Madrigal Pharmaceuticals Inc (MDGL) 2024 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to Madrigal Pharmaceuticals Third Quarter 2024 Earnings Conference Call. (Operator Instructions) As a reminder, today's conference call is being recorded. I'd like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

    美好的一天,感謝您的支持。歡迎參加 Madrigal Pharmaceuticals 2024 年第三季財報電話會議。(操作員說明)提醒一下,今天的電話會議正在錄音。我想介紹一下首席投資者關係官蒂娜·文圖拉女士。請繼續。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Thank you, Marvin. Good morning, everyone, and thank you for joining us to discuss Madrigal's third quarter 2024 earnings. We issued a press release this morning and have a slide deck that accompanies this webcast, which we'll post on the Investor Relations section of our website right after the call. On the call with me today is Bill Sibold, Chief Executive Officer; and Mardi Dier, Chief Financial Officer. They will provide prepared remarks, and then we'll take your questions.

    謝謝你,馬文。大家早安,感謝您加入我們討論 Madrigal 2024 年第三季的收益。我們今天早上發布了一份新聞稿,並在本次網路廣播中附帶了幻燈片,我們將在電話會議後立即將其發佈在我們網站的投資者關係部分。今天與我通話的是執行長 Bill Sibold;和財務長 Mardi Dier。他們將提供準備好的評論,然後我們將回答您的問題。

  • Our goal is to keep today's call to about 45 minutes. Please note, on slide 2, we will be making certain forward-looking statements today. We refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements. With that, I will now turn the call over to Bill on slide 3.

    我們的目標是將今天的通話時間控制在 45 分鐘左右。請注意,我們今天將在投影片 2 上做出某些前瞻性陳述。我們建議您參閱我們向 SEC 提交的文件,以討論可能導致實際結果與前瞻性陳述不同的風險。現在,我將把電話轉給幻燈片 3 上的 Bill。

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Well, thanks, Tina. Good morning, and thanks for joining. I'll cover three topics on our call this morning. First, an update on the Rezdiffra launch. Second, how we see the NASH treatment landscape evolving over time.

    嗯,謝謝,蒂娜。早安,感謝您的加入。我將在今天早上的電話會議上討論三個主題。首先是 Rezdiffra 發布的最新情況。其次,我們如何看待 NASH 治療格局隨時間的演變。

  • And third, the progress we've made to strengthen our long-term leadership position in NASH, including completing enrollment of our cirrhosis OUTCOMES trial. Let's start with the US. Rezdiffra launch on slide 4. As we announced in our earnings release this morning, we delivered an exceptional quarter, generating $62 million in net sales. This was another strong demand quarter with inventory at the low end of our expected two to four week range.

    第三,我們在加強 NASH 領域的長期領導地位方面取得的進展,包括完成肝硬化 OUTCOMES 試驗的入組。我們先從美國開始。Rezdiffra 在投影片 4 上發布。正如我們今天早上在財報中宣布的那樣,我們的季度業績表現出色,實現了 6,200 萬美元的淨銷售額。這是另一個需求強勁的季度,庫存處於我們預計的兩到四周範圍的低端。

  • We're now six months into the launch and the feedback we're hearing from prescribers continues to be very positive. They're finding it easier to prescribe Rezdiffra to their patients thanks to our efforts to wire the system and the improved access we've secured. They also have high confidence in Rezdiffra's real world performance as an effective, well-tolerated once a day pill supported by positive patient experiences to date. Healthcare providers are beginning to recognize Rezdiffra as standard of care, reinforcing its position as the foundational therapy for NASH. And while we are still early in the launch phase, we're continuing to see great progress across all key performance metrics.

    我們現在已經推出六個月了,我們從處方者那裡聽到的反饋仍然非常積極。他們發現,由於我們在系統連接方面所做的努力以及我們所確保的改進的訪問權限,為患者開立 Rezdiffra 處方變得更加容易。他們也對 Rezdiffra 作為一種有效、耐受性良好的每日一次藥丸的實際表現充滿信心,並得到迄今為止積極的患者體驗的支持。醫療保健提供者開始將 Rezdiffra 視為護理標準,鞏固了其作為 NASH 基礎療法的地位。雖然我們仍處於啟動階段的早期,但我們繼續看到所有關鍵效能指標都取得了巨大進展。

  • This gives us confidence in our strong growth expectations for Rezdiffra and reinforces that the launch is tracking in line with other best-in-class specialty medicine blockbuster launches. So let's start with patients. As a reminder, we're focused on the 315,000 patients diagnosed with NASH with moderate to advanced fibrosis. We ended the quarter with greater than 6,800 patients on Rezdiffra. The figure represents patients on drug or the bottom of the patient funnel and the most rigorous metric to measure.

    這讓我們對 Rezdiffra 的強勁成長預期充滿信心,並強化了該產品的推出與其他一流的專科藥物重磅產品的推出保持一致。那麼就讓我們從患者開始吧。提醒一下,我們關注的是 315,000 名被診斷出患有中度至晚期纖維化 NASH 的患者。本季結束時,我們有超過 6,800 名患者使用 Rezdiffra。此圖代表正在服用藥物的患者或患者漏斗的底部以及最嚴格的衡量指標。

  • By comparison, we ended the second quarter with more than 2,000 patients on Rezdiffra. We know that the early quarters of a launch are crucial and often predictive of future success. During these initial quarters, we are closely tracking our metrics, including the pace of patient adds against a group of top tier specialty medicine launches. We are steadily adding patients at a rate consistent with those benchmarks. As we discussed last quarter, we have dedicated significant effort with our field and patient support teams to reduce the time it takes for prescriptions to be filled.

    相較之下,第二季結束時,我們有超過 2,000 名患者使用 Rezdiffra。我們知道,產品發布的早期階段至關重要,並且往往預示著未來的成功。在最初的幾個季度中,我們正在密切追蹤我們的指標,包括針對一組頂級專科藥物上市的患者增加速度。我們正在以與這些基準一致的速度穩定增加患者。正如我們上季度所討論的,我們與我們的現場和患者支援團隊付出了巨大的努力,以減少配藥所需的時間。

  • Thanks to their outstanding work, we achieved our 6-month goal with time-to-fill trending at 30 days or less. We're also encouraged by the progress we've made with payers. One of our ambitious pre-launch objectives was to secure coverage for 80% of commercial lives by year-end, and we achieved this goal during the third quarter, a full quarter ahead of schedule. At quarter end, more than 80% of commercial lives have coverage in place for Rezdiffra. Notably, greater than 95% of Rezdiffra covered lives accept non-invasive tests, or NITs, and do not require a biopsy, in line with current standard of care.

    感謝他們的出色工作,我們實現了 6 個月的目標,填充時間趨勢為 30 天或更短。我們與付款人的進展也讓我們感到鼓舞。我們雄心勃勃的啟動前目標之一是確保到年底涵蓋 80% 的商業生活,我們在第三季度實現了這一目標,比計劃提前了整整一個季​​度。截至季末,超過 80% 的商業生活都涵蓋了 Rezdiffra。值得注意的是,超過 95% 的 Rezdiffra 核保患者接受非侵入性檢測(NIT),並且不需要活檢,這符合當前的護理標準。

  • As we noted last quarter, Medicaid coverage was in place as of July 1 and we expect Medicare coverage to begin on January 1 of next year. Currently, Medicare patients are accessing Rezdiffra through the medical exception process with prior authorization requirements aligned with our label. This process has been smooth, allowing patients to readily access Rezdiffra. We expect many Medicare plans to start to list Rezdiffra in 2025, and would expect this favorable access to continue. Our business mix has been running in line with our expectations, with commercial at 50% to 55%, Medicare at 30% to 35% and Medicaid and other at about 10%.

    正如我們上季度指出的那樣,醫療補助覆蓋範圍於 7 月 1 日生效,我們預計醫療保險覆蓋範圍將於明年 1 月 1 日開始。目前,Medicare 患者正在透過醫療例外流程使用 Rezdiffra,且事先授權要求與我們的標籤一致。這個過程很順利,讓患者可以輕鬆使用 Rezdiffra。我們預計許多醫療保險計劃將在 2025 年開始將 Rezdiffra 上市,並預計這種優惠的准入將繼續下去。我們的業務組合一直符合我們的預期,其中商業佔50%至55%,醫療保險佔30%至35%,醫療補助和其他佔10%左右。

  • Moving on to prescribers. As a reminder, we have 14,000 total targets with a primary focus on the top 6,000. These include hepatologists and gastroenterologists who treat the majority of the 315,000 diagnosed F2, F3 patients. The goal with any successful launch is to expand both the breadth and depth of prescribing, and we're making strong progress on both fronts. In the third quarter, around 40% of our top targets prescribed Rezdiffra, doubling the 20% penetration rate from the second quarter.

    轉向處方者。提醒一下,我們總共有 14,000 個目標,主要關注前 6,000 個。其中包括肝病學家和胃腸病學家,他們治療了 315,000 名確診的 F2、F3 患者中的大多數。任何成功推出的目標都是擴大處方的廣度和深度,我們在這兩個方面都取得了巨大進展。第三季度,大約 40% 的首要目標使用了 Rezdiffra,比第二季度 20% 的滲透率翻了一番。

  • Our top targets are continuing to write more than 75% of Rezdiffra prescriptions, giving us confidence that we're targeting the right prescribers with our efforts. And as we look at depth among our top targets, we are seeing an increasing number of prescriptions written per prescriber as well. The launch is off to a fantastic start with all of our metrics either meeting or exceeding our high expectations. Our success to date has also been driven by our ability to continue to wire the system, as noted on slide 5. This is a first-in-disease launch where the market needs to be built from the ground up.

    我們的首要目標是繼續為超過 75% 的 Rezdiffra 處方開處方,這讓我們相信我們的努力瞄準了正確的處方者。當我們深入研究首要目標時,我們發現每位處方者開出的處方數量也不斷增加。這次發布有一個美妙的開始,我們的所有指標都達到或超越了我們的高期望。如幻燈片 5 所示,我們迄今為止的成功也得益於我們繼續連接系統的能力。這是首次針對疾病的上市,需要從頭開始建立市場。

  • Prior to Rezdiffra's approval in March, there had never been a prescription written for NASH. Our goal has been to drive changes in clinical practice and develop processes for efficient patient and prescription flow to establish a strong foundation that will support our peak sales expectations. While we still have a lot of work left to do, we have made terrific progress to date. Success here allows us to strengthen our leadership position in NASH and achieve one of the most successful specialty launches in the industry. A key factor of our success thus far has been Rezdiffra's strong value proposition, which has been recognized by healthcare providers, payers and patients.

    在 Rezdiffra 三月獲得批准之前,從未有過針對 NASH 的處方。我們的目標是推動臨床實踐的變革,並開發高效的患者和處方流程流程,為支持我們的峰值銷售預期奠定堅實的基礎。雖然我們還有很多工作要做,但迄今為止我們已經取得了巨大進展。這裡的成功使我們能夠加強我們在 NASH 領域的領導地位,並實現業內最成功的專業產品推出之一。迄今為止,我們成功的關鍵因素是 Rezdiffra 強大的價值主張,該主張已得到醫療保健提供者、付款人和患者的認可。

  • As a reminder, Rezdiffra is a liver-directed medicine that has set a high bar for efficacy and safety. It's the only medicine to achieve statistically significant results on both endpoints in Phase III, NASH resolution and fibrosis improvement. Importantly, Rezdiffra stopped or improved fibrosis in more than 80% of patients after one year of therapy. It's a once-a-day pill that's well tolerated with simple dosing. It's this favorable profile that should allow patients to stay on the medicine over time.

    需要提醒的是,Rezdiffra 是一種針對肝臟的藥物,在功效和安全性方面設定了很高的標準。它是唯一在 III 期臨床終點、NASH 消退和纖維化改善方面均取得統計學顯著結果的藥物。重要的是,Rezdiffra 在治療一年後,超過 80% 的患者停止或改善了纖維化。它是一種每日一次的藥丸,劑量簡單,耐受性良好。正是這種有利的情況應該讓患者能夠長期堅持用藥。

  • Early indicators suggest persistency in line with other well-tolerated oral medicines. It's clear from these real-world results that Rezdiffra is well on its way to becoming the foundational therapy for NASH patients with moderate to advanced liver fibrosis. We believe that this strong product profile will provide a sustainable advantage for Rezdiffra when new competition emerges. The next potential entrant could be from the GLP-1 class. As we look at the profile of semaglutide on slide 7, you'll see that Rezdiffra compares very favorably across key attributes.

    早期指標顯示其持久性與其他耐受性良好的口服藥物一致。從這些現實世界的結果可以清楚看出,Rezdiffra 正在成為中度至晚期肝纖維化 NASH 患者的基礎療法。我們相信,當新的競爭出現時,這種強大的產品形象將為 Rezdiffra 提供可持續的優勢。下一個潛在的進入者可能來自 GLP-1 類別。當我們查看幻燈片 7 上索馬魯肽的概況時,您會發現 Rezdiffra 在關鍵屬性方面的比較非常有利。

  • Importantly, more patients taking a GLP-1 in the real world struggle to stay on treatment long term. In fact, data shows that only about 30% of patients with obesity remained on semaglutide after one year, which is especially important given their NASH study is 72 weeks. For NASH patients with moderate to advanced fibrosis who are one or two steps away from having cirrhosis, healthcare providers will want to be confident that their patient is going to take his or her medicine consistently over time to see an effect. So as we look ahead and consider the potential impact of a GLP-1 launch on the market on slide 8, we believe it will further accelerate the growth opportunity for Rezdiffra. We are focused on the 315,000 patients diagnosed with moderate to advanced NASH fibrosis.

    重要的是,在現實世界中,有更多服用 GLP-1 的患者難以長期接受治療。事實上,數據顯示,只有約 30% 的肥胖患者在一年後仍繼續服用索馬魯肽,考慮到他們的 NASH 研究為期 72 週,這一點尤其重要。對於患有中度至晚期纖維化且距離肝硬化僅一兩步之遙的 NASH 患者,醫療保健提供者希望確信他們的患者會隨著時間的推移持續服藥以看到效果。因此,當我們展望未來並考慮幻燈片 8 上 GLP-1 的推出對市場的潛在影響時,我們相信它將進一步加速 Rezdiffra 的成長機會。我們重點關注 315,000 名被診斷出患有中度至晚期 NASH 纖維化的患者。

  • On its own, this is an attractive specialty market, and we are still early in the journey with 2% of those patients on treatment. Novo Nordisk is focused on a much larger population of both diagnosed and undiagnosed patients, many multiples of our 315,000. Their efforts will expand the market, and most importantly, benefit patients with NASH by increasing awareness, patient screening, diagnosis and treatment. And this significant expansion will also benefit Rezdiffra, both as the foundational therapy in NASH for first-line patients and from the high overall discontinuation rate of semaglutide. And there is clearly room in this large and underpenetrated market for multiple mechanisms to treat this challenging disease.

    就其本身而言,這是一個有吸引力的專業市場,我們仍處於早期階段,其中 2% 的患者正在接受治療。諾和諾德專注於更大規模的確診和未確診患者群體,是我們 315,000 名患者的許多倍。他們的努力將擴大市場,最重要的是,透過提高意識、患者篩檢、診斷和治療,使 NASH 患者受益。這一顯著擴張也將使 Rezdiffra 受益,因為 Rezdiffra 既可以作為一線患者 NASH 的基礎療法,也可以受益於索馬魯肽的高總體停藥率。在這個龐大且滲透不足的市場中,顯然有許多機制來治療這種具有挑戰性的疾病的空間。

  • We expect combination therapy to be part of the treatment paradigm. In fact, it's already happening. Approximately 25% of Rezdiffra patients today are using Rezdiffra in combination with GLP-1s to treat their comorbidities, and the percentage is likely much higher when including patients that have previously been on a GLP-1. In summary, we continue to be optimistic about the future market dynamics. Between Rezdiffra's attractive real-world profile, the significant opportunity to penetrate our target market of 315,000 and the potential for significant market expansion beyond that with new competition, we are confident that Rezdiffra can continue to deliver strong growth in the years ahead.

    我們期望聯合療法成為治療範例的一部分。事實上,這已經發生了。如今,大約 25% 的 Rezdiffra 患者將 Rezdiffra 與 GLP-1 聯合使用來治療其合併症,如果包括先前接受過 GLP-1 治療的患者,這一比例可能會更高。綜上所述,我們對未來市場動態持續看好。Rezdiffra 具有吸引力的現實形象、滲透 315,000 目標市場的重大機會以及新競爭帶來的重大市場擴張潛力,我們相信 Rezdiffra 能夠在未來幾年繼續實現強勁增長。

  • We're also pursuing additional growth opportunities for Rezdiffra beyond our launch in the US, as highlighted on slide 9. This includes our efforts in Europe, where we are preparing for a potential second half '25 launch of Rezdiffra pending EMA approval. Additionally, we're working to bring Rezdiffra's benefits to patients with NASH cirrhosis. Earlier this month, we completed enrollment in our MAESTRO-NASH OUTCOMES trial, marking a significant milestone for Madrigal in the NASH field. Subject to regulatory approval, positive results could make Rezdiffra the first medicine for patients with compensated NASH cirrhosis.

    正如幻燈片 9 所強調的那樣,除了在美國推出之外,我們還在為 Rezdiffra 尋求更多的成長機會。這包括我們在歐洲的努力,我們正在為 25 年下半年可能推出的 Rezdiffra 做準備,等待 EMA 批准。此外,我們正在努力將 Rezdiffra 的益處帶給 NASH 肝硬化患者。本月早些時候,我們完成了 MAESTRO-NASH OUTCOMES 試驗的註冊,標誌著 Madrigal 在 NASH 領域的一個重要里程碑。經監管部門批准,積極的結果可能使 Rezdiffra 成為代償性 NASH 肝硬化患者的第一種藥物。

  • Cirrhosis patients are at a high risk of progressing to serious liver-related outcomes. While F2, F3 patients have a 10 to 17 times greater risk of liver-related mortality, in F4 or cirrhosis patients that risk is 42 times higher. This stark statistic underscores the urgent need for an effective treatment in this vulnerable population. Results from our OUTCOMES trial in cirrhosis patients as well as the OUTCOMES portion of our MAESTRO-NASH trial in F2, F3 patients could very well position Rezdiffra as the only approved therapy with OUTCOMES data in NASH in this decade, providing us with data years ahead of the competition. I'd also like to highlight two exciting developments in our R&D organization that further strengthen our leadership in NASH.

    肝硬化患者進展為嚴重的肝臟相關後果的風險很高。F2、F3 患者的肝臟相關死亡風險高出 10 至 17 倍,而 F4 或肝硬化患者的風險則高出 42 倍。這一嚴峻的統計數據強調了這個弱勢群體迫切需要有效的治療。我們在肝硬化患者中進行的OUTCOMES 試驗的結果以及我們在F2、F3 患者中進行的MAESTRO-NASH 試驗的結果部分可以很好地將Rezdiffra 定位為近十年來唯一獲得批准的具有NASH OUTCOMES 數據的療法,為我們提供了未來幾年的數據比賽的。我也想強調我們研發組織的兩個令人興奮的發展,這些發展進一步加強了我們在 NASH 領域的領導地位。

  • Dr. Michael Charlton has joined us as Head of Clinical Development. As a world-renowned expert in NASH, we are thrilled he decided to join Madrigal at such a pivotal time for the company. Secondly, we are preparing for a strong presence at the upcoming AASLD Liver Meeting in mid-November in San Diego, where Rezdiffra will be in the spotlight as the first ever approved therapy for NASH. Madrigal is leading the NASH field to advance the science.

    Michael Charlton 博士加入我們,擔任臨床開發主管。身為世界知名的 NASH 專家,我們很高興他決定在公司如此關鍵的時刻加入 Madrigal。其次,我們正準備在即將於 11 月中旬在聖地亞哥舉行的 AASLD 肝臟會議上強勢亮相,Rezdiffra 將作為第一個獲批的 NASH 療法而受到關注。Madrigal 正在引領 NASH 領域推動科學發展。

  • Our resmetirom development program produced more NASH abstracts at AASLD than any other program. Moreover, AASLD recently released guidance that reinforces Rezdiffra's role as the foundational therapy for NASH following similar recommendations from the EASL guidelines in June and the expert panel in July. Clinicians now have multiple guidance documents to support patient identification, treatment initiation and monitoring. Before I hand it over to Mardi, let me briefly summarize our progress on slide 10. This quarter, we delivered outstanding results, meeting or exceeding our ambitious targets.

    我們的 resmetirom 開發項目在 AASLD 上產生的 NASH 摘要比其他項目都多。此外,繼 6 月 EASL 指南和 7 月專家小組的類似建議之後,AASLD 最近發布了指南,強化了 Rezdiffra 作為 NASH 基礎療法的作用。臨床醫生現在擁有多個指導文件來支持患者識別、治療啟動和監測。在將其交給 Mardi 之前,讓我簡要總結一下我們在投影片 10 上取得的進展。本季度,我們取得了出色的業績,達到或超越了我們的宏偉目標。

  • Net sales of $62 million driven by strong demand, greater than 6,800 patients on Rezdiffra, more than 80% of commercial lives covered, achieving this milestone a full quarter ahead of schedule. About 40% of our top targets are prescribing Rezdiffra, and we continue to drive both breadth and depth with significant opportunity ahead. The completed enrollment of our NASH cirrhosis outcomes trial, one step closer to bringing the first therapy to market for this vulnerable patient population. And we're tracking well to launch Rezdiffra in Europe in the second half of 2025 pending EMA approval. With that, I'll turn it over to Mardi.

    強勁需求推動淨銷售額達 6,200 萬美元,Rezdiffra 患者超過 6,800 名,覆蓋超過 80% 的商業生活,提前整整一個季​​度實現了這一里程碑。我們約 40% 的首要目標正在開立 Rezdiffra 處方,我們將繼續推動廣度和深度的發展,並抓住未來的重大機會。我們的 NASH 肝硬化結果試驗已完成註冊,距離為這一弱勢患者群體推出第一種療法又更近了一步。我們正在順利進行,將於 2025 年下半年在歐洲推出 Rezdiffra,等待 EMA 批准。這樣,我就把它交給 Mardi。

  • Mardi Dier - Chief Financial Officer, Senior Vice President

    Mardi Dier - Chief Financial Officer, Senior Vice President

  • Thank you, Bill. Earlier today, we issued a press release with our final -- our full financial results. So I will provide you a few highlights of the third quarter of 2024, as noted on slide 11. US net sales for the quarter totaled $62 million.

    謝謝你,比爾。今天早些時候,我們發布了一份新聞稿,其中包含我們的最終完整財務表現。因此,我將為您提供 2024 年第三季的一些亮點,如幻燈片 11 所示。該季度美國淨銷售額總計 6,200 萬美元。

  • As we've mentioned previously, we expect inventory to run between two to four weeks for Rezdiffra, which is typical for a specialty medicine. As Bill noted, this was another strong demand quarter with inventory at the low end of that range. Our gross to net was again favorable to our expectation this quarter as our co-pay assistance program utilization was lower than anticipated for the third quarter. As we've said before, we expect gross to net to be choppy quarter-to-quarter, particularly early in the launch. R&D expenses for the third quarter of 2024 were $68.7 million compared to $71 million in the third quarter of 2023.

    正如我們之前提到的,我們預計 Rezdiffra 的庫存將持續兩到四個星期,這對於特殊藥物來說是典型的。正如比爾指出的那樣,這是另一個需求強勁的季度,庫存處於該範圍的低端。本季我們的毛淨值再次符合我們的預期,因為我們的共同支付援助計畫利用率低於第三季的預期。正如我們之前所說,我們預計季度淨毛額將出現波動,尤其是在發布初期。2024 年第三季的研發費用為 6,870 萬美元,而 2023 年第三季的研發費用為 7,100 萬美元。

  • We continue to anticipate relatively stable R&D expenses this year compared to last year. SG&A expenses were $107.6 million compared to $27.6 million for the third quarter of 2023. This year-over-year increase was expected due primarily to the expansion of our commercial operations in the US following Rezdiffra's approval in March. Turning to our balance sheet.

    我們繼續預計今年的研發費用與去年相比相對穩定。SG&A 費用為 1.076 億美元,而 2023 年第三季為 2,760 萬美元。這一同比增長是預期的,主要是由於 Rezdiffra 三月獲得批准後我們在美國商業業務的擴張。轉向我們的資產負債表。

  • As of September 30, we had $1 billion in cash, cash equivalents, restricted cash and marketable securities. With this strong cash position, we are well resourced to support the ongoing launch of Rezdiffra in both the US and our planned launch in Europe. I'll now turn the call back over to Tina.

    截至 9 月 30 日,我們擁有 10 億美元現金、現金等價物、限制性現金和有價證券。憑藉強大的現金狀況,我們擁有充足的資源來支持 Rezdiffra 在美國的持續推出以及我們計劃在歐洲的推出。我現在將把電話轉回給蒂娜。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Thanks, Mardi. Let's move into the Q&A portion of the call. So Marvin, please provide the instructions for the Q&A session, and we'll get started.

    謝謝,瑪迪。讓我們進入通話的問答部分。馬文,請提供問答環節的說明,我們就開始吧。

  • Operator

    Operator

  • (Operator Instructions) Yasmeen Rahimi, Piper Sandler.

    (操作說明)Yasmeen Rahimi、Piper Sandler。

  • Yasmeen Rahimi - Analyst

    Yasmeen Rahimi - Analyst

  • Congrats on an amazing quarter, really incredible. Team, I guess, question is, given the strong performance, could you maybe talk to us about what your forecast or what your thoughts are around moving forward into fourth quarter and sort of growth into 2025? And I'll jump back into the queue.

    恭喜您度過了一個令人驚嘆的季度,真的令人難以置信。團隊,我想,問題是,考慮到強勁的表現,您能否與我們談談您對進入第四季度以及 2025 年增長的預測或想法?我會跳回到隊列中。

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Yes, we're really thrilled with how the launch is progressing. The team is executing at all levels, made great progress on coverage, adding prescribers, adding patients. We're really off to a very strong start. And as I said, the trajectory in early launch quarters is an important indicator for future success. We have our own internal metrics that we look at, but we're also benchmarking ourselves against about 10 specialty launches in the last 10 years that are unmitigated successes.

    是的,我們對發布的進展感到非常興奮。該團隊正在各個層面執行,在覆蓋範圍、增加處方者、增加患者方面取得了巨大進展。我們確實有了一個非常強勁的開端。正如我所說,早期發布季度的軌跡是未來成功的重要指標。我們有自己的內部衡量標準,但我們也會根據過去 10 年中大約 10 個取得巨大成功的專業產品的推出來對自己進行基準測試。

  • These are great launches. And we're doing really great against these benchmarks as well. And looking at those benchmarks for growth, what you typically see in the third quarter of launch of growth is in the 50% zone on average. And like with the other metrics, we're tracking well on this. So we're off to a great start.

    這些都是很棒的發布。我們在這些基準測試中也做得非常好。從這些成長基準來看,您通常會看到,第三季的成長平均處於 50% 的區域。與其他指標一樣,我們對此進行了很好的追蹤。所以我們有了一個好的開始。

  • So maybe for 2025, Mardi, you want to comment on that?

    那麼,也許到 2025 年,Mardi,您想對此發表評論嗎?

  • Mardi Dier - Chief Financial Officer, Senior Vice President

    Mardi Dier - Chief Financial Officer, Senior Vice President

  • Yes, absolutely. Like Bill said, we're off to a strong start. We're really pleased with our third quarter growth and what we're looking forward into fourth quarter. But absolutely, we want to see how 2024 plays out before we provide any more specific points of view on 2025. But what we can say is you look at fiscal year 2025, and based on our performance of third quarter and into fourth quarter, we would anticipate that 2025 expectations to increase some to account for this robust growth that we're generating.

    是的,絕對是。正如比爾所說,我們有了一個好的開始。我們對第三季的成長以及對第四季度的展望感到非常滿意。但毫無疑問,我們希望先看看 2024 年的情況如何,然後再對 2025 年提供更具體的觀點。但我們可以說的是,看看 2025 財年,根據我們第三季和第四季的業績,我們預計 2025 年的預期會增加一些,以應對我們正在產生的強勁成長。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Marvin, next question, please.

    馬文,請下一個問題。

  • Operator

    Operator

  • Eliana Merle, UBS.

    埃利安娜梅爾,瑞銀。

  • Eliana Merle - Analyst

    Eliana Merle - Analyst

  • Congrats on the quarter. Just curious what you're seeing in terms of the cadence of new patient starts. Are you seeing a similar number of new patients starts per week or month? Or is the number of new patients starts accelerating? And then just second, in terms of the ESSENCE data, what are your expectations for whether the payers will require a step through with the GLP-1 if the ESSENCE data shows a very strong fibrosis benefit?

    恭喜本季。只是好奇您在新患者開始的節奏方面看到了什麼。您是否發現每週或每月新增的新患者數量相似?或是新患者的數量開始加速?其次,就 ESSENCE 資料而言,如果 ESSENCE 資料顯示出非常強的纖維化益處,您對付款人是否需要使用 GLP-1 的預期是什麼?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • I appreciate the question. So yes, as we said, we have been continuing to steadily add patients. We have -- there's a lot of interest out there. You have to remember, we're not at steady state yet either, right? We haven't fully penetrated all of the prescribing physicians.

    我很欣賞這個問題。所以,是的,正如我們所說,我們一直在繼續穩定地增加患者。我們有很多人對此感興趣。你必須記住,我們還沒有達到穩定狀態,對吧?我們還沒有完全滲透到所有的處方醫生。

  • So that's going to take longer as we continue to wire the system. And then you get to your baseline that you start to grow from in a patient add perspective. But we're making progress every day, adding new prescribers, new patients, et cetera. So that's -- we expect this pace to continue.

    因此,隨著我們繼續連接系統,這將需要更長的時間。然後你就達到了你的基線,你開始從病人的角度成長。但我們每天都在進步,增加了新的處方者、新的病人等等。因此,我們預計這種步伐將持續下去。

  • Eliana Merle - Analyst

    Eliana Merle - Analyst

  • And the second question was around ESSENCE and step through GLP-1.

    第二個問題是圍繞 ESSENCE 和 GLP-1 的步驟。

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Yes. So look -- thanks for that as well. To date, we haven't seen any requirement for step-through. Look, we're waiting to see what the results look like as well. And when we get the results, we're really trying to -- we're going to want to try to understand what the data says and doesn't say.

    是的。所以看——也謝謝你。到目前為止,我們還沒有看到任何單步執行的要求。瞧,我們也在等著看結果。當我們得到結果時,我們真的很努力——我們會想要嘗試理解數據說了什麼和沒有說什麼。

  • And we'll have a number of questions to really probe a little bit deeper on, because, as you know, top line readouts don't always translate into labels so well. So some of the things we're going to be looking for are the following: What do the intent to treat results look like? How are discontinuations handled? What percent of patients reach the 2.4 milligram therapeutic dose? And even things like how are the biopsies read, because that can result in higher response rate as you've seen in other NASH trials.

    我們將有很多問題需要真正深入探討,因為如您所知,頂線讀數並不總是能很好地轉化為標籤。因此,我們要尋找的一些內容如下:處理結果的意圖是什麼樣的呢?停產如何處理?達到 2.4 毫克治療劑量的患者比例是多少?甚至諸如活檢如何讀取之類的問題,因為這可以導致更高的反應率,正如您在其他 NASH 試驗中看到的那樣。

  • But in the end, we're talking about a well-controlled trial here versus real-world practice. And that's where I think the profiles really matter. That's where we're really set up for that. So we'll see what happens with the results of the trial to see what happens, if anything happens with payers. Now what I will just reinforce is we are in a really strong position.

    但最後,我們討論的是一個控制良好的試驗與現實世界的實踐。這就是我認為個人資料真正重要的地方。這就是我們真正為此做好準備的地方。因此,我們將看看試驗結果會發生什麼,看看付款人是否發生任何情況。現在我要強調的是,我們處於非常有利的地位。

  • We have a very good profile. We've had ongoing dialogue with payers now for well over a year. They understand the profile of the product and what it can offer. So we feel like we're in a very strong position as we go into any potential readout that takes place from ESSENCE.

    我們有很好的形象。我們與付款人的持續對話已經一年多了。他們了解產品的概況及其所能提供的功能。因此,當我們進入 ESSENCE 發生的任何潛在讀數時,我們感覺自己處於非常有利的位置。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. Marvin, next question, please.

    偉大的。馬文,請下一個問題。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什·特瓦里,杰弗里斯。

  • Manoj Eradath - Analyst

    Manoj Eradath - Analyst

  • This is Manoj in for Akash. Just one. Which trial are you more confident on hitting on outcomes, the expansion of MAESTRO-NASH or like the F4 patient trial? Why are you confident that you could show a definite benefit in these late-stage patients?

    這是 Manoj 代替 Akash。只有一個。您對哪項試驗的結果更有信心,是 MAESTRO-NASH 的擴展還是 F4 患者試驗?為什麼您有信心對這些晚期患者顯示出明確的益處?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Look, we're confident in both trials. Of course, we don't have the answer yet though, so we have to wait and see what that looks like. We have -- for the cirrhosis trial, we had a group of 180 cirrhosis patients in the NAFLD-1 trial that went on to the open label. It was based on some of the results that we are seeing there that we feel that there's a very good reason why Rezdiffra may work in this population. In fact, Rezdiffra has been referred to as the kind of master regulator for fibrosis.

    看,我們對這兩項試驗都充滿信心。當然,我們還沒有答案,所以我們必須等待,看看會是什麼樣子。對於肝硬化試驗,我們有一組 180 名肝硬化患者參加 NAFLD-1 試驗,該試驗繼續進行開放標籤。基於我們在那裡看到的一些結果,我們認為 Rezdiffra 有充分的理由可以在這群人中發揮作用。事實上,Rezdiffra 被稱為纖維化的主要調節劑。

  • So we think that this is something that there's a good chance that we hit. We're, of course, always going to push the science here and ask the question about, what does the community want to learn about and know? We think, especially through the cirrhosis trial, that there's going to be a ton of learnings for the community overall. We're out in front. We're leading these efforts.

    所以我們認為這是我們很有可能實現的目標。當然,我們總是會在這裡推動科學發展,並提出這樣的問題:社區想要了解和了解什麼?我們認為,特別是透過肝硬化試驗,整個社區將會學到很多。我們就在前面。我們正在領導這些努力。

  • It's something that we think as a leader it's important to do to drive the science. So we'll have to see what the results say. But based upon the really significant interest in the cirrhosis trial, we know that the community is interested in hearing the answer to the question. You saw that we had about 840 patients that enrolled, and that was exceeding expectations really just because of the interest in the trial.

    我們認為,身為領導者,推動科學發展非常重要。所以我們必須看看結果如何。但基於對肝硬化試驗的真正濃厚興趣,我們知道社區有興趣聽到這個問題的答案。你看到我們有大約 840 名患者入組,這超出了預期,這真的只是因為人們對試驗感興趣。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Marvin, next question, please.

    馬文,請下一個問題。

  • Operator

    Operator

  • Ritu Baral, TD Cowen.

    裡圖·巴拉爾,TD·考恩。

  • Ritu Baral - Analyst

    Ritu Baral - Analyst

  • Congratulations on the quarter, but I'm going to complain a little anyway. I wanted to ask about Medicare free drug. Can you talk about the amount of free drug that's being utilized, going into the number? We've heard some discomfort, I would say, from doctors treating Medicare patients with the free drug program that you guys have offered, I guess, just around logistics. And are you satisfied right now with your commercial co-pay program to promote use in the commercial population, just because you guys did say -- I think, Mardi, you said that co-pay utilization was low this quarter.

    恭喜這個季度,但無論如何我還是要抱怨一下。我想問一下關於醫療保險免費藥物的問題。您能談談正在使用的免費藥物的數量嗎?我想說,我們從使用你們提供的免費藥物計劃治療醫療保險患者的醫生那裡聽到了一些不適,我猜,只是圍繞後勤。您現在對促進商業人群使用的商業共同支付計劃感到滿意嗎?

  • Do those two things need to be optimized to set up 2025 to success?

    是否需要優化這兩件事才能讓 2025 年成功?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • First of all, from a free goods perspective, very little this quarter, and there was very little last quarter. That's something that we would expect in time, there's a little bit more utilization of. So not worried at all about where we are. As you're launching any new product as it relates to any of the services that you offer, it takes some time for the community to, a, know exactly what is out there, and then b, how do they utilize those potential offerings. But we're seeing good progress on all those things.

    首先,從免費商品的角度來看,本季很少,上季也很少。這是我們所期望的,會有更多的利用。所以根本不用擔心我們在哪裡。當您推出與您提供的任何服務相關的任何新產品時,社區需要一些時間來:a、確切地了解現有產品;b、他們如何利用這些潛在的產品。但我們看到所有這些事情都取得了良好進展。

  • So we haven't heard that feedback, I have to say. And I spend a lot of time talking with practices. Haven't heard the feedback that it's been a challenge for physicians to access any of the service offerings that we have. But it's certainly something that we keep an eye on. We want to be absolutely best-in-class in this and deliver the best experience that we can for not only the practices, but for the providers.

    所以我不得不說,我們還沒有聽到這樣的回饋。我花了很多時間談論實踐。還沒有聽到回饋說醫生獲得我們提供的任何服務都是一個挑戰。但這肯定是我們密切關注的事情。我們希望在這方面絕對是一流的,並不僅為實踐,而且為提供者提供最佳體驗。

  • Co-pay utilization, we have a very good program where that for commercial patients you would expect that they would pay $10 per month, that we would cover the rest of their obligation. Again, it's pretty early and it's more of an issue of patients making sure they know about it, how to access it, have physicians that are directing them towards it and the practices that are directing them towards it. So we expect that, that is going to increase in time. In fact, we want it to increase in time because we want it to be affordable for patients. And as you recall, what we have emphasized in this launch is affordability for patients.

    共同支付利用,我們有一個非常好的計劃,對於商業患者,您會期望他們每月支付 10 美元,我們將承擔他們的其餘義務。再說一次,現在還很早,更多的是病人確保他們了解它、如何獲得它、有醫生指導他們實現它以及指導他們實現它的實踐的問題。所以我們預計,隨著時間的推移,這個數字將會增加。事實上,我們希望它能及時增加,因為我們希望患者能負擔得起。正如您所記得的,我們在這次發布中強調的是患者的負擔能力。

  • We've done that and we've offered it. The way we've done that is through a very, very robust co-pay assistance program. We do have a PAP program as well. And that's if patients can access drug through any of the other means that are possible for them, we will fulfill that obligation. But we'll keep an eye on any feedback we get.

    我們已經做到了並且我們已經提供了它。我們做到這一點的方式是透過一個非常非常強大的共同支付援助計劃。我們也有 PAP 計劃。也就是說,如果患者可以透過任何其他可能的方式獲得藥物,我們將履行這項義務。但我們會密切注意收到的任何回饋。

  • We react very quickly. And we've said to the community, we've been very clear, if a patient needs the product, we will find a way to help that patient get the product, including it being free product. Equitable access is really important here. We take it really seriously. So we'll keep an eye on it.

    我們反應非常快。我們已經向社區表示,我們非常清楚,如果患者需要該產品,我們將找到一種方法來幫助該患者獲得該產品,包括免費產品。公平的訪問在這裡非常重要。我們非常認真地對待它。所以我們會密切注意。

  • And if you have any specific feedback from where you heard that, we're happy to follow up and talk with them as well.

    如果您從那裡聽到了任何具體反饋,我們也很樂意跟進並與他們交談。

  • Mardi Dier - Chief Financial Officer, Senior Vice President

    Mardi Dier - Chief Financial Officer, Senior Vice President

  • Just Ritu, on what we're seeing from prescription to drug filled, we mentioned that -- it's in the script as well that we've already achieved our goal for the 6-month mark, which was bringing that down from 60 days to 30 days. So things are very much working in the system for us right now.

    Ritu,關於我們從處方到藥物填充的情況,我們提到 - 在劇本中我們已經實現了 6 個月的目標,這將把時間從 60 天縮短到30天。所以現在系統中的一切對我們來說非常有效。

  • Ritu Baral - Analyst

    Ritu Baral - Analyst

  • Good. Wonderful. Thanks.

    好的。精彩的。謝謝。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. Marvin, next question, please.

    偉大的。馬文,請下一個問題。

  • Operator

    Operator

  • John Wolleben, JMP.

    約翰·沃萊本,JMP。

  • Catherine Okoukoni - Analyst

    Catherine Okoukoni - Analyst

  • This is Catherine on for John. I had a question about how payers are currently handling those patients that are already on GLP therapies or want to go on GLP therapies and Rezdiffra. Are you seeing any issues there? And how this informs sort of what will happen if Wegovy is approved for NASH as well?

    這是約翰的凱瑟琳。我有一個問題,關於付款人目前如何處理那些已經接受 GLP 治療或想要繼續接受 GLP 治療和 Rezdiffra 的患者。您看到那裡有什麼問題嗎?如果 Wegovy 也被批准用於 NASH,這將如何告知將會發生什麼?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Yes. So look, I think what we're seeing regarding Wegovy, I believe that about -- from our estimation, about 25% of patients that are on Rezdiffra are also on a GLP-1. And that GLP-1 has been prescribed for a comorbidity, right, and the indications that GLP-1s are indicated for. Now, we've done some market research, which could suggest that up to 50% of patients are either on or have been exposed already to a GLP-1. So we expect to see GLP-1s continue to be used to treat comorbidities.

    是的。所以,我認為我們在 Wegovy 看到的情況,我相信,根據我們的估計,大約 25% 的 Rezdiffra 患者也在服用 GLP-1。GLP-1 已被用於治療合併症,正確的,以及 GLP-1 的適應症。現在,我們已經做了一些市場研究,這可能表明多達 50% 的患者正在服用或已經接觸過 GLP-1。因此,我們預期 GLP-1 會繼續用於治療合併症。

  • And I think as you're getting to kind of the real world here when a physician has a patient who has NASH, they may be on or may have been on a GLP-1, but if they are an F2, F3 patient, they're evaluating if therapy is required to treat that problem. And that's where they're reaching for Rezdiffra regardless of whether the patient has been exposed or not. So how much of a glimpse to the future does that give us? I'm not so sure. But what I would say is that if the market research is correct that 50% of patients are on or have been exposed, they're kind of out there already being used, and there's still a lot of patients with NASH despite the availability of them for many years.

    我認為,當你進入現實世界時,當醫生治療患有 NASH 的患者時,他們可能正在或可能已經正在服用 GLP-1,但如果他們是 F2、F3 患者,他們正在評估是否需要治療來治療該問題。這就是他們要接觸 Rezdiffra 的地方,無論患者是否接觸過病毒。那麼這讓我們對未來有多少了解呢?我不太確定。但我想說的是,如果市場研究是正確的,即 50% 的患者正在使用或已經接觸過,那麼它們就已經被使用了,儘管有它們,但仍然有很多 NASH 患者多年。

  • So we feel like we're in a strong position. And I think that it is two very different things you're evaluating, if you're evaluating somebody for obesity versus you're evaluating somebody for NASH. And we're extremely well positioned for that.

    所以我們覺得自己處於有利地位。我認為,如果你評估某人是否患有肥胖症,與你正在評估某人是否患有 NASH,那麼你正在評估的是兩件截然不同的事情。我們為此做好了充分的準備。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Marvin, next question, please.

    馬文,請下一個問題。

  • Operator

    Operator

  • Andy Chen, Wolfe.

    安迪陳,沃爾夫。

  • Unidentified Participant

    Unidentified Participant

  • This is Emma on for Andy. Congrats on the quarter. Just following up on a question asked about utilization of the free drug program, are you able to provide a split across Bridge versus PAP? And then another question from us, just your recent patient campaign in September raised a lot of awareness. Can you speculate on whether they can be converted to Q4 revenue or Q1 revenue?

    這是艾瑪為安迪配音。恭喜本季。就免費藥物計劃的使用的問題進行跟進,您能否提供 Bridge 與 PAP 之間的區別?然後我們提出另一個問題,你們最近在 9 月開展的患者活動引起了很多人的關注。您能否推測它們是否可以轉換為 Q4 收入或 Q1 收入?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Great. No. Look, with the utilization of Bridge and PAP, so let me just provide a little perspective first. So we do have a Bridge program for commercially insured patients if -- we have the option to send them product in the interim period while their reimbursement is being finalized with the insurer. As I've said in the past, you don't -- you have to decide when you want to use a Bridge program.

    偉大的。不。看,隨著 Bridge 和 PAP 的使用,讓我先提供一點觀點。因此,我們確實為商業保險患者提供了一個過渡計劃,如果——我們可以選擇在過渡期間向他們發送產品,同時他們的報銷正在與保險公司最終確定。正如我過去所說,您不必——您必須決定何時要使用 Bridge 程序。

  • You may not come out of the gates using one. In this case, since there's such assurance now of a path to reimbursement with 80% of commercial lives covered, it is a good time to have a Bridge program. And this way, we don't want to have a patient delayed in getting product while insurance is being worked out. So we have offered to patients the ability to start while insurance is being worked out. And there's utilization of that program.

    您可能無法使用它走出大門。在這種情況下,由於現在有這樣的保證,可以保證 80% 的商業壽命得到報銷,因此現在是實施橋樑計劃的好時機。這樣,我們就不希望患者在製定保險時延遲獲得產品。因此,我們為患者提供了在製定保險期間開始的能力。並且有對該程序的利用。

  • I wouldn't call it broad at this point. From a free goods perspective, again, we said there were very few free goods patients in the quarter, and that's similar to what we said last quarter, very few free good patients. So to me, that's an indicator that coverage is very strong and that patients are finding a path to product without relying on PAP. However, it is available. People are using it.

    在這一點上我不會稱其為廣泛的。從免費商品的角度來看,我們再次表示,本季免費商品患者很少,這與我們上季度所說的類似,免費的好患者很少。所以對我來說,這表明覆蓋範圍非常強大,並且患者正在尋找不依賴 PAP 的產品途徑。然而,它是可用的。人們正在使用它。

  • And we would expect in time that, that number is going to increase. But let me be clear about the patients that we have on. This is a really strong demand quarter. There's very few free patients, and we're really, really excited about it. Now, you asked the question about some of the patient work that's been done, the patient campaign and how there seems to be a lot of interest.

    我們預計,隨著時間的推移,這個數字將會增加。但讓我澄清一下我們所接受的患者。這是一個需求非常強勁的季度。免費病人很少,我們對此感到非常非常興奮。現在,你問了一些關於已經完成的耐心工作、耐心活動以及似乎有很多興趣的問題。

  • Will that ultimately turn into Q4? A lot of what you have to do in a launch is drive awareness. It's the first step to patients taking action or physicians being comfortable and knowledgeable and ultimately taking action. So yes, we did see -- we have seen so far a positive response to our efforts to directly reach out to patients with our DTC efforts. How much of that translates into future demand?

    最終會變成第四季嗎?在發布過程中你要做的很多事情就是提高意識。這是患者採取行動或醫生感到舒適和知識淵博並最終採取行動的第一步。所以,是的,我們確實看到了——到目前為止,我們已經看到我們透過 DTC 直接接觸患者的努力得到了積極的回應。其中有多少轉化為未來的需求?

  • Well, our hope, obviously, is that it plays a role in it, but in itself, it is a piece of it. You still need to have the practices ready, that they have their pathway to bring patients through and along through everything from diagnosis through to prescription and fulfillment of prescription and follow-up. So it's an important component, but I would consider it a piece of the full effort that we're making rather than a stand-alone.

    嗯,顯然,我們的希望是它在其中發揮作用,但就其本身而言,它是其中的一部分。您仍然需要準備好實踐,他們有自己的途徑來帶領患者完成從診斷到處方、履行處方和隨訪的所有過程。所以它是一個重要的組成部分,但我認為它是我們正在做出的全部努力的一部分,而不是一個獨立的部分。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Marvin, next question, please.

    馬文,請下一個問題。

  • Operator

    Operator

  • Prakhar Agrawal, Cantor Fitzgerald.

    普拉哈·阿格拉沃爾,坎托·菲茨杰拉德。

  • Prakhar Agrawal - Analyst

    Prakhar Agrawal - Analyst

  • Prakhar here from Cantor. Congrats on the great quarter. So maybe my first question is, if you can comment on the month-over-month patient adds seen in 3Q? And whether you saw a lot of adds in July and more steadier adds in August, September? The reason I'm asking is a linear patient add in 3Q would imply a lower sales number assuming inventory is at the low end.

    普拉哈爾從康託來。恭喜這個偉大的季度。所以也許我的第一個問題是,您是否可以對第三季逐月增加的患者數量發表評論?您是否在 7 月看到了許多新增內容,並在 8 月、9 月看到了更穩定的新增內容?我問的原因是,假設庫存處於低端,第三季度的線性患者增加將意味著銷售額較低。

  • So just trying to reconcile the patient growth seen throughout 3Q and the revenue number. And as a follow-up, would you expect similar sequential growth on new patient adds in 4Q? Or would there be some moderation given the month-on-month trends seen in 3Q? Congrats again.

    因此,我們只是試圖協調整個第三季的患者成長和收入數字。作為後續行動,您是否預期第四季新增病患數量會出現類似的連續成長?或者考慮到第三季的環比趨勢,是否會出現一些放緩?再次恭喜。

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Look, we're steadily adding patients and prescribers, and that continued pretty consistently through the summer and even as we look ahead to October. We're very pleased with the uptake. And really, it's each day, each week, each month we're adding and you get the cumulative effect of that. So not giving -- I'm not going to give specifics on a per month because it can be a little noisy from a month-to-month. We're looking at it from a quarter perspective.

    看,我們正在穩步增加患者和處方者,並且這種情況在整個夏天甚至在我們展望十月時都持續保持。我們對採用情況感到非常滿意。事實上,我們每天、每週、每個月都在添加,你就會得到累積的效果。所以不提供——我不會提供每月的具體信息,因為每個月的情況可能會有點吵。我們從季度的角度來看它。

  • And what you're seeing is the cumulative effect of all those things make for really strong quarterly growth. So that's what we had in the third quarter. And as we move into the fourth quarter, the dynamics remain.

    您所看到的是所有這些因素的累積效應帶來了真正強勁的季度成長。這就是我們第三季的情況。當我們進入第四季時,動態依然存在。

  • Mardi Dier - Chief Financial Officer, Senior Vice President

    Mardi Dier - Chief Financial Officer, Senior Vice President

  • Yes. And Prakhar, I would just add that Bill addressed the fourth quarter during the script, if you want to go back and listen to that.

    是的。普拉哈爾,如果你想回去聽聽的話,我想補充一下,比爾在劇本中談到了第四季的內容。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. All right. Marvin, next question, please.

    偉大的。好的。馬文,請下一個問題。

  • Operator

    Operator

  • Andrea Newkirk, Goldman Sachs.

    安德里亞·紐柯克,高盛。

  • Andrea Newkirk - Analyst

    Andrea Newkirk - Analyst

  • Congratulations on the quarter. Bill, you've mentioned this or maybe referred to this a couple of times here. But in terms of the specialty drug analogs or benchmarks that you're looking at, wondering if you're willing to maybe provide a little bit more specifics there as to which one specifically as we think about the forward trajectory? And then would love an update here on how uptake has been going across your hepatologists versus your gastroenterologists. I know last quarter, the latter had been a key point of focus as they are the majority of the prescribers here.

    恭喜本季。比爾,您已經提到過這一點,或者可能在這裡多次提到這一點。但就您正在關注的特種藥物類似物或基準而言,想知道您是否願意提供更多具體信息,說明我們在考慮未來發展軌跡時具體是哪一個?然後我希望在這裡了解您的肝病專家與胃腸病專家的最新情況。我知道上個季度,後者一直是焦點,因為他們是這裡的大多數處方者。

  • But how has that been going?

    但進展如何呢?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • So look, these are -- the group of around 10 over the last 10 years that I mentioned, these are all blockbuster specialty medicines. They tend to be first-in-class, first-in-disease medicines in high unmet need areas. That's about all we'll give for now. But look, I think you can see with our results, strong results, and we say that we are performing well against the benchmarks and our own internal metrics. I think we picked the right -- I think we picked the right comparators.

    所以你看,這些是我提到的過去 10 年裡大約 10 種藥物,這些都是重磅炸彈特種藥物。它們往往是需求未被滿足的領域中的一流、首創疾病藥物。這就是我們現在所能提供的一切。但是看,我想你可以從我們的結果中看到,強勁的結果,我們說我們根據基準和我們自己的內部指標表現良好。我認為我們選擇了正確的比較器。

  • And I think that we're really holding a high bar for ourselves. The team that we brought on board is not here for a hobby. They're here to win. They're here to create a market and have a product, being Rezdiffra, be looked at as amongst one of the best launches in the industry. So we have our goal set really, really high.

    我認為我們確實為自己設定了很高的標準。我們引進的團隊並不是為了嗜好而來到這裡的。他們來這裡是為了勝利。他們來這裡是為了創造一個市場,並推出一款產品,即 Rezdiffra,被視為業內最好的產品之一。所以我們的目標設定得非常非常高。

  • And the team, as you can see, I think has done a remarkable job, especially if you think about where we were 12 months ago -- well, actually, where we were in January, which isn't even 12 months ago when we had not even a commercial team in place of significance, and what we've been able to do in that short period of time. So I have to say I've been involved in a lot of launches, been involved in a lot of outstanding launches. We're doing a great job with this launch. I put this one at the top of the pile. So just a little bit of commentary there.

    正如你所看到的,我認為這個團隊做得非常出色,特別是如果你想想我們12 個月前的情況——嗯,實際上,我們在一月份的情況,那甚至還不到12 個月前,當時我們甚至沒有一個具有重要意義的商業團隊,以及我們在這麼短的時間內所能做的事情。所以我不得不說我參與了很多發布,並參與了很多出色的發布。我們在這次發布中做得很好。我把這個放在最上面。所以這裡只做一點評論。

  • So a little bit about heps and GIs. I would say similar to what I said in the last quarter, but obviously progress by both groups. If you think about the 14,000 physicians that we're targeting, 6,000 is really the key. There's under a thousand hepatologists in the country. So by virtue of where the numbers are per se of patients, just by a sheer volume of physicians, you've got a lot more gastroenterologists than you do hepatologists.

    關於 heps 和 GI 的一些知識。我想說的與我在上個季度所說的類似,但顯然兩組都取得了進展。如果您考慮我們的目標 14,000 名醫生,那麼 6,000 名醫生確實是關鍵。全國有不到千名肝病專家。因此,根據患者數量本身,以及醫生的絕對數量,胃腸病學家比肝病學家多得多。

  • And what we've seen is kind of steady growth in breadth and depth across both the groups. Now remember, the hepatologists, they are liver doctors. That is their organ of specialty. So they're a little bit earlier, moving a little bit faster, I would say, on average because they knew the disease, they've been looking at the liver for a long time, and off to a little bit faster start. However, the GIs represent and will represent the majority, overwhelming majority of the scripts just based on the sheer number of them.

    我們看到這兩個群體的廣度和深度都在穩定成長。現在請記住,肝臟科醫生,他們是肝臟醫生。那是他們的專業器官。所以我想說,他們平均起來要早一點,行動要快一點,因為他們了解這種疾病,他們已經研究肝臟很久了,而且開始得更快一點。然而,僅從數量上來看,地理標誌代表了並將代表大多數、絕大多數的文字。

  • And they're making progress. Now, they had to start from a little bit different space though, right? They didn't have pathways established in their practices for how to process NASH patients, let alone treat NASH patients. Somewhere -- and the ones that we're focused on in that target 6,000 are interested in NASH, interested in the liver. That's how we've enriched that target population or target group of prescribers.

    他們正在取得進展。現在,他們必須從一個稍微不同的空間開始,對吧?他們沒有在實踐中建立如何處理 NASH 患者的途徑,更不用說治療 NASH 患者了。在某個地方——我們在 6,000 名目標中重點關注的人對 NASH 感興趣,對肝臟感興趣。這就是我們豐富目標族群或目標處方者群體的方式。

  • They have taken steps to create these pathways. Now, I'll just give two points in time. A year ago, there was the ACG, American College of Gastroenterology, meeting in Vancouver. And last week or beginning of this week, the meeting was in Philadelphia, gastroenterology meeting. And it was like a night and day difference.

    他們已採取措施創建這些途徑。現在,我只給兩個時間點。一年前,ACG(美國胃腸病學會)在溫哥華舉行了會議。上週或本周初,會議是在費城舉行的胃腸病學會議。這就像是白天和黑夜的區別。

  • People knew the drug, people were taking steps to create pathways. People were hiring staff to help process their NASH treatment in the form of APPs, et cetera, and taking steps to acquire imaging equipment. So that wasn't categorically across everyone, but you have the whole gastroenterology target group which is moving towards creating these pathways and so forth. So where we are in launch at seven months out or so, it's remarkable how quickly people are shifting towards -- really, I would say, creating their pathway in each of their practices for how to process a NASH patient. And it just -- it's taken some time, but it's really happening quickly.

    人們知道這種藥物,人們正在採取措施創造途徑。人們僱用員工以 APP 等形式幫助處理 NASH 治療,並採取措施購買影像設備。因此,這並不是絕對適用於每個人,但整個胃腸病學目標群體正在努力創建這些途徑等等。因此,我們在七個月左右的時間裡推出,值得注意的是,人們的轉變速度有多快——實際上,我想說的是,在他們的每項實踐中為如何治療NASH 患者創建自己的途徑。這只是——這花了一些時間,但它確實發生得很快。

  • They understand the unmet need. They're happy to see that there's now a foundational therapy that's available that's pretty easy to use, right? So that gives you a little bit more color around it. But heps still ahead of GIs just because I think of their training, their knowledge of the space. But GIs are moving along really quickly, and we're going to be relying on them heavily throughout the future.

    他們了解未滿足的需求。他們很高興看到現在有一種非常容易使用的基礎療法,對吧?這樣你的周圍就會多一點顏色。但他仍然領先美國士兵,只是因為我想到了他們的訓練和他們對太空的了解。但大兵的發展速度非常快,我們在未來將嚴重依賴它們。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. Marvin, next question, please.

    偉大的。馬文,請下一個問題。

  • Operator

    Operator

  • Liisa Bayko, Evercore.

    莉莎·貝科,Evercore。

  • Liisa Bayko - Analyst

    Liisa Bayko - Analyst

  • I have sort of two types of questions. One is US based and one Europe. So for US-related question, can you give us a little more color on the gross to net? Mardi, I know you said it was favorable and would be choppy, but where did we land this quarter?

    我有兩種類型的問題。一間位於美國,一間位於歐洲。那麼,對於與美國相關的問題,您能給我們更多關於淨值的資訊嗎?Mardi,我知道你說過這是有利的並且會波動,但是我們這個季度的著陸點在哪裡?

  • Any color on sort of discontinuation rate thus far that you're seeing? And then as you think about semaglutide and assuming that data is positive, do you expect any changes in gross to net as a result of that? And then for Europe, could you give us kind of a lens on -- from the same kind of way you looked at the US market, you had kind of diagnosed patients and then the ones with significant fibrosis in care. Could you provide those kind of numbers for Europe?

    到目前為止,您看到的停藥率有什麼顏色嗎?然後,當您考慮索馬魯肽並假設數據是正面的時,您預計總淨值會因此發生任何變化嗎?然後對於歐洲,您能否給我們一個鏡頭——就像您觀察美國市場的方式一樣,您有一些已確診的患者,然後是那些患有嚴重纖維化的患者正在接受護理。您能提供歐洲的此類數字嗎?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Okay. Great. Maybe what I'll do is, let me start with Europe and then we'll move on back to the gross to net. Europe is -- it's kind of interesting. Europe, I would say, is ahead of the US.

    好的。偉大的。也許我要做的是,讓我從歐洲開始,然後我們再回到淨值。歐洲有點有趣。我想說,歐洲領先美國。

  • versus where we were a year ago. They've had the benefit of knowing that a product was approved for NASH. And as a result, they're planning for success that the product will get approved in Europe. And so they're taking more action. As I said over the past calls and in meetings, that when physicians told us here that they hadn't really taken steps in advance of approval to kind of wire their system, so to speak, they meant it.

    與一年前相比。他們受益匪淺,因為他們知道某個產品已被批准用於治療 NASH。因此,他們正在計劃成功讓該產品在歐洲獲得批准。因此他們正在採取更多行動。正如我在過去的電話和會議中所說,當醫生在這裡告訴我們他們並沒有真正在批准之前採取措施來連接他們的系統時,可以這麼說,他們是認真的。

  • I mean, with the exception of a few practices, it wasn't until March 14 that they started thinking about how they're going to process patients. Now, Europe is a little bit different in that they see the success in the US of an approval, they plan for it. And I think the first indicator of that was the EASL guidelines that came out essentially a year plus in advance of approval, anticipating that if approved, Rezdiffra, this is how it would fit into the treatment regimen. So we feel that they're really in good shape.

    我的意思是,除了少數做法外,直到 3 月 14 日,他們才開始考慮如何處理患者。現在,歐洲有點不同,他們看到了美國批准的成功,並為此做好了計劃。我認為第一個指標是 EASL 指南,該指南基本上在批准前一年多就發布了,預計如果獲得批准,Rezdiffra,這就是它將如何適應治療方案。所以我們覺得他們的狀態真的很好。

  • Now look, we're getting started a little bit later, obviously, in Europe than we did in the US. We've had a medical team that's been over there for years now, but we are just starting those efforts. And we're going to do it in a very, very targeted way. The reason that we're going is NASH is prevalent in Europe and there's patient numbers there that we think are -- approximate the US opportunity from the number of F2, F3 patients that are most in need.

    現在看,我們在歐洲的起步顯然比在美國晚一些。我們的醫療團隊已經在那裡工作多年,但我們才剛開始這些努力。我們將以非常非常有針對性的方式來做這件事。我們這樣做的原因是 NASH 在歐洲很流行,我們認為那裡的患者數量與美國最需要的 F2、F3 患者數量大致相同。

  • As we get closer to launch, we're going to come back and give a little bit more of an assessment of what do patient numbers look like, exactly who the targets are, et cetera, and be able to give you a little bit better idea. We're well on the way. We're hiring leadership, but we're doing so in a very, very focused, diligent manner. We are planning for success. We think that Europe still will recognize value.

    隨著我們越來越接近發布,我們將回來對患者數量、目標到底是誰等進行更多評估,並能夠為您提供更好的幫助主意。我們一切順利。我們正在招募領導階層,但我們的招募方式非常非常專注、勤奮。我們正在為成功做好計劃。我們認為歐洲仍然會認識到價值。

  • We've seen that in other launches. When I say -- they recognize innovation. So that's how we're progressing there. That's why we're going there. So maybe, Mardi, do you want to pick up the US.

    我們在其他發布中已經看到了這一點。當我說——他們認可創新。這就是我們進展的方式。這就是我們要去那裡的原因。那麼,Mardi,你想選擇美國嗎?

  • gross to net?

    毛淨額?

  • Mardi Dier - Chief Financial Officer, Senior Vice President

    Mardi Dier - Chief Financial Officer, Senior Vice President

  • Yes, absolutely. And you're right, gross to net can be choppy, particularly in these early quarters of launch. And as we look forward for gross to net, we do expect some additional impacts, as we've already said. So one of the biggest factors in our gross to net right now is the co-pay assistance program. And we said that, that was slightly lower again this quarter than our own expectations.

    是的,絕對是。你是對的,毛淨值可能會不穩定,尤其是在發布的早期幾個季度。正如我們已經說過的,當我們展望總淨值時,我們確實預期會產生一些額外的影響。因此,目前影響我們總淨值的最大因素之一是共同支付援助計劃。我們說過,本季這數字再次略低於我們自己的預期。

  • And we do want that to grow, as Bill already described. We think that benefits the patients and keeps more patients on drug looking forward. So we will see some growth there on the co-pay assistance. I can't comment on 2025, of course. And we anticipate that we'll see a typical Q1 dynamics with gross to net, including insurance reops, plan changes, et cetera.

    正如比爾已經描述的那樣,我們確實希望這種增長。我們認為這對患者有利,並讓更多患者對藥物充滿期待。因此,我們將看到共同支付援助有所增長。當然,我無法對 2025 年發表評論。我們預計,我們將看到典型的第一季整體動態與淨值動態,包括保險報告、計畫變更等。

  • So we -- like other pharma companies, we expect an impact from the IRA as well in that Q1 2025 gross to net. So bottom line, gross to net will step up in Q1 2025, but still within the range of like specialty medicines. And just to answer your question specifically about sema and the potential impact on gross to net if sema is approved in NASH, I'll go back and say that we really believe that our gross to net will stay within the range that is typical for specialty medicines.

    因此,與其他製藥公司一樣,我們預計 IRA 也會對 2025 年第一季的毛淨額產生影響。因此,總的來看,2025 年第一季的毛淨值將會上升,但仍處於類似特種藥物的範圍內。And just to answer your question specifically about sema and the potential impact on gross to net if sema is approved in NASH, I'll go back and say that we really believe that our gross to net will stay within the range that is typical for specialty藥物.

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • And maybe, Liisa, asked a question about persistency and discontinuations. Look, it's still pretty early, but everything that we're seeing so far gives us a reason to believe that persistency is going to be strong for this product. It will tend to look like good oral persistency. The one thing, again -- discontinuations, yes, there have been discontinuations like you would with any product have some. And that's -- we're presenting the net number of patients that were on drug at the end of the quarter, the 6,800 -- over 6,800, right?

    也許,莉莎問了一個關於堅持和中斷的問題。看,現在還很早,但到目前為止我們所看到的一切都讓我們有理由相信這個產品的持久性將會很強。它往往看起來像是良好的口腔持久性。再次強調一件事——停產,是的,就像任何產品都會有的停產一樣。那就是——我們呈現的是本季末接受藥物治療的患者淨人數,即 6,800 人——超過 6,800 人,對吧?

  • So that's net of everything. But we're really optimistic. We think -- we saw in the clinical trials discontinuation was really low. And we really think persistency is going to be strong with this. It's a strong profile drug.

    所以這就是一切的淨值。但我們真的很樂觀。我們認為,我們在臨床試驗中看到,停藥率確實很低。我們確實認為這樣做的毅力會很強。這是一種強效藥物。

  • I mean, you've heard me say in the past like this is -- in kind of my career, this is kind of a Holy Grail profile. Everyone wants a pill once a day -- that's once a day. And we've had patients say that hearing there was this solution beyond anything gave them hope that there was a path forward. And we've heard that from a number of patients. And we think that, that in itself is a really good sign.

    我的意思是,你過去聽過我這樣說——在我的職業生涯中,這是一種聖杯形象。每個人都想要每天吃一次藥——那就是每天一次。我們的病人說,聽到這個解決方案超出了任何事情,讓他們希望有一條前進的道路。我們從許多患者那裡聽到了這樣的說法。我們認為,這本身就是一個非常好的跡象。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Marvin, next question, please. We'll try to get a couple more in.

    馬文,請下一個問題。我們會嘗試讓更多人加入。

  • Operator

    Operator

  • Jay Olson, Oppenheimer.

    傑·奧爾森,奧本海默。

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Congrats on all the progress. Can you talk about the event rate in MAESTRO-NASH? And how is that rate tracking versus your expectations? And the importance of fibrosis improvement for driving a clinical outcomes benefit for Rezdiffra? And then also your expectations for the fibrosis improvement endpoint in the ESSENCE trial?

    祝賀所有的進展。您能談談 MAESTRO-NASH 中的事件發生率嗎?利率追蹤與您的預期相比如何?纖維化改善對於推動 Rezdiffra 臨床結果效益有何重要性?那麼您對 ESSENCE 試驗中纖維化改善終點的期望是什麼?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • There's a lot there to try to answer. Let me start with ESSENCE, I'll work backwards. We're not sure. We haven't seen the data. We don't know.

    有很多東西需要嘗試回答。讓我從 ESSENCE 開始,我會倒著做。我們不確定。我們還沒有看到數據。我們不知道。

  • As I said, there's a few questions that we're going to want to understand. Top line results, as I said, don't always translate into labels very well. There's the, what do you present versus what's the regulatory standard you're going to be held to when it becomes labeling? So we'll ask, what the intent-to-treat population look like? How are discontinuations categorized or handled?

    正如我所說,我們需要了解一些問題。正如我所說,最重要的結果並不總是能很好地轉化為標籤。還有,當它成為標籤時,你會提出什麼,以及你要遵守的監管標準是什麼?所以我們會問,意向治療人群是什麼樣的?如何對停產進行分類或處理?

  • And also what happens from a dosing perspective? How many patients got to the top dose? Not sure what it's going to look like, right? So I think we hear that it's going to be in the coming weeks anyways that we get an answer. So look, regardless of what the results show, we're in a really strong position.

    從劑量角度來看會發生什麼事?有多少患者接受了最高劑量?不確定它會是什麼樣子,對吧?所以我想我們聽說無論如何我們都會在未來幾週內得到答案。所以看,無論結果如何,我們都處於非常有利的位置。

  • We have just a product profile -- as I said, a very strong product profile. We've got a lot of patients that are on drug. We've got a lot of physicians that are using the drug. And that momentum is picking up. So regardless of how it looks, we feel like we're in a strong space.

    我們只有一個產品簡介——正如我所說,一個非常強大的產品簡介。我們有很多正在服用藥物的患者。我們有很多醫生正在使用這種藥物。而且這種勢頭正在增強。因此,無論看起來如何,我們都感覺自己處於一個強大的空間。

  • And as we talked about on the call, we know that there's going to be a real effort by any new entrant to try to drive the size of the market and number of patients that are prescribed and so forth. And we're in a position to benefit from that as well. Regarding the other -- our trials that are ongoing, we haven't commented. And we're not going to be able to comment on what event rates look like. This is an ongoing trial, and we will continue to monitor.

    正如我們在電話中談到的那樣,我們知道任何新進入者都將做出真正的努力來擴大市場規模和處方患者數量等。我們也能夠從中受益。關於我們正在進行的試驗,我們還沒有發表評論。我們無法評論事件發生率。這是一項正在進行的試驗,我們將繼續監測。

  • Part of -- if you think about the OUTCOMES trial, and I'm saying the psoriasis -- pardon me, psoriasis -- cirrhosis outcomes -- old habit -- the cirrhosis OUTCOMES trial, we had to think about what would event rates look like. And since this is really not so well an understood population, we used the best measures that we could around us to try to understand what that would look like. And as I said, I think this trial is going to really help educate the community on that cirrhosis population about what event rates do look like and so forth. So we're anxiously awaiting. As we have more data, we'll obviously -- when I say data, we're not going to give a running update of the trial, but we're -- now that we're fully enrolled, we're excited to be monitoring the trial and seeing what the outcomes look like in that '27 time frame.

    如果你考慮一下 OUTCOMES 試驗,我說的是牛皮癬 - 對不起,牛皮癬 - 肝硬化結果 - 舊習慣 - 肝硬化 OUTCOMES 試驗,我們必須考慮事件發生率會是什麼樣子。由於這確實不是一個很好理解的人群,因此我們使用了周圍可以使用的最佳措施來嘗試了解它會是什麼樣子。正如我所說,我認為這項試驗將真正幫助社區了解肝硬化族群的事件發生率等等。所以我們焦急地等待著。隨著我們擁有更多數據,我們顯然 - 當我說數據時,我們不會提供試驗的運行更新,但我們 - 現在我們已經完全註冊,我們很高興正在監控試驗並查看27 年時間範圍內的結果。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. Marvin, time for one more question, please, if you could queue for that.

    偉大的。馬文,請再問一個問題,如果您可以排隊的話。

  • Operator

    Operator

  • Thomas Smith, Leerink Partners.

    托馬斯史密斯,Leerink 合夥人。

  • Thomas Smith - Analyst

    Thomas Smith - Analyst

  • Let me add my congrats on the nice launch quarter. I wanted to ask whether you have any visibility into early patient persistence and refill rates. I know it's still early days, but you're clearly continuing to drive new patient adds. And I'm just wondering if you're able to put any numbers around persistence or if you have a sense of when you'll be able to quantify that? And then just separately with respect to business development, having brought Dr.

    讓我對美好的發布季度表示祝賀。我想問您是否了解早期患者的堅持和補充率。我知道現在還為時過早,但您顯然正在繼續推動新患者的增加。我只是想知道你是否能夠給出關於持久性的任何數字,或者你是否知道什麼時候能夠量化它?然後就業務發展而言,分別帶來了博士。

  • Charlton on board, I think, is pretty notable. Could you just speak to how you're thinking about BD from here and potentially building out a pipeline beyond Rezdiffra? Any preference on stage of development as you're potentially evaluating some of those opportunities?

    我認為查爾頓的加入非常引人注目。您能否談談您對 BD 的看法以及是否有可能在 Rezdiffra 之外建立一條管道?當您可能評估其中一些機會時,對發展階段有什麼偏好嗎?

  • Bill Sibold - Chief Executive Officer

    Bill Sibold - Chief Executive Officer

  • Yes, with persistence, as we've said a little bit earlier, it's early. We're only seven months or so into the launch. But what we've seen so far, we're optimistic about. I think we need to get past the 12-month mark to be able to at least start looking at cohorts. And even then, as you know, with the growing number of patients, even from the beginning, there's going to be very few that have been on for 12 months at the 12-month mark.

    是的,只要堅持,正如我們之前所說的,現在還早。我們距離發布僅七個月左右。但到目前為止,我們對所看到的情況感到樂觀。我認為我們需要超過 12 個月的時間才能至少開始研究同類人群。即便如此,如您所知,隨著患者數量的不斷增加,即使從一開始,也很少有患者能在 12 個月的時間裡堅持使用 12 個月。

  • It's kind of you've got to get to the 18 months to have enough of a sample of patients to really be able to say. But we're really optimistic about it based on clinical trials and what we're seeing in the real world already. From a BD perspective -- look, what we've said is we want to build a pipeline and our focus is really in NASH. And what are we looking at? Hey, we look at everything.

    你必須在 18 個月內獲得足夠的患者樣本才能真正做出判斷。但根據臨床試驗和我們在現實世界中所看到的情況,我們對此非常樂觀。從 BD 的角度來看,我們所說的是我們想要建立一個管道,我們的重點實際上是 NASH。我們在看什麼?嘿,我們看看一切。

  • And one of the things that I think is always a measure of leadership in a space is inbound calls that you get about people wanting to talk to you because you are the leader. And that's clearly something that we're experiencing already. I think anyone who has a NASH product that they're looking at and has an interest in partnership and so forth is certainly going to reach out to us. From a stage perspective, we'll look across the gamut. We have the advantage.

    我認為衡量一個領域領導的標準之一就是你接到的電話,因為你是領導者,人們想與你交談。這顯然是我們已經經歷過的事情。我認為任何擁有正在關注的 NASH 產品並對合作夥伴感興趣等的人肯定會與我們聯繫。從舞台的角度來看,我們將放眼整個領域。我們有優勢。

  • We're in a leadership position now. We have what we believe is the foundational therapy with Rezdiffra. Rezdiffra alone is a fantastic product. But we are going to look for opportunities of next best mechanism of action or what would potentially be a good combination, et cetera. And we have deep, deep, deep experience in this space.

    我們現在處於領先地位。我們認為 Rezdiffra 是基礎療法。Rezdiffra 本身就是一個很棒的產品。但我們將尋找下一個最佳行動機制的機會,或者可能是一個好的組合,等等。我們在這個領域有很深很深的經驗。

  • So we feel like we're in a good position to make the call of what would be the right product to add to the portfolio, product or products. And we're going to do so in a very thoughtful way and make sure we pick something that truly is the right thing for us. So we'll continue to evaluate. And when we see something that's right, that is actionable, then we'll consider moving forward with that. But let me just be perfectly clear what our stated intent is, is to be the leading NASH company in the industry, period, that has a short, medium and long term side to it.

    因此,我們覺得我們處於一個有利的位置,可以決定將什麼產品添加到投資組合、一個或多個產品中。我們將以一種非常深思熟慮的方式這樣做,並確保我們選擇真正適合我們的東西。所以我們會繼續評估。當我們看到一些正確的、可行的事情時,我們會考慮繼續前進。但讓我完全清楚我們的既定意圖是什麼,是成為業界領先的 NASH 公司,具有短期、中期和長期的方面。

  • And we feel we're well underway, especially when you see how strong a start we are off to.

    我們感覺我們進展順利,尤其是當你看到我們有多麼強勁的開局時。

  • Tina Ventura - Chief Investor Relations Officer

    Tina Ventura - Chief Investor Relations Officer

  • Great. Thanks, Bill. And thank you all for your time today and your interest. We're going to conclude the call. A replay of this webcast will be available on our website in about two hours.

    偉大的。謝謝,比爾。感謝大家今天抽出寶貴的時間和興趣。我們將結束通話。這個網路廣播的重播將在大約兩個小時後在我們的網站上提供。

  • So thank you for joining us.

    感謝您加入我們。

  • Operator

    Operator

  • Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect. Have a wonderful day.

    女士們、先生們,感謝你們參加今天的會議。您現在可以斷開連線。祝你有美好的一天。