お知らせ • May 20
Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. ライブニュース • May 17
Krystal Biotech Gains UK Approval for Vyjuvek in Rare Skin Disorder Treatment Krystal Biotech received approval from the UK Medicines and Healthcare products Regulatory Agency on May 15, 2026, for Vyjuvek, its wound treatment for dystrophic epidermolysis bullosa (DEB).
Vyjuvek targets patients with DEB, a rare genetic disorder with limited treatment options, addressing an area of high medical need.
This approval adds a new product to Krystal Biotech's portfolio and positions the company more clearly in rare disease therapies.
The MHRA decision gives Krystal Biotech regulatory validation for its approach to treating DEB and opens access to patients in the UK health system.
Investors may want to watch how quickly the company can translate this approval into uptake, reimbursement agreements and the generation of real-world data in a rare-disease setting. Reported Earnings • May 05
First quarter 2026 earnings: EPS and revenues exceed analyst expectations First quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 46% per year, which means it is significantly lagging earnings growth. お知らせ • Apr 24
Krystal Biotech, Inc. to Report Q1, 2026 Results on May 04, 2026 Krystal Biotech, Inc. announced that they will report Q1, 2026 results Pre-Market on May 04, 2026 お知らせ • Apr 07
Krystal Biotech, Inc., Annual General Meeting, May 15, 2026 Krystal Biotech, Inc., Annual General Meeting, May 15, 2026. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Catherine Mazzacco was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Price Target Changed • Feb 25
Price target increased by 8.3% to US$313 Up from US$289, the current price target is an average from 9 analysts. New target price is 17% above last closing price of US$267. Stock is up 47% over the past year. The company is forecast to post earnings per share of US$7.84 for next year compared to US$7.08 last year. Recent Insider Transactions Derivative • Feb 20
Independent Director notifies of intention to sell stock Dino Rossi intends to sell 19k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of February. If the sale is conducted around the recent share price of US$261, it would amount to US$5.0m. Since March 2025, Dino has owned 78.69k shares directly. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Feb 18
Full year 2025 earnings: Revenues and EPS in line with analyst expectations Full year 2025 results: EPS: US$7.08 (up from US$3.12 in FY 2024). Revenue: US$389.1m (up 34% from FY 2024). Net income: US$204.8m (up 130% from FY 2024). Profit margin: 53% (up from 31% in FY 2024). The increase in margin was primarily driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) were also in line with analyst expectations. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions Derivative • Feb 10
Executive VP & Chief Accounting Officer notifies of intention to sell stock Kathryn Romano intends to sell 13k shares in the next 90 days after lodging an Intent To Sell Form on the 9th of February. If the sale is conducted around the recent share price of US$277, it would amount to US$3.5m. Since March 2025, Kathryn has owned 19.32k shares directly. Company insiders have collectively sold US$7.5m more than they bought, via options and on-market transactions in the last 12 months. Valuation Update With 7 Day Price Move • Jan 13
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to US$292, the stock trades at a forward P/E ratio of 37x. Average trailing P/E is 21x in the Biotechs industry in the US. Total returns to shareholders of 262% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$560 per share. お知らせ • Jan 09
Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 Coral-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis Krystal Biotech, Inc. announced a positive interim 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 cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407. Price Target Changed • Jan 09
Price target increased by 9.3% to US$250 Up from US$229, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$249. Stock is up 59% over the past year. The company is forecast to post earnings per share of US$6.74 for next year compared to US$3.12 last year. お知らせ • Jan 08
Krystal Biotech to Announce Interim Clinical Update from Highest Dose Cohort of Phase 1 CORAL-1 Study Evaluating KB407 in Patients with Cystic Fibrosis Krystal Biotech, Inc. announced that it will host an investor conference call and webcast on January 8, 2026, to disclose an interim clinical update from CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis. The interim clinical update will focus on results from patients in the highest dose cohort of CORAL-1 and include molecular assessments of KB407 transduction and wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein expression following inhaled administration of KB407. Price Target Changed • Dec 18
Price target increased by 7.8% to US$229 Up from US$213, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$236. Stock is up 51% over the past year. The company is forecast to post earnings per share of US$6.58 for next year compared to US$3.12 last year. Major Estimate Revision • Nov 10
Consensus EPS estimates increase by 19% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has improved. 2025 revenue forecast increased from US$383.7m to US$388.8m. EPS estimate increased from US$5.08 to US$6.03 per share. Net income forecast to grow 23% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target up from US$213 to US$220. Share price was steady at US$198 over the past week. Reported Earnings • Nov 04
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: EPS: US$2.74 (up from US$0.95 in 3Q 2024). Revenue: US$97.8m (up 17% from 3Q 2024). Net income: US$79.4m (up 192% from 3Q 2024). Profit margin: 81% (up from 32% in 3Q 2024). The increase in margin was primarily driven by lower expenses. Revenue exceeded analyst estimates by 4.7%. Earnings per share (EPS) also surpassed analyst estimates by 145%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 114% per year but the company’s share price has only increased by 37% per year, which means it is significantly lagging earnings growth. お知らせ • Oct 21
Krystal Biotech, Inc. to Report Q3, 2025 Results on Nov 03, 2025 Krystal Biotech, Inc. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 03, 2025 お知らせ • Oct 15
Krystal Biotech, Inc. Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic Keratitis Krystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK). 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. Potential benefits of the designation may include early and more frequent engagement with the FDA during clinical development as well as the opportunity to leverage manufacturing and nonclinical safety data from a prior product using the designated platform technology, such as VYJUVEK, in submissions to the FDA. The FDA may also consider previous inspectional findings related to the manufacture of a drug that incorporates the designated platform technology. To be eligible for a platform technology designation, a technology must be well-understanding and reproducible, used in an FDA-approved drug or biologic product, such as VYJ UVEK, have the potential to support the development of multiple drugs or biologic products without compromising quality, manufacturing, or safety, and have a reasonable likelihood to bring significant efficiencies to the development or manufacturing process as well as to the FDA review process. Drug product applications that are then recognized by the FDA to incorporate this technology may leverage the potential benefits of the designation. KB801 is a redosable eye drop gene treatment designed to enable sustained, localized expression and secretion of vein growth factor (NGF) by epithelial cells in the front of the eye for the treatment of NK, a rare,degenerative corneal disease that leads to corneal epithelial defects, ulcers, and perforation. Recombinant NGF eye drops have been shown to significantly improve corneal healing and are approved for the treatment of NK in multiple jurisdictions worldwide, but rapid clearance from the eye requires intensive administration six times a day, limiting therapeutic utility. By enabling the cells of the front of the eye to produce NGF locally, KB801 has the potential to significantly reduce the treatment burden for patients while also maintaining more consistent NGF levels in the front of the eye. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. お知らせ • Sep 16
Krystal Biotech Announces FDA Approval of Updated VYJUVEK Label Krystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK®? (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in the United States, as well as results from the open label extension study conducted in the United States and published earlier this year, which collectively reinforce the long-term safety and efficacy of VYJUVEK across patients of all ages, including in cases of patient or caregiver application. VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEk was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVE K is approved in the United States, Europe, and Japan. VYJUVE k gel may be applied by a healthcare provider, a caregiver, or the patient. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.ash hands and wear protective gloves when changing wound dressings. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Reported Earnings • Aug 04
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: EPS: US$1.33 (up from US$0.54 in 2Q 2024). Revenue: US$96.0m (up 37% from 2Q 2024). Net income: US$38.3m (up 146% from 2Q 2024). Profit margin: 40% (up from 22% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 4.4%. Earnings per share (EPS) also surpassed analyst estimates by 14%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 110% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth. お知らせ • Jul 29
Krystal Biotech, Inc. to Report Q2, 2025 Results on Aug 04, 2025 Krystal Biotech, Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 04, 2025 お知らせ • Jul 25
Krystal Biotech Announces Approval of VYJUVEK by Japan's Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that on July 24, 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB), starting from birth. VYJUVEK is the first genetic medicine approved in Japan for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The Japanese approval allows for dosing at home or in a healthcare setting, with the option for administration by patients or their family members. As per the approval issued by the MHLW, VYJUveK is intended for use only in patients with a definite diagnosis of dystrophic epidermorysis bullosa. Genetic testing is not a requirement for treatment. VYJUVE K is the first genetic medicine approved In Japan for home administration after undergoing regulatory evaluation and environmental safety confirmation for type 1 use in accordance with the Cartagena Act. The timing for availability of VYJUVEK in Japan will depend on completion of reimbursement procedures currently underway. The Company currently expects to launch in Japan by the end of this year. The approval by Japan's MHLW was based on a comprehensive clinical dataset, which included results from an open label extension study conducted in Japanese patients. Results from the Japanese open label extension study closely mirrored prior clinical experience, including the Company's Phase 3 study in the United States, with all four patients that completed the study achieving the primary study endpoint of full wound closure at six months. VYJUVEk was also well tolerated and exhibited a safety profile in Japanese patients that was consistent with previous studies. The re- examination period for VYJUVEK In Japan is ten years. VYJUVEV was previously approved by the Food and Drug Administration in the United States in May 2023 and by the European Commission in April 2025. JAPAN INDICATION: Dystrophic epidermolytic bullosa. お知らせ • Jul 09
Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of Kb801 for the Treatment of Neurotrophic Keratitis Krystal Biotech, Inc. announced that the first patient has been dosed in its Phase 1/2 clinical trial ("EMERALD-1"), a 2:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of neurotrophic keratitis (NK). KB801 is a redosable eye drop gene therapy in development for the treatment of NK, a degenerative corneal disease characterized by damage or loss of function in the neurons innervating the eye leading to corneal
epithelial defects, ulcers, and perforation. Left untreated, NK can result in severe vision loss. Although NK is a rare disease with an estimated prevalence in the range of 10 to 50 cases per 100,000, claims data analyses suggest awareness and diagnosis rates are on the rise in the United States. Based on available claims data, an estimated 68,000 patients in the United States had a NK claim in 2024, up over 115% from 31,000 patients with a NK claim in 2020. EMERALD-1 is a randomized, double-masked, multicenter, placebo-controlled study evaluating KB801, administered as an eye drop, for the treatment of NK. Up to 27 adults with Stage 2 or Stage 3 NK, as defined by the Mackie criteria, will be enrolled and randomized 2:1 to receive either KB801, at a concentration of 1010 PFU/mL, or placebo topically to the study eye twice weekly for 8 weeks. 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 8 weeks, defined as 0 mm corneal fluorescein staining in the area of the corneal lesion at both week 8 and 0 mm corneal fluorescein staining in the same area at week 10, as assessed by a masked reader. Additional exploratory efficacy measures will include change in corneal lesion size from baseline, each assessed at weeks 4, 6, 8, 10, and 20, as well as evaluations of corneal sensation and patient-reported symptom burden. More details of the EMERALD-1 study can be found at www.clinicaltrials.gov under NCT identifier NCT06999733. お知らせ • Jun 25
Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of Kb803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that the first patient has been dosed in its Phase 3 clinical trial ("IOLITE"), an intra-patient, double-blind, multicenter, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. KB803 is designed to deliver two copies of the COL7A1 transgene to the corneal epithelium and enable local type VII collagen production in the front of the eye. IOLITE is an intra- patient, double-blind, placebo-controlled, multicenter Phase 3 study with a crossover design to evaluate KB803, administered as an eye drop, for the treatment and prevention of Corneal abrasions in DEB patients, 6 months of age or older. Patients seeking to participate in IOLITE must first enroll in the ongoing natural history study and complete a 12-week run-in period, during which they report the number of days that they experience symptoms of corneal abrasions. Subjects meeting the inclusion criteria following the 12-week run-in are eligible to participate in the IOLITE trial. The goal of therapy with KB803 is to address the fundamental disease-causing mechanism at the molecular level, by providing the patient's epithelial cells of the eye with the template to make normal type VII collagen locally. In a DEB patient treated under compassionate use with clinical observations reported the New England Journal of Medicine, regular eye drop administration was well tolerated with full corneal healing observed at three months, as well as significant visual acuity improvement from hand motion to 20/25 by eight months. お知らせ • Jun 03
Krystal Biotech Presents Phase 1/2 Clinical Trial Results for Inhaled KB707 in Lung Cancer at ASCO 2025 On June 2, 2025, Krystal Biotech, Inc. provided a clinical update on the monotherapy cohort from its Phase 1/2 clinical trial of inhaled KB707 for the treatment of solid tumors of the lung, which was presented by Wen Wee Ma, MD, Enterprise Vice Chair, Research, Cancer Institute, Cleveland Clinic, in a poster entitled “Inhaled KB707, a Novel HSV-based Immunotherapy, as a Monotherapy in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs: Efficacy and Safety Results from a Phase 1/2 Study” at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Reported Earnings • May 07
First quarter 2025 earnings: EPS and revenues miss analyst expectations First quarter 2025 results: EPS: US$1.24 (up from US$0.033 in 1Q 2024). Revenue: US$88.2m (up 95% from 1Q 2024). Net income: US$35.7m (up US$34.8m from 1Q 2024). Profit margin: 41% (up from 2.1% in 1Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 8.3%. Earnings per share (EPS) also missed analyst estimates by 12%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 102% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth. お知らせ • Apr 28
Krystal Biotech Announces European Commission Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. VYJUveK is the first corrective medicine approved in Europe for the treatment of DEB. The approval granted by the EC allows for flexible VYJUVEK dosing either at home or in healthcare setting, with the option for patient or caregiver administration if deemed appropriate by a healthcare professional. The EC approval follows the positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in February and was based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company's open label extension study and real-world experience in the United States. VYJUVEk was approved by the FDA in the United States in May 2023 and is also under review for approval by Japan's Pharmaceuticals and Medical Devices Agency with a decision expected in 2H 2025. VYJUVE K is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patient from birth with dystrophic epider molysis bullosa with mutation(s) in the collagen type VII alpha1 chain (COL7A1). お知らせ • Apr 17
Krystal Biotech, Inc. to Report Q1, 2025 Results on May 06, 2025 Krystal Biotech, Inc. announced that they will report Q1, 2025 results Pre-Market on May 06, 2025 お知らせ • Apr 04
Krystal Biotech, Inc., Annual General Meeting, May 16, 2025 Krystal Biotech, Inc., Annual General Meeting, May 16, 2025. Recent Insider Transactions Derivative • Mar 14
Founder notifies of intention to sell stock Krish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of March. If the sale is conducted around the recent share price of US$178, it would amount to US$4.5m. For the year to December 2018, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Mar 02
Executive VP & Chief Accounting Officer exercised options and sold US$1.0m worth of stock On the 28th of February, Kathryn Romano exercised options to acquire 6k shares at no cost and sold these for an average price of US$179 per share. This trade did not impact their existing holding. Since March 2024, Kathryn has owned 12.94k shares directly. Company insiders have collectively sold US$3.9m more than they bought, via options and on-market transactions in the last 12 months. お知らせ • Feb 28
Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Krystal Biotech, Inc. welcomed the European Medicines Agency's (EMA's) announcement that its Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK® (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. The CHMP's positive opinion includes support for administration of VYJUVEK in either a health care setting (e.g., a clinic) or at home. If deemed appropriate by a healthcare professional, trained patients or caregivers may also apply VYJUVEK. The positive opinion issued by the CHMP is based on a comprehensive clinical dataset including results from the Company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, published in Nature Medicine and the New England Journal of Medicine, respectively, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration. The long-term safety and efficacy of B-VEC is further supported by results from the Company's open label extension study completed in the United States as well as real-world experience with VYJUVEK since launching the United States in 2023. Valuation Update With 7 Day Price Move • Feb 26
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to US$181, the stock trades at a forward P/E ratio of 25x. Average trailing P/E is 17x in the Biotechs industry in the US. Total returns to shareholders of 182% over the past three years. Reported Earnings • Feb 19
Full year 2024 earnings: EPS exceeds analyst expectations Full year 2024 results: EPS: US$3.12 (up from US$0.40 in FY 2023). Revenue: US$290.5m (up 473% from FY 2023). Net income: US$89.2m (up US$78.2m from FY 2023). Profit margin: 31% (up from 22% in FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 7.9%. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 87% per year but the company’s share price has only increased by 45% per year, which means it is significantly lagging earnings growth. お知らせ • Feb 06
Krystal Biotech, Inc. to Report Q4, 2024 Results on Feb 19, 2025 Krystal Biotech, Inc. announced that they will report Q4, 2024 results Pre-Market on Feb 19, 2025 お知らせ • Dec 19
Krystal Biotech Announces Early Evidence of Monotherapy Activity in Heavily Pre-Treated Patients with Advanced Non-Small Cell Lung Cancer Krystal Biotech, Inc. announced initial clinical results from its ongoing KYANITE-1 study evaluating inhaled KB707 in patients with solid tumors of the lung. KB707 administered via inhalation demonstrated early evidence of monotherapy activity that was most pronounced in patients with advanced non-small cell lung cancer (NSCLC), where an objective response rate (ORR) of 27% and disease control rate (DCR) of 73% were observed as of data cut-off on December 6, 2024. KYANITE-1 is an ongoing, open-label, multicenter, dose escalation and expansion study evaluating inhaled KB707 for the treatment of solid tumors of the lung. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient's tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation. Recent Insider Transactions Derivative • Dec 15
Founder notifies of intention to sell stock Krish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of December. If the sale is conducted around the recent share price of US$173, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Krish's direct individual holding has decreased from 1.61m shares to 1.56m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months. お知らせ • Dec 13
Krystal Biotech, Inc. Announces Initial Clinical Update for Rare Respiratory Disease Programs KB408 and KB407 Krystal Biotech, Inc. announced clinical data updates for both KB408 and KB407, the Company's clinical-stage, inhaled genetic medicine programs in Phase 1 for the treatment of rare respiratory diseases. Today's updates include molecular data from multiple patients demonstrating SERPINA1 delivery and alpha-1 antitrypsin (AAT) expression within the respiratory tract following KB408 administration as well as safety and tolerability data for both KB407 and KB408 that, taken together, highlight the potential of the Company's platform to safely deliver genetic cargo to the lung. KB408 for the treatment of alpha-1 antitryps in lung disease. KB408 is being evaluated in the Company's Phase 1 SERPENTINE-1 study. The Company expects to report data from Cohort 3 in 1H 2025, including data on CFTR gene delivery and expression in patients with cystic fibrosis. VYJUVEK®? is the Company's first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa. お知らせ • Dec 10
Krystal Biotech Provides Update on EMA’s Ongoing Regulatory Review of B-VEC for Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company’s Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) that was scheduled for December 6, 2024, and asked the Company to submit written responses to the remaining outstanding issues.
There are no Major Objections outstanding from the EMA with respect to the full approval of B-VEC. The Company now anticipates a CHMP opinion in First Quarter 2025 while the launch timelines remain unchanged with a commercial launch in Germany still planned for Second Quarter 2025.
About Dystrophic Epidermolysis Bullosa (DEB)
DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal. About B-VEC and VYJUVEK
B-VEC is a non-invasive, redosable gene therapy built to deliver two copies of the COL7A1 gene to treat DEB at the molecular level by providing the patient’s cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. B-VEC was approved by U.S. Food and Drug Agency (FDA) in May 2023 for the treatment of DEB and is marketed and sold in the U.S. under the name VYJUVEK®. お知らせ • Oct 28
Krystal Biotech, Inc. to Report Q3, 2024 Results on Nov 04, 2024 Krystal Biotech, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 04, 2024 Recent Insider Transactions Derivative • Sep 15
Founder notifies of intention to sell stock Suma Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of September. If the sale is conducted around the recent share price of US$199, it would amount to US$5.0m. Since December 2023, Suma's direct individual holding has decreased from 1.66m shares to 1.62m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Aug 28
Price target increased by 7.5% to US$204 Up from US$190, the current price target is an average from 9 analysts. New target price is approximately in line with last closing price of US$204. Stock is up 60% over the past year. The company is forecast to post earnings per share of US$2.59 for next year compared to US$0.40 last year. Major Estimate Revision • Aug 05
Consensus revenue estimates increase by 11% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$269.1m to US$299.6m. EPS estimate increased from US$2.33 to US$2.67 per share. Net income forecast to grow 72% next year vs 9.7% decline forecast for Biotechs industry in the US. Consensus price target of US$193 unchanged from last update. Share price fell 12% to US$181 over the past week. お知らせ • Jul 26
Krystal Biotech, Inc. to Report Q2, 2024 Results on Aug 05, 2024 Krystal Biotech, Inc. announced that they will report Q2, 2024 results Pre-Market on Aug 05, 2024 Recent Insider Transactions Derivative • Jun 13
Founder notifies of intention to sell stock Krish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of June. If the sale is conducted around the recent share price of US$177, it would amount to US$4.4m. For the year to December 2017, Krish's total compensation was 12% salary and 88% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2023, Krish's direct individual holding has decreased from 1.66m shares to 1.61m. Company insiders have collectively sold US$6.4m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • May 22
Independent Director notifies of intention to sell stock Julian Gangolli intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of May. If the sale is conducted around the recent share price of US$164, it would amount to US$3.3m. Since March 2024, Julian has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$17m more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • May 13
Consensus EPS estimates increase by 16% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$260.0m to US$268.7m. EPS estimate increased from US$1.90 to US$2.20 per share. Net income forecast to grow 52% next year vs 9.8% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price was steady at US$155 over the past week. お知らせ • Apr 28
Krystal Biotech, Inc. to Report Q1, 2024 Results on May 06, 2024 Krystal Biotech, Inc. announced that they will report Q1, 2024 results at 9:30 AM, US Eastern Standard Time on May 06, 2024 お知らせ • Apr 23
Krystal Biotech, Inc Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the Lung Krystal Biotech, Inc. announced that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung, for the treatment of patients with locally advanced or metastatic solid tumors of the lung. The KYANITE-1 clinical trial is an open-label, multicenter, dose escalation and expansion study to evaluate inhaled KB707 monotherapy in patients with advanced solid tumor malignancies affecting the lungs. Details of the KYANITE-1 study can be found at www.clinicaltrials.gov under NCT identifier: NCT06228326. In February 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. This is the second Fast Track Designation for the KB707 program. In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-PD-1 relapsed/refractory locally advanced or metastatic melanoma. IL-2 and IL-12 are secreted cytokines with complementary functions promoting cell-mediated immunity in humans. Both IL-2 and IL-12 have been shown to elicit anti-tumor immune responses in preclinical models and in clinical settings and have been extensively studied for their potential in cancer immunotherapy. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and their inherently short half-lives necessitate high dose levels and extremely frequent dose intervals. KB707 is a modified HSV-1 vector designed to deliver genes encoding both human IL-12 and IL-2 directly to a patient’s tumor(s) and promote systemic immune-mediated tumor clearance. KB707 targets solid tumors that are accessible via intratumoral injection or inhalation. Major Estimate Revision • Apr 16
Consensus EPS estimates increase by 11% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$254.7m to US$261.7m. EPS estimate increased from US$1.75 to US$1.95 per share. Net income forecast to grow 395% next year vs 9.2% decline forecast for Biotechs industry in the US. Consensus price target broadly unchanged at US$189. Share price fell 5.4% to US$170 over the past week. お知らせ • Apr 05
Krystal Biotech, Inc., Annual General Meeting, May 17, 2024 Krystal Biotech, Inc., Annual General Meeting, May 17, 2024, at 16:00 US Eastern Standard Time. Agenda: To elect the three Class I director nominees named in the Proxy Statement; to ratify the appointment of KPMG LLP as company's independent registered public accounting firm for company's fiscal year ending December 31, 2024; to consider and act upon a non-binding, advisory vote on the compensation of company's named executive officers; and to transact such other business as may properly come before the Annual Meeting or any adjournment(s) or postponement(s) of the Annual Meeting. Recent Insider Transactions Derivative • Mar 13
Founder notifies of intention to sell stock Krish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of March. If the sale is conducted around the recent share price of US$172, it would amount to US$4.3m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2023, Krish's direct individual holding has decreased from 1.73m shares to 1.64m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Feb 28
Executive VP & Chief Accounting Officer notifies of intention to sell stock Kathryn Romano intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of February. If the sale is conducted around the recent share price of US$111, it would amount to US$900k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Feb 27
Price target increased by 14% to US$176 Up from US$154, the current price target is an average from 10 analysts. New target price is approximately in line with last closing price of US$170. Stock is up 108% over the past year. The company is forecast to post earnings per share of US$1.46 for next year compared to US$0.40 last year. New Risk • Feb 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (57% accrual ratio). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (9.8% increase in shares outstanding). Breakeven Date Change • Feb 26
Forecast breakeven date moved forward to 2024 The 8 analysts covering Krystal Biotech previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of US$115.0m in 2024. Average annual earnings growth of 46% is required to achieve expected profit on schedule. お知らせ • Feb 21
Krystal Biotech, Inc. to Report Q4, 2023 Results on Feb 26, 2024 Krystal Biotech, Inc. announced that they will report Q4, 2023 results Pre-Market on Feb 26, 2024 Recent Insider Transactions Derivative • Jan 24
Executive VP & Chief Accounting Officer notifies of intention to sell stock Kathryn Romano intends to sell 3k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of January. If the sale is conducted around the recent share price of US$130, it would amount to US$325k. Since March 2023, Kathryn's direct individual holding has decreased from 15.98k shares to 12.56k. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months. お知らせ • Jan 05
Krystal Biotech Receives Permanent J-Code (J3401) for VYJUVEK® Krystal Biotech, Inc. announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code for VYJUVEK became effective on January 1, 2024. J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional. J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing. VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. Recent Insider Transactions Derivative • Dec 13
Founder notifies of intention to sell stock Krish Krishnan intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of December. If the sale is conducted around the recent share price of US$107, it would amount to US$2.7m. For the year to December 2017, Krish's total compensation was 20% salary and 80% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2022, Krish's direct individual holding has decreased from 1.78m shares to 1.66m. Company insiders have collectively sold US$19m more than they bought, via options and on-market transactions in the last 12 months. お知らせ • Nov 29
Krystal Biotech Announces EMA Validation of Marketing Authorization Application for Vyjuvek for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that the Company's Marketing Authorization Application (MAA) to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review. A CHMP opinion is anticipated in the second half of 2024. In September 2023, Krystal Biotech received a positive opinion from the EMA Pediatric Committee on the Pediatric Investment Plan for VYJUVE K for the treatment of DEB. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or <URL> Contraindications: VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours. Major Estimate Revision • Nov 13
Consensus revenue estimates decrease by 11%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$41.4m to US$37.0m. EPS estimate increased from -US$4.15 to -US$0.429 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$151 unchanged from last update. Share price fell 5.0% to US$98.56 over the past week. お知らせ • Oct 31
Krystal Biotech, Inc. to Report Q3, 2023 Results on Nov 06, 2023 Krystal Biotech, Inc. announced that they will report Q3, 2023 results Pre-Market on Nov 06, 2023 Major Estimate Revision • Sep 23
Consensus revenue estimates decrease by 11%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$33.1m to US$29.6m. EPS estimate increased from -US$4.84 to -US$4.50 per share. Biotechs industry in the US expected to see average net income decline 4.0% next year. Consensus price target of US$149 unchanged from last update. Share price fell 4.2% to US$115 over the past week. 
