Friday, May 05, 2006

 

Merck Finds "Happy Place"

Merck Well-Positioned to Regain Industry-Leadership Position

 

4/25/2006  - Whitehouse Station, NJ - Merck & Co., Inc. can again be the company that patients and physicians look to first for unmatched excellence, that the medical and scientific communities look to first for inspiration and achievement, and that investors look to first for growth among pharmaceutical companies, said Richard T. Clark, Chief Executive Officer and President, at Merck's Annual Meeting of Stockholders recently.

"We understand the environment in which we are working and the challenges that the environment poses. But we also see the enormous opportunities the environment offers - and we are fully prepared to take advantage of those opportunities. Merck's strategic plan, our 'Plan to Win,' which we announced in December, will enable Merck to regain the leadership position it long enjoyed, if we can execute it flawlessly, every step of the way. Fortunately, the people of Merck have the talent, the will, and the commitment to do exactly that," Mr. Clark told approximately 600 stockholders at the Company's annual meeting at Raritan Valley Community College in North Branch, N.J.

Mr. Clark reviewed for stockholders the Company's current performance and promising drug candidates, and outlined key elements of the Plan to Win. As Merck strives to reclaim its leadership position, Mr. Clark noted that the Company has a solid financial platform on which to build.

Earnings Affirm Financial Strength
On April 20, Merck announced strong financial results for the first quarter of 2006 and raised full-year 2006 guidance. First-quarter earnings per share (EPS) were $0.78, excluding restructuring 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 and position eliminations, and reported full-year 2006 EPS range of $2.02 to $2.16.

The first-quarter results were driven by the performance of ZOCOR and SINGULAIR in the United States and Merck's vaccines, plus the strong performance of the Company's partnerships and alliances.

"These results demonstrate our solid momentum as we move forward in 2006. They also clearly indicate that we are making progress against the goals we outlined in December to return Merck to an industry-leading position," Mr. Clark said.

Mr. Clark told shareholders that Merck remains confident that it can generate compound annualized adjusted revenue growth of between 4 to 6 percent over the next five years, including the Company's share of sales through its joint ventures and partnerships, and that Merck can deliver double-digit compound earnings growth over the next three to five years, excluding restructuring charges and one-time items. Merck expects to return to bottom-line earnings per share growth, on the same basis, next year.

Changing Every Aspect of Merck's Business
Merck's Plan to Win is fundamentally changing every aspect of the business with one exception: Merck's commitment to put patients first, which means always acting in accordance with the highest standards of ethics and values, and never forgetting George W. Merck's vision that medicine is for the people, Mr. Clark told stockholders.

"We are already implementing the five strategic actions that make up the plan: focusing on nine priority disease areas, redefining our drug discovery and development model, working to achieve leadership in emerging pharmaceutical markets, building a new commercial model and creating a lean and flexible cost structure. I am confident in our ability to make this plan a reality," Mr. Clark said.

Mr. Clark highlighted each of the five strategic actions during the meeting.

The first strategic action is the decision to concentrate research and development efforts in nine therapeutic areas: Alzheimer's disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, cancer, pain, and sleep disorders. These areas were selected because of the opportunity Merck believes they provide, both due to the enormous unmet need that exists, and because of the likelihood that the Company can make a real difference in discovering and developing effective, safe and highly desired treatments.

Next, Merck is redefining its discovery and development process to yield new, high-value products more efficiently. Merck needs to be able to move faster and smarter than ever before in keys areas, including responding to the needs of the marketplace, partnering with scientific leadership and key opinion leaders, increasing external sourcing capability, and differentiating medicines in the marketplace.

The third action is creating a new commercial model - a model based on getting patients, physicians, and payers the right information, at the right time, in the right way. The Company is working to increase the productivity of the marketing and sales efforts to promote Merck's products while at the same time fully investing in new product launches. The Company must also continue to demonstrate the unique benefits of Merck's products - benefits that may not be able to be duplicated by competing products.

The fourth component is building a long-term leadership position in emerging pharmaceutical markets around the world. Merck already has a presence in such key markets as China, India, and in parts of Eastern Europe and Russia. The Company is working to expand its presence in these and other key markets that hold the potential for real growth.

The fifth component of the strategy is to create a lean and flexible cost structure. Last November, Merck announced some significant steps to reduce its cost base. This includes selling or closing five manufacturing facilities, two preclinical sites, and a basic research center over the next several years. Merck's total workforce will be reduced by 7,000 positions. To date, approximately 2,900 of those positions have already been eliminated.

"We believe we have the plan needed to give our employees the direction and the ability to make Merck, once again, the most respected and most valued company in the industry. We look forward to the 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 Merck Research Laboratories, provided an update on the progress of Merck's pipeline and highlighted recent accomplishments.

"Merck's pipeline is the strongest it's been in years. And because of changes we began making last year to our research and development model, we are well-positioned to continue to meet our mission of discovering and developing novel medicines that meet unaddressed medical needs," said Dr. Kim.

According to Dr. Kim, it was an outstanding year for research and development 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 the FDA for JANUVIA, a novel investigational treatment for type 2 diabetes, which represents a new way of reducing blood sugar levels to normal levels. In clinical trials, the incidence of hypoglycemia, or low blood sugar, was similar to placebo.

Later this year, the Company plans to file an application for vorinostat, an investigational compound often referred to in the past as SAHA. Vorinostat, which is a result of Merck's acquisition of Aton Pharmaceuticals, has shown great promise in the treatment of cutaneous T-cell lymphoma, a cancer which affects the skin. The product is currently in Phase II.

The third application Merck expects to file in 2006 will be for MK-0517, which is an investigational intravenous medicine related to EMEND, Merck's medicine for the treatment of chemotherapy induced nausea and vomiting. MK-0517 is expected to provide a more convenient way to deliver this drug to patients undergoing chemotherapy.

"Therapies in our pipeline have the potential to literally change the course of medical history. That opportunity is the reason the people of Merck take great pride in what we do. It's why we have great confidence in what we can accomplish in the future. And it's what has been driving our effort to redefine our product discovery and development process over the past several years," said Dr. Kim.

In 2005, Merck took critical steps to strengthen its ability to discover and develop new medicines and vaccines-the decision to concentrate its research and development efforts in nine priority disease areas-while also redefining its discovery and development process. Dr. Kim reviewed in some detail the rationale behind the selection of the nine priority disease areas in which Merck will concentrate its research and resources.

Over the past several years, external alliances, partnerships, and acquisitions have played an important role in increasing the strength of Merck's pipeline. Last year, Merck concluded 44 transactions across a broad range of therapeutic categories.

"By concentrating our efforts, increasing our productivity, increasing our probability of success, increasing our collaborative efforts with the external world, and decreasing the time it takes to discover and develop new drugs, we have every confidence that Merck will regain its leadership position in the industry and in the world of medicine," Dr. Kim concluded.

SOURCE: Merck & Co., Inc.


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