$97.8 million in 3Q VYJUVEK revenue and $623.2 million since U.S. launch

VYJUVEK launched in Germany in 3Q; launched in France and Japan in 4Q

Updated U.S. VYJUVEK label expands eligible patient population and provides greater patient flexibility

FDA grants platform technology designation

CF interim results expected in 4Q

Strong balance sheet, ending the quarter with $864.2 million in cash and investments

PITTSBURGH, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) today reported financial results for the third quarter ending September 30, 2025 and provided a business update.

"It is immensely gratifying to see a growing number of DEB patients worldwide benefit from access to VYJUVEK, and we look forward to rapidly and sustainably expanding that number in the months ahead," said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. "With multiple near-term readouts, starting with cystic fibrosis in Q4, and a strong balance sheet, Krystal is well positioned to advance our pipeline and deliver transformative therapies to patients with serious and rare diseases."

VYJUVEK$(R)$ (beremagene geperpavec-svdt, or B-VEC)

for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

   -- The Company recorded $97.8 million in VYJUVEK net product revenue for the 
      third quarter of 2025. Gross margin for the quarter was 96%. 
 
   -- The Company has secured over 615 reimbursement approvals for VYJUVEK in 
      the United States and continues to maintain strong access nationwide. 
 
   -- In September, the United States Food and Drug Administration (FDA) 
      approved a label update which expanded the VYJUVEK eligible patient 
      population to include DEB patients from birth and provided patients 
      greater flexibility with respect to VYJUVEK application, including the 
      option for patients or their caregivers to apply VYJUVEK at home on their 
      own. 
 
   -- In late August, the Company launched VYJUVEK in Germany, its first 
      commercial launch of VYJUVEK outside of the United States. The Company 
      estimates that approximately 20 patients have been prescribed VYJUVEK 
      therapy across Germany, with over 10 German centers prescribing VYJUVEK 
      to date. The Company has started discussions with payers in Germany and 
      expects pricing negotiations to continue until at least 2H 2026. 
 
   -- In September, the Haute Autorité de Santé $(HAS)$ in France 
      approved early reimbursed access to VYJUVEK under the post-marketing 
      authorization Accès Précoce AP2 program, including the option 
      to dispense VYJUVEK outside of the hospital setting, and, in October, the 
      Company launched VYJUVEK in France. Also in October, the HAS appraised 
      VYJUVEK as Amélioration du Service Médical Rendu (ASMR) III, a 
      designation which recognizes the added clinical benefit of VYJUVEK and is 
      an important milestone as the Company advances access discussions in 
      France. According to the Transparency Committee of the HAS, only 11% of 
      new medicines reviewed in 2024 were appraised as ASMR I-III. The Company 
      continues to engage with payers in France and expects negotiations to 
      continue for at least the next 15 months. 
 
   -- In October, the Company launched VYJUVEK in Japan following successful 
      completion of pricing negotiations with Japan's Ministry of Health, 
      Labour and Welfare. 
 
   -- Also in October, VYJUVEK was awarded the Prix Galien Italia in the 
      Advanced Therapy Medicinal Products category in Italy. The Prix Galien is 
      an international awards program recognizing excellence in scientific 
      innovation that improves the state of human health. 
 
   -- The Company is also preparing regulatory filings for the United Kingdom 
      and Switzerland, as well as initiating pricing discussions with relevant 
      authorities in other key Western European markets. The timing of European 
      launches outside of France and Germany will depend on the cadence and 
      outcomes of pricing negotiations. 
 
   -- In addition to the Company's direct VYJUVEK launches in the United States, 
      major European markets, and Japan, the Company is also building a 
      specialty distributor network to support commercialization of VYJUVEK in 
      the rest of world and has executed agreements with leading regional 
      specialty distributors covering key markets in the Middle East, Turkey, 
      and Central and Eastern Europe, with additional network expansion 
      expected in 2026. 

Respiratory

KB407 for the treatment of cystic fibrosis $(CF)$

   -- The Company continues to enroll in Cohort 3 of CORAL-1, the Company's 
      multi-center, dose escalation study evaluating KB407 in patients with CF, 
      regardless of their underlying genotype, and expects to provide an 
      interim data readout for Cohort 3 patients before year end. Details of 
      the study can be found at www.clinicaltrials.gov under NCT identifier 
      NCT05504837. 

KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease

   -- The Company continues to enroll in 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 1H 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 of 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

   -- The Company expects to complete enrollment in IOLITE, the Company's 
      intra-patient, double-blind, multicenter, placebo-controlled Phase 3 
      study with crossover design evaluating KB803 for the treatment and 
      prevention of corneal abrasions in DEB patients, before year end. The 
      primary study endpoint will be the change in the average number of days 
      per month with corneal abrasion symptoms while receiving KB803 versus 
      placebo. Details about the study can be found at www.clinicaltrials.gov 
      under NCT identifier: NCT07016750. 

KB801 for the treatment of neurotrophic keratitis (NK)

   -- The Company continues to enroll in EMERALD-1, the Company's 2:1 
      randomized, double-masked, multicenter, placebo-controlled study 
      evaluating KB801 for the treatment of NK. The primary objective of 
      EMERALD-1 is to evaluate the safety and tolerability of topical ocular 
      administration of KB801 in patients with NK. The secondary objective is 
      evaluation of efficacy based on the proportion of patients with complete 
      durable healing of corneal epithelium at eight weeks. Details about the 
      study can be found at www.clinicaltrials.gov under NCT identifier: 
      NCT06999733. 
 
   -- In October, the FDA granted platform technology designation to the 
      genetically modified, non-replicating herpes simplex virus type 1 viral 
      vector used in KB801. The FDA's platform technology designation program 
      is intended to provide efficiencies in drug development, manufacturing, 
      and review processes for drug product applications that incorporate 
      designated platform technologies, with potential benefits including more 
      frequent engagement with the FDA during clinical development, as well as 
      opportunities to leverage manufacturing and nonclinical safety data from 
      FDA-approved products that incorporate designated platform technologies, 
      such as VYJUVEK, in submissions to the FDA. 

Oncology

Inhaled KB707 for the treatment of solid tumors of the lung

   -- In August, the Company announced that the FDA had granted the Company an 
      End of Phase 2 meeting to discuss the inhaled KB707 program and early 
      evidence of efficacy for the treatment of non-small cell lung cancer 
      (NSCLC) from KYANITE-1, the Company's ongoing open label, multi-center, 
      dose escalation and expansion Phase 1/2 study. Based on the FDA's 
      feedback, the Company now expects that a single Phase 3 registrational 
      study, evaluating inhaled KB707 in combination with chemotherapy against 
      chemotherapy alone in patients with advanced NSCLC, would be sufficient 
      to support potential registration of inhaled KB707 in combination with 
      chemotherapy as a second-line treatment for NSCLC. 
 
   -- In support of this potential registrational pathway, the Company has 
      opened a new cohort in KYANITE-1 to evaluate a fixed inhaled dose of 
      KB707 in combination with chemotherapy in patients with advanced NSCLC. 
      Enrollment in KYANITE-1 is ongoing. The Company expects to report interim 
      efficacy data and potential registrational study plans in 2H 2026. 
      Details of the study can be found at www.clinicaltrials.gov under NCT 
      identifier NCT06228326. 

Intratumoral KB707 for the treatment of injectable solid tumors

   -- The Company has paused enrollment 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. Patients enrolled in OPAL-1 continue to be followed 
      and based on safety and efficacy results from the study, the Company may 
      adjust development plans for intratumoral KB707. Details of the study can 
      be found at www.clinicaltrials.gov under NCT identifier NCT05970497. 

Aesthetics

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November 03, 2025 07:00 ET (12:00 GMT)