Q2 2025 Atea Pharmaceuticals Inc Earnings Call

Speaker #4: Good afternoon and welcome to the Atea Pharmaceuticals second quarter 2025 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad.

Speaker #4: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad.

Speaker #4: To withdraw your question, please press star then two. 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.

Speaker #4: Please go ahead.

Speaker #5: Great. Thank you. And good noon, 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.

Speaker #5: You can access the press release as well as the slides that will be reviewing today by going to the investor section of our website at ir dot ateapharma dot com.

Speaker #5: With me today from Atea are our chief executive officer and founder, Dr. Jan-Pierre Sommadossi. Chief development officer, Dr. Janet Hammond. John Vavricka, our chief commercial officer.

Speaker #5: Dr. Aranja Horga, our ief 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.

Speaker #5: Before we begin the call, and as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainties.

Speaker #5: 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.

Speaker #5: Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jan-Pierre.

Speaker #6: Thank you, Jonae. Good afternoon, everyone. Thank you for joining us. I would begin on slide three. For the second quarter, we have several critical and business highlights to review.

Speaker #6: We made important progress in our HCV program, evaluating the potential best-in-class regimen. Our manufacturing and resilience. We started dosing patients in our global phase three development program, which is comprised of the two trials, CBR in the US and Canada, and C forward outside of North America.

Speaker #6: At Easel in May, we presented the final results from our global phase two trial. These results demonstrated a 98% Q rate in the primary efficacy analysis with a short eight-week treatment.

Speaker #6: The very high sustained biological response, which we refer to as SBR or Q rate, demonstrated a robust potency across HCV genotypes. We also presented three Phase 1 studies, and our answer will review the highlights of this presentation in a few moments.

Speaker #6: Also in May, we answered 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 US, 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.

Speaker #6: 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.

Speaker #6: In April, we announced the repurchase of up to $25 million of the company common stock, reflecting the company's commitment to return capital to shareholders who are maintaining the capacity to complete the global phase three HCV program and position Atea for long-term success.

Speaker #6: 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.

Speaker #6: We continue as well to explore potential opportunities to enhance shareholder values. Moving to slide four, it has been nearly a decade since the last generation of HCV therapy became available to patients.

Speaker #6: Since then, patients and the treatment needs have evolved. And we have focused on the successful development of a potential best-in-class regimen to treat and cure today's HCV patients.

Speaker #6: During the second quarter, we continue to advance our global Phase 3 HCV program, evaluating the regimen of manufacturing resilience. Patient involvement is on track, and I am pleased to share with you tonight that we anticipate top-line results from CBR in mid-2026 and C forward at the end of 2026, which is due to longer timelines outside of North America for regulatory approvals of clinical trials.

Speaker #6: Our regimen if approved as the potential to become a best-in-class HCV treatment and disrupt the global HCV market, which is approximately $3 billion in annual death cells.

Speaker #6: With 379 point 7 million dollars in cash, cash equivalent, and marketable securities as of June 30th, 2025, we are in the strong financial position to execute and complete our phase three HCV program.

Speaker #6: And we anticipate our cash runway would extend to 2027. Moving to slide five, HCV remains a significant global healthcare issue with an increasing incidence of infections despite the availability of direct-acting antiviral for the past decade.

Speaker #6: Currently, in the US, out of the 170,000 new infections, only approximately 100,000 patients are treated annually. The unrelenting high rate of HCV infections, which is outpacing the stagnant numbers of patients being treated underscore the need for new, differentiated, and optimized therapy.

Speaker #6: There are between 2.4 and 4 million untreated people infected with HCV in the United States. And let's not forget that in the US, as in developed countries, 70% of liver cancer diagnosis results from HCV disease progression.

Speaker #6: Therefore, low treatment and curate for HCV patients have a profound impact not only on patients' lives, but also on the associated healthcare costs in the near future.

Speaker #6: On slide six, 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 patient infected with HCV, the anticipated remodel of access barrier, and future government initiative are we see today are arising from the hill can dramatically expand the number of patients cured of this severe viral disease.

Speaker #6: With that, I would now turn the call over to Aranja Horga, who will review the presentations at Easel and our phase three program. Aranja?

Speaker #7: Thank you, Jan-Pierre. Let's move to slide eight. In May, at the European Association for the Study of the Liver Congress, or EASO, four Atea posters were presented.

Speaker #7: They included the results from the full cohort of patients enrolled in the Phase 2 study, evaluating the regimen of manifosphovir and rucesvir for HCV, which are highlighted in the coming slides.

Speaker #7: In addition, results from three additional phase one studies demonstrated that the combination of manifosphovir and rucesvir 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.

Speaker #7: Also presented were the PK and safety of manifosphovir in participants with hepatic or renal impairment, showing no need for dose adjustments. The EASO posters presented can be accessed on the Atea website in the publication section.

Speaker #7: Let's now review the highlights from the phase two results. On slide nine, to the left, you will see the overview of our global phase two study, which was a single arm trial of 550 milligrams of manifosphovir with 180 milligrams of rucesvir, once daily for eight weeks.

Speaker #7: 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, a secondary efficacy analysis assessed SBR12 in the same population.

Speaker #7: But it also included non-adherent patients. To the right, the primary efficacy endpoint demonstrates a 98% SBR12 rate in all adherent patients after eight weeks of treatment, and a 95% SBR12 rate was achieved in patients regardless of treatment adherence.

Speaker #7: With 20% of these patients being non-adherent. Slide 10 shows that in the overall non-cirrhotic treatment-adherent population, SBR12 was almost 100%, with only one failure out of 179 patients.

Speaker #7: In genotype three, SBR12 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% SBR12 in the overall population and 98% in genotype three.

Speaker #7: 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.

Speaker #7: On slide 12, is an overview of Atea's global HCV phase three program, which includes two open label phase three trials. CB1 and C forward.

Speaker #7: Each phase three 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 manifosphovir and rucesvir to the fixed dose regimen of sulfosphovir and valpatasvir also known as Epclusa.

Speaker #7: Two imry. Our two-peel regimen will be administered orally, once daily for eight weeks in non-cirrhotic patients or 12 weeks in patients with compensated cirrhosis.

Speaker #7: While sulfosphovir and valpatasvir will be administered orally once daily for 12 weeks to all patients with or without compensated cirrhosis. The primary endpoint measures cure.

Speaker #7: By using the regulatory approved endpoint of SBR12. Measurements occur at 24 weeks from the start of treatment to ensure the primary endpoint occurs at the same relative time point for all patients.

Speaker #7: As Jan-Pierre mentioned earlier, patient enrollment is on track. Slide 13 shows the geographic footprint for CB1 with approximately 120 clinical sites the US and Canada.

Speaker #7: 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.

Speaker #7: Janet?

Speaker #8: Thank you, Aranja. Good afternoon, everybody. Let's now move to slide 15. Following Easel, 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 US, Canada, and Europe.

Speaker #8: During the panel discussion, these experts discussed the current challenges encountered by patients with hepatitis C and their providers, and fought a new optimized hepatitis C therapy could offer.

Speaker #8: In addition, the results from Atea's global phase two study evaluating the regimen of manifosphovir and rucesvir 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 two study and is also an investigator in the phase three CB1 trial.

Speaker #8: 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.

Speaker #8: The key opinion leaders noted that the incidence of hepatitis C has not slowed down even with available existing direct-acting antivirals treatments available. In 2015, there were approximately two and a half million people infected in the United States.

Speaker #8: And it is now estimated to be upwards of approximately four million. The key opinion leaders discussed the evolution in the profile of patients infected with hepatitis C today.

Speaker #8: 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.

Speaker #8: And this problem is only getting worse. Today, more frequently, patients are also on multiple concomitant medications. Today's patients in healthcare providers want simplicity from their treatment options including short durations of treatment that are optimized while minimizing interactions with concurrent medications.

Speaker #8: 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.

Speaker #8: 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.

Speaker #8: 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 manifosphovir, which is the most potent nucleotide for hepatitis C yet to have been developed, and rucesvir, which is a highly potent HCV NS5A inhibitor.

Speaker #8: 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 ithout food.

Speaker #8: 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 use.

Speaker #8: As detailed on this slide, the regimen of manifosphovir and rucesvir has very keen drug interaction profile with commonly prescribed medications such as oral contraceptives, statins, and proton pump inhibitors.

Speaker #8: With that, I'll now turn the call over to Jan Vavricka, to review new results from market research. Jan?

Speaker #9: Thank you, Janet. On slide 20, following the phase two clinical results, we conducted a quantitative market research study of high USDA prescribers. IQVIA selected the study participants and conducted the market research.

Speaker #9: 153 top USDA prescribers reviewed the BAMRZR profile. Including the phase two results, on their own, prior to assessing their likely prescribing. The study revealed high preference for BAMRZR, with 76% extremely likely to prescribe our regimen.

Speaker #9: One asked about the percentage their patients they would likely prescribe BAMRZR to. The study showed that BAMRZR would be used at approximately half their patients.

Speaker #9: The results were similar for both non-cirrhotic and compensated cirrhotic patients. Moving on to slide 21, I would like to highlight that these latest quantitative market research results were conducted following the BAMRZR Phase 2 results.

Speaker #9: Our consistent with the previous quantitative market research conducted over the past two years. The three market research studies consistently show significant preference for BAMRZR, with high USDA prescribers.

Speaker #9: I'll now turn the call over to Andrea to discuss Atea's financials. Andrea?

Speaker #10: Thank you, Jan. 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.

Speaker #10: 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 three sunrise three trial, before concluded later in the 2024 year.

Speaker #10: 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.

Speaker #10: 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 three HCV program.

Speaker #10: As Jan-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.

Speaker #10: 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.

Speaker #10: This initiative reflects the company's commitment to return capital to shareholders while maintaining the capacity to complete its global phase three HCV program and to position Atea for long-term success.

Speaker #10: As of June 30th, we had repurchased and retired $4.6 million shares of Atea common stock. During Q2, we also announced three freshmen of our board with the addition of Dr. Howard Berman as an independent director.

Speaker #10: 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 Jan-Pierre for closing remarks.

Speaker #6: Thank you, Andrea. In closing, we believe that our global phase three HCV program is de-risked 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 multi-billion dollar market, and a long pattern runway.

Speaker #6: We believe that the regimen of manifosphovir and rucesvir with its potential best-in-class profile for the treatment of HCV, if approved, provides an opportunity to become the most prescribed treatment.

Speaker #6: Disrupting and expanding the current global HCV market of approximately $3 billion in annual death cells. Before opening the call to your questions, I would like to thank our talented and dedicated Atea employees.

Speaker #6: Our team relentless pursuit of excellence drives our dedication to advancing oral antiviral therapeutics for patients worldwide affected by severe viral disease. With that, I would turn the call back over to the operator.

Speaker #4: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If ou are using a speakerphone, please pick up your handset before pressing the keys.

Speaker #4: If at any time your question has been addressed and you would like withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.

Speaker #4: The first question comes from Andy Shay with William Blair. Please go ahead.

Speaker #11: Hi. This is Kelsey Luther and William Blair. on for Andy Shay. Thanks for taking my question. we're curious, could you provide an update on how enrollment is progressing in the phase three CB1 and C4 trials and what kind feedback or enthusiasm you might be hearing from investigators so far?

Speaker #11: Thanks.

Speaker #12: Aranja?

Speaker #7: Yes. Thank you for the question. So, enrollment is progressing on track. and, CB1 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.

Speaker #7: but in both cases, it's, it's, it's on track. And in terms of the investigator enthusiasm, I have to say that, you know, having done this for many years now, studies that are enrolled, that enroll on track and are doing well with enrollment, always reflect, keen interest from the investigators and, and a very, nice value proposition, for the patients.

Speaker #7: And that's why they sign up and that's why you enroll, and you're not behind. so I ink, our enrollment is reflecting exactly that, the enthusiasm from investigators and from the patients.

Speaker #4: And did you have a follow-up question?

Speaker #11: no. Thank you so much. Appreciate .

Speaker #6: Thank you.

Speaker #4: This concludes our estion and answer session. I would like to turn the conference back over to JP Sommadossi for any closing remarks.

Speaker #13: thank you all for joining our second quarter earnings conference call. And, and thank you again for your continuous support.