Cuộc họp công bố kết quả kinh doanh Q3 2026 của Axsome Therapeutics (AXSM): Doanh thu tăng 52%

Điểm tin chính

• Axsome Therapeutics đã báo cáo doanh thu quý 3 năm 2026 đạt 259,7 triệu USD, tăng 52% so với cùng kỳ năm ngoái và tăng 19% so với quý trước. Ban lãnh đạo cho biết danh mục sản phẩm thương mại đã vượt tốc độ doanh thu năm quy đổi là 1 tỷ USD.
• Doanh số bán sản phẩm ròng của AUVELITY đạt 207,6 triệu USD, tăng 53% so với cùng kỳ năm ngoái và tăng hơn 15% so với quý trước. Tổng số đơn thuốc tăng 40% so với cùng kỳ năm ngoái lên khoảng 302.000 đơn.
• Nhu cầu gia tăng mạnh mẽ ở các bệnh nhân từ 65 tuổi trở lên, chủ yếu phản ánh chỉ định điều trị chứng kích động ở bệnh nhân Alzheimer. Số đơn thuốc dành cho người mới dùng thuốc (new-to-brand) tăng 211% so với cùng kỳ năm ngoái và tăng 99% so với quý trước.
• Lỗ ròng giảm xuống còn 12,9 triệu USD, tương đương 0,25 USD mỗi cổ phiếu, so với mức 47,2 triệu USD, tương đương 0,94 USD mỗi cổ phiếu của cùng kỳ năm trước. Kết quả quý 3 năm 2026 bao gồm 26,4 triệu USD chi phí bồi thường bằng cổ phiếu.
• Axsome kết thúc quý với khoảng 314 triệu USD tiền và các khoản tương đương tiền. Ban lãnh đạo dự kiến số tiền hiện có sẽ đủ tài trợ cho các hoạt động dự kiến cho đến khi đạt dòng tiền dương.
• Các cột mốc sắp tới bao gồm dữ liệu Giai đoạn III của solriamfetol đối với chứng cuồng ăn trong quý 1 năm 2027 và ngày hành động PDUFA là ngày 1 tháng 5 năm 2027 đối với AXS-12 trong điều trị chứng mất trương lực cơ liên quan đến chứng ngủ róc.

Dữ liệu tài chính cốt lõi

Kết quả kinh doanh và hoạt động

AUVELITY

AUVELITY tiếp tục là động lực tăng trưởng chính của Axsome. Khoảng 302.000 đơn thuốc đã được ghi nhận trong quý, tăng 40% so với cùng kỳ năm ngoái và 14% so với quý trước. Điều này đánh dấu quý thứ hai liên tiếp tăng trưởng ở mức hai chữ số ở cả số đơn thuốc cho người mới dùng và tổng số đơn thuốc trên các nhóm tuổi.

Trong số các bệnh nhân từ 65 tuổi trở lên, mà theo ban lãnh đạo chủ yếu phản ánh chỉ định kích động do bệnh Alzheimer, tổng số đơn thuốc đã tăng 101% so với cùng kỳ năm ngoái và tăng 43% so với quý trước. Số đơn thuốc hàng tháng tăng từ khoảng 8.300 đơn trước khi phê duyệt lên khoảng 14.800 đơn vào tháng 9 năm 2026.

Đối với bệnh nhân dưới 65 tuổi, chủ yếu đại diện cho chỉ định rối loạn trầm cảm chủ yếu, số đơn thuốc cho người mới dùng tăng 27% so với cùng kỳ năm ngoái và 10% so với quý trước. Tổng số đơn thuốc tăng 33% so với cùng kỳ năm ngoái và 10% so với quý trước. Số đơn thuốc hàng tháng tăng từ khoảng 67.000 đơn trước khi mở rộng đội ngũ bán hàng lên khoảng 88.200 đơn vào tháng 9.

Axsome đã kích hoạt khoảng 8.200 bác sĩ kê đơn AUVELITY mới trong quý 3, tăng 49% so với quý trước. Khoảng 77.000 bác sĩ lâm sàng khác nhau đã kê đơn sản phẩm này kể từ khi ra mắt. Chăm sóc sức khỏe ban đầu chiếm gần 40% số bác sĩ kê đơn và 25% số đơn thuốc trong quý.

Tỷ lệ chi trả bảo hiểm vẫn duy trì ở mức khoảng 89% tổng số người tham gia, bao gồm 82% người tham gia bảo hiểm thương mại và khoảng 100% người tham gia kênh chính phủ. Ban lãnh đạo cho biết AUVELITY có thể đạt doanh thu đỉnh điểm hàng năm ít nhất 8 tỷ USD, dựa trên mức độ tiếp nhận sớm trong điều trị kích động ở bệnh nhân Alzheimer và đà tăng trưởng bền vững ở chỉ định rối loạn trầm cảm chủ yếu.

SUNOSI và SYMBRAVO

SUNOSI tạo ra hơn 64.400 đơn thuốc, tăng 15% so với cùng kỳ năm ngoái và 6% so với quý trước. Khoảng 17.650 bác sĩ lâm sàng đã kê đơn sản phẩm kể từ khi ra mắt, trong khi tỷ lệ chi trả của bên thanh toán bảo hiểm vẫn ở mức gần 82% số người tham gia trên các kênh.

SYMBRAVO ghi nhận hơn 25.000 đơn thuốc, tương ứng mức tăng trưởng 382% so với cùng kỳ năm ngoái và 7% so với quý trước. Tỷ lệ chi trả tổng thể của bên thanh toán đạt khoảng 57%, bao gồm 56% đối với bảo hiểm thương mại và 57% đối với kênh chính phủ.

Triển vọng từ ban lãnh đạo

Ban lãnh đạo dự kiến AUVELITY sẽ tiếp tục tăng trưởng ở cả hai chỉ định rối loạn trầm cảm chủ yếu và kích động do bệnh Alzheimer, nhờ vào sự gia tăng bệnh nhân mới bắt đầu điều trị, số đơn thuốc tái kê và sự thâm nhập sâu hơn vào kênh chăm sóc sức khỏe ban đầu. Công ty không cung cấp dự báo doanh thu cụ thể cho quý 4 năm 2026 hoặc năm 2027.

Mức chiết khấu từ giá gộp sang giá ròng của AUVELITY đã cải thiện lên khoảng giữa đến cao của mức 40% trong quý 3, trong khi SUNOSI tiến vào khoảng cao của mức 40%. Axsome dự kiến cả hai chỉ số này sẽ tăng nhẹ trong quý 4 do tính mùa vụ thông thường và các khoản dồn tích cho đơn thuốc được xử lý thanh toán trong quý 1 năm 2027.

Các cột mốc lâm sàng và pháp lý quan trọng được ban lãnh đạo nêu ra bao gồm:

• Solriamfetol trong điều trị chứng cuồng ăn: Kết quả sơ bộ Giai đoạn III của nghiên cứu ENGAGE dự kiến sẽ có trong quý 1 năm 2027.
• AXS-12 trong điều trị chứng mất trương lực cơ: Quá trình xem xét của FDA đang diễn ra, với ngày hành động PDUFA là ngày 1 tháng 5 năm 2027. FDA hiện không có kế hoạch tổ chức cuộc họp ủy ban tư vấn.
• AXS-20 trong điều trị tâm thần phân liệt: Thử nghiệm Giai đoạn III then chốt dự kiến bắt đầu vào nửa đầu năm 2027.
• AXS-17 trong điều trị động kinh: Các thử nghiệm lâm sàng dự kiến bắt đầu vào nửa đầu năm 2027.
• Solriamfetol trong điều trị rối loạn trầm cảm chủ yếu kèm buồn ngủ quá độ vào ban ngày: Việc hoàn tất tuyển chọn bệnh nhân Giai đoạn III cho nghiên cứu CLARITY dự kiến vào nửa đầu năm 2027.
• AXS-05 trong hỗ trợ cai thuốc lá: Kết quả Giai đoạn III của nghiên cứu SUMMIT dự kiến có vào nửa cuối năm 2027.
• Solriamfetol trong điều trị ADHD ở trẻ em: Kết quả Giai đoạn III của các nghiên cứu FOCUS-2 và FOCUS-3 dự kiến có vào nửa cuối năm 2027.
• Solriamfetol trong điều trị rối loạn làm việc theo ca: Kết quả Giai đoạn III của nghiên cứu SUSTAIN dự kiến có vào nửa cuối năm 2027.
• AXS-14 trong điều trị hội chứng đau xơ cơ: Việc hoàn tất tuyển chọn bệnh nhân Giai đoạn III cho nghiên cứu FORWARD dự kiến diễn ra trong quý 3 năm 2027.

Rủi ro và các điểm cần theo dõi

• Ban lãnh đạo cho biết thị trường điều trị chứng kích động ở bệnh nhân Alzheimer vẫn cần tăng cường giáo dục nhận thức đáng kể về việc nhận biết triệu chứng, chẩn đoán và điều trị. Do đó, tốc độ đón nhận của các bác sĩ lâm sàng có thể diễn ra ở các mức độ khác nhau.
• Tỷ lệ bỏ đơn thuốc ở chương trình Medicare nhìn chung cao hơn so với các kênh thương mại, mặc dù Axsome cho biết họ chưa ghi nhận bất kỳ hiện tượng bất thường nào ngoài các mô hình thông thường đối với đợt ra mắt điều trị chứng kích động do Alzheimer.
• Mức chiết khấu từ giá gộp sang giá ròng của SYMBRAVO vẫn nằm trong khoảng giữa của mức 80%, trong khi tỷ lệ chi trả của bên bảo hiểm đạt khoảng 57%. Ban lãnh đạo cho biết thời điểm đạt được các hợp đồng tiếp cận bổ sung là rất khó dự đoán.
• Dữ liệu đơn thuốc từ bên thứ ba có thể kém tin cậy hơn sau những thay đổi đối với các nhà thuốc báo cáo. Ban lãnh đạo ước tính tỷ lệ thu thập dữ liệu của IQVIA đã giảm xuống khoảng 90% và lưu ý rằng một chuỗi nhà thuốc đã ngừng báo cáo cho bên cung cấp dữ liệu vào tháng 10.
• Tiến độ của các sản phẩm đang phát triển vẫn phụ thuộc vào việc tuyển chọn bệnh nhân, kết quả nghiên cứu và quá trình xem xét của cơ quan quản lý. Công ty đã nhấn mạnh phản ứng với giả dược là một yếu tố cần cân nhắc trong thiết kế thử nghiệm lâm sàng cho chương trình AXS-20 điều trị tâm thần phân liệt dự kiến.

Những điểm nổi bật trong phần Q&A với các chuyên gia phân tích

Ban lãnh đạo cho biết chương trình phát mẫu thử AUVELITY cho chỉ định kích động do Alzheimer đang diễn ra với tốc độ tương tự như đợt ra mắt cho chỉ định rối loạn trầm cảm chủ yếu. Mặc dù Axsome không thể theo dõi chính xác liệu mẫu thử từ bác sĩ có đến tay bệnh nhân hay không, công ty đang nhận thấy sự tăng trưởng tích cực ở số đơn thuốc cho người mới dùng trong số các bác sĩ lâm sàng nhận được mẫu thử.

Về động lực từ phía đơn vị chi trả, công ty báo cáo tỷ lệ cấp phát thuốc cao sau khi đơn thuốc được kê và cho biết khả năng chi trả của bệnh nhân Medicare nhìn chung vẫn ở mức kiểm soát được. Ban lãnh đạo cũng cho biết không có sự gián đoạn đáng kể nào từ các kế hoạch Medicare Advantage và hiện không có điểm nghẽn vận hành nào liên quan đến phân phối, kê đơn điện tử hoặc hệ thống hồ sơ bệnh án điện tử.

Về mảng chăm sóc dài hạn, Axsome cho biết kênh này đang tăng trưởng với tốc độ tương tự như tốc độ báo cáo ở nhóm bệnh nhân từ 65 tuổi trở lên. Chu kỳ bán hàng có thể dài hơn do các quyết định liên quan đến viện dưỡng lão, các chuỗi nhà thuốc và các nhóm nhà cung cấp dịch vụ được ký hợp đồng, nhưng ban lãnh đạo kỳ vọng chăm sóc dài hạn sẽ trở thành nguồn cầu quan trọng cho AUVELITY.

Đối với AXS-20, ban lãnh đạo dự định phát triển thuốc này như một liệu pháp đơn trị liệu hàng đầu cho bệnh tâm thần phân liệt. Công ty đã nhấn mạnh tín hiệu về hiệu quả được ghi nhận trong một nghiên cứu đối chứng trước đó và việc không có tác dụng phụ về chuyển hóa như những điểm khác biệt tiềm năng.

Toàn văn biên bản cuộc họp báo cáo kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, and welcome to the Axsome Therapeutics Third Quarter 2026 Earnings Conference Call. My name is Kevin, and I'll be your operator for today's call. [Operator Instructions]

I will now turn the call over to Ashley Dang, Senior Director of Investor Relations. Ashley, please go ahead.

Ashley Dong

Thank you. Good morning, everyone. Welcome to Axon's Third Quarter 2026 Earnings Conference Call. Joining me today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; and Ari Maizel, Chief Commercial Officer, who will begin with prepared remarks. Mark Jacobson, our Chief Operating Officer; and Hunter Murdock, our General Counsel, will also be available for Q&A.

Before we begin, I encourage everyone to visit the Investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy and operational plans. Including research, development and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today. and the company disclaims any obligation to update such statements.

And with that, I'll hand it over to Herriot.

Herriot Tabuteau

Thank you, Ashley, and good morning, everyone. Axsome delivered another robust quarter across our business. driven by continued commercial progress and advancements in our industry-leading neuroscience pipeline. Our commercial portfolio generated $260 million in total revenue in the quarter. representing growth of 52% year-over-year, surpassing a $1 billion annual run rate. We expect sustained momentum for ABILITY driven by strong underlying demand growth in major depressive disorder and continued acceleration of new patient initiations in Alzheimer's disease agitation. The nosy continues to show persistent and steady growth.

And for Solriamfetol, our expanded sales team is driving important trial and adoption. Nick will discuss our financials for the quarter, followed by Ari, who will comment on our commercial business. In parallel with the commercial portfolio, our industry-leading neuroscience pipeline comprises 10 development programs, including significant label expansion opportunities, for Velti and Sunosi as well as novel product candidates with potential first-in-class and best-in-class profiles across areas of high unmet need in brain health.

I will review our recent pipeline progress later in the call. Overall, our commercial portfolio is growing and our industry-leading R&D portfolio is well positioned to potentially deliver multiple ways of innovation to patients.

I will now turn the call over to Nick to review our financials.

Nick Pizzie

Thanks, Ari, and good morning, everyone. Total revenue reached $259.7 million in the third quarter, representing accelerated growth of 52% year-over-year and 19% sequentially. The AUVELITY net product sales were $207.6 million, representing 53% year-over-year growth and an increase of over 15% sequential growth. Sequential increases over the past two quarters more than doubled the average quarterly increase prior to label expansion in Alzheimer's disease agitation. The SUNOSI net product revenue was $48.2 million in the third quarter representing 47% year-over-year growth. This consisted of $38.5 million in net product sales, $1.2 million in royalty revenue associated with sales and out-licensed territories, and $8.5 million in milestone revenue recorded related to cumulative ex U.S. net revenue.

SYMBRAVO net product sales were $3.9 million in the quarter, representing 88% year-over-year growth. The gross net discount for SYMBRAVO was in the mid-80% range. Gross net discounts for Avelity improved to the mid- to high 40% range. Sunosi also improved into the high 40% range for the third quarter. We anticipate gross to net discounts for both products to increase slightly in Q4 due to typical seasonality.

Turning to expenses. Cost of revenue in the quarter was $17.8 million compared to $11.9 million in the third quarter of 2025. Gross margin remained healthy in the low to mid-90% range. Research and development expenses were $50.6 million compared to $40.2 million in the third quarter of 2025, primarily reflecting costs associated with our ongoing late-stage clinical programs for solriamfetol AXS-14 and AXS-05. Selling, general and administrative expenses were $203.1 million compared with $150.2 million for the third quarter of 2025.

The increase versus prior year was primarily driven by commercialization activities for Availity and SIMBRAVA. SG&A was essentially flat quarter-over-quarter as the bulk of the original field force expansion is now reflected in our run rate. Finally, net loss for the quarter decreased to $12.9 million or $0.25 per share compared with $47.2 million or $0.94 per share in the third quarter of 2025. This improvement underscores the continued operating leverage in our business as revenue growth increasingly translates to the bottom line. The net loss of $12.9 million for the quarter included $26.4 million in stock-based compensation expense.

Turning to the balance sheet. We ended the quarter with approximately $314 million in cash and cash equivalents. This compares to $323 million at year-end 2025. We continue to expect that our current cash balance will be sufficient to fund anticipated operations through cash flow positivity.

And with that, I would like to turn the call over to Ari for a commercial update.

Ari Maizel

Thanks, Nick, and good morning, everyone. I'm pleased to share the progress across our portfolio of three approved medicines, particularly the growing momentum behind Albelity. Overall, total prescriptions reached approximately $302,000 in the third quarter, an increase of 40% year-over-year and 14% sequentially, significantly outpacing the antidepressant market, which grew 3% and 2% in the same time periods, respectively. In addition, Q3 marked the second consecutive quarter of double-digit demand growth for both new-to-brand prescriptions and total prescriptions across all age groups with acceleration across both indications. In the 65 years and older segment, which reflects primarily the Alzheimer's agitation indication, new-to-brand prescriptions grew 211% year-over-year and 99% sequentially.

New-to-brand prescriptions reflect new patient starts and are a key leading indicator of total prescription growth. In the quarter, total prescriptions in the 65 years and older segment grew 101% year-over-year and 43% sequentially. In the less than 65-year-old segment, which reflects primarily the major depressive disorder indication, new-to-brand prescriptions grew 27% year-over-year and 10% sequentially. Total prescriptions in the less than 65-year-old segment grew 33% year-over-year and 10% sequentially in the quarter. We expect momentum in new-to-brand prescriptions to continue, contributing to ongoing and increasing total prescription growth in the coming quarters.

Overall, Alvelity growth is being driven by both increased prescribing frequency among existing riders and continued acceleration in new writer activation. In the third quarter, we activated approximately 8,200 new AlbeliTY prescribers, representing 49% growth versus the prior quarter and bringing the total number of unique Albelity prescribers since launch to approximately 77,000. Our expanded Alvelity sales team is driving broader adoption across prescriber segments, particularly primary care, which remains the fastest-growing segment for Abelt in terms of both prescribers and prescription volume across both indications.

Primary care represented nearly 40% of prescribers and 25% of total prescriptions in the quarter. We expect primary care adoption to continue to grow in MDD and Alzheimer's agitation and remain an important driver of long-term growth for the overall brand. The breadth of avelity demand growth across indications, age cohorts, prescriber segments and settings of care is a positive signal of the impact AUVELITY is having on patients and prescribers throughout the U.S. We are very pleased with feedback of the clinical responses observed in real-world settings, which include rapid and sustained symptom relief, positive impact on quality of life and a manageable safety and tolerability profile for both MDD and Alzheimer's disease education patients.

Ability coverage remains at approximately 89% of total lives across channels, including 82% of commercial lives and approximately 100% of lives in the government channel. Our market access team is working closely with payers in both the commercial and government channels, and we expect patient access for Albelity in both the MDB and Alzheimer's agitation markets to continue to expand and evolve. Based on Abelity's initial uptake in Alzheimer's disease agitation and sustain momentum in MDD, Avelity is well positioned to generate at least $8 billion in annual revenue at peak.

Turning now to CynbRAVO, which grew 382% versus Q3 2025 and 7% sequentially to more than 25,000 total prescriptions. -- outperforming the migraine market, which grew 6% versus Q3 2025 and 4% sequentially. New prescriber growth from the neurology and primary care segment underscores the growing place in treatment for SYMBRAVO for patients who experience inadequate response to prior acute migraine treatment options. Prescriber and patient feedback consistently highlights Symbravo's rapid impact on migraine symptoms, the same response out to 24 hours and 48 hours and predictability of response across multiple migraine attacks.

Overall payer coverage remains at approximately 57% of lives covered across channels, including approximately 56% of commercial lives and 57% of government lives. We expect coverage for SyNBRAVO to expand and evolve moving forward.

Sunosi delivered another quarter of growth with more than 64,400 total prescriptions written during the quarter. representing 15% year-over-year growth and 6% sequential growth compared to the waste promoting agent market, which was flat compared to Q3 2025 and experienced a 2% increase versus the prior quarter. Nearly 17,650 clinicians have now prescribed Sunosi since launch, and we continue to maintain broad payer coverage of approximately 82% of lives covered across all channels. With an established commercial infrastructure, robust growth for ability in MDB and Alzheimer's disease agitation, continued progress for SIMRAVO and migraine and durable growth for Sunosi and EDS associated with narcolepsy and obstructive sleep apnea. Axsome is poised to drive demand across our novel medicines and positively impact patients throughout the United States for years to come.

I will now turn the call back to Herriot.

Herriot Tabuteau

Thank you, Ari. Alongside the growth of our commercial portfolio, our industry-leading neuroscience pipeline continues to advance toward a number of important clinical and regulatory milestones. I will now review our recent pipeline progress in key upcoming clinical and regulatory milestones.

Starting with our ongoing clinical programs in psychiatry. WibiliTy now approved for depression and Alzheimer's disease agitation, we have initiated development of AXS-05 for the treatment of smoking cessation, a third potential indication. In August, we initiated the SUMMIT Phase III trial of AXS-05 for the treatment of smoking cessation. This is a three-arm study with a primary endpoint of smoking abstinence at 12 weeks, we anticipate top line results from this study in the second half of 2027. We also continue to advance our label expansion clinical programs for solriamfetol across four indications, including ADHD, binging disorder, shift work disorder and major depressive disorder.

In ADHD, our recently launched FOCUS-2 and FOCUS-3 Phase III trials of solriamfetol in children and adolescents are enrolling with top line results from both studies anticipated in the second half of 2027. These two studies, if positive, together with the previously completed positive FOCUS Phase III trial of solar in adults would form the basis of an NDA filing for solriamfetol in the treatment of ADHD.

In bin heating disorder, targeted enrollment has been reached in our ENGAGE Phase III trial, and we are on track for top line results in the first quarter of 2027. The Top line results for our SUSTAIN Phase III trial of solriamfetol in shift work disorder are anticipated in the second half of 2027. An enrollment completion for our CLARITY Phase III trial evaluating solriamfetol in major depressive disorder with symptoms of excessive daytime sleepiness is anticipated in the first half of 2027.

Rounding out our psychiatry programs is the AXS-20, our novel selective PDE10A inhibitor. We have made meaningful progress with our clinical trial preparations, and anticipate initiating a pivotal Phase III trial in schizophrenia in the first half of 2027.

Turning to our neurology clinical programs. Our NDA for AXS-12 for the treatment of cataplexy in narcolepsy is currently under review by the FDA, with a PDUFA target action date of May 1, 2027. If approved, AXS-12 would provide a differentiated new treatment option for patients with cataplexy and further strengthen our growing sleep franchise.

For AXS-14, our FORWARD Phase III trial in fibromyalgia is advancing, and we anticipate completion of enrollment in the third quarter of 2027. If positive, the FORWARD study along with the previously completed positive Phase II and Phase III trials would support an NDA filing for AXS-14 for the management of fibromyalgia.

Finally, we are advancing AXS-17, our novel GABAA alpha 2,3 subtype selective positive allosteric modulator. We plan to initiate clinical trials for this molecule in epilepsy in the first half of 2027. Overall, our extensive late-stage pipeline continues to advance. Positioning us to continue to deliver innovation for patients and value for shareholders. I will now turn the call back to Ashley.

Ashley Dong

Thanks, Arie. This concludes our prepared remarks, and we'll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Kevin, please open the line.

Operator

[Operator Instructions] Our first question today is coming from KriedBerhando from Truth Securities.

Phần hỏi đáp

Unknown Analyst

On vanity, I was wondering if you can talk a little bit about the sample to paid conversion. Now that you have a full quarter of the agitation launch, how are the earliest patient cohorts progressing from samples to paid packs, maintenance prescriptions, et cetera. And is this in line with your internal expectations?

Ari Maizel

Yes. Thanks for the question. So we're sampling at a similar rate to what was observed in the MDD launch and demand for ADA samples is strong. Although we have visibility into the samples that are provided to HCPs, we do not have precise data on whether those samples are dispensed directly to patients. Now that said, we are seeing positive NBRx growth among sample HCPs and expect that trend to continue based on our expectations.

Operator

Our next question is coming from Rudy L from Wolf Research.

Guofang Li

Just a quick follow-up to Amit's question. So I think most investors to use TrekSaudi as a bar for ADA commercial uptake, which was launched like three years ago. Can you maybe help us understand the key differences now in market dynamics and the marketing strategy versus Saudi? Any color would be helpful.

Ari Maizel

Sure. Yes. As a reminder, we don't typically comment on products that are on our own. And as you know, ALVElIDYRexult are different products with different mechanisms and one would expect different launch dynamics, which is what we're seeing. As it relates to the market, there's still significant education required in this marketplace. In some ways, this is still a new and developing market with a little precedent.

And so from our perspective, there is a clear focus on educating on the clinical profile for ALT but there's still a significant opportunity to educate on agitation symptoms, identifying and diagnosing those symptoms as early as possible for patients and treating those symptoms in order to support patients and care partners and improve quality of life overall. So from our perspective, this is still a relatively new and developing market, but we're very encouraged by what we've seen thus far and see plenty of opportunity for ongoing education.

Operator

Next question is coming from Ash Verma from UBS.

Ashwani Verma

For ADA, I know you talked about that the launch has met your internal expectations, but it seems that it hasn't met investors' expectation with the stock down 40% to 45% since the launch has started. In Q3, like you had the sell side, you have come above that. But just when you think about the Q4 consensus, and 2027 consensus. Do you think that this is the right place? Or do you think that it needs to come down a little bit.

Nick Pizzie

Sure yes, so Q3, we came in at $207.6 million, and we don't give specific guidance on for Q4 or for 2027. But we did see robust growth from Q3 to Q2, and we expect to see continued growth in vanity specifically with the refills that we would see from the NBRx growth that we saw 26% growth sequentially Q2 versus Q1 and then 21% Q3 and Q2. So we would expect that to turn those NBRxs turning into TRxs.

Operator

Your next question today is coming from Leonid Timashev from RBC Capital Markets.

Leonid Timashev

I just want to ask on real-world payer dynamics. Obviously, you guys have a good coverage in the channels. But I guess, what are you seeing on the ground with respect to how patients are managing co-pays, how they're converting from if they're having any trouble converting from free to paid? Just anything you can comment there?

Ari Maizel

Yes. Thanks, Leo. I assume you're referring to Alzheimer's agitation patients specifically. And with Medicare, we've worked really hard to ensure access and coverage for patients. Obviously, every patient is different based on their coverage, based on their income. And what we've seen is good dispense rates for patients that are prescribed the product would suggest that, not only are they getting coverage, but the affordability has been manageable for them. Of course, that's not a universal truth for all patients. And we worked really hard to provide education and resources in order to support patients that may have challenges with affordability. But overall, we've been really pleased with how patients have been able to fill prescriptions once written?

Operator

The next question is coming from Marc Goodman from Leerink Partners.

Marc Goodman

Yes. Can you go back to the gross-to-net comment that you made and talk about the dynamics that impacted it in the third quarter, how you're expecting fourth quarter and 2027. It seems like it came down a little more than we expected in the quarter.

Nick Pizzie

Sure, Mark. Yes. So the GTN for the quarter improve to the mid- to high 40s in Q3, we were around 50% in Q2. So we would anticipate that, that GTN We shared, it will slightly increase in Q4. And the only reason for that is not to get into the accounting, but you need to accrue for the GTN for the scripts that will adjudicate in Q1. As always, we typically have two weeks of inventory on hand at the end of any given quarter. So those two weeks, we just need to accrue and incur that expense in Q4 for scripts that get adjudicated in Q1.

For 2027, I think you asked, Mark, how would we anticipate GTN to look for ability. Similar to 2026, low 50s is where we were in Q1, approximately 50% in Q2, mid-high 40s we shared in Q3 and a slight tick up from that Q3 number this quarter.

Operator

Next question today is coming from Jason Gerberry from Bank of America.

Jason Gerberry

I have a non-ability ADA question. So just on the Phase III start for AXS-20 in schizophrenia. I'm curious how you guys are thinking about approaching this trial in a setting where we're seeing a trend of rising placebo rates, placebo responses in schizophrenia trials. Anything that unique that you guys think you can employer deploy in a Phase III trial design to help mitigate that just general risk in endeavoring in a schizophrenia Phase III.

Herriot Tabuteau

Thanks for the question. So the placebo response is something that we think about quite a lot as we design all of our studies. We had experience dealing with the high placebo response rate in other indications. For example, MDD is notorious for having a high placebo response rate. ADHD, same thing. And even when we conducted parallel group trials, we've been able to implement a lot of bells and whistles. So these are small changes to our clinical trial protocols, some of which are proprietary, which we've followed over the past several years, and we fully intend to use those in any study that we would design in psychiatry.

Operator

Our next question is coming from David Amsellem from Piper Stanley.

David Amsellem

So I wanted to drill down on the long-term care date and how you're thinking about that opportunity in ADA as we move through '27, what's your dialogue been like with institutions and just remind us how you're thinking about the opportunity in LTCs relative to the broader ADA opportunity?

Ari Maizel

Yes. Thanks, David. LTC as a channel is performing well thus far with growth rates that are similar to what we reported for patients 65 and older. The response to AVELITY's clinical roil has been very positive, and there's a clear value proposition for LTC facilities to prescribe Alvelity compared to other treatment options. As you know, LTC sales involve multiple nursing home stakeholders. LTC pharmacy chains, provider groups that are contracted and care for residents. And so it is distinct from community settings where the HCP is the primary target. Although the sales cycle can be a little longer in LTC facilities, we are pleased with early progress and believe that it will be an important source of business for AbeliTY moving forward.

Operator

Our next question today is coming from Sean Loman from Morgan Stanley.

Sean Laaman

Open the under 65 TRx with Ovelity, how much of that growth reflects underlying demand versus the expanded sales force? And when should the productivity benefits from that expansion mature?

Herriot Tabuteau

Yes. As it relates to both the approval of ADA and the sales force expansion, we've seen significant growth which we expect to continue as the sales force continues to become more effective and more productive. This expectation is really based on what we've seen as it relates to new patient initiations. So as you mentioned, 65 and younger, we saw a significant growth in NBRx, which is the metric we use to track MDD, NBRx for patients under 65 grew 27%. And when you think about where we were before the sales force expansion, First patient 65 and younger, monthly TRx were approximately 67,000. And as of September 2026, TRx were approximately 88,200 representing approximately 32% growth. So we're very pleased with the early impact of the sales force expansion, and we expect as that team becomes more productive and more effective growth trends will continue.

Operator

Next question today is coming from Malcolm Haltermann from BMO Capital Markets.

Malcolm Hoffman

Quarter Tourette's syndrome was noted as an opportunity for AXS-20 previously, but seems to be removed from the pipeline slide today. Does that reflect a formal development decision or just prioritization of schizophrenia?

Ari Maizel

Thanks for the question. There is no change. That's still of interest. We're that's just further back in the pipeline, so we wanted to highlight the later-stage programs. But there's no change to our plans there.

Operator

Next question is coming from Andrew Sen from Jefferies.

Lin Tsai

The NBRx data for the 65-plus age group looks quite healthy, I think 99% quarter-over-quarter. So when do you think the NBRx inflection will meaningfully cash up to TRx exactly? Are you talking days, weeks away? Or is this kind of a month to quarter away kind of thing?

Herriot Tabuteau

Yes. Thanks for the question. As it relates to the under 65. We've been very pleased the MRx as you mentioned -- sorry, for 65 and older grew 211% year-over-year. When you look at TRx prescription volume for the ADA indication, prior to launch, monthly TRx for patients 65 and older were approximately 8,300.

And as of September 2026, TRx were approximately 14,800 representing 78% growth since the approval. So we're pleased. We expect the upward trajectory to continue and our focus on new patient initiations will also continue, which will support ongoing and persistent demand growth.

Operator

Your next question is coming from Joseph Thome from TD Colin.

Joseph Thome

Maybe just talk about where these patients are coming from in terms of prior treatment. Are these patients in the ADA segment? Are they treatment naive? Are they coming from prior SALT? Or are they coming from prior SNRI off-label use, maybe where are you finding maybe the most interest in terms of the specific patient population? And I guess, if you're interacting with a physician and maybe they're not ready to use ability for their ADA patient yet? Maybe what's the main reason? And how can you address that?

Herriot Tabuteau

Yes. Thanks, Joe. When we look at prior treatment experience, it really does cover a broad spectrum of prior treatments, ranging from generic antidepressants, generic antipsychotics, to branded antipsychotic. The feedback that we've heard is that patients who are both naive to treatment as well as treatment experience have been prioritized for early trial from the providers who have prescribed in the early days of launch.

Regarding barriers to adoption, I would say there's not much in the way of barriers outside of just gaining comfort with the clinical profile and identifying the first patient to try it with. So there hasn't been anything in particular that has stood out to us. But as you know, with any new product launch, raising education and awareness is really important and some clinicians are more comfortable writing very early into a launch where others need some additional education before trying for the first time.

Operator

Next question today is coming from Suneja from Guggenheim Securities.

Yatin Suneja

I wanted to maybe ask a question on the narcolepsy review. Anything you are able to share, maybe also put in perspective how are you thinking about the market, the segment of the market where the competitive dynamics are shifting on the narcolepsy space?

Hunter Murdock

Jon, this is Mark. I'll take the first part of that. So with respect to the review and review is progressing as expected. They are just under six months to go. Nothing out of the ordinary from where we are at this stage. Reminder, the PDUFA date is May 1. So launch -- prelaunch activities are underway. I turn just one other thing, a reminder, FDA doesn't currently plan to hold an AdCom. And I'll turn it over to Ari for the second part of the question.

Ari Maizel

Yes, we're really pleased with the AXS-12 clinical profile that's been demonstrated across our clinical trials. And given the heterogeneity in the narcolepsy market and the inconsistent clinical response that patients have with existing medications, we believe the more treatment options, the better.

Operator

Next question is coming from Denver net from Wells Fargo.

Unknown Analyst

Just on ability, I wanted to touch back again on the adoption ramp that you're seeing in AD agitation. Are there any natural bottlenecks within the system that you just have to continue with given this is a new indication for ability? So like anything in terms of distribution or updating hospital EMR systems. Just is there anything that needs to naturally happen that might maybe open up this Ad agitation launch a bit more?

Herriot Tabuteau

Yes. Thanks, Ben, for the question. In terms of the ramp, we shared on the prepared remarks that NBRx in 65 and older grew 211% year-over-year and TRx have grown about 78% since the approval. So we're pleased with the progress we've made in terms of adoption. Related to the bottlenecks, there are no major bottlenecks that we can see. I think in the early days, certainly, EMR systems and e-prescribing systems need to be updated with new dosage and administration forms and things of that nature, but there's nothing standing in the way of prescribing at this point in time.

Operator

Our next question is coming from Brian Skorney from Baird. .

Unknown Analyst

Back on Avelle, just trying to get a feel for any prescription abandonment you're seeing, I would assume the vast majority of Medicare patients would have already covered their annual out-of-pocket cap. Is that the case? And are you seeing any active formulary management in the Advantage plans? And just wondering, are you seeing any disruption due to all the advantage plans that have been shut down? Or do you anticipate that being kind of a headwind or a tailwind going into next year?

Herriot Tabuteau

As it relates to abandonment, generally speaking, abandonment in Medicare is generally higher than what is observed in commercial -- and certainly, that's been our observation if you compare ADA and MDD. However, there's nothing outside of the ordinary as it relates to abandonment. And there's really been no disruption regarding Medicare Advantage plans. We've worked really hard to secure access with no PA requirements. And the feedback we've received is that patients are getting access and filling prescriptions at a very high rate. So overall, we feel very good about the Medicare dynamics for agitation.

Operator

Next question is coming from Ami Fadia from Neiman Company.

Ami Fadia

Just with regards to the upcoming data readouts for solriamfetol in binding disorder. From a commercial standpoint, what type of profile would be competitive in terms of the efficacy and the safety profile that you're looking to see from the results?

Herriot Tabuteau

Thanks for the question. This will be the first study that we've conducted in banking disorder. So what we're looking to see, first of all, is the separation from placebo for the two doses that we're testing. The other thing that we're looking for is a safety profile, which is consistent with the safety profile that have been established for sorifitol. And so we like the fact this is a drug which is very efficacious in the current indications and which is also incredibly well tolerated.

So we think that given that there's only one other product that is currently approved in the marketplace, which is highly scheduled and which also has a service side effect drawbacks, should we be able to deliver another product which not only efficacious, but which we know is well tolerated, then we think that the marketplace would welcome that, and it would be a significant advance of patients.

Operator

Next question is coming from David Ho from Deutsche Bank.

David Hoang

I want to ask about -- we have, obviously, visibility to third-party vendor script trends going through October for several weeks. From your end how to the extent you have data, how are those tracking versus your expectations? And should we be thinking about any impact of seasonality or other things in Q4? For albeit, that is.

Herriot Tabuteau

Yes. Thanks for the question, David. Q4 is shaping up based on our expectations, continued growth in both indications. Obviously, we still have two months left in the quarter. Our team is focused on driving NBRx growth across both indications. And continued penetration of primary care setting. So I think it's premature to suggest what Q4 and obviously, we don't guide on quarters moving forward, but we are feeling very good about the overall business trends and look forward to closing out the year on a high note.

Operator

Next question is coming from Greg Savannes from Mizuho.

Graig Suvannavejh

Just wanted to stay on the prescription data. Could you comment just on capture rates between Symphony and IQVIA, I think, by our outlook, maybe IQVIA capture rate stayed relatively consistent, but maybe ticked up higher for Bloomberg Symphony data. Maybe you can comment on what you saw for this last quarter.

Nick Pizzie

Sure, Graig. Yes, capture rate this quarter did appear to fluctuate a bit potentially due to the addition of new pharmacies with the launch specifically IQVIA seems to be impacted the most, that decreased to somewhere around 90%. Additionally, we remain aware that a pharmacy chain stopped reporting scripts in October, to one of the data providers, which may also be impacting the weekly TRxs or NBRx numbers. Obviously, as a third-party provider. We don't have any other additional detail around that. but just we aren't made aware of that.

Operator

Our next question is coming from Matthew Hershenhorn from Oppenhaim.

Matthew Hershenhorn

On all the progress. First, we were wondering about belipodectin schizophrenia, just as you initiate the Phase III early next year. how you're envisioning beyond that potential real-world advantages just based on the mechanism compared to the profiles of some of the other novel agents out there like Cobian KLA basically, what unmet needs do you still see in the market currently that believe that, that could potentially address just thinking through the mechanism? And if you could please comment on your current appetite and capacity for additional BD deals, that would be great?

Herriot Tabuteau

So what we like about this novel PD Tina inhibitor is that already in a controlled study, there was a very strong efficacy signal. And also given the mechanism of action, one of the benefits, which was seen in that study and also in animal studies is the lack of metabolic side effects. So that's just a highlight of the favorable safety profile of this product candidate. So if you can maintain or generate greater efficacy than is seen with the current agents as well as getting rid of some of very serious side effects that are seen with at antipsychotics.

Then we think that, that would be a very meaningful advance to patients with schizophrenia. Now in addition to that, we believe that is an ecom of action, may have relevance for other indications. So we've mentioned to Rett syndrome, but there are other indications too, that we are contemplating, evaluating it with this novel mechanism of action.

Nick Pizzie

As it relates to -- sure, I will just -- I think it was a second question. I guess not got there on BD. As it relates to additional BD deals, -- we did do the two transactions over the last couple of quarters, specifically around schizophrenia.

And epilepsy as of 17 and AXS 20. And those deals from a financial perspective made sense. We feel like we can tuck them and develop them in our pipeline, but importantly, it does not impact our investment strategy in driving growth for ALLY.

Operator

Next question is coming from Myles Minter from William Larry. .

Myles Minter

Just on -- sorry, appetite for binding disorder in the ENGAGE study. You mentioned that target enrollment had been achieved, but the enrollment hasn't necessarily been complete. Is that just sort of like a 10% buffer above the 450 patients that you expect or you changing enrollment somehow? And then just anything on potential dose response between the 150mg and the 300mg placebo. I don't think you saw that in ADHD, but if there's a possibility of seeing here and being sort of?

Herriot Tabuteau

So enrollment is basically completed, and we are on track to report top line results in the first half of the first quarter. So we're done. And that the language that we put in there is, as you know, when you're enrolling clinical trials, even when you do complete enrollment, there might be patients who are still in screening and it is typical to it is customary to allow those patients to percolate through the system. But where we completed enrollment. And so we're very confident in reporting top line results shortly in the first quarter.

Operator

Our next question today is coming from Madison Alati from B. Riley Securities.

Madison Wynne El-Saadi

I have one on AXS 20. Is this something you think would have efficacy on top of a D2 antagonist or even a muscarinic compound without increasing the movement disorder risk? Or is this something that the team envisions as ultimately being a potential first-line therapy?

Herriot Tabuteau

So we're developing it as the first-line therapy studies that have been conducted have been with X20 over lift deck as a single agent. So we would be replicating that study Phase III trial.

Operator

Our next question is coming from Ram Sabarad from H.C. Wainwright.

Raghuram Selvaraju

With respect to product revenue, I was just wondering if you could provide us with any additional color on how you expect covered lives percentages to evolve for SINA over the course of the remainder of this year and into early 2027? And when do you anticipate the vast majority of covered lives to ultimately have access to that product? And then with respect to AXS-14 in fibromyalgia. Can you just give us a sense of the timing of the lease of top line data from the Phase III program, assuming that you complete enrollment in line with your previously stated time line guidance? -- as well as what the implications of this might be for the potential timing of an NDA submission. .

Nick Pizzie

I'll start with the question on SYMBRAVO access. Obviously, we're engaged with payers in both the government and commercial channels. As you know, it's very difficult to predict timing of any new access contract, but we have been encouraged by the ongoing dialogue and continue to focus on expanding and evolving SymRaVo access. So I can't give you a specific increase in covered lives moving forward, but we are continuing to engage on CINRAVO, which has really established itself as a meaningful treatment option, particularly for patients who have had inadequate response to prior acute migrant treatment. So we'll share additional updates as we have them.

Herriot Tabuteau

So to the second part of your question regarding XS 17, the time line for reporting data is a little hard to predict because this is a randomized withdrawal study. So we've given guidance as to enrollment. So once the study enrolls, then the way that randomized studies work is you wait for the prespecified number of relapses. Now as it relates to timing of filing of an NDA we would be ready to file an NDA very shortly after we finish the study. So typically, this is roughly six months. In this case, it could be less than that. And the reason for that is that this would be a resubmission.

As a reminder, we have completed already two positive studies, the Phase II trial in a Phase III trial. So within six months, of reporting top line results for the currently enrolling study, we would be ready to file an NDA.

Operator

Our next question is coming from Pete Travels from Cancer Pontone.

Unknown Analyst

This is Samantha on the line for Pete. Congrats from the quarter, for AXS-12 or reboxetine with the first approval of an orexin 2 receptor agonist, how are you thinking about the underlying commercial opportunity for reboxetine in the narcolepsy market? And more specifically, had discussions with payers around the profile and possible pricing? And how are you thinking about commercialization efforts given this new entrant, but sizable opportunity, which I believe you estimate to be about 185,000 in the U.S.

Herriot Tabuteau

Yes, thanks for the question. As I shared earlier, we're really pleased with the profile of AXS-12 that we saw in the clinical trials. And also that patients in this market have really a consistent response to existing medications. So we believe that AXS-12 as a treatment option will be well received and adopted. Our engagement with payers thus far has been very positive. They understand that cataplexy is a debilitating symptom, often unresolved for many narcolepsy patients. And we expect there to be a place in treatment for AXS-12. We don't typically comment on pricing or access dynamics prior to launch. But we feel good about the nature of our dialogue with payers thus far and look forward to a potential approval.

Operator

We reach of our question-and-answer session. I'd like to turn the floor back to Herriot for your further or closing comments.

Herriot Tabuteau

Thank you. Axsome continues to make important progress across the business. Our commercial portfolio is growing at scale with substantial further growth across both major depressive disorder in Alzheimer's disease agitation. Our pipeline is also advancing towards key clinical and regulatory milestones that further expand the long-term potential of our singular CNS portfolio. We are executing against our strategic priorities. The fundamentals of our business only continue to improve and we are well positioned to close the year strong and enter 2027 with significant momentum. Thanks all for joining us, and have a great day.

Operator

Thank you. That does conclude today's teleconference. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.