SAGE Therapeutics Inc (SAGE) 2025 Q1 法說會逐字稿

Good afternoon. Welcome to SAGE Therapeutics first quarter 2025 financial results conference call. (Operator Instructions). This call is being webcast live on the investors and media section of Sage's website at sagerx.com. This call is the property of SAGE Therapeutics and recording, reproduction, or transmission of this call without the express written consent of SAGE Therapeutics is strictly prohibited. Please note that this call is being recorded.

午安.歡迎參加 SAGE Therapeutics 2025 年第一季財務業績電話會議。（操作員指令）。本次電話會議將在 Sage 網站 sagerx.com 的投資者和媒體部分進行網路直播。本次通話是 SAGE Therapeutics 的財產，未經 SAGE Therapeutics 明確書面同意，嚴禁錄製、複製或傳輸本次通話。請注意，本次通話正在錄音。

I would now like to introduce Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at SAGE.

現在我想介紹 SAGE 投資者關係和資本市場副總裁 Ashley Kaplowitz。

Good afternoon and thank you for joining SAGE Therapeutics first quarter 2025 financial results conference call. Before we begin, I encourage everyone to go to the investors and media section of our website at sagerx.com, where you can find the press release and slides related to today's call.

下午好，感謝您參加 SAGE Therapeutics 2025 年第一季財務業績電話會議。在我們開始之前，我鼓勵大家造訪我們網站 sagerx.com 的投資者和媒體部分，在那裡您可以找到與今天的電話會議相關的新聞稿和幻燈片。

I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional details.

我想指出的是，我們將根據我們目前的預期和信念做出前瞻性的陳述。這些聲明受一定風險和不確定性的影響，我們的實際結果可能有重大差異。請查看今天的新聞稿和我們的美國證券交易委員會文件中討論的風險因素以獲取更多詳細資訊。

We will begin the call with prepared remarks by Barry Greene, our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2025. Our Chief Operating Officer, Chris Benecchi, will provide an update on the ongoing commercialization of ZURZUVAE and key financial results from the first quarter of 2025. Our Chief Scientific Officer and Interim Head of R&D, Mike Quirk, will then provide a brief update on our pipeline.

我們的執行長 Barry Greene 將首先發表準備好的講話，概述我們在 2025 年第一季取得的進展。我們的營運長 Chris Benecchi 將提供有關 ZURZUVAE 正在進行的商業化進展以及 2025 年第一季主要財務業績的最新資訊。我們的首席科學長兼臨時研發主管 Mike Quirk 將簡要介紹我們的產品線。

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

說完這些，我現在將電話轉給巴里。

Thanks, Ashley, and thank you everyone for joining us this afternoon. We had a strong start to 2025 as we advanced our commercialization efforts for ZURZUVAE, the first and only oral treatment approved for adults with postpartum depression or PPD, and we also are strategically progressing our refocused pipeline. Now before I get into detail, I wanted to briefly address an important initiative.

謝謝，阿什利，也謝謝大家今天下午加入我們。2025 年，我們有一個良好的開端，我們推進了 ZURZUVAE 的商業化努力，ZURZUVAE 是首個也是唯一一個獲準用於治療產後憂鬱症或 PPD 成人患者的口服治療藥物，而且我們也在策略性地推進我們重新聚焦的產品線。現在，在我詳細介紹之前，我想先簡單談談一項重要舉措。

The SAGE Board of Directors continues to advance its strategic alternatives process. As we previously noted, SAGE is conducting a comprehensive process to evaluate a broad range of opportunities for the company to maximize value for shareholders. The review process remains ongoing. We've not set a timetable for the review process and do not intend to disclose further developments until we determine that disclosure is appropriate or necessary.

SAGE 董事會持續推進其策略性替代流程。正如我們之前提到的，SAGE 正在進行一項全面的流程來評估公司為股東實現價值最大化的廣泛機會。審查過程仍在進行中。我們尚未設定審查過程的時間表，並且在我們確定披露是適當或必要的之前，不打算披露進一步的進展。

Now turning back to ZURZUVAE, we continue to be energized by the profound impact we're having on women with PPD and are driving our efforts forward to bring ZURZUVAE to more women suffering from this urgent medical condition. In the first quarter of 2025, ZURZUVAE was shipped to greater than 3,000 women with PPD.

現在回到 ZURZUVAE，我們繼續為患有 PPD 女性所產生的深遠影響而感到振奮，並正在努力將 ZURZUVAE 帶給更多患有這種緊急疾病的女性。2025 年第一季度，ZURZUVAE 已交付給超過 3,000 名患有 PPD 的女性。

That represents a 22% increase from the fourth quarter of 2024. We generated $13.8 million in collaboration revenue for ZURZUVAE in the first quarter, which represents 50% of the net revenue recorded by Biogen, a 21% increase in the fourth quarter of 2024. Importantly, we are starting to see signs of a system-wide paradigm shift in the way healthcare providers, specifically OBGYNs, are increasingly screening, diagnosing, and treating PPD.

這比 2024 年第四季成長了 22%。我們在第一季為 ZURZUVAE 創造了 1,380 萬美元的合作收入，佔 Biogen 淨收入的 50%，比 2024 年第四季成長了 21%。重要的是，我們開始看到醫療保健提供者（特別是婦產科醫生）在篩檢、診斷和治療 PPD 方面發生系統性範式轉變的跡象。

We believe that enhanced screening, diagnosis, and treatment paired with the continued elevated national dialogue around maternal mental health are critical to accelerating growth in PPD. In fact, as of today, I'm pleased to share that we've reached a significant milestone in advancing patient care. Since launch, we've shipped ZURZUVAE to greater than 10,000 women with PPD.

我們相信，加強篩檢、診斷和治療，並持續加強產婦心理健康的全國性對話，對於加速產後憂鬱症的成長至關重要。事實上，截至今天，我很高興地告訴大家，我們在推動病患照護方面已經取得了重要的里程碑。自推出以來，我們已向超過 10,000 名患有 PPD 的女性運送了 ZURZUVAE。

We remain focused on our goal of establishing ZURZUVAE as the standard of care for women with PPD. And with our continued progress, we believe we're making advancements toward that goal. In addition to executing on our launch, we also continue to make progress on our pipeline. Last year we recalibrated our R&D approach, and we significantly reduced our cost structure, aligning our resources around the areas that we believe have the greatest potential for value creation.

我們始終專注於將 ZURZUVAE 確立為產後憂鬱症女性照護的標準。隨著我們不斷進步，我們相信我們正在朝著這個目標邁進。除了執行我們的發布計劃之外，我們還繼續在我們的管道上取得進展。去年，我們重新調整了研發方法，大幅降低了成本結構，將資源集中在我們認為最有價值創造潛力的領域。

As a result of this work, we prioritize our clinical pipeline in neuropsychiatry and neurodevelopmental disorders, where we see strong scientific rationale and believe a significant unmet need exists. Specifically, we're excited about the potential opportunities for both SAGE-319 and our NMDA receptor NAM platform, which we believe could add significant value for shareholders and patients if our development efforts are successful.

由於這項工作，我們優先考慮神經精神病學和神經發育障礙的臨床研究，我們看到了強有力的科學原理，並相信存在著重大的未滿足需求。具體來說，我們對 SAGE-319 和我們的 NMDA 受體 NAM 平台的潛在機會感到興奮，我們相信，如果我們的開發工作成功，它們可以為股東和患者增加巨大的價值。

We also continue to evaluate next steps for SAGE-324. Mike will provide additional details on these programs. As we previously shared, Mike was appointed interim head of R&D and is leading the team forward. I'm confident in the continuity and execution of our clinical priorities under his leadership. With the commercial momentum of ZURZUVAE and PPD, our focused R&D approach, and cash runway expected to support operations to mid-2027, we believe we are well positioned toward our goal of creating value for our shareholders.

我們也將繼續評估 SAGE-324 的後續步驟。麥克將提供有關這些計劃的更多詳細資訊。正如我們之前所分享的，Mike 被任命為臨時研發主管並帶領團隊前進。我相信在他的領導下，我們的臨床重點工作能夠連續並執行。憑藉 ZURZUVAE 和 PPD 的商業發展勢頭、我們專注的研發方法以及預計支援到 2027 年中期營運的現金流，我們相信我們已做好準備，實現為股東創造價值的目標。

I'll now turn the call over to Chris to discuss ZURZUVAE and our financial performance for the quarter. Chris?

現在我將把電話轉給克里斯，討論 ZURZUVAE 和我們本季的財務表現。克里斯？

Thanks, Barry. I'll begin with an update on our ZURZUVAE commercialization progress, ongoing initiatives to maximize reach to women with PPD and conclude with our financials for the first quarter of 2025. As Barry noted, we are off to a strong start this year as demand for ZURZUVAE and the treatment of women with PPD continue to grow.

謝謝，巴里。我將首先介紹我們的 ZURZUVAE 商業化進展、為最大程度覆蓋患有 PPD 的女性而採取的持續舉措，最後介紹我們 2025 年第一季的財務狀況。正如 Barry 所指出的，由於對 ZURZUVAE 和患有 PPD 的女性治療的需求持續增長，我們今年開局良好。

In the first quarter of 2025, we shipped greater than 3,000 prescriptions representing a 22% increase from the fourth quarter of 2024. We continue to see greater than 70% of women prescribed ZURZUVAE receive it as their first new treatment for PPD, which we believe shows the potential for ZURZUVAE to become the standard of care for this urgent medical condition.

2025 年第一季度，我們發送了超過 3,000 張處方，比 2024 年第四季增加了 22%。我們持續看到超過 70% 接受 ZURZUVAE 處方的女性將其作為她們治療 PPD 的首個新療法，我們相信這表明 ZURZUVAE 有可能成為這種緊急醫療狀況的標準治療方法。

In terms of prescriber trends in the first quarter, almost 80% of prescriptions came from OBGYNs, who were at the forefront of peripartum care, the most critical time to screen, diagnose, and treat PPD. In addition to OBGYNs, we saw the balance of prescriptions come from a mix of psychiatrists and PCPs. As we've expanded our promotional efforts, including through the recent Salesforce expansions, we believe that utilization of ZURZUVAE will continue to increase among these physician types.

從第一季的處方趨勢來看，近 80% 的處方來自婦產科醫生，她們處於圍產期護理的最前線，而圍產期是篩檢、診斷和治療 PPD 的最關鍵時期。除了婦產科醫生之外，我們還發現處方平衡來自精神科醫生和初級保健醫生。隨著我們擴大推廣力度，包括透過最近的 Salesforce 擴展，我們相信 ZURZUVAE 在這些醫生類型的使用率將繼續增加。

Further, we continue to see strong overall prescribing trends with ongoing broader adoption of ZURZUVAE. Totals of ZURZUVAE writers increased by greater than 20% in Q1. And we continued to observe that once an HCP writes, there is strong repeat prescribing. Importantly, we are seeing that once an OBGYNs has prescribed ZURZUVAE, there is a significant increase in the number of women with PPD they treat based on prescriptions for all medications.

此外，隨著 ZURZUVAE 的持續廣泛採用，我們繼續看到強勁的整體處方趨勢。第一季度，ZURZUVAE 作家總數增加了 20% 以上。我們繼續觀察發現，一旦 HCP 開出處方，就會出現大量重複開藥的情況。重要的是，我們發現，一旦婦產科醫生開了 ZURZUVAE，根據所有藥物的處方，他們治療的患有 PPD 的女性數量就會顯著增加。

At the beginning of the year, we announced a robust investment plan intended to help accelerate the launch of ZURZUVAE, which included a joint salesforce expansion to broaden our reach of healthcare providers who treat PPD. Investments in media opportunities to further communicate the ZURZUVAE brand value proposition and amplify the message that PPD is an urgent medical condition. And increased visibility via social media to support PPD awareness and educational efforts.

今年年初，我們宣布了一項強有力的投資計劃，旨在幫助加速 ZURZUVAE 的推出，其中包括聯合銷售團隊擴張，以擴大我們治療 PPD 的醫療保健提供者的覆蓋範圍。投資媒體機會，進一步傳達 ZURZUVAE 品牌價值主張，並擴大 PPD 是一種緊急醫療狀況的訊息。並透過社群媒體提高知名度，以支持 PPD 意識和教育工作。

In the first quarter we made significant progress in these areas. Our recent sales force expansion is now complete with our initial expansion in the fourth quarter of 2024, followed by additions in the first quarter. Following our launch of consumer social media at the end of 2024, we saw greater than 65 million video views across Meta and TikTok.

第一季我們在這些領域取得了重大進展。我們最近的銷售隊伍擴張現已完成，首次擴張將於 2024 年第四季進行，隨後在第一季進行擴充。繼 2024 年底推出消費者社群媒體後，我們在 Meta 和 TikTok 上的影片觀看次數已超過 6,500 萬次。

And at the beginning of April, we launched our first HCP social media campaign, which deepens our engagement with HCPs and advances efforts to build awareness of ZURZUVAE in PPD. We are pleased with the progress made to date and anticipate that our investments this year will help support our goal of significant top line revenue growth in 2025.

4 月初，我們啟動了首個 HCP 社群媒體活動，加深了我們與 HCP 的互動，並進一步努力提高人們對 PPD 患者 ZURZUVAE 的認識。我們對迄今為止的進展感到滿意，並預計今年的投資將有助於支持我們實現 2025 年大幅增加營業收入的目標。

We look forward to sharing additional updates in the coming quarters. Now turning to our financial results for the first quarter of 2025. As a reminder, our full financial results for this period are detailed in our press release issued this afternoon with further details in our 10-Q.

我們期待在未來幾季分享更多更新。現在來看看我們 2025 年第一季的財務表現。提醒一下，我們此期間的完整財務業績已在今天下午發布的新聞稿中詳細說明，更多詳細資訊請參閱我們的 10-Q 報告。

We reported collaboration revenue from the sale of ZURZUVAE of $13.8 million in the first quarter. A 21% increase compared to the fourth quarter of 2024. As a reminder, our reported collaboration revenue is 50% of the net revenue Biogen reports for ZURZUVAE. R&D expenses were $22.8 million and SG&A expenses were $57.6 million in the first quarter of 2025.

我們報告稱，第一季出售 ZURZUVAE 的合作收入為 1,380 萬美元。與 2024 年第四季相比成長了 21%。提醒一下，我們報告的合作收入是 Biogen 報告的 ZURZUVAE 淨收入的 50%。2025 年第一季研發費用為 2,280 萬美元，銷售、一般及行政費用為 5,760 萬美元。

SAGE underwent a reorganization late last year designed to right size the company to support the ongoing launch of ZURZUVAE and our focused pipeline development efforts. R&D expenses were significantly reduced as a result of the restructuring. You'll see that reflected in the decrease of our R&D expenses by 68% in Q1 2025 as compared to the same period in 2024.

SAGE 於去年年底進行了重組，旨在調整公司規模，以支援 ZURZUVAE 的持續推出和我們重點關注的管道開發工作。重組後，研發費用大幅減少。您會發現，與 2024 年同期相比，2025 年第一季我們的研發費用減少了 68%。

Further, last quarter we said we expected the first full quarter of savings from the reorganization to be realized in Q1 2025. An example of those cost savings is the nearly 40% decrease in R&D expenses in Q1 2025 as compared to Q4 2024. As we noted previously, while we expect ZURZUVAE joint commercialization investment to increase in 2025, we anticipate overall operating expenses will substantially decrease in 2025 relative to 2024.

此外，上個季度我們表示，預計重組帶來的第一季節省將在 2025 年第一季實現。成本節約的一個例子是，2025 年第一季的研發費用與 2024 年第四季相比減少了近 40%。正如我們之前提到的，雖然我們預計 ZURZUVAE 聯合商業化投資將在 2025 年增加，但我們預計 2025 年的整體營運費用將相對於 2024 年大幅下降。

We continue to be very diligent with our investments aimed at creating shareholder value. Our net loss for the first quarter of 2025 was $62.2 million as compared to our net loss for the fourth quarter of 2024, which was $95.8 million, illustrating SAGE's continued efforts to streamline business operations. Based upon our current operating plan, we anticipate that our existing cash equivalents, and marketable securities of $424 million as of March 31, 2025, together with anticipated funding from ongoing collaborations and estimated revenues and excluding any potential milestone payments we may receive under our collaboration agreements, will support our operations to mid-2027.

我們將繼續勤勉地進行投資，以創造股東價值。我們 2025 年第一季的淨虧損為 6,220 萬美元，而 2024 年第四季的淨虧損為 9,580 萬美元，這表明 SAGE 正在不斷努力簡化業務營運。根據我們目前的營運計劃，我們預計截至 2025 年 3 月 31 日的現有現金等價物和 4.24 億美元的有價證券，加上預期來自持續合作的資金和預計收入（不包括我們根據合作協議可能收到的任何潛在里程碑付款），將支持我們運營到 2027 年中期。

With that, I'll turn the call over to Mike to provide an update on our pipeline. Mike?

說完這些，我將把電話轉給麥克，讓他提供有關我們管道的最新情況。麥克風？

Thanks, Chris. As Barry noted earlier, we remained focused on developing medicines for Neuropsychiatry and neurodevelopmental disorders, where we see a strong scientific rationale and believe an unmet need exists.

謝謝，克里斯。正如巴里之前提到的，我們仍然專注於開發治療神經精神病學和神經發育障礙的藥物，我們看到了強有力的科學原理，並相信存在未滿足的需求。

I'll begin with SAGE-319, our wholly owned extra synaptic preferring GAAA receptor positive allosteric modulator, or PAM, which was designed to have novel pharmacology and a differentiated profile from other GABA receptor PAM in our portfolio. Our goal with SAGE-319 is to demonstrate meaningful clinical effect. And a product profile that is differentiated by a broader therapeutic index given the preferential modulation of extra synaptic GABA A receptors.

我將從 SAGE-319 開始，這是我們全資擁有的突觸外偏好 GAAA 受體正變構調節劑（PAM），其設計具有新穎的藥理學特性，並且與我們產品組合中的其他 GABA 受體 PAM 具有區別。我們對 SAGE-319 的目標是展示有意義的臨床效果。由於優先調節突觸外 GABA A 受體，該產品具有更廣泛的治療指數。

SAGE-319 is currently being investigated as a potential treatment for behavioral symptoms associated with certain neurodevelopmental disorders, which could include autism spectrum disorder, Tourette's, and other rare neurological disorders, all of which are known to have high burdens on patients, families, and the healthcare system.

SAGE-319 目前正在被研究作為治療與某些神經發育障礙相關的行為症狀的潛在方法，這些障礙可能包括自閉症譜系障礙、圖雷特氏症和其他罕見的神經系統疾病，所有這些疾病都給患者、家庭和醫療保健系統帶來沉重的負擔。

We expect to share data from the phase one Multiple Ascending Dose or MAD study by late 2025 and anticipate that the upcoming results from this study could enable potential studies in a patient population in early 2026. Further, we have two orally administered NMDA receptor negative allosteric modulators, or NAMs in pre-clinical development.

我們預計在 2025 年底前分享第一階段多次遞增劑量或 MAD 研究的數據，並預計該研究即將得出的結果可在 2026 年初對患者群體進行潛在研究。此外，我們還有兩種口服 NMDA 受體負變構調節劑（NAM）處於臨床前開發階段。

SAGE-817 and SAGE-039. Our intention with these drug candidates is to develop a drug with similar or better efficacy than NMDA receptor blockers like ketamine, but with a potentially improved safety and tolerability profile. SAGE-817 and SAGE-039 have distinct preclinical profiles with a SAGE-817 inhibiting a broad array of NMDA receptor subtypes and showing stronger inhibition, whereas Sage-039 exhibits subtype specificity and has more limited inhibition.

SAGE-817 和 SAGE-039。我們對這些候選藥物的目的是開發一種與氯胺酮等 NMDA 受體阻斷劑具有相似或更好療效的藥物，但具有潛在的更好的安全性和耐受性。SAGE-817 和 SAGE-039 具有不同的臨床前特徵，其中 SAGE-817 抑制多種 NMDA 受體亞型並表現出更強的抑製作用，而 SAGE-039 表現出亞型特異性並且抑製作用較有限。

We are also exploring SAGE-324, our wholly owned GABA receptoram for various potential indications, including seizures in developmental and epileptic encephalopathies, or DEEs. We expect to provide an update on next steps, if any, in mid-2025. To be clear, we are not spending developmental dollars on SAGE-324, but rather, we are evaluating SAGE-324 as part of an overall portfolio decision.

我們也正在探索 SAGE-324（我們全資擁有的 GABA 受體），用於治療各種潛在適應症，包括發育性和癲癇性腦病變（DEE）中的癲癇發作。我們預計將在 2025 年中期提供有關後續步驟的最新資訊（如果有）。需要明確的是，我們不會在 SAGE-324 上花費開發資金，而是將 SAGE-324 作為整體投資組合決策的一部分進行評估。

We remain excited about opportunities to bring forward developmental candidates from our deep reservoir of proprietary compounds that target the GABA and NMDA receptor systems. While many of these activities are ongoing in the background, we look forward to sharing updates on our progress with you in due course.

我們仍然對從我們豐富的專有化合物庫中推出針對 GABA 和 NMDA 受體系統的開發候選藥物的機會感到興奮。雖然其中許多活動仍在幕後進行，但我們期待在適當的時候與您分享我們的進展。

With that, I will turn it over to Ashley to help facilitate the Q&A portion of today's conference call. Ashley?

接下來，我將把時間交給 Ashley，讓她幫忙主持今天電話會議的問答部分。阿什利？

Thanks, Mike. As a reminder, we will not be answering questions related to the strategic alternatives process and ask that question to be focused on our first quarter 2025 results. Please limit yourself to one question. If you have an additional question, feel free to return to the queue. Now I'll turn the call over to the operator to handle Q&A operator.

謝謝，麥克。提醒一下，我們不會回答與策略替代流程相關的問題，並要求該問題集中在我們的 2025 年第一季業績上。請限制自己只問一個問題。如果您還有其他問題，請隨時返回佇列。現在我將把電話轉給負責問答的接線生。

(Operator Instructions) Malcolm Smith, J.P. Morgan.

（操作員指示）馬爾科姆史密斯，J.P. 摩根。

Hi, thanks for taking the question. This is actually a Malcolm Cuno on for Anupam Rama. What kind of early pull through are you seeing from your, salesforce initiatives?

你好，謝謝你回答這個問題。這實際上是馬爾科姆·庫諾 (Malcolm Cuno) 為阿努帕姆·拉瑪 (Anupam Rama) 表演的。您從銷售團隊計畫中看到了什麼樣的早期成效？

Hey, Malcolm, yes, I'll start. I'll ask Chris to comment. As you saw, we had a really strong first quarter of the year with over 20% growth both in demand and revenue. As a reminder of both companies expanded the sales force in the first quarter. That is complete. And what we believe is that we'll continue to see quarter-on-quarter revenue growth throughout the remainder of the year.

嘿，馬爾科姆，是的，我先開始了。我會請克里斯發表評論。如您所見，今年第一季我們的表現非常強勁，需求和收入均成長了 20% 以上。值得一提的是，兩家公司都在第一季擴大了銷售團隊。這就完成了。我們相信，今年剩餘時間內我們將繼續看到季度環比營收成長。

Yes, what I would add is when we made the decision strategically to expand the sales organization first in the fourth quarter of last year and again beginning this year. But we wanted to do is we wanted to broaden our reach and increase the frequency associated with the contacts that we were having with healthcare professionals.

是的，我想補充的是，我們在去年第四季首次做出了擴大銷售組織的策略決策，今年年初再次做出擴大銷售組織的策略決策。但我們想要做的是擴大我們的覆蓋範圍並增加與醫療保健專業人士聯繫的頻率。

And the implications of that have been that OBGYNs have really seen. A significant portion of our activity and in fact with 80% of prescriptions coming from OBGYNs, we really are doing a lot of work to make sure that there is an activated prescriber base on the front line of peripartum care who are engaged and prepared to not only prescribe ZURZUVAE, but to, in effect, broaden the screening process and the diagnosis of PPD, which is really exciting.

其意義是婦產科醫生確實已經看到了。我們活動的很大一部分（事實上 80% 的處方來自婦產科醫生）確實在做大量工作，以確保在圍產期護理的第一線有一個活躍的處方者基礎，他們不僅參與並準備開出 ZURZUVAE，而且實際上擴大了篩檢過程和 PPD 的診斷，這確實令人興奮。

It's always important to have that kind of foundation. So we've really focused in the sales force on OBGYNs and really capitalizing on that as an opportunity as we go forward.

擁有這樣的基礎總是很重要的。因此，我們真正專注於婦產科的銷售隊伍，並真正利用這個機會向前發展。

Great. Thank you.

偉大的。謝謝。

Shrunatra Mishra, Goldman Sachs.

高盛的 Shrunatra Mishra。

Hi, this is Shrunatra on for Salveen. Could you provide some additional color on the pipeline and your upcoming catalysts. And particularly what is driving SAGE's confidence in the GABA and NMDAR pathways, given the setbacks on the pipeline that we saw last year.

大家好，我是 Salveen 的 Shrunatra。您能否提供一些有關管道和即將推出的催化劑的額外資訊。鑑於我們去年看到的管道挫折，是什麼促使 SAGE 對 GABA 和 NMDAR 途徑充滿信心。

Thanks for your question. I'll start and I'll ask Mike to comment. So as we talked about earlier in the year, we recalibrated R&D approach and really focused our pipeline. We believe that we are now pursuing drugs with the pharmacology appropriate for indication we're pursuing that SAGE through or not. And we're also valid, we're also focused with our NMDAs on very validated targets.

謝謝你的提問。我先開始，然後請麥克發表評論。正如我們今年早些時候談到的那樣，我們重新調整了研發方法並真正集中了我們的研發管線。我們相信，我們現在正在尋求適合適應症的藥理學藥物，無論是否透過 SAGE 我們都在尋求這種藥物。而且我們也是有效的，我們也專注於我們的 NMDA 經過驗證的目標。

So we feel very good about the drugs that we have, the pharmacology that we have, and the indications that go that go after. We believe that if successful, we'll create major shareholder value, as well, of course, patient impact. Mike, you want to talk a little bit more about that?

因此，我們對我們擁有的藥物、我們擁有的藥理學以及所追求的適應症感到非常滿意。我們相信，如果成功的話，我們將創造主要股東價值，當然也會對患者產生影響。麥克，你想進一步談談這個嗎？

If I could just add on to a little bit of that. I mean, -- I think there are two elements of our recalibrate approach. One is the areas of disease biology that we're focused on and really prioritizing neuropsychiatry and neurodevelopment disorders where we think there's a very strong biological rationale for both SAGE-319 or synaptic preferring GABA positive allosteric modulator as well as for NMDA receptor NAM platform.

如果我可以再補充一點的話。我的意思是──我認為我們的重新調整方法有兩個要素。一個是我們關注的疾病生物學領域，我們真正優先考慮神經精神病學和神經發育障礙，我們認為 SAGE-319 或突觸偏好 GABA 正變構調節劑以及 NMDA 受體 NAM 平台都有非常強大的生物學原理。

And second, by also looking at those indications where we think that there are feasible regulatory pathways. And across both of these programs, 319 and the NMDAR, NAM platform, as Barry mentioned, one of the key elements that we're looking at is making sure that we leverage clinical insights and clinical validations as much as possible.

其次，也要觀察那些我們認為有可行監管途徑的跡象。正如 Barry 所提到的，在 319 和 NMDAR、NAM 平台這兩個項目中，我們關注的關鍵要素之一是確保盡可能多地利用臨床見解和臨床驗證。

So for example, with NMDAR receptor NAMs, we know that negative modulation or inhibition of NMDAR receptors is a very valid target in areas of neuropsychiatry and neurodevelopment disorders with molecules such as ketamine and Memantine. The key differences with our NAMs, we believe that we'll be able to provide a similar or better therapeutic efficacy as open channel blockers, but with an improved tolerability profile.

例如，對於 NMDAR 受體 NAM，我們知道使用氯胺酮和美金剛等分子對 NMDAR 受體進行負向調節或抑制是神經精神病學和神經發育障礙領域中非常有效的目標。與我們的 NAM 的主要區別在於，我們相信我們能夠提供與開放通道阻斷劑相似或更好的治療效果，但具有更好的耐受性。

So again, really leaning into the clinical insights that we can derive across our programs. And similarly with SAGE-319 being a differentiated extra synaptic preferring PAM, we're able to leverage a lot of our own learnings as well as learning from others and being able to have a lot of the efficacy signals that we've seen in various indications, but also potentially have an improved tolerability profile by specifically modulating the extra synaptic components of the GABA system.

因此，我們再次真正傾向於從我們的計畫中獲得的臨床見解。同樣，由於 SAGE-319 是一種差異化的突觸外偏好 PAM，我們能夠利用自己的大量知識以及向他人學習的經驗，並能夠獲得我們在各種適應症中看到的大量療效信號，但也可能透過專門調節 GABA 系統的突觸外成分來改善耐受性。

Thanks, Mike. Thanks, Laura.

謝謝，麥克。謝謝，勞拉。

Morgan Gryga, Morgan Stanley

摩根‧格里加，摩根士丹利

Hi, this is Morgan Gryga on for Vikram. Thanks for taking our question. So on ZURZUVAE for those prescribers and patients deciding not to use ZURZUVAE as their first line treatment. What do you believe are the key factors as to why? And which efforts do you have underway that you think are likely to be key to addressing these reasons?

大家好，我是 Morgan Gryga，為 Vikram 報道。感謝您回答我們的問題。因此，對於那些決定不將 ZURZUVAE 作為第一線治療的開藥者和患者來說，ZURZUVAE 是最佳選擇。您認為造成這現象的關鍵因素是什麼？您認為您正在採取哪些措施可能成為解決這些問題的關鍵？

And then second question. Could you speak about the concentrations of the salesforce in particular regions? I know in the last update you had said in the regions where the salesforce had been expanded, you had seen, I believe it was a 33% uplift. Could you provide any color details there on updates and how that's panning out? Thank you.

然後是第二個問題。能談談特定地區的銷售人員集中情況嗎？我知道在上次更新中您說過，在銷售隊伍擴大的地區，我相信成長了 33%。您能否提供有關更新的詳細資訊以及進展？謝謝。

Yes, Morgan, thanks for the questions. So let me answer the second first. I, as we said, both companies are now complete, have completed their expansion in the first quarter. With that expansion complete, we believe that we're going to see a quarter-to-quarter growth in the in the foreseeable future. So that's really all we can comment about on the salesforces, as Chris said earlier, our reach is greater to more OBGYNs and in this quarter, we saw a significant number of new writers.

是的，摩根，謝謝你的提問。那麼讓我先回答第二個問題。正如我們所說，兩家公司現在都已完成，並在第一季完成了擴張。隨著擴張的完成，我們相信在可預見的未來我們將看到季度環比成長。這就是我們對銷售人員所能評論的全部內容，正如克里斯之前所說，我們的覆蓋範圍擴大到更多的婦產科醫生，並且在本季度，我們看到了大量的新作家。

And we continue to bring new writers on every quarter. And as you heard from Chris earlier, those new writers become repeat writers as new writers come on. So that's the trend we're seeing. In terms of ZURZUVAE, more than 70% of women prescribed ZURZUVAE are receiving it as their first new treatment for PPD.

我們每季都會繼續引進新的作家。正如你之前從克里斯那裡聽到的，隨著新作家的出現，那些新作家也成為了重複作家。這就是我們所看到的趨勢。就 ZURZUVAE 而言，超過 70% 接受 ZURZUVAE 處方的女性將其作為她們治療 PPD 的首個新療法。

So about a year and so, that's quite a remarkable number. We really don't see obstacles to Zubi becoming a front line, the frontline use.

大約一年左右的時間，這是一個相當了不起的數字。我們確實沒有看到 Zubi 成為前線、前線使用的障礙。

Okay. Thank you.

好的。謝謝。

Athena Chin, TD Cowen

雅典娜陳（Athena Chin），TD Cowen

Hi guys, this is Athena on for Ritu Baral. Thanks for taking the question. During the last earnings calls, you guys noted that inventory levels for ZURZUVAE were kind of fluid. So how should we, look at these levels now and when can we expect them to stabilize? Thank you.

大家好，我是 Ritu Baral 的 Athena。感謝您回答這個問題。在上次財報電話會議上，你們注意到 ZURZUVAE 的庫存水準有點不穩定。那麼我們現在應該如何看待這些水平以及何時可以預期它們會穩定下來？謝謝。

Thanks, Athena. Let me ask Chris to talk about the inventory.

謝謝，雅典娜。讓我請克里斯談談庫存問題。

Yes. So what I can say is that inventory varies from quarter to quarter as wholesalers apply their various purchasing habits associated with inventory. So it's tough to peg inventory as it fluctuates up and down. What's most Important is to really look at demand here and demand is measured by shipments from specialty pharmacies directly to women with PPD.

是的。因此我可以說的是，由於批發商採用與庫存相關的各種採購習慣，庫存每季都會有所不同。因此，由於庫存會上下波動，因此很難將其控制住。最重要的是真正關注需求，而需求是透過從專科藥房直接向患有 PPD 的女性發貨來衡量的。

Which is why we're so encouraged by the more than 3,000 shipments that went through in the first quarter of 2025 as reflective of the uptake, the interest in ZURZUVAE and the uptake of the medication early in the launch. So again, I would direct you to focusing on the demand rather than the inventory fluctuations over a period.

這就是為什麼我們對 2025 年第一季超過 3,000 批的發貨量感到如此鼓舞，因為這反映了 ZURZUVAE 的吸收、人們對其的興趣以及該藥物在上市初期的吸收。因此，我再次建議您專注於需求，而不是一段時間內的庫存波動。

Paul Matteis, Stifel.

保羅·馬泰斯（Paul Matteis），Stifel。

Hey, this is Julian on call. Thanks so much for taking my question. I know first quarter, tends to be a little bit difficult to understand, read through on to the rest of the year. But I guess I'm thinking about what you guys are seeing in demand, so far for 2Q. And I guess are you expecting sort of a re-acceleration in growth and I guess were you surprised by, the somewhat, flat quarter-over-quarter shipments you saw from 4Q.

嘿，我是朱利安，值班。非常感謝您回答我的問題。我知道第一季往往有點難以理解，請繼續閱讀今年剩餘的時間。但我想我正在考慮你們到目前為止對第二季度的需求是什麼。我想您是否期待成長的再次加速？我想您是否對第四季環比出貨量持平感到驚訝？

Julian, thanks for the question. Well, we actually didn't see a flat quarter. We saw an over 20% growth from the fourth quarter to the first quarter in both demand and revenue. So we're excited by that. And I can't really comment on how the second quarter has started other otherwise other say what we said before, which is, and we said this in January. We see quarter to quarter growth throughout each quarter of this year and pretty confident in that statement.

朱利安，謝謝你的提問。嗯，我們實際上並沒有看到一個平穩的季度。我們看到，從第四季度到第一季度，需求和收入都增加了 20% 以上。我們對此感到很興奮。我無法真正評論第二季度的開局如何，否則，其他人會說我們之前說過的話，也就是我們在一月份說過的話。我們看到今年每個季度都實現了環比增長，我們對這一說法非常有信心。

Ami Fadia, Needham & Co.

Ami Fadia，Needham＆Co.

Hi, good afternoon. Thanks for taking my question. Just a quick follow up to the previous question, As we think about the expansion and the commercial efforts by both yourself and Biogen. How should we think about kind of the acceleration in growth, in these sort of shipments, as the quarters progress. Maybe if you could sort of help us sort of get some sort of a sizing of by how much you've expanded the efforts.

嗨，下午好。感謝您回答我的問題。我只是想快速跟進一下上一個問題，我們考慮一下您和 Biogen 的擴張和商業努力。隨著季度的進展，我們該如何看待此類出貨量的成長加速？也許您可以幫助我們大致了解您付出的努力有多大。

And what type of impact do you expect from that would be helpful. And then a quick follow up on the inventory question. Can you just quantify if there was any inventory changes in the quarter that might have impacted the market revenue? Thank you.

您預計這會產生什麼類型的影響呢？然後快速跟進庫存問題。您能否量化本季是否存在可能影響市場收入的庫存變化？謝謝。

Thanks for the question. I'll talk about the first part and ask Chris if there's anything to comment on inventory. So look, as we said, the salesforce expansions were complete in the fourth quarter, -- in the first quarter. We are excited and encouraged to see over 20% growth in the first quarter in both revenues and demand.

謝謝你的提問。我將談論第一部分，並詢問克里斯對庫存是否有任何評論。所以，正如我們所說，銷售隊伍的擴張在第四季度，也就是第一季完成。我們很高興並鼓舞地看到第一季的收入和需求都增加了 20% 以上。

And I can't quantify it and we're not giving forward-looking forecasts, but we can say that we see quarter-on-quarter growth. And as we accounted previously, we're getting new writers every quarter and that is a strategic focus. And as you've heard Chris say many times, those new writers become repeat writers. So you think about that dynamic, as well as system-wide dynamic, continue to grow PPD.

我無法量化它，我們也沒有給出前瞻性的預測，但我們可以說我們看到了季度環比的成長。正如我們之前所說，我們每季都會引進新的作家，這是一個策略重點。正如克里斯多次說過的那樣，那些新作家會成為重複作家。因此，您可以考慮這種動態以及系統範圍的動態，繼續成長 PPD。

Again, we believe that ZURZUVAE is the key to unlock the blockbuster potential in PPD, and we believe we're on a trajectory to make that happen.

再次，我們相信 ZURZUVAE 是釋放 PPD 巨大潛力的關鍵，我們相信我們正走在實現這一目標的軌道上。

Chris, any inventory comments?

克里斯，有什麼庫存評論嗎？

Yes, I think in terms of inventory, I think I said it and I'll repeat the statement. I think there's fluctuation in terms of buying patterns associated with the wholesalers here. And as you see a therapy like ZURZUVAE that continues to grow quarter-over-quarter, your wholesalers are trying to project what inventory is going to look like.

是的，我認為就庫存而言，我想我已經說過了，我會重複一遍。我認為這裡的批發商的購買模式有波動。當您看到像 ZURZUVAE 這樣的療法持續逐季成長時，您的批發商正在試圖預測庫存將會是什麼樣子。

And when you add expansion into the mix, they're also trying to figure out how to really project forward what the inventory should look like. So there's going to be fluctuations in terms of inventory as they try to project forward what the, the uptake of ZURZUVAE is going to look as we go forward So I wouldn't point you to any one thing in the specific first quarter around inventory other than to go back and say the truest predictor of the success of the product is looking at the demand trend that we're on.

當你將擴張添加到組合中時，他們也在試圖弄清楚如何真正預測庫存應該是什麼樣子。因此，當他們試圖預測未來 ZURZUVAE 的吸收情況時，庫存方面會出現波動，因此，我不會向您指出第一季庫存方面的任何一件事，除了回過頭來說，產品成功的最真實預測因素是看我們所處的需求趨勢。

And as Barry noted, 22% quarter over quarter, more than 3,000 women with PPD receives their Zube.

正如 Barry 所指出的，與上一季相比，有 22% 的產後憂鬱症女性接受了 Zube 治療，超過 3,000 名。

Brian Abrahams, RBC Capital Markets.

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

Okay. Thanks so much for taking my question. What do you guys sense is the overall awareness of ZURZUVAE, both amongst [Ogus] and amongst the, expecting a new mother community. And I guess I'm also curious that what kind of metrics you can use to assess both that awareness as well as the degree to which screening for PPD may be increasing. Thanks.

好的。非常感謝您回答我的問題。你們覺得 Ogus 和準媽媽群體對 ZURZUVAE 的整體認知度如何？我也很好奇，您可以使用什麼樣的指標來評估這種認識以及 PPD 篩檢的增加程度。謝謝。

Thanks for it. Let me ask Chris to start and I can loop back with some additional color.

謝謝。讓我請克里斯開始，然後我可以用一些額外的顏色來循環。

Yes. So it's a great question, Brian. What I would say is, and we do tracking studies on a routine basis quarter-over-quarter. So we look at what physician awareness is of ZURZUVAE and what we've said is that there is approximately a 90% aided awareness for ZURZUVAE. Which, given where we are at the launch is remarkably high.

是的。所以，布萊恩，這是一個很好的問題。我想說的是，我們每季都會定期進行追蹤研究。因此，我們來看看醫生對 ZURZUVAE 的認識程度，我們說的是，對 ZURZUVAE 的輔助認識大約是 90%。考慮到我們目前發布的狀態，這個數字相當高。

So when you go out and you look at the physicians that are out there that are treating with PPD when you have the conversation with them around the medication, 90% with awareness knows ZURZUVAE and understand what it, what it's being used for. So again, I think that that's really remarkable at this stage.

因此，當您出去看看那些正在治療 PPD 的醫生，並與他們討論藥物時，90% 的人都知道 ZURZUVAE，並且了解它是什麼，它的用途。所以，我再次認為，在現階段這確實非常了不起。

We're going to continue to do everything that we've talked about around personal promotion through the salesforce as well as non-personal promotion to broaden reach, increase our frequency not only with OBGYNs. But also with psychiatrists and PCPs who see women with PPD to further expand that. Again, capitalizing on the understanding of the product and to broaden the impact that it has when a physician wants to choose ZURZUVAE for a woman with PPD.

我們將繼續透過銷售人員進行個人推廣以及非個人推廣，以擴大覆蓋範圍，增加我們的頻率，而不僅僅是婦產科醫生。但同時也與那些為患有 PPD 的女性看診的精神科醫生和 PCP 合作，進一步擴大了這一範圍。再次，利用對產品的了解並擴大其影響，當醫生想要為患有 PPD 的女性選擇 ZURZUVAE 時。

I would also say that we've seen a real uptick in terms of screening and diagnosis amongst those who've actually chosen to prescribe ZURZUVAE. So think about it like this. Once a physician has the experience with ZURZUVAE, he or she begins to change her prescribing practices, not only because of the interest in the medication, but an increased or a renewed interest in screening and diagnosis.

我還要說的是，在那些實際選擇開立 ZURZUVAE 處方的人群中，我們看到篩檢和診斷方面確實有所上升。所以請這樣想。一旦醫生有了使用 ZURZUVAE 的經驗，他或她就會開始改變她的處方習慣，這不僅是因為對藥物的興趣，而且是對篩檢和診斷的興趣增加或重新燃起。

So there's not just an opportunity here in effect for ZURZUVAE to be used, but it's to increase the overall size of the population that's viable for a medication like.

因此，這實際上不僅為 ZURZUVAE 的使用提供了一個機會，而且還能增加適合使用此類藥物的整體人口規模。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So wanted to ask you about your partner and specifically, is anything changed regarding their commitment to the product. And I guess to the extent that, things are status quo strategically, just looking at ZURZUVAE as primarily a women's health product and where the rest of Biogen's business is. Do you get the sense that their commitment to the product might wane just given the strategic fit or lack of strategic fit? Just wanted to get your thoughts there. Thank you.

謝謝。所以想問一下您的合作夥伴，特別是他們對產品的承諾有什麼改變嗎？我認為，從策略上來說，事情的現狀是這樣的，只是將 ZURZUVAE 視為主要的女性保健產品，也是 Biogen 其餘業務的所在地。您是否感覺到，由於策略契合度或缺乏策略契合度，他們對產品的忠誠度可能會減弱？只是想了解你的想法。謝謝。

Thanks, David, and welcome to the team. So what I can say is there's no change to the way we're working with our Biogen counterparts. And I'd say they like us are very excited by the impact, the profound impact we're having on PPD and the paradigm shift we're seeing in the market.

謝謝，大衛，歡迎加入團隊。因此我可以說的是，我們與 Biogen 同行的合作方式並沒有改變。我想說，他們和我們一樣，對我們對 PPD 產生的影響、深遠的影響以及我們在市場上看到的範式轉移感到非常興奮。

So, I mean, you have to ask them, but what we're seeing so far is highly encouraging in terms of a build to market opportunity.

所以，我的意思是，你必須問他們，但就市場機會而言，我們目前所看到的是非常令人鼓舞的。

Okay. Thank you.

好的。謝謝。

Douglas Tsao, H.C. Wainwright & Co. L.L.C.

曹德華，H.C.溫賴特有限責任公司

Hi, good afternoon. Can you hear me?

嗨，下午好。你聽得到我嗎？

Yes, Doug, we can hear you.

是的，道格，我們聽得到你的聲音。

So I think that you mentioned that once the driver writes a script was over there you could see greater activity for PPD in that office, are they? And I think you might have said, and I'm sorry if I misheard, but they might be writing other products as well. So I'm just curious sort of how you're seeing that mix and ultimately what it takes to shift them just so they can immediately go for that.

所以我認為您提到一旦司機寫了一個腳本，你就會看到那個辦公室的 PPD 活動更加活躍，對嗎？我想你可能已經說過了，如果我聽錯了我很抱歉，但他們可能也在開發其他產品。所以我只是好奇你是如何看待這種混合的，以及最終需要做什麼才能改變它們，以便它們可以立即實現這一目標。

Thanks. I'll take that. So just to clarify what we've said is once a healthcare provider in our case, mainly, OBGYNs writes ZURZUVAE, we're seeing a significant number of new PPD or PPD they're seeing in their practice. So see, you see a huge practice growth in terms of the women they're treating with PPD. We also said that more than 70% of the women prescribed ZURZUVAE are receiving it as their first new treatment for PPD.

謝謝。我會接受的。因此，為了澄清我們所說的內容，在我們的案例中，醫療保健提供者，主要是婦產科醫生寫道，我們在實踐中看到了大量新的 PPD 或 PPD。所以，你看，他們治療的女性產後憂鬱症的病例數有了巨大的增長。我們也表示，超過 70% 接受 ZURZUVAE 治療的女性都是將其作為 PPD 的首個新療法。

So that trend is a very strong trend. I said this earlier, there aren't really obstacles getting in the way of frontline use. You might have a mom already on an antidepressant where ZURZUVAE is added. So that wouldn't be part of the 70%, but we're not seeing a reluctance to use ZURZUVAE first.

所以這種趨勢非常強勁。我之前就說過，其實沒有什麼障礙阻礙前線的使用。您的媽媽可能已經在服用添加了 ZURZUVAE 的抗憂鬱藥物。因此這不屬於 70% 的一部分，但我們並沒有看到人們不願意先使用 ZURZUVAE。

Okay. And that that's really helpful. And then I guess, I'm just curious if you any, and obviously you did grow quarter-on-quarter. I'm just curious if you saw any regional impact, obviously across the industry we typically be, resets and so forth. And so, I'm just curious if, as we think about the future quarters of sort of catch up in terms of the drug.

好的。這確實很有幫助。然後我想，我只是好奇你是否有，而且顯然你確實實現了季度環比增長。我只是好奇您是否看到了任何區域影響，顯然整個行業通常都會受到影響，重置等等。所以，我只是好奇，當我們考慮未來幾季在藥物方面是否會迎頭趕上。

So again, we, completed the salesforce expansion in the first quarter. There's some disruption when you do that, we still had strong quarter-to-quarter growth. And it's too early to know whether there's any kind of seasonality associated with ZURZUVAE and PPD. We don't have the classic first quarter Medicare issues that some drugs have. This is commercial Medicaid, so we wouldn't see that.

因此，我們在第一季完成了銷售團隊的擴張。當你這樣做時，雖然會出現一些混亂，但我們仍然實現了強勁的季度環比增長。現在判斷 ZURZUVAE 和 PPD 是否有任何季節性還為時過早。我們並沒有遇到某些藥物所面臨的典型的第一季醫療保險問題。這是商業醫療補助，所以我們不會看到這種情況。

Great. Thank you very much.

偉大的。非常感謝。

Ur Ear. Mizuho Securities USA, LLC.

你的耳朵。瑞穗證券美國股份有限公司

Hey guys, thanks for taking a question. Just curious, could you speak a bit about Gross and that, whether you've seen it improve from our, from the fourth quarter, or does it, -- or did in this quarter did experience a typical, gross and net depression that other products, in the space experience. Thanks.

嘿夥計們，謝謝你們回答問題。只是好奇，您能否談談 Gross 的情況？您是否看到它從第四季度開始有所改善，或者本季度是否經歷了該領域其他產品所經歷的典型的總收入和淨收入下滑。謝謝。

Chris, you want to take that?

克里斯，你想接受這個嗎？

Yes. We haven't communicated exactly what the gross to net is, in terms of the percentage. What we've said though is that when you think about the gross net for ZURZUVAE, which is the first oral therapy approved for the treatment of women with PPD, that it doesn't require the same type of gross tone that you might see with other antidepressants used.

是的。我們還沒有明確說明毛利與淨利的百分比是多少。然而，我們要說的是，當你考慮到 ZURZUVAE 的整體淨效應時，你會發現它並不需要像使用其他抗憂鬱藥物時那樣產生同樣類型的總體音調，ZURZUVAE 是第一種獲準用於治療女性 PPD 的口服療法。

A more broadly in this category because I think payers recognize the novel or the uniqueness of this medication, which is really important. So we haven't communicated the number. It's not that substantial gross tone that we've talked about and I think Barry, as you said it, given that there isn't fluctuations associated with Medicare and things like that you wouldn't expect to see the ups and downs associated with Gross-tonne in a category like this with the medication likes ZURZUVAE.

這個類別更廣泛，因為我認為付款人認識到這種藥物的新穎性或獨特性，這非常重要。所以我們還沒有告知這個數字。這並不是我們討論過的那種實質性的總基調，我認為，正如巴里所說，考慮到與醫療保險和類似事物相關的波動，你不會期望看到像 ZURZUVAE 這樣的藥物類別中的總噸位出現起伏。

Thanks, Chris. Thanks for the question.

謝謝，克里斯。謝謝你的提問。

Joel Beatty, Robert W. Baird & Co.

喬爾比蒂、羅伯特W貝爾德公司

Thanks. In the survey we published earlier this month, we received comments from quite a few docs that said they liked the profile of ZURZUVAE and wanted to prescribe it more. But then they said that getting par coverage is often challenging, that this had been a barrier to their use. I'm so curious, how does that fit with what you're hearing from OBGYNs regarding challenging payer coverage?

謝謝。在我們本月稍早發布的調查中，我們收到了不少醫生的評論，他們表示喜歡 ZURZUVAE 的特性並希望能開這種藥。但隨後他們表示，獲得標準保險通常很困難，這成為了他們使用的障礙。我很好奇，這與您從婦產科醫生那裡聽到的有關挑戰付款人保險的說法有什麼關係？

Yes, Joel. I think, we hear a lot about these surveys, and I would challenge you to find out those you're surveying whether they're actually using the drug or not or whether they're making assumptions. We see a lot of surveys come back with historical biases, which are not true. You heard us, we've got over 95% coverage.

是的，喬爾。我想，我們已經聽到很多關於這些調查的消息，我想挑戰你去了解那些你正在調查的人是否真的在使用這種藥物，或者他們是否在做出假設。我們發現許多調查結果都帶有歷史偏見，但事實並非如此。您聽到了，我們的覆蓋率已超過 95%。

So the coverage is very, very strong. Now, sometimes we hear about a challenge with prior off or specialty pharma, but the majority of moms are getting a vast majority of moms are getting ZURZUVAE in less than a week from prescription and many receive ZURZUVAE in two to three days. So we are not hearing issues with coverage at all.

因此覆蓋範圍非常非常廣。現在，有時我們會聽到先前的處方藥或專科藥物存在挑戰，但大多數媽媽在開處方後不到一周就能收到 ZURZUVAE，許多媽媽在兩到三天內就能收到 ZURZUVAE。所以我們根本沒有聽到有關覆蓋範圍的問題。

I would add, Barry, 70% of women prescribed ZURZUVAE are receiving it as their first new treatment for PPD, which again is another proof point for the kind of coverage that we have and the ability of a woman with PPD to get it and to get it without owners prior authorizations step in.

我想補充一點，巴里，70% 接受 ZURZUVAE 處方的女性都是將其作為她們首次接受的產後抑鬱症新療法，這再次證明了我們的保險範圍以及產後抑鬱症女性獲得該藥物的能力，並且無需獲得患者事先授權即可獲得該藥物。

This this launch profile is very different than quote unquote classic branded launches and unfortunately, what we see is we see many healthcare providers answering questions with the bias historical bias rather than a current fact base.

這次的發表會與所謂的傳統品牌發布會非常不同，不幸的是，我們看到許多醫療保健提供者在回答問題時帶有歷史偏見，而不是基於當前的事實。

Thank you.

謝謝。

Laura Chico, Wedbush Securities.

勞拉‧奇科（Laura Chico），韋德布希證券公司。

Hi, good afternoon. Thanks very much for putting me in here. I guess, one question I just wanted to clarify, I know there were about 3,000 shipments in the quarter that occurred. Have you quantified the number of HCPs you have that are actively prescribing? And I'm just trying to understand what would be a reasonable or aspirational goal in terms of the number of prescribers. Thanks.

嗨，下午好。非常感謝您讓我來到這裡。我想，我只是想澄清一個問題，我知道本季大約有 3,000 批貨物。您是否量化了積極開處方的 HCP 數量？我只是想了解就處方數量而言，合理或理想的目標是什麼。謝謝。

Thanks, Laura for the equipment. The question. Let me ask Chris to comment.

謝謝勞拉提供的設備。問題。讓我請克里斯發表評論。

Yes. So Laura, we've looked at the number. We have a sense for the size of the population here, in terms of OBGYNs and psychiatrists and PCPs, but we haven't communicated the number at this time. What we've talked about is the number of shipments that go out. We've talked about the percentage of prescriptions coming from OBGYNs and other physicians. So not from us yet on the exact number of physicians.

是的。蘿拉，我們已經看過這個數字了。就婦產科醫生、精神科醫生和初級保健醫生而言，我們了解這裡的人口規模，但目前我們還沒有公佈具體數字。我們討論的是發貨的數量。我們已經討論了來自婦產科醫生和其他醫生的處方所佔的百分比。因此我們目前還不清楚醫生的具體人數。

Exact. What I would add, Laura, and you, it's an astute question is again, we continue to see new writers coming on every quarter. We don't see that stopping. Once we bring new writers on, they become repeat writers. Obviously, the new writers from last quarter repeat writers, and more and more offices come on where they're using more than 70% front line.

精確的。勞拉和你，我想補充的是，這是一個敏銳的問題，我們每季都會看到新的作家出現。我們認為這種情況不會停止。一旦我們引進新作家，他們就會成為重複作家。顯然，上個季度的新作家重複了作家，並且越來越多的辦公室加入，他們使用了超過 70％ 的一線作家。

And continuing to repeat. So the reason we're confident in our quarter-to-quarter growth is that the dynamics are placed to continue to make that happen.

並不斷重複。因此，我們之所以對季度環比成長充滿信心，是因為我們有足夠的動力繼續實現這一目標。

Okay, that's helpful, Barry. Maybe I'll just to one. I'll talk kind of related, but I don't know if you'll be able to answer this in terms of the average script per provider, how are you, would you be able to quantify kind of the changes you're seeing there? I think your qualitative commentary suggest it's increasing but wondering if you can add any metrics there. Thank you.

好的，這很有幫助，巴里。也許我只會去一個。我會談論一些相關的事情，但我不知道您是否能夠根據每個提供者的平均腳本來回答這個問題，您好嗎，您能否量化您在那裡看到的變化？我認為您的定性評論表明它正在增加，但想知道您是否可以在那裡添加任何指標。謝謝。

I can't, I can't quantify it. We're really not providing that. We are saying that once someone writes, we see a significant number of new patients they're treating the practice. And again, if the ZURZUVAE is used more than 70% front line, we're getting most of that use. There are dynamics where someone might be an antidepressant or previous antidepressant, but that 70% continues to grow. And, once we raise awareness in an office, they don't look back. They want to treat postpartum depression.

我不能，我無法量化它。我們確實沒有提供這個。我們說的是，一旦有人寫信，我們就會看到他們正在治療大量新患者。再說一次，如果 ZURZUVAE 在前線的使用率超過 70%，那麼我們將獲得大部分的使用率。存在這樣的動態，即某人可能正在服用抗憂鬱藥物或曾經服用過抗憂鬱藥，但 70% 的比例仍在繼續增長。而且，一旦我們提高了辦公室的意識，他們就不會回頭。他們想要治療產後憂鬱症。

Thanks very much.

非常感謝。

Thanks Laura. I appreciate it.

謝謝勞拉。我很感激。

[Marc Goodman], Leerink Partners.

[Marc Goodman]，Leerink Partners。

Hi, good afternoon. This is [Basman] from Marc. Can you please tell us what is the current penetration in the OBGYNs, and what is your target? And we also have a second question on the pipeline, regarding the 319 and the DEEs. Are you basing the decision to advance the development in the DEEs based on the safety profile? And if so, what is the threshold of Sunderland's rates to make a go- or no-go decision for the development? That's it for us. Thank you.

嗨，下午好。我是馬克的[巴斯曼]。您能否告訴我們目前婦產科的滲透率是多少，以及您的目標是什麼？我們還有關於管道的第二個問題，涉及 319 和 DEE。您是否根據安全性來決定是否要推進 DEE 的開發？如果是這樣，桑德蘭的稅率門檻是多少，才能決定是否要進行開發？對我們來說就是這樣。謝謝。

So let me start with the second one. I think if you're talking about DEEs, we're talking about stage three to four, and there's a number of factors we're looking into. It's not about it, it's about whether doses that are suitable for chronic administration will work in the DE population. It's also about what the regulatory pathway looks like in our portfolio.

那麼讓我從第二個開始。我認為，如果您談論的是 DEE，我們談論的是第三到第四階段，我們正在研究許多因素。問題不在於此，而是適合長期服用的劑量是否對 DE 族群有效。這也與我們的投資組合中的監管途徑有關。

So once we have clarity around do regulatory pathway portfolio will guide mid this year, the path forward, if any, with three to four. I'm not sure we can say much more about your first question, so I think we've already talked about that.

因此，一旦我們明確了監管途徑組合，我們將在今年年中指導前進的道路（如果有的話），有三到四個。我不確定我們是否可以就您的第一個問題再多說一些，所以我想我們已經討論過這個問題了。

Got it. Thank you.

知道了。謝謝。

Sumant Kulkarni, Canaccord Genuity.

Sumant Kulkarni，Canaccord Genuity。

Good afternoon. Thanks for taking my question. It's nice to see the growth on the ZURZUVAE, but what specifically needs to happen to get a more meaningful inflection on the product? Ao we could see sales far outstrip the SG&A dollars that are spent currently, and how would you put that in context relative to your current cash runway or versus the timelines on any meaningful pipeline catalyst that might help extend that runway?

午安.感謝您回答我的問題。很高興看到 ZURZUVAE 的成長，但具體需要做些什麼才能讓產品有更有意義的轉變？因此，我們可以看到銷售額遠遠超過目前花費的銷售、一般和行政費用，您如何將其與您當前的現金流或可能有助於延長現金流的任何有意義的管道催化劑的時間表進行比較？

Sumant, thanks for the multifactorial question there. So look, we're excited the fact by the fact that we had greater than 20% growth in the first quarter from fourth quarter in both demand and revenue. As we've said, we continue to see quarter to quarter growth now that the expanded forces in there and we've got an aligned commercialization plan. We don't see that growth slowing.

Sumant，謝謝你提出這個多因素的問題。所以，我們很興奮，因為第一季的需求和收入都比第四季成長了 20% 以上。正如我們所說，由於內部力量不斷擴大，並且我們制定了一致的商業化計劃，我們繼續看到季度環比增長。我們認為成長不會放緩。

We've also said that ZURZUVAE is a brand. Will be cash flow positive exiting 2026. We're pretty confident in that as we see opportunities to expand or spend more to continue to grow or ZURZUVAE, we'll take advantage of those opportunities. In terms of product pipeline progression overall profile of the company, we've guided that we've got cash runway into 2027.

我們也說過，ZURZUVAE 是一個品牌。2026 年後現金流將為正值。我們非常有信心，當我們看到擴張或投入更多資金以繼續成長或 ZURZUVAE 的機會時，我們會利用這些機會。就公司產品線進度整體而言，我們預計到 2027 年我們的現金流量將會充足。

And what goes on further will depend upon data and our decisions to move other drugs forward.

而進一步的發展將取決於數據和我們推動其他藥物發展的決定。

Thank you.

謝謝。

Ronal Dias, Truist Securities.

Ronal Dias，Truist Securities。

Good afternoon. This is awesome. Ronal on for Joon. Congrats on the quarter and thanks for taking the questions. Just a question on 324. I mean, what remaining work are you looking to do on 324 to develop for DEE? And then, in terms of ZURZUVAE, what's the persistence of prescribers? Do you see any prescribers that start the drug and then stop prescribing? Thank you.

午安.這太棒了。羅納 (Ronal) 替換瓊 (Joon)。恭喜本季取得佳績，感謝您回答問題。這只是關於 324 的一個問題。我的意思是，您希望在 324 上進行哪些剩餘工作來為 DEE 進行開發？那麼，就 ZURZUVAE 而言，開處方者的堅持程度如何？您是否看過有開藥者開始開這種藥然後又停止開藥？謝謝。

Yes, let me take the second one, I guess. In terms of ZURZUVAE, as we've said, once a healthcare provider writes ZURZUVAE, they become a repeat writer. We're seeing that consistently can't really comment on those that have written and stopped. We're not seeing that dynamic in the marketplace. It's quite the opposite, in terms of three to four, as we said earlier on the call, we're looking at dose appropriate for chronic administration DEEs, regulatory pathway and our overall portfolio.

是的，我想選第二個。就 ZURZUVAE 而言，正如我們所說，一旦醫療保健提供者簽署了 ZURZUVAE，他們就會成為重複承保人。我們看到，我們始終無法真正評論那些已經寫完但又停止寫的人。我們在市場上沒有看到這種動態。事實恰恰相反，就三到四種而言，正如我們早些時候在電話會議上所說的那樣，我們正在研究適合慢性給藥 DEE 的劑量、監管途徑和我們的整體產品組合。

And once we have clarity on all of those, which will have mid-year, we'll provide some guidance on paths forward if any. Just another point is, we're not spending developmental dollars on stage 3 to 4. It's really people working on answering questions at about. Thank you.

一旦我們在年中明確了所有這些問題，我們將提供一些關於未來發展的指導（如果有的話）。還有一點是，我們不會在第 3 至 4 階段花費開發資金。這其實是人們在努力回答問題。謝謝。

Thank you.

謝謝。

This will conclude the Q&A portion of today's call. With that, I will turn it back over to Mr. Green for closing remarks.

今天電話會議的問答部分就到此結束。接下來，我將把發言權交還給格林先生，請他作最後發言。

Thanks, Rachel, and thanks again to everyone for joining us this afternoon to review our results from the first quarter of 2025. As we look ahead to the ongoing commercialization of ZURZUVAE and advancements in our focus pipeline, I'm confident that we're making important progress on our mission to deliver life-changing brain health medicines. So every person can thrive. Thanks again, everyone, and have a great evening. Bye.

謝謝 Rachel，再次感謝大家今天下午加入我們，回顧我們 2025 年第一季的業績。展望 ZURZUVAE 的持續商業化以及我們重點產品線的進步，我相信我們在提供改變生活的大腦健康藥物的使命上正在取得重要進展。因此每個人都可以茁壯成長。再次感謝大家，祝大家有個愉快的夜晚。再見。

This does conclude today's call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。