{"success":true,"data":{"pressRelease":{"id":"18657","rtpr_id":"nGNX16zpRs","ticker":"KRYS","exchange":"NASDAQ","all_tickers":["KRYS"],"title":"Krystal Biotech Announces First Quarter 2026 Financial and Operating Results","author":"Globe Newswire","published_at":"2026-05-04T11:00:01.071Z","article_body":"$116.4 million in 1Q VYJUVEK global revenue and $846.7 million since launch\n\nEnrollment complete in KB803 (corneal abrasions in DEB patients)\nregistrational study\n\nOn track for KB803 and KB801 (NK) registrational data readouts in 2026\n\nFDA grants platform technology designation for KB407 (CF) and KB111 (HHD)\n\nStrong balance sheet, ending the quarter with $1.0 billion in cash and\ninvestments\n\nPITTSBURGH, May 04, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the\n“Company”) (NASDAQ: KRYS) today reported financial results for the first\nquarter ending March 31, 2026 and provided a business update.\n\n“Following a successful 2025, we are entering 2026 with strong momentum,\nincluding two potential registrational study readouts and continued global\nexpansion for VYJUVEK,” said Krish S. Krishnan, Chairman and Chief Executive\nOfficer of Krystal Biotech. “With three pipeline products receiving platform\ndesignation, each development milestone strengthens the regulatory dataset,\nwhich could accelerate future programs and potentially reduce development\nrisk. This compounding advantage underscores the value of the platform model\nwe have been building since day one.”\n\nVYJUVEK(®) (beremagene geperpavec-svdt, or B-VEC)\nfor the Treatment of Dystrophic Epidermolysis Bullosa (DEB)\n\nThe Company recorded $116.4 million in VYJUVEK net product revenue for the\nfirst quarter of 2026, an increase of 32% compared to the prior year first\nquarter. Gross margin for the first quarter of 2026 was 95%.\n\nIn the United States, the Company has secured over 695 reimbursement approvals\nfor VYJUVEK and continues to broaden the prescriber base across the country,\nwith over 60 new prescribers in the first quarter of 2026 and over 570 unique\nprescribers since launch. The Company has also launched patient support\ninitiatives that leverage the recent VYJUVEK label update and increased\nadministration flexibility to help DEB patients and their families\nconveniently integrate VYJUVEK into lifelong wound healing routines as their\nstandard of care.\n\nOverseas, the Company estimates that over 140 patients in Germany, France and\nJapan have been prescribed VYJUVEK. Pricing discussions with German and French\nreimbursement authorities are ongoing. The Company expects negotiations to\ncontinue until at least 2H 2026 in Germany and 2027 in France. The Company is\nalso advancing pricing discussions with reimbursement authorities in Italy to\nenable a potential launch in 2H 2026 and recently initiated pricing\ndiscussions with Spanish reimbursement authorities. Based on initial\ninteractions with Spanish authorities, the Company now expects to launch in\nSpain in 2H 2026. The timing of launch in other European jurisdictions will\ndepend on the cadence and outcomes of regulatory interactions and pricing\nnegotiations.\n\nOphthalmology\n\nTwo registrational readouts anticipated in 2026\n\nKB803 for the treatment and prevention of corneal abrasions in DEB patients\n\nThe Company’s registrational, intra-patient, double-blind, decentralized,\nplacebo-controlled study (IOLITE) with crossover design evaluating KB803 for\nthe treatment and prevention of corneal abrasions in DEB patients is now fully\nenrolled. A total of 16 patients have been enrolled in the study. The primary\nefficacy endpoint of IOLITE will be the change in the average number of days\nper month with corneal abrasion symptoms while receiving KB803 versus placebo.\nThe Company estimates that, as enrolled, IOLITE has at least 90% power to\ndetect an effect size of at least 25% reduction in symptom days, allowing for\na dropout rate up to 20%. Powering assumptions are based on the average\nsymptomatic days per month and standard deviation data from subjects enrolled\nin the natural history study who would be eligible for IOLITE. The Company\nexpects to report top-line results in 4Q 2026. Details about the study can be\nfound at www.clinicaltrials.gov under NCT identifier: NCT07016750.\n\nKB801 for the treatment of neurotrophic keratitis (NK)\n\nThe Company continues to enroll in EMERALD-1, the Company’s registrational,\n1:1 randomized, double-masked, multicenter, placebo-controlled study\nevaluating KB801 for the treatment of NK. The Company expects to complete full\nenrollment of 60 patients in EMERALD-1 and announce data before year end.\nDetails about the study can be found at www.clinicaltrials.gov under NCT\nidentifier: NCT06999733.\n\nRespiratory\n\nKB407 for the treatment of cystic fibrosis (CF)\n\nIn April, the United States Food and Drug Administration (FDA) granted\nplatform technology designation to the genetically modified, non-replicating\nherpes simplex virus type 1 viral vector used in KB407, providing the program\nwith the same potential development and manufacturing efficiencies previously\ngranted to KB801\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-receives-fda-platform-technology-designation-hsv).\nPotential benefits of the designation include shortening of preclinical and\nchemistry, manufacturing, and controls (CMC) review cycles during development\nfor follow-on products, creating a compounding regulatory advantage.\n\nBased on interactions with the FDA, the Company is initiating an open label,\nsingle-arm study to evaluate safety of repeat dose KB407 for 24 weeks in five\npatients with CF who are ineligible for, do not tolerate, or do not benefit\nfrom modulator therapy. Dosing is expected to start later this month. Details\nof the study can be found at www.clinicaltrials.gov under NCT identifier:\nNCT05504837. The Company expects to complete enrollment in 2Q 2026 and report\nresults before year end.\n\nConcurrently, the Company is working closely with the FDA and the Cystic\nFibrosis Foundation (CFF) on an innovative registrational study design and\nstatistical analysis plan that explores using prospectively collected natural\nhistory data from the CFF to supplement placebo control data for evaluation of\nKB407 treatment effect. The Company will share the design and associated\nstatistical analysis of the registrational study following alignment with the\nFDA, which is anticipated in 2H 2026, and expects to initiate the\nregistrational study in 2027.\n\nPreviously, in January, the Company announced\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-positive-interim-clinical-update-kb407)\nthe successful delivery and expression of wild-type cystic fibrosis\ntransmembrane conductance regulator protein in the lungs of patients with CF\ntreated with KB407.\n\nKB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease\n\nThe Company continues to enroll in repeat dose Cohort 2B of SERPENTINE-1, the\nCompany’s open label dose escalation study evaluating KB408 in adult\npatients with AATD with a Pi*ZZ or a Pi*ZNull genotype and expects to report\ninterim data for this cohort in 2026. Cohort 2B is designed to evaluate the\nsafety and tolerability of repeat KB408 dosing at the same dose level that was\npreviously\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-initial-clinical-update-rare)\nshown\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-second-quarter-2025-financial-and)\nto safely deliver SERPINA1 to the lungs of AATD patients after a single dose.\nDetails of the study can be found at www.clinicaltrials.gov under NCT\nidentifier NCT06049082.\n\nDermatology\n\nKB111 for the treatment of Hailey-Hailey disease (HHD)\n\nIn April, the FDA also granted platform technology designation to the\ngenetically modified, non-replicating herpes simplex virus type 1 viral vector\nused in KB111, providing the program with the same regulatory efficiencies\navailable for KB801 and KB407. The Company is developing an HHD-specific\nseverity scale necessary for the clinical evaluation of KB111 and expects to\ncomplete scale development and validation in 1H 2026. Later this month, the\nCompany also expects to initiate HALITE-1, an open-label study evaluating the\nsafety of repeat dose KB111, administered once weekly for 12 weeks, in\napproximately seven patients with HHD. The Company expects to report HALITE-1\nstudy results in 2H 2026. The Company also plans to submit the results from\nHALITE-1 along with the registrational study design for discussions with the\nFDA in 2H 2026 to enable a potential registrational study start in 2027.\n\nOncology\n\nInhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)\n\nThe Company is enrolling patients with advanced NSCLC in a dose expansion\ncohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy.\nKYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and\nexpansion study evaluating inhaled KB707, either as monotherapy or in\ncombination, in patients with locally advanced or metastatic solid tumors of\nthe lung. The Company expects to report interim efficacy data and potential\nregistrational study plans later this year. Details of the study can be found\nat www.clinicaltrials.gov under NCT identifier NCT06228326.\n\nIntratumoral KB707 for the treatment of injectable solid tumors\n\nThe Company continues to follow patients previously enrolled in OPAL-1, the\nCompany’s Phase 1/2 open label, multi-center, dose escalation and expansion\nstudy evaluating intratumoral KB707 in patients with locally advanced or\nmetastatic solid tumor malignancies. The Company will update development plans\nfor intratumoral KB707 as additional safety and efficacy data are collected\nfrom the study. Details of the study can be found at www.clinicaltrials.gov\nunder NCT identifier NCT05970497.\n\nAesthetics\n\nKB304 for the treatment of wrinkles of the décolleté\n\nJeune Aesthetics, Inc., a wholly owned subsidiary of the Company, expects to\ninitiate a Phase 2 study of its lead program KB304 in 2027.\n\nFinancial Results for the Three Months Ended March 31, 2026:\n* Product revenue, net totaled $116.4 million and $88.2 million for the three\nmonths ended March 31, 2026 and March 31, 2025, respectively.\n* Cost of goods sold totaled $6.3 million and $5.0 million for the three\nmonths ended March 31, 2026 and March 31, 2025, respectively.\n* Research and development expenses for the three months ended March 31, 2026\nwere $15.3 million, inclusive of $2.2 million of stock-based compensation,\ncompared to $14.3 million, inclusive of stock-based compensation of $2.5\nmillion for the three months ended March 31, 2025.\n* Selling, general, and administrative expenses for the three months ended\nMarch 31, 2026 were $41.0 million, inclusive of stock-based compensation of\n$11.4 million, compared to $32.6 million, inclusive of stock-based\ncompensation of $11.0 million, for the three months ended March 31, 2025.\n* Net income for the three months ended March 31, 2026 was $55.9 million, or\n$1.91 per common share (basic) and $1.83 per common share (diluted). Net\nincome for the three months ended March 31, 2025 was $35.7 million, or $1.24\nper common share (basic) and $1.20 per common share (diluted).\n* For additional information on the Company’s financial results for the\nthree months ended March 31, 2026, please refer to the Form 10-Q filed with\nthe SEC.\nFinancial Guidance\n\n ($ in millions)                                                                                                     FY 2026 Guidance  \n Non-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense ((1))            $175.0 - $195.0   \n\n(1) Refer to Non-GAAP Financial Measures section below for additional\ninformation. Non-GAAP combined R&D and SG&A expense guidance does not include\nstock-based compensation as we are currently unable to confidently estimate\nFull Year 2026 stock-based compensation expense. As such, we have not provided\na reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and\nSG&A Expense in the above. This could materially affect the calculation of\nforward-looking GAAP combined R&D and SG&A Expense as it is inherently\nuncertain.\n\nConference Call\n\nThe Company will host an investor webcast on May 4, 2026, at 8:30 am ET.\n\nInvestors and the general public can access the live webcast at:\nhttps://www.webcaster5.com/Webcast/Page/3018/53916.\n\nFor those unable to listen to the live conference call, a replay will be\navailable for 30 days on the Investors section of the Company’s website at\nwww.krystalbio.com.\n\nAbout VYJUVEK\n\nVYJUVEK is a non-invasive, topical, redosable genetic medicine designed to\ndeliver two copies of the COL7A1 gene when applied directly to DEB wounds.\nVYJUVEK was designed to treat DEB at the molecular level by providing the\npatient’s skin cells the template to make normal COL7 protein, thereby\naddressing the fundamental disease-causing mechanism. VYJUVEK is approved in\nthe United States, Europe, and Japan.\n\nU.S. INDICATION\n\nVYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy\nindicated for the treatment of wounds in adult and pediatric patients with\ndystrophic epidermolysis bullosa with mutation(s) in the collagen type VII\nalpha 1 chain (COL7A1) gene.\n\nIMPORTANT SAFETY INFORMATION\n\nAdverse Reactions\n\nThe most common adverse drug reactions (incidence >5%) were itching, chills,\nredness, rash, cough, and runny nose. These are not all the possible side\neffects with VYJUVEK. Call your healthcare provider for medical advice about\nside effects.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at\n1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.\n\nContraindications\n\nNone.\n\nWarnings and Precautions\n\nVYJUVEK gel may be applied by a healthcare provider, a caregiver, or the\npatient.\n\nAfter treatment, patients and caregivers should be careful not to touch\ntreated wounds and dressings until the next dressing change.\n\nWash hands and wear protective gloves when changing wound dressings. Disinfect\nbandages from the first dressing change with a virucidal agent, and dispose of\nthe disinfected bandages in a separate sealed plastic bag in household waste.\nDispose of the subsequent used dressings in a sealed plastic bag in household\nwaste.\n\nPatients should avoid touching or scratching wound sites or wound dressings.\n\nIn the event of an accidental exposure flush with clean water for at least 15\nminutes.\n\nFor more information, see full U.S. Prescribing Information\n(https://www.krystallabel.com/pdf/vyjuvek-us-pi.pdf).\n\nAbout Krystal Biotech, Inc.\n\nKrystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage,\nglobal biotechnology company focused on the discovery, development and\ncommercialization of genetic medicines to treat diseases with high unmet\nmedical needs. VYJUVEK(®), the Company’s first commercial product, is the\nfirst-ever redosable gene therapy and the first genetic medicine approved in\nthe United States, Europe, and Japan for the treatment of dystrophic\nepidermolysis bullosa. The Company is rapidly advancing a robust preclinical\nand clinical pipeline of investigational genetic medicines. Krystal Biotech is\nheadquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn\nmore or follow us on LinkedIn\n(https://www.linkedin.com/company/krystal-biotech-inc/) and X\n(https://x.com/KrystalBiotech).\n\nAbout Jeune Aesthetics, Inc.\n\nJeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is\na biotechnology company leveraging a clinically validated gene delivery\nplatform to develop products to fundamentally address – and reverse – the\nbiology of aging and/or damaged skin. For more information, please visit\nhttp://www.jeuneinc.com.\n\nForward-Looking Statements\n\nStatements in this press release about future expectations, plans, and\nprospects, as well as statements that are not historical facts, including\nstatements about, among other topics, our combined R&D and SG&A expense\nguidance; our commercial launch of VYJUVEK in the U.S., Europe, and Japan,\nincluding our expectations regarding timing of pricing discussions in Germany\nand France and pricing discussions with the reimbursement authorities in Italy\nand Spain and potential commercial launches in those countries in 2H 2026; and\nour expectations for our product pipeline, including our clinical trial plans,\nenrollment in our clinical trials, the timing of development and validation of\nan HHD-specific evaluation scale, and the timing of discussions with the FDA\nand data read-outs from our clinical trials may constitute forward-looking\nstatements within the meaning of The Private Securities Litigation Reform Act\nof 1995. Undue reliance should not be placed on the forward-looking statements\nin this press release. These statements are not guaranties of future\nperformance and actual results may differ materially from those indicated by\nsuch forward-looking statements as a result of various important factors,\nincluding uncertainties associated with regulatory review of clinical trials\nand applications for marketing approvals; the availability and commercial\npotential of VYJUVEK or our product candidates; and such other important\nfactors as are set forth under the caption “Risk Factors” in the\nCompany’s annual and quarterly reports on file with the U.S. Securities and\nExchange Commission. The Company is providing the information in this press\nrelease as of the date hereof and undertakes no duty to update this\ninformation unless required by law.\n\nNon-GAAP Financial Measures\n\nThis press release includes forward-looking combined R&D and SG&A expense\nguidance that is not required by, or presented in accordance with, U.S. GAAP\nand should not be considered as an alternative to R&D and SG&A expense or any\nother performance measure derived in accordance with GAAP. The Company defines\nnon-GAAP combined R&D and SG&A expense as GAAP combined R&D and SG&A expense\nexcluding stock-based compensation expense. The Company cautions investors\nthat amounts presented in accordance with its definition of non-GAAP combined\nR&D and SG&A expense may not be comparable to similar measures disclosed by\ncompetitors because not all companies calculate this non-GAAP financial\nmeasure in the same manner. The Company presents this non-GAAP financial\nmeasure because it considers this measure to be an important supplemental\nmeasure and believes it is frequently used by securities analysts, investors,\nand other interested parties in the evaluation of companies in the Company’s\nindustry. Management believes that investors’ understanding of the\nCompany’s performance is enhanced by including this forward-looking non-GAAP\nfinancial measure as a reasonable basis for comparing the Company’s ongoing\nresults of operations. Management uses this non-GAAP financial measure for\nplanning purposes, including the preparation of the Company’s internal\nannual operating budget and financial projections; to evaluate the performance\nand effectiveness of the Company’s operational strategies; and to evaluate\nthe Company’s capacity to expand its business. This non-GAAP financial\nmeasure has limitations as an analytical tool, and should not be considered in\nisolation, or as an alternative to, or a substitute for R&D and SG&A expense\nor other financial statement data presented in accordance with GAAP in the\nCompany’s consolidated financial statements. The Company has not provided a\nquantitative reconciliation of forecasted non-GAAP combined R&D and SG&A\nexpense to forecasted GAAP combined R&D and SG&A expense because the Company\nis unable, without making unreasonable efforts, to calculate the reconciling\nitem, stock-based compensation expenses, with confidence. This item, which\ncould materially affect the computation of forward-looking GAAP combined R&D\nand SG&A expense, is inherently uncertain and depends on various factors, some\nof which are outside of the Company’s control.\n\nCONTACT\n\nInvestors and Media:\n\nStéphane Paquette, PhD\n\nKrystal Biotech\n\nspaquette@krystalbio.com\n\nCondensed Consolidated Balance Sheet Data:\n\n                               March 31, 2026         December 31, 2025     \n (in thousands)                (unaudited)                                  \n Balance sheet data:                                                        \n Cash and cash equivalents     $         501,313      $          496,304    \n Short-term investments                  322,092                 331,487    \n Long-term investments                   193,485                 128,066    \n Total assets                            1,396,967               1,333,794  \n Total liabilities                       120,238                 114,234    \n Total stockholders’ equity    $         1,276,729    $          1,219,560  \n                                                                            \n\nCondensed Consolidated Statements of Operations:\n\n                                              Three Months Ended March 31,                                        \n                                                     2026                          2025             Change        \n (in thousands, except per share data)        (unaudited)                                                         \n Revenue                                                                                                          \n Product revenue, net                         $      116,357                $      88,183           $     28,174  \n Operating Expenses                                                                                               \n Cost of goods sold                                  6,323                         5,028                  1,295   \n Research and development                            15,331                        14,256                 1,075   \n Selling, general, and administrative                41,014                        32,647                 8,367   \n Total operating expenses                            62,668                        51,931                 10,737  \n Income from operations                              53,689                        36,252                 17,437  \n Other income                                                                                                     \n Interest and other income, net                      7,753                         7,345                  408     \n Income before income taxes                          61,442                        43,597                 17,845  \n Income tax expense                                  (5,510   )                    (7,864  )              2,354   \n Net income                                   $      55,932                 $      35,733           $     20,199  \n                                                                                                                  \n Net income per common share:                                                                                     \n Basic                                        $      1.91                   $      1.24                           \n Diluted                                      $      1.83                   $      1.20                           \n                                                                                                                  \n Weighted-average common shares outstanding:                                                                      \n Basic                                               29,288                        28,815                         \n Diluted                                             30,507                        29,871                         \n                                                                                                                  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/94ec1f39-c0eb-4e65-9d7e-250519ef03f4)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX16zpRs","title":"Krystal Biotech Announces First Quarter 2026 Financial and Operating Results","author":"Globe Newswire","ticker":"KRYS","created":"2026-05-04T11:00:01.071Z","tickers":["KRYS"],"exchange":"NASDAQ","article_body":"$116.4 million in 1Q VYJUVEK global revenue and $846.7 million since launch\n\nEnrollment complete in KB803 (corneal abrasions in DEB patients)\nregistrational study\n\nOn track for KB803 and KB801 (NK) registrational data readouts in 2026\n\nFDA grants platform technology designation for KB407 (CF) and KB111 (HHD)\n\nStrong balance sheet, ending the quarter with $1.0 billion in cash and\ninvestments\n\nPITTSBURGH, May 04, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the\n“Company”) (NASDAQ: KRYS) today reported financial results for the first\nquarter ending March 31, 2026 and provided a business update.\n\n“Following a successful 2025, we are entering 2026 with strong momentum,\nincluding two potential registrational study readouts and continued global\nexpansion for VYJUVEK,” said Krish S. Krishnan, Chairman and Chief Executive\nOfficer of Krystal Biotech. “With three pipeline products receiving platform\ndesignation, each development milestone strengthens the regulatory dataset,\nwhich could accelerate future programs and potentially reduce development\nrisk. This compounding advantage underscores the value of the platform model\nwe have been building since day one.”\n\nVYJUVEK(®) (beremagene geperpavec-svdt, or B-VEC)\nfor the Treatment of Dystrophic Epidermolysis Bullosa (DEB)\n\nThe Company recorded $116.4 million in VYJUVEK net product revenue for the\nfirst quarter of 2026, an increase of 32% compared to the prior year first\nquarter. Gross margin for the first quarter of 2026 was 95%.\n\nIn the United States, the Company has secured over 695 reimbursement approvals\nfor VYJUVEK and continues to broaden the prescriber base across the country,\nwith over 60 new prescribers in the first quarter of 2026 and over 570 unique\nprescribers since launch. The Company has also launched patient support\ninitiatives that leverage the recent VYJUVEK label update and increased\nadministration flexibility to help DEB patients and their families\nconveniently integrate VYJUVEK into lifelong wound healing routines as their\nstandard of care.\n\nOverseas, the Company estimates that over 140 patients in Germany, France and\nJapan have been prescribed VYJUVEK. Pricing discussions with German and French\nreimbursement authorities are ongoing. The Company expects negotiations to\ncontinue until at least 2H 2026 in Germany and 2027 in France. The Company is\nalso advancing pricing discussions with reimbursement authorities in Italy to\nenable a potential launch in 2H 2026 and recently initiated pricing\ndiscussions with Spanish reimbursement authorities. Based on initial\ninteractions with Spanish authorities, the Company now expects to launch in\nSpain in 2H 2026. The timing of launch in other European jurisdictions will\ndepend on the cadence and outcomes of regulatory interactions and pricing\nnegotiations.\n\nOphthalmology\n\nTwo registrational readouts anticipated in 2026\n\nKB803 for the treatment and prevention of corneal abrasions in DEB patients\n\nThe Company’s registrational, intra-patient, double-blind, decentralized,\nplacebo-controlled study (IOLITE) with crossover design evaluating KB803 for\nthe treatment and prevention of corneal abrasions in DEB patients is now fully\nenrolled. A total of 16 patients have been enrolled in the study. The primary\nefficacy endpoint of IOLITE will be the change in the average number of days\nper month with corneal abrasion symptoms while receiving KB803 versus placebo.\nThe Company estimates that, as enrolled, IOLITE has at least 90% power to\ndetect an effect size of at least 25% reduction in symptom days, allowing for\na dropout rate up to 20%. Powering assumptions are based on the average\nsymptomatic days per month and standard deviation data from subjects enrolled\nin the natural history study who would be eligible for IOLITE. The Company\nexpects to report top-line results in 4Q 2026. Details about the study can be\nfound at www.clinicaltrials.gov under NCT identifier: NCT07016750.\n\nKB801 for the treatment of neurotrophic keratitis (NK)\n\nThe Company continues to enroll in EMERALD-1, the Company’s registrational,\n1:1 randomized, double-masked, multicenter, placebo-controlled study\nevaluating KB801 for the treatment of NK. The Company expects to complete full\nenrollment of 60 patients in EMERALD-1 and announce data before year end.\nDetails about the study can be found at www.clinicaltrials.gov under NCT\nidentifier: NCT06999733.\n\nRespiratory\n\nKB407 for the treatment of cystic fibrosis (CF)\n\nIn April, the United States Food and Drug Administration (FDA) granted\nplatform technology designation to the genetically modified, non-replicating\nherpes simplex virus type 1 viral vector used in KB407, providing the program\nwith the same potential development and manufacturing efficiencies previously\ngranted to KB801\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-receives-fda-platform-technology-designation-hsv).\nPotential benefits of the designation include shortening of preclinical and\nchemistry, manufacturing, and controls (CMC) review cycles during development\nfor follow-on products, creating a compounding regulatory advantage.\n\nBased on interactions with the FDA, the Company is initiating an open label,\nsingle-arm study to evaluate safety of repeat dose KB407 for 24 weeks in five\npatients with CF who are ineligible for, do not tolerate, or do not benefit\nfrom modulator therapy. Dosing is expected to start later this month. Details\nof the study can be found at www.clinicaltrials.gov under NCT identifier:\nNCT05504837. The Company expects to complete enrollment in 2Q 2026 and report\nresults before year end.\n\nConcurrently, the Company is working closely with the FDA and the Cystic\nFibrosis Foundation (CFF) on an innovative registrational study design and\nstatistical analysis plan that explores using prospectively collected natural\nhistory data from the CFF to supplement placebo control data for evaluation of\nKB407 treatment effect. The Company will share the design and associated\nstatistical analysis of the registrational study following alignment with the\nFDA, which is anticipated in 2H 2026, and expects to initiate the\nregistrational study in 2027.\n\nPreviously, in January, the Company announced\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-positive-interim-clinical-update-kb407)\nthe successful delivery and expression of wild-type cystic fibrosis\ntransmembrane conductance regulator protein in the lungs of patients with CF\ntreated with KB407.\n\nKB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease\n\nThe Company continues to enroll in repeat dose Cohort 2B of SERPENTINE-1, the\nCompany’s open label dose escalation study evaluating KB408 in adult\npatients with AATD with a Pi*ZZ or a Pi*ZNull genotype and expects to report\ninterim data for this cohort in 2026. Cohort 2B is designed to evaluate the\nsafety and tolerability of repeat KB408 dosing at the same dose level that was\npreviously\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-initial-clinical-update-rare)\nshown\n(https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-second-quarter-2025-financial-and)\nto safely deliver SERPINA1 to the lungs of AATD patients after a single dose.\nDetails of the study can be found at www.clinicaltrials.gov under NCT\nidentifier NCT06049082.\n\nDermatology\n\nKB111 for the treatment of Hailey-Hailey disease (HHD)\n\nIn April, the FDA also granted platform technology designation to the\ngenetically modified, non-replicating herpes simplex virus type 1 viral vector\nused in KB111, providing the program with the same regulatory efficiencies\navailable for KB801 and KB407. The Company is developing an HHD-specific\nseverity scale necessary for the clinical evaluation of KB111 and expects to\ncomplete scale development and validation in 1H 2026. Later this month, the\nCompany also expects to initiate HALITE-1, an open-label study evaluating the\nsafety of repeat dose KB111, administered once weekly for 12 weeks, in\napproximately seven patients with HHD. The Company expects to report HALITE-1\nstudy results in 2H 2026. The Company also plans to submit the results from\nHALITE-1 along with the registrational study design for discussions with the\nFDA in 2H 2026 to enable a potential registrational study start in 2027.\n\nOncology\n\nInhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)\n\nThe Company is enrolling patients with advanced NSCLC in a dose expansion\ncohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy.\nKYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and\nexpansion study evaluating inhaled KB707, either as monotherapy or in\ncombination, in patients with locally advanced or metastatic solid tumors of\nthe lung. The Company expects to report interim efficacy data and potential\nregistrational study plans later this year. Details of the study can be found\nat www.clinicaltrials.gov under NCT identifier NCT06228326.\n\nIntratumoral KB707 for the treatment of injectable solid tumors\n\nThe Company continues to follow patients previously enrolled in OPAL-1, the\nCompany’s Phase 1/2 open label, multi-center, dose escalation and expansion\nstudy evaluating intratumoral KB707 in patients with locally advanced or\nmetastatic solid tumor malignancies. The Company will update development plans\nfor intratumoral KB707 as additional safety and efficacy data are collected\nfrom the study. Details of the study can be found at www.clinicaltrials.gov\nunder NCT identifier NCT05970497.\n\nAesthetics\n\nKB304 for the treatment of wrinkles of the décolleté\n\nJeune Aesthetics, Inc., a wholly owned subsidiary of the Company, expects to\ninitiate a Phase 2 study of its lead program KB304 in 2027.\n\nFinancial Results for the Three Months Ended March 31, 2026:\n* Product revenue, net totaled $116.4 million and $88.2 million for the three\nmonths ended March 31, 2026 and March 31, 2025, respectively.\n* Cost of goods sold totaled $6.3 million and $5.0 million for the three\nmonths ended March 31, 2026 and March 31, 2025, respectively.\n* Research and development expenses for the three months ended March 31, 2026\nwere $15.3 million, inclusive of $2.2 million of stock-based compensation,\ncompared to $14.3 million, inclusive of stock-based compensation of $2.5\nmillion for the three months ended March 31, 2025.\n* Selling, general, and administrative expenses for the three months ended\nMarch 31, 2026 were $41.0 million, inclusive of stock-based compensation of\n$11.4 million, compared to $32.6 million, inclusive of stock-based\ncompensation of $11.0 million, for the three months ended March 31, 2025.\n* Net income for the three months ended March 31, 2026 was $55.9 million, or\n$1.91 per common share (basic) and $1.83 per common share (diluted). Net\nincome for the three months ended March 31, 2025 was $35.7 million, or $1.24\nper common share (basic) and $1.20 per common share (diluted).\n* For additional information on the Company’s financial results for the\nthree months ended March 31, 2026, please refer to the Form 10-Q filed with\nthe SEC.\nFinancial Guidance\n\n ($ in millions)                                                                                                     FY 2026 Guidance  \n Non-GAAP Research and Development (“R&D”) and Selling, General and Administrative (“SG&A”) expense ((1))            $175.0 - $195.0   \n\n(1) Refer to Non-GAAP Financial Measures section below for additional\ninformation. Non-GAAP combined R&D and SG&A expense guidance does not include\nstock-based compensation as we are currently unable to confidently estimate\nFull Year 2026 stock-based compensation expense. As such, we have not provided\na reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and\nSG&A Expense in the above. This could materially affect the calculation of\nforward-looking GAAP combined R&D and SG&A Expense as it is inherently\nuncertain.\n\nConference Call\n\nThe Company will host an investor webcast on May 4, 2026, at 8:30 am ET.\n\nInvestors and the general public can access the live webcast at:\nhttps://www.webcaster5.com/Webcast/Page/3018/53916.\n\nFor those unable to listen to the live conference call, a replay will be\navailable for 30 days on the Investors section of the Company’s website at\nwww.krystalbio.com.\n\nAbout VYJUVEK\n\nVYJUVEK is a non-invasive, topical, redosable genetic medicine designed to\ndeliver two copies of the COL7A1 gene when applied directly to DEB wounds.\nVYJUVEK was designed to treat DEB at the molecular level by providing the\npatient’s skin cells the template to make normal COL7 protein, thereby\naddressing the fundamental disease-causing mechanism. VYJUVEK is approved in\nthe United States, Europe, and Japan.\n\nU.S. INDICATION\n\nVYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy\nindicated for the treatment of wounds in adult and pediatric patients with\ndystrophic epidermolysis bullosa with mutation(s) in the collagen type VII\nalpha 1 chain (COL7A1) gene.\n\nIMPORTANT SAFETY INFORMATION\n\nAdverse Reactions\n\nThe most common adverse drug reactions (incidence >5%) were itching, chills,\nredness, rash, cough, and runny nose. These are not all the possible side\neffects with VYJUVEK. Call your healthcare provider for medical advice about\nside effects.\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at\n1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.\n\nContraindications\n\nNone.\n\nWarnings and Precautions\n\nVYJUVEK gel may be applied by a healthcare provider, a caregiver, or the\npatient.\n\nAfter treatment, patients and caregivers should be careful not to touch\ntreated wounds and dressings until the next dressing change.\n\nWash hands and wear protective gloves when changing wound dressings. Disinfect\nbandages from the first dressing change with a virucidal agent, and dispose of\nthe disinfected bandages in a separate sealed plastic bag in household waste.\nDispose of the subsequent used dressings in a sealed plastic bag in household\nwaste.\n\nPatients should avoid touching or scratching wound sites or wound dressings.\n\nIn the event of an accidental exposure flush with clean water for at least 15\nminutes.\n\nFor more information, see full U.S. Prescribing Information\n(https://www.krystallabel.com/pdf/vyjuvek-us-pi.pdf).\n\nAbout Krystal Biotech, Inc.\n\nKrystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage,\nglobal biotechnology company focused on the discovery, development and\ncommercialization of genetic medicines to treat diseases with high unmet\nmedical needs. VYJUVEK(®), the Company’s first commercial product, is the\nfirst-ever redosable gene therapy and the first genetic medicine approved in\nthe United States, Europe, and Japan for the treatment of dystrophic\nepidermolysis bullosa. The Company is rapidly advancing a robust preclinical\nand clinical pipeline of investigational genetic medicines. Krystal Biotech is\nheadquartered in Pittsburgh, Pennsylvania. Visit www.krystalbio.com to learn\nmore or follow us on LinkedIn\n(https://www.linkedin.com/company/krystal-biotech-inc/) and X\n(https://x.com/KrystalBiotech).\n\nAbout Jeune Aesthetics, Inc.\n\nJeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is\na biotechnology company leveraging a clinically validated gene delivery\nplatform to develop products to fundamentally address – and reverse – the\nbiology of aging and/or damaged skin. For more information, please visit\nhttp://www.jeuneinc.com.\n\nForward-Looking Statements\n\nStatements in this press release about future expectations, plans, and\nprospects, as well as statements that are not historical facts, including\nstatements about, among other topics, our combined R&D and SG&A expense\nguidance; our commercial launch of VYJUVEK in the U.S., Europe, and Japan,\nincluding our expectations regarding timing of pricing discussions in Germany\nand France and pricing discussions with the reimbursement authorities in Italy\nand Spain and potential commercial launches in those countries in 2H 2026; and\nour expectations for our product pipeline, including our clinical trial plans,\nenrollment in our clinical trials, the timing of development and validation of\nan HHD-specific evaluation scale, and the timing of discussions with the FDA\nand data read-outs from our clinical trials may constitute forward-looking\nstatements within the meaning of The Private Securities Litigation Reform Act\nof 1995. Undue reliance should not be placed on the forward-looking statements\nin this press release. These statements are not guaranties of future\nperformance and actual results may differ materially from those indicated by\nsuch forward-looking statements as a result of various important factors,\nincluding uncertainties associated with regulatory review of clinical trials\nand applications for marketing approvals; the availability and commercial\npotential of VYJUVEK or our product candidates; and such other important\nfactors as are set forth under the caption “Risk Factors” in the\nCompany’s annual and quarterly reports on file with the U.S. Securities and\nExchange Commission. The Company is providing the information in this press\nrelease as of the date hereof and undertakes no duty to update this\ninformation unless required by law.\n\nNon-GAAP Financial Measures\n\nThis press release includes forward-looking combined R&D and SG&A expense\nguidance that is not required by, or presented in accordance with, U.S. GAAP\nand should not be considered as an alternative to R&D and SG&A expense or any\nother performance measure derived in accordance with GAAP. The Company defines\nnon-GAAP combined R&D and SG&A expense as GAAP combined R&D and SG&A expense\nexcluding stock-based compensation expense. The Company cautions investors\nthat amounts presented in accordance with its definition of non-GAAP combined\nR&D and SG&A expense may not be comparable to similar measures disclosed by\ncompetitors because not all companies calculate this non-GAAP financial\nmeasure in the same manner. The Company presents this non-GAAP financial\nmeasure because it considers this measure to be an important supplemental\nmeasure and believes it is frequently used by securities analysts, investors,\nand other interested parties in the evaluation of companies in the Company’s\nindustry. Management believes that investors’ understanding of the\nCompany’s performance is enhanced by including this forward-looking non-GAAP\nfinancial measure as a reasonable basis for comparing the Company’s ongoing\nresults of operations. Management uses this non-GAAP financial measure for\nplanning purposes, including the preparation of the Company’s internal\nannual operating budget and financial projections; to evaluate the performance\nand effectiveness of the Company’s operational strategies; and to evaluate\nthe Company’s capacity to expand its business. This non-GAAP financial\nmeasure has limitations as an analytical tool, and should not be considered in\nisolation, or as an alternative to, or a substitute for R&D and SG&A expense\nor other financial statement data presented in accordance with GAAP in the\nCompany’s consolidated financial statements. The Company has not provided a\nquantitative reconciliation of forecasted non-GAAP combined R&D and SG&A\nexpense to forecasted GAAP combined R&D and SG&A expense because the Company\nis unable, without making unreasonable efforts, to calculate the reconciling\nitem, stock-based compensation expenses, with confidence. This item, which\ncould materially affect the computation of forward-looking GAAP combined R&D\nand SG&A expense, is inherently uncertain and depends on various factors, some\nof which are outside of the Company’s control.\n\nCONTACT\n\nInvestors and Media:\n\nStéphane Paquette, PhD\n\nKrystal Biotech\n\nspaquette@krystalbio.com\n\nCondensed Consolidated Balance Sheet Data:\n\n                               March 31, 2026         December 31, 2025     \n (in thousands)                (unaudited)                                  \n Balance sheet data:                                                        \n Cash and cash equivalents     $         501,313      $          496,304    \n Short-term investments                  322,092                 331,487    \n Long-term investments                   193,485                 128,066    \n Total assets                            1,396,967               1,333,794  \n Total liabilities                       120,238                 114,234    \n Total stockholders’ equity    $         1,276,729    $          1,219,560  \n                                                                            \n\nCondensed Consolidated Statements of Operations:\n\n                                              Three Months Ended March 31,                                        \n                                                     2026                          2025             Change        \n (in thousands, except per share data)        (unaudited)                                                         \n Revenue                                                                                                          \n Product revenue, net                         $      116,357                $      88,183           $     28,174  \n Operating Expenses                                                                                               \n Cost of goods sold                                  6,323                         5,028                  1,295   \n Research and development                            15,331                        14,256                 1,075   \n Selling, general, and administrative                41,014                        32,647                 8,367   \n Total operating expenses                            62,668                        51,931                 10,737  \n Income from operations                              53,689                        36,252                 17,437  \n Other income                                                                                                     \n Interest and other income, net                      7,753                         7,345                  408     \n Income before income taxes                          61,442                        43,597                 17,845  \n Income tax expense                                  (5,510   )                    (7,864  )              2,354   \n Net income                                   $      55,932                 $      35,733           $     20,199  \n                                                                                                                  \n Net income per common share:                                                                                     \n Basic                                        $      1.91                   $      1.24                           \n Diluted                                      $      1.83                   $      1.20                           \n                                                                                                                  \n Weighted-average common shares outstanding:                                                                      \n Basic                                               29,288                        28,815                         \n Diluted                                             30,507                        29,871                         \n                                                                                                                  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/94ec1f39-c0eb-4e65-9d7e-250519ef03f4)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-04T11:00:01.129394316Z","server_sent_at_ms":1777892401129},"received_at":"2026-05-04T11:00:01.200Z","source_url":"https://www.globenewswire.com/news-release/2026/04/21/3277831/0/en/krystal-biotech-to-report-first-quarter-2026-financial-results-on-may-4-2026.html"},"analysis":{"id":"13437","press_release_id":"18657","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"earnings","narrative":"Krystal Biotech reported a strong first quarter with VYJUVEK revenue increasing 32% year-over-year to $116.4 million and net income rising 57% to $55.9 million.\n\nThe company ended the quarter with $1.0 billion in cash and investments, supporting continued global expansion and R&D investment across its pipeline.\n\nKey operational milestones include full enrollment in the KB803 registrational study and expected 2026 data readouts for both KB803 and KB801, alongside new FDA platform designations for KB407 and KB111.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"VYJUVEK growth accelerates to 32% with $1B cash enabling a deep pipeline of potential 2026 catalysts."},"keyFigures":{"eps":1.83,"revenue":116400000,"guidance":"FY 2026 Non-GAAP R&D and SG&A expense $175.0M - $195.0M","revenueYoy":"32%","customDimensions":{"gross_margin":"95%","kb803_enrollment":"fully enrolled (16 patients)","cash_and_investments":"$1.0 billion"}},"quotedText":"With three pipeline products receiving platform designation, each development milestone strengthens the regulatory dataset, which could accelerate future programs and potentially reduce development risk.","namedEntities":{"people":[{"name":"Krish S. Krishnan","role":"Chairman and Chief Executive Officer"},{"name":"Stéphane Paquette","role":"Investors and Media Contact"}],"products":["VYJUVEK","beremagene geperpavec-svdt","B-VEC","KB803","KB801","KB407","KB111","KB408","KB707","KB304"],"companies":[{"name":"Krystal Biotech, Inc.","ticker":"KRYS"},{"name":"Jeune Aesthetics, Inc.","relationship":"wholly owned subsidiary"},{"name":"Cystic Fibrosis Foundation","relationship":"partner"}],"dollarAmounts":[{"amount":"$116.4 million","context":"Q1 2026 VYJUVEK net product revenue"},{"amount":"$846.7 million","context":"VYJUVEK global revenue since launch"},{"amount":"$1.0 billion","context":"cash and investments at end of quarter"},{"amount":"$116.4 million","context":"total net product revenue Q1 2026"},{"amount":"$88.2 million","context":"total net product revenue Q1 2025"},{"amount":"$55.9 million","context":"net income Q1 2026"},{"amount":"$1.83","context":"diluted net income per common share Q1 2026"},{"amount":"$175.0 - $195.0 million","context":"FY 2026 Non-GAAP combined R&D and SG&A expense guidance"}]},"materialImpact":{"score":4,"reasoning":"VYJUVEK revenue grew 32% YoY to $116.4M, significantly outpacing the prior year, and net income jumped 57% to $55.9M. The company also reported a strong cash position of $1.0B and confirmed key pipeline milestones, including full enrollment in the KB803 registrational study and anticipated 2026 data readouts for two major programs."},"tickerRelevance":{"others":[],"primary":"KRYS"},"globalImportance":45,"audienceRelevance":40,"eventTypeSecondary":["guidance_update","clinical_trial"],"importanceComponents":{"tickerTier":"mid-cap","eventGravity":"earnings_beat_and_pipeline_milestones","sectorWeight":"biotech","revenueGrowth":"32%"}},"event_type":"earnings","event_type_secondary":["guidance_update","clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"Krystal Biotech reported a strong first quarter with VYJUVEK revenue increasing 32% year-over-year to $116.4 million and net income rising 57% to $55.9 million.\n\nThe company ended the quarter with $1.0 billion in cash and investments, supporting continued global expansion and R&D investment across its pipeline.\n\nKey operational milestones include full enrollment in the KB803 registrational study and expected 2026 data readouts for both KB803 and KB801, alongside new FDA platform designations for KB407 and KB111.","key_figures":{"eps":1.83,"revenue":116400000,"guidance":"FY 2026 Non-GAAP R&D and SG&A expense $175.0M - $195.0M","revenueYoy":"32%","customDimensions":{"gross_margin":"95%","kb803_enrollment":"fully enrolled (16 patients)","cash_and_investments":"$1.0 billion"}},"named_entities":{"people":[{"name":"Krish S. Krishnan","role":"Chairman and Chief Executive Officer"},{"name":"Stéphane Paquette","role":"Investors and Media Contact"}],"products":["VYJUVEK","beremagene geperpavec-svdt","B-VEC","KB803","KB801","KB407","KB111","KB408","KB707","KB304"],"companies":[{"name":"Krystal Biotech, Inc.","ticker":"KRYS"},{"name":"Jeune Aesthetics, Inc.","relationship":"wholly owned subsidiary"},{"name":"Cystic Fibrosis Foundation","relationship":"partner"}],"dollarAmounts":[{"amount":"$116.4 million","context":"Q1 2026 VYJUVEK net product revenue"},{"amount":"$846.7 million","context":"VYJUVEK global revenue since launch"},{"amount":"$1.0 billion","context":"cash and investments at end of quarter"},{"amount":"$116.4 million","context":"total net product revenue Q1 2026"},{"amount":"$88.2 million","context":"total net product revenue Q1 2025"},{"amount":"$55.9 million","context":"net income Q1 2026"},{"amount":"$1.83","context":"diluted net income per common share Q1 2026"},{"amount":"$175.0 - $195.0 million","context":"FY 2026 Non-GAAP combined R&D and SG&A expense guidance"}]},"model_name":"glm-4.7","prompt_hash":"sha256:a2703c5a1b5285fe","schema_hash":"sha256:1f8af1196c7db48c","created_at":"2026-05-04T11:07:36.892Z","global_importance":45,"audience_relevance":40,"importance_components":{"tickerTier":"mid-cap","eventGravity":"earnings_beat_and_pipeline_milestones","sectorWeight":"biotech","revenueGrowth":"32%"}},"durationMs":34297,"modelName":"glm-4.7"}}