Q1 2022 Enanta Pharmaceuticals Inc Earnings Call

February 8, 2022

Okay.

And good afternoon, and welcome to the <unk> Pharmaceuticals fiscal first quarter 2022 financial results Conference call. At this time all participants are in a listen only mode. They will be a question and answer session at the end of the prepared remarks, please be.

This call is being recorded I would now like to turn the call over to Jennifer Viera Investor Relations. Please go ahead.

Thank you operator, and thanks to everyone for joining us. This afternoon. The news release with our fiscal first quarter 2022 financial results was issued this afternoon and is available on our website on the call today are Dr. Jay <unk>, President and Chief Executive Officer, Paul Mellett, our Chief financial.

Financial Officer, and other members of <unk> Senior management team.

We begin with our formal remarks, we want to remind you that we will be making forward looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and.

Our results to differ materially from those statements.

Description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC Anantha does not undertake any obligation to update any forward looking statements made during this call I would now like to turn the call over to Dr. Jay <unk>, President and CEO Jay.

Thank you Jennifer and good afternoon, everyone.

And then I had a very productive fiscal first quarter of 2022, as we made significant progress in our RSV and COVID-19 program.

Building, a strong foundation for important inflection point to come next year.

Today ill update you on our clinical development programs for respiratory syncytial virus.

Sars Cov, two and hepatitis B virus, all of which have the goal of providing safe and effective oral antiviral treatment for viral diseases impacting broad patient population.

Additionally, comment on our ongoing discovery efforts.

Progress in human Metapneumovirus.

And that that has a successful and proven history of discovering and developing antiviral treatment demonstrated by Catherine here. The HCV protease inhibitor component in Maverick, a leading treatment for chronic hepatitis C virus.

Have expanded and leveraged this long and deep experience in virology.

<unk> small molecule therapeutics for multiple viruses recently, expanding our respiratory virology pipeline by developing a corona virus protease inhibitor for Sars Cov, two and then Ellen inhibitor for RSV.

The pandemic has made it clear that viruses can cause serious disease, which makes our work, especially significant.

With that backdrop today I'll start by detailing progress in our respiratory virology program, where we continue to build an industry leading treatment portfolio.

Advanced RSV program as our in protein inhibitor, Edp 938, which has fast track designation and is currently in three phase III studies in multiple patient populations.

Surely we continue our leadership in RSV with the announcement of a clinical candidate in our <unk>.

RSV L inhibitor program Edp 323.

As a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality.

The virus can cause serious disease in children.

ALDA really and the immune compromised and there are no treatments or vaccines available for the virus, which was first characterize and $19 56.

We are excited by the potential of Edp 938, which is a potent inhibitor of the RSV and protein that has shown robust clinical data in our phase Iia Challenge study, where it was not only safe and well tolerated, but also demonstrated significant effects on viral load and reduce symptoms of infection.

And this human challenge study of Edp 938, and we met the primary endpoint of viral load reduction and also a key secondary endpoint of total symptom score.

In order to confirm our findings outside of a challenge studies study we conducted the RSVP study to evaluate Edp nine created in an adult patient population infected with community acquired RSV and to provide us additional information on symptom alleviation and <unk>.

<unk> decline.

Following a period of decreased RSV transmission due to social distancing measures late last year. There was an uptick in RFP activity in various regions of the world, including parts of the United States, and Europe , which allowed us to complete enrollment beyond our initial target of 70 patients.

We are on track to report topline data from RSVP next quarter.

Our broad clinical development program includes two key phase III studies with Edp 938, evaluating safety and efficacy in young children and hematopoietic cell transplant recipients with RSV infection or.

Our clinical trial named RSVP, the phase III study in pediatric RSV patients in the trial RSVP Ed.

As to B study in adult hematopoietic cell transplant recipients with RSV.

Data from these two studies will confirm the doses to be used in subsequent pivotal studies in this population.

These studies, which were initiated after RSVP are expected to extend at least into 2023.

We are monitoring the RSP globally, and we will be providing further updates as the incidence rates of all.

This quarter, we are pleased to announce that we broadened our footprint in RSV you by introducing Edp <unk> three a potent RSV L inhibitor <unk>.

<unk> three targets the RSV L protein, which is a viral preliminaries that contains multiple enzyme activities required for RSV replication.

Preclinical data demonstrate an animal or potency across the major RSV subtype, RSV, a and RSV b and good absorption in plasma exposure across multiple different species.

We envision Edp three Q3 is a standalone treatment or for use in combination with other agents such as Edp 938 to potentially broaden the treatment window or expand the addressable RSV patient population.

We expect to initiate a phase one study of Edp 302, three in the second half of this year.

I am proud of the work we have done thus far in RSV and I'm excited by the potential of our broad development program, allowing us to extend our leadership in the development of treatments for respiratory viruses.

Turning to Sars Cov two we're also excited by the promise of Edp 305, our oral Corona virus.

<unk> protease inhibitor.

<unk> known as the main a protease inhibitor specifically designed for the treatment of COVID-19, Edp 235 is on track to begin dosing subjects in this month.

With first in human single and multiple ascending dose ranging study will determine the safety tolerability and pharmacokinetics of Edp three five in healthy participants.

In preclinical studies Edp 305 demonstrated highly potent antiviral activity against Sars Cov, two and pharmacokinetic properties supporting a once daily oral dosing regimen without the need for a boosting agent such as <unk>, all which indicate the potential of Edp 305.

Best in class compounds.

Specifically edp 305, potently blocks, the replication of Sars Cov, two and multiple cellular models, including primary human airway epithelium cells within <unk> 33 in animal or.

Importantly, Edp 305 has shown potent antiviral activity in vitro across a range of currently circulating Sars cov, two variance, including <unk> and Delta, giving at Penn Janet Pan Genotypic potential.

Furthermore, Edp 305 has potent activity against other human coronaviruses, enabling the potential for a pan Corona virus treatment, including possibly Corona viruses, the manpack human populations in the future.

Edp 305 is also shown excellent exposure after oral administration without ritonavir boost.

And favorable distribution into key target tissues, including lung and preclinical model. This.

This positions Edp 235, among the most potent direct acting Antivirals currently in development for Sars Cov, two infection with the potential for convenient once daily dosing.

With our phase one study is starting this month, assuming supportive data we would advance Edp 305 to the next stage of clinical development in the second half of 2022.

We also continue to pursue our respiratory virus discovery program in human Metapneumovirus or ATM PV of Iris that was first identified 20 years ago, and now circulate worldwide with nearly universal infection by age five.

Mike with RSV, either a number of vulnerable populations, including children, the elderly adults with underlying pulmonary disease and those who are immune compromised.

We are nearing completion of lead optimization of potent in animal or <unk> inhibitors, we plan to select a clinical candidate in the second half of this year.

Moving to hepatitis B, we remain committed to our vision of developing a combination regiments deliver a functional cure for chronic HBV patients.

Edp 501 for our HBV core inhibitor with SaaS track designation has been evaluated in two phase <unk> studies and different chronic HBV patient population.

Those who have a high viral load, whom we refer to as the <unk> patients.

And those who are on treatment with a nucleoside reverse transcriptase inhibitor, whom we referred to as nuc suppressed patients.

Last year, we presented data demonstrating that Edp 501 for his clear clinical evidence of a good safety profile alone and in combination with nuc and displays significant antiviral activity over 28 days with a pharmacokinetic profile consistently supportive of once daily dosing.

Orally, putting edp 514, among the best core inhibitors currently in development.

We remain focused on evaluating internal and external opportunities for additional compounds with alternative mechanisms to develop in combination with Edp 514, as we believe that the core inhibitors, such as Edp 501 for will ultimately be an important component of a successful combination regiment.

Before moving to the financials I would like to wrap up by reiterating our upcoming milestone.

We expect multiple catalysts, including the start of dosing in our phase one study of our oral <unk> protease inhibitor Edp three five this month.

Supported by Phase one results, we plan to advance Edp 305 to the next stage of clinical development for the treatment of Covid and the SEC.

Half of this year.

We plan to report top line data from the RSVP study of Edp 938 next quarter.

Finally, we look forward to initiating a phase one study for Edp 323, RSV L inhibitor and nominating a human Metapneumovirus clinical candidate in the second half of this year.

With that I'll stop here and turn the call over to Paul to discuss the financials Paul.

Thank you Jay.

I'd like to remind everyone that as manager reports on a September 30 fiscal year schedule today.

Today, we are reporting results for our first fiscal quarter ended December 31 2021.

For the quarter total revenue was $27 6 million and consisted entirely of royalty revenue earned on add these global HCV product sales of $427 million.

This compares to total revenue of $31 7 million for the same period in 2020.

As reported by Abbvie treated patient volumes remain suppressed compared to pre COVID-19 levels.

Royalty revenue was calculated on 50% of Maverick sales at a blended royalty rate for the quarter of 13%.

And on approximately 30% of the carrier sales at a royalty rate of 10% after adjustments for certain contractual discounts rebates and set offs, which are now approximately two 7% of add these total reported HCV product sales.

As a reminder, our royalties are calculated on a calendar year basis, therefore royalties for our fiscal first quarter ending December 31 are calculated at the highest royalty rates for the year.

And royalties for our fiscal quarter, ending March 31 will be calculated at 10% our lowest royalty rate tier in our fiscal year.

You can review our royalty tier schedule in our 2021 Form 10-K .

Recently Abbvie reported their global HCV sales were $1 7 billion in calendar 2021, and guided to $1 7 billion for global HCV sales in calendar 2022.

Moving onto our expenses for the three months ended December 31, 2021 research and development expenses totaled $48 5 million compared to $36 7 million for the same period in 2020.

The increase was primarily due to the timing of manufacturing in support of the Companys clinical studies and our virology programs.

General and administrative expense for the quarter was $9 5 million compared to $7 4 million for the same period in 2020.

This increase was primarily due to increased head count and compensation expense.

And answer recorded a minor income tax benefit related to the release of the state tax reserves for the three months ended December 31 2021.

Compared to an income tax benefit of $3 3 million for the same period in 2020.

And actual recorded a larger income tax benefit in 2020 than in 2021 due to the provisions of the cares Act of 2020, which enabled us to carry backlog prior year tax losses to offset taxable income in prior years.

This provision does not apply to periods ending after September 32021.

Net loss for the three months ended December 31, 2021 was $30 1 million or a loss of $1 48 per diluted common share compared to a net loss of $8 3 million or a loss of 41 per diluted common share for the corresponding period in 2020.

And at the end of the quarter was $347 7 million in cash and marketable securities.

<unk> expects that its current cash cash equivalents and marketable securities as well as continuing royalty revenue will be sufficient to meet the anticipated cash requirements.

The existing business and development programs for at least the next two years.

Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed.

I'd now like to turn the call back to the operator and open up the lines for questions operator.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.

Star one on your telephone to ask a question. Please standby, while we compile the Q&A roster.

Our first question comes from the line of Brian Abrahams of RBC capital.

Im sorry, RBC capital markets. Your line is open.

Hey, good evening. Thanks, so much for taking my questions.

I guess, just a couple on <unk>.

Three five im curious with some of the latest developments on the.

Progress with other protease inhibitors in this space I'm wondering how you're thinking about the overall competitive opportunity for two to three five.

Would you be thinking about maybe.

Focusing initially on patients who may not be able to take ritonavir, which <unk> of it is boosted by or are there. Other subpopulations you might initially focused on and then I'm just kind of curious it sounds like the.

The healthy volunteer study is on track to start this month.

What are your plans for how you might.

We build the safety and PK data.

<unk>.

Of course, given the.

The in vitro potency.

It's going to be very important in gauging, what the ultimate opportunity.

Probability of success of the drug can be thanks, so much.

Thanks, Brian Hi, this is Jay.

So yes, so the.

Yes.

Phase one in healthy.

About to begin.

Standard.

<unk>.

And we plan to.

Harvests that data.

In the first half.

With all of our other studies once we've got that data in hand, we'll find the appropriate mechanisms to tip.

Put it out.

Regarding the field and protease.

I would describe it as.

Very early yet.

There are.

A few entrants.

In this space, but as we know.

Not only.

And <unk>.

Virals, but in lots of other disease areas, it's not necessarily the first one in.

Okay.

The.

High quality.

Molecules that ultimately stand the test of time.

So again I think we've we built some <unk>.

Advantages tend to edp.

235.

From a potency standpoint from a PK standpoint from a tissue targeting standpoint.

And overall, we think the profile is a strong one.

Pete.

Very well along.

Longer timeframe regarding trials.

Beyond the phase.

Can you just one healthy study of course, we'll be getting into.

Key patient population.

There is the standard growth high risk.

Gross exposure prophylaxis et cetera.

And we would anticipate.

Yes.

Tapping into all of those opportunities.

Yeah. Thank you great.

Great. Thanks, and congrats on all the continued progress.

Youre welcome.

Thank you. Our next question comes from Eric Joseph of Jpmorgan. Your question. Please.

Hi, good afternoon with Hannah on for Eric Thanks for taking the questions from us.

First just wanted to get your thoughts on the severity of RSV symptoms and patients and how does that compare this season versus prior seasons.

Given the last since even on margins just wondering if theres any reason to think.

We might see more severe symptoms in patients this year.

And then also based on any unblinded looks at patient with baseline entering the RSVP study how should we be thinking about median age entering the study are there any pre specified subgroup analyses by age or other risk factors. Thank you.

So.

Maybe I'll, let Nathalie comment.

Some of these but.

Again, I don't think Thats necessarily anything special about this RSV season versus prior ones.

But I'll, let <unk> chime in.

Thank you.

So your question I think was about the same thing.

Thanks Sachin.

Worse than before.

I mean, obviously <unk> and <unk>.

Mind, you that Embeds Mckinsey <unk> 16.

Thanks Sidney.

And then just any that completed and we have not observed.

So then your Washington Reagan for sensors.

<unk> please.

As far as some of the kitchen.

Yes.

Alright and.

So if you don't have any data on median age I'm trying to cities at this current time.

So we are not sure I understood.

A question about <unk>.

Median age median age.

He is on the database.

Yes.

So I don't have Dominion teams, but if you look at the peak.

Yes.

On April <unk>.

Alright.

And so.

We would expect and think I would say if I have to guess I would say something goes wrong.

Yes.

Okay, and just wondering based on or assuming success in the RSVP trial.

Could you describe what next steps would look like would look like towards the pivotal program specifically how would a program in general about the prioritized relative to pediatric transplant population.

And what these trials be gating factors here and the phase II discussions with the FDA.

So we're going to we're going to focus post RSVP on high risk patient populations.

They fall mainly into three buckets the peds.

Transplant.

And then.

Other adult populations that are at higher risk so.

Those will be the.

The basic.

Patient populations that will be targeting two of the three of which we've got ongoing now.

Okay, great. Thanks for taking the question.

Youre welcome.

Thank you. Our next question comes from <unk> Rahimi of Piper Sandler. Please go ahead.

Hi, Keith Thank you so much for the update two questions for you if I can.

Question from a lot of our clients are just to understand how big that.

RSVP outpatient population and adult population so can you.

Maybe share with me some some market research that and onto has done how big is this addressable market.

The second question I have is in regards to the al protein.

<unk> inhibitor and train the clinic into the second half of 2022.

What is the strategy, there like which patient population would you be prioritizing that.

Are you going to go to <unk>.

Compromised or would you try adult population so thanks.

Thanks.

Answering my question.

Youre welcome.

Again the RSVP.

To RSVP patient populations otherwise healthy.

Otherwise healthy adults.

Which is probably not where the it's a great sort of staging trial.

It's a great bridge from our challenge study into other patient populations adult <unk>, but.

But it's.

It's not the main patient population that we would be.

Focus on instead of going after the three high risk loans.

You had mentioned.

That's not to say that of course.

In an otherwise healthy adults is presenting with RSV.

Couldn't be addressed by our drug it's just that on the.

On the route to approval and looking at.

The.

The critical markets to address on the registration pathway, it's really going to be on the <unk>.

<unk>.

Transplant and higher risk adult populations.

In terms of the <unk> protein, we just see.

We're going out.

Yes.

And RSV.

Can a very significant way as you know there aren't any approved therapeutics out there.

We hope to be the first are certainly among a small number of drugs that could be approved in RSV over a reasonable timeframe.

And.

We just.

We've been working on human respiratory viruses long before the pandemic because we saw it as a major.

Unmet medical need from a therapeutic standpoint, so when we saw this type of situation like that we usually.

Our doubling down on our strengths.

And.

So I think having an inhibitor.

938.

Great have high barrier.

Really potent.

It's once daily dosing, we've already demonstrated strong antiviral effect.

Should be.

Along the way.

Single agent.

But we also are looking at other direct acting antiviral mechanisms too.

Al protein the primaries.

It was another very interesting target from our replication perspective, so exactly how we took that and put it.

We pursued principally USA is another.

Single agent.

Let's say, maybe a different patient population perhaps.

You could think about different ways to position. These things if you have multiple of them or might and we put the two of them together in certain patient populations that might be very advanced in there.

Section.

Otherwise, it's very hard to treat maybe severely immune compromised patients that.

We're just struggle with anything.

And or might we use it to explore could we widened the treatment window.

Vinny versus any single agent alone, we all know.

And these.

And these infections viral infection.

Ticking clock do you have a defined window.

Based on what <unk> is and what mechanism youre pursuing on whatever that window is for one mechanism by putting two drugs together.

Hitting it harder earlier might you be able to shutting it harder might you be able to.

<unk>.

<unk> treatment a little bit longer.

Sure.

The therapy is.

As administered in so doing you would obviously be.

Increasing the addressable patient population, which would grow the market opportunity significantly. So I was just various different ways. Once you have.

A couple of tools that you could exploit them and we'll be we'll be looking into that as we evolve it but.

<unk> three is a very strong looking molecule.

Very potent.

Great PK again, we will have it in the clinic in the second half.

And we'll be tracking hopefully a very.

Successful other class way.

Using our in protein.

Edp 938.

Thank you Jane if I may ask a follow up question to that remark too hard. So I think the question from a lot of investors will come Andy how do we take the RSVP study and understand the translation and the more vulnerable population. So have you been able to provide some clarity how.

The first study could really derisked.

An RSVP ask.

Sure.

It's a.

Stepwise Derisking I think actually one of the most significant derisking event.

Sure.

Edp 938 happened in phase one healthy.

When we established that a really potent molecule with a high barrier to resistance could be administered.

Safely.

Deliver very nice drug exposures.

So that great it gave us great confidence going into.

Our first RSV infection study the so called challenge model.

Whereas you know it performed incredibly well.

All of that said that wasn't a virus that had been administered.

<unk>.

The patient volunteers under a controlled setting.

But it was still.

<unk>.

A real virus and real patient population size, but.

To demonstrate good viral kinetics and good safety.

In that setting was further de risking now will take one step further and doing it with real world virus.

Our real world infection, I should say so that.

People are.

Catching the stream that's going around presenting.

A very natural way to treat her.

And then we.

And then we treat them so I think it's.

It's yet another de risking step along an evolution rarely in.

In clinical medicine or clinical investigations do you have.

Such checkpoints to be able to.

<unk> established a new drug is actually doing what you had hoped for it to do.

And.

Granted the every patient population is slightly different.

And we will explore those as we do but again I think the profile of the drug the fact that it's a really potent antiviral.

And it appears to be working in every setting that we've put it in.

Bodes well.

Thank you so much.

Youre welcome.

Thank you. Our next question comes from Roy Buchanan of JMP Securities. Please go ahead.

Hey, great. Thanks for taking the questions.

Start on Edp 235, it sounds like the.

The next trial is going to be after the phase one is going to be treating patients in the second half of the year maybe.

Phase two three just curious.

If you guys plan to run multiple phase one.

In addition to the one that youre going to start this month and if so what those might be.

Well I mean, you're always doing other kinds of ancillary studies.

Along the way in development such as DDI studies is that what you were thinking of.

Anything else.

Yes.

I think those are the those are the main ones.

Once you have SCB I mean does he understand your exposure and tolerability.

You kind of know what youre dosing parameters are for phase. Two so you don't want to we don't want to be slowing that down to two three.

And so.

But theres always other.

Studies that you're doing in parallel.

In terms of DVR et cetera, et cetera, those will help down the road with special patient population.

Okay, Great and then I had one on <unk>.

501 for I guess, just curious maybe if you can speculate if that could be back into the clinic this year and what about.

I guess, how are you guys thinking about the combos.

Maybe there are some less ideal agents out there that you could partner with just to get more data on the compound.

What about running maybe a longer.

Combination trial with just a nuke some kols have mentioned to us that might be something worth exploring anything like that thanks.

No those are.

All good questions I think to answer your first and probably a direct question about that.

<unk> to be in the clinic this year.

I won't say that.

Couldnt be under any circumstance.

What I would say is we're really focused on.

We have 514.

Plays well with nukes done it on a one month study with the two making up a two drug combo.

We saw very nice.

Behavior in terms of the.

Two drugs, playing well together.

Safety profile and the combination we have observed.

Good antiviral effects et cetera et cetera. So it's the two two drug foundation now is just waiting for.

An ideal third.

Ingredient to be added and again.

We thought we had that one lined up before.

It turns out we don't know and so again, we're looking sort of both internally and externally.

For what I think.

We will hopefully be.

Great next combo ingredient I don't know.

I don't really necessarily want to be pursuing the lesser ideal ones for.

To me Thats.

Maybe just not a.

Not a good use of.

Capital, but.

As it pertains to.

We're a longer Nuc study I think was your other question could you do.

Core and a nuc for a really long time.

Probably not Super high up on our list, but it is something.

Dino Kols.

Could work overtime, we just have to be patient enough to run those kinds of studies in sort of launch that satellite.

And.

And I would hope that it reports.

Data back.

After a significant period of time.

Those are interesting studies that maybe should be done in some fashion some day, but again, our principal focus right now is.

Looking for something that would make for a great third agent to add such that we could get to a functional cure and hopefully in a more reasonable.

The amount of time.

Okay. Thanks for taking the questions.

Youre welcome.

Thank you. Our next question comes from Gregg Gela Roth Capital Your question. Please.

Good afternoon, and thanks for taking my questions and probably have some update I think we just have a few the first one is in that six to eight.

The study you had.

Symptom improvement that has been evaluated as a secondary end point and you did show some impressive reduction in nasal nuc is but I think I was just kind of curious about.

Can you kind of improvement being a primary endpoint for the phase <unk> study and if theyre going to be looking at Nathan.

Is that endpoint to patients and is it likely that youll be looking at some additional.

Measures app on the phase <unk> study.

Yes, so good question Zack both so yeah.

Phase.

<unk> studied the so called challenge study.

Did I think virology was the primary and symptom score with it.

The secondary and you can look at all kinds of.

Things, but.

I have to say one of the most.

Curious endpoints I've encountered in my career was.

Mucus weight.

Which you which turned out to be actually a very.

Interesting endpoint to look at that.

Actually mirrored other data quite well.

Said.

Yes.

<unk>.

Going as you advance.

Viral loads and later stage trials will be interesting, but symptoms, scoring is going to be more important on the on the path to registration and so there will be a number of different <unk>.

<unk> that are observed.

And that capacity that will add.

Add up to the overall theme.

Overall score.

It was one thing to do.

The.

The mucus accretion in the challenge study setting because these patients were domiciled there were indications.

It's very easy to collect all the clean exit.

And and weigh them.

In an outpatient setting is just that's just not practical right. So.

From.

RSVP onward.

That's a tough one.

Plenty of others still okay yep.

Thanks, and then I'm sure you get this one a lot, but just kind of curious about the five day treatment period, whether RSVP study I know you used the same treatment period in a prior study, but I was just wondering is that really long enough by basin.

Emily I have Dan inhibitor.

We've got new additional benefits can be gained from treating longer.

Well.

I guess you could never really know the answer to that without doing the study, but what we did find in this patient population.

That.

Yeah.

An RSVP, we think it will substantially mirrored the challenge.

Setting.

That's.

That should be we think that should be adequate when you get into.

Immune compromised setting.

RSV Tx.

The.

Meadow poetic cell transplant recipients are highly.

Immune suppressed in the first year post transplant and.

For these individuals who don't have the continent full immune system, helping them.

We are dosing longer 21 days in fact in that study. So there may be certain pockets or patient population, where you want to have the latitude to be able to dose longer but.

Ultimately the goal is.

To try to find a convenient dosing regimen.

You know that.

That is adequate and quite attractive and.

Generally speaking the shorter you can make that the higher we're going to have compliance.

The better the product profile is overall.

Got it with thinking that catlin, partly related to.

Cost of symptom burden to patients and then the last one here is just about the combo strategy. So if you want to do a combo with the <unk> now do you start with the Hunt inhibitor and then follow with the Allen do you just onboard both of them at the same time and then Im just going to squeeze in a question for Paul regarding mass revenues.

2021 revenues came in at low end.

He guided to at the beginning of the year leases 2 billion.

I think you came in at one seven and the <unk>.

Got up modestly for 2022 at about that one seven is I was just wondering how should we be thinking about.

No.

The cadence of revenues beyond 2022, how that has factored into your projections I think you set a runway for the next two years.

Well regarding what happens after 2022, it's really all up to the Covid.

Pandemic situation.

You're correct Abbvie has guided again for fiscal for calendar 2022, and $1 seven so they are expecting a flat year to 2021.

With no relief I guess from the Covid suppression impact what happens after that is really going to be up too.

We saw with variance instead of going to be a falling on Amazon.

Unknown at this point in time, and I would say that the two year guidance. We gave on cash was based upon our existing cash balances.

Our R&D and G&A guidance for fiscal 'twenty two.

And obviously, our Abbvie HCV royalties for the next fiscal year. So we look at that whole picture and we feel comfortable that we've got at least a two year run rate on cash.

And to answer your other question.

Doug.

We were doing a combination study we would have the drugs together at the same time.

Thanks, guys and thanks for the clarification.

Youre welcome.

Thank you. Our next question comes from Jay Olson of Oppenheimer. Your line is open.

Oh, Hey, thank you for the update and congrats on the progress.

There's been some discussion about using merck's move period here together with other antivirals and a combination approach to treat COVID-19 is that something you would consider with edp $2 35, and if so which drugs would you consider combining it with.

And then if I could ask a financial question.

Assuming <unk> guidance of $1 $7 billion in 2022.

Sales indicates that Maverick is stabilizing would that support a level of royalties that could continue to.

Support finances operating expenses for the foreseeable future.

Right.

Thank you.

Okay.

Paul.

I have just outlined the one seven.

Yes.

The guiding for the year.

As you know pretty much where they came in now and that's what's built into our forecast and we model based on their guidance.

And we do see that.

Uh huh.

Is propelling the.

No no.

The cash runway for that.

So that two year at least the two year period.

Based on current cash and anticipated.

Royalty revenue.

Regarding your <unk>.

Question about combos, so there's no indication right now that you'd need combos.

It is an acute viral infection.

We have potent anti virals.

It appears to be from what we consistency with.

Anti viral drugs going after covered the five day treatment.

Sort of the norm much like we had already established.

You know in our RSVP study.

So.

I would say that.

There could be the need for combinations down the road, but we don't we don't see that need yet, but nonetheless were.

Anticipating that having more mechanisms rather than pure down the road.

It could be a valuable things so.

We're not just working on proteins.

Sure.

When the pandemic started we started multiple different programs.

And we're hoping to harvest.

<unk>.

<unk> of other mechanisms overtime, so stay tuned on that front.

But in any event to your direct question.

See the.

The the need at this time to be doing those combination studies I'm not sure what you'd be trying to establish.

Okay. Thanks for taking the questions.

Youre welcome.

Thank you. Our next question comes from Brian <unk> of Baird. Please go ahead.

Hi, This is Luke Harman on for Brian . Thanks for taking my question and thinking about RSV development strategy from earlier questions. It seems like you are leaning towards.

The higher risk RSV populations for for the initial Registrational path.

In a situation that RSV is RSVP readout positively.

The RSVP than RSV Etfs studies might serve as pivotal for those indications and otherwise what can we expect the pivotal program to look like and would you choose to move it forward yourself. Thank you.

Yeah.

Yes so.

Again, I think once you have the data for RSV.

We'll have that information and of course, we'll have that discussion with the.

The agency.

That could inform how.

The future of the development program looks like on the path to registration, but at this time.

We are not currently expecting that those two studies are necessarily registration studies.

Is that helpful.

Thank you.

Yep.

I'm sorry did you have another question.

It was just other if those.

If those weren't right.

<unk>, what what would the pivotal development look like if you could speculate at all.

Yeah, I think the FDA I mean I think.

The FDA and the EMA.

Both.

<unk> focus on.

High risk as the <unk>.

Expedient path to approval.

So I think that's what.

That's what we need to that's what we need to do.

Alright. Thanks.

Yes.

Youre welcome.

Thank you. Our next question comes from Ron a breadth of S. VB Leerink. Your line is open.

Great. Thanks, So I wanted to circle back to your Covid asset. So for Q3 Fives do you have any thoughts on what percentage of patients out of a total eligible patient pool for antivirals might be really fully unable to take an antiviral that hazard ton of your boosting maybe possibly due to.

Drug drug interactions or things like that.

Okay.

Yeah, it's hard to get your hands on that exact number.

Yes.

Now maybe that is so.

That's more of a Pfizer question.

I think the.

But but what I will say is there is a.

A very substantial amount of the pharmacopeia that is.

Influenced by return of your.

Dosing so you just.

You just need to.

Now understand what other concomitant meds as patients are on and understand what potential impact.

Tom have you would have do.

Do you need to take people off certain skus need to dial them down or dose adjust.

In some instances where a ton of it can reduce exposure of other medicines.

Might you need to dose elevated other drugs the contemplated for that so there's just different things going on.

Need to be able to understand them and I think any time Ah patients on concomitant meds.

A quick question.

<unk> positions.

Physicians will need to understand.

Yes.

Explain to patients and then set up whatever.

And our plan of attack.

That you would need.

Need to set up to make sure everyone is.

Safely medicated.

You know our hope is to.

Just sidestep that that issue entirely.

Yes makes sense and then a quick one for RSV programs.

Curious for these phase two studies in pediatric transplant patients are there any other strategies or levers that you can pull to further accelerate the enrollment of those trials and when are you. What are you tracking to help you make that kind of decision if you want to apply those.

Additional strategies.

Yeah. So we're looking at new strategies, all the time.

Sure thing.

Yeah.

You've your catchment in terms of trial sites et cetera et cetera.

I think it's.

Just a question of how you adapt protocols to make it friendlier for.

Not friendly it's maybe the wrong word, but make it convenient for parents of peds too.

Enhanced enrollment not having.

Since the barriers there are extensive blood draws.

Other kinds of things that might you know.

Slow things down a little bit or or put people on the fence in terms of.

Coming in and participating in the trial like one of the other things just to during a pandemic the transplant recipients are probably among the.

The most cautious.

People right because they are immune suppressed they have to be you have to be incredibly careful post transplant.

Because of Covid.

So that that leases other.

Special challenges during a pandemic, but we're just going to have to just like with RSVP, we'd add to that.

Now was compromised by the pandemic for a while.

And we just needed to be ready with sites.

All of the appropriate spots for when things open up a little bit and then take advantage of.

Harvesting the.

The trial enrollment so.

Yeah.

I don't know that Theres any special trucks, we're just always trying to optimize enrollment to which way we can without jeopardizing the study of course.

Yeah.

Yes that makes sense very helpful. Thanks, a lot.

Youre welcome.

Thank you again to ask a question. Please press star one on your Touchtone telephone again Thats Star one on your Touchtone telephone task. A question. Our next question comes from Lisa Banco of Evercore ISI. Your line is open.

Right.

Hi, Thanks for taking my question.

I just wanted to get a sense that you'll have.

One data for the Covid program.

It looks like in the second quarter is that going to come before or after do you think the RSV data and then how quickly would you be.

Would you be.

Avon preparing to go into phase two slash three with your Covenant program from from.

Wrapping up the phase one.

Yes so.

I can't really I guess speak to which data.

Would come first we haven't.

<unk> begun dosing to three five soon.

And we'll.

We'll get into that study and get it.

Got it and get the various cohorts.

Progressed.

So depending upon how many doses, we have et cetera et cetera.

It's safe to say there.

Probably both Q2, but exactly.

Which one's first I can't really speak to today.

And then your other question, obviously, we will be preparing.

Sure.

The steps in phase III three after.

The phase one is to get into that as quickly as we can.

Making sure drug supply and sites et cetera, et cetera lined up.

So.

We'll be doing it as quickly as possible.

Starting in the second half.

So stay tuned on that front.

Okay and is that part of your assumption and your.

Your guidance and I'm just looking at R&D came in at around $49 million. This year I feel like you have a lot going on in your pipeline.

168.

I'm, sorry, $1 50 to 170.

Where like how do we kind of make the math work with all these studies going on is there something I'm not I know a couple of things are probably wrapped up in the fourth quarter.

We are wrapping up in the first quarter.

But given you are just starting.

Sure.

There is wind down.

Cost and so forth associated with.

Some of the Nash.

Studies et cetera, et cetera, they won't be obviously carried through the rest of the year.

We're.

But.

I think the plan.

This is still intact.

Yes.

And encompasses.

Or.

What we're aiming to do with these various programs.

Okay, and then just one wanted two questions on RSVP. The strain that you used in the challenge study is that like pretty representative.

Yeah.

How is it different.

Iris out there and I just it just came to my attention because you talked about.

The strains going around right now how similar are divergent constraints be for RSV and compared to what you. If you look on the challenge side, because thats a recall Europe was one of the more it seems like I don't know if the right word is very linked or whatever but you had one of the higher viral loads.

As I was kind of looking across the other challenge studies that it looked like you had a.

Pretty serious.

If I heard that you were.

Yes.

Standard.

Yes, no I'm, sorry to sort of indirectly.

It's a standard virus that has been used to Memphis strains and used in.

Multiple challenge studies I think yes, it may differ a little bit in terms of.

When people elected to dose.

We.

<unk> weighted to dose once the viral load had reached a certain threshold.

Not a certain number of days post inoculation. So we inoculated people in that challenge study with.

With the virus waited for the viral load we check people twice a day by RT PCR waited for the viral loads to start to climb up and waited until they got up to about three logs as I recall and then and then we started dosing.

So.

Obviously, if you dose sooner than that and we'll be dosing with a lower by railroad.

So that's probably the variable there.

I think ultimately.

It's a real virus.

But you need you do need to ultimately get out into the real world, where youre going to run into a different you know.

Slightly different strange he might have RSV, a you might have RSV b might be various.

Subtypes, along the way, but this is why we did a lot of work on <unk>.

Nickel isolate.

We're embarking on this study we werent using just lab strains of things et cetera et cetera.

Geographically dispersed.

<unk> virus.

Samples from different.

Different.

Patients in different seasons, et cetera, and we and we tested our drug against them.

The drug performed uniformly very well against the clinical expert so.

As a as a variable, but that's the real world real world infections and <unk>.

Among the things that RSVP will be.

Looking at but I think we've we've tried defense in as much as we could possibly fence in for Matt.

Derisking prior to gaming.

Okay and then just final question for me you mentioned you dose around three laws and I see from your graph here, Tom says that makes sense as to when you started dosing how does it relate to like.

Symptoms among patients start feeling symptoms and present, because I think that's where a lot of people are trying to figure out is like that window of opportunity you have I know it has to be within two days of symptoms.

Started dosing on day three here how does that's alright.

At three logs of viral load that relates to kind of at the onset of symptoms and that kind of thought well. If you. When we've got these slides in our corporate deck on our on our website is probably what you were looking at but if.

If you look at the symptoms.

By the time people were three logs in the challenge study.

As the trial, we're talking about is the challenged over time people were three logs. They were also starting to express at least one symptom.

And so they were becoming symptomatic. So then if you translate that into the into the real World Studies, now and say an RSVP.

What is the window what is the window that we could possibly be dosing patients.

We're not going to get people to come into your study or into the Doctor's office period.

Within 24 hours of sometimes right nobody does that.

Okay, languish, a little bit before they pick up the phone.

And so the earliest you might reasonably expect to catch a patient in a real world setting.

Within 48 hours and Thats, obviously, what we were able to do an RSVP that was back to the one that was one of the parts of the study were just doing it just to make sure we could catch RSV.

Patients within 48 hours of symptom onset and that indeed was the case.

That's the requirement for flu.

You have if you want a flu drug to work you've got to catch people.

In the first 48 hours or maybe 72 hours.

Of symptoms, if you want that drug to work, we don't know what the window is for RSV, it's probably more.

More forgivable.

Giving I should say than than flu, where it's a real tight window.

We're starting to get it.

<unk> now in the community with.

With regards to Covid right. It appears that you can maybe there was a five day.

Treatment window for Covid, where does RSV lie.

These are among the things that will ultimately be sorting out in various studies, but just for the very specific RSVP trial, we did put that 48 hour.

Constraints on there just.

Because we didn't have a basis.

To necessarily make it much.

Much longer if we just said well, let's assume it's like flu and then we can always go longer but you don't want to you don't want to.

You don't want to.

The wrong.

Guests at the beginning of your development.

Development.

So I think that's where it is you can't you can't practically do it shorter than 48 hours and we saw no reason necessarily to go longer than 48 hours.

So I think it's.

That's a good sweet spot.

Okay.

Thank you that makes sense.

Yeah.

Thank you at this time I would like to turn the call back over to Jennifer Viera for any closing remarks.

Thank you to everyone for joining us today, if you have additional questions feel free to reach out and contact us by email or give us a call at the office. Thanks, So much of a good night.

Goodbye.

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

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