Axsome Therapeutics Inc (AXSM) 2025 Q1 法說會逐字稿

Greetings, and welcome to the Axsome Therapeutics first-quarter 2025 conference call and webcast. (Operator Instructions)

大家好，歡迎參加 Axsome Therapeutics 2025 年第一季電話會議和網路廣播。（操作員指示）

As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Darren, please go ahead.

提醒一下，本次會議正在錄製中。現在我很高興將電話轉給主持人，Axsome Therapeutics 公司企業傳播總監 Darren Opland。達倫，請繼續。

Thank you. Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a business update and details of the company's financial results for the first quarter of 2025. The release crossed the wire a short time ago and is available on the investors section of our website, along with the earnings presentation accompanying today's call. Those joining via webcast may advance through the slides at any time during the discussion.

謝謝。早安，感謝大家參加今天的電話會議。今天上午，我們發布了收益新聞稿，提供了業務更新和公司 2025 年第一季財務業績的詳細資訊。新聞稿不久前發布，可在我們網站的投資者部分查閱，同時還可查閱今天電話會議的收益報告。透過網路直播加入的人員可以在討論期間隨時瀏覽幻燈片。

During today's call, we will be making certain forward-looking statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agents, our clinical and nonclinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, commercial plans and possible intended use of cash and investments.

在今天的電話會議中，我們將做出某些前瞻性陳述，其中包括我們的研究藥物的功效、安全性和預期用途、我們的臨床和非臨床計劃、我們提供或報告額外數據的計劃、預期進行的未來臨床試驗和來源、監管計劃、未來研發計劃、商業計劃以及現金和投資的可能預期用途。

These forward-looking statements are based on current information, assumptions and expectations of future events that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

這些前瞻性陳述是基於當前資訊、假設和對未來事件的預期，這些資訊、假設和預期可能會發生變化，並涉及風險和不確定性，可能導致實際結果與前瞻性陳述中的結果有重大差異。

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements.

我們向美國證券交易委員會提交的定期文件中描述了這些風險和其他風險，包括我們的季度和年度報告。請注意不要依賴這些前瞻性陳述，這些陳述僅截至今天才做出，且本公司不承擔更新此類陳述的任何義務。

Turning to today's agenda. Dr. Herriot Tabuteau, our CEO, will open today's discussion with an overview of our performance and key upcoming catalysts; Nick Pizzie, our Chief Financial Officer, will review our financial results for the quarter; Ari Maizel, our Chief Commercial Officer, will then provide a commercial update; Mark Jacobson, our Chief Operating Officer; and Hunter Murdock, our General Counsel, will be joining us for Q&A.

談談今天的議程。我們的執行長 Herriot Tabuteau 博士將在今天的討論中概述我們的業績和即將到來的關鍵催化劑；我們的首席財務官 Nick Pizzie 將回顧我們本季度的財務業績；我們的首席商務官 Ari Maizel 將提供商業更新；我們的首席營運官 Mark Jacobson 和我們的總法律顧問 Hunterdock 將與我們一起進行問答。

And with that, I'll turn the call over to Herriot.

說完這些，我會把電話轉給赫里奧特。

Thank you, Darren, and good morning, everyone. Axsome entered 2025 with strong momentum across the business. In the first quarter, we delivered year-over-year total revenue growth of 62%, driven by robust underlying demand for Auvelity and Sunosi. In addition, the recent FDA approval of Symbravo, our second internally developed product, reflects Axsome's commitment to delivering innovative medicines with the potential to meaningfully improve upon the standards of care for patients living with serious CNS conditions.

謝謝你，達倫，大家早安。Axsome 以強勁的業務勢頭邁入 2025 年。第一季度，由於 Auvelity 和 Sunosi 的強勁潛在需求，我們的總營收年增了 62%。此外，FDA 最近批准了我們第二款內部開發的產品 Symbravo，這反映了 Axsome 致力於提供創新藥物的承諾，這些藥物有可能顯著改善患有嚴重中樞神經系統疾病患者的護理標準。

Our portfolio today is distinctively diversified and strategically positioned to drive durable growth. Earlier this year, I outlined key priorities related to our pipeline. The first was to advance our 3 novel NDA stage product candidates toward regulatory filings. These include AXS-14 for the management of fibromyalgia, AXS-05 in Alzheimer's disease agitation and AXS-12 for the treatment of cataplexy and narcolepsy.

我們目前的投資組合具有獨特的多元化，並具有推動持久成長的策略定位。今年早些時候，我概述了與我們的管道相關的關鍵優先事項。首先是推動我們 3 個新型 NDA 階段候選產品向監管備案。其中包括用於治療纖維肌痛的 AXS-14、用於治療阿茲海默症躁動的 AXS-05 以及用於治療猝倒症和發作性睡病的 AXS-12。

The second was to successfully execute across our multiple Phase III clinical programs that broaden the potential of our current products and product candidates, including AXS-05, solriamfetol and Symbravo. Since just the beginning of this year, we've made significant progress on both fronts, which underscores the agility and operational excellence of our organization.

第二個是成功執行我們的多個 III 期臨床項目，拓寬我們目前產品和候選產品的潛力，包括 AXS-05、solriamfetol 和 Symbravo。自今年年初以來，我們在這兩個方面都取得了重大進展，這突顯了我們組織的敏捷性和卓越運作。

Starting with AXS-14 for the treatment of fibromyalgia. We have submitted our NDA to the FDA for AXS-14, and anticipate a decision on the acceptance of the filing in the second quarter. Fibromyalgia is a chronic and often debilitating the vision characterized by widespread pain, fatigue, sleep disturbance and cognitive impairment. Recent research suggests that there are over 17 million people in the US who are living with fibromyalgia.

從 AXS-14 開始治療纖維肌痛。我們已向 FDA 提交了 AXS-14 的 NDA，預計將在第二季度做出是否接受該申請的決定。纖維肌痛症是一種慢性疾病，通常會使人視力衰弱，其特徵是廣泛的疼痛、疲勞、睡眠障礙和認知障礙。最近的研究表明，美國有超過 1700 萬人患有纖維肌痛。

Despite this prevalence, there has been no meaningful therapeutic innovation in more than 15 years, while currently available treatment options offer variable efficacy and do not address all key symptoms of this condition. AXS-14 has the potential to address this unmet medical need in the treatment of fibromyalgia if approved.

儘管這種疾病很普遍，但 15 多年來一直沒有出現任何有意義的治療創新，而目前可用的治療方案療效各異，並不能解決這種疾病的所有主要症狀。如果獲得批准，AXS-14 有可能解決纖維肌痛治療中尚未滿足的醫療需求。

Turning now to AXS-05 for the treatment of Alzheimer's disease agitation. In March, we announced a positive FDA pre-meeting minutes regarding our planned supplemental NDA submission for AXS-05 in the syndication, which reinforced our key assumptions related to our data package and filing timeline.

現在轉向 AXS-05 來治療阿茲海默症躁動。3 月份，我們公佈了一份積極的 FDA 會前會議紀要，內容涉及我們計劃在聯合組織中提交 AXS-05 的補充 NDA，這強化了我們與數據包和提交時間表相關的關鍵假設。

We continue to make steady progress here and anticipate submitting the sNDA to the FDA in the third quarter of this year with a potential FDA decision and launch in 2026 if approved. AXS-05 has been granted breakthrough therapy designation by the FDA. If approved, it would address the serious and debilitating unmet medical need, which is estimated to impact over 4 million people in the US alone. Separately, we are also making progress on our development plans for AXS-05 for the treatment of smoking cessation and anticipate initiating a Phase II-III trial of AXS-05 in this indication this year.

我們在此方面繼續取得穩步進展，預計將於今年第三季向 FDA 提交 sNDA，FDA 可能會做出決定，如果獲得批准，則將於 2026 年推出。AXS-05 已被 FDA 授予突破性療法認定。如果獲得批准，它將解決嚴重且令人衰弱的未滿足的醫療需求，據估計僅在美國就會影響超過 400 萬人。另外，我們也正在推動 AXS-05 用於戒菸治療的開發計劃，並預計今年將啟動 AXS-05 用於該適應症的 II-III 期試驗。

Moving on to AXS-12, our novel product candidate for the treatment of narcolepsy with cataplexy. We previously announced the completion of our registration program, which consists of three controlled Phase II and Phase III efficacy trials in a long-term safety trial. We continue to work toward our plan NDA submission, which we anticipate in the second half of this year.

接下來介紹 AXS-12，這是我們用於治療猝倒性嗜睡症的新型候選產品。我們先前宣布已完成註冊計劃，該計劃包括一項長期安全性試驗中的三項受控的 II 期和 III 期療效試驗。我們將繼續致力於提交我們的計劃保密協議 (NDA)，預計將在今年下半年完成。

Despite the currently available treatment options, many patients with narcolepsy remain inadequately managed due to the heterogeneity of the condition and variable response and tolerability to currently approved agents. Based on the clinical data to date, AXS-12 has the potential to deliver rapid and durable improvements in cataplexy while also demonstrating potential across other key symptom areas.

儘管目前有多種治療選擇，但由於病情的異質性以及對目前核准的藥物的反應和耐受性各異，許多嗜睡症患者仍未得到充分治療。根據迄今為止的臨床數據，AXS-12 有可能快速且持久地改善猝倒症，同時也顯示出在其他關鍵症狀領域的潛力。

Shifting now to our ongoing Phase III clinical development programs for solriamfetol, which is being evaluated in ADHD, MDD, binge eating disorder and excessive sleepiness associated with shift work disorder. In the first quarter, we announced positive top line results from the FOCUS Phase III trial of solriamfetol in adults with ADHD. With these promising results in hand, we plan to initiate a Phase III pediatric trial for solriamfetol in ADHD later this year.

現在轉向我們正在進行的 solriamfetol 第三階段臨床開發項目，該項目正在對 ADHD、MDD、暴食症和與輪班工作障礙相關的過度嗜睡進行評估。在第一季度，我們公佈了針對患有 ADHD 的成年人進行的 solriamfetol 治療的 FOCUS III 期試驗的積極頂線結果。有了這些令人鼓舞的結果，我們計劃在今年稍後啟動 solriamfetol 治療 ADHD 的 III 期兒科試驗。

We also reported top line results for the PARADIGM study, which was a Phase III proof-of-concept trial, evaluating the efficacy and safety of solriamfetol in MDD with and without excessive daytime sleepiness or EDS. In the prespecified subgroup of patients with severe EDS, treatment with solriamfetol resulted in numerically greater improvements in depressive symptoms.

我們也報告了 PARADIGM 研究的頂線結果，這是一項 III 期概念驗證試驗，評估了 solriamfetol 對伴有和不伴有過度日間嗜睡或 EDS 的 MDD 的療效和安全性。在預先指定的嚴重 EDS 患者亞群中，使用 solriamfetol 治療可使憂鬱症狀有更顯著的改善。

Based on these results, we plan to initiate a Phase III trial for solriamfetol in MDD patients with EDS later this year. In parallel, we remain focused on advancing our additional Phase III trials of solriamfetol in binge eating disorder and excessive weakness associated with shift work disorder with top line results from both studies anticipated in 2026.

基於這些結果，我們計劃在今年稍後啟動針對患有 EDS 的 MDD 患者的 solriamfetol 的 III 期試驗。同時，我們將繼續致力於推進 solriamfetol 在暴食症和輪班工作障礙相關的過度虛弱症方面的額外 III 期試驗，預計這兩項研究的最終結果將於 2026 年公佈。

Lastly, in February, we announced positive top line results from the EMERGE Phase III trial of Symbravo in migraine patients experiencing inadequate response to oral CGRP inhibitors. Results of this study reinforced the unique clinical profile and potential of Symbravo to provide meaningful efficacy to patients living with migraine.

最後，在二月份，我們宣布了 Symbravo 對口服 CGRP 抑制劑反應不足的偏頭痛患者進行的 EMERGE III 期試驗的積極頂線結果。這項研究的結果強化了 Symbravo 獨特的臨床特性和為偏頭痛患者提供有意義療效的潛力。

As demonstrated by these important milestones we have achieved across our commercial and pipeline programs, Axsome continues to execute with discipline and focus. While we are closely monitoring trade policy developments, including proposed pharmaceutical tariffs, we believe that any potential impact to our business would be immaterial.

正如我們在商業和管道項目中取得的這些重要里程碑所證明的那樣，Axsome 將繼續以紀律和專注力執行。雖然我們正在密切關注貿易政策的發展，包括擬議的藥品關稅，但我們認為對我們業務的任何潛在影響都是微不足道的。

In particular, the vast majority of our commercial manufacturing takes place in the US and Canada, including our primary production facilities for Auvelity and Symbravo, and we do not commercialize these products outside the US. Additionally all intellectual properties related to Auvelity, AXS-05 and Symbravo are dociled in the US.

具體來說，我們的絕大多數商業製造都在美國和加拿大進行，包括 Auvelity 和 Symbravo 的主要生產設施，而且我們不會在美國以外的地方商業化這些產品。此外，與 Auvelity、AXS-05 和 Symbravo 相關的所有智慧財產權均在美國境內。

We appreciate that this is a key focus area for investors. And it is challenging environments like today that truly underscore the depth, resilience and adaptability of our business. We look forward to providing more updates on our progress as we expect 2025 to be another catalyst rich year.

我們知道這是投資人關注的重點領域。正是當今充滿挑戰的環境真正凸顯了我們業務的深度、彈性和適應性。我們期待提供更多有關我們進展的最新信息，因為我們預計 2025 年將是另一個催化劑豐富的一年。

With potentially five marketed products across six indications by 2026, we are in a strong position to continue delivering innovation to patients and significant value to shareholders.

到 2026 年，我們可能將擁有涵蓋六種適應症的五種上市產品，我們有能力繼續為患者提供創新並為股東創造巨大價值。

With that, I'll hand the call over to Nick, who will provide details of our financial performance.

說完這些，我將把電話交給尼克，他將提供我們財務表現的詳細資訊。

Thank you, Herriot, and good morning, everyone. Today, I will discuss our first quarter results and provide some financial guidance. Total product revenues were $121.5 million for the first quarter, representing year-over-year growth of 62%. This consisted of net product sales of $120.4 million and royalty revenue of $1.1 million. Total product revenue for the comparable period in 2024 was $75 million.

謝謝你，赫里奧特，大家早安。今天，我將討論我們的第一季業績並提供一些財務指導。第一季產品總營收為 1.215 億美元，年增 62%。其中包括 1.204 億美元的淨產品銷售額和 110 萬美元的特許權使用費收入。2024 年同期的總產品收入為 7,500 萬美元。

Auvelity net product sales were $96.2 million for the first quarter of 2025, representing 80% year-over-year growth. Auvelity net product sales for the comparable period in 2024 were $53.4 million. Sunosi net product revenues were $25.2 million for the first quarter of 2025, representing 17% year-over-year growth and consisting of $24.1 million in net product sales and $1.1 million in royalty revenue associated with Sunosi sales in out-licensed territories.

2025 年第一季度，Auvelity 淨產品銷售額為 9,620 萬美元，較去年同期成長 80%。2024 年同期 Auvelity 淨產品銷售額為 5,340 萬美元。2025 年第一季度，Sunosi 淨產品收入為 2,520 萬美元，年增 17%，其中包括 2,410 萬美元的淨產品銷售額和 110 萬美元的與 Sunosi 在授權區域外銷售相關的特許權使用費收入。

Sunosi net product revenue for the comparable period in '24 was $21.6 million, consisting of net sales of $20.7 million and $900,000 in royalty revenue. Auvelity and Sunosi GTN discount for the first quarter were both in the mid-50% range and we anticipate GTN to remain in this range for the balance of the year.

24 年同期 Sunosi 淨產品收入為 2,160 萬美元，其中包括 2,070 萬美元的淨銷售額和 90 萬美元的特許權使用費收入。Auvelity 和 Sunosi GTN 第一季的折扣均在 50% 左右，我們預計 GTN 在今年剩餘時間內仍將保持在這個範圍內。

Total cost of revenue were $9.8 million for the first quarter of 2025 and $6.3 million for the comparable period in 2024. Research and development expenses were $44.8 million for the first quarter of 2025 compared to $36.8 million for the comparable period in '24. The increase was primarily related to the company's four Phase III trials in solriamfetol, CMC costs for the planned launch of Symbravo and higher personnel costs, including non-cash stock-based compensation associated with organizational growth.

2025 年第一季的總營收成本為 980 萬美元，2024 年同期的總營收成本為 630 萬美元。2025 年第一季研發費用為 4,480 萬美元，而 2024 年同期為 3,680 萬美元。成長主要與該公司對 solriamfetol 進行的四項 III 期試驗、計劃推出 Symbravo 的 CMC 成本以及更高的人員成本（包括與組織發展相關的非現金股票薪酬）有關。

Selling, general and administrative expenses were $120.8 million for the first quarter of 2025 compared to $99 million for the comparable period in 2024. The increase was primarily related to commercialization activities for Auvelity, including the expansion of the sales force and higher marketing expenses, prelaunch activities for Symbravo and higher personnel costs, including non-cash stock-based compensation associated with organizational growth.

2025 年第一季的銷售、一般及行政費用為 1.208 億美元，而 2024 年同期為 9,900 萬美元。成長主要與 Auvelity 的商業化活動有關，包括銷售團隊的擴大和更高的行銷費用、Symbravo 的上市前活動和更高的人事成本，包括與組織發展相關的非現金股票薪酬。

Net loss for the first quarter of 2025 was $59.4 million or $1.22 per share compared to a net loss of $68.4 million or $1.44 per share for the comparable period in 2024. The net loss in the first quarter of 2025 includes $26.2 million in non-cash charges comprised primarily of $23.3 million in stock-based compensation expense, $1.5 million in acquisition-related contingent consideration expense and $1.6 million in intangible asset amortization.

2025 年第一季淨虧損為 5,940 萬美元，即每股 1.22 美元，而 2024 年同期淨虧損為 6,840 萬美元，即每股 1.44 美元。2025 年第一季的淨虧損包括 2,620 萬美元的非現金費用，主要包括 2,330 萬美元的股票薪酬費用、150 萬美元的收購相關或有對價費用和 160 萬美元的無形資產攤銷。

We ended Q1 2025 with $300.9 million in cash and cash equivalents compared to $315.4 million as of year-end. We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

截至 2025 年第一季度，我們的現金和現金等價物為 3.009 億美元，而截至年底為 3.154 億美元。我們相信，根據目前的營運計劃，我們目前的現金餘額足以為預期的營運提供資金，實現現金流正向流動。

I will now turn the call over to Ari, who will provide a commercial update.

現在我將把電話轉給 Ari，他將提供商業更新。

Thank you, Nick. Axsome delivered solid commercial performance for Auvelity and Sunosi in the first quarter of 2025 despite market seasonality headwinds at the beginning of the calendar year. Auvelity led the market in TRx growth in Q1, with approximately 167,000 prescriptions, representing 76% year-over-year growth compared to the first quarter of 2024 and 5% sequential quarter-over-quarter growth.

謝謝你，尼克。儘管年初市場面臨季節性逆風，但 Axsome 在 2025 年第一季為 Auvelity 和 Sunosi 帶來了穩健的商業業績。Auvelity 在第一季的 TRx 成長領先市場，處方量約為 167,000 張，與 2024 年第一季相比年增 76%，季增 5%。

Auvelity was one of only two branded MDD agents with sequential brand growth in Q1. By comparison, the antidepressant market was flat compared to the first quarter of 2024 and declined by 2% sequentially. Nearly 26,000 new patients were prescribed Auvelity in the quarter, bringing the total number of new patients started on Auvelity since launch to more than 190,000.

Auvelity 是第一季僅有的兩家實現品牌連續成長的品牌 MDD 代理商之一。相比之下，抗憂鬱藥物市場與 2024 年第一季相比持平，季減 2%。本季有近 26,000 名新患者接受了 Auvelity 治療，自 Auvelity 推出以來，接受該治療的新患者總數已超過 190,000 名。

Auvelity use in the first line or first hit setting is approximately 50% in the quarter, reflecting balanced utilization of Auvelity for patients regardless of prior treatment experience. Our sales team successfully activated 4100 new prescribers in Q1, with continued growth across both psychiatry and primary care settings.

本季度，Auvelity 在第一線治療或首次治療中的使用率約為 50%，這反映了無論患者先前的治療經驗如何，Auvelity 對患者的平衡利用率。我們的銷售團隊在第一季成功啟動了 4100 名新處方人員，並且在精神病學和初級保健領域持續成長。

We're beginning to see the initial impact of our most recent sales force expansion on overall scripts and new patient starts, and we expect continued impact from the expanded sales team throughout the year. Auvelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% of lives in the commercial segment. Based on ongoing negotiations, we expect coverage for Auvelity to expand and improve in 2025.

我們開始看到最近的銷售團隊擴張對整體處方和新患者開始的初步影響，並且我們預計擴大的銷售團隊將在全年持續產生影響。Auvelity 的覆蓋率在第一季保持穩定，涵蓋了所有通路的 78% 的生活，以及商業領域的 63% 的生活。根據正在進行的談判，我們預計 Auvelity 的覆蓋範圍將在 2025 年擴大和改善。

Turning to Sunosi. Total prescriptions were over 46,000, representing 12% growth versus Q1 2024 and a decline of 4.8% sequentially. By comparison, the weight promoting agent market increased by 4% compared to the first quarter of 2024 and declined 5% sequentially.

轉向 Sunosi。總處方量超過 46,000 張，與 2024 年第一季相比成長 12%，與上一季相比下降 4.8%。相比之下，增重劑市場與 2024 年第一季相比成長了 4%，季減了 5%。

Approximately 3,800 new patients started Sunosi in the quarter, bringing the total number of new patients started on Sunosi to approximately 85,000 since launch. Nearly 440 writers were activated in Q1, resulting in a total cumulative prescriber base of more than 14,000 health care providers since launch.

本季約有 3,800 名新患者開始使用 Sunosi，自推出以來，使用 Sunosi 的新患者總數已達到約 85,000 名。第一季有近 440 名寫手被激活，自推出以來累計處方者總數已超過 14,000 名醫療保健提供者。

Payer coverage for Sunosi in Q1 was stable with 83% of lives covered across channels. Finally, our launch preparations for Symbravo are progressing as planned, including the build-out of our sales team and the development of marketing messages, materials and programs. Feedback from health care providers since approval has been very positive due to the large unmet need that still exists in the acute migraine space.

Sunosi 第一季的付款人覆蓋率穩定，透過各個管道覆蓋了 83% 的人。最後，我們為 Symbravo 所做的發布準備工作正在按計劃進行，包括銷售團隊的組建以及行銷資訊、材料和計劃的開發。由於急性偏頭痛領域仍然存在大量未滿足的需求，自批准以來，醫療保健提供者的回饋非常積極。

There has been a strong positive reaction to Symbravo's clinical profile with rapid and durable migraine pain relief that is safe and tolerable. It's multi-mechanistic approach that attacks migraine pain in a unique way relative to other approved agents and Symbravo's novel MoSEIC technology. We look forward to sharing additional details of our commercial launch soon.

Symbravo 的臨床表現得到了強烈的正面回饋，其能夠快速、持久地緩解偏頭痛，並且安全且可以忍受。與其他核准藥物和 Symbravo 的新型 MoSEIC 技術相比，它採用多機制方法，以獨特的方式治療偏頭痛。我們期待很快分享有關我們商業發布的更多細節。

In closing, Q1 was a solid quarter that sets up Axsome for another successful year. Continued advancement of our commercial execution capabilities will support ongoing performance for Auvelity and Sunosi while enabling a potentially strong launch for Symbravo next month.

總而言之，第一季表現穩健，為 Axsome 又一個成功年份奠定了基礎。我們商業執行能力的持續提升將支持 Auvelity 和 Sunosi 的持續表現，同時也為下個月 Symbravo 的強勁上市提供可能。

I will now turn the call back to Darren for Q&A.

現在我將把電話轉回給 Darren 進行問答。

Thanks Ari.

謝謝阿里。

Operator, may we please open the line for questions.

接線員，請問我們可以開通熱線來回答問題嗎？

Certainly when I'll be conducting a question-and-answer session. (Operator Instructions)

當然，當我主持問答環節時。（操作員指示）

Leonid Timashev, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Leonid Timashev。

Hey guys, thanks for taking my question and congratulations on the quarter. So maybe a multipart one. You've got a number of developmental agents in front of the FDA right now. So I wanted to focus on that. I guess what has your sense been from the FDA on recent interactions?

嘿，大家好，感謝你們回答我的問題，並祝賀本季取得佳績。所以可能是多部分的。目前，FDA 面前有許多開發代理商。所以我想集中精力於此。我猜您對 FDA 最近與我的互動有何看法？

Has there been any changes to the review teams or agency responsiveness, or I guess in particular, any evolution on the messaging of what may be required for approval, especially for AXS-05 in Alzheimer's agitation?

審查團隊或機構回應是否有任何變更？或者我猜，特別是在批准所需的資訊傳遞方面是否有任何變化，特別是對於阿茲海默症激動中的 AXS-05？

And then I guess, given that you have breakthrough designation for that agent, I guess how confident are you that you'll be able to get a priority review here? Thanks, and I'll hope back with you.

然後我想，鑑於您對該代理商有突破性的指定，我想您對能夠在這裡獲得優先審查有多大信心？謝謝，希望能夠再次與您聯繫。

Hey Leo, it's Mark, good morning. So right now, engagement and dialogue with FDA is status quo for us, remain status quo. And then with respect to AXS-05 and AD agitation, no changes there versus what we discussed and the feedback we've received from FDA with respect to our planned sNDA submission. And I think you had mentioned that it does have breakthrough therapy designation and it is eligible for prior review. And that's something that determination is made by the agency at the time of filing.

嘿，Leo，我是 Mark，早安。因此，目前，與 FDA 的接觸和對話對我們來說是現狀，保持現狀。然後關於 AXS-05 和 AD 動議，與我們討論的內容以及我們從 FDA 收到的有關我們計劃的 sNDA 提交的反饋相比，沒有任何變化。我認為您提到它確實具有突破性療法認定並且有資格進行事先審查。這是由機構在提交申請時所做的決定。

Marc Goodman, Leerink Partners.

馬克古德曼（Marc Goodman），Leerink Partners。

Yeah, two questions really. One is, can you just give us a sense of when you're going to kick in the DTC advertising for Auvelity? I know that's supposed to happen sometime this year. And then second, the question is really about just the orexins coming in to the narcolepsy class and just how you think about your products sitting in as directions come in? Thank you.

是的，確實有兩個問題。第一個問題是，您能否告訴我們何時開始為 Auvelity 投放 DTC 廣告？我知道這應該會在今年某個時候發生。其次，問題實際上是關於食慾素進入嗜睡症類別，以及您如何看待您的產品在說明書中的作用？謝謝。

Hey Mark, it's Ari. Thanks for the question. Regarding DTC, we expect to launch a national campaign later this year. If you visit our website, you'll see that we have a new creative campaign, but the national campaign launch will be a little bit later this year. Regarding orexin and AXS-12, we're very optimistic about AXS-12, the feedback we got, in particular, most recently at AAN when we shared the SYMPHONY data in an oral presentation that it's a compelling option, daytime dosing, strong impact, not just on cataplexy, but other symptoms of interest.

嘿，馬克，我是阿里。謝謝你的提問。關於 DTC，我們預計將在今年稍後發起全國性的活動。如果您造訪我們的網站，您會看到我們有一個新的創意活動，但全國活動的啟動將在今年稍後進行。關於食慾素和 AXS-12，我們對 AXS-12 非常樂觀，特別是我們最近在 AAN 獲得的反饋，當時我們在口頭報告中分享了 SYMPHONY 數據，這是一個引人注目的選擇，白天服用，不僅對猝倒症有很強的影響，而且對其他感興趣的症狀也有很強的影響。

And the orexins, I think, is enthusiastic and so, there's still questions just about the safety tolerability and it remains to be seen how those drugs will perform and sort of their late-stage products. So we're keeping an eye on it, but we think that there's a real market for AXS-12 in the short term, and we look forward to getting it into the hands of providers and patients.

我認為食慾素類藥物備受青睞，但其安全性和耐受性仍存在疑問，這些藥物的性能如何以及其後期產品如何還有待觀察。因此，我們正在密切關注它，但我們認為 AXS-12 在短期內確實有市場，我們期待它能夠到達供應商和患者的手中。

Thanks.

謝謝。

Andrew Seide, Jefferies.

安德魯·塞德（Andrew Seide），傑富瑞集團（Jefferies）。

Hey, good morning. Congrats on the execution and thanks for taking my question. It's around Auvelity with your recent settlement with Teva for to 2039 time frame. Can you confirm if this is the absolute earliest that any generic out there can enter at this juncture? And does this settlement embolden you to pursue other opportunities outside of smoking cessation and agitation, assuming that you do have guaranteed run rate for at least 13 years. Can we expect more follow-on indications soon? Thank you.

嘿，早安。恭喜您執行了這項決定，感謝您回答我的問題。它與 Auvelity 有關，並且最近與 Teva 達成了 2039 年期限的協議。您能否確認這是目前任何仿製藥能夠進入的最早時間嗎？假設您確實保證至少 13 年的運行率，那麼這項和解是否會鼓勵您尋求戒菸和鼓動之外的其他機會？我們能否很快期待更多後續跡象？謝謝。

Hey, thanks for. The question. This is Hunter. . I'll answer the first part, and then I'll turn it over to Herriot for the second part. For the first part, Teva has a 180 day regulatory exclusivity. So regardless of what happens, Teva will be the first generic to launch. So other generics in file, but they would come in after Teva. And then I'll turn it over to Herriot.

嘿，謝謝你。問題。這是亨特。。我將回答第一部分，然後交給 Herriot 回答第二部分。對於第一部分，Teva 擁有 180 天的監管獨佔權。因此，無論發生什麼，Teva 都將是第一個推出的仿製藥。因此文件中還有其他仿製藥，但它們會在 Teva 之後出現。然後我將把它交給赫里奧特。

Yeah. And in terms of whether it emboldens us to pursue other indications, we have always planned to pursue other indications with AXS-05, given the pharmacology. So the nearest term new opportunities, Alzheimer's disease agitation, and we're on track to file the sNDA for that in the third quarter. And following that, we also have smoking cessation, and we are on track to initiate a Phase III trial in smoking cessation this year.

是的。至於它是否鼓勵我們尋求其他適應症，考慮到藥理學，我們一直計劃使用 AXS-05 尋求其他適應症。因此，最近的新機會是阿茲海默症的治療，我們預計在第三季為此提交 sNDA。接下來，我們還有戒菸研究，我們計劃在今年啟動戒菸研究的第三階段試驗。

Thanks.

謝謝。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Hi, great, thanks for bringing my question. For AD agitation, so thanks for providing the clarity that it will be in sNDA. Just curious, how does that impact the commercial potential here? I would imagine that you would have been more favorably positioned on GTN if it was its own NDA as opposed to getting lumped into depression, which now you're run rating at 55 -- mid-55 -- mid-50 gross to net. Thanks.

你好，太好了，謝謝你提出我的問題。對於 AD 激動，感謝您明確表示它將在 sNDA 中。只是好奇，這對這裡的商業潛力有何影響？我可以想像，如果 GTN 有自己的保密協議，那麼您在 GTN 上的地位會更有利，而不是被捲入蕭條之中，現在您的運營評級為 55 - 55 中 - 50 中毛利與淨利之比。謝謝。

Thanks, Ash, for the question. I think the sNDA does provide some clarity regarding promotion of AXS-05. It will share the Auvelity's name. As it relates to your question on GTN, I think that, that's one way of thinking about it. The other is that we expect, based on or existing payer contracts and the ongoing negotiation, there is a familiarity with the product and sort of the clinical profile overall has been very positive.

謝謝 Ash 提出這個問題。我認為 sNDA 確實為 AXS-05 的推廣提供了一些清晰的說明。它將與 Auvelity 共享名稱。至於您在 GTN 上提出的問題，我認為這是一種思考方式。另一個是，我們預計，基於現有的付款人合約和正在進行的談判，人們對該產品很熟悉，而且總體而言，臨床概況非常積極。

So we think of this as being ultimately beneficial to helping secure access for the new indication. And so the GTN component, I'm not sure that we see it necessarily the same way, but ultimately, we need to get an approval for this indication and expand our existing contracts in order to secure access for the new patients. So we're feeling pretty good about the sNDA. We think there's some really nice advantages from a commercial standpoint, and we look forward to sharing some more in the future.

因此，我們認為這最終有利於幫助確保獲得新適應症的治療。因此，對於 GTN 成分，我不確定我們是否一定以相同的方式看待它，但最終，我們需要獲得該適應症的批准並擴大我們現有的合同，以確保新患者能夠獲得治療。所以我們對 sNDA 感覺非常良好。我們認為從商業角度來看這確實有一些優勢，我們期待在未來分享更多。

Ram Selvaraju, H.C. Wainwright.

拉姆‧塞爾瓦拉朱 (Ram Selvaraju)，H.C.溫賴特。

Thanks very much for taking my questions. Firstly, I was wondering if you could comment on your expected cadence of coverage for Symbravo following the launch rollout next month in terms of how quickly you expect Symbravo to reach qualitatively the same level of access that you currently have secured for Auvelity and Sunosi.

非常感謝您回答我的問題。首先，我想知道您是否可以評論一下下個月推出後 Symbravo 的預期覆蓋節奏，即您預計 Symbravo 多快能達到目前為 Auvelity 和 Sunosi 獲得的相同訪問級別。

And then secondly, I was wondering with respect to the additional indications for solriamfetol, would you say that at this point, given the information you currently have, that binge-eating disorder represents the most attractive opportunity from a competitive positioning standpoint? Or is one of the other indications still likely to be more attractive in terms of overall commercial value. Thank you.

其次，我想知道關於 solriamfetol 的其他適應症，根據您目前掌握的信息，您是否認為從競爭定位的角度來看，暴食症代表著最具吸引力的機會？或者其他跡象之一在整體商業價值方面可能仍然更具吸引力。謝謝。

Thanks, Ram for the question. Regarding coverage for Symbravo and the cadence, obviously, we're focused right now on negotiations for Symbravo. I think it's premature to say exactly what the cadence would be, but we are focused on securing access as quickly as we can, understand it is a highly competitive market, but there's still significant unmet need and Symbravo's unique clinical profile, we believe, has significant advantages for patients and payers are seeing that clinical value. So I would say stay tuned for additional updates regarding market access on Symbravo.

謝謝 Ram 提出這個問題。關於 Symbravo 的報導和節奏，顯然，我們現在專注於 Symbravo 的談判。我認為現在說出確切的節奏還為時過早，但我們專注於盡快確保訪問，了解這是一個競爭激烈的市場，但仍有很大的未滿足需求，我們相信 Symbravo 獨特的臨床特徵對患者有顯著優勢，付款人也看到了這種臨床價值。因此我想說，請繼續關注有關 Symbravo 市場准入的更多更新。

Great. This is Herriot. With regards to the second question on solriamfetol in the additional indications and how we see the product's positioned versus competitors. We really like the profile of this for solriamfetol. We've announced positive results in ADHD.

偉大的。這是赫里奧特。關於第二個問題，關於 solriamfetol 的附加適應症以及我們如何看待產品相對於競爭對手的定位。我們真的很喜歡 solriamfetol 的這款產品。我們宣布了在過動症治療方面取得的積極成果。

And while you can't make cross-trial comparisons and you'll always be careful about that because different trials are run in different patient populations. It was encouraging that the improvement from baseline in terms of the primary endpoint, the AISRS was one part with what is seen with currently approved stimulant agents. So we really like that. And obviously, there'll be further characterization of the clinical profile in ADHD.

雖然您無法進行跨試驗比較，但您始終要對此保持謹慎，因為不同的試驗是在不同的患者群體中進行的。令人鼓舞的是，就主要終點而言，AISRS 相對於基線的改善與目前批准的興奮劑藥物的改善是一致的。所以我們真的很喜歡這個。顯然，我們將進一步描述 ADHD 的臨床特徵。

As it relates to binge eating disorder, it's too early to make pronouncements there. Obviously, there's only one other product which is approved for binge eating disorder. So if solriamfetol were to be successful, it will be the second product. So from a competitive perspective, that is a very nice dynamic to have. However, we have to wait to see what the results of the Phase III trial are.

由於它與暴食症有關，現在下結論還為時過早。顯然，只有另外一種產品被批准用於治療暴食症。因此，如果 solriamfetol 成功的話，它將成為第二種產品。因此從競爭的角度來看，這是一種非常好的動態。不過，我們還需要等待第三階段試驗的結果。

Thank you.

謝謝。

Charles Duncan, Cantor Fitzgerald.

查爾斯鄧肯、康托菲茨傑拉德。

Hey, morning, Herriot and team, congrats on a good quarter. Thanks for taking our question. My first question is on Symbravo. I think Ari mentioned Symbravo launch coming up here in terms of building out the sales team. Could you give us any idea of kind of what that means in terms of number of persons or focus, would you perhaps focus on sites that are treating migraine and therefore, helpful to the rest of the portfolio? And then when do you anticipate being able to present some of the recent data on Symbravo, including responsive CGRPs. Could that be at the American Headache Society Meeting later in June?

嘿，早安，Herriot 和團隊，恭喜你們本季取得了良好的成績。感謝您回答我們的問題。我的第一個問題是關於 Symbravo 的。我認為 Ari 提到 Symbravo 的推出是為了組建銷售團隊。您能否告訴我們，從人數或重點來看，這意味著什麼，您是否會專注於治療偏頭痛的網站，從而對投資組合的其他部分有幫助？那麼，您預計何時能夠展示有關 Symbravo 的一些最新數據，包括響應性 CGRP。這可能是在六月底舉行的美國頭痛學會會議上嗎？

Hey Charles, thanks for the question. So regarding Symbravo selling effort, we are close to the completion of the build-out of that sales team. We expect to have approximately 100 sales representatives focused primarily on a highly concentrated group of acute migraine treaters and headed centers and large neurology practices.

嘿，查爾斯，謝謝你的提問。因此，就 Symbravo 的銷售工作而言，我們已接近完成該銷售團隊的組建。我們預計將有大約 100 名銷售代表主要負責高度集中的急性偏頭痛治療者群體以及中心和大型神經病學診所。

Your point about synergy with the existing portfolio is something that we are taking a close look at. There is some utilization in the psychiatric space, I'd say the synergy is more pronounced than the primary care space.

我們正在仔細研究您關於與現有投資組合產生協同作用的觀點。在精神病學領域有一些利用，我認為協同作用比初級保健領域更為明顯。

That's something that we'll continue to evaluate for future promotional efforts.

我們將在未來的促銷活動中繼續評估這一點。

So as you can imagine, AHS will be a very important scientific meeting for us, and we do expect to have presence there.

因此，你可以想像，AHS 對我們來說將是一次非常重要的科學會議，我們確實希望出席。

Okay, great. Thanks.

好的，太好了。謝謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Hey, thanks. I wanted to drill down more on esreboxetine and fibromyalgia. I know you talked about it. I'm wondering, number one, how are you thinking about the sales opportunity. At one point over a decade ago Pfizer was prioritizing LYRICA and fibro, Lilly was prioritizing Cymbalta in fibro. So there's a big opportunity.

嘿，謝謝。我想更深入了解艾司波西汀和纖維肌痛。我知道你談論過這個。我想知道，首先，您如何看待銷售機會。十多年前，輝瑞公司曾優先考慮 LYRICA 和纖維蛋白原治療，而禮來公司則優先考慮 Cymbalta 治療纖維蛋白原治療。因此這是一個很大的機會。

Lots of DTC. Of course, those products are generic now. So how do you think about the underlying opportunity, given on one hand, the size of the market, and on the other hand, the fact that there are generics of these products. So that's number one. And then number two, what's the extent to which you're going to expand the sales force to support esreboxetine? Thanks.

大量 DTC。當然，這些產品現在都是通用的。那麼，一方面考慮到市場規模，另一方面考慮到這些產品存在仿製藥的事實，您如何看待潛在的機會？這是第一點。第二，您打算在多大程度上擴大銷售團隊來支持艾司波西汀？謝謝。

Yeah, thanks, David. Thanks, David. We're very enthusiastic about AXS-14 and its potential impact. Fibromyalgia, as you mentioned, it's a large market. There are about 17 million people in the US diagnosed with fibromyalgia. And so when you think about promotional efforts, the indication is treated by a diverse group of ACT in rheumatology, primary care pain, neurology and psychiatry.

是的，謝謝，大衛。謝謝，大衛。我們對 AXS-14 及其潛在影響非常熱衷。正如您所說，纖維肌痛是一個巨大的市場。美國約有 1700 萬人被診斷出患有纖維肌痛。因此，當您考慮促銷活動時，此適應症由風濕病學、初級保健疼痛、神經病學和精神病學領域的多種 ACT 組進行治療。

When we look at the key focus is the concentration, specifically in rheumatology and primary care markets. We're continually evaluating the appropriate size and structure for the AXS-14 sales team but we do believe there will be -- likely be a mix of utilizing existing sales teams as well as adding additional sales efforts particularly for the rheumatology space. And as it relates to consumer advertising, stay tuned for more information.

當我們觀察時，重點是集中度，特別是在風濕病學和初級保健市場。我們正在不斷評估 AXS-14 銷售團隊的適當規模和結構，但我們確實相信，可能會結合利用現有的銷售團隊以及增加額外的銷售力度，特別是針對風濕病學領域。由於它與消費者廣告相關，請繼續關注更多資訊。

We're evaluating the most effective way of engaging with patients. As you know, this is a long dormant market from a promotional standpoint. So we're looking at novel ways of engaging with patients in the future.

我們正在評估與患者互動最有效的方式。如您所知，從促銷的角度來看，這是一個長期處於休眠狀態的市場。因此，我們正在尋找未來與患者互動的新方式。

Okay, thanks.

好的，謝謝。

David Hoang, Deutsche Bank.

德意志銀行的 David Hoang。

Hi there, good morning. Congrats on the quarter and thanks for taking my questions. So first, I wanted to ask on Auvelity. Could you just give a little bit more color on your expectations for how payer coverage might evolve for the product over the course of this year?

大家好，早安。恭喜本季取得佳績，感謝您回答我的問題。所以首先，我想在 Auvelity 上提問。您能否更詳細地介紹一下您對今年該產品付款人涵蓋範圍可能如何發展的預期？

I think you have two major GPOs under contract and so just wondering if getting the third one would be key in your efforts to get the coverage you want. And then on Sunosi, could you give a little bit just any color you may have on how you're seeing the growth in the EDS for narcolepsy versus OSA indications? Thanks a lot.

我認為您已經與兩家主要的 GPO 簽訂了合同，因此我想知道與第三家 GPO 簽訂合約是否是您獲得所需保險的關鍵。然後關於 Sunosi，您能否稍微介紹一下您如何看待 EDS 在發作性睡病和 OSA 適應症方面的成長？多謝。

Yes, thanks, David. So regarding Auvelity, our team is focused on two primary objectives, increase the number of covered lives and reduced utilization management such as prior authorizations and step edits. We're pleased with the progress the team has made in negotiations across channels, and we do expect access to further expand and evolve this year and beyond.

是的，謝謝，大衛。因此，關於 Auvelity，我們的團隊專注於兩個主要目標：增加受保人數並減少利用管理，例如事先授權和步驟編輯。我們對團隊在跨通路談判中所取得的進展感到滿意，我們確實希望今年及以後的談判管道能進一步擴大和發展。

As it relates to Sunosi, we have seen really nice growth in both indications, but faster growth in the OSA indication. This is obviously a larger patient population. And based on our interactions with the HCPs, we've seen significant unmet need, particularly in this area where majority of our growth is coming from.

就 Sunosi 而言，我們看到兩種適應症都實現了非常好的成長，但 OSA 適應症的成長速度更快。這顯然是一個更大的患者群體。根據我們與 HCP 的互動，我們發現存在大量未滿足的需求，特別是在我們大部分成長來源的領域。

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

Congrats on strong quarter and thanks for taking our questions. It's great to hear that you have the meeting minutes from the ADA pre-NDA meeting. Any color you can share on how the meeting went. And any notable surprises, if any? And do you plan to have any other meeting before the actual submission in 3Q?And just a quick follow-up. You're now in your third year of Auvelity launch. When do you think you'll be in a position to provide guidance on the Auvelity for MDD? Thank you.

恭喜本季業績強勁，感謝您回答我們的問題。很高興聽到您有 ADA 預 NDA 會議的會議記錄。您可以用任何顏色來分享會議的進展。如果有的話，有什麼值得注意的驚喜嗎？在第三季實際提交之前，您是否計劃舉行其他會議？只是一個快速的跟進。現在正值 Auvelity 推出的第三年。您認為您何時能夠為 MDD 的 Auvelity 提供指導？謝謝。

Hey Joon, I don't know that we have any additional color with respect to the engagement with FDA besides what we disclosed and we're excited about the data we have and our progress towards an sNDA submission. That remains on track. In terms of additional meetings and things like that. Right now, the gating steps between today and the submission are completing build-out of the package. And so that's riding and compiling the module. So we feel good about the work ahead of us. We'll keep you posted.

嘿，俊，除了我們披露的信息之外，我不知道我們在與 FDA 的合作方面還有什麼其他信息，我們對我們擁有的數據和我們在提交 sNDA 方面的進展感到非常興奮。這仍然在進行中。就額外的會議和類似的事情而言。目前，從今天到提交之間的門控步驟正在完成包的建置。這就是對模組的騎行和編譯。因此，我們對未來的工作充滿信心。我們會及時通知您。

Yeah, and Joon, it's Nick. As it relates to sales guidance, yeah, we are in our third year. I would say still a pretty situation as Ari talked about earlier about payer coverage continuing to evolve. We just launched the field force expansion in Q1.

是的，Joon，我是 Nick。就銷售指導而言，是的，我們已經進入第三年了。我想說這仍然是一個很好的情況，正如 Ari 之前談到的，付款人覆蓋範圍正在不斷發展。我們剛剛在第一季啟動了現場人員擴張計畫。

We have the DTC campaign that's going to be occurring later this year. So all of these items will have a material impact. So I understood the question on sales guidance, but I still think it's a bit premature, but we'll direct you to our corporate website where we speak to the range of $1 billion to $3 billion for peak sales for MDD alone, and then larger than that, for ADA.

我們將於今年稍後開展 DTC 活動。因此，所有這些項目都會產生重大影響。因此，我理解有關銷售指導的問題，但我仍然認為現在有點為時過早，但我們會將您引導至我們的公司網站，我們在該網站上討論的 MDD 的峰值銷售額範圍為 10 億美元至 30 億美元，而 ADA 的峰值銷售額則更高。

Cerena Chen, Wells Fargo.

Cerena Chen，富國銀行。

Hi, thanks for taking my question, and congrats on all the positive readout so far. I wanted to ask more about the strategic direction of the pipeline. As you have several assets pending regulatory review, how are you thinking about next steps? Would you say the focus is more on expansion opportunities? Or are there any plans for new molecular entities? Thanks.

你好，感謝您回答我的問題，並祝賀您迄今為止的所有積極成果。我想進一步詢問有關管道的戰略方向。由於您有幾項資產正在等待監管部門審查，您如何考慮下一步？您是否認為重點更多放在擴張機會上？或有沒有新分子實體的計畫？謝謝。

Thanks for the question. Right now, given the breadth of the pipeline and the number of assets that we have that are in late-stage development in any stage products, our focus is to make sure that we execute crisply. So we want to make sure that we execute on these opportunities, which if you look at all the opportunities, given the stage of development in the patient population, has the potential to deliver peak sales of north of $16 billion. So we want to make sure that we execute and take those over the finish line.

謝謝你的提問。目前，考慮到產品線的廣度以及我們在任何階段產品中處於後期開發的資產數量，我們的重點是確保我們能夠清晰地執行。因此，我們希望確保抓住這些機會，如果考慮到患者群體的發展階段，所有這些機會都有可能實現 160 億美元以上的峰值銷售額。因此，我們要確保執行並完成這些目標。

Having said that, there are other opportunities which are always being presented to us as well as opportunities currently internally, which we have not disclosed. And stay tuned for those, and we will disclose them as they mature or as they become appropriate.

話雖如此，我們面前還有其他機會，以及目前內部存在但尚未披露的機會。請繼續關注，我們將在其成熟或適當時披露。

Thank you.

謝謝。

(Operator Instructions)

（操作員指示）

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

Hi guys, thanks for taking our question. This is Pat on for Vikram. Could you comment on your intended design of the Phase III study point to initiate later this year for solriamfetol and MDD with EDS, like how large of a study population do you anticipate? And what do you see as the key endpoints here? And lastly, would this be the only additional trial required for potential approval?

大家好，感謝您回答我們的問題。這是 Vikram 的 Pat on。您能否評論一下您計劃於今年稍後啟動的針對 solriamfetol 和患有 EDS 的 MDD 的 III 期研究點的設計，例如您預計研究人群有多大？您認為這裡的關鍵終點是什麼？最後，這是否是獲得批准所需的唯一額外試驗？

Thank you for the question. What we've done historically is disclose the exact design of the studies once we've launched them. Now we really like what we saw in terms of a signal in this patient population, that is patients with MDD and excessive sleepiness. As a reminder, that represents probably around 50% of patients who have MDD. We will take all the learnings from the study, which we've completed as well as the learnings from other depression trials, which we've conducted with our other products as we think about the design of this next study.

謝謝你的提問。我們過去的做法是，在啟動研究後揭露研究的具體設計。現在，我們真的很喜歡我們在這個患者群體中看到的信號，即患有 MDD 和過度嗜睡的患者。提醒一下，這可能代表了患有 MDD 的患者的 50% 左右。我們將綜合考慮我們已經完成的這項研究以及我們用其他產品進行的其他憂鬱症試驗的所有經驗教訓，來思考下一項研究的設計。

Jason Gerberry, Bank of America.

美國銀行的 Jason Gerberry。

Hey, good morning. Thanks for taking my questions. Just a follow up on the MDD EDS opportunity. Just trying to get a sense of how confident you are that, that really is half the MDD population, given the subgroup was only 15% of the study population?

嘿，早安。感謝您回答我的問題。這只是對 MDD EDS 機會的跟進。只是想了解一下，鑑於該亞組僅佔研究人群的 15%，您對此有多大信心，這確實是 MDD 人口的一半？

Was there anything specific in the enrollment criteria that maybe restricted the enrollment of EDS comorbid patients? And then with respect to your MDD peak sales, $1 billion to $3 billion, when do you think you'll be in a position to narrow that guide?

入選標準中是否存在任何特定內容可能限制 EDS 合併症患者的入選？那麼，關於您的 MDD 峰值銷售額（10 億美元到 30 億美元），您認為何時能夠縮小這個範圍？

I'm just kind of wondering, as you guys think about where you sit today, maybe what are some of the key variables that push you to the high end of $3 billion versus maybe the $1 billion peak sales range. Thanks.

我只是有點好奇，當你們思考自己現在的處境時，也許有哪些關鍵變數推動你們達到 30 億美元的高端銷售額，而不是 10 億美元的峰值銷售額範圍。謝謝。

Sure. As it relates to the MDD in EDS indication, in the study, which we completed, we wanted to see if there was a signal and to ensure that we had great sensitivity as well as specificity, but importantly, specificity. We define the MDD patients with severe EDS. Now if you look at patients who have EDS with MDD, it is about 50% of the population. And in terms of the MDD peak sales potential of more to $3 billion, that does incorporate a lot of different variables.

當然。由於它與 EDS 指徵中的 MDD 相關，在我們完成的研究中，我們想看看是否存在訊號，並確保我們具有很高的敏感性和特異性，但重要的是特異性。我們將 MDD 患者定義為患有嚴重 EDS 的患者。現在，如果你看看 EDS 和 MDD 的患者，你會發現他們佔總人口的 50% 左右。就 MDD 峰值銷售潛力超過 30 億美元而言，這確實包含許多不同的變數。

One of the things to watch is what the trajectory is of our current sales. And as we continue the launch and as other aspects evolve, we might be in a position to narrow guidance. But right now, we feel that, that is a very achievable range. And certainly, the low end of that is very achievable.

需要關注的事情之一是我們當前的銷售軌跡。隨著我們繼續發布以及其他方面的發展，我們可能會縮小指導範圍。但現在，我們認為，這是一個非常容易實現的範圍。當然，這個低端目標也是可以實現的。

Joel Beatty, Baird.

喬爾·比蒂，貝爾德。

Hello, good morning. This is Chris on for Joel. Just a couple of questions on Symbravo. How are you thinking about that CGRP data in February in terms of are you going to pursue that in a new indication or a label expansion? And then is the plan still to pursue Symbravo, expand the label as well in adolescents? Thanks.

你好早安。這是克里斯代替喬爾。關於 Symbravo 我有幾個問題。您如何看待 2 月份的 CGRP 資料？您是否打算將其用於新的適應症或標籤擴展？那麼，是否仍計劃繼續推廣 Symbravo，並將其標籤擴展到青少年？謝謝。

Yes. Thanks, Chris, for the question. from the CGRP data in the EMERGE study, which we read out earlier this year. Obviously, it's a very compelling data. We've been able to share it in the market since we received it. And it is very clear that clinicians are motivated by that data as it gives them an additional place to try Symbravo once it's commercially available.

是的。謝謝克里斯提出的問題。來自我們今年早些時候讀過的 EMERGE 研究中 CGRP 數據。顯然，這是一個非常引人注目的數據。自從我們收到它以來，我們就能夠在市場上分享它。很明顯，這些數據激勵了臨床醫生，因為一旦 Symbravo 上市，他們就有更多機會嘗試該藥物。

At this time, we are not seeking to add it to the label as a new indication but we'll look to promote it through CSL guidance that the FDA puts forth and obviously, medical affairs team in medical education.

目前，我們並不打算將其作為新適應症添加到標籤中，但我們將尋求透過 FDA 提出的 CSL 指南以及醫學教育中的醫學事務團隊來推廣它。

I can take the last part on pediatric development. That work is underway as agreed to with the FDA. So stay tuned for updates there.

我可以承擔有關兒科發展的最後一部分。這項工作正在按照與 FDA 達成的協議進行。因此請繼續關注那裡的更新。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，瑞穗證券。

Hey, good morning. Congrats on the progress. Thanks for taking my question. Maybe just a bigger picture question on profitability or tantalizingly close to being a profitable company given where you are in cash and kind of where cash has evolved over the last several quarters. Just any comments on whether you do think that profitability can be achieved in 2025, at least on a quarter basis? Thanks.

嘿，早安。恭喜你取得進展。感謝您回答我的問題。考慮到貴公司的現金狀況以及過去幾季的現金變化情況，這或許只是一個關於獲利能力的更大問題，或者說，貴公司是否接近獲利。您是否認為 2025 年至少按季度可以實現盈利？謝謝。

Thanks, Graig. As you know, we haven't provided any guidance around timing, but we do remain confident we'll get the cash flow positivity with our current cash that is on hand. We expect to see, in 2025, leverage in our P&L, so a bit in Q1 already as sales growth is outpacing our operating expenses. And I think it's important we build Axsome on a very disciplined approach in how we're investing in our operations and how we allocate across our portfolio.

謝謝，格雷格。如您所知，我們尚未提供任何有關時間的指導，但我們仍然相信，憑藉我們現有的現金，我們將獲得正現金流。我們預計，到 2025 年，我們的損益表中將會出現槓桿，因此由於銷售成長超過了我們的營運支出，因此第一季就會出現一點槓桿。我認為，在建造 Axsome 時，我們必須採取非常嚴謹的方法，包括如何投資我們的營運以及如何在我們的投資組合中進行分配。

On the R&D side, the vast majority of our investment today is in our late-stage pipeline, late-stage programs and where we expect a high rate of return on that investment. And on the SG&A side, we've built significant infrastructure over the past three years, initially support Sunosi and Auvelity in now providing operating leverage as we launch Symbravo for future product launches. So we believe that we kind of summarized that the current cash will take us to cash flow positivity. We haven't given any specific guidance around profitability, but we feel like we're on the right course.

在研發方面，我們目前的投資絕大部分都投入了後期研發管線和後期專案中，我們預期這些投資將獲得較高的報酬率。在銷售、一般及行政費用方面，我們在過去三年中建立了重要的基礎設施，最初支援 Sunosi 和 Auvelity，現在在我們推出 Symbravo 以供未來產品發佈時提供營運槓桿。因此，我們相信，我們總結出目前的現金將使我們的現金流變為正數。我們還沒有給出任何有關盈利能力的具體指導，但我們覺得我們正走在正確的道路上。

And then maybe just as a quick follow-up, Nick, just on the evolution of your R&D and SG&A. R&D did come down relative to the fourth quarter. I don't know if you expect that to be sustained in terms of where R&D is right now. I would assume SG&A would tend to tick up higher, but just if you could provide your comments there would be appreciated. Thanks.

然後也許只是為了快速跟進一下，尼克，關於你的研發和銷售、一般及行政費用的演變。與第四季相比，研發費用確實有所下降。我不知道您是否認為目前的研發狀況能夠持續下去。我認為銷售、一般及行政費用 (SG&A) 會趨於上漲，但如果您能提供您的意見，我們將不勝感激。謝謝。

Thanks. Sure, yeah, you're right. R&D did tick down a bit from Q4. Three ADA trials were completed in Q4 and then the ADHD and MDD trials were completed mid-quarter in Q1. We would anticipate R&D spend to increase from the Q1 level as we initiate our second Phase III for solriamfetol in ADHD and MDD with EDS.

謝謝。當然，是的，你是對的。從第四季開始，研發支出確實有所下降。第四季完成了三項 ADA 試驗，第一季中期完成了 ADHD 和 MDD 試驗。隨著我們啟動針對患有 EDS 的 ADHD 和 MDD 的 solriamfetol 的第二階段 III 期臨床試驗，我們預計研發支出將從第一季開始增加。

Additionally, as a reminder, we did file the NDA for AXS-14 in Q2, so we will have that filing fee in Q2. And then as for SG&A, we do expect to see an increase versus Q1 as we complete our hiring for the Symbravo team, the Symbravo field team. We did have in Q1, a partial quarter of leadership team higher and Q2 will also include a partial quarter of the sales team for Symbravo. So we would anticipate that to tick higher in Q2. And then as Ari talked about, the DTC campaign later in the year, that will further increase SG&A.

此外，提醒一下，我們確實在第二季提交了 AXS-14 的保密協議 (NDA)，因此我們將在第二季支付該申請費。至於銷售、一般及行政費用，隨著我們完成 Symbravo 團隊和 Symbravo 現場團隊的招聘，我們確實預計與第一季相比銷售、一般及行政費用會有所增加。我們在第一季確實有部分領導團隊的增加，第二季還將包括 Symbravo 銷售團隊的部分增加。因此我們預計第二季這數字將會上升。然後，正如 Ari 談到的，今年稍後的 DTC 活動將進一步增加 SG&A。

Yatin Suneja, Guggenheim Partners.

蘇內賈 (Yatin Suneja)，古根漢合夥人事務所。

Hey guys, thank you for taking my question. My question is on the ADHD study that you had recently announced. Could you just talk about the path forward there? Also, I think at that time when you announced the data, there were some questions around the 300-milligram internal dose that we used. If you can just talk a little bit about why was that used from that 300-milligram dose going forward? So that's one.

嘿夥計們，謝謝你們回答我的問題。我的問題是關於您最近宣布的 ADHD 研究。您能談談未來的道路嗎？另外，我認為當您公佈數據時，人們對我們使用的 300 毫克內部劑量提出了一些疑問。您能否簡單談談為什麼從 300 毫克劑量開始就使用這種劑量？這就是其中之一。

And then the second one is on Auvelity in terms of the coverage there. I think it seems like some plateau in terms of the coverage, at least on the commercial side. Could you just talk about what is an ideal number to reach right now since like you are at about 60%, 65%? Thank you.

第二個是關於 Auvelity 的覆蓋範圍。我認為就覆蓋範圍而言似乎已經達到了某種穩定狀態，至少在商業方面是如此。您能否談談目前理想的數字應該達到多少，因為您目前已經達到了 60% 或 65% 左右？謝謝。

Yeah.

是的。

We'll start with the second question. We were having some difficulty hearing you on the first one, so maybe just clarify. But the -- regarding coverage, obviously, we've had -- this coverage has been stable over the last couple of quarters, but we have been actively negotiating and in communication with payers. And so we expect the access to expand and evolve this year.

我們從第二個問題開始。我們在聽清楚您的第一個問題時遇到了一些困難，所以也許需要澄清一下。但是，就覆蓋範圍而言，顯然我們已經有了——這種覆蓋範圍在過去幾個季度一直很穩定，但我們一直在積極與付款人談判和溝通。因此，我們預計今年的訪問管道將會擴大和發展。

In terms of ideal percent of covered lives, obviously, we want to secure as many covered lives as possible. There's not a specific number that we have in mind, just ultimately really focused on improving access for patients so that more patients have the opportunity for coverage with their health insurance plans.

就理想的受保生命百分比而言，顯然我們希望確保盡可能多的受保生命。我們並沒有想到一個具體的數字，只是最終真正專注於改善患者的就醫機會，以便更多患者有機會享受健康保險計劃的保障。

Great. And Yatin, as it relates to the first question for ADHD, the path forward is to initiate and complete the Phase III trial in pediatric patients. With regards to the adult study and the 300-milligram dose, as a reminder of the top dose, which is approved for solriamfetol is 150 milligrams per day.

偉大的。亞汀，由於這與 ADHD 的第一個問題有關，因此下一步的計劃是啟動並完成針對兒科患者的 III 期試驗。關於成人研究和 300 毫克劑量，需要提醒的是，solriamfetol 批准的最高劑量為每天 150 毫克。

Given that this was the first study that we're conducting in ADHD, we did want to look at a higher dose just to make sure that we define what those response was. Now the 150-milligram dose, that was primary dose of focus, that's the highest of good dose, very happy with the results of the study, which showed a very clear treatment effect for that dose.

鑑於這是我們在 ADHD 領域進行的首次研究，我們確實想研究更高的劑量，以確保我們能夠明確這些反應是什麼。現在 150 毫克的劑量是我們關注的主要劑量，也是最佳劑量，我對研究結果非常滿意，因為該劑量具有非常明顯的治療效果。

Thank you. You're addressing both my questions. Thanks.

謝謝。你回答了我的兩個問題。謝謝。

Myles Minter, William Blair.

邁爾斯·明特、威廉·布萊爾。

Hey, thanks for the questions. Congrats on the quarter. I think on May 24, we're expecting the Make America Healthy Again Commission to release an initial report on prevalence and threat of SSRIs antipsychotic mood stabilizers stimulants, kind of a catchall. And I think it's actually maybe focused on childhood disease.

嘿，謝謝你的提問。恭喜本季取得佳績。我認為，5 月 24 日，我們期待「讓美國再次健康」委員會發布一份關於 SSRI 類抗精神病藥物、情緒穩定劑和興奮劑的流行程度和威脅的初步報告，這是一種包羅萬象的報告。我認為它實際上可能關注的是兒童疾病。

But question is, if you had sort of any interaction with the commission on that report as it pertains to Auvelity or Sunosi? And I think they're going to finalize it in August. So do you expect to be able to comment on that one? That's the first question. The second is just on narcolepsy. I think a few of the other KOLs we've talked to are like, look, the efficacy for AXS-12 looks great on cataplexy.

但問題是，您是否與委員會就與 Auvelity 或 Sunosi 相關的報告進行任何互動？我認為他們將在八月完成此事。那麼您希望對此發表評論嗎？這是第一個問題。第二個是關於嗜睡症的。我想我們採訪過的其他一些 KOL 也認為，AXS-12 對猝倒症的療效很好。

There's some other symptoms that it looks interesting on as well. But in terms of the stimulant effects they're looking for like maintenance of wakefulness test. And I'm wondering whether you're going to have that data in the open-label extension? Thanks very much

還有一些其他症狀看起來也很有趣。但就興奮劑效果而言，他們正在尋找諸如維持清醒測試之類的效果。我想知道您是否會在開放標籤擴充功能中擁有這些資料？非常感謝

With regards to the first question, we have not had any interactions with the commission, and we're going to stay tuned, just like everybody else to see what the outcomes are as we state as we make sure that we keep an eye out and keep an ear out for anything that comes out that might affect the sector. As it relates to AXS-12, so with regards to the [BMWT], we have not incorporated BMWT our open-label trial. So however, we have looked at excessive sleepiness, as you know, using other measures including the clinical global impression of severity.

關於第一個問題，我們還沒有與委員會進行任何互動，我們將像其他人一樣繼續關注，看看結果如何，正如我們所說的那樣，我們確保密切關注並留意任何可能影響該行業的消息。由於它與 AXS-12 相關，因此就 [BMWT] 而言，我們尚未將 BMWT 納入我們的開放標籤測試。然而，如您所知，我們已經使用其他措施（包括嚴重程度的臨床整體印象）研究了過度嗜睡。

Right, thank you.

好的，謝謝。

Troy Langford, TD Cowen.

特洛伊·蘭福德 (Troy Langford)，考恩隊 (TD Cowen)。

Hi guys, thanks for taking our questions and congrats on all the progress this quarter. Just one on Sunosi and ADHD, just given the level of efficacy that we saw in the Phase III ADHD study not too long ago, do you have any reason to believe that the Phase III pediatric study will show a substantially different level of benefit? And then just a follow on to that, do you all have any expectations for approximately how long that pediatric study could take?

大家好，感謝您回答我們的問題，並祝賀本季取得的所有進展。僅就 Sunosi 和 ADHD 而言，鑑於我們不久前在 III 期 ADHD 研究中看到的療效水平，您是否有理由相信 III 期兒科研究將顯示出顯著不同的益處水平？然後我想問一下，你們對這項兒科研究大約需要多長時間有什麼預期嗎？

What we know is that historically, there's no correlation between efficacy for ADHD in adults as well as ADHD in pediatric subjects. So we like the fact that we have now seen a clear effect in adult population. However, we need to conduct the study in pediatric patients.

我們知道的是，從歷史上看，成人過動症的療效與兒童過動症的療效之間沒有相關性。因此，我們很高興看到，我們在成年人口中看到了明顯的效果。然而，我們需要對兒科患者進行這項研究。

And then in terms of how long it would take to enroll that study and conduct it is premature. So what we'll do is we'll provide some guidance, generally speaking, once we launched the study and talk about the exact design.

至於招募和進行這項研究需要多長時間，現在還為時過早。因此，一旦我們啟動研究並討論特定設計，我們通常會提供一些指導。

Ami Fadia, Needham & Company.

Ami Fadia，Needham & Company。

Hi, thanks for taking my question. Just maybe stepping back with a lot of your assets in late stage or in-market. Can you talk about how you're managing the business in terms of operating margins and investing across these various assets relative to also exploring potentially bringing in any additional assets? And how do we think about what would be sort of that return on investment decision that you make and then driving into kind of that path to profitability? Thank you.

你好，謝謝你回答我的問題。也許只是在後期或市場中放棄大量資產。您能否談談您是如何管理業務的營業利潤率和投資這些不同資產的，以及探索可能引入任何額外資產的？我們如何看待您所做的投資回報決策，然後將其推向獲利之路？謝謝。

Sure. Thanks, Ami. As I mentioned earlier in my comments, a lot of our focus, a lot of the R&D spend is on late-stage programs. And that has a high POS and a high rate of return. So we continue to invest in that. As I mentioned, R&D was slightly down for the quarter versus Q4, but continue to invest in developing those late-stage programs.

當然。謝謝，阿米。正如我之前在評論中提到的，我們的許多重點、許多研發支出都集中在後期專案上。並且具有較高的POS和較高的回報率。因此我們將繼續對此進行投資。正如我所提到的，本季的研發費用與第四季度相比略有下降，但仍在繼續投資開發這些後期項目。

And the infrastructure that we have built over the last three years, specifically starting with Sunosi and then with the launch of Auvelity, we're able to leverage that infrastructure on all of our future programs. So we believe that from that perspective, that those programs will have a higher ROI.

我們在過去三年中建立的基礎設施，特別是從 Sunosi 開始，然後是 Auvelity 的推出，我們能夠在所有未來的專案中利用這些基礎設施。因此，我們相信從這個角度來看，這些項目將具有更高的投資報酬率。

Thank you. 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.

謝謝。我們的問答環節已經結束。我想再次請大家發表進一步的評論或結束語。

Well, thank you all for taking the time to join today's call. As you've heard today, Axsome has accomplished a great deal in the first quarter. We are up to deliver another impactful year driven by strong commercial execution, we're rapidly expanding portfolio and multiple upcoming milestones. We appreciate your continued interest and support as we continue our work to bring innovative new treatment options to patients and create long-term value for our shareholders. Thank you very much.

好吧，感謝大家抽出時間參加今天的電話會議。正如大家今天所聽到的，Axsome 在第一季取得了巨大的成就。在強大的商業執行力、快速擴大的產品組合和即將到來的多個里程碑的推動下，我們將迎來另一個富有影響力的一年。我們感謝您一直以來的關注和支持，我們將繼續努力為患者帶來創新的治療選擇，並為我們的股東創造長期價值。非常感謝。

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

謝謝。今天的電話會議和網路直播到此結束。我們此時將斷開您的線路並祝您有美好的一天。我們感謝您今天的參與。