Krystal Biotech, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Krystal Biotech, Inc. has submitted its 2023 annual report (10-K) detailing its operations and financial standing for the fiscal year ending December 31, 2023.</b>

AI Summary

Krystal Biotech, Inc. (KRYS) filed a Annual Report (10-K) with the SEC on February 26, 2024. Krystal Biotech, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is 2100 Wharton Street, Suite 701, Pittsburgh, PA 15203. Krystal Biotech, Inc. is classified under Standard Industrial Classification 2836: Biological Products (No Diagnostic Substances). The filing was submitted on February 26, 2024.

Why It Matters

For investors and stakeholders tracking Krystal Biotech, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Krystal Biotech's business, financial condition, and results of operations for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information within the filing, including financial statements and risk factors, allows stakeholders to understand the company's strategic direction, potential challenges, and overall health within the biotechnology sector.

Risk Assessment

Risk Level: low — Krystal Biotech, Inc. shows low risk based on this filing. The risk is low as this is a standard annual filing providing historical financial data and business overview, with no immediate negative indicators present in the provided metadata.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K filing to understand Krystal Biotech's performance and strategic outlook for 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of report)
• 2024-02-26 — Filing Date (Date filed)
• 2023-01-01 — Report Start Date (Period of report)

Key Players & Entities

• Krystal Biotech, Inc. (company) — Filer name
• 2100 Wharton Street, Suite 701, Pittsburgh, PA 15203 (company) — Business address
• 2836 (regulator) — Standard Industrial Classification

FAQ

Industry Context

Krystal Biotech operates in the biotechnology sector, focusing on the development and commercialization of novel therapies.

Regulatory Implications

The company is subject to regulatory oversight typical for biotechnology firms, including those related to drug development and approval processes.

What Investors Should Do

1. Analyze Krystal Biotech's financial statements for the fiscal year ended December 31, 2023.
2. Review the business overview and risk factors section of the 10-K to understand operational and market challenges.
3. Assess any disclosures regarding product development pipelines and regulatory milestones.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-26: Filing Date — Date Krystal Biotech, Inc. submitted its 10-K filing.

Year-Over-Year Comparison

This is the initial analysis of the 2023 10-K filing; comparison to prior filings would require access to those documents.

Filing Documents

• krys-20231231.htm (10-K) — 1922KB
• krys-20231231ex211xlistofs.htm (EX-21.1) — 1KB
• krys-20231231ex231xkpmgcon.htm (EX-23.1) — 2KB
• krys-20231231ex232xmhmcons.htm (EX-23.2) — 4KB
• krys-20231231ex311.htm (EX-31.1) — 11KB
• krys-20231231ex312.htm (EX-31.2) — 11KB
• krys-20231231ex321.htm (EX-32.1) — 8KB
• krys-20231231exx971xexecut.htm (EX-97.1) — 28KB
• krys-20231231_g1.jpg (GRAPHIC) — 122KB
• krys-20231231_g2.jpg (GRAPHIC) — 39KB
• 0001711279-24-000005.txt (&nbsp;) — 8254KB
• krys-20231231.xsd (EX-101.SCH) — 48KB
• krys-20231231_cal.xml (EX-101.CAL) — 82KB
• krys-20231231_def.xml (EX-101.DEF) — 180KB
• krys-20231231_lab.xml (EX-101.LAB) — 605KB
• krys-20231231_pre.xml (EX-101.PRE) — 387KB
• krys-20231231_htm.xml (XML) — 1140KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 64 Item 1C. C ybersecurity 65 Item 2.

Properties

Properties 66 Item 3.

Legal Proceedings

Legal Proceedings 66 Item 4. Mine Safety Disclosures 66 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 67 Item 6. [Reserved] 70 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 70 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 83 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data F- 1 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 110 Item 9A.

Controls and Procedures

Controls and Procedures 110 Item 9B. Other Information 112 Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspections 112 PART III Item 10. Directors, Executive Officers and Corporate Governance 112 Item 11.

Executive Compensation

Executive Compensation 112 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 112 Item 13. Certain Relationships and Related Transactions, and Director Independence 112 Item 14. Principal Accountant Fees and Services 112 PART IV Item 15. Exhibits and Financial Statement Schedules 113 Item 16. Form 10-K Summary 115

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements include all 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," "will," "would," or similar expressions and the negatives of those terms. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements appearing in a number of places throughout this Annual Report on Form 10-K include, but are not limited to, statements about the following, among other things: our commercialization plans in the United States for our first commercial product, VYJUVEK (beremagene geperpavec-svdt, or B-VEC; referred to as B-VEC outside the U.S.), which was approved by the United States Food and Drug Administration ("FDA") in May 2023 for the treatment of dystrophic epidermolysis bullosa ("DEB"); our expectations regarding reimbursement of VYJUVEK in the U.S., including coverage determinations and the timing thereof from commercial health plans and Medicaid; the timing, scope and results of our regulatory filings and potential approvals for marketing authorizations for B-VEC in the European Union and Japan, our expectations regarding the timing of completion of our open label extension study of B-VEC in Japanese patients, and our plans and expected timing of commercial launch

Business

Item 1. Business. Overview We are a fully integrated, commercial-stage biotechnology company focused on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Our first commercial product, VYJUVEK , was approved by the FDA on May 19, 2023 for the treatment of DEB, and we subsequently initiated our U.S. commercial launch. VYJUVEK is the first medicine approved by the FDA for the treatment of DEB. Using our patented gene therapy technology platform that is based on engineered HSV-1, we create vectors that efficiently deliver therapeutic transgenes to cells of interest in multiple organ systems. The cell's own machinery then transcribes and translates the encoded effector to treat or prevent disease. We formulate our vectors for non-invasive or minimally invasive routes of administration at a healthcare professional's office or in the patient's home by a healthcare professional. Our goal is to develop easy-to-use medicines to dramatically improve the lives of patients living with rare and serious diseases. Our innovative technology platform is supported by an in-house, FDA-inspected commercial scale Current Good Manufacturing Practice ("CGMP") manufacturing facility and a second, completed and qualified, commercial scale CGMP facility to support future expansion. Our development pipeline includes multiple clinical stage programs for rare and serious diseases, and we are investing in research and development to advance and grow this pipeline. We possess exclusive rights to develop, manufacture, and commercialize our FDA approved product and our pipeline candidates throughout the world. While our focus is on the development of gene therapies to treat patients with severe, lifethreatening, or rare diseases with high unmet medical needs, we are also evaluating the potential of our platform to address more prevalent and/or non-genetic conditions. To that end, in April 2019, we incorporated Jeune Aesthetic

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View this 10-K filing on SEC EDGAR