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DATE
Monday, Nov. 3, 2025 at 8:30 a.m. ET
CALL PARTICIPANTS
Chairman and Chief Executive Officer — Krish Krishnan
President, Research and Development — Suma Krishnan
Senior Vice President and General Manager, Europe — Laurent Goux
Chief Accounting Officer — Kathryn A. Romano
Vice President, Corporate Development — Stephane Paquette
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TAKEAWAYS
Net Product Revenue -- $97.8 million for VYJUVEK in the third quarter, reflecting ongoing US growth and an initial contribution from Germany.
Gross Margin -- 96%, up from 93% in the prior quarter, driven by US manufacturing process optimizations; ex-US products do not yet benefit from these efficiencies.
Number of US Reimbursement Approvals -- Over 615 reimbursement approvals in the US as of Q3 2025, following acceleration across two consecutive quarters, attributed to sales force expansion and training initiatives.
Total US Prescribers -- Exceeded 450 US prescribers, showing continued penetration into community care settings.
Total Net VYJUVEK Revenue Since Launch -- Over $623 million through the end of the reported quarter.
Patient Compliance -- Remained in the low eighties percentage, consistent with prior trends for weekly VYJUVEK therapy.
Ex-US Launches -- VYJUVEK launched in Germany, France, and Japan, with pricing negotiations completed in Japan in late October and early French hospital and community access achieved.
Germany Patient Adoption -- Approximately 20 patients have been prescribed VYJUVEK at over 10 centers in Germany since the late-August launch.
French Market Milestone -- VYJUVEK awarded ASMR III by HAS, representing added clinical benefit and received under ACCEPRECOS 2, with the product first allowed gene therapy dispensation outside hospitals in France.
Prix Galien Recognition -- VYJUVEK received the Prix Galien in Italy for advanced therapy, aiding future engagement in Italy.
Pipeline Advancement -- FDA platform therapy designation granted for HSV-1 platform, initially applied to KB801, potentially accelerating approval timelines by leveraging existing manufacturing and safety data.
Cystic Fibrosis (CF) Program Update -- Interim data for KB407 to be reported before year-end, measuring molecular correction in at least three null patients using full-length CFTR expression as a key endpoint.
New Program Initiation -- IND cleared for KB111 in Haley-Haley disease, with a randomized double-blind placebo-controlled multicenter study planned for the first half of next year.
Operating Expenses -- R&D at $14.6 million in the third quarter, SG&A at $37.6 million in the third quarter, and non-cash stock-based compensation totaling $13.2 million.
Full-Year Expense Guidance Revision -- Non-GAAP R&D and SG&A now guided to $145 million to $155 million for the full year, down from $150 million to $175 million.
Net Income and Cash Position -- Net income of $79.4 million for Q3 2025 due to one-time tax and legislative benefits, with over $864 million in combined cash and investments at quarter end.
SUMMARY
Krystal Biotech (KRYS +0.17%) reported increasing global momentum for VYJUVEK, supported by additional launches in Europe and Japan and expansion of the sales force in the United States. Operational efficiencies, most notably the FDA-approved US manufacturing process optimization, drove gross margin improvements, though these effects are not yet realized in ex-US markets. Regulatory milestones were reached in France and Japan, including the ASMR III rating and successful price negotiations, establishing further access and potential reimbursement pathways. The HSV-1 gene delivery platform earned an FDA platform therapy designation for KB801, opening a route to faster clinical advancement and regulatory interaction for pipeline assets. The company advanced its clinical pipeline with near-term milestones expected for KB407 in cystic fibrosis, as well as new IND clearance for KB111 targeting Haley-Haley disease, broadening its dermatological footprint.
VYJUVEK adoption in Germany relied on expansion to more than 10 prescribing centers to alleviate start-of-care bottlenecks and facilitate decentralized patient access.
French authorities granted VYJUVEK early access and unique community-based dispensing, highlighting unprecedented flexibility for gene therapies within France.
In Japan, launches proceeded following positive pricing negotiations, and commercial infrastructure has been fully established with further revenue contribution anticipated in the subsequent year.
The company commenced global distributor partnerships for VYJUVEK to address underserved regions in Central/Eastern Europe, Turkey, and the Middle East, complementing direct market launches.
Enrollment progress and interim data timelines for major pipeline programs, including KB801 for NK and KB803 for DEB-related ocular lesions, target data-rich readouts by mid-2026.
Repeat dosing in the KB408 AATD program is active, and the complexity of site selection is shaped by bronchoscopy and lung lavage procedure requirements.
No exclusion of patients with prior ocular HSV infection in the NK study, except for those with active infection; efficacy evaluated through complete lesion healing via independent central review.
The company is not providing full-year VYJUVEK revenue guidance for 2026 due to ongoing multi-country launches and variability in adoption rates across global markets.
INDUSTRY GLOSSARY
DEB (Dystrophic Epidermolysis Bullosa): A rare genetic disorder causing severe skin fragility and blistering.
HSV-1 gene delivery platform: Krystal Biotech's proprietary viral vector system engineered for topical gene therapy applications.
VYJUVEK: Beremagene geperpavec, Krystal Biotech's lead topical gene therapy product for DEB.
ASMR III (Amélioration du Service Médical Rendu): The French Health Technology Assessment authority's rating indicating important added clinical benefit, used in pricing and reimbursement decisions.
ACCEPRECOS 2: Post-marketing early access procedure approved by the French regulatory body for certain innovative medicines.
CFFT DM: Cystic Fibrosis Foundation Therapeutics Development Network, supporting network for cystic fibrosis clinical trials.
KINITE-1 study: Ongoing Phase 1/2 clinical trial for inhaled KB707 in non-small cell lung cancer.
FEV1: Forced Expiratory Volume in 1 second; a key measure of lung function used in respiratory clinical trials.
SG&A: Selling, General, and Administrative expenses—operational costs excluding research and development and direct production costs.
R&D: Research & Development; expenditures related to product research, clinical development, and innovation.
NK (Neurotrophic Keratopathy): A rare degenerative disease of the cornea resulting from nerve damage leading to impaired healing.
AATD (Alpha-1 Antitrypsin Deficiency): A genetic disorder causing lung disease due to deficient alpha-1 antitrypsin protein.
Prix Galien: A prestigious award recognizing pharmaceutical innovation and significant advances in medical science.
MHLW: Ministry of Health, Labour and Welfare, the regulatory agency governing medical approvals and pricing in Japan.
IDN: Investigational New Drug; an application and status required to begin clinical studies in humans.
HAS: Haute Autorité de Santé, the French authority overseeing assessment of health products for medical value and reimbursement.
Full Conference Call Transcript
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Operator: And welcome to the Krystal Biotech, Inc. Third Quarter 2025 Earnings Call. At this time, all participants are on a listen-only mode. After the speakers' presentations, there will be a question and answer session. As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, 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 2025. The press release is available on our website at www.crystalbio.com. We also filed our earnings 8-Ks 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, Senior Vice President and General Manager for Europe, and Kathryn A. 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.
They 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 will turn the call over to Krish.
Krish Krishnan: Thank you, Stephane. Good morning, and welcome to the call. It gives me immense pride to realize that we are now in a position to help so many DEB patients within and outside the US. I would like to thank the entire team at Krystal Biotech, Inc. for their contributions. In Q3, VYJUVEK launch continued to build momentum and the updated US label clearly strengthens the long-term outlook in the US. We are now launched in Germany, France, and Japan. We successfully negotiated pricing in Japan and we believe the outcome bodes well for our payer conversations in Europe.
We are looking forward to our readout in CF this quarter and we are accelerating enrollment across our pipeline including KB801 for NK. We are initiating a new clinical program for Haley-Haley disease. It is a rare genetic disease of the skin that is a strong fit with our HSV-1 gene delivery platform and our commercial footprint. Suma will share more about this program later on the call. Financially, we are strong and well-positioned to execute on our strategic growth plans and deliver value to shareholders. Moving now to our 3Q results. We are pleased to report another quarter of revenue growth with net VYJUVEK revenue coming in at $97.8 million.
The patient pausing impacts due to summer holidays that we observed earlier last quarter were mitigated by patient adds and early traction in Europe. Net VYJUVEK revenues reported here do include a contribution from Europe following our launch in Germany in late August. This brings total net VYJUVEK revenues since launch to over $623 million. Gross margins were 96% for the quarter. Gross to net dynamics were stable as with prior quarters. I am happy to report continued acceleration in new reimbursement approvals in the US. Our team added over 40 new approvals since our last earnings call update, bringing the total number of reimbursement approvals in the US to over 615.
This is now our second sequential quarter of reimbursement approval acceleration and a reflection of our field team's efforts as well as the ongoing sales force expansion. Our expanded field force is now fully hired and being deployed as training is completed. Full impact is expected in early 2026. We are also happy to report continued expansion of our prescriber work, reflecting increased penetration into the community setting with a total number of prescribers in the US now exceeding 450. I would like to highlight a recent milestone achieved in the US which was the FDA approval of our updated VYJUVEK label.
This label update expanded the VYJUVEK eligible patient population to include DEB patients from birth, and also provided patients with full flexibility in how they choose to dose VYJUVEK. This change reinforces VYJUVEK's leadership position as the most flexible and convenient corrective therapy for DEB and should serve as a tailwind for adoption and compliance in the future. Compliance to weekly therapy continued the trend we reported in previous quarters coming in the low eighties as more patients achieve durable wound closure and more mild and moderate patients come on to therapy.
While the revised label change should have a positive impact on compliance in the future, we, as always, continue to expect some quarter-to-quarter waviness in the US revenues as we build on our long-term growth trajectory. With that, I will now hand it off to Laurent to share his excitement in Europe. Laurent?
Laurent Goux: Thank you, Krish. It is my pleasure to share an update on our progress in Europe. Our first European launch in Germany is off to a good start. Since launching in late August, we have seen widespread interest and demand across the country. Based on available aggregate level data, we estimate the number of patients prescribed VYJUVEK in Germany to be approximately 20. Just as importantly, we are seeing broad prescribing patterns across the country with prescriptions from over 10 centers to date. This breadth of prescribing is particularly helpful given the requirement for patients to start therapy in a healthcare setting.
By growing the number of centers prescribing VYJUVEK, we can help patients to start therapy closer to home, and avoid potential single-center patient visit bottlenecks. Based on current trends, we expect continued steady growth in patients' inclusion in the months ahead. We are also making rapid progress outside of Germany. In September, the Haute Autorité de Santé, also known as HAS, the French HTA body, approved early VYJUVEK access under the post-marketing authorization ACCEPRECOS 2. And last month, we formally launched VYJUVEK in France. Importantly, the relevant authorities in France are also allowing VYJUVEK to be dispensed outside the hospital setting.
This is the first time a gene therapy has been approved in such a setting in France, a tremendous milestone for our local team and patients across the country. Last month, HAS also priced VYJUVEK under the Amélioration du Service Médical Rendu or ASMR classification system, a key initial step for pricing and reimbursement discussions in France. VYJUVEK received an ASMR III designation. This designation, which was only granted to 11% of the new drugs reviewed in 2024, acknowledged the added clinical benefit of VYJUVEK and may open up the possibility for EU priority list pricing. Finally, I am also proud to report that VYJUVEK was granted the Prix Galien in Italy under the advanced therapy medicinal product category.
A prestigious award recognizing excellence in scientific innovation to improve the state of human health. This award is an important acknowledgment of the innovative and transformational nature of VYJUVEK, and a helpful touchpoint as we start to engage with the relevant stakeholders in Italy. With these recent achievements, we are excited about the long-term growth trajectory in Europe and maximizing VYJUVEK access to the thousands of DEB patients in the region. I will now hand the call back over to Krish.
Krish Krishnan: Thanks, Laurent. As I mentioned before, we have now also launched VYJUVEK in Japan. This summer, we were approved by the MHLW for the treatment of patients, and late last month, we successfully completed pricing negotiations with the Japanese authorities and launched VYJUVEK. We are very pleased with our pricing in Japan and that is a testament to the clinical benefits achieved by DEB patients treated with VYJUVEK. Our core Japanese team has been in place for over a year and is now fully staffed to support the VYJUVEK launch. Our Japanese medical team has also been active for over a year mapping key centers and patients which will be the early focus of our launch.
Although we expect contribution from Japan in 2025 to be modest, it will be another important revenue growth driver in 2026. Finally, I wanted to highlight one more contributor to the long-term growth of VYJUVEK. In addition to our direct VYJUVEK launches in the US, major European markets, and Japan, we started contracting with regional specialty distributors to support the commercialization of VYJUVEK in rest of the world markets. We have executed agreements in place with multiple leading distributors covering key markets in Central and Eastern Europe, Turkey, and the Middle East, and expect to add more in the year ahead.
Healthcare infrastructure and access vary significantly across rest of the world markets, but even after accounting for this variability, we estimate that a global distributor partner network could help bring VYJUVEK to thousands more DEB patients around the world and supplement our exciting growth strategy in the United States, Europe, and Japan. With that, I will now hand it off to Suma to touch on recent pipeline progress. Suma?
Suma Krishnan: Thank you, Krish. I would like to start today by acknowledging the hard work of our development team here at Krystal Biotech, Inc. In recent months, we have dramatically transformed the scope and ambition of our clinical stage pipeline, expanding our clinical programs in respiratory and oncology, and starting up new studies in ophthalmology and dermatology. These are all important achievements, none of which would be possible without the upsized contribution of each Krystal team member. Our team also achieved another important milestone in recent weeks: a platform therapy designation from the FDA.
This designation, granted for our HSV-1 gene delivery platform and currently applicable to our KB801 program, could significantly accelerate the path to approval, providing us the opportunity for more frequent interactions with the FDA and as well as the chance to leverage manufacturing and nonclinical safety data from VYJUVEK in our filings. The FDA may also consider previous inspectional findings related to drug manufacture. The platform technology designation is applied for on a program-by-program basis and is currently only granted to KB801. Although we intend to apply for this designation for additional programs, to ultimately secure the designation and associated efficiencies for our entire pipeline.
I am also excited to report that we remain on track to deliver multiple exciting readouts in the months ahead. We expect our next readout to come from our cystic fibrosis program KB407. With the backing of the CFFT DM, we have expanded our clinical trial network and are now very close to study completion. We look forward to announcing interim data before year-end, including molecular data from null CF patients to assess the ability of the HSV-1 to deliver full-length wild-type CFTR to the lung. On success, we would expect to immediately move to a repeat dosing study which would enable assessment of functionality, including longitudinal FEV1.
With our now expanded trial network and without the requirement for bronchoscopies, we expect a repeat dosing study would enroll quickly, enabling a potential FEV1 data readout next year. Our KB408 program for AATD lung disease is also moving ahead well. Having already confirmed successful delivery of functional AAT in our single-dose study, this program is in repeat dosing, and we expect to be able to provide an interim data update in the first half of next year. Together, with KB407, this will serve as a robust dataset demonstrating our platform capabilities in the lung. In ophthalmology, strong enrollment is providing us with greater clarity on the timing of our first readout.
Based on current rates, we expect to complete enrollment of our phase three trial evaluating KB803 for corneal abrasions in DEB patients by end of the year. Enrollment in a randomized placebo-controlled study for KB801 in NK is also progressing well. As we continue to onboard new sites globally, setting us up for a potential data-rich 2026. I would also like to share a quick update on our work in oncology, which is increasingly focused on the development of inhaled KB707 for the treatment of non-small cell lung cancer or NSCLC.
As we shared at ASCO over the summer, NSCLC is an indication where we have seen early evidence of monotherapy efficacy even in heavily pretreated and checkpoint inhibitor failed patients. Building on that readout, we were recently granted an end-of-phase two meeting with the FDA to discuss a potential development pathway for inhaled KB707. Based on FDA's feedback, we now expect that a single Phase III study evaluating inhaled KB707 in combination with chemotherapy, versus chemotherapy alone in patients with advanced NSCLC could be sufficient to support a potential registration in combination for second-line NSCLC.
In support of this potential registration pathway, we have opened a new cohort in our ongoing Phase 1/2 KINITE-1 study to evaluate a fixed dose inhaled KB707 in combination with chemotherapy. Enrollment in KINITE-1 is ongoing. Our current expectation is to report interim data from KINITE-1 in 2026, at which point we would also be able to provide an update on registrational study plans and potential for phase three initiation. Finally, I am also happy to introduce today a new addition to our clinical pipeline, KB111 for the treatment of Haley-Haley disease. Haley-Haley disease is a genetic blistering disease of the skin linked to the mutation in the ATP2C1 gene and low expression of its encoded cation transporting ATPase.
HHD is a rare disease with a prevalence that's not well understood. The most common estimate of prevalence is one case per fifty thousand patients, although underreporting is possible. HHD is characterized by painful rash and blistering in skin folds, with a relapsing-remitting course that is exacerbated by heat and sweat. Patients will often report debilitating symptoms of pain, itch, burning, body odor, as well as infections, resulting in severe negative impacts on quality of life, psychological distress, and intimacy issues. There are no specific therapies available for treatment of this disease.
Building on our experience and clinically validated HSV platform for skin delivery, we designed KB111 to deliver ATP2C1 directly to skin cells, increase ATPase levels, and hopefully change the course of this terrible disease. As with VYJUVEK, KB111 is formulated for topical administration directly to the lesions of HHD patients. We have already confirmed in preclinical studies that KB111 can efficiently transduce skin cells resulting in functional ATPase expression, and last month, cleared our IND. We expect to start an intrapatient randomized double-blind placebo-controlled multicenter study evaluating KB111 in HHD patients in the first half of next year.
With strong execution across our pipeline and now the added benefits of the platform designation for KB801, we are well-positioned to make rapid progress with multiple readouts in the months ahead. With that, I will hand the call over to Kate.
Kathryn A. Romano: Thank you, Suma, and good morning, everyone. I would like to provide some highlights from our third quarter financial results reported in our press release and 10-Q filing earlier this morning. VYJUVEK net product revenue for the third quarter was $97.8 million. This marks sustained growth as compared to the prior quarter, including the early sales from our German launch. Gross to net revenues remained consistent with prior quarters. Cost of goods sold was $4.3 million and gross margin was 96% for the quarter, as compared to 93% last quarter.
Note that the increase in gross margin this quarter was the result of US product manufacturing process optimizations, and the benefit of lower cost batches after FDA approval of this optimized process. While we expect these manufacturing efficiencies to continue benefiting our US operations, the optimized process has not yet been approved for products sold outside the United States. As ex-US sales grow over the coming quarters, we anticipate gross margins will normalize towards historical levels until the optimized process is approved for products sold outside the United States. Research and development expenses were $14.6 million and general and administrative expenses were $37.6 million. Operating expenses for the quarter included non-cash stock-based compensation of $13.2 million.
You will note on slide 13 that we are revising our full-year non-GAAP R&D and SG&A guidance to $145 million to $155 million compared to our prior guidance of $150 million to $175 million. This represents both a reduction and narrowing of the range to better reflect our performance so far this year as well as our continued confidence in our ability to execute with discipline for the remainder of the year. During the quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets, reflecting our confidence in Krystal Biotech, Inc.'s future profitability. This release resulted in a one-time non-cash tax benefit that increased our reported EPS.
We also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation. This reversal was also non-recurring. Net income for the quarter was $79.4 million, which represented $2.74 for basic and $2.66 per diluted share reflective of these one-time benefits. And finally, our balance sheet continues to be a key point of strength for Krystal Biotech, Inc. We ended the third quarter with over $864 million in combined cash and investments, and we remain well-positioned to support our commercial launches globally as well as our significant pipeline programs in the upcoming quarters. And now I will turn the call back over to Krish.
Krish Krishnan: Thanks, Kate. As we close today's call, I would like to emphasize our excitement for the path ahead at Krystal Biotech, Inc. in 2026. With launches in Germany, France, and Japan, VYJUVEK has now truly gone global, providing us the opportunity to dramatically expand the number of patients benefiting from VYJUVEK therapy in the months ahead. The hard part of a global VYJUVEK launch is now behind us, and Krystal Biotech, Inc.'s focus in 2026 is on our clinical pipeline. We have our first readout in CF before year-end, we are working towards readouts in KB801 for NK and KB803 for eye lesions in DEB patients by midyear, and we shall update once enrollment is complete in these programs.
These programs, along with KB111 for Haley-Haley, fit neatly within our core global commercial capabilities. At the same time, we recognize the significant optionality that HSV-1 provides as a redosable non-integrating large capacity 1 on your phone at this time. We ask that while posing your question, you please pick up your handset listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Your first question for today is from Alec Stranahan with Bank of America.
Alec Stranahan: Hey, guys. This is Matthew on for Alec. Congrats on the quarter. Appreciate you taking our questions. Maybe just two from us. On the ex-US launch, I guess whether your focus is on expanding the breadth of prescribers or depth of prescribers that have already made some prescriptions? And then maybe on the optimized process, that led to better gross margins. Just curious you know, what was sort of optimized in this process and whether you can speak to timelines. For this optimized process to be expanded to ex-US markets. Thanks.
Krish Krishnan: Thank you, Matthew. Hey, in terms of your first question on ex-US launch breadth of prescribers versus depth, I mean, our focus, I mean, you know our objective in Europe is primarily to celebrate getting a patient to meet the physician as soon as possible because the first clinical visit has to be in a physician. Now purely logistically, that's a lot easier if you start focusing on centers of excellence as you heard from Laurent to begin with, but at the same time, slowly spreading out into the community. On the question about optimized process, this is essentially moving to a larger bioreactor. It's got approved in the US. And we are working towards an application in Europe.
I'll ask someone to comment on the timing with respect to the optimized batch.
Suma Krishnan: Five months here. Approval in Europe. I mean, we have already started the process. We have filed the scale up. I mean, it's pretty straightforward because we have a lot of data from the US. So we expect, hopefully, sometime next year to have the optimized and scaled up process approved. Good. Thanks.
Operator: Your next question is from Roger Song with Jefferies.
Roger Song: Great. Congrats for the quarter, and thank you for taking our question. Also related to the question on ex-US launch. So understand the contribution in March, probably not too much from Germany. But you're curious about your expectation moving to year. I mean, before Q and the next year, how should we think about ex-US versus the US revenue contribution and when on ASP will give us some breakdown data on. And then also related to related to this ex-US launch is how should we think about the pricing. Understand you, you need to negotiate on top of the list of price. And then how this will change over time, particularly with the USMFM policy? Thank you.
Krish Krishnan: Great, Roger. Thanks for both those questions. Look. I you know, the only requirement as I mentioned in the prior response, is to start in a healthcare setting. But in spite of that, we think Germany is off to a really good start with, like, 10 plus centers, starting to prescribe. But only point I'll make with respect to the EU launch I would expect it to be a steady launch upwards. As opposed to expecting any kind of bolus early on in either country, whether it be Germany or France. But the demand and the physicians and the patients are pretty excited. I would say, both in Germany, France, and Italy is starting to go that way too.
With respect to pricing, look. We know Germany efforts free pricing for the first six months. And then internally, we'll make a determination to start accruing for the next twelve months. Depending on how pricing's proceeding. Negotiations are proceeding, in France, obviously, we start accruing from day one. So it's very country specific. But I will say, based on the ASMR rating, based on the pricing we got in Japan, I think it bodes well. It remains to be seen, but I think the efficacy and the debilitating nature of the disease I think that message, we are doing a really good job of conveying that. And it's being received well. By these authorities in different countries.
Roger Song: Got it. Thank you.
Operator: Your next question for today is from Ritu Baral with TD Cowen.
Ritu Baral: Hi, guys. Apologies. I was muted. Good morning. Thank you for taking the questions. I have been getting a lot of questions on NK timing. And, Krish, could you us through sort of what the gating aspects of getting that trial up and going is. You know, how many sites and how difficult it is to open those sites have has enrollment formal enrollment actually started. I think there's a lot of focus on the rapidity of getting to data and what that says about the overall NK population prevalence. And then I have a quick follow-up on CF.
Krish Krishnan: Gotcha. On NK, it's I will just say, look. I think we have started to enroll patients in the study. Maybe, Suma, you could add some color on we're proceeding. I mean, we have we have quite a few sites up and running. We are actively adding additional sites. So really, intend not just in the US, but globally because there's a lot of NK patients in Europe and the rest of the world, and we want to make this a global filing.
So, as you know, it takes a little while to up them up and running for the global studies, but we are right in the process, I think, we will have most of our sites all completely signed up and ready to go, hopefully, by end of the year. And as you know, we are enrolling patients. This is one of our top priority projects. So we are excited to see the, you know, the progress on this particular trial.
Krish Krishnan: And I will add, Ritu, our internal timing target is to announce some kind of interim data by the middle of next year.
Ritu Baral: Got it. And, like, can you say what percentage of sites do you have up at the percentage of plan sites that you have up in running at this point?
Suma Krishnan: I mean, we have quite a few sites. I mean, within the US, we got most of the academic sites up and running. We have a few more to go, but I think we should have most of the US sites up and running by end of the year.
Ritu Baral: Got it. And then for CF, can you tell us how many null patients that you plan to provide data on by the year-end update? And so what constitutes success on molecular response? What aspects of molecular response will you be reporting and what success in a mold patient? Yeah. We're Regent, thanks.
Krish Krishnan: For that question. We are looking at a minimum three null patients. Primarily focused on molecular correction, because it's a single-dose study. Suma, anything else?
Suma Krishnan: Yeah. I mean, obviously, we are bronchiing these patients these three null patients. After the drug is administered. And the biopsies, we will take a the different, you know, across all the different areas of the lung, and we will look for expression of CFTR by immunofluorescence across. And we will see, what kind of, you know, expression. We are expecting to see robust expressions. I mean, based on our primate study, I mean, this hopefully, if we can recreate that, we see expression all the way up to twenty-eight days. We see full-length molecular CFTR expression across you know, all of our biopsies. We think we feel pretty confident. Nobody is able to today, so full-length expression of CFTR.
So, hopefully, you know, we can break that cycle. That's our goal.
Ritu Baral: Will you will you as, like, percentage of normal and sort of what threshold could result in FEV changes at a later time point?
Suma Krishnan: I mean, we know that you do not need much. Right? Even these patients do not produce any CFTR. So even if we can produce, you know, anywhere between five to ten percent of CFTR, expression. I think that's pretty robust. So, again, our intent is in these multiple biopsies across you know, the across the lung, we will hopefully, we want to show expression in, you know, most of these biopsies, and that will give us some confidence that, yes, we can express, and we have enough molecular correction. So especially these now patients produce any CFTR.
Ritu Baral: Got it. Thanks for taking all the questions.
Operator: Your next question is from Gavin Clark-Gartner with Evercore.
Gavin Clark-Gartner: Hey, guys. Thanks for taking the questions. On NK, makes you confident that you do not need to test any different doses and why the one that you picked is the right dose and somewhat on this topic. Do you think you need two efficacy studies for approval, or may one be sufficient?
Suma Krishnan: So the confidence for the dose comes from our animal studies. I mean, we clearly see expression gave a clear pharmacokinetic profile. We know how long the expression lasts. So that is guided us into the dosing regimen in the clinic. Yes. We feel pretty sure that we just need one efficacy trial because this is, again, a rare disease. It meets the regulatory guidance for what the requirement is. So based on our study and the way we have powered the study based on know, our animal studies and what oxalate studies have achieved. We have powered it to hopefully see clinical significant improvement from placebo. So that's the goal of this. Study is successful.
Then we expect this to be the registrational trial. And, obviously, you have the platform technology. And we have guidance on, you know, what we need a CMC perspective. So we are I think you're aligned. So that's that's something that's, you know, positive for this program.
Gavin Clark-Gartner: And is there any commentary you can provide on the safety you're seeing in the ocular deb study or the NK study on a blinded basis?
Suma Krishnan: I mean, so far, we have not seen any adverse events of concern.
Gavin Clark-Gartner: Alright. Great. Thanks.
Operator: Your next question is from Samantha Danielle Corwin with William Blair.
Samantha Danielle Corwin: Congrats on the progress, and thanks for taking my questions. I also have one on NK. Could you remind us if you're excluding patients that, have had a prior ocular HSV infection. And if you think a prior HSV infection could impact the efficacy or safety of treatment. And then in terms of the initial dataset, what exactly will we see in that? Thank you.
Suma Krishnan: Regarding to your first question, no, we do not we do not exclude patients that had prior infection. Only requirement is they should not have an active infection. That's the only exclusion criteria. I mean, that so what are we gonna announce? Yeah. Data said this is a randomized one-to-one placebo-controlled study eight week. So we look at complete healing using, you know, I mean, complete healing with an independent reader. So if you see complete healing at any against placebo, then that's a win. Just exactly like oxovate.
Samantha Danielle Corwin: Got it. Great. And then just one question on VYJUVEK. Could we expect some guidance or full-year revenue guidance for VYJUVEK early next year?
Krish Krishnan: No. Because we will have so many launches and the distribution you see, right, it will take us some time to kind of get comfortable with how the different launches are going in different countries. So fortunately, Sami, we will not be guiding on revenue for 2026.
Samantha Danielle Corwin: Got it. Thank you.
Operator: Your next question is from Joshua Elliott Schimmer with Cantor Fitzgerald.
Joshua Elliott Schimmer: Hi. This is Alexa Demer on for Joshua Elliott Schimmer, and congrats on a great quarter. So can you please provide some more color on the contribution of US and ex-US sales in the third quarter for VYJUVEK? More specifically, what was the percentage breakdown from the US versus Germany?
Krish Krishnan: Yeah. Look. The decision not to break down in this particular quarter was somewhat accounting audited driven, and the goal is to establish a consistent long-term practice on segment reporting if you follow that thought, we will be starting to break down geographies at some point in 2026. It's just that now it is so modest a contribution relative to the overall net revenues of the company.
Joshua Elliott Schimmer: Okay. Got it. And can you provide any more specifics on how US sales were in the second quarter versus the third quarter?
Krish Krishnan: Yeah. Definitely. You know, I would say that the US was a was a bit lower than what we saw in February. But not to the extent, like, based on my comments from the last quarter, definitely, reimbursement approvals were on an uptick. And so overall, we ended up getting to a number that was higher than Q2.
Joshua Elliott Schimmer: Got it. Thanks so much.
Operator: Your next question for today is from Andrea Newkirk with Goldman Sachs.
Morgan Jane Lamberti: Hi. This is Morgan on for Andrea. Thank you for taking our question. With 615 reimbursement approvals, what do you attribute this growth to? Are you seeing more patient adds from the community setting? And then how are you thinking about the path to 60% penetration from here? Thank you.
Krish Krishnan: Now great question, Andrea. Look. Like I mentioned, maybe last quarter or the one before, it was taking us a bit longer to pull through a start form. As we are getting patients more out in the community and physicians who are not who are far away from a center of excellence. And by just increasing the size of the sales force, we I believe we have turned that issue around. We saw some acceleration last quarter. We see a continued acceleration this quarter. We expect that to go forward as more reps are being trained and out into the field. In terms of 60% market share, look, that's a number around 720. We reported 615.
So we're maybe a quarter or two from hitting that number. If you just do a simple math on that on that metric, which so we feel really good about the way the launch is going. And how we've been able to reverse this the one or two one quarter of deceleration in RA.
Morgan Jane Lamberti: Great. Thank you so much.
Operator: Your next question is from Yigal Dov Nochomovitz with Citi.
Yigal Dov Nochomovitz: Hi. This is Johann Kim on for Yigal. Thanks for taking our question. Maybe just two quick ones for from us on KB408. You just talk a little bit about your expectations there, whether you're expecting a significant uptick in AAT with repeat dosing versus a single dose and what sort of boost you'd be expected to see, or would you want to see?
Krish Krishnan: Yeah. Obviously, we're expecting an uptick, but we're not particularly talking right now about how much of an uptick. But I mean, we are doing repeat dosing of the AAT I mean, of 408. We'll be collecting bronch and lavage samples. So that's something that's ongoing. So once so we will show repeat dosing and an expression of AAT.
Yigal Dov Nochomovitz: Got it. And can you speak on whether opening up more sites is also a priority for that program to continue enrolling patients given that there are quite a number of AAT programs ongoing right now?
Suma Krishnan: I mean, right now, we have a couple of sites that's open because remember, again, these sites have to be able to do bronchoscopy. In case of 408, it's a little more complex because it's not just biopsies. They also need to take lung lavage fluids out to measure the AAT and the protein level. There's only few sites that are you know, that are capable of doing this. So we have those sites. Have the patients. So, hopefully, once we finish that cohort with the repeat dose administration and AAT levels, and we hope to, you know, have a meeting with the agency to potentially talk about a path forward.
Yigal Dov Nochomovitz: Got it. Thank you.
Operator: There are no further questions in queue.
Operator: Thank you. We've reached the end of the question and answer session and today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.