John L. Higgins
Analyst · Roth Capital Partners
Erika, thank you. And welcome to our Q3 earnings call. We just closed an extraordinary quarter, both financially and operationally. We're pleased to be speaking with you as we enter the final months of 2013. Our revenues continue to grow sharply, with this quarter's total revenues more than doubling last year's in the same period. Our royalty revenue from our 5 royalty-bearing assets increased significantly, with the most growth contribution coming from Promacta and Kyprolis. Our Captisol business continues to perform very well also. In the third quarter, we received significantly higher Captisol orders than expected, in part from a few new customers and in part due to orders from existing customers as their late-stage trials get underway or their product commercialization efforts ramp up. Now even with the robust revenue growth, expenses were essentially flat with last year as we projected. Again, strong revenue growth and generally flat expenses. The financial results this quarter are an illustration of the power of the Ligand financial model. This quarter shows how we can realize major revenue growth even without increasing expenses. Couple that with 3 quarters of $1 billion of tax assets and a lean share count, and this is not hard to envision the company's incredible financial leverage, which, over time, should generate significant cash flows. Now beyond the recent financial results, we are even more excited about Ligand's pipeline. Our portfolio has never been larger or as advanced in stage or quality as it is now. Over the past few months, we entered into new deals, saw trial initiations and newly published data for late-stage programs, a couple of programs advanced towards NDA submissions and most significantly, a couple of products received approvals for new indications. Now a simple way to point out the impressive quality of our pipeline is with the fact that numerous CEOs of the world's largest drug companies, like Pfizer, Merck, Amgen and GSK, talk about Ligand programs in their Q3 press releases and earnings call in just this past week alone. For example, at the very beginning of Pfizer's earnings call yesterday, CEO Ian Read talked about Duavive, a drug that stems from a mid-1990s research deal with Ligand and was approved in the U.S. this month. Now many investors at Ligand wrote Duavive off as a drug that would never get approved given the difficult regulatory environment at the FDA over the past several years for this category of medicine. While that was not an unreasonable view, all along, we were bullish on the approval prospects, given the very well-run trials and the strong data profile of the drug and the very important medical need. Now Duavive is a combination serum and conjugated estrogen product indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis. We encourage investors to do work on this category to consider the potential of the drug. We view this segment of the women's health market to be very significant. And despite many medicines currently on the market, there is still considerable unmet need. We are eager to see Pfizer's launch in the U.S. and the regulatory developments in Europe next year. For now, the good news is we expect to start to earn royalties from this product in just a few months, adding to the other 5 products generating royalties for Ligand. Now Promacta continues to perform very well. Q3 sales came in at $76 million, up a robust 9% over the prior quarter and up 43% over the period a year ago. What is significant is that now, based on year-to-date sales, we're earning royalties at the third highest gross royalty tier of 8%. That is a meaningful step in rate as royalties start at a 5% tier on sales at the start of the year. Now just 2 months ago, Promacta received EU approval for the use in severe hepatitis C. In Europe, the drug is branded Revolade. Now this is an important medical category even with the new ACV drugs coming online, given the potential to support the medical care for the most severe patients. Just a few months ago, the drug was approved in only 4 countries for the ACV indication. Now it's approved in 37 countries, and the list grows every month. Now further for Promacta, the impressive body of oncology data continues to grow meaningfully, notably with data presented at IHA this past summer in NBS and AML. And as in past years, we would expect more data to come out for the potential new indications at upcoming medical meetings. As GSK makes progress with its oncology-related trial, it puts the drug on course for potential filings for further expanded uses. Now in regards to Kyprolis, Amgen completed its $10 billion acquisition of Onyx Pharmaceuticals on October 1. The multiple myeloma market is a large medical category that is predicted to grow substantially over the next 5 years. We see Kyprolis as a drug with significant expansion opportunities, both geographically and potentially into earlier lines of therapy. Beyond these highlights for some of our key programs, I would like to comment briefly on our R&D initiatives, which are taking hold with recent developments. As an overview, what may be underappreciated at Ligand is our rich drug discovery in early development heritage. While investors are familiar with Promacta, and now Duavive, for example, as commercial stage assets, the significance of these products is they came from our internal R&D efforts. Our top scientists are still at Ligand. And that R&D entrepreneurialism is very much alive now. We are investing in some exciting early-stage programs such as diabetes and cancer supportive care, with new data coming out over the next few quarters. The investment, research, productivity and data are creating additional opportunity and value at Ligand as we pursue new licenses. Before I turn the call over to Matt, I will add that we remain true to our business model and vision for how to build a high-growth company in the biotech industry. Our business is focused on amassing a large portfolio of fully funded pharmaceutical assets while minimizing the traditional risks that small-cap biotech companies face. The premise of our model is identifying good research targets and technology, good dealmaking through acquisitions and licensing, operating with a lean cost structure and broad portfolio diversity, all with the goal to maximize sustainable cash flow. Now, more than any time before, there is tangible evidence our business model is turning into a success. And as I said on our last call, in many ways, we believe the potential of the Ligand model is just beginning to be realized. Matt?