Q4 2024 Atea Pharmaceuticals Inc Earnings Call
Eric Joseph, Timothy Lugo, Maxwell Skor, Jonae Barnes
Good afternoon, everybody, and welcome to Atea Pharmaceuticals' fourth quarter, 2024 Financial Results and Business Update Conference call. At this time, I'll participate in a listen-only mode. Following the formal remarks, we will open the call up for your questions. I would like to hand the call over to Jonae Barnes, Senior Vice President, Investor Relations and Corporate Communications at Atea Pharmaceuticals. Miss Barnes, please proceed.
Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' fourth quarter in full year 2024 financial results in business update conference calls.
Speaker Change: With me today from Atea, our Chief Executive Officer and Founder, Dr. John Piers-Komedosi.
Speaker Change: Chief Development Officer, Dr. Janet Hammond, John Vavricka, our Chief Commercial Officer, Dr. Rancho Horga, Horga, our Chief Medical Officer, and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran. They will all be available for the Q and A tuition of today's call.
Speaker Change: Before we begin the call and is 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 Change: These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Strange 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 John Pierre.
Jean-Pierre: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us.
I would begin on slide three.
Jean-Pierre: We made significant progress last year, advancing our HCV program, which is a regiment of any part of the way on the Rosa's video.
Jean-Pierre: In December , we reported positive results from our global phase 2 trial, which demonstrated the 98% curate in the primary efficacy analysis with a short 8-week treatment.
Jean-Pierre: The very high, as we await, demonstrate the robust potency across HCV Genotypes.
Jean-Pierre: We believe our regiment is approved as the opportunity to become a best-in-class, hepatitis-seed treatment and disrupt the global HCV market of approximately $3 billion in annual net sales.
The very positive face to result.
Jean-Pierre: Alp to support a successful end of phase 2 meeting with the FDA, which occurred this past January , in addition to the substantial progress
that we have.
in addition to the substantial clinical progress.
Jean-Pierre: Business updates include recent stuff. We have taken to further enhance shareholder value.
Jean-Pierre: This includes the retention of Evercore, a global investment bank to assist us in the exploration of strategic partnership related to our Phase 3 HCB program.
Jean-Pierre: We also took coast-cutting actions to enhance efficiency in the management of infrastructure expenditures which Andrea will discuss in further details.
Andrea Corcoran: In February , we announced the appointment of a new independent director, Arthur Kirsch, who brings decades of financial and strategic advisory experience to our Board of Directors.
Moving to slide 4
Andrea Corcoran: Based upon the encouraging results today, together with the successful outcome of the FDA meeting, we are initiating the Global Phase 3 program, evaluating the regimen of Benifaz Vivian, and expect enrollment to begin next month.
Andrea Corcoran: We believe that our Phase 3 program is direct with a compelling value proposition.
furthermore.
Andrea Corcoran: Robots faced two reasons for antiviral therapies of historically led to a high probability of success.
Andrea Corcoran: in Phase 3 Studies. In addition, we would be showing today results from a multi-scale modeling approach that confirms the high likelihood of success of our Phase 3 program.
with $454.7 million of cash.
Andrea Corcoran: Cash equivalent and marketable securities of December 31, 2024. We are in a strong financial position to execute and complete our Phase 3 HCV program. As we anticipate, our cash runway will extend into 2020-28.
Moving to slide five Five.
Andrea Corcoran: H.C.V.s continue to be a significant global healthcare issue despite the availability of direct acting and evolve for the past decade.
The unrelenting high weight of HCV infections.
Andrea Corcoran: which is outpacing the stagnant number of patients being treated, underscored the need for a new, differentiated and optimized therapy.
Andrea Corcoran: I would like to point out that we still have a very large number of untreated HIV patients between 2.4 million in the United States.
Andrea Corcoran: And let's not forget that in the United States, 70% of liver cancer is a consequence of HCV disease progression.
Andrea Corcoran: Therefore, the lack of treatment of these HIV patients has a profound impact not only on patients life, but also with the associated healthcare hospitalization cost.
on slide six.
Andrea Corcoran: The large burden of untreated HCV disease translates into a large and tab commercial opportunity.
Currently in the United States.
Out of the 160,000 new infections every year.
Only approximately 100,000 patients are treated.
Andrea Corcoran: Last year, for example, this US-3D patients resulted in approximately $1.5 billion net sales and globally the market continued to approximate $3 billion.
Andrea Corcoran: We believe that the best in class profile of our regiment together with the anticipated removal of access value and future government initiatives.
Andrea Corcoran: Can dramatically expand the number of patients queuing the United States from this severe viral disease.
Andrea Corcoran: with that. I will now tell the call over to Janet to review the profile of our regiment and the Global Phase 3 program, Janet.
Janet Hammond: Thanks, Jean-Pierre. On slide 7, our potential best-in-class regimen is the only one that combines a required attribute to speak today's ACV patient.
Janet Hammond: Our Regiment Combined Bany Foster Hair, which is the most person here to attach to HDD yes to has been developed, and Rosa's hair, which is a highly person to H3D and H2D in H2D in H2D.
This regimen is differentiated from the approved treatment.
Janet Hammond: It offers a highly pertinent panogenic therapy with a short treatment duration along with potential for drug-breg interaction.
and can be taken with or without food.
Janet Hammond: All these attributes address the needs of the prescriber and the patient.
Janet Hammond: Plagate is a street that only our regiment has a preferred drug-drug interaction profile.
Janet Hammond: With approximately 80% of HCV patients are taking concomitant medications, the drug drug interaction profile of HCV purposes of particular importance to both patients and prescribers for ease of use.
Janet Hammond: As detailed on this slide, the regimen of Ben Fosterware and Rooversware has the cleanest drug drug interaction profile with commonly prescribed medications such as oral contraceptives, medications, and personal pump inhibition.
on slide 10.
Janet Hammond: I'm excited to share an update for our phase 3 program. In January , we have a successful end of phase 2 meeting with the FDA.
Janet Hammond: Following the meeting and that the request of the FDA, we submitted the final phase 3 protocol which also will be submitted to other regulatory agencies.
Janet Hammond: We're currently in the process of opening up clinical sites, and we're targeting over 250 sites 12 wide.
Janet Hammond: as JP stated earlier in the presentation, we're initiating the phase 2 program and expecting enrollment to begin in April .
on slide 11.
Janet Hammond: Our global HCV Phase 3 program tends to have two randomized open label Phase 3 trials, comparing the regimen of Benifosbivir and Ruzizir to the regimen of Tafosbivir and Valpassizir in patients with chronic HCV infection.
Janet Hammond: Each trial will enroll approximately 800 treatment naive patients, both with and without compensated
Patients will be stratified by genotype and cirrhosis patients.
and the patients and patients of HIV co-infection will be allowed.
Janet Hammond: For non-cerotic patients, which represent more than 90% of patients in the U.S., eight weeks of benefits of air and bruises that will be compared with 12 weeks of suffering and
Janet Hammond: A Sirotic Patient, 12 weeks of Benefossive Air and Ruther's Air, will be compared with 12 weeks of Sir Fossive Air and our Patrice Air.
Janet Hammond: The primary endpoint for both trials encompasses the stand virologic response 12 weeks after treatment or FER12 in each arm and is HCV RNA less than the lower limit of quantitation 24 weeks from the start of treatment.
Janet Hammond: Measurement of 24 weeks from the start treatment is selected to ensure the primary endpoint occurs at the same relative time point from start of treatment in all patients.
Arantxa Horga: With that, I'll now turn the call over to Arantra for a review of the Global Phase 2 HDD study results.
Thank you, Jeff.
Thank you very much.
Speaker Change: On slide 12, I would like to remind you that our global taste to study was a single land of 550 milligrams per gram in drop for a year with 180 milligrams of root
Speaker Change: This phase-to-trial enrolled 275 treatment-night patients chronically infected with HCB, including patients with compensated tuberculosis.
Speaker Change: In the study, we had two efficacy populations. The primary efficacy endpoint was in the treatment and adherent population. A secondary efficacy analysis assessed as they are 12 in the same population, but also included nonadientation.
Speaker Change: Of note, we had 17% of patients who did not leave the study medication or were nonadurant in our taste to study, and this nonadurant rate is similar to what was reported in our third party market research.
Speaker Change: Moving to slide 13, the primary efficacy endpoint demonstrates a 98% SVF12 rate in all other
Speaker Change: In this erotic patient, on treatment and bio-kinetics, was slower, but it is important to note
Speaker Change: that 100% by all clearance was achieved at the end of treatment. Therefore, we can expect the 12 weeks of treatment in the erotic patients should lead to very high SVA rate.
Speaker Change: Ply 14 shows that the overall non-syrotic treatment environment population, FDR-12, with almost a hundred percent, with only one failure in 179 patients.
Speaker Change: In January 3, it was 100%, which is a dinner that historically hard to treat.
Speaker Change: The robust potency and drug forgiveness was demonstrated in non-syrotic patients, regardless of drug adherence with the regime in achieving 97% as they are 12 in the overall population and 98% in Genopad 3.
Even with 20% of these patients being none of the earth.
Speaker Change: On slide 15, the regimen of the Nephosphobirangosa severe was generally save and were 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 Change: to confirm defectiveness of Benifors Favira and Rousseau's rear. A similar approach has been previously validated and published to evaluate other VAA regiments against HDD.
Speaker Change: In this model, the population estimate for the time to achieve HCBRNA less than the lower limit of quantification in the plasma was approximately 12 to 16 days.
Speaker Change: while the corresponding time to a fifth year was approximately seven to eight weeks.
Speaker Change: Therefore, this model provides further support for a high likelihood of success for the regimen deinevaluated in phase 3, with duration of 8 weeks in non-syrotic patients and 12 weeks in [inaudible]
Speaker Change: I will now turn the call over to Andrea to discuss Atea's financials.
Andrea Corcoran: Thank you, Arensam. As Jonae mentioned earlier today, we issued a press release continuing our financial results for the fourth quarter and full year 2024. The statement of operations and balance sheet can be found on slides 18 and 19.
Andrea Corcoran: The full year increase was primarily driven by higher 2024 external spend related to our COVID-19 phase three sunrise three trial as well as our phase two HCV trial.
Andrea Corcoran: for GNA, expenses in 2024 and 2023, were similar quarter-over-quarter and year-over-year.
Andrea Corcoran: Interest income, quarter-over-quarter, and year-over-year decreased due to lower investment balances.
Andrea Corcoran: In 2025, substantially all our external R&D spend will be related to the advancement of our phase 3 program.
Andrea Corcoran: As John Pierre mentioned, at year end 2024, our cash, cash equivalent, and marketable securities balance was $454.7 million.
Moving to slide 20
Andrea Corcoran: As noted in our press release today, we announced a reduction of our workforce by approximately 20-25%
Andrea Corcoran: in early January . This action is intended to enhance efficiency in the management of infrastructure expenditures and is expected to re-out in a cost savings of approximately $15 million through 2027.
Andrea Corcoran: Additionally, we also announce that Arthur Kirsch has joined our Board of Directors. His extensive financial and strategic advisory experience will further strengthen the Atea Board as we advance our strategic priorities.
Andrea Corcoran: We believe that Arthur's proven track record of executing and overseeing transactions will be invaluable as we pursue opportunities to enhance shareholder value.
Jean-Pierre: I'll now turn the call back over to jump here for closing remarks.
Jean-Pierre: Thank you, Andrea. In closing, we believe that our global phase 3 HCB program is the risk with a high compelling value proposition.
This is based on substantial clinical and mostly clinical data.
A well-characterized regulatory pathway, optimized manufacturing processes.
Jean-Pierre: a durable multi-billion dollar market and a long pattern right away.
Jean-Pierre: We believe that the regiment of Benny Farsman and Rosa Zvia, which is potential best-in-class profile for the treatment of FITIEC, if approved, provide an opportunity to become the most prescribed treatment.
Jean-Pierre: and disrupt the global epidemiology market for approximately $3 billion in annual net sales.
Jean-Pierre: Before opening the call to your questions, I would like to thank our talented and dedicated at Ate employees.
Jean-Pierre: I would team a relentless pursuit of excellence, drive our dedication to advancing all antiviral therapeutics for patients worldwide affected by severe viral diseases. With that, I would turn the callback over to the operator.
Jean-Pierre: Thank you. To ask a question at this time, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment while we compile our Q&A roster.
And our first question comes from the mind of Bella.
Cammunch with JP Morgan, your line is open, please go ahead.
Jean-Pierre: Hi, this is Bella on for Eric, just two questions from us here. First, following your meeting with the FDA, are there any specific callouts that they've guided for in the Phase 3 trial design? And then second, what can we expect in terms of the scope of your face to read out later this half?
Speaker Change: Janet, you want to address the first one and then I will answer with a draw to the second questions.
John . Thank you very much.
Janet Hammond: So, with regards to our meeting with the FDA, no, I don't think really any distance would call out. They are fully aligned with our approach of going forward with two open labels as three trials.
Janet Hammond: I think it's somewhat unconventional to run open-dabel trials, but I think given the circumstances.
Janet Hammond: of the different properties of the drugs in the population that we're studying. This is completely in agreement with them and they didn't ready, have any substantive comments around the conduct of the trial?
A ransom?
Speaker Change: Yes, I think the question from Miller was about the space to read out, so we're expecting to present data this summer at East Oles in May, and so you'll have additional data there in terms of the info from safety and all the other details from this topic.
of the Proto-Columbian family.
Great. Thank you.
Thank you, and one moment for our next question.
Speaker Change: Our next question comes from the line of Annie Shea with William Blair. Your line is open. Please go ahead.
Okay.
Speaker Change: Three questions from us if you don't mind. One is on the trial design for the Phase 3 program. I'm curious you have an estimated number of serotic patients across those two trials.
Speaker Change: Are they going to be strictly controlled, or this is kind of an estimation based on global and US epidemiology? So that's question number one.
Janet Hammond: That's your by one question at a time if you don't mind. So Janet, you don't do it. Oh yeah, that's right. So please.
Janet Hammond: So yeah, so they're estimates and we have targeted numbers of erotic patients that we'd...
like to see and roll in the trial. [inaudible]
Janet Hammond: But the number of serotic patients, I think, generally worldwide, has declined with the advent of direct-acting anti-rural therapies. I think particularly, sir, in the US that I'm harder to find than I think they were when the earlier direct-acting anti-rural trials were conducted.
Janet Hammond: But we do anticipate seeing somewhere in the order of just north of 10% probably in our trial, and that's also aiming for.
Speaker Change: I see is there an ability for for you to adjust that number if you're seeing maybe a little bit lower or a little higher as the trial is enrolled.
Speaker Change: So we do have some flexibility in there and obviously if we can achieve more and get greater experience, I think that will be important but I don't think there are an absolute requirement around that we want to have sufficient patience.
Speaker Change: and Rosa's to be able to justify having that population in our label, but I think we're certainly going to do the best we can to have enough, but there is flexibility now.
Speaker Change: That's helpful. Second question has to do with the modeling, which is very unique on flight 16. So I'm curious if you were to plot this.
Speaker Change: with Epp Kusa. Would you expect those two lines to be right shifted for Epp Kusa across [inaudible]
Speaker Change: This model has been developed by Dr. Alan Pelsen from Los Alamos and please share Eric, there is publications with direct anti-vow for H7.
Okay, okay.
Speaker Change: Okay, that's helpful. Okay, that's actually so sorry for the confusion. There's just two questions from us, but thanks for your input.
You're very welcome. Thank you for the questions.
Speaker Change: Thank you and again ladies and gentlemen. If you would like to ask a question, please press star 1-1 on your telephone.
Speaker Change: I'm showing no further questions and I would like to hand the conference back over to John P.R. for closing remarks.
Jean-Pierre: Thank you for all of you for joining our 4th quarter, 2024 earning conference call and thank you for your continued support.
Jean-Pierre: This concludes today's conference call. Thank you for participating and you may all disconnect. Everyone have a great day.
Thank you.