Cuộc họp báo cáo kết quả kinh doanh Quý 3 năm 2026 của Krystal Biotech (KRYS): Doanh thu VYJUVEK tăng 30%

Thông tin trọng tâm

• Krystal Biotech đã báo cáo doanh thu thuần VYJUVEK quý 3 năm 2026 đạt 127,3 triệu USD, tăng 30% so với cùng kỳ năm ngoái, bao gồm 95,3 triệu USD từ thị trường Mỹ và 32,0 triệu USD từ thị trường quốc tế.
• Lợi nhuận thuần đạt 63,1 triệu USD, với EPS pha loãng là 2,05 USD. Biên lợi nhuận gộp giảm xuống 94% từ mức 96%, một phần do châu Âu và Nhật Bản vẫn chưa hưởng lợi từ các tối ưu hóa quy trình sản xuất đã được chấp thuận tại Mỹ.
• Công ty đã kết thúc tháng 9 với hơn 1,2 tỷ USD tiền mặt và các khoản đầu tư. Hội đồng quản trị đã phê duyệt tối đa 400 triệu USD để mua lại cổ phiếu, dự kiến sẽ được triển khai trong hai năm.
• Động lực thương mại tại Mỹ bao gồm hơn 760 phê duyệt hoàn trả chi phí và hơn 80 bác sĩ kê đơn mới trong quý. Khoảng 80% bệnh nhân hiện tự sử dụng VYJUVEK.
• Ban lãnh đạo đã hạ dự báo chi phí R&D và SG&A phi GAAP cả năm xuống 155 triệu - 165 triệu USD, từ mức 175 triệu - 195 triệu USD.
• Một số mốc thời gian thử nghiệm lâm sàng đã thay đổi. Kết quả thử nghiệm KB803 cho bệnh DEB ở mắt dự kiến sẽ có ngay sau lượt thăm khám bệnh nhân cuối cùng vào tháng 2 năm 2027, trong khi việc tuyển bệnh nhân và kết quả sơ bộ của KB801 cho bệnh viêm loét giác mạc do thần kinh hiện dự kiến vào năm 2027.

Kết quả tài chính cốt lõi

Krystal cho biết doanh thu lũy kế của VYJUVEK kể từ khi ra mắt đã đạt khoảng 1,1 tỷ USD.

Kết quả hoạt động kinh doanh

Tăng trưởng của VYJUVEK tại Mỹ

Krystal đã nhận được hơn 760 phê duyệt hoàn trả chi phí trên toàn quốc và có thêm hơn 80 bác sĩ kê đơn trong quý 3. Ban lãnh đạo nhận thấy cơ hội mở rộng hơn nữa ở những bệnh nhân đã được chẩn đoán nhưng chưa bắt đầu điều trị, cũng như những người chưa được chẩn đoán hoặc bị chẩn đoán sai.

Việc điều trị tại nhà cũng đang trở nên phổ biến hơn, với khoảng 80% bệnh nhân hiện tự sử dụng VYJUVEK. Công ty đang tập trung vào việc mở rộng số lượng bệnh nhân bắt đầu điều trị, đồng thời hỗ trợ việc sử dụng liên tục khi nhu cầu chăm sóc vết thương của bệnh nhân thay đổi.

Mở rộng thị trường quốc tế

Doanh thu VYJUVEK quốc tế đạt 32 triệu USD. Đức hiện có hơn 20 trung tâm đã bắt đầu điều trị cho bệnh nhân, tăng khoảng 15% so với quý trước. Các cuộc đàm phán giá cả tại Đức đã hoàn tất.

Pháp đã hoàn thành lượt tự sử dụng thuốc tại nhà đầu tiên thông qua cơ chế hoàn trả trực tiếp (retrocession pathway). Các cuộc đàm phán giá ở cấp quốc gia vẫn đang diễn ra, với ban lãnh đạo lưu ý rằng quy trình này đang đi đúng lộ trình thông thường.

Tại Nhật Bản, Krystal tiếp tục ghi nhận thêm bệnh nhân và bác sĩ kê đơn. Ban lãnh đạo kỳ vọng việc nới lỏng các hạn chế kê đơn trong năm đầu tiên sẽ thúc đẩy tốc độ tiếp nhận nhanh hơn.

Các cuộc đàm phán về giá và hoàn trả chi phí tại Ý đã hoàn tất, và công ty dự kiến ra mắt VYJUVEK tại đây vào đầu năm 2027. Quyết định về giá tại Tây Ban Nha dự kiến sẽ có trước cuối năm 2026, trong khi một số bệnh nhân đã được điều trị thông qua các thỏa thuận tài trợ đặc biệt của vùng.

Tiến độ phát triển sản phẩm

Kết quả ban đầu của KB113 ở ba người trưởng thành mắc hội chứng Gorlin cho thấy có phản ứng ở cả các khối ung thư tế bào đáy được tiêm và không được tiêm. Hơn một nửa số tổn thương được đánh giá đã thuyên giảm hơn 50%, trong khi khoảng 10% khối u thu nhỏ ít nhất 90%. Đánh giá mô bệnh học đã xác nhận sự thoái triển hoàn toàn ở một khối u được tiêm đã sinh thiết từ mỗi bệnh nhân. Krystal đang thảo luận về các định hướng phát triển tiềm năng với FDA.

Đối với KB111 trong điều trị bệnh Hailey-Hailey, năm bệnh nhân đã hoàn thành việc đăng ký tham gia nghiên cứu liều lặp lại HALITE-1. Ban lãnh đạo dự kiến sẽ cập nhật dữ liệu trước cuối năm 2026, sau đó là các cuộc thảo luận với FDA.

Về bệnh DEB ở mắt, Krystal đã tuyển thêm ba bệnh nhân dùng KB803, bao gồm việc thay thế cho hai trường hợp rút khỏi thử nghiệm không liên quan đến độ an toàn và một trẻ em một tuổi. Lượt thăm khám bệnh nhân cuối cùng dự kiến diễn ra vào tháng 2 năm 2027, và kết quả sơ bộ sẽ có ngay sau đó.

Việc sử dụng liều lặp lại KB407 đang được tiến hành trên ba bệnh nhân xơ nang, với ba bệnh nhân bổ sung dự kiến sẽ được tuyển chọn và dùng thuốc trước cuối năm. Kết quả giữa kỳ, bao gồm dữ liệu FEV1, dự kiến sẽ có trong nửa đầu năm 2027. Công ty cũng đang trao đổi với FDA về thiết kế nghiên cứu tiềm năng để đăng ký cấp phép.

Đối với KB707 dạng hít trong điều trị ung thư phổi không tế bào nhỏ tiến triển, Krystal đã hoàn thành việc tối ưu hóa liều lượng trên 10 bệnh nhân. Công ty dự kiến sẽ tuyển chọn và dùng thuốc cho 70 bệnh nhân theo phác đồ hóa trị đã chọn vào giữa năm 2027.

Dự báo của Ban lãnh đạo

• Dự báo chi phí R&D và SG&A phi GAAP cả năm đã được điều chỉnh thành 155 triệu - 165 triệu USD, giảm so với mức 175 triệu - 195 triệu USD.
• VYJUVEK dự kiến sẽ ra mắt tại Ý vào đầu năm 2027, tùy thuộc vào việc triển khai các kế hoạch tiếp cận thị trường.
• Quyết định về giá tại Tây Ban Nha dự kiến sẽ có trước cuối năm 2026.
• Dữ liệu về KB111 trong điều trị bệnh Hailey-Hailey dự kiến sẽ có trước cuối năm 2026.
• Kết quả sơ bộ thử nghiệm KB803 cho bệnh DEB ở mắt dự kiến sẽ có ngay sau lượt thăm khám bệnh nhân cuối cùng vào tháng 2 năm 2027.
• Việc hoàn thành tuyển chọn bệnh nhân và kết quả sơ bộ của KB801 điều trị viêm loét giác mạc do thần kinh dự kiến sẽ có vào năm 2027.
• Kết quả giữa kỳ của KB407 trong điều trị xơ nang dự kiến sẽ có trong nửa đầu năm 2027.
• Công ty dự kiến sẽ triển khai chương trình mua lại cổ phiếu trị giá 400 triệu USD đã được phê duyệt trong hai năm, trong khi tiếp tục tài trợ cho việc mở rộng thương mại và phát triển lâm sàng.

Rủi ro và các điểm cần theo dõi

Một số kết quả thử nghiệm lâm sàng đang mất nhiều thời gian hơn dự kiến ban đầu. Việc tuyển chọn bệnh nhân cho KB801 đã bị ảnh hưởng bởi tiêu chuẩn chọn bệnh nhân hẹp, tỷ lệ sàng lọc thất bại, sự chậm trễ trong ký kết hợp đồng tại các trung tâm nghiên cứu học thuật và sự cạnh tranh từ một liệu pháp đã được phê duyệt hiện có tại Mỹ.

Mốc thời gian của KB803 đã bị thay đổi sau khi hai bệnh nhân rút khỏi thử nghiệm do không muốn cam kết liều dùng hàng tuần. Ban lãnh đạo cho biết việc rút lui này không liên quan đến độ an toàn, nhưng các bệnh nhân vẫn sẽ được giữ lại trong nhóm phân tích theo ý định điều trị.

Việc tuyển chọn bệnh nhân cho KB407 đã bị trì hoãn sau khi các bệnh nhân tiềm năng bị ốm. Ban lãnh đạo nhấn mạnh rằng việc bổ sung người tham gia không xuất phát từ vấn đề liều lượng và cho biết các bệnh nhân hiện tại đang dung nạp tốt với việc dùng liều lặp lại.

Chính sách hoàn trả chi phí quốc tế vẫn chưa hoàn tất. Pháp vẫn đang đàm phán giá, và các quốc gia châu Âu khác vẫn cần phê duyệt tiếp cận thị trường. Biên lợi nhuận gộp cũng có thể bị ảnh hưởng trong khi châu Âu và Nhật Bản hoạt động mà chưa có các tối ưu hóa quy trình sản xuất đã được chấp thuận tại Mỹ.

Những điểm chính trong phần Hỏi & Đáp với Chuyên viên phân tích

• Phân bổ vốn: Ban lãnh đạo cho biết quyền phê duyệt mua lại cổ phiếu trị giá 400 triệu USD phản ánh sự tự tin rằng doanh thu từ VYJUVEK và số dư tiền mặt của công ty có thể hỗ trợ cả việc phát triển danh mục sản phẩm lẫn mang lại lợi nhuận cho cổ đông. Krystal vẫn sẵn sàng tăng cường đầu tư ở những nơi mà việc chi tiêu bổ sung có thể đẩy nhanh tốc độ tuyển bệnh nhân hoặc kích hoạt các trung tâm nghiên cứu.
• Tuyển chọn bệnh nhân cho KB801: Công ty dự kiến bổ sung thêm 10 đến 15 trung tâm tại Mỹ và kích hoạt các trung tâm trên khắp Pháp, Tây Ban Nha, Anh cùng các thị trường châu Âu khác. Krystal đang duy trì các tiêu chuẩn nghiêm ngặt về sự tồn tại dai dẳng của tổn thương để giảm rủi ro tuyển những bệnh nhân có tổn thương giác mạc tự cải thiện.
• Sẵn sàng nộp hồ sơ KB803: Ban lãnh đạo cho biết các yêu cầu về Quy trình Sản xuất và Kiểm soát Chất lượng (CMC) đã sẵn sàng và công ty dự kiến sẽ nộp Hồ sơ Xin cấp phép Báo chế Sinh học (BLA) ngay sau khi khóa cơ sở dữ liệu và phân tích, giả định kết quả khả quan.
• Phát triển điều trị hội chứng Gorlin: Dựa trên phản ứng ghi nhận trong nghiên cứu thí điểm trên ba bệnh nhân, ban lãnh đạo tin rằng một thử nghiệm then chốt tiềm năng có thể bao gồm ít hơn 100 bệnh nhân, tùy thuộc vào sự thống nhất với FDA.
• Trình tự công bố kết quả: Ban lãnh đạo xác nhận rằng kết quả thử nghiệm bệnh DEB ở mắt dự kiến sẽ có trước kết quả của KB801 cho bệnh viêm loét giác mạc do thần kinh.

Toàn văn Biên bản Cuộc họp Báo cáo Kết quả Kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, and thank you for standing by, and welcome to Krystal Biotech's Third Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Chief -- sorry, Senior Vice President of Corporate Development. Please begin.

Stephane Paquette

Good morning, and thank you all for joining today's call. Earlier today, we released our financial results for the third quarter of 2026. The press release is available on our website at www.krystalbio.com. We also filed our earnings 8-K and 10-Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Laurent Goux, Executive Vice President and General Manager for Europe; Christine Wilson, Senior Vice President and Head of U.S. Commercial; and Kate Romano, Chief Accounting Officer. This conference call will and our responses to questions may contain forward-looking statements.

You are cautioned not to rely on these forward-looking statements, which are based on current expectations using the information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties and other factors can be found in our SEC filings. With that, I'll turn the call over to Krish.

Krish Krishnan

Good morning, and thank you for joining us. Q3 was another strong Q for Krystal. We delivered $127.3 million in VYJUVEK revenue, an increase of 30% from the same period last year and reported diluted earnings of $2.05 a share and ended September with $1.2 billion in cash and investments. Those results, they reflect a business that's growing, that's profitable and generating the resources to advance our pipeline. They also reflect the work our teams have done to build Krystal into a global company with commercial operations, manufacturing capabilities, clinical development programs that we own and control. And to date, we have generated approximately $1.1 billion in VYJUVEK revenue since launch, and that is an important milestone for a medicine developed here at Krystal.

Behind that number are so many patients receiving treatment, physicians incorporating a new paradigm of genetic medicines into their practices and families getting access to a medicine that addresses the underlying cause of DEB. In the U.S., demand continues to grow as does the prescribing physician base. And internationally, we continue to translate physician interest into patient starts across Germany, France and Japan. The pricing secured by VYJUVEK in Japan and Germany and Italy to date reflects recognition of the meaningful benefits that VYJUVEK provides patients and families.

I'm proud of our team's thoughtful work to demonstrate that value and establish a strong foundation for patient access internationally. We'll continue to build on this progress in ensuing pricing discussions across additional markets, and Laurent will discuss those markets in more detail. We also made meaningful progress in development. We were really encouraged by the recent Gorlin Syndrome clinical results that demonstrated progression in both injected and non-injected lesions together with the histologically confirmed clearance of an injected lesion in each patient. So that gives us a very strong foundation to have conversations with the FDA on next steps. I want to address the updated timing of some of our clinical readouts. And while we had hoped to share these readouts sooner, I want to be clear that the programs continue to progress well, and we look forward to sharing results in the upcoming months. Suma will elaborate more in a few minutes.

Alongside these developments, our Board authorized a share repurchase program of up to $400 million that we expect to deploy over the next 2 years. We have reached a position where our financial resources allow us to support global commercial expansion, pipeline and clinical development and have the flexibility to return capital to shareholders. And the authorization reflects our confidence in Krystal's long-term prospects and our responsibility to allocate this capital thoughtfully. So taken all together, this Q demonstrated the strength of the business we've built. It demonstrated continued commercial growth, substantial profitability and progress across the pipeline. For that, I'd like to thank our employees, our investigators and the patients and families participating in our studies for helping make that progress possible. And with that, I'll turn it over to our team to walk through commercial, clinical and financial updates.

Laurent Goux

Thank you, Krish. VYJUVEK international revenue reached $32 million in the third quarter. We continue to translate physician interest into patient starts while strengthening the growth foundation through reimbursement progress and greater access to treatment at home. In Germany, pricing negotiations have concluded, providing greater visibility as we expand our reach across the country. More than 20 centers have now initiated patients on VYJUVEK, up circa 15% from last quarter. Doing so, we continue to broaden the treatment network to reach patients who are not routinely seen at established expert centers.

In France, we achieved an important milestone with the first home administration through the retrocession pathway. This creates an opportunity to reduce the practical burden of treatment on patients and families and support treatment continuity. We are now working to expand this approach to additional eligible patients and centers while national pricing discussions continue. And in Japan, our team is making steady progress, bringing new patients to treatment and expanding our prescriber network. We are also advancing support initiatives to help the EB community maximize the potential benefits of VYJUVEK therapy and navigate the complexity of VYJUVEK's GMO status.

Looking ahead, pricing and reimbursement negotiations in Italy have also concluded, and we now expect to launch VYJUVEK in early 2027. In Spain, pricing discussions are progressing with a decision expected before the end of the year. Some patients already have access through exceptional regional funding arrangements, providing a foundation for a potential launch next year. We are also advancing regulatory and market access activities in additional countries to expand VYJUVEK's reach over time. Taken together, these developments give us confidence in the international opportunity.

Health systems are recognizing VYJUVEK's value, physicians are gaining treatment experience and barriers to administration are beginning to come down. Our focus is on turning that progress into more patients starting and continuing treatment. With that, I'll hand the call over to Christine.

Christine Wilson

Thank you, Laurent. U.S. net revenue for the third quarter was $95.3 million, reflecting continued demand for VYJUVEK and our efforts to reach more patients. We have now secured more than 760 reimbursement approvals nationwide. During the quarter, we added over 80 new prescribers. This expanding physician base supports continued adoption, and we believe substantial opportunity remains among diagnosed patients who have not yet started treatment as well as those who remain undiagnosed or misdiagnosed. We are also seeing the benefits of greater treatment flexibility. Approximately 80% of patients now self-administer VYJUVEK, helping patients and caregivers incorporate treatment into their wound care routines at home.

As patients gain experience, our focus extends beyond treatment initiation to supporting continued use as their wound care needs evolve. Our VYJUVEK voices and VYJUVEK connection programs provide education, practical support and opportunities for patients and caregivers to learn from one another. Engagement with physicians, advocacy organizations and the broader DEB community also helps us understand barriers to treatment and improve the support we provide. Looking ahead, our priorities remain clear: reach more patients, expand the prescribing network and support long-term treatment. With continued demand, a growing physician base and greater flexibility in administration, we believe VYJUVEK is well positioned for sustained U.S. growth.

We are proud of the progress we have made and excited about the opportunities ahead as we continue working to establish VYJUVEK as the long-term standard of care for patients living with DEB. With that, I'll turn the call over to Suma.

Suma Krishnan

Thank you, Christine, and good morning, everyone. We have encouraging progress to share this morning, including our initial Gorlin syndrome results, the upcoming Hailey-Hailey readout and the ongoing dosing in cystic fibrosis. But before I get into the update, I want to acknowledge that some clinical results are going to take a bit longer than we initially expected. We recognize the importance of these milestones. Our teams are working diligently to advance each study, and we look forward to sharing the data as they become available. Importantly, the studies themselves are progressing well, and we remain encouraged by their eventual outcome. I'll walk through our rationale and expectations from here shortly.

With that, I would like to start today's update with the latest addition to our pipeline, KB-113 for Gorlin syndrome. Gorlin syndrome is a rare genetic disease estimated to affect more than 10,000 Americans. Patients can develop hundreds of basal cell carcinomas or BCCs over their lifetime, requiring repeated surgeries that can lead to tissue loss, disfigurement and significant psychological burden. With no therapy specifically approved for Gorlin syndrome, there is a substantial need for a safe, effective treatment to reduce BCC burden. KB707 is our HSV1-based immunotherapy designed to drive sustained localized expression of human IL-2 and IL-12 in the tumor microenvironment and promote systemic immune-mediated tumor clearance.

We recently completed a pilot study evaluating a low dose of intratumoral KD707 which we now refer to as KB113 in 3 adult patients with Gorlin syndrome. Each received 6 doses over 14 weeks. Investigators assess regression in both injected and non-injected landmark BCCs throughout treatment and 30 days after the final dose using a prespecified 5-point scale. Profound treatment benefits were observed following KB113 treatment, including broad antitumor responses in all 3 Gorlin syndrome patients. As summarized in the table on the left, over 80% of the assessed patients regressed over the course of the study and more than half of all lesions regressed by over 50%. Critically, substantial regression was observed in lesions that were never directly injected, providing preliminary evidence of systemic immune activation and an abscopal effect.

Investigators also reported that a meaningful proportion, roughly 10% of all assessed tumors had shrunk by at least 90%, indicating potential for tumor eradication with KB113 treatment. To further assess depth of response, 1 injected tumor from each patient was biopsied for histological assessment. In all 3 cases, complete clearance was confirmed with no evidence of residual tumor tissue in the biopsy. Images shown on the right highlight the rapid improvement achieved in Gorlin patients with KB113 and add to the body of evidence suggesting significant potential for KB113 to dramatically reduce PCC burden in patients with Gorlin syndrome. With the addition of KB113 to our pipeline, we are now building out a robust development effort in rare dermatology diseases, an area we know well and where we can move fast.

In the case of KB113, we have already started engaging with FDA regarding potential clinical development pathways in Gorlin syndrome. We will share an update on our plans once aligned with the FDA. We are also making good progress on our KB111 program for HHD. We have completed enrollment of 5 patients in our repeat dose study for HALITE-1 and expect to share a data update before year-end. We then expect to meet with the FDA to discuss next steps. Turning to our ophthalmology pipeline. I want to start by saying that both NK program and the ophthalmic VJUVEK programs are progressing well. In the case of KB803, we enrolled 3 additional patients in our registrational IOLITE study. Two of these additional patients have been enrolled to replace 2 patients who withdrew for reasons unrelated to safety. The third patient, a child 1 year of age, was enrolled to generate evidence to support potential treatment of corneal abrations in DEB patients from birth.

We now expect that the last patient last visit in February 2027 with top line results to be reported shortly thereafter. In KB801 for NK patients, enrollment has progressed more slowly than we initially anticipated, reflecting the study's narrowly defined eligibility criteria and the challenges of enrolling patients in a placebo-controlled trial in an indication with an available approved therapy. We are also working diligently to expand our clinical trial infrastructure. We have activated 22 sites in the United States, and we are close to activating sites in France, Spain and United Kingdom. With continued investment and expansion of our trial network, we now expect to complete the enrollment and report top line results in 2027.

In the lung, we are steadily advancing our program in CF and AATD. Starting with KB407 in CF, we are currently dosing 3 patients in our repeat dose study and expect to enroll and dose 3 additional patients before the year-end. Based on this enrollment timeline, we now anticipate interim study results in the first half of 2027. We are progressing in parallel our discussion with the FDA regarding a potential registrational study design, having recently been selected for FDA's Complex Innovative Design Meeting Program. This is enabling intensive FDA engagement and has us on track for a 27 registrational study start. We also continue to enroll in our KB408 repeat dose study and are on track to report interim data next year. The successful gene delivery already confirmed by biopsies for both KB407 and KB408, we believe we are uniquely positioned to fill urgent treatment gaps for CF and AATD patients. We look forward to sharing more in 2027.

Finally, we are making great progress on our inhaled KB707 program, enrolling patients with advanced NSCLC in the global KYANITE-1 expansion cohort evaluating inhaled KB707 plus chemotherapy. We have completed dose optimization in 10 patients to inform chemotherapy dose selection and expect to enroll and dose 70 patients at the selected regimen by mid-2027. Results from this cohort will help us finalize our plans for subsequent registrational study of KB707. Each disease that we are targeting with our pipeline is an urgent unmet need. We recognize the importance of progressing deliberately and quickly to fill these treatment gaps. With our expanded R&D infrastructure, I'm confident that we can deliver on our ambitions and dramatically grow our impact. With that, I'll hand the call over to Kate.

Kathryn Romano

Thank you, Suma. I'll now provide a few additional highlights from our third quarter financial results as reported in our press release and 10-Q filing earlier today. Net revenue from global sales of VYJUVEK was $127.3 million for the quarter, driven by the continued growth from our Europe and Japan launches and representing a 30% increase over the prior year's third quarter of $97.8 million, which included only a partial quarter of sales from Europe and excludes sales from Japan. Cost of goods sold for the quarter was $7.6 million compared to $4.3 million in the prior year's third quarter. Gross margin for the quarter was 94% as compared to 96% in the third quarter of 2025. The 2% decrease in gross margin was due in part to the increase in sales of products in Europe and Japan, which do not yet benefit from manufacturing process optimizations approved in the U.S. as well as the sale of lower cost R&D batches in the prior year quarter following FDA approval of the optimized process.

R&D expenses for the quarter were $14.9 million compared to the prior year of $14.6 million. G&A expenses were $33.7 million compared to $37.6 million in the prior year's third quarter. This $3.8 million decrease was primarily due to the receipt of insurance proceeds as reimbursement of legal costs previously incurred along with a reduction in period-over-period legal costs, professional service fees and marketing costs, offset by increased payroll costs. Operating expenses for the quarter included noncash stock-based compensation of $13.9 million compared to $13.2 million in the third quarter of last year. Net income for the quarter was $63.1 million, which represented $2.13 per basic and $2.05 per diluted share.

In the third quarter of 2025, net income was $79.4 million and EPS was $2.74 per basic and $2.66 per diluted share. In the third quarter of last year, we had released a majority of the valuation allowance that was historically recorded against our deferred tax assets, and we also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation. Both of these items were nonrecurring. Looking ahead to the remainder of the year, we are also revising our full year non-GAAP R&D and SG&A guidance to $155 million to $165 million from our prior guidance of $175 million to $195 -- and finally, we continue to build on our solid financial position, now exceeding $1.2 billion in overall cash and investments. With this foundation, we remain focused on disciplined capital allocation to support our pipeline and global commercial strategy while maintaining the ability to return capital to shareholders through our newly authorized share repurchase program. And now I'll turn the call back over to Krish.

Krish Krishnan

What excites me most is the opportunity we have to build a company whose impact extends well beyond its first medicine. And with each program, we can apply what we've learned, deepen our capabilities and pursue additional diseases where patients need better options. With pricing negotiations behind us in Japan, Germany and Italy, we can now more clearly see meaningful room for VYJUVEK growth internationally. We have a rich pipeline with several important readouts in the upcoming months. And as I said before, the initial Gorlin findings are very encouraging, and we look forward to the upcoming Hailey-Hailey results along with CF and NK. Each program will generate evidence that helps us determine how best to bring additional medicine to patients.

Financially, we've put ourselves in a good place. The growing commercial business allows us to invest not just in global expansion, but also in development and buy back shares opportunistically. And so we'll allocate capital with a clear focus on building lasting value per share. I'm confident in Krystal's future. We have a strong foundation. We have the resources to invest and a team that's super committed to turning scientific potential into meaningful medicines. -- and our responsibility is to translate all those strengths into more patients treated. So thank you to the employees, the patients, investigators and our shareholders for your continued support, and I'll open the call up for questions.

Operator

Thank you. [Operator Instructions] Our first question today is coming from Lachlan Hanbury-Brown with William Blair.

Phần hỏi đáp

Lachlan Hanbury-Brown

On all the progress. I guess first question maybe on KB407. You said you're enrolling an additional 3 patients. I was wondering on the rationale for that. I mean, are you going to test a different dose? Is there something that you've seen in the first few patients that makes you a larger sample here? And then on the second question, wondering about Japan. Krish, you've talked in the past about how the sort of first year restrictions can limit adoption. So as we kind of approach that 1-year mark, wondering how we should think about the sort of acceleration of growth in Japan moving forward?

Krish Krishnan

Thanks Lachan for the question, Suma?

Suma Krishnan

Yes, I can address the KB803, sorry, I can address the KB407 question, sorry, KB407. Yes, I mean, we have 3 patients right now. They're ongoing on the repeat dosing. It has nothing to do with the dose. I mean we are very excited. I mean these patients are tolerating repeat dose. That was one of the biggest questions we had to address the -- with regarding to safety. And obviously, we're collecting FEV1 data.

The enrollment for these additional 3 patients are going to happen this year. Unfortunately, it was a little slow because some of the patients that were supposed to get on the drug fell sick. And remember, these are patients that are novel and with no other options. So it is their life events that actually pushed out. But I think we feel confident all the patients will get on the study, and we expect to have this data by middle of next year.

Krish Krishnan

On the Japan question, I mean that's valid like that in the next, I think, upcoming -- I don't remember the timing, which should be November, December, the prescription kind of lifts off and it goes from maybe twice a month to once a month, and we definitely believe that, that would incentivize a faster adoption, especially in a country where people commute long distances to get to the physician office.

Operator

Our next question is coming from Ritu Baral with TD Cowen.

Ritu Baral

I wanted to keep my 2 questions to KB801 in NK. Can you talk a little bit about how much you're expanding sites beyond the 22 U.S. sites? Do you have a number of additional sites and how you expect that to impact potential study conduct? And also, can you talk to sort of like the exclusion criteria where that's driving most of the screen failures for enrollment of the study? And anything else you can give us on potential timing in 2027?

Suma Krishnan

Thank you. So I'll address this question. We are expanding additional sites in the U.S. We have another 10 to 15 sites. Unfortunately, the academic sites big ones that have the patients have been delayed because of contracts. And remember, this is a GMO and it's going to be home administered. So we ran into some glitches with them, but we are overcoming all these sites. So we expect many of these academic sites with a large number of patient pools to come online very shortly. I think we have overcome the bump.

So we continue to expand the U.S. pool, but we are going to go beyond U.S. because there are -- Oxervate is available to these patients. As you know, Oxervate has been aggressively marketed in the U.S. So I think we have an opportunity in the EU where Oxervate is not available. We are -- we have talked to sites. They have a lot of patients. We are in the process of actually activating all of the sites. So we are not -- I mean, we are going pretty aggressively and getting multiple sites across the EU region and even Eastern Europe to get -- to actually really improve our enrollment. So I think with what we are seeing, I'm hopeful that enrollment will pick up.

But to your second point also, we do have some screen failures that we run into because of our stringent inclusion/exclusion criteria. We want to make sure that the lesion that we are seeing is persistent. So if we see any decrease in the lesion size between our first and screening -- second screening, we do not enroll that patient because, obviously, as you know, with this disease that there is a lot of waning and ebbing of the corneal lesion. And we want to make sure we know our drug is therapeutically effective. So we want to make sure we are really enrolling the chronic patients because it's a placebo-controlled study and our chances of winning against the placebo gets is robust. So these 2 factors has delayed NK, but we feel confident that we can get back on track and get this -- the enrollment going early next year with all these multiple sites.

Operator

Our next question is coming from Yigal Nochomovitz with Citigroup.

Yigal Nochomovitz

I just sort of have a broad one on capital allocation. Obviously, you have a lot of cash, $1.2 billion. You lowered R&D a little bit to $155 million to $165 million and your quarterly R&D spend is obviously very, very low at $15 million. So I just was kind of wondering in terms of how you think about spend, I'm just wondering, would you perhaps consider expanding and increasing on R&D, especially since some of these studies like DEB and NK and CF are taking a little bit longer. And if you invested more in each of them, perhaps you could enroll more patients and get the data a little faster. I'm just curious if you could speak to that just general thinking in terms of the way you're deploying capital.

Suma Krishnan

Thanks for the question. I would say the following. if we -- the whole point of initiating a buyback is a high level of comfort that we have enough both in terms of the revenues from VYJUVEK and in terms of supporting our pipeline before we embark on such a things such as cash buyback. And you have to -- I mean, we definitely -- in any place, whether it's NK or CF or oncology or Gorlin, if additional investment would immediately translate to either increasing enrollment or conducting a faster study or opening a site, of course, we are very open to doing that, and we have done some of that. That seems like something we should be doing and we are doing.

So I think the whole timing of the buyback was based on, look, with pricing in Germany and Italy behind us, we have much more clarity on what VJUVEK revenues could be globally and really pleased with how that is trending. We have a really good idea of the amount it would take to bring some of these pipeline products to the market in a timely manner. We also internally believe that the intrinsic value of the -- what the stock value is and what we believe is intrinsic value are dislocated at the moment. And a balance of like $1.2 billion and the $400 million gives us plenty of cushion to do all of the above.

Operator

Our next question is coming from Gavin Clark-Gartner with Evercore.

Gavin Clark-Gartner

Can I just ask for the ocular DEB, for those patients that withdrew, what exactly was the reason? Suma, I think you mentioned the patients may have gotten sick. And then a similar topic for NK, acknowledging it's been slower enrollment. Have you seen the trial completion rates, at least thus far in line with your expectations?

Suma Krishnan

Yes. I'll address the KB803 first. I mean on the DEB eye, I mean, these are patients. Remember, they're difficult patients. I mean -- so these 2 just dropped out because they were traveling and they didn't want to commit to the weekly dosing. So it was becoming -- they don't want to be -- didn't want to be compliant, so they dropped out. And as we mentioned, the third subject is because there were patients that were in a natural history study, and they were expecting to jump on to the study. Some of them came in later. And we had to stop at some point because there were more patients that were wanted to participate.

We did open up for a 1-year-old child, again, because they were very interested in this child at constant abrasion in the eye. We figured this is a younger population that we can add on the label and with request from the investigator and the patient family, we decided to enroll that patient. So just truly because we wanted to get that patient in. And we thought even if we didn't add these patients, we had enough powering for the study. But again, it made sense to add them because it didn't affect the time -- it just pushed the timeline by a few months. So that was the logic -- that was the rationale for including these additional patients in KB803. So nothing with regard to NK.

NK, again, as I mentioned, we have 21 sites up and running. We do have a bunch of screen failures. It's not because of lack of enrolling these patients because of our stringent inclusion/exclusion criteria. As you know, when you have sites open, they do want to put patients in and they put in milder patients or patients that tend to spontaneously close their lesions. So we wanted to ensure that we didn't want to enroll these patients. But now we understand with enrollment, what kind of patients, and we are actively getting additional sites in the U.S. As I mentioned, there were some academic sites that were delayed because, unfortunately, as I said, because of some of the viral safety requirements. I think we have just crossed those hurdles. So we expect with all of these academic sites up and running and the European sites up and running, we are very confident that we should be able to get back on track with enrolling NK patients.

Krish Krishnan

Gavin, just to a couple of things. You mentioned some kind of sickness, but that was a comment on KB407, not on KB803. The second point I'll make on NK is to date, the study is progressing really well, and we feel good about the limited number of patients on the trial.

Operator

Our next question is coming from Lisa Walter with RBC.

Unknown Analyst

Maybe first one for me on the NK program. Can you share how many patients have been enrolled so far or give us the benchmark? Like, for instance, are we at the halfway mark in terms of enrollment? And also on ocular DEB, should we expect to see the results ahead of the NK readout? Any color here would be helpful.

Suma Krishnan

With regarding to NK, we are not giving any guidance. But as I said, we are very confident that we should be able to get these patients -- get the study enrolled 2027. So we are doing all efforts. We don't want to give you any indication -- I mean, any numbers right now. But again, we are -- as I said, from what we see and the sites up and coming, we feel confident we -- we should be able to enroll the patients we need for that trial. On the ocular, again, as I said, we have 3 patients. The last patient out should be end of February. So again, this will be -- we'll -- once we have the last patient in, we should be shortly announcing data on KB803 first half of next year.

Krish Krishnan

Lisa, to answer your question directly, the ocular DEB will come ahead of NK at the moment.

Operator

Our next question is coming from Josh Schimmer with Cantor Fitzgerald.

Joshua Schimmer

On the quarter. This is Alexa on for Josh. So for the Hailey-Hailey disease program, maybe you can clarify a bit what you're looking for in those first 5 patients that would give you confidence to move this program forward into a registrational study?

Suma Krishnan

Hailey-Hailey is, again, this is an indication that there is no prior studies or there's no validated clinical endpoints. As I mentioned earlier, we did have -- we discussed with the FDA. We have a natural history that's ongoing that has enrolled a pretty decent number of patients. We developed a scale based on, again, we have discussions with the agency. We are -- we validated the first part of the scale. The second part of the scale should complete validation. So we're using the scale. It's an investigator-based evaluation.

So the patients come in and the investigator uses the scale to look at improvement in these patients. And we feel pretty good about the scale. As I said, Part A of the validation is completed. The Part B section should be almost done. So it will be an investigator-based evaluation. We show improvement from baseline and after treatment at the end of 3 months. We'll also be biopsying these patients at baseline and at the end of the treatment to show molybdenum correction and also expression of ---sorry, [indiscernible]. So we should have that data by end of this year.

_:p id="534984067" name="Krish Krishnan" type="E" /> And one last point. We also intend to show -- they're not easy to see, but before and after images of the area that we have been treated along with the biopsy and the scale validation improvement.

Operator

Our next question is coming from Roger Song with Jefferies.

Jiale Song

This is Fiona on for Roger. Congrats on the quarter. Just 2 quick ones from us. One is on the ex-U.S. revenue. Now with our Germany and Italy pricing negotiations completed, should we expect a more stabilized ex-U.S. revenue moving forward? Or any other factors that you expect to still contribute to the volatility? And the second one is on o DEB ocular DEB. Assuming the February completion goes smoothly and data is positive, anything else that is outstanding before the filing?

Krish Krishnan

On the ex-U.S., EU revenue, as Laurent mentioned, demand continues to grow really nicely. We're really pleased that pricing in some of the leading countries like Germany and Italy are behind us, and we're not too far away from Spain. And because there are a lot of countries and pricing hasn't been done in many of those countries, approvals will continue to be part of the story until many of those countries, at least the 5 like Italy, Spain, U.K. are behind us. Spain and U.K. are behind us. I wouldn't use the word volatility because demand continues to go up in some of the big countries. Pricing is already done, but we are excited and looking forward to bringing more and more patients in Europe on the drug as soon as possible. Germany was the big one with the approval, and that's behind us at the moment.

Suma Krishnan

Yes. On ocular DEB, I think we are all set. From a CMC perspective, we have all the requirements. I think from a BLA, we should be ready to go as soon as we have the last patient enrolled, and we have locked the database and we analyze the data. So obviously, we are working very diligently to get the BLA started. So it will be just once we have the data, we should be able to file the application shortly after that.

Operator

Our next question is coming from Alec Stranahan with Bank of America.

Alec Stranahan

Two from us, one on commercial and one on the type. I appreciate the color on the pricing negotiations. Maybe just in France, I think the press release said no earlier than 2027. Can you just remind us kind of the nuances around pricing in France specifically? And what sort of gating factors are at this point to get that completed? And then maybe one actually on the Gorlin syndrome program, which I'm surprised no one's actually asked you about. But I guess, what are you sort of working through with the FDA? What kind of size of the study do you think would be feasible in this population? And I guess since you've observed an abscopal effect, do you expect a lesion level or maybe a patient level registration endpoint for the primary?

Krish Krishnan

I'll let Laurent answer the France question.

Laurent Goux

Thank you, Krish. In France, the new President of the committee negotiating the price in terms of negotiating the price has been made clear that they usually expect a 13-month negotiation timelines. And for us, these 13 months, I mean, we are 6 months in this negotiation framework. So we are completely within the boundaries of the negotiations. Usually, the negotiations are in 2 steps. The first step is to agree on what the framework of the reimbursement will be and then entering into the more granular aspect of the pricing itself. So we are well engaged in the negotiations and it's following its normal course.

Suma Krishnan

I'll take the Gorlin question. I mean, as you can see from the 3-patient study where we looked at it, the data was pretty remarkable. We can see response in all 3 patients. I think we were also surprised to see the response. It was consistent across the 3 patients. And we were also able to confirm this by histology to show that the injected tumors that showed complete response had no BCCs in them. So again, very exciting. I mean, as you know, with Gorlin lesions do not heal on its own unlike the other. So whatever we see is a drug effect. So even if you assume placebo as a 0% response and for us to see a pretty good response, we don't expect to see this to be a large study. So again, it should be well within less than 100 patients that we should be able to do a pivotal trial if we have to, based on the response rate that we see in these 3 patients.

Operator

Our next question is coming from Andrea Newkirk with Goldman Sachs.

Andrea Tan

Suma, maybe here to follow up on NK. Could you just remind us on the inclusion criteria with respect to the expected proportion of Oxervate experienced versus naive patients? And then also just given the availability of commercial Oxervate, especially in the U.S., would you consider any protocol adjustments such as adjusted lesion windows to accelerate the accrual?

Suma Krishnan

I mean if you look at our inclusion/exclusion criteria, again, there's 2 screenings. The first screening, we look at the lesion size and obviously, it's random -- it is stratified for lesion surface area. And we -- it's pretty stringent. So even if you see like a 10% decrease between the first and the second screening, we don't enroll those patients. With regards to Oxervate, we have our inclusion criteria where the Oxervate patients have to wash out if they are in Oxervate or if they failed Oxervate and they want to get on our study. There is a 30-day washout for these patients before they can enroll on the study.

Operator

Sorry, did you have another question?

Andrea Tan

Maybe I could just ask one other question on KB407. Could you just confirm if we'll see FEV1 data in the first half of next year when that data set comes? And what threshold of lung function improvement or disease stabilization would you use the benchmark to support the plan for the pivotal program?

Suma Krishnan

Yes. We will have FEV1 data in these patients. Obviously, we are also selecting some of the natural history of these patients. So I think we will have -- I mean, it's not like a number. Hopefully, we will have it holistically. We will look at these patients, what was their lung function over the period of time and the lung function of these patients with -- on KB407. So that's what we are expecting to announce.

Operator

next question is coming from Morgan Lamberti with Goldman Sachs.

Morgan Lamberti

Can you please speak to the rate of recurrence for patients taking Oxervate? And then how that informs your view on the expected TAM for KB801 in terms of if the TAM is actually patients who have not been treated with Oxervate. Just how to think about that.

Suma Krishnan

Yes. I mean we do not really ask those questions. we are -- we do not look at the history, the sales on Oxervate or there's recurrence. We do expect some medical history at this point. It's too early to tell for us. We have not looked at all the data. But all of that, we will have collected as a medical history. We tried to calculate. But we have not -- I mean it's too early to look at that data population to make that determination.

Operator

Our final question today is coming from Kalpit Patel with Wolfe Research.

Kalpit Patel

For ocular DEB, for those 2 patients that withdrew, would those be counted in the ITT efficacy population? And any color on how you might handle incomplete crossover data in the primary analysis, that would be useful. And then for the NK program, you mentioned that you're trying to essentially trying to reduce spontaneous lesion decreases. Do we know -- is that criteria similar to how it was in the Oxervate studies?

Suma Krishnan

I'll take I'll answer the KB803 first. Yes, the 2 patients, yes, they will meet the ITT because that's the definition of ITT. Obviously, we have sensitivity analysis to capture that. And also, remember, we have the natural history of each of these patients. So in our analysis, I'm not going to get into depth of it, but we will be able to use some of that natural history study, even though with the crossover design to help with if there is any carryover effect. So all of that is taken into consideration for the statistical analysis plan for us to improve the chance of success.

Krish Krishnan

Some other question was the spontaneous lesion decrease, did Oxervate also observe that in their study?

Suma Krishnan

We don't know, but they did have an inclusion criteria for some persistence, but I can't comment on the Oxervate what was that level. But I think they did have something in the inclusion criteria. But I don't know the level of decrease for them to enroll that patient, not sure.

Operator

Thank you. Ladies and gentlemen, this does conclude today's question-and-answer session and will also conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.