Krystal Biotech Inc 2024年度报告

Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the SecuritiesYes☐No☐ Act. Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.Yes☐No☐ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file suchreports), 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 submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period thatthe 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, a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes☐No☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of theregistrant included in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-basedcompensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☐ The aggregate market value of common stock held by non-affiliates of the registrant, based on the closing sales price for such stockon June 30, 2024 as reported by The Nasdaq Stock Market, was $4.6 billion.The number of shares of registrant’s common stock outstanding as of February 12, 2025 was 28,806,078.Portions of the registrant’s definitive proxy statement relating to its 2025 Annual Meeting of Stockholders are incorporated byreference into Part III of this report where indicated. Such proxy statement will be filed with the U.S. Securities and ExchangeCommission within 120 days after the end of the fiscal year to which this report relates. Table of Contents PART I Item 1.Business4Item 1A.Risk Factors30Item 1B.Unresolved Staff Comments68Item 1C.Cybersecurity68Item 2.Properties69Item 3.Legal Proceedings69Item 4.Mine Safety Disclosures69 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters andIssuer Purchases of Equity Securities70Item 6.[Reserved]72Item 7.Management’s Discussion and Analysis of Financial Condition and Resultsof Operations72Item 7A.Quantitative and Qualitative Disclosures About Market Risk86Item 8.Financial Statements and Supplementary DataF-1Item 9.Changes in and Disagreements with Accountants on Accounting andFinancial Disclosure110Item 9A.Controls and Procedures110Item 9B.Other Information112Item 9C.Disclosure Regarding Foreign Jurisdiction that Prevent Inspections112 PART III Item 10.Directors, Executive Officers and Corporate Governance112Item 11.Executive Compensation112Item 12.Security Ownership of Certain Beneficial Owners and Management andRelated Stockholder Matters112Item 13.Certain Relationships and Related Transactions, and Director Independence112Item 14.Principal Accountant Fees and Services112 PART IV Item 15.Exhibits and Financial Statement Schedules113Item 16.Form 10-K Summary115 FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains “forward-looking statements” within the meaning ofSection 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of theSecurities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements includeall statements that are not historical facts and can be identified by terms such as “anticipate,” “believe,”“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,”“should,”“target,”“wil