Atea Pharmaceuticals Third Quarter 2026 Financial Results Conference Call - ATEA PHARMACEUTICALS INC

Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Third Quarter 2026 Financial Results and Business Update Conference Call. At this time, all participants are in a listening mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Joneigh Barnes, Senior Vice President of Investor Relations and Corporate Communications at Ateia PharmaceuticalS. Ms. Barnes, please proceed. Good afternoon, everyone, and welcome to Atea Pharmaceutical's third 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'll be reviewing today by going to the Investors section of our website at ir.ateapharma.com. With me today from Ateia are our Chief Executive Officer and Founder, Dr. Jean-Pierre Somadosi, Chief Development Officer, Dr. Janet Hammond, Chief Commercial Officer, John Vavrica, Chief Medical Officer, Doctor Aran Shahurga, and Chief Financial Officer and Executive Vice President of Legal, Andrea 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 two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk 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. Thank you, Janaye. Good afternoon, everyone, and thank you for joining us. I will begin on slide three. During the third quarter, we made significant progress across our pipeline setting the stage for a milestone rich 2027. with positive phase three results of our north american trial for the treatment of hcv and the rapid clinical advancement of our phase one hev program we are well positioned to deliver on our commitment to advance potential best-in-class or first-in class therapies that address the need of people worldwide living with serious viral diseases cbr our phase three trial evaluating the bam versus v regiment for the treatment of hcv in north america delivered strong results meeting its primary and secondary end points which of course is a major milestone for a tape and events i will review the results of the trial in more detail. We are on track to report top-line results in early 2027 for C-Forward, which is our global trial that enrolled patients in 17 countries. The results are expected to confirm the efficacy of BAM Resesvir across a broad range of HCV genotypes. Pending This result together with CBR are expected to support new drug application submission targeted for mid-2027 with the U.S. FDA. During the quarter, we also initiated a phase one clinical trial in the HAL-C subject for 8587 a potential first-in-class direct acting antiviral for chronic hev a serious disease for immunocompromised patients i'm pleased to report that the single ascending dose portion has been completed and we are progressing in the multiple ascending those portions we anticipate advancing 85 87 into a pro for concept study in the first half of 2027 which preliminary result targeted for late 2027. we remain in a very solid financial position with 191 million point two in cash and marketable securities for september 30th 2026. as announced today we have entered into a credit facility agreement with a QLIS capital for up to $200 million, drawing down $65 million at closet. The stage financing structure allows us to access capital and strengthen our flexibility in building commercialization robustness as we advance toward the anticipated u.s launch of bamboozles via in 2028 and andrea will review the details of this new transaction moving to slide four i will program a bust of first-in-class potential and we have now the financial runway to fund them through the major milestones delayed in this slide. Starting with HCV, BEM-RISS-SV, a potential best-in-class profile combines high cure rates with short treatment durations, lower risk of drug-drug interaction, and no food effect. The HCV market remains substantial. In 2025, global net sales were approximately $2.6 billion, including roughly $1.3 billion in the United States. For the Ben Rizzo's regimen, we see peak U.S. net sales potential of more than $700 million. Turning to HEV, 85H7 is a potential first-in-class direct acting in T-RAL. In an at-risk patient population, HEV can lead to chronic infection, cirrhosis, liver failure, or dust. And there are no FDA-approved treatments. We estimate a commercial opportunity between $1 and $1.5 billion per year in patients with HCV in the United States and Europe. I will now end the call over to Arant Sahoga, our Chief Medical Officer, to review our Phase 3 program. Thank you, Jean-Pierre. Good afternoon, everyone. Moving to slide six, CB-YOUND was a randomized, active-controlled, non-inferiority trial against a phosphoviral batavir marketed as EPCLUSA, a standard-of-care regimen. The trial enrolled patients with chronic HCV at approximately 120 clinical sites in the U.S. and Canada, including patients co-infected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received Ben-Rusavir for eight weeks or Sofvel for 12 weeks. Patience with compensated cirrhoses received 12 weeks of treatment with either regimen. Slide 7 outlines the CB-Young endpoints and patient populations. The primary efficacy endpoint is sustained viral response, or SVR, at week 24, in the modified intent-to-treat, or MITT, population, as agreed with the FDA. This population includes all patients who received at least one dose of the regimen, including those who discontinued early, were not compliant, or were lost to follow-up. The trial is powered at 90%, with a 5% non-inferiority margin. C-Beyond is the anchor trial for the U.S. NDA submission. Moving to slide eight, 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 9, C.B. Young enrolled a population representative of HCV patients being treated in North America today. Please note that this population is meaningfully different from the population enrolled in clinical trials a decade ago. In our trial, more than half of the patients reported injection drug use as the root of HCV transmission. 89% were taking concomitant medications, two-thirds had psychiatric disorders, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adhering to the protocol. Let's now review the Phase 3 results on Slide 10. In the primary endpoint MITT population, Ben Rusevier achieved a 94% SBR rate compared with 95% force of VEL at week 24, encompassing SVR12, the accepted definition of cure for HCV. These results met the primary endpoint of statistical non-inferiority within the pre-specified 5% margin. BEM-Rusosvir delivered cure rates comparable to the standard of care while offering an eight-week regimen for non-cirrhotic patients, which represent the majority of the patients in North America, compared to 12 weeks of soft bell. On slide 11, in the non-cirrhotic MITT population, Ben-Rusavir achieved a 94% SBR rate with eight weeks of treatment, compared with 95% for soft bell with 12 weeks or treatment. In patients with compensated cirrhosis, both arms achieved a 95% SBR rate with 12 weeks of treatment. Patients and populations are not powered for statistical analysis. On slide 12 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 the treatment arms There were no serious adverse events due to the study drugs. During the treatment emergent safety observation, treatment emergent adverse events resulted in death occurred in no patients receiving Ben-Rusavir and in three patients receiving Sovel. None of these events were related to the study drug. There were no early treatment discontinuations related to this study drug slide. Slide 13 outlines the patient population and analysis for C-Forward, our second Phase III trial being conducted outside of North America to support a broad pan-genotypic label. Building on the positive Phase III results from C-Beyond, we are looking forward to this next important readout in early 2027 and the opportunity to further demonstrate Ben-Russevier potential across a broader range of HCV genotypes. C-Forward enrolled more diverse genotypes, 1B, 3, 4, 5, and 6, and uses the same non-inferiority methodology, empowering assumptions as see beyond. Together, we expect the two Phase 3 studies will form a comprehensive global data package for regulators worldwide. I will now hand over the call to Janet Hammond, our Chief Development Officer. Thank you, Arantia. Good afternoon, everyone. Moving on to slide 15, BEM-Rusesvier is a once-daily, fixed-dose regimen. Benifosavir is a highly potent HCV nucleotide, and Rusesvir is a high-potent NS5A inhibitor. Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared with Hapusa and Maveritt, BEP-Rusersvier is the only regimen positioned to offer the full combination of short eight-week treatment duration for non-cirrhotic patients, protease inhibitor-free composition, a low potential for drug-drug interactions, and no food effect. That combination is what we believe defines potential best-in-class profile. On slide 16, the drug-Drug Interaction Profile is an important differentiator for BEM-RZR. Roughly 80% to 90% of HCV patients in the U.S. take concomitant medications and prescribers strongly prefer therapies that are simple to prescribe. Of course, oral contraceptives, protease inhibitors, and integrase inhibitor in HIV regimens, BASF, immunosuppressants, digoxin, and proton pump inhibitors as well as other acid-reducing therapies, BEM-RVR is expected to be broadly compatible where competitors carry contraindications or require dose modification. Fewer drug interactions can mean fewer specialist referrals, fewer treatment delays, and more patients actually starting and completing therapy. Recently, we completed a Phase I study evaluating BEM users there with methadone or suboxone to commonly used treatments for opioid use disorder. The study demonstrated a lack of drug-drug interactions, while co-administration was generally well-tolerated from healthy volunteers. These data further support the potential applicability of BEM-reduvere across a broad range of HCV patients encountered in real-world clinical practice. We plan on presenting the results at an upcoming scientific meeting. Today's treatment challenge is not just about efficacy. It is also about treatment duration, adherence, drug interactions, and access. Based on the potential profile of BMR-ZR, we believe our regimen is well positioned to address these barriers and has the potential to expand the number of patients who could be successfully treated. I'm going to turn the call over to John Zavrica, our Chief Commercial Officer. Thank you, Janet. Let's move now to slide 18. I want to address what we believe is a widely misunderstood dynamic in the HCV market. Wall Street often looks at revenue trends for approved HCV therapies and concludes that this is a declining market. The prevalence and treatment data tell a different story. Newly diagnosed patients with HCV infections continues to outpace patients treated annually. That gap is widening. In 2025, only around 50% of patients diagnosed that year were treated. The result is a growing HCV-infected population, moving towards 4 million people in the United States, which is an expanding, addressable market. As the adoption of test-and-treat model care continues to expand, it will help to serve as a critical lever to close the gap of untreated patients. Test-and treat enables seamless, rapid diagnosis and treatment initiation at the same point of care visit. This reduces barriers for prescribers and patient attrition even before treatment begins. This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in the United States. We believe that our regimen's profile is optimal for this model of care. Let's move on to slide 19. Our market research supports strong uptake of Benmar ZR. Among high-volume GDA prescribers, 76% said they would be extremely likely to prescribe BEM-RZR, and the research predicts roughly half of both non-thoracic and compensated thoracic patients would receive BEM RZR relative to a blue-set Mavurad. On slide 20, we believe BEM rZR is uniquely positioned to capture untreated patients and grow the market, not just simply compete for a listing share. Currently, only about half of diagnosed patients in the U.S. are treated annually, leading roughly 75,000 untreated diagnosed new infections last year, on top of the already large prevalent pool of patients. In 2025, HCV U.s. net sales were $1.3 billion, representing 50% of global net sales of $2.6 billion. With its differentiated profile, Ben Marziar is uniquely positioned to expand the market, which is potentially $2.5 billion annually in the U.S. On slide 21, taken together, we see peak annual U.F. net sales revenue potential in excess of $700 million. That potential is anchored in the widening gap between infections and cures and a total addressable market of up to 4 million infected in the U.S., with the number of untreated people increasing. Pricing is expected to be in line with existing branded DAA regimens. In closing on slide 22, 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 of the AA prescriptions in the U.S. We can reach the vast majority of this market with a focused specialty sales force of 75 to 100, including sales representatives, sales management, and medical science liaisons. All components and processes for large-scale manufacturing are in place. Commercial launch supplies is already underway with a low cost of goods relative to expected net pricing. And our four-week dosing booster packaging supports patient convenience and adherence. I'll now hand the call back to Janet to review the HEV program. Thank you, John. On slide 24, in July, we initiated our phase one clinical trial of AC587. 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. I'm pleased to report that we have successfully completed the single ascended dose portion of the study, and we are now progressing in the multiple ascended-dose curveball. As phase one development advances, we're also preparing for the initiation of a proof-of-concept study in the first half of 2027, with preliminary results anticipated in late 2027. Moving to slide 25. In recent years, there has been a growing incidence of chronic HEV infections in the U.S. and in Europe in immunocompromised patients. This is being driven by a combination of a growing vulnerable population, high susceptibility to chronic viral replication, distinct routes of transmission, and improves medical awareness. These patients include solid organ transplant recipients, hematopoietic stem cell transplant recipients, and patients with hematologic malignancies, such as multiple myeloma. Currently, the standard of care includes reducing immunosuppression and or off-label ribovirin administration, which both present challenges leading to a real opportunity for an effect with direct-acting antiviral with the goal of developing a cure for HEV. There are currently no FDA-approved treatments for HEB. On slide 26, each year in the U.S. and Europe, 3% of the approximately 545,000 patients who have these underlying medical conditions are at risk for developing chronic hepatitis E. The unmet need for this patient population potentially represents a market opportunity between $1 and $1.5 billion a year. AT587 is being developed to address chronic HEV in immunocompromised patients. It is a potential first-in-class direct-acting antiviral that provides a meaningful pipeline program beyond HCV. I'll now turn the call over to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials. Thank you, Janet. As Joneigh mentioned in her introductory remarks, Earlier today, we issued a press release containing our financial results for the third quarter of 2026. The Statement of Operations and Balance Sheet are on slides 28 and 29. We are pleased to report that our cash and investments were $191.2 million at September 30, 2026, The funds were expended in the third-quarter, principally directed to advancement of HCV Phase III clinical trials, see beyond and see forward, and to a lesser extent to the completion of clinical trial start-up activities, leading to the initiation of the Phase I study, AT587, our product candidate for the treatment of HEV. As we have noted, milestone events in each program have been recently realized with the announcement of positive top-line results in see beyond in July July, and the advancement of our Phase 1 clinical study of AT587. In the first 9 months of 2026, our R&D expenses decreased compared to the prior period, principally driven by a decrease in external spend related to our HCV Phase 3 clinical development program, offset by an increase in preclinical and clinical activities for our HEV program. In addition, we had lower internal research and development expenses, primarily related to lower stock-based compensation expense. G&A expenses decreased in the first nine months, given primarily by lower salaries and wages, lower stock based compensation expense, and lower professional fees. During the remainder of 2026, we intend to maintain our rigorous financial discipline while remaining laser focused on the execution and value creating advancement of both our HCV and HEV product candidates. As we complete C-Forward, our second phase three trial, prepare to submit our regulatory filings and engage in pre-launch activities, the substantial majority of our spending in 2026 will remain focused on the advancement of our Hepatitis C program. On slide 30, as announced earlier today, we entered into a credit facility agreement with Hercules Capital for up to $200 million. The facility is non-dilutive, strengthens our financial position, and provides additional capital to support commercial-related activities for the anticipated launch of the Regiment of BEM-RZR in the US, for the treatment of HCV, and advancement of the company's clinical program for HEV. Under the agreement, we received $65 million at closing on November the 6th, and based on our current operating plan together with our current resources, we expect that this will fund planned operations into mid-2028. ATEA may, at its option and subject to the achievement of specified milestones and other terms and conditions of the agreement access additional funding of up to $135 million. The credit facility has the potential to extend Attea's cash runway through profitability, assuming the successful commercial launch of Baton Rouge Sphere in the U.S. and future operating expenditures consistent with our current operating plans. For full credit agreement terms and disclosures, please refer to the Form 8K SEC filing that we made this morning. I'll now turn the call back to Jean-Pierre for closing remarks. Jean- Thank you, Andrea. In closing, slide 31 attests building momentum toward a series of major near-term milestones leading to bandwidth as via commercialization. We expect top-line results from C-fold in early 2027, and pending positive data, we are targeting our NDA submission for mid-2027. In parallel, our HEV program is advancing rapidly as we anticipate announcing phase one results early 2026, followed by initiation of a proof-of-concept study in the first half of 2027, with preliminary results expected over the end of the year. As we look forward to these key inflection points, we are very excited about the opportunity to translate our progress with BAM Resosvia into elevating the standard of care for HCVA. We believe BAM-Resosvia, a potential best-in-class profile, positions us to make a meaningful contribution to HCVA eradication in the U.S. and globally. With that, I will turn the call back over to the operator. Thank you. At this time, we'll start the Q&A session. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Maxwell Score with Morgan Stanley. Your line is now open. Hi. This is Jason on for Max. Thank you for taking our questions. Just a question on pair dynamics. Where are you in pair discussions? In particular, have conversations trended since CBON results were read out? I would love to know what feedback have pairs provided on the evidence needed to obtain favorable coverage. Thank you. All right, can you repeat the question, please? I'm sorry. Yeah, I was wondering where you are in paired discussions. In particular, how have conversations trended since CP Beyond results were read out? I would just love to know, like, what feedback you've gotten since then. Thank you. Our answer, and Janet? John. I think it's a pair, JP. Yeah, it's not a pair. Yeah, yeah. I think that was John. Yeah. So, as far as for, like, right now what we're doing is we are obviously completely assessing the current dynamics and landscape of the market, looking at all payers, whether it's commercial, Medicare, Medicaid, what is their current formulary, and if they have any restrictions, what percentage of those subscriptions go through, even if it is not a formulary. So at this time, we have not entered into discussions with them, but it's far too early. We don't have an approved product at this point. So once the FDA grants approval, then we'll be going through and executing our plan. Right now, understanding the landscape, understanding where we intend to go to commercialize our assets to hit our target on our forecast is what we've been doing currently. Great. Thank you. Thank you. Our next question comes from the line of John Miller with Evercore. Your line is now open. Hello. This is Junyuan on for John. So thanks for taking our question. So first question from us, can you confirm that the debt facility will be sufficient to fund commercial efforts within the U.S.? And then there's no expectation to raise capital from the equity market to launch? And the second question, have you heard any updates or progress on the HCV elimination bill in recent weeks? Any comments will be appreciated. The second question is a difficult time to answer. The second questions relate to HEV, right? HCV Elimination Bill, like the legislation efforts, yeah. Boy, I'm sorry, I can't understand. I can answer, Jean-Pierre. Okay, go ahead, Andrea. So thanks very much for the question. So, yes, the debt facility, the credit facility is exactly as you suggested, and so the $200 million would be more than sufficient to get us through the commercial launch, and it would alleviate the need for any equity financing. With respect to your second, I'm sorry, is there a follow-up? No, I can answer my second question. Thank you. Yes, so with respect to the second question regarding the HCV bill that's been pending, this was advanced by Senator Bill Cassidy, who, as you know, is the chairman of the HELP Committee. They did get Democratic sponsorship, but with the new Congress coming into being seated this week, our expectation is that bill will not go forward, and it would need to be reintroduced as a matter of procedure in the new congress to move forward. Without Senator Cassidy being there to act as the sponsor, It is unlikely that that would be one of the initial matters that the Congress will take up in 2027, based on the information we have today. Got it. Very helpful. Thank you. Thank you, as a reminder, to ask a question at this time, please press star one one on your touchstone telephone. Our next question comes from the line of Andy Shea with William Blair. Your line is now open. Thanks for taking our questions. One on HCV and one on HEV. Maybe for John, I'm just trying to get a sense of maybe the eventual breakdown between kind of government pay channels versus commercial channel upon your commercialization efforts. And also, So maybe you can comment on some of the movements, obviously from the government pay channel recently and how that could potentially impact your view and projections regarding the TAM there. Second question has to do with the HEV. There's the multiple ascending dose, I understand that for part A you're looking at PK and safety. For Part B, are you looking at healthy volunteers there as well? And if not, you're looking at patients. I'm curious if you'll be looking at some interesting PD data that we can expect in the second half of next year. Thank you. John? Sure. Thank you, Andy. So right now, what we do know through the evaluation of the HCV market in the United States today is roughly 50% of it is covered in Medicaid and then Medicare and the commercial other commercial aspects of the market share the remaining 50% and so that's how we're you know that's how the current market does exist today and what we are doing right now is that we are evaluating all the managed care situations between Madrigal and a boost in the United States for all three segments, commercial, Medicare, and Medicaid. We're developing our go-to strategy, assuming we get approval, to what we call high-value targeting. Where do we want to go? A lot of that is also going to be based on how fast we can get managed care uptake and coming in to realize what we're projecting in our forecast. You do ask a really good question, that what is the impact? And I think what I understand the question to be is that we're seeing a lot of movement in some of these government programs. Right. There's there's a there's the impact of the Inflation Reduction Act on Medicare. There's also the one big, beautiful bill and what it has done to, you know, Medicaid enrollees. And obviously, I think some of these are currently having some impact or likely having impact on the number of people that are treated for HCV in the United States. But I think, you know, what we believe and what the statistics are showing is that this is a market that is primed and it's actually getting larger and larger in terms of HCV, people living with HCV. Up to 4 million, as we've talked about before, are living with HCV in the United States. But even more importantly is that each year, you know, you're only, the amount of people that are diagnosed but untreated keeps increasing in this country. And so you're Only Treating around half of those that are Diagnosed. So I think there's other initiatives underway right now. There are certain state legislations in terms of shortening the duration between when a patient is diagnosed and treated. And I think there will be other initiatives there. At the end of the day, you have to do something about HCV in this country because if not left untreated, it will lead to, obviously, cirrhosis and to further liver cancer. Does that answer your question? Yes, absolutely. Thank you. Thank you, Janet. Do you want to answer to Andy? Yes, thank you. Yes, thank you. So your question was in regard to the Part B of the Phase 1 study. And actually, both single and multiple-dose parts are being conducted in Healthy Volunteers. And these are the data that we'll have early next year. And then we plan to be able to do a small proof-of-concept Phase 1B-type study where we'll start to see the PED in an infected subject. That's helpful. Thank you. Thank you. And I'm currently showing no further questions at this time. I'd now like to hand the call back over to JP for closing remarks. Thank you, thank you all for joining us for our short quarter conference call, and thank you again for your continued support. This concludes today's conference. Thank you for your participation. You may now disconnect.