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Atea Pharma (AVIR) Q3 2026 Earnings Call Transcript

The Motley Fool·11/10/2026 01:00:57
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DATE

Mon, Nov. 9, 2026

CALL PARTICIPANTS

  • Chief Executive Officer and Founder - Jean-Pierre Sommadossi
  • Chief Medical Officer - Maria Arantxa Horga
  • Chief Development Officer - Janet J. Hammond
  • Chief Commercial Officer - John F. Vavricka
  • Chief Financial Officer - Andrea J. Corcoran
  • Senior Vice President of Relations and Corporate Communications - Jonae R. Barnes

TAKEAWAYS

  • Cash and Marketable Securities -- $191.2 million as of Sept. 30, 2026, reflecting funding for Phase 3 clinical trials and HEV program start-up activities.
  • Hercules Capital Credit Facility -- Up to $200 million, including a $65 million drawdown at closing on Nov. 6, 2026, to support commercial activities for the BEM/RZR launch.
  • Cash Runway -- Funding projected into mid-2028, supported by existing resources and the new credit agreement.
  • C-BEYOND Primary Endpoint -- 94% SVR rate at week 24, meeting the 5% non-inferiority margin compared to 95% for the standard-of-care arm.
  • C-BEYOND Non-Cirrhotic Performance -- 94% SVR rate achieved with an 8-week treatment duration, versus 95% for the 12-week standard-of-care regimen.
  • Cirrhotic Patient Outcomes -- 95% SVR rate observed in both treatment arms after 12 weeks of therapy.
  • Research and Development Expenses -- $27.1 million for the quarter, decreasing from $38.3 million due to reduced external spending on HCV clinical development.
  • General and Administrative Expenses -- $6.9 million for the quarter, compared to $7.2 million, driven by lower stock-based compensation and professional fees.
  • Net Loss -- $32.2 million for the quarter, compared to a net loss of $42.0 million.
  • Peak US Net Sales Potential -- Exceeding $700 million for the BEM/RZR regimen, based on current prevalence and treatment gap data.
  • Hepatitis E Market Opportunity -- $1 billion to $1.5 billion annually in the United States and Europe, targeting immunocompromised patients.
  • US HCV Market Size -- $1.3 billion in net sales for 2025, representing roughly 50% of the $2.6 billion global market.
  • Projected US Addressable Market -- Up to $2.5 billion annually, reflecting an infected population estimated at 4 million people.
  • Sales Force Strategy -- 75 to 100 specialists planned to reach the 7,800 physicians who write 80% of all DAA prescriptions.
  • Patient Adherence Data -- Over 10% of trial participants discontinued treatment or were non-compliant, illustrating the challenges of real-world patient populations.
  • HCV Comorbidity Prevalence -- 80% to 90% of US patients take concomitant medications, highlighting the significance of the BEM/RZR low drug interaction profile.
  • C-FORWARD Results Timeline -- Early 2027 for topline data from the global trial involving patients across 17 countries.
  • NDA Submission Target -- Mid-2027 for the BEM/RZR regimen, assuming positive results from the remaining Phase 3 trial.
  • AT-587 Clinical Status -- Phase 1 single ascending dose portion completed, with the multiple ascending dose phase currently underway.
  • HEV Proof-of-Concept Milestone -- Scheduled for the first half of 2027, with preliminary results targeted for late 2027.

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RISKS

  • Corcoran stated that regarding the HCV elimination bill, "our expectation is that bill will not go forward" in the new congress, noting it would likely require reintroduction.

SUMMARY

Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) reported the successful achievement of primary and secondary endpoints in its C-BEYOND Phase 3 clinical trial for the treatment of hepatitis C. Management secured a $200 million credit facility from Hercules Capital, drawing down $65 million to strengthen its financial position through an anticipated 2028 commercial launch. The company remains focused on global Phase 3 data readouts for HCV and advancing its hepatitis E program toward proof-of-concept testing in 2027. Atea maintains a cash runway through mid-2028, prioritizing the development of its oral antiviral pipeline for serious viral infections.

  • CEO Sommadossi stated, "BEM/RZR's profile is uniquely suited to meet the needs of patients and providers embracing this model," in reference to the test-and-treat approach to HCV eradication.
  • The BEM/RZR regimen provides a short 8-week treatment duration for non-cirrhotic patients, which management stated is a critical differentiator from current 12-week standards.
  • Management reported that 50% of the current US HCV market is covered by Medicaid, with Medicare and commercial insurance sharing the remainder.
  • CFO Corcoran noted the $200 million facility provides capital to "alleviate the need for any equity financing" through the commercial launch period.
  • CDO Hammond indicated that Phase 1 results for the AT-587 HEV program are anticipated in early 2027, following the completion of healthy volunteer cohorts.
  • The company noted that roughly half of newly diagnosed HCV patients in the United States remain untreated, creating a growing prevalent pool of approximately 4 million people.

INDUSTRY GLOSSARY

  • BEM/RZR: A fixed-dose combination regimen consisting of bemnifosbuvir (a nucleotide NS5B inhibitor) and ruzasvir (an NS5A inhibitor).
  • DAA: Direct-acting antiviral, a class of medication used to treat chronic hepatitis C by targeting specific steps in the viral life cycle.
  • HCV: Hepatitis C virus, a blood-borne virus that primarily infects the liver and can lead to cirrhosis or liver cancer.
  • HEV: Hepatitis E virus, a viral infection that can become chronic in immunocompromised patients, leading to liver failure.
  • SVR: Sustained virologic response, the clinical definition of a cure when the virus is undetectable in the blood at a specific time after treatment completion.
  • mITT: Modified intent-to-treat, a clinical trial analysis population that includes all patients who received at least one dose of the study drug.

Full Conference Call Transcript

Operator: Good afternoon, everyone. Welcome to the Atea Pharmaceuticals Third Quarter 2026 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 Jonae R. Barnes, Senior Vice President of Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae R. Barnes: 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 will be reviewing today by going to the Investors section of our website at ir.ateapharma.com. With me today from Atea are our chief executive officer and founder, Doctor. Jean-Pierre Sommadossi chief development officer, Dr. Janet J. Hammond; commercial officer, John F. Vavricka chief medical officer, Dr. Maria Arantxa Horga; and chief financial officer; and our Senior Vice President of legal, Andrea J.

Corcoran, who will all be available for the Q&A portion of today's call. Before we begin the call and as outlined on Slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission. Which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I will now turn the call over to Jean-Pierre.

Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. During the third quarter, we made significant progress across our pipeline setting the stage for a milestone-rich 2027. With positive Phase 3 results of our North American trial, for the treatment of HCV and the rapid clinical advancement of our Phase 1 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 3 trial evaluating the BEM/RZR regimen for the treatment of HCV in North America.

Delivered strong results, meeting its primary and secondary endpoints which are a critical major milestone for our-- and, Janet,, we will review the results of the trial in more detail. We are on track to report top line results in early 2027 for C4 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 new drug application submission targeted for mid-2027 with the US FDA. During the quarter, we also initiated a Phase 1 clinical trial in healthy subjects for AT-587.

A potential first-in-class direct-acting antiviral for chronic HEV, a severe 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. We remain in a very solid financial position with $191.2 million in cash and marketable securities as of 9/30/2026. As announced today, we have entered into a credit facility agreement with a Hercules Capital for up to $200 million drawing down $65 million at closing.

The stage financing structure allows us to access capital and strengthen our flexibility in building commercialization robustness as we advance toward the anticipated US launch of BEM/RZR in 2028. And Andrea will review the details of this new transaction. Moving to Slide 4, Our program of best-in-class or 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, a potential best-in-class profile combines high cure rates, with short treatment durations, low risk of drug interactions, 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 BEM/RZR Regimen, we see peak US 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 populations. HEV can lead to chronic infection, cirrhosis, liver failure, or death. And there are no FDA approved treatments. We estimate the commercial opportunity between $1 billion and $1.5 billion per year in patients with HEV in the US. United States and Europe. Will now hand the call over to Maria Arantxa Horga, our chief medical officer to review our Phase 3 program.

Maria Arantxa Horga: Thank you, Jean-Pierre. Good afternoon, everyone. Moving to Slide 6, C-BEYOND was a randomized, active controlled non inferiority trial against sofosbuvir-velpatasvir marketed as Epclusa. Standard of care regimen. The trial enrolled patients with chronic HCV at approximately 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 BEM/RZR for 8 weeks. Or sofosbuvir-velpatasvir for 12 weeks. Patients with compensated cirrhosis receive 12 weeks of treatment with either regimen. Slide 7 outlines the CBEYOND 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 1 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 ENCORE trial for The US NDA submission. Moving to slide 8, the baseline characteristics of the patients in C-BEYOND were very well balanced across the 2 arms, including age, sex, BMI, race and ethnicity, cirrhosis status, viral load, and HIV coinfection. On Slide 9, 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 root of HCV transmission. Approximately 89% were taking concomitant medications. 2-thirds have 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, BEM/RZR achieved a 94% SVR rate compared with 95% for sofosbuvir-velpatasvir. At week 24, encompassing SVR12. The accepted definition of cure for HCV. These results met the primary endpoint of statistical non inferiority within the prespecified 5% margin.

Bemrusovir delivered cure rates comparable to the standard of care while offering an 8-week regimen for non cirrhotic patients. Which represent the majority of the patients in North America. Compared to 12 weeks of sofosbuvir-velpatasvir. On Slide 11, in the non cirrhotic MITT population, BEM/RZR, achieved a 94% SVR rate with 8 weeks of treatment compared with 95% for sofosbuvir-velpatasvir with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95% SVR rate with 12 weeks of treatment. Patients and populations are not powered for statistical analysis. Analysis. On Slide 12 is the safety summary. Overall adverse events were comparable between the 2 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 event resulted in death occurred in no patients receiving BEM/RZR and in 3 patients receiving sofosbuvir-velpatasvir. 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 3 trial being conducted outside of North America, to support a broad pangenotypic label. Building on the positive Phase 3 results from C-BEYOND, we are looking forward to this next important readout in early 2027.

And the opportunity to further demonstrate BEM/RZR potential across a broader range of HCV genotypes. C-FORWARD enrolls more diverse genotypes 1b, 3, 4, 5, and 6, and uses the same non inferiority methodology and powering assumptions as CBEYOND. Together, we expect the 2 Phase 3 studies will form a comprehensive global data package for regulators worldwide. I will now hand over the call to Janet J. Hammond, our Chief Development Officer.

Janet J. Hammond: Thank you, Arantxa. Afternoon, everyone. Moving on to Slide 15. BEM/RZR 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, BEM/RZR is the only regimen positioned to offer the full combination of short 8-week treatment duration for non cirrhotic patients, protease inhibitor free composition, a low potential for drug interactions, and no food effect. That combination is what we believe defines potential best-in-class profile. On Slide 16, the drug interaction profile is an important differentiator for BEM/RZR.

Roughly 80% to 90% of HCV patients in The US take concomitant medication. And prescribe a strongly preferred therapies that are simple to prescribe. Across oral contraceptives, protease inhibitors, and integrase inhibitors in HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors, as well as other acid reducing therapies, BEM/RZR is expected to be broadly compatible while competitors carry contraindications or require dose modification. Pure drug interactions can mean fewer specialist referrals, fewer treatment delays,, and more patients actually starting and completing therapy. Recently, we completed a Phase 1 study evaluating BEM/RZR with methadone or Suboxone. 2 commonly used treatments for opioid use disorder.

The study demonstrated a lack of drug interactions Our co administration was generally well tolerated from healthy volunteers. These data further support the potential applicability of bemrozavir across a broad range of HCV patients encountered in real world clinical practice. We plan to present 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 BEM/RZR, 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 F. Vavricka, our chief commercial officer.

John F. Vavricka: 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 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. 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. 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 BEM/RZR. Among high volume DDA prescribers, 76% said they would be extremely likely to prescribe BEM/RZR.

And the research predicts roughly half of both noncirrhotic and compensated cirrhotic patients. who would receive BEM/RZR relative to a competitor. On Slide 20, we believe BEM/RZR 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 US are treated annually. Leaving roughly 75 thousand untreated diagnosed new infections last year on top of the already large prevalent pool of patients. In 2025, HCV US net sales were $1.3 billion, representing 50% of global net sales of $2.6 billion. With its differentiated profile, BEM/RZR is uniquely positioned to expand the market. Which is potentially $2.5 billion annually in The US.

On Slide 21, taken together, we see peak annual US 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 US. With the number of untreated people increasing. Pricing is expected to be in line with existing branded DAA regimen. 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 7.8 thousand 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 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 supply is already underway with a low cost of goods relative to expected net pricing. And our 4-week dosing booster packaging supports patient convenience and adherence. I will now hand the call back to Janet to review the HEV program.

Janet J. Hammond: Thank you, John. On Slide 24, in July, we initiated our Phase 1 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 am 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 cohort.

As phase 1 development advances, we are 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 US 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 US and Europe, 3% of the approximately 545 thousand who have these underlying medical conditions are at risk of developing chronic hepatitis. 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 HCV 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 Ateo's financials.

Andrea J. Corcoran: 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 slide 28 and 29. We are pleased to report that our cash and investments were $191.2 million at 9/30/2026. The funds were expended in the third quarter principally directed to advancement of HCV phase 3 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 1 study of 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 1 clinical study of AT-587. 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 9 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. As we complete C-FORWARD, our second Phase 3 trial, prepare to submit our regulatory filings, and engage in prelaunch 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 nondilutive, strengthens our financial position, and provides additional capital to support commercial related activities for the anticipated launch of the regimen 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 6. And based on our current operating plan, together with our current resources, we expect that this will fund planned operations into mid 28. Atea may, at its option, and subsequent 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 the cash runway through profitability assuming the successful commercial launch of BEM/RZR in The US, 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: Thank you, Andrea. In closing, Slide 31, Atea is building momentum. Toward a series of major near term milestones leading to BEM/RZR 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 1 results early 27. 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 BEM/RZR into elevating the standard of care for HCV.

We believe BEM/RZR has a potential best-in-class profile that will position us to make a meaningful contribution to HCV eradication in The US 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 *1 on your telephone and wait for your name to be announced. To withdraw your question, please press *1 again. Our first question comes from the line of Maxwell Skor with Morgan Stanley. Your line is now open.

Maxwell Skor: Hi. This is Jason on for Maxwell. Thank you for taking our questions. Just a question on payer dynamics. Where are you in payer discussions in particular, have conversations trended since CBEYOND results were read out? I would love to know what feedback have payers provided on the evidence needed to obtain favorable coverage. Thank you.

Jean-Pierre Sommadossi: Wait. Can you repeat the question, please? I am sorry.

Maxwell Skor: 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, like, what feedback you have gotten. Since then. Thank you.

Jean-Pierre Sommadossi: Arantxa and Janet? John? I think the-- actually, I think the payer-- JP.

John F. Vavricka: Yep. So the-- Yeah. Yeah. Sorry about that. that is okay. So as far as for. Like, right now, we are doing is that we are obviously completely assessing the current dynamics and landscape for the market. Looking at all payers, whether it is commercial, Medicare, Medicaid, what is their current formulary, and if they have any restrictions, what percentage of these prescriptions go through even if it is not formulary. So at this time, we have not entered into discussions with them because it is far too early. We do not have an approved product at this time. So once the FDA grants approval, then we will be going through and executing our plan.

But right now, understanding the landscape understanding where we intend to go to commercialize our assets to hit our target on our forecast and moving to achieve our goals.

Maxwell Skor: Great. Thank you.

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

Jonathan Miller: Hello. This is Xueyen 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 ex-U.S.? And then there is no expectation to raise capital from the equity market to launch. And the second question is, have you heard any updates or progress on the HCV elimination bill in recent-- any comments will be appreciated.

Jean-Pierre Sommadossi: The second question, difficult time to-- Yeah. Yeah. The second question related to HEV. Right? HCV elimination bill. Like, the Yes. Yes. We can speak to that. Legislation efforts. Yeah. Boy, I. I am sorry. I cannot-- so, yes, I can answer, Jean-Pierre. Okay.

Operator: Go ahead, Andrea.

Andrea J. Corcoran: 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. And with respect to your second.

Jonathan Miller: I am sorry. Is there a follow-up?

Andrea J. Corcoran: No. Okay, that answers my question. Thank you. Yes. So with respect to the second question regarding the HCV bill that is 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 would be 1 of the initial matters that, the congress will take up in 2027 based on the information we have today.

Jonathan Miller: Got it. Very helpful. Thank you.

Operator: Thank you. As a reminder to ask a question at this time, please press *1 on your touchtone telephone. Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open.

Andy Hsieh: Thanks for taking our questions. 1 on HCV and 1 on HEV. And for John, I am just trying to get a sense of maybe the eventual breakdown between kind of government pay channels versus commercial channel upon your commercialization efforts? Mhmm. And, 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?

And if not, and you are looking at patients. I am curious if you will be looking at some early PD data that we could expect in the second half of next year. Thank you.

John F. Vavricka: Sure. Yep. So thank you, Andy. So right now, what we do know through our. 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 is 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 Mavyret and Epclusa in The United States for all 3 segments. Commercial, Medicare, and Medicaid. We are. We are developing our go-to-market strategy assuming we get approval. To what we call high value targeting.

Where do we want to go? A lot of that is also gonna be based on how fast we can get managed care uptake and coming in to realize what we are projecting in our forecast. You do have to-- you asked a really good question, and that the. What is the impact? And 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, you know, inflation reduction act on Medicare, there is also the unwinding of the public health emergency on what it has done to you know, Medicaid enrollees.

And I obviously, I think some of these are having currently having some impact or likely having impact on the, you know, the number of people that are treated for HCV in The United States. But I think, you know, what we believe and what the what the statistics are showing is that the. This is a market that is primed, 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 United States. But even more importantly is that each year, you are only you are.

The amount of people that are diagnosed but untreated keeps increasing in this country. And so you are only treating around half of those that are diagnosed. So I think there is 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 it is not. that is untreated Will lead to, obviously, cirrhosis and to further liver cancer. That answer your question?

Andy Hsieh: Yes. Absolutely. Thank you.

John F. Vavricka: Thank you.

Jean-Pierre Sommadossi: Thanks. Janet, you want to answer Andy?

Janet J. Hammond: 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 will have early next year. And then we plan to be able to, do a small proof-of-concept Phase 1b-type study where we will start to see the PD in infected subjects.

Andy Hsieh: that is helpful. Thank you.

Operator: Thank you. And I am currently showing no further questions at this time. I would now like to hand the call back over to Jean-Pierre for closing remarks.

Jean-Pierre Sommadossi: Thank you. Thank you all for joining us. our third-quarter conference call,, and thank you again for your continued support.

Operator: This concludes today's conference. Thank you for your participation, and you may now disconnect.

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