On February 17, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update.
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"In 2025, Krystal made meaningful progress on our mission to serve patients with dystrophic epidermolysis bullosa around the world, while continuing to build the global infrastructure required to scale our impact," said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. "As we work toward our goal of launching multiple products and treating more than 10,000 patients living with rare diseases by the end of 2030, our recent cystic fibrosis readout further reinforces the versatility of our platform in high-turnover epithelial tissues. We believe we are still in the early stages of unlocking the transformational potential of our redosable HSV-1-based gene delivery platform, and we look forward to multiple registrational study readouts ahead across our rare disease pipeline."
VYJUVEK (beremagene geperpavec-svdt, or B-VEC)
for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
The Company recorded $107.1 million and $389.1 million in VYJUVEK net product revenue for the fourth quarter and full year of 2025, respectively. Gross margin for the fourth quarter and full year of 2025 was 94%.
The Company has secured over 660 reimbursement approvals for VYJUVEK in the United States and continues to maintain strong access nationwide.
High patient demand is driving steady VYJUVEK uptake since launch in Germany, France and Japan. The Company estimates that over 90 patients have been prescribed VYJUVEK therapy across Germany, France, and Japan.
Pricing discussions with German and French reimbursement authorities are ongoing. The Company expects negotiations to continue until at least 2H 2026 in Germany and until at least 2027 in France.
The Company is also advancing pricing discussions with the reimbursement authorities in Italy and is currently on track for a potential launch in 2H 2026. The timing of additional European launches will depend on the cadence and outcomes of regulatory interactions and pricing negotiations.
In December 2025, VYJUVEK was awarded the Prix Galien France in the Innovative Therapy Medicines category. The Prix Galien is an international awards program created recognizing excellence in scientific innovation that improves the state of human health. Earlier in 2025, VYJUVEK was also awarded the Prix Galien Italia in the Advanced Therapy Medicinal Products category in Italy.
In February 2026, the Company executed an agreement with a leading regional specialty distributor to support commercialization of VYJUVEK in Israel. The Company remains on track to achieve its objective of expanding its specialty distributor network to cover over 40 countries by the end of 2026.
Respiratory
KB407 for the treatment of cystic fibrosis (CF)
In January 2026, the Company announced a positive clinical update from the highest dose cohort of CORAL-1, the Company’s multi-center, dose escalation Phase 1 study evaluating KB407 in patients with CF, confirming lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407. Airway cell transduction by KB407 was observed in all patients with successful bronchoscopies, irrespective of modulator-status and genetic background, with broad airway distribution and transduction as assessed by CFTR or viral marker immunofluorescence ranging from 29.4% to 42.1% of conducting airway cells. Inhaled KB407 continued to be well tolerated by patients treated at the highest dose, consistent with the safety profile previously reported from lower dose cohorts. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT05504837.
The Company is currently engaged in discussions with the United States Food and Drug Administration (FDA) regarding the design of the Company’s proposed repeat dosing study CORAL-3, which is intended to evaluate the safety and efficacy of repeat KB407 administration, including through regular assessments of lung function by spirometry, and to support potential registration. The Company expects to align on the CORAL-3 study design with the FDA and start enrollment in CORAL-3 in 1H 2026. Additional details on the study design will be provided by the time of study initiation.
KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease
The Company continues to enroll patients in the repeat dose Cohort 2B of SERPENTINE-1, the Company’s open label dose escalation study evaluating KB408 in adult patients with AATD with a Pi*ZZ or a Pi*ZNull genotype, and expects to report interim data for this cohort in 2026. Cohort 2B is designed to evaluate the safety and tolerability of repeat KB408 dosing at the same dose level that was previously shown to safely deliver SERPINA1 to the lungs of AATD patients after a single dose. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06049082.
Ophthalmology
KB803 for the treatment and prevention of corneal abrasions in DEB patients
Based on the promising clinical safety profile observed to date with both KB803 and KB801, the Company has modified the KB803 dosing regimen in the registrational IOLITE study to maximize convenience for patients and their caregivers while reducing potential impact of human error in eye drop administration in the home setting. The Phase 3 registrational IOLITE study is an intra-patient, double-blind, decentralized, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients. Patients are receiving either KB803 or placebo three times weekly in the home setting with the option of administration by a healthcare professional (HCP), a trained caregiver, or by the patient themselves. Enrollment in IOLITE is ongoing. The Company expects to complete enrollment in 1H 2026 and report top-line results before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07016750.
KB801 for the treatment of neurotrophic keratitis (NK)
To support expedited development of KB801 and facilitate patient or caregiver administration at home, the Company has also updated the protocol of its registrational, randomized, double-masked, multicenter, placebo-controlled study, EMERALD-1, evaluating KB801 for the treatment of NK. Patients are receiving KB801 or placebo control daily with the option of administration by either a HCP, a trained caregiver, or by the patient themselves. The Company expects to enroll approximately 60 patients in the study, randomized 1:1 to KB801 and placebo. Enrollment in EMERALD-1 is ongoing, and the Company expects to announce data before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06999733.
Dermatology
KB111 for the treatment of Hailey-Hailey disease (HHD)
In January 2026, the FDA granted KB111 Fast Track Designation for the treatment of HHD.
The Company has initiated development of an HHD-specific evaluation scale necessary for the clinical evaluation of KB111. The Company expects to complete development and validation of the scale in 1H 2026 and initiate a registrational study evaluating KB111 for the treatment of HHD in 2H 2026.
Oncology
Inhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)
In February 2026, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707 for the treatment of advanced or metastatic NSCLC. The FDA’s RMAT designation is intended to support and expedite the development of regenerative medicine therapies, including gene therapies such as KB707.
The Company is enrolling patients with advanced NSCLC in a dose expansion cohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy. KYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707, either as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung. The Company expects to report interim efficacy data and potential registrational study plans later this year. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.
Intratumoral KB707 for the treatment of injectable solid tumors
The Company continues to follow patients enrolled in OPAL-1, the Company’s Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. The Company will update its development plans for intratumoral KB707 as additional safety and efficacy data are collected from the study. Details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.
Aesthetics
KB304 for the treatment of wrinkles of the décolleté
Jeune Aesthetics, Inc. ("Jeune"), a wholly-owned subsidiary of the Company, has aligned with the FDA on Jeune’s validated décolleté-specific photonumeric scale and expects to now initiate a Phase 2 study of its lead program, KB304, in 2027.
Financial Results for the Quarter Ended December 31, 2025:
Cash, cash equivalents, and investments totaled $955.9 million as of December 31, 2025.
Product revenue, net totaled $107.1 million and $91.1 million for the quarters ended December 31, 2025 and December 31, 2024, respectively.
Cost of goods sold totaled $6.6 million and $4.9 million for the quarters ended December 31, 2025 and December 31, 2024, respectively.
Research and development expenses for the quarter ended December 31, 2025 were $14.8 million, inclusive of $2.7 million of stock-based compensation, compared to $13.5 million, inclusive of stock-based compensation of $2.3 million for the quarter ended December 31, 2024.
Selling, general, and administrative expenses for the quarter ended December 31, 2025 were $41.4 million, inclusive of stock-based compensation of $11.1 million, compared to $31.3 million, inclusive of stock-based compensation of $11.0 million, for the quarter ended December 31, 2024.
Net income for the quarter ended December 31, 2025 was $51.4 million, or $1.77 per common share (basic) and $1.70 per common share (diluted). Net income for the quarter ended December 31, 2024 was $45.5 million, or $1.58 per common share (basic) and $1.52 per common share (diluted).
Financial Results for the Twelve Months Ended December 31, 2025:
Product revenue, net totaled $389.1 million and $290.5 million for the twelve months ended December 31, 2025 and December 31, 2024, respectively.
Cost of goods sold totaled $23.0 million and $20.1 million for the twelve months ended December 31, 2025 and December 31, 2024, respectively.
Research and development expenses for the twelve months ended December 31, 2025 were $58.0 million, inclusive of $10.4 million of stock-based compensation, compared to $53.6 million, inclusive of stock-based compensation of $9.2 million for the twelve months ended December 31, 2024.
Selling, general, and administrative expenses for the twelve months ended December 31, 2025 were $146.7 million, inclusive of stock-based compensation of $44.1 million, compared to $113.6 million, inclusive of stock-based compensation of $39.9 million, for the twelve months ended December 31, 2024.
Net income for the twelve months ended December 31, 2025 was $204.8 million, or $7.08 per common share (basic) and $6.84 per common share (diluted). Net income for the twelve months ended December 31, 2024 was $89.2 million, or $3.12 per common share (basic) and $3.00 per common share (diluted).
For additional information on the Company’s financial results for the twelve months ended December 31, 2025, please refer to the Form 10-K filed with the SEC.
Financial Guidance
($ in millions) FY 2026 Guidance
Non-GAAP Research and Development ("R&D") and Selling, General and Administrative ("SG&A") expense(1) $175.0 – $195.0
(1) Refer to Non-GAAP Financial Measures section below for additional information. Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation as we are currently unable to confidently estimate Full Year 2026 stock-based compensation expense. As such, we have not provided a reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and SG&A Expense in the above. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain.
Conference Call
The Company will host an investor webcast on February 17, 2026, at 8:30 am ET.
Investors and the general public can access the live webcast at:
View Source
For those unable to listen to the live conference call, a replay will be available for 30 days on the Investors section of the Company’s website at www.krystalbio.com.
(Press release, Krystal Biotech, FEB 17, 2026, View Source [SID1234662727])