Krystal Biotech reports strong Q2 results, driven by U.S. sales growth
Krystal Biotech saw a 24% annual increase in second-quarter revenue, totaling $119.2 million. U.S. sales for VYJUVEK, which treats dystrophic epidermolysis bullosa (DEB), brought in $91.6 million. Over 730 U.S. reimbursement approvals have been secured, exceeding the company’s initial goal of reaching 60% of diagnosed patients.
The company ended the quarter with over $1.1 billion in cash and investments. Krystal kept its 2026 non-GAAP R&D and SG&A expense forecast between $175 million and $195 million. Management, including Christine Wilson, noted progress in securing reimbursements and expanding treatment access beyond specialized centers into community settings, where new patients may be found.
European and Japanese revenue impacted by Germany pricing negotiations
Europe and Japan saw flat revenue during the second quarter, mainly due to a pricing reserve in Germany. Laurent Goux, Europe’s executive vice president, said over 180 patients in Western Europe and Japan received treatment. However, Germany’s ongoing pricing process led to a reserve that reduced reported revenue. Krystal expects German pricing negotiations to conclude in the third quarter, with the reserve effect likely resolved by the end of the year.
Krish Krishnan, the CEO, noted Germany is showing double-digit demand and vial growth before the reserve, though exact numbers weren’t shared. Talks in Italy and Spain are expected to wrap up by year-end. Formal discussions in France are set to continue into 2027, adding complexity to market entry.
VYJUVEK received UK approval in May via the Medicines and Healthcare products Regulatory Agency, while a National Institute for Health and Care Excellence review is still underway. Goux mentioned strong demand in France, Germany, and Japan but highlighted operational challenges like fragmented care in Germany and hospital-based requirements in France.
Key pipeline milestones approach for eye diseases
Krystal is nearing key phases in its trials for eye-related conditions. The EMERALD-1 study for KB801 could provide data in early 2027. Repeat-dose studies for cystic fibrosis and Hailey-Hailey disease are set to release interim findings in 2026, supporting registration trials in 2027.
Suma Krishnan, head of R&D, emphasized the importance of these trials for Krystal’s long-term vision. These studies open up new uses for VYJUVEK and other treatments, allowing the company to explore additional applications. Krystal is also working to expand outreach to community settings to reach more patients, including those who may not yet have a confirmed DEB diagnosis.
To help patients manage treatment, Krystal launched programs like VYJUVEK Voices and VYJUVEK Connections, offering education and peer support. These initiatives help patients and caregivers integrate VYJUVEK into wound care routines, especially as more people use the therapy at home after a label expansion. Krystal’s efforts to improve access and support patients show its commitment to better outcomes for DEB patients.
Krystal is also running several patient-focused programs, including virtual education events and the VYJUVEK Voices peer support network. The company recently introduced a new virtual discussion series called VYJUVEK Connections to help patients and caregivers learn how to use VYJUVEK effectively, especially as home use becomes more common following the product’s label expansion.
Krish Krishnan, CEO, reiterated the company’s goal of expanding treatment access for DEB patients both in the U.S. and globally. Krystal is working to identify more patients, including those who may not have a confirmed diagnosis, which could significantly expand the patient population. Around 35 to 50 reimbursement approvals are received each quarter, ensuring patients can continue to access the therapy.
Looking ahead, Krystal is targeting around 3,000 U.S. patients, many who may not have a confirmed DEB diagnosis. The company is also preparing regulatory submissions for Switzerland and Australia in the near future. These efforts are part of Krystal’s broader strategy to grow its market reach and ensure patients worldwide can access VYJUVEK.
Krystal’s leadership, including Christine Wilson, is focusing on reaching patients in community settings, which could lead to discovering more individuals with undiagnosed DEB. By expanding into these areas, the company aims to increase its patient base and improve treatment outcomes.
Financially, Krystal maintained a stable forecast for 2026, with non-GAAP R&D and SG&A expenses expected to remain between $175 million and $195 million. This financial stability allows Krystal to invest in research while continuing to expand its commercial operations.
Krystal remains committed to improving treatment access and supporting patients, which highlights its dedication to better outcomes for those with DEB. The company plans to continue growing in the U.S. while managing international challenges, particularly in Germany where pricing discussions are ongoing. Resolving these could boost revenue in the fourth quarter.