SAGE Therapeutics Inc (SAGE) 2024 Q3 法說會逐字稿

Good afternoon. Welcome to Sage Therapeutics third-quarter 2024 financial results conference call.

午安.歡迎參加 Sage Therapeutics 2024 年第三季財務業績電話會議。

Currently all participants are in a listen-only mode. This call is being webcast live on the investors and media section of Sage's website at sagerx.com. This call is a 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.

目前所有參與者都處於僅監聽模式。此次電話會議正在 Sage 網站 sagerx.com 的投資者和媒體部分進行網路直播。本次通話屬於 Sage Therapeutics 的財產，未經 Sage Therapeutics 明確書面同意，嚴禁錄製、複製或傳播本次通話。請注意，此通話正在錄音。

I would now like to introduce Katie Plante, Manager of Investor Relations at Sage.

現在我想介紹一下 Sage 投資者關係經理凱蒂普蘭特 (Katie Plante)。

Good afternoon and thank you for joining Sage Therapeutics third-quarter 2024 financial results conference call.

下午好，感謝您參加 Sage Therapeutics 2024 年第三季財務業績電話會議。

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.

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，您可以在其中找到與今天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. 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 third-quarter of 2024. Our Chief Business Officer, Chris Benecchi, will provide an update on the ongoing commercialization of ZURZUVAE.

我想指出的是，我們將根據我們目前的期望和信念做出前瞻性聲明。這些陳述存在一定的風險和不確定性，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 SEC 文件中討論的風險因素，以了解更多詳細資訊。我們將首先由我們的執行長 Barry Greene 準備好講話，他將概述我們在 2024 年第三季度取得的進展。我們的首席商務官 Chris Benecchi 將提供 ZURZUVAE 正在進行的商業化的最新資訊。

We will then be joined by Laura Gault, our Chief Medical Officer, who will review development activities across our program. We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results from the third quarter of 2024. Mike Quirk, our Chief Scientific Officer, will be available for questions during the Q&A portion of the call.

然後，我們的首席醫療官 Laura Gault 將加入我們，她將審查整個專案的開發活動。然後，我們的財務長 Kimi Iguchi 將與我們一起審查我們 2024 年第三季的財務業績。我們的首席科學官 Mike Quirk 將在電話問答部分回答問題。

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

現在，我將把電話轉給巴里。

Thanks, Katie, and thank you, everyone, for joining us this afternoon.

謝謝凱蒂，也謝謝大家今天下午加入我們。

Discovering new medicines and bringing them to market, especially in brain health is a formidable challenge. But when successful has potential for major advances in human health. The impact of our work in postpartum depression is an important example of this. However, other areas of drug development, including the most devastating brain health conditions remain the next frontier.

發現新藥並將其推向市場，尤其是在大腦健康領域，是一項艱鉅的挑戰。但一旦成功，就有可能為人類健康帶來重大進步。我們的工作對產後憂鬱症的影響就是一個重要的例子。然而，藥物開發的其他領域，包括最具破壞性的大腦健康狀況，仍然是下一個前沿領域。

Recent pipeline setbacks require us to further focus our business priorities. We announced earlier this month that we are implementing a reorganization of our business operations intended to strengthen our balance sheet and focus investment to support the ongoing launch of ZURZUVAE for the treatment of women with PPD, our upcoming readout in Huntington's disease and exploring opportunities across our early-stage pipeline.

最近的管道挫折要求我們進一步關注我們的業務重點。我們本月稍早宣布，我們正在對我們的業務運營進行重組，旨在加強我們的資產負債表，並重點投資以支持正在推出的用於治療產後抑鬱症女性的ZURZUVAE，我們即將發布的亨廷頓生病報告，並探索我們整個領域的機會。

This decision was necessary. We believe that this restructuring will right-size Sage for future success. I'm grateful to all our employees, including those departing for their impact on our business and dedication to making a difference for patients.

這個決定是必要的。我們相信，此次重組將調整 Sage 的規模，以實現未來的成功。我感謝我們所有的員工，包括那些離職的員工，他們對我們的業務產生了影響，並致力於為患者帶來改變。

As you've seen our recent press release, we're also making the strategic decision to stop making ZULRESSO commercially available after December 31, 2024. As we've noted, we've made progress in supporting more women with PPD since the launch of ZURZUVAE. And we see this important treatment accelerating change in the PPD treatment paradigm. With the increased demand for ZURZUVAE and the treatment of women with PPD, we're also seeing an expected decrease in demand for ZULRESSO. We believe health care providers who prescribe ZULRESSO will continue to transition to ZURZUVAE and that women with PPD will be well supported by ZURZUVAE. It's a logical business decision to discontinue availability and focus our resources on ZURZUVAE, so we can help even more women with PPD.

正如您所看到的，我們也做出了策略性決定，即在 2024 年 12 月 31 日之後停止 ZULRESSO 的商業化銷售。正如我們所指出的，自 ZURZUVAE 推出以來，我們在支持更多患有產後憂鬱症的女性方面取得了進展。我們看到這項重要的治療加速了 PPD 治療模式的改變。隨著對 ZURZUVAE 的需求增加以及對患有產後憂鬱症 (PPD) 的女性的治療，我們預計對 ZULRESSO 的需求也會減少。我們相信，開出 ZULRESSO 處方的醫療保健提供者將繼續轉向 ZURZUVAE，患有 PPD 的女性將得到 ZURZUVAE 的大力支持。停止供應並將我們的資源集中在 ZURZUVAE 上是一個合乎邏輯的商業決策，這樣我們就可以幫助更多患有產後憂鬱症的女性。

Now, as we are focused on PPD, Sage and Biogen will also not pursue further development of zuranolone as a treatment for major depressive disorder in the US. Based on the significant new investment and time we expect would be needed to conduct the additional studies and we're prioritizing our resources and supporting the PPD patient community.

現在，由於我們專注於 PPD，Sage 和 Biogen 也不會在美國進一步開發 zuranolone 作為治療重度憂鬱症的藥物。基於我們預計進行額外研究所需的大量新投資和時間，我們正在優先考慮我們的資源並支持 PPD 患者社群。

We're grateful to all the patients, providers, and advocates who have supported our clinical trials and efforts in MDD. We believe these decisions will provide us with the agility, cash runway, and focus to advance our business. We continue to build a foundation for the future that is supported by the momentum we're seeing with ZURZUVAE. Last year, we set a goal to establish ZURZUVAE as a first-line therapy and standard of care for women with PPD. We're making progress as demonstrated in our third consecutive quarter of solid growth.

我們感謝所有支持我們在 MDD 臨床試驗和努力的患者、提供者和倡導者。我們相信這些決策將為我們提供敏捷性、現金跑道和重點來推進我們的業務。我們將繼續為未來奠定基礎，並得到 ZURZUVAE 的發展動能的支持。去年，我們設定了目標，將 ZURZUVAE 確立為患有 PPD 的女性的一線療法和護理標準。我們正在取得進展，連續第三個季度的穩健成長就證明了這一點。

ZURZUVAE has a critical role in advancing PPD care by helping to support a dialogue between health care providers and women with PPD, a condition that has often been stigmatized and undertreated. As a result, more women have the potential to be treated for PPD and more OB/GYNs should begin to screen, diagnose, and treat this disorder. We believe the shift in practice patterns is starting among OB/GYNs who are now integrating maternal mental health with obstetric care and initiating medical treatment for PPD.

ZURZUVAE 透過幫助支持衛生保健提供者和患有產後憂鬱症的婦女之間的對話，在推進產後憂鬱症護理方面發揮關鍵作用，產後憂鬱症經常受到污名化和治療不足。因此，更多的女性有可能接受產後憂鬱症治療，更多的婦產科醫生應該開始篩檢、診斷和治療這種疾病。我們相信，實踐模式的轉變正在婦產科醫生中開始，他們現在正在將孕產婦心理健康與產科護理相結合，並開始針對產後憂鬱症的醫療。

In fact, once an OB/GYN has written ZURZUVAE, on average, we see an encouraging increase in the number of women with PPD they treat based on written prescriptions for all medications. All those health care prescribers prescribing ZURZUVAE, the majority are using ZURZUVAE as a first-line PPD treatment.

事實上，一旦婦產科醫生寫下了 ZURZUVAE，平均而言，我們會看到他們根據所有藥物的書面處方治療的產後憂鬱症女性人數出現了令人鼓舞的增長。所有開立 ZURZUVAE 處方的醫療保健處方者中，大多數都使用 ZURZUVAE 作為第一線 PPD 治療。

We're seeing broad and favorable coverage for ZURZUVAE in PPD and progress across the ecosystem continues to energize our efforts. This launch women with PPD are going online and sharing their treatment success stories, medical associations are publishing screen guidelines, payers are recognizing the benefit of innovation, and the media continue to discuss PPD as an urgent and treatable medical condition. While progress in overall screening rates for PDD is encouraging, it should be the first step in the delivery process to ensure women who are diagnosed with PPD understand their options for care. Chris will provide more specific breakdown of our commercial performance in Q3. Looking ahead, we plan to continue to scale with success and believe that our strategic investments including our recent sales force expansion will accelerate the demand and market growth for ZURZUVAE in PPD.

我們看到 ZURZUVAE 在 PPD 中得到了廣泛而有利的覆蓋，整個生態系統的進展繼續激勵我們的努力。此次發布，患有產後憂鬱症的女性正在網路上分享她們的治療成功故事，醫學協會正在發布螢幕指南，付款人正在認識到創新的好處，媒體繼續將產後憂鬱症作為一種緊急且可治療的疾病進行討論。雖然 PDD 整體篩檢率的進展令人鼓舞，但這應該是分娩過程中的第一步，以確保被診斷為 PPD 的女性了解她們的護理選擇。克里斯將提供我們第三季商業業績的更具體細分。展望未來，我們計劃繼續成功擴大規模，並相信我們的策略投資（包括最近的銷售團隊擴張）將加速 PPD 領域 ZURZUVAE 的需求和市場成長。

Now turning to the pipeline, earlier this month, we reported that the Phase 2 LIGHTWAVE Study in Alzheimer's disease did not meet the primary endpoint. We're disappointed for the millions of patients suffering with Alzheimer's disease. We look forward to reporting top-line data from the Phase 2 DIMENSION Study of dalzanemdor people with cognitive impairment associated with Huntington's disease expected later this year.

現在轉向管道，本月早些時候，我們報告了阿茲海默症的 2 期 LIGHTWAVE 研究未達到主要終點。我們對數百萬患有阿茲海默症的患者感到失望。我們期待在今年稍後報告針對患有亨廷頓氏症相關認知障礙的達札內多患者的 2 期 DIMENSION 研究的主要數據。

Finally, we announced in September that Biogen has decided to terminate our collaboration and license agreement for the SAGE-324 program. The determination of this agreement Sage will have full ownership of SAGE-324 and we plan to continue to evaluate potential indications if any for the program. We anticipate that any future investment in SAGE-324 will be based on a broader portfolio review and pipeline prioritization. Our commitment to advance brain health medicines endures through our successes and setbacks. Patient impact, long-term growth, and value creation remain our guiding principles.

最後，我們在 9 月宣布 Biogen 決定終止我們在 SAGE-324 專案上的合作和授權協議。該協議的確定 Sage 將擁有 SAGE-324 的全部所有權，我們計劃繼續評估該項目的潛在適應症（如果有）。我們預計未來對 SAGE-324 的任何投資都將基於更廣泛的投資組合審查和管道優先順序。我們對推動腦健康藥物的承諾在我們的成功和挫折中始終如一。病患影響、長期成長和價值創造仍然是我們的指導原則。

With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of ZURZUVAE.

接下來，我會將電話轉給 Chris，以提供有關 ZURZUVAE 正在進行的商業化的更多背景資訊。

Chris?

克里斯？

Thanks, Barry.

謝謝，巴里。

We have achieved notable progress in our launch of ZURZUVAE over the third quarter. We are making notable strides in our goal to establish ZURZUVAE as the first-line therapy and standard of care for women with PPD.

第三季度，我們在推出 ZURZUVAE 方面取得了顯著進展。我們在將 ZURZUVAE 確立為產後憂鬱症女性第一線治療和護理標準的目標方面取得了顯著進展。

ZURZUVAE generated $22.1 million in total revenue in the third quarter of 2024 of which Sage recognized $11 million in collaboration revenue. This represents its 49% growth in revenue over the second quarter. We also observed increased demand is measured by shipments in the third quarter with approximately 2,000 prescriptions filled and delivered to women with PPD. This represents an approximately 40% growth compared to the second quarter.

ZURZUVAE 在 2024 年第三季產生了 2,210 萬美元的總收入，其中 Sage 確認了 1,100 萬美元的協作收入。這意味著其第二季度收入成長了 49%。我們還觀察到，需求的成長是透過第三季的出貨量來衡量的，大約有 2,000 份處方藥配發並交付給患有 PPD 的女性。這意味著與第二季度相比增長了約 40%。

Inventory levels have normalized since the initial build at launch. Additionally, we saw a reduction in the percentage of free goods as commercial and Medicaid policies covering ZURZUVAE have been implemented.

自最初發布以來，庫存水準已經正常化。此外，隨著涵蓋 ZURZUVAE 的商業和醫療補助政策的實施，我們發現免費商品的比例有所下降。

Prescriber trends also signal encouraging growth of ZURZUVAE as a treatment for women with PPD. We're building from a strong foundation with data that suggests 90% aided brand awareness among OB/GYNs and psychiatrists. Prescribers and repeat writers continue to increase quarter over quarter with most new prescriptions initiating after an interaction with the sales representative. These data and trends reinforce our view that this is a promotionally-sensitive market with potential to further scale as we've recently done with our field sales force expansion. ZURZUVAE is being prescribed across a breadth of HCPs who treat PPD. Importantly, OB/GYNs continue to lead the way, accounting for 70% of all prescribers.

處方者的趨勢也顯示 ZURZUVAE 作為治療產後憂鬱症女性藥物的成長令人鼓舞。我們正在建立一個堅實的基礎，數據顯示 90% 的婦產科醫生和精神科醫生提高了品牌知名度。處方者和重複處方者數量繼續逐季增加，大多數新處方都是在與銷售代表互動後開始的。這些數據和趨勢強化了我們的觀點，即這是一個對促銷敏感的市場，有潛力進一步擴大規模，就像我們最近擴大現場銷售團隊所做的那樣。ZURZUVAE 正在為許多治療 PPD 的 HCP 開出處方。重要的是，婦產科醫生繼續處於領先地位，佔所有處方者的 70%。

A majority of the OB/GYNs who first wrote a script prior to July 2024 have written multiple prescriptions. This is noteworthy as OB/GYNs are at the forefront of peripartum care, seeing these women at the most critical time to screen, diagnose, and treat PPD.

大多數在 2024 年 7 月之前首次編寫腳本的婦產科醫生已經編寫了多個處方。值得注意的是，婦產科醫師處於圍產期護理的最前沿，在最關鍵的時刻為這些女性提供篩檢、診斷和治療產後憂鬱症的服務。

At the same time, we continue to recognize broad and equitable coverage as a critical element of our efforts to ensure women with PPD get access to this important treatment. As of today, more than 90% of commercial and Medicaid lives are covered with a vast majority of policies enabling first-line access to ZURZUVAE for women with PPD without burdensome prior authorizations. I'm pleased to report that all three national PBMs have now developed favorable coverage policies for ZURZUVAE in the treatment of PPD.

同時，我們繼續認識到廣泛和公平的覆蓋範圍是我們努力確保患有產後憂鬱症的女性獲得這項重要治療的關鍵要素。截至目前，絕大多數保單涵蓋了超過 90% 的商業和醫療補助生活，使患有 PPD 的女性無需繁瑣的事先授權即可獲得 ZURZUVAE 的一線服務。我很高興地報告，所有三個國家 PBM 現已製定了針對 ZURZUVAE 治療 PPD 的有利承保政策。

The progress we've made this quarter speaks to the need and strong value proposition for ZURZUVAE in the treatment of women with PPD. Very articulated our drill strategy when we launched ZURZUVAE at the end of 2023 to think big about the opportunity in PPD, start with a focused approach, and scale strategically with success.

我們本季的進展證明了 ZURZUVAE 在治療產後憂鬱症女性方面的需求和強大的價值主張。當我們在 2023 年底推出 ZURZUVAE 時，非常清楚地闡明了我們的鑽探策略，以大局考慮 PPD 的機會​​，從有針對性的方法開始，並在策略上取得成功。

Our plan to accelerate growth of ZURZUVAE in PPD is centered around three key areas. First, we plan to continue to expand the HCP prescriber base through field force expansion and increasing peer-to-peer engagement, education, and awareness programs in Q4. Sage's expanded sales force is in the field as of the start of Q4. We plan to support repeat writing in PPD by prioritizing a positive clinical and brand experience, including through an efficient prescription fulfillment process.

我們加速 ZURZUVAE 在 PPD 領域發展的計畫主要圍繞著三個關鍵領域。首先，我們計劃在第四季度透過擴大現場隊伍和增加同儕參與、教育和意識計劃，繼續擴大 HCP 處方者基礎。Sage 擴大的銷售團隊已於第四季初投入使用。我們計劃透過優先考慮積極的臨床和品牌體驗（包括透過高效的處方履行流程）來支持 PPD 中的重複寫作。

Our goal is for HCPs and women with PPD prescribe ZURZUVAE to feel supported throughout the process. And finally, we plan to leverage targeted media, digital channels, and social media influencers to empower more women to discuss their PPD symptoms with their HCPs and ask if ZURZUVAE is an appropriate treatment option. We are inspired by the ongoing efforts of the PPD community to create real and lasting change in the health care system which fuels our shared commitment to support women with PPD.

我們的目標是讓 HCP 和患有 PPD 的女性在服用 ZURZUVAE 的過程中感受到支持。最後，我們計劃利用有針對性的媒體、數位管道和社群媒體影響者，讓更多女性能夠與 HCP 討論她們的 PPD 症狀，並詢問 ZURZUVAE 是否是合適的治療選擇。PPD 社區為醫療保健系統創造真正和持久的變革所做的持續努力激勵了我們，這推動了我們支持患有 PPD 的女性的共同承諾。

I look forward to sharing updates on our commercialization efforts in the coming quarters.

我期待在未來幾季分享我們商業化工作的最新進展。

With that, I will turn it over to Laura to highlight our pipeline updates.

有了這個，我將把它交給勞拉來強調我們的管道更新。

Laura?

勞拉？

Thanks, Chris, and good afternoon, everyone.

謝謝克里斯，大家下午好。

We continue to believe that ZURZUVAE is contributing to the growing momentum in the health care community to recognize and treat PPD. I'm encouraged by the progress we are making and the potential to help even more women with PPD.

我們仍然相信，ZURZUVAE 正在為醫療保健界認識和治療 PPD 的不斷增長的勢頭做出貢獻。我對我們所取得的進展以及幫助更多患有產後憂鬱症的女性的潛力感到鼓舞。

With regard to the clinical stage pipeline, in early October, we announced the results from the Phase [3] LIGHTWAVE Study in Alzheimer's disease. Unfortunately, there was not a statistically significant difference from baseline to day 84 in participants treated with dalzanemdor versus placebo as assessed by the WAIS-IV coding test, the primary endpoint.

關於臨床階段管道，10月初，我們發表了阿茲海默症第[3]期LIGHTWAVE研究的結果。不幸的是，根據WAIS-IV 編碼測試（主要終點）的評估，使用達扎南多治療的參與者與安慰劑治療的參與者相比，從基線到第84 天沒有統計學上的顯著差異。

A difference between dalzanemdor and placebo was also not observed for secondary endpoints. Given these results, we do not plan to pursue further clinical development of dalzanemdor in Alzheimer's disease. While we are disappointed by the findings from the LIGHTWAVE Study, we extend our gratitude to all the participants, investigators, care partners, patient advocates, and the broader Alzheimer's community, all of whom contributed to this important research.

達札南多和安慰劑之間的次要終點也沒有觀察到差異。鑑於這些結果，我們不打算進一步進行達札南多治療阿茲海默症的臨床開發。雖然我們對光波研究的結果感到失望，但我們向所有參與者、研究人員、護理合作夥伴、患者倡導者和更廣泛的阿茲海默症社區表示感謝，他們都為這項重要的研究做出了貢獻。

We are also conducting the Phase 2 DIMENSION Study that evaluates dalzanemdor in people with cognitive impairment associated with Huntington's disease. This cognitive impairment affects the ability of people with Huntington's disease to work and care for themselves, and there are currently no treatments. We look forward to the top-line data from the DIMENSION Study which are expected later this year.

我們也正在進行 2 期 DIMENSION 研究，評估達札南多對亨廷頓氏症相關認知障礙患者的療效。這種認知障礙會影響亨丁頓舞蹈症患者的工作和照顧自己的能力，目前尚無治療方法。我們期待 DIMENSION 研究的主要數據，預計今年稍後將獲得。

We continue to evaluate options across our early-stage pipeline, including what I'll highlight today, SAGE-319. This work is built on the insight that alterations in inhibitory GABA signaling may play an important role in the pathophysiology of many brain health disorders. SAGE-319 is an extra-synaptic preferring GABAA receptor, positive allosteric modulator or PAM, that is designed to be differentiated from the other GABA PAMs in our portfolio. With SAGE-319, we see an opportunity to treat certain neurodevelopmental disorders where current treatment options are limited.

我們繼續評估早期管道中的選項，包括我今天要強調的 SAGE-319。這項工作建立在這樣的認識之上：抑制性 GABA 訊號傳導的改變可能在許多大腦健康疾病的病理生理學中發揮重要作用。SAGE-319 是一種突觸外偏好的 GABAA 受體、正變構調節劑或 PAM，旨在與我們產品組合中的其他 GABA PAM 區分開來。透過 SAGE-319，我們看到了治療某些目前治療選擇有限的神經發育障礙的機會。

I want to close on a note of appreciation for the hard work and dedication of our teams. They are on the front lines with advancing our understanding of the treatment of brain health disorders.

最後，我想對我們團隊的辛勤工作和奉獻精神表示感謝。他們處於推進我們對大腦健康疾病治療理解的第一線。

Now, I will turn the call over for a review of our financials.

現在，我將轉交電話以審查我們的財務狀況。

Kimi?

基米？

Thanks, Laura.

謝謝，勞拉。

Our financial results for the third quarter 2024 are detailed in our press release issued this afternoon. As Chris mentioned, we reported collaboration revenue from the sales of ZURZUVAE of $11 million in the third quarter. As a reminder, our reported collaboration revenue is 50% of the net revenues Biogen reports for ZURZUVAE. Note that certain variables in the fourth quarter, including [holidays] could influence revenue.

我們今天下午發布的新聞稿詳細介紹了 2024 年第三季的財務表現。正如 Chris 所提到的，我們報告第三季 ZURZUVAE 銷售的合作收入為 1,100 萬美元。提醒一下，我們報告的合作收入是 Biogen 報告的 ZURZUVAE 淨收入的 50%。請注意，第四季度的某些變量，包括[假期]，可能會影響收入。

Turning to operating expenses. R&D expenses were $54.6 million in the third quarter of 2024. SG&A expenses were $53.2 million in the third quarter of 2024. We expect operating expenses to decrease in 2025 relative to 2024.

轉向營運費用。2024 年第三季研發費用為 5,460 萬美元。2024 年第三季的 SG&A 費用為 5,320 萬美元。我們預計 2025 年營運費用將較 2024 年下降。

Our net loss for the third quarter of 2024 was $93.6 million. We ended the third quarter of 2024 with cash, cash equivalents, and marketable securities of approximately $569 million.

我們 2024 年第三季的淨虧損為 9,360 萬美元。截至 2024 年第三季末，我們的現金、現金等價物及有價證券約為 5.69 億美元。

As we state in our reorganization announcement earlier this month, we anticipate that implementation of the reorganization will extend our cash runway and we plan to update cash runway guidance in the near future.

正如我們在本月稍早的重組公告中所述，我們預計重組的實施將延長我們的現金跑道，並計劃在不久的將來更新現金跑道指導。

Finally, I want to thank my colleagues for the opportunity to work alongside you as we built a company with a tremendous team. I'm proud of our efforts, especially in revolutionizing the approach to postpartum depression. It's been a privilege to make an impact in this area and I wish you all continued success.

最後，我要感謝我的同事給了我們與你們一起工作的機會，因為我們建立了一家擁有強大團隊的公司。我為我們的努力感到自豪，尤其是在徹底改變產後憂鬱症治療方法方面。能夠在這一領域產生影響是我的榮幸，我祝福大家繼續取得成功。

I'll now turn it over to Katie to handle Q&A with the operator.

我現在將把它交給凱蒂來處理與接線員的問答。

Katie?

凱蒂？

Thanks, Kimi.

謝謝，基米。

(event instructions)

（活動說明）

Now, I will turn it over to the operator to oversee Q&A.

現在，我將把它交給接線員來監督問答。

Operator?

操作員？

(Operator Instructions)

（操作員說明）

Anupam Rama, JP Morgan.

阿努帕姆‧拉瑪，摩根大通。

I know it's only been a few weeks but wondering what color you can provide on what you're seeing on script trends from the sales force expansion. Thanks so much.

我知道這才過了幾週，但我想知道您可以為您所看到的銷售隊伍擴張的腳本趨勢提供什麼顏色。非常感謝。

Hey, Anupam. Thanks, appreciate it.

嘿，阿努帕姆。謝謝，感激不盡。

So as we highlighted in the prepared remarks, we put the sales force in for the fourth quarter. So they're out there in the field. Given the promotional sensitivity we've seen with the territories that we're already, we're confident that we're going to see an uptick with these, but it's too early to provide any guidance or color other than they're in the field and operating effectively.

因此，正如我們在準備好的發言中所強調的那樣，我們在第四季度投入了銷售人員。所以他們就在現場。考慮到我們已經在這些地區看到的促銷敏感性，我們有信心這些地區的促銷活動將會有所增加，但現在提供除它們之外的任何指導或顏色還為時過早。 。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Hi guys. This is Shrunatra on for Salveen. Thanks for taking our question.

嗨，大家好。這是Shrunatra 為Salveen 做的。感謝您提出我們的問題。

Just a couple from our side. Could you speak to your early-stage pipeline? And if we'll be seeing any data there next year or the indications for SAGE-319. And also regarding the Specialty Pharma process for ZURZUVAE, any color on the optimization there. And if there's been any reduction in the lag between the prescription through the (inaudible) shift.

我們這邊只有一對夫婦。能談談您的早期研發管線嗎？明年我們是否會看到任何數據或 SAGE-319 的跡象。還有關於 ZURZUVAE 的專業製藥流程，那裡的優化有任何顏色。處方與（聽不清楚）轉變之間的延遲是否有任何減少。

Let me start with the Specialty Pharma and ZURZUVAE and then I'll turn it over to Laura to talk about the pipeline.

讓我從 Specialty Pharma 和 ZURZUVAE 開始，然後我將把它交給 Laura 來討論管道。

So as we talked about in the last quarter, working with Specialty Pharma is newer to the OB/GYNs and just to be clear, OB/GYNs and that health care provider office is the right place to intercept PPD for moms early in the disease progress. So as we educate and implement additional solutions, that process is getting better and better. We're not really hearing much complaints about drug getting shipped to mom's homes. In fact, it's a very efficient process that continues to improve quarter on quarter.

因此，正如我們在上個季度談到的，與專業製藥公司合作對於婦產科醫生來說是較新的事情，需要明確的是，婦產科醫生和醫療保健提供者辦公室是在疾病進展早期為媽媽們攔截PPD 的正確場所。因此，當我們教育和實施更多解決方案時，這個過程會變得越來越好。我們並沒有真正聽到太多關於毒品被運送到媽媽家裡的投訴。事實上，這是一個非常有效率的流程，並且逐季持續改進。

Laura, you want to talk about the early-stage pipeline.

勞拉，你想談談早期的管道。

Yeah, sure.

是的，當然。

So as I highlighted on the call, one of the interesting compounds in our early-stage pipeline is SAGE-319 and that differentiates from other equity in our GABA portfolio because it is an extra-synaptic preferring molecule. And so, as compared to benzodiazepines or to our prior GABA compounds that have been in development, it has a different pharmacological profile that we hope will translate into a different profile in the clinic.

正如我在電話會議上強調的那樣，我們早期研發管線中一個有趣的化合物是 SAGE-319，它與我們 GABA 投資組合中的其他股票不同，因為它是一種突觸外偏好分子。因此，與苯二氮平類藥物或我們先前開發的 GABA 化合物相比，它具有不同的藥理學特徵，我們希望將其轉化為不同的臨床特徵。

In preclinical data, we have seen that this compound behaves differently than benzodiazepines and the balance to GABA compounds. And it is currently in Phase 1 and we look forward to starting to uncover some of the information about how this molecule will differentiate in the clinic during the Phase 1 program.

在臨床前數據中，我們發現該化合物的行為不同於苯二氮平類藥物以及與 GABA 化合物的平衡。目前它正處於第一階段，我們期待在第一階段計劃中開始揭示有關該分子如何在臨床中區分的一些資訊。

With regard to the rest of the early pipeline, the approach that we've taken to develop our pipeline is to really understand the role of neurosteroids in impacting brain circuitry. And we've started with the GABAA platform and followed with the NMDA platform. But these are just two examples of how neurosteroids could influence very circuitry in the brain. And so in our earlier stage pipeline, we're looking to identify other opportunities for neurosteroids for a platform approach.

關於早期管道的其餘部分，我們開發管道所採取的方法是真正了解神經類固醇在影響大腦迴路中的作用。我們從 GABAA 平台開始，然後是 NMDA 平台。但這只是神經類固醇如何影響大腦迴路的兩個例子。因此，在我們的早期階段，我們正在尋找神經類固醇平台方法的其他機會。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

First of all, Kimi, it's been great working with you and you'll be greatly missed. Same goes to Chris to all of you. And thank you for your contribution at Sage, just want to maybe start that.

首先，Kimi，與你一起工作非常愉快，我們會非常想念你。克里斯對你們所有人也是如此。感謝您對 Sage 的貢獻，只是想開始。

And in terms of my question, I guess given the setbacks recently around pipeline products, what evidence can you point us to get clients excited going into the Huntington's disease read-out here at year end? Appreciate color.

就我的問題而言，我想考慮到最近在管道產品方面遇到的挫折，您能向我們指出什麼證據可以讓客戶對年底的亨廷頓舞蹈症讀數感到興奮？欣賞色彩。

Yeah, thanks. And Kimi's going to look forward to her retirement but certainly done a wonderful job helping to build Sage.

是的，謝謝。Kimi 即將退休，但在幫助建立 Sage 方面確實做得非常出色。

Let me start and then I'll ask Laura to talk about [Huntington's] some of the earlier data we saw. So look we -- as you heard in the call, we're off to a very strong start with the launch of ZURZUVAE in PPD. And we think seeing that continued growth of shipments quarter to quarter and really the transformation of PPD is very exciting for us.

讓我開始吧，然後我會請勞拉談談我們之前看到的一些[亨廷頓]數據。所以，正如您在電話中聽到的那樣，隨著 ZURZUVAE 在 PPD 的推出，我們有了一個非常強勁的開端。我們認為，看到出貨量逐季度持續成長以及 PPD 的轉型對我們來說非常令人興奮。

Additionally, we have an earlier stage pipeline that we've already commented on and seeing those data move along, we think, create a short-, medium-, and potentially longer-term value as we follow the science there and apply all the lessons learned from all the compounds we've already got data on to earlier stage compounds. We were learning a lot over the last four years and applying those learnings for earlier stage pipeline. You should see some different thinking moving forward there.

此外，我們已經對早期階段的管道進行了評論，並看到這些數據不斷發展，我們認為，隨著我們遵循那裡的科學並應用所有經驗教訓，創造短期、中期和潛在的長期價值從我們已經獲得在早期化合物數據的所有化合物中了解到。在過去的四年裡，我們學到了很多東西，並將這些知識應用於早期階段的管道。你應該會看到一些不同的想法在向前發展。

Laura, you want to talk about dalzanemdor and Huntington's and some of the earlier data and some of the hope we have for the upcoming data readout?

勞拉（Laura），您想談談達扎內姆多（dalzanemdor）和亨廷頓舞蹈病（Huntington's）以及一些早期數據以及我們對即將到來的數據讀出的一些希望嗎？

Sure.

當然。

So for those who may not be familiar, the DIMENSION Study is our study of dalzanemdor in patients with Huntington's disease who have cognitive impairment. And we are expecting results from that study before the end of the year. We have a very strong scientific rationale for this study that relies on really two approaches.

對於可能不熟悉的人來說，DIMENSION 研究是我們對患有認知障礙的亨廷頓舞蹈症患者使用達札南多進行的研究。我們預計研究的結果將在今年年底前得到。我們對這項研究有非常強有力的科學依據，它實際上依賴兩種方法。

The first is decades of research into the role of the NMDA receptor in learning and memory. And the second is a later recognition that a neuroactive steroid, 24S-hydroxycholesterol, is reduced in patients with Huntington's. Now, this is a neurosteroid that binds to the NMDA receptor and modulates it. And we expect that dalzanemdor -- dalzanemdor could be expected to modulate the receptor in the same way, restoring the function of the NMDA of the system towards normal.

首先是對 NMDA 受體在學習和記憶中的作用進行了數十年的研究。第二個是後來認識到神經活性類固醇 24S-羥基膽固醇在亨廷頓氏舞蹈症患者中會減少。現在，這是一種神經類固醇，可以與 NMDA 受體結合並對其進行調節。我們預期 dalzanemdor 可能會以相同的方式調節受體，使系統的 NMDA 功能恢復正常。

One of the interesting factors of study in Huntington's disease is that it is a genetically defined in younger population than what we've seen in some of our other studies. That means this population is more homogeneous, that has fewer medical comorbid disease, and as a consequence, it's easier to detect a signal in this population.

亨廷頓舞蹈症研究的一個有趣因素是，與我們在其他一些研究中看到的情況相比，亨廷頓舞蹈症是在年輕族群中進行基因定義的。這意味著該族群更加同質，合併症較少，因此更容易檢測到該族群中的訊號。

So as we said, we don't anticipate that the results we've seen in prior studies will necessarily predict the results from DIMENSION. We're looking forward to seeing the results from those studies later this year.

因此，正如我們所說，我們預計我們在先前的研究中看到的結果不一定能預測 DIMENSION 的結果。我們期待在今年稍後看到這些研究的結果。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Thanks for providing this update.

感謝您提供此更新。

Could you please talk about the Talkiatry collaboration that Biogen has initiated and the potential for that opportunity to drive uptake and PPD through telehealth? Thank you.

您能否談談 Biogen 發起的 Talkiatry 合作以及該機會透過遠距醫療推動採用和 PPD 的潛力？謝謝。

Yeah, Jay, that's a great question. I'll start and I'll ask Chris to talk about it.

是的，傑伊，這是一個很好的問題。我先開始，然後請克里斯談談。

So as we think about the paradigm shift, we're trying to drive in PPD, it really does start with those that see moms before, during, and then obviously at the birthing event and then directly after the pregnancy. And that is OB/GYNs and nurse practitioners and physician assistants that help them.

因此，當我們考慮範式轉變時，我們正在努力推動 PPD，它確實從那些在分娩前、分娩過程中、然後顯然是在分娩時以及懷孕後直接見到媽媽的人開始。這就是幫助他們的婦產科醫師、執業護理師和醫師助理。

So that's the right time frame in place to screen. And then if properly diagnosed, diagnose and treat. And as you saw from this quarter, over 70% of the scripts are in fact coming from OB/GYN. So we are intercepting PPD early in the disease process. That's great. Some women don't get screened and diagnosed and others frankly don't go on to develop symptoms until multiple months after birth.

所以這是篩選的正確時間範圍。然後，如果診斷正確，則進行診斷和治療。正如您從本季度看到的，超過 70% 的腳本實際上來自婦產科。因此，我們在疾病過程的早期就攔截 PPD。那太棒了。有些女性沒有接受篩檢和診斷，而有些女性則坦白說，直到出生後幾個月才出現症狀。

So they're outside the practice of OB/GYN. So it's important for us to -- for us to have access and educate psychiatrists and primary care physicians so that those moms that have gotten out of the OB/GYN potential screening and diagnosis can get treatment for their PPD symptoms if diagnosed. And that's really where the other disease -- the other specialties come in as well as Talkiatry.

所以它們不屬於婦產科實務範圍。因此，對我們來說，重要的是我們能夠接觸和教育精神科醫生和初級保健醫生，以便那些已經擺脫婦產科潛在篩檢和診斷的媽媽們在確診後能夠得到針對 PPD 症狀的治療。這確實是另一種疾病——其他專業以及 Talkiatry 發揮作用的地方。

Chris, you want to talk further about that.

克里斯，你想進一步討論這個問題。

Barry, I think, you hit it. Telehealth and organizations like Talkiatry are a much needed resource for new mothers as they navigate the challenges of motherhood and effectively what they do is they need that woman at a place in time where she needs supportive care, she's able to do so from whatever environment that she's in. So we really believe, I think as you said that this is going to expand the opportunity for so many women to engage with health care professionals and gain deeper insight into how to manage through their postpartum depression.

巴里，我想，你成功了。遠距醫療和像Talkiatry 這樣的組織對於新手媽媽來說是非常需要的資源，因為她們需要應對母親的挑戰，而她們所做的實際上是，她們需要在需要支持性護理的地方及時幫助女性，她能夠在任何環境中做到這一點。因此，我們真的相信，正如您所說，這將擴大許多女性與醫療保健專業人員接觸的機會，並更深入地了解如何應對產後憂鬱症。

Yeah, and Jay, I think you highlighted this in terms of further uptake. It might take in certain areas of the country, weeks to months to get into a psychiatrist. So this provides immediate access should a mom really need that help that Chris just highlighted.

是的，傑伊，我認為你在進一步吸收方面強調了這一點。在該國的某些地區，可能需要幾週到幾個月的時間才能去看精神科醫生。因此，如果媽媽確實需要克里斯剛才強調的幫助，這可以立即提供幫助。

Ritu Baral, TD Cowen.

裡圖·巴拉爾，TD·考恩。

Hi. This is Athena on for Ritu. Thanks for taking the question.

你好。這是雅典娜為 Ritu 配音的節目。感謝您提出問題。

Another on your early-stage pipeline. What is your timeline to unveiling promising early-stage assets with cost effective development? And would these assets also be neuro focused or neuropsych focused? Thank you.

您的早期管道中的另一個。您推出具有成本效益的開發的有前途的早期資產的時間表是什麼？這些資產也會以神經為中心或以神經心理學為中心嗎？謝謝。

Thanks for your question, Athena.

謝謝你的提問，雅典娜。

Let me ask Laura to start and then Mike might want to chime in there as well.

讓我請勞拉開始，然後麥克也可能想插話。

Yeah. So right now we are in the process of evaluating all of the potential assets across our portfolio and are conducting a portfolio prioritization process. When that is complete, we will share more the details about the early pipeline.

是的。因此，現在我們正在評估我們投資組合中的所有潛在資產，並正在進行投資組合優先順序確定過程。完成後，我們將分享更多有關早期管道的詳細資訊。

And then just to build a little bit on what Laura said earlier, I think from the beginning of Sage, there were two elements that we really focused in on and trying to understand the best way to bring forward new medicines and brain health disorders.

然後，在 Laura 之前所說的基礎上，我認為從 Sage 開始，我們真正關注的有兩個要素，並試圖了解提出新藥物和大腦健康疾病的最佳方法。

And one as Laura mentioned was understanding how the neuropathology of neural circuits and role neural circuits play across a range of brain health disorders. And the other one is really around our in-house chemistry platform that's focused on understanding usually neuroactive steroids, but I think more broadly endogenous steroids and how they engage those neural circuits.

勞拉提到的一個問題是了解神經迴路的神經病理學以及神經迴路在一系列大腦健康疾病中的作用。另一個實際上是圍繞我們的內部化學平台，該平台專注於了解通常具有神經活性的類固醇，但我認為更廣泛的是內源性類固醇以及它們如何參與這些神經迴路。

And so while we focus -- our clinical pipeline right now is really emphasized the GABA and NMDA receptors as critical ways of interacting with these neural circuits, we've also been working on research and understanding the other endogenous pathways within our chemistry platform that can engage these circuits that go beyond just the GABA and NMDA receptor. And as we continue to evaluate those opportunities, we'll have more information to share.

因此，雖然我們現在的臨床管道確實強調 GABA 和 NMDA 受體作為與這些神經迴路相互作用的關鍵方式，但我們也一直致力於研究和了解我們的化學平台中的其他內源性途徑，這些途徑可以參與這些不僅是GABA 和NMDA 受體的迴路。隨著我們繼續評估這些機會，我們將有更多資訊可供分享。

Ami Fadia, Needham.

阿米法迪亞，尼達姆。

With regards to some of the efforts in conjunction with Biogen to support women that are ending up being treated by a psychiatrist rather than an OB/GYN, can you just step back and give us a sense of how the market dynamics or how the market is split with regards to the number of women that actually get seen by an OB/GYN versus a psychiatrist and help us understand also from the sense of the severity of PPD, if you've been able to get a better sense of how the severity level of these patients differs across the market, that would be helpful. Thank you.

關於與百健 (Biogen) 合作為支持最終接受精神科醫生而不是婦產科醫生治療的女性所做的一些努力，您能否退後一步，讓我們了解市場動態或市場狀況如何實際接受婦產科醫生和精神科醫生檢查的女性人數的差異，如果您能夠更好地了解嚴重程度，也可以幫助我們從產後憂鬱症的嚴重程度來理解這些患者的數量在整個市場上有所不同，這會有所幫助。謝謝。

Yeah, Amy, thanks for the question. That's a good one.

是的，艾米，謝謝你的提問。這是一件好事。

So just the numbers, as we've highlighted, over 70% of the prescriptions are coming from OB/GYN, which we think is the right place to intercept PPD. PPD like any disease, the earlier in the disease onset, you can treat the better off typically the outcomes. And as we all know that -- undertreated mom has devastating consequences, not just for mom, but for baby.

因此，正如我們所強調的那樣，僅從數字來看，超過 70% 的處方來自婦產科，我們認為這是攔截 PPD 的正確位置。PPD 與任何疾病一樣，疾病發病越早，治療效果通常就越好。眾所周知，媽媽受到不當對待會帶來毀滅性的後果，不僅對媽媽，而且對寶寶。

So the ideal state is in during pregnancy or directly after the baby is born for the OB/GYN office to be the primary spot of standard screening and if appropriate diagnosis and then if appropriate treatment with an intervention.

因此，理想的狀態是在懷孕期間或嬰兒出生後，婦產科辦公室成為標準篩檢的主要地點，如果適當的話進行診斷，然後在適當的情況下進行幹預治療。

What we're seeing and we highlighted this in the remarks is that once a OB/GYN uses ZURZUVAE, they're seeing more PPD and they're using ZURZUVAE more often than not and seeing that PPD. So that's the dynamic we want to create.

我們所看到的以及我們在評論中強調的一點是，一旦 OB/GYN 使用 ZURZUVAE，他們就會看到更多的 PPD，而且他們使用 ZURZUVAE 的頻率會更高，並且會看到 PPD。這就是我們想要創造的動力。

Now as we highlighted, not every mom with PPD gets picked up in the weeks being treated by OB/GYN and several women develop symptoms, weeks or months after delivering a baby that are PPD symptoms. And that's where primary care and psychiatry comes in. But just to be clear, our real focus is to continue to grow awareness in the OB/GYN office because that's the right primary intervention for PPD. And we want to continue to see the scripts flowing from OB/GYNs.

現在，正如我們所強調的那樣，並不是每個患有產後憂鬱症的媽媽都會在接受婦產科治療的幾週內被發現，而且有些女性在產後幾週或幾個月後會出現產後憂鬱症症狀。這就是初級保健和精神病學發揮作用的地方。但需要明確的是，我們真正的重點是繼續提高對婦產科辦公室的意識，因為這是針對 PPD 的正確主要幹預措施。我們希望繼續看到來自婦產科醫生的腳本。

You also asked about the severity, so let's hit that quickly. So we are seeing mild, moderate, and severe PPD treated at all specialty levels. So it's not really differentiating by specialty. The other thing we're working on from a disease state awareness is really to help the health care community understand that since PPD doesn't really fit into the buckets of mild, medium, severe. A woman could show up on Monday and being diagnosed with mild PPD, only develop severe PPD on Friday. So if someone has PPD, they need to be -- they need an intervention, whether it's another treatment through who they are talk therapy, they need help.

您也詢問了嚴重性，所以讓我們快速解決這個問題。因此，我們看到所有專業級別的輕度、中度和重度產後憂鬱症都得到了治療。所以它並沒有真正按照專業來區分。我們在疾病狀態意識方面所做的另一件事是幫助醫療保健界了解這一點，因為 PPD 並不真正適合輕度、中度、重度的分類。一名女性可能會在周一就診並被診斷出患有輕度產後憂鬱症，但只有在周五才會發展為嚴重的產後憂鬱症。因此，如果有人患有產後憂鬱症，他們需要——他們需要幹預，無論是透過談話療法進行另一種治療，他們都需要幫助。

Brian Abrahams, RBC Capital Markets.

布萊恩‧亞伯拉罕斯 (Brian Abrahams)，加拿大皇家銀行資本市場部。

I'm curious, what will you guys be looking for in DIMENSION on SDMT and across the secondary endpoints in order to move dalzanemdor forward. Would signals and trend -- or trends across all or some of these endpoints be enough? And how is the bar evolved given the decision -- since the decision to restructure and refocus resources? Thanks.

我很好奇，你們會在 SDMT 的 DIMENSION 和次要端點中尋找什麼，以推動 dalzanemdor 向前發展。訊號和趨勢——或者所有或部分端點的趨勢就足夠了嗎？自從做出重組和重新集中資源的決定以來，標準是如何演變的？謝謝。

Hey, Brian. Thanks for the question. I'll ask Laura to start and I'll circle back with [potential digital] color.

嘿，布萊恩。謝謝你的提問。我會請勞拉開始，然後我會用[潛在的數字]顏色繞回來。

Yeah. So in the DIMENSION Study, we have recently adjusted the primary endpoint to the SDMT, the Symbol Digit Modalities Test, and this is a test that's been around for nearly 100 years in multiple forms. Clinicians are aware of it. Regulators are familiar with it, and it's considered a reliable measure of cognition over time.

是的。因此，在 DIMENSION 研究中，我們最近將主要終點調整為 SDMT（符號數位模態測試），這是一項以多種形式存在了近 100 年的測試。臨床醫生都意識到這一點。監管機構對此很熟悉，並且它被認為是隨著時間的推移而可靠的認知衡量標準。

We are looking in the study for obviously a clinically meaningful change between dalzanemdor and placebo on this endpoint. And we'd like to see that supported by meaningful changes on the secondary endpoint, which is an endpoint of function called the independent scale in Huntington's disease and across some of the other secondary endpoints.

我們正在研究中尋找達札南多和安慰劑在這一終點上明顯具有臨床意義的變化。我們希望看到次要終點的有意義的變化支持這一點，這是一個被稱為亨廷頓舞蹈症和其他一些次要終點的獨立量表的功能終點。

Tazeen Ahmad, Bank of America.

塔津·艾哈邁德，美國銀行。

On ZURZUVAE, can you potentially give us a little bit of color on breadth and depth of use? Are most of the scripts coming from physicians who have had experience prescribing it before and are adding to their prescriptions for other patients? And can you just talk about the rate with which you're adding new prescribers now relative to when the launch first started?

關於 ZURZUVAE，您能否給我們一些有關使用廣度和深度的資訊？大多數處方是否來自以前有處方經驗並正在為其他患者添加處方的醫生？您能否談談現在相對於剛開始推出時添加新處方者的速度？

And then to go back to MDD, can you give us a little bit of color on the details around your decision to not pursue MDD? Is it that the trial would be difficult to design or is it more that you feel you want to focus your resources on PPD? Thanks.

然後回到 MDD，能否向我們介紹您決定不追求 MDD 的細節？是因為試驗設計起來比較困難，還是您更希望將資源集中在 PPD 上？謝謝。

Yeah, Tazeen. Good set of questions.

是的，塔津。很好的一組問題。

Let me start with MDD and then I'll provide some comment on ZURZUVAE, but just turn it over to Chris to elaborate further. So in terms of MDD, as we thought about the clinical trials required to generate a potential indication, the risk relative to our portfolio and our resource allocation, we think we're best off continuing to create ZURZUVAE as the key to unlock the blockbuster potential in [PPD] helping more and more moms. That's the right place for us to use our balance sheet, take risk, and spend other money particularly after more focused size of company.

讓我從 MDD 開始，然後我將對 ZURZUVAE 提供一些評論，但將其交給 Chris 進一步詳細說明。因此，就MDD 而言，當我們考慮產生潛在適應症所需的臨床試驗、與我們的投資組合相關的風險以及我們的資源分配時，我們認為我們最好繼續創建ZURZUVAE 作為釋放重磅炸彈潛力的關鍵在[PPD]幫助越來越多的媽媽。這是我們使用資產負債表、承擔風險和花費其他資金的正確場所，特別是在公司規模更加集中之後。

In terms of -- and obviously Biogen also aligns with that decision.

顯然，百健（Biogen）也同意這項決定。

In terms of ZURZUVAE, our strategy is to drive both breadth and depth of prescribers. So our field force, our non-perishable motion, our marketing, our direct-to-consumer are all out there drawing breadth and depth.

就 ZURZUVAE 而言，我們的策略是推動處方者的廣度和深度。因此，我們的現場工作人員、我們的不易腐爛的運動、我們的行銷、我們的直接面向消費者都在不斷擴大廣度和深度。

Chris, you want to provide some more color.

克里斯，你想提供更多的色彩。

Yeah. So Barry, to reinforce what you said, we're seeing ZURZUVAE prescribed across that breadth and depth of prescribers that you mentioned for [pre-PPD]. Obviously, led by OB/GYNs with 70% of prescribers being OB/GYNs that we saw in the third quarter. And many of them are using ZURZUVAE as a first-line therapy.

是的。所以巴里，為了強調你所說的，我們看到你提到的處方者的廣度和深度都開出了 ZURZUVAE[PPD前]。顯然，以婦產科醫生為首，我們在第三季度看到，70% 的處方者是婦產科醫生。其中許多人正在使用 ZURZUVAE 作為一線療法。

So, of course, over time over the course of the quarter, what we see is that prescribers are increasing and repeat utilization of prescriptions are also increasing as physicians gain more experience with this medication. Obviously, that's enabled by the experience they have, the medication working as it did in our pivotal studies when they see it in the real-world setting, supported by the access and reimbursement ecosystem that we have, that enables first-line access for this medication.

因此，當然，隨著本季的時間推移，我們看到，隨著醫生在這種藥物方面獲得更多經驗，處方者正在增加，處方的重複使用也在增加。Obviously, that's enabled by the experience they have, the medication working as it did in our pivotal studies when they see it in the real-world setting, supported by the access and reimbursement ecosystem that we have, that enables first-line access for this藥物.

So in effect, what we have happening here is a number of different commercialization factors coming together enabling breadth and depth of utilization across that group of physicians that we've talked about.

因此，實際上，我們在這裡發生的事情是許多不同的商業化因素結合在一起，從而實現了我們所討論的那組醫生的利用的廣度和深度。

Vikram Purohit, Morgan Stanley.

維克拉姆‧普羅希特，摩根士丹利。

This is Morgan on for Vikram.

這是摩根替維克拉姆上場。

So we have two. First, what magnitude of sales uplift do you think that the recent sales force expansion for ZURZUVAE could drive? And how -- over what period of time in terms of months or quarters do you think it'll take to see this pull through?

所以我們有兩個。首先，您認為 ZURZUVAE 最近的銷售團隊擴張可以帶來多大程度的銷售提升？您認為需要多長時間（幾個月或幾季）才能實現這一目標？

And then our second question is, do you think that the current ZURZUVAE sales force is rightly sized or could there be any additional investments into the sales force in 2025?

然後我們的第二個問題是，您認為目前 ZURZUVAE 銷售團隊的規模是否合適，或者在 2025 年是否會對銷售團隊進行任何額外投資？

Thank you.

謝謝。

Morgan, that was actually three questions. Way to get it in there. I'll start and I'll ask Chris to provide any comments.

摩根，這其實是三個問題。方法就是把它放進去。我將開始並請克里斯提供任何意見。

So just to back up when we thought about the launch, we thought very big about the potential of PPD and we've said it a number of times. We see the blockbuster potential in ZURZUVAE helping many, many women suffering with PPD.

因此，當我們考慮推出這款產品時，我們非常重視 PPD 的潛力，我們已經說過很多次了。我們看到 ZURZUVAE 的巨大潛力可以幫助許多患有產後憂鬱症的女性。

The epidemiology, the diagnosis rates, treatment rates support this and we're already seeing tremendous use of ZURZUVAE front line by many of those health care providers educated. So we're off to a really strong start with a third full growth.

流行病學、診斷率、治療率都支持這一點，我們已經看到許多受過教育的醫療保健提供者在前線大量使用 ZURZUVAE。因此，我們有了一個非常強勁的開端，實現了第三次全面成長。

The field force is calling on targets, some of whom have been called on, some of who not, those calls on we should see immediate impact. Those newer ones might take one or two or three calls to see the impact, but it shouldn't -- we should be seeing some impact next quarter.

現場部隊正在對目標進行號召，其中一些已被號召，有些則沒有，這些號召我們應該會立即看到影響。那些較新的可能需要一兩個或三個電話才能看到影響，但這不應該——我們應該在下個季度看到一些影響。

And then in terms of growth, we see growth quarter to quarter here for a pretty extended period of time. I can't really provide a forecast or guidance there. But again, based upon the numbers, epidemiologically half women a year are -- suffer from PPD, less than half of those are diagnosed and less or half of those are treated. We're trying to change all of that. The number of treated with ZURZUVAE, the increased diagnosis, and the increased awareness. So we see this continuing to grow for an extended period of time quarter on quarter.

然後就成長而言，我們看到在相當長的一段時間內逐季成長。我無法真正提供預測或指導。但同樣，根據這些數字，從流行病學角度來看，每年有一半的女性患有產後憂鬱症，只有不到一半的女性得到診斷，只有不到一半的女性得到治療。我們正在努力改變這一切。ZURZUVAE 治療人數、診斷數量和意識提高。因此，我們看到這一數字在很長一段時間內逐季持續成長。

As we see success, we might continue to invest in DTC marketing, non-personal promotion, including additional sales force expansion if it's warranted and will drive further success.

當我們看到成功時，我們可能會繼續投資 DTC 行銷、非個人促銷，包括額外的銷售團隊擴張（如果有必要的話）並將推動進一步的成功。

What I would add, Barry, is that what we've learned very quickly is this is a promotionally responsive market. It's promotionally responsive to field force effort. It's promotionally responsive to non-personal efforts, which is why we're investing in both of these as we go forward. We want to certainly make sure that if there is opportunity that we're capitalizing on that opportunity right now and I think you hit it, we'll continue to assess the investments required to grow the market as we move forward. But again, through promotional responsiveness and what we've learned, the time is right right now to be doing the things that we're doing.

巴里，我要補充的是，我們很快就了解到這是一個促銷敏感的市場。它對現場人員的努力做出了積極的回應。它對非個人努力做出促銷反應，這就是為什麼我們在前進的過程中對這兩個方面進行投資。我們當然希望確保，如果我們現在正在利用這個機會，並且我認為您抓住了這個機會，那麼我們將在前進的過程中繼續評估發展市場所需的投資。但同樣，透過促銷反應和我們所學到的知識，現在是時候做我們正在做的事情了。

Uy Ear, Mizuho.

Uy Ear，瑞穗。

So first question is, could you maybe elaborate a bit on coverage, particularly with, I guess, Medicaid reviews? I think in the last quarter, you were saying that several large states were conducting reviews. I was just wondering, how much more coverage have you gotten from Medicaid versus commercialized?

所以第一個問題是，您能否詳細說明一下保險範圍，特別是我想醫療補助的評論？我想在上個季度，您說幾個大州正在進行審查。我只是想知道，與商業化醫療補助相比，您獲得的保險範圍多了多少？

And second question, would you give the number of prescriptions that were written in 3Qs? I might have missed; I didn't see in the press release. Thanks.

第二個問題，您能給出 3Q 中開出的處方數量嗎？我可能錯過了；我在新聞稿中沒有看到。謝謝。

Yeah, I, I'll start and then I'll ask Chris to comment.

是的，我，我會開始，然後我會請克里斯發表評論。

So last quarter, we highlighted that we were going to provide shipments and revenues going forward and drop prescriptions, so we've done that. In terms of coverage, I characterize coverage is way ahead of schedule in terms of where we are launched, both in terms of a commercial PBM and Medicaid.

因此，上個季度，我們強調我們將提供未來的出貨量和收入並放棄處方，所以我們已經做到了。就覆蓋範圍而言，我認為就我們的推出而言，無論是商業 PBM 還是醫療補助，覆蓋範圍都遠遠超出了計劃。

But Chris, you want to provide more color.

但是克里斯，你想提供更多的色彩。

I mean, it's a part of our strategy, Barry. What we've historically said is that access and reimbursement is paramount to a successful launch, which is why we've worked so hard on ensuring that in this area, both with respect to commercial plans as well as Medicaid.

我的意思是，這是我們策略的一部分，巴瑞。我們歷來說過，獲取和報銷對於成功啟動至關重要，這就是為什麼我們在商業計劃和醫療補助方面如此努力確保這一領域的實現。

What we've seen is that approximately 90% of all commercial Medicaid lives are now covered with a vast majority of really the policies enabling first-line access to ZURZUVAE without burdensome prior authorizations. Again, it was a goal for us as we set out to launch this medication.

我們所看到的是，現在大約 90% 的商業醫療補助生活都涵蓋了絕大多數真正的保單，無需繁瑣的事先授權即可一線獲得 ZURZUVAE。同樣，當我們著手推出這種藥物時，這也是我們的一個目標。

I think with regard to Medicaid and the specificity of Medicaid, while we haven't given out the exact percentages of Medicaid, what we can say is the majority of Medicaid plans for which we've worked -- there is a pathway to the utilization of ZURZUVAE again in the sense of no prior -- no onerous prior authorizations and no step at it.

我認為關於醫療補助和醫療補助的特殊性，雖然我們沒有給出醫療補助的確切百分比，但我們可以說的是我們所參與的大多數醫療補助計劃 - 有一條利用途徑ZURZUVAE 再次是在沒有事先的意義上－沒有繁瑣的事先授權，也沒有採取任何步驟。

So regardless of whether you're a commercially insured patient or you're someone with Medicaid, there's a high likelihood that not only are you able to get this medication, but you get it in the first line and you're able to do so rather affordably, so very encouraged by what we've seen so far, more work clearly to be done. And as I think the other thing that we said earlier today is that we now have three national PBMs, so the wins in our sales from a market access perspective.

因此，無論您是有商業保險的患者還是享受醫療補助的人，您都很有可能不僅能夠獲得這種藥物，而且您可以在第一線獲得它並且能夠這樣做相當實惠，我們對迄今為止所看到的情況感到非常鼓舞，顯然還有更多工作要做。我認為我們今天早些時候所說的另一件事是，我們現在擁有三個國家 PBM，因此從市場准入的角度來看，我們的銷售取得了勝利。

Danielle Brille, Raymond James.

丹妮爾·布里勒，雷蒙德·詹姆斯。

Hey guys, this is Alex on for Danielle. Thanks for taking the question.

大家好，我是亞歷克斯為丹妮爾代言。感謝您提出問題。

Question on through ZURZUVAE. Just wondering how much insight you have into the ZURZUVAE patient demographics. Just curious if you have any visibility whether ZURZUVAE is being prescribed to mothers with a prior history of PPD or MDD for that matter. And additionally, curious whether you're able to see a breakdown of percent of patients prescribed ZURZUVAE who are first-time mothers versus those having their second or third child, for example. Thanks.

透過 ZURZUVAE 提出問題。只是想知道您對 ZURZUVAE 患者人口統計有多少了解。只是好奇您是否了解 ZURZUVAE 是否正在向有產後憂鬱症或重度憂鬱症病史的母親開處方。此外，您是否能夠看到首次當媽媽的患者與生第二個或第三個孩子的患者中服用 ZURZUVAE 的患者百分比的詳細情況，例如，您是否感到好奇。謝謝。

Yeah, Alex, thanks for the question. Chris, you want to start.

是的，亞歷克斯，謝謝你的提問。克里斯，你想開始嗎？

So what I would say about what we know about patients, we actually know quite a bit. The mix of patients that we see some do have a prior history of major depressive disorder and a significant group of the patient population has no prior history. They're new to the experience of postpartum depression. But also say that across severity types, mild, moderate, or severe, we're seeing utilization of ZURZUVAE without focus on any one of those particular areas. And I think what's really important about that is it says that clinicians aren't making a determination based upon severity from a scale. They're really assessing the needs of the mother when she presents in front of them with the signs and symptoms of PPD while also taking into consideration prior history.

所以我要說的是我們對患者的了解，我們實際上了解很多。我們看到的一些患者確實有重度憂鬱症既往病史，而且有很大一部分患者群體沒有既往病史。他們對產後憂鬱症的經驗還很陌生。但也要說的是，在不同的嚴重程度類型（輕度、中度或重度）中，我們看到 ZURZUVAE 的使用並未關注任何特定領域。我認為真正重要的是，它表明臨床醫生並沒有根據量表的嚴重程度做出決定。當母親在他們面前展示產後憂鬱症的徵兆和症狀時，他們實際上是在評估母親的需求，同時也考慮到先前的病史。

So what we have effectively happening here is that mothers with PPD have access to this medication. As I said, they have access with -- to ZURZUVAE as a first-line therapy in many cases, which is really exciting because what it means is that there's the ability to fundamentally change the way PPD is not only thought about in terms of screening and diagnosis, but the way it's ultimately treated.

因此，我們實際上正在發生的事情是，患有產後憂鬱症的母親可以獲得這種藥物。正如我所說，在許多情況下，他們可以使用 ZURZUVAE 作為一線療法，這確實令人興奮，因為這意味著有能力從根本上改變 PPD 的思考方式，而不僅僅是在篩檢方面和診斷，但最終的治療方式。

Yeah, just to round that out, I guess, to take the opposite side of that, Alex, we're not seeing ZURZUVAE limited to prior history or not -- or limited to severity. It's being used across all kinds of PPD, including new mothers or mothers with, as I said, their second or third or more Children, which is great. That's the dynamic we want to see.

是的，為了完善這一點，我想，從相反的角度來看，亞歷克斯，我們沒有看到 ZURZUVAE 僅限於以前的歷史或不限於嚴重性。它被用於各種產後憂鬱症，包括新手媽媽或有第二個、第三個或更多孩子的母親，這很棒。這就是我們希望看到的動態。

Joel Beatty, Baird.

喬爾·比蒂，貝爾德。

Maybe a follow-up to the last question is how is the use of ZURZUVAE in patients who are already on a treatment for depression? Is that a setting for growth and do OB/GYN feel comfortable prescribing there or is that more a setting who has ever been managing the depression?

也許最後一個問題的後續問題是 ZURZUVAE 在已經接受憂鬱症治療的患者中的使用效果如何？這是一個促進成長的環境嗎？

Yeah, Joel. So what we're seeing again, the majority of scripts over 70% are coming from OB/GYNs which suggested that as the OB/GYNs do and ACOG guides them to do -- their screening, they need to screen and diagnose for PPD, so we're seeing that.

是的，喬爾。所以我們再次看到，超過 70% 的大多數腳本來自婦產科醫生，這表明按照婦產科醫生和 ACOG 指導他們做的篩檢，他們需要篩檢和診斷 PPD，所以我們看到了這一點。

And as we highlighted with the previous question, we're seeing moms being prescribed ZURZUVAE with or without prior history, irrespective of the number the child they had and across all ranges of severity, mild, [moderate], severe which -- we shouldn't be using anyway.

正如我們在上一個問題中所強調的那樣，我們看到媽媽們被開出ZURZUVAE 處方，無論有或沒有既往病史，無論她們生了多少孩子，也無論嚴重程度如何，輕度、[中度]、嚴重－我們應該反正也不會用

We are also seeing ZURZUVAE used as monotherapy on top of an antidepressant that a mom may have been on or reinitiated and concomitant use. So what's really good here is that we're seeing the opportunity for growth across all segments. There's not one segment that's primed for growth, it's really across all these segments. Again, that's exactly what we want to see at this point in launch.

我們也看到 ZURZUVAE 被用作母親可能已經服用或重新開始服用的抗憂鬱藥物以及同時使用的抗憂鬱藥物的單一療法。因此，真正好的一點是，我們看到了所有細分市場的成長機會。沒有一個細分市場已經做好了成長的準備，而是所有這些細分市場都已經做好了成長的準備。同樣，這正是我們在發佈時希望看到的。

Marc Goodman, Leerink.

馬克‧古德曼，萊林克。

Yeah. Two questions.

是的。兩個問題。

One, Barry, on business development, are you looking outside at all for new products or should we be thinking internally developed? And those products that we've talked about in the past that are pre-clinical and moving forward and that's how we should think about your pipeline.

第一，巴里，關於業務發展，您是在外部尋找新產品還是我們應該考慮內部開發？我們過去討論過的那些處於臨床前階段並且正在向前發展的產品，這就是我們應該如何考慮您的管道。

And then just the other question is, can you talk about the inventory change? In the quarter, you were 5.5 weeks last quarter, where are you at the end of the third quarter? And how much revenue did that eat into what you actually reported? Thanks.

另一個問題是，您能談談庫存變化嗎？上季你工作了5.5週，第三季末你在哪裡？這對您實際報告的收入有多少影響？謝謝。

Hey, Mark, thanks for the questions.

嘿，馬克，謝謝你的提問。

I'll take the BD one and ask Chris to talk about inventory. So as we highlighted, we continue to be very intellectually curious and to be frank, anything we've liked that we might want to bring in and others have really liked to, it's gone for pretty significant pieces of equity or cash. So we'll continue to evaluate any potential opportunities that we believe support our business priorities and advance new therapeutic options for patients, including bringing business development in and bringing our pipeline forward. So we are open for opportunities there.

我會拿 BD 一份並請 Chris 談談庫存問題。因此，正如我們所強調的，我們仍然保持著非常強烈的求知欲，坦白說，任何我們喜歡的、我們可能想引入的、其他人真正喜歡引入的東西，都已經消失了相當大的股權或現金。因此，我們將繼續評估任何我們認為支持我們業務重點的潛在機會，並為患者提供新的治療選擇，包括引入業務發展和推進我們的產品線。因此，我們對那裡的機會持開放態度。

Chris, you want to take the inventory piece.

克里斯，你想拿走庫存件。

So with respect to inventory today, we haven't commented on days on hand or weeks on hand or the revenue impact of inventory. But what we can say is that the strong revenue growth in Q3 was largely driven by an increase in demand. And that revenue from ship units to PPD patients increased by approximately 40% in the third quarter. And our belief is that where we stand right now, inventory levels have largely normalized off of where they were from the initial building where exactly where we should be as of the third full quarter of launch.

因此，就今天的庫存而言，我們尚未評論庫存天數或庫存週數或庫存對收入的影響。但我們可以說的是，第三季營收的強勁成長很大程度上是由需求成長所推動的。第三季度，船舶單位向 PPD 患者提供的收入成長了約 40%。我們相信，就我們目前的情況而言，庫存水準已基本正常化，與最初建設時的水平相比，這正是我們在發布的第三個完整季度時應該達到的水平。

Yeah, we'll highlight on the inventory side -- as we continue to -- go ahead, Mark.

是的，我們將重點放在庫存方面——我們將繼續——繼續，馬克。

No, I was going to say, didn't you say that your target was three to four weeks or? I think I heard that maybe last quarter. Is that correct?

不，我想說，你不是說你的目標是三到四個星期嗎？我想我可能是上個季度聽說的。這是正確的嗎？

Yeah. So what I was going to say is -- as we continue to see double digit growth quarter to quarter, the number of units in inventory will obviously grow because to cover three or four weeks at hand, you need a bigger number of. So we'll continue to see inventory grow because demand continues to grow. That three- to four-week target, how it is something we've highlighted in the past. Again, that's a decision that wholesalers and Specialty Pharmas will be making.

是的。所以我要說的是——隨著我們繼續看到季度與季度的兩位數增長，庫存單位數量顯然會增加，因為要覆蓋手頭上的三到四個星期，你需要更多的庫存單位數量。因此，由於需求持續成長，我們將繼續看到庫存成長。我們過去曾強調三到四周的目標。同樣，這是批發商和專業製藥公司將做出的決定。

Thank you. And that will conclude the Q&A portion of today's call.

謝謝。今天電話會議的問答部分就到此結束。

With that, I will turn it back to Barry for closing remarks.

接下來，我將把它轉回給巴里，讓他發表結束語。

Hey, thanks, Justin, and thanks again for all the questions and everyone for joining us this afternoon to review our results for the third quarter of 2024. I know I said on the call, but I do want to take a moment to thank Kimi for her remarkable service to the company. Kimi's been instrumental in originating our exceptional culture, balancing top and bottom line, and really driving a greediness and fortitude that's part of the company now, really helping us to think about short-, medium-, and long-term value. So we wish Kimi the best and look forward to hearing about all her travels and adventures with [Polly].

嘿，謝謝賈斯汀，再次感謝所有的問題和大家今天下午加入我們回顧我們 2024 年第三季的業績。我知道我在電話中說過，但我確實想花點時間感謝 Kimi 為公司提供的卓越服務。Kimi 在創立我們卓越的文化、平衡營收和利潤方面發揮了重要作用，並真正推動了公司現在的貪婪和堅韌，真正幫助我們思考短期、中期和長期價值。所以我們祝 Kimi 一切順利，並期待聽到她與她一起的所有旅行和冒險[波利]。

In closing, we're encouraged by the strength of ZURZUVAE's launch momentum as a treatment for women with PPD and deliberate in our plan to sustain growth through our commercialization efforts. We're also looking forward to sharing top-line data from the dementia study of dalzanemdor and people with cognitive impairment associated with Huntington's disease anticipated before the end of the year. And finally, we're making strategic decisions intended to build for short-, medium-, and long-term value creation.

最後，我們對 ZURZUVAE 作為治療產後憂鬱症女性的治療藥物的強勁推出勢頭感到鼓舞，並認真制定了透過商業化努力維持成長的計劃。我們也期待在今年年底前分享達札南多癡呆症研究的主要數據以及與亨丁頓舞蹈症相關的認知障礙患者的數據。最後，我們正在製定旨在創造短期、中期和長期價值的策略決策。

Thanks again, everyone, and have a great day.

再次感謝大家，祝您有美好的一天。

Thank you. That does conclude today's conference. We do thank you for your participation. Have an excellent day.

謝謝。今天的會議到此結束。我們非常感謝您的參與。祝你有美好的一天。