Aquestive Therapeutics, Inc. (AQST) 2025 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to Aquestive Therapeutics fourth quarter 2025 conference call (Operator Instructions). Please note that today's conference is being recorded.

大家好，感謝您撥冗等候。歡迎參加 Aquestive Therapeutics 2025 年第四季財報電話會議(接線員指示)。請注意，今天的會議將被錄音。

I will now hand the conference over to your speaker host for today, Faith Pomeroy-Ward.

現在我將把會議交給今天的主持人 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 fourth quarter and full year ended December 31, 2025, and a progress update on the company's key 2026 objectives, followed by a Q&A session.

謝謝，接線員。各位早安，歡迎參加今天的電話會議。今天與我一同出席的有總裁兼執行長 Dan Barber，以及財務長 Ernie Toth；他們將概述公司截至 2025 年 12 月 31 日止第四季與全年已公布的財務結果，並更新公司 2026 年關鍵目標的進展，之後將進行問答環節。

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.

在問答環節中，團隊也將由首席醫療長 Matt Greenhawt 醫師、法規事務資深副總裁 Melina Cioffi、首席商務長 Sherry Korczynski，以及首席開發長 Matthew Davis 醫師一同參與。

As a reminder, the company's remarks today correspond with the earnings release that was issued after market close 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.

提醒各位，公司今天的發言對應於昨日收盤後發布的財報新聞稿。此外，今天會議的錄音及相關補充資料，將在本次電話會議結束後不久，於 Aquestive 官網「投資人」專區提供。

To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of fourth quarter and year-end 2025 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.

再次提醒，今天上午在回顧 2025 年第四季與年終結果時，Aquestive 團隊將討論部分非 GAAP 財務衡量指標。這些指標的說明以及與 GAAP 的調節表，可見於昨日發布並張貼在 Aquestive 官網「投資人」專區的財報新聞稿。

During the call, the company will be making forward-looking statements. We remind you of the company's Safe Harbor language as outlined in today'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 US Securities and Exchange Commission on March 4, 2026.

在本次電話會議中，公司將作出前瞻性陳述。我們提醒各位注意公司在今日財報新聞稿中所載的「安全港」聲明，以及公司於 2026 年 3 月 4 日向美國證券交易委員會提交的 Form 10-K 年報中「風險因素」章節及其他章節所述、影響公司的風險與不確定性。

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 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.

如同任何擁有研發中候選產品及正在商業化產品的製藥公司，公司在業務、產品研發、法規核准與商業化，以及其他營運相關事項方面，均存在重大風險與不確定性。鑑於這些不確定性，您不應過度依賴這些前瞻性陳述；其僅反映作出陳述當日的情況。實際結果可能與這些陳述存在重大差異。

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.

所有可歸因於 Aquestive 或任何代表其行事之人的前瞻性陳述，均在其整體上明確受本項警示聲明以及昨日發布之財報新聞稿中所載警示聲明的限制與約束。除非適用法律另有要求，公司不承擔在本次電話會議日期之後因新資訊、未來事件或其他原因而更新其前瞻性陳述的任何義務。

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

現在我想把電話交給 Dan。

Thanks, Faith. Good morning, everyone, and thank you for joining us. Today, my message to you is simple and clear. This is a great moment in Aquestive's evolution, and I'm filled with optimism for our future. I am filled with optimism because I believe our path has never been clearer.

謝謝，Faith。各位早安，感謝各位加入我們。今天我想傳達的訊息簡單而清楚。這是 Aquestive 演進歷程中的一個重要時刻，我對我們的未來充滿樂觀。我之所以充滿樂觀，是因為我相信我們的道路從未如此清晰。

I believe our risk profile has never been lower. And I believe our transparency allows all of you to see this as well. Let me walk you through where we are today on bringing Anaphylm to market here in the US as well as around the world. We believe we have a very clear and achievable set of instructions from the FDA on resubmission of our NDA.

我相信我們的風險概況從未如此之低。我也相信，我們的透明度讓各位同樣能看見這一點。讓我帶各位了解我們目前在美國以及全球推動 Anaphylm 上市的進展。我們相信，FDA 已就我們重新提交 NDA 提供了一套非常清楚且可達成的指示。

We have submitted our Type A Meeting request and expect to have a discussion with the FDA within the next 30 days. We have already selected our clinical research organizations for both the human factor study and PK study and continue to prepare for dosing. We are agreeing to everything the FDA requested, with one minor clarification on the arms required for the PK study. We have already modified our packaging to make the pouch easier to open, and this has no impact on stability or durability.

我們已提交 Type A 會議申請，並預期在未來 30 天內與 FDA 進行討論。我們已為人因研究與 PK 研究選定臨床研究機構（CRO），並持續為給藥作準備。我們同意 FDA 所要求的一切事項，僅就 PK 研究所需的試驗組別有一項小幅釐清。我們已修改包裝，使袋裝更容易開啟，且不影響穩定性或耐久性。

We are reiterating today our commitment to filing our resubmission in the third quarter of this year. You can also find more specific details on our program, including pictures of the revised packaging, in our supplemental materials found on our website.

我們今天重申承諾，將於今年第三季提交重新送件。您也可在我們官網的補充資料中找到更具體的計畫細節，包括修訂後包裝的圖片。

While it's great to have a clear path and plan, you also need the right team, and I am fortunate that we have a fantastic development team here at Aquestive, with the recent addition of Dr. Matt Greenhawt, a world-renowned allergist and this year's recipient of the prestigious Distinguished Clinician Award by the American Academy of Allergy, Asthma and Immunology, AAAAI, and the addition late last year of Dr. Matthew Davis, a seasoned development leader from large established organizations, we have the clinical expertise to efficiently conduct our development studies, interact effectively with the FDA, and appropriately inform the medical community of our clinical results. This is by far the strongest clinical team Aquestive has ever had.

雖然擁有清晰的路徑與計畫很重要，但同樣需要合適的團隊。我很幸運，我們在 Aquestive 擁有出色的開發團隊；近期加入的 Matt Greenhawt 醫師是世界知名的過敏專家，並獲得美國過敏、氣喘與免疫學會（AAAAI）今年頒發的崇高「傑出臨床醫師獎」；此外，去年底加入的 Matthew Davis 醫師則是來自大型成熟組織、經驗豐富的開發領導者。憑藉這些加入，我們具備臨床專業能力，能有效率地執行開發研究、與 FDA 有效互動，並適切地向醫療界傳達我們的臨床結果。這無疑是 Aquestive 史上最強的臨床團隊。

In fact, it will be important that we get our scientific and medical information out to the community as broadly and deeply as possible this year. That is why in addition to Dr. Greenhawt joining us, we are more than doubling the size of our medical affairs organization. This will allow us to attend more conferences, educate more physicians on our data, and provide the community with more scientific publications in the coming months.

事實上，今年我們必須盡可能廣泛且深入地向社群傳遞我們的科學與醫學資訊。因此，除了 Greenhawt 醫師加入之外，我們也將醫學事務組織的規模擴增至兩倍以上。這將使我們能參與更多會議、向更多醫師宣導我們的數據，並在未來數月為社群提供更多科學出版物。

This clinical and medical prowess also aligns with our work outside the US. We remain on track to file in Europe and Canada before the end of the year. We also will be meeting with the UK health authority, known as MHRA, in the coming weeks. We are confident that Anaphylm can benefit all humans, and we want to expand access to our product outside of the US as rapidly as possible.

這樣的臨床與醫學實力也與我們在美國以外的工作相呼應。我們仍按計畫在年底前於歐洲與加拿大提出申請。未來幾週我們也將與英國衛生主管機關（MHRA）會面。我們有信心 Anaphylm 能造福所有人類，並希望盡可能快速地將我們的產品擴大至美國以外的市場以提升可近性。

Now let's turn to the commercial side. Launching a prescription drug in the US is extremely difficult. It requires considerable capital, patience to work through the complexities of the payer world, and significant marketing efforts across a variety of channels. Similar to development, this takes having the right people.

接著談商業面。在美國推出處方藥極具挑戰。這需要相當的資本、在支付方體系的複雜性中耐心推進，以及透過多元渠道投入大量行銷資源。與開發工作類似，這也需要合適的人才。

As you may recall from my comments a month ago, Sherry Korczynski, our Chief Commercial Officer, and I made the decision to keep the core commercial leadership team intact following our CRL. That team continues to do great work and prepare for launch.

各位或許還記得我一個月前的評論：在收到 CRL 後，我與我們的首席商務長 Sherry Korczynski 決定維持核心商業領導團隊不變。該團隊持續表現出色，並為上市做準備。

This extra preparation time allows us to think bigger, and we are guiding today that we will launch with 50% more sales reps upon approval compared to our previous guidance. This means we expect to have 75 reps at launch versus the previous guidance of 50. Our planning process indicates we should be able to do this from a close to cash-neutral position by the end of 2027.

這段額外的準備時間讓我們能以更宏觀的角度思考；因此我們今天指引，獲准後上市時的業務代表人數將較先前指引增加 50%。這表示我們預期上市時將配置 75 名業務代表，而非先前指引的 50 名。我們的規劃流程顯示，到 2027 年底我們應能在接近現金收支兩平的狀態下達成此目標。

Speaking of cash, as stated before, launching a drug takes tremendous amounts of capital. Accessing this capital means making sure you have the right investors who believe in your product, your story, and your team. That's why we were excited to announce today that RTW has extended their revenue sharing agreement with us to consummate at any time before June 30, 2027, and has also agreed to invest additional capital in the company. We appreciate the faith put in us by the RTW team and, like all of our investors and shareholders, take this responsibility seriously. This, along with our cash guidance that Ernie will discuss in a few minutes, we believe positions us well for a potential launch.

談到現金，如先前所述，推出一款藥物需要龐大的資本。取得這些資本意味著要確保你擁有合適的投資人，他們相信你的產品、你的故事以及你的團隊。因此，我們很高興在今天宣布，RTW 已將其與我們的收益分成協議延長，可於 2027 年 6 月 30 日之前的任何時間完成交割，並且也同意向公司投入額外資本。我們感謝 RTW 團隊對我們的信任，並且如同我們所有投資人與股東一樣，嚴肅看待這份責任。我們相信，這一點再加上 Ernie 將在幾分鐘後討論的現金指引，使我們在潛在上市方面具備良好條件。

In terms of the underlying allergy market, we continue to see overall prescription growth. EpiPen and generic auto-injectors grew by approximately 5% in the fourth quarter of 2025. And the overall market grew by just over 9%. Importantly, we also continue to see a market that seems to be waiting for the first oral epinephrine product. Over 90% of prescriptions remain with auto-injectors.

就整體過敏市場而言，我們持續看到處方量整體成長。EpiPen 與學名藥自動注射器在 2025 年第四季約成長 5%。而整體市場成長略高於 9%。重要的是，我們也持續看到市場似乎正在等待第一個口服腎上腺素產品。超過 90% 的處方仍以自動注射器為主。

And obviously, the entire market continues to use medical devices. As I've stated in the past, we believe seeing is believing with our oral medication. When patients have the physical film in front of them, our data indicates they will almost always choose the film over auto-injectors and nasal sprays. Given the potential near-term launch of Anaphylm in the US, if approved by the FDA, we will continue to both simplify and grow our overall business where possible.

而且顯然，整個市場仍持續使用醫療器材。如我過去所述，我們相信對於我們的口服藥物，「眼見為憑」。當病患面前有實體薄膜時，我們的數據顯示，他們幾乎總是會選擇薄膜而非自動注射器與鼻噴劑。鑑於 Anaphylm 在美國可能於短期內上市（若獲 FDA 核准），我們將在可行之處持續簡化並擴大我們的整體業務。

From a litigation standpoint, this means we will continue to seek ways to simplify our workload while also appropriately defending our business. In December, we reached a settlement agreement in a nine-year long defamation lawsuit brought by a competitor, and I am pleased to remove this distraction from the business. This marks the fourth lawsuit we have been able to have withdrawn, get thrown out of court or reasonably settle over the last four years.

從訴訟角度來看，這意味著我們將持續尋求方法以簡化工作負擔，同時也適當地捍衛我們的業務。12 月，我們就一宗由競爭對手提起、長達九年的誹謗訴訟達成和解協議，我很高興能將這項干擾自業務中移除。這是過去四年來，我們得以撤回、被法院駁回或以合理條件和解的第四起訴訟。

We are also guiding that due to the timing of a potential Anaphylm launch, our initial focus with Libervant will be licensing the product in the US We have several parties already interested and actively engaged in discussions. We will keep you updated on this as the year progresses. We continue to believe Libervant is a tremendous product that can meaningfully improve patients' lives. We also note that the two nasal spray products available for the treatment of seizure clusters are forecasted to exceed over $400 million in sales this upcoming year.

我們也指引指出，由於 Anaphylm 潛在上市時點的關係，我們對 Libervant 的初期重點將是於美國進行產品授權。目前已有數個對象表達興趣並積極參與討論。隨著年度進展，我們將持續向各位更新。我們仍相信 Libervant 是一項極具價值的產品，能夠實質改善病患生活。

We continue to progress nicely with multiple parties in Europe for a license of Anaphylm and expect to use a licensing approach for that market. Finally, we also have our eyes towards the long-term future of the company. We continue to believe in a long-term, multiproduct potential of AdrenaVerse, our prodrug epinephrine platform, we successfully opened an IND for AQST-108 in December 2025, completed dosing of our initial safety study last month and expect to have top line clinical data in the near future. We will keep you informed on this program as we move forward.

我們在歐洲與多方就 Anaphylm 授權持續取得良好進展，並預期該市場將採取授權策略。最後，我們也著眼於公司的長期未來。我們持續相信 AdrenaVerse（我們的前藥腎上腺素平台）具備長期、多產品的潛力；我們已於 2025 年 12 月成功為 AQST-108 開立 IND，上月完成初始安全性研究的給藥，並預期在不久的將來取得主要臨床數據。隨著計畫推進，我們將持續向各位通報此項目。

In summary, now is a great time for Aquestive. We have a clear path to market for Anaphylm; we have a clear path to the necessary capital to launch Anaphylm if approved by the FDA; we have the right clinical, regulatory and commercial leaders to effectively execute on our strategy; we are focused on out-licensing activities for Libervant and ex US for Anaphylm; and we continue to progress our long-term pipeline.

總結而言，現在對 Aquestive 來說是個很好的時機。我們對 Anaphylm 有清晰的上市路徑；若獲 FDA 核准，我們也有清晰的必要資本取得路徑以推動 Anaphylm 上市；我們擁有合適的臨床、法規與商業領導團隊以有效執行策略；我們專注於 Libervant 的對外授權活動以及 Anaphylm 的美國以外授權；同時我們也持續推進長期研發管線。

With that, I will turn the call over to Ernie.

接下來，我把電話會議交給 Ernie。

Thank you, Dan, and good morning, everyone. By now, you will 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 fourth quarter 2025 and full year 2025 results in the Q&A.

謝謝你，Dan，各位早安。到目前為止，各位應該已在昨晚發布的財報新聞稿中看到我們的財務結果。如同我們一貫做法，我們將在問答環節中討論大部分與 2025 年第四季及 2025 全年業績相關的內容。

During 2025, we made great progress in positioning Aquestive for future success, including submitting the NDA for Anaphylm, the first and only noninvasive, orally delivered epinephrine products, if approved by the FDA; closing an $85 million equity raise from high-quality institutional healthcare investors; secured $75 million in revenue interest financing from RTW upon approval of Anaphylm; and ended 2025 with $121 million, with cash runway to support costs associated in preparing for the Anaphylm NDA resubmission, including the new human factors validation study and supportive PK study, pre-commercial infrastructure costs to increase awareness of Anaphylm through the execution of its medical affairs strategy, including presenting scientific data at medical forums throughout 2026, planned regulatory submissions in Canada and in the EU, and the AQST-108 Phase 1 clinical trial.

在 2025 年，我們在為 Aquestive 的未來成功奠定基礎方面取得重大進展，包括提交 Anaphylm 的 NDA；若獲 FDA 核准，Anaphylm 將是第一且唯一的非侵入式口服腎上腺素產品；完成來自高品質機構型醫療保健投資人的 8,500 萬美元股權募資；在 Anaphylm 獲核准後，自 RTW 取得 7,500 萬美元的收益權融資；並在 2025 年底持有 1.21 億美元現金，具備足以支應與準備 Anaphylm NDA 重新提交相關成本的現金跑道，包括新的人因驗證研究與支持性 PK 研究、為透過執行醫學事務策略以提升 Anaphylm 認知度而投入的上市前基礎建設成本（包括於 2026 年在各醫學論壇發表科學數據）、在加拿大與歐盟的規劃法規申請，以及 AQST-108 第一階段臨床試驗。

As outlined in the press release issued last night after market close, we announced an extension until June 30, 2027, of our agreement with RTW. This extension secures the availability of the revenue interest financing to support the commercial launch of Anaphylm if approved by the FDA. RTW has also agreed to an additional strategic investment of $5 million in Aquestive, showing continued confidence in the company.

如同昨晚收盤後發布的新聞稿所述，我們宣布將與 RTW 的協議延長至 2027 年 6 月 30 日。此項延長確保在 Anaphylm 若獲 FDA 核准時，可取得收益權融資以支援其商業上市。RTW 也同意對 Aquestive 額外進行 500 萬美元的策略性投資，展現其對公司的持續信心。

Now let's turn to the recap of our quarterly and full year financial results. Total revenues increased to $13 million in the fourth quarter 2025, from $11.9 million in the fourth quarter 2024. This 10% increase in revenue was primarily driven by increases in manufacture and supply revenue.

現在讓我們回顧季度與全年財務結果。2025 年第四季總營收增至 1,300 萬美元，較 2024 年第四季的 1,190 萬美元增加。這 10% 的營收成長主要由製造與供應營收增加所帶動。

Manufacturing and supply revenue increased to $12 million in the fourth quarter 2025 from $10.7 million in the fourth quarter 2024, primarily due to increases in Suboxone revenues and Ondif revenues. Excluding the impact of onetime recognition of deferred revenues during the full year 2024, total revenues decreased by $1.5 million or 3% to $44.5 million for the full year 2025. As a reminder, the onetime recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements.

2025 年第四季製造與供應營收增至 1,200 萬美元，高於 2024 年第四季的 1,070 萬美元，主要由 Suboxone 與 Ondif 營收增加所致。若排除 2024 全年一次性認列遞延收入的影響，2025 全年總營收減少 150 萬美元（或 3%）至 4,450 萬美元。提醒各位，前一年度一次性認列遞延收入係因授權與供應協議終止所致。

Including the deferred revenue recognized in the prior year, total revenues decreased to $44.5 million for the full year 2025 from $57.6 million for the full year 2024. Manufacture and supply revenue increased to $40.2 million for the full year 2025 from $40 million for the full year 2024, primarily due to increases in Ondif revenues, partially offset by decreases in Suboxone revenues.

若包含前一年度所認列的遞延收入，2025 全年總營收降至 4,450 萬美元，低於 2024 全年的 5,760 萬美元。2025 全年製造與供應營收增至 4,020 萬美元，高於 2024 全年的 4,000 萬美元，主要由 Ondif 營收增加所帶動，但部分被 Suboxone 營收下降所抵銷。

R&D expenses decreased to $3.2 million in the fourth quarter 2025 from $4.9 million in the fourth quarter 2024. The decrease in R&D expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anaphylm development program and a decrease in share-based compensation. R&D expenses decreased to $17.2 million for the full year 2025 from $20.3 million in the full year 2024. The decrease in R&D expenses was primarily due to lower clinical trial costs associated with the continued advancement of the Anaphylm development program, partially offset by increases in product research expenses and share-based compensation.

2025 年第四季研發費用降至 320 萬美元，低於 2024 年第四季的 490 萬美元。研發費用下降主要由於與 Anaphylm 開發計畫持續推進相關的臨床試驗成本降低，以及股份基礎給付減少。2025 全年研發費用降至 1,720 萬美元，低於 2024 全年的 2,030 萬美元。研發費用下降主要由於與 Anaphylm 開發計畫持續推進相關的臨床試驗成本較低，但部分被產品研究費用與股份基礎給付增加所抵銷。

Excluding onetime legal expenses, selling, general and administrative expenses increased to $19.6 million in the fourth quarter 2025 from $16 million in the fourth quarter 2024. Including the onetime legal expenses, selling, general and administrative expenses increased to $32.8 million in the fourth quarter 2025 from $16 million in the fourth quarter 2024, primarily due to higher legal expenses of approximately $13.6 million, higher commercial spending of approximately $3.7 million in preparation for the launch of Anaphylm, higher personnel expenses of approximately $0.8 million and higher share-based compensation of approximately $0.2 million, partially offset by lower severance expenses of approximately $1.7 million and lower regulatory in-licensing fees of approximately $0.5 million.

排除一次性法律費用後，2025 年第四季的銷售、一般及行政費用由 2024 年第四季的 1,600 萬美元增加至 1,960 萬美元。若包含一次性法律費用，2025 年第四季的銷售、一般及行政費用由 2024 年第四季的 1,600 萬美元增加至 3,280 萬美元，主要由於法律費用增加約 1,360 萬美元、為 Anaphylm 上市做準備的商業支出增加約 370 萬美元、人員費用增加約 80 萬美元，以及以股份為基礎之酬勞增加約 20 萬美元；部分被資遣費用減少約 170 萬美元及法規引進授權費用降低約 50 萬美元所抵銷。

Excluding onetime legal expenses, selling, general and administrative expenses increased to $66.6 million for the full year 2025 from $50.2 million for the full year 2024. Including onetime legal expenses, selling, general and administrative expenses increased to $79.8 million for the full year 2025 from $50.2 million for the full year 2024. The increase primarily represents higher legal fees of approximately $14.3 million, higher commercial spending of approximately $9.6 million in preparation for the launch of Anaphylm.

排除一次性法律費用後，2025 全年銷售、一般及行政費用由 2024 全年的 5,020 萬美元增加至 6,660 萬美元。若包含一次性法律費用，2025 全年銷售、一般及行政費用由 2024 全年的 5,020 萬美元增加至 7,980 萬美元。該增加主要反映法律費用增加約 1,430 萬美元，以及為 Anaphylm 上市做準備的商業支出增加約 960 萬美元。

The Anaphylm PDUFA fee of $4.3 million, higher personnel expenses of approximately $1.9 million, higher regulatory expenses related to Anaphylm of approximately $1 million and higher share-based compensation expenses of approximately $0.9 million, partially offset by decreases in severance expenses of approximately $2.8 million and lower insurance expenses of approximately $0.6 million.

Anaphylm 的 PDUFA 費用為 430 萬美元，人員費用增加約 190 萬美元、與 Anaphylm 相關的法規費用增加約 100 萬美元，以及以股份為基礎之酬勞費用增加約 90 萬美元；部分被資遣費用減少約 280 萬美元及保險費用降低約 60 萬美元所抵銷。

Excluding onetime legal expenses, Aquestive's net loss for the fourth quarter of 2025 was $18.7 million or $0.15 for both basic and diluted loss per share, compared to the net loss for the fourth quarter of 2024 of $17.1 million or $0.19 for both basic and diluted loss per share.

排除一次性法律費用後，Aquestive 於 2025 年第四季的淨損為 1,870 萬美元，基本及稀釋每股虧損均為 0.15 美元；相較之下，2024 年第四季淨損為 1,710 萬美元，基本及稀釋每股虧損均為 0.19 美元。

Including onetime legal expenses, Aquestive's net loss for the fourth quarter 2025 was $31.9 million or $0.26 for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million or $0.19 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses and manufacture and supply expenses, partially offset by decreases in research and development expenses and increases in revenue and interest income and other income.

若包含一次性法律費用，Aquestive 於 2025 年第四季的淨損為 3,190 萬美元，基本及稀釋每股虧損均為 0.26 美元；相較之下，2024 年第四季淨損為 1,710 萬美元，基本及稀釋每股虧損均為 0.19 美元。淨損增加主要由銷售、一般及行政費用以及製造與供應費用增加所帶動，部分被研發費用下降以及營收、利息收入與其他收入增加所抵銷。

Excluding onetime legal expenses, Aquestive's net loss for the full year 2025 was $70.6 million or $0.66 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million or $0.51 for both basic and diluted loss per share.

排除一次性法律費用後，Aquestive 於 2025 全年的淨損為 7,060 萬美元，基本及稀釋每股虧損均為 0.66 美元；相較之下，2024 全年淨損為 4,410 萬美元，基本及稀釋每股虧損均為 0.51 美元。

Including onetime legal expenses, Aquestive's net loss for the full year 2025 was $83.8 million or $0.78 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million or $0.51 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses and manufacturer and supply expenses and decreases in revenue, partially offset by decreases in R&D expenses and increases in interest income and other income.

若包含一次性法律費用，Aquestive 於 2025 全年的淨損為 8,380 萬美元，基本及稀釋每股虧損均為 0.78 美元；相較之下，2024 全年淨損為 4,410 萬美元，基本及稀釋每股虧損均為 0.51 美元。淨損增加主要由銷售、一般及行政費用以及製造商與供應費用增加、以及營收下降所帶動，部分被研發費用下降以及利息收入與其他收入增加所抵銷。

Excluding onetime legal expenses, non-GAAP adjusted EBITDA loss was $14.1 million in the fourth quarter 2025, compared to non-GAAP adjusted EBITDA loss of $11 million in the fourth quarter 2024. Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses and onetime legal expenses, was $10.8 million in the fourth quarter 2025, compared to non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $6.6 million in the fourth quarter 2024.

排除一次性法律費用後，2025 年第四季非 GAAP 調整後 EBITDA 虧損為 1,410 萬美元，較 2024 年第四季非 GAAP 調整後 EBITDA 虧損 1,100 萬美元增加。非 GAAP 調整後 EBITDA 虧損（排除調整後研發費用及一次性法律費用）於 2025 年第四季為 1,080 萬美元，較 2024 年第四季非 GAAP 調整後 EBITDA 虧損（排除調整後研發費用）之 660 萬美元增加。

Excluding onetime legal expenses, Aquestive's non-GAAP adjusted EBITDA loss was $49.7 million for the full year 2025, compared to non-GAAP adjusted EBITDA loss of $23 million for the full year 2024. Non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses and onetime legal expenses, was $34.4 million for the full year 2025, compared to non-GAAP adjusted EBITDA loss, excluding adjusted R&D expenses, of $4 million for the full year 2024. As of December 31, 2025, cash and cash equivalents were $121.2 million.

排除一次性法律費用後，Aquestive 於 2025 全年的非 GAAP 調整後 EBITDA 虧損為 4,970 萬美元，較 2024 全年非 GAAP 調整後 EBITDA 虧損 2,300 萬美元增加。非 GAAP 調整後 EBITDA 虧損（排除調整後研發費用及一次性法律費用）於 2025 全年為 3,440 萬美元，較 2024 全年非 GAAP 調整後 EBITDA 虧損（排除調整後研發費用）之 400 萬美元增加。截至 2025 年 12 月 31 日，現金及約當現金為 1.212 億美元。

As outlined in the press release issued last night after market close, our outlook for 2026 is total revenue of $46 million to $50 million and non-GAAP adjusted EBITDA loss of $30 million to $35 million. We expect to end 2026 with approximately $70 million, excluding any additional proceeds from RTW or out-licensing transactions.

如同昨晚收盤後發布的新聞稿所述，我們對 2026 年的展望為：總營收 4,600 萬至 5,000 萬美元，以及非 GAAP 調整後 EBITDA 虧損 3,000 萬至 3,500 萬美元。我們預期 2026 年底約有 7,000 萬美元（不含來自 RTW 或對外授權交易的任何額外收益）。

Our non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for Anaphylm, continued pre-commercial infrastructure spending for Anaphylm, clinical trial costs for AQST-108, and regulatory applications for Anaphylm in Canada and the EU. Current guidance does not include costs associated with the sales and marketing of Anaphylm, if approved by the FDA.

我們 2026 年非 GAAP 調整後 EBITDA 虧損指引包含與 Anaphylm NDA 重新遞交相關的成本、Anaphylm 持續的商業化前基礎建設支出、AQST-108 的臨床試驗成本，以及 Anaphylm 在加拿大與歐盟的法規申請。目前指引不包含 Anaphylm（若獲 FDA 核准）之銷售與行銷相關成本。

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

接下來，我把電話交回給接線員，開放提問。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

(接線員指示) Roanna Ruiz，Leerink Partners。

So a couple for me. Starting with the Type A Meeting with the FDA. I just want to confirm I heard it correctly, it sounds like you submitted a request, but it has not been scheduled yet, but that could happen soon. And secondly, could you elaborate a bit on your main goals going into this meeting? And is there any additional information you need to prepare for the FDA for this meeting?

我有幾個問題。先從與 FDA 的 Type A 會議開始。我想確認我是否聽對了：聽起來你們已提交會議申請，但尚未排定時間，不過可能很快就會安排。第二，能否再多談一些你們參加這次會議的主要目標？以及為了這次會議，你們是否需要為 FDA 準備任何額外資訊？

Sure. Roanna, I'll hand it over to Melina in a second here. Just a couple of basic things. We have submitted. We expect that meeting to happen shortly.

當然。Roanna，我等一下把問題交給 Melina。先說幾個基本事項。我們已經提交了。我們預期該會議將在近期舉行。

I'll let Melina walk you through kind of the, I'll call it, the contract that the FDA has to uphold.

我會讓 Melina 帶你了解一下，我稱之為 FDA 必須遵守的「時程規範」。

From a goals perspective, we don't need a lot out of the meeting. And I'll also let Melina elaborate a little bit on that.

就目標而言，我們不需要從這次會議取得太多。我也會讓 Melina 再補充說明一些。

Thank you, Dan. So in terms of the timing, the FDA guidelines state that the agency should meet with the sponsor within 30 days from the date that we submitted our meeting request and our briefing book. So if they go according to those timelines, we should be able to meet with them towards the end of this month or very early April.

謝謝你，Dan。就時程而言，FDA 指引指出，機構應在我們提交會議申請與簡報資料（briefing book）之日起 30 天內與申請方會面。因此，如果他們依照該時程，我們應可在本月底或 4 月初非常早的時間與他們會面。

In terms of the goals of the meeting, we shared with them our briefings that outlined our commitment to conduct the two studies that they requested in the CRL. And we also asked questions to ensure that we walk away essentially from this meeting with clear alignment on how best to execute for the purposes of the research.

就會議目標而言，我們在提交的簡報中說明了我們承諾執行 CRL 中他們要求的兩項研究。我們也提出問題，以確保我們基本上能在會後對如何以研究目的最佳方式執行，取得明確一致的共識。

Right. And Roanna, I would just remind you and those on the call, it's been 31 days since we received our CRL. And in those 31 days, we've not only written the protocols, contracted our CRLs, changed our packaging, written a briefing book, resubmitted that briefing book to the FDA, but obviously also brought on a new Chief Medical Officer and redesigned our deal with RTW. So we feel really good that we are on track in every way, and the Type A Meeting is just one part of that.

沒錯。而且 Roanna，我想提醒你以及電話上的各位，距離我們收到 CRL 已經 31 天了。在這 31 天裡，我們不僅撰寫了試驗方案、簽約了我們的 CRL 相關合作、變更了包裝、撰寫了一本簡報資料（briefing book）、並將該簡報資料重新提交給 FDA，而且很明顯地也延攬了新的首席醫療官，並重新設計了我們與 RTW 的交易。因此我們對於各方面都按計畫推進感到非常有信心，而 Type A 會議只是其中的一部分。

Yes. That's super helpful. And a follow-up on that, I think you mentioned doing a modification to the proposed protocol that the FDA mentioned in the CRL, or could you just explain a bit more about that? Is it relatively straightforward? And how should we think about it moving -- with the FDA interaction with you coming up?

是的。這非常有幫助。另外追問一下，我想你提到會對 FDA 在 CRL 中提到的擬議試驗方案做一些修改，你能再多解釋一點嗎？這是否相對直接？以及在接下來你們即將與 FDA 互動的情況下，我們應該如何看待後續推進？

Yes. That's, in my view, so we won't get into the exact question, we'll obviously be able to share that in a few weeks here, but that's literally the only question we have for the FDA. And we're fine with the answer either way. So the minor modification, Matthew Davis and his team just want to make sure they understand how the FDA is thinking about it. And once we have the answer, we'll -- there's nothing more we need.

是的。依我看，我們不會在這裡深入到具體問題內容；我們顯然會在幾週後分享，但那確實就是我們對 FDA 唯一的問題。而且不論答案是哪一種，我們都可以接受。所以這個小幅修改，Matthew Davis 和他的團隊只是想確保他們理解 FDA 對此的思考方式。一旦我們拿到答案，我們就——沒有其他需要的了。

Kristen Kluska, Cantor Fitzgerald.

Kristen Kluska，Cantor Fitzgerald。

I have a couple as well. On the RTW, great to see you extended that option. I noticed that the language was through the end of June next year. You had told us that your expectation is that it would be a six-month review upon submitting. Is the timeline here just to give you a little bit of buffer room on the back end? And then also, can you just confirm that it's still $75 million and that those terms haven't changed?

我也有幾個問題。關於 RTW，很高興看到你們延長了那個選擇權。我注意到條款文字是到明年六月底。你們之前告訴我們，你們的預期是提交後會有六個月的審查。這個時間安排是否只是為了在後端多留一些緩衝？另外，也請你們確認仍然是 7,500 萬美元，且那些條款沒有改變？

Yes. The second question, I'll turn it over to Ernie in a second, but in terms of the timing of why June 30, 2027, that's easy, because it's easy to modify the one year. We in no way expect to need anywhere near that amount of time to bring our product to market. But it's just an easy way to update the contract. But I'll let Ernie talk about any other changes.

是的。第二個問題我等一下交給 Ernie 回答；至於為什麼是 2027 年 6 月 30 日，這很簡單，因為把一年期做修改很容易。我們完全不預期需要接近那麼長的時間才能把產品推向市場。但這只是更新合約的一個簡便方式。不過我讓 Ernie 談談是否還有其他變更。

Kristen, yes, we can confirm that none of the terms of the agreement with RTW have changed. I think the important thing is here with the additional purchase of $5 million. We appreciate their continued support as we move forward through the process this year of resubmission and hopefully an approval and launching the product next year.

Kristen，是的，我們可以確認與 RTW 的協議條款沒有任何改變。我認為這裡重要的是額外購買 500 萬美元。我們感謝他們在我們今年推進重新提交流程、並希望獲得核准、以及明年推出產品的過程中持續支持。

Okay. And then I know Sherry and team have been doing a lot of work in terms of mapping territories this past year. So I wanted to ask a little bit more on this decision to add 50% more sales reps. Was this just driven by seeing new pockets where you think you would need more boots on the ground? Or is there anything specific that led to this decision as well as the specific percent more that you'll be adding?

好的。另外我知道 Sherry 和團隊在過去一年做了很多區域劃分（territory mapping）的工作。所以我想再多問一下這個決定：把業務代表增加 50%。這是否只是因為你們看到一些新的區域/市場空間，認為需要更多前線人力？或者還有任何特定因素促成這個決定，以及為什麼是增加到這個特定百分比？

I'll let Sherry take that.

我讓 Sherry 來回答。

Kristen, thanks so much for asking this question. We're very excited about our decision. Why did we do it? We went back as we've been doing with all of our commercial work that we were preparing for launch, to say, how many more reps do we need to cover much deeper -- penetrate much deeper into the allergist market? And in the same regard, ensuring that we are also -- the reps will be calling on the pediatricians, the high decile pediatricians.

Kristen，非常感謝你問這個問題。我們對這個決定感到非常興奮。為什麼要這麼做？我們回頭檢視——就像我們在所有為上市做準備的商業化工作中一直在做的——我們需要多少更多的業務代表，才能更深入覆蓋——更深入滲透到過敏專科醫師（allergist）市場？同時也確保我們的業務代表也會拜訪兒科醫師，尤其是高十分位（high decile）的兒科醫師。

When we took a look at the reach and frequency that we're able to achieve by moving towards the approximately 75 reps, there are a couple of reasons why that made sense. One was, obviously, with smaller territories, it allows our reps to have greater efficiency as that will allow them not to have to travel hours to see all the important physicians. So one, it's greater efficiency.

當我們檢視把人力提升到約 75 位業務代表後所能達到的觸及率與拜訪頻率（reach and frequency），有幾個原因讓這樣做很合理。其中之一當然是，區域更小能讓業務代表更有效率，因為他們不必花好幾個小時奔波，才能見到所有重要的醫師。所以第一點是效率更高。

Two, it closes white space. So as I'm sure you can imagine, with 50 reps, we would have had a lot of white space. We would have handled that through inside sales reps. However, again, by moving to the 75 reps, it gives us much greater coverage.

第二點，它能填補白地（white space）。所以如你所想像，若只有 50 位業務代表，我們會有很多白地。我們原本會透過內勤銷售代表（inside sales reps）來處理。然而，再次強調，提升到 75 位業務代表能讓我們覆蓋面大幅提高。

And Kristen, I think you can see that our investment in the allergy community is growing in general. So it's not just the reps. But with Matt Greenhawt and the medical affairs team getting bigger as well, our ability to be out there with publications, you saw our presence at AAAAI last weekend, we are making sure we are front and center as we go into launch.

而且 Kristen，我想你也看得出來，我們對過敏社群的投入整體上正在增加。所以不只是業務代表。隨著 Matt Greenhawt 與醫藥事務（medical affairs）團隊也在擴編，我們在外部發表出版物的能力也提升；你也看到我們上週末在 AAAAI 的出席與能見度。我們正確保在進入上市階段時，我們能站在舞台中央。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So just a couple for me. One is maybe taking a step back, can you talk about how you settled on the trial design? And are you prepared to make any modifications to the design coming out of the meeting with the FDA, if necessary? Just wanted to get a window into your thought process in terms of how you designed the trial. So that's number one.

我這邊有幾個問題。第一個是，或許先退一步，你們能談談你們是如何敲定試驗設計的嗎？以及如果有需要，你們是否準備在與 FDA 的會議後對設計做任何修改？我想了解你們在設計試驗時的思考脈絡。這是第一個。

Number two is with the sales force -- the bigger sales force, wanted to ask how you're thinking about DTC. Are you taking -- are you going to take a more expansive approach to DTC? And that's particularly in the context of your competitor being fairly aggressive here. So I wanted to get your thoughts on that.

第二個是關於銷售團隊——更大的銷售團隊——我想問你們如何看待 DTC（直接面向消費者行銷）。你們是否會採取更擴張的 DTC 策略？尤其是在你們的競爭對手在這方面相當積極的背景下。所以想聽聽你們的看法。

And then lastly, on 108, real quick question. I think you made a comment in the press release about indication selection. So I just want to be clear, is it going to be alopecia areata, or are you thinking about other indications or maybe pivoting to something else? I just wanted to clarify on that.

最後，關於 108，很快一個問題。我記得你們在新聞稿中提到適應症選擇（indication selection）。所以我想確認一下，會是圓形禿（alopecia areata）嗎？還是你們在考慮其他適應症，或可能轉向別的方向？我只是想釐清這點。

Sure, David. So let me take the sales force DTC question first, and then I will hand it over to Matthew to talk about trial design, especially on the PK side and how we can be ready for any modifications if necessary.

當然，David。我先回答銷售團隊的 DTC 問題，然後我會把問題交給 Matthew，請他談談試驗設計，特別是 PK（藥物動力學）部分，以及如有需要我們如何準備好做任何修改。

So from a DTC perspective, we still believe that DTC is best served once you have a reasonable market share. And we also have a competitor, to your point, is spending a lot of money on DTC, which we see growing the overall market. So it's growing the auto-injector market. So we continue to believe, let the competitors spend money in that area. We focus on our touches directly with reps.

就 DTC 而言，我們仍然相信，一旦你擁有合理的市占率，DTC 才能發揮最佳效益。而且如你所說，我們也有競爭對手在 DTC 上投入大量資金，我們認為這是在擴大整體市場。也就是在擴大自動注射器（auto-injector）市場。因此我們仍然認為，就讓競爭對手在那個領域花錢。我們則專注於透過業務代表直接觸達。

Let me pass it over to Matthew on your question number one, which was a trial -- how we settled on our trials on if we have to make modifications.

讓我把你的第一個問題交給 Matthew 回答，也就是關於試驗——我們如何確定試驗設計，以及是否需要做修改。

Thank you very much for the question. We have the optionality of doing two things at the same time. So upon looking at the FDA's request, we have a trial design that's in line with what the information they want to seek. And we also believe, based on our 11 other PK trials that we've done, that we have enough information to categorize some of that information. And with the updated human factors research that we're going to do, we believe that maybe not all the arms are going to be necessary.

非常感謝你的提問。我們可以同時做兩件事，具備彈性選擇。因此，在檢視 FDA 的要求後，我們有一個符合他們希望取得資訊的試驗設計。同時，我們也相信，基於我們已完成的另外 11 項 PK 試驗，我們已經有足夠資訊來對其中部分資料進行歸類整理。再加上我們將進行更新的人因研究，我們認為或許不需要所有的試驗組別。

But if the FDA at the meeting invites these trial design to be exactly what they asked in the CRL, we are also ready to do that. So at the end of the FDA meeting, we're going to have the clarity for the trial design. We already have protocols to take optionality into account. And we will meet our commitments that Dan has already stated for the finishing of the trial and the resubmission of Anaphylm.

但如果 FDA 在會議上希望試驗設計完全依照他們在 CRL 中所要求的內容，我們也已準備好照做。因此，在 FDA 會議結束時，我們將能清楚確定試驗設計。我們已經有能納入彈性選項的試驗方案。而且我們會履行 Dan 先前所提到的承諾，完成試驗並重新提交 Anaphylm。

And let's -- I'll actually stick with Matthew here for the third one, which is the indication selection for 108. I will say alopecia areata remains that the indication we're focused on, but Matthew can give us his thoughts on as we go through the development process, if there are other opportunities we might see.

另外——第三個問題我也先讓 Matthew 來回答，也就是 108 的適應症選擇。我想先說，圓形禿（alopecia areata）仍然是我們聚焦的適應症，但 Matthew 可以分享在開發過程中，若看到其他機會，他的看法。

I'm going to elaborate more once we've got the results of the current trial that we've done. But the 50,000-foot view, not only did we look at alopecia areata, we also looked at healthy normal patients and looking at the products pharmacokinetics and safety and other factors like proteomics, this will help inform us on future indications. So more to come on that. But we're making sure we have optionality to continue on with alopecia areata and also look at other topical indications that 108 would be designed for.

等我們拿到目前已完成的試驗結果後，我會再更詳細說明。但從更宏觀的角度來看，我們不僅研究了圓形禿，也研究了健康正常受試者，並評估產品的藥物動力學與安全性，以及像是蛋白質體學等其他因素，這些都將幫助我們判斷未來的適應症方向。所以後續還會有更多資訊。但我們會確保保有彈性，既能持續推進圓形禿，也能探索 108 所設計適用的其他外用適應症。

Francois Brisebois, LifeSci Capital.

Francois Brisebois，LifeSci Capital。

I was just wondering, in terms of the added reps here, the 50% more reps, can you remind us when you -- the timing of the hiring here? Is this kind of a post-approval or pre? Or just remind us what you're thinking?

我想請教一下，關於這裡新增的業務代表，也就是多 50% 的代表，你能否提醒我們你們招募的時間點？這是偏向核准後才做，還是核准前？或請再說明一下你們的想法？

Yes. Thanks for the question. Yes, we will continue to follow the same path that we were prepared for a launch this year. We will be interviewing and going through the process, so that once -- with candidates, and so that once we do have approval, then we would flip them immediately to full-time employees. So think about it the same way, contingent offers go out and we're ready to go upon launch.

好的。謝謝你的問題。是的，我們會延續原本的路徑——我們先前就是以今年上市做準備。我們會進行面試並推進流程，與候選人接洽，這樣一旦獲得核准，我們就能立刻把他們轉為全職員工。所以可以用同樣的方式理解：我們會先發出有條件錄用通知，並在上市時隨時就緒。

And Frank, I'll just add to Sherry's comments, just like before, that doesn't delay our launch at all. So there's a natural period of a few weeks after approval, as you know, where the supply chain has to kick in. And Sherry and her team have done a great job of being ready to strike during that period and make sure we have all of our reps ready to go by the end of that supply chain work.

Frank，我補充 Sherry 的說法：就像之前一樣，這完全不會延後我們的上市。如你所知，核准後通常會有幾週的自然期間，供應鏈需要啟動。Sherry 和她的團隊在這段期間已做得非常到位，隨時準備出擊，並確保在供應鏈作業結束時，我們所有業務代表都能就位。

Okay. Great. And then if I could follow up, just any updates on the citizens petition? Where does that stand? And then maybe if you can also touch on -- you were just at AAAAI, I assume it was a busy weekend. I was just wondering any takeaways from your perspective on how AAAAI went for Aquestive.

好的。很好。那我可以追問一下嗎：公民請願（citizens petition）有沒有任何更新？目前進展到哪裡？另外也請談談——你們剛參加 AAAAI，我想那應該是個很忙的週末。我想了解從你們的角度，AAAI 對 Aquestive 來說有哪些重點收穫？

Sure. Yes. So the citizen petition that was filed by a competitor was denied by the FDA last week, which to us, obviously, it was what we expected, but it's just -- it's another validating point for our data package. So in addition to the strong outcome and the derisking event you saw out of the CRL where it's focused on human factors, we also now see just a matter of a couple of weeks later a moment where the FDA is once again validating the strength of our package.

當然。是的。競爭對手提出的公民請願上週已被 FDA 否決；對我們而言，這當然符合我們的預期，但這也再次驗證了我們資料套件的可信度。因此，除了你在 CRL 中看到的強勁結果與去風險事件（其重點聚焦在人因），我們也在短短幾週後再次看到 FDA 重新肯定我們資料套件的強度。

So we feel really good about where we are with the FDA, especially from a clinical perspective. As you heard from the team, we're on track and we're ready to go.

所以我們對目前與 FDA 的互動狀態感到非常有信心，尤其是在臨床面向。如同你從團隊那裡聽到的，我們進度如期，並且已準備就緒。

In terms of AAAAI, which was last weekend, for those who are not familiar, and that is the biggest allergy conference in terms of attendance in a year. My biggest learning, and I'll toss it over to Sherry in a second too -- you know what, let's actually let Matt Greenhawt join in as well. So in a second, I'll pass it over to Matt instead of Sherry.

至於 AAAAI，也就是上週末的會議，對不熟悉的人來說，那是年度參與人數最多的過敏相關大型會議。我最大的收穫——我等一下也會請 Sherry 補充——你知道嗎，我們也讓 Matt Greenhawt 一起加入。所以我等一下會把問題交給 Matt，而不是 Sherry。

But from my perspective, what I heard consistently were two things. One, the allergist community believes in our ability to get to approval, given what was in the CRL. And two, they can't wait for our product. So very excited on both those fronts. So Matt, maybe you could give a couple of your thoughts.

但就我個人觀察，我持續聽到兩件事。第一，過敏專科社群相信我們有能力獲得核准，考量 CRL 的內容。第二，他們迫不及待想要我們的產品。所以這兩方面都讓人非常振奮。Matt，也許你可以分享幾點你的看法。

As usual, the AAAAI is a very busy and intense meeting. There's a lot of allergists, not only from the US, but globally, so it's a good draw. What I observed was a lot of excitement and curiosity about a new option for treating patients. As a practicing allergist, something like this adds a lot of potential to how we can observe patients. So to be able to interact with allergists and other people coming up to the booth and seeing us walking through the halls, the feedback I think is very consistent with what Dan just said, that there's excitement, there's curiosity.

一如往常，AAAI 是一個非常忙碌且密集的會議。參與的過敏專科醫師很多，不僅來自美國，也來自全球，因此吸引力很強。我觀察到大家對於治療病患的新選項充滿興奮與好奇。以一位執業中的過敏專科醫師來說，這樣的產品為我們觀察與管理病患帶來很大的潛力。因此，能與過敏專科醫師互動，或是有人走到攤位、在走廊遇到我們並交流，我認為回饋與 Dan 剛才說的非常一致：大家很興奮，也很好奇。

So it's exciting. In a year from now, I think it will be even more exciting.

所以這令人振奮。我想一年後會更令人振奮。

Andreas Argyrides, Oppenheimer.

Andreas Argyrides，Oppenheimer。

A couple from us here. So how are you viewing the requirements of the PK study is diverging from previous PK studies, including chewing and with or without water intake? How are you thinking about addressing the FDA's concerns around tolerability despite what you point to are minimal cases? And you recently presented additional data at AAAAI around diastolic blood pressure, citing no dip there? Can you elaborate on the importance of these data with regards to the FDA?

我們這邊有幾個問題。你們如何看待這次 PK 研究的要求與先前的 PK 研究出現差異，包括咀嚼以及是否搭配飲水？對於 FDA 對耐受性（tolerability）的疑慮，你們打算如何回應，儘管你們指出相關案例非常少？另外，你們最近在 AAAAI 提出了關於舒張壓的額外資料，指出沒有出現下降（no dip）？你能否說明這些資料對 FDA 而言的重要性？

Sure, Andreas. So I'll spread the well with these three questions. I'll have Matthew in a second to talk about the requirements from PK versus prior, including chewing. I'll ask Matt to talk about diastolic blood pressure, and then I'll finish up on tolerability. But Matt, why don't you start?

當然可以，Andreas。這三個問題我會分開回答。我會先請 Matthew 談談 PK 要求相較於先前研究（包括咀嚼）的差異。我會請 Matt 談談舒張壓，然後我再補充耐受性的部分。不過 Matt，你先開始吧？

So this will be our 12th pharmacokinetic trial on this product. So like the other studies, we're going to use the same vendor that we had excellent experience with. We're going to use the same laboratory that we had excellent experience with. We're going to, as the FDA requested, have all patients have healthcare administered Anaphylm. Like the FDA requested, we're going to have all patients also have an injection of IM manual epinephrine.

因此，這將是我們針對此產品的第 12 項藥物動力學試驗。因此，和其他研究一樣，我們將使用同一家我們有極佳合作經驗的供應商。我們也將使用同一家我們有極佳合作經驗的實驗室。依 FDA 要求，我們將讓所有病患都由醫療專業人員施用 Anaphylm。依 FDA 要求，我們也將讓所有病患另外接受一次 IM 手動注射腎上腺素。

And we have done this for our other pharmacokinetic trials. As the FDA requested, we're also going to have patients -- some patients received self-administered epinephrine Anaphylm that is going to follow the new updated instructions for use that are going to be tested and validated in the human factors trial.

而我們在其他藥物動力學試驗中也都這麼做過。依 FDA 要求，我們也會讓病患——其中部分病患——接受自行施用的腎上腺素 Anaphylm，並將遵循新版更新的使用說明（IFU）；該使用說明將在人體因子試驗中進行測試與驗證。

In addition, the FDA has requested top of tongue, and that was by far our largest observation in the last human factors trial. And of course, we'll be doing this. We'll have a discussion with the FDA on your other question on chewing. And we believe that this information can already be informed in the labeling by the fact that patients have already been tested and swallowed Anaphylm with 8 ounces of water. And we do -- and those patients did reach a therapeutic level of above 100 grams per millimeter.

此外，FDA 已要求進行「舌背（top of tongue）」的評估，而這在上一項人體因子試驗中是我們迄今為止最大的觀察發現。當然，我們會進行這項作業。至於您另一個關於咀嚼的問題，我們會與 FDA 討論。我們相信，這些資訊其實已可透過標示（labeling）加以說明，因為病患先前已在測試中以 8 盎司的水吞服 Anaphylm。而且我們確實——而那些病患也達到了高於每毫米 100 克的治療濃度水準。

So we'll have that discussion with the FDA. If the FDA believes that we have enough information to inform the label as we believe, then we'll proceed with the design that I just stated. If the FDA would like us to continue with the design that they stated, we also will do what they request. Either way, we're ready for this trial.

因此，我們會就此與 FDA 討論。若 FDA 認為我們已有足夠資訊可如我們所相信的那樣用於標示，我們就會依我剛才所述的設計推進。若 FDA 希望我們延續他們所提出的設計，我們也會照其要求執行。無論如何，我們已為這項試驗做好準備。

And Matt, if you could talk a little bit about how you think about diastolic blood pressure and whether it be our product or other products in space.

Matt，你能否談談你如何看待舒張壓，以及不論是我們的產品或同領域其他產品的情況？

Diastolic blood pressure is one of these interesting things clinically. You need your diastolic blood pressure to help maintain feeding blood to your coronary arteries during shock. So one of the things that's been observed now for a number of years with additional data with auto-injectors is that the injectable route, you see a slight dip for a couple of minutes where the diastolic blood pressure goes down and then comes up. Anaphylm operates a little bit differently than that, in that there is no initial dip. So what that may lead to is potential improvements in something called mean arterial pressure, which in like shock, it's a distributive shock.

舒張壓在臨床上是一個很有意思的議題。在休克期間，你需要舒張壓來幫助維持冠狀動脈的灌流供血。因此，過去幾年在自動注射器的更多數據中觀察到的一點是：採注射途徑時，舒張壓會在幾分鐘內出現輕微下滑，之後再回升。Anaphylm 的作用方式略有不同，因為它沒有一開始的下滑。因此，這可能帶來所謂平均動脈壓（mean arterial pressure）的潛在改善；在像休克這種情況下，它屬於分布性休克（distributive shock）。

You think about your plumbing system, there's runoff downstream and there's low pressure. You want to increase your mean arterial pressure. It will help perfuse your coronaries. It will keep the system running at a higher pressure. When you're resuscitating a patient, that's really what you're aiming for.

你可以把它想成管線系統：下游有外流，壓力偏低。你希望提高平均動脈壓。這將有助於冠狀動脈灌流。也能讓整個系統在較高壓力下運作。當你在復甦一位病患時，這正是你真正要達成的目標。

So these seem to be fairly ideal properties that one would want on paper for how you would resuscitate somebody. And it's exciting to be able to report those data. These are very interesting studies, and you learn a lot about sort of the epinephrine space with each of these studies that gets reported.

因此，從紙面上看，這些似乎是你在復甦病患時會希望具備的相當理想的特性。能夠報告這些數據令人振奮。這些研究非常有意思，而且每次有研究結果發表，你都能更深入了解腎上腺素這個領域的各種面向。

And Andreas, let me take the tolerability piece. So one of the things we didn't overly focus on in our original submission is what tolerability looks like across all of the products. So it's interesting when you step back and you look at the experience with the medical devices, there are multiple tolerability issues that occur, and we don't need to go into the specifics for each product on this call. But -- so in our resubmission, we'll definitely be making sure we characterize our product versus the alternatives that are available. And then as we stated in the supplemental material that you can see, if you go back to our study, there's very few cases.

Andreas，我來回答耐受性（tolerability）的部分。我們在最初的申報中，沒有過度聚焦於各產品整體的耐受性表現。但當你退一步看醫療器材的使用經驗時，會出現多種耐受性問題；我們不需要在這通電話中逐一討論各產品的細節。不過——因此，在我們的重新提交中，我們一定會確保對比現有替代方案，清楚刻畫我們產品的表現。此外，正如你在補充資料中所看到的，如果你回頭看我們的研究，案例非常少。

There's four individuals who had any ability to point to tolerability. One of the individuals who said, unprompted, while my life was at risk, I would leave the product in as long as I needed to. So I think on this issue, I would put it at much to do about nothing, and we'll make sure that we better characterize the current state in this space in our resubmission.

只有四位受試者出現任何可指向耐受性的情況。其中一位受試者在未被引導的情況下表示：當我的生命處於風險時，我會把產品留在口中，想留多久就留多久。因此，我認為在這個議題上，這是小題大作；我們會在重新提交中更好地刻畫此領域目前的現況。

Raghuram Selvaraju, H.C. Wainwright.

Raghuram Selvaraju，H.C. Wainwright。

Firstly, I was wondering if you could comment on any fundamental changes in your anticipated promotional campaign for support of Anaphylm as and when the product gets approved in the context of the revised sales force sizing. And if you see any recent moves by the folks promoting neffy that would guide promotional decisions that you're making in advance of the Anaphylm launch?

首先，我想請你們評論一下：在銷售團隊規模調整的背景下，若 Anaphylm 產品獲批並開始推廣，你們預期的推廣活動是否會有任何根本性的改變？另外，你們是否看到近期推廣 neffy 的團隊有任何動作，會在 Anaphylm 上市前指引你們正在做的推廣決策？

Sherry, do you want to take that?

Sherry，你要回答這題嗎？

Sure. Thanks so much for the question. As Dan mentioned earlier, our commercial infrastructure has mainly stayed intact. And so because of that, it is giving us time to go back and really refine our launch plan, aligned with having 75 reps and being well positioned if Anaphylm is approved by the FDA. I do think, though, that it continues, as you know, to be -- there is a significant unmet need in what continues to be a growing market.

好的。非常感謝這個問題。如 Dan 先前提到，我們的商業化基礎建設大致維持完整。因此，這也讓我們有時間回頭真正精煉上市計畫，使其與 75 位業務代表的配置一致，並在 Anaphylm 若獲 FDA 核准時處於良好位置。不過我確實認為，如你所知，這仍然——在一個持續成長的市場中，存在顯著未被滿足的需求。

And as Dan mentioned, with the competitive DTC, they continue to grow the market. And so that's a really positive thing. But there's still a need for an oral easy-to-carry, easy-to-use non-needle nondevice. We heard it over and over again this weekend at AAAAI.

而且如 Dan 所提到，競品的 DTC（直接面向消費者）推廣仍在持續擴大市場。因此這是一件非常正面的事。但市場仍需要一種口服、易攜帶、易使用、非針劑、非器材的選項。我們在這個週末的 AAAAI 會議上一次又一次聽到這點。

So what I would say, there are not fundamental changes in the work we're doing or the messaging, but we are taking the time, Ram, to really refine our positioning and refine all of the tactics that our reps will take to launch. As it relates to the competitors, look, we are always looking at the tactics, the promotional efforts, and it is informing us looking at their share of market and evaluating what is working and what is maybe not working as well. And so that is all going to inform our launch plan.

所以我想說的是，我們正在做的工作或訊息傳遞並沒有根本性的改變，但我們正在利用這段時間，Ram，真正精煉我們的定位，並精煉業務代表在上市時將採取的所有戰術。至於競爭對手，坦白說，我們一直在觀察他們的戰術與推廣作為；我們會參考他們的市占表現並評估哪些有效、哪些可能效果不如預期。而這些都將用來完善我們的上市計畫。

Very helpful. Secondly, I was wondering if you could just clarify how you're thinking about the timeline for future clinical development of AQST-108 relative to the timeline for the Anaphylm NDA resubmission and potential approval and launch timing for Anaphylm. Are you thinking about these two things completely independently? If they are connected in any way, can you give us a sense of how? And maybe just provide some granularity regarding the timing with which you expect to conduct the next stage of clinical development with AQST-108.

非常有幫助。第二，我想請你們釐清一下：你們如何看待 AQST-108 未來臨床開發的時間表，相對於 Anaphylm NDA 重新提交的時間表，以及 Anaphylm 可能的核准與上市時點？你們是把這兩件事完全獨立看待嗎？如果兩者有任何連結，你們能否讓我們了解是如何連結的？也請提供一些更細的資訊，說明你們預期何時會進行 AQST-108 下一階段的臨床開發。

Yes. No, thanks, Ram. And look, given the size and the focus of our organization, the only answer to this one is they absolutely are linked and Anaphylm is always going to win when there's a competition between Anaphylm and 108. I'm lucky to sit in this room with some great executives as you've heard this morning, but they're the same executives who are over 108. So we will prioritize Anaphylm, both from a resource perspective and a monetary perspective in the short term.

是的。不，謝謝你，Ram。你看，考量到我們組織的規模與聚焦方向，這題唯一的答案是：兩者絕對是連動的；而當 Anaphylm 與 108 之間出現資源競爭時，Anaphylm 永遠會優先。我很幸運能和一些優秀的高階主管同處一室，正如你今天早上所聽到的，但他們也是負責 108 的同一批主管。因此，短期內我們會優先推進 Anaphylm，無論在資源配置或資金投入上都是如此。

Having said that, we do have the ability to keep 108 moving, to keep learning, as Matthew talked about, around what we've got on our hands and how many different ways we can use it and to keep progressing it clinically once we get past the Anaphylm resubmission and we really hand over Anaphylm to the commercial side, I think that's when you'll see the workload on 108 pick up with our development team.

話雖如此，我們確實有能力讓 108 持續推進、持續學習——正如 Matthew 所談到的——針對我們手上所掌握的內容，以及我們可以用多少種不同方式來運用它；並且在完成 Anaphylm 重新遞交之後、真正把 Anaphylm 交接給商業端之後，持續在臨床上推進。我認為那時你會看到我們的開發團隊在 108 上的工作量開始增加。

Okay. Great. And then just two very quick ones. Can you indicate perhaps through the commercial evidence with regard to at least one or more of the diazepam-based formulations that are currently available on the market, if this provides any kind of market intel or foreshadowing as it were of what the future peak sales potential could be for Libervant in the United States? And then also, if you could just clarify for us whether the specific amount of the settlement with Neurelis was actually disclosed.

好的。很好。接著再兩個很快的問題。你能否就目前市面上至少一種或多種以地西泮（diazepam）為基礎的配方，透過其商業證據來說明：這是否能提供任何市場情報，或可說是對未來 Libervant 在美國的峰值銷售潛力有某種預示？另外，也請你澄清一下：與 Neurelis 的和解金額是否有實際對外揭露。

Yes. I'll start with the second one. Unfortunately, it tends to happen with these litigation settlements, it's confidential. So we can't disclose the settlement terms. Obviously, you can see our financial disclosures and make your own assessment.

是的。我先回答第二個。很不幸地，這類訴訟和解通常都是保密的。因此我們無法揭露和解條款。當然，你可以查看我們的財務揭露並自行評估。

What I would say is we put into our press release is what we were happy about and what led us to getting to the settlement is from a 2026 perspective, we believe it is cash neutral. So whether we had done the settlement or not, same plays on cash.

我想說的是，我們在新聞稿中所提到、我們感到滿意且促成和解的原因之一，是從 2026 年的角度來看，我們相信這在現金流上是中性的。也就是說，不論是否達成和解，對現金的影響是一樣的。

In terms of Libervant and looking at that opportunity and what peak sales could be for Libervant, this one is bittersweet, Ram. I would love to launch Libervant. And we have put our heart and soul into what we believe is a great product that will help patients in this space. But we can't launch Libervant and Anaphylm within a month of each other. It's just not humanly possible for the companies even much larger than us.

至於 Libervant，談到那個機會以及 Libervant 的峰值銷售可能是多少，這件事對我來說是苦樂參半，Ram。我很希望能推出 Libervant。我們也把全部心力投入在我們相信是一個很棒、能幫助這個領域患者的產品上。但我們不可能在相隔一個月內同時推出 Libervant 和 Anaphylm。即使是比我們大得多的公司，從人力上也做不到。

So we've made the decision that Anaphylm is the priority. We do have some great potential partnerships, licensing opportunities that our team is looking at. And I do think that if you look at how Valtoco and Nayzilam have penetrated in that market, there's still a great opportunity, especially where portability, convenience, speed of use are important for this product to become an important component in that space.

因此我們決定把 Anaphylm 作為優先事項。我們確實有一些很好的潛在合作夥伴與授權機會，團隊正在評估。而且我確實認為，如果你看看 Valtoco 和 Nayzilam 在該市場的滲透情況，仍然有很大的機會——特別是在可攜性、便利性、使用速度對這個產品很重要的情境下——讓它成為該領域的重要組成。

Thomas Flaten, Lake Street Capital Markets.

Thomas Flaten，Lake Street Capital Markets。

Are there any current analogs that give you some faith in a potential accelerated approval? I know FDA in its current incarnation can be a little bit confusing.

目前是否有任何可類比的案例，能讓你對可能獲得加速核准更有信心？我知道 FDA 以目前的運作方式，有時會讓人有點摸不著頭緒。

Sure. That's an easy one, our competitor. Our competitor got a CRL and resubmitted with a 6-month clock and got their approval in four months. So we'll do it nicely, but we will definitely be reminding this review division that they did that and that our expectation is we're handing in a very thin package to meet their requests, and it shouldn't take six months to review. Now whether they act faster or not, Thomas, to your underlying point is completely up to them.

當然。這個很簡單：我們的競爭對手。我們的競爭對手收到 CRL 後重新遞交，原本是 6 個月的審查時程，但他們在 4 個月就獲得核准。所以我們會以適當方式處理，但我們一定會提醒這個審查部門：他們曾經那樣做過；而我們的預期是，我們提交的是一份非常精簡、用來滿足他們要求的資料包，審查不應該需要 6 個月。至於他們是否會更快行動，Thomas，你所指的核心點完全取決於他們。

Got it. And then is it safe for us to assume that any submissions outside the US will be after the full package has been resubmitted to FDA, just timing-wise?

了解。那麼，就時程而言，我們是否可以安全地假設：任何美國以外的遞交，都會在向 FDA 重新遞交完整資料包之後才進行？

Yes. We're guiding that Europe and Canada will be in 2026, but they will come after US Canada, literally, we could put in whenever we get it done, but it's just got to come after the US. So some of this is just making sure we prioritize the US over everything else.

是的。我們的指引是歐洲與加拿大會在 2026 年，但它們會在美國之後；實際上，只要我們完成，隨時都可以遞交，但必須排在美國之後。所以其中一部分就是確保我們把美國的優先順序放在其他一切之前。

Got it. And then I guess, regardless of approval time, could you clarify a little bit because I know there's a few things going on, including hiring of the reps, some of the product-related work you have to do. So from approval to full commercial launch, can you give us a sense of what that timing will look like?

了解。那我想，不論核准時間如何，你能否再澄清一下：因為我知道目前有幾件事同時在進行，包括招募業務代表，以及你們必須完成的一些產品相關工作。所以從核准到全面商業上市，你能否讓我們大致了解那個時程會是什麼樣子？

Yes, approval to -- if by full commercial launch, you mean reps in the field and product in distribution. I think it's the same time line we guided to this last go around, which was, if you think about it, around an eight-week window. So the -- what it precisely is under eight weeks is all dependent on how much we lean forward ahead of approval. So call it, zero to eight weeks.

可以，從核准到——如果你所說的全面商業上市，是指業務代表到位、產品進入通路。我認為時程與我們上一次所給的指引相同；如果你想一想，大約是 8 週的窗口期。所以——在 8 週之內究竟會是多久，完全取決於我們在核准前願意提前推進多少。因此可以說是 0 到 8 週。

And I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Dan Barber for any closing remarks.

我目前看到隊列中沒有其他問題。我現在把電話交回給 Dan Barber 先生，請他做結語。

Thank you, Olivia, and thank you, everyone, for joining us today. As you heard, we are on track in every way right now. The epinephrine market continues to grow, and we're excited for patients to have access to Anaphylm as soon as it is approved by the FDA. We look forward to keeping you updated on our progress in the weeks and months to come. And with that, Olivia, let's end the call.

謝謝你，Olivia，也謝謝各位今天加入我們。如各位所聽到的，我們目前在各方面都按計畫推進。腎上腺素市場持續成長，我們也很期待患者能在 FDA 核准後，盡快取得 Anaphylm。我們期待在接下來幾週與幾個月持續向各位更新我們的進展。那麼，Olivia，我們就結束這通電話。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位的參與，現在可以掛線。