Collegium Pharmaceutical, Inc.

Greetings and welcome to Collegium Pharmaceutical third quarter 2021 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Julie Fallon. Thank you. You may begin.

Welcome to Collegium Pharmaceutical's third quarter 2021 earnings conference call. This is Julie Fallon on behalf of Collegium. 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. You are cautioned that such forward-looking statements involve risks and uncertainties, including and without limitation, the risk that we may not be able to successfully commercialize Extensa ER and the Nuscenta 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 CEO, Joe Schifoni.

Thank you, Julie. Good afternoon, and thank you, everyone, for joining the call. Today we will discuss our performance in Q3 and through the first nine months of the year, in addition to our near-term outlook. At Collegium, we remain focused on our mission of being the leader in responsible pain management, and we are committed to driving growth in our business and creating value for shareholders. We will do this by maximizing the potential of our differentiated portfolio of pain products, achieving our operational and financial goals, deploying our balance sheet, and strategically investing in our long-term growth. In the face of challenging market dynamics throughout 2021, inclusive of the third quarter, we are making progress against our full-year operational objectives and are on track to achieve record total revenue, net income, and adjusted EBITDA. As we have consistently emphasized throughout the year, COVID-19 dynamics have adversely impacted the mix of Xtamsa ER prescriptions, pressuring gross to net beyond plan, and negatively impacting Xtamsa ER revenue. This dynamic continued in the third quarter. Conversely, the Nuscenta franchise has benefited from continuity of care and gross to net favorability. We expect to deliver total revenues of $330 to $340 million in 2021 achieved differently than initially anticipated. Total revenue operating expenses and Adjusted EBITDA continue to track to the overall expectations that we communicated in January. Colleen will share our updated 2021 guidance. We believe that we are embarking on a phase of growth and value creation for the organization, and I remain confident in the underlying strength of our differentiated pain portfolio and the opportunities we have ahead to meet our operational and financial objectives and to deliver value for our shareholders in the near and long term. Notable accomplishments in the first nine months of 2021 include, we posted record total revenue, net income and adjusted EBITDA. Xtamsa ER market share increased to 32.5%. We grew NuCenta franchise net revenue to over $150 million, a level not seen in the first nine months of a year since 2018. We delivered on our commitment to leverage, not grow our cost structure. We further strengthened our financial position and efficiently deployed our balance sheet to pay down debt and return capital to shareholders through share repurchases. We demonstrated our commitment to leading with science through publications and the sponsorship of four poster presentations at Payne Week, all of which highlight important Real-World Data Related to the Use, Misuse, Abuse, and Diversion of Xtamsa ER and the Nucenta Franchise. And we supported our communities through contributions to Science from Scientists and Life Science Cares, two organizations with missions that we are passionate about, STEM education and eliminating the impacts of poverty. For the remainder of 2021, we are focused on maximizing the value of our pain portfolio, Achieving our operational and financial goals, deploying our balance sheet efficiently and effectively, and actively pursuing business development opportunities that will help build and diversify our business longer term. Moving forward, we expect to grow Xtamsa ER revenue by growing total prescriptions, improving mix, and optimizing existing payer contracts. We will manage Xtamsa ER gross to net to less than 65% beginning in 2023. Scott will provide more detail on this topic during his update. The NuSynta franchise is well positioned to deliver relatively stable revenue on a going forward basis. As we have demonstrated, we will offset pressure on prescriptions with net price favorability. We are absolutely committed to leveraging not growing our cost structure Specifically, operating expenses excluding stock-based compensation and generating strong net operating cash flows. As it pertains to deploying our balance sheet, we are focused on creating value for our shareholders both in the near and long term. Executing on business development transactions that will build and diversify the business is our number one priority. We are also returning capital to shareholders through share repurchases. Our share repurchase program, announced on August 16, enables us to purchase up to $100 million of our shares, and we have been active buyers of our stock since its inception. We believe in the long-term success of our company and that our stock, at current valuation, represents a very attractive investment with a favorable return profile for investors. As such, we announce today that as part of our repurchase program, our board has authorized us to enter into a $25 million accelerated share repurchase program, reinforcing our commitment to deliver value to our shareholders through effective balance sheet deployment. Our business development strategy is to diversify the organization in one or more of the following ways. diversifying within pain through commercial stage high synergy acquisitions, diversifying beyond pain through commercial stage lower synergy acquisitions, and diversifying into non-opioid pain solutions through the acquisition of late stage development assets defined as phase two or later that have the potential to generate revenue in the 2025 to 2027 timeframe. We are highly active on multiple business development fronts. The strength and durability of our business allows us to be disciplined in our approach. That being said, business development is our top priority. In summary, in the face of challenging market dynamics, our business is strong, and I am confident in our ability to drive growth in our existing pain portfolio, deliver on our operational and financial objectives, effectively deploy our balance sheet and strategically invest in our long-term growth. I will now hand the call over to Colleen for a discussion of the financials.