Viridian Therapeutics (NASDAQ:VRDN) reported third-quarter financial results on Wednesday. The transcript from the company’s third-quarter earnings call has been provided below.

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View the webcast at https://events.q4inc.com/attendee/599668655

Summary

Viridian Therapeutics reported $24.7 million in net product revenue from the launch of Lynvoa for thyroid eye disease, exceeding expectations with over 100 patients on therapy.

The company is progressing with strategic initiatives, including the upcoming BLA submission for Allegribart in Q1 2027 and the initiation of a Phase 1 trial for VRDN-292 in Graves’ disease patients.

Viridian has made significant progress in securing payer coverage for Lynvoa, achieving 30% coverage by the end of Q3 and remaining on track to achieve broad coverage within six to nine months.

The company maintains a strong financial position with over $955 million in cash and equivalents, supporting its plans through profitability.

Management expressed confidence in the sustainability of Lynvoa’s market penetration and highlighted the potential for future growth with upcoming pipeline developments.

Full Transcript

OPERATOR

A question-and-answer session and instructions will be given at that time. As a reminder, this conference call is being recorded. I will now hand the call over to Greg Racino, Senior Director of Investor Relations at Viridian. Please go ahead.

Greg Racino (Senior Director of Investor Relations)

Thank you, operator, and good morning, everyone. Thank you for joining us to discuss Viridian’s third quarter 2026 financial results and recent business updates. You can access the press release and the slides for today’s call on the Investors page of our corporate website at viridiantherapeutics.com. Before we begin, I’d like to remind everyone that today’s call and webcast will contain forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. A description of these risks can be found in the forward-looking statements disclaimer in the press release and slides issued today as well as our SEC filings, including our quarterly report on Form 10-Q. With me today are Steve Mahoney, our President and Chief Executive Officer, Tony Casciano, our Chief Commercial Officer, and Seth Harmon, our Chief Financial Officer. Sean Wu, our Chief Business Officer, will join us for Q&A. With that, I’ll turn the call over to Steve.

Steve Mahoney (President and Chief Executive Officer)

Thanks, Greg. Good morning, everyone. Thank you for joining us to discuss the results from our first quarter of Lynvoa launch in thyroid eye disease. As spelled out in our earnings release earlier this morning, it has been a very strong start and the Viridian team has done another excellent job executing across the board. Lynvoa generated $24.7 million in net product revenue, and we had more than 100 patients on therapy as of September 30th. This is a very encouraging start to the launch and certainly has exceeded expectations.

It is still early in the launch cycle, but we believe these results are a testament to Lynvoa’s compelling product profile and the readiness and execution of our entire organization since day one of launch. Before we provide more color on the Lynvoa launch, I want to highlight the emerging Viridian pipeline, which we believe will drive the next chapter of Viridian’s growth in autoimmune diseases. First, we’re on track to submit our BLA for Allegribart in the first quarter of 2027. Ellie is our next-generation subcutaneous anti–IGF-1R. Based on our Phase 3 results, Ellie has the potential to further improve the TED patient experience, and we believe that it will encourage more patients to seek treatment with at-home self-administration as infrequently as every eight weeks.

Later this quarter, we also look forward to sharing first-in-human results for VRDN-008. 008 is a half-life extended FcRn inhibitor and is another example of a product candidate designed to reduce treatment burden with less frequent dosing while also providing sustained disease control. We’re also making strong progress with our anti-TSHR product candidate, now called VRDN-292, which we believe has the potential to be best in class. We expect to initiate a Phase 1 clinical trial with VRDN-292 in Graves’ patients later this quarter.

Together, these programs represent the future for Viridian, building a leadership position in TED and expanding our portfolio across other autoimmune diseases. With that, I’ll turn it over to Tony to walk through the Lynvoa launch.

Tony Casciano (Chief Commercial Officer)

Thanks, Steve, and good morning, everyone. It’s been incredibly rewarding for our team to bring Lynvoa to patients with TED, and I’m proud of the start we’ve had. I’ll start with a quick reminder of the market and Lynvoa’s profile, and then walk through the quarter and where we go from here. Let’s start with the patients. As a reminder, TED is an autoimmune condition that mostly affects women aged 40 to 50 with families, jobs, and active lives. TED causes inflammation, tissue expansion, and damage around the eyes. These cause disfiguring and debilitating symptoms that affect how patients function every day. The most severe cases can be sight-threatening. TED is also a large, established market where the first approved therapy generates roughly $2 billion in annual revenue but represents roughly single-digit penetration of the overall TED market.

The TED prescriber base is highly concentrated, with roughly 2,000 core prescribers writing more than 80% of IGF-1R scripts. These physicians are experienced treating TED, they have established referral pathways, and they know how to coordinate with infusion centers. That allows us to reach the market efficiently with a focused field team, and TED is a new-start market. Every time a TED patient seeks treatment, there’s an opportunity for Lynvoa to be chosen.

That’s where Lynvoa comes in. Lynvoa has a compelling product profile that we believe is aligned to unmet needs in TED. In our clinical trials, Lynvoa demonstrated robust improvements in both proptosis and diplopia for patients with both active and chronic TED. These improvements happen rapidly, with patients experiencing meaningful reductions in proptosis in as early as three weeks. We believe this combination of rapid, robust, and durable benefit is a compelling profile for TED patients.

Furthermore, Lynvoa delivers those benefits with a short 12-week course of therapy in just five infusions, allowing patients to complete treatment quickly and get back to their active lives. Early feedback is that this profile is resonating with patients and physicians, and that enthusiasm is already translating into meaningful launch momentum. And with that backdrop, let’s look at the quarter. As Steve said, the first quarter of Lynvoa launch exceeded expectations. We believe this strong start is driven by Lynvoa’s compelling product profile and years of preparation and strong execution by the Viridian team. When we announced Lynvoa approval, we discussed the early launch indicators. We were focused on field execution, payer coverage, and demand, and we’re making strong progress on all three in the early days of this launch.

We said at launch that our first priority would be rapidly engaging the core physicians who treat TED and prescribe IGF-1R, and we did just that. Our reps were fully trained and in the field talking to physicians about Lynvoa within 24 hours of approval. We have a highly experienced team with a track record across multiple launches, including buy-and-bill products. The relationships this team built ahead of approval with the core prescribers allowed us to hit the ground running and drive the broad engagement we’ve been able to secure with KOLs and prescribers.

As expected, this team is executing at an extremely high level in the early stages of launch. Another top priority is market access. We said we would build on the foundation we established with payers during our pre-approval work to rapidly secure payer coverage post-approval, and we’re doing exactly that. In Q3 we completed post-approval presentations with all major payers. This represents more than 90% of covered lives in the U.S. We’ve made significant progress on our payer coverage and are on track to achieve broad coverage for Lynvoa, and on our estimated timeline of six to nine months from launch.

We moved quickly to apply for a permanent J-code following approval and are pleased to announce that CMS has now assigned one for Lynvoa, which will become effective on January 1, 2027. Yet another example of the team being prepared and knowing how to navigate this market. This execution across the board, in conjunction with the compelling Lynvoa profile, is translating into strong early demand for Lynvoa. More than 100 patients were being treated with Lynvoa at the end of the quarter. To be clear, these aren’t enrollment forms. These are more than 100 patients who started treatment with Lynvoa and had completed at least one infusion by the end of the quarter. This demand drove $24.7 million in net product revenue for our first quarter of launch.

We are extremely proud of this start and of strong execution across our stated launch priorities, but we also recognize it’s still early and there’s more work to do. The Viridian team is firing on all cylinders and focused on building on this momentum. Our launch priorities haven’t changed: Drive Awareness, Differentiate Lynvoa, and Deliver Access. As we said at approval, in the early quarters that means engaging prescribers, moving patients through the treatment journey, building coverage, and delivering great experiences through Viridian Cares. That’s where we’re focused in the fourth quarter and beyond. With prescribers, we’re focused on continuing to educate on Lynvoa’s clinical data and compelling profile and ensuring that they are fully supported by Viridian.

We’ve already seen both breadth and depth in prescribing, and we will continue to focus on driving both. Our market access team has been successfully engaging with payers both pre- and post-launch to drive policy coverage for Lynvoa and facilitate patient access. As we have stated, policy adoption takes time after product approval, and payers often have different timelines for decision making. The team has made excellent progress on this front and will continue to expand from here.

With respect to patients, Viridian Cares, which is our patient support services team, continues to be critical to launch. Viridian Cares has been focused on facilitating treatment initiation by supporting patients, physician offices, and infusion centers from enrollment throughout the treatment journey. We are focused on continuing to provide great experiences for every patient and physician, and on setting a standard for what they can expect from Viridian’s world-class patient services, which is anchored by our experienced and extremely capable Patient Access Liaison team.

Overall, this was an exceptional first quarter of launch, and we couldn’t be more proud of how the team is executing. That said, we know our work is just beginning, and there are many more patients with TED that we can help. We believe there’s a significant long-term opportunity for Lynvoa, and we are 100% committed to continuing to deliver for patients. And with that I’ll turn it over to Seth.

Seth Harmon (Chief Financial Officer)

Thanks, Tony, and good morning, everyone. Our full third quarter results are in this morning’s press release and our Q3 10-Q, which was filed with the SEC this morning, so I’ll focus on the highlights. As mentioned, Lynvoa generated $24.7 million in net product revenue in its first quarter on the market. We ended the quarter with just over $955 million in cash, cash equivalents, and marketable securities on our balance sheet. We are in a strong financial position to fund and execute our current business plans through profitability.

With that, I’ll turn the call back to Steve for closing remarks.

Steve Mahoney (President and Chief Executive Officer)

Thank you, Seth. As you’ve seen, we’re off to a great start with the Lynvoa launch. What makes this moment even more exciting is the potential of Viridian Therapeutics’ pipeline as it comes into better focus. These programs can plug into our established infrastructure where we have a proven track record of execution, and we look forward to moving them ahead as fast as possible. Let’s quickly touch on the highlights of this pipeline. We delivered strong results in two pivotal Phase 3 clinical trials in TED and we are on track to submit the BLA in the first quarter of 2020. We believe Eli delivered in an autoinjector pen as infrequently as every eight weeks has the potential to transform TED treatment by bringing the robust clinical benefit of IGF-1R inhibition to patients for self-administration in their own homes.

VRDN-292 is our potential best-in-class, half-life–extended anti-TSHR program designed for infrequent subcutaneous delivery in an autoinjector, and we expect to start the Phase 1 study in Graves’ disease patients later this quarter. TSHR is a target that represents an exciting new approach to helping patients living with Graves’ disease and, building on Lynvoa and Eli, we believe Viridian Therapeutics is uniquely suited to advance this new mechanism and lead across the full spectrum of thyroid autoimmunity beyond TED and Graves’.

We’re excited about announcing updates on our FcRn portfolio later this quarter, including VRDN-008 first-in-human data. VRDN-008 is half-life extended and designed as a potential best-in-class FcRn inhibitor to treat patients across multiple autoimmune diseases, including several that are already commercially and clinically validated. We are also continuing to build what comes next, which ranges from internal discovery work to evaluating external opportunities.

These are really exciting times at Viridian Therapeutics. In closing, we are encouraged by our launch results at this early stage. We have more work to do as we execute from a position of strength. I want to thank our team, and the patients and physicians who are part of the early adoption of Lynvoa. We, as an organization, are extremely proud that Lynvoa is now reaching patients with TED.

OPERATOR

Please open the line for questions. We will now begin the question-and-answer session. Please limit yourself to one question. If you’d like to ask a question, please press star one to raise your hand. To withdraw your question, press star one. Again, we ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Laura Chico with Wedbush Securities.

Laura, your line is open. Please go ahead.

Laura Chico (Analyst at Wedbush Securities)

Good morning, and thank you for taking the question. Congratulations on the quarter. I guess I wanted to ask about the timeline between prescription issuance and revenue. It seemed like ahead of the launch you were anticipating a little bit lengthier timeline. Could you just talk about the cadence there and how it’s comparing post-launch? I guess what I’m trying to understand is, is this a bolus of demand, or should we anticipate kind of continued uptake?

Thank you very much.

Tony Casciano (Chief Commercial Officer)

Yeah, thank you for the question, Laura. So as discussed previously, we anticipate the timing between enrollment form to infusion to take typically 60 to 90 days, and that was based on what we understood to be the TEPEZZA experience early days of launch. We anticipated that being towards the later side. I can say that we’re pleased with what we’re seeing so far, but again, it’s early in this launch and we’ll need to see it sustained throughout subsequent quarters.

Particularly your question on bolus: we don’t believe that we’re seeing a bolus here. As a reminder, the TED marketplace doesn’t really lend itself to boluses of patients. It’s an urgent condition. Patients progress rapidly, and again, there was an existing therapy on the market prior to our launch, so we wouldn’t anticipate much of a bolus. But again, early quarters — we need to see this play out over subsequent quarters. Thanks for your question.

OPERATOR

Thanks, Tony. Your next question comes from the line of Faisal Kirscheed with Jefferies. Faisal, your line is open. Please go ahead.

Faisal Kirscheed (Analyst at Jefferies)

Hey, guys, thanks for taking the question. For those hundred patients that you had on Lynvoa at quarter end, can you at least at a high level try to characterize for us where we’re at within the infusion course for those patients? Just trying to understand, like as we’re going into the fourth quarter, how much kind of residuals we have left on those hundred patients and how to think about kind of de novo demand for the fourth quarter? Thank you.

Tony Casciano (Chief Commercial Officer)

Yeah, great, great question. So just based on when we were approved, the majority of those patients began therapy towards the latter part of the quarter.

Faisal Kirscheed (Analyst at Jefferies)

Got it. Thank you.

OPERATOR

Your next question comes from the line of Gavin Clark Gartner with Evercore ISI. Gavin, your line is open. Please go ahead.

Gavin Clark Gartner (Analyst at Evercore ISI)

Hey, guys, great to see the launch progress. I guess over 100 patients have been infused so far. Like, I’m calculating the revenue implies almost 300 doses that were given. I’m trying to square that with, like, a lot of the patients being treated later on in the quarter. Like, was there any amount of stocking or anything else to consider within the revenue number?

Tony Casciano (Chief Commercial Officer)

Yeah, excellent question. So, as previously discussed, we did not anticipate much stocking as a part of this launch, and that’s basically due to the fact that this is an on-demand market. Infusion centers will order the product once a patient is scheduled for infusing — there’s not much stocking to speak of. Part of why we felt it was important to include the over 100 patient starts as part of this release was to clearly illustrate that we believe that this revenue of $24.7 million in the quarter was driven by patient demand.

Gavin Clark Gartner (Analyst at Evercore ISI)

Okay, got it, thanks.

OPERATOR

Your next question comes from the line of Andy Chen with Wolfe Research. Andy, your line is open. Please go ahead.

Andy Chen (Analyst at Wolfe Research)

Hey, thank you for taking the question. So, Amgen yesterday, they reported a slightly lower quarter due to inventory. They didn’t mention any competition. Just based on your observations, are you mostly taking market share away from competition right now, or are you already seeing early signals of potential market expansion beyond the $2 billion run rate that they have? Thank you.

Tony Casciano (Chief Commercial Officer)

Yeah, great question, Andy. So, just to restate, our launch strategy is one of conversion, which I think we’ve mentioned prior. We’re focused on the 2,000 core prescribers that make up over 80% of IGF-1R prescribing. That’s where our focus is now. We have also said historically that we wouldn’t at all be surprised if we see some expansion in this market due to the profile of Lynvoa and due to the market dynamics. It’s, again, early days. We’re very encouraged by what we’re seeing so far.

We just need to see this play out over subsequent quarters.

OPERATOR

Your next question comes from the line of Derek Archilla with Wells Fargo. Derek, your line is open. Please go ahead.

Derek Archilla (Analyst at Wells Fargo)

Hey, good morning, and congrats on the launch progress. I guess, just based on our math, the greater than 100 patients on therapy implies Lynvoa captured about 10% of the new starts in the quarter. Is that a fair way to think about the initial share and, I guess, where do you see share going over the next 12 months? Thanks.

Tony Casciano (Chief Commercial Officer)

Yes, we’ll stop short on commenting on share and maybe just revert back to the strength of the quarter and our level of excitement of the strong start that we’re off to. You know, again, I think we should probably mention again, based on the strength of the execution of the team in the field. We were out early, as you know, prior to approval, scheduling appointments, engaging with customers, profiling accounts, and were able to hit the ground running within 24 hours of approval.

That led to rapid engagement, rapid education of the profile, and ultimately what you’re seeing in this release with over 100 patients started towards the end of the quarter. Again, we’re going to need to see how this plays out over time. We’re really encouraged by the trends so far.

OPERATOR

Your next question comes from the line of Alex Thompson with Stifel. Alex, your line is open. Please go ahead.

Alex Thompson (Analyst at Stifel)

Great, thanks for taking our question. Again, congrats on the quarter. Maybe to ask a more explicit question around sort of the exit velocity from the quarter: do you believe that what you’re seeing is sustainable from here, and then as the J-code becomes effective in January, how might that impact the trajectory? Thanks.

Tony Casciano (Chief Commercial Officer)

Yeah, thank you for the question. Look, we’re really excited by the results so far. We’re excited by the way we started the quarter. We’re excited by the way we ended the quarter. I think the question was already asked about a bolus. We don’t believe that’s the case in this market. It’s going to take some time for us to fully understand the strength of this launch over time. What we can comment on is what we’re seeing so far, which excites all of us.

We felt that there was a lot of potential for Lynvoa in this market over time. The results that you see today and our progress through this quarter confirms that excitement. But again, we’re going to need to see how this plays out over the subsequent quarters. Thanks for the question.

OPERATOR

Your next question comes from the line of Thomas Smith with Leerink Partners. Thomas, your line is open. Please go ahead.

Thomas Smith (Analyst at Leerink Partners)

Hey guys, good morning. Congrats on the really stellar launch quarter here and thanks for taking our questions. Could you just quantify some of the progress on payer coverage a bit more — like where are you today in covered lives with unrestricted access, and where do you expect this to go over the next six months, and how do you think this is going to impact the net revenue number going forward? Thanks so much.

Tony Casciano (Chief Commercial Officer)

Yeah, great question. We are really proud of the work that the market access team has done, enabled by, again, our being ready early, understanding this market, and being out ahead of approval through the pre-approval information exchange. I think we had commented that we had reached the majority of covered lives ahead of approval and then were able to reengage quickly post-approval with over 90% of covered lives represented in our post-approval meetings.

So I’m happy to say that through the end of the third quarter, as we exited September, we were already at 30% covered lives having a policy in place for Lynvoa, and the team continues to make progress throughout the fourth quarter. We can reiterate today that we believe that we would be at, you know, critical mass or broad coverage by six to nine months, and we are well on our way to achieving that.

OPERATOR

Your next question comes from the line of Gregory Renza with Truist. Gregory, your line is open. Please go ahead.

Gregory Renza (Analyst at Truist)

Hey, good morning guys. Congrats on the nice quarter and progress, and thanks for taking my question. Certainly, as you talk about the Lynvoa launch maybe surpassing your expectations and others’, what are you learning, and how does the performance and the execution perhaps shape the progress and the filing for local BART in the sub-Q? Is that helping to inform not just the timing but just the approach when it comes to bringing that asset forward before FDA?

Thanks so much.

Steve Mahoney (President and Chief Executive Officer)

Yeah, that’s a great question. So I’ll talk about the execution and what we’re seeing. We were in a very unique position as an organization with this opportunity where we had an extremely strong product profile. We had extremely talented employees here as we built out not just the commercial organization, but the organization in general, and a very focused and straightforward plan of conversion at launch. Anytime you have those three things — a compelling product profile, the right people in position executing well against a clear strategy — good things tend to happen, and that’s exactly what we saw in this quarter.

The really good news is that this is very repeatable with Ellie. We find ourselves again with a very strong product profile with Ellie as that’s shaping up — of course, we still need to get that approved. But once it does, the same team that’s in place now, the infrastructure we built to launch Lynvoa, is the same infrastructure we’ll use to launch Ellie. So we believe this is repeatable.

OPERATOR

Your next question comes from the line of Lisa Walter with RBC Capital Markets. Lisa, your line is open. Please go ahead.

Lisa Walter (Analyst at RBC Capital Markets)

Thanks for taking your question and congrats on the quarter. Can you give us an idea of how patient start forms are translating into patients on therapy? And can you share how many patients have received their second infusion? Any color here would be helpful. Thanks so much.

Tony Casciano (Chief Commercial Officer)

Yeah, fair question. As we look at the performance through the quarter, with over 100 patients starting on therapy, again, I think it was said prior, the majority of those patients were starting therapy towards the end of the quarter. So the majority of those patients are early in their treatment journey with us. I’m sorry, was there a second part of that question?

Lisa Walter (Analyst at RBC Capital Markets)

Yeah, I was curious about how patient start forms are translating to the number of patients who start on therapy.

Tony Casciano (Chief Commercial Officer)

Yeah, good question. We’re really happy with what we’re seeing. That’s another one of those things we’re going to have to see play out over time before we come to any concrete conclusions. But thank you.

OPERATOR

Your next question comes from the line of Joseph Thome with TD Cowen. Joseph, your line is open. Please go ahead.

Joseph Thome (Analyst at TD Cowen)

Hi there. Good morning, and thank you for taking my question, and congrats on the progress. Maybe of those 2,000 core prescribers, what proportion are those hundred patients that are on therapy? And beyond that, the prescription start forms that you are seeing coming from — is this kind of a collected group of core prescribers administering it in several patients, or are you seeing broad uptake? And maybe beyond that, what proportion of those 2,000 core prescribers have indicated an intent to use Lynvoa, maybe in the near term?

Thank you.

Tony Casciano (Chief Commercial Officer)

Yeah, great question. Just as a reminder, we are focused on the 2,000 core prescribers because they represent over 80% of all IGF-1R prescriptions. Our strategy is one of conversion, so you would anticipate that most of our use is coming from those 2,000 physicians that we’re targeting. Based on prior IGF-1R use, we’ll stop short of giving exact percentages, but suffice to say, we continue to be happy with the depth and breadth that we’re seeing.

This is not just early trial; we are seeing some early signals of adoption that’ll be key for us as we go forward to make sure that those trials are really good and positive first experiences, made possible by the support of Viridian Therapeutics and Viridian Cares, and that eventually translates into broader adoption. We’re happy with what we’re seeing so far on both breadth and depth, but again, we’ll need to see that play out over subsequent quarters.

OPERATOR

Your next question comes from the line of Douglas Tsao with H.C. Wainwright. Douglas, your line is open. Please go ahead.

Douglas Tsao (Analyst at H.C. Wainwright)

Hi, good morning. Thanks for taking the questions. I guess just maybe as a follow-up on that last one: in terms of prescribers, are you typically seeing prescribers initially trialing patients, or have you had instances with clinicians who were perhaps familiar with the drug from a clinical trial experience or just excited about the profile, who are really just wholesale switching over their head patient volume over to Lynvoa? Thank you.

Tony Casciano (Chief Commercial Officer)

Yeah, good question. Just to reiterate, we’re happy with what we’re seeing both from a breadth and depth perspective. We are seeing a bit of both. The percentages we won’t get into on the call, but just to reiterate, we are happy with what we’re seeing there too — and not to sound like a broken record, but we need to see this play out over time. It’s just one quarter.

Douglas Tsao (Analyst at H.C. Wainwright)

But just to corroborate, you are seeing a little bit of both in terms of some experimentation, and some docs who seem to be switching over pretty aggressively. Is that fair?

Tony Casciano (Chief Commercial Officer)

Yes, absolutely fair.

Douglas Tsao (Analyst at H.C. Wainwright)

Great. Thank you very much.

OPERATOR

Your next question comes from the line of Rami Katkuda with LifeSci Capital. Rami, your line is open. Please go ahead.

Rami Katkuda (Analyst at LifeSci Capital)

Hey guys, congrats on the strong launch. Thanks for taking my questions as well. I know it’s early, but can you touch on how the prescribing mix breaks down by physician specialty, and the split in Lynvoa use by active versus chronic TED patients?

Tony Casciano (Chief Commercial Officer)

Maybe I’ll take the second one first. As we said prior, based on our understanding of this market, roughly 80% of patients initiated on IGF-1R therapy are active patients, with the remainder 20% being chronic. Our strategy is one of conversion, so we are focused on the 2,000 core prescribers that generate 80% of current IGF-1R use. We would anticipate a similar mix over time to what has historically been the case. But again, as stated earlier, we would not be surprised at all to see some market expansion just based on the strength of the Lynvoa profile. We’re happy with what we’re seeing. The early returns are positive. It gives us a lot of confidence in the long-term potential of Lynvoa, but it’s early to make any definitive statements there.

OPERATOR

Your next question comes from the line of Michael Yee with UBS. Michael, your line is open. Please go ahead.

Michael Yee (Analyst at UBS)

Hey guys, great for the fourth quarter, appreciating the great launch you’re on. Do you expect an acceleration in the fourth quarter — like more than 100-something patients added in the fourth quarter — or should we think about some seasonality factors that may play into people’s cadence to be able to come in and therefore schedule things for the first quarter? Maybe just how we should think about that for modeling purposes in terms of patient adds in the fourth quarter.

And then, if I get an extra credit question for asking, on the pipeline — on 008 which has some data coming up — can you right-size our expectations for either IgG reductions or depth or speed of those IgG reductions and how we should compare that to others as you think about the profile? Thank you.

Steve Mahoney (President and Chief Executive Officer)

Yeah, thanks, Michael. Great question on Q4. We’ll stop short of giving any guidance for Q4, but suffice to say, with most of those over 100 patients starting towards the end of the quarter, we’ll walk into the fourth quarter with those patients on therapy. And yeah, look, we’re early in this launch, so we would anticipate some growth going into the next quarter. How much growth — we’re going to need to see more as we work through this launch to have any type of conviction on the rate of growth.

But again, really happy with what we’re seeing. We’re happy with the way that we exited the quarter and would anticipate a good fourth quarter as well. And on the 008 question, Mike: we are looking at what you would expect with respect to where the IgG reduction falls in terms of thresholds that have been pretty well established by some of the other programs. We’ll be looking for albumin sparing, we’ll be looking for the frequency of dosing, and so we know the profile that we would like to see, and now we just need to see that play out. As stated, we expect to be able to disclose that later this quarter.

OPERATOR

Your next question comes from the line of Richard Law with Goldman Sachs. Richard, your line is open. Please go ahead.

Richard Law (Analyst at Goldman Sachs)

Hey guys, congrats on a strong start. Can you discuss how that flexible payment program works for the infusion center when you’re waiting for that permanent J code to be active? What are the payment terms, and how are revenues recognized now compared to when you do receive payments sometimes later? Any color around this would be great, including how much Lynvoa so far is being utilized by this program. Thanks.

Seth Harmon (Chief Financial Officer)

Yeah, great question. So, revenue recognition: we recognize revenue when it’s received by the specialty distributors. Richard, we’re really excited by the team’s ability to execute in a pretty short window. Recall, we were approved at the end of June and had to get that application in on or around July 1st to hit that window. We did, we hit that window, and we’re really happy to receive confirmation from CMS that we have a permanent J code that will be effective January 1st of 2027.

I think it’s another instance of the team understanding this market, knowing how it works, and absolutely executing at a very high level to make it happen not just for us, but for our customers and patients as well. Pretty straightforward on — I won’t call it a payment plan, I will call it payment terms. We haven’t disclosed exactly what that looks like and probably won’t; we’ll stop short of that. But as we’re working through the J code period, which can create some cash flow issues for infusion centers, we did provide some relief in terms of extended payment terms, which you would see in the accounts receivable. How many patients from that hundred that you mentioned utilized this flexible payment term?

We appreciate the question; we’re not going to get into that level of detail. Thank you.

Richard Law (Analyst at Goldman Sachs)

Okay, thanks.

OPERATOR

Your next question comes from the line of Serge Belanger with Needham. Serge, your line is open. Please go ahead.

Serge Belanger (Analyst at Needham & Company)

Hi, good morning and congrats on a nice start. It sounds like you’ve made some strong progress so far on securing payer coverage. Just curious if you continue to expect coverage to be at parity to Tepezza, and could there be any differences for usage in the chronic segment or with retreatments? Thank you.

Tony Casciano (Chief Commercial Officer)

Yeah, great question. Thanks for mentioning the progress. We have 30% covered lives with a policy in place for Lynvoa, at parity in almost all of those cases. I would just reiterate that the team continues to make good progress, and we’re well on our way to our stated goal of having broad coverage by the six to nine month mark. I would also like to mention, just to be clear, you know, as these policies are coming online, there are other mechanisms and ways to get PAs approved through the medical exception process. And this is where the strength of our patient service team, our patient access liaisons, comes through in a big way.

So we don’t give up on a patient just because their insurance plan does not have coverage. There are mechanisms and ways to do that, and we’re seeing that happen on a regular basis. It’s also worth noting that a lot of these plans, while they’re reviewing the products in the process of establishing a policy, have interim plans in place. So there are ways. I didn’t want to create the perception that 70% of patients don’t have access. That’s just not true. However, our goal is, again, to hit the broad coverage, to make it as easy as possible for patients, physicians, and infusion centers by the end of the—by the six to nine month mark.

The other question was around, do we anticipate any differences in plans? Look, it’s certainly possible. We believe in the strength of the profile of Lynvoa. It’s resonating well with payers. That’s not our strategy. Our strategy is one of parity. We think that the strength of this drug is in the profile. And having parity access gives us the ability to compete and win with the physician as they’re making selections for their patients.

OPERATOR

Your last question comes from the line of Lachlan Hanbury Brown with William Blair. Lachlan, your line is open. Please go ahead.

Lachlan Hanbury Brown (Analyst at William Blair)

I’ll add my congrats. So I think prior to the launch you said one of the metrics you’d be giving was patient start forms. And obviously the greater than 100 on therapy is an impressive number, but wondering if you can give any kind of color on what the number of patient start forms is. That would include those that haven’t actually got treated yet.

Seth Harmon (Chief Financial Officer)

Yeah, thanks for the question. I believe we had intimated that we would be giving color on each of the launch priorities and that, you know, certainly a reasonable metric could be enrollment forms. I think what changed the calculus for us is the strength of the quarter from a revenue perspective. So 24.7 million in net revenues we think speaks for itself. We added patient starts just to make sure folks understood that this was not inventory driven, but demand driven.

So I’ll kind of stop there. On a go-forward basis, we will likely be sharing net revenues and then again considering across those launch priorities what we think is the most color on the strength of the launch at that point in time.

OPERATOR

There are no further questions at this time. We have reached the end of the Q and A session. I will now turn the call back to Steve Mahoney for closing remarks.

Steve Mahoney (President and Chief Executive Officer)

Great. Thank you. Thank you everyone for joining us this morning. We’re obviously off to a great start. It’s still early, but we’re really encouraged by what we’re seeing. So thank you very much. We look forward to talking to you soon.

OPERATOR

This concludes today’s call. Thank you for attending. You may now disconnect.

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