Krystal Biotech (NASDAQ:KRYS) reported second-quarter 2026 net revenue of $119.2 million from global sales of VYJUVEK, up 24% from $96 million in the prior-year period, as the company expanded treatment access for patients with dystrophic epidermolysis bullosa, or DEB, in the United States and overseas.
Net income rose to $54.8 million, or $1.79 per diluted share, from $38.3 million, or $1.29 per diluted share, a year earlier. The company ended the quarter with more than $1.1 billion in cash and investments and maintained its full-year 2026 non-GAAP R&D and SG&A expense outlook of $175 million to $195 million.
U.S. VYJUVEK revenue reaches $91.6 million
Krystal is expanding its outreach beyond specialized treatment centers and into community settings, where it expects to find additional patients. Chairman and CEO Krish Krishnan said the company continues to target roughly 1,200 identified U.S. patients and may eventually broaden its efforts toward an estimated 3,000 patients, many of whom may be undiagnosed.
Management said demand remains healthy, with approximately 35 to 50 reimbursement approvals per quarter. Krishnan said newer patients initiating treatment tend to be more moderate to mild cases, although both recessive DEB and dominant DEB patients continue to enter treatment.
Wilson also highlighted patient-support initiatives intended to help patients and caregivers incorporate VYJUVEK into ongoing wound-care routines, particularly as more patients use the therapy at home following the product’s label expansion. Those programs include virtual education events, peer-to-peer ambassador support through VYJUVEK Voices, and a new virtual discussion series called VYJUVEK Connections.
International launch growth offset by German pricing reserve
Laurent Goux, executive vice president and general manager for Europe, said physician engagement and patient demand were strong in Europe and Japan. More than 180 patients have been treated across Western Europe and Japan, according to management.
Reported revenue in Europe and Japan was broadly flat sequentially because of a reserve provision associated with Germany’s ongoing pricing process. Kate Romano, Krystal’s chief accounting officer, said the second quarter included a full quarter of accrued pricing in Germany, which reduced reported European net revenue even as related vial sales increased.
During the question-and-answer session, Krishnan said German demand and vial growth were in the double digits on a pre-accrual basis, though the company did not provide a precise figure. He said Krystal expects to complete German pricing negotiations in the third quarter, subject to a successful outcome, and hopes the accrual effect will largely be resolved by the fourth quarter.
Goux said the company expects pricing and reimbursement outcomes in Germany, Italy and Spain before the end of 2026, subject to country-specific processes. Formal pricing and reimbursement talks in France are expected to extend into 2027. In the United Kingdom, VYJUVEK received marketing authorization from the Medicines and Healthcare products Regulatory Agency in May, while a National Institute for Health and Care Excellence appraisal remains ongoing.
Krystal also plans regulatory submissions in Switzerland and Australia in coming months. Goux said France, Germany and Japan have shown strong demand, although each market presents operational differences, including fragmented care in Germany, hospital-based administration requirements in France and prescription-renewal demands in Japan.
Registrational readouts approach in eye programs
President of Research and Development Suma Krishnan said the company is approaching two registrational study readouts involving front-of-the-eye diseases.
The IOLITE study of KB803 for ocular lesions in DEB patients was fully enrolled in April, with a readout expected later this year. If successful, the company expects to move quickly toward a biologics license application, leveraging manufacturing work completed for VYJUVEK. The KB803 study is U.S.-based because it uses patient-reported outcomes as its primary endpoint.
Meanwhile, the EMERALD-1 study of KB801 in neurotrophic keratitis, or NK, is expected to complete enrollment before year-end. With an eight-week primary endpoint, management said data could be available in early 2027 after database cleaning. Krystal is adding European sites to support a global filing strategy but said it is not increasing the study’s planned enrollment.
Management described NK as a large and growing market based on claims trends and sales of an existing treatment, while noting that the disease remains underserved internationally. Krishnan cautioned investors against placing too much weight on previously disclosed results from one KB801 patient, saying the ongoing registrational study uses a different design.
CF, Hailey-Hailey and oncology programs advance
Krystal is also conducting repeat-dose studies of KB407 for cystic fibrosis and KB111 for Hailey-Hailey disease. The company expects to enroll approximately five cystic fibrosis patients and seven Hailey-Hailey patients, with interim results from both programs anticipated before year-end.
For KB407, the study will evaluate repeat weekly dosing in patients who are ineligible for or refractory to modulator therapy, including monthly assessments of lung function such as FEV1 over six months. Krystal expects to align with the FDA on a registrational cystic fibrosis study design later this year and begin that trial in 2027.
For KB111, Krystal has enrolled more than 60 to 70 patients in a natural-history study and is validating an assessment scale for Hailey-Hailey disease. The company expects to discuss repeat-dose safety data, the scale and a registrational design with the FDA before year-end, targeting a registrational study start in 2027.
In oncology, Krystal said inhaled KB707 remains on track for a registrational study in second-line non-small cell lung cancer in 2027. The company expects to complete enrollment later this year in its final dose-expansion cohort evaluating KB707 with chemotherapy. It also enrolled three patients with Gorlin syndrome in an expansion of its intratumoral KB707 study and expects to provide an update later this year.
Krishnan said the company aims to complete current registrational trials and begin at least two additional registrational studies in 2027, potentially supporting its transition into a multi-product genetic medicines company.
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.
