-----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, MpURUfgc7AalvRQvR8WwHW8Vrlo1Nw/50AG8NEh6JhIxckJfIU5d7xZpfpUZZJBc aMzfd4EtwASkL5gQhxUO0A== 0000950123-03-013599.txt : 20031209 0000950123-03-013599.hdr.sgml : 20031209 20031209153530 ACCESSION NUMBER: 0000950123-03-013599 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20031209 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20031209 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MERCK & CO INC CENTRAL INDEX KEY: 0000064978 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221109110 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-03305 FILM NUMBER: 031044884 BUSINESS ADDRESS: STREET 1: ONE MERCK DR STREET 2: P O BOX 100 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 BUSINESS PHONE: 9084234044 MAIL ADDRESS: STREET 1: ONE MERCK DR STREET 2: PO BOX 100 WS3AB-05 CITY: WHITEHOUSE STATION STATE: NJ ZIP: 08889-0100 8-K 1 y92312ae8vk.htm FORM 8-K FORM 8-K
Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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)     December 9, 2003     

MERCK & CO., Inc.


(Exact Name of Registrant as Specified in Its Charter)

New Jersey


(State or Other Jurisdiction of Incorporation)
     
1-3305   22-1109110

 
(Commission File Number)   (IRS Employer Identification No.)
     
One Merck Drive, PO Box 100, Whitehouse Station, NJ   08889-0100

(Address of Principal Executive Offices)   (Zip Code)

(908) 423-1000


(Registrant’s Telephone Number, Including Area Code)

 


Item 7. Financial Statements and Exhibits
Item 9. Regulation FD Disclosure
SIGNATURES
EXHIBIT INDEX
OPENING REMARKS
CLOSING REMARKS
PRESS RELEASE


Table of Contents

Item 7. Financial Statements and Exhibits

     (c) Exhibits

     
Exhibit 99.1   Opening Remarks given at the 2003 Annual Business Briefing, by Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of the Registrant
     
Exhibit 99.2   Closing Remarks given at the 2003 Annual Business Briefing, by Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of the Registrant
     
Exhibit 99.3   Press release issued December 9, 2003 regarding business briefing to analysts

Item 9. Regulation FD Disclosure

Incorporated by reference are Opening and Closing Remarks given at the 2003 Annual Business Briefing, by Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of the Registrant, attached as Exhibit 99.1 and Exhibit 99.2, respectively. Also incorporated by reference is a press release issued by the Registrant on December 9, 2003, attached as Exhibit 99.3, concerning the Registrant’s business briefing to analysts.

This information is not deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and is not incorporated by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. Additionally, the submission of this report on Form 8-K is not an admission as to the materiality of any information in this report that is required to be disclosed solely by Regulation FD.

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 hereunto duly authorized.

             
    MERCK & CO., Inc.
             
Date: December 9, 2003   By:   /s/ Debra A. Bollwage    
       
   
        DEBRA A. BOLLWAGE    
        Assistant Secretary    

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number   Description

 
99.1   Opening Remarks given at the 2003 Annual Business Briefing, by Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of the Registrant
     
99.2   Closing Remarks given at the 2003 Annual Business Briefing, by Raymond V. Gilmartin, Chairman, President and Chief Executive Officer of the Registrant
     
99.3   Press release issued December 9, 2003 regarding business briefing to analysts

  EX-99.1 3 y92312aexv99w1.htm OPENING REMARKS OPENING REMARKS

 

Exhibit 99.1

Remarks of Raymond V. Gilmartin,
Chairman, President, and Chief Executive Officer,
Merck & Co., Inc.
at the
2003 Annual Business Briefing

December 9, 2003

     Good morning and welcome to Merck. We are pleased to have you with us today.

     We have made several announcements over the past two months that have raised some serious concerns and important questions about Merck. The purpose of this meeting today is to address those concerns and answer those questions.

     As I see it, today we must address three fundamental issues that arise from these developments:

The first is our failure to meet our projected double-digit earnings per share growth for 2003 due to sales shortfalls. This fact is raising questions about the growth potential of our key products and their strength in the marketplace.

The next is our recent announcements that we were discontinuing two products in Phase III clinical trials. At a time when some were already characterizing our pipeline as thin, losing these two products is raising questions about Merck’s long-term growth potential and the strength of our research effort.

These two areas of concern have naturally raised a third question — has the time come for Merck to pursue a large-scale merger or acquisition as a way to create additional shareholder value?

     Underlying all of these questions and concerns is a larger issue — has Merck’s long-standing emphasis on discovering and developing novel medicines finally run its course? Is it time for Merck to modify or change direction?

     I want to begin by addressing this last point first. As we envision the environment in which pharmaceutical companies will be operating in the years ahead, we believe — and we’re hardly alone in this belief — that the companies which develop novel medicines that demonstrably improve the health and well-being of patients will prosper in the years ahead.

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     We’ve seen a growing backlash in the political arena against so-called “me too” drugs — drugs that offer little or no additional clinical benefit over existing therapies. These drugs are criticized for being too expensive given the limited value they provide, and payers increasingly resist paying for drugs that offer little new health care value to patients. In addition, the less novel a product is, the greater the discount the market demands. Today, what payers demand, physicians expect, and patients need are the novel products that Merck has and will continue to produce. This environment plays to what has always been Merck’s greatest strength.

     Merck has a long and distinguished record of scientific excellence, discovering drugs and vaccines that have literally transformed the practice of medicine and saved and improved the lives of millions. Merck’s research and development efforts are, and will continue to be, the foundation of this company. Despite recent setbacks we are pursing the strategy that is right for Merck and in the best interests of our shareholders. Continuing to focus on developing and launching novel medicines and vaccines backed by proven outcomes at competitive prices, aggressively pursuing external alliances, lowering our cost structure and maximizing our in-line franchises will allow us to grow and succeed over the long term. This company has faced setbacks like this in the past, and it has always emerged from them even stronger. We will again.

     Of course, to succeed in the long-term, we must first succeed in the near-term. I strongly believe we are well-positioned for near-term growth — and here’s why.

     Although we will not achieve double-digit EPS growth in 2003, each of our key product franchises are in large and in growing markets. Each of these products rank either number one or two in their therapeutic areas.

     We continue to reinforce our strong competitive position through ongoing clinical and outcomes studies which broaden indications and drive continued growth.

     In addition, our competitive position is further reinforced by the strong relationships we have built with our managed care customers. These relationships stem from Merck’s ability to work with managed care in a way that brings value to payers and patients alike. With our top 31 customers — which represent about 90 percent of the HMO/PBM business — products such as Vioxx, Fosamax, Singulair, Cozaar and Zocor hold exclusive or co-preferred positions on their formularies in the vast majority of cases.

     In addition, we are reducing our cost structure and protecting our margins, without sacrificing manufacturing quality, our compliance culture, necessary levels of promotion and other marketing and sales support for in-line products and upcoming major launches, or our commitment to research.

     Historically, we have looked to our manufacturing operations for cost reductions, and we have been able to achieve significant savings over the years. For example, our ongoing increases in manufacturing productivity have offset product cost inflation. Our strong record of compliance also helps us avoid additional regulatory costs, product supply interruptions or

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launch delays. And the new wholesale distribution program we announced earlier this fall — and which one of the major wholesalers told us sets the industry standard — should free next year’s sales from buying pattern distortion, allowing for even greater manufacturing efficiency.

     In addition, we are looking company-wide — not just at manufacturing — for increased productivity and efficiency. Therefore, we are examining all areas of our operations and all of our infrastructure costs worldwide to find opportunities where we can improve efficiency and save money.

     We are streamlining business processes, eliminating redundancies, outsourcing non-core activities, and leveraging information technology and global procurement. These efforts will enable us to carry out the elimination of the 4,400 positions without compromising our operating standards or growth objectives. These reductions will begin benefiting our bottom line in 2004 and are expected to generate annual savings of $250 to $300 million in 2005 in payroll and benefits alone.

     At the same time, we are increasing our capital efficiency by reducing overall capital project costs, optimizing manufacturing capacity utilization worldwide, and reducing inventories by streamlining our supply chain. These additional capital efficiencies are expected to enhance Merck’s free cash flow by approximately $640 million by 2006.

     All of the steps I’ve just outlined will contribute to growth in our earnings per share in the next several years, as Merck becomes a more efficient operation.

     The next concern I would like to address is the strength of our pipeline. There’s no question that the loss of the two late-stage compounds represents a setback. And setbacks such as these inevitably raise the question: How is Merck managing for the expiration of the patent on Zocor in 2006?

     As we all know, Zocor will face generic competition in the United States in the second half of 2006. This will have a major short-term effect. However, in a larger sense, these patent expirations are a fact of life in our industry, and their timing and impact are somewhat predictable. It is, of course, our goal to continue to show some growth during that period. But, based on our own experience and that of others in the industry, what appears to matter most to investors is how a company, like Merck, rebounds coming out of the patent expiration period.

     Since the market is forward-looking, what investors will be most interested in as we approach the Zocor patent expiration in mid-2006 is this: How well are our in-line products growing? What will we have recently launched? And what products will be at the FDA awaiting approval or close to filing at that time? Today, we will show the continued growth opportunities of our major in-line products, share with greater clarity the pattern of filings we expect from now to 2006 and, finally, discuss what areas we are focused on in early research and how we are accelerating our development efforts to bring new products forward.

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     So, as we look to 2006, when Zocor goes off patent, the question is: What will our pipeline look like?

     We expect to be in the launch phase of two new products — Zetia/Zocor and Arcoxia — and expect to be filing for a number of others in the run-up to 2006. Now here are some of the details.

     Before the end of the year, we will have submitted two important new products with the Food and Drug Administration. Last quarter, from our partnership with Schering Plough, we filed with the FDA our new Zetia/Zocor combination for lowering cholesterol. And before the month is out, we expect to resubmit an expanded application for Arcoxia, our newest coxib.

     The Zetia/Zocor combination is the first product to reduce cholesterol by targeting both its production in the liver and its absorption in the intestine. This represents a new approach to treating high cholesterol, a true innovation in patient care.

     We are on track to resubmit an expanded NDA this month for Arcoxia, our newest coxib, for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea, acute gouty arthritis and ankylosing spondylitis. No other coxib has indications for acute gouty arthritis, ankylosing spondylitis, and chronic low back pain. Arcoxia, which is highly effective in relieving pain, has already been successfully launched in 38 countries around the world. We anticipate a successful launch in this country once approval is granted.

     These two products have significant sales potential, and we expect them to make substantial contributions to earnings.

     Over the course of the next three years, we also expect to file or launch several other medicines or vaccines that hold significant promise in the prevention of human papillomavirus, shingles and rotavirus, and the treatment of diabetes.

In 2005, we expect to file for approval of a vaccine for human papillomavirus, which is the primary cause of cervical cancer, the second-leading cause of cancer deaths in women, taking the lives of more than 200,000 women each year. More than 30 million young and adult women in this country alone are at risk for developing an HPV infection, which our new vaccine is designed to prevent. This vaccine, if approved, will make a significant difference in their health and their lives.

That same year, we expect to file a vaccine for shingles, a painful condition that afflicts one million adults every year in the United States. Also in 2005, we anticipate filing an application for our rotavirus vaccine. Rotavirus-induced infant diarrhea currently causes the hospitalization of more than 55,000 American children under the age of five every year.

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In 2006, we anticipate filing for approval for the DP-IV inhibitor for diabetes, which will help diabetics manage their disease with far fewer side effects. We expect that this new product will be better tolerated by patients, will not lead to weight gain — and may assist in weight loss — and will not produce edema. With 5 percent of the U.S. population living with diabetes, it will be a welcome addition to our product line.

And next year, in 2004, we expect to submit Proquad for approval by the FDA. Proquad adds chicken pox to the measles, mumps, and rubella vaccine, thereby increasing the number of children who will be immunized against chicken pox.

     Looking further down the pipeline to earlier phases, our scientists are working in a significant number of disease areas to treat such ailments as Alzheimer’s disease, obesity, respiratory disease, coronary heart disease, and rheumatoid arthritis. In addition to working in these important areas, we are also working on novel and effective approaches to accelerating drug development and improving the probability of success of our internal R&D efforts. These efforts will maximize our research investment at every stage of the pipeline.

     While we are enhancing our internal research capabilities, we also are mindful that valuable scientific work is being done by other pharmaceutical and biotech firms. That is why we have completely rethought and expanded our approach to external collaborations and relationships. We see them as more than just a business development or licensing opportunity. Instead, we’re pursuing them as new scientific initiatives — initiatives that will lead to the novel new medicines the market demands.

     In recognition of this, in 2001, we completely transformed our approach to external collaborations. We created an external research team and charged it with expanding and improving our external relationships by making our internal process for entering into and managing our partnerships more effective. This effort has made a real difference.

     In 1999, for example, we completed just 10 deals with external partners. So far this year, we have completed more than 40 transactions — including three in the last two weeks alone. We have another 80 potential opportunities in detailed review. We are pursuing partnerships across the entire continuum of scientific possibilities — from early research to late stage development. They add value to our pipeline and will contribute to our growth. They will, in short, increase shareholder value.

     In the context of these external alliance opportunities, I also want to make note of Merck’s solid financial position. Our strong financial profile means we have the resources we need to fully fund our research and development activities — both internal and external, support our in-line products and maximize upcoming product launches. It also allows us to provide substantial cash returns to our shareholders — an average of more than $6 billion a year, every year from 2000 to 2002. This is the sort of financial health on which a strong future is built.

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     Now, turning to the merger question. As I have just mentioned with respect to our external partnerships, we are constantly looking for ways in which we can deliver increased value to our shareholders. And we have found that we can meet that goal through external alliances that make sense long-term for Merck and its shareholders. Our partnership with Schering-Plough on Zetia and now on Zetia/Zocor, and our most recent alliances with such firms as GenPath, Neurogen, Amrad, and Actelion, are all good examples of this.

     When looking at any potential external alliance or acquisition of any size, we always take a hard-headed, pragmatic look at what the possible benefits and costs of the alliance or acquisition would be. When looking at a large-scale merger, with all that entails, we have to be certain that it would bring significant additions to our pipeline and would add to long-term growth. It would have to, in short, meet the same criteria we use to evaluate any potential licensing or acquisition opportunity. We have consistently found that a large-scale acquisition or merger does not meet those criteria. A large-scale merger would provide, at best, a short-term boost with an expensive long-term cost. That’s not an appropriate trade-off.

     Before I wrap up this part of our presentation, I want to briefly touch on two more areas that have made Merck a more focused and stronger company today than it was a year ago.

     Earlier this year, we completed the successful spin-off of Medco. This spin-off has not only brought real value to our shareholders, it also has restored Merck to “pure focus” on pharmaceutical research. In addition, Merck now owns 99.4 percent — and will soon completely own — Banyu Pharmaceuticals, one of Japan’s top 10 pharmaceutical companies. These two actions make Merck a more focused pharmaceutical research company and give us a stronger position in Japan, the world’s second largest market.

     I should also mention that the new Medicare prescription drug benefit, which President Bush signed yesterday, supports pharmaceutical innovation because it is based on competition. As more seniors — as many as 12 million more — have greater access to prescription drugs through Medicare, we will have the opportunity to compete to broaden our customer base. Based on our proven track record in both securing formulary access and in increasing our market share in managed care, I believe this is a competition for which we are well-positioned.

     Over the past couple of years, we have taken a number of significant actions that have taken us in the direction of our long-term growth objectives. We continue to fully fund the research that is necessary to drive Merck’s long-term growth. We are revamping and expanding our external partnership and licensing activity to strengthen our scientific capabilities and pipeline. We are reducing our cost structure and continue to look for even greater savings and efficiencies. We have changed our wholesale distribution program to achieve even greater manufacturing productivity. We have successfully spun-off Medco. And we have strengthened our position in Japan.

     These actions will pay substantial dividends, both literally and figuratively, in the years ahead.

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     In just a moment, I will turn the program over to our next speakers, who will cover, in greater depth, the points I have just made. But before I do, I’d like to recap for you what we believe will drive our growth.

One — Merck has strong franchises that will continue to contribute to near-term revenue and earnings growth;

Two — we are successfully lowering our cost structure, which will contribute to the growth of our earnings;

Three — between now and 2006 we expect to launch or file important, novel products that hold significant potential for future sales and earnings growth;

Four — our earlier phase pipeline consists of promising novel mechanisms in important areas of health, including diabetes, Alzheimer’s, HIV, and obesity, and we are working in those areas broadly and deeply;

Five — our external collaborations are making important contributions to our pipeline; and

Six — we are in a strong, solid financial position.

     So, again, thank you for being with us today.

     Now I am pleased to turn the floor over to an outstanding scientist and leader, the president of Merck Research Labs, Dr. Peter Kim.

FORWARD LOOKING STATEMENTS

     These remarks contain “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in these remarks should be evaluated together with the many uncertainties that affect our businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2002, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference.

7 EX-99.2 4 y92312aexv99w2.htm CLOSING REMARKS CLOSING REMARKS

 

Exhibit 99.2

Closing Remarks of Raymond V. Gilmartin,
Chairman, President, and Chief Executive Officer,
Merck & Co., Inc.
at the
2003 Annual Business Briefing

December 9, 2003

     Before we open the floor for your questions, I want to again thank you for being with us today and for your interest in Merck. I also want to thank my colleagues, Peter Kim, Brad Sheares, Judy Lewent, and Dick Clark for their presentations today.

     Over the past several hours we have tried to lay out for you why we believe Merck is on the right path for future growth, both in the near-term and the long-term. We recognize that recent announcements that we would not meet our double-digit earnings per share target and that we were discontinuing two late-stage clinical trials have raised concerns within the investment community. I hope we have addressed those concerns today.

     Merck’s senior management team is confident that we have in place the fundamental ingredients for future success.

     Over the past couple of years, we have taken a number of significant actions that have taken us in the direction of our long-term growth objectives. We continue to fully fund the research that is necessary to drive Merck’s long-term growth. We are revamping and expanding our external partnership and licensing activity to strengthen our scientific capabilities and pipeline. We are reducing our cost structure and continue to look for even greater savings and efficiencies. We have changed our wholesale distribution program to achieve even greater manufacturing productivity. We have successfully spun-off Medco. And we have strengthened our position in Japan.

     In closing I’d like to summarize some of the key factors that will drive Merck’s future growth:

One — Merck has strong franchises that will continue to contribute to near-term revenue and earnings growth;

Two — we are successfully lowering our cost structure, which will contribute to the growth of our earnings;

Three — between now and 2006 we expect to launch or file important, novel products that hold significant potential for future sales and earnings growth;

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Four — our earlier phase pipeline consists of promising novel mechanisms in important areas of health, including diabetes, Alzheimer’s, HIV, and obesity, and we are working in those areas broadly and deeply;

Five — our external collaborations are making important contributions to our pipeline; and

Six — we are in a strong, solid financial position.

     Again, thank you for being with us today. Now we would be happy to take your questions.

FORWARD LOOKING STATEMENTS

     These remarks contain “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in these remarks should be evaluated together with the many uncertainties that affect our businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2002, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference.

2 EX-99.3 5 y92312aexv99w3.htm PRESS RELEASE PRESS RELEASE

 

Exhibit 99.3

             
Media Contacts:   Tony Plohoros   Investor Contact:   Mark Stejbach
    (908) 423-3644       (908) 423-5185
             
    Anita Larsen        
    (908) 423-6022        

Merck Strategy in Place to Deliver Long-Term Shareholder Value

  Ezetimibe/Simvastatin Filing Accepted by the FDA in November

  Company on Track to Resubmit NDA for ARCOXIA This Month

  FDA Submission for Three Novel Vaccines Anticipated in Second Half of 2005

  Early-Stage Research Programs Span 28 Therapeutic Categories

  Merck Continues Aggressive Focus on External Alliances; Completes More than 40 Deals in 2003

  Cost-Reduction Program Continues; Elimination of 4,400 Positions to be Complete in 2004

  Major In-Line Franchises Performing Well; Merck Products No. 1 or 2 in Sales in Large Therapeutic Categories

WHITEHOUSE STATION, N.J., Dec. 9, 2003 — Merck remains committed to its strategy of discovering and developing novel medicines and vaccines and is confident in its ability to drive long-term shareholder value, Merck & Co., Inc. Chairman, President and CEO Raymond V. Gilmartin told more than 300 securities analysts and institutional investors today at the company’s Annual Business Briefing.

     “Merck’s research and development efforts are, and will continue to be, the foundation of this company. Despite recent setbacks, we are pursuing the strategy that is right for Merck and in the best interests of our shareholders,” Mr. Gilmartin said.

     “Today, what payers demand, physicians expect and patients need are the novel products that Merck has and will continue to provide,” Mr. Gilmartin added. “Continuing to focus on developing and launching novel medicines and vaccines backed by proven outcomes at competitive prices, aggressively pursuing external alliances, lowering our cost structure and maximizing our in-line franchises will allow us to grow and succeed over the long term.

     “Earlier this year, we completed the successful spin-off of Medco Health Solutions, which has restored Merck to a ‘pure focus’ on pharmaceutical research. In addition, Merck now owns 99.4 percent — and will soon completely own — Banyu Pharmaceuticals, one of Japan’s top 10 pharmaceutical companies. These two actions make Merck a more focused pharmaceutical research company and give us a stronger position in Japan, the world’s second largest market.”

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     Last month, the U.S. Food and Drug Administration (FDA) accepted the filing of a New Drug Application (NDA) for an ezetimibe/simvastatin tablet. The investigational cholesterol-lowering medicine is being developed for the reduction of elevated cholesterol levels (hypercholesterolemia). The application was submitted by Merck/Schering-Plough Pharmaceuticals in September.

     If approved, ezetimibe/simvastatin would be the first product to reduce cholesterol through dual inhibition by targeting both cholesterol production in the liver and absorption in the intestine. Ezetimibe/simvastatin is a single tablet that contains the active ingredients of the cholesterol-lowering drugs ZETIA (ezetimibe), which inhibits cholesterol absorption, and ZOCOR (simvastatin), which reduces cholesterol production in the liver.

     Merck is on track to resubmit an expanded NDA for ARCOXIA, its newest coxib, to the FDA this month for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea, acute gouty arthritis and ankylosing spondylitis. No other coxib currently has indications for ankylosing spondylitis, acute gouty arthritis or chronic low back pain. ARCOXIA has been launched in 38 countries worldwide in Europe, Latin America and the Asia-Pacific region.

Developing and Launching Novel Medicines and Vaccines

     In addition to the 2003 submissions, Merck has novel vaccine candidates and a diabetes drug in its late-stage pipeline. The company expects to submit a Product License Application (PLA) to the FDA for its PROQUAD vaccine, a pediatric combination vaccine for measles, mumps, rubella and chicken pox, in the second quarter of 2004. Merck expects to file PLAs with the FDA for three novel vaccine candidates in the second half of 2005: a human papillomavirus (HPV) vaccine; a shingles (zoster) vaccine; and ROTATEQ, a vaccine for rotavirus-induced infant diarrhea.

     Merck’s investigational HPV vaccine has the potential to be the first vaccine to prevent HPV infection and is expected to have the broadest HPV coverage in vaccines currently known to be in development. HPV infection can lead to the development of cervical cancer, which is the second-most common cancer in women. Cervical cancer impacts approximately 470,000 women each year and leads to more than 200,000 deaths. An estimated 30 million adolescents and adult females in the United States are at risk for developing HPV infection.

     Enrollment in Merck’s large Phase III quadrivalent HPV vaccine program is complete, with approximately 17,000 subjects enrolled. The HPV vaccine is expected to reduce the risk of HPV infection and the associated development of cervical cancer and genital warts. HPV 16 is

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one of the more serious forms of HPV and is associated with cervical cancer deaths. Merck’s Phase II proof-of-concept study with an HPV 16 vaccine showed 100-percent efficacy. The company is confident that competing intellectual property claims will not delay the HPV program.

     Enrollment in Merck’s large Phase III program for a zoster vaccine is complete. The vaccine is being developed for the prevention of shingles, a painful condition, which affects up to 1 million adults each year in the United States and is caused by the reactivation of the chicken pox virus.

     Each year, rotavirus-induced infant diarrhea leads to more than 500,000 physician visits and 50,000 hospitalizations in the United States and causes more than 400,000 infant deaths in the developing world. Currently, no rotavirus vaccines or anti-viral treatments exist for the prevention of rotavirus. Merck’s Phase III trial for ROTATEQ is under way with more than 60,000 infants enrolled.

     The company is also studying a DP-IV inhibitor, a glucose-lowering mechanism used alone and in combination for the treatment of Type II diabetes. The number of people suffering from Type II or Non-Insulin Dependent Diabetes Mellitus today in major pharmaceutical markets is 40 million and that total is expected to more than double to 90 million by 2015. Merck plans to enter Phase III with this investigational compound in the second quarter of 2004 and expects to submit an NDA to the FDA in 2006.

     In addition to reviewing the late stage pipeline, Peter S. Kim, Ph.D., president of Merck Research Laboratories, outlined the company’s preclinical and Phase I and II programs during the meeting. Merck’s research programs, which span 28 therapeutic categories, focus on the development of novel medicines that can address large, unmet medical needs.

     “When you look at the Merck pipeline, from preclinical to Phase III,” Dr. Kim said, “you can see the breadth and depth of our work in the areas of diabetes, obesity, Alzheimer’s disease, respiratory disease, coronary heart disease, rheumatoid arthritis and vaccines. We are pleased with the developments in our early stage pipeline and with the new technologies that give us the potential to move compound candidates into later stages for development faster than before. For example, we expect to move our DP-IV candidate from preclinical to Phase III in just over two years, compared with the industry average of just over four years.”

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Aggressively Pursuing External Alliances

     Merck supplements its internal research with an aggressive licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds. Since early 2002, the company has executed more than 80 transactions, including recent deals with Genpath, for cancer; Amrad, for respiratory disease; Neurogen, for pain; and Actelion, for cardiovascular disease. To date this year, Merck has completed more than 40 deals, compared to 10 in 1999, and has approximately 80 opportunities currently in detailed review.

     Merck evaluates all potential transactions on their ability to enhance the company’s pipeline and long-term growth. “We have consistently found that a large-scale acquisition or merger does not meet those criteria,” Mr. Gilmartin said. “A large-scale merger would provide, at best, a short-term boost with an expensive long-term cost. That is not an appropriate trade-off.”

Lowering the Company’s Cost Structure

     Merck recently accelerated its efforts to fundamentally lower its cost structure through company-wide initiatives. In October, Merck announced the reduction of 4,400 positions, which is expected to be completed in 2004. These reductions are currently under way and, when complete, are expected to generate annual savings of $250 to $300 million starting in 2005.

     In addition, on Dec. 1, the company implemented a new distribution program for U.S. wholesalers, which is intended to moderate the fluctuations in sales currently caused by wholesaler investment buying and improve efficiencies in the distribution of Merck pharmaceutical products.

     By reducing infrastructure costs worldwide, improving the efficiency of capital investments and reducing in-line inventory levels, Merck expects to increase its free cash flow. The company’s capital efficiency initiative is anticipated to improve its capital spending profile through 2006, with average annual capital spending between 2003 and 2006 estimated to be less than $2 billion, compared to $2.6 billion per year in prior years. The company’s new wholesaler distribution program and integrated inventory management strategy is expected to drive a 20-percent reduction in inventory months of supply through 2006 and a cumulative cash flow benefit of more than $300 million during that time.

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Maximizing In-Line Franchises

     Each of Merck’s current products ranks either No. 1 or 2 in sales across large therapeutic areas. This success has been — and is expected to be — driven largely by Merck’s focus on developing novel medicines and demonstrating their value through proven health outcomes.

     Worldwide sales of SINGULAIR, a once-a-day oral medication indicated for the treatment of chronic asthma and the relief of symptoms of seasonal allergic rhinitis, are being driven by strong performance in both the asthma and allergic rhinitis markets. SINGULAIR is the No. 1 asthma controller in terms of total prescriptions in the United States and is the most widely used medicine of its kind (leukotriene antagonist) in the world. Merck expects to submit applications for additional indications to the FDA for perennial allergic rhinitis, prevention of exercise-induced bronchospasm, respiratory syncytial virus and acute asthma between 2004 and 2006.

     FOSAMAX, the most-prescribed medicine worldwide for the treatment of postmenopausal, male and glucocorticoid-induced osteoporosis, maintains strong class leadership in the United States and is the market leader in Europe. Merck expects to launch an oral solution for FOSAMAX during the first quarter of 2004, which would offer patients an alternative to a tablet.

     Total U.S. prescription growth for ZOCOR, the only statin proven to reduce the risk of heart attacks and stroke in people with heart disease and diabetes, regardless of cholesterol level, accelerated following the results of the landmark Heart Protection Study. Merck maintained or improved ZOCOR’s formulary status with all key managed care customers in 2003.

     COZAAR/HYZAAR is the No. 1 AIIA in Europe and maintains the No. 2 position in terms of sales in the U.S. market. Merck expects continued growth from COZAAR/HYZAAR resulting from the landmark Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) and Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan (RENAAL) studies.

     The launch of ZETIA, the cholesterol absorption inhibitor from Merck/Schering-Plough Pharmaceuticals, has been highly successful. To date, more than 4 million prescriptions for ZETIA have been filled and the product has a well-established safety and efficacy profile.

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     In terms of sales, VIOXX holds the No. 2 position in the competitive U.S. coxib market and is the No. 1 coxib in the European market. Merck has filed sNDAs with the FDA for an indication for migraine and juvenile rheumatoid arthritis. If approved, these uses are expected to enhance the efficacy profile of this product.

     Sales of Merck’s hospital and specialty products, including PROSCAR, CANCIDAS, and EMEND, totaled more than $3.1 billion through the third quarter of 2003 and contributed significantly to Merck’s revenues. Merck believes there are significant opportunities for future growth of these products as a result of new and potential indications.

Maintaining a Strong Financial Profile

     In presenting the company’s financial overview, Judy Lewent, executive vice president, chief financial officer and president, Human Health-Asia, said, “Merck’s strong financial profile enables the company to fully fund research and development, aggressively focus on external alliances, support our in-line products and maximize upcoming launches while providing significant cash returns to shareholders.” From 2000 to 2002, Merck returned to shareholders, on average, in excess of $6 billion annually through a combination of dividends and treasury share repurchases, totaling over 85 percent of net income for that period.

     The company stated on Dec. 3, that it anticipates reported earnings per share (EPS) from continuing operations for 2003 of $2.90 to $2.95. This range includes the impact of the elimination of positions consistent with the company’s program to lower its cost structure as well as a new distribution program for U.S. wholesalers, both of which were discussed in the company’s third quarter sales and earnings release. Assuming the new distribution program is fully effective, the impact on product sales is likely to be at the higher end of the $650 to $750 million range previously disclosed, and therefore, 2003 EPS is likely to be at the lower end of the $2.90 to $2.95 range. Details on the income statement items forecasted on Oct. 22, can be found in the company’s third quarter sales and earnings release, which was filed with the Securities and Exchange Commission as an exhibit to a Form 8-K on the same day.

     For 2004, as Merck reported on Dec. 3, the company expects full-year 2004 EPS of $3.11 to $3.17. The actions that the company announced in the fourth quarter of 2003 to lower its cost structure, including the elimination of positions, will continue in 2004. Restructuring charges related to the 2004 actions are expected to reduce full-year 2004 income from continuing operations before taxes by $75 to $125 million. The $3.11 to $3.17 EPS guidance for 2004 given above includes the effect of these restructuring charges. Details on the 2004 guidance forecasted on Dec. 3 can be found in the company’s press release, which was filed with the Securities and Exchange Commission as an exhibit to a Form 8-K on the same day.

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About Merck

     Merck & Co., Inc. is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

Forward-Looking Statement

     This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect our businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2002, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference.

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