Paul Brannelly
Analyst · Piper Jaffray. Your line is now open
Thanks, Joe. Good afternoon, everyone. Before discussing quarterly results, I’d like to spend a moment describing the amendment to the Nucynta commercialization agreement with Assertio. The most significant change is the removal of the guaranteed annual minimum royalty obligation of $135 million and switching to a tiered royalty structure. Importantly, the amended terms increase Collegium’s net cash flows from the deal with all net revenue numbers. We expect to improve our balance sheet by substantially reducing the $400 million asset acquisition obligation and benefit from a more tax efficient structure. In exchange for these significant benefits, we eliminated our rights to terminate the deal through the original initial four-year term of the deal. In addition to the change in termination rights, we issued Assertio a four-year warrant to purchase 1,042,000 shares common stock at an exercise price of $19.20, which is a 23% premium to our current stock price. The revised terms include Collegium’s net cash flow by up to approximately $9 million a year for net sales below $233 million, while providing additional incentives to grow the Nucynta franchise with lower royalties and net sales above $233 million. This amendment builds on our strong relationship with Assertio by recognizing the impact of the supply disruption. Importantly, the revised terms allow us to continue to meet our main objective in the original deal, accelerating our time to profitability. For additional details, please see our Form 8-K that was filed with the SEC this afternoon. For the third quarter of 2018, we recorded net product revenue of $70.2 million compared to $12 million in the third quarter of 2017 and $73.1 million in the second quarter of this year. For the third quarter, net product revenue was $17 million for Xtampza and $532 million for the Nucynta franchise. Xtampza ER prescriptions grew by 8% during the quarter, but net product revenue was negatively impacted by: one, an increase in gross-to-net discount as a result of an increase of Medicare coverage gap estimates for the current and prior quarters; two, a change in the dose mix ordered by wholesalers with the two highest doses decreasing in average of 7%, while wholesaler orders for the lowest three doses increased. This shift better aligns wholesaler ordering to prescription demand; and finally, three, in addition, the second quarter of 2018 included a positive adjustment for prior period commercial and Medicare Part D rebates, while the third quarter only included minor adjustments. The gross-to-net discount of our combined portfolio was 53.9% in the third quarter of 2018 compared to 55.4% in the first quarter of 2018 and 52.3% in the second quarter of 2018. For the remainder of 2018, we expect the gross-to-net discount to remain around 55% on a portfolio basis. On a product basis, we expect the gross-to-net discount for Xtampza ER to be in the low 60% range and the Nucynta franchise to be closer to 52%. For the third quarter, our net loss was $16.5 million compared to $13.3 million for the prior year quarter, resulting in a net loss per share of $0.50 and $0.45 for the 2018 and 2017 quarters, respectively. The 2017 quarter included a one-time $4.4 million increase in net product revenue as a result of the Company’s change to the selling method. In order to supplement our GAAP financial statements, we included non-GAAP adjusted loss in our earnings press release and 10-Q. We believe that the non-GAAP adjusted loss provides investors insight into management’s view of the Company’s core operating performance. The non-GAAP adjusted loss for the third quarter of 2018 was $8.3 million, which is an improvement from $11.2 million in the third quarter of 2017. Non-GAAP adjusted loss is calculated by adjusting our net loss by excluding stock-based compensation of $3.7 million and non-cash Nucynta deal-related expenses, including non-cash interest charge of $5.6 million, and adding back the actual Nucynta royalties. As of September 30, our cash balance was $139.8 million, an increase of $21.1 million from December 31 and $6 million from June 30. This marks the seventh consecutive quarter of improving cash flows after adjusting for stock offerings and term loan draw downs. Based on our current operating plans, we expect to finish the year with at least $145 million in cash, an increase from our prior guidance of $135 million. I will now turn the call over to Scott Dreyer for a commercial update.