Minerva Neurosciences Inc (NERV) 2023 Q1 法說會逐字稿

Welcome to the Minerva Neurosciences First Quarter 2023 Conference Call. (Operator Instructions) This call is being webcast live on the Investors section of Minerva's website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded. I would now like to turn the call over to Geoff Race, President of Minerva Neurosciences. Please go ahead.

歡迎參加 Minerva Neurosciences 2023 年第一季電話會議。 （操作員指示）本次電話會議將在 Minerva 網站 ir.minervaneurosciences.com 的投資者部分進行網路直播。提醒一下，今天的通話正在錄音。現在我想將電話轉給 Minerva Neurosciences 總裁 Geoff Race。請繼續。

Good morning. A press release with the company's first quarter 2023 financial results and business highlights became available at 7:30 a.m. Eastern Time today and can be found on the Investors section of our website. Our quarterly report on Form 10-Q was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov.

早安.一份包含公司 2023 年第一季財務業績和業務亮點的新聞稿於今天東部時間上午 7:30 發布，可在我們網站的「投資者」部分找到。我們的 10-Q 表季度報告也於今天早上以電子形式提交給了美國證券交易委員會，可在美國證券交易委員會網站 www.sec.gov 上查閱。

Joining me on the call today from Minerva are Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer; and Mr. Fred Ahlholm, Senior Vice President and Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A.

今天與我一起參加 Minerva 電話會議的還有執行董事長兼執行長 Remy Luthringer 博士；以及資深副總裁兼財務長 Fred Ahlholm 先生。在我們準備好的發言之後，我們將開始問答環節。

Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption Risk Factors in our filings with the SEC including our quarterly report on Form 10-Q for the quarter ended 31st of March 2023 filed with the SEC earlier today.

在我們開始之前，我想提醒您，今天的討論將包括有關公司未來預期、計劃和前景的陳述，這些陳述構成《1995 年私人證券訴訟改革法》安全港條款規定的前瞻性陳述。這些前瞻性陳述是基於我們目前的預期，由於各種因素，可能與實際結果有重大差異，這些因素在我們提交給美國證券交易委員會的文件中「風險因素」標題下有更詳細的說明，包括我們今天稍早向美國證券交易委員會提交的截至 2023 年 3 月 31 日季度的 10-Q 表季度報告。

Any forward-looking statements made on this call speak only as of today's date, Monday, the 15th of May 2023. And the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law.

本次電話會議上所做的任何前瞻性陳述均僅截至今天（2023 年 5 月 15 日星期一）有效。

I would now like to turn the call over to Remy Luthringer.

現在我想將電話轉給雷米路德林格 (Remy Luthringer)。

Thank you, Geoff, and good morning, everyone. Thank you for joining us today. I would like to begin with the great news about our roluperidone program. We received confirmation on the 27th of April from the FDA that our NDA was filed and on the 8th of May, we received confirmation that the review will proceed on a standard review timeline with a PDUFA goal date of February 26, 2024.

謝謝你，傑夫，大家早安。感謝您今天加入我們。首先我想跟大家介紹一下我們的羅哌酮計畫的好消息。我們於 4 月 27 日收到 FDA 的確認，確認我們的 NDA 已提交；5 月 8 日，我們收到確認，審查將按照標準審查時間表進行，PDUFA 目標日期為 2024 年 2 月 26 日。

At this time, the FDA stated that it is not planning to hold an advisory committee. The FDA also noted that they had identified as potential review issues, those issues already cited in the FDA's Refusal to File letter and communicated in the Type C meeting in March 2022, which I will discuss in a moment. Roluperidone has a novel mechanism of action in a new indication, and this has not been a straightforward filing process. So let me provide you with some additional insights in our recent interactions with the agency.

目前，FDA 表示沒有計劃召開諮詢委員會。 FDA 也指出，他們已將這些問題確定為潛在的審查問題，這些問題已在 FDA 的拒絕提交信中提及，並在 2022 年 3 月的 C 類會議上進行了溝通，我稍後將討論這些問題。羅哌酮在新適應症中具有新穎的作用機制，而這並不是一個簡單的申請過程。因此，讓我為您提供一些我們最近與該機構互動的額外見解。

Negative symptoms of schizophrenia are notoriously difficult to treat and as Dr. Harvey commented following the filing of our NDA, an approved treatment for negative symptoms could revolutionize the treatment of schizophrenia. This is underscored by the lack of any approved drugs in the U.S. to treat these symptoms. And to the best of my knowledge, there are no drugs currently in development that have a specific and direct benefit on negative symptoms of schizophrenia and very importantly, that translate into a functional improvement in patients.

眾所周知，精神分裂症的陰性症狀很難治療，正如哈維博士在我們提交保密申請後所評論的那樣，一種獲批的針對陰性症狀的治療方法可能會徹底改變精神分裂症的治療方法。美國缺乏任何核准的藥物來治療這些症狀，這更凸顯了這一點。據我所知，目前正在研發的藥物中還沒有任何一種能夠對精神分裂症的負面症狀有明確而直接的益處，而且非常重要的是，能夠轉化為患者的功能改善。

While other drugs in development may reduce negative symptoms as a consequence of improving positive symptoms and those related to the side effect of antipsychotics, none have been shown to be effective directly and specifically on disease-related negative symptoms. Furthermore, our 2 late-stage studies have shown that improvement in the measures of negative symptoms translates into an improvement of daily functioning. Again, to the best of my knowledge, roluperidone is the only drug that has shown both improvement of disease-related negative symptoms and as a consequence, daily functional ameliorations in patients.

雖然其他正在研發的藥物可能會透過改善陽性症狀和與抗精神病藥物副作用相關的症狀來減少陰性症狀，但沒有一種藥物被證明對疾病相關的陰性症狀具有直接和特異性的有效作用。此外，我們的兩項後期研究表明，陰性症狀指標的改善意味著日常功能的改善。再次，據我所知，羅哌酮是唯一一種既能改善疾病相關的負面症狀，又能改善患者的日常功能的藥物。

Last but not least, it is well documented in the scientific literature that antipsychotic drugs that block dopaminergic pathways in the brain may cause drug-related worsening of negative symptoms beyond the negative symptoms that are disease related. Roluperidone, I believe, in monotherapy is intended to treat specifically those negative symptoms that are disease-related in a well-identified patient subpopulation which isn't prone to relapse as has been demonstrated in both of our late-stage clinical trials.

最後但並非最不重要的一點是，科學文獻中有充分的證據表明，阻斷大腦多巴胺通路的抗精神病藥物可能會導致與藥物有關的負面症狀惡化，超出與疾病相關的負面症狀。我認為，羅哌酮單一療法旨在專門治療與疾病相關的負面症狀，而這些症狀在明確確定的患者亞群中不易復發，這在我們的兩項後期臨床試驗中都得到了證實。

While we intend for roluperidone to be prescribed as a monotherapy, one of the issues FDA raised is its potential use by patients on antipsychotics. When we began roluperidone's clinical development, we deliberately chose to position roluperidone as a monotherapy. We chose this approach based on both KOL feedback and my personal experience in clinical practice that highlighted an important, underserved population; the substantial number of patients diagnosed with schizophrenia who do not need continuous antipsychotic drug therapy to manage their positive symptoms, but whose negative symptoms render them incapable of living normal lives.

雖然我們打算將羅哌酮作為單一療法來開處方，但 FDA 提出的問題之一是服用抗精神病藥物的患者可能會使用它。當我們開始羅哌酮的臨床開發時，我們特意選擇將羅哌酮定位為單一療法。我們根據 KOL 回饋和我個人的臨床實務經驗選擇了這種方法，強調了重要的、服務不足的族群；大量被診斷為精神分裂症的患者不需要持續使用抗精神病藥物治療來控制他們的陽性症狀，但他們的陰性症狀使他們無法過正常的生活。

As previously mentioned, these are the patients that we recruited and studied in our clinical trials. We estimate that around 60% to 70% of patients diagnosed with schizophrenia suffer from moderate to severe negative symptoms. Of those, a significant number do not require antipsychotics to control and stabilize the positive symptoms. Supported by data from our Phase IIb and Phase III studies that included this well-defined group of patients, we submitted our NDA, seeking the approval of 64-milligram of roluperidone. We believe that these trials were adequate and well controlled for the proposals of submitting an NDA. The overall data set included results from 2 doses, 32 milligrams and 64 milligrams. Each study was placebo-controlled and included a 12-week double-blind period comparing monotherapy roluperidone to placebo.

如前所述，這些是我們在臨床試驗中招募和研究的患者。我們估計大約 60% 至 70% 的精神分裂症患者患有中度至重度的陰性症狀。其中相當一部分患者不需要使用抗精神病藥物來控制和穩定陽性症狀。在包括這一明確定義的患者群體的 IIb 期和 III 期研究數據的支持下，我們提交了 NDA，尋求 64 毫克羅哌酮的批准。我們相信，這些試驗對於提交 NDA 的提議來說是充分且控制良好的。總體資料集包括2劑、32毫克和64毫克的結果。每項研究都採用安慰劑對照，包括 12 週的雙盲期，比較單一療法羅哌酮與安慰劑。

Also included were the data from the 6 months open-label extension phase of the Phase IIb study and data from the 9 months open label extension of the Phase III study. The Phase IIb study was positive and met the primary endpoint as well as most of the secondary and exploratory endpoints for both doses.

其中還包括 IIb 期研究的 6 個月開放標籤擴展階段的數據和 III 期研究的 9 個月開放標籤擴展階段的數據。 IIb 期研究取得了積極成果，達到了兩種劑量的主要終點以及大多數次要終點和探索性終點。

The Phase III study achieved a nominal p-value of 0.044 on the primary endpoint for 64-milligram but did not reach statistical significance for 32 milligram. The p-values are only nominal p-values due to the fact that the type 1 error correction used in the trial requires that either both doses must show a p-value below 0.05 to declare a positive study or a single dose must show a p-value below 0.025 to declare a positive finding in that dose arm only, and this was not achieved. So a key secondary endpoint measuring daily functioning PSP showed nominally statistically significant superiority of roluperidone compared to placebo at both doses.

第三階段研究在 64 毫克的主要終點上實現了 0.044 的名義 p 值，但對於 32 毫克沒有達到統計學意義。 p 值只是名義 p 值，因為試驗中使用的 1 型誤差校正要求兩種劑量的 p 值必須低於 0.05 才能宣布研究結果為陽性，或者單劑量的 p 值必須低於 0.025 才能宣布僅在該劑量組中發現陽性，而這並未實現。因此，測量日常功能 PSP 的一個關鍵次要終點顯示，與兩種劑量的安慰劑相比，羅哌酮具有名義上的統計優勢。

One final point regarding our studies that is worth mentioning, which FDA has raised as a potential issue, and which we have discussed extensively with the FDA is the countries in which our studies were conducted. We enrolled the Phase IIb study exclusively in Europe while the Phase III study included patients from both the U.S. and Europe. Schizophrenia as a disease does not vary from country to country. Patients demonstrate the same symptoms and are treated with the same drugs irrespective of where they live.

關於我們的研究，最後一點值得一提，FDA 已提出這一點作為一個潛在問題，我們已經與 FDA 進行了廣泛的討論，那就是我們進行研究的國家。 我們專門在歐洲進行了 IIb 期研究，而 III 期研究則包括了來自美國和歐洲的患者。精神分裂症作為一種疾病，在不同國家並不存在差異。無論居住在哪裡，患者都會表現出相同的症狀並接受相同的藥物治療。

The U.S. patients and European patients in our Phase III study had virtually identical baseline symptom scores and had comparable responses to roluperidone as measured by both the primary and the key secondary end points throughout the study. I would like to personally thank the FDA for the opportunity to have our NDA review, and we look forward to continuing to work with the agency to address their questions.

我們 III 期研究中的美國患者和歐洲患者俱有幾乎相同的基線症狀評分，並且在整個研究過程中對羅哌酮的反應具有可比性，這透過主要終點和關鍵次要終點來衡量。我個人要感謝 FDA 給予我們 NDA 審查的機會，我們期待繼續與該機構合作解決他們的問題。

It's critical for many reasons we have discussed here today that we find an effective and safe treatment for patients with negative symptoms of schizophrenia. Thank you.

由於我們今天在此討論的許多原因，找到一種對患有精神分裂症陰性症狀的患者有效且安全的治療方法至關重要。謝謝。

I will continue to update all of Minerva's stakeholders of our progress in the coming months. I will now turn it over to Fred for the financial update.

我將在接下來的幾個月繼續向 Minerva 的所有利害關係人通報我們的進展。現在我將把財務更新轉交給弗雷德。

Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the first quarter ended March 31, 2023. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed with the SEC earlier today. Cash, cash equivalents and restricted cash as of March 31, 2023 were approximately $36.1 million as compared to $36.2 million as of December 31, 2022.

謝謝你，雷米。今天早些時候，我們發布了一份新聞稿，總結了截至 2023 年 3 月 31 日第一季度的經營業績。截至 2023 年 3 月 31 日的現金、現金等價物和受限現金約為 3,610 萬美元，而截至 2022 年 12 月 31 日為 3,620 萬美元。

In January 2023, we received a refund from the FDA of the $3.1 million filing fee for our NDA for roluperidone. This refund was made in accordance with the Federal Food, Drug and Cosmetic Act which allows for a fee waiver for a small business, submitting its first human drug application. We expect the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months based on our current operating plan. The assumptions upon which this estimate are based are routinely evaluated and may be subject to change.

2023 年 1 月，我們收到了 FDA 退還的 310 萬美元羅哌酮 NDA 申請費。此次退款是根據《聯邦食品、藥品和化妝品法案》進行的，該法案允許免除小型企業提交首次人類藥物申請的費用。根據我們目前的營運計劃，我們預計公司現有的現金和現金等價物將足以滿足至少未來 12 個月的預期資本需求。此估計所依據的假設會定期進行評估，且可能會有所變動。

For the 3 months ended March 31, 2023 and 2022, research and development expense was $2.7 million and $5 million, respectively, a decrease of $2.3 million. The decrease in R&D expense was primarily due to lower noncash stock compensation costs and lower consultant fees related to our NDA, which was submitted in the third quarter of 2022. For the 3 months ended March 31, 2023 and 2022, noncash stock compensation costs included in R&D expense was $0.2 million and $0.5 million, respectively.

截至 2023 年 3 月 31 日及 2022 年 3 月 31 日的 3 個月，研發費用分別為 270 萬美元及 500 萬美元，減少 230 萬美元。研發費用的減少主要由於非現金股票薪酬成本降低以及與我們於 2022 年第三季度提交的 NDA 相關的顧問費用降低。

For the 3 months ended March 31, 2023, and 2022, general and administrative expense was $2.7 million and $3 million, respectively, a decrease of $0.3 million. The decrease in G&A expense was primarily due to noncash stock compensation. For the 3 months ended March 31, 2023 and 2022, noncash stock compensation costs included within G&A expense was $0.2 million and $0.6 million, respectively.

截至 2023 年 3 月 31 日及 2022 年 3 月 31 日的 3 個月，一般及行政費用分別為 270 萬美元及 300 萬美元，減少了 30 萬美元。一般及行政費用的減少主要由於非現金股票補償。截至 2023 年 3 月 31 日及 2022 年 3 月 31 日的 3 個月，G&A 費用中包含的非現金股票薪酬成本分別為 0.2 百萬美元及 0.6 百萬美元。

For the 3 months ended March 31, 2023 and 2022. We recognized noncash interest expense of $2 million and $1.8 million, respectively, an increase of $0.2 million. The increase was primarily due to an increase in the carrying value of the liability related to the sale of future royalties for seltorexant to Royalty Pharma for which upfront milestone payments are being amortized under the interest method over the estimated life of the agreement.

截至 2023 年 3 月 31 日和 2022 年 3 月 31 日的 3 個月。成長的主要原因是與向 Royalty Pharma 出售 seltorexant 未來特許權使用費相關的負債帳面價值增加，其中預付里程碑付款正在協議預計有效期內按照利息法攤銷。

Net loss was approximately $7 million for the first quarter of 2023 or a net loss per share of $1.31 basic and diluted, as compared to net loss of approximately $9.8 million or a net loss per share of $1.83 basic and diluted for the first quarter of 2022.

2023 年第一季的淨虧損約為 700 萬美元，或每股基本和攤薄淨虧損 1.31 美元，而 2022 年第一季的淨虧損約為 980 萬美元，或每股基本和攤薄淨虧損 1.83 美元。

Now I'd like to turn the call over to the operator for any questions. Operator?

現在我想將電話轉給接線員以便回答您的​​任何問題。操作員？

(Operator Instructions) Our first question comes from Andrew Tsai with Jefferies.

（操作員指示）我們的第一個問題來自 Jefferies 的 Andrew Tsai。

Thanks all of you for the update and congratulations on that update. So the first question is, it's clearly an interesting turn of events. So naturally, my question is, what do you think exactly drove the FDA to grant this appeal in favor of you guys? Is there something new -- someone new at the FDA reviewing your application? Or did the agency receive some more information from you? What exactly happened?

感謝大家的更新，並祝賀這次更新。所以第一個問題是，這顯然是一個有趣的轉折。因此，我的問題是，您認為究竟是什麼促使 FDA 批准您們的上訴？有什麼新情況嗎？或者該機構從你那裡獲得了更多資訊？究竟發生了什麼事？

Andrew, Remy speaking. So I think what happens is that when we went for this formal dispute resolution request, as you know, you have to provide with an additional briefing book. And you have to detail why you think that your NDA is having all the information needed for a review, yes.

安德魯，我是雷米。因此，我認為，當我們提出正式的爭議解決請求時，如你所知，你必須提供額外的簡報。是的，你必須詳細說明為什麼你認為你的保密協議包含了審查所需的所有資訊。

And I think because we had the chance to have a face-to-face meeting, and to have the attention of the people from the FDA attending the meeting, I think they came to the same conclusion as we are coming, which is that this, how to say, data set we have in our NDA, it needs really an in-depth review, yes.

而且我認為，因為我們有機會進行面對面的會談，並引起與會 FDA 人員的注意，所以我認為他們得出了與我們相同的結論，也就是說，我們在 NDA 中擁有的這個數據集確實需要深入審查，是的。

And as you know, this is only possible when the FDA starts to really look to the data. So long story short, no new data have been added. It was just a matter of re-explaining what is in the NDA and to have the attention from the person from the FDA.

如您所知，只有當 FDA 開始真正關注數據時才有可能。長話短說，沒有增加新數據。這只是重新解釋 NDA 中的內容並引起 FDA 人員注意的問題。

Very clear and I think in your prepared remarks, maybe in your Day-74 letter, it sounded like the FDA told you they did not plan to host an AdCom. Does this development surprise you in any way?

非常清楚，我認為在您準備好的評論中，也許在您的第 74 天的信中，聽起來 FDA 告訴您他們不打算主辦 AdCom。這種發展會令你感到驚訝嗎？

It's a good question. But I mean, what they mentioned is at this stage of the review. So obviously, this can evolve, yes. But is it surprising us? I don't think so. I think we really have to now to start the dialogue with the FDA or to continue the dialogue because I think the dialogue is now really engaged and provide all the answers as the FDA might have.

這是個好問題。但我的意思是，他們提到的是審查的這個階段。顯然，這是可以發展的。但這讓我們感到驚訝嗎？我不這麼認為。我認為我們現在確實必須開始與 FDA 對話或繼續對話，因為我認為對話現在確實很深入，並且提供了 FDA 可能擁有的所有答案。

And hopefully, after 10 months of review, I mean, we will get the drug approved. And again, if I mean, I think the FDA decides that -- I mean, it needs an outcome, they will probably tell us later during the process of review, but no surprise. Just we are focused on providing all the necessary information to the FDA during the course of review.

希望經過 10 個月的審查後，該藥物能夠獲得批准。再說一次，如果我的意思是，我認為 FDA 決定——我的意思是，它需要一個結果，他們可能會在審查過程中告訴我們，但這並不奇怪。我們只是專注於在審查過程中向 FDA 提供所有必要的資訊。

Great. And then very last one is maybe for Fred. How are you thinking about a potential launch in 2024? What is the company's strategy? Would you market roluperidone by yourselves? Or would you seek a partner? And do you think you would start hiring sales reps in this year? Or would you rather wait until the actual approval decision later in 2024?

偉大的。最後一個也許是給弗雷德的。您如何考慮在 2024 年推出產品？公司的策略是什麼？你們會自己推銷羅哌酮嗎？或者你會尋找一位合作夥伴嗎？您認為今年會開始招募銷售代表嗎？或者您寧願等到 2024 年晚些時候做出實際批准決定？

Thank you. Good question. We think about how this is going to evolve over time and certainly, something of this size would require most likely some assistance. So something that we consider as a partner, a type of partner that makes sense for us but one step at a time. So while we look to see what our needs would be in order to be able to launch sooner than later, we're still evaluating that at this time.

謝謝。好問題。我們思考隨著時間的推移這件事將如何發展，當然，這種規模的事情很可能需要一些幫助。因此，我們視某種東西為合作夥伴，這種類型的合作夥伴對我們來說是有意義的，但要一步一腳印。因此，當我們考慮需要什麼以便能夠盡快推出時，我們目前仍在評估這一點。

We have a question from Douglas Tsao with H.C. Wainwright.

我們收到了來自 H.C. 的 Douglas Tsao 的一個問題。溫賴特。

Can you remind us, I believe, in some of the interactions you've had with the FDA leading into the NDA filing. They had identified some other issues besides the conduct of the Phase II, III study. Can you remind us, have those all been resolved or were some of those identified as issues that the agency needed to consider during the review process?

我認為，您能否回憶一下您在提交 NDA 申請之前與 FDA 進行過的一些互動？除了進行第二階段、第三階段研究之外，他們還發現了一些其他問題。您能否提醒我們，這些問題都已解決嗎，或者其中一些是否被確定為該機構在審查過程中需要考慮的問題？

No. So, good question. But -- so what we have done, I mean, during this meeting we had with the FDA, we really addressed in our presentation, all the issues which have been raised by the FDA. And I think the consequence is that they filed our NDA. So probably, we addressed most of the topics which were raised.

不，所以，這是個好問題。但是——所以我們所做的是，我的意思是，在我們與 FDA 的這次會議上，我們確實在我們的報告中解決了 FDA 提出的所有問題。我認為後果是他們向我們提交了保密協議。因此很可能我們已經解決了所提出的大多數問題。

But as you know, I mean, now we are at a review of the NDA and now we are going to the in-depth review of the different parts of the NDA. So now we will have, as I said before, back and forth in terms of questions. I am very confident that we will be able to address the questions they might have or a more in-depth review of some of the topics they already raised. But I think it's fair to say that we were probably able to show at minimum to the FDA that it is important to review this NDA and to go into the details of the different topics assuming. But no new topics, just, I think, a re-explanation, a reassessment of the different topics raised and this led to the filing.

但正如你所知，我們現在正在審查保密協議，並且我們將對保密協議的不同部分進行深入審查。所以現在正如我之前所說的，我們會反覆討論問題。我非常有信心我們能夠解決他們可能存在的問題，或更深入地審查他們已經提出的一些主題。但我認為公平地說，我們至少能夠向 FDA 表明，審查這份 NDA 以及詳細探討不同主題的重要性。但是沒有新的主題，我認為只是重新解釋、重新評估所提出的不同主題，並因此提交了文件。

Okay. Great. And then can you just remind us for seltorexant, what remaining economics you may be entitled to or might be eligible to receive?

好的。偉大的。然後，您能否提醒我們，對於 seltorexant，您可能有權獲得或有資格獲得哪些剩餘經濟利益？

I think this is for Geoff.

我認為這是給傑夫的。

Yes. Thanks for the question, Doug. So we have approximately $95 million left in terms of the milestones in the agreement that we signed with Royalty Pharma. There's a $10 million milestone, which is dependent on the Phase III clinical study. And then there's approximately $60 million related to regulatory approval in various different geographies.

是的。謝謝你的提問，道格。因此，就我們與 Royalty Pharma 簽署的協議中的里程碑而言，我們還剩下約 9500 萬美元。這是一個 1000 萬美元的里程碑，取決於第三階段臨床研究。另外還有約 6000 萬美元與不同地區的監管批准有關。

okay. And then the rest would be commercial -- related to commercial?

好的。其餘的都是商業的──與商業相關的嗎？

That's correct.

沒錯。

Thank you. And I'm showing no further questions. I'd like to turn the call back to Remy Luthringer for closing remarks.

謝謝。我沒有其他問題。我想請雷米路德林格 (Remy Luthringer) 作最後發言。

Yes. Thank you so much. Thank you all for being with us today. And so I think it is a very, very important event which happens as the FDA filed our NDA. Keep in mind that this is the first drug seeking to improve negative symptoms in patients suffering from schizophrenia, which has been filed. So really, I think this is raising a lot of hope for patients and families in need of better treatment because there is no approved treatment for negative symptoms currently approved in the U.S.

是的。太感謝了。感謝大家今天的到來。所以我認為 FDA 提交我們的 NDA 是一件非常非常重要的事情。請記住，這是第一種旨在改善精神分裂症患者負面症狀的藥物，已經提交申請。所以，我認為這確實為需要更好治療的患者和家庭帶來了許多希望，因為目前美國尚未批准任何針對負面症狀的治療方法。

I wanted also to thank again for the time and the listening from the FDA during the meeting we had with them recently, which led to the filing of our NDA. And I'm really looking forward to the exchange with psychotic division in order to really move forward and hopefully go to an approval of roluperidone.

我還要再次感謝 FDA 在我們最近與他們的會談中付出的時間和傾聽，這促使我們提交了 NDA。我非常期待與精神科部門的交流，以便真正取得進展，並希望獲得羅哌酮的批准。

Thank you again, and we will keep you updated when we are moving along and each time news are coming to us. Thank you so much, and have a good day.

再次感謝您，我們隨時向您通報我們的進展和最新動態。非常感謝，祝您有美好的一天。

This concludes today's conference call. Thank you for participating. 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。