Atea Pharmaceuticals Q3 2026 Earnings Call Transcript

Key Takeaways

  • Positive Sentiment: Atea reported that its phase III C-BEYOND trial met its primary and secondary endpoints: bemnifosbuvir/ruzasvir achieved a 94% SVR rate versus 95% for standard-of-care SOF/VEL, meeting the prespecified non-inferiority margin. The company highlighted the eight-week course for non-cirrhotic patients and said adverse events were comparable between treatment arms.
  • Neutral Sentiment: The next major HCV milestone is top-line data from the global C-FORWARD trial, expected in early 2027; if results are positive, Atea is targeting an NDA submission in mid-2027. The filing timeline therefore remains contingent on the upcoming readout.
  • Positive Sentiment: Atea ended September with $191.2 million in cash and marketable securities and closed a Hercules Capital facility with a $65 million initial draw and up to $135 million in additional funding, subject to conditions. Management expects current resources and the initial draw to fund operations into mid-2028 and said the facility could support commercialization without equity financing.
  • Negative Sentiment: Commercial preparation is underway, but Atea said it has not yet begun payer discussions because the product is not approved; it is currently assessing coverage and formulary dynamics. The company also said a pending HCV elimination bill is unlikely to be an early priority in the new Congress and would need to be reintroduced.
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Earnings Conference Call
Atea Pharmaceuticals Q3 2026
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Operator

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 on 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 Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae Barnes
Jonae Barnes
SVP of Investor Relations and Corporate Communications at Atea Pharmaceuticals

Good afternoon, everyone, and welcome to Atea Pharmaceuticals 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 Atea are Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi, Chief Development Officer, Dr. Janet Hammond, Chief Commercial Officer, John Vavricka, Chief Medical Officer, Dr. Arantxa Horga, 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.

Jonae Barnes
Jonae Barnes
SVP of Investor Relations and Corporate Communications at Atea Pharmaceuticals

These risk 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.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Thank you, Jonae. 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 III results of our North American trial for the treatment of HCV and the rapid clinical advancement of our phase I 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. C-BEYOND, our phase III trial evaluating the Bemnifosbuvir regimen for the treatment of HCV in North America, delivered strong results, meeting its primary and secondary endpoints, which of course is a major milestone for Atea. Arantxa will review the results of the trial in more detail.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

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 Bemnifosbuvir across a broad range of HCV genotypes. Pending this result, together with C-BEYOND, are expected to support a new drug application submission targeted for mid-2027 with the U.S. FDA. During the quarter, we also initiated a phase I clinical trial in healthy subjects for AT-587, a potential first-in-class direct-acting antiviral for chronic HEV, a serious disease for immunocompromised patients. I am pleased to report that the single ascending dose portion has been completed, and we are progressing in the multiple ascending dose portion. We anticipate advancing AT-587 into a proof-of-concept study in the first half of 2027, with preliminary results targeted for late 2027.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

We remain in a very solid financial position with $191.2 million in cash and marketable securities as of September 30, 2026. As announced today, we have entered into a credit facility agreement with Hercules Capital for up to $200 million, drawing down $65 million at closing. The staged 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 Bemnifosbuvir in 2028. Andrea will review the details of this new transaction. Moving to slide four, our program boasts a first-in-class potential, and we have now the financial runway to fund them through the major milestones detailed in this slide. Starting with HCV, Bemnifosbuvir's potential best-in-class profile combines high cure rates with short treatment durations, low risk of drug-drug interaction, and no food effect. The HCV market remains substantial.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

In 2025, global net sales were approximately $2.6 billion, including roughly $1.3 billion in the United States. For the Bemnifosbuvir regimen, we see peak U.S. net sales potential of more than $700 million. Turning to HEV, AT-587 is a potential first-in-class direct-acting antiviral. In an at-risk patient population, HEV can lead to chronic infection, cirrhosis, liver failure, or death, and there are no FDA-approved treatments. We estimate a commercial opportunity between $1 billion and $1.5 billion per year in patients with HEV in the United States and Europe. I will now hand the call over to Arantxa Horga, our Chief Medical Officer, to review our phase III program.

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

Thank you, Jean-Pierre. Good afternoon, everyone. Moving to slide six, C-BEYOND was a randomized, active-controlled, non-inferiority trial against sofosbuvir/velpatasvir, 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 Bemnifosbuvir/ruzasvir for eight weeks, or SOF/VEL for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. Slide seven outlines the C-BEYOND 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.

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

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 co-infection. On slide nine, C-BEYOND 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 route of HCV transmission. Approximately 89% were taking concomitant medications. A 2/3 had psychiatric disorders, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol. Let's now review the phase III results on slide 10.

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

In the primary endpoint mITT population, bemnifosbuvir/ruzasvir achieved a 94% SVR rate compared with 95% for SOF/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. Bemnifosbuvir/ruzasvir 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 SOF/VEL. On slide 11, in the non-cirrhotic mITT population, bemnifosbuvir/ruzasvir achieved a 94% SVR rate with eight weeks of treatment compared with 95% for SOF/VEL with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95% SVR rate with 12 weeks of treatment. Patient subpopulations are not powered for statistical analysis. On slide 12 is the safety summary. Overall adverse events were comparable between the two treatment arms.

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

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 bemnifosbuvir/ruzasvir and in three patients receiving SOF/VEL. None of these events were related to the study drug. There were no early treatment discontinuations related to the study drugs. 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 bemnifosbuvir/ruzasvir potential across a broader range of HCV genotypes.

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

C-FORWARD enrolled more diverse genotypes, 1b, 3b, 4b, 5b, and 6b, and uses the same non-inferiority methodology and powering assumptions as C-BEYOND. Together, we expect the two phase III 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.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

Thank you, Arantxa. Good afternoon, everyone. Moving on to slide 15, bemnifosbuvir/ruzasvir is a once-daily fixed-dose regimen. Bemnifosbuvir is a highly potent HCV nucleotide, and ruzasvir is a highly potent NS5A inhibitor. Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared with EPCLUSA and MAVYRET, bemnifosbuvir/ruzasvir 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 bemnifosbuvir/ruzasvir. Roughly 80%-90% of HCV patients in the U.S. take concomitant medications, and prescribers strongly prefer therapies that are simple to prescribe.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

Across oral contraceptives, protease inhibitors, and integrase inhibitor in HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors, as well as other acid-reducing therapies, bemnifosbuvir/ruzasvir 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 bemnifosbuvir/ruzasvir with methadone or SUBOXONE, two commonly used treatments for opioid use disorder. The study demonstrated a lack of drug-drug interactions, while co-administration was generally well tolerated in healthy volunteers. These data further support the potential applicability of bemnifosbuvir/ruzasvir 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.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

Based on the potential profile of bemnifosbuvir/ruzasvir, 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 am going to turn the call over to John Vavricka, our Chief Commercial Officer.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

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, and the 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 of 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.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

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 bemnifosbuvir/ruzasvir. Among high-volume DAA prescribers, 76% said they would be extremely likely to prescribe bemnifosbuvir/ruzasvir, and the research predicts roughly half of both non-cirrhotic and compensated cirrhotic patients would receive bemnifosbuvir/ruzasvir relative to EPCLUSA and MAVYRET. On slide 20, we believe bemnifosbuvir/ruzasvir is uniquely positioned to capture untreated patients and grow the market, not just simply compete for existing share. Currently, only about half of diagnosed patients in the U.S. are treated annually, leaving roughly 75,000 untreated diagnosed new infections last year, on top of the already large prevalent pool of patients.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

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, bemnifosbuvir/ruzasvir 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.S. 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 DAA prescriptions in the U.S..

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

We can reach the vast majority of this market with a focused specialty sales force of 75-100, 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. Our four-week dosing blister packaging supports patient convenience and adherence. I'll now hand the call back to Janet to review the HEV program.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

Thank you, John. On slide 24, in July, we initiated our phase I clinical trial of AT-587. The study is being conducted in healthy volunteers with the primary objectives of evaluating safety, tolerability, and pharmacokinetics. It is a randomized, double-blind, placebo-controlled design with sequential dose escalation and an embedded food effect assessment. The study includes both single ascending and multiple ascending dose phases, providing flexibility to refine dose levels as data emerge, with dose progression informed by real-time safety and PK review. I'm pleased to report that we have successfully completed the single ascending dose portion of the study, and we are now progressing in the multiple ascending dose cohorts. As phase I 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.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

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 improved 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 ribavirin administration, which both present challenges leading to a real opportunity for an effective direct-acting antiviral with the goal of developing a cure for HEV. There are currently no FDA-approved treatments for HEV. 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.

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

The unmet need for this patient population potentially represents a market opportunity between $1 billion and $1.5 billion a year. AT-587 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 will now turn the call over to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Thank you, Janet. As Jonae 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, C-BEYOND and C-FORWARD, and to a lesser extent, to the completion of clinical trial start-up activities, leading to the initiation of the phase I study, AT-587, 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 C-BEYOND in July and the advancement of our phase I clinical study of AT-587.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

In the first nine 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 III 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, driven 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.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

As we complete C-FORWARD, our second phase III 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 regimen of bemnifosbuvir/ruzasvir in the U.S. 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 6th, and based on our current operating plan, together with our current resources, we expect that this will fund planned operations into mid-2028.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

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 Atea's cash runway through profitability, assuming the successful commercial launch of bemnifosbuvir/ruzasvir 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 8-K SEC filing that we made this morning. I will now turn the call back to Jean-Pierre for closing remarks.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Thank you, Andrea. In closing, slide 31, Atea is building momentum toward a series of major near-term milestones leading to bemnifosbuvir/ruzasvir commercialization. We expect top-line results from C-FORWARD 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 I results early 2027, followed by initiation of a proof-of-concept study in the first half of 2027, with preliminary results expected toward 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 bemnifosbuvir/ruzasvir into elevating the standard of care for HCV. We believe bemnifosbuvir/ruzasvir, a potential best-in-class profile, position us to make a meaningful contribution to HCV eradication in the U.S. and globally. With that, I will turn the call back over to the operator.

Operator

Thank you. At this time, we will start the Q&A session. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Maxwell Skor with Morgan Stanley. Your line is now open.

Analyst at Morgan Stanley

Hi, this is [Jason] on for Max. Thank you for taking our questions. Just a question on payer dynamics. Where are you in payer discussions? In particular, have conversations trended since C-BEYOND results were read out? We'd love to know what feedback and payers provide on the evidence needed to obtain favorable coverage. Thank you.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Can you repeat the question, please, I'm sorry?

Analyst at Morgan Stanley

Yeah, I was wondering where you are in payer discussions. In particular, how have conversations trended since C-BEYOND results were read out? I would just love to know what feedback you've gotten since then. Thank you.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Arantxa and Janet?

Arantxa Horga
Arantxa Horga
Chief Medical Officer at Atea Pharmaceuticals

John.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

I think it's-

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

I think it's payers, JP.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Yeah, I think it was John.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

Yeah.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

John, yeah, [inaudible]

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

That's okay. 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 prescriptions go through, even if it is not formulary. At this time, we have not entered into discussions with them because it's far too early. We don't have an approved product at this time. Once the FDA grants approval, then we'll be going through and executing our plan. But right now, understanding the landscape, understanding where we intend to go to commercialize our asset to hit our target on our forecast is what we've been doing currently.

Analyst at Morgan Stanley

Great. Thank you.

Operator

Thank you. Our next question comes from the line of John Miller with Evercore. Your line is now open.

Analyst at Evercore

Hello, this is [inaudible] on for John. Thanks for taking our question. First question from us, can you confirm that the debt facility will be sufficient to fund commercial efforts within U.S., and then there's no expectation to raise capital from the equity market to launch? The second question, have you heard any updates or progress on the HCV elimination bill in recent weeks? Any comments will be appreciated.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

The second question, a difficult time to. Yeah. The second question related to HEV, right?

Analyst at Evercore

HCV elimination bill, like the—

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Yes, we can speak to that.

Analyst at Evercore

—legislation efforts, yeah.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Boy, I'm sorry, I cannot—

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Yes, I can answer, Jean-Pierre.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Okay, go ahead, Andrea.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Thanks very much for the question. Yes, the debt facility, the credit facility is exactly as you suggested, and 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, is there a follow-up?

Analyst at Evercore

No, can answer my second question. Thank you.

Andrea Corcoran
Andrea Corcoran
CFO and EVP of Legal at Atea Pharmaceuticals

Okay, yes. 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 Health 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.

Analyst at Evercore

Got it. Very helpful. Thank you.

Operator

Thank you. As a reminder, to ask a question at this time, please press star 11 on your touchtone telephone. Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open.

Andy Hsieh
Andy Hsieh
Analyst at William Blair

Thanks for taking our questions. One on HCV and one on HEV. Maybe for John, I am just trying to get a sense of maybe the eventual breakdown between government pay channels versus commercial channel upon your commercialization efforts. Also, 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 is the multiple ascending dose. I understand that for part A, you are looking at PK and safety. For part B, are you looking at healthy volunteers there as well? If not, you are looking at patients, I am curious if you will be looking at some interesting PD data that we can expect in the second half of next year. Thank you.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

John, [crosstalk] go ahead.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

Sure.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Yeah, go ahead.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

Thank you, Andy. 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 other commercial aspects of the market share the remaining 50%. That is how the current market does exist today. What we are doing right now is that we are evaluating all the managed care situations between MAVYRET and EPCLUSA in the United States for all three segments, commercial, Medicare, and Medicaid. We are 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 off of how fast we can get managed care uptake and coming in to realize what we are projecting in our forecast.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

You asked a really good question, and that is, what is the impact? I think what I understand your question to be is that we are seeing a lot of movement in some of these government programs, right? There is the impact of the Inflation Reduction Act on Medicare. There is also the One Big Beautiful Bill and what it has done to Medicaid enrollees. 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. I think what we believe and what the statistics are showing is that this is a market that is primed, and it is actually getting larger and larger in terms of HCV, people living with HCV. Up to 4 million, as we have talked about before, are living with HCV in the U.S.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

Even more importantly is that each year, the amount of people that are diagnosed but untreated keeps increasing in this country. You are only treating around half of those that are diagnosed. I think there are 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?

Andy Hsieh
Andy Hsieh
Analyst at William Blair

Yes, absolutely. Thank you.

John Vavricka
John Vavricka
Chief Commercial Officer at Atea Pharmaceuticals

Thank you.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Thanks. Janet, you want to answer to Andy?

Janet Hammond
Janet Hammond
Chief Development Officer at Atea Pharmaceuticals

Yes, thank you. Yes, thank you. Your question was in regard to the part B of the phase I study. 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. Then we plan to be able to do a small proof of concept, phase I-B type study, where we'll start to see the PD in infected subjects.

Andy Hsieh
Andy Hsieh
Analyst at William Blair

That is helpful. Thank you.

Operator

Thank you. I am currently showing no further questions at this time. I would now like to hand the call back over to JP for closing remarks.

Jean-Pierre Sommadossi
Jean-Pierre Sommadossi
CEO and Founder at Atea Pharmaceuticals

Thank you. Thank you all for joining us for our third quarter conference call, and thank you again for your continued support.

Operator

This concludes today's conference. Thank you for your participation. You may now disconnect.

Executives
    • Jonae Barnes
      Jonae Barnes
      SVP of Investor Relations and Corporate Communications
    • Jean-Pierre Sommadossi
      Jean-Pierre Sommadossi
      CEO and Founder
    • Arantxa Horga
      Arantxa Horga
      Chief Medical Officer
    • Janet Hammond
      Janet Hammond
      Chief Development Officer
    • John Vavricka
      John Vavricka
      Chief Commercial Officer
    • Andrea Corcoran
      Andrea Corcoran
      CFO and EVP of Legal
Analysts