Cuộc họp báo cáo kết quả kinh doanh quý 3/2026 của Aquestive Therapeutics (AQST): Đánh giá của FDA đối với Anaphylm và 90,3 triệu USD tiền mặt

Các điểm chính

• Aquestive Therapeutics (NASDAQ: AQST) đã nộp lại hồ sơ xin cấp phép cho màng ngậm dưới lưỡi epinephrine Anaphylm trước khi kết thúc quý 3/2026. FDA đã ấn định thời gian xem xét 6 tháng với ngày ra quyết định là 16/03/2027.
• Doanh thu quý 3/2026 giảm xuống 7,6 triệu USD từ mức 12,8 triệu USD cùng kỳ năm ngoái, chủ yếu do biến động theo quý của các đơn đặt hàng sản phẩm Suboxone. Doanh thu 9 tháng tăng 14% lên 35,8 triệu USD.
• Công ty báo cáo lỗ ròng quý 3 là 16,5 triệu USD, tương đương 0,13 USD trên mỗi cổ phiếu pha loãng, so với mức 15,4 triệu USD, tương đương 0,14 USD trên mỗi cổ phiếu pha loãng trong quý 3/2025.
• Tiền và các khoản tương đương tiền đạt tổng cộng 90,3 triệu USD tính đến ngày 30/09/2026, không bao gồm khoản thanh toán trả trước 10 triệu USD cho Libervant nhận được vào tháng 10. Ban lãnh đạo dự kiến con số này sẽ đạt hơn 70 triệu USD vào cuối năm.
• Aquestive duy trì dự báo cho cả năm 2026 với doanh thu từ 46 triệu USD đến 50 triệu USD và lỗ EBITDA đã điều chỉnh từ 30 triệu USD đến 35 triệu USD.
• Công tác chuẩn bị ra mắt Anaphylm bao gồm khoảng 75 đại diện bán hàng tiếp cận khoảng 8.000 đến 8.500 bác sĩ kê đơn ưu tiên cao, chủ yếu là các bác sĩ dị ứng, nếu sản phẩm nhận được sự phê duyệt của FDA.

Kết quả tài chính chính

Trong 9 tháng đầu năm 2026, doanh thu tăng 14% lên 35,8 triệu USD từ mức 31,5 triệu USD. Doanh thu bản quyền và nhượng quyền tăng lên 7,5 triệu USD từ 2,7 triệu USD, chủ yếu phản ánh 5 triệu USD doanh thu bản quyền liên quan đến Zevra.

Lỗ ròng 9 tháng thu hẹp xuống 47,4 triệu USD từ mức 51,9 triệu USD. Kết quả năm 2026 bao gồm khoản lỗ một lần 11,7 triệu USD do tất toán nợ; nếu không tính khoản này, lỗ ròng là 35,7 triệu USD. Lỗ EBITDA đã điều chỉnh cải thiện xuống 19,2 triệu USD từ mức 35,5 triệu USD.

Kết quả hoạt động kinh doanh và vận hành

Anaphylm tiến gần đến ngày quyết định của FDA

Ban lãnh đạo cho biết quá trình xem xét hồ sơ nộp lại của Anaphylm từ FDA tập trung vào các mục trong thư phản hồi toàn bộ (CRL). Aquestive đang phản hồi các yêu cầu thông tin nhưng báo cáo không có diễn biến mới nào trong quá trình xem xét.

Mặc dù công ty đang vận động để có quyết định nhanh hơn, họ vẫn tiếp tục lập kế hoạch xoay quanh ngày ra quyết định 16/03/2027 vì mốc thời gian của FDA vẫn nằm ngoài tầm kiểm soát của công ty.

Các công tác chuẩn bị thương mại đang được triển khai. Aquestive đang tuyển dụng các quản lý bán hàng khu vực và dự kiến triển khai khoảng 75 đại diện bán hàng tới 8.000 đến 8.500 bác sĩ kê đơn mục tiêu. Trọng tâm ban đầu sẽ là các bác sĩ dị ứng có tần suất kê đơn cao, cùng một số bác sĩ nhi khoa và bác sĩ tai mũi họng được lựa chọn.

Công ty đã tổ chức các cuộc thảo luận trao đổi thông tin trước khi được phê duyệt với 4 công ty quản lý phúc lợi dược phẩm (PBM) lớn nhất Mỹ và nhiều chương trình bảo hiểm cấp dưới. Ban lãnh đạo xác định phạm vi chi trả của bên thanh toán, mức độ tiếp nhận của các bác sĩ mục tiêu và hiệu quả chi tiêu là những thước đo chính cho việc triển khai ra mắt trong năm 2027.

Ban lãnh đạo đang định vị Anaphylm dựa trên tốc độ đáp ứng dược lực học, cùng với tính di động, dễ sử dụng và độ bền. Giám đốc Y khoa Matthew Greenhawt cho biết các thông số huyết áp đạt đỉnh trong khoảng 5 đến 8 phút và phản ứng nhịp tim trong 8 đến 11 phút qua các nghiên cứu liên quan. Ông cho biết kết quả so sánh cho thấy đỉnh nhịp tim sớm nhất là khoảng 11 phút, với các chỉ số khác diễn ra sau 19 phút.

Bên ngoài nước Mỹ, Aquestive dự kiến sẽ nộp hồ sơ đăng ký Anaphylm tại Canada trước khi kết thúc năm 2026 và tại Châu Âu trong quý 1/2027. Các cuộc thảo luận cấp phép ngoài Mỹ vẫn đang tiếp tục.

Việc cấp phép Libervant mang lại tiền mặt trả trước và tiền bản quyền tiềm năng

Aquestive đã cấp quyền thương mại hóa độc quyền tại Mỹ đối với màng ngậm má diazepam Libervant cho Eton Pharmaceuticals. Aquestive đã nhận được 10 triệu USD trả trước và có thể nhận lên tới 47,5 triệu USD cho các mốc phát triển pháp quy và thương mại, cộng với tiền bản quyền ở mức khoảng 15% doanh thu ròng hàng năm tại Mỹ.

Aquestive sẽ tiếp tục là nhà sản xuất và cung ứng độc quyền theo một thỏa thuận dài hạn. Ban lãnh đạo dự kiến Libervant sẽ có mặt trên thị trường vào năm 2027 nếu được phê duyệt cho các cơn co giật bùng phát ở bệnh nhân động kinh.

Danh mục phát triển AdrenaVerse

Ban lãnh đạo mô tả năm 2027 là một năm quan trọng đối với nền tảng tiền dược epinephrine AdrenaVerse. Công ty mục tiêu tạo ra dữ liệu lâm sàng có ý nghĩa cho AQST-108 trong điều trị viêm da cơ địa và thúc đẩy các chỉ định bổ sung thông qua giai đoạn chứng minh khái niệm (proof of concept). Công ty không tiết lộ các chỉ định khác đang được xem xét.

Dự báo của ban lãnh đạo

Triển vọng tiền mặt bao gồm khoản thanh toán trả trước 10 triệu USD từ Eton nhận được vào tháng 10 và không bao gồm khoản tài trợ có điều kiện từ RTW và Oaktree.

Nếu Anaphylm được phê duyệt đúng thời hạn quy định và các điều kiện khác được đáp ứng, Aquestive dự kiến sẽ tiếp cận khoản vốn 75 triệu USD theo thỏa thuận tài trợ chiến lược RTW và 20 triệu USD khác thông qua gói vay có kỳ hạn từ Oaktree. Ban lãnh đạo cho biết các nguồn lực này, cùng với thanh khoản hiện có, sẽ hỗ trợ việc chuẩn bị ra mắt, thương mại hóa ban đầu và đầu tư có chọn lọc vào danh mục sản phẩm.

Rủi ro và các điểm cần theo dõi

• Sự phê duyệt và thời gian quyết định của FDA vẫn chưa chắc chắn, mặc dù đã ấn định ngày ra quyết định là 16/03/2027.
• FDA có thể tiến hành hoạt động thanh tra bổ sung, bao gồm tại các cơ sở lâm sàng hoặc nhà máy sản xuất của Aquestive ở Mỹ.
• Thành công thương mại phụ thuộc vào việc ký kết hợp đồng với bên thanh toán, khả năng đưa vào danh mục thuốc được chi trả và mức độ chấp nhận của bác sĩ. Ban lãnh đạo chưa công bố giá bán Anaphylm.
• Doanh thu quý 3 chịu ảnh hưởng bởi thời điểm đặt hàng Suboxone, cho thấy biến động tiềm ẩn theo quý trong doanh thu sản xuất.
• Khả năng tiếp cận khoản vốn bổ sung 95 triệu USD từ RTW và Oaktree phụ thuộc vào việc Anaphylm được phê duyệt và đáp ứng các yêu cầu khác.

Điểm nhấn phiên Hỏi & Đáp với chuyên gia phân tích

• Chiến lược ra mắt: Ban lãnh đạo lên kế hoạch tập trung vào đối tượng bác sĩ kê đơn thay vì chiến dịch trực tiếp tới người tiêu dùng trên quy mô lớn ngay lập tức. Chi tiêu cho người tiêu dùng rộng rãi hơn có thể tăng lên khi các cơ hội thương mại phát triển.
• Khả năng tiếp cận của bên thanh toán: Công ty dự định sử dụng dữ liệu lâm sàng của Anaphylm để hỗ trợ các cuộc thảo luận về phạm vi chi trả và bất kỳ mức giá chênh lệch nào so với các thiết bị tiêm tự động generic. Các công cụ hỗ trợ bệnh nhân dự kiến bao gồm trung tâm hỗ trợ (hub) và hỗ trợ đồng chi trả, mặc dù thông tin chi tiết vẫn chưa được quyết định.
• Phạm vi xem xét của FDA: Lãnh đạo mảng quản lý pháp quy cho biết việc xem xét hồ sơ nộp lại nhằm tập trung vào các mục chưa giải quyết trong thư phản hồi toàn bộ thay vì đánh giá lại toàn bộ hồ sơ đăng ký.
• Sự biệt hóa cạnh tranh: Ban lãnh đạo nhấn mạnh đến phản ứng dược lực học, tính di động và tính dễ sử dụng. Công ty cho biết tình hình kê đơn neffy đã được xem xét khi xây dựng danh sách mục tiêu, mặc dù tổng sản lượng kê đơn epinephrine mới là yếu tố lớn hơn.
• Sự sẵn sàng về sản xuất: Aquestive cho biết nhà máy sản xuất tại Mỹ của công ty đã chuẩn bị sẵn sàng cho cuộc kiểm tra tiềm năng của FDA và sẽ hỗ trợ Anaphylm cùng Libervant bên cạnh hoạt động kinh doanh sản xuất hiện tại.

Toàn văn biên bản cuộc họp kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good day, and thank you for standing by. Welcome to the Q3 2026 Aquestive Therapeutics, Inc. Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Faith Pomeroy-Ward from Aquestive.

Faith Pomeroy-Ward

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, President and Chief Executive Officer; and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the third quarter ended September 30, 2026, and a business update on recent developments, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Matt Greenhawt, Chief Medical Officer; Melina Cioffi, Senior Vice President, Regulatory Affairs; Sherry Korczynski, Chief Commercial Officer; and Dr. Matthew Davis, Chief Development Officer.

As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call and related supplemental materials will be made available on Aquestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of third quarter 2026 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the Investors section of Aquestive's website.

During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in yesterday's earnings release as well as the risks and uncertainties affecting the company as described in the Risk Factors section and in other sections included in the company's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 4, 2026, and in its subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval and commercialization of its products and other matters related to operations.

Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements or outlook or guidance after the date of this conference call, whether as a result of new information, future events or otherwise, except as required under applicable law.

Now I would like to turn the call over to Dan.

Daniel Barber

Good morning, and thank you for joining us today. This morning, I am pleased to tell you that we continue to execute right on schedule. In March, I told you that we would resubmit our Anaphylm epinephrine sublingual film application before the end of the third quarter, and we did. I also told you that we would out-license Libervant diazepam buccal film rather than launch it ourselves, and we did. I told you that we would refinance our debt before principal payments became due in June, and we did. I told you we expected to have $70 million or more of cash and cash equivalents at year-end, and I'm pleased to tell you that we now expect to end the year with more than $70 million in cash and cash equivalents.

In fact, as we sit here today, we are right where we expected to be. Our lead asset, Anaphylm, is under review with the FDA and has an assigned goal date that is only 132 days away or if you are an investor, since this is our earnings call, only 88 trading days. We are now focused on the next set of deliverables in our execution story. Our organization is ramping up for the U.S. launch of Anaphylm following FDA approval, and we are now hiring our district sales managers. We expect to file Anaphylm in Canada before the end of the year, and we are on track to file in Europe in the first quarter of next year. Our ex-U.S. licensing activities also continue, and we expect to have more to say in the months to come.

Now let's talk more about Anaphylm in the U.S. Everywhere I go and everyone I talk to in the allergy community can align behind one important concept. When a person is having a severe allergic reaction, the only thing they care about is making it stop as fast as possible. That's it. And that's where we believe Anaphylm will shine if approved by the FDA. Stopping a severe allergic reaction is a function of many things, including having a rescue product with you, using a rescue product without hesitation and having your symptoms abate quickly. That is why we believe speed is the ultimate differentiator, and we will continue to focus on this as we interact with the allergy community.

Our presentations at the upcoming American College of Allergy, Asthma and Immunology in Phoenix this month will highlight these views. This is also why I continue to see the opportunity for Anaphylm as significant. I continue to believe the market will transition from auto-injectors to new and improved technologies like Anaphylm. The market remains large and growing. We expect the overall U.S. market for epinephrine products measured by total prescriptions to once again grow year-over-year in 2027, and we see plenty of opportunity for continued market growth in the years to come. From a development standpoint, we are answering the FDA's information requests as we receive them and we'll continue to do so. At this time, we have nothing new to report on the review.

In terms of timing, while the FDA has assigned a 6-month review period, we remain prepared and hopeful for the possibility of an earlier decision. However, we do not control the FDA's time lines or how they prioritize their workload. Therefore, we are keeping our expectations on receiving its decision by March 16, 2027. In terms of expectations, we recognize that our story in 2027 will be one of execution. As we look towards a spring launch of Anaphylm, if approved by the FDA, I'd like to outline for you how we will judge success in 2027. In other words, what are the green shoots to look for in 2027.

First, we are determined to show ongoing progress with payers by both percentage of covered lives and quality of coverage. We will update you as these happen. We have engaged in the pre-approval information exchange or PIE discussions with the top 4 PBMs in the country, along with many downstream plans, and we'll continue to advance productive dialogue as much as possible prior to approval. Second, we want to see uptake in the places where we show up. Post launch, we will provide you with a view of our progress among the physicians our sales reps are calling on. This is a place we must show progress. Third, we will track the efficiency of our spending. How many dollars are we spending versus the uptake we see. This will be an important measure as we look to scale our launch quarter-by-quarter.

Now let's briefly talk about Libervant. We are excited to have out-licensed Libervant diazepam buccal film to Eton Pharmaceuticals. We have waited a long time for Libervant to be available to patients, and we expect this to finally come to fruition in 2027, if approved. We believe Eton is the right commercial team to launch Libervant, and we look forward to working with them in 2027 and beyond. While Libervant is not central to our growth story, it is an important product for patients and could also be an important cash contributor to the company.

Now let's turn to the pipeline. Long term, our goal is to become the leading provider of cutting-edge medications for patients who need to control their immune responses. We intend to do this through not only becoming a full-fledged commercial organization with deep expertise in allergy, dermatology and pulmonology, but also through building a new pipeline of development assets. We see 2027 as a pivotal year for our AdrenaVerse pipeline. In 2027, we would like to provide meaningful clinical data on AQST-108 for atopic dermatitis as well as bring additional AdrenaVerse-driven indications through proof of concept, utilizing our library of epinephrine prodrugs.

Now that our development team has resubmitted the Anaphylm application in the U.S., we expect to focus more energy on these efforts. So if you look at where we're going, there's a lot to be excited about. We are only a few months away from our FDA goal date for Anaphylm. We are expanding into ex-U.S. territories. We have managed our cash tightly and remain on track to fund Anaphylm's launch, if approved, and we will have more focus on our pipeline as we move into 2027. With that, I will turn the call over to Ernie.

Ernie Toth

Thank you, Dan, and good morning, everyone. By now, you will have seen our third quarter 2026 financial results in the earnings release issued last evening and detailed in our Form 10-Q. As we typically do, we will address most of the detailed discussion during our Q&A. I will focus my remarks on our financial performance, operating expenses and the disciplined capital allocation that supports our next phase of execution.

As Dan outlined, we continue to execute against the commitments we made at the beginning of the year. We resubmitted the Anaphylm application before the end of the third quarter. We completed the Libervant licensing transaction. We refinanced our debt in May before scheduled principal payments under the prior notes would have begun. And through disciplined management of our spending and liquidity, we now expect to end 2026 with more than $70 million in cash and cash equivalents.

We believe our existing liquidity, together with potential access to additional capital under the RTW and Oaktree agreements if Anaphylm is approved and other applicable conditions are satisfied, positions us to support launch readiness and initial commercialization activities for Anaphylm, if approved, while continuing to advance our pipeline. Before turning to the quarter, I want to briefly highlight the financial aspects of our recently announced Libervant transaction with Eton Pharmaceuticals.

Under the agreement, Eton received exclusive U.S. rights to commercialize Libervant, subject to applicable regulatory approvals. We received a $10 million upfront payment and are eligible to receive up to an additional $47.5 million in contingent regulatory and commercial milestone payments. We will also receive a mid-teens royalty on annual U.S. net sales of Libervant. Importantly, Aquestive will remain the exclusive manufacturer and supplier of Libervant to Eton under a long-term supply agreement.

So in addition to the upfront payment, potential milestones and royalties, the transaction preserves an ongoing manufacturing relationship around the product. We believe this is a capital-efficient structure for Aquestive. It places responsibility for U.S. commercialization with Eton while allowing us to participate in the product's future value and remain focused on our primary commercial priority, the potential launch of Anaphylm.

Now let me begin with revenue. Total revenue was $7.6 million in the third quarter of 2026 compared with $12.8 million in the third quarter of 2025. This decrease was primarily driven by the quarterly fluctuation of Suboxone product orders. Manufacture and supply revenue was $6.7 million in the third quarter compared with $11.5 million in the prior year period. This primarily reflects lower Suboxone revenue, partially offset by higher Ondif revenue. License and royalty revenue was $0.8 million in the third quarter compared to $1 million in the third quarter of 2025, primarily reflecting lower royalty revenue received during the period. Co-development and research fees were approximately $0.1 million compared with approximately $0.3 million in the prior period.

For the first 9 months of 2026, total revenue increased 14% to $35.8 million compared with $31.5 million for the same period in 2025. This increase was primarily driven by higher license and royalty revenue, including $5 million of Zevra-related royalty revenue, partially offset by lower manufacturing and supply revenue and lower co-development and research fees. Manufacture and supply revenue for the first 9 months was $27.4 million compared with $28.2 million in the prior year period. License and royalty revenue increased to $7.5 million from $2.7 million, primarily due to royalty revenue from Zevra.

Turning to operating expenses. Our results reflect the deliberate choices we have made as we prepare for a potential Anaphylm launch while continuing to manage our overall spending carefully. Research and development expenses were $4.3 million in the third quarter compared with $4.5 million in the third quarter of 2025. This decrease primarily reflects lower share-based compensation, partially offset by higher clinical trial costs associated with the human factors validation study and the pharmacokinetic study completed for the Anaphylm NDA resubmission. For the first 9 months of 2026, research and development expenses decreased $12.4 million from $14 million in the prior year period. This decrease primarily reflects lower product research expenses associated with the Anaphylm program and lower share-based compensation, partially offset by higher personnel costs.

Selling, general and administrative expenses were $14.2 million in the third quarter compared with $15.3 million in the prior year period. The year-over-year decrease primarily reflects approximately $1.5 million of lower legal fees, approximately $1.4 million of lower commercial spending and approximately $0.6 million of lower Anaphylm-related regulatory expenses. These decreases were partially offset by higher personnel costs, share-based compensation and consulting and outside services expenses.

For the first 9 months of 2026, selling, general and administrative expenses decreased to $39.2 million from $47 million in the first 9 months of 2025. The decrease primarily reflects approximately $6.1 million of lower commercial spending, the absence of the $4.3 million onetime Anaphylm PDUFA fee incurred in the prior year period, approximately $2.8 million of lower legal fees, approximately $1.5 million of lower regulatory and licensing fees related to Libervant and approximately $1 million of lower Anaphylm-related regulatory expenses. These decreases were partially offset by higher personnel costs, severance costs, share-based compensation and consulting and outside services expenses.

Turning to the bottom line. Our net loss for the third quarter of 2026 was $16.5 million or $0.13 per basic and diluted share. This compares with a net loss of $15.4 million or $0.14 per basic and diluted share in the third quarter of 2025. For the first 9 months of 2026, our net loss was $47.4 million or $0.38 per basic and diluted share compared with a net loss of $51.9 million or $0.51 per basic and diluted share for the same period in 2025. Just a reminder, the 2026 year-to-date results include a onetime loss on the extinguishment of debt of $11.7 million related to the repayment of our 13.5% notes. Excluding that onetime item, our net loss for the first 9 months of 2026 was $35.7 million.

Non-GAAP adjusted EBITDA loss was $12.2 million in the third quarter of 2026 compared with a non-GAAP adjusted EBITDA loss of $8.6 million in the third quarter of 2025. For the first 9 months of 2026, non-GAAP adjusted EBITDA loss narrowed to $19.2 million compared with a non-GAAP adjusted EBITDA loss of $35.5 million in the prior year period. Please refer to the reconciliation of net loss to non-GAAP adjusted EBITDA loss included in our earnings release.

Let me finish with liquidity and capital allocation. We had $90.3 million in cash and cash equivalents at September 30, 2026. This amount does not include the $10 million upfront license fee received from Eton in October in connection with the Libervant transaction. As Dan noted, we have managed our cash tightly and expect to finish 2026 with more than $70 million in cash and cash equivalents. This expectation includes the $10 million Eton upfront license fee received in October and does not assume receipt of the contingent RTW or Oaktree funding.

If Anaphylm receives FDA approval by the applicable deadline and we satisfy the other conditions under the relevant agreements, we expect to have access to $75 million under the RTW strategic funding agreement and an additional $20 million under the Oaktree term loan facility. Together with our existing liquidity, we believe these sources would support launch preparation and initial commercialization activities for Anaphylm, if approved, while allowing selective investment in our development pipeline.

We are maintaining our full year 2026 financial guidance. For 2026, the company continues to expect total revenue of $46 million to $50 million and non-GAAP adjusted EBITDA loss of $35 million to $30 million.

Looking ahead, our capital allocation priorities are clear. First, we will fund the activities necessary to maintain launch readiness and prepare for the potential U.S. commercialization of Anaphylm if approved. Second, we will continue to support the medical, regulatory, market access and payer work needed to prepare for commercialization following potential approval and to advance our regulatory strategy outside the United States. Third, we will invest selectively in the AdrenaVerse pipeline with an emphasis on the programs that we believe have the potential to generate meaningful clinical data and create long-term value. And finally, we will continue to manage our liquidity and capital carefully as we advance these priorities.

With that, I will now turn the call back to the operator to open the line for questions.

Operator

[Operator Instructions] Our first question comes from the line of Roanna Ruiz of Leerink Partners.

Phần hỏi đáp

Roanna Clarissa Ruiz

So a couple for me. First is with the upcoming PDUFA for Anaphylm, could you give us an update of what commercial initiatives you plan to use out of the gate? And generally, what the overall split could be between digital advertising, prescriber targeting and other field rep initiatives?

Daniel Barber

Sure. Roanna, did you have a second question or that was the question you wanted to put out?

Roanna Clarissa Ruiz

That was the first one. The second one, I did have a question about pre-approval info exchange with the PBMs. How much does that sort of coverage discussions? And can you give us a little color around that?

Daniel Barber

Sure. Absolutely. I appreciate that you instantly went to, of course, where our focus is on the commercial launch. Look, we feel great right now. We feel like we've managed our cash. We've got a strong cash position. We've maintained guidance. We're under review. Sherry and her team are preparing for launch. So you're absolutely right that the commercial initiatives are a place of focus. And Sherry is right here with me, and I'll let her walk you through the digital advertising and sales thoughts she has.

Sherry Korczynski

Thanks again for the question. We're so excited here. When you think about it, never has a product offered what Anaphylm will offer to both the allergist community as well as the caregivers and patients. It's truly a 360-degree approach to anaphylaxis management that has never been done before. And so it is critically important for us as we are completing the build of our senior staff, our district sales managers, our sales training, our supply chain is all ready to go. And as you know, it's based in the U.S. We are working diligently to prepare for the sales force and those nonpersonal promotion efforts.

While I'm not going to get into the details as far as percent of split as far as spend, as we've mentioned before, the allergists are key, and we will have approximately 75 representatives calling on around 8,000 customers. These are the top-tier allergists, some pediatricians and otolaryngologists. So we know and absolutely believe that surround -- having surround sound with those key customer targets is very, very important. So not only will our sales representatives be addressing, our medical colleagues are out at conferences, and they will continue to be out and with the allergists to continue to drive our message around our clinical efficacy as well as the other key benefits of the product. Being -- it's so easy to carry, it's very easy to use.

So you will see a nice split, Roanna, amongst the marketing initiatives and those sales force initiatives. If the deep question is really, are we going to be launching into TV and things like that, there will be a time and a place for major DTC efforts. As Dan has mentioned, we plan to be efficient with our spend. And as we see those opportunities, we'll begin to invest further.

Daniel Barber

So let me -- Roanna, take the second question, which was around the pre-approval PBM interactions. These are -- and what I believe your question was what's the extent of what you can do there. These are really important engagements and tying into what Sherry just outlined, we feel very strongly that the opportunity in this space is to bring health care providers and patients back to the clinical data. The auto-injector has been the de facto leader for 45 years because it's the only thing out there, not because the data is the reason for that product.

So we have an opportunity in our pre-approval interactions with the PBMs to show them our data. And I'm very fortunate to work with a great team, including Melina Cioffi and Dr. Matt Greenhawt, who are here with me this morning, who will walk that clinical data with our PBMs and really show them why we think we're differentiated. So we're not -- we understand that the dance to get to contracting is a difficult one for any pharmaceutical company. However, we do believe that, that clinical data can lead the way for us as we move forward.

Operator

Our next question comes from the line of Kristen Kluska of Cantor Fitzgerald.

Kristen Kluska

Congrats on the resubmission acceptance. Two questions for me. The first is when you received that acceptance, did you get any word or comments about whether the FDA would kind of be reviewing everything from scratch or really the key focus is on the new data and information that you've shared since? And then the second question is, I'm just curious, this past year has given you more time and you've obviously collected more data as a company. What would you say has changed the most in terms of your expectations on what this launch or product could look like versus where you were at a year before you had done these additional studies and work?

Daniel Barber

Thanks, Kristen. So in terms of the acceptance -- I'll turn it over to Melina in a second, and she can walk you through her thoughts. I will say this with the FDA. We've obviously been -- we think appropriately vocal is the way I would put it, that this is a pretty limited package. And we believe there's an opportunity, especially with where the FDA is publicly talking about speed of review and transparency and all of the things they want to do. We do believe there's an opportunity for a faster review here. We don't control that. So that's completely up to them. But I want to make sure everyone knows that we are advocating for that and doing it appropriately, we believe. But I'll let Melina give you her thoughts.

Melina Cioffi

Sure. So in terms of the focus of the review in the context of a resubmission, the focus is simply the complete response items that were outlined in the complete response letter. So when we hear from the agency in terms of the acceptance of the submission, they are informing us that our response is complete to facilitate their review. And the focus of that review will be strictly or intended to be strictly on the resubmission scope. So I hope that gives a little bit of clarity in terms of the scope of the data that will be reviewed consistent with what Dan had mentioned.

Daniel Barber

Thanks, Melina. So I will let Sherry give you some thoughts on learnings in a second here, but I just want to give in my mind, what I think is the most important learning and I'll go back to Dr. Matt Greenhawt joining us in February. And I don't know that this is due necessarily to having to deal with the packaging CRL that we're having to deal with, but more from what's important to allergists. And I think Matt has really championed in our company that the clinical data we have is really compelling.

And so that's why you've heard us, if you go back through what we talk about on these calls over the last 4 to 6 quarters, we've really moved from this idea of, okay, we have interesting PK comparison data to let's really talk about the pharmacodynamic data and what it means to patients. And you heard in my prepared remarks, we really do understand and believe the only thing a patient cares about is that their severe allergic reaction stops. And that is about the pharmacodynamic measures that we have, not necessarily PK comparisons. But I know Sherry has a lot of thoughts as well, so I'll let her add on hers.

Sherry Korczynski

No. Just to really add on to Dan is what has changed the most in the last year, Kristen. What I would say is with bringing Matt on and really like having great deep understanding of this PD data, we have so much confidence in the differentiation Anaphylm has for patients and caregivers. And so what I would say is we have to lean into the importance of trust and confidence. And so one of the key learnings that we've had is do patients feel that they have to carry multiple devices. Some do. Are physicians really confident in the data of the other -- the newer products.

And so for us, our ability to lean into the data into having physicians and caregivers, patients alike trust and be confident that Anaphylm is going to work in an emergency rescue situation. That is first and foremost. Look, the fact that we can carry it on the back of our phones, that it is very durable, that it's easy to use, that's all icing on the cake. We really truly believe that Anaphylm delivers confidence. It's carried differently. So I would say, overall, that is our biggest learning in the last year, Kristen.

Operator

Our next question comes from the line of David Amsellem of Piper Sandler.

David Amsellem

So two for me. First, in terms of the commercial launch and also your access initiatives, can you talk about what you're going to do differently relative to ARS and its experience with neffy, both in terms of physician targeting, promotion and access strategy. I'd love to hear how you're taking learnings from their experience and applying it to Anaphylm. So that's number one.

And then secondly, on the AdrenaVerse platform, I know that you've talked about being judicious about spend on the programs here. But as you think about atopic derm and that development program, -- can you give us a little insight into what other potential indications you can see yourself moving into for the platform and what you're going to prioritize over time beyond AD?

Daniel Barber

Thanks, David. Great to hear your voice. So I would say -- and I'm going to hand it over to Sherry in a second here to talk about targeting and promotion in particular. I would say the focus as a global comment, the focus that we'll bring of where the place to start our story in this community is probably the #1 thing that compared to anyone who's come out in the past years, you'll see from us. But I'll let Sherry give you her thoughts.

Sherry Korczynski

David, yes, thanks so much for the question. As it relates to -- we've discussed a lot about what our learnings over time from the device, the nasal device launch. What I will share again is our strategy is around depth in the allergists and high prescribing epinephrine writers community. And so we are going with a very targeted approach at about 8,000 to 8,500 key targets. And our sales team will be very focused on all the execution. Seeing the right targets with the right frequency and providing them with the right resources in order for them to have the confidence that Anaphylm will work in a rescue situation and a patient, quite frankly, will have it on them in the event that such a situation occurs. So I do see that as our launch as compared to the other launch, that is a difference.

From a promotion perspective, we talk about, again, we have a -- our value proposition is not based around just one thing. It is not a singular value prop. Our value prop is focused on efficacy to drive trust and confidence for the prescriber and their patients and caregivers. It's around the ease of carring and always having with you should an allergic reaction occur and then the ease of use and durability of the product. So we do believe from a promotion perspective that all of our promotional materials, our NPP, our -- the work that we're going to be -- that we're doing currently in marketing for the rest to have and promotions are all going to be tied around this value proposition.

And as it relates to the payers, as Dan mentioned, look, we want as many patients to have access to Anaphylm, and it's a top priority for us. Obviously, rapid payer coverage is key, managing the friction at our HCP offices is very important. And so we continue to have very robust discussions with the payers and the PBMs who continue to tell us there's significant interest in Anaphylm. It's important to us to look at this holistically and set up a best-in-class hub and patient support service strategy. And all of that work, David, is underway. We have the luxury, if you would say, of time. And so our team has picked apart every piece of this launch and so that we are very well prepared when the approval comes.

Daniel Barber

So I just, David, want to circle a little bit more on the market access piece of this. And I'll say something that perhaps the cynics in our industry wouldn't buy into. But I do believe from my interactions with the PBMs, I do believe they want to allow innovative products to be in the hands of the patients that they support from a payer perspective. They do want that, but they have a job to do. They have something that they're trying to manage, and that's the cost of the medical and health care community.

So while we may not agree on exactly how to approach any particular product, when you're going to a PBM and you're saying you have an innovation and you're asking for a premium to a generic auto-injector, you have to tell them why. You have to tell them why your product should be in that category. And that, again, is where we really believe the clinical data and talking about how that clinical data manifests itself in the community is an important factor in our market access story. So we'll continue those conversations and look forward to seeing how they unfold.

David Amsellem

And then the AdrenaVerse question?

Daniel Barber

I even wrote it down, and I forgot to address it. So my apologies. Yes, we're really excited about the long-term potential of the epinephrine platform. It's been frustrating, quite frankly, especially with having to deal with the CRL that we haven't been able to more quickly focus on the AdrenaVerse while we get Anaphylm through the regulatory process. The atopic derm is an entry point in our mind. As you know, it's -- we started with alopecia areata. But when you look at dermatology, atopic derm is a typical spot with a new mechanism of action or a new way of approaching something that you get into a space.

So we will, again, continue to show with our atopic derm products that in 2027, we can show real proof-of-concept data that people can buy into. We also think outside of dermatology that there are some really interesting indications, one that I know is near and dear to Dr. Matt Greenhawt's heart. We're not prepared today to say what that is, but we are working on it and look forward to hopefully bringing it forward in 2027.

Operator

Our next question comes from the line of François Brisebois of LifeSci Capital.

François Brisebois

I just wanted to actually go into more detail, if that's okay, on a prior question because when you talk about what the learnings of the last year and how to differentiate, it seems like there's a strong emphasis now from the PK to now PD side of things. Can you explain a little bit why you think that is more important? And how -- this is kind of a 3-part question. Like why do you think the PD is so important and so relevant? And then two, is that thought process appreciated? What's the evolution of the appreciation from the medical community, especially with Matt going around and speaking to people about this? Has that evolved for them in the past year as well? And yes, I guess just to start with that.

Daniel Barber

Sure. Well, and I'm going to pass it over to Matt, but I'll just say globally, I really do think that the simplest way to describe the concept is how fast can you stop a severe allergic reaction. And PD is obviously the first way to show that, but I'll let Matt pick it up from there.

Matthew Greenhawt

Yes, I mean, when you think about why do you give somebody epinephrine, they're having a reaction. They're starting to go into shock, showing other signs of hemodynamic distress. This is what epinephrine does. It abruptly raises your blood pressure and heart rate. And the speed of that response makes all the difference. As a clinician, that's really all I cared about every time I gave epinephrine to a patient. The blood levels are great. It's a regulatory point, but it really has limited clinical translation.

And what we're seeing and what we believe we have with our product is something that works fast and the resulting increases in heart rate and blood pressure are strong. And this difference is -- time is of the essence, and you really -- you want that to kick in as fast and as high as possible. That's how you get somebody out of danger. So I'm really excited. We have some data that we're going to present next week at the college meeting that better translates some of this from our OASIS study to show sort of really where that breakdown is of how if you focus too much on PK, you're really missing most of the story.

In terms of resonation in the field, this resonates well. This is, again, every clinician, this is what you want to hear, not what the PK is, but how fast this is going to work? How fast is my patient going to respond. That's a very tangible message. It's very approachable. I think the PK probably has been the harder thing for most of us to wrap our heads around for years and how long I've consulted and worked with the company going back to 2018, the Tmax story is great. And yes, we do -- PK, we certainly have great numbers on. Our Tmax is very fast and our Cmax is high.

But again, that's not what really matters to the patient. So I think we've been able to flip that message and either because of me or in spite of me, I think people are responding to it. And again, this was my area of expertise for years. And to hear it from me, I think with the work that I've done in anaphylaxis, I think, hopefully, it's helping. We'll see it.

François Brisebois

That's great. That's super helpful. And then can you just remind us how you compare to others on the PD side?

Matthew Greenhawt

Sure. Our Tmax, which is the timing of the peak of the heart rate and blood pressure is fast. Depending on the study, we're ranging between about 5 to 8 minutes depending on the blood pressure parameter depending on the study and then the heart rate response, 8 to 11 minutes. If you look in our 301 study, our 206 study for the comparators that we looked at, the earliest is the heart rate peak coming in at around 11 minutes and everything else is pushed out past 19 minutes.

Operator

Our next question comes from the line of Mazahir Alimohamed of Oppenheimer.

Unknown Analyst

This is Michael on for [indiscernible]. The first question is, could you share anything about the pricing relative to other auto-injectors and neffy and your expectations on formulary access in the first year? And would you be offering like cash pay or co-pay programs?

Daniel Barber

Sure. Thank you, Michael. So look, and this will be similar to what you heard me say in the August earnings call. We're obviously spending a lot of time on the market access piece of our launch, engaging in the allowable pre-approval interactions. In terms of how we're going to price the product, that is the one piece we're going to keep to ourselves for right now. I think there are obvious dynamics in the marketplace that people can assess and come to their own conclusion on.

In terms of expectations on formulary, look, any drug that is going to be launched, there are a variety of PBMs that need to believe in your story. You need to have arrangements and ability to contract with them, and we're going through that process. So as Sherry outlined before, when we get into 2027, how we're able to show progress on that front will be an important thing we bring to this forum.

In terms of the tools we'll use Sherry and her team, of course, we're going to have the typical tools for patients, whether it is, as Sherry mentioned, having a hub or it's allowing people to use co-pay cards, things like that, will, of course, be in our toolkit. The specifics and which ones we'll use and not use, we're not going to outline today. But I would say there's just typical things you do in a launch that you'll see us do, and I don't think that will be surprising to people.

Operator

Our next question comes from the line of Raghuram Selvaraju of H.C. Wainwright.

Raghuram Selvaraju

Firstly, with respect to Anaphylm, I was just wondering if maybe Sherry could comment on which specialist prescriber subpopulation is likely to be the most receptive kind of the earliest group of adopters, if you will, among the discrete groups of specialist prescribers that she mentioned in her prepared remarks. I also wanted to ask if the company could comment on the anticipated commercial receptivity for Libervant, which obviously is likely to be launched in the hands of your new partner, Eton.

But I wanted to see if you could comment perhaps on the degree to which the market is likely to be receptive to Libervant, in particular in the context of the other formulations and routes of administration for diazepam within the target indications for which Libervant is expected to be labeled.

And lastly, if you could comment on the degree to which you expect the commercial presence of Anaphylm and regulatory familiarity with the Anaphylm regulatory package to potentially provide you with any advantages going forward as you seek to develop and optimize the value of the AdrenaVerse platform?

Daniel Barber

Sure. Thanks, Ram. So I'll let Sherry first start on the prescriber piece.

Sherry Korczynski

Ram, thank you so much for the question. As we stated previously, we are focused on the allergist community, first and foremost. We will be calling on approximately 8,000 physicians with our 75 or so reps. Again, predominantly the allergists as they are the highest prescribers. And then from there, there are also pediatricians and otolaryngologists, ENTs that are high prescribers of epinephrine. Again, our launch is very focused. It is a big, big market. However, we, with our team, will be focused on that community.

Daniel Barber

Thanks, Sherry. So from a Libervant perspective, and Ram, you and I have known each other a long time. We've talked about Libervant for a number of years. This is a product that we feel very attached to here at Aquestive. So we think from a patient perspective, it's an important product. These -- the product, as you know, when approved, will be labeled for seizure clusters in the epilepsy space. This is a population that is in need of good solutions and solutions that will help them. So we're very excited to get it in the hands of patients and allow them to benefit from it.

Why Eton? We did have a multi-bidding situation. So we had other companies we could have gone with. What I think Eton has done well, if you follow their story is that just like us, where I opened in my prepared remarks today with, we're executing. We're hitting the things we said we would do. I think Eton is a company that does that as well. So in their launches, they've demonstrated they can put product into patients' hands in an effective way. We really like that. And I also like their culture. I like that they put patients at the center of what they're doing, and I think that bodes well with our culture. So we're very excited to see how that launch unfolds once approved in 2027.

From an AdrenaVerse perspective, your point is well taken. There's no doubt that as Melina and Matt and the team work through the FDA interactions as well as Melina, who's championing the ex-U.S. interactions, we learn more and more about Anaphylm epinephrine prodrugs and what the possibilities are. And also, we are making the regulatory bodies more comfortable with the prodrug approach. So I definitely would agree that as time goes on, the familiarity with that platform will only help us as we spread into other indications.

Operator

[Operator Instructions] Our next question comes from the line of Thomas Flaten of Lake Street Capital Markets.

Thomas Flaten

Just a follow-up on a previous question, Sherry, with respect to early adopters. How did you weight neffy prescribing in arriving at that target list of 8,000 to 8,500 prescribers? And then secondly, for Dan, has FDA communicated anything to you about a pre-approval inspection of your manufacturing facility?

Sherry Korczynski

Thank you so much for the question. Obviously, with the nasal device launch about 2 years ago at this time, it is a component of how we looked at the targeting for our sales representatives. The larger component is obviously the size, the amount of epinephrine that a physician prescribes on an annual basis. But of course, we did look at it and make considerations.

Daniel Barber

And Thomas, before I pass it over to Melina to talk about a potential PAI, just adding on to Sherry's thoughts. One thing I think that sometimes gets lost in the sauce in this space, we've done a lot of survey work, and I'm sure the other branded products in this space have as well. None of the surveys do we get information back from patients saying, we love auto-injectors, we want to keep them. So there is a big opportunity here, and we believe in that opportunity even more today than we did a year ago.

And when I watch Sherry and her team really think about how do we bring health care providers and patients into a world where they use a product like Anaphylm, these more innovative products, I think the position we have is compelling. It's going to take time, but the opportunity is there. But I'll let Melina talk about the PAI question.

Melina Cioffi

Sure. So in terms of inspection activity, we did go through first round the 10-month review interactions with the inspection group at FDA. And the focus was certainly on more of the routine clinical sites, which I recall us communicating previously. Here, there's a 6-month review time line. We know that the inspection activity is still possible, particularly from a clinical site perspective.

When it comes to the manufacturing plant, as you know, we have a U.S.-based manufacturing facility. It's supported over the years, not only products that are under review by the U.S. FDA, but certainly globally as well. We are well prepared for when and if the agency wants to come to our manufacturing site during this review.

Daniel Barber

And I'll just add on to Melina's point. Just remember, Thomas, from a manufacturing perspective, our base business remains steady and strong. In fact, on a year-to-date basis, Suboxone is actually up. It is a declining product over time. But year-over-year on a year-to-date basis, it's actually up. On [indiscernible] , it's growing nicely, and we'll have Libervant coming into the plant as well along with Anaphylm. So that part of our business remains important and strong.

Operator

I'm showing no further questions at this time. I would now like to turn it back to Dan Barber for closing remarks.

Daniel Barber

Thanks, Stephen. Thank you to everyone for joining us this morning. As you just heard, we continue to gain momentum as we rapidly approach our March 16 action date for Anaphylm. As Sherry outlined and Matt as well, the market opportunity remains compelling. We have the financing in place for our launch and our base business remains stable. So we look forward to keeping you updated on our launch progress over the next few months. And with that, we will close today's call.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.