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Operator
Operator
Good morning, and thank you for standing by. Welcome to Madrigal Pharmaceuticals second quarter 2025 earnings conference call.
早安,感謝您的支持。歡迎參加 Madrigal Pharmaceuticals 2025 年第二季財報電話會議。
(Operator Instructions) As a reminder, today's conference call is being recorded.
(操作員指示)提醒一下,今天的電話會議正在被錄音。
I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.
現在我想介紹首席投資者關係官蒂娜·文圖拉女士。請繼續。
Tina Ventura - Chief Investor Relations
Tina Ventura - Chief Investor Relations
Thank you, Demi. Good morning, everyone, and thank you for joining us to discuss Madrigal's second quarter 2025 earnings. We issued a press release this morning and posted a slide deck that accompanies this webcast on the Investor Relations section of our website.
謝謝你,黛咪。大家早安,感謝您加入我們討論 Madrigal 2025 年第二季的收益。我們今天早上發布了一份新聞稿,並在我們網站的投資者關係部分發布了與本次網路廣播配套的幻燈片。
On the call with me today is Bill Sibold, Chief Executive Officer; Dave Soergel, Chief Medical Officer; and Mardi Dier, Chief Financial Officer. They'll provide prepared remarks, and then we'll take your questions.
今天與我一起通話的有執行長比爾·西博爾德 (Bill Sibold)、首席醫療官戴夫·索格爾 (Dave Soergel) 和首席財務官馬迪·迪爾 (Mardi Dier)。他們會提供準備好的發言,然後我們會回答您的問題。
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.
請注意,在第 2 張投影片上,我們今天將做出某些前瞻性陳述。我們請您參閱我們向美國證券交易委員會提交的文件,以了解可能導致實際結果與前瞻性陳述不同的風險。
And with that, I will now turn the call over to Bill.
現在,我將把電話轉給比爾。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Thanks, Tina. Good morning, and thanks for joining us. We have a lot to cover today. Before we move into this quarter's performance, as you can see on slide 3, it's been an incredibly exciting and productive last few months at Madrigal both driving the launch and building our future. We've accomplished a lot, and each of these milestones reflect the deliberate execution of our long-term strategy to maximize Rezdiffra's value and expand our leadership in MASH.
謝謝,蒂娜。早安,感謝您加入我們。今天我們有很多內容要講。在我們介紹本季的業績之前,正如您在幻燈片 3 中看到的,Madrigal 過去幾個月經歷了令人難以置信的激動人心和富有成效的時期,既推動了產品的發布,也構建了我們的未來。我們已經取得了許多成就,每一個里程碑都反映了我們長期策略的刻意執行,即最大限度地提高 Rezdiffra 的價值並擴大我們在 MASH 中的領導地位。
In a short time, we've transformed Madrigal into a company with a longer runway, a stronger foundation and greater flexibility to build for the future. Fundamental to our success is our business in the US, which continues to outperform. Rezdiffra's quarterly run rate now exceeds $200 million, well on its way to blockbuster status.
在短時間內,我們已將 Madrigal 轉變為一家擁有更長跑道、更強大基礎和更大靈活性以面向未來的公司。我們成功的根本原因是我們在美國的業務持續表現出色。Rezdiffra 的季度營業額目前已超過 2 億美元,預計將成為一部賣座影片。
We can objectively say it stands among the best specialty launches of the last decade. Second, we strengthened the long-term value of Rezdiffra with our new US patent providing protection to February 2045. This changes how we think about Rezdiffra's growth potential and our investment in the business. It's not about years of opportunity but decades.
我們可以客觀地說,它是過去十年來最好的特色產品之一。其次,我們透過新的美國專利加強了 Rezdiffra 的長期價值,該專利的保護期至 2045 年 2 月。這改變了我們對 Rezdiffra 的成長潛力以及我們對該業務的投資的看法。這不是幾年的機遇,而是幾十年的機會。
Third, we're preparing to expand internationally, beginning with Germany later this year. Geographic expansion adds another potential future growth opportunity for Rezdiffra. Fourth, we're working to expand Rezdiffra with an indication in compensated MASH cirrhosis or F4c, where our outcomes trial continues to progress, if positive, it could double Rezdiffra market opportunity.
第三,我們正準備向國際擴張,今年稍後將從德國開始。地理擴張為 Rezdiffra 增加了另一個潛在的未來成長機會。第四,我們正在努力擴大 Rezdiffra 在代償性 MASH 肝硬化或 F4c 中的適應症,我們的結果試驗正在繼續進展,如果結果呈陽性,它可能會使 Rezdiffra 的市場機會翻倍。
And finally, we're building a pipeline for the next phase of leadership in MASH. With the addition of a promising oral GLP-1 to combine with Rezdiffra. And we have the capital in place that will allow us to support and scale all of this. Each of these pieces add value to the foundation we are building for long-term leadership in MASH.
最後,我們正在為 MASH 的下一階段領導層建立人才梯隊。加入有前景的口服 GLP-1 與 Rezdiffra 結合。我們擁有足夠的資金來支持和擴大這一切。上述每一部分都為我們在 MASH 長期領導地位奠定的基礎增添了價值。
So let's move into the call with our agenda on slide 4. A lot has happened since our last call. I wanted to take the opportunity first to talk about the new US patent that was issued today. We believe it's a significant contributor to our long-term outlook.
那麼讓我們按照幻燈片 4 上的議程開始通話。自從我們上次通話以來發生了很多事。我想先藉此機會談談今天頒發的美國新專利。我們相信它對我們的長期前景有重大貢獻。
As we summarize on slide 5, the patent covers claims directed to Rezdiffra commercial weight threshold dosing regimen as prescribed in its FDA-approved label and will be listed in the FDA Orange book. And we recently learned some favorable news. The patent reflects an updated expiration date of February 4, 2045, which is extended from the previously noted date of September 30, 2024.
正如我們在第 5 張幻燈片中總結的那樣,該專利涵蓋了針對 Rezdiffra 商業體重閾值給藥方案的權利要求,如 FDA 批准的標籤中所述,並將列入 FDA 橙皮書。最近我們了解到一些好消息。該專利的有效期限從先前的 2024 年 9 月 30 日延長至 2045 年 2 月 4 日。
What gives us such high confidence in the strength of this patent is that it's based on the clear and compelling finding that Rezdiffra doses given to two different cohorts of patients each with different body weights optimizes the efficacy and safety of rider. This finding is based directly on our clinical team's independent analysis from our Phase 3 MAESTRO NASH trial, which was adopted by the FDA for our label. The bottom line, any potential generic competitor will need to adopt the Rezdiffra label and would infringe on our patents.
我們對這項專利的強度如此有信心的原因在於,它基於一個明確而令人信服的發現:對兩組不同體重的患者分別給予 Rezdiffra 劑量可優化附加劑量的療效和安全性。這項發現直接基於我們的臨床團隊對第 3 階段 MAESTRO NASH 試驗的獨立分析,該分析已被 FDA 採納用於我們的標籤。底線是,任何潛在的仿製藥競爭對手都需要採用 Rezdiffra 標籤,並且會侵犯我們的專利。
Our confidence in this pattern is also supported by precedent US case law. This patent changes the game for us in two ways. First, strategically, it gives us the privilege of time. This extension creates a lot of flexibility for us to pursue our long-term strategy. We can be very thoughtful and deliberate about how we build our future and shape our pipeline.
我們對這種模式的信心也得到了美國先例法的支持。這項專利從兩個方面改變了我們的遊戲規則。首先,從戰略上來說,它給了我們時間特權。此次延期為我們推行長期策略創造了很大的彈性。我們可以非常認真和謹慎地考慮如何建立我們的未來和塑造我們的管道。
Second, it adds another potential decade of protected revenue and materially increases our value proposition, creates additional opportunity in MASH and extends our ability to keep innovating to address unmet patient needs.
其次,它增加了另一個十年的潛在受保護收入,並實質地增加了我們的價值主張,在 MASH 中創造了更多機會,並擴展了我們不斷創新以滿足未滿足的患者需求的能力。
Now, let's turn to slide 6, and Rezdiffra's second quarter performance, where we delivered net sales of $213 million, up 55% quarter-over-quarter. US Rezdiffra net sales are now annualizing at well over $800 million. The significant demand we're generating is driven by strong and consistent execution on two key launch metrics patients on drug and prescriber penetration.
現在,讓我們翻到第 6 張投影片,看看 Rezdiffra 的第二季業績,我們的淨銷售額達到 2.13 億美元,季增 55%。美國 Rezdiffra 的年淨銷售額目前已超過 8 億美元。我們產生的巨大需求是由對兩個關鍵發布指標——藥物患者和處方滲透率——的強有力和持續執行所驅動的。
First on patients as shown on slide 7. We ended the second quarter of 2025 with more than 23,000 patients on Rezdiffra up from more than 17,000 patients at the end of the first quarter. As we've noted before, this figure represents patients actively on therapy accounting for any discontinuations. We are encouraged by Rezdiffra's robust growth and yet we're still in the early stages of this launch. Only about 7% of the 315,000 diagnosed F2-F3 MASH patients under the care of a liver specialists are being treated with Rezdiffra. There is significant opportunity ahead.
首先針對患者,如投影片 7 所示。截至 2025 年第二季度,使用 Rezdiffra 的患者人數已超過 23,000 人,而第一季末為 17,000 多人。正如我們之前所指出的,這個數字代表了正在積極接受治療的患者人數,即使有患者停止治療。Rezdiffra 的強勁成長令我們感到鼓舞,但我們仍處於此次發布的早期階段。在肝病專家的診治下,315,000 名確診為 F2-F3 MASH 的患者中只有約 7% 接受 Rezdiffra 治療。未來還有重大機會。
Moving to slide 8 and our progress on physician penetration. As I said before, building a strong base of prescribers early in the launch is one of the best indicators of long-term success. That's why the pace of adoption has been so encouraging.
轉到投影片 8,了解我們在醫生滲透方面的進展。正如我之前所說,在產品發布初期建立強大的處方者基礎是長期成功的最佳指標之一。這就是為什麼採用的速度如此令人鼓舞。
In fact, in just over a year since approval, we've achieved another key launch goal. 80% of our 6,000 top targets have prescribed Rezdiffra. This level of penetration exceeds the benchmarks we track and is the direct result of the significant amount of work we've done to wire the system for a first-in-disease launch like Rezdiffra.
事實上,自從獲得批准以來的短短一年多時間裡,我們又實現了另一個關鍵的發布目標。我們 6,000 名主要目標患者中有 80% 都服用了 Rezdiffra。這種滲透程度超出了我們追蹤的基準,是我們為 Rezdiffra 等首次用於疾病治療的藥物上市而進行系統佈線所做的大量工作的直接結果。
We're also seeing strong progress as we expand into our broader 14,000 target prescriber base. By the end of the second quarter, 60% or roughly 8,500 health care providers had written a prescription for Rezdiffra, up from 50% in the first quarter.
隨著我們擴大目標處方者群體至 14,000 名,我們也取得了顯著進展。截至第二季末,60%(約 8,500 名)醫療保健提供者開出了 Rezdiffra 處方,高於第一季的 50%。
Looking ahead, more of our focus will be on Rezdiffra which is also tracking in line with best-in-class launches. We believe this is largely due to the positive experience that providers are having with Rezdiffra, and we anticipate that it will continue to drive depth going forward. And this positive experience is being driven by Rezdiffra's compelling profile shown on slide 9.
展望未來,我們將更專注於 Rezdiffra,它也將與同類最佳產品保持一致。我們相信這很大程度上歸功於供應商對 Rezdiffra 的積極體驗,並且我們預計它將繼續推動未來的深度發展。這種積極的體驗是由幻燈片 9 中展示的 Rezdiffra 引人注目的形象所推動的。
Rezdiffra is the liver-directed medicine with a mechanism of action that improves the critical processes in the liver that drive match. It has consistently strong efficacy regardless of patient subtype, including those with type 2 diabetes, who have a higher risk of progression and comprise approximately 60% of the MASH population.
Rezdiffra 是一種針對肝臟的藥物,其作用機制可以改善肝臟中驅動配對的關鍵過程。無論患者亞型如何,它都具有持續強大的療效,包括患有第 2 型糖尿病的患者,他們的病情進展風險更高,約佔 MASH 族群的 60%。
Additionally, Rezdiffra works effectively regardless of fibrosis stage, BMI or genetic makeup. So it's very consistent when it comes to treatment effect. It's also easy to prescribe and to take a once-daily, well-tolerated pill with no titration requirements. That simplicity matters to physicians, to patients and ultimately, to adherence.
此外,無論纖維化階段、BMI 或基因組成為何,Rezdiffra 都能有效發揮作用。所以就治療效果而言是非常一致的。它也很容易開處方,每天服用一次,耐受性良好,無需滴定的藥丸。這種簡單性對於醫生、對病人、最終對於依從性都很重要。
We continue to see strong early signs of adherence, consistent with what we see from other well-tolerated oral therapies. So as we look ahead to future competition, we believe Rezdiffra's attractive real-world profile gives us a durable advantage. The next potential entrant in MASH is likely to come from the injectable GLP-1 class.
我們繼續看到強烈的早期依從性跡象,這與我們從其他耐受性良好的口服療法中看到的情況一致。因此,展望未來的競爭,我們相信 Rezdiffra 極具吸引力的現實世界形象將為我們帶來持久的優勢。MASH 的下一個潛在進入者很可能來自註射型 GLP-1 類。
And you can see on slide 10, Rezdiffra compares very favorably across key attributes. For example, while semaglutide demonstrated an improvement in fibrosis, it was less pronounced in patients with type 2 diabetes, whereas Rezdiffra works consistently across patient subtypes.
您可以在第 10 張投影片上看到,Rezdiffra 在關鍵屬性方面表現非常出色。例如,雖然司美格魯肽顯示出對纖維化的改善,但在 2 型糖尿病患者中效果不太明顯,而 Rezdiffra 對所有患者亞型均有一致的作用。
Another key difference is adherence in the real world. It's low for semaglutide. Most patients struggle to get to and maintain the 2.4 milligram dose. In addition, only approximately 30% of patients with obesity remain on the medicine after one year. This is especially relevant in math, where we're talking about a 72-week efficacy endpoint.
另一個關鍵的差異是現實世界中的依從性。對於司美格魯肽來說,它很低。大多數患者都難以達到並維持 2.4 毫克的劑量。此外,只有大約 30% 的肥胖患者在一年後仍繼續服用該藥物。這在數學中尤其重要,我們正在討論 72 週的療效終點。
For a progressive chronic disease like MASH, providers want a medicine that patients will stay on and one that they can administer easily without a titration schedule, and that's where Rezdiffra stands out. Certainly, a key attribute of a GLP-1 is its impact on weight loss. And we also know patients with MASH may benefit from a combination approach.
對於像 MASH 這樣的漸進性慢性疾病,醫療服務提供者希望患者能夠堅持服用一種藥物,並且患者可以輕鬆服用而無需滴定計劃,而這正是 Rezdiffra 脫穎而出的地方。當然,GLP-1 的一個關鍵屬性是它對減肥的影響。我們也知道,MASH 患者可能會受益於聯合療法。
Today, about 25% of patients on Rezdiffra are taking it alongside in an injectable GLP-1 to manage their comorbidities and that figure increases to roughly 50% when you include prior GLP-1 users. So combination use is happening in the market today, and we expect it to grow over time.
如今,約有 25% 的 Rezdiffra 患者同時服用注射 GLP-1 來治療合併症,如果算上先前的 GLP-1 使用者,這一數字將上升到約 50%。因此,目前市場上正在出現組合使用,我們預計它會隨著時間的推移而成長。
As we look ahead on slide 11 and consider the upcoming GLP 1 launch in MASH, we believe it has the potential to accelerate the growth opportunity for risk different. Our focus remains squarely on the 315,000 diagnosed patients with moderate to advanced fibrosis. This is our core specialty market.
當我們展望第 11 張幻燈片並考慮即將在 MASH 中推出的 GLP 1 時,我們相信它有可能加速風險差異的成長機會。我們的重點仍放在 315,000 名確診中度至晚期纖維化的患者身上。這是我們的核心專業市場。
Novo is targeting a much larger population, many multiples of our 315,000. Their efforts will raise awareness and drive broader screening, diagnosis and treatment. This will ultimately benefit patients. and we expect it will also benefit risk differ, both as the foundational therapy and match for first-line patients and from the high real-world discontinuation rate of semaglutide.
Novo 的目標族群要大得多,是我們 315,000 人口的許多倍。他們的努力將提高人們的認識並推動更廣泛的篩檢、診斷和治療。這最終將使患者受益。我們預計它也將使風險受益,無論是作為基礎治療還是第一線患者的匹配,以及現實世界中司美格魯肽的高停藥率。
And there is clearly a need in this large and underpenetrated market for multiple mechanisms and better combinations to treat this challenging disease. That's why we're excited to study Rezdiffra in combination with our newly in-licensed oral GLP-1 as noted on slide 12.
在這個龐大且尚未完全滲透的市場中,顯然需要多種機制和更好的組合來治療這種棘手的疾病。這就是為什麼我們很高興將 Rezdiffra 與我們新許可的口服 GLP-1 結合起來進行研究,如幻燈片 12 所示。
We're taking a differentiated approach focused on MASH. We are looking to develop a chronic therapy for a chronic disease with Rezdiffra as the foundation. We want to optimize the efficacy and tolerability and MASH by balancing the right amount of weight loss from a GLP-1 with the fibrosis and lipid reduction of Rezdiffra in a once-daily, well-tolerated pill. And our data has shown that just 5% waive loss can increase Rezdiffra's antifibrotic effect.
我們採取以 MASH 為重點的差異化方法。我們正在尋求以 Rezdiffra 為基礎開發一種治療慢性疾病的慢性療法。我們希望透過平衡 GLP-1 的適當減肥效果與 Rezdiffra 的纖維化和脂質減少效果,優化療效和耐受性以及 MASH,從而實現每日一次、耐受性良好的藥丸。我們的數據表明,僅 5% 的減量損失就能增加 Rezdiffra 的抗纖維化作用。
And as we assess the oral GLP-1 landscape, we had specific criteria that we were looking for. We wanted an orforglipron derivative with a favorable stability and pharmacokinetic profile that was amenable to develop as a combination therapy and a port an asset that was actionable.
當我們評估口服 GLP-1 前景時,我們有特定的標準。我們希望獲得一種具有良好穩定性和藥物動力學特徵的奧格利普龍衍生物,以便將其開發為聯合療法並成為可操作的資產。
We believe that SYH2086 from CSPC Pharma is the right oral GLP-1 asset for our program. It gives us the opportunity to develop what we believe to become a best-in-disease well-tolerated oral combination for MASH. Importantly, we secured this asset with favorable terms.
我們相信,石藥集團的 SYH2086 是我們專案適當的口服 GLP-1 藥物。它使我們有機會開發出我們認為最適合 MASH 疾病且耐受性良好的口服組合藥物。重要的是,我們以優惠的條件獲得了這項資產。
We have exclusive global rights for $120 million upfront payment and potential future payments based on achievement of development, regulatory, and commercial milestones. We expect the transaction to close in the fourth quarter and expect to enter the clinic in the first half of next year. We will provide additional updates on our clinical development plans on future calls.
我們擁有 1.2 億美元預付款的全球獨家權利,根據開發、監管和商業里程碑的實現,未來可能會獲得付款。我們預計交易將在第四季度完成,並預計在明年上半年進入臨床。我們將在未來的電話會議上提供有關我們的臨床開發計劃的更多更新。
Let's briefly move on to two additional growth opportunities, starting with the international expansion of Rezdiffra on slide 13. In June, we received a positive CHMP opinion, a key regulatory milestone that sets the stage for approval across the European Union. We expect the final decision from the European Commission later this month and are preparing to launch in Germany in the second half of this year.
讓我們簡要地討論另外兩個成長機會,首先是幻燈片 13 上的 Rezdiffra 的國際擴張。6 月份,我們收到了 CHMP 的積極意見,這是一個重要的監管里程碑,為整個歐盟的批准奠定了基礎。我們預計歐盟委員會將於本月稍後做出最終決定,並準備在今年下半年在德國推出。
As we've discussed, we've made an incredible amount of progress in Germany over the last year. Leadership in our field teams are in place, we understand which providers treat MASH. -- we're continuing to engage in disease education. We've begun our efforts to wire the system. And importantly, European guidelines already include Rezdiffra as a first-line treatment for MASH, which positions us well.
正如我們所討論的,過去一年我們在德國取得了令人難以置信的進步。我們的現場團隊的領導已經到位,我們了解哪些提供者可以治療 MASH。 ——我們將持續參與疾病教育。我們已經開始努力連結系統。重要的是,歐洲指南已將 Rezdiffra 列為 MASH 的一線治療藥物,這為我們提供了有利條件。
Like the US, we've defined our initial target population as patients already diagnosed with F2-F3 match and under the care of a liver specialist. Based on our research, we estimate that the population is approximately 370,000 patients across Europe. We believe Rezdiffra can be the first medicine approved for MASH in Europe and the foundational therapy for this population just as we've established in the US.
與美國一樣,我們將最初的目標族群定義為已被診斷為 F2-F3 匹配並接受肝病專家護理的患者。根據我們的研究,我們估計整個歐洲的患者人數約為 37 萬人。我們相信,Rezdiffra 可以成為歐洲首個獲準用於治療 MASH 的藥物,並成為該族群的基礎療法,就像我們在美國建立的一樣。
Let's move to slide 14 and the opportunity we see in compensated MASH cirrhosis or F4c, an important next step in our growth strategy. First, there is a high unmet need with no approved treatments and serious risk of progression. Second, resi liver-directed mechanism targeting fibrosis is well suited for cirrhosis. Third, our two-year open-label data presented at EASL showed sustained efficacy and supports our confidence in the ongoing MAESTRO-NASH outcomes trial. No other product or mechanism in development has shown this level of reduction in liver stiffness with such an attractive product profile.
讓我們轉到第 14 張投影片,我們在補償性 MASH 肝硬化或 F4c 中看到的機會,這是我們成長策略的下一個重要步驟。首先,存在很大的未滿足需求,沒有批准的治療方法,並且存在嚴重的進展風險。其次,針對纖維化的肝臟導向機制非常適合肝硬化。第三,我們在 EASL 上展示的兩年開放標籤數據顯示了持續的療效,並支持了我們對正在進行的 MAESTRO-NASH 結果試驗的信心。沒有其他正在開發的產品或機制能夠表現出如此程度的肝臟硬度降低,並且具有如此吸引人的產品特性。
And finally, we have real-world momentum, a clear first-mover advantage with outcomes data expected in 2027 and what we believe will be a best-in-disease profile in F4c. We've learned what it takes to launch in NASH, and we're ready to extend that leadership from F2 to F4c period.
最後,我們擁有現實世界的動力,明顯的先發優勢,預計 2027 年將獲得結果數據,我們相信這將是 F4c 中最佳的疾病概況。我們已經了解了在 NASH 中啟動所需的條件,我們準備將這種領導地位從 F2 延長到 F4c 時期。
Slide 15 outlines the opportunity we see in F4c. We've taken a thoughtful approach to understanding the F4c population. Our research shows there are approximately 245,000 patients in the US with compensated MASH cirrhosis who are already diagnosed and under the care of our target liver specialists. These patients are sicker and further along in disease progression, which typically translates to greater and faster adoption. That's why we believe F4c has the potential to effectively double Rezdiffra's market opportunity in the US.
投影片 15 概述了我們在 F4c 中看到的機會。我們採取了深思熟慮的方法來了解 F4c 人群。我們的研究表明,美國大約有 245,000 名代償性 MASH 肝硬化患者,這些患者已被診斷並接受我們目標肝病專家的治療。這些患者的病情更加嚴重,病情進展也更加迅速,這通常意味著採用率更高、更快。這就是為什麼我們相信 F4c 有潛力有效地使 Rezdiffra 在美國的市場機會翻倍。
With that, I'll hand it over to Dave to walk through the data on slide 16.
說完這些,我將交給戴夫來介紹第 16 張投影片上的數據。
David Soergel - Executive Vice President, Chief Medical Officer
David Soergel - Executive Vice President, Chief Medical Officer
Thanks, Bill. I'll walk through the takeaways now from our two-year open-label extension data in F4c, which we presented at EASL.
謝謝,比爾。現在我將介紹我們在 EASL 上展示的 F4c 兩年開放標籤擴充資料的要點。
First, let's look at the liver stiffness data as measured by vibration controlled transient [lostography] or VCT Patients experienced a mean reduction of 6.7 kilopascals in liver stiffness at two years, statistically significant versus baseline. But we have achieved at least 25% reduction in liver stiffness.
首先,讓我們來看看透過振動控制瞬態 [lostography] 或 VCT 測量的肝臟硬度數據,患者的肝臟硬度在兩年內平均降低了 6.7 千帕,與基線相比具有統計意義。但我們已經將肝臟硬度降低了至少25%。
As published in JAMA, that level of improvement is tied to a lower risk of progression to end-stage liver disease. And 35% of patients met the criteria for regression from F4 to F3, suggesting potential reversal of cirrhosis.
正如《美國醫學會雜誌》所發表的,這種程度的改善與降低進展為末期肝病的風險有關。35%的患者符合F4到F3的退化標準,提示肝硬化有可能逆轉。
Turning to slide 17. Another critical point is Rezdiffra's potential ability to reduce the risk of clinically significant portal hypertension or CSPH. CSPH is a key driver of the most severe outcomes of cirrhosis, like ascites, variceal bleeding and hepatic encophalopathy. It marks the tipping point into decompensated disease.
翻到第 17 張投影片。另一個關鍵點是 Rezdiffra 具有降低臨床顯著門靜脈高壓或 CSPH 風險的潛在能力。CSPH 是導致肝硬化最嚴重後果(如腹水、靜脈曲張出血和肝性腦病變)的關鍵因素。它標誌著失代償性疾病的臨界點。
In our open-label study, 65% of patients with CSPH at baseline improved to a lower risk category by year two. That movement away from high-risk CSPH suggests Rezdiffra could help the layer prevent life-threatening complications.
在我們的開放標籤研究中,65% 的基線 CSPH 患者到第二年病情改善至較低風險類別。遠離高風險 CSPH 的舉動表明 Rezdiffra 可以幫助蛋雞預防危及生命的併發症。
Taken together, these data support our confidence in the ongoing Phase 3 MAESTRO-NASH outcomes trial because the baseline characteristics of the patients in the open-label study align closely with those in our F4 outcomes trial. For us, this means Rezdiffra has the potential to become the first approved treatment for compensated MASH cirrhosis, a very sick segment of the MASH market that currently has no therapeutic options.
綜合起來,這些數據支持了我們對正在進行的 3 期 MAESTRO-NASH 結果試驗的信心,因為開放標籤研究中患者的基線特徵與我們的 F4 結果試驗中的患者基線特徵非常吻合。對我們來說,這意味著 Rezdiffra 有可能成為第一個核准的治療代償性 MASH 肝硬化的藥物,這是 MASH 市場中一個非常嚴重的問題,目前沒有治療選擇。
I'll now turn the call over to Mardi.
現在我將把電話轉給 Mardi。
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
Yes. Thank you, Dave. Second quarter 2025 net sales totaled $212.8 million, up 55% from the first quarter of 2025. This was another strong demand quarter. As we've said, we expected gross to net to be somewhat choppy early in launch, and the team has done an outstanding job managing it to date. As we shared last quarter, we've begun contracting with payers.
是的。謝謝你,戴夫。2025 年第二季淨銷售額總計 2.128 億美元,較 2025 年第一季成長 55%。這是又一個需求強勁的季度。正如我們所說,我們預計在發布初期總收入與淨收入之間會有些波動,但到目前為止,團隊在管理這一問題上做得非常出色。正如我們上個季度所分享的,我們已經開始與付款人簽訂合約。
We saw minimal additional impact from contracting in the second quarter with an expectation for that to increase our gross to net discount in the back half of the year. that's fully expected and consistent with what we typically see with specialty medicines at this point in their launches. We have good visibility into the growth-to-net dynamic this year and are confident that gross to net will remain within our expected range through 2025.
我們看到第二季合約帶來的額外影響微乎其微,預計這將在下半年增加我們的毛利率與淨利率的對比。這是完全可以預料到的,並且與我們在特種藥品上市時通常看到的情況一致。我們對今年的成長與淨值的動態有很好的了解,並有信心到 2025 年總淨值將保持在我們預期的範圍內。
R&D expenses for the second quarter of 2025 were $54.1 million compared to $71.1 million in the second quarter of 2024. The decrease was primarily due to lower clinical trial costs. SG&A expenses for the second quarter of 2025 were $196.9 million compared to $105.4 million in the second quarter of 2024. The increase was primarily due to increases in commercial launch activities for was different. Looking ahead, we expect operating expenses in the third and fourth quarters to be modestly higher than the second quarter.
2025 年第二季的研發費用為 5,410 萬美元,而 2024 年第二季為 7,110 萬美元。下降的主要原因是臨床試驗成本降低。2025 年第二季的銷售、一般及行政費用為 1.969 億美元,而 2024 年第二季為 1.054 億美元。這一增長主要是由於商業發射活動的增加所致。展望未來,我們預計第三季和第四季的營運費用將略高於第二季。
Turning to our balance sheet. We ended the second quarter of 2025 with $802 million in cash, cash equivalents, restricted cash and marketable securities. As Bill mentioned earlier in July, we also entered into an agreement with Blue Owl Capital for up to $500 million in a senior secured credit facility on favorable terms.
轉向我們的資產負債表。截至 2025 年第二季度,我們擁有 8.02 億美元的現金、現金等價物、受限現金和有價證券。正如比爾 7 月早些時候提到的,我們還與 Blue Owl Capital 達成了一項協議,以優惠條件提供高達 5 億美元的優先擔保信貸額度。
This non-diluted financing consists of a $350 million initial term loan funded at closing, a portion of which was used to repay all outstanding obligations under the Hercules loan facility and $150 million delayed draw term available in multiple draws through 2027. We plan to use these funds to pay the upfront payment for the global license of our oral GLP-1.
該非稀釋融資包括在交易結束時提供的 3.5 億美元初始定期貸款,其中一部分用於償還 Hercules 貸款協議下的所有未償債務,以及可在 2027 年前分次提取的 1.5 億美元延期提款期限。我們計劃用這些資金支付我們口服GLP-1全球許可的預付款。
The Blue Owl agreement also provides a mutual -- provides a mutual option for an additional uncommitted tranche of up to $250 million to support potential additional strategic business development activities. With this strong cash position, we continue to be well resourced to support the ongoing launch of Rezdiffra in both the US and our planned launch in Europe in the second half of this year. as well as for business development opportunities to build our pipeline going forward.
Blue Owl 協議還提供了一項共同選擇權,即額外提供高達 2.5 億美元的未承諾款項,以支持潛在的額外策略性業務發展活動。憑藉強大的現金狀況,我們將繼續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於今年下半年在歐洲的推出,以及支持業務發展機會以建立我們未來的產品線。
So with that, let me briefly recap our second quarter progress on slide 19. We continue to drive strong momentum in the fifth quarter of our launch with a medicine that's now annualizing at well over $800 million. We have more than 23,000 patients on therapy and expect to continue to steadily add patients going forward.
因此,請允許我在第 19 張投影片上簡要回顧我們第二季度的進展。在推出該藥物後的第五季度,我們繼續保持強勁勢頭,目前該藥物的年銷售額已超過 8 億美元。我們有超過 23,000 名患者正在接受治療,並且預計未來患者數量將繼續穩定增加。
Physician adoption continues to build. We hit a key launch goal with 80% of our 6,000 top targets now prescribing Rezdiffra and we're expanding our leadership in F2 to F4c MASH with our new patent confirming Rezdiffra protection to February 2045, our progress in F4c, our expected expansion into Europe and our exciting new oral GLP-1 global licensing agreement.
醫生的採用率持續上升。我們實現了一個關鍵的發布目標,我們的 6,000 個頂級目標中有 80% 現在都開著 Rezdiffra,而且我們正在擴大我們在 F2 到 F4c MASH 領域的領導地位,我們的新專利確認 Rezdiffra 的保護期限為 2045 年 2 月,我們在 F4c 方面的口服協議,並且我們將令人興奮的口服協議
And now I'll turn the call back to Tina to open up the Q&A session.
現在我將把電話轉回給蒂娜,開始問答環節。
Tina Ventura - Chief Investor Relations
Tina Ventura - Chief Investor Relations
Thanks, Mardi. Let's move into the Q&A portion of the call. Demi, please go ahead and provide instructions for the Q&A session.
謝謝,馬迪。讓我們進入通話的問答部分。黛米,請繼續並提供問答環節的說明。
Operator
Operator
(Operator Instructions) Thomas Smith, Leerink Partners.
(操作員指示)Thomas Smith,Leerink Partners。
Thomas Smith - Analyst
Thomas Smith - Analyst
I was wondering if you could just expand on the comments regarding gross to net and the inventory dynamics in the quarter. I know you guided to there being a little bit of choppiness, but it looks like you may have benefited perhaps from better net pricing in the quarter versus Q1. If you could just help us frame where you see this going for the rest of the year? And then if you could just comment on inventory stocking in the quarter, that would be really helpful.
我想知道您是否可以詳細說明有關本季度總額與淨額以及庫存動態的評論。我知道您預測會有一點波動,但看起來您可能已經從本季度比第一季更好的淨定價中受益。您能否幫我們預測今年剩餘時間的情況?然後,如果您能對本季的庫存情況進行評論,那將非常有幫助。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Hey Tom, thanks very much. Mardi, I'm going to turn it over to you to talk about gross to net.
嘿,湯姆,非常感謝。馬迪,我現在要把話題交給你來討論總額與淨額的關係。
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
Yeah. Great. Tom, thank you for the question. Let's just start with saying that this is a really strong demand quarter. and the team executed so well once again. Now with respect to gross to net that we addressed in the call that we've been very disciplined and we'll remain disciplined when it comes to gross to net. And we've been very consistent with our messages quarter-to-quarter. We said from the start of launch that gross to net will be choppy early in the launch, and we're still just five quarters in. So that's the case what we've seen here in this quarter.
是的。偉大的。湯姆,謝謝你的提問。首先要說的是,這是一個需求非常強勁的季度,而且團隊的表現再次非常出色。現在,關於我們在電話會議中提到的毛利與淨利之比,我們一直非常嚴謹,在毛利與淨利之比問題上,我們將繼續保持嚴謹。我們每季發布的信息都非常一致。我們從發布之初就說過,毛利率與淨利率之間的變化在發布初期會比較劇烈,而現在我們才剛開始第五個季度。這就是我們在本季看到的情況。
We did say last quarter that we began contracting in April and we also anticipated that we would have minimal additional impact from contracting this quarter and expect to see more of that impact in the second half of the year. So we've explained that we are very focused on gross to net. We have very good visibility and that we plan to stay within the range that we've discussed previously, that's very typical for specialty pharma launches at this point in their launch.
我們上個季度確實說過,我們從 4 月開始簽訂合同,我們也預計本季簽訂合約對我們產生的額外影響將很小,預計下半年將產生更大的影響。因此,我們已經解釋過,我們非常關注總額與淨額的關係。我們擁有非常好的知名度,我們計劃保持在我們之前討論過的範圍內,這對於專業製藥公司在其發布的這個階段來說非常典型。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Yeah. Thanks, Mardi. Look, and Tom, as you've heard me say, we've been extremely diligent about gross to net from the beginning, and we don't think about it in terms of quarter-to-quarter. We've taken a very long-term view looking over multiple years. We know that Rezdiffra is going to be a big product and gross to net is really important.
是的。謝謝,馬迪。你看,湯姆,正如你聽到我說的,我們從一開始就非常勤奮地考慮毛利與淨利之間的比率,我們不會以季度為單位來考慮這個問題。我們已經採取了非常長遠的眼光,並著眼於多年的發展。我們知道 Rezdiffra 將會成為一款大產品,毛利與淨利的比率非常重要。
So you want to watch it and work very carefully on it and make sure that you preserve it. So our team has done just an outstanding job on it. And so we feel really good about where we're at. And as Mardi said, we've got a real strong sense of how it will evolve and where we're going.
所以你要觀察它、仔細地處理它並確保保存它。所以我們的團隊在這方面做得非常好。因此,我們對目前的狀況感到非常滿意。正如馬迪所說,我們非常清楚它將如何發展以及我們將走向何方。
Operator
Operator
Yasmeen Rahimi, Piper Sadler.
亞斯明·拉希米、派珀·薩德勒。
Yasmeen Rahimi - Analyst
Yasmeen Rahimi - Analyst
Congrats, an outstanding quarter. I guess, team, one of the questions that I think seems to be investors asking as with the entrance of GLP-1 to the market. Let's say you maintain your pricing strategy and don't aggressively rebate to the level of matching semaglutide, how do you foresee sort of maintaining the strong growth curve that you have shown so far -- and I think it's very clear that hepatologists are going to prefer liver-directed therapies. But if there is a prior authorization of GLP-1 steps at it's -- needed due to pricing differences. How do you foresee how soon that could play flat out and not become as important. So if you could just talk about that dynamic, we get that question quite a bit, and I'm sure so do you?
恭喜,這是一個出色的季度。我想,團隊,我認為投資者似乎會問的一個問題是 GLP-1 進入市場。假設您維持您的定價策略並且不大幅降低與司美格魯肽相當的折扣水平,您如何預見到能夠維持迄今為止所顯示的強勁增長曲線?我認為很明顯肝病專家會比較喜歡針對肝臟的療法。但如果事先授權 GLP-1 步驟,則由於定價差異而需要這樣做。您如何預見這種情況很快就會消失並且不再那麼重要?因此,如果您可以談論一下這種動態,我們經常會問到這個問題,我相信您也是嗎?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
There's a lot of questions in nuance in there. So let me just kind of roll through a little bit -- provide a little bit of context here. I mean, as we said, we're coming off an outstanding second quarter which was driven by strong demand. So number -- and we've been steadily adding patients since launch, and that doesn't change. things through the SEMA launch in the second half of the year.
這裡面有很多細微的問題。因此,請允許我稍微介紹一下——在這裡提供一些背景資訊。我的意思是,正如我們所說,在強勁需求的推動下,我們第二季的業績表現出色。所以數量——自推出以來,我們一直在穩步增加患者,這一點沒有改變。透過今年下半年的 SEMA 推出,事情發生了變化。
Now in addition to the strong demand with our -- from the Q1 effect. So we would expect our quarter-over-quarter growth rates to continue to track right in line with other successful specialty launches with similar dynamics.
現在,除了我們第一季產生的強勁需求之外。因此,我們預計我們的季度環比成長率將繼續與其他具有類似動態的成功專業產品保持一致。
And you heard Mardi talk about gross to net that is being choppy quarter-to-quarter. We have good visibility and expect for that gross to net discount to step up in 2025, but stay within the specialty product range that we've discussed. So everything I've said there is in the context of expecting a SEMA approval and launch.
您聽到 Mardi 談到毛利潤與淨利潤之間的季度變化。我們擁有良好的預見性,並預計 2025 年毛利與淨利的折扣將會增加,但仍將保持在我們討論過的專業產品範圍內。所以我所說的一切都是在期待 SEMA 批准和發布的背景下的。
Now you asked a very specific question about step edits and so forth. Now look, right now, it's just a little too early to tell. Product hasn't approved yet. We don't know what the label looks like. And those are going to be taken into consideration in the discussions that we have with payers.
現在您問了一個關於步驟編輯等非常具體的問題。現在看看,現在說這些還太早。產品尚未批准。我們不知道標籤是什麼樣子的。我們將在與付款人的討論中考慮這些因素。
We've been actively talking with payers. We think that we've established a good partnership and planning with players payers, but we're waiting to see ultimately what happens with the label and approval of semaglutide. Either way, we plan for all scenarios. And a step at it here in this space though is somewhat complicated.
我們一直在積極與付款人溝通。我們認為我們已經與球員付款人建立了良好的合作夥伴關係和規劃,但我們正在等待最終觀察司美格魯肽的標籤和批准情況。無論如何,我們都會為所有情況做好計劃。然而,在這個領域邁出這一步有些複雜。
And I think that, that's going to be one of the things to take into consideration because these patients have other comorbid conditions such as type 2 diabetes or cardiovascular disease. So think about it. If a patient is well controlled on a different GLP-1 would a payer disrupt their current therapy to put them on SEMA for MASH so there's a lot of nuance and complications here. We don't have all the data yet, but we have planned for all eventualities, and it doesn't change our excitement for the opportunity that exists
我認為,這是需要考慮的事情之一,因為這些患者也患有其他合併症,例如第 2 型糖尿病或心血管疾病。所以考慮一下。如果患者透過不同的 GLP-1 得到良好的控制,付款人是否會中斷他們目前的治療,讓他們接受 SEMA 治療 MASH,因此這裡存在著許多細微差別和複雜性。我們還沒有掌握所有數據,但我們已經為所有可能發生的情況做好了計劃,但這並沒有改變我們對現有機會的興奮之情
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
And yes, I would just add one more thing is, remember, GLPs have been on the market for a long time. And our data has been pretty consistent what we've seen to date that of the patients that we've treated about 50% are either on or have exposure to GLP-1s already and probably 25% are on at any given time. So there's a lot of familiarity in the market already. And clearly, combination use is already established.
是的,我只想補充一點,請記住,GLP 已經上市很久了。我們的數據非常一致,迄今為止我們看到,在我們治療的患者中,大約 50% 正在服用或已經接觸過 GLP-1,並且可能有 25% 在任何特定時間都在服用。因此市場已經對此有了相當程度的熟悉。顯然,組合使用已經確立。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Yeah. It's a really great point, Mardi because this isn't as though it's a new product that's entering the market that's never been used I mean this has been used everywhere. There's nobody who hasn't heard of it or has the ability to get it for some indication now. This is just an extension. So that's a very different setup than if you have a brand-new mechanism of action entering a market, which has more potential to disrupt.
是的。這是一個非常好的觀點,Mardi,因為這不是一個剛進入市場、從未被使用過的產品,我的意思是它已經在各個地方被使用了。現在沒有人沒有聽說過它或有能力從某種程度上得到它。這只是一個擴展。因此,這與採用全新的行動機制進入市場相比,設定非常不同,而且這種機制更有可能造成破壞。
Operator
Operator
Jonathan Wolleben, Citizens.
喬納森‧沃勒本(Jonathan Wolleben),《公民報》。
Unidentified Participant
Unidentified Participant
This is Catherine on for John. I just had a quick question about your new GLP, or GLP-1 -- and just how many did you look at -- and how did you go about I know you said that though orforglipron backbone was kind of in factor. But just could you provide a little bit of color on that.
我是凱瑟琳,代替約翰。我只是想問一下您的新 GLP 或 GLP-1,您研究了多少個,以及您是如何進行的,我知道您說過,儘管 orforglipron 的骨幹是一種因素。但您能否對此提供一些解釋?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Yeah. Look, thanks for the question. as we've said for a long time, BD is a part of our strategy. and we're looking to add the right assets to our pipeline to extend our leadership in MASH. Oral GLP-1s are something that we've been interested for a long time like with any BD process, you look at a lot of different things before you find the one that's just right. And that's what we did. We laid out what we were looking for.
是的。瞧,謝謝你的提問。正如我們長期以來所說的那樣,BD 是我們策略的一部分。我們希望在我們的產品線中添加合適的資產,以擴大我們在 MASH 中的領導地位。我們對口服 GLP-1 一直很感興趣,就像任何 BD 流程一樣,在找到最合適的方案之前,需要考慮很多不同的事情。我們也確實這麼做了。我們列出了我們正在尋找的東西。
We were looking for a orforglipron derivative. We wanted favorable stability in the TK profile that's amenable to combo, and we found that in this asset. So it was a very systematic approach.
我們正在尋找奧格列酮的衍生物。我們希望 TK 設定檔具有良好的穩定性,以便進行組合,並且我們在該資產中找到了它。所以這是一種非常有系統的方法。
We looked at a lot of things before deciding and coming upon the one that we think is just right to create that product which we think is going to be a next advancement in MASH.
在決定並找到我們認為最合適的產品之前,我們考慮了許多因素,我們認為這將是 MASH 的下一個進步。
Now just the one thing I'll say, there are a lot of oral GLP-1s out there. There are a lot of GLP-1s, GGGs, et cetera, but there's only one that's going to be combined with risk differ in this form. And that's how we differentiate in this market. That's something which is special to magical, and that's something that we see a huge opportunity for us.
現在我只想說一件事,市面上有很多口服 GLP-1。有許多 GLP-1、GGG 等等,但只有一種會以這種形式與風險不同地結合。這就是我們在這個市場上的差異化優勢。這對於魔術來說很特別,對我們來說也是一個巨大的機會。
Operator
Operator
Eliana Merle, UBS.
瑞銀的 Eliana Merle。
Eliana Merle - Analyst
Eliana Merle - Analyst
Congrats on the quarter. In terms of next year, how are you thinking about sequential quarterly growth once SEMA is available? And specifically on gross to net, can you give us a little bit more color on how you're thinking about how that could trend next year? And lastly, I feel free to not answer this question, but what's your latest thinking around when you might be in a position to issue revenue guidance?
恭喜本季取得佳績。就明年而言,一旦 SEMA 推出,您如何看待連續季度成長?特別是從總額到淨額,您能否向我們詳細介紹您對明年趨勢的看法?最後,我可以不回答這個問題,但是您對何時可以發布收入指導有什麼最新想法?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Do you want to take the revenue guidance or anything or any part of it?
您想接受收入指導或任何內容或其任何部分嗎?
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
Yeah. Thanks, Ellie. Thanks for the question. So revenue guidance is easy. We haven't discussed that publicly and we have no plans in the near term to give guidance.
是的。謝謝,艾莉。謝謝你的提問。因此收入指導很容易。我們尚未公開討論過這個問題,而且我們近期也沒有提供指導的計劃。
In terms of growth, you're asking about 2026 already, that we're in Q2 of 2025. So we're focused on the rest of the year of 2025. And we've discussed on the call and we'll say it again now that we believe that we'll be steadily adding patients through the rest of the year and continue our growth trend.
就成長而言,您已經詢問了 2026 年的情況,我們現在處於 2025 年第二季。因此,我們的重點是 2025 年剩餘時間。我們已經在電話會議上討論過了,現在我們再說一遍,我們相信在今年剩餘時間內我們將穩步增加患者數量並繼續保持增長趨勢。
And as you know, we follow a basket of analogs of specialty medicines that have launched successfully over the last 10 years, and we are tracking right along that growth rate of those top analogs in this basket. S
如您所知,我們追蹤了過去 10 年內成功推出的一籃子特種藥物類似物,並且我們正在追蹤該籃子中頂級類似物的成長率。秒
o we feel very good about the growth in the rest of the year. And then gross to net, I think we made those comments in 2025, and we feel good and have good predictability. And as the year goes on, then we'll start focusing on 2026 and discussing that more.
o 我們對今年剩餘時間的成長感到非常樂觀。然後從總額到淨額,我想我們在 2025 年做出了這些評論,我們感覺良好並且具有良好的可預測性。隨著時間的推移,我們將開始關注 2026 年並對此進行更多討論。
Operator
Operator
Andrea Newkirk, Goldman Sachs.
高盛的安德里亞紐柯克 (Andrea Newkirk)。
Andrea Tan - Analyst
Andrea Tan - Analyst
Congratulations on the quarter. Bill, just as you think to a potential EU approval -- just curious how you're thinking about the shape of a potential launch curve there versus what you've seen in the US? And when might you expect to recognize first revenue?
恭喜本季。比爾,正如您所想的那樣,歐盟可能會批准這項技術——我只是好奇,與美國的情況相比,您如何看待歐盟的潛在發布曲線形狀?您預計何時能確認第一筆收入?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Thanks, Andrea. Look, I think we've got a very good view on what curves can look like having just gone through the US launch. It all starts with how you wire the system, how do you prepare? How do you educate, how do you create pathways for patients there.
謝謝,安德里亞。瞧,我認為,在剛完成美國市場的發布後,我們對曲線的樣子有了非常好的了解。一切都始於您如何連結系統、如何準備?您如何教育患者,如何為患者創造途徑。
Now the benefit in Europe is they've had more time to prepare for this launch than the US did. Because remember, in the US, since we were the first product ever approved in MASH, the community had been met with disappointment over 20 times.
現在歐洲的優勢在於他們比美國有更多的時間來準備這次發射。因為請記住,在美國,自從我們成為 MASH 批准的第一個產品以來,社區已經遭遇了 20 多次失望。
There's the guidelines in Europe that exist already and with the US getting approved, Europe had a little bit longer to prepare -- but like any other launch and especially when it's a first in disease, it takes time, and we have some really good first-hand experience with that in the US and we're taking essentially all the learnings from the US and transferring them to the really outstanding team that we've hired in Europe and specifically Germany and I just want to put a fine point on that. It's Germany that we're launching in first. We're not going everywhere all at once. We put extremely rigid guidelines in place for what we need to see in a market for it to launch.
歐洲已經有了指導方針,隨著美國的批准,歐洲有更長的時間來準備——但就像任何其他產品的推出一樣,特別是當它是疾病領域的首創產品時,它需要時間,我們在美國擁有一些非常好的第一手經驗,我們正在吸取美國的所有經驗,並將它們轉移到我們在歐洲(特別是德國)聘請的優秀團隊,我只是想強調這一點。我們首先在德國推出這項服務。我們不會同時去所有地方。我們針對產品上市所需的市場條件製定了極為嚴格的指導方針。
So more to come when will we start recognizing revenue, look, I would say it's really not much of a -- there's not much happening in we're going to be starting in the second half of the year in order to get the teams deployed, et cetera, it takes a little time. So really, it's more of a '26 and on story.
那麼,我們什麼時候開始確認收入呢?看,我想說這真的不多——我們將在下半年開始部署團隊等等,這需要一點時間。所以實際上,這更像是一個 26 年左右的故事。
Operator
Operator
Andy Chen, Wolfe Research.
安迪‧陳 (Andy Chen),沃爾夫研究公司 (Wolfe Research)。
Andy Chen - Analyst
Andy Chen - Analyst
Mardi, you talked about this basket of specialty drugs. Can you give some numbers around what this gross to net range is in that basket that you're analyzing? And then this 20% to 30% at the gross to net that you're guiding to, is that an educated guess and prediction? Or is that already a largely known fact given your existing contracting negotiations and you know that it's going to end up in the 20%, 30% range?
馬迪,你談到了這籃子特種藥物。您能否給出一些數字來說明您正在分析的籃子中的總額和淨額範圍是多少?那麼,您所指導的毛利率與淨利率之比為 20% 到 30%,這是一個有根據的猜測和預測嗎?或者根據您現有的合約談判,這已經是一個眾所周知的事實,並且您知道最終比例將在 20% 到 30% 的範圍內?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Hey, Andy, thanks for that. I'll turn it over to Mardi in a second.
嘿,安迪,謝謝你。我馬上就把它交給 Mardi。
Just to be clear on that. We are very, very clear on the 20% to 30% that is based on decades of experience and knowledge and how our conversations have gone with the payer community. So like everything else that we talked about in this launch, we've been very accurate in our comments that we make to all of you. So maybe I'll turn it over to Mardi for any other comment that you have. But look, we don't say things just to say things. We save things because we're confident in them.
只是為了清楚這一點。我們非常清楚這 20% 到 30% 的比例,這是基於數十年的經驗和知識,以及我們與付款人社群的對話情況。因此,就像我們在這次發布會上討論的所有其他內容一樣,我們對大家的評論非常準確。因此,也許我會將其交給 Mardi,以徵求您的其他意見。但是你看,我們說話不只是為了說話。我們保存物品是因為我們對它們有信心。
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
Yeah, just to reiterate that, Andy, we have good visibility for the rest of the year. We've talked about this range since I think our first launch quarter, and we feel very strong that we're tracking along with typical specialty medicines and that the gross to net for 2025 falls within that range. And there's a lot of components to gross to net, many components, of which contracting is just one and we did say we started contracting in April, and then you'd see more of that in the second half.
是的,安迪,我重申一下,我們對今年剩餘時間的前景看好。自從我們的第一個發布季度以來,我們就一直在討論這個範圍,我們非常有信心,我們正在追蹤典型的特種藥物,並且 2025 年的毛利與淨利將落在這個範圍內。從總額到淨額有很多組成部分,其中簽約只是其中之一,我們確實說過我們在四月份開始簽約,然後你會在下半年看到更多簽約。
That's just the natural dynamics in this marketplace and launching in the US, all very predictable for 2025 as we move forward. So we feel good about that. And just to reiterate a point that is to, we haven't commented on 2026, but we see this drug as continued growth and robust growth as we move forward and as we steadily add patients.
這只是這個市場和在美國推出的自然動態,隨著我們不斷前進,2025 年的情況都非常可預測。因此我們對此感到很高興。再次重申一點,我們還沒有對 2026 年發表評論,但隨著我們繼續前進並穩步增加患者,我們認為這種藥物將持續增長且強勁增長。
Operator
Operator
Ritu Baral,TD Cowen.
Ritu Baral,TD Cowen。
Ritu Baral - Analyst
Ritu Baral - Analyst
I wanted to ask about some of your underlying plans, Bill, as far as continuing this growth momentum into the potential adobe label expansion. You hit your target of 80% prescribers in that top tier. What's the next target? And how does that overlap with your understanding of Novo's potential detailing target for that label expansion.
比爾,我想問您的一些基本計劃,關於如何將這種增長勢頭延續到潛在的 Adobe 標籤擴張中。您已達到最高等級處方者人數 80% 的目標。下一個目標是什麼?這與您對 Novo 對該標籤擴展的潛在詳細目標的理解有何重疊?
And as part of that answer, could you address the sort of growing awareness of mass in the diabetic population and amongst endocrinologists? Are they part of that next year?
作為回答的一部分,您能否談談糖尿病患者和內分泌學家對體重日益增長的認識?他們是明年的一部分嗎?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Thanks, Ritu. Look, we don't have a next target that we're going to talk about. Really what happens now is it's a focus on depth. I mean we have -- the breadth of prescribing that we're seeing is as we said, it's leading the other products that we're looking at, the analogs. So we have done just an outstanding job there.
謝謝,Ritu。瞧,我們還沒有要討論的下一個目標。現在真正發生的是關注深度。我的意思是,正如我們所說,我們所看到的處方範圍領先於我們正在研究的其他產品,即類似物。所以我們在那裡做得非常出色。
So it really becomes a depth story now, and we're seeing all the signs that we're tracking right with those analogs as well. So that's the next -- the first leading indicator is really the breadth now you go to depth, and we're seeing more of that. And why do people use more because they see the results, the real-world experience that we're seeing is actually very impressive.
所以現在它真的變成了一個有深度的故事,而且我們看到所有的跡像都表明我們也在用這些類似物進行正確的追蹤。那麼接下來——第一個領先指標實際上是廣度,現在來看看深度,我們看到了更多這樣的指標。為什麼人們會使用更多,因為他們看到了結果,我們看到的真實世界的體驗實際上非常令人印象深刻。
We have physicians every physician I speak with talks about just how -- what they're seeing in the real world is impressive and exceeding expectations. So you talked about kind of where do we go from here from an endocrinology perspective? Yes, endocrinology, there is some. It's not all of endocrinology, but some endocrinologists are very excited about Rezdiffra. And we started spending a little bit more time with those physicians, and we'll continue to do so.
我們有醫生,與我交談的每一位醫生都談到他們在現實世界中所看到的情況令人印象深刻且超出了預期。那麼,您從內分泌學的角度談論了我們下一步該怎麼做?是的,內分泌學有一些。雖然這不是內分泌學的全部,但一些內分泌學家對 Rezdiffra 感到非常興奮。我們開始花更多的時間與這些醫生在一起,我們將繼續這樣做。
As I said, the key focus is hepatologists and gastroenterologists. And we also talked about endocrinologists, but we'll continue to pursue additional endocrinologists that have an interest. Interesting, endocrinologists are super interested in mechanism of action. And this being a THR-beta, their eyes light up saying, look, this is in our alley to be talking about something with a cool mechanism like this, albeit very specific to the liver in our case. And so yes, we have some -- we have those targets that will increase as well. Anything else read to with that? Or is that -- does that answer it for you?
正如我所說,重點是肝病學家和胃腸病學家。我們也討論了內分泌學家,但我們將繼續尋找更多有興趣的內分泌學家。有趣的是,內分泌學家對作用機制非常感興趣。而這是一個 THR-beta,他們的眼睛亮了起來,說,看,這是我們擅長的,可以討論具有如此酷的機制的東西,儘管在我們的案例中它只針對肝臟。是的,我們有一些——我們的目標也會增加。還有什麼與之相關的讀物嗎?或者說——這能解答你的疑問嗎?
Ritu Baral - Analyst
Ritu Baral - Analyst
And that covers it.
就這樣吧。
Operator
Operator
Akash Tewari, Jefferies.
Akash Tewari,傑富瑞。
Unidentified Participant
Unidentified Participant
This is Kathy on for Akash. To follow on the gross to net question from before. I know you said you'll see more of the contracting happen in the second half of the year. But based on our math, it looks like the gross-to-net for this quarter roughly returned to Q4 levels.
我是 Kathy,代表 Akash。接下來是前面關於總額到淨額的問題。我知道您說過您會看到下半年出現更多的合約簽訂。但根據我們的計算,本季的毛利率似乎大致恢復到了第四季的水平。
And then we also anticipated a potentially higher Part D impact from this quarter versus last quarter. So what are the biggest drivers behind this price improvement for the quarter and can you give us some color on the Part D redesign impact this quarter as well as the stocking contribution and the driving factors behind that increase?
然後,我們也預計本季 D 部分的影響可能會比上一季更大。那麼本季價格上漲的最大驅動因素是什麼?您能否向我們介紹本季 D 部分重新設計的影響以及庫存貢獻和價格上漲背後的驅動因素?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Thanks for the question. There was a lot -- a couple of thrown in there. I'm not sure we can get to. But Mardi, any comments?
謝謝你的提問。有很多——有幾件被扔在那裡。我不確定我們能否到達。但是 Mardi,有什麼評論嗎?
Mardi Dier - Chief Financial Officer, Executive Vice President
Mardi Dier - Chief Financial Officer, Executive Vice President
So let's start on the easy one on stocking, which was not part of gross to net, as you know, but let's reiterate what we said in the script as well. It was a strong demand quarter. And so inventory is not we don't need to discuss that anymore -- strong demand quarter. With respect to gross to net, a lot of focus here. Let's reiterate.
因此,讓我們從簡單的庫存開始,正如你所知,它不是毛利到淨利的一部分,但讓我們重申一下我們在腳本中所說的內容。這是一個需求強勁的季度。因此,我們不再需要討論庫存問題——強勁的需求季度。關於總額與淨額,這裡有許多關注點。我們再重申一下。
So again, the range that has been brought up on this call already for typical specialty medicines at this point in the launch for this year is 20% to 30%. And -- what we've said is that contracting, which is one component of many components in gross to net, we'll see a bigger -- started in April, normal part of our business, and we'll continue to widen that through the end of the year.
因此,再次強調,本次電話會議中已經提出的今年上市典型特種藥物的佔比範圍是 20% 至 30%。而且 - 我們說過的是,合約是總額與淨額之間眾多組成部分之一,我們將看到合約規模更大 - 從四月份開始,這是我們業務的正常部分,我們將繼續擴大合約規模,直到年底。
So that's all predictable in that 20% to 30% range and expected. In Part B, I thought we kind of put this to bed, but the Part D impact was wins we discussed this on the fourth quarter, and I believe the first quarter call, which is incremental to what we saw in the fourth quarter.
因此,這一切都在 20% 到 30% 的範圍內,是可以預測的,也是預料之中的。在 B 部分中,我認為我們已經解決了這個問題,但 D 部分的影響是勝利,我們在第四季度討論了這個問題,我相信第一季度的電話會議與我們在第四季度看到的情況相比有所增加。
And that's because we had rebates in the fourth quarter, given the timing of our launch -- so the new IRA Part D impact was pretty minimal going into 2025, given the base from which we started in the fourth quarter of -- all in all, so gross to net, again, falls within the range, and we'll continue to do so through the rest of 2025.
這是因為,考慮到我們推出的時間,我們在第四季度獲得了回扣——因此,考慮到我們在第四季度開始的基礎,新的 IRA Part D 對 2025 年的影響非常小——總而言之,總額與淨額再次處於範圍內,我們將在 2025 年剩餘時間內繼續這樣做。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Yeah. And look, I mean, we were clear on our first approval call that we would have a choppy gross to net to net for a period of time. But just what happens in the launch. And just to reiterate again, there are a number of components of gross net, including co-pay assistance. I mean, we have a $0 co-pay assistance program as well, which is getting -- greater and greater utilization. It's really important. We want patients on co-pay assistance because that just makes it more affordable, which leads to better persistency leads to better outcomes for patients.
是的。我的意思是,我們在第一次批准電話會議上就明確表示,在一段時間內,我們的總收入與淨收入之間會出現波動。但發射時究竟發生了什麼事。再次重申一下,總淨額由多個組成部分組成,其中包括共同支付援助。我的意思是,我們還有一個 0 美元的共同支付援助計劃,該計劃的利用率正在越來越高。這真的很重要。我們希望患者能夠獲得共同支付援助,因為這樣可以更負擔得起治療費用,從而提高堅持性,為患者帶來更好的治療結果。
Operator
Operator
Mayank Mamtani, B.Riley Securities.
Mayank Mamtani,B.Riley 證券。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
Congrats on a very strong quarter. Could you give us a little bit more detail on the claims of this newly issued patent with 2045 expiry. I guess it's related to the method of treating NASH where those finding work in humans was a nonobvious finding. And also was curious if there's plans to further build on this with the outcomes data emerging? And then I have a quick follow-up.
恭喜本季業績表現強勁。您能否向我們詳細介紹這項新頒發、有效期為 2045 年的專利的權利要求。我猜想這與治療 NASH 的方法有關,而那些在人類身上發現的方法並不明顯。並且很好奇是否有計劃根據出現的結果數據進一步發展這一計劃?然後我有一個快速的跟進。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Sorry, what was the F4c question? I missed that.
抱歉,F4c 問題是什麼?我錯過了。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
Yeah, there's additional patent work you may do as the F4c and the outcomes data still emerging there?
是的,您可以做額外的專利工作,因為 F4c 和結果數據仍然在那裡出現?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Yeah, great. That's something we, we don't have the trial outcome yet. We don't have approval yet. Certainly, there will be -- we'll look for opportunities with the F4c indication, we hope, in the future. But look, I think the pattern you saw this morning or you are -- it's available now. And as we said, it's based on clear and compelling evidence that different -- different doses given two different cohorts of patients, each comprising different body waste optimizes the efficacy of safety of efficacy and safety over recipe. So that's the headline for it.
是的,很棒。這是我們尚未得到審判結果的事。我們尚未獲得批准。當然會有──我們希望將來能利用 F4c 指示來尋找機會。但是你看,我認為你今天早上看到的模式或你現在看到的模式——現在就可以使用了。正如我們所說,它是基於明確而令人信服的證據,即對兩組不同的患者(每組包含不同的身體廢物)使用不同的劑量可以優化療效和安全性,而不是處方安全性。這就是它的標題。
We think this is a very strong patent. This is something that has become our base case now. as we think about all of our planning in the company and how we're thinking about our plans for everything from BD to just investment, et cetera, 2045 is our base case.
我們認為這是一項非常強大的專利。這已經成為了我們現在的基本情況。當我們考慮公司的所有規劃以及我們如何考慮從 BD 到投資等所有事項的計劃時,2045 就是我們的基準情況。
So look, I think I'm going to let you all spend a little bit more time reading it and so forth. But we think all the facts are very clear. We think that there's good precedent as well in case law, and we're really excited about this. This is a really, really, really important development for us as a company.
所以,我想我會讓你們花更多的時間閱讀它等等。但我們認為所有事實都非常清楚。我們認為判例法中也有很好的先例,我們對此感到非常興奮。對我們公司來說,這是一個非常非常非常重要的發展。
Operator
Operator
Jay Olson, Oppenheimer.
傑伊·奧爾森,奧本海默。
Jay Olson - Analyst
Jay Olson - Analyst
Congrats on the quarter and all the impressive progress, especially with life cycle planning. In your due diligence process, can you talk about any preclinical or clinical work done to support a fixed-dose combination of SYH-2086 with Rezdiffra. And now that you have an oral GLP-1 what other mechanisms are you considering? And how are you thinking about future business development deals in terms of timing and priority?
恭喜本季取得的所有令人印象深刻的進展,特別是在生命週期規劃方面。在您的盡職調查過程中,您能否談談為支持 SYH-2086 與 Rezdiffra 的固定劑量組合而進行的任何臨床前或臨床工作。現在您有了口服 GLP-1,您還在考慮哪些機制?您如何考慮未來業務發展交易的時間和優先順序?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Great. Thanks, Jay. Maybe I'll start with just the last bit and then I'll turn it over to Dave.
偉大的。謝謝,傑伊。也許我會從最後一點開始,然後將其交給戴夫。
Look, BDs are still very much part of our strategy. We think this is a great first step, but we will continue to look at next best mechanisms of action that are going to add potential value to MASH patients. either as a stand-alone or in combination with Rezdiffra.
你看,BD 仍然是我們策略的重要組成部分。我們認為這是很好的第一步,但我們將繼續尋找下一個最佳作用機制,為 MASH 患者增加潛在價值。無論是單獨使用還是與 Rezdiffra 結合使用。
Now we really believe that the market is going to move towards combination therapy and that Rezdiffra is going to be the foundational therapy. It already is. It's the standard of care today. And what you see in a lot of different diseases is that you add to that standard of care, whether it be for a different effect you're looking for, a subpopulation, et cetera.
現在我們確實相信市場將轉向聯合療法,而 Rezdiffra 將成為基礎療法。已經如此了。這是當今的護理標準。在許多不同的疾病中,你會看到,你會在該護理標準上做出改變,無論是為了尋求不同的效果,還是針對亞群等等。
Remember, we are at the absolute very beginning, 7% penetrated into this 315,000 population with decades, I would say, of growth in this marketplace ahead of us, it's going to support multiple mechanisms of action, multiple products. And as the leader with the foundational product looking for those next white spaces or areas of opportunity is something that we are going to be a part of and more than that we are going to drive.
請記住,我們處於絕對的起步階段,7% 的市場份額已經滲透到 315,000 人口中,我想說,未來幾十年這個市場將繼續增長,它將支持多種作用機制和多種產品。作為基礎產品的領導者,我們將致力於尋找下一個空白領域或機會領域,並為此做出更多努力。
So Dave, maybe you want to talk a little bit about this asset?
那麼戴夫,也許你想談談這項資產?
David Soergel - Executive Vice President, Chief Medical Officer
David Soergel - Executive Vice President, Chief Medical Officer
Yeah, sure. I think first of all, let's touch on two things. First of all, the scientific rationale for combining a GLP-1 with first [Metron]. And then second, we can talk about this molecule in particular. So we already know based on our experience in Maestro NASH that as little as 5% weight loss will enhance the efficacy of resmetirom in NASH. So we see better biopsy results in patients who achieve as little as 5% weight loss.
是的,當然。我認為首先讓我們談兩件事。首先,將 GLP-1 與第一[地鐵]。其次,我們可以具體討論一下這個分子。因此,根據我們在 Maestro NASH 方面的經驗,我們已經知道,僅僅 5% 的體重減輕就會增強 resmetirom 在 NASH 中的療效。因此,我們看到體重減輕僅 5% 的患者活檢結果更好。
So as we talked about, we can achieve that more effectively and in more patients, that level of weight loss with -- by adding a GLP-1 mechanism drug to Rezdiffra. So the sign of rationale, I think is very, very strong for combining the mechanisms. Second, with respect to this molecule, in particular, Bill touched on some of the properties that we were looking for. We were looking for chemical properties like the structure.
因此,正如我們所討論的,透過在 Rezdiffra 中添加 GLP-1 機制藥物,我們可以更有效地讓更多患者達到這種減肥水平。因此,我認為結合這些機制的理由非常充分。其次,關於這種分子,比爾特別提到了我們正在尋找的一些特性。我們正在尋找像結構這樣的化學特性。
We wanted to make sure that came with a derisked structure like an Orforglipron backbone. And we wanted to make sure that the pharmacokinetics and initial pharmacology were consistent with what we were seeing with other molecules in this class.
我們希望確保它具有像 Orforglipron 骨架一樣的低風險結構。我們希望確保藥物動力學和初始藥理學與我們在該類別中看到的其他分子一致。
So that gave us that assessment, I think it's important to sort of mention that this is still a preclinical asset, and there's still work to be done before we get into the clinic. But from what we've seen, we're very excited about combining 2086 with Rezdiffra.
所以這給了我們這樣的評估,我認為有必要指出這仍然是一個臨床前資產,在進入臨床之前還有一些工作要做。但從我們所看到的情況來看,我們對將 2086 與 Rezdiffra 結合感到非常興奮。
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
And maybe just one final point on that, Jay. Fixed dose combo would be great, but it's not completely necessary. And again, I think that you have to go back to when you've got the runway that we've got to 2045, right? We had the time to do things in a very thoughtful, precise way. Ideally, it's a fixed-dose combo, but it doesn't have to be just be more convenient for patients. But we like the properties that would make that a good probability.
關於這一點,也許我只想說最後一點,傑伊。固定劑量組合會很棒,但這不是完全必要的。再說一次,我認為你必須回到我們已經擁有的 2045 年跑道時代,對嗎?我們有時間以非常周到、精確的方式做事。理想情況下,它是一種固定劑量的組合,但它不一定只是對患者更方便。但我們喜歡那些能使其成為一個很好的可能性的屬性。
Tina Ventura - Chief Investor Relations
Tina Ventura - Chief Investor Relations
Thanks so much, Jay. And Deb, it looks like we have time for one more question, please.
非常感謝,傑伊。黛布,看來我們還有時間再回答一個問題。
Operator
Operator
Kaveri Pohlman, Clear Street.
卡弗里‧波爾曼 (Kaveri Pohlman),《清晰街》。
Kaveri Pohlman - Analyst
Kaveri Pohlman - Analyst
Congrats on the progress. I just want to kind of understand a little bit about the competitive landscape and your rationale for choosing GLP-1s over there are a lot of dual and triple agonist going on? And how you are thinking about whether with increase in weight loss, if you can see more benefit to MASH patients?
恭喜你取得進展。我只是想了解一下競爭格局,以及您選擇 GLP-1 的理由,市面上有很多雙重和三重激動劑?您認為隨著體重減輕,MASH 患者是否能獲得更多益處?
And you expect any off-label use there as this space grows as well as with the combination specifically for the oral drug you have -- any concerns related to kind of overlapping toxicities. And based on that, how you are thinking about developing it whether you plan to -- when you like test different doses and scheduling of both drugs or GLP-1 will be adjusted according to the approved regimen for Rezdiffra?
隨著這個領域的發展以及特別是針對口服藥物的組合,您預計會出現任何標籤外使用的情況——任何與重疊毒性相關的擔憂。基於此,您如何考慮開發它,您是否計劃——當您喜歡測試兩種藥物的不同劑量和時間安排時,或者 GLP-1 將根據 Rezdiffra 的批准方案進行調整?
Bill Sibold - President, Chief Executive Officer, Director
Bill Sibold - President, Chief Executive Officer, Director
Great. Well, thank you. I appreciate the question. There's a lot there. Let me just take a couple of things really quickly. First of all, we like oral GLP-1 for the reasons Dave mentioned and that we mentioned in the call, with as little as a 5% weight loss in combination with Rezdiffra, we see a better effect on fibrosis from Rezdiffra.
偉大的。好的,謝謝你。我很感謝你提出這個問題。那裡有很多東西。讓我快速講幾件事。首先,我們喜歡口服 GLP-1,原因如 Dave 和我們在電話會議中提到的,與 Rezdiffra 結合使用,體重減輕僅 5%,我們就能看到 Rezdiffra 對纖維化有更好的效果。
So that makes it better. Now you're talking about a whole group of products, BGGs, et cetera, where their fundamental approach is the battle of who can show the greatest weight loss -- and there's comparisons of 1%, 2% in the teens and beyond, and that becomes a competitive set. That's not the game we're playing.
這樣就更好了。現在你談論的是一組產品,BGG 等等,它們的基本方法是看誰能實現最大的減肥效果——並且有 1%、2% 以及更高水平的比較,這就形成了一個競爭力。這不是我們正在玩的遊戲。
We need an oral GLP-1 that gets us past that 5%, but it's well tolerated. It's something that people can stay on so that the overall profile of the new product with Rezdiffra remains what it is which is really as good as it gets in the profile of the drug. It's a holy grail profile, once a day pill, something we've been looking for in my whole career, our products like this.
我們需要一種口服 GLP-1,可以讓我們超過 5%,但耐受性良好。人們可以繼續使用它,這樣 Rezdiffra 新產品的整體特性就可以保持原樣,並且與藥物特性一樣好。這是一種聖杯般的產品,每天服用一次,這是我整個職業生涯中一直在尋找的東西,我們的產品就是這樣的。
So we have a very different approach on how we're thinking about this. The primary objective isn't for massive weight loss. The primary objective is to get to this threshold weight loss that makes Rezdiffra perhaps an even better drug. So that's a different frame.
因此,我們對這個問題的思考方式非常不同。主要目標不是大量減肥。主要目標是達到這個減肥閾值,這使得 Rezdiffra 成為更好的藥物。所以這是一個不同的框架。
And I think people got to get their head around that because that's how we very thoughtfully approach this. As it relates to what's the impact on the product profile, as I said, we're trying to make it a well-tolerated profile and not give up anything on it. And that's how we hope to satisfy that with dosing, et cetera. But it's premature to talk about our development plan. We're going to come back at a later time. And as I said as well, BD remains part of our strategy, and it's something that will be -- continue to be very thoughtful about how we might extend our leadership in MASH. And Dave --
我認為人們必須理解這一點,因為這就是我們深思熟慮地處理這個問題的方式。至於它對產品概況的影響,正如我所說,我們正在努力使其成為一個具有良好耐受性的概況,並且不會放棄任何東西。這就是我們希望透過劑量等方式來滿足這項要求的方法。但現在談論我們的發展計劃還為時過早。我們稍後再回來。正如我所說的,BD 仍然是我們策略的一部分,我們將繼續認真考慮如何擴大我們在 MASH 中的領導地位。還有戴夫--
David Soergel - Executive Vice President, Chief Medical Officer
David Soergel - Executive Vice President, Chief Medical Officer
I would just add one thing with respect to the diligence on the molecule. So of course, one of the things that we were looking at was the preclinical profile and ensuring that this molecule would be, at least from a preclinical standpoint, compatible with risk metro. And so we were reassured by our diligence process. And so we're very excited to have this and tested in clinics.
關於分子的勤奮,我只想補充一點。因此,當然,我們正在關注的事情之一是臨床前概況,並確保這種分子至少從臨床前的角度來看與風險地鐵相容。因此,我們對我們的盡職調查過程感到放心。因此,我們非常高興能夠在臨床上進行此項測試。
Tina Ventura - Chief Investor Relations
Tina Ventura - Chief Investor Relations
Thanks, Dave. And thanks, everyone. Thanks, Demi and thank you all for your time and interest today. This now concludes our call. A replay of this webcast will be available on our website in about two hours. Thank you for joining us.
謝謝,戴夫。謝謝大家。謝謝,黛米,也謝謝大家今天的時間和關注。我們的通話到此結束。這個網路廣播的重播將在大約兩小時後在我們的網站上提供。感謝您加入我們。
Operator
Operator
And gentlemen, thank you for your participation in today's conference. You may now disconnect. Have a wonderful day.
先生們,感謝你們參加今天的會議。您現在可以斷開連線。祝您有美好的一天。