Collegium Pharmaceutical (COLL) Cuộc họp công bố kết quả kinh doanh Q3 2026: Tăng trưởng mảng ADHD thúc đẩy doanh thu kỷ lục

Điểm nhấn chính

• Collegium Pharmaceutical công bố doanh thu thuần từ sản phẩm đạt mức kỷ lục 216,3 triệu USD trong quý 3/2026, tăng 3% so với cùng kỳ năm trước, nhờ đà tăng trưởng của mảng thuốc điều trị ADHD bù đắp cho áp lực sụt giảm trên danh mục thuốc giảm đau.
• Các sản phẩm điều trị ADHD đóng góp hơn 36% tổng doanh thu. Doanh thu của Jornay PM tăng 24% lên 51,9 triệu USD, trong khi Azstarys mang về 26,5 triệu USD trong quý trọn vẹn đầu tiên thuộc quyền sở hữu của Collegium.
• Số lượng đơn thuốc Jornay PM tăng 16% so với cùng kỳ năm trước. Gần 33.000 chuyên gia y tế đã kê đơn sản phẩm này, tăng 19%, trong khi thị phần của thuốc trên thị trường methylphenidate tác dụng kéo dài có thương hiệu đạt khoảng 30%.
• Thu nhập thuần theo GAAP giảm từ 31,5 triệu USD xuống 21,8 triệu USD. EBITDA điều chỉnh giảm 9% xuống 121,6 triệu USD do chi phí hoạt động điều chỉnh tăng 25%.
• Ban lãnh đạo tái khẳng định dự báo năm 2026 với tổng doanh thu sản phẩm từ 825 triệu USD đến 855 triệu USD và EBITDA điều chỉnh từ 445 triệu USD đến 470 triệu USD.
• Danh mục thuốc giảm đau mang lại 138 triệu USD doanh thu trong quý, nhưng doanh thu từ dòng sản phẩm Nucynta giảm 44% do cạnh tranh từ thuốc generic và doanh thu Xtampza ER giảm 9% do áp lực từ các bên chi trả bảo hiểm.

Dữ liệu tài chính quan trọng

Hiệu quả kinh doanh và hoạt động

Jornay PM tiếp tục là động lực tăng trưởng chính. Số lượng đơn thuốc tăng 16% so với cùng kỳ năm trước, trong đó tăng trưởng ở bệnh nhân nhi và thanh thiếu niên là 13%, và ở người trưởng thành là 27%. Bệnh nhân nhi và thanh thiếu niên chiếm khoảng 80% số đơn thuốc Jornay PM. Số đơn thuốc cho bệnh nhân mới dùng sản phẩm lần đầu tăng 22% trong tháng 9, và ban lãnh đạo cho biết đà tăng trưởng này vẫn tiếp diễn trong tháng 10.

Số lượng đơn thuốc Azstarys tăng gần 2% so với cùng kỳ năm trước sau khi giảm gần 2% trong năm 2025. Collegium đã mở rộng đội ngũ bán hàng mảng ADHD lên khoảng 190 đại diện và tăng tệp chuyên gia y tế mục tiêu lên khoảng 27.000 người, so với mức 21.000 người trước đợt mở rộng năm 2025. Ban lãnh đạo kỳ vọng việc tiếp cận sâu rộng hơn với bác sĩ cùng các hoạt động tiếp thị mới tới bệnh nhân và người chăm sóc sẽ hỗ trợ Azstarys tăng trưởng nhanh hơn theo thời gian.

Tổng cộng, Jornay PM và Azstarys nắm giữ khoảng 55% thị phần methylphenidate tác dụng kéo dài có thương hiệu. Ban lãnh đạo nhấn mạnh đặc tính bổ trợ lẫn nhau của hai sản phẩm: Jornay PM được dùng vào ban đêm để kiểm soát triệu chứng ngay khi thức dậy, trong khi Azstarys kết hợp cả dược chất tác dụng nhanh và tác dụng kéo dài trong một viên nang.

Danh mục thuốc giảm đau vẫn là nguồn tạo tiền mặt quan trọng. Doanh thu của Belbuca nhìn chung ổn định cả so với cùng kỳ năm trước lẫn so với quý trước. Số lượng đơn thuốc Xtampza ER tăng khoảng 3% so với quý 2 dù doanh thu giảm, và ban lãnh đạo dự kiến lượng đơn thuốc sẽ duy trì ở mức tương đương trong thời gian còn lại của năm 2026. Một bên chi trả bảo hiểm lớn chi trả cho khoảng 15 triệu người dự kiến sẽ đưa Xtampza ER vào danh mục thuốc được chi trả độc quyền từ ngày 1 tháng 1 năm 2027.

Collegium đã bắt đầu chương trình mua lại cổ phiếu cấp tốc trị giá 50 triệu USD trong quý 3 và dự kiến hoàn tất trước cuối năm. Công ty còn 100 triệu USD trong hạn mức mua lại cổ phiếu được phê duyệt vào tháng 7. Tỷ lệ nợ thuần trên EBITDA điều chỉnh đạt khoảng 2 lần vào cuối quý.

Dự báo của ban lãnh đạo

Collegium tái khẳng định dự báo cho cả năm 2026:

Ban lãnh đạo cho biết việc phân bổ vốn sẽ tiếp tục cân đối giữa phát triển kinh doanh, trả nợ và mang lại lợi nhuận cho cổ đông khi có cơ hội thuận lợi.

Rủi ro và các yếu tố cần theo dõi

• Nucynta tiếp tục đối mặt với sự cạnh tranh từ thuốc generic, nguyên nhân khiến doanh thu trong quý 3 giảm 44% so với cùng kỳ năm trước.
• Xtampza ER tiếp tục chịu áp lực từ các bên chi trả bảo hiểm trên toàn thị trường opioid tác dụng kéo dài có thương hiệu.
• Teva có khả năng sẽ ra mắt phiên bản generic của Belbuca sau ngày thỏa thuận giải quyết 23 tháng 1 năm 2027. Ban lãnh đạo nhận định rủi ro trong ngắn hạn là hạn chế và cho biết chưa ghi nhận việc FDA phê duyệt, công bố giá hay hoạt động nào từ các bên bán buôn cho thấy một đợt ra mắt sắp diễn ra.
• Chi phí đầu tư thương mại cao hơn đã góp phần khiến chi phí hoạt động theo GAAP tăng 44% và chi phí hoạt động điều chỉnh tăng 25%.
• Các sáng kiến tăng trưởng cho Azstarys có thể cần thời gian để tác động đến số lượng đơn thuốc. Ban lãnh đạo không đưa ra mục tiêu tăng trưởng cụ thể cho năm 2027.

Điểm nhấn phiên hỏi đáp với chuyên gia phân tích

Tăng trưởng và tỷ lệ gross-to-net của Azstarys: Ban lãnh đạo kỳ vọng mức tăng trưởng số lượng đơn thuốc sẽ tăng tốc khi Collegium mở rộng tiếp cận bác sĩ và triển khai tiếp thị kỹ thuật số tới bệnh nhân và người chăm sóc. Tỷ lệ gross-to-net của Azstarys đạt 73,4% trong quý 3 so với 74,1% trong quý 2. Công ty nhận thấy vẫn còn dư địa để cải thiện dần nhưng không đặt ra mục tiêu cụ thể.

Sự trùng lặp trong danh mục thuốc điều trị ADHD: Ban lãnh đạo cho biết các bác sĩ đã phản hồi tích cực khi cùng một đại diện bán hàng giới thiệu cả Jornay PM và Azstarys. Hai sản phẩm này hướng đến các nhu cầu khác nhau của bệnh nhân, đồng thời cho phép Collegium thúc đẩy hoạt động kê đơn sâu hơn trong cùng một tệp chuyên gia y tế.

Yếu tố mùa vụ: Nhu cầu trong mùa tựu trường đóng vai trò quan trọng đối với cả hai thương hiệu. Khoảng 80% doanh thu của Jornay PM và hai phần ba doanh thu của Azstarys đến từ bệnh nhân nhi, mặc dù Azstarys có tỷ trọng bệnh nhân là người trưởng thành cao hơn.

Rủi ro thuốc generic đối với Belbuca: Collegium chưa ghi nhận các tín hiệu về mặt pháp lý, định giá hay phân phối mà ban lãnh đạo kỳ vọng sẽ xuất hiện trước một đợt ra mắt thuốc generic. Công ty có kế hoạch tiếp tục đầu tư vào Belbuca đồng thời theo dõi sát sao diễn biến tình hình.

Phát triển kinh doanh: Ban lãnh đạo cho biết chiến lược của công ty vẫn tập trung vào việc mua lại, tích hợp và phát triển các tài sản mang tính khác biệt. Công ty vẫn cởi mở với những cơ hội rộng mở hơn nhưng chưa xác định một giao dịch mang tính chuyển đổi cụ thể nào.

Toàn văn biên bản cuộc họp công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Greetings, and welcome to the Collegium Pharmaceutical third quarter 2026 earnings conference call. [Operator Instructions] Please note that this conference call is being recorded. I will now turn the call over to Ian Karp, Head of Investor Relations. Thank you. You may begin.

Ian Karp

Great, thanks, Maria, and welcome to Collegium Pharmaceutical's third quarter 2026 earnings conference call. I'm joined today by Vikram Karnani, our President and Chief Executive Officer, and Colleen Tupper, our Chief Financial Officer.

Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional, and that any statements made today are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties as detailed in the company's periodic reports filed with the Securities and Exchange Commission. Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on our corporate website. And with that, I'll now turn the call over to our President and CEO, Vikram Karnani.

Vikram Karnani

Thank you, Ian. Good morning, everyone, and thank you for joining our third quarter 2026 earnings call. Collegium is a dynamic commercial-stage biopharmaceutical company focused on improving the lives of people living with serious and often misunderstood conditions. Our success is built upon our proven ability to acquire, integrate, and grow differentiated medicines while creating long-term shareholder value. This strategy has established a portfolio of 6 differentiated medicines, reflecting the significant evolution our company has undertaken over the past several years. ADHD has become our lead growth driver, accounting for more than 36% of total revenue, up from just 19% last year. With Jornay PM and Azstarys, we have 2 complementary medicines supported by an expanding commercial platform to drive future growth. Meanwhile, our pain portfolio continues to generate robust cash flows, providing the financial flexibility to invest in our ADHD portfolio and further diversify our business.

The team at Collegium remains focused, invigorated, and committed to making a meaningful difference in the lives of patients and creating long-term value for our shareholders. We delivered record quarterly net revenue of $216.3 million, up 3% year-over-year, driven by growth in ADHD during the important back-to-school season. Key achievements this quarter included: Jornay PM prescriptions grew by 16%, generating a record $51.9 million in net revenue, up 24% year-over-year. Jornay PM prescribers also reached another all-time high with nearly 33,000 healthcare providers writing Jornay PM prescriptions in the quarter, up 19% over Q3 of last year. Our investments in Jornay PM are translating into broader prescriber adoption and continued prescription growth. Azstarys generated $26.5 million in net revenue during its first full quarter under our ownership. Prescriptions grew nearly 2% year-over-year, following a decline in 2025.

This is an early indication of the opportunity to grow Azstarys through our expanded ADHD commercial platform. Our pain portfolio generated $138 million in revenue during the quarter, continuing to make a meaningful contribution to our business. Performance was in line with our expectations and consistent with our 2026 full-year financial guidance. Turning now to other recent corporate updates. We are continuously seeking ways to support the ADHD patient community and in October, which was ADHD Awareness Month, we announced 2 new initiatives. First, we launched Start Talking ADHD, our online resource hub offering practical guides to people living with ADHD and their caregivers. Next, we established a new multi-year partnership with Boston Legacy FC, Boston's professional women's soccer club, focused on promoting inclusion and accessibility through youth coach training, an annual Sports for All Summit, and sensory inclusion programs designed to support neurodivergent children and their families, including those living with ADHD.

We also further advanced our capital allocation strategy by returning capital to shareholders through a $50 million accelerated share repurchase program announced in the third quarter. We expect to complete the full repurchase amount before the end of the year and have $100 million remaining on our share repurchase program that was authorized by our Board last July. As we look toward the end of 2026 and move into next year, we remain focused on 3 key strategic priorities: growing our ADHD business, maximizing the value of our pain portfolio, and strategically deploying capital to create long-term shareholder value. Our ADHD portfolio performed particularly well in the third quarter, further supported by our promotional activities, expanded sales force, and the back-to-school season. The momentum across our ADHD business has enabled us to reaffirm our full-year 2026 guidance, which includes $190 to $200 million in Jornay PM revenues, a 31% increase year-over-year at the midpoint, and $65 to $75 million in partial-year Azstarys revenues. In pain, our focus is on maximizing portfolio value and cash generation. That cash flow supports investment in ADHD and provides flexibility to pursue business development, repay debt, and return capital to shareholders.

Turning to our leadership position in ADHD, we now have a unified commercial organization focused on accelerating growth and maximizing operational leverage. And at the foundation of this franchise are Jornay PM and Azstarys, 2 differentiated and complementary medicines that serve different patient types, allowing us to address the unmet needs of a wide range of patients. Both medicines can last all day and offer a smooth offset, helping to avoid a treatment crash, which can be seen with other ADHD medicines. The main differences between Jornay PM and Azstarys are in the timing of their symptom control. Jornay PM is the first and only stimulant dosed at night, delivering symptom control without delay upon awakening. Jornay PM is often preferred by the patient whose symptoms are particularly challenging first thing in the morning and who needs their all-day symptom control to start immediately upon awakening. Azstarys is the first and only ADHD stimulant treatment with both fast- and long-acting medicines in 1 capsule, delivering rapid, all-day symptom control. Azstarys is often preferred by the patient who has more variability in their daily schedule and needs the flexibility of rapid-onset symptom control and efficacy to last long into the evening.

In fact, driven by our targeted investments and enhanced commercial efforts, HCP perceptions of Jornay PM are increasingly positive. Based on market research completed earlier this year, HCPs had a high favorability rating and ranked Jornay PM as the #1 branded ADHD medicine in terms of product differentiation with a score significantly higher than all other medicines in the same category. The same market research conducted prior to Collegium's acquisition of Azstarys also yielded important insights into Azstarys's market opportunity. Namely, it was viewed as meaningfully differentiated in the ADHD treatment landscape, and more than half of physicians surveyed indicated an intent to increase prescribing in the future. We believe there is a significant opportunity to increase HCP perception of Azstarys in the months and quarters ahead by utilizing our enhanced ADHD commercial platform. And encouragingly, Collegium ranked #1 in reputation among pharmaceutical companies specializing in ADHD. Combined, Jornay PM and Azstarys now command approximately 55% share of the total branded long-acting methylphenidate market.

With the majority of the long-acting methylphenidate market comprised of generics, we believe there remains a significant opportunity to capture additional share, particularly among patients who are dissatisfied with their current generic treatment. This quarter, Jornay PM remained the fastest-growing stimulant for the treatment of ADHD and demonstrated strong performance across a number of key metrics. Prescriptions grew 16% year-over-year. Prescribers hit an all-time high with nearly 33,000 healthcare providers writing Jornay PM prescriptions, up 19% year-over-year. Jornay PM's share in the branded long-acting methylphenidate market also hit an all-time high at approximately 30%, up 6.5 percentage points year-over-year. We also saw solid growth across both the pediatric and adult segments. In the pediatric and adolescent segment, which represents about 80% of our business, prescriptions grew 13% year-over-year. Growth was even stronger in the adult segment, representing about 20% of our overall prescriptions, which grew 27% year-over-year.

New-to-brand prescriptions provided another measure of potentially accelerating demand, capturing patients who were new to Jornay PM or have not received a prescription in the prior 12 months. In September, the first full month of the back-to-school season, new-to-brand prescriptions grew 22% year-over-year, and that momentum has accelerated in October. Bolstered by the back-to-school season, Jornay PM delivered particularly strong performance this quarter, and our priority is to sustain prescription growth throughout the remainder of the year. This was also our first full quarter promoting Azstarys, and we are just beginning to see the benefits of having 2 differentiated and complementary ADHD medicines in our portfolio. In addition, prior to our acquisition of Azstarys, commercial investment in the product was limited and at times inconsistent. This likely contributed to Azstarys's total prescriptions declining by nearly 2% in 2025. Despite these declining volumes, market research suggested that Azstarys was the second most differentiated stimulant brand following Jornay PM.

With its strong brand fundamentals, coupled with our commercial expertise and track record of growing acquired products, we believe that we can maximize Azstarys's growth potential in the years ahead. And we have already started to see early signs of success with prescriptions up nearly 2% year-over-year in the third quarter, following an annual prescription decline in 2025. Importantly, Azstarys has IP protection through 2037, extending the life cycle of our commercial portfolio and giving us additional time to maximize the reach and full value of Azstarys. Following the close of the Azstarys acquisition in May, we were able to rapidly and seamlessly integrate Azstarys into our commercial infrastructure. We have made targeted investments, expanding our ADHD commercial team and marketing capabilities. We grew our ADHD sales force to about 190 reps, up from 180 prior to the acquisition, and our target HCPs to about 27,000, up from 21,000 pre-expansion in 2025. We also recently expanded our medical affairs team to better support both products from a clinical standpoint.

All of our sales representatives were fully trained and selling both products to their targeted HCPs in July ahead of the back-to-school season to maximize impact. We are now deploying our targeted HCP, patient, and caregiver marketing efforts for both Jornay PM and Azstarys. Early initiatives include focused AI-targeted digital marketing campaigns, peer-to-peer programming, and increasingly shifting investment towards awareness-driving brand campaigns built on each product's clinical strengths. Turning to our responsible pain management business, this portfolio comprised of Belbuca, Xtampza ER, and Nucynta continues to provide a solid foundation for Collegium that through its strong cash generation provides financial flexibility to invest in the growth of our ADHD business, execute disciplined business development opportunities, and return capital to shareholders. Belbuca delivered solid performance again this quarter, with revenues of $57.7 million, broadly flat year-over-year and sequentially. Xtampza ER revenue declined year-over-year, reflecting continued payer pressure across the branded long-acting opioid market that accelerated at the start of this year.

Prescription levels, however, increased slightly in each sequential quarter of 2026, including approximately 3% growth in Q3 compared to Q2. Looking ahead, we expect similar prescription levels for the remainder of 2026 and are encouraged that 1 large payer, representing about 15 million covered lives, will move Xtampza ER into an exclusive formulary position on January 1, 2027. The Nucynta franchise revenue also declined year-over-year, driven largely by generic competition. Encouragingly, prescription volumes for our branded products have remained relatively consistent over the past 3 to 4 months, and pricing for the authorized generics was stable between Q2 and Q3. Our sales expectations for the remainder of the year are appropriately reflected in our full-year revenue guidance. In summary, while we are seeing some expected pressure on our legacy pain business this year, particularly due to Nucynta, we continue to expect this business to remain a durable contributor to revenue, earnings, and cash flow in the years ahead. I will now hand the call over to Colleen to discuss our financial highlights before I return with some concluding remarks.

Colleen Tupper

Thanks, Vikram. Good morning, everyone. In the third quarter, we saw significant growth in Jornay PM, strong contribution from our first full quarter of Azstarys ownership, and meaningful revenues from our pain portfolio. Financial highlights for the third quarter include: total net product revenues were $216.3 million in the quarter, up 3% year-over-year. Jornay PM net revenue was $51.9 million in the quarter, up 24% year-over-year. Azstarys net revenue was $26.5 million in its first full quarter under Collegium ownership. Belbuca net revenue was $57.7 million in the quarter, down 1% year-over-year. Xtampza ER net revenue was $45.8 million in the quarter, down 9% year-over-year. Total Nucynta franchise net revenue was $30.8 million in the quarter, down 44% year-over-year. This includes $4.2 million in revenue from the profit share on the authorized generic versions of Nucynta and Nucynta ER.

GAAP operating expenses were $96.7 million in the quarter, up 44% year-over-year. Adjusted operating expenses were $69.4 million, up 25% year-over-year. GAAP net income was $21.8 million in the quarter compared to net income of $31.5 million in Q3 2025. Non-GAAP adjusted EBITDA was $121.6 million in the quarter, down 9% year-over-year. GAAP earnings per share were $0.69 basic and $0.60 diluted in the quarter, compared to earnings of $1 basic and $0.84 diluted in the prior-year quarter. Non-GAAP adjusted earnings per share was $1.96 in the quarter compared to $2.25 in the prior-year quarter. See our press release issued earlier today for a reconciliation of GAAP to non-GAAP results.

We generated operating cash flows of $86.5 million in the third quarter, and as of September 30, 2026, we had $144.8 million in cash, cash equivalents, and marketable securities. We are reaffirming our 2026 financial guidance today. We expect Jornay PM net revenues in the range of $190 to $200 million and Azstarys net revenue in the range of $65 to $75 million. We expect total product revenues in the range of $825 to $855 million. This represents an 8% increase year-over-year at the midpoint, driven by the strong performance and rapid growth in our ADHD portfolio, partially offset by lower pain portfolio net revenue. We expect adjusted EBITDA in the range of $445 to $470 million, essentially flat compared to 2025.

Our capital allocation strategy remains focused on creating long-term value for our shareholders by executing on business development, paying down debt, and opportunistically returning capital to shareholders. We have successfully and efficiently integrated Azstarys into our portfolio and are already generating prescription growth in our first full quarter owning and promoting the product following prescription declines last year. We also returned value to shareholders through the execution of a $50 million accelerated share repurchase program, which began in Q3 and is expected to be complete before the end of the year. And due to our robust cash generation, we ended the third quarter with net debt to adjusted EBITDA of approximately 2 times. I will now turn the call back to Vikram for final remarks.

Vikram Karnani

Thank you, Colleen. Our third quarter results demonstrate the positive ongoing evolution of Collegium: record revenue, an ADHD business that now contributes more than 36% to our top line, and a pain portfolio that continues to generate cash to support our long-term strategy. We are pleased to be reaffirming our 2026 guidance today and excited by what the future holds. Our commercial capabilities and financial flexibility position us well to pursue our next phase of growth and create long-term shareholder value. We look forward to providing you with updates on our progress in the future. With that, we'll now open the call up for Q&A. Operator?

Operator

[Operator Instructions] Our first question comes from Les Sulewski with Oppenheimer. Please proceed with your question.

Unknown Speaker

Congrats on the progress, guys. Couple for me. First on Azstarys, with the first full quarter of Azstarys now behind you, what are some of the puts and takes around accelerating patient starts, and what can move prescriptions beyond the low single digits? And where does GTN now stand versus the initial 75%?

Vikram Karnani

Yes, Les, thanks for the question. Maybe I'll start with the puts and takes on Azstarys from what effort will drive prescriptions higher and then I'll have Colleen comment on gross-to-net. Look, I think when we announced the deal back earlier this year, our research indicated that Azstarys is a highly differentiated brand for ADHD. Rapid onset of action gives patients the flexibility—those patients that need flexibility in their schedule that need rapid onset of action and control well into the day, and most importantly, prevent a crash by way of providing a smooth offset. And this is a particular differentiator for Azstarys, primarily due to the prodrug component within the capsule. This is broadly recognized by physicians and our expanded commercial platform, which now consists of 190 reps, is out there making sure that there is broad awareness of Azstarys and its merits.

That has been very well received by physicians and as I said in my prepared remarks, when a rep presents a physician with both options, Jornay PM and Azstarys, it actually casts the whole portfolio in a really nice, very good light for physicians, gives them more options for their patients. Beyond that, as I also said in my prepared remarks, prior to the acquisition, Azstarys really did not have much by way of marketing campaigns or digital marketing efforts or any such initiatives. Recall, we put them in place for Jornay PM last year and we saw the results, and we expect to do the same thing with Azstarys moving forward, and that should drive growth higher into the future from a prescription standpoint.

Colleen Tupper

Maybe on the gross-to-net, Colleen. Yes, absolutely. Les, thanks for the question. So gross-to-nets for the third quarter for Azstarys were 73.4%. That compares to the figure you mentioned of 74.1% in the second quarter. I would say the slight improvement is a little bit more of timing than a specific element. We do believe there are maybe some opportunities to improve gross-to-nets, and this is something we will continue to evaluate over the coming months. Our market access strategy remains focused on balancing broad patient coverage with enhancing the profitability by managing those gross-to-nets, and we expect to continue to evaluate any potential opportunities for improvement with that strategy.

Unknown Speaker

Just to move on to Belbuca, for the access changes, how much incremental demand are you seeing from the additional 9 million covered lives and what rebate investment was required? And when should that access translate to uptake? And then just separately, would you be able to talk about January approaching, has anything changed in your assessment of a potential generic launch? Have you observed any changes in payer contracting or wholesaler purchasing? And how are you incorporating that uncertainty into 2027?

Vikram Karnani

Thanks, Les. Maybe I'll address the payer question. It's very early days, so I don't know that we can clearly point to expanded demand on Belbuca just yet. It's something that has to play out a little bit over time, so as we observe that play out, we will continue to keep you updated. I know you had another question that was specifically related to the potential of a generic launch. Maybe I'll kick that over to Scott.

Colleen Tupper

I'll try to hit, you had a couple points there, so just come back if I miss anything. But as Vikram said, early days on the payer change, no change to our guidance since our latest update. We'll look forward to providing 2027 guidance in the early days of 2027. But to step back and think about what we are monitoring here because of the potential generic entrant, first, Belbuca, as you saw, had another solid performance in the third quarter with revenues flat to the second quarter of this year. Recall the Belbuca revenues were up 10% year-over-year in Q2. In our view, Belbuca has only limited risk of near-term generic entrance, and to date we have not seen any specific signs that Teva plans to launch a generic version after January 23 of 2027, which is the settlement date.

In terms of signs of what we are monitoring, Teva would need to receive approval from the FDA and we would expect to see pricing information published in the compendia for the generic product. We would also expect to start hearing from the drug wholesalers and distributors as they typically contract in advance of a generic manufacturer launch. So to date we haven't seen any of those signals, and based on our past generic launches, we would expect to see some or all at least 1 month or even earlier before the impending launch. So we watch this very closely. As far as what our activities and actions are leading into that date, given the uncertainty, we continue to invest behind Belbuca and we will do so through that date and really take action very quickly if an event does come to bear.

Unknown Speaker

Very helpful. Thank you.

Operator

Our next question comes from Daniel Clark with Leerink Partners. Please proceed with your question.

Phần hỏi đáp

Daniel Christopher Clark

Congrats on the nice quarter here. Just wanted to ask about the ADHD franchise a little bit here. How are you thinking about at this point sort of where the overlap fits in terms of the prescribing base between Jornay PM and Azstarys? And what's the receptivity been from Jornay PM prescribers now that Azstarys is in their sales bag? And then just a quick one on gross-to-net, just curious where you think Azstarys gross-to-net can kind of trend relative to Jornay PM.

Vikram Karnani

Yes, thank you, Daniel. I'll take the first part of the question and Colleen will comment on the gross-to-net. As I said earlier, we have a single efficient sales force now selling both products and focused on activating new HCPs and increasing the depth of prescribing. Based on growing opportunities in ADHD, we increased the size of our sales force and target HCP universe twice in the last 2 years. And as I stated previously, our current sales force is about 190 representatives, promoting both Jornay PM and Azstarys, targeting about 27,000 HCPs. The early insights suggest that HCPs are more receptive to seeing a single rep promoting both brands, which helps improve the commercial efficiency and expands our reach. We also have targeted patient and caregiver outreach, particularly through social media platforms, that have successfully increased awareness and trials for Jornay PM and represents an additional opportunity across both brands.

I think maybe I'll also add another comment. Jornay PM and Azstarys are both differentiated but complementary to each other. They serve different patient types. Jornay PM is the only stimulant ADHD medication with evening dosing that provides symptom control immediately upon awakening and throughout the day. And Azstarys is the first and only ADHD treatment with both fast- and long-acting medicines in 1 capsule. And when a single representative presents both of these options to prescribers, it gives us the opportunity to serve a wide variety of patients in their practice. And that has been very well received by prescribers.

Colleen Tupper

Great. Thanks for the question on Azstarys gross-to-net. As noted, we do believe there is opportunity for improvement on the Azstarys gross-to-net. At this point, I am not willing to communicate a specific target. I will give a little bit of extra color on the contrast with Jornay PM, though, to give you a little bit more context. When we acquired Jornay PM, that first year gross-to-nets were in the low 70s, and we were able to come down to about mid-60s for the full year of 2025, and that's what we have communicated we expect for 2026. That significant step down both in quantum as well as as quick as it was was largely driven by improvements in return rates as product that had been sold into the channel through a time of demand volatility as well as short dating, as that product return rate improved, and that helped get us quickly to step down the gross-to-net. I do not expect that to repeat with Azstarys, although we are confident there are incremental changes that we will make over time. And we look forward to updating you. When I have a clearer sight to that, I will start giving some additional context.

Daniel Christopher Clark

Got it, super helpful. Thank you.

Operator

Our next question comes from Dennis Ding with Jefferies. Please proceed with your question.

Unknown Speaker

This is Noah on for Dennis. Congrats and thank you for taking our question. So our question is about business development. So we know that the business model is around growing assets, deleveraging, and repeating, but stepping back and looking across your business, have you considered a transformational type of deal, specifically around monetizing your underlying pain business, which seems to be putting pressure on your multiple?

Vikram Karnani

Thanks for the question, Noah. Look, I think when we have talked about business development previously, I just want to reiterate, our strategy remains unchanged from a business development standpoint. As we have demonstrated quite successfully over the last several years, we have a proven track record of acquiring differentiated assets, integrating them very quickly and seamlessly into the company, and then growing them. That is what we are focused on. Your question about transformational opportunities or anything like that, we are always open, we are always opportunistic, we consider every idea that comes our way, but I don't know that we can specifically comment on a particular transformational opportunity that we're looking at. So I would just go back and say that our BD strategy and approach remains consistent to what we have described before. And I would actually take it 1 step above and say our capital allocation strategy as a whole remains consistent to what we've said before. Anytime we have a significant amount of cash that we can invest, we look across the board at BD opportunities, paying down debt, and/or returning capital to our shareholders. And all 3 approaches remain a part of our priority set. Thank you.

Operator

Our next question comes from Brandon Folkes with HC Wainwright. Please proceed with your question.

Brandon Folkes

Congrats on the quarter. I'll just follow on from the prior question to start. How do you think about your absolute debt load currently, especially given the overhang of the exclusivity loss on Belbuca? In your view, what would get you to reduce some of the debt over the share buyback program? And then secondly, can you just talk about some of the pushes and pulls in the implied Q4 Jornay PM revenue guidance?

Vikram Karnani

Thanks, Brandon. Going back to your question about how we think about capital allocation and paying down debt, again, I think we remain consistent to our strategy that we have always laid out. When we have access to cash, we look across the board and look at what the debt looks like on the balance sheet, what opportunities might be out there. It's always a judgment call on where you choose to invest and drive maximum long-term value for our shareholders. And that is exactly the approach that will continue. Your second question was about pushes and pulls for gross margin in terms of the full year. We remain focused on driving prescription growth and prescriber growth, which is what we can control through the rest of the year. Just recall, the back-to-school season, which is a really important part of the year for the ADHD medicines, doesn't just start and stop in the early part of the fall. It actually continues well into the fourth quarter sometimes. We are continuing, as I said in my remarks, we saw new-to-brand Rxs were up 22% in September, and we've seen that momentum continue into October. So we're still in the middle of the back-to-school season. We expect that we will continue to drive prescription growth, expand the base of prescribers, and this is our plan for both Jornay PM and Azstarys. We'll keep you updated as we close out Q4.

Brandon Folkes

Great, thank you very much and congrats on the quarter.

Vikram Karnani

Thanks, Brandon.

Operator

Our next question comes from Serge Belanger with Needham. Please proceed with your question.

Serge Belanger

Just a couple for us. First on the ADHD portfolio, the differentiation between your 2 products and the fact that they address slightly different patient segments. Should we expect the seasonality impacts to differ on each of the products? And then secondly, regarding Nucynta, I guess for Colleen, we saw some stabilization in the price from Q2 to Q3. Do you expect any additional movements going forward on the price level for Nucynta?

Colleen Tupper

Serge, just to clarify, do you mean Nucynta on the second question?

Serge Belanger

Yes. Thank you.

Colleen Tupper

Sure. So let me take that 1 on. Serge, broadly, yes, I would expect consistency here with a couple full quarters in with the authorized generic in the marketplace. We do not expect from that side that there'll be significant additional changes in the gross-to-net. Correct. Why don't you just take that question? Sure. As they're making decisions as they go into each new calendar year, that is a consideration. But as mentioned in the prior calls, with the gross-to-net as high as they are, there frankly isn't a whole lot more that we would expect on the volatility side from pricing.

Vikram Karnani

To take your question on ADHD, I think your question, Serge, was do the back-to-school dynamics play out differently for Azstarys and for Jornay PM given that we serve different patient types. So recall that Jornay PM about 80% of the prescriptions, 80% of the business is from pediatrics and adolescents. So when you think about back-to-school for Jornay PM, it's a really important time of the year. And Azstarys, given the different profile of the medicine, the split between pediatrics and adults is a little bit different. It's about two-thirds pediatrics and about a third adults. So the ratio skews a bit more towards the adults. That said, two-thirds of the business still does come from pediatrics. So back-to-school season is equally important for Azstarys as well. And so I think while we do play out to different patient types, and yes, you're right, the adult segment does play a little bit more of a role in Azstarys, broadly speaking, a large majority of both medicines' business comes from the pediatric segment. And that's why the back-to-school season is really important for both.

Serge Belanger

Great. Thank you.

Vikram Karnani

Thanks, Serge.

Operator

Our next question comes from Alexander Xenakis with Truist Securities. Please proceed with your question.

Alexander Xenakis

For Azstarys, it's great to see a return to growth. What growth rate are you building towards 2027? And without necessarily providing formal guidance today, what prescription growth trajectory and a normalized revenue base should investors use to assess success in 2027?

Vikram Karnani

Thank you, Alex. I don't think we're in a position to comment on specific numbers or percentages, either of growth in prescriptions or revenue. What I would say, though, is it is very, very encouraging to already see Azstarys return to growth. We expect that growth to continue. We would expect to see that growth accelerate from the levels that it's at right now. Recall that prior to the acquisition, Azstarys was promoted by a much smaller sales force and therefore being promoted to a much smaller HCP universe. With our expanded platform, we're now able to target in excess of 27,000 prescribers with 190 reps. Therefore, the expanded platform is definitely going to create a significantly higher awareness of Azstarys in HCP offices. As far as awareness creation with patients and caregivers directly, that was not done at all prior to the acquisition. And so this will be brand-new awareness creation for Azstarys, which we are in the process of beginning and supporting right now. And as you can imagine, those efforts have a little bit of lag built into when you see the impact from those efforts. So we look forward to keeping you updated on how this plays out, but we do expect to see growth increase and accelerate for Azstarys as we move into next year.

Alexander Xenakis

Great. Thanks.

Vikram Karnani

Thanks, Alex.

Operator

Our next question comes from David Amsellem with Piper Sandler. Please proceed with your question.

Alexandra von Riesemann

This is Alex von Riesemann on for David. How are you thinking about the longer-term growth runway of Jornay PM specifically, and how do you envision growth in both pediatric and adult segments? And then secondly, also on Jornay PM, how do you envision access evolving as the footprint of the product continues to grow, and with that in mind, do you see the gross-to-net creeping up for the product over time?

Vikram Karnani

Thank you. Thanks for the question. I think Jornay PM, if you take a step back and think about the fact that Jornay PM is a few years into its life cycle, and in spite of the fact that it's in a market with significant generic presence, we have still seen a tremendous amount of growth, both in prescriptions and revenue for Jornay PM. And part of this was related to the fact that prior to acquisition, the awareness of the brand, both with the HCPs and with patients and caregivers, was relatively low. And as we have kept you updated on our market share increases for Jornay PM, we've seen significant increase in growth as well as market share for Jornay PM in the last few quarters, in the last 2 years that we've owned the brand. We expect that given that we play in a significantly large market—I mean, if you take a step back and think about the overall market, 100 million overall prescriptions in 2025 in the ADHD market, a vast majority of that, almost 90%, are stimulants, and a big component of that are methylphenidates—when you think about the headroom for future growth for Jornay PM, and this comment is also true for Azstarys, given the differentiated profile that both of these medicines bring, given the significant lack of awareness that exists with both HCPs and caregivers and patients, we expect this growth to continue overall from a volume standpoint. And then maybe there's a question around gross-to-net.

Colleen Tupper

Yes, absolutely, Alex. So I think Jornay PM already benefits from a strong market access position with broad access, but we will always continue to look at expanding that. And what we would do is we're really looking to seek profitable, enhanced patient access. And so as we evaluate any of those opportunities, we really have an eye to overall net revenue and what are the volume gains and gross-to-net impact as those opportunities arise.

Alexandra von Riesemann

Thank you.

Vikram Karnani

Thanks, Alex.

Operator

We've reached the end of our question-and-answer session. I would now like to turn the floor back over to Vikram for closing comments.

Vikram Karnani

Thank you, everyone, for joining the call this morning and for your continued interest in Collegium. We appreciate your time and we look forward to updating you on our progress. Enjoy the rest of your day.

Operator

This concludes today's conference. Thank you for participating. You may now disconnect.

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