Aquestive Therapeutics Inc (AQST) 2025 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Q3 2025 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 speaker today, Brian Korb. Please go ahead, sir.

您好，感謝您的耐心等待。歡迎參加 Aquestive Therapeutics Inc 2025 年第三季財報電話會議。（操作人員指示）請注意，今天的會議正在錄音。現在我謹將會議交給今天的演講嘉賓布萊恩·科布。請繼續，先生。

Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer; and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's recent business developments and performance for the third quarter of 2025, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Gary Slatko, Interim Chief Medical Officer; Sherry Korczynski, Chief Commercial Officer; Lori Braender, Chief Legal Officer; and Peter Boyd, Chief People Officer.

謝謝接線生。早上好，歡迎參加今天的電話會議。在今天的電話會議上，我將與執行長丹·巴伯和財務長厄尼·托斯一起，概述公司最近的業務發展和 2025 年第三季的業績，隨後進行問答環節。在問答環節，團隊成員將包括：臨時首席醫療官 Gary Slatko 博士；首席商務官 Sherry Korczynski；首席法律官 Lori Braender；以及首席人力資源官 Peter Boyd。

As a reminder, the company's remarks today corresponded with the earnings release that was issued after market close yesterday. In addition, a recording of today's call 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 2021 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 website.

提醒一下，該公司今天發表的聲明與昨天收盤後發布的盈利報告相符。此外，本次電話會議的錄音將在會議結束後不久發佈在 Aquestive 網站的投資者關係版塊中。提醒各位，Aquestive 團隊今天上午將討論一些非 GAAP 財務指標，作為其 2021 年第三季業績審查的一部分。這些措施的說明以及與 GAAP 的核對錶可以在昨天發布的盈利報告中找到，該報告已發佈在 Aquestive 網站的投資者關係部分。

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 other sections included in the company's annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed with the US Securities and Exchange Commission.

在電話會議期間，該公司將發表前瞻性聲明。我們在此提醒您注意公司在昨天發布的收益報告中概述的安全港條款，以及公司向美國證券交易委員會提交的年度報告（表格 10-K）、季度報告（表格 10-Q）和當前報告（表格 8-K）中的“風險因素”部分和其他部分所描述的影響公司的風險和不確定性。

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 its operations.

與任何一家正在研發候選產品和進行產品商業化的製藥公司一樣，該公司在業務、產品開發、監管審批和商業化以及與其營運相關的其他事項方面都存在重大風險和不確定性。

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 after the date of this conference call, whether as a result of new information, future events or otherwise, except as required under applicable law.

鑑於這些不確定因素，您不應過度依賴這些前瞻性陳述，這些陳述僅代表作出之日的觀點。實際結果可能與這些說法有重大差異。所有歸因於 Aquestive 或任何代表其行事的人的前瞻性聲明均受本警示性聲明和昨天發布的盈利公告中所包含的警示性聲明的完整限制。除適用法律另有規定外，本公司不承擔在本次電話會議日期之後更新其前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。

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

現在我想把電話交給丹。

Thanks, Brian. Good morning, everyone, and thank you for joining us today. This morning, we are holding our earnings call from the American College of Asthma, Allergy and Immunology Annual Conference here in Orlando, Florida. This is one of the largest allergy-focused conferences in the US, and we are proud to be here supporting the college at their annual gathering. We have almost 20 colleagues on site this week and a host of events, including multiple poster presentations, a fully staffed medical affairs booth on the exhibition floor and multiple engagements with investigators. This truly is an exciting week for the Aquestive team.

謝謝你，布萊恩。各位早安，感謝大家今天收看我們的節目。今天上午，我們將在佛羅裡達州奧蘭多舉行的美國氣喘、過敏和免疫學會年會上召開財報電話會議。這是美國規模最大的以過敏為主題的會議之一，我們很榮幸能在這裡支持學院的年度盛會。本週我們有近 20 位同事在現場，並舉辦了一系列活動，包括多場海報展示、展廳內配備齊全的醫療事務展位以及與研究人員的多次交流。對於Aquestive團隊來說，這真是令人興奮的一週。

This is also emblematic of the increased awareness of our Anaphylm dibutepinephrine Sublingual Film program within the allergy community. In fact, our latest data suggests most allergists are now aware of our sublingual film program and over 25% have even completed our continuous medical education, or CME presentation offered through Medscape, the leading provider of CME materials for physicians.

這也像徵著過敏群體對我們Anaphylm二丁腎上腺素舌下膜計畫的認識不斷提高。事實上，我們最新的數據顯示，大多數過敏科醫生現在都知道我們的舌下薄膜計劃，超過 25% 的過敏科醫生甚至完成了我們透過 Medscape（領先的醫生 CME 材料提供者）提供的繼續醫學教育 (CME) 課程。

As we approach our FDA scheduled action date of January 31 for Anaphylm, we are well positioned from an allergist awareness perspective. In case anyone hasn't been paying attention, Anaphylm, if approved by the FDA, will be the first and only oral medication for the treatment of severe allergic reactions including anaphylaxis. Today, health care providers, caregivers and patients must choose between two types of medical devices, auto-injectors and nasal sprays. We believe our portability, low barrier to use and fast absorption profile creates a transformational offering for the allergy community.

隨著 FDA 計劃於 1 月 31 日對 Anaphylm 採取行動的日期臨近，從提高過敏症專家的認知度來看，我們已經做好了充分的準備。如果有人還沒注意到的話，Anaphylm 如果獲得 FDA 批准，將成為第一種也是唯一一種用於治療嚴重過敏反應（包括過敏性休克）的口服藥物。如今，醫療保健提供者、護理人員和患者必須在兩種醫療器材之間做出選擇：自動注射器和鼻噴劑。我們相信，我們的產品具有便攜性、使用門檻低、吸收快等優點，能為過敏族群帶來變革性的產品。

Following our equity raise and strategic financing agreement that we announced this past August, our prelaunch activities have accelerated and remain on track for a first quarter 2026 launch if Anaphylm receives FDA approval. Our marketing materials are ready to go and are only awaiting a final label. We are in the process of hiring our district managers and will hire sales reps upon FDA approval. Our market access team is in full swing and interacting with payers under acceptable preapproval guidelines. Our supply chain is prepared to rapidly produce material once final labeling has been provided by the FDA. And importantly, our medical affairs team is fully deployed, as you heard from my opening statements, regarding this week conference. Simply put, we are ready to go.

繼我們今年 8 月宣布的股權融資和策略融資協議之後，我們的上市前準備工作已經加快，如果 Anaphylm 獲得 FDA 批准，預計將於 2026 年第一季上市。我們的行銷資料已經準備就緒，只等貼上最終標籤了。我們正在招募區域經理，待獲得FDA批准後將招募銷售代表。我們的市場准入團隊正在全力運作，並按照可接受的預先批准準則與付款方進行互動。一旦FDA提供最終標籤，我們的供應鏈將做好快速生產材料的準備。更重要的是，正如你們從我的開場白中聽到的那樣，我們的醫療事務團隊已全面部署，以應對本週的會議。簡而言之，我們已經準備就緒。

Now let's turn to the FDA. Given the government shutdown, we requested the FDA to provide us with a status update on the review timing of our filings. I am pleased to say that as of this last update, the FDA confirmed they are aiming for an on-time review of our application. As we reported to you in September, the FDA has informed us that we will not have an Advisory Committee meeting. However, we remain ready to provide further information if necessary to the FDA reviewers. We will keep everyone appropriately updated as we learn more and as we get closer to our action date.

現在讓我們來看看美國食品藥物管理局（FDA）。鑑於政府停擺，我們請求 FDA 向我們提供我們申請資料的審查時間的最新情況。我很高興地告訴大家，截至最新進展，FDA 已確認他們正努力按時審查我們的申請。正如我們在9月向您報告的那樣，FDA已經通知我們，我們將不會召開諮詢委員會會議。但是，如有必要，我們隨時準備向FDA審查人員提供更多資訊。隨著我們了解更多資訊以及行動日期的臨近，我們將及時向大家通報最新情況。

As we begin looking towards 2026, there are two very important priorities in our business, one, putting together the best possible launch of Anaphylm. And two, exploiting the science behind our Adrenaverse platform. If you recall, we made the strategic choice to slow down our Adrenaverse pipeline initiatives in the first half of 2025, while we work on fully funding our launch.

展望 2026 年，我們公司有兩個非常重要的優先事項，一是盡力推出 Anaphylm。第二，充分利用我們 Adrenaverse 平台背後的科學原理。如果您還記得的話，我們曾做出策略性選擇，在 2025 年上半年放緩 Adrenaverse 的研發管線計劃，同時努力籌集足夠的資金來啟動我們的產品。

Now it is time to get going. To better accomplish these goals, I announced several leadership changes earlier this week. First, to better support Anaphylm, I've asked Dr. Gary Slatko to become our interim Chief Medical Officer. Gary has the perfect blend of medical affairs expertise and deep understanding of our Anaphylm development program. Some of you may recall, Gary was previously our Chief Medical Officer from 2018 to 2023. I have also promoted Peter Boyd to Chief People Officer. This is a critical role as we expand our organization to include a full commercial team.

現在該出發了。為了更好地實現這些目標，我在本週稍早宣布了幾項領導層變動。首先，為了更好地支持 Anaphylm，我已經邀請 Gary Slatko 博士擔任我們的臨時首席醫療官。Gary 完美地融合了醫學事務的專業知識和對我們 Anaphylm 開發專案的深刻理解。你們當中有些可能還記得，Gary 曾在 2018 年至 2023 年擔任我們的首席醫療官。我還提拔了 Peter Boyd 為首席人力資源長。隨著我們擴大組織規模，組成完整的商業團隊，這是一個至關重要的職位。

On the Adrenaverse side, I am very excited to announce the addition of Dr. Matthew Davis as our Chief Development Officer. Matthew and his team will be very focused in 2026 on kick-starting our R&D efforts and driving clinical proof points that show the value our Adrenaverse platform can create. While Anaphylm is transformational to the allergy community and to Aquestive, it is just the beginning of our story. Through the efforts of Matthew and his team, I am confident there are multiple significant programs yet to come.

在 Adrenaverse 方面，我非常興奮地宣布 Matthew Davis 博士加入我們，擔任首席發展長。2026 年，Matthew 和他的團隊將非常專注於啟動我們的研發工作，並推動臨床驗證，以證明我們的 Adrenaverse 平台所能創造的價值。雖然 Anaphylm 對過敏群體和 Aquestive 來說具有變革性意義，但這只是我們故事的開始。我相信，在馬修和他的團隊的努力下，未來還會有許多重要的計畫陸續推出。

The first of these programs is our AQST-108 development program for the treatment of alopecia areata. We have completed the pre-IND meeting process with the FDA and we'll be submitting our IND shortly. We expect to be in the clinic with our next study, a safety study in men starting in January, and expect this study to complete rapidly. With the funding just received by the company, we will look to advance our progress on this front.

這些項目中的第一個是我們用於治療斑禿的 AQST-108 開發項目。我們已經完成了與FDA的IND前會議流程，我們將很快提交IND申請。我們預計將於 1 月開始進行下一項臨床研究，這是一項針對男性的安全研究，我們預計這項研究將很快完成。公司剛剛獲得了這筆資金，我們將努力推進這方面的工作。

Our international efforts for Anaphylm as well continue to gather steam. We had a positive interaction with Health Canada in the third quarter and are excited to share that no further studies are required for filing our application. We anticipate filing in Canada in the first half of 2026. We have also continued our interactions with the European Medicines Agency, or EMA, and expect to have full feedback regarding the application process by early in the first quarter of 2026. We will continue to advance our regulatory interactions as we work towards the appropriate partnerships in these territories.

我們在國際上為Anaphylm所做的努力也不斷取得進展。我們在第三季與加拿大衛生部進行了積極的溝通，很高興地宣布，提交申請無需進行進一步的研究。我們預計將於 2026 年上半年在加拿大提交申請。我們也繼續與歐洲藥品管理局（EMA）互動，並預計在 2026 年第一季初獲得有關申請流程的全面回饋。我們將繼續推進與監管機構的互動，並努力在這些地區建立合適的合作關係。

Our base business continues to be an important provider of cash flow and capabilities and we expect this to continue in 2026. We continue to see stable demand from Indivior, our largest base customer. We have also seen significant growth in our South American partnership focused on the Brazilian market. Our manufacturing team is prepared to take a leading role in supply of Anaphylm to our commercial team and eventually around the world.

我們的基礎業務仍然是現金流和能力的重要來源，我們預計這種情況在 2026 年將持續下去。我們持續看到來自我們最大客戶 Indivior 的穩定需求。我們在南美地區的合作夥伴關係也取得了顯著成長，尤其以巴西市場為重點。我們的生產團隊已做好準備，在向我們的商業團隊乃至全世界供應 Anaphylm 方面發揮主導作用。

Finally, from a financing perspective, we are now well positioned to fully fund our business through the commercial launch of Anaphylm, if approved by the FDA. As Ernie will discuss with you in a moment, one of the last pieces to the puzzle in locking in our finances is refinancing our existing debt. We are well on our way with this effort. And as of today, I expect this to close before the end of the year.

最後，從融資角度來看，如果Anaphylm獲得FDA批准，我們現在完全有能力為我們的業務提供充足的資金，直到其商業化上市。正如厄尼稍後將與你們討論的那樣，鎖定我們財務狀況的最後一塊拼圖之一就是對我們現有的債務進行再融資。我們在這項工作中進展順利。截至目前，我預計該專案將在年底前完成。

So to summarize, as we look forward, you should expect the following. We will be ready to launch in the first quarter if Anaphylm is approved on time by the FDA. We will begin to make rapid progress on our broader Adrenaverse platform and advance our pipeline. We will continue to actively progress our regulatory applications for Anaphylm outside the US. And our base business along with our financing from August have us financially well positioned for 2026 and beyond.

總而言之，展望未來，您應該期待以下幾點。如果Anaphylm能按時獲得FDA批准，我們將在第一季做好上市準備。我們將開始在更廣泛的 Adrenaverse 平台上取得快速進展，並推動我們的產品線。我們將繼續積極推動Anaphylm在美國以外的監管申請。加上我們8月份獲得的融資，我們的基礎業務使我們在2026年及以後擁有了良好的財務狀況。

Now I will turn the call over to Ernie.

現在我把電話交給厄尼。

Thank you, Dan, and good morning, everyone. By now, you have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the third quarter 2025 results into Q&A.

謝謝你，丹，大家早安。想必各位已經看到了我們昨晚發布的盈利報告中的財務業績。按照慣例，我們將把與 2025 年第三季業績相關的大部分討論放在問答環節進行。

During the third quarter, we continued to execute on our strategy to support the continued development of Anaphylm, our lead epinephrine product candidate that has no needle, is not a device, is orally administered and is easy to carry. This includes the completion of the pediatric trial and supporting pre-approval launch activities for Anaphylm to increase awareness among physicians, payers and the advocacy community as we approach the PDUFA action date scheduled for January 31, 2026.

第三季度，我們繼續執行我們的策略，以支持我們領先的腎上腺素候選產品 Anaphylm 的持續開發。該產品無需針頭，不是器械，可口服，且易於攜帶。這包括完成兒科試驗，並支持 Anaphylm 的上市前審批活動，以提高醫生、支付方和倡導團體對該產品認識，因為我們即將迎來定於 2026 年 1 月 31 日的 PDUFA 審批日期。

To support the Anaphylm launch, we completed two financings during the third quarter. First, we completed an equity raise for $85 million, led by RTW Investments and included participation from Samsara BioCapital, EcoR1 Capital, Perceptive Advisors, Sio Capital Management, Capital Management and Nantahala Capital.

為了支持 Anaphylm 的上市，我們在第三季完成了兩筆融資。首先，我們完成了 8,500 萬美元的股權融資，由 RTW Investments 領投，Samsara BioCapital、EcoR1 Capital、Perceptive Advisors、Sio Capital Management、Capital Management 和 Nantahala Capital 也參與其中。

Secondly, we completed a commercial launch financing of $75 million with RTW Investments that is subject to FDA approval of Anaphylm and satisfaction of certain refinancing and other customary conditions related to the company's existing debt. Under the terms of the agreement, RTW will receive a tiered single-digit percentage of annual net sales of Anaphylm in the US for the treatment of type one allergic reactions including anaphylaxis, subject to a stated cap.

其次，我們與 RTW Investments 完成了 7,500 萬美元的商業啟動融資，但前提是 Anaphylm 獲得 FDA 批准，並且滿足與公司現有債務相關的某些再融資和其他慣例條件。根據協議條款，RTW 將獲得 Anaphylm 在美國用於治療 I 型過敏反應（包括過敏性休克）的年度淨銷售額的個位數百分比分成，但須遵守規定的上限。

These two financings provide critical capital that will support the company through 2027, enabling us to successfully bring Anaphylm to market if approved by the FDA and delivering new treatment option for patients in need. As required by the commercial launch financing, we are pursuing a refinancing of our existing debt. We have found the debt capital markets to be robust for our financing and hope to be in a position to announce a new debt partner in the near future.

這兩筆融資提供了關鍵資金，將支持公司發展到 2027 年，使我們能夠在獲得 FDA 批准後成功地將 Anaphylm 推向市場，並為有需要的患者提供新的治療選擇。根據商業啟動融資的要求，我們正在對現有債務進行再融資。我們發現債務資本市場對我們的融資非常有利，並希望在不久的將來能夠宣布新的債務合作夥伴。

Aquestive's manufacturing business remains steady with a gradual decline of our licensee products, Suboxone, which accounts for the substantial part of our current operating revenue, being offset by growth across newer collaborations, including for the licensed products Ondif and Sympazan. In addition, the company being a US-based manufacturer with intellectual property domiciled in the US has a supply chain, which currently remains largely unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production and global distribution for the near term.

儘管我們授權產品 Suboxone 的銷量逐漸下降（Suboxone 占我們當前營業收入的很大一部分），但 Aquestive 的製造業務依然保持穩定，不過，包括授權產品 Ondif 和 Sympazan 在內的新合作項目的增長抵消了這一影響。此外，該公司是一家總部位於美國的製造商，其智慧財產權也位於美國，其供應鏈目前基本上未受已實施和擬議關稅的影響，從而在短期內為生產和全球分銷提供了持續的可靠性和穩定性。

Now let's turn to the third quarter results. Excluding the impact of onetime recognition of deferred revenue in the third quarter of 2024, total revenues increased by $0.5 million or 4% year-over-year to $12.8 million in the third quarter of 2025. As a reminder, the onetime recognition of deferred revenue in the prior year was due to the termination of a licensing and supply agreement.

現在我們來看第三季業績。不計入 2024 年第三季一次性確認遞延收入的影響，2025 年第三季總營收年增 50 萬美元，增幅為 4%，達到 1,280 萬美元。需要說明的是，上一年一次性確認的遞延收入是由於許可和供應協議的終止所致。

Including the deferred revenue recognized in the prior year, total revenues decreased to $12.8 million in the third quarter 2025 from $13.5 million in the third quarter of 2024. Manufacturer and supply revenue increased to $11.5 million in the third quarter of 2025 from $10.7 million in the third quarter 2024, primarily due to increases in Sympazan and Suboxone revenues.

計入上一年確認的遞延收入，2025 年第三季總收入從 2024 年第三季的 1,350 萬美元減少至 1,280 萬美元。2025 年第三季度，製造商和供應收入從 2024 年第三季的 1,070 萬美元增至 1,150 萬美元，主要原因是 Sympazan 和 Suboxone 的收入增加。

Total revenues decreased to $31.5 million for the nine months ended September 30, 2025, from $45.7 million for the nine months ended September 30, 2024, due to onetime recognition of deferred revenue in the prior year. Excluding this onetime recognition of deferred revenue, total revenues decreased by $2.6 million or 8% year-over-year. Manufacturer and supply revenue decreased to $28.2 million for the nine months ended September 30, 2025, from $29.3 million for the nine months ended September 30, 2024, primarily due to decreases in Suboxone revenues, partially offset by increases in Ondif revenues. Research and development expenses decreased to $4.5 million in the third quarter of 2025 from $5.3 million in the third quarter of 2024. The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the Anaphylm program, partially offset by increases in share-based compensation.

截至 2025 年 9 月 30 日的九個月，總收入從截至 2024 年 9 月 30 日的九個月的 4,570 萬美元減少至 3,150 萬美元，原因是上一年一次性確認了遞延收入。不計入這筆一次性確認的遞延收入，總收入年減 260 萬美元，降幅為 8%。截至 2025 年 9 月 30 日的九個月，製造商和供應收入從截至 2024 年 9 月 30 日的九個月的 2930 萬美元減少到 2820 萬美元，主要原因是 Suboxone 收入減少，但 Ondif 收入增加部分抵消了這一減少。2025 年第三季研發費用從 2024 年第三季的 530 萬美元減少到 450 萬美元。研發費用的減少主要是由於與 Anaphylm 專案相關的臨床試驗成本降低，但部分被股權激勵的增加所抵消。

Research and development expenses decreased to $14 million for the nine months ended September 30, 2025, from $15.4 million for the nine months ended September 30, 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial costs associated with the Anaphylm program, partially offset by increases in share-based compensation, increases in product research expenses and increases in personnel costs.

截至 2025 年 9 月 30 日的九個月，研發費用減少至 1,400 萬美元，截至 2024 年 9 月 30 日的九個月，研發費用為 1,540 萬美元。研發費用的減少主要是由於與 Anaphylm 計畫相關的臨床試驗成本的減少，但部分被股權激勵增加、產品研發費用增加和人員成本增加所抵消。

Selling, general and administrative expenses increased to $15.3 million in the third quarter of 2025 from $12.1 million in the third quarter of 2024. The increase primarily represents higher pre-commercial spending of approximately $1.8 million, higher legal fees of approximately $1 million, higher regulatory expenses related to Anaphylm of approximately $0.6 million, higher personnel costs of approximately $0.2 million, higher share-based compensation expenses of approximately $0.2 million, partially offset by lower regulatory and licensing fees of $0.5 million and lower consulting fees of approximately $0.2 million.

2025 年第三季銷售、一般及行政費用從 2024 年第三季的 1,210 萬美元增加到 1,530 萬美元。此次成長主要體現在商業化前支出增加約 180 萬美元、法律費用增加約 100 萬美元、與 Anaphylm 相關的監管費用增加約 60 萬美元、人員成本增加約 20 萬美元、股權激勵費用增加約 20 萬美元，部分被監管和許可費用減少 50 萬美元以及諮詢費用減少約 20 萬美元所抵消。

Selling, general and administrative expenses increased to $47 million for the nine months ended September 30, 2025, from $34.2 million for the nine months ended September 30, 2024. The increase primarily represents higher commercial spending on prelaunch activities for Anaphylm of approximately $6 million, higher regulatory fees related to the Anaphylm PDUFA fee of approximately $4.3 million, higher personnel costs of approximately $1.1 million, higher regulatory expenses related to Anaphylm of approximately $1 million, higher share-based compensation expenses of approximately $0.7 million, higher legal fees of approximately $0.6 million and higher regulatory and licensing fees of approximately $0.6 million, partially offset by decreases in severance costs of approximately $1.1 million and lower insurance expenses of approximately $0.6 million.

截至 2025 年 9 月 30 日的九個月，銷售、一般及行政費用增加至 4,700 萬美元，而截至 2024 年 9 月 30 日的九個月為 3,420 萬美元。此次成長主要體現在 Anaphylm 上市前活動的商業支出增加約 600 萬美元、與 Anaphylm PDUFA 費用相關的監管費用增加約 430 萬美元、人員成本增加約 110 萬美元、與 Anaphylm 相關的監管費用增加約 100 萬美元、股份支付費用增加約 70 萬美元、監管費用110 萬美元和保險費用減少約 60 萬美元所抵銷。

Aquestive's net loss for the third quarter of 2025 was $15.4 million or $0.14 for both basic and diluted loss per share compared to the net loss in the third quarter of 2024, of $11.5 million or $0.13 for both basic and diluted loss per share. Excluding the impact of onetime recognition of deferred revenue, the net loss in the third quarter 2024 was $12.7 million. Aquestive net loss for the nine months ended September 30, 2025, was $51.9 million or $0.51 for both basic and diluted loss per share compared to the net loss for the nine months ended September 30, 2024 of $27.1 million or $0.32 for both basic and diluted loss per share. Excluding the impact of onetime recognition of deferred revenue, the net loss for the nine months ended September 30, 2024 was $38.6 million.

Aquestive 2025 年第三季淨虧損 1,540 萬美元，即每股基本虧損及每股攤薄虧損均為 0.14 美元，而 2024 年第三季淨虧損為 1,150 萬美元，即每股基本虧損及每股攤薄虧損均為 0.13 美元。不計入一次性確認遞延收入的影響，2024 年第三季淨虧損為 1,270 萬美元。截至 2025 年 9 月 30 日的九個月，Aquestive 淨虧損為 5,190 萬美元，即每股基本虧損和每股攤薄虧損均為 0.51 美元，而截至 2024 年 9 月 30 日的九個月淨虧損為 2,710 萬美元，即每股基本虧損和每股盈餘虧損 20.32 230.32 30.3000.32 美元。不計一次性確認遞延收入的影響，截至 2024 年 9 月 30 日的九個月淨虧損為 3,860 萬美元。

Non-GAAP adjusted EBITDA loss was $8.6 million in the third quarter of 2025 compared to non-GAAP adjusted EBITDA loss of $6.6 million in the third quarter of 2024. Excluding the impact of onetime recognition of deferred revenue, non-GAAP adjusted EBITDA in the third quarter 2024 was a loss of $7.8 million. Non-GAAP adjusted EBITDA loss was $35.5 million for the nine months ended September 30, 2025, compared to non-GAAP adjusted EBITDA loss of $11.9 million for the nine months ended September 30, 2024. Excluding the impact of onetime recognition of deferred revenue, non-GAAP adjusted EBITDA for the nine months ended September 30, 2024 was a loss of $23.4 million.

2025 年第三季非 GAAP 調整後 EBITDA 虧損為 860 萬美元，而 2024 年第三季非 GAAP 調整後 EBITDA 虧損為 660 萬美元。不計入一次性確認遞延收入的影響，2024 年第三季非 GAAP 調整後的 EBITDA 虧損 780 萬美元。截至 2025 年 9 月 30 日的九個月，非 GAAP 調整後的 EBITDA 虧損為 3,550 萬美元，而截至 2024 年 9 月 30 日的九個月，非 GAAP 調整後的 EBITDA 虧損為 1,190 萬美元。不計一次性確認遞延收入的影響，截至 2024 年 9 月 30 日的九個月的非 GAAP 調整 EBITDA 虧損 2,340 萬美元。

Cash and cash equivalents were $129.1 million as of September 30, 2025. Aquestive's full year 2025 financial guidance remains unchanged. The company expects total revenue of $44 million to $50 million and non-GAAP adjusted EBITDA loss of $47 million to $51 million. As a reminder, our revenue guidance for 2025 no longer includes revenue for Libervant for ARS patients aged between two and five years, and our 2024 revenue included onetime nonrecurring recognition of deferred revenue related to termination of certain licensing and supply agreements.

截至2025年9月30日，現金及現金等價物為1.291億美元。Aquestive 2025 年全年財務預期維持不變。該公司預計總收入為 4,400 萬美元至 5,000 萬美元，非 GAAP 調整後 EBITDA 虧損為 4,700 萬美元至 5,100 萬美元。再次提醒，我們 2025 年的收入預期不再包括 Libervant 對 2 至 5 歲 ARS 患者的收入，而我們 2024 年的收入包括與終止某些許可和供應協議相關的一次性非經常性遞延收入確認。

Our non-GAAP adjusted EBITDA loss guidance for 2025 include significant preapproval launch spending for Anaphylm, costs associated with the submission of the Anaphylm NDA and related filing fee, completion of the Anaphylm pediatric clinical trial and costs associated with the preparation for the potential Advisory Committee meeting that is no longer required by the FDA for approval of Anaphylm.

我們對 2025 年的非 GAAP 調整後 EBITDA 虧損預期包括 Anaphylm 獲批前的重大上市支出、與提交 Anaphylm NDA 及相關備案費相關的成本、完成 Anaphylm 兒科臨床試驗以及與準備潛在的諮詢委員會會議相關的成本（FDA 不再要求召開該會議以批准 Anaphylm 兒科臨床試驗以及與準備潛在的諮詢委員會會議相關的成本（FDA 不再要求召開該會議以批准 Anaphylm 兒科臨床試驗以及與準備潛在的諮詢委員會會議相關的成本（FDA 不再要求召開該會議以批准 Anaphylm 兒科臨床試驗以及與準備潛在的諮詢委員會會議相關的成本（FDA 不再要求召開該會議以批准 Anaphylm 兒科臨床試驗以及與準備潛在的諮詢委員會會議相關的成本（FDA 不再要求召開該會議以批准 Anaphylm）。

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

接下來，我將把線路交還給接線員，讓他接聽提問電話。

(Operator Instructions)

（操作說明）

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Just a couple for me. First, any new comments on your competitors' citizens petition and how that may or may not impact the timing of the FDA decision? And also, have you responded to the citizens petition? Just kind of latest thoughts there.

就我一個人用。首先，對於競爭對手發起的公民請願活動，您有什麼新的評論？該請願活動可能會或不會對 FDA 的決定時間產生什麼影響？另外，您是否已對市民請願書作出回應？只是我最近的想法。

And then secondly, I wanted to ask you about pricing and access just given whatever learnings you might have had from the experience of your competitor in its launch. How are you thinking about pricing relative to the nasal spray and the generic EpiPen? And also how does that play into your strategy on access? Yes.

其次，我想問您關於定價和存取方面的問題，因為您可能從競爭對手的產品發布經驗中學到了一些經驗教訓。您如何考慮相對於鼻噴劑和通用型EpiPen的定價？這又將如何影響你們的進入策略呢？是的。

David, so let me start in more general place and then I will come to your specific question. We're sitting here today with the team here in Orlando, Florida, the college, the ACAAI conference. What's exciting is everything is coming together. So if you look at the pieces and the parts of what we're trying to accomplish, what you're seeing today is how they're starting to intertwine. So the FDA review is in good shape. We'll talk about that in a minute with your comment.

大衛，那麼我先從更一般性的問題開始，然後再回答你具體的問題。今天我們和這支隊伍一起坐在佛羅裡達州奧蘭多的這所大學裡，參加ACAAI會議。令人興奮的是，一切都朝著好的方向發展。所以，如果你看看我們正在努力實現的目標的各個部分，你今天看到的就是它們開始交織在一起的樣子。所以FDA的審查進展順利。我們稍後會結合您的評論來討論這個問題。

Our financing is in place. The market grew by almost 9% last quarter. We've expanded our patent coverage. We're bringing in the right team. And our prelaunch activities, as I'm sure you'll hear from Sherry throughout the Q&A, are in great shape. So we're incredibly excited with where we are right now.

我們的資金已經到位。上個季度市場成長了近9%。我們擴大了專利覆蓋範圍。我們正在組建合適的團隊。正如雪莉在問答環節中所說，我們的發布前準備工作進展順利。所以，我們對目前所處的階段感到無比興奮。

Now so let's turn then -- let's take that excitement and let's turn it to the CP that our competitor put into the FDA, which you asked about. So think about -- and David, I don't know if you read all 16 pages of that document. But think about what it took to create that document. A very expensive DC-based law firm was hired. That law firm had to write the document, put it together, review it with the organization and then finalize it and send it to the FDA. And I will tell you that was a significant -- my belief is that was a significant amount of resources by our competitor, by the law firm and probably a big bill.

那麼，讓我們把這種興奮勁兒轉移到我們的競爭對手提交給 FDA 的 CP 上，也就是你問到的那個 CP 上。所以想想──還有，大衛，我不知道你有沒有讀過那份文件的全部16頁。但想想看，創建這份文件需要付出多少努力。我們聘請了一家位於華盛頓特區的收費非常昂貴的律師事務所。那家律師事務所必須撰寫這份文件，將其整理成冊，與相關機構進行審查，然後定稿並發送給 FDA。我可以告訴你，我認為這是我們的競爭對手，也就是那家律師事務所投入的大量資源，而且很可能是一筆巨額帳單。

So companies only do that if there's a reason to do it. I don't think they did it because they felt a civic duty to do it. I think they did it in my personal opinion because they're worried. Because they're worried about what we're bringing to the market and what it does to them. Now why should they worry? What can I focus on to say they should be worried?

所以公司只有在有理由的情況下才會這樣做。我不認為他們這樣做是出於公民義務感。我個人認為他們這樣做是因為他們感到擔心。因為他們擔心我們把產品推向市場會對他們造成什麼影響。他們為什麼要擔心呢？我應該著重於哪些方面才能讓他們感到擔憂？

If you look in the supplemental materials that we put out, you'll see that our latest survey work, and I'm sure they're doing their own survey work, shows that when you send a mockup, a nonpromotional version of the nasal spray and the film to a person who's familiar with this space and ask them what product they would prefer, in our survey, which was 35 individuals, 33 of them said they would prefer the film. One of them said they would prefer the nasal spray and one said that they were indifferent to whether it was the nasal spray or the film. So when I look at that and I look at why that CP was put in, that makes sense to me.

如果你查看我們發布的補充資料，你會發現我們最新的調查工作（我相信他們也在進行自己的調查工作）表明，當你把鼻噴劑和薄膜的樣品（非促銷版本）發送給熟悉這個領域的人，並詢問他們更喜歡哪種產品時，在我們的調查中（共有 35 人），有 33 人表示他們更喜歡薄膜。其中一人表示更喜歡鼻噴劑，另一人表示對鼻噴劑或薄膜無所謂。所以當我看到這一點，並思考為什麼會加入那個CP時，我覺得這很合理。

Now in terms of the content of the CP, we have taken the time -- it was definitely a kitchen sink approach so we have taken the time to unwind all of it and look at it. And in terms of our review of what they have put forward, it is factually incorrect in a variety of places and misinformed. We think that hurts the credibility with the FDA. And from our perspective, we've seen zero impact to our review and expect zero impact.

至於CP的內容，我們已經花時間——這絕對是一種包羅萬象的方法，所以我們花時間把所有內容都展開來仔細審視。就我們審查他們提出的內容而言，其中許多地方都存在事實錯誤和誤導性資訊。我們認為這會損害FDA的信譽。從我們的角度來看，我們的審核沒有受到任何影響，預計也不會受到任何影響。

So now let me turn to your second question, which was on pricing and access, and I'll hand that over to Sherry.

現在讓我來回答你的第二個問題，也就是關於價格和取得途徑的問題，我把這個問題交給雪莉來回答。

David, thank you for the question. While we have not disclosed our WAC price, we do believe there is significant value in our innovation. As you know, the branded epinephrine market has been set by the currently available product. So with that being said, we understand the challenges, and we plan to price responsibly with a patient-first approach to our pricing. We have and we're continuing to explore a lot of options to ensure that there is broad access, which includes cash pay, co-pay savings program. And we're actively working with the payers for coverage.

大衛，謝謝你的提問。雖然我們尚未公佈 WAC 價格，但我們相信我們的創新具有巨大的價值。如您所知，品牌腎上腺素市場是由目前市面上的產品決定的。因此，我們理解其中的挑戰，並計劃以患者至上的定價方式進行負責任的定價。我們已經並將繼續探索多種方案，以確保廣泛的可及性，包括現金支付、共同支付節省計劃。我們正積極與支付方協商醫保覆蓋事宜。

So we do plan to have a range of options for patients to be able to access Anaphylm. But as you know, the path to a patient having an Anaphylm or any product in hand takes a lot of work. And so access and patient support is critical. We have been spending our time and our resources with payers engaging in preapproval information exchange with our clinical team and the clinical teams of payers. We have what we believe is a very strong value prop and our strategy is beneficial to patients. So we will continue to -- we'll come back to you at the right time with what will set pricing. But I think that you can certainly look around us to get an idea.

因此，我們計劃為患者提供多種選擇，以便他們能夠獲得 Anaphylm。但如您所知，要讓患者拿到 Anaphylm 或任何其他產品，需要付出很多努力。因此，獲得醫療服務和患者支持至關重要。我們一直投入時間和資源與支付方進行預先批准資訊交流，我們的臨床團隊與支付方的臨床團隊進行溝通。我們相信我們擁有非常強大的價值主張，而且我們的策略對病人是有益的。所以我們會繼續——我們會在合適的時機與您聯繫，確定價格。但我認為，你當然可以從我們周圍觀察來獲得一些啟發。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·費茲傑拉。

This is Rick Miller on for Kristen. We'll have one here and then a follow-up on potential partnerships ex US, you're moving forward with these regulatory interactions. So how do you think about the optimal timing from a value perspective as to when to partner out ex US? And maybe give a sense of what those potential partner conversations have been like at this stage? And then we'll have another follow-up.

這裡是瑞克·米勒，替克里斯汀報道。我們這裡會有一個，然後會跟進美國以外的潛在合作夥伴關係，你們正在推動這些監管方面的互動。那麼，從價值角度來看，您認為與美國以外的夥伴合作的最佳時機是什麼？或許還可以介紹一下目前與潛在合作夥伴的對話情況？然後我們也會進行後續跟進。

Sure. So obviously, we see Anaphylm as being a global product. We think it can be broadly distributed across a variety of markets. And so we've started that work now to go into the major markets outside the US. Clearly, EMA, Canada, the UK, Japan, those are the key places from a value perspective, but obviously, even broader across the world, the need is real. In terms of -- and we have also publicly stated, just to remind everyone, that we're not interested in having an international footprint of our own so we will license outside of the US.

當然。顯然，我們認為 Anaphylm 是一款全球性產品。我們認為它可以廣泛分銷到各種市場。因此，我們現在已經開始著手進軍美國以外的主要市場。顯然，從價值角度來看，歐洲市場、加拿大、英國、日本是關鍵地區，但顯然，即使在世界範圍內，這種需求也是真實存在的。關於這一點——我們也曾公開聲明，提醒大家，我們對建立自己的國際業務不感興趣，所以我們將在美國以外地區進行授權。

In terms of when the right time is to partner, those conversations are always ongoing. Clearly, the closer you are to an approval, the more valuable the product and the partnership can be. So from my perspective, we need to get farther along with our regulatory interactions. In Canada, we'll have a filing, we believe, in the first half. In Europe, we'll know shortly if there's any work to do in addition to what we've done to be prepared for our filing and then we'll move on to a filing. So I think as we move towards those steps, that's a good inflection point for the conversations that are already active to get to something that is meaningful and real for the organization.

至於何時才是建立合作關係的最佳時機，這方面的討論一直都在進行中。顯然，離獲得批准越近，產品和合作關係就越有價值。所以從我的角度來看，我們需要在監管互動方面取得更大進展。我們相信，上半年我們會在加拿大提交一份文件。在歐洲，我們很快就會知道除了我們已經在做的準備工作之外，是否還有其他工作要做，然後我們就會著手提交申請。所以我認為，隨著我們朝著這些步驟邁進，這是一個很好的轉捩點，讓已經進行的對話能夠朝著對組織有意義和實際的方向發展。

And maybe then you mentioned being at the conference right now. What are some of the takeaways you're hearing around the conference, especially around your medical affairs booth as it relates to excitement for new potential additional needless epinephrine options?

然後你可能提到了你現在正在參加會議。在本次大會上，尤其是在您的醫療事務展位附近，您聽到了哪些關於人們對新的、潛在的、無需額外注射腎上腺素的選擇感到興奮的消息？

Sure, sure. Well, I have to say that the main part of the conference is ahead of us. So the medical booth and the exhibition hall and all of those things starts tomorrow. So we're all here getting ready and excited about it tonight. We'll actually have a bunch of our investigators together to talk about our program and what they're excited about.

當然，當然。嗯，我得說，會議的真正部分還在後面。所以，醫療攤位、展覽廳以及所有這些活動明天就開始了。所以今晚我們都在這裡做準備，都很興奮。我們將召集一批研究人員，一起探討我們的計畫以及他們感到興奮的地方。

I will tell you that as I walk the halls with people who are getting ready for the conference here, one, the amount of comments that are around the excitement of our product coming is palpable. And two, the desire to know and learn more is real. So to me, those are two really good signs that we've hit a need that is meaningful, and we'll obviously be continuing those conversations throughout the weekend.

我可以告訴你，當我在這裡和準備參加會議的人們一起走在走廊上時，我可以明顯感受到大家對我們產品即將推出的興奮之情。第二，求知慾和學習欲是真實存在的。所以在我看來，這兩個跡像都表明我們已經滿足了真正有意義的需求，我們顯然會在整個週末繼續進行這些討論。

Raghuram Selvaraju, H.C. Wainwright & Co.

拉古拉姆‧塞爾瓦拉朱 (Raghuram Selvaraju)，H.C.溫賴特公司

Firstly, with respect to the Anaphylm outlook, I was wondering if you could, a, perhaps give us a sense of how you are thinking about the parameters you anticipate sharing with the investment community as and when Anaphylm gets to the market and what specific takeaways you are planning to get from the neffy commercial introduction, in particular with respect to factors that might educate how you position Anaphylm in the market upon launch. And also if you could comment on the MSN pricing situation and how this affects your approach to thinking about pricing in ex US markets.

首先，關於Anaphylm的前景，我想請您談談，您打算在Anaphylm上市時與投資界分享哪些參數，以及您計劃從neffy的商業推廣中獲得哪些具體經驗，特別是關於哪些因素可能會影響您在Anaphylm上市後在市場上的定位。另外，能否請您談談 MSN 的定價情況，以及這會如何影響您對美國以外市場定價的思考方式？

Yes. Ram, so I'll take a few of those pieces. And in terms of the positioning in particular, I'll hand it over to Sherry in a minute. So in terms of when we plan to come to market. So our PDUFA date is January 31. Our guidance remains the same that we believe we'll be able to launch in the first quarter, so by launch, we mean have sales reps trained and in place and have our supply chain providing product to distributors for fulfillment of prescriptions.

是的。拉姆，所以我會拿走其中的一些。至於具體的定位問題，我稍後會交給雪莉來解答。所以，就我們計劃何時進入市場而言。所以我們 PDUFA 日期是 1 月 31 日。我們仍然堅持先前的預期，相信我們能夠在第一季推出產品。所謂推出，是指銷售代表培訓到位，供應鏈向分銷商提供產品，以滿足處方需求。

In terms of -- let me actually go to the last piece first, the most favored nation pricing, we are following that closely. Right now, we don't see any impact on our ex US potential partnerships and how that would affect pricing here in the US. But obviously, we'll be keeping an eye on that. And as legislation or executive orders evolve, we'll make sure that our -- we're at the right stage where we can make sure we protect the US market from any of those issues that pop up.

至於——其實我先來說說最後一點，最惠國定價，我們正在密切關注。目前，我們沒有看到任何對我們在美國以外的潛在合作夥伴關係的影響，也沒有看到這將如何影響美國市場的定價。但很顯然，我們會密切關注此事。隨著立法或行政命令的演變，我們將確保我們處於合適的階段，從而能夠保護美國市場免受任何可能出現的問題的影響。

So in terms of positioning, before I hand it over to Sherry, just a couple of global comments from me. One, we are clearly different from the medical devices that are in the market. And I'm sure Sherry will say way better than I will why we believe that so firmly. Two, when I look at the market and what happened in Q3, and it follows Q2 and Q1, this market is growing. And it's actually growing in the auto-injector space. 95% of the scripts are auto-injectors. So that is the focus. That is the spot where the market is for us to go grab, and that's where our energy will be. But I'll let Sherry talk about how we're positioned.

所以，在把麥克風交給雪莉之前，關於定位方面，我先簡單提幾點整體看法。第一，我們與市面上的醫療器材顯然不同。我相信雪莉會比我更好地解釋我們為什麼如此堅定地相信這一點。第二，當我觀察市場以及第三季的情況，並考慮到第二季和第一季的情況，這個市場正在成長。而且它在自動注入器領域實際上正在成長。 95%的腳本都是自動注入器。這就是重點。那裡就是我們可以去搶佔的市場，那裡也是我們投入精力的地方。但我會讓雪莉來談談我們的市場定位。

Yes. Thanks so much, Ram, and thanks for the question. As we think about our launch, we are taking a differentiated, focused, patient-centric approach along with a very disciplined commercial strategy. And then that puts us on track for a highly successful launch. What we know is that patients want choice. They have not had choice for decades. And so when we speak to -- when we're doing our market research, and Dan alluded to it earlier in the call, we find that the allergy community, whether it is patients, caregivers, advocacy organizations and the HCPs, they all continue to be very positive.

是的。非常感謝Ram，也感謝你的提問。在考慮產品上市時，我們採取了差異化、專注、以患者為中心的策略，並輔以非常嚴謹的商業策略。這樣一來，我們就能走上成功發布的道路。我們知道，患者希望有選擇權。幾十年來，他們別無選擇。因此，當我們進行市場研究時——正如丹在先前的通話中提到的那樣——我們發現，過敏症群體，無論是患者、護理人員、倡導組織還是醫療保健專業人員，他們都繼續保持非常積極的態度。

And why is that? Well, patients went choice, as I said. And mothers, who are the Chief Medical Officers of the home, as you know, are telling us that because Anaphylm is the easiest to carry, it's the easiest to use and it's fast acting, that Anaphylm is a great choice. And so for the millions of people that are at risk for anaphylaxis who may have avoided epinephrine, did the device and bulk and needle anxiety, the fact that Anaphylm is not a device, that form factor is so critically important, and it really removes the final barrier to people caring and having epinephrine on hand at all times.

為什麼會這樣呢？正如我所說，患者們有自己的選擇。如你所知，母親們是家中的首席醫務官，她們告訴我們，由於 Anaphylm 最容易攜帶、最容易使用且起效迅速，因此 Anaphylm 是一個很好的選擇。因此，對於數百萬可能因為腎上腺素的體積、劑量和針頭焦慮而避免使用腎上腺素的過敏性休克患者來說，Anaphylm 不是一種設備，這種外形尺寸至關重要，它真正消除了人們隨時攜帶腎上腺素進行護理的最後一個障礙。

The guidelines recommend always have two forms of epinephrine. So always carry two auto-injectors or carry two nasal devices. And so what Anaphylm does is it removes that barrier because, as you know and you've seen, it fits right in the back of your phone or in a small wallet. I think the other thing really to keep in mind that is critically important, and we continue to hear this in our market research and engagement with physicians is Anaphylm's exceptional stability profile means that Anaphylm can perform across diverse real-world conditions.

指引建議始終備有兩種形式的腎上腺素。所以，務必隨身攜帶兩個自動注射器或兩個鼻腔注射器。因此，Anaphylm 的作用就是消除這種障礙，因為如你所知，它也確實可以放在手機背面或小錢包裡。我認為另一件非常重要的事情需要牢記，我們在市場研究和與醫生的交流中也不斷聽到這一點，那就是 Anaphylm 卓越的穩定性意味著 Anaphylm 可以在各種真實世界的條件下發揮作用。

So I think there's a lot of differentiation between, we believe, and patients, caregivers and HCPs are out telling us between Anaphylm versus the devices. And we continue to -- we'll be driving that message as we launch in Q1.

所以我認為，我們相信，患者、照護者和醫療保健專業人員都在告訴我們，Anaphylm 與這些設備之間存在著許多差異。我們將繼續——我們將在第一季發布產品時繼續傳遞這一訊息。

Very helpful. And just very quickly on the Adrenaverse platform. I was wondering if you could comment on what the alternative routes of administration and formulations are starting to look like beyond AQST-108, if there are other topical gels or if you're looking at deploying the Adrenaverse platform via alternative routes of administration beyond the topical arena? And then lastly, just very quickly for Ernie. I was wondering, if you look at the debt refinancing initiatives, what you are prioritizing most, is it the longest possible maturity date? Or is it the lowest possible coupon? Just give us a sense of what you're looking to accomplish there.

很有幫助。在 Adrenaverse 平台上快速瀏覽一下。我想請您談談除了 AQST-108 之外，其他給藥途徑和製劑的發展趨勢，例如是否有其他外用凝膠，或者您是否正在考慮透過外用以外的其他給藥途徑來推廣 Adrenaverse 平台？最後，簡單說一句，給厄尼。我想知道，如果您審視債務再融資計劃，您最優先考慮的是什麼？是盡可能長的到期日嗎？還是這是最低的優惠券？請您簡要說明您希望在那裡實現什麼目標。

Why don't I have Ernie take the second part and then I'll address AdrenaVerse.

不如我先讓厄尼來做第二部分，然後再談談腎上腺素宇宙。

Ram, so what we're looking for most of all, besides the things that you talked about, we're always looking for a coupon and the lowest interest rate and the flexibility, is really finding a partner that we can grow with as the company grows and someone that we feel we can work with as we move forward to grow the company.

Ram，所以除了你提到的那些之外，我們最看重的是優惠券、最低利率和靈活性，我們真正想要的是一個能夠隨著公司發展而共同成長的合作夥伴，一個我們感覺可以一起努力發展公司的合作夥伴。

And we've been very fortunate as we've gone through this process. The number of lenders, potential lenders that we've spoken to that have wanted to partner with us and to meet those qualifications. So we feel we're in a good place. And as I said in my script, we hope to be able to announce that new debt partner in the very near future.

在這個過程中，我們一直都非常幸運。我們已經接觸過許多貸款機構和潛在貸款機構，他們都希望與我們合作並符合這些條件。所以我們感覺現在處境不錯。正如我在稿子裡所說，我們希望能夠在不久的將來宣布新的債務夥伴。

And to take the other question, Ram, which thank you. I appreciate you pointing that out. So the sky is the limit right now in terms of the types of delivery systems we use with our Adrenaverse platform. Now that we have -- and we've created the Chief Development Officer role, and we have someone focused on our pipeline who has the depth of experience that Matthew Davis has, we'll, of course, continue the cream gel foam work that we're doing. But there are indications that could be envisioned in a variety of different routes of administration including film, capsules, potentially even if it was something that required it, injectables are available. So we're not limiting ourselves to the route of delivery. We're much more focused on as we have been with Anaphylm, what is right for the patient for the solution we're trying to bring.

至於另一個問題，Ram，謝謝你。感謝你指出這一點。所以，就我們Adrenaverse平台所使用的交付系統類型而言，目前還沒有極限。現在我們已經設立了首席開發官一職，並且有像 Matthew Davis 這樣經驗豐富的人專注於我們的產品線，我們當然會繼續我們正在進行的乳霜凝膠泡沫工作。但有跡象表明，可以透過多種不同的給藥途徑進行給藥，包括薄膜、膠囊，甚至如果需要的話，也可以注射。因此，我們並不局限於配送路線。就像我們之前在 Anaphylm 一樣，我們更重視的是如何為患者提供最合適的解決方案。

Andreas Argyrides, Oppenheimer & Co.

Andreas Argyrides，奧本海默公司

We'll go with a couple from us, not just the one that you guys suggested. So how are the current launch dynamics with neffy informing your initial commercialization strategy? Particularly, what are some of the tools you can use to create awareness? Are you considering DTC? And then in your dialogue with the FDA, can you remind us what components of the data they are focused on and key considerations for approval? And then lastly, given the product profile, how should we think of scripts per patient per year? Is it multipack? I'll stop there.

我們會從自己的想法中選幾個，不只是你們建議的那個。那麼，目前Neffy的上市動態如何影響你們的初始商業化策略？具體來說，您可以使用哪些工具來提高公眾意識？您是否考慮過直接面向消費者（DTC）模式？那麼，在您與FDA的對話中，您能否提醒我們，他們關注的是數據的哪些方面，以及批准的關鍵考慮因素？最後，考慮到產品特性，我們應該如何考慮每位患者每年的處方量？是多件裝嗎？我就說到這裡吧。

Sure, Andreas. And I'll have to find out the question that we recommended to you. I'm kind of curious to know what that was. But having said that --

當然，安德烈亞斯。我得查一下我們推薦給你的這個問題。我很好奇那是什麼。但話雖如此--

It was limiting -- Dan, it was limiting you to one question per analyst.

這有限制——丹，這限制了你每個分析師只能問一個問題。

Got you. I thought we were giving you questions. How about that. That was news to me. I think that was more trying to manage the time. But Andreas, of course, happy to answer your questions and spend time with you. So let me take a couple of those. In terms of awareness, I will hand that over to Sherry in a minute here.

抓到你了。我以為我們是在給你提問。真是這樣嗎？我對此毫不知情。我覺得那更多的是為了更好地管理時間。當然，安德烈亞斯很樂意回答你的問題，並花時間陪伴你。讓我拿幾個來。關於意識方面，我稍後會把這個話題交給雪莉。

In terms of where the FDA has been focused, it has -- and just to remind everyone, we have six FDA approvals in our past. So when you go through the FDA approval process, there's a cadence, there's a pace, there's a feel. And you look for the questions to come from a variety of areas. And that's what we're seeing here that the different functions in the FDA are doing their jobs, completing their checklists and asking us the questions you would expect. So that feels really good.

就 FDA 的關注點而言，它確實——提醒大家一下，我們過去曾獲得 6 次 FDA 批准。所以，當你經歷 FDA 審批流程時，會有一個節奏、一個速度、一種感覺。而且，你希望問題來自各個領域。我們看到，FDA 的各個部門都在履行職責，完成檢查清單，並向我們提出我們預期會遇到的問題。感覺真好。

In terms of DTC, when I hear DTC, I will admit I default to big television ads like the World Series or the Super Bowl and splashy campaigns. Sherry and I are very aligned. We're not doing that in 2026. Now in 2027, 2028, who knows? But before I hand it over to Sherry, that stuff, you won't see. And that's where we'll be very efficient. But let me have Sherry tell you more about her thoughts on awareness.

就 DTC 而言，當我聽到 DTC 時，我承認我首先想到的是像世界大賽或超級盃這樣的大型電視廣告和引人注目的行銷活動。我和雪莉的理念非常一致。我們2026年不會這樣做。現在到了2027年、2028年，誰知道呢？但在我把它交給雪莉之前，那些東西，你不會看到的。而這正是我們能夠高效運作的地方。但還是讓雪莉來跟你們詳細說說她對意識覺醒的看法吧。

And thanks for the question. One of the benefits of being second is that you get to see what those ahead of you went through. And so our teams continue to systematically assess and gather insights from the most recent launch to inform our commercialization plans. But I'm going to go back to -- and I'm going to keep coming back to our plan is very differentiated in that we are going to be very focused, very disciplined and have a patient-centric launch.

謝謝你的提問。第二名的好處之一是，你可以看到排在你前面的人經歷了什麼。因此，我們的團隊將繼續有系統地評估和收集最近一次產品上市的經驗，以指導我們的商業化計劃。但我要回到——而且我會一直強調——我們的計劃非常獨特，因為我們將非常專注、非常自律，並以患者為中心推出產品。

And so while our competitors may have gone out with be very broad in all of their sales and marketing tactics, we're applying this very disciplined approach to focus on and drive adoption among the most productive prescribers at launch. And as I said a lot of times, the epinephrine market is an inch deep and about 10,000 miles wide. Prescribers range from primary care physicians who write one to two prescriptions annually to allergists who prescribe 200-plus prescriptions of epinephrine per year.

因此，儘管我們的競爭對手可能在所有銷售和行銷策略上都採取了非常廣泛的策略，但我們卻運用了這種非常嚴謹的方法，專注於在產品上市初期就吸引並推動最有效率的處方醫生採用。正如我多次說過的那樣，腎上腺素市場雖然只有一英寸深，但寬度卻有大約 10,000 英里。開處方的醫生範圍很廣，從每年開一到兩張處方的初級保健醫生到每年開出 200 多張腎上腺素處方的過敏症專家都有。

And so the allergists are the most productive segment, and so we are taking a very disciplined approach with the allergists to launch. And so what you'll find is we will -- as we drive our results, as we -- our market access and payer coverage comes on board, we will have the ability to scale. And so that is a different approach that we're employing.

因此，過敏科醫生是最有生產力的群體，所以我們對過敏科醫生採取了非常嚴謹的推廣方式。因此，你會發現，隨著我們取得成果，隨著我們的市場准入和支付方覆蓋範圍的擴大，我們將有能力擴大規模。所以，這是我們採用的一種不同的方法。

As it relates to DTC, Dan and I always -- we do laugh about this, what is DTC? At the end of the day, we're applying that same disciplined approach to DTC. Our prelaunch plans and activities have been focused on HCP. Dan mentioned the CME activities. We've also been driving non-CME programs, publications, congresses, being with the community KOLs and state level allergy associations and congresses.

關於 DTC，我和 Dan 總是——我們經常拿這個問題開玩笑，DTC 是什麼？歸根究底，我們將同樣的嚴謹方法應用於 DTC 模式。我們的上市前計劃和活動一直以醫療保健專業人員 (HCP) 為重點。丹提到了繼續醫學教育活動。我們也積極推動非繼續醫學教育計畫、出版品、大會，與社區意見領袖和州級過敏協會及大會保持聯繫。

Our plan post launch is to drive awareness, number one, and most importantly, with those allergists and to get them ready to prescribe as they see the patients that come in who are patients who will benefit from Anaphylm. That's very important. Over time, we will layer in then that strong consumer and caregiver awareness. But there is a disciplined, timed approach to it. So you will see DTC from us, not necessarily TV in year one, but there will be a number of activities, digital, print, et cetera, that are aimed at the consumer.

我們上市後的計劃是提高人們的意識，這是首要任務，也是最重要的任務，是讓過敏科醫生做好準備，以便在遇到能夠從 Anaphylm 中受益的患者時，能夠及時開具處方。這非常重要。隨著時間的推移，我們將逐步增強消費者和照護人員的意識。但這樣做需要有條不紊、分步驟。所以你會看到我們推出的 DTC 服務，第一年不一定是電視廣告，但我們會進行一系列面向消費者的活動，包括數位媒體、印刷品等等。

And Andreas, I'll take a question one part D. So in terms of the number of scripts, rather than -- so the way we look at it, there is a desire among this patient population to have multiple scripts because they want to have product put in different places, at grandma's house, in their child bag, at the nurse's office, in their bag or on the back of their phone. And so there's a reality around pricing and market access that all of us, not just Aquestive, but all of us have to work through. But our goal is to enable people to have as many scripts as possible.

安德烈亞斯，我來回答D部分的問題。就處方數量而言，我們認為，這部分病患群體希望擁有多張處方，因為他們希望將藥品放在不同的地方，例如奶奶家、孩子的書包裡、護士辦公室、自己的包包或手機背面。因此，定價和市場准入方面存在著一個現實問題，這個問題不僅是 Aquestive 的問題，而是我們所有人的問題，我們都必須面對。但我們的目標是讓人們能夠擁有盡可能多的劇本。

Francois Brisebois, LifeSci Capital.

布里斯博瓦 (Francois Brisebois)，生命科學資本。

So just a couple. Can you -- Sherry, you kind of talked about a more targeted approach. Can you break down a little bit more on the allergist front? And just how many are there? And are they tiered in terms of like certain allergists are definitely the ones to target at first? And then can you touch on how many reps could help you get to that point?

就一對。你能——雪莉，你剛才好像提到要採取更有針對性的方法。能再詳細說說過敏專科醫生方面的情況嗎？到底有多少？他們是否按等級劃分，例如某些過敏專科醫生是首先應該重點關注的對象？那麼，您能否談談做多少次重複練習才能達到那個效果？

Yes. It's a good question. Thanks so much for answering that. As I mentioned, the allergists are the most productive segment. They prescribe on average 200 prescriptions annually. That's a lot of prescriptions. So our reps will be focused in the allergy space to call on all of the allergists. Now obviously, within that allergist pool, there are some prescribers that are more productive than others.

是的。這是個好問題。非常感謝您的解答。正如我之前提到的，過敏科醫生是最有效率的群體。他們平均每年開出 200 張處方。處方數量可真是不少。因此，我們的代表將專注於過敏領域，並拜訪所有過敏專家。顯然，在過敏科醫生群體中，有些醫生的處方量比其他醫生大。

But overall, we know that by -- and based on my experience, as you probably know, I ran the EpiPen brand team for a number of years where we grew the market from about 1.5 million scripts to 3 million scripts. And so what we know is and what I know is that allergists space is key. When you think about the prescriber base, that prescriber base of about 5,000, we would expect to launch with the sales force, as we've said publicly before, between that 50 to 60 reps and managers.

但總的來說，我們知道——而且根據我的經驗，正如你可能知道的那樣，我曾領導 EpiPen 品牌團隊多年，我們將市場從大約 150 萬張處方增長到 300 萬張處方。因此，我們知道，而且我也知道，過敏專科醫生的空間至關重要。考慮到處方醫生群體，大約有 5000 名處方醫生，我們預計銷售團隊將與銷售人員一起啟動，正如我們之前公開說過的那樣，銷售人員包括 50 到 60 名銷售代表和經理。

Okay. Great. And then maybe, Dan, you touched on the growth of the market. I think that's coming up a lot. A lot of people are interested in whether or not this market, just you're taking share of it or you're growing the whole thing. Can you help us understand where the 9% you mentioned come from?

好的。偉大的。然後，丹，你可能也談到了市場的成長。我覺得這個問題常被提及。很多人都想知道，在這個市場中，你是僅僅佔據了一部分份額，還是正在發展整個市場。您能幫我們了解一下您提到的9%是從哪裡來的嗎？

Yes. Yes, Frank. So to give a little bit more precise when we just look at the script data that's in the systems we can access, 8.8% growth in Q3, 7.5% growth year-to-date in the space. When you break that down into where the growth is coming from, by far, the larger number of script growth is in auto-injectors. So I think what you're seeing is as awareness is pulled into the space, that just grows -- it's the rising tide raises all boats is our interpretation of what we're seeing.

是的。是的，弗蘭克。為了更精確地說明情況，當我們查看我們可以存取的系統中的腳本資料時，第三季成長了 8.8%，今年迄今成長了 7.5%。如果將成長來源細分，就會發現腳本成長的大部分來自自動注入器。所以我覺得你看到的是，隨著人們的意識被帶入這個領域，它就會不斷發展壯大——這就是我們對所見現象的解釋，就像水漲船高一樣。

The second biggest category, of course, is the nasal spray scripts. So we do think that you're seeing the two elements play out. One is the switch over from one product to another, and two is just the expansion of the overall market. So we think that's a very healthy place to be. 95% of scripts remain auto-injectors, and that's what we'll target.

當然，第二大類是鼻噴劑處方。所以我們認為你確實看到了這兩個因素的相互作用。一是產品間的轉換，二是整體市場的擴張。所以我們認為這是一個非常健康的現狀。 95%的腳本仍然是自動注入器，而這正是我們將要重點關注的對象。

Jason Butler, Citizens.

傑森巴特勒，市民。

First one, when you speak to physicians, when you do your market research, aside from the advantages of the administration route and convenience of administration, what are the aspects the physicians -- product profile the physicians are really focusing on? To what extent is it PK profile versus safety tolerability versus anything else? And then just another question on your comments about the Adrenaverse platform. Does part of this effort involves applying the prodrug technology to any other molecules beyond epinephrine?

首先，當你與醫生交談，當你進行市場調查時，除了給藥途徑的優勢和給藥的便利性之外，醫生們真正關注的產品概況方面是什麼？PK特性、安全性和耐受性以及其他因素在多大程度上決定了決策？最後，關於您對 Adrenaverse 平台的評論，我還有一個問題。這項研究是否包括將前藥技術應用於腎上腺素以外的其他分子？

Yes. Jason, so I'll give my initial thought, but I'll ask Dr. Gary Slatko, to give his view on what will be most important from physicians from an efficacy or safety profile perspective. So what I've seen is that you have a product with EpiPen that's been in the market for 45 years, right? So the HCPs want to make sure that the product we're bringing to market has the same ability to help patients that the product that's been out there for 45 years has done. And I think we have a really compelling package that does that.

是的。傑森，我會先說說我的初步想法，但我會請加里·斯拉特科醫生談談，從療效或安全性角度來看，醫生最關心的是什麼。我看到的是，你們的 EpiPen 產品已經上市 45 年了，對嗎？因此，醫療保健專業人員希望確保我們推向市場的產品能夠像已經上市 45 年的產品一樣，幫助患者。我認為我們有一個非常有吸引力的解決方案，可以做到這一點。

And I'll let Gary add his thoughts.

接下來，我將讓加里補充他的想法。

Yes. I think many of the products in the epinephrine class are intended to stabilize the cardiovascular system in the event of anaphylaxis and reverse the mast cell degranulation that's occurring that's underlying the allergic reaction. And the characteristics we've seen in terms of blood levels and pharmacodynamic effects are very similar across the board to the comparator products. Anaphylm has a couple of interesting characteristics that might translate into clinical benefit, but would need further studies such as its speed of increase in its blood level and early time to maximum concentration and its sustained effect as well are both could bode well for having a treatment benefit in patients who need an early robust intervention.

是的。我認為腎上腺素類產品中的許多產品旨在穩定過敏性休克時的心血管系統，並逆轉引起過敏反應的肥大細胞脫顆粒。就血液濃度和藥效學效應而言，我們所觀察到的特徵與對照產品非常相似。Anaphylm 具有一些有趣的特性，可能會轉化為臨床益處，但還需要進一步研究，例如其血液濃度上升速度、達到最大濃度的早期時間以及持續效果，這些都可能預示著對需要早期強效幹預的患者俱有治療益處。

I think the other thing that -- the question that clinicians might have it has to do with can it be administered -- can it be administered and is it safe? And administration, we have a very robust human factors program, which has looked at everything which way about different conditions of administration, self-administration and the like. And all of them have shown that this product can be administered in the field by patients successfully. And the safety profile, as with all epinephrines, is consistent with what we see with all the existing product. So I think we've got a very comparable profile overall and some interesting potential advantages.

我認為臨床醫生可能會問的另一個問題是——它是否可以進行——它是否安全？在行政管理方面，我們有一個非常健全的人為因素計劃，該計劃從各個方面研究了不同的行政管理條件、自我管理等等。所有這些研究都表明，患者可以在現場成功使用該產品。與所有腎上腺素類藥物一樣，其安全性也與所有現有產品一致。所以我認為我們整體情況非常相似，並且有一些有趣的潛在優勢。

Yes. And let me move on to the second question, Jason, you had, which was around Adrenaverse. So look, just prodrugs is not that unique in our space. So I don't know -- our intellectual property estate really is around epinephrine in a prodrug form because that's the white space we found and created. So I think in the near term, you'll see us focus on solely epinephrine.

是的。接下來，我想回答你的第二個問題，Jason，這個問題是關於 Adrenaverse 的。所以你看，前驅藥物在我們這個領域並不是那麼獨特。所以我也不知道——我們的智慧財產權確實圍繞著腎上腺素前藥形式展開，因為這是我們發現並創造的空白領域。所以我認為在短期內，我們將只專注於腎上腺素。

But with the significant resources and expertise we're bringing into our development area, we, of course, are always looking at what other technologies or expansion in technologies can we meaningfully use to bring better products to the patients.

但是，憑藉我們投入研發領域的豐富資源和專業知識，我們當然一直在尋找其他技術或技術擴展，以便有效地利用這些技術為患者帶來更好的產品。

(Operator Instructions)

（操作說明）

Gary Nachman, Raymond James.

Gary Nachman，Raymond James。

This is Denis Reznik on for Gary Nachman. So you recently announced two new patents for Anaphylm. Can you just talk more about them and how important these two specifically are for the overall patent portfolio? And then on supply chain, assuming an on-time approval, how quickly could you get drug into channel? And then how quickly can you get the first prescription filled?

這裡是丹尼斯·雷茲尼克，代替加里·納赫曼為您報道。所以您最近宣布了 Anaphylm 的兩項新專利。您能否詳細介紹一下這兩項專利，以及它們對整體專利組合的重要性？那麼在供應鏈方面，假設審批及時，藥物最快能以多快的速度進入通路？那麼，你多久能拿到第一張處方藥呢？

And then if I could just squeeze in one more. Regarding the uncertainty at the FDA that we've been hearing about recently, can you just mention if there's been any high-level individuals that are involved in your review that have been either replaced or have moved on?

如果我能再擠出一個就好了。關於我們最近聽到的有關 FDA 的不確定性，您能否提及一下，在您的審查過程中，是否有任何高層人員被替換或離職？

Sure. Thanks, Dennis. So in terms of the patents, yes, we had two new patents issued just over a month ago. And both of those patents are focused on the ability to gain absorption and then rapid release of epinephrine cleavage of -- enzymatic cleavage of epinephrine back into its native form. So we believe those are significant Orange Book listable patents. When we're approved, that will be very expansive and blocking for the product. So definitely fundamental to our position.

當然。謝謝你，丹尼斯。所以就專利而言，是的，我們在一個多月前獲得了兩項新專利。這兩項專利都著重於吸收和快速釋放腎上腺素的能力，即透過酶促裂解將腎上腺素還原成其天然形式。因此，我們認為這些都是重要的、可以列入橙皮書的專利。一旦獲得批准，這將對產品造成非常大的影響和阻礙。所以這對我們的立場來說絕對至關重要。

From a supply chain perspective, look, there's a little bit of work that has to happen, right, when you get approval. So you have to work on the final label, get all the pieces and parts together. We have a great supply chain component of our business. It does go to the core of where we've come from as an organization. I think you know we manufacture in-house. So that will be something we're very ready for and will allow us to have supply in the channel in Q1.

從供應鏈的角度來看，你看，獲得批准後，還有一些工作要做，對吧。所以你需要完善最終的標籤，把所有的零件都整合起來。我們業務中擁有強大的供應鏈環節。這確實觸及了我們作為一個組織從何而來的核心問題。我想您應該知道我們是自主生產的。所以我們已經做好了充分的準備，這將使我們能夠在第一季向通路供貨。

And then the third question, the uncertainty at the FDA, I'm actually -- thank you, Dennis, for bringing it up. I'm actually, I guess, pleasantly surprised that we got this far into the Q&A before that question came up. Clearly, the FDA is going through some pains. From our perspective, our review group has remained the same. We did -- as you heard in my prepared comments at the beginning, we've heard from our project manager that our application is not affected.

然後是第三個問題，關於 FDA 的不確定性，我其實——謝謝 Dennis 提出這個問題。其實，我挺驚喜的，問答環節居然進行到這一步才出現這個問題。顯然，FDA現在遇到了一些麻煩。從我們的角度來看，我們的評審小組保持不變。正如您在我開頭準備好的演講中聽到的那樣，我們的專案經理告訴我們，我們的應用程式沒有受到影響。

Obviously, we saw the Head of CDER left over the weekend. But from our perspective, the leadership at CDER is more of just a sign-off on our application than an active reviewer. So we continue to believe we're in good shape on that front.

顯然，我們看到CDER的負責人已於週末離職。但從我們的角度來看，CDER 的領導層更像是對我們的申請進行簽字認可，而不是積極參與審查。所以我們仍然相信我們在這方面處於良好狀態。

(Operator Instructions)

（操作說明）

James Molloy, Alliance Global Partners.

James Molloy，Alliance Global Partners。

Let me follow up a little more on the manufacturing capacity. What do you guys -- at the capacity on approval, can you guys supply the whole market on approval? And where do you guys -- where is Anaphylm manufactured? And then I don't know if you guys have given any -- on the Anaphylm, what's the pushback that you've gotten from docs on Anaphylm? Because seems like the feedback is very positive to date.

關於生產能力，我再補充一點。你們的產能一旦獲得批准，能否滿足整個市場的供應需求？你們知道Anaphylm是在哪裡生產的嗎？然後，我不知道你們有沒有給 Anaphylm 開過藥，你們從醫生那裡得到了什麼反對意見？因為到目前為止，回饋似乎都非常正面。

Sure. So I think I heard your first question, right, Jim. Good to hear you voice. Manufactured capacity and where is it manufactured? Capacity-wise, so we, this year, will make 150 million doses of film for all of our other partnerships and arrangements. So when you look at the entire epinephrine market being less than 10 million doses, that means we have plenty of space to make this product. In terms of where it's manufactured, our manufacturing is in Indiana. We do have some component manufacturers that go into our products that are all US-based. So we are a completely US-based manufacturer.

當然。我想我聽到了你的第一個問題，對吧，吉姆。很高興聽到你的聲音。生產能力以及生產地點？從產能來看，今年我們將為所有其他合作夥伴和安排生產 1.5 億劑膠片。所以，考慮到整個腎上腺素市場需求量不到 1000 萬劑，這意味著我們有足夠的空間來生產這種產品。至於生產地點，我們的生產基地位於印第安納州。我們產品中使用的部分零件製造商都位於美國。所以，我們是一家完全位於美國的製造商。

And from Anaphylm, I think your question was what are we hearing from physicians that may be a little bit of pushback or need to be convinced. And I would go back to what Gary said before. With any new product, the first thing you need physicians to feel comfortable with is the safety and efficacy of the product. So that's foundational. We understand that. You heard the depth that Gary brought to how he thinks about it. That's what our medical affairs team is doing every day. And we're prepared to make sure we do a really good job with that piece.

至於 Anaphylm，我認為你的問題是，我們從醫生那裡聽到了什麼，他們可能有些抗拒情緒或需要被說服。我還是想重申一下加里之前說過的話。對於任何新產品而言，首先需要讓醫生確信的是產品的安全性和有效性。這是基礎性的。我們明白這一點。你聽出了加里對這個問題思考的深刻見解。這就是我們醫療事務團隊每天都在做的事情。我們已經做好準備，確保把這部分工作做好。

Great. And then maybe just a quick follow-up on 108. Can you talk a little bit on Phase II time you said first half '26 and then sort of the size and the duration of that trial should it get started?

偉大的。然後或許可以簡單跟進第 108 點。您能稍微談談您提到的二期臨床試驗時間（您說是 2026 年上半年），以及如果試驗開始的話，試驗的規模和持續時間嗎？

Yes, yes. And thank you. I love when I get questions on AQST-108, which is our alopecia areata program. And I look forward in future calls having Matthew Davis here to talk in depth about it. But I felt on day four, it was probably unfair for me to have him here. So we -- the first study we'll do is a small safety study, which is in just a handful of men who are bald just to make sure we have the safety data we need to fulfill the FDA's requirements. We will then quickly go into our Phase IIa.

是的，是的。謝謝。我很喜歡收到關於 AQST-108 的問題，這是我們的斑禿治療項目。我期待在未來的電話會議中，馬修戴維斯能來深入探討這個問題。但到了第四天，我覺得讓他留在這裡可能對我不太公平。因此，我們首先要進行一項小型安全性研究，只選取少數禿頭男性作為研究對象，以確保我們擁有滿足 FDA 要求所需的安全性資料。接下來我們將迅速進入第二階段a。

Right now, our design is to have it be a 24-week study. We will have data along the way. And that study will look at hair follicle growth over different periods of time. In terms of the size, we're still scoping that out. But I would think of it as somewhere between 40 and 60 individuals.

目前，我們的計劃是進行為期 24 週的研究。我們將逐步收集數據。研究將觀察不同時間內毛囊的生長情況。至於規模方面，我們還在評估中。但我認為人數應該在 40 到 60 人之間。

Thank you. And I would now like to hand the conference back over to Dan Barber for closing remarks.

謝謝。現在我謹將會議交還給丹·巴伯，請他作閉幕致詞。

Thanks, Michelle. And thank you again to everyone for joining us this morning. We really enjoyed the robust interaction from all the Q&A. And as I said earlier in the call, this is a really exciting time where we really feel everything coming together for the company. We have the right financing, the right people and the positive FDA interactions as of today to remain excited about not just our near-term prospects but our long-term prospects. We look forward to interacting with you again in the near future. And with that, we hope you have a wonderful day.

謝謝你，米歇爾。再次感謝各位今天上午的參與。我們非常享受問答環節中熱烈的互動。正如我之前在電話會議中所說，這是一個非常令人興奮的時刻，我們真切地感受到公司的一切正在朝著好的方向發展。截至目前，我們擁有合適的資金、合適的人才以及與FDA的積極互動，因此我們不僅對近期前景充滿信心，而且對長期前景也充滿信心。我們期待在不久的將來再次與您互動。最後，祝您有美好的一天。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。