In Part II of our discussion with DARA Biosciences (NASDAQ: DARA) CEO and Chief Medical Officer Dr. David Drutz, we look into key catalysts for the specialty pharmaceutical company. Dr. Drutz discusses the medical need for the oral-liquid tamoxifen, Soltamox, licensed to DARA by UK-based Rosemont Pharmaceuticals — as well as the market opportunity in developing oncology services.
Dr. Drutz also addresses financial milestones and strategies in building shareholder value. In recent weeks, the North Carolina-based company announced it had regained Nasdaq price compliance and remains on schedule for distribution of its lead product Soltamox in Q4-2012.
View Part I for a discussion of the company’s in-licensed portfolio, which includes Soltamox, Gelclair and Bionect.
Listen to the interview, and view the transcript below.
Matthew Margolis: This is Matthew Margolis with OneMedRadio back for part 2 of our discussion with Dr. David Drutz, CEO of and Chief Medical Officer of DARA BioSciences. The company is a publicly traded market stage specialty pharma trading under the symbol DARA on the NASDAQ. In part 1, we discussed recent developmental milestones and the company pipeline, which includes exclusive licenses to market Soltamox, GelClair, and Bionect in the US. We’re talking today about some recent financial highlights and what we can expect in the future.
So David, when we last spoke, we learned about the company’s reasons for moving to acquire out-licensed products due primarily to what you said are changing tides in the industry in which investors are valuing revenue opportunities over difficulty to achieve long-term milestones and partnership opportunities. In January 2012, DARA acquired Oncogenerix, a company with access to DARA’s new lead product and led by Chris Clement, DARA’s current COO. I want to ask how DARA BioSciences was actually able to position itself as the ideal partner for these new products. What was the key here?
David Drutz: The reason that Oncogenerix had access to Soltamox is because Chris Clement had a years long strong personal relationship with the company from which he licensed the drug Rosemont Pharmaceutical in the UK. So access to Soltamox came by virtue of longstanding personal relationship. Similarly, we acquired the rights to sell a topical agent for treating radiation skin damage from a company called Innocutis in South Carolina with which Chris had a strong longstanding personal relationship. Our recent acquisition of GelClair from Helsinn in Lugano, Switzerland was based on a very strong personal relationship that Chris and I developed with the senior leadership of that private Swiss company in recent months. So a lot of this just has to do with years in the industry and shared experiences and long relationships.
MM: So let’s talk about the market opportunity for Soltamox and what is the expected rollout in the US?
DD: First of all, Soltamox is the liquid form of a drug, a venerable drug that’s used for the treatment of breast cancer but is available only in pill form. That drug is called tamoxifen and Nolvadex was its original brand name, it’s now a generic. It’s always been available only in pill form in this country. The liquid formulation which is FDA approved, we acquired from a company called Rosemont Pharmaceuticals in the UK, actually in Leeds in the UK and Rosemont is a totally UK focused company. It sells and markets only in that company.
The answer to your question is since the Soltamox, the liquid form of tamoxifen was only sold in the UK, the only data I can give you or data that Rosemont itself has given us. **Editor’s note: In Part I of the interview Chris Clement indicated Rosemont Pharmaceuticals estimates Soltamox to account for 2-3% of tamoxifen sales in the UK.** They don’t regard themselves as a specialist in oncology, oncology support or anything else. They’re a specialist in liquid medications. So it is our assumption but it’s only an assumption that by being quite specifically focused in the oncology, oncology support space, we might be able to do better.
MM: Now let’s shift gears and talk about your shareholder value. Upon receiving a notice of regained NASDAQ compliance, you’ve decided not to go forward with the reverse stock split. How much shareholders in recent months received the progression and success of your business plan?
DD: After we did the acquisition of Oncogenrix, we needed to raise money and we did raise money. We raised $10.25M somewhere in the April timeframe and we were very busy bringing these products in with future sales in mind and therefore very, very mindful of our cash and also very, very mindful of our NASDAQ listing. We consider the NASDAQ listing to be absolutely precious and essential to us and we were very concerned when our stock price because of the nature of the financing our stock price dwindled to approximately a dollar and then slipped below a dollar and then slipped below a dollar long enough for us to get a notification from NASDAQ.
We knew or we felt strongly that the only way we could get our stock price back up was to deliver on our business plan and we worked very hard to do that but there’s only so much one can accomplish within any given period of time. As a backstop to the possibility that even our best efforts in fulfilling our business plans wouldn’t be enough for the marketplace, we felt that we had to have a reverse stock split opportunity at least lined up. We didn’t like it, we knew our investors wouldn’t like it but we considered the NASDAQ listing as I said to be precious.
The answer to your question is we did immediately pull actually the scheduled proxy vote on the reverse split once we had regained compliance with NASDAQ. That compliance by the way was driven by press releases indicating that we were fulfilling on our business plan. The word around was the shareholders were relieved that we were not planning to do a reverse split because no one much likes that. I would say it was regarded positively.
MM: What can you highlight from your recent earnings? What is your cash position right now?
DD: Well the last time we talked about cash were based on our last Q and also an 8K that we had submitted on September 27. So as of that time, we had $8.3M in cash and no debt.
MM: And what do you estimate your burn rate to be?
DD: We have been steadily decreasing our burn rate and we don’t anticipate having to raise cash again until somewhere in mid-2013. But that may not even be necessary because of revenues that come in from the products that we’re moving to the market.
MM: What is the significance of your September announcement of a vertically integrated commercial platform for the marketization of the company’s portfolio?
DD: When Chris brought in his team, one of the people he brought in and I said everybody was highly experienced, was a highly experienced our vice president of business development, sales and marketing, David Benharris. David had put together sales teams before that sold into niche markets and especially oncology markets, highly specialized markets and has a thorough understanding of reimbursement and all of the issues that go with trying to sell drugs today especially generic type drugs.
So he fairly quickly, I should say we fairly quickly after the merger acquisition had been accomplished brought in a very surprisingly experienced team of senior sales representatives but they’re more than reps. They really are – they’re really business leader types sales and marketing people and they’re deployed across the United States, there are five of them. But that’s only five people and we’re pretty ambitious about the way we want to be able to penetrate the relevant markets. So you can’t do it by yourself and the purpose of the press release where we talked about, leveraging our five sales and marketing people with the help of specialty pharmacies and all the rest that was in that press release was to indicate how we leveraged our core capabilities against a much broader group of individuals who in fact act as a multiplier for our sales and marketing efforts. So our grasp may actually be better than our reach.
MM: That’s part 2 of the snapshot of key catalysts for DARA BioSciences trading on the NASDAQ under the symbol DARA. For Dr. David Drutz, this is Matthew Margolis with OneMedRadio signing off.