Atea Pharmaceuticals (NASDAQ:AVIR) Q2 2026 Earnings Call

0:00 Good afternoon, everyone, and welcome to the Atea Pharmaceuticals second quarter twenty twenty six 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 up for your questions. I would now like to turn the call over to Jonay 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 twenty twenty six financial results and business update conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our website at ir.ateapharma.com.

0:51 With me from Atea are chief executive officer and founder, doctor Jean Pierre Samadosi chief development officer, doctor Janet Hammond chief commercial officer, John Vavrika chief medical officer, doctor Arancho Horga Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, who will be available for the Q and A portion of today's call. Before we begin the call and as outlined on slide two, 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'll now turn the call over to Jean Pierre.

1:39 Thank you, Jeanne. Good afternoon, everyone, and thank you for joining us. I will begin on Slide three. The positive top line results from CBEYOND, our phase three trial evaluating the combination of bemlizumab 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, we need a shorter, simple path to cure. We were very pleased that CBIng met both its primary and secondary endpoints with BamRussaVir demonstrating statistical non inferiority to Epclusa, the current standard of care.

2:28 Importantly, this was the first successful phase three trial in the global head to head HCV program achieved in the real world patient population that was poorly medicated, psychiatrically complex, substance abuse affected, and other ones challenge. These results reinforce the need for best in class profile designed for the broad and complex hepatitis C population clinicians treat today. Irenso will review in details the results of the trial.

3:16 Seafoam, our second phase three trial being conducted outside North America is fully enrolled with more than eight eighty patients. And we remain on track to report top line results in early Q1 twenty twenty seven. We believe that the C4WD dataset will provide important complimentary efficacy data across a broader range of genotypes and strengthen the pan genotypic regulatory package for Benelux Israel. In July, we also initiated our first in human Phase one clinical trial of AT-five eighty seven, our potential first in class direct acting antiviral for chronic hepatitis E, a serious disease with no approved therapy today.

4:22 This milestone reflects the continued advancement of our all direct acting antiviral pipeline. We remain in the solid financial position with $219,500,000 in cash and marketable securities as of 06/30/2026, with our cash runway anticipated through 2027. I will now hand the call over to Aranza, our Chief Medical Officer to review our Phase III program. Thank you, Jantir, and good afternoon, everyone. Moving to slide five, SP BEYOND was a randomized, active controlled non inferiority trial against sofosbuvirvelpatasvir marketed as Eclusa, a standard of care regimen.

5:18 The trial enrolled patients with chronic HCV at approximately a 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 benrussavir for eight weeks or Sofvell for twelve weeks. Patients with compensated cirrhosis receive twelve weeks of treatment with either regimen. On slide six, let's now review the CBEYOND 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.

6:11 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 ninety percent with a five percent non inferiority margin. See beyond is the anchor trial for The US NDA submission. Moving to slide seven, you can see that the baseline characteristics of the patients in See 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 eight, see Beyond enrolled the HCV population clinicians are treating in North America today, which looks meaningfully different from the population studied a decade ago.

7:09 In our trial, more than half of the patients reported injection drug use as the route of HCV transmission. Approximately eighty nine percent were taking concomitant medications, two thirds had a psychiatric disorder, and over ten percent 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 protein inhibitor containing regimen carries DBI limitations that restrict or complicate use in many of these patients while Iclusa requires twelve weeks of treatment.

7:54 In our market research, only six percent of a 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. Let's now review the phase three results on slide nine. In the primary endpoint MITT population, bemrusevir achieved a ninety three point nine percent SVR rate compared with ninety four point eight percent for soft bell at week 24, encompassing SVR twelve, the accepted definition of cure for HCV.

8:42 These results met the primary endpoint of statistical non inferiority within the prespecified five percent margin. Benrut Severe delivered cure rates comparable to the standard of care while offering an eight week regimen for noncerebotic patients compared to twelve weeks for soft pill. On slide 10, in the noncerobic MIPT population, bemroozasir achieved a ninety three point five percent SVR rate with eight weeks of treatment compared with ninety four point six percent for Sovel with twelve weeks of treatment. In patients with compensated cirrhosis, both arms achieved a ninety five point four percent FVR rate with twelve weeks of treatment.

9:33 Patients of populations 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 Benelux of the arm, three deaths in the Sopel arm were observed, but not related to the study drug. Similarly, there were no early treatment discontinuations related to to the study drugs. 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 SDR rates with approved therapies can fall below the rates reported ten years ago in the original pivotal studies.

10:38 Indeed, as you can see more recent studies, the intent to treat as the rate fall below the rates reflected in labels established a decade ago, including rates as low as seventy four percent among people who injected drugs with rates consistently in the low nineties. Slide 13 summarizes the top line results for Sleep Beyond. The trial met its primary and secondary endpoint with bembrusavir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotypes. Biological failure rates were low and comparable across treatment arms.

11:23 Beneluxavir was generally safe and well tolerated with a safety profile comparable to soft belly. On slide 14 is the patient populations and analysis for C FORWARD, our second phase three trial, being conducted outside of North America to enable a broad pan genotypic label. It is fully enrolled and enriched for genotypes one b, three, four, five, and six using the same non inferiority methodology and the same powering assumptions. Together, the two phase three studies will form a comprehensive global data package for regulators worldwide. I will now hand the call over to Janet, our chief development officer.

12:13 Thank you, Arantia. Good afternoon, everyone. Moving on to slide 16, bemiruzovir is a next generation, pan genotypic, once daily, six dose regimen. Enifosbuvir is the most potent nucleotide we are aware of, being approximately tenfold more active than tofosbuvir in vitro, and ruzesvir is a picomolar potency, pangenotypic NS5A inhibitor. Together they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared with Epclusa and AVIRUS, remiruzavir 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 effect.

13:07 That combination is what defines a potential best in class profile. On slide 17, the drug drug interaction profile is a key differentiator for bembruzir. Roughly eighty to ninety percent 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, bemruzasvir is expected to be broadly compatible where competitors carry contraindications or require dose modifications.

13:55 Fewer drug interactions strictly means 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 bemiruzovir, we believe our regimen is well positioned to address these barriers and expand the number of patients successfully treated. I'll now turn the call over to John Vavrica, 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 HCV market.

14:41 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 fifty percent of those new infected patients were treated. The result is a growing HCV infected population moving towards four 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.

15:33 This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in The United States. We believe our regimens 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 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 strengths of VAMRZR. 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.

16:27 In addition, there is a market growth potential with a simplified therapy and a focused commercialization. Moving on to slide 21. Our market research supports strong uptake of BemrZR. Among high volume DAA prescribers, seventy six percent said they would be extremely likely to prescribe BEMRZR. And the research predicts roughly half of both non cirrhotic and compensated cirrhotic patients would receive BEMRZR relative to occlusive MAVIRET. On slide 22, we believe bemRZR 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 seventy five thousand untreated new infections last year on top of the already large prevalent pool of patients.

17:21 In 2025, US net sales were $1,300,000,000 representing 50% of the global net sales of $2,600,000,000 With its differentiated profile, FAM RZR is uniquely positioned to expand the market potentially up to $2,500,000,000 annually in The United States. Slide 23. Taken together, we see peak annual US net revenue potential in excess of 700,000,000. That's anchored on a widening gap between infections and cures up to four 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 VA regimens.

18:09 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. 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.

18:59 We believe these factors position us for a short time to profitability following a launch. I'll now turn the call back to Janet to review the hepatitis B program. Thank you, John. On slide 26, In July, we initiated our first in human Phase I clinical trial of AT587. The study is being conducted in healthy volunteers with the primary objectives of evaluating safety, tolerability, and chronic 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 and with dose progression informed by real time safety and PK review.

19:52 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'm going to turn the call over now to Andrea Cochrane, our Chief Financial Officer, to discuss Atea's financials. Thanks, Janet. As Jornay mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of twenty twenty six. The statement of operations and balance sheet can be found on slides twenty eight and twenty nine. We are pleased to report that our cash and investments balance was 219,500,000 at 06/30/2026.

20:40 The funds we extended in the second quarter were principally directed to the advancement of our HCV phase three clinical trials, CBEYOND and C FORWARD, and to a lesser extent to the completion of clinical trial startup activities for the first in human study of AT587, which Janet just described is 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 SEEP Beyond, the completion of patient enrollment in SEEP Forward, and the initiation of the first in human clinical study of AT-five twenty seven. In the first six months of 2026, our R and 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.

21:41 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 and A, there was a decrease in the first six months of twenty twenty six 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 twenty twenty six, we intend to maintain our rigorous financial discipline while remaining laser focused on execution and value creating advancement of our HCV 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.

22:35 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'll 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 twenty twenty seven. Pending positive results from C FORWARD, our NDA submission is anticipated in the second quarter of twenty twenty seven.

23:32 Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. We're experiencing a technical difficulty. Hello? Thank you. JT, you may continue.

25:20 My apologies. I was discontinue disconnected. So in parallel, our hepatitis e program is progressing very well and advancing toward proof of concept in 2027. We believe that BAM results view 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 projection, we expect a short time to profitability after the anticipated mid-twenty twenty eight 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.

26:11 Thank you. We will now be conducting a question and answer star two 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 star 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. My first question has to do with labeling. 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?

27:12 That's number one. Number two, it has to do with the test and treat model. I think John you mentioned about that. He also mentioned about the one month blister pack. Based on some of the conversations with KOL, they really like to see 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? Thank you so much. Okay. First, Andy, thanks for, you know, scientific knowledge here. 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.

28:10 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 with the impact that we believe that this supplemental important MOA for them and totally unique. John, you want to address the second question of Andy? Sure. Thanks, Andy. Yeah, 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 then you are correct that the way that they would like to practice it is the patient is diagnosed and then immediately treated. This is unlike just like the other products that are out there. So we will have both bottles and for these lifter packs. And similar to the other products you would, you know, if it's you would have to likely for, you know, give, you know, 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 these 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.

29:34 Does that answer your question, Andy? Yeah. So I guess the question also has to do with kind of refilling requirements. So after the first month, you know, based on payers or other stakeholders, how basically, how do you eliminate that to or step to get a refill? 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, 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.

30:21 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? That's part of the challenges of 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. Great, thanks so much.

31:15 Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead. Hello. This is Xueyuan on for John. Thanks for taking my question and congrats again on the Phase III data. 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 CBEYOND and see forward results to include them in the treatment algorithm? Thank you. Loretta, you want to address that? Sure. I think what they are looking for is best in class profile. So this is what we are offering here. It's the, eight week for the majority of the patients.

32:08 And, you know, 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 PI. Okay. Thank you. I think I just want to add one point is that for both the North American trial and the, C4 also in 17 countries, it's it's absolutely remarkable that we were able to fully enroll, about 900 patients, in less than eight months.

32:56 So, with 120 clinical sites, with a high demand. And we can 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 term of the number of targeted patients. But there was really a high demand, for, this clinical trial in both North America, The U. S, as well as in these 17 countries. Question, Thank you. Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead.

33:42 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 and c beyond, which is the c forwards primary endpoint for the EMA. How much does that lift your confidence going into the early 1Q27 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. Thank you. Sure, Brian. Great question. Irensen, you want to tackle?

34:30 We are going to basically report that at scientific meeting, but we do not worry. Obviously, we always worry, but we do not worry on on the per protocol. As you have seen, it's quite a bit of discontinuation, but, we have sufficient power. So Owen, don't I'll answer you chime in as well and and, address the difference of patients, which actually, it is substantial. I'll answer. Can you go ahead? Yes. I think, Max, 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.

35:20 So The United States predominantly is one a. Ex US, we're gonna be seeing more of the one b's, And then some of the rare genotypes that we made an extraordinary effort to get, genotypes six, five, which are not common in The United States. And so it will it will differ in terms of genotypes, but I wanna remind you that a lot of these genotypes we already treated in phase two, where we had, genotype three 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 two because globally, there is still quite a lot of transmission through things like dental procedures, transplants, even blood transfusions.

36:13 And the population ex US in general tends to report less frequently adverse events. They tend to be less lost to follow-up. They tend to be a little more compliant with the protocol. So if anything, we think we're gonna be seeing a more adherent population, and maybe even a little bit closer to what we saw in the phase two, where we had already excellent results. I think that was your, main question for me. There was another one, though. Oh, yes. I'm sorry. About pricing for John? Sure. So Max, I think your question was on pricing reform and the various, you know, generous and other legislative three forty b's reshaping the landscape. And you are correct. And it depends on, you know, what segment that you're more heavily weighted in. And currently, the two products, whether it's MAVIRET or APCLUSA, have different percentages of their business coming from Medicaid or Medicare.

37:11 And those changes have already started to take into effect. So for instance, having a higher percentage of Medicare patients, Inflation Reduction Act has had an effect on that. In the past, manufacturers weren't responsible for a percentage of total prescription cost there and that is happening now. As far as the other things you mentioned like generous and so forth, which is, you know, MFN type pricing and its effect on Medicaid, You know, it could affect the Medicaid discounts, but that are currently being offered. 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 generous 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. 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.

38:23 And so from that standpoint, the difference between the extra rebates that they're already providing and what this the generous or the extra rebates for MFN might be, which could theoretically be smaller. But that's what we know now. 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 manufacturers in the sense that 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.

39:11 But so we'll have to stay tuned to see what happens with that. Thanks, John. Want to go back. I want to go back just to make sure that there is no misunderstanding here. On the C4, purple core 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 CBION for C FORWARD, the primary endpoint for the for the FDA will be the MITT. So essentially, we will have two primary endpoints in the c forwards. I hope that Okay. Just to make sure Very helpful. That Thank you for thank you for clarifying. Appreciate it. Thanks. Okay. Very good.

40:00 Thank you, Max. 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.