Viridian Therapeutics at Stifel 2025: Strategic Moves in TED Market

On Wednesday, 12 November 2025, Viridian Therapeutics (NASDAQ:VRDN) presented at the Stifel 2025 Healthcare Conference, offering a strategic overview of its advancements in thyroid eye disease (TED) treatments and its FCRN portfolio. CEO Steve Mahoney highlighted the company's recent BLA submission for veligrotug, while outlining the path to potential market entry by mid-2026. The company emphasized its robust financial position and readiness to launch, despite competitive pressures from existing market players.

Key Takeaways

• Viridian submitted a BLA for veligrotug IV, targeting a mid-2026 launch.
• The U.S. TED market is valued at $2 billion annually, dominated by Amgen's Tepezza.
• Viridian is well-capitalized with a recent DRI royalty deal and equity follow-on.
• The company is preparing its commercial organization for a new therapy launch.
• Viridian's FCRN portfolio shows promise, with VRDN-006 and VRDN-008 in development.

Financial Results

• Viridian has secured a significant DRI royalty financing deal, the largest DRI has conducted.
• The company anticipates reaching profitability, irrespective of the FDA review outcome.
• The royalty rate will decrease after reaching a $600 million threshold.

Operational Updates

• Enrollment for pivotal studies of veligrotug's subcutaneous version is complete, with data expected in Q1 and Q2 2026.
• The company highlights dosing advantages of veligrotug, requiring fewer infusions than Tepezza.
• Viridian is actively engaging with key opinion leaders (KOLs) and building its commercial infrastructure.

Future Outlook

• Viridian is entering a "new start" market for TED treatments, not a switch market.
• The company is optimistic about the rapid adoption of its therapy due to the concentrated prescriber base.
• The FCRN portfolio's strategic landscape includes exploring validated and new indications, with a focus on low-cost optionality.

Q&A Highlights

• CEO Steve Mahoney emphasized the importance of breakthrough therapy designation in a competitive market.
• CCO Tony Castianos noted the $2 billion annual market size, driven by Tepezza's growth.
• The company is turning towards becoming a commercial entity, highlighting its readiness for market entry.

For a detailed understanding, please refer to the full conference call transcript below.

Full transcript - Stifel 2025 Healthcare Conference:

Alex Thompson, Biotech Analyst, Stifel: Good morning, everyone. I'm Alex Thompson, a biotech analyst here at Stifel. Happy to have the Viridian Therapeutics team here with us this morning: Steve Mahoney, CEO, Tony Castianos, Chief Commercial Officer, and Shan Wu, Chief Business Officer. Maybe to start things off, I'll hand it over to you, Steve, to give a brief overview of the company, and then we'll get into a Q&A.

Steve Mahoney, CEO, Viridian Therapeutics: Okay, great. Thanks, Alex. Thanks to Stifel for having us here today. As you may know, we are advancing an autoimmune portfolio. Our first program is in thyroid eye disease, which is roughly in a growing $2 billion market in the United States alone. There's just one competitor on the market. We just recently submitted our BLA. We did that despite the government shutdown. The FDA was particularly helpful in helping us navigate through that. Our BLA has been submitted on the backs of our phase three data that came out towards the end of last year. The phase three data was quite robust and good in terms of its responses on the endpoints that we measure. Proptosis: in thyroid eye disease, these patients have proptosis, which is a bulging of the eyes.

They have diplopia, which is double vision, and there's quite a bit of pain and inflammation associated with the disease. It can be disfiguring. It can have a lot of impact on people's abilities to live their normal life, considering how they perceive how they look. Even with double vision, how do you drive? How do you read? How do you work? This is primarily women in their 40s and 50s who are impacted by this disease. Quite a bit of patient impact to take into account, which is why we're so excited about our data. We had very good proptosis response in terms of reducing proptosis. We had resolution, we had response in diplopia, meaning improvement, but we also had very good numbers with respect to resolution of diplopia, meaning double vision goes away and they can actually return to function.

Quite a good impact on pain and inflammation as well. We ran our pivotal studies, had the top-line readouts and durability readout over the course of the past year. We got breakthrough therapy designation for this drug. That is obviously very critical given the fact that there is an existing marketed product that has the same target, IGF1R. To get breakthrough therapy designation was important. It is something that we believe will help increase our odds quite significantly with respect to possibly getting priority review now that our BLA has been submitted. There is a 60-day window in which the FDA will decide on whether we can get priority review, which essentially would put us in a launch timeframe of mid-2026. As you can tell, we are on the backs of great data, breakthrough therapy designation, the possibility of priority review timeline.

We are turning the corner towards a commercial company. That's all very exciting. That's all in our IV version of the product. We took the same antibody, engineered half-life extension into it, and formulated it for subcutaneous as well. We just recently announced in September that we had completed enrollment in our pivotal studies for the subcutaneous program. We will have the top-line readout of the active form of the disease in Q1 2026, and then the chronic in Q2. Just again, it's the same antibody, same CDRs, binding domain. We expect it to behave very similarly to the IV. Again, formulated for a 2 mL at-home autoinjector pen, same pen that's used in Dupixent and a number of other autoinjector pens for self-administration. That's a really exciting program as well. Again, we've finished enrollment and we're moving towards those top-line readouts.

We think the market impact of not just the IV program coming in, and this is a critical component of the commercial landscape, Tony can get into it, but we're going into a new start market. This is not a switch market. We don't have to go in and convince anyone to come off of some sort of chronic or lifetime therapy. We're simply going in and we're going to be a new treatment option for these patients. This is sizable markets that we're talking about. There are 500,000 people in the United States alone that have thyroid eye disease, 200,000 of which have moderate to severe form. There's an incident rate built into that. The market is ripe for additional options like ours. The thyroid eye disease program is full steam ahead. We've beat all our timelines. We've over-enrolled these studies.

We think there's a great deal of enthusiasm in the market for our products, and we expect to expand the market significantly when we get there. We also have a portfolio in FCRN where we have our lead program in 006 is an FC fragment. We believe it's the only other fragment in clinical development. As you may know, in that market, Vyvgart is a fragment, and it's obviously the gold standard and done very, very well and made a big impact on patient lives. We think we're looking at ways that we can help with that. With that first program, we've put out healthy volunteer data saying that we are consistent with the IgG suppression and albumin sparing profile that you need in that class. That's very exciting. We've got a second program in FCRN. It's a half-life extended approach.

We're on track for filing the IND at the end of this year. We'll get healthy volunteer data in that half-life extended approach next year. That obviously would be quite impactful as well given the frequency in which FCRNs are dosed. We're off to the races. We're really well-capitalized. There you go.

Alex Thompson, Biotech Analyst, Stifel: Do you want me to keep talking?

No, I like hearing you talk. Let's keep going. Maybe you alluded to the TED market. Maybe, Tony, if you want to talk a little about what does the current TED market landscape look like? What have we seen in terms of Tepezza adoption? Where does it stand today? What are really the key opportunities that you're looking to launch into next year?

Tony Castianos, Chief Commercial Officer, Viridian Therapeutics: Yeah, absolutely. Just to kind of reset, the TED landscape in the U.S., roughly 500,000 patients from a prevalence perspective. 200,000 of those patients are moderate to severe, so they would be considered IGF1R appropriate. One approved product that's being marketed today by Amgen, Tepezza has been mentioned a couple of times. That is an IGF1R targeted product. It has recently returned to growth. We're happy to see a couple of quarters up over $500 million. The last quarter, $560 million. Really good to see a return to growth by that product. Annualizes out to about $2 billion. This was a product that was launched by Horizon with roughly 50 reps, grew quickly to roughly 80 reps from there after, and they raced off to $800 million in sales in the first year, and then grew it to this $2 billion market that we see today.

Of that $2 billion, that represents roughly 7,500 patients on an annual basis that are receiving Tepezza. As Steve mentioned, those are new patients every year. It's a new start market. No chronic delivery of IGF1R for TED patients to date. These are patients that are regenerative every year. Another 7,500 will start on Tepezza as of last year, this year, most likely next year as well, barring any additional growth. A couple of things to point out in this market that have us very excited from a commercialization perspective. One, Steve mentioned, this new start market does lend itself to rapid adoption of a new therapy. We're not having to switch any patients off of existing therapy when we enter the market pending Veli approval.

The second is the concentration of this market is such that most of the 7,500 patients are being treated by roughly 2,000 core prescribers. What does that mean to us? That means that you can address that physician group with a fairly tight commercial infrastructure. Couple that with, again, the rapid growth of this class post-launch by Horizon. We believe it's highly impactable. Concentrated and impactable are two really good inputs into our confidence and our ability to launch this product well, possibly middle of next year, as Steve mentioned.

Alex Thompson, Biotech Analyst, Stifel: I think the way that I want to approach talking about the phase three data from the THRIVE program is really, when you think about the potential label for veligrotug, can you talk through, I do not know if Steve or Shan, kind of what the differentiators are when you are potentially pitching this drug to a physician and a patient here? What are the key differentiators that you expect to see on the label? Tony, address that based on your phase three program.

Tony Castianos, Chief Commercial Officer, Viridian Therapeutics: Yeah, absolutely. One of the things that we've learned by studying this market extensively is there's absolutely room for growth. That's inherent in the 7,500 out of the 200,000 are currently getting therapy. As we talk about where is the unmet need, we feel like we are uniquely designed as a drug and uniquely equipped to address those. Those are three things primarily. One, I would actually mention that the totality of the profile is what has us so excited. If we're going to pick on three individual attributes that give us the most excitement, the first is the obvious one, and that's the dosing differences. Five infusions given three weeks apart, 30-45 minutes each infusion, versus Tepezza. Tepezza, eight infusions three weeks apart, 60-90 minutes each time on the chair.

Just to drive that home and give you the practical kind of benefit for patients and physicians from that, you're talking about Tepezza taking, if you're doing it right, a minimum of 21 weeks. With Veli, if approved, you're looking at roughly three months. You're finishing your therapy a lot sooner. Combine that with the fact that onset of action is something that we are extremely excited about. Just to remind you, in our phase three trial, we saw Veli deliver statistically significant proptosis response in the majority of patients after just one infusion at the three-week time point. Again, this is a patient population who is living an active life. Most of them are working-age females. If you're lucky enough to live next to an infusion center, that's great.

It's still a lot to ask from a therapy perspective, eight infusions over up to five months, over five months. You also want to get resolution of your symptoms as fast as humanly possible. We see that three-week endpoint as being very impactful to physicians, very impactful to patients as well. Just to restate, the dosing differences, the onset of the efficacy, and then the completion of therapy as well. Last point, third point. We were able to see really compelling data in our chronic patient population, in our chronic registrational trial, where we saw not just a diplopia impact and effect resolution, but complete resolution as well in a good number of patients. That's different than what we see in the Tepezza label. Importantly, this will be information and data that will be in our label at launch.

We anticipate to launch with both active and chronic data in our label. As a reminder, Tepezza launched with just the active data in their label, and then sometime later conducted a phase four trial to add the chronic data. We think that gives us a compelling argument with physicians and also with payers to secure broad coverage shortly after launch.

Alex Thompson, Biotech Analyst, Stifel: From a mechanics perspective, the time in the chair, is that a benefit from an infusion center perspective? How does that help you potentially position yourselves versus Tepezza?

Tony Castianos, Chief Commercial Officer, Viridian Therapeutics: Yeah, good question. Absolutely. A lot of these busy infusion centers, their business model is getting patients in and out quickly. We believe that a 30-45 minute time in the infusion chair versus a 60-90 minute could be compelling to some infusion centers. I would just remind everybody that infusion centers aren't making the decision on treatment in this marketplace. That's an important dynamic to remember. Physicians drive treatment choice. Most of the infusing is happening at infusion centers. We think that's an important consideration to keep in mind as you think about the transition of this market from IV to subcu, where in some traditional buy-and-bill infused categories, there's some stickiness financially where physicians have economic incentives to stick with the IV. That's not the case in this market with most of it happening at the infusion center.

Alex Thompson, Biotech Analyst, Stifel: Maybe where are you at in terms of Salesforce build and general launch prep heading into next year?

Tony Castianos, Chief Commercial Officer, Viridian Therapeutics: Yeah, so as Steve mentioned, we are optimistic about the possibility of a priority review. We are planning our commercial buildout in alignment with that review timeline. We will be ready if approved in alignment with the priority review. We are actively building out not just the Salesforce, but all of the foundational elements of the commercial organization: market access, patient services, Salesforce as well. We have leadership in place already across each of those. We are actually also very active already from a medical affairs perspective with a field medical team that has been in place out in the marketplace, engaging with KOLs. In fact, over 500 engagements in October alone across the medical congresses. Very active, yeah.

Alex Thompson, Biotech Analyst, Stifel: Maybe shifting gears to 003 and upcoming phase three data. Steve mentioned about OXIDA's antibody shares a binding domain of veligrotug with Fc modifications. You have not yet run, you've never run a proof of concept TED study for 003. What gives you confidence in sort of the phase one PK matching that really drove the dose selection for phase three?

Steve Mahoney, CEO, Viridian Therapeutics: Yeah, I'll answer that question.

Shan Wu, Chief Business Officer, Viridian Therapeutics: Yeah, that's a great question, Alex. Going back to the design of 003, as Steve talked about, it is a very, it has the same binding domain, has the same CDRs, it interacts with the target in the same way. More than any other IV to subcu conversion, so to speak, we think that 003 is exceedingly de-risked from an efficacy standpoint. When we first designed that molecule, once we formulated it, we tested it in healthy volunteers in a phase one study, and that is the basis for the PK of the molecule, which is extended. The half-life is about 40-50 days, much longer than veligrotug. With that, we were able to model what different dosing regimens of 003 could achieve from an exposure standpoint.

In those exposures, we were able to match back to what exposures had already been seen with veligrotug in TED patients that was very clinically active. At the time, that data was based on Veli IV data in a phase two study where we looked at 3 mg per kg, 10 mg per kg, and also 20 mg per kg IV Veli. The 003 dosing regimens that we modeled, Q4 weekly of 003, the CMINs there were able to match back to the Veli IV 10 mg per kg. The Q8 weekly were able to match back CMIN-wise to 3 mg per kg IV and actually exceeded the CMINs for 3 mg per kg IV. We believe the CMINs drive efficacy for antagonistic antibodies.

That gives us the confidence that we are at exposure levels with both Q4 weekly and Q8 weekly that are within that range of being therapeutic to have the level of efficacy, strong efficacy that physicians and patients have come to expect for IGF1Rs. On the other PK parameters, both the CMAX and AUC, which we modeled as C average, were lower than the Veli IV 10 mg per kg and 3 mg per kg. We think this is a good thing to the extent that CMAX or AUC might be driving of safety. We think both Q4 weekly and Q8 weekly 003 could lead to an even better safety profile.

Alex Thompson, Biotech Analyst, Stifel: Do you also want to mention the PD side of the healthy volunteer study where we saw increased levels of IGF1, which is what you want to see?

Shan Wu, Chief Business Officer, Viridian Therapeutics: Yeah, on the PD side, this was a really good another data point on the validation of 003 and Veli, we believe will interact similarly with the target. On the PD side, the PD biomarker in this space is levels of IGF1. We would expect levels of IGF1 to increase in serum once the IGF1 receptor is inhibited. What we saw in that early study with 003 is that we were getting to the same levels, about 4x increase in IGF1 levels, which is around the same levels as IGF1 increases with Veli. That is reflective of both of these being full antagonist antibodies for the IGF1 receptor.

Alex Thompson, Biotech Analyst, Stifel: Then in terms of your learnings from the THRIVE program and applications to the REVEAL program, what are the key similarities and differences across those phase threes? And how would you set up the expectations?

Steve Mahoney, CEO, Viridian Therapeutics: I think I'll just start. Sorry. The inclusion and exclusion criteria are very similar. The site selection, very similar. A lot of overlap, a lot of PI and sub-I experience, a lot of relationships that we've built over the past several years with those sites, familiarity with the profile protocol. I think that you can see the results with respect to our enrollment curves have been very good. You saw in REVEAL-1, which is the active population, 67% of those were enrolled in the United States. Those are people choosing to go into a placebo-controlled study in spite of the fact that Tepezza is on the market and commercially available. We think that's a really good sign in terms of physician engagement. We saw 56% in the REVEAL-2 study in the United States.

Again, these are really key metrics for what we think is a great setup for the commercial story as we unfold. Anything else to add to that, Shan?

Shan Wu, Chief Business Officer, Viridian Therapeutics: The primary endpoint for REVEAL-1 and REVEAL-2 is at 24 weeks. In that way, actually, patients are getting a longer exposure to an IGF1R. We think that is additionally advantageous for the trial in terms of from an efficacy standpoint. One final comment to make is Steve talked about inclusion and exclusion being similar and actually designed exactly the way that we did for THRIVE and THRIVE-2. I want to point out that on the chronic side, so REVEAL-2 study, we similarly also included the full spectrum of chronic patients regardless of their CAS score. This is another robust and representative inclusion of chronic patients because we know many of these chronic patients also do have high CAS, and we're including those patients in the REVEAL-2 study as well.

Steve Mahoney, CEO, Viridian Therapeutics: I think what's also interesting too is if you look at THRIVE, THRIVE-2, REVEAL-1, REVEAL-2, these are the four largest studies that have ever been run at this stage in TED. I think the robustness of our data with respect to in THRIVE and THRIVE-2, you saw the consistency on the endpoints and the time points. The curves are super clean, which is why we're really excited about our FDA interactions.

Alex Thompson, Biotech Analyst, Stifel: In terms of what does a good outcome look like, should we expect at least the Q4 week dose to look like veligrotug? Is that how we should think about the bar? How do you want to frame that?

Shan Wu, Chief Business Officer, Viridian Therapeutics: Yeah, the bar for success is what has been set as from an efficacy standpoint, what has been set by Tepezza, which is a high bar for IGF1R and the efficacy associated with IGF1R. If you go back to the Tepezza studies, their pivotal studies, they ran two pivotal studies in active TED. There is a range of proptosis response on a placebo-adjusted basis that ranges 51%-73%. That creates a pretty nice clear bar for efficacy success for 003. We think with 003, if the efficacy is anywhere in that range, it will be a compelling product. It will have reached that bar of the high efficacy that physicians have come to expect. As we talked about before, we could see even better safety because of the lower overall exposures and CMAX that the subcu smooths out.

Alex Thompson, Biotech Analyst, Stifel: Great. I want to spend some time in the last seven minutes or so here on the FCRN franchise. I think the question here is there's a lot of potential for FCRN. And where do you see yourself fitting into that landscape from both best in class across indications that are validated versus new indications? How do you think about the strategic landscape in FCRN?

Shan Wu, Chief Business Officer, Viridian Therapeutics: I think all of those are options for us. The way that we see it is there are very large and exceedingly validated indications where FCRN has already been approved. Myasthenia gravis, CIDP being two of those examples. These are projected to be over $10 billion in total market size and not that far from now in 2030 are the latest projections that I've seen. These are really large markets. We have two programs, 006 being the only fragment that's in development besides Vyvgart, and then 008, which we think could be the game changer given its half-life extension that really could improve on the dosing regimens for these patients and bring down the frequency of how many doses these patients are getting. Both of these could compete very well in this very large market.

You have dozens of additional indications where FCRN has a scientific rationale that we are seeing others conduct trials in these new indications. Even beyond the ones that are in clinical development now, there are even more that is a long tail of FCRN-indicated or implicated indications that are options for us as well. All of that is on the table. We have our thoughts on how we would develop 006 and 008 and the interplay between the two within our own FCRN portfolio. I think we'll come out at the right time and talk about that with the public. It is really exciting to be able to have these two molecules in our portfolio with the number of options that we have. Both of these are relatively early. We're not spending a lot of capital on these either.

We call them low-cost optionality for us for the FCRN portfolio at this point.

Alex Thompson, Biotech Analyst, Stifel: I guess at this point, do you see yourself moving forward in phase two and beyond with both 006 and 008? I mean, we're not that far from 008 phase one data.

Steve Mahoney, CEO, Viridian Therapeutics: Right. I mean, I think that's the key. I think that goes nicely with what Shan just mentioned with respect to low-cost optionality. We're running healthy volunteer studies. We want to see what those profiles look like. At a certain level, the FCRN world can be simplified to IgG suppression levels and whether you're albumin sparing. You don't see those LDL spikes. So far, so good on 006. That looks like it's supposed to. 006, again, is that fragment. The only other fragment other than Vyvgart that we know of that's in development. We like that setup. That 006 study technically is still ongoing. We've got to see that finish out. 008 is gearing up, and we're going to see that data as well. We like that optionality. We want to see what these profiles look like.

As Shan indicated, there's no reason for us to come out and start picking indications. We've done the work internally, but we're not going to start. It is a competitive world. We think the full-length antibodies, there's definitely meat on the table there. We want to be in a position to take advantage.

Alex Thompson, Biotech Analyst, Stifel: I want to spend the last couple of minutes now talking about your financial position. Maybe the first question is you recently announced your DRI royalty deal. Can you talk a little about the rationale for doing that deal and whether or not you view that as encumbering veligrotug and 003 in any way from a strategic perspective?

Steve Mahoney, CEO, Viridian Therapeutics: I'll answer the second question first. No. It does not encumber us. We wouldn't have done the deal if we felt it was going to be encumbering from that perspective strategically, as you mentioned. No, we wouldn't have done the deal that way. The royalty financing, it's a great, I'd say first, it's a great validation of our business. For those who have been through royalty structures or synthetic royalties like we have, it's a massive due diligence effort. It's M&A level diligence. They spent months looking at us and turning us upside down, which we love. We're more than ready to do that. That turned out great. I mean, I think that was the largest deal DRI had ever done. It's a great setup for us in terms of the upfront cash, but then the milestones that we fully expect to achieve in any event.

It's a really good financing vehicle for us to keep ourselves well capitalized. We were able to do the equity follow-on the following week, which just further solidifies us. The combination of all these things with our existing cash, with the DRI deal, with the equity follow-on, with the fact that we're turning the corner to commercial, we are now in a position to say that we expect to be at break-even. We're going to reach, we expect to be able to reach profitability on this basis. That's regardless of whether we get priority review or we get standard review in FDA. We're really well situated from a capital perspective.

Alex Thompson, Biotech Analyst, Stifel: I guess from the profitability break-even perspective, what does that assume in terms of investment in the FCRN business versus the TED business from here?

Steve Mahoney, CEO, Viridian Therapeutics: Yeah. I mean, Tony referenced the revenues that Horizon was able to do in its first year post-launch. Not that we're guiding to revenue.

Alex Thompson, Biotech Analyst, Stifel: Yeah, I was going to ask about that. Is $800 million the bar for Horizon?

Steve Mahoney, CEO, Viridian Therapeutics: No, we're not guiding to revenues at this point, obviously. You can imagine that if as our revenue ramp picks up with both Veli and then subq, we can fit a lot of development costs underneath that, we think. That's where it comes from.

Alex Thompson, Biotech Analyst, Stifel: Okay. For the DRI deal, how competitive was the royalty financing process from other players in the field? Can you talk about your ability to get out of that deal?

Steve Mahoney, CEO, Viridian Therapeutics: Yeah. No, that's a good point, actually. Thanks for that question. Yeah, all the royalty players were at the table. It was a competitive process. We were able to, as you can see in our 8K when we announced that deal, there is a cap that we can reach if we hit certain conditions, which we obviously feel that we're certainly capable of. That is a really nice component to that deal versus some of the other deals that you see out there. You can see the royalty rate drops off quite a bit after we hit a certain $600 million in threshold. It drops down quite a bit. It is not going to be prohibitively on our ability to operate, but we can also reach that cap. Yeah, we think we got a really good deal.

I think DRI also feels like they got a really good deal. It is a good situation.

Alex Thompson, Biotech Analyst, Stifel: Great. Steve, Tony, Shan, thank you so much.

Shan Wu, Chief Business Officer, Viridian Therapeutics: Thank you.

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