Q2 2026 Atea Pharmaceuticals Inc Earnings Call

August 12, 2026

Speaker #1: Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Second Quarter 2026 Financial Results and Business Update conference call. At this time, all participants are in a listen-only mode.

Operator 3: Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Q2 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 Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Operator: Good afternoon, everyone, and welcome to the Atea Pharmaceuticals Q2 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 Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Speaker #1: 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.

Speaker #2: Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' second quarter 2026 financial results and business update conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss.

Jonae Barnes: Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals Q2 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 investor section of our website at ir.ateapharma.com. With me from Atea, our 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, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, who will 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.

Speaker #2: You can access the press release, as well as the slides that we will be reviewing today, by going to the investor section of our website at ir.ateapharma.com.

Speaker #2: With me from Atea, our 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 Jurga, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran.

Speaker #2: Who will 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.

Speaker #2: 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.

Jonae Barnes: 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.

Speaker #2: 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: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on slide 3. The positive top-line results from C-BEYOND, our phase III trial evaluating the combination of bemnifosbuvir for the treatment of Hepatitis C in North America, represent a significant milestone for Atea and for the millions of people living with Hepatitis C who need a shorter, simpler path to cure. We were very pleased that C-BEYOND met both its primary and secondary endpoints, with bemnifosbuvir demonstrating statistical non-inferiority to EPCLUSA, the current standard of care. Importantly, this was the first successful phase III trial in the global head-to-head HCV program, achieved in the real-world patient population that was polymedicated, psychiatrically complex, substance abuse affected, and adherence challenged. These results reinforce the need for a best-in-class profile designed for the broad and complex Hepatitis C population clinicians treat today.

Speaker #3: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on slide 3. The positive topline results from CBR, our Phase 3 trial evaluating the combination of BEM versus VA for the treatment of hepatitis C in North America, represent a significant milestone for Atea.

Speaker #3: And for the millions of people living with hepatitis C, we need a shorter, simpler path to cure. We were very pleased that CBR met both its primary and secondary endpoints with BEM versus VA, demonstrating statistical non-inferiority to Epclusa, the current standard of care.

Speaker #3: Importantly, this was the first successful Phase 3 trial in the global, head-to-head HCV program, achieved in a real-world patient population that was polymedicated, psychiatrically complex, affected by substance abuse, and adherence challenged.

Speaker #3: These results reinforce the need for a best-in-class profile designed for the broad and complex hepatitis C population clinicians treat today. Aransa, let’s review in detail the results of the trial.

Jean-Pierre Sommadossi: Arancha will review in details the results of the trial. C-FORWARD, our second phase III trial being conducted outside North America, is fully enrolled with more than 880 patients, and we remain on track to report top-line results in early Q1 2027. We believe that the C4 dataset will provide important confirmatory efficacy data across a broader range of genotypes and strengthen the pangenotypic regulatory package for bemnifosbuvir. in July, we also initiated our first in-human Phase 1 clinical trial of AT-587, our potential first in class direct-acting antiviral for chronic Hepatitis E, a serious disease with no approved therapy today. This milestone reflects the continued advancement of our old direct-acting antiviral pipeline. We remain in the solid financial position with $219.5 million in cash and marketable securities as of 30 June 2026, with our cash runway anticipated through 2027.

Speaker #3: C4, our second Phase 3 trial being conducted outside North America, is fully enrolled with more than 880 patients, and we remain on track to report top-line results in early Q1 2027.

Speaker #3: We believe that the C4 dataset will provide important confirmatory efficacy data across a broader range of genotypes and strengthen the pan-genotypic regulatory package for BEM versus VA.

Speaker #3: In July, we also initiated our first-in-human Phase 1 clinical trial of 8587, our potential first-in-class direct-acting antiviral for chronic hepatitis E, a serious disease with no approved therapy today.

Speaker #3: This milestone reflects the continued advancement of our oral direct-acting antiviral pipeline, we remain in the solid financial position with 219.5 million dollars in cash and marketable securities as of June 30, 2026.

Speaker #3: With our cash runway anticipated through 2027, I will now hand the call over to Aransa, our Chief Medical Officer, to review our Phase 3 program.

Jean-Pierre Sommadossi: I will now hand the call over to Arancha, our Chief Medical Officer, to review our Phase III program.

Speaker #4: Thank you, Jean-Pierre. Good afternoon, everyone. Moving to slide 5, CBR was a randomized active control non-inferiority trial against sofosbuvir/velpatasvir, marketed as Epclusa, a standard of care regimen.

Rachel Smith: Thank you, Jean-Pierre. Good afternoon, everyone. Moving to Slide 5, C-BEYOND was a randomized active control non-inferiority trial against sofosbuvir/velpatasvir, marketed as EPCLUSA, a standard of care regimen. The trial involved patients with chronic HCV at approximately 120 clinical sites in the US and Canada, including patients co-infected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received bemnifosbuvir for 8 weeks or SOF/VEL for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. On Slide 6, let's now review the C-BEYOND endpoints and patient populations. The primary efficacy endpoint is SVR or cure at week 24, assessing the modified intent to treat or MITT population, which was agreed upon with the FDA.

Arantxa Horga: Thank you, Jean-Pierre. Good afternoon, everyone. Moving to Slide 5, C-BEYOND was a randomized active control non-inferiority trial against sofosbuvir/velpatasvir, marketed as EPCLUSA, a standard of care regimen. The trial involved patients with chronic HCV at approximately 120 clinical sites in the US and Canada, including patients co-infected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received bemnifosbuvir for 8 weeks or SOF/VEL for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. On Slide 6, let's now review the C-BEYOND endpoints and patient populations. The primary efficacy endpoint is SVR or cure at week 24, assessing the modified intent to treat or MITT population, which was agreed upon with the FDA.

Speaker #4: The trial enrolled patients with chronic HCV at approximately 120 clinical sites in the US and Canada, including patients co-infected with HIV and patients across the HCV genotypes that predominate in North America.

Speaker #4: Patients without cirrhosis received BEM versus VA for 8 weeks, or SOF/VEL for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen.

Speaker #4: On slide 6, let's now review the CBR endpoints and patient population. The primary efficacy endpoint is SVR, or cure, at week 24, assessing the modified intent-to-treat, or MITT, population, which was agreed upon with the FDA.

Speaker #4: 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.

Rachel Smith: 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 US NDA submission. Moving to Slide 7, you can see that 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 8, C-BEYOND enrolled the HCV population clinicians are treating in North America today, which looks meaningfully different from the population studied a decade ago. In our trial, more than half of the patients reported injection drug use as the root of HCV transmission.

Arantxa Horga: 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 US NDA submission. Moving to Slide 7, you can see that 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 8, C-BEYOND enrolled the HCV population clinicians are treating in North America today, which looks meaningfully different from the population studied a decade ago. In our trial, more than half of the patients reported injection drug use as the root of HCV transmission.

Speaker #4: The trial is powered at 90 percent, with a 5 percent non-inferiority margin. CBR is the anchor trial for the U.S. NDA submission. Moving to slide 7, you can see that the baseline characteristics of the patients in CBR were very well balanced across the two arms, including age, sex, BMI, race and ethnicity, cirrhosis status, viral load, and HIV co-infection.

Speaker #4: On slide 8, CBR enrolled the HCV population clinicians that are treating in North America today, which looks meaningfully different from the population studied a decade ago.

Speaker #4: In our trial, more than half of the patients reported injection drug use as the root of HCV transmission. Approximately 89 percent were taking concomitant medications, two-thirds had a psychiatric disorder, and over 10 percent prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol.

Rachel Smith: Approximately 89% were taking concomitant medications, two-thirds had a psychiatric disorder, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol. Current standard of care regimens have challenges where it matters most. A moderate protease inhibitor-containing regimen carries DDI limitations that restrict or complicate use in many of these patients, while EPCLUSA requires 12 weeks of treatment. In our market research, only 6% of 157 high-prescribing US physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications. Let's now review the phase III results on Slide 9. In the primary endpoint MITT population, bemnifosbuvir achieved a 93.9% SVR rate compared with 94.8% for SOF/VEL at week 24, encompassing SVR12, the accepted definition of cure for HCV. This result met the primary endpoint of statistical non-inferiority within the pre-specified 5% margin.

Arantxa Horga: Approximately 89% were taking concomitant medications, two-thirds had a psychiatric disorder, and over 10% prematurely discontinued treatment, were lost to follow-up, or were not adherent to the protocol. Current standard of care regimens have challenges where it matters most. A moderate protease inhibitor-containing regimen carries DDI limitations that restrict or complicate use in many of these patients, while EPCLUSA requires 12 weeks of treatment. In our market research, only 6% of 157 high-prescribing US physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications. Let's now review the phase III results on Slide 9. In the primary endpoint MITT population, bemnifosbuvir achieved a 93.9% SVR rate compared with 94.8% for SOF/VEL at week 24, encompassing SVR12, the accepted definition of cure for HCV. This result met the primary endpoint of statistical non-inferiority within the pre-specified 5% margin.

Speaker #4: Current standard-of-care regimens have challenges where it matters most. A moderate protease inhibitor-containing regimen carries DDI limitations that restrict or complicate use in many of these patients, while Epclusa requires 12 weeks of treatment.

Speaker #4: In our market research, only 6% of 157 high-prescribing U.S. physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications.

Speaker #4: Let's now review the phase 3 results on slide 9. In the primary endpoint MITT population, BEM versus VA achieved a 93.9% SVR rate compared with 94.8% for SOF/VEL at week 24.

Speaker #4: 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.

Speaker #4: BEM versus VA delivered cure rates comparable to the standard of care, while offering an 8-week regimen for non-cirrhotic patients, compared to 12 weeks for SOF/VEL.

Rachel Smith: Bemnifosbuvir delivered cure rates comparable to the standard of care while offering an eight-week regimen for non-cirrhotic patients, compared to 12 weeks for SOF/VEL. On Slide 10, in the non-cirrhotic MITT population, bemnifosbuvir achieved a 93.5% SVR rate with eight weeks of treatment, compared with 94.6% for SOF/VEL with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate with 12 weeks of treatment. Patients subpopulations are not powered for statistical analysis. On Slide 11 is the safety summary. Overall, adverse events were comparable between the two treatment arms. Most treatment-emergent adverse events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drugs, and while there were no deaths in the bemnifosbuvir arm, three deaths in the sofosbuvir arm were observed, but not related to the study drug.

Arantxa Horga: Bemnifosbuvir delivered cure rates comparable to the standard of care while offering an eight-week regimen for non-cirrhotic patients, compared to 12 weeks for SOF/VEL. On Slide 10, in the non-cirrhotic MITT population, bemnifosbuvir achieved a 93.5% SVR rate with eight weeks of treatment, compared with 94.6% for SOF/VEL with 12 weeks of treatment. In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate with 12 weeks of treatment. Patients subpopulations are not powered for statistical analysis. On Slide 11 is the safety summary. Overall, adverse events were comparable between the two treatment arms. Most treatment-emergent adverse events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drugs, and while there were no deaths in the bemnifosbuvir arm, three deaths in the sofosbuvir arm were observed, but not related to the study drug.

Speaker #4: On slide 10, in the non-cirrhotic MITT population, BEM versus VA achieved a 93.5% SVR rate with 8 weeks of treatment, compared with 94.6% for SOF/VEL with 12 weeks of treatment.

Speaker #4: In patients with compensated cirrhosis, both arms achieved a 95.4% SVR rate with 12 weeks of treatment. Patient subpopulations are not powered for statistical analysis.

Speaker #4: On slide 11 is the safety summary. Overall, adverse events were comparable between the two treatment arms. Most treatment-emergent adverse events were mild to moderate and balanced between treatment arms.

Speaker #4: There were no serious adverse events due to the study drugs, and while there were no deaths in the BEM versus VA arm, three deaths in the soft VEL arm were observed, but not related to the study drug.

Speaker #4: Similarly, there were no early treatment discontinuations related to the study drugs. Moving to slide 12, real-world adherence and discontinuation of treatment with lost to follow-up remains a major barrier in HCV treatment today, and helps explain why current SVR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies.

Rachel Smith: Similarly, there were no early treatment discontinuations related to the study drugs. Moving to Slide 12, real-world adherence and discontinuation of treatment with loss to follow-up remains a major barrier in HCV treatment today and helps explain why current SVR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies. Indeed, as you can see, in more recent studies, the intent to treat SVR rates fall below the rates reflected in labels established a decade ago, including rates as low as 74% among people who injected drugs, with rates consistently in the low 90s. Slide 13 summarizes the top-line results for C-BEYOND. The trial met its primary and secondary endpoint, with bemnifosbuvir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotype. Virological failure rates were low and comparable across treatment arms.

Arantxa Horga: Similarly, there were no early treatment discontinuations related to the study drugs. Moving to Slide 12, real-world adherence and discontinuation of treatment with loss to follow-up remains a major barrier in HCV treatment today and helps explain why current SVR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies. Indeed, as you can see, in more recent studies, the intent to treat SVR rates fall below the rates reflected in labels established a decade ago, including rates as low as 74% among people who injected drugs, with rates consistently in the low 90s. Slide 13 summarizes the top-line results for C-BEYOND. The trial met its primary and secondary endpoint, with bemnifosbuvir demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotype. Virological failure rates were low and comparable across treatment arms.

Speaker #4: Indeed, as you can see, more recent studies, the intent-to-treat SVR rates fall below the rates reflected in labels established a decade ago.

Speaker #4: Including rates as low as 74%. Among people who injected drugs, with rates consistently in the low 90s. Slide results for CBR: The trial met its primary and secondary endpoints, with BEM versus VA demonstrating consistent SVR rates regardless of cirrhosis status and robust performance across genotypes.

Speaker #4: Biological failure rates were low and comparable across treatment arms. BEM versus VA was generally safe and well tolerated, with a safety profile comparable to soft VEL.

Rachel Smith: bemnifosbuvir was generally safe and well-tolerated, with a safety profile comparable to sofosbuvir. On slide 14 is the patient populations and analysis for C-FORWARD, our second phase III trial being conducted outside of North America to enable a broad pangenotypic label. It is fully enrolled and enriched for genotypes 1b, 3, 4, 5, and 6, using the same non-inferiority methodology and the same powering assumptions. Together, the two phase III studies will form a comprehensive global data package for regulators worldwide. I will now hand the call over to Janet, our Chief Development Officer.

Arantxa Horga: bemnifosbuvir was generally safe and well-tolerated, with a safety profile comparable to sofosbuvir. On slide 14 is the patient populations and analysis for C-FORWARD, our second phase III trial being conducted outside of North America to enable a broad pangenotypic label. It is fully enrolled and enriched for genotypes 1b, 3, 4, 5, and 6, using the same non-inferiority methodology and the same powering assumptions. Together, the two phase III studies will form a comprehensive global data package for regulators worldwide. I will now hand the call over to Janet, our Chief Development Officer.

Speaker #4: On slide 14, the patient population and analysis for C4, our second Phase 3 trial, are being conducted outside of North America to enable a broad pan-genotypic label.

Speaker #4: It is fully enrolled, and enriched for genotypes 1b, 3, 4, 5, and 6, using the same non-inferiority methodology and the same powering assumptions. Together, the two Phase 3 studies will form a comprehensive global data package for regulators worldwide.

Speaker #4: I will now hand the call over to Janet, our Chief Development Officer.

Speaker #5: Thank you, Rancha. Good afternoon, everyone. Moving on to slide 16, BEM versus VA is a next-generation pan-genotypic, once-daily, six-dose regimen. Manophosphor is the most potent nucleotide we are aware of.

Janet Hammond: Thank you, Arancha. Good afternoon, everyone. Moving on to slide 16, bemnifosbuvir is a next-generation pangenotypic once daily six-dose regimen. bemnifosbuvir is the most potent nucleotide we are aware of, being approximately tenfold more active than sofosbuvir in vitro, and ruzasvir is a picomolar potency pangenotypic NS5A inhibitor. Together, they have been administered to thousands of individuals with generally favorable safety and tolerability. Compared to EPCLUSA and MAVYRET, bemnifosbuvir/ruzasvir is the only regimen positioned to offer the full combination of short eight-week duration for non-cirrhotic patients, protease inhibitor-free composition, low potential for drug-drug interactions, and no food effect. That combination is what defines a potential best-in-class profile. On slide 17, the drug-drug interaction profile is a key differentiator for bemnifosbuvir/ruzasvir. Roughly 80% to 90% of Hepatitis C patients in the United States take concomitant medications, and prescribers strongly prefer therapies that are simple to prescribe.

Speaker #5: Being approximately 10-fold more active than some phosphovir in vitro. And versus VA is a peak molar potency pan-genotypic NSIV inhibitor. Together, they have been administered to thousands of individuals, with generally favorable safety and tolerability.

Speaker #5: Compared to Epclusa and Mavyret, BEM versus VA is the only regimen positioned to offer the full combination of short 8-week duration for non-cirrhotic patients, protease inhibitor–free composition, low potential for drug–drug interactions, and no food effect.

Speaker #5: That combination is what defines a potential best-in-class profile. On slide 17, the drug-drug interaction profile is a key differentiator for BEM versus VA. Roughly 80% to 90% of hepatitis C patients in the United States take concomitant medications.

Speaker #5: And prescribers strongly prefer therapies that are simple to prescribe. Across the classes of oral contraceptives, protease inhibitors, and integrase inhibitor HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors and other acid-reducing therapies, BEM versus VA is expected to be broadly compatible, where competitors carry contraindications or require dose modification.

Janet Hammond: Across the classes of oral contraceptives, protease inhibitors, and integrase inhibitor HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors, and other acid-reducing therapies, bemnifosbuvir/ruzasvir is expected to be broadly compatible where competitors carry contraindications or require dose modifications. Fewer drug interactions, scrutiny, fewer specialist referrals, fewer treatment delays, and more patients actually starting and completing therapy. Today's treatment challenge is less about efficacy and more about treatment duration, adherence, drug-drug interactions, and access. Based on the potential profile of bemnifosbuvir/ruzasvir, we believe our regimen is well-positioned to address these barriers and expand the number of patients successfully treated. I'll now turn the call over to John Vavricka, our Chief Commercial Officer.

Speaker #5: Fewer drug interactions should mean fewer specialist referrals, fewer treatment delays, and more patients actually starting and completing therapy. Today's treatment challenge is less about efficacy and more about treatment duration, adherence, drug-drug interactions, and access.

Speaker #5: Based on the potential profile of BEM versus VA, we believe our regimen is well positioned to address these barriers and expand the number of patients successfully treated.

Speaker #5: I'll now turn the call over to John Vavricka, our Chief Commercial Officer.

Speaker #2: Thank you, Janet. Let's move on to slide 19. I want to address what we believe is a widely misunderstood dynamic in the HCV market.

John Vavricka: Thank you, Janet. Let's move on to slide 19. I want to address what we believe is a widely misunderstood dynamic in the HCV market. Wall Street often looks at revenue trends for approved HCV therapies and concludes that this is a declining market. However, the prevalence in treatment data tell a different story. Newly diagnosed patients with HCV infections continue to outpace patients treated annually, and that gap is widening. In 2025, only around 50% of those new infected patients 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. The test and treat model of care is emerging as a reality and will serve as a critical lever to close the gap of untreated patients.

Speaker #2: Wall Street often looks at revenue trends for approved HCV therapies and concludes that this is a declining market. However, the prevalence and treatment data tell a different story.

Speaker #2: Newly diagnosed patients with HCV infections continue to outpace patients treated annually, and that gap is widening. In 2025, only around 50 percent of those newly infected patients were treated.

Speaker #2: The result is a growing HCV-infected population, moving towards 4 million people in the United States, which is an expanding addressable market. The test and treat model of care is emerging as a reality, and will serve as a critical lever to close the gap of untreated patients.

Speaker #2: It will enable seamless, rapid diagnosis and treatment initiation at the same point-of-care visit, reduce barriers for prescribing, and drastically reduce patient attrition even before treatment begins.

John Vavricka: It will enable seamless rapid diagnosis and treatment initiation at the same point of care visit, reduce barriers for prescribing, and drastically reduce patient attrition even before treatment begins. This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in the United States. We believe our regimen's profile is optimal for this model of care. Let's move on to slide 20. The current HCV market dynamics create a clear opportunity for bemnifosbuvir. Short duration regimens continue to gain share, and prescribing is increasingly driven by polypharmacy and comorbidities. New infections keep outpacing treatment, and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strengths of bemnifosbuvir. We believe a potential best-in-class profile can expand treatment eligibility and improve treatment completion for patients whose medications, comorbidities, and life circumstances have historically limited access and adherence.

Speaker #2: This model has broad bipartisan support and is gaining momentum as a pathway toward HCV eradication in the United States. We believe our regimen's profile is optimal for this model of care.

Speaker #2: Let's move on to slide 20. The current HCV market dynamics create a clear opportunity for BEMRZR. Short duration regimens continue to gain share, and prescribing is increasingly driven by polypharmacy and comorbidities.

Speaker #2: New infections keep outpacing treatment, and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strengths of BEM RZR.

Speaker #2: We believe a potential best-in-class profile can expand treatment eligibility and improve treatment completion for patients whose medications, comorbidities, and life circumstances have historically limited access and adherence.

Speaker #2: In addition, there is a market growth potential with a simplified therapy and a focused commercialization effort. Moving on to slide 21. Our market research supports strong uptake of BEM RZR.

John Vavricka: In addition, there is a market growth potential with a simplified therapy and a focused commercialization. Moving on to slide 21. Our market research supports strong uptake of bemnifosbuvir. Among high volume DAA prescribers, 76% said they would be extremely likely to prescribe bemnifosbuvir, and the research predicts roughly half of both non-cirrhotic and compensated cirrhotic patients would receive bemnifosbuvir relative to EPCLUSA and MAVYRET. On slide 22, we believe bemnifosbuvir is uniquely positioned to capture untreated patients and grow the market, not simply to compete for existing share. Currently, only about half of diagnosed patients in the US are treated annually, leaving roughly 75,000 untreated new infections last year, on top of the already large prevalent pool of patients. In 2025, US net sales were $1.3 billion, representing 50% of the global net sales of $2.6 billion.

Speaker #2: Among high-volume DAA prescribers, 76% said they would be extremely likely to prescribe BEMRZR. And the research predicts roughly half of both non-cirrhotic and compensated cirrhotic patients would receive BEMRZR relative to Epclusa and Maviret.

Speaker #2: On slide 22, we believe BEM RZR is uniquely positioned to capture untreated patients and grow the market, not simply to compete for existing share.

Speaker #2: Currently, only about half of diagnosed patients in the U.S. are treated annually, leaving roughly 75,000 untreated new infections last year on top of the already large prevalent pool of patients.

Speaker #2: In 2025, US net sales were $1.3 billion, representing 50 percent of the global net sales of $2.6 billion. With its differentiated profile, BEM RZR is uniquely positioned to expand the market, potentially up to $2.5 billion annually in the United States.

John Vavricka: With its differentiated profile, bemnifosbuvir is uniquely positioned to expand the market, potentially up to $2.5 billion annually in the United States. Slide 23. Taken together, we see peak annual US net revenue potential in excess of $700 million. That's anchored on a widening gap between infections and cures, up to 4 million infected, and the increasing number of untreated people in the United States as the total addressable market. The pricing is expected to be in line with existing branded DAA regimens. In closing, on slide 24, we continue to advance our commercial readiness activities across all key areas. The HCV prescriber base is highly concentrated, with approximately 7,800 physicians writing roughly 80% of all DAA prescriptions in the US.

Speaker #2: Slide 23. Taken together, we see peak annual U.S. net revenue potential in excess of $700 million. That's anchored on a widening gap between infections and cures, up to 4 million infected, and the increasing number of untreated people in the United States as the total addressable market.

Speaker #2: The pricing is expected to be in line with existing branded DAA regimens. In closing, on slide 24, we continue to advance our commercial readiness activities across all key areas.

Speaker #2: The HCV prescriber base is highly concentrated, with approximately 7,800 physicians writing roughly 80 percent of all DAA prescriptions in the U.S. We can reach the vast majority of this market with a focused specialty sales force of approximately 75 to 100, including sales representatives, sales managers, and medical science liaisons.

John Vavricka: We can reach the vast majority of this market with a focused specialty sales force of approximately 75 to 100, including sales representatives, sales managers, and medical science liaisons. All components and processes for large-scale manufacturing are in place. Our commercial launch supply is already underway with low cost of goods relative to the expected net price, and our four-week dosing blister card packaging supports patient convenience and adherence. We believe these factors position us for a short time to profitability following a launch. I'll now turn the call back to Janet to review the hepatitis E program.

Speaker #2: All components and processes for large-scale manufacturing are in place. Commercial launch supply is already underway, with low cost of goods relative to the expected net price. And our four-week dosing blister card packaging supports patient convenience and adherence.

Speaker #2: We believe these factors position us for a short time to profitability following a launch. I'll now turn the call back to Janet to review the hepatitis C program.

Speaker #5: Thank you, John. On slide 26, in July, we initiated our first in-human 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.

Janet Hammond: Thank you, John. On slide 26, in July, we initiated our first-in-human 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, and with dose progression informed by real-time safety and PK review. We have recently completed the first cohort and are moving forward to the next cohort. Hepatitis E has no approved therapy, so this is a potential first-in-class opportunity that provides a meaningful pipeline program beyond Hepatitis C. I am going to turn the call over now to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials.

Speaker #5: 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.

Speaker #5: We have recently completed the first cohort, and are moving forward to the next cohort. Hepatitis E has no approved therapy, so this is a potential first-in-class opportunity that provides a meaningful pipeline program beyond hepatitis C.

Speaker #5: I'm going to turn the call over now to Andrea Corcoran, our Chief Financial Officer, to discuss Atea's financials.

Speaker #6: Thanks, Janet. As Jonae mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of 2026.

Andrea Corcoran: Thanks, Janet. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for Q2 2026. The statement of operations and balance sheet can be found on slides 28 and 29. We are pleased to report that our cash and investments balance was $219.5 million at 30 June 2026. The funds we expended in Q2 were principally directed to the advancement of our HCV phase III clinical trials, C-BEYOND and C-FORWARD, and to a lesser extent, to the completion of clinical trial start-up activities for the first-in-human study of AT-587, which Janet just described as our product candidate for the treatment of HEV.

Speaker #6: The statement of operations and balance sheet can be found on slides 28 and 29. We are pleased to report that our cash and investments balance was $219.5 million at June 30, 2026.

Speaker #6: The funds we expended in the second quarter were principally directed to the advancement of our HCV Phase 3 clinical trials, SEE Beyond and SEE Forward, and to a lesser extent to the completion of clinical trial start-up activities for the first-in-human study of AT-587, which Janet just described is our product candidate for the treatment of HEV.

Speaker #6: As we have noted recently, milestone events in each program have been realized, with the announcement of positive top-line results in SEE Beyond, the completion of patient enrollment in SEE Forward, and the initiation of the first-in-human clinical study of AT-527.

Andrea Corcoran: As we have noted recently, milestone events in each program have been realized with the announcement of positive top-line results in C-BEYOND, the completion of patient enrollment in C-FORWARD, and the initiation of the first-in-human clinical study of AT-587. In the first 6 months of 2026, our R&D expenses increased compared to the prior year, principally driven by higher external spend related to the HCV phase III program and incremental HEV preclinical and clinical trial start-up activities. These incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock-based compensation and payroll-related costs. With respect to G&A, there was a decrease in the first 6 months of 2026 compared to the prior year, due principally to lower salaries and lower wages, as well as lower stock-based compensation.

Speaker #6: In the first six months of 2026, our R&D expenses increased compared to the prior year, principally driven by higher external spend related to the HCV Phase 3 program and incremental HEV preclinical and clinical trial startup activities.

Speaker #6: These incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock-based compensation and payroll-related costs. With respect to G&A, there was a decrease in the first six months of 2026 compared to the prior year, due principally to lower salaries and lower wages, as well as lower stock-based compensation.

Speaker #6: During the second half of 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and the value-creating advancement of our HCV and HEV product candidates.

Andrea Corcoran: During H2 2026, we intend to maintain our rigorous financial discipline while remaining laser-focused on execution and value-creating advancement of our HCV and HEV product candidates. As we complete C-FORWARD, prepare to submit our regulatory filings, and engage in pre-launch activities, the substantial majority of our spending will remain focused on the advancement of our Hepatitis C program. With the resources in hand at the end of June, we expect to realize these value-creating milestones for both programs, and we project our cash runway to extend through 2027. I will now hand the call back to Jean-Pierre for closing remarks.

Speaker #6: As we complete see forward, prepared to submit our regulatory filings, and engage in prelaunch activities, the substantial majority of our spending will remain focused on the advancement of our hepatitis C program.

Speaker #6: With the resources in hand at the end of June, we expect to realize these value-creating milestones for both programs, and we project our cash runway to extend through 2027.

Speaker #6: I'll now hand the call back to Jean-Pierre for closing remarks.

Speaker #2: Thank you, Andrea. In closing, on slide 30, our milestones are clear and all near term. We completed patient enrollment for SEE Forward in June, and top-line results are expected in early Q1 2027.

Jean-Pierre Sommadossi: Thank you, Andrea. In closing, on slide 30, our milestones are clear and all near-term. We completed patient enrollment for C-FORWARD in June, and top-line results are expected in early Q1 2027. Pending positive result from C-FORWARD, our NDA submission is anticipated in Q2 2027. In parallel

Speaker #2: Pending positive results from see forward, our NDA submission is anticipated in the second quarter of 2027. In parallel.

Speaker #7: Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty once again. Please remain on the line; we are experiencing a technical difficulty.

Operator 3: Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. We are experiencing a technical difficulty.

Operator: Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. We are experiencing a technical difficulty.

Jean-Pierre Sommadossi: Hello?

Speaker #2: Hello?

Speaker #6: Thank you. JP, you may continue.

Operator 1: Thank you. JP, you may continue.

Operator: Thank you. JP, you may continue.

Jean-Pierre Sommadossi: My apologies. I was disconnected. In parallel, our Hepatitis E program is progressing very well and advancing toward proof of concept in 2027. We believe that bemnifosbuvir potential best-in-class profile, including high efficacy, short treatment duration, a low risk of drug-drug interactions, and no food effect, position us to meaningfully contribute to the goal of HCV eradication in the US and globally. Based on our projection, we expect a short time to profitability after the anticipated mid-2028 launch. We look forward to keeping you updated on our progress. With that, I will now turn the call back over to the operator.

Speaker #2: My apologies. I was disconnected. In parallel, our hepatitis E program is progressing very well and advancing toward proof of concept in 2027.

Speaker #2: We believe that Bandwidth has real potential as a best-in-class profile, including high efficacy, short treatment duration, a low risk of drug-drug interactions, and no food effect.

Speaker #2: Position us to meaningfully contribute to the goal of HCV eradication in the US and globally. Based on our projection, we expect a short time to profitability after the anticipated mid-2028 launch.

Speaker #2: We look forward to keeping you updated on our progress, and with that, I will now turn the call back over to the operator.

Speaker #7: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad.

Operator 3: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from Andy Hsieh with William Blair. Please go ahead.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from Andy Hsieh with William Blair. Please go ahead.

Speaker #7: A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue.

Speaker #7: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we queue up for questions.

Speaker #7: Our first question comes from Andy Shea with William Blair. Please go ahead.

Speaker #5: Great, thanks for taking our questions, and congratulations on the big milestone for the company. So, my first question has to do with labeling.

Andy Hsieh: Great. Thanks for taking our questions, and congratulations on the big milestone for the company. My first question has to do with labeling. I think, JP, you mentioned about the new mechanism of action. I am curious, with the assembly disruption mechanism, how do you get that into the label? That is number one. Number two, it has to do with the test-and-treat model. I think, John, you mentioned about that. You also mentioned about the one-month blister pack. Based on some of the conversations with KOLs, they really like to see a test-and-treat model. On top of that, you basically give all the drugs in one setting. I am just wondering what steps do you have to take to really reach that goal? Thank you so much.

Speaker #5: I think JP, you mentioned about the new mechanism of action. I'm, I'm curious, you know, with the assembly disruption mechanism, how, how do you get that into the label that's number one?

Speaker #5: number two, it has to do with the test and treat model. I think John, you mentioned about that. You'd also mentioned about the one-month blister pack.

Speaker #5: Based on some of the conversations with KOLs, they really like to see a test-and-treat model. On top of that, you basically give all the drugs in one setting.

Speaker #5: And I'm just wondering, what steps do you have to take to, to really reach that goal? Thank you so much.

Speaker #2: Okay. First, Andy, thanks for, you know, the scientific knowledge here. And we have not released yet all the data, and we continue to build upon this new MOA.

Jean-Pierre Sommadossi: Okay. First, Andy, thanks for your scientific knowledge here. We have not released yet all the data. We continue to build upon this new MOA, and we anticipate to share with the FDA early next year when we will have the full data set. It is a little bit early for me to discuss about it, but obviously, we will present at scientific meetings and share with the FDA with the impact that we believe that this supplemental important MOA for them and totally unique. John, you want to address the second question of Andy?

Speaker #2: and we anticipate to share with the FDA early next year when we'll have, the full data set. So it's a little bit, a little bit early for me to, to discuss about it, but obviously, we will present that scientific meetings, and, share with the FDA.

Speaker #2: With the impact that we believe that this supplemental, important MOA for BAM is totally unique. John, do you want to address the second question from Andy?

Speaker #3: Sure, thanks, Andy. Yeah, test and treat is what the KOLs are looking to. They do believe that will actually increase the number of patients that are treated.

John Vavricka: Sure. Thanks, Andy. Yeah. Test and treat is what the KOLs are looking to, what they do believe will actually increase the number of patients that are treated. You are correct that the way that they would like to practice it is the patient is diagnosed and then immediately treated. This is unlike the other products that are out there. So we will have both bottles and for these blister packs. Similar to the other products, you would have to likely give two blister packs out if that is what the patient required or two bottles out. Very similar to what you have going on today. The reason for the blister packs was it was just identified as a more convenient way for the HCV patients, and we are trying to do everything we can to make them take their medication and be more compliant.

Speaker #3: And then you are correct that, the, the way to the way that they would like to practice it is the patient is diagnosed and then immediately treated.

Speaker #3: This is unlike, just like the, the other products that are out there. So we will have both bottles in for these, these blister packs.

Speaker #3: And similar to the other products, you would, you know, if it's, you would have to likely, for, you know, give, you know, give, give, you know, two blister packs out if that's, if that's what the, patient required, or two bottles out.

Speaker #3: Very similar to what you have going on today. The reason for the blister packs was that it was just identified as a more convenient way for the HCV patients.

Speaker #3: And we're trying to do everything we can to make them take their medication and be more compliant. It's just a matter of the quantity that you'll give them at that time.

John Vavricka: It is just a matter of the quantity that you will give them at that time. Does that answer your question, Andy?

Speaker #3: Does that answer your question, Andy?

Speaker #5: y-yeah. So, so I guess the question also has to do with kind of refilling requirements. So after the first month, you know, based on payers or other stakeholders, how basically, how do you eliminate that.

Andy Hsieh: Yeah. I guess the question also has to do with kind of refilling requirements. After the first month, based on payers or other stakeholders, basically how do you eliminate that

John Vavricka: Sure

Speaker #5: Step to, to get a refill?

Andy Hsieh: step to get a refill?

Speaker #3: So, I don't have that answer for you today. What I can tell you is that, in talking with physicians who do practice test and treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount, without a refill, to those patients.

John Vavricka: I do not have that answer for you today. What I can tell you is that in talking with physicians who do practice test and treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount without a refill to those patients, and that would be specific to the programs. You are correct. Where it is existing, they do give them to everyone. Would every physician be able to provide test and treat today? That is part of the challenges and the mechanisms that will have to be worked out. But I can tell you in talking to these physicians who have implemented the test and treat and have provided the treatment at that visit, they do see great promise and great success.

Speaker #3: And that would be specific to the programs. So you are correct, where it is existing, they do give them to everyone. Would every physician be able to, to provide test and treat today?

Speaker #3: That's, that's part of the challenges and the mechanisms that will have to be worked out. But I can tell you, in talking to these physicians who have implemented the test and treat and have provided, the treatment at that visit, they do see great promise and great success.

Speaker #3: the one thing that they are very excited about for our profile is that it really would be the best profile to use in the test and treat because of the, you know, the potential lack of drug-drug interactions and not have to worry about what a patient is either taking now or will be taking.

John Vavricka: The one thing that they are very excited about for our profile is that it really would be the best profile to use in the test and treat because of the potential lack of drug-drug interactions, and not have to worry about what a patient is either taking now or will be taking, and it will offer the shortest course of therapy.

Speaker #3: And it will offer the shortest course of therapy.

Speaker #5: Great. Thanks so much.

Andy Hsieh: Great. Thanks so much.

Speaker #7: Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead.

Operator 3: Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead.

Operator: Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead.

Speaker #8: Hello. this is Yueyue Ang for John. Thanks for taking my question and congrats again. the phase three data. So I'd like to touch, the AASL desimplified treatment algorithm.

Yuanyuan Ang: Hello, this is Yuanyuan Ang for John. Thanks for taking my question, and congrats again on the phase III data. I would like to touch on the AASLD simplified treatment algorithm. Can you walk us through the process and timeline to get the treatment included in the guideline? What evidence do you think will be most important for the panel to see from the C-BEYOND and C-FORWARD results to include them in the treatment algorithm? Thank you.

Yuanyuan He: Hello, this is Yuanyuan Ang for John. Thanks for taking my question, and congrats again on the phase III data. I would like to touch on the AASLD simplified treatment algorithm. Can you walk us through the process and timeline to get the treatment included in the guideline? What evidence do you think will be most important for the panel to see from the C-BEYOND and C-FORWARD results to include them in the treatment algorithm? Thank you.

Speaker #8: So can you walk us through the process and timeline to get the treatment included in the guideline and, what evidence do you think will be most important for the panel to see from the CBI and C4 results to, include them in the, treatment algorithm?

Speaker #8: Thank you.

Speaker #2: All right, sir. You want to address that?

Jean-Pierre Sommadossi: Loretta, you want to address that?

Speaker #8: Sure. I think what they are looking for is a best-in-class profile. So, this is what we are offering here. It's patients. And, you know, once they see these results and we obviously get a label and an approval, I think it will not be difficult with this profile to get it into treatment algorithms.

Arantxa Horga: Sure. I think what they are looking for is best-in-class profile. This is what we are offering here. It is the 8-week for the majority of the patients. Once they see these results, and we obviously get a label and an approval, I think that it will not be difficult with this profile to get it into treatment algorithms and have it prescribed by physicians. We are hearing really excellent feedback from our PIs.

Speaker #8: and, you know, have it prescribed by physicians. We're, we're hearing really excellent feedback from our PIs. Okay. Thank you.

Yuanyuan Ang: Okay. Thank you.

Yuanyuan He: Okay. Thank you.

Speaker #2: Let's stay on just one to add one point is that for both the North American trial and the, C4 also in 17 countries, it's, it's absolutely remarkable that we were able to fully enroll, about 900 patients are in less than eight months.

Jean-Pierre Sommadossi: I think I just want to add one point, is that for both the North American trial and the C-FORWARD, so in 17 countries, it is absolutely remarkable that we were able to fully enroll about 900 patients in less than 8 months. With 120 clinical sites, with a high demand. We could see at the end that the demand was growing exponentially, and we had actually to, unfortunately, stop because we could not go beyond much more in term of the number of targeted patients. But there was really a high demand for this clinical trial in both North America, the US, as well as in these 17 countries. Next question, please.

Speaker #2: so, with 120 clinical sites. with, a high demand. and we can see at the end that the demand was going exponentially. And we are actually to, unfortunately, stop because we could not go beyond, much more in term of the number of targeted patients.

Speaker #2: But there was really a high demand for this clinical trial, in both North America—the US—as well as in these 17 countries. Next question, please.

Speaker #8: Okay. Thank you.

Yuanyuan Ang: Thank you.

Yuanyuan He: Thank you.

Speaker #7: Our next question comes from Maxwell Score with Morgan Stanley. Please go ahead.

Operator 3: Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead.

Operator: Our next question comes from Maxwell Skor with Morgan Stanley. Please go ahead.

Speaker #2: Great, thank you very much for taking my question, and congrats on the update. Regarding the non-inferiority, which also cleared on the per-protocol secondary in CBI, which is the C4 primary endpoint for the EMA, how much does that lift your confidence going into the early Q1 2027 readout?

Maxwell Skor: Great. Thank you very much for taking my question, and congrats on the update. Regarding the non-inferiority, which also cleared on the per-protocol secondary in C-BEYOND, which is the C-FORWARD's primary endpoint for the EMA. How much does that lift your confidence going into the early Q2 2027 readout? Also, how comparable do you expect the baseline characteristics to be across the two studies, given C-FORWARD's different geographies and genotype mix?

Speaker #2: Also, how comparable do you expect the baseline characteristics to be across the two studies given C4's different geographies and genotype mix? And finally, if I can ask just one more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B, and how they're reshaping the competitive landscape.

Maxwell Skor: Finally, if I can ask just one more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B, and how they're reshaping the competitive landscape. Thank you.

Speaker #2: Thank you. great question. our answer, you want to, tackle that, we are going to basically, report that, scientific meeting. But, we do not worry.

Jean-Pierre Sommadossi: Sure, Max. Great question. Arantxa, you want to tackle? We are going to basically report that at scientific meeting, but we do not worry. Obviously, we always worry, but we do not worry on the per protocol. As you have seen, it is quite a bit of discontinuation, but we have sufficient power. Why do not, Arantxa, you chime in as well and address the difference of patients, which actually it is substantial. Arantxa, can you go ahead?

Speaker #2: Obviously, we always worry. But we do not worry on the per-protocol. As you have seen, it's quite a bit of discontinuation. But we are sufficiently powered.

Speaker #2: So, what, why don't our answer, you chime in as well and, and, address, the difference of patients, which actually it is, substantial. Our answer, can you go ahead?

Speaker #8: Yes. I think, Max—I mean, it's a great question. So for the C4, we are more likely to see genotypes, obviously, that are not in the United States.

Arantxa Horga: Yes. I think, Max, it is a great question. For the C-FORWARD, we are more likely to see genotypes, obviously, that are not in the United States. The United States predominantly is 1a. Ex-US, we are going to be seeing more of the 1bs, and then some of the rare genotypes that we made an extraordinary effort to get are genotypes 6, 5, which are not common in the United States. It will differ in terms of genotypes, but I want to remind you that a lot of these genotypes we already treated in phase II, where we had genotype 3 in particular, excellent results.

Speaker #8: So the United States predominantly is 1A. XUS, we're gonna be seeing more of the 1Bs. and then some of the rare genotypes, that we made a, an extraordinary effort to get, genotypes, 6, 5, which are not common in the United States.

Speaker #8: And so it will, it will differ in terms of genotypes. But I wanna remind you that a lot of these genotypes we already treated in phase two, where we had, genotype three in particular, excellent results.

Speaker #8: In terms of the population, we think we'll see probably less transmission through IV drug use, you know, that kind of population that we also saw in the Phase II, because globally there is still quite a lot of transmission through things like dental procedures, transplants, and even blood transfusions.

Arantxa Horga: In terms of the population, we think we will see probably less transmission through the IV drug use, that kind of population that we also saw in the phase II, because globally, there is still quite a lot of transmission through things like dental procedures, transplants, even blood transfusions. The population ex-US in general tends to report less frequently adverse events. They tend to be less lost to follow-up. They tend to be a little more compliant with the protocol. If anything, we think we are going to be seeing a more adherent population, and maybe even a little bit closer to what we saw in the phase II, where we had already excellent results. I think that was your main question for me. There was another one, though.

Speaker #8: and the population XUS in general, tends to report less, frequently adverse events. They, they tend to be less lost to follow-up. They tend to be a little more compliant with the protocol.

Speaker #8: So if anything, we think we're gonna be seeing a more adherent population and maybe even a little bit closer to what we saw in the phase two, where we had already excellent results.

Speaker #8: I think that was your main question for me. There was another one, though.

Speaker #2: Oh, yes. I'm sorry about pricing. for John?

Jean-Pierre Sommadossi: Yes.

Maxwell Skor: Yes.

Jean-Pierre Sommadossi: I am sorry. About pricing for John.

Speaker #3: Sure. So, Ma-Max, I think your question was on pricing before and the various, you know, generous and other legislative 340Bs reshaping the landscape. and you are correct.

John Vavricka: Sure. So, Max, I think your question was on pricing reform and the various generics and other legislatives, 340Bs reshaping the landscape. You are correct, and it depends on what segment that you're more heavily weighted in. Currently, the two products, whether it's MAVYRET or EPCLUSA, have different percentages of their business coming from Medicaid or Medicare. Those changes have already started to take effect. For instance, having a higher percentage of Medicare patients, the Inflation Reduction Act has had an effect on that. In the past, manufacturers weren't responsible for a percentage of the total prescription cost there, and that is happening now. As far as the other things you mentioned, like generics and so forth, which is MFN type pricing and its effect on Medicaid, it could affect the Medicaid discounts that are currently being offered.

Speaker #3: And it depends on, you know, what segment that you're more heavily weighted in. And currently, the two products, whether it's Maverett or Occlusa, have different, percentages of their business coming from Medicaid or, or Medicare.

Speaker #3: and those changes have already started to take to effect. So for instance, having a higher percentage of Medicare patients, the I the inflation reduction axis has had an effect on that v in the past, manufacturers weren't responsible for, a percentage of the of the total prescription cost there.

Speaker #3: And that is happening now. As far as the other things you mentioned, like 'generous' and so forth—which is, you know, MFN-type pricing—and its effect on Medicaid, you know, it could affect the Medicaid discounts.

Speaker #3: but, that are currently being offered. But there's something interesting, Max, and that is when you start looking at the pricing differential between the US, for instance, and a lot of these generous or ma-mainly, EU countries or Western countries, the pricing isn't as, dramatically different from the US as, as other types of pharmaceutical products.

John Vavricka: But there's something interesting, Max, and that is when you start looking at the pricing differential between the US, for instance, and a lot of these generics or mainly EU countries or Western countries, the pricing isn't as dramatically different from the US as other types of pharmaceutical products, and we were kind of shocked at that. The impact will not be as dramatic as some people think. The other thing to bear in mind is that some manufacturers are already cutting direct deals with individual state Medicaid agencies beyond the statutory discounts to be provided. From that standpoint, the difference between the extra rebates that they're already providing and what the generics or the extra rebates for MFN might be could theoretically be smaller. But that's what we know now. The other last thing you mentioned was 340B.

Speaker #3: And we were, you know, kind of shocked at that. So the impact will not be as dramatic as some people think. The other thing to bear in mind is that some manufacturers are already cutting direct deals with individual state Medicaid agencies, beyond the statutory discounts to be provided.

Speaker #3: From a standpoint, the difference between the extra rebates that they're already providing and what the generous or the extra rebates for MFN might be, could theoretically be smaller.

Speaker #3: But that's what we know now. The other last thing you mentioned was 340B. I think the, the proposed legislative or the administrative changes that are happening for 340B, I think, will be favorable, to the, to the manufacturers in the sense that, you know, if, if the current thinking goes through instead of providing an outright discounted price, that it would be handled through a rebate mechanism.

John Vavricka: I think the proposed legislative or the administrative changes that are happening for 340B will be favorable to the manufacturers in the sense that if the current thinking goes through, instead of providing an outright discounted price, it would be handled through a rebate mechanism, thus allowing the manufacturers to make sure that they're not getting double counted on both Medicaid and 340B. We'll have to stay tuned to see what happens with that.

Speaker #3: Thus allowing the manufacturers to make sure that they're not getting double-counted on both Medicaid and 340B. But so, we'll have to stay tuned to see what happens with that.

Speaker #2: thanks, John. I wanna.

Jean-Pierre Sommadossi: Thanks, John.

Maxwell Skor: Great. Thank you very much.

Speaker #5: Great. Thank you very much.

Speaker #2: Go back. I went, Max, I went to go back just to make sure that there is no misunderstanding C4, the per-protocol is the primary endpoint, for the EMA.

Jean-Pierre Sommadossi: Max, I want to go back just to make sure that there is no misunderstanding here. On the C-FORWARD, the per protocol is the primary endpoint for the EMA. For the FDA, the MITT is the primary endpoint, okay? Please be aware that the MITT as the C-BEYOND for C-FORWARD, the primary endpoint for the FDA will be the MITT. Essentially, we will have two primary endpoints in the C-FORWARD. I hope that-

Speaker #2: But for the FDA, the MITT is the primary endpoint. Okay? So, please be aware that the M-MITT, as the CBR for C4, the primary endpoint for the M for the FDA will be the MITT.

Speaker #2: So essentially, we will have two primary endpoints in the C4. I hope that.

Speaker #5: Okay.

Maxwell Skor: Okay.

Speaker #2: Just to make sure.

Maxwell Skor: Just to make sure that-

Jean-Pierre Sommadossi: Just to make sure that-

Maxwell Skor: Very helpful. Thank you for clarifying. Appreciate it. Thanks.

Speaker #5: Very helpful. Thank you very thank you for clarifying. Appreciate it. Thanks.

Speaker #2: Okay, very good. Thank you, Max. Any other questions? So, thank you all for joining our second quarter conference call, and thank you for your continued support.

Jean-Pierre Sommadossi: Okay. Very good. Thank you, Max. Are there any other questions? Thank you all for joining our Q2 conference call, and thank you for your continued support.

Speaker #1: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator 3: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Jean-Pierre Sommadossi: Thank you.