Q1 2022 Roivant Sciences Ltd Earnings Call
Operator: Good day and thank you for standing by.
Operator: Welcome to the Roivant 1Q 2022 earnings call.
Good day, and thank you for standing by welcome.
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.
Operator: To ask a question during the session, you will need to press star 11 on your telephone.
<unk> 2022 earnings call.
This time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session.
Dennis Ding: Thank you very much.
Douglas Tsao: And then just one quick follow up.
To ask a question. During this session you will need to press star one on your telephone.
Operator: Please be advised that today's conference is being recorded.
Please be advised that today's conference is being recorded.
I would now like to hand, the conference over to your speaker today.
Paul Davis head of communication. Please go ahead.
Operator: I would now like to hand the conference over to your speaker today, Paul Davis, Head of Communication.
Matt Gline: Yes.
Douglas Tsao: I mean, how do you envision obviously getting contracts in place for psoriasis?
Good morning, and thank you for joining today's call to discuss financial results for the quarter ended June 32022.
Paul Davis.
Presenting today, we have Mike Weiner, Chief Executive Officer.
For those dialing in by conference call you can find the slides presented today as well as the press release announcing these updates on our IR website at Www Dot investor Dot Dot Dot Com will also be providing the slide numbers as we presented.
I would like to remind you that we will make certain forward looking statements during today's presentation.
Including those related to our financial performance and the potential attributes of our products and product candidates.
We encourage you to review the information that was about.
Please see the earnings release and Form 10-Q filed this morning for more information regarding these forward looking statements related risks and uncertainties.
Well begin with my final review key business updates across braeburn to advance and provide a financial update we will end the call with a Q&A session.
Operator: Please go ahead.
Matt Gline: Thank you, Dennis.
Douglas Tsao: How long do you think it will be?
I'll turn it over to Matt.
Thank you Paul.
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 are about six weeks ago. When we presented our year end results.
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.
Matt Gline: That's both good questions.
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 we'll make some time for Q&A.
Paul Davis: I'm Paul Davis, the Head of Communications at Roivant.
Matt Gline: So I'll start on the VTAMA question.
So as a reminder, we're just 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 the camera, but what you will spend a little bit of time on this morning.
That is backed by a broad clinical stage pipeline, including multiple.
Pivotal or Registrational study is currently ongoing.
Our chip the clinic discovery program, including our proprietary <unk> platform.
We are using to bolster that pipeline.
The discovery stage.
<unk> of sources of Asian metric potential upside, including.
Our Japan IP portfolio.
And all of that is 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 financing and develop all of our all of our programs across our pipeline.
Paul Davis: Presenting today, we have Matt Gline, our Chief Executive Officer.
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.
Douglas Tsao: Yaron Werber, David Risinger, Andrew Baum, Louise Chen, Douglas Tsao, Allison Bratzel, craziest, simplified federal grant.
So I'll start on page five with a brief update on the dicamba launch and I'll say first of all I'm incredibly pleased with the very early bad information here.
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.
Douglas Tsao: We expect FDA to be relatively quick on approval.
Obviously as we've said a number of occasions, we are principally tracking prescriptions at this time and.
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 of months and but we feel the script volume and the early feedback from providers has been.
Matt Gline: So I think there's a lot of room to run there.
Douglas Tsao: Okay.
Paul Davis: For those dialing in via 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. We'll also be providing the current slide numbers we present to help you follow along.
Douglas Tsao: Thank you so much.
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.
Very very strong there are a few key updates in recent weeks around this launch.
Paul Davis: We strongly encourage you to review the information that we filed with 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.
Matt Gline: We have not sort of focused on a specific disease severity band within those docs.
Douglas Tsao: Congrats on the progress.
Matt Gline: We'll review key business updates across Roivant in advance and provide a financial update.
Matt Gline: And so we don't have a specific strategy as far as disease severity or subsetting the, patient population.
Matt Gline: We'll end the call with a Q&A session.
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.
The first is our LTE data are long term extension study data has been published in Jama and that highlights the 30 day relative effect.
Off 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: With that, I'll turn it over to Matt.
Matt Gline: So it's been a pretty broad patient population and a lot of interest in the drug from across, the spectrum.
Douglas Tsao: Thank you.
Operator: Please stand by for our next question.
Corinne Jenkins: Our next question comes from Corinne Jenkins with Goldman Sachs.
Of the drug.
We also have noted that our Japanese partner at reported positive phase III data for <unk> in atopic dermatitis.
Including statistically significant results in Iga and <unk>.
With plans to file for approval in Japan.
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.
Corinne Jenkins: Your line is now open.
Matt Gline: Thank you, Paul.
Matt Gline: Again, we're pleased with both the number of prescriptions and the number of unique, prescribers.
Corinne Jenkins: Good morning to for me.
And then this is from the data.
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?
To note that we've become the number one most prescribed branded topical for psoriasis as of eight weeks into our launch.
Matt Gline: And good morning, everybody, and thank you for joining our first quarter earnings call.
Matt Gline: And then your second question was around the antigen receptor degrader.
Corinne Jenkins: And then, with respect to just 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?
So.
On page six.
Again from a script volume perspective.
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.
Matt Gline: I think we're still looking at that program, both our data that we're sort of getting the, final wisps of and our competitor data.
Matt Gline: Yes.
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.
We are excited about how we are performing relative to other topical launches that we've seen in psoriasis.
Matt Gline: So I would say 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.
See a number of those launches and the solid lines here and we feel.
Proud of our early performance I think it's reflective of the enthusiasm around the camera.
We also feel excited about the fact that we are approximately keeping pace with apps Laura that's the dash line on this slide which is obviously in atopic dermatitis, a market about four times as large prescription perspective.
Psoriasis so again.
Early days, but an exciting indicator for us.
As a reminder, we really are principally focused on prescription volume at this time.
Matt Gline: But I appreciate the question.
Matt Gline: So, thanks, Corinne.
Yeah.
The quarter here is only for the really one month or about a month of launch data for IP camera. So the revenues are not significant but we're focused on long.
Prescription data as we worked through our.
Our coverage and contracting and as we've said it'll be about 12 to 18 months before we expect those contracts to be in place.
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.
Matt Gline: Thank you, Dennis.
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.
On page seven I, just wanted to remind people of a few key attributes around at around <unk> attributes.
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 the TAMA, which we will spend a little bit of time on this morning. That is backed by a broad clinical stage pipeline, including multiple pivotal and registrational studies currently ongoing.
Matt Gline: Thanks.
Matt Gline: Our TIPTA clinic discovery program, including our proprietary Quasar platform that we are using to bolster that pipeline at the discovery stage.
Matt Gline: A number of sources of asymmetric potential upside, including our GenEvent 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.
Attributes that we think will support our blockbuster potential both in psoriasis and potentially ultimately in atopic dermatitis.
Matt Gline: So, I'll start on page five with a brief update on the TAMA launch, and I'll say, first of all, I'm incredibly pleased with the very early information here.
Matt Gline: 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.
Operator: Please stand by for our next question.
We have the efficacy and durability that we need and maybe most importantly, we have this off treatment benefit that we've talked about a fair amount.
Neva Petrito-Garg: Our next question comes from Neva Petrito-Garg with Citi.
Neva Petrito-Garg: Your line is now open.
Neva Petrito-Garg: Hey, guys.
We have a broad target population with a label that permits used across the entire psoriasis disease spectrum from mild to moderate to severe.
Neva Petrito-Garg: Thanks for taking my question.
We have no warnings or precautions at all nor do we have any restrictions or notes about concomitant medications on our label.
We're labeled for use on all areas of the body and notably that includes intertriginous areas.
Neva Petrito-Garg: I was just wondering if you could talk a little, bit more.
It's something we've talked a little bit less about that I'll remind everyone. On this call. We have statistically significant improvement in etch as early as week two in our study data.
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.
Matt Gline: So, there's not a lot of education needed to explain what it is.
Matt Gline: I think it's important that they have the heads up about it.
So on slide eight I put that each day.
The presentation, so that we can just.
Look at it remind us of the <unk>.
Data.
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.
Our studies.
You can see those P values on the slide and notably just can.
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?
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.
Matt Gline: It's just something that I think the docs are comfortable with, but also the patient, experience of it is mild, it's transient.
<unk> with some of the early feedback we're getting from that from prescribers and patients.
Matt Gline: I suspect that we would be hearing more about it if many patients were asking their doctors, about it after experiencing it.
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.
Matt Gline: 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.
From the field.
And so on.
I'll close on V tamera.
On slide nine just to update our differentiation profile versus the field force or ISS.
Matt Gline: Obviously, it is still the early days.
Obviously, one of the main update yours 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: 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.
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 the TAMA.
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.
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.
Nobody surface limitations, including no limitation against Intertriginous regions, we have no safety or 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.
So with that I'll move on from Vietnam, Although I'm sure we'll touch on it.
Neva Petrito-Garg: And then also any initial kind of feedback or anything you're hearing on folliculitis.
Matt Gline: And then, so we're not sharing specific fill rates, but I think we're extremely pleased, with the overall rate of filled prescriptions, and I think that reflects the attributes of the product, it reflects the sales and marketing strategy, and it obviously reflects the impact of the CoPayCard program in all of its features, in terms of getting patients on drug.
In the Q&A section as well.
And I'll talk a little bit if you jump forward to slide 11.
Neva Petrito-Garg: That'd be great.
Where we are from a clinical perspective with all the programs backing that up.
Neva Petrito-Garg: Thanks.
Matt Gline: Yes, thanks, Nina.
We're showing here a subset of our pipeline we are focusing on some of the most important and latest stage programs.
Matt Gline: So those are both – well, it's a great question overall, and both parts of it are good.
Matt Gline: I don't – we, don't have specific data to share right now on, you know, whether docs are kind of dribbling out or not.
Notably, including RV, Thomas studying atopic dermatitis that I mentioned before.
Matt Gline: I would say anecdotally we have a pretty wide variety of prescriber behaviors from true believers who were sort of 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.
Matt Gline: We also have noted that our Japanese partner reported positive phase three data for Dupinirov in atopic dermatitis, including statistically significant results in IGA and YAZI, with plans to file that for approval in Japan.
Matt Gline: You know, 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. I think patients are pleased with how fast they're seeing results.
Matt Gline: 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.
We also have now begun.
Our phase III program in Brexit, maybe dermatomyositis and we have our ongoing program.
Lucas I'll talk about in a moment, that's going to enroll the last patient.
Any day now.
Matt Gline: And I think it's been a real breath of fresh air for that patient population.
<unk>.
And then at <unk> there've been a number of updates let me put out recently.
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.
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 multiple with progress across multiple fronts I won't talk about each of the individual studies here.
And 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 were talking about have been basically congrats should we expect to be initiating a thyroid eye disease study imminently.
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.
Matt Gline: So we've heard positive reports from docs and patients about that from both.
Matt Gline: And, you know, we talked a little bit about how the way that our CoPayCard is structured, is also designed to help us in the coverage process, and so we're continuing to follow that as well.
Pam.
The last thing I want to do on this call before I turn it over to Q&A as we went through.
Matt Gline: And then this is from the data.
Matt Gline: On folliculitis, I'll just say I think it's as we predicted.
Corinne Jenkins: Great.
Matt Gline: 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.
Matt Gline: We have not heard any significant rumblings about it. 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.
The most recent addition to our pipeline, perhaps sitting hibbett prior events.
Matt Gline: Thank you.
Last quarter or at the year end call earlier this summer, but just wanted 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 expecting the final patients to enroll in our lupus study any day now.
Matt Gline: So nothing new or significant around folliculitis that we think is affecting commercial behavior.
Corinne Jenkins: Thanks, Ron.
Matt Gline: Thank you, Nina.
Operator: Please stand by for our next question.
Neva Petrito-Garg: Thank you for listening.
Yaron Werber: Our next question comes from Yaron Werber with Cohen.
That'll be an important catalyst for us next year and so we wanted to continue to draw attention to that program. So.
Operator: Please stand by for our next question.
Yaron Werber: Your line is now open.
Perhaps hitting 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.
Louis Chin: Our next question comes from Louis Chin with Cantor.
Yaron Werber: Hi, guys.
Louis Chin: Your line is now open.
Yaron Werber: This is Brendan Onfrey, Ron.
Think 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 in inflammatory autoimmune disease, where both pathways irrelevant and where the interaction between the pathways relevant.
Louis Chin: Hi.
Yaron Werber: Thanks for taking the question.
We have an extremely robust as a reminder, this program win licensing from Pfizer and announced it last in the last call. We are extremely robust clinical data.
Louis Chin: Thanks for taking my question.
Yaron Werber: First off, I really just wanted to ask about the Japanese-Asian study.
Louis Chin: So I had a few for you.
Yaron 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 we can expect there?
Significant clinically meaningful benefits in five placebo controlled studies demonstrated to date and our oral formulation.
Louis Chin: First one I wanted to ask about, was grepositinib 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.
Louis Chin: And then secondly, on the Japan tobacco, congratulations on that news.
Including exposure of over 1000 subjects with a safety profile consistent with the prudent JAK inhibitors.
Louis Chin: If you could be more specific on the feedback or the read-through to your AD studies, that would be very helpful.
We have we think a distinctive strategy to develop the program including.
Louis Chin: Thank you.
Development in a series of uncrowded orphan and specialty autoimmune diseases, where theres high morbidity and mortality, where there is high unmet need and where we think the science of our drugs. The dual inhibition of <unk> and JAK, one will contribute directly to efficacy. We have two ongoing registrational programs, including a single Registrational phase III study in dermatomyositis, which we've already initiated as well as a large.
Yaron Werber: And then, on Breprositinib, 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?
Yaron Werber: I know, and you also mentioned that your drug, you think, would be potentially better than, even dual administration of separate inhibitors.
Yaron Werber: Could you maybe elaborate a bit on why that would be the case?
Global Phase III study in lupus, that's attracted to complete enrollment this month with data expected in the second half of next year and Thats designed to serve as one of two Registrational studies in that indication.
Yaron Werber: Thanks very much.
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.
Matt Gline: Perfect.
Finally, we have strong intellectual property protection.
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.
Matt Gline: We also feel excited about the fact that we are approximately keeping pace with Apsalora.
So on slide 14, I don't think I need to remind people in great detail, but.
Matt Gline: That's the dashed line on the slide, which is obviously in atopic dermatitis, a market, about four times as large from a prescription perspective as psoriasis.
<unk> is an important disease with obviously, many many patients up to 300000 people in the United States affected by it.
In that there is significant unmet.
Unmet need and obviously <unk>.
Disruptive and difficult clinical presentation, there are not.
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, again, early days, but an exciting indicator for us, and just as a reminder, we really, are principally focused on prescription volume at this time.
Matt Gline: So, on VITAMA, the answer is the study's criteria are similar.
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.
Matt Gline: Patient populations, are different only in the sense that the study in Japan was obviously exclusively Japanese patients.
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.
So I think 15, a reminder of a little bit of the rationale that 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.
Matt Gline: I think the read-through is positive.
Matt Gline: We have no warnings or precautions at all, nor do we have any restrictions or notes about, concomitant medications on our label.
For why we think this drug will be exciting in SLE and that's first of all there is data from a number of JAK <unk> inhibitors in SLE and in both cases, we see signs of efficacy, but with significant room of improvement. So you can see on this slide.
Matt Gline: We're labeled for use on all areas of the body, and notably, that includes interperiginous, areas, and something we've talked a little bit less about that I'll remind everyone on this call.
Matt Gline: We have statistically significant improvement in itch as early as week two in our study, data.
Matt Gline: So, on slide eight, I've put that itch data in the presentation so that we can just look, at it and remind us of the data.
Matt Gline: And then just a reminder, that study is significantly smaller.
Placebo adjusted response.
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.
Matt Gline: I think overall that study is smaller than either of our individual phase 3 studies in AD.
<unk> 24 on the left hand side from a phase II study of <unk>.
In SLE and you can see a nice response, there as well as the phase II study of the rights 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.
Matt Gline: So, I think that's an important part of that read-through there.
Matt Gline: And then I think your second question was on sort of BREPO and what do we think is the bar.
Matt Gline: You know, we've talked a little bit about what the unmet need looks like there.
With requisite nib to to.
Matt Gline: You know, I think, candidly, the bar has to be pretty high.
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: We'd want to see superior SRI-IV to the approved therapies and then good data on secondary endpoints.
Matt Gline: So, I think, you know, the bar for efficacy is reasonably high for the program.
Matt Gline: It would be sort of one of the only oral agents.
Matt Gline: Obviously, there's no currently approved oral agents.
We are not currently prosecuting any of these indications represent in it but to give you a sense of just how.
Matt Gline: So, I think we have a pretty good, opportunity there.
Just how significant our efficacy has been across multiple studies with the drug.
Matt Gline: Thank you.
And that makes us excited for what we expect we might be able to see.
Operator: Please stand by for our next question.
In this <unk> study.
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 its a 52 week study.
Nishant Gandhi: Our next question comes from Nishant Gandhi with Truist Securities.
Nishant Gandhi: Your line is now open.
With a couple of different dose arms.
You can see all of that on page 17.
Yes.
Nishant Gandhi: Hi, this is Alex Zong with Truist Securities.
No.
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?
Nishant Gandhi: Has that modified the ongoing negotiations at all with the payers that you're seeing?
With that I'll wrap up on some of the specific updates I will note on the next slide slide.
Slide 18, just we are having and we've announced our annual revenue Investor day will be on Wednesday September 28.
Nishant Gandhi: And then also, can you remind us, are you monitoring for how many tubes per month that patients use for retirement and real-world practice?
Nishant Gandhi: And if you do, are you going to present this data to investors and at what time in the future might that be?
At 11, a M. So more details to come about that and we're excited to.
Nishant Gandhi: Thanks.
For many of you there and we're excited to share a number of key updates around the business, including R&D updates and others.
At that event.
Matt Gline: Yes, thanks.
So I'll close and obviously the market continues to.
To gyrate.
But.
Even with the little Green shoots just to say we are extremely privileged from a capital position perspective, if you jump forward to page 20.
<unk> got some of the key financial items for the quarter.
So we have.
R&D expense of $136 million or adjusted R&D non-GAAP of $123 million.
SG&A of 149 million, our adjusted non-GAAP of $88 million.
Total adjusted net loss of $354 million or an adjusted net loss of $211 million.
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 where.
Fair value of royalty obligations.
Related to <unk>.
Related to the camera and then we have 703 million passengers around 25000 common shares issued and outstanding as of.
Friday.
Okay.
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.
The camera as well as new mid and late stage in licensing.
That's ongoing currently and I'm excited to provide updates on.
We'll continue to provide updates on our LNP patent litigation that Jennifer <unk>.
As we have them and continue to provide updates on <unk> or on our greater discovery efforts.
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.
Between Panama and Brexit Nib.
We expect to potential data from <unk> 2001 in our phase one two trial at lower risk Myelodysplastic syndrome next year.
We continue to work towards data on other programs.
Grams as well 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 time of launch and launch in the weeks and months to come so with that I'll conclude my remarks for today and I'll open the line for Q&A and hand, it back to the operator.
Matt Gline: Those are both good questions about the decamba launch.
Matt Gline: Thank you.
Minder to ask a question you will need to press star one on your telephone please standby, while we compile the Q&A roster.
Matt Gline: Appreciate them.
Our first question comes from David Risinger with S. VB Securities. Your line is now open.
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?
Matt Gline: On the Arcutis price point, I guess a couple of comments.
Great.
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 timbre 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 remind.
Remind us about your cash runway. Thank you very much.
Louis Chin: Thank you.
Matt Gline: One is, we're not going to comment on active discussions with payers.
Thanks, Dave. Thank you for all those questions. They are all good.
Matt Gline: Great.
Matt Gline: And Arcutis was just approved a couple of weeks ago.
Good questions and I'm happy to take them. So I appreciate it.
I'll start with.
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.
Matt Gline: Thank you, Louise.
Matt Gline: So, I don't think there's a real-time update on the impact anyway.
It became a question.
Which is yes.
Early in the launch to make long term projections on a ramp.
Matt Gline: So, I'll close on VITAMA on slide nine just to update our differentiation profile versus, the field for psoriasis.
Matt Gline: All really good questions and appreciate them all.
Matt Gline: I think we talked a fair amount in our approval meeting about why we were pricing where we were pricing.
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.
Matt Gline: So thanks, for listening.
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.
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 over again.
Matt Gline: You know, I'm the first on breakout with SLE.
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: SLE, as you know from covering the field, is, you know, littered with lots of people who have tried lots of things.
Matt Gline: So, I can't comment on Arcutis' pricing strategy directly, but I feel good about ours. I also think we just have a differentiated product from Zoriiv.
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: And I think the attributes of our product need to be considered.
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.
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. So, we see a huge opportunity for a novel agent.
Matt Gline: We have a remitted benefit that we've talked a fair amount about.
Matt Gline: And, you know, we talked about this a little bit on our annual call and maybe some of the, slides there are useful to refer to as you're looking back on it.
Matt Gline: Their label has some features that we don't, including they have drug-drug interactions listed with CYP3A4 metabolized drugs.
There are literally millions of people on corticosteroids for psoriasis are literally millions of prescriptions for corticosteroids in psoriasis.
Matt Gline: But I think there's good scientific rationale for the combination of TIK2 and JAK1 being important in lupus.
Matt Gline: That's not a small thing.
And we.
Matt Gline: And, you know, we've seen the recent data from dracarocitinib on the TIK2 side.
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.
Matt Gline: We've seen baricitinib on the JAK1 side. We put that data in this deck.
Matt Gline: That's like atorvastatin and simvastatin.
Matt Gline: And most contraceptives are included in their drug-drug interaction profiles.
Matt Gline: So, we think we have a, real opportunity there.
Matt Gline: So, I think that's something that.., will potentially matter in practice.
Mainline therapies. So that's the first thing I'd say as far as the competitive landscape is concerned.
Matt Gline: And so I think there's there's various sort of differentiating features that will also impact player conversations that will also impact 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, about tubes per month, you know, we don't currently provide guidance on that.
Matt Gline: It's super early.
Matt Gline: 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.
Matt Gline: Obviously, many of our patients have just received their first prescription.
I think there is a.
Matt Gline: You know, that's, I think, refills are good indicators of happy patients.
Matt Gline: And we're seeing already refills, some number of refills just a couple months in, which I think is a great sign.
We obviously have a new tactical competitor now on the market absorbed.
Matt Gline: At least some patients are going to use multiple tubes, going to be happy on the drug.
Matt Gline: So I think you should actually be able to track to some degree, tube utilization from watching the NRX versus TRX rate.
It's a drug that has some nice attributes.
Matt Gline: We are among the only topicals to have an on-label remittive benefit.
Matt Gline: We continue to be pleased with the fact that we have no duration limitations, no body surface, limitations, including no limitation against intracritinous regions.
We are differentiated meaningfully between our immediate benefit in our overall.
Matt Gline: We have no safety or 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.
More simple safety picture without contraindications or restrictions on concomitant meds that said, we also think more voice share in novel topical for psoriasis is helpful. We think there will be a little bit of a rising tide effect overall, so I would say given the population that we're going after.
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.
Matt Gline: So, we see it as an opportunity.
Matt Gline: I think we're, we're happy with that.
Matt Gline: We continue to see good engagement in the MyVitamin program as well.
Matt Gline: 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: 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.
Operator: At this time, I am showing no other questions in the queue.
Matt Gline: But, you know, I think the early data is, is promising to us.
Matt Gline: I would now like to turn the
Nishant Gandhi: Thank you for taking the question and congrats on the progress.
Matt Gline: conference back to Matt Glein for closing remarks.
Nishant Gandhi: Thank you.
Matt Gline: We're showing here a subset of our pipeline.
Matt Gline: Well, great.
I'm excited about our ramp and I'm not I'm not too concerned from a competitive perspective.
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.
Matt Gline: We also have now begun our phase three program in breprosyntemib and dermatomyositis, and, we have our ongoing program in breprosyntemib and lupus that I'll talk about in a moment that's going to enroll its last patient any day now.
Matt Gline: I've mentioned some of these on this call.
Matt Gline: Thank you, operator.
Matt Gline: And then at Batoclinab, 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 Batoclinab, so looking forward to sharing more about that generally as those programs progress.
Matt Gline: We'll get top-line data from a number of pivotal, programs within the next 12 to 15, 18 months between VCAMA and Brepp Citnib.
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 progress across multiple fronts.
Matt Gline: We expect potential data from RBG2001 in our Phase I-II trial of lower-risk malnourished spastic syndrome next year, and we continue to work towards data on other programs as well.
Matt Gline: I won't talk about each of the individual studies here.
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 VCAMA launch in the weeks and months to come.
As you see some new impressive systemic agents coming.
Matt Gline: So it's an exciting period of execution for us.
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 Batoclinab and Mycenae Gravis we expect to be initiating with thyroiditis study imminently.
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, brepsitinib at Pryvant, last quarter at the year-end call earlier this summer.
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, 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.
Matt Gline: So brepsitinib 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.
I think it will be even more important to folks like payers to have a real off ramp to have a real opportunity for <unk>.
Matt Gline: We have extremely robust – as a reminder, this program, we licensed it from Pfizer and, announced it in the last call.
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.
Matt Gline: We think a distinctive strategy to develop the program, including development in 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.
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.
Matt Gline: And then 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.
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.
For people to stay on.
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.
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.
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.
Yes.
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, 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 with that, I'll wrap up on some of the specific updates.
On that.
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.
On topical therapy versus moving to some of these what I expected with very expensive systemic agents or new biologics. So I think that will also provide a good opportunity for us in the marketplace.
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, 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.
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.
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.
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 VCAMA, as well as new mid and late-stage in-licensing that's ongoing currently, that I'm excited to provide updates on.
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.
Matt Gline: We'll continue to provide updates on our L&P patent litigation at Genovant as we have them, and continue to provide updates on Quasar on our greater discovery efforts as we have them as well.
Operator: Okay.
Matt Gline: In addition to that, we'll be initiating multiple pivotal programs.
Operator: As a reminder, to ask a question, you will need to press star 11 on your telephone.
Matt Gline: Thank you for everyone for your questions.
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.
Second on gross to net dynamics in sell side expectations I guess.
Operator: Thank you for participating.
Matt Gline: We're looking forward to getting back together in September for our investor day.
Operator: You may now disconnect.
Matt Gline: And we're continuing to provide updates on Vitamina and on many other exciting things within our business over the months to come.
Operator: Goodbye.
Matt Gline: So thank you everybody.
Operator: The conference will begin shortly.
Matt Gline: And we'll talk again soon.
It's a great question, it's an important topic.
Operator: Please stand by while we compile the Q&A roster.
Operator: To raise your hand during Q&A, you can dial star 11.
Operator: This concludes today's conference call.
David Reisinger: Our first question comes from David Reisinger with SVB Securities.
Just to be very clear about it our expectation is that our gross to nets will be our gross net yields will be low for the next while here. We've said 12 to 18 months to commercial contracts.
David Reisinger: Your line is now open.
Matt Gline: You know, as far as why we've chosen these indications, I think one of 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.
Matt Gline: And so, no approved oral therapies, high morbidity and mortality.
I think.
Matt Gline: 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 indication selection criteria.
As far as App.
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.
Matt Gline: And we think both lupus and dermatomyositis reflect that.
Matt Gline: So, that's on BREPO.
We think we think that 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.
Matt Gline: Thanks for that question.
Matt Gline: On JT, thank you for taking note of it.
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 makes it difficult until those contracts are in place.
We are learning everyday from the marketplace, including looking at.
Formulary positioning for.
A couple of people that have gone before us and watching what that looks like and we're just excited to see where were those discussions shape out and we'll provide an update.
Matt Gline: You know, it's obviously we're excited to see it.
Matt Gline: It's always good to see a positive readout in one of your programs, especially in an indication where you're currently running a study.
On contracts.
When we have it.
And then the last question.
On burn and runway.
Matt Gline: And I'll note that that study is significantly smaller than our phase three 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 is obviously all great and feels like a good read-through for us.
Matt Gline: You know, ultimately, they're going to publish their data, but we're looking forward to our own data.
Matt Gline: And we think our data is going to read out before they make theirs publicly available.
Matt Gline: And then finally, physician feedback.
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.
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: So, yeah, I think it's a good positive read-through on our efficacy in AD.
I should say visibility into about two years of runway, 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, we have lots of options to extend runway, including partnerships delaying or terminating lower priority programs et cetera, as well as monetizing states across that portfolio things like data event.
That is an independent holding that back.
We're constantly looking for opportunities around so.
We are.
Excited about that I'd say, you may see some swings.
Our.
Working capital.
Over the last couple of quarters or next quarter, just as the <unk>.
Royalty financing works its way through but.
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.
David Reisinger: Great.
David Reisinger: Thank you very much, and thank you for the updates.
Great. Thank you.
Please standby for next question.
Our next question comes from Dennis Yang with Jefferies. Your line is now open.
David Reisinger: So I have a few questions.
Yes.
Hi, guys. Thanks for taking the questions two for me.
First of all can you please give some more granularity on the launch.
Of who and where its being prescribed is that are you seeing smelter moderate.
Just talk about.
How penetrated are are those accounts.
You guys are currently in and then secondly, perhaps on Proteus.
You guys mentioned that you had an AAR to greater.
Remind us that as and when can we expect the next thank you very much.
Yes. Thank you Dennis said, but both both good questions. So I'll start on that.
David Reisinger: First, could you talk about the expected ramp of VTAMA going forward, particularly in the face of competitive dynamics?
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?
And every time a question.
We've that we've seen I think we mentioned in the slides 3000 people.
Right <unk> prescriptions.
Been focused early on on the sort of highest prescribing docs the docs.
Right, a significant percentage of topical prescriptions and who.
Our the general thought leaders.
Matt Gline: You know, I think, look, I think docs were hungry for an effective novel topical agent.
Novel 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. So I think there's a lot of room to.
To run there.
We have not sort of focused on a specific <unk>.
Severity bands.
We didnt those docs and so we don't have a <unk>.
Pacific strategy as far as disease severity or sub setting with patient population.
I would say we get reports in the field.
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 have been pleased with the kind of experience in ways that May force all that for them. So it's been a pretty broad.
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.
And then your second question was around the antigen receptor to greater yes, I think we're still looking at that.
Program both.
Our data that we're sort of getting the final wisps oven our competitor data.
And to be honest, it's the kind of program that we're watching closely.
In the context of the recent drug pricing.
So I would say.
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 guys.
Thanks.
Please standby for our next question.
Okay.
Our next question comes from Neil.
The <unk> Garg with Citi. Your line is now open.
Hey, guys. Thanks for taking my question I was just wondering if you could talk a little bit more on them.
You mentioned that you are seeing some.
Some docs writing multiple prescriptions, if you could talk a little bit more about the general prescriber behavior, you're seeing are you seeing docs generally prescribed <unk> one to two patients first see how things go with those patients and then kind of opening up their broader.
In a population of patients and then also any initial kind of feedback or anything you are hearing on <unk>.
Your line is that'd be great.
Yes, Thanks Nina.
So those are both it's a great question overall on both parts of it are good.
I don't we don't have specific data to share right now.
On.
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.
We're shooting out of the gate and continued to shoot to.
<unk> have become more and more enthusiastic about the drug as they had positive patient experience.
I think I mentioned, we continue to get.
Lots of positive reports from vaccine patients in the field.
I'd say, one actual group, it's 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.
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 outcome.
On their last gas as far as tactical as we're concerned and we're sort of evaluating progression just systemic agents and I think it's been a real breath of fresh air for that patient population. So we have heard.
Matt Gline: The docs are excited to have something new to prescribe and patients are excited to have something new and non-steroidal to go on.
We've heard positive reports from from vacuum patients.
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, you know, 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.
About that from both.
So I'll just say I think it's as we predicted we have not heard.
Any significant.
Rumblings about it it's not something that we think is meaningfully affecting.
<unk> got to use the drug or meaningfully affecting the patient experience given that.
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.
Thank you and thanks for listening.
Please standby for our next question.
Okay.
Our next question comes from Louise Chen with Cantor. Your line is now open.
David Reisinger: And then third, could you comment on the cash burn in the quarter and remind us about your cash runway?
Hi, Thanks for taking my question for you first one I wanted to ask about was breakfast.
David Reisinger: Thank you very much.
Breakfast at Nib, and the SLE market landscape and how you think about that from your product and also why you chose this one and dramatic myositis is 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.
Matt Gline: Thanks, Dave.
<unk> studies that will 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 <unk> 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.
Matt Gline: Thank you for all those questions.
Great. Thanks, Thank you Luis all really good questions and I appreciate them all.
Matt Gline: They're all good questions, and I'm happy to take them, so I appreciate it.
So thanks for listening.
On the first on <unk>.
Right.
And Sally.
Matt Gline: You know, I'll start with the VCAMA question, which is, you know, it's early in the launch to make long-term projections on a ramp.
As you know from covering the field.
Is that.
Littered with.
Lots of people will try lots of things.
The competitive landscape, there's really there's two approved biologics with.
With lots of unresponsive patients and many others, who experienced a partial response. So it's a disease that has been historically stymied.
Bye Bye a combination of agents that haven't worked as well as they could have it that just for development.
Execution, so we see a huge opportunity for novel agents.
And.
Talked about this a little bit on our annual call and maybe some of the slides they're useful to refer to.
As Youre looking back on it but I think there is good scientific rationale for the combination of two.
And Jack one.
Being important.
Lucas.
And we've seen the restated from the crowds hitting them on the tech side.
Embarrassing him 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 Peter 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 then I.
Yes, there are no approved therapies targeting mortality and then maybe most importantly.
From a scientific perspective, we're 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.
And then even a combination of independent.
Jack one or two agents.
Might seem to be based on their data. So I'd say those are our main indication selection criteria and we think both Lucas in dermatomyositis.
Reflect that.
So that's on <unk>. Thanks, Thanks for that question.
On J T.
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 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 feels like a good read through for us.
Ultimately, they're going to publish the data.
Adam.
Look 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 in a day.
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.
And then finally physician feedback we've gotten a couple different versus discretion. This morning.
Matt Gline: All of that reads well.
Matt Gline: You know, you asked about competitive dynamics.
I'm always happy to take it because I have been incredibly pleased with the quality of the physician feedback.
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.
Look I think docs were hungry for an effective novel topical agents.
Matt Gline: So that's the first thing I'd say.
I think 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.
Matt Gline: You know, as far as the competitive landscape is concerned, yeah, I think there's a... You know, we obviously have a new topical competitor now, on the market in Zorean. It's a drug that has some nice attributes.
That outcome.
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.
We're excited to have something new to prescribe and patients are excited there is something new and nonsteroidal to go on I think 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.
Matt Gline: That said, we also think more voice share, and novel topicals for psoriasis is helpful.
Yeah.
On.
It's obviously early for us to be seeing the sort of equivalent quote limited benefit.
But early feedback that is consistent with that idea.
Matt Gline: We think there will be a little bit, of a rising tide effect overall.
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.
And so I think yes, I think it's been a really positive experience.
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.
<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.
Matt Gline: 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 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: 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 psoriasis are going to be a really big opportunity, and we think butama is going to be a really important drug, a sort of best-in-class drug in that category.
Matt Gline: So I think that'll also provide a good opportunity, for us in the marketplace.
And we think it is going to be a really really topicals in psoriasis youre going to be a really big opportunity and we think the Tam is going to be.
Matt Gline: Second on gross to net dynamics and sell side expectations.
A really important drug as sort of a best in class drug and that you see in that category. So.
Matt Gline: So, early feedback is positive, and we're excited to generate more.
Early feedback is positive and we're excited generate more of it.
Matt Gline: I guess it's a great question.
Matt Gline: Thank you.
Matt Gline: Thank you, Louise.
Thank you thank you Luiz.
Matt Gline: It's an important topic.
Operator: Please stand by for our next question.
Please standby for our next question.
Matt Gline: Just to be very clear about it, our expectation is that our gross to nets will be, our gross to net yields will be low for the next while here.
Douglas Tsao: The next question comes from Douglas Tsao with H.C. Wainwright.
The next question comes from Douglas Tsao with H C. Wainwright. Your line is now open.
Matt Gline: We've said 12 to 18 months to commercial contracts.
Douglas Tsao: Your line is now open.
Douglas Tsao: Hi, good morning.
Hi, good morning, Thanks for taking the questions just Matt maybe just as a quick follow up to Louis' question under the Tomo readout.
Japan just to confirm.
Those two studies have or that said he had the same primary endpoints as the study that you are that you are currently running in atopic dermatitis correct.
Yes.
Key secondary where Iga and <unk>, which are also.
Were also important endpoint for us exactly.
That's correct.
Yes, I just wanted to confirm does that sort of obviously highlights that the read through yes.
Should be should be very strong.
Matt Gline: You know, I think as far as, 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 that gross net yields are gonna 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.
Sure.
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 opportunities and offer app for more expensive biologics.
Matt Gline: And that's a function, we've talked about this before.
Matt Gline: It's a function of things like the new to market blocks, that make it difficult until those contracts are in place.
Yeah. Thanks, Doug I appreciate that question. It's a good one 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.
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.
Matt Gline: And then the last question on burn and runway.
It's important to have.
Matt Gline: 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 I should say visibility into about two years of runway.
And offering before biologics and I think we've said before.
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.
Matt Gline: And so I'll say we continue to run the business, with that in mind. 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 Vant portfolio, things like Data Vant 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: Yeah, 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 Dupineroff royalty financing works its way through, but I don't think that's gonna have any meaningful effect on long-term burn.
Our view on the treatment landscape is that we should be.
Mainstay of therapy.
Which is important.
Matt Gline: So thanks, Dave.
So not just a sort of a pre biologic option, but really.
As the baseline of care.
Matt Gline: That covers the three questions there.
And Thats, 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 that we want.
David Reisinger: Great, thank you.
And the second thing I would just remind people ovens.
The main thing that insurance companies care about what payers care about in determining coverage is demand.
Obviously, the scientific expertise to the product or something they look at carefully and we have 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 that 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, a price that offered us the opportunity to offer significant rebates Jewish 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 that biologics are really big pain points.
For payers right now so they're all going to be very focused on deferring that spend.
Overtime.
And then just one quick follow up I mean, how do you envision obviously getting contracts in place first of all how long do you think it will be.
When you look to add.
The atopic dermatitis indication should do you think that should be come 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 to be relatively quick on approval.
Okay, great. Thank you so much congrats on the progress thank.
Thank you.
Please standby for our next question.
Operator: Please stand by for our next question.
Dennis Ding: Our next question comes from Dennis Ding with Jefferies.
Douglas Tsao: Thanks for taking the question.
Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is now open.
Dennis Ding: Your line is now open.
Douglas Tsao: Just, Matt, maybe just as a quick follow-up to Louise's question on the Vitama readout in Japan.
Douglas Tsao: Just to confirm, the, 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?
Matt Gline: Yeah, primary and key secondary were IgA and YASI, which are also, which are also important endpoints for us.
Matt Gline: Exactly.
Yes. Good morning, two for me first on looks like your latest you mentioned that youre not seeing much of an impact but is that something you are having to educate physicians on or is that something people kind of understand.
Matt Gline: That's correct.
I understand from the get go.
And then with respect to that.
Script to accelerate what are you seeing there and how do you think that 75 dollar patient co pay or ability is impacting this alright.
Matt Gline: Yeah, I just wanted to confirm because that sort of obviously highlights that the readout, read-through should be very strong.
Douglas Tsao: 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.
Yes, so thanks.
Douglas Tsao: Because obviously, to your point, it could represent an attractive opportunity as an off-ramp for more expensive biologics.
Thanks, Brian those are both there.
Both good important questions on Folliculitis.
Dermatologists are very familiar with Follicular, just as a condition.
And that's all of them with allergists are pretty familiar with the license conditions.
Theres not a lot of education needs 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.
It's something that I think the doctor comfortable with but also the patient experience of it as mild as transient I.
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 or prescriber behavior sort of how I understand the current situation debates.
Based on the feedback that we do have.
And then so we're not.
We're not sharing specifics bill rates.
But I think.
We're extremely pleased with the overall rate.
Frictions.
And I think.
That reflects the attributes of the product that reflects the sales and 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.
And 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.
Douglas Tsao: Yeah, thanks, Doug.
Matt Gline: I appreciate that question.
Great. Thank you. Thanks.
Thanks, Karen.
Please standby for next question.
Matt Gline: It's a good one.
Our next question comes from Yaron Werber with Cowen Your line is now open.
Dennis Ding: Hi guys, thanks for taking the questions, too, for me.
Dennis Ding: First on VTLA, can you please give some more granularity on the launch in terms of who, and where it's being prescribed?
Dennis Ding: Is it, you know, are you seeing it in the mouth and moderate?
Matt Gline: Yeah, 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: 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 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.
Hi, guys. This is Brendan on for you Ron Thanks for taking my question.
Matt Gline: 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.
First is the first time to time, but I just wanted to ask about the Japanese 80 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 can we expect there.
Dennis Ding: And maybe talk about how penetrated are those accounts that you guys are currently in.
And then on requisite nib.
Dennis Ding: And then secondly, perhaps on proteovant, you know, you guys mentioned that you had, an AR degrader.
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 two study for next year given some of the competition.
And you also mentioned that your drug do you think would be potentially better than even dual administration of that Brett.
<unk> 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.
Patient populations are different only in the sense that.
The study in Japan was actually exclusively Japanese patients.
I think the read through is as positive and then just a reminder, that study is significantly smaller I think overall that study is smaller than either.
<unk> of our individual phase III studies in <unk>.
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 <unk>.
What do we think is the 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 Esri four to the approved therapies and then good data on secondary endpoints I think you did a bar for efficacy.
Reasonably high for the program.
It would be sort of one of the only oral agents. Obviously there is no currently approved oral agents. So we think we have a pretty good opportunity there.
Okay.
Thank you.
Please standby for our next question.
Yeah.
Our next question comes from.
And as Sean Gandhi with cruise Securities. Your line is now open.
Hi, this is.
Alexander.
Securities going back to the conversations with payers on a formulary position.
Have the discussions been challenged at all with the launch of <unk> is already at a price point that the competitor has chosen asset and 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 retirement in real world practice, and if you do.
Going to present this data to investors and.
What time in future might that be.
Yes. Thanks, those are those are both theft.
Good questions about the dicamba launch thank you appreciate them.
Yes.
On the <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.
No.
I don't think there is.
Real time update on the impact anyway.
I think we've talked a fair amount in our approval meeting about about.
About why we were pricing, where we were pricing in our Q. This has been guiding to their pricing strategy for some time now I think for US It was about threading the needle between.
A low enough list price to appeal to those claims that were focused on less 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.
Feel good about our pricing strategy, considering everything that went into it.
So I won't.
I can't come structure distressed strategy directly, but I feel good.
About hours I also think we just have a differentiated product from <unk> and I think the attributes of our product needs to be considered we have limited benefit.
That we've talked a fair amount about.
Their label has some.
Some features that we don't including they have drug drug interactions listed.
Chip three four metabolize drugs thats not a small thing that's.
Atorvastatin and simply statin and most contraceptives.
<unk> are included.
In their drug drug interaction profile, so I think thats 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.
<unk>.
That will also impact.
Where we are and you know I think the other thing is I would say.
When he feels and John 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 degree.
Utilization from watching the extra <unk> right I think we're.
We're happy with that and we continue to see good engagement.
And then my retirement program as well.
Overall.
It's too early to come to any long term conclusions on the refill rate or the number of <unk>, but I think.
Early data.
At this time.
Listening 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 <unk> for closing remarks.
Well great. Thank you operator, thank you for everyone for your questions. Thank you everyone for listening. This morning, and said it was a short call for that 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 may now disconnect.
Dennis Ding: Remind us what that is, and, you know, when can we expect the next one?
Matt Gline: Obviously, the scientific attributes of the product are something they look at carefully, and they have expert panels.
Matt Gline: But the way that sort of gets realized is around commercial demand.
Goodbye.
Matt Gline: And so the early script volume that we're seeing here is incredibly important, we think, in ensuring that we have the kind of credible broad coverage that we want.
Matt Gline: 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.
Matt Gline: So I think all of those dynamics are important.
Matt Gline: And we think they're going to matter.
Matt Gline: And you're absolutely right that biologics are a really big pain point for payers right now.
Matt Gline: So they're all going to be very focused on defraying that spend over time.
The conference will begin shortly to raise Johan during Q&A, you can dial star one one.
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Okay.
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Okay.
Okay.
Yes.