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]

Core Insights - Collegium Pharmaceutical, Inc. reported record quarterly and full-year net revenue of $181.9 million and $631.4 million respectively for the year ended December 31, 2024, marking an 11% increase year-over-year [1][10] - The company achieved a quarterly GAAP net income of $12.5 million and a full-year GAAP net income of $69.2 million, with adjusted EBITDA reaching $107.7 million for the quarter and $401.2 million for the year [1][10] - Collegium ended 2024 with cash, cash equivalents, and marketable securities totaling $162.8 million and repurchased $60 million in shares during the year [1][10] Financial Performance - For the quarter ended December 31, 2024, product revenues, net were $181.9 million, a 22% increase from $149.7 million in the same quarter of 2023 [10] - GAAP operating expenses for the quarter were $60.2 million, an 83% increase from $32.9 million in the prior year [10] - Adjusted operating expenses for the quarter were $51.1 million, up 97% from $25.9 million year-over-year [10] Business Highlights - The company grew total revenue by 11% and adjusted EBITDA by 9% in 2024, while also completing an acquisition and executing $60 million in share repurchases [3][5] - Jornay PM prescriptions grew by 29% year-over-year and 11% quarter-over-quarter, with pro forma net revenue expected to exceed $135 million in 2025 [5][10] - Belbuca total prescriptions increased by 5.6% year-over-year, with net revenue reaching a record $55.2 million for the quarter, up 12% year-over-year [5][10] Strategic Outlook - The company reaffirmed its full-year 2025 guidance for product revenues, net between $735 million and $750 million, and adjusted EBITDA between $435 million and $450 million [5][10] - Collegium aims to maximize its pain portfolio and strategically deploy capital to create long-term value for shareholders [3][5] - The appointment of Nancy S. Lurker to the Board of Directors is expected to enhance the company's strategic direction [5]

Core Viewpoint - Analysts project that Collegium Pharmaceutical (COLL) will report quarterly earnings of $1.54 per share, a decline of 2.5% year over year, with revenues expected to reach $180.4 million, an increase of 20.5% from the same quarter last year [1]. Earnings Estimates - Over the past 30 days, the consensus EPS estimate has been adjusted downward by 2.9%, indicating a reassessment by covering analysts [2]. - Changes in earnings estimates are crucial for predicting investor reactions to the stock, as empirical research shows a strong correlation between earnings estimate revisions and short-term stock price performance [3]. Key Metrics Projections - Analysts estimate 'Total product revenues- Belbuca' at $53.96 million, reflecting a year-over-year increase of 9.4% [5]. - 'Total product revenues- Xtampza ER' is forecasted to reach $49.96 million, indicating a 6.5% year-over-year increase [5]. - The consensus estimate for 'Total product revenues- Symproic' is $3.92 million, showing a decline of 22.9% from the prior-year quarter [5]. - 'Total product revenues- Nucynta' is estimated at $43.52 million, representing a decrease of 10.2% from the year-ago quarter [6]. Stock Performance - Shares of Collegium Pharmaceutical have returned -12% over the past month, compared to a -2.3% change in the Zacks S&P 500 composite [6]. - With a Zacks Rank 3 (Hold), COLL is expected to mirror overall market performance in the near future [6].

Group 1 - Collegium Pharmaceutical, Inc. will report its fourth quarter and full-year 2024 financial results on February 27, 2025, after market close [1] - A live conference call and webcast will follow the financial results release at 4:30 p.m. ET [1] - The conference call can be accessed via specific dial-in numbers for U.S. and international participants [2] Group 2 - Collegium is focused on building a diversified biopharmaceutical company with a strong portfolio in pain management and a recent acquisition in neuropsychiatry [3] - The company aims to grow its commercial portfolio, with Jornay PM identified as the lead growth driver [3] - Collegium is committed to disciplined capital deployment to support its strategic initiatives [3]

Core Viewpoint - Collegium Pharmaceutical, Inc. has appointed Nancy S. Lurker to its Board of Directors, effective February 4, 2025, which is expected to enhance the company's strategic growth and commercial capabilities [1][2]. Company Overview - Collegium Pharmaceutical is focused on building a diversified biopharmaceutical company aimed at improving the lives of individuals with serious medical conditions [5]. - The company has a strong portfolio in responsible pain management medications and has recently expanded into the neuropsychiatry market with the acquisition of Jornay PM, a treatment for ADHD [5]. Leadership and Expertise - Nancy S. Lurker brings extensive experience in commercial growth and strategic acquisitions, having previously served as President and CEO of EyePoint Pharmaceuticals and held leadership roles at PDI, Inc. and Novartis Pharmaceuticals [2][3]. - Lurker's appointment is seen as pivotal for Collegium as it enters a new growth phase [2]. Board and Advisory Roles - In addition to her role at Collegium, Lurker serves on the boards of Alkermes plc and Altasciences, LLC, and is involved with advisory boards for Novo Holdings and Stanford Medicine [3]. - Her previous board positions include notable companies such as Cancer Treatment Centers of America and Mallinckrodt Pharmaceuticals [3]. Educational Background - Lurker holds a B.S. in Biology from Seattle Pacific University and an M.B.A. from the University of Evansville [4].

Core Insights - Collegium Pharmaceutical, Inc. has announced its financial guidance for 2025, projecting product revenues between $735 million and $750 million, with adjusted EBITDA expected to be in the range of $435 million to $450 million, and adjusted operating expenses anticipated between $220 million and $230 million [1][6][4] Financial Guidance for 2025 - The company expects Jornay PM net revenue to exceed $135 million in 2025, driven by its strategic focus on commercial expansion and targeted investments in the product [2][6] - Adjusted EBITDA is projected to be between $435 million and $450 million, while adjusted operating expenses are expected to range from $220 million to $230 million [1][6] Recent Business Highlights - Collegium completed the integration of Ironshore Therapeutics and saw an increase in average weekly prescriptions for Jornay PM during the 2024 back-to-school season [6] - The company repurchased $60 million in shares as part of its $150 million share repurchase program [6] Company Strategy - Collegium aims to build a diversified biopharmaceutical company focused on improving the lives of individuals with serious medical conditions, with a leading portfolio in pain management and a new presence in neuropsychiatry through Jornay PM [5][2] - The company is committed to disciplined capital deployment to create long-term shareholder value while maximizing performance across its entire portfolio [2][5]

Core Insights - The Zacks Rank system focuses on earnings estimates and revisions to identify winning stocks, while also considering trends in value, growth, and momentum [1] - Value investing aims to find undervalued companies through fundamental analysis and traditional valuation metrics [2] Company Analysis: Collegium Pharmaceutical (COLL) - COLL holds a Zacks Rank of 2 (Buy) and a Value grade of A, indicating strong interest from investors [3] - The P/S ratio for COLL is 1.69, significantly lower than the industry average of 3.29, suggesting it is undervalued [4] - COLL's P/CF ratio is 5.51, compared to the industry's average of 10.45, indicating a solid cash outlook [5] - Over the past 12 months, COLL's P/CF has fluctuated between 5.26 and 8.61, with a median of 6.44 [5] Company Analysis: Jazz Pharmaceuticals (JAZZ) - JAZZ also has a Zacks Rank of 2 (Buy) and a Value Score of A, making it another attractive option for investors [6] - The forward P/E for JAZZ is 5.87, significantly lower than the industry average of 58.22, and its PEG ratio is 0.84 compared to the industry average of 2.36 [6] - JAZZ's Forward P/E has ranged from 4.97 to 6.87, with a median of 5.62, while its PEG ratio has varied between 0.64 and 1.44, with a median of 1.07 [7] - The P/B ratio for JAZZ is 1.88, slightly above the industry's average of 1.35, with a 52-week range of 1.59 to 2.27 and a median of 1.89 [7] Conclusion - Both COLL and JAZZ exhibit strong value metrics, suggesting they are likely undervalued and present impressive investment opportunities based on their earnings outlook [8]

Investors in Collegium Pharmaceutical, Inc. (COLL) need to pay close attention to the stock based on moves in the options market lately. That is because the Dec 20, 2024 $20 Put had some of the highest implied volatility of all equity options today.What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It ...

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET Company Participants Danielle Jesse - Director, Investor Relations Michael Heffernan - Interim President and Chief Executive Officer, Founder and Chairman Scott Dreyer - Chief Commercial Officer Colleen Tupper - Chief Financial Officer Conference Call Participants Les Sulewski - Truist Securities David Amsellem - Piper Sandler Serge Belanger - Needham & Company Oren Livnat - H.C. Wainright Operator Gree ...