Aquestive Therapeutics Inc (AQST) 2022 Q4 法說會逐字稿

Good morning and welcome to the Aquestive Therapeutics Fourth Quarter and Full Year 2022 Conference Call. (Operator Instructions) As reminders this call is being recorded, and I turn the call over to your host for today's conference call, Bennett Watson of Westwicke Investor Relations. You may begin.

早上好，歡迎來到 Aquestive Therapeutics 第四季度和 2022 年全年電話會議。 （操作員說明）作為提醒，此電話正在錄音中，我將電話轉給今天電話會議的主持人，Westwicke Investor Relations 的 Bennett Watson。你可以開始了。

Thank you operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer and Ernie Toth, Chief Financial Officer who are going to provide an overview of recent business development and performance for the fourth quarter of 2022 followed by a Q&A session. During the Q&A session, the team will be joined by Steve Wargacki, Vice President of R&D and Ken Marshall, Chief Commercial Officer.

謝謝運營商。早上好，歡迎來到今天的電話會議。在今天的電話會議上，首席執行官丹·巴伯 (Dan Barber) 和首席財務官厄尼·托特 (Ernie Toth) 加入了我的行列，他們將概述最近的業務發展和 2022 年第四季度的業績，然後是問答環節。在問答環節，研發副總裁 Steve Wargacki 和首席商務官 Ken Marshall 將加入該團隊。

As a reminder, the company's remarks today correspond with their earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on Aquestive's website within the investor section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non GAAP financial measures this morning as part of its review of fourth quarter and full year 2022 results.

提醒一下，該公司今天的言論與他們昨天收市後發布的財報一致。此外，本次電話會議結束後不久，將在 Aquestive 網站的投資者部分提供今天電話會議的錄音。提醒您，Aquestive 團隊今天上午將討論一些非 GAAP 財務措施，作為其對 2022 年第四季度和全年業績審查的一部分。

A description of these measures along with the reconciliation to GAAP can be found in the earnings release issued yesterday, which is posted on the investor section of Aquestive's website. During the call the company will be making forward-looking statements. We remind you of the company's Safe Harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in yesterday's earnings release and in the risk factors section and in other sections, including the company's annual report on form 10k to be filed with the Securities Exchange Commission later this month. And in our quarterly reports on Form 10 Q and current reports on Form 8k filed with the SEC.

這些措施的描述以及與 GAAP 的對賬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。在電話會議期間，公司將發表前瞻性陳述。我們提醒您注意昨天收益發布中概述的公司安全港語言，以及昨天收益發布和風險因素部分以及其他部分（包括公司年度報告表格）中描述的影響公司的風險和不確定性10k 將於本月晚些時候提交給證券交易委員會。在我們向美國證券交易委員會提交的關於 10 Q 表格的季度報告和關於 8k 表格的當前報告中。

As with any pharmaceutical companies 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、產品的開發、監管批准和商業化以及與運營相關的其他事項存在重大風險和不確定性。

The impact of the ongoing COVID 19 pandemic is highly uncertain, and cannot be predicted with certainty or clarity. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as 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.

正在進行的 COVID 19 大流行的影響具有高度不確定性，無法確定或明確地預測。鑑於這些不確定性，您不應過分依賴這些前瞻性陳述，這些陳述僅以發表日期為準。實際結果可能與這些陳述存在重大差異。所有歸因於 Aquestive 或任何代表其行事的人的前瞻性陳述均由本警告性聲明明確限定。以及昨天發布的收益報告中包含的警示性聲明。

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.

公司沒有義務在本次電話會議之後更新其前瞻性陳述。無論是由於新信息、未來事件還是其他原因，適用法律要求的情況除外。

With that, I'll now turn the line over to Dan.

有了這個，我現在把電話轉給丹。

Thank you Bennett. The fourth quarter marked the culmination of a 7-month run of improvements and execution by the management team in 2022. I am incredibly proud of the progress the team made in the fourth quarter, and quite frankly since the company's leadership transition occurred in May of last year. In the fourth quarter, the Aquestive team advanced its Lead Pipeline product, AQST-109 epinephrine sublingual film, through a CMC focused end of phase two meeting with the FDA and a separate clinical and regulatory focus End-of-Phase 2 meeting also with the FDA. Moreover, we completed our registration batches on schedule and plan to have the required 12 months of stability before the end of 2023.

謝謝貝內特。第四季度標誌著管理團隊在 2022 年為期 7 個月的改進和執行工作的高潮。我為團隊在第四季度取得的進展感到無比自豪，坦率地說，自公司領導層交接發生在 2022 年 5 月以來去年。在第四季度，Aquestive 團隊通過與 FDA 舉行的以 CMC 為重點的第二階段末期會議以及與食品藥品監督管理局。此外，我們按計劃完成了註冊批次，併計劃在 2023 年底之前達到所需的 12 個月的穩定性。

Our commercial collaborations also continued to perform at a high level. We completed the license of Sympazan to Assertio surpass 150 million doses of shipped product and multiple licensees announced early payments to our debt holders to reduce our debt overhang and ended the fourth quarter with more cash than we had at the end of any other quarter last year.

我們的商業合作也繼續保持高水平。我們完成了 Sympazan 對 Assertio 超過 1.5 億劑裝運產品的許可，多個被許可方宣布提前向我們的債務持有人付款以減少我們的債務積壓，並在第四季度末獲得比去年任何其他季度末更多的現金.

In 2022, we executed on 3 significant non-dilutive deals that generated over $25 million in cash, significantly streamline our business to reduce ongoing costs, reduced our ongoing litigation through successfully winning a motion to dismiss and the Suboxone antitrust case and gained a tentative approval for Libervant, diazepam buccal film.

2022 年，我們執行了 3 項重大的非稀釋性交易，產生了超過 2500 萬美元的現金，顯著精簡了我們的業務以降低持續成本，通過成功贏得駁回動議和 Suboxone 反壟斷案減少了我們的持續訴訟，並獲得了初步批准對於Libervant，地西泮口腔膜。

We have also held true to our story. As I said to you during the second quarter earnings call in August, sometimes, the simplest stories can be the most compelling. In my view, a pharmaceutical company with existing revenue and to acute rescue medications under development that both have strong clinical results to date, as well as long patent lives is a simple and compelling story. This remains just as true today, as it was last summer. Now though it is time to focus on 2023. This is an exciting year for Aquestive, and there are several clear milestones that we remain focused on achieving.

我們也堅持我們的故事。正如我在 8 月份的第二季度財報電話會議上對您所說的那樣，有時，最簡單的故事可能是最引人注目的。在我看來，一家擁有現有收入和正在開發的急救藥物的製藥公司，迄今為止都具有強大的臨床效果，而且專利壽命長，這是一個簡單而引人注目的故事。今天仍然如此，就像去年夏天一樣。現在是時候關注 2023 年了。對於 Aquestive 來說，這是令人興奮的一年，我們仍然專注於實現幾個明確的里程碑。

The first is continuing the rapid progression of AQST-109. We are currently in the clinic and anticipate having additional clinical data in the coming weeks as we shared in December. This data will help us determine the reference list of products that we will use in our pivotal study. Once we have the results we need, we will send a revised pivotal protocol to the FDA for its comments. Once we have received the agency's comments, we will start our pivotal study.

首先是繼續 AQST-109 的快速進展。正如我們在 12 月分享的那樣，我們目前正在臨床中，預計在未來幾週內會獲得更多臨床數據。這些數據將幫助我們確定我們將在關鍵研究中使用的產品參考列表。一旦我們獲得所需的結果，我們將向 FDA 發送修訂後的關鍵協議以徵求其意見。一旦我們收到該機構的意見，我們將開始我們的關鍵研究。

As of today we continue to guide to a third quarter start to this study, with the goal of having a top line readout before the end of 2023. If achieved this will keep us on track for a mid-2024 NDA submission to the FDA.

從今天開始，我們將繼續指導這項研究在第三季度開始，目標是在 2023 年底之前獲得頂線讀數。如果實現這一目標，我們將按計劃在 2024 年年中向 FDA 提交新藥申請。

You will see us continue to be active in the allergy community in 2023. Last month, we participated in the annual conference for the American Academy of Allergy Asthma and Immunology, more commonly known as ACAAI, as previously disclosed our Scientific Advisory Board members presented 4 posters. This conference gave us the opportunity to interact not only with our Scientific Advisory Board, but also advocacy groups and other allergy thought leaders.

您將看到我們在 2023 年繼續活躍在過敏社區。上個月，我們參加了美國過敏性哮喘和免疫學學會年會，更常見的是 ACAAI，正如之前披露的那樣，我們的科學顧問委員會成員提出了 4海報。這次會議讓我們有機會不僅與我們的科學顧問委員會互動，還與宣傳團體和其他過敏思想領袖互動。

We continue to hear the universal message about the significant unmet need for better products for the treatment of anaphylaxis. We also continue to hear that an oral product will likely be well received by the healthcare community and by patients. This year, we will continue to refine and understand the competitive positioning of AQST-109 as the non-injectable product landscape continues to progress.

我們繼續聽到關於對更好的過敏反應治療產品的重大未滿足需求的普遍信息。我們還繼續聽說一種口服產品可能會受到醫療保健界和患者的歡迎。今年，隨著非注射產品領域的不斷發展，我們將繼續完善和了解 AQST-109 的競爭定位。

Based on our interactions with the FDA we continue to believe AQST-109 profile as a distinct competitive advantage among non-injectable products under development. The literature is clear. The guideline for acute therapy and management of anaphylaxis states and "the symptoms of anaphylactic reaction usually begin acutely and may progress very quickly. Thus, symptoms can deteriorate within minutes".

基於我們與 FDA 的互動，我們仍然相信 AQST-109 的概況在開發中的非注射產品中具有獨特的競爭優勢。文獻很清楚。過敏反應的急性治療和管理指南指出，“過敏反應的症狀通常是急性開始的，並且可能進展得非常快。因此，症狀會在幾分鐘內惡化”。

A well-respected and published Scientific Advisory Board has also made it clear speed of absorption matters. And just as importantly, the FDA was clear with us stating and "similarity to epinephrine PK, via auto-injector is preferred". As you know, auto-injectors have shown a rapid uptake in plasma concentrations typically resulting in median Tmax between 10 and 20 minutes.

一個備受尊敬和出版的科學顧問委員會也明確了吸收問題的速度。同樣重要的是，FDA 對我們表示清楚，並且“首選通過自動注射器與腎上腺素藥代動力學相似”。如您所知，自動注射器已經顯示出血漿濃度的快速攝取，通常導致中位 Tmax 在 10 到 20 分鐘之間。

Based on the data from our 2 completed pharmacokinetic studies, AQST-109 Median Tmax of approximately 12 minutes is within this range. We believe that healthcare providers, caregivers and patients will also view rapid uptake as important.

根據我們 2 項已完成的藥代動力學研究的數據，大約 12 分鐘的 AQST-109 中值 Tmax 在此範圍內。我們相信，醫療保健提供者、護理人員和患者也會將快速吸收視為重要。

At the same time, we will continue to focus on growing our commercial collaborations and strengthening our balance sheet. Let's start with our commercial collaborations. We now have 7 significant out licensing collaborations that spanned 6 continents. Our collaboration with Hypera in South America has resulted in the launch of Ondif, ondansetron oral film in Brazil for the treatment of nausea. This launch is on track and we continue to see strong order growth.

與此同時，我們將繼續專注於發展我們的商業合作並加強我們的資產負債表。讓我們從我們的商業合作開始。我們現在擁有跨越 6 大洲的 7 項重要的許可合作。我們與南美洲的 Hypera 合作，在巴西推出了用於治療噁心的昂丹司瓊口腔膜劑 Ondif。此次發布進展順利，我們繼續看到強勁的訂單增長。

Our collaboration was Zambon in Europe has resulted in the approval of emylif, riluzole oral film for the treatment of ALS. Zambon plans on launching emylif in the coming months and we look forward to supporting their efforts. And finally, our collaboration with Pharmanovia in Europe remains on track as well and we look forward to bringing Libervant to patients and healthcare providers in Europe if approved.

我們在歐洲與 Zambon 的合作導致了 emylif、利魯唑口服膜劑用於治療 ALS 的批准。 Zambon 計劃在未來幾個月推出 emylif，我們期待支持他們的努力。最後，我們與 Pharmanovia 在歐洲的合作也仍在進行中，如果獲得批准，我們期待著將 Libervant 帶給歐洲的患者和醫療保健提供者。

We've also carried over our focus on raising non-dilutive capital from 2022 into 2023 and have already generated an additional $20 million in the first quarter of 2023. We recently reached agreement with Indivior on several outstanding matters, including reimbursement of costs due under our license and supply agreement, and changes to transfer pricing. This agreement resulted in a onetime cash payment of approximately $11.5 million.

我們還將我們的重點從 2022 年轉移到 2023 年，並且已經在 2023 年第一季度額外產生了 2000 萬美元。我們最近與 Indivior 就幾項未決事項達成了協議，包括償還根據我們的許可和供應協議，以及轉讓定價的變更。該協議導致一次性支付約 1150 萬美元的現金。

Indivior is important to the company and I'm pleased that we have agreed upon several contractual updates that in my mind strengthen the relationship between the two organizations. I'm also excited to say that we have reached a settlement with Biodelivery Sciences International related to our ongoing patent infringement case regarding Belbuca in Booneville. A settlement resulted in a onetime cash payment of $8.5 million to Aquestive. It is time to move on from this case and continue to resolve our outstanding litigation cases where appropriate.

Indivior 對公司很重要，我很高興我們已經就幾項合同更新達成一致，在我看來，這些更新加強了兩個組織之間的關係。我也很高興地說，我們已經與 Biodelivery Sciences International 就我們正在進行的關於布恩維爾 Belbuca 的專利侵權案達成和解。一項和解協議導致向 Aquestive 一次性支付 850 萬美元的現金。現在是時候從這個案件中繼續前進，並在適當的時候繼續解決我們未決的訴訟案件了。

In addition, we are pursuing potential collaborations in Europe and China for the rights to AQST-109. And for Libervant we are pursuing potential collaborations in multiple markets, including the US. While there is no guarantee of success, we will continue to pursue these opportunities.

此外，我們正在歐洲和中國尋求潛在的合作，以獲得 AQST-109 的權利。對於 Libervant，我們正在尋求在多個市場（包括美國）的潛在合作。雖然不能保證一定會成功，但我們將繼續尋求這些機會。

As a final point on this subject and as I stated before, we will remain disciplined on the out licensing process for Libervant. Especially as we learn more from the FDA. We believe Libervant remains an important product for those suffering from seizure clusters and the patients in the epileptic community will be better off with access to the product now, rather than waiting until 2027 when orphan drug exclusivity of a competitive product is scheduled to expire.

作為關於這個主題的最後一點，正如我之前所說，我們將在 Libervant 的許可程序上保持紀律。特別是當我們從 FDA 了解更多信息時。我們相信 Libervant 仍然是那些患有叢集性癲癇發作的患者的重要產品，癲癇患者現在就可以使用該產品，而不是等到 2027 年競爭產品的孤兒藥獨占期到期時，情況會更好。

The healthcare providers, advocacy groups and patients we have interacted with have given us the same feedback. We believe 2023 is another critical year for Libervant. As we've discussed before, we have provided the FDA with additional clinical data in our proposed protocol for a head-to-head study of Libervant against the products currently blocking our access to the US market. The FDA has assured us that and "The office of orphan products development and the review division are actively working on review of the newly submitted information and the proposed study. Although we cannot commit to a precise date for providing response, we're making all efforts to respond in a reasonable timeframe". While all of us are frustrated by the lack of speed of the responses, we will continue to diligently pursue us market access.

我們接觸過的醫療保健提供者、宣傳團體和患者都給了我們同樣的反饋。我們認為 2023 年對 Libervant 來說又是關鍵的一年。正如我們之前所討論的，我們已經在我們提議的協議中向 FDA 提供了額外的臨床數據，以針對目前阻礙我們進入美國市場的產品對 Libervant 進行頭對頭研究。 FDA 向我們保證，“孤兒產品開發辦公室和審查部門正在積極審查新提交的信息和擬議的研究。雖然我們不能承諾提供答复的確切日期，但我們正在盡一切努力努力在合理的時間範圍內做出反應”。雖然我們所有人都對反應速度不夠快感到沮喪，但我們將繼續努力爭取我們的市場准入。

We are taking several steps to continue the financial turnaround story of the company. In the first quarter of 2023 we expect to reduce our outstanding debt by 18%. And by the end of 2023 we further expect to reduce our overall debt by over 40%. Depending on market conditions, interest rates and terms we may seek to refinance our debt as the debt level becomes right sized for our business. Ernie we'll talk more about the financials in a moment.

我們正在採取幾個步驟來繼續公司的財務轉機故事。到 2023 年第一季度，我們預計我們的未償債務將減少 18%。到 2023 年底，我們進一步預計我們的整體債務將減少 40% 以上。根據市場狀況、利率和條款，當債務水平變得適合我們的業務時，我們可能會尋求為我們的債務再融資。厄尼，我們稍後會詳細討論財務狀況。

In conclusion, we carry our momentum from 2022 into 2023 and are off to a fast start. Our total non-dilutive capital raise is now over $45 million since May of last year. This year, you can expect us to focus on rapidly progressing AQST-109 into a pivotal study pursuant to the FDA's parameters, expanding our collaborations and out licensing arrangements, further strengthening our balance sheet and continuing to work towards us market access for Libervant.

總之，我們將保持 2022 年的勢頭到 2023 年，並開始快速發展。自去年 5 月以來，我們的非稀釋性資本籌集總額現已超過 4500 萬美元。今年，您可以期待我們根據 FDA 的參數將重點放在快速推進 AQST-109 成為一項關鍵研究，擴大我們的合作和許可安排，進一步加強我們的資產負債表，並繼續努力爭取 Libervant 的市場准入。

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

有了這個，我會把電話轉給厄尼。

Thank you, Dan, and good morning, everyone. By now, you have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the fourth quarter and full year 2022 results into Q&A.

謝謝丹，大家早上好。到目前為止，您已經在昨晚發布的收益報告中看到了我們的財務結果。正如我們通常所做的那樣，我們會將與第四季度和 2022 年全年業績相關的大部分討論納入問答環節。

During the fourth quarter of 2022 and continuing into 2023, we continue to manage the company for success as we received additional non-dilutive capital and reduced expenses going forward to extend our cash runway to support the continued development of our lead product, AQST-109, the first orally administered epinephrine product.

在 2022 年第四季度和持續到 2023 年，我們將繼續管理公司取得成功，因為我們獲得了額外的非稀釋性資本並減少了未來的支出以擴展我們的現金跑道以支持我們的主要產品 AQST-109 的持續開發，第一種口服腎上腺素產品。

During the fourth quarter, we entered into a license agreement with Otter Pharmaceuticals, a subsidiary of Assertio Holdings to license Sympazan. Under the terms of the license agreement, we granted an exclusive worldwide license of our intellectual property for Sympazan to Assertio for an upfront payment of $9 million and a $6 million milestone payment subsequent to the notice received from the U.S. Patent and Trademark Office of allowance of an additional patent application for Sympazan.

在第四季度，我們與 Assertio Holdings 的子公司 Otter Pharmaceuticals 簽訂了許可協議，以許可 Sympazan 。根據許可協議的條款，我們將我們的 Sympazan 知識產權的全球獨家許可授予 Assertio，預付款為 900 萬美元，在收到美國專利商標局的許可通知後，里程碑付款為 600 萬美元Sympazan 的額外專利申請。

In addition, we also entered into a long-term supply agreement with Assertio for Sympazan and will receive royalty payments from Assertio on Sympazan sales during the term of the license agreement. The $15 million received from the Assertio transaction, along with previously announced transactions with Haisco and Pharmanovia generated over $25 million of non-dilutive financing in 2022. These transactions, along with prudent expense management contributed to our year-end cash balance of $27.3 million.

此外，我們還與 Assertio 就 Sympazan 簽訂了長期供應協議，並將在許可協議期限內收到 Assertio 對 Sympazan 銷售的特許權使用費。從 Assertio 交易中收到的 1500 萬美元，以及之前宣布的與 Haisco 和 Pharmanovia 的交易，在 2022 年產生了超過 2500 萬美元的非稀釋性融資。這些交易以及審慎的費用管理使我們的年終現金餘額達到 2730 萬美元。

The recently announced amendment to the Indivior license and supply agreement as well as the legal settlement agreement with BDSI generated $20 million of non-dilutive capital that was received in March 2023. As we have previously stated, we will always pursue non-dilutive sources of capital first to extend our cash runway.

最近宣布的 Indivior 許可和供應協議修正案以及與 BDSI 的法律和解協議產生了 2023 年 3 月收到的 2000 萬美元非稀釋性資本。正如我們之前所說，我們將始終尋求非稀釋性來源資本優先，以擴大我們的現金跑道。

As Dan mentioned, we expect to reduce our overall debt by approximately 18% by the end of the first quarter of 2023 and by 40% by the end of 2023 through a combination of principal prepayments and scheduled principal payments. As previously announced, we prepaid approximately $6 million of principal to date during the first quarter of 2023. We would expect to refinance our remaining debt balance depending on market conditions.

正如 Dan 所提到的，我們預計到 2023 年第一季度末將我們的總債務減少約 18%，到 2023 年底通過本金預付和計劃本金支付的組合減少 40%。正如之前宣布的那樣，我們在 2023 年第一季度預付了迄今為止約 600 萬美元的本金。我們預計將根據市場情況為剩餘的債務餘額再融資。

Total revenues were $10.7 million in the fourth quarter of 2022 compared to $11.1 million in the fourth quarter of 2021, a decrease of 4%. For the fourth quarter of 2022 compared to the prior year period, we saw a 141% increase in license and royalty revenue due to an increase in our licensee sales of products. A 17% increase in co-development and research fees revenue and a 16% increase in manufacturing and supply revenue due to increased manufacturing volume of (inaudible) for Hypera in Brazil offset by a 79% decrease in proprietary sales net revenue due to the licensing of Sympazan to Assertio in October 2022.

2022 年第四季度的總收入為 1070 萬美元，與 2021 年第四季度的 1110 萬美元相比下降了 4%。與去年同期相比，2022 年第四季度，由於我們的被許可人產品銷量增加，我們的許可和特許權使用費收入增長了 141%。由於巴西 Hypera 的（聽不清）製造量增加，共同開發和研究費用收入增加了 17%，製造和供應收入增加了 16%，但由於許可，專有銷售淨收入減少了 79% 2022 年 10 月從 Sympazan 到 Assertio。

Total revenues were $47.7 million for the full year 2022 compared to $50.8 million for the full year 2021, a decrease of 6%. Excluding nonrecurring revenue of $4.1 million that was recognized in 2021, total revenue increased by 2%. Comparing the year ended 2022 to the prior period, we saw a 3% increase in manufacturer and supply revenue and a 10% decrease in proprietary sales due to the out-licensing of Sympazan.

2022 年全年的總收入為 4770 萬美元，而 2021 年全年的收入為 5080 萬美元，下降了 6%。不包括 2021 年確認的 410 萬美元的非經常性收入，總收入增長了 2%。與截至 2022 年的年度相比，由於 Sympazan 的對外許可，我們看到製造商和供應收入增長了 3%，專有銷售額下降了 10%。

Our net loss for the fourth quarter of 2022 was $12.4 million or $0.23 loss per share. Our net loss for the fourth quarter of 2021 was $28.9 million or $0.72 loss per share. The change in net loss was primarily driven by a onetime loss on extinguishment of debt of $13.8 million in 2021, lower noncash interest expense related to the KYNMOBI monetization transaction of $1.8 million and a decrease in total operational costs and expenses of $1.4 million, primarily due to a reduction in our sales force subsequent to the out licensing of Sympazan during the fourth quarter of 2022. And lower share-based compensation expense, offset by higher raw material and production costs.

我們 2022 年第四季度的淨虧損為 1240 萬美元或每股虧損 0.23 美元。我們 2021 年第四季度的淨虧損為 2890 萬美元或每股虧損 0.72 美元。淨虧損的變化主要是由於 2021 年債務清償的一次性虧損 1380 萬美元、與 KYNMOBI 貨幣化交易相關的非現金利息支出減少 180 萬美元以及總運營成本和支出減少 140 萬美元，這主要是由於在 2022 年第四季度獲得 Sympazan 許可後我們的銷售人員減少。以及較低的基於股份的補償費用，被較高的原材料和生產成本所抵消。

Our net loss for the full year 2022 was $54.4 million or $1.12 loss per share. The net loss for the full year 2021 was $70.5 million or $1.85 loss per share. The change in net loss was primarily driven by a onetime loss on the extinguishment of debt of $13.8 million in 2021, lower noncash interest expense related to the KYNMOBI monetization transaction of $6.5 million and lower interest expense of $3.5 million, offset by higher costs and expenses of $4.2 million, including onetime severance expenses.

我們 2022 年全年的淨虧損為 5440 萬美元或每股虧損 1.12 美元。 2021 年全年的淨虧損為 7050 萬美元或每股虧損 1.85 美元。淨虧損的變化主要是由於 2021 年債務清償的一次性虧損 1,380 萬美元、與 KYNMOBI 貨幣化交易相關的非現金利息支出減少 650 萬美元以及利息支出減少 350 萬美元，但被更高的成本和支出所抵消420 萬美元，包括一次性遣散費。

Non-GAAP adjusted EBITDA loss was $9.6 million in the fourth quarter of 2022 compared to a $9.2 million loss in the fourth quarter of 2021. Non-GAAP adjusted EBITDA loss was $35.3 million in the full year 2022 compared to $24.9 million in the full year 2021. The year-over-year change in non-GAAP adjusted EBITDA loss was primarily driven by the items described above.

2022 年第四季度非美國通用會計準則調整後 EBITDA 虧損為 960 萬美元，而 2021 年第四季度為虧損 920 萬美元。2022 年全年非美國通用會計準則調整後 EBITDA 虧損為 3530 萬美元，而全年為 2490 萬美元2021 年非 GAAP 調整後 EBITDA 損失的同比變化主要是由上述項目驅動的。

As of December 31, 2022, cash and cash equivalents were $27.3 million. Under the At-The-Market or ATM facility, we accessed $860,000 of new proceeds during the fourth quarter of 2022 and $3.9 million during the year ended December 31, 2022. The ATM facility has approximately $33.4 million available at December 31, 2022.

截至 2022 年 12 月 31 日，現金及現金等價物為 2730 萬美元。在市場或 ATM 設施下，我們在 2022 年第四季度獲得了 860,000 美元的新收益，在截至 2022 年 12 月 31 日的年度中獲得了 390 萬美元。ATM 設施在 2022 年 12 月 31 日有大約 3340 萬美元可用。

We are focused in 2023 on the continued development of our epinephrine program and commencing our pivotal PK program later in the year. Suboxone continues to retain a strong presence in both the U.S. commercial and CMS markets and continues to provide an opportunity outside the U.S. While Suboxone is a legacy product for us, it remains a significant part of our near-term revenue outlook. This product continued to perform well in 2022 with Indivior retaining a U.S. market share of approximately 34%.

我們在 2023 年專注於繼續開發我們的腎上腺素計劃，並在今年晚些時候開始我們的關鍵 PK 計劃。 Suboxone 繼續在美國商業和 CMS 市場保持強大的影響力，並繼續在美國以外提供機會。雖然 Suboxone 是我們的傳統產品，但它仍然是我們近期收入前景的重要組成部分。該產品在 2022 年繼續表現良好，Indivior 保持了約 34% 的美國市場份額。

Our revenue guidance for 2023 considers a modest level of market share erosion. Moreover, in 2023, we will continue to focus on capital conservation so that our cash runway is extended as far as possible. As outlined in the press release issued last night after market closed, we provided our full year 2023 financial guidance as follows: Total revenues of approximately $37 million to $41 million and non-GAAP adjusted EBITDA loss of approximately $31 million to $36 million.

我們對 2023 年的收入指引考慮了適度的市場份額侵蝕。此外，在 2023 年，我們將繼續專注於資本保護，以盡可能延長我們的現金跑道。正如昨晚收市後發布的新聞稿所述，我們提供了 2023 年全年財務指導如下：總收入約為 3700 萬至 4100 萬美元，非公認會計準則調整後的 EBITDA 虧損約為 3100 萬至 3600 萬美元。

Please note, our revenue guidance for 2023 no longer includes proprietary net sales for Sympazan due to the license agreement with Assertio, but does include manufacturing and supply revenue and royalty fees. In addition, our guidance for 2023 includes focused R&D investments related to the continued development of AQST-109, again the first orally administered epinephrine product.

請注意，由於與 Assertio 的許可協議，我們的 2023 年收入指南不再包括 Sympazan 的專有淨銷售額，但包括製造和供應收入以及特許權使用費。此外，我們對 2023 年的指導包括與 AQST-109 的持續開發相關的重點研發投資，這也是第一個口服腎上腺素產品。

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

有了這個，我現在將線路轉回接線員以打開問題線路。

(Operator Instructions) Our first question comes from Gary Nachman with BMO.

（操作員說明）我們的第一個問題來自 BMO 的 Gary Nachman。

This is Dennis on for Gary. Regarding 109, can you just talk a little bit more about the March FDA interaction? What information do they provide? Was this proactive on their part? Do they provide any specific suggestions as to what would and would not be a good competitive product? And did they provide any new additional color to what they would be important to show in the pivotal trial? I've got one follow-up after.

這是丹尼斯替加里。關於 109，你能多談談 3 月份與 FDA 的互動嗎？他們提供什麼信息？這是他們主動的嗎？他們是否就什麼會是什麼不是好的競爭產品提供任何具體建議？他們是否為他們在關鍵試驗中重要展示的內容提供了任何新的附加顏色？之後我有一個跟進。

Thanks for the question on 109. I'm going to pass that over to our SVP of R&D, Steve Wargacki to give you an answer.

感謝您在 109 上提出問題。我將把這個問題轉交給我們的研發高級副總裁 Steve Wargacki 來給您答复。

Thanks, Dan. And thank you, Dennis. The interaction that we had in March was initiated by us, and it was designed to gain clarity. A lot of topics were covered at the end of Phase II meeting. And we sought to gain clarity exactly what would be required to get the proper feedback on our pivotal protocol. And we got that clarification from the RLD selections at our choice. And as Dan mentioned in his comments, will be informed by the study we have currently ongoing.

謝謝，丹。謝謝你，丹尼斯。我們在 3 月份進行的互動是由我們發起的，旨在獲得清晰度。第二階段會議結束時討論了很多主題。我們試圖弄清楚究竟需要什麼才能獲得關於我們關鍵協議的適當反饋。我們從我們選擇的 RLD 選擇中得到了澄清。正如 Dan 在他的評論中提到的那樣，我們目前正在進行的研究將為您提供信息。

And Dennis, in terms of the selection of the reference listed products that is completely up to us as the sponsor to choose the FDA has given us clear guidance, but it is our choice.

而丹尼斯，在參考上市產品的選擇方面完全取決於我們作為贊助商選擇 FDA 給了我們明確的指導，但這是我們的選擇。

Okay. Perfect. And then regarding the recent presentation of the allergy asthma and immunology meeting last month, can you just maybe talk about the receptivity the posters got and overall KOL physician feedback?

好的。完美的。然後關於上個月過敏性哮喘和免疫學會議的最新報告，你能談談海報的接受度和 KOL 醫生的整體反饋嗎？

Sure. I'm going to pass that over to our Chief Commercial Officer, Ken Marshall.

當然。我要把它轉交給我們的首席商務官 Ken Marshall。

Dan, can you guys hear me okay? Yes, it was a good meeting for Aquestive. We had 4 posters. We had KOLs presenting on our behalf at each one of those along with Aquestive support and showed a range of data. I had talked about our rapid Tmax. I think that was one of the highlights in one of the most impressive pieces of data to the audience.

丹，你們能聽到我說話嗎？是的，這對 Aquestive 來說是一次很好的會議。我們有 4 張海報。我們讓 KOL 代表我們出席了每一個活動，並提供了 Aquestive 的支持，並展示了一系列數據。我談到了我們的快速 Tmax。我認為這是給觀眾留下最深刻印象的數據之一中的亮點之一。

We've consistently produced a 12-minute TMAX and that's unlike any other medicine, especially in oral medicine. And that was the other takeaway, how frustrated the medical community is and the patient community that was in attendance with the needle devices. They certainly are looking for a better solution and extremely impressed with our ability to put epinephrine on a scrip and deliver it orally.

我們一直生產 12 分鐘的 TMAX，這不同於任何其他藥物，尤其是口服藥物。這是另一個要點，醫學界和使用針頭設備的患者社區是多麼沮喪。他們當然正在尋找更好的解決方案，並且對我們將腎上腺素放在紙條上並口服給藥的能力印象深刻。

Denis just to add on, comments gives us really excited about AQST-109. It continues to get as excited as we're the only oral product in development. We know there's a variety of nasal sprays that are coming through, but we're not aware of any significant other oral product that is in development at this time. So we think that's a really important and unique position for our product.

丹尼斯補充說，評論讓我們對 AQST-109 感到非常興奮。它繼續像我們是唯一開發中的口服產品一樣令人興奮。我們知道有各種各樣的鼻腔噴霧劑正在上市，但我們不知道目前正在開發任何其他重要的口服產品。所以我們認為這對我們的產品來說是一個非常重要和獨特的位置。

Our next question comes from Jason Butler with JMP Securities.

我們的下一個問題來自 JMP Securities 的 Jason Butler。

It's Roy on for Jason. I had a couple of follow-ups on 109 and then one for Ernie. So I guess on 109, again, on the protocol, I know you're going to submit to the agency in your pending list this reference product data. But just any details you can give us about the proposed final design at this time? And then, Dan, you made a comment about better characterizing the market in 2023 as it evolves. Just any details you can give us on the efforts that you're going to make and the key questions you're looking to answer?

羅伊代替傑森。我對 109 進行了幾次跟進，然後對 Ernie 進行了一次跟進。所以我想在 109 上，再一次，在協議上，我知道你將向你的待定列表中的機構提交這個參考產品數據。但是您現在可以向我們提供有關擬議最終設計的任何詳細信息嗎？然後，丹，你發表了關於在 2023 年隨著市場的發展更好地描述市場特徵的評論。關於您將要做出的努力以及您希望回答的關鍵問題，您可以向我們提供任何詳細信息嗎？

Sure. Roy, I'll take the market evolution question. Let me do that first, and then I'll hand it over to Steve to talk about the protocol design. I think you've heard Ken talk before about our -- what we've noticed in the seizure cluster market, which as alternate products have come into the market, the market expands considerably. In that case, I think it is just about doubled.

當然。羅伊，我來回答市場演變問題。讓我先做，然後我會把它交給史蒂夫來談談協議設計。我想你之前聽過 Ken 談論過我們——我們在緝獲集群市場上註意到的，隨著替代產品進入市場，市場大幅擴大。在那種情況下，我認為它只是翻了一番。

So in our view, as alternate non-injection products come into the treatment of allergic -- severe allergic reaction space, we believe the market will expand, and we want to make sure we keep an eye on how those dynamics unfold as other products come through the system. But again, as we look at how patients think about treating anaphylaxis, we continue to believe that oral is generally a preferred method, and we look forward to having that offering in the market.

因此，在我們看來，隨著替代非注射產品進入治療過敏——嚴重過敏反應領域，我們相信市場將會擴大，我們希望確保我們密切關注這些動態如何隨著其他產品的出現而展開通過系統。但同樣，當我們觀察患者如何看待治療過敏反應時，我們仍然認為口服通常是首選方法，我們期待在市場上提供這種產品。

With that, I'll turn the second question you had on the protocol design over to Steve.

有了這個，我將把你關於協議設計的第二個問題轉交給史蒂夫。

Yes. And, so the pivotal protocol design remains consistent with what we've previously guided. We anticipate this being an 80 to 100 healthy volunteer subject study, looking at the pharmacokinetics and pharmacodynamics of our product against 2 or more reference products, and that will allow us to demonstrate how we perform relative to the products that are available on the market.

是的。而且，關鍵協議設計與我們之前的指導保持一致。我們預計這是一項 80 到 100 名健康志願者的受試者研究，研究我們的產品針對 2 種或更多參考產品的藥代動力學和藥效學，這將使我們能夠展示我們相對於市場上可用產品的表現。

Okay. Great. That's helpful. And then one for Ernie. Just any details on the expense trajectory for 2023. That seems like we should expect SG&A maybe to continue down this quarter. Just anything you can give us there?

好的。偉大的。這很有幫助。然後一個給厄尼。關於 2023 年支出軌蹟的任何細節。我們似乎應該預計 SG&A 可能會在本季度繼續下降。你能給我們什麼嗎？

Well, as I said in my script, we're continuing to manage our expenses closely to help with our cash runway. Certainly, the reduction, as I announced in my script about the reduction in expenses last year related to the out-license of Sympazan to Assertio will carry forward into 2023 and is embedded in our projections. I think the important thing about our expenses for 2023 is the continued focus on the advancement of our 109 project.

好吧，正如我在腳本中所說，我們將繼續密切管理我們的開支，以幫助我們的現金跑道。當然，正如我在我的劇本中宣布的那樣，去年與將 Sympazan 授權給 Assertio 相關的費用減少將延續到 2023 年，並包含在我們的預測中。我認為我們 2023 年的開支最重要的是繼續關注我們 109 項目的推進。

Okay. Great. Let me throw in one more on 109. Just on the European and Chinese partnership discussions, you can never predict when those are going to happen, but are you kind of waiting for the data or is it possible to finalize one of those before you get the pivotal data?

好的。偉大的。讓我在 109 上再投入一個。就歐洲和中國的伙伴關係討論而言，你永遠無法預測這些何時會發生，但你是在等待數據還是有可能在你得到之前完成其中之一關鍵數據？

Well, I think as you know, the business development in any company is a constant part of the business. So, at this time, we will continue to look at the potential opportunities that are there. I think as we go, of course, and more data is available on 109, those opportunities will evolve. But I think you'll see us continue to look for the right partnerships to make sure that we can broadly distribute 109, not just in Europe and China, but quite frankly, all over the globe. So that's one of the themes of our company as we go through 2023, is making sure our products are available in a variety of markets and 109 is, of course, one of those products that will be focused on making sure we place correctly.

好吧，我認為如您所知，任何公司的業務發展都是業務的一個不變部分。因此，在這個時候，我們將繼續關注那裡的潛在機會。我認為，當然，隨著 109 的更多數據可用，這些機會將會不斷發展。但我想你會看到我們繼續尋找合適的合作夥伴關係，以確保我們能夠廣泛分發 109，不僅在歐洲和中國，而且坦率地說，在全球範圍內。因此，這是我們公司到 2023 年的主題之一，即確保我們的產品在各種市場上都有售，而 109 當然是將專注於確保我們正確放置的產品之一。

Our next question comes from Francois Brisebois with Oppenheimer.

我們的下一個問題來自 Francois Brisebois 和 Oppenheimer。

Just a couple here. I was just wondering if you think maybe compare and contrast this bracketed kind of method of showing your PK data to the FDA which reference products. And you seem to say the reference products that you end up using are your choice. Can you just maybe compare and contrast what the process has been for the nasal spray? And I think we're expecting a PDUFA midyear here. So just the bracket approach, did they have to use 2 or more similar products? Do they have a choice on what products to use? I'm just trying to figure out if the FDA has been consistent with both companies here.

這裡只有一對。我只是想知道您是否認為可以比較和對比這種將您的 PK 數據顯示給 FDA 的參考產品的方括號方法。你似乎說你最終使用的參考產品是你的選擇。您能否比較和對比噴鼻劑的過程？我想我們期待這裡的 PDUFA 年中。那麼只是支架方法，他們是否必須使用 2 種或更多類似產品？他們可以選擇使用什麼產品嗎？我只是想弄清楚 FDA 是否與這裡的兩家公司保持一致。

Yes. Frank, thanks for the question. From -- so obviously, we -- as you know, we don't know exactly what the FDA is saying to the other applicants. So we have the same public information that you have. But our view from looking at the public statements of the nasal sprays that are in development is -- and also our experience with the FDA in other drug development places is that they are being consistent with the various products. So my opinion would be that marketing is something that all products that are seeking this indication will have to achieve.

是的。弗蘭克，謝謝你的提問。從——很明顯，我們——正如你所知，我們並不確切知道 FDA 對其他申請人說了什麼。因此，我們擁有與您相同的公共信息。但是我們從正在開發的鼻腔噴霧劑的公開聲明來看我們的觀點是——以及我們在其他藥物開發場所與 FDA 的經驗是它們與各種產品是一致的。所以我的觀點是，營銷是所有尋求該適應症的產品都必須實現的目標。

I think the real question for the FDA will be on the speed side, how fast do you have to be in order to be relevant for this particular indication.

我認為 FDA 真正的問題是速度方面，你必須多快才能與這個特定的適應症相關。

Understood. And as the median that you guided to with the FDA in the second half of '23 for the administration part, of the label. So is there a chance -- I guess that means that you could start the pivotal in the third quarter and then potentially have this meeting about administration in the fourth quarter. It wouldn't be a barrier to maybe starting or absolutely starting the pivotal?

明白了。作為你在 23 年下半年為標籤的管理部分指導 FDA 的中位數。那麼有沒有機會——我想這意味著你可以在第三季度開始關鍵，然後可能在第四季度召開關於管理的會議。這不會成為開始或絕對開始關鍵時刻的障礙嗎？

No, no. Just to -- that's a great question. Just to clarify, as we outlined in December, we had a very productive End-of-Phase II meeting that Steve and his team led. And we learned or we feel we have learned a clear set of things that the FDA wants to see in our filing. Obviously, one is the pivotal study. But the other is related to administration as we outlined. And so Steve and the team have, very smartly in my view, worked with the FDA to clarify that we can separate those 2 things into 2 different activities with the FDA that then come together with at the filing. So I think that was a smart development move, and it allows us to pivotal while also having that meaning on the administration items with the FDA.

不，不。只是——這是一個很好的問題。澄清一下，正如我們在 12 月概述的那樣，我們在史蒂夫和他的團隊領導下召開了一次非常富有成效的第二階段結束會議。我們了解到或者我們覺得我們已經了解了 FDA 希望在我們的備案中看到的一系列明確的事情。顯然，一個是關鍵研究。但另一個與我們概述的管理有關。因此，在我看來，史蒂夫和他的團隊非常聰明地與 FDA 合作，以澄清我們可以將這兩件事分成與 FDA 的兩項不同活動，然後在備案時結合在一起。所以我認為這是一個明智的發展舉措，它使我們能夠發揮關鍵作用，同時也對 FDA 的管理項目具有這種意義。

Our next question comes from Thomas Flaten with Lake Street.

我們的下一個問題來自 Thomas Flaten 和 Lake Street。

Just to follow up on the last question, Dan. So there's no risk that there would be a learning or a finding from the administration characterization that would, in any way, impact FDA's thinking around the pivotal, right? I just want to confirm that.

只是跟進最後一個問題，Dan。因此，從管理特徵中學習或發現不會以任何方式影響 FDA 圍繞關鍵點的思考的風險是沒有的，對吧？我只是想確認一下。

Yes. I think the way to think about it is we -- look, we've been around for, I don't know, the better part of 20 years as a company. And our technology has always been oral thin film. So when we get questions around the administration elements of our technology, we have a big body of data that we can work from and a deep understanding. So I think we understand completely, at least based on what the comments have been to the FDA -- from the FDA so far, what they're looking for, and we're prepared to provide those -- that information. So right now, we don't see a reason to -- to have want, make it a linear process, we think, answering the administration pieces in one say, while the pivotal is going on is just fine.

是的。我認為思考它的方式是我們 - 看，我們已經存在了，我不知道，作為一家公司 20 年的大部分時間。而我們的技術一直都是口腔薄膜。因此，當我們對我們技術的管理元素提出疑問時，我們有大量數據可供我們使用並有深刻的理解。所以我認為我們完全理解，至少基於對 FDA 的評論 - 從 FDA 到目前為止，他們正在尋找什麼，我們準備提供這些 - 這些信息。所以現在，我們看不出有什麼理由 - 想要，讓它成為一個線性過程，我們認為，在一個關鍵的過程中回答管理問題就可以了。

And recognizing that a lot of the market characterization work is upcoming in the current year. I was curious if there's any obvious areas where an oral film would not be the preferable route of administration that you've been able to identify or feedback you've gotten from KOLs or patient groups?

並認識到今年將開展大量市場特徵描述工作。我很好奇是否有任何明顯的區域表明口腔膜片不是您能夠識別的或從 KOL 或患者群體那裡獲得的反饋的首選給藥途徑？

Sure. So Thomas, it's a tough question to ask a CEO on the earnings call, right? I'm obviously very biased towards our technology. I think our technology works broadly in the patient population, and that's why we're pursuing this product. We think that the fact that a majority of patients don't have a product at all with them during an allergic reaction, speaks volumes to the need for something that's easier to carry and simple to use, and we think we fit both of those criteria.

當然。所以托馬斯，在財報電話會議上問 CEO 是一個棘手的問題，對吧？我顯然非常偏向於我們的技術。我認為我們的技術廣泛適用於患者群體，這就是我們追求該產品的原因。我們認為大多數患者在過敏反應期間根本沒有產品這一事實充分說明了對更易於攜帶和使用簡單的產品的需求，我們認為我們符合這兩個標準.

So look, are there instances where other technologies might be preferred? Sure. But we're very focused on where our technology is it a benefit to patients. And we think in this area, we have a really strong and compelling value proposition to the patient.

那麼看看，是否存在其他技術可能更受歡迎的實例？當然。但我們非常關注我們的技術對患者有益的地方。我們認為在這個領域，我們對患者有一個非常強大和令人信服的價值主張。

Okay. And then just a final one for Ernie. The drop in gross margin or non-GAAP gross margin, in particular, Ernie, from third quarter to fourth quarter was pretty strong. Anything you could share with us with respect to that going into 2023?

好的。然後是給厄尼的最後一個。從第三季度到第四季度，毛利率或非 GAAP 毛利率的下降非常強勁，尤其是厄尼。關於進入 2023 年，您有什麼可以與我們分享的嗎？

Well, Thomas, I think there's a number of things that play there. It's a change in product mix, certainly removing high-margin products such as Sympazan that we're selling is important. When you compare year-over-year, the fact that, again, because the gross margin is on total revenue, the fact that there was incremental nonrecurring revenue last year of $4 million impacts high on the margin. And then when we factor in, again, related to Sympazan, the manufacturing revenue, which is at a different margin basis, the manufacturing the product and then taking into account the new product launches for Hypera, Brazil that's at a different margin. So it's really a change in product mix, along with just some incremental higher expenses related to materials in production.

好吧，托馬斯，我認為那裡有很多東西在起作用。這是產品組合的變化，當然刪除我們銷售的 Sympazan 等高利潤產品很重要。當你與去年同期比較時，事實上，由於毛利率是總收入的一部分，去年有 400 萬美元的非經常性收入增加對利潤率產生了很高的影響。然後，當我們再次考慮與 Sympazan 相關的因素時，製造收入以不同的利潤率為基礎，製造產品，然後考慮巴西 Hypera 的新產品發布，這是不同的利潤率。因此，這實際上是產品組合的變化，以及與生產材料相關的一些增量費用。

Our next question comes from Ram Selvaraju with H.C. Wainwright.

我們的下一個問題來自 Ram Selvaraju 和 H.C.溫賴特。

Just a few here. Dan, I was wondering if you could provide us with a little bit more color on the relationship with Indivior as it currently stands? And what additional advances or progress you expect over the course of 2023 and how you expect that to specifically, positively impact Aquestive's business? Secondly, I thought that you could perhaps offer us some additional detail on your updated thinking regarding AQST-108. And then lastly, with respect to Libervant, I was wondering if you could give us a sense of how you are thinking about the best possible path forward commercially for the drug in the United States and how that's being colored by the specific timing with which the product may receive market authorization.

這裡只有幾個。 Dan，我想知道你是否可以為我們提供更多關於目前與 Indivior 的關係的顏色？您期望在 2023 年期間取得哪些額外的進步或進步，以及您期望這將如何具體地、積極地影響 Aquestive 的業務？其次，我認為您或許可以向我們提供一些關於您對 AQST-108 的最新想法的更多詳細信息。最後，關於 Libervant，我想知道您是否可以讓我們了解您是如何考慮該藥物在美國商業化的最佳可能途徑，以及它是如何被具體時間點所影響的產品可能獲得上市許可。

Sure. Thanks, Ram. First, to start with your first question on our relationship with Indivior. I don't think there's any other way to characterize our relationship with Indivior other than it's a very important one. We value the relationship with them, and we're -- we continue to work with them to make sure that we are always providing high-quality products to their patients, and I think they appreciate that.

當然。謝謝，拉姆。首先，從您關於我們與 Indivior 的關係的第一個問題開始。我認為除了非常重要之外，沒有任何其他方式可以描述我們與 Indivior 的關係。我們重視與他們的關係，我們——我們將繼續與他們合作，以確保我們始終為他們的患者提供高質量的產品，我認為他們對此表示讚賞。

In terms of the amendment and agreement we just announced. I think that was a really positive step forward for our company. One, it showed the continued view on both sides as the relationship is important because one of the things that was extended is the term of the contract, which we were very happy to see. And two, I think there's a recognition that what we do for Indivior is important. And so in terms of making sure that the components of value that we receive from Indivior are with where they should be. I think we found a partner who is a relationship that is looking to work with us. So very excited about where that relationship is.

關於我們剛剛宣布的修正案和協議。我認為這對我們公司來說是向前邁出的非常積極的一步。第一，它顯示了雙方的持續觀點，因為這種關係很重要，因為延長的事情之一是合同期限，我們很高興看到這一點。第二，我認為人們認識到我們為 Indivior 所做的事情很重要。因此，就確保我們從 Indivior 獲得的價值組成部分而言，它們處於應有的位置。我認為我們找到了一個希望與我們合作的合作夥伴。對這種關係在哪裡感到非常興奮。

In terms of where it progresses from here. Look, there is generic competition of Suboxone. We recognize that. We know that over time, the volumes or the market share in the U.S. will slowly decline as outlined buying Indivior. And we'll continue to look to see how the overall volume offsets versus the market decline. While we don't control that. I think that's something we continue to watch carefully.

就從這裡開始的進展而言。看，有 Suboxone 的仿製藥競爭。我們認識到這一點。我們知道，隨著時間的推移，美國的銷量或市場份額將如收購 Indivior 所述緩慢下降。我們將繼續關注整體銷量如何抵消市場下滑。雖然我們無法控制。我認為這是我們繼續仔細觀察的事情。

In terms of 108, as I always say when we're asked on AQST-108, we love this product. We think this is a great opportunity to develop yet another product out of the epinephrine pro-drug platform. The reality right now is we're very focused on making sure in this macro environment that is very tough that we have a reasonable balance sheet. So the reality for us right now, as Ernie laid out, is that we will have -- I think the right word is disciplined on how we spend our money.

就 108 而言，當我們被問及 AQST-108 時，我總是說，我們喜歡這個產品。我們認為這是從腎上腺素前藥平台開發另一種產品的絕佳機會。現在的現實是，我們非常專注於確保在這個非常艱難的宏觀環境中我們有一個合理的資產負債表。因此，正如厄尼所說，我們現在的現實是——我認為正確的詞是對我們如何花錢進行紀律處分。

And so one way it's going to have to wait. It's going to wait until 109 is farther along. And until we have our balance sheet in a place where we feel very-very positive about our ability to do more pipeline programs.

因此，一種方式將不得不等待。它要等到109走得更遠。直到我們的資產負債表處於我們對我們執行更多管道計劃的能力感到非常非常積極的地方。

And then on Libervant, look, I think the thing that sometimes it's easy to forget on Libervant is that there are patients who will benefit from this product and they're waiting for the product. So putting even the desire of the company to get the product into the market side, we believe patients deserve this product. So we're going to continue to advocate, push, create data, make sure we are front and center with the FDA, make sure they understand the choice that they're making in blocking our product right now based on the needs of patients in the marketplace.

然後在 Libervant 上，看，我認為有時在 Libervant 上很容易忘記的是，有些患者將從該產品中受益，他們正在等待該產品。因此，即使公司希望將產品推向市場，我們也相信患者應該得到這種產品。因此，我們將繼續倡導、推動、創建數據，確保我們站在 FDA 的前沿和中心，確保他們了解他們現在根據患者的需求在阻止我們的產品方面做出的選擇市場。

So we're in no way are we going to step back from bringing that product to the market. When does it ultimately come to the market, we'll see, right? But in the meantime, we're very excited to be able to continue to expand our relationships and partnerships outside of the U.S., and we believe it will be in the hands of patients in Europe and other markets well before 2027.

因此，我們絕不會放棄將該產品推向市場。它最終什麼時候上市，我們拭目以待，對吧？但與此同時，我們很高興能夠繼續擴大我們在美國以外的關係和合作夥伴關係，我們相信它會在 2027 年之前交到歐洲和其他市場的患者手中。

Okay. And just one more question for Ernie. I was just wondering if you could clarify whether the financial guidance you've given for 2023 includes the impact of additional litigation settlements or not?

好的。還有一個問題要問厄尼。我只是想知道您是否可以澄清您為 2023 年提供的財務指導是否包括額外訴訟和解的影響？

Rob, no it does not take into account any impact for additional litigation settlements at this point.

Rob，不，它目前沒有考慮額外訴訟和解的任何影響。

Our next question comes from James Molloy with Alliance Global Partners.

我們的下一個問題來自 Alliance Global Partners 的 James Molloy。

Remarkable job on the non-dilutive cash in the early part of the year here. Just a quick follow-up on the additional settlements actually. Is there anything in 2023 (inaudible), we should be potentially anticipating as we look forward? And then a follow-up on that on Libervant. How would you characterize any potential partnership discussions? Is it really -- is there really a path forward on a partnership in advance of required in the FDA? Or is it always going to wait on that.

今年年初在非攤薄現金方面的出色工作。實際上只是對額外定居點的快速跟進。 2023 年有什麼（聽不清），我們應該在期待時潛在地期待嗎？然後是關於 Libervant 的跟進。您如何描述任何潛在的合作夥伴關係討論？是否真的 - 是否真的有在 FDA 要求之前建立夥伴關係的前進道路？或者它總是會等待那個。

Could you repeat the first question? There was a ding that occurred right in the middle of you speaking. We didn't quite catch that first question.

你能重複第一個問題嗎？在你說話的中間有一個叮噹聲。我們沒有完全理解第一個問題。

Sure. Just a follow-up on the prior question on any additional settlements. Is there anything that we should potentially anticipate over 2023, even if it's not in the guidance?

當然。只是對先前關於任何額外和解的問題的跟進。在 2023 年有什麼我們應該潛在預期的，即使它不在指南中？

Sure. So look, on the legal side, on the litigation side, I'm very pleased with how our company and our General Counsel in particular, has worked to reduce our legal spend over the last several months. First, we were able to have a motion to dismiss granted in the Suboxone antitrust case. Now we have successfully reached a settlement with BDSI on a long outstanding litigation case that was costing us money. So both of those items are a positive news for us and reduce our legal spend going forward.

當然。因此，在法律方面，在訴訟方面，我對我們公司，尤其是我們的總法律顧問在過去幾個月中如何努力減少我們的法律支出感到非常滿意。首先，我們能夠在 Suboxone 反托拉斯案中獲得駁回動議。現在，我們已經成功地與 BDSI 就一項耗費我們金錢的長期懸而未決的訴訟案件達成和解。因此，這兩項對我們來說都是好消息，並減少了我們未來的法律支出。

Will there be other settlements this year? Look, we don't have much left in terms of litigation inside of this company. So I don't know if I see big things on the horizon for that area, but I suppose you never know.

今年還會有其他定居點嗎？看，我們在這家公司內部的訴訟方面所剩無幾。所以我不知道我是否會在該地區的地平線上看到大事，但我想你永遠不會知道。

In terms of Libervant potential partnerships. Yes, we do believe that there are potential partnerships to be had with Libervant, both outside the U.S. and in the U.S. I think the critical thing for Ernie, myself and the team is the discipline around what is the right partnership. And what does the value look like, what does the pathway look like and how do we make sure that patients are maximized in that partnership. So that's where I think you'll see us just be really thoughtful. But yes, if all we wanted to do was find a partner, I don't think that's the difficult part of finding the right one, that's a difficult part.

在 Libervant 潛在的合作夥伴關係方面。是的，我們確實相信與 Libervant 有潛在的合作夥伴關係，無論是在美國以外還是在美國。我認為對 Ernie、我自己和團隊來說，關鍵是圍繞什麼是正確的合作夥伴關係的紀律。價值是什麼樣的，途徑是什麼樣的，我們如何確保患者在這種夥伴關係中最大化。所以這就是我認為你會看到我們真的很周到的地方。但是，是的，如果我們只想找到一個合作夥伴，我不認為這是找到合適的合作夥伴的困難部分，這是一個困難的部分。

And would you be able to characterize sort of how many of the right partners have come in and you still -- you trying to judge between them? Or is it really -- again, it lots going to depend on if you can actually get approved by the FDA, certainly a big issue for.

你能描述一下有多少合適的合作夥伴進來了，而你仍然——你試圖在他們之間做出判斷嗎？還是真的——再一次，這在很大程度上取決於你是否真的能得到 FDA 的批准，這當然是一個大問題。

Sure. I think the right way to characterize it is we have a lot of active discussions. So whether those are the right partners or there's more right partners to come, I think, it's kind of an amorphous thing for us to know, but I think we have a reasonable set of potential collaborations that could occur.

當然。我認為描述它的正確方法是我們進行了很多積極的討論。因此，無論這些是合適的合作夥伴還是有更多合適的合作夥伴來，我認為，這對我們來說是一種不確定的事情，但我認為我們有一套合理的潛在合作可能發生。

(Operator Instructions) Our next question comes from Andreas Agora with Wedbush.

（操作員說明）我們的下一個問題來自 Andreas Agora 和 Wedbush。

This is Caroline on for Andreas. So I just have one question on 109. In the press release, it was mentioned that you continue to characterize the administration of 109 under potential conditions of allergic reactions. Just wondering if you can elaborate on the conditions, you are evaluating 109 under, and if this was requested specifically by the FDA during the End-of-Phase II meeting or in their March correspondence?

這是安德烈亞斯的卡羅琳。所以我只有一個關於 109 的問題。在新聞稿中，有人提到你繼續描述 109 在潛在過敏反應條件下的給藥特徵。只是想知道您是否可以詳細說明您正在評估 109 的條件，以及這是否是 FDA 在第二階段結束會議期間或在他們 3 月份的信函中特別要求的？

And then what else might the FDA want to see besides the altered dosing conditions evaluated in Part 3 of the PFAS study?

那麼，除了 PFAS 研究第 3 部分中評估的改變劑量條件之外，FDA 還希望看到什麼？

Sure. Thanks, Caroline. I'll pass that over to Steve.

當然。謝謝，卡羅琳。我會把它轉交給史蒂夫。

Yes. And so in End-of-Phase II meeting, we discussed with the FDA a variety of topics, some of them we're ensuring the ability to administer and deliver our product under the conditions of a severe allergic reaction, which is expected and certainly a conversation we look forward to. And we do continue to evaluate all of those conditions that ultimately is all tied to your risk benefit in your NDA, and that's part of that meeting that we talked about having later in the year with the agency is to present all of our work on it line that we've characterized everything in the right way and ensure that we have a robust filing in the future, at least that is the intention.

是的。因此，在第二階段結束會議上，我們與 FDA 討論了各種主題，其中一些我們正在確保能夠在嚴重過敏反應的條件下管理和交付我們的產品，這是預期的，當然也是如此我們期待的對話。我們確實會繼續評估所有這些條件，這些條件最終都與您在 NDA 中的風險收益相關，這是我們在今年晚些時候與該機構討論的那次會議的一部分，目的是介紹我們在這方面的所有工作我們已經以正確的方式對所有內容進行了描述，並確保我們在未來擁有強大的歸檔，至少這是意圖。

Okay. Great. And then I just have one follow-up, if I may. So with the PDUFA for ARS Pharmaceuticals neffy coming up in mid-2023, if approved, do you think it is possible that FDA would eventually want to see 109 PK compared to neffy?

好的。偉大的。如果可以的話，我只有一個後續行動。因此，隨著 ARS Pharmaceuticals neffy 的 PDUFA 將於 2023 年年中推出，如果獲得批准，您認為 FDA 最終是否有可能希望看到與 neffy 相比的 109 PK？

I don't think that's -- I'm just thinking through the patent and looking at Steve. I don't think that's the way the pathway works. So this is not an orphan drug spot where suddenly there would be a need for some comparison or we don't see why that would occur. But we think our pharmacokinetic curve is very compelling, and we'll continue to compare it to the existing, already approved products, and we think that will be sufficient for the FDA.

我不認為那是——我只是在思考專利並看著史蒂夫。我認為這不是途徑的運作方式。所以這不是一個孤兒藥物點，突然需要進行一些比較，或者我們不明白為什麼會發生這種情況。但我們認為我們的藥代動力學曲線非常引人注目，我們將繼續將其與現有的、已經批准的產品進行比較，我們認為這對 FDA 來說已經足夠了。

This concludes our question-and-answer session. I'd like to turn the call back over to Dan for closing remarks.

我們的問答環節到此結束。我想將電話轉回 Dan 以作結束語。

Thank you, and thank you to all of you for joining us today. As I stated earlier in the call, we are going to remain very disciplined this year on ensuring we deliver on the things we have laid out, and that will continue to be rapidly progressing AQST-109 towards our pivotal study. We will continue to focus on expanding our collaborations, which will allow us to further strengthen our balance sheet. And of course, we do remain serious about finding the pathway for Libervant, both here and abroad to get it in the hands of patients. With that, we appreciate your joining us today, and we'll talk to you soon.

謝謝，也感謝大家今天加入我們。正如我早些時候在電話會議中所說的那樣，今年我們將保持紀律嚴明，以確保我們兌現我們已經制定的目標，這將繼續快速推進 AQST-109 向我們的關鍵研究邁進。我們將繼續專注於擴大我們的合作，這將使我們能夠進一步加強我們的資產負債表。當然，我們仍然認真地尋找 Libervant 的途徑，無論是在國內外，還是在患者手中。有了這個，我們感謝您今天加入我們，我們將很快與您交談。