Q3 2024 Roivant Sciences Ltd Earnings Call

Operator: Hello, thank you for standing by. Welcome to Roivant's third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode.

Hello, Thank you for standing by walk them to avoid that third quarter 2023 earnings conference call.

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, and [inaudible] and you will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Stephanie Lee. You may begin. Good morning, and thanks for joining today's call to review Roivant's financial results for the third quarter ended December 31, 2023, along with the business update. I'm Stephanie Lee with Roivant.

After the speaker's presentation, there will be a question and answer session to ask the question. During this session you will need to press star one on your telephone.

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To withdraw your question. Please press star one again.

I would now like to hand, the conference over to Stephanie Lee you may begin.

Good morning, and thanks for joining today's call to review our financial results for the third quarter ended December 31, 23, along with the business update I'm Chuckling Lee with horizon, presenting today, we have Matt Klein CEO.

Stephanie Lee Griffin: Presenting today is Matt Gline, CEO. 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 tag numbers as we present to help you follow along.

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 Dot rugged dotcom well.

We'll also be providing the current type numbers as we present it to help you follow along I'd like to remind you that we'll be making certain forward looking statements. During today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward looking statements and related risks and uncertainties and with that I'll turn it over to Matt.

Stephanie Lee Griffin: I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt. Thank you, Steph, and thank you, everybody, for joining us today.

Thank you Stephanie and thank you everybody for joining today.

Matthew Gline: I appreciate it. It's nice to be able to talk about our third quarter results here. On slide four, just a brief overview of the agenda. So we'll talk a little bit about a recap of the last calendar year, and then we'll spend some time on the recent data coming out of Univant during the quarter, and some time talking about the upcoming proof-of-concept readout at Prepacitnib in NIU. So we've talked a fair amount about last year, and this will be the last time that we take a victory lap for it.

Appreciate that.

I appreciate it it's nice to be able to talk about our third quarter results here.

I'm on slide four just a brief overview of the agenda. So we'll talk a little bit about our recap of last calendar year and then we'll spend some time on the recent data coming out of them.

During the quarter.

Some time talking about the upcoming proof of concept readout, perhaps hit and then you will do a review of performance of the Tomo I'll highlight some upcoming catalysts in our financial update and then turn it over to Q&A. It should be a relatively short presentation today.

So we've talked a fair amount about last year and this will be the last time that we take a victory lap for it but on slide five I just want to remind everybody of the year, we're coming off of.

Matthew Gline: But on slide five, I just want to remind everybody of the year we're coming off of, during which we continue to both commercialize and, maybe even more importantly, develop V-TAMA with positive phase three data in both of our studies, setting us up for an atopic dermatitis approval that we hope will come later this year following an NDA filing that we hope will go in, an NDA filing that we hope will go in very shortly. We have the sort of full round trip of our NTTL1A antibody, which you're all quite familiar with at this point, culminating in the cell-to-roast that closed during this quarter. We generated both, at this point, proof-of-concept data, or, I should say, initial human data from IMVD-1402, showing that our next-generation anti-F serine antibody suppresses IgG, we believe, as deep as any other and without any impact on albumin or LDL and in a convenient sub-Q format.

During which we continued to both commercialized and maybe even more importantly develop the tomo with positive phase III data in both of our both of our studies.

US up for an atopic dermatitis approval that we hope will come later this year following an NDA filing that we hope will go winners NDA filing we hope will go in.

Sure.

We have.

Yeah.

Full round trip of our NTT, I Wanna antibody, which you're all quite familiar with at this point, culminating in the sale to Roche that closed during this quarter.

We generated both at this point.

Proof of concept data or not really.

Initial human data from <unk> <unk> to <unk>.

<unk> that our next generation anti F <unk> antibody suppresses ITG.

We believe as deep as any other and without any impact on albumin or LVL and a convenient sub Q format and also we've shown data from our phase II study and graves disease that meaningfully exceeded our expectations, we'll talk more about that on this call and finally, we read out PREPA sitting here of Arctic two JAK one data in <unk> this quarter as well.

Matthew Gline: And also, we've shown data from our Phase II study in Graves' disease that meaningfully exceeded our expectations. We'll talk more about that on this call. And finally, we read out brepicitinib, our TIK2JAK1 data in SLE this quarter as well. Unfortunately, it did not meet our bar or the primary endpoint, so we've just continued development in that indication and are looking forward to multiple additional readouts and programs from brepicitinib to come. I talked about this a little bit in my J.P. Morgan presentation earlier this year, but on slide 6, one thing I think we're really proud of looking back is that our model is built to develop data for important clinical programs that matter to patients in as efficient a manner as possible.

Unfortunately, it did not meet our bar or the primary endpoints and so we've just continued development in that indication and are looking forward to multiple additional readouts in programs from from representing them to come.

I talked about this a little bit.

JP Morgan presentation earlier, this year, but on slide six one.

One thing I think we're really proud of looking back is our model is built to develop data for important clinical programs that matters to patients in as efficient a manner as possible and I think if you look at our if you look at our track record here. This is a list of the largest global pharma companies.

Matthew Gline: And I think if you look at our track record here, this is a list of the largest global pharma companies, including the number of late-stage readouts they had last year and the R&D expense sort of over the period, although obviously that's not a perfect comparison. And we are very proud of the extent to which we stand out for being included on this list at all, given the amount of data we generated, and at an obviously significantly lower, generally order-of-magnitude lower cost, which just gets to the model of capital efficiency with which we bring programs in and with which we develop them, and we're excited to continue to do that with our strong capital. 2024, for us on slide seven, is really about growth and expansion.

The number of late stage Readouts they had.

Last year.

And the R&D expense.

Sort of all over the period, although obviously, that's not a perfect comparison and we are very proud of the extent to which we stand out for being included on this list at all given the amount of data, we generated and at <unk> and at a obviously significantly lower generally order of magnitude lower cost, which just gets to the model of capital.

Patiency with which we.

Which we bring programs in which we develop them and we're excited to continue to do that and our strong capital position.

2024 for us on slide seven is really about about growth and expansion.

Matthew Gline: It's about, maybe first and foremost, delivering clinical data and strategic updates for our NTF-CRN franchise. We are already making progress in laying out an aggressive, expansive development program for that franchise, and Univant provided some updates yesterday. In short, we're looking at 10 indications over the next couple of years, with four to five potentially registrational programs starting in the next fiscal year, so something that we think will help us to fully realize the value of that, we think, potentially best-in-class NTF-CRN antibody. We expect to advance clinical development for a range of underappreciated pipeline opportunities, including in brepicitinib, in damilumab, We expect to file our SNDA for vitamin atopic dermatitis shortly.

It's about maybe first and foremost.

Delivering clinical data and strategic updates for our <unk> franchise, we are already making progress in laying out an aggressive expansive development program for that franchise and reinvent provide some updates yesterday in short we're looking at 10 indications over the next couple of years with four to five potentially registrational programs starting.

In the next fiscal year. So it's something that we think will help us to fully realize the value of that.

Potentially best in class anti <unk> antibody.

We expect to advance clinical development for a range of underappreciated pipeline opportunities, including in Brexit Nib.

In the mill, a mab and in a program that's under appreciate because we haven't talked about it at all a program that we in licensed in the second half of 2023.

We expect to shortly ahead file our NDA for <unk> in atopic dermatitis, we hope to continue to accelerate revenue growth in psoriasis.

And we are really looking forward to the launch in atopic dermatitis I think has the potential to continue to change the trajectory of the program.

We know Theres a lot of focus on this next point.

This is one of the probably the best environment, we've ever seen for business development and we are actively looking at some pipeline expansion opportunities that I will just call.

Transformative.

In sort of mid to late stage development stage areas.

Matthew Gline: We hope to continue to accelerate revenue growth in psoriasis, and we are really looking forward to the launch in atopic dermatitis, which I think has the potential to continue to change the trajectory of the program. We know there's a lot of focus on this next point. This is one of the, or probably the best environment we have ever seen for business development, and we are actively looking at some pipeline expansion opportunities that I'll just call transformative in the sort of mid to late stage development stage areas. We don't have an update on specific programs to share today.

We don't have an update on specific programs to share today I can't say exactly when we will but I am enormously excited at some of the things that we have our eyes and potentially hands on and then.

We expect in the relatively near term here to finalize our capital allocation strategy across our various opportunities.

And to be able to provide significant updates.

And on slide eight when we did the deal with Roche, we ask all of you to be a little patient with us.

As we sorted through our best options for allocating what is now a $6 7 billion consolidated cash balance and we expect to use it for three things as a reminder, ensuring that robin just capitalized profitability expanding our pipeline as I mentioned on the previous slide and then.

Matthew Gline: I can't say exactly when we will, but I am enormously excited at some of the things that we have our eyes on and potentially our hands on. And then we expect in the relatively near term to finalize our capital allocation strategy across our various opportunities and to be able to provide significant updates. To that end, on slide eight, you know, when we did the deal with Roche, we asked all of you to be a little patient with us as we sorted through our best options for allocating what is now a $6.7 billion consolidated cash balance, and we expect to use it for three things. As a reminder, ensuring that Roivind has capitalized profitability, expanding our pipeline, as I mentioned on the previous slide, and then returning capital to shareholders And, you know, in short, we think that the time for patience here is coming to an end.

To return capital to shareholders and in the mountain form that makes maximal sense.

In short we think the time for patients here is coming to an end, we think we'll be able to provide meaningful updates on this in the near future and I expect this will be the last earnings call.

On which we're calling for.

Which we're calling for patients as we work things through.

We're looking forward to continuing to crystallize that plan.

Yes.

On slide nine as a reminder, we are very excited about our late stage program. It includes.

A number of drugs potential drugs that we will talk about today, including Vietnam on including the FTR and franchise with <unk>, including Brexit may have been the mill a mab.

Also includes that undisclosed phase II program.

I've mentioned, a few times here that we will definitely be providing more detail on a little bit later this year.

To highlight upfront we've told the world that we were going to develop or generate some data.

In <unk> 2001, our <unk> modulator in intrinsic independent in EMEA for low risk Mds patients I want to report that unfortunately the <unk>.

<unk> generated in that phase <unk> study did not meet our bar for progressing and so we've decided to discontinue development of <unk> 2001, after an interim analysis of that data.

Matthew Gline: We think we'll be able to provide meaningful updates on this in the near future, and I expect this will be the last earnings call on which we're calling for patience as we work things through. And, yeah, we're looking forward to continuing to crystallize that plan. On slide nine, as a reminder, we are very excited about our late-stage program. It includes a number of drugs and stencil drugs that we will talk about today, including Vitama, the FCRN franchise with batoclimab and INVTE-1402, including brepicitinib and amilamab.

Could you share some more color on it we spent a reasonable modest low double digit million sum on the program.

Sometimes these things don't work out the way you want scientifically and so we're trying to be efficient in making those decisions.

So I want to turn now to immune advance.

I mentioned before we are very focused on.

An exciting broad development strategy, there that sets up the program for maximum value across the range of strategic options. As a reminder, we are very excited about the next generation antibody <unk>, which we think offers.

Deep agg lowering similar to <unk>, we think as deep as any <unk>.

<unk> an antibody that we are aware of with a clean analyte profile with no or minimal effect on albumin or LDL.

Matthew Gline: It also includes that undisclosed Phase II program that I've mentioned a few times here that we will definitely be providing more detail on a little bit later this year. But I want to point out up front that we had told the world that we were going to develop or generate some data with RVT2001, our SF3B1 modulator in transfusion-dependent anemia for low-risk MDS patients. I want to report that, unfortunately, the data generated in that Phase I-II study did not meet our bar for progressing, and so we've decided to discontinue development of RVT2001 after an interim analysis of that data. I'm happy to share some more color on it.

Formulated for a simple subcutaneous injection designed to hopefully enable self administration.

<unk> auto injector.

And with patent life that goes out on a composition of matter basis, not excluding <unk> until 2043.

So.

Tremendously exciting drug that's against the backdrop on slide 12 of continued and growing evidence that deeper IGD suppression in general yields better clinical benefit across a variety of indications as a reminder that includes data at the patient level in myasthenia gravis showing that in individual patients those with greater.

<unk> declines had better Mg ADL improvements that.

That includes data from both our pet study, which we've made fully available and our great study, which we have not.

Matthew Gline: We spent a reasonable, modest, low double-digit million-dollar sum on the program, and I think just sometimes these things don't work out the way you want scientifically, and so we're trying to be efficient in making those decisions. Now, I want to turn now to ImmuneVant. You know, I mentioned before, we are very focused on an exciting, broad development strategy there that sets up the program for maximum value across the range of strategic options. As a reminder, we are very excited about the next generation antibody there, INVT-1402, which we think offers deep IgG lowering, similar to Batoclinab. We think it is as deep as any NTSC or an antibody that we are aware of, with a clean analyte profile with no or minimal effect on albumin or LDL, formulated for a simple subcutaneous injection designed to hopefully enable self-administration with an auto-injector, and with patent life that goes out on a composition of matter basis, not excluding PTEs until 2045.

In both of those studies, we were able to see a significantly better efficacy at our higher dose.

680 milligrams will be cocomat equivalent to 600 milligrams of <unk>.

In the ICP data generated by UCB, we saw greater IGD reduction, yielding greater platelet responses.

And Janssen.

Data put out earlier this year at J&J is already data they showed that greater IGD reduction correlated with greater auto antibody reduction, which in turn correlated with greater clinical responses. So we feel.

Very privileged that our drug has the clinical profile that it appears to.

As a reminder, on slide 13, and although it feels like a long time ago. This data wasn't degenerated in the in the third fiscal quarter for us at 600 milligrams. We show we show our data showing again that clean clean deep IGD suppression coming from both the 300 milligram and 600 milligram subcutaneous dosing over over four doses.

With that with effectively no impact as you can see on the right hand, two charts on albumin or LDL.

And we believe based on this data that we will suppress ITG to 80 plus percent.

With a full length dosing.

That came together on slide 14, as a reminder, with.

A clean safety profile with <unk>.

<unk>.

Limited and not particularly dose dependent.

Adverse events and nothing that stands out as particularly problematic so a clean profile no severe aes.

Across any armed to date, so we're pleased with that.

Matthew Gline: So a tremendously exciting drug. That's against a backdrop of continued and growing evidence that deeper IgG suppression in general yields better clinical benefit across a variety of indications. As a reminder, that includes data at the patient level in myosinia gravis showing that in individual patients, those with greater IgG declines had better MGADL improvements. That includes data from both our TED study, which we've made fully available, and our GRAVE study, which we have not. In both of those studies, we were able to see significantly better efficacy at our higher dose, 680 milligrams of batoclimab equivalent to 600 milligrams of IMVT-1402.

And then I wanted to spend a minute on graves disease.

Said, we're not talking a lot about this data because as we've pointed out anybody's phase II data is everybody's phase II data.

<unk>.

But we are excited about the <unk> opportunity you can see on slide 15. The design of that trial involves 12 weeks of dosing at 680 milligrams. The high dose and then 12 weeks of dosing and dosing of 340 milligrams the lower dose.

And these are all patients with active graves diseases reminder, who are on stable ATV prior to the stable dose of drugs prior to the screening visit and who had uncontrolled thyroid hormone levels, where hyperthyroid, despite being on Atvs and the primary endpoint with patients who achieved normalization of thyroid hormones that 12 and 24% primary.

It was 24.

Matthew Gline: In the ITP data generated by UCB, we saw greater IgG reduction yielding greater platelet responses. And in Janssen's RA data put out earlier this year, J&J's RA data, they showed that greater IgG reduction correlated with greater autoantibody reduction, which in turn correlated with greater clinical responses. So we feel very privileged that our drug has the clinical profile that it appears to. As a reminder, on slide 13, and although it feels like a long time ago, this data was indeed generated in the third fiscal quarter for us at 600 milligrams. We show our data showing again that clean, deep IgG suppression coming from both the 300 milligram and 600 milligram subcutaneous doses over four doses with effectively no impact, as you can see on the right-hand two charts for albumin or LDL.

Ideally with lower atg dose versus their baseline atg dose.

You can remember the bar that we set for that was that we wanted 50% of patients to respond.

What we've said publicly about the study on slide 16 is that we meaningfully exceeded.

That response rates.

And that we had numerically higher responses for dose tapering in ATV discontinuation in patients on the higher dose as compared with the lower dose, which we think sets us up really well to be.

Not only we believe sort of first in class and graves disease, but potentially best in class and graves disease, given our unique profile.

We continued to demonstrate significant deep acg's impressions up to approaching 90% with a mean of 81%.

And that was meaningfully greater at 680 than it was at the 300 milligram dose as expected.

And we've said, we intend to pivot development here from Tokyo, Mab, where we're really running this study as a proof of concept to <unk> 14 O. Two with plans that we will announce this year along with the overall development strategy for <unk>. So.

More to come on that opportunity.

Matthew Gline: And we believe, based on this data, that we will suppress IgG to 80 plus percent with sort of full-length dosing. That came together on slide 14, as a reminder, with a clean safety profile with limited and not particularly dose-dependent adverse events, and nothing that stands out as particularly problematic. So a clean profile, with no severe TEAs reported across any arm to date. So we're pleased with that. And then I want to just spend a minute on Graves' disease.

As we continue to build out.

Our analysis and frankly, as we continue to set ourselves up to be first.

As a reminder, on slide 17.

Now 22 indications announced or in development across the <unk> class, we get some questions about competitive intensity in very specific places from other mechanisms and the thing that is remarkable to me is the breadth of these indications is such that relative to almost any other class the competitive intensity for <unk> is surprisingly low.

Where any individual indication there might be a couple of mechanisms.

Matthew Gline: We've said we're not talking a lot about this data because, as we've pointed out, anybody's phase 2 data is everybody's phase 2 data in FCRN. But we are excited about the Graves opportunity. As you can see on slide 15, the design of that trial involves 12 weeks of dosing at 680 milligrams, the high dose, and then 12 weeks of dosing at 340 milligrams, the

Basically no other mechanism currently cuts across the full set here and we see tremendous opportunity for a broad development strategy maximizing that.

<unk> set of competitive positioning.

Across disease States.

As I said more to come on 14 or two this year, we expect some continued big unveil on.

The potentially on the strategic side and definitely on the development side.

So stay tuned and looking forward to continuing to provide those updates over the course of the coming months.

Lastly on the latest clinical pipeline just want to remind everybody on oral breath sitting here that we are.

Matthew Gline: And these are all patients with active Graves' disease, as a reminder, who are on stable ATV prior to the stable dose of antithyroid drugs prior to the screening visit and who had uncontrolled thyroid hormone levels, were hyperthyroid despite being on ATV. And the primary endpoint was patients who achieved normalization of thyroid hormones at 12 and 24, the primary was 24, ideally would lower their ATD dose versus their baseline ATD dose. And you can remember the bar that we set for that was that we wanted 50 percent of patients to respond. And what we've said publicly about the study on slide 16 is that we meaningfully exceeded that and that we had numerically higher responses for dose tapering and ATD discontinuation in patients on the higher doses compared with the lower dose, which we think sets us up really well to be not only, we believe, sort of first in class in Graves' disease We continue to demonstrate significant deep IgG suppression up to approaching 90 percent with a mean of 81 percent, and that was meaningfully greater at 680 than it was at the 340 milligram dose, as expected.

Really pushing forward our development strategy in orphan and rheumatology.

We are focused today on our what we hope will be a single Registrational study in dermatomyositis that will readout next year.

And that is enrolling nicely as well as a.

Proof of concept data coming I'll talk more about this in a second in non infectious uveitis and we continue to evaluate other possible indications, including Hs, which has obviously gotten a lot of intense attention as an indication this year and as a reminder, this drug also has quite long IP protection going out to at least 2039 inclusive of patent term extensions.

I wanted to remind everybody on the eve of the proof of concept data that we expect to generate quite soon here.

Non infectious uveitis on slide 20.

Is one of these.

Orphan inflammatory diseases.

Debilitating there are 30000, new cases of legal blindness attributed to Niu each year with.

75000, or more patients living with non interior niu.

In the U S.

The most common symptoms or sensitivity pain, redness and floaters in the vision.

And that there's really only one approved therapy, it's only humira.

And we see a.

An important unmet need given the number of patients who are progressing.

Our trial design on slide 21, it's not placebo controlled but it is a blinded to dose study between 45 and 15 milligrams randomized in favor of the 45 milligram dose.

Matthew Gline: And we've said we intend to pivot development here from Botoclamab, where we were really running this study as a proof of concept for IMVT-1402, with plans that we will announce this year, along with the overall development strategy for 1402. So more to come on that opportunity as we continue to build out our analysis and, frankly, as we continue to set ourselves up to be first.

And.

What we expect based on evidence that we haven't we have evidenced from including from our study of forgotten that demonstrated the relevance of JAK <unk> inhibition, and then IL 12 in 'twenty, three which are specifically mediated by TIK. Two were also clearly involved in the path of biology.

We are optimistic about the mechanism here and the success criteria. We've said, it's basically a sort of.

If you think about it as a virtual placebo, a 45 milligram arm treatment failure rate of no greater than 70%, which is sort of what we think the sort of placebo bar would be in an ongoing study obviously given the small number of patients we'll be looking at this data on an individual patient level.

Matthew Gline: As a reminder, on slide 17, there are now 22 indications announced during development across the NTF CRN class. You know, we get some questions about competitive intensity in various specific places from other mechanisms. And a thing that is remarkable to me is the breadth of these indications is such that, relative to almost any other class, the competitive intensity for FCRN is surprisingly low, where, you know, in any individual indication, there might be a couple of mechanisms, but basically no other mechanism currently cuts across the full set here. And we see tremendous opportunity for a broad development strategy maximizing that unique set of competitive positioning across disease states. So, as I said, more to come on 1402 this year. We expect some continued big unveils on both the potentially strategic side and definitely on the development side.

And I expect we will be sharing it as we've said in the first calendar quarter of 2024.

Enrollment of this data is that is complete so we're looking forward to getting that data in the near future.

So I want to turn quickly over to another at this point underappreciated part of our story, which is the camera.

We continue to see reason.

Reasonable script growth in psoriasis, you can see on slide 23, we remain the best selling branded topical in psoriasis as we have been since the very beginning of our launch.

And we are excited to continue to see that growth developed.

We've now had over 300000 prescriptions written by over 14000 doctors.

Our revenue continues to grow reasonably nicely, we're up to $20 7 million in net product revenue for the quarter.

Our gross to net yield has been accretive slowly and we expect roughly speaking that trend will continue over the next year.

We're now at very good payer coverage with 137 million commercial lives covered over 83% sort of the coverage that we were hoping for.

Turning to the next big opportunity here in atopic dermatitis on slide 25.

Matthew Gline: So stay tuned and looking forward to continuing to provide those updates over the course of the coming, Lastly, on the late-stage clinical pipeline, I just want to remind everybody on oral brepacitinib that we are really pushing forward our development strategy in orphan rheumatology. We are focused today on what we hope will be a single registrational study in dermatomyositis that we'll read out next year, and that is enrolling nicely, as well as proof-of-concept data coming, I'll talk more about this in a second, in non-infectious uveitis, and we continue to evaluate other possible indications, including HS, which has obviously gotten a lot of attention as an indication this year, and as a reminder, this drug also has quite long IP protection going out to at least 2039, inclusive of patent-based.

As you may have seen we read out recently.

Data from our long term extension study during three study, which is a 48 week study in atopic dermatitis, and we showed pretty remarkable data over a 50%.

Score of clear <unk>.

80% <unk> 75 improvement.

And just just some great data overall here that puts us frankly.

Not only at the head of the pack in our view from a tactical perspective, but in line frankly with the efficacy of some systemic therapies in these populations. So.

A really tremendous set of data here.

<unk>.

It continues to support what we think is a really big opportunity and <unk>.

And notably.

Continue to have a clean safety profile with <unk>.

Mild to moderate aes, nothing sort of remarkable in a very low discontinuation rate due to adverse events.

We expect to as I said file the NDA in atopic dermatitis shortly.

Matthew Gline: I want to just remind everybody, on the eve of the proof of concept data that we expect to generate quite soon here on non-infectious uveitis, on slide 20, you know, this is one of these orphan inflammatory diseases that is debilitating. There are 30,000 new cases of legal blindness attributed to NIU each year, with 75,000 or more patients living with non-interior NIU in the U.S. The most common symptoms are sensitivity, pain, redness, and floaters in the vision.

And that will set us up for a potential approval later this year.

That needs to be said again, atopic dermatitis is a large and growing market with close to 350000 topical prescriptions written every week the vast majority of them corticosteroids and where the real opportunity, we think towards the camera to shape that field as a drug with efficacy at the head of the pack from Ey.

From an atopic dermatitis sort of overall perspective, and with the safety and Tolerability profile that we think further differentiate.

Some of our competitors, so a really exciting opportunity and notably our next fiscal year, we will have a quarter of sales.

Matthew Gline: And there's really only one approved therapy, it's only Humira, and we see an important unmet need given the number of patients who are progressing. Our trial design, on slide 21, is not placebo controlled, but it is a blinded two-dose study between 45 and 15 milligrams, randomized in favor of the 45 milligram dose.

Hopefully some data on script volume in atopic dermatitis, so really looking forward to getting out there in that sort of full breadth of the patient population.

<unk>.

Rounding out the year on slide 28.

We've talked about some of the opportunities here, but we have a lot of interest in clinical data coming.

Matthew Gline: And what we expect based on the evidence that we have, and we have evidence from, including a study of Fogotinib that demonstrated the relevance of JAK1 inhibition, and then IL-12 and 23, which are specifically mediated by TIK2, are also clearly involved in the pathobiology. So we're optimistic about the mechanism here. And the success criteria we've set is basically a sort of, if you think of it as a virtual placebo, a 45 milligram arm treatment failure rate of no greater than 70%, which is sort of what we think the sort of placebo bar would be in an ongoing study. Obviously, given the small number of patients, we'll be looking at this data at an individual patient level. And I expect we'll be sharing it, as we've said, in the first calendar quarter of 2024 once the enrollment of this data is complete.

Obviously, niu we've talked about.

You've talked about some of the upcoming <unk> data, but notably this year, we're going to develop.

Phase II data in <unk> that should help to start establishing deep agg's depression potentially as mattering in more disease are the same thing with our.

A phase III program in myasthenia gravis, where we expect to begin getting data.

At the end of this year again.

Setting us up for some real potential including.

First simple sub Q2 readout phase III data in that indication and then we're also going to get data. This year from <unk>, our anti GM CSF antibody in sarcoidosis, a program that we think gets no value attributed to it today, but which we think has the potential to be very important in the event of successful data.

Yes.

On the financials on slide 30.

Net revenues for the quarter of $37, one, including the kind of product revenue of 27.

R&D expense of 120 about million dollars adjusted non-GAAP of about 115.

<unk> of about $200 million of adjusted of about $1 50.

Matthew Gline: So we're looking forward to getting that data in the near future. So I want to turn quickly over to another, at this point, underappreciated part of our story, which is VITAMA. We continue to see reasonable script growth in psoriasis. You can see that on slide 23.

And it's something I don't know that I'll be able to report in the near future again net income of $5 1 billion.

Which is there is a number obviously related to the closing of the of the Roche deal, leaving us with cash and cash equivalents.

$6 $7 billion as of the end of the year.

<unk>, we're very excited with that.

So with that I'll close just by asking to flash up slide 32, and note that we have quite a rich quite a rich set of catalysts coming and more to come as we continue to build out.

Matthew Gline: We remain the best-selling branded topical in psoriasis, as we have been since the very beginning of our launch, and we are excited to continue to see that growth develop. We've now had over 300,000 prescriptions written by over 14,000 doctors. Our revenue continues to grow reasonably nicely. We're up to $20.7 million in net product revenue for the quarter. Our risk-to-net yield has been accreting slowly, and we expect, roughly speaking, that trend will continue over the next year. And we're now at very good payer coverage, with 137 million commercial lives covered, over 83 percent, sort of the coverage that we were hoping for. Turning to the next big opportunity here in atopic dermatitis on slide 25, as you may have seen, we read out recently data from our long-term extension study, the ADORING3 study, which is a 48-week study in atopic dermatitis, and we showed pretty remarkable data, over a 50 percent IgA score of clear, an 80 percent ED75 improvement, and just some great data overall here that puts us, frankly, not only at the head of the pack, in our view, from a topical perspective, but in line, frankly, with the efficacy of some systemic therapies in these populations.

And talk more about parts of our pipeline that were.

We're excited about what haven't unveiled publicly yet so with that I will wrap up the presentation here.

And thank you to everybody for listening I will turn it over to the operator for Q&A.

Thank you.

Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and then wait to hear your name announce to withdraw your question. Please press star one again please.

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

Our first question comes from the line of Allison, Brett <unk> with Piper Sandler Your line is open.

Hey, good morning, and thanks for taking my question.

So Matt I think I heard your characterization of the current setup as a it's very conducive to BD.

And how you see pipeline expansion opportunities that are transformative I guess could you maybe set some guardrails on your current thinking on Bebe transformative makes it sound like Youre looking at a single versus multiple.

<unk>, but not from a you know until pretty not that correctly and then I think I'll see you I heard you say, we should have an update on the capital allocation strategy before the next earnings apart could you just help us understand kind of what's gating to that disclosure and and how you expect to communicate that to the street. Thanks.

So on the first question I'm glad you asked it and I'll ask Mike to chime in as well, but we think it's important.

Matthew Gline: So, a really tremendous set of data here that continues to support what we think is a really big opportunity in AD, and notably, continue to have a clean safety profile with mild to moderate AEs, nothing sort of remarkable, and a very low discontinuation rate due to adverse events. You know, we expect to, as I said, file the SNDA in atopic dermatitis shortly, and that'll set us up for a potential approval later this year. It needs to be said again, atopic dermatitis is a large and growing market, with close to 350,000 topical prescriptions written every week, the vast majority of them corticosteroids, and with a real opportunity, we think, for Vitama to shape that field as a drug with efficacy at the head of the pack from an atopic dermatitis sort of overall perspective, and with a safety and tolerability profile that we think further differentiates from some of our competitors.

The general sort of scope of things, we're looking at I'd say match the kinds of deals that we've done before so partnerships or acquisitions of late stage programs generally more likely I would say to be programs than M&A I'd say.

Potentially multiple.

Over the next year, including including some of the ones we've already done.

And when I say transformative what I mean by that is I think these will be programs at least some of them.

Going into.

Large late stage studies of a kind of it will change the shape of our pipeline.

And add meaningful heft to what we think is already a pretty great late stage effort, Mike anything you'd add to that.

Sorry, maybe you might be on mute.

Yeah.

Okay.

If not I'll go to the other question, but thanks.

Thanks for asking that question. It's a good question and it's important that we be clearer on what we're looking at there because then it's less likely to be either frankly, it's less likely to be sort of M&A per say never say never but less likely.

And potentially not going to be a single program, maybe multiple and then on the capital allocation point. So yeah look I think certainly by the time of our next earnings call I expect to have made some meaningful progress here.

Matthew Gline: So, a really exciting opportunity, and notably, in our next fiscal year, we will have a quarter of sales and, hopefully, some data on script volume in atopic dermatitis. So, really looking forward to getting out there in that sort of full breadth of the patient population. Rounding out the year on slide 28.

So if I say this is not just about.

Analysis.

This is a combination of frankly advancing some of these late stage business development conversations, but we have a sense of the exact breath of the sort of BD piece of this although I think it's hard to imagine that that combination of things is going to sort of.

Meaningful.

Matthew Gline: You know, we've talked about some of the opportunities here, but we have a lot of interesting clinical data coming. Obviously, NIU, we've talked about, we've talked about some of the upcoming FCRN data, but notably this year, we're going to develop Phase 2B data and CIDP in batoclimab that should help to start establishing deep IgG suppression, potentially as a matter of matter in Same thing with our Phase 3 program in myasthenia gravis, where we expect to begin getting data at the end of this year. Again, setting us up for some real potential, including the first simple sub-Q to read out Phase 3 data and that indication. And then we're also going to get data this year from namilumab, our anti-GMCF antibody, and sarcoidosis, a program that we think gets no value attributed to it today but which we think has the potential to be very important in the event of successful data.

Change the total picture.

And then also look I think part of what we've talked about from a capital return perspective is the concentration of our shareholder base and.

Sumitomo for example has indicated.

Desire to exit their position given their own financial considerations.

As you can imagine.

Ongoing discussions with all of our shareholders and I think we're trying to.

Progress those in the optimal way for setting us up for success. So I think all of that is what is ongoing.

Once that resolves we should be able to provide.

More clarity.

Okay very helpful. Thank you.

Thank you.

Please standby for our next question.

Our next question comes from the line of David Risinger with Leerink Partners. Your line is open.

Yes, thanks, very much and thank you for all the updates Matt. So could you. Please discuss both the Madonna LNP litigation event path ahead, and also Pfizer LNP litigation developments to watch I know that you're limited with respect.

What you can say, but.

Whatever you can provide on the call would be helpful. And then Richard could you discuss the spend.

Matthew Gline: You know, on the financials on slide 30, net revenues for the quarter of 37.1, including the account product revenue of 20.7, R&D expense of 120, about $1 million, adjusted non-GAAP of 115, SG&A of about $200 million, or adjusted of about $150, and something I don't know that I'll be able to report in the near future again, net income of $5.1 billion, which is a number obviously related to the closing of the of the Roche deal, leaving us with cash and cash equivalents of $6.7 billion as of the end of the year, a position we're very excited.

On 224, specifically.

SG&A and R&D, thanks very much.

Thanks, Dave I appreciate the questions as always I appreciate that you are.

Put the caveat out there for me about my.

Limited ability to comment here.

I think on the maternal litigation one thing I can say because it's obviously public information is so we had our markman claim construction hearing last week.

I think overall I will say, we were pleased with our ability to make the arguments that we thought were important to us.

It's an important hearing we think that the judge is going to do a good job of considering considering everything everyone brought to the table. So we'll know more about the outcome for that I think.

Operator: So, with that, I'll close just by asking you to flash up slide 32 and note that we have quite a rich set of catalysts coming and more to come as we continue to build out and talk more about parts of our pipeline that we're excited about but haven't unveiled publicly yet. So, with that, I will wrap up the presentation here, and I would thank everybody for listening. I will turn it over to the operator for Q&A. Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 again.

The judge has said previously sort of 60 ish days. There is no set timeline for that response. So I think we're looking for it in about that time frame, but it's a complicated set of issues and we want to make sure.

Everything's gets properly evaluate and so that's an extra two significant events.

On the <unk> side.

On the Pfizer side that.

That cases ongoing there is no set dates for a markman hearing, but we would expect it to take place sometime later this year.

So.

That's all that's all ongoing and appreciate our we know that a number of people are following along there.

On the cash side I'll turn it over to Richard as you suggested but I'll. Just say you know I think there's sort of puts and takes you're obviously <unk> is out of the spend.

Allison Marie Bratzel: Please stand by while we compile the Q&A roster. Our first question comes from the line of Allison Bratzel with Piper Sandler. Your line is open.

Matthew Gline: Hey, good morning, and thanks for taking the question. So, Matt, I think I heard your characterization of the current setup as very conducive to BD and how you see, you know, pipeline expansion opportunities that are transformative. I guess, could you maybe set some guardrails on your current thinking on BD? You know, transformative makes it sound like you're looking at a single versus multiple opportunities, but I'm not sure I'm interpreting that correctly.

Tamara continues to ramp which is which is mostly helpful from a from a cash burn perspective, but some of it also depends on programs that we either have or will bring in but Richard any any comments that you want to make on on spend for the next year.

I would anticipate that spend would be relatively thought over the next few quarters, obviously want.

<unk> approval comes through on <unk> towards the end of the year, we would ramp up the sales efforts there. So youll see an uptick as we approach that towards the end of the year and then also as the <unk> to R&D spend ramps up with the additional trials that we talked about that will also start coming through but.

Matthew Gline: And then I think also, I heard you say we should have an update on the capital allocation strategy before the next earnings report. Could you just help us understand kind of what's gating that disclosure and how you expect to communicate that to the street? Thanks.

Relatively flat over the next few quarters and then see a.

Our amp up as more trials comes through also we will see some data on <unk>. So we'll have to make a decision there.

If we do additional spending depending on how that data reads out.

And then asarco notes at the end of the year as well.

Matthew Gline: Yes. So, on the first question, I'm glad you asked it, and I'll ask Mayukh to chime in as well, because I think it's important. The general sort of scope of things we're looking at, I'd say, matches the kinds of deals that we've done before. So, partnerships or acquisitions of late stage programs are generally more likely, I would say, to be programs than M&A. I'd say potentially multiple over the next year, including some of the ones we've already done. And, you know, when I say transformative, what I mean is, you know, I think these will be programs, at least some of them, going into large late-stage studies of the kind that will change the shape of our pipeline and add meaningful heft to what we think is already a pretty great late-stage effort. Mayukh, anything you'd add to that? Sorry, you might be on.

Great. Thank you.

Thank you Dave.

Please standby for our next question.

Our next question comes from the line of Brian Chin with J P. Morgan Your line is open.

Hey, guys. Thanks for taking my questions. This morning.

Matt The last earnings call, we didn't touch on the asset that you acquired I mean, whats reflect at 14 million item in the in process R&D buying in the 10-Q.

Can you give us more color here on this stage of the <unk>.

<unk>, how much data there behind that program and when can we see the next data update here.

I have a quick follow up thank you.

Sure Yeah. So.

On the unnamed asset.

So we've now provided a little bit more color. We've indicated that the program should be entering phase III. So that should give you a sense on stage.

I won't say too much more.

Where we feel like we have a reasonably decent handle on whats going on but it is a it's a development program.

And the reason, we're not talking very much about it right now is it's roughly a competitive space and we think we have an opportunity to be heard.

Matthew Gline: Okay, if not, I'll go to the other question. But thanks for asking that question. It's a good question.

So we'll talk more about it later this year as the clinical program gets up and running.

And.

Matthew Gline: And it's important that we be clear on what we're looking at there, because I think it's less likely to be either, frankly; it's less likely to be sort of M&A per se, never say never, but less likely, and potentially not going to be a single program, maybe multiple. And then on the capital allocation point, so, you know, look, I think certainly by the time of our next earnings call, I expect to have made some meaningful progress here. You know, I might say this is not just about analysis. And this is a combination of frankly advancing some of these late-stage business development conversations so that we have a sense of the exact breadth of the sort of DD piece of this.

So I think that was that was your main question. There and then if you had another one.

And related to immuno and plan here, it's quite a robust development plan for the next one to two fiscal year.

Peter you are shooting for or do you see the need for Atlantic partner off or do you think that they can lean on broadband for additional financial resources.

Yeah. Thanks, Brian that's a it's a very good question look I think as we think about sort of the combination of <unk> and immune event. There was certainly no.

Financial need.

For our partner per Se.

And I think the plan that we've laid out here wallets.

While it is aggressive and while its broad we've chosen it in part because we believe we are capable of the clinical execution.

With a program of this breadth of opportunity I think we are certainly able.

Between roving in immune event and with the full use of resources that either that are needed.

Matthew Gline: Although I think it's hard to imagine that that combination of things is going to sort of meaningfully change the total picture. And then also, look, I think part of what we've talked about from a capital return perspective is the concentration of our shareholder base. And, you know, Sumitomo, for example, has indicated a desire to exit its position, given its own financial considerations.

To do something big and important here and I think there.

There are few things going on it really isn't that are more important than the successful development of 14 or two so if a unit that would benefit from resources either people or financial you can bet that we'll be having those conversations.

Yes.

Although the elected the competitive intensity is comparatively low it's obviously a competitive space and we have some well funded and strong operationally competitors. We think we can keep pace with any of them on clinical development, but certainly as we've said before we're going to be ruthlessly economics, and maximizing the value of the program including.

Matthew Gline: You know, we, as you can imagine, have ongoing discussions with all of our shareholders. And I think we're trying to sort of progress those in the optimal way for setting us up for success. So, I think all of that is ongoing. And once that resolves, we should be able to provide more clarity. Okay, very helpful.

Thinking about partnership and other strategic opportunities for immune event to make sure we arent missing a beat.

Great. Thank you.

Thank you Brian Thanks for listening.

Matthew Gline: Thank you. Please stand by for our next question. Our next question comes from the line of David Risinger with Lirik Partners. Your line is open.

Please standby for our next question.

Our next question comes from the line of Yamana Weber with TD Cowen Your line is open.

David Reed Risinger: Yes, thanks very much. And thank you for all the updates, Matt. So could you please discuss both the Moderna LNP litigation event path ahead and also Pfizer LNP litigation developments to watch? I know that you're limited with respect to what you can say, but you know, whatever you can provide on the call would be helpful.

Good morning. This is Joey on for Ron Thanks for taking our questions.

Now that the lupus study is right out what's your latest thinking on which indications to prioritize for partners to an event.

When might we hear more about that broader indication list. Thanks.

Yes. Thank you. Thanks for thanks for listening and thanks for the good question and we're very excited about representative I will potentially asking you to comment a little bit on this too.

I think.

This is the first earnings call we've had since the reps into glucose data, yes, I don't think we read much of anything into the program at all from the lupus readout, we'd always sort of indicated we thought it was going to be a high risk readout.

Matthew Gline: And then, Richard, could you discuss the spend, 2024, specifically, you know, SG&A and R&D. Thanks very much. Thank you, Dave. I appreciate the questions, as always. I appreciate that you put the caveat out there for me about my limited ability to comment here. You know, I think about the Moderna litigation. One thing I can say, because it's obviously public information, is that we had our Markman or claim construction hearing last week. You know, I think overall, I'll say that we were pleased with our ability to make the arguments that we thought were important to us. And it's an important hearing; we think that the judge is going to do a good job of considering everything everyone brought to the table. So we'll know more about the outcome for that. I think the judge has said previously, sort of 60-ish days; there's no set timeline for that response.

Because of lupus disease dynamics, and frankly, the drug effect in the study was reasonable or in fact quite good. The problem was we saw as we've indicated the largest placebo response rate I think ever observed in SLE study and so I don't think that gets particularly to the opportunity for the drug and then the safety profile remains consistent with what we've observed historically, so I think there is.

The answer is we are full speed ahead on our original plan that centers around dermatomyositis, where the study continues to enroll wealth that includes potentially Niu, obviously is as Richard said and as I said earlier.

To make a decision on what to do with Niu after observing that proof of concept data coming in the near future.

Then.

Other indications, we continue to evaluate a reasonable breadth of indications that sort of fit in that call. It orphan rheumatology bucket, but.

I'd say one that we.

Or sort of making a decision on in the relatively near future potentially.

Matthew Gline: So, you know, I think we're looking for it in about that timeframe, but it's a complicated set of issues, and we want to make sure everything gets properly evaluated. So that's the next sort of significant event on the Moderna side. On the Pfizer side, that case is ongoing. There's no set date for a markman hearing, but we would expect it to take place sometime later this year.

Depending on what we see in Niu, etc.

Is hs, where we have quite good phase II data so so.

Things that fit nicely with that are still on the list for us, but we are first and foremost focused on.

On DM and then Niu.

Thank you. Thank you for your great questions.

Please standby for our next question.

Yeah.

Our next question comes from the line of Dennis staying with Jefferies. Your line is open.

Hi, good morning, Thanks for taking my questions two for me so.

Regarding <unk> can you. Please clarify your previous comments you said not a single program for multiple multiple programs with us all come from a single announcements or is this more like us.

Matthew Gline: ......

Matthew Gline: So that's all ongoing, and I appreciate, we know that a number of people are following along there. On the cash side, I'll turn it over to Richard as you suggested, but I'll just say, you know, I think there's sort of a puts and takes here. Obviously, TL1A is out of the spend.

Pearls type of BD path over the next year.

And then question number two around immuno Matt.

Has the company engaged with the FDA yet.

On a registrational path for <unk> and the level of confidence that 2014 O. Two can go directly to phase III and skip the phase two thank you.

Matthew Gline: VTAMA continues to ramp up, mostly helpful from a cash burn perspective, but some of it also depends on programs that we either have or we'll bring in. But Richard, any comments that you want to make on spend for the next year? Yeah, I would anticipate that spend would be relatively flat over the next few quarters.

I think I'll take the second question first and then I'll briefly comment on the first and I'll see if my.

At this time around his comments on the video question as well.

On.

I think the main answer to that question is.

We're going to leave it to immune event to make the exact announcements of the clinical plan for fortino too, but I think we're.

Richard Pulik: Obviously, once AD approval comes through on VTAM towards the end of the year, we would ramp up the sales efforts there. So you'd see an uptick as we approach that towards the end of the year. And then also as the 1402 R&D spend ramps up with the additional trials that we talked about, that will also start coming through, but relatively flat over the next few quarters and then see a ramp up as more trials come through. Also, we will see some data on NIU. So we'll have to make a decision there to see if we do additional spending depending on how that data reads out, and then start to dose at the end of the year as well. Great, thank you.

Working through with <unk>.

And otherwise all of the important regulatory questions and I think we are.

Immune advanced guidance that Theyre able to go into a four to five.

Registrational programs. This year is certainly.

An informed view of what theyre going to be able to accomplish so I think we're we're feeling good there, but we'll provide specific updates on any given indication.

As and when we've got them on the BD side again. Thanks for thanks for the question. It's a great question. It's important clarification. This is not like we're working on a single large package deal with multiple thing because this is just we see quite a lot out there that we're excited about.

So we've already got the one in house and we've got a couple of other things that works.

On a racket I'd say, so I think it's more of a I think you called it a string of pearls I think it's more of a we see multiple programs and will bring.

Several things in over the next year and frankly beyond right. It's sort of just how we've always run our business but.

I hope you're able to comment on that yes, you've got Permian right yes.

Matthew Gline: Please stand by for our next question. Our next question comes from the line of Brian Chen with J.P. Morgan. Your line is open.

Yeah, Yeah, that's right I think you hit the main point right at the end there I mean look this is sort of regular regular course for us we're always looking for promising assets, where we think we can make a difference.

Louise Alesandra Chen: Hey guys, thanks for taking my questions this morning. Matt, on the last earnings call, we didn't touch on the asset that you acquired, and it was reflected as the $14 million item in the process R&D line of 10Q. Can you give us more color here on the stage of the asset indication? How much data was there behind this program?

We are as focused on that as we've ever been and we're not resting we're working hard towards it the exact timing and sort of contours of that.

Still still sort of unknown, but.

I expect that expect to hear more from us.

Got it. Thank you that's very helpful and I can just squeeze one last question here I know you can enter.

Matthew Gline: And when will we see the next data update here? I have a quick follow-up. Thank you. Sure, yep.

The patient is coming up soon maybe.

You can comment on what's the bar for success here given it's a small study and there is no placebo I know theres some numbers in your slides around expecting less than 30% failure rate and youre estimating 80%, 90% stimulated placebo, but just wondering if you may actually need to see a lower failure rates since placebo.

Matthew Gline: So on the unnamed asset, on the unnamed asset, on the unnamed asset, on the unnamed asset. We've now provided a little bit more color. We've indicated that the program should be entering phase two, so that should give you a sense of where we are. I won't say too much more.

OCA Humira and forgotten the placebo can be highly variable. Thank you.

Matthew Gline: It's in a space where we feel like we have a reasonably decent handle on what's going on, but it's a development stage program. [inaudible] [inaudible] So I think that was your main question there, right? And I think you had another one. Yeah, and related to Yiminowen's plan here, it's quite a robust development plan for the next one to two fiscal years. With the speed that you're shooting for, do you see the need for Yiminowen to partner off?

Yes. Thanks.

So I'll hand it over.

Sort of our thoughts on that question.

Okay.

If not I can take it he might be on mute, yes, no Ahmad.

So they go.

No I don't have too much.

Too much there I mean, I think look I think you both.

Pointed out that there is some variability there, but I think the what I think we're looking at this in the same way that we look at all of our trials, we want to see for ourselves.

<unk> sort of clear.

A clear signal of efficacy I think even accounting for some potential variability in sort of notional placebo rate and we'll be excited to move forward. If it's if it's clear.

Matthew Gline: Or do you think that they can lean on Roivant for additional financial resources? Yeah, thanks, Brian. That's a, it's a very good question. Look, I think, as we think about sort of the combination of Roivant and Immunovant, there is certainly no financial need for a partner, per se.

The only other thing I'd add is this is a it's a 24 patient study.

It's randomized in favor of the 45 milligram arm.

My experience our experience looking at phase II data.

As you sort of expect it to be like.

You hit F. Nine on the computer and you get a green thumbs up thumbs down and usually what you get.

You know like a greenish triangle or something like that and you're like what does that mean.

Matthew Gline: And I think the plan that we've laid out here, while it's aggressive and while it's broad, we've chosen it in part because we believe we are capable of clinical execution. So, you know, with a program of this breadth of opportunity, I think we are certainly able, between Roivant and Immunovant, and with the full use of resources at either that are needed to do something big and important here. And I think there are a few things going on at Roivant that are more important than the successful development of 1402. So, if Immunovant would benefit from Roivant resources, either people or finances, you can bet that we'll be having those conversations. That said, although I said the competitive intensity is comparatively low, it's obviously a competitive space, and we have some well-funded and strong operational competitors. We think we can keep pace with any of them on clinical development, but certainly, as we've said before, we're going to be ruthlessly efficient in maximizing the value of the program, including thinking about partnership and other strategic opportunities for Immunovant to make sure we aren't missing Great. Thank you, Matt.

I think you can imagine it's hard to reduce the extra data that we're going to get from the study into a single number.

Set that bar over 70% treatment failure rate biased. Thank you can you can because we're going to be looking at every patient and trying to make sure. We understand what the drug is doing and these are these are quite sick patients again 30000, new cases of blindness every year or so.

It's something where we feel like we have an opportunity to make a big difference with the right clinical picture.

There are two other points to add there I think.

Look we are sort of hoping to see.

A bit of a dose response here in that like while there is not a placebo. There is a relatively low dose of PREPA that ought to give a little bit of a let's just call. It maybe not placebo, but something kind of closer to placebo on efficacy and the 50 milligram dose that's thing one and thing too is I think at least in conceptualizing the humor.

Sarah.

Sort of comp that you that you cited.

More aggressive steroid taper in our study than in the Humira study.

And so you'd expect to see.

A higher placebo failure rate as a result.

Okay. Thank you.

Thanks Dennis.

Please standby for our next question.

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

Matthew Gline: Thank you, Brian. Thanks for listening. Please stand by for our next question. Our next question comes from the line of Yaron Werber with TD Cohen. Your line is open. Hey guys, good morning. This is Joya Phan for your own.

Hi, Thanks for taking my question here.

First on how you plan to address the concentration in the shareholder base will that kind of all be done together with some of the announcements that you plan to make up for the next earnings call.

Matthew Gline: Thanks for taking our questions. Now that the loop of study is read out, what's your latest thinking on which indications to prioritize for breprositinib, and when might we hear more about that wider group? Yeah, thank you.

And then the second thing I wanted to ask you was an expansion in your pipeline what therapeutic areas are most interested in and if you can't say what therapeutic areas you're most interested in how competitive do you want to get with some of the most topical areas that people are investing in right now thank you.

Matthew Gline: Thanks for listening. And thanks for the good question. And we're very excited about representing them.

Yeah. Thanks, Louise Thanks for listening and those were both those are both really good questions on the shareholder base side I think the first answer is that is not a decision that we can make unilaterally.

Matthew Gline: I will potentially ask Mayukh to comment a little bit on this, too. You know, I think this is the first earnings call we've had since the release of the brevastatin of lupus data. You know, I don't think we read much of anything into the program at all from the lupus readout. We had always sort of indicated that we thought it was going to be a high-risk readout because of lupus disease dynamics. And frankly, the drug effect in the study was reasonable, or, in fact, quite good. The problem was, as we've indicated, the largest placebo response rate I think I've ever observed in an SLE study. And so, you know, I don't think that relates particularly to the opportunity for the drug. And then the safety profile remained consistent with what we've observed historically.

Our desires, but also the desires of some of our concentrated shareholders who.

In many cases are.

Happy holders and frankly believe.

I believe what we believe which is that our stock is meaningfully undervalued given the.

Sort of overall position of the company. So I think that's a <unk>.

A discussion we have to have sort of bilaterally with each of them.

And.

We'll take it in turn I think.

What would you expect to do is to be.

Ruthlessly economic and thoughtful about how we use our cash for that purpose.

No.

Whether that means we can clean them up but once weather women's we clean some of them up I think that depends a little bit on.

On their needs and their appetite and.

I'm, making the right economic decisions so.

Stay tuned is the short answer.

Matthew Gline: So, I think the short answer is we are full speed ahead on our original plan. That centers around dermatomyositis, where the study continues to enroll well. And that includes potentially NIU.

On the BD question, and again I'll ask Mike because he his comments as well, but I think the short answer is we are sort of necessarily agnostic to therapeutic area. Because so much of our opportunity comes from strategic shifts and focus at our partners in that leading them to need to.

Matthew Gline: Obviously, as Richard said and as I said earlier, we'll have to make a decision on what to do in NIU after observing that proof of concept data coming in the near future. And then, you know, other indications. We continue to evaluate a reasonable breadth of indications that sort of fit in that, call it, orphan rheumatology bucket. But I'd say one that we are sort of making a decision on in the relatively near future, potentially depending on what we see in NIU, et cetera, is HS, where we have quite good phase 2 data. So, I think things that fit nicely with that are still on the list for us, but we're first and foremost focused on DM and then NIU. Thank you for the great questions.

We think their portfolio. So if someone is doubling down on immunology maybe.

Nothing else is falling out as a consequence, so it's I think we're pretty flexible.

In general because.

Because we're in that sort of a string of pearls one program from here one program from their dynamic.

What that tends to mean is we are more excited about areas, where a single program can kind of stand on its own.

So I think of the immunology programs that we've developed for example.

And maybe a little bit less excited about areas, where you need a concentration either because it's like oncology, where you're developing multiple drugs in combination in order to have a coherent plan or maybe because its something like cell and gene therapy, where you have a sort of a need for manufacturing expertise that provides an economy of scale. So it's not that we would not go.

Matthew Gline: Please stand by for our next question. Our next question comes from the line of Dennis Ding with Jeffrey. See, your line is open. Hi, good morning, and thanks for taking our questions. Two for me.

Do either of those areas, but they're probably like modestly less likely for that reason.

Mike anything you'd add to that.

Yes, I think as we look and this is really typical of the history of the company I think as I kind of look at that.

Unknown Attendee: So regarding BD, can you please clarify your previous comments? You said not a single program but multiple, multiple programs. Will this all come from a single announcement? Or is this more like a string of pearls type of BD path over the next year? And then question number two around immunoband.

The list of things that I would say that we're excited about and prosecute pursuing right now.

Eclectic a list is wanting to kind of kind of imagine in terms of therapeutic area. So as Matt said, we're going to continue to be therapy area agnostic.

Matthew Gline: Has the company engaged with the FDA yet on a registrational path for grades and the level of confidence that 1402 can go directly to? Thank you. Thank you. I'll take the second question first, and then I'll briefly comment on the first, and I'll see if Mayukh, this time around, has comments on the BD question as well.

I think that we have tended as for the reasons that Matt stated, we have tended to be in areas that probably at first glance tend to be a little bit off the run or a little bit of contrarian and sometimes.

I think we've shown that.

Sometimes those areas tend to heat up.

We have sort of seen with.

Matthew Gline: You know, on ImmuneVant, I think the main answer to that question is we're going to leave it to ImmuneVant to make the exact announcements about the clinical plan for 14-02, but I think we're working through with FDA and otherwise all the important regulatory questions. And I think we are, you know, ImmuneVant's guidance that they're able to go into four to five potentially registrational programs this year is certainly an informed view of what they're going to be able to accomplish. So I think we're feeling good there, but we'll provide specific updates on any given indication as and when we've got them. Clarification

With CRM and then with <unk> in the past and so that could that could well happen again.

But probably again just a mix.

I think if anything I'd tell you is yes.

No no go ahead, Matt.

The bar for US is not is it competitive the bar for US is can we get something that makes sense for us given the development plan, the economic terms et cetera, and so there are occasionally programs in very competitive spaces, where idiosyncratic factors makes them competitive from a sort of like.

Many people care about it perspective, but are nonetheless easy for us to get and then there are sometimes programs in less competitive areas. Nonetheless, they're part of the probably loose and so I think it is not about sort of how many other people are doing it it's about what we can get our hands on.

Thanks Louise.

Thank you.

Please standby for our next question.

Matthew Gline: You know, this is not like we're working on a single large package deal of multiple things. This is just that we see quite a lot out there that we're excited about. So we've already got the one in-house, and we've got a couple of other things that were, you know, on our racket, I'd say. So I think it's more of a, I think you called it, a string of pearls.

Yeah.

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

Yeah, Hey, good morning, maybe as a follow ons Olivia's question how.

How do you think about right and ability to add value to the assets that you are considering in those deals and what do you view as the company's core competencies in that context, and then I was also wondering you say that the environment is sort of.

Matthew Gline: I think it's more of a, we see multiple programs, and we'll bring potentially several things in over the next year and, frankly, beyond, right? It's sort of just how we've always run our business. But Mayukh, yeah, there you go.

Really good shape, it's ever been but what metrics are you seeing that inform that comment and as the biotech market kind of has and hopefully will continue to improve how do you expect the environment to shake out from here.

Yeah. Thanks trend those are both really good questions.

Matthew Gline: Yep, yep, yep. Loud and clear. Yeah, that's right. I think you hit the main point right at the end there. I mean, look, this is sort of a regular, regular course for us.

On the first I think it is.

Unquestionably the case, but the thing we have done most in our history and best in our history is creative thoughtful aggressive clinical development.

We've run 10 positive phase III studies.

Mayukh Sukhatme: We're always looking for promising assets where we think we can make a difference. And we're as focused on that as we've ever been. We're not resting.

We've run many many phase III studies, we've changed indication plans for programs, where we thought that made sense. We've done we think quite good job at late stage development for programs that.

Matthew Gline: We're working hard towards it. The exact timing and sort of contours of that, you know, are still sort of unknown. But, you know, expect to hear more from us.

We were happy with the choice of indication so I think.

First and foremost I think value we add when we look at our new program I think the ability to be.

Thoughtful and creative.

Unknown Attendee: Thank you. That's very helpful. And I can just squeeze one last question here around NIU, given the FACI data is coming up soon. Maybe you can comment on what's the bar for success here, given it's a small study and there's no placebo. I know there's some numbers in your slides around expecting, you know, less than 30% trigger failure rate, and you're estimating 80 to 90% simulated placebo. But just wondering if you may actually need to see a lower failure rate since placebo, you know, if you look at Humira and Fogatinib, you know, placebo can be highly variable.

On development strategy selection of indication and then just strong execution and the ability to move fast.

It is also something we are.

Really proud of in terms of the environment I guess first of all yeah, we're watching the sort of change in the biotech market unfolds I would say like there are certain kinds of opportunities like.

People used to ask US all the time about the number of biotech companies trading under cash some of those dislocations are probably changing a little bit as people feel like they've got better access to capital. Some arent there are still plenty of companies out there that you know.

Because they don't fit the exact current moment in time are still.

Not sort of obviously in Vogue.

So we're looking broadly and I think that's all sort of positive. That's the main driving factor of of our opportunity set right now isn't about capital markets, It's what's going on in big pharma.

Matthew Gline: Yeah, thanks. Actually, I'll hand it over to Mayukh to give his thoughts on that question. If not, I can take it. You might be on mute.

That is not changing that as the level of EPS pressure.

Mayukh Sukhatme: Yeah, no, I'm on. There we go. No, I don't have too much too much there. I mean, look, I think you both, I think the, you know, look, I think we're looking at this in the same way that we look at all of our trials. We want to see for ourselves a pretty clear outcome, a clear signal of efficacy, I think even accounting for, you know, some potential variability and a sort of notional placebo rate, and we'll be excited to move forward if it's clear. The only other thing I'd add is, remember, this is a 24 patient study, it's randomized in favor of the 45 milligram arms. My experience, and our experience, looking at phase two data is that you sort of expect it to be like, You hit F9 on the computer, and you get a green thumbs up or a red thumbs down. And usually, what you get is, you know, like a greenish triangle or something like that. And you're like, what does that mean?

It is significant.

There are patent expirations.

Coming.

Cross a number of different pharma companies frankly, most of the industry.

And the IRI is forcing our partners to rethink their development plans in various ways and I think that combination of factors.

Means that R&D portfolio prioritization has to happen at these companies and.

If you are a big pharma company and if you're really prioritizing your portfolio. What we think you want in a partner is the capital to run a good programs the execution to do a good job with it.

And a willingness to be creative and thoughtful on structure to provide mutual benefit and I think there is basically nobody else at least in sort of biotech.

Has the track record at those things that we do so we think that sets us up as a partner of choice for <unk>.

Set of partners that have real need.

Okay.

Thank you.

Ladies standby for our next question.

Our next question comes from the line of Neenah, Bitrates Hilgart with Deutsche Bank. Your line is open.

Hey, guys. Thanks for taking my question. So just a question about that non infectious uveitis study can you just remind us what the definition of failure is that you're using in the study I know in some of the other studies that that kind of multi factorial definition and then on CIB peed data for the tokamak just wondering what you would consider to be kind.

Matthew Gline: And so, I think you can imagine, it's hard to reduce the extra data that we're going to get from the study into a single number. We did set that bar of a 70% treatment failure rate, but I think you can, you can be clear. We're going to be looking at every patient and trying to make sure we understand what the drug is doing. And these are quite sick patients again, 30,000 new cases of blindness every year.

The meaningful difference from a dose ranging perspective between 340 and 686.

Yes. Thanks.

Thanks Nina.

And welcome back.

On Niu.

My Yugra, Frank feel free to chime in I think our definition is kind of.

In line with.

Matthew Gline: So, you know, it's something where we feel like we have an opportunity to make a big difference with the right clinical picture. There are two other points to add here. I think, look, we are sort of hoping to see, you know, a bit of a dose response here, and that, while there's not a placebo, there is a relatively low dose of BREPO that ought to give a little bit of a, let's just call it maybe not a placebo, but something kind of closer to placebo on efficacy and the 15 milligram dose.

Where the other definitions and I don't I don't have the exact definition right in front of me. So I can sort of make sure. It gets out there. After the fact with mediocre Frank do you have the exact definition handy.

No worries if not.

And then.

<unk>.

Again, I think this is a little bit of a of a.

The balance of factors kind of a question, but look I think.

What what we've seen so far in IDP is.

<unk>.

I V <unk> like.

Response rates, if I had to characterize them.

Mayukh Sukhatme: That's thing one. And thing two is, I think, in contextualizing the Humira, you know, sort of comp that you cited, we've got a more aggressive steroid taper in our study than in the Humira study. And so you'd expect to see, you know, a higher placebo failure rate as a result. Okay, thank you. Thanks, Dennis.

And I think what we would hope to see in the higher dose is evidenced that we can clear that bar something that looks sort of.

Better to our patients and providers and physicians eyes than IV AG from an efficacy perspective, I think that's kind of where our general head is at on what we could be able to deliver there.

Got it thank you.

Alright, the definition the primary differentiator is discontinuation or Intercurrent event at week 24.

Perfect. Thanks.

Matthew Gline: Please stand by for our next question. Our next question comes from the line of Louise Chen, who has cancer. Your line is open.

Thank you.

Please standby for our next question.

Our next question comes from the line of Yatra and <unk> with Guggenheim. Your line is open.

Louise Alesandra Chen: Hi, thanks for taking my question here. I wanted to ask you first how you plan to address the concentration in the shareholder base. Will that kind of all be done together with some of the announcements that you plan to make before the next earnings call? And then the second thing I wanted to ask you was about the expansion of your pipeline; what therapeutic areas are you most interested in? And if you can't say what therapeutic areas you're most interested in, how competitive do you want to get with some of the most topical areas that people are investing in right now? Thank you. Thanks, Louise. Thanks for listening. And those are both really good questions.

Thank you, Matt Nice update there.

Maybe on the Tam could you talk about what youre seeing from a competitive dynamic.

Your efforts on the marketing Sun.

Continuing to invest similar dollar.

And you know what.

Like how should we think about inflection with atopic dermatitis, where there was a time hung around data and how much of that infrastructure ability to.

Built around <unk>.

And also could you also comment on the net to EBITDA, how should we think about calendar 'twenty 'twenty four from that deal perspective things yes.

Perfect. Thank you got it I appreciate the question.

They're sort of exactly the right exactly the right ones from a competitive dynamics perspective, I think we still.

Matthew Gline: You know, on the shareholder base side, I think the first answer is that is not a decision that we can make unilaterally. It depends on our desires, but also the desires of some of our concentrated shareholders, who, in many cases, are happy holders and frankly, believe what we believe, which is that our stock is meaningfully undervalued, given the, whether that means we clean them up at once, whether it means we clean some of them up, you know, I think that depends a little bit on their needs and their appetites and on making the right economic decisions. So, you know, stay tuned is the short answer. On the BD question, and again, I'll ask Mayukh if he has comments as well, but, you know, I think the short answer is we are sort of necessarily agnostic to therapeutic areas because so much of our opportunity comes from strategic shifts and focus at our partners and that leads them to need to, you know, rethink their portfolio. So, you know, if someone is doubling down on immunology, maybe something else is falling out as a consequence. So I think we're pretty flexible.

Look narrowly versus the other novel topical agents in psoriasis I think we still we still see patients physicians choosing us.

Preferentially the truth is as we've said we've never been that focused on novel topical agents, we've always been focused on capturing share from topical corticosteroids.

Historically as that continues to be work.

The sort of high prescribing docs right the product all the time and are really excited about it and then there's a long tail who right at four times, a month and think Thats, a lot and I think haven't sort of come around to our view yet, but they can write at 50 times a month so.

We're working through.

Those dynamics and I'm optimistic that that behavior is changing over time.

Just a couple of other competitive events, obviously, one of our competitors recently launched a phone that doesn't directly impact.

The addition of our products were not being used a lot on the scalp anyway. So I think that should be a good indication for them, but not something we're focused on we've obviously done some work ourselves on a phone and.

What could you do you think about expansion opportunities in that direction as far as <unk> is concerned.

It's just it's a huge market.

We are excited for our product profile, which we think bluntly is even more differentiated.

He then in psoriasis <unk> is also in many ways the less developed and potentially faster growing market and it's also a market that is more primed for novel topical in psoriasis was because there've been a few more on the market ahead of us and so we can also look to take share not just from steroids, there, but from maybe some competitors that are established that.

Matthew Gline: In general, because we're in that sort of string of pearls, one program from here, one program from there dynamic, what that tends to mean is we are more excited about areas where a single program can kind of stand on its own. So think of the immunology programs that we've developed, for example, and maybe a little bit less excited about areas where you need a concentration, either because it's like oncology where you're developing multiple drugs in combination or to have a coherent plan, or, you know, maybe because it's something like cell and gene therapy where you have a sort of a need for manufacturing expertise that provides an economy of scale. So it's not that we would not go into either of those areas, but they're probably, modestly, less likely for that reason. Mayukh, anything you'd add to that?

Yes, I think what we will wind up focused most on for the quarter of that launch that will happen during our next fiscal year.

We will get the approval kind of late this calendar year.

And then we'll be looking at sort of that next fiscal quarter I think we'll be looking at script volume uptake there and looking to see.

Some real growth.

We have said previously we expect to increase the number of reps for about 100 to about 125, I don't think theres like a massive change to our commercial infrastructure, but we're still thinking through.

In real time, as we learned from the psoriasis side, what to do for DTC concurrent with that launch et cetera, that's all sort of.

Ongoing the prescriber base is also a little bit different it's a little bit more dispersed. So we're giving some thought to ways to reach docs beyond.

Mayukh Sukhatme: Yeah, I think as we look, and this is really typical of the history of the company, I think as I kind of look at the list of things that I would say that we're excited about and prosecuting, and pursuing right now, it's about as eclectic a list as one could kind of, you know, imagine in terms of therapeutic areas. So, as Matt said, we're going to continue to be therapeutic area agnostic. I think that, you know, we have tended, for the reasons that Matt stated, to be in areas that probably, at first glance, tend to be a little bit off the beaten track or a little bit of a contrarian. And sometimes, you know, I think we've shown that sometimes those areas tend to heat up, as we have sort of seen with FCRN and then with TL1A in the past. And so that could well happen again. But probably, you know, again, just to make sure I'm feeling it, I tell you. Go ahead, Mayukh. No, no, go ahead.

Just a dermatologist, but stay tuned for potential ideas there.

And then sorry, you might have had.

Yeah look I think.

It's been sort of slow and steady ish for us there is still a little bit of lumpy contracting stuff to get through just as some of the contracts have kind of turned over or changed but in general I would say like.

Slow and steady accretion over the course of the year.

We may dip a little in the first quarter for or be flattish in the first quarter for sort of normal reasons related to plan resets et cetera.

And then my guess is the <unk> launch won't like halt our progression, but it may momentarily slowly as we just need to make sure a formulary sort of gets set up they are quickly. So I think probably slow and steady is the right way to think about GTS.

Through 2024.

Yeah.

Thanks, Ken.

Please standby for our next question.

Our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is open.

Okay.

Hi, good morning, Thanks for taking my questions just.

Matt you indicated.

That you're sort of still.

Matthew Gline: The bar for us is not, is it competitive? The bar for us is, can we get something that makes sense for us given the development plan, the economic terms, et cetera. And so, you know, there are occasionally programs in very competitive spaces where idiosyncratic factors make them competitive from a sort of, like, many people care about them perspective that are nonetheless easy for us to get. And then there are sometimes programs in less competitive areas, but nonetheless, they're harder to pry loose.

Because agnostic I guess in terms of therapeutic area.

After you did announce the telecom transaction with Roche you sort of said that having.

And much greater cash balances potentially positioned you too.

Sort of take.

Big opportunities further into development does that influence aware or sort of certain therapeutic areas that you might favor. Because obviously you have the outlines is such a strong ini portfolio right now.

Yeah. Thanks, Doug I appreciate the question.

As always.

Matthew Gline: And so I think it's not about how many other people are doing it; it's about what we can get our hands on. Thank you, Louise.

First of all.

I continue to appreciate the please begin coherence we have an ini.

We think <unk>.

CRM fits nicely with reps hitting their books that mill, a madman sarcoid is sort of hearing in the same direction. So look I think.

Corinne Jenkins: Thank you. Please stand by for our next question. Our next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is open. Good morning.

Stent that we see things that worked for us.

Theres something nice to the AD.

Matthew Gline: Maybe as a follow-on to Louise's question, how do you think about Roivant's ability to add value to the assets that you're considering in those deals? And what do you view as the company's core competencies in that context? And then I was also wondering, you say that the environment is sort of in really good shape, it's the best it's ever been, but what metrics are you seeing that inform that comment? [inaudible] Yeah, thanks, Corinne. Those are both really good questions.

I think in many ways.

What our capital base and frankly, our history of development.

Remember some of our first phase three programs were in.

We're in endometriosis, and uterine fibroids, and an overactive bladder, which are not necessarily indications that were jumping up and down about literally right now for new programs, but they are big studies in big indications and we have a lot of history.

In that kind of disease states one of the things that I think frankly differentiates us from many biotech companies as their capital base allows us to do larger studies for broader populations and so I think.

Matthew Gline: You know, first of all, I think it is unquestionably the case that the thing we have done most in our history and best in our history is creative, thoughtful, aggressive clinical development. We have run 10 positive Phase III studies. We have run many, many Phase II studies. We have changed indication plans for programs where we thought that made sense. We have done, we think, quite a good job at late-stage development for programs, but we were happy with the choice of indication. So, I think, first and foremost, I think about the value we add when we look at a new program. I think the ability to be efficient, thoughtful, and creative in development strategy, selection of indications, and then just strong at execution, the ability to move fast, is also something we are really proud of.

We will potentially take advantage of that.

Both because those can be big opportunities.

And because.

There are opportunities that will sort of necessarily get passed over by smaller folks who don't have the capital position of the development experience to take them on so I think that is a competitive opportunity for us.

That we will be and that we will be taking advantage of.

In that I guess as a follow up to the extent that you, perhaps do you pursue opportunities outside of <unk>.

Hi would you think about sort of new areas is one thing, which you would want to start to build some scale, meaning if you execute it.

One single transaction its potential therapeutic areas would you be what likely looking to add to that.

Yes.

The discussion that we have internally.

As we look at our pipeline and again there are things that we see where we see a program and it makes more sense as a part of our portfolio than it does sort of on a standalone basis I think it's certainly possible.

Matthew Gline: In terms of the environment, I guess, first of all, yeah, we're watching the sort of change in the biotech market unfold. I'd say, like, there are certain kinds of opportunities. For example, people used to ask us all the time about the number of biotech companies trading under cash. Some of those dislocations are probably changing a little bit as people feel like they've got better access to capital. But some aren't.

Build out additional programs that they will become <unk> of scale.

It's important to note, though we evaluate every program on its own merits. We evaluate every program based on the data we've got and I think we're going to pursue.

Sort of value and risk.

Over.

Matthew Gline: There are still plenty of companies out there that, you know, because they don't fit the exact current moment in time, are still not sort of obviously in vogue. And so we're looking broadly, and I think that's all sort of positive. That's the main driving factor of our opportunity set right now isn't the biotech capital markets. It's what's going on in big pharma. And I'd say that is not changing. That is, the level of EPS pressure is significant.

Overshot, a therapeutic concentration per se, but.

I'll hand, it over to you.

Yes, I think look I think as you.

Seen from US typically when we when we bring in a new program I mean, it's sort of like by definition, it's got to have enough half two.

You kind of stand on its own I think that's the lens through which we look look at it that's the lens through which we sort of hire a team to sort of prosecute around it.

We typically call it an event, but thats kind of how we think about it.

Matthew Gline: There are patent expirations coming across a number of different pharma companies, and frankly, most of the industry. And the IRA is forcing our partners to rethink their development plans in various ways. And I think that combination of factors means that R&D portfolio prioritization has to happen at these companies. And if you are a big pharma company and you're reprioritizing your portfolio, what we think you want in a partner is the capital to run a good program, the execution to do a good job with it, and a willingness to be creative and thoughtful on structure to provide mutual benefit. And I think there is basically nobody else, at least in sort of biotech, that has the track record for those things that we do.

Lastly, I guess I would say I can't underscore the comment Matt made.

About capital being a major competitive advantage for us.

Hum.

Both in terms of.

Both in terms of I think like what that brings is a solution to a you know a.

A prospective pharma partner and that we have this sort of scale of capital that is meaningful to them and that is unique to us.

And so.

I think we do.

We view that as precious.

Great. Thank you so much.

Thanks, Doug for the question appreciate it.

Please standby for our next question.

Our next question comes from the line of Robin Conoco split choice Securities. Your line is open.

Matthew Gline: So we think that sets us up as a partner of choice for a set of partners that have real needs. Thank you. Please stand by for our next question. Our next question comes from the line of Neena Bitritto-Gard with Detroit Bank. Your line is open. Hey guys, thanks for taking my questions. So just a question about the non-infectious uveitis study. Can you just remind us what the definition of failure is that you're using in the study? I know in some of the other studies, it's a kind of multifactorial definition.

Hey, this is Michelle on for Rob.

And thank you for taking my question so.

Maybe on <unk>, you mentioned, you know you'll see any fluence Tony.

Next year, you mentioned that last call you'll see overall you would each have to reach 50% steady state or do you still believe that to be the number for duty and long term to reach 50% of any state and in terms of big picture for the company how many assets would you retain.

Our long term thank you.

Yes. Thanks, I appreciate the questions and thanks for thanks for listening.

Neena Marie Bitritto: And then on the CIDP data for tokomab, just wondering what you would consider to be kind of a meaningful difference from a dose ranging perspective between 340 and 680. [inaudible] Thanks, Neenas, and welcome back. On NIU, Mayukh or Frank, feel free to chime in. I think our definition is kind of in line with the other definitions. And I don't have the exact definition right in front of me, so I can sort of make sure it gets out there after the fact. But Mayukh or Frank, do you have the exact definition handy?

Yeah.

The GCN question look I think.

I have no real change to like the long term steady state guidance I think it's going to take it.

Time of scale.

Especially because remember a meaningful portion of the remaining yield accretion comes from volume.

It's really just can take some time to build up too so.

I think our guidance of 50% is sort of the same as let's say every other biotech launched program.

I think that the trends that buffet us will be largely the same as the trains that buffett other programs.

No change to to sort of long term steady state guidance per se.

And then.

Assets that we retained for the long term.

Matthew Gline: No worries, if not. And then on CIDP, you know, again, I think this is a little bit of a balance of factors kind of question. But look, I think what we've seen so far in CIDP is, you know, like, IVIG-like response rates, if I had to characterize them. And I think what we would hope to see in the higher dose is evidence that we can clear that bar, something that looks sort of better to a patient's, provider, and physician's eyes than IVIG from an efficacy perspective. I think that's kind of where our general head is at on what we could be able to deliver there. Got it. Thank you. Sorry, the definition, the primary definition is discontinuation or an intercurrent event at week 24.

I think the short answer is we bring in programs that we are excited to invest in that we believe will be important commercially that we believe we will generate important clinical data on and basically everything we bring in our plan is to retain it and develop it and I think the thing that throws us off that trajectory is just the information we learn along the way both in terms of the <unk>.

Quality of the data that we generate and in terms of what other people think of the program and what their plans might be but I think if you.

Gave me a crystal ball and it showed that we kept all of the programs in our pipeline and they were sort of commercial opportunity for us down the line I'd be pretty excited about that I. Just I think we will continue to be ruthlessly economic along the way.

Some of the targets. We're working on are really attractive targets not just to us but to prospective partners. So I think that could that's the kind of thing that takes us off that path.

Thank you.

Thank you.

Okay.

Ladies and gentlemen at this time I would like to turn the call back over to Matt for closing remarks.

Matthew Gline: Perfect. Thanks. Great. Thank you. Please stand by for our next question. Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is open.

Thank you everybody. Thanks for listening. Thank you operator for moderating thanks to all our analysts and obviously to be.

To all of our investors into the entire team at Raven, we appreciate it another.

Yatin Suneja: Thank you. Matt, nice update here. A question, maybe on Vitama.

Another quarter with a lot for us to be proud of and a lot to look forward to building year for 2024, So yes looking forward to getting back on the phone I'm sure. We'll do it multiple times to come and I will speak to you all soon.

Matthew Gline: Could you talk about what you're seeing from a competitive dynamic, your efforts on the marketing front, you continue to invest similar dollars, and, you know, what. Like, how should we think about inflection with atopic dermatitis? What is the timeline around it? And how much of the infrastructure bill you would have to build around AD? And also, could you also comment on the net yield?

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Okay.

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Matthew Gline: How should we think about calendar 2024 from a net yield perspective? Yeah, perfect. Thank you, Yatin. I appreciate the question. They're sort of exactly the right ones.

Matthew Gline: You know, from a competitive dynamics perspective, I think we still look narrowly versus the other novel topical agents in psoriasis. You know, I think we still see patients, and physicians choosing us preferentially. The truth is, as we've said, we've never been that focused on novel topical agents. We've always been focused on capturing share from topical corticosteroids. You know, we've said historically, if that continues to work, the sort of high prescribing doctors write the product all the time and are really excited about it, and then there's the long tail who write it four times a month and think that's a lot.

Yeah.

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Matthew Gline: And I think they haven't sort of come around to our view yet that they can write it 50 times a month. So, you know, we're working through those dynamics, and I'm optimistic that that behavior is changing over time. There are a couple other competitive events. Obviously, one of our competitors recently launched a foam that doesn't directly impact the utilization of our product. We're not being used a lot on the scalp anyway.

Yes.

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Matthew Gline: So, I think that should be a good indication for them, but it's not something we're focused on. We've obviously done some work ourselves on the foam, and we'll continue to think about expansion opportunities in that direction. You know, as far as AD is concerned, It's just, it's a huge market, and we are excited for our product profile, which we think, bluntly, is even more differentiated in AD than in psoriasis. AD is also, in many ways, the less developed and potentially faster-growing market, and it's also a market that is more primed for novel topicals than psoriasis was because there have been a few more on the market ahead of us, and so we can also look to take share, not just from steroids there, but from maybe some competitors that have established themselves.

Okay.

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Matthew Gline: You know, I think what we will wind up focused most on for the sort of quarter of that launch that will happen during our next fiscal year. Again, we'll get the approval kind of late this calendar year, and then we'll be looking at, sort of, that next fiscal quarter. I think we'll be looking at script volume uptake there and looking to see some real growth. As we have said previously, we expect to increase the number of reps from about 100 to about 125. You know, I don't think there's going to be a massive change to our commercial infrastructure. But we're still thinking through in real time, as we learned from the psoriasis side, what to do for DTC concurrent with that launch, etc. That's all sort of ongoing. The prescriber base is also a little bit different. It's a little bit more dispersed.

Yeah.

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Matthew Gline: So we're giving some thought to ways to reach doctors beyond just dermatologists. But you know, stay tuned for potential ideas there. And then, sorry, you might have had a GTN.

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Matthew Gline: Yeah, look, I think it's been sort of slow and steady-ish for us. There's still a little bit of lumpy contracting stuff to get through just as some of the contracts have kind of turned over or changed. But in general, I'd say, slow and steady accretion over the course of the year.

Matthew Gline: You know, we may dip a little in the first quarter or be sluggish in the first quarter for sort of normal reasons related to plan resets, et cetera. And then, you know, my guess is the AD launch won't, like, halt our progression, but it may momentarily slow it as we just need to make sure formulary sort of gets set up there quickly. So I think, you know, probably slow and steady is the right way to think about GTN through 2024. Thanks, y'all. Please stand by for our next question, which comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open. Hi, good morning.

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Douglas Dylan Tsao: Thanks for taking the questions. Just, Matt, you indicated that you were sort of still sort of agnostic, I guess, in terms of therapeutic areas. After you did announce the Taliban transaction with Roche, you sort of said that having, you know, a much greater cash balance potentially positioned you to sort of take on big opportunities further into development. Does that influence where or sort of certain therapeutic areas that you might favor?

Okay.

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Matthew Gline: Because obviously, you have the outlines of such a strong INI portfolio right now. Yeah, thanks, Doug. I appreciate the question and your thoughtfulness as always. You know, you know, I think, first of all, we continue to appreciate the pleasing coherence we have in I&I. We think FCRN fits nicely with Repositnib, that Milamab and Sarcoid are sort of hewing in the same directions.

Okay.

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Sure.

Matthew Gline: So look, I think, to the extent that we see things in I&I that work for us, there's something nice about that. You know, I think in many ways. Our capital base and, frankly, our history of development in, remember, some of our first phase three programs were in endometriosis and uterine fibroids and overactive bladder, which are not necessarily indications that we're jumping up and down about literally right now for new programs, but they're big studies and big indications, and I think we have a lot of history in that kind of disease state. You know, one of the things that I think, frankly, differentiates us from many biotech companies is that our capital base allows us to do larger studies for broader populations. And so I think we will potentially take advantage of that both because those can be big opportunities. And because, you know, there are opportunities that will sort of necessarily get passed over by smaller folks who don't have the capital position and the development experience to take them on.

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Matthew Gline: So I think that is a competitive opportunity for us that we will be taking advantage of. In that, I guess, as a follow-up, to the extent that you perhaps do pursue opportunities outside of I&I, would you think about sort of new areas as ones in which you would want to start to build some scale, meaning if you executed a new single transaction in a potential therapeutic area, would you likely be looking to add to that? Thank you.

Okay.

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Matthew Gline: Yeah, you know, it's a discussion that we have internally as we look at our pipeline. And again, there are things that we see where, you know, we see a program, and it makes more sense as a part of our portfolio than it does sort of on a standalone basis. So I think it's certainly possible as we build out additional programs that they will become nexuses of scale. I think it's important to know, though, that we evaluate every program on its own merits. We evaluate every program based on the data we've got.

Okay.

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Matthew Gline: And I think we're going to pursue sort of value and risk over sort of therapeutic concentration, per se. But Mayukh, I'm going to hand it over to you. Yeah, I think look, I think if you've seen from us, typically, when we bring in a new program, I mean, it's sort of like, by definition, it's got to have enough heft to kind of stand on its own. I think that's the lens through which we look at it, that's the lens through which we sort of hire a team to sort of prosecute around it. You know, we typically call it a new vent, but that's kind of how we think about it. And, you know, as I guess, like, I would say, I can't emphasize the comment Matt made enough about capital being a major competitive advantage for us, you know, both in terms of both in terms of I think, like what that brings as a solution to, you know, a prospective pharma partner and that we have the sort of scale of capital that is meaningful to them, and that is unique to us. And so, you know, I think we view that as precious.

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Sure.

Matthew Gline: Great, thank you so much. Thanks, Doug, for the question. Appreciate it. Please stand by for our next question. Our next question comes from the line of Robyn Karnauskas with Truist Securities. Your line is open. Hey, this is Nishant.

Okay.

Yes.

Thank you.

Yes.

Thank you.

Yes.

Okay.

Okay.

Nishant Shailesh Gandhi: I'm on behalf of Robyn. Thank you for taking our question. So maybe on Vitama GTN, you mentioned, you know, you see a steady, slow and steady over the period of next year. You mentioned that last call, you see overall, you reach a to reach 50% steady state. Do you still believe that that to be the number for GTN long term to reach 50% steady state? And in terms of the big picture for the company, how many assets would you retain over the long term?

Yes.

Thanks.

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Thank you.

Matthew Gline: Yeah, thanks. Appreciate the questions. And thanks. Thanks for listening. You know, on the GTN question, look, I think I have no real change for the long-term steady state guidance. I think it's going to take time and scale, especially because, remember, a meaningful portion of the remaining yield accretion comes from volume, which is going to take some time to build up to.

Yes.

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No.

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Matthew Gline: So, but I think our guidance to 50% is sort of the same as, let's say, every other biotech launch program. And I think the trends that buffet us will be largely the same as the trends that buffet other programs. So no change to sort of long-term steady state guidance per se. And then, you know, assets that we retain for the long term. I think the short answer is that we bring in programs that we are excited to invest in, that we believe will be important commercially, that we believe we will generate important clinical data on. And basically, everything we bring in, our plan is to retain it and develop it. And I think the thing that throws us off that trajectory is just the information we learn along the way, both in terms of the quality of the data that we generate and in terms of, you know, how we're going to use it.

Yes.

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Matthew Gline: What other people think of the program and what their plans might be. But I think, you know, if you gave me a crystal ball and it showed that we kept all of the programs in our pipeline and they were sort of commercial opportunities for us down the line. I'd be pretty excited about that. I just, you know, I think we will continue to be ruthlessly efficient along the way and some of the targets we're working on are really attractive targets, not just to us but to prospective partners. So I think that could could be the kind of thing that takes us off the subject.

Yes.

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Thanks.

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Matthew Gline: Thank you. Ladies and gentlemen, at this time, I would like to turn the call back over to Matt for his closing remarks. Thank you, everybody. Thanks for listening. Thank you, Operator, for moderating. Thanks to all our analysts and, obviously, to all of our investors and to the entire team at Roivant. We appreciate it. Another quarter with a lot for us to be proud of and a lot to look forward to in building Europe for 2024.

Okay.

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Matthew Gline: So yeah, looking forward to getting back on the phone. I'm sure we'll do it multiple times to come and I will speak to you all soon. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. ??? ??? ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Hello, thank you for standing by. Welcome to Roivant third quarter 2023 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. And you will then hear an automated message.

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Hello, Thank you for standing by welcome to avoid that third quarter 2023 earnings conference call at.

At this time all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session to ask a question. During this session you will need to press star one on your telephone.

And you will then hear automated message.