Krystal Biotech Q4 2025 Earnings Call - Ex-US VYJUVEK Rollout to Drive 2026 Growth, Registrational Readouts Ahead

Conference Operator: Thank you for standing by, and welcome to the Krystal Biotech Q4 2025 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. As a reminder, today’s conference is being recorded. I would now like to hand the conference over to your host, Stéphane Paquette, Vice President of Corporate Development.

Stéphane Paquette, Vice President of Corporate Development, Krystal Biotech: Good morning, and thank you all for joining today’s call. Earlier today, we released our financial results for the fourth quarter and full year of 2025. The press release is available on our website at www.krystalbio.com. We also filed our earnings, 8-K and 10-K with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer, Suma Krishnan, President of Research and Development, Christine Wilson, Senior Vice President and Head of U.S. Commercial, Laurent Glux, Senior Vice President and General Manager for Europe, 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, Chairman and Chief Executive Officer, Krystal Biotech: Thanks, Stéphane. Before I begin, I want to recognize Suma for being named to the innovator list. The concept of enabling repeat dosing of a genetic medicine in a home setting by the patient is truly innovative. So congrats, Suma. Stepping back, I’m very pleased with where we are at Krystal. On the commercial side in 2025, we’ve made meaningful progress across all geographies. In the U.S., we added sales capacity and successfully re-accelerated demand. In Europe, despite the country-by-country nuances, we launched a genetic medicine that can be applied in a home setting by a patient. In Japan, we leveraged the attributes of VYJUVEK to establish a strong value proposition for patients. We continue to broaden VYJUVEK access globally. To date, we’ve signed distributor agreements covering more than 20 countries, and our goal is to expand to over 40 countries in 2026.

More importantly, the patient stories that we continue to hear about how VYJUVEK is changing lives remains deeply motivating for our entire team. On the pipeline, we’re currently in the middle of two registrational trials in NK and in treating eye lesions in DEB patients, with the potential to initiate two additional registrational programs in CF and Hailey-Hailey later this year. Together, that positions us well for the next five years, and we believe that if approved, we have the capabilities to self-launch these four indications. Meanwhile, the oncology and the Alpha-1 trials continue to progress well. None of this would be possible without the dedication of the Krystal team, and I’m grateful for their commitment and execution. Overall, Krystal is building a durable commercial gene therapy company with disciplined capital allocation.

We’re generating strong gross margins and operating profitability while expanding global access for VYJUVEK and advancing a focused pipeline. Our operating principle is straightforward: invest behind measurable execution milestones, compound value without relying on dilution, and work diligently to get the next pipeline medicine approved. Turning now to results. We’re pleased to report another quarter of revenue growth with net VYJUVEK revenue of $107.1 million in Q4. That brings total net VYJUVEK revenue since launch to over $730 million. The net revenue reported this quarter includes contributions from Europe and Japan as we build momentum in our initial overseas markets. Christine and Laurent are both here today and will share more country-level color in a moment. Gross margin was 94% for the quarter and 94% for the full year.

We continue to expect gross margins in the 90%-95% range for the foreseeable future. With that, I’ll turn it over to Christine to provide an update on the U.S. commercial performance.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech: Thank you, Krish. We remain very encouraged by the VYJUVEK launch and the momentum we are seeing in the U.S., which continues to support our long-term commercial outlook. I’m pleased to share that we have now seen reimbursement approval acceleration for three consecutive quarters, with over 660 since launch, reflecting strong execution by our commercial organization. As we continue to expand our reach into the community setting, we added over 50 new prescribers in Q4 2025 and have reached over 500 unique prescribers since launch. With our expanded sales force now fully trained and deployed, we are also seeing continued improvement across key demand metrics. The impact of our expanded sales force is supporting broader patient identification across the United States, including patients with DDEB that are being treated by local dermatologists or primary care physicians.

It is encouraging to see the benefit that VYJUVEK is providing to patients across the full spectrum of disease severity, from severe cases to mild and moderate presentations. Patients are achieving durable wound closure, which in many cases is allowing them to transition to as-needed utilization of VYJUVEK over time. Importantly, our commitment to the DEB community remains unwavering. As the market continues to evolve as expected through the launch, we remain focused on optimizing our processes to better support patients and providers. We continue to execute on this through strong partnerships with advocacy organizations and centers of excellence, ongoing feedback from HCPs and patients gathered through objective market research, and a continued focus on driving operational improvements and advancing the standard of care. I will now hand the call off to Laurent to share updates on the VYJUVEK launch overseas. Laurent?

Laurent Glux, Senior Vice President and General Manager for Europe, Krystal Biotech: Thank you, Christine. It is my pleasure to share the latest on our operations outside the US, including an update on Japan on behalf of our colleagues. I’m proud to report that our global VYJUVEK launch continues to progress very well. The high patient demand we’re seeing across our very different markets validates the transformative impact VYJUVEK brings to the dystrophic epidermolysis bullosa patients and their families. We now estimate that over 90 DEB patients have been prescribed VYJUVEK across Germany, France, and Japan combined. Our launch in Germany continues to build momentum since late August of last year. We’re seeing sustained prescription growth and good prescribing breadth. The initial centers of excellence are now routinely prescribing VYJUVEK, and we are expanding into the broader community setting.

This geographic distribution is critical for patient access, as it allows DEB patients to initiate therapy closer to home, reducing the burden on both patients and individual treatment centers. After initiation in a center, most of the patients are already benefiting from home administration. In France, our launch is progressing well under the AP2 early access program. The AP2 program is functioning exactly as designed, providing eligible patient access to VYJUVEK while we complete our negotiations with the French health authorities. Importantly, subject to the early access conditions, physicians and patients are demonstrating strong confidence in VYJUVEK’s clinical profile. Please note that pricing negotiations in Germany and France are ongoing and progressing well. We expect these negotiations to continue until at least the second half of 2026 in Germany and 2027 in France.

Our colleagues are also achieving early launch successes in Japan after successfully negotiating pricing in October of last year. This includes building a unique in-country distribution model to enable home delivery while addressing the many strict regulation regarding the handling of gene therapies in Japan. Leveraging this infrastructure, our team is driving VYJUVEK adoption and patient treatment in the home setting. Looking ahead to our next launch market, we currently expect to finalize pricing and launch in Italy in the second half of 2026. Italy represents another significant DEB patient population, and we are working diligently to ensure timely access to these patients. Additional pricing negotiations are advancing on schedule in Europe and the UK. I’d like to highlight another important validation of VYJUVEK’s clinical impact.

In December, VYJUVEK was awarded the Prix Galien in France for innovation and clinical impact in the treatment of dystrophic epidermolysis bullosa. This recognition from the French medical and scientific community underscores the transformative nature of VYJUVEK and strengthen our position in ongoing reimbursement discussions across Europe. Looking beyond our direct markets, I’m also pleased to share that we have expanded our distributor network to now include Israel. This expansion demonstrates our commitment to serving DEB patients across various geographies and positions us well for continued growth. While it’s still early in our commercialization journey outside the U.S., we’re seeing the foundation being established for sustainable revenue growth in these markets. The successful pricing negotiations we completed in Japan have been very encouraging and we believe provide a positive benchmark for our ongoing European discussions.

With that, I’ll turn the call over to Suma to share the latest on pipeline development at Krystal.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: Thank you, Laurent, and good morning, everyone. It is my pleasure to share today’s update on our development efforts.... Thanks to the hard work of our dedicated R&D team, we are making rapid progress on our rare disease pipeline, generating breakthrough clinical data and moving quickly towards multiple registrational data readouts later this year. I would like to start by highlighting one such breakthrough recently achieved with our KB-407 program for the treatment of cystic fibrosis. A little over a month ago, we announced a successful delivery and expression of full-length wild-type CFTR protein following KB-407 administration to the lungs of patients with CF. Not only could we confirm full-length protein expression in CF patients with Class one mutations, we also saw that HSV-1 airway cell transduction was consistent across all patients biopsied.

In a diverse patient population, including four modulator-ineligible patients with uncorrected lung disease, we consistently observed transduction rates ranging from 29% to 42%, and all usable biopsies were positive for transduction. Taken together with encouraging apical CFTR expression observed in Class 1 patients, as well as durability of expression out to at least 96 hours, these results give us high conviction in the potential of KB407 to fill the treatment gap that exists today for modulator-ineligible patients. We are working closely with the CFF TDN and the FDA on a repeat dosing study design and streamlined pathways to support registration. We look forward to sharing updates once we have aligned with the agency and expect to start repeat dosing in the first half of the year.

Our KB407 results also have profound implications for our platform, showcasing the versatility of HSV-1-based gene delivery to epithelial tissues beyond the skin. With upcoming readouts for KB801, KB803, and KB408, we hope to further underscore the exciting potential of HSV-1-based gene delivery to both the lung and eye. Another important advantage of our HSV-1 platform is the potential for convenient at-home dosing. Although it took us a few years, we’re very proud that VYJUVEK is now approved in the United States, Europe, and Japan for administration in the home setting, with the option for caregiver or patient administration. This is a fantastic breakthrough for their patients and one we want to secure for as many of our pipeline programs as possible, including our ophthalmology programs, KB801 and KB803. To that end, we have updated the protocol of EMERALD-1, our registrational study evaluating KB801 for the treatment of NK.

Our updated KB801 study protocol is briefly summarized here. To expedite the potential path to registration, we have upsized the study and now expect to enroll approximately 60 patients in the study. To enable flexible administration options from launch, while also mitigating the risk of human error when administering an eye drop, we have updated the KB801 dosing regimen. Patients enrolled in EMERALD-1 will receive KB801 or placebo once daily. Importantly, KB801 or placebo may be administered either by HCP, or by a caregiver, or the patient after receiving appropriate training. We believe that this change will provide maximal flexibility to patients and their caregivers and ultimately support superior real, real-world outcomes. This is also a change that is only made possible by the clean safety profile that we have observed to date across both KB801 and KB803 programs.

We do not expect these changes to meaningfully affect our timelines to data readout. Thanks to the rapid expansion of our clinical trial site network, already over half the number of sites have been activated, and we are well on our way to target 30. We continue to expect data before the end of the year. We have made similar updates to our KB803 program, again, with the goal of maximizing flexibility and real-world outcome for patients from the day of launch. Our KB803 protocol is summarized here. Patients enrolled in the study will receive KB803 or placebo 3 times weekly. As with KB801, KB803 or placebo may be administered either by HCP or by a caregiver or the patient after receiving appropriate training.

With our existing trial network and patients available for rollover from the natural history study, we expect to complete enrollment in the first half and report data before end of the year. We are also making tremendous progress across our broader pipeline, working towards our registrational study start and multiple additional clinical data readouts before year-end.... Our clinical development efforts for KB111, our latest rare skin disease program for the treatment of Hailey-Hailey disease, are progressing well. Our team is in the process of developing our HHD-specific scale and is on track to complete the study in the first half of the year, enabling a registrational study start in the second half. We expect many of our patients from the scale validation study to enroll into the registrational study.

We are actively enrolling patients with AATD lung disease in our KB408 repeat dosing study and expect to be able to issue a data update before year-end. This study includes multiple bronchoscopies, both at baseline and after four-week KB408 doses, and will help us better understand the additive effects of repeat KB408 dosing on lung AAT and bound neutrophil elastase levels. These are key data points that will support accelerated approval discussions with the FDA. We are also enrolling patients on our phase 1 KYANITE-1, evaluating inhaled KB707 in patients with advanced NSCLC. Here as well, we are on track for clinical data updates later this year, with an opportunity to move quickly into a registrational study, having already received FDA input on a phase 3 study design to support a potential filing.

Finally, I would like to make a special mention of the two program designations we recently received from the FDA. In January, the FDA granted us a Fast Track designation for KB111, and earlier this month, we received a RMAT designation for KB707. These designations underscore the potential of our programs to address urgent, unmet needs for patients with rare and serious diseases. They also provide us important advantages to accelerate our programs, including opening the door to accelerated approvals based on surrogate or intermediate endpoints. Having received similar designations for VYJUVEK in the past, we are well-versed in the many benefits they can provide and how to best leverage them. We look forward to working closely with the FDA to accelerate KB111, KB707, and a broader pipeline of redosable genetic medicines. With that, I’ll hand the call over to Kate.

Kate Romano, Chief Accounting Officer, Krystal Biotech: Thank you, Suma, and good morning, everyone. I’ll now provide some highlights from our fourth quarter and full-year financial results reported in our press release and 10-K filing earlier this morning. We previously announced preliminary Q4 2025 VYJUVEK net revenue of $106 million-$107 million. Our final net revenue from global sales of VYJUVEK during the fourth quarter of 2025 was $107.1 million, which includes sales from our Q4 launches in both France and Japan. This marked growth as compared to the prior quarter of almost 10% and approximately 18% growth when compared to the prior year’s fourth quarter. Year-to-date, VYJUVEK net revenue was $389.1 million, an increase of approximately 34% compared to full year 2024 revenue.

Growth to net revenue percentages remain consistent with prior quarters. Cost of goods sold was $6.6 million, compared to $4.3 million in the third quarter and $4.9 million in the prior year’s fourth quarter. Gross margin for the quarter was 94%, as compared to 96% in the third quarter and 95% in the fourth quarter of 2024. This change in gross margin is in part due to the volume of products sold outside of the U.S. increasing, which still carries a higher cost per unit ahead of our planned manufacturing process optimizations for products sold in these markets.

R&D expenses were $14.8 million, compared to $13.5 million in the prior year’s fourth quarter, and SG&A expenses were $41.4 million, compared to $31.3 million in the prior year’s fourth quarter. This increase was primarily due to increased headcount, legal and consulting services, and marketing costs to support our global launches of VYJUVEK. Operating expenses for the quarter included non-cash stock-based compensation of $13.8 million, compared to $13.4 million in the fourth quarter of last year. Consistent with the prior year, we are providing guidance on our non-GAAP operating expenses. For 2026, we anticipate approximately $175-$195 million in non-GAAP R&D and SG&A expenses.

This represents an increase over year-to-date 2025 actual non-GAAP R&D and SG&A expenses of $150.3 million and is the result of our continued planned spend on VYJUVEK global launches and further development of our pipeline. As we discussed in the third quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets. We also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation. This resulted in a one-time, non-cash tax benefit that increased reported EPS for this year. Net income for the quarter was $51.4 million, which represented $1.77 per basic and $1.70 per diluted share.

Net income for the year was $204.8 million, which represented $7.08 per basic and $6.84 per diluted share, reflective of the previously mentioned one-time benefits. Finally, we ended the year with $955.9 million in combined cash and investments, which positions us well to support our commercial launches globally, as well as our upcoming pipeline milestones in the year ahead. Now I will turn the call back over to Krish.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Thanks, Kate. I’d like to reiterate a few key points before we open for questions. First, geographic expansion is a meaningful tailwind for Vyjuvek and for Krystal. There are more DEB patients outside the United States than within it, and we are still early in addressing global demand. In 2026, we’ll continue executing on a disciplined international rollout, and we look forward to adding our third European market, Italy, in the second half of the year. With large identified patient pools, strong demand, and favorable product labels in Europe and Japan, we expect our overseas expansion to be the predominant driver of revenue growth in 2026. In the US, demand continues to grow, but we’re also seeing an evolution in utilization patterns among some longer-tenured patients, shifting toward more intermittent treatment cycles as their disease management stabilizes over time.

Second, as we add patients overseas, it’s important to note that revenue may not track linearly with patient counts this year due to accruals, timing effects, and ongoing pricing negotiations. That said, having completed strong, successful negotiations in Japan, we believe we have a strong value proposition to present to European payers, and we look forward to reaching final alignment on pricing. On the clinical front, we understand the importance of our registrational programs, and we’re executing methodically to drive the desired outcomes. We remain on track to move KB407 into repeat dosing in the months ahead, and we strongly believe the updates to the KB801 and KB803 protocols position these programs to deliver tangible, real-world benefit, maximizing convenience and building resilience to account for the inevitable human factor that comes with self-dosing.

We were also pleased to receive RMAT for KB707 and Fast Track designation for KB111, two designations we know well and that can meaningfully shorten development timelines. We’re excited to advance both of those programs, along with KB408 for alpha-1 deficiency, which is progressing through the redosing phase of the initial study. Overall, 2026 is shaping up to be a busy and an important year, and we’re approaching it with a lot of enthusiasm. With that, let’s open the call for questions.

Conference Operator: Certainly. At this time, we will be conducting a question-and-answer session. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone, to provide optimum sound quality. Please hold while we poll for questions. Your first question for today is coming from Roger Song with Jefferies.

Roger Song, Analyst, Jefferies: Excellent. Thanks, team, for the update and congrats for the successful 2025. A couple questions from us. On Vyjuvek, Krish, I heard you said a couple comments around the U.S. versus ex-U.S. Given two months in the 1Q, any visibility into the 1Q and then, looking ahead at 2026, particularly contribution from ex-U.S. versus U.S. on the dollar value? Because I hear you say the revenue driver predominantly will coming from the ex-U.S. in 2026. Thank you.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Yeah, thanks, Roger. Thanks for the question. I want to clear out a couple of things. While I did say that the predominant growth driver will be from ex-U.S., I do want to highlight that demand in the U.S. is accelerating. I mean, you heard Christine talk about the number of reimbursement approvals being up Q over Q. And the one comment on, while demand in the U.S. is accelerating, you should also assume that patients are now starting to settle into a start-stop regime, which is kind of tough. It’s nuanced, and the kinetics of that is kind of a bit hard to predict. But in Europe, which where the launch is recent, definitely it’s an accelerating growth driver when you think about without exception.

That all said, in terms of breakdown of U.S. versus ex-U.S., we, at the moment, pretty strongly believe that when we report Q1, we will be breaking them out.

Roger Song, Analyst, Jefferies: ... Got it. Yeah, thank you. And then in terms of the pipeline, I just noticing you adjusting the dosing regimen for both ocular and NK be a little bit more frequent. Just curious, any data to support that? I heard you said, yeah, avoid the human error. So any data to suggest more frequent dosing may be resulting in better outcome, and any plan to test less frequent dosing later on? Thank you.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: Yeah, I can take this. I mean, with 801, the weekly dose was deliberate. I mean, obviously, we have seen our blinded data from, you know, and we feel pretty confident about that data. The reason we initially we started with with, you know, in-clinic dosing for 801, and we realized commercially for this to be a viable product, we have to, you know, it has to be home administered. So again, there was, you know, interactions with the agency to get that home dosing. I mean, obviously now it’s implemented. The change was deliberate because now that the dose is being administered by the patient at their home, obviously we train the patients. I mean, there’s always nuances with it, right?

I mean, our concern is you wanna make sure that if, you know, in the, if in the event of daily administration, you know, there’s a dose that they, it, you know, doesn’t get into the eye, they blink, you know, all kind of sort of administration errors. So we thought it’d be easy. We have a very safe profile, and the drug is clean, so we figured, you know, it’s better to avoid. And also it’s, you know, more... It’s easy for the patient to remember, right? Daily, one dose in the morning, you can drop it in the eye. So I think it was deliberate for to make sure that dosing is, you know, they comply, and we get the right dose into the eye.

Roger Song, Analyst, Jefferies: Got it. Yep. Yeah, makes sense. Thank you.

Conference Operator: Your next question is from Sammy Corwin with William Blair.

Sammy Corwin, Analyst, William Blair: Good morning. Thanks for taking my questions. I was curious if you could provide any insight into the compliance rate so far in the EU and Japan. And then, Krish, previously, you’ve commented on, you know, given Krystal’s growing profitability, the company could potentially explore stock buyback options. So I guess I just wonder your updated thoughts there versus increased investment in the pipeline or M&A. Thanks.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Thanks, Sammy. When you talked about compliance, were you referring primarily to the United States compliance number, or was it outside?

Sammy Corwin, Analyst, William Blair: Outside.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Yeah, outside-

Sammy Corwin, Analyst, William Blair: Or in the U.S.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Yeah. Look, in Europe, compliance has been just as compliance has been, had been in the U.S. when we first started the launch. The only comment on Japan I would make is, by law, in Japan, in the first year of launch, the patient has to... The patient only gets a two-week prescription. And so one of the things which is a bit burdensome in the early days of the launch is for the patient to have to go back to the physician to get a new prescription every two weeks. To date, patients have been pretty compliant. It’s the early days of launch, but when you look out over the next six to nine months, one could imagine a situation where some patients may drop off on compliance purely based on this burden.

If there are any such dropouts, our expectation is by the time year two rolls out, which is, late second half of this year, we expect compliance to come back up to normal levels.

Sammy Corwin, Analyst, William Blair: Okay. And for Japan, that two-week prescription burden, you said that lasts for the first year?

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Yeah. Yeah.

Sammy Corwin, Analyst, William Blair: Okay.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: On your second question on profitability and share buyback. Look, we understand we have a few research programs. As you know, our pipeline, we have a few rare diseases that are in registrational and have to launch. We have a couple large indications, one being oncology, one being in alpha-1, one being in aesthetics. And until we kind of have a better sense of how those larger indications are gonna go in terms of having a partner, having some support, either in development or in commercialization, it’s difficult to be very definitive on a timeline for a stock buyback. But that said, one thing I have made clear in the past is we’re not intending presently to use any of our cash towards in-licensing or buying any kind of third-party technology or company at the moment.

Sammy Corwin, Analyst, William Blair: Makes sense. Thank you.

Conference Operator: Your next question is from Alex Stranahan with Bank of America.

Alex Stranahan, Analyst, Bank of America: Hey, guys. Thanks for taking our questions, and congrats on the close to the year. Two questions. Maybe first on XUS. Could you just remind us what’s left on the pricing negotiations and how you expect the balance of price and volumes to trend over the course of this year, into next in France, Germany, and Japan?

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Yeah. I think our present expectation is that we would reach some kind of pricing agreement with Germany in the second half of this year. It’s tough, Alex, at this point to say if it’s a 3Q or a 4Q, but our expectation is sometime in 3Q. With respect to France, clear expectation that we will not reach pricing agreement this year and probably be shifted to sometime in the first half of next year. That’s our present expectation. Japan, we already have a price. The only thing to remember is, in Germany, we will be accruing until the pricing is definite. We’ll also be accruing in France until the pricing becomes definitive.

In general, and I’ve reiterated this in the past, we tend to be a bit conservative when it comes to accruing for a future price.

Alex Stranahan, Analyst, Bank of America: Okay, that makes sense. And then, just maybe on ophthalmology, curious what kinds of updates you can get from these studies at this point, given they’re both actively enrolling. I guess just a bit more on specifically what drove the modified dosing regimens. And, you know, given the protocol amendments, curious, if your comfort with the study powering has changed at all as well, either in NK or DEB. Thank you.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: Yeah. No, as you can see, the powering and the number of patients have not changed because, I mean, we clearly know that, you know, from oxolate and what the effects are. So, you know, it gives us confidence from our data. With regards to, you know, again, 801, we have 50% of our sites. We mean, we are targeting 30 sites, so, you know, we can maximize and optimize... speeding up the process of enrollment. So, with 60 patients, even, you know, on an average of 2 patients per site, we should be good to go. So we have 50% of our sites up and running, and we are aggressively working on getting the other 50, which we should be, you know, I think all of them, done by in the next couple of months.

So I think with all of the sites up to speed, we feel confident in our enrollment as we, you know, as announced that we would enroll the complete enrollment of the study by end of the year. And for 803, and also potentially announce, I mean, you know, it’s 8 weeks, and then we have, you know, hopefully the data all comes in, and we can get data by end of the year. For 803, again, we feel very good from what we saw in our initial blinded study. Again, same thing. Initially, it was designed to do administered by patient, by, you know, clinic, physicians in the clinic, and obviously, we realized that this has to be home administered for the study to be enrolled and patients’ convenience.

So we shifted from, you know, from in-clinic to home dosing. And as a result, again, so the same logic goes beyond. We wanted to make sure that, you know, we know from the data we saw that, you know, give some flexibility for dosing for the patients, because every day can be burdensome. I mean, it can be so they have a volume, and then they can administer the entire volume couple of times a week. So that gives them some flexibility. This is what we learned from VYJUVEK. I mean, there were lessons learned, and that’ll helped us, you know, optimize the dose for 803 in the clinic.

Alex Stranahan, Analyst, Bank of America: Very clear. Thank you. Appreciate the color.

Conference Operator: Your next question for today is from Yigal Nochomovitz with Citigroup.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech2: Hi, thank you very much, and congrats on the progress. I was just curious if you could speak in a little bit more detail with respect to the 90 patients that have been prescribed VYJUVEK in Europe, how that splits out across the geographies, Germany, France, and then also in Japan. And if you could speak to, more specifically, the cadence in terms of patient adds month-over-month in the recent quarter. Thank you.

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Hey, Yigal, thanks for the question. It’s really, it’s really difficult to estimate number of patients in Europe. We do not... I mean, the, the laws are different, between U.S. and Europe, and we’re just making an estimate based on bios being shipped and pharmacies being disclosed. So while it’s a close enough proxy, the number 90 itself is somewhat of an approximation, and to segment that further into France versus Germany versus other countries just makes it that much more irrelevant at the moment. But it provides a directional guidance until we break out revenues. So our expectation is, starting in 1Q, we’ll have an idea, I mean, you will have an idea of how U.S. is doing versus the rest of the world.

But until then, the only reason we provided patient estimates is to give people some sense of how launch is going. And honestly, in all these three countries, given all the different nuances, and Europe is definitely a bit more burdensome in terms of figuring out supply chain logistics, getting the medication to the patient, we feel really good about the way it’s gotten started. Fingers crossed, hopefully, that it continues to go in the right direction.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech2: Okay, understood. And then I was just curious, in Italy, how does the reimbursement work there? I know in Germany you have sort of this three-phase negotiation, and then in France, you accrue from the beginning. What’s the setup in Italy as far as how you do the reimbursement?

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: Italy, we will launch once the pricing is finalized, so we’re not expecting any accrual type situation in Italy.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech2: Okay, thank you.

Conference Operator: Your next question is from Ritu Baral with TD Cowen.

Josh Fleishman, Analyst, TD Cowen: Hey, team. This is Josh Fleishman on the line for Ritu. Congrats on the quarter, and thanks for taking our question. Just curious, was patient compliance also the major factor required to get at-home self-dosing for 803 and ocular DEB? And what was the differentiating factor that resulted in the three times a week dosing schedule for 803 and the once daily dosing schedule for 801?

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: ... Yeah, I mean, I think one of the main deciding factor was obviously home administration. And the reason was, we, as I said, is we learned from VYJUVEK. I mean, from what we see from patient feedback, they have asked that can we administer the drug multiple times during the week, you know? So I think we want to give them the flexibility. So we decided that, yes, let’s have a volume and then give them the flexibility to, you know, administer it as a couple of times during the week. So that was the best, you know, regimen for these patients. Again, based on the data that we saw before, we feel pretty confident that this should not, you know, make any difference. So again, convenience for the patient’s home.

We give them a volume, and they can administer it, that volume during the week.

Josh Fleishman, Analyst, TD Cowen: Okay. Very helpful. Thank you. And then I just have one follow-up, please. On the Italian discussions, we recall that the original guidance for the Italian launch was in mid-2026, now it’s second half. Is the delay associated more with rescheduling, or is it more on pushback than VYJUVEK efficacy?

Krish Krishnan, Chairman and Chief Executive Officer, Krystal Biotech: I would not use the word delay. It’s tough to predict whether it’s in June or whether it’s gonna be in July, but I would not frame that as any kind of delay with respect to the Italian launch. Whatever we said in the past, we continue to believe that’s the timeline.

Josh Fleishman, Analyst, TD Cowen: Okay. Thank you.

Conference Operator: Your next question for today is from Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner, Analyst, Evercore ISI: Hey, guys. Thanks for taking the questions. Also on the ocular modified dosing regimens, what happens to the data generated to date on the prior regimens? Like, does this all get pooled into the primary analysis of the study? And then can I just also confirm, you didn’t change the PFU or the volume of dose in either of the study, right? It’s just the frequency.

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: Correct. No. Yeah. No, none of that changes. The dose is correct. So what happens is, basically when we... The first study goes towards safety, and then we, you know, we started the phase 3 protocol with the SAP. We had to go through back and forth with the agency on the statistical analysis plan. There was a couple of iterations, so this helped us do that too. So it was a combination. Now we have the final protocol, the agreed-upon statistical analysis plan with the agency, which they agree and concurred. All of this is important as we start the study. So it’s all set, and now it’s in the process of execution.

Gavin Clark-Gartner, Analyst, Evercore ISI: Okay. So, like, just to be clear, like, if we just take the NK study for 801, like, all of those 60 patients, those are all gonna be enrolled on a go-forward basis at this modified regimen?

Christine Wilson, Senior Vice President and Head of U.S. Commercial, Krystal Biotech1: Correct. That is correct. Yep.

Gavin Clark-Gartner, Analyst, Evercore ISI: Okay. Really helpful. Thank you.

Conference Operator: Once again, if there are any questions or comments, please press star one on your phone at this time. Thank you. We have reached the end of the question and answer session and today’s conference. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.