-----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, Rs7vxjMDqTB4vxyWM6IfiANPdSUSGkK4b/uB6+MLi1uMu3WH30qiTXsiMdO1daYA yVvQVaQDaaBimosD9rHB9A== 0000950123-05-010728.txt : 20050902 0000950123-05-010728.hdr.sgml : 20050902 20050902172235 ACCESSION NUMBER: 0000950123-05-010728 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050902 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050902 DATE AS OF CHANGE: 20050902 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCHERING PLOUGH CORP CENTRAL INDEX KEY: 0000310158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221918501 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 051068645 BUSINESS ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 BUSINESS PHONE: 9082984000 MAIL ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 8-K 1 y12465e8vk.htm SCHERING-PLOUGH CORPORATION FORM 8-K
 

 
 
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
Date of Report (Date of earliest event reported): September 2, 2005
SCHERING—PLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
         
New Jersey
(State or Other Jurisdiction of
Incorporation)
  1-6571
(Commission File Number)
  22-1918501
(IRS Employer
Identification Number)
2000 Galloping Hill Road
Kenilworth, NJ 07033
(Address of Principal Executive Office)
Registrant’s telephone number, including area code: (908) 298-4000
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))
 
 

 


 

Item 7.01 Regulation FD Disclosure.
Schering-Plough Corporation from time to time issues Frequently Asked Questions and Answers (FAQs) that are believed to be of interest. The most recent FAQs, dated September 2, 2005, are furnished as Exhibit 99.1 to this 8-K and are posted on the Schering-Plough Website at www.schering-plough.com under “investor relations/investor FAQs.”
Schering-Plough undertakes no obligation to update the FAQs and readers should note the date of information when referring to the FAQs or other historical information available on the website.
Item 9.01 Financial Statements and Exhibits
The following exhibits are furnished with this 8-K:
99.1 September 2, 2005 Frequently Asked Questions and Answers
SIGNATURE(S)
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.
Schering-Plough Corporation
By:   /s/ Douglas J. Gingerella
Douglas J. Gingerella
Vice President and Controller
Date: September 2, 2005

 


 

Exhibit Index
The following exhibits are furnished with this 8-K:
99.1 September 2, 2005 Frequently Asked Questions and Answers

 

EX-99.1 2 y12465exv99w1.htm EX-99.1: 9/2/05 FREQUENTLY ASKED QUESTIONS AND ANSWERS EX-99.1
 

Exhibit 99.1
     
 
  September 2, 2005 — Frequently Asked Questions and Answers (FAQ’s)
 
   
 
  From time to time, Investor Relations will provide FAQs on various topics of interest. The following is a compilation of recent FAQs.
 
   
Q
  How is VYTORIN doing after its first year on the U.S. market?
 
   
A
  VYTORIN was launched in the U.S. during August 2004. Since that time, VYTORIN has achieved a new prescription market share of over 6 percent in the U.S. cholesterol treatment market. In recent weeks, VYTORIN new prescription market share has surpassed that of ZETIA, making VYTORIN the 3rd leading prescription product for the treatment of patients with high cholesterol in the U.S. after just one year on the market.
 
In its first year on the market, over 5 million prescriptions for VYTORIN have been dispensed in the U.S.
 
   
Q
  What is the status of ASMANEX in the U.S.?
 
   
A
  Schering-Plough has recently commenced an early experience program with prescribers in the U.S. This program is designed to provide a full month of ASMANEX therapy, as well as educational materials, to those patients who may benefit from using ASMANEX. The Company expects to make a significant quantity of samples available as part of this early experience program. The Company expects that many of the initial patients receiving ASMANEX will receive samples through the early experience program, which may impact prescription levels.
 
   
Q
  Has the agreement with Millennium for INTEGRILIN been completed?
 
   
A
  The closing of the agreement between Schering-Plough Corporation (NYSE: SGP) and Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) to restructure their collaboration for INTEGRILIN in the U.S. became effective September 1, 2005. Under the new relationship, Schering-Plough acquires exclusive development and commercialization rights to INTEGRILIN in the U.S. The agreement was first announced on July 22 and has since cleared federal antitrust review under the Hart-Scott-Rodino Act.
 
   
Q
  Will you give earnings guidance for 2005 or 2006 at your R&D and Product Review meeting in November?
 
   
A
  Currently, Schering-Plough is not providing numeric EPS guidance. Additionally, the Company will not provide numeric EPS guidance at the November R&D and Product Review meeting.
 
   

 


 

     
Q
  Assuming you complete the Consent Decree work by December 31, 2005, how much will your gross margin improve?
 
   
A
  Schering-Plough has not provided guidance on the gross margin. The Company’s gross margin is generally affected by product mix, production volumes, quality and consent decree-related spending, and to some extent foreign currency. Of these, product mix and production volumes have the largest impact on Schering-Plough’s gross margin. Also, as previously stated, the ongoing upgrade of infrastructure and quality systems means that the gross margin is not expected to return to pre-consent decree levels.
 
A number of the Company’s products, including REMICADE, INTEGRILIN, AVELOX, CIPRO and other products, are partnered with other companies. As a result, these products unfavorably affect Schering-Plough’s overall gross margin.
 
The company’s fast-growing cholesterol franchise does not benefit the overall gross margin due to accounting conventions for joint ventures. Consistent with these conventions, Schering-Plough does not record sales of the cholesterol franchise in most markets.
 
In addition, the company’s manufacturing cost base is relatively fixed and Schering-Plough continues to experience lower production volumes in its plants. Efforts to significantly reduce the company’s manufacturing infrastructure involve complex issues. In most cases, shifting products between manufacturing plants can take many years due to construction, revalidation and registration requirements.
 
Due to these factors, the gross margin is not expected to improve significantly simply as a result of the Consent Decree work being completed.
The information in this FAQ contains certain “forward-looking” statements, including statements relating to the market for VYTORIN, the expected availability of ASMANEX, and the potential for gross margin changes. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering- Plough’s forward-looking statements. The forward-looking statements may be affected by general market and economic factors, uncertainties in the regulatory approval process, federal and state regulations and legislation, and other uncertainties described in the company’s Securities and Exchange Commission filings under the heading “Disclosure Notice” including the company’s second quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.

 

-----END PRIVACY-ENHANCED MESSAGE-----