Q2 2023 Atea Pharmaceuticals Inc Earnings Call
Yeah.
Good afternoon, ladies and gentlemen, welcome to the a T. S Pharmaceuticals second 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 the call up for your questions I would now like to turn the call over to Jenny Barnes Senior Vice President of Investor Relations and corporate communications at a D O Pharmaceuticals Barnes. Please proceed.
Thank you operator, good afternoon, everyone and welcome to the Teva Pharmaceuticals second quarter 2023 financial results and business update conference call earlier today, we issued a press release, which outlines the topics. We plan to just Scott 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 Dot I pay a farm of Dot com.
With me from a payer are our chief Executive Officer, and founder Dr. John P. R C.
Case development officer, Dr. Janet Hammond Doctor Rancher, Hawker Chief Medical Officer, Chief Financial Officer, and Executive Vice President of legal and dry up Corcoran and our Chief commercial officer, John beverage that they will all be available for the Q&A portion of today's call.
We began the call 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 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.
I'll now turn the call over to John here.
Thank you John Good afternoon, everyone and thank you for joining us.
I will begin on slide eight during the first half of the year.
We have made considerable progress across several probably 19 in HCV program.
Our COVID-19 program.
Fast track designation.
I've been at Fosterville was granted by the FDA in the second quarter and reflects the continuing.
You'll need that rebates for COVID-19 patients.
Good day.
Including multiple data presentations during the first half of the year.
The favorable efficacy safety and lack of drug interaction profile a benefactor of it.
We believe that many parts of the B has the potential to address the key limitations.
COVID-19 therapies.
The protocol amendment modification that Janet.
Good day.
Phase III Sunrise trial.
We have adapted our protocol.
To reflect the current status of the pandemic.
While still remaining on track with our upcoming near term milestones, which include an interim analysis around the end of the year.
Top line results from this study anticipated mid 2024, we continue to target an NDA submission by year end 'twenty 'twenty four.
As part of a multi pronged approach against COVID-19.
We are advancing a discovery program focused on the second generation <unk> inhibitor that is highly differentiated.
And as our clinical profile quite unique and well suited for combination with <unk>.
We are continuing to make progress with this program and we expect to provide an update around the end of the year.
For our HCV program.
I am pleased to report that in June we began dosing patients in our phase II study evaluating the combination of any possibly beyond.
This was a significant milestone for us and we continue to expect initial results from the legend Cork approximately 60 patients around the end of the year.
Data presented earlier this year at the International Conference on antibody research support the profile of our HCV combination with in vitro data.
With a highly competitive profile compared to the current standard of care.
Importantly, we are well capitalized.
And in a strong position to execute on our mission.
Mission with more than $600 million of cash and cash equivalents and then Brad will go over the details with you.
I will now turn the call over to Janet for an update on our COVID-19 program.
Good afternoon, everyone.
The World Health organization current classification of COVID-19.
It just didn't establish pathogen of Kingstone.
And we believe that COVID-19 will remain an ongoing curious endemic issue.
Perfect 19, new take fostering new surrender changing more quickly and therefore better able to evade existing immunity from prior injections. It's also causes concerns about Bruce just keeping pace with the mirror taking bars.
Today, our recently identified kv tanking variant terrorists or <unk> 5.1 was reported to be the dominant circulating strain in the U S.
Interestingly it is keyed mutations that have been linked to the use of monoclonal antibody.
Highlighting how trades of ours is to continued mutation.
Teach debate, even newly generated monoclonal antibodies.
This underscores the important role for direct acting antivirals in the treatment of COVID-19.
Importantly, too niche.
Foster Creek is a high barrier to resistance due to its unique mechanism of action with the same person see against all very interested in.
We're confident that this will be consistently maintained as new variance continues to emerge.
Terrific 19 rates continues to fluctuate globally.
Japan has been experiencing its ninth twang.
And in the last couple of week Thursday, Europe U S and Europe, we're seeing an uptick in infections driven by the heatwave, which are sending people indoors to ask condition spaces like COVID-19 transmit small evil.
Turning to slide five.
Heading into the fall we are facing a situation of waning immunity with natural infection and the current vaccines.
As further exacerbated by alert with the uptake and the potential for mismatch between circulating strains and debatable boosters.
Furthermore, and some immuno compromised patients that we can say that mount any immune response to the vaccine.
The availability and use of oral antivirals is therefore going to be essential.
Particularly for the elderly and immunocompromised and those with underlying risk factor to prevent infection.
Unfortunately, there is still an unmet need with the currently approved antivirals.
Safety concerns and drug drug interactions with commonly prescribed medications, which didn't Douglas.
We believe that the compelling personal I'll, let them talk to that is differentiated because of its low risk of drug drug interactions and the absence of Michigan, the cookie and embryo fetal toxicity preclinical study.
I'll go for COVID-19 is to deliver a safe and effective treatment for the millions of patients, especially in the current standard of care is not official option.
Moving to slide six.
Taking into account the current COVID-19 environment for Sunrise tree.
We are adapting the eligibility criteria for the high risk patient population.
We are also increasing the sample size to recognize the current lower rates of hospitalization and death.
The modifications to our studies are designed to increase the probability of success in bringing the promising medicines to patients who need it the most.
We have expanded the global footprint, just a nice story and we are now targeting approximately 330 clinical trial sites in 30 countries.
With twisted waves, appearing sporadically and somewhat unpredictable vehicles the world.
Our goal is to position ourselves to be ready to capture these waves as they arrive in different geographies and at different times.
First of all amendments is being reviewed by the FDA and we have started to implement these modifications.
Importantly, this amendment should not change the timing guidance for the program and we continue to anticipate top line results midyear 2024.
And we are targeting a new drug application submission by year end 'twenty 'twenty four.
Slide seven shows a bit more detail on the latest protocol amendment modifications.
On the total patient population, we have made a number of modifications to the high risk and its ability questionnaire.
High risk patients are now classified as being at least 70 years old which is down from the eight T.
Being at least 55 years old with a risk factor.
Down from 65 with a risk factor.
Being a key 50 years old with two or more risk factors and your question.
And being at least 18 years old and immuno compromised which is unchanged.
Additionally, we've expanded the study to include patients with decreased renal function.
We have addressed the lower rates of hospitalization and death by increasing the sample size to approximately 2200 patients.
This approach is monotherapy arm.
And this is statistically powered to detect a clinically meaningful reduction in hospitalization or death placebos.
Hospitalization rate to 3% in this patient population.
Lastly, there will now be two interim analyses the D. S M B to review in the supposed can monotherapy.
Approximately 650 and 1350 patients with.
With initial top line data anticipated mid next year.
These notes with the D. F N B review, we do not expect to report efficacy results. As these analyses are primarily geared towards safety and futility.
Turning to slide eight.
We are seeing strong operational execution, so far nice stream from our clinical team.
And we now have regulatory approvals and approximately two thirds of the targeted country.
Patient enrollment continues and we believe we are well positioned to enroll patients with new variants in waves of COVID-19 infection continues to nudge.
In summary on line three is focusing on the high risk patients and its primary endpoint of all cause hospitalization or death.
<unk> 29, and approximately 2200 patients in the supportive care monotherapy arm.
I will now hand, the colter gunshot to review our HCV program a renter.
Thank you Janet.
Moving to slide 10, let's now discuss our hepatitis C program, a combination of many phosphorate angles because.
We believe that this combination has the potential to improve upon the current standard of care by offering a protease inhibitor free shorter duration options for hepatitis C patients with and without cirrhosis.
In June we achieved a major milestone for this program one with the first patient dose in our phase two trial.
There still remains an unmet need for hepatitis C patients.
According to the World Health organization.
People go.
Valley have chronic hepatitis C infection and there are approximately one 5 million new infection by the card per year.
Annually, we lose nearly 300000 people to hepatitis C related liver diseases and more people continue to be infected unclear. Despite the availability of DAA treatment options.
The CDC estimates that around 2 million people in the U S are infected with hepatitis C. A new infections are almost four times as high.
They were nearly a decade ago.
In addition, the reinfection rate can be in the range of 20% and people who inject drugs. We believe that there is a substantial opportunity to improve upon the current standard of care.
As detailed on slide 11, the combination of any first of all the angles of theories very potent it has the potential to be a best in class regimen based on expand genotypic antiviral potency low risk for drug drug interactions absence of food effects and the potential for a shock treatment duration will talk.
With cell therapy, and we may explore shorter durations subsequently.
This profile along with the totality of the preclinical data gives us confidence in the potential for this combination to become the new standard of care.
Recent data presented on our last earnings call, which can be found on our website showed that in vitro have any false will be released at least 10 times more potent than sofosbuvir against all genotype <unk> and genotype three AE and Friday resistance associated variants or Rob.
Well. This is there is a potent MFA integrator in our Replicon assay was supposed to be.
Your husband wants to trade at a more favorable in vitro.
As compared to <unk>.
Similar anti viral activity to prevent that.
<unk> is the most potent Dennis.
Currently.
In fact in the same.
<unk> Replicon assay, Bruce <unk> was shown to be five to 10 fold more potent than <unk> against all drops.
These data can be found on our website.
Slide 12.
Outlines our phase II open label study of any phosphate Andrew Sofia in hepatitis C patients.
This is study is expected to enroll approximately 280 hepatitis C infected antiviral knife patients across all genotypes, including leading cohort of approximately 60 patients.
<unk> will be administered by 150 milligrams have been thoughtful in combination with 180 milligrams. So we're supposed to be a once daily for eight weeks.
The primary endpoint of this study.
Safety and sustained virological response or SVR at week 12 post treatment other biological endpoints include virological failure.
A week 24 post treatment resistant.
Dosing patients in this clinical trial is ongoing with initial data from the leading cohort of approximately 60 patient anticipated around the end of this year.
And with that I will now turn the call over to our CFO Andrea <unk> to summarize our past financial question.
Thank you Lorenzo.
Mr. Nate mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the second quarter of 2023.
Shipment of operations and balance sheet are on slides 14 and 15.
For the second quarter 2023, each of R&D and G&A expenses remained relatively consistent with the second quarter of 2022.
As we further our clinical development of both our COVID-19, and HCP clinical programs in 2023, we do anticipate that R&D expenses will increase in a measured way as these programs advance we are exercising focus financial discipline to manage spend as we invest in these programs.
At the end of the second quarter of 2023, our cash cash equivalence and marketable securities balance was $608 1 million.
Based on these.
Curt plans, we are reiterating our cash guidance with a runway well into 2026.
I'll now turn the call back over to Sean <unk> for closing remarks.
Thank you Andrea and conclusion.
We have already made considerable clinical and operational progress across our COVID-19, and HCV program. So far this year.
We have also population presented a significant scientific and clinical evidence.
Support of the potential of our clinical programs among an audience of leading virologist.
Specialist at several scientific conferences this year.
With a number of interim analysis of data Readouts coming over the next year, we will continue to highlight the potential of our program and execute on our mission to improve the treatment landscape for severe diseases.
We thank you for your continued interest.
Support.
Yes.
As together, we strive to integrate the unmet medical needs of patients with serious violent interactions with that operator.
We will now open the call up to your questions.
Thank you and as a reminder, ladies and gentlemen to ask a question simply press the star key and one on one.
One moment, while we compile the Q&A roster.
Once again that is star one one to get in the queue and ask your question.
One moment for our first question.
Come from Maxwell Clark with Morgan Stanley . Please proceed.
Hi team. Thank you very much for taking my question could you expand a bit on the expected COVID-19 infection rate driving your interim analysis guidance.
Specifically, how is enrollment going so far and does your guidance expect a.
Wave in the fall thank you very much.
Janet I want to address that question. Please.
Sure.
Enrollment enrollment I think is in line with the current range of infections at the moment.
We're very pleased with the progress that we're making in executing on our geographical footprint. So we are well positioned to take advantage of such as as they occur and we do expect that there will likely be.
As we move into the winter months.
The infection rates.
It's going to be watching Skype debates ready the hospitalization rate, which is almost paramount importance to us because that's the primary endpoint of risky for the trial.
I hope that answered your question. Thank you.
Yes. Thank you.
Thank you one moment for our next question.
Alrighty comes from the line of Omar Ralph Clark or during Choi with Evercore.
Yeah.
Hi, This is Jessica on for Martin and John just two questions for me.
So first question is by lowering the.
The age for Sunrise trial.
Does that mean, incorporating younger slightly younger patients means healthier patients and like how would that affect the placebo arm performance and then secondly.
Previously the previously communicated interim analysis in the second half of the year, presumably would've given us efficacy data and now youre, saying that interim analysis is moved to year end Flash 124.
And no efficacy data will be provided so are we only getting efficacy data for the first time.
Mid 2020 for now thank you.
Okay before Janet.
Well further argue a quick question.
Always gave a guidance for the end of the year and we always indicated that it was not leading to any efficacy data analysis with the SMB, we always indicated the guidebooks.
Got it.
You bet.
Safety of utility.
Long ago, the DSM be indicating that we continue the trial. It was a positive step. So we have not changed any guidance relates to release that data.
Regarding the SMB outcome, Janet can you address that please.
Thank you yes.
In regards to hearing AIDS.
I don't think that in this instance younger.
Yeah, what we have been experiencing is that we've actually had to exclude patients on the basis of the fact that there were two young but actually we're well qualified patients and potentially we're going to end up in hospital.
Untreated and so work with what we think is that we have actually probably enhance our ability to enroll the study effectively.
Allowing in younger patients the younger patients.
<unk> highlighted with risk factors and depending on the age the number of risks practices is also contingent.
Contingent on that people 50 isn't about with two risk factors for progression and people 55 and above with at least one risk factor for progression and I think when you look back on the data presented by other advisory councils and so forth I think you will see that this is actually a good patient population.
<unk> risk for hospitalization and of course, it's placebo controlled as you mentioned answer.
Perfect.
Equally we're pretty confident that this or not too.
For such enroll more patients for less hospitalizations that actually allow us to do the study and and then allow patients in who should actually be eligible for enrollment.
And just to.
To emphasize you can check.
Sure.
First quarter on the release, so I will.
Sure.
Annual shareholder meeting.
Interim analysis or the expected Q4, 'twenty three so Q4 as part of end of the year.
We ran basically a little bit more detail to you but.
We have not changed any of our guidance.
Okay.
Okay.
Does that answer the question.
Yes.
Thank you very much.
One moment please for our next question.
Okay.
Yes.
Okay comes from the line of Tim Lugo with William Blair.
Hi, Jim This is John on for Tim. Thanks, So much for taking our question maybe.
Maybe just two for Matt.
First for the HBV program can you remind us what data you are planning to release with a leader in cohort this year.
What should we be looking for in those data.
Are you planning on making any adjustments to the protocol following those results.
And secondly, can you remind us of the Korean HBV resistance associated variants landscape and how inquiries.
The Pan genotypic activity of your combo versus short duration or other aspects of the profile.
Sure.
Alright.
You'd like to.
Address the first question. Please and then I will take the second one.
Yes.
Recall.
The leading cohort, we're looking at safety Tolerability and efficacy as well.
And that we are expecting to have that ready by around the year end.
So.
We began the resistance actually.
We are.
We're working to try to quantify.
And we're just a resistance up to 16 to 18 passages with Ben you still have a very difficult time.
To find anything that.
Key mutation signature for Benny positively on HCV.
Thats.
Further demonstrating our high bio resistant of this drug against HCV and I should say in the same way with all the new viruses.
But with that said.
And this is in our website, you will see that as compared to a sofosbuvir.
So those things.
<unk> potency.
Yes.
Basically there was a knockout.
So the EC 90 remain exactly the same though.
20 now in the mall.
On to the mall, which is 10% to 50 cars.
More potent than <unk>.
So Bobby also positive year, regardless of BRAF and including the 282 mutation which is.
D.
The key signature for Sop.
Positive yes.
I think by the end of the year, we will have.
Probably a a V.
Decline molecular mechanism.
It's a multi pronged.
As we have shown with.
Against the coronavirus.
We have some very interesting data.
I confirm that.
Are there any positive he is targeting several key.
Molecular site not just change the emulation.
<unk>, but also on the.
The molecular side that the critical core HCV replication.
Sure, we definitely would share with the street by the end of the year.
And we are very pleased with <unk>.
When we compare the feature that against your press release.
And and we know that.
The breadth of the <unk>.
Excellent and then as far as day.
It is combined with a quota.
We all know the issues with <unk> inhibitors in terms of drug drug interaction for the resistance and others. So that's why we feel very strongly that.
We have a potential.
Best in class.
Regimen and theirs.
RASK has indicated.
We feel very confident that the eight weeks.
Sure.
Be very effective.
And then Africa.
Okay that makes sense for me I think I mentioned in previous call that.
Alan solidly.
In person.
With the really the leading extra bulk kinetics is going to work with us and to determine if we can go even to shorter duration that eight weeks, which would be obviously.
Very transformational for it makes UV Campbell.
Thanks, so much.
Good luck to you.
One moment for our next question and as a reminder, if you do have a question just press star one one and it comes from Roanna Ruiz with Leerink partners. Please proceed.
Hi, everybody. Good afternoon. This is Matt gastric on for <unk>. Thanks for taking our questions maybe first on your Covid.
19 program I guess, given the evolving landscape.
What's the new bar for efficacy in the upcoming phase III trial.
Sort of reduction in hospitalizations and deaths would you consider clinically meaningful.
And then I have a quick follow up about the enrollment criteria.
Jonathan you want to.
Your question please.
Yes, I think I think I mean, it's an inch.
Just a question I think it needs to be kind of Q4 and I think it's obviously also determined to some extent study.
Variance of the circulation Burton.
And I think that has changed over time I think just to remind you.
The treatment.
Response rate of protection against hospitalization with tax Levered during the omnicom.
They are in time with between 58, and 78% and we anticipate efficacy to be competitive with what they have been able to share.
Very helpful.
Also noticed that you mentioned.
<unk>.
Allowing enrollment of patients with decrease renal function now I'm.
I'm curious what degree of renal impairment.
Are you, allowing do you anticipate needing to modify the dose of Thunder Foster here in these patients.
Janet.
So we're in the process of working through.
Renal study, which is part of the normal NDA package and we have now.
<unk> patients.
The pharmacokinetics.
Patients with creatinine clearance was down to <unk>.
So patients who have those types of.
Levels of renal dysfunction eligible now to be enrolled in our trial.
And.
Looking at other nucleoside analogs that have been used for the treatment of Covid.
Thank you if I can sneak to modify the dose.
But we're in the process.
Understanding that as we work our way through and patients with further levels of renal decompensation.
Got it thanks, Janet one more if I may.
I'm talking about your longer term plans for <unk>.
What's your outlook on possible partnerships and COVID-19, both in the U S or maybe outside of the U S.
Okay.
John do you want to take it.
I would add a little twist.
But go ahead John .
Sure. So I think tore we still remain consistent and what we have been projecting and that is for ex U S.
Markets will be looking for.
Hartner shifts and for the U S market, we will likely be looking to co promote.
What's an appropriate partner and those activities continue.
J P.
Yes, basically look.
As you know.
So far.
Every market is the 90% in the U S.
We are.
We have a strong balance sheet.
And really the rationale why.
We go well into 2026 and not broader than that.
We already accounted for a robust launch ourselves.
If needed.
So.
We are obviously.
Jr indicated.
Sure Paul.
Our balance sheet.
We are going to span.
With our programs in the same time, we have the muscle.
In the U S. Obviously as John indicated not outside the U S, but especially in the U S. We're still at 90% with $8 billion.
We have the muscle to go out with a very robust launch.
And Thats why basically youll see our runway.
All of these retails and not.
Longer than that to $600 million.
Helpful. Thank you.
Thank you and I don't see any questions in the queue I will turn the call back to John <unk> for his final comments.
Thank you again for.