Collegium Pharmaceutical, Inc.

Ladies and gentlemen, and welcome to the Collegium Pharmaceutical's first quarter 2019 earnings conference call. At this time, all participants are on a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance during the call, please press start and the zero on your touch-tone telephone. As a reminder, this call may be recorded. I would now like to introduce yours for today's conference, Ms. Alex DeSalem. May we begin? Thank you.

Welcome to the Collegium Pharmaceutical First Quarter 2019 Earnings Conference Call. This is Alex Basala, Head of Investor Relations for Collegium. I am joined today by Joe Schifoni, our Chief Executive Officer, Paul Branley, our Chief Financial Officer, and Scott Dreyer, our Chief Commercial Officer. Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional. and that any forward-looking statements made today are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties, including and without limitation, the risks that we may not be able to successfully commercialize Xtamsa ER and the Nusenta franchise and that we will incur significant expense and may not prevail in current or future patent infringement litigation or other litigation pertaining to our products and product candidates. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Our future results may differ materially from our current expectations discussed today. Our earnings release and this call will include discussion of certain non-GAAP information. You can find our earnings release, including relevant non-GAAP reconciliations, on our corporate website at collegiumpharma.com. I will now turn the call over to Collegium CEO, Joe Schifoni.

Thanks, Alex. Good afternoon, and thank you everyone for joining the call. We believe that 2019 will be a breakthrough year for Collegium Pharmaceutical. We are encouraged by our performance in the first quarter and confident that Collegium is well positioned to become the leader in responsible pain management. We remain laser focused on our key priorities for 2019, which are to leverage exclusive ER oxycodone payer wins to accelerate extensa ER, maximize the value of the Nuscenta franchise, strengthen operational execution, leverage, not add to our cost structure, and execute our midterm growth strategy. Financial highlights for the first quarter include net revenue of $74.5 million, up 17% versus Q1 2018. Xtamsa ER revenue of $25.1 million, up 59% versus Q1 2018. Xtamsa ER total prescriptions were 105,309, up 71% versus the first quarter of 2018. Driven by 13 new exclusive ER oxycodone pair ones that took effect on January 1st, Xtamsa ER continues to be the fastest growing branded ER opioid. As was the case in 2018, we anticipate a faster rate of growth in the first half of the year, followed by sustained growth at a moderated rate in the second half of 2019. Nuscenta franchise revenue was $49.4 million, up 3% versus Q1 2018. Nuscenta franchise prescriptions were down 10% versus Q4 2018. First quarter seasonality due to high deductible commercial plans is the primary driver of the decline. We expect to grow Nucenta ER prescriptions sequentially and to moderate the rate of IR decline over the remainder of 2019. Other accomplishments in the quarter include the appointment of Dr. Richard Malamut to the role of Chief Medical Officer and member of the Executive Team. Richard has extensive experience in pain and across all stages of drug development. He will play a key role in the execution of our midterm growth strategy. In the first quarter, a new patent covering Xtansa ER was added to the FDA Orange Book with an expiry date in 2036. With this addition, Xtansa ER now has 15 Orange Book listed patents, enhancing an already strong portfolio. As it pertains to our midterm growth strategy, we're actively pursuing later stage development assets that we believe are innovative and differentiated. Our primary focus is on non-opioid pain programs that have the potential to generate revenue as early as 2022. Collegium's focus on the U.S. market, credibility with office-based pain specialists, and development in commercial capabilities are areas of strength and competitive differentiation. Collegium Pharmaceutical is committed to becoming the leader in responsible pain management. Today our portfolio consists of Xtamsa ER, Nucenta ER, and Nucenta IR, products that pain specialists view favorably and as differentiated. Our portfolio compels us to step into the pain market at a time when others have opted to step out. We continue to invest in personnel, systems, and processes to enable us to achieve our mission. We recognize the importance of earning the trust of key stakeholders every day. were encouraged by our performance in the first quarter and focused on accelerating extantia ER and maximizing the value of the Nucenta franchise for the remainder of 2019. At the same time, we will continue to work hard to position Collegium to usher in a next generation of non-opioid pain solutions in the U.S. market. On a final note, I would like to take a moment to thank and recognize my colleagues at Collegium for all that they do to make a positive difference in the lives of people suffering from pain in our communities. I'm confident that we have the team in place that will enable Collegium to become the leader in responsible pain management. I will now hand the call over to Paul.