Barivion at Goldman Sachs Conference: Strategic Moves in TED Market

On Monday, 09 June 2025, Barivion (NASDAQ:VRDN) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, outlining its strategic advancements in the Thyroid Eye Disease (TED) market. The company highlighted its progress on the VELI IV therapy, upcoming BLA filing, and the potential for priority review, while addressing challenges like declining TEPEZZA sales. Barivion is positioning itself as a competitive player with a differentiated product profile and a robust pipeline.

Key Takeaways

• Barivion plans to file a BLA for VELI in the second half of the year, leveraging its breakthrough therapy designation for potential priority review.
• The company is preparing for a commercial launch with a senior team in place, emphasizing a shorter infusion schedule and lower drug volume compared to TEPEZZA.
• Barivion estimates the TED market to be larger than previously thought, with a potential total addressable market (TAM) of 190,000 to 200,000 patients.
• The VRDN003 subcutaneous formulation is advancing through phase three studies, with top-line data expected in the first half of next year.
• Barivion is exploring European commercialization, targeting an MAA filing in the first half of 2026.

Operational Updates

Belly (IV Program):

• BLA filing is on track for the second half of this year, with breakthrough therapy designation increasing the odds for priority review.
• A senior commercial team is in place, ready to execute launch plans.
• The company is monitoring TEPEZZA sales and market conditions closely.

VRDN003 (SubQ Program):

• Phase three studies (REVEAL one and REVEAL two) are progressing well, with a BLA submission anticipated by the end of next year.
• The subcutaneous formulation is considered de-risked, sharing common design features with VELI.

FcRn Portfolio:

• Healthy volunteer data is expected in Q3 this year, with an IND filing for a half-life extended version by year-end.
• First in human data is anticipated next year.

Future Outlook

Belly:

• Barivion aims for a US commercial launch following BLA approval, with the potential for priority review to accelerate timing.

VRDN003:

• Launch plans are set for a year after the IV launch, offering subcutaneous options with an auto-injector.

Expansion:

• The company is exploring commercialization opportunities in Europe and Japan, with plans for an MAA filing in Europe by the first half of 2026.

Q&A Highlights

• Barivion believes the TED market is larger than Amgen’s estimate, projecting a TAM of 190,000 to 200,000 patients.
• The company emphasizes its strong chronic data, particularly in diplopia resolution.
• Long-term durability data shows 70% of patients maintained their proptosis response at week 52.
• Barivion highlights its lower placebo-adjusted hearing effect compared to TEPEZZA.

In conclusion, Barivion’s strategic initiatives and market insights at the conference underscore its commitment to advancing in the TED market. For more detailed insights, refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Rich, Host, Goldman Sachs: Alright. Good morning. Welcome. So for the next session, we have Steve Mahoney and Sean Wu from Barivion. Welcome to your second Goldman Sachs conference.

And before we get started, I’m gonna turn it to you guys for the opening remarks.

Steve Mahoney, Barivion: Okay. Well, great. Rich, thank you for having us here today. We may be making forward looking statements during the course of the presentation, so please refer to our SEC filings for the risk factors. We are advancing the portfolio on across the board.

Everything’s on track. Everything’s moving well. We’ve as you know, we finished our phase three studies well, we had our top line data readouts for our phase three studies in active and chronic patient populations last year. Data was overwhelmingly positive across all the endpoints, all the time points, so very encouraging phase three data. We’re now marching towards BLA filing in the second half of this year.

We’re just waiting for the THRIVE-two chronic study follow-up period data to come in, and we’ll be able to do that. So everything’s on track there. We just recently announced our long term follow-up data for the ACTIVE study, which looked very promising, answered the question as to whether we would see a durability of response. We thought that was pretty clear from that data, which was great. And we also announced recently our breakthrough therapy designation, which obviously was quite validating from the FDA to get that designation, essentially says that they feel that we have the potential to substantially improve the against the standard current standard of care.

So that would be that’s obviously great. It it also increases our, potentially, our odds for priority review to pull in the launch timing. So IV program moving along, great. And then we’re also enrolling our subcu program in our phase three studies there, REVEAL one and REVEAL two. That is also all on track.

It will have first line top line readout first half of next year. So the TED portfolio is moving right along and doing well. We also have an FcRn portfolio. We’ve got healthy volunteer data coming out in q three this year. That will that will help us determine IgG suppression, albumin sparing, and we’ll get an insight into some dosing.

And we think that our development of the Fc fragment, the only other company out there developing the Fc fragment be it beside Vivgart, and we’re pretty excited about that. And we also have our half life extended version of FcRn, which could be a potential game changer, but we’re filing an IND on that at the end of this year as well. So we’ll get first in human data next year. So portfolio is moving well, well capitalized, and we’re in good shape.

Rich, Host, Goldman Sachs: Fantastic. Obviously, this is a very important year. A lot of execution going on. Mhmm. Maybe just a little bit about what we should expect to see.

I know you mentioned you guys are looking to file the BLA for Belly. Are we gonna see are you guys gonna show any of the fifty two week safety data, or is that something that you would show show to investors? And, also, how how is the the review one and two study going for for o three? Is that on track to have data coming next year still?

Steve Mahoney, Barivion: Yeah. So answer the last question first. Yes, OO3 is on track. Just a reminder, the SubQ antibody and the IV antibody are essentially the same antibodies. The only difference being the half life extension technology in the SubQ.

So we do expect that the subcu will behave similarly to the IV antibody because it’s the same binding domain, same CDRs. So it’ll block the receptor the same way. We saw in the healthy volunteers, we saw very comparable PKPD data, which is what we wanted to see, and that gave us confidence to go right into phase three on the back of that healthy volunteer data. BLA BLA filing is on track. Like I said, sec second half of this year, and we’re waiting for the Thrive two chronic data to finish the follow-up period.

And then we’ll we’ll drop that into the BLA, and then we’ll be ready to go. And would you show the fifty two week follow-up safety? So we we showed the fifty two week follow-up safety data for the ACTIVE study. We had that. We included that when we did the durability response on proptosis.

Safety profile looked great. Vast majority of of NEAEs reported that were all mild anyway. They all resolved. The vast majority of them resolved. So the safety profile and the follow-up period looked good, again, as expected.

Rich, Host, Goldman Sachs: Right. Okay. Fantastic. So, obviously, there’s a lot of you know, you guys expecting to file the BLA, and then and right after that, you would have to prepare for the commercial Mhmm. Launch.

And and how how is that part of the the preparation going?

Steve Mahoney, Barivion: Yeah. We’ve had a senior commercial team in place for quite a while as as you should when you we expect to launch. So we’ve got chief commercial officer, marketing, sales operations, supply chain, market access, importantly. So we’ve got we’ve got the team in place, and we’re built out our launch plans. If we do get priority review because breakthrough therapy designation can often lead to priority review.

It’s the same review criteria. We’ll have to, you know, we’ll have to request that once we file the BLA, but we think they it increases our odds certainly that breakthrough therapy can increase your odds for priority review. And if we got that and we were so we’re planning as if we’re getting that. So we’re gonna be ready no matter what happens to launch, and we’ve got a very experienced team to be able to do that.

Rich, Host, Goldman Sachs: Fantastic. And, obviously, you guys have been monitoring capacity sales. That’s a very important metric to to investors, to the market, and, obviously, to you guys as well. And when you look at that sales, it’s been declining little bit in in 1Q twenty five. What do you think is driving that decline?

And how do you think of the overall condition of the market in terms of is it gonna continue to trend that way, or is it gonna you see a more stability of the the

Steve Mahoney, Barivion: Well, I think I think first and foremost, like, let’s let’s acknowledge that we’re still talking about a $2,000,000,000 market, right, roughly. So we think that with our IV profile, which we just showed in our phase three, both in active and chronic, and the differentiation, again, trial comparisons, but, you know, the breakthrough therapy designation kind of supports this, is our data looks really good. And we think that particularly with the diplopia, complete resolution diplopia response, rapid onset of treatment effect, and the durability of response and the safety profile. Don’t forget we had lower hearing impairment rates. That’s a key area of interest for folks on the safety side.

We had lower rates despite the fact that we were looking for it versus when TEPEZZA ran their trials, they weren’t really looking for it because it wasn’t known. So that all that all, in our view, offers a differentiated profile. Again, cross trial comparisons, but again, breakthrough therapy supports this. We think that profile being introduced into the market with more treatment options available to patients with five infusions versus TEPEZZA’s eight infusions, ten mgs per kg versus twenty mgs per kg, seventy percent less drug going in and getting this clinical outcome, we think that’s gonna open the door for more patients and encourage them to come in and get access to this drug. So we think regardless of what TEPEZZA’s performance is, we think the market’s certainly healthy.

Look at our clinical trial enrollment. We enrolled over 400 patients in trials last year. There are other trials out enrolling for thyroid eye disease patients as well. But that’s pretty healthy demand coming from the market side. And over half of those came out of The US, by the way.

So we think that patients are certainly there, and we think a different profile with more treatment options for patients will drive. And then obviously, when SubQ comes in, we expect SubQ to be available a year after IV. We that’ll even drive further penetration because now we can mail an auto injector to your house and you’re not you don’t have to go to an infusion center. But we do think, just to be clear, IV will stick around. There are pace there are physician patients in a controlled setting, and there are patients who wanna be in a controlled setting of an IV infusion center.

Rich, Host, Goldman Sachs: Fantastic. So when you watch TV, you see a lot of DTC on TET from from Amgen. So there’s a lot of awareness going on. And then I think Amgen has mentioned that they have been getting good traction with the ocular specialists. Mhmm.

But and they’re looking to expand to ophthalmologists and endocrine endocrinologists, but that seems to be a little more challenging to do. How are you guys thinking about sort of the commercial in terms of what you need to do to build awareness? Do you still are you looking at the three sort of class of physicians that you would wanna target? Are these the the same type of physician? Yeah.

And also, how do you think about the awareness that’s being created? Do you have to come out and sort of match the same sort of, like, awareness DTC campaigns?

Steve Mahoney, Barivion: Yeah. First, I think everything that they’re doing is is benefits us. They’re educating patients, disease awareness, they’re educating physicians on IGF-1R inhibition, and they’re educating payers. So we benefit from all that because again, we come in and we have the same mechanism, same target. So our conversations are certainly a lot easier, particularly when you when we have the profile that we have.

I think we should start there. That’s that’s all to our benefit. We actually we think that broadening the approach that like they’ve done with respect to more general ophthalmology and endocrinology. Those will be that’s more of a in our view, more of a referral network to the neuro ophthalmology and the ocular plastics who are the primary prescribers of for TET. Because even in an endocrinology world, you have patients who who present initially with protect you know, presumably with Graves.

But as soon as the eye manifestation shows up, they wanna consult with ophthalmology. And so that’s where we think there’s 2,000 core prescribers in The US, which is a certainly a manageable number for for a company like us and a company like Horizon originally. The infrastructure we need to build to reach the core prescribers is certainly manageable.

Rich, Host, Goldman Sachs: Okay. Great. And then Amgen has also been saying that that The US the the total addressable market size is about a hundred thousand patients Mhmm. Of which eighty percent of those are chronic. However, they continue to say that they only have a a low single digit penetration into that market for MEPEZZA.

Steve Mahoney, Barivion: Why do you think chronic’s

Rich, Host, Goldman Sachs: so so difficult? It’s been been quite some time now since they they they did their phase four study. And and how is Viridian better positioned to address the chronic patients?

Steve Mahoney, Barivion: Yeah. And and first, I think we think the market’s actually bigger than a hundred thousand. You can see in our deck, we talk about more like a hundred and ninety thousand, closer to two hundred thousand patients with moderate to severe. We agree that the large proportion of those are gonna be more chronic, But that means there’s still also an incident population of roughly 20,000 new patients coming into that pool every year. And that is based on a number of different research.

But if with their single digit penetration that you referred to, you know, we we agree with that. We think that that number is small. Now their their ability to penetrate into chronic, it’s hard to say except for the fact that we think that there was more response that you could achieve in the chronic. And I think our data is differentiated on that. Again, it’s cross trial comparison, so you have to put the caveats on that.

But our chronic data is really compelling. I mean, if you look at our diplopia response, diplopia is double vision. If you look at our diplopia response and our diplopia complete resolution, so your double vision going away, that our numbers were really impressive. So we think that’s gonna drive better penetration to the chronic population. Again, our safety profile helps with that analysis as well.

The physicians we’ve talked to have been very excited about our chronic data. So we think that we can drive better penetration on that basis.

Rich, Host, Goldman Sachs: I see. And then looking at your data, do you believe that the same treatment regimen is needed for chronic compared to the active patients because their inflammation is less severe? I mean, I’m wondering if a shorter or a lower cost sort of treatment regimen more suitable to help encourage use and help penetrate the market a little bit better and maybe with a payer reimbursement.

Steve Mahoney, Barivion: Well, in fact, I think if you look at our chronic study, we you to get into the study, you have to have three millimeters of proptosis above normal. So by definition, these are proptotic patients walking in the door. They also we also ran, which was different than how TEPEZZA designed its studies, we clinical activity scores on a scale of zero to seven. TEPEZZA studies were limited to patients with zero or one. And these are, and clinical activity score is a proxy for pain and inflammation, redness, that crittiness that people feel in their eyes, by limiting it to zero or one like TEPEZZA did, by definition those are people who are not necessarily complaining about their pain.

When we ran our study, we had patients with zero or one, but we also had a number with higher CAS scores than that, which it indicates, clear indication that the chronic market has proptosis, has pain, has redness, and diplopia. I mean we had a large portion of our patients in the chronic study had diplopia at baseline. So these are people that are certainly symptomatic. And that’s why we designed the study that we did to make sure that we got the most representative population for chronic. Now we can have our chronic data in our label.

Just as a reminder, TEPEZZA does not have chronic data in its label. It’s got a broad indication statement, but not the data. And so we’re gonna have that on day one. We are the payers are fully aware of what IGF-1R inhibition can do now on the backs of TEPEZZA. And so we just think we’re in a better position to drive that penetration into the population.

Rich, Host, Goldman Sachs: Great. And then in May, you guys announced that you guys received a breakthrough designation from the FDA. How how beneficial do you think this is to maybe I mean, there’s a benefit to the the regulatory path, obviously, obviously, in terms of how the market’s gonna be perceiving value. By by getting that feedback from your your KOLs, clinicians being more on their radar and how how maybe tell me a little bit about the the awareness of that. And then what is the path for the breakthrough for the breakthrough definition for to the priority review?

Like, what do you have to do to get to that priority review?

Steve Mahoney, Barivion: Yeah, well I think, I think first and foremost, breakthrough therapy is a recognition by FDA that this is a serious condition. Right? I think that’s certainly true. And then what it does for us in terms of the benefits for us is obviously there’s a more formalized clear communication channel with FDA, although we were having great alignment and communication with FDA in any event. So that that that is one component of breakthrough.

The other component, which you referred to, is is the increasing your odds for priority review. They are distinct designations, but they’re based roughly on the same criteria. So you can’t ask for priority review until you file. We will when we file, we will put that request in. And, again, we think it has increased the chances of us getting priority review, which would be fantastic if we could pull in our launch timing.

And again, as I mentioned in the beginning, what breakthrough therapy is is a mechanism by which FDA actually compares your data to the standard of care. And for them to come out and say, we grant you designation, that is essentially indicating based on the definition of breakthrough that we represent a potential substantial improvement over currently available therapies. So a great a great place for us to land with our alignment with FDA.

Rich, Host, Goldman Sachs: Fantastic. And you guys show earlier you mentioned about this, that the positive long term durability study for data for the phase three THRIVE study. And I think there you showed about seventy percent of patients were able to maintain their proptosis response at week fifteen all the way through week fifty two. How do you how does this compare to the the long term data for TEPEZZA? And also, do you believe there’s a meaningful differentiation from a longer term durability perspective compared to TEPEZZA?

Steve Mahoney, Barivion: I don’t Sean.

Sean Wu, Barivion: Yeah. I can take that one. So as you mentioned, we showed really strong durability of response for patients at week fifteen who had a response. Seventy percent of those maintained their response at week fifty two, which was really good to see. The number that is in the TEPEZZA label is fifty three percent.

And so not making any cross trial comparisons, but we feel really good and confident about the number that we have reported on at week fifty two. Ultimately, at the end of the day, the question that was still remaining out there was whether VELI with the 70% less drug, five infusions or fewer infusions than TEPEZZA, whether the strong responses that we saw at week fifteen would continue. And I think we answered that with this data. And I think it’s durability numbers that we would expect to be in our label, which again is a very strong position for us at launch.

Rich, Host, Goldman Sachs: Great. And then how do you think about the patient who did not were not able to maintain their proptosis response to fifty two weeks? Any implication there for potentially a retreatment?

Sean Wu, Barivion: Yeah. It’s so just a reminder that the vast majority of patients did maintain their response. So we’re talking about a minority of patients. And this being an autoimmune disease that can have ups and downs and reactivation of the disease, as some of our KOLs refer to it. So it’s not unexpected to have some patients who don’t maintain that response.

We think retreatment is absolutely an opportunity. And based on real world data today, we do know of some patients that are getting retreated with the currently available IGF-1R. And the good news is they seem to respond again and KOL support retreatment. So that’s something that we will be exploring and looking at as a potential.

Rich, Host, Goldman Sachs: Okay. Fantastic. And in terms of belly stability in the chronic patients for the Thwype two, will you be showing that data as well when when that becomes available? And, also, how how are you guys looking at the expectation for that? Are you going to benchmark to that seventy percent in the active patients?

And is there any risk that the durability for the chronic may not be as robust compared to the active?

Steve Mahoney, Barivion: I think if you look at all the data we’ve put out to date, it’s completely consistent across endpoints, time points, durability time points, safety side, again breakthrough therapy, kind of a validation of all of that. So the antibody has answered every question all along the way. So whether we put we don’t have the Thrive two data follow-up period yet. We don’t have all that data yet. But we it is the last piece of the BLA.

So we will be scrambling to get that into the BLA so we can file as quickly as possible. So what our plans for whether we put that out or not, I don’t know if we need to. It’ll be in the BLA anyway. And maybe we’ll have it in the medical congress at some point. But I think we’ve answered the question on durability of response, whether the drug could actually do it or not given the amount of drug that we’re putting in.

But we’ll have the data eventually, and we’ll get it out in medical congress or it’ll just be in the BLA.

Rich, Host, Goldman Sachs: Fantastic. And then, obviously, I think for safety, I think this is important to to mention that you guys have a lower placebo adjusted hearing effect, a lower compared to TEPEZZA. How important is that? I mean, we talked about I mean, for the longest time, you guys talk talked about having five dose instead of eight would be a major differentiation. And having that sort of that slightly better lower hearing effects, How important do you think is that to to the clinicians when they’re looking deciding between treatment options?

Sean Wu, Barivion: Yeah. It we we do think it would be helpful as a part of the overall package of efficacy and safety that we’re delivering and, of course, the fewer infusions and shorter infusions that comes from VELI. It’s a benefit risk conversation that physicians will have with patients. When we first showed the data to some of our KOL advisors back when we reported on the phase three data, one of the things that they talked about was it makes the conversation that they have with the patients much easier Now that the available therapy has been on the market for five years, patients know this can be a side effect. And they go on Google.

They go on online forums. And they go in and ask their physician questions about hearing impairment as a potential AE. And so that is a conversation that many physicians are having with the patients. And so the fact that we can give them, the physicians, a chance to have an easier conversation, I think, is definitely helpful for our overall profile. A reminder that the overall hearing impairment, we’re not really talking about reductions in hearing function.

The vast majority of these are mild events like tinnitus, which is a ringing of the ears or hearing some echoing of one’s voice. And almost all of it resolves when the patient comes off of therapy as we also corroborated with our week 52 data. So this is a manageable risk profile for physicians. They’re very comfortable managing hearing impairment as a umbrella set of potential AEs. But anything that we can do to make it easier for them to have that benefit risk conversation with the patient would be better.

Rich, Host, Goldman Sachs: Great. And then I know we talked about The U. S. Commercial PrEP and how that’s ongoing. How do you think about Europe?

Is the plan to also file the the regulatory submission for for for EU sometime in 2026? Or and how is how you how are you thinking about commercializing VELI in in Europe?

Steve Mahoney, Barivion: Yeah. So we’re we’re trying to keep all our options open ex US, certainly. We think they’re from an epidemiology standpoint, Europe is certainly a viable market. We’ll be curious to see how pricing works. Obviously, that’s a key component to any European launch or commercial opportunity.

But we did guide that we would have our MAA filing in the first half of twenty twenty six. So we’re going to get the BLA in. We designed the Phase III studies in with Europe in mind as well, meaning we have an endpoint in there that the European regulators want to see, which is the overall response rate, which essentially is just your proptosis response and your clinical activity score combined. So we had that in our study to begin with, knowing that that’s what Europe would look for. So we’ll be ready to go.

We just need to switch from BLA into MAA once we get in. And then, and of course, we’re just watching how Europe develops in the meantime, and we’re just keeping our optionality open. We don’t have to spend any money for that optionality, which is always great. And then other parts of the world, the the normal markets like Japan, we’re looking at what we’re gonna do there as well. So we have all our options open.

And just a reminder, you know, TEPEZZA has been on the market now for five years, and they’re just finally going into Japan and Europe. Horizon was focused on The US. So we can we could skip we could skip the waiting period there and get those ex U. S. Revenues going as well.

Rich, Host, Goldman Sachs: So I know it’s maybe still a little too early to talk about pricing, but how are you guys approaching that? Obviously, you have a competitor that already has a price out there. Are you guys looking mostly you know, you have a different differentiated drug, and that looks better in many dimensions. And how are you guys looking at the pricing? Is it gonna be mostly parity?

Or what’s your approach to thinking about that?

Steve Mahoney, Barivion: Yeah. Well, first, is too early to talk about pricing. But yes, we are we’re looking at all of that. Obviously, we spent a lot of time, you know, with our market research and our talking to payers. We know what the we know what the current price is for TEPEZZA, and we are look I I think all we could say really at this point is we would probably price on a per course of therapy like they do.

But other than that, more to come later.

Rich, Host, Goldman Sachs: I see. And, also, the payer coverage. I think one one thing when we look across all the payers is that they all limit capacity to once per lifetime. There there are some retreatment possible for that. Maybe comment about, you know, how do you see the payers looking at another drug in this market?

What what’s important to them? And do you think they would loosen up at some point that once per lifetime for belly? And what do you need to do to show there?

Steve Mahoney, Barivion: Yeah. I mean, I think they’ll do that in response to data, as always. I think in terms of making progress with payers, TEPEZZA’s already doing that. They were, on the chronic setting, they got pushed back from payers because they did not have any chronic data at launch. They ran a chronic study eighteen months after approval, generated that data, it was available in 2023.

Like I said, they had a limited trial design with respect to particularly clinical activity scores, zero or one. But they’ve made progress. In their last call, they indicated that they had jumped from 55% commercial insurance coverage up to 85%, which is all good for us. Just as a reminder, this is all good for us. They’re they’re clearing clearing the way for us to come in and then and have a differentiated profile that we think would be more palatable to payers anyway.

So this is all good good lead work that they’re doing for us. And we think based on our market research and based on our talking to payers, we think we’re gonna be in a good spot.

Rich, Host, Goldman Sachs: Okay. So the VRDN003, the subcutaneous formulation, you have two ongoing phase three studies, data coming out next year. How are you thinking about what the expectation for that in terms of what do you need to achieve? Would are you benchmarking to Belly, like, know, to to Belly’s phase three study? Is that sort of the goal for o three?

Sean Wu, Barivion: Yeah. So we have both of those two ongoing studies as you mentioned. We think o zero three is a derisked approach given the data that we’ve generated with Phely back when we designed the REVEAL one, REVEAL two studies and the decision to take a Q4 weekly and Q8 weekly active dosing arms into that study, that was all based on being able to achieve similar exposures of BELI at ten mg per kg and three mgs per kg IV respectively. And that was both of those dosing arms show really great efficacy back in a phase two trial, which of course now ten mgs per kg IV, we’ve seen spectacular data from THRIVE and THRIVE two. So we think the efficacy and safety for three is the risk coming out of what we’ve seen for VELI, both from a efficacy standpoint and then to the extent that lower overall exposures, even Q4 weekly with a sub Q smoothing out Cmax, but in particular with Q8 weekly, be more at the exposure levels of three mgs per kg, to the extent these lower exposures can lead to an even better safety profile while preserving the efficacy of IGF-1Rs is a really exciting place to be for the three studies.

On exact expectation setting for those two studies, we haven’t gone come out and set that yet. But we do believe that everything we’ve generated with VELI IV and because the two molecules share CDRs have the same pharmacology, we will expect to behave similarly, interact with the target in the same way at the same exposure levels, we feel really good about the REVEAL one, REVEAL two studies.

Rich, Host, Goldman Sachs: Got it. So you haven’t set expectations, but when we I how should the market look at this? Is it does it have to be as good as belly? Or if it comes slightly below that for efficacy, is there still value in that?

Sean Wu, Barivion: Yeah. I think the way that we look at it is it’s providing more options for patients. A subcu option, whether it’s q four or q eight, both of those would be best in class regimens for subcutaneous. There’s nothing out there that we know of that is that infrequent and is auto injector that would be mailed to a patient’s home. And at the end of the day, either one of those two options would be great for patients, and we give them a range of options, including IV valigretag as something that they can choose from.

Rich, Host, Goldman Sachs: Great. And then looking at the both the q four w and the q eight w dosing regimen, is is the the plan to take both to commercial? How are you guys gonna decide between both of these going forward?

Sean Wu, Barivion: Yeah. We’ll we’ll definitely need to look at the data before making that decision of how we take things forward. But, again, as we said, either one of these would be fantastic regimens for patients, and it comes down to what the safety and efficacy data shows from the trial. So we’ll make decisions accordingly based on that.

Rich, Host, Goldman Sachs: Okay. Great. And then for o ’3, are you guys committed to launching it with an auto injector? And then how how is that portion of the development going for for o ’3?

Sean Wu, Barivion: Yeah. It’s going really well. Everything is on track as we guided to a top line data first half of next year with a BLA submission anticipated by the end of the year. That BLA submission would be with an auto injector. So all of that has been worked into the timelines for BLA.

Rich, Host, Goldman Sachs: Fantastic. One last question before I turn it to you guys for closing remarks. Anything in the competitive landscape that you guys are still tracking for in in PET? Obviously, I think there’s a lot of competitors that released data over the past year, and a lot of them have have been been disappointed. And and is there anything else that you guys are tracking?

Anything else that you think could could be worth look looking more into?

Steve Mahoney, Barivion: No. It’s a it’s a good question. Mean, I think that was one of the big overarching questions last year is what about the competitive landscape? The competitive landscape has really cleaned up really nicely in our favor. As you mentioned, there’s been a number of companies that have had data that didn’t look all that compelling versus what we’ve been able to offer.

And again, when we look at it’s a cross trial comparison, but when we look at our different profiles in a new start market, I mean, that’s the key here. We’re not asking anybody to switch when it’s just us and TEPEZZA. We think we’re not asking people to switch off TEPEZZA to try us. These are everyone comes in the door and we get they’ll have options with respect to our drug versus TEPEZZA. And we think we’re in a good position there.

But the rest of the competitive landscape, I think there’s either a recognition that the other attempts at IGF-1R inhibition were not that compelling, and then the other mechanisms are not particularly on target. You have broad anti inflammatories, you have broad IgG suppression. We just don’t think that that’s on target for the cell signaling that’s taking place for moderate to severe patients with TED. So the competitive landscape is cleaned up quite nicely for us.

Rich, Host, Goldman Sachs: Well, Steve, Sean, it’s been a pleasure hosting you for the second time at the Goldman Sachs conference. Thank you so much for attending, and I I wanna turn it to you for any final conclude concluding remarks.

Steve Mahoney, Barivion: Yeah. Sure. Look. I I bottom line, we have derisked programs, validated mechanisms, clinically validated, commercially validated mechanisms, which is our approach. We like to try to make things better and easier for patients versus what the first entrant.

And so all of that is on track. We’re executing across the portfolio. And we just continue to march along and keep derisking these programs even further. And everything is on track for we’re going be a commercial company next year. I think that’s a pretty exciting prospect.

Sean Wu, Barivion: And we’re continuing to advance our FCRM portfolio as well, which very much fits into that derisked and exciting development path for a derisked market.

Rich, Host, Goldman Sachs: Great. Thank you.

Steve Mahoney, Barivion: Great. Thanks, Rich.

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