Madrigal Pharmaceuticals Inc (MDGL) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to Madrigal Pharmaceuticals first quarter 2025 earnings conference call. (Operator Instructions) As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

您好，感謝您的支持。歡迎參加 Madrigal Pharmaceuticals 2025 年第一季財報電話會議。（操作員指示）提醒一下，今天的電話會議正在被錄音。現在我想介紹首席投資者關係官蒂娜·文圖拉女士。請繼續。

Thank you, Tawana. Good morning, everyone, and thank you for joining us to discuss Madrigal's first quarter 2025 earnings. We issued a press release this morning and I have a slide deck that accompanies this webcast, which we'll post on the investor relations section of our website right after the call.

謝謝你，塔瓦娜。大家早安，感謝您加入我們討論 Madrigal 2025 年第一季的收益。我們今天早上發布了一份新聞稿，我有一個與這次網路廣播配套的幻燈片，我們將在電話會議結束後立即將其發佈在我們網站的投資者關係部分。

On the call with me today is Bill Sibold, Chief Executive Officer; and Mardi Dier, Chief Financial Officer. They'll provide prepared remarks, and then we'll take your questions. We plan to keep today's call to about 45 minutes.

今天與我一起通話的是執行長比爾·西博爾德 (Bill Sibold)；以及財務長 Mardi Dier。他們會提供準備好的發言，然後我們會回答您的問題。我們計劃將今天的通話時間控制在 45 分鐘左右。

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.

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。說完這些，我現在會把電話轉給幻燈片 3 上的比爾。

Thanks, Tina. Good morning and thanks for joining. Today I'll provide an update on the significant momentum we continue to build with the US launch of Rezdiffra. I'll briefly recap the impressive two year F4c data we shared on our last earnings call, which has since been selected as a late breaking oral presentation at the EASL Congress in Amsterdam next week. We plan to review this data in an investor webcast following EASL on Tuesday, May 13, and I'll close with the review of our strategy to expand our leadership position in MASH.

謝謝，蒂娜。早安，感謝您的加入。今天，我將向您介紹我們在美國推出 Rezdiffra 後繼續保持的強勁勢頭。我將簡要回顧我們在上次收益電話會議上分享的令人印象深刻的兩年 F4c 數據，該數據已被選為下週在阿姆斯特丹舉行的 EASL 大會的最新口頭報告。我們計劃在 5 月 13 日星期二 EASL 之後的投資者網路廣播中審查這些數據，最後我將審查我們擴大在 MASH 領導地位的策略。

But before we move to the quarter, I want to take a moment to recognize Becky Taub, Madrigal's founder and a driving force behind the development and ultimate approval of Rezdiffra. As we announced in April, Becky is taking on the new role of senior scientific and medical advisor, and she will continue to serve on our board of directors. And we are very pleased that Dave Soergel joined us on April 21 as our new Chief Medical Officer succeeding Becky.

但在我們進入本季之前，我想花點時間認識貝基·陶布 (Becky Taub)，她是 Madrigal 的創始人，也是 Rezdiffra 開發和最終批准的推動力。正如我們在四月宣布的那樣，貝基將擔任高級科學和醫學顧問的新職務，並且她將繼續擔任我們的董事會成員。我們非常高興 Dave Soergel 於 4 月 21 日加入我們，接替 Becky 擔任新任首席醫療官。

Becky's vision, pioneering work, and relentless drive led to the development and approval of the first ever FDA approved medicine for MASH. This is a landmark achievement in our industry and one that has already changed the lives of thousands of patients. It's also changed Madrigal. We've transformed from an R&D focused company to a fully integrated commercial stage organization.

貝基的遠見、開創性的工作和不懈的努力促成了 FDA 批准的第一種 MASH 藥物的開發和批准。這是我們行業的一個里程碑式的成就，它已經改變了成千上萬患者的生活。它也改變了 Madrigal。我們已經從一家專注於研發的公司轉型為完全整合的商業階段組織。

Dave brings more than 20 years of leadership experience in metabolic and cardiovascular disease drug development spanning both biotech and large pharma. He was most recently the EVP and Global Head of Cardiovascular, Renal, and Metabolism Development at Novartis, where he was overseeing 10 late stage clinical development programs. We believe Dave is the right leader to take the reins at this critical juncture and build on the foundation Becky created.

Dave 擁有超過 20 年的代謝和心血管疾病藥物開發領導經驗，涉及生物技術和大型製藥領域。他最近擔任諾華公司的執行副總裁兼心血管、腎臟和代謝開發全球主管，負責監督 10 個後期臨床開發項目。我們相信戴夫是合適的領導者，能夠在這個關鍵時刻掌舵並在貝基奠定的基礎上繼續前進。

Along those lines, I'd also like to highlight the recent addition to our Board of Directors, Jackie Fouse. Jackie brings a depth of experience from her leadership roles at several successful biotechs, including Agios and Celgene. I look forward to working with her as we continue to grow the company.

本著這個精神，我還想特別提到我們董事會最近新加入的成員 Jackie Fouse。Jackie 在多家成功的生技公司（包括 Agios 和 Celgene）擔任領導職務，擁有豐富的經驗。我期待與她合作，共同推動公司不斷發展。

Now let's turn to slide 4 and Rezdiffra's first quarter 2025 performance. We're a little more than 12 months into the launch of Rezdiffra and what a difference a year makes.

現在讓我們翻到投影片 4 和 Rezdiffra 2025 年第一季的業績。Rezdiffra 推出至今已有 12 個多月了，這一年發生了巨大的變化。

We've gone from zero approved MASH treatments and no market infrastructure to securing FDA approval in March 2024, launching with the best case label and a world class team, achieving over 80% commercial payer coverage, helping lay the foundation practice by practice to build the infrastructure required for patient treatment, treating more than 17,000 patients who previously had no options, and generating $317 million in net sales in our first 12 months on the market.

我們從零個核准的 MASH 治療方法和沒有市場基礎設施​​，到 2024 年 3 月獲得 FDA 批准，以最佳案例標籤和世界一流的團隊推出產品，實現超過 80% 的商業付款人覆蓋率，幫助透過實踐奠定基礎，建立患者治療所需的基礎設施，治療了超過 17,000 名銷售額的前 17 億美元，並在 27272 272 月的淨銷售額前創造了 17 億美元。

By any measure, this is an exceptional launch. And we know that because we're benchmarking ourselves against some of the most successful specialty medicine launches in the past decade. Whether it's patient growth, depth, and breadth of prescribing, payer coverage, or net sales, we're performing at or near the top. But the most exciting part, we're just getting started. As we enter year two, we're bringing the same intensity and focus on execution that got us here, and we believe the best is still ahead.

無論以何種標準衡量，這都是一次非凡的發布。我們之所以知道這一點，是因為我們以過去十年中最成功的一些專科藥物上市作為標竿。無論是患者成長、處方深度和廣度、付款人覆蓋範圍或淨銷售額，我們的表現都處於或接近頂級水平。但最令人興奮的是，我們才剛開始。進入第二年，我們仍將以同樣的力量和專注力來執行，我們相信最好的還在後頭。

This momentum carried us into another impressive quarter with first quarter 2025 net sales of $137 million up 33% quarter over quarter, despite the typical headwinds we see in Q1 across the industry.

這一勢頭使我們進入了另一個令人印象深刻的季度，儘管我們在第一季度看到了整個行業典型的逆風，但 2025 年第一季的淨銷售額仍達 1.37 億美元，環比增長 33%。

Our patients support and field teams did a great job navigating those dynamics to keep patients on therapy, and we're continuing to generate strong demand and steadily add patients into the second quarter, driven by the urgent need re differ addresses, its compelling product profile, and the exceptional execution of our team.

我們的患者支援和現場團隊在引導這些動態以讓患者繼續接受治療方面做得非常出色，並且我們將繼續產生強勁的需求並穩步增加第二季度的患者數量，這得益於對不同地址的迫切需求、其引人注目的產品形像以及我們團隊的出色執行力。

In addition to net sales, we continue to make great progress on key performance indicators that are driving our launch. First on patients as shown on slide 5, we ended the first quarter of 2025 with more than 17,000 patients on Rezdiffra, up from 11,800 patients at the end of the fourth quarter of 2024.

除了淨銷售額之外，我們在推動產品上市的關鍵績效指標方面也持續取得巨大進步。首先從投影片 5 所示的患者情況來看，截至 2025 年第一季末，使用 Rezdiffra 的患者超過 17,000 名，高於 2024 年第四季末的 11,800 名患者。

This figure represents patients actively on therapy, accounting for any discontinuations, making it the most rigorous and meaningful metric to track sustained treatment adoption.

這個數字代表積極接受治療的患者，考慮到任何中斷治療的情況，使其成為追蹤持續治療採用的最嚴格和最有意義的指標。

And when we compare it to other top tier specialty launches, we're adding patients at a rate that's consistent with those benchmarks. And yet we're still in the very early innings of this launch. Only about 5% of the 315,000 diagnosed F2/F3 MASH patients who are currently under the care of our target prescribers are being treated with Rezdiffra.

當我們將其與其他頂級專科項目進行比較時，我們發現我們增加患者的速度與這些基準一致。然而，我們仍處於此次發布的早期階段。在我們目標處方醫生目前治療的 315,000 名確診為 F2/F3 MASH 的患者中，只有約 5% 接受 Rezdiffra 治療。

We also see that awareness is driving action. Our disease and product education efforts are preparing patients to have better conversations with their MASH specialists about their care.

我們也看到，意識正在推動行動。我們的疾病和產品教育工作正在幫助患者更好地與 MASH 專家討論他們的護理。

We remain focused on those 315,000 patients, which represents a highly attractive specialty market. Looking ahead, the stated efforts of the next entrant are focused on expanding the market to many multiples of our initial target market.

我們仍然關注這 315,000 名患者，這代表著一個極具吸引力的專業市場。展望未來，下一個進入者所做的努力將集中在將市場擴大到我們最初目標市場的數倍。

We believe that the strength of Rezdiffra's efficacy and attractive real world profile positions it for leadership in either scenario, creating multiple paths to success for Rezdiffra in the years ahead.

我們相信，Rezdiffra 的功效和有吸引力的現實世界形象使其在兩種情況下都佔據領導地位，為 Rezdiffra 在未來幾年取得成功創造了多條道路。

Moving to slide 6 in our progress on physician penetration. Across the many launches I've led, one thing is clear building a strong base of prescribers early in a launch is one of the best indicators of long-term success. That's why the pace at which we've added new prescribers has been so encouraging. In just a year since approval, 70% of our 6,000 top targets have prescribed Rezdiffra.

轉到投影片 6，了解醫生滲透的進展。在我領導的眾多產品發布過程中，有一點是明確的：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。這就是為什麼我們增加新處方者的速度如此令人鼓舞。自批准以來僅一年時間，我們 6,000 名主要治療對像中就有 70% 服用了 Rezdiffra。

This level of penetration puts us at the high end of the benchmarks we track and shows we've built a strong foundation of healthcare providers who believe in Rezdiffra and are seeing the benefits.

這種滲透水平使我們處於所追蹤基準的高端，並表明我們已經建立了強大的醫療保健提供者基礎，他們相信 Rezdiffra 並看到了其好處。

Achieving this type of uptake this quickly is the result of the work we've been doing since day one. Wiring the system for a first in disease launch like Rezdiffra is no small feat. We built and deployed a world class team. We educated physicians on a disease that had no approved therapies.

如此迅速地實現這種吸收是我們從第一天起就一直在努力的結果。為 Rezdiffra 這樣的首次疾病治療藥物啟動系統佈線絕非易事。我們建立並部署了一支世界一流的團隊。我們向醫生們解釋了一種尚無批准療法的疾病。

We partnered with payers to secure broad access and worked hand in hand with practices to help create the infrastructure needed to support sustained prescribing. As a result, more and more practices are integrating red differ into their standard of care.

我們與付款人合作以確保廣泛的訪問，並與實踐攜手幫助創建支持持續處方所需的基礎設施。因此，越來越多的實踐將紅色差異融入他們的護理標準中。

We're driving the same momentum as we establish a strong base within our 14,000 total targets to support the significant peak sales potential we expect.

我們正在保持同樣的勢頭，在 14,000 個總目標內建立強大的基礎，以支持我們預期的巨大峰值銷售潛力。

At the end of the first quarter of 2025, approximately 50% of the 14,000 target prescribers had prescribed Rezdiffra, up from 40% at the end of the fourth quarter of 2024, reflecting a growing and durable foundation. Our in-office support and cross-functional field engagement are not only driving breadth, they're also driving depth. We are steadily turning new writers into repeat prescribers and seeing more prescriptions written per provider. That has consistently increased quarter over quarter as well.

截至 2025 年第一季末，14,000 名目標處方者中約有 50% 處方了 Rezdiffra，高於 2024 年第四季末的 40%，反映出基礎不斷增長且持久。我們的辦公室支援和跨職能現場參與不僅推動了廣度，也推動了深度。我們正在穩步地將新開藥者轉變為重複開藥者，並且看到每個提供者開出的處方越來越多。這一數字也逐季持續成長。

Rezdiffra's broad uptake is being driven by its attractive real world profile. A medicine's profile often diminishes once it enters real world.

Rezdiffra 的廣泛普及得益於其極具吸引力的現實世界形象。一旦藥物進入現實世界，其知名度往往會降低。

With Rezdiffra, we hear the opposite. Physicians and patients continue to highlight meaningful improvements they see on the efficacy measures that matter most to patients, such as liver stiffness, liver fat, liver enzymes, LDL, and triglycerides.

而對於 Rezdiffra，我們聽到的卻恰恰相反。醫生和患者繼續強調他們在對患者最重要的療效指標上看到的有意義的改善，例如肝臟硬度、肝臟脂肪、肝臟酵素、低密度脂蛋白和三酸甘油酯。

And our Phase 3 data demonstrate that res differ halts or improved liver stiffness in 91% of patients. As a once daily, well tolerated pill with simple dosing, it's also easy to take. We're seeing strong early signs of adherence with rates that are comparable to other well tolerated oral therapies.

我們的第 3 階段數據表明，91% 的患者的肝硬度已停止或改善。作為一種每日一次、耐受性良好、劑量簡單且服用方便的藥丸。我們看到了強烈的早期依從跡象，其依從性與其他耐受性良好的口服療法相當。

We believe Rezdiffra's liver-directed mechanism, strong efficacy, and attractive real world profile will translate well from F2/F3 MASH patients to those with F4c or compensated mash cirrhosis, as noted on slide 8.

我們相信，Rezdiffra 的肝臟導向機制、強大的療效和有吸引力的現實世界概況將很好地從 F2/F3 MASH 患者轉化為 F4c 或代償性麥芽漿肝硬化患者，如幻燈片 8 所示。

As MASH progresses, it can lead to cirrhosis marked by significant liver damage, loss of liver function, liver cancer, and death. Many F4c patients are also experiencing clinically significant portal hypertension, or CSPH, a major consequence of cirrhosis that's responsible for its most severe complications, such as ascites, variceal bleeding, and hepatic encephalopathy.

隨著 MASH 的進展，它會導致肝硬化，其特徵是嚴重的肝損傷、肝功能喪失、肝癌和死亡。許多 F4c 患者也會出現臨床上顯著的門靜脈高壓（CSPH），這是肝硬化的主要後果，是導致腹水、靜脈曲張出血和肝性腦病變等最嚴重併發症的原因。

The risk of progression is striking. F2/F3 patients face a 10 to 17-fold increase in liver-related mortality compared to patients without fibrosis. For F4, that number jumps to a 42-fold increase. That's why we are evaluating Rezdiffra in 845 F4c patients in MAESTRO-NASH OUTCOMES, a large Phase 3 double blind placebo controlled trial evaluating progression to liver decompensation. We expect data from this trial in 2027.

病情進展的風險是驚人的。與未患纖維化的患者相比，F2/F3 患者的肝臟相關死亡率增加 10 至 17 倍。對於 F4，這個數字躍升至 42 倍。這就是為什麼我們在 MAESTRO-NASH OUTCOMES 中對 845 名 F4c 患者進行 Rezdiffra 評估，這是一項評估肝臟失代償進展的大型 3 期雙盲安慰劑對照試驗。我們預計該試驗的數據將於 2027 年公佈。

Last quarter we shared two year data from the open label active treatment arm of our MAESTRO-NAFLD-1 trial in F4c patients. These results demonstrated Rezdiffra's ability to reduce liver stiffness, a key predictor of adverse liver-related events.

上個季度，我們分享了針對 F4c 患者的 MAESTRO-NAFLD-1 試驗的開放標籤活性治療組的兩年數據。這些結果證明了 Rezdiffra 能夠降低肝臟硬度，而肝硬度是肝臟相關不良事件的關鍵預測指標。

Turning to slide 9, let me quickly recap the two primary efficacy findings. Patients saw a mean reduction of 6.7 kilopascals in liver stiffness at two years, which was statistically significant as compared to baseline. For context, physicians use the Baveno Rule of 5 to stratify risk in MASH cirrhosis, so a 6.7 kPa reduction suggests that many patients are moving into a lower risk category.

翻到投影片 9，讓我快速回顧兩個主要的功效發現。兩年後，患者的肝臟硬度平均降低了 6.7 千帕，與基線相比具有統計學意義。就背景而言，醫生使用 Baveno 5 規則對 MASH 肝硬化的風險進行分層，因此 6.7 kPa 的降低表明許多患者正在進入較低的風險類別。

51% of patients achieved a greater than or equal to 25% reduction in liver stiffness. As published in JAMA, This level of reduction is associated with a lower risk of progression to end-stage liver disease, essentially a reversal of cirrhosis.

51% 的患者的肝臟硬度降低了 25% 或更高。正如在《JAMA》上發表的那樣，這種程度的減少與降低進展為終末期肝病的風險有關，本質上是逆轉肝硬化。

These results and additional insights will be presented at the upcoming EASL Congress on May 10 by Dr. Naim Alkhouri, Chief Academic Officer at Summit Clinical Research and the director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio.

這些結果和其他見解將於 5 月 10 日在即將舉行的 EASL 大會上由 Summit Clinical Research 首席學術長兼俄亥俄州臨床研究所脂肪肝計畫主任 Naim Alkhouri 博士介紹。

This abstract was accepted as a late breaking oral presentation, and one of the most important findings will highlight is Rezdiffra's impact to reduce liver stiffness measures and other biomarkers that are linked to a reduction in risk of CSPH. Importantly, CSPH is the cause of many adverse liver-related OUTCOMES that mark the progression from compensated to decompensated cirrhosis. Preventing these devastating outcomes is the central goal of treating liver disease.

該摘要被接受為最新的口頭報告，其中最重要的發現之一是 Rezdiffra 對降低肝臟硬度測量值和其他與降低 CSPH 風險相關的生物標記的影響。重要的是，CSPH 是許多不良肝臟相關結果的原因，這些結果標誌著肝硬化從代償期進展為失代償期。預防這些災難性的後果是治療肝病的核心目標。

As I mentioned earlier, we'll also be hosting a brief investor webcast on May 13 to review the data and discuss the evolving MASH cirrhosis landscape. Dr. Alkhouri will join us for that discussion, and we hope many of you will tune in.

正如我之前提到的，我們還將於 5 月 13 日舉辦一個簡短的投資者網路廣播，以回顧數據並討論不斷變化的 MASH 肝硬化情況。Alkhouri 博士將參加我們的討論，我們希望大家能夠關注。

The expansion to treatment of F4c is a key pillar of our long-term MASH leadership strategy, as shown on slide 10. While we continue to execute a successful US launch in F2, F3, we're advancing efforts to expand Rezdiffra's indication to F4c. Our Phase 3 MAESTRO-NASH OUTCOMES trial is in alignment with FDA guidance for clinical trial design in cirrhosis patients.

如投影片 10 所示，擴大 F4c 的治療是我們長期 MASH 領導策略的重要支柱。在我們繼續成功執行 F2、F3 美國發布的同時，我們正在努力將 Rezdiffra 的適應症擴展到 F4c。我們的 3 期 MAESTRO-NASH OUTCOMES 試驗符合 FDA 針對肝硬化患者臨床試驗設計的指導。

We expect to have data years ahead of the competition and first mover advantage in this segment of the market as well. If approved, this could potentially double Rezdiffra's market opportunity. We're also preparing to bring red differ to patients outside the US. We remain on track for a mid-year regulatory decision in Europe. And if we receive a positive outcome, we plan to launch in Germany in the second half of the year.

我們期望在數據方面領先競爭對手數年，並在此市場領域佔據先發優勢。如果獲得批准，這可能會使 Rezdiffra 的市場機會翻倍。我們也準備將紅色差異帶給美國以外的患者。我們仍在按計劃進行歐洲年中監管決策。如果我們獲得正面的結果，我們計劃在今年下半年在德國推出該產品。

Beyond Europe, we're evaluating additional high priority global markets. At the same time, we're focused on building the right pipeline beyond Rezdiffra. We're in the enviable position of delivering a first in disease medicine to patients today, and now we're looking to extend that leadership with a portfolio of differentiated assets.

除了歐洲以外，我們還在評估其他高優先級的全球市場。同時，我們專注於在 Rezdiffra 之外建立正確的管道。我們今天處於令人羨慕的地位，為患者提供首創的疾病藥物，現在我們希望透過差異化資產組合來擴大這一領導地位。

We're actively evaluating opportunities across multiple mechanisms and stages of development, and as I mentioned earlier, we're excited to have Dave Soergel on board as our new Chief Medical Officer to help lead our pipeline development efforts.

我們正在積極評估多種機制和開發階段的機會，正如我之前提到的，我們很高興 Dave Soergel 加入我們的新首席醫療官，幫助領導我們的管道開發工作。

With that, let me briefly recap our first quarter progress on slide 11. We're off to a great start in year two of our launch. We generated $317 million in net sales over the last 12 months and are seeing continued momentum into the second quarter. Physician adoption continues to build with 70% of our 6,000 top targets now prescribing Rezdiffra.

因此，請允許我在第 11 張投影片上簡要回顧我們第一季的進展。我們推出的第二年就有了一個好的開始。過去 12 個月，我們的淨銷售額達到 3.17 億美元，且第二季的勢頭依然強勁。醫生的採用率持續提高，目前我們 6,000 名頂級目標患者中，有 70% 都開出了 Rezdiffra 處方。

We're expanding our leadership in MASH. With compelling two year F4c data, two pivotal OUTCOMES trial underway, and a potential EMA approval on the horizon, we believe Rezdiffra is well on its way to becoming the foundational therapy across F2 to F4c. With that, I'd like to turn it over to Mardi.

我們正在擴大我們在 MASH 的領導地位。憑藉令人信服的兩年 F4c 數據、正在進行的兩項關鍵 OUTCOMES 試驗以及即將獲得 EMA 批准的潛在結果，我們相信 Rezdiffra 有望成為 F2 至 F4c 的基礎療法。說完這些，我想把發言權交給 Mardi。

Yeah, thank you, Bill. Good morning. I just want to take a moment to comment on how Madrigal is positioned in the current macroeconomic environment. We're positioned extremely well. As a commercial stage biotech with a first in disease medicine addressing a serious unmet need, we've built a US-based supply chain. Rezdiffra is manufactured in the US and its intellectual property is also US domiciled.

是的，謝謝你，比爾。早安.我只想花點時間評論一下馬德里加爾在當前宏觀經濟環境中的地位。我們的定位非常有利。作為一家商業階段的生技公司，我們率先在疾病藥物領域解決尚未滿足的嚴重需求，並建立了一條美國供應鏈。Rezdiffra 在美國製造，其智慧財產權也在美國。

Moving to our financial results as noted on slide 12. First quarter of 2025 net sales totaled $137.3 million, up 33% from the fourth quarter of 2024. This was another strong demand quarter with inventory levels well within our expected two to four week range.

如第 12 頁投影片所示，轉到我們的財務結果。2025 年第一季淨銷售額總計 1.373 億美元，較 2024 年第四季成長 33%。這是另一個需求強勁的季度，庫存水準遠在我們預期的兩到四周範圍內。

As we said, we expect gross net to be choppy in the early in the launch, and the team managed through our first quarter very well. In 2025, we expect gross to net discount to increase and step up as we move through the year and as we begun to contract with payers, which is in line with our expectations. Importantly, this is already reflected in our expectations for robust year over year net sales growth in 2025.

正如我們所說，我們預計在發布初期總淨收入會不穩定，但團隊在第一季表現非常好。到 2025 年，隨著我們開始與付款人簽訂合同，我們預計總淨折扣將會增加並逐步提高，這符合我們的預期。重要的是，這已經反映在我們對 2025 年淨銷售額同比強勁增長的預期中。

R&D expenses for the first quarter of 2025 were $44.2 million compared to $71.2 million for the first quarter of 2024. The decrease was primarily due to the change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024 and lower clinical trial cost. Looking ahead, we expect a similar level of R&D spend in 2025 compared to 2024.

2025 年第一季的研發費用為 4,420 萬美元，而 2024 年第一季的研發費用為 7,120 萬美元。下降的主要原因是 FDA 於 2024 年 3 月批准 Rezdiffra 後庫存成本會計變化以及臨床試驗成本降低。展望未來，我們預期 2025 年的研發支出水準將與 2024 年相似。

SG&A expenses for the first quarter of 2025 were $167.9 million compared to $80.8 million in the first quarter of 2024. SG&A expenses increased by $87.1 million primarily due to increases in commercial launch activities for Rezdiffra, including a corresponding increase in headcount and stock compensation expense. Looking ahead, we expect SG&A expenses to increase in 2025, including a step up into the second quarter as we continue to invest in the US launch and prepare for our launch in Europe.

2025 年第一季的銷售、一般及行政費用為 1.679 億美元，而 2024 年第一季為 8,080 萬美元。銷售、一般及行政費用增加了 8,710 萬美元，主要原因是 Rezdiffra 商業發布活動的增加，包括員工人數和股票薪酬費用相應增加。展望未來，我們預計 2025 年銷售、一般及行政費用 (SG&A) 將會增加，其中第二季將有所增加，因為我們將繼續投資於美國市場的推出，並為在歐洲市場的推出做準備。

Turning to our balance sheet, we ended the first quarter of 2025 with $848.1 million in cash, cash equivalents, restricted cash, and marketable securities. With this strong cash position, we continue to be well resourced to support the ongoing launch of Rezdiffra both in the US and our planned launch in Europe in the second half of this year. I'll now turn the call back over to Tina.

回顧我們的資產負債表，截至 2025 年第一季度，我們擁有 8.481 億美元的現金、現金等價物、受限現金和有價證券。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。我現在將電話轉回給蒂娜。

Thanks, Mardi. Let's move into the Q&A portion of the call. Tawana, 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。Tawana，請繼續並提供問答環節的說明。

(Operator Instructions)

（操作員指示）

Eliana Merle, UBS.

瑞銀的 Eliana Merle。

Hey guys, thanks for taking the question and congratulations on the quarter. I'm just curious to go a little bit more in depth on your expectations for the growth trajectory for Rezdiffra, particularly when SEMA's label is expanded to include NASH. Do you expect to see new patients at a similar rate, and can you just elaborate on sort of how you see the growth from there? Thanks.

嘿，大家好，感謝您提出這個問題，並祝賀本季度取得的成績。我只是好奇想更深入地了解您對 Rezdiffra 成長軌蹟的預期，特別是當 SEMA 的標籤擴展到包括 NASH 時。您是否預期新患者的數量會以類似的速度成長？您能否詳細說明一下您如何看待未來成長速度？謝謝。

Yeah, it was a great quarter. We're really excited about it and as we said, we've continued that momentum into Q2. As we look towards the potential approval of SEMA, as we pointed out on one of the slides here, we have a couple of different views of how the market's going to evolve.

是的，這是一個很棒的季度。我們對此感到非常興奮，正如我們所說，我們在第二季度延續了這種勢頭。正如我們在一張投影片中指出的那樣，當我們展望 SEMA 的潛在批准時，我們對市場將如何發展有幾種不同的看法。

Clearly, they're talking about a market which is multiples the size of our 315,000 patients. Our efforts to date have really been focused on the 315,000. So there's plenty of patients when you consider where they're at about 5% penetration today. So we see, really years of growth in this market ahead. SEMA is only going to accelerate diagnosis and add to that 315,000.

顯然，他們談論的市場規模是我們 315,000 名患者的數倍。迄今為止，我們的努力主要集中在這 315,000 人身上。因此，如果考慮到目前滲透率約為 5%，那麼患者數量就很多了。因此，我們預見到未來幾年這個市場仍將持續成長。SEMA 只會加速診斷並將其添加到 315,000。

As I said, our efforts are on the 315,000. We believe there's a great market there. There's even a greater market if what they do happens which makes, as I said, multiples of the 315,000. So long way of saying, we feel really comfortable with our profile. We believe ours is the winning profile and we believe that we can grow through their potential approval and launch.

正如我所說，我們的努力集中在 315,000 人身上。我們相信那裡有巨大的市場。如果他們所做的事情能夠實現，那麼市場規模將會更大，正如我所說，這將是 315,000 的數倍。說了這麼多，我們對自己的形象感到非常滿意。我們相信我們的產品是成功的，我們相信我們能夠透過他們的潛在批准和推出而實現成長。

Yeah, and maybe Ellie I'll jump in here and just add a little bit, as Bill said, we expect this momentum of growth to continue into Q2. So we do expect, good quarter-over-quarter growth and also the same for 2025, robust growth for 2025, and I would just, give the commentary here for both the quarter and for the year we expect consensus to narrow and move up a little bit.

是的，也許艾莉，我會在這裡補充一點，正如比爾所說，我們預計這種成長勢頭將持續到第二季​​。因此，我們確實預計本季度將出現良好的環比增長，並且 2025 年也將實現強勁增長，我只想在此對本季度和全年做出評論，我們預計共識將會縮小並略有上升。

Andrea Newkirk, Goldman Sachs.

高盛的安德里亞紐柯克 (Andrea Newkirk)。

Hi everyone, good morning and congratulations on the quarter. Bill, could you just talk us through your expectations around payer reauthorization requirements that you might be seeing right now and how are you thinking about the persistency of these patients to continue on Rezdiffra beyond this first year? Thanks so much.

大家好，早安，恭喜本季。比爾，您能否向我們介紹一下您對目前可能看到的付款人重新授權要求的期望，以及您如何看待這些患者在第一年之後繼續使用 Rezdiffra 的堅持？非常感謝。

Thanks, Andrea. So you know reauthorizations are part of the process for every medicine, so we're not really concerned about that. Most of the policies, as we said in the past, require a 12 month re-off, and that's in line with most drugs.

謝謝，安德里亞。所以你知道重新授權是每種藥物流程的一部分，所以我們並不真正擔心這一點。正如我們過去所說，大多數政策都要求停藥 12 個月，這與大多數藥物一致。

Typically, it ends up being at kind of provider discretion or requires stabilization or some kind of measure on one of the NITs, so we don't see that as an issue specifically because we're hearing such great results from physicians and patients that have been on the drug.

通常，最終還是由提供者自行決定，或者需要對其中一種 NIT 進行穩定或採取某種措施，因此我們並不認為這是一個問題，因為我們從服用該藥物的醫生和患者那裡聽說了非常好的結果。

In fact, I said a lot of products when they launch, they typically don't live up to the well-controlled clinical trial environment that may show a certain level of efficacy. They end up declining a little bit. We're seeing absolutely the opposite in our case.

事實上，我說很多產品在推出時，通常都無法達到可能顯示出一定療效的良好控制的臨床試驗環境。它們最終會稍微衰退。在我們的案例中，我們看到的情況卻截然相反。

We have physicians and patients coming back and saying we're really seeing efficacy across a bunch of parameters and exceeding expectations in that sense, which leads to the persistency piece, which is because it's a well-tolerated oral, we would expect persistency to be, very good like other well-tolerated orals. So you know we feel we're in a really great spot because of the profile of the product and what the one year results are of seeing such strong real world experience.

醫生和患者回饋說，我們確實看到了一系列參數的療效，並且超出了預期，這導致了持久性問題，因為它是一種耐受性良好的口服藥物，我們預計持久性會像其他耐受性良好的口服藥物一樣非常好。所以你知道，我們覺得我們處於一個非常好的位置，因為產品的概況以及一年來看到如此強大的現實世界經驗的結果。

Ritu Baral, TD Cowen.

Ritu Baral，TD Cowen。

Good morning, guys. Thanks for taking the question and congratulations on this quarter. My question has to do with Europe. I believe you guys are well on your way for the CHMP documents as they post, but can I ask where you are on responding to their questions? I believe you requested an extension of the clock stop.

大家早安。感謝您提出這個問題，並祝賀本季取得的成績。我的問題與歐洲有關。我相信你們在 CHMP 檔案發佈時已經取得了很大進展，但我可以問一下你們是如何回答他們的問題的嗎？我相信您已要求延長時鐘停止時間。

What's the I guess the driver for the extra time needed to respond and as you go through these discussions for the Rezdiffra label, can you talk to how maybe Europe is approaching non-invasive testing different than FDA? It looks like they may be on accelerated acceptance, and does this factor into what label Rezdiffra may get in Europe? Thanks.

我猜想需要額外時間回應的原因是什麼？當您討論 Rezdiffra 標籤時，您能否談談歐洲在非侵入性測試方面的做法與 FDA 有何不同？看起來他們可能正在加速接受，這是否會影響 Rezdiffra 在歐洲獲得什麼標籤？謝謝。

Okay, Ritu, that's a lot there. I'm going to try to remember it all. Look, the questions we're getting, I think, are, all expected. We're still on track for our mid-year action we would expect, this is, you have to remember, just like with the FDA, this is the first MASH product ever approved in Europe.

好的，Ritu，就這麼多。我會盡力記住這一切。瞧，我認為我們所收到的問題都是意料之中的事。我們仍在按計劃執行我們預期的年中行動，這是，你必須記住，就像 FDA 一樣，這是歐洲有史以來批准的第一個 MASH 產品。

And I think agencies want to take their time and make sure that they understand and that they are putting forth kind of the best label that they can that is going to be really the foundation for all other MASH labels. So you know we're really happy with how the review is going and as I said, we're expecting approval and we'll expect to launch later this year.

我認為各機構需要花時間確保他們理解這一點，並盡可能地提出最好的標籤，這將成為所有其他 MASH 標籤的基礎。所以你知道我們對審查的進展感到非常滿意，正如我所說，我們期待獲得批准，並預計在今年晚些時候推出。

The question on NITs, yeah, look, so it's interesting, Europe's had a year plus to digest the fact that there's going to be a mash product, as we talked about last year, physicians in the US until the product was approved almost didn't believe there was going to be a product approved because of, the over 2 dozen or almost 2 dozen failures before us.

關於 NIT 的問題，是的，看，這很有趣，歐洲有一年多的時間來消化即將出現一種混合物產品的事實，正如我們去年談到的，美國的醫生在該產品獲得批准之前幾乎不相信會有這種產品獲得批准，因為在我們之前已經有超過 20 或近 20 例失敗了。

Europe, on the other hand, with the approval in the US has much more certainty, so the actions they've taken, starting with the EASL guidelines last year, are actually quite far ahead of the US. Now from an NIT perspective, we believe that there are there's enough installed NITs that will allow us to launch effectively, but just like the US, there's going to have to be additional NITs added as you have a new product that is approved and you actually have to start thinking about now how are you going to die. And stage patients a little bit differently.

另一方面，歐洲由於獲得了美國的批准，因此具有更大的確定性，因此他們從去年的 EASL 指南開始採取的行動實際上已經遠遠領先美國。現在從 NIT 的角度來看，我們相信已經安裝了足夠的 NIT，可以讓我們有效地啟動，但就像美國一樣，當你有一個獲得批准的新產品時，就必須添加額外的 NIT，你實際上必須開始思考你將如何消亡。且患者的分期也略有不同。

So in many ways the EU is ahead of the US from an action perspective, and we think that's probably more important than anything right now.

因此，從行動角度來看，歐盟在許多方面都領先美國，我們認為這可能比現在任何事情都更重要。

So we have EASL next week. We're really excited to talk directly to a lot of the physicians and hear firsthand from them how their prep is going, but I was impressed last year as well, so I'm sure they're that much further ahead, and that's certainly what our teams are telling us now.

下週我們將舉辦 EASL。我們非常高興能夠直接與許多醫生交談，並直接聽取他們的準備工作進展情況，但去年我也印象深刻，所以我相信他們已經走得更遠了，這當然也是我們的團隊現在告訴我們的。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

Hey, thanks so much. Can you talk about your relative confidence in showing an OUTCOMES benefit on hepatic events in F2, F3, versus F4? We're digging this internally and there's some clear encouraging signals, whether it's the INTERCEPT trial or even SEMA in F2/F3. There's almost no correlation we're seeing in F4 between liver fat reduction and actual hepatic events. So what gives your team confidence the liver stiffness data will actually translate? I really appreciate it.

嘿，非常感謝。您能否談談您對 F2、F3 與 F4 中肝臟事件結果益處的相對信心？我們正在內部挖掘這個問題，並且發現了一些明顯的令人鼓舞的信號，無論是 INTERCEPT 試驗還是 F2/F3 中的 SEMA。在 F4 中，我們幾乎沒有看到肝臟脂肪減少和實際肝臟事件之間的關聯。那麼，是什麼讓您的團隊相信肝臟硬度數據能夠真正轉換呢？我真的很感激。

Thanks for the question. Nice to hear from you. Look, I think that as we showed in the slides today, this 6.7 kPa reduction in two years, we think is actually quite meaningful. I think the literature supports that. But if we take even a step back further.

謝謝你的提問。很高興收到你的來信。看，我認為，正如我們今天的幻燈片中所展示的，兩年內減少 6.7 千帕，我們認為這實際上是非常有意義的。我認為文獻支持這一點。但如果我們再退一步來看。

Mechanistically, our MOA a liver directed therapy. It's really looked at as kind of the master regulator of fibrosis, and we believe that starting from that point we have great confidence in the mechanism. Now the data to date with the reduction in liver stiffness in this cohort of patients, and we're going to explain more about it next week, I would encourage you to listen in.

從機制上講，我們的 MOA 是一種針對肝臟的治療。它確實被視為纖維化的主要調節器，我們相信，從那時起，我們對機制非常有信心。目前為止的數據顯示這群患者的肝臟硬度降低，我們將在下週對此進行更多解釋，我鼓勵您收聽。

It gives us further confidence that that is getting at the heart of the problem and therefore we won't have the events that you would without treatment. So I think you know everything from the biology to what we've seen early gives us great confidence in our F4c trial that's ongoing there.

這讓我們更加相信，這正是問題的核心，因此，如果不進行治療，我們就不會發生這樣的事件。所以我認為，從生物學到我們早期所看到的一切都讓我們對正在進行的 F4c 試驗充滿信心。

You know, we have 845 patients. It's a well-sized trial and we're more encouraged, as I said, by the data that we've talked about today and we're going to talk about at EASL next week. So yeah, look, like anything else, that's why you do the trials, right? And we'll have to see what results ultimately look like, but so far we remain, extremely confident in the outcome.

你知道，我們有 845 位患者。這是一個規模適中的試驗，正如我所說，我們今天討論的數據以及下週在歐洲肝病學會年會上討論的數據讓我們更加鼓舞。是的，看起來，就像其他事情一樣，這就是你進行試驗的原因，對嗎？我們必須看看最終結果如何，但到目前為止，我們仍然對結果非常有信心。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米、派珀·桑德勒。

Good morning team. Congrats on a great quarter. My question is just now that you've had patients for over a year on therapy, have you been able to quantify sort of what the compliance rate is and sort of as patients are, kind of talking like, do they feel function better as they're on the drug? So what is the adherence rate that you're seeing and how do you think it will be projected moving forward? And I'll jump back in the queue.

大家早安。恭喜本季取得優異成績。我剛才的問題是，您已經讓患者接受治療一年多了，您是否能夠量化患者的依從率，以及患者是否感覺服用藥物後身體機能更好？那麼您看到的依從率是多少？您認為未來的依從率將如何發展？我將重新回到隊列中。

Yeah, thanks for the question. It's a little early to be making a call on ultimately what does adherence look like. However, all the early signs are very promising, and I think again it goes back to the well-tolerated nature of the product and the overall profile of the product.

是的，謝謝你的提問。現在就最終判斷依從性是什麼樣的還為時過早。然而，所有早期跡像都非常有希望，我認為這再次歸功於該產品良好的耐受性和產品的整體概況。

One of the questions that I think people were asking was this is an asymptomatic disease, is why would someone stay on? Well, the physicians have been able to give really positive feedback to patients because they're seeing these results across a number of parameters, and that always gives people a reason to stay on, especially if they're not feeling any really significant tolerability issues along the way.

我認為人們問的一個問題是，這是一種無症狀疾病，為什麼有人會繼續留在醫院？嗯，醫生已經能夠向患者提供非常積極的回饋，因為他們在多個參數上都看到了這些結果，而這總是給人們一個繼續治療的理由，特別是如果他們在過程中沒有感覺到任何真正嚴重的耐受性問題。

We've had talked to a lot of patients and anecdotally we hear, some patients that are saying as well that, they feel better, and I think it's a little bit of a hope. They're worried about the consequences of severe liver disease, right?

我們與許多患者交談過，我們聽到一些患者也說他們感覺好多了，我認為這是一點希望。他們擔心嚴重肝病的後果，對嗎？

They've seen some of them have family members that have gone through transplant. Some family members have died from MASH, and it's, I hadn't expected this as much, but the hope that they now have because there's a once a day pill, that's really kind of astonishing, and that's giving people as well, I think the reason to stay on. So we're really optimistic it's early, but all signs right now suggest that we will have an adherence rate very consistent with well-tolerated orals.

他們發現其中一些人的家人也經歷過移植手術。一些家庭成員因 MASH 而死亡，我並沒有想到會有這麼多，但是由於每天只需服用一次，他們現在有了希望，這真的有點令人驚訝，我認為這也給了人們堅持下去的理由。因此，我們非常樂觀，現在還為時過早，但現在所有跡像都表明，我們的依從率將與耐受性良好的口服藥物非常一致。

Liisa Bayko, Evercore.

Liisa Bayko，Evercore。

Hi, thanks for taking the question and congratulations on a strong quarter. I just want to drill a little bit more into, two topics. One is if you get any more granular and grows to net for the quarter, and then, the project, the trajectory from here, I know you said it was it would be kind of, a little bit, up and down, but just curious, on more specifics.

您好，感謝您回答這個問題，並祝賀您本季業績表現強勁。我只是想更深入地探討兩個主題。一是如果你能獲得更詳細的資訊並增長到本季度的淨額，那麼，這個項目，從這裡開始的軌跡，我知道你說過它會有點，有點，起伏，但我只是好奇，更具體一點。

And then on in terms of like GLP-1s and this whole concept, I guess today. What is your estimate of what percentage of your patients are on GLP-1s? How do you expect this to change as semaglutide gains label expansion into MASH, and do you expect any kind of step through or any payers to kind of lean that way as that comes on board later on this year?

然後就 GLP-1 和整個概念而言，我想今天。您估計有多少比例的患者正在服用 GLP-1？隨著司美格魯肽在 MASH 中的標籤擴展，您認為這種情況將如何變化？您是否預計在今年稍後推出任何形式的步驟或任何付款人都會傾向於這種方式？

Thanks, Lisa. It's a couple of questions, but those are ones that I'm sure are on people's minds, so maybe we'll go with that. Maybe starting with the GLP-1 combo. So as we reported previously, 25% of patients are on a GLP-1 that are on Rezdiffra.

謝謝，麗莎。這是幾個問題，但我確信這些問題都是人們所關心的，所以也許我們會討論這些問題。也許從 GLP-1 組合開始。正如我們之前報導的那樣，25% 的患者正在服用 GLP-1 藥物，同時也服用 Rezdiffra 藥物。

That's our estimate right now, and it jumps to about 50% that have been exposed previously. So GLP-1s, we have to remember they're not new. They've been here for over a decade. Despite them being here for over a decade, there's still this MASH challenge that exists. People are still diagnosing and seeing MASH and patients are progressing.

這是我們目前的估計，之前曝光的數字已經躍升至 50% 左右。所以我們必須記住，GLP-1 並不是新產品。他們已經在這裡住了十多年。儘管他們在這裡已經十多年了，但 MASH 挑戰仍然存在。人們仍在診斷和觀察 MASH，患者的病情正在好轉。

So GLP-1s and the question of is there a step through, look, it's early, they haven't been approved yet. We have to see what the label looks like and ultimately what their approval looks like. However, we've planned for all scenarios and as I said on a question earlier, we feel very confident that we can grow through all scenarios.

因此，GLP-1 和是否有突破性的進展的問題，看，現在還為時過早，它們尚未獲得批准。我們必須看看標籤是什麼樣子的，以及最終他們的批准是什麼樣子的。然而，我們已經為所有情況做好了計劃，正如我之前回答問題時所說，我們非常有信心能夠在所有情況下實現增長。

So part of that has to do with the fact that, A, 5his is a high unmet need. B, we've got a great profile. We're a liver directed once a day pill. You've heard me call it the holy grail of profiles. Profiles matter at the end of the day.

所以部分原因在於，A，這是一個很大的未滿足需求。B，我們有一個很棒的形象。我們是一種針對肝臟的每日一次的藥丸。您曾聽我說過，它被稱為個人資料的聖杯。歸根結底，個人資料很重要。

You've got to take a drug for it to work. It's controlled, well-controlled studies are great, but in the real world you've got to take a drug for it to work, and we feel like we're in a really good place. Now from a gross to net perspective, we've been extremely diligent about gross to net. You've heard me say from the beginning. We have planned for years ahead, not a single quarter, but we've really looked towards the evolving landscape.

你必須服用藥物才能使其起作用。它是受控的，控制良好的研究很棒，但在現實世界中，你必須服用藥物才能起作用，我們覺得我們處於一個非常好的位置。現在從總額到淨額的角度來看，我們對總額到淨額一直非常勤勉。您從一開始就聽我說過。我們已經為未來幾年制定了計劃，而不是僅僅一個季度，但我們確實在關注不斷變化的情況。

We're looking at different products coming into the market thinking about new indications for us. And as you know, we started in a really great position. We really preserved gross to net out of the gate by not contracting, largely because of the innovative nature of the product, right?

我們正在研究進入市場的不同產品，思考它們對我們有何新的適應症。正如你們所知，我們的起步位置非常好。我們確實透過不簽訂合約保持了毛利和淨利的平衡，這主要是因為產品的創新性，對嗎？

You know this has been the graveyard of drug development and Rezdiffra really broke through and we take that into consideration. However, you can't escape the dynamics of the market. Payers are always evaluating the landscape evolves, whether it's a new calendar year or you get a competitive entrant. So we've thought about gross to net anticipating that there will be additional competition, etc.

您知道，這是藥物開發的墳墓，而 Rezdiffra 確實取得了突破，我們會考慮到這一點。然而，你無法逃避市場的動態。付款人總是在評估情況的發展，無論是新的一年還是有競爭者進入。因此，我們考慮了總額與淨額的關係，預計會有更多競爭等等。

And we've had good partnerships with payers. We're going to keep those good partnerships, but in line with that, we started contracting in Q2. And it's not everywhere and it's not all at once. It's an evolution. It's going to take time.

我們與付款人建立了良好的合作關係。我們將保持這些良好的合作夥伴關係，但同時，我們在第二季開始簽訂合約。它並不是無所不在，也不是一下子發生的。這是一種進化。這需要時間。

So we are right where we thought we would be. We're executing kind of our plan for the short, medium, and long term, and feel we're in a really strong position. But maybe Mardi, perhaps you could comment a little bit more on the [GLP] dynamic in '25.

所以我們正處於想像的位置。我們正在執行短期、中期和長期計劃，並且感覺我們處於非常有利的地位。但也許 Mardi，你可以對 25 年的 [GLP] 動態再多發表一點評論。

I'm happy to. As Bill said, we've been very disciplined with our growth to net, but it is absolutely part of our business going forward.

我很樂意。正如比爾所說，我們對淨成長一直非常嚴格，但這絕對是我們未來業務的一部分。

We've also said it continues to be choppy and that's going to be the case as we continue to launch, but our team did a fantastic job from fourth quarter into first quarter and managed the dynamics really well. I would say specifically for Q1, we are a little favorable across the board for (inaudible), but we're really staying within the range that's typical for specialty pharmacy products.

我們也說過，情況會繼續不穩定，而且隨著我們繼續推出產品，情況也會如此，但我們的團隊從第四季度到第一季做得非常出色，很好地控制了情況。我想說的是，具體到第一季度，我們對（聽不清楚）總體上有點看好，但我們確實保持在專業藥品的典型範圍內。

And we do see, as we said last quarter, that this will continue to step up throughout the year in 2025, particularly with some of the contracting as Bill said, not everywhere, not all at once, but as that continues to take effect throughout the year. So anyway, we're in really great shape with our gross in that and right as part of our expectations moving forward.

正如我們上個季度所說的那樣，我們確實看到，到 2025 年，這種趨勢將繼續加強，特別是像比爾所說的那樣，一些合約不會在所有地方發生，也不會同時發生，但會持續到全年。無論如何，我們的總收入狀況非常好，這也符合我們未來的預期。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Oh hey, congrats on the impressive launch progress and thanks to Becky for her pioneering efforts successfully bringing Rezdiffra to market.

哦，嘿，祝賀令人印象深刻的發布進展，並感謝 Becky 的開創性努力，成功地將 Rezdiffra 推向市場。

Can you talk about any feedback on the key messages in your DTC campaign and how that's impacted the launch trajectory? And then with regards to business development, as you look ahead to extending your leadership position in MASH, what sort of complementary assets would you like to add to Rezdiffra?

您能否談談對 DTC 活動中的關鍵訊息的回饋以及這些資訊對發布軌蹟的影響？然後關於業務發展，當您展望擴大您在 MASH 的領導地位時，您希望為 Rezdiffra 添加哪些互補資產？

Great, Jay, thanks for the question. First of all, on DTC, yeah, feedback is very positive about our DTC. The idea is to get to mostly diagnose patients and have them prepared to take action when they go to see their provider.

太好了，傑伊，謝謝你的提問。首先，關於 DTC，是的，對我們的 DTC 的回饋非常積極。這樣做的目的是主要對患者進行診斷，並讓他們做好在就診時採取行動的準備。

Feedback from the whole community has actually been very strong, and we're really encouraged by it, and we think it's an important piece of the mix because this is a disease that people don't know a lot about. We still know that the biggest issue is taking action, and we hear every day of tragic stories of patients where physicians haven't taken action or where patients didn't know what fatty liver disease meant and came back years later to find out if they need a transplant. That is something that we as a company, our purpose is really to fight against MASH.

來自整個社區的回饋實際上非常強烈，我們對此感到非常鼓舞，我們認為這是一個重要組成部分，因為人們對這種疾病了解不多。我們仍然知道最大的問題是採取行動，我們每天都會聽到一些悲慘的故事，有些病人的醫生沒有採取行動，或者病人不知道脂肪肝意味著什麼，幾年後才回來詢問是否需要移植。作為一家公司，我們的真正目的是對抗 MASH。

We take it seriously. Education through DTC is important. As our DTC continues to evolve, I would direct you to a new campaign that we have at [diffusemash.com]. This really gets to the heart of this is a serious disease and action is required. That's once again diffusemash.com.

我們非常重視此事。透過 DTC 進行教育非常重要。隨著我們的 DTC 不斷發展，我想向您介紹我們在[diffusemash.com]。這確實觸及了一種嚴重疾病的本質，需要採取行動。這又是 diffusemash.com。

I feel like I know that it sounds like I'm doing a commercial myself right there. That wasn't the intent, but I wanted to make sure that Jay you got the website to go to. Your second question was on business development. I look, we've been really clear all along.

我感覺我知道這聽起來就像我自己在做廣告。這不是我的本意，但我想確保 Jay 你能訪問這個網站。您的第二個問題是關於業務發展。我看，我們一直以來都很清楚。

We are in this really enviable position. Most position, most companies have a pipeline looking for a great asset. We have a great asset and now we have the luxury of building a pipeline to sustain our leadership position. You don't get many opportunities like this in the industry where you're the first to launch in a very significant disease that has had a checkered past in development because it's been such a difficult disease to attack.

我們正處於一個令人羨慕的地位。大多數職位、大多數公司都有尋找優秀資產的管道。我們擁有龐大的資產，現在我們有能力建立一條管道來維持我們的領導地位。在這個行業中，你不會得到很多這樣的機會，你是第一個將藥物投入到治療一種非常嚴重的疾病的，這種疾病在發展過程中經歷了一段坎坷，因為它是一種很難治療的疾病。

We're first, we've done it, and it's really with a product that is very specific to the problem. It's liver directed. And is a great profile, but in order for us to extend our leadership, we think it is important to have additional products available.

我們是第一個做到這一點的人，而且我們確實開發了一款針對特定問題的產品。這是針對肝臟的。這是一個很棒的形象，但為了擴大我們的領導地位，我們認為提供更多產品非常重要。

The focus will be in MASH, and we're looking at next mechanisms of action that are compelling or products that could be combined with Rezdiffra to make Rezdiffra and the new entity that much better. So that allows us to either extend efficacy work in new different pardon me, segments of the population, etc.

重點將放在 MASH 上，我們正​​在研究下一步引人注目的行動機製或可以與 Rezdiffra 結合的產品，以使 Rezdiffra 和新實體變得更好。這樣，我們就可以在新的不同人群、不同群體等中擴展功效工作。

So we're looking across the entire pipeline early stage to late stage. We're going to base it on mechanisms that we're interested in, mechanisms that we think could be helpful for patients, and we will then be very diligent in the way that we actually go about doing our deals, we're not going to do a bet the company strategy on any of this.

因此，我們正在關注從早期階段到後期階段的整個流程。我們將以我們感興趣的機制、我們認為可能對病人有幫助的機制為基礎，然後我們將非常勤勉地進行我們的交易，我們不會將公司策略押注於這些方面。

We don't have to. So we'll maintain that financial discipline. We'll do good deals. We'll do deals that are going to make a difference ultimately for patients and sustain our leadership in the future. So more to come on that when we have something to present.

我們沒必要這麼做。因此，我們將保持財務紀律。我們會達成很好的交易。我們將達成最終能為患者帶來好處的交易，並在未來保持我們的領先地位。當我們有東西要展示時，我們會提供更多資訊。

[Mayank Mamtani, B. Riley Securities].

[Mayank Mamtani，B. Riley 證券]。

Thanks for taking our questions and congrats on strong quarter. Digging into the Novo's New England publication from last night on a sense, it seems that the SEMA benefit is coming in interestingly low to mid BMI F2 patients rather than F3 more advanced. It would be great to hear though your thoughts on how maybe you're thinking about patient segmentation.

感謝您回答我們的問題，並祝賀本季業績強勁。從某種意義上來說，深入研究昨晚 Novo 的新英格蘭出版物，似乎 SEMA 的好處在於 BMI 較低的到中等的 F2 患者，而不是更高級的 F3 患者。我很高興聽到您對患者細分的看法。

Obviously, your benefit seems more pronounced in the more advanced [FCF4] and just quickly on going back to the comments on EU approval launch strategy mid-year. Curious the implications of this F4 data coming in at EASL, but also on pricing given macro discussions on, innovation being possibly better rewarded in in EU countries. Thanks again for taking our questions.

顯然，您的利益在更先進的 [FCF4] 中似乎更為明顯，並且很快就回到對年中歐盟批准啟動戰略的評論。我很好奇 EASL 發布的 F4 數據有何影響，以及鑑於宏觀討論的定價問題，歐盟國家的創新可能會獲得更好的回報。再次感謝您回答我們的問題。

Right, okay, thank you very much for the question. Look, we didn't see anything new actually. We just, we got it last night like everyone else, so we're looking through it, but really nothing new there, well-controlled trial, you get results from a well-controlled trial.

好的，好的，非常感謝您的提問。看，我們實際上沒有看到任何新東西。我們就像其他人一樣，昨晚就得到了它，所以我們正在仔細研究它，但實際上沒有什麼新東西，控制良好的試驗，你會從控制良好的試驗中獲得結果。

I think that the real question is what's the applicability to the real world and I think, we know that in the real world, GLP-1a, there's a challenge specifically of, keeping people on drugs and getting them to the highest dose.

我認為真正的問題是其對現實世界的適用性，而且我認為，我們知道在現實世界中，GLP-1a 面臨的具體挑戰是讓人們繼續服藥並讓他們服用最高劑量。

So you know nothing's changed from our perspective looking at looking at that news now you know where right now where we're used, it's about 50/50 F2/F3 patients and you know what happens is physicians, pardon me, a patient comes into their into the see the physician.

因此，您知道，從我們的角度來看，什麼都沒有改變，看看現在的新聞，您知道我們現在使用的情況，大約是 50/50 的 F2/F3 患者，您知道會發生什麼，醫生，對不起，一個病人來到他們那裡看醫生。

Every, 6 months, 12 months, and the physicians looking at that patient at that moment, and if they have F2, they say, well, let's wait a year, they could go to F3, they could, who knows where they're going to go. They're making that decision at the moment and that's why we're seeing that they're often choosing to treat.

每 6 個月、12 個月，醫生都會觀察當時的病人，如果病人處於 F2 階段，他們會說，好吧，讓我們等一年，他們可能會進入 F3 階段，誰知道他們會進入哪個階段。他們現在正在做出這個決定，這就是為什麼我們看到他們經常選擇治療。

Whether it be F2 or F3, so we expect that that mix to continue, as we have hopes to move into F4c as well, and we think that, we will be the product F2 to F4c period, which is, I think, an ambitious but ultimately realistic goal.

無論是 F2 還是 F3，我們都希望這種組合能夠繼續下去，因為我們也希望進入 F4c，並且我們認為，我們將成為 F2 到 F4c 時期的產品，我認為這是一個雄心勃勃但最終現實的目標。

So feel really comfortable with our with our positioning and our profile. Regarding Europe and thinking about pricing and so forth, I mean, look, we're going through our pricing analysis now. Our belief is we have a very innovative product and that the innovation will be recognized in Europe. I think that the dynamics of GL1-s look, as we said. And a lot of patients are already have already been exposed to a GLP1 and still have MASH.

所以，請對我們的定位和形象感到非常滿意。關於歐洲以及定價等問題的思考，我的意思是，看，我們現在正在進行定價分析。我們相信，我們擁有一款非常創新的產品，而且這項創新將在歐洲得到認可。我認為 GL1-s 的動態看起來就像我們所說的那樣。很多患者已經接觸過 GLP1 但仍患有 MASH。

That's, 50% of our patients have already been exposed, but they still have this problem. So, we think that the two can co-exist, we are only going to be focusing on those patients that we think are most in need, those that need a liver directed therapy, and we think that there's, plenty of room for us in GLP-1s.

也就是說，我們的病人有50%已經接觸過病毒，但仍然有這個問題。因此，我們認為兩者可以共存，我們只會關注那些我們認為最需要的患者，那些需要肝臟導向治療的患者，我們認為 GLP-1 有足夠的空間。

We're at the very beginning of a market. You know what my experience is that every time you have a new entrant enter a market, the market growth increases pretty significantly, and clearly that's a stated goal by Novo. So there's going to be lots of patients that are going to be available for us regardless of how the dynamics evolve.

我們正處於市場起步階段。您知道我的經驗是，每當有新進業者進入市場時，市場成長就會顯著增加，顯然這是 Novo 的既定目標。因此，無論情況如何發展，我們都會接收大量患者。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Hi, thank you so much for bringing my questions and congratulations on the strong quarter. So, I had a couple, follow up on growth to net as well, but maybe longer term for 2026 and beyond as you are having the initial payer contracting discussions for next year. What do you expect in terms of the net pricing evolution for 2026?

你好，非常感謝您提出我的問題，並祝賀本季業績強勁。因此，我有幾個問題，也跟進了淨增長，但也許是 2026 年及以後的長期問題，因為您正在就明年進行初始付款人合約討論。您對 2026 年淨價的演變有何預期？

Do you expect a big step up compared to 2025 given the summer launch and just curious as to what you're hearing from the payers, especially given the pricing differential. And secondly, maybe quickly on BD clearly seems to be a priority, but what exactly is the BD capacity given the ongoing investments in the launch in the US and later Europe? Thank you so much.

鑑於夏季推出，您是否預計與 2025 年相比會有大幅提升？我只是好奇您從付款人那裡聽到了什麼，特別是考慮到定價差異。其次，也許快速推出 BD 顯然是當務之急，但考慮到在美國和隨後的歐洲推出的持續投資，BD 的產能究竟如何？太感謝了。

All right, thanks for the question. Maybe I'll start with just a comment on gross net, and then Mardi can provide a little bit more. I mean, look, as I said, you heard me answer earlier, we've taken a long term view of gross net. We know with, pretty good certainty what the potential market evolution looks like with new entrants just looking at the pipeline and so forth. It's a little early to comment on '26.

好的，謝謝你的提問。也許我會先對總淨值發表評論，然後 Mardi 可以提供更多資訊。我的意思是，你看，正如我所說的，你之前聽到我回答，我們對總淨值採取了長期看法。我們非常確定，當新進業者只關注通路等時，潛在的市場發展會是什麼樣的。現在評論 26 還為時過早。

Gross to net only goes in one direction. And we've been very disciplined about it. We'll continue to be, we have a very significant value proposition with the product that we have, so we think that we'll continue to be in a very favorable place from a gross from that perspective. But maybe, Marty, do you want to comment any more on that, or it's still early? Yeah.

總分到淨分只朝一個方向。我們對此一直非常嚴謹。我們將繼續對我們的產品提出非常重要的價值主張，因此我們認為從這個角度來看，我們將繼續處於非常有利的地位。但是，馬蒂，也許你想對此發表更多評論，或者現在還為時過早？是的。

It's really too early Prakhar, so on 2026, but it's all part of our business, it's all part of our expectations. We have ongoing dialogue and good relationships with the payers, and we'll talk about that more as the year progresses.

普拉卡爾，現在說 2026 年還為時過早，但這都是我們業務的一部分，也是我們期望的一部分。我們與付款人保持著持續的對話和良好的關係，隨著時間的推移，我們將更多地談論這一點。

Yeah. And then regarding BD, as I said, we're not doing a bet the company strategy. We're going to be very diligent and disciplined about the way we do deals. And Mardi, do you want to comment? Yeah.

是的。關於 BD，正如我所說，我們不會拿公司策略做賭注。我們將非常勤勉嚴謹地處理交易。Mardi，你想發表評論嗎？是的。

Yeah, you talked about the capacity, and I think Bill's point is right. We're not vetting the company here. We're in a great position from a cash standpoint, and that cash is we're focused on building, out the US launch and the ex US launch. If we do BD that may put a different lens on our cash flow, but right now we're in a very good position with our cash.

是的，你談到了容量，我認為比爾的觀點是正確的。我們不會在這裡審查該公司。從現金角度來看，我們處於有利地位，而且我們專注於利用這些現金在美國和美國以外地區開展業務。如果我們進行 BD，可能會對我們的現金流量產生不同的看法，但目前我們的現金狀況非常好。

Andy Chen, Wolfe Research.

安迪‧陳 (Andy Chen)，沃爾夫研究公司 (Wolfe Research)。

Hi, this is Emma on for Andy. Thanks for taking our question and congrats on the quarter. You mentioned six abstracts will be presented at EASL next week. I guess just aside from the late breaker, which is more focused on, the F4c data, what are other key findings to look out for F4? Thank you.

大家好，我是 Emma，為 Andy 服務。感謝您回答我們的問題，並祝賀本季取得的成績。您提到下週將在 EASL 上展示六篇摘要。我想，除了更關注的後期報告和 F4c 數據之外，還有哪些關鍵發現值得關注 F4？謝謝。

Well, look, that's going to be the big data that we're going to be presenting there. We think it's really important, especially, we've seen that there's been this kind of gravitation and interest in FGF21 in F4c. We have data which we think is just really impressive, and you're going to see that in the late breaker. We have, as you said, we have six different posters, etc. there.

好吧，看，這就是我們要在那裡展示的大數據。我們認為這非常重要，尤其是我們已經看到人們對 F4c 中的 FGF21 產生了這種關注和興趣。我們擁有的數據確實令人印象深刻，您將在最新消息中看到這一點。正如您所說，我們在那裡有六張不同的海報等等。

It covers really a large gamut, everything from some of the unmet need to more specific results that we're seeing in Germany, for instance, from claims analysis that we've done, etc. So it's a little bit of an evolution of the data that we have and some more details about the severity of the disease and what you're seeing in the real world from, incidents of things like HCC, etc.

它涵蓋的範圍非常廣泛，從一些未滿足的需求到我們在德國看到的更具體的結果，例如，從我們所做的索賠分析等。因此，它是我們擁有的數據的一點演變，以及有關疾病嚴重程度的更多細節，以及您在現實世界中看到的HCC等事件的情況。

So it's a pretty exciting meeting for us, the presentations we're going to be doing are great. I'd say probably more than anything we're looking forward to just the interaction with the community there and what we're hearing is there's a lot of anticipation about the dialogue that we're going to be having with. Various physicians from literally around the world that attend. So it's a great meeting for us.

所以對我們來說這是一次非常令人興奮的會議，我們將要做的演示非常精彩。我想說，我們最期待的可能是與那裡的社區互動，我們聽到的是，人們對我們將要進行的對話抱有很高的期待。來自世界各地的各種醫生都來參加。所以這對我們來說是一次很棒的會議。

The big news is the late breaker and thus therefore it's a late breaker because it is of such interest. So stay tuned. Hope to see some of you over there and certainly hope that you will join us on our call looking at that F4c data after EASL.

大新聞都是晚點發布的，因此它之所以被稱為晚點發布，是因為它太受關注了。敬請關注。希望在那裡見到你們，當然也希望你們能加入我們的電話會議，查看 EASL 之後的 F4c 數據。

Great. Emma, thanks for that question. And Tawana, thanks for your time and thank you all for your interest today. This is now the time we're going to conclude the call. A replay of this webcast will be available on our website in approximately two hours. So thank you so much for joining us.

偉大的。艾瑪，謝謝你提問。Tawana，感謝您抽出時間，也感謝大家今天的關注。現在是我們結束通話的時間了。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。非常感謝您加入我們。

That concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。