Q4 2022 Roivant Sciences Ltd Earnings Call

Good day and thank you for standing by.

Welcome to Roivant's fourth quarter and fiscal year 2021 earnings call.

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Good day, and thank you for standing by.

Fourth quarter and fiscal year 2021 earnings call at this time, all participants are in a listen only mode.

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After the speaker's presentation, there will be a question and answer session.

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After the speaker's, presentation, there will be a question and answer session.

So for the Pryovance partnership with Pfizer, I believe there were actually two assets as part of that deal.

I would now like to hand, the conference over to your Speaker today, Paul Davis head of communications.

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Could you maybe talk a little bit about the second asset and kind of thoughts on that?

Please go ahead.

Yeah.

Good morning, and thank you for joining today's call to discuss financial results and business updates for the fourth quarter and fiscal year ended March 31st 2012.

If you're requiring further assistance, please press star zero.

And then on the updates on the LNP patent litigation, I guess any update that you can give in terms of timing, or when we could hear the court's decision on the motion to dismiss would be great.

Me too.

Paul Davis had a communications right Matt on the call today, we have Matt Klein, our Chief Executive Officer Richard.

I'd now like to hand the conference over to your speaker today, Paul Davis, Head of Communications.

Thanks.

Initial officer, Frank 40 are damn sure Eric Baker, our President and Chief operating Officer, and Mike Scott.

Please go ahead.

Sure.

Good morning and thank you for joining today's call to discuss Roivant's, financial results and business updates for the fourth quarter and fiscal year ended March 31, 2022.

Scott <unk>, President and Chief investment Officer.

For those dialing in by phone you can find the slides presented today as well as the press release updates on our IR website at Www dot.

I'm Paul Davis, the Head of Communications at Roivant.

Hum.

Tom will be providing the supply numbers, we present all along.

I would like to remind you that we'll be making certain forward looking statements during today's presentation.

Current views and expectations, including those related to our financial performance and the potential attributes of our products and product candidates.

We strongly encourage you to review the information that we have.

Including the earnings release and Form 10-K filed this morning for more information regarding these forward looking statements related risks and uncertainties.

On the call today, we have Matt Gline, our Chief Executive Officer, Richard Pulik, our Chief Financial Officer, Frank Tordy, our VAMP Chair, Eric Banker, our President and Chief Operating Officer, and Mayukh Sukhatme, our President and Chief Investment Officer.

Backline will review key business updates across worry about an advanced including the commercial launch of the Tama at Durham event as well as by advance.

Today, we will provide a financial update we will end the call with a Q&A session without further Ado I'll hand, it over to Matt.

For those dialing in by phone, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.todesture.roivant.com.

So, you know, the other asset in the Pfizer partnership was a selective TIC-2 with its own unique signature.

Thank you Paul and thank you everybody for joining this morning, it's exciting.

An exciting call for us it's our first our first 10-K as a public company. It's our third earnings call. So we appreciate everyone.

We'll be providing the slide numbers as we present to help you follow along.

We wanted to use this call to focus on REPO, given the fact it's a lead molecule and it's already in registrational studies.

Being here. This morning, so I'll start just briefly on slide four.

And talk a little bit about sort of what's going on in the business, starting with and I think everybody is.

I would like to remind you that we were making certain forward-looking statements during today's presentation that reflect our current views and expectations, including those related to our financial performance and the potential attributes of our products and product candidates.

So we don't have claims to share right now for Ropzacitinib, which is that selective TIC-2.

Familiar with what we have.

As of this month really that the commercial launch ongoing of Dicamba Kristian will provide us.

A brief update there although it's still early days are behind that we have a really exciting differentiated pipeline of clinical programs and we'll talk a little bit about some re prioritization. We've made there in part to make room for pricing.

We'll most focus on the combination.

New bands that we've announced this morning that is developing a drug that we'll spend a fair amount of time on today, but we also have our Archie preclinical discovery platform with our proprietary tools, including quite tolerant.

Working on a pipeline of preclinical programs against challenging targets I'll talk a little bit about some collaborations during the quarter there.

A number of sources of Asian metro potential upside, including using that IP portfolio and others all backed by a strong capital position with as of 331 at $2 $1 billion in cash cash equivalents on our balance sheet and a significant portfolio of public equity Stakes.

We strongly encourage you to review the information that we filed with the SEC, including the earnings release in Form 10-K filed this morning, for more information regarding these forward-looking statements and related risks and uncertainties.

Matt Gline will review key business updates across Roivant in advance, including the commercial launch of Vitama at DermaVant, as well as PrivaVant and NuVant we unveiled today, and he'll provide a financial update.

I'm sorry.

So we won't spend a ton of time on slide five on V camera today, because we just provided the update call a few weeks ago.

We'll end the call with a Q&A session.

And then on the IP question that you asked, I don't think we have a specific comment on the court's timeline for response there.

I think it's ultimately up to the court.

On the approval and it's too early to say much I'll say Ah we see strong early prescriptions recorded to date the IMS numbers are here.

Without further ado, I'll hand it over to Matt.

I don't think there's a prescribed timeline for it.

We've got some really good feedback from physicians on the label.

Thank you, Paul, and thank you, everybody, for joining this morning.

So they have discretion to decide when they want to.

And we're really excited what that looks like and then obviously, we're still focused on the atopic dermatitis program should readout in first half of next year, which we.

Expect to help us get to a blockbuster in both indications frankly in each indication and the one thing I'll say because it's really early days here. So while these numbers are exciting to us.

It's hard to make any forecast for what it means over time, we will provide a more fulsome update when we can I would for example expect this week to be a little flatter because our field forces out of the field for their sales meeting. So we'll we'll see it as it goes but again really promising early signs it's something that that.

Is an obvious and important area of focus for us and a major milestone that happened during this period, where we got our first commercially launch product now so excited about that excited about the team doing that work and look forward to seeing how it develops.

So.

Moving on to slide six.

I'll just reiterate something that's always been true for us, which is that we intend to operate from a strong capital position, we have as I'm sure you've seen $2 $1 billion in cash and cash equivalents as of $3 31.

We always work to run the business generally with over two years of runway and we're confident we're doing so right now and we continue to focus on that.

Part of that and responsive to the current capital markets and responsive to some of the opportunities we see outside including private.

It is now a program of ours.

Continue to watch our portfolio and we've implemented some companywide cost optimization of portfolio Wood preservation projects you can see on the right hand side here would you prioritize some programs.

Notably among them, probably our event our program in sickle cell disease, where we were just looking at the field there and trying to make sure. We we felt like we had it.

Portfolio are truly differentiated offerings and it was.

Hard for us to know, whether we were going to meet our squeaky clean.

Efficacy bar.

Hum.

Sure.

Move forward to slide seven I guess, one other point I'll make about capital for US is that we have always run our business.

With access to capital sources that go well beyond just the equity and in fact, if you look at our history.

And then half of the capital that we've raised and deployed since inception has come from sources other than what was in equity and we just listed a few of them here was a reminder, that we feel.

Very independent of the capital markets. One obviously is revenue from the kind of accretive I mentioned again, we expect this to be a potential blockbuster in multiple indications.

We've shown in our history, a number of important but cash generating partnerships, including out Washington deals like the Japanese rights to printer off jewelry pharmaceutical, including discovery stage partnership such as the ones that we've announced with Janssen.

Sprinting with B I.

And obviously for example, the DSP deal or a couple of years ago.

We have.

Jeremy It's IP estate, which is something that we know people are focused on and which we expect has the potential to be.

A source of significant capital depending on how that situation plays out and then we have monetize of ownership of our grants and other assets I'll call attention to date advanced 12% owner of today, which is something that obviously, we will be watching as that company continues to grow and evolve and something we've talked about a few times.

It's an exciting call for, us.

So, you know, we're watching for it in the coming months is what I would say.

It's our first 10-K as a public company.

So.

Jumping ahead to here.

I.

Just like to slide eight.

It's been a really exciting period for us just from a from a pure clinical execution perspective.

It's our third earnings call, so we appreciate everyone being here this morning.

Awesome.

We have 10 or more pivotal or pivotal enable the trial is expected to be up this year.

So I'll start just briefly on slide four and talk a little bit about what's going on in the business.

Seven of those are ongoing including at least for pivotal and we'll spend some time today talking about the programs and in Brexit NIM at present, and the three three or more additional trials expected to initiate this year.

Thank you.

So we have with some really exciting work to go in and we've mentioned a few times as really is.

An important period of clinical execution for us.

So on slide 910, and especially I start on slide nine.

We really we have programs that go beyond what are shown on slides at this point.

We're really focused on the opportunities in our pipeline and currently outside of our pipeline that have the opportunity to be really sort of differentiated and that are uniquely.

Available and interesting opportunities for us.

Starting with, and I think everybody is familiar with this, but we have, as of this month, really the commercial launch ongoing of Vitama Cream, and we'll provide a brief update there, although it's still early days.

And so we've got obviously be tablet dome event, where we continue to do both commercial and development work, we have been talking about but we've talked about a fair amount of immune event, we have sitting there but prior fans.

We have.

I'll list behind that that includes <unk> mill Nab, our anti GM CSF antibody on slide 10 kind of event that includes our R. R.

Our <unk> modulator with Hema Vance for transfusion dependent anemia, and low risk Myelodysplastic syndrome, and so on so.

Number of programs in our pipeline that we think are differentiated and interesting and really sort of.

Focused on the biggest value opportunities.

Behind that, we have a really exciting differentiated pipeline of clinical programs, and we'll talk a little bit about some reprioritization we've made there, in part to make room for PrivaVant, a NuVant that we've announced this morning that's developing a drug that we'll spend a fair amount of time on today.

Our next question comes from David Reisinger with SVB Securities.

So with that I'm going to switch gears, a little bit and I'm going to talk about something that I'm excited to talk about waiting for.

We also have our Chipta Clinic Discovery Platform with our proprietary tools, including Quasar and Vant AI, working on a pipeline of preclinical programs against challenging targets.

Your line is open.

I'll talk a little bit about some collaborations during the quarter there, and a number of sources of asymmetric potential upside, including the Xanadu IP portfolio and others, all backed by a strong capital position with, as of 3-31, $2.1 billion in cash growth on our balance sheet, and a significant portfolio of public equity stakes.

Yes.

For about six months to talk about this publically isn't even sort of getting it ready, but that isn't I'm excited to unveil prior fans.

Thanks very much.

A built in partnership with Pfizer to develop a potential first in class dual selective inhibitor of <unk> and JAK one.

So, we won't spend a ton of time on slide 5 on Vitama today, because we just provided the update, call a few weeks ago on the approval, and it's too early to say much. I'll say we see strong early prescriptions reported to date. The IMS numbers are here.

And I wanted to add my congrats on the submarine Pfizer transaction.

So if we start on slide 12.

I just wanted to before we go into Bryan itself just wanted to note that.

I think we've quietly built a portfolio of really high potential first in class or best in class in some cases only in class programs in immunology.

Across the <unk> portfolio that includes many of the I think.

People on this call already focused on broad characterization, we're looking for programs, where we have a clearer swimming lane that differentiation area of unmet need and sometimes that creates a clear clear.

Clearer swimming lane is in the biggest volume segment of the market as with the printer off where we saw a need for a novel topical an inflammatory skin disease, where otherwise systemic systemic agents had been the primary focus of the fields and sometimes it's in a specific indication of a set of indications, where we understand the biology, well and there's a clear potential bad actor as with many of our CRA indications are with GM CSF and sorry.

And then sometimes there's a disease that requires an agent that has a more pre trophic effect and we want to attack. It accordingly, and that's I think what you'll see with our approach to development at prior Pant, which I'm excited to unveil here today.

So we closed this deal last fall.

And we've been diligently working to get ready to make this announcement at such time, when we can say confidently that our phase three program in DM was underway, which we can now view.

<unk>.

We've gotten some really good feedback from physicians on the label, and we're really excited about what that looks like, and then, obviously, we're still focused on the atopic dermatitis program, which we'll read out in the first half of next year, which we expect to help us get to a blockbuster in both indications, frankly, in each indication.

So my questions are as follows.

We built a really phenomenal I won't be off by saying it was a really phenomenal working relationship with Pfizer there are repeat partner of ours and they've been really good partners to us here and so we're thrilled to partner with them to create private hands and I'm excited to talk about it.

The one thing I'll say is it's really early days here, so while these numbers are exciting to us, it's hard to make any forecast for what it means over time, and we'll provide a more fulsome update when we can.

I would, for example, expect this week to be a little flatter because our field force is out of the field for their sales meeting, so we'll see it as it goes, but again, really promising early signs and something that is an obvious and important area of focus for us and a major milestone that happened during this period where we've got our first commercially launched product now, so excited about that, excited about the team doing that work, and looking forward to seeing how it develops.

First, could you talk about the expected payer access ramp for Tepenerov?

And then how we as investors should think about net sales in coming quarters since it's going to take a while for payer access to actually take hold.

I'm talking about right now.

So on slide 13, where spend most of our time today talking about <unk>, which is the lead program at Pryor and it's a first in class dual inhibitor of tick two of JAK one.

Which we're developing.

<unk> specialty autoimmune diseases with high mortality and morbidity and with limited treatment options.

So moving on to slide six, you know, I'll just reiterate something that's always been true for us, which is that we intend to operate from a strong capital position. We have, as I'm sure you've seen, $2.1 billion in cash and cash equivalents as of 331.

Then second, with respect to court action on the LNP litigation ahead, could you just talk about potential timing and how we should think about developments to watch?

Well go through each of these points in greater detail during the call, but first of all the molecule has all sorts of characteristics that we have generally really like first of all it's got.

We've implemented some company-wide sort of cost optimization and portfolio reprioritization projects, and you can see on the right-hand side here, we've deprioritized some programs, notably among them probably our event, our program in sickle cell disease, where, you know, we were just looking at the field there and trying to make sure we felt like we had a portfolio of truly differentiated offerings, and it was hard for us to know whether we were going to meet our squeaky clean efficacy bar.

So if you move forward to slide seven, I guess one other point I'll make about capital for us is that we have always run our business with access to capital sources that go well beyond just equity, and in fact, if you look at our history, more than half of the capital that we've raised and deployed since inception has come from sources other than equity, and we've just listed a few of them here as a reminder that we feel very independent of the capital markets.

And third.

I don't know if Richard's on the call, but it would be helpful to understand how we should, be thinking about cash flow in the upcoming fiscal year, specifically operating cash flow or operating cash burn, I mean.

The unique dual targeting mechanism and we will go into why that's important from a biology perspective.

We know that it is a highly active agent we have a very robust efficacy dataset covering a wide range of indications with successful phase II studies already under our belt.

We have a distinctive development strategy in specific indications that plagued the strength of the drug.

And elegantly work around some of the well known current limitations in the JAK pathway.

And we have two ongoing registration programs with the first readout expected in the second half next year.

And finally, the long tailed asset composition of matter going from roughly 2039, so exciting and exciting program to have to have in our hands.

Thank you.

On slide 14, I want to start with a little bit of a review of the relevant biology, So the Jack family, Jack 123, and tick to generally signals via peer wise combinations. So a dual inhibitor of <unk> and JAK. One allows you to immediate signaling of a number of inflammatory cytokines represented by the boxes shaded in yellow on the left and <unk>.

Thanks, David.

Those are all great questions.

<unk> really and importantly.

And it is expected to more robustly suppressor cytokines in the upper right hand corner, namely interferon Alpha and beta of most importantly, as that's just the specific dual TIK two and Jacqueline integration is relevant to a signature of autoimmune disease, we can suppress interferon alpha and beta and strongly and also hit interferon Gamma IL six IL 12.

I appreciate it.

You know, on to pin her off, pay her ramp, you know, I think we've commented a little, bit in response to some of the other questions here.

You know, we've said our main focus is on high-quality coverage.

What that means is we're prepared to do the work to get the covered claims through, to, get payers to pay attention to the program, and that's what we're doing now.

'twenty, three which are particularly relevant in the diseases, we are pursuing.

So we are most focused on, as I think we've said a few times, script volume during this, period of initial launch, and expect that to last for a little while here.

It's worth noting again.

This is not simply another tick two or another jackets are unique small molecule with a profile that allowed us to tailor our COO.

<unk> precision clinical development plan and its also worth noting this is the only dual inhibitor of take two and Jack one.

Kind of late stage clinical development. So we think a really interesting opportunity.

So on slide 15, and some of these studies have already been made public and some of it not.

The one thing that we're excited about peripheral has a really robust set of efficacy.

A range of autoimmune indications, we know that it's a highly active agent Sean.

On P values in multiple studies run by Pfizer and every indication that if I didn't have shown P values and every indication tested by Pfizer so far.

We have an extensive safety database as well with exposures in over 1000 subjects and patients. The show's profile is consistent with the approved JAK inhibitors, just as you would expect.

And then what we said is that we expect to have that coverage online kind of in the 12, month timeline, and that's when we would expect gross net to ramp up and normalize.

And I would say we'll be prepared to provide sort of better specific guidance on what we, think normal gross net will look like for us once we have a little more visibility into those contracts and so on.

So then if we jump to slide 16 kind of what's our strategy here what are we doing and obviously the world is watching.

Watching what's happening with Jack where do we think we have an opportunity.

You know, one, obviously, is revenue from the McCabe cream I mentioned again.

You know what.

We talk to Pfizer about our interest here, but we were particularly interested not in sort of the typical Jack markets, where theres more competition, both from small molecules and frankly from biologics, but to go after a set of indications where we were.

We expect this to be a potential blockbuster in multiple indications.

We've shown in our history a number of important cash-generating partnerships, including out-licensing deals like the Japanese rights entrepreneur offer to refarmaceutical, including discovery-stage partnerships, which are the ones that we've announced with Janssen, with Blueprint, and with BI, and obviously, for example, the DSP deal of a couple of years ago.

We have Genevieve's IP estate, which is something that we know people are focused on and which we expect has the potential to be a source of significant capital, depending on how that situation plays out, and then we have monetizable ownership of our Vance and other assets, and I'll call attention to DataVan, which we are a 12% owner of today, which is something that, obviously, we will be watching as that company continues to grow and evolve, and something we've talked about a few times.

We felt there was a.

A clear differentiate opportunity one where we felt the biology of the disease indicated that both take two and jacqueline to contribute to efficacy to where the diseases had high morbidity and mortality in an urgent need for novel therapies, and three where there weren't a lot of therapies, including <unk> and all of our cases, no oral therapy and this led us to a series of.

So, jumping ahead to here, you know, to slide eight, it's been a really exciting period for us, just from a pure clinical execution perspective.

Indications some of which you can see on this slide with you overall opportunity was high we felt for a new leading treatment option in orphan disease markets that are largely on the crowded.

We have 10 or more pivotal or pivotal-enabled trials expected to be up this year.

So I think stay tuned on that topic.

Let's turn them, we'll talk about the first couple of these more closely and obviously more to come in terms of additional indications over time with this program.

Then on the L&P litigation, you know, I think a similar answer to the prior question here, I think the district court has discretion on when they respond.

The next major action there is the district court's response to Moderna's motion to dismiss. The district court has some discretion there, but in general, they tend to respond within, months, so that's something to specifically watch out for.

We think the IQUITAS situation is of less direct interest, but that's obviously also, ongoing, and we'll get some feedback from the court there.

And then, you know, beyond that, I don't have a lot to comment on right now or on any other, you know, possible movement there, but those are the things we're watching most closely.

And then, you know, Richard is on, so I can hand it over to him for any additional comments, on operating cash flow.

But I think, you know, while we haven't given specific sort of cash flow statement and metric, guidance, you know, I think you can look at where things have been, and you can look at the sort of runaway guidance that we're giving overall, and back in a little bit to kind of what we think things are going to look like from an operating cash flow perspective.

Seven of those are ongoing, including at least four pivotals, and we'll spend some time today talking about the programs in brexit and prior Vance, and with three or more additional trials expected to initiate this year.

Richard, I don't know if there's anything you would add to that.

So I'll start on slide 17, with dramatic my situs, which is a rare chronic immune mediated diseases of muscle and skin affects about 37000 adults in the U S alone.

So, we have some really exciting work to go, and we've mentioned a few times, this really is an important period of clinical execution for us.

So, on slides nine and 10, and especially as I start on slide nine, you know, we have programs that go beyond what are shown on these slides at this point, but we're really focused on the opportunities in our pipeline and currently outside of our pipeline that have the opportunity to be really sort of differentiated and that are uniquely available and interesting opportunities for us.

And so, we've got, you know, obviously V-TAM at Derm-E-Vant, where we continue to do both commercial and development work.

We have Batocla-Mavit.

Thanks for the question.

Look, we haven't provided guidance for the year specifically, but I'm very pleased with, a lot of the reprioritization we've done, you know, this quarter, and as we think about the portfolio, I think we have a really high bar here as we move things forward.

Thank you very much.

We'll have data emerging from us, from competitors, and we'll put the same laser-focused lens, on taking additional programs forward as data emerges from our programs and externally.

And you know, certainly, as we ramp up the Vitama launch, you know, and the AD data comes, through, you can think about some of the additional spend for launch down the line.

And then, as we said, for meter vans, we have the additional phase three trials that, will be coming through that you'll see kind of by the end of the year, and some of the other savings that we've talked about should confidently land us at the two-plus-year runway, but you know, we're not providing one-year guidance.

We've talked about a fair amount at Immune-E-Vant.

Thanks, Dave.

Hallmark symptoms around the skin and muscle painful skin rashes muscle weakness.

We have Brexit-Mib at Pry-E-Vant.

A list behind that that includes Nomilumab, our anti-GMCF antibody on slide 10, and Kinovant, that includes our SA3B1 modulator or Hemovant for transfusion-dependent anemia and low-risk myeloplastic syndrome and so on.

So a number of programs in our pipeline that we think are differentiated and interesting, and really sort of focused on the biggest value opportunities.

So with that, I'm going to switch gears a little bit, and I'm going to talk about something, I'm excited to talk about.

Our next question comes from Stav with H.C. Wainwright.

Often with disfigurement and disability associated with them.

Your line is open.

Cycle of inflammation with damage muscle in damaged vascular endothelium tends to lead to damage in multiple organ systems, including pulmonary and cardiovascular systems that theres significant mortality. A majority of cases are chronic in demand at chronic steroid therapy and aren't well controlled even with that.

Hi.

Good morning.

Thanks for taking the questions.

Matt, maybe to start, I know you highlighted that you've gotten some positive feedback, on VITAMA in the early days.

Yes.

I'm just curious, when we think about the sort of selling points that you've had for, DePinerol, for VITAMA, is there anything in particular that is resonating with physicians or sort of really standing out to them in the early conversations?

So, in the last couple of weeks, we've actually done speaker trainings.

We've been out to sort of top thought leaders on psoriasis.

I've been waiting for about six months to talk about this publicly as we've been sort, of getting it ready.

And the only approved therapy apart from steroids and corticotropin is a V I G.

Would you just got approved recently.

It's an advance in the field, it's not a perfect solution, it's IV with a cumbersome administration. It gets dosing for like two to five consecutive days each month.

With infusion times are pretty long on each day, and with a number of side effects, including an elevated risk of thrombosis.

So there's a high need for novel targeted therapies that address underlying dms type of biology in a chronic refractory patient.

So if you jump to slide 18.

Yeah.

There is some evidence already the JAK inhibition alone has efficacy indeed.

N D M. So on the left hand side. There's this store study in refractory dermatomyositis worth of JAK. One inhibitor were studied in the disease, notably the endpoint here total improvement score T. I S. Use the was the primary endpoint in this study is an open label study with the primary endpoint in this study and is the scale use regulatory approval and you can see the at the mill.

Blue line is the median improvement there we got to this Jack and have you ever got to a roughly 40 point improvement.

We're going to get every single patient improved its all the hash lines on here.

Secondary endpoint analysis also showed robust improvement in other realms, where C D ASI and storage variability.

For those patients that are steroid dependent.

And it's worth noting the median improvement N T. I S. You was similar to that which was seen in <unk> leading to its recent approval I Love Christmas JAK study was an open label study.

We also compiled a bunch of case reports.

Where we had.

Documented and published in literature about 145 cases of DM and juvenile D. M that were treated with various JAK inhibitors and it was 140 to 137 were considered clinical success by their respective investigators again. This is not a controlled study, but this is just supportive evidence for.

For JAK inhibition is being relevant to the field and many of those case reports noted objective and subjective improvements, including in the muscle skin and lung.

I think in general, you know, what are we getting?

So I think back to the point that I made about sort of why we are in this field at all or why we're excited about representative on slide 19, you know I think it's important to think about where the disease biology fits in here and again here dual inhibition of <unk> and JAK. One as a reminder provides optimized suppression of type one interferon, which is the key pathogenic cytokines in dermatomyositis.

People were excited about the remittive data.

Obviously, that's something we expected.

I'd say, you know, the cosmetic elegance of the cream itself, that's the kind of thing, that people can tell immediately on use.

But that is I'm excited to unveil PriAvant, a vant built in partnership with Pfizer to, develop a potential first-in-class dual-selective inhibitor of TIK2 and JAK1.

I'd say we've gotten good feedback on that and on tolerability right out of the gate.

Yes, mostly confirms the survey data that we previously shared.

And, you know, we're excited to see that patients want to use it again.

And then the other thing, I'd say early indications from the field, you know, onset of action, its benefit, efficacy benefit.

I think these are the kinds of things that you would expect to hear in an early launch, but we're pretty encouraged by it.

So if you start on slide 12, I just wanted to, before we go into PriAvant itself, I just, wanted to note that I think we've quietly built a portfolio of really high-potential first-in-class or best-in-class.

Okay, great.

I won't cover all of them journal in the slides a couple of lines of evidence for that one is that elevated levels of type one interferon found in the relevant organ systems of DM patients.

In some cases, only in-class programs in immunology across the right-hand portfolio, that includes, many that I think people on this call are already focused on.

There's broad characterization.

And then just as a follow-up, and I might have missed it, could you just maybe talk a little bit about the origins of the Beppo transaction with Pfizer?

We're looking for programs where we have a clear swimming lane, the differentiation area, of unmet need.

Was this an asset that you had identified and reached out to them, or did they reach out to you to discuss it?

And sometimes that clear swimming lane is in the biggest volume segment of the market, as with Dupinerov, where we saw a need for a novel topical and inflammatory skin disease, where otherwise systemic agents have been the primary focus of the field.

I will hand over the origin story to Mayuk.

And then sometimes it's in a specific indication or a set of indications where we understand, the biology well and there's a clear potential bad actor, as with many of our SCRN indications or with GM-CSF in sarcoid.

Sure.

And then sometimes there's a disease that requires an agent that has a more pleiotropic, effect and we want to attack it accordingly, and that's, I think, what you'll see with our approach to development at PriAvant, which I'm excited to unveil here today.

Yeah, I mean, I think that you should assume that, look, I think we have a great working relationship, with Pfizer, we have, you know, great working relationships with other pharma companies as well, and it's almost more of an ongoing dialogue than, you know, an outreach or a specific outreach in either direction.

But this was obviously, you know, a striking, I think, really unique drug that I think we had seen their data evolve and emerge, you know, for a period of time.

I'm just curious, how are you thinking about some of the bigger indications that we already have some proof, of concept data on or sort of some early clinical data, you know, are those worth pursuing or something that you think about down the road?

The second is type one interferon gene signatures.

And we're excited that we're able to, you know, kind of have a win-win collaboration, and we're just getting started.

Yeah, thanks.

And I guess just maybe, Matt, final question on Beppo, when you think about sort of prioritization, obviously you're starting in dermatitis and lupus.

It's a good question.

And obviously the data that we have are highly compelling across a range of indications.

I think they highlight just how strong a molecule it is.

Correlate with D M disease activity go down with successful therapy and go up as disease worsens.

Direct exposure type one interferon to Myotube solicitor pathogenic response.

We know that hitting both tick to inject one seems to be required for maximal type one interferon expression and finally in whole blood assays, we see evidence that.

It does exactly what you think it should with greater type one interferon suppression that TIK, two inhibitors or JAK inhibitors.

On Slide 20. In addition to type one interferon dual inhibition of Arctic two and Jack when also uniquely suppress other DM associated pathogenic cytokines interferon gamma IL 23.

<unk> IL 12, and the signature is important and again you can see in this whole blood assays, the Brexit and the burst suppression that compares favorably.

Overtake two inhibitors and JAK inhibitors.

So we closed this deal last fall, and we've been sort of diligently working to get ready, to make this announcement at such a time when we could say confidently that our phase three program in DM was underway, which we can now do.

You know, I think right now we're focused on the development strategy that we've laid out here, not just in these indications, but frankly in other indications that rhyme with these.

So on slide 21, here's a schematic of the program that is currently underway.

We built a really phenomenal – I want to just lead off by saying we built a really, phenomenal working relationship with Pfizer. They're a repeat partner of ours, and they've been really good partners to us here.

I think there are many.

Regulatory alignment on the design and we believe that if these data are robust this single phase III, along with all the other sporting events around the compound.

And so we're thrilled to partner with them to create PriAvant, and I'm excited to talk, about it – talk about it right now.

So on slide 13, you know, we're spending most of our time today talking about PrepaCytinib, which is the lead program at PriAvant.

It's a first-in-class dual inhibitor of PIK2 and JAK1, which we're developing for specialty, autoimmune diseases with high mortality and morbidity and with limited treatment options.

Be sufficient or could be sufficient for approval.

So we'll go through each of these points in greater detail during the call, but first, of all, the molecule has all the sorts of characteristics that we have generally really liked.

First of all, it's got a unique dual targeting mechanism, and we'll go into why that's important, from a biology perspective.

And so, you know, I say that's our initial focus, and I think you can expect us to continue to pursue that line.

Second, we know that it is a highly active agent.

So.

Moving to lupus now on slide 22.

So this is obviously, a pretty well known disease among the investor community.

We have a very robust efficacy data set covering a wide range of indications and successful, phase two studies already under our belt.

We're watching the field closely and looking forward to continuing to provide updates as we get going.

We have a distinctive development strategy and specific indications that play to the, strength of the drug and elegantly work around some of the well-known current limitations in the JAK pathway, and we have two ongoing registration programs with the first readout expected in the second half of next year, and finally, it's a long-tailed asset with composites of matter going through roughly 2039. So an exciting program to have in our hands.

It continues to be one of the biggest autoimmune markets, obviously and it continues to have enormous unmet need the classic hallmark is this sort of butterfly rash, but it can result in symptoms in basically all major organ systems and it has elevated mortality and there's no question, there's unmet need here, it's widely recognized by patients by physicians and by regulators.

On slide 14, I just want to start with a little bit of a review of the relevant biologies.

So the JAK family, JAK1, 2, 3, and TIK2, generally signals via pairwise combinations.

So a dual inhibitor of TIK2 and JAK1 allows you to mediate the signaling of a number of, inflammatory cytokines represented by the boxes shaded in yellow on the left.

Benlysta is an approved therapy. It would move back in 2011, which is a huge achievement was the first drug approved.

And particularly and importantly, it's expected to more robustly suppress the cytokines in, the upper right-hand corner, namely interferon-alpha and beta, most importantly.

In decades, and the indication but.

But it's approved in spite of a relatively modest effect on placebo adjusted Delta somewhere between 10% to 14%.

And a full amount was approved last year.

We've really one positive studies the other major.

Missouri study.

Outright failed and look worse than placebo, but after you kind of looked at the totality of data again, there was significant unmet need in the phase II also look supportive until it was approved and so clearly lupus is not a not a salt issue.

You know, we think we can...

And I'd say, a common conclusion is that almost nothing ever works, but actually we think that a lot of study failures have resulted from an attempt to improve upon what's already been successful rather than.

Repeating what works and what we can learn a lot from benlysta in particular.

Which was positive in all of its phase III studies despite.

So some challenges on the efficacy side.

Edit.

And so yeah, I think it'd be fair to conclude we view this as a pretty high risk proposition that we have some humility tackling yet but also there are some important lessons and what's likely to work and we think that we can design a study that maximizes chances for.

We can generate...

Yeah, go ahead.

For success.

So.

On slide 23 for starters, we do have recent data for what happens if you inhibit JAK one Arctic two in lupus.

As such, the specific dual TIK2 and JAK1 inhibition is relevant to a signature of autoimmune disease.

That's perfect, yeah.

And I guess Matt is following.

Should we think about this as sort of an asset, similar to what we've seen with Patakomab in terms of just a rollout of new indications, or do you think that these two are gonna be the ones that we should focus on for some amount of time?

In these patients and the good news is there signs of efficacy with the JAK one inhibitor as you saw on the phase twos and one of the phase III bear Sidney.

And then also.

We announced phase two of them to grab a pseudonym which showed some noisy dose response, but again separation with each dose arm over placebo.

He is a good supporter of drug efficacy.

There's obviously nuances in these study designs and some of them. We think made the data look more noisy than that and it really was.

I think you should focus on these two first, but you should expect us to continue to announce some further opportunities as they crystallize.

So.

On slide 24, I won't belabor this point, but we did just want to show your cross study comparisons of breadth versus that those couple of drugs.

Obviously, it's a competitive area.

So like Patakomab, we're focused on making our decisions, executing on them and talking about them in the right order.

Worth, noting all of these divisions have very different biology for lupus, but just looking at the slide you can see that rapid was really begun.

But I think you should expect us, to continue to pay attention here.

And it compares favorably to do cranberry each of these indications. So we think we have an opportunity to differentiate.

And look, we think that this should work in indications, a variety of indications of high morbidity and mortality with few approved therapies.

The biology after even play further in our favor again, given the unique signature of our drug like dramatic by scientists lupus is known to be a type one interferon driven disease.

We can suppress interferon-alpha and beta strongly and also hit interferon-gamma IL-6, IL-12, and IL-23, which are particularly relevant in the diseases we're pursuing.

And we're looking at areas, where there's highly inflammatory pathobiologies where specifically dual inhibition and TIK2 and JAK1 would be expected to provide greater efficacy than either alone.

And we think there's multiple to choose from, in addition to the two that we've mentioned today.

And Brett Boe.

So it's worth noting again, this is not simply another TIK2 or another JAK.

May provide sort of best in class depression of type one interferon signaling.

The other cytokines implicated in such as Al sex, IL 12, and IL 23.

So our strategy builds on evidence in the last 20 years definitely has specific pathways that are relevant and also underscores that you can't go after just one access for for efficacy if you want robust efficacy.

It's a unique small molecule with a profile that allowed us to tailor a customized precision, clinical development plan.

Format provides evidence that type one interferon inhibition provides activity in SLE.

And it's also worth noting, this is the only dual inhibitor of TIK2 and JAK1 in any kind, of late-stage clinical development.

So we think it's a really interesting opportunity.

We're the only one the only oral drug to hit this axis as robustly and then Barry provides evidence that JAK <unk> inhibition provides modest activities.

Modest activity nationally, which includes our IL six and interferon gamma.

<unk> will provide evidence that <unk> inhibition or reductions in out 12 months out 23 also provides some activity in SLE and we're the only drug to hit this full unique signature.

So.

So on slide 15, and some of these studies have already been made public and some have, not.

Thank you.

But one thing that we're excited about, PREPRO has a really robust set of efficacy in a range, of autoimmune indications.

On slide 25 years, the Lupus study design, it's a large global phase III study is all of the design features you'd want from pivotal.

We know that it's a highly active agent.

Our next question comes from Jenkins with Goldman Sachs.

It's shown p-values in multiple studies run by Pfizer in every indication that Pfizer, or sitting there, but shown p-values in every indication tested by Pfizer so far.

And we have an extensive safety database as well with exposures in over a thousand subjects, and patients that shows profiles consistent with approved JAK inhibitors just as you'd expect.

Your line is open.

So then if you jump to slide 16, kind of what's our strategy here, right?

Yeah, good morning.

Close to fully enrolled actually so that's an important piece of news.

What are we doing?

You highlighted at the end there, that you have this increasingly broad immunology portfolio.

Obviously, the world is sort of watching what's happening with JAKs, but where do we think, we have an opportunity?

And of course, these are across different bands.

And we're using a 52 week end point, so we expect topline data in the second half of next year. So quite soon and then it is important to note here a feature of our collaboration with Pfizer as the Pfizer is sharing in the expense of this study it was already in flight and we launched private but in total.

So I'm curious, could you talk about any potential synergies, across the set of bands?

You know, we talked to Pfizer about our interest here and that we were particularly interested, not in sort of the typical JAK markets where there's more competition, both from small molecules and frankly from biologics, but to go after a set of indications where we felt there was a clear differentiate opportunity, one, where we felt the biology of the disease indicated that both TIK2 and JAK1 would contribute to efficacy, two, where the diseases had high morbidity and mortality and an urgent need for novel therapies, and three, where there weren't a lot of therapies, including in all of our cases, no approved oral therapy.

Whether that's an area we should expect you, to continue to focus on as you expand the portfolio?

Yeah, thanks, Corinne.

It's a good question.

I think we see it in our diligence.

I appreciate your listening.

I would say a couple of things.

First of all, we continue to not wanna pigeonhole ourselves, to specific therapeutic areas.

And this led us to a series of indications, some of which you can see on this slide, where, the overall opportunity was high, we felt, for a new leading treatment option in orphan disease markets that are largely uncrowded.

So I think you'll continue to see us taking opportunities, more broadly than just immunology.

There are obvious benefits to having a concentration, or some elevated expertise in an area.

So let's turn and we'll talk about the first couple of these more closely and obviously, more to come in terms of additional indications over time with this program.

This ended up being a really highly capital efficient bet for Logan to make relative to running an entire lupus registration quality study from start to finish.

We're excited we're excited to partner with Pfizer on it and then on the back of this if successful will just be one study away from approval.

Quite large market.

So I'll wrap up on private.

On slide 26, with just a recap partnerships so pfizer.

As is sometimes the case with our really important partners advance owns an equity interest of 25% equity interest in <unk>.

If it develops the drug and owns commercial rights to Brett representing them in the U S and Japan and we are.

You have similar rights to a mid stage two inhibitor.

This was a capital efficient deal for us. So there was a nominal $10 million upfront, which actually included the purchase of inventory of drug in hand.

No regulatory milestones at all in a single commercial milestone.

Theres, a tiered sub teens royalty on net sales in our territories themselves that are booked by Pfizer outside of our territories at a slightly lower but conceptually similar single milestone royalties flowing back to play it back to us.

We see it in our track record and people's understanding, of our ability to execute these kinds of deals and these kinds of programs.

We are thrilled to unveil this program. It's emblematic, we think of our ability to work with partners often repeat partners on high impact therapies with creative development strategies, and working capital efficiency and I'd say, obviously, a little bit of a contrarian ism and moving into this area.

Ultimately, if there are overlaps, in commercial footprint, we have the ability to do interesting things through the Vant family and working with Vant management teams to maximize synergistic value.

But we also have the flexibility, to treat the programs as separate.

So I would say we get benefit from focusing, and the flexibility to treat the programs as separate.

So I would say we get benefit from talent mobility.

We get benefit from leadership.

With what everyone else sort of focusing on but we think it's going to deliver a meaningful therapy to patients in a range of diseases with high unmet need. So we think this will be.

We get benefit from sharing ideas across the family.

And I think down the line, as we get closer to commercial in some of these programs, we have the ability to think creatively about collaborations and the flexibility to do what makes sense across the family.

One of the anchor programs in our portfolio in the years ahead and look forward to providing further updates.

As we continue to execute.

So I'll start on slide 17 with dermatomyositis, which is a rare chronic immune-mediated disease, of muscle and skin.

And I'll highlight one of the things in particular, which is talent mobility.

So I'm.

It affects about 37,000 adults in the U.S. alone. Hallmark symptoms are on the skin and muscle, painful skin rashes, muscle weakness, often, with disfigurement and disability associated with them.

You know, we talked about deprioritizing, some programs today. I think one of the great things about the Vant model, is that we have the ability to take, to offer top talent from Vants, from programs that we deprioritize opportunities in other places around the organization.

And that's something that's always been core to our model.

I'm going to.

Real quick with you a couple of other updates that was the main new item for the period.

The cycle of inflammation with damaged muscle and damaged vascular endothelium tends to, lead to damage in multiple organ systems, including pulmonary and cardiovascular systems.

And it's something that a concentration, in a given therapeutic area makes even easier.

But I just wanted to give a couple of quick updates on some other things going on around the portfolio and then we'll wrap up with a brief financial update and then open the line for questions. So.

There's significant mortality.

And so I think it's something we're excited to have.

Jumping ahead to slide 28.

A majority of cases are chronic and demand chronic steroid therapy and aren't well-controlled, even with that.

Thank you.

So let me go to slide 28, we've talked a little bit about this on earlier calls in your press release I'll just point out at this point, we've done multiple strategic partnerships that validate the quality of our discovery pipeline in our discovery platforms, our discovery tooling.

And the only approved therapy, apart from steroids and corticotropin, is IVIG, which, just got approved recently.

It's an advance in the field.

And I'm only showing the questions at this time.

It's not a perfect solution.

It's IV with a cumbersome administration.

It gets dosed, I think, for like two to five consecutive days each month with infusion, times that are pretty long on each day and with a number of side effects, including an So there's a high need for novel targeted therapies that address underlying DM pathobiology, in a chronic refractory patient.

You can see the endpoint here, total improvement score, TIS, was the primary endpoint in this, study. It was an open-label study. It was the primary endpoint in this study and is the scale used for regulatory approval. And you can see the blue line is the median improvement there.

So if you jump to slide 18, there is some evidence already that JAK inhibition alone, has efficacy in DM.

This JAK inhibitor got to a roughly 40-point improvement. It's worth noting that every single patient improved.

It's all the hash lines on here.

So on the left-hand side, there's this STIR study in refractory dermatomyositis where, a JAK1 inhibitor was studied in the disease.

The secondary endpoint analysis also showed robust improvement in other relevant square, variability for those patients that are steroid-dependent.

Again, this is not a controlled study, but this is just supportive evidence for JAK inhibition, as being relevant to the field.

And it's worth noting the median improvement in TIS here was similar to that which was, seen in IVIG, leading to its recent approval, although, of course, this JAK study was an open-label study.

And many of those case reports noted objective and subjective improvements, including in, the muscle, skin, and lung.

We also compiled a bunch of case reports where we had seen documented and published in literature, about 145 cases of DM and juvenile DM that were treated with various JAK inhibitors. And of those 145, 137 were considered clinical success by their respective investigators.

So I think back to the point that I made about sort of why we are in this field at all or, why we're excited about breprosidinib on slide 19, you know, I think it's important to think about where the disease biology fits in here.

And again, here, dual inhibition of TIK2 and JAK1, as a reminder, provides optimized, suppression of type 1 interferon, which is the key pathogenic cytokine in dermatomyositis.

I won't cover all of them here on the slide, just a couple of lines of evidence for that. One is that elevated levels of type 1 interferon are found in the relevant organ systems of, DM patients. The second is type 1 interferon gene signatures correlate with DM disease activity, go down, with successful therapy, and go up as disease worsens. Direct exposure of type 1 interferon to myotubes elicits a pathogenic response.

Including a partnership with Janssen and focus on Vince AI deep learning platform.

In generating novel molecular glues and Henry by functional protein integrators are collaboration with Proteus Vantiv blueprint to advance novel protein Degraders Act to address important areas of unmet need.

And then in early discovery collaboration would be I.

And we think we think there's more of this to come when we see a lot of enthusiasm for what we're doing on the discovery side with pharma partners, who are interested in using the kind of tools and modalities that we bet heavily on and I'll note that these three deals together have contingent milestone payments with well over $1 billion. In addition to.

Pension product royalties, and then not too much new to say here.

On slide 29.

Litigation surrounding gentlemen, its IP portfolio. This situation continues to develop.

Since we last provided a detailed update on it.

But I don't have as many of you may know on May six filed a partial motion to dismiss.

Our claims, which we responded to and we don't actually founded supply just a few days ago.

So the briefing on that motion to dismiss is now complete so we'll get the court decision when it comes and I'll, just say that rather than respond to the assumptions of our claims they filed the motion to dismiss.

And on identified portion, but not all of our lawsuit.

An apparent effort to ship responsibility for potential banded fundament to the U S government.

And then the only other sort of ongoing relevant litigation has been a QE pass an LNP company.

On March 18th filed an action against Gen event in our view just looking for a declaratory judgment basically looking for a statement that we are not infringing, but they are not infringing on our patents. So.

He told the court last week that we intend to dismiss our final motion to dismiss that lawsuit for lack of a natural controversy in soles.

We'll hear back from the court there as well.

We know that hitting both TIK2 and JAK1 seems to be required for maximal type 1 interferon, suppression.

And finally, in whole blood assays, we see evidence that brepro does exactly what you, think it should with greater type 1 interferon suppression than TIK2 inhibitors or JAK inhibitors.

So.

So on slide 20, in addition to type 1 interferon, dual inhibition of TIK2 and JAK1 also uniquely, suppress other DM-associated pathogenic cytokines, specifically interferon gamma, IL23, and IL12.

Wrapping up today with just a brief reminder of some of the financials of the period on slide 31.

And this signature is important.

I think.

We're pleased with where we are from a capital perspective.

And again, you can see in these whole blood assays that breprocytin has suppression that, compares favorably over TIK2 inhibitors and JAK inhibitors.

The three months ended 331 22, we had.

R&D expense of $135 million or adjusted non-GAAP of 118 million, we had minimal IP R&D of $2 million.

So on slide 21, here's a schematic of the program that is currently underway.

We had 139 million of G&A or adjusted non-GAAP of 77 million of G&A for a net loss of 291 or an adjusted net loss of 188.

And then we've also got metrics on the slide for the full year.

We've gotten regulatory alignment on the design. And we believe that if these data are robust, that this single phase 3, along with all the, other supporting evidence around the compound, should be sufficient or could be sufficient for approval.

And our balance sheet and most importantly remains really strong with $2 1 billion of cash and cash equivalents.

210 million of balance sheet debt witches.

Sort of a.

Our credit facility of $33 million and then the rest of that is effectively the present value of milestone payments.

Mostly at Derma that associated with the normal question and answer them here.

Yeah, and then finally on slide 32, I'll, just say we have.

So, you know, moving to lupus now, on slide 22, so this is obviously a pretty well-known, disease among the investor community.

A period of really exciting.

It continues to be one of the biggest autoimmune markets, obviously, and it continues to have, enormous unmet need.

New slow in inflammation and catalysts that we think are things. We're watching really closely that includes obviously continuing to follow closely the commercial launch of camera that includes thoughtful data.

Before it became an atopic dermatitis, a second potential blockbuster indication there in the first half.

That includes multiple readouts in additional indicate additional.

Program indication initiations and it'd be an advanced includes topline data coming next year for lupus and.

The classic hallmark is this sort of butterfly rash, but it can result in symptoms in basically, all major organ systems, and it has elevated mortality, and there's no question there's unmet need here.

It includes sort of upcoming Readouts are kind of AMT in Hema Vance so.

And all of that in addition to a potential outflow from our discovery apparatus and other things going on around the business. So.

It's widely recognized by patients, by physicians, and by regulators.

Benlista is an approved therapy. It was approved back in 2011, which was a huge achievement. It was the first drug approved in decades in the indication, but it's approved in spite, of a relatively modest effect of placebo-adjusted delta, somewhere between like 10 to 14%.

Anafrolimab was approved last year. It was really one positive study. The other major study outright failed and looked worse than placebo, but FDA kind of, looked at the totality of data. Again, there was significant unmet need, and the Phase II also looked supportive, and so, it was approved.

Adding period of execution for us an exciting period of upcoming catalysts and we're really pleased with that with where we are as a business.

So, clearly, lupus is not a solved issue.

I would like to turn the call back, to Matthew Glein for closing remarks.

With that I'll wrap up the formal presentation slide 31 is just a not just a non-GAAP should I start to slide 33 is just the non-GAAP disclosures and then slide 34 is a summary of our ownership and so I will I'll end there again I'll say, thank you for listening this morning, and I'm excited to take your questions. So I will turn it back to the operator to open the line.

I'd say a common conclusion is that almost nothing ever works, but actually, we think, that a lot of study failures have resulted from an attempt to improve upon what's already been successful rather than repeating what's worked, and that we can learn a lot from Benlista in particular, which was positive in all of its Phase III studies, despite some challenges on the efficacy side.

Great.

And so, yeah, I think it'd be fair to conclude we view this as a pretty high-risk proposition, and we have some humility in tackling it, but also there's some important lessons in what's likely to work, and we think we can design a study that maximizes chances for success.

Well, thank you, operator.

So, you know, on slide 23, for starters, we do have recent data for what happens if you, inhibit JAK1 or TIK2 in lupus in these patients, and the good news is there's signs of efficacy with the JAK1 inhibitor, as you saw in the Phase IIs and one of the Phase IIIs, Baricitinib, and then also, you know, with the recently announced Phase II of Ducravacitinib, which showed some noisy dose response, but, again, separation of each dose arm over a placebo that we think is a good supporter of drug efficacy, and, you know, there's obviously nuances in these study designs, and some of them we think made the data look more noisy than it really was.

And thank you to all who were listening today.

Thank you as a reminder to ask a question you will need to press star one on your telephone.

Appreciate all the really good questions.

Obviously an exciting combination of announcements for us.

Your question press the pound key please standby, while we compile the Q&A roster.

So yeah, looking forward to continuing, to provide updates over time.

Our first question comes from Dennis Yang with Jefferies. Your line is open.

So, you know, on slide 24, I won't belabor this point, but we did just want to show your, cross-study comparisons of BREPO versus those couple of drugs, and it's worth noting all of these diseases have very different biology from lupus, but just looking at the slide, you can see that BREPO is a really big gun, and it compares favorably to Ducra and Barry in each of these indications, so we think we have an opportunity to differentiate.

We looked at the biology ought to even play further in our favor, again, given the unique, signature of our drug.

Thank you for listening and have a good summer.

Like Tromatomyositis, lupus is known to be a type I interferon-driven disease, and BREPO, may provide sort of best-in-class suppression of type I interferon signaling in other cytokines implicated, such as IL-6, IL-12, and IL-23, and so our strategy here builds on evidence in the last 20 years that SLE has specific pathways that are relevant and also underscores that you can't go after just one axis for efficacy if you want robust efficacy.

Anafrolimab provides evidence that type I interferon inhibition provides activity in, SLE.

Hi, good morning, Thanks for taking my questions and congratulations on the.

We're the only oral drug to hit this axis as robustly, and then Barry provides evidence, that JAK1 inhibition provides modest activity in SLE, which includes IL-6 and interferon gamma.

The progress in our partnership with Pfizer.

Two questions for me one on Cryo Van can you just talk about the decision for Pfizer to the outlet.

Ducrava and Stellara provide evidence, that TIK2 inhibition or reduction in L12 and L23 also provides some activity in SLE, and we're the only drug to hit this full unique signature.

So, you know, on slide 25, here's the lupus study design.

It's a large global phase 2B study.

Okay.

It has all the design features you'd want for a pivotal.

I think there's clearly a lot of interest in the class.

These trial this trial a relatively early age have been enrolled already.

It's close to fully enrolled, actually, so that's an important piece of news.

Two fully enrolled so perhaps why do you think.

And we're using a 52-week endpoint, so we expect top-line data in the second half of next year, so quite soon.

Or in better hands.

Man person speiser, whose cost of capital is presumably lower.

And then my follow up question is on the camera and script volumes and whether you've had been tracking in line or better than your expectations.

Our.

And especially.

Especially on pricing if you can right size the street.

Would be really helpful. Thank you very much.

We'll be back out on a call like this in a couple of months.

This concludes today's conference call.

Yeah. Thanks, Dennis I appreciate the questions I appreciate your listening this morning before I take those in reverse order and I'll take the question first and then I'll give some thoughts on the on the private question. Then also estimate Youku work closely on that collaboration to chime in.

Thank you for participating.

You may now disconnect.

On V camera.

In terms of.

In terms of you know.

Script volumes.

We haven't said exactly what our expectations were.

I think what I'll say is we're pleased with the early demand. We're very pleased with the response from the docs that were out talking to it is very early days and so it's hard to it's hard to look at this and say we're ready to draw any conclusions. We are excited to see where this goes and we're looking forward to providing.

A more fulsome update and then no.

On gross to net I guess I'll just go back to what we said on the launch call, which is we are focused very hard at this stage in the game.

Get incredible high quality coverage.

Which includes the right formulary, which includes the Rebating strategy and so on.

I think until until that happens.

We're not providing specific guidance, but I would expect the gross.

Gross to net discounts just because of the way the.

The market works and then I expect that will normalize.

Once we have incredible coverage and what we've said is that is going to be about 12 to 18 months. So that's kind of what I would say on an.

The timbre.

And then it's important to note here, a feature of our collaboration with Pfizer is that Pfizer is sharing the expense of this study. It was already in flight when we launched PriVant, but in total, this ended up being a really highly capital-efficient bet for Roivant to make relative to running an entire lupus registration quality study from start to finish.

On the private advisor question. The first thing I'll say is I think you can see it in the partnership terms Pfizer remains excited about this program. They continue to invest in the lupus trial alongside us they own 25% of <unk>. They have economics went back to them and they have a large portfolio.

And obviously, we're excited to partner with Pfizer on it.

And then, you know, on the back of this, if successful, we'll just be one study away from approval in a quite large market.

So I'll wrap up on PriVant on slide 26, with just a recap of the partnerships. So Pfizer, as is sometimes the case, with our really important partners in Vance, owns an equity interest, a 25% equity interest in PriVant. PriVant develops the drug and owns commercial rights, to breprosytin in the U.S. and Japan.

Of drugs in this general sort of area of the world.

So you know I think even.

Even companies like Pfizer need to pick and choose and make strategic decisions and I think this was.

If I had to guess a tough one for them to quote unquote, let go when it has to do with the quality of our relationship that they thought it was in good hands with us and that it was going to generate.

Good value for them in this contract.

Sort of my high level answer might look I don't know if you would add anything to that in terms of how do you think Pfizer was thinking about it.

Yes, I think that's right. Thanks, Matt So I mean I think as.

And we also have similar rights to a mid-stage TIK2 inhibitor.

As Matt mentioned, obviously.

We view Pfizer is really the world leaders in.

In this specific.

Civic biology, and as you know.

A number of other programs, both marketed and late stage development in areas and I think we're looking at the data for PREPA has that evolved at all.

Largely been developing it in the.

Sort of a broader market indications and I think that they saw in our proposals.

A way to develop it.

You know a unique set of indications that again really play to the strengths of this specific molecule.

I think as you guys, probably all appreciate Pfizer, it's got a long history now of partnering assets with with.

This was a capital-efficient deal for us, so there was a nominal $10 million upfront, which actually included the purchase of inventory of drug in hand.

There's no regulatory milestones at all, in a single commercial milestone. There's a tiered sub-teams royalty, on net sales in our territories, and sales that are booked by Pfizer outside of our territories have a slightly lower but conceptually similar single milestone royalties flowing back to PriVant, back to us.

With new codes and they've done it with terrible with allergy spring works and.

So yeah, we are thrilled to unveil this program.

It's emblematic, we think, of our ability to work, with partners, often repeat partners, on high-impact therapies, with creative development strategies and with some capital efficiency.

We're really excited to.

To move forward with those <unk> been a great partnership.

Thanks, Dan.

And I'd say, obviously, a little bit of contrarianism, in moving into this area with what everyone else is sort of focusing on.

Thank you. Our next question comes from Yaron Werber with Cowen Your line is open.

Yes, hi, thanks for taking my questions and congrats also on the steel. So I also have a couple of questions on Brett BOE number one I guess I have three questions. One is the collaboration open ended in terms of indications or are you sort of restricted to lupus and dermatomyositis.

But we think it's gonna deliver a meaningful therapy, to patients in a range of diseases with high-end needs.

So we think this will be one of the anchor programs, in our portfolio in the years ahead, and looking forward to providing further updates as we continue to execute.

So I'm gonna go quickly through a couple of other updates.

That was the main new item for the period.

They're retaining.

Right.

Developed any other pick too.

Jack one independent of view for any indications, including these two.

And then finally, when we look at the prior data kind of two things jumped to mind, the you're right. The data you showed us the pretty good the topic dermatitis data was a bit weak and efficacy.

And then infection, there's obviously some infections, but nothing overly concerning on the safety.

To address those two as well thank you.

But I just wanted to give a couple of quick updates, on some other things going on around the portfolio, and then we'll wrap up with a brief financial update, and then open the line for questions.

Yes. Thanks.

So I'll have somebody to a couple of effects first of all the collaboration is definitely open ended.

So jumping ahead to slide 28.

Jumping ahead to slide 28, we've talked a little bit about this on earlier calls in the press release, but I'll just point out, at this point, we've done multiple strategic partnerships that validate the quality of our discovery pipeline and our discovery platforms, our discovery tooling, including a partnership with Janssen focused on Vance AI's deep learning platform, looking at generating novel molecular glues and heterobifunctional protein degraders, a collaboration with Proteavant and Blueprint to advance novel protein degraders to address important areas of unmet need, and then an early discovery collaboration with BI.

And we think there's more of this to come, when we see a lot of enthusiasm for what we're doing on the discovery side with former partners who are interested in using the kind of tools and modalities that we've bet heavily on.

With regard to indications and I would say that not only are we not limited to these two but given the quality of the compound I think you can imagine we are considering a whole range of things we might we might do with it so definitely not limited.

Maybe you can comment a little bit one specifics of what Pfizer might be limited to.

But in short I think you can imagine for a company like Pfizer with a portfolio like theirs.

Don't have.

<unk>.

They don't have a lot of.

Limitations on what they can do.

But maybe you can comment on the specifics there and then on the on the safety side, and then I'll hand over to Mike.

And I'll note that these three deals together, have contingent milestone payments of well over a billion dollars in addition to potential product royalties.

And then not too much new to say here on slide 29, but litigation surrounding Genevans IP portfolio, this situation continues to develop. Since we last provided a detailed update on it, Moderna, as I think many of you may know, on May 6th filed a partial motion to dismiss our claims, which we responded to, and Moderna actually filed its reply just a few days ago.

So the briefing on that motion to dismiss is now complete, so we'll get the court decision when it comes.

And I'll just say that rather than respond, to the substance of our claims, they filed a motion to dismiss an unidentified portion, but not all of our lawsuit, in an apparent effort to shift responsibility for potential patent infringement to the U.S. government.

And then we've also got metrics on the slide for the full year.

And then the only other sort of ongoing relevant litigation, is that a QATAS, an LNP company on March 18th filed an action against Genevans and argued it's looking for a declaratory judgment, basically looking for a statement that they are not infringing on our patents.

With any of these topics.

And our balance sheet, most importantly, remains really strong with $2.1 billion of cash and, cash equivalents and $210 million of balance sheet debt, which is a sort of a credit facility of $33 million.

So we told the court last week, that we intend to dismiss that, or file a motion to dismiss that lawsuit for lack of an actual controversy.

And then the rest of that is effectively the present value of milestone payments, mostly at, DermaVant associated with the NovaQuest financing there.

And so we'll hear back from the court there as well.

I'd say.

So, wrapping up today with just a brief reminder of some of the financials of the period on, slide 31, you know, I think we're pleased with where we are from a capital perspective.

Broadly first of all remember this compound has been developed extensively it's been exposed in.

In the three months ended 3-31-22, we had R&D expense of $135 million or adjusted non-GAAP, of $118 million. We had minimal IP R&D of $2 million.

We had $139 million of G&A or adjusted non-GAAP of $77 million of G&A for a net loss of $291, or an adjusted net loss of $188.

Yeah.

And then, you know, finally on slide 32, I'll just say we have a period of really exciting news flow, and information and catalysts that we think are things we're watching really closely.

Over 1000 subjects and patients.

In that we've observed rates of.

Let's say Jack less specific adverse events that are in line with those observed in other programs from a tolerability standpoint has generally been well tolerated I agree with you things like infection numbers or not.

Particularly problematic.

I think we feel we feel like the safety profile is.

As consistent as favorable for the development strategy, we have in mind and it's something we're mindful of and I think frankly, the focus on Tolerability for JAK inhibitors is part of what has given us the opportunity to do something.

Unique and different here.

So what you've got on with anything you'd add on any of those points in specific if you want to comment on the <unk> data or on that or on any limitations that Pfizer has.

Yeah.

Nothing nothing really to add here I mean I think.

As one might expect and I think that we were committed to.

These programs is our sort of expression of our interest in this particular biology I think as Matt noted, we don't have limitations on what we can pursue.

And I think.

As one might expect I think I think sort of some of these core indications that we've highlighted today.

It was important to us.

To kind of have prior that the way in which Pfizer is expressing interest in these indications as well.

Just one comment on the EBITDA I think you are.

Youre, referring to the published data they published data.

This data was in topical breakfast hitting them.

Our lead compound here is the oral formulation, we have rights to the topical as well sort of deciding what to do with it obviously, it's an area. We have a fair amount of interest in what I would say.

The activity data that we have that's most relevant to us is the data from the oil program.

Thank you so much. Thank you. Our next question comes from Robyn Karnofsky.

Securities Your line is open.

Hi, This is Alex on for Robyn.

Yeah, Congrats on the partnership.

Quick question on our events and once you guys could provide a little more color on what factors led to the wind down of the sickle cell program.

And also how should we think about the approach to future resource allocation for existing Vance versus interest in additional.

Initiation of subsidiaries.

Yeah, Thanks look at them.

It's always a tough decision to wind down the program that you're you're potentially excited about.

And so you know there were a lot of factors I would say.

Chief among them from my perspective.

Other than a broad desire to be careful about how we're allocating resources in the current environment.

Is the clinical bar for sure to therapy in sickle cell disease really is curative.

And I think as you look at the development of that field with the other programs.

We felt like that was really high.

And we got nervous that we might not quite achieved the squeaky clean clinical par there.

Look these are.

These are patients with few options, but actually the pipeline across biotech is pretty broad.

It's obviously been a little bit of a challenge area.

But we still feel we still feel good about the high likelihood that curative therapies and genetic medicine are going to make it the sickle cell patients.

We're obviously disappointed to bow out but.

But we're incredibly appreciative of the patients that have worked with us and obviously the investigators that have worked with us as well as our whole team.

It's something that we took a swing that so yes, it's tough decision.

I think what it enables for us.

Is to continue to be broad minded in our portfolio we have to make.

Decisions like this.

And we have to make them quickly and decisively.

In order to be able to do things like this partnership with Pfizer Opportunistically and we think the current capital markets are going to give us even more opportunities of that kind and so when we have when.

When we have the ability to make these decisions. It's just something we have to we have to do quickly. So so it's something that it's always disappointing as I said, but it's just the kind of decision we have to.

We are making.

Gotcha, and you mentioned that you've got some initial physician feedback on the printer offer to printer off label can you elaborate on that a little bit.

Yeah, I would say.

Just.

Generally as we've been out to docs.

As our field forces went out to doctors are dominant leadership team has been sort of out talking to the medical community.

A lot of excitement and enthusiasm for the label. We obviously, we're excited about it when we first thought but what you heard on the call. A few weeks ago was really our enduring that management teams.

First impressions of what seemed to be a very clean label and I think as you get out there just all the things that we would have hoped are resonating.

Are resonating with prescribers.

And so yeah, we're really excited to watch the.

To watch the progress there as that team gets out and does and does what it does best.

Great. Thanks, so much.

Thank you. Our next question comes from <unk> Chen with Cantor Your line is open.

Hi, Thank you for taking my questions here. So I wanted to ask you a few things first one if you could talk about the market opportunity for.

<unk> and myasthenia gravis, and where do you think your chocolate fit into the treatment landscape. If it's approved second question I had for you is how do you think about to painter off or if he tomo and the potential opportunities psoriasis and atopic dermatitis. What gives you confidence in the positive data are positive data readout in 2000.

<unk> 23 in atopic dermatitis, and then can you talk about the pushes and pulls on your cash runway.

Yeah. Thank you I will.

I'll take those questions in some order here.

That includes, obviously, continuing to follow closely the commercial launch of Vitama.

I'll start with the camera question because Peter off question.

We're looking forward to that readout.

We like the biology of HR modulation very much it's something you've heard us talk a fair amount about.

And we think it's important to inflammatory skin disease generally and then I would say the thing that gives us most confidence about our readout in Nash.

That includes topical data for Vitama and atypical dermatitis, a second potential blockbuster, indication there in the first half.

That includes multiple readouts and additional program initiations at ImmuneVant.

It includes top-line data coming next year for lupus.

It includes sort of upcoming readouts at Kynavant and ImmuneVant, and all that in addition to, potential output from our discovery apparatus and other things going on around the business.

In the first half of next year is that we have.

Compelling phase II data.

In atopic dermatitis that is guided.

Our development strategy and we feel like we've designed the trial.

Maximize the opportunity there.

So an exciting period of execution for us, an exciting period of upcoming catalysts.

And in terms of the opportunity look we think it's really really big and we think we have an opportunity for a blockbuster program.

And we're really pleased with where we are as a business.

And with that, I'll wrap up the formal presentation.

In both indications.

Or in each indication.

And we're hopeful that our data.

Next year is going to support it.

So.

But total Nab.

Yes.

M G M.

We've talked a bit about this before and I think the management team will continue to talk about it as well.

We view that market is.

Large and interesting we view the evidence for SCRA modulation being effective.

Is obviously robust at this point across multiple programs and we think that the specific trial design that would be an event is employing there.

With induction and maintenance and rescue therapy, and with all of the flexibility that comes from.

From the subcutaneous administration from the trial design, allowing doctors to move patients between doses.

At various times and randomize them across different doses is going to give us a relief.

Differentiated profile relative to any of the other.

FTR engine development.

And obviously.

Because the programs, including the label on Ziff Guard is well known and frankly doesn't have the same level of flexibility. So.

We feel a big opportunities.

<unk> for a differentiated program.

Yes.

And we think we've got a development strategy and frankly.

Maybe this is another important point.

We have the ability to suppress agg.

We think deeper than roughly we believe any of the other anti <unk> antibodies in development will do and that's a combination of the actual molecule and the way we're developing it and look we think that has the potential to drive maximum overall efficacy. In addition to the flexibility that you can paradigm. So we think we have a chance to.

To win competitively on multiple axes, there and we think yes youre in classes in a matter of timing for those patients.

And then finally on cash runway.

I'll reiterate.

We have over two years of runway, we try and generally run our business to be confident in over two years of runway visibility.

It's easy for us to do that because we have a very broad portfolio with lots of pushes bowls and we have over two years of runway assuming everything succeeds we move a whole bunch of discovery programs forward. So there's a lot of flexibility.

As things evolve to modulate that we just feel really lucky to be in the capital position.

We're in.

We think.

You know in terms of Poles and sort of the obvious things.

The time of launch late stage clinical programs those are all <unk>.

Slide 31 is just a non-GAAP.

Expensive, but in terms of pushes and I mentioned this at the beginning of the call and I think it's really important point, we have a lot of flexibility for sources of capital that go beyond the capital markets. Obviously, we're watching the capital markets closely but we haven't.

Sorry, slide 33 is just the non-GAAP disclosures, and slide 34 is a summary of our Vant ownership.

And so I will end there.

A number of other opportunities partnership.

Again, I'll say thank you for listening this morning, and I'm excited to take your questions.

Obviously gen event monetization of stakes.

A number of tools to allow us to modulate our cash balance even outside of the capital markets. So we feel as I said very privilege, both about our business model.

And about our.

And about <unk>.

And by our cash balance capability there. So I appreciate the question. It's a good question to the current market for sure.

Thank you.

Thank you our next question will come.

Sure.

So I will turn it back to the operator to open the line.

<unk> with Citi. Your line is open.

Thank you.

Hey, guys. Thanks for taking my question.

As a reminder to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.

Please stand by while we compile the Q&A roster.

Is that would prevent a partnership with Pfizer I believe there were actually two assets as part of that deal could you maybe talk a little bit about the second asset and kind of thoughts on that.

And then on the.

Updates on the LNP patent litigation.

Is there any update that you can give in terms of timing for when we could hear.

The decision on the motion to dismiss will be great. Thanks.

Our first question comes from Dennis Ding with Jeffries.

Sure.

So the other asset in the Pfizer partnership was a selective to do with its own unique signature.

We wanted to use this call to focus on.

On <unk> given the fact, it's a lead molecule and is already in.

Registrational studies.

We don't have plans to share right now for <unk>.

Looks at <unk>, which is that which is that selective <unk>.

We're most focused on combination.

Oh, I'm, sorry, and then on the on the IP question that you asked I don't think we have a specific comment on the courts timeline for response, there I think it's ultimately up to the court I don't think Theres a prescribed timeline for it.

So they get they have discretion to decide when they want to so.

We're watching for it in the coming months is what I would say.

Awesome. Thank you.

Thank you. Thank you. Our next question comes from David Risinger with SBB Securities. Your line is open.

Your line is open.

Hi.

Yes, thanks, very much and I wanted to add my congrats on the submarine Pfizer transaction.

Good morning.

Thanks for taking the questions, and congratulations on the progress and the partnership with Pfizer.

So my questions are as follows first could you talk about the expected payer access ramp or to pin a ralph.

Two questions for me.

One on PrioVant.

And then how.

We as investors should think about net sales in coming quarters since it's going to take a while for payer access to actually take hold.

Then second with respect to court action on the LNP litigation.

Had could you just talk about potential timing and how we should think about developments to watch.

And third.

I don't know if Richard is on the call, but would be helpful to understand how we should be thinking about.

Cash flow in the upcoming fiscal year.

Specifically operating cash flow or operating cash burn I mean, thank you.

Yeah. Thanks, Thanks, Dave those are those are all great questions I appreciate it.

On to Peter off.

Sure payer ramp I think we've as we've come into a little bit response, some of the other questions here.

Said, our main focus is on high quality coverage.

What that means is we're prepared to do the work to get the covered claims through to get payers to pay attention to the program and that's what we're doing now. So we are most focused on as I think we've said a few times script script volume during this period of initial launching.

Expect.

Expect that to last for a little while here and then what we said is that we expect to have that coverage online kind of in the 12 to 18 months timeline and that's when we would expect gross to net test to ramp up and normalize and I would say, we will be prepared to provide better specific guidance on what we think normal gross to net will look like for us.

Once we have a little more visibility into those into those contracts and so on so I think.

Stay tuned on that topic.

Then.

On the Olympia litigation, you I think a similar answer.

Yes.

To the prior question here.

The district Court has has discretion.

On when they respond to sort of the next major action errors. The district Court's response to tumor <unk> motion to dismiss them visually or has.

Some discretion there, but in general they tend to respond within months.

That's something to.

Specifically watch out for.

We think the civitas acute situations.

Less direct interest, but that's obviously also.

Ongoing and we'll get some feedback from the court there and then.

Beyond that I don't know of a lot to comment on right now or on any other.

Awesome movement, there, but those are the things where.

We're watching most closely.

And then Richard is on it so I can hand, it over to him for any additional comments on operating cash flow, but I think.

While we haven't given that.

Specific sort of cash flow statement metric guidance I think you can you can look at where things have been and you can look at the runway guidance that we're giving overall.

And back in a little bit to kind of what we think.

Well, we think things are going to look like from an operating cash flow perspective, Richard I'd know, if there's anything you would add to that.

Okay. Thanks for the question look we haven't provided guidance for the year, specifically, but I'm very pleased with.

The required patient we've done.

At quarter and as we think about the portfolio I think we haven't really high bar here as we moving forward, we will have data emerging from us from competitors and we'll put the same laser focused lens on taking additional programs forward as data emerges from from our programs and externally.

And <unk>.

Certainly as we ramp up heavy camera launch.

And the 80 days. It comes through you can think about some of the additional spend pro launch down the line and then as we said from Eaton Vance.

Additional phase III trials that will be coming through.

That youll see kind of.

By the end of the year.

And some of the other savings that we've talked about.

Our confidence in Atlanta, two plus years.

Our runway but.

We're not providing one year guidance.

Thank you very much.

Thanks, Dave.

Our next question comes from.

Your line is open.

Hi, good morning, Thanks for taking my questions.

Can you just talk about the decision for Pfizer to outlicense these assets?

I think there's clearly a lot of interest in the class, and these trials seem relatively, late stage, having enrolled already, or close to fully enrolled.

Maybe to start I know you highlighted that you've gotten some positive feedback on for Tom in the early days I'm just curious.

So perhaps why do you think these assets are in better hands with VioVant versus Pfizer, whose cost of capital is presumably lower?

When we think about the sort of selling points that you had for <unk>.

And then my follow-up question is on the TAMA and script volumes, and, you know, whether, these have been tracking in line or better than your expectations thus far.

<unk> dependent off overtime or is there anything in particular that is resonating with physicians are sort of really standing out to them.

In the early conversations.

Yes, so yeah in the last couple of weeks, we've execute on speaker training, we've been out to sort of top thought leaders on.

In psoriasis I think in general what are we getting people. We're excited about the little bit of data. Obviously, that's something we expected I'd say the cosmetic elegance of the frame itself, but potentially that people can tell immediately unused that we've gotten good feedback on that and on tolerability.

Right out of the gate.

Yes, mostly confirms the survey data that we've previously shared.

And we're excited to see the patients want to use it again and then I'd say early indications from the field onset of action its benefit efficacy benefit and I think.

These are the kinds of things that you would expect to hear on the early launch, but we're pretty.

Pretty encouraged by it.

Okay, Great and then just as a follow up and I might have missed it could.

Could you just maybe talk a little bit about the origins of the depot transaction with Pfizer was this an asset that you would identified and reached out to them or did they reach out to you to discuss it.

I will hand over the origin story too Mike.

Sure.

Yeah, I mean, I think that you should assume that look I think we.

We have a great working with Pfizer we have.

Alright, so if other pharma companies as well.

It's almost more of an ongoing dialogue than an.

On outreach or specific outreach in either direction, but this is obviously.

A striking I think really unique.

Drug that I think we have seen their data evolve and emerge.

For a period of time and.

And we're excited that we're able to kind of have a win win collaboration and we're just getting started.

And I guess, especially on pricing, if you can right-size the street on course net, that, would be really helpful.

And I guess, maybe my final question on that but when do you think about sort of prioritization.

Thank you very much.

Thanks, Dennis.

Obviously, you're starting.

And <unk> and lupus I'm just curious how are you thinking about.

I appreciate the questions.

Some of the bigger indications that we already have some proof of concept data on or sort of some early clinical data are those worth pursuing or something that you think about down the road.

I appreciate your listening this morning.

Yeah. Thanks.

I'll probably take those in reverse order, and I'll take the VTAMA question first, and, then I'll give some thoughts on the private question and also ask Mayukh who worked closely on that collaboration to chime in.

It's a good question and obviously.

The data that we have or are highly compelling.

Across a range of indications I think they highlight.

Just how strong our molecule it is I think right.

On VTAMA, in terms of script volumes, we haven't said exactly what our expectations were. I think what I'll say is we're pleased with the early demand.

Right now we're focused on the development strategy that we've laid out here not just in these indications, but frankly in other indications that Ryan I think there are many.

We're very pleased with the response from the docs that we're out talking to.

It is very early days, and so it's hard to look at this and say that we're ready to draw, any conclusions.

And so I would say that's our.

Our initial focus and I think you can expect a sort of continuing to pursue that line that said we're watching it closely.

Closely and.

Looking forward to continuing to lie uptake.

As we yes.

As we get going we think we can.

We can generate right.

That's perfect.

And I guess it Matt is bothering you should we think about this as sort of an asset similar to what we've seen with <unk> in terms of just the rollout of new indications or do you think that these two are going to be the ones that we should focus on for certain amount of time.

I think you should focus on these two firstly you should expect us to continue to announce some further opportunities as they crystallize obviously, it's a competitive area so like Taco Mab.

We are excited to see where this goes, and we're looking forward to providing a more, fulsome update.

And then on Gross to Net, I guess I'll just go back to what we said on the launch call, which is we are focused very hard at this stage in the game on getting credible, high-quality coverage, which includes the right formulary, which includes the right rebating strategy, and so on.

We're focused on making our decisions excuse me I'm talking about them in the right order, but I think you should expect us to.

I think until that happens, we're not providing specific guidance, but I would expect deep, Gross to Net discounts just because of the way the market works, and then I expect that will normalize once we have credible coverage, and what we've said is that's going to be about 12 to 18 months, so that's kind of what I would say on VTAMA.

On the Pryvan-Pfizer question, the first thing I'll say is I think you can see it in the, partnership terms.

Pfizer remains excited about this program.

To continue to.

To page engineering look we think that.

They continue to invest in the lupus trial alongside us.

They own 25% of Pryvan.

This should work in indications a variety of indications of high morbidity and mortality with few approved airports therapies and we're looking at areas, where there is highly inflammatory path of Biology's, where specifically dual inhibition to tick to inject JAK, one and we expect to provide greater efficacy than either alone and we think theres multiple to choose from in addition to the two that we've mentioned today.

Thank you.

Thank you. Our next question comes from Ron Jenkins with Goldman Sachs. Your line is open.

They have economics flowing back to them, and they have a large portfolio of drugs in, this general sort of area of the world, and so I think even companies like Pfizer need to pick and choose and make strategic decisions, and I think this was, if I had to guess, a tough one for them to, quote-unquote, let go, and it has to do with the quality of our relationship that they thought it was in good hands with us and that it was going to generate good value for them in this construct, so that's sort of my high-level answer.

Mayuk, I don't know if you would add anything to that in terms of how you think Pfizer was, thinking about it.

Ian Good morning, you highlighted at the end there that you have this increasingly broad and rheology.

Yeah, I think that's right.

Thanks, Matt.

So, I mean, I think, as Matt mentioned, obviously, you know, we view Pfizer as really the world, leaders in, you know, in this specific biology and has, you know, a number of other programs both marketed in late-stage development in these areas, and I think, you know, we're looking at, you know, the data for BREPA that evolves and largely been developing it in, you know, the sort of the broader market indications, and I think that they saw in our proposal sort of a way to develop it in, you know, a unique set of indications that, again, really play to the strengths of this specific molecule.

I think, as you guys probably all appreciate, you know, Pfizer's got a long history now, of partnering assets with NUCOs, they've done it with CeraVel, with Allogene, with SpringWorks, and, you know, we're really excited to move forward with this.

Of course, these aircrafts to prevent certain carriers could you talk about any potential synergies across the southern bad weather.

Whether that's an area we should expect you to continue.

It's been a great partnership.

And the portfolio.

Thanks.

Please, Dennis.

Yes.

Thank you.

It's a good question I appreciate I appreciate your listening.

Our next question comes from Yaron Warber with Cowen.

I would say couple of things first of all.

Your line is open.

We continue to.

<unk> did not want to pigeonhole ourselves specific therapeutic areas I think you'll continue to see us taking opportunities more broadly than just immunology there are obvious benefits.

To having.

Yes.

Our concentration or some elevated expertise in an area I think we see it in our diligence we see it in our track record in People's understanding of our ability to execute these kind of deals in these kinds of programs.

Ultimately.

If there are overlaps in commercial footprint.

The ability to do interesting things through to that family and working with management teams to maximize sort of synergistic value but.

We also have the flexibility to treat the programs are separate and so I would say, we get benefit from talent mobility.

We get benefit from leadership, we could benefit from sharing ideas across the family and I think down the line as we get closer to commercial and some of these programs. We have the ability to think creatively about collaborations.

The flexibility to.

Do what makes sense.

Across the family.

One of the things in particular, which is talent mobility, we talked about.

You're prioritizing some programs today.

One of the great things about the model is that we have the ability to take that.

Did you offer top talent from.

From from Vance from programs that we do prioritize opportunities.

Other places around the organization and that's something that has always been core to our model and it's something that a concentration.

But given therapeutic area makes it even easier and so I think it's.

Something we're excited to have.

That's helpful.

Thank you.

Thank you and I'm currently showing no questions at this time I would like to turn the call back to Matthew Klein for closing remarks.

Hi.

Great well. Thank you operator, and thank you. Thank you to all who are listening today. Appreciate all the really good questions. Obviously, an exciting combination of announcements for us.

Number one, I guess I have three questions.

Thanks for taking my questions and congrats also on this deal.

One, is the collaboration open-ended in terms of indications, or are you sort of restricted, to lupus and dermatomyositis?

So, I also have a couple of questions on BREPA.

And finally, when we look at the prior data, kind of two things jump to mind.

You're right, the data you showed us looked pretty good.

The topic dermatitis data was a bit weak on efficacy, and then infection, there's obviously, some infections, but nothing overly concerning on the safety to address those two as well.

One comment on the AD data.

Thank you.

I think you're referring to the published data, they published some data.

Yeah, thanks.

The published data was in topical brevositinib, so our lead compound here is the oral formulation.

So, I'll hand it to Mayukh to cover a couple of these things.

We have rights to the topical as well, we're sort of deciding what to do with it.

First of all, the collaboration is definitely open-ended with regard to indications, and, I would say not only are we not limited to these two, but given the quality of the compound, I think you can imagine we are considering a whole range of things we might do with it, so definitely not limited.

Our next question comes from Robyn Karnauskas with TruSecurity.

So, yes looking forward to continuing to provide updates.

Obviously, it's an area we have a fair amount of interest in, but I would say the activity, data that we have that's most relevant to us is the data from the oral program.

Mayukh can comment a little bit more on the specifics of what Pfizer might be limited, to, but in short, I think you can imagine for a company like Pfizer with a portfolio like theirs, they don't have a lot of limitations on what they can do, but Mayukh can comment on the specifics there.

Your line is open.

Thank you.

Thank you so much.

And then on the safety side, and then I'll hand it over to Mayukh to comment on any of, these topics, you know, I'd say broadly, first of all, remember, this compound has been developed extensively. It's been exposed to over 1,000 subjects and patients, and, you know, we've observed rates, of, let's say, JAKLA-specific adverse events that are in line with those observed in other programs. From a tolerability standpoint, it's generally been well-tolerated.

Hi.

Our next question comes from Lisa.

Thank you.

I agree with you that things like infection numbers are not particularly problematic. You know, I think we feel like the safety profile is consistent, is favorable for the, development strategy we have in mind, and it's something we're mindful of.

This is Alex.

This is Louise Chen with Panther.

Overtime.

I think, frankly, the focus on tolerability for JAK inhibitors is part of what has given, us the opportunity to do something unique and different here.

I'm for Robyn.

Thank you.

Your line is open.

So, Mayukh, I don't know if there's anything you'd add on any of those points in specific, if you want to comment on the AD data or on any limitations that Pfizer has.

Yeah, congrats on the partnership.

Thank you for listening in.

Yeah, thank you.

Hi.

Yeah, nothing really to add here.

Quick question on our events and wanted to know if you could provide a little more color, on what factors led to the wind down of the Sickle Cell Program and also how should we think about the approach to future resource allocation for existing events versus interest in additional initiation of subsidaries?

I'll take those questions in some order here.

Thank you for taking my questions here.

I mean, I think, as one might expect, I mean, I think that we're committed to, you know, to these programs as our sort of, you know, expression of our interest in this particular biology.

Yeah, thanks.

Have a good summer when we back out on a call like this in a couple of months.

I'll start with the vitama question, the tapenerof question.

So I wanted to ask you a few things.

I think, as Matt noted, we don't have limitations in what we can pursue, and I think, as one, might expect, I think sort of some of these core indications that we've highlighted today, you know, it was important to us, you know, to kind of have prior event be the way in which Pfizer is expressing interest in these indications as well.

Look, it's always a tough decision to wind down a program that you're potentially excited, about. And so, you know, there were a lot of factors.

You know, we're looking forward to that readout.

First one, if you could talk about the market opportunity for batoclimab and myasthenia gravis, and where you think your drug would fit into the treatment landscape if it's approved.

I would say, you know, chief among them from my perspective, other than a broad desire, to be careful about how we're allocating resources in the current environment, is the clinical bar for curative therapy in sickle cell disease really is curative.

Our next question comes from Nina Betrisogar with Citi.

We like the biology of AHR modulation very much.

The second question I have for you is how do you think about tapenerof or vitama, and the potential opportunities to rhizos and in atopic dermatitis?

And I think as you look at the development of that field with the other programs, we, felt like that bar was really high. And we got nervous that we might not quite achieve the squeaky clean clinical bar there.

It's something you've heard us talk a fair amount about.

What gives you confidence in the positive data or positive data readout in 2023 in atopic dermatitis?

And, you know, look, these are patients with few options, but actually the pipeline across, biotech is pretty broad.

And we think it's important to inflammatory skin disease generally.

And then can you talk about the pushes and pulls on your cash runway?

It's obviously been a little bit of a challenge area, but we still feel good about the high, likelihood that curative therapies and genetic medicine are going to make it to sickle cell patients.

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

And then I would say the thing that gives us most confidence about our readout in the first half of next year, is that we have compelling phase two data in atopic dermatitis that has guided our development strategy. And we feel like we've designed the trial to maximize the opportunity there.

We're obviously disappointed to bow out, but we're incredibly appreciative of the patients, that have worked with us and obviously the investigators that have worked with us, as well as our whole team.

And in terms of the opportunity, look, we think it's really, really big. We think we have an opportunity for a blockbuster program in both indications or in each indication.

And it's something that, you know, we took a swing at.

And we're hopeful that our data next year is going to support it.

So, yes, it's a tough decision.

So, you know, on batoclimab in MG, you know, we've talked a bit about this before, and I think the Immunevent team will continue to talk about it as well.

I think what it enables for us is to continue to be broad minded in our portfolio.

We view that market as large and interesting.

We have to make decisions like this, and we have to make them quickly and decisively in, order to be able to do things like this partnership with Pfizer opportunistically, and we think the current capital markets are going to give us even more opportunities of that kind.

We view the evidence for FCRN modulation being effective is obviously robust at this point across multiple programs.

And so, you know, when we have the ability to make these decisions, it's just something, we have to do quickly.

And we think that the specific trial design that Immunevent is employing there with induction and maintenance and rescue therapy, and with all the flexibility that comes from the subcutaneous administration, from the trial design allowing docs to move patients between doses at various times and randomizing across different doses is going to give us a really differentiated profile relative to any of the other FCRNs in development.

It's always disappointing, as I said, but it's just the kind of decision we have to, make.

[music].

And obviously the details of those programs, including the label on Vivgard, is well known, and frankly doesn't have the same level of flexibility.

Gotcha.

So, you know, I think we feel big opportunities in MG for a differentiated program.

And, yeah, you mentioned that you got some initial physician feedback on the Tupinarov, label.

And we think we've got a development strategy.

Can you elaborate on that a little bit?

And frankly, maybe this is another important point, we have the ability to suppress IgG.

Yeah, I would say just generally, as we've been out to docs, as our field force has been, out to docs, as our leadership team has been sort of out talking to the medical community, I think there's just a lot of excitement and enthusiasm for the label.

We think deeper than roughly we believe any of the other anti-FCRN antibodies in development will do.

We obviously were excited about it when we first saw it, but what you heard on the call, a few weeks ago was really our management team's first impressions of what seemed to be a very clean label, and I think as you get out there, all the things that we would have hoped are resonating are resonating with prescribers, and so, yeah, we're really excited to watch the progress there as that team gets out and does what it does best.

That's a combination of the actual molecule and the way we're developing it.

Great.

So we think that has the potential to drive maximum overall efficacy in addition to the flexibility of the treatment paradigm.

Thanks so much.

So we think we have a chance to win competitively on multiple axes there.

And we think the FCRN class is going to matter a ton for those patients.

And then finally, on cash runway, you know, I'll reiterate, we have over two years of runway.

We try and generally run our business to be confident in over two years of runway visibility.

It's easy for us to do that because we have a very broad portfolio with lots of push and pulls.

And we have over two years of runway, assuming everything succeeds, we move a whole bunch of discovery programs forward.

So there's a lot of flexibility as things evolve to modulate that.

We just feel really lucky to be in the capital position that we're in.

You know, we think, you know, in terms of pulls, it's sort of the obvious thing.

We kind of launch late case clinical development programs. Those are all expensive.

But in terms of pushes, and I mentioned this at the beginning of the call, and I think it's a really important point, we have a lot of flexibility for sources of capital that go beyond the capital markets.

Obviously, we're watching the capital markets closely, but we have a number of other opportunities.

Obviously, GenEvent, monetization of stakes, just a number of tools to allow us to modulate our cash balance, even outside of the capital markets.

So we feel, as I said, very privileged both about our business model and about our cash balance capability there.

So, yeah, appreciate the question.

It's a good question in the current market for sure.

Thank you.

Yeah.