バイオジェン (BIIB) 2026年第3四半期決算説明会：売上高11%増、EPSガイダンスを引き上げ

主要ポイント

• バイオジェンが発表した2026年第3四半期の総売上高は前年同期比11%増の28億ドルとなり、アペリス買収が成長加速に寄与しました。
• コア医薬品売上高は前年同期比18%増、前四半期比9%増の20億ドルとなりました。成長ポートフォリオは約13億ドルを創出し、コア医薬品売上高の63%を占めました。
• スピンラザの売上高は前年同期比23%増の4億6,100万ドルとなり、高用量投与法への急速な切り替えと一時的な移行用量の投与が追い風となりました。
• バイオジェン傘下での初の通期四半期において、サイフォブレとエンパベリは合計で2億4,300万ドルを寄与しました。経営陣は、アペリスの買収取引が営業ベースでほぼ中立になったと述べています。
• バイオジェンは2026年通期のNon-GAAP希薄化後EPS予想の下限を引き上げ、新たな予想レンジを12.20ドルから13.00ドルとしました。
• 同社は6億ドルのフリーキャッシュフローを創出し、手元資金13億ドル、純負債64億ドルで当四半期を終えました。

主要財務データ

事業および営業業績

スピンラザの売上高は前年同期比23%増、前四半期比15%増の4億6,100万ドルとなりました。経営陣は、増収の主因を高用量投与法への予想以上のペースでの移行によるものとしています。また、当四半期は一時的な移行用量の投与もプラスに寄与しましたが、移行作業が正常化するにつれて減少する見込みです。

スカイクラリスの売上高は前年同期比34%増、前四半期比6%増の1億7,800万ドルに達しました。業績には経営陣が第4四半期に解消を見込む約1,200万ドルの在庫積み増しが含まれています。今後の需要拡大は、ブラジルでの最近の承認を含め、継続的な海外展開が後押しすると期待されています。

ヴメリティの売上高は前年同期比11%減、前四半期比2%減の1億9,200万ドルとなりました。バイオジェンはメディケア・パートDにおけるフォーミュラリー管理の厳格化を理由に挙げています。経営陣は、現在の動向が同製品の今後の成長に向けた新たなベースラインになると考えています。

タイサブリの売上高は前年同期比1%増の4億3,700万ドルとなりました。米国の業績は在庫の動きがプラスに働き、欧州事業は皮下注射製剤に支えられて堅調に推移しました。

サイフォブレの売上高は前年同期比27%増の1億9,100万ドルでした。商用投与回数は前年同期比18%増、前四半期比7%増となり、発売以来最高の四半期実績を記録しました。売上高には第4四半期に解消が見込まれる約1,100万ドルの在庫積み増しが含まれています。

エンパベリの売上高は、腎臓病適応症であるC3Gおよび原発性IC-MPGNの需要に牽引され、前四半期比11%増の5,200万ドルとなりました。PNHの需要は安定しており、バイオジェンは競争の激しい同市場向けに専任営業チームの採用を進めています。

バイオジェンは、アペリスの統合が想定以上のペースで進展していると発表しました。同社は引き続き2027年末までに少なくとも2億5,000万ドルの年間ベース（ランレート）のシナジー創出を目標としており、2027年には本取引がNon-GAAP希薄化後EPSにプラス寄与すると見込んでいます。

業績予想・見通し

バイオジェンは2026年通期のNon-GAAP希薄化後EPS予想の下限を12.20ドルに引き上げ、予想レンジを12.20ドル〜13.00ドルとしました。経営陣は主にアペリスの好調な業績と費用シナジー獲得の加速を修正の理由としています。

同社は、2026年通期での増収回帰に向けて順調に進展していると述べました。また、後期パイプライン計画への投資や発売前準備活動を含め、第4四半期には季節要因によりコア営業費用が増加すると見込んでいます。第4四半期には約5,000万ドルの取得IPR&D費用が見込まれます。

第4四半期について、経営陣は以下の見通しを示しています。

• スピンラザの世界売上高は、高用量への移行パターンの正常化に伴い、2025年第4四半期から1桁台半ばの増収率となる見通しです。
• ヴメリティの売上高は前四半期比でほぼ横ばい、または2025年第4四半期比で約1桁台半ばの増収となる見通しです。
• サイフォブレの売上高は、在庫の正常化および一時的な価格面での恩恵の反動減があるものの、アペリスが2025年第4四半期に計上した1億5,500万ドルから約1桁台半ばの増収となる見通しです。

バイオジェンは、アペリス買収に関連する残りのタームローン14億ドルを2027年末までに返済する予定です。第3四半期中に4億ドルを返済し、当四半期末までに累計6億ドルを返済しました。

リスクと注目点

第4四半期の比較は、スピンラザの一時的な移行用量の正常化、ならびにスカイクラリスとサイフォブレの在庫削減の影響を受けます。また、受託製造バッチのコミットメント時期の関係から、バイオジェンは受託製造売上高の減少も見込んでいます。

ヴメリティは引き続き制限的なパートDフォーミュラリー管理に直面しています。エンパベリは競争の激しいPNH市場で展開しており、今後のAMRでの導入は移植センターのプロトコルや医師への啓発活動に依存する可能性があります。

治験の進捗管理（クリニカル・エグゼキューション）は引き続き中心的な不確実要素です。経営陣は全身性エリテマトーデスの多様性を強調し、データを確認する前に第III相試験の成功確率について推測することを控えました。

アナリスト質疑応答の要点

経営陣は、全身性エリテマトーデスを対象とした第III相試験の結果公表が12月前半に予定通り行われると述べました。治験デザインの対策には、ステロイドの減量や背景となる標準治療薬の管理厳格化が含まれます。バイオジェンはSRI-4を適切な主要評価項目とみなしていますが、データの統合やサブグループ解析はデータおよび当局との議論次第であるとしています。

抗体関連型拒絶反応におけるフェルザルタマブについて、経営陣は対応可能市場（TAM）における対象患者数を約11,000人と試算しています。バイオジェンは、良好な治験結果および承認を前提とした将来的なプロトコル導入への準備と教育活動を支援するため、すでに100箇所の移植センターにメディカルチームを配置しています。

サイフォブレについて、経営陣は商用投与量の増加要因として無償提供薬の使用減少と、地図状萎縮（GA）治療に対する医師の処方マインドの向上を挙げています。バイオジェンは治療への期待に焦点を当てた患者および医療提供者向けの教育活動を策定しており、来年には消費者向け直接宣伝（DTC）活動を再開する計画です。

バイオジェンによると、第3四半期末時点で既存の12mgスピンラザ患者の70%が高用量投与法の開始申請書を提出しており、50%がすでに投与を受けました。経営陣は、移行の加速により来年一時的な移行恩恵を受けられる対象患者数が減少すると注意を促しました。

資本配分について、経営陣は社内投資において収益性の規律を維持しつつ、商業化の実行とR&Dを優先すると述べました。外部のイノベーションに関しては、創薬研究から第Ib相までの資産を好ましい対象範囲と位置付ける一方、既存フランチャイズを強化する機動的な取引にも引き続き前向きであると説明しました。

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. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2026 Earnings Call and Business Update. [Operator Instructions] Today's conference is being recorded. Thank you.

I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Tim Power

Thanks, Cynthia, and good morning, everybody. Welcome to Biogen's Third Quarter 2026 Earnings Call. During this call, we will make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide you a comprehensive list of risk factors in our SEC filings, which I encourage you to review.

Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed on this call can be found in the Investors section of biogen.com. We've also posted the slide to our website that we'll use during the call.

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; Robin Kramer, our Chief Financial Officer; Alisha Alaimo, President, North America, is also available for the Q&A section of the call.

We'll make some opening comments, and we'll move to the Q&A session and to allow us to get to as many questions as possible, we'll ask you to kindly limit yourself to just one question.

And I'll now hand the call over to Chris.

Christopher Viehbacher

All right. Thank you, Tim. Good morning, everybody. Very strong quarter this morning. It's actually one of those quarters where the numbers almost just speak for themselves. Total revenue grew 11% year-over-year. Of course, that's not all organic. That was significantly benefited from the acquisition of Apellis. But I'd also say that I think the acquisition and the integration of Apellis has gone even better than expected.

The integration team has, I think, been able to identify and eliminate cost synergies faster than we thought. Alisha is here, and I have to give Alisha a lot of credit for her leadership in and really ensuring that the Apellis team has felt welcome within Biogen. And I think really the most credit goes to the people from Apellis, who have joined Biogen placed their faith in Biogen and have been able to look past the inevitable distraction that comes with an integration and really focus on our customers, the health care professionals and patients that we serve.

So as I look at it, obviously, Apellis has certainly helped us. Our industry has embraced bolt-on acquisitions over the years. But one of the things I've learned is you're going to do a bolt-on, you have to bolt on to something solid. And 1 of the things that we have been working on at Biogen over the last several years is really to improve our cost base, but also to really launch our growth products and get those performing at a top level.

And that's important because when you do an acquisition, there is an inevitable amount of distraction. And if you've got a team that's already performing well, then it can not only find the time to embrace a new team joining the company. But the new team joining also finds a culture of energy of positive spirit that becomes infectious in some ways.

And so I think we've really realized the synergy between the folks from Apellis, who joined the Biogen teams. They've come together. And when I look at SYFOVRE and EMPAVELI, you can see 30-some percent year-over-year growth of $243 million. that's already on a run rate of $1 billion, and we're on track to realize $250 million of run rate synergies by the end of 2027.

And in fact, you'll see from the guidance that we put out and Robin will detail this more, but we've reduced our estimate of what the dilution will be in this first year of acquisition. In fact, most of the dilution will be really from the financing. On an operating level, the dilution is already pretty much negligible.

If I look at Biogen's own growth portfolio, $1.26 billion, that's 50% year-over-year growth. That's now almost getting to 2/3 of our core pharmaceutical revenue in Q3. And so this is where the story has been that we've obviously had a legacy portfolio that continues to be resilient. But the future is really with the growth products.

And so if I go to the next slide, we've really got 3 key priorities here. One is to continue to grow that commercial portfolio. And as I say, the 50% growth is extremely strong. and we expect to return to top line growth in 2026. I will say that the resilience of the legacy MS portfolio, I've said this in the past, it's not by accident.

Biogen has a unique patient services team. I think we have built strong relationships with key physicians and have earned the trust of a lot of patients. And I think that is a capability that's going to be extremely important as we turn to the next priority, which is multiyear registrational data flow.

The first point I'd make on that is, given the Apellis acquisition, we now think that the company can grow even without the pipeline. So as the pipeline starts to read out, and I think the first readout will be now just weeks away, we think we can be launching products, assuming that clinical trial results are positive, we'll be able to launch products on top of a growing base.

The other I would say is there's going to be a number of areas where we're still in breakthrough AMR is a market, for instance, that doesn't exist, MDI is a market that doesn't exist. In fact, a lot of education is needed, but we're already seeing high levels of awareness on those. We do know how to create and build markets. We're not a company that is just used to going in and finding an existing market, just taking market share. That will also be important in lupus.

And Alisha can provide a lot more insight here. But when you look at the lupus market, is it a fraction of what the MS market is. And there's no real good reason for that. We have found some insights into that. One is that patients will be expected to be on treatment for many, many years. And with only 2 approved biologics physicians tend to conserve those biologics until a patient progresses. And we're certainly seeing an awful lot of feedback from the market that if another biologic does get approved, that there would be an enhanced willingness to actually use biologics at an earlier stage.

And I go back to how Biogen has built its MS business and have been able to retain it in the face of some pretty fierce competition. And I think a lot of those capabilities and skills will really enable us to think about how we can actually develop the lupus market beyond way beyond where it is today. And just really in the next 18 months, we've got Phase III readouts expected not only in SLE, but we've got cutaneous lupus.

We've got AMR and our partners at Stoke, we expect to be reporting on Zorevunersen in [indiscernible] syndrome. And then the third priority, the third party, I think, is 1 of the most important and often most neglected areas of our industry. And this is some -- this is an area where we have top leadership at Biogen are spending a lot of our time. because it's in research and early development that you are building the future of your company. And we were not necessarily very good with that.

We have gone 3 years without a single IND. Under the leadership of Jane Grogan and in partnership with Priya Singhal, they have done a radical overhaul of the whole research and early development area. We now have 6 new programs expected with the 3 NMEs. We've already had 5 INDs this year as Priya will tell you, Biogen in its 48 years history, has never had 5 INDs in a single year.

And our ambition is over the next few years to have at least 20 programs in early-stage development. And this is a big shift in how we operate because Biogen historically has looked at things on an asset-by-asset basis. And we are now really thinking about portfolios of opportunities. How do we balance the risk, how do we balance that with franchise development and breakthrough medicines along with best-in-class and not always just first-in-class medicines. So this is an area where we're already planning for the future.

In this business, the day you launch a new product is the day you should be thinking about what product is going to succeed. And so those are the 3 areas. I think it's exciting. The future of Biogen is the for us.

And with that, I'll turn it over to Priya, who can give us a little bit more insight to the excitement of waiting us.

Priya Singhal

Thank you, Chris, and good morning, everyone. Over the past few years, you have heard us talk about the pipeline transformation, as Chris just mentioned. I'd like to take a few minutes to remind you of where we are today. Our new Biogen strategy remains centered around delivering a path to sustainable growth over the long term, and we are pleased by the progress we've made in delivering on that goal. This is an exciting time for Biogen.

And today, as a result of this strategy, we have 1 of the strongest and most diversified late-stage pipelines in Biogen's history with the potential to address significant unmet need across neurology, immunology and kidney disease. We showed you this slide last quarter, and as we previously communicated, due to strong execution by our teams and positive enrollment momentum, we were able to pull forward the TOPAZ-2 SLE readout folitufolumab and the TRANSCEND readout for felzartamab in AMR.

So reflected on the slide, I'm pleased that our upcoming registrational readout cycle remains on track. Starting with our planned disclosure of the Phase III SLE studies for litufulumab in the first half of December. As we turn beyond that, we expect CLE data from [indiscernible] as well as AMI data from salzatumab, followed by a readout from ZorumNersen in Ravi syndrome expected in the third quarter of next year.

Beyond that, we expect to continue our multiyear cycle of important registrational data flow through the end of the decade. Each of these upcoming catalysts has potential to meaningfully shape Biogen's next phase of growth, while most importantly, creating the possibility of new treatment options for patients.

As Chris also mentioned, we have remained focused on building and rebuilding our early-stage pipeline. We will continue to focus on our portfolio construction and evaluate internal and external innovation on a program-by-program basis with a scientific and disciplined approach. Looking to the future, I'm excited about how our transform pipeline has the potential to benefit patients across disease areas, and I look forward to providing updates as we move forward.

With that, I would now like to turn the call over to Robin for the financial update. Thank you.

Robin Kramer

Thank you, Priya. I'm pleased to provide an update on another strong quarterly financial performance. Our results reflect the continued momentum in our commercial portfolio that we've seen throughout this year and Q3 marks the first full quarter with SYFOVRE, EMPAVELI in our growth portfolio.

Total third quarter core pharmaceutical revenue was $2 billion, up 18% year-over-year and 9% quarter-over-quarter. This was driven by the continued strong performance of our growth portfolio, which generated approximately $1.3 billion of revenue in the quarter, up 49% year-over-year and 19% quarter-over-quarter. In addition, SYFOVRE and EMPAVELI together contributed $243 million in Q3 2026. The portfolio now represents approximately 63% and of our total core pharmaceutical revenue. This quarter's results demonstrate continued strong commercial execution and emphasizes the significant progress we've made in our portfolio transition.

Let me now take you through key highlights from our core pharmaceutical product performance in the third quarter. First, the growth portfolio. SPINRAZA revenue was $461 million, up 23% year-over-year and 15% quarter-over-quarter. This performance was driven primarily by rapid patient conversion to the high dose regimen with the quarter reflecting a meaningful revenue tailwind associated with the onetime transition doses for patients converting from low dose SPINRAZA.

As the conversion cohort matures and dosing patterns normalize, especially in the U.S. We expect global Q4 revenue to be up approximately a mid-single-digit percentage versus the fourth quarter of 2025. We are pleased with the rapid pace of conversion to high dose, which has exceeded our expectations. We believe the enthusiasm from patient and prescriber communities is encouraging for the opportunity for [indiscernible] revenue was $192 million, down 11% year-over-year and 2% quarter-over-quarter.

Revenue in the quarter was impacted by a shift in the Part D landscape, where payers have adopted a tighter approach to formulary management, a broader macro trend that we are seeing across the industry. We expect to continue to see this formulary dynamic affect Part D drugs like VUMERITY this year. As a result, we expect fourth quarter revenue from emeriti to be roughly flat sequentially or up approximately a mid-single-digit percentage versus the fourth quarter of 2025.

Beyond that, we believe these dynamics establish a new base from which VUMERITY can grow. Lakevi end market revenue was $202 million, up 67% year-over-year, and 10% quarter-over-quarter as we've seen a continuation of market growth in key geographies. We are in the early phases of the iClick launch and have started to see some uptake in the U.S. Patients can currently access reimbursement for iClick through a medical exception process.

We expect uptake to be gated by broader reimbursement with coverage plans now being finalized we're encouraged that at least 50% of covered lives are expected to have coverage in both the initiation and maintenance administration starting in 2027 and which should support iClick adoption as we move into the next year.

Skyclaris saw patient demand growth both in the U.S. and ex U.S., with revenue of $178 million representing 34% growth year-over-year and 6% quarter-over-quarter. Third quarter performance also reflects favorable inventory dynamics, including an inventory build of approximately $12 million that we expect to be drawn down in Q4.

For our legacy MS portfolio, TYSABRI revenue of $437 million was up 1% year-over-year U.S. revenue benefited from year-over-year inventory dynamics, while the European business continues to show stability driven by the subcutaneous formulation. We have been pleased that TYSABRI has been able to demonstrate meaningful resilience in light of a competitive MS market.

Let me now turn to SYFOVRE and EMPAVELI. Q3 represents the first full quarter of operations following the close of the Apellis acquisition in May and the integration has continued to progress well with both SYFOVRE and EMPAVELI having another strong performance this quarter. SYFOVRE revenue was $191 million, up 27% year-over-year driven by continued commercial injection volume growth, which was up 18% year-over-year and 7% quarter-over-quarter.

The third quarter has the strongest commercial injection quarter since launch, and SYFOVRE continues to demonstrate market leadership and geographic atrophy. I would note that third quarter results include approximately an $11 million inventory build, which we expect to be drawn down in Q4.

Looking forward to Q4, we also anticipate our price will normalize back to historic levels following a onetime price benefit related to the launch of the co-pack. Despite this, we expect fourth quarter revenue to be up approximately a mid-single-digit percentage versus the $155 million reported by Apellis in the fourth quarter of 2025. At the EMPAVELI revenue was $52 million, which was up 11% quarter-over-quarter, driven by strong demand for the nephrology indications, C3G and primary IC-MPGN.

Sequential demand for PNH remains stable and with this market being highly competitive, we are hiring a dedicated sales force to drive PNH penetration. In light of this commercial performance, and the pace of integration synergy capture, we believe this transaction is now roughly neutral on an operating basis, and we expect the transaction to be less dilutive in 2026.

We continue to expect the transaction to be accretive to non-GAAP diluted EPS in 2027, generating at least $250 million of run rate synergies by the end of 2027. Now turning to financial highlights for the quarter. Total revenue was $2.8 billion, up 11% year-over-year. This marks an acceleration in our top line growth trajectory, supported by the impact of the Apellis acquisition on our overall revenue profile.

Non-GAAP core OpEx or combined R&D and SG&A expense increased 27% year-over-year. This increase primarily reflects the expected impact of Appellate operating expenses as well as continued investment in our Phase III programs, [indiscernible], felzartamab in AMR, [indiscernible] syndrome and salinersen and SMA as well as support for the U.S. and international product launches and prelaunch activities for our late-stage pipeline assets.

As we previously announced, we recorded $284 million of acquired IPR&D and milestone charges in Q3 2026, largely associated with our Rather acquisition. This reflects an approximately $1.70 impact to non-GAAP diluted EPS and approximately $1.65 impact to GAAP diluted EPS.

GAAP EPS was a loss of $0.14, impacted by the IPR&D and milestone charges I noted, higher amortization costs associated with the acquired inventory fair value step-up adjustment for [indiscernible] from the Riata transaction and SYFOVRE the EMPAVELI from the Apellis transaction as well as restructuring costs related to the Apellis acquisition.

Now turning to cash flow and the balance sheet. We continue to generate strong cash flow with $600 million of free cash flow generated in the third quarter of 2026. We exited the quarter with $1.3 billion of cash and $6.4 billion of net debt. During the third quarter, we repaid $400 million of the term loans related to the Apellis acquisition. We have now repaid $600 million in total and continue to expect to repay the remaining $1.4 billion of term loans by the end of 2027.

Now turning to guidance. As you heard this morning, we've continued the good business momentum in the third quarter and importantly, remain on track to deliver top line growth for the first time in several years. We have been encouraged by the faster synergy capture from the Apellis acquisition, resulting in favorability in the expected 2026 dilution. We are pleased to be raising the lower end of our reported full year 2026 non-GAAP diluted EPS range to between $12.20 and $13.

The business performance from the third quarter also reflects strength from execution, including acceleration of revenue from the pace of conversion from the high dose regimen of SPINRAZA in Q3. We also expect some typical Q4 phasing as well as SKYCLARYS inventory dynamics I spoke about a few moments ago and continue to expect lower contract manufacturing revenue in the fourth quarter due to timing of batch commitments.

Reflecting on where we are today in relation to core operating expenses, we are pleased to have captured some of the appellate synergies faster than expected. Core OpEx guidance reflects the typical seasonally higher core OpEx spend in the fourth quarter and includes the planned investments to support the advancement of our late-stage pipeline and prelaunch activities. We also now accept approximately $50 million of acquired IP R&D in the fourth quarter.

We will continue to balance this investment as well as investing to support the commercial success of the growth portfolio while ensuring a keen focus remain on profitability. Please be sure to review this slide as well as our press release for other important full year 2026 guidance assumptions.

In closing, Q3 2026 was another strong quarter and a continuation of the momentum we've seen this year. Our growth portfolio has now exceeded the legacy MS portfolio for multiple consecutive quarters and the first full quarter of SYFOVRE and EMPAVELI demonstrates the strategic and financial rationale for the Apellis acquisition.

As we strengthened our portfolio, we are on track to grow our business next year as we also focus on important data reads from our pipeline to further strengthen our long-term growth potential.

With that, I would like to pass the call back to Tim to open us up for questions.

Tim Power

Thanks, Robin. Can we go to the first question, please, Cynthia.

Operator

[Operator Instructions] Your first question comes from the line of Phil Nadeau with TD Cowen.

質疑応答

Philip Nadeau

Congrats on the solid quarter. I wanted to ask about the upcoming linafilumab data in SE. I think that is now becoming a focus of investors. Can hydrogen discuss its confidence that those Phase III trials will succeed and maybe work into that the differences in the Phase III design versus Phase II?

Christopher Viehbacher

Priya, do you want to take that one?

Priya Singhal

Sorry. Thanks, Phil. So I think just stepping back, we recognize and acknowledge lupus is a very heterogeneous disease. We studied past trials -- and we've extensively put several strategies in place to optimize the outcomes. And I've discussed those in the past.

And I think to name a few. The steroid tapering, control of background standard of care meds. So I don't really have anything new to add to those strategies. We remain very close now both of them being disclosed in the first part of -- first half of December. So I'll just stop here and we look forward to seeing the data as well.

Operator

Your next question comes from the line of Chris Schott with JPMorgan.

Christopher Schott

Just a question on fulzartinab. I know you mentioned this a bit in the open remarks, but assuming positive data in AMR, can you talk a little bit about how you're thinking about the rate of market development and the ramp of the product. And again, maybe just to spend more time in this market. Just comment maybe a bit on how -- the Street is modeling this? And do you think the Street is kind of getting this right in terms of how big of an opportunity this could be.

Alisha Alaimo

Chris, this is Alisha, I'll take your question. So we've been spending a lot of time looking at AMR, and I also think we've been looking a lot at MVI as well, which I'll touch on briefly. But for AMR and actually just recently at ASN, the team really spoke to many of the transplant physicians that would potentially be treating patients for this disease.

And I have to say that they were very enthusiastic about sells of scientific MOA. And it really was incredibly positive conversations. When you look at AMR, we believe there's around 11,000 patients, and you have to also remember that not all of those patients will go on products, several of those patients will already be too late in their progression, but there's a very large cohort that will -- now currently, AMR will be treated in transplant centers and transplant nests see themselves as stewards of the graft.

So the interesting thing about this space is we know exactly who will be treating the patients. It's about getting the patients in there. The 1 thing that we've learned from EMPAVELI now that EMPAVELI has been working with transplants, is that in a lot of these centers, you have to be on protocol. Now I mentioned protocol because protocols can take time, which is why we've already hired a medical team that has already visited 100 transplant centers and they're already looking at how you get on the protocol as quickly as possible once you have an approval.

So when you look at the ramp, you're going to have to know a couple of the months out of the gate, you're going to have some centers that will start right away. You have others that will gradually come on. You're also going to have a bolus of patients that are already sitting in that transplant center. So typically, transplant patients are with the transplant center for approximately a year. They go back to their general Nets.

General mats are actually very good at monitoring for AMR. And they're also pretty good at already referring them into the transplant centers. So that system, though it's not perfect, is already there. So we know that we were already out of the gate have a good set of patients at launch, and we're already currently working on the second tranche of patients that you would get after you see that bolus.

And so when we look at the top 100 centers, like I said, right now, it's about educating and understanding the protocols and how quickly we can get on. And then for general NAVs, it's around how they consistently diagnose and do surveillance for AMR and ensuring that they refer them earlier versus later.

Now along with that ramp, obviously, we get a lot of questions about price. And you've probably seen what's been happening in the market with IGAN, but we do believe that pricing will reflect the significant value that Fels is going to have for patients. And when you think about pricing for the product, also keep in mind the dosing of felzartamab.

For example, in AMR, in year 1, they will have 12 doses. In year 2, they have 6.5 doses. So you're also going to see like what we saw with SPINRAZA, that first year is we were going to capture actually quite a bit of value for the patients as they go down to 6.5 doses in the second year. In addition to AMR, you have MDI.

Now we view MDI as incremental to AMR rather than a separate commercial market. And now that we've done more work on it, we can understand that physicians are also looking at MBI. We believe that this gives an additional 30% on top of that patient population of AMR. So the biggest opportunity for MBI will be for raising more awareness outside of [indiscernible].

Right now, KMs understand it greatly, but it's currently an underappreciated disease that we have some time to work on, but we've already started those conversations.

Operator

Your next question comes from the line of Brian Abrahams with RBC Capital Markets.

Brian Abrahams

Congrats on the quarter. Maybe another question for Priya on [indiscernible]. I know you guys have already presented some of this, but can you elaborate a little bit more on how you view the baseline characteristics of patients who enrolled in TOPAZ-1 and 2 as comparing to the Phase II study, in particular with respect to interferon gene signatures.

Priya Singhal

Thanks, Brian. Just stepping back, I think interferon gene signature across the board, we expect it to be high in SLE patients, and that is what the literature supports as well. And really, from a baseline perspective, there aren't any differences that we are aware of in terms of LiLAC versus TOPAZ-1 and 2 on interferon gene signature. We'll only know afterwards when we look at the data, and this is areas we'll be examining carefully. .

Operator

Your next question comes from the line of Umer Raffat with Evercore.

Umer Raffat

I wanted to focus on the SLE trial as well. Priya, when I look at the Phase II data, 1 thing that stands out on the SRI-4 endpoint is that the entire delta this entire separation versus placebo was driven by sort of 1 subcomponent, which is led to again. I'm sure you're very familiar with that as well. How are you thinking about the relevance of that finding heading into Phase III?

Do you still expect it to be [indiscernible] driving it or additional components as well? And will you be in a position to pull data across both studies by interferon high subgroup, if needed, because there's other companies in the space commenting on that even in a scenario where 1 of the trial does not hit stats.

Priya Singhal

Yes. Thanks, Umer. I think just stepping back, I think we believe that SRI-4 is the right primary end point when we designed the trial, given that our focus is on skin and joints and how it kind of measures outcomes. So I think from that perspective, we think that's right. Yes, I think we will have the opportunity once we see the data to decide how we might pull and what aspects of these trials should be combined.

And I think this will be data dependent and also dependent on conversations and discussions with regulators. So we wait to see the data. And of course, we plan ahead of that, but we wait to see the data now.

Operator

Your next question comes from the line of Salveen Richter with Goldman Sachs.

Salveen Richter

Could you speak to how much of an increase in commercial injections for SYFOVRE due to reducing free drug use versus demand? And also with regard to the education campaigns, as you look to improving the discontinuation rate, maybe help us understand what is resonating with physicians and patients and where the remaining barriers are.

Alisha Alaimo

Salveen, this is Alisha. Thank you for the question. The team has done actually a phenomenal job with lowering the free goods on this product. But that's been throughout -- ever since we did the acquisition. So we identified that as a potential area of improvement before we had even acquired them. The team has done a nice job of that. .

But when you look at the commercial injection growth, especially year-over-year, we do tie this to the fact that the SYFOVRE team has also done a very nice job on improving the sentiment on treating GA in general and sewing lesion progression. In fact, I went to 1 of their large conferences and met with many of the PE firms and with the retina specialists. And the sentiment they say across the board has improved quite a bit. and they are now more willing to do more injections.

And so these commercial injections are coming from also more HCPs that are coming on board and more depth of prescribing as well. Now I have mentioned before that the discounts after that first month of injection is quite high. We are just now putting into place a lot of those tactics to try and address that. And I have to say that the biggest problem is this, when I talk to a physician or we do patient market research, patients aren't really explained what to expect when they get the injection.

And if you compare it to wet AMD, which by the way, 40% of GA patients also have wet AMD, they're expecting everything to clear right away. They don't understand the slowing of progression. So when they get the injection, they feel like, oh, that doesn't work, they don't come back. And so there's an educational piece there that we're putting into place, not only for patients, but even for office staff and also really talking to the physicians.

And when you talk to the retina specialists, they don't actually realize that these patients have dropped off at month one. So I do think once the education goes into place, we are going to see quite a nice lift on that when they start educating the patients. The other part of that is going to be around. I've mentioned this before, now that we had a very strong quarter and not only grew in revenue but also grew in the volume we believe DTC is going to be a great strategic lever.

And we noticed that because they were in DTC a while ago for SYFOVRE. And actually, the results of it was very good, saw a direct impact into patients going in and requesting the product. And then for whatever reason, they have, of course, stopped it. But now that they are in Biogen, we decided to kick that back up again. We already have a concept. We shared it with Chris. We think it will be a very good DTC, and we hope to launch the next year, and we do believe we'll drive even more patients into doctors' offices.

Operator

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

Michael Yee

Maybe just a question on the cutaneous lupus readout in the first half. Maybe you could just comment prior Chris, on your confidence in that indication in that program versus the systemic indications, which I think people would view as a little bit higher risk and thinking about either the target, which is different than dapolizumab, for example, and just your overall confidence in that study, I know you appreciate your [indiscernible] 1 study here versus systemic 2 studies. So just wanted to think about how you are framing the cutaneous readout.

Priya Singhal

Yes. Thanks, Michael. I think just stepping back, we believe that both SLE and CLE are high unmet need areas. We also think that the mechanism of action, as we saw in -- from LiLAC in Phase II, we see that the drug has activity in both forms of the disease. I think just stepping back, it's too close really now, and I don't want to speculate, so I'm not going to really talk about confidence.

We know that systemic lupus is generally more heterogeneous. So I think that's the area that I spoke about earlier as well as to what are the strategies we put in to really address the variability that we see. Moving to cutaneous lupus. This is obviously a visible condition. It's easier to kind of visualize and see impact.

So I'll just stop there. But I think, overall, we believe both are important, high unmet needs, and we're going to see data in both these indications, and we have seen data in Phase II. So we'll wait to see what we get in Phase III.

Operator

Your next question comes from the line of Alex Hammond with Wolfe Research.

Alexandria Hammond

So for SPINRAZA high dose, can you characterize what levels of conversion you see in the United States and at steady state where you expect this to fall. As a follow-up to, does it give you confidence on the commercial dynamics for salinersen, assuming a positive Phase III result, I think, in '28.

Alisha Alaimo

Thank you, Alex. This is Alisha. We are really pleased with the performance of SPINRAZA high dose. In fact, for anyone that looks at the rare disease launch benchmarks, SPINRAZA 12 mg used to be the benchmark for the best rare disease launch ever. And now it's actually SPINRAZA high dose. And we do believe this has now set a new bar also for efficacy.

The one thing about this community that is so special is number one, they know every trial that's coming out -- they know every physician and when they want something, they ask for it. So a lot of what you're seeing with SPINRAZA high dose is really coming from the community, pulling it and asking doctors for it. And not just in the U.S., by the way, I want to say both of the other regions, both Europe and ex U.S. and Europe, we are seeing similar results across the board with SPINRAZA and all of the launches across the board have been successful.

So if you look at our start forms, which is basically the intent to get the prescription for the patient. At the end of Q3, 70% of the 12 mg patients now have a start form submitted which is very high. And we know that 50% have now been dosed to the product. That means that they've pulled forward quite a few of these patients. And clearly, we're not in Q4 yet. But as you can imagine, even more of those patients will now land in Q4. That means for next year, there aren't as many patients that will be getting that onetime benefit of the 90,000 that you're seeing this year with every transition dose.

Now the other thing that we are seeing, and this is also across all regions is that you're seeing patients come back. So they've been on SPINRAZA. They went to a competitor, and then we call that a switch back. So we have seen a portion of the patients switching back. We've also seen a portion of patients either being dosed right before there's old gens or after Zolgensma.

So there's a market there that we will be looking at next year on switchbacks and on new patients that will go beyond the transitions. Now with that being said, what's our goal of SPINRAZA high dose is to maintain the patients that we currently have, especially as we approach a potential launch of salonersen, which I have to say, the community already knows about salinersen and patients are already asking about it. So we also believe that, that will be a very large commercial opportunity for us if we do get an approval for it.

Operator

Your next question comes from the line of Paul Matteis with Stifel.

Paul Matteis

I wanted to throw one in on zuvenorsen ahead of data next year. Can you talk about the work you've done to garner conviction in pricing that drug at a premium outside of the U.S. where antiepileptic medicines are generally not that expensive. And as it relates to the thesis there, how core to that thesis is actually showing a static effect on cognition in the Phase III DRIVE study?

Tim Power

Yes, Paul, I think the -- there is opportunity to reprice this market. And the real differentiation is the impact on cognition, as you said. So as we -- I think we've already talked about that this is a an addressable market of at least $1 billion outside the U.S. And obviously, we need to see the Phase III results. But I think if they replicate the Phase II. And I do think we have a pretty compelling proposition to take to payers in Europe.

Operator

Your next question comes from the line of Evan Seigerman with BMO Capital Markets.

Evan Seigerman

Always congrats on the really nice progress. I want to touch on [indiscernible] just given the growth we're seeing there. In the field, what's the feedback from both patients and providers regarding iClick. Are they -- is it driving the uptake that you would hope it would have? And then thinking ahead to next year, what else can you do to expand the market and continue the growth.

Alisha Alaimo

Thank you, Evan. This is Alisha. Very excited that you asked about what can be [indiscernible] I think first, I would like to address, if you don't mind Part D because those are the questions we had quite a bit over the last couple of quarters. And if you have been able to look at the published formularies already, you're going to see that Part D, as Robin had also mentioned, we have at least 50% coverage, which I have to say during this time, especially post IRA, Part D plans have been quite restrictive. .

So we're very pleased with where we are with Part D. Also keep in mind, it's an open enrollment right now. So I can't actually tell you the total lives because 30% are still flux. So even though we know of 50% now, we do believe that we will have greater than 30% going into January of next year, which is better than what we had expected to have for next year. So that is very good news.

Now when you look at how iClick is performing, I think that what you're going to see is it's really reframing the convenience conversation. And this is actually a critical moment for LAC to become more accessible and easier to start for patients. And in the longer term, which we've said before, we believe iClick is 1 of the only things that we have that will actually grow the market in general for the entire class.

Now if you look at DBD data, which I know many of you buy, it doesn't have a great capture rate. It is going to show really astronomical numbers for how they capture it. I'd say, don't look at iClick eyes for the DBD data. But when you do look at how it's performing in market and you compare it to, let's say, the LEC IV launch or Casinla, iClick Eye is outpacing the LECIV launch by 3.5 and Kasumi by 6 times.

Now these are early days. And so you are going to see that some of that is going to be orders going into certain IDNs and maybe embolus of patients. However, the interesting thing that we are seeing that we haven't seen before, I click, of course, the majority you're going to see come from Lacombe writers and also dual writers.

But we are now seeing writers who have never written in AAT before, never written cast, never wrote like IV, they're writing iClick, and we are also seeing physicians who have only ever written Cassia right click. And so you're starting to see a dynamic change, especially in areas where there's long drive times. For example, the fastest uptake that we have is on the West Coast, where you're seeing really a lot of space and geography. And you're also seeing the convenience factor happen as well.

And so with that being said, I think that this year, right now, it's outpacing what our were. It is early days. And as you look at next year, I think that we're going to see that subcu has now become a really tremendous option for both patients and physicians. And for physicians to write it that have never written in AAT before is a very good signal to us that this can be very promising for next year and the years beyond.

Operator

Your next question comes from the line of Geoff Meacham with Citi.

Geoffrey Meacham

For the question. bigger picture 1 for Chris. It looks like the return to top line growth is durable, lots of interest in the pipeline. I guess the question is when you think about capital deployment, what would you prioritize? Is it further expanding fultartinib development, for example, more commercial investments in SYFOVRE or EMPAVELI Pavel or staying aggressive in [indiscernible]. Just want to get kind of the internal to external balance from you looking forward.

Christopher Viehbacher

0 Yes. Thanks. Well, there's no question that if -- obviously, we have to wait until the clinical trial results, but we are looking at these 10 Phase III launches or 5 NME launches. Now part of the rationale, remember for acquiring Apellis was already to acquire a commercial team for felzartamab.

Now that doesn't mean we wouldn't want to expand that. further, but it's not going to be a -- we're starting from scratch type investment in that space. Lupus, I would suspect is going to need a lot of investment, a lot of education zorvinersen, I think, is really a limited population that's going to look a lot more like a rare disease and salinersen also comes in behind the SPINRAZA.

So as we grow the business, I think our objective is clearly to invest not only in commercial, but continued investment in R&D. But equally, I think investors have waited a long time for us to grow. And so we're going to be very mindful of different ratios and the amount of investment versus growing our bottom line. But -- and I think we can manage all of that actually.

So we will invest in our continued success for sure. In terms of external, as I was saying earlier, I think we're really focused on the early stage. This is the most capital efficient time to introduce new assets to a company. I really always hated having to go buy assets in later stage because there's still a fair amount of risk associated with that.

And I think if we have reasonable success with the pipeline, again, we have to wait and see the results, but there is a good potential that the company can just grow now for the foreseeable future. So that's why we're focused on really growth into the next decade. And there, we have the time to grow the assets. And so we're looking a lot at D.C. to Phase Ib, I would say it's probably our sweet spot.

We've been fairly intentional about M&A over the last 3 years. we have looked at everything and filtered through everything. We're not being as intentional now, but we can still be opportunistic. If we see something that would add to 1 of our existing franchises One of the things I'm quite mindful of is distraction.

We have dramatically changing Biogen. Four years ago, we really only called on neurologists. And now our regional teams are looking at retina specialists, nephrologists, transplant nephrologists. With lupus, it will be we're looking at dermatologists and rheumatologists. We're looking at potentially epileptologists with reserversen.

So that's we really expanded the whole commercial organization. We are busy recruiting an awful lot of capability out of the top 150 executives in the company, about half have joined in the last 3 years. So all of that is a tremendous amount of change, and I think we really want to be able to digest that change and really take advantage of the opportunities that are in front of us and be careful about overextending ourselves. So that's how I'm thinking about it.

Operator

Your next question comes from the line of David Amsellem with Piper Sandler.

David Amsellem

So wanted to ask a commercialization question on lidafilimab, and I realize that might be putting the cart before the horse here, given the data readouts. But wanted to get your thoughts on how you're sizing the CLE opportunity relative to the SLE opportunity bearing in mind that many patients with cutaneous disease have systemic disease, although there's no therapies approved for cutaneous disease or it's a much -- there's a dearth of treatment options, of course, there. So how are you thinking about sizing in terms of the 2 opportunities? And how distinct do you look at these 2 opportunities?

Alisha Alaimo

Thank you. This is Alisha. I think, first of all, the way in which we view these is they are separate opportunities. So if you look at CLE, there's 250,000 patients that have CLE only, where when you look at SLE, there's 300,000 patients that have SLE only, there's 50,000 patients that have both.

So CLE in totals 300,000 patients. When you also look at CLE, the way the team has phrased it, the CLE is life-changing for a patient and SLE it is life ending. That means that they are very different markets. In CLE, less than 5% are actually treated, which is different than SLE, which you know is around 30%. There is a split across rheumatology and dermatology with only 1/3 of these patients being managed by dermatology. And what ends up happening with the patients is that specialists will refer to each other.

So the patients then get left waiting while the damage continues to go because they sort of get stuck in the middle. If you talk to a physician for CLE what they want to happen for a product. So if they were to prescribe because right now, they don't prescribe the biologics for this disease, they really want to make sure the drug works, it's safe, and fairly easy to use.

They don't want a lot of monitoring, and they want to be able to access it very quickly, which means patient services becomes quite important in this disease state. The patient goal is they just want some sort of visible improvement. So this will be before they have a permanent scarring before they have hair loss or before there is really a major disfigurement, especially of their face. So in this area, our push is more to get the dermatologist to treat where with SLE, rheumatologists are already treating.

So we want to make sure dermatologists have the empowerment and that they treat early and urgent and we need to simplify this diagnosis for them so that patients aren't experiencing any of these horrible irreversible damage that they talk about so much, and then accelerate the adoption of the higher efficacy treatment. So what we don't want to see in dermatology, like what you see in rheumatology is them waiting.

And we believe because derms already prescribe biologics in other parts of their business. that they will end up picking up these products at a fairly good clip once they understand how they work, how to access them and once we're on formulary. So we do look at it a little bit differently than we look at SLE.

Operator

Your next question comes from the line of Danielle Brill with Truist Securities.

Danielle Brill Bongero

Maybe I'll actually ask one on IgAN. So with the FDA now open to a 1-year eGFR endpoint and the April as agents becoming the standard of care, are you reconsidering design, including the 2 years on placebo. And then if you do shift to a 1-year eGFR endpoint, would the trial still be adequately powered?

Priya Singhal

Thank you, Danielle. Just stepping back, I think we have assessed that while proteinuria remains a very relevant marker of disease activity as well as EGFR really provides a more clinically meaningful measure of long-term renal outcomes. So we are actually planning to stay current and ahead by updating our primary endpoint to EGFR to reflect the evolving evidence base and the increasing importance of directly assessing kidney function and IDM.

So we're going to -- we're already embarking on this change. We think that the change is going to align the program with the current treatment landscape as well as regulatory expectations and will allow us to more clearly characterize the potential benefit of [indiscernible]. But in addition, I would say that we continue to hear and get reinforcement on the fact that the drug holiday and ability for patients to be off drug while staying in remission is very important.

So this continues to be a very important differentiator or felzartamab in IgAN. So we'll continue to keep both those aspects in mind as we reflect these updates.

Operator

Your next question comes from the line of Mohit Bansal with Wells Fargo.

Mohit Bansal

Congrats on the progress. Just trying to understand the guidance a little bit here. If I do like a plain math of like 5% growth, assuming that's what you mean by mid-single-digit growth and subtract the 9 months of sales. It seems like you are modeling quite a lot of drop sequentially in fourth quarter versus third quarter.

I get about $30 million is talking, but what are we missing? Because it seems like a lot of drop from third part to fourth quarter. So to understand how you are thinking about it.

Robin Kramer

Yes. So thank you for the question. So when you look at the Q3 results, as I noted in my remarks, on a top line basis, we noted that we did have the significant tailwind as Alisha pointed out, with the conversion rate on SpinHD. And so we saw a pull forward of conversions that we expected to occur in Q4 to the Q3 time frame as well as some of the inventory dynamics I mentioned as it related to [indiscernible] and some of our other products. So from a top line perspective, we had this positive pull forward. The guidance update and where we've landed is factor.

You might recall in the last earnings call, we did raise our guidance. In the current quarter, we're lifting the lower end of the guidance range, and that's driven primarily by the appellate integration and the success we've had there, both the top line performance as well as the earlier capture of the synergies on the expense side.

Operator

Your next question comes from the line of Andrew Tai with Jeffries.

Unknown Analyst

So on SLE, if litafilumab and DAPI both succeeded. Can you remind us how these 2 drugs would be positioned relative to each other as well as the competing drugs out there? And what would be the reasons to believe why either drug could be used as a first-line therapy ahead of standard of care?

Alisha Alaimo

This is Alisha, I'll take that answer. So we're working on positioning right now for both of these products, especially if we are fortunate to have both of them be approved, which, by the way, gives us 2 shots on goal for SLE, which we also find critically imprudent. We also believe that they may offer some differentiation.

So for example, we do know that DAP has shown improvement in fatigue and we know 1 of the major complaints from SLE patients is fatigue. Now when it comes to first line, say, there's going to be a lot of competitors, but depending on how the data reads out, I believe that the way that you will have a success in lupus it will be directly correlated to how you address the barriers that these physicians and patients are going up against.

So it will also be data dependent. However, what the current organizations have not been able to do is actually address barriers on why they're waiting, as Chris mentioned, waiting on prescribing products. The patients haven't been activated to go in and ask for these products.

And so I also think with the commercial powerhouse that Biogen has been able to create over the last 7 years with all of the 7 launches that we've had, we also believe that the commercialization, how you market the product will become just as important. And so it remains to be seen, but with 2 shots on goal, I think we're going to be able to compete to win pretty well.

Christopher Viehbacher

And here, again, I think Biogen has a lot of experience. We've had multiple products in the MS portfolio, for instance, and have been able to find exactly which patients benefit from which product at the right time. So I think that will transfer to lupus as well, if we are fortunate enough to have both of those products.

Operator

Your last question comes from the line of Marc Goodman with Leerink Partners.

Marc Goodman

I heard your comment on inventory with Sky Claris, but could you just give us a little more detail just on what you meant by growth? How much growth are we seeing in patients in the U.S. and just give us a little bit of a dynamic going on overseas because it's kind of country by country and what's come on and what's still to come on, what's growing, what's been reimbursed? Just give us a little more detail there.

Alisha Alaimo

This is Alisha. I'll take the first part of the question, especially around the U.S. We're encouraged by our 2026 performance with Sky Claris especially as we continue to grow year-over-year. We do believe we will continue that growth moving forward. there's a couple of dynamics at play, especially in our organization.

I think first and foremost, the patient finding tools that we have now and the AI predicting where these patients are and the way in which the teams collaborate to find them has really gotten to a level, I think, of 1 of the most efficient models that I have seen. And so they've done a very good job of finding those patients and getting them on product.

The other thing that the team has done very well is in the beginning, we had a very high discount rate off of Sky Claris. That is now normalized at a much lower percentage than what we've had before, and we're seeing the discounts continue to sort of stay flat as we move through the rest of the year. So we believe that we will continue to grow year-over-year, but more importantly, the pediatric expansion represents the next meaningful opportunity for us for a growth inflection as we look ahead.

Robin Kramer

And -- this is Robin, and I'll speak to the ex U.S. dynamics. We expect from a demand perspective that the growth on both the remainder of this year and into next year is primarily going to be coming from the continued expansion of SkyClaris globally. We continue to launch in new jurisdictions, including the recent approval in Brazil. And so that's where the future growth from a demand perspective is focused on.

Tim Power

Thanks, Robin, and thanks, everybody, for your participation today. If you've got more questions, just reach out to us at the IR team here at Biogen. Thank you.

Operator

This concludes today's call. Thank you for your participation. You may now disconnect.