Methylphenidate Hydrochloride

STOUGHTON, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced its Board of Directors has authorized a new share repurchase program to repurchase up to $150 million in common stock through December 31, 2026. This program replaces a previous $150 million share repurchase program authorized in January 2024 which expired on June 30, 2025, and had $65 million remaining under the program. “Collegium’s strong financial position provides us with significant flexibility in executing our capital allocation strategy,” said Colleen Tupper, Chief Financial Officer. “The Board’s authorization of a new $150 million share repurchase program further supports our commitment to returning value to shareholders. We remain confident in our future growth trajectory and are committed to generating additional value as we invest in our key product growth drivers, diversify our portfolio through disciplined business development, rapidly pay down debt and opportunistically repurchase shares.” Collegium has returned $222 million in value to shareholders under its share repurchase programs since 2021, including $25 million repurchased through an accelerated share repurchase program that was initiated in May 2025 and is expected to be completed in the third quarter of 2025. As of March 31, 2025, Collegium had approximately 32.1 million shares outstanding. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and recently acquired Jornay PM®, a treatment for ADHD, establishing a presence in neuropsychiatry. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contacts:Ian KarpHead of Investor Relationsir@collegiumpharma.com Danielle JesseDirector, Investor Relationsir@collegiumpharma.com Media Contact:Cheryl WheelerHead of Corporate Communicationscommunications@collegiumpharma.com

The FDA issued mandatory labelling revisions for all extended-release stimulant medications used in the treatment of attention deficit hyperactivity disorder (ADHD) after clinical data highlighted increased weight loss risks and adverse reactions in younger children.The decision specifically targets the common off-label practice of prescribing extended-release formulations of stimulants to children below six years of age, although not approved for this age group.Following a comprehensive assessment of clinical trial data from extended-release amphetamine and methylphenidate formulations, the FDA noted that recipients under six years carried a greater risk of weight loss compared with their older paediatric counterparts receiving identical dosages of these products. “Clinically significant weight loss (at least 10% decrease in the Centers for Disease Control and Prevention weight percentile) was observed in both short- and long-term studies,” the US regulator stated.Moreover, younger children exhibited significantly higher plasma exposures and elevated adverse reaction rates than older children. The agency concluded that the risk-benefit profile may not favour extended-release stimulant use in this vulnerable population, prompting the mandatory labelling requirements.The FDA now requires manufacturers to incorporate a “Limitation of Use” section within the prescribing information of these products if not present, while labels already carrying it need revision to maintain consistency across the drug class.Meanwhile, healthcare professionals are advised to monitor growth and development closely in affected patients, considering treatment discontinuation or switching to alternative therapies, including immediate-release formulations or behavioural interventions, when weight loss or other adverse events occur.