• Total Net Product Revenues: $159.3 million, up 17% year-over-year.
• Pain Portfolio Revenue: $151.3 million, up 11% year-over-year.
• Belbuca Revenue: $53.2 million, up 17% year-over-year.
• Xtampza ER Revenue: $49.5 million, up 24% year-over-year.
• Nucynta Franchise Revenue: $45.1 million, down 5% year-over-year.
• Jornay PM Revenue: $8 million for less than one month of sales.
• Adjusted EBITDA: $105.1 million, up 18% year-over-year.
• GAAP Net Income: $9.3 million, down 55% year-over-year.
• Non-GAAP Adjusted Earnings Per Share: $1.61, up 20% year-over-year.
• Cash, Cash Equivalents, and Marketable Securities: $120 million as of September 30, 2024.

• Warning! GuruFocus has detected 4 Warning Sign with COLL.

Release Date: November 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Collegium Pharmaceutical Inc (NASDAQ:COLL) reported a record financial performance in the third quarter of 2024, with total net product revenues reaching $159.3 million, up 17% year-over-year.
• The acquisition of Ironshore Therapeutics and its commercial product, Jornay PM, is expected to generate net revenue in excess of $100 million in 2024, expanding COLL's presence in the ADHD market.
• The pain portfolio delivered strong performance with record revenue of $151.3 million, up 11% year-over-year, driven by products like Belbuca and Xtampza ER.
• The company achieved new payer wins for Belbuca and Xtampza ER, which are expected to support revenue growth in 2025.
• Collegium Pharmaceutical Inc (NASDAQ:COLL) successfully completed its CEO search, appointing Vikram Karnani, who brings over 15 years of experience in the biopharm industry, to lead the company into its next phase of growth.

Negative Points

• The integration of Ironshore and its product Jornay PM may present challenges, as the company focuses on maximizing growth and ensuring a smooth transition.
• GAAP operating expenses increased by 76% year-over-year to $62 million, partly due to $19.9 million in acquisition-related expenses associated with the Ironshore acquisition.
• The Nucynta franchise experienced a 5% year-over-year decline in net revenue, indicating potential challenges in maintaining its market position.
• Changes in formulary coverage for Xtampza ER and Belbuca, including removal from a Medicare Part D plan, may pressure prescriptions in 2025, although expected to be net revenue positive.
• The ADHD market is highly competitive and genericized, which may pose challenges for Jornay PM despite its unique evening dosing feature.

Q & A Highlights

Q: Given Vikram's strong rare disease background, would you expect any divergence in business development plans into new therapeutic areas? A: Michael Heffernan, Interim President and CEO, stated that the focus remains on integrating Jornay PM and maximizing the pain portfolio. Business development efforts will continue to identify assets that build expertise in new therapeutic areas beyond pain. Vikram Karnani will work with the leadership team and Board to further develop Collegium's strategy.

Q: What are the plans for Belbuca and your investment efforts leading into loss of exclusivity (LOE)? A: Scott Dreyer, Chief Commercial Officer, emphasized that Collegium is investing fully in Belbuca, not in harvest mode, and sees potential upside in LOE assumptions. Belbuca is differentiated in the growing buprenorphine market for pain management.

Q: Can you discuss the back-to-school season impact on Jornay PM and its peak sales potential? A: Scott Dreyer noted that the back-to-school season is critical for ADHD products, with Jornay PM prescriptions growing 31.2% year-over-year. While peak sales figures were not disclosed, the growth trajectory is strong, and the product is expected to continue its momentum into 2025.

Q: How are you thinking about the gross to net spread for Jornay PM going forward? A: Colleen Tupper, CFO, mentioned that Jornay PM's gross to net is typical for branded ADHD products, sitting in the 60s range, with rebates and co-pay programs being significant components.

Q: How does the diverse call audience for Jornay PM inform future business development and M&A? A: Michael Heffernan highlighted that Jornay PM's call points provide flexibility for business development in various directions. The focus will be on leveraging commercial expertise and exploring new opportunities as Vikram Karnani joins and assesses future strategies.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.