Cuộc họp công bố kết quả kinh doanh quý 3/2026 của GRAIL (GRAL): Sản lượng Galleri tăng khi quyết định của FDA đến gần

Điểm nhấn chính

• GRAIL công bố doanh thu quý 3/2026 đạt 37,5 triệu USD, tăng 4% so với cùng kỳ năm trước. Doanh thu từ dịch vụ sàng lọc tăng 14% lên 37,3 triệu USD, trong khi dịch vụ phát triển đóng góp 0,2 triệu USD.
• Số lượng xét nghiệm Galleri vượt 56.000 lượt, tăng 24% so với cùng kỳ năm trước. Hơn 174.000 xét nghiệm đã được hoàn thành trong 9 tháng đầu năm 2026, tăng 36%.
• Chương trình khuyến mại giá đã kéo giá bán trung bình quý 3 xuống còn khoảng 660 USD mỗi xét nghiệm. Ban lãnh đạo đang ưu tiên tăng trưởng sản lượng và thâm nhập thị trường hơn là tối ưu hóa biên lợi nhuận trong ngắn hạn.
• GRAIL đã cập nhật dự báo tăng trưởng doanh thu bán hàng của Galleri cho cả năm 2026 lên 17%-21%, đồng thời duy trì dự báo mức đốt tiền mặt không quá 300 triệu USD.
• Hội đồng cố vấn của FDA đã bỏ phiếu ủng hộ Galleri. Ban lãnh đạo kỳ vọng cơ quan này sẽ đưa ra quyết định cuối cùng vào đầu quý 1/2027 và vẫn đang tích cực đàm phán về nhãn chỉ định với cơ quan này.
• GRAIL kết thúc quý 3 với 788,7 triệu USD tiền mặt, mức mà ban lãnh đạo cho biết đủ để duy trì hoạt động đến năm 2029.

Dữ liệu tài chính cốt lõi

Trong 9 tháng đầu năm 2026, số lượng xét nghiệm Galleri tăng 36% so với cùng kỳ năm trước, trong khi doanh thu tăng 24% do giá bán trung bình thấp hơn đã bù trừ một phần cho tăng trưởng sản lượng. Biên lợi nhuận gộp điều chỉnh trong giai đoạn này đạt 46%, so với mức 49% của cùng kỳ năm trước.

Kết quả kinh doanh và hoạt động

Sản lượng thương mại của Galleri tiếp tục mở rộng, dù số lượng xét nghiệm trong quý 3 thấp hơn đôi chút so với quý 2. Ban lãnh đạo cho rằng sự sụt giảm so với quý trước là do tính mùa vụ thường thấy trong quý 1 và quý 3, các thông tin tiêu cực liên quan đến kết quả thử nghiệm NHS-Galleri và thị trường cạnh tranh sôi động.

GRAIL đã triển khai chương trình khuyến mại giá vào tháng 9 sau khi tăng trưởng có phần chững lại trong hai tháng đầu quý. Công ty cho biết mức giá thấp hơn đã giúp thu hút các nhà cung cấp dịch vụ y tế mới và kích hoạt lại những bác sĩ từng ngừng kê đơn. Kênh phòng khám và hệ thống y tế đã hoàn thành các mục tiêu sản lượng quý 3 của công ty.

Lực lượng bán hàng phụ trách các nhà cung cấp dịch vụ y tế đã tăng từ 90 lên 120 đại diện vào tháng 6. GRAIL cũng hoàn tất việc tích hợp hệ thống Epic đầu tiên vào cuối quý 3 và kỳ vọng sẽ có thêm các hệ thống y tế khác triển khai tích hợp từ nay đến cuối năm và sang năm 2027.

Về mặt lâm sàng, kết quả các thử nghiệm NHS-Galleri và PATHFINDER-2 đã được công bố trên các tạp chí New England Journal of Medicine và Nature Medicine. Ban lãnh đạo cho biết các nghiên cứu này cho thấy số ca ung thư được phát hiện qua sàng lọc tăng từ 4 đến 6,5 lần, với gần một nửa ở Giai đoạn I hoặc II. Thử nghiệm NHS-Galleri không cho thấy sự sụt giảm kết hợp ở ung thư Giai đoạn III và IV, nhưng ghi nhận mức giảm 20% tỷ lệ mắc ung thư Giai đoạn IV trong một nhóm xác định trước gồm 12 bệnh ung thư có tỷ lệ tử vong cao và giảm 25% số ca chẩn đoán ung thư tại phòng cấp cứu.

Dự báo của ban lãnh đạo

• Tăng trưởng doanh thu bán hàng của Galleri cả năm 2026 dự kiến đạt 17%-21%.
• Dự báo mức đốt tiền mặt duy trì ở mức không quá 300 triệu USD cho năm 2026.
• Ban lãnh đạo kỳ vọng FDA sẽ đưa ra quyết định cuối cùng về Galleri vào đầu quý 1/2027, dù cơ quan này chưa đưa ra ngày cụ thể.
• Khi đạt quy mô lớn, GRAIL tiếp tục đặt mục tiêu biên lợi nhuận gộp điều chỉnh đạt 50%-60%, đã bao gồm phí bản quyền trả cho Illumina.
• Khoản phí bản quyền trước đây của Illumina vốn đang bị đình chỉ sẽ bắt đầu được áp dụng trở lại vào cuối tháng 12/2026. Ban lãnh đạo cho biết quý 1/2027 sẽ là quý đầu tiên chịu ảnh hưởng toàn diện từ khoản phí bản quyền này.
• Công ty dự kiến quy trình thẩm định IVDR tại châu Âu sẽ mất khoảng 12 tháng và hướng tới khả năng có kết quả trong năm 2027. Galleri hiện đã đạt được phê duyệt theo quy định UKCA tại Vương quốc Anh.

Rủi ro và các yếu tố cần theo dõi

Tăng trưởng trong ngắn hạn vẫn bị hạn chế bởi mô hình tự chi trả của Galleri, áp lực định giá, tính chất mùa vụ của sản lượng và sự cạnh tranh từ các xét nghiệm phát hiện sớm đa ung thư khác. Ban lãnh đạo thừa nhận rằng việc chỉ được FDA phê duyệt có thể sẽ tạo ra bước ngoặt tăng trưởng nhỏ hơn so với việc được bảo hiểm chi trả rộng rãi hoặc được đưa vào các hướng dẫn lâm sàng.

Chương trình khuyến mại giá đang hỗ trợ sản lượng nhưng lại làm giảm ASP và biên lợi nhuận gộp. Biên lợi nhuận gộp điều chỉnh quý 3 đã giảm xuống 42%, phản ánh ASP thấp hơn, chi phí sản xuất chung phân bổ tăng do thay đổi cơ cấu mẫu xét nghiệm và doanh thu dịch vụ phát triển sụt giảm.

Việc áp dụng trở lại phí bản quyền của Illumina sẽ tạo thêm áp lực giảm biên lợi nhuận gộp bắt đầu từ cuối tháng 12/2026. GRAIL ước tính công ty sẽ phải trả 2,6 triệu USD trong quý 3 nếu khoản phí bản quyền này không bị đình chỉ.

Khả năng được FDA phê duyệt vẫn chưa chắc chắn, bao gồm cả nội dung nhãn chỉ định cuối cùng. Thời điểm được NHS chi trả cũng chưa rõ ràng và sẽ phụ thuộc một phần vào các yếu tố ngân sách và chính trị.

Điểm nhấn phiên hỏi đáp với chuyên gia phân tích

Thời gian phê duyệt và nhãn chỉ định của FDA: Ban lãnh đạo cho biết các cuộc thảo luận với FDA vẫn diễn ra tích cực và thuận lợi, bao gồm cả đàm phán về nhãn chỉ định. GRAIL kỳ vọng mục đích sử dụng sẽ phù hợp với dữ liệu đã nộp đối với người trưởng thành từ 50 tuổi trở lên và dự kiến có thể trả kết quả cho bất kỳ loại ung thư nào được phát hiện. FDA chưa đưa ra ngày quyết định cụ thể.

Định giá và tăng trưởng năm 2027: Ban lãnh đạo từ chối đưa ra triển vọng về ASP hoặc sản lượng cho năm 2027. Công ty kỳ vọng ASP trong giai đoạn còn lại của năm 2026 nhìn chung sẽ duy trì tương đương mức hiện tại và đang áp dụng chương trình khuyến mại giá để đánh giá độ co giãn trước khi được bảo hiểm chi trả rộng rãi.

Lộ trình thanh toán bảo hiểm: Sau khả năng được FDA phê duyệt, GRAIL dự kiến sẽ đề nghị CMS bắt đầu quy trình phân tích phạm vi chi trả toàn quốc và tăng cường tiếp cận với các bên chi trả thương mại. Ban lãnh đạo lưu ý rằng một số chương trình khu vực và Medicare Advantage được chọn, bao gồm Priority Health, SIHO và Alignment, hiện đã chi trả cho Galleri.

Khác biệt hóa thương mại: Ban lãnh đạo tin rằng việc được FDA phê duyệt sẽ mang lại cho các bác sĩ cơ sở rõ ràng hơn để lựa chọn Galleri thay vì các xét nghiệm MCED khác do phòng xét nghiệm tự phát triển. Công ty dự kiến sẽ tăng cường đầu tư vào thương hiệu, bán hàng và tiếp thị cạnh tranh sau khi được phê duyệt.

Mở rộng quốc tế: GRAIL đã nộp hồ sơ xin phê duyệt IVDR tại châu Âu cho Galleri và tiếp tục duy trì thảo luận với NHS. Các cuộc thảo luận về thương mại hóa với Samsung tại Hàn Quốc cũng đang được tiến hành sau đợt huy động vốn 110 triệu USD hoàn tất trong quý 2/2026.

Toàn văn cuộc gọi công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good day, ladies and gentlemen, and welcome to the GRAIL Third Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that this conference call is being recorded.

GRAIL Investor Relations, please begin.

Unknown Executive

Thank you, and thank you all for joining us today. On the call are Josh Ofman, our Chief Executive Officer; Aaron Freidin, Chief Financial Officer; Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs; and Andy Partridge, Chief Growth Officer.

I'll remind you that we'll be making forward-looking statements based on current expectations. It's our intent that all statements other than statements of historical facts, including statements regarding our anticipated financial results and commercial activity will be covered by the safe harbor provisions for forward-looking statements under the federal securities laws.

Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the document that GRAIL files with the Securities and Exchange Commission, including the Risk Factors section in GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q we plan to file for the third quarter of 2026.

This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit, adjusted gross margin and adjusted EBITDA, which exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of GRAIL's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is available on our website.

With that, we turn to Josh.

Joshua Ofman

Thank you. Good afternoon, everyone, and thank you for joining us to review results for the third quarter of 2026 and to discuss recent business updates. GRAIL achieved multiple significant milestones this quarter, including a favorable vote for approval from the FDA's Advisory Committee and the publication of NHS-Galleri and PATHFINDER-2 results in the New England Journal of Medicine and Nature Medicine.

These important clinical and regulatory milestones position us very well as we continue to progress towards future potential regulatory approval and reimbursement. As you know, we submitted our premarket approval application for Galleri to the FDA in January of this year. And on September 23, the FDA convened an expert advisory committee to consider the safety, effectiveness and overall benefit risk profile of Galleri for screening for the early detection of multiple types of cancer in adults aged 50 years and older.

Galleri is the first multi-cancer early detection test to undergo FDA review through the PMA pathway, and we were very pleased with the positive vote. The advisory committee discussion highlighted the high evidence bar that GRAIL has set for the entire field of multi-cancer detection tests. We are engaged in interactive communications with the FDA since the advisory committee, and we expect to receive a final decision by early Q1 of 2027.

Galleri is supported by a broad evidence base, demonstrating its ability to detect cancer signals across over 140 cancer types and subtypes with a very low false positive rate and accurately identify cancer signal origin for those positive signals to support an efficient and directed workout. Based on what has now been demonstrated, we believe that adding Galleri to recommended single cancer screens can dramatically improve the effectiveness and the efficiency of national screening programs around the globe. This is best exemplified by a clear finding from the NHS-Galleri randomized controlled trial. When Galleri was added to standard of care, more than 4x more cancers were identified overall and Galleri found more Stage I and II cancers than the entire U.K.'s national screening program found all cancers across all stages.

Now this is remarkable and gives confidence that we can help improve how we screen for cancer and find cancers early before symptoms when there are opportunities for cure. We're very proud of our clinical evidence base, which we believe speaks for itself. And we continue to present and publish our studies in world-leading forums.

In September, results from our 2 largest prospective studies, NHS-Galleri and PATHFINDER-2 were published in the New England Journal of Medicine and Nature Medicine. These publications build on the results we presented at ASCO earlier this year and demonstrate the many clinically meaningful benefits of Galleri. Across these studies, Galleri has detected over 140 distinct types and subtypes of cancer. We believe the results of the NHS-Galleri trial demonstrated compelling clinical utility. Though we did not observe a combined reduction in Stage III and IV cancers, Galleri demonstrated the ability to generate a stage shift in cancer detection, producing a clinically meaningful reduction in Stage IV diagnosis.

This is a historic achievement. Performance metrics such as PPV and safety in both the PATHFINDER-2 and NHS-Galleri study were strong and consistent across populations and studies. Together, these studies demonstrate the consistency of Galleri's performance across 2 very large screening populations and 2 unique health care systems. We believe the results provide strong evidence that adding Galleri to standard of care screening can substantially increase the number of cancers identified through screening while maintaining a favorable safety profile.

The clinical utility metric of overall cancer detection is compelling, a 4- to 6.5-fold increase in cancer detection through screening, almost half of which are early Stage I and II cancers. And a 20% reduction in the incidence of Stage IV disease in a prespecified group of 12 deadly cancers, a 25% reduction in the emergency room diagnosis of cancer and of Galleri detected cancers at Stage I through III, more than 80% were treated with curative intent.

As we await an FDA decision, we are focused on making investments that help us to clearly differentiate Galleri and reduce much of the noise and confusion that exists in the marketplace. And we are also preparing for engagement with commercial payers and CMS.

Turning to commercial performance. In 2026, we continue to gain traction and see encouraging levels of volume growth. Test volumes increased 24% in Q3 as compared to the prior year. And to date, we have completed more than 174,000 tests in the first 3 quarters of the year, an increase of 36% from the prior year. In June, we expanded our provider sales force, and we continue to ramp new personnel for full productivity as we come out of the summer slowdown.

We are also expanding across -- excuse me, we're expanding access across provider, health system employer and digital channels through new and existing partnerships. We rolled out our first Epic integration at the end of Q3, and we expect several more integrations through the end of the year.

Now Q3 has typically been a relatively slow quarter, and the effect was compounded this year by the impact in the marketplace related to negative headlines about the NHS-Galleri results, which continued during and after ASCO. Combined with a very active competitive marketplace, this tempered growth in Q3. We expect a potential FDA approval would enable us to clarify the strength of Galleri's safety and performance data and reinforce that Galleri is the only FDA-approved MCED test, helping to create a bifurcated market with clear differentiation of Galleri. After potential FDA approval, Galleri will stand in the category all on its own.

Right now, there is confusion in the marketplace about which MCEDs may be FDA approved. At this time, all MCEDs are lab-developed tests, but there is a perception that these tests are similar, but of course, they are far from the same. Comparing test performance from small case-controlled studies to large interventional studies in the screening population is simply not scientifically appropriate, and we believe that it is important for the benefits and harms to be understood through interventional studies in the screening population.

On the heels of a positive FDA advisory committee and in anticipation of a potential FDA approval, we have started pulling forward our commercial investment, including the sales force expansion, launching our price promotion early and increased investing in direct-to-consumer advertising. We expect to further increase investment in brand awareness and competitive differentiation going forward as we reshape the market. If we obtain FDA approval, we will clearly differentiate Galleri as a robust, well-validated FDA-approved test.

Overall, GRAIL has had a very busy quarter. We achieved an important regulatory milestone with the favorable FDA advisory committee vote. We strengthened Galleri's evidence base through publication of our 2 landmark clinical studies and we continue to drive commercial penetration and build the foundation for broad market access. We are well positioned for continued growth as the clear leader in the MCED field, and we are looking forward to a near-term FDA decision.

We are preparing to drive growth acceleration if we receive approval. We believe this milestone will help support advancing engagements with health systems, self-insured employers, payers and guideline developers as well as supporting greater conviction among providers and consumers.

I'll now hand it over to Aaron for a review of our third quarter financials.

Aaron Freidin

Thanks, Josh, and good afternoon, everyone. In Q3, we reported revenue of $37.5 million, up $1.3 million or 4% as compared to the third quarter of 2025. Total revenue for the third quarter consisted of $37.3 million of screening revenue and $0.2 million of development services revenue.

Screening revenue was up 14% as compared with the third quarter of 2025 with test volumes of more than 56,000, an increase of 24% over the third quarter of 2025. Test volumes were moderately lower in Q3 compared to Q2, which is consistent with the seasonality pattern we have observed in Galleri sales since launch, with quarters 1 and 3 being relatively soft compared to quarters 2 and 4, and additionally reflects the headwinds we've seen in this market.

Overall, Galleri test volume grew 36% over the first 9 months of 2026 compared with the same period of the prior year. In parallel, ASPs have come down, resulting in a 24% growth in revenue over the first 9 months compared to the year prior.

In preparation for an FDA decision and in response to softer growth in the first 2 months of the quarter, we initiated a pricing promotion in September. We know that price is a significant barrier in the self-pay market, and we expect, as we have seen in the past, that the promotional pricing will generate additional demand.

As a result of pricing promotion, our Q3 ASP has come down to approximately $660 a test. We are intentionally prioritizing growth and market penetration over margin optimization in the short-term to drive market momentum as we approach an FDA decision and other meaningful milestones. We believe expanding volume grows the experience of providers and patients, provides more opportunity for repeat testing and drives down COGS over time. We have long expected that price levels will come down over time to support broad scale adoption as the MCED legislation ties the price to Cologuard. And the current pricing promotion will provide us with important data to set pricing strategy for the interim period before broad reimbursement.

As a reminder, the legacy Illumina royalty, which has been suspended, will resume in late December 2026. In 2026, we have been including in our quarterly filings, the calculation for the royalty that would have been paid had it not been suspended. For example, in Q3, we would have paid $2.6 million. In the first quarter of 2027, gross margin will be fully impacted by this royalty for the first time since we spun out as a public company.

However, as you know, our highly automated lab, our gross margins will improve as volumes grow. We continue to expect adjusted gross margins in the 50% to 60% range, including the Illumina royalty at scale. From where we are today, we see approximately $100 decrease in COGS due to scale as we approach our COGS of about $230, including the royalty. Beyond reductions associated with scale, we have further plans to bring down costs and increase margins, which we look forward to sharing in the future.

Continuing with key results for the quarter. Net loss for the third quarter was $103.6 million, an increase of 16% as compared to the third quarter of 2025.

Non-GAAP adjusted gross profit for the third quarter was $15.9 million, a decrease of $4.1 million or 20% as compared to the third quarter of 2025.

Adjusted gross margin of 42% and 46% for the 3 and 9 months ending September 30, 2026, were down from 55% and 49% for the 3 and 9 months ending September 30, 2025. As compared to Q3 2026 -- sorry, excuse me, comparing Q3 2026 to Q3 2025, the decrease in adjusted gross profit and gross margin was primarily driven by higher allocated overhead costs due to changes in sample mix, a reduction in development services and a reduction in ASP.

Adjusted EBITDA for the third quarter was negative $92.6 million, an increase in adjusted EBITDA loss of $20.9 million or 29% as compared to the third quarter of 2025. While we are tracking towards achieving our volume growth goals, this volume is coming at a lower ASP. As we look towards the end of the year, we are updating our guidance for the full year Galleri sales revenue growth to be 17% to 21%.

We believe that our promotional pricing in late 2026 will set the stage to enable faster growth in 2027 and beyond. Cash burn guidance of no more than $300 million for 2026 remains unchanged.

We ended the quarter with a cash position of $788.7 million. Our cash balance today provides runway into 2029 with financial flexibility as we advance key priorities, including our efforts to obtain regulatory approval and reimbursement for Galleri in the United States.

Back to you, Josh.

Joshua Ofman

Thank you, Aaron. Before we open the line for questions, I want to leave you with how we're thinking about the months and years ahead. Our primary focus is on preparing for a world where we achieve regulatory approval and broad reimbursement. This is our strategy to win in the long-term, where we look forward to broad population-wide annual screening with Galleri in addition to recommended single cancer screening tests. We are confident this paradigm can make a dramatic improvement in population health as cancer is the leading killer of adults over the age of 50.

In the near-term, we're focused on 3 key priorities. Continuing to interact with the FDA as they evaluate our PMA application, building the foundation for reimbursement, including continuing to further expand our extensive evidence base and turning the momentum we're seeing in the market into durable repeat demand as we create a bifurcated MCED marketplace.

The positive FDA advisory committee vote and the publication of NHS-Galleri and PATHFINDER-2 have earned us the strongest position we have ever had. We are being intentional with our investments in the field and providing a lower promotional price to drive scale and prepare for broad market access. We believe this is the right trade-off for patients and for long-term shareholder value.

Galleri is at the beginning of its growth curve, and we've made long-term investments that will enable us to continue to evolve and maintain clear leadership in the multi-cancer early detection field. We believe we stand alone in the rigor and extent of our clinical data and our test performance. And while the marketplace is becoming increasingly crowded with tests that to have various performance metrics and results, only Galleri has published and presented data showing strong and consistent performance in the actual screening population, our intended use.

We are continuing to invest to capture a long-term market where regular annual testing is available and reimbursed. We believe we have identified the strongest biological signal for cancer detection, we have built the most robust data package with strong regulatory and payer engagement and are well-positioned to progress into clinical guidelines.

There are more milestones to come, and we're tremendously proud of the progress we've made and our leadership in the field. Multi-cancer early detection has the potential to truly transform the patient experience and reduce metastatic disease across multiple cancers. No other intervention has demonstrated this at population scale.

Based on these latest data readouts, I can now envision a future where we can eradicate the diagnosis of metastatic cancer in our lifetime. None of this would be possible without the participants in our clinical studies, the clinicians and health systems who have put Galleri into practice and the GRAIL team whose work over the past 10 years to get us here has simply been extraordinary.

On behalf of all of us, thank you, and thank you to our shareholders for your continued support as we work to make early cancer detection part of routine care.

With that, operator, let's open the line for questions.

Operator

[Operator Instructions] Our first question will come from Subbu Nambi with Guggenheim.

Phần hỏi đáp

Subhalaxmi Nambi

I have an AdCom related question. At the AdCom, several panelists favor requiring documented shared decision-making and some raised concerns specifically about digital health platforms. If the final label does require you to have active consent or documented shared decision-making, how would that affect ordering to Hims function or your own telehealth? Have you had any FDA follow-up questions that touched on this?

Joshua Ofman

Subbu, thank you for the question. We actually have not had follow-up FDA questions about that. I think shared decision-making remains something that's very central to clinical care in all aspects and something people expect to happen at all times between the patient and their provider. But no, it's not been raised in our FDA discussions thus far.

Subhalaxmi Nambi

And I know you said related follow-up, but an unrelated follow-up. What are your updated thoughts on pricing and price elasticity for Galleri? Where do you expect to exit 2026 in terms of ASPs? And what's the realistic starting point for 2027 ASPs as you're prioritizing more volume over ASP?

Joshua Ofman

Thank you, Subbu. Aaron, do you want to go ahead and take that?

Aaron Freidin

Yes, Subbu. Great question. So as we alluded to, we're leaning into the pricing elasticity, and we saw that this quarter. For '27, it's too early to say. We'll talk to you about what our ASPs and volume and all that stuff will look like next year. For the rest of the year, as we said, we really launched into this in September, so in the last month of the quarter. And we're on a good track and expect our ASPs to be kind of in line for the year where we are right now.

Operator

Our next question will come from Dan Brennan with TD Cowen.

Daniel Brennan

Maybe just first one just on FDA. You mentioned early '27. So is that, I assume that's January, but did FDA give a date? Any color on that? And then you mentioned you've been in active discussion with FDA. Anything you can share about how the discussion has gone in terms of -- is the base case similar to the AdCom that it would be kind of an all-comers label and maybe there'd be some language on screen cancer. So anything you could share about what your base case is, how the discussion is going?

Joshua Ofman

Sure. Thank you for the question. Harpal, do you want to...

Harpal Kumar

Dan, Harpal here. So I mean, first of all, to say that continued discussions with the FDA, they're very active conversations. Interactions continue to be very positive. We are in very active label negotiations. And yes, look, we're saying early Q1. I'm not going to be more specific than that. We do not have a specific date from the FDA in answer to your question.

In terms of the actual label negotiations, we anticipate that the intended use will align with the data that we put forward to support the application and that will support the broad unmet need for additional cancer screening. And as we've said to you before, we anticipate being able to report results for any cancer type we detect.

Daniel Brennan

Great. And then just in terms of the volume and the competitive landscape, it looks like 4Q, maybe you're thinking somewhere like 20% volume growth, it appears. But I'm just wondering, have you seen any near-term benefit post the AdCom? And in terms of the ability to turn the tide with FDA approval, just -- yes, just help us think about your ability to distinguish between all the other tests out there with FDA. Is there any hesitancy that you won't be able to dramatically distinguish even with the approval given, as you mentioned, the competitive noise factor is pretty high.

Joshua Ofman

Thanks, Dan. Andy, do you want to take that?

Andrew Partridge

Thanks, Dan. We saw a lot of excitement from our prescribers following the advisory committee. When we actually look at the clinic and health system channel, which, as you know, is our largest business, we actually achieved our volume goals that we set in Q3. And we definitely got a tailwind from the advisory committee combined with the pricing promotion that we executed that drove a lot of new healthcare provider activation. We saw a lot of reactivation of dormant prescribers, and we've continued to make progress with health systems as well.

In market research that we've done with providers, we believe we can differentiate Galleri from the other MCEDs and when we add an FDA approval into that mix, we are confident we can differentiate our products and achieve that market bifurcation that Josh has described.

Operator

Our next question will come from Kyle Mikson with Canaccord Genuity.

Kyle Mikson

So maybe just continuing on Dan's train of thought there. The fourth quarter that hopefully will benefit from the AdCom. Third quarter, you talked about how there was some negative sentiment left over from ASCO. I guess there was other things you got the Epic maybe tailwind as well. So maybe just talk about anything you're seeing on those fronts in terms of the Epic or any other partnerships? And then it just feels like maybe we have to wait until this FDA approval in late 1Q for like an inflection volume. Maybe just speak to if that's a good way to think about this logically.

Joshua Ofman

Yes. Thank you, Kyle. I'll just -- I'll comment on that. There is some good momentum now coming out of the AdCom and in anticipation of a potential FDA approval. I'll ask Andy to comment on how he sees that momentum playing forward.

Andrew Partridge

Yes, Kyle, you asked about Epic. We started our Epic integration now. So we've got our first health system up and running. On Epic, we've got a number of health systems that are lined up for the Epic integration, both through the end of this year and into next year. And as you know, that's going to enable Galleri to be incorporated into prescribing behavior that happens in health systems.

We've got everything lined up for our launch following FDA approval that is going to, as we talked about earlier, differentiate Galleri from other MCEDs. It's going to drive additional health system adoption, we believe, potentially open up guideline discussions and an FDA approval, as we communicated previously, is going to enable us to really start more active engagement with payers going forward in our pursuit, ultimately a broad reimbursement.

Joshua Ofman

Kyle, just to mention, Kyle, to your point, the approval also provides physicians with a really easy to understand and easy to defend reason to choose Galleri. So it really helps the differentiation and creates a class of product Galleri will stand on its own relative to all the other MCEDs in the market that have scanned data and are in their very early development or experimental phases.

Kyle Mikson

Okay. Excellent. And maybe with -- as we get nearer the FDA approval, does that sort of light a fire under like CMS to create this policy for an NCD over time? And maybe similarly, there were some media sources indicating that HHS was pushing for USPSTF to include MCED. Maybe just -- can you just comment on any discussions with USPSTF, especially in light of the mid-terms?

Joshua Ofman

Sure. Kyle, this is Josh. We can't comment on any discussions with USPSTF. There's a lot of questions still about how that's going to take form or take shape. As it relates to CMS, after the FDA approval, we plan on engaging -- as we've already engaged CMS, we plan on engaging them to open a national -- their national coverage analysis. So we have to await the FDA approval to begin that. But we have been engaging with CMS around our data and around the REACH study all along the way.

Operator

Our next question will come from Doug Schenkel with UBS.

Angela Runyararo Kumirai

This is Angela on for Doug. My question is on CE Mark and NHS. How are you thinking about the potential timing for CE Mark in Europe if you are pursuing that? And specifically for the U.K., how should we think about the path and potential timing to NHS reimbursement following regulatory clearance?

Harpal Kumar

Yes. Thank you, Angela, for the question, Harpal here. So a couple of different points. So first of all, with respect to the U.K., we already have regulatory approval. The U.K. has a slightly different system now called the UKCA mark, which we already have. So we don't need to wait for regulatory approval in the U.K. As far as the rest of Europe is concerned, we have submitted for IVDR approval. That process is underway. It typically takes anywhere sort of around 12 months. So we're hoping for a readout sometime in 2027, but that process is well underway.

With respect to the NHS, we are continuing to have ongoing conversations. These will be matters that will be affected by overall budget considerations for the NHS as well as sort of the political environment, if you like. But we are in active discussions with the NHS, and we will continue to progress those, but I can't give you any sense of timing at this point.

Angela Runyararo Kumirai

Okay. And speaking on international, how is the Samsung financing arrangement progressing this quarter? And what commercial activities have you undertaken in those markets to date? That's Korea and Japan.

Aaron Freidin

Yes. I can start on the financing. So we closed $110 million round with them in Q2 of '26. And that part of the relationship is over. From a commercial perspective, I'm going to hand it over to Andy to say where we're at with them.

Andrew Partridge

Yes. We've started discussions with Samsung regarding commercialization in Korea, and those discussions are ongoing, and we'll update you further time points as they progress.

Operator

Our next question Dave Westenberg with Piper Sandler.

Karan Patel

This is Karan Patel on for Dave Westenberg. A couple of questions here. I guess maybe going back to the FDA and possible label restriction. I guess, can you provide any sort of color or guidance into thoughts on an upper bound age restriction? And what share of volume comes from the 65 and above cohort and then the 50 to 65 band as well?

Harpal Kumar

Yes. Harpal here. Thank you. I can't comment on detailed label negotiations with the FDA at this stage. We are still progressing discussions in line with the data that we submitted to the FDA, which is looking at populations of 50 and above. And so that's our consideration at the moment. In terms of the split between 50 to 65 and 65 and above, I mean, I think that should just reflect the overall population volumes rather than any specific label discussions.

Karan Patel

Understood. So maybe population level is reflective of current volumes. And then a follow-up question is, just anything on sales productivity. I think you guys' reps have kind of reached a steady point. Can you speak about full productivity, et cetera?

Joshua Ofman

Yes. Go ahead, Andy.

Andrew Partridge

Yes. I think as we kind of outlined previously, we did expand our sales force from 90 to 120 salespeople in June. That expansion obviously was complete. We're anticipating continued productivity from the team through the end of the year. And as I said previously, we actually met our volume goals in that channel where we expanded the sales team given that team is focused on our clinic business, where we've seen strong new prescriber growth, strong reactivation of dormant prescribers and strong repeat testing behavior from physicians as well.

Operator

Our next question will come from Robert Bamberger with Baird.

Joshua Montpas

This is Josh on for Robbie. Maybe first on competition. We've seen several peers out with additional advertising campaigns in recent months. Just wondering if you could walk through how you think about competitive profile here following positive AdCom results. How should we think about sales and marketing growth for 4Q and then also heading into 2027?

Joshua Ofman

Yes, happy to. We're -- as we've talked about, we're investing now given the positive AdCom, and we'll see that be in line with our plan for the rest of the year. For 2027, we're not done with that plan yet. We'll give more guidance later. But I'd expect us to be continuing to take advantage of the FDA approval when we get it.

Aaron Freidin

I think we'll continue to invest in our commercial marketing and our competitive messaging. And I think the FDA approval, if we should receive it, is going to be quite helpful in helping us continue to differentiate. And I think the tactics that we've been deploying in the market now, we're just going to continue to accelerate once we do get the approval.

Joshua Montpas

Great. And I think this is the first full quarter that you had the sales force sending out the message on full NHS-Galleri and PATHFINDER-2 results. Just what has feedback been from existing ordering physicians since that's been out there? And how effective has your team been getting your message to resonate with providers, just given some of the noise that you mentioned earlier in the call?

Andrew Partridge

Yes. Thanks for the question. The NHS-Galleri and PATHFINDER-2 results are highly differentiating. Galleri is the only product that has been proven to reduce Stage IV. That is a highly compelling message when we deliver that to physicians and having the full publications now in New England Journal of Medicine and Nature Medicine on top of the Advisory Committee and now the pricing promotion has really generated a lot of excitement in the clinic and health system channels, which was a key driver of why we were able to meet our volume goals for Q3 for that channel, which, as you know, is the largest channel for Galleri.

Operator

Our last question will come from Brad Bowers with Mizuho.

Bradley Bowers

Yes. So I wanted to hear, we have some analogs now on volume trajectory of screening tests. You alluded to this a bit in the prepared remarks, but FDA is a nice kick, but then reimbursement is even more so and then guidelines. It seems like you kind of share this view, but just wanted to get into how we should, I guess, think about medium-term modeling and kind of the step-ups associated with that.

Aaron Freidin

Yes. It's Aaron. I'll take a shot at it. I think as Andy alluded to, we're going to be trying to -- with the FDA approval, we'll be going out to establish a differentiated product to put ourselves separate and so on from the rest of the competition. Which I think will help us be in a better position against the market.

As far as modeling that growth with an FDA-approved product that's still in a self-pay market, I think that's a little bit more challenging. And as I said, as we get to 2027 guidance, we'll give you more detail there. But I feel comfortable saying comparatively, FDA approval alone versus a reimbursement or a guideline is going to be a lower inflection point. Obviously, I'm sure you'd agree. I don't know, Josh, anything else you want to add.

Joshua Ofman

No, I would just say that what the FDA approval really provides is the gateway now for coverage and reimbursement. And we are going to be dramatically accelerating our engagement with payers and CMS going forward. And now with an FDA-approved product, we have an opportunity. Remember, Medicare with legislation that was passed this year can provide coverage for MCEDs that are FDA approved only. And so that provides us uniquely that opportunity, which we're going to be pursuing very rigorously going forward. And obviously, we're going to be very active in engaging commercial payers now from this point forward going on. And the FDA approval has always been the major gateway for that. Andy, other things you want to add?

Andrew Partridge

I think you really covered it, Josh, as you know, we've built a team that is actively engaging with payers today. We've already had some success with payers. Select regional plans like Priority Health and SIHO. Also Medicare Advantage plans like Alignment and Priority Health have already provided coverage for Galleri. And as Josh said, the FDA approval now is going to open up these conversations, not just with regional payers, but also national payers, covering both self-insured employers with ASO plans and Medicare Advantage plans going forward, and we're going to intensify those payer engagement efforts on the back of a potential FDA approval.

Bradley Bowers

That's awesome color. I appreciate that. While we're on the commercial payer conversation, obviously, you guys are smart with your pricing, having been out in the market for self-pay and with the pricing promotions bearing fruit this quarter. How do you think -- are you going to be able to take that data to the payers? Obviously, patients want lower out-of-pocket cost. The payers will try to figure out where to -- I guess, how to optimize volume and price, but obviously, want to make sure you guys are getting appropriately paid for the results that you're providing. How are all those things being considered?

Andrew Partridge

Yes. It's part of our plan. That payer team that we've built that are now engaging with payers also work in tandem with our employer team that call on benefits managers for self-insured employers. They've got a whole value proposition and value dossier for Galleri that includes budget impact models that they're having conversations with these payers and self-insured employers, all with the goal of expanding coverage and covered lives given ASO plans for self-insured employers and Medicare Advantage plans are going to be part of our focus going forward, assuming the potential FDA approval that we're in discussions with the agency with right now.

Joshua Ofman

It's still early days, too early to comment on things like cost sharing requirements or co-pays. But as we dig deeper and engage more thoroughly with all of these regional and national payers, we'll have more to say about that in the future.

Operator

There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect.