Jim Schoeneck
Analyst · RBC Capital. Please go ahead
Thank you, Chris and thank you all for joining us today. Before I begin my remarks on our second quarter, I’d like to briefly discuss the latest developments with respect to Horizon Pharma. As most of you’re aware, on July 7, 2015, Depomed announced that the Board of Directors had unanimously rejected an unsolicited proposal from Horizon to acquire Depomed in an all-stock transaction valued at $29.25 per share. Following its review, the Board concluded that the Horizon proposal was opportunistic and highly conditional and importantly, did not reflect the inherent value of Depomed in light of the Company’s standalone prospects. Additionally, the Board noted that Horizon’s proposal was identical to the proposals received by Depomed on May 27 and again reiterated by Horizon on June 12. On July 21, Depomed confirmed receipt of a purported revised proposal from Horizon to acquire Depomed in an all-stock transaction valued at $33 per share. Earlier today and as many of you’ve already seen, Depomed’s Board announced that after careful consideration and with the assistance of independent financial and legal advisors, that it has unanimously rejected Horizon’s purported revised offer. The Board and its decision underscored that the purported revised and highly conditional nature of Horizon’s latest proposal, noting that it does not reflect any increase in the amount of Horizon’s stock that our shareholders would receive nor any increase in the pro forma ownership for Depomed shareholders. It simply just restates a purported increase in Horizon’s July 21 proposal. And that increase was a result of the trading price of Horizon stock having increased since their initial proposal. And in line with its prior rationale, the Board reiterated that Horizon’s proposal substantially undervalues Depomed’s business and does not reflect the inherent value of Depomed in light of its standalone prospects. As demonstrated by Depomed’s record sales and cash flow during the second quarter, which we will provide details on shortly, Depomed continues to drive tremendous value for our shareholders and significant growth opportunities that extend well into the next decade. We believe the timing of Horizon’s proposal is opportunistic and takes advantage of a temporary decrease in Depomed stock price. In addition, Horizon’s proposal fails to appropriately compensate Depomed shareholders for the significant synergies that Horizon claims would be created by a business combination between Horizon and Depomed. Ultimately, the Board strongly believes that an independent Depomed will create significant and sustainable value for its shareholders both in the short and long-term through focused execution of our business plan and strategic vision. We are confident in our strategy, our future growth prospects and with today’s strong results that we’re clearly on the right track and well on our way to becoming one of the top five pain companies in the United States by 2016. While I understand the interest in the Horizon situation, I’ll now turn to the purpose of today’s call, which is to review Depomed’s record second quarter earnings and outlook. We ask that you focus your questions on our second quarter as we do not intend to comment on the Horizon matter beyond what the Board announced today. With that, let’s turn to our earnings. We’re pleased to report another record quarter of sales. On this call, we will cover a number of reasons why we’re increasingly confident in both the immediate and long-term growth prospects for Depomed that position us to continue to deliver substantial shareholder value. Our story continues to be one of tremendous growth. Thanks in part to the dedication of our employees and the support of our shareholders, Depomed stands today as a force in the pain and neurology marketplace with significant and numerous growth inflection points ahead. The second quarter of 2015 produced record setting sales for our Company as we achieved net product sales of $94.3 million. This represents a growth of 234% compared to the second quarter of 2014. To put this in an even broader perspective, at the midpoint of our revised 2015 guidance, the compound annual growth rate for our product sales since 2012 would be 129%.Our bottom line growth was equally impressive. I’m happy to report that we achieved non-GAAP adjusted EBITDA of approximately $37 million for the quarter and non-GAAP adjusted earnings of $0.27 per share. Finally, we had $55 million of cash in the second quarter, which puts us on track to prepay $100 million of debt in the second quarter of 2016, delevering our balance sheet and reducing our future interest charges. These impressive financial results coupled with numerous growth opportunities, which we will talk about later in this call, make us even more confident in Depomed’s bright future. In line with this strong performance, today we’re revising our guidance for 2015 including raising 2015 product sales guidance to a range of $320 million to $340 million, non-GAAP EBITDA to $95 million to $110 million, and non-GAAP adjusted earnings to $40 million to $50 million, up from our prior guidance of $16 million to $28 million. Augie will provide a comprehensive look at our revised guidance in his remarks. The second quarter marked the debut of NUCYNTA as the flagship product in our portfolio. I’m pleased to say that NUCYNTA is off to a great start, posting second quarter sales of $56.7 million. Several factors contributed to NUCYNTA sales for the quarter. First, we were able to close the NUCYNTA transaction ahead of schedule on April 2, enabling us to realize a full quarter of sales as we began shipping product on April 6. Next, we implemented a pricing adjustment of 44%, which brought the monthly price of NUCYNTA ER in line with market leading Oxycontin. As previously noted and reflected in our results, we captured about half of that adjustment immediately and expect to capture most of the rest of the adjustment over the rest of 2015 and 2016. Continuity was a key to our second quarter success as well as we hired Quintiles, the same contract sales organization that had marketed NUCYNTA previously to continue selling on our behalf while we completed the recruitment for positions in our expanded sales force leading up to our relaunch of NUCYNTA in June. As impressive as NUCYNTA’s second quarter numbers are, we believe we’ve just scratched the surface with this innovative product and that we’ve the potential to reach peak sales higher than we initially anticipated. Our new NUCYNTA positioning and expanded commercial relaunch efforts are now well underway. In addition to NUCYNTA, we saw strong sales performance across our portfolio of highly differentiated pain and neurology products. Product sales for the second quarter excluding NUCYNTA increased 33% to the same period in 2014 led by Gralise, Cambia and Lazanda. All three products showed significant year-over-year prescription growth with Gralise up 18% and Cambia up 35%. Lazanda was up even more dramatically with demand unit growth up 156% over the same quarter last year. Further, Gralise, Cambia and Lazanda have each grown market share since last year and in fact, Lazanda’s market share has doubled since Q2 of last year. Augie will provide specific product sales results for the second quarter and you may also find this information in today’s press release and on Depomed’s quarterly report on Form 10-Q that will be filed later this week. In addition to pointing to a superb second quarter, these product sales and prescription results speak broadly to an important component of our continuing growth story. We have demonstrated repeatedly that we can acquire, integrate, and grow products marked by sales growth, prescription growth, and market share growth. We expect that trend to continue and with it a period of accelerated growth for our Company extending well into the future. I’d now like to spend a few minutes on each of these growth opportunities. First and foremost, we believe NUCYNTA has blockbuster potential and can achieve greater peak sales than we originally anticipated. There are four key elements to our NUCYNTA plan: one, significantly increased promotion, two, totally revamped product positioning and messaging, three, pricing and access strategies to maximize the brand and this is new, four, proper dosing. Each has an impact on our sales ramp and the ultimate peak sales potential for NUCYNTA. Now let me give you some more info on each one. First, promotion. The key component of our strategy is the strength of our sales and marketing force. We officially relaunched NUCYNTA in June with a significantly expanded sales force of 275 highly experienced and specialized pain and neurology reps. This sales force is over three times larger than the prior sales force and allows us to rapidly and effectively engage to more than 25,000 target prescribers as we raise the profile of NUCYNTA. Our sales force is fully deployed and energized targeting 8 to 10 prescriber calls per day. And here is one new observations since our relaunch. There seems to be a group of physicians that have either prescribed NUCYNTA in the past or prescribe more NUCYNTA than they have recently. This latent demand may turn out to be an additional driver of NUCYNTA as Depomed reengages these physicians. Our medical and marketing activities have ramped up as well. During the month of July, over 300 medical support and speaker programs are being executed, including a national webcast that is expected to draw healthcare professionals from nearly every state. It’s important to note that while we began distributing NUCYNTA at the beginning of April, our relaunch took place in mid June, so the benefits from our commercial relaunch strategy should become evident later this year. The second leg of our plan is to revamp product positioning. Our commercial strategy centers on new product messaging focused on NUCYNTA’s dual mechanism of action designed to target both nociceptive and neuropathic pain. As the only FDA product that approved -- that addresses both types of pain, we’ve received feedback that this differentiation is working with the physicians and we believe these attributes will help us capture additional market share. The marketplace is significant, with over 100 million U.S patients with chronic pain and 31 million with chronic lower back pain. With NUCYNTA, we’re specifically targeting the chronic lower back pain population as many patients report symptoms of both types of pain. This patient group hasn’t been effectively targeted in the past, but we’re hearing from our reps that targeting chronic lower back pain is resonating with the physicians. In fact, in just the first three weeks of launch, we’re seeing about 700 new or renewed prescribers of NUCYNTA or NUCYNTA ER each week. We see this as an important driver for NUCYNTA growth. In addition to low back pain, NUCYNTA is just now being launched for moderate to severe painful diabetic neuropathy or DPN, an FDA approved indication that is unique among the opioids. We expect the moderate to severe DPN market, which may impact another 1 million to 2 million patients to be another driver of NUCYNTA growth. Our third NUCYNTA growth driver is pricing and access. I’ve already mentioned that the initial realization of our earlier pricing adjustments happened in second quarter. We also anticipate that managed care dynamics will continue to provide broad patient access for NUCYNTA. One example is the recent change to the United Healthcare Commercial formulary. Effective July 1, UHC removed OxyContin from Tier 2 coverage and now requires a triple step edit. This means that to use OxyContin, a patient must fail three or four formulary alternatives before receiving coverage. NUCYNTA ER is one of the two branded drugs that remain on formulary in front of OxyContin. This is an important advantage as the UHC commercial lives are almost 14 million and we expect this change to impact prescriptions later this year. The fourth opportunity for sales growth is proper dosing of NUCYNTA. This is another new observation we’ve had since we’ve taken over the brand. Here are the basic numbers. The average dose of NUCYNTA ER used by patients in the clinical trials for low back pain was approximately 400 milligrams per day. Yet when we look at the average doses in the marketplace, there are currently between 200 milligrams and 250 milligrams. We believe that education focused on proper titration can improve both the physician and patient experience with the product and we also feel it has the potential to increase sales by 50% or more as patients move toward doses most often seen in the clinical trials. I had one more point on NUCYNTA. We believe the market exclusivity can carry us beyond 2023. In fact, composition of matter patents cover tapentadol to February 2023, including the pediatric extension and cover the marketed polymorph form of the drug until December 2025, also including the pediatric extension, plus the DPN pain use patent goes to 2028. As you can see, there is tremendous opportunity for growing the NUCYNTA franchise over many years and we believe it has the potential to become a blockbuster. We believe that with our strategy in place and our experienced team behind it, NUCYNTA has the potential to achieve greater annual sales being $500 million by 2020 and to eventually surpass $1 billion before the patent expiration. We see continuing growth coming from the rest of our product portfolio as well. Pricing adjustments made in June to Gralise, Cambia, Lazanda and Zipsor to stay on par with market leaders. We anticipate that these pricing adjustments where we start to see additional sales in third quarter. We also intend to grow product revenue through label expansion and product line expansions and we look forward to updating you on these opportunities in the future. A key strength of Depomed is the lengthy exclusivity periods for our products. Our track record in this area continued in second quarter with separate litigation settlements for the appeal of our Gralise litigation win confirming market exclusivity for Gralise till 2024 and with the first Zipsor ANDA filer with expected generic entry in March 2022. In early July, a decision by the Patent Trial and Appeal Board and the Inter Partes Review followed by Purdue Pharma, confirmed the patentability of each of the patents subject to the IVRs paving the way to continue our patent infringement case against Purdue related to reformulated OxyContin. This brings me to the final critical driver of future growth for Depomed, our acquisition strategy. While we focus on successfully integrating and growing our products, we’re constantly evaluating new acquisitions in pain and neurology that provide growth opportunities for the Company. Our business development efforts remain aggressive. Through the first half of 2015, we’ve evaluated more than 60 acquisition candidates with the goal of identifying and closing deals that create significant value. This acquisition strategy will continue to be a major component for our Company’s growth. Our criteria remain constant. We look for pain and neurology products with lengthy exclusivity and peak sales upside. And we continue to consider tax conversion opportunities that would also bring strategic value to our business. The transformation of Depomed which begin in 2012, and has included a series of strategic and timely transactions is complete. We believe that we’re now in the early stages of an accelerated period of growth, a trend that we anticipate will last well into the future and it will be marked by significant gains in product sales, prescriptions, and market share and increased value for our shareholders. And with that, I’ll turn it over to Augie to discuss our finances and guidance.