James A. Schoeneck
Analyst · Roth Capital
Thanks, Augie, and thank you all for joining us on the call today. We appreciate your continued support and your interest in Depomed. I'd like to summarize the financial and operational accomplishments since our last earnings call, then I'll turn the call back over to Augie to discuss our finances, after which we'll open the call for questions. Gralise and our recent acquisitions, CAMBIA and Lazanda, led the way to a strong quarter. We doubled our net product sales over the same period last year, booking $28.2 million at the second quarter of 2014. Net product sales were up 31% over first quarter 2014, as we saw growth in prescriptions, demand units and shipments for each of our 4 products. Net sales for Gralise and Zipsor were up substantially from Q1 2014 and the comparable quarters of 2013, plus we gained traction with CAMBIA and Lazanda, the 2 drugs that we acquired in 2013. Lazanda sales doubled from the second quarter -- in the second quarter of 2014 from the first quarter, and CAMBIA net sales in 2Q were up 9% from Q1. For the first 6 months of the year, product sales were $49.8 million, an increase of 114%, compared to $23.2 million for the prior year. We're pleased with the revenue growth in Q2 2014, and we expect to deliver increasing sales for our 4 products during the remainder of the year. Let's look at each product, beginning with Gralise. As many of you know, Gralise's gabapentin formulated in our Acuform delivery system for the once-daily treatment of postherpetic neuralgia. Gralise net sales for the quarter were $15.1 million, an increase of 76% over second quarter 2013. Gralise total prescriptions were approximately 70,000 in 2Q, an increase of 7% over first quarter of 2014 and 22% over the comparable quarter of 2013. The size of our Gralise prescriptions are also increasing, driving tablet demand up 27% over last year. Our average Gralise prescription is now 85 tablets versus only 81 a year ago. And one more note on prescriptions. In July, we've had 3 of the 4 highest weeks for total prescription ever recorded for Gralise, showing that our second quarter momentum is carrying over into the third. I believe that one of the reasons for our continued growth at Gralise is the focused efforts of our sales force, working with pain specialists and neurologists to bring the benefits of Gralise to patients. Another is our work with managed care plans. From the beginning of our commercial efforts, we've seen managed care, including PBMs, as important partners. I'm happy to announce that Catamaran, the third largest PBM with approximately 25 million covered lives, has added Gralise to Tier 2 as of July 1, 2014. CVS Caremark and ESI already had Gralise on Tier 2, meaning that all 3 of the 3 largest PBMs now have our drug listed on that tier. Next, let's turn to CAMBIA. CAMBIA is the only single agent in its class approved for the treatment of acute migraine in adults. We acquired CAMBIA in late-December 2013, and we relaunched the drug in February. Net sales in Q2 were $5 million. We took an 11% price increase for CAMBIA, effective July 1 of this year, that reduced our second quarter net sales by approximately $300,000 as we increased our sales reserves for standard accounting policy. We expect to see increased sales of CAMBIA throughout the rest of the year as a result of this action. Second quarter was our first full quarter promoting CAMBIA, and it's now fully integrated into our commercial organization. Total prescriptions in 2Q increased 11% over Q1 and 18% over the same quarter last year. As we mentioned when we first acquired the product, we believe that CAMBIA is helping us deepen our relationships with the neurology community. July has also been a good month for CAMBIA, with prescription setting an all-time weekly high of 2,107 for the week ending July 11. CAMBIA is also positioned well with key managed care plans. As the only approved acute migraine therapy that doesn't contain a triptan, we believe that CAMBIA fulfills an important niche for both the physicians and the insurers. CAMBIA is Tier 3 with most plans, including the big 3 PBMs. Typical co-pays are $45 to $50 per prescription, a level that seems acceptable for many migraine patients. And one more point on CAMBIA, remember that the prior owner of CAMBIA only had 35 people selling the product, and Depomed has 164 reps carrying CAMBIA. CAMBIA is a brand-new product to many of our customers, and we anticipate prescription growth will benefit from this increased coverage in future periods. Lazanda is our intranasal fentanyl product for the treatment of breakthrough cancer pain that we acquired for $4 million and relaunched during the second half of last year. Lazanda net sales in Q2 were $1.4 million, up from $700,000 in Q1 2014. Lazanda has continued to perform well in July, setting new weekly prescription highs and averaging over 70 prescriptions per week, up from an average of 52 prescriptions per week in June. We continue to see over 90% of the prescriptions for Lazanda written by pain specialists, oncologists, and the physicians' assistants and nurse practitioners that work with them. Our highly focused sales force and our efforts to improve patient access with our Signature Support Program are bearing fruit, and we anticipate that sales will continue to accelerate during the rest of 2014. Plus we're all interested to see the effects that some of our competitive products have been placed on the 2015 Express Scripts exclusion list, and we'll see how it affects prescriptions both through the rest of the year and certainly into 2015. Zipsor continues to be a great contributor to our business as well. Second quarter Zipsor sales were $6.8 million, compared to $5.6 million in the second quarter of 2013, an increase of 21%. Sales increased 28% over Q1 2014. Since we acquired Zipsor for approximately $26 million 2 years ago, we've now booked $42.2 million in net sales with excellent gross margins. We expect Zipsor to continue to be a key asset for us over the next few years. During this call, I've mentioned managed care and PBMs more than a few times. The nature of our business is that payors are a key customer, and in fact, we include them in our corporate mission statement along with patients, their families and physicians. Depomed has not received any notice from major PBMs that any of our products will be added to exclusion list in 2015. To be clear, we will continue to work with managed care to provide access for our products so that patients and physicians can choose to use them. As we've discussed in prior calls, revenues from partnering and licensing continue to be an important part of our business. The partnerships we have in place continue to create value for us, and the most significant contribution last quarter again came from our agreement with Mallinckrodt. Mallinckrodt's XARTEMIS XR, an extended release formulation of oxycodone and acetaminophen, utilizing our Acuform technology, was approved by the FDA and launched at the very end of Q1. We recognized a $10 million milestone in Q1, and we received a cash payment in Q2. We'll receive high single-digit royalties on the net sales of XARTEMIS XR through 2032 based on recently issued Mallinckrodt patents. In addition, MNK-155 is Mallinckrodt's second product that uses our Acuform technology. MNK-155 is an extended-release formulation of acetaminophen and hydrocodone. Mallinckrodt filed MNK-155 with the FDA at the end of first quarter, and the NDA was accepted by the FDA in May. This triggered a $5 million milestone, which we recognized as revenue in Q2. We received the cash payment in June. If the drug is approved, we'll receive a $10 million milestone, and we will receive the same high digit single -- high single-digital royalties on net sales as we received on XARTEMIS XR. The company is in a very strong financial position. We ended the quarter with $223.7 million in cash, an increase of $10.7 million during the quarter. Our strong balance sheet, with no debt, enables us to support the growth of our existing product portfolio, as well as aggressively seek additional product opportunities through acquisition. Our focus remains on pain and neurology. And while we can't predict the timing of any future acquisitions, our business development team remains active in evaluating and pursuing high-growth opportunities. Let me shift from a discussion our financial accomplishments to a quick summary of other operational achievements. In Q2, we conducted the ANDA trial relating to Gralise. As disclosed in our press release of July 17, the judge in the case imposed a preliminary injunction against Actavis, effectively extending the 30-month stay until the judge renders his opinion in the case. We expect the opinion in short order to use the judge's words. With the 8 patents we asserted Actavis, we remain confident of a favorable outcome in the trial. I also want to mention 2 significant recent additions to our management team. In July, Dr. Srini Rao joined us as our Chief Medical Officer. Srini has deep experience in pain and neurology, along with the experience across the full scope of our business, from development to licensing. Then earlier this week, we announced that Scott Shively will join us as our Chief Commercial Officer. Scott has extensive commercial leadership experience in sales and marketing of pain and neurology products for both specialty and larger pharmaceutical companies, including Pfizer, Endo and Al Pharma[ph]. We're extremely pleased to welcome both Srini and Scott to our management team. To sum up, we're excited about the prospects for our business for the remainder of the year. Depomed today is a product-focused, growth-oriented specialty pharmaceutical company, with a growing franchise of treatments for pain and neurology. With increasing revenues from our 4 marketed products, over $223 million in cash and no debt and a strong management team, we look forward to growing the company in the remainder of 2014 and beyond. I'll now turn the call over to Augie to discuss our financial performance. And then we'll be happy to take any questions when we conclude the presentation.