Krystal Biotech Inc (KRYS) 2025 Q4 法說會逐字稿

Thank you for holding. We look forward to talking with you soon. Please hold the line and we'll be right back with you.

Thank you for standing by and welcome to the Krystal Biotech 4Q 2025 conference call. (Operator Instructions) As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Vice President of Corporate Development.

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.crystalbio.com.

We also filed our earnings 8-K and 10-K with the SEC earlier today. Joining me today will be Kirsh Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Christine Wilson, Senior Vice President and Head of US Commercial; Laurent Goux, 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 will turn the call over to Chris.

Thanks, Stephane. 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, it's 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 US we added sales capacity and successfully re-accelerated demand.

In Europe, despite the country by country nuances, we launched a generic medicine that can be applied in a home setting by a patient.

In Japan, we leverage the attributes of VYJUVEK to establish a strong value proposition for patients.

And we continue to broaden VYJUVEK access globally.

To date, they signed distributive 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 deaf patients, With the potential to initiate two additional registrational programs in CF and [Haley Haley] 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 the commitment and execution. Overall, Krystal's 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 revenues 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 we'll 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% to 95% range for the foreseeable future. With that, I'll turn it over to Christine to provide an update on the US commercial performance.

Thank you, Krish. We remain very encouraged by the VYJUVEK launch and the momentum we are seeing in the US, 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 [DDAB] 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 deaf 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.

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 redirect launch continues to progress very well.

The high patient demand we're seeing across our very different markets validates the transformative impact that VYJUVEK brings to the dystrophic epidermises below our patients and their families. We now estimate that over 90 dead patients have been prescribed by 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 by VYJUVEK, and we are expanding it to the broader community setting.

This geographic distribution is critical for patient access as it allows dead 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 AP 2 Early Access Program. The AP2 program is functioning exactly as designed, providing eligible patients 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 regulations 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 dead patient population, and we're 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 Gallien] in France for innovation and clinical impact in the treatment of dystrophic [epidemiosis biosa].

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 dead patients across various geographies and positions us well for continued growth. While it's still early in our commercialization journey outside the US, 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 without I'll turn the call over to Suma to share the latest on pipeline development at Krystal.

Thank you, Lauren, 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 KB407 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 KB407 administration to the lungs of patients with CF. Not only could we confirm full length protein expression in CF patients with Class 1 mutations, we also saw that HSV1 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 GAAP that exists today for modulator ineligible patients.

We are working closely with the CFFTDN 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.

RKB407 results also have profound implications for our platform, showcasing the versatility of HSV1 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 HSV1 based gene delivery to both the lung and eye.

Another important advantage of our HSV1 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 that 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 [EIL1], 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. And to enable flexible administration options from launch, while also mitigating the risk of human error when administrating an eye drop, we have updated the KB 801 dosing regimen.

Patients enrolled in Emerald I will receive KB 801 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 maximum flexibility to patients and their caregivers and ultimately support superior real world outcomes. It 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 date readout. Thanks to the rapid expansion of our clinical trial site network, already over 50 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, the goal of maximizing flexibility and real world outcome for patients from the day of launch.

RKB 803 protocol is summarized here. Patients enrolled in the study will receive KB803, all 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 1st half and report data before the end of the year. We are also making tremendous progress across a 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 full 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're also enrolling patients on our Phase1 to [kite 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 an [RAt] 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 redo sable genetic medicines. With that, I'll hand the call over to Kate.

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 4Q 2025 VYJUVEK net revenue of $106 million to $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 4th quarter. Year-to-date, VYJUVEK net revenue was $389.1 million an increase of approximately 34% compared to full year 2024 revenue.

Gross 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 US 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 million to $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.

And 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. And now I will turn the call back over to Krish.

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 dead 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 KB 801 and KB 803 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 [RAT] 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 re-dosing 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.

(Operator Instructions) Roger Song, Jefferies.

Excellent, thanks team for the update and congrats for the successful 2025. A couple questions from us on [eggac], question, I heard you said a couple, comments around the US versus US, given two months in the one queue, any, visibility into the one queue and then. Looking ahead of 2026, particularly contribution, from ex US versus US on the dollar value, because I hear you say the revenue driver predominantly will come from the ex US in 2026.

Thank you.

Yeah, thanks, Roger. Thanks for the question. I want to clear out a couple of things. Well, I did say that the predominant growth driver will be from exUS, I do want to highlight that demand in the US is accelerating. I mean, you heard Christine talk about the number of reimbursement approvals being up queue over queue.

And the one comment on while demand in the US 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 US versus ex US, we at the moment. Pretty strongly believe that when we report one cube, we will be breaking them up.

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, avoid the human error. So any data to suggest, more frequent dosing maybe, resulting in better outcome and any plan to test less frequent dosing later on. Thank you.

Yeah, I can take this. I mean, with 801, the weekly dose was deliberate. I mean, obviously, we have seen our blinded data from, and, we feel pretty confident about that data. The reason we initially we started with her with, in clinic dosing for 801. And we realized commercially for this to be a viable product, we have to, it has to be home administered. So again, there was, 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 train the patients. I mean, there's always no answers with it, right? I mean, our concern is you want to make sure that you, in the event of daily administration. And there's a dose that they, it doesn't get into the eye, they blink, 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, it's better to avoid and also it's, 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, they comply and we get the right dose in the eye.

Got it. Yeah, makes sense. Thank You.

Sami Corwin, William Blair.

Good morning. Thanks for taking my questions. I was curious if you could provide any insight into the compliance rates so far in the EU and Japan. And then Chris previously commented on, giving Krystal's growing profitability. The company could potentially explore stock buyback options. So I guess I just want your updated thoughts there versus increased investment in the pipeline or M&A. Thanks.

Thanks, Sammy. When you talked about compliance, were you referring primarily to the United States compliance number, or was it, outside.

Outside, a couple things, a couple in the US.

Yeah, look, in Europe, compliance has been, Just as compliance has had been in the US 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 2 weeks.

To date, patients have been pretty compliant. It's the early days of launch, but when you look out over the next 6 to 9 months, one could imagine a situation where some patients may drop off on compliance purely based on this burden.

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

Okay, and for Japan, that, two week prescription burden you said that lasts for the first year.

Yeah, and On your second question on profitability and share buyback. Look, We understand, we have a few research programs, as our pipeline. We have a few rare diseases that are in registrational and have to launch. We have a couple of large indications, one being oncology, one being an Alpha 11 being an aesthetics. And until we kind of have a better sense of how those larger indications are going to 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.

Makes sense, thank you.

Alec Stranahan, 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.

Yeah, I think our present expectation is that we would have, reached some kind of pricing agreement with Germany in the second half of this year. It's tough, Alec, 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. And 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.

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, 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.

Yeah, no, as you can see, the powering and the number of patients have not changed because, I mean, we clearly know that, from the weight and what the effects size, so, gives us confidence from our data, with regards to, again, 801, we have 50% of our sites. I mean, we're targeting 30 sites, so, we can maximize and optimize, speeding up the process of enrollment.

So, with 60 patients, even, on an average of two 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, I think all of them are done by in the next couple of months. So, I think with all of those sites up to speed, we feel confident in our enrollment as we, as announced that we would enroll this complete enrollment of the study by the end of the year.

And for 803 and also potentially announced, I mean, it's eight weeks and then we have, hopefully the data all comes in and we can get data by the 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 a. Administered by patient by, clinic clinicians in the clinic and obviously we realized that this has to be home administered for the study to be enrolled in patients' convenience so we shifted from in clinic to home dosing and as a result again all the same logic goes beyond we wanted to make sure that, we know from the data we saw that, 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 a couple of times a week so that gives them some flex flexibility. This is what we learned from Bubac. I mean there were lessons learned and that'll helped us, optimize the dose for 803 in the clinic.

Very clear thank you appreciate the color.

Yigal Nochomovitz, Citigroup.

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 ads, month over month in the recent, quarter. Thank you.

Thanks Yigal. Thanks for the question. It's really difficult to estimate the number of patients in Europe. We do not, I mean, the laws are different, between US and Europe, and we're just making an estimate based on vials 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 one queue, we'll have an idea. I mean, you will have an idea of how the US is doing versus the rest of the world, but until then, the only reason we provided patient estimates is to give people a sense of 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.

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 3 Phase negotiation, and then in France you accrue from the beginning. What, what's the setup in Italy as far as how you do the reimbursement?

Italy, we will launch once the pricing is finalized, so we're not expecting any accrual type situation in Italy.

Okay, thank you.

Ritu Baral, TD Cowen.

Hey team, this is Josh Fleischman on the line for 2. 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 KB801?

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 Week. I mean, from what we see from patient feedback, they have asked that can be administered the drug multiple times during the week, 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, administer it as a couple of times during the week. So that was the best, regimen for these patients. Again, based on the data that we saw before, we feel pretty confident that this should not, 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.

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's efficacy?

This is that I would not use the word delay. It's tough to predict. Whether it's in June or whether it's going to 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.

Okay.

Thank you.

Gavin Clark-Gartner, 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 pulled 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, 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, wear the Phase 3, protocol with the SAP, we had to go through back and forth with the agency on the statistics. 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 in the process of execution.

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 going to be enrolled on a go forward basis at this modified regimen.

Correct. That is correct. Yes.

Okay really helpful. Thank you.

(Operator Instructions) .

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.