Prepared remarks
Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Second Quarter 2026 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. I would now like to turn the call over to Jonae R. Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Miss Barnes, please proceed.
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 outlines the topics we plan to discuss. You can access the press release as well as the slides that we will be reviewing today by going to the Investors section of our website at ir.ateapharma.com. With me from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet J. Hammond; Chief Commercial Officer, John F. Vavricka; Chief Medical Officer, Dr. Arantxa Horga; and Chief Financial Officer and Executive Vice President, Legal, Andrea J. Corcoran, who will be available for the Q&A portion of today's call. 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. With that, I will now turn the call over to 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 BEM/RZR versus Epclusa 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 bemrusasvir demonstrating statistical non-inferiority to Epclusa, the current standard of care. Importantly, this was the first successful Phase 3 trial in the global head-to-head HCV program, achieved in the real-world patient population that was polymedicated, psychiatrically complex, affected by substance use, and otherwise a challenging population. 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. Third, 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 complementary efficacy data across a broader range of genotypes and strengthen the pangenotypic regulatory package. 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 oral 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. I will now hand the call over to Arantxa, our Chief Medical Officer, to review our Phase 3 program.
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 U.S. and Canada, including patients coinfected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received bemrusasvir for 8 weeks or sofosbuvir/velpatasvir for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. On Slide 6, let's now review the C-BEYOND endpoints and patient populations. The primary efficacy endpoint is SVR, or sustained virologic response, 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 noncompliant, 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 U.S. NDA submission. 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, cirrhosis status, viral load, and HIV coinfection. 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 psychiatric disorder, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol. Current standard-of-care regimens have challenges where it matters most. A moderate protease inhibitor–containing regimen carries drug-drug interaction 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 U.S. physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications. Let's now review the Phase 3 results on Slide 9. In the primary endpoint mITT population, bemrusasvir achieved a 93.9% SVR rate compared with 94.8% for sofosbuvir/velpatasvir at week 24, encompassing SVR12, the accepted definition of cure for HCV. These results met the primary endpoint of statistical non-inferiority within the prespecified 5% margin. Bemrusasvir delivered cure rates comparable to the standard of care while offering an 8-week regimen for noncirrhotic patients compared to 12 weeks for sofosbuvir/velpatasvir. On Slide 10, in the non-cirrhotic mITT population, bemrusasvir achieved a 93.5% SVR rate with 8 weeks of treatment compared with 94.6% for sofosbuvir/velpatasvir with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate with 12 weeks of treatment. Patient subpopulations are not powered for statistical analysis. On Slide 11 is the safety summary. Overall, adverse events were comparable between the two treatment arms. Most treatment-emergent adverse events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drug, and while there were no deaths in the bemrusasvir arm, three deaths in the sofosbuvir/velpatasvir arm were observed but were not related to the study drug. Similarly, there were no early treatment discontinuations related to the study drugs. Moving to Slide 12, real-world adherence and discontinuation of treatment with loss to follow-up remain a major barrier in HCV treatment today and help 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, more recent studies' 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 inject drugs, with rates consistently in the low 90s in some studies. Slide 13 summarizes the top-line results for C-BEYOND. The trial met its primary and secondary endpoints, with bemnifosbuvir/ruzasvir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotypes. Virologic failure rates were low and comparable across treatment arms. Bemrusasvir was generally safe and well tolerated with a safety profile comparable to sofosbuvir/velpatasvir. On Slide 14 are 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. I will now hand the call over to Janet, our Chief Development Officer.
Thank you, Arantxa. Good afternoon, everyone. Moving on to Slide 16, BEM-ruzasvir is a next-generation, pangenotypic, once-daily fixed-dose regimen. Bemnifosbuvir is the most potent nucleotide we are aware of, being approximately tenfold more active than sofosbuvir in vitro, and is a picomolar-potency pangenotypic NS5B inhibitor. Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared to Epclusa and Mavyret, bemnifosbuvir/ruzasvir is the only regimen positioned to offer the full combination of short 8-week duration for noncirrhotic patients, protease inhibitor–free composition, low potential for drug interactions, and no food effect. That combination is what defines a potential best-in-class profile. On Slide 17, the drug interaction profile is a key differentiator for bemrusasvir. Roughly 80% to 90% of hepatitis C patients in the United States take concomitant medication, 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, proton pump inhibitors, other acid-reducing therapies, bemrusasvir is expected to be broadly compatible where competitors carry contraindications or require dose modification. 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 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. I will now turn the call over to John F. Vavricka, our Chief Commercial Officer.
Thank you, Janet. Let's move on to Slide 19. I want to address what we believe is a widely misunderstood dynamic in the 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. Newly 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 toward 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. 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 toward HCV eradication in the United States. We believe our regimen's profile is optimal for this model of care. Let's move on to Slide 20. The current HCV market dynamics create a clear opportunity for BEM/RZR. Short-duration regimens continue to gain share, and prescribing is increasingly driven by polypharmacy and comorbidities. New infections keep outpacing treatment, and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strength of BEM/RZR. 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. Moving on to Slide 21, our market research supports strong uptake of BEM/RZR. Among high-volume DAA prescribers, 76% said they would be extremely likely to prescribe BEM/RZR, and the research predicts roughly half of both noncirrhotic and compensated cirrhotics would receive BEM/RZR relative to Epclusa and Mavyret. On Slide 22, we believe BEM/RZR 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 U.S. are treated annually, leaving roughly 75,000 untreated new infections last year on top of the already large prevalent pool of patients. In 2025, U.S. net sales were $1.3 billion, representing 50% of the global net sales of $2.6 billion. With its differentiated profile, BEM/RZR is uniquely positioned to expand the market potentially up to $2.5 billion annually in the United States. Slide 23: taken together, we see peak annual U.S. net revenue potential in excess of $700 million that is 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. Pricing is expected to be in line with existing branded DAA market and DAA regimens. 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 U.S. 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. All components and processes for large-scale manufacturing are in place. Commercial drug supply is already underway with low cost of goods relative to the expected net price, and our 4-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. I will now turn the call back to Janet to review the hepatitis E program.
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. The study includes both single-ascending and multiple-ascending dose phases, providing flexibility to refine dose levels as data emerge, 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. I am going to turn the call over now to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials.
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 $220 million at June 30, 2026. 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 startup activities for the first-in-human study of AT-587, which Janet just described as our product candidate for the treatment of HEV. 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 enrollment in C-FORWARD, and the initiation of the first-in-human clinical study of AT-587. 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 3 program and incremental HEV preclinical and clinical trial startup activities. These incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock-based compensation and payroll-related costs. 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 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 value-creating advancement of our HEV and HCV product candidates. As we complete C-FORWARD, prepare to submit our regulatory filings, and engage in prelaunch 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. I will now hand the call back to Jean-Pierre for closing remarks.
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 2027. Pending positive results from C-FORWARD, our NDA submission is anticipated in the second quarter of 2027.
Questions and answers
In parallel, ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. We are experiencing a technical difficulty.
Hello?
Thank you.
JP, you may continue.
My apologies. 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 interactions, and no food effect — position us to meaningfully contribute to the goal of HCV eradication in the U.S. and globally. Based on our projection, we expect a short time to profitability after the anticipated mid-2028 launch. We look forward to keeping you updated on our progress. And with that, I will now turn the call back over to the operator.
Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the number keys. One moment, please, while we poll for questions. Our first question comes from Andy Hsieh with William Blair. Please go ahead.
Great. Thanks for taking our questions, and congratulations on the big milestone for the company. So my first question has to do with labeling. I think, JP, you mentioned about the new mechanism of action. I am curious, with the assembly disruption mechanism, how do you get that into the label? That is number one. And number two, it has to do with the test-and-treat model. I think, John, you mentioned that you would also mentioned the one-month blister pack. Based on some of the conversations with KOLs, they really like to see a test-and-treat model where you give all the drugs in one setting. I am just wondering what steps do you have to take to really reach that goal? Thank you so much.
Okay. First, Andy, thanks for your scientific knowledge here. We have not released all the data yet, and we continue to build upon this new mechanism of action. We anticipate sharing the full dataset with the FDA early next year. So it is a little bit early for me to discuss labeling in detail, but obviously we will present at scientific meetings and share with the FDA the impact that we believe this supplemental, important, and totally unique mechanism of action represents.
Sure. Thanks, Andy. Yes — test-and-treat is what the KOLs are looking to, and they do believe it will actually increase the number of patients that are treated. You are correct that the way they would like to practice it is the patient is diagnosed and then immediately treated. Similar to other products that are out there, we will offer both bottles and blister packs. For the blister packs, you would likely give two blister packs or two bottles if that is what the patient requires, very similar to what is done today. The reason for the blister packs was that it was identified as a more convenient way for HCV patients, and we are trying to do everything we can to help patients take their medication and be more adherent. It is just a matter of the quantity you will give them at that time. Does that answer your question, Andy?
Yeah. So I guess the question also has to do with the refill requirements. So after the first month, based on payers or other stakeholders, basically how do you eliminate that step to get a refill?
So I do not have a definitive answer for you today. What I can tell you is that in talking with physicians who practice test-and-treat within their respective states, the payers for those states have allowed them to give the appropriate amount without a refill to those patients, and that would be specific to the programs. Where test-and-treat exists, physicians do provide the full amount to patients. Would every physician be able to provide test-and-treat today? That is part of the challenge and mechanisms that will have to be worked out. What I can tell you from talking to these physicians who have implemented test-and-treat and provided the treatment at that visit is that they see great promise and great success. The one thing they are very excited about for our profile is that it would be very well suited for test-and-treat because of the potential lack of drug interactions and the short course of therapy, so you would not have to worry about what a patient is taking now or will be taking.
Great. Thanks so much.
Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead.
Hello. This is Xueyan Yang on for Jon. Thanks for taking my question, and congrats again on the Phase 3 data. I would like to touch on the AASLD simplified treatment algorithm. 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? Thank you.
Arantxa, do you want to address that?
Sure. What the panel is looking for is a best-in-class profile, which is what we are offering here: an 8-week regimen for the majority of patients. Once they see these results and, obviously, we obtain a label and an approval, I think it will not be difficult with this profile to get into treatment algorithms and to be prescribed by physicians. We are hearing excellent feedback from our principal investigators.
I just want to add one point: for both the North American trial and C-FORWARD, which enrolled in 17 countries, it is remarkable that we were able to fully enroll about 900 patients in less than eight months across 120 clinical sites, with very high demand. We actually had to stop because we could not go much beyond our targeted number of patients. There was really high demand for this clinical trial in both North America and those 17 countries. Next question, please.
Thank you. Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead.
Great. Thank you very much for taking my question, and congrats on the update. Regarding the non-inferiority, which also cleared on the per-protocol secondary in C-BEYOND, which is C-FORWARD's primary endpoint for the EMA, how much does that lift your confidence going into the early Q1 2027 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 one more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B, and how they are reshaping the competitive landscape. Thank you.
Sure. Great question. Arantxa, do you want to tackle that? We will report data at a scientific meeting. We are not overly worried about the per-protocol results, although discontinuations exist, we have sufficient power. Arantxa, please address the differences in patients and geographies.
Yes. Maxwell, that is a great question. For C-FORWARD, we are more likely to see genotypes that are not predominant in the U.S.; the U.S. is predominantly 1a, while ex-U.S. we will see more 1b and some of the rarer genotypes, such as 6 and 5, which we made an extraordinary effort to include. It will differ in terms of genotypes, but many of these genotypes were already treated in Phase 2, where we had excellent results, particularly for genotype 3. In terms of population behavior, we expect to see probably less transmission through IV drug use compared to the U.S. population. Globally, there is still transmission through routes like dental procedures, transplants, or blood transfusions. The ex-U.S. population tends to report fewer adverse events, tends to be less lost to follow-up, and tends to be a little more compliant with protocol. So if anything, we expect a more adherent population, perhaps closer to what we saw in Phase 2 where results were excellent. I think that addresses your main question.
Sure. Max, on pricing reforms and the impact of Medicare Part D, 340B, and related changes: it depends on the market segment. Currently, Mavyret and Epclusa have different percentages of business coming from Medicaid and Medicare, and those changes have already started to take effect. For instance, the Inflation Reduction Act has impacted Medicare dynamics in the past. Regarding reference pricing and MFN-type pricing effects on Medicaid, it could affect Medicaid discounts currently being offered. That said, when you compare U.S. pricing to many European or Western countries used in reference pricing, the pricing differential for DAAs is not as dramatic as for other pharmaceutical products, so the impact may be less than some expect. Also, some manufacturers already negotiate direct deals with individual state Medicaid agencies beyond statutory discounts. Regarding 340B, proposed legislative and administrative changes may be favorable to manufacturers if the mechanism shifts from an outright discounted price to a rebate mechanism, potentially avoiding double counting on both Medicaid and 340B. We will stay tuned to developments.
Thank you very much. I want to clarify one point for Maxwell: for C-FORWARD, the per-protocol core is the primary endpoint for the EMA, but for the FDA, the mITT is the primary endpoint. So please be aware that the mITT will be the primary endpoint for the FDA. Essentially, we will have two primary endpoints in C-FORWARD depending on the regulatory agency. I hope that clarifies it.
Thank you very much. Thank you for clarifying. Appreciate it.
Thanks. Okay. Very good. Thank you, Maxwell. And any other questions? So thank you all for joining our second quarter conference call, and thank you for your continued support.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.