AVIR - NASDAQ

Good afternoon, and welcome to the Atea Pharmaceuticals' Second Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Jonae Barnes, Senior Vice President, Investor Relations and Corporate Communications. Please go ahead.

Great. Thank you, and good afternoon, everyone, and welcome to Atea Pharmaceuticals' Second Quarter 2025 Financial Results and Business Update Conference Call. Earlier today, we issued a press release, which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our website at ir.ateapharma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet Hammond; John Vavricka, our Chief Commercial Officer; Dr. Arantxa Horga, our Chief Medical Officer; and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, all of whom 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. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.

Thank you, Jonae. Good afternoon, everyone. Thank you for joining us. I will begin on Slide 3. For the second quarter, we have several clinical and business highlights to review. We made important progress in our HCV program, evaluating the potential best- in-class regimen of bemnifosbuvir and ruzasvir. We started dosing patients in our global Phase III development program, which is comprised of the two trials, C-BEYOND in the U.S. and Canada and C-FORWARD outside of North America. At EASL in May, we presented the final results from our global Phase II trial. These results demonstrated a 98% cure rate in the primary efficacy analysis with a short 8-week treatment. The very high sustained virologic response, which we refer as SVR or cure rate, demonstrated a robust potency across HCV genotypes. We also presented three Phase I studies, and Arantxa will review the highlights of these presentations in a few moments. Also in May, we hosted a key opinion leader event for investors featuring a panel of six HCV experts and prescribers. Leaders in hepatology, gastroenterology infectious disease and HCV research in the U.S., Canada and Europe discussed the current challenges experienced by people living with HCV and what a new optimized HCV therapy could provide for prescriber and patients. Janet will review the key takeaway from this event later in this call. In addition to this substantial clinical progress, we have taken steps to further enhance shareholder value. In April, we announced the repurchase of up to $25 million of the company common stock, reflecting the company commitment to return capital to shareholders while maintaining the capacity to complete the global Phase III HCV program and position Atea for long-term success. We also announced the addition of a new independent director, Dr. Howard Berman, who has over 20 years of entrepreneurial and life science industry experience. We continue as well to explore potential opportunities to enhance shareholder values. Moving to Slide 4. It has been nearly a decade since the last generation of HCV therapy became available to patients. Since then, patients and the treatment needs have evolved, and we are focused on the successful development of a potential best-in-class regimen to treat and cure today's HCV patients. During the second quarter, we continued to advance our global Phase III HCV program, evaluating the regimen of bemnifosbuvir and ruzasvir. The patient enrollment is on track, and I'm pleased to share with you today. And we anticipate top line results from C-BEYOND is mid-2026 and C-FORWARD at the end of 2026, which is due to longer time lines outside of North America for regulatory approvals of clinical trials. Our regimen, if approved, has the potential to become a best-in-class HCV treatment and disrupt the global HCV market, which is approximately $3 billion in annual net sales. With $379.7 million in cash, cash equivalents and marketable securities as of June 30, 2025, we are in a strong financial position to execute and complete our Phase III HCV program, and we anticipate our cash runway will extend through 2027. Moving to Slide 5. HCV remains a significant global healthcare issue with an increasing incidents of infections despite the availability of direct-acting antiviral for the past decade. Currently, in the U.S., out of the 170,000 new infections, only approximately 100,000 patients are treated annually. The unrelenting high rate of HCV infection, which is outpacing the stagnant number of patients being treated underscore the need for a new, differentiated and optimized therapy. There are between 2.4 million and 4 million untreated people infected with HCV in the United States. And let's not forget that in the U.S. as in developed countries, 70% of liver cancer diagnosis result from HCV disease progression. Therefore, low treatment and cure rate for HCV patients have a profound impact not only on patients' life, but also on the associated healthcare costs in the near future. On Slide 6. The large burden of untreated HCV disease is also a large untapped commercial opportunity. We believe that the best- in-class profile of our regimen, which is particularly well suited for a new model of care, which we call test and treat, with seamless diagnosis and treatment for patients infected with HCV, the anticipated remodel of access Axis Bio and future government initiative we see today arising from the hill can dramatically expand the number of patients cured of this severe viral disease. With that, I will now turn the call over to Arantxa Horga, who will review the presentations at EASL and our Phase III program. Arantxa?

Thank you, Jean-Pierre. Let's move to Slide 8. In May, at the European Association for the Study of the Liver Congress or EASL, four Atea posters were presented. They included the results from the full cohort of patients enrolled in the Phase II study, evaluating the regimen of bemnifosbuvir and ruzasvir for HCV, which are highlighted in the coming slides. In addition, results from three additional Phase I studies demonstrated that the combination of bemnifosbuvir and ruzasvir had a low risk of drug-drug interactions. These results support the use of the regimen in HCV patients co-infected with HIV, taking a standard HIV treatment. Also presented was the PK and safety of bemnifosbuvir in participants with hepatic or renal impairment, showing no need for dose adjustments. The EASL posters presented can be accessed on the Atea website in the Publications section. Let's now review the highlights from the Phase II results. On Slide 9, to the left, you will see the overview of our global Phase II study, which was a single-arm trial of 550 milligrams of bemnifosbuvir with 180 milligrams of ruzasvir once daily for 8 weeks. We enrolled 275 treatment-naive patients chronically infected with HCV, including patients with compensated cirrhosis. In the study, we evaluated two efficacy populations. The primary efficacy endpoint was in the treatment-adherent population. Secondary efficacy analysis assessed SVR12 in the same population, but it also included non-adherent patients. To the right, the primary efficacy endpoint demonstrates a 98% SVR12 rate in all adherent patients after 8 weeks of treatment and a 95% SVR12 rate was achieved in patients regardless of treatment adherence, with 20% of these patients being non-adherent. Slide 10 shows that in the overall non-cirrhotic treatment-adherent population, SVR12 was almost 100% with only one failure out of 179 patients. In genotype 3, SVR12 was 100%, which is a genotype that is historically hard to treat. The robust potency and drug forgiveness was demonstrated in non-cirrhotic patients regardless of drug adherence with the regimen achieving 97% SVR12 in the overall population and 98% in genotype 3. The regimen was generally safe and well tolerated with no drug-related severe adverse events or premature treatment discontinuations. Similarly, there were no trends observed in adverse events or safety laboratory parameters. On Slide 12 is an overview of Atea's global HCV Phase III program, which includes two open-label Phase III trials, C-BEYOND and C-FORWARD. Each Phase III trial is enrolling approximately 880 treatment-naive patients, including those with and without compensated cirrhosis. The trials will compare the fixed-dose combination regimen of bemnifosbuvir and ruzasvir to the fixed- dose regimen of sofosbuvir and velpatasvir, also known as EPCLUSA. Our 2-pill regimen will be administered orally once daily for 8 weeks in non-cirrhotic patients or 12 weeks in patients with compensated cirrhosis, while sofosbuvir and velpatasvir will be administered orally once daily for 12 weeks to all patients with or without compensated cirrhosis. The primary endpoint measures cure by using the regulatory-approved endpoint of SVR12. Measurement occurs at 24 weeks from the start of treatment to ensure the primary endpoint occurs at the same relative time point for all patients. As Jean-Pierre mentioned earlier, patient enrollment is on track. Slide 13 shows the geographic footprint for C-BEYOND with approximately 120 clinical sites in the U.S. and Canada. For C-FORWARD, we're targeting approximately 120 clinical sites in 16 countries outside of North America. I will now hand the call over to Janet Hammond to review our recent KOL event and the profile of our regimen. Janet?

Thank you, Arantxa. Good afternoon, everybody. Let's now move to Slide 15. Following EASL, Atea held a hepatitis C key opinion leader event that featured a panel of six leaders in hepatology, gastroenterology, infectious disease and HCV research from the U.S., Canada and Europe. During the panel discussion, these experts discussed the current challenges encountered by patients with hepatitis C and their providers and what a new optimized hepatitis C therapy could offer. In addition, the results from Atea's global Phase II study evaluating the regimen of bemnifosbuvir and ruzasvir for the treatment of hepatitis C were presented by Dr. Eric Lawitz, from the Texas Liver Institute, University of Texas Health, San Antonio, who was an investigator in the Phase II study and is also an investigator in the Phase III C-BEYOND trial. On Slide 16, you will see some of the key takeaways from the panel discussion. Please note that the panel discussion replay information is also available on these slides. The key opinion leaders noted that the incidence of hepatitis C has not slowed down even with available existing direct-acting antiviral treatments available. In 2015, there were approximately 2.5 million people infected in the United States, and it is now estimated to be upwards of approximately 4 million. The key opinion leaders discussed the evolution in the profile of patients infected with hepatitis C today. Generally, patients now are younger and more medically complex. There has been a shift to younger patients who inject drugs with associated risks of transmission, and this problem is only getting worse. Today, more frequently, patients are also on multiple concomitant medications. Today's patients and healthcare providers want simplicity from their treatment options, including short durations of treatment that are optimized while minimizing interactions with concurrent medications. In addition, the test and treat model of care, which enables seamless diagnosis and treatment for patients infected with hepatitis C was discussed by the key opinion leaders as a necessary change to meaningfully advance the eradication of hepatitis C. The KOLs further stated that neither currently approved regimen is perfect, and there is a need for a new optimized treatment. Let's now move to Slide 17 and review the target profile of our potential best-in-class regimen. It's the only regimen that combines the required attributes to successfully treat today's patients. Our regimen combines bemnifosbuvir, which is the most potent nucleotide for hepatitis C yet to have been developed and ruzasvir, which is a highly potent HCV-NS5A inhibitor. This regimen is significantly differentiated from the approved treatment. It offers a highly potent pan-genotypic therapy with a short treatment duration, along with a low potential for drug-drug interactions and can be taken with or without food. All these attributes address the needs of both prescriber and the patient. Slide 18. Our regimen has a low risk for drug interaction profile. Since approximately 80% of hepatitis C patients are taking concomitant medications, the drug interaction profile of HCV therapies is of particular importance to both patients and prescribers for ease of use. As detailed on this slide, the regimen of bemnifosbuvir and ruzasvir has a very clean drug interaction profile with commonly prescribed medications such as oral contraceptives, statins and proton pump inhibitors. With that, I'll now turn the call over to John Vavricka to review new results from market research. John?

Thank you, Janet. On Slide 20, following the Phase II clinical results, we conducted a quantitative market research study of high U.S. DAA prescribers. IQVIA selected the study participants and conducted the market research. 153 top U.S. DAA prescribers reviewed the BEM/R

Thank you, John. As Jonae mentioned, earlier today, we issued a press release containing our financial results for the second quarter of 2025. The statement of operations and balance sheet are on Slides 23 and 24. In the second quarter of 2025, R&D expenses decreased compared to the same period in 2024. In Q2 2024, we were still conducting our Phase III SUNRISE-3 trial before it concluded later in the 2024 year. For G&A expenses, in comparison to second quarter 2024 G&A expenses, our 2025 G&A expenses decreased primarily as a result of lower stock-based compensation and payroll expenses. Interest income in Q2 2025 was lower than the second quarter of 2024 due to lower investment balances. For the remainder of '25, we expect our R&D expenditures will be principally invested in the conduct of our global Phase III HCV program. As Jean-Pierre mentioned, at the end of the second quarter, our cash, cash equivalent and marketable securities balance was $379.7 million. Continuing our strong financial discipline, we project this cash guidance runway through 2027. Turning to Slide 25. I would like to now review certain Q2 business and organizational highlights. In April, we announced the repurchase of up to $25 million of the company's common stock. This initiative reflects the company's commitment to return capital to shareholders while maintaining the capacity to complete its global Phase III HCV program and to position Atea for long-term success. As of June 30, we had repurchased and retired 4.6 million shares of Atea common stock. During Q2, we also announced the refreshment of our Board with the addition of Dr. Howard Berman as an Independent Director. Dr. Berman has over 20 years of entrepreneurial and life science industry experience, working at the interplay of science and business. I'll now hand the call back to Jean-Pierre for closing remarks.

Thank you, Andrea. In closing, we believe that our global Phase III HCV program is derisked with a highly compelling value proposition. This is based on substantial preclinical and clinical data, a well-characterized regulatory pathway, optimized manufacturing processes, a durable multibillion-dollar market and a long patent runway. We believe that the regimen of bemnifosbuvir and ruzasvir with its potential best-in-class profile for the treatment of HCV, if approved, provides an opportunity to become the most prescribed treatment, disrupting and expanding the current global HCV market of approximately $3 billion in annual net sales. Before opening the call to your questions, I would like to thank our talented and dedicated Atea employees. Our team's relentless pursuit of excellence drives our dedication to advancing oral antiviral therapeutics for patients worldwide affected by severe viral disease. With that, I will turn the call back over to the operator.

[Operator Instructions] The first question comes from Andy Hsieh with William Blair.

This is Kelsey Lucerne, William Blair on for Andy Hsieh. Very curious, could you provide an update on how enrollment is progressing in the Phase III C-BEYOND and C-FORWARD trials? And what kind of feedback or enthusiasm you might be hearing from investigators so far?

Arantxa?

Yes. Thank you for the question. So enrollment is progressing on track. And C-BEYOND in particular, is, as you know, moving a little faster because the regulatory approvals are faster in North America as compared to C-FORWARD, where the regulatory approvals take longer in a lot of these countries. But in both cases, is on track. And in terms of the investigator enthusiasm, I have to say that having done this for many years now, studies that enroll on track and are doing well with enrollment always reflect keen interest from the investigators and a very nice value proposition for the patients. And that's why they sign up and that's why you enroll and you're not behind. So I think our enrollment is reflecting exactly the enthusiasm from investigators and from the patients.

This concludes our question-and-answer session. I would like to turn the conference back over to J.P. Sommadossi for any closing remarks.

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