Q1 2023 Roivant Sciences Ltd Earnings Call

August 15, 2022

Okay.

Good day, and thank you for standing by welcome to the.

Operator: Good day, and thank you for standing by.

Operator: Welcome to the Roivant 1Q 2022 earnings call.

<unk> 2022 earnings call at this time, all participants are in a listen only mode.

Operator: At this time, all participants are in a listen-only mode.

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

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

Operator: To ask a question during the session, you will need to press star 11 on your telephone. Please be advised that today's conference is being recorded.

To ask a question during the session you will need to press star one one on your telephone.

Please be advised that today's conference is being recorded.

Operator: I would now like to hand the conference over to your speaker today, Paul Davis, Head of Communication.

I would now like to hand, the conference over to your speaker today.

Paul Davis head of communication. Please go ahead.

Good morning, and thank you for joining today's call to discuss <unk> financial results for the quarter ended June 32022.

Operator: Please go ahead.

Paul Davis: Good morning, and thank you for joining today's call to discuss Roivant's financial results, for the quarter ended June 30, 2022.

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

Paul Davis Paddock indications right now presenting today, we have Matt Klein, our Chief Executive Officer.

Paul Davis: Presenting today, we have Matt Gline, our Chief Executive Officer.

Paul Davis: For those dialing in by a conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com.

For those dialing in by a conference call you can find the slides are being presented today as well as the press release announcing these updates on our IR website at Www Dot Investor Dot <unk> Dot Com will also be providing the slide numbers as we presented to help them along.

Paul Davis: We'll also be providing the current slide numbers we present to help you follow along.

Paul Davis: I would like to remind you that we will be 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.

I'd like to remind you that we will make 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.

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

Strongly encourage you to review the information about the SEC, including the earnings release and Form 10-Q filed this morning for more information regarding these forward looking statements and related risks and uncertainties.

Paul Davis: We'll begin with Matt Gline.

I will begin with my final review key business updates across the advanced and provide the financial update we will end the call with a Q&A session with that I'll turn it over to Matt.

Paul Davis: We'll review key business updates across Roivant's advance and provide a financial update.

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

Thank you Paul and good morning, everybody and thank you for joining our first quarter earnings call. I think you all will be a little bit shorter than usual because we last got together.

Paul Davis: And with that, I'll turn it over to Matt.

Matt Gline: Thank you, Paul, and good morning, everybody, and thank you for joining our first quarter earnings call.

Matt Gline: Today's call will be a little bit shorter than usual, because we last got together, about six weeks ago when we presented our year-end results.

Six weeks ago, when we presented our year end results.

Matt Gline: So, I'll begin on page four, and I'll take you through some of the key highlights, of the business today, and then we'll make some time for Q&A.

So I'll begin on page four and I'll take you through some of the key highlights of the business today and then we'll make some time for Q&A.

Matt Gline: So, as a reminder, we're excited about where we are at the end of our first quarter this year, with obviously a number of important attributes, including the ongoing commercial launch of Vitama, which we will spend a little bit of time on this morning.

So as a reminder of where does that we're excited about where we are at the end of our first quarter of this year.

With obviously, a number of important attributes, including the ongoing commercial launch of <unk>, which we will spend a little bit of time on this morning.

Matt Gline: That is backed by a broad clinical-stage pipeline, including multiple pivotal, and registrational studies currently ongoing.

That is backed by a broad clinical stage pipeline, including multiple.

Pivotal Registrational studies currently ongoing.

Matt Gline: Our CHIP-to-clinic discovery program, including our proprietary Quasar platform, that we are using to bolster that pipeline at the discovery stage.

Our tip the clinic discovery program, including our proprietary <unk> platform.

We are using to bolster that pipeline at.

The discovery stage.

Matt Gline: A number of sources of asymmetric potential upside, including our Geneva IP portfolio, and all of that supported by what continues to be a strong capital position with $2 billion in cash-and-cash equivalents and restricted cash, which enables us to finance and develop all of our programs across our pipeline.

<unk> of sources of asymmetric potential upside including.

Our IP portfolio.

And all of that supported by what continues to be a strong capital position with $2 billion in cash and cash equivalents and restricted cash.

Which enables us to finance and develop all of our all of our programs across our pipeline.

Matt Gline: So, I'll start on page five with a brief update on the Vitama launch, and I'll say, first of all, I'm incredibly pleased with the very early information here. Obviously, as we've said on a number of occasions, we are principally tracking prescriptions at this time, and we feel script volume has been robust in the early days of the launch. Obviously, it is still the early days. We're only a couple months in, but we feel the script volume and the early feedback, from providers has been very, very strong. There are a few key updates in recent weeks around this launch.

So I'll start on page five with a brief update on the <unk> launch and I'll say first of all I'm incredibly pleased with with the <unk>.

Every early that information here.

Obviously as we've said a number of occasions, we are principally tracking prescriptions at this time.

We feel script volume has been robust in the early days of the launch obviously it is still the early days, we're only a couple of months and but we feel the script volume and the early feedback from providers has been.

Very very strong there are a few key updates.

In recent weeks around this launch.

Matt Gline: The first is that our LTE data, our long-term extension study data, has been published in JAD, and that highlights the 130-day remittive effect off therapy for patients achieving a PGA of zero on Vitama.

The first is that our LTE data are long term extension study data has been published in Chad and that highlights the 130 day Romotive effect.

<unk> therapy for patients achieving a PGA or zero on dicamba, that's something that we've talked about a fair amount before and it's something we think is an important differentiating attribute.

Matt Gline: That's something that we've talked about a fair amount before, and it's something we think is an important differentiating attribute of the drug.

Of the drug.

Matt Gline: We also have noted that our Japanese partner reported positive phase three data, for Dupinaroff in atopic dermatitis, including statistically significant results in IGA and EASI, with plans to file that for approval in Japan.

We also have noted that our Japanese partner reported positive phase III data for <unk> in atopic dermatitis.

Including statistically significant results in Iga and <unk>.

With plans to file that.

<unk> in Japan.

Matt Gline: And finally, our own phase three study in atopic dermatitis is expected in the first half, of next year, which would expand our market to potentially 15 million annual topical prescriptions.

And finally, our own phase III study in atopic dermatitis is expected in the first half of next year.

Which would expand our market to potentially $15 million annual topical prescriptions.

Matt Gline: And then this is from the data, we're excited to note, that we've become the number one most prescribed branded topical for psoriasis as of eight weeks into our launch.

And then this is from the data.

Note that we have become the number one most prescribed branded topical for psoriasis as of eight weeks into our launch.

Matt Gline: So, on page six, I'll note, again, from a script volume perspective, we are excited, about how we are performing relative to other topical launches that we've seen in psoriasis.

So.

On page six.

Again from a script volume perspective.

We are excited about how we are performing relative to other topical launches that we've seen in psoriasis you can see a number of those launches and the solid lines here and we feel.

Matt Gline: You can see a number of those launches in the solid lines here, and we feel proud of, our early performance and think it's reflective of the enthusiasm around Vitama.

Proud of our early performance I think it's reflective of the enthusiasm around the camera.

Matt Gline: We also feel excited about the fact that we are approximately keeping pace with Apsalora, that's the dashed line on the slide, which is obviously in atopic dermatitis, a mark of about four times as large from a prescription perspective as psoriasis.

We also feel excited about the fact that we are approximately keeping pace without so Laura that's the dash line on the slide which is obviously in atopic dermatitis, a market about four times as large prescription perspective.

<unk> so again.

Matt Gline: So again, early days, but an exciting indicator for us.

Early days, but an exciting indicator for us and.

Matt Gline: And just as a reminder, we really are principally focused on prescription volume at this time.

Just as a reminder, we really are principally focused on prescription volume at this time.

Matt Gline: You know, the quarter here is only for the really one month or about a month of launch, data for Vitama, so the revenues are not significant, but we're focused on prescription data as we work through our coverage and contracting, and as we said, it'll be about 12 to 18 months before we expect those contracts to be in place.

The quarter here is only for the really one month or about one month of launch data for IP camera. So the revenues are not significant but we're focused on prescription data as we work through our.

Our coverage and contracting and as we've said it will be about 12 to 18 months before we expect those contracts to be in place.

On page seven I, just wanted to remind people of a few key attributes around.

Matt Gline: On page seven, I just want to remind people of a few key attributes around Vitama and, for attributes that we think will support our blockbuster potential both in psoriasis and potentially ultimately in atopic dermatitis. You know, we have the efficacy and durability that we need, and maybe most importantly, we have this off-treatment remittance benefit that we've talked about a fair amount.

Around <unk>.

Attributes that we think will support our blockbuster potential both in psoriasis and potentially ultimately in atopic dermatitis.

We have the efficacy and durability that we need and maybe most importantly, we have this often benefit that we've talked about.

Fair amounts we have.

Matt Gline: We have a broad target population with a label that permits use across the entire psoriasis, disease spectrum from mild to moderate to severe.

A broad target population with a label that permits use across the entire psoriasis disease spectrum from mild to moderate to severe we.

Matt Gline: We have no warnings or precautions at all, nor do we have any restrictions or notes about, concomitant medications on our label.

We have no warnings or precautions at all nor do we have any restrictions or notes about concomitant medications on our label.

Matt Gline: We're labeled for use on all areas of the body, and notably, that includes interpregnous, areas.

We're labeled for use on all areas of the body and notably that includes intertriginous areas.

Matt Gline: And something we've talked a little bit less about that I'll remind everyone on this call, we have statistically significant improvement in itch as early as week two in our study data.

And something we've talked a little bit less about that I'll remind everyone. On this call we have statistically significant improvement in niche as early as week two in our study data.

Matt Gline: So, on slide eight, I put that itch data in the presentation so that we can just look, at it and remind us of the data.

So on slide eight I'd put that each data in the presentation. So that we can just.

Look at it remind us of the.

Data.

Matt Gline: You can see the data across the two studies here, and one thing I'd like to call your, attention to is that we saw statistically significant separation from vehicle on impact on itch as early as week two in our studies.

You can see the data across the two studies here and one thing I'd like to call. Your attention to is that we saw statistically significant separation from the vehicle on impact on itch as early as week two.

Our studies.

Matt Gline: You can see those p-values on the slide, and notably, this comports with some of the, early feedback we're getting from prescribers and patients, which is to say that overall, I would say one of the early attributes that we're hearing is that the drug is working, faster than people expected, and we're obviously pleased to hear that from the field.

You can see those P values.

The slide and notably Comports with some of the early feedback we're getting from that.

From prescribers and patients.

Just to say that overall I would say one of the early attributes that were hearing is that the drug is working faster than people expected and we're obviously pleased to hear that.

From the field.

Matt Gline: So, I'll close on VITAMA on slide nine just to update our differentiation profile versus, the field for psoriasis.

So I'll close on V tamera.

On slide nine just to update our differentiation profile versus the field force or ISS.

Obviously, one of the main updates years that jewelry was approved recently and so we've updated this chart accordingly, and you can see we feel we have a truly differentiated profile.

Matt Gline: Obviously, one of the main updates here is that ZORI was approved recently, and so we've, updated this chart accordingly, and you can see we feel we have a truly differentiated profile.

Matt Gline: We are among the only topicals to have an unlabeled remitted benefit.

We are among the only topical is to have an on label related benefit we continue to be pleased with the fact that we have no duration limitations.

Matt Gline: We continue to be pleased with the fact that we have no duration limitations, no body surface, limitations, including no limitation against endocrinous regions.

No body surface limitations, including no limitation against Intertriginous regions, we have no safety safety warnings and precautions section on our label and then we have no label drug interactions and no country indications as well, which is something that's differentiated versus some of our some of our competitors.

Matt Gline: We have no safety warnings or precaution section on our label, and then we have no labeled, drug interactions and no contraindications as well, which is something that's differentiated versus some of our competitors.

Matt Gline: So with that, I'll move on from VTAMA, although I'm sure we'll touch on it in the Q&A section, as well.

So with that I'll move on from Vietnam, Although I'm sure we'll touch on it.

In the Q&A section as well.

Matt Gline: And I'll talk a little bit, if you jump forward to slide 11, about where we are from a clinical, perspective with all the programs backing that up.

And I'll talk a little bit if you jump forward to slide 11.

About where we are from a clinical perspective with all the programs backing that up.

Matt Gline: We're showing here a subset of our pipeline.

We're showing here a subset of our pipeline we are focusing on some of the most important and latest stage programs.

Matt Gline: We're focusing on some of the most important and latest stage programs, notably including, our VTAMA study in atopic dermatitis that I mentioned before.

Notably, including our retailer studying atopic dermatitis that I mentioned before.

We also have now begun.

Matt Gline: We also have now begun our phase three program in breprositum and dermatomyositis, and we, have our ongoing program in breprositum and lupus that I'll talk about in a moment that's going to enroll its last patient any day now.

Our phase III program in Brexit move in Dermatomyositis, and we have our ongoing program.

And then Lucas that I'll talk about in a moment, that's going to enroll as less patient.

Any day now.

And then at <unk> there've been a number of updates that we haven't put out recently.

Matt Gline: And then at Patoclinab, there have been a number of updates to the event put out recently, including the fact that multiple of their pivotal trials are initiated in indications that we think could be blockbuster indications for Patoclinab.

Including <unk>.

The fact that multiple of their pivotal trials are initiated and indications that we think could be blockbuster indications for <unk>. So we're looking forward to sharing more about that generally as those programs progress.

Matt Gline: So looking forward to sharing more about that generally as those programs progress.

Pam.

Matt Gline: You can see on slide 12 some of the sort of features of our current clinical positioning, including the fact that by the end of this year, we will have seven trials, including four pivotal trials ongoing with multiple, with progress across multiple fronts.

You can see on slide 12, some of the features of our current clinical positioning, including the fact that by the end of this year, we will have seven trials, including four pivotal trials.

Going.

With multiple multiple with progress across multiple fronts I won't talk about each of the individual studies here.

Matt Gline: I won't talk about each of the individual studies here.

Matt Gline: And we expect three additional or more additional initiations of programs in 2022, notably including, we've already initiated, as I mentioned, the programs in Patoclinab and Mycenae Gravis.

We expect that.

Three additional or more additional initiations of programs.

In 2022.

Notably, including we've already initiated as I mentioned the programs.

Yes.

You've been talking about have been facing you grab a should we expect to be initiating a thyroid eye disease study imminently.

Matt Gline: We expect to be initiating with thyroiditis study imminently.

Pam.

Matt Gline: The last thing I want to do on this call before I turn it over to Q&A is we went through the, most recent addition to our pipeline, breprositinib at PriVant last quarter at the year-end call earlier this summer.

The last thing I want to do on this call before I turn it over to Q&A as we went through.

The most recent addition to our pipeline, perhaps sitting a bit prior events.

Last quarter at the year end call earlier this summer, but I just want to reiterate some of the features of that program because its a program that we're very excited about our late stage portfolio and because as I mentioned before we are.

Matt Gline: But I just want to reiterate some of the features of that program, because it's a program that, we're very excited about in our late-stage portfolio, and because, as I mentioned before, we are expecting the final patient to enroll in our lupus study any day now.

We're expecting the final patients to enroll in our lupus study any day now and we think that'll be an important catalyst for US next year and so we wanted to continue to draw attention to that program. So.

Matt Gline: And we think that'll be an important catalyst for us next year.

Matt Gline: And so we wanted to continue to draw attention to that program.

Matt Gline: So breprositinib overall, as a reminder, is a unique dual-targeted first-in-class TIK2, and JAK1 inhibitor, which we're developing for a variety of specialty autoimmune diseases. We think that dual inhibition of TIK2 and JAK1 is scientifically important because we, think it'll potentially provide greater efficacy than agents that inhibit either one alone in inflammatory autoimmune disease where both pathways are relevant and where the interaction between the pathways is relevant.

Representing them overall as a reminder is a unique dual targeted first in class tick two in JAK, one inhibitor, which we're developing for a variety of specialty autoimmune diseases.

That dual inhibition of <unk> and JAK, one is scientifically important because we think it will potentially provide greater efficacy than agents that inhibit either one alone inflammatory autoimmune disease, where both pathways are relevant and where the interaction between the pathways relevant.

Matt Gline: We have extremely robust – as a reminder, this program, we didn't license it from Pfizer, and announced it in the last call.

We have extremely robot as a reminder, this program when license it from Pfizer and announced it last in the last call. We are extremely robust clinical data.

Matt Gline: We have extremely robust clinical data, statistically significant clinically meaningful benefits, in five placebo-controlled studies demonstrated to date in our oral formulation, including exposure of over 1,000 subjects with a safety profile consistent with approved JAK inhibitors.

Significant clinically meaningful benefits in five placebo controlled studies demonstrated to date and our oral formulation.

Including exposure of over 1000 subjects with a safety profile consistent with the approved JAK inhibitors.

Matt Gline: We think a distinctive strategy to develop the program, including development of a series, of uncrowded orphan and specialty autoimmune diseases where there's high morbidity and mortality, where there's high unmet need, and where we think the science of our drug, the dual inhibition of TIK2 and JAK1, will contribute directly to efficacy.

We have we think a distinctive strategy to develop the program including.

Development in a series of uncrowded orphan and specialty autoimmune diseases, where there is high morbidity and mortality, where there is high unmet need and where we think the science of our drug the dual inhibition of <unk> will contribute directly to efficacy. We have two ongoing registrational programs, including a single Registrational phase III study in dermatomyositis, we've already initiated as well as a large.

Matt Gline: We have two ongoing registrational programs, including a single registrational phase 3, study in dermatomyositis, which we've already initiated, as well as a large global phase 2B study in lupus that's expected to complete enrollment this month, with data expected, in the second half of next year, and that's designed to serve as one of two registrational studies in that indication, and then finally, we have strong intellectual property protection.

Global Phase <unk> study in lupus Thats expected to complete enrollment this month with data expected in the second half of next year and that's designed to serve as one of two Registrational studies in that indication.

Finally, we have strong intellectual property protection.

Matt Gline: So, on slide 14, I don't think I need to remind people in great detail, but SLE is an important, disease with obviously many, many patients, up to 300,000 people in the United States affected by it, and there's significant unmet need and obviously a disruptive and difficult clinical presentation.

So on slide 14, I don't think I need to remind people in great detail, but.

SLE is an important disease with obviously, many many patients up to 300000 people I mean that states affected by it.

In that there is significant unmet.

Unmet need and obviously.

A disruptive and difficult clinical presentation there are not.

Matt Gline: There are not very many approved therapies that work well, and those therapies are commercially, successful and provide important benefit to patients, but with significant room beyond.

Very many approved therapies that work well.

And those therapies are.

Our commercially successful and provide important benefit to patients, but with significant room beyond.

Matt Gline: So, on page 15, a reminder of a little bit of the rationale that we have for why we think, this drug will be exciting in SLE, and that's, first of all, there is data from a number of JAK1 or TIK2 inhibitors in SLE, and in both cases, we see signs of efficacy but with significant room of improvement.

So I think you've seen a reminder of a little bit of the rationale that we have.

For why we think this drug will be exciting.

And that is first of all there is data from a number of <unk> or <unk> inhibitor in SLE and in both cases, we see signs of efficacy, but with significant room of improvement. So you can see on this slide the placebo adjusted response.

Matt Gline: So, you can see on this slide the placebo-adjusted response at week 24 on the left-hand side, from a phase 2 study of baricitinib in SLE, and you can see a nice response there, as well as the phase 2 study on the right of ducravacitinib, a TIK2 inhibitor in SLE, and again, you can see a nice response there, but there's obviously significant room across both of these for improved overall efficacy, and again, we think that we have the opportunity with brevacitinib to improve on both of them.

24 on the left hand side from a phase two study of <unk>.

In SLE and you can see a nice response, there as well as the phase II study of the rate of <unk> sitting there, but take two inhibitor in SLE and again you can see a nice response, there, but there's obviously significant room across both of these for improved overall efficacy and again, we think that we have the opportunity.

With reference to.

To improve on both of them one of the rationales for that one of the reasons. We think we may we may be able to do well on page 16 is there are a number of existing indications, where we have data in both <unk> and either <unk> or both and you can see that data shown here.

Matt Gline: One of the rationales for that, one of the reasons we think we may be able to do well, on page 16 is there are a number of existing indications where we have data in both brevacitinib and either ducravacitinib, baricitinib, or both, and you can see that data shown here.

Matt Gline: We are not currently prosecuting any of these indications for brevacitinib, but to give, you a sense of just how significant our efficacy has been across multiple studies with the drug, and that makes us excited for what we expect we might be able to see in this, SLE study.

We are not currently prosecuting any of these indications of reps hitting it but they give you a sense of just how.

Just how significant our efficacy has been across multiple studies with the drug.

And that makes us excited for what we expect we might be able to see in this SLE study.

Matt Gline: So you can see on slide 17, the design of that study, as I said, we're expecting our, last patient to enroll any day now, and it's a 52-week study with a couple of different dose arms, and so you can see all of that on page 17.

So you can see on slide 17, the design of that study as I said, we are expecting our last patient to enroll any day now and its a 52 week study.

With a couple of different dose arms.

So you can see all of that on page 17.

So.

Matt Gline: So with that, I'll wrap up on some of the specific updates.

With that I'll wrap up on some of the specific updates I will note on the next slide slide.

Matt Gline: I'll note on the next slide, slide 18, we are having and we've announced our annual, Royvon Investor Day will be on Wednesday, September 28th at 11 a.m., so more details to come about that, and we're excited to hear from any of you then, and we're excited to share a number of key updates around the business, including R&D updates and others at that event.

Slide 18, just we are having and we've announced our annual erosion Investor day will be on Wednesday September 28.

At 11, a M. So more details to come about that and we're excited to.

For many of you then and we're excited to share a number of key updates around the business, including R&D updates and others.

At that event.

So I'll close and obviously the market continues to.

Matt Gline: So I'll close, and obviously the market continues to gyrate, but even with some little green, shoots, just to say we are extremely privileged from a capital position perspective, if you jump forward to page 20, I'll just point out some of the key financial items for the quarter.

To gyrate.

But.

Even with the little Green shoots just to say we are extremely privileged from a capital position perspective, if we jump forward to page 20 going.

<unk> got some of the key financial items for the quarter.

Matt Gline: So we have R&D expense of $136 million or adjusted R&D non-GAAP of $123 million, SG&A, of $149 million, or adjusted non-GAAP of $88 million, for a total adjusted net loss of $354 million, or an adjusted net loss of $211 million.

So we have.

R&D expense of $136 million or adjusted R&D non-GAAP of $123 million.

SG&A of $149 million of adjusted non-GAAP of $88 million.

Total adjusted net loss of $354 million or an adjusted net loss of.

$211 million.

Matt Gline: Our cash and cash equivalents and restricted cash stayed at about $2 billion for the quarter, which we think is important for being able to support our activities.

Our cash and cash equivalents and restricted cash stayed at about $2 billion for the quarter, which we think is important for being able to support our activities. We have balance sheet debt of approximately $417 million of which almost $33 million is sort of a standard credit facility with the carrying value of 33, and then the remainder are milestone or.

Matt Gline: We have balance sheet debt of approximately $417 million, of which only $33 million is, sort of a standard credit facility with a carrying value of $33, and then the remainder, And then we have 703,625,000 common shares issued and outstanding as of Friday.

Fair value of royalty obligations.

Related to <unk>.

Related to the camera and then we have $703 million 625000 common shares issued and outstanding as of.

Okay.

And.

Matt Gline: So finally, on slide 21, I'll just remind everybody, this is an incredibly catalyst-rich, period for our business with, obviously, regular ongoing updates on VTAMA, as well as new mid and late-stage in-licensing that's ongoing currently that I'm excited to provide updates on.

So finally on slide 21.

To remind everybody. This is an incredibly catalyst rich period for our business with obviously.

Regulatory ongoing updates on the camera as well as new mid and late stage in licensing.

That's ongoing currently and then im excited to provide updates on.

Matt Gline: We'll continue to provide updates on our L&P patent litigation at Genevans as we have them, and continue to provide updates on Quasar on our greater discovery efforts as we have them as well.

We'll continue to provide updates on our LNP patent litigation that Jennifer <unk>.

As we have them and continue to provide updates on inquiries are on our integrated discovery efforts.

Matt Gline: In addition to that, we'll be initiating multiple pivotal programs.

As we have them as well.

In addition to that we'll be initiating multiple pivotal programs I've mentioned some of these on this call we will get topline data from a number of pivotal programs within the next 12 to 15 to 18 months.

Matt Gline: I've mentioned some of these on this call.

Matt Gline: We'll get top-line data from a number of pivotal, programs within the next 12 to 15, 18 months between VTAMA and Brepp Citnib.

Between the tomo and Brexit nib.

We expect to potential data from <unk> 2001, and our phase one two trial at lower risk Myelodysplastic syndrome next year.

Matt Gline: We expect potential data from RBG 2001 in our Phase I-II trial and lower-risk malolyb splastic syndrome next year, and we continue to work towards data on other programs as well.

We continue to work towards data on other programs as well so it's an exciting period of execution for us.

Matt Gline: So it's an exciting period of execution for us.

Looking forward to connecting with everybody on our Investor day, and looking forward to continue to track many of these things, including the dicamba lunch launch in the weeks and months to come so with that I'll conclude my remarks for the day and I will open the line for Q&A and hand, it back to the operator.

Matt Gline: Looking forward to connecting with everybody on our investor day, and looking forward to continue to track many of these things, including the VTAMA launch in the weeks and months to come.

Matt Gline: So with that, I'll conclude my remarks for the day, and I'll open the line for Q&A and hand it back to the operator.

Operator: Okay.

Operator: As a reminder, to ask a question, you will need to press star 11 on your telephone.

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

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

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

Okay.

Operator: Our first question comes from David Reisinger with SVB Securities.

Our first question comes from David Risinger with S. DB Securities. Your line is now open.

Great.

David Reisinger: Your line is now open.

Thank you very much and thank you for the updates so I have a few questions first could you talk about the expected ramp of the Tam of going forward, particularly in the face of competitive dynamics.

Second could you discuss.

How youre thinking about gross to net over the next couple of years, particularly relative to street expectations in what Youre seeing from the sell side.

And then third.

Could you comment on the cash burn in the quarter and <unk>.

Remind us about your cash runway. Thank you very much.

David Reisinger: Great.

Thanks, Dave. Thank you for all those questions are all.

Good questions and I'm happy to take them. So I appreciate it.

David Reisinger: Thank you very much, and thank you for the updates.

I'll start with.

It became a question.

David Reisinger: So I have a few questions.

Which is it's early.

Early in the launch to make long term projections on a ramp.

David Reisinger: First, could you talk about the expected ramp of VTAMA going forward, particularly in the face of competitive dynamics?

We are pleased with the early prescription data and we think it sets us up well and were pleased with the engagement we've had.

With patients and physicians and with some of the early feedback we're getting on the drug. So all of that reads well you asked about competitive dynamics. The first thing I'll say, which I think is an important point that we're just going to reiterate over and over again.

We don't view this as a competitive market versus other novel agents first and foremost we view it as a competitive market versus corticosteroids.

There are literally millions of people on corticosteroids for psoriasis are literally millions of prescriptions for corticosteroids in psoriasis.

And we.

We think we have better efficacy and better tolerability that should allow us to take significant share from that whole category of agents, which is currently the standard of care.

Mainline therapies. So that's the first thing I'd say as far as the competitive landscape is concerned.

I think there is a.

We obviously have a new tactical competitor now on the market in <unk>.

It's a drug that has some nice attributes.

We think we're differentiated meaningfully between our limited benefit in our overall.

More simple safety picture without contraindications or restrictions on concomitant meds.

Also think more voice share in novel topical for psoriasis is helpful.

There will be a little bit of a rising tide effect overall, so I would say given the population that we're going after.

Im excited about our ramp and I'm not I'm not too concerned from a competitive perspective.

And I think as you see some new impressive systemic agents coming I think it'll be even more important to folks like payers to have a real off ramp to have a real opportunity for us.

For people to stay on.

Yes.

On that.

On topical therapy versus moving to some of these what I expected was very expensive systemic agents are on the biologics. So I think that will also provide a good opportunity for us in the marketplace.

David Reisinger: Second, could you discuss how you're thinking about gross-to-net over the next couple of years, particularly relative to street expectations and what you're seeing from the sell side?

On gross to net dynamics in sell side expectations, I guess I just.

It's a great question, it's an important topic.

Just to be very clear about it our expectation is that our gross to nets will be rigorous that yields will be low for the next while here. We've said 12 to 18 months to commercial contracts.

I think.

As far as App.

As.

<unk>.

Street numbers or consensus.

I won't comment specifically, but I will just say, it's important for us to say over and over again.

Thank you.

Yields are going to be low during a period when we're getting contracts in place and we think they'll normalize only after we have those commercial contracts in place and payers are converted from.

From from uncovered and Thats and Thats a function that we've talked about this before it's a function of things like the new to market blocks that make it past that make it difficult until those contracts are in place.

We are learning everyday from the marketplace, including looking at.

Formulary positioning for.

Couple of people that have gone before us and watching what that looks like.

We're just excited to see where.

Where those discussions shape out and we'll provide an update.

On contracts.

When we have it.

David Reisinger: And then third, could you comment on the cash burn in the quarter and remind us about your cash runway?

And then the last question.

On burn and runway.

I think we've said this before but it's an important point, we always look to run the business with about two years of runway.

David Reisinger: Thank you very much.

Matt Gline: Thanks, Dave.

Visibility into about two years of runway.

Matt Gline: Thank you for all those questions.

Matt Gline: They're all good questions, and I'm happy to take them, so I appreciate it.

Have a pretty broad portfolio. So it's very easy for us to optimize to extend our runway to manage our runway and so I'll say, we continue to run the business.

Matt Gline: You know, I'll start with the VTAMA question, which is, you know, it's early in the launch to make long-term projections on a ramp.

With that in mind, we have lots of options to extend runway, including partnerships delaying or eliminating lower priority programs et cetera, as well as monetizing steaks across that portfolio things like data Vance.

Matt Gline: We are pleased with the early prescription data, and we think it sets us up well. We're pleased, with the engagement we've had with patients and physicians and with some of the early feedback we're getting on the drugs.

Matt Gline: All of that reads well.

Matt Gline: You know, you asked about competitive dynamics.

That is an independent holding that back.

Sure.

Constantly looking for opportunities around so.

We are.

Excited about that I'd say, you may see some swings.

Sure.

Working capital.

Over the last couple of quarters or next quarter, just as the printer off.

Royalty financing works its way through.

But I don't think thats going to have any meaningful effect.

On long term burn.

So thanks, Dave I think that covers the three questions there.

Great. Thank you.

Please standby for next question.

Our next question comes from Dennis thing with Jefferies. Your line is now open.

Hi, guys. Thanks for taking the questions two for me.

Matt Gline: The first thing I'll say, which I think is an important point that we're just going to, reiterate over and over again, is we don't view this as a competitive market versus other novel agents, first and foremost. We view it as a competitive market versus corticosteroids, where there are literally millions of people on corticosteroids for psoriasis or literally millions of prescriptions for corticosteroids and psoriasis, and we think we have better efficacy and better tolerability that should allow us to take significant share from that whole category of agents, which is currently the standard of care, mainline therapies.

First of all can you please give us some more granularity on the launch.

Terms of who and where its being prescribed it.

Are you seeing smelter moderate.

And then just talk about.

How penetrated are are those accounts.

You guys are currently in and then secondly, perhaps on Protium event, you guys mentioned that you had an AAR to greater.

Remind us that as and when can we expect the next thank.

Thank you very much.

Yes, Thank you Dennis.

Matt Gline: So that's the first thing I'd say.

Both good questions. So I'll start on that.

Matt Gline: You know, as far as the competitive landscape is concerned, yeah, I think there's a...

And every time a question.

Matt Gline: You know, we obviously have a new topical competitor now on the market in Zorin.

We've that we've seen I think we mentioned in the slides 3000 people.

<unk> became a prescriptions.

We've been focused early on on that.

Sort of highest prescribing docs the Doc too.

Right, a significant percentage of topical prescriptions and who.

Our the general thought leaders on Nam.

Topical agents.

We've seen.

Multiple many docs have written multiple prescriptions.

And obviously there is some concentration there and then theres a whole population of doctors even in that high prescribing population that we're still we're still getting out too so getting our best without too.

I think there's a lot of room to go.

To run there.

Not sort of focused on a specific.

Severity bands.

Within those docs and so we don't have a.

A specific strategy as far as disease severity or sub setting the patient population I would say we get reports in the field.

From a variety of different patient populations, including.

Mild patients who didn't like being on steroids, but also including reports from severe psoriasis patients who for example, we're on the cusp of using a systemic agent and.

<unk> been pleased with the kind of experience in ways that.

So all of that for them. So it's been a pretty broad.

Matt Gline: It's a drug that has some nice attributes.

Matt Gline: We think we are differentiated meaningfully between our remittive benefit and our overall, more simple safety picture without contraindications or restrictions on concomitant meds.

A pretty broad patient population and a lot of interest.

In them.

In that.

In the drug from across the spectrum, where again, we're pleased with both the number of prescriptions and the number of unique prescribers.

Matt Gline: We also think more voice share and novel topicals for psoriasis is helpful.

Matt Gline: We think there will be a little bit of a rising tide effect overall.

Matt Gline: So I would say, you know, given the population that we're going after, I'm excited about, our ramp and I'm not too concerned from a competitive perspective.

And then your second question was around the engine receptor Degrader, Yes, I think we're still looking at that.

Matt Gline: And I think as you see some new impressive systemic agents coming, I think it will be, even more important to folks like payers to have a real off ramp, to have a real opportunity for people to stay on topical therapy versus moving to some of these what I expect were very expensive systemic agents or new biologics.

Matt Gline: So I think that will also provide a good opportunity for us in the marketplace.

Matt Gline: Second on gross to net dynamics and sell side expectations, I guess it's a great question.

Matt Gline: It's an important topic.

Program both.

Our data that we're sort of getting the final was tough and our competitor data.

Matt Gline: Just to be very clear about it, our expectation is that our gross to net yields will be low, for the next while here.

Got it.

To be honest, it's a kind of a program that we're watching closely.

In the context of the recent drug pricing.

Legislation.

Hey.

The bar for that is high and we're still sort of evaluating our options there and we'll provide an update.

When we've got one but I appreciate the question.

Thank you Dennis.

Thanks.

Please standby for our next question.

Okay.

Our next question comes from Neil.

The <unk> Garg with Citi. Your line is now open.

Matt Gline: We've said 12 to 18 months to commercial contracts.

Matt Gline: You know, I think as far as street numbers or consensus, I won't comment specifically, but I'll just say it's important for us to say over and over again, you know, we think our gross net yields are going to be low during the period when we're getting contracts in place and we think they'll normalize only after we have those commercial contracts in place and payers are converted from uncovered.

Hey, guys. Thanks for taking my question I was just wondering if you could talk a little bit more on them.

Matt Gline: And that's a function, we've talked about this before, it's a function of things like, the new to market blocks that make it difficult until those contracts are in place.

Matt Gline: We are learning every day from the marketplace, including looking at, you know, formulary, positioning for a couple of people that have gone before us and watching what that looks like.

Matt Gline: And we're just excited to see where those discussions shape out and we'll provide an, update on contracts when we have it.

You mentioned that you are seeing some.

Some docs writing multiple prescriptions. If you if you could talk a little bit more about just the general prescriber behavior, you're seeing are you seeing docs generally prescribed <unk> patients first see how things go with those patients and then kind of opening up their broader.

Matt Gline: And then the last question on burn and runway, you know, I think we've said this before, but it's an important point.

Matt Gline: We always look to run the business with about two years of runway or visibility into about, two years of runway.

Matt Gline: We have a pretty broad portfolio, so it's very easy for us to optimize, to extend our, runway, to manage our runway, and so I'll say we continue to run the business with that in mind.

Matt Gline: We have lots of options to extend runway, including partnerships, delaying or terminating, lower priority programs, et cetera, as well as monetizing stakes across the portfolio, things like DataVant that, you know, is an independent holding that we're constantly looking for opportunities around.

Matt Gline: So we are excited about that.

Matt Gline: You know, I'd say you may see some swings in our sort of working capital over the last, couple of quarters or next quarter, just as the Tupinarov royalty financing works its way through, but I don't think that's going to have any meaningful effect on long-term burn.

In a population of patients and then also any initial kind of feedback or anything you are hearing on.

Matt Gline: So thanks, Dave.

What's your latest that'd be great.

Yes, Thanks Nina.

So those are both it's a great question overall on both parts of it are good.

Matt Gline: I think that covers the three questions there.

I don't we don't have specific data to share right now.

David Reisinger: Great.

<unk>.

Whether it actually kind of dribbling out or not I would say anecdotally, we have a pretty wide variety of prescribing behaviors from true believers, who works with your shooting out of the gate.

That you have become more and more enthusiastic about the drug as they had positive patient experience.

I mentioned, we continue to get lots.

Lots of positive reports from doctors and patients in the field.

I'd say one attribute this coming back that we saw in our data, but I think it's been exciting to hear in the real world has been with the onset of efficacy I think patients are pleased with how fast theyre seeing results and then another set of reports that we're seeing which I mentioned are from patients who were sort of on there.

On their last gas as far as tactical as we're concerned and we're sort of evaluating progression to systemic agents and I think it's been a real breath of fresh air for that patient populations that we've heard.

We've heard positive reports from from vacuum patients.

About that from both.

Yeah.

On <unk> I, just want to say I think it is as we predicted we have not heard.

Any significant.

Rumblings about it it's not something that we think is meaningfully affecting the.

<unk> got to use the drug or meaningfully affecting the patient experience given that it's.

Given that it's transient.

And on target for the drugs, so nothing nothing new or significant around folliculitis that we think is affecting commercial behavior.

Operator: Thank you.

Thank you and thanks for listening.

Operator: Please stand by for our next question.

Please standby for our next question.

Okay.

Our next question comes from Louise Chen with Cantor. Your line is now open.

Operator: Our next question comes from Dennis Ding with Jefferies.

Dennis Ding: Your line is now open.

Hi, Thanks for taking my questions I had a few for you first one I wanted to ask about <unk>.

Dennis Ding: Hi, guys.

Breakfast at Nib, and the SME market landscape and how you think about that senior product and also why you chose this one and dermatomyositis as the first two indications and then secondly on the Japan tobacco congratulations on that news if you could be more specific on the feedback or the read through to you.

<unk> studies that would be very helpful. Thank you.

And then last one I just wanted to ask you is you know broadly what is the physician feedback on the timeline and how they view it as an addition to the market here with one of the first topical is being approved novel topical and in a long time. Thank you.

Dennis Ding: Thanks for taking the questions, too, for me.

Great. Thanks, Thank you Louise all really good questions and I appreciate them all.

Dennis Ding: First on VTAC, can you please give some more granularity on the launch in terms of who, and where it's being prescribed?

So thanks for listening.

On the first on <unk>.

Alright.

SLE.

Dennis Ding: Is it, you know, are you seeing it in the mouth and moderate?

As you know from covering the field.

As you know.

Littered with.

Lots of people will try lots of things.

Dennis Ding: And maybe talk about how penetrated are those accounts that you guys are currently in.

Dennis Ding: And then secondly, perhaps on proteovant, you know, you guys mentioned that you had, an AR degrader.

The competitive landscape, there's really there's two approved biologics.

With lots of unresponsive patients.

Many others, who experienced a partial response.

It has been historically stymied by by a combination of agents that haven't worked as well as they could ever that just for development.

Execution, so we see a huge opportunity for novel agents.

And we talked about this a little bit on our annual call and maybe some of the slides they are useful to refer to.

Dennis Ding: Remind us what that is and, you know, when can we expect the next one?

As you are looking back on it but I think there is good scientific rationale for the combination of kick too.

And Jack one.

Being important.

Lucas.

And we've seen the recent data from congratulating them on the tech side.

Embarrass hitting them on the deck one side, we put that data in this deck. So we think we have a real opportunity there as we mentioned last time.

This is a study that we're running together with Pfizer and it's capital efficient program for us with a readout next year. So we see it as a.

As an opportunity as far as why.

We've chosen these indications I'd say one is these are these are both diseases with a high morbidity and mortality.

With no approved oral therapies at all as I said in the case of Lucas the approved therapies or biologics.

And them.

There are no proved therapies targeting mortality and then maybe most importantly.

From a scientific perspective.

Looking at diseases, where we think the biology of both <unk> and JAK, one are irrelevant and potentially where we're going to see some synergistic effect between tick to Jack one that will make us better than even a combination of independent.

Jack one or two agents.

Might seem to be based on their data.

I'd say those are our main indications electric.

Lucas in dermatomyositis.

Reflect that.

So thats on breadth I think thanks for that question.

J T.

Thanks.

Thank you for them to take note of it. It's obviously, we're excited to see it.

It's always good to see.

Our past freed out.

Thank you for them to take note of it which obviously we're excited to see it.

It's always good to see.

Our past freed out in one of your programs, especially in an indication where you are currently running a study and that study is significantly smaller than our phase III studies are to see statistically significant results in the two key endpoints there.

In a smaller study and to know that they are carrying the program forward through registration is obviously, all great and it feels like a good read through for us.

Ultimately, they're going to publish the data.

Yep.

Looking forward to our own data.

And we think our data is going to read out before before they make their is publicly available.

So yes, I think I think it's a good positive read through on our efficacy.

And then finally physician feedback we've gotten a couple different versus discretion this morning and.

I'm always happy to take it because I have been incredibly pleased with the quality of the physician feedback I think look I think that we're hungry for an effective novel topical agents.

Patients were hungry for an effective novel topical agent I think some of what we are seeing in the physician feedback is just generally.

That outcome. The docs are excited to have something new to prescribing patients. We're excited to have something new and nonsteroidal to go on.

Some of the feedback we're getting is frankly, just specific to our agents in terms of the feedback on the onset of efficacy and being fast in terms of the feedback on.

On.

It's obviously early for us to be seeing the sort of quote unquote limited benefit.

But.

Early feedback that is consistent with that idea.

And so I think yes, I think it's been a really positive experience.

<unk> patients so far from what we can tell and it makes us excited for what's to come obviously, there is a lot of work to do to build that into the size of market opportunity that we think it deserves to be.

It's going to be a really really topical and psoriasis are going to be a really big opportunity and we think the Tam is going to be.

A really important drugs.

Best in class drug and that in that category. So.

The early feedback is positive and we're excited generate more of it.

Thank you thank you Luiz.

Please standby for our next question.

The next question comes from Douglas Tsao with H C. Wainwright. Your line is now open.

Dennis Ding: Thank you very much.

Hi, good morning, Thanks for taking the questions just Matt maybe just as a quick follow up to <unk> question on the tomo readout in Japan just to confirm.

Matt Gline: Yes.

Matt Gline: Thank you, Dennis.

Matt Gline: That's both good questions.

Those two studies have or that said he had the same primary endpoint as the study that you were that you are.

Currently running in atopic dermatitis correct.

Yes.

Primary and key secondary where Iga and <unk>, which are also.

You are also important endpoint for us exactly.

That's correct.

Yes, I just wanted to confirm does that sort of obviously a highlight that the read through.

Yes.

Sure exactly.

It'd be very strong.

And then also just when you think about the progress just curious in terms of the early feedback that you've been getting from payers in terms of getting contracts into place and and how they're thinking about sort of prior authorizations and where they see this being put into the treatment paradigm, because obviously to your point.

It could represent an attractive opportunity as an off ramp for more expensive biologics.

Yeah. Thanks, Doug I appreciate that question. It's a good one you obviously those are all active discussions it's hard to comment on.

Specifics of where they are but I think the point you highlighted is obviously an important point to everybody and it hasn't been lost on anybody.

It's important to have.

And offering before biologics and I think we've said before.

Our view on the treatment landscape is that we should be.

Mainstay of therapy.

Which is important.

So it's not just a sort of a pre biologic option, but really.

As the baseline of care.

And that's just sort of where we think the drug deserves to be positioned but we think obviously the factors around biologics will help us in getting the positioning we want.

And the second thing.

Mind people others.

Remember that the main thing that insurance companies care about what payers care about in determining coverage is demand obviously.

Obviously, the scientific attributes of the product or something they look at carefully and they are expert panels.

But the way that sort of gets realized.

Is that.

Is around commercial demand and so the early script volume that we're seeing here.

It is incredibly important we think.

Ensuring that we have the kind of credible.

Brian coverage that we want.

And then we talked a fair amount on the approval call about our pricing strategy and about making sure that we had both a price point that will be attractive to list price sensitive payers, but also importantly, our pri.

<unk> offered us the opportunity to offer significant rebates Q2, as pbms that are rebates sensitive. So I think all of those dynamics are important.

And.

And we think they're going to matter.

And Youre absolutely right. The biologics are really big pinpoints.

For payers right now so they're all going to be very focused on the frame that spend.

Overtime.

And then just one quick follow up I mean, how do you envision obviously getting a contract in place there. So how long do you think it will be.

Take when you look to add.

The atopic dermatitis indication should do you think that should be coming in place fairly quickly soon after that approval.

Yes, I think.

I think once the Ida indication is approved we should see adoption in relatively quickly in terms of the specifics around payer contracting and payer dynamics I think once we have the psoriasis payer contracts in place and once we have data, we'll be able to comment more specifically on that timeline, but I think it's fair to say that we expect uptake in <unk> to be relatively quick on approval.

Okay, great. Thank you so much congrats on the progress thank.

Thank you.

Matt Gline: So I'll start on the VTAMA question.

Please standby for next question.

Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is now open.

Matt Gline: You know, we've seen, I think we mentioned in the slides, 3,000 people write VTAMA prescriptions. We've been focused early on on the sort of highest prescribing docs, the docs who write, a significant percentage of topical prescriptions and who are the general thought leaders on novel topical agents. You know, we've seen multiple, many docs have written multiple prescriptions. And obviously there's some concentration there.

Matt Gline: And then there's a whole population of doctors, even in that high prescribing population, that we're still getting out to and still getting our besties out to.

Matt Gline: So I think there's a lot of room to run there.

Yes. Good morning, two for me first on the <unk>.

You mentioned that youre not seeing much of an impact but is that something you are having to educate physicians on or is that the maybe both in fact understand from the get go.

And then with respect.

Script to accelerate what are you seeing there and how do you think that's got a five dollar patient co pay or sensibility impacting this alright.

Yes. So thanks, thanks, Brian those are both there.

Matt Gline: We have not sort of focused on a specific disease severity band within those docs.

Matt Gline: And so we don't have a specific strategy as far as disease severity or subsetting the, patient population.

Matt Gline: I would say we get reports in the field from a variety of different patient populations, including mild patients who didn't like being on steroids, but also including reports from severe psoriasis patients who, for example, were on the cusp of using a systemic agent and have been pleased with their VTAMA experience in ways that may foresaw that for them.

Matt Gline: So it's been a pretty broad patient population and a lot of interest in the drug from across, the spectrum.

Both good important questions on.

Folliculitis.

How just youre very familiar with Follicular, just as a condition.

And that's all of them with allergists are pretty familiar with the license conditions.

There's not a lot of education lead to sort of explain what it is I think it's important that they have the heads up about it.

To be honest, we're just not hearing a lot about it in the field, which I think is exactly what we want.

Something that I think the doctor comfortable with but also the patient experience of it as mild as transient.

I suspect it will be <unk> powdered if many patients were asking their doctors about it after experiencing it so I think in general it's just not having.

Much read through on patients, who are prescriber behavior sort of how I understand the current situation debates.

Based on the feedback that we do have.

Matt Gline: Again, we're pleased with both the number of prescriptions and the number of unique, prescribers.

And then so we're not.

We're not sharing specifics bill rates.

But I think.

We're extremely pleased with the overall rate.

<unk>.

And I think.

That reflects the attributes of the product that reflects the sales marketing strategy and that obviously reflects the impact of the copay card program.

In all of its features in terms of getting patients on drug.

We talked a little bit about how.

The way that our co pay card disruption is also designed to help us.

The coverage process and so we're continuing to follow that as well.

Matt Gline: And then your second question was around the antigen receptor degrader.

Matt Gline: Yeah, I think we're still looking at that program, both our data that we're sort of, evaluating the final WISPs of and our competitor data.

Matt Gline: And to be honest, it's the kind of program that we're watching closely in the context, of the recent drug pricing legislation.

Matt Gline: So I would say the bar for that is high.

Matt Gline: And we're still sort of evaluating our options there, and we'll provide an update when we've, got one.

Great. Thank you. Thanks.

Matt Gline: But I appreciate the question.

Thanks, Brian .

Please standby for our next question.

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

Matt Gline: Thank you, Dennis.

Dennis Ding: Thanks.

Hi, guys. This is brendan on for Ron Thanks for taking my question.

First of all the time just wanted to ask about the Japanese <unk> study I guess looking at the baseline demographics, there and maybe the enrollment criteria would you say that's fairly reflective of the U S study and maybe what we can expect there.

Operator: Please stand by for our next question.

Operator: Our next question comes from Neva Petrito-Garg with Citi.

And then on PREPA sit nib.

Kind of building off one of the earlier questions can you maybe just tell us where you see the bar is for you on the phase II study for next year, given some of the competition.

And you also mentioned that Youre drugs do you think would be potentially better than even dual administration of that Brett inhibitors could you maybe elaborate a bit on why that would be the case, thanks very much.

Perfect.

So.

On.

The interest the study's criteria are similar patient populations are different only in the sense that.

The study in Japan, which is absolutely crucial for Japanese patients.

I think the read through is as positive and then just a reminder, that study a significantly smaller I think overall that study is smaller than either either of our individual phase III studies.

So I think Thats M.

That's an important part of that of that read through there.

And then.

I think your second question was on that was that sort of breath.

What do we think is a bar, we've talked a little bit about what the unmet need.

It looks like there I think candidly the bar has to be.

Pretty high we'd want to see superior SRA for to the approved therapies and then good data on secondary endpoints I think you had a bar for efficacy.

Reasonably high for the program.

It would be sort of one of the only oral agents. Obviously, there's no currently approved oral agents.

We have a pretty good opportunity there.

Okay.

Thank you.

Please standby for our next question.

Our next question comes from.

Neva Petrito-Garg: Your line is now open.

And as Sean Gandhi with cruise Securities. Your line is now open.

Neva Petrito-Garg: Thank you.

Hi, this is.

Alexander.

Securities going back to the conversations with Payors on a formulary position.

Neva Petrito-Garg: Hey, guys.

The discussion has been challenged at all of the launch of three <unk> at a price point that the competitor has chosen asset modified the ongoing negotiations at all with the payers that Youre seeing and then also can you remind us are you monitoring for how many tubes per month that patients use for we commented railroad practice and if you do.

Going to present this data to investors and.

What time in future might that be.

Neva Petrito-Garg: Thanks for taking my question.

Yes, Thanks, those are both well.

Both good questions about the dicamba launch actually thank you appreciate them.

Yes.

Neva Petrito-Garg: I was just wondering if you could talk a little, bit more.

<unk> price point I guess, a couple of comments one is we're not going to comment on active discussions with payers in our Qs was just approved a couple of weeks ago.

<unk>.

I don't think there is.

Real time update on the impact anyway.

We've talked a fair amount in our approval meeting about.

About why we were pricing, where we were pricing in our Q. This has been guiding to their pricing strategy for some time I think for US It was about threading the needle between.

At a low enough list price to appeal to those claims that were focused on list price, but also a high enough list price to be able to offer the kinds of rebates to the pbms.

So much of the commercial volume wise and I think we.

Feel good about our pricing strategy, considering everything that went into it.

So I won't.

I can't comment our distress strategy directly but I feel good.

About hours I also think we just have a differentiated product from from <unk> and I think the attributes of our product needs to be considered we have a limited benefit.

We've talked a fair amount about.

Their label has.

Some features that we don't including they have drug drug interactions listed.

<unk> hundred 84, metabolize drugs thats not a small thing looks.

Atorvastatin and simply statin and most contraceptives.

<unk> are included.

In their drug drug interaction profile, so I think that's something that.

We will potentially matter in practice.

And so I think there's various sort of differentiating features that will also impact payer country conversations that will also impact.

That will also impact.

Where we are and you know I think the other thing is I would say.

Refills and Joe maybe I'll say.

On the question about.

About tubes per months.

We don't currently provide guidance on that its super early obviously with many of our patients are just received the first subscription.

I think refills are.

Good indicators of happy patients and we're seeing already refills. Some number of refills just a couple of months in which makes great science. We some patients are going to use multiple tools is going to be happy on the drug. So I think you should actually be able to attract to some degrees cube.

<unk> utilization from watching the extra <unk> right I think we're happy with that and we continue to see good engagement.

And then my internal program as well.

I think overall.

It's too early to come to any long term conclusions on the refill rate or the number of <unk>, but I think the.

Early data.

It's promising to us.

Yeah.

Thanks for taking my question and congrats on the progress.

Thank you.

At this time I am showing no other questions in the queue I would now like to turn the conference back to Matt Klein for closing remarks.

Well great. Thank you operator, thank you for everyone for your questions. Thank you everyone for listening this morning, and I said it was a short call for the last one was just six weeks ago, but we're looking forward to getting back together in September for our Investor day.

And as for can you provide updates on the camera and on many other exciting things within our business over the months to come. So thank you everybody and we'll talk again soon.

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

Neva Petrito-Garg: I know, Matt, you just mentioned that you are seeing some docs write multiple prescriptions.

Neva Petrito-Garg: If you could talk a little bit more about just the general prescriber behavior you're seeing.

Neva Petrito-Garg: Are you seeing docs generally prescribed to maybe one to two patients first, see how things go with those patients, and then kind of opening up their broader population of patients, and then also any initial kind of feedback or anything you're hearing on folliculitis.

Goodbye.

The conference will begin shortly to raise Johan during Q&A you can dial one one.

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Neva Petrito-Garg: That'd be great.

Neva Petrito-Garg: Thanks.

Matt Gline: Yes, thanks, Nina.

Matt Gline: So those are both – well, it's a great question overall, and both parts of it are good.

Matt Gline: We don't have specific, data to share right now on whether docs are kind of dribbling out or not.

Matt Gline: I would say anecdotally, we have a pretty wide variety of prescriber behaviors from true believers which are shooting out of the gate and continue to shoot to docs who have become more and more enthusiastic about the drug as they've had positive patient experience.

Yes.

Matt Gline: I think I mentioned we continue to get lots of positive reports from docs and patients in the field. I would say one attribute that's coming back that we saw in our data, but I think it's been exciting to hear in the real world, has been the onset of efficacy.

[music].

Matt Gline: I think patients are pleased with how fast they're seeing results, and then another set of reports that we're seeing, which I mentioned, are from patients who were sort of on their last gasp as far as topicals were concerned, and were sort of evaluating progression to systemic agents.

Matt Gline: I think it's been a real breath of fresh air for that patient population, so we've heard positive reports from docs and patients about that from both.

Matt Gline: On folliculitis, I'll just say I think it's as we predicted.

Matt Gline: We have not heard, any significant rumblings about it.

Yes.

Matt Gline: It's not something that we think is meaningfully affecting the way docs use the drug or meaningfully affecting the patient experience given that it's transient and on target for the drug, so nothing new or significant around folliculitis that we think is affecting commercial behavior.

Matt Gline: Thank you, Nina.

Okay.

Operator: Thank you for listening.

Operator: Please stand by for our next question.

Yes.

Operator: Our next question comes from Louis Chin with Canter.

Yes.

Louis Chin: Your line is now open.

Okay.

Louis Chin: Hi.

Louis Chin: Thanks for taking my question.

Yes.

Louis Chin: So, I had a few for you.

Sure.

Louis Chin: First one I wanted to ask about, was prepositinib and the SLE market landscape and how you think about that for your product, and also why you chose this one and dermatomyositis as the first two indications.

Yes.

Louis Chin: And then secondly, on the Japan tobacco, congratulations on that news.

Louis Chin: If you could, be more specific on the feedback or the read-through to your AD studies, that would be very helpful.

Louis Chin: Thank you.

Okay.

Louis Chin: And then last one I just wanted to ask you was, you know, broadly, what is the physician feedback on Vitama and how they view it as an addition to the market here with one of the first topicals being approved, novel topicals, in a long time?

Louis Chin: Thank you.

Sure.

Matt Gline: Great.

Okay.

Matt Gline: Thank you, Louis.

Matt Gline: All really good questions, and appreciate them all.

[music].

Matt Gline: So, thanks for listening.

Matt Gline: You know, on the first, on Brepo and SLE, SLE, as you know from covering the field, is, you know, littered with lots of people who've tried lots of things.

Matt Gline: The competitive landscape is really there's two approved biologics with lots, of unresponsive patients and many others who experience a partial response.

Matt Gline: So it's a disease that has been historically stymied by a combination of agents that haven't worked as well as they could have, just poor development execution.

Yes.

Matt Gline: So we see a huge opportunity for a novel agent and you know we talked about this a little bit on our annual call and maybe some of the slides they're useful to refer to as you're looking back on it.

Matt Gline: But I think there's good scientific rationale for the combination of TIK2 and JAK1 being important in lupus and you know we've seen the recent data from dracarocitinib on the TIK2 side, we've seen baricitinib on the JAK1 side, we put that data in this deck.

Okay.

Matt Gline: So we think we have a real opportunity there and as we mentioned last time this is a study that we're running together with Pfizer and it's been a capital efficient program for us with a readout next year so we see it as a as an opportunity.

Okay.

Matt Gline: You know as far as why we've chosen these indications, I think one of these are these are both diseases with a high morbidity and mortality with no approved oral therapies at all.

Matt Gline: As I said in the case of lupus the approved therapies are biologics and them.

Okay.

Matt Gline: So no approved oral therapies, high morbidity and mortality and then maybe most importantly from a scientific perspective, we're looking at diseases where we think the biology of both TIK2 and JAK1 are relevant and potentially where we're going to see some synergistic effect between TIK2 and JAK1 that will make us better than even a combination of independent JAK1 or TIK2 agents might seem to be based on their data.

Matt Gline: So I'd say those are our main indications, lupus and dermatomyositis reflect that.

Okay.

Matt Gline: So that's on on Brepo.

Matt Gline: Thanks for that question.

Matt Gline: On JT, thanks thank you for taking note of it.

Okay.

Matt Gline: You know it's obviously we're excited to see it.

Matt Gline: It's always good to see a Pfizer readout.

Yes.

Matt Gline: Thanks, thank you for taking note of it.

Yes.

Matt Gline: You know it's obviously we're excited to see it.

Yes.

Matt Gline: It's always good to see a Pfizer, readout in one of your programs especially in an indication where you're currently running a study and I'll note that that study is significantly smaller than our phase 3 study so to see statistically significant results in the two key endpoints there in a smaller study and to know that they're carrying the program forward through registration it's obviously all great and feels like good read-through for us.

Okay.

Matt Gline: You know ultimately they're going to publish their data but we're looking forward to our own data when we think our data is going to read out before before they make theirs publicly available.

Matt Gline: So yeah I think it's a good positive read-through on our efficacy in AD.

Matt Gline: And then finally, physician feedback.

[music].

Matt Gline: So we've gotten a couple different versions of this question this morning and I'm always happy to take it because I've been incredibly pleased with the quality of the physician feedback.

Matt Gline: You know I think look I think docs were hungry for an effective novel topical agent.

Matt Gline: I think patients were hungry for an effective novel topical agent.

Matt Gline: I think some of what we are seeing in the physician feedback is just generally that that outcome the doctor excited to have something new to prescribe and patients are excited to have something new and non-steroidal to go on.

Okay.

Matt Gline: I think some of the feedback we're getting is frankly just specific to our agent in terms of the feedback on the onset of efficacy and being fast in terms of the feedback on It's obviously early for us to be seeing the sort of quote-unquote remittive benefit, but, early feedback that is consistent with that idea.

Matt Gline: And so I think, yeah, I think it's been a really positive experience for docs and patients, so far from what we can tell, and it makes us excited for what's to come.

Okay.

Matt Gline: Obviously, there's a lot of work to do to build that into the size of market opportunity, that we think it deserves to be, and we think it's going to be a really – we think topicals and serratus are going to be a really big opportunity, and we think D-Tambo is going to be a really important drug, a sort of best-in-class drug in that category.

Great.

Matt Gline: So early feedback is positive, and we're excited to generate more of it.

Matt Gline: Thank you.

Okay.

Matt Gline: Thank you, Louise.

Operator: Please stand by for our next question.

Operator: The next question comes from Douglas Tsao with HC Wainwright.

Douglas Tsao: Your line is now open.

Okay.

Douglas Tsao: Hi.

Okay.

Douglas Tsao: Good morning.

Douglas Tsao: Thanks for taking the question.

Okay.

Douglas Tsao: Matt, maybe just as a quick follow-up to Louise's question on the Vitama readout in Japan, just, to confirm, those two studies have the same – or that study had the same primary endpoint as the study that you were – that you're currently running in atopic dermatitis, correct?

Okay.

Matt Gline: Yeah.

Matt Gline: Primary and key secondary were IgA and YAZI, which are also important endpoints for us, exactly. If that's correct.

Okay.

Matt Gline: Yeah.

Okay.

Matt Gline: I just wanted to confirm, because that sort of obviously highlights that the read-through, – Yep.

Matt Gline: Exactly.

Okay.

Matt Gline: Should be very strong.

Matt Gline: Yep.

Okay.

Matt Gline: And then, also, just when you think about the progress, I'm just curious in terms of the, early feedback that you've been getting from payers in terms of getting contracts into place and how they're thinking about sort of prior authorizations and where they see this being put into the treatment paradigm, because, obviously, to your point, it could represent an attractive opportunity as an off-ramp for more expensive biologics.

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Matt Gline: Yeah.

Matt Gline: Thanks, Doug.

Matt Gline: I appreciate that question.

Matt Gline: It's a good one.

Matt Gline: Yeah.

Matt Gline: Obviously, those are all active discussions, so it's hard to comment on specifics of where, they are, but, you know, I think the point you highlighted is obviously an important point to everybody and hasn't been lost on anybody, that it's important to have an off-ramp before biologics.

Matt Gline: I think we've said before, our view on the treatment landscape is that we should be mainstay, of therapy, which is important, so not just as sort of a pre-biologics option, but really as the baseline of care, and that's just sort of where we think the drug deserves to be positioned, but we think, obviously, the factors around biologics will help us in getting the positioning we want.

Matt Gline: The second thing I'd just remind people of is, remember that the main thing that insurance, companies care about, that payers care about in determining coverage, is demand, that, obviously, the scientific attributes of the product are something they look at carefully and they have expert panels, but the way that sort of gets realized is around commercial demand, and so the early script volume that we're seeing here is incredibly important, I think, in ensuring that we have the kind of credible broad coverage that we want, and, then we talked a fair amount in the approval call about our pricing strategy and about making sure that we had both a price point that would be attractive to, you know, list price-sensitive payers, but also, importantly, a price that offered us the opportunity to offer significant rebates to those PBMs that are rebate-sensitive, so I think all of those dynamics are important.

Matt Gline: And you're absolutely right that biologics are a really big pain point for payers right, now.

Okay.

Matt Gline: So they're all going to be very focused on defraying that spend over time.

Douglas Tsao: And just one quick follow-up.

Douglas Tsao: I mean, how do you envision, obviously, getting contracts in place for psoriasis?

Okay.

Douglas Tsao: How long do you think it will take when you look to add the atopic dermatitis indication?

Douglas Tsao: Do you think that should come in place fairly quickly, soon after that approval?

Matt Gline: Yeah, I think once the AD indication is approved, we should see adoption in AD relatively quickly.

Matt Gline: In terms of the specifics around payer contracting and payer dynamics, I think once we have the, psoriasis payer contracts in place and once we have the AD data, we'll be able to comment more specifically on that timeline.

[music].

Matt Gline: But I think it's fair to say that we expect uptake in AD to be relatively quick on approval.

Douglas Tsao: Okay, great.

Douglas Tsao: Thank you so much, Matt.

Douglas Tsao: Congrats on the progress.

Matt Gline: Thank you.

Operator: Please stand by for our next question.

Operator: Our next question comes from Corinne Jenkins with Goldman Sachs.

Okay.

Corinne Jenkins: Your line is now open.

Corinne Jenkins: Yeah, good morning.

Corinne Jenkins: Two for me.

Corinne Jenkins: First, on the folliculitis, you mentioned that you're not seeing much of an impact, but is, that something you're having to educate physicians on, or is that something people seem to understand from the get-go?

Thanks.

Corinne Jenkins: And then, with respect to the script to fill rate, what are you seeing there, and how do, you think the $75 patient copay or responsibility is impacting this fill rate?

Matt Gline: Yes.

Matt Gline: So, thanks, Corinne.

Matt Gline: Those are both good, important questions.

Matt Gline: On folliculitis, dermatologists are very familiar with folliculitis as a condition, and that's, all dermatologists are pretty familiar with folliculitis as a condition. So, there's not a lot of education needed to sort of explain what it is.

Matt Gline: I think it's important that they have the heads up about it.

Matt Gline: To be honest, we're just not hearing a lot about it in the field, which I think is exactly, what we want.

Yes.

Matt Gline: It's something that I think the docs are comfortable with, but also the patient experience of it, is mild, it's transient.

Matt Gline: I suspect that we would be hearing more about it if many patients were asking their doctors, about it after experiencing it, so I think, in general, it's just not having much read through on patient or prescriber behavior is sort of how I understand the current situation to be based on the feedback that we do have.

Okay.

Matt Gline: And then, so we're not sharing specific fill rates, but I think we're extremely pleased, with the overall rate of fill prescriptions, and I think that reflects the attributes of the product, it reflects the self-marketing strategy, and it obviously reflects the impact of the co-pay card program in all of its features in terms of getting patients on drug.

Matt Gline: And, you know, we talked a little bit about how the way that our co-pay card is structured, is also designed to help us in the coverage process, and so we're continuing to follow that as well.

[music].

Corinne Jenkins: Great.

Matt Gline: Thank you.

Corinne Jenkins: Thanks, Corinne.

Operator: Please stand by for our next question.

Operator: Our next question comes from Erin Werber with Cohen.

Erin Werber: Your line is now open.

Okay.

Erin Werber: Hi guys, this is Brendan Dunn for Yaron.

Erin Werber: Thanks for taking the question.

Okay.

Erin Werber: First off to Tom, I really just wanted to ask about the Japanese 80s study.

Erin Werber: I guess looking at the baseline demographics there and maybe the enrollment criteria, would you say that's fairly reflective of the U.S. study and maybe what you can expect there?

Erin Werber: And then on RepresentNib, kind of building off one of the earlier questions, can you maybe just tell us where you see the bar is for you on this phase 2 study for next year given some of the competition?

Erin Werber: I know, and you also mentioned that your drug do you think would be potentially better than even dual administration of separate inhibitors.

Okay.

Erin Werber: Could you maybe elaborate a bit on why that would be the case?

Erin Werber: Thanks very much.

Okay.

Matt Gline: Perfect.

Yes.

Matt Gline: So on Vitama, the answer is the study's criteria are similar.

Matt Gline: Patient populations are, different only in the sense that the study in Japan was obviously exclusively Japanese patients.

Matt Gline: I think the read-through is positive.

Matt Gline: And then just a reminder, that study is significantly, smaller.

Matt Gline: I think overall that study is smaller than either of our individual phase 3 studies in AD.

Matt Gline: So I think that's an important part of that read-through there.

Okay.

Matt Gline: And then I think your second, question was on sort of Brepo and what do we think is the bar.

Matt Gline: We've talked a little bit about what the unmet need looks like there.

Matt Gline: I think, candidly, the bar has to be pretty high.

Matt Gline: We'd want to see superior SRI-4 to the approved therapies and then good data on secondary endpoints.

Matt Gline: So I think the bar for efficacy is reasonably high for the program.

Matt Gline: It would be one of the only oral agents.

Yes.

Matt Gline: Obviously, there's no currently approved oral agents.

Matt Gline: So we think we have a pretty good opportunity there.

Erin Werber: Thank you.

Operator: Please stand by for our next question.

Operator: Our next question comes from Nishant Gandhi with Truce Securities.

Nishant Gandhi: Your line is now open.

Yes.

Nishant Gandhi: Hi, this is Alex Zong with Truce Securities.

Nishant Gandhi: Going back to the conversations with payers, on formulary position, have the discussions been challenged at all with the launch of ZORI and the price point that the competitor has chosen?

Yes.

Nishant Gandhi: Has that modified the ongoing negotiations at all with the payers that you're seeing?

Sure.

Nishant Gandhi: And then also, can you remind us, are you monitoring for how many tubes per month that patients use for retirement in real-world practice?

Okay.

Nishant Gandhi: And if you do, are you going to present this data to investors?

Nishant Gandhi: And what time in the future might that be?

Okay.

Nishant Gandhi: Thanks.

Matt Gline: Yes, thanks.

Sure.

Matt Gline: Those are both good questions about the Zotama launch.

Yes.

Matt Gline: So thank you.

Yes.

Matt Gline: Appreciate them.

Matt Gline: On the Arcutis price point, I guess a couple of comments.

Yes.

Matt Gline: One is we're not going to comment on, active discussions with payers.

Matt Gline: And Arcutis was just approved a couple of weeks ago.

Yes.

Matt Gline: So I don't think there's a real-time update on the impact anyway.

Matt Gline: I think we talked a fair, amount in our approval meeting about why we were pricing where we were pricing.

Thank you.

Matt Gline: And Arcutis has been guiding to their pricing strategy for some time. I think for us, it was about threading the needle between a low enough list price to appeal to those plans that were focused on list price, but also a high enough list price to be able to offer the kinds of rebates to the PBMs where so much of the commercial volume lies. And I think we feel good about our pricing strategy considering everything that went into it.

Sure.

Matt Gline: So, you know, I won't, I can't comment on our previous pricing strategy directly, but I feel, good about ours. I also think we just have a differentiated product from Zoriiv.

Matt Gline: And I think the attributes of our product need to be considered.

[music].

Matt Gline: We have a remitted benefit that we've talked a fair amount about.

Matt Gline: Their label has some features that we don't, including, you know, they have drug-drug interactions listed with CYP3A4 metabolized drugs.

Matt Gline: That's not a small thing.

Matt Gline: That's like atorvastatin and simvastatin.

Matt Gline: And, you know, most contraceptives are included in their drug-drug interaction profiles.

Matt Gline: So I think that's something that will potentially matter in practice.

Matt Gline: And so I think there's various sort of differentiating features that will also impact payer conversations that will also impact where we are.

Matt Gline: And, you know, I think the other thing is I'd say refills in general, maybe I'll say on the question about tubes per month, you know, we don't currently provide guidance on that.

Thanks.

Matt Gline: It's super early, obviously.

Yes.

Matt Gline: Many of our patients have just received their first prescription.

Matt Gline: You know, that's, I think, refills are good indicators of happy patients. And we're seeing already refills, some number of refills just a couple months in, which I think, is a great sign that at least some patients are going to use multiple tubes, going to be happy on the drug.

Okay.

Matt Gline: So I think we should actually be able to track to some degree tube utilization from watching the NRX versus TRX rate.

Okay.

Matt Gline: I think we're happy with that.

Matt Gline: We continue to see good engagement in the MyVitamin program as well.

Okay.

Nishant Gandhi: So, you know, I think overall, it's too early to come to any long-term conclusions on the refill rate or the number of tubes.

Matt Gline: But, you know, I think the early data is promising to us.

Okay.

Nishant Gandhi: Thank you for taking the question and congrats on the progress.

Sure.

Matt Gline: Thank you.

Okay.

Operator: At this time, I am showing no other questions in the queue.

Operator: I would now like to turn, the conference back to MacLyne for closing remarks.

Yes.

Matt Gline: Well, great.

Matt Gline: Thank you, operator.

Matt Gline: Thank you for everyone for your questions.

Okay.

Matt Gline: Thank you, everyone, for listening this morning.

Matt Gline: As I said, it was a short call because our last one was just six weeks ago.

Matt Gline: We're looking forward to getting back together in September for our investor day and continue to provide updates on Vitamina and on many other exciting things within our business over the months to come.

Matt Gline: So thank you, everybody, and we'll talk again soon.

Operator: This concludes today's conference call.

Operator: Thank you for participating.

Operator: You may now disconnect.

Operator: Goodbye.

Operator: The conference will begin shortly.

Okay.

Operator: To raise your hand during Q&A, you can dial star 11.

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Q1 2023 Roivant Sciences Ltd Earnings Call

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