Atea Pharmaceuticals Inc (AVIR) 2024 Q2 法說會逐字稿

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals second quarter 2024 financial results and business update conference call. (Operator Instructions).

大家下午好，歡迎參加 Atea Pharmaceuticals 2024 年第二季財務業績和業務更新電話會議。（操作員說明）。

I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

我現在想將電話轉給 Atea Pharmaceuticals 投資者關係和企業傳播部高級副總裁 Jonae Barnes。巴恩斯女士，請繼續。

Thank you. And good afternoon, everyone. And welcome to Atea Pharmaceutical's second quarter 2024 financial results and business update conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our website at ir.ateapharma.com.

謝謝。大家下午好。歡迎參加 Atea Pharmaceutical 2024 年第二季財務業績和業務更新電話會議。今天早些時候，我們發布了一份新聞稿，概述了我們計劃討論的主題。您可以造訪我們網站 ir.ateapharma.com 的投資者部分，查看我們今天將要審查的新聞稿以及投影片。

With me today from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Dr. Arantxa Horga, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammond; Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran; and our Chief Commercial Officer, John Vavricka. They will all be available for the Q&A portion of today's call.

今天與我一起來自 Atea 的是我們的執行長兼創辦人 Jean-Pierre Sommadossi 博士； Arantxa Horga 博士，首席醫療官、首席開發官、Janet Hammond 博士；財務長兼法律執行副總裁 Andrea Corcoran；以及我們的首席商務官 John Vavricka。他們都將參加今天電話會議的問答部分。

Before we begin the call, and as outlined on slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties. These risk and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call.

在我們開始電話會議之前，正如投影片 2 所述，我想提醒您，今天的討論將包含涉及風險和不確定性的前瞻性陳述。這些風險和不確定性在今天的新聞稿和公司最近向美國證券交易委員會提交的文件中進行了概述，我們鼓勵您閱讀這些文件。我們的實際結果可能與今天電話會議中討論的內容有重大差異。

With that, I'll now turn the call over to Jean-Pierre.

現在，我將把電話轉給讓-皮埃爾。

Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. The first half of 2024 was marked by strong operational execution and significant clinical progress. We completed patient enrollment in both the global Phase 3 SUNRISE-3 study of bemnifosbuvir for the treatment of COVID-19 and the global Phase 2 study evaluating the combination of bemnifosbuvir and ruzasvir in treatment-naive HCV infected patients.

謝謝你，喬奈。大家下午好，感謝您加入我們。2024 年上半年的特點是強勁的營運執行力和重大的臨床進展。我們完成了貝尼福布韋治療 COVID-19 的全球 3 期 SUNRISE-3 研究和評估貝尼福布韋和魯扎斯韋聯合治療初治 HCV 感染患者的全球 2 期研究的患者入組。

As you know, COVID is now endemic and, as new variants continue to evolve, they are likely to continue to cause the recurrent surges of cases. Following the winter surge of infections caused by the variant JN.1, we are now experiencing a summer wave across the US, Europe and global location largely driven by new KP and LB.1 variants.

如您所知，新冠病毒現在已呈現地方性流行，隨著新變種的不斷演變，它們可能會繼續導致病例反覆激增。繼 JN.1 變種引起的冬季感染激增之後，我們現在正在美國、歐洲和全球各地經歷夏季感染浪潮，這主要是由新的 KP 和 LB.1 變種推動的。

There is a continued unmet need for suitable therapies leaving the most vulnerable people at risk for severe outcomes from infection such as the elderly, immunocompromised and those with underlying risk factors. We look forward to potentially delivering bemnifosbuvir to millions of patients and we expect to report results from SUNRISE-3 in the second half of 2024.

對合適療法的需求持續未被滿足，使最脆弱的族群面臨感染嚴重後果的風險，例如老年人、免疫功能低下和有潛在危險因子的人。我們期待著向數百萬患者提供 bemnifosbuvir，並預計在 2024 年下半年報告 SUNRISE-3 的結果。

Turning now to our Phase 2 for HCV. In June, at EASL, we showcased a potential best-in-class profile of bemnifosbuvir and ruzasvir and the promise of this combination to address the unmet needs of today HCV patients.

現在轉向 HCV 的第二階段。6 月，在 EASL 上，我們展示了 bemnifosbuvir 和 Ruzasvir 的潛在同類最佳概況，以及該組合有望解決當今 HCV 患者未滿足的需求。

The demographic of HCV patients has changed over time. Today, patients take multiple concomitant medication and those at the highest risk for HCV are also likely to be poorly adherent with their medications. We believe that our combination with the low risk of drug-drug interactions, combined with a short treatment duration, has the potential to address these unmet needs. We look forward to reporting the full results of the ongoing Phase 2 study during the fourth quarter of this year.

HCV 患者的人口統計會隨著時間的推移而改變。現今，患者同時服用多種藥物，而C肝病毒感染風險最高的患者也可能難以堅持用藥。我們相信，我們的藥物與藥物交互作用的風險低，再加上治療時間短，有可能解決這些未滿足的需求。我們期待在今年第四季報告正在進行的第二階段研究的全部結果。

We are currently preparing for the initiation of the Phase 3 program. I am pleased to report today that we have selected a fixed dose combination tablet that achieves comparable drug exposure to individually administered bemnifosbuvir and ruzasvir. This new tablet allows us to decrease the daily pill burden from four tablets to two, which is more convenient obviously for the patient.

我們目前正在準備啟動第三階段計劃。我今天很高興地向大家報告，我們選擇了一種固定劑量組合片劑，其藥物暴露量與單獨給藥的貝尼福布韋和魯扎韋相當。這種新藥片使我們能夠將每天的服藥負擔從四片減少到兩片，這對患者來說顯然更方便。

This new tablet will be used in the Phase 3, program as well as for subsequent commitments, and I will answer will review the data in detail for you. Lastly, with $502 million of cash, cash equivalent and marketable securities at June 30, we are in a strong financial position to execute our strategy and we anticipate our runway will extend in 2027.

這款新平板電腦將用於第三階段計劃以及後續承諾，我將回答將為您詳細審查數據。最後，截至 6 月 30 日，我們擁有 5.02 億美元的現金、現金等價物和有價證券，我們擁有強大的財務狀況來執行我們的策略，我們預計我們的跑道將在 2027 年延長。

With that, I will now turn the call over to Arantxa for an update on our global Phase 2 HCV program.

現在，我將把電話轉給 Arantxa，了解我們全球 2 期 HCV 計畫的最新情況。

Thank you, Jean-Pierre. Let's now review our HCV program and recent highlights. Turning to slide 5, HCV continues to be a recognized healthcare crisis in the US with between 2 million to 4 million people living with HCV and new challenges continue to hinder progress toward eliminating it globally.

謝謝你，讓-皮埃爾。現在讓我們回顧一下我們的 HCV 計劃和最近的亮點。轉向幻燈片 5，HCV 仍然是美國公認的醫療危機，有 200 萬至 400 萬 HCV 感染者，新的挑戰繼續阻礙全球消除 HCV 的進展。

With the incidence of new infections annually outpacing the rate of those being treated with direct acting antivirals, it is clear that there are still unmet medical needs. Moving to slide 6, the US HCV treatment demand grew roughly 5% in 2023 based on the number of patients treated. The share of the two key treatment options, Epclusa and Mavyret, remains stable.

由於每年新感染的發生率超過了接受直接抗病毒藥物治療的感染率，顯然仍存在未滿足的醫療需求。轉到投影片 6，根據治療的患者數量，2023 年美國 HCV 治療需求增加約 5%。兩種關鍵治療方案 Epclusa 和 Mavyret 的份額保持穩定。

Given the current limitations and prescription trends, we believe a best-in-class profile together with anticipated future government initiatives and improved patient access will increase the number of patients treated. We believe that the profile of bemnifosbuvir and ruzasvir has the potential to drive the future standard of care.

考慮到當前的限制和處方趨勢，我們相信一流的概況以及預期的未來政府舉措和改善的患者可及性將增加接受治療的患者數量。我們相信，貝尼福布韋和魯札斯韋的概況有可能推動未來的照護標準。

Moving to slide 7, the profile of the patient has changed since the introduction of direct acting antivirals. Today, most US infected patients are younger in age and infections are highest among the age group between 30 to 39 years old. They are recently infected and less than 10% are cirrhotic.

轉到幻燈片 7，自從引入直接作用抗病毒藥物以來，患者的情況發生了變化。如今，美國大多數感染者的年齡都比較年輕，30 至 39 歲年齡層的感染率最高。他們最近被感染，不到 10% 患有肝硬化。

A high proportion of the current patients take multiple concomitant medications including HIV medications, antipsychotics, statins, proton pump inhibitors, and in addition, populations at the highest risk for HCV are frequently poorly adherent to their medication due to substance abuse disorders, including opioid use or other drugs and mental health disorders.

目前很大一部分患者同時服用多種藥物，包括HIV 藥物、抗精神病藥物、他汀類藥物、質子幫浦抑制劑，此外，HCV 風險最高的人群往往由於藥物濫用障礙（包括鴉片類藥物的使用）而對藥物依從性較差或其他藥物和精神健康障礙。

For this patient profile, a direct acting antiviral with low risk of drug-drug interactions combined with short treatment duration and no food effect would address these unmet needs and treat more patients successfully.

對於這種患者情況，藥物間交互作用風險低、治療持續時間短且無食物影響的直接作用抗病毒藥物將解決這些未滿足的需求，並成功治療更多患者。

Slide 8 reviews our potential best-in-class regimen which combines the most compelling attributes of current HCV drug treatments. It is protease inhibitor free with a short eight-week treatment duration. Our combination also has a low risk of drug-drug interactions and there is no food effect.

第 8 張投影片回顧了我們潛在的最佳治療方案，該治療方案結合了目前 HCV 藥物治療最引人注目的特性。它不含蛋白酶抑制劑，治療持續時間短為八週。我們的組合還具有較低的藥物交互作用風險，並且沒有食物效應。

Slide 9 reviews the data for the selected fixed dose combination tablet of bemnifosbuvir and ruzasvir that we will be using in our Phase 3 program and for subsequent commercialization. This new tablet allows us to decrease the daily pill count from four tablets to two which is more convenient for the patient. As you can see from the two graphs, the fixed dose combination drug exposure is comparable to individually administered bemnifosbuvir and ruzasvir. In addition, there is no food effect.

投影片 9 回顧了我們將在 3 期項目和後續商業化中使用的所選貝尼福布韋和魯扎韋固定劑量組合片劑的數據。這種新藥片使我們能夠將每日藥片數量從四片減少到兩片，這對患者來說更方便。從兩張圖可以看出，固定劑量組合藥物暴露量與單獨給藥的貝尼福布韋和魯札韋相當。此外，沒有食物效應。

In slide 10, we outlined our Phase 2 single-arm open label study of 550 milligrams of bemnifosbuvir in combination with 180 milligrams of ruzasvir once daily for eight weeks. I will discuss the results shortly. In this Phase 2 trial, which is currently ongoing, we involve 275 treatment-naive patients including the leading cohort of 60 patients. The primary endpoint of the study is SVR at week 12 post treatment and safety.

在幻燈片 10 中，我們概述了 550 毫克貝尼福布韋 (bemnifosbuvir) 聯合 180 毫克魯扎韋 (ruzasvir) 的 2 期單臂開放標籤研究，每天一次，持續八週。我將很快討論結果。在目前正在進行的這項 2 期試驗中，我們涉及 275 名未接受過治療的患者，其中包括 60 名主要患者。研究的主要終點是治療後第 12 週的 SVR 和安全性。

Moving to slide 11, as a reminder, the leading cohort of 60 patients were comprised of non-cirrhotic patients only. However, 10 patients had an advanced stage of fibrosis F3 which is borderline with cirrhosis. This slide shows the untreated viral kinetics of individual patient data from the leading cohort. As you can see, there was a rapid reduction of viral load in all patients within the first week, regardless of baseline viremia and genotypes.

轉到投影片 11，提醒一下，領先的 60 名患者群組僅由非肝硬化患者組成。然而，有 10 名患者患有晚期纖維化 F3，接近肝硬化。這張投影片顯示了來自主要隊列的個別患者數據的未經治療的病毒動力學。正如您所看到的，無論基線病毒血症和基因型如何，所有患者的病毒量在第一週內都迅速減少。

By week four on treatment, all 60 patients in the leading cohort had a viral load near or below the lower limit of quantification, and the virus was undetectable. Therefore, these very rapid kinetics across all genotypes support an eight-week regimen and compare favorably to Mavyret, which is the only approved eight-week treatment for HCV.

到治療第四週時，主要隊列中的所有 60 名患者的病毒量都接近或低於定量下限，且無法檢測到病毒。因此，所有基因型的這些非常快速的動力學支持八週治療方案，並且與 Mavyret 相比更有利，後者是唯一被批准的 HCV 八週治療方案。

Turning to slide 12, in June, we presented data at EASL from the leading cohort of 60 patients. We are pleased with the results, which showed a high SVR-12 rate of 97% with a short eight-week duration treatment. Importantly, the only two patients with post-treatment relapse or failure demonstrate the challenge of drug adherence in this patient population, which I'm going to review in further detail.

轉向幻燈片 12，6 月份，我們在 EASL 上展示了來自 60 名患者的主要隊列的數據。我們對結果感到滿意，結果顯示，在短短八週的治療時間內，SVR-12 的成功率高達 97%。重要的是，僅有兩名治療後復發或失敗的患者證明了該患者群體中藥物依從性的挑戰，我將對此進行更詳細的審查。

On slide 13, results from the leading cohort also show a SVR-12 rate of 100% in all 13 patients infected with genotype 3, a historically difficult-to-treat genotype of HCV. Data also showed a 98% SVR-12 rate in 43 out of 44 patients with genotype 1.

在投影片 13 上，主要隊列的結果也顯示，所有 13 名感染基因型 3 的患者的 SVR-12 率為 100%，基因型 3 是一種歷史上難以治療的 HCV 基因型。數據也顯示，44 名基因型 1 患者中，有 43 名患者的 SVR-12 率為 98%。

Turning to slide 14, as mentioned earlier, two subjects that were genotype 1b and genotype 2b experienced post-treatment relapse in the leading cohort. This slide shows the viral kinetics, plasma drug levels, and resistance sequencing data of the genotype 1b patient.

轉向幻燈片 14，如前所述，領先隊列中基因型 1b 和基因型 2b 的兩名受試者經歷了治療後復發。這張幻燈片顯示了基因型 1b 患者的病毒動力學、血漿藥物水平和抗藥性定序數據。

The viral relapse or failure was due to treatment non-adherence and not due to viral resistance, as indicated by the lack of new mutations. This was demonstrated by low plasma and inadequate drug levels at week-six and week-eight, and similar viral mutations at baseline and 12-weeks post-treatment.

病毒復發或失敗是由於不堅持治療，而不是由於病毒抗藥性，如缺乏新突變所示。第六週和第八週時的低血漿和藥物水平不足以及基線和治療後 12 週時的類似病毒突變證明了這一點。

And on slide 15, we see the viral kinetics, plasma drug levels, and resistance sequencing data of the genotype 2b patient. Once again, low plasma and inadequate drug levels at week-six and week-eight, combined with similar viral mutations at baseline and 12-weeks post-treatment. The lack of new mutations indicate that the observed relapse or failure was due to treatment non-adherence rather than viral failure due to resistance. These data further outline the challenge of drug adherence in the current patient population and reinforce the need for short treatment duration and convenience therapy.

在投影片 15 上，我們看到了基因型 2b 患者的病毒動力學、血漿藥物濃度和抗藥性定序數據。第六週和第八週再次出現低血漿和藥物濃度不足，加上基線和治療後 12 週時類似的病毒突變。缺乏新突變表明觀察到的復發或失敗是由於不堅持治療而不是由於抗藥性導致的病毒失敗。這些數據進一步概述了目前患者群體中藥物依從性的挑戰，並強化了對短治療持續時間和便利治療的需求。

On slide 16, we see yet another example showing that poor drug adherence in this population remains a challenge. However, in these two patients that were poorly adherent, the high potency of our combination still led to a positive outcome of achieving SVR-12 or cure.

在投影片 16 上，我們看到另一個例子，顯示該族群的藥物依從性差仍然是一個挑戰。然而，在這兩名依從性較差的患者中，我們的組合的高效力仍然帶來了實現 SVR-12 或治癒的積極結果。

On the next slide. Slide 17, the combination of bemnifosbuvir and ruzasvir was generally safe and well tolerated in the leading cohort. There were no drug-related serious adverse events, no discontinuations, and adverse events were mostly mild.

在下一張投影片上。在幻燈片 17 中，貝尼福布韋 (bemnifosbuvir) 和魯扎斯韋 (ruzasvir) 的組合在領先隊列中總體上是安全的且耐受性良好。沒有與藥物相關的嚴重不良事件，沒有停藥，不良事件大多是輕微的。

Turning to slide 18, to summarize our HCV efforts, in June, we completed enrollment of 275 patients. The study is ongoing, and we expect to report complete SVR-12 results in the fourth quarter of this year.

轉向投影片 18，總結我們的 HCV 工作，6 月份，我們完成了 275 名患者的入組。該研究正在進行中，我們預計將在今年第四季報告完整的 SVR-12 結果。

We have selected the fixed dose combination tablet, which will be used in the Phase 3 program and for subsequent commercialization. We are on track with activities to initiate the Phase 3 program around the end of this year, and pending discussions with regulatory agencies, we expect to conduct two studies with at least one having an active comparator.

我們選擇了固定劑量組合片劑，將用於3期專案以及後續的商業化。我們正按計劃在今年年底左右啟動第三階段計劃，並在與監管機構討論之前，我們預計將進行兩項研究，其中至少一項具有活躍的比較器。

We are excited about the significant progress and the positive results we have achieved for the HCV program, and look forward to providing more updates throughout the rest of this year.

我們對 HCV 計劃的重大進展和積極成果感到興奮，並期待在今年剩餘時間內提供更多更新。

And with that, I will now turn the call over to Janet to discuss our COVID-19 and the global Phase 3 SUNRISE-3 trials.

現在，我將把電話轉給 Janet，討論我們的 COVID-19 和全球 3 期 SUNRISE-3 試驗。

Thanks, Arantxa. Good afternoon, everyone. Turning to slide 20, COVID-19 continues to evolve, and as Jean-Pierre mentioned earlier, we're now experiencing a summer wave across the US, Europe, and other global locations, which is largely being driven by the new KP and LB.1 variants.

謝謝，阿蘭特薩。大家下午好。轉向幻燈片 20，COVID-19 繼續發展，正如 Jean-Pierre 之前提到的，我們現在正在美國、歐洲和全球其他地區經歷夏季浪潮，這在很大程度上是由新的 KP 和 LB 推動的. 1 變型。

Viral wastewater modeling suggests the current US COVID wave currently is around 900,000 new daily infections. High risk populations, such as the elderly, those who are immunocompromised, and those with underlying risk factors, are more likely to become severely ill with COVID-19. There's a continuing unmet medical need, and our goal for COVID-19 is to deliver a safe and effective treatment that addresses the key limitations of current available therapies.

病毒廢水模型表明，目前美國新冠疫情浪潮中每日新增感染病例約為 90 萬例。高風險族群，例如老年人、免疫功能低下者和具有潛在危險因子的人，更有可能因感染 COVID-19 而病情嚴重。醫療需求持續未被滿足，我們針對 COVID-19 的目標是提供安全有效的治療方法，以解決目前可用療法的主要限制。

Slide 21, bemnifosbuvir has a robust target profile with a low risk for drug-drug interactions, favorable safety and tolerability, and a distinct mechanism of action with a high barrier to treatment resistance.

在幻燈片 21 中，bemnifosbuvir 具有強大的標靶特徵，藥物間相互作用的風險較低，具有良好的安全性和耐受性，並且具有獨特的作用機制，具有較高的治療抗藥性。

We've completed several studies evaluating bemnifosbuvir for COVID-19. In the MORNINGSKY trial in outpatients, the risk of hospitalization was 71% lower for bemnifosbuvir versus placebo and 82% in patients over the age of 40-years. In addition, in a Phase 2 study in hospitalized patients, there were no deaths in patients administered bemnifosbuvir in comparison with three deaths in the placebo group.

我們已經完成了多項評估貝尼福布韋 (bemnifosbuvir) 對 COVID-19 的研究。在 MORNINGSKY 門診試驗中，與安慰劑相比，貝尼福布韋的住院風險降低了 71%，而 40 歲以上患者的住院風險降低了 82%。此外，在住院患者的一項 2 期研究中，服用貝尼福布韋的患者沒有死亡，而安慰劑組有 3 例死亡。

Moving to slide 22. The global Phase 3 SUNRISE-3 trial in hospital enrolled only high-risk outpatients with mild or moderate COVID-19, regardless of their vaccination status. Symptom onset was five or less days before randomization.

轉到投影片 22。全球 3 期 SUNRISE-3 醫院試驗僅招募輕度或中度 COVID-19 的高風險門診患者，無論其疫苗接種狀況如何。症狀出現時間為隨機分組前五天或更短時間。

This Phase 3 study was randomized, double-blinded and placebo controlled. The study drug, either bemnifosbuvir 550 mg twice a day or placebo, was administered concurrently with the locally available standard of care, including other compatible COVID-19 antiviral drugs at the discretion of the investigator. The primary endpoint of the study is all-cause hospitalization or death through day 29 in the supportive care monotherapy population.

這項 3 期研究是隨機、雙盲和安慰劑對照的。研究藥物為 bemnifosbuvir 550 mg 每天兩次或安慰劑，與當地可用的護理標準同時給藥，包括研究者自行決定的其他相容的 COVID-19 抗病毒藥物。研究的主要終點是支持性護理單一療法族群截至第 29 天的全因住院或死亡。

Turning to slide 23, in summary, we enrolled 2,221 patients in the monotherapy cohort and only 74 patients in the combination cohort. The high rate of enrollment in the monotherapy cohort shows a clear preference by investigators for a new therapy and highlights the major unmet medical need for new oral COVID-19 treatment options for these high-risk patients. We look forward to providing the results from our Phase 3 trial during the second half of 2024.

轉向幻燈片 23，總而言之，我們在單一療法隊列中招募了 2,221 名患者，而在聯合療法隊列中僅招募了 74 名患者。單藥治療組的高入組率表明研究人員對新療法的明顯偏好，並突顯了這些高風險患者對新的口服 COVID-19 治療方案的主要未滿足的醫療需求。我們期待在 2024 年下半年提供 3 期試驗的結果。

I'll now turn the call over to John to discuss the COVID-19 market opportunity.

我現在將電話轉給 John，討論 COVID-19 市場機會。

Thanks, Janet. Moving to slide 24, the US prescription demand for oral antivirals to treat COVID-19 highly correlates with the infection rate. Of note, there was an increase of 32% in COVID-19 oral antiviral prescriptions for June 2024 versus June 2023, correlating with the early summer wave related to the KP and LB.1 variants.

謝謝，珍妮特。轉到幻燈片 24，美國治療 COVID-19 的口服抗病毒藥物的處方需求與感染率高度相關。值得注意的是，與 2023 年 6 月相比，2024 年 6 月的 COVID-19 口服抗病毒處方增加了 32%，這與 KP 和 LB.1 變異體相關的初夏浪潮相關。

We are confident the market opportunity for oral antiviral therapeutics for COVID-19 will continue to remain a multi-billion dollar opportunity for the long run. This is supported by IQVIA's retail prescription data indicating between $4 billion and $5 billion of annual revenues between the two currently available oral antiviral products.

我們相信，從長遠來看，COVID-19 口服抗病毒療法的市場機會將繼續保持數十億美元的機會。IQVIA 的零售處方數據證明了這一點，該數據表明目前兩種口服抗病毒產品的年收入在 40 億至 50 億美元之間。

Between feedback from patients and physicians and the available data, it's clear there is a significant unmet need for an antiviral treatment option that addresses the limitations related to drug-drug interactions and tolerability with Paxlovid and safety concerns with Lagevrio. We believe in bemnifosbuvir and its potential to meaningfully improve the COVID-19 treatment paradigm and bring tremendous value to patients and physicians.

從患者和醫生的反饋以及現有數據來看，很明顯，抗病毒治療方案的需求尚未得到滿足，這種治療方案可以解決與Paxlovid 藥物相互作用和耐受性相關的局限性以及Lagevrio 的安全性問題。我們相信 bemnifosbuvir 及其有效改善 COVID-19 治療模式並為患者和醫生帶來巨大價值的潛力。

I'll now turn the call over to Andrea to discuss Atea's financials.

我現在將電話轉給 Andrea，討論 Atea 的財務狀況。

Thank you, John. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the second quarter of 2024. The statement of operations and balance sheet can be found on slides 26 and 27.

謝謝你，約翰。正如 Jonae 在今天早些時候的介紹性發言中提到的，我們發布了一份新聞稿，其中包含 2024 年第二季度的財務業績。營運報表和資產負債表可在投影片 26 和 27 中找到。

As you'll note, in the second quarter of 2024, there was a marked increase in research and development expenses compared to the prior-year period. This increase was related to the advancement and subsequent completion of patient involvement for both our Phase 3 SUNRISE-3 COVID-19 clinical trial and our Phase 2 HCV trial.

正如您將注意到的，2024 年第二季度，研發費用與去年同期相比顯著增加。這一增長與我們的 3 期 SUNRISE-3 COVID-19 臨床試驗和 2 期 HCV 試驗的進展和隨後完成的患者參與有關。

For general and administrative expenses, there was a decrease in the quarter compared to the corresponding period in 2023. This decrease was attributable to incurring lower professional fees in the second quarter of 2024. Interest income in the second quarter of 2024 decreased compared to the second quarter of 2023 due to lower investment balances.

對於一般和管理費用，該季度與 2023 年同期相比有所下降。這一下降是由於 2024 年第二季專業費用降低。由於投資餘額減少，2024 年第二季的利息收入較 2023 年第二季有所下降。

During the remainder of 2024, we expect our R&D spend to vary as our SUNRISE-3 and our HCV studies complete and further activities to initiate the HCV program in the fourth quarter of the year. As Jean-Pierre mentioned, at the end of the second quarter of 2024, our cash, cash equivalent and marketable securities balance was $502.2 million. Maintaining our strong financial discipline, strategically focused investment, we project our cash guidance runway into 2027.

在 2024 年剩餘時間內，隨著 SUNRISE-3 和 HCV 研究的完成以及在今年第四季度啟動 HCV 計畫的進一步活動，我們預計我們的研發支出將會有所變化。正如 Jean-Pierre 所提到的，截至 2024 年第二季末，我們的現金、現金等價物和有價證券餘額為 5.022 億美元。保持嚴格的財務紀律和策略重點投資，我們預計現金指導跑道將持續到 2027 年。

I'll now hand the call back to Jean-Pierre for closing remarks.

現在，我將把電話轉回給讓-皮埃爾，讓他作結束語。

So in closing on slide 29, I'm very pleased with the significant clinical progress we have made this year across both programs. The multiple key milestones for both programs expected throughout the remainder of 2024 have the potential to drive significant shareholder value and positions Atea for an exciting rest of the year.

在投影片 29 的最後，我對今年我們在這兩個計畫上取得的重大臨床進展感到非常滿意。預計在 2024 年剩餘時間內，這兩個項目將實現多個關鍵里程碑，有可能推動顯著的股東價值，並使 Atea 在今年剩餘時間內度過令人興奮的時光。

For our COVID-19 program, we expect to report top line results from SUNRISE-3 in the second half of 2024 and we are targeting the NDA submission around the year end. Additionally, we continue to also make progress with our early-stage discovery program focused on the highly differentiated second generation protease inhibitors and we will provide an update later this year.

對於我們的 COVID-19 計劃，我們預計在 2024 年下半年報告 SUNRISE-3 的主要結果，並計劃在年底左右提交 NDA。此外，我們專注於高度差異化的第二代蛋白酶抑制劑的早期發現計劃也繼續取得進展，我們將在今年稍後提供更新。

For HCV, the data presented at EASL demonstrate a potential best-in-class profile that combines, as Arantxa mentioned, the most compelling attributes of current HCV drug treatment through the innovative combination of bemnifosbuvir and ruzasvir. And we look forward to reporting the full results in 275 patients for our Phase 2 study during the fourth quarter of this year.

對於 HCV，EASL 上提供的數據展示了潛在的同類最佳概況，正如 Arantxa 所提到的，透過貝尼福布韋和魯扎韋的創新組合，結合了當前 HCV 藥物治療最引人注目的屬性。我們期待在今年第四季報告 275 名患者的 2 期研究的完整結果。

As a relatively small organization, I'd like to remind, with fewer than 80 employees, I'm extremely pleased with the effort and the achievement of the team, with successful execution on two global studies in multi-million dollar market opportunities and still being very financially responsible.

作為一個規模相對較小的組織，我想提醒一下，雖然員工數量不足80 名，但我對團隊的努力和成就感到非常滿意，成功執行了兩項涉及數百萬美元市場機會的全球研究，並且仍然非常有經濟責任感。

We believe that our product candidates are highly differentiated and have the opportunity, if approved, to address significant unmet medical needs in the current treatment landscape and both have strong blockbuster potential.

我們相信，我們的候選產品具有高度差異化，如果獲得批准，將有機會解決當前治療領域中未滿足的重大醫療需求，並且都具有強大的重磅炸彈潛力。

With that, I will now turn the call back over to the operator.

這樣，我現在將把電話轉回給接線生。

(Operator Instructions).

（操作員說明）。

Maxwell Skor, Morgan Stanley.

麥克斯韋‧斯科爾，摩根士丹利。

Great. Thank you for taking my questions. Can you just walk me through the payer dynamic for Hep C? What percent of chronic Hep C patients are on Medicaid? And are these patients prescribed generic Epclusa in general?

偉大的。感謝您回答我的問題。您能否向我介紹一下C型肝炎的付款人動態？接受醫療補助的慢性C肝患者的百分比是多少？這些患者通常會服用仿製藥 Epclusa 嗎？

John, you want to address the question?

約翰，你想回答這個問題嗎？

Sure. For Hep C, the government supported programs with Medicaid and Medicare, as you would expect, comprise the larger majority from the payer perspective and then followed up by commercial lives.

當然。對於丙型肝炎，如您所料，政府支持的醫療補助和醫療保險計劃從付款人的角度來看佔了絕大多數，然後是商業生活。

Your question as regards to -- from Epclusa, whether it's the brand or authorized copy, both of those, both the authorized copy and the brand, are still selling products and pretty much are dictated by the dynamics of the various payers. Some have their financial incentives driven off of the wholesale acquisition cost. Others look at just direct net discounts. But both of them do exist depending on the models that the individual payers have.

你的問題是關於 Epclusa 的問題，無論是品牌還是授權副本，授權副本和品牌都仍在銷售產品，並且很大程度上取決於各個付款人的動態。有些人的財務誘因來自於批發採購成本。其他人只關注直接淨折扣。但它們確實存在，具體取決於個人付款人的模型。

Just to add, Max, to John, we are talking about authorized copy, not generics. Actually, we all know – or maybe I can share, that the IP so far that is public, both for Mavyret and Epclusa, will go at least until 2036. So we don't anticipate the entry of so-called generics before 2036 for both approved drugs.

麥克斯，向約翰補充一下，我們談論的是授權副本，而不是仿製藥。事實上，我們都知道——或者也許我可以分享，Mavyret 和 Epclusa 迄今為止公開的智慧財產權將持續至少到 2036 年。因此，我們預計這兩種已批准藥物不會在 2036 年之前進入所謂的仿製藥。

Okay. Thank you.

好的。謝謝。

Jon Miller, Evercore.

喬恩‧米勒，《Evercore》。

Hi, guys. Thanks for taking the question. I recently noticed that Pfizer has a next-gen Paxlovid in development with no metallic taste, no ritonavir, higher potency at target, so a lot of the same things that we've been talking about bemnifosbuvir in the COVID space. I assume you've seen their paper, do you still expect to have a competitive edge versus that sort of a program? And what are your plans to commercialize in the space versus a major player like Pfizer?

嗨，大家好。感謝您提出問題。我最近注意到輝瑞正在開發下一代 Paxlovid，它沒有金屬味，沒有利托那韋，目標效力更高，所以與我們在新冠領域談論的貝尼福布韋有很多相同的事情。我假設您已經看過他們的論文，您是否仍然期望與此類程式相比具有競爭優勢？與輝瑞這樣的主要企業相比，你們在該領域的商業化計畫是什麼？

Janet, do you want to address the first part? And then John will do the commercial?

珍妮特，你想談談第一部分嗎？然後約翰會拍廣告嗎？

It is an interesting one. Obviously, they've got a long way to go. And we look forward to seeing how the program progresses. Certainly, we believe that having more than one mechanism of action available for patients is going to be important. I think particularly with the substantial uptake that there already is with Paxlovid, I know that it could be a lot higher when you look at the number of cases, but as John mentioned with the commercial uptake that we see, there is significant use of Paxlovid. (inaudible) use of protease inhibitors. There's a potential for the generation of resistance and this is much less likely with a nucleoside analog.

這是一件有趣的事。顯然，他們還有很長的路要走。我們期待看到該計劃的進展。當然，我們相信為患者提供不只一種作用機制將非常重要。我認為，尤其是Paxlovid 已經有了很大的應用，我知道當你看案例數量時，它可能會高得多，但正如約翰在我們看到的商業應用中提到的那樣，Paxlovid 的使用量很大。 （聽不清楚）使用蛋白酶抑制劑。有可能產生抗藥性，而核苷類似物則不太可能產生抗藥性。

So, we believe that there's certainly scope for both in the market case, and I think were there to be more agents, it would be of benefit to everybody. But we're confident of the profile that we've seen with our drug and we look forward to seeing more about that.

因此，我們相信，在市場案例中，兩者都有一定的發展空間，而且我認為，如果有更多的代理商，這將對每個人都有利。但我們對我們的藥物所看到的情況充滿信心，我們期待看到更多相關資訊。

From a commercial perspective, although we don't comment on partnering discussions, for the US, for our COVID-19 programs, we plan to co-promote with a pharmaceutical company and the criteria for them would have primary care and managed care capabilities and, of course, a commercial infrastructure. So from a competitive standpoint, we would feel very confident from a future partner standpoint.

從商業角度來看，雖然我們不對合作討論發表評論，但對於美國來說，對於我們的COVID-19項目，我們計劃與一家製藥公司共同推廣，他們的標準是擁有初級保健和管理式醫療能力，當然，還有商業基礎設施。因此，從競爭的角度來看，從未來合作夥伴的角度來看，我們會感到非常有信心。

Makes sense. Thanks.

有道理。謝謝。

And I'm showing no further questions at this time. I would now like to turn the call back to Jean-Pierre for closing remarks.

目前我不會再提出任何問題。現在我想將電話轉回給讓-皮埃爾，讓他致閉幕詞。

Thank you all for joining our second quarter of 2024 earnings conference call and thank you as well for your continued support.

感謝大家參加我們的 2024 年第二季財報電話會議，也感謝大家的持續支持。

This concludes today's conference call. Thank you all for participating. You may now disconnect.

今天的電話會議到此結束。感謝大家的參與。您現在可以斷開連線。