-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F0c5xZiTt4C3W04J9C1U7xjzTnNWZHAsA6wYeeo2UAPiH6v60m2dXEOnczdyTu+e /aS8XTiI04Mug46RnIGSPg== 0000950123-05-013626.txt : 20051114 0000950123-05-013626.hdr.sgml : 20051111 20051114163402 ACCESSION NUMBER: 0000950123-05-013626 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051114 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051114 DATE AS OF CHANGE: 20051114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000729922 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133159796 STATE OF INCORPORATION: DE FISCAL YEAR END: 1204 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 051202062 BUSINESS ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y14780ae8vk.htm FORM 8-K FORM 8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
November 14, 2005
 
Date of Report (Date of earliest event reported)
OSI PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   0-15190   13-3159796
(State or other jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
58 South Service Road
Melville, NY 11747

(Address of principal executive offices)
(631) 962-2000
(Registrant’s telephone number, including area code)
N/A
(Former name or former address,
if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a- 12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


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ITEM 7.01 Regulation FD Disclosure
ITEM 9.01 Exhibits
SIGNATURE
EXHIBIT INDEX
EX-99.1: SCRIPT OF WEBCAST CONFERENCE CALL


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ITEM 7.01 Regulation FD Disclosure
     On November 14, 2005, at 4:30 p.m., OSI Pharmaceuticals, Inc. (“OSI”) will conduct a webcast conference call with investors and analysts. A script of that webcast conference call is attached to this Current Report on Form 8-K as Exhibit 99.1, and incorporated herein by reference.
     This document 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, the challenges and costs of integrating the operations and personnel of Eyetech Pharmaceuticals, Inc. (“Eyetech”) into OSI; reaction of customers of OSI and Eyetech and related risks of maintaining pre-existing relationships of OSI and Eyetech as a result of the merger; the impact of acquisitions and divestitures on the synergies of OSI’s programs; the completion of clinical trials; the FDA review process and other governmental regulation; OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates; competition from other pharmaceutical companies; the ability to effectively market products; and other factors described in OSI’s filings with the Securities and Exchange Commission.
     The information in this Item 7.01 is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of OSI, except as shall be expressly set forth by specific reference in such document.
ITEM 9.01 Exhibits
         
Exhibit No.   Description
  99.1    
Script of webcast conference call to be held on November 14, 2005.

 


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SIGNATURE
     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 hereunto duly authorized.
         
Date: November 14, 2005
      OSI PHARMACEUTICALS, INC.
 
       
 
  By:   /s/ BARBARA A. WOOD
 
       
 
      Barbara A. Wood
 
      Vice President, General Counsel and Secretary

 


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EXHIBIT INDEX
         
Exhibit No.   Description
  99.1    
Script of webcast conference call to be held on November 14, 2005.

 

EX-99.1 2 y14780aexv99w1.htm EX-99.1: SCRIPT OF WEBCAST CONFERENCE CALL EXHIBIT 99.1
 

Exhibit 99.1
The following is a script to be used by Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals, Inc., during a conference call held on November 14, 2005.
Colin Goddard:
Good Afternoon everyone and welcome to today’s brief conference call during which we are going to summarize the Eyetech transaction and provide for you a timetable through which we will communicate the progress of the integration and provide a clear set of goals and guidance for the newly combined company as we enter 2006. Joining me today I have Mike Atieh, our Chief Financial Officer and Kathy Galante, head of IR and PR.
We closed the transaction this morning and Eyetech shareholders will now receive $15 per share in cash and 0.12275 OSI shares for each Eyetech share owned as of the closing date.
We will now begin the process of integrating the Eyetech business into OSI. As Eyetech recently reported, and net of certain one-time charges, the Eyetech business turned profitable in the 3rd Quarter, and we anticipate, following some immediate integration costs, that we will see a cash flow benefit from the transaction in 2006.
This transaction positions OSI as a scientifically strong and financially diversified biotechnology company. The newly combined company is focused in three therapeutic disease areas of significant market potential: oncology, eye diseases and diabetes, and will allow us to effectively leverage our core expertise in drug discovery and development. We now have two major marketed products in Tarceva® and Macugen® and a robust product pipeline offering both new indications for the marketed products and novel therapeutics in all three disease areas.
As investors will have noted from successive Eyetech and OSI press releases last week the closing of the transaction was delayed by two business days. Last week, just three days prior to the anticipated closing of the transaction, Genentech announced top line Phase III data for Lucentis in a second Phase III trial named ANCHOR. Although we expected the ANCHOR study to meet its end-points, the data were impressive; and appropriately, given the concerns that have been expressed by many of our shareholders concerning

 


 

the Eyetech acquisition and the intense scrutiny that has surrounded this transaction, our Board of Directors chose to take the two extra days available to us under our merger agreement with Eyetech to fully digest and debate the potential impact of this new data and other recent developments in the AMD marketplace on the thesis surrounding the acquisition. In addition to the data itself, Genentech also announced that it would be making Lucentis available to all patients in the ANCHOR study and re-affirmed that it would be filing its BLA for Lucentis with the FDA in December and seeking priority review. We now believe that the strength of the Lucentis data increases the likelihood that Genentech will receive priority review and that Lucentis may therefore be launched into the U.S. market in 2006. Should this occur it will inevitably have some impact on our 2006 assumptions for Macugen sales in the U.S. and we believe our Board had a fiduciary obligation to our shareholders to examine these developments fully prior to concluding the transaction. On Saturday our Board met, at length, to accomplish this and unanimously reaffirmed that the closing of the Eyetech transaction was in the best interests of our shareholders.
While we believe that the increased probability of a 2006 Lucentis launch may have some bearing on Macugen sales, we also believe strongly that, as we have previously stated, there is much still to unfold in the emerging wet age related macular degeneration market. Only when the full efficacy and safety profiles of the competitive agents are fully elucidated through extensive clinical trials and with widespread use in the market will we all be able to fully understand the relative benefits of the respective competitive agents in meeting the needs of patients who suffer from this serious disease. We have a healthy respect for the emerging competitive threat posed by the pan-VEGF targeted Lucentis, but we continue to believe that there is a meaningful place in the AMD marketplace for a highly selective VEGF targeted agent like Macugen that has demonstrated, in both clinical trials and through widespread use in the marketplace, solid efficacy in the treatment of wet-AMD — most particularly in early lesions — and has established an outstanding safety profile.
We believe Tarceva and Macugen are two of the most exciting and novel biotech products launched in recent years. With Macugen serving as an important second brand to our flagship anti-cancer product Tarceva, and the combined revenue flows supporting our ability to continue to build our

 


 

portfolio and pipeline, we continue to believe that we have established the strategic foundation from which to build a fine company.
Our focus now switches to execution on that strategy. Sound management and good execution on an integration and operating plan are now the prerequisites to maximizing the assets and strengths we believe to be inherent in the new company. With that in mind, we wanted to share with you a communication plan through which we will keep investors apprised of our integration plan and the goals of the new company as we enter 2006.
The first part of this will be a conference call that we will host at 8:00 am on November 21, 2005 when we will brief investors on the progress of the integration plan and provide a summary of the projected savings that we see emerging through this process of combining two previously public companies into one. Following on from this we intend to host a major research analyst’s day in February in New York during which we will provide a detailed summary of the Company’s strategic and financial goals for 2006 and provide a drill-down into our R&D portfolio and our plans to optimize and develop the Company’s R&D assets and two leading brands Tarceva and Macugen.
We look forward to sharing this information with the investment community on a timely basis as we execute upon our integration and business planning exercise and demonstrate, through our actions, that the Company is en route to a promising future.
Thank you, and I will take a few questions concerning the events of the last few days.

 

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