Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q1 2026 Earnings Call Transcript

Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q1 2026 Earnings Call Transcript May 12, 2026

Atea Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $-0.57, expectations were $-0.6.

Operator: Ladies and gentlemen, thank you for standing by. Welcome to Atea Pharmaceuticals’ First Quarter 26 Earnings Conference Call. At this time, participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. I will now turn it over to Atea’s management team. Please go ahead.

Jonae R. Barnes: Hi, thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals first quarter 26 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 visiting the Investors section of our website at ir.ateapharma.com. With me today 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. Maria Arantxa Horga and Chief Financial Officer and Executive Vice President of legal, Andrea J. Corcoran, who will all 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.

Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. With 2 pivotal Phase 3 top line readouts for our global Phase III HCV program ahead of us. 2026 will be a catalyst rich year for Atea. We remain on track and are very encouraged by the substantial progress our team continues to achieve. We completed patient enrollment for CBR, our North American trial, late last year with over 880 patients who are representative of the genotypes and demographics in North America. For c 4, our ex North America trial, I am pleased to share today that we have completed enrollment for 95% of the cirrhotic and non cirrhotic patients. And anticipate completing enrollment next month as scheduled.

Currently, enrollment is only open to the less prevalent genotypes such as 4, 5, and 6. Which will allow us to support a broad label. This sets up 2 important Phase 3 milestones. We expect top line data from C-BEYOND mid-year as we have reported before and top line data from C-FORWARD around year-end. Late last year, we expanded our antiviral hepatitis pipeline to address a major unmet medical need for immunocompromised patients living with chronic hepatitis E infection. A liver disease for which there is currently no approved therapy. If left untreated, in this at risk population, it can rapidly progress to cirrhosis within only 3 to 5 years. We have completed CTA enabling studies for AT-587, our lead product candidate, And we anticipate initiating a first-in-human study mid-year.

Initial results were presented in February at COI 26 and additional data will be presented at EASL later this month to support AT-587 as a potential first in class inhibitor against hepatitis E infection. I will review this exciting program and our clinical plan for the first-in-human study later in this presentation. Importantly, with $256 million of cash equivalent and marketable securities as of March 31, 2026, we are in a strong financial position to execute and complete our Phase III HCV program and advance our new HEV development program. We anticipate our cash runway remaining through 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.

Janet J. Hammond: Thanks, Jean-Pierre. On slide 5, we are conducting the first active controlled phase 3 global program for hepatitis c. Comparing our regimen against the current standard of care the fostamivir and velpatasvir, which is marketed as Epclusa. The data generated to date for the regimen of benifrostavir and ruzavir supported differentiated potentially best in class profile, combining high efficacy short treatment duration with a low risk for drug interactions, dosing convenience, and no food effect. We continue to add to our dataset and recent results demonstrate a low risk for drug interaction with proton pump inhibitors which are taken by an estimated least 35 percent of hepatitis c patients. We have also confirmed the absence of an interaction with HMG-CoA reductase inhibitors or statins.

Another important and commonly prescribed class of medication. In closing, I am also pleased to share that we will be presenting additional results at EASL later this month that supports the potential for a best in class profile for our regimen. I am going to hand the call over now to Arancha to review our Phase 3 program for the treatment of hepatitis c. Arantxa?

Maria Arantxa Horga: Thank you, Janet. Moving to Slide 7, as a reminder, Beyond enrolled patients in the U.S. and Canada and SeeForward is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 77 patients in our Phase 3 program. Both trials are open label randomized 1 to 1 against the active comparator and stratified by cirrhosis status and genotype, including patients coinfected with HIV. In patients with a cirrhosis, treatment duration is 8 weeks with benefosbuvir/ruzasvir, and 12 weeks with the standard of care. Patients with compensated cirrhosis, receive 12 weeks of treatment with either regimen. The primary endpoint for both studies is sustained viral response or cure 24 weeks after treatment initiation.

Slide 8 shows that the geographic footprint of our global Phase III program was comprised of approximately 120 clinical sites in the U.S. and Canada for 120 clinical sites in 17 countries outside of North America for C-FORWARD. We completed patient enrollment of our C-BEYOND trial in December with more than 880 patients and we anticipate top-line results mid-year. SeaForward has a broader global geographic and genotypic footprint, and we expect to complete enrollment mid-year and to report top-line results around year-end. As J.P. mentioned earlier, we are pleased to share that for C-FORWARD, we have completed enrollment of 95% of the trial in cirrhotic and non cirrhotic patients. Enrollment is only open to the less frequent genotypes such as 4, 5, and 6.

Which will support a broad label. Enrollment of C-FORWARD remains on track to be completed by midyear. On Slide 9, let’s review the Phase 3 endpoints, patient population and data analysis for our global Phase III program. In C-BEYOND, the primary endpoint will be analyzed in a modified intent to treat or MITT population as preferred by the U.S. FDA. The analysis will include patients that have been randomized and dosed regardless of drug adherence or loss to follow-up. The statistical analysis will be based on an imputation model with success or failure depending on PCR value, whether negative or not, prior to patient treatment discontinuation. A key secondary endpoint will be the SBR rate in the per protocol population. In C-FORWARD, the per protocol population will be analyzed as the primary endpoint as preferred by the EMA.

And the SVR rate will only include patients who are at least 80% adherent as measured by pill count and have an SDR assessment at week 24. A key secondary endpoint will be the SDR rate in the MITT population. The same methods for assessing non inferiority will be conducted in both phase 3 studies and in both patient populations. The phase 3 studies are powered 90% with a 5% non-inferiority margin with expected rates about 95% in a modified intent to treat for MITT population. Using these 2 approaches in a post hoc analysis of the phase 2 results, the SBR rate was 95%. In MITT, we would issue percent in the per protocol population. I will now hand the call over to John Vavricka, our Chief Commercial Officer. John?

John F. Vavricka: Thank you, Arantxa. I will begin on Slide 11. HCV remains a significant global health care crisis, with an increasing incidence of infections despite the availability of direct-acting antivirals for the past decade. Currently in the U.S., out of a reported 160 thousand new chronic infections only approximately 85 thousand patients are treated annually. In The US, it is estimated that up to 4 million people are infected with HCV. The unrelenting high rate of new chronic HCV infections which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy. Most countries worldwide, including The US, are not on track to achieve the World Health Organization’s goal of HCV elimination by 2030.

In fact, current estimates suggest we may not even achieve this goal by 2050. HCV is also a leading driver of liver related morbidity in the U.S., including progression to cirrhosis and liver cancer, reinforcing the importance of expanding diagnosis and treatment. Moving to slide 12. U.S. HCV market remains substantial with approximately $1.3 billion in annual net sales, about 50% of the roughly $2.6 billion global market. Reflecting the size of the opportunity In our discussions with healthcare providers, we consistently hear that a point of care test and treat approach where testing, diagnosis, treatment initiation occur in a single setting can significantly reduce delays in care and minimize patient drop off before treatment begins. This model has broad support including from the CDC, and is gaining momentum through bipartisan efforts to achieve HCV elimination in The US.

Key opinion leaders believe it can be an important lever to help increase the number of patients treated and support HCV elimination efforts. And they continue to emphasize the need for therapy designed to integrate smoothly into this care pathway. Let’s turn to slide 13. This slide summarizes The US HCV payer mix and expected access dynamics. Medicaid represents just over half of DAA volume, with Medicare and commercial plans accounting for the balance. On the right, payer research shows a favorable outlook for parity access and parity net pricing across all 3 segments with meaningful concentrations of Medicare, Medicaid, and commercial payers indicating they would be very likely to add another option. Overall, these data support our view that BEM-RZR could achieve broad formulary inclusion subject to regulatory approval.

Slide 14. This slide highlights the competitive positions for The U.S. HCV market today. You can see that Epclusa and Mavyret drive value from different payer mixes. Epclusa skewing more heavily towards Medicare by Mavyret is concentrated in Medicaid. Let’s move to slide 15. Using our phase 2 results, IQVIA conducted an independent quantitative market research study with 153 U.S. high prescribers. These physicians indicated that they would likely prescribe BEM-RZR regimen to approximately half of their patients and the results were similar for all patients regardless of their cirrhosis state. On Slide 16, based on the U.S. HCV market dynamics, we believe we can be well positioned for a capital-efficient commercial launch. The prescriber base is highly concentrated, roughly 7.8 thousand physicians write about 80% of all DAA prescriptions.

We can reach the vast majority of the market with a specialty sales force of approximately 75. Including sales representatives, sales management, and medical science liaisons. With no other candidates in late stage clinical development, BEM-RZR enters the market primarily served by only 2 regimens. On the supply side, all components and processes for large-scale manufacturing are in place, and the commercial supply production is already underway, with a low cost of goods relative to expected net pricing. The 4-week dosing blister card packaging supports patient convenience and adherence. Taken together, we believe the concentrated prescriber base focused commercial infrastructure, and favorable manufacturing economics position us for a short time to profitability following NDA approval.

I will now hand the call back to Jean-Pierre to review the HEV program.

Jean-Pierre Sommadossi: Thank you, Jon. Let’s move to slide 18. Hepatitis E virus, or HEV, is an acute and chronic liver disease. In developing countries, Genotypes 1 and 2 are most prevalent and the virus is transmitted primarily through contaminated water leading to epidemics of acute self limiting viral hepatitis. In developed countries and mostly the U.S. and Europe, Genotype 3 is the most prevalent and is primarily transmitted through contaminated food such as undercooked meat. This genotype can cause chronic hepatitis in immunocompromised patients which can progress to cirrhosis within a short time of 3 to 5 years. And as you may know, this is far more aggressive than what occurs with hepatitis C or hepatitis B where it takes 15 to 20 years or even longer.

Moving to Slide 19, In recent years, with the increasing number of patients, who are immunocompromised, including solid organ transplant recipients, hematopoietic stem cell transplant recipients, as well as patients with hematologic malignancies, such as multiple myeloma, have been a growing incidence of chronic hepatitis E infection in the U.S. and Europe. Currently, the standard of care includes reducing immunosuppression, and or off label administration. Which both present challenges leading to a real opportunity for an effective direct antiviral drug. On Slide 20, each year, in the U.S. and Europe, 3% of approximately 450 thousand patients who have this underlying medical condition are at risk to develop chronic hepatitis E. The unmet need for this patient population potentially represents a market opportunity between $750 million to $1 billion each year.

On Slide 21, this slide highlights the preclinical data for AT-587. As a potential first in class direct acting antiviral for chronic hepatitis E. In the genotype 3 replicant in vitro model, AT-587 demonstrate the greatest potency and importantly, this anti viral activity has also been confirmed in primary human hepatocytes. The target organ for hepatitis E replications. In vitro data, also indicates low potential for drug interaction, which is important for this patient who for some, take lifelong therapies. On Slide 22, today, AT-587 has a clean in vitro and in vivo safety profile. CTA enabling GLP toxicology, and safety pharmacology studies are completed allowing us to advance to Phase 1 studies and positioning this product candidate as a first in class direct acting antiviral for chronic hepatitis E infections.

On Slide 23, The in vitro PK data in nonhuman primates and PBPK modeling we can predict that plasma exposure in humans will exceed the in vitro EC50 against hepatitis E replication in vitro, across the internal administration at pharmacologically relevant dosing. On slide 24, this slide outlines a synopsis of our first-in-human study for AT-587 The study will be conducted in healthy volunteers with the primary objectives of evaluating safety durability, and pharmacokinetics. it is a randomized double blind, placebo controlled design with sequential dose escalation and an embedded food-effect assessment. We have incorporated standard sentinel dosing and gated escalation with dose progression informed by real time safety and PK review. The study includes both single ascending and multiple ascending dose phases, providing flexibility to refine dose levels as data emerge.

I will now turn the call over to Andrea to discuss Atea’s financials.

Andrea J. Corcoran: Thank you, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the first quarter 26. The statement of operations and balance sheet are on Slide 26 and 27. We are pleased to report that our cash and investments were $256 million at 03/31/2026. The funds expended in the first quarter were principally directed to the advancement of our HCV program, evaluating the combination regimen of bemnifosbuvir and ruzasvir and to the advancement of the and completion of the CTA enabling studies and manufacture of clinical trial material for AT-587, our product candidate for the treatment of HEV. For R&D expenses, quarter over quarter, there was an increase in 2026 compared to 2025.

The net increase in 2026 was principally driven by an increase in external spend related to our HCV Phase III clinical development and HEV preclinical development. Offset by lower internal expenses primarily related to a decrease in stock based compensation and lower payroll and payroll related expenses. For G&A, quarter over quarter expenses decreased. The net decrease was primarily related to lower salaries and wages, lower stock based compensation expense, and lower professional fees. In 26, 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. As we complete our Phase III trials, prepare to submit our regulatory filings and engage in prelaunch activities including the manufacturing of commercial launch supply.

The substantial majority of our spending in 2026 will remain focused on the advancement of our hepatitis C program. With the resources in hand at the end of March, we expect to realize value creating milestones for both our hepatitis c and our hepatitis e programs and we project our cash runway to extend through 2027. I will now hand the call back to Jean-Pierre for closing remarks.

Jean-Pierre Sommadossi: Thank you, Andrea. In closing, 2026 is set to be a pivotal and value creating year for Atea. We remain on track to deliver top line Phase III results from C-BEYOND in mid-2026, followed by top line phase 3 results from C-FORWARD around year-end. We believe the target profile of our regimen high efficacy, short treatment duration, a low risk of drug interaction, and convenient dosing with no food effect position us to meaningfully address the needs of today’s patients and prescribers. We believe our regimen, fits seamlessly within the test and treat model of care which has the potential to expand the number of patients treated and accelerate progress toward the goal of HCV elimination in The United States and globally.

Our HEV program is a strategic expansion of our antiviral pipeline aim at addressing a major unmet need for highly vulnerable patient population. With no approval treatment options today. We anticipate initiating our first-in-human study mid-year followed by the initiation of a proof-of-concept study around year-end. With that, I would turn the call back to the operator.

Q&A Session

Operator: Thank you. At this time, we will be conducting a question and answer session. May be necessary to pick up your handset before pressing the star key. Our first question is from Jonathan Miller with Evercore.

Analyst (Jonathan Miller): Hi, guys. Thanks so much for taking my question. And looking forward to the upcoming data. Let’s start with that. I guess to what extent or what should we expect from the top line announcements for C-BEYOND and then later in the year for C-FORWARD? What sorts of data should we expect in a top line press release versus what would be withheld for later publication at a medical meeting or a peer reviewed setting. So. And then second, when we think about commercial launch cadence and potential there, Assuming the Phase 3s bear out the differentiated product profile, that you guys have been telling us about for a while, to what extent is commercial adoption going to be gated by contracting or by lumpy elements of getting your regimen in place in a program or a test-and-treat initiative that might have requirements on the drug it chooses.

Jean-Pierre Sommadossi: Thank you, Jon. Okay. Would address the first question. The first question we will release data with the C-BEYOND primary endpoint. And the key secondary efficacy endpoint. So the SVR at week 24 after initiate after initiation of treatment. In the modified intent-to-treat population, as well as the SVR at 24 in the per protocol population. John, you want to address the second part of the question?

John F. Vavricka: Sure. So, Jon, thank you for the question. So, currently, our launch preparation are currently underway, and that includes, the analysis and evaluation of the marketplace. And understanding currently the where the business segments are coming from, where likely future growth will be coming from, and also looking at where we will focus our activities. And that would be including across 3 segments. From a commercial perspective of payers in terms of who we want to target and what their formulary status is right now, and all those associated timelines, as well as preparations for Medicaid and Medicare areas. And the activities we will start executing them up upon the data of our phase 3 trials. And part of the question that you asked in terms of understanding what those timelines and so forth, will be evaluating all of that. As we put into our penetration segments for the market. Great. Thanks so much.

Jean-Pierre Sommadossi: Thank you.

Operator: Our next question is from Maxwell Skor with Morgan Stanley.

Analyst (Selena Zhang): Hello. This is Selena Zhang on for Maxwell Skor. Thanks for taking our question. With your market research based on Phase II results, what could you see in the Phase III that you would expect to impact prescriber or payer response? Should I–how go ahead. Hello? Oh, yes. So with your market research being primarily focused on, like, the phase 2 results, what could you see in the phase 3 results that you think might impact the prescriber or payer response?

Jean-Pierre Sommadossi: So I think we see things along the same, you know, trends that we found in Phase 2, which is great efficacy with low potential for drug interaction, no food effect, etcetera. So data from Phase 2, which is what we see always in infectious diseases, the phase 2 data translates very well into phase 3. I do not know if John wants to add something to this.

John F. Vavricka: No. I think I am fine. You know, obviously, we used the phase 2 data and that data was very well received. And the only thing I will tell you is that the payers and other others are also very much interested in having a head to head trial because it is the first time. And it was something that is very intriguing and important to them as well. It plays into the previous question about being ready for launch readiness, and 1 of those factors when you talk to the payers also is the head to head trial is very helpful to them.

Jean-Pierre Sommadossi: Thank you.

Operator: Our next question comes from Andy Hsieh with William Blair.

Analyst (Andy Hsieh): First 1, it has to do with C-BEYOND. So looking at the modified intended-to-treat population analysis plan, think you basically calculated a SVR 12 of 95%. Based on the phase 2 study. Looking across the landscape I believe Gilead published some of the noncompliant SER 12 rates before, and it is in the low nineties depending on the trials that you are looking at. So I am curious about your thinking in terms of a superiority claim based on that delta, So just maybe, coming out coming out of the powering and sample size to see, you know, what level of confidence you have to achieve that milestone. Second question has to do with AT-587. You mentioned about the first in human study and the design. I guess 2 parts. 1 is for this first in human study, what is the treatment duration that you intend to test? And then, I guess, in the real world setting, what do you expect the treatment duration to be? Thank you.

Jean-Pierre Sommadossi: And it is a great question. First, look. Our goal is to have a regimen delivered to patients and prescribers with the attributes that we have and we continue to demonstrate through clinical trials and nonclinical studies as well. Clinical pharmacology studies as well. And so our goal is a non inferiority trial, As you know, within a 5% margin. When we talk about the real world including the true intent to treat. You are right. it is around 90%. for Epclusa. If we take the same value in our phase 2, we were about the same. As the true intent-to-treat. As you know. So look. Let’s see. We do not want to speculate what it is going to be. We are going to actually evaluate. We think we have sufficient power definitely for the noninferiorities target.

And we will see the superiority probably with the 2 trials. Because that we will increase even the power when we combine the trial. And there is actually an analysis that it is planned and that has been shared with the FDA. Combining those 2 study and evaluated for potential superiority. For the for the AT 7, it is a good question. First, and then on phase 1, it is going to be–the MAD is going to be a 7-day. As standard phase 1. As we did with older indications. For the treatment duration, we foresee that we will start the proof of concept which we believe we should be able to initiate by year end. With a 12-week treatment duration. We are of the chronic tox toxicology studies ongoing. Right now. And we will have a PR for 3 months sometimes in the fall.

So definitely on time, to open a CTA on the proof of concept. We will solve very likely based on the phase 1 data that we will generate Probably as you have seen now from what we predicted, 600 milligram is a potential dose. QD or BID, we will see. And that would be a 12-week. Now we will, upfront, continue these chronic toxicology status up to 6 months in rat and 9 months in monkey. Because potentially, we will see. If we do not see a high SVR rate, With 12 weeks, we can potentially move to 24 weeks. Treatment duration is not an issue. In this patient population, as you know, they take lifelong treatment against organ rejection. So compliance should be very good. And we from what we have seen so far safety from a preclinical standpoint. have been good.

And we can have quite the flexibility in the phase 1 as I have just indicated. Related to a QD or BID regimen whether 12 weeks or 24 weeks. that is very helpful. Thank you.

Operator: Thank you. We have reached the end of the question and answer session. I would like to turn the call back to Jean-Pierre Sommadossi for closing remarks.

Jean-Pierre Sommadossi: Thank you all for joining our first quarter 26 earnings conference call. And thank you for your continued support.

Operator: Thank you. This concludes today’s conference. You may disconnect your lines at this time. Have a wonderful day.