Madrigal Pharmaceuticals Inc (MDGL) 2024 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Madrigal Pharmaceuticals second quarter 2024 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.

美好的一天，感謝您的支持。歡迎參加 Madrigal Pharmaceuticals 2024 年第二季財報電話會議。（操作員說明）提醒一下，今天的電話會議正在錄音。現在我想介紹一下首席投資者關係長蒂娜·文圖拉女士。請繼續。

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

謝謝你，[馬拉拉]。大家早安，感謝您加入我們討論 Madrigal 2024 年第二季收益。我們今天早上發布了一份新聞稿，並在本次網路廣播中附帶了幻燈片，該幻燈片將在電話會議後立即發佈在我們網站的投資者關係部分。今天與我通話的是執行長 Bill Sibold；和財務長 Mardi Dier，他們將提供準備好的評論，然後我們將回答您的問題。

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

我們的目標是將今天的通話時間控制在 45 分鐘左右。請注意，在投影片 2 上，我們今天將做出某些前瞻性聲明，我們建議您參閱我們向 SEC 提交的文件，以討論可能導致實際結果與前瞻性聲明不同的風險。

And with that, I will now turn the call over to Bill on slide 3.

現在，我將把電話轉給幻燈片 3 上的比爾。

Thanks, Tina. Good morning, and thanks for joining. I'll cover three topics on our call this morning. First, an update on the Rezdiffra launch, where we are off to a strong start this quarter. Our key metrics are also showing strength and are consistent with market research, reflecting high physician awareness and intent to prescribe.

謝謝，蒂娜。早安，感謝您的加入。我將在今天早上的電話會議上討論三個主題。首先，介紹一下 Rezdiffra 發布的最新情況，我們本季取得了良好的開局。我們的關鍵指標也顯示出實力，並且與市場研究一致，反映出醫生的高度意識和處方意願。

Second, our progress wiring the system where we are four months into what we expect to be about a 12 month process. This is our number one priority. As with other first-in disease launches, we are driving a change in clinical practice and physician behavior and developing processes for efficient patient and prescription flow.

其次，我們的系統連線進度目前預計為 12 個月，但現在已經過了 4 個月。這是我們的首要任務。與其他首次推出的疾病一樣，我們正在推動臨床實踐和醫生行為的改變，並開發高效的患者和處方流程流程。

Our goal is to establish a strong foundation to support peak sales. And third, our strategy to maximize the long-term value of Rezdiffra. In addition to the untapped opportunity in the US, we announced today that we plan to directly launch Rezdiffra in Europe following an EMA decision expected next year.

我們的目標是建立堅實的基礎來支持高峰銷售。第三，我們的策略是最大化 Rezdiffra 的長期價值。除了美國尚未開發的機會外，我們今天還宣布，繼 EMA 預計明年做出決定後，我們計劃直接在歐洲推出 Rezdiffra。

Let's start with the launch on slide 4. As discussed in our first quarter call, we are providing second quarter metrics on three key areas demand, including patient numbers, payer coverage and prescriber uptake. We generated $14.6 million in net sales in the second quarter and exited the quarter with more than 2000 patients on Rezdiffra

讓我們從幻燈片 4 上的啟動開始。正如我們在第一季電話會議中討論的那樣，我們將提供有關三個關鍵領域需求的第二季度指標，包括患者數量、付款人覆蓋率和處方者使用率。我們第二季的淨銷售額為 1,460 萬美元，本季結束時，Rezdiffra 患者數量超過 2,000 名

In addition to driving demand, we have put a lot of focus on the time it takes to fill a prescription. With the physician community, magical patient support, specialty pharmacies and payers. Our field team is focused on patient selection with prescribers. Our patient support team and the specialty pharmacies in our limited distribution network are driving efficient prescription processing and payers are executing on medical exceptions more efficiently because they recognize the unmet need.

除了推動需求之外，我們也非常關注配藥所需的時間。擁有醫生社區、神奇的患者支援、專業藥房和付款人。我們的現場團隊專注於與處方醫生一起選擇患者。我們的患者支援團隊和有限分銷網絡中的專業藥房正在推動高效的處方處理，付款人正在更有效地執行醫療例外，因為他們認識到未滿足的需求。

As a result, patients are moving more quickly through the reimbursement process. We have previously discussed our expectation for time to fill to improve from about 60 days at launch to about 30 days or less at six months because of our efforts time to fill was running faster in the second quarter compared to those initial expectations.

因此，患者可以更快完成報銷流程。我們之前已經討論過，我們對填補時間的預期從發佈時的約60 天縮短到六個月後的約30 天或更短，因為我們的努力與最初的預期相比，第二季度的填補時間運行得更快。

We're also very encouraged by the progress we've made with payers. They understand the significant unmet need in NASH, which is the number one driver of liver transplants for women in the United States. They also recognize the clinical benefits of Rezdiffra for F2/F3 patients and that noninvasive tests or NITs not biopsies, are standard of care.

我們與付款人的進展也讓我們深受鼓舞。他們了解 NASH 的巨大未滿足需求，NASH 是美國女性肝臟移植的第一大驅動因素。他們也認識到 Rezdiffra 對 F2/F3 患者的臨床益處，且非侵入性測試或 NIT（而非活檢）是護理標準。

Last quarter coverage was at 30% of commercial lives. As of June 30 more than 50% of commercial lives now have coverage in place for Rezdiffra with over 95% of Rezdiffra covered lives, accepting NITs and not requiring biopsies. We are well on our way to achieving our goal of 80% of commercial lives covered by year end.

上季的覆蓋率為商業生活的 30%。截至 6 月 30 日，超過 50% 的商業生活已覆蓋 Rezdiffra，超過 95% 的商業生活已接受 Rezdiffra 覆蓋，接受 NIT 且不需要活檢。我們正在順利實現年底前覆蓋 80% 商業生活的目標。

As far as government payers as of July 1, Medicaid coverage was in place across all 50 states. Similar to what we've seen with commercial coverage, virtually all except NITs and do not require biopsies. For Medicare, we are on track for full coverage beginning January 1 of next year based on the annual review process for new medications. Currently, Medicare patients are accessing Rezdiffra via the medical exception process with prior authorization requirements consistent with our label.

就政府付款人而言，截至 7 月 1 日，醫療補助涵蓋範圍已涵蓋所有 50 個州。與我們在商業報道中看到的類似，除了 NIT 之外，幾乎所有這些都不需要活檢。對於 Medicare，根據新藥物的年度審查流程，我們預計從明年 1 月 1 日開始實現全面覆蓋。目前，Medicare 患者正在透過醫療例外流程使用 Rezdiffra，且事先授權要求與我們的標籤一致。

We are pleased with the progress we have made with the 6,000 top hepatologists and gastroenterologists that we are targeting who are caring for the vast majority of the 315,000 diagnosed F2/F3 patients. In the second quarter, approximately 20% of our top targets wrote a Rezdiffra prescription, which is aligned with the penetration level often seen in launches of blockbuster medicine.

我們對 6,000 名頂尖肝病專家和胃腸病學家所取得的進展感到高興，他們正在照顧 315,000 名確診的 F2/F3 患者中的絕大多數。第二季度，大約 20% 的首要目標開了 Rezdiffra 處方，這與重磅藥物上市時常見的滲透程度一致。

As you'd expect early in launch, we've seen hepatologists adopting more quickly due to their expertise with the disease and NITs. Gastroenterology practices can take a bit longer given that NASH isn't their primary disease area and they need to think their practice dynamics for patients. Across the board ,each physician is at a different stage of activation, and we continue to steadily add prescribers.

正如您在發布初期所期望的那樣，我們看到肝病專家由於他們在疾病和 NIT 方面的專業知識而更快地採用。鑑於 NASH 不是他們的主要疾病領域，胃腸病學實踐可能需要更長的時間，並且他們需要考慮患者的實踐動態。總體而言，每位醫生都處於不同的活化階段，我們將繼續穩定增加處方者。

Our top targets are writing more than 75% of prescriptions, giving us conviction that we're targeting the right physicians with our efforts. Significant opportunity remains to expand new prescribers and shifting the initial prescribers to more frequent prescribers. To do this well, we need to continue to successfully wire the system as noted on slide 5. We're in the early stages of what we expect to be about a 12-month process to substantially accomplish that goal.

我們的首要目標是開出超過 75% 的處方，這讓我們確信我們的努力瞄準的是合適的醫生。擴大新的處方者並將最初的處方者轉變為更頻繁的處方者仍然存在重大機會。為了做好這一點，我們需要繼續成功地連接系統，如幻燈片 5 所示。我們正處於我們預計將持續 12 個月才能實質實現這一目標的早期階段。

Just like other disease states with first time treatments, we are working to change physician behavior and help build a pathway to efficiently process Rezdiffra prescriptions at physicians' offices. We've made great progress, we are steadily adding patients and prescribers, but it's early in the launch, and there's still a lot of work to do.

就像其他首次治療的疾病狀態一樣，我們正在努力改變醫生的行為，並幫助建立一條在醫生辦公室有效處理 Rezdiffra 處方的途徑。我們已經取得了很大進展，我們正在穩步增加患者和處方者，但現在還處於啟動初期，仍有許多工作要做。

For physicians, it's about educating on the risks of NASH and activating them to write a prescription. The risks are real and they are urgent. For example, our health economic study of an Optum claims database highlights alarming rates of progression to adverse liver related outcomes. Of 19,000 NASH patients without cirrhosis at baseline, approximately 17% progressed to decompensated cirrhosis within three years.

對於醫生來說，這是關於 NASH 風險的教育並激勵他們開處方。風險是真實存在的，而且是緊迫的。例如，我們對 Optum 索賠資料庫的健康經濟學研究強調了與肝臟相關的不良後果的進展速度令人震驚。在 19,000 名基線時沒有肝硬化的 NASH 患者中，約 17% 在三年內進展為失代償性肝硬化。

In addition to disease state and Rezdiffra education, we are also helping physicians identify the appropriate patients for Rezdiffra using NITs as well as using the recently published US expert panel recommendations and EASL guidelines. For the office staff, It's about helping practices create a pathway to process patients and prescriptions to handle the future volume we anticipate.

除了疾病狀態和 Rezdiffra 教育之外，我們還使用 NIT 以及最近發布的美國專家小組建議和 EASL 指南來幫助醫生確定適合 Rezdiffra 的患者。對於辦公室工作人員來說，這是為了幫助實踐創建一條處理患者和處方的途徑，以處理我們預期的未來數量。

This could require additional staff to manage patients and navigate the evolving reimbursement process. For payers we continue to have productive dialogue on the costs of NASH, the clinical benefits of Rezdiffra and noninvasive testing of patients that's been paying off with favorable risk, different coverage. And for patients were continuing to educate them on NASH and Rezdiffra while helping them navigate through the complexities of the health care system to support their treatment journey.

這可能需要額外的人員來管理患者並應對不斷變化的報銷流程。對於付款人，我們繼續就 NASH 的成本、Rezdiffra 的臨床益處以及患者的非侵入性檢測進行富有成效的對話，這些檢測以有利的風險和不同的承保範圍獲得了回報。對於患者來說，我們繼續對他們進行 NASH 和 Rezdiffra 的教育，同時幫助他們應對醫療保健系統的複雜性，以支持他們的治療之旅。

So we're absolutely doing the work physician by physician, practice by practice, payer by payer, and patient by patient. This is a tailored approach that requires discipline, repetition and time. As accounts become wired, the pull through process becomes smoother and it's easier to send more prescriptions through. We're still in the early stages, but we are confident that we're building the foundation needed to create a blockbuster medicine.

因此，我們絕對是在逐個醫生、逐一實踐、逐一付款人、逐個患者地開展工作。這是一種量身定制的方法，需要紀律、重複和時間。隨著帳戶轉為電匯，傳遞過程變得更加順暢，更容易發送更多處方。我們仍處於早期階段，但我們有信心為創造重磅藥物奠定基礎。

The optimism of our US launch drives our decision to directly commercialize Rezdiffra in Europe as noted on slide 6. We have been evaluating our Europe strategy following the submission of our marketing application earlier this year. We expect an EMA decision midyear next year, which would make Rezdiffra the first NASH treatment available in Europe. Our decision to commercialize the commercialized Rezdiffra in Europe allows us to preserve the full value of the asset, maintain strategic flexibility and create a platform for future growth.

如投影片 6 所示，我們在美國推出 Rezdiffra 的樂觀情緒促使我們決定直接在歐洲將 Rezdiffra 商業化。在今年稍早提交行銷申請後，我們一直在評估我們的歐洲策略。我們預計 EMA 將於明年年中做出決定，這將使 Rezdiffra 成為歐洲第一個可用的 NASH 治療藥物。我們決定在歐洲將商業化的 Rezdiffra 商業化，這使我們能夠保留資產的全部價值，保持策略靈活性並為未來成長創造平台。

Europe is an attractive opportunity for several reasons. For NASH patient population in Europe is significant, NASH is driving a marked increase in the prevalence of hepatocellular carcinoma in Europe. From 2016 to 2030 cases of NASH related HCC are expected to increase by more than 100%. We've established Rezdiffra as a potentially foundational therapy in NASH through our Maestro NASH Phase 3 clinical trial. We have 125 trial sites in Europe.

出於多種原因，歐洲是一個有吸引力的機會。對於歐洲的 NASH 患者群體來說，NASH 正在推動歐洲肝細胞癌盛行率的顯著增加。從 2016 年到 2030 年，NASH 相關 HCC 病例預計將增加 100% 以上。透過 Maestro NASH 3 期臨床試驗，我們已將 Rezdiffra 確定為 NASH 的潛在基礎療法。我們在歐洲有 125 個試驗點。

We formed strong relationships with the NASH European community through our clinical development program and on the ground presence with our European medical affairs team. And Rezdiffra has been favorably very favorably positioned as first-line therapy for moderate to advanced NASH, consistent with F2/F3 fibrosis in the EASL clinical practice guidelines.

透過我們的臨床開發計劃以及與歐洲醫療事務團隊的實地合作，我們與 NASH 歐洲社區建立了牢固的關係。Rezdiffra 已被非常有利地定位為中度至晚期 NASH 的一線療法，與 EASL 臨床實踐指南中的 F2/F3 纖維化一致。

This was despite it not being approved yet in Europe. The guidelines also note that Rezdiffra is the only disease specific agent in NASH with positive results from a registrational Phase 3 clinical trial. We are starting to build the infrastructure now to commercialize Rezdiffra in Europe in 2025.

儘管它尚未在歐洲獲得批准。該指南還指出，Rezdiffra 是 NASH 中唯一在註冊 3 期臨床試驗中取得正面結果的疾病特異性藥物。我們現在開始建造基礎設施，以便在 2025 年在歐洲實現 Rezdiffra 的商業化。

Another key aspect of our lifecycle management strategy is expanding the use of Rezdiffra to patients with compensated cirrhosis as seen on slide 7. There is an even higher urgency to treat patients with cirrhosis because they are at a 42 times higher risk for liver-related mortality.

我們生命週期管理策略的另一個關鍵面向是將 Rezdiffra 的使用範圍擴大到代償性肝硬化患者，如投影片 7 所示。治療肝硬化患者更加緊迫，因為他們的肝臟相關死亡率高出 42 倍。

Our Maestro NASH outcomes trial evaluates Rezdiffra in this patient population. It's an event-driven trial that noninvasively measures progression to liver decompensation events in patients with compensated NASH cirrhosis and indication in this patient population has the potential to double our opportunity.

我們的 Maestro NASH 結果試驗評估了 Rezdiffra 在該患者群體中的作用。這是一項事件驅動的試驗，可無創地測量代償性 NASH 肝硬化患者的肝臟失代償事件的進展情況，而該患者群體的適應症有可能使我們的機會加倍。

Let me conclude by summarizing our progress on slide 8. We have the enviable position of being first to market in NASH, giving us a strong and sustainable competitive advantage. We are fully leveraging this opportunity, positioning ourselves for long term leadership in the US and now globally with our expected launch in Europe, we have a highly desirable product profile.

最後，讓我總結一下我們在投影片 8 上的進展。我們擁有率先進入 NASH 市場的令人羨慕的地位，這為我們帶來了強大且可持續的競爭優勢。我們正在充分利用這一機會，將自己定位為在美國的長期領導者，現在隨著我們預計在歐洲的推出，我們將在全球範圍內擁有非常理想的產品概況。

It's an effective once-daily, well-tolerated pill. It's a liver-directed medicine that has demonstrated the ability to hold or improve liver stiffness business in 91% of patients out to three years. And we've resourced the launch to match the opportunity in front of us, starting with an expert team that's launched dozens of blockbuster medicines. While we're still early in the launch, we're making good progress on many metrics.

這是一種有效的每日一次、耐受性良好的藥丸。它是一種針對肝臟的藥物，已被證明能夠在三年內維持或改善 91% 的患者的肝臟僵硬狀況。我們為這次上市提供了資源，以配合我們面前的機會，首先是專家團隊推出了數十種重磅藥物。雖然我們仍處於發布初期，但我們在許多指標上都取得了良好進展。

Net sales of $14.6 million more than 2,000 patients on drug, more than 50% of commercial lives covered virtually all except NIT that do not require biopsies in line with what we have communicated. Approximately 20% of our top targets have prescribed with significant room for growth.

淨銷售額為 1,460 萬美元，超過 2,000 名患者服用藥物，超過 50% 的商業壽命幾乎覆蓋了除 NIT 之外的所有患者，根據我們所傳達的信息，不需要進行活檢。我們大約 20% 的首要目標都規定了龐大的成長空間。

Recently published these guidelines in US expert panel recommendations and Doris Rezdiffra as a first-line therapy for F2/F3 NASH. We have more work to do to change clinical practice to educate and activate physicians and to help them create efficient care pathways for patients.

最近在美國專家小組推薦中發布了這些指南，並將 Doris Rezdiffra 作為 F2/F3 NASH 的一線療法。我們還有更多的工作要做，以改變臨床實踐，教育和激勵醫生，幫助他們為患者創造有效的護理途徑。

We are steadily adding patients and prescribers and tracking right in line with what we would expect at this point in the launch. As we look forward, we are well on our way to building a blockbuster medicine with patient expansion as we execute on the untapped opportunity in F2/F3 NASH indication expansion as we look forward to data from our outcomes trial in cirrhosis patients and geographic expansion as we plan to launch Rezdiffra in Europe next year.

我們正在穩步增加患者和處方者，並按照我們在發佈時的預期進行追蹤。展望未來，我們正在利用 F2/F3 NASH 適應症擴展中尚未開發的機會，透過患者擴展來打造一款重磅藥物，同時我們期待著肝硬化患者結果試驗和地理擴展的數據。推出Rezdiffra。

Before I turn the call over to Mardi, let me briefly reflect on the progress we've made as a company. I've been in my role 11 months, and what we've accomplished is pretty incredible. I'm very proud of this team. The FDA accepted the Rezdiffra filing, we received priority review, no AdCom was required. We very quickly build an expert team at the leadership level and at the commercial level, including a full field team ready to support the launch on day one.

在將電話轉給 Mardi 之前，讓我先簡單回顧一下我們作為一家公司所取得的進展。我擔任這個職務已經 11 個月了，我們所取得的成就令人難以置信。我為這個團隊感到非常自豪。FDA 接受了 Rezdiffra 備案，我們獲得了優先審查，不需要 AdCom。我們很快就在領導層和商業層面建立了一個專家團隊，包括準備在第一天支持啟動的完整現場團隊。

We built sufficient supply, we received approval with a best case label. Importantly, with no biopsy requirement. The team was out promoting Rezdiffra within weeks of approval and we shipped product in less than a month. We have been building strong physician relationships. We've seen favorable Rezdiffra guidelines published.

我們建立了充足的供應，並獲得了最佳案例標籤的批准。重要的是，無需活檢。團隊在獲得批准後幾週內就開始推廣 Rezdiffra，我們在不到一個月的時間內就出貨了產品。我們一直在建立牢固的醫生關係。我們已經看到了有利的 Rezdiffra 指南的發布。

Payer coverage is favorable and virtually all plans not requiring a biopsy. So we are executing on everything that we said we would. We're making progress, it's early and there's still more work to do. As we look forward, we have, but we are about one-third of the way through our plans to wire the system to build a strong foundation to support our aspiration for peak sales. We have the right strategy in place to do that, and we're even more confident in the significant potential of Rezdiffra.

付款人承保範圍是有利的，幾乎所有計劃都不需要活檢。因此，我們正在執行我們所說的一切。我們正在取得進展，但現在還為時過早，還有更多工作要做。正如我們所期望的那樣，我們已經做到了，但我們的系統連接計劃已完成大約三分之一，以建立堅實的基礎來支持我們對高峰銷售的渴望。我們已經制定了正確的策略來做到這一點，我們對 Rezdiffra 的巨大潛力更加充滿信心。

So with that, Mardi?

那麼，瑪迪？

Yes, thank you, Bill. The press release we issued earlier today contains our full financial results, so I will provide a few highlights as noted on slide 9 for the second quarter of 2024. US net product sales for the quarter were $14.6 million, comprised of demand and inventory.

是的，謝謝你，比爾。我們今天早些時候發布的新聞稿包含我們的完整財務業績，因此我將提供幻燈片 9 中提到的 2024 年第二季度的一些要點。本季美國產品淨銷售額為 1,460 萬美元，包括需求和庫存。

For the quarter, it was mostly demand. We expect inventory to run between two to four weeks for Rezdiffra, as is typical for a specialty medicine. Gross-to-net was favorable to our expectations for the quarter as our co-pay assistance was lower than anticipated for this particular quarter. As we said, we expect gross-to-net to be choppy quarter to quarter, particularly this early in the launch.

本季主要是需求。我們預計 Rezdiffra 的庫存將持續兩到四個星期，這對於特殊藥物來說是典型的情況。由於我們的自付額援助低於本季度的預期，因此總淨額對我們的預期有利。正如我們所說，我們預計毛淨比將出現季度波動，尤其是在發布初期。

R&D expenses for the second quarter 2024 were $71.1 million compared to $68.6 million in the second quarter of 2023. We continue to anticipate a relatively steady level of R&D expenses for the rest of the year. SG&A for $105.4 million compared to $17.8 million for the second quarter of 2023.

2024 年第二季的研發費用為 7,110 萬美元，而 2023 年第二季的研發費用為 6,860 萬美元。我們繼續預計今年剩餘時間的研發費用將保持相對穩定的水平。SG&A 為 1.054 億美元，而 2023 年第二季為 1780 萬美元。

This year over year increase is as expected, as we discussed last quarter due to the scale-up of our commercial operations following the March approval of Rezdiffra. With the announcement of our intent to launch Rezdiffra in Europe, we expect a modest increase to related to our infrastructure build in 2024 and more so in 2025.

正如我們在上個季度討論的那樣，由於 Rezdiffra 3 月獲得批准後我們的商業營運規模擴大，同比增長符合預期。隨著我們宣布打算在歐洲推出 Rezdiffra，我們預計 2024 年基礎建設將帶來小幅成長，2025 年更是如此。

Moving to our balance sheet, the balance of our cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024, stood at $1.1 billion, which is slightly higher than what we reported last quarter due to the closing of the green shoe from our March public offering and proceeds from option exercises. With our strong cash position, we are well resourced to support a successful multiyear launch of Rezdiffra.

轉向我們的資產負債表，截至 2024 年 6 月 30 日，我們的現金、現金等價物、受限制現金和有價證券餘額為 11 億美元，略高於我們上季度報告的水平，原因是綠鞋關閉來自我們三月的公開發行和選擇權行使的收益。憑藉我們強大的現金狀況，我們擁有充足的資源來支持 Rezdiffra 的多年成功推出。

I'll now turn the call back over to Tina.

我現在將把電話轉回給蒂娜。

Thanks, Mardi. We will now open the call for questions. (Event Instructions)

謝謝，瑪迪。我們現在開始提問。（活動須知）

Malala, if you could open the call.

馬拉拉，如果你能接通電話的話。

We will now open the lines for question-and-answers. (Operator Instructions)

我們現在將開放問答熱線。（操作員說明）

Thomas Smith, Leerink Partners.

托馬斯史密斯，Leerink 合夥人。

Hi, guys, good morning. Thanks for taking the questions and congrats on the nice launch quarter. I was just wondering if you could -- I appreciate all the color in the prepared remarks. Just wondering if you could just elaborate and maybe quantify a little bit more within that $14.6 million of net revenues. How much of that was due to underlying patient demand and prescriptions being delayed versus how much of that was related to initial inventory and stocking? Thanks.

嗨，夥計們，早安。感謝您提出問題，並恭喜發布季度的順利進行。我只是想知道你是否可以——我很欣賞準備好的評論中的所有色彩。只是想知道您是否可以在這 1460 萬美元的淨收入中詳細說明並量化一下。其中有多少是由於潛在的患者需求和處方延遲造成的，有多少是與初始庫存和庫存有關？謝謝。

Great. Tom. Thanks, Mardi?

偉大的。湯姆.謝謝，瑪迪？

Yes, great, Tom. Great question. How we're going to characterize it characterize the demand versus inventory. And the $14.6 million in net sales is that it's mostly demand for this quarter. So we're really pleased how our team performed cross-functionally and had a nice result for the quarter. However, we just want to reiterate that the typical days on hand for inventory moving forward is two to four weeks as we've seen with most specialty medicines.

是的，太好了，湯姆。很好的問題。我們將如何描述它的特徵，即描述需求與庫存的關係。1460 萬美元的淨銷售額主要是本季的需求。因此，我們非常高興我們的團隊跨職能的表現並在本季度取得了不錯的成績。然而，我們只是想重申，正如我們在大多數特種藥物中所看到的那樣，庫存的典型可用天數為兩到四週。

We also want to reiterate that we're at the beginning stages of our launch, right? We're about one-third of the way through what we think we need to wire the system. So we just want everyone to be careful not to get ahead of ourselves as we look forward in the next quarter.

我們也想重申，我們正處於發布的開始階段，對嗎？我們認為系統連接所需的工作已完成約三分之一。因此，我們只是希望每個人在展望下個季度時都小心不要超前。

And I'll just make one other point that Bill made, very clearly that looking forward on, we had nice progress into our launch quarter, and that will steadily add both patients and prescribers as we move forward.

我只想提出比爾提出的另一點，非常明確的是，展望未來，我們在發布季度取得了很好的進展，隨著我們的前進，患者和處方者將穩步增加。

Great. Thanks, Tom. Malala next question, please.

偉大的。謝謝，湯姆。請馬拉拉提出下一個問題。

Andrea Tan, Goldman Sachs.

安德里亞·譚，高盛。

Good morning. Thanks for taking our questions. Maybe given the focus on the launch cadence here. Just wondering if you're able to provide an update on patient numbers exiting July? I know you have that over 2000 as of the end of the quarter and then what proportion are on unpaid drug? Thank you.

早安.感謝您回答我們的問題。也許是因為這裡關注的是啟動節奏。只是想知道您是否能夠提供 7 月退出的患者人數的最新資訊？我知道截至本季末您有超過 2000 人，那麼無償藥品的比例是多少？謝謝。

Yes, thanks for the question, Andrea. Look, we're not going to talk about month-to-month progression. I think the way we've characterized it is that we're steadily adding patients and prescribers, and that was certainly what we continued to see through July. And as it relates to free drug and there was a very little this quarter. As we look towards the future, though, we expect that there will be some more free drug as we have more patients utilizing the various services that we provide.

是的，謝謝你的提問，安德里亞。聽著，我們不會談論逐月的進展。我認為我們的特點是我們正在穩步增加患者和處方者，這肯定是我們在 7 月繼續看到的情況。由於涉及免費藥品，本季的免費藥品非常少。然而，展望未來，我們預計將會有更多的免費藥物，因為我們有更多的患者使用我們提供的各種服務。

Great. Thanks.

偉大的。謝謝。

Thanks, Andrea. Malala next question, please.

謝謝，安德里亞。請馬拉拉提出下一個問題。

Akash Tewari, Jefferies.

阿卡什·特瓦里，杰弗里斯。

Hey, this is Amy on for Akash. Thanks so much for taking our question. And so there is an inflection implied by consensus on Rezdiffra revenues next year. Do you feel like there will be a significant acceleration on launch trajectory next year once access is properly in line or is your base case that launch will be more gradual? And then if I could just sneak in one more. Of the less than 5% plans that require biopsy. Can you give us a sense of the plans what they are and the covered lives? Are these mostly Medicare? Thanks so much.

嘿，這是阿卡什的艾米。非常感謝您提出我們的問題。因此，對明年 Rezdiffra 收入的共識暗示了一種變化。您是否認為一旦訪問正確，明年的發布軌跡將會顯著加速，或者您的基本情況是發布將更加漸進？如果我能再偷偷溜進去一次就好了。不到 5% 的計劃需要活檢。您能為我們介紹一下這些計劃是什麼以及涵蓋的生活嗎？這些主要是醫療保險嗎？非常感謝。

Sorry, with the last one, what we are talking about was commercial covered lives, not Medicare. But I guess Medicare, we will have come online in January. So just to be clear, the greater than 50% is commercial covered lives. So that's what those are the stats around it.

抱歉，最後一項，我們談論的是商業保險人壽，而不是醫療保險。但我想醫療保險，我們將在一月上線。需要明確的是，超過 50% 的人壽保險屬於商業保險。這就是圍繞它的統計數據。

Regarding the uptake. Now, look, I think what we've been really clear about from the beginning is that we have to wire the system and that it takes time when you're launching a first-in disease product in a community that's never had anything including anything that they went to really in an off-label capacity.

關於吸收。現在，看，我認為我們從一開始就非常清楚的是，我們必須連接系統，並且當你在一個從未有過任何東西（包括任何東西）的社區中推出首個疾病產品時，這需要時間他們確實以標籤外的身份進行了治療。

And we've said that is about a 12-month process where about a third away, we're about a third of the way through that for now. Now as we have we move through Q4 of this year. Remember, then you get into Q1 of next year and there's always the reset in Q1.

我們說過，這大約是一個 12 個月的過程，還有大約三分之一，目前我們已經完成了大約三分之一。現在我們已經進入了今年的第四季。請記住，當您進入明年的第一季時，第一季總會有重置。

So we're -- that's why we've talked about the 12 months through Q1 of '25. And by the end of that time, we'll have our reimbursement. We feel in place we will have a physician practices that have been trained and just much more comfortable with writing a prescription and pulling it through.

所以我們——這就是為什麼我們討論了 25 年第一季之前的 12 個月。到那時，我們將得到報銷。我們覺得我們將擁有一位經過培訓的醫生，他們在開處方和執行處方方面會更加自如。

So that's when we expect to see that more patients we believe will be able to move us through practices, both from a identification and just ease of ushering them through the whole process.

因此，我們希望看到更多的患者能夠引導我們完成實踐，無論是識別還是引導他們完成整個過程。

Great. Wonderful, thanks, Amy. Next question, please.

偉大的。太棒了，謝謝，艾米。請下一個問題。

Andy Chen, Wolf Research.

安迪陳，沃爾夫研究中心。

Thank you for taking the question and congratulations on the quarter. So if you can remind me based on your market research among the 350,000 patients. What percentage of them are GLP-1 experienced? I'm thinking about a very hypothetical scenario where payers require GLP-1 step. I know that's not the case right now, but please entertain you for a moment. What fraction of these patients was basically bypass that requirement right off the bat? Thank you.

感謝您提出問題並對本季表示祝賀。因此，您能否根據您對 350,000 名患者的市場調查提醒我。其中有多少百分比具有 GLP-1 經驗？我正在考慮一個非常假設的場景，即付款人需要 GLP-1 步驟。我知道現在情況並非如此，但請招待您一會兒。這些患者中有多少比例基本上立即繞過了這項要求？謝謝。

Patient experience, Andy? Or do you say physicians have experience with GLP-1s.

病人的經歷，安迪？或是你說醫生有使用 GLP-1 的經驗嗎？

A patient experience like pay in the past, they have used it, yeah.

過去像付費這樣的患者體驗，他們已經使用過，是的。

Yeah look, we're seeing and we're hearing from practices that there's more patients that have been exposed at some point with GLP-1. As you know, even in our clinical trial, we had 14% of patients that were on GLP-1. Now that was on the diabetes dose. So I'll remind you, however, we're certainly hearing that more patients are being exposed to GLP-1.

是的，我們從實踐中看到並聽到有更多的患者在某個時候接觸過 GLP-1。如您所知，即使在我們的臨床試驗中，我們也有 14% 的患者服用 GLP-1。現在是糖尿病劑量。不過，我要提醒您，我們確實聽說有越來越多的患者接觸 GLP-1。

Question always is when were they exposed was it 1 month ago, 6 months ago or 12 months ago, are they still on and -- as you know, with the discontinuation rates, it could be any of those answers. So what we're seeing from our own data is that there are some patients that are concomitantly on a GLP-1, but it's still pretty early and it's tough to get some of that information right now. Regarding payers, we haven't seen anyone requiring a step-through GLP-1.

問題始終是他們什麼時候暴露的，是 1 個月前、6 個月前還是 12 個月前，他們還在繼續嗎？因此，我們從自己的數據中看到，有些患者正在同時服用 GLP-1，但現在還為時過早，現在很難獲得其中一些資訊。關於付款人，我們還沒有看到任何人需要逐步執行 GLP-1。

Thank you.

謝謝。

Good things. Malala our next question, please.

好東西。請馬拉拉回答我們的下一個問題。

Elliana Merle, UBS.

艾莉安娜梅爾，瑞銀。

Thanks for taking the question and congrats on the progress. You mentioned that you are seeing faster uptake with hepatologists versus gastroenterologists. Can you just give us a little bit more color on the latest trends that you're seeing with the gastros now versus at the start of the launch? And if you're seeing an uptick in our uptick in prescribing from the gastroenterology segment? Thanks.

感謝您提出問題並祝賀取得的進展。您提到您發現肝病專家比胃腸病專家的接受速度更快。您能否給我們更多關於您現在看到的美食趨勢與發布之初的最新趨勢的資訊？如果您看到我們胃腸病學領域的處方量增加？謝謝。

Yeah, Eli, thanks for the question. So I mean, look, it makes sense that hepatologists are going to get off to a little bit faster start, right? They have been treating the disease. That's something that they know very well. They're familiar very familiar with liver. And so we did see the hepatologists get started a little quicker.

是的，伊萊，謝謝你的提問。所以我的意思是，看，肝病學家的起步速度會更快一點，這是有道理的，對嗎？他們一直在治療這種疾病。這是他們非常了解的事情。他們對肝臟非常熟悉。所以我們確實看到肝病學家開始得更快一些。

Now the gastroenterologists, there's a lot more of them than hepatologists and they're working through their practice dynamics as well. As you know, there's a pretty high focus on scoping in gastroenterology.

現在，胃腸病學家的數量比肝病學家多得多，而且他們也在研究他們的實踐動態。如您所知，人們非常關注胃腸病學的範圍界定。

So it's how do they make room in their practice or how will they process a patient using oftentimes a lot of ACPs and they are at different stages of how do they actually process a patient through, great interest in doing so, but there's just a practical matter that you're running a practice and you now have to start to make room for that.

因此，問題是他們如何在實踐中騰出空間，或者如何經常使用大量 ACP 來治療患者，而且他們處於如何實際治療患者的不同階段，對此非常感興趣，但只有一個實用的方法不管你正在進行練習，你現在都必須開始為此騰出空間。

And that's what we're spending time doing is working with them. Now there's a lot of gastroenterologists that are writing. We talked about 20% of our target list and the majority of that target list is gastroenterologists because there's just not that many hepatologists in the country. So we expect that gastroenterologists are going to be a key prescriber in this because there's so many, and that's where the bulk of the patients sit.

這就是我們花時間與他們合作的事情。現在有很多胃腸病學家正在寫作。我們談到了 20% 的目標名單，其中大部分是胃腸病學家，因為全國沒有那麼多肝病專家。因此，我們預計胃腸病學家將成為這方面的關鍵處方者，因為人數太多，而且大多數患者都坐在那裡。

And just as we expected, hepatology a little bit ahead, but gastroenterology making progress and as we said from the beginning, we're steadily adding new prescribers and steadily adding patients.

正如我們所預期的那樣，肝病學稍微領先，但胃腸病學正在取得進展，正如我們從一開始所說的那樣，我們正在穩步增加新的處方者並穩步增加患者。

Great. Thank Eli for the question. Malala, next question, please.

偉大的。感謝伊萊的提問。馬拉拉，請下一個問題。

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

And yes, team, congrats really on a solid quarter and all the great work. I guess you commented now that you're thinking about for 2025 and expansion into Europe as well into cirrhotic patients. Could you maybe think about is your plans in Europe to really do this on your own and build a commercial sales force or are you still between now and end of year potentially entertaining general a partnership and that could allow them to commercialize and you could focus on the US.

是的，團隊，衷心祝賀本季的穩健表現和所有出色的工作。我想您現在評論說您正在考慮 2025 年並將業務擴展到歐洲以及肝硬化患者。您是否可以考慮一下您在歐洲的計劃是否真正自己做到這一點並建立一支商業銷售隊伍，或者您是否仍在從現在到年底之間建立潛在的合作夥伴關係，這可以讓他們商業化，您可以專注於美國。

So we'd love for you to maybe think about how we should be thinking about that just because it's its own P&L, its own caveats involved in Europe. So would love being out like are you fully committed? Do you want to partner? What are your thoughts are there?

因此，我們希望您能夠考慮我們應該如何考慮這一點，因為它是它自己的損益表，它自己涉及歐洲的警告。那麼你是否願意外出，就像你全心投入一樣？你想合作嗎？你有什麼想法？

Yeah, thanks very much for the question. Let me provide the clarification. We're fully committed to commercializing on our own in Europe. First of all, I've commercialized multiple products in Europe. In fact, every product that commercialized has been globally, we have a team that has done that as well. So we feel like we're extremely well positioned to do so.

是的，非常感謝你的提問。讓我來澄清一下。我們完全致力於在歐洲自行商業化。首先，我已經在歐洲將多種產品商業化。事實上，每一個商業化的產品都已經走向全球，我們也有一個團隊做到了這一點。所以我們覺得我們完全有能力做到這一點。

Now what's the ingredients to doing that? What we did here is it with the whole leadership team as we built the right team and put them in place so that they could execute to do they know what to do. That's the same thing that we're going to be doing in Europe. We will be very focused targeted in the way that we launch likely starting point is Germany.

現在要做到這一點的要素是什麼？我們在這裡所做的是與整個領導團隊一起建立合適的團隊並將他們安排到位，以便他們可以執行他們知道該做什麼。這與我們將在歐洲做的事情是一樣的。我們將非常專注於我們推出的方式，可能的起點是德國。

And one of the things that we learned or several of the things that we've learned. If I look at Europe and a lot of it's coming off of our experience being their utilized as well. There's real excitement in Europe for the drug. And I would say if I look back at a year ago, though, I wasn't here exactly a year ago, but a year ago for approval in Europe versus the US.

以及我們學到的一件事或我們學到的幾件事。如果我看看歐洲，很多都是來自我們的經驗，他們也利用了我們的經驗。歐洲對這種藥物非常興奮。不過，我想說，如果我回顧一年前，我並不是一年前來到這裡，而是一年前在歐洲與美國進行批准。

In the US because there had been so many failures before. There was this question will Rezdiffra get approved and a lot of the physicians didn't take action until post approval. And when they said that they weren't going to take action, they really meant it. And they were waiting for the product was approved.

在美國，因為之前有過很多失敗的案例。有人問 Rezdiffra 是否會獲得批准，許多醫生直到批准後才採取行動。當他們說不打算採取行動時，他們是真心實意的。他們正在等待產品獲得批准。

Europe, there is, I would say, greater certainty for them because they believe that the US approval is a good prognosticator for approval in Europe. And at EASL, we certainly heard that people were taking steps. We saw that leadership in Europe got very well organized and had the EASL guidelines out well in advance of approval.

我想說，歐洲對他們來說有更大的確定性，因為他們相信美國的批准是歐洲批准的良好預測。在 EASL，我們當然聽說人們正在採取措施。我們看到歐洲的領導層組織得非常好，並且在批准之前就已經制定了 EASL 指南。

And despite not even being approved, put Rezdiffra in the lead position there. So we think that Europe as well as the 125 trial sites that we've had there is quite experienced with NOS Rezdiffra is excited about it. But we are going to be very disciplined in the way that we approach out of Europe and we'll be able to give you a little bit more updates on it as we progress throughout the year to tell you exactly how we're going about that launch.

儘管沒有獲得批准，Rezdiffra 仍處於領先地位。因此，我們認為歐洲以及我們在那裡擁有的 125 個試驗點對 NOS Rezdiffra 非常有經驗，對此感到興奮。但我們在走出歐洲的方式上將非常自律，隨著我們全年的進展，我們將能夠為您提供更多更新信息，準確地告訴您我們將如何開展這方面的工作。

Next question, Malala.

下一個問題，馬拉拉。

Liisa Bayko, Evercore ISI.

莉莎·貝科，Evercore ISI。

Hi. Thanks for taking the question. I'm wondering if you could give us a view on patient start forms at the end of the quarter. And then also just a little more color on gross to net. I know you said it would be a little choppy and maybe a sense of what it was and then where you ultimately want to get to? Thanks.

你好。感謝您提出問題。我想知道您是否可以在季度末向我們提供有關患者開始表格的看法。然後在總淨值上再增加一點顏色。我知道你說過這會有點不穩定，也許你會感覺到它是什麼，然後你最終想要到達哪裡？謝謝。

Lisa, thank you very much for the question. Let me start just with the with the patient start forms, we're not giving an update of the patient start forms. We are just providing these patients that were on drug at the end of the quarter. And glad to say, though that there are clearly we're seeing steady additions to patients. And as I said, prescribers throughout the quarter and since the quarter. Maybe from a gross-to-net perspective, Mardi, I'll have you.

麗莎，非常感謝你的提問。讓我從患者開始表格開始，我們不會提供患者開始表格的更新。我們只是為這些在季度末服用藥物的患者提供服務。很高興地說，儘管我們顯然看到患者數量穩定增加。正如我所說，整個季度和本季以來的處方者。也許從整體到網路的角度來看，Mardi，我會擁有你。

Yeah, absolutely. Thanks, Lisa for the question. So our second quarter, our first quarter of launch gross-to-net was favorable versus our expectations. But it's all within the realm of what would be typical for a specialty product. We want to be clear about that. Sort of the biggest swing factor for us right now is the co-pay assistance program that we've set up to make sure that we can get and help our patients get on drug as efficiently as possible.

是的，絕對是。謝謝麗莎的提問。因此，我們第二季、第一季的發布總淨值比我們的預期有利。但這一切都屬於特種產品的典型範圍。我們想澄清這一點。目前對我們來說最大的搖擺因素是我們設立的共同支付援助計劃，以確保我們能夠盡可能有效地獲得並幫助我們的患者獲得藥物。

We saw less use of our co-pay assistance program this quarter. But going forward, we expect that to grow a little bit. So that was sort of the essence of gross-to-net could be choppy. And then, of course, as you get into first quarter, you have other issues with gross-to-net and IRA, et cetera. But that was the main driver for this quarter.

本季我們的共同支付援助計劃的使用較少。但展望未來，我們預期這一數字會有所成長。這就是總淨值的本質可能是不穩定的。然後，當然，當你進入第一季時，你會遇到其他與毛淨額和 IRA 等有關的問題。但這是本季的主要驅動力。

Well. The next question, please.

出色地。請下一個問題。

Ritu Baral, TD Cowen.

裡圖·巴拉爾，TD·考恩。

Good morning, guys. Thanks for taking the question. I wanted to ask a little bit more about the prior ops that you're seeing for the plans that have established coverage and our own survey work and KOL work indicates there's a lot of MRE imaging and maybe MRI-PDFF diagnostic imaging required.

早安，夥計們。感謝您提出問題。我想多問一些關於您所看到的已建立覆蓋範圍的計劃的先前操作以及我們自己的調查工作和 KOL 工作表明需要大量 MRE 成像，可能還需要 MRI-PDFF 診斷成像。

And can you talk about access and what you guys are doing to assist access to those imaging technologies for diagnosis? And is that consistent with the prior authorization requirements, diagnostic requirements that you guys are seeing in your finalized plans? Thanks.

您能談談訪問情況以及您正在做什麼來幫助訪問這些成像技術進行診斷嗎？這與你們在最終計劃中看到的事先授權要求、診斷要求一致嗎？謝謝。

Well, thank you very much for the question, Ritu. We are not seeing access to any of the NITs as being problematic. And in fact, we're really happy with what we're seeing as requirements. Most of them include imaging asked, but blood tests as well for the imaging fiber scan, MRI, MRI-PDFF. And then we also have the health and fit for from a blood test perspective.

好吧，非常感謝你提出這個問題，Ritu。我們不認為存取任何 NIT 存在問題。事實上，我們對我們所看到的要求非常滿意。其中大多數包括影像詢問，但血液檢查以及成像纖維掃描、MRI、MRI-PDFF。然後，從血液檢查的角度來看，我們還可以了解健康狀況和適合度。

So it does vary, but there hasn't been anything that's been concerning, I would say. And as we map out the access that physicians have to these various technologies they have. They have very good access now is it perfect as everyone have access to everything? I know, but we're at the very beginning here and as I said, as it relates to NITs, I think it's going to be a three-year process for NITs to sort themselves out. There isn't complete alignment in the physician community about which combos to use.

所以它確實有所不同，但我想說，沒有任何令人擔憂的事情。當我們規劃出醫生可以使用他們所擁有的各種技術。他們現在擁有非常好的訪問權限，因為每個人都可以訪問所有內容，這是否完美？我知道，但我們正處於起步階段，正如我所說，由於這與 NIT 相關，我認為 NIT 需要花費三年的時間來解決問題。對於使用哪些組合，醫師界並沒有完全一致。

There's new technologies that people are thinking about as well. So I think it's going to take a few years before there is just real well, there may never be alignment, but I think that there's going to be better information to say what is the combinations and sequencing that are going to be best for us for various physicians.

人們也在考慮新技術。所以我認為需要幾年的時間才能真正實現一致，可能永遠不會對齊，但我認為會有更好的資訊來說明什麼是最適合我們的組合和測序各種醫生。

So we think we're in a really good place. As you recall, the big concern out there was our biopsy is going to be required and that just has not been the case. We talked about less than 5%. And now and going back to this wiring the system, the challenge for practices is where historically they just had to stage somebody and watch and wait now they have to actually stage somebody as they're deciding to treat with Rezdiffra and it's one thing to do it for staging.

所以我們認為我們處於一個非常好的位置。正如您所記得的，人們最擔心的是我們需要進行活檢，但事實並非如此。我們談到了不到5%。現在回到系統佈線，實踐面臨的挑戰是，過去他們只需要安排某人並觀看並等待，現在他們必須在決定使用 Rezdiffra 治療時實際安排某人，這是要做的一件事它用於舞台。

It's another thing when you start thinking about the implementation of a pathway which leads to the prescription of Rezdiffra. And that is kind of the muscle memory talk memory. We talk about where practices are getting, is that the more they do it, the easier it is so that it becomes more of a behavior change rather than a curiosity or going and trying to find a high priority patient. And that's what takes the time here to get us to that steady-state.

當你開始考慮實施一條通往 Rezdiffra 處方的途徑時，那就是另一回事了。這就是肌肉記憶談話記憶。我們談論實踐的進展，就是他們做得越多，就越容易，這樣它就更多地變成一種行為改變，而不是出於好奇或試圖尋找高優先級患者。這就是我們需要花時間讓我們達到穩定狀態的原因。

And thanks Ritu. Next question, please.

感謝瑞圖。請下一個問題。

David Lebowitz, Citi.

大衛‧勒博維茨，花旗銀行。

Thank you very much for taking my question. You had indicated the time to fill was coming in faster than the original expectations of starting at 60 days and eventually dropping 30 days. Are we to assume that it's in between 30 to 60 days, this more this point than it has actually already reached 30 days or potentially is exceeding 30 days?

非常感謝您回答我的問題。您曾表示，填補時間比原先預期的快，最初預期為 60 天，最終縮短為 30 天。我們是否假設它在 30 到 60 天之間，這比實際上已經達到 30 天或可能超過 30 天還要多？

David, thank you for the question. And maybe just a little bit of context. First is, as we were out starting the launch from one of the real directions to the field was to help practices with patient selection. And that was very conscious effort. The reason being is we've been clear from the beginning saying that we want only F2/F3 patients, and that's been a partnership with the payers to letting them know that we're not trying to expand on either side until we have data.

大衛，謝謝你的提問。也許只是一點背景資訊。首先，當我們開始啟動時，該領域的真正方向之一是幫助患者選擇實踐。這是非常有意識的努力。原因是我們從一開始就明確表示我們只想要 F2/F3 患者，而這是與付款人的合作，讓他們知道在我們獲得數據之前我們不會試圖在任何一方進行擴張。

And I think this is a testament to the team's doing a really great job in that the practices chose the right patient, so that their experience in gaining access, even if it was a temporary policy in place, it actually moved quicker.

我認為這證明了團隊做得非常出色，因為這些實踐選擇了正確的患者，因此他們在獲得准入方面的經驗，即使這是一項臨時政策，實際上進展得更快。

I think it's also an acknowledgment that the payers see the unmet need and they don't want to deny a patient that really needs the drug either to get this. They know what happens when a patient crosses the line to cirrhosis. It's just not good.

我認為這也是一種承認，即付款人看到了未滿足的需求，他們不想拒絕真正需要藥物的患者獲得這種藥物。他們知道當患者越過肝硬化界限時會發生什麼。這只是不好。

So that's how I think that explains why there has been that acceleration, if you will. It was kind of deliberate to make sure we have the right patient and also the practices wanting to make sure that they only had so many resources in time. They didn't want to get stuck having to fight back and forth. So they chose the right patients as well.

如果你願意的話，我認為這就是為什麼會出現這種加速的原因。這是經過深思熟慮的，以確保我們擁有合適的患者，同時也希望確保他們及時擁有這麼多資源。他們不想陷入來來回回的戰鬥。所以他們也選擇了適合的患者。

Now as we scale this back up and you start putting more volume through probably the quality of the prescription comes in, that can begin to drift a little bit, so you may not be able to move quite as fast. All we've said in the time is that we're directionally closer to 30 than to 60, 60 days.

現在，當我們擴大這個規模，你開始透過處方的品質增加更多的量，這可能會開始有點漂移，所以你可能無法那麼快地行動。我們當時所說的只是我們更接近 30 天，而不是 60、60 天。

Thanks for taking the questions.

感謝您提出問題。

Malala, next question, please.

馬拉拉，請下一個問題。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good morning and thanks for taking my questions. And congrats on this quarter. Just wanted to ask about the COGS $0.6 million initially. I would think for the first few quarters, you're just working off of them prior inventory, when would you expect COGS to normalize? And if you can discuss the rate there? And also on the payers that require a biopsy commercially, could you identify which one of those are and what pressure you think might exist over time for that to change? Thank you.

你好，早安，感謝您回答我的問題。恭喜本季。最初只是想詢問 60 萬美元的銷貨成本。我認為在前幾個季度，您只是在處理之前的庫存，您預計銷貨成本何時會正常化？您可以在那裡討論一下價格嗎？另外，對於需要進行商業活檢的付款人，您能否確定其中哪一個以及您認為隨著時間的推移可能存在哪些壓力來改變這種情況？謝謝。

Ed, thank you very much. I don't have the list in front of me of the payers, and we're not going to get specific to the plans, especially we're still in a pretty dynamic phase right now. We still have some more work to do. Look I think that any of the payers that have required a biopsy are beginning to hear that from prescribers and a lot of cases from patients and advocacy.

艾德，非常感謝你。我面前沒有付款人的名單，我們也不會具體說明計劃，特別是我們現在仍處於一個非常動態的階段。我們還有一些工作要做。看，我認為任何需要活檢的付款人都開始從處方者以及患者和倡導者那裡聽到很多案例。

In a day and age where there are good NITs that allow for the appropriate diagnosis and staging. It's just not necessary to subject somebody to a biopsy, which has its own set of complications. So we would expect over time that those discussions will take place. And we're hopeful that those plans will come around. But remember, we always said that there'd be outliers and as just as we said, there are some outliers out there that are requiring biopsies.

在當今時代，有良好的 NIT 可以進行適當的診斷和分期。只是沒有必要對某人進行活檢，活檢有其自身的一系列併發症。因此，我們預計隨著時間的推移，這些討論將會發生。我們希望這些計劃能夠實現。但請記住，我們總是說會有異常值，正如我們所說，有一些異常值需要進行活檢。

So we'll keep working at it. we don't want any patient to be subject to it, and that is what will drive our engagement with all the payers to make sure that patients are well treated and have an option to have noninvasive tests. On the COGS question, I'll turn that over to Mardi?

所以我們會繼續努力。我們不希望任何患者受到這種影響，這將推動我們與所有付款人的接觸，以確保患者得到良好的治療並可以選擇非侵入性檢查。關於 COGS 問題，我會轉交給 Mardi？

Yeah, thanks for the question Ed. And you are right, COGS is quite low because we are burning off what we have and set up an inventory currently. And we don't think COGS will normalize for another for about a 1.5 year to 2 years from this point really depending on demand on the top line, of course.

是的，謝謝艾德的提問。你是對的，銷貨成本相當低，因為我們正在燒掉現有的庫存並建立庫存。我們認為，從此時起，銷貨成本將在大約 1.5 到 2 年內恢復正常，當然，這實際上取決於營收的需求。

And one thing I would note that we have a small single digit royalty to Roche, which also flows through COGS. So that is a component. But I'll remind you, we're a small molecule medicine. So COGS for Rezdiffra is going to be quite low.

我要指出的一件事是，我們向羅氏收取了少量個位數的特許權使用費，這也透過銷貨成本流動。所以這是一個組件。但我要提醒你，我們是小分子藥物。因此，Rezdiffra 的銷貨成本將相當低。

Great. Thanks so much Ed. Next question Malala?

偉大的。非常感謝艾德。下一個問題馬拉拉？

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Well, hey, congrats on the launch progress and thank you for taking the question. Of your 2000 patients, can you comment on approximate proportions of F2 versus F3? And are you seeing any off-label use in F4s? And then since Bill has the benefit of leveraging his Dupixent launch experience, can you comment on the strategy and timing of communicating directly with patients and how important is the direct-to-patient strategy with NASH, where patients may not be symptomatic compared to other more symptomatic diseases? Thank you.

嗯，嘿，恭喜發布進度，並感謝您提出問題。在您的 2000 名患者中，您能否評論 F2 與 F3 的大致比例？您是否發現 F4 有標籤外使用情況？然後，由於 Bill 受益於他的 Dupixent 上市經驗，您能否評論一下與患者直接溝通的策略和時機，以及 NASH 直接面向患者的策略有多重要，因為與其他患者相比，患者可能沒有症狀更多症狀性疾病？謝謝。

Jay, thanks for the question. On the split of F2 and F3, it's pretty. I think if you were to ask physicians who would they rather start with they've prioritized the patient and say we'd probably want to put an F3 on first. But the reality is you can't control who's coming into your office that day. So they make a decision based upon what's -- how is that patients feel of what is there would be an NIT show, et cetera.

傑伊，謝謝你的提問。F2和F3的分離，很美。我想如果你問醫生他們更願意從誰開始，他們會優先考慮患者並說我們可能想先戴 F3。但現實是您無法控制當天誰會進入您的辦公室。因此，他們根據患者對 NIT 節目的感受如何等做出決定。

So we see we see a balance actually between the two. Regarding off-label, l don't have any real insight into that. We've been very clear with a physician and who is appropriate and who is not appropriate for Rezdiffra and make sure that they understand that we just don't have the data to support. And obviously, it's not in our label, so we would never ask for it or talk about a patient with cirrhosis.

所以我們看到兩者之間實際上達到了平衡。關於標籤外，我對此沒有任何真正的見解。我們已經非常清楚地告訴醫生誰適合、誰不適合 Rezdiffra，並確保他們明白我們只是沒有數據支援。顯然，它不在我們的標籤中，所以我們永遠不會要求它或談論肝硬化患者。

We have no way of really knowing certainly I haven't heard it as being broadly. I think people are really focused on the right patients. And I think that's why, again, we saw a little bit better time to fill and so forth. Regarding the direct-to-patient or the patient education, so we've been educating patients already, but our efforts through more of a direct reach out the DTC perspective, et cetera.

我們無法真正知道，當然我沒有聽說過它是廣泛的。我認為人們真正關注的是正確的患者。我認為這就是為什麼我們再次看到了更好的填補時間等等。關於直接面向患者或患者教育，我們已經在對患者進行教育，但我們的努力更多的是直接接觸 DTC 的觀點，等等。

Those are just about to get started. And I think that it is really important. It's really important when you have a disease that is not well understood, a disease that is not well recognized by many, but a disease that has very serious consequences, as I said, number one cause for liver transplants for women in the United States, staggering statistic.

這些才剛開始。我認為這非常重要。當你患有一種尚未被充分了解的疾病時，這一點非常重要，一種未被許多人充分認識的疾病，但這種疾病會產生非常嚴重的後果，正如我所說，是美國女性進行肝臟移植的首要原因，驚人的統計數據。

We believe that patients have to be educated and we believe by activating the patients that are already diagnosed and let me be crystal clear on that. Our efforts are going to be directed towards the 315,000 patients that are already diagnosed having them educated and activated will be important for the I'd say, the field to better be able to treat NASH and for patients to be able to get access to Rezdiffra.

我們認為必須對患者進行教育，我們相信透過啟動已經確診的患者，讓我清楚地說明這一點。我們的努力將針對已確診的 315,000 名患者，讓他們接受教育並激活他們，這對於這個領域能夠更好地治療 NASH 以及讓患者能夠獲得 Rezdiffra 非常重要。

So those efforts are kind of ongoing, but they're really starting in the near future. And we expect those to be helpful and certainly provide a source for patients to learn more about the disease and learn more about the product.

因此，這些努力仍在進行中，但它們實際上在不久的將來才開始。我們希望這些內容能夠有所幫助，並且肯定會為患者提供更多有關疾病和產品的資訊來源。

Thanks, Jay. Malala, next question, please.

謝謝，傑伊。馬拉拉，請下一個問題。

Prakhar Agarwal, Cantor.

普拉哈·阿加瓦爾，康托爾。

Hi, good morning and congrats on the quarter and the launch. I just want to what are you hearing on what payers and physicians will require to track response for Rezdiffra for 12 months and beyond for reauthorization? Specifically will stable patients on Rezdiffra will be reauthorized or only patients who show some improvement on noninvasive? Thank you.

你好，早安，恭喜本季和發布。我只是想知道您聽說付款人和醫生需要什麼來追蹤 Rezdiffra 的反應 12 個月及更長的時間才能重新授權？具體來說，使用 Rezdiffra 治療的病情穩定的患者是否會重新獲得授權，還是僅對非侵入性治療顯示出一些改善的患者進行授權？謝謝。

Yeah, Prakhar. Thank you very much for the question. Yeah, we are hearing that if there are kind of a reauthorization period at around 12 months and that's typical for a specialty products, you have a reauthorization at that point. It varies, but as you said, it's either stabilization or improvement. We're still 9 months away from the first patient actually going through that or so 10 months to 8 months, whatever it is in that range.

是的，普拉哈爾。非常感謝你的提問。是的，我們聽說，如果有 12 個月左右的重新授權期（這對於特殊產品來說是典型的情況），那麼您在那時就可以重新授權。它有所不同，但正如你所說，要么是穩定，要么是改善。距離第一個患者真正經歷大約 10 個月到 8 個月（無論這個範圍是多少），我們還有 9 個月的時間。

And that's something the policies are where they are today as well. We think that they're reasonable. But if there's any that aren't we have between now and that period of time to continue to talk to the payers about them. What we're seeing, for instance, with the expert recommendations that recently came out in clinical, gastroenterology and hepatology, they talked about kind of three stages.

今天的政策也是如此。我們認為他們是有道理的。但如果有任何問題，我們從現在到那段時間都可以繼續與付款人討論。例如，我們所看到的，最近在臨床、胃腸病學和肝病學領域提出的專家建議，他們談到了三個階段。

They talked about identifying a patient taking a look in after several months as to measure what's happening with the patient. And then at 12 months looking at efficacy and we think that's right. We think that a 12 month look at adequate efficacy is the right time because you have to remember with fibrosis and the FDA said this in their press release as well that we have seen an effect that we did at 52 weeks was really early they thought because fibrosis is such a significant hurdle to overcome.

他們談到要確定幾個月後進行檢查的患者，以衡量患者的情況。然後在 12 個月時觀察療效，我們認為這是正確的。我們認為12 個月觀察足夠的療效是正確的時間，因為你必須記住纖維化，FDA 在他們的新聞稿中也說過這一點，我們已經看到了我們在52 週時所做的效果非常早，他們認為因為纖維化是一個需要克服的重大障礙。

So we think that we're very comfortable right now with what the policies say and we're comfortable with the expert recommendations that have been put forth as well.

因此，我們認為我們現在對政策的內容非常滿意，並且對專家提出的建議也很滿意。

Thanks for the question. It's 8:45, we're at the mark. So, we have time for one more question, Malala

謝謝你的提問。現在是 8 點 45 分，我們到了目標。那麼，我們還有時間再問一個問題，馬拉拉

Jonathan Wolleben, Citizens JMP.

喬納森·沃萊本 (Jonathan Wolleben)，公民 JMP。

Hey, thanks for squeezing me in on. Just one. Bill, you mentioned kind of the peak sales a couple of times in your prepared remarks. Wondering how you're thinking internally with the peak opportunity as far as defer especially now when you're thinking about full economics of the Europe?

嘿，謝謝你讓我進來。只有一個。比爾，您在準備好的發言中多次提到了銷售高峰。想知道您在內部如何考慮推遲的高峰機會，尤其是現在當您考慮歐洲的整體經濟時？

Jon, it's a great question. Thanks for calling me out on that. I'm not going to tell you what we think peak is right now. Other than know, look, I think you look at the market dynamics. We said just US alone, there's about 315,000 patients.

喬恩，這是一個很好的問題。謝謝你叫我出來解決這個問題。我不會告訴你我們現在認為的峰值是什麼。除了知道之外，看看，我想你看看市場動態。我們說光是美國就有大約 315,000 名患者。

And any way you start to look at where this ends up penetrating to and it's a specialty category as this becomes a specialty light category I mean, NASH, overall, we're talking about billions and as the product that has a durable profile. When we look at any information that's presented at EASL, we don't think anyone is even as good as us and none of them are pills.

無論如何，你開始看看它最終會滲透到哪裡，它是一個專業類別，因為它成為一個專業輕型類別，我的意思是，NASH，總的來說，我們正在談論數十億，並且作為具有耐用外形的產品。當我們查看 EASL 上提供的任何資訊時，我們認為沒有人比我們更好，而且它們都不是藥丸。

And I'll tell you, you ask patients, especially these patients, they have a lot of other stuff that they have to take. [Uphill] is a lot easier and then you're going to add another injectable to my regimen and some of them don't make it feel that great either, and you still got to stay on something for a long time. Now we're still working on what the total opportunity is from a EU perspective and clearly from an F4 perspective that I open things up.

我會告訴你，你問病人，特別是這些病人，他們還有很多其他的東西必須服用。 [上坡]要容易得多，然後你要在我的治療方案中添加另一種注射劑，其中一些注射劑也不會讓人感覺那麼好，而且你仍然需要堅持很長一段時間。現在我們仍在研究從歐盟的角度以及我開放的 F4 的角度來看總體機會是什麼。

So I know that's a lot of talking without giving you the number that you want. But look, I think any way you look at it, this is a big as a specialty category, and we think that we are in the lead position. Now we think that we will be in the lead position for a long time because of not only the product profile, but the comprehensive data set that we've generated and we're continuing to generate. We are going to be a long way ahead of anyone who's even next to us.

所以我知道說了很多卻沒有給你想要的號碼。但是，我認為無論從哪個角度來看，這都是一個很大的專業類別，我們認為我們處於領先地位。現在，我們認為我們將在很長一段時間內處於領先地位，這不僅是因為產品概況，還因為我們已經產生並正在繼續生成的綜合資料集。我們將遠遠領先於我們旁邊的任何人。

Great, thanks, Jon. And thank you all for your time today and your interest. This now concludes our call. A replay of this webcast will be available on our website in about two hours. Thank you so much for joining us.

太好了，謝謝，喬恩。感謝大家今天抽出寶貴的時間和興趣。我們的通話到此結束。這個網路廣播的重播將在大約兩個小時後在我們的網站上提供。非常感謝您加入我們。

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

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