シーラス（CERS）2026年第3四半期決算説明会：増収、RedeS結果、業績予想

主要なポイント

• Cerus Corporation（NASDAQ: CERS）が発表した2026年第3四半期の製品売上高は、前年同期比10%増の5,770万ドルとなりました。米国におけるINTERCEPT血小板およびIFCの需要増と、EMEAにおけるINT200 Illuminatorの設置進展が牽引しました。
• 北米の製品売上高は12%増加しました。一方、EMEAの製品売上高は、地政学的混乱やフランスからの注文遅延、約2%の為替の逆風があったものの、報告ベースで5%増加しました。
• IFCの製品売上高は、前年同期の390万ドルから560万ドルに増加しました。当四半期のIFC出荷の90%をキットが占めており、より高粗利益率のキット専業モデルへの同社の移行を裏付けています。
• Cerusは、2,300万ドル〜2,500万ドルのIFC売上高を含む、2026年通期の製品売上高見通し（2億2,900万ドル〜2億3,100万ドル）を据え置きました。
• 第3四半期の調整後EBITDAは570万ドルに達し、10四半期連続の黒字となりました。営業キャッシュフローは300万ドルとなり、Cerusに帰属するGAAP純損失は100万ドル未満にとどまりました。
• 第3相RedeS試験は、INTERCEPT処理済みの赤血球における主要有効性エンドポイントを達成しました。Cerusは、申請書類にRedeS臨床試験のフルレポートを追加した後、2027年後半にCEマークの承認を取得すると見込んでいます。

主要財務データ

事業および業績の動向

北米地域は第3四半期の製品売上高の3分の2強を創出しました。経営陣によると、血小板キットの数量および試算された血小板投与回数は前年同期比で5%増加し、市場全体の成長ペースを上回りました。Cerusは、Blood Centers of Americaとの全米規模の協定が、新規顧客の獲得ならびに血小板とIFCの双方の採用拡大を引き続き後押ししていると述べています。

IFCは引き続き主要な成長ドライバーとなっています。投与量換算ベースでの販売数量は前四半期比で7%増加しました。Cerusは、IFC完成品の病院への直接販売から、血液センターを通じたキット販売へと移行を進めています。キットの単価は低いものの、経営陣は粗利益率が改善し、病院顧客へのアクセス範囲が広がると述べています。同社は、2027年には実質的にすべてのIFC売上がキット形態になると見込んでいます。

EMEAでは、INT200 Illuminatorの設置台数が経営陣の予想を上回り、当四半期の成長を牽引しました。しかし、ロシアからの注文はロシア・ウクライナ紛争の影響を受け、フランスのEFSからの注文は延期されました。経営陣はEFSの発注パターンが正常化すると予想しており、第4四半期もINT200の設置モメンタムが持続すると見込んでいます。

第3相RedeS試験では、INTERCEPT処理済みの赤血球が従来の赤血球に対して調整後ヘモグロビン増加量における非劣性を示し、主要有効性エンドポイントを達成しました。治療群で観察されたINTERCEPT赤血球特異的抗体を含め、治療期間中に発現した有害事象において、治療群と対照群との間に統計的有意差は見られませんでした。Cerusは、この抗体には臨床上の影響がなく、過去の試験結果と一致していると発表しています。

業績見通し（ガイダンス）

Cerusは、2,300万ドル〜2,500万ドルのIFC売上高を含む、2026年通期の製品売上高見通し（2億2,900万ドル〜2億3,100万ドル）を据え置きました。政府契約による売上高は、売上高見通しおよび非GAAP調整後EBITDAのいずれからも除外されています。

経営陣は、近年の米ドル高により第4四半期の粗利益率が一定程度改善すると見込んでいます。また、IFCのキット販売への継続的なシフトも、連結利益率の下支えになると期待されています。

Cerusは現在、自社の赤血球システムのCEマーク承認取得を2027年後半と見込んでいます。承認が得られ次第、同社はより広範な事業化に先立ち、主要な一部の血液センターに絞った欧州での限定的な市場投入を実施し、実臨床での実績を積み重ねる計画です。

リスクと今後の注視点

中東およびロシアにおける地政学的紛争、フランスからの注文延期、ならびに為替の動きが、海外売上高の短期的な圧迫要因となりました。経営陣はこれらの逆風を一時的なものと位置づけていますが、解消の時期には不確実性が残っています。

米国のINT200血小板に関するPMA提出について、FDAは追加の情報およびデータを要求しました。Cerusは質問に対処可能と考えていますが、追加要件の範囲について同局と合意するまでは、承認時期は不透明なままであると述べています。

RedeS試験の副次エンドポイントは引き続き分析中です。Cerusは、FDAと米国の赤血球承認経路および時期について協議する前に、統計評価と臨床試験レポートの作成を完了する必要があります。

粗利益率は、価格設定とIFC製品ミックスの寄与により前四半期比で改善したものの、為替やインフレの影響も一部あり、前年同期の水準を下回ったままとなっています。

アナリスト質疑応答のハイライト

経営陣は、RedeS試験の完全な分析が2027年上半期中に完了する見込みであると示しました。最終レポートはFDAへの提出、ならびに学術論文の発表や学会発表を目的としています。その後、Cerusは規制上の承認経路とスケジュールについての明確化を図る予定です。

Cerusは、経営陣が主要な商用プラットフォームになると見込んでいる第2世代の赤血球システムを開発中です。同社はまずGen 1システムの承認申請を行い、デザイン作業が完了した後に別途Gen 2の申請を行う計画です。

ドイツ市場に関して、経営陣はドイツ赤十字社との血小板製造販売後試験「INITIATE」の患者登録が順調に進んでおり、顧客から好意的な評価を得ていると説明しました。また、血小板の安全性に関する国家政策の見直しが最終決定されれば、INTERCEPTにとって追い風となる可能性があります。

IFCに関して、経営陣は需要加速の要因として、Blood Centers of Americaとの協定、血液センターを通じた流通の拡大、医療従事者間での臨床教育、およびキットへの移行を挙げました。Cerusは、市場シェアの目標や2027年の売上高見通しは示さなかったものの、IFCが標準治療製品となる可能性があると考えています。

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 day, and thank you for standing by. Welcome to the Cerus Corp. Q3 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker, Tim Lee, Head of Investor Relations. Please go ahead.

Timothy Lee

Thank you, and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cerus.com.

With me on the call are Vivek Jayaraman, Cerus' President and Chief Executive Officer; Kevin Green, Cerus' Chief Financial Officer; and Dr. Nina Mufti, Cerus' Senior Vice President, Research and Development.

Cerus issued 2 press releases this afternoon, one announcing our financial results for the third quarter ended September 30, 2026, and describing the company's recent business highlights. The other announcing top line results from our Phase 3 RedeS study. You can access copies of both announcements on the company's website at www.cerus.com.

I'd like to remind you that some of the statements we will make on this call relate to future events and performance rather than historical facts and are forward-looking statements. These include statements regarding financial outlook and performance, our business strategy and priorities, expected growth and market opportunities, clinical and regulatory activities, product launches and expansion and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that can cause actual performance and results to differ materially. Please refer to the forward-looking statement slide accompanying today's webcast, today's press releases and risk factors in our Form 10-Q for the quarter ended September 30, 2026, which we will file shortly.

For important factors that can cause actual results to differ materially. We undertake no duty or obligation to update our forward-looking statements. On today's call, we will also be discussing non-GAAP financial measures, including non-GAAP adjusted EBITDA. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures to the extent reasonably available, please refer to today's press release and the slide presentation available on our website.

We'll begin today with Vivek providing a business update and corporate highlights, followed by Kevin to review our financial results and expectations for the rest of 2026 and lastly, closing remarks from Vivek. And now it's my pleasure to introduce Vivek Jayaraman, Cerus' President and Chief Executive Officer.

Vivek Jayaraman

Thank you, Tim, and good afternoon, everyone. We appreciate you joining us today. At Cerus, our mission is clear: to expand patient access to safer blood and establish INTERCEPT as the standard of care for transfused blood components globally. Our third quarter kit sales represent nearly 800,000 doses of transfusable blood. Each dose represents a step toward improving patient care and enable us to extend the reach of pathogen reduction technology globally. Earlier today, we announced positive top line results from our Phase 3 RedeS study. This is another important step toward extending our pathogen reduction technology to red blood cell transfusion.

Reflecting on my first quarter as CEO, I am more confident than ever in our team, our technology and the opportunities ahead. As noted, our mission is to establish INTERCEPT as the standard of care for transfused blood components globally. Realizing this mission requires us to drive sustained growth, deliver meaningful innovation and build a financially strong business that can self-fund ongoing product and technology advancements. From an operating perspective, we are focused on 3 core priorities that support our mission, delivering sustainable double-digit annual growth, advancing clinical and technological innovation and strengthening our financial foundation.

Our third quarter performance reflects meaningful progress across all 3 priorities. Furthermore, the team executed well despite having to deal with the dynamic geopolitical and macroeconomic environment that created some near-term headwinds. Taken together, our quarterly performance demonstrates the value of our product and geographic breadth, along with the resilience of our team and their ability to navigate near-term obstacles. We are generating strong growth across our core franchises, are successfully transitioning our IFC business model and our international rollout of the INT200 Illuminator is exceeding expectations.

With the completion of our Phase 3 RedeS trial, we have built the largest library of clinical evidence in support of pathogen reduction technology in red cell transfusion. Financially, we delivered our 10th consecutive quarter of positive adjusted EBITDA, improved our margins and generated $3 million in positive cash flow. I am proud of our team's performance this quarter. We will now discuss each of these 3 pillars in further detail. Worldwide product revenue increased 10% year-over-year with U.S. performance leading the way. We witnessed continued momentum in our IFC franchise as well as gains in our core platelet franchise that solidly outpaced underlying market growth.

International placements of the INT200 Illuminator also contributed to growth and helped set the foundation for further kit penetration. North American sales increased 12% and accounted for just over 2/3 of third quarter product revenue. INTERCEPT for platelets continues to be the standard of care in both the United States and Canada. In fact, INTERCEPT platelets are now used at all leading U.S. hospitals that are recognized in the latest U.S. News & World Report rankings. Our collaboration with Blood Centers of America, or BCA, is helping broaden adoption.

As a reminder, we entered into a nationwide agreement with BCA at the beginning of this year and BCA member blood centers account for more than half of all blood products distributed in the U.S. While many BCA members were already Cerus customers. The agreement has created opportunities to deepen those relationships, while also allowing us to secure new customers across both platelets and IFC. Through the first 3 quarters of the year, revenue growth from BCA member blood centers outpaced overall North American growth.

Turning to IFC. Hospital demand continues to increase as our value proposition gains traction. Immediate access to fibrinogen and a 5-day post-thaw shelf life offer compelling benefits to clinicians, hospital administrators and most importantly, patients. The longer shelf life can materially reduce waste, while the availability of pre-thawed IFC can support more timely treatment in critical bleeding situations. Medical education remains important to expanding adoption. At the recent Association for the Advancement of Blood and Biotherapies Annual Meeting, the team from Grady Memorial Hospital in Atlanta, shared their real-world experience with the INTERCEPT Blood System, including IFC.

The team at Grady first adopted IFC in September 2025. Now they keep a unit of IFC thawed at all times ready to be issued. Peer-to-peer exchanges are incredibly valuable and help clinicians learn from one another and better understand how IFC can fit into their clinical practice. We are also evolving our IFC commercial model to support broader patient access and more attractive economics. We are migrating from direct hospital sales to distribution via our blood center customers. I am pleased with the progress we made in Q3 with respect to the pronounced mix shift from finished goods to kit sales.

Kits carry lower unit prices, but offer more attractive gross margins and enable us to leverage the blood center distribution network, which greatly expands our hospital and patient reach. On a dose equivalent basis, IFC sales volume increased 7% sequentially. We are seeing continued strong performance in IFC, as we approach year-end and are highly confident that our IFC franchise will be a meaningful growth driver for years to come. In EMEA, our commercial organization continues to deliver solid performance in an increasingly challenging environment. Geopolitical conflicts in the Middle East and Russia, along with the strengthening U.S. dollar created some near-term headwinds.

We believe these headwinds are transient and that the underlying opportunity for our international business remains attractive. Unit placements of INT200 in EMEA have exceeded our expectations and contributed strongly to the third quarter sales. We expect the trend to continue in the fourth quarter, and I appreciate the international team's unwavering focus on customer support. Our second priority, advancing innovation builds on our commitment to drive clinical and technological advances that improve transfusion medicine. New products and expanded indications can bring INTERCEPT to more patients and increase our addressable market.

This afternoon, we announced positive top line results from our Phase 3 RedeS trial of the INTERCEPT Blood System. Completing the study is a significant milestone in advancing our progress to extend the application of our pathogen reduction technology to red cell transfusion. We are grateful to the patients, investigators, blood centers and Cerus colleagues, whose commitment made this important study possible. Over the past decade, pathogen reduction has become an integral part of the blood safety toolkit for platelets, plasma and IFC. We believe extending pathogen reduction to red blood cell transfusion represents an important opportunity to further improve transfusion safety and expand the reach of our technology.

RedeS compares the safety and efficacy of INTERCEPT-treated red blood cells with conventional red blood cells in patients requiring acute and long-term transfusion support. The study assessed the primary efficacy endpoint and 2 primary safety endpoints. RedeS met its primary efficacy endpoint, demonstrating non-inferiority in adjusted hemoglobin increment compared with conventional red blood cells. Adjusted hemoglobin increment is a commonly used measure of RBC transfusion effectiveness. In addition, when evaluating treatment-emergent adverse events in the RedeS top line results, including the INTERCEPT RBC-specific antibody seen in the treatment arm, there was no statistically significant difference between the treatment and control arm.

The antibodies seen were consistent with prior studies and resulted in no clinical impact. The RedeS top line findings add to the clinical evidence from the STARS, SPARC and ReCePI trials. We are encouraged by the efficacy results and we will complete the full clinical analysis to further characterize the study findings over the coming months. With respect to our CE Mark red cell filing, ANSM continues to review our application. We recently held a constructive meeting with ANSM and are preparing responses to the questions they raised. As part of our response, we will include a full RedeS clinical study report.

The decision to include the RedeS data into our package was well received by the ANSM and will provide more clinical evidence, thereby strengthening our submission. As such, we now expect CE Mark clearance in late 2027. Pending CE Mark approval, we are planning for a limited market release, targeting centers of excellence in Europe. Our initial focus will be a small number of leading blood centers with the goal of generating real-world experience, which will inform our broader go-to-market strategy and approach.

Turning to the U.S. We received preliminary feedback and questions from the FDA on our PMA platelet submission for the INT200 Illuminator. We believe these questions are addressable, although scope will require us to gather some additional data. We'll have more visibility on approval timing once we align with the agency on the scope of these incremental data requirements. Despite the delay, we remain confident in our ability to successfully navigate the regulatory process and bring these technologies to market. In parallel, we will continue to drive ongoing share capture in existing markets and further strengthen the body of real-world experience we are gaining with our technology.

Our third priority is to strengthen our financial foundation. We made good progress last quarter, and this is enabling us to self-fund investments in both market expansion and product innovation. As we grow, we expect to generate greater leverage from our established commercial infrastructure and improve our overall profitability. Our third quarter results reflect this momentum, as evidenced by our improving margin profile, our 10th consecutive quarter of positive adjusted EBITDA -- the generation -- and the generation of meaningful cash flow from operations. We will balance that progress with disciplined investments in the technologies and capabilities that support future growth. Our goal is to build a profitable business that can increasingly fund its own development and expand access to safer blood.

With that, I will turn the call over to Kevin to discuss our third quarter financial results in greater detail.

Kevin Green

Thanks, Vivek, and thank you to those joining us on the call today. On today's call, I'll be discussing our financial results for the third quarter of 2026 and our expectations for the balance of the year.

I'll start with product revenue. For the third quarter of 2026, we reported product revenue totaling $57.7 million, a 10% increase over Q3 2025. For the first 9 months of the year, product revenue increased 14% to $168.8 million compared to the first 9 months of 2025. The primary growth drivers during the quarter were increasing demand for IFC and INTERCEPT platelets in the U.S. as well as EMEA placements for our next-generation LED-based illumination device, the INT200. On a volume basis, North American platelet kit and calculated platelet doses increased 5% year-over-year, demonstrating we are continuing to take share as we outpace the underlying platelet market growth.

By geography, third quarter North American product revenue increased 12% compared to the same period in the prior year. In EMEA, third quarter product revenue, as reported, increased 5% year-over-year. The growth in EMEA shows the resilience and diversity of the business, as we did see some impact from the ongoing conflict between Russia and Ukraine on Russian orders and separately, deferred orders from the EFS in France, who, as a reminder, is at 100% platelet utilization and who we expect will continue more normalized order patterns going forward.

Furthermore, unfavorable foreign currency exchange rates negatively impacted reported EMEA revenue growth by approximately 2%. Switching now to the IFC business in the U.S. As we mentioned throughout the year, we've been converting the business from one in which we sell finished IFC therapeutic to hospitals to a business where we sell kits to blood centers who will then use our products to produce IFC and sell the finished therapeutic to their hospital accounts. As we complete the move to a kit-only model, we expect to see a benefit to our reported gross margins. While the finished biologics carry a higher selling price, the gross margin profile for our kit model is accretive to our consolidated gross margins.

Of the total IFC sales shipped during the quarter, 90% were in kit form, and we continue to expect that essentially all IFC sales will be in kit form in 2027. IFC product revenue for the third quarter was $5.6 million compared to $3.9 million during the third quarter of 2025. As Vivek mentioned as part of his prepared remarks, we saw a marked sequential increase in the IFC mix shift from finished therapeutic products to kits. Based on our strong year-to-date commercial execution and conviction in growth projections for the balance of the year, we are reaffirming our full year 2026 product revenue guidance range of $229 million to $231 million. Included in this range is full year 2026 IFC sales of $23 million to $25 million.

I'd now like to switch to government contract revenue, which, as a reminder, is not included in our revenue guidance or non-GAAP adjusted EBITDA results. Given the conclusion of the FDA contract in 2025 and the wind down of the BARDA 2016 contract, reimbursement for government-related R&D expenses declined year-over-year to $6.3 million from $7.5 million in Q3 2025. BARDA continues to be an extremely supportive partner for our RBC program and with the 2024 contract covering many of the activities related to RBC development. The funding from this ongoing contract provided a partial offset to the wind down of the prior contracts.

Turning now to gross margin on product sales. Our third quarter product gross margin was 52.4% compared to 53.4% during the prior year and 51.4% during Q2 of this year. These results were in line with our expectations going into the quarter. While foreign exchange rates and inflation continue to pose headwinds to our margins, pricing and product mix, namely the continued conversion to IFC kit sales, supported the sequential pickup. For the balance of 2026, we expect to see some relief in Q4 given the recent strengthening of the U.S. dollar.

Moving down the income statement. Total operating expenses for the third quarter totaled $36.2 million compared to $34.4 million for Q3 2025. Total operating expenses increased 5% compared to our product revenue growth of 10,%, as we continue to strive to deliver leverage in the P&L. The increase in total operating expenses was driven by a 10% reduction in R&D expenses, reflecting the completion of the RedeS study enrollment, lower development costs on the INT200 following the U.S. PMA submission and the completion of activities covered under the FDA contract, which concluded in 2025. Offsetting this were year-over-year reported increases in SG&A due to onetime credits received in 2025, artificially affecting the year-over-year comp.

For the third quarter, government-funded R&D expenses accounted for 31% of total R&D spend. As we've previously noted, we expect government-funded R&D expenses to increase as a percentage of total R&D spend. Let's now turn to the bottom line and non-GAAP adjusted EBITDA results. For Q3 2026 and 2025, GAAP net loss attributable to Cerus was under $1 million, approaching breakeven. On a non-GAAP basis, adjusted EBITDA for the third quarter totaled $5.7 million compared to $5 million last year. These results mark our 10th consecutive quarter of posting positive adjusted EBITDA. As an organization, we are committed to looking beyond adjusted EBITDA and have line of sight into achieving GAAP profitability.

Let's now turn our attention to cash flows for the quarter. Cash generation from operations was $3 million, driven in large part by close management of inventory levels from the first half. These results continue to strengthen our balance sheet. As such, cash, cash equivalents and short-term investments as of September 30, 2026, were $57.1 million, up close to $1 million from June 30th.

Before I turn it back to Vivek, I want to mention that our existing shelf registration statement is scheduled to expire. While we've not used the shelf since 2021, we believe it's a matter of good corporate governance to have one in place. And as such, we are refreshing it in connection with our third quarter 10-Q filing.

With that, let me pass it back to Vivek for some closing comments.

Vivek Jayaraman

Thank you, Kevin. Our performance through the first 3 quarters of 2026 reinforces my confidence in our business. We are driving growth via continued penetration in our core markets globally, are successfully transitioning the IFC business model while increasing unit volumes and gaining traction internationally with the continued rollout of the INT200. With respect to innovation, the positive top line results from RedeS added a strong library of clinical data we are building in support of red cell pathogen reduction and reaffirms our commitment to leading the way in terms of investment in scientific research and clinical evidence.

Lastly, our financial profile is strengthening as we are improving our margins, delivering positive adjusted EBITDA, generating cash flows and taking clear steps towards becoming GAAP profitable. What is most important, however, is that each unit of INTERCEPT-treated blood, that is produced takes us one step closer to realizing our mission. This quarter, our kit sales represented nearly 800,000 doses of transfusable blood components. This means more patients around the world are gaining access to safer blood. We are proud of our progress, but realize that there is much work yet to be done. I am confident that we will continue to deliver against our mission. Thank you for your interest in Cerus and for your continued support as we work diligently to improve the safety of the global blood supply.

Operator, please open the call for questions.

Operator

[Operator Instructions] Our first question will be coming from the line of Josh Jennings of TD Cowen.

質疑応答

Colin Clark

This is Colin on for Josh. Congratulations on the positive RedeS results. It was really encouraging to see. I was hoping you could talk a little bit about the next steps with FDA for Gen 1 RBCs. And I know you talked about the clinical process and analysis happening over the coming months. But what are the next steps there after that? And if you have any updates you could share with regard to Gen 2, that would be really helpful.

Vivek Jayaraman

Hey, Colin, thanks for the question, and I appreciate the positive commentary. We're certainly excited about the RedeS results, and certainly evidence of our commitment to investment in evidence generation. As you noted, next steps include the full data analysis, and that is to support submitting that clinical study report to the FDA, as part of the approval process and then also submitting it for publication and presentation of the podium. Once that report is finalized and we submit to the FDA, we'll then be able to sit down with them and get a better understanding of timing in terms of the approval process and the pathway forward.

In parallel, as you noted, we're working from a device development standpoint on our Gen 2 system, which we believe will be sort of the main go-to-market system. We made good progress through the third quarter. And as we enter into 2027, I think we'll be able to talk more about the specifics of that system. But right now, the focus is on taking this good top line data, doing the full statistical analysis and then meeting with the agency to discuss next steps.

Colin Clark

Got you. That's helpful. And I wanted to spend a minute on international. We saw a little bit of lumpiness come up in the platelet kit growth numbers and the change in the number of treatable platelets, kind of similar to 2Q. Can you talk about the underlying health of the international markets, kind of what that Russia-Ukraine dynamic impact looks like and potentially touch on whether you're seeing any distributor choppiness?

Vivek Jayaraman

Yes. Thanks. All great questions, and I think demonstrative of the good insight you have into our business. As we noted during the call, certainly, the geopolitical climate and some of the tensions in different parts of the world are impacting our business. As I mentioned earlier, we believe that this is transient. The fact is our position in those markets in terms of share and leadership remains strong. We've been working very closely with our distributor partners and with their hospital and blood center customers to do everything we can to ensure continuity of supply so that ultimately, patients have access to pathogen-treated blood.

The underlying impact in terms of long-term belief in the technology and the strength of our product remains unchanged, and we saw continued strong adoption of the INT200 international markets. So there are signals that we believe over the mid and long term are encouraging. It's just a matter of navigating some of these acute issues that we saw sort of manifest in the second and third quarter. And then the other contributing factor that I'd point to is Forex, which certainly the strengthening dollar remains a bit of a headwind, but ultimately, we're trying to focus on the things over which we have control, and that's really ensuring that we serve our customers well, that we provide quality product and we continue to deliver in terms of clinical education and market development. And we saw good progress in international markets this past quarter.

Colin Clark

I appreciate the response. Last one for me before I hop back in queue. I'm curious whether your experience at AABB was a bit different this year now that the BCA agreement is on board. Are you hearing about members with firsthand either PR platelet or IFC experience comparing notes? Or are there any opportunities with this buzz going on to get centers over the fence who are already considering becoming customers or get new opportunities to come your way?

Vivek Jayaraman

Yes. AABB was great. We were in Atlanta. I guess it's now last month since we've turned the calendar to November. But it was certainly, we're seeing tangible evidence of the BCA agreement, which we mentioned, really got underway officially being this calendar year. We're seeing that agreement bear some real fruit at this point in time. I think as mentioned before, peer-to-peer marketing is arguably the most effective tool in our toolkit. And we saw a number of new BCA centers jump on board, both in terms of IFC production and distribution, but then also platelet production and distribution as well.

And as we've noted, BCA members account for about 50% of blood products distributed nationwide, and that's where we had the largest room to grow in terms of both platelet and IFC adoption. So there was a lot of good dialogue between blood centers and then also their hospital customers in Atlanta last month. So we're certainly encouraged, and we believe that momentum will continue through '26 and really for years to come.

Operator

Our next question will be coming from the line of Mark Massaro of U.S. Bancorp BTIG.

Mark Massaro

I echo the congratulations on the positive Phase 3 RedeS data. My first question is around the -- what are your expectations for the ballpark timing of the full data analysis? Is that something that we could perhaps pencil in the first half of '27, just thinking about upcoming conferences and typical time line.

Vivek Jayaraman

Thanks for the question, Mark, and for the positive comment as well. I appreciate it. I think that's a reasonable expectation around timing. Obviously, as we get deeper into the data analysis, we'll learn more and during that time, that information is embargoed so that we can ensure we get the best possible audience in terms of clinical publication and ultimately podium presence. And obviously, we have to submit that information to the various regulatory bodies for their ongoing review and ultimate approval. But I think in broad brush strokes, that timing that you suggest seems in line with what we're driving towards. We'll certainly work diligently to get it out as quickly as possible, certainly not compromising quality in the interest of speed. But we're very excited about the library of evidence we've built in support of PR for red cell transfusions.

Mark Massaro

Okay. Fantastic. And then as we think about the full study results reporting out, just double checking, is it correct that the secondary endpoints have not read out yet? And do you remain blinded to those?

Vivek Jayaraman

Sorry, could you repeat that question, Mark?

Mark Massaro

Yes. The Phase 3 RedeS, we saw that you had successful on the primary endpoint. I'm asking about the secondary endpoints of the...

Vivek Jayaraman

Oh yes, sorry. Yes. No, that's correct. That's part of the ongoing analysis. We just reported this afternoon top line results from the primary endpoint as well as the primary safety endpoints with secondary endpoints and further data analysis will be distributed and published once we finish the complete analysis.

Mark Massaro

Okay. That's what I figured. And then obviously, you put up another strong double-digit quarter for product revenue. It might be a little early to talk about '27. But what I would like to get at is do you anticipate any potential structural challenges internationally? Kevin, feel free to weigh in here as it relates to some of your international business. I would expect continued strong growth from IFC next year as that product remains in early days of penetration. But just wondering if you could just help us frame some of the puts and takes as you're thinking about product revenue in 2027.

Vivek Jayaraman

Yes, certainly. And obviously, we'll demur in terms of guidance for '27 at the moment. But if I think about the performance in Q3, as you correctly noted, Mark, the U.S. business was really the acute source of strength, not only in IFC, as you mentioned, but also continued share capture for our core platelet business, driven principally by continued penetration within BCA members, on the heels of that BCA agreement. So that's encouraging across multiple dimensions, and we see continued strength in the U.S. as we continue through Q4 and head into the next calendar year.

We noted some transient headwinds internationally. And certainly, if anyone guess as to how some of these events may unfold. But even with those headwinds, we're seeing continued enthusiastic adoption of the INT200. That leads to further opportunities for improved kit penetration and growth. And then we continue to work on strategic market access in larger geographies, that we believe will manifest in terms of meaningful growth opportunities through the balance of this decade. So our overall enthusiasm for the international business and the evidence we're getting in terms of continued adoption and strong real world experience gives us long-term confidence. But I think my belief is the team is doing a nice job navigating acute headwinds. And while that's occurring, the U.S. business is really strengthening. So we're in a good spot, and I think that speaks to the value of a diverse portfolio.

Operator

And our next question will come from the line of William Bonello of Craig-Hallum Capital Group.

William Bonello

You talked a little bit about the Gen 2 device. Can you just explain how that would end up getting incorporated into the FDA process? Would that just be some kind of a modification to the FDA application along the way? Is it something that would have -- you get approved on the initial device and you go back afterwards? Just how should we be thinking about that?

Vivek Jayaraman

I think the latter part of your statement is how you should be thinking about it, Bill. We would -- we're applying for approval on the Gen 1 system. And then once we get past design freeze, all of the work on Gen 2, we will then submit for approval of that system, but it would be a follow-on to a Gen 1 device approval.

William Bonello

Okay. That's helpful. And then just in the past, you've been talking about what's been going on with the evaluation in Germany. Any update there?

Vivek Jayaraman

Yes. Thanks. Great question. So as we had noted in the past, we began the INITIATE clinical trial, which was in partnership with the German Red Cross, that was to evaluate the INTERCEPT system for platelets in a real-world setting in Germany. That study -- that post-market study continues to enroll at a healthy clip and the feedback we're getting from customers is quite positive. Separate and independent of that, there has been work at the health policy level in Germany by the PEI to look at what I would describe as something akin to the FDA's guidance on bacterial safety for platelets, looking at proposing a policy countrywide around how to ensure that platelet transfusions are as safe as possible.

And we certainly encourage that evaluation at the health policy level. We believe if that were, in fact, to go final, that would accrue to our benefit and be favorable in terms of how INTERCEPT is viewed in the German market. But independent of that, the INITIATE study continues to enroll positively, and we believe Germany will represent a pretty meaningful growth opportunity for INTERCEPT over the course of the rest of this decade. So things in Germany continue to go well.

William Bonello

Okay. That's great. And then just one more, if I could, flipping back to red blood cell. Again, just -- so you laid out, it was very helpful, both the sort of next steps between here and submitting for publication and submitting something to the FDA and some time line along with that. Can you just remind us of sort of how you see this evolving then over time? So fast forward to hopefully a time when you get FDA approval. What are kind of the critical steps that have to happen in the marketplace for red blood cell to become a big product? Do you need something like the FDA guidance document, but as it applies to red blood cell, what -- how are you kind of thinking about that? And is there any advanced preparation you do on that kind of stuff? Or is just the focus right now solely on the regulatory and the data?

Vivek Jayaraman

Yes. Very good questions, Bill, and I appreciate it. One thing I want to be explicit about, certainly don't engage in any sort of market awareness or development or priming prior to approval. So our acute focus is on getting the clinical study data final -- getting the study data analyzed completely, pulling together final clinical study report and then submitting it not only to the FDA, but for publication in the podium. I think that will facilitate meeting with the FDA and getting clarity on kind of the acute steps between here and approval.

The benefit of developing such a strong body of clinical evidence and support of red cell transfusion, so not only with RedeS, but if you think about SPARC and ReCePI, is that we are educating through clinical evidence generation, the broader market. And you add to that the fact that now between platelets, plasma and IFC, there's well over a decade of experience with pathogen reduction in blood transfusions. We think that creates an underlying desire for this product. We certainly get that feedback from customers all over the world.

And so what we're attempting to do, and we mentioned that in the context of the limited market release in Europe, post CE Mark, we will generate real-world experience with red cells and that real-world use even in geographies outside of the U.S., I think, will be informative and educational as we think about and approach U.S. commercialization. We see that -- the question was asked earlier about AABB. We saw that AABB where it's a fairly small industry in terms of influential blood center customers and clinicians. And so experience that has accrued in one market certainly has influence elsewhere. We're seeing this, for example, with our IFC rollout where the more experience and the progress we make in the U.S., we're getting inbound unsolicited inquiries from international markets about IFC. So I wouldn't be surprised to see a similar dynamic in play with respect to red cells once we're in a post-market environment.

Operator

[Operator Instructions] Our next question will come from Gabie, Cantor Fitzgerald.

Gabrielle Ingoglia

I want to double-click on IFC demand, because it was really impressive. It looks like volumes grew about 80% in the third quarter and 60% year-to-date. Could you just give some incremental color on what's behind that acceleration and which customer types are contributing the most?

Vivek Jayaraman

Certainly, Gabie, thanks for the question. It's great to have you on the call. As we had indicated, heading into calendar year 2026, we officially kicked off our nationwide agreement with Blood Centers of America. They represent over 50% of distributions of blood products nationwide and a number of BCA member blood centers were already partnering with us as IFC production partners heading into this calendar year. So as part of that agreement, what we are able to do is leverage their resource sharing model, transfer those production partners to BCA member agreements and then gain access to their network of sales and marketing and customer fulfillment professionals to effectively really scale and expand our reach into U.S. hospitals.

So that's a big underlying driver of our growth. It's really leveraging a broader SG&A network. In addition to that, as you can probably appreciate, is that with increased customer depth and user experience and leveraging podium and symposia opportunities with number of not only clinician conferences, but blood center conferences as well. The volume of center experience that's on the podium peer-to-peer dialogue that's occurring about IFC use and the value drives to patients is really starting to expand, which accrues to our benefit.

And then the other piece that we had mentioned is by virtue of transitioning to the kit model, it just allows us to more quickly penetrate accounts, again, through leveraging their channel and then also offers better economics for Cerus. And so it was really a combination of all of those factors that contributed. And it's still early days. We have a lot of headroom with respect to growth in this market. And so we view IFC as being a meaningful growth driver for the business really for years to come.

Gabrielle Ingoglia

Okay. That's helpful. And then I have that you guys lost estimated IFC share at about 10% last quarter. So just kind of leading into that response, where do you think it can go over the next few years?

Vivek Jayaraman

We certainly believe that IFC has the ability to become standard of care. That is our aspiration really across all of our product categories. And so there's no reason why, certainly, given product performance and clinical enthusiasm and most importantly, the impact that it has on patients, we believe it truly can be a life-saving intervention. So we certainly believe standard of care is something that we can deliver against, and it is our goal internally. So that's why I point to the fact that I think this is going to be a material growth driver for the company for years to come.

Gabrielle Ingoglia

Congrats on the positive RedeS read out.

Vivek Jayaraman

Great. Thank you.

Operator

And I have no further questions at this time. This concludes today's program. Thank you for participating. You may now disconnect.