Table of Contents As of June 30, 2023, none of the above circumstances had occurred and as such, the 2026 Convertible Notes could not have been converted. (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (2) the trading day immediately before the date the Company sends such notice. The 2026 Convertible Notes have customary default ...

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Christopher James - Vice President, Investor Relations Joe Ciaffoni - Chief Executive Officer Colleen Tupper - Chief Financial Officer Scott Dreyer - Chief Commercial Officer Conference Call Participants David Amsellem - Piper Sandler Tim Lugo - William Blair Brandon Folkes - Cantor Fitzgerald Serge Belanger - Needham & Company Greg Fraser - Truist Securities Glen Santangelo - Jefferies ...

On February 25, 2022, in connection with the BDSI Acquisition, a purported individual stockholder of BDSI filed a complaint in the United States District Court for the Southern District of New York, captioned Stein v. BioDelivery Sciences International, Inc., et al., No. 1:22-cv-01600, naming as defendants BDSI and each member of its Board of Directors as of the date of the Merger Agreement ("Stein Action"). On February 28, 2022, two additional cases were filed by purported individual stockholders of BDSI i ...

Forward-Looking Statements To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We use these non-GAAP financial measures to understand, manage and evaluate our business as we believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAAP, provide analysts, investors, lenders and other third p ...

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Christopher James - Vice President of Investor Relations at Collegium Pharmaceuticals Joe Ciaffoni - Chief Executive Officer Colleen Tupper - Chief Financial Officer Scott Dreyer - Chief Commercial Officer Conference Call Participants David Amsellem - Piper Sandler Brandon Folkes - Cantor Fitzgerald Serge Belanger - Needham & Company Greg Fraser - Truist Operator Greetings, and we ...

Financial Performance - For the fiscal year ended December 31, 2022, the company generated $463.9 million in net revenues across its portfolio[19]. - Three customers accounted for over 10% of revenue in 2022, contributing 33%, 33%, and 31% of total revenue respectively[66]. - The 2022 Term Loan has an outstanding principal amount of $575.0 million, with a hypothetical 1% increase or decrease in interest rates affecting future interest expense by approximately $5.8 million[670]. Product Development and Acquisitions - The company acquired BioDelivery Sciences International, Inc. on March 22, 2022, gaining products such as Belbuca, Symproic, and Elyxyb[17]. - Xtampza ER, an abuse-deterrent formulation of oxycodone, was commercially launched in June 2016 and is designed to address the opioid epidemic[15]. - The company discontinued commercialization of Elyxyb in Q4 2022 and transferred related assets to a third party in Q1 2023[18]. - Xtampza ER was commercially launched in June 2016 and is the only extended-release oxycodone product with oral, intranasal, and intravenous abuse-deterrent labeling as of January 2023[42][43]. - The Nucynta Products, including Nucynta ER and Nucynta IR, were commercialized starting in 2018, with a 14% royalty obligation on net sales to Grünenthal GmbH[49][50]. Market and Regulatory Environment - The FDA has encouraged the development of abuse-deterrent formulations to combat the opioid crisis, which includes the company's DETERx platform[32]. - The FDA approved a class-wide REMS for extended-release and long-acting opioid products in July 2012, aimed at educating healthcare providers on treatment and monitoring of pain patients[83]. - The FDA announced a meeting on April 19, 2023, to discuss post-marketing requirements for extended-release and long-acting opioid analgesics[87]. - The FDA requires post-market testing and surveillance for approved products, which may include conditions that restrict distribution or use[148]. - The DEA is lowering the supply of Schedule II opioids, including an average decrease in oxycodone and tapentadol of approximately 6% in 2023[158]. - Xtampza ER and Nucynta Products are classified as Schedule II controlled substances, subjecting them to the strictest registration and reporting requirements[157]. - The company must submit annual applications to the DEA for individual production and procurement quotas for Schedule II substances[158]. Pain Management and Public Health - In 2022, approximately 145.1 million prescriptions for opioids were written in the United States, representing a 5% decline from 2021 levels[25]. - The overall prevalence of chronic pain among adults in the United States is 20.4%, affecting approximately 50 million Americans[22]. - The estimated annual costs of chronic pain in the U.S. exceed $560 billion, surpassing costs for heart disease, cancer, and diabetes[23]. - The opioid overdose epidemic has led to over 48,000 deaths from synthetic opioids in 2022, highlighting the ongoing public health issue[29]. - Symproic, approved in March 2017, is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain[60]. Corporate Governance and Social Responsibility - The company published its inaugural ESG report in February 2023, highlighting its ESG accomplishments and focus[143]. - The company is committed to corporate social responsibility (CSR) activities and has included metrics related to specific ESG initiatives in its annual Corporate Scorecard[176]. - The company established a Diversity, Equity, and Inclusion (DEI) Council in June 2020 to improve diversity at all levels within the organization[184]. - The company is developing an action plan to monitor resource use throughout the value chain and reduce environmental impacts[188]. Employee and Operational Insights - The company employs approximately 120 sales representatives targeting 8,600 healthcare professionals who write about 62% of branded extended-release opioid prescriptions in the U.S.[56]. - The company had 90 new hires in 2022, with a voluntary turnover rate of 28.3% in the home office and 38.8% in the field[181]. - The company has implemented tools for employee development, focusing on regular feedback and creating Individual Development Plans[182]. Challenges and Legislative Impact - The company is facing pricing pressures in the pharmaceutical industry due to managed healthcare trends and legislative proposals, which could adversely affect operations[168]. - The Affordable Care Act has resulted in reductions to Medicare payments to providers of up to 2% per fiscal year, effective through 2030[139]. - The Inflation Reduction Act of 2022 includes substantial drug pricing reforms, establishing a drug price negotiation program within the U.S. Department of Health and Human Services[140]. - The repeal of the individual mandate under the Tax Cuts and Jobs Act is estimated to result in over 13 million Americans losing health insurance coverage over the next ten years, potentially impacting the company's financial operations[173]. - The Affordable Care Act has faced legal challenges, but the Supreme Court ruled that plaintiffs lacked standing to challenge the law, leaving its provisions intact[172]. Intellectual Property and Market Position - Xtampza ER is protected by nineteen issued patents in the U.S., with expiration dates ranging from 2023 to 2036, and additional pending applications[67]. - Nucynta is protected by one issued patent projected to expire in 2025, while Nucynta ER has seven patents expiring between 2023 and 2028[100]. - The company owns all rights to Xtampza ER and has received trademark registrations for its products, enhancing its competitive position[101]. - The Hatch-Waxman Amendments provide exclusivity periods for new chemical entities and changes to approved drugs, impacting market competition[152].

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Dawn Schottlandt - Managing Director-Argot Partners Joe Ciaffoni - Chief Executive Officer Colleen Tupper - Chief Financial Officer Scott Dreyer - Chief Commercial Officer Conference Call Participants David Amsellem - Piper Sandler Tim Lugo - William Blair Brandon Folkes - Cantor Fitzgerald Serge Belanger - Needham & Company Greg Fraser - Truist Securities Oren Livnat - H.C. Wainwri ...

November 3, 2022 | Nasdaq: COLL Q3FY22 Earnings Report | --- | --- | |----------------------------|-------| | | | | Forward-Looking Statements | | Non-GAAP Financial Measures | --- | --- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37372 Collegium Pharmaceutical, Inc. (Exact name of registrant as specified in its charter) Virginia (Sta ...

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q2 2022 Results Conference Call August 4, 2022 4:30 PM ET Company Participants Alex Dasalla - Head, IR Joseph Ciaffoni - CEO Colleen Tupper - CFO Scott Dreyer - CCO Conference Call Participants Greg Fraser - Truist David Amsellem - Piper Sandler Serge Belanger - Needham & Company Tim Lugo - William Blair Operator Greetings, and welcome to the Collegium Pharmaceutical Second Quarter 2022 Earnings Call. [Operator Instructions] Please note that this conference is be ...