THE WALL STREET TRANSCRIPT

 

Questioning Market Leaders For Long Term Investors


BRIAN GALLAGHER - COLLAGENEX PHARMACEUTICALS INC (CGPI)
CEO Interview - published 07/08/2002

DOCUMENT # PAX638

BRIAN M. GALLAGER, PhD, is the Chairman, President and Chief Executive
Officer of CollaGenex Pharmaceuticals, Inc., and has been with the
company since 1994. Dr. Gallagher previously was employed by Bristol-
Myers Squibb between 1988 and 1994 in a number of executive positions in
strategic planning, business development, marketing and as President of
Squibb Diagnostics, a $350 million division. Prior to Bristol-Myers,
between 1978 and 1988, Dr. Gallagher held a number of research,
development, marketing and business management positions with the
pharmaceuticals division of E.I. du Pont de Nemours. He began his career
in 1974 in the Chemistry Department of the Brookhaven National
Laboratory as a research scientist. He currently also serves on the
Board of Directors for Adams Laboratories, a privately held, specialty
pharmaceutical company in the respiratory medicine field. 

SECTOR - BIOTECHNOLOGY

TWST: Would you begin with a brief historical sketch of CollaGenex and an overview of the things you're doing now? Dr. Gallagher: CollaGenex was founded just over 10 years ago in 1992 based on technology that derives from the State University of New York at Stony Brook. It involved the discovery that a certain class of well- known antibiotics ' namely, the tetracyclines ' had properties that were unique and distinct from their anti-microbial properties. These distinct properties include the ability to inhibit the inflammatory cascade and the destruction of the connective tissue in a wide range of acute and chronic diseases. This forms the platform for the company's fundamental IMPACS' (Inhibitors of Multiple Proteases and Cytokines) technology. Our lead product, which is derived from the IMPACS technology, is called Periostat', and it is the first and only pill-based systemic therapy for treating adult periodontitis, more commonly called gum disease. We developed this product internally and launched it to the professional dental market in 1998. We have a 120-person professional detailing force, and to date, over 2 million prescriptions have been filled since launch. Periostat continues to gain increased acceptance by the dental community and it is the first and only oral prescription periodontal drug to receive the Seal of Acceptance by the American Dental Association. Although we originated in the dental pharmaceutical area, as we'll be talking about later, we are a diversified specialty pharmaceutical company that is rapidly moving into both the dermatology and the oncology areas. TWST: And there's no other product out there that is comparable to Periostat? Dr. Gallagher: That's correct. Periostat is the only pill-based therapy. There are other pharmaceutical products for treating adult periodontal disease, primarily locally-applied antimicrobial (LAA) products. We market an LAA under an exclusive license from Atrix Laboratories, and it is called Atridox'. It is a locally applied liquid anti-microbial agent that is administered into the pocket between the tooth and the gum tissue. When in place, the liquid solidifies and releases high levels of the antibiotic doxycycline over a two-week time period, which kills the bacteria that initiates this whole process. It's not a competitive product. It's actually complementary to Periostat since it works by a different mechanism of action. However, Atridox does have two other competing products. One is a product from Dexcel Pharma, called Periochip, which is another locally applied anti-microbial, and the other is a product called Arestin, being marketed by OraPharma. However, Atridox has by far the strongest clinical data and the only LAA with an FDA-approved claim for improved attachment level (between the gums and the teeth). TWST: Roughly how many people in this country have the kind of gum disease that can be dealt with by Periostat? Dr. Gallagher: With respect to periodontal disease, it's estimated that somewhere around 67 million Americans, or one out of every three adults, have some form of the disease. About 25 million people of those affected by the disease have moderate to more severe disease, which involves deep pocketing around the tooth and some bone loss. It's a very common disorder ' one of the most common disorders there is. So the market potential is very large for innovative therapies. As I've said, Periostat is the only pill-based therapy that has ever been conceived for this purpose. So we're in a very good position. TWST: Attitudes today seem to favor you in that a lot of people accepted things that were wrong with their teeth and gums in the past and they don't want them to be that way anymore. Dr. Gallagher: You're exactly right. The other factor that plays very well for the future of CollaGenex and for our products is that the aging population ' the so-called baby boomer population ' has a very different attitude toward health care than even a generation ago. The vast majority of people who are now turning 50 years of age, unlike a generation ago, still have their teeth and want to keep them. They are willing to accept new approaches, such as taking medications, if they believe that it will actually help them to keep their teeth. This is not only for cosmetic reasons but also for health reasons. There have been several reports, both in the scientific literature and in the popular press over the last couple of years, where researchers have reported that people who have periodontal disease ' particularly periodontal disease that's poorly managed ' are frequently at much higher risk to develop certain cardiovascular problems such as heart attacks and strokes. They also have a much higher predisposition to develop diabetes and osteoporosis. In females, there's a much higher tendency for them to give premature birth to infants. There are a number of disorders that have become linked with periodontal disease. I think people are becoming increasingly aware of that, realizing that the worst thing that could happen may not just be that you would lose your teeth; you might be putting yourself at risk for something far more serious. TWST: It's an amazing connection, I must say. Dr. Gallagher: A lot of these studies have been done retrospectively, where people went back and looked at populations of people who were diagnosed with periodontal disease, and then experienced the incidence of heart attacks in this population versus individuals without periodontal disease. It's very difficult to do a prospective study. A number of people have looked at this area now, and I think there probably is a correlation between these diseases. TWST: I've heard of cases where severe gum problems occurred because something went wrong with implants. Does that occur very often? Dr. Gallagher: It does occur and is not uncommon. In fact, although Periostat is not approved for treating a condition called peri- implantitis, which is periodontitis associated with dental implants, dentists, oral surgeons and periodontists have successfully prescribed Periostat for that purpose. TWST: Would you explain what you're doing outside the dental area? Dr. Gallagher: Our interest in dermatology derives largely from a serendipitous discovery. After Periostat had been on the market for several months, we began hearing numerous anecdotal reports of patients who were taking Periostat for their gum disease who were reporting dramatic improvements in their dermatological conditions, principally acne and/or rosacea. At first we were skeptical that there could be a real connection between Periostat and these improvements, so last year we conducted a 60-patient double-blinded, placebo-controlled clinical trial to evaluate Periostat versus placebo in patients with mild to moderate acne. What we discovered was that, indeed, Periostat was highly effective in reducing the number of comedones, also known as blackheads, and inflammatory lesions in these patients, who experienced on average a greater than 50% reduction in comedones and inflammatory lesions. The reason we're excited about this discovery is that Periostat has already been approved by the FDA and is on the market. Safety has been fully established. Therefore, we are planning to conduct a larger clinical trial and submit that data to the FDA to seek additional indications for applications in dermatology. We have been working with the thought leaders in dermatology on the design and management of our clinical trials, and they have expressed great enthusiasm about the prospect of a drug to treat acne and rosacea that is efficacious with virtually no side effects. As a part of our strategy in dermatology, we're also actively seeking to in-license existing dermatology products so we can start building a commercial presence in the dermatology market. In February, we licensed a novel drug delivery technology, named RestoradermTM, which is designed to enhance the dermal delivery of a variety of active ingredients and will form the basis for a proprietary and differentiated portfolio of topical dermatological pharmaceuticals. The number of people suffering from acne and rosacea is estimated to be somewhere between 15 million and 20 million people. I suspect that's underestimated. Last year $1.2 billion was spent in prescription pharmaceuticals to treat acne and rosacea. That number increased 16% in 2001 over the previous year. that We're quite excited to be able to participate in this large and rapidly growing segment. TWST: What is rosacea? Dr. Gallagher: Rosacea is another inflammatory skin condition, mostly confined to the face and upper-body, which is characterized by reddening followed by the appearance of inflammatory lesions, typically on the cheeks and the nasal area. As the disease progresses, the patient develops lesions that look very much like acne. However, the disease occurs in middle-aged people, not in adolescents or in young people typically seen with acne. Rosacea, in its final stages, can produce a permanent disfigurement. Acne has two patient populations. The first includes patients who are in their pre-teens through their early 20s. The second patient population are women of childbearing age, particularly those who undergo wide hormonal swings from using oral contraceptives. This actually is the largest growing segment of the acne market ' the middle-aged female population. TWST: What do you worry about? What obstacles or impediments could there be to your success? Dr. Gallagher: Even though Periostat has been on the market for three years, a pill-based therapy is still a relatively new concept and approach to the treatment of this disease. One can never predict with certainty what the market acceptance of a novel therapy will be. From a competitive standpoint, there is nothing I can foresee at this point that would directly affect us. The dermatology area is a more crowded segment. There are a number of companies, large and small, participating in this market. But again, Periostat appears to be efficacious in treating acne with virtually no side effects. That suggests that the product can be taken over long periods of time with an outstanding safety record. I think that we're in a very strong competitive position as far as that goes. TWST: What are your feelings about acquisitions, joint ventures, partnerships, etc.? Dr. Gallagher: We would view any of these as a major opportunity for us to grow the company. I spend a good deal of my time in this regard ' looking for strategic opportunities, both on the product acquisition phase and in terms of potential mergers or other acquisitions. TWST: What would you look for in a company that you would merge with or acquire? Dr. Gallagher: We have communicated to the market that we expect to turn profitable next quarter. We would like to post a profit for the full calendar year 2002. Therefore, we probably wouldn't want to acquire anything that would be dilutive to our earnings objectives. We're looking for products that are either already on the market or are very close to the market and that have largely overcome any development risks. We're looking for products that would be accretive from day one to our revenue and earnings growth. TWST: Can you tell us about the company's management style and general culture? Dr. Gallagher: Most of the senior management, including myself, have significant prior experience in large pharmaceutical companies. My background was at Bristol-Myers Squibb. Before that, I was at DuPont Pharmaceuticals, which of course was recently acquired by Bristol-Myers Squibb. Another key member of our group is David Pfeiffer, who's our Senior Vice President of Sales and Marketing. Prior to joining CollaGenex in 1997, he held various positions ' mostly in the marketing area, with both Smith-Kline-Beecham and AstraZeneca. Doug Gehrig is our Vice President of Sales. He had a longstanding career at Johnson & Johnson with McNeil Laboratories, as well as prior experience with Warner Lambert. Robert Ashley is our Senior Vice President of Commercial Development. He was a colleague of mine at Bristol-Myers Squibb. Before that, he was with Amersham Corporation in the UK, in a wide range of technical and business positions. Nancy Broadbent is our Chief Financial Officer. She was formerly CFO for a couple of high profile biotechnology companies, including Human Genome Sciences and Cangene Corporation. She also has 11 years of investment banking experience with Salomon Brothers and PaineWebber. Michael Romanowicz is our Vice President of Professional Affairs and Managed Care and is also a licensed dentist. Dr. Romanowicz was with Independence Blue Cross and managed their pharmacy programs prior to joining CollaGenex. Lastly, a recent addition to our team is Jeffrey Day, who's our Vice President of Dermatology. He comes with 14 years of experience from Ferndale Laboratories, which is a private dermatology company in Michigan, and the dermatology division of Allergen. Jeff heads up our strategic initiatives in the dermatology area. TWST: How many employees do you have overall? Dr. Gallagher: We have about 155 employees, of whom about 135 are in sales and marketing. We consider sales and marketing to be a key core competency for the company, although we certainly have ' as evidenced by our ability to get Periostat through the FDA ' internal development capabilities as well. TWST: Would you just tell us how you handle your sales force? Is there anything distinctive about your approach to sales? Dr. Gallagher: I think our sales force is highly experienced. We have recently converted our sales force from a paper-based reporting system to a handheld computer automated system. The sales force is very well managed by a group of experienced managers. Communication is rapid throughout the team. We have all the sophisticated electronic tracking sources in place so we know exactly the levels of business being carried out by each of our representatives and can manage their performance very closely. TWST: At some point do you expect to do a lot of business beyond the borders of the United States? Dr. Gallagher: We do have partners outside the United States in several areas ' primarily in Europe, the Middle East, Canada and Japan. Periostat is being marketed in the UK through our partner, Dexcel Dental. We are finishing the process of obtaining final marketing approvals for other European countries. We announced a few months ago that we now have approvals in more than half of the European countries. We're expecting further approvals throughout the rest of this year. TWST: Where would you reasonably expect the company to be, let's say, in about 2005? What would be some of the milestones that you might pass along the way that investors should keep their eye open for? Dr. Gallagher: I think first and foremost is what I mentioned earlier, and that is our turning profitable in 2002. We expect to continue the growth in our profitability, certainly over the 2002 to 2005 time frame. By 2005, we believe that our dermatology business will be significant and highly profitable, complementing our ongoing dental pharmaceutical business. We have had a longstanding collaboration with the National Cancer Institute ' the NCI ' to develop a drug called Metastat'. We are currently conducting Phase II studies in HIV-related Kaposi's sarcoma ' KS as it's called ' which is the most common malignancy associated with HIV. We've previously announced some very dramatic results and we appear to be observing the same types of results in the current Phase II trials. It is possible that by 2005 we could have Metastat on the market for treating this condition as well. Metastat is a once-a-day, pill- based therapy and, if successful, it would be the only effective pill- based therapy for treating this disease. The current drugs that are used, such as Taxol and Doxil, require two to four-hour intravenous infusions, and the patient has to take time off from work and go into the hospital or clinic every two to three weeks. TWST: How well are you understood by the Street at this point? Dr. Gallagher: I think we're probably not well understood by the Street. I think the fact that our first product is in the dental area immediately leads to confusion, with potential investors thinking that we're a dental company instead of a specialty pharmaceutical company. There are a number of dental supply companies, and these tend to be much lower-margin businesses. We are a specialty pharmaceutical company that earns pharmaceutical-type gross margins. I think we've worked hard to try to correct that impression that people may have and our institutional ownership has grown substantially. I think the market also needs to understand that, in the specialty pharmaceutical arena, we're rapidly entering the dermatology area with Periostat for acne and the potential applications for the Restoraderm technology. The total prescription market for dermatology products is between $5 billion and $6 billion; so even penetrating just a small piece of that for a company such as ours can have very dramatic impact on our growth prospects. We're also a technology-rich company with a pipeline. We have near-term, middle-term and longer-term drivers to our business. TWST: Can you give us the three or four best reasons why the long-term investor should take a good look at CollaGenex? Dr. Gallagher: First, management is committed to rapid revenue and earnings growth in the very near term to drive shareholder value. Last year, total revenues increased about 40% over the prior year. We've also been very aggressive in executing our strategy by acquiring new products through license and co-promotion agreements. We also possess a very rich product line, and the drug delivery technology to back it up ' both middle term and long term. We continue to make excellent progress in developing our pipeline ' most notably, in the cancer and dermatology areas. And we're executing on our strategy to grow the business. TWST: Is there a closing statement that you would like to make? Mr. Gallagher: The investment community needs to understand that we are different from many of the other specialty pharmaceutical companies. We are on the verge of profitability, and that's going to happen very quickly. At the same time, we have middle-term and longer-term pipelines that are going to be the key drivers over the next several years. TWST: Thank you. (MC) BRIAN M. GALLAGHER Chairman, President & CEO CollaGenex Pharmaceuticals, Inc. 41 University Drive Suite 200 Newtown, PA 18940 (215) 579-7388 (215) 579-8577 - FAX www.collagenex.com Each Executive who is the featured subject of a TWST Interview is offered the opportunity to include a Corporate Profile or other highlight material to be provided and sponsored by and for the company. Copyright 2002 The Wall Street Transcript Corporation All Rights Reserved 

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