfolio covering the use of DP-IV inhibitors for treatment of type 2 diabetes, representing an increase of 42% over the prior year. |
Operating Expenses
Operating expenses from continuing operations for the first quarter of 2010 were $88 million
compared to $62 million for same period last year, with the increase primarily driven by tender
offer related costs, an increase in research and development expenses related to the advancement of
our clinical pipeline and an increase in Ardsley-related restructuring and consolidation project
expenses. Research and development expenses for the first quarter of 2010 were $42 million
compared to $35 million for the same period last year. Selling, general and administrative
expenses for the first quarter of 2010 were $29 million compared to $24 million for the same period
last year. OSI also recognized restructuring costs of $3 million for the Ardsley project. In 2009,
the Company previously announced plans to consolidate its U.S. operations onto a single campus in
Ardsley, New York. The consolidation project is on schedule to be completed in 2010. OSI also
recorded $11 million of expenses during the first quarter of 2010 in relation to legal, consulting
and bankers fees associated with the ongoing tender offer by Astellas Pharma Inc.
Other income (expense) net
Included in other income (expense) net for the first quarter of 2010 is a $7.9 million
impairment charge recorded to reduce the carrying value of our investment in AVEO Pharmaceuticals,
Inc. to fair market value following its public offering in March 2010.
Use of Non- GAAP Financial Measures
The accompanying tables contain both GAAP and non-GAAP financial measures for the periods
presented. The non-GAAP measures include adjusted net income from continuing operations and
adjusted diluted earnings per share from continuing operations, each of which has directly
comparable GAAP equivalents. OSI has provided these non-GAAP financial measures to adjust for the
impact of (i) restructuring and other costs related to consolidation of the Companys operations on
to a single campus in Ardsley, New York, (ii) equity-based compensation expense, (iii) imputed
interest expense related to
the application of Accounting Standards Codification Subtopic 470-20, which was effective January
1, 2009, and which provides guidance for bifurcation of the conversion feature from the debt
component of convertible debt instruments that may be settled in cash upon conversion, (iv)
amortization of acquired intangible assets, (v) non-cash tax expense to adjust OSIs effective tax
rate of approximately 40% to reflect its actual cash tax rate of approximately 3%, (vi) non-cash
impairment charges and (vii) costs related to the tender offer by Astellas Pharma, Inc. for the
Companys shares. Management uses these non-GAAP financial measures internally to evaluate the
performance of the business, including the allocation of resources as well as the planning and
forecasting of future periods and believes that these results are useful to others in analyzing the
core operating performance and trends of OSI for the periods presented. Non-GAAP financial
measures are not prepared in accordance with GAAP and therefore are not necessarily comparable to
the financial results of other companies. These non-GAAP measures should be considered as a
supplement to, not a substitute for, or superior to, the corresponding financial measures
calculated in accordance with GAAP.
Conference Call
OSI will host a conference call reviewing the Companys financial results, product portfolio and
business developments on April 22, 2010 at 5:00PM (Eastern Time). To access the live webcast via
the Internet, log on to www.osip.com. Please connect to the Companys website at least 15 minutes
prior to the conference call to ensure adequate time for any software download that may be needed
to access the webcast. Alternatively, please call 1-888-378-4350 (U.S.) or 1-719-457-2710
(international) to listen to the call. The conference ID number for the live call is 5184529.
Telephone replay is available approximately two hours after the call. To access the replay, please
call 1-888-203-1112 (U.S.) or 1-719-457-0820 (international). The conference ID number for the
replay is 5184529.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to shaping medicine and changing lives by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.
OSI Pharmaceuticals is committed to shaping medicine and changing lives by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.
This news release contains forward-looking statements. These statements are subject to known
and unknown risks and uncertainties that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such a difference include, among
others, OSIs and its collaborators abilities to effectively market and sell Tarceva and to expand
the approved indications for Tarceva, OSIs ability to protect its intellectual property rights,
safety concerns regarding Tarceva, competition to Tarceva and OSIs drug candidates from other
biotechnology and pharmaceutical companies, the completion of clinical trials, the effects of FDA
and other governmental regulation, including pricing controls, OSIs ability to successfully
develop and commercialize drug candidates, and other factors described in OSI Pharmaceuticals
filings with the Securities and Exchange Commission.
###
OSI Pharmaceuticals, Inc. and Subsidiaries
Selected Financial Information
Selected Financial Information
Consolidated Statements of Operations | Three Months Ended March 31, | |||||||
(In thousands, except per share data) | 2010 | 2009 | ||||||
Unaudited |
Unaudited |
|||||||
Revenues: |
||||||||
Tarceva-related revenues |
$ | 92,357 | $ | 83,856 | ||||
Other revenues |
14,221 | 9,821 | ||||||
Total revenues |
106,578 | 93,677 | ||||||
Operating expenses: |
||||||||
Cost of goods sold |
2,624 | 2,194 | ||||||
Research and development |
41,952 | 35,436 | ||||||
Selling, general and administrative |
29,090 | 24,201 | ||||||
Restructuring costs |
3,108 | | ||||||
Tender offer related costs |
10,646 | | ||||||
Amortization of intangibles |
218 | 228 | ||||||
Total operating expenses |
87,638 | 62,059 | ||||||
Operating income from continuing operations |
18,940 | 31,618 | ||||||
Other income (expense): |
||||||||
Investment income net |
1,380 | 2,214 | ||||||
Interest expense |
(5,292 | ) | (6,815 | ) | ||||
Other income (expense) net |
(7,118 | ) | 38 | |||||
Income from continuing operations before income taxes |
7,910 | 27,055 | ||||||
Income tax provision |
3,166 | 10,551 | ||||||
Net income from continuing operations |
4,744 | 16,504 | ||||||
Income (loss) from discontinued operations-net of tax |
107 | (104 | ) | |||||
Net income |
$ | 4,851 | $ | 16,400 | ||||
Basic and diluted income (loss) per common share: |
||||||||
Basic income (loss) |
||||||||
Continuing operations |
$ | 0.08 | $ | 0.29 | ||||
Discontinued operations |
0.00 | (0.00 | ) | |||||
Net income |
$ | 0.08 | $ | 0.28 | ||||
Diluted income (loss) |
||||||||
Continuing operations |
$ | 0.08 | $ | 0.28 | ||||
Discontinued operations |
0.00 | (0.00 | ) | |||||
Net income |
$ | 0.08 | $ | 0.28 | ||||
Weighted average shares of common stock outstanding: |
||||||||
Basic shares |
58,719 | 57,818 | ||||||
Diluted shares |
59,535 | 60,630 | ||||||
Computation of diluted income per share from continuing operations: |
||||||||
Net income from continuing operations |
$ | 4,744 | $ | 16,504 | ||||
Add: Interest and issuance costs related to dilutive convertible debt-net of tax |
| 495 | ||||||
Net income from continuing operations diluted |
$ | 4,744 | $ | 16,999 | ||||
Basic shares |
58,719 | 57,818 | ||||||
Dilutive effect of stock options and restricted stock |
816 | 814 | ||||||
Dilutive effect of the 2023 Notes |
| 1,998 | ||||||
Diluted shares |
59,535 | 60,630 | ||||||
March 31, | December 31, | |||||||
2010 | 2009 | |||||||
Unaudited |
||||||||
Cash and investments securities (including restricted investments) |
$ | 532,821 | $471,895 | |||||
OSI Pharmaceuticals, Inc. and Subsidiaries
Reconciliation From Reported Net Income from Continuing Operations to Non-GAAP Net Income from Continuing Operations and
Reported Diluted Income Per Share to Non-GAAP Diluted Income Per Share
Unaudited
(In thousands, except per share data)
Reconciliation From Reported Net Income from Continuing Operations to Non-GAAP Net Income from Continuing Operations and
Reported Diluted Income Per Share to Non-GAAP Diluted Income Per Share
Unaudited
(In thousands, except per share data)
Three Months Ended March 31, | ||||||||
2010 | 2009 | |||||||
Reported diluted income per common share from continuing operations |
$ | 0.08 | $ | 0.28 | ||||
Adjustments per common share |
0.55 | 0.30 | ||||||
Non-GAAP diluted income per common share from continuing operations |
$ | 0.63 | $ | 0.58 | ||||
Net income from continuing operations |
$ | 4,744 | $ | 16,504 | ||||
Non-GAAP Adjustments: |
||||||||
Site consolidation-related costs: |
||||||||
Restructuring costs |
3,108 | | ||||||
Accelerated depreciation on leasehold improvements* |
1,204 | | ||||||
Total site consolidation-related costs |
4,312 | | ||||||
Equity-based compensation expense |
6,506 | 6,183 | ||||||
Imputed interest related to the application of ASC 470 |
2,935 | 3,448 | ||||||
Amortization of acquired intangibles |
218 | 228 | ||||||
Non-cash tax expense |
2,996 | 9,848 | ||||||
Tender offer related costs |
10,646 | | ||||||
Non-operating impairments |
7,937 | | ||||||
Income tax effect on adjustments |
(700 | ) | (256 | ) | ||||
Non-GAAP net income from continuing operations |
$ | 39,594 | $ | 35,955 | ||||
Computation of Non-GAAP diluted income per common share from continuing operations: |
||||||||
Non-GAAP net income from continuing operations |
$ | 39,594 | $ | 35,955 | ||||
Add: Interest and issuance costs related to dilutive convertible debt-net of tax |
2,298 | 1,490 | ||||||
Non-GAAP net income from continuing operations diluted |
$ | 41,892 | $ | 37,445 | ||||
Computation of Non-GAAP diluted shares: |
||||||||
Basic shares |
58,719 | 57,818 | ||||||
Adjustment to dilutive shares: |
||||||||
Dilutive effect of options and restricted stock |
816 | 814 | ||||||
Dilutive effect of the 2023 Notes |
1,209 | 1,998 | ||||||
Dilutive effect of the 2025 Notes |
3,908 | 3,908 | ||||||
Dilutive effect of the 2038 Notes |
2,167 | | ||||||
Non-GAAP dilutive shares |
66,819 | 64,538 | ||||||
* Represents the impact of shortening the estimated useful lives of leasehold improvements as a result of our
intention to exit certain facilities.