August Moretti
Analyst · RBC Capital Markets
Thank you, Jim. Today I’ll cover two areas; first, a review of the highlights of our third quarter results; and second, our updated guidance for 2015. Before we get started, I want to mention that I will be discussing certain GAAP measurements, as well as certain non-GAAP measurements. Please refer to today’s press release for an explanation of our non-GAAP financial measures and a table that reconciles Depomed’s non-GAAP adjusted earnings per share. In addition, our guidance today will also include certain non-GAAP financial measures, which we expect to continue to present in future periods. As Jim outlined for you earlier in the call, the third quarter was an exceptionally strong one for Depomed, both in terms of product revenue and cash flow. Our strong cash flow during the quarter reflects our first full quarter of promotion of NUCYNTA ER and NUCYNTA. As of September 30, 2015, cash, cash equivalents and marketable securities were $175 million, which represents a quarterly increase of $52 million. In the six months after the closing of the NUCYNTA acquisition we have increased cash, cash equivalents and marketable securities by approximately $107 million. As we have stated since the closing of the NUCYNTA transaction, our intent is to prepay 100 million of our secured debt in the second quarter of 2016. We remain confident in our ability to do so, while maintaining our working capital needs. Total product revenue for the quarter ended September 30, 2015 was a record $105 million, representing a year-over-year product revenue growth of 242%. Putting this into perspective, total product revenue for Q3 2013 was $16 million and for Q3 2014 $31 million. I would like to note that the days on hand at the channel at the end of Q3 remained consistent with the end of Q2 and are in the normal range of between two and three weeks. For the quarter NUCYNTA sales were 65 million, an increase of 15% from the previous quarter. Total prescriptions for the NUCYNTA franchise were over 200,000 with NUCYNTA ER prescriptions up 8% over the prior quarter and I’m happy to report that we have now reversed the decline of NUCYNTA with scripts going 1% over second quarter 2015. The rest of our products also delivered strong performance in this quarter. Our Gralise third quarter net sales were 21 million, an increase of 29% compared to third quarter of 2014. Demand was strong with total prescriptions of 83,000, up 11% compared to the same period last year. Cambia which we acquired in December of 2013 and re-launched in February 2014 had record third quarter net sales of 7 million, an increase of 21% compared to third quarter 2014. Total prescriptions of 34,000 were up 25% compared to the same period last year. Lazanda, which we acquired in late July 2013 and re-launched in October 2013, had third quarter net sales of a record high 5.4 million and increase of 139%, compared to the third quarter of 2014 and an increase of 41% compared to the second quarter of 2015. Total sprays of 157,000 in the third quarter of 2015 were up 114% compared to third quarter 2014. Now let’s look at our expense levels, selling, general and administrative expenses were 49.1 million for the third quarter of 2015. These expenses include 3.4 million of expense associated with the Company’s evaluation and consideration of the unsolicited proposals from Horizon. As we indicated in our second quarter earnings call guidance, SG&A expense for Q3 2015 is 9 million lower than Q2 2015. As Q2 expense levels included significant one-time expenses and fees related to the NUCYNTA acquisition. We expect SG&A expense for the remainder of the year to continue at approximately the same level as Q3 2015. Research and development expenses were 4.6 million for the third quarter of 2015, down slightly from Q2 2015. R&D expense in Q3 2015 resulted principally from costs associated with pediatric trials of NUCYNTA, Cambia and Zipsor. We expect R&D expense to increase during the remainder of 2015. Before I discuss our updated guidance for 2015, I want to briefly address two other topics; first, our Glumetza royalty sale to PDL and then our use of specialty pharmacies. As most of you know in October 2013, Depomed sold all rights to the royalty payments from Glumetza and our other Type II diabetes products on a non-recourse basis to PDL Biopharma receiving a payment of 240.5 million from PDL. Salix now part of Valeant sends Glumetza royalty payment to a special Depomed account and the funds are directly sent to PDL on a weekly basis. Depomed never accounts for r have access to the funds and as of the end of the 2014 Depomed no longer records any revenue related to these products. Now let’s turn to specialty pharmacies. Depomed has no ownership in any specialty pharmacy, has no option to purchase a specialty pharmacy, nor do we have any interest in doing so. Our specialty product for breakthrough cancer pain, Lazanda is regularly dispatched through specialty pharmacies just as most prescriptions are in that drug category. Total net sales of Lazanda for the quarter were 5.4 million. For our other products NUCYNTA and Zipsor are not dispensed through specialty pharmacies. For Gralise and Cambia only a small number of our prescriptions are dispensed through specialty pharmacies. The goal of that program is to allow time to fulfill any payor requests for information that are needed to adjudicate the prescription. In addition, it is intended to avoid inappropriate substitution that could happen at some retail pharmacies. As an example, a pharmacist offering a patient three-time-a-day generic gabapentin rather than filling the prescription as ordered with Gralise. Outside of Lazanda less than 2% of our total sales volume goes through specialty pharmacies and we estimate that approximately 97% of our office-based prescriptions go through the typical retail pharmacy channel. Now to our guidance, in light of our strong Q3 results we are updating our guidance for 2015. Guidance for the year is based on actual results for the first nine months of the year and our current budget for the remainder of the year. Our budget is based on a large number of assumptions and there are significant uncertainties in estimating future product revenues. This is particularly true for our largest revenue products, NUCYNTA and NUCYNTA ER. For a more complete discussion of the relevant risks relating to our guidance I direct you to the Risk Factors section of our quarterly report on Form 10-Q that we will file with the SEC today. With that said, the aggregate net product revenues for our six products for 2015 are expected to be 336 million to 348 million. This is an increase from our previous guidance of a range of 320 million to 340 million. We expect total revenues to be approximately the same as we are not anticipating any milestone revenue in 2014. COGS for NUCYNTA and NUCYNTA ER will be approximately 25% for the remainder of 2015, reflecting the manufacturing costs and the royalties on net sales owed to Grunenthal. COGS on our other products are expected to be approximately 10% of net sales. Operating expenses, exclusive of amortization are expected to be 200 million to 210 million, an increase from our previous guidance of 195 million to 210 million. SG&A expense for the remainder of the year reflects the cost associated with our increased salesforce. The additional headcount increase is necessary to support the increased salesforce and the marketing expense for both NUCYNTA and NUCYNTA ER. In addition, they reflect the expenses of the NUCYNTA and a litigation that we’ve assumed in connection with the acquisition and the expenses that we will incur in connection with the Horizon matter. Research and development expenses include pediatric studies for NUCYNTA, Cambia and Zipsor. Intangible asset amortization is expected to be approximately 84 million reflecting amortization of the NUCYNTA, Cambia, Lazanda and Zipsor acquisitions. Interest expense for the year is expected to be $73 million, this reflects the cash and non-cash interest expense on the convertible debt for the full year and the interest expense for nine months on the high yield debt that we raised in order to finance the balance of the NUCYNTA purchase price. Non-GAAP adjusted earnings are expected to be 58 million to 66 million reflecting a significant increase from our previous guidance of 40 million to 50 million, included in the non-GAAP adjusted earnings as in expected $19 million cash tax benefit related to net operating loss carry backs on taxes previously paid. Adjusted EBITDA is expected to be in the range of 108 million to 116 million, again that's an increase from our previous guidance of 95 million to 110 million. Non-GAAP adjusted earnings are not based on any standardized methodology prescribed by GAAP and represent net income adjusted to exclude amortization related to product acquisitions, stock-based compensation expense, non-cash interest expense related to convertible debt, expenses associated with the Company’s defense against the Horizon Pharma unsolicited takeover bid, and to adjusted the income tax provision to reflect the estimated amounts payable or receivable in cash. Adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net income adjusted to exclude interest income, interest expense, amortization related to product acquisitions, stock-based compensation expense, depreciation, taxes, expenses associated with the Company’s defense against the Horizon Pharma unsolicited takeover bid and transaction cost associated with product acquisitions. Non-GAAP financial measures used by Depomed maybe calculated differently from and therefore may not be comparable to non-GAAP measures used by other companies. That concludes the financial discussion. I’ll now turn the call back over to Jim.