Good morning and thank you for standing by and welcome to Crystal Biotech's third quarter 2026 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentations, there will be a question and answer session. During the question and answer session, there will be a limit of two questions per participant. As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Senior Vice President of Corporate Development. Please begin.

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.crystalbio.com. We also filed our earnings 8K and 10Q 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. Your caution 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 file. With that, I will turn the call over to Krish.

Good morning, and thank you for joining us. Q3 was another strong Q for Crystal. We delivered $127.3 million in Visevic 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 Crystal into a global company with commercial operations, manufacturing capabilities, clinical development programs that we own and control. And today, we have generated approximately $1.1 billion in ViseVec revenue since launch, and that is an important milestone for a medicine developed here at Crystal. 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 patients' thoughts across Germany, France, and Japan. The pricing secured for Vajavec in Japan and Germany and Italy today reflects recognition of the meaningful benefits that Vajavec 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 Golan Syndrome Day clinical results that demonstrated regression 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 two 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 Crystal's long-term prospects and our responsibility to allocate this capital thoughtfully. So taken all together, this queue 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 work through commercial, clinical and financial updates.

Thank you, Krish. By Jouvec International Revenue, which $32 million in the third quarter, we continue to translate physician interest into patients' thoughts while strengthening the growth foundations 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 VIJUVEC, 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 extend 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 DEB community maximize the potential benefits of viduvex therapy and navigate the complexity of viduvex GMO status. Looking ahead, pricing and reimbursement negotiations in Italy have also concluded. and we now expect to launch VIJUVEC in early 2027. In Spain, pricing discussions are progressing with a decision expected before the end of the year. Some patients already have access to 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 Vajuvex reach over time. Taken together, these developments give us confidence in the international opportunity. Health systems are recognizing Vajuvex 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.

Thank you, Laurent. U.S. net revenue for the third quarter was $95.3 million, reflecting continued demand for VigeVac 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 Vigevec, 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 Vizuvac Voices and Vizuvac 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 DEV 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 Viagavec 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 Viagavec as the long-term standard of care for patients living with them. With that, I'll turn the call over to Suma.

Thank you, Christine, and good morning, everyone. We have encouraging progress to share this morning, including our initial Garland syndrome results, the upcoming Haley-Haley 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, KB113 for Garland syndrome. Garland syndrome is the rarest 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 Garland syndrome, there is a substantial need for a safe, effective treatment to reduce BCC burden. KB707 is our HSV-1-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 intratumor KB707, which we now refer to as KB113, in three adult patients with Corlin syndrome. Each received six doses over 14 weeks. Investigators assessed regression in both injected and non-injected landmark BCCs throughout treatment and 30 days after the final dose using a pre-specified five-point scale. Profound treatment benefits were observed following KB113 treatment, including broad anti-tumor responses in all three Garland syndrome patients. As summarized in the table on the left, over 80% of the assessed lesions 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 SF tumors had shrunk by at least 90%, indicating potential for tumor eradication with KB113 treatment. To further assess depth of response, one injected tumor from each patient was biopsied for histological assessment. In all three 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 Coughlin 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've already started engaging with FDA regarding potential clinical development pathways in Garland 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 five 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 VBAC program are progressing well. In the case of KBA03, we enrolled three additional patients in our registrational ILI study. Two of these additional patients have been enrolled to replace two patients who withdrew for reasons unrelated to safety. The third patient, a child one year of age, was enrolled to generate evidence to support potential treatment of corneal abrasions in dead patients from birth. We now expect that the last patient last visit in February, 2027 with top line results to be reported shortly thereafter. NKB 801 for NK patients enrollment have 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, 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 three patients in our repeat dose study and expect to enroll and dose three 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 in-health KB707 program, enrolling patients with advanced NSCLC and the global KINITE1 expansion cohort, evaluating in-health 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.

Thank you, Suma. I'll now provide a few additional highlights from our third quarter financial results as reported in our press release and 10Q filing earlier today. Net revenue from global sales of Vigevec 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 product 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 non-cash 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 non-recurring. 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 to $165 million from our prior guidance of $175 to $195 million. 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.

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 VizioVac growth internationally. We have a rich pipeline with several important readouts in the upcoming months, and as I said before, the initial goal and findings are very encouraging and we look forward to the upcoming Haley Haley 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 Crystal'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. Thank you.

Thank you. At this time, we'll be conducting our question and answer session. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. I would like to remind you to please limit yourself to two questions. Thank you. Please hold while we poll for questions. Our first question today is coming from Lachlan Hanbury-Brown with William Blair. Your line is live.

Hey, guys. Thanks for the question and congrats on all the progress.

I guess the first question may be on KB407. You said you're enrolling in additional three patients. I was wondering on the rationale for that. I mean, you're wanting to test a different dose. Is that something that you've seen in the first few patients that That makes you a larger sample here. And then on the second question, wondering about Japan, you know, 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 one year mark, wondering how we should think about the sort of acceleration of growth in Japan moving forward.

Thanks, Lachlan, for the question, Suma.

I can address the 803. Sorry, I can address the 407 question. Sorry, 407. Yeah, I mean, we have three patients right now. They're ongoing on the repeat dosing. It has nothing to do with the dose. I mean, we're very excited. I mean, these patients are tolerating repeat dose. That was one of the biggest questions we had to address with regarding to, you know, safety. And obviously, we're collecting FEV1 data. The enrollment for these additional three 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. Remember, these are patients that are null and with no other options. So it is their life events that actually pushed out. But I think we feel confident that all the patients will get on the study and we expect to have this data by middle of next year.

Hey, on the Japan question, I mean, that's valid like that. In the next, I think, upcoming, I don't remember the timing, but it 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.

Thanks.

Thank you. Our next question is coming from Ritu Baral with TD Cohen. Your line is live.

Good morning, guys. I wanted to keep my two questions to 801 and 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 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 on potential timing in 2027? Thanks.

Thank you. So I'll address this question. You know, we are expanding additional sites in the U.S. We have another 10 to 15 sites. Unfortunately, the academic sites, you know, the big ones that have the patients have been delayed because of contracts. And remember, this is a, you know, GMO and it's going to be home administered. So we ran into some glitches with them, but we're overcoming all these sites. So we expect many of these academic sites with 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, you know, Oxovate is available to these patients as you know, Oxovate is being aggressively marketed in the U.S. So I think we, you know, we have an opportunity in the U where Oxovate is not available. We are, we have talked to sites, they have a lot of patients. We are in the process of actually, you know, activating all of the sites. So we are We are going pretty aggressively and getting multiple sites across the EU region and even Eastern Europe to get to actually really improve our enrollments. 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 ran into because of our stringent inclusion-exclusion criteria. We want to make sure that The lesion that we are seeing is persistent. So if you see any decrease in a lesion size between our first and second screening, we do not enroll that patient because obviously, as you know, with this disease, 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 is robust. So these two factors have delayed NK, but we feel confident that we can get back on track and get the enrollment going early next year with all these multiple sites.

Thank you. Our next question is coming from Yigal Nachamovitz with Citigroup. Your line is live.

Yeah, hi. Thanks very much for taking the questions. 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 to $165, and your quarterly R&D spend is obviously very, very low at $15 billion. Million. So I just was kind of wondering, you know, in terms of how you think about spend, I'm just wondering, would you perhaps consider, you know, 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, you know, enroll more patients and get to 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. Thank you.

Hey, thanks for the question. I will say the following. The whole point of initiating a buyback is a high level of comfort that we have enough both in terms of the revenues from Biotech and in terms of supporting our pipeline before we embark on such a thing as a cash buyback. And you have to I mean we definitely if in any place whether it's NK or CF or oncology or Gordland if additional investment would immediately translate to either increasing enrollment or conducting a FASTA 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 visual 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 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 $400 million gives us plenty of questions to do all of the above. Okay.

Thank you very much.

Thank you. Our next question is coming from Gavin Clark Gertner with Evercore. Your line is live.

Hey guys, thanks for taking the question. 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 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? Thanks.

Yeah, I'll address the 803 first. I mean, on the DEBI, I mean, these are the patients. Remember, they are, you know, they're difficult patients. I mean, so these two just dropped out because they were traveling and they didn't want to commit to the weekly dosing. So it was becoming, you know, 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, I mean, there were patients that were in a natural history study and they were expecting to jump onto the study. Some of them came in later and we had to stop at some point because there were more patients that wanted to participate. We did open up for a one-year-old child again because they were very interested. The child had constant abrasion in the eye. We figured this is a younger population that we can add on the label with requests from the investigator and the patient's family. We decided to enroll that patient. So it was 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 rationale for including these additional patients in 803. 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 virus 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.

Hey, Gavin, just a couple of things. You mentioned some kind of sickness, but that was a comment on 407, not on 803. 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. All right, great. That's super helpful. Thank you.

Thank you. Our next question is coming from Lisa Walter with RBC. Your line is live.

Oh, good morning. Thanks for taking our questions.

Maybe first one for me on the NK program. Can you share how many patients have been enrolled so far or give us a 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. Thanks so much.

And 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 the patient, get the study enrolled 2027. So we are doing all efforts. We don't want to give you any, you know, I mean, any numbers right now, but again, as I said, from what we see and the sites up and coming, we feel confident we should be able to enroll the patients we need for that trial. On the ocular, again, as I said, we have three patients. The last patient out should be end of February. So again, once we have the last patient in, We should be shortly announcing data on 803 first half of next year.

Lisa, to answer your question directly, the Ocular DEP will come ahead of NCARE at the moment.

Got it. Thanks so much.

Thank you. Our next question is coming from Josh Shimmer with Cantor Fitzgerald. Your line is live.

Hi guys, congrats on the quarter. This is Alexa on for Josh. So for the Haley-Haley disease program, maybe you can clarify a bit what you're looking for in those first five patients that would give you confidence to move this program forward into a registrational study. Thanks.

Haley-Haley, 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 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 scales 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 to show improvement from baseline and after treatment at the end of three months. We'll also be biopsying these patients at baseline and at the end of the treatment to show molecular correction. and also expression of AATCP protein. So we should have that data by end of this year.

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've been treated along with the biopsy and the scale validation improvement.

Okay, awesome. Thank you so much.

Thank you. Our next question is coming from Roger Song with Jefferies. Your line is live.

Hi, guys. This is Fiona for Roger.

Congrats on the quarter and thanks for taking our question.

Just two quick ones from us. One is on the ex-US revenue. Now is our Germany and Italy pricing negotiations completed. Should we expect a more Stabilize the ex-U.S. revenue build moving forward or any other factors that you expect can still contribute to the volatility? And the second one is on ODAB, OCRDB. Assuming the February completion goes smoothly and data is positive, anything else that is outstanding before the filing? Thank you.

Hey, on the ex-U.S. 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, accruals will continue to be part of the story until many of those countries, at least the five like Italy, Spain, UK, are behind us. Spain and UK 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. But Germany was the big one with the accrual and that's behind us at the moment.

Yeah, on ocular DEB, I think we're 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, you know, get the BLA started. So it would be just once we have the data, we should be able to file the application shortly after that. Super helpful.

Thank you.

Thank you. Our next question is coming from Alex Stranahan with Bank of America. Your line is live.

Hey, guys. Thanks for taking our questions. Two from us, one on commercial and one on the pipe. Appreciate the color on the pricing negotiations. Maybe just in France, I think the press release said no earlier than 2027. Could 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 actually asked you about. But I guess what are you sort of working through with the FDA? What kind of size of a study do you think would be feasible in this population? And I guess since you've observed an upscalable effect, do you expect a lesion level or maybe a patient level registration endpoint for the primary. Thank you.

Laurent, I'll let Laurent answer the French question.

Thank you, Krish. In France, the new president of the committee negotiating the price, in charge 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 six months in this negotiation framework so we are completely within the boundaries of the negotiations. Usually the negotiations are in two 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.

I'll take the golden question. I mean, as you can see from a three-patient study where we looked at it, the data was pretty remarkable. You can see response in all three patients. I think we were also surprised to see the response. consistent across the three 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, gorlin lesions do not heal on its own unlike others. So whatever we see is a drug effect. So even if you assume placebo is a 0% response and for us to see a pretty good response. We don't expect to see, you know, have this to be a large study. So again, you know, it should be well within less than 100 patients that we should be able to do a pivotal trial if you have to, you know, based on the response rate that we see in these three patients.

Thank you.

Thank you. Our next question is coming from Andrea Newkirk with Goldman Sachs. Your line is live.

Good morning. Thanks for taking the question. Suma, maybe here to follow up on NK, could you just remind us on the inclusion criteria with respect to the expected proportion of OxyRV experience versus naive patients? And then also just given the availability of commercial OxyRV, especially in the U.S., Would you consider any protocol adjustments such as adjusted lesion windows to accelerate the accrual? Thanks so much.

I mean, if you look at our inclusion-exclusion criteria, again, there's two screenings. The first screening, we look at the lesion size, and obviously it's random. It is stratified for lesion surface area. And 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 Oxovate, we have our inclusion criteria where the Oxovate patients have to wash out if they are on Oxovate or if they failed Oxovate and they want to get on our study. There is a 30-day washout for these patients before they can enroll on the study.

Thank you.

Sorry, mom, did you have another question?

Oh, no, thank you so much. Yeah, maybe I could just ask one other question on 407. 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 view as the benchmark to support the plans for the pivotal program? Thanks again.

Yes, we will have FEV1 data in these patients. Obviously, we are also collecting 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 are their lung function over the period of time, and the lung function of these patients on 407. So that's what we are expecting to announce.

Thank you. Our next question is coming from Morgan Lamberti with Goldman Sachs. Your line is live.

Hi, team. Thanks for taking our question. Can you please speak to the rate of recurrence for patients taking Oxyvates 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 Oxyvates? Just how to think about that. Thank you so much.

Yeah, I mean, we do not really ask those questions. We do not look at the history, the field of the weight of this recurrence. We do collect 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. It's too early to look at that data population to make that determination.

Thank you.

Thank you. Our final question today is coming from Kalpeet Patel with Wolf Research. Your line is live.

Yeah, hey, good morning and thanks for taking the questions. For Ocular Deb, for those two 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 essentially trying to reduce spontaneous lesion decreases. Do we know, is that criteria similar to how it was in the OxyRate studies? Thanks for taking the questions.

I'll answer the 803 first. Yes, the two patients, yes, they will meet the ITT because that's the definition of ITT. Obviously, we have, you know, 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 the depth of it, but we will be able to use some of that natural history study, even with the crossover design to help with if there is any carryover effect. all of that is taken into consideration for the statistical analysis plan for us to improve the chance of success. N.K.

Some of the question was the spontaneous leak in the grease. Did OxoVate also observe that in their study?

We don't know, but they did have an inclusion criteria for some persistence, but I can't comment on the OxoVate 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.

Got it. Okay. Thank you very much.

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.