Aquestive Therapeutics Inc (AQST) 2025 Q2 法說會逐字稿

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

您好，感謝您的支持。歡迎參加 Aquestive Therapeutics 2025 年第二季財報電話會議（操作員指示）請注意，今天的會議正在錄製中。

I'd like to hand the conference over to your first speaker today, Brian Korb. Please go ahead.

我想將會議交給今天的第一位發言者 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 are going to provide an overview of recent business developments and performance for the second 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, Chief Commercial Officer.

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 和財務長 Ernie Toth 也與我一起出席。我們將概述 2025 年第二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 博士和首席商務官 Sherry Korczynski 將加入團隊。

As a reminder, the company's remarks today correspond with the earnings release that was issued after the market closed yesterday. In addition, a recording of today's call will be made available on the 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 網站的投資者部分發布。

To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of second-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 年第二季業績審查的一部分。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 be making forward-looking statements. We remind you of this company's Safe Harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the Risk Factors section and in other sections included in the company's quarterly report on the Form 10-Q filed with the Securities Exchange Commission on August 11, 2025.

在電話會議期間，公司將做出前瞻性陳述。我們提醒您注意該公司在昨天的收益報告中概述的安全港語言，以及影響該公司的風險和不確定性，如該公司在 2025 年 8 月 11 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 in 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.

與任何正在開發候選產品和正在商業化產品的製藥公司一樣，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都存在重大風險和不確定性。

Given these uncertainties, you should not place undue reliance on these forward-looking statements which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday.

鑑於這些不確定性，您不應過度依賴這些前瞻性陳述，因為這些陳述僅代表截至作出之日的觀點。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明確受本警告聲明和昨天發布的收益報告中包含的警告聲明的完整限制。

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.

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陳述的義務，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 less than six months away from our FDA action date for Anaphylm epinephrine sublingual film, potentially the first and only oral product for the treatment of severe allergic reactions, including anaphylaxis.

謝謝，布萊恩，大家早安。現在距離 Anaphylm 腎上腺素舌下膜的 FDA 核准日期還有不到六個月的時間，該產品可能是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）的口服產品。

As a reminder, our action date is scheduled for January 31, 2026. I'm pleased to tell you this morning that we are on track across the important elements of Anaphylm. We are on track in our FDA review process, our Anaphylm advisory committee preparations, which may or may not occur, and our pre-commercial launch activities. We are on track in responsibly securing launch financing for the company, and we are on track in our international expansion efforts for Anaphylm.

提醒一下，我們的行動日期定於 2026 年 1 月 31 日。今天早上我很高興地告訴大家，我們在 Anaphylm 的重要元素方面進展順利。我們的 FDA 審查流程、Anaphylm 諮詢委員會的準備工作（可能發生也可能不會發生）以及商業化發布前的活動均按計劃進行。我們正在以負責任的方式為公司爭取啟動融資，並且我們正在為 Anaphylm 進行國際擴張努力。

Let's start with the FDA review of our Anaphylm application. We recently submitted our 120-day safety update to the FDA. I'm pleased to say that there was nothing new or of consequence to report in this safety update. We also believe the FDA is about to conclude its mid-cycle review.

讓我們從 FDA 對我們的 Anaphylm 申請的審查開始。我們最近向 FDA 提交了 120 天安全性更新。我很高興地說，這次安全更新中沒有什麼新的或重要的內容需要報告。我們也認為 FDA 即將完成其中期審查。

While we do not participate in this review, we would expect to have more clarity on whether we will have an advisory committee meeting once the FDA has fully processed its mid-cycle review meeting. In terms of advisory committee meeting preparations, we recently completed our first in-house mock or practice advisory committee meeting, including participation from our key opinion leaders.

雖然我們沒有參與此次審查，但我們希望在 FDA 全面處理中期審查會議後，能夠更清楚地了解我們是否會召開諮詢委員會會議。在諮詢委員會會議準備方面，我們最近完成了第一次內部模擬或練習諮詢委員會會議，包括我們的關鍵意見領袖的參與。

We were pleased with the results and continued to strengthen our discussion points every week. It's also worth noting that we have included our pediatric study data in the supplemental materials on our website. As we have discussed before, this data was in line with expectations and importantly enabled us to submit our NDA for patients down to 30 kilograms for approximately seven years of age.

我們對結果感到滿意，並繼續每週加強我們的討論要點。另外值得注意的是，我們已將兒科研究數據納入我們網站的補充資料中。正如我們之前所討論的，這些數據符合預期，重要的是使我們能夠為大約七歲、體重低至 30 公斤的患者提交 NDA。

Now let's turn to our pre-commercial activities. As a starting point, it's important to remember that we continue to believe the rescue market for severe allergic reactions is poised for growth for years to come. Before the launch of a nasal spray last year, there had been very little innovation and very little physician detailing in this space for quite some time.

現在讓我們來談談我們的商業化前活動。首先，重要的是要記住，我們仍然相信嚴重過敏反應的救援市場在未來幾年將保持成長勢頭。在去年推出鼻噴劑之前，很長一段時間內，該領域的創新很少，醫生的詳細介紹也很少。

When we launch, if we are approved by the FDA, there will be only a few companies detailing physicians and highlighting the need for patients to carry and use rescue medications for severe allergic reactions. I believe that this, along with the underlying market growth, should propel the market from roughly 5 million prescriptions a year to as many as 10 million prescriptions a year.

當我們推出產品時，如果我們獲得 FDA 的批准，將只有少數公司詳細介紹醫生並強調患者攜帶和使用嚴重過敏反應的救援藥物的必要性。我相信，這一點，加上潛在的市場成長，應該會推動市場從每年約 500 萬張處方增加到每年 1,000 萬張處方。

Using the estimated current net prices of today's epinephrine products, this could be as much as or more than $2 billion a year in global market. A recent survey conducted by an expert research analyst in this space concluded that 90% of the market will move from injectables to non-injectable products over the years to come.

根據目前腎上腺素產品的估計淨價，全球市場每年的銷售額可能高達甚至超過 20 億美元。該領域的一位專家研究分析師最近進行的一項調查得出結論，未來幾年 90% 的市場將從注射劑轉向非注射劑產品。

And in our surveys, we found that when patients are presented with a choice between injectables, nasal sprays and oral films, they favor the convenience, size, durability, and oral administration of Anaphylm. We believe this market remains a compelling opportunity for Aquestive and its stakeholders, especially patients and caregivers, if approved by the FDA.

在我們的調查中，我們發現，當患者在註射劑、鼻噴劑和口腔膜劑之間做出選擇時，他們更喜歡 Anaphylm 的便利性、尺寸、耐用性和口服給藥。我們相信，如果獲得 FDA 批准，這個市場對於 Aquestive 及其利害關係人（尤其是患者和照護者）來說仍然是一個極具吸引力的機會。

Let's focus on patients and caregivers for a moment. According to one of the leading allergy advocacy groups, the Allergy & Asthma Network, an estimated 225 Americans die each year from anaphylaxis. Sadly, it seems that this rate has not improved in decades.

讓我們暫時關註一下患者和照護者。根據領先的過敏倡導組織之一過敏與氣喘網絡的統計，估計每年有 225 名美國人死於過敏性休克。可悲的是，幾十年來這一比率似乎沒有改善。

We believe the way to improve bad outcomes is to, one, improve the carry rate; two, lower the barrier to use; and three, ensure broad availability and coverage. We think the inherent characteristics of Anaphylm will address the first two items because Anaphylm fits patients' lives.

我們認為，改善不良後果的方法是：一、提高攜帶率；二、降低使用門檻；三、確保廣泛的可用性和覆蓋範圍。我們認為 Anaphylm 的固有特性將解決前兩個問題，因為 Anaphylm 適合患者的生活。

Unfortunately, the third item, market access, is harder. We have been disappointed to see the number of barriers that the most recently approved epinephrine product has faced when it comes to market access. Pricing and product access should not prevent patients from having access to life-saving medicines.

不幸的是，第三項，即市場准入，更加困難。我們很失望地看到，最近批准的腎上腺素產品在市場准入方面面臨著如此多的障礙。定價和產品取得不應阻止患者獲得救命的藥物。

Delay tactics, NDC blocks and prior authorization documentation are just a few ways that payers make it hard for patients to get the drugs that they need. And for pharmaceutical manufacturers like us, these barriers add significant costs to putting our products into the hands of patients.

拖延策略、NDC 阻止和事先授權文件只是付款人使患者難以獲得所需藥物的幾種方式。對於我們這樣的製藥商來說，這些障礙增加了將產品送到病人手中的成本。

Simply put, Americans are not getting the coverage they expect through the healthcare insurance that they paid for. In fact, some companies have indicated that the average healthcare plan deductible for a single person has risen from roughly $900 in 2010 to $1,800 in 2024, and it is still climbing. As you can imagine, the deductibles are considerably higher for a family.

簡而言之，美國人並沒有透過他們所支付的醫療保險來獲得他們期望的保障。事實上，一些公司表示，個人醫療保健計劃的平均免賠額已從 2010 年的約 900 美元上漲至 2024 年的 1,800 美元，並且仍在攀升。你可以想像，對一個家庭來說，免賠額高很多。

That is why for Anaphylm, we will be taking a patient first approach. On day one, we will have a cash pay program available to patients and caregivers. While we are not announcing our pricing today, we will do everything we can to make sure that patients have immediate access to Anaphylm even if their provider puts up barriers to access. We will share more details on this program as we get closer to approval and launch.

這就是為什麼對於 Anaphylm，我們將採取患者至上的方法。第一天，我們將為患者和照護者提供現金支付計劃。雖然我們今天不會宣布定價，但我們會盡一切努力確保患者能夠立即獲得 Anaphylm，即使他們的供應商設置了獲取障礙。隨著我們越來越接近批准和啟動，我們將分享有關該計劃的更多細節。

Additionally, our market access group possesses significant enterprise level pricing, contracting, coding and reimbursement, trade and distribution, patient services, and government affairs experience. The team is engaging with payers as you would expect at this point in the approval process of Anaphylm.

此外，我們的市場准入團隊擁有豐富的企業級定價、合約、編碼和報銷、貿易和分銷、病患服務和政府事務經驗。正如您所期望的，在 Anaphylm 審批流程的這個階段，團隊正在與付款人接觸。

Now let's turn to financing the launch. As you saw in our press release, we ended the last quarter with $60 million in cash. While this is sufficient for the initial launch, we will need more funding to appropriately support Anaphylm. Ernie will talk more about our financials, but I do want to give you my perspective on our pathways to financing the launch.

現在讓我們來討論發射的融資問題。正如您在我們的新聞稿中看到的，上個季度結束時我們擁有 6000 萬美元的現金。雖然這對於初始啟動來說已經足夠了，但我們需要更多的資金來適當支持 Anaphylm。厄尼將更多地談論我們的財務狀況，但我確實想向您介紹我們為此次發射融資的途徑。

We currently have multiple proposals in process, including for EU-only rights and alternate financing vehicles. We are working through the pathways available to the company and we'll select the best pathway when the time is right. However, as of today, we remain confident that launch financing is available to the company and that we will have secured financing prior to launch.

我們目前正在製定多個提案，包括僅限歐盟的權利和替代融資工具。我們正在研究公司可用的途徑，並在適當的時候選擇最佳途徑。然而，截至今天，我們仍然相信公司可以獲得啟動融資，我們將在啟動之前獲得融資。

The final update for Anaphylm is on the international front. We have secured meetings in both Canada and the EU for discussion on the filing packages necessary with each regulatory body. Our plan remains to complete these meetings by the end of the year and then begin the work to prepare and submit filings.

Anaphylm 的最終更新是在國際方面。我們已經安排在加拿大和歐盟舉行會議，討論向每個監管機構提交所需文件的情況。我們的計劃仍然是在年底前完成這些會議，然後開始準備和提交文件的工作。

Regarding the remainder of our business, we continue to make progress. We continue to believe AQST-108, our epinephrine topical gel could provide a compelling improvement for patients with alopecia areata. We are on track to open our IND with the FDA before the end of the year and begin our next human studies in early 2026.

關於我們剩餘的業務，我們將繼續取得進展。我們仍然相信 AQST-108，我們的腎上腺素外用凝膠可以為斑禿患者帶來顯著的改善。我們預計在今年年底前向 FDA 提交 IND，並在 2026 年初開始下一項人體研究。

Our base business grew year over year in the second quarter when adjusted for one-time revenue events. This was driven by strong growth in our international products. We continue to work towards offsetting the decline of Suboxone with new business opportunities.

經一次性收入事件調整後，我們第二季的基礎業務較去年同期成長。這是由我們國際產品的強勁成長所推動的。我們將繼續努力透過新的商業機會來抵消 Suboxone 的衰退。

In conclusion, we remain on track for a launch of Anaphylm in the first quarter of 2026, if approved by the FDA. Our focus remains on our interactions with the FDA, finalizing our launch financing and pre-commercial activities.

總之，如果獲得 FDA 批准，我們仍有望在 2026 年第一季推出 Anaphylm。我們的重點仍然是與 FDA 的互動，最終確定我們的上市融資和商業化前活動。

Now I will turn the call over to Ernie.

現在我將把電話轉給厄尼。

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 second quarter of 2025 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 2025 年第二季業績相關的大部分內容。

During the second 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, is not a device, is orally administered, and it's easy to carry. This includes supporting pre-approval launch activities for Anaphylm to increase awareness among physicians, payers, and the advocacy community as we approach the PDUFA action date of January 31, 2026.

在第二季度，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，是口服的，而且易於攜帶。這包括支持 Anaphylm 的上市前啟動活動，以便在我們接近 2026 年 1 月 31 日的 PDUFA 行動日期時提高醫生、付款人和倡導社區的認識。

As Dan mentioned, we continue to evaluate all financing alternatives to support the commercial launch of Anaphylm if approved by the FDA. This includes non-dilutive alternatives such as the sale of global rights, EU-only rights, refinancing our existing debt, additional debt, as well as revenue interest financing.

正如丹所提到的，如果獲得 FDA 批准，我們將繼續評估所有融資替代方案，以支持 Anaphylm 的商業化上市。這包括非稀釋性替代方案，例如出售全球權利、僅限歐盟的權利、再融資現有債務、額外債務以及收入利息融資。

We are evaluating all options to find the best financing structure to support the future growth of Aquestive. Aquestive's manufacturing business remains steady with the gradual decline of Suboxone being offset by growth across newer collaborations, including for the licensed products Ondif, Sympazan and Emylif.

我們正在評估所有選擇，以找到最佳的融資結構來支持 Aquestive 的未來發展。Aquestive 的製造業務保持穩定，Suboxone 的逐漸下滑被新合作的成長所抵消，包括許可產品 Ondif、Sympazan 和 Emylif。

Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the company being a US-based manufacturer with intellectual property domiciled in the US, has a supply chain which currently remains unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production and global distribution for the near term.

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。此外，該公司是一家總部位於美國的製造商，其智慧財產權位於美國，其供應鏈目前不受已實施和擬議關稅的影響，可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 second-quarter results. Excluding the impact of one-time recognition of deferred revenue in the second quarter of 2024, total revenues increased by $0.3 million or 3% year over year to $10 million in the second quarter of 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreement.

現在讓我們來看看第二季的業績。不包括 2024 年第二季一次性確認遞延收入的影響，2025 年第二季總營收年增 30 萬美元，即 3%，達到 1,000 萬美元。提醒一下，上一年一次性確認遞延收入是由於許可和供應協議的終止。

Including the deferred revenue recognized in the prior year, total revenues decreased to $10 million in the second quarter of 2025 from $20.1 million in the second quarter of 2024. Manufacture and supply revenue increased to $9.6 million in the second quarter of 2025 from $8.1 million in the second quarter of 2024, primarily due to increases in Ondif revenues partially offset by decreases in Suboxone revenues.

包括前一年確認的遞延收入，總收入從 2024 年第二季的 2,010 萬美元減少至 2025 年第二季的 1,000 萬美元。製造和供應收入從 2024 年第二季的 810 萬美元增至 2025 年第二季的 960 萬美元，主要原因是 Ondif 收入的增加，但 Suboxone 收入的減少部分抵消了這一增長。

Total revenues decreased to $18.7 million for the six months ended June 30, 2025 from $32.2 million for the six months ended June 30, 2024, due to one-time recognition of deferred revenue in the prior year. Excluding this one-time recognition of deferred revenue, total revenues decreased by $2.8 million or 13% year to year.

由於上一年一次性確認了遞延收入，總收入從截至 2024 年 6 月 30 日的六個月的 3,220 萬美元減少至截至 2025 年 6 月 30 日的六個月的 1,870 萬美元。不包括這一次性確認的遞延收入，總收入年減 280 萬美元，即 13%。

Manufacture and supply revenue decreased to $16.8 million for the six months ended June 30, 2025, from $18.6 million for the six months ended June 30, 2024, primarily due to decreases in Suboxone revenues partially offset by increases in Ondif revenues. Research and development expenses in the second quarter of '25 remain relatively consistent compared to the second quarter of 2024.

製造和供應收入從截至 2024 年 6 月 30 日的六個月的 1860 萬美元減少至截至 2025 年 6 月 30 日的六個月的 1680 萬美元，主要原因是 Suboxone 收入減少，但被 Ondif 收入增加部分抵消。與 2024 年第二季相比，2025 年第二季的研發費用保持相對穩定。

Research and development expenses decreased to $9.5 million for the six months ended June 30, 2025, from $10.1 million for the six months ended June 30, 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial cost associated with the continued advancement of the Anaphylm program, partially offset by increases in personnel costs and an increase in share-based compensation.

截至 2025 年 6 月 30 日的六個月，研發費用從截至 2024 年 6 月 30 日的六個月的 1,010 萬美元減少至 950 萬美元。研發費用的減少主要是由於 Anaphylm 計畫的持續推​​進導致臨床試驗成本的下降，但被人員成本的增加和股權激勵的增加部分抵消。

Selling, general and administrative expenses increased to $12.7 million in the second quarter of 2025 from $11.4 million in the second quarter of 2024, primarily due to higher commercial spending for pre-launch activities of approximately $2 million, higher regulatory and licensing fees of approximately $0.8 million, higher personnel costs of approximately $0.4 million, higher share-based compensation expenses of approximately $0.2 million and higher consulting fees of approximately $0.2 million, partially offset by lower legal fees of approximately $2.5 million and lower insurance expenses of $0.2 million.

銷售、一般及行政開支從 2024 年第二季度的 1,140 萬美元增至 2025 年第二季度的 1,270 萬美元，主要由於上市前活動的商業支出增加約 200 萬美元、監管和許可費用增加約 80 萬美元、人員成本增加約 40 萬美元、股權激勵費用萬美元和保險費用減少約 20 萬美元部分抵消了這些影響。

Selling, general and administrative expenses increased to $31.8 million for the six months ended June 30, 2025, from $22 million for the six months ended June 30, 2024. The increase primarily represents regulatory fees related to the Anaphylm PDUFA fee of approximately $4.3 million, higher commercial spending on pre-launch activities for Anaphylm of approximately $4.2 million, higher regulatory and licensing fees of approximately $1.5 million, higher personnel costs of approximately $0.8 million, higher share-based compensation expenses of approximately $0.5 million, and higher consulting fees of approximately $0.3 million, all partially offset by decreases in severance costs of approximately $1.1 million, lower insurance expenses of approximately $0.5 million, and lower legal fees of approximately $0.4 million.

截至 2025 年 6 月 30 日的六個月，銷售、一般及行政開支從截至 2024 年 6 月 30 日的六個月的 2,200 萬美元增至 3,180 萬美元。增加的部分主要包括與 Anaphylm PDUFA 費用相關的監管費用約 430 萬美元、Anaphylm 上市前活動商業支出增加約 420 萬美元、監管和許可費用增加約 150 萬美元、人員成本增加約 80 萬美元、股權激勵費用增加約 50 萬美元以及諮詢費用增加約 30 萬美元，但減少約 50 萬美元、成本40 萬美元部分抵銷。

Aquestive's net loss for the second quarter 2025 was $13.5 million or $0.14 for both basic and diluted loss per share compared to the net loss for the second quarter of 2024 of $2.7 million or $0.03 for both basic and diluted loss per share. Excluding the impact of one-time recognition of deferred revenue, the net loss in the second quarter of 2024 was $13.2 million.

Aquestive 2025 年第二季的淨虧損為 1,350 萬美元，即每股基本虧損和稀釋虧損均為 0.14 美元，而 2024 年第二季的淨虧損為 270 萬美元，即每股基本虧損和稀釋虧損均為 0.03 美元。剔除一次性確認遞延收入的影響，2024年第二季淨虧損為1,320萬美元。

Aquestive's net loss for the six months ended June 30, 2025, was $36.5 million or $0.37 for both basic and diluted loss per share compared to the net loss for the six months ended June 30, 2024, of $15.6 million or $0.19 for both basic and diluted loss per share. Excluding the impact of one-time recognition of deferred revenue, the net loss for the six months ended June 30, 2024, was $26 million.

截至 2025 年 6 月 30 日的六個月，Aquestive 的淨虧損為 3,650 萬美元，即每股基本虧損和稀釋虧損均為 0.37 美元，而截至 2024 年 6 月 30 日的六個月的淨虧損均為 1,560 萬美元，即每股基本虧損和稀釋虧損均為 0.99 美元。不包括一次性確認遞延收入的影響，截至2024年6月30日的六個月的淨虧損為2,600萬美元。

Non-GAAP adjusted EBITDA loss was $9.3 million in the second quarter of 2025 compared to non-GAAP adjusted EBITDA income of $1.8 million in the second quarter of 2024. Excluding the impact of the one-time recognition of deferred revenue, non-GAAP adjusted EBITDA loss in the second quarter of 2024 was $8.6 million.

2025 年第二季非 GAAP 調整後 EBITDA 虧損為 930 萬美元，而 2024 年第二季非 GAAP 調整後 EBITDA 營收為 180 萬美元。不包括一次性確認遞延收入的影響，2024 年第二季非 GAAP 調整後 EBITDA 虧損為 860 萬美元。

Non-GAAP adjusted EBITDA loss was $27 million for the six months ended June 30, 2025, compared to non-GAAP adjusted EBITDA loss of $5.4 million for the six months ended June 30, 2024. Again, excluding the impact of one-time recognition of deferred revenue, non-GAAP adjusted EBITDA loss for the six months ended June 30, 2024, was $15.8 million. Cash and cash equivalents were $60.5 million as of June 30, 2025.

截至 2025 年 6 月 30 日的六個月，非 GAAP 調整後 EBITDA 虧損為 2,700 萬美元，而截至 2024 年 6 月 30 日的六個月，非 GAAP 調整後 EBITDA 虧損為 540 萬美元。同樣，不包括一次性確認遞延收入的影響，截至 2024 年 6 月 30 日的六個月的非 GAAP 調整後 EBITDA 虧損為 1580 萬美元。截至 2025 年 6 月 30 日，現金及現金等價物為 6,050 萬美元。

Aquestive's full-year 2025 financial guidance remains unchanged. The company expects total revenue of $44 million to $50 million and non-GAAP adjusted EBITDA loss of $47 million to $51 million.

Aquestive 的 2025 年全年財務指引保持不變。該公司預計總收入為 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. As a reminder, our 2024 revenue included one-time non-recurring 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針對 2 至 5 歲兒童的 Libervant 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 guides for 2025 includes significant pre-approval launch 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 的指導包括 Anaphylm 的大量上市前批准支出、最近提交 Anaphylm NDA 的相關費用和相關申請費、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，我現在將把電話轉回給接線生，以便大家可以提問。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員指示）Roanna Ruiz，Leerink Partners。

Hello. Yes. Good morning. So just wanted to touch base -- this is Mazi on for Roanna Ruiz, but just wanted to touch base. So we mentioned the possible FDA AdCom meeting ahead of the PDUFA. Could you provide any more details on the likelihood of the ad com being required and how confident you are in your clinical data package going into this?

你好。是的。早安.所以只是想聯繫一下——這是 Mazi 為 Roanna Ruiz 做的報導，只是想聯繫一下。因此，我們提到了在 PDUFA 之前可能召開的 FDA AdCom 會議。您能否提供更多有關需要廣告委員會的可能性的詳細信息，以及您對臨床數據包的信心如何？

Sure, and this is Mazi, right?

當然，這是 Mazi，對嗎？

Yes, it is.

是的。

Nice to hear your voice. So in terms of the likelihood of an AdCom, nothing has changed on that front since our last conversation. As you know, the FDA obviously accepted our application back in June where they reiterated that they may or may not want to have an advisory committee meeting.

很高興聽到你的聲音。因此，就 AdCom 的可能性而言，自從我們上次談話以來，這方面沒有任何變化。如您所知，FDA 顯然在 6 月接受了我們的申請，他們重申他們可能想或可能不想召開諮詢委員會會議。

By our math, the FDA should be just about in the process of having its mid-cycle review. And we would continue to believe that in the coming weeks to a month to, call it, we would have an indication from them whether they want an AdCom or not. So again, from our perspective, the important part is to be ready, and we have focused a lot of energy and time on making sure that we are ready for any AdCom if the FDA desires.

根據我們的計算，FDA 應該處於中期審查階段。我們仍然相信，在未來幾週到一個月內，我們會從他們那裡得到是否想要 AdCom 的暗示。因此，從我們的角度來看，重要的是做好準備，我們投入了大量的精力和時間來確保我們為 FDA 所需的任何 AdCom 做好準備。

In terms of how we feel about our clinical package, I will pass it over to Carl to give you his high-level view.

關於我們對臨床方案的感受，我將把它交給卡爾，讓他向你們提供他的高層次觀點。

Yeah. Appreciate the question. And I believe we may have commented on that last discussion as well, which is that the package is quite robust. We probably have one of the largest epinephrine studies conducted to date. The package consists of 10 independent studies, well over 930-plus exposures and well over 350 subjects.

是的。感謝你的提問。我相信我們可能也對上次討論發表了評論，那就是該計劃非常強大。我們可能進行了迄今為止規模最大的腎上腺素研究之一。該項目包括 10 項獨立研究、超過 930 項曝光和超過 350 個主題。

It's a robust package. It should be able to address any and all potential questions that the agency may have. So we're very proud of it, and we believe it's a strong package.

這是一個強大的軟體包。它應該能夠解決該機構可能遇到的任何和所有潛在問題。因此我們對此感到非常自豪，我們相信這是一個強大的方案。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So just have a couple. Interested in your comments regarding out-of-pocket exposure for patients and just the payer landscape. And I guess my question here is, is your commentary a function not only of what you're seeing with your competitor, the nasal spray formulation, but also a function of your discussions with payers? Maybe talk to the extent of your discussion with payers, how that's going and how you're thinking about access issues. So that's number one.

謝謝。所以只要幾個就可以了。我對您關於患者自付費用和付款人情況的評論很感興趣。我想我的問題是，您的評論是否不僅取決於您對競爭對手鼻噴配方的看法，還取決於您與付款人的討論？也許可以談談您與付款人的討論程度、進展如何以及您如何看待訪問問題。這是第一點。

And then number two regarding the cash pay initiative. I guess my question here is how much of the intranasal business is actually cash pay? And what kind of cash pay market do you think is going to evolve into over time? And just trying to get a better understanding of your thought process here. Thank you.

第二個是關於現金支付計劃。我想我的問題是，鼻內業務中有多少實際上是現金支付的？您認為隨著時間的推移，現金支付市場將會演變成什麼樣的？只是想更好地理解你的思考過程。謝謝。

Sure. Thanks, David. Good morning. So let me start with what we're doing, right? So from discussion with payers, Sherry Korczynski, who's here with me this morning and her team have done a great job of engaging on payer landscape. We have some really solid expertise in-house. And so to the extent that the pre-commercial world allows you to engage with the payers, we are obviously engaged with the payers.

當然。謝謝，大衛。早安.那麼讓我先說一下我們正在做的事情，好嗎？因此，從與付款人的討論來看，今天早上和我一起來的 Sherry Korczynski 和她的團隊在參與付款人事務方面做得非常出色。我們內部擁有一些非常紮實的專業知識。因此，在商業化前的世界允許你與付款人接觸的範圍內，我們顯然也與付款人接觸。

Those discussions do not, at this time, get to a place where we talk about coverage or what that would look like. That's not obviously allowed until approval. So right now, our focus with payers is strictly on awareness.

目前，這些討論還沒有涉及到討論報道內容或報道內容是什麼樣子。顯然，未經批准是不允許的。因此，目前，我們對付款人的關注點完全是提高認識。

In terms of the out-of-pocket exposure in the payer landscape, my commentary would be for our entire industry. I don't think there's a single drug that gets launched right now that doesn't have concerns over how their patients get the product that they need without extreme or additional issues in the chain of getting a product. So I wouldn't say that is specific to just the nasal spray.

就付款人自付費用風險而言，我的評論針對的是整個產業。我認為現在推出的任何一種藥物都會讓人擔心患者如何獲得他們需要的產品，而不會在產品獲取鏈中出現極端或額外的問題。所以我不會說這只針對鼻腔噴劑。

In terms of cash pay, I'll leave it to our competitor to talk about what percentage of their business is cash pay or isn't cash pay. When we look across the landscape, our view is that cash pay is an important part of any product that is launching in the near term. And we think that given the trends of how the payer world works, that is likely to continue.

至於現金支付，我會讓我們的競爭對手來談論他們的業務中有多少比例是現金支付或不是現金支付。縱觀整個形勢，我們認為現金支付是近期推出的任何產品的重要組成部分。我們認為，考慮到付款人世界的運作趨勢，這種情況可能會持續下去。

Over time, we would expect for most drugs other than, call it, very highly priced drugs that the cash pay portion will continue to grow and be a significant portion. In terms of what it can ultimately be for Anaphylm, I think that will really be informed by the market.

隨著時間的推移，我們預計，除了價格非常高的藥物之外，大多數藥物的現金支付比例將繼續增長，並佔相當大的比重。至於 Anaphylm 的最終發展方向，我認為這將真正由市場決定。

That's helpful. If I may just sneak in a follow-up. To the extent that you're going to be buying down (technical difficulty) product right, this is in chronic treatment. As you think about that, where does co-pay buy down play into your overall strategy and how should we think about that? Thanks.

這很有幫助。如果我可以偷偷跟進的話。就您要購買（技術難度）產品權而言，這是一種慢性治療。當您考慮這一點時，共同支付買斷在您的整體策略中扮演什麼角色，我們應該如何看待這一點？謝謝。

Yeah. Look, our role right now, our job right now beyond getting the product approved and available to patients is to make sure that they have access in a reasonable fashion. So not just us [but] every company utilizes the co-pay buy-down program.

是的。你看，我們現在的角色，我們現在的工作除了讓產品獲得批准並提供給患者之外，還要確保他們能夠以合理的方式獲得產品。因此，不僅我們，每家公司都採用共同支付買斷計劃。

Obviously, the important part with the co-pay buy-down program is to make sure it's balanced, that you balance it with the coverage that you were either getting or have versus where you are at that stage. So I don't think you'll see us do anything that is out of the ordinary on co-pay buy-downs, but we absolutely will have it as a part of our world.

顯然，共同支付買斷計劃的重要部分是確保其平衡，即確保它與您當時所獲得或擁有的保險範圍相平衡。因此，我認為您不會看到我們在共同支付買斷方面採取任何不同尋常的舉措，但我們絕對會將其作為我們世界的一部分。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·費茲傑拉。

Hi. Good morning, everyone. Thanks for taking the question. So recently, former CRLs were made publicly available, including one from your peer who now has an approval. I know you're in a unique position because you're differentiated, but also you get to leverage that experience to help with your own prep.

你好。大家早安。感謝您回答這個問題。因此，最近，以前的 CRL 已公開，其中包括來自您的同行的現已獲得批准的 CRL。我知道你處於一個獨特的位置，因為你與眾不同，但你也可以利用這種經驗來幫助你自己做好準備。

So I'm curious if you reviewed any of these documents and anything that you can really gain from material beyond what we already knew, including from the AdCom experience?

所以我很好奇，您是否審查過這些文件，以及您是否能從我們已知的材料中獲得任何超出我們所知的信息，包括 AdCom 的經驗？

Sure. Thank you, Kristen. And yes, of course, one of the benefits of being second is you get to see what the person who was ahead of you or the company that was ahead of you went through. So both from an AdCom and a CRL perspective, we have definitely watched and tried to learn.

當然。謝謝你，克里斯汀。是的，當然，成為第二名的好處之一就是你可以看到在你之前的人或公司經歷了什麼。因此，無論從 AdCom 或 CRL 的角度來看，我們都在觀察並嘗試學習。

Our biggest learning -- and I'll focus on the CRL, though I think it played into the AdCom as well. Our biggest learning is an age old one for us. And as a reminder, we have six FDA approvals over the years, which is listen to the FDA. So our read of the CRL is there was a study that was not completely done the way that the FDA wanted it to be done, and our competitor had to go back and do that.

我們最大的收穫——我將重點關注 CRL，儘管我認為它在 AdCom 中也發揮了作用。我們最大的教訓是一個古老的教訓。提醒一下，這些年來我們已經獲得了六項 FDA 批准，這要聽從 FDA 的意見。因此，我們對 CRL 的解讀是，有一項研究並未完全按照 FDA 的要求進行，而我們的競爭對手必須回頭做這件事。

So in our package -- and Carl talked before about the completeness of our package -- one of the things we really focused on is making sure we did everything that the FDA asked for. So to be specific, in our oral allergy syndrome study, we did not just a single dose, but a repeat dose arm that was specifically listening to what the FDA had asked for and ties to the allergic rhinitis component of the CRL that you referenced.

因此，在我們的方案中——卡爾之前談到了我們方案的完整性——我們真正關注的事情之一是確保我們按照 FDA 的要求做了所有事情。具體來說，在我們的口腔過敏症候群研究中，我們不只是採用單劑量，而是採用重複劑量組，這專門聽取了 FDA 的要求，並與您提到的 CRL 中的過敏性鼻炎成分相關。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

Great. Good morning and thanks for taking our questions and the update here guys. Just a quick one on us you we see that you provided some additional details on the pediatric study, PK/PD, which is great. Can you give us a little bit more color on the safety, and then how confident are you in the submission for this part of the NDA submission? Thank you.

偉大的。早安，感謝大家回答我們的問題並提供最新資訊。我們只需簡單了解一下，就可以看到您提供了一些有關兒科研究 PK/PD 的額外詳細信息，這非常好。您能否向我們詳細介紹安全性，然後您對這部分 NDA 提交的信心有多大？謝謝。

Sure, well, and good morning, Andreas. I'll pass it over to Carl in a second here. I'll just open with -- as Carl said at the top of this Q&A session, we're confident in the package we put together. We think it's a robust package and the right one for what we're looking to accomplish. But I'll let Carl talk on the pediatric studies.

當然，早安，安德烈亞斯。我馬上就把它交給卡爾。我首先要說的是——正如卡爾在本次問答環節開始時所說的那樣，我們對我們制定的方案充滿信心。我們認為這是一個強大的方案，並且適合我們想要實現的目標。但我會讓卡爾談論兒科研究。

Yeah. No. Thanks for the question. The pediatric study was crafted in such a way, really, just to provide characterization of the concentration time curve in the PK profile in that population. There was no internal competitor per se that was agreed upon with the agency, but we have done cross-study evaluations showing that it's quite comparable to the adult dose. And as you saw in the supplementary slides, you can almost see overlapping concentration time curves between the pediatric and adult studies.

是的。不。謝謝你的提問。兒科研究的設計方式實際上只是為了描述該族群的 PK 曲線中的濃度時間曲線。雖然沒有與該機構達成一致的內部競爭對手，但我們已經進行了交叉研究評估，表明它與成人劑量相當。正如您在補充幻燈片中看到的，您幾乎可以看到兒科和成人研究之間的重疊濃度時間曲線。

So from that perspective, the powering, the addressing FDA's concerns and requests for the appropriate number of subjects and also the subsequent PK profile that we saw at the outcome, we're extremely pleased with those data. As far as safety goes, there was no difference really in the character of frequency or severity of outcomes that we saw in the pediatric population. So overall, quite in line with what we were hoping for and expected.

因此從這個角度來看，對於適當數量的受試者的支持、解決 FDA 的擔憂和要求以及我們在結果中看到的後續 PK 概況，我們對這些數據非常滿意。就安全性而言，我們在兒科族群中觀察到的結果的頻率或嚴重程度特徵實際上沒有差異。總體而言，這與我們的希望和預期完全一致。

Jason Butler, Citizens JMP.

傑森‧巴特勒 (Jason Butler)，公民 JMP。

Hi. Thanks for taking the questions. Two for me. The first one, you mentioned that you'd submitted the 120-day safety update. Just wondering if there has been any other substantial data analysis or information request from FDA during the review so far.

你好。感謝您回答這些問題。對我來說是兩個。第一個問題，您提到您已經提交了 120 天的安全性更新。只是想知道到目前為止 FDA 在審查過程中是否有任何其他實質性的數據分析或資訊請求。

And then second, on the commercial prep, you talked about the reimbursement piece. Can you also just talk about the work you've done to increase awareness of Anaphylm, and where you think you've -- whether or not you've moved the needle there? Thanks.

其次，關於商業準備，您談到了報銷部分。您能否也談談您為提高人們對 Anaphylm 的認識所做的工作，以及您認為您在這方面是否取得了進展？謝謝。

Good morning, Jason. Good to hear your voice. So on the first one, we have had the usual back and forth with the FDA that you would expect to date. There is nothing that I would describe as a major data set or anything to that standpoint beyond the standard 120-day safety update. In terms of our awareness activities, I'll turn it over to Sherry to give you.

早上好，傑森。很高興聽到你的聲音。因此，在第一個問題上，我們與 FDA 進行瞭如您所料的常規溝通。除了標準的 120 天安全更新之外，沒有什麼可以稱為主要資料集或任何符合這一觀點的東西。關於我們的宣傳活動，我將交給雪莉給你。

Sure. Thanks so much for your question. As Dan mentioned in his comments, we continue to drive significant awareness of the brand. And what we're hearing back is consistent. The feedback from the broader allergy community, both patients and HCPs, continues to be positive.

當然。非常感謝您的提問。正如丹在評論中提到的那樣，我們將繼續大力提升品牌知名度。我們聽到的回饋是一致的。來自更廣泛的過敏群體（包括患者和 HCP）的回饋仍然很積極。

We have been conducting CME, non-CME. We have published a number of -- we have had a number of posters and have been very active in the medical side of things being at local, regional and national conferences.

我們一直在進行 CME 和非 CME。我們已經發表了許多——我們已經製作了許多海報，並且在地方、地區和國家會議上非常活躍地參與醫學方面的活動。

So we have really spent the entire year increasing the awareness of Anaphylm. And at the end of the day, what the HCPs continue to tell us is that they love the product. They believe it will improve the carry rate and it will decrease the barriers to use.

因此，我們確實花了一整年的時間來提高人們對 Anaphylm 的認識。最後，HCP 們不斷告訴我們，他們很喜歡這個產品。他們相信這將提高攜帶率並減少使用障礙。

Raghuram Selvaraju, H.C. Wainwright & Co.

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

Good morning. This is Dan on for Ram. Thanks for taking our questions. So we were curious in terms of business development strategy related to Anaphylm. I requested planning to partner the drug ahead of regulatory applications in ex-US territories that wait until those filings have been submitted. And how is the question of thinking about ex-US pricing in the context of most favored nations? Thank you.

早安.這是丹 (Dan) 代替拉姆 (Ram)。感謝您回答我們的問題。因此，我們對 Anaphylm 相關的業務發展策略感到好奇。我請求在美國以外地區提交監管申請之前就計劃與該藥物合作，直到這些申請提交之後再進行。那麼，在最惠國的背景下，如何考慮美國以外的定價問題呢？謝謝。

Good morning, Dan. Thanks for the question. So we've been pretty open all along probably for the better part of a couple of years now. From our perspective, our number one job is to make sure that Anaphylm gets put into the hands of as many patients as they can be useful for.

早上好，丹。謝謝你的提問。因此，我們一直以來都保持著相當開放的態度，也許這幾年來大部分時間都是如此。從我們的角度來看，我們的首要任務是確保 Anaphylm 能夠惠及盡可能多的患者。

So from that perspective, we are always looking at how to have the broadest coverage and the broadest capabilities. Whether that is ultimately a launch just by the company or a launch in conjunction with another company is something we continue to talk through as I said in my comments at the beginning.

因此從這個角度來看，我們一直在研究如何實現最廣泛的覆蓋範圍和最廣泛的能力。正如我在一開始的評論中所說的那樣，我們將繼續討論這最終是由該公司單獨推出還是與其他公司聯合推出。

In terms of ex-US pricing and most favored nation pricing, I don't see -- well, I suppose it will have an impact on all companies in the space. I think the primary impact will be on the larger companies that have very expensive drugs. I think if you look at this rescue market, you have a rescue treatment that is usually only filled once a year, so it's not a chronic medication.

就美國以外的定價和最惠國定價而言，我認為不會——好吧，我想它會對該領域的所有公司產生影響。我認為主要影響將集中在那些擁有昂貴藥品的大型公司。我認為如果你看看這個救援市場，你會發現救援治療通常每年只需要填寫一次，所以它不是慢性藥物。

And the price point on the product is obviously way below some of the high-priced biologics or something like that. So I don't think we're the target of those activities, and I wouldn't expect them to be a major component of how things play out here.

而產品的價格顯然遠低於一些高價生物製劑或類似產品。所以我不認為我們是這些活動的目標，我也不認為它們會成為這裡事態發展的主要組成部分。

Gary Nachman, Raymond James.

蓋瑞納赫曼、雷蒙詹姆斯。

Hey, guys. Good morning. This is Denis Reznik on for Gary Nachman. Thanks for taking our questions. So in terms of the precommercial efforts, can you detail what the ideal physician who would be a top decile prescriber of Anaphylm looks like? Are there any characteristics about them that you highlight?

嘿，大家好。早安.這是丹尼斯·雷茲尼克 (Denis Reznik) 為加里·納赫曼 (Gary Nachman) 主持的節目。感謝您回答我們的問題。那麼，就商業化前期工作而言，您能否詳細說明一下 Anaphylm 處方量最高的理想醫生是什麼樣的？您認為他們有哪些特質值得強調？

And then just given some of the headwinds, it sounds like you're seeing on the payer landscape, are you still confident that you can likely get 80% coverage in the first six months of launch? Thanks so much.

那麼，考慮到付款方面臨的一些不利因素，您是否仍有信心在推出後的前六個月內獲得 80% 的覆蓋率？非常感謝。

Good morning, Denis. Let me take the second one first, and then I'll pass it over to Sherry for the ideal physician. So yeah, we are confident that from a payer perspective, we will have broad coverage and that that coverage will be competitive with the other products available in the space.

早安，丹尼斯。讓我先回答第二個問題，然後我會交給雪莉，讓她選擇一位理想的醫生。所以，是的，我們相信，從付款人的角度來看，我們將擁有廣泛的覆蓋範圍，並且該覆蓋範圍將與該領域的其他產品具有競爭力。

The 80% mark, I don't know how to feel about that, but I would generally say yes, we'll have broad coverage across most people. But why don't I pass it over to Sherry? She can give you her thoughts on the ideal physician.

80% 這個數字，我不知道該作何感想，但我通常會說是的，我們將廣泛覆蓋大多數人。但我為什麼不把它交給雪莉呢？她可以告訴你她對理想醫生的看法。

It's a good question. And I always like to say that this market is an inch deep at about 10,000 miles wide. And what I mean by that is you have a very, very broad range of physicians that prescribe epinephrine. Everyone from the primary care physician that on average prescribes one to two prescriptions to the allergist on average that prescribes 200-plus prescriptions annually.

這是個好問題。我總是喜歡說，這個市場只有一英寸深，卻大約有一萬英里寬。我的意思是，有很多醫生都會開腎上腺素處方。從平均每年開出一到兩張處方的初級保健醫生到平均每年開出 200 多張處方的過敏症專科醫生，每個人都是如此。

And so as we look at where our focus will be upon launch, it will certainly be in the allergist space. We know and I've worked with allergists for the better part of 15 years. We know how excited they are about the innovation that Anaphylm brings to the marketplace because they absolutely believe that patients will carry -- and if patients carry the product, then they're more likely to use the product at the first signs and symptoms.

因此，當我們考慮產品發佈時的重點時，我們肯定會關注過敏症領域。我們知道這一點，而且我與過敏症專家合作已有 15 年多了。我們知道他們對 Anaphylm 為市場帶來的創新感到多麼興奮，因為他們絕對相信患者會攜帶——如果患者攜帶該產品，那麼他們更有可能在出現最初跡象和症狀時使用該產品。

And because Anaphylm works so quickly, as you've seen in our data, again, the HCP allergists are very, very excited. Over time, we will look for scale. And you can only look as far as what our competitors have done as you think about that. But again, that allergist is our key target upon launch.

而且由於 Anaphylm 起效非常快，正如您在我們的數據中看到的那樣，HCP 過敏症專家再次感到非常非常興奮。隨著時間的推移，我們將尋求規模。當你思考這個問題時，你只能看看我們的競爭對手做了什麼。但再次強調，過敏症專科醫生是我們推出該產品的重點目標。

Thomas Flaten, Lake Street Capital Markets.

托馬斯·弗拉頓（Thomas Flaten），湖街資本市場。

Yeah. Thanks for taking the question. Just perhaps hanging on to the last question that was asked. I'm curious, Sherry, if you guys have done any post-neffy launch patient research just to try and better understand, what is it that activates that patient?

是的。感謝您回答這個問題。也許只是堅持回答最後提出的問題。雪莉，我很好奇，你們是否做過任何 Neffy 發布後的患者研究，只是為了嘗試更好地理解，是什麼激活了那個患者？

Is it a recommendation from a physician? Are they seeing ads out there? I'm just trying to understand who those patients are that are coming in and actually filling that prescription for a needle-free alternative.

這是醫生的建議嗎？他們在那裡看到廣告了嗎？我只是想了解那些來這裡就診並實際開立無針替代藥物處方的病人是誰。

Yeah. It's a good question. And I'm sure we'll hear more from the competition in their call. However, as we've looked at it and as we've talked to patients and physicians alike, patients want choice, first and foremost. And they want a choice that is easy to carry, easy to use.

是的。這是個好問題。我相信我們會在電話會議中聽到更多來自競爭對手的消息。然而，正如我們所看到的，正如我們與患者和醫生所交談的那樣，患者首先想要的是選擇。他們想要一個易於攜帶、易於使用的選擇。

And so as we think about this, the ability to, one, convince the physician that epinephrine is epinephrine is epinephrine. And I think our competition is doing a good job that alternative forms of epinephrine work. And then obviously, from a consumer perspective, moms who are the chief medical officers of the home want a medication and epinephrine that their kids will carry.

因此，當我們思考這個問題時，首先要讓醫生相信腎上腺素就是腎上腺素。我認為我們的競爭對手在替代形式的腎上腺素方面做得很好。顯然，從消費者的角度來看，身為家庭首席醫療官的媽媽們希望她們的孩子能夠隨身攜帶藥物和腎上腺素。

And so, again, as you think about the physicians and the patients and mom, they want a product that the patients will carry and have with them. And so I do believe that all of the consumer education, the direct-to-consumer that our competition has started, and is doing a great job of, quite frankly, is increasing that awareness. That will only help, as Dan mentioned in his opening comments, of the growth of the rescue market to ultimately prevent those deaths that occurred due to anaphylaxis.

所以，再說一次，當你想到醫生、病人和媽媽時，他們想要一個病人可以隨身攜帶的產品。因此，我確實相信，我們的競爭對手已經開始的所有消費者教育、直接面向消費者的行銷，坦白說，做得很好，正在提高這種意識。正如丹在開場白中提到的那樣，這只會有助於救援市場的成長，最終防止過敏反應而發生的死亡。

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

謝謝。我目前沒有其他問題。現在我想請 Dan Barber 作結束語。

Thank you, Marvin. Well, we appreciate everyone joining us this morning. As you heard, we remain excited about where we are and we're looking forward to continuing to update everyone on our progress in the weeks and months to come. Take care.

謝謝你，馬文。好吧，我們感謝大家今天早上加入我們。正如您所聽到的，我們對目前的狀況感到興奮，並期待在未來幾週和幾個月內繼續向大家通報我們的進展。小心。

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

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。