Krystal Biotech Inc 2025年季度报告

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period fromtoCommission file number:001-38210_____________________________________________________ Krystal Biotech, Inc. (Exact name of registrant as specified in its charter)_____________________________________________________ Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. If emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of May1, 2025, there were28,898,680shares of the registrant’s common stock issued and outstanding. PART I. FINANCIAL INFORMATION Item 1.Financial StatementsCondensed Consolidated Balance Sheets as ofMarch31, 2025 (unaudited)andDecember31, 20243Condensed Consolidated Statements of Operations and Comprehensive Income(Loss)for theThreeMonthsEndedMarch31, 2025and2024 (unaudited)4Condensed Consolidated Statements of Stockholders’ Equity for theThreeMonths EndedMarch31, 2025and2024 (unaudited)5Condensed Consolidated Statements of Cash Flows for theThree Months EndedMarch31, 2025and2024(unaudited)6Notes to Condensed Consolidated Financial Statements (unaudited)7Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations17Item 3.Quantitative and Qualitative Disclosures About Market Risk27Item 4.Controls and Procedures28 PART II. OTHER INFORMATION Item 1.Legal Proceedings29Item 1A.Risk Factors29Item 2.Unregistered Sales of Equity Securities and Use of Proceeds69Item 3.Defaults Upon Senior Securities69Item 4.Mine Safety Disclosures69Item 5.Other Information69Item 6.Exhibits69 SIGNATURES Krystal Biotech, Inc.Condensed Consolidated Balance Sheets(unaudited) Krystal Biotech, Inc.Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)(unaudited) Krystal Biotech, Inc.Condensed Consolidated Statements of Stockholders’ Equity(unaudited) The accompanying notes are an integral part of these condensed consolidated financial statements. Krystal Biotech, Inc.Condensed Consolidated Statements of Cash Flows(unaudited) Krystal Biotech, Inc.Notes to Condensed Consolidated Financial Statements(unaudited) 1.Organization Krystal Biotech, Inc. (the “Company,”or“we”or other similar pronouns) commenced operations in April 2016. In March 2017, weconverted from a California limited liability company to a Delaware C-corporation, and changed our name from Krystal Biotech LLC toKrystal Biotech, Inc. In April 2019, we incorporated Jeune Aesthetics, Inc. (“Jeune Aesthetics”), in Delaware, a wholly-owned subsidiary, forthe purpose of undertaking preclinical and clinical studies for aesthetic skin conditions. In January 2022, August 2022, December 2022, August2023, March 2024, November 2024, and December 2024 we incorporated wholly-owned subsidiaries in Switzerland, Netherlands, France,Germany, Japan, Italy, and Spain, respectively, for the purpose of establishing initial operations in Europe and Japan for the commercializationof VYJUVEKand our product pipeline.We are a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development, manufacturing,® and commercialization of genetic medicines to treat diseases with high unmet medical needs. Using our patented gene therapy technologyplatform that is based on engineered herpes simplex virus-1 (“HSV-1”), we create vectors that efficiently deliver therapeutic transgenes to cellsof interest in multiple organ systems. The cell’s own machinery then transcribes and translates the transgene to treat the disease. Our vectors areamenable to formulation for non-invasive or minimally invasive routes of administration at a healthcare professional’s