Calliditas Therapeutics AB (CALT) 2023 Q3 法說會逐字稿

Thank you and welcome to this Q3 report. I am joined here today by Richard Philipson, our Chief Medical Officer; Fredrik Johansson, our Chief Financial Officer; and Andrew Udell, President of North America.

謝謝並歡迎閱讀第三季報告。今天我們的首席醫療官理查德·菲利普森 (Richard Philipson) 也加入了我的行列。 Fredrik Johansson，我們的財務長；以及北美區總裁 Andrew Udell。

I would like to draw your attention to the disclaimer page which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. And I refer you to public filings including those containing risk factors.

我想提請您注意免責聲明頁面，其中包含 1995 年《私人證券訴訟改革法案》修訂版含義內的前瞻性陳述。我建議您參閱公開文件，包括包含風險因素的文件。

So looking a little bit at the Q3 highlights. So during the quarter, we filed for full approval of TARPEYO with the FDA based on our full Phase-3 data, and also support our partner STADA in filing for standard marketing authorization with EMA.

那我們來看看第三季的亮點。因此，在本季度，我們根據完整的 3 期數據向 FDA 申請了 TARPEYO 的全面批准，並支持我們的合作夥伴 STADA 向 EMA 申請標準行銷授權。

The FDA granted us priority review in August, and our target PDUFA date is December 20. We also saw the publication in The Lancet of our successful Phase-3 results, which was very well received by the nephrology community. And as we subsequently attended the IIgANN conference in late September in Tokyo, we saw a lot of enthusiasm for the data, as well as for the supporting five posters and three oral presentations which we shared with the audience there. Richard will give you a brief overview of some selected abstracts later in this call.

FDA 在 8 月給予我們優先審評，我們的目標 PDUFA 日期是 12 月 20 日。我們也看到《柳葉刀》上發表了我們成功的 3 期結果，受到腎臟病學界的好評。當我們隨後參加 9 月底在東京舉行的 IIgANN 會議時，我們看到了人們對數據以及我們與觀眾分享的五張支持性海報和三場口頭演示的熱情。理查德將在本次電話會議稍後向您簡要概述一些選定的摘要。

On the commercial side, as expected, we saw some summer-related seasonality effects in Q3. With TARPEYO revenues coming in at $26.3 million or SEK284 million based on 367 new enrollments and 197 new prescribers in the quarter. As expected, we're also seeing some very robust growth in enrollments reflected early in Q4. The combination of the strong Phase-3 data, the RaDaR publication, and other events in the GN space, we believe are all combining to generate a very favorable momentum which we also had an opportunity to experience at Kidney Week where also, we had an opportunity to present additional posters and make oral presentations.

在商業方面，正如預期的那樣，我們在第三季度看到了一些與夏季相關的季節性影響。根據本季 367 名新註冊患者和 197 名新處方醫生計算，TARPEYO 收入為 2,630 萬美元，即 2.84 億瑞典克朗。正如預期的那樣，我們也看到第四季初的入學人數出現了非常強勁的成長。我們相信，強大的第 3 階段數據、RaDaR 出版物以及 GN 領域的其他事件的結合將產生非常有利的勢頭，我們也有機會在腎臟週上體驗到這一勢頭，我們也有過有機會展示更多海報並進行口頭演講。

In terms of some post-period events and pipeline updates. With regards to our pipeline during Q3, setanaxib was granted ODD in Alport syndrome in both Europe and the US. Whilst with regards to events post Q3, we saw the filing with the MHRA with STADA, and an approval in Macau for Everest Medicines.

就一些期後事件和管道更新而言。關於我們第三季的產品線，setanaxib 在歐洲和美國都獲得了治療 Alport 症候群的 ODD ODD。關於第三季後的事件，我們看到了向 MHRA 和 STADA 提交的文件，以及 Everest Medicines 在澳門的批准。

However, the most impactful important event was the recent ASN meeting, the Kidney Week in Philadelphia. We were able to meet with a very large number of practicing nephrologists from across the US. We also have got to listen to a multitude of relevant presentations and poster presentations, and we're able to gain insight into the early and continuing formation of clinical practice involving GN patients and the experiences of clinicians and patients with TARPEYO.

然而，最具影響力的重要活動是最近舉行的 ASN 會議，即費城腎臟週。我們能夠會見來自美國各地的大量執業腎臟病專家。我們還必須聽取大量相關演示和海報演示，並且能夠深入了解涉及 GN 患者的臨床實踐的早期和持續形成以及臨床醫生和 TARPEYO 患者的經驗。

It was a very positive experience with a lot of great insights and positive feedback on the use of TARPEYO in the real-world setting. There is a real sense of momentum building for the treatment of IgAN patients. And we are excited and energized coming out of an ASN and look forward to continue building on our category leadership position.

這是一次非常積極的體驗，對於在現實環境中使用 TARPEYO 獲得了很多深刻的見解和積極的回饋。 IgAN 患者的治療確實勢頭強勁。我們對於獲得 ASN 感到興奮和充滿活力，並期待繼續鞏固我們的類別領導地位。

With that, I'm going to hand over to our Chief Medical Officer, Richard Philipson, who will take you through some selected information regarding our posters and abstracts.

接下來，我將把工作交給我們的首席醫療官理查德·菲利普森，他將帶您瀏覽一些有關我們的海報和摘要的精選信息。

Thanks very much, Renée. Next slide. So we're delighted to had a strong presence at two recent global nephrology conferences, the 17th International Symposium on IgA Nephropathy in Tokyo and the American Society of Nephrology Annual Meeting in Philadelphia. Over the two conferences, the total of 12 posters and four oral presentations were given. In addition to educational satellite symposia, demonstrating our commitment to IgA nephropathy and rare kidney diseases.

非常感謝，蕾妮。下一張投影片。因此，我們很高興能夠在最近的兩場全球腎臟病學會議上亮相，即在東京舉行的第 17 屆 IgA 腎病國際研討會和在費城舉行的美國腎臟病學會年會。兩次會議共發布了12張牆報和4次口頭報告。除了教育衛星研討會之外，還展示了我們對 IgA 腎臟病和罕見腎臟病的承諾。

I'd like to highlight some of the data and analyses that have been presented at these meetings. Professor Richard Lafayette presented analyses of the NeflgArd Phase-3 trial at ASN last week. The focus of the presentation was the time to 30% reduction in eGFR or kidney failure which was a secondary endpoints of the trial. The time to this composite endpoint was significantly delayed, with a 55% reduction in the risk of achieving this event in patients treated with Nefecon compared to placebo.

我想重點介紹這些會議上提出的一些數據和分析。 Richard Lafayette 教授上週在 ASN 上介紹了 NeflgArd 第三期試驗的分析。演示的重點是 eGFR 降低 30% 或腎衰竭的時間，這是該試驗的次要終點。達到這一複合終點的時間顯著延遲，與安慰劑相比，接受 Nefecon 治療的患者實現這一事件的風險降低了 55%。

It is particularly noteworthy that this outcome was consistent irrespective of baseline UPCR. And overall, it's supportive of the long-term treatment benefits of Nefecon. We also presented at ASN a model's analysis of clinical outcomes of patients in the Nefecon trial compared with the matched registry cohort receiving supportive care only.

特別值得注意的是，無論 UPCR 基線如何，這一結果都是一致的。總體而言，它支持 Nefecon 的長期治療效果。我們還在 ASN 上展示了 Nefecon 試驗中患者的臨床結果與僅接受支持性護理的匹配註冊隊列進行比較的模型分析。

We use the metric of two-year eGFR total slope outcome to calculate a hazard ratio for the clinical outcome of kidney failure, eGFR less than 15 mils per minute or sustained doubling of serum creatinine. Using the Inker meta-analysis as reference, this analysis showed a predicted median delay to the clinical outcome of 12.8 years when comparing Nefecon with placebo. Approximately 50% fewer patients were predicted to have a clinical outcome within 10 years, again, when comparing Nefecon with placebo.

我們使用兩年 eGFR 總斜率結果指標來計算腎衰竭、eGFR 低於 15 密耳/分鐘或血清肌酸酐持續加倍的臨床結果的風險比。使用 Inker 薈萃分析作為參考，該分析顯示，當比較 Nefecon 與安慰劑時，預計臨床結果的中位數延遲為 12.8 年。與安慰劑相比，Nefecon 與安慰劑相比，預計 10 年內出現臨床結果的患者數量將減少約 50%。

We also presented biomarker analyses confirming previous findings from the Phase-2B Nefecon trial. As you know, circulating immune complexes containing poorly galactosylated IgA, when deposited in the mesangium of the glomerulus, elicits an inflammatory response and drives the decline in kidney function seen in patients with IgA nephropathy. We have shown in samples taken from 160 patients in the NeflgArd trial that Nefecon significantly reduces levels of circulating immune complexes throughout the treatment period compared to placebo, supporting the disease-modifying effect of the treatment.

我們也提供了生物標記分析，證實了 Nefecon 2B 期試驗的先前結果。如您所知，含有半乳糖基化不良的 IgA 的循環免疫複合物沉積在腎小球系膜中時，會引發發炎反應並導致 IgA 腎病患者的腎功能下降。我們在 NeflgArd 試驗中從 160 名患者身上採集的樣本中發現，與安慰劑相比，Nefecon 在整個治療期間顯著降低了循環免疫複合物的水平，支持了該治療的疾病緩解作用。

In collaboration with Professor Jennifer Dressman of the Goethe University in Frankfurt, we also presented data on the in vitro dissolution profile with Nefecon compared to other budesonide products specifically Entocort, Budenofalk, and Uceris. On the bio-relevant in vitro experimental conditions, we observed that the four formulations had distinct release profiles. When using Nefecon as a reference, we demonstrated that the three other formulations are statistically dissimilar. Taking into account differences in indications, doses, duration of treatments, and dosing conditions in conjunction with the differing dissolution profiles, we conclude that there is no basis to consider the four products to be pharmaceutically or therapeutically interchangeable.

我們與法蘭克福歌德大學的 Jennifer Dressman 教授合作，也提供了 Nefecon 與其他布地奈德產品（特別是 Entocort、Budenofalk 和 Uceris）相比的體外溶離曲線數據。在生物相關的體外實驗條件下，我們觀察到四種製劑具有不同的釋放曲線。當使用 Nefecon 作為參考時，我們證明其他三種配方在統計上是不同的。考慮到適應症、劑量、治療持續時間和給藥條件的差異以及不同的溶出曲線，我們得出的結論是，沒有基礎認為這四種產品在藥物或治療上可以互換。

Finally, I'm very proud that we presented preclinical data supporting the potential clinical efficacy of setanaxib in the rare hereditary kidney disease, Alport syndrome. This work was carried out in collaboration with Professor Rachel Lennon of Manchester University, a recognized global leader in Alport syndrome research and treatment.

最後，我感到非常自豪的是，我們提供了臨床前數據，支持 setanaxib 在罕見的遺傳性腎病 Alport 綜合徵中的潛在臨床療效。這項工作是與曼徹斯特大學的 Rachel Lennon 教授合作進行的，Rachel Lennon 教授是阿爾波特綜合徵研究和治療領域公認的全球領導者。

We used a Col4a3 knockout mouse model of Alport syndrome and show statistically significant effects to setanaxib when given in conjunction with supportive care, renin angiotensin system blockade. We saw changes in biochemical outcomes, and also histological outcomes such as sclerosis and fibrosis. We plan to start a Phase-2 clinical trial in Alport syndrome by the end of this year, and have recently received orphan drug designation in both the US and Europe.

我們使用了 Alport 症候群的 Col4a3 基因敲除小鼠模型，結果顯示，當與支持性治療、腎素血管張力素系統阻斷合併使用時，setanaxib 具有統計上顯著的效果。我們看到了生化結果的變化，以及硬化和纖維化等組織學結果的變化。我們計劃在今年年底前啟動阿爾波特症候群的第二期臨床試驗，並最近在美國和歐洲獲得了孤兒藥資格認定。

I'll now hand over to Andrew Udell.

現在我將把工作交給安德魯·烏德爾 (Andrew Udell)。

Thanks, Richard. Next slide. As anticipated and seen last year, the third quarter was impacted by summer seasonality which is caused by vacation and holiday time for both patients and nephrologists, which reduced the volume of patient visits with a disease like IgA nephropathy.

謝謝，理查。下一張投影片。正如去年所預期和看到的那樣，第三季度受到夏季季節性因素的影響，夏季季節性因素是患者和腎病專家的休假時間造成的，這減少了 IgA 腎病等疾病的患者就診量。

During the quarter, TARPEYO achieved net sales of $26.3 million. We had 367 new enrollments, bringing the 2023 total to approximately 1,200 enrollments. In addition, during this period of accelerated approval, we continue to see new prescribers with almost 200 new prescribers for TARPEYO in Q3. Importantly, we continue to have a very strong conversion rate with 86% of patients enrolled in TARPEYO touchpoints receiving TARPEYO year to date. Next slide, please.

本季度，TARPEYO 實現淨銷售額 2,630 萬美元。我們有 367 名新註冊學生，使 2023 年註冊學生總數達到約 1,200 名。此外，在加速審批期間，我們繼續看到新的處方者，第三季 TARPEYO 新增處方者近 200 名。重要的是，我們仍然保持著非常高的轉換率，今年迄今為止，在 TARPEYO 接觸點登記的患者中有 86% 接受了 TARPEYO。請下一張投影片。

The third quarter contains significant milestones and events for Calliditas. Receiving priority review from the FDA puts us on target for December 20 PDUFA. As we've mentioned, it isn't until FDA full approval and label changes that we can commercially promote new information to the prescribing nephrologists. Until that time nephrologists learn of the data through peer-to-peer interactions, publications, and scientific meetings which were described by Richard.

第三季包含了 Calliditas 的重要里程碑和事件。獲得 FDA 的優先審查使我們預計在 12 月 20 日實現 PDUFA。正如我們所提到的，直到 FDA 完全批准並更改標籤後，我們才能向腎病專家進行商業推廣新資訊。在那之前，腎臟科醫生透過理查德描述的同儕互動、出版物和科學會議來了解這些數據。

As you heard, during Q3, the full results from the NeflgArd study were published in The Lancet and the IIgANN conference took place in Tokyo. I want to reiterate, we have seen during these industry conferences and at advisory boards, the overwhelmingly positive reaction this data has had on nephrologists when introduced to the strong clinical results of TARPEYO. Next slide, please.

正如您所聽到的，第三季度，NeflgArd 研究的完整結果發表在《柳葉刀》上，IIgANN 會議在東京舉行。我想重申，我們在這些行業會議和諮詢委員會中看到，當腎臟病專家介紹 TARPEYO 的強大臨床結果時，這些數據產生了壓倒性的積極反應。請下一張投影片。

We are very excited at the opportunity ahead of us. We're just back from an action-packed ASN where the energy and momentum for IgAN and TARPEYO was palpable. The interactions were productive, insightful, and keep us motivated to serve this patient population with a disease-specific treatment for IgA nephropathy like TARPEYO.

我們對擺在我們面前的機會感到非常興奮。我們剛從充滿活力的 ASN 回來，IgAN 和 TARPEYO 的活力和動力顯而易見。這些互動富有成效、富有洞察力，讓我們有動力為這些患者群體提供 TARPEYO 等針對 IgA 腎病的疾病特異性治療。

During the fourth quarter, as we move towards an anticipated full approval, we are expanding our Calliditas US team in order to support and strengthen our category leadership position. This includes the addition of both internal and external facing team members in medical affairs, marketing, market access, and sales. As we have done since launch during the accelerated approval, we are deliberate in our growth that is directly sized to appropriately support patient and physician demand, increase our reach, and maximize the market potential.

在第四季度，隨著我們朝著預期的全面批准邁進，我們正在擴大 Calliditas 美國團隊，以支持和加強我們的類別領導。這包括在醫療事務、行銷、市場准入和銷售方面增加面向內部和外部的團隊成員。正如我們自推出以來在加速批准期間所做的那樣，我們對我們的成長進行了深思熟慮，直接調整規模，以適當支持患者和醫生的需求，擴大我們的覆蓋範圍，並最大限度地發揮市場潛力。

With that, I'll turn it over to Fredrik Johansson for our financial overview.

接下來，我將把它交給弗雷德里克·約翰遜（Fredrik Johansson），以了解我們的財務概況。

Thank you, Andy, and good afternoon and good morning, everyone. I will now present to you the financial overview for the third quarter of 2023. And as always, all numbers presented to you are in million SEK unless otherwise stated.

謝謝你，安迪，大家下午好，早安。我現在將向您介紹 2023 年第三季的財務概況。與往常一樣，除非另有說明，否則向您提供的所有數字均以百萬瑞典克朗為單位。

To start with, we reported SEK294.6 million in net revenues for the quarter. For the same quarter last year, we reported net revenues of SEK260.1 million. And please note that in the comparison quarter last year, a milestone of SEK135 million from STADA was included.

首先，我們報告本季淨收入為 2.946 億瑞典克朗。去年同一季度，我們公佈的淨收入為 2.601 億瑞典克朗。請注意，在去年的比較季度中，包括了來自 STADA 的 1.35 億瑞典克朗的里程碑。

TARPEYO net product sales for the quarter amounted to SEK283.6 million or $26.3 million, which is a reported increase of 130% compared to the same quarter previous year. For the nine-month period, TARPEYO net product sales amounted to SEK728.5 million or $68.8 million. In addition, we also recorded SEK11 million in revenues in the quarter related to partners, primarily from royalties based on Kinpeygo sales in Europe.

TARPEYO 本季產品淨銷售額達 2.836 億瑞典克朗（2,630 萬美元），據報導與去年同期相比成長了 130%。在這 9 個月期間，TARPEYO 的產品淨銷售額達到 7.285 億瑞典克朗或 6,880 萬美元。此外，本季我們也錄得與合作夥伴相關的 1,100 萬瑞典克朗收入，主要來自基於 Kinpeygo 在歐洲銷售的特許權使用費。

For total operating expenses for the quarter amounted to SEK439.2 million compared to SEK292 million for the same quarter last year. The cost for research and development increased by SEK77 million in the quarter to SEK179.9 million compared with SEK102.9 million for the same quarter previous year. Increase in R&D expenses, reasons primarily from an impairment cost of SEK32 million and the increased clinical activities for the NOX platform, including the ongoing setanaxib trials in head and neck cancer and PBC. And we also see some costs for the preparations for Alport trial.

本季的總營運費用為 4.392 億瑞典克朗，去年同期為 2.92 億瑞典克朗。本季研發成本增加 7,700 萬瑞典克朗，達到 1.799 億瑞典克朗，去年同期為 1.029 億瑞典克朗。研發費用增加，主要是由於 3,200 萬瑞典克朗的減損成本以及 NOX 平台臨床活動的增加，包括正在進行的頭頸癌和 PBC 的 setanaxib 試驗。我們也看到了阿爾波特試驗準備工作的一些費用。

While we change the trial design of the TRANSFORM on PBC during the quarter to a Phase 2B only, with anticipated readout mid next year. A shorter study has the potential to significantly reduce the planned R&D costs in the trial for both '24 and '25, but we had some additional cost in this quarter originating from the change of the study of approximately SEK20 million. We can consider this additional TRANSFORM costs and the impairment cost previously mentioned to be of one-time nature for this quarter.

雖然我們在本季將 PBC 上的 TRANSFORM 試驗設計更改為僅 2B 階段，預計將於明年中期公佈。較短的研究有可能大幅降低 24 年和 25 年試驗中計畫的研發成本，但本季我們因研究的變化而產生了一些額外成本，約為 2,000 萬瑞典克朗。我們可以認為這額外的轉換成本和前面提到的減損成本在本季具有一次性性質。

The cost for sales and marketing increased by SEK54.4 million to SEK170.5 million compared to 116.1 million for the same quarter previous year. Increase is primarily related to the cost for sales and marketing of TARPEYO in the US. And the marketing activities has been intensified, and the salesforce has been increased compared to the corresponding period of the prior year when we had a smaller salesforce. The above led to an operating loss of SEK159.6 million for the quarter compared to SEK36.2 million for the same quarter last year.

銷售和行銷成本增加了 5,440 萬瑞典克朗，達到 1.705 億瑞典克朗，去年同期為 1.161 億瑞典克朗。成長主要與 TARPEYO 在美國的銷售和行銷成本有關。行銷活動力度加大，銷售隊伍較去年同期增加，當時我們的銷售團隊較少。上述因素導致本季營運虧損 1.596 億瑞典克朗，去年同期為 3,620 萬瑞典克朗。

In the third quarter, cash used in operating activities was SEK62.5 million compared to SEK124.7 million for the same quarter previous year. This leaves us with a net decrease in cash in the quarter of SEK72.8 million. And we continue to have a healthy cash position of SEK786.9 million or approximately $73 million at the end of the quarter, which we believe is sufficient to take us to cash flow breakeven.

第三季經營活動使用的現金為 6,250 萬瑞典克朗，去年同期為 1.247 億瑞典克朗。這使得我們本季的現金淨減少 7,280 萬瑞典克朗。截至本季末，我們仍擁有 7.869 億瑞典克朗（約 7,300 萬美元）的健康現金狀況，我們相信這足以使我們實現現金流盈虧平衡。

That was all for me. And now, back to you, Renée.

這就是我的全部。現在，回到你身上，蕾妮。

Thank you, Fredrik. So just to summarize, in terms of some of the key takeaways for this quarter. We are starting to see a much broader impact from the publication of the full Phase-3 in The Lancet. And we've also obviously continued to provide supporting data both for the local mode of action and long-term benefits of treatment with TARPEYO.

謝謝你，弗雷德里克。總結本季的一些關鍵要點。我們開始看到《刺胳針》第三階段全文的發表產生了更廣泛的影響。顯然，我們也持續提供 TARPEYO 治療的局部作用模式和長期益處的支持數據。

We saw continued revenue growth in Q3, coupled with low net cash burn, resulting in a strong cash position. And we confirm our revenue guidance for TARPEYO of $100 million to $120 million for the year of 2023. I also want to reiterate the strong sense of growing momentum. Positive momentum from ASN really focused on this increased awareness based partly of longitudinal data related to the progression of IgAN patients. Other publicated data coming out of the general GN space. And also, just the general sense from nephrology community that there is an increased sense among that there is a need to treat this patient population. So with that, we look forward to Q4, our PDUFA date, and obviously the rest of 2023.

我們看到第三季的營收持續成長，加上淨現金消耗較低，導致現金狀況強勁。我們確認 TARPEYO 2023 年的營收指引為 1 億至 1.2 億美元。我還想重申強烈的成長動能。 ASN 的積極勢頭確實集中於基於與 IgAN 患者進展相關的部分縱向數據的認識的提高。其他已發布的數據來自通用 GN 空間。而且，腎臟病學界普遍認為，越來越多的人認為有必要治療這群患者。因此，我們期待第四季、我們的 PDUFA 日期，當然還有 2023 年剩餘時間。

With that, we're ready to take any questions.

這樣，我們就可以回答任何問題了。

(Operator Instructions) Vamil Divan, Guggenheim Securities.

（操作員指令）Vamil Divan，古根漢證券。

Great. Thanks for taking my questions. So I have a couple just on the commercial side if I could. One is you mentioned that there's been a little bit of a turnover in the sales force. And then, you've also mentioned that you're looking to increase your investment here going forward to drive the commercial uptake.

偉大的。感謝您回答我的問題。所以如果可以的話，我有一些只是在商業方面。一是您提到銷售人員出現了一些流動。然後，您還提到您希望增加在這裡的投資，以推動商業應用。

So I'm wondering if you can just give us a little bit more details on either of those? What drove some of this turnover? And then, where do you see the added investment making an impact? Is it more in the tall meter, the academic centers? Is it more on the community?

所以我想知道您是否能為我們提供有關其中任何一個的更多詳細資訊？是什麼推動了這種營業額？那麼，您認為增加的投資會產生哪些影響？是不是更多的是在高米、學術中心？社區更重要嗎？

And also, I'm also wondering maybe there's some disconnect between the positive feedback you're getting from the advisory boards and all that you're holding in these medical meetings, but maybe, it's not yet translating to the community side. So wondering maybe that in some way tied to what you're looking to do to drive uptake on the community side of things? So thank you.

而且，我還想知道，您從諮詢委員會獲得的正面回饋與您在這些醫療會議中舉行的所有內容之間可能存在一些脫節，但也許它尚未轉化為社區方面。所以想知道這是否在某種程度上與您希望採取的措施來推動社區方面的吸收有關？所以謝謝。

Andy, do you want to start that?

安迪，你想開始嗎？

Sure. So as far as the sales force and our increased investment, I mean, there's typically some turnover in sales force. I think the statistic is roughly about 5% per year, so we had some some turnover in the summer. And I think we also initiated some of that really in areas where we felt we needed a heavier concentration with greater nephrology background.

當然。就銷售團隊和我們增加的投資而言，我的意思是，銷售團隊通常會有一些流動。我認為統計數據每年大約為 5%，所以我們在夏天有一些人員流動。我認為我們也確實在我們認為需要更加集中精力並具有更多腎臟病學背景的領域啟動了其中的一些工作。

As far as the investment and increased investment, we really -- I am not going to go into all the details, but I think we, from a sales force sizing, that's the easiest number that people sit here and listen to an appropriate support. There, were moving to around a 70-person sales force, okay? But I think it's very important to note that we've been very deliberate.

至於投資和增加投資，我們真的 - 我不會詳細介紹所有細節，但我認為，從銷售人員規模來看，這是人們坐在這裡聆聽適當支持的最簡單的數字。在那裡，我們的銷售團隊大約有 70 人，好嗎？但我認為值得注意的是，我們是經過深思熟慮的。

As we've said, this is not this is in areas where we feel there's a appropriate need in access. And we've done -- and we've added a lot of other individuals for support programs, and to reach some of these accounts and larger accounts as well.

正如我們所說，這不是我們認為有適當存取需求的領域。我們已經做到了，我們還添加了許多其他個人來支持計劃，並接觸到其中一些帳戶和更大的帳戶。

And I think you're right as far as and the disconnect between the ad boards and these community. This is the first time where when we interact with people right now, this is the first time that they're learning about the data. So it's an ad board or if it's at these conferences, so they have an -- this is their initial reactions to this and that hasn't translated to, first of all regulatory -- new regulatory indication and approval yet, and to the community. So this will come with time, so it's not a disconnect, it just takes time which is basically, I guess what would be normal. So I think that that hopefully answers your questions.

我認為就廣告板和這些社群之間的脫節而言，你是對的。這是我們第一次與人們互動，這是他們第一次了解數據。因此，這是一個廣告板，或者如果是在這些會議上，那麼他們有一個——這是他們對此的初步反應，這還沒有轉化為，首先是監管——新的監管指示和批准，以及社區。所以這會隨著時間的推移而出現，所以這不是一種脫節，只是需要時間，這基本上是，我想什麼是正常的。所以我認為這有望回答您的問題。

Okay. Thank you very much. I get back into queue. Thanks.

好的。非常感謝。我回到隊列。謝謝。

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

Hi, Renée and Team. Thank you for taking the question. I just had a question on the assumptions for the guidance. It seems like to get to the lower end of the guidance range, we'll need about a 20% quarter-on-quarter growth for the last quarter.

嗨，Renee 和團隊。感謝您提出問題。我只是對指南的假設有疑問。似乎要達到指導範圍的下限，我們需要上一季的季增約 20%。

Can you just discuss your assumptions around that? Is it being driven by the reversal of the seasonal weakness as you as you mentioned, or the reinforcing of the salesforce, or potentially even the full approval later this quarter? Thank you.

您能談談您對此的假設嗎？它是由您提到的季節性疲軟的逆轉，還是銷售隊伍的加強，甚至可能是本季度晚些時候的全面批准推動的？謝謝。

Of course. So I think that it is clearly a combination of a couple of things. Obviously, it is the fact that we are adding some resources. We are -- we have been adding towards the end of this last quarter towards the sales force as well, which does obviously help in terms of reach and frequency in general, but also, I think it is really this. The fact that the data was really published in April, it does take a little while for it to penetrate into the community.

當然。所以我認為這顯然是幾件事的結合。顯然，我們正在增加一些資源。我們在上個季度末也一直在增加銷售隊伍，這顯然對整體覆蓋範圍和頻率有幫助，而且，我認為這確實是這樣。事實上，數據確實是在四月發布的，但它確實需要一段時間才能滲透到社群中。

And I think we are feeling very comfortable about the range that we've provided, and we are seeing as I mentioned, a strong beginning of Q4. So I think it's a combination of all of these things. And importantly, also supported by, I think, real important conversations among nephrologists based on this longitudinal data that was both presented at the ASN. There was a poster by Kaiser Permanente that was discussed a lot. The RaDaR studies discussed a lot of things.

我認為我們對我們提供的產品範圍感到非常滿意，正如我所提到的，我們看到了第四季度的強勁開局。所以我認為這是所有這些事情的結合。重要的是，我認為，腎臟科醫生之間基於這些縱向數據的真正重要的對話也支持了這些對話，這些數據都在 ASN 上提出。 Kaiser Permanente 的一張海報引起了許多討論。 RaDaR 研究討論了很多事情。

Nephrology is really taking a hard look at their IgAN patients and really thinking about treatment rather than providing ACEs and ARBs standard of care, those more supportive care items. So we do think that there is a momentum that is building there. And I think so it's a combination of all of those things.

腎病科確實認真研究了 IgAN 患者，並真正考慮治療，而不是提供 ACE 和 ARB 標準護理，即那些更具支持性的護理計畫。所以我們確實認為那裡正在形成一種勢頭。我認為這是所有這些事情的結合。

And then, with regard to the 197 new prescribers. Are you able to assess in the market, how many of those -- their choice to add TARPEYO to the treatment paradigm? Was it based on The Lancet publication recently?

然後，關於 197 名新處方者。您能否評估市場上有多少人選擇將 TARPEYO 加入治療範例？它是根據最近發表的《刺胳針》發表的嗎？

There really isn't any way for us to know that. There's really no way for us to have a sense of that. And also, I mean, The Lancet publication came out in August, and so, I think we would probably expect that the consequences or any change in behavior really would fall now, it takes a little while for them to do that.

我們確實沒有任何辦法知道這一點。我們實在沒有辦法體會這一點。而且，我的意思是，《柳葉刀》雜誌於八月出版，因此，我認為我們可能會期望後果或行為的任何改變現在確實會下降，他們需要一段時間才能做到這一點。

I think that it also means -- I mean, I think again, this whole kind of interaction between nephrologist, there's a lot of peer-to-peer discussion communications. There's quite a lot of patients who are now having a very good outcomes. You have a lot of good stories from successful use of TARPEYO by physicians. And for that to build and really spread in the community, takes a little while. So I wouldn't expect to see the consequences really in this quarter, but more in Q4 and onwards.

我認為這也意味著——我的意思是，我再次認為，腎臟病專家之間的這種互動，有很多點對點的討論交流。現在有相當多的患者取得了很好的結果。您有很多醫生成功使用 TARPEYO 的好故事。要在社區中建立並真正傳播它，需要一段時間。因此，我預計不會在本季度真正看到後果，但會在第四季度及以後看到更多。

And certainly, not for Q3, those prescribers that you talk about. That's not -- that would be too soon.

當然，對於第三季度，你所說的那些處方者來說，情況並非如此。那不是——那還為時過早。

Okay. Thank you.

好的。謝謝。

Dan Akschuti, Pareto Securities.

丹‧阿克舒蒂 (Dan Akschuti)，帕累託證券公司。

Thank you for taking my questions. One would be on Europe. Could you share some details on why the launch is going very slow there by STADA?

感謝您回答我的問題。其中之一是關於歐洲。您能否分享一些有關 STADA 的發布速度如此緩慢的詳細資訊？

Yeah. So I think that obviously in Europe, you do have this kind of added complication of having to negotiate reimbursement rates with individual countries. That can really be quite a long, long process. I also think that there's been a perception, at least in Europe, about wanting to see maybe more long-term data prior to engaging in some of that conversation.

是的。所以我認為，顯然在歐洲，確實有這種額外的複雜性，必須與各國談判報銷率。這確實可能是一個相當漫長的過程。我還認為，至少在歐洲，人們有一種看法，希望在參與某些對話之前看到更長期的數據。

So that data obviously was available as of March. So I think that those are probably two reasons why we're seeing what we're seeing. But we are aware obviously of the fact that there are quite a few -- quite a lot -- I mean, quite a few negotiations ongoing in parallel at this point in time in order to kind of roll out in more geographic areas in Europe.

因此，截至三月份，該數據顯然是可用的。所以我認為這可能是我們看到現在所看到的情況的兩個原因。但我們顯然意識到這樣一個事實，即目前有相當多的談判正在並行進行，以便在歐洲更多地理區域推出。

And I think we should also add that they just receive reimbursement from NICE which is an important milestone, and very recent happening.

我認為我們還應該補充一點，他們剛剛收到 NICE 的報銷，這是一個重要的里程碑，而且是最近發生的。

Okay. Thank you. And a follow up on that would be in Germany specifically. Do you know of any specific challenges there since it is launch since September last year?

好的。謝謝。後續行動將專門在德國進行。您知道自去年9月推出以來，有哪些具體挑戰嗎？

So again, I think the only thing that I can think of obviously is the EMA label is slightly different, in terms of that it does give a very -- more line in the sand in terms of the actual subgroup population. So there is less, I guess, flexibility in terms of potentially prescribing to patients that are around that kind of cut off. So I think that that might have something do with it, but otherwise, I don't have any insights specifically. I don't Andy, if you have any insights.

再說一次，我認為我唯一能想到的顯然是 EMA 標籤略有不同，就實際亞組人口而言，它確實給出了更多的界限。因此，我認為，向處於這種界限的患者開處方的靈活性較差。所以我認為這可能與它有關，但除此之外，我沒有任何具體的見解。我不喜歡安迪，如果你有任何見解的話。

No, I agree. The feedback is it's a very strict interpretation of their label there. They're not displeased with the progress to date. They have about 200 patients in a year and change. But this is once again, as Renée said, this is due to a conditional label and a strict interpretation of that.

不，我同意。回饋是，這是對其標籤的非常嚴格的解釋。他們對迄今為止的進展並不不滿意。他們一年大約收治200名患者，並且不斷改變。但這又是，正如蕾妮所說，這是由於有條件的標籤和對其的嚴格解釋。

Okay, thank you. And another question would be, are you expecting further increase in R&D costs? And what was the rationale for the decrease in sales and marketing costs in Q3, or the reasons for that? And do you expect that to pick up again in Q4?

好的謝謝。還有一個問題是，您預計研發成本會進一步增加嗎？第三季銷售和行銷成本下降的原因是什麼？您預計第四季這種情況會再次回升嗎？

We're not expecting increased R&D cost per se. I think that what we're experiencing is just a bit of a lumpy effects in terms of some of these effects that relate to the fact that we're going into ending some of these trials, reading them out.

我們預計研發成本本身不會增加。我認為我們所經歷的只是一些不穩定的影響，其中一些影響與我們即將結束其中一些試驗並讀出它們有關。

And obviously, mainly the redesign if you like, of the protocol around the TRANSFORM study. And so, we've made no additional plans to invest or to have any additional cost apart from what we've already communicated. So I would actually ascribe this more to a certain lumpiness in these costs rather than anything that you should ascribe too much to quite honestly.

顯然，如果你願意的話，主要是重新設計圍繞 TRANSFORM 研究的協議。因此，除了我們已經溝通過的內容之外，我們沒有製定任何額外的投資計劃或任何額外的成本。因此，我實際上更多地將其歸因於這些成本的某種程度的波動，而不是您應該誠實地過多歸因的任何原因。

Okay, thank you. And regarding sales and marketing costs, they decreased this quarter. And do you expect them to increase again in Q4? And why did it go down in Q2?

好的謝謝。至於銷售和行銷成本，本季有所下降。您預計第四季度它們會再次增加嗎？為什麼第二季會下降？

I'm sorry. I had a little bit of a hard time hearing you. So are you referring to marketing cost going down?

對不起。我聽你說話有點困難。那您指的是行銷成本下降嗎？

Yes, in Q3. And do you expect them to increase again in Q4? And why did you spend less for sales and marketing in Q3 versus Q2?

是的，在第三季。您預計第四季度它們會再次增加嗎？為什麼您在第三季的銷售和行銷支出比第二季少？

Yes, I think it's just a coincidence. I'm a bit reluctant to give any guidance for the rest of the year on the sales and marketing side. But I think we -- as Renée has said, we don't expect any major increases for the year on the new investments we are planning for.

是的，我認為這只是一個巧合。我有點不願意在今年剩餘時間對銷售和行銷方面提供任何指導。但我認為，正如 Renée 所說，我們預計今年計劃的新投資不會大幅成長。

So again, I mean, I don't think anyone should read too much into quarterly changes at this at this time. While this is still in a launch mode and I think, things go a little bit up and down, but I don't think that there's any particular reason for it really.

所以，我的意思是，我認為此時任何人都不應該過度解讀季度變化。雖然這仍處於啟動模式，而且我認為事情會有些起起落落，但我認為這確實沒有任何特殊原因。

Okay. Thank you.

好的。謝謝。

Thanks.

謝謝。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑弗里斯。

Hi. Thanks for taking my questions. I was wondering if you can provide more perspective on the ongoing supplemental NDA review. Has FDA requested any additional analyses beyond what has been published in The Lancet, such as any data from your open-label extension study? And if you have label discussions or are you in the process of having label discussions currently?

你好。感謝您回答我的問題。我想知道您是否可以就正在進行的補充 NDA 審查提供更多觀點。除了《柳葉刀》上發表的內容之外，FDA 是否還要求進行任何其他分析，例如來自您的開放標籤擴展研究的任何數據？如果您有標籤討論，或者您目前正在進行標籤討論嗎？

So there's been no request for any information outside of the Phase-3 dataset. And then, and in terms of label negotiations, we would expect them to just start shortly.

因此，沒有人要求提供第三階段資料集之外的任何資訊。然後，就標籤談判而言，我們預計他們很快就會開始。

Got it. Okay. That's helpful. And what are your expectations for the label beyond the UPCR and eGFR changes? I guess, do you expect the hematuria benefit to be in there? And what about disease-modifying language based on the off-treatment profile?

知道了。好的。這很有幫助。除了 UPCR 和 eGFR 變化之外，您對標籤有何期望？我想，你期望那裡有血尿益處嗎？那麼基於停止治療情況的疾病修飾語言又如何呢？

I think it's very difficult to say at this point in time until we kind of have received comments from the agency once they have fully reviewed the file, so I think it's very difficult to say. I think that from our perspective, I think the data is pretty straightforward. I think that the -- we see a very pronounced effect and we see it across the entire study population.

我認為目前很難說，直到我們收到該機構的評論，一旦他們完全審查了文件，所以我認為很難說。我認為從我們的角度來看，我認為數據非常簡單。我認為，我們看到了非常明顯的效果，並且在整個研究人群中都看到了這種效果。

I think that in terms of -- I think, it's generally the FDA I would say is generally cautious around disease-modifying language. But we will see how they would look at this in the context of where they are, and they're exploring of accelerated approvals and full approvals in this indication.

我認為，我認為，整體而言，FDA 對疾病修飾語言普遍持謹慎態度。但我們將看到他們在當前情況下如何看待這個問題，並且他們正在探索針對此適應症的加速批准和全面批准。

So I think it's very, very difficult to say, but I think we have an extremely strong datasets, very consistent. There's not really much just like nothing gray in this, so we would expect it to be a fairly straightforward discussion. But it is always very difficult to know exactly what the agency will allow to be incorporated in the label or not.

所以我認為這非常非常困難，但我認為我們擁有非常強大的數據集，非常一致。這裡面並沒有什麼灰色的東西，所以我們希望這會是一個相當簡單的討論。但始終很難確切地知道該機構是否允許將哪些內容納入標籤中。

Got it. Makes sense. And last quick question, just based on your ASN data. You had the Chinese patient cohort data from the global Phase-3, do you have an understanding as to why the treatment effects were larger despite similar base patient baseline characteristics in this patient population? Does it have to do with this patient population just progressing faster on disease? Or if you can offer some perspective, that would be helpful.

知道了。說得通。最後一個簡單的問題，僅基於您的 ASN 數據。您有來自全球第三階段的中國患者群組數據，您是否了解為什麼儘管該患者族群的基本患者基線特徵相似，但治療效果更大？這是否與患者族群的疾病進展更快有關？或者如果您能提供一些觀點，那將會有所幫助。

Yeah. I mean, I think there could be different reasons for that one as you just outlined. I mean, it is a different patient population than Asian population and the rate of disease progression may be faster in that population. Overall, it's a smaller cohort as well, so there's more inherent -- there's more variability in the dataset. So then, maybe, that may be some contributions to what we're seeing as well.

是的。我的意思是，我認為正如您剛才概述的那樣，可能有不同的原因。我的意思是，這是一個與亞洲人群不同的患者人群，該人群的疾病進展速度可能更快。總的來說，它也是一個較小的隊列，因此有更多的內在——資料集中有更多的可變性。那麼，也許這也可能對我們所看到的有所貢獻。

Got it. Makes sense. Okay. Thanks for taking my questions.

知道了。說得通。好的。感謝您回答我的問題。

Arthur He, H.C. Wainwright.

何亞瑟，H.C.溫賴特。

Hey. Here again, team. Thanks for taking my question. So I just follow up on the Chinese market. Originally, have you been in discussion with Everest regarding the regulatory timeline as well as the initial -- the price -- pricing strategy with a neph company in China which we expect to be launching the next year?

嘿。又來了，團隊。感謝您提出我的問題。所以我只是跟進中國市場。最初，您是否曾與 Everest 就監管時間表以及我們預計將於明年推出的中國 Neph 公司的初始定價策略進行過討論？

So we have not heard anything from them that would indicate that anything different from the expectations that we've had all the time, which is that there isn't a decision expected before the end of the year. So that as far as we are aware, and we are obviously in contact with them on an ongoing basis, and that is what still is expected.

因此，我們沒有從他們那裡聽到任何表明與我們一直以來的預期不同的任何信息，即預計在今年年底之前不會做出決定。據我們所知，我們顯然正在持續與他們保持聯繫，這仍然是我們所期望的。

So we would expect to get a decision from the NMPA before the end of the year. So -- and after which obviously, we would go through the same process that we did in Europe. We would transfer our market authorization holding, et cetera, to Everest Medicines in order for them to be able to start commercializing.

因此，我們預計 NMPA 會在年底前做出決定。因此，顯然，在此之後，我們將經歷與歐洲相同的過程。我們會將我們的市場授權控股等轉讓給 Everest Medicines，以便他們能夠開始商業化。

We've not had any disclosure from Everest at this point in time in terms of any pricing. And so, I think that's going to have to be up to them I think to disclose once they have the approval in hand.

目前我們還沒有從珠穆朗瑪峰獲得任何定價方面的資訊。因此，我認為這必須由他們決定，一旦他們獲得批准，我認為就必須披露。

That sounds good, and thanks for the color. And just a quick one on TARPEYO. So after the sparsentan's fail in the eGFR data, did you see during this -- in the -- in your experience, did you see any patient switch from sparsentan to Nefecon? Or is there any color you can provide? Appreciate it.

聽起來不錯，謝謝你的顏色。簡單介紹一下 TARPEYO。那麼，在 Spassentan 在 eGFR 數據中失敗後，您是否看到在此期間 - 在 - 根據您的經驗，您是否看到任何患者從 Spasentan 轉為 Nefecon？或是有什麼顏色可以提供嗎？欣賞它。

That's really not a data that we have access to. We don't really know which patients are on sparsentan, and et cetera. So we wouldn't really know whether there was any switch with regards to that. We wouldn't have access to that information.

這確實不是我們有權存取的資料。我們真的不知道哪些病人正在服用稀疏坦，等等。所以我們真的不知道這方面是否有任何改變。我們將無法存取該資訊。

All right. So nothing further. Thanks for taking my question.

好的。所以沒有進一步的。感謝您提出我的問題。

Annabel Samimy, Stifel.

安娜貝爾·薩米米，斯蒂菲爾。

Hi. Good morning, everyone. Thanks for taking my question. I just wanted to know if you had any update on the average duration of treatment. And then, also, with regard to all the data that's coming out, published and at medical meetings, how are payers responding to some of this published data in terms of removing any friction points? I know it's pretty well covered but there's always some friction points.

你好。大家，早安。感謝您提出我的問題。我只是想知道您是否有關於平均治療持續時間的最新資訊。然後，對於所有正在發布、發布和在醫學會議上發布的數據，付款人在消除任何摩擦點方面對其中一些發布的數據有何反應？我知道它覆蓋得很好，但總是有一些摩擦點。

Is it resonating with them? Or are conversations awaiting more formal approval of a new label or a change in practice guidelines? Can you just talk about the work you're doing on that front. And do you need to change practice guidelines to really get full adoption from the nephrologists? Thanks.

是否與他們產生共鳴？或正在等待新標籤更正式的批准或實踐指南的變更？您能簡單談談您在這方面所做的工作嗎？您是否需要改變實踐指南才能真正得到腎臟病專家的全面採用？謝謝。

Andy, do you want to cover the market access piece?

安迪，你想報道市場進入部分嗎？

Sure, sure. Well, I can give you the duration treatment answer, is that we really have no updates. This is not something that's going to change quarter to quarter other than as we continue to say, it's being used, match the disease progression in most nephrologists.

一定一定。好吧，我可以給你一個治療持續時間的答案，那就是我們確實沒有更新。這不會每季度發生變化，除非我們繼續說，它正在被使用，與大多數腎臟科醫生的疾病進展相匹配。

But as far as the payer response, it's a process, right? So we have been getting some meetings already with payers, you try to get as many touch points as you can. So the first one came with topline data, then, the full publication. And then, we'll obviously have a new indication, and then, followed by that, we're anticipating guidelines to be updated probably early next year, sometime in the first half of next year.

但就付款人的反應而言，這是一個過程，對吧？因此，我們已經與付款人舉行了一些會議，您將嘗試獲得盡可能多的接觸點。因此，第一篇文章包含了主要數據，然後是完整的出版物。然後，我們顯然會有一個新的跡象，然後，我們預計指南可能會在明年初、明年上半年的某個時候更新。

So there's no changes of substance today that we really would discuss, but it's a process. And I think we're pretty encouraged that in certain areas of management, some of the friction that's created is a direct result of the current label, okay? So I think that that will change over time over the next 6 to 12 months as the label changes and guidelines change, but there's no set timing.

因此，今天我們確實不會討論任何實質的變化，但這是一個過程。我認為我們很受鼓舞的是，在某些管理領域，所產生的一些摩擦是當前標籤的直接結果，好嗎？因此，我認為隨著標籤的變化和指南的變化，這種情況將在未來 6 到 12 個月內發生變化，但沒有固定的時間。

Okay, great. Thank you.

好的，太好了。謝謝。

Rami Katkhuda, LifeSci Capital.

Rami Katkhuda，生命科學資本。

Hey, guys. Thanks for taking my questions as well. I guess, in addition to the open-label extension, you previously mentioned the potential for post-marketing studies to evaluate longer-term dosing, combination approaches, et cetera. I guess, any update on that front and whether you still plan to pursue those opportunities?

大家好。也感謝您回答我的問題。我想，除了開放標籤擴展之外，您之前還提到了上市後研究評估長期給藥、組合方法等的潛力。我想，這方面有什麼最新消息嗎？您是否仍計劃尋求這些機會？

Now, I think that these are normal discussions obviously that we have since we have a product on the market, but we haven't resolved on anything specific yet. But obviously, there are quite a lot of conversations ongoing, and a lot of these are obviously also driven directly by nephrologists. They're keen to use the product. They want to have some more information in terms of various treatment paradigm.

現在，我認為這些顯然是正常的討論，因為我們有產品上市，但我們還沒有就任何具體問題做出決定。但顯然，有相當多的對話正在進行，其中許多顯然也是由腎臟病專家直接推動的。他們熱衷於使用該產品。他們希望獲得有關各種治療模式的更多資訊。

So this is something that's a very constructive and positive conversation that we're having with nephrologists, but we haven't yet firmly agreed on any specifics around that. But we would expect that we will obviously conduct some of those Phase-4 studies going forward.

因此，這是我們與腎臟病專家進行的非常有建設性和積極的對話，但我們尚未就任何細節達成一致。但我們預計我們顯然會繼續進行一些第四階段研究。

But in terms of to actually come in terms of data that we will more formally release, that really is the open-label extension, which we hope to be able to do in the first half of next year. And then, obviously, together with the setanaxib data, that will also happen in the first half of next year. So those are the planned data releases for now, but we will keep you updated obviously as to when we embark or have all the details clarified as to any Phase-4 trial.

但就我們將更正式發布的實際數據而言，這確實是開放標籤擴展，我們希望能夠在明年上半年做到這一點。然後，顯然，與 setanaxib 數據一起，這也將在明年上半年發生。這些是目前計劃發布的數據，但我們將隨時向您通報我們何時開始或澄清任何第四階段試驗的所有細節。

Got it. Thanks so much.

知道了。非常感謝。

Johan Unnerus, Redeye.

約翰‧溫內魯斯，《紅眼》。

Great. Can you hear me?

偉大的。你聽得到我嗎？

Yes.

是的。

Excellent. Thanks for taking my question. Just a follow up to begin with. On the label review, in the FDA meeting, is there any reason to not believe that they would align to your study design earlier? There's obviously a more narrow label in the conditional approval than in the study.

出色的。感謝您提出我的問題。一開始只是一個後續行動。在 FDA 會議上的標籤審查上，是否有任何理由不相信它們會更早地與您的研究設計保持一致？顯然，有條件批准的標籤比研究中的標籤更窄。

Yeah. I mean, again, I mean, I think that the dataset is very clean and very straightforward. And as we've said, actually, we don't see -- we see the very consistent effect across the entire dataset. So from that perspective, we wouldn't expect there to be any basis for limiting the population from that perspective.

是的。我的意思是，我的意思是，我認為資料集非常乾淨且非常簡單。正如我們所說，實際上，我們沒有看到——我們看到整個數據集上非常一致的效果。因此，從這個角度來看，我們不認為有任何限制人口的基礎。

Interesting. Yes. And also, a follow up regarding China. Should we expect any milestone on the back of this approval?

有趣的。是的。還有關於中國的後續行動。我們是否應該期待這項批准後出現任何里程碑？

Yes, we have milestones for China about, as earlier communicated, we don't see them as material in the view of the quarter in the company's financing.

是的，正如之前所傳達的那樣，我們在中國有一些里程碑，但從公司本季的融資來看，我們認為這些里程碑並不重要。

Okay. And also, if I may. On the profile of your unique subscriber, especially as of today, would they be normal across the board profile? Or would you say that you have tendency to have more larger centers or smaller centers?

好的。另外，如果可以的話。在您的唯一訂閱者的個人資料中，特別是截至今天，他們的整體資料是否正常？或者你會說你傾向於擁有更多更大的中心還是更小的中心？

I don't know, Andy do you want to take that?

我不知道，安迪，你願意接受嗎？

I think it's generally spread out. There's no real formula for that or give you anything that's of substance as far as the differentiations and who's prescribing.

我認為一般都是分散的。沒有真正的公式可以解決這個問題，也沒有給你任何實質的內容，包括差異和誰在開處方。

There we go. Thank you.

我們開始吧。謝謝。

There are no more questions at this time, so I'll hand the word back to you, Renée.

現在沒有其他問題了，所以我會把話交還給你，蕾妮。

Thank you very much, and thank you all for listening into this Q3 report. And we look forward to sharing our full-year results, as well as the Q4 numbers in due time.

非常感謝大家，也感謝大家收聽第三季報告。我們期待在適當的時候分享我們的全年業績以及第四季度的數據。