Core Points - Collegium Pharmaceutical, Inc. announced significant changes to its Board of Directors and executive leadership team as part of a new growth phase [1][2][3] Board of Directors Changes - Michael Heffernan, Founder and Chairman, and Gwen A. Melincoff, Board Member, will retire at the Annual General Meeting (AGM) on May 15, 2025 [2] - Gino Santini, the Board's Lead Independent Director, will be appointed as the new Chairman [2] - Dr. Carlos Paya has been nominated to the Board for shareholder approval at the AGM [2] Executive Leadership Appointments - David Dieter has been appointed as Executive Vice President, General Counsel [1][4] - Jane Gonnerman has been appointed as Executive Vice President, Strategy and Corporate Development [1][4] - Dean J. Patras has been appointed as Chief People Officer [1][4] Leadership Experience - Dr. Carlos Paya brings over 30 years of experience in the biopharmaceutical industry, previously serving as CEO of Immune Design Corp. and holding senior roles at Elan Pharmaceuticals and Eli Lilly [4][5] - David Dieter previously served as Vice President, Legal at Horizon Therapeutics, managing corporate and commercial legal matters [6] - Jane Gonnerman was Senior Vice President at Amgen, responsible for the rare disease portfolio and played a key role in the $28 billion sale of Horizon to Amgen [7] - Dean J. Patras held leadership roles at Amgen and Horizon, focusing on human resources integration following acquisitions [8] Company Strategy - Collegium aims to enhance its growth by focusing on its pain management portfolio and the recently acquired Jornay PM, a treatment for ADHD [4][9] - The company is committed to improving the lives of individuals with serious medical conditions through its diversified biopharmaceutical offerings [9]

Core Insights - Collegium Pharmaceutical, Inc. is presenting real-world data on its ADHD treatment Jornay PM at the NAPNAP conference, highlighting its commitment to improving patient outcomes [1][2] Company Overview - Collegium Pharmaceutical is focused on developing differentiated medicines for serious medical conditions, with Jornay PM as a key product in its portfolio [2][15] - The company aims to grow its commercial portfolio and establish a presence in neuropsychiatry through the acquisition of Jornay PM [15] Product Information - Jornay PM is a central nervous system stimulant indicated for the treatment of ADHD in patients aged six years and older [5][14] - The product is designed to help increase attention and decrease impulsiveness and hyperactivity in individuals with ADHD [14] Conference Details - The NAPNAP 46 National Conference on Pediatric Health Care is being held in Chicago from March 10-13, 2025, where Collegium will showcase two poster presentations [1][3] - The posters will cover real-world persistence and adherence, as well as utilization data for delayed-release/extended-release methylphenidate from a large US claims database [3]

Company Overview - Collegium Pharmaceutical, Inc. (NASDAQ: COLL) is a specialty pharmaceutical company with a strong history in drug commercialization and growth [1] - The company's primary focus is on non-abusive painkillers, and it has recently expanded its portfolio to include an ADHD medication [1] Leadership and Expertise - Sunshine Kapital's Stefan, with a BA in Finance from Halmstad University and Lincolnshire & Humberside University, has twenty years of institutional experience in Research and Portfolio Management [1] - Stefan specializes in distressed situations and value opportunities and is the CIO/Founder of Sunshine Kapital, a registered investment adviser based in Miami [1]

STOUGHTON, Mass., March 04, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced that management will participate in investor meetings at the following investor conferences: Leerink Partners 2025 Global Healthcare ConferenceTuesday, March 11, 2025 Jefferies Biotech on the Beach SummitWednesday, March 12, 2025 Barclays 27th Annual Global Healthcare ConferenceThursday, March 13, 2025 About Collegium Pharmaceutical, Inc.Collegium is building a leading, diversified biopharmaceu ...

Financial Data and Key Metrics Changes - In Q4 2024, net product revenues reached a record $181.9 million, up 22% year-over-year [42] - For the full year 2024, net product revenues were a record $631.4 million, up 11% year-over-year [42] - Adjusted EBITDA grew by 9% year-over-year, reaching a record $401.2 million for 2024 [47] - GAAP net income for Q4 was $12.5 million, down from $31.9 million in Q4 2023, while full year net income was $69.2 million, up from $48.2 million in 2023 [46] Business Line Data and Key Metrics Changes - Jornay PM generated net revenue of $29.3 million in Q4 2024, with full year pro forma net revenue of $100.7 million [42][49] - Belbuca achieved net revenue of $55.2 million in Q4 2024, up 12% year-over-year, and $211.3 million for the full year, up 16% year-over-year [43] - Xtampza ER net revenue was $51.5 million in Q4, up 6% year-over-year, and $191.3 million for the full year, up 8% year-over-year [44] - Nucynta franchise net revenue was $41.8 million in Q4, down 11% year-over-year, and $176.5 million for the full year, down 7% year-over-year [45] Market Data and Key Metrics Changes - The ADHD market has been growing at an average rate of 6% from 2019 to 2024, with stimulant medications comprising almost 90% of the market [21] - Jornay has achieved 80% coverage across its business, with 65% of its business being commercial and 35% Medicaid [25] Company Strategy and Development Direction - The company aims to drive significant growth in Jornay, maximize its pain portfolio, and strategically deploy capital to create shareholder value [16][19] - The focus is on expanding and diversifying the portfolio through business development, particularly in ADHD and neuropsychiatry [62] - The company plans to invest in increasing awareness of Jornay among healthcare professionals and patients, with a sales force expansion from 125 to 180 representatives [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position, with net leverage expected to be less than one time by the end of 2025 [53] - The company anticipates a modest decline in revenue in Q1 2025 due to typical dynamics, but expects over 10% adjusted EBITDA growth for the year [50][51] - Management highlighted the importance of disciplined capital deployment and the potential for significant growth in Jornay and the pain portfolio [19][52] Other Important Information - The company repurchased $60 million in shares during 2024, with $90 million remaining in its share repurchase program [52] - The company appointed Nancy Lurker to its Board of Directors, bringing expertise in commercial growth and strategic acquisitions [14] Q&A Session Summary Question: Path for Collegium over the next three to five years and business development opportunities - Management indicated a focus on both organic and inorganic growth, particularly in ADHD and neuropsychiatry, while maintaining a strong financial position [61][62] Question: Synergies realized from the integration of Ironshore - Management noted typical synergies achieved, but emphasized the strategic opportunity to invest in Jornay for growth [66] Question: Impact of the NO PAIN Act on the pain treatment category - Management stated that the NO PAIN Act had no impact on their portfolio, as it primarily focuses on inpatient settings [67] Question: Sales force expansion and coverage of ADHD prescribers - The expanded sales force will cover 60% of the long-acting ADHD market, targeting approximately 23,000 healthcare professionals [79] Question: Long-term planning for generic entry of Belbuca and Nucynta - Management expressed confidence that no party currently has the necessary combination of ingredients and approvals to launch competitive generics against their pain products [81][82]

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q4 2024 Earnings Conference Call February 27, 2025 4:30 PM ET Company Participants Danielle Jesse - Director, Investor Relations Vikram Karnani - President & Chief Executive Officer Scott Dreyer - Chief Commercial Officer Colleen Tupper - Chief Financial Officer Conference Call Participants Les Sulewski - Truist Securities David Amsellem - Piper Sandler Operator Greetings and welcome to the Collegium Pharmaceuticals Fourth Quarter and Full Year 2024 Earnings Conf ...

Group 1 - Collegium Pharmaceutical reported $181.95 million in revenue for Q4 2024, a year-over-year increase of 21.5% [1] - The EPS for the same period was $1.77, compared to $1.58 a year ago, representing a surprise of +14.94% over the consensus estimate of $1.54 [1] - The reported revenue exceeded the Zacks Consensus Estimate of $180.4 million by +0.86% [1] Group 2 - Total product revenues for Belbuca were $55.21 million, exceeding the average estimate of $53.96 million, with a year-over-year change of +12% [4] - Xtampza ER generated $51.45 million in revenue, surpassing the estimated $49.96 million, reflecting a +9.7% change year-over-year [4] - Symproic's revenue was $4.25 million, below the average estimate of $3.92 million, showing a year-over-year decline of -16.4% [4] - Nucynta reported $41.75 million in revenue, which was lower than the estimated $43.52 million, indicating a -13.8% year-over-year change [4] - Jornay PM achieved $29.28 million in revenue, slightly above the average estimate of $28.86 million [4] Group 3 - Collegium Pharmaceutical's shares have returned -12.6% over the past month, compared to the Zacks S&P 500 composite's -2.2% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Core Viewpoint - Collegium Pharmaceutical reported quarterly earnings of $1.77 per share, exceeding the Zacks Consensus Estimate of $1.54 per share, and showing an increase from $1.58 per share a year ago, representing an earnings surprise of 14.94% [1][2] Financial Performance - The company posted revenues of $181.95 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 0.86%, and up from $149.75 million year-over-year [2] - Over the last four quarters, Collegium has exceeded consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Performance and Outlook - Collegium Pharmaceutical shares have declined approximately 1.1% since the beginning of the year, while the S&P 500 has gained 1.3% [3] - The company's current consensus EPS estimate for the upcoming quarter is $1.46 on revenues of $176.91 million, and for the current fiscal year, it is $6.53 on revenues of $740.16 million [7] Industry Context - The Medical - Drugs industry, to which Collegium belongs, is currently ranked in the top 50% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Durect, is expected to report a quarterly loss of $0.02 per share, with revenues projected to be $6.91 million, reflecting a significant year-over-year increase [9]

Acquisition and Product Portfolio - The company acquired Ironshore on September 3, 2024, expanding its portfolio to include Jornay PM for ADHD treatment[19] - Jornay is the only FDA-approved stimulant medication for ADHD that is dosed in the evening, approved in August 2018[20] - Nucynta IR received New Patient Population exclusivity extending U.S. exclusivity from June 27, 2025, to July 3, 2026, with pediatric exclusivity granted until January 3, 2027[27] Opioid Market and Pain Management - In 2024, approximately 136.3 million opioid prescriptions were written in the U.S., a 2.5% decline from 2023 levels[36] - The overall prevalence of chronic pain among U.S. adults is 24.3%, with 8.5% suffering from high-impact chronic pain[33] - The estimated annual costs of chronic pain in the U.S. exceed $560 billion, surpassing costs for heart disease, cancer, and diabetes[34] Abuse Deterrence and Regulatory Compliance - Xtampza ER has maintained low rates of abuse compared to other Schedule II opioids since its market introduction[26] - The FDA encourages the development of abuse-deterrent formulations, which include the DETERx platform used in Xtampza ER[43] - The company is committed to ongoing monitoring of real-world abuse and diversion data through sources like RADARS and Inflexxion[24] Sales and Marketing Strategy - The pain sales force consists of approximately 105 representatives targeting 10,000 healthcare professionals, while the ADHD sales force has around 150 representatives, expected to expand to 180 by H1 2025[54] - The marketing strategy focuses on increasing awareness of product features and educating clinicians on the risks associated with prescription opioids and stimulants[55] Intellectual Property and Patent Protection - The company holds twelve issued patents for Xtampza ER in the U.S., with expiration dates projected between 2025 and 2036[57] - Nucynta IR is protected by one issued patent expiring in 2025, while Nucynta ER has three issued patents expiring between 2025 and 2029[58] - The ability to maintain patent protection is crucial, as non-compliance with patent office requirements could lead to loss of rights[199] Regulatory Environment and Compliance - The FDA aims to act on most original NDAs within six months or ten months of the application filing date, depending on the drug's nature and review priority[80] - The FDA requires a REMS to manage serious risks associated with a drug product, which can materially affect the drug's market and profitability[84] - The company must comply with various state and federal regulations regarding the manufacture and distribution of controlled substances, increasing operational costs[207] Financial Condition and Market Risks - The company has substantial outstanding indebtedness, with $629.7 million in principal outstanding under the 2024 Term Loan and $241.5 million in 2.875% convertible senior notes due in 2029[168] - The company’s ability to maintain profitability is dependent on successfully commercializing its products and any future acquisitions[161] - The company faces risks related to opioid product market acceptance, regulatory changes, and competition from generic products[164] Employee and Corporate Governance - As of December 31, 2024, the company had a total of 357 full-time employees, emphasizing the importance of human capital in achieving future success[151] - The company prioritizes employee engagement and development through transparent communication and performance review processes[149] - The company is committed to ESG initiatives, focusing on corporate governance, employee development, and community support[141] Pricing and Reimbursement Challenges - The pharmaceutical industry is facing significant pricing pressures due to managed healthcare trends and legislative proposals, which could adversely affect operations and business[128] - The Inflation Reduction Act of 2022 introduces drug price negotiation requirements and rebate payment obligations, potentially reducing profitability and financial condition[139] - Pricing regulations and third-party reimbursement policies may significantly affect the company's ability to recoup investments in its products[217] Product Commercialization and Market Acceptance - The company's success is heavily dependent on the commercialization of products such as Jornay, Belbuca, Xtampza, and Nucynta Products[176] - Successful commercialization relies on manufacturing capabilities, effective sales and marketing strategies, and educating stakeholders about product benefits[177] - The acceptance and use of the company's products depend on perceptions of safety, efficacy, and the availability of competitive products[203]

Financial Performance - Generated record quarterly net revenue of $181.9 million for Q4 2024, representing a 22% increase year-over-year[7] - Achieved pro forma full-year net revenue of $631.4 million for FY 2024, an 11% increase compared to FY 2023[8] - Reported quarterly Jornay PM® net revenue of $29.3 million, with pro forma full-year net revenue expected to exceed $135 million in 2025[3] - Adjusted EBITDA for Q4 2024 was $107.7 million, a 3% increase year-over-year, and $401.2 million for FY 2024, representing a 9% increase[8] - Product revenues for Q4 2024 reached $181.949 million, a 21.5% increase from $149.745 million in Q4 2023[25] - Net income for the year ended December 31, 2024, was $69.190 million, compared to $48.155 million in 2023, reflecting a 43.8% increase[25] - Adjusted EBITDA for the year ended December 31, 2024, was $401.190 million, up from $366.969 million in 2023, representing a 9.3% growth[27] Cash and Assets - Ended 2024 with cash, cash equivalents, and marketable securities of $162.8 million, down from $310.5 million at the end of 2023[7] - Cash and cash equivalents decreased to $70.565 million in 2024 from $238.947 million in 2023[23] - Total assets as of December 31, 2024, amounted to $1.664 billion, an increase from $1.143 billion in 2023[23] - Collegium Pharmaceutical's intangible assets increased to $891.402 million in 2024 from $421.708 million in 2023, indicating significant investment in intellectual property[23] Expenses - GAAP operating expenses for FY 2024 were $207.4 million, a 30% increase year-over-year[8] - Selling, general and administrative expenses for Q4 2024 were $63.091 million, significantly higher than $32.942 million in Q4 2023[25] - Non-cash interest expense increased to $4,664 million in Q4 2024 from $1,963 million in Q4 2023, reflecting a substantial rise of 138.5%[32] - Amortization expenses rose to $55,471 million in Q4 2024, compared to $34,514 million in Q4 2023, marking a 60.7% increase[32] - The company incurred acquisition-related expenses of $4,443 million in Q4 2024, with no such expenses reported in Q4 2023[32] Shareholder Returns - Completed $60.0 million in share repurchases during 2024, including $25.0 million in Q4[3] Guidance and Future Outlook - Reaffirmed full-year 2025 guidance for product revenues between $735.0 million and $750.0 million[4] - The company anticipates continued growth in product revenue and adjusted operating expenses for the full year 2025[20] - The company plans to focus on market expansion and product commercialization to enhance future revenue streams[20] Earnings and Income - GAAP net income for Q4 2024 was $12.5 million, with diluted earnings per share of $0.36, compared to $31.9 million in Q4 2023[7] - GAAP net income for Q4 2024 was $12,536 million, a decrease of 60.8% from $31,940 million in Q4 2023[32] - Non-GAAP adjusted net income for Q4 2024 was $68,519 million, an increase of 6.3% from $64,167 million in Q4 2023[32] - Adjusted earnings per share for Q4 2024 was $1.77, up from $1.58 in Q4 2023, representing a 12.1% increase[32] - Total adjustments for Q4 2024 amounted to $55,983 million, compared to $32,227 million in Q4 2023, indicating a significant rise in adjustments[32] - The effective tax rate for non-GAAP adjusted net income was 23.5% for Q4 2024, down from 25.9% in Q4 2023[32] Prescription Growth - Grew Jornay PM prescriptions by 29% year-over-year and 11% quarter-over-quarter in Q4 2024[3]