Atea Pharmaceuticals, Inc. (AVIR) 2026 Q2 法說會逐字稿

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals second quarter 2026 financial results and business update conference call. (Operator Instructions)

各位下午好，歡迎參加 Atea Pharmaceuticals 2026 年第二季財務業績與業務更新電話會議。(接線員指示)

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.

現在我想將電話交給 Atea Pharmaceuticals 投資人關係與企業傳播資深副總裁 Jonae Barnes。Barnes 女士，請開始。

Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' Second Quarter 2026 Financial Results and Business Update Conference Call. Earlier today, we issued a press release, which outlined 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 investor section of our website at ir.ateapharma.com. With me from Atea are our Chief Executive Officer and Founder, Dr.

謝謝，接線員。各位下午好，歡迎參加 Atea Pharmaceuticals 2026 年第二季財務業績與業務更新電話會議。今天稍早，我們發布了新聞稿，概述了我們計畫討論的主題。您可前往我們網站的投資人專區 ir.ateapharma.com 取得新聞稿以及我們今天將檢視的簡報投影片。與我一同出席的 Atea 團隊成員包括我們的執行長暨創辦人 Dr.

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

Jean-Pierre Sommadossi；開發長 Dr. Janet Hammond；商務長 John Vavricka；醫務長 Dr. Arantxa Horga；以及財務長兼法務執行副總裁 Andrea Corcoran，他們將在今天電話會議的問答環節提供回應。

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 risks and uncertainties. These risks 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.

在我們開始之前，並如投影片第 2 頁所示，我想提醒各位，今天的討論將包含前瞻性陳述，涉及風險與不確定性。這些風險與不確定性已在今日新聞稿以及公司近期向美國證券交易委員會提交的文件中說明，我們鼓勵各位閱讀。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.

接下來，我將把電話交給 Jean-Pierre。

Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on slide 3. The positive top-line results from C-BEYOND, our Phase 3 trial evaluating the combination of bemnifosvir and ruzasvir for the treatment of hepatitis C in North America, represent a significant milestone for Atea and for the millions of people living with hepatitis C who need a shorter, simpler path to cure. We were very pleased that C-BEYOND met both its primary and secondary endpoints, with BEM-ruzasvir demonstrating statistical non-inferiority to Epclusa, the current standard of care.

謝謝你，Jonae。各位下午好，感謝各位加入我們。我將從投影片第 3 頁開始。C-BEYOND 的正向主要結果（top-line results）—我們在北美進行的第 3 期試驗，用於評估 bemnifosvir 與 ruzasvir 聯合治療 C 型肝炎—對 Atea 以及數以百萬計需要更短、更簡單治癒途徑的 C 型肝炎患者而言，都是一項重要里程碑。我們非常高興 C-BEYOND 同時達成主要與次要終點，且 BEM-ruzasvir 相較於目前的標準治療 Epclusa 展現統計學上的非劣性。

Importantly, this was the first successful Phase 3 trial in a global head-to-head HCV program achieved in a real-world patient population that was polymedicated, psychiatrically complex, substance abuse affected, and adherence challenged. These results reinforce the need for a best-in-class profile designed for the broad and complex hepatitis C population clinicians treat today. Arantxa will review in detail the results of the trial.

重要的是，這是首個在真實世界患者族群中達成成功的全球 HCV 正面對照（head-to-head）第 3 期試驗；該族群具有多重用藥、精神疾病複雜、受物質濫用影響，以及用藥依從性具挑戰等特徵。這些結果強化了臨床醫師在今日所治療的廣泛且複雜 C 型肝炎族群中，對於具同級最佳（best-in-class）特性之治療方案的需求。Arantxa 將詳細回顧本試驗結果。

C-FORWARD, our second Phase 3 trial being conducted outside North America, is fully enrolled with more than 880 patients, and we remain on track to report top-line results in early Q1 2027. We believe that the C-FORWARD dataset will provide important confirmatory efficacy data across a broader range of genotypes and strengthen the pangenotypic regulatory package for BEM-ruzasvir.

C-FORWARD 是我們第二項在北美以外地區進行的第 3 期試驗，目前已完成收案，納入超過 880 名患者；我們仍按計畫於 2027 年第一季初公布主要結果（top-line results）。我們相信 C-FORWARD 的資料集將提供跨更廣泛基因型的重要確認性療效數據，並強化 BEM-ruzasvir 的泛基因型（pangenotypic）法規申請資料包。

In July, we also initiated our first-in-human Phase 1 clinical trial of AT-587, our potential first-in-class direct-acting antiviral for chronic hepatitis E, a serious disease with no approved therapy today. This milestone reflects the continued advancement of our all-direct-acting antiviral pipeline. We remain in a solid financial position with $219.5 million in cash and marketable securities as of June 30, 2026, with our cash runway anticipated through 2027.

此外，我們於 7 月啟動 AT-587 的首次人體（first-in-human）第 1 期臨床試驗；AT-587 是我們潛在同類首創（first-in-class）的直接作用型抗病毒藥物，用於治療慢性 E 型肝炎—這是一種嚴重疾病，目前尚無核准療法。此里程碑反映我們全直接作用型抗病毒（all-direct-acting antiviral）產品線的持續推進。截至 2026 年 6 月 30 日，我們持有 2.195 億美元的現金及有價證券，財務狀況仍然穩健，預期現金可支應至 2027 年。

I will now hand the call over to Arantxa, our Chief Medical Officer, to review our Phase 3 program.

接下來我將把電話交給我們的醫務長 Arantxa，請她回顧我們的第 3 期計畫。

Thank you, Jean-Pierre. Good afternoon, everyone. Moving to slide 5, C-BEYOND was a randomized active-control non-inferiority trial against sofosbuvir/velpatasvir, marketed as Epclusa, a standard of care regimen. The trial involved patients with chronic HCV at approximately 120 clinical sites in the US and Canada, including patients coinfected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received BEM-ruzasvir for eight weeks or SOF/VEL for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen.

謝謝你，Jean-Pierre。各位下午好。請看投影片第 5 頁，C-BEYOND 是一項隨機分派、以主動對照（active-control）進行的非劣性試驗，對照組為 sofosbuvir/velpatasvir（市售名 Epclusa），屬於標準治療方案。本試驗在美國與加拿大約 120 個臨床試驗中心納入慢性 HCV 患者，包括 HIV 共感染患者，以及涵蓋北美主要流行的 HCV 基因型患者。無肝硬化患者接受 BEM-ruzasvir 治療 8 週或 SOF/VEL 治療 12 週。代償性肝硬化患者則接受任一方案治療 12 週。

On slide 6, let's now review the C-BEYOND endpoints and patient populations. The primary efficacy endpoint is SVR or cure at week 24, assessing the modified intent-to-treat or MITT population, which was agreed upon with the FDA. This population includes all patients who received at least one dose of the regimen, including those who discontinued early, were not compliant, or were lost to follow-up. The trial is powered at 90% with a 5% non-inferiority margin. C-BEYOND is the anchor trial for the US NDA submission.

在投影片第 6 頁，我們來回顧 C-BEYOND 的終點與患者族群。主要療效終點為第 24 週的 SVR（持續病毒學反應）或治癒率，評估族群為經 FDA 同意的修正意向治療（modified intent-to-treat，MITT）族群。此族群包含所有至少接受一劑治療方案的患者，包括提前停藥、未遵從用藥、或失訪者。本試驗以 90% 的檢定力設計，非劣性界值為 5%。C-BEYOND 是美國 NDA 申請的關鍵樞紐（anchor）試驗。

Moving to slide 7, you can see that the baseline characteristics of the patients in C-BEYOND were very well balanced across the two arms, including age, sex, BMI, race and ethnicity, status, viral load, and HIV coinfection.

請看投影片第 7 頁，您可以看到 C-BEYOND 兩組患者的基線特徵在各方面都非常均衡，包括年齡、性別、BMI、種族與族裔、狀態、病毒量，以及 HIV 共感染情況。

On slide 8, C-BEYOND enrolled the HCV population clinicians are treating in North America today, which looks meaningfully different from the population studied a decade ago. In our trial, more than half of the patients reported injection drug use as the route of HCV transmission. Approximately 89% were taking concomitant medications, two-thirds had a psychiatry disorder, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol.

在投影片第 8 頁，C-BEYOND 納入的是目前北美臨床醫師正在治療的 HCV 族群，與十年前研究的族群相比有顯著差異。在我們的試驗中，超過一半的患者表示其 HCV 傳播途徑為注射藥物使用。約 89% 的患者正在使用合併用藥，三分之二有精神科疾病，且超過 10% 的患者提前停止治療、失訪或未遵循試驗方案。

Current standard of care regimens have challenges where it matters most. Modern protease inhibitor-containing regimens carry DDI limitations that restrict or complicate use in many of these patients, while Epclusa requires 12 weeks of treatment. In our market research, only 6% of 157 high-prescribing US physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications.

現行標準治療方案在最關鍵之處仍面臨挑戰。現代含蛋白酶抑制劑的療程具有藥物交互作用（DDI）限制，使得在許多此類患者中的使用受到限制或更為複雜；而 Epclusa 則需要 12 週療程。在我們的市場調查中，157 位美國高處方量醫師中僅有 6% 表示沒有未被滿足的需求；醫師仍持續指出關鍵優先事項，例如更短療程、高療效，以及較少禁忌症。

Let's now review the Phase 3 results on slide 9. In the primary endpoint MITT population, BEM-ruzasvir achieved a 93.9% SVR rate compared with 94.8% for SOF/VEL at week 24, encompassing SVR12, the accepted definition of cure for HCV. This result met the primary endpoint of statistical non-inferiority within the pre-specified 5% margin. BEM-ruzasvir delivered cure rates comparable to the standard of care while offering an eight-week regimen for non-cirrhotic patients compared to 12 weeks for SOF/VEL.

現在讓我們在投影片第 9 頁回顧第 3 期結果。在主要終點 MITT 族群中，BEM-ruzasvir 於第 24 週達到 93.9% 的 SVR 率，相較之下 SOF/VEL 為 94.8%；此結果涵蓋 SVR12，即 HCV 公認的治癒定義。該結果在預先設定的 5% 界值內，達成主要終點的統計學非劣性。BEM-ruzasvir 在提供與標準治療相當的治癒率同時，對無肝硬化患者可提供 8 週療程，相較於 SOF/VEL 的 12 週療程。

On slide 10, in the non-cirrhotic MITT population, BEM-ruzasvir achieved a 93.5% SVR rate with eight weeks of treatment, compared with 94.6% for SOF/VEL with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate with 12 weeks of treatment. Populations are not powered for statistical analysis.

在第10張投影片中，於非肝硬化的MITT族群，BEM-ruzasvir以8週治療達到93.5%的SVR率，相較之下，SOF/VEL以12週治療的SVR率為94.6%。在代償性肝硬化患者中，兩個治療組皆以12週治療達到95.4%的SVR率。各族群樣本數不足以進行統計分析。

On slide 11 is the safety summary. Overall adverse events were comparable between the two treatment arms. Most treatment-emergent events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drugs, and while there were no deaths in the BEM-ruzasvir arm, three deaths in the SOF/VEL arm were observed, but not related to the study drug. Similarly, there were no early treatment discontinuations related to the study drugs.

第11張投影片為安全性摘要。整體不良事件在兩個治療組之間相當。多數治療期間出現的不良事件為輕度至中度，且在各治療組間分布均衡。未出現由研究藥物導致的嚴重不良事件；此外，BEM-ruzasvir組未發生死亡，而SOF/VEL組觀察到3例死亡，但與研究藥物無關。同樣地，未出現與研究藥物相關的提前停藥。

Moving to slide 12, real-world adherence and discontinuation of treatment with loss to follow-up remains a major barrier in HCV treatment today and helps explain why current SVR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies. Indeed, as you can see in more recent studies, the intent-to-treat SVR rates fall below the rates reflected in labels established a decade ago, including rates as low as 74% among people who injected drugs, with rates consistently in the low 90s.

來到第12張投影片，真實世界中的用藥依從性，以及因失訪而中止治療，至今仍是HCV治療的主要障礙，並有助於解釋為何目前核准療法的SVR率可能低於10年前原始關鍵性試驗所報告的比率。確實，如您在較近期研究中所見，意向治療（intent-to-treat）的SVR率低於十年前標籤所反映的比率；其中在注射藥物者族群中甚至低至74%，而其他族群的比率則一貫落在90%出頭。

Slide 13 summarizes the top-line results for C-BEYOND. The trial met its primary and secondary endpoints with BEM-ruzasvir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotypes. Virological failure rates were low and comparable across treatment arms. BEM-ruzasvir was generally safe and well-tolerated with a safety profile comparable to SOF/VEL.

第13張投影片總結了C-BEYOND的主要結果。該試驗達成其主要與次要終點，BEM-ruzasvir不論是否肝硬化皆展現一致的SVR率，且在各基因型上表現穩健。病毒學失敗率偏低，且在各治療組間相當。BEM-ruzasvir整體安全且耐受性良好，其安全性概況與SOF/VEL相當。

On slide 14 is the patient populations and analysis for C-FORWARD, our second Phase 3 trial, being conducted outside of North America to enable a broad pangenotypic label. It is fully enrolled and enriched for genotypes 1b, 3, 4, 5, and 6, using the same non-inferiority methodology and the same powering assumptions. Together, the two Phase 3 studies will form a comprehensive global data package for regulators worldwide.

第14張投影片為C-FORWARD（我們第二項第3期試驗）的患者族群與分析；該試驗在北美以外地區進行，以支持廣泛的泛基因型標籤。目前已完成收案，並富集基因型1b、3、4、5與6，採用相同的非劣性方法學與相同的檢定力假設。這兩項第3期研究合併後，將為全球監管機關提供完整的全球性資料套件。

I will now hand the call over to Janet, our Chief Development Officer.

我現在把電話會議交給我們的研發長Janet。

Thank you, Arantxa. Good afternoon, everyone. Moving on to slide 16. BEM-ruzasvir is a next-generation, pangenotypic, once-daily, fixed-dose regimen. Bemnifosvir is the most potent nucleotide we are aware of, being approximately 10 times more active than sofosbuvir in vitro. And ruzasvir is a picomolar potency pangenotypic NS5A inhibitor.

謝謝你，Arantxa。各位下午好。接著看第16張投影片。BEM-ruzasvir是一種次世代、泛基因型、每日一次的固定劑量療程。Bemnifosvir是我們所知最具效力的核苷酸類藥物，在體外活性約為sofosbuvir的10倍。而ruzasvir則是具皮莫耳（picomolar）效力的泛基因型NS5A抑制劑。

Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared to Epclusa and Mavyret, BEM-ruzasvir is the only regimen positioned to offer the full combination of short eight-week duration for non-cirrhotic patients, protease inhibitor-free composition, low potential for drug-drug interactions, and no food effects. That combination is what defines a potential best-in-class profile.

兩者合併已給予數千名受試者使用，整體安全性與耐受性普遍良好。相較於Epclusa與Mavyret，BEM-ruzasvir是唯一有望同時提供以下完整組合的療程：非肝硬化患者可採短至8週療程、不含蛋白酶抑制劑、藥物—藥物交互作用潛在風險低，以及不受食物影響。這樣的組合定義了其潛在的同類最佳（best-in-class）特徵。

On slide 17, the drug-drug interaction profile is a key differentiator for BEM-ruzasvir. Roughly 80% to 90% of hepatitis C patients in the United States take concomitant medications, and prescribers strongly prefer therapies that are simple to prescribe. Across the classes of oral contraceptives, protease inhibitors, and integrase inhibitor HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors and other acid-reducing therapies, BEM-ruzasvir is expected to be broadly compatible where competitors carry contraindications or require dose modifications.

第17張投影片顯示，藥物—藥物交互作用（DDI）概況是BEM-ruzasvir的關鍵差異化優勢。美國約有80%至90%的C型肝炎患者同時使用其他合併用藥，而處方醫師強烈偏好開立簡單的治療方案。在口服避孕藥、蛋白酶抑制劑與整合酶抑制劑的HIV療程、他汀類、免疫抑制劑、地高辛、質子幫浦抑制劑以及其他抑酸治療等各類藥物中，預期BEM-ruzasvir具有廣泛相容性；相較之下，競品往往存在禁忌症或需要調整劑量。

Fewer drug interactions mean fewer specialist referrals, fewer treatment delays, and more patients actually starting and completing therapy. Today's treatment challenge is less about efficacy and more about treatment duration, adherence, drug-drug interactions, and access. Based on the potential profile of BEM-ruzasvir, we believe our regimen is well-positioned to address these barriers and expand the number of patients successfully treated.

較少的藥物交互作用意味著較少轉介專科、較少治療延遲，以及更多患者真正開始並完成治療。當今治療挑戰較少在於療效，而更多在於療程長度、依從性、藥物—藥物交互作用與可近性。基於BEM-ruzasvir的潛在特徵，我們相信本療程具備良好定位，可解決這些障礙並擴大成功治療的患者人數。

I'll now turn the call over to John Vavricka, our Chief Commercial Officer.

我現在把電話會議交給我們的商務長John Vavricka。

Thank you, Janet. Let's move on to slide 19. I want to address what we believe is a widely misunderstood dynamic in the HCV market. Wall Street often looks at revenue trends for approved HCV therapies and concludes that this is a declining market. However, the prevalence and treatment data tell a different story.

謝謝你，Janet。接著看第19張投影片。我想談談我們認為在HCV市場中一個被廣泛誤解的動態。華爾街常以已核准HCV療法的營收趨勢來看，並得出這是一個下滑市場的結論。然而，盛行率與治療數據呈現的是不同的故事。

Early diagnosed patients with HCV infections continue to outpace patients treated annually, and that gap is widening. In 2025, only around 50% of those newly infected patients were treated. The result is a growing HCV-infected population moving towards 4 million people in the United States, which is an expanding addressable market. The test-and-treat model of care is emerging as a reality and will serve as a critical lever to close the gap of untreated patients.

早期被診斷的HCV感染患者數仍持續超過每年接受治療的患者數，而且這個差距正在擴大。在2025年，新感染患者中僅約50%接受治療。其結果是，美國HCV感染人口持續增加，正朝向400萬人邁進，這代表可觸及市場正在擴大。「檢測即治療」（test-and-treat）的照護模式正逐步成為現實，並將成為縮小未治療患者缺口的關鍵槓桿。

It will enable seamless rapid diagnosis and treatment initiation at the same point-of-care visit, reduce barriers for prescribing, and drastically reduce patient attrition even before treatment begins. This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in the United States. I do believe our regimen's profile is optimal for this model of care.

它將使在同一次就診的照護現場即可完成快速診斷並啟動治療，降低開立處方的障礙，並在治療開始前就大幅降低患者流失。此模式獲得跨黨派的廣泛支持，並正以作為美國邁向HCV根除的途徑而累積動能。我確實相信，我們療程的特徵最適合此一照護模式。

Let's move on to slide 20. Current HCV market dynamics create a clear opportunity for BEM-ruzasvir. Short-duration regimens continue to gain share, and prescribing is increasingly driven by polypharmacy and comorbidities.

接著看第20張投影片。目前HCV市場動態為BEM-ruzasvir創造了明確機會。短療程方案持續提升市占，而處方決策也愈來愈受到多重用藥與共病影響。

New infections keep outpacing treatment, and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strengths of BEM-ruzasvir. We believe a potential best-in-class profile can expand treatment eligibility and improve treatment completion for patients whose medications, comorbidities, and life circumstances have historically limited access and adherence. In addition, there is market growth potential with a simplified therapy and a focused commercialization.

新感染人數持續超過治療人數，同時競爭對手的商業推廣力度也在下降。上述每一項趨勢都直接對應到BEM-ruzasvir的優勢。我們相信，潛在的同類最佳特徵可擴大治療適用性，並提升那些因既有用藥、共病與生活情境而歷來受限於可近性與依從性的患者之治療完成率。此外，透過簡化療法與聚焦式商業化，市場亦具備成長潛力。

Moving on to slide 21, our market research supports strong uptake of BEM-ruzasvir. Among high-volume DAA prescribers, 76% said they would be extremely likely to prescribe BEM-ruzasvir. And the research predicts roughly half of both non-cirrhotic and compensated cirrhotic patients would receive BEM-ruzasvir relative to Epclusa and Mavyret.

接著看第21張投影片，我們的市場研究支持BEM-ruzasvir將有強勁的採用率。在高開立量的DAA處方醫師中，76%表示他們極有可能會開立BEM-ruzasvir。研究亦預測，相較於Epclusa與Mavyret，約有一半的非肝硬化與代償性肝硬化患者將會使用BEM-ruzasvir。

On slide 22, we believe BEM-ruzasvir is uniquely positioned to capture untreated patients and grow the market, not simply to compete for existing share. Currently, only about half of diagnosed patients in the US are treated annually, leaving roughly 75,000 untreated new infections last year on top of the already large prevalent pool of patients.

在第22張投影片，我們認為BEM-ruzasvir具備獨特定位，可吸引尚未治療的患者並擴大市場，而不僅僅是爭奪既有市占。目前，美國每年僅約有一半的已診斷患者接受治療；此外，去年約有75,000例新增感染未接受治療，且是在原本已相當龐大的現存患者池之上。

In 2025, US net sales were $1.3 billion, representing 50% of the global net sales of $2.6 billion. With its differentiated profile, BEM-ruzasvir is uniquely positioned to expand the market, potentially up to $2.5 billion annually in the United States.

2025年，美國淨銷售額為13億美元，占全球淨銷售額26億美元的50%。憑藉其差異化特性，BEM-ruzasvir具備獨特優勢可擴大市場，在美國的年市場規模潛力可望提升至最高25億美元。

Slide 23. Taken together, we see peak annual US net revenue potential in excess of $700 million. That's anchored on a widening gap between infections and cures, up to 4 million infected, and the increasing number of untreated people in the United States as a total addressable market. The pricing is expected to be in line with existing branded DAA regimens.

第23張投影片。綜合來看，我們認為美國年度淨營收峰值潛力可超過7億美元。這一預期建立在感染與治癒之間差距擴大（感染人數可達400萬）、以及美國未治療人數增加所形成的總可服務市場之上。預期定價將與現有品牌DAA療程一致。

In closing, on slide 24, we continue to advance our commercial readiness activities across all key areas. The HCV prescriber base is highly concentrated, with approximately 7,800 physicians writing roughly 80% of all DAA prescriptions in the US. We can reach the vast majority of this market with a focused specialty sales force of approximately 75 to 100, including sales representatives, sales managers, and medical science liaisons.

最後，在第24張投影片，我們持續在所有關鍵領域推進商業化就緒工作。HCV處方醫師基礎高度集中，美國約有7,800名醫師開立約80%的所有DAA處方。我們可透過約75至100人的聚焦型專科銷售團隊（包含業務代表、業務經理與醫學科學聯絡員）觸及此市場的絕大多數。

All components and processes for large-scale manufacturing are in place. Commercial launch supply is already underway with low cost of goods relative to the expected net price. And our four-week dosing blister card packaging supports patient convenience and adherence. We believe these factors position us for a short time to profitability following a launch.

大規模製造所需的所有組件與流程均已到位。商業上市供應已在進行中，且相對於預期淨價格，銷貨成本偏低。此外，我們的四週劑量泡殼卡包裝有助於提升患者便利性與用藥依從性。我們相信這些因素使我們在上市後可於較短時間內達到獲利。

I'll now turn the call back to Janet to review the hepatitis E program.

接下來我把電話交回給Janet，請她回顧戊型肝炎（hepatitis E）計畫。

Thank you, John. On slide 26, in July, we initiated our first-in-human Phase 1 clinical trial of AT-587. The study is being conducted in healthy volunteers with the primary objectives of evaluating safety, tolerability, and pharmacokinetics. It is a randomized, double-blind, placebo-controlled design with sequential dose escalation and an embedded food effect assessment.

謝謝你，John。在第26張投影片，7月我們啟動了AT-587的首次人體（first-in-human）第一期臨床試驗。本研究在健康受試者中進行，主要目標是評估安全性、耐受性與藥物動力學。研究採隨機、雙盲、安慰劑對照設計，進行序列式劑量遞增，並內嵌食物效應評估。

The study includes both single-ascending and multiple-ascending dose phases, providing flexibility to refine dose levels as data emerge, and with dose progression informed by real-time safety and PK review. We have recently completed the first cohort and are moving forward to the next cohort. Hepatitis E has no approved therapy, so this is a potential first-in-class opportunity that provides a meaningful pipeline program beyond hepatitis C.

本研究包含單次遞增劑量與多次遞增劑量兩個階段，讓我們能在資料逐步出現時更靈活地調整劑量水準，且劑量推進將依據即時的安全性與PK審查結果。我們近期已完成第一個隊列，並正推進至下一個隊列。戊型肝炎目前尚無核准療法，因此這是一個潛在的同類首創（first-in-class）機會，也為丙型肝炎之外提供一個具意義的產品線計畫。

I'd like to turn the call over now to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials.

接下來我想把電話交給我們的財務長Andrea Corcoran，討論Atea的財務狀況。

Thanks, Janet. As Jonae mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of 2026. The statement of operations and balance sheet can be found on slides 28 and 29. We are pleased to report that our cash and investments balance was $219.5 million at June 30, 2026.

謝謝你，Janet。如Jonae在開場致詞中提到的，我們今天稍早發布新聞稿，公布2026年第二季的財務結果。損益表與資產負債表可見於第28與第29張投影片。我們很高興報告，截至2026年6月30日，我們的現金與投資餘額為2.195億美元。

The funds we expended in the second quarter were principally directed to the advancement of our HCV Phase 3 clinical trials, C-BEYOND and C-FORWARD, and to a lesser extent to the completion of clinical trial start-up activities for the first-in-human study of AT-587, which Janet just described is our product candidate for the treatment of HEV.

我們在第二季支出的資金主要用於推進HCV第三期臨床試驗C-BEYOND與C-FORWARD；另有較小部分用於完成AT-587首次人體研究的臨床試驗啟動相關活動。Janet剛才也說明，AT-587是我們用於治療HEV的候選產品。

As we have noted recently, milestone events in each program have been realized with the announcement of positive top-line results in C-BEYOND, the completion of patient enrollment in C-FORWARD, and the initiation of the first-in-human clinical study of AT-587.

如我們近期所提及，各計畫的里程碑事件均已達成，包括宣布C-BEYOND取得正向的主要（top-line）結果、完成C-FORWARD的患者入組，以及啟動AT-587的首次人體臨床研究。

In the first six months of 2026, our R&D expenses increased compared to the prior year, principally driven by higher external spend related to the HCV Phase three program and incremental HEV preclinical and clinical trial start-up activities. The incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock-based compensation and payroll-related costs.

2026年前六個月，我們的研發費用較去年同期增加，主要由HCV第三期計畫相關的外部支出增加，以及HEV臨床前與臨床試驗啟動活動的新增支出所帶動。這些新增費用部分被較低的內部費用所抵銷，主要因為以股票為基礎的薪酬與薪資相關成本下降。

With respect to G&A, there was a decrease in the first six months of 2026 compared to the prior year due principally to lower salaries and lower wages as well as lower stock-based compensation. During the second half of 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and value-creating advancement of our HCV and HEV product candidates.

在一般及行政（G&A）方面，2026年前六個月較去年同期下降，主要由於薪資與工資降低，以及以股票為基礎的薪酬降低。在2026年下半年，我們計畫在維持嚴謹財務紀律的同時，仍將高度聚焦於執行力，以及推進HCV與HEV候選產品以創造價值。

As we complete C-FORWARD, prepare to submit our regulatory filings, and engage in pre-launch activities, the substantial majority of our spending will remain focused on the advancement of our hepatitis C program. With the resources in hand at the end of June, we expect to realize these value-creating milestones for both programs, and we project our cash runway to extend through 2027.

隨著我們完成C-FORWARD、準備提交法規申報文件並展開上市前活動，我們的絕大部分支出仍將聚焦於推進丙型肝炎計畫。以6月底所持有的資源，我們預期可在兩個計畫上實現這些創造價值的里程碑，並預估我們的現金可支撐至2027年。

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

接下來我把電話交回給Jean-Pierre作結語。

Thank you, Andrea. In closing, on slide 30, our milestones are clear and all near-term. We completed patient enrollment for C-FORWARD in June, and top-line results are expected in early Q1 '27. Pending positive results from C-FORWARD, our NDA submission is anticipated in the second quarter of 2027. In parallel -- (technical difficulty)

謝謝你，Andrea。最後，在第30張投影片，我們的里程碑清楚且皆為近期目標。我們已於6月完成C-FORWARD的患者入組，預期主要（top-line）結果將於2027年第一季初公布。若C-FORWARD結果正向，我們預計於2027年第二季提交NDA申請。同時--（技術問題）

Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. Thank you. JP, you may continue.

各位女士先生，請保持在線。我們遇到技術問題。再次提醒，請保持在線。謝謝。JP，您可以繼續。

I was disconnected. So in parallel, our hepatitis E program is progressing very well and advancing toward proof of concept in 2027. We believe that BEM-ruzasvir's potential best-in-class profile, including high efficacy, short treatment duration, a low risk of drug-drug interactions, and no food effect, position us to meaningfully contribute to the goal of HCV eradication in the US and globally. Based on our projections, we expect a short time to profitability after the anticipated mid-2028 launch. We look forward to keeping you updated on our progress.

我剛才斷線了。因此同時，我們的戊型肝炎計畫進展非常順利，並正朝向於2027年取得概念驗證（proof of concept）邁進。我們相信，BEM-ruzasvir具備潛在同類最佳（best-in-class）的特性，包括高療效、療程短、藥物—藥物交互作用風險低、且不受食物影響，將使我們能在美國及全球的HCV根除目標上做出實質貢獻。根據我們的預測，在預期於2028年年中上市後，我們可望在短時間內達到獲利。我們期待持續向各位更新我們的進展。

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

那麼，接下來我把電話交回給接線員。

(Operator Instructions) Andy Hsieh, William Blair.

(接線員指示) Andy Hsieh，William Blair。

So my first question has to do with -- I think JP, you mentioned about the new mechanism of action. I'm curious, with the assembly disruption mechanism, how do you get that into the label? That's number one.

所以我的第一個問題是——我想 JP，你提到新的作用機轉。我很好奇，針對這個「組裝破壞」機制，你們要如何把它寫進藥品標籤（label）？這是第一點。

Number two, it has to do with the test-and-treat model. I think John mentioned about that. He also mentioned about the one-month blister pack. Based on some of the conversations with KOLs, they really like to see a kind of test-and-treat model. On top of that, you basically give all the drugs in one setting. And I'm just wondering what steps do you have to take to really reach that goal?

第二點，與「檢測後立即治療」（test-and-treat）模式有關。我想 John 提到過。他也提到一個月的泡殼包裝。根據我與一些 KOL 的對話，他們真的很希望看到一種檢測後立即治療的模式。此外，你們基本上是在同一次就把所有藥物都給到位。我只是想知道，你們需要採取哪些步驟才能真正達成那個目標？

Okay. First, Andy, thanks for your scientific knowledge. And we have not released yet all the data. And we continue to build upon this new MOA. And we anticipate to share with the FDA early next year when we'll have the full dataset.

好的。首先，Andy，謝謝你的科學專業。我們目前還沒有公布所有數據。我們也會持續在這個新的 MOA 上累積更多證據。我們預期在明年年初、當我們拿到完整資料集時，會與 FDA 進行分享。

So it's a little bit early for me to discuss about it, but obviously we will present at scientific meetings and share with the FDA the impact that we believe that this supplemental important MOA for BEM is totally unique. John, you want to address the second question of Andy?

所以現在對我來說還有點早，不便深入討論；但很明顯地，我們會在科學會議上發表，並與 FDA 分享我們所認為的：這個對 BEM 而言重要的補充性 MOA 之影響，而且它是完全獨特的。John，你要回應 Andy 的第二個問題嗎？

Sure. Thanks, Andy. Yes, test-and-treat is what the KOLs are looking to, what they do believe will actually increase the number of patients that are treated. And you are correct that the way that they would like to practice it is the patient is diagnosed and then immediately treated, just like the other products that are out there. So we will have both bottles and these blister packs.

當然。謝謝，Andy。是的，檢測後立即治療正是 KOL 們所期待的，他們也相信這確實會增加接受治療的病人數。你說得沒錯，他們希望的實務做法是：病人被診斷後就立刻開始治療，就像目前市面上的其他產品一樣。因此我們會同時提供瓶裝與這些泡殼包裝。

And similar to the other products, you would have to give two blister packs out if that's what the patient required, or two bottles out. Very similar to what you have going on today. The reason for the blister packs was it was just identified as a more convenient way for the HCV patients, and we're trying to do everything we can to make them take their medication and be more compliant. It's just a matter of the quantity that you'll give them at that time.

而且與其他產品類似，如果病人需要，你就必須發兩盒泡殼包裝，或是發兩瓶。這和你們今天看到的情況非常相近。之所以做泡殼包裝，是因為它被認為對 HCV 病人更方便；我們也在盡一切努力讓他們按時服藥、提高依從性。這只是當下要給多少數量的問題。

Does that answer your question, Andy?

這樣有回答到你的問題嗎，Andy？

Yes, so I guess the question also has to do with kind of refilling requirements. So after the first month, based on payers or other stakeholders. Basically, how do you eliminate that step to get a refill?

有，所以我想這個問題也與補藥（refill）的要求有關。也就是第一個月之後，基於付款方或其他利害關係人。基本上，你們要如何消除需要再走一次流程才能拿到續配藥的那一步？

So, I don't have that answer for you today. What I can tell you is that in talking with physicians who do practice test-and-treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount without a refill to those patients. And that would be specific to the programs. So you are correct, where it is existing, they do give them to everyone. Would every physician be able to provide test-and-treat today?

所以，今天我沒有辦法給你確切答案。我能告訴你的是：在與那些在各自州內確實執行檢測後立即治療的醫師交流時，這些州的付款方允許他們在不需要補藥的情況下，直接給病人適當的療程用量。而這會取決於各個方案的具體規定。所以你說得對，在已經存在這種做法的地方，他們確實會一次給到每個人。但今天每位醫師都能提供檢測後立即治療嗎？

That's part of the challenges and the mechanisms that will have to be worked out. But I can tell you in talking to these physicians who have implemented the test-and-treat and have provided the treatment at that visit, they do see great promise and great success. The one thing that they were very excited about for our profile is that it really would be the best profile to use in the test-and-treat because of the potential lack of drug-drug interactions and not have to worry about what a patient is either taking now or will be taking, and it will offer the shortest course of therapy.

這就是其中一部分挑戰，以及需要被釐清的機制。但我可以告訴你，和這些已經導入檢測後立即治療、並在當次就診就提供治療的醫師談過後，他們確實看到了很大的潛力與很高的成功率。他們對我們產品特性最興奮的一點是：由於可能缺乏藥物—藥物交互作用，他們不必擔心病人現在正在服用或未來將要服用什麼藥；而且它也能提供最短的療程，因此會是最適合用於檢測後立即治療的最佳特性組合。

Jonathan Miller, Evercore ISI.

Jonathan Miller，Evercore ISI。

Hello, this is Yuan Yuan for Jon. So I'd like to touch on the AASLD simplified treatment algorithm. So can you walk us through the process and timeline to get the treatment included in the guideline and what evidence do you think will be most important for the panel to see from the C-BEYOND and C-FORWARD results to include them in the treatment algorithm?

你好，我是 Yuan Yuan，代 Jon 發問。我想談一下 AASLD 的簡化治療演算法。你們能否帶我們了解一下，讓該治療被納入指引的流程與時間表？以及你們認為，委員會在審視 C-BEYOND 與 C-FORWARD 結果時，最重要、最希望看到哪些證據，才會把它們納入治療演算法？

Arantxa, you want to address that?

Arantxa，你要回應這題嗎？

Sure. I think what they are looking for is a best-in-class profile. So this is what we are offering here. It's the eight-week for the majority of the patients. And once they see these results, and we obviously get a label and an approval, I think that it will not be difficult with this profile to get it into treatment algorithms and have it prescribed by physicians. We're hearing really excellent feedback from our PIs.

當然。我認為他們在尋找的是同級最佳（best-in-class）的產品特性。而這正是我們在這裡所提供的。對大多數病人而言是八週療程。一旦他們看到這些結果，而且我們也確實取得標籤（label）與核准，我認為以這樣的特性，要把它納入治療演算法並讓醫師開立處方並不困難。我們也從主要研究者（PI）那裡聽到非常正面的回饋。

Okay, thank you. I just want to add one point, is that for both the North American trial and the C-FORWARD, so in 17 countries, it's absolutely remarkable that we were able to fully enroll about 900 patients in less than eight months. So with 120 clinical sites with a high demand. And we could see at the end that the demand was going exponentially and we had actually to unfortunately stop because we could not go beyond much more in terms of the number of targeted patients. But there was really a high demand for this clinical trial in both North America, the US, as well as in these 17 countries.

好的，謝謝。我想再補充一點：無論是北美試驗還是 C-FORWARD（涵蓋 17 個國家），我們能在不到八個月內完成約 900 名病人的全數收案，這真的非常了不起。這是在 120 個臨床試驗中心、且需求非常高的情況下完成的。而且到最後我們看到需求呈指數型上升；很遺憾我們必須停止，因為在目標病人數方面我們無法再大幅超出。但無論在北美、在美國，或是在這 17 個國家，這項臨床試驗的需求都非常高。

Maxwell Skor, Morgan Stanley.

Maxwell Skor，Morgan Stanley。

Regarding the non-inferiority, which also cleared on the per-protocol secondary in C-BEYOND, which is the C-FORWARD's primary endpoint for the EMA, how much does that lift your confidence going into the early 1Q '27 readout? Also, how comparable do you expect the baseline characteristics to be across the two studies given C-FORWARD's different geographies and genotype mix? And finally, if I can ask just one more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B, and how they're reshaping the competitive landscape?

關於非劣性（non-inferiority），在 C-BEYOND 中也在依方案（per-protocol）的次要分析中達標；而這個指標是 C-FORWARD 針對 EMA 的主要終點。這在多大程度上提升你們對 2027 年第一季初讀出（readout）的信心？另外，考量到 C-FORWARD 的地理區域與基因型組合不同，你們預期兩項研究的基線特徵可比性會有多高？最後，如果我可以再問一題，能否再多談一些定價改革、Medicare Part D 與 340B，以及它們如何正在重塑競爭格局？

Great question. Arantxa, you want to tackle? We are going to basically report that at scientific meetings, but we do not worry. We always worry, but we do not worry on the per-protocol. As you have seen, it's quite a bit of discontinuation, but we have sufficient power. So why don't you chime in as well and address the difference of patients, which actually, it is substantial. Arantxa, can you go ahead?

問得很好。Arantxa，你要來回答嗎？我們基本上會在科學會議上報告這些內容，但我們不擔心。我們總是會擔心，但對於依方案（per-protocol）我們並不擔心。如你所見，確實有相當程度的中止（discontinuation），但我們有足夠的統計把握度（power）。所以你也一起補充一下，並說明病人差異——其實差異相當大。Arantxa，你可以開始嗎？

Yes, I think, Max, I mean, it's a great question. So for the C-FORWARD, we are more likely to see genotypes, obviously, that are not in the United States. So the United States predominantly is 1a. Ex-US, we're going to be seeing more of the 1bs. And then some of the rare genotypes that we made an extraordinary effort to get, genotypes which are not common in the United States.

是的，我想，Max，我是說，這是個很好的問題。因此就 C-FORWARD 而言，我們更可能會看到一些基因型，顯然是美國沒有的。所以美國以 1a 為主。在美國以外，我們會看到更多 1b。另外還有一些罕見的基因型，我們付出了非同尋常的努力去納入，也就是在美國並不常見的基因型。

And so it will differ in terms of genotypes, but I want to remind you that a lot of these genotypes we already treated in Phase 2 where we had genotype 3 in particular, excellent results. In terms of the population, we think we'll see probably less transmission through the IV drug use, you know, that kind of population that we also saw in the Phase 2, because globally there is still quite a lot of transmission through things like dental procedures, transplants, even blood transfusions. And the population ex-US in general tends to report less frequently adverse events. They tend to be less lost to follow-up.

因此在基因型方面會有所不同，但我想提醒你，這些基因型中有很多我們在第二期試驗就已經治療過，尤其是基因型 3，結果非常出色。就受試者族群而言，我們認為可能會看到較少透過靜脈注射藥物使用（IV drug use）而傳播的情況，也就是我們在第二期試驗中也看到的那類族群，因為在全球範圍內，仍有相當多的傳播是透過例如牙科處置、移植，甚至輸血等途徑。而一般來說，美國以外的族群較少回報不良事件。他們也較不容易在追蹤中失聯。

They tend to be a little more compliant with the protocol. So if anything, we think we're going to be seeing a more adherent population, and maybe even a little bit closer to what we saw in the Phase 2, where we had already excellent results. I think that was your main question for me. There was another one, though.

他們通常對試驗方案的遵從性也會更好一些。所以如果有什麼差異，我們認為會看到一個更遵從治療的族群，甚至可能更接近我們在第二期試驗中看到的情況，而當時我們已經取得了非常好的結果。我想這就是你主要想問我的問題。不過還有另一個問題。

Yes. I'm sorry, but do I think for John? Yes.

是的。抱歉，但你是要我回答 John 的問題嗎？是的。

Sure. So, Max, I think your question was on pricing reform and the various generics and other legislative 340Bs reshaping the landscape. And you are correct. And it depends on what segment that you're more heavily weighted in. And currently, the two products, whether it's Mavyret or Epclusa, have different percentages of their business from Medicaid or Medicare.

當然。所以，Max，我想你的問題是關於定價改革，以及各種學名藥與其他 340B 相關立法如何重塑市場格局。你說得沒錯。而這取決於你在什麼細分市場的比重較高。目前這兩個產品，不論是 Mavyret 或 Epclusa，其業務中來自 Medicaid 或 Medicare 的占比不同。

And those changes have already started to take effect. So, for instance, having a higher percentage of Medicare patients, the Inflation Reduction Act has had an effect on that. In the past, manufacturers weren't responsible for a percentage of the total prescription cost there, and that is happening now. As far as the other things you mentioned like generics and so forth, which is MFN type pricing and its effect on Medicaid. It could affect the Medicaid discounts that are currently being offered.

而這些變化已經開始產生影響。例如，若 Medicare 病患占比較高，《通膨削減法案》（Inflation Reduction Act）已對此產生影響。過去，製造商不需要承擔其中總處方成本的一部分比例，但現在已開始如此。至於你提到的其他事項，例如學名藥等，也就是 MFN 類型定價及其對 Medicaid 的影響。這可能會影響目前所提供的 Medicaid 折扣。

But there's something interesting, Max, and that is when you start looking at the pricing differential between the US, for instance, and a lot of these generics or mainly EU countries or Western countries, the pricing isn't as dramatically different from the US as other types of pharmaceutical products. And we were kind of shocked at that. So the impact will not be as dramatic as some people think.

但有一點很有意思，Max，那就是當你開始比較美國與許多這些學名藥（或主要是歐盟國家或西方國家）之間的定價差異時，價格其實不像其他類型的藥品那樣與美國有那麼巨大的差距。我們對此有點震驚。因此其影響不會像有些人想的那麼劇烈。

The other thing to bear in mind is that some manufacturers are already cutting direct deals with individual state Medicaid agencies beyond the statutory discounts to be provided. And so from that standpoint, the difference between the extra rebates that they're already providing and what the generics or the extra rebates for MFN might be, which could theoretically be smaller. But that's what we know now.

另一個需要記住的是，有些製造商已經在法定折扣之外，與個別州的 Medicaid 機構直接達成協議。因此從這個角度來看，他們目前已提供的額外回扣，與學名藥或 MFN 可能帶來的額外回扣之間的差距，理論上可能更小。但這就是我們目前所掌握的情況。

The other last thing you mentioned was 340B. I think the proposed legislative or the administrative changes that are happening for 340B, I think will be favorable to the manufacturers in the sense that, you know, if the current thinking goes through, instead of providing an outright discounted price, that it would be handled through a rebate mechanism, thus allowing the manufacturers to make sure that they're not getting double-counted on both Medicaid and 340B. But so we'll have to stay tuned to see what happens with that.

你最後提到的另一件事是 340B。我認為目前針對 340B 正在推動的立法或行政變更，對製造商而言可能是有利的；也就是說，如果目前的思路得以落實，將不再是直接提供折扣價，而是透過回扣機制來處理，從而讓製造商能確保不會在 Medicaid 與 340B 兩邊被重複計算。不過我們還得持續關注後續發展。

Thank you very much. Max, I want to go back just to make sure that there is no misunderstanding here. On the C-FORWARD, the per-protocol is the primary endpoint for the EMA. But for the FDA, the MITT is the primary endpoint. Okay, so please be aware that the MITT as the C-BEYOND for C-FORWARD, the primary endpoint for the FDA will be the MITT. So essentially, we will have two primary endpoints in the C-FORWARD. I hope that just to make sure that --

非常感謝。Max，我想回到前面再確認一下，確保這裡沒有任何誤解。在 C-FORWARD 中，依方案分析（per-protocol）是 EMA 的主要終點。但對 FDA 而言，MITT 是主要終點。好的，所以請注意，MITT 與 C-BEYOND 一樣，對於 C-FORWARD 而言，FDA 的主要終點將是 MITT。因此基本上，我們在 C-FORWARD 會有兩個主要終點。我希望這只是為了確保--

Very helpful. Thank you for clarifying. I appreciate it.

非常有幫助。謝謝你澄清。我很感激。

Thanks. Okay. Very good. Thank you, Max. And any other questions?

謝謝。好的。很好。謝謝你，Max。還有其他問題嗎？

So thank you all for joining our second quarter conference call, and thank you for your continued support.

那麼感謝各位參加我們第二季的電話會議，也感謝各位持續的支持。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。