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DATE

Thursday, March 5, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Jean-Pierre Sommadossi
  • Chief Medical Officer — Dr. Janet Hammond
  • Chief Development Officer — Dr. Arantxa Horga
  • Chief Commercial Officer — John F. Vavricka
  • Chief Financial Officer — Andrea J. Corcoran

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TAKEAWAYS

  • Cash and Investments -- $301.8 million as of December 31, 2025, sufficient to fully fund current Phase III HCV and new HEV programs through 2027.
  • Phase III HCV Trials -- C BEYOND enrollment completed in North America with over 880 patients; C FORWARD to complete enrollment outside North America by midyear, with top-line results expected midyear for C BEYOND and year-end for C FORWARD.
  • Clinical Trial Design -- Over 1,760 patients to be enrolled across two open-label, randomized Phase III HCV studies using separate primary endpoint populations per regional regulatory preference (MITT for FDA, per-protocol for EMA).
  • Phase II HCV Results -- Eight-week regimen achieved 98% SVR12 in the per-protocol population and 95% SVR12 in efficacy-evaluable group; confirmed high barrier to resistance and absence of dose adjustment for hepatic or renal impairment.
  • Product Profile -- Regimen demonstrated low risk of drug–drug interactions, including with proton pump inhibitors, H2 blockers, and HIV therapy, with no food effect restriction.
  • Commercial Strategy -- U.S. HCV prescriber base highly concentrated; approximately 6,000 providers write 80% of DAA prescriptions, enabling efficient commercialization through an expected 75-person sales force.
  • Market Research -- U.S. physicians surveyed indicated intent to prescribe the regimen to about half of their patients, regardless of cirrhosis status; payers responded favorably to potential formulary inclusion.[IQVIA Study]
  • HEV Program Progress -- Initiated IND- and CTA-enabling studies for AT-587 as lead HEV candidate; first-in-human trial anticipated midyear, with proof-of-concept by year-end.
  • HEV Market Opportunity -- Approximately 3% of 450,000 immunocompromised patients per year in U.S. and Europe at risk for chronic HEV, representing a $750 million-$1 billion annual revenue opportunity per company estimates.
  • Share Repurchase -- $25 million returned to stockholders during 2025 via buyback.
  • R&D Expenses -- Increased in 2025 due to higher external spend on HCV Phase III trials and HEV discovery; partially offset by lower expenses in discontinued COVID-19 development and reduced stock-based compensation.
  • G&A Expenses -- Decreased quarter over quarter and year over year, primarily from reduced stock-based compensation and lower payroll, partially offset by increased professional fees.
  • Licensing Agreement with Merck (NYSE:MRK) -- Milestone and royalty obligations tied to commercialization of rucasvir; next milestone contingent on NDA submission and approval targeted for 2027.
  • Regulatory Milestones -- NDA for HCV regimen submission planned contingent upon successful Phase III readouts.

SUMMARY

Atea Pharmaceuticals (AVIR +6.43%) advanced key clinical programs, completing North American Phase III patient enrollment for HCV and projecting global top-line results within this year. Management introduced a commercial strategy targeting the concentrated U.S. prescriber base, with market research indicating broad physician and payer receptivity to the HCV regimen. Expansion of the antiviral pipeline into chronic HEV, with first-in-human studies scheduled midyear, was highlighted as a potential new revenue driver addressing an unmet need in immunocompromised populations. Strategic use of $301.8 million cash achieved development milestones, supported a $25 million share repurchase, and extended operational runway to 2027 without financing risk based on stated guidance.

  • Management emphasized that both pivotal Phase III HCV trials are open-label, randomized, and structured for regulatory alignment with FDA and EMA requirements.
  • New data presented at recent conferences reinforced claims of a high barrier to resistance and robust antiviral activity for the lead HCV regimen.
  • Operational investments in 2025 were directed primarily at clinical execution, with non-core programs winding down; spending discipline will remain a priority through 2026.
  • The HEV program achieved selection of AT-587 as the lead compound due to favorable in vitro potency and preclinical safety, with plans for rapid clinical progression into 2027.

INDUSTRY GLOSSARY

  • SVR12: Sustained virologic response 12 weeks after completion of therapy, considered a cure marker in HCV trials.
  • MITT (Modified Intent-to-Treat): Analysis population including all randomized and dosed patients, regardless of adherence or follow-up, commonly used in FDA submissions.
  • Per-Protocol Population: Participants who meet predefined criteria for adherence and protocol compliance, typically preferred in EMA regulatory analysis.
  • DAA (Direct-Acting Antiviral): Class of drugs targeting viral replication mechanisms, used in treatment of hepatitis C.
  • IND: Investigational New Drug application filed with regulatory agencies prior to first-in-human clinical studies.
  • CTA: Clinical Trial Application for initiation of human studies in non-U.S. jurisdictions.
  • NDA: New Drug Application for requesting regulatory approval of a novel therapeutic with the FDA.
  • RAS (Resistance-Associated Substitution): Viral genetic mutations that confer decreased drug susceptibility.

Full Conference Call Transcript

Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on slide three. I am pleased to report that we have made substantial clinical progress in the last year advancing our global Phase III program evaluating the regimen of and rizatrizumab for the treatment of HCV infections. Due to the rigorous execution of our two pivotal Phase III trials, C BEYOND and C FORWARD, we expect top-line readout this year for both. We also presented several datasets reinforcing the potential best-in-class profile of our regimen at the EASO Congress in 2025 and The Liver Meeting 2025, the annual meeting of AASLD. Janet will discuss highlights from these presentations.

We convened two panel discussions with key opinion leaders that underscore the need for a new optimized HCV regimen to address treatment paradigm shift including the test-and-treat model of care, and how our regimen is uniquely positioned to address the current needs of patients and prescribers and expand the market in the U.S. In November, we announced the expansion of 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 available. If left untreated, it can rapidly progress to cirrhosis within three to five years.

In vitro and in vivo results, presented last month at quarter 2026 and at the J.P. Morgan Healthcare Conference in January, support our lead product candidate, 85-87, as a potential first-in-class inhibitor against HEV infection. I will review this exciting program later in the presentation. Moving to slide four, I am pleased to report that our global Phase III HCV program is on track. In December, we completed enrollment for our North American trial, C BEYOND, with over 880 patients, and we expect to complete enrollment for C FORWARD outside of North America by midyear. We anticipate top-line results for C BEYOND midyear and for C FORWARD by year-end.

Following our selection of 85-87 as the lead product candidate in our HEV program, we initiated IND and CTA-enabling studies and anticipate initiating a first-in-human study midyear. Importantly, with $301.8 million of cash, cash equivalents, and marketable securities as of 12/31/2025, 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 will extend to 2027. With that, I will now turn the call over to Janet to review the profile of our regimen.

Dr. Janet Hammond: Thanks, Jean-Pierre. Moving to slide six, hepatitis C remains a significant global healthcare crisis with an increasing incidence of infections. Despite the availability of direct-acting antivirals for the past decade, currently in the United States, out of the reported 160,000 new chronic infections, only 85,000 patients are treated annually. In 2015, there were approximately 2.5 million people infected in the United States. Today, that number has nearly doubled to approximately 4 million. The unrelenting high rate of new chronic hepatitis C infections, which continues to outpace the number of patients being treated, underscores the need for a new differentiated and optimized therapy.

In the map shown on the right, you can see that most countries worldwide, including the United States, are not on track to achieve the World Health Organization's goal of the elimination of hepatitis C by 2030. In fact, current estimates suggest we may not even achieve this goal by 2050. Let us not forget that hepatitis C is the primary cause of liver cancer in the United States, the incidence of which is projected to increase by over 50% within the next five years, from approximately 850,000 cases in 2025 to 1.4 million people.

On slide seven, we are conducting the first global head-to-head active-controlled Phase III trials in our program for hepatitis C, comparing our regimen against the current standard of care sofosbuvir and velpatasvir, which are marketed as Epclusa. Results support our regimen as a potential best-in-class treatment option for patients infected with HCV, with a differentiated profile featuring a highly potent combination with a short treatment duration, low risk for drug–drug interactions, and convenience with no food effect. We continue to build out our dataset, and recent results demonstrated a low risk for drug–drug interaction to proton pump inhibitors, which are taken by an estimated 35% of hepatitis C-infected patients. Moving to slide eight.

We have presented several datasets supporting the potential best-in-class profile of the regimen of benifrostivir and ruzovir last year at the EASO Congress and then at The Liver Meeting. Results from the Phase II study in 275 patients demonstrated the eight-week regimen of bembruzumab achieved 98% SVR12 in the per-protocol treatment-adherent population and a 95% SVR12 in the efficacy-evaluable population. Additional results demonstrated that the regimen has a high barrier to resistance. The regimen has a low risk for drug–drug interactions, including with proton pump inhibitors, H2 blockers, and also standard HIV therapy. There is no need for dose adjustment of benzosbuvir in patients with hepatic or renal impairment. The regimen can be taken with or without food.

In addition, recently generated data show that in addition to inhibiting HCV RNA replication through chain termination, benefactor there also inhibits assembly and secretion of new hepatitis C virions, further explaining its high antiviral potency. With that, I will now turn the call over to Arantxa to provide an update on our Phase III program for hepatitis C.

Dr. Arantxa Horga: Thank you, Janet. On slide 10, C BEYOND enrolled patients in the U.S. and Canada, and C FORWARD is enrolling patients in 17 countries outside of North America. Combined, we expect to enroll more than 1,760 patients in our Phase III program. Both trials are open-label, randomized one-to-one against the comparator, and stratified by cirrhosis status, genotype, and including patients coinfected with HIV. In patients without cirrhosis, treatment duration is eight weeks with benefosbuvir 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 11 shows the geographic footprint of our global Phase III program with approximately 120 clinical sites in the U.S. and Canada for C BEYOND and another 120 clinical sites in 17 countries outside of North America for C FORWARD. As Jean-Pierre mentioned earlier, C BEYOND patient enrollment was completed in December with more than 880 patients, and we anticipate top-line results midyear. C FORWARD has a broader global geographic and genotypic and we expect to complete enrollment midyear and to report top-line results by year-end. On slide 12, let us review the Phase III 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 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 include the SVR rate of 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 SVR assessment at week 24. A key secondary endpoint will include the SVR rate for a modified intent-to-treat population. The same method for assessing noninferiority will be conducted in both Phase III studies and both patient populations. The Phase III studies are powered 90% with a 5% noninferiority margin with expected rates approximating 95% in an MITT population.

Using these two approaches in a post hoc analysis of the Phase II results, the SVR rate was 95% in an MITT population and 98% 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. Moving on to slide 14. As discussed earlier in the call, the rate of newly reported HCV infection in the U.S. is outpacing treatment. Out of approximately 160,000 new HCV infections, only 85,000 patients are treated annually for a total of approximately $1.3 billion in net sales in the U.S. We have consistently heard from healthcare providers that the test-and-treat model of care, which allows for HCV testing, diagnosis, and treatment at the point of care, can reduce the barriers to prompt initiation of therapy that exist today. The test-and-treat model of care has gained broad support, including by the CDC, and continues to gain momentum through recent bipartisan efforts to advance HCV elimination in the U.S.

Key opinion leaders also assert it can play a critical role in HCV elimination efforts and agree that a treatment optimized to work seamlessly with this model is still needed. Slide 15. While we are advancing our global Phase III trials, we are also preparing for a commercial product launch. Our commercial package will include a blister card for convenience and adherence with a simple four-week dosing package. The drug product has a low cost of goods relative to net price, and based on our current projections, we are achieving profitability relatively shortly post-launch. From a commercial standpoint, the U.S.

HCV prescriber base is highly concentrated with approximately 6,000 prescribers writing 80% of the DAA prescriptions, making it optimal for efficient commercialization using a focused specialty sales force. We anticipate a commercial sales force of around 75 people, which includes the sales team and medical science liaisons. Let us move on to slide 16. Using our Phase II results, IQVIA conducted an independent quantitative market research study with 153 U.S. high prescribers. These physicians indicated that they would likely prescribe the VEM RZR regimen to approximately half of their patients, and the results were similar for all patients regardless of their cirrhosis status.

Our market research also showed that U.S. payers responded favorably about the potential to include Benmarzr in the formulary based on the regimen's profile. I will now hand the call back to Jean-Pierre to review the HEV program.

Jean-Pierre Sommadossi: Thank you, John. Let us now move to slide 18. The present is EVANS 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 and mostly causes epidemics of acute self-limiting viral hepatitis. In developed countries, genotype 3 is predominantly transmitted primarily through contaminated food such as undercooked meat. This can cause chronic hepatitis in immunocompromised patients and can progress to cirrhosis within three to five years, which is much far more aggressive than what you have seen with hepatitis C and hepatitis B. With no approved therapies for HEV, there is a significant unmet need for a treatment option.

Moving to slide 19. In recent years, with the increasing number of patients who are immunocompromised, which include solid organ transplant recipients, hematopoietic stem cell transplant recipients, patients with hematologic malignancies such as multiple myeloma, there has been a growing incidence of chronic HCV infection in the U.S. and Europe. In the absence of any approved therapies for HEV, the standard of care includes reducing immunosuppression and/or ribavirin administration, which both present challenges. On slide 20, each year in the U.S. and Europe, about 3% of approximately 450,000 patients who have these underlying medical conditions are at risk to develop chronic HEV.

We estimate that the unmet need for this patient population represents a market opportunity between $750 million to $1 billion per year. And obviously, this will follow on orphan designation. On slide 21, let us now review data supporting the selection of 85-87, our lead product candidate, a potential first-in-class direct-acting antiviral treatment option for chronic HEV. As you see on this slide, in vitro and in vivo activity of any positive review was shown against hepatitis E. However, the more potent in vitro activity of AT 5-8-7 combined with the positive PK data, which we will discuss next, led us to select 85-87 as the lead product candidate.

The in vitro data in this slide show the potent nanomolar antiviral activity of AT 5-8-7 against HEV genotype 3 and to remain also active against clinical ribavirin resistance-associated substitutions, or RAS. As noted earlier, ribavirin is off-label for the treatment; it is used off-label for the treatment of HEV. On slide 22, we observed that in the in vivo single-dose PK studies in rats and monkeys, 85-87 achieved high plasma concentrations of the active triphosphate metabolite sorghum, which were comparable to those obtained with benifolsomibir. On slide 23, of particular importance, we also demonstrated 8-8-7 efficiently converted to its active triphosphate in human hepatocytes, which is the site of viral replication in HCV infection.

To date, AT 5-8-7 has a clean preclinical safety profile, positioning this product candidate as a first-in-class direct-acting antiviral for chronic HEV. I would now turn the call over to Andrea to discuss our financials.

Andrea J. Corcoran: Thanks, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2025. The statement of operations and balance sheet are on slides 25 and 26. We are pleased to report that our cash and investments were $301.8 million at 12/31/2025. The funds expended in 2025 were principally directed to the advancement of our HCV Phase III program evaluating the combination regimen of benifosavir and rucifir and to discovery efforts leading to the nomination in January 2026 of AT 587 as the lead product candidate for the treatment of HEV. In 2025, we also returned $25 million to our stockholders through a share repurchase program.

Each of these investments and uses of funds reflects our steadfast commitment to drive value for our stockholders. For R&D expenses, quarter-over-quarter and year-over-year, there was an increase in 2025 compared to 2024. The net increase in 2025 was principally driven by an increase in external spend for HCV Phase III clinical development, offset by a decrease in 2025 in external spend for our COVID-19 clinical development and lower internal expenses primarily related to a decrease in stock-based compensation expense and lower payroll and payroll-related expenses. For G&A expenses, quarter-over-quarter and year-over-year, expenses decreased. The net decrease was primarily related to lower stock-based compensation expense, partially offset by increased professional fees.

For 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. As we complete our Phase III clinical trials, prepare to submit our regulatory filings, and engage in prelaunch activities, including the build of commercial launch supply, the substantial majority of our spending in 2026 will be focused on the advancement of our HCV program. With the resources in hand as of the end of the year, we expect to realize value-creating milestones for both programs and 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. On slide 27, in closing, 2026 will be a pivotal year for Atea Pharmaceuticals, Inc. We are on track to deliver top-line Phase III results from C BEYOND midyear. These results will be followed by the top-line results from C FORWARD by the end of this year. We believe that the target profile of our regimens, featuring high efficacy, short treatment duration, low risk of drug–drug interaction, and convenience with no food effect, will uniquely position us to address the needs of today's patients and seamlessly fit in the test-and-treat model of care, which has the potential to bring us closer to the ultimate goal of HCV elimination.

Our HEV program will present a strategic expansion of our antiviral pipeline and address a major unmet need in the highly vulnerable patient population for which there is no approved treatments available. We anticipate initiating a first-in-human study midyear with a proof of concept by the end of the year and possible advancement to a Phase II/III trial in 2027. With that, I will turn the call back over to the Operator.

Operator: Thank you. We will now begin the question-and-answer session. To ask a question, you may press star and then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. The first question will come from Maxwell Skor with Morgan Stanley. Please go ahead.

Maxwell Skor: Hello. This is Selena on for Max. Having achieved your enrollment target for the cirrhotic population for C BEYOND, does that increase your confidence in hitting your target in C FORWARD?

Dr. Arantxa Horga: I will say we are going to achieve our target overall for the program both in C BEYOND and in C FORWARD. The cirrhotic enrollment has not been an issue.

Maxwell Skor: Thank you.

Operator: The next question will come from Jonathan Miller with Evercore ISI. Please go ahead.

Jonathan Miller: As we look forward to a commercial launch in HCV, I guess I will focus there. Can you talk a little bit about how the commercial landscape is currently organized in terms of contracting? Are there centralized groups that you are going to have to convince to switch over from legacy systems? How is pricing in the commercial universe currently going to evolve as we have seen the legacy regimens get put under significant pricing pressure? So can you talk a little bit about how the commercial landscape has evolved over the past six to nine months? And how well you are positioned to deal with those changes?

Jean-Pierre Sommadossi: Great question, John. John?

John F. Vavricka: Sure. So as you know, the market for the distribution market for specialty for DAA, that is a specialty market, and there are three segments, pretty much commercial, Medicare, and Medicaid. All of those current distribution pathways are known and are fully utilized, and we are currently looking at all those relative to the three segments as well as relative to the payers. So it is a known quantity where we will have to be. We actually have conducted preliminary research with the payers, and obviously, the profile is of interest to them, and it was stated that they would be eager to include it in the formulary. As far as for pricing goes, the pricing is relatively stable.

Year over year, Maderyn pricing went up a little bit, but inclusive price pricing did, net pricing did go down. But overall, for the past at least two or three years, the pricing has been—the relative overall net pricing has been relatively stable. And their market shares are getting pretty close to 50/50 with the favoring Epclusa. Did I answer your question?

Jonathan Miller: Yes, it does. Thank you very much. I will get back in the queue. Thanks.

Operator: The next question will come from Andy Hsieh with William Blair. Please go ahead.

Andy Hsieh: Thanks for taking our question. So looking at the primary endpoint of C BEYOND based on the modified intent-to-treat population, am I thinking about this correctly that based on this analysis plan, you can actually really expand the effect size because you can basically magnify a regimen that actually can have flexibility into missing doses given the more potency profile compared to the standard of care? So that is part number one.

And part number two is, you know, in a scenario where you can actually show material clinical benefit over the standard of care, say maybe with a statistical perspective, Jean-Pierre, based on your market analysis, how would that change some of the physician response in terms of their excitement or potential market uptake? Thank you.

Jean-Pierre Sommadossi: Good question, Andy. Arantxa, do you want to try the first one?

Dr. Arantxa Horga: Yes, Andy, so the MITT, as you know, is everybody that gets a dose. You know? So there will be a range there from people that will get one dose or maybe five days of dosing to people who will be, you know, almost done with a full picture, so with all the doses. So I think it will be interesting to see how it pans out, you know, what is the minimum, I guess. But right now, we are really aiming for an eight-week regimen. We can do some analysis in the future.

Andy Hsieh: Jean-Pierre?

John F. Vavricka: Yes. We are actually very excited because when we look at the market research that has been done just with the Phase II data, bearing in mind that these physicians have 10 years’ experience with two DAAs, and showing them a profile which, as we talked about, you know, the short duration, low likelihood of drug–drug interactions, and the convenience of with or without food. You know, just seeing that profile the first time, they saw it being used in approximately 50% of their patients regardless of their cirrhosis status. So the profile right now stands very, very well.

So your question about if there was some kind of more favorable response in terms of Benmore ZR obviously would play into their likelihood to prescribe them or the OR. But we are also very conscious that we play in the specialty arena. And in that specialty arena, you know, obviously, the of market share tends to balance itself out to make sure that the market is preserved over time.

Jean-Pierre Sommadossi: Just to add, Andy, it is clear from the KOL and the prescriber that number one key important feature is the treatment duration. So treatment duration definitely will be the shortest with Marivat. But then after, when you evaluate all the, I would say, complex aspects with patients with polymedication, we feel that the prescriber will really highly favor our regimen. And then we will have to wait for the clinical data, you know, in terms of all the type of side effects with fatigue and nausea and headache that have been reported. So let us not forget that this is the first head-to-head.

There are a lot of real-world type studies, but as a controlled randomized clinical study, this is the first one, and let us see what we are going to learn.

Andy Hsieh: Great. And maybe a quick housekeeping item, just, you know, from an R&D perspective. Seems like there is a one-time Merck license agreement. Can you talk about that just so we have a better sense of, you know, kind of going forward what the—

Jean-Pierre Sommadossi: Okay. Sure. Andrea?

Andrea J. Corcoran: So yes, Andy. We have in-licensed rucasvir, which is the combination product with benifasvir in the HCV product candidate. We are paying milestones, and we will pay royalties to Merck on successful commercialization. The next milestone will be due when we submit the NDA and the NDA is approved. We believe that is in 2027.

Andy Hsieh: I see. That is helpful. Thank you.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Jean-Pierre Sommadossi for any closing remarks.

Jean-Pierre Sommadossi: Thank you all for joining our fourth quarter 2025 and full year earnings call, and thank you for your continued support.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.