Aquestive Therapeutics Inc (AQST) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Aquestive Therapeutics first quarter 2025 earnings conference call. (Operator Instructions) Please be advised today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Aquestive Therapeutics 2025 年第一季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to turn the conference over to your host today, Brian Korb. Please go ahead.

現在我想將會議交給今天的主持人 Brian Korb。請繼續。

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. We're going to provide an overview of recent business developments and performance for the first quarter of 2025 followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Carl Kraus, Chief Medical Officer; and Sherry Korczynski, Senior Vice President, Sales and Marketing.

謝謝您，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，執行長 Dan Barber 也與我一起出席；以及財務長 Ernie Toth。我們將概述 2025 年第一季的最新業務發展和業績，然後進行問答環節。在問答環節，首席醫療官 Carl Kraus 博士將加入團隊；以及銷售和行銷資深副總裁 Sherry Korczynski。

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 will be made available on Aquestive's website within the Investors section shortly following the conclusion of this call.

提醒一下，該公司今天的言論與昨天收盤後發布的收益報告相符。此外，今天的電話會議錄音將在電話會議結束後不久在 Aquestive 網站的投資者部分提供。

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

提醒您，Aquestive 團隊將於今天上午討論一些非 GAAP 財務指標，作為 2025 年第一季度業績審查的一部分。這些措施的描述以及與 GAAP 的對帳可以在昨天發布的收益報告中找到，該報告發佈在 Aquestive 網站的投資者部分。

During the call, the company will make 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2025.

在電話會議期間，公司將做出前瞻性陳述。我們提醒您注意公司在昨天的收益報告中概述的安全港語言，以及影響公司的風險和不確定性，如公司在 2025 年 5 月 12 日向美國證券交易委員會提交的 10-Q 表季度報告中的風險因素部分和其他部分所述。

As any pharmaceutic 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.

與任何製藥公司一樣，由於產品候選物正在開發中且產品正在商業化，因此公司的業務以及產品的開發、監管批准和商業化以及與營運相關的其他事項存在重大風險和不確定性。鑑於這些不確定性，您不應過度依賴這些前瞻性陳述，這些陳述僅代表截至作出之日的觀點。

Actual results may differ materially from these statements. All forward-looking statements attributable to Aquestive or any person acting on 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.

實際結果可能與這些陳述有重大差異。所有歸因於 Aquestive 或代表其行事的任何人士的前瞻性陳述均完全符合本警告聲明以及昨天發布的收益報告中包含的警告聲明。除非適用法律要求，否則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.

現在我想把電話轉給丹。

Thanks, Brian, and good morning, everyone. We are now over a month into our FDA review for Anaphylm epinephrine sublingual film, which if approved by the FDA, will be the first and only oral medication indicated for the treatment of severe allergic reactions, including anaphylaxis.

謝謝，布萊恩，大家早安。目前，我們對 Anaphylm 腎上腺素舌下膜進行 FDA 審查已有一個多月了，如果獲得 FDA 批准，它將成為第一個也是唯一一個用於治療嚴重過敏反應（包括過敏反應）的口服藥物。

As a reminder, we believe that in the years to come, the rescue medication market for severe allergic reactions will grow into a multibillion-dollar opportunity. We anticipate receiving our FDA acceptance letter next month with an FDA assigned action date in late January or early February of 2026.

提醒一下，我們相信在未來幾年，嚴重過敏反應的救援藥物市場將發展成為一個價值數十億美元的商機。我們預計下個月收到 FDA 的接受函，FDA 指定的行動日期為 2026 年 1 月底或 2 月初。

This is truly the most exciting time in the history of Aquestive and we have officially entered the commercial prelaunch phase for Anaphylm. As the review clock ticks toward approval, we are shifting more and more of the company's attention towards ensuring a successful commercial launch in the first quarter of 2026, if approved by the FDA.

這確實是 Aquestive 歷史上最令人興奮的時刻，我們已經正式進入 Anaphylm 的商業預發布階段。隨著審查時間臨近批准，我們將公司越來越多的注意力轉向確保在獲得 FDA 批准後於 2026 年第一季成功進行商業發布。

The first area of focus is ensuring we have the right people who have both significant experience in the allergy space and the right commercial experience to launch Anaphylm. I'm pleased to say that we have the marketing team that built EpiPen to over a $1 billion brand, and we have added colleagues with decades of market access and commercial launch experience.

第一個重點領域是確保我們擁有合適的人才，這些人才不僅在過敏領域擁有豐富的經驗，還具備推出 Anaphylm 的正確商業經驗。我很高興地說，我們擁有將 EpiPen 打造為價值超過 10 億美元的品牌的行銷團隊，我們也吸收了具有數十年市場准入和商業發布經驗的同事。

I am thrilled by the team we have put in place. Our second area of focus is awareness of anaphylaxis and our clinical data among health care professionals.

我對我們組建的團隊感到非常興奮。我們的第二個關注領域是醫療保健專業人員對過敏反應和臨床數據的認知。

As we are in the prelaunch phase, this work is conducted by our medical team through outreach to health care providers. We are very active in attending allergy conferences both national and local, where we present our posters and our publications.

由於我們處於啟動前階段，這項工作是由我們的醫療團隊透過聯繫醫療保健提供者來進行的。我們非常積極地參加國家和地方的過敏會議，並在會議上展示我們的海報和出版物。

I'm proud to share that by the end of this year, we expect to have attended 25 conferences and published 16 posters and manuscripts. By our anticipated FDA action date, we will have published almost 30 posters and manuscripts over the life of the Anaphylm development program.

我很自豪地告訴大家，到今年年底，我們預計將參加 25 次會議並發表 16 張海報和手稿。在我們預計的 FDA 行動日期時，我們將在 Anaphylm 開發計劃的整個生命週期內發布近 30 份海報和手稿。

As a comparison, the sponsor of the recently approved nasal spray published approximately 20 posters and manuscripts before their approval. It is work like this that has me confident that we are well positioned to continue to increase our prelaunch awareness.

作為比較，最近批准的鼻噴劑的申辦者在批准之前發表了大約 20 張海報和手稿。正是這樣的工作讓我相信，我們有能力繼續提高我們的發布前意識。

The third area of focus is payer engagement. As I mentioned in March, we now have in-house market access expertise, and we are actively working with payers, given the FDA rules that allow us to engage with payers in advance of anticipated approval.

第三個重點領域是付款人參與。正如我在三月提到的，我們現在擁有內部市場准入專業知識，我們正在積極與付款人合作，因為 FDA 規則允許我們在預期批准之前與付款人接觸。

We will benefit from the distribution and payer contracts that were set up during our marketing of Libervant. These contracts remain in place, and we will be able to utilize them for Anaphylm.

我們將受益於在 Libervant 行銷期間建立的分銷和付款人合約。這些合約仍然有效，我們將能夠將它們用於 Anaphylm。

Critically, these will save months and months of startup time and add to our launch efficiency. Our positioning and advertising materials are well ahead of schedule for a launch in early of 2026.

至關重要的是，這些將節省數月的啟動時間並提高我們的啟動效率。我們的定位和廣告材料已提前完成，預計將於 2026 年初推出。

We have been clear about our positioning for quite some time. Among patients and caregivers, we will focus on the ability to easily carry Anaphylm.

我們對我們的定位已經很明確了。在患者和照護者中，我們將專注於輕鬆攜帶 Anaphylm 的能力。

We believe Anaphylm is the only product that if approved by the FDA, and allows for not just one but two doses to easily fit on the back of your phone, into a wallet or a small purse, providing patients with an epinephrine product that can be with them any time anywhere. This clearly resonates across the stakeholder spectrum, and I am genuinely excited about the progress our marketing team has made.

我們相信 Anaphylm 是唯一獲得 FDA 批准的產品，並且允許將不止一劑而是兩劑輕鬆放在手機背面、錢包或小手提包中，為患者提供可以隨時隨地隨身攜帶的腎上腺素產品。這顯然引起了各利害關係人的共鳴，我對我們的行銷團隊所取得的進步感到非常興奮。

We remain very active on the advocacy front as well. We have significant engagement with all four of the national allergy advocacy groups. We continue to sponsor several important patient programs with these groups and more recently, have become involved in shaping state-level legislative actions geared towards ensuring patients have access to all premeasured forms of epinephrine.

我們在宣傳方面也仍然非常活躍。我們與所有四個國家過敏倡導組織都有密切的合作。我們繼續與這些團體一起贊助幾個重要的患者項目，最近，我們開始參與制定州級立法行動，以確保患者能夠獲得所有預先測量形式的腎上腺素。

So from a commercial preparedness perspective, we have built a team of the right people, developed a robust prelaunch awareness platform, utilized our existing payer relationships to prepare for Anaphylm, build our product messaging and advertising and established significant relationships with the key advocacy groups. This, to me, positions us incredibly well for a fast start in 2026.

因此，從商業準備的角度來看，我們組建了一支合適的團隊，開發了一個強大的上市前宣傳平台，利用我們現有的付款人關係為 Anaphylm 做準備，建立我們的產品信息和廣告，並與主要倡導團體建立了重要的關係。對我來說，這為我們在 2026 年的快速起步做好了極為有利的準備。

Now let's dig a little deeper into exactly how patients will experience Anaphylm. Think about your phone for a minute. Think about the incredible power that you hold in your hand every single day. From your phone, you can check the security at your house, start your car, track your heart rate, search the web for any piece of information on the planet.

現在讓我們更深入了解患者究竟會如何體驗 Anaphylm。想一想你的手機。想想每天你手中握有的不可思議的力量。透過手機，您可以檢查家中的安全狀況、啟動汽車、追蹤心率、在網路上搜尋地球上的任何資訊。

And now thanks to Anaphylm and our farm film technology, it can act as your medicine cabinet. Now that's transformational. In fact, the mom of the teenage patient recently told us, and I quote, my kid never takes his current device with him.

現在，由於 Anaphylm 和我們的農場薄膜技術，它可以充當您的藥櫃。現在，這已經發生了轉變。事實上，這位青少年患者的媽媽最近告訴我們，我引用她的話說，我的孩子從來不隨身攜帶他現在的設備。

So while there are times they have no idea where he is, what he's doing, what he might be eating, I do know I see his epinephrine device getting at home on his bedroom dresser, which puts me into complete stress mode. The other thing I know is that without fail, he has his phone with him.

因此，雖然有時他們不知道他在哪裡，在做什麼，在吃什麼，但我確實看到他的腎上腺素裝置放在他臥室的梳妝台上，這讓我感到非常緊張。我還知道另一件事，那就是他肯定隨身帶著手機。

How comforted I would be knowing that two doses of epinephrine were tucked into the back of his phone. In other words, he would never leave home without it. It is realizations like this one that we believe drive caregivers and patients to show a two to one preference for Anaphylm over the existing medical devices.

當我得知他的手機背面裝有兩劑腎上腺素時，我感到多麼安慰。換句話說，沒有它他絕對不會離開家。我們相信，正是這樣的認識促使護理人員和病人對 Anaphylm 的偏好度達到現有醫療設備的兩倍。

And that is also why with Anaphylm (inaudible) truly is believing. When we have the opportunity to show our technology physically, we find excitement and growing interest in prescribing opportunities. In fact, almost 100% of health care providers we have surveyed and we've done a lot of surveys, believe their patients will be interested in Anaphylm.

這也是為什麼 Anaphylm (聽不清楚) 確實相信。當我們有機會實際展示我們的技術時，我們發現人們對處方機會越來越感興趣。事實上，我們調查過的醫療保健提供者幾乎 100% 都相信他們的患者會對 Anaphylm 感興趣，我們也做過大量調查。

We also know that direct-to-consumer, or DTC, engagement is a significant element to awareness in this disease state. DTC efforts cost money and we will need to strengthen our balance sheet ahead of launch to use this part of our strategy effectively.

我們也知道，直接面向消費者（DTC）的參與是提高人們對這種疾病狀態的認識的重要因素。DTC 工作需要花錢，我們需要在推出之前加強我們的資產負債表，以便有效地利用我們策略的這一部分。

While Ernie will give you more specifics on our financials, I'd like to share how I think about our cash position. First, we announced last night that we will deemphasize our AQST-108 studies during this launch period.

雖然厄尼會向您提供有關我們財務狀況的更多細節，但我想分享我對我們的現金狀況的看法。首先，我們昨晚宣布，我們將在此啟動期間不再強調 AQST-108 研究。

While we are as committed as ever to 108, this frees up significant capital for commercial activities. Similarly, while we were unhappy with the court outcome on Libervant, and we think this ultimately harms patients, this also allowed us to shift cash from supporting Libervant to the launch of Anaphylm.

雖然我們一如既往地致力於 108，但這為商業活動釋放了大量資金。同樣，雖然我們對 Libervant 的法庭判決感到不滿，並且我們認為這最終會損害患者的利益，但這也使我們能夠將資金從支持 Libervant 轉移到 Anaphylm 的推出。

We will opportunistically look to strengthen our balance sheet through ex US out-licensing Anaphylm and potential refinancing our debt. These pathways could provide adequate runway for the support of Anaphylm, not just through launch but through the first year of launch and into 2027.

我們將抓住機會，透過美國以外的 Anaphylm 授權和潛在的債務再融資來加強我們的資產負債表。這些途徑可以為 Anaphylm 的支援提供足夠的跑道，不僅透過發射，而且透過發射的第一年到 2027 年。

We also continue to engage with potential sales and marketing partners in the US. However, as I've said before, the conditions have to be just right for this to be our path forward. Now let me turn to the FDA review of Anaphylm.

我們也繼續與美國的潛在銷售和行銷合作夥伴合作。然而，正如我之前所說，我們必須具備適當的條件才能走這條前進的道路。現在讓我來談談 FDA 對 Anaphylm 的審查。

We are pleased to say that we have already had engagement with the review division regarding our application. As of today, we believe everything is on schedule for a receipt of our 74 day acceptance letter in mid-June.

我們很高興地說，我們已經就我們的申請與審查部門進行了接觸。截至今天，我們相信一切都按計劃進行，我們將在 6 月中旬收到 74 天的錄取通知。

We also believe our reviewers remain employed at the FDA, though we do know that Sally Seymour, the Division Head for Pulmonary Allergy and Critical Care, recently announced her retirement. We do not believe this has an impact on our application.

我們也相信我們的審查員仍然受僱於 FDA，儘管我們確實知道肺部過敏和重症監護部門負責人 Sally Seymour 最近宣布退休。我們不認為這會對我們的申請產生影響。

We continue to prepare for an advisory committee meeting should the FDA require one. This work remains on schedule, and we continue to believe we will be fully prepared for an Ad Comm well ahead of schedule should it occur.

如果 FDA 需要，我們將繼續為諮詢委員會會議做準備。這項工作仍在按計劃進行，我們仍然相信，如果 Ad Comm 召開，我們將提前做好充分準備。

Our regulatory team is also turning into focus to international markets. As I've mentioned before, we expect to engage with Canada, the United Kingdom and the European Medicines Agency, or EMA, prior to approval of Anaphylm in the US. These activities are in support of strengthening our balance sheet through finding a strategic ex US partner.

我們的監管團隊也開始將注意力轉向國際市場。正如我之前提到的，我們希望在美國批准 Anaphylm 之前與加拿大、英國和歐洲藥品管理局 (EMA) 接觸。這些活動有助於透過尋找前美國戰略合作夥伴來加強我們的資產負債表。

Now let's turn to the macro environment for public life sciences companies. For most companies, the last few months have been very difficult. The long-term prospect of tariffs and economic uncertainty has created volatility in many ways, including revenue streams, supply chain and long-term outlook.

現在讓我們來看看上市生命科學公司的宏觀環境。對大多數公司來說，過去幾個月非常艱難。關稅和經濟不確定性的長期前景在許多方面造成了波動，包括收入來源、供應鏈和長期前景。

In this environment, I am pleased to say we are well positioned. We have examined our supply chain and see minimal risk to price or supply volatility. Importantly, we also house our intellectual property here in the US.

在這種環境下，我很高興地說我們處於有利地位。我們已經檢查了我們的供應鏈，發現價格或供應波動的風險很小。重要的是，我們也將我們的智慧財產權保存在美國。

Simply put, we believe we are well positioned to weather the economic storm that has been impacting small businesses and the life sciences industry. Finally, I want to acknowledge and honor the previously announced recent passing of Dr. Stephen Wargacki, our Chief Science Officer.

簡而言之，我們相信我們已做好準備，抵禦這場影響小型企業和生命科學產業的經濟風暴。最後，我要承認並紀念我們首席科學官 Stephen Wargacki 博士最近去世的消息。

Steve and I worked together for over a decade, and he was not only a brilliant scientist and a colleague but also a friend. He was a major contributor to the scientific advancement of Anaphylm and we will honor his memory as we seek approval of Anaphylm around the world.

史蒂夫和我一起工作了十多年，他不僅是一位傑出的科學家和同事，也是一位朋友。他是 Anaphylm 科學進步的主要貢獻者，我們將在尋求 Anaphylm 在世界範圍內獲得認可的同時，緬懷他。

While we are fortunate to have his mentor, the former Chief Technology Officer and Founding CEO, Mark Schobel, take over interim oversight of R&D, Steve will be profoundly missed by all of us. So as we move forward, our focus over the coming months will be engagement with the FDA on the review of our application, engagement with ex US regulatory bodies on Anaphylm, strengthening our balance sheet through partnerships and potentially debt refinancing, maintaining our strong position in relation to tariffs and economic uncertainty and more than anything else, having laser-like focus on our commercial launch of Anaphylm.

雖然我們很幸運能有他的導師、前技術長兼創始執行長 Mark Schobel 臨時接手研發工作，但我們所有人都會深深懷念史蒂夫。因此，隨著我們不斷前進，未來幾個月我們的重點將是與 FDA 合作審查我們的申請，與前美國監管機構就 Anaphylm 進行合作，透過合作夥伴關係和潛在的債務再融資加強我們的資產負債表，保持我們在關稅和經濟不確定性方面的強勢地位，最重要的是，全神貫注於 Anaphylm 的商業發布。

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

說完這些，我會把電話轉給厄尼。

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 first quarter results in the Q&A.

謝謝你，丹，大家早安。到目前為止，您將已經在昨晚發布的收益報告中看到了我們的財務表現。像往常一樣，我們將在問答環節討論與第一季業績相關的大部分內容。

During the first quarter, we continued to execute on our strategy to support the continued development of the recently filed NDA for Anaphylm, our lead product candidate that has no needle, it's not a device, it's orally administered and is easy to carry. This included strengthening our balance sheet with additional capital through our ATM facility and pre-commercial launch activities for Anaphylm to increase awareness among physicians, payers and the advocacy community.

在第一季度，我們繼續執行我們的策略，以支持最近提交的 Anaphylm NDA 的持續開發，Anaphylm 是我們的主要候選產品，它沒有針頭，不是設備，而是口服的，而且易於攜帶。這包括透過我們的 ATM 設施為 Anaphylm 注入額外資本來加強我們的資產負債表，以及進行 Anaphylm 的商業化前發布活動，以提高對醫生、付款人和倡導社區的意識。

Aquestive's manufacturing business remained steady with a gradual decline of Suboxone being partially offset by growth across newer collaborations, including for the licensed products, Ondif, Sympazan and Emylif. Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations.

Aquestive 的製造業務保持穩定，Suboxone 的逐漸下滑被包括許可產品 Ondif、Sympazan 和 Emylif 在內的新合作的增長部分抵消。Aquestive 的製造工廠繼續實現業務多元化，以支持更廣泛的產品和合作。

In addition, being a US-based manufacturer with intellectual property domiciled in the US, our supply chain currently remains largely unaffected by both implemented and proposed tariffs providing continued reliability and stability in production and global distribution for the near term.

此外，作為一家總部位於美國且知識產權位於美國的製造商，我們的供應鏈目前基本上不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持續的可靠性和穩定性。

Now let's turn to the first quarter results. Total revenues decreased to $8.7 million in the first quarter of 2025 from $12.1 million in the first quarter of 2024.

現在讓我們來看看第一季的業績。總收入從 2024 年第一季的 1,210 萬美元下降至 2025 年第一季的 870 萬美元。

This 28% decrease in revenue was primarily driven by decreases in manufacture and supply revenue and license and royalty revenue, partially offset by increases in proprietary product revenue net. Manufacturer and supply revenue decreased to $7.2 million in the first quarter of 2025 from $10.5 million in the first quarter of 2024 primarily due to decreases in Suboxone revenues, partially offset by an increase in Ondif revenues.

收入下降 28% 主要是由於製造和供應收入以及許可和特許權使用費收入的下降，但專有產品淨收入的增加部分抵消了這一下降。製造商和供應收入從 2024 年第一季的 1,050 萬美元減少至 2025 年第一季的 720 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影響。

License and royalty revenue decreased 30% or $0.3 million in the first quarter of 2025 compared to the same period in the prior year. This decrease was primarily due to lower Azstarys royalty revenues and lower license revenues associated with the termination of a licensing and supply agreement in the prior year.

2025 年第一季度，授權和特許權使用費收入與去年同期相比下降了 30%，即 30 萬美元。下降的主要原因是 Azstarys 特許權使用費收入下降，以及上一年終止授權和供應協議導致的授權收入下降。

Codevelopment and research fees in the first quarter of 2025 remained relatively unchanged compared to the same period in the prior year. Research and development expenses decreased to $5.4 million in the first quarter of 2025 from $5.9 million in the first quarter of 2024.

2025 年第一季的共同開發和研究費用與去年同期相比基本保持不變。研發費用從 2024 年第一季的 590 萬美元減少至 2025 年第一季的 540 萬美元。

The decrease in research and development 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 and preclinical expenses, higher personnel costs and higher share-based compensation.

研發費用的減少主要是由於 Anaphylm 開發計劃的持續推進導致臨床試驗成本降低，但產品研究和臨床前費用的增加、人員成本的增加以及股權激勵的增加部分抵消了這一減少。

Selling, general and administrative expenses increased to $19.1 million in the first quarter of 2025 from $10.7 million in the first quarter 2024 primarily due to regulatory fees of $4.8 million, including the Anaphylm PDUFA fee, higher legal fees of $2.3 million, higher commercial spending of approximately $2.1 million, higher personnel costs of approximately $0.4 million and higher share-based compensation expense of $0.3 million, partially offset by decreases in severance costs of approximately $1.1 million and lower insurance expenses of $0.2 million.

銷售、一般和行政費用從 2024 年第一季的 1,070 萬美元增至 2025 年第一季的 1,910 萬美元，主要原因是監管費用為 480 萬美元，包括 Anaphylm PDUFA 費用、法律費用增加 230 萬美元、商業支出增加約 210 萬美元、人員成本以及約 10 萬美元激勵約 10 萬美元增加股權萬美元和保險費用減少 20 萬美元部分抵銷。

Aquestive's net loss for the first quarter of 2025 was $22.9 million or $0.24 for both basic and diluted loss per share compared to the net loss for the first quarter of 2024 of $12.8 million or $0.17 for both basic and diluted loss per share. The increase in net loss was primarily driven by the previously discussed changes, partially offset by increases in interest income and other income.

Aquestive 2025 年第一季的淨虧損為 2,290 萬美元，即每股基本虧損和稀釋虧損均為 0.24 美元，而 2024 年第一季的淨虧損為 1,280 萬美元，即每股基本虧損和稀釋虧損均為 0.17 美元。淨虧損的增加主要是由於先前討論過的變化所致，但部分被利息收入和其他收入的增加所抵消。

Non-GAAP adjusted EBITDA loss was $17.6 million in the first quarter of 2025 compared to non-GAAP adjusted EBITDA loss of $7.2 million in the first quarter of 2024. Cash and cash equivalents were $68.7 million as of March 31, 2025.

2025 年第一季非 GAAP 調整後 EBITDA 虧損為 1,760 萬美元，而 2024 年第一季非 GAAP 調整後 EBITDA 虧損為 720 萬美元。截至 2025 年 3 月 31 日，現金及現金等價物為 6,870 萬美元。

Aquestive has revised its full year 2025 financial guidance as a result of the change in regulatory status of Libervant and pausing sales and marketing activities for the product. The company now expects total revenue of $44 million to $50 million and non-GAAP adjusted EBITDA loss of $47 million to $51 million.

由於 Libervant 監管狀態的變化以及暫停該產品的銷售和行銷活動，Aquestive 修改了其 2025 年全年財務指導。該公司目前預計總收入為 4,400 萬至 5,000 萬美元，非 GAAP 調整後 EBITDA 虧損為 4,700 萬至 5,100 萬美元。

Our revenue guidance for 2025 no longer includes revenue for Libervant for ages between two and five years. As a reminder, our 2024 revenue included onetime nonrecurring recognition of deferred revenue related to the termination of certain licensing and supply agreements.

我們對 2025 年的收入預測不再包括 2 至 5 年 Libervant 的收入。提醒一下，我們的 2024 年收入包括與終止某些授權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 includes significant pre-commercial spending for Anaphylm, costs associated with the recent submission of the Anaphylm NDA and related filing fee, completion of the Anaphylm pediatric clinical trial and preparations for a potential advisory committee meeting if required by the FDA for approval of Anaphylm.

我們對 2025 年非 GAAP 調整後 EBITDA 虧損的預測包括 Anaphylm 的大量商業化前支出、最近提交 Anaphylm NDA 的相關成本和相關申請費、完成 Anaphylm 兒科臨床試驗以及為 FDA 批准 Anaphylm 所需的潛在諮詢委員會會議做準備。

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

說完這些，我現在將電話轉回給接線生，以便大家可以提問。

(Operator Instructions)

（操作員指示）

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

Hey, good morning everyone. So a couple for me. I was curious if you could update us on where you are in your commercial readiness efforts, including CMC, manufacturing scale-up, et cetera, for Anaphylm? And I was also wanted to see if you find your goals for hiring a field force for Anaphylm, including how many physicians would they target out of the gate?

嘿，大家早安。對我來說這是一對。我很好奇，您能否向我們介紹一下 Anaphylm 的商業準備工作進度，包括 CMC、生產規模擴大等？我還想看看您是否找到了為 Anaphylm 招募現場人員的目標，包括他們一開始會瞄準多少名醫生？

Roanna, so I'll take this is Dan. I'll take the first part of your question, then I'll hand it over to Sherry to talk about the sales force and how she thinks about it. One of the highlights of things that we're proud of and think of the strength for our company is the fact we have the manufacturing in-house.

Roanna，我認為這是 Dan。我將回答您問題的第一部分，然後交給雪莉來談談銷售隊伍以及她對此的看法。我們引以為傲、並認為是我們公司優勢的亮點之一就是我們擁有內部製造能力。

So as you know, CMC manufacturing scale up, that is all well within our capabilities and something we've done several times before without issue. So we believe we're very well prepared on that side.

因此，如您所知，CMC 製造規模的擴大完全在我們的能力範圍內，而且我們之前已經多次做過，沒有任何問題。因此我們相信我們在這方面已經做好了充分的準備。

We'll have products ready to go day one. And those plans are in place and being worked on. So I'll pass it over to Sherry to talk about the sales force.

我們將在第一天就準備好產品。這些計劃已經制定並正在實施中。因此我將把話題交給雪莉來談論銷售隊伍。

Hi Roanna, I have to say I'm so excited to be chatting with everybody this morning as we are very focused on a successful launch. As you know, I built the team that built EpiPen to over $1 billion.

嗨，Roanna，我必須說我很高興今天早上能和大家聊天，因為我們非常專注於成功發布。如你所知，我組建的團隊將 EpiPen 的市值推高至 10 億美元以上。

And as I reflect upon that build, one of the things that I have been looking very closely at is the number of salespeople. And so we will probably start at around 50 sales representatives and focus on the top of Anaphylm prescribers, as I'm sure you can imagine, that will include about 4,000 or 5,000 of the top allergists and pediatricians as well as the NPPA staff that really support the physicians and the allergists in the office.

當我反思這項建設時，我一直密切關注的事情之一就是銷售人員的數量。因此，我們可能會從大約 50 名銷售代表開始，並專注於 Anaphylm 處方的頂級醫生，我相信您可以想像，這將包括大約 4,000 或 5,000 名頂級過敏症專科醫生和兒科醫生以及真正支持辦公室醫生和過敏症專科醫生的 NPPA 員工。

And so that's where we are right now. We're in the process of conducting segmentation and ensuring our marketing mix model works very smart for us.

這就是我們現在的處境。我們正在進行細分，並確保我們的行銷組合模型能夠為我們帶來良好的效果。

Yeah. Very helpful. And one follow-up for me. I was thinking ahead to the Anaphylm launch, could you explain a bit more about your key goals in interacting with payers to set up broader favorable access for Anaphylm? And do you have any idea of the time lines it would take to set up this access in the best case of favorable coverage for Anaphylm for a majority of patients?

是的。非常有幫助。對我來說還有一個後續行動。我正在考慮 Anaphylm 的推出，您能否進一步解釋您與付款人互動的主要目標，以便為 Anaphylm 建立更廣泛的有利管道？您是否知道在 Anaphylm 能夠為大多數患者提供良好覆蓋的最佳情況下，建立這種途徑需要多長時間？

Right. Well, I'll let Sherry give you her thoughts in a second here, but I just want to reiterate, as you just heard in my comments before, with the work we did on Libervant, one of the great benefits is the contracts that we now have in place, both from a distribution and a payer perspective.

正確的。好吧，我讓雪莉馬上告訴你她的想法，但我只想重申一下，正如你之前在我的評論中聽到的那樣，我們在 Libervant 上所做的工作，最大的好處之一就是我們現在已經簽訂了合同，無論是從分銷還是付款人的角度來看。

So those remain open, and we will definitely be able to leverage those as we go into this launch period. But Sherry, you can talk more about her specific thoughts on our goals.

因此，這些仍然是開放的，當我們進入這個啟動期時，我們肯定能夠利用它們。但是雪莉，你可以多談談她對我們的目標的具體想法。

Sure. As Dan mentioned, we have hired VP of Market Access, and we took our time to make sure we hire the right person. And so we brought on someone who has experience in small pharma and very large pharma, who knows the payers personally and has extensive experience in launching products.

當然。正如丹所提到的，我們已經聘請了市場准入副總裁，並且我們花了時間來確保我們聘請了合適的人才。因此，我們聘請了一位在小型製藥公司和大型製藥公司都有經驗的人，他了解付款人，並且在推出產品方面擁有豐富的經驗。

And so we're very excited about her and the team that she is bringing on. As Dan mentioned, we have been working with the payers, both on Libervant and messaging around Anaphylm, given the guidance that permits us to do that.

因此，我們對她和她帶領的團隊感到非常興奮。正如丹所提到的，在得到允許我們這樣做的指導後，我們一直在與付款人合作，包括 Libervant 和 Anaphylm 相關的資訊傳遞。

And so when we think about the access, as you know, we will be entering a period now of furthering those conversations and upon approval, have be ready to do our, have our contracting strategy implemented. Now if you take a look and you can just use our competitor as an example, there is timing associated.

因此，當我們考慮存取權限時，如您所知，我們現在將進入進一步推進這些對話的時期，並在獲得批准後，準備好實施我們的承包策略。現在，如果你看一看，你可以用我們的競爭對手作為例子，其中有相關的時間。

The payers do require a rather significant amount of time, several months before they will consider adding to formulary. So I would think about it as kind of the first six months of launch, we will be ensuring that we have upwards of 80% coverage by the end of that six months, which, Roanna, we would take us right into the back-to-school season. So I feel very confident in the team I have to implement and drive that success from a market access perspective.

付款人確實需要相當長的時間，幾個月後他們才會考慮將其添加到處方集中。因此，我認為在推出後的前六個月，我們將確保在這六個月結束時覆蓋率達到 80% 以上，Roanna，這將使我們直接進入返校季。因此，我對我所帶領的團隊從​​市場准入的角度實施和推動這一成功充滿信心。

Sounds good. Thanks a lot.

聽起來不錯。多謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So a couple for me. First, can you talk to any learnings that you've gleaned from the launch of neffy? I know it's fairly early days, but maybe you can talk to the extent to which that product is expanding the market and what you think that could mean for Anaphylm?

謝謝。對我來說這是一對。首先，您能談談從 neffy 的推出中獲得的經驗嗎？我知道現在還為時過早，但也許您可以談談該產品在多大程度上擴大了市場，以及您認為這對 Anaphylm 意味著什麼？

So that's number one. And then number two is on the potential for an Ad Comm. Maybe give us a reminder of how you're thinking about that? In other words, what do you think are sort of the key salient topics that would come up in an Ad Comm to the extent there is one?

這是第一點。第二個是關於廣告通訊的潛力。也許可以提醒我們一下您對此是怎麼想的？換句話說，您認為在 Ad Comm 中會出現哪些關鍵突出話題？

Sure, David. So I'll hand it over to Sherry in a second here again to give you her thoughts on what she obviously, her and her team are on a daily basis of watching the market. But I will say to you we do see the expansion in the market occurring that we would expect. In Q1 of this year, volumes were about 5% over last year.

當然，大衛。因此，我馬上就將時​​間交給雪莉 (Sherry)，讓她談談她和她的團隊每天對市場的觀察。但我要告訴你，我們確實看到市場正在發生我們預期的擴張。今年第一季度，交易量比去年同期成長了約5%。

And we do expect, as you've heard me say many times, this market to at least double over the years to come. So I'll let Sherry give you her thoughts and then I'll address the Ad Comm for you as well.

正如你們多次聽到我說過的那樣，我們確實預計，未來幾年這個市場規模將至少翻倍。因此，我會讓雪莉告訴你她的想法，然後我也會為你解決廣告委員會的問題。

David, great question. Again, I go back to my EpiPen days, whenever I took over that brand, we were at about $150 million to $200 million in sales. I think one of the things that we learned very quickly is the absolute critical nature of market expansion.

大衛，這個問題問得好。再說一次，回想我接手 EpiPen 的那些日子，每當我接手這個品牌時，我們的銷售額都在 1.5 億到 2 億美元左右。我認為我們很快學到的一件事就是市場擴張的絕對關鍵性。

And we were able, through market expansion efforts, disease state awareness, patient engagement and calling on the HCPs and that you're able, this market is promotionally sensitive. And so we saw increases of 25% back in kind of the mid 2010, '11, '12, mark.

我們能夠透過市場擴張努力、疾病狀態意識、患者參與和呼籲 HCP 來實現這一點，而且這個市場對促銷很敏感。因此，我們在 2010 年中期、2011 年和 2012 年看到了 25% 的增幅。

And so look, at the end of the day, neffy is doing the same, as Dan mentioned, the more messaging that's out there, the better for all of us. And so I think that they're doing absolutely the right thing. They went out to the physicians first as they're gaining payer access to drive demand.

所以，從根本上來說，neffy 所做的也是同樣的事情，正如 Dan 所提到的，傳遞的訊息越多，對我們所有人來說就越好。所以我認為他們所做的事情絕對正確。他們首先聯繫醫生，因為他們正在獲得付款人的訪問權限來推動需求。

And now you're seeing a more patient engagement social media marketing, and they've announced publicly that they're launching a big DTC campaign. Again, that is fantastic. What is the saying, a rising tide rises all boats. And I think it will benefit all of us.

現在，你看到了更具耐心的參與社群媒體行銷，他們已經公開宣布他們正在啟動一項大型 DTC 活動。再說一次，這真是太棒了。俗話說，水漲船高。我認為這對我們所有人都有好處。

Thanks, Sherry. I'll hand it over to Carl in a second for his thoughts on the Ad Comm. What I would say in terms of the topics, the specific topics, obviously, we don't know. But I would just remind you, we've had extensive interaction with the FDA.

謝謝，雪莉。我馬上就把它交給卡爾，請教他對 Ad Comm 的看法。就主題而言，我想說的是哪些具體主題，顯然我們不知道。但我只想提醒你，我們與 FDA 進行了廣泛的互動。

We've been very transparent about the discussions we've had with the FDA. So I think the issues for topics that we would expect at the Ad Comm, I think, are pretty well documented. But Carl can give his thoughts on how we're preparing, where we are in that work?

我們對與 FDA 的討論非常透明。因此，我認為我們在 Ad Comm 上預期討論的主題問題都有很好的記錄。但是卡爾可以就我們如何準備以及我們目前的工作進展發表他的看法嗎？

Yeah. Thanks, Dan. And David, thank you for the question. It's an important question. And I would just state that this is probably the most robust data set conducted to date for an epinephrine product. We've had over a 930 or so dosings, probably 800-plus singles and 125 repeat doses.

是的。謝謝，丹。大衛，謝謝你的提問。這是一個重要的問題。我只想說，這可能是迄今為止針對腎上腺素產品進行的最可靠的數據集。我們已經進行了超過 930 次劑量注射，其中大概有 800 多次單劑量注射和 125 次重複劑量注射。

It's a comprehensive NDA that was submitted difficult to know what the FDA may request of us, but we are fully prepared to respond to whatever those questions may be. And we are in the midst of aggressively preparing for anything that they may want further information on.

這是一份全面的保密申請，我們很難知道 FDA 可能會向我們提出什麼要求，但我們已經做好了充分的準備來回答這些問題。我們正在積極準備，以應對他們可能想要了解更多資訊的情況。

I would say that this is the first oral epinephrine product. So depending on how they get excited by that and what kind of questions I may have, we'll be happy to respond in due course.

我想說這是第一個口服腎上腺素產品。因此，根據他們對此的興奮程度以及我可能提出的問題類型，我們將很樂意在適當的時候做出回應。

Okay, I'll leave it there thank you.

好的，我就不說了，謝謝。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·菲茨杰拉德。

Hi, good morning, everybody. I wanted to ask how you envision division head for this pulmonology allergy space could potentially influence both in Ad Comm and the review process? And outside of Dr. Seymour of the people you've been engaging even before you filed as you currently filed, would you say that there are other changes as well?

大家好，早安。我想問一下，您認為這個肺科過敏部門的部門主管可能會對 Ad Comm 和審查過程產生怎樣的影響？除了西摩博士之外，在您提交申請之前和目前提交申請之前，您還認為還有其他變更嗎？

Sure. Good morning Kristen, we and our interactions have not dealt with the division head. We have had the deputy division head as the person who oversaw the interactions. And as of today, and obviously, the FDA is an evolving organization in today's environment.

當然。早安，克里斯汀，我們和我們的互動還沒有與部門主管打交道。我們有副部門主管來監督這些互動。截至今天，顯然，FDA 已成為當今環境下不斷發展的組織。

But as of today, the review team and the Deputy Director all remain the same for our program, and those were also the same people for the program that came before us. So from a review process standpoint, all the interactions we've had so far suggests that things are in a normal state, which is positive, we believe.

但截至今天，我們專案的審查團隊和副主任仍然沒有變化，而且他們也仍然是我們先前專案的審查人員。因此，從審查過程的角度來看，到目前為止我們進行的所有互動都表明事情處於正常狀態，我們相信這是積極的。

In terms of the Ad Comm, as we've stated before, the best I can tell you is we are ready. We want to have an Ad Comm. We are ready. We hope it happens. I do have some doubts, I will tell you on whether the government is in a position to make things happen for an Ad Comm, but we will be ready, and we hope it does happen.

關於廣告委員會，正如我們之前所說，我能告訴你的最好的事情就是我們已經準備好了。我們想要有一個廣告委員會。我們準備好了。我們希望它能夠實現。我確實有一些疑問，我會告訴你政府是否有能力讓 Ad Comm 的事情發生，但我們會做好準備，我們希望它確實會發生。

Thank you so much.

太感謝了。

Jason Butler, Citizens JMP.

傑森‧巴特勒 (Jason Butler)，公民 JMP。

Hi, thanks for taking the questions. Two for me. First of all, can you just talk about where you think awareness of Anaphylm with providers is today and how you're measuring or assessing how that awareness is building throughout the year or heading into the launch?

你好，謝謝你回答這個問題。對我來說是兩個。首先，您能否談談您認為目前供應商對 Anaphylm 的認知度如何，以及您如何衡量或評估這種認知度在全年或在發布前如何建立？

And then secondly, just when you think about the seasonality of the market as well as the time taken to get payer access, how should we think about the adoption curve in the first few months of the launch? Thank you.

其次，當您考慮市場的季節性以及獲得付款人訪問權限所需的時間時，我們應該如何考慮推出後的前幾個月的採用曲線？謝謝。

Sure. So I'll pass it over to Sherry for both of those items.

當然。因此我將把這兩件物品交給雪莉 (Sherry)。

Jason, as we think about Anaphylm and knowing that we certainly have created transformational epinephrine for patients and our caregivers as the only non-device oral epinephrine physicians are very, very excited about the product. So we've done upwards of 1,000 interviews with patients and HCPs alike.

傑森，當我們想到 Anaphylm 時，我們知道我們確實為患者和照護者創造了轉化腎上腺素，作為唯一不使用設備的口服腎上腺素醫生，我們對該產品感到非常非常興奮。因此，我們對患者和醫療保健人員進行了 1,000 多次訪談。

There continues to be incredible excitement. As Dan mentioned, we are, from a medical perspective, engaging heavily with KOLs and the allergy community. So I believe our awareness is growing significantly.

令人難以置信的興奮仍在繼續。正如丹所提到的，從醫學角度來看，我們正在與 KOL 和過敏社區密切合作。所以我相信我們的意識正在顯著增強。

We did conduct a baseline ATU trial at the end of December. And so we are measuring how that awareness continues to grow.

我們確實在 12 月底進行了基線 ATU 試驗。因此，我們正在衡量這種意識的持續成長。

But that is where all of our focus is right now as, again, Dan and Carl's team have really been engaged in being at a variety of not only the big conferences, the big allergy conferences but also state and regional conferences to share the exciting brand that we have for patients suffering from severe allergic reactions. So I feel really good about the awareness and how it is growing to prepare us for a fantastic launch in early Q1 of '26.

但這正是我們現在關注的重點，因為丹和卡爾的團隊一直致力於參加各種會議，不僅是大型會議、大型過敏會議，還有州和地區會議，以分享我們為患有嚴重過敏反應的患者提供的令人興奮的品牌。因此，我對這種認識感到非常高興，它正在不斷增長，為我們在 2026 年第一季初的出色發布做好了準備。

As it relates to your second question, how do we think about seasonality? This market is pretty tried and true. You start to see the pickup in the April, May time frame. It really peaks again August and September in that back-to-school time frame.

與您的第二個問題相關，我們如何看待季節性？這個市場已經經過了充分的檢驗。您會在四月和五月期間開始看到回升。在開學季的 8 月和 9 月，這一數字再次達到頂峰。

And so as we've mentioned previously, we are engaging with the payers now. As soon as there is approval, we will work to have the contracting complete as quickly as possible.

正如我們之前提到的，我們現在正在與付款人接觸。一旦獲得批准，我們將努力盡快完成承包。

I do think that you can look to the neffy curve to a certain degree to say it will probably follow this similar uptake. The payers take their time. They some have blocks for the first handful of months, but we will have other ways for patients to access the medication.

我確實認為，你可以在一定程度上觀察尼菲曲線，並說它可能會遵循類似的吸收。付款人需要花費一些時間。有些人在最初幾個月會遇到困難，但我們會透過其他方式讓患者獲得藥物。

Now with that being said, I do feel super confident by that back-to-school season, we will have the majority of the market covered for our access, and that will be the most important time. So that August, September, October time frame. Does that answer your question?

話雖如此，我確實非常有信心，到了開學季，我們的覆蓋範圍將涵蓋大部分市場，那將是最重要的時刻。所以那是八月、九月、十月的時間範圍。這回答了你的問題嗎？

That's great.

那太棒了。

Ram Selvaraju, H.C. Wainwright.

拉姆·塞爾瓦拉朱（H.C.）溫賴特。

Thanks very much for taking my question. Firstly, on Anaphylm, I wanted to ask if you could comment on your thoughts regarding direct-to-consumer advertising strategies that would be most appropriate to support this product?

非常感謝您回答我的問題。首先，關於 Anaphylm，我想問您是否可以評論一下關於最適合支持該產品的直接面向消費者的廣告策略的想法？

What those might look like, specifically how they might be similar to analogous to or differ from the DTC advertising that's been used in support of neffy so far? And also, if you could give us a sense of when in the launch trajectory, you consider it most appropriate to deploy such strategies? Thank you.

它們看起來是什麼樣的，具體來說，它們與迄今為止用於支援 neffy 的 DTC 廣告有何相似、類似或不同之處？另外，您能否告訴我們，在發射軌跡中，您認為何時部署此類策略最為合適？謝謝。

Rob, I'll hand it over to Sherry in a second to talk about when we would deploy it, but let me give you some just general thoughts on DTC awareness. I think especially in a space like this, DTC is important for awareness, right?

羅布，我馬上就把話題交給雪莉來討論我們何時部署它，但讓我先給你一些關於 DTC 意識的一般想法。我認為，尤其是在這樣的領域，DTC 對於意識來說非常重要，對嗎？

It is a great way to drive awareness around the disease state and to drive people to their physician to ask about what they should be doing. If you listen and watch a lot of DTC advertising, oftentimes, the product isn't as prominently focus in that DTC as it is the awareness of the disease.

這是提高人們對疾病狀況的認識並促使人們向醫生詢問他們應該做什麼的好方法。如果你聽過、看過很多 DTC 廣告，你會發現，很多時候，產品並不是 DTC 中關注的重點，而是疾病的認知。

So we actually believe, and I'll borrow from Sherry's statement before, we firmly believe that a rising tide raises all boats in this particular market. This is a very large market. It's an expanding market, and we believe that the DTC efforts of anyone in this market helps the overall group.

因此，我們確實相信，我借用雪莉之前的話來說，我們堅信，在這個特定的市場中，水漲船高。這是一個非常大的市場。這是一個不斷擴大的市場，我們相信這個市場中任何人的 DTC 努力都會對整個集團有所幫助。

So in terms of our positioning, look, if you take away anything from today's call, it should be that we are focused, and we're focused on making sure that we are in the physician's offices where we can win, where we can make sure our scripts start to flow and that will be the number one priority. DTC well, I don't want to steal Sherry's thunder, so I'll let her talk about where we would layer in DTC.

因此，就我們的定位而言，如果你從今天的電話會議中得到什麼啟示，那就是我們應該集中精力，確保我們在醫生辦公室裡能夠獲勝，確保我們的處方開始流通，這將是第一要務。DTC 好吧，我不想搶雪莉的風頭，所以我會讓她談談我們將在 DTC 中分層的位置。

Yeah, it's a great question, Ram. So again, when you think about a launch, first and foremost, physicians have to be aware of the product. And so the focus is typically heavy physicians for the first several months.

是的，這是一個很好的問題，拉姆。所以，當你考慮推出新產品時，首先，醫生必須了解該產品。因此，頭幾個月的重點通常是重症醫師。

While you're also in parallel beginning the DTC effort. So social media, digital advertising, working very hard with the patient advocacy groups that can make patients aware.

同時您也正在同時開始 DTC 工作。因此，社群媒體、數位廣告以及與患者權益團體的密切合作可以讓患者意識到這一點。

So if you think about, it's kind of (inaudible) as I'm thinking, I should say, of the launch of Anaphylm. I'm thinking of it in three buckets. One is awareness, the second is preparedness and the third is access.

所以如果你想想，這有點（聽不清楚），就像我在想，我應該說，Anaphylm 的推出。我從三個方面考慮這個問題。一是意識，二是準備，三是獲取。

So awareness is critical. Awareness of the HCP is critical. A physician has to be aware of the product, know how to write the product, know what to expect.

因此，意識至關重要。對 HCP 的認識至關重要。醫生必須了解產品，知道如何編寫產品，並知道會發生什麼。

And so again, that's what you've seen with our competitor. That's what you see really with most pharma brands that are very DTC focused. While that is happening, patients are also being made aware through, again, social media, digital advertising, print advertising and now radio advertising has come back on the market.

所以，這就是您在我們的競爭對手身上看到的。這就是大多數專注於 DTC 的製藥品牌所真正看到的情況。同時，患者也透過社群媒體、數位廣告、平面廣告和重新上市的廣播廣告獲得了認知。

And so patients are becoming aware. So you have an intersection where the patients are in the offices, they are speaking with the physicians, you have the sales reps out there.

因此患者開始意識到這一點。因此，您有一個交集，患者在辦公室，他們與醫生交談，而銷售代表也在那裡。

We've we're working to make more and more physicians aware of the product. And so you have this intersection where a physician is ready to prescribe and the patient is ready to receive. So again, first and foremost, is that HCP promotion, you start to layer in more and more DTC promotion as your coverage or market access coverage increases.

我們正在努力讓越來越多的醫生了解這個產品。因此，你會看到這樣的交叉點：醫生準備開處方，而病人則準備接受治療。因此，首先也是最重要的一點是，隨著覆蓋範圍或市場准入覆蓋範圍的擴大，您會開始分層增加 HCP 推廣。

And so you would expect that and just like you're seeing with our competitors, they'll be out eight months, they're starting to talk about their heavy DTC campaign. You would start to that's how really big brands think of direct-to-consumer, and that's based on my experience as well.

因此，您可以預料到這一點，就像您看到我們的競爭對手一樣，他們已經八個月沒有再談論大規模的 DTC 活動了。你會開始明白，這就是大品牌對直接面向消費者的看法，這也是基於我的經驗。

And then just following on from that, I was wondering if you could just describe for us the distribution infrastructure and the channel that's likely to be used in support of Anaphylm as and when the product gets approved for the US?

然後，接下來我想知道您是否可以為我們描述一下 Anaphylm 的分銷基礎設施和可能用於支援該產品的管道，以及當該產品在美國獲得批准時？

And also, if you could talk a little bit, particularly in the context of the most favored nation pricing construct, how you are thinking about optimizing the opportunity for Anaphylm outside the United States and what you currently consider to be the most highest value territories for the product ex US?

另外，如果您可以稍微談談，特別是在最惠國定價結構的背景下，您如何考慮優化 Anaphylm 在美國以外的機會，以及您目前認為該產品在美國以外價值最高的地區是哪些？

Sure, Ram. Let me go in almost reverse order. So I'll leave Sherry the distribution infrastructure in the US. But let me address the most favored nation comment you made, which I think is in reference to the executive order that we saw come out yesterday from the White House.

當然，拉姆。讓我以幾乎相反的順序來講述。所以我會把美國的分銷基礎設施留給雪莉。但是，請容許我談談您關於最惠國待遇的評論，我認為這是針對我們昨天看到的白宮發布的行政命令而言的。

From our perspective for companies like us who are up and coming, are agile, are looking to be disruptive and different, there's nothing but opportunity in some of the different ways that things seem to be evolving. As you saw in that executive order there was actually a mention of finding ways to cut out the middleman.

從我們的角度來看，對於像我們這樣正在崛起、敏捷、尋求顛覆和與眾不同的公司來說，事物發展的某些不同方式中充滿了機會。正如你在該行政命令中看到的，其中實際上提到了尋找擺脫中間人的方法。

We would love that, right? I don't know if it's completely practical in today's world. But those are things that we, as a smaller flexible company, love and would like to take advantage of this time goes on. In terms of outside the US, and Ram, as you know, that's really just data and data is public.

我們會喜歡的，對吧？我不知道它在當今世界是否完全實用。但作為一家規模較小、靈活的公司，我們喜歡這些，並且希望利用這些優勢。就美國以外而言，正如你所知，Ram，這實際上只是數據，而且數據是公開的。

The biggest markets to focus on are Canada, the UK and Germany. So that's why we've said that our international interactions this year with regulatory bodies will be Canada, the UK and EMEA. So we've lined those up with where we see the value ex US. With that, I'll let Sherry take on the distribution.

需要關注的最大市場是加拿大、英國和德國。這就是為什麼我們說今年我們與監管機構的國際互動將是加拿大、英國和歐洲、中東和非洲。因此，我們已將這些與我們所看到的美國以外的價值進行了排列。這樣，我就讓雪莉負責分送。

And as you know, Anaphylm is absolutely transformation will be upon approval, absolutely transformational for patients and caregivers alike. What we do know is this is still predominantly a retail-driven product in the (inaudible) of health and happiness distribution through the retail channel.

如您所知，Anaphylm 一旦獲得批准，對於患者和照護者來說絕對是一種變革。我們所知道的是，這仍然主要是透過零售通路分銷健康和幸福產品的零售驅動產品（聽不清楚）。

However, our market access will be brought on specifically based on her experience looking at and using alternate distribution channels and models. And so we are assessing the different ways in which a customer patient or a caregiver can access Anaphylm. And so yes, you would expect it to be in your local CVS and Walgreens, but you can also expect to see other ways in which a patient will be able to access Anaphylm.

然而，我們的市場准入將基於她研究和使用替代分銷管道和模式的經驗。因此，我們正在評估顧客患者或照護者使用 Anaphylm 的不同方式。所以是的，你會期望它出現在你當地的 CVS 和 Walgreens 藥局，但你也可以期待看到患者能夠透過其他方式獲得 Anaphylm。

Thank you.

謝謝。

Gary Nachman, Raymond James.

蓋瑞納赫曼、雷蒙詹姆斯。

This is Denis Reznik on for Gary Nachman. Thanks for taking our questions. So first for Anaphylm ex US, if you're looking for a partner there, would you want them to do the regulatory submissions in those international markets? Or would that be something that you would take on your own?

這是加里·納赫曼 (Gary Nachman) 的丹尼斯·雷茲尼克 (Denis Reznik)。感謝您回答我們的問題。那麼首先對於 Anaphylm ex US 來說，如果您正在那裡尋找合作夥伴，您是否希望他們在這些國際市場上進行監管提交？還是這是你自己會做的事情？

And then is the ex US partnership something that you hear about this year? And then when we think about the US commercialization launch, can you just talk a little bit more about what your ideal early adopter prescriber of Anaphylm looks like? And I've got one follow-up.

那麼，您今年聽說過有關前美國合夥企業的消息嗎？然後，當我們考慮美國商業化發佈時，您能否再多談談您理想的 Anaphylm 早期採用者處方者是什麼樣的？我還有一個後續問題。

Thanks, Denis. So I'll let Sherry in a minute talk about how she thinks about HCP in patients and the ideal adopters. In terms of the ex US regulatory submission strategy, that is definitely partner dependent. But I would say that we have an excellent regulatory team that does a phenomenal job, not just here in the US, but in our interactions around the world.

謝謝，丹尼斯。因此，我將讓雪莉 (Sherry) 稍後談談她對患者的 HCP 以及理想採用者的看法。就美國以外的監管提交策略而言，這肯定依賴於合作夥伴。但我想說，我們擁有一支優秀的監管團隊，不僅在美國，而且在我們與世界各地的互動中都做得非常好。

As you know, from our previous engagements and partnerships, we have extensive experience ex US. And so the engagement with regulatory bodies and even submitting ex US is not an issue for us to support. And again, that would be more partner based on what the right setup would be.

如您所知，從我們以前的合作和夥伴關係來看，我們在美國以外擁有豐富的經驗。因此，與監管機構的合作甚至提交美國以外的文件都不是我們需要支持的問題。再次強調，這將基於正確的設定而獲得更多的合作夥伴。

In terms of timing, Denis, I learned long ago in this role that timing is a dangerous thing when it comes to partnerships. What I would tell you is that we are very active on engaging on that front.

丹尼斯，就時機而言，我很久以前就在這個職位上認識到，當涉及到合作關係時，時機是一件危險的事情。我想告訴你們的是，我們在這方面的參與非常正面。

And that as we learn more and as we understand how that will evolve, we'll communicate as we can. With that, I'll let Sherry take on the adopters.

隨著我們了解更多情況並理解其將如何發展，我們將盡可能地進行溝通。這樣，我就讓雪莉來負責收養那些人了。

Denis, thanks for the question. It's a great question. As we have done more than 1,000 interviews with HCPs and patients, even most recently, what we continue to hear is that there is still an enormous unmet need for a non-device that is discrete, convenient, easy to carry and easy to use. And so while there are more choices now, there is still a tremendous unmet need.

丹尼斯，謝謝你的提問。這是一個很好的問題。我們已經對 1,000 多名 HCP 和患者進行了採訪，甚至最近，我們不斷聽到的是，對於獨立、方便、易於攜帶和易於使用的非設備仍然存在巨大的未滿足需求。因此，儘管現在有了更多的選擇，但仍然存在巨大的未滿足的需求。

As Dan mentioned in his earlier comments, it is not atypical for us to have parents, teenagers and physicians come up to us at the conferences and say, oh my gosh, I would absolutely carry this. I can put it on the back of my phone. It's like an extension of myself.

正如丹在他之前的評論中提到的那樣，在會議上，經常會有家長、青少年和醫生來找我們說，‘天哪，我絕對會接受這個治療’，這並不罕見。我可以把它放在手機背面。它就像是我自己的延伸。

And so it fits -- Anaphylm film will fit into patient's lifestyle, I believe, better than any product that is currently on the market. And so as we think about who our early adopters will be, what we're thinking is that, first of all, it's the physicians that are seeing the majority of patients, it's the physicians that are hearing from their patients or their patients' mothers that my kids still doesn't carry.

所以它非常適合——我相信 Anaphylm 薄膜比目前市場上的任何產品都更適合患者的生活方式。因此，當我們思考誰會成為我們的早期採用者時，我們想到的是，首先，是那些接待大多數患者的醫生，是那些從他們的患者或患者的母親那裡聽說我的孩子還沒有攜帶病毒的醫生。

My kid doesn't want a device. And so we believe that the adoption will be in early prescribers of our competitor as well as those physicians who continue to hear that patients want an oral medication.

我的孩子不想要設備。因此，我們相信，我們競爭對手的早期處方者以及那些繼續聽到患者想要口服藥物的醫生將會採用這種方法。

And I'll just leave you with this. In some of our market research that we did with physicians, 95% of physicians believe that a film dosing option fills an unmet need in the epinephrine market. 9.5 out of 10 physicians. That's a lot of doctors and 85% have told us to date that they will prescribe a film dosing option, and they expect their prescriptions to increase.

我就把這個留給你們吧。在我們與醫生進行的一些市場調查中，95％的醫生認為薄膜給藥選項滿足了腎上腺素市場尚未滿足的需求。 10 位醫生中，有 9.5 位。有許多醫生，其中 85% 的人告訴我們，到目前為止，他們會開出薄膜給藥方案，他們預計處方量會增加。

And so while I left a bit boil the ocean and be able to impact tens of thousands of physicians, we are going to have a very targeted, very focused approach to call on being the highest decile prescription in order to drive that early adoption and that early revenue stream. Does that answer your question?

因此，雖然我留下了一些想法，並能夠影響成千上萬的醫生，但我們將採取非常有針對性、非常集中的方法來呼籲最高十分位的處方，以推動早期採用和早期收入流。這回答了你的問題嗎？

Yeah. That is super helpful. And then just one quick follow-up on the top line pediatric data that you had previously presented. When you look at the geometric mean adjusted epinephrine concentration between the pediatric and adults, can you just provide a little bit more color as to why the pediatric patients perhaps saw an increase earlier than the adults and then why they didn't reach the same high concentration?

是的。這非常有幫助。然後，我們再快速跟進您之前提供的兒科頂級數據。當您觀察兒童和成人之間的幾何平均調整腎上腺素濃度時，您能否提供更多細節來解釋為什麼兒童患者的腎上腺素濃度可能比成人更早增加，以及為什麼他們沒有達到相同的高濃度？

Yeah. I'm going to pass it over to Carl. But just to reiterate, our view on the pediatric data, we think the pediatric data is exactly in line with expectations and is supportive of the product having a label down to very kilos but I'll let Carl give you some more specific thoughts.

是的。我要把它交給卡爾。但只是重申一下，我們對兒科數據的看法，我們認為兒科數據完全符合預期，並支持產品的標籤精確到公斤，但我會讓卡爾給你一些更具體的想法。

Yes. No, I appreciate the question. I would just remark that the data that we've evaluated is completely in line with what we had expected and hoped for based on the known characteristics of the adult dosing. And statistically, there is no difference that we found to be of any clinical significance.

是的。不，我很感謝你提出這個問題。我只想說，我們評估的數據完全符合我們根據已知的成人劑量特徵所預期和希望的數據。從統計學上看，我們發現沒有任何具有臨床意義的差異。

So I appreciate the observation. But when you look at the data in detail, it's completely in line with our hopes and our expectations. We are very excited about the data.

所以我很欣賞這個觀察。但當你詳細查看數據時，它完全符合我們的希望和期望。我們對這些數據感到非常興奮。

Great. Thanks so much.

偉大的。非常感謝。

Nelson Cox, Lake Street Capital Markets.

納爾遜·考克斯 (Nelson Cox)，Lake Street Capital Markets。

Great, thanks for taking questions and this is Nelson on for Thomas. First one, just wondering maybe quickly if you can talk about the cash you believe you'll need for the launch of Anaphylm? Just any commentary there I think would be helpful.

太好了，感謝您回答問題，以下是納爾遜 (Nelson) 代替托馬斯 (Thomas) 發言。首先，我只是想知道您是否可以快速談談您認為推出 Anaphylm 所需的現金？我認為任何評論都會有幫助。

Sure. Well, I'll pass it over to Ernie in a second, but let me just frame cash because that's a really important piece for launch, right? First, I would remind everyone especially as this company has evolved over the last few years, we have something of incredible value, and we are focused on making sure that we maximize that value for our shareholders.

當然。好吧，我馬上就把它交給厄尼，但讓我先把現金框起來，因為這對發射來說是一個非常重要的環節，對吧？首先，我要提醒大家，特別是在公司過去幾年的發展過程中，我們擁有一些非常有價值的東西，我們專注於確保為股東最大化價值。

So we're actually very excited about where we are, especially from where we've come from. And we think we have a lot of optionality that we did not have when I look back several years ago. But I'll let Ernie give you a little bit more specifics around that.

因此，我們對於現在的處境感到非常興奮，特別是對於我們來自哪裡。我們認為，我們擁有很多選擇權，而這些選擇權是我幾年前回顧時所沒有的。但我會讓厄尼向您提供有關這方面的更多細節。

Sure, Nelson. So we have, as Dan said, something very valuable. And with that, we have a number of paths to help finance the launch. And just to reiterate, we have said we are not hiring on sales rep until we have approval.

當然，尼爾森。因此，正如丹所說，我們擁有一些非常寶貴的東西。這樣，我們就有多種途徑來資助這次發射。再次重申，我們說過，在獲得批准之前，我們不會招募銷售代表。

We will do all the preparatory work to all the precommercial work this year, but we will not spend money on sales reps until we have approval, and then we will ramp up to be prepared to sell as soon as possible. Our cash provides us runway in through this year and the initial stages of that launch next year.

我們今年將做好所有商業化前期工作的準備工作，但在獲得批准之前，我們不會在銷售代表上花錢，然後我們將盡快做好銷售準備。我們的現金為我們今年以及明年啟動初期提供了支撐。

But we have a number of levers to pull on how rapidly we spend our cash. And also as the previously mentioned opportunities to partner Anaphylm outside the US refinancing our debt, all these nondilutive ways to help fund the launch. So we feel we're in a good position to be prepared for next year.

但我們可以透過多種手段來控制花錢的速度。還有前面提到的與美國以外的 Anaphylm 合作為我們的債務進行再融資的機會，所有這些非稀釋性的方式都有助於為此次發布提供資金。因此，我們認為我們已經做好了明年的準備。

Perfect. That's helpful. And then maybe just a two parter quick. Will you recognize any Libervant revenue in the second quarter? I know it would probably be minimal, but any commentary there? And then when is the earliest you might know about advisory committee meeting?

完美的。這很有幫助。然後可能只是兩個快速的部分。您會在第二季確認任何 Libervant 收入嗎？我知道這可能很小，但是有什麼評論嗎？那麼，您最早什麼時候可能知道諮詢委員會會議？

The revenue for Libervant in the second quarter is minimal. And just to reiterate what I said in my comments, our guidance for this year has, revised guidance, we've essentially taken out Libervant completely for the rest of the year.

Libervant 第二季的營收微乎其微。為了重申我在評論中所說的話，我們對今年的指導已經進行了修訂，我們基本上已經在今年剩餘時間內完全取消了 Libervant。

The revenue we reported even for the first quarter is not significant, even though we were making great progress on ramping up Libervant, but we're not reporting a significant amount of revenue for this year for Libervant. But importantly, we are taking out expenses that will add incrementally to our cash for the rest of the year.

儘管我們在擴大 Libervant 業務方面取得了巨大進展，但我們報告的第一季收入並不可觀，但我們報告的 Libervant 今年的收入並不可觀。但重要的是，我們正在削減開支，這將在今年剩餘時間內逐步增加我們的現金。

And Carl, do you want to take your thoughts on when (inaudible) in An Comm?

卡爾，你想在 An Comm 中談談你對（聽不清楚）的看法嗎？

But sure. So the FDA, the division, in particular, clearly had liberty to alert us at any time, but we are certainly hopeful they would do so by day 74, but it's obviously, it's at their discretion.

但當然。因此，FDA，特別是其部門，顯然有權隨時向我們發出警報，但我們當然希望他們能在第 74 天之前發出警報，但這顯然由他們自行決定。

Great, thanks for taking the questions guys.

太好了，謝謝大家回答問題。

James Molloy, Alliance Global Partners.

聯盟全球合作夥伴的詹姆斯‧莫洛伊 (James Molloy)。

Matt (inaudible) on for Jim. So about the potential partnerships ex US for distribution Anaphylm. How would you characterize the partnership environment currently?

馬特（聽不清楚）代替吉姆。關於美國以外地區 Anaphylm 經銷的潛在合作夥伴關係。您如何描述目前的合作環境？

And in terms of AQST-108, when would you anticipate potentially reprioritizing that clinical development? Should we look at it in some time in '27 post launch of Anaphylm? Thanks.

就 AQST-108 而言，您預計何時可能重新調整臨床開發的優先順序？我們是否應該在 Anaphylm 推出後的 27 年某個時候再研究它？謝謝。

Thanks, Matt. Let me go in reverse order. I just want to reiterate, and I made this comment earlier, but I want to make sure I make it clearly. I believe 108 is a great product. I believe it's a big opportunity for the company there.

謝謝，馬特。讓我按相反的順序講。我只是想重申，我之前已經發表過這個評論，但我想確保我說得清楚。我相信 108 是一款很棒的產品。我相信這對那裡的公司來說是一個巨大的機會。

I think the science is very interesting and is science that we can deliver and be transformative in another area. So in no way are we backing away from how much we like 108. But there's millions of dollars that we were going to spend on 108 this year that are better off in the hands of Sherry and our Anaphylm launch.

我認為科學非常有趣，我們可以在其他領域應用並帶來改變。因此，我們絕不會放棄對 108 的喜愛。但是，我們今年要在 108 上花費數百萬美元，而這些錢交給 Sherry 和我們的 Anaphylm 發射部門來管理會更好。

So my goal, my desire is to get back to prioritizing 108 as soon as possible but we will not do that in any way that sacrifices any ability to launch Anaphylm the best way we can. In terms of the partnership environment outside the US, I would say it's active. You obviously saw our competitor have a deal in Europe with another company.

所以我的目標、我的願望是盡快回到優先順序 108，但我們不會以任何犧牲以最佳方式推出 Anaphylm 的能力的方式來做到這一點。就美國以外的合作環境而言，我認為是活躍的。您顯然看到我們的競爭對手在歐洲與另一家公司達成了交易。

There are other companies that are interested in being in that market, and we're in discussions with the right people. So we'll continue to push that along, and we'll tell you more as we know more.

還有其他公司對進入該市場感興趣，我們正在與合適的人進行討論。因此，我們會繼續推動這一進程，並在了解更多資訊後告訴您。

Great, okay, thank you guys for taking the questions.

太好了，好的，謝謝大家回答這些問題。

And I'm not showing any further questions at this time. I'd like to turn the call back over to Dan for any closing remarks.

我現在不想再問任何問題。我想將電話轉回給丹，讓他做最後的總結發言。

Thanks, Kevin. And hopefully, the theme you've heard from us today came through loud and clear, which is we are focused on the launch of Anaphylm and that's the right place to be for this company at this time with a filing in at the FDA and the launch clock ticking down.

謝謝，凱文。希望您今天聽到的主題清晰明確，那就是我們專注於 Anaphylm 的上市，目前對我們公司來說，這是正確的時機，因為需要向 FDA 提交申請，上市時間正在接近。

We appreciate you joining us this morning. And I look forward to updating you everyone as we progress through our Anaphylm FDA review period, and as Sherry and her team continue to prepare for launch. With that, I wish all of you a great rest of your day.

感謝您今天上午加入我們。我期待向大家通報 Anaphylm FDA 審查階段的進展情況，以及 Sherry 和她的團隊繼續為產品發布做準備的情況。最後，我祝福大家今天過得愉快。

Thank you. Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.

謝謝。女士們、先生們，今天的演講到此結束。現在您可以斷開連接，享受美好的一天。