Preliminary 4Q 2025 VYJUVEK net revenue of
Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth
“2025 was a standout year for Krystal, with the successful launch of VYJUVEK in
Preliminary and Unaudited Fourth Quarter and Full Year 2025 Financial Updates
Based on preliminary unaudited financial information, the Company expects net product revenue for VYJUVEK to be between
Cash, cash equivalents, and investments were approximately
These preliminary unaudited results are based on management’s initial analysis of operations for the year ended
Rare Disease Strategic Vision and 2026 Corporate Objectives
Over 300 million people around the world are living with rare diseases, many of whom lack adequate therapies. With global rare disease drug development and launch infrastructure and a redosable HSV-1 platform with Platform Technology Designation that is well-suited for gene delivery to high turnover tissues in the skin, lung, and eye, the Company is uniquely positioned to help fill this treatment gap.
To that end, the Company is accelerating and expanding clinical development efforts for its rare disease pipeline of programs:
- KB803 for ocular complications of dystrophic epidermolysis bullosa (DEB)
- KB801 for neurotrophic keratitis (NK)
- KB407 for cystic fibrosis (CF)
- KB111 for Hailey-Hailey disease (HHD)
In support of potential expedited development of KB801 for the treatment of NK, the Company has increased the enrollment target of its ongoing registrational double-masked, randomized, placebo-controlled study from 27 to 60 patients. The Company will provide a detailed update on the registrational study design when it reports its 2025 financial results in
The Company’s strategic vision is to have at least four marketed rare disease medicines, inclusive of VYJUVEK, by the end of 2030, treating over 10,000 patients worldwide.
The Company expects to achieve these goals while remaining profitable throughout the period and continuing to invest strategically across its broader preclinical and clinical pipeline, including programs targeting larger indications such as KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer.
To achieve the Company’s broader ambitions in rare disease, the Company’s corporate objectives for 2026 include:
- Launch VYJUVEK in at least one more major European market and expand specialty distributor network to cover over 40 countries
- Report top-line results from its registrational Phase 3 study evaluating KB803 for the treatment of ocular complications of DEB
- Report top-line results from its registrational double-masked, randomized, placebo-controlled study evaluating KB801 for the treatment of NK
- Initiate and complete enrollment in a registrational repeat dose study evaluating KB407 for the treatment of CF
- Dose first patient in registrational double-blind, intra-patient randomized, placebo-controlled study evaluating KB111 in HHD patients
The Company also expects to report updates for both KB408 and KB707 before the end of the year.
Based on its current operating plans, the Company expects its combined non-GAAP R&D and SG&A expense in 2026 to be between
44th Annual J.P. Morgan Healthcare Conference Presentation and Webcast
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Forward-Looking Statements
Statements in this press release about future expectations, plans, and prospects, as well as statements that are not historical facts, including statements about, among other topics, our selected preliminary and unaudited financial results for 2025; our strategic vision and our 2026 corporate goals; our combined R&D and SG&A expense guidance; and our expectations for our product pipeline, including clinical trial plans, enrollment in clinical trials, and the timing of initiating clinical trials, dosing patients, data read-outs, and regulatory submissions may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Undue reliance should not be placed on the forward-looking statements in this press release. These statements are not guaranties of future performance and actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the availability or commercial potential of VYJUVEK or our product candidates; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The Company is providing the information in this press release as of the date hereof and undertakes no duty to update this information unless required by law.
Non-GAAP Financial Measure
This press release includes forward-looking combined R&D and SG&A expense guidance that is not required by, or presented in accordance with,
CONTACT
Investors and Media:
spaquette@krystalbio.com
Source: Krystal Biotech, Inc.