Atea Pharmaceuticals Inc. Q1 2023 Earnings Call

Okay.

Good afternoon, ladies and gentlemen, welcome to the a T. A pharmaceuticals first quarter 2023 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 up the call for your questions.

I would now like to turn the call over to John Burns Senior Vice President of Investor Relations and corporate communications at a tier pharmaceuticals.

Please proceed.

Thank you operator, good afternoon, everyone and welcome to the Teva Pharmaceuticals first quarter 2023 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 web.

At IR Dot Italia pharma Dot Com with me today from Matteo, our Chief Executive Officer, and founder Dr. John P or somebody else see Chief Development Officer, Dr. Janet Hammond Chief Medical Officer, Dr. Roger Harker, Chief Financial Officer, and Executive Vice President of legal Andrea Corcoran, and our chief commercial.

Mr. John Backbreaker, they will all be available both for the Q&A portion of today's call 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 risks and uncertainties. These risks and uncertainties are outlined in today's press release and then the company's recent filings with the securities and <unk>.

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 John here.

Thank you Joe and good afternoon, everyone and thank you for joining us.

As you'll see on slide <unk>, we have had a busy start to the year with progress across so probably 19 in HCV program.

I will begin with a few highlights from our COVID-19 program first.

Laser focused on the execution on our global Sunrise III study.

Well I am pleased to report that as of today, we have a broad geographic footprint with regulatory approvals and over 50%.

Targeted countries.

Just last month, we were.

We're excited to receive from the U S. FDA fast track designation for many positive here for treatment of COVID-19, which has the potential to expedite that they've opened up any thoughts with you.

We presented multiple data sets at scientific meetings, including Coy I call. It like met each of which highlight if any possible clinical efficacy and favorable safety profile, including a compelling drug interaction profile finally.

We continue to make progress advancing our second generation protease inhibitor.

Turning to HCV, we remain on target for the first patient to be those who know a phase II combination trial this quarter.

And we continue to expect initial results from our first cohort of 60 patients.

Data recently presented the ichor support our combination profile and you in vitro results indicate a highly compelling antibody profile.

Pay up to the current standard of care.

Moving to slide four.

As I imagine.

The large presence there.

Major medical meetings during the first quarter some of the key highlights of our coffee program include the full results in the morning Sky trial were presented showing the 71% reduction in weeks ago first conversation, where there's been any thoughts would be as compared to placebo.

Morning, Sky trial was a subset showing 82% reduction in risk in patients over 40 years old.

Low risk of drug drug interaction with commonly prescribed medicine for Covid, 19, and HCV, which is.

He's a key feature of the drug.

Slide five.

The data presented at medical meetings beyond COVID-19 program.

I saw were presented HCV combination data showing up any possibility.

We are potent in vitro synergistic antitumor activity in in vivo preclinical safety without adversely in the right interactions.

We presented data.

2023 on the 87 five to put thank you.

Well as you know we did prioritize I would think of your program and the development of 80 752 in February 23, we are exploring opportunistic ways to continue to move these programs forward.

Moving now to slide six.

80, 511, the free base. So many positive yeah, that's been shown to be a potent inhibitor of Sars cov two in vitro results demonstrated 80 511 also as potent antiviral activity against the Sars Cov two of my phone surveying SBB.

This is consistent with the previously demonstrated in vitro potent antiviral activity against all the variance of concern and interest in clothing, Oh, sorry, beta gamma Epsilon downtime and values or my concern would be a one b to b a foreign be at five and now Dx.

I would now turn the call over to Jeremy.

Turning to slide eight.

Market dynamics continue to shift and the U S. COVID-19 public health emergency is set to expire this week.

Last Friday, the World Health organization, the chassis and to the global Health emergency.

They also went on to say the cabinet as a virus it's Jesse.

Okay, which is highlighted by the fact that globally nearly $2 8 million new cases, and as a 17000 deaths were reported in the last 28 days.

In fact demand there is still a large unmet medical need for the treatment of COVID-19.

We're experiencing waning immunity with both vaccines and natural infection exacerbated by the notice to uptake with only approximately 17% of the U S population having received a boost.

And in some patient populations. There is all sorts of any immune response to that.

Moreover, the limitations with currently available oral antivirals.

Considerable due to safety concerns and drug drug interactions with commonly prescribed medications such as seizure medications anti psychotics.

He coagulants and no.

This significantly limits the use of these drugs in high risk elderly and immunocompromised patients who are the most vulnerable and Ms. Jackie to help them do that.

Cases, just characterize.

As a result of this remaining unmet medical need and emergency use authorization is still available assessment criteria for insurance on that.

Turning to slide nine.

John P. I mentioned earlier, we are seeing strong operational execution from our clinical team.

The global Sunrise Street geographical footprint now has regulatory approvals in over 50% targeted countries and patient enrollment continues.

COVID-19 continues to evolve with new variants in waves.

What we are experiencing with the omicron SAP variant SBB 116 <unk>.

Sure sorry, where we've shown again good in vitro pregnancy with Ben you talked about.

Our goal is to enroll patients from circulation waves that being well positioned with our extensive global footprint as new varian and waves of infection much.

<unk> hundred three is focusing on high risk patients with arrest a greater risk of disease progression to severe COVID-19, amazing hospitalization and mortality.

Its primary endpoint is all cause hospitalization or death through day 29.

At least 1300 patients from the monotherapy cohort.

I will now hand, the call back to jump here to review our HBV program.

Thank you Chad moving now to our hepatitis C program with a fixed dose combination of <unk>.

We believe that <unk> combination has the potential to improve upon the current standard of care.

Offsetting a protease inhibitor free shorter duration options for HCV patients with and without cirrhosis.

The positive here is a highly potent pan genotypic.

With demonstrated clinical antiviral activity.

In addition.

Yeah.

And then there's five inhibitor has shown growth genotypic in vitro and Steve all activity with EC <unk> lowered the turnpike tomorrow against all genotypes with demonstrated clinical antiviral activity.

Naturally occurring.

<unk> resistant variants.

Yes.

And can impact the effectiveness of currently available HCV treatment.

We recently profiled the antiviral activity of both spending and possibly beyond.

Against a panel of previous <unk> resistance associated variants selected in vitro or identify in HCV patients who fail treatment Luisa.

Yeah.

We are pleased to share. These data with you now supporting that we have the potential for best in class Regiment.

As outlined on slide 11.

Data show that many positive we have retained a high potency in vitro being at least 10 times more potent at all so positive against all HCV genotype one.

And genotype three.

And thus far you've a resistance associated variants or we call it grabs.

In addition.

As you will see on slide 12.

Vienna is also a portal and Thats 5 million EBITA.

In rapid assay.

<unk> has demonstrated a more fun.

Favorable in vitro profile as compared to past severe and similar.

See you all activity to prevent Serbia, which is the most potent and that's five and maybe took currently approved in fact.

And as outlined on slide 13 in the same trend.

Real quick on asset.

<unk> was shown to be five to 10 fold more potent than the past of you against drive HCV genotype one and.

And the difficult to treat genotype genotype Street.

Turning to slide 14.

In summary, the combination of <unk> with US here is very important and that's a potential it could be the best in class regimen based on expansion of <unk>.

Tivo potency.

Low risk for drug drug interaction.

So food effects and potential for a shorter treatment duration. Indeed, we are targeting eight weeks of therapy with the potential for even a shorter duration.

This profile along with the totality of the preclinical data gave us greater confidence in the potential of this combination to become the new standard of care.

As you will see on slide 15.

Normally diagnose HCV cases in the U S increased 400% between 2010 and.

2020.

And that's just mentioned this is an area, where we believe that many positive results via combination.

Can be especially effective given its potential for shorter treatment duration with a highly compelling profile.

According to the W.

58 million people globally.

Chronic HCV infection and.

Approximately $1 5 million new infections, appearing every year.

We lose nearly 300000 people to HCV related liver disease each year.

This has become such a problem even in the U S.

The U S. Government has recently proposed an HCV program with regard to eliminate age theory.

This is important.

You would recognize this resurgence and acknowledges the need for new effective treatment options.

On slide 16.

We outline our phase two open label study of any positive yet or is he makes CV patients.

The study will enroll approximately 200 and AEP HCV infected direct acting anti viral nave patients across all genotypes, including a leading CT approximately 60 patients.

Patients, who will be administered 550 milligram Denny Foster Wheeler in combination with <unk> hundred 80 milligram.

Once daily for eight weeks.

The primary endpoint of this study is safety.

Sustained virologic response, so as we are at week 12 post treatment.

All the virology endpoints include Virologic failure.

A week 24 post treatment and resistance.

Regulatory submissions for the initiation of this global trial.

Ongoing and dosing of patients in this clinical trial is expected to begin this quarter.

Initial data for the leading cause of approximately 60 patients is anticipated around the end of the year.

With that I will now turn the call over to our CFO .

Enjoy it broker to review our financial update.

Yes.

Thank you Pierre as Johnny mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the first quarter of 2023.

The statement of operations and balance sheet can be found on slides 18 and 19.

The first quarter of 2023, each of R&D and G&A expenses remain relatively consistent with the first quarter of 2022.

Further our clinical development of both our COVID-19, and HCP clinical programs in 2023, we do anticipate the R&D expenses will increase in a measured way as these programs advance <unk>.

We are exercising financial discipline to manage spend as we invest in these programs.

At the end of the first quarter of 2023, our cash cash equivalence and marketable security balance was $625 million.

Based on our current plans, we are reiterating our cash guidance with a runway into 2026.

I'll now turn the call back over to Jim here for closing remarks.

In conclusion, thank you Andrea and conclusion.

We have already made the notable clinical and operational progress across our recovering 19 in HCV program. So far this year.

We also presented significant scientific and clinical evidence in support of the potential of our clinical programs, how long an audience of leading virologist and infectious disease specialists at several scientific conferences.

We believe this data continues to validate our approach and will enhance our development efforts as we advance our global clinical trials.

We look forward to reporting our continued progress throughout the year.

We thank you for your continued interest and support of <unk>.

As together, we strive to address the unmet medical need for patients with viral infections.

Operator, we will now open the call up to your questions.

If you'd like to ask a question at this time. Please press star one one on your telephone.

And wait for your name to be announced.

To withdraw your question. Please press star one one again.

Please standby, while we compile the Q&A roster.

Our first question comes from Eric Joseph with Jpmorgan.

Hi, Billy on for Eric and we just had one question.

We recently hired from Pfizer about.

That.

Barron's borrowers doesn't need return event, just wondering what your thoughts are on that in terms of the competitive landscape.

Well.

We have not see.

Any data scientific conference.

Are we.

Everyone.

Got all the feedback.

Feedback from the unencumbered so it's clear that he looks quite interesting, but it's clear that we will need a lot more.

Data to address what either the potency and safety.

And what we expect with this new generation.

Thank you.

Our next question comes from Maxwell score with Morgan Stanley .

Hi, Thank you for taking my questions are.

Are you I just wanted to ask are you on track to report interim analysis from.

From the Sunrise three study in the second half of 'twenty three and also I believe you stated on a prior call that you have not committed to reporting on the primary and secondary endpoints for this trial, but could you give any additional details regarding what we what we can expect after the in term. Thank you.

Sharon do you want to address the question.

Thank you.

So with regard to further west is on track.

I think the guidance has not changed.

Then with regard to the interim analysis, it will provide us the opportunity to re estimate.

And to increase our population is that he is deemed necessary in order to achieve the primary endpoint in the <unk>.

Highly endpoint is the all cause hospitalization and mortality.

In the patient population currently for statistical analysis, we are projecting that ultimate you will need 1300 patients in the standard cab monotherapy.

The remainder of patients of the 1500 would be incorporated into the combination.

With a current total estimate of 1500 patients.

But the primary endpoint is really just for the monotherapy patients and at the present time that is the anticipated population, we would need but that's what the interim analysis is designed to help us with Mitsubishi that week.

Upsize studies necessary depending on hospitalization.

Okay. Thank you.

Yeah.

Okay.

Our next question comes from the line of Jon Miller with Evercore ISI.

Alright, thanks, so much for taking my questions guys.

Two quick ones from me.

<unk>.

The state of emergency is scheduled to labs, but you seem very confident that <unk> will still be available can you talk a little bit more about how are the regulatory environment, how you as it'll be.

Around if there isn't a state of emergency to support those and then secondly.

On that.

Interim data analysis from Sunrise.

The sizing of the primary endpoint, how will the high likely percentage of Sera positive.

Ah patients at baseline impact placebo rates of hospitalization. Obviously, we just saw this afternoon. Another company stumble on efficacy for their COVID-19 treatment, because placebo patients did better than expected due to the baseline serum positivity John I'm wondering where you are getting your estimate of baseline.

Baseline.

A placebo arm, a hospitalization rates and weather.

A higher numbers here positive patients at baseline might impacted estimates.

Jonathan maybe you want to start with the second question first.

And then we'll go to.

The first one.

Sure John .

Yeah. Thank you. It's an interesting question I think that.

We probably are is that obviously, we're getting too.

Have to see what the overall hospitalization rate is <unk>.

This is one of the points for the interim analysis is to determine.

What's the what's the hospitalization rate is and whether we need to upsize. The study in order to have a sufficient grace post utilization.

Finding that but just just understanding what that hospitalization wages and so that estimate.

Idea behind the adaptive design.

With regard to share of positivity.

It's an interesting, but I think a moving target in that.

We know that for the most part almost everybody has seen COVID-19 at this time and therefore, it's likely to be <unk> positive.

We believe that in the more vulnerable patient population.

Antibody.

Effective this publicly wanes over time more quickly than for others.

I think there's been some interesting articles actually in the last week or two again looking at the efficacy of the omicron booster and that sort of thing and again I think demonstrating that there is very rapid waning immunity to the vaccine as well as to natural infection and I think as the virus continues to evolve with new streams coming through its life.

You bought back in utilization is likely to continue but it's impossible, obviously to predict with any certainty what the hospitalization rate is likely to be as a result, and thats really the basis for why we have designed the study in that way I think firstly from the point of the population, which is the most vulnerable to hospitalization.

I think it's likely to be high.

In that patient population.

And then secondly, so that we can adapt study numbers if necessary to accommodate them.

Aloha hospitalization rates.

On the first question is we have always indicated we are targeting an NDA.

And if.

The EUA for data.

Will be sufficient.

So in the U S that would be wonderful, but let's not forget that.

We are targeting.

The NDA as we had indicated also that.

The.

FDA, indicating.

Indicating driving that this trial would be sufficient for.

A.

NDA filings.

Jonathan do you want to add.

Thanks.

No I think you've covered it well thank you.

Our next question comes from the line of Tim Lugo with William Blair.

Thanks for taking the question.

Maybe I'll switch the H.

J J P mentioned, the ability to reduce days of dosing for <unk> gear.

What kind of dosing regimen do you think you can achieve in the ongoing phase two are going to inform that.

Look that's a great question Tim.

Uh huh.

A better view.

Uh huh.

Yes.

Clinical data on the lithium court.

We have a collaboration with Ellen passed some as you know has to go on viral kinetics.

And Thats the analysis of those Biokinetics will really help us in determining.

So if we can go in term of.

The treatment duration.

Okay.

At the end of this phase two.

Yes, basically what we'll do is.

Ah well, obviously feel that we have a very good profile with eight weeks of protease Lee.

Understand okay.

Okay.

Great safety, especially you can see the difference.

When we are talking now.

And there's five a variance.

The field is also the only thing that communication is very different now.

Now the six or seven years ago Windows in this five year variance actually will not as extensive as deal today and we believe that this is going to play a major role in the differentiation of our combination.

A lot more potent against any of those.

Variance as.

As compared to a closer.

For example, so.

No.

And we will see as soon as we have the volte genetics.

Even.

So, though we can go down to eight weeks.

Thank you so much.

As a reminder to ask a question that is star one one.

Our next question comes from Rwanda Ruiz with SBB Securities.

Hi, This is Rosa Chen on for Amit a couple from us on that path.

Airport.

So congrats on getting fast track designation for that would be from Barrick first we understand its implications for a potential NDA, but Joseph fast track designation provide advantages for potential EUA submission.

Secondly, what proportion of the monotherapy population and Sunrise three do you expect will be coming from the U S.

Is that representative.

The fall enrollment so interim and Paul Thank you.

Janet.

Yeah, I think Scott.

Fast track designation from ultra allow us to have a close and collaborative.

Today's rates change and discussion with FDA as we proceed with the clinical trial.

Submissions.

I think there's the possibility that this will allow us to go.

More rapidly than otherwise and secondly, I think obviously similarity with the data might help.

FDA termination of.

Whether the data are all worthy of an.

An emergency use authorization, but thats, obviously sometime down the version and we'll have to see and it's obviously fda's discretion.

And then with regard to the proportion of patients receiving monotherapy.

In the U S and in comparison to elsewhere I think it's early days to comment on what that's going to look like but.

Secondly, I think the population that we're studying in our trial is a population that is particularly vulnerable to COVID-19.

I think for that reason interestingly offering in eligible for the currently available treatments within the U S and elsewhere.

We continue to see a good representation of.

Patients requiring monotherapy.

Both here and abroad.

Great. Thank you so much.

That concludes today's question and answer session I would like to turn the call back to John <unk> for closing remarks.

Thank you again for joining us today.

Yeah.

This concludes today's conference call. Thank you for participating you may now disconnect.

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Okay.