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Item 9A. Controls and Procedures

2025-02-19 compared with 2024-02-26 · 26 added, 22 removed, 191 unchanged (20% of the section changed)

34 unchanged sentences

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements), and our report dated February 26, 2024 expressed an unqualified opinion on those consolidated financial statements.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2024, and the related notes (collectively, the consolidated financial statements), and our report dated February 19, 2025 expressed an unqualified opinion on those consolidated financial statements.

Basis for Opinion

18 unchanged sentences

Other Information.

Insider Trading Arrangements

On November 18, 2024 , Kathryn Romano , our Chief Accounting Officer , adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act for (1) the exercise of 5,000 stock options and sale of the associated shares of common stock issued to Ms.

Romano until the earlier of execution of all trades or August 20, 2025 , and (2) the sale on February 26, 2025 of up to 750 shares of common stock issued to Ms.

Romano pursuant to the vesting of a RSA award on February 26, 2025.

During the three months ended December 31, 2024, other than mentioned above, none of our directors or officers (as that term is defined by the SEC in Rule 16a-1(f) under the Exchange Act) adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement.

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.

23 unchanged sentences

3.2 Amended and Restated Bylaws of Krystal Biotech, Inc.

(incorporate by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, as filed with the SEC on September 25, 2017)

(incorporate d by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, as filed with the SEC on September 25, 2017 )

4.1 Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Amendment No.

3 unchanged sentences

333-227632), as filed with the SEC on October 1, 2018)

Description of Common Stock (incorporated by reference to Exhibit 4.3 to the Company's Annual Report on Form 10-K, as filed with the SEC on F ebruary 27, 2023)

Description of Common Stock (incorporated by reference to Exhibit 4.3 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 27, 2023)

10.1# Form of Indemnification Agreement by and between Krystal Biotech, Inc.

13 unchanged sentences

Romano (incorporated by reference to Exhibit 10.4 to the Company's Annual Report on Form 10-K, as filed with the SEC on March 1, 2021)

10.5# Executive Employment Agreement, effective May 3, 2021 by and between Krystal Biotech, Inc.

and Andy Orth (incorporated by reference to Exhibit 10.5 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 28, 2022)

Krystal Biotech, Inc.

2 unchanged sentences

333-220085), as filed with the SEC on September 14, 2017)

Number Description

Krystal Biotech, Inc.

10 unchanged sentences

333-220085), as filed with the SEC on September 14, 2017)

Number Description

Lease Agreement, dated as of May 26, 2016, by and between Wharton Lender Associates, L.P.

6 unchanged sentences

333-220085), as filed with the SEC on September 7, 2017)

10.12 Investors’ Rights Agreement, dated as of August 7, 2017, by and among Krystal Biotech, Inc.

and the investors listed on Schedule A thereto (incorporated by reference to Exhibit 10.9 to the Company's Registration Statement on Form S-1 (Reg.

333-220085), as filed with the SEC on August 21, 2017)

10.11 Third amendment to Lease Agreement, dated as of May 31, 2018, by and between Wharton Lender Associate, L.P.

9 unchanged sentences

and Krystal Biotech, Inc.

( incorporated by reference to Exhibit 10.17 to the Company's Annual Report on Form 10-K, as filed with the SEC on F ebruary 2 8 , 202 2 )

(incorporated by reference to Exhibit 10.17 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 28, 2022)

Seventh amendment to Lease Agreement, dated as of May 11, 2021, by and between Wharton Lender Associates, L.P.

and Krystal Biotech, Inc.

(incorporated by reference to Exhibit 10.1 8 to the Company's Annual Report on Form 10-K, as filed with the SEC on F ebruary 28, 2022)

(incorporated by reference to Exhibit 10.18 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 28, 2022)

Eighth amendment to Lease Agreement, dated as of July 21, 2021, by and between Wharton Lender Associates, L.P.

and Krystal Biotech, Inc.

(incorporated by reference to Exhibit 10.1 9 to the Company's Annual Report on Form 10-K, as filed with the SEC on F ebruary 28, 2022)

(incorporated by reference to Exhibit 10.19 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 28, 2022)

Ninth amendment to Lease Agreement, dated as of January 4, 2022, by and between Wharton Lender Associates, L.P.

and Krystal Biotech, Inc.

(incorporated by reference to Exhibit 10.

20 to the Company's Annual Report on Form 10-K, as filed with the SEC on F ebruary 28, 2022)

(incorporated by reference to Exhibit 10.20 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 28, 2022)

Purchase and Sale Agreement, dated January 29, 2021, by and between Krystal Biotech, Inc.

6 unchanged sentences

Form of Time-Based Restricted Stock Unit Award Agreement under the 2017 IPO Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on May 8, 2023)

Form of Performance-Based Restricted Stock Unit Award Agreement under the 2017 IPO Stock Incentive Plan (incorporated by reference to Exhibit 10.

2 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on May 8, 2023)

Form of Performance-Based Restricted Stock Unit Award Agreement under the 2017 IPO Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on May 8, 2023)

Securities Purchase Agreement, by and among Krystal Biotech, Inc.

1 unchanged sentence

Registration Rights Agreement, by and among Krystal Biotech, Inc.

and the institutional investors listed on the signature pages thereto, dated as of May 21, 2023 ( incorporated by reference to Exhibit 10 .

2 to the Company’s Current Report on Form 8-K, as filed with the SEC on May 22, 2023)

16.1 Letter to Securities and Exchange Commission from Mayer Hoffman McCann P.C.

dated May 26, 2022 (incorporated by reference to Exhibit 16.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on May 26, 2022).

and the institutional investors listed on the signature pages thereto, dated as of May 21, 2023 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, as filed with the SEC on May 22, 2023)

Number Description

Krystal Biotech, Inc.

Executive Change in Control Severance Plan , with an ef fective date of August 2, 2024 (incorporated by reference to Exhibit 10.1 to the Company ’ s Quarterly Report on Form 10-Q, as filed with the SEC on August 5, 2024)

First Amendment to the Krystal Biotech, Inc.

2017 IPO Stock Incentive Plan , made and en tered into effective as of August 2, 2024 (incorporated by reference to Exhibit 10.

2 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on August 5, 2024)

Twelfth A mendment to Lease Agreement, dated as of September 27, 2024 , by and between Wharton Lender Associates, L.P.

and Krystal Biotech, Inc.

Krystal Biotech, Inc.

Insider Trading Policy and Guidelines for Disclosure of Material Non-Public Information

21.1* Subsidiaries of Krystal Biotech, Inc.

23.1* Consent of KPMG LLP

23.2* Consent of Mayer Hoffman McCann P.C.

31.1* Certification of Periodic Report by Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

2 unchanged sentences

Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Executive Incentive Compensation Recoupment Policy

Executive Incentive Compensation Recoupment Policy , adopted August 4, 2023 ( incorporated by reference to Exhibit 97.1 to the Company's Annual Report on Form 10-K, as filed with the SEC on February 26 , 2024 )

101 (i) XBRL Instance Document, (ii) XBRL Taxonomy Extension Schema Document, (iii) XBRL Taxonomy Extension Calculation Linkbase Document, (iv) XBRL Taxonomy Extension Definition Linkbase Document, (v) XBRL Taxonomy Extension Label Linkbase Document, (vi) XBRL Taxonomy Extension Presentation Linkbase Document.

32 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures