25.04.2006 19:30:00
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Merck Well-Positioned to Regain Industry-Leadership Position, CEO Tells Stockholders
"We understand the environment in which we are working and thechallenges that the environment poses. But we also see the enormousopportunities the environment offers - and we are fully prepared totake advantage of those opportunities. Merck's strategic plan, our'Plan to Win,' which we announced in December, will enable Merck toregain the leadership position it long enjoyed, if we can execute itflawlessly, every step of the way. Fortunately, the people of Merckhave the talent, the will, and the commitment to do exactly that," Mr.Clark told approximately 600 stockholders at the Company's annualmeeting at Raritan Valley Community College in North Branch, N.J.
Mr. Clark reviewed for stockholders the Company's currentperformance and promising drug candidates, and outlined key elementsof the Plan to Win. As Merck strives to reclaim its leadershipposition, Mr. Clark noted that the Company has a solid financialplatform on which to build.
Earnings Affirm Financial Strength
On April 20, Merck announced strong financial results for thefirst quarter of 2006 and raised full-year 2006 guidance.First-quarter earnings per share (EPS) were $0.78, excludingrestructuring charges, and reported EPS for the first quarter were$0.69. Merck anticipates full-year 2006 EPS range of $2.32 to $2.40,excluding the restructuring charges related to site closures andposition eliminations, and reported full-year 2006 EPS range of $2.02to $2.16.
The first-quarter results were driven by the performance of ZOCORand SINGULAIR in the United States and Merck's vaccines, plus thestrong performance of the Company's partnerships and alliances.
"These results demonstrate our solid momentum as we move forwardin 2006. They also clearly indicate that we are making progressagainst the goals we outlined in December to return Merck to anindustry-leading position," Mr. Clark said.
Mr. Clark told shareholders that Merck remains confident that itcan generate compound annualized adjusted revenue growth of between 4to 6 percent over the next five years, including the Company's shareof sales through its joint ventures and partnerships, and that Merckcan deliver double-digit compound earnings growth over the next threeto five years, excluding restructuring charges and one-time items.Merck expects to return to bottom-line earnings per share growth, onthe same basis, next year.
Changing Every Aspect of Merck's Business
Merck's Plan to Win is fundamentally changing every aspect of thebusiness with one exception: Merck's commitment to put patients first,which means always acting in accordance with the highest standards ofethics and values, and never forgetting George W. Merck's vision thatmedicine is for the people, Mr. Clark told stockholders.
"We are already implementing the five strategic actions that makeup the plan: focusing on nine priority disease areas, redefining ourdrug discovery and development model, working to achieve leadership inemerging pharmaceutical markets, building a new commercial model andcreating a lean and flexible cost structure. I am confident in ourability to make this plan a reality," Mr. Clark said.
Mr. Clark highlighted each of the five strategic actions duringthe meeting.
The first strategic action is the decision to concentrate researchand development efforts in nine therapeutic areas: Alzheimer'sdisease, atherosclerosis, cardiovascular disease, diabetes, novelvaccines, obesity, cancer, pain, and sleep disorders. These areas wereselected because of the opportunity Merck believes they provide, bothdue to the enormous unmet need that exists, and because of thelikelihood that the Company can make a real difference in discoveringand developing effective, safe and highly desired treatments.
Next, Merck is redefining its discovery and development process toyield new, high-value products more efficiently. Merck needs to beable to move faster and smarter than ever before in keys areas,including responding to the needs of the marketplace, partnering withscientific leadership and key opinion leaders, increasing externalsourcing capability, and differentiating medicines in the marketplace.
The third action is creating a new commercial model - a modelbased on getting patients, physicians, and payers the rightinformation, at the right time, in the right way. The Company isworking to increase the productivity of the marketing and salesefforts to promote Merck's products while at the same time fullyinvesting in new product launches. The Company must also continue todemonstrate the unique benefits of Merck's products - benefits thatmay not be able to be duplicated by competing products.
The fourth component is building a long-term leadership positionin emerging pharmaceutical markets around the world. Merck already hasa presence in such key markets as China, India, and in parts ofEastern Europe and Russia. The Company is working to expand itspresence in these and other key markets that hold the potential forreal growth.
The fifth component of the strategy is to create a lean andflexible cost structure. Last November, Merck announced somesignificant steps to reduce its cost base. This includes selling orclosing five manufacturing facilities, two preclinical sites, and abasic research center over the next several years. Merck's totalworkforce will be reduced by 7,000 positions. To date, approximately2,900 of those positions have already been eliminated.
"We believe we have the plan needed to give our employees thedirection and the ability to make Merck, once again, the mostrespected and most valued company in the industry. We look forward tothe day when we can say - and you will agree - that Merck is back,"Mr. Clark said.
Growth and Progress in Merck's Pipeline
During the meeting, Peter S. Kim, Ph.D., president of MerckResearch Laboratories, provided an update on the progress of Merck'spipeline and highlighted recent accomplishments.
"Merck's pipeline is the strongest it's been in years. And becauseof changes we began making last year to our research and developmentmodel, we are well-positioned to continue to meet our mission ofdiscovering and developing novel medicines that meet unaddressedmedical needs," said Dr. Kim.
According to Dr. Kim, it was an outstanding year for research anddevelopment at Merck. During the past year:
-- Merck received FDA approval for two new products: FOSAMAX Plus D and PROQUAD; while new indications were approved for EMEND and SINGULAIR.
-- Merck filed applications with the FDA for three new vaccines: GARDASIL, the Company's investigational vaccine against cervical cancer; ROTATEQ, its vaccine for infant gastroenteritis (which has already been approved and is launching in the U.S.); and ZOSTAVAX, its investigational vaccine against shingles in older adults.
-- Even as the Company was filing three potentially new products with the FDA last year, new programs were advancing into Phase III of development. Merck currently has six products in late-stage development; in fact, the pipeline continues to grow as every phase of development.
-- In addition, Merck also either has filed or expects to file applications for three new products this year.
Merck recently announced that its filing had been accepted by theFDA for JANUVIA, a novel investigational treatment for type 2diabetes, which represents a new way of reducing blood sugar levels tonormal levels. In clinical trials, the incidence of hypoglycemia, orlow blood sugar, was similar to placebo.
Later this year, the Company plans to file an application forvorinostat, an investigational compound often referred to in the pastas SAHA. Vorinostat, which is a result of Merck's acquisition of AtonPharmaceuticals, has shown great promise in the treatment of cutaneousT-cell lymphoma, a cancer which affects the skin. The product iscurrently in Phase II.
The third application Merck expects to file in 2006 will be forMK-0517, which is an investigational intravenous medicine related toEMEND, Merck's medicine for the treatment of chemotherapy inducednausea and vomiting. MK-0517 is expected to provide a more convenientway to deliver this drug to patients undergoing chemotherapy.
"Therapies in our pipeline have the potential to literally changethe course of medical history. That opportunity is the reason thepeople of Merck take great pride in what we do. It's why we have greatconfidence in what we can accomplish in the future. And it's what hasbeen driving our effort to redefine our product discovery anddevelopment process over the past several years," said Dr. Kim.
In 2005, Merck took critical steps to strengthen its ability todiscover and develop new medicines and vaccines--the decision toconcentrate its research and development efforts in nine prioritydisease areas--while also redefining its discovery and developmentprocess. Dr. Kim reviewed in some detail the rationale behind theselection of the nine priority disease areas in which Merck willconcentrate its research and resources.
Over the past several years, external alliances, partnerships, andacquisitions have played an important role in increasing the strengthof Merck's pipeline. Last year, Merck concluded 44 transactions acrossa broad range of therapeutic categories.
"By concentrating our efforts, increasing our productivity,increasing our probability of success, increasing our collaborativeefforts with the external world, and decreasing the time it takes todiscover and develop new drugs, we have every confidence that Merckwill regain its leadership position in the industry and in the worldof medicine," Dr. Kim concluded.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceuticalcompany dedicated to putting patients first. Established in 1891,Merck discovers, develops, manufactures and markets vaccines andmedicines to address unmet medical needs. The Company devotesextensive efforts to increase access to medicines through far-reachingprograms that not only donate Merck medicines but help deliver them tothe people who need them. Merck also publishes unbiased healthinformation as a not-for-profit service. For more information, visitwww.merck.com.
Forward-Looking Statement
This press release, including the financial information thatfollows, contains "forward-looking statements" as that term is definedin the Private Securities Litigation Reform Act of 1995. Thesestatements are based on management's current expectations and involverisks and uncertainties, which may cause results to differ materiallyfrom those set forth in the statements. The forward-looking statementsmay include statements regarding product development, productpotential or financial performance. No forward-looking statement canbe guaranteed, and actual results may differ materially from thoseprojected. Merck undertakes no obligation to publicly update anyforward-looking statement, whether as a result of new information,future events, or otherwise. Forward-looking statements in this pressrelease should be evaluated together with the many uncertainties thataffect Merck's business, particularly those mentioned in thecautionary statements in Item 1 of Merck's Form 10-K for the yearended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form8-K, which the Company incorporates by reference.
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