Krystal Biotech (NASDAQ:KRYS) reported fourth-quarter 2025 net revenue from VYJUVEK of $107.1 million, extending what management described as continued launch momentum in the U.S. and early traction in Europe and Japan. Total net VYJUVEK revenue since launch has now surpassed $730 million, the company said on its Q4 2025 earnings call.
VYJUVEK sales growth and profitability
Chief Executive Officer Krish Krishnan said the quarter’s net revenue included contributions from Europe and Japan as the company “build[s] momentum” in its initial overseas markets. Chief Accounting Officer Kate Romano said Q4 revenue rose by nearly 10% sequentially and about 18% year over year, while full-year 2025 net VYJUVEK revenue totaled $389.1 million, up approximately 34% from 2024.
On expenses, Romano reported R&D of $14.8 million versus $13.5 million a year earlier, and SG&A of $41.4 million versus $31.3 million, driven primarily by increased headcount and higher legal, consulting, and marketing costs tied to global launches. For 2026, Krystal guided to non-GAAP R&D and SG&A expenses of approximately $175 million to $195 million, up from 2025 actual non-GAAP operating expenses of $150.3 million.
Net income was $51.4 million for the quarter ($1.77 per basic share and $1.70 per diluted share) and $204.8 million for the year ($7.08 basic and $6.84 diluted). Romano said 2025 EPS reflected one-time, non-cash tax benefits tied to releasing a valuation allowance against deferred tax assets and the reversal of Section 174 R&D capitalization requirements under the “One Big Beautiful Bill” legislation.
Krystal ended 2025 with $955.9 million in combined cash and investments, management said.
U.S. demand trends and evolving utilization
Christine Wilson, head of U.S. commercial, said the company has now recorded “reimbursement approval acceleration for three consecutive quarters,” reaching more than 660 reimbursement approvals since launch. Krystal added more than 50 new prescribers in Q4 and has surpassed 500 unique prescribers since launch, Wilson said, citing an expanded sales force that is now fully trained and deployed.
Wilson also highlighted broader patient identification, including patients with dominant dystrophic epidermolysis bullosa (DDEB) treated by local dermatologists and primary care physicians. She said patients are seeing durable wound closure, which in many cases allows them to shift to as-needed use over time.
In Q&A, Krishnan emphasized that while the company expects overseas markets to be the predominant driver of revenue growth in 2026, it is also seeing accelerating U.S. demand. At the same time, he noted a “nuanced” shift among some longer-tenured U.S. patients toward more intermittent “start-stop” treatment cycles as disease management stabilizes.
Krishnan said the company expects to begin breaking out U.S. versus ex-U.S. revenue when it reports first-quarter results.
Europe and Japan launch update and pricing negotiations
Laurent Goux, general manager for Europe, said Krystal estimates that more than 90 DEB patients have been prescribed VYJUVEK across Germany, France, and Japan combined. He described growing prescription breadth in Germany since the late-August 2025 launch, with expansion beyond initial centers of excellence into broader community settings to improve access and reduce the burden on treatment centers. Goux added that after initiation in a center, “most of the patients are already benefiting from home administration.”
In France, Goux said VYJUVEK is launching under the AP2 early access program, which he said is operating as designed while negotiations with French health authorities continue. He also said pricing negotiations in Germany and France are ongoing and “progressing well,” with expectations that negotiations could continue until at least the second half of 2026 in Germany and 2027 in France.
In Japan, Goux said the company completed pricing negotiations in October 2025 and built a distribution model to support home delivery while meeting strict gene therapy handling regulations. In Q&A, management said a legal requirement in Japan limits prescriptions to two weeks during the first year after launch, which could create compliance burdens; management expects compliance to normalize in the second year, beginning in the latter half of 2026.
Looking ahead, management said it expects to finalize pricing and launch in Italy in the second half of 2026, adding a third European market. Krishnan noted that, unlike Germany and France, Italy is expected to launch only after pricing is finalized, meaning Krystal does not anticipate an accrual model there.
Krishnan also cautioned that ex-U.S. revenue may not track linearly with patient counts due to accruals, timing effects, and ongoing pricing negotiations. He said Krystal tends to be conservative in its pricing accrual assumptions.
Goux highlighted external recognition in France, noting that VYJUVEK received the Prix Galien award in December for innovation and clinical impact in DEB. He also said Krystal expanded its distributor network to include Israel and has distributor agreements covering more than 20 countries, with a goal to exceed 40 countries in 2026.
Pipeline: registrational studies, protocol changes, and FDA designations
President of R&D Suma Krishnan said the company is advancing multiple programs with several registrational readouts expected before year-end. She highlighted KB407 in cystic fibrosis, stating Krystal recently confirmed delivery and expression of full-length, wild-type CFTR protein in lung tissue after administration. She said biopsies showed HSV-1 airway cell transduction consistency across patients, with reported transduction rates ranging from 29% to 42% in biopsied patients and durability of expression out to at least 96 hours. Krystal said it is working with the Cystic Fibrosis Foundation Therapeutics Development Network and the FDA on a repeat-dosing study design and expects to start repeat dosing in the first half of the year.
For ophthalmology, Krishnan detailed protocol updates to registrational programs KB801 (neurotrophic keratitis) and KB803 (treating eye lesions in DEB) aimed at supporting flexible at-home administration. Key updates discussed on the call included:
- KB801 (EMERALD-1): Study increased to approximately 60 patients; dosing changed to once daily KB801 or placebo, with administration allowed by an HCP, caregiver, or patient after training. The company said it does not expect these changes to materially affect timelines and continues to expect data before year-end.
- KB803: Dosing set at three times weekly KB803 or placebo, with the same trained administration options. Krystal expects enrollment completion in the first half and data before year-end.
Management said the dosing changes were driven by the need to enable home administration and reduce the impact of potential administration errors, citing a clean safety profile observed across KB801 and KB803. Executives also said neither the dose strength nor volume changed—only dosing frequency—and that patients in the 60-patient NK study will be enrolled under the updated regimen going forward.
Elsewhere in the pipeline, Krystal said KB111 (Hailey-Hailey disease) is progressing, with an HHD-specific scale validation study expected to complete in the first half of the year to support a registrational study start in the second half. The company is enrolling patients in a KB408 repeat-dosing study for alpha-1 antitrypsin deficiency lung disease, with an update expected before year-end, and is enrolling patients in KYANITE-1, a phase I study of inhaled KB707 in advanced non-small cell lung cancer, with clinical updates expected later this year.
Krystal also said the FDA granted Fast Track designation for KB111 in January and RMAT designation for KB707 earlier in the month, which management said could help accelerate development and potentially support accelerated approval paths based on surrogate or intermediate endpoints.
Capital allocation and buyback commentary
Asked about potential share repurchases, Krishnan said it is difficult to provide a timeline given the company’s larger-indication programs (including oncology, alpha-1, and aesthetics) and the possibility of partnering for development or commercialization support. However, he reiterated that Krystal is not currently intending to use its cash for in-licensing or acquiring third-party technology or companies.
About Krystal Biotech (NASDAQ:KRYS)
Krystal Biotech, Inc is a clinical-stage biotechnology company focused on developing gene therapies for rare dermatological diseases. Headquartered in Pittsburgh, Pennsylvania, the company applies proprietary viral vector delivery technology to enable topical administration of corrective genes directly to the skin. By targeting the underlying genetic causes of inherited skin disorders, Krystal Biotech seeks to address areas of high unmet medical need with potentially transformative treatments.
The company’s lead product candidate, KB103, is designed to deliver a functional COL7A1 gene to patients with dystrophic epidermolysis bullosa (DEB), a severe and often debilitating blistering condition.
