Collegium Pharmaceutical, Inc.

Greetings and welcome to the Collegium Pharmaceutical fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during this conference call, please press star zero on your telephone keypad. Please note that this conference call is being recorded. I will now turn the call over to Christopher James, Vice President of Investor Relations at Collegium. Thank you. You may begin.

Welcome to Collegium Pharmaceuticals' fourth quarter and full year 2023 earnings conference call. I'm joined today by Joe Schifoni, our Chief Executive Officer, Colleen Tupper, 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. Your caution that such forward-looking statements involve risks and uncertainties, including and without limitation, the risk that we may not be able to successfully commercialize our products, that we may incur significant expense, and that we may not prevail in current or future litigation pertaining to our business. 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 on 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 collegianpharma.com. I will now turn the call over to our CEO, Joe Schifoni.

Thank you, Chris. Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss our performance during the fourth quarter and full year 2023 and our focus on operational execution in 2024. As we build a leading diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, we strive to do good as we do well. We are proud of our partnerships with organizations to drive equitable access to STEM education in underserved communities. As part of this commitment, we recently launched the Collegium Pharmaceutical Scholarship Program for which we will award two full scholarships to Massachusetts-based high school seniors pursuing a STEM-related major at a U.S. university. We are proud to provide this opportunity to students who have demonstrated financial need, academic achievement, leadership, community service, and a commitment to learning as they pursue a career in STEM. Also, yesterday we published our 2023 ESG report which reflects our commitment to operating with responsibility, integrity, and purpose. I encourage you to read the report on our website. I'd also like to recognize the Collegium team for their commitment to our mission and for their contributions and accomplishments in 2023. 2023 was a banner year for Collegium Pharmaceutical. We delivered on our financial commitments and executed our capital deployment strategy. Key accomplishments in 2023 include we delivered record revenue and record adjusted EBITDA. We returned Belbuca to sequential quarterly prescription growth starting in Q2 2023 and saw year-over-year quarterly growth in Q3 and Q4. In the fourth quarter, Belbuca total prescriptions grew 3.2% compared to Q4 2022. We expect to see Belbuca prescription growth in 2024. We successfully renegotiated a major Medicare Part D plan accounting for 12% of Belbuca prescriptions, maintaining access, and materially rolling back rebates. This will result in year-on-year gross to net improvement. We also want new Medicare Part D plan representing approximately 1 million covered lives. We improved Xtamsa ER gross net in 2023 to 59.6%, a decrease of 9.7 percentage points over 2022. We successfully renegotiated contracts representing 30% of all Xtamsa ER prescriptions, maintaining access and improving rebates in 57% of plans. We expect to see gross net improve to 56 to 58% in 2024. We received new patient population exclusivity for Nuscenta, extending the period of U.S. exclusivity from June 27th, 2025 to July 3rd, 2026. We submitted a pediatric extension for the Nuscenta franchise in December that if approved will extend exclusivity of the franchise an additional six months. We expect a decision in the second half of 2024. The new patient population exclusivity for Nusenta, together with the potential pediatric extension for the Nusenta franchise, bolster our outlook in 2025 and 2026. We executed our capital deployment strategy, paying down $162.5 million in debt and returning $75 million in capital to our shareholders through our share repurchase program. and we ended the year with over $310 million in cash and marketable securities. Our record financial performance and operational achievements in 2023 position the organization for success in 2024 and beyond. We expect to deliver record revenue, adjusted EBITDA, free cash flow, and net income in 2024. In 2024, top-line growth will be fueled by Belbuca and Xtamsa ER. We are encouraged by the Belbuca prescription growth we saw in the fourth quarter of 2023, and we expect to see full-year prescription growth in 2024, along with gross-to-net improvement. Over the past two years, we renegotiated contracts representing 84% of all Xtamsa ER prescriptions, maintaining access, and rolling back rebates in 77% of plans. This is a major accomplishment, that will fuel extensive ER revenue growth in 2024. We expect gross net to improve to 56 to 58%. The team is working hard to mitigate anticipated pressure on prescriptions. The Nuscenta franchise is a key contributor to our pain portfolio. We do expect some pressure on Nuscenta franchise revenue in 2024 because of the American Recovery Act eliminating the Medicaid cap. Beginning in 2025, through loss of exclusivity, we expect to be able to deliver relatively stable year-on-year results. The new population exclusivity achieved for Nuscenta in 2023 and the anticipated pediatric extensions for the franchise in 2024, along with a reduction in the royalties we pay on Nuscenta franchise sales from 14% to 7% beginning on June 27, 2025, bolster our outlook for the franchise in 2025 and 2026. In 2024, our focus is on operational execution. We are committed to achieving our financial objectives and deploying capital to create long-term value for our shareholders. We aim to achieve record financial performance while rapidly paying down debt, and returning capital to our shareholders by opportunistically leveraging our $150 million share repurchase program. I am confident that we are well positioned to deliver on our financial and capital deployment objectives. I will now hand the call over to Colleen to discuss the financials.