Collegium Pharmaceutical, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2019 Collegium Pharmaceutical Earnings Conference Call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0 to reach an operator. I would now like to hand the call over to Alex Desala. Please go ahead.

Welcome to Collegium Pharmaceutical's third quarter 2019 earnings conference call. This is Alex Desala, Head of Investor Relations for Collegium. I am joined today by Joe Schifoni, our Chief Executive Officer, Paul Brantley, 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. We 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 Nucenta franchise. and that we may incur significant expense and may not prevail in current or future opioid industry litigation and investigations, patent infringement litigation or other litigation pertaining to our products. 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 press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on our corporate website at collegiumpharma.com. I will now turn the call over to Collegium's CEO, Joe Schifoni.

Thanks, Alex. Good afternoon and thank you everyone for joining the call. We're pleased to report that we're on track to make 2019 a breakthrough year for Collegium Pharmaceutical. We continue to make meaningful progress against our key strategic and operational priorities, and our organization is focused on finishing strong in 2019. Accomplishments for the third quarter include net revenue of $72.9 million, which represents a 4% increase over the third quarter of 2018. Exfamsa ER third quarter net revenue increased to $26.5 million, which represents a 56% increase versus the third quarter of 2018. Xtamsa ER total prescriptions grew 44% in comparison to the third quarter of 2018. As anticipated, Xtamsa ER grew at a moderated rate on a sequential basis and we expect prescriptions to grow at a similar rate in the fourth quarter. As a reminder, Xtamsa ER prescription growth in 2019 was driven by 13 new exclusive eroxycodone payer wins representing approximately 11 million lives that took effect on January 1, 2019. OpEx for the quarter was down in comparison to the third quarter of 2018. We remain committed to leveraging, not growing, Collegium's cost structure in 2019 and beyond. On a non-GAAP basis, we generated income from operations for the second consecutive quarter and increased cash on hand. Finally, we strengthened the leadership team with the appointment of Bart Dunn to the role of Executive Vice President, Strategy and Corporate Development, and member of the Executive Committee. Bart will lead the execution of our midterm growth strategy. As it pertains to the ongoing industry-wide opioid litigation, We have no material updates to provide from our last call. Our quarterly report as always includes details of all of our pending litigation matters. As a brief recap, as of today, there are over 2,600 lawsuits against manufacturers, distributors, and others relating to prescription opioids. Of these, we are aware of 26 in which we are currently named. Where we have an opportunity to do so, we are pursuing dismissal based on Collegium's late entry to the market, and the absence of allegations that we engaged in conduct that resulted in the abuse, misuse, or diversion of our products. Four of the 26 cases in which we are named are in the multi-district litigation, and none of them are a track or bellwether case. So we do not expect to have engagement in the MDL for some time. Finally, we did not assume any liability for Nuscenta promotion or sales that occurred prior to January of 2018. Looking forward to 2020, we believe that Xtamsa ER is well positioned to take a significant step towards becoming the number one prescribed ER oxycodone. I am excited to report that Collegium's market access team has secured additional exclusive ER oxycodone formulary wins that cover over 35 million predominantly commercial lives. This is a major accomplishment. These wins all take effect on January 1st, 2020. Our commercial team is preparing to successfully pull through these new opportunities while leveraging Xtamsa ER's existing exclusive coverage and broad availability to fuel the next stage of growth. Collegium Pharmaceutical is committed to its mission of becoming the leader in responsible pain management. In addition, we're confident that Xtamsa ER is well positioned to become the branded market leader no later than 2023. We're encouraged by the progress that we've made in 29 and we recognize that we have a lot of work to do. were focused on finishing strong in 2019, while at the same time preparing for a strong start to 2020. I will now hand the call over to Paul for a discussion of the financials.