Collegium Pharmaceutical, Inc.

Good day, ladies and gentlemen, and welcome to the Q4 2018 Collegium Pharmaceuticals, Inc. earnings conference call. Currently, all participants are on the listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. Should anyone require assistance at any time during the conference, please first start at zero on your touchstone telephone. Also, as a reminder, this conference call is being recorded. At this time, I'd like to turn the call over to your host, Alex Basala, Head of Investor Relations. Please go ahead.

Welcome to the Collegium Pharmaceutical fourth quarter 2018 earnings conference call. This is Alex Basara, head of investor relations for Collegium. I am joined today by Joe Schifoni, our chief executive officer, Paul Brinley, 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, expand the ER, and the new central 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.

Thank you, Alex. Good afternoon, and thank you, everyone, for joining the call. 2018 was a transformative year for Collegium. Fueled by exclusive ER oxycodone payer wins and improved operational execution, Extamsa ER total prescriptions grew 233%, and Extamsa ER was the fastest-growing extended-release opioid in 2018. Extamsa ER net revenue grew $69.4 million in 2018, representing a 144% increase versus 2017. The acquisition of the U.S. commercialization rights to the Broaden the Collegium portfolio, increase Collegium's relevance to all stakeholders, and achieve the financial objectives of expanding Collegium's revenue base, being a creative in 2018, and accelerating time to profitability. Collegium achieved full-year net revenue of $280.4 million, up 885% versus 2017. Cash burn improved each quarter in 2018. and for the eighth consecutive quarter overall. Collegium ended the year with $146.6 million of cash on hand, exceeding our guidance of $145 million. The Expanse ER patent estate was strengthened with the addition of two Orange Book listed patents in 2018, bringing the total to 14. We made significant investments in personnel, systems and processes Collegium Pharmaceutical is focused on and well positioned to become the leader in responsible pain management. We believe that 2019 will be a breakthrough year for collegium. We expect Xtamsa ER total prescriptions to accelerate as a result of 13 new exclusive ER oxycodone payer wins that took effect on January 1, 2019. 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. The amended Nuscenta commercialization agreement will significantly improve Collegium's economics versus the original agreement at the level of sales that we've guided to in 2019. We are focused on leveraging, not adding to, the cost structure of the organization and anticipate operating costs will be flat in 2019 versus 2018. Revenue growth driven by Xtamsa ER and financial discipline will drive the breakthrough year that we're striving for in 2019. The strategic plan that we developed in 2018 will guide our actions in 2019 and beyond. Our strategic vision is clear. Collegium aspires to be the leader in responsible pain management. We're focused on bringing innovative and differentiated assets to the U.S. market, including non-opioid therapies. We will leverage our strengths in developing late-stage clinical programs and commercializing products that are relevant to office-based pain specialists. This will result in Collegium being a growth stage company with a balanced portfolio of on-market and in-development pain assets. In building Collegium's strategic plan, we focused on three major work streams. The first was the development of the five-year financial trajectory of the organization. At a high level, we anticipate that our current marketed portfolio will generate significant cash driven by Xtansa ER. We believe that Xtansa ER will become the number one prescribed ER oxycodone. Second, we identified our development and commercial functions as areas of strength and competitive differentiation. Our focus will be on the U.S. market and office-based pain specialists. We will strive to acquire commercial and later stage development assets post phase two that we believe are innovative and or differentiated. Our primary focus will be on novel non-opioid programs that have the potential to generate revenue as early as 2022. 2018 was a transformative year for Collegium Pharmaceutical. We're proud of the progress that we made. 2019 has the potential to be a breakthrough year for the organization. Early on, we're encouraged by the trends, but we recognize that we have a lot of work to do. I'm confident that the collegium team is up to the challenge. Last but certainly not least, I want to take a moment to recognize the accomplishments of my colleagues at collegium as we strive to become the leader in responsible pain management. I also want to thank them for the effort that they put forth every day and for their commitment to making a positive difference in the lives of people suffering from pain and the communities that we serve. I will now hand the call over to Paul.