Depomed, Inc. (DEPO-NASDAQ)

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July 2, 2010 Issue

The Most Powerful Name In Corporate News and Information


With Deals In Place With Merck, Covidien And Abbott Labs, Depomed, Inc. Is Well Positioned To Generate The Cash Needed To Transition The Company From A Drug Development Company Into A Specialty Pharma Company

Company Profile:

Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical developm=nt and has been licensed to Abbott Products, Inc. Product candidate SeradaTM i= in Phase 3 clinical development for menopausal hot flashes. GLUMETZA(R) (metfo=min hydrochloride extended release tablets) is approved for use in adults with =ype 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to th= upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy.

Carl Pelzel
President and CEO

Mr. Pelzel joined Depomed in June 2005 as vice president of Marketing and Commercial Development. In September 2005, he was appointed executive vice president and chief operating officer, a position he held until being appointed president and chief executive officer in August 2007. Before joining Depomed, Mr. Pelzel was senior vice president, Global Commercial Operations at Chiron Corporation. Under his leadership, Chiron Biopharmaceuticals generated sales on a global basis through operations in North America and Europe as well as through a network of international distributors. Prior to joining Chiron, Mr. Pelzel served as president and chief executive officer of Invenux Inc., a privately-held biopharmaceutical company. Mr. Pelzel also spent 11 years with GlaxoSmithKline in senior-level sales, marketing and international operational positions, including country manager of Hong Kong and China. He spent 13 years with American Home Products, focused primarily on the company’s antibiotics business. During his career, he directed the launch of five major pharmaceutical products, many on a global basis. Mr. Pelzel received a B.A. degree from Hartwick College of Oneonta, New York, and a Masters degree in Natural Sciences from the University of Paris.

Drug Manufacturers - Other

Depomed, Inc.
1360 O’Brien Drive
Menlo Park, CA 94025
Phone: 650-462-5900


Interview conducted by: Walter Banks, Publisher,, Published – July 2, 2010

Mr. Pelzel, how long have you been with Depomed, what brought you to the company and what is the vision going forward?
Mr. Pelzel: I’ve been with Depomed for five years and what brought me to the company is the opportunity that I saw to use the company to take advantage of some massive changes that were happening in healthcare. The company has a unique technology that can change the performance of existing drugs in ways that I knew would be important to managed care. Some of the changes that we are seeing in managed care are eliminating the path of “me too” products that traditionally had formed the backbone for the success of big pharma. So I saw Depomed as a vehicle that could be used to take advantage of this change in the marketplace, by taking existing drugs and giving them beneficial, patient oriented differences that managed care would have to pay for, compared to simply changing an existing compound in a small way and relaunching with a different brand name as big pharma had been doing for years. The vision for the company is to take Depomed through a transition to become a specialty pharma company. The company was developed as a drug delivery company on the back of some very innovative patents from which the company was founded. Those patents give us the ability to create a tablet in a solid dosage form that sits in the stomach for 9 hours and from that launching point, can deliver drugs in a variety of ways that can impart clinical and side effect differences to existing drugs. What makes Depomed exciting is that this is the only company that has demonstrated what scientists called a gastric retention capability. So it is the ability to keep a dosage form in the stomach for a prolonged period of time and thereby change how some drugs perform. This transition that I was talking about is indeed to move the company from a drug delivery company, to a specialty pharma company. That will take two forms. Number one, we are going to use our existing technology to solve formulation problems for other companies and that will generate cash for us. We will then use that cash to proceed with our development as a specialty pharma company. Now how we do that, and again part of the vision, is that we will take some of the products that come out of our development programs, and we will at the right time, start a sales force and commercial organization that will allow us to launch these products and thereby keep the majority of the economics that these products have the potential to generate.

CEOCFO: Where are you now?
Mr. Pelzel: We have taken our technology and we have broadly communicated that we are no longer a drug delivery company. We will no longer do the traditional fee for service, in other words we won’t do formulation work in the hope that we might eventually get to a licensing deal. We will only practice our technology if there is a licensing deal at the beginning. This has been demonstrated recently in the deal with Merck last year and a deal with Covidien. We have developed a product based on gabapentin, originally developed by Warner Lambert, which is now Pfizer. We have taken that compound, which was very successful as it did $2.7 billion worldwide in 2004 before it went generic, and we have made it better. We have made it better in a way that is meaningful to managed care. The two drawbacks to this product have always been the fact that it causes a high incidence of dizziness, roughly 30%, and a very high incidence of daytime sleepiness, roughly 35% to 30%. Both of these limit the extent to which patients can tolerate the drug. We have taken this drug, put it into our technology and all but eliminated the daytime sleepiness. It is the same as placebo, and reduced the dizziness by two-thirds. What makes this interesting is the following. When Pfizer saw that they were going to lose their patent on gabapentin, they looked, as big pharma traditionally does, for another product to take its place so that they wouldn’t completely lose the sales franchise that they had worked so hard to develop. They developed a product from the same drug class as Gabapentin which they call Lyrica and they proceeded to launch that product. I predict that had they launched Lyrica ten or fifteen years earlier, it would have been wildly successful. This is because at that time managed care did not have the power that they have today. Unfortunately for Pfizer, when they launched Lyrica, managed care and physicians recognized that there were very few, if any differences between their old drug gabapentin and their new drug Lyrica. Both of those products cause the same amount of dizziness and daytime sleepiness, and both work to the same extent in reducing pain. As a result, managed care rather uniformly, refused to allow reimbursement for the new drug Lyrica until patients failed on the original drug which is now generic – Gabapentin. As a result, Lyrica has only achieved modest success. I say modest success, even though Lyrica generated about $1.5 billion in the United States last year, but the marketplace is a $5 to $6 billion marketplace, so they could have generated much larger sales had Lyrica had some meaningful advantages to offer patients that managed care would have been willing to pay for. This is interesting because managed care was able to halt the success of Lyrica, because there were no differences between the two compounds. As a result, doctors could not convince managed care to pay for the new drug. However, our product was specifically designed to bring forward patient benefits that would be meaningful to doctors, patients and managed care, so that physicians will be able to convince managed care to pay for our product, which is dosed once a day, has virtually no daytime sleepiness and has 1/3 the dizziness of the original compound.

CEOCFO: Where does that take you?
Mr. Pelzel: We have taken that compound, developed it for nerve pain and we have licensed it to Abbott. Our filed NDA (New Drug Application) has been accepted and we anticipate a rapid FDA review. Once approved, that will generate a very significant 14% to 20% revenue stream for Depomed. That cash will be used to complete our transition from a drug delivery company to a specialty pharma. In addition to the royalties, we will get up to $60 million in milestones at approval and again that cash is important to us. We then took that same gabapentin program and we developed it for hot flashes, which is a very debilitating side effect of menopause. The only drug that is currently approved in the U.S. for menopausal hot flashes is estrogen. As we all know, estrogen has been under intense scrutiny because of the proposed link between the use of estrogen and breast cancer, cardiovascular events, and stroke. Therefore, our gabapentin product has the potential to be the first and only non-hormonal therapy for hot flashes. This program is not currently partnered as it represents the springboard for us becoming a specialty pharma company. We are about to start our last Phase III trial that will bring us to registration and approval for the hot flash product. So to complete the vision, we will use the funds that will come from our Abbott collaboration to create a specialty pharma company in women’s health. That women’s health company will initially promote our hot flash product and will also promote other products that we have been able to gain access to for women’s health.

I would like to digress and talk about how we have used our technology to generate cash to enable us not to have to raise any money since the 2nd Quarter of 2007, and yet in the last quarter to have $71 million in the bank. We have consistently been successful at using our technology, because of its uniqueness, to generate cash through business development deals that require very little work on our part. As I mentioned, we have a deal with Merck, we have a deal with Covidien on up to four products and these deals and these fields continue to be explored, keep us away from the capital markets and keep us well funded.

CEOCFO: Why then should investors be interested in Depomed?
Mr. Pelzel: There are three reasons why investors should be interested in Depomed. First, we are positioning ourselves for the changes that are happening in healthcare, as opposed to having those changes thrust upon us. We think that by using our technology in a way that will be attractive to managed care that we are positioning ourselves for success in this new environment, as opposed to trying to run away from it. Number two, we are well capitalized and we have a continuing source of capital in our unique technology. Number three, we have a clear vision and path to being a profitable company with our hot flash program and women’s health business. What is important there is that most specialty pharma companies become specialty pharma companies by buying someone else’s existing product and trying to find a way to generate more sales than the original owner of the product was able to. Now in some cases that is successful. But it is a rather risky roll of the dice and incredibly expensive, because you are buying an existing asset with an existing revenue stream. We on the other hand have used our technology to develop our own compounds in a relatively inexpensively manner, because we are not buying them. We focus on developing products in large rapidly expanding markets, that being the nerve pain market and represented by our collaboration with Abbott, and our hot flash product, which is unique in that it is the only product other than estrogen to treat menopausal hot flashes. So that is the investment premise for the company in a nutshell.

CEOCFO: In closing, how did Depomed come to be in position of your current products; was it through licensing, acquisition or partnering?
Mr. Pelzel: With our gabapentin program for example, gabapentin is available generically, so we had access to it and we identified the side effects associated with gabapentin as particular side effects upon which our technology could confer advantages. Our technology can not make every product better of course, but there are certain products where our technology can be brought to bear to the benefit of patients from a side effect or a clinical efficacy perspective.


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The vision for the company is to take Depomed through a transition to become a specialty pharma company. The company was developed as a drug delivery company on the back of some very innovative patents from which the company was founded. Those patents give us the ability to create a tablet in a solid dosage form that sits in the stomach for 9 hours and from that launching point, can deliver drugs in a variety of ways that can impart clinical and side effect differences to existing drugs. - Carl Pelzel

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