Axsome Therapeutics, Inc. (AXSM) 2026 Q2 法說會逐字稿

Good morning, and welcome to the Axsome Therapeutics second quarter 2026 earnings conference call. My name is Kevin, and I'll be your operator for today's call. (Operator Instructions) Please note, this call is being recorded.

早安，歡迎參加 Axsome Therapeutics 2026 年第二季財報電話會議。我是 Kevin，將擔任今天會議的接線員。(接線員指示) 請注意，本通話將被錄音。

I would now like to hand the call over to Ashley Dong, Senior Director of Investor Relations. Please go ahead, Ashley.

現在我想將電話交給投資人關係資深總監 Ashley Dong。Ashley，請開始。

Thank you. Good morning, everyone, and welcome to Axsome's second quarter 2026 Earnings Conference Call. Joining me today to discuss our results for the quarter are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; and Ari Maizel, Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer; and Hunter Murdock, our General Counsel, will also be available for Q&A.

謝謝。各位早安，歡迎參加 Axsome 2026 年第二季財報電話會議。今天與我一同討論本季業績的有：執行長 Herriot Tabuteau 博士；財務長 Nick Pizzie；以及商務長 Ari Maizel，他將以事先準備的發言開場。營運長 Mark Jacobson 與法務長 Hunter Murdock 也將出席並在問答環節提供回應。

Before we begin, I encourage everyone to visit the investors section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance commercial strategy and operational plans, including research, development and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially.

在開始之前，我鼓勵各位造訪我們網站的投資人專區，查閱今日電話會議的新聞稿與簡報。請注意，今天的討論包含關於我們財務表現、商業策略與營運計畫（包括研究、開發與法規活動）的前瞻性陳述。這些陳述係基於目前的預期與假設，並受風險與不確定性影響，可能導致實際結果與所述內容出現重大差異。

Please refer to our SEC filings, including our quarterly and annual reports for a description of these and other risks. You are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements.

請參閱我們向 SEC 提交的文件（包括季度與年度報告），以了解上述及其他風險的說明。敬請注意勿過度依賴這些前瞻性陳述；其僅截至今日為止有效，公司亦不承擔更新此等陳述的任何義務。

And with that, I'll hand it over to Herriot.

接下來，我把時間交給 Herriot。

Thank you, Ashley, and good morning, everyone. The second quarter was highly productive for Axsome as we grew our commercial business robustly and made important regulatory and clinical progress across our innovative neuroscience pipeline. In the second quarter, our commercial portfolio generated $218 million in net product revenue, a 46% increase year-over-year, driven by strong performance for AUVELITY and SUNOSI.

謝謝你，Ashley，各位早安。第二季對 Axsome 而言成果豐碩：我們的商業業務強勁成長，並在創新神經科學產品線上取得重要的法規與臨床進展。第二季，我們的商業產品組合創造了 2.18 億美元的產品淨營收，年增 46%，主要受 AUVELITY 與 SUNOSI 的強勁表現帶動。

In the quarter, we launched AUVELITY in Alzheimer's disease agitation and completed the expansion of the AUVELITY sales force. Early metrics for the sales force expansion in Alzheimer's disease agitation launch point to growth acceleration for AUVELITY.

本季我們在阿茲海默症相關激動（agitation）適應症推出 AUVELITY，並完成 AUVELITY 銷售團隊的擴編。針對阿茲海默症相關激動之上市與銷售團隊擴編的早期指標顯示，AUVELITY 的成長正在加速。

Underlying demand growth for SYMBRAVO is also accelerating, and we expect SUNOSI growth to continue outpacing the market, positioning us for continued strong growth across the entire commercial portfolio. Later in the call, Nick will comment further on our financials, and Ari will provide additional detail on our commercial performance, including early observations in the Alzheimer's disease agitation launch.

SYMBRAVO 的基礎需求成長也在加速，我們預期 SUNOSI 的成長將持續超越市場，讓我們得以在整體商業產品組合上維持強勁成長動能。稍後 Nick 將進一步說明財務狀況，Ari 也將就商業表現提供更多細節，包括在阿茲海默症相關激動上市初期的觀察。

During the quarter, we also advanced our leading neuroscience pipeline of six innovative product candidates, which we are developing for 10 serious conditions. Our broad late-stage neuroscience pipeline positions us to potentially file on average one new NDA each year between now and 2030, delivering potentially significant value to patients and stakeholders. Following Ari's remarks, I'll provide an update on each of these programs.

本季我們也推進了領先的神經科學產品線，包含 6 項創新候選產品，目標用於 10 種嚴重疾病。我們廣泛的後期神經科學產品線，使我們有機會在現在到 2030 年間平均每年提交一件新的 NDA（新藥申請），為病患與利害關係人帶來潛在的重大價值。在 Ari 發言之後，我將逐一更新各項計畫的進展。

With that, I'll turn the call over to Nick.

接下來，我把電話交給 Nick。

Thanks, Herriot. Good morning, everyone. I'll begin with a review of our financial results for the quarter. Revenue increased to $218 million compared to $150 million in Q2 of 2025, representing a 46% year-over-year growth. Performance was driven by AUVELITY with steady growth from SUNOSI and continued strength in prescription demand for SYMBRAVO. We recorded net product sales for AUVELITY of $180.3 million in the quarter, that's a 51% increase compared to the second quarter of 2025 and an 18% increase quarter-over-quarter.

謝謝，Herriot。各位早安。我先回顧本季的財務結果。營收增至 2.18 億美元，較 2025 年第二季的 1.50 億美元成長 46%，年增 46%。表現主要由 AUVELITY 帶動，SUNOSI 穩健成長，且 SYMBRAVO 的處方需求持續強勁。本季 AUVELITY 產品淨銷售額為 1.803 億美元，較 2025 年第二季成長 51%，較上一季成長 18%。

SUNOSI net product revenue for the quarter was $35.8 million, representing a 20% year-over-year growth. SUNOSI revenue consisted of $33.8 million in net product sales, $1.5 million in royalty revenue associated with SUNOSI sales in out-licensed territories and $0.5 million in milestone revenue.

SUNOSI 本季產品淨營收為 3,580 萬美元，年增 20%。SUNOSI 營收包含：3,380 萬美元的產品淨銷售額、與 SUNOSI 在授權外地區銷售相關的 150 萬美元權利金收入，以及 50 萬美元的里程碑收入。

Net sales for SYMBRAVO were $2.3 million in the quarter. SYMBRAVO was launched in June of 2025 and had net product sales of $400,000 for the second quarter of 2025. The decrease of $1.8 million in net sales from Q1 of 2026 primarily reflects a prior period adjustment and increased utilization of our patient service program driven by underlying demand growth.

SYMBRAVO 本季淨銷售額為 230 萬美元。SYMBRAVO 於 2025 年 6 月上市，2025 年第二季產品淨銷售額為 40 萬美元。相較 2026 年第一季淨銷售額減少 180 萬美元，主要反映前期調整，以及在基礎需求成長帶動下，我們病患服務計畫的使用率提高。

As such, SYMBRAVO gross to net discount deviated from trend during the quarter into the high 80% range. We anticipate SYMBRAVO-GTN to return to prior levels for the remainder of the year. Gross net discounts for AUVELITY and SUNOSI were each approximately 50% for the second quarter. We continue to anticipate gross net discount for both products to improve throughout the year, consistent with prior year trends.

因此，SYMBRAVO 的毛額轉淨額（GTN）折扣在本季偏離趨勢，上升至 80% 後段區間。我們預期 SYMBRAVO 的 GTN 將在今年剩餘期間回到先前水準。AUVELITY 與 SUNOSI 在第二季的毛額轉淨額折扣各約為 50%。我們仍預期兩項產品的毛額轉淨額折扣將在今年逐步改善，與前一年度的趨勢一致。

Turning to expenses. Cost of revenue in the quarter was $13.6 million represents 6% of total net revenue. Cost of revenue for the second quarter of 2025 was $13.4 million. Research and development expenses decreased to $46.2 million for the second quarter of 2026 compared to $49.5 million in the second quarter of 2025, which primarily reflects lower costs associated with AXS-05 and AXS-14.

接著談費用。本季營收成本為 1,360 萬美元，占總淨營收的 6%。2025 年第二季營收成本為 1,340 萬美元。2026 年第二季研發費用降至 4,620 萬美元，較 2025 年第二季的 4,950 萬美元下降，主要反映與 AXS-05 與 AXS-14 相關成本較低。

Selling, general and administrative expenses in the quarter were $208.1 million compared to $130.3 million for the second quarter of last year. The increase was primarily driven by commercialization activities for AUVELITY and SYMBRAVO.

本季銷售、一般及行政費用為 2.081 億美元，較去年第二季的 1.303 億美元增加。增加主要由 AUVELITY 與 SYMBRAVO 的商業化活動所帶動。

Finally, net loss for the quarter was $51.3 million or $0.99 per share compared to a net loss of $48 million or $0.97 per share for the second quarter of 2025. Net loss in the quarter includes $27.1 million in stock-based compensation expense.

最後，本季淨損為 5,130 萬美元，或每股淨損 0.99 美元；相較之下，2025 年第二季淨損為 4,800 萬美元，或每股淨損 0.97 美元。本季淨損包含 2,710 萬美元的股份基礎給付費用。

Turning to the balance sheet. We ended the quarter with approximately $320 million in cash and cash equivalents. This compares to $323 million as of end of 2025. As evidenced by this quarter's financial performance, we are seeing continued improvement in operating leverage while investing behind our key commercial opportunities and pipeline priorities. Based on our current operating plan, we continue to expect that our current cash balance is sufficient to fund anticipated operations into cash flow positivity.

接著看資產負債表。本季期末我們持有約 3.20 億美元的現金及約當現金。相較之下，2025 年底為 3.23 億美元。從本季財務表現可見，我們在持續投資於關鍵商業機會與產品線優先事項的同時，營運槓桿也持續改善。依據目前的營運計畫，我們仍預期現有現金餘額足以支應預期營運，直至達成現金流轉正。

Now I'll turn the call over to Ari with a commercial update.

現在我把電話交給 Ari，提供商業面更新。

Thanks, Nick. During the second quarter, we saw strong underlying demand growth across our portfolio of three differentiated medicines. In addition, during the quarter, we further strengthened our commercial foundation positioning us to drive growth across the portfolio over the balance of the year.

謝謝，Nick。第二季期間，我們在由三項具差異化的藥品所構成的產品組合中，看見強勁的基礎需求成長。此外，本季我們也進一步強化商業基礎，使我們能在今年剩餘期間推動整體產品組合的成長。

Beginning with AUVELITY. In the quarter, we launched AUVELITY in the Alzheimer's disease education market and completed the expansion of the AUVELITY sales force. I'm happy to share that early metrics indicate that these two developments are already beginning to have a meaningful impact on demand growth, positioning AUVELITY for continued momentum over the balance of the year.

先從 AUVELITY 開始。本季我們在阿茲海默症教育市場推出 AUVELITY，並完成 AUVELITY 銷售團隊的擴編。我很高興分享，早期指標顯示這兩項進展已開始對需求成長產生顯著影響，使 AUVELITY 在今年剩餘期間可望延續動能。

Regarding Alzheimer's disease agitation, during the first eight weeks following the launch in this indication, new-to-brand prescriptions among patients 65 years of age and older increased 126% compared to the same period in the prior quarter, reflecting expanding adoption in this patient segment. New-to-brand prescriptions represent new patients starting on AUVELITY for the first time and are considered a key leading indicator of growth.

關於阿茲海默症相關激動（agitation），在此適應症上市後的前八週內，65 歲及以上患者的品牌新處方（new-to-brand prescriptions）較前一季同期增加 126%，反映該患者族群的採用度正在擴大。品牌新處方代表首次開始使用 AUVELITY 的新患者，並被視為成長的關鍵領先指標。

While it's early days in the commercialization of AUVELITY and Alzheimer's disease agitation, we are excited by the initial feedback that we have received from prescribers which includes positive anecdotal evidence of AUVELITY's differentiated clinical profile reflected in real-world patient experience.

雖然 AUVELITY 與阿茲海默症相關激動的商業化仍處於早期階段，但我們對處方醫師所提供的初步回饋感到振奮，其中包括正面的軼事性證據，顯示 AUVELITY 具差異化的臨床特性，並在真實世界的患者使用經驗中有所體現。

In particular, providers and care partners alike view the reduction in agitation symptoms and safety and tolerability profile favorably. These early experiences have reinforced our belief that AUVELITY has the potential to transform the treatment paradigm for Alzheimer's disease agitation and we look forward to sharing continued progress in the months ahead.

尤其是，醫療提供者與照護夥伴皆對激動症狀的減輕，以及其安全性與耐受性表現給予正面評價。這些早期經驗強化了我們的信念：AUVELITY 有潛力改變阿茲海默症相關激動的治療典範；我們也期待在未來數月分享持續進展。

We are also beginning to see the early impact of our expanded sales organization with overall new-to-brand prescriptions in the second quarter of 2026, increasing 26% compared to the first quarter of 2026. This momentum has continued into the third quarter.

我們也開始看到擴編銷售組織的早期影響：2026 年第二季整體品牌新處方較 2026 年第一季增加 26%。這股動能已延續至第三季。

In addition to accelerated new patient starts, the expanded sales force activated more than 6,800 new AUVELITY prescribers in the quarter, representing 21% growth versus the previous quarter, bringing the total number of unique prescribers since launch to approximately 69,000.

除新患者啟用加速外，擴編後的銷售團隊在本季啟動了超過 6,800 位新的 AUVELITY 處方醫師，較前一季成長 21%，使自上市以來的獨立處方醫師總數達約 69,000 位。

The inflection in new-to-brand prescriptions and increased velocity of new writer activation are strong leading indicators of our expanded sales force investment and resulted in market share gains for both new-to-brand and total prescriptions in the quarter. We expect these trends to continue to build in Q3 and Q4, translating into positive [TRx] trends and further market share penetration.

品牌新處方的轉折點，以及新開立醫師啟動速度的提升，是我們擴編銷售團隊投資的強勁領先指標，並在本季帶動品牌新處方與總處方的市占率提升。我們預期這些趨勢將在第三季與第四季持續累積，轉化為正向的 [TRx] 趨勢並進一步提升市占滲透率。

Overall, total prescriptions for AUVELITY in the second quarter reached approximately $266,000, an increase of 34% year-over-year and 12% sequentially substantially outpacing the antidepressant market, which grew 1% and 2% in the same time period, respectively.

整體而言，AUVELITY 第二季總處方量約達 266,000 張，年增 34%、季增 12%，顯著優於抗憂鬱藥市場；該市場在相同期間分別成長 1% 與 2%。

In addition, AUVELITY market access continued to improve during the quarter, with coverage now at approximately 89% of total lives across channels, including 82% of commercial lives and approximately 100% of lives in the government channel.

此外，本季 AUVELITY 的市場准入持續改善，目前跨通路的總覆蓋人數（total lives）約達 89%，其中商業保險覆蓋約 82%，政府通路覆蓋約 100%。

Our market access team is working closely with payers in both the commercial and government channels, and we expect patient access for albeit in both the MDD and ABA markets to continue to expand and evolve. Taken together, we expect the momentum from the sales force expansion, continued growth in MDD and uptake in Alzheimer's disease agitation to drive continued growth over the rest of the year.

我們的市場准入團隊正與商業與政府通路的支付方密切合作，我們預期患者可及性（patient access）將在 MDD 與 ABA 兩個市場持續擴大並演進。綜合而言，我們預期銷售團隊擴編帶來的動能、MDD 的持續成長，以及阿茲海默症相關激動的採用提升，將推動今年剩餘期間的持續成長。

For SYMBRAVO, demand was strong, growing 30% quarter-over-quarter to approximately 23,500 total prescriptions. Prescriber and patient feedback continue to be very positive supporting our commercial strategy to drive prescription volume while improving market access to support sustained growth over time. As mentioned on our prior earnings call, based on the strong demand for SYMBRAVO to date, our previously announced sales force expansion to approximately 150 sales representatives is substantially complete.

就 SYMBRAVO 而言，需求強勁，總處方量季增 30% 至約 23,500 張。處方醫師與患者回饋持續非常正面，支持我們的商業策略：在提升處方量的同時改善市場准入，以支撐長期的持續成長。如同我們在上一季法說會所提，基於迄今對 SYMBRAVO 的強勁需求，我們先前宣布將銷售團隊擴編至約 150 名業務代表，目前已大致完成。

Finally, following the previously announced addition of approximately 17 million lives in Q2, overall payer coverage is now at approximately 57% of lives covered across channels, including approximately 56% of commercial lives and 57% of government lives. We expect coverage for SYMBRAVO to further improve moving forward.

最後，在第二季先前宣布新增約 1,700 萬名覆蓋人數後，整體支付方覆蓋目前跨通路約達 57%，其中商業保險覆蓋約 56%，政府通路覆蓋 57%。我們預期 SYMBRAVO 的覆蓋率未來將進一步改善。

SUNOSI delivered another quarter of durable growth with approximately 61,000 total prescriptions written during the quarter representing 14% year-over-year growth and 8% sequential growth compared to a 1% decline and 2% increase for the waste promoting agent market in the same periods, respectively. More than 17,000 clinicians have now prescribed SUNOSI since launch, and we continue to maintain broad payer coverage of approximately 82% of lives covered across all channels.

SUNOSI 本季再度展現穩健成長，季度總處方量約 61,000 張，年增 14%、季增 8%；相較之下，促醒劑（wake promoting agent）市場在相同期間分別下滑 1% 與成長 2%。自上市以來，已有超過 17,000 位臨床醫師開立 SUNOSI，我們也持續維持跨所有通路約 82% 覆蓋人數的廣泛支付方覆蓋。

Overall, the underlying commercial performance in Q2 reflects positive momentum for Axsome's portfolio of differentiated CNS products. Acceleration of AUVELITY in MDD and Alzheimer's disease education continued market penetration for SYMBRAVO and migraine and consistent growth from SUNOSI and EDS associated with narcolepsy and OSA position Axsome for a strong second half of 2026 and robust growth in the years ahead.

整體而言，第二季的核心商業表現反映 Axsome 具差異化的中樞神經系統（CNS）產品組合正展現正向動能。AUVELITY 在 MDD 與阿茲海默症相關激動的加速成長、SYMBRAVO 在偏頭痛領域的持續市場滲透，以及 SUNOSI 與與嗜睡症及 OSA 相關之 EDS 的穩定成長，使 Axsome 有望在 2026 年下半年表現強勁，並在未來數年實現穩健成長。

I will now turn the call back to Herriot.

我現在把電話交回給 Herriot。

Thank you, Ari. We are excited by our innovative neuroscience pipeline, which targets high unmet medical needs, novel indications first-in-class mechanisms of action and best-in-class profiles. I'll now review the recent pipeline progress and discuss key upcoming clinical and regulatory milestones.

謝謝你，Ari。我們對創新的神經科學研發管線感到振奮；該管線聚焦於高度未被滿足的醫療需求、新穎適應症、同類首創（first-in-class）的作用機轉，以及同類最佳（best-in-class）的特性。接下來我將回顧近期研發管線進展，並討論即將到來的關鍵臨床與法規里程碑。

In the quarter, the FDA accepted our NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy with a PDUFA target action date of May 1, 2027. Based on its differentiated mechanism of action and resulting clinical profile, AXS-12 has the potential to provide a meaningful addition to the treatment armamentarium for patients living with narcolepsy if approved.

本季，FDA 已受理我們針對 AXS-12 用於治療嗜睡症之猝倒（cataplexy）的 NDA 申請，PDUFA 目標審查行動日期為 2027 年 5 月 1 日。基於其差異化的作用機轉及由此帶來的臨床特性，若獲核准，AXS-12 有潛力為嗜睡症患者的治療工具箱提供具意義的新增選項。

For AXS-05, the next indication under development is smoking cessation. We are on track to initiate our planned Phase 2/3 trial in this indication this quarter. Exploring the full clinical potential of AXS-05 remains a top priority for us based on its unique pharmacology, which is potentially applicable across multiple neuropsychiatric disorders.

就 AXS-05 而言，下一個開發中的適應症為戒菸。我們按計畫將於本季啟動此適應症的第二/三期試驗。基於其獨特藥理特性，且可能適用於多種神經精神疾病，我們持續將探索 AXS-05 的完整臨床潛力列為首要優先事項。

Solriamfetol, our clinical programs across four new indications continue to advance. As a reminder, the new indications being explored are ADHD, binge-eating disorder, MDD with excessive daytime sleepiness or EDS symptoms and EDS associated with shift work disorder. All in all, we currently have five Phase 3 trials underway across these indications.

Solriamfetol 方面，我們在四個新適應症的臨床計畫持續推進。提醒一下，正在探索的新適應症包括 ADHD、暴食症（binge-eating disorder）、伴隨過度日間嗜睡或 EDS 症狀的 MDD，以及與輪班工作障礙（shift work disorder）相關的 EDS。總體而言，我們目前在這些適應症上共有五項第三期試驗正在進行。

In ADHD, we recently initiated the FOCUS-2 and FOCUS-3 studies of solriamfetol in children and adolescents with ADHD. These studies use a parallel group design with a primary endpoint of change from baseline to week six in the ADHD rating scale. These two studies if positive, together with the previously completed positive FOCUS Phase 3 trial of solriamfetol in adults would form the basis of an NDA filing for solriamfetol in the treatment of ADHD.

在 ADHD 方面，我們近期已啟動 solriamfetol 用於 ADHD 兒童與青少年的 FOCUS-2 與 FOCUS-3 研究。這些研究採平行組設計，主要終點為 ADHD 評分量表從基線至第六週的變化。若這兩項研究結果為正向，並結合先前已完成且結果正向的 solriamfetol 成人 ADHD FOCUS 第三期試驗，將構成 solriamfetol 用於治療 ADHD 的 NDA 申請基礎。

In binge eating disorder, our ENGAGE Phase 3 trial continues to enroll, and we anticipate top line results from the study in the fourth quarter of this year. Our CLARITY Phase 3 trial of solriamfetol in MDD with ADS. Our SUSTAIN Phase 3 trial soloinfetol, [NEDS] associated with the shift work disorder are also advancing.

在暴食症方面，我們的 ENGAGE 第三期試驗持續收案，並預期於今年第四季取得該研究的主要結果（top line results）。我們針對 solriamfetol 用於伴隨 ADS 的 MDD 之 CLARITY 第三期試驗。我們的 SUSTAIN 第三期試驗 soloinfetol、與輪班工作障礙相關的 [NEDS] 也在推進中。

For AXS-14, which we are developing for fibromyalgia enrollment in our FORWARD Phase 3 trial continues to progress. The FORWARD trial, if positive, together with the previously completed positive Phase 2 and Phase 3 trials would support an NDA filing for AXS-14 for the treatment of fibromyalgia.

就 AXS-14 而言，我們正將其開發用於纖維肌痛症（fibromyalgia），FORWARD 第三期試驗的收案持續推進。若 FORWARD 試驗結果為正向，並結合先前已完成且結果正向的第二期與第三期試驗，將可支持 AXS-14 用於治療纖維肌痛症的 NDA 申請。

With AXS-20, our first-in-class selective PDE10A inhibitor, we are making good progress in our chemistry, manufacturing and controls activities with the goal of initiating a Phase 3 trial with this molecule in schizophrenia. We are also advancing Phase 2 enabling activities for AXS-17, our GABA subtype selective PAM, which we are developing for epilepsy.

就 AXS-20（同類首創的選擇性 PDE10A 抑制劑）而言，我們在化學、製造與管制（CMC）活動方面進展良好，目標是以此分子在思覺失調症（schizophrenia）啟動第三期試驗。我們也在推進 AXS-17 的第二期前置（enabling）活動；AXS-17 為我們的 GABA 亞型選擇性正向變構調節劑（PAM），正開發用於癲癇。

In summary, we are excited by the programs in our leading neuroscience pipeline. Combined with building momentum in our existing commercial business, these programs targeting areas of unmet medical need lay the groundwork for continued growth and value creation for patients and stakeholders.

總結來說，我們對於我們領先的神經科學研發管線中的各項計畫感到振奮。結合我們既有商業業務持續累積的動能，這些鎖定未被滿足醫療需求領域的計畫，為持續成長以及為病患與利害關係人創造價值奠定基礎。

I will now turn the call back to Ashley.

我現在把電話交回給 Ashley。

Thanks, Herriot. This concludes our prepared remarks, and we'll now begin the Q&A session. To allow enough time for as many questions as possible, we kindly ask that you limit yourself to one question. Operator, please open the line.

謝謝你，Herriot。我們的預先準備發言到此結束，接下來開始問答環節。為了讓時間足夠回答盡可能多的問題，敬請每位提問者限制為一個問題。接線員，請開放線路。

(Operator Instructions)

(接線員指示)

Leonid Timashev, RBC Capital Markets.

Leonid Timashev，RBC Capital Markets。

Just one maybe on the Alzheimer's agitation launch, specifically as it relates to long-term care I guess, can you talk about the trends that you're seeing in the long-term care, I guess, the enthusiasm there? And then given that it's a new area that you're launching into sort of any successes or challenges that you're seeing there?

我可能只有一個問題，關於阿茲海默症躁動（agitation）的上市推廣，特別是與長期照護相關的部分。你們能談談在長期照護（LTC）方面看到的趨勢、以及那邊的熱度/接受度嗎？另外，鑑於這是你們正在切入的新領域，你們在那裡看到哪些成功之處或挑戰？

Thanks, Leo, for the question. As we stated on the -- earlier on the call, we're just eight weeks into the launch. We're really encouraged by some of the early data we're seeing, the early patient experience has been very promising. We're seeing strong growth in new-to-brand prescriptions in patients aged 65 and older. And that feedback is consistent from both the community and long-term care settings.

謝謝你，Leo，這個問題。如同我們在電話會議前面提到的，我們上市推廣才進行了八週。我們對目前看到的一些早期數據非常受到鼓舞，早期病患使用經驗相當令人期待。我們看到在 65 歲以上病患中，新用戶處方（new-to-brand prescriptions）呈現強勁成長。而且這些回饋在社區端與長期照護機構端都一致。

So obviously, as we get further into the launch, we'll be able to share some additional details around specific settings of care, but we've been really encouraged by what we're seeing across both LTC and community.

所以很明顯地，隨著上市推廣進一步推進，我們將能分享更多關於特定照護場域的細節；但目前我們對於在 LTC 與社區端兩邊所看到的情況都非常受到鼓舞。

Malcolm Hoffman, BMO Capital Markets.

Malcolm Hoffman，BMO Capital Markets。

You highlighted some pretty strong growth in NBRx for AUVELITY and the 65-plus patient group there. Can you maybe break this out further to indicate how much of this may be driven by agitation versus MDD expansion as well?

你們提到 AUVELITY 的新品牌處方（NBRx）以及 65 歲以上病患族群有相當強勁的成長。你們能否再進一步拆解，說明其中有多少可能是由躁動適應症帶動、以及有多少也來自 MDD（重度憂鬱症）擴張？

Yes. Thanks so much for the question. As we mentioned on the call, NBRx growth was very positive, 26% versus Q1. We are seeing meaningful increases in both MDD and Alzheimer's disease agitation, which we would expect to continue moving forward.

可以。非常感謝你的問題。如同我們在會議中提到的，NBRx 成長非常正向，較第一季成長 26%。我們看到 MDD 與阿茲海默症躁動兩個領域都有顯著增加，我們也預期未來會持續推進。

Ash Verma, UBS.

Ash Verma，UBS。

Congrats on the progress here. Maybe just on like Alzheimer's agitation. Can you talk about the level of sampling that you need to do early in the launch. And as the time progresses, would that gradually be lower -- is this sampling going to be more or less than the MDD launch that you did? Just help us understand so that we can correlate to data that we are seeing at our and other third-party sources.

恭喜你們在這裡的進展。我想問一下阿茲海默症躁動這塊。你們能談談在上市初期需要進行的試用品（sampling）規模嗎？隨著時間推進，這個試用品投放會逐步降低嗎——相較於你們先前做的 MDD 上市推廣，這次的 sampling 會更多還是更少？請協助我們理解，以便我們能與我們及其他第三方來源看到的數據做對照。

Yes. As it relates to sampling, particularly in the community setting, sampling is important to gain trial with patients, and we've been committed as an organization to ensure that patients are appropriately titrated based on the approved dosage and administration. I think it's a little too early for us to indicate how sampling will change over time.

好的。就試用品而言，特別是在社區端的場域，試用品對於讓病患嘗試用藥很重要；而且我們作為一個組織也一直致力於確保病患依照核准的劑量與用法用量進行適當的滴定（titration）。我認為現在要判斷試用品策略會如何隨時間改變，還稍微太早。

But right now, we're very pleased with the strong demand for samples and it's been applauded by the clinical community in order to get patients started effectively and to give them the best chance for the clinical profile that we saw in our Phase 3 clinical trials.

但就目前而言，我們對試用品的強勁需求感到非常滿意；臨床社群也對此表示肯定，因為這有助於讓病患有效開始治療，並讓他們有最佳機會達到我們在第三期臨床試驗中看到的臨床表現。

Rudy Li, Wolfe Research.

Rudy Li，Wolfe Research。

For ADA, can you provide more color on the capital rate of like IQVIA of the prescription data for the titration package and what additional key commercial metrics you'll be monitoring to track the progress?

針對 ADA，你們能否就 IQVIA 處方數據中滴定包（titration package）的擷取率（capture rate）提供更多說明？以及你們還會監測哪些關鍵商業指標來追蹤進展？

Yes. I would say on the capture rate for the titration pack specifically, there's really limited data. So we'll learn more as we get further into the launch. In terms of ongoing performance data, I think obviously, sharing information about adoption or utilization with patients who are 65 years and older was an important signal for this particular call. And as we get more data into the launch, I think we'll update based on the most relevant trends related to the launch.

可以。我會說，就滴定包的擷取率而言，目前可用數據其實非常有限。因此我們會在上市推廣更往後推進時學到更多。就持續性的績效數據而言，我想很明顯地，分享 65 歲以上病患的採用或使用情況，是本次電話會議的一個重要訊號。隨著上市推廣累積更多數據，我們會根據與上市最相關的趨勢提供更新。

Marc Goodman, Leerink Partners.

Marc Goodman，Leerink Partners。

Nick, can you talk about where you think AUVELITY gross to nets will settle out in, let's say, two years after both of these indications or kind of going? And just for depression alone, what first line, second line, what percentage are we up to now?

Nick，你能談談你認為 AUVELITY 的毛到淨（gross-to-net）在例如兩年後、當這兩個適應症都推進一段時間後，會落在什麼水準嗎？另外，就憂鬱症單一適應症而言，目前第一線、第二線使用的占比大概到多少了？

Sure. Marc, so maybe first, where we were for the LD and GTN for -- this quarter, we were around 50%, as I shared in the opening remarks, that's obviously with the increase in covered lives and also with improving the quality of coverage to the first-line or for switch.

當然。Marc，所以也許先談一下本季的清單折扣（LD）與毛到淨（GTN）——如同我在開場致詞中分享的，本季大約在 50% 左右；這顯然反映了涵蓋人數（covered lives）的增加，以及保險給付品質改善到第一線或轉換用藥（switch）的層級。

As you alluded to in a couple of years, we anticipate Medicare scripts to become a higher proportion of scripts compared to commercial. What we've shared longer term is that we would anticipate GTN to remain in the 50s. And we'll be able to give better guidance probably towards the end of the year as we see this launch grow in ADA.

如你提到的，幾年後我們預期 Medicare 處方在整體處方中的占比會相對於商業保險更高。我們長期以來分享的看法是，預期 GTN 會維持在 50% 多的區間。隨著 ADA 的上市推廣成長，我們大概能在年底提供更好的指引。

Yes. And as it relates to first, second line use in this quarter, we saw about more than half of the patients, 56% were treated in the first- or second-line setting. As we've shared previously, we don't have a particular percentage in mind.

是的。至於本季第一線、第二線的使用情況，我們看到超過一半的病患——56%——是在第一線或第二線的情境下接受治療。如同我們先前分享的，我們並沒有設定特定的目標百分比。

We know that AUVELITY has been effective in patients as early as treatment naive and its latest as treatment experience. And so we're very comfortable with what we've seen over the past few years, and it's certainly supporting continued growth in both MDD and Alzheimer's agitation.

我們知道 AUVELITY 對於從治療新手（treatment naive）到已有治療經驗的病患都有效。因此我們對過去幾年所看到的結果非常有信心，而這也確實支持 MDD 與阿茲海默症躁動兩個領域的持續成長。

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

Maybe if you can talk about some of the market dynamics with SYMBRAVO and talk about the evolution of the adoption rate there and how do you see that progressing over the coming months?

你們是否可以談談 SYMBRAVO 的一些市場動態，並說明那邊採用率（adoption rate）的演變，以及你們如何看待未來幾個月的進展？

Yes. Thanks for the question. I mean we're very pleased with the underlying demand for SYMBRAVO. As we stated earlier, it grew 30% versus Q1 and we're receiving very positive feedback from both patients and providers around SYMBRAVO's clinical profile and impact on patients.

好的。謝謝你的問題。我們對 SYMBRAVO 的基本需求（underlying demand）非常滿意。如同我們先前提到的，它較第一季成長 30%，而且我們從病患與醫療提供者（providers）兩端都收到非常正面的回饋，認為 SYMBRAVO 的臨床特性以及對病患的影響都很出色。

We expect that to continue. We mentioned that our sales force is expanding to approximately 150 sales representatives. That will enable us not only to call on higher decile headache specialists with more frequency but also continue to expand and penetrate the primary care setting, which has been key source of growth over the past several quarters.

我們預期這樣的趨勢會持續。我們也提到，我們的業務團隊將擴編至約 150 位業務代表。這不僅能讓我們更頻繁地拜訪高十分位（higher decile）的頭痛專科醫師，也能持續擴大並深入基層醫療（primary care）場域；而基層醫療在過去幾個季度一直是成長的關鍵來源。

Andrew Tsai, Jefferies.

Andrew Tsai，Jefferies。

Congrats on the quarter. This is Matt Barcus on for Andrew Tsai. I just wanted to ask, can you confirm what the exact percentage of your Alzheimer's agitation scrips or samples right now? And then since samples tend to run out in two to three weeks, any patient in June, July, a sample should be converting to a national patient by now, you think?

恭喜本季表現。我是代替 Andrew Tsai 提問的 Matt Barcus。我想請問，你們能否確認目前你們阿茲海默症躁動處方（scrips）或試用品（samples）的確切百分比是多少？另外，由於試用品通常在兩到三週內用完，六月、七月拿到試用品的病患，照理說現在應該已經轉為正式付費病患（national patient）了，你們認為是這樣嗎？

So is the total AUVELITY weekly script growth in the last couple of weeks, representative of the weekly growth profile that could be going forward? Or would you absolutely expect a faster cadence in August and September compared to June and July?

那麼，過去幾週 AUVELITY 每週處方量的總成長，是否代表未來可能延續的每週成長曲線？或者您是否絕對預期 8 月與 9 月的成長節奏會比 6 月與 7 月更快？

Yes. Thanks for the question. We don't share specific details regarding sampling as a proportion of overall demand. But we've been very pleased with the overall demand for samples in the community setting. And again, I think that, that's a very important aspect of the launch to support effective titration for elderly patients. In terms of weekly growth, as we mentioned, we've got 8 weeks of data that we're sharing today. We expect to learn much more in the coming months related to the launch, but we've been very pleased with the early indicators.

是的。謝謝你的提問。我們不會分享關於試用樣品占整體需求比例的具體細節。但我們對於社區端對樣品的整體需求感到非常滿意。而且再次強調，我認為這是上市推廣中非常重要的一環，有助於支持高齡患者進行有效的劑量滴定。就每週成長而言，如我們提到的，我們今天分享的是 8 週的數據。我們預期在接下來幾個月會對上市推進有更多學習，但我們對早期指標感到非常滿意。

Pete Stavropoulos, Cantor Fitzgerald.

Pete Stavropoulos，Cantor Fitzgerald。

Congrats on the quarter. For AXS-12 reboxetine, there was the first approval of an orexin two receptor agonist last week. How do you think about the underlying commercial opportunity for reboxetine in the neurocolelpepsy market that has this new class of drug approved. Also, have you had discussions with payers around the profile of AXS-12 and possible pricing?

恭喜本季表現。關於 AXS-12 reboxetine，上週首個食慾素雙受體致效劑獲得核准。在這個新藥物類別已獲核准的情況下，您如何看待 reboxetine 在嗜睡症市場的潛在商業機會？另外，您是否已與付款方就 AXS-12 的產品特性以及可能的定價進行討論？

Great. Thanks for the question. I'll take the first part of that question, and Ari can take the second part. If you look at the narcolepsy market, we know that it is characterized by a lot of heterogeneity in the narcolepsy patient population. So more treatments are better for patients.

好的。謝謝你的提問。我先回答問題的第一部分，第二部分 Ari 可以回答。如果你看嗜睡症市場，我們知道嗜睡症患者族群具有高度異質性。因此，對患者而言，治療選項越多越好。

We're excited by the potential for AXS-12 to provide a new and differentiated treatment option for patients living with narcolepsy. If you think about it mechanistically, it works on the orexin pathway. Orexin stimulates the local cereals to produce norepinephrine and AXS-12 also stimulates norepinephrine production.

我們對 AXS-12 有潛力為嗜睡症患者提供一個全新且具差異化的治療選項感到振奮。從作用機轉來看，它作用於食慾素（orexin）途徑。食慾素會刺激局部神經元產生去甲腎上腺素，而 AXS-12 也會刺激去甲腎上腺素的生成。

What we like about AXS-12 clinically or a few things. One, it works very quickly. We have onset of action, which is demonstrated at 1 week.

我們在臨床上喜歡 AXS-12 的地方有幾點。第一，它起效非常快。我們看到的起效時間在 1 週即可證實。

Secondly, the efficacy is durable. We have data out to 6 months. And if you look at the side effect profile, it is very favorable. You combine that with a first-in-class mechanism interaction for narcolepsy. And also, you look at the clinical data, which shows that there is the potential to affect EDS as well as cognition. So we're very excited by the potential to provide a new treatment option for patients, and we think that, that will be welcome in the marketplace.

第二，療效具有持久性。我們有長達 6 個月的數據。而如果你看副作用特性，它非常有利。再加上其在嗜睡症上屬於同類首創的機轉互動。同時，臨床數據顯示它可能影響日間過度嗜睡（EDS）以及認知。因此我們對其提供新的治療選項的潛力感到非常興奮，也認為市場會樂於接受。

Yes. And regarding your question about market access, we've had very productive conversations with payers as they're learning more about AXS-12. And obviously, there's a lot of interest in narcolepsy. We won't comment on pricing until closer to the launch. But we feel very optimistic about the potential for patient access for AXS-12.

是的。至於你關於市場准入的問題，隨著付款方對 AXS-12 了解加深，我們已與他們進行了非常有成效的對話。而且顯然，嗜睡症領域有很高的關注度。我們在更接近上市時才會評論定價。但我們對 AXS-12 的患者可及性潛力感到非常樂觀。

Ram Selvaraju, HC Wainwright.

Ram Selvaraju，HC Wainwright。

Just wanted to see how you're thinking about the relative positioning of balipodect in schizophrenia. And if you are thinking about specific treatment combinations positioning as adjunct treatment versus stand-alone and what the prospects are for applicability of this drug in neuropsych indications beyond schizophrenia down the road?

想請教你們如何看待 balipodect 在思覺失調症中的相對定位。以及你們是否在考慮特定的治療組合定位，例如作為輔助治療（adjunct）相對於單藥治療（stand-alone）；另外，未來這個藥物在思覺失調症以外的神經精神適應症上的應用前景如何？

Sure. Thanks, Ram, for the question. We're really excited by the prospects for balipodect in schizophrenia. Right now, what we're doing is we are conducting chemistry manufacturing controlled activities to at able the start of a Phase 3 trial in schizophrenia. So stay tuned. That work is well underway, and that is a priority for that program.

當然。謝謝你，Ram，提出這個問題。我們對 balipodect 在思覺失調症的前景感到非常振奮。目前我們正在進行化學、製造與管制（CMC）相關工作，以便啟動思覺失調症的第 3 期試驗。敬請期待。這項工作進展順利，且是該專案的優先事項。

Other indications that we're looking at or Tourette's syndrome. So we've stated that we do intend to initiate a Phase 3 trial -- a Phase 2 trial in that indication also. So that molecule and the clinical programs are progressing. As it relates to how it would be used either as monotherapy or with other products, it's too early. We want to do the experiment, and that's the Phase 3 trial.

我們也在評估的其他適應症包括妥瑞氏症。我們已表示確實打算在該適應症啟動一項第 2 期試驗。因此，該分子與臨床計畫都在推進中。至於未來會作為單藥使用或與其他產品合併使用，現在還太早。我們希望透過試驗來驗證，而那就是第 3 期試驗要做的事。

We are encouraged by the results of the Phase 2 trial, which was conducted in this patient population, which showed a very significant treatment effect if you look at a product as well as a favorable side effect profile, which dovetails very nicely with the unique mechanism of action of the product.

我們受到第 2 期試驗結果的鼓舞；該試驗在這個患者族群中進行，若你看療效，顯示非常顯著的治療效果，同時副作用特性也相當有利，這與該產品獨特的作用機轉非常契合。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So on AD agitation, and I know these are early days, but do you have a good read regarding how the drug is being used relative to reuptake inhibitors. Are you seeing usage in frontline or downstream of reuptake inhibitors that historically have been used off-label in AD agitation or maybe a mix of both? Just wondering if you have a sense of where the usage mix is falling again in these early days.

關於阿茲海默症（AD）躁動，我知道目前還是早期階段，但你們是否已能較清楚掌握該藥物相對於再攝取抑制劑的使用情況？你們看到的是作為第一線使用，還是多在再攝取抑制劑之後使用？這些藥物過去常被以超適應症方式用於 AD 躁動；或是兩者混合？只是想了解在這個早期階段，你們是否對使用組合的分布已有概念。

Yes. Thanks for the question, David. I think the data is limited at this point regarding where patients are coming from, if they're switching from SSRIs, SNRIs, atypical antipsychotic and the line of treatment, we'll learn more as the launch progresses.

是的。謝謝你的提問，David。我認為目前關於患者來源的數據仍有限，例如是否從 SSRI、SNRI、非典型抗精神病藥轉換而來，以及所處的治療線別；隨著上市推進，我們會學到更多。

But I would say, in general, the anecdotal feedback we're getting is that the drug is working per the label, meaning that we're seeing rapid onset of action, a reduction in both the severity and frequency of symptoms and the safety tolerability profile has been viewed favorably by both HCPs and care partners alike.

但我會說，整體而言，我們收到的軼聞回饋是該藥物的表現符合標籤所述，也就是我們看到快速起效、症狀嚴重度與發作頻率皆下降，而且其安全性與耐受性特性也受到醫療專業人員（HCP）與照護夥伴的正面評價。

So I think we'll learn more in the coming weeks and months about line of usage and where the patients are coming from. But we're very pleased with the early response we're hearing.

因此，我想在接下來幾週與幾個月，我們會更了解使用線別以及患者來源。但我們對目前聽到的早期反應感到非常滿意。

Jason Gerberry, Bank of America.

Jason Gerberry，美國銀行（Bank of America）。

Mine -- so it sounds like some impressive physician or prescriber expansion metrics, I think, plus 6,500, I think I heard. That I guess, breadth of prescriber expansion, how much of that is just neurologists, someone who's maybe more of a unique prescriber to ADA versus, say, primary care type of prescriber that might be prescribing ability across both indications.

我這邊——聽起來你們在醫師或開立處方者擴張的指標上相當亮眼，我想我聽到的是增加 6,500 位。就這個開方者擴張的廣度而言，其中有多少只是神經科醫師——也就是可能更偏向 ADA 的特定開方者——相較於例如基層醫療（primary care）類型的開方者，後者可能在兩個適應症上都有開立能力？

I don't know if you have a sense of -- as you're seeing that prescriber base expand, if it's more just breaking into the newer prescribers unique for ADA or if you're getting prescribers who could potentially drive growth in both indications.

我不確定你們是否有概念——隨著開方者基礎擴大，這是否主要是打入 ADA 特有的新開方者，或是你們也正在獲得可能同時帶動兩個適應症成長的開方者？

Yes. Thanks, Jason. I think for the Q2 data, it's largely related to our sales force expansion. And we're very pleased with those early signals as it relates to new writer activation, obviously, NBRx or new-to-brand prescription growth which largely is coming from the sales force expansion and predominantly from growth within the MDD indication.

是的。謝謝你，Jason。我認為就第二季（Q2）數據而言，主要與我們擴編銷售團隊有關。而就新開方者啟動而言，我們對這些早期訊號感到非常滿意；顯然，NBRx（新品牌處方）或新轉入品牌處方的成長，主要來自銷售團隊擴編，且主要是來自 MDD 適應症的成長。

So for this particular quarter, I would say neuros may not be representative necessarily Primary care is the predominant growth driver within Q2 data specifically.

就本季而言，我會說神經科醫師的情況未必具有代表性；在Q2數據中，基層醫療（Primary Care）是主要的成長驅動因素。

Obviously, as the launch progresses in Alzheimer's agitation, we would expect to see more specialists adopt. But for this particular quarter, I would say that really nice growth in the site specialties, but faster growth within primary care.

顯然，隨著阿茲海默症躁動適應症的上市推進，我們預期會看到更多專科醫師採用。但就本季而言，我會說各站點專科別的成長相當不錯，但基層醫療的成長更快。

Sean Laaman, Morgan Stanley Investment Management.

Sean Laaman，Morgan Stanley Investment Management。

Just thinking to your peak revenue assumptions for AUVELITY, which of these would have the greatest impact among prescriber activation, long-term care penetration, treatment duration, payer access and market expansion into previously untreated patients, which has the greatest sensitivity.

我在想你們對AUVELITY的峰值營收假設：在處方醫師啟動、長期照護滲透率、治療期間、支付方給付可近性，以及市場擴張至先前未治療患者之間，哪一項影響最大、敏感度最高？

Yes. Thanks for the question. I think all of those things are important. Obviously, we'll be focused on all aspects, and accelerating new rider activation, I think new-to-brand prescriptions are a really important leading indicator of long-term growth potential. That's a key area of focus.

是的。謝謝你的問題。我認為這些因素都很重要。顯然，我們會聚焦於各個面向，而加速新開立者（new writer）的啟動，我認為新品牌處方（new-to-brand prescriptions）是長期成長潛力非常重要的領先指標。這是我們重點關注的領域。

As we've demonstrated our ability to expand market access and payer coverage for our brands has also been very positive. So I would say it's difficult to pick just one of the elements that you're describing. But we -- from a commercial perspective, we're focused on improving execution across the board.

此外，我們已證明有能力為我們的品牌擴大市場可近性與支付方給付覆蓋，這也非常正面。所以我會說，很難只挑你所描述的其中一個要素。但從商業角度來看，我們專注於全面提升各方面的執行力。

Brian Skorney, Baird.

Brian Skorney，Baird。

I was hoping you did help us think through a little more on the sampling impact in the early days of the Alzheimer's agitation launch. Are these free samples at point of care? Is this primarily a coupon card that's issued at point of care or online and turned in at the pharmacy that covers the full cost of treatment. Just trying to think would it be reasonable to assume most of the NBRxs in Alzheimer's agitation right now are free samples.

我希望你們能協助我們更深入思考一下，在阿茲海默症躁動上市初期，試用裝（sampling）的影響。這些是於照護現場提供的免費試用裝嗎？還是主要是在照護現場或線上發放、到藥局兌換、可涵蓋完整療程費用的折價卡（coupon card）？我只是想釐清：是否可以合理假設，目前阿茲海默症躁動的多數新品牌處方（NBRx）其實是免費試用裝。

And for a Medicare patient, would the goal be to have them on commercial at the first refill, like do you see sampling as a bridge to securing best coverage for the patient? Or is it to getting over initial abandonment of the new prescription over the co-pay.

另外，對於Medicare病患，目標是否是在第一次續配時讓他們轉到商業保險（commercial）給付？也就是說，你們是否把試用裝視為協助病患取得最佳給付的過渡橋樑？或者其目的在於降低因自付額（co-pay）而導致新處方一開始就放棄領藥（abandonment）的情況？

Yes. Thanks for the question, Brian. Sampling, when we relate -- refer to sampling, we're primarily talking about free samples trial offer that is provided to community-based settings where the clinicians are able to give a sample to a patient or care partner during an office visit. It's an important aspect of any launch in order to encourage trial and to really give early patient experience with the product.

是的。謝謝你的問題，Brian。我們提到的試用裝（sampling），主要是指提供給社區型醫療場域的免費試用方案，讓臨床醫師能在門診就診時，將試用裝交給病患或照護夥伴。這是任何產品上市的重要環節，用以鼓勵試用，並讓早期病患實際體驗產品。

As you can imagine, in the Alzheimer's population, there's a heightened sensitivity just to the patients and safety tolerability aspects. So this gives them a chance to see how the drug performs in advance of a first prescription.

如你所想像，在阿茲海默症族群中，對病患以及安全性與耐受性面向的敏感度更高。因此，這讓他們有機會在開立第一張處方之前，先觀察藥物的表現。

We expect to continue to sample as appropriate. It's been applauded by the clinician community primarily because it allows the patient to go home with the titration doses in order to get up to a steady state on the maintenance dose when they're home.

我們預期會在適當情況下持續提供試用裝。臨床醫師社群對此多所肯定，主要因為這讓病患能帶著滴定（titration）劑量回家，以便在家中逐步調整至維持劑量的穩態（steady state）。

So I think we'll have more to share down the road as we see more data related to sample conversion. But I would just say that samples are not prescriptions, so they're not showing up in the IQVIA data. that's an important factor as you think about it.

因此，我想隨著我們看到更多與試用裝轉換（sample conversion）相關的數據，之後會有更多可以分享。但我想強調，試用裝不是處方，因此不會出現在IQVIA數據中；在你思考這點時，這是一個重要因素。

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Maybe on binge eating disorder. Can you comment on the clinically meaningful result that you're looking for later this year on reduction in episodes? Or is it just that sign placebo response and binge eating disorder studies can sometimes be reasonably high, especially if the patient population maybe isn't severe enough. So can you comment on your overall level of comfort with the patient population that you did enroll in this trial?

或許談談暴食症（binge eating disorder）。你們能否評論一下，今年稍晚你們在「發作次數降低」方面所期待的具臨床意義結果？或者只是因為暴食症研究中的安慰劑反應有時可能相當高，尤其若病患族群的嚴重度不夠。所以你們能否談談，對於本試驗所納入病患族群，你們整體的信心程度？

We're very comfortable with the patient population. We think that we designed a study and we were enrolling patients that are appropriate to be studied in the clinical trial in binge eating disorder. As it relates to BOEs, we don't have any. So we designed a study. We powered it for statistical significance, and that's what we're looking for.

我們對病患族群非常有信心。我們認為研究設計得當，且所納入的病患適合在暴食症的臨床試驗中進行研究。至於BOE，我們沒有任何（可補充的資訊）。因此我們設計了這項研究。我們以達到統計顯著性為目標進行樣本數估算（powered），而這就是我們所要追求的。

Ben Burnett, Wells Fargo.

Ben Burnett，Wells Fargo。

I also wanted to ask about AUVELITY and the new-to-brand growth rate that you mentioned, 26% quarter-over-quarter. Just wanted to see if we could get maybe a little bit more context for this number? Like how does this number compare to the prior period in Q1? And just based on what you're seeing, what kind of growth should we sort of be thinking about in Q3?

我也想問AUVELITY，以及你提到的新品牌成長率：季對季26%。想看看能否提供這個數字更多背景？例如，這個數字與前一期Q1相比如何？另外，基於你們目前看到的情況，我們在Q3大概應該如何看待成長？

Thanks for the question. So regarding the new-to-brand growth rate, I think one thing that could be helpful in the first quarter, we saw essentially equivalent growth from both the total prescriptions and new-to-brand prescriptions perspective. In Q2, we saw a step-up in growth, 26% with new-to-brand prescriptions and 12% for total prescriptions. I think that's a strong signal of the impact of our sales force expansion in the quarter, and we would expect that to continue to build into the second half of the year.

謝謝你的問題。關於新品牌成長率，我想第一季有一點可能有幫助：我們看到總處方量與新品牌處方量的成長基本上相當。在Q2，我們看到成長加速：新品牌處方成長26%，總處方成長12%。我認為這強烈顯示我們本季擴編銷售團隊所帶來的影響，而我們預期這個動能會在下半年持續累積。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，Mizuho Securities。

My question, it's really related to how we should all think about Alzheimer's disease agitation and uptake there. Trying to get a sense of if you could provide some color on how we should think about kind of the smoothness of the uptake? Or do you anticipate that whether it's due to the sales force expansion or just greater awareness that there will be a sharp inflection, whether there are formulary approval dynamics, anything that could give us a better sense of how we should think about the uptake over the next several quarters or a year for that matter.

我的問題主要與我們應該如何看待阿茲海默症躁動的導入與採用（uptake）有關。我想了解你們能否提供一些說明，讓我們知道應該如何看待導入的平滑程度？或者你們是否預期，無論是因銷售團隊擴編或只是認知度提升，會出現明顯的拐點（sharp inflection）；以及是否存在處方集（formulary）核准的動態等因素，能讓我們更好理解未來幾季、甚至一年內的導入節奏。

Yes. Thanks, Graig. I think a couple of points I'd point to. Number one, we expanded the sales force. And in the quarter, we saw meaningful acceleration in new brand prescriptions and new retro activation. As you know, with eight weeks of launch data and Alzheimer's agitation, the majority of that growth came from MDD. We expect MDD to grow as Alzheimer's agitation launch is ramping up.

是的。謝謝，Graig。我想指出幾點。第一，我們擴編了銷售團隊。而在本季，我們看到新品牌處方與新處方者啟動（new writer activation）出現顯著加速。如你所知，在阿茲海默症躁動上市僅八週的數據中，多數成長仍來自MDD（重度憂鬱症）。我們預期在阿茲海默症躁動上市爬坡的同時，MDD也會持續成長。

And well, I think we'll have more to say, obviously, with more data on the Alzheimer's launch. The early indicators are very promising. I think it's premature to say exactly what the inflection will look like. But the early signals that we shared earlier, including the NBRx growth, the positive clinical experience we've received the growth in patients 65 and older, all point to very strong leading indicators that we expect to build throughout the rest of the year.

另外，隨著阿茲海默症上市取得更多數據，我們當然會有更多可以分享。早期指標非常令人鼓舞。我認為現在要精確說明拐點會長什麼樣子仍言之過早。但我們先前分享的早期訊號，包括NBRx成長、我們收到的正向臨床使用經驗、以及65歲以上患者的成長，都指向非常強的領先指標；我們預期這些將在今年剩餘時間持續累積。

David Hoang, Deutsche Bank.

David Hoang，Deutsche Bank。

So I want to ask a little bit about any, let's say, qualitative commentary. You may be getting from your field force about how docs are thinking about the decision for a branded product in Alzheimer's agitation. So obviously, there is the Rexulti is the other approved product out there. And so any color commentary on how docs are approaching AUVELITY versus Rexulti would be helpful? And then are you hearing anything in terms of step edits or prior authorization that payers are asking for ADA.

我想問一些偏質性的評論。你們可能從前線團隊那裡聽到，醫師在阿茲海默症躁動上，對於選擇品牌藥的決策是怎麼想的。顯然，Rexulti是目前另一個已核准的產品。因此，若能分享一些醫師如何看待AUVELITY相對於Rexulti的看法，會很有幫助。另外，你們是否聽到支付方對ADA提出任何階梯式用藥（step edits）或事前授權（prior authorization）的要求？

Yes. Thanks, David. I think, first of all, there's still a significant need for provider education, the Alzheimer's disease agitation market. This is a market that did not have any approved products just a couple of years ago. And so there's still some education required, which we've been really proud to be a part of treatment intervention has often been reserved for more severe forms of agitation, particularly in primary care. And so that's been a point of education regarding the benefits and rationale for earlier innovation.

是的。謝謝你，David。我認為，首先，在阿茲海默症激動（agitation）市場方面，對醫療提供者教育仍有相當大的需求。這是一個就在幾年前還沒有任何獲批產品的市場。因此仍需要一些教育；我們也非常自豪能成為其中一部分——治療介入過去往往保留給較嚴重的激動型態，特別是在基層醫療中。因此，針對更早期創新介入的益處與理由，這一直是我們教育的重點。

As it relates to branded products, I think, ultimately, providers want to help patients, and there has not been anything approved with this type of profile historically. And so there's a lot of interest in learning more about the clinical profile both from an efficacy, safety tolerability standpoint. And the leading indicators, I think, are very promising in that regard.

就品牌藥而言，我認為最終醫療提供者都希望幫助病人，而過去從未有任何具備這類特徵的產品獲批。因此，大家對於進一步了解其臨床特徵非常有興趣，包括療效、安全性與耐受性等面向。而我認為目前的領先指標在這方面相當令人鼓舞。

From an access standpoint, we're really pleased with the coverage that we had at launch, 100% coverage in the Medicare channel. More than 75% of patients do not require a PA. Of course, PAs can still pop up depending on the patient's coverage. In terms of step edits, by and large, we're very pleased that patients will gain access to the albeit based on their prior treatment experience or based on the coverage that they have.

從可近性（access）的角度來看，我們對上市時取得的給付覆蓋非常滿意，在 Medicare 通路達到 100% 覆蓋。超過 75% 的病人不需要事前授權（PA）。當然，依病人的保險給付情況不同，仍可能會出現 PA。至於階梯式用藥限制（step edits），整體而言我們也很滿意；病人將能獲得用藥可近性——不過仍會取決於其既往治療經驗或其所擁有的給付。

And so all of those things really point to continued progress in the launch moving forward, and we'll obviously share more updates as we get more data moving forward.

因此，這些因素都顯示上市推進將持續取得進展；隨著我們取得更多資料，後續也會分享更多更新。

Yatin Suneja, Guggenheim.

Yatin Suneja，Guggenheim。

This is Eddie on for Yatin. So acknowledging it's still very early, what are prescribers telling you about early patient response and continuation on AUVELITY and ADA? Are you picking up any differences by prescriber setting just in terms of how they're monitoring or plan to monitor and follow-up with patients as they get treated?

我是代替 Yatin 的 Eddie。在承認目前仍非常早期的前提下，處方醫師對於病人早期反應以及在 AUVELITY 與 ADA 上的持續用藥情況，跟你們回饋了什麼？就處方場域而言，你們是否觀察到任何差異，例如他們在監測方式、或計畫如何監測與追蹤接受治療的病人？

Yes. Thanks for the question, Eddie. I think the response has been really consistent regardless of setting of care or specialty. And that is that AUVELITY has been effective at reducing both the frequency and severity of agitation symptoms with a favorable safety tolerability profile we'll obviously learn more as the launch progresses. But so far, it's been very consistent, both in terms of specialists as well as setting of care.

是的。謝謝你的問題，Eddie。我認為不論照護場域或專科別，回應都相當一致。也就是 AUVELITY 在降低激動症狀的頻率與嚴重程度方面有效，且安全性與耐受性特徵良好；隨著上市推進，我們顯然會學到更多。但到目前為止，不論是專科醫師或不同照護場域，結果都非常一致。

Madison El-Saadi, B. Riley Securities.

Madison El-Saadi，B. Riley Securities。

Maybe on the 2Q revenue, how much of that reflects any kettle stocking versus spins demand? If you could just help, sorry if I missed it. And if you could just help clarify the underlying operating cash burn, if you stop working capital and everything away. Just asking in the context of your past to breakeven?

關於第二季營收，其中有多少反映了通路備貨（stocking），相對於終端需求（demand）？如果你能協助說明一下——抱歉如果我漏聽了。另外，如果把營運資金等因素都剔除，你能否協助釐清底層的營運現金消耗（cash burn）？我是在你們過去談到達到損益兩平的脈絡下提問。

Sure, Madison. So first off, the full revenue this quarter was related to demand. There was no stocking at the end of the quarter continue to be roughly at two weeks of inventory on hand. So no change as it relates to that.

當然，Madison。首先，本季的全部營收都來自需求。季末沒有備貨；我們的在手庫存仍大約維持在兩週。因此在這方面沒有變化。

And if you take a look at our cash burn for the quarter, it was somewhere in the neighborhood of $24 million or $25 million, taking the net loss and backing out the majority of the noncash loss is related to stock-based comp more than half of that. So your neighborhood does unloaded mid-20s from a cash burn.

如果你看本季的現金消耗，大約在 2,400 萬到 2,500 萬美元左右；以淨損回推並剔除大部分非現金損失，其中與股票基礎薪酬（stock-based comp）相關的占比超過一半。因此現金消耗大致落在 2,000 多萬美元的中段。

And what we shared is that our SG&A for the remainder of the year, we would have anticipated to essentially plateau to where we are this quarter in Q2 of $208 million as we're fully staffed and built the foundation for AUVELITY as well as SYMBRAVO.

我們也分享過，今年剩餘期間的 SG&A，我們預期基本上會在本季水準附近持平，也就是第二季的 2.08 億美元，因為我們已完成招募並建立 AUVELITY 與 SYMBRAVO 的基礎。

R&D will continue to pick up as we've commenced the ADHD trials. But importantly, we should see operating leverage continue in the back half of the year. We saw that this quarter with revenues growing at 14% and OpEx growing at 7%.

隨著我們啟動 ADHD 試驗，研發（R&D）將持續增加。但重要的是，我們應該會在下半年持續看到營運槓桿。本季我們已看到這點：營收成長 14%，而營運費用（OpEx）成長 7%。

Myles Minter, William Blair.

Myles Minter，William Blair。

Team, this is John on for Myles. I was wondering if you can give us any updated plans for the DTC campaign for AUVELITY with the ongoing launch in AD agitation.

各位團隊好，我是代替 Myles 的 John。我想請問，隨著 AUVELITY 在阿茲海默症激動適應症的持續上市推進，你們是否能提供任何更新的 DTC（直接面向消費者）行銷活動規劃？

Thanks, John. We evaluate -- obviously, DTC is an important part of our marketing mix, and we've been pleased with the impact of our direct-to-consumer investments across really all of our brands, but Albeit specifically over the past year or so. Given that it's still only eight weeks into the launch, we're assessing the potential for a more substantial DTC effort.

謝謝你，John。我們會評估——顯然 DTC 是我們行銷組合中重要的一部分；我們也對直接面向消費者投資在幾乎所有品牌上的影響感到滿意，尤其是過去一年左右的 Albeit。鑑於上市才進行八週，我們正在評估是否有機會投入更大規模的 DTC 力道。

Right now, we are investing in consumer marketing, primarily focused on care partners but the potential for something more broad reaching like TV or video advertising is something that we'll continue to evaluate as the launch progresses.

目前我們正投入消費者行銷，主要聚焦於照護夥伴（care partners）；但像電視或影音廣告這種更廣泛觸及的作法，我們會隨著上市進展持續評估。

We reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

我們的問答環節到此結束。我想把時間交回去，看看是否有任何進一步或結語評論。

Thank you. Our Axsome business advanced significantly in the second quarter. Our commercial strategy is translating into long adoption of our medicines. Our pipeline continues to progress towards multiple milestones with substantial value creation potential.

謝謝。Axsome 的業務在第二季取得顯著進展。我們的商業策略正轉化為我們藥物的長期採用。我們的研發管線持續朝多個里程碑推進，具備可觀的價值創造潛力。

Our strong financial position allows us to continue investing behind our strategic priorities to maximize the long-term potential of our portfolio of medicines. We are excited for the remainder of the year and look forward to sharing updates on our progress. Thank you all for joining us and have a great day.

我們強勁的財務狀況，使我們能持續在策略優先事項上投入，以最大化我們藥物組合的長期潛力。我們對今年剩餘時間感到振奮，並期待分享我們進展的更新。感謝各位參與，祝大家有美好的一天。

Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

謝謝。今天的電話會議與網路直播到此結束。您現在可以掛斷電話線，祝您有美好的一天。感謝您今天的參與。