Friday July 24, 9:35 am Eastern Time
Company Press Release SOURCE: Pfizer Inc Pfizer Has 'Unsurpassed Prospects,' McKinnell Tells Analyst Meeting Katen Highlights Major Product Successes; Announces Viagra Application Filed Today in Japan
NEW YORK, July 24 /PRNewswire/ -- Pfizer Inc has ''unsurpassed prospects,'' Henry A. McKinnell, Ph.D., executive vice president, Pfizer Inc, and president, Pfizer Pharmaceuticals Group (PPG), told a meeting of investment community analysts, financial press and guests today.
''Our opportunities as a company are truly unprecedented,'' Dr. McKinnell said, ''whether measured in number, quality or potential financial impact. Furthermore, our capabilities to seize and maximize those opportunities are unequaled in the industry. The resulting equation is both clear and straightforward: unprecedented opportunities multiplied by unequaled capabilities equals unsurpassed prospects.''
Karen L. Katen, executive vice president PPG and president, U.S. Pharmaceuticals, characterized the success of the current portfolio of innovative products, and provided some insights into how the U.S. Pharmaceutical organization plans to extend its momentum beyond 1998.
''Our performance is driven by volume,'' Ms. Katen said. ''The strong underlying demand for our products is evident in new prescription growth. During the first half of 1998, Pfizer outpaced every other competitor in new prescription growth in the U.S.''
''These results are no accident,'' she continued. ''Our ability to continuously grow sales and improve the competitive ranking of our in-line portfolio, while successfully launching new products into an increasingly competitive operating environment, provides powerful evidence of what we consider to be our best-in-class marketing, medical and sales capabilities, and our operational expertise.''
One product she cited was Norvasc, the company's intrinsic once-a-day calcium channel blocker for the treatment of hypertension and angina. Norvasc, she said, is already the largest-selling cardiovascular product in the U.S. and the world. Total prescriptions grew by 22 percent during the first half of 1998 -- nearly three times the growth rate for cardiovascular products as a whole and 11 times the growth rate for calcium channel blockers as a class.
Pfizer co-promotes Lipitor, a cholesterol- and triglyceride-lowering agent, with Warner-Lambert Company [NYSE:WLA - news], which discovered and developed the drug. ''Last year,'' Ms. Katen said, ''the Lipitor introduction was the most successful launch of any product in any class ever in the U.S. This year it is the best selling medicine in its class, and we look forward to continued market share growth in the future.''
The company's two newest products, Trovan and Viagra, were introduced in the U.S. this year. Both have gotten off to remarkable starts, Ms. Katen said. ''After only four months on the market, Trovan, our next-generation quinolone antibiotic, has already broken into the top-10 most-prescribed brand-name antibiotics.''
Viagra, for the treatment of erectile dysfunction, was launched in the U.S. in April, and has achieved breathtaking sales levels for a new product. ''In 14 weeks on the market,'' Ms. Katen said, ''more than 3 million Viagra prescriptions have been written by more than 175,000 physicians.''
''In addition to being highly effective,'' she continued, ''Viagra is also safe when used as directed in the product label. Our post-launch experience, including possible drug interactions, has been entirely consistent with the clinical trial results submitted to the FDA and the product labelling approved by the FDA...and the FDA has affirmed this fact on two separate occasions since the product's introduction. Viagra does not increase the risk of cardiovascular events for patients with cardiovascular disease.''
Ms. Katen told analysts that their projections for Viagra sales should reflect on a number of variables. Without making any projections, she said analysts' forecasts should reflect growing prescriptions over the remainder of the year. She announced that Pfizer today filed for approval of Viagra in Japan.
''While the science behind Viagra is compelling,'' Ms. Katen said, ''the feedback we have heard from patients and partners is even more profound. We've heard from many couples who tell us that restoring lost intimacy has made a real difference in their lives. Viagra is changing many people's lives, and for the better.''
Ms. Katen noted that while the Pfizer success story starts with innovative medicines, the company has been successful in combining great products with great medical and marketing skills; an unwavering focus on meeting customer needs; coordination and customization of marketing and sales efforts; and a superior sales organization.
The Pfizer sales force in the U.S. is the second largest in the industry, but ranks first in productivity, measured by sales calls per sales representative and other metrics, she said. Of the top 10 pharmaceutical products promoted most heavily in the U.S. so far this year, five are Pfizer products. In terms of quality, the Pfizer sales force was ranked first by physicians for the third year in a row, according to an independent survey.
''It is our commitment to field sales as a key driver of our growth and success that has led us to repeatedly invest in additional field resources as our product line has grown,'' Ms. Katen said. ''As our product portfolio continues to expand, with more new products to be introduced in 1999, and no major patent expirations over the next several years, we expect to significantly expand our field organization again, beginning in the fourth quarter of this year.''
One of those expected product introductions is Celebra, which Pfizer will co-promote with the G.D. Searle division of Monsanto. Searle discovered and developed Celebra, which blocks the activity of cyclo-oxygenase 2 (Cox-2), an enzyme responsible for the pain and swelling of the joints associated with arthritis, more selectively than currently available products.
''We anticipate that Celebra will be the first specific Cox-2 inhibitor to reach the market,'' Ms. Katen said. ''Its unique mechanism of action is expected to provide efficacy equivalent to leading currently available therapies, but with substantially improved safety, including no significant impact on blood clotting, or adverse effects in the gastro-intestinal tract.''
Craig Saxton, M.D., executive vice president of Pfizer Central Research, reviewed the regulatory status of, and plans for, Zeldox, an antipsychotic discovered and developed by Pfizer. In June, the FDA informed Pfizer that it would not approve the Zeldox NDA filed last September without additional clinical data, which it believed necessary to answer questions it has related to the observation of a very slight increase in the cardiovascular QTc interval in some patients treated with Zeldox. This effect is seen with many drugs, especially among antipsychotics. Dr. Saxton said the company was planning to agree with the FDA on the parameters of the study, and anticipated the NDA would be able to be refiled late next year. Dr. Saxton also said that the company did not plan to launch Zeldox elsewhere in the world until the new clinical study was completed.
David L. Shedlarz, chief financial officer, reviewed the company's financial performance for the second quarter and first half, which was made public July 9.
''Pfizer had another strong quarter,'' Mr. Shedlarz said, ''featuring high- quality revenue and income growth, as well as investments for future growth. Strong revenue growth was balanced by strong investment in Pfizer's new product portfolio and pipeline during the second quarter. Even with substantial investments in sales, marketing, and research and development, income before taxes grew 42 percent. Net income grew 38 percent, despite an increase in the company's effective tax rate to 29 percent to reflect the higher growth rate in the U.S.
''It's clear that the foundation upon which we're building future growth is very strong indeed,'' Mr. Shedlarz said. ''As we have said in the past, Pfizer's financial performance for the full year will depend on the continued strong performance of new, in-line, and alliance products, as well as the size and timing of our investments, and other factors such as the impact of foreign exchange on revenues and income, and the effective tax rate. We will continue to invest in marketing and sales and in R&D to fully realize the medical and commercial potential of our product opportunities, both near-and long-term.
''In the case of R&D,'' he continued, ''Pfizer expects to spend about $2.3 billion during 1998. Factoring in our major investments for the future, and despite our increased effective tax rate and the unfavorable impact of foreign exchange on revenues and income, we are comfortable with the current range of the majority of analysts' diluted earnings-per-share estimates of $2.05 to $2.10 for the year. This assessment excludes impacts from acquisitions, divestitures, licensing fees, legal settlements, and other unusual items.''
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