Krystal Biotech (KRYS) Q4 2025 Earnings Transcript

Image source: The Motley Fool.

Date

Tuesday, Feb. 17, 2026 at 8:30 a.m. ET

Call participants

• Vice President of Corporate Development — Stephane Paquette
• Chairman and Chief Executive Officer — Krish S. Krishnan
• President, Research and Development — Suma M. Krishnan
• Senior Vice President and Head of US Commercial — Christine Wilson
• Senior Vice President and General Manager for Europe — Laurent Goux
• Chief Accounting Officer — Kathryn A. Romano

Need a quote from a Motley Fool analyst? Email pr@fool.com

Takeaways

• Net Product Revenue -- $107.1 million for the quarter, including contribution from Europe and Japan after recent launches.
• Total Net Product Revenue Since Launch -- Over $730 million, with initial overseas markets now contributing.
• Gross Margin -- 94% for the quarter and full year, with management guiding to a 90%-95% gross margin range moving forward.
• Quarterly Revenue Growth Rate -- Approximately 10% sequentially from Q3 2025 and approximately 18% year over year.
• Full Year Net Revenue -- $389.1 million, representing approximately 34% year-over-year growth.
• Cost of Goods Sold -- $6.6 million, up from $4.3 million in Q3 2025 and $4.9 million in Q4 2024, due to increased sales outside the US with higher per-unit costs.
• SG&A Expenses -- $41.4 million in the quarter versus $31.3 million in Q4 2024, attributed to headcount, legal, consulting, and marketing costs for global launches.
• R&D Expenses -- $14.8 million, compared with $13.5 million in Q4 2024, reflecting pipeline advancement.
• Net Income -- $51.4 million for the quarter ($1.77 per basic share, $1.70 per diluted share); $204.8 million for the year ($7.08 per basic share, $6.84 per diluted share), including a one-time noncash tax benefit.
• Cash and Investments -- $955.9 million at period end, with management citing sufficient liquidity for global launches and pipeline milestones.
• Overseas Commercialization -- More than 90 patients prescribed Vyjuvec across Germany, France (via early access), and Japan; ongoing launches in these markets.
• Product Access Expansion -- Distributor agreements now cover over 20 countries, with a target to expand access to over 40 countries by year-end 2026.
• Italian Market Launch -- Management expects to finalize pricing and launch in Italy in the second half of 2026; no revenue accrual before pricing agreement is reached.
• European Reimbursement Status -- Pricing negotiations in Germany expected to conclude in H2 2026, and in France by H1 2027.
• Japan Launch Model -- Japanese regulations require two-week prescriptions during the first year, initially increasing patient burden and affecting compliance.
• US Prescriber Metrics -- Over 50 new prescribers added in the quarter, surpassing 500 unique prescribers since launch, with ongoing demand acceleration.
• Pipeline Readouts -- Multiple registrational data readouts anticipated before year-end 2026; KB407 program demonstrated successful delivery and expression of wild-type CFTR protein in cystic fibrosis patients, with transduction rates of 29%-42% in all biopsied patients.
• Regulatory Designations -- KB111 received FDA Fast Track and KB707 received RMAT designation, both cited as accelerators for development timelines.
• Non-GAAP OpEx Guidance -- Management projects $175 million to $195 million in non-GAAP R&D and SG&A expenses for 2026, exceeding 2025 levels primarily due to commercial expansion and pipeline investment.

Summary

Krystal Biotech (NASDAQ:KRYS) delivered quarterly results marked by expanding international contribution and accelerated US performance, as company leadership emphasized overseas markets as the central revenue driver for the upcoming year. Management reiterated that adverse revenue impacts could occur due to accruals, timing factors, and unfinalized pricing agreements abroad. CFO Kathryn A. Romano highlighted a significant one-time noncash tax benefit increasing reported earnings per share, referencing the release of valuation allowance and a legislative change affecting R&D capitalization. Meanwhile, updates to pipeline study designs introduced flexible, at-home dosing regimens aiming to enhance real-world patient outcomes, as R&D cited ongoing protocol negotiation with the FDA and active efforts to maintain study powering in light of regimen changes. New FDA designations for key pipeline assets may expedite regulatory paths and impact future strategic decisions.

• CEO Krishnan said, "we are 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," signaling current prioritization of internal pipeline development over M&A or external licensing.
• Krishnan indicated that, "the predominant growth driver will be from ex US" in 2026, but acknowledged that US demand "is accelerating" and utilization patterns are shifting toward intermittent use as US patients stabilize.
• For Germany and France, management stated revenue will be accrued conservatively prior to final pricing, potentially reducing quarterly revenue linearity until agreements conclude.
• Pipeline-driven value inflection points may be near, with KB407 moving into a repeat dosing study, while time to pivotal readouts for both KB801 and KB803 remains on track despite regimen modifications.

Industry glossary

• RMAT (Regenerative Medicine Advanced Therapy) designation: An FDA status intended to accelerate development and review of regenerative medicine therapies for unmet medical needs, enabling potential for earlier approval based on surrogate endpoints.
• CFTR: Cystic fibrosis transmembrane conductance regulator, the gene involved in cystic fibrosis targeted for correction by some gene therapies.
• AP2 early access program: A French temporary authorization for use, granting early access to therapies before formal pricing and reimbursement are finalized.

Full Conference Call Transcript

Operator: Thank you for holding. We sincerely appreciate your patience. Please stay on the line, and we will be back in a moment. Thank you for holding.

Operator: We look forward to talking with you soon. Please hold the line, and we will be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we will be right back with you.

Operator: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we will be back in just a moment.

Operator: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we will be back in just a moment.

Operator: Thank you for waiting. Your patience is appreciated. Please hold the line and we will be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we will be right back with you. Thanks for holding.

Operator: We appreciate your time and patience. Please stay on the line, and we will be back in just a moment.

Operator: Thank you for holding. We sincerely appreciate your patience. Please stay on the line, and we will be back in a moment.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we will be right back with you.

Operator: Thank you for holding. We look forward to talking with you soon. Please hold the line, and we will be right back with you.

Operator: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we will be back in just a moment.

Operator: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we will be back in just a moment.

Operator: Thank you for waiting. Your patience is appreciated. Please hold the line and we will be right back with you.

Operator: Thank you for standing by, and welcome to the Krystal Biotech, Inc. 4Q 2025 Conference 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. Good morning, and thank you all for joining today’s call.

Stephane Paquette: Earlier today, we released our financial results for the fourth quarter and full year of 2025.

Stephane Paquette: The press release is available on our website www.crystalbio.com. We also filed our earnings 8-Ks and 10-Ks with the SEC earlier today. Joining me today will be Krish S. Krishnan, chairman and chief executive officer, Suma M. Krishnan, president of research and development, Christine Wilson, senior vice president and head of US commercial, Geraint Goeks, 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.

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 I will turn the call over to Krish. can be found in our SEC filings.

Krish S. Krishnan: With that, thanks, Stefan.

Krish S. Krishnan: 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

Krish S. Krishnan: by the patient is truly innovative. So congrats, Suma.

Krish S. Krishnan: Stepping back,

Krish S. Krishnan: I am very pleased with where we are at Krystal. On the commercial side in 2025,

Krish S. Krishnan: we have made meaningful progress across all geographies. In the US, we added sales capacity and successfully reaccelerated 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 leverage the attributes of Visevac to establish a strong value proposition for patients. And we continue to broaden BIZUVEC access

Krish S. Krishnan: To date,

Krish S. Krishnan: we 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 Vizureka is changing lives remains deeply motivating for our entire team. On the pipeline, we are 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 later this year. Together, that positions us well 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 one trials continue to progress well.

None of this would be possible without the dedication of the Krystal team. And I am grateful for their commitment and execution.

Krish S. Krishnan: Overall,

Krish S. Krishnan: Krystal is building a durable commercial gene therapy company with disciplined capital allocation. We are generating strong gross margins, and operating profitability while expanding global access for Vizurevac. 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 are pleased to report another quarter of revenue growth with net Vysovic revenue of $107,100,000 in Q4. That brings total net Vysoebec revenue since launch to over $730,000,000. 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% to 95% range for the foreseeable future.

Krish S. Krishnan: With that,

Krish S. Krishnan: I will turn it over to Christine to provide an update on the US commercial performance.

Christine Wilson: Thank you, Krish. We remain very encouraged by the VYJOVAC launch and the momentum we are seeing in the US.

Christine Wilson: Which continues to support our long-term commercial outlook. I am pleased to share that we have now seeing reimbursement approval acceleration for three consecutive quarters with over six sixty 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 benefits that Visovac 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 of Vidubic 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 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 Vizurevag launch overseas. Laurent?

Laurent Goux: Thank you, Christine.

Laurent Goux: 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 am proud to report that our global Vidirect launch continues to progress very well. The high patient demand we are seeing across our very different markets validates the transformative impact VYJUVEC brings to the dystrophic epidermolysis bullosa patients and their families. We now estimate that over ninety TED patients have been prescribed by Jureka across Germany, France, and Japan combined.

Laurent Goux: Our long

Laurent Goux: in Germany continues to build momentum since late August of last year. We are sustained prescription growth and good prescribing breadth. The initial centers of excellence are now routinely prescribing VituVec, and we are expanding it to the broader community setting. This geographic distribution is critical for patient access, as it allows the 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 VYJUVEC 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 VITUVEX clinical profile. Please note that pricing negotiations in Germany and France are ongoing and progressing well. We expect this negotiation to continue until at

Laurent Goux: least the 2026 in Germany, and 2027 in France. Our colleagues are also achieving early launch successes in Japan after successfully negotiating pricing in October. This include 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 YJUVEC 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 2026. Italy represent another significant dead 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 would like to highlight another important validation of VITUVEC’s clinical impact. In December, Vajuvac was awarded the Prix Galien in France, for innovation and clinical impact in the treatment of dystrophic bullosa. This recognition from the French medical and scientific community underscores the transformative nature of Vidrovec and strengthen our position in ongoing reimbursement discussions across Europe. Looking beyond our direct markets, I am also pleased to share that we have expanded our distributor network to now include Israel. This expansion demonstrates our commitment to serving the patients across various geographies, and positioned us well for continued growth.

While it is still early in our commercialization journey outside the US, we are 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 will turn the call over to Suma to share the latest on pipeline development at Krystal.

Suma M. Krishnan: Thank you, Loran, 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 lung of patients with CF.

Not only could we confirm full-length protein expression in CF patients, with class one mutations we also saw that HSV1 airway cell transduction was consistent across all patient biopsied. In a diverse patient population, including four modulator ineligible patients,

Suma M. Krishnan: with

Suma M. Krishnan: 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 one patients as well as durability of expression out to at least 96 hours these results give us high conviction the potential of KB407 to fill the treatment gap that exists today for modulator ineligible patients. We are working closely with the CFFTDN and the FDA on a repeat dosing study design and streamline 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 HSV1-based gene delivery to epithelial tissues beyond the skin. Another important advantage of our HSV1 is the potential for convenient at-home dosing. Although it took us a few years, we are very proud that VIGIVEC is now approved in the United States, Europe, and Japan administration in the home setting with the option for caregiver or patient administration. This is a fantastic breakthrough for that patient and one, we want to secure as many of our pipeline programs as possible. Including our ophthalmology program, KB801, and KB803.

To that end, we have updated the protocol of EMERAL one our registrational study, evaluating KB801 for the treatment of NK. Our updated AB801 study protocol is briefly summarized here. To expedite the potential path to registration, we have up ized 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 KB801 dosing regimen. Patients enrolled in EMERALDE one 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-world outcomes. It is also a change that is only made possible that we have observed to date across by the clean safety profile 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. to our KB803 program we have made similar updates again, with goal of maximizing flexibility and real-world outcome for patients from the day of launch. Our KV803 protocol is summarized here. Patients enrolled in the study will receive KV803 or placebo three times weekly. As with KV801, KB803, all 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 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 Hiri 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 illicit 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 1/2 KYNITE1 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

Suma M. Krishnan: These designations underscore the potential of our programs a RMAT designation for KD707.

Suma M. Krishnan: to address urgent unmet needs for patients with rare and serious diseases. We also provide important advantages to accelerate our program including opening the door to accelerated approval, based on surrogate or intermediate endpoints. Having received similar designations for Vigevac 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 will hand the call over to Kate. Thank you, Suma, and good morning, everyone.

I will now provide some highlights from our fourth quarter and full year financial results reported in our press release and 10-Ks filing earlier this morning. We previously announced preliminary Q4 2025 Vigebeck net revenue of $106,000,000 to $107,000,000. Our final net revenue from global sales of VYJEVEC during the 2025 was $107,100,000 which includes sales from our Q4 launches in both France and Japan.

Kathryn A. Romano: 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, Vigevec net revenue was $389,100,000, 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 $6,600,000 compared to $4,300,000 in the third quarter and $4,900,000 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 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. were $14,800,000 R&D expenses compared to $13,500,000 in the prior year’s fourth quarter and SG&A expenses were $41,400,000 compared to $31,300,000 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 Vigebec. Operating expenses for the quarter included noncash stock-based compensation of $13,800,000 compared to $13,400,000 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 $175,000,000 to $195,000,000 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 $150,300,000 and is the result of our continued planned spend on VYJEVAP global launches and further development of our pipeline.

Kathryn A. Romano: As we discussed in the third quarter,

Kathryn A. Romano: 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 onetime noncash tax benefit that increased reported EPS for this year.

Kathryn A. Romano: Net income for the quarter was $51,400,000 which represented $1.77 per basic and $1.70 per diluted share.

Kathryn A. Romano: Net income for the year was $204,800,000 which represented $7.08 per basic and $6.84 per diluted share, reflective of the previously mentioned onetime benefits. And finally, we ended the year with $955,900,000 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.

Stephane Paquette: Thanks, Kate. And now I will turn the call back over to Krish. I would like to reiterate a few key points before we open for questions. First, geographic expansion is a meaningful tailwind for Vizureka and for Krystal.

Krish S. Krishnan: There are more DEP patients outside the United States than within it, and we are still early in addressing global demand. In 2026, we will continue 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 are 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 is 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 are 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 are excited to advance both of those programs along with KB408 for alpha one deficiency which is progressing through the redosing phase of the initial study.

Krish S. Krishnan: Overall,

Krish S. Krishnan: 2026 is shaping up to be a busy and an important year and we are approaching it with a lot of enthusiasm. But that let us open the call for questions.

Operator: Certainly. At this time, we will be conducting a question and session. If you have any questions or comments, please press 1 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.

Operator: Your first question for today is coming from Roger Song with Jefferies. Excellent.

Roger Song: Thanks, team, for the update, and congrats for the successful 2025. A couple of questions from us. On VEGIVAC, I heard you said a couple comments around the US versus the US. Given two months in the 1Q, any visibility into the 1Q and then looking ahead of 2026, particularly contribution

Roger Song: from ex US versus US on dollar value? Because I hear you say the revenue driver predominantly will come from the ex US in 2026. Thank you.

Krish S. Krishnan: Yeah. Thanks, Roger. Thanks for the question. I want to clear out a couple things. While I did say that the predominant growth driver will be from ex US, I do want to highlight that demand in the US is accelerating. 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 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 is nuanced, the kinetics of that is kind of a bit hard to predict.

But in Europe, which, for the launch is recent, definitely, it is 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 1Q, we will be breaking them out.

Roger Song: 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 I heard you said that yeah, avoid that human error. So any data to suggest more frequent dosing may be resulting better outcome and any plan to test less frequent dosing later on? Thank you.

Suma M. Krishnan: Yeah, I can take this. I mean, with 801, 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 with initially we started the talk 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 is implemented. The change was deliberate because now that the dose is being administered by the patient at their home, obviously, train the patient.

I mean, there is always nuances with it. Right? I mean, our concern is you want to make sure that, you know, in the in the event of daily administration, you know, there is a dose that they you know, does not get into the eye. They blink. You know, all kind of sort of administration errors. So we thought it would be easy. We have a very safe profile. And the drug is clean. So we figured, you know, it is better to avoid and also you know, more it is easy for the patient to remember. Right? Daily one dose in the morning, you can drop it in the eye.

I think it was deliberate for to make sure that dosing is know they comply and we get the right dose in AI. Got it. Yep. Yeah. Makes sense. Thank you. Your next question is from Sami Corwin with William Blair. Good morning. Thanks for taking my questions.

Samantha Danielle Corwin: I was curious if you could provide any insight into the compliance rate so far in the EU and Japan. And then, Chris, previously, you have commented on giving Krystal’s growing profitability the company could potentially explore. Stock buyback options. So I guess I just wanted your updated thoughts there versus increased investment in the pipeline or M&A?

Samantha Danielle Corwin: Thanks.

Samantha Danielle Corwin: Thanks, Tammy.

Krish S. Krishnan: When you when you talked about compliance, were you referring primarily to the United States compliance number, or was it outside? Outside. Outside. In the US. Yeah. Look. In Europe, compliance has been just as compliance has been 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 two weeks.

Today, patients have been pretty compliant. It is 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 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.

Samantha Danielle Corwin: Okay. And for Japan, that

Samantha Danielle Corwin: two week prescription burden, you said that lasts for the first year? Yep.

Krish S. Krishnan: Yeah. Okay. And on your second question on profitability and share buyback,

Krish S. Krishnan: look,

Krish S. Krishnan: we understand we have a few research programs 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 an alpha one, 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 is 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 are 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.

Samantha Danielle Corwin: Makes sense. Thank you.

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

Alec Stranahan: Questions, and congrats on the close to the year. Two questions. Maybe first on ex US. Could you just remind us what is 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.

Krish S. Krishnan: I think our present expectation is that we would have reach some kind of pricing agreement with Germany in the second half of this year. It is tough, Alec, at this point to say if it is a 3Q or a 4Q, but our expectation is sometime in March. With respect to France, clear expectation that we will not reach pricing agreement this year and probably be shipped shifted to sometime in the first half of next year. That is 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 will also be accruing in France until the pricing becomes definitive.

And in general, and I have reiterated this in the past, we tend to be a bit conservative when it comes to accruing. For a future price.

Alec Stranahan: 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 are 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 an NK or DDEB. You.

Suma M. Krishnan: 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 oxalate and what the effects is. So know, give us confidence on from our data. With regards to you know, again, 801, we have 50% of our sites. We mean we are targeting 30 sites. You know, we can maximize and optimize speeding up the process of enrollment. So with 60 patients even, you know, on 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

Samantha Danielle Corwin: 50, which we should be, you know, I think

Suma M. Krishnan: all of them done by in the next couple of months. 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 study by end of the year. And for 08/2003,

Samantha Danielle Corwin: and also potentially announced, I mean, you know, it is eight weeks and then

Suma M. Krishnan: we have

Kathryn A. Romano: know,

Samantha Danielle Corwin: hopefully, the data all comes in and we can get data by end of the year. For 08/2003, 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 for the study to be enrolled in patient’s convenience. So we shifted from, you know, from in clinic to home dosing.

And as a result, again, for the same logic goes beyond, we wanted to make sure that you know, we know from the data we saw that you know, 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 us some flexibility. This is what we learned from. I mean, there were lessons learned, and that will helped us, you know, optimize the dose for 803 in the clinic. Very clear. Thank you. Appreciate the color. Your next question for today is from Ygal Nochomovitz with

Operator: Citigroup.

Yigal Dov Nochomovitz: 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 VIGIVIC in Europe, how that splits out across the

Yigal Dov Nochomovitz: geographies, Germany, France, and then also in Japan. If you could speak to, just more specifically, the cadence in terms of patient adds month over month in the recent quarter? Thank you.

Yigal Dov Nochomovitz: Hey, Gal.

Krish S. Krishnan: Thanks for the question. It is really it is really difficult to estimate number of patients in Europe. We do not I mean, they the laws are different. Between US and Europe and more just making an estimate based on vials being shared then. Pharmacies being disclosed. So while it is a close enough proxy, the number 90 itself is somewhat of an approximation, segment that further into France versus Germany versus other countries just makes it that much more irrelevant at the moment.

Samantha Danielle Corwin: But

Krish S. Krishnan: it provides a directional guidance until we break out revenues. So our expectation is

Yigal Dov Nochomovitz: starting in January, we will have an idea

Krish S. Krishnan: mean, you will have an idea of how 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 how some sense of how launch is going. And, honestly, in all these three countries, given all the different nuances, 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 has gotten started. Fingers crossed, hopefully. That it continues to go in the right direction.

Yigal Dov Nochomovitz: Okay. Understood. And then I was just curious in Italy, how does the reimbursement work there? I know in Germany, have sort of this three phase negotiation. And then in France, you accrue from the beginning. What is the setup in Italy as far as how you do the reimbursement?

Krish S. Krishnan: Italy, we will launch once the pricing is finalized. So we are not expecting any accrual type situation in Italy.

Yigal Dov Nochomovitz: Okay. Thank you.

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

Joshua Seth Fleishman: Hey team, this is Josh Beishman on the line

Joshua Seth Fleishman: 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 three times a week dosing schedule for 803 and the once daily dosing schedule for 801.

Suma M. Krishnan: 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 learn from. 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 want to give them the flexibility. So we decided that yet let us have a volume and then give them the flexibility to you know, administer it as couple of times during the week. 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, 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.

Joshua Seth Fleishman: Okay. Very helpful.

Joshua Seth Fleishman: 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 is second half. Is the delay associated more with rescheduling? Or is it more on pushback than VITIVEX efficacy?

Krish S. Krishnan: This is that I would not use the word delay. It is tough to predict. Whether it is in June or whether it is 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 is the timeline. Thank you.

Operator: Okay. Your next question for today is from Gavin Clark.

Operator: Gartner. With Evercore ISI.

Gavin Clark-Gartner: 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 did not change the PFU or the volume of dose in either of the study? Right? It is 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,

Suma M. Krishnan: 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. It is 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 is all set, and now it is in the in the process of execution.

Gavin Clark-Gartner: Okay. So, like, just to be clear, like, if we just take the NK study? For, 08/2001, like, all of those 60 patients, those are all going to be enrolled on a go forward basis at this modified regimen. Correct.

Suma M. Krishnan: That is correct. Yep.

Gavin Clark-Gartner: Okay.

Gavin Clark-Gartner: Really helpful. Thank you.

Operator: Once again, if there are any questions or comments, please press 1 on your phone at this time.

Operator: Thank you.

Operator: 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.

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool has positions in and recommends Krystal Biotech. The Motley Fool has a disclosure policy.