Krystal Biotech (NASDAQ:KRYS) reported first-quarter financial results on Monday. The transcript from the company’s first-quarter earnings call has been provided below.
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View the webcast at https://www.webcaster5.com/Webcast/Page/3018/53916.
Summary
Krystal Biotech Inc reported Q1 2026 net revenue of $116.4 million, marking a 9% sequential growth and a 32% year-over-year increase, driven by strong sales of Vyjuvec, particularly in Europe and Japan.
The company maintained a gross margin of 95% and recorded its 11th consecutive quarter of positive EPS, with net income of $55.9 million.
Krystal Biotech Inc highlighted the progress of its pipeline, including two upcoming registrational study readouts expected in 2026 and additional pipeline advancements, particularly in CF and Haley-Haley disease.
The company is actively expanding Vyjuvec’s market presence, planning launches in Italy and Spain in the latter half of 2026, with ongoing pricing negotiations in Germany and France.
Management expressed confidence in their strategic positioning and financial health, supported by a robust cash position exceeding $1 billion, enabling continued pipeline development and market expansion.
Full Transcript
OPERATOR
Thank you for standing by and welcome to the Krystal Biotech Inc first quarter 2026 conference call. this time, all participants have been placed 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, Stephane Paquette, Vice President of Corporate Development. Please begin.
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 first quarter of 2026. The press release is available on our website at www.krystalbio.com. we also filed our earnings 8K and 10Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer Suma Krishnan, President of Research and Development Duran Gooks, Executive Vice President and General Manager for Europe Christine Wilson, Senior Vice President and head of U.S. commercial and Kate Romano, Chief Accounting Officer. This conference call will and our responses to questions may contain forward looking statements. 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 Krish.
Krish Krishnan (Chairman and Chief Executive Officer)
Good morning. It’s now been 10 years since we founded Crystal and in that time we have worked to change the lives of DEB patients globally for the better, while building a durable, fully integrated company with the financial strength to continue delivering value for both patients and shareholders. We have done this with discipline. We’ve not accessed the capital market since 2022. 2022 is six years from when the company was founded. We maintain a strong balance sheet and we continue to generate meaningful operating leverage. Yet more importantly, somewhat ironically, we believe the next 12 to 24 months represent one of the most exciting periods in Crystal’s history. We are positioned for two registrational readouts this year and two more next year. I sincerely want to thank our employees for the dedication and execution that have brought us to this point. Now turning to Vyjuvec, we delivered another quarter of global revenue growth with net revenue of $116.4 million in the queue. This brings cumulative net Vyjuvec revenue since launch to more than $846 million. We are particularly pleased with this performance which represents a 9% sequential growth versus 4Q 2025 despite a higher than usual level of insurance changes, which happens, by the way, not just to us but many biotech commercial companies. In one queue. Gross margin was 95% and we delivered our 11th consecutive quarter of positive EPS outside the U.S. we’re still early in the Vyjuvec launch in Europe and Japan and I’m pleased with the progress overseas. We’re also working to add two additional major European markets, Italy and Spain, later this year. Laurent and Christine will provide more detail on Vysuvec Commercial Dynamics and the opportunity ahead in a moment. FDA has now granted Platform Technology Designations to both KB 407 for CF and KB 111 for Haley Haley. This is in addition to receiving the same designation for Our NK program, KB801 last year. These designations have a profound implications for Crystal at the program level. These designations allow us to streamline our interactions with the agency and our development plans. We’ve already seen the benefits with KB801 as the designation allowed us to rapidly advance KB801 into a registrational study. The platform implications are also powerful. These designations bring a compounding advantage. Each developmental milestone on our pipeline strengthens our collective regulatory data set and reduces development risk, cost and time for the next program we bring to the clinic. This advantage is presently unique to Crystal and one we intend to leverage to its full potential. You’ll hear more about our development plans from Sooma. I’ll now turn it over to the team to provide details on the commercial launch and the clinical pipeline.
Laurent
Laurent thank you Krish. We are very encouraged by the progress we are seeing outside the United States, where Vyjuvec is beginning to establish itself as an important new treatment option for DEB patients in key international markets. When we think about the international launch, the story is not just one of geographic expansion. It is a story of building trust across cultures with physicians, with treatment centers, with payers, and ultimately with the entire EB community who have been waiting for new options. There are nuances in every country we launch, and sometimes within a country by region. That said, across Europe and Japan we are seeing strong word of mouth and increasing engagement from key centers, that is Raising awareness of Vyjuvec and helping translate physician interest into real patient demand. Importantly, our prescriber base continues to broaden. This gives more patients the opportunity to start treatment closer to home while also creating a more durable and resilient foundation for the launch. We estimate that more than 140 DEB patients have been prescribed Vyjuvec across Germany, Japan and France. We believe this reflects both strong execution by our international team and growing physician confidence in Vaijuvec in the early launch market. This early momentum is also beginning to Show Financials European market plus Japan contributed to $28.9 million in net revenue, demonstrating the meaningful role these regions can play in the growth of Vyjuvec over time. Looking ahead, our focus is clear. We are working to deepen penetration in our current launch market, secure positive access and reimbursement outcomes, and expand it to additional major European markets. In Germany and France, pricing negotiations remain ongoing. We continue to expect a decision in Germany in the second half of 2026. In France, we continue to expect a decision in 2027 which would further support broader access and reimbursement stability. We are also advancing discussions with reimbursement authorities in Italy and are actively preparing for potential launch in the second half of 2026 pending the outcome of those negotiations. And in Spain, I’m pleased to report that our discussions with authorities have accelerated. Based on our latest interactions, we now see a potential opportunity to launch in Spain in the second half of the year, again pending the outcome of negotiations. In the interim, we are also responding to opportunities to start patients on Vyjuvec through early reimbursement access pathways. Overall, we are very encouraged by the early tractions we are seeing internationally. The launch is progressing market by market, physician by physician and patient by patient. We remain focused on disciplined execution of our global commercialization strategy and on bringing Vyjuvec to more BEB patients around the world. I will now hand the call off to Christine to share updates on Vijuvec launch in the U.S. christine, thank you Laurent.
Christine Wilson (Senior Vice President and Head of U.S. Commercial)
Our team has been making great progress in recent months, building on our leadership position and delivering transformational outcomes for patients across the United States. Strong salesforce execution is expanding our community reach and allowing us to meet patients wherever they seek care, whether that is at the center of Excellence with a pediatric dermatologist or in a family practice office in the community. By bridging this gap, we have now been able to secure over 695 reimbursement approvals for DEB patients nationwide. Even as access teams were navigating a higher volume of insurance switchovers, upstream demand metrics are even better, with over 60 new prescribers in the first quarter and over 570 unique prescribers since launch, underpinning a strong patient approval outlook for the rest of the year. Net Vyjuvec revenues for the United States were $87.5 million for the quarter. Revenues were impacted by insurance switchovers in the quarter, which are now behind us as well as the start stop treatment cadence characteristics of a patient population shifting towards maintenance treatment regimen. With Vyjuvec now on the market in the United States for nearly three years, a growing number of patients have been able to achieve dramatic and transformational wound closure outcomes. Patients have been able to take control of their disease and their lives, opening up new opportunities and autonomy never before possible. These quality of life gains made possible by the robust efficacy and safety profile of Vyjavac are deeply motivating and the foundation for the long term trust based relationships we are building with the DEB patient community. These improvements are also a natural and anticipated evolution of the launch as patient motivations and support needs shift to reflect their newfound autonomy. This is where the flexibility of Vyjuvec administration and last year’s label updates are especially valuable, providing patients with the option to self administer or receive nurse support where and when they want it. To this end, we have launched patient support initiatives to communicate and educate around recent Vyvac legal updates which provide greater administration flexibility and help DEB patients and their families conveniently integrate Vyjuvec into lifelong wound healing routines as part of their standard of care. Our goal is to establish long term relationships with Vyvac patients, ensuring ongoing connectivity and ease of use throughout throughout their lifelong treatment journey, skin cells do turn over and wounds eventually reopen, particularly as patients get more active. As patients transition into these start and stop phases, we are focused on enabling timely access to Vyjorvec whenever it is needed. This focus is driving continued assessment of our infrastructure to better support patients where they are in their journey and to further enhance the ease of delivering Vyjavec across the United States. At the recent American Academy of Dermatology Conference, key opinion leaders underscored their appreciation for Vyjavec and the positive outcomes achieved by their treated patients in a patient population where prior to Vyjavec’s approval there were no treatment options beyond palliative wound care, Vyjuvec represents a meaningful advancement and fueling an increased focus on the long term clinical and quality of life benefits that that might come with long term Vyjuvec therapy. As we progress in our launch, we are excited about the opportunity ahead. There are still hundreds of known diagnosed patients we hope to bring to therapy and many more not yet identified that we believe could benefit from Vyjuvec. By driving new patient starts and maximizing convenience for patients already on therapy, we see an opportunity to deliver significant growth in the years ahead. With that, I’ll Turn the call over to Suma to share the latest on our development pipeline.
Suma Krishnan (President of Research and Development)
Summa thank you Christine and good morning everyone. I am excited to share that we are faced with two registrational study readouts expected later this year and two more in 2027. With respect to the ophthalmology registrational readouts this year, we are excited to announce the completed enrollment in our registrational study evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients. A total of 16 patients were enrolled in the study. IOLITE study is randomized intra patient double blind decentralized placebo controlled study with crossover design in which patients are randomized one to one to receive KB803 three times weekly for 12 weeks followed by placebo three times weekly for 12 weeks or vice versa. The primary efficacy endpoint, the change from baseline in the average number of days per month with symptoms will be assessed at 24 weeks, putting us on a path for a readout in the fourth quarter of this year. This is an exciting milestone for our team and the many dead patients suffering from ocular complications of this terrible disease. Our second registration study evaluating KB801 for the treatment of neurotropic keratitis is also progressing well. Our focus here is operational, supporting our trial sites, expanding our network and driving enrollment. This is an eight week study. We expect to enroll 60 patients and are on track for a data readout later this year. We are moving quickly on our broader pipeline as well, including the initiation of two open label studies evaluating repeat dose KB407 and KB111 which we expect to read out later this year based on FDA interactions. We are initiating an open label single arm study to evaluate safety of repeat dose KB407 for 24 weeks in 5 patients with CF who are ineligible for, do not tolerate or do not benefit from modular therapy dosing …
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