Krystal Biotech Reports Q4 Revenue of $107.1M, Expands International Presence

Krystal Biotech reported fourth-quarter 2025 net revenue from Vyjuvek of $107.1 million, extending 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 posted earnings per share of $1.70 for the fourth quarter of 2025, exceeding the consensus estimate of $1.62 and marking an increase from $1.52 in the same period last year. Revenue for the quarter reached $107.1 million, reflecting a 17.5% year-over-year growth, though this figure fell short of the expected $109 million. All revenue was generated from sales of Vyjuvek, the company's sole commercial product.

Q4 revenue rose by nearly 10% sequentially and about 18% year over year. Full-year 2025 net Vyjuvek revenue totaled $389.1 million, up approximately 34% from 2024. Vyjuvek sales totaled $107.1 million in Q4, up from $91.1 million in the previous year, driven by strong patient adoption.

Gross margin stood at 94% for the quarter and 94% for the full year, with management reiterating expectations for margins in the 90% to 95% range for the foreseeable future. The slight decline from the prior quarter was attributed to a higher mix of product sold outside the U.S., where the company is currently seeing higher cost per unit ahead of planned manufacturing process optimizations for those markets.

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). The 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.

Research and development expenses, including stock-based compensation, amounted to $14.8 million, representing a 9.36% increase year over year, compared with $13.5 million in Q4 2024. Selling, general, and administrative expenses reached $41.4 million, up 32.5% from the prior year, largely due to expanded staffing, legal and consulting fees, and marketing efforts supporting Vyjuvek's global rollout. For 2026, Krystal Biotech 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.

By December 31, 2025, Krystal Biotech held $955.9 million in cash, equivalents, and investments, compared to $864.2 million at the end of September 2025.

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, citing an expanded sales force that is now fully trained and deployed. Patients are seeing durable wound closure, which in many cases allows them to shift to as-needed use over time.

Management 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, a "nuanced" shift among some longer-tenured U.S. patients toward more intermittent "start-stop" treatment cycles as disease management stabilizes was noted. The company expects to begin breaking out U.S. versus ex-U.S. revenue when it reports first-quarter results.

Krystal estimates that more than 90 DEB patients have been prescribed Vyjuvek across Germany, France, and Japan combined. Growing prescription breadth in Germany since the late-August 2025 launch was described, with expansion beyond initial centers of excellence into broader community settings to improve access and reduce the burden on treatment centers. After initiation in a center, most of the patients are already benefiting from home administration.

In France, Vyjuvek is launching under the AP2 early access program, which is operating as designed while negotiations with French health authorities continue. 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, the company completed pricing negotiations in October 2025 and built a distribution model to support home delivery while meeting strict gene therapy handling regulations. A legal requirement in Japan limits prescriptions to two weeks during the first year after launch, which could create compliance burdens; compliance is expected to normalize in the second year, beginning in the latter half of 2026.

Management said it expects to finalize pricing and launch in Italy in the second half of 2026, adding a third European market. Unlike Germany and France, Italy is expected to launch only after pricing is finalized. Distributor agreements now cover over 20 countries, with a target to expand access to over 40 countries by year-end 2026.

Vyjuvek pricing discussions with reimbursement agencies in Germany and France are ongoing and expected to continue into late 2026 and 2027.

The company is advancing several investigational genetic therapies across respiratory, oncology, dermatology, ophthalmology, and aesthetics. Multiple registrational data readouts are anticipated before year-end 2026.

The respiratory pipeline includes KB407 (for cystic fibrosis) and KB408 (for alpha-1 antitrypsin deficiency). KB407 demonstrated successful lung delivery and CFTR protein expression in recent clinical data, with transduction rates of 29%-42% in all biopsied patients. A pivotal study is planned for early 2026. KB408 is in ongoing enrollment, with interim results anticipated in 2026.

Ophthalmology candidates include KB803 (for corneal abrasions in DEB patients) and KB801 (for neurotrophic keratitis), both in active clinical trials with results expected in 2026.

KB111 received FDA Fast Track Designation for the treatment of HHD in January. Oncology candidate KB707, targeting solid lung tumors, was granted RMAT designation by the FDA in February. Patient enrollment is underway in the KYANITE-1 study, evaluating KB707 alone and with chemotherapy. Both designations were cited as accelerators for development timelines.

Jeune Aesthetics, a subsidiary, is developing KB304 for décolleté wrinkles, with a mid-stage study planned for 2027.

Leadership indicated that the company is not intending presently to use any of its cash towards in-licensing or buying any kind of third party technology or company at the moment, signaling current prioritization of internal pipeline development.