Q3 2023 Atea Pharmaceuticals Inc Earnings Call
Yeah.
Okay.
Good afternoon, ladies and gentlemen, welcome to the Acadia Pharmaceuticals third quarter 2023 financial results and business update conference call. At this time, all participants are in a listen only mode.
The formal remarks, we will open the call up for your questions.
I would now like to turn the call over to Janet Barth Senior Vice President of Investor Relations and corporate communications at Teva Pharmaceuticals Mis launch. Please proceed.
Thank you operator, good afternoon, everyone and welcome to the Teva Pharmaceuticals third quarter 2023 financial results I guess next 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 will be reviewing today by going to the investors.
Section of our website at IR Dot a payer pharma dot com with me today from a tail are our chief Executive Officer, and founder Dr. John Cena jealousy, Chief Development Officer, Dr. Janet Hammond, Dr. Roger <unk>, Chief Medical Officer, Andrea Corcoran, Chief Financial Officer, and Executive Vice President.
And then up legal and our Chief commercial officer, John that breakout they will all be available 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 in the <unk>.
<unk> recent filings with the Securities and Exchange Commission, which we encourage you to read.
Actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to Sean here.
Thank you Jimmy and good afternoon, everyone and thank you for joining us.
Since the beginning of the year.
We made great progress across our COVID-19 in HCV program.
So as you can see on slide.
For our COVID-19 program.
All women Sunrise, our global Phase III.
Reflect the inflection rate occurring globally and the study a global footprint.
Courted by clinical data, including favorable efficacy safety and lack of drug interaction profile has been a positive here.
We are pleased with the progression of <unk>.
Sunrise suite study and we look forward to several important milestones in 2024.
Our goal for this program is to deliver an effective treatment to the millions of patients for whom the current standard of care is not adequate.
<unk> is here to stay.
Yes.
There was great vulnerability.
Urgent need for additional oral antivirals.
We believe that any thoughts with you as the potential to address the key limitations of current COVID-19 therapies, including safety and drug drug interactions.
New safe and well tolerated oral therapies are also needed to keep up with the evolution of the box.
The SaaS come to rise indeed is accumulating mutations with amino acid substitutions faster than any of the endemic I really rise.
To prevent the emergence of cross resistance, we needed a broader and more diversified arsenal of oral antivirals with various distinct mechanism of action.
As part of a multi pronged approach against COVID-19, we continue to also make progress with our discovery program focused on the second generation <unk> inhibitor that is highly differentiated and that's it was showed its clinical profile and we expect to share an update sometime early next year.
For our HCV program, we are very pleased with the substantial progress made in our phase II combination study of <unk> to prevent and reserves. We are quickly completed enrollment of 60 patients leading cohort and initial result.
I expected in early 2024.
Our goal for this program is to substantially enhance the current standard of care by offering an eight week Pan genotypic protease free treatment option for HCV patients.
Despite treatment options. Indeed, they remain a large underserved HCV patient population that continues to grow dramatically even in the United States due to the opioid crisis injection drug use and HCV infection.
For both our COVID-19 and HCV program.
Which are each multibillion dollar commercial opportunities.
We are well capitalized to achieve key inflection points with a cash runway well into 2026.
As of September 30th.
$595 1 million of cash and cash equivalents and no drag will go over the details with you.
I will now turn the call over to Janice.
Based on our COVID-19 program.
Good afternoon, everyone.
Jumping ahead gestation COVID-19 bearing to continuing to evolve at a very rapid pace.
On slide five you can see hall as quickly as every two weeks the variant proportions in the United States are changing.
Based on genomic sequencing results.
These rates are faster than reported for any other RNA virus.
And you can see why it isn't surprising that there are so many new varian circulating and it isn't possible to predict how these areas might suddenly result in terms of which mutations come next.
The associated with interactivity and ability to cost Z.
The CDC is currently monitoring Chelsea size, there of which HB one installations to be the dominant stream, but there are hundreds more that happened Jeffrey <unk> the level of community spread to appear on their radar.
Not showing up on the side yet.
Darren just omnicom th two six and it's an indication which is called Jan one which contains a further <unk> one additional unique mutations compared to HBV one five.
As you can see as a result of this record in a perpetual game of catch up with continued attempted updated vaccines that are often update before they become available.
Each new Barrington produces mutations that can impact vaccine efficacy and durability.
On top of the first generation monoclonal antibody has quickly become obsolete.
Authorizations reverse due to waning efficacy.
Alarmingly it is apparent that some recent circulation very seem.
Seem to have resulted from the use of monoclonal antibodies.
All of this underscores the important role for direct acting Antivirals, which are effective independent of mutations.
Potency 70, Fosterville has a high barrier to resistance due to its unique mechanism of action.
Maintaining potency against all variance tested to date and we anticipate that this will be the case as new variants continue too much.
Turning to slide six.
Supported by our extensive global footprint, we're seeing promising enrollment trends and also nice jury trial.
We have strong patient enrollment in the U S.
Clinical sites are being responsible for approximately 50% of the patients today.
The majority of patients globally continue to be enrolled in the monotherapy arm despite their awareness and availability of current oral antiviral options.
This clearly highlights the ongoing important unmet medical need which continues.
Safety concerns tolerability and potential drug drug interactions, which limit the use of the currently available agents.
Hitting into this winter.
Costs from the U S CDC.
Does this refer to Houston should be similarly high to last year.
Hospital with more full than at any other time points in the pandemic and worse than pre pandemic yet.
It's predicted that COVID-19 will likely account for approximately half of those hospitalizations with.
With flu and RSV combined accounting for the other half.
That's a very direct COVID-19 boost the uptake with Ridley vaccine is approximately 77% of U S. Adults, which leaves many susceptible to the virus without a suitable treatment option.
The most vulnerable to severe COVID-19 infection of the elderly the immuno compromised and there is the underlying risk factors for severe infection.
Turning to slide seven.
As a reminder, sunrise tree is focusing on high risk patients and its primary endpoint is all cause hospitalization or death.
<unk> 29, and approximately 2200 patients in the supportive care monotherapy arm.
There are two planned interim analyses for the SNB review at approximately 650 patients and again at 1350 patients in the supportive care monotherapy arm with initial top line data also anticipated next year.
Please note today's Smbs review, we do not expect to report efficacy results.
Analysis of prime to get towards safety and futility.
In April we were granted fast track designation for <unk>, which reflects the recognized unmet medical need.
Zane for COVID-19 patients.
We believe that the compelling profile of <unk> Foster Wheeler has differentiator that can the cane Creek unit, which are clear risks of drug interactions in total and it's good tolerability profile as well as the absence of mutagenesis T and embryo fetal toxicity in the preclinical study.
Our goal for COVID-19 is to deliver a safe tolerable and effective treatment for the millions of patients for whom this current standard of care is not a suitable option.
I am now going to hand, the call over to John to review the COVID-19 commercial opportunity.
Good afternoon, everyone on slide nine.
Let's discuss the COVID-19 landscape of active oral anti viral programs in clinical development in the U S under FDA review.
As you can see Sunrise III is the only phase III program in the U S.
<unk>, a new oral antiviral exclusively for the treatment of high risk patients.
Turning to slide 12, I'm, sorry, so turning to slide 10, the prescription demand for oral antivirals to treat COVID-19 correlates with the infection rates the demand for oral Antivirals in 2023 has been considerable and shows that the U S is averaging approximately 580000 scripts per month.
January through September.
Turning to slide 11.
As of November one the market for COVID-19, oral anti virals.
Can transitioning to the traditional payer markets, such as Medicare Medicaid and private commercial insurance.
Oral anti viral therapeutics for COVID-19 are expected to remain a mall.
All 5 billion dollar opportunity for years to come.
Projected annual COVID-19, oral anti viral use demand using IQ via retail prescriptions suggested estimated annual global market opportunity of approximately $10 billion.
To our knowledge. This is one of the become one of the largest anti viral markets.
Oncentration with only two products that have key limitations.
We believe there is still an unmet need with critical gas and there is an opportunity to expand this market to patients where <unk> tolerability and drug drug interactions as a concern.
In addition to the safety concerns with the Gabriel.
I'll now turn the call over to Roger to review, our Phase III <unk> HCV program.
Thank you John.
Moving now to slide 13, let's discuss our phase two hepatitis C program. Our novel combination of many Clos will be earned with Cynthia.
We recently achieved an important milestone and we completed enrollment of this 60 patient leading cohort in this cohort we are evaluating the combination of any fossil the angle of course safety Tolerability and sustained virological response or SVR at week four.
The primary endpoint of this study remains.
The week 12.
You May know there is an effective correlation between SCR a week for 12 and utilizing this correlation allows us to accelerate the study.
Patients will complete treatment this quarter.
I mean in the timeline for data analysis, we expect to announce initial results early 2024.
We are expanding the study geographical footprint to approximately 50 clinical sites in 15 countries and we plan to Reinitiate enrollment. After we review the results from the leading cohort we are receiving global regulatory approvals for the remainder of the trial and our brother investigation.
<unk> network, which help to lay the groundwork for the anticipated initiation of a global phase III trial, which is expected in the fourth quarter of 2024.
Slide 14.
Outlines our phase two open label study have been thoughtful leader on routes that are being <unk>.
Hepatitis C patients.
This study is expected to enroll a total of approximately 280, <unk> antiviral knife patients across all genotypes.
Including the leading cohort of 16 patients.
Patients administered <unk> hundred 50 milligram something thoughtful in combination with 180 <unk> once daily for eight weeks. The primary endpoint of this study is safety and sustained virological response or Disney at week 12 post treatment.
Although virological with endpoints include virological failure and vital resistance.
We believe that the combination of many first <unk> has the potential to substantially improve upon the current standard of care by offering a broad they seem to be the free eight week duration option for hepatitis C patients with and without cirrhosis.
I would like to note before I handle over the call to Andrea.
We will be presenting two posters at the 2023 annual meeting of the American Association for the study of liver diseases. Later this week.
Includes supporting data for Benny first Fabio who says we're highlighting the potential to use these two drug candidates together as a novel treatment for hepatitis C.
And with that I will now turn the call over to Andrea to summarize at their financial position.
Thank you Lorenzo.
<unk> mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the third quarter of 2023.
The statement of operations and balance sheet are on slides 16 and 17.
For the third quarter 2023.
G&A expenses remained relatively consistent with the third quarter of 2022, there was an increase in R&D year over year.
Third quarter related to the advancement of our COVID-19 in HBV clinical programs.
Do you anticipate that R&D expenses will continue to increase in a measured way as these programs continue to advance.
We are exercising focused financial discipline to manage spend as we invest in both of these programs.
At the end of the third quarter of 2023, our cash cash equivalent and marketable securities balance was $595 $1 million.
Based on our current plan, 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.
So in closing we have made great clinical and operational progress across so with COVID-19.
Hey, Savi program, so far this year.
We have also published and presented significant scientific and clinical evidence in support of the potential of our clinical programs and longer now Joseph leading virologist and infectious disease specialists.
Several scientific conferences this year.
We will continue to highlight the potential of pilot programs.
<unk> scientific conferences, including the <unk> later, this week and through the publication of our data.
We know the clinical data is very important.
A number of interim analysis and data Readouts starting in early 2024, we believe that next year would be transformational for test.
As always we thank you for your continued interest and support.
Together, we strive to address the unmet medical needs of patients with serious diseases with that operator, we will now open the call up to your questions.
Thank you Sir.
Just to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Please standby, while we compile the Q&A roster.
Okay.
Our first question comes from the line of Eric Joseph with Jpmorgan. Your line is now open.
Good evening, Thanks for taking my questions I guess, just having pushed out the timeline for the first interim analysis here a little bit for Sunrise III can you talk about the.
The pace of enrollment in the study.
Ultimately your level of confidence in being able to fully control the fully enroll the trial.
Should the interim analysis support.
I guess with respect to the interim analysis itself other than for fertility rolling that out.
How does the interim sort of de risk the the studies have been in that space.
Can you speak to that a little bit.
So.
Related to the time lives I would like to remind you that on our last earning call for Sunrise.
We said the first interim analysis will be around year end 'twenty.
Q1, 24, and we adjust planning for Q1 24, So I don't think Thats changed any timeline and we are on track with this timeline related to the detail for the interim analysis.
The DSM V will do in <unk>.
Our projection Janet can you address the rest of the question. Please.
Sure.
First of all thanks for the questions Eric with regard to the pace of enrollment I think the pace of enrollment is very commensurate.
Warfarin as being worldwide in terms of such as it was I think a perception.
I think a great effort by everybody really that towards the beginning of some of that.
Because it might actually have lasted getting away and then I think we all experienced the fact that there was a huge surge at the end of July into August early September I think somewhat subsided now, but we are starting to hear reports of the next such.
Really starting up in Europe, and we anticipate that there will be.
Considerable surge as we head into the holiday season. Unfortunately, Sir.
Have a very.
Broad geographical footprint for this trial and so we have.
As we've mentioned I think previously we have densification of having in excess of 300 Psi.
The work available to enroll patients as these searches occur and so we're pretty confident that we can I'm, assuming all else goes well as you mentioned with regard to the SMB.
The trial.
And <unk>.
Fortunately it does it does seem that <unk> just going to follow another I think with regard to walk the F&B can answer for us in regards to things other than facility I think it's primarily going to be around the safety profile being acceptable for us to continue to enroll patients and if we're not doing anybody any harm by.
Continuing to keep the trial open from that perspective, but with regard to say with regard to efficacy or we wouldn't have any readout from them in that regard, yes, thats safe to proceed.
Okay.
Helpful.
I guess could you suddenly frame the second data room as well in terms of what.
What that might inform from an efficacy.
So it gives you a perspective.
The first of them.
So I think this first interim.
Interim analyses are really designed primarily towards ensuring that the study is able to achieve its primary endpoint of hospitalization.
And that these hospitalizations of being distributors in a way where we.
We should be able to continue the trial and chief and readout at the end, but beyond that.
We will not have any efficacy information. So they will just just to allow us to proceed assuming it's not Tucson.
Okay, great. Thanks for taking my questions.
One moment for the next question.
Your next question comes from the line of Maxim <unk> with Morgan Stanley. Your line is now open.
Great. Thank you.
I'm, just what I'm trying to summarize three in the context, giving low given lower hospitalization rates and the competitive landscape, specifically gilead announced that their oral phase III trial is fully enrolled with approximately 1900 participants at standard risk I think their data is expected in early 'twenty. Four so have you thought about revisiting standard risk.
Patients with a primary endpoint other than viral load to accelerate development. Thank you.
Dennis you want to address the questions and thank you yes.
Yes.
Yes.
Yes. Thank you. Thank you for the question and yes of course, we have considered that but we actually do believe that hospitalization is probably the most important.
Benefits that can be achieved from using the direction and style.
I think there are some important differences between our trial and then Youll recall Gilead had two trials ongoing they had one which they terminated.
In high risk patients and then they have a standard risk patient populations are they looking for a reduction in symptoms.
And Ah Ah studies with more like the one <unk> terminated, but the second which they terminated.
Unlike us was not been working in the U S and as I mentioned in my remarks.
What is striking to us is that we are.
About 50% of the patients that we are enrolling in our trial are coming from the U S and I think.
That's partly due to the fact that I think throughout there have been substantial.
Perhaps more substantial education and availability of testing for patients and I think and awareness of Covid in hydrous vulnerable patient populations in the U S.
We continue to believe that all studies should be able to be enrolled in this patient population.
Perhaps because of some of the differentiation that we have we obviously.
Continuous continuing to watch and understand what others are able to observe and.
We'll continue to evaluate and assess what adjustments are needed to be made but at the moment. We believe that this is the patient population.
The need is the greatest and and also that because of our geographical footprint. It is something that we should be able to achieve.
Okay. Thank you.
One moment for the next question.
And your next question comes from the line of Jon Miller with Evercore. Your line is now open.
Hi, guys. Thanks for taking thanks for taking my question.
So I guess given that we're not going to get efficacy in the interim looks do.
Do you have any sense at this point when you do you anticipate having a good sense for efficacy when that could be communicated to us that a sunrise III.
Hi.
Based on that.
Right, but do you have any sense based on your expectations for curves and first.
Surges when that could happen.
Janet.
Thank you Tom for the question Janet.
Hey, John I think part of the answer is unfortunately no.
I think it's difficult he was part of it is that.
I think the the the such as Austin was unpredictable and the study is unique to remain language.
In order for us to be able to take it across the finish line.
Fair enough, maybe transitioning to that novel Pie that we'll get an update for in the first quarter do you expect to have a candidate at that time will there be preclinical data for us to talk about it I'm just trying to get a sense for what you might be communicating that update.
Well, John it would be for clinical data.
Okay.
And to be honest with you as the profile will be very different from NPI that has been approved or is in clinical development.
We like to keep a little bit.
A little bit more time before.
We will release this information because.
There's a lot of competitive intelligence.
We we.
Our concern that.
That will open a field that we believe we are going to be following Neil deal. So it's not going to be the standout.
He is a practical mechanical small molecule once or twice a day.
And.
Most of the old cross resistance.
Sorry.
Really a new generation and also has a very different.
All of that profile.
Thats.
We are working on.
Uh huh.
For competitive reasons.
Two to hold for now.
Sure.
We feel that.
We have a little bit more secure to field them.
And make a.
A little bit of labor I would say more progress.
And going to the preclinical development.
Alright, Thank you very much.
One moment for the next question.
And your next question comes from the line of <unk>.
With Leerink partners. Your line is now open.
Thanks, Operator, this is Rosa Chen on for honorees at Leerink partners.
A quick one on Covid and then a follow up on your HCV program.
So do you have a sense for how much your recent trial of magnets for Sunrise three has maybe impacted your enrollment.
Spanish or patient eligibility requirements.
Janet.
The rest of the question.
So the amendment.
Achieving regulatory approvals and we are seeing in the places where the regulatory approvals have been achieved thus we are certainty of rolling patients with a broader profile than initially.
I think we have yet to see the full benefit of it.
Takes a little while in some cases.
So the approvals to come all the way through I think we certainly benefited from the study.
We can see and also I think from the fact that we have as many sites to open as we do and so we're well positioned I think to take advantage of these are just now as they come through and lifting.
Lifting enrollment moving forward.
Quite well.
Thank you.
Thanks, so much and regarding HCV can you remind us what are the early adopters that you're hoping to target in the market and separately do you see your combination differentiate enough from what's currently available to be able to possibly take larger market share in the future if launched.
John do you want to address your questions.
Yes. Thank you for the question.
As you know.
Global net sales market for Hep C is quite large and in 2022 I think the net sales of approximately $3 $5 billion. So.
With the U S representing roughly 50% of that so there's definitely room for more than just two players but for.
Our profile that we believe we should be hopefully be able to achieve it is going to be pan genotypic protease free.
Protease inhibitor free and also to have no food effect.
And.
Being an AAV therapy, it should be able to compete quite well within that market for sure.
And obviously, how much share will depend on the final clinical profile that is demonstrated but we feel very confident that a market of that size can easily accommodate <unk> III products.
That's helpful and if I could was a follow up do you have a sense for what the FDA is looking for in your phase III trial design. Because previously you mentioned the condo husky potential to be less than eight weeks of treatment, which would be quite a differentiating factor is that something you'll build into the phase III trials.
We're going to be able to see that.
Well look first we would never say that we are going to go to unless we say that we have the potential.
Possibly so we've done that even to this date Atlanta.
So, let's await that data.
We feel as John indicated I share with you that there is Matt.
I would say bluntly that closer for eight weeks, which is consider today the standard of care. When we know it's a very thin market because as John also indicated.
Compared to 10 years ago.
Uh huh.
<unk> would go right now.
New patients.
Clients as a major.
Actually.
It's a major issue.
Mostly IV drug abuse of opioids to the opioid crisis reinfection.
Sure the time.
As a highly differentiated especially eight weeks.
We'll see if we later on.
I'll answer the phase III.
Good.
Could you potentially six weeks, but definitely we anticipate.
For Phase III, we would go eight weeks as we said as a head to head against <unk>.
Believe consider.
And I agree.
Oh, the pathologist at 90 specialist theme.
I understand okay.
At this time.
Oh, we can.
Share with you any.
Oh, the interaction beyond the phase two with record.
The regulators and.
And when.
When we do we will we will show this year, but right now this is.
It's too early let's say to date on the phase two and then up to as we mentioned will go head to head and what are the face rate against our Coosa and then.
Let us discuss with the regulators.
How they see it.
This is <unk>.
The design phase.
Phase III study design.
Appreciate the color. Thanks, so much.
Yeah.
And your last question.
Will come from Tim Lugo with William Blair. Your line is now open.
Hi team. This is John on for Tim. Thanks, So much for taking my question.
Just wondering if you could remind us on what youll announce or Theyre in term DSM be analysis in the first quarter. So you just announced that the F&B either recommended continuing or stopping the study or will you provide some initial safety data as well.
Okay.
To ask a question.
I think we will just really announced that we can continue or not yes.
Okay, that's very helpful. Thanks.
And we have no further questions at this time I will now turn the call back over to Jon Petersen with Oc.
Thank you again for joining us today.
This is the end of <unk>.
Oh cool thank you.
This concludes today's conference call. Thank you for your participation you may now disconnect.
Okay.
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