Viridian Therapeutics (VRDN) 2026年第3四半期決算説明会：Lumvoaの売上高が2,470万ドルに到達

要点

• Lumvoaは、市場投入後最初の四半期に2,470万ドルの製品売上高（純額）を計上しました。
• 2026年9月30日までに100人以上の患者がLumvoaの投与を開始し、少なくとも1回の点滴を完了しました。大部分の患者は同四半期の後半に治療を開始しました。
• Viridianの2026年第3四半期末時点における現金、現金同等物および有価証券は9億5,500万ドルを超えました。経営陣は、これが黒字化までの現在の事業計画を賄うのに十分であると述べています。
• 四半期末時点で、Lumvoaの保険適用ポリシーは米国の被保険者人口の30%をカバーしており、アクセス状況は概ねTEPEZZAと同等となっています。同社は、発売後6〜9ヶ月以内に広範なカバー率を達成するという目標に向けて順調に進んでいます。
• CMSは、2027年1月1日発効でLumvoaに恒久的なJコードを割り当てました。
• Viridianは、2027年第1四半期にElegrobartのBLAを提出し、2026年第4四半期後半にVRDN-292の第I相試験を開始、同四半期中にVRDN-008のヒト初回投与データを発表する計画です。

主要財務データ

事業および業績

Lumvoaの発売にあたっては、IGF-1R処方の80%以上を占める約2,000人のコア処方医に注力しました。Viridianは、一部の医師による初期試用や他の医師による積極的な切り替えを含め、導入の広がりと深さの両方が見られると述べています。

経営陣は、初期需要の理由としてLumvoaの臨床プロファイルを挙げています。具体的には、活動性および慢性の甲状腺眼症における眼球突出と複視の改善、早ければ3週間でみられる有意義な眼球突出の減少、そして5回の点滴で構成される12週間の治療コースです。

同社によると、第3四半期の売上高は在庫の積み増しではなく患者の需要を反映したものです。点滴センターは通常、患者の予約が入った後にLumvoaを発注するため、在庫を抱える必要性が抑えられます。売上高は専門卸売業者が製品を受領した時点で計上されます。

Viridianは、米国の被保険者人口の90%以上をカバーする承認後の説明会を完了しました。正式な支払者ポリシーがまだ適用されていない場合、同社はViridianCaresを通じた医療上の特例や一時的なアクセス制度を活用しています。また、恒久的なJコードが有効になる前に点滴センターの資金繰りを支援するため、支払い猶予期間の延長条件を提供しています。

経営陣の見通し

経営陣は、第3四半期後半に治療を開始した患者に支えられ、2026年第4四半期にLumvoaの一定の成長を見込んでいます。ただし、発売開始からまだ初期段階にあるため、売上高や新規投与開始患者数の数値予測は提供しませんでした。

Viridianは引き続き、発売後6〜9ヶ月以内にLumvoaの広範な保険カバー率を達成することを目標としています。恒久的なJコードは2027年1月1日に発効します。

パイプラインについては、同社は2027年第1四半期にElegrobart（通称Ellie）のBLAを提出する予定です。この皮下注射抗IGF-1R候補薬は、最長8週間に1回という低い頻度での自宅での自己投与が可能なように設計されています。

Viridianはまた、2026年第4四半期後半にバセドウ病患者を対象としたVRDN-292の第I相試験を開始する見込みです。同四半期中にはVRDN-008のヒト初回投与データの発表が見込まれており、経営陣はIgG低減、アルブミン保持、および投与頻度に注目しています。

リスクと注目点

• 経営陣は、Lumvoaが発売開始後の四半期を1期完了したに過ぎず、需要の傾向は今後の期間においても持続する必要があると繰り返し強調しました。
• 支払者のポリシー導入時期はそれぞれ異なりますが、Viridianは医療上の特例や一時的なポリシーを通じて引き続きアクセスを取得可能であると述べています。
• 登録フォーム提出から点滴完了までに想定される60〜90日間の期間は、発売後の重要な変動要素として残っています。
• 恒久的なJコードが発効する前に提供される支払い条件の延長は、売掛金を増加させる可能性があります。
• 同社の初期の商業戦略は、既存のIGF-1R使用からの切り替えを中心に展開されています。経営陣は市場拡大の可能性はあるとしつつも、結論を出すには時期尚早であると考えています。

アナリスト質疑応答の要点

アナリストらは、第3四半期の需要が発売初期の一時的な急増（ボウラス）に過ぎないのではないかという点に大きな関心を寄せました。経営陣は、TED（甲状腺眼症）が緊急性の高い病態であり既存の治療法がすでに利用可能であることを挙げ、一時的な急増ではないと考えていると述べました。100人を超える患者の大部分は第3四半期の後半に治療を開始し、治療を継続した状態で第4四半期に入りました。

支払者のアクセスについて、Viridianは四半期末時点で被保険者人口の30%をカバーするポリシーを報告し、その大部分はTEPEZZAと同等でした。経営陣は、医療上の特例や支払者の一時的な仕組みが引き続き利用可能であるため、残りの70%についてアクセスがないと解釈すべきではないと強調しました。

同社は、市場シェア、登録フォーム数、転換率、または支払い条件の延長を利用している患者数についての具体的な数値の開示を控えました。それにもかかわらず、初期の処方は広範に行われており、一部の医師の間で継続的な処方が現れ始めていると説明しました。

第4四半期について、経営陣は成長を見込んでいるものの、その規模については言及しませんでした。同社は、第3四半期の開始率と終了率（エグジットレート）の両方に手ごたえを感じているとする一方、持続可能な成長軌道を確立するにはさらに数四半期が必要であると注意を促しました。

決算説明会文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Good morning, ladies and gentlemen, and welcome to the Viridian Therapeutics Conference Call. [Operator Instructions] 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 Rossino

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 Investor 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 our -- the forward-looking statements section 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. Shan Wu, our Chief Business Officer, will join us for Q&A. With that, I'll turn the call over to Steve.

Stephen Mahoney

Thanks, Greg, and good morning, everyone. Thank you for joining us to discuss the results from our first quarter of Lumvoa 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. Lumvoa generated $24.7 million in net product revenue, and we have more than 100 patients on therapy as of September 30. 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 Lumvoa's compelling product profile and the readiness and execution of our entire organization since day 1 of launch.

Before we provide more color on the Lumvoa 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 Elegrobart in the first quarter of 2027. Ellie is our next-generation subcutaneous anti-IGF-1R. Based on our Phase III 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 8 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 I clinical trial of 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 Lumvoa launch.

Anthony Casciano

Thanks, Steve, and good morning, everyone. It's been incredibly rewarding for our team to bring Lumvoa to patients with TED, and I'm proud of the start with TED. I'll start with a quick reminder of the market and Lumvoa'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 and affects 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 is an opportunity for Lumvoa to be chosen. That's where Lumvoa comes in. Lumvoa has a compelling product profile that we believe is aligned to unmet needs in TED. In our clinical trials, Lumvoa 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 3 weeks. We believe this combination of rapid, robust and durable benefit is a compelling profile for TED patients. Furthermore, Lumvoa delivers those benefits with a short 12-week course of therapy and just 5 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 Lumvoa launch exceeded expectations. We believe this strong start is driven by Lumvoa's compelling product profile, years of preparation and strong execution by the Viridian team. When we announced Lumvoa 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 3 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 are fully trained and in the field, talking to physicians about Lumvoa 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 Lumvoa on our estimated time line of 6 to 9 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 Lumvoa, 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 Lumvoa profile is translating into strong early demand for Lumvoa. More than 100 patients were being treated with Lumvoa at the end of the quarter. To be clear, these aren't enrollment forms. These are more than 100 patients who started treatment with Lumvoa and have 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 the 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 Lumvoa 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 ViridianCares. That's where we're focused in the fourth quarter and beyond. With prescribers, we're focused on continuing to educate on Lumvoa'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 Lumvoa and facilitate patient access. As we have stated, policy adoption takes time after product approval and payers often have different time lines for decision-making. The team has made excellent progress on this front, and we'll continue to expand from here. With respect to patients, ViridianCares, which is our patient support service fee, continues to be critical to launch. ViridianCares 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 with 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 is a significant long-term opportunity for Lumvoa, and we are 100% committed to continuing to deliver for patients. And with that, I'll turn it over to Seth.

Seth Harmon

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, Lumvoa 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.

Stephen Mahoney

Thank you, Seth. As you've seen, we're off to a great start with the Lumvoa launch. What makes this moment even more exciting is the potential of Viridian's 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. Ellie delivered strong results in 2 pivotal Phase III clinical trials in TED, and we are on track to submit the BLA in the first quarter of 2027. We believe Ellie delivered an auto-injector pen as infrequently as every 8 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.

VRGN-292 is our potential best-in-class half-life extended anti-TSHR program designed for infrequent subcutaneous delivery in an auto-injector, and we expect to start the Phase I 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 TED. Building on Lumvoa and Ellie, we believe Viridian 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. 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, the patients and physicians who are part of the early adoption of Lumvoa. We, as an organization, are extremely proud that Lumvoa is now reaching patients with TED. Operator, please open the line for questions.

Operator

[Operator Instructions] Your first question comes from the line of Laura Chico with Wedbush Securities.

質疑応答

Laura Chico

Congratulations on the quarter. I guess I wanted to ask about the time line between prescription issuance and revenue. It seemed like ahead of the launch, you were anticipating a little bit lengthier time line. 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?

Anthony Casciano

Yes. 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 conduce itself to a bolus of patients. It's an urgent condition. Patients progress rapidly. And again, there's an existing therapy on market prior to our launch. So I 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

Your next question comes from the line of Faisal Kurshid with Jefferies.

Faisal Khurshid

For those 100 patients that you had on Lumvoa 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 100 patients and how to think about kind of de novo demand for the fourth quarter?

Anthony Casciano

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

Operator

Your next question comes from the line of Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner

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?

Anthony Casciano

Yes, 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 infusion, 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.

Operator

Your next question comes from the line of Andy Chen with Wolfe Research.

Andy Chen

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?

Anthony Casciano

Yes. 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 Lumvoa 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, Andy.

Operator

Your next question comes from the line of Derek Archila with Wells Fargo.

Derek Archila

Congrats on the launch progress. I guess just based on our math, the greater than 100 patients on therapy implies Lumvoa 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?

Anthony Casciano

Yes. So I'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. 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 we're 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.

Alexander Thompson

On the quarter. Maybe to ask a more explicit question around sort of the exit velocity from the quarter. I guess, 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?

Anthony Casciano

Yes. 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 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 Lumvoa 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 Smith

Congrats on the really stellar launch quarter here. Could you just quantify some of the progress on payer coverage a bit more? Like where are you today on covered lives with unrestricted access? And where do you expect this to go over the next 6 months? And how do you think this is going to impact the net revenue number going forward?

Anthony Casciano

Yes. Great question. We are really proud of the work that the market access team has done enabled by, again, here, 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 we're 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 Lumvoa, and the team continues to make progress throughout the fourth quarter. We can reiterate today that we believe that we would be at critical mass or broad coverage by 6 to 9 months, and we are well on our way to achieving that mark.

Operator

Your next question comes from the line of Gregory Renza with Truist.

Gregory Renza

On the nice quarter and progress. Certainly, as you talk about the Lumvoa launch, maybe surpassing yours and expectations of others, what are you learning? And how does the performance and the execution perhaps shape the progress and the filing for Elegrobart 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?

Anthony Casciano

Yes, it's a great question. Let's talk about the execution and what we're seeing. So 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, a very focused and straightforward plan of conversion at launch. So any time you have those 3 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 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, same team that's in place now, the infrastructure we built to launch Lumvoa is the same infrastructure we 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 Walter

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.

Anthony Casciano

Yes, fair question. As we look at the performance of the quarter with over 100 patients starting on therapy, again, I think it was said prior. majority of those patients were starting therapy towards the end of the quarter. So 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

Yes. I was curious about how patient start forms are translating to the number of patients who started therapy.

Anthony Casciano

Yes. Yes, good question. So yes, so here, too, 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 Thome

Congrats on the progress. Maybe of those 2,000 core prescribers, what proportion are those 100 patients that are on therapy and maybe 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 Lumvoa maybe in the near term?

Anthony Casciano

Yes, great question. So 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 will 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 and ViridianCares that eventually translates into broader adoption. But 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 Tsao

I guess just maybe as a follow-up on that last one in terms of prescribers. I'm just curious, are you typically seeing prescribers sort of 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 or really just wholesale switching over their TED patient volume over to Lumvoa?

Anthony Casciano

Yes. Good question. Just to reiterate, we're happy with what we're seeing both from a breadth and depth. perspective. So 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 just -- we need to see this play out over time. It's just one quarter.

Douglas Tsao

And but I guess just to clarify, you are seeing a little bit of both in terms of some experimentation, but some hitos you seem to be switching over pretty aggressively. Is that fair?

Anthony Casciano

Yes, absolutely fair.

Operator

Your next question comes from the line of Rami Katkhuda with LifeSci Capital.

Rami Katkhuda

On the strong launch. I know it's early, but can you touch on how the prescribing mix breaks down by physician specialty and the split in Lumvoa used by active versus chronic TED patients?

Anthony Casciano

So maybe I'll take the second one first. So as we said prior, based on our understanding of this market, roughly 80% of patients initiated an 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 Lumvoa profile. Happy with what we're seeing. The early returns are positive. It gives us a lot of confidence in the long-term potential of Lumvoa but early to make any definitive statements there.

Operator

Your next question comes from the line of Michael Yee with UBS.

Michael Yee

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 also some seasonality factors that may play into sort of people's cadence to be able to come in and therefore, schedule things for the first quarter? Maybe just think about 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 pipeline. on 008, which has some data coming up, can you just right size your 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?

Anthony Casciano

Yes. Thanks, Michael. Great question. On the Q4, so we're stop short of giving any guidance for Q4. But suffice to say, with most of those 100 patients, over 100 patients starting towards the end of the quarter, we'll walk into the fourth quarter with those patients on therapy. And yes, 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 be -- 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.

Stephen Mahoney

And on the 008 question, Mike, yes, I think we are looking for what you would expect with respect to where does the IgG reduction fall in, in terms of where the thresholds are that have been pretty well established. by some of the other programs in FcRn. 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. And we expect -- 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.

Jin Law

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? And what are the payment terms and also like how are revenues recognized now compared to when you do receive payments sometimes later? Like any color around this would be great, including like how much Lumvoa you so far are being utilized by this program?

Anthony Casciano

Yes. Great question. So revenue recognition, so we recognize revenue when it's received by the specialty distributors. As you mentioned, Jacob, 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 and on or around July 1 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 1, 2027. So I think 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 payment plan, I will call it payment terms. So we haven't disclosed exactly what that looks like and probably won't 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.

Jin Law

How many patients from that 100 that you mentioned utilized as payment terms?

Anthony Casciano

Yes. I appreciate the question. We're not going to get in that level of detail.

Operator

Your next question comes from the line of Serge Belanger with Needham.

Serge Belanger

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?

Anthony Casciano

Yes. Great question. So yes, thanks for mentioning the progress. So 30% covered lives with a policy in place for Lumvoa 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 6- to 9-month mark. I would also like to mention, just to be clear, 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 product 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 get the broad coverage to make it as easy as possible for patients, physicians and infusion centers by the end of -- by the 6- to 9-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 Lumvoa. 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 Hanbury-Brown

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, greater 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.

Anthony Casciano

Yes. Thanks for the question. I believe we had intimated that we would be giving color on each of the launch priorities. And that certainly 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&A session. I will now turn the call back to Steve Mahoney for closing remarks.

Stephen Mahoney

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.