BioXcel Therapeutics Inc (BTAI) 2023 Q1 法說會逐字稿

Good morning, and welcome to the BioXcel Therapeutics First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. During the conference you require operator assistance, please press *0 on your telephone keypad. After the presentation, there will be a question-and-answer session. If you would like to register a question, you may press *1 on your telephone keypad. Just to remind everyone, certain matters discussed in today's conference call and or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect future results are detailed in the company's annual report on Form 10-K for the year ended December 31, 2022, which can be found at www.bioxceltherapeutics.com or on www.sec.gov and which will be updated in its quarterly report on Form 10-Q for the quarter ended March 31, 2023. 

早上好，歡迎來到 BioXcel Therapeutics 2023 年第一季度財務業績電話會議。此時，所有參與者都處於只聽模式。會議期間您需要接線員協助，請按電話鍵盤上的*0。演講結束後，將進行問答環節。如果您想註冊一個問題，您可以按電話鍵盤上的 *1。提醒大家，今天電話會議中討論的某些事項和/或可能對所提問題的回答是前瞻性陳述，受與未來事件和/或公司未來財務或業務績效相關的風險和不確定性的影響.實際結果可能與這些前瞻性陳述中預期的結果存在重大差異。可能影響未來結果的風險因素詳見公司截至 2022 年 12 月 31 日止年度的 10-K 表格年度報告，可在 www.bioxceltherapeutics.com 或 www.sec.gov 上找到並將更新在截至 2023 年 3 月 31 日的季度的 10-Q 表季度報告中。

As a reminder, today's conference is being recorded. Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer; Richard Steinhart, Chief Financial Officer; Matt Wiley, Chief Commercial Officer; Dr. Rob Risinger, Chief Medical Officer of Neuroscience; Dr. Vince O'Neill, Chief R&D Officer of OnkosXcel Therapeutics; and Dr. Frank Yocca, Chief Scientific Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO and Founder of BioXcel Therapeutics. Please go ahead.

提醒一下，今天的會議正在錄製中。與我們一起參加今天電話會議的還有首席執行官 Vimal Mehta 博士；理查德·斯坦哈特，首席財務官；首席商務官 Matt Wiley；神經科學首席醫療官 Rob Risinger 博士； OnkosXcel Therapeutics 首席研發官 Vince O'Neill 博士；和首席科學官 Frank Yocca 博士。現在我很高興將電話轉給 BioXcel Therapeutics 的首席執行官兼創始人 Mehta 博士。請繼續。

Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss BioXcel Therapeutics First Quarter 2023 financial performance and business highlights. This is shaping up to be a momentous year for BioXcel Therapeutics. Our success in advancing our corporate objectives continues on an exciting trajectory. We are maturing as a commercial organization, solidifying our position as a leading innovator in a nascent agitation market and advancing our pipeline towards critical, value creative and business transformative milestones. We believe we are well on track to realizing our vision of becoming the leading AI-enabled neuroscience company. I have truly never been more excited than I am today for BioXcel's promising future. 

謝謝你，運營商。歡迎大家，並感謝您今天加入我們的電話會議，討論 BioXcel Therapeutics 2023 年第一季度的財務業績和業務亮點。對於 BioXcel Therapeutics 而言，今年將是重要的一年。我們在推進企業目標方面取得的成功繼續沿著令人興奮的軌道前進。作為一家商業組織，我們正在走向成熟，鞏固了我們在新興市場中作為領先創新者的地位，並將我們的管道推進到關鍵的、價值創造性的和業務轉型的里程碑。我們相信，我們正在朝著實現成為領先的 AI 神經科學公司的願景邁進。對於 BioXcel 充滿希望的未來，我真的從未像今天這樣興奮。

Now let me highlight our commercial progress and upcoming clinical milestones. On the commercial front, we continue to execute on our launch for IGALMI approved for the acute treatment of mild, moderate and severe forms of agitation associated with schizophrenia and bipolar disorders in adults. With our integrated commercial team now fully deployed for only 1 full quarter, we are already seeing encouraging market traction. For example, since our last earnings call, we have more than doubled our number of formulary wins. This is opening a significant addressable market opportunity for IGALMI. I would like to emphasize that we are continuing to build a new agitation market because IGALMI represents the first innovation for this indication in nearly a decade. While we recently celebrated the anniversary of IGALMI's FDA approval in April 2022, it is still less than 1 year since our trade launch last July. I am proud of the strong performance we have achieved to date and the real-world utility IGALMI is demonstrating. I will be sharing several inspirational anecdote of this later on the call. 

現在讓我強調我們的商業進展和即將到來的臨床里程碑。在商業方面，我們繼續執行 IGALMI 的發布，該藥物已獲准用於急性治療與成人精神分裂症和雙相情感障礙相關的輕度、中度和重度激越形式。我們的集成商業團隊現在僅用了一個完整的季度就完全部署了，我們已經看到了令人鼓舞的市場牽引力。例如，自上次財報電話會議以來，我們的處方藥獲勝數量增加了一倍多。這為 IGALMI 開闢了一個重要的可尋址市場機會。我想強調的是，我們正在繼續建立一個新的攪拌市場，因為 IGALMI 代表了近十年來針對該適應症的首次創新。雖然我們最近在 2022 年 4 月慶祝了 IGALMI 獲得 FDA 批准的周年紀念日，但距離我們去年 7 月推出貿易還不到一年。我為我們迄今為止取得的出色表現以及 IGALMI 在現實世界中展示的實用程序感到自豪。我將在稍後的電話會議上分享一些鼓舞人心的軼事。

On the clinical front, we are very excited for 3 key data readouts across our lead neuropsychiatric program, BXCL501. These data readouts are on track and expected to enable significant potential market expansion. The overall agitation market remains underdiagnosed and underserved. There are an estimated 139 million education episodes occurring each year in the U.S. across our 3 priority indications, bipolar disorder, schizophrenia and Alzheimer's disease. Similar large market exists for these conditions in other geographies outside the U.S. Starting with bipolar disorder and schizophrenia, we are looking to potentially expand into the at-home setting, where an estimated 23 million agitation episodes occur in the U.S. every year. Our SERENITY III program is investigating BXCL501 in this important setting through a 2-part study design. We anticipate announcing top line pivotal data from part 1 of the study this month. We also look forward to initiating part 2 of the study this quarter. 

在臨床方面，我們對我們的主要神經精神病學項目 BXCL501 的 3 個關鍵數據讀出感到非常興奮。這些數據讀數正在按計劃進行，預計將實現顯著的潛在市場擴張。整體攪拌市場仍然未得到充分診斷和服務。據估計，美國每年發生 1.39 億次教育事件，涉及我們的 3 個優先適應症，雙相情感障礙、精神分裂症和阿爾茨海默病。在美國以外的其他地區，這些疾病也存在類似的大市場。從雙相情感障礙和精神分裂症開始，我們希望有可能擴展到居家環境，據估計，美國每年有 2300 萬例躁動發作。我們的 SERENITY III 計劃正在通過兩部分研究設計在這一重要環境中研究 BXCL501。我們預計本月將公佈研究第 1 部分的重要關鍵數據。我們也期待在本季度啟動研究的第 2 部分。

Turning to Alzheimer's disease, a very large underserved market with no approved therapy, agitation episode are one of the primary reasons for these patients to move into long-term care facility. Up to an estimated 100 million agitation episodes occur annually in the U.S., our TRANQUILITY II program continues to advance, and we are on track to report top line data in June. In tandem, enrollment is advancing for TRANQUILITY III. Here, we are investigating 501 inpatients with moderate to severe dementia in long-term care facility. Outside of agitation, we are making strides towards unlocking BXCL501's full therapeutic potential. It has a novel mechanism of action for potential use as an adjunctive treatment for major depressive disorder. We look forward to sharing top line results from our Phase Ib multiple ascending dose trial this month. There are over 300 million antidepressant prescription filled annually in the U.S. Currently available treatment options are characterized by slow onset of action and incomplete response. We believe this represents a significant market opportunity as a chronic treatment in depression and in other neuropsychiatric conditions. 

談到阿爾茨海默氏病，這是一個非常大的服務不足的市場，沒有批准的治療方法，激越發作是這些患者進入長期護理機構的主要原因之一。據估計，美國每年發生多達 1 億次激動事件，我們的 TRANQUILITY II 計劃繼續推進，我們有望在 6 月份報告頂級數據。與此同時，TRANQUILITY III 的註冊正在推進。在這裡，我們正在調查長期護理機構中 501 名患有中度至重度癡呆症的住院患者。除了激動之外，我們正在朝著解鎖 BXCL501 的全部治療潛力邁進。它具有一種新的作用機制，可作為重度抑鬱症的輔助治療。我們期待在本月分享我們的 Ib 期多次遞增劑量試驗的頂級結果。美國每年有超過 3 億張抗抑鬱藥處方。目前可用的治療方案的特點是起效緩慢和反應不完全。我們認為，作為抑鬱症和其他神經精神疾病的慢性治療，這代表了一個重要的市場機會。

Turning to OnkosXcel Therapeutics. We remain excited about our subsidiaries potential. We continue to explore the strategic options for this business and advance our immuno-oncology clinical pipeline. In the second half of this year, we expect to initiate our randomized Phase IIb trial, evaluating BXCL701 as monotherapy and in combination with KEYTRUDA for small cell neuroendocrine prostate cancer SCNC. This trial could serve as a potential registration study for SCNC pending our discussions with the FDA. There are an estimated 288,000 new prostate cancer patients expected in the U.S. this year with approximately 11,500 progressing to SCNC. This patient population is entire need of treatment options as there are no approved FDA therapies. To close, we have had a very productive quarter and have laid a solid foundation for many near-term exciting development. I'm confident we will continue to meet the high expectations we have set forth for ourselves. With that, I would now like to turn the call over to Rob Risinger to provide some additional details on our 3 upcoming data readout this quarter. Rob?

轉向 OnkosXcel Therapeutics。我們仍然對我們子公司的潛力感到興奮。我們繼續探索這項業務的戰略選擇，並推進我們的免疫腫瘤學臨床管線。在今年下半年，我們預計將啟動我們的隨機 IIb 期試驗，評估 BXCL701作為單一療法並與 KEYTRUDA 聯合治療小細胞神經內分泌前列腺癌 SCNC。在我們與 FDA 討論之前，該試驗可以作為 SCNC 的潛在註冊研究。據估計，今年美國將有 288,000 名新的前列腺癌患者，其中約有 11,500 名進展為 SCNC。由於沒有獲得 FDA 批准的療法，因此該患者群體完全需要治療選擇。結束時，我們有一個非常富有成效的季度，並為許多近期令人興奮的發展奠定了堅實的基礎。我相信我們將繼續滿足我們為自己設定的高期望。有了這個，我現在想把電話轉給 Rob Risinger，以提供有關本季度即將發布的 3 個數據的一些額外細節。搶？

Thank you, Vimal. This is indeed a very exciting time for our neuroscience clinical pipeline at BioXcel Therapeutics. We are expecting 3 near-term data readouts across the BXCL501 program. These will potentially help expand this novel asset outside of the institutional setting and into additional therapeutic areas of significant unmet need. Let me briefly summarize these important milestones, their clinical relevance and significance. We are on track to announce top line data in schizophrenia and bipolar disorder from part 1 of our SERENITY III study this month. This study will report both efficacy and safety information for a 60-microgram dose. Given the purpose of this study, we chose a lower dose to help establish a greater safety margin for at-home use while maintaining a margin of efficacy. Dose selection was informed by our experience with the 60-microgram dose in our Phase Ib trial. Our goal is to arrest agitation episodes in its earliest stages at home. Patients at home are aware of becoming agitated and have not yet reached the magnitude requiring emergency treatment. This contrast with the magnitude of improvements in PEC total score in SERENITY I and II, which were designed for the emergency setting, where patients require a rapid onset of action, considering their acuity. 

謝謝你，維馬爾。對於我們在 BioXcel Therapeutics 的神經科學臨床管道來說，這確實是一個非常激動人心的時刻。我們預計整個 BXCL501 計劃將有 3 個近期數據讀數。這些將可能有助於將這種新資產擴展到機構環境之外，並進入其他嚴重未滿足需求的治療領域。讓我簡要總結一下這些重要的里程碑、它們的臨床相關性和意義。我們有望在本月公佈我們 SERENITY III 研究第 1 部分的精神分裂症和雙相情感障礙的頂級數據。該研究將報告 60 微克劑量的療效和安全性信息。鑑於本研究的目的，我們選擇了較低的劑量以幫助建立更大的家庭使用安全範圍，同時保持療效範圍。劑量選擇是根據我們在 Ib 期試驗中使用 60 微克劑量的經驗得出的。我們的目標是在家中儘早阻止躁動發作。家中患者自覺情緒激動，尚未達到需要緊急治療的程度。這與 SERENITY I 和 II 中 PEC 總分的改善幅度形成對比，SERENITY I 和 II 是為緊急情況設計的，考慮到他們的敏銳度，患者需要快速開始行動。

In Part 1 of the SERENITY III study, we have 80% power for a single 60-microgram dose to separate from placebo by 1 point or greater in the PEC total score with an alpha of 0.05 or better. For potential home use, we have powered the SERENITY III trial for a dose intended to maximize the margin of safety for broader community use. Data cleaning and verification is in progress with expected readout this month. Part 2 of our SERENITY III study is expected to initiate this quarter and is designed to evaluate the safety of a 60-microgram dose plus a second dose, if required at home. Let me turn now to TRANQUILITY II, which is evaluating 501 for the acute treatment of Alzheimer's-related agitation in assisted living facilities and residential settings. The primary endpoint is the change in baseline PEC total scores 2 hours after the first dose as in TRANQUILITY I and treatment over a 3-month observation period. Confirmatory measures include the Clinical Global Impression of Improvement, the Pittsburgh Agitation Scale and Agitation Calmness Evaluation Scale. 

在 SERENITY III 研究的第 1 部分中，我們有 80% 的功效使單次 60 微克劑量與安慰劑在 PEC 總分中的 alpha 為 0.05 或更好時相差 1 分或更高。對於潛在的家庭使用，我們已經為 SERENITY III 試驗提供了動力，其劑量旨在最大限度地提高更廣泛社區使用的安全邊際。數據清理和驗證正在進行中，預計將在本月公佈。我們的 SERENITY III 研究的第 2 部分預計將於本季度啟動，旨在評估 60 微克劑量加第二劑（如果需要在家中服用）的安全性。現在讓我談談 TRANQUILITY II，它正在評估 501 在輔助生活設施和住宅環境中對阿爾茨海默氏症相關躁動的急性治療。主要終點是在 TRANQUILITY I 中首次給藥後 2 小時基線 PEC 總分的變化以及 3 個月觀察期內的治療。確認措施包括臨床整體改善印象、匹茲堡激越量表和激越冷靜評估量表。

In TRANQUILITY I, we observed statistical significance for the primary endpoint as well as efficacy across these confirmatory measures for the 60-microgram dose. The data cleaning and verification process is underway. We expect to announce top line data from this pivotal trial in June. Lastly, our Phase Ib multiple ascending dose trial was designed to test safety and tolerability of daily dosing of BXCL501 for 7 days in healthy volunteers to inform proof-of-concept trial, dose selection. In Phase II program, treatment in MDD patients will be evaluated with BXCL501 in combination with first initiation of selective serotonin or serotonin norepinephrine reuptake inhibitors, SSRIs or SNRIs, respectively, in order to assess accelerating the response to an antidepressant. This study lays the foundation for combination of BXCL501 with antidepressants for MDD and for the potential chronic dosing in a variety of other neuropsychiatric conditions. We anticipate announcing top line results this month. To summarize, over the next several weeks, we expect to announce key data via 3 separate readouts for BXCL501, with plans intended to further unlock this asset's full therapeutic potential by demonstrating its ability to treat agitation across additional indications in additional medical settings and potential expansion into illnesses, which require chronic dosing. Let me now turn the call over to Matt for an overview of our commercial progress. Matt?

在 TRANQUILITY I 中，我們觀察到主要終點的統計顯著性以及 60 微克劑量的這些確認措施的療效。數據清理和驗證過程正在進行中。我們預計將在 6 月公佈這一關鍵試驗的最高數據。最後，我們的 Ib 期多次遞增劑量試驗旨在測試健康志願者連續 7 天每天服用 BXCL501 的安全性和耐受性，以便為概念驗證試驗和劑量選擇提供信息。在 II 期項目中，將評估 BXCL501聯合首次啟動選擇性血清素或血清素去甲腎上腺素再攝取抑製劑、SSRIs 或 SNRIs 對 MDD 患者的治療，以評估加速對抗抑鬱藥的反應。該研究為 BXCL501 與抗抑鬱藥聯合治療 MDD 以及在各種其他神經精神疾病中潛在的慢性給藥奠定了基礎。我們預計本月將公佈最高業績。總而言之，在接下來的幾週內，我們預計將通過 BXCL501 的 3 個獨立讀數公佈關鍵數據，併計劃通過展示其在其他醫療環境和潛在擴展中針對其他適應症治療躁動的能力，進一步釋放該資產的全部治療潛力進入疾病，需要長期服用。現在讓我把電話轉給馬特，了解一下我們的商業進展。馬特？

Thank you, Rob, and good morning, everyone. Before we dive into the specific commercial metrics for the quarter, I want to score IGALMI's positive reception as our commercial organization continues to build and shape the agitation treatment market. Following the full deployment of our 70-person field force last December and building upon a strong early launch foundation, we've had a very productive first quarter and start to the second quarter across our sales, market access and marketing functions. While we're still relatively early in the hospital launch, particularly for the recently deployed 2/3 of our field force, our commercial momentum is building. We are very enthusiastic about our progress and confident in our prospects for success. The team is working diligently to ensure IGALMI is on hospital shelves and available to patients as quickly as possible. We have made great progress with IGALMI's formulary adoption, achieving more than 130 formulary wins, which more than doubled the number of wins reported just 2 months ago. 

謝謝羅布，大家早上好。在我們深入探討本季度的具體商業指標之前，我想對 IGALMI 的積極評價表示讚賞，因為我們的商業組織繼續建立和塑造攪拌治療市場。在去年 12 月全面部署我們的 70 人現場工作人員並建立在強大的早期啟動基礎之上之後，我們在第一季度取得了非常高產，並從我們的銷售、市場准入和營銷職能開始進入第二季度。雖然我們在醫院啟動方面還處於相對較早的階段，特別是對於最近部署的 2/3 的現場人員，但我們的商業勢頭正在增強。我們對我們的進步充滿熱情，並對我們的成功前景充滿信心。該團隊正在努力確保 IGALMI 上架醫院並儘快提供給患者。我們在 IGALMI 的處方採用方面取得了很大進展，取得了 130 多項處方勝利，比 2 個月前報告的勝利數量增加了一倍多。

Along with approvals for over 14,000 Target Integrated Delivery Network or IDN beds, this equates to over $55 million addressable market that has been unlocked to date. Beyond these secured approvals, the efforts of our combined field teams have resulted in formulary votes scheduled for approximately 600 hospital P&T committees and for IDNs covering another 70,000 target beds. This represents 25% of our target IDN universe. Taken together, this represents approximately an additional $255 million in market opportunity that's scheduled to vote. We're pleased with our current approval rate of nearly 70% of votes. This reinforces our confidence in IGALMI's perceived value to our hospital customers. Given the standard formulary time lines, we expect to see a meaningful uptick in votes in process later this year. We have also observed that more than half of all ordering hospitals have reordered, which we believe demonstrates real-world utility and growing health care provider interest in the value of IGALMI. To provide additional color on this, we recently analyzed our top hospital accounts to benchmark IGALMI adoption.

連同超過 14,000 個 Target Integrated Delivery Network 或 IDN 床位的批准，這相當於迄今為止已解鎖的超過 5500 萬美元的潛在市場。除了這些安全的批准之外，我們聯合現場團隊的努力已經為大約 600 個醫院 P&T 委員會和覆蓋另外 70,000 張目標床位的 IDN 進行了預定投票。這占我們目標 IDN 範圍的 25%。總而言之，這意味著計劃投票的市場機會增加了約 2.55 億美元。我們對目前近 70% 的選票支持率感到滿意。這增強了我們對 IGALMI 對我們醫院客戶的感知價值的信心。考慮到標準的公式時間表，我們預計今年晚些時候進行中的投票將出現有意義的上升。我們還觀察到，超過一半的訂購醫院已經重新訂購，我們認為這表明了現實世界的效用和醫療保健提供者對 IGALMI 價值的興趣不斷增長。為了對此提供額外的顏色，我們最近分析了我們的頂級醫院賬戶，以對 IGALMI 的採用進行基準測試。

Our target hospitals each manage over 4,000 agitation episodes per year, and we estimate that each of our early adopting institutions have treated over 160 episodes in the first 6 months of use. This represents an implied market share of over 4% in that short time period. We have provided this uptake case study on Slide 25 in our corporate presentation, which was posted this morning on our company's website. Our broader integrated commercial team continues to increase awareness of IGALMI and further amplify our message. The sales team has reached over 75% of the 1,700 targeted hospitals with focus on deepening advocacy and driving demand. Late in the first quarter, we successfully deployed our IGALMI hospital free trial program and since then have observed nearly 700 ordering website interactions with several early orders having already shipped. This program is designed to facilitate early experience with IGALMI and to support hospitals and health systems and value determination. We expect this will help accelerate demand for IGALMI in de novo institutions nationwide. 

我們的目標醫院每年處理超過 4,000 次情緒激動事件，我們估計我們的每個早期採用機構在使用的前 6 個月內治療了超過 160 次事件。這表示在短時間內隱含的市場份額超過 4%。我們在今天上午發佈在我們公司網站上的公司演示文稿中提供了幻燈片 25 中的這個吸收案例研究。我們更廣泛的綜合商業團隊繼續提高對 IGALMI 的認識並進一步擴大我們的信息。銷售團隊已覆蓋 1,700 家目標醫院中的 75% 以上，重點是深化宣傳和推動需求。在第一季度末，我們成功部署了 IGALMI 醫院免費試用計劃，此後觀察到近 700 次訂購網站互動，其中幾個早期訂單已經發貨。該計劃旨在促進 IGALMI 的早期體驗，並支持醫院和衛生系統以及價值確定。我們預計這將有助於加速全國新機構對 IGALMI 的需求。

Additional marketing efforts have bolstered customer engagement and include over 90 peer-to-peer speaker programs so far in 2023, educating nearly 1,300 health care providers. Our comprehensive first half media blitz has generated over 12 million impressions in the first quarter, which represents a 70% quarter-over-quarter increase. We expect these enhanced sales and marketing efforts will drive a meaningful acceleration in formulary voting volume and increased pull-through demand as we move throughout the year. In summary, all early indicators are tracking well and point to growing revenue uptick in the second half of 2023. We are incredibly pleased with our progress to date and look forward to leveraging and building upon these efforts as we generate further demand and unlock additional opportunity for IGALMI to reach patients in need. I'll now turn the call over to Richard, who will discuss first quarter financial results. Rich?

額外的營銷工作加強了客戶參與度，包括到 2023 年為止的 90 多個點對點演講計劃，為近 1,300 名醫療保健提供者提供了教育。我們全面的上半年媒體閃電戰在第一季度產生了超過 1200 萬次展示，環比增長 70%。我們預計，隨著我們全年的行動，這些加強的銷售和營銷工作將推動公式投票量的顯著加速和拉動需求的增加。總而言之，所有早期指標都跟踪良好，並表明 2023 年下半年收入將增長。我們對迄今為止取得的進展感到非常滿意，並期待在我們產生更多需求並釋放更多機會時利用和鞏固這些努力使 IGALMI 能夠到達有需要的患者。我現在將電話轉給理查德，他將討論第一季度的財務業績。富有的？

Thank you, Matt. I will now review the first quarter 2023 financial results. Net revenue was approximately $206,000 for the quarter, similar to our prior quarter. We expect to see a notable uptick in revenue in the second half of the year as we believe we will continue to accrue more formulary approvals. Research and development expenses were $27.8 million for the first quarter of 2023 compared to $18.6 million for the same period in 2022. The increased expenses were primarily attributable to multiple clinical trials and CMC costs related to our upcoming 3 data readouts. Sales, general and administrative expenses were $23.6 million for the first quarter of 2023 as compared to $12.9 million for the same period in 2022. The increased expenses were primarily attributable to personnel, sales, market access and marketing costs associated with the commercialization of IGALMI in the United States. BioXcel Therapeutics had a net loss of $52.8 million for the first quarter of 2023 compared to a net loss of $31.5 million in the same period of 2022. Cash and cash equivalents totaled $165.5 million as of March 31, 2023. We believe that full execution of our strategic financing with Oaktree and Qatar Investment Authority and IGALMI revenues will result in a cash runway into 2025. Thank you. Now I'd like to turn the call back to Vimal.

謝謝你，馬特。我現在將回顧 2023 年第一季度的財務業績。本季度淨收入約為 206,000 美元，與上一季度相似。我們預計下半年收入將顯著增加，因為我們相信我們將繼續獲得更多的處方批准。 2023 年第一季度的研發費用為 2780 萬美元，而 2022 年同期為 1860 萬美元。費用增加的主要原因是與我們即將進行的 3 次數據讀取相關的多項臨床試驗和 CMC 費用。 2023 年第一季度的銷售、一般和行政費用為 2360 萬美元，而 2022 年同期為 1290 萬美元。費用增加的主要原因是與 IGALMI 在美國商業化相關的人員、銷售、市場准入和營銷成本美國。 BioXcel Therapeutics 2023 年第一季度淨虧損 5280 萬美元，而 2022 年同期淨虧損 3150 萬美元。截至 2023 年 3 月 31 日，現金和現金等價物總計 1.655 億美元。我們認為全面執行我們與 Oaktree 和卡塔爾投資局的戰略融資以及 IGALMI 的收入將導致到 2025 年的現金跑道。謝謝。現在我想把電話轉回 Vimal。

Thank you, Richard. Before turning to Q&A, I would like to briefly highlight a few of the many recent unsolicited real-world examples that were relayed to me by our sales organization. These 2 anecdotes demonstrate the profound benefit IGALMI is having for patients and caregivers. An STP customer last week described a highly agitated uncontrollable patient who were jumping on the bed, taking their clothes off and yelling. The patient appears to be a danger to themselves and to hospital staff. The patient was offered IGALMI, took the drug and in under 30 minutes was sitting back on the back, fully dressed and much more cooperative. The psychiatrist feedback was that IGALMI worked fabulously for this patient. Another hospital informed us that they have multiple patients coming in and requesting IGALMI by its name. One of these patients after taking IGALMI was described by her caregivers as firm, clear headed and able to hold conversations. And that she desperately wanted to get IGALMI to use at home. As you are aware, BXCL501 is currently under investigation for at-home use. 

謝謝你，理查德。在轉向問答環節之前，我想簡要地強調一下我們的銷售組織最近主動提供給我的許多真實示例中的幾個。這兩個軼事證明了 IGALMI 對患者和護理人員的深遠好處。一位 STP 客戶上週描述了一位情緒激動且無法控制的患者，他跳到床上，脫掉衣服並大喊大叫。患者似乎對自己和醫院工作人員構成危險。患者服用了 IGALMI，服藥後不到 30 分鐘就可以仰面坐下，穿好衣服並且更加合作。精神科醫生的反饋是 IGALMI 對這名患者非常有效。另一家醫院告訴我們，他們有多名患者進來並要求 IGALMI 的名字。其中一名患者在服用 IGALMI 後被她的護理人員描述為堅定、頭腦清醒並且能夠進行對話。而且她非常想讓 IGALMI 在家裡使用。如您所知，BXCL501 目前正在接受家庭使用調查。

We are constantly receiving such anecdotal feedback, which further assures us that not only is IGALMI providing real-world utility for those in need in the institutional setting, but it also supports our expansion strategy. Hearing first-hand accounts of these positive changes we are creating also continues to be both ratifying and motivating. As you know, we are beginning to make an important societal chain. We would now like to open the call for questions. Operator?

我們不斷收到此類軼事反饋，這進一步使我們確信，IGALMI 不僅為機構環境中有需要的人提供了現實世界的效用，而且還支持我們的擴張戰略。聽到我們正在創造的這些積極變化的第一手資料也繼續既是認可又是激勵。如您所知，我們正在開始建立一個重要的社會鏈。我們現在想開始提問。操作員？

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions). One moment please while we poll for your questions. Our first questions come from the line of Robyn Karnauskas with Truist Securities. Please proceed with your questions.

謝謝。我們現在將進行問答環節。 （操作員說明）。請稍等片刻，我們將輪詢您的問題。我們的第一個問題來自 Truist Securities 的 Robyn Karnauskas。請繼續回答您的問題。

Great. Thank you guys. So I have one main one and then 2 follow-ups. So with regard to SERENITY III, thank you for giving the powering, but what can we expect for the bar to be considered successful in terms of the PET score change in regulatory approval?

偉大的。感謝你們。所以我有一個主要的，然後是 2 個後續的。因此，關於 SERENITY III，感謝您提供的支持，但我們可以期望在監管批准中的 PET 分數變化方面，該酒吧被認為是成功的嗎？

So I appreciate that there's confusion over the magnitude of change in PEC total score, which could be considered approvable by regulatory authorities. So I'll be clear. The magnitude does not have to be large. As always, for regulators, it's the safety that allows approval, hopefully, for at-home use. Safety is the critical bar for FDA to approve any drug for at-home use. So for example, look at Flonase or Claritin or older treatments even like Tylenol, not only were lower doses approved, but the increased margin of safety was really enabling for these drugs to move all the way to nonprescription over-the-counter use. So to back it up for a moment, our overall regulatory strategy has been built upon moving a drug routinely used in the ICU setting and gaining our initial approval, demonstrating discrete low exposure to treat agitation in an emergency room at the 120 and 180 microgram doses. This trial, SERENITY III, is next designed in order to potentially expand upon this safety to potentially enable approval for at-home use. 

因此，我理解人們對 PEC 總分變化幅度的混淆，這可能被監管機構認為是可以批准的。所以我會很清楚。幅度不必很大。與往常一樣，對於監管機構而言，安全是允許在家中使用的批准，希望如此。安全性是 FDA 批准任何家用藥物的關鍵標準。因此，例如，看看 Flonase 或 Claritin 或更老的治療方法，甚至像 Tylenol，不僅批准了較低劑量，而且安全邊際的增加確實使這些藥物能夠一路轉向非處方非處方藥。因此，暫時支持一下，我們的總體監管策略是建立在移動 ICU 環境中常規使用的藥物並獲得我們的初步批准的基礎上的，這表明在急診室以 120 和 180 微克劑量治療躁動的離散低暴露.該試驗 SERENITY III 的下一步設計是為了潛在地擴展這種安全性，從而有可能獲得家庭使用的批准。

Although low doses of drugs have been approved with marginal statistical significance, achieving significance versus placebo is, of course, the regulatory bar. So to answer your question, this study is engineered to achieve this. Prior to initiating our pivotal SERENITY I and II trials. We tested the 60-microgram dose in a dose-ranging trial in schizophrenia. We observed a group mean difference versus placebo of 1 point or greater across multiple time points through 2 hours. This data set was the basis for our initial powering assumptions, where an (inaudible) 200 provides 80% power to detect a statistical separation from placebo with an alpha of 0.05 on the change from baseline in PEC total score. So to confirm that estimate, after 40% of subjects were enrolled in SERENITY III, we conducted a blinded interim sample size re-estimate which concluded a sample size increase was not necessary. Therefore, with 200 total patients randomized at 1:1 ratio, meaning 100 assigned a drug, 100 assigned to placebo. This provides 80% power to detect a significant difference versus placebo. 

儘管低劑量藥物已獲批准，但具有邊際統計學意義，但與安慰劑相比達到顯著性當然是監管障礙。因此，為了回答您的問題，本研究旨在實現這一目標。在開始我們關鍵的 SERENITY I 和 II 試驗之前。我們在精神分裂症的劑量範圍試驗中測試了 60 微克的劑量。我們在 2 小時內的多個時間點觀察到與安慰劑相比的組平均差異為 1 分或更大。該數據集是我們初始動力假設的基礎，其中（聽不清）200 提供 80% 的動力來檢測與安慰劑的統計分離，PEC 總分相對於基線的變化的 alpha 為 0.05。因此，為了證實這一估計，在 40% 的受試者參加 SERENITY III 後，我們進行了盲法中期樣本量重新估計，得出的結論是沒有必要增加樣本量。因此，總共有 200 名患者以 1:1 的比例隨機分配，這意味著 100 名患者分配了藥物，100 名患者分配了安慰劑。這提供了 80% 的能力來檢測與安慰劑的顯著差異。

That's a lot of color. You actually answered a bunch of my follow-ups. So thank you very much. Appreciate it.

那是很多顏色。你實際上回答了我的一堆後續問題。非常感謝。欣賞它。

Thanks, Robyn.

謝謝，羅賓。

Thank you. Our next questions come from the line of Greg Harrison with Bank of America. Please proceed with your questions.

謝謝。我們的下一個問題來自美國銀行的 Greg Harrison。請繼續回答您的問題。

Good morning. This is Mary Kate on for Greg. Thanks for taking my questions. Maybe also looking at the at-home setting here. I guess, how are you looking at the potential commercialization strategy for the setting, if approved, compared to the ongoing institutional setting?

早上好。這是格雷格的瑪麗凱特。感謝您回答我的問題。也許還看看這裡的居家環境。我想，與正在進行的機構設置相比，如果獲得批准，您如何看待該設置的潛在商業化策略？

Yes. So it's a great question. We're going to provide more color on at least a 30,000-foot view of the market, market reaction and potential deployment scenarios as we read that data out. So stay tuned on that. Suffice to say that we're building momentum now and a very nice bridge to get to the community. I think as Vimal mentioned, we had a case of -- and we've had several instances across the country where patients who've already received IGALMI have asked if they could have this therapy at home. So we believe that, that bridge will be very strong and will accelerate our uptake into that market.

是的。所以這是一個很好的問題。我們將在至少 30,000 英尺的市場視圖、市場反應和潛在部署場景中提供更多顏色，因為我們會讀出這些數據。所以請繼續關注。可以說我們現在正在建立勢頭，並且是通往社區的非常好的橋樑。我認為正如 Vimal 提到的那樣，我們有一個案例——我們在全國有幾個例子，已經接受 IGALMI 的患者詢問他們是否可以在家裡接受這種治療。因此，我們相信，這座橋樑將非常堅固，並將加速我們進入該市場。

Great. Thanks. And just one more, if I could. Then we'll discuss with the anecdotal feedback. Maybe just looking at another setting here. As you enroll patients for the TRANQUILITY III trial, could you comment on the interest you're receiving from physicians and caregivers for 501 in Alzheimer's?

偉大的。謝謝。還有一個，如果可以的話。然後我們將討論軼事反饋。也許只是在這裡看另一個設置。當您為 TRANQUILITY III 試驗招募患者時，您能否評論一下醫生和護理人員對 501 治療阿爾茨海默病的興趣？

I can say there is interest. At this point, we're not approved for use, for example, in a nursing home setting, and we're also not approved for use in Alzheimer's. However, we are studying this. So I encourage family members and patients to stay tuned. We are going to present this data to the FDA post-haste, extremely fast. And as you know, we have breakthrough designation for the development and fast track. So we hope to meet with the FDA probably shortly after we describe the top line results to investors.

我可以說有興趣。在這一點上，我們還沒有被批准用於，例如，在療養院環境中，我們也沒有被批准用於阿爾茨海默氏症。然而，我們正在研究這個。所以我鼓勵家人和患者繼續關注。我們將以極快的速度向 FDA 提交這些數據。如您所知，我們對開發和快速通道進行了突破性指定。因此，我們希望在我們向投資者描述頂線結果後不久與 FDA 會面。

Thank you.

謝謝。

Thank you. Our next questions come from the line of Colin Bristow with UBS. Please proceed with your questions.

謝謝。我們的下一個問題來自 Colin Bristow 與 UBS 的聯繫。請繼續回答您的問題。

Hey, good morning and thanks for taking the questions. I guess the main one that we've been getting from investors is just what is the disconnect between these improving metrics you're getting in terms of formulary wins and institutional outreach, et cetera, versus the sort of essentially sort of flat sales performance? And when do we start to see the correlation between these metrics and the sales performance? And then just as a follow-up to this, can you give any metrics in terms of repeat orders? And then I have a follow-on up to that. Thanks.

嘿，早上好，感謝您提出問題。我想我們從投資者那裡得到的主要信息是，您在公式化勝利和機構外展等方面獲得的這些改進指標與基本持平的銷售業績之間的脫節是什麼？我們什麼時候開始看到這些指標與銷售業績之間的相關性？然後作為對此的後續行動，你能給出重複訂單方面的任何指標嗎？然後我有一個後續行動。謝謝。

Sure. So I'll address the question about revenue versus the metrics. I mean the metrics that we focus on is obtaining formulary wins because that is a leading indicator, revenue is a lagging indicator. Revenue can be -- the gating of that revenue can be disjointed, especially early in launch. And so I think that you're seeing the phenomenon of that now. As hospitals order in units, they may work through that inventory before reorder. We cannot predict those ordering patterns. It should smooth out over time, and we expect it to. And as I said before, we expect to see a significant inflection in the revenue later this year.

當然。因此，我將解決有關收入與指標的問題。我的意思是我們關注的指標是獲得處方勝利，因為這是一個領先指標，收入是一個滯後指標。收入可以——收入的門控可以脫節，尤其是在發布初期。所以我認為你現在看到了這種現象。當醫院按單位訂購時，他們可能會在重新訂購之前處理完該庫存。我們無法預測那些排序模式。隨著時間的推移，它應該會逐漸平息，我們希望如此。正如我之前所說，我們預計今年晚些時候收入將出現重大變化。

And then on the repeat orders, can you give any color there?

然後在重複訂單上，你能給那裡任何顏色嗎？

Yes. So I would point you to that Slide 25 in the corporate deck that we posted this morning. That will give you a really good indication of the ramp that we're seeing in the hospitals that have begun order now. The way that we had to perform that analysis is they had to have ordered at least for 6 months and had to have some experience with the drug. But what you're seeing there is a pretty nice inflection. In fact, we get to, I think 4.3% on average impact or penetration into that annual agitation market. So I think that, that's a fairly useful way of maybe predicting the ramp. We've had, we've observed over half of our ordering hospitals have reordered. And that's the expected early launch. I mean remember, as we pull new hospitals online and they place their first order, if we're including those in the calculation as we do, they will have ordered one time. And so we expect them to have repeat orders. And in fact, we've seen that as hospitals trial this in patients in their hospital, they're pretty impressed with its performance.

是的。因此，我會向您指出我們今天早上發布的公司幻燈片中的幻燈片 25。這將使您很好地了解我們在現在已經開始訂購的醫院中看到的坡道。我們必須執行該分析的方式是他們必須訂購至少 6 個月並且必須有一些藥物使用經驗。但是你所看到的是一個非常好的拐點。事實上，我認為我們平均影響或滲透到該年度攪拌市場的 4.3%。所以我認為，這可能是預測斜坡的一種相當有用的方法。我們已經，我們已經觀察到超過一半的訂購醫院已經重新訂購。這是預期的早期發布。我的意思是請記住，當我們將新醫院拉到網上，他們下了第一筆訂單時，如果我們像現在這樣將這些包括在計算中，他們就會訂購一次。所以我們希望他們有重複的訂單。事實上，我們已經看到，當醫院在他們醫院的病人身上進行試驗時，他們對它的表現印象深刻。

Okay. Great. And then just as we look forward to the Alzheimer's launch, which I think is the focus of everyone, should we expect a similar lag between these metrics and the sales performance? Or because you'll be so established at that point, do you expect sort of a much greater correlation and more rapid uptake. Thank you.

好的。偉大的。然後就像我們期待阿爾茨海默氏症的推出一樣，我認為這是每個人的焦點，我們是否應該期望這些指標與銷售業績之間存在類似的滯後？或者因為你會在那個時候建立起來，你是否期望更大的相關性和更快的吸收。謝謝。

So that's a great question, Colin. And no, we wouldn't expect that. I mean this is a traditional Rx therapy. So we would expect to see the same type of ramps that you see in traditional retail markets. And in fact, being able to build that bridge from the hospital experience to the community, even in Alzheimer's dementia is going to be very important. Remember, 20% of those 100 million episodes in Alzheimer's dementia wind up in the emergency department where we're going to have a lot of experience with IGALMI and bipolar in schizophrenia patients. So we expect to leverage that and build a similar request for those patients who have been treated with IGALMI to go back out in the community and request it from their physicians.

所以這是一個很好的問題，科林。不，我們不希望那樣。我的意思是這是一種傳統的 Rx 療法。因此，我們希望看到您在傳統零售市場看到的相同類型的坡道。事實上，能夠建立從醫院經驗到社區的橋樑，即使在阿爾茨海默氏癡呆症中也是如此。請記住，在阿爾茨海默氏癡呆症的 1 億次發作中，有 20% 發生在急診室，我們將在急診室獲得大量 IGALMI 和雙相精神分裂症患者的經驗。因此，我們希望利用這一點，並為那些接受過 IGALMI 治療的患者提出類似的要求，讓他們回到社區並向他們的醫生提出要求。

Okay. So that's really helpful. Thanks a lot, guys.

好的。所以這真的很有幫助。非常感謝，伙計們。

Thank you. Our next questions come from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your questions.

謝謝。我們的下一個問題來自 Corinne Jenkins 與 Goldman Sachs 的對話。請繼續回答您的問題。

Hi. This is (inaudible) on for Corinne. I have a couple of questions. So post SERENITY III, how do you expect doctors to determine the dose in the emergency room setting. And then should they choose to use the lower dose? Are there any implications to revenue we should be thinking about?

你好。這是（聽不清）Corinne 的發言。我有一些問題。所以在 SERENITY III 之後，您如何期望醫生在急診室環境中確定劑量。然後他們應該選擇使用較低的劑量嗎？我們應該考慮對收入有什麼影響嗎？

So the approved and labeled doses are 120 and 180 micrograms, which may be given again half doses, 2 hours after the first dose in the emergency room or hospital setting. The 60-microgram dose is being tested for at-home use.

因此，批准和標註的劑量為 120 和 180 微克，可以在急診室或醫院環境中首次給藥 2 小時後再次給予半劑量。 60 微克的劑量正在接受家庭使用測試。

And this is Vimal. I can add that currently, there is no differential based on the dose, whether it's 120 or 180, our price is same.

這是Vimal。我可以補充一點，目前沒有劑量差異，無論是120還是180，我們的價格都是一樣的。

That's helpful. And my other question was, could you contextualize the risk of falls in the TRANQUILITY study? And what do you view as a tolerable rate within this population?

這很有幫助。我的另一個問題是，您能否將 TRANQUILITY 研究中的跌倒風險背景化？您認為這個人群中可以接受的比率是多少？

So we know that agitation itself is a risk factor for falls. Obviously, the population is at risk, elderly, especially patients with multiple comorbidities, hypertension and on antihypertensives. These are all reasons why patients fall. And so I don't know that the -- a single fall is not a good thing. It never is. Falls with consequence are worse, consequence, like broken hips and arms and bones. And so we'll be monitoring this. In fact, we are monitoring this, and we'll be presenting data on this as part of our regulatory package and you will see this as part of our safety data in the top line results.

所以我們知道激動本身就是跌倒的危險因素。顯然，人群處於危險之中，老年人，尤其是患有多種合併症、高血壓和服用抗高血壓藥的患者。這些都是患者跌倒的原因。所以我不知道 - 一次跌倒不是一件好事。它從來沒有。跌倒的後果更嚴重，後果，如骨折的臀部、手臂和骨頭。因此，我們將對此進行監控。事實上，我們正在監測這一點，我們將把這方面的數據作為我們監管計劃的一部分，你會在頂線結果中看到這作為我們安全數據的一部分。

That's helpful, thank you.

這很有幫助，謝謝。

Thank you. Our next questions come from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your questions.

謝謝。我們的下一個問題來自 Yatin Suneja 與 Guggenheim Partners 的合作。請繼續回答您的問題。

Hey guys, thank you. A question on the TRANQUILITY II. So I think the primary endpoint is at day 1, but the study is 3 months. Could you maybe articulate for us how did you come up with the 3-month study, at least in the open label? What sort of regulatory discussions were? And then in terms of filing requirements, help us understand what would be needed. Do you need III or TRANQUILITY III to read out or II enough? Just curious how did you come up with the -- what the negotiation of back and forth was with the FDA when you were designing the II and III TRANQUILITY II and III studies. Thanks.

嘿伙計們，謝謝你們。關於 TRANQUILITY II 的問題。所以我認為主要終點是第 1 天，但研究是 3 個月。您能否為我們闡明您是如何提出為期 3 個月的研究的，至少是在開放標籤中？什麼樣的監管討論是？然後在備案要求方面，幫助我們了解需要什麼。你需要III或TRANQUILITY III讀出還是II就夠了？只是好奇你是怎麼想到的——當你設計 II 和 III TRANQUILITY II 和 III 研究時，與 FDA 的來回談判是什麼。謝謝。

Sure. So we designed these studies in consultation with the FDA. And one of their questions was okay, if you're able to demonstrate single dose efficacy and that's how we got breakthrough, you'll need to demonstrate that again. And not only for one episode, but continued efficacy over a period whenever it may be used. That's why it is, in fact, double blind. It is double-blind, placebo-controlled for a period of 3 months. So that 3-month period is not open label. And the FDA puts a lot of weight in double-blind placebo-controlled data, thus, we're able to describe the efficacy not just for the first dose, although that is primary, but we're able to describe efficacy and safety whenever it's used as an agitation episode arises. So that is been agreed with FDA. We've agreed on the analysis plan, and that is the data that we'll be presenting to them.

當然。因此，我們在與 FDA 協商後設計了這些研究。他們的一個問題是好的，如果你能夠證明單劑量療效並且這就是我們取得突破的方式，你將需要再次證明這一點。並且不僅針對一次發作，而且在可能使用的一段時間內持續有效。這就是為什麼它實際上是雙盲的。它是雙盲、安慰劑對照的，為期 3 個月。所以說3個月期間是不開標的。 FDA 非常重視雙盲安慰劑對照數據，因此，我們不僅能夠描述第一次劑量的療效，雖然這是主要的，但我們能夠描述療效和安全性它被用作激動事件的出現。因此，這已與 FDA 達成一致。我們已經就分析計劃達成一致，這就是我們將向他們展示的數據。

Got it. One more question I have. This is regarding the adjunctive MDD study. So the Phase I is actually in healthy volunteer. Just curious like what would you like to see at least in how the volunteer that could inform proof of concept for this MDD readout. Thank you.

知道了。我還有一個問題。這是關於輔助 MDD 研究。所以第一階段實際上是在健康的志願者身上。只是好奇，就像您想至少看到志願者如何為這個 MDD 讀出的概念證明提供信息一樣。謝謝。

Yes. So it's true. The study is in healthy volunteers, and it is principally designed to explore safety and tolerability of doses taken on a daily or twice daily basis. So starting with a low dose, it escalates to greater doses and frequency up to twice a day. The highest dose regimen considered acceptably tolerated is tested then in combination with a standard of care serotonin and norepinephrine reuptake inhibitor or SNRI. So we'll describe the development plans in terms of depression after we have that data in hand, we do have advisers who will review that data and our various options for developing in depression. So at this time, we're considering development as an accelerant to the antidepressant response of standard of care, SS and SNRIs. We may choose to test 501's capacity to more rapidly accelerate those patients into response and remission, especially in the first month or so of treatment. These plans will be detailed after we have the data, and we've reviewed this with advisers and literally codified our strategy.

是的。所以這是真的。該研究是在健康志願者中進行的，主要旨在探索每天或每天兩次服用劑量的安全性和耐受性。因此，從低劑量開始，逐漸增加劑量和頻率，每天兩次。然後將被認為可接受耐受的最高劑量方案與護理標準血清素和去甲腎上腺素再攝取抑製劑或 SNRI 組合進行測試。因此，在我們掌握了這些數據之後，我們將根據抑鬱症來描述發展計劃，我們確實有顧問會審查這些數據以及我們在抑鬱症中發展的各種選擇。所以在這個時候，我們正在考慮將發展作為標準護理、SS 和 SNRI 的抗抑鬱反應的促進劑。我們可能會選擇測試 501 更快地加速這些患者進入反應和緩解的能力，尤其是在治療的第一個月左右。這些計劃將在我們獲得數據後詳細說明，我們已經與顧問一起審查了這一點，並從字面上編纂了我們的戰略。

Thank you. Our next questions come from the line of Graig Suvannavejh with Mizuho. Please proceed with your questions.

謝謝。我們的下一個問題來自 Graig Suvannavejh 與 Mizuho 的對話。請繼續回答您的問題。

Hi, good morning. This is Richard on for Graig. And so 2 questions from me is that in SERENITY III, since you're looking for the same efficacy as you have seen so far, in the at-home setting, what is the FDA looking for? Specifically, what are they worried about?

早上好。這是格雷格的理查德。因此，我提出的兩個問題是，在 SERENITY III 中，由於您正在尋找與迄今為止在家庭環境中看到的相同的功效，FDA 在尋找什麼？具體來說，他們擔心什麼？

I don't know that the FDA is worried about anything. We believe we have adequate data. And so we're literally taking that data to the FDA.

我不知道FDA擔心什麼。我們相信我們有足夠的數據。因此，我們實際上是將這些數據提交給 FDA。

So just to add to that, Richard. As Rob mentioned, that purpose of SERENITY is that it can be used broadly for the patients at home. So our goal was to test the efficacious dose, while maintaining the efficacy margin as well as maintaining the safety margin. So 60 dose was very well selected as Rob said, in the trial and agreed with the FDA that this is a dose we want to test. And in a couple of weeks, we will have the data readout. So we will take -- and we are gearing up to start the part 2 of the study with 60 dose can be given and also a second dose patient can take it at home, which is a safety part of the study. So it's very well engineered. It's very thought out, it's agreed with the FDA, and we are excited about upcoming data readouts.

因此，理查德，補充一下。正如 Rob 所提到的，SERENITY 的目的是它可以廣泛用於家中的患者。所以我們的目標是測試有效劑量，同時保持療效邊際和安全邊際。因此，正如 Rob 在試驗中所說，60 劑量的選擇非常好，並同意 FDA 認為這是我們想要測試的劑量。幾週後，我們將讀取數據。所以我們將服用 - 我們正準備開始研究的第 2 部分，可以給予 60 劑，第二劑患者可以在家中服用，這是研究的安全部分。所以它的設計非常好。這是經過深思熟慮的，已與 FDA 達成一致，我們對即將公佈的數據感到興奮。

Okay. Thank you. And one on commercial, Matt this is for you, is I think questions have been asked about what you think about the uptick now. And so I think you've mentioned a metric of your sales force panting 75%. But what do you expect is -- how does that also correlate to uptick from now? And when can we see that uptick?

好的。謝謝。還有一個商業廣告，馬特，這是給你的，我認為有人問過你對現在的上漲有何看法。所以我認為您已經提到了您的銷售人員氣喘吁籲 75% 的指標。但你期望的是 - 這與現在的上漲有何關聯？我們什麼時候可以看到這種上升趨勢？

Yes. So Richard, great question. And that's why we provided the metrics we did this morning, we dollarized what's already been voted upon as well as dollarized the market potential that we can penetrate into with what's scheduled already this year. We expect that most of those votes will happen in Q2 and Q3 that are scheduled, and we'll pick up additional boats and process over the back half of the year to the impact of the additional 44 reps in the field. So I would take that $310 million all in that we have either unlocked or about to unlock. And I would use that uptake curve that's in Slide 25 as a good surrogate as to how that happens. Once we knock down the positive votes and they have the drug in their requisite systems, et cetera, we expect to see similar uptake curves.

是的。所以理查德，很好的問題。這就是為什麼我們提供了今天早上所做的指標，我們將已經投票的內容美元化，並將我們可以滲透到今年已經安排好的市場潛力美元化。我們預計這些投票中的大部分將在計劃的第二季度和第三季度進行，我們將在今年下半年接收更多的船隻並進行處理，以應對該領域額外 44 名代表的影響。因此，我將把這 3.1 億美元全部用於我們已經解鎖或即將解鎖的部分。我會使用幻燈片 25 中的吸收曲線作為一個很好的代理來說明這是如何發生的。一旦我們打倒了贊成票，並且他們的必要係統中有了藥物，等等，我們預計會看到類似的吸收曲線。

And Richard, I would like to add what Matt said, this is Vimal, that our current approval rate is 70% for formulary wins, which is really very exciting. So we are very excited that we will have a lot more formulary wins in next quarter and in second half.

理查德，我想補充一下馬特所說的，這是 Vimal，我們目前的處方獲勝支持率為 70%，這真的非常令人興奮。所以我們很高興我們將在下個季度和下半年獲得更多的公式化勝利。

Great, thank you.

太好了謝謝。

Thank you. Our next questions come from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed with your questions.

謝謝。我們的下一個問題來自 Sumant Kulkarni 與 Canaccord Genuity 的合作。請繼續回答您的問題。

Thanks for taking my questions. Actually all around SERENITY. So the first one, in the at-home use context, how can we tune them is the company to an important fact that in 2015, the FDA approved oral mucosal gel, for at-home use for in dogs and (inaudible) at a strength of 90 micrograms per mil and do you expect an advisory committee meeting for use.

感謝您回答我的問題。實際上到處都是SERENITY。所以第一個，在家庭使用的情況下，我們如何調整它們是公司的一個重要事實，即 2015 年，FDA 批准了口腔粘膜凝膠，用於狗的家庭使用和（聽不清）強度為每密耳 90 微克，您是否希望召開諮詢委員會會議以供使用。

Well, I'll point out that it is, in fact, that same gel is approved for horses, dogs and cats. And we now have a sublingual film approved for humans with schizophrenia and bipolar who are agitated. So we have great confidence in our development program.

好吧，我要指出的是，事實上，同樣的凝膠被批准用於馬、狗和貓。我們現在有一種舌下膜被批准用於患有精神分裂症和躁鬱症的人。所以我們對我們的開發計劃很有信心。

Got it. And then for SERENITY III, how do you approach a scenario where the 60 micrograms strength does not have a statistically significant score and efficacy, but is otherwise safe. I'm asking because the Phase Ib/II study did not hit significance for the 60-microgram dose when you announced the results in July 2019.

知道了。然後對於 SERENITY III，您如何處理 60 微克強度沒有統計顯著分數和功效但在其他方面是安全的情況。我問這個問題是因為當您在 2019 年 7 月宣布結果時，Ib/II 期研究沒有達到 60 微克劑量的顯著性。

So at the end of the day, the regulatory submission will entail both Part 1 for a single dose and Part 2 where we allow that second dose. And I'll just say, although we remain blinded, we have been closely monitoring the overall safety in Part 1 from the single dose, and we are initiating part 2 of the study.

因此，在一天結束時，監管提交將涉及單劑的第 1 部分和我們允許第二劑的第 2 部分。我只想說，雖然我們仍然不知情，但我們一直在密切監測第 1 部分中單劑量的整體安全性，並且我們正在啟動研究的第 2 部分。

And I'll stop a commercial question and a quick one. What time of the year do the bulk of the IDN votes happened?

我將停止一個商業問題和一個快速問題。大部分 IDN 投票發生在一年中的什麼時間？

That depends. I mean the voting schedule is going to be dependent on our engagement when they put it on their schedule to vote. We're seeing them happen now. In fact, we just had a well-known system, relatively small system, but a well-known system and approve us on Friday. And so that was a nice add. And we see this happening every week. And so the cadence of those should continue to improve. We've been engaging with the IDNs ratably since we've launched, and we expect to see more and more of those take place. Remember, we have 70,000 votes or 25% of the targeted IDN beds that are scheduled to vote already. And so we should see even more of those come online as we move throughout the year.

那要看。我的意思是投票時間表將取決於我們在他們將其列入投票時間表時的參與度。我們現在看到它們正在發生。事實上，我們只有一個眾所周知的系統，相對較小的系統，但是一個眾所周知的系統並在星期五批准了我們。所以這是一個很好的補充。我們每週都會看到這種情況發生。因此，這些節奏應該繼續改進。自 IDN 推出以來，我們一直在積極參與，我們希望看到越來越多的此類活動發生。請記住，我們有 70,000 票或 25% 的目標 IDN 床位已計劃進行投票。因此，隨著我們全年的移動，我們應該會看到更多的人上線。

Got it, thanks.

知道了謝謝。

Thank you. Our next questions come from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your questions.

謝謝。我們的下一個問題來自 Ram Selvaraju 和 H.C.溫賴特。請繼續回答您的問題。

Thanks so much for taking my questions. First of all, I just wanted to ask if you expect to maintain reporting of the same commercial metrics going forward? Or if we should expect specific changes? And if so, what those changes might be, just what types of numbers you expect to report going forward? And the second question is with respect to OnkosXcel. Just give us your updated thoughts regarding the strategy there and potential timing of any possible spinout or other equivalent type of transaction. Thank you.

非常感謝你回答我的問題。首先，我只是想問一下，您是否希望在未來繼續報告相同的商業指標？或者我們是否應該期待具體的變化？如果是這樣，這些變化可能是什麼，您希望未來報告哪些類型的數字？第二個問題是關於 OnkosXcel 的。只需向我們提供您對那裡的戰略以及任何可能的分拆或其他等效類型交易的潛在時間的最新想法。謝謝。

So Ram, we do expect to report out the same metrics. We've been consistent since commercial day of last year and reporting on hospitals, formulary and process formulary votes one, and IDN beds in process and IDN beds one. The only difference between those metrics that we reported over the last 2, 3 quarters now. And today is that we've dollarized that opportunity so you can actually see what market we could impact today. And what dollar value we should be able to impact, assuming positive approvals of those in process. So that's the only change. Everything else will stay consistent.

所以 Ram，我們確實希望報告相同的指標。自去年商業日以來，我們一直保持一致，並報告醫院、處方集和流程處方集投票一票，以及處理中的 IDN 床位和 IDN 床位一票。我們在過去 2、3 個季度報告的這些指標之間的唯一區別是現在。今天我們已經將這個機會美元化了，這樣你就可以真正看到我們今天可以影響的市場。以及我們應該能夠影響多少美元價值，假設那些正在處理的人的積極批准。所以這是唯一的變化。其他一切都將保持一致。

Good morning, Ram. This is Vimal. Regarding OnkosXcel, we continue to explore our strategic options. That includes potential financing as well as partnering. So it's an active process, and we are looking forward to providing an update once we have a confirmed position on which direction likely we're going to go.

早上好，拉姆。這是維馬爾。關於 OnkosXcel，我們繼續探索我們的戰略選擇。這包括潛在的融資和合作。所以這是一個積極的過程，一旦我們確定了我們可能要走的方向，我們期待提供更新。

Thank you. There are no further questions at this time. I would now like to hand the call back over to Dr. Mehta for any closing remarks.

謝謝。目前沒有其他問題。我現在想將電話轉回給梅塔博士，聽取任何結束語。

Thank you, everyone, for joining us. And if you have any questions, please feel free to reach out to us, and have a great day.

謝謝大家加入我們。如果您有任何疑問，請隨時與我們聯繫，祝您有美好的一天。

Thank you. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。