2 unchanged sentences
Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
−Removed: A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
+Added: A control system, no matter how well designed and operated, can provide only
+Added: reasonable, not absolute, assurance that the objectives of the control system are met.
Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
6 unchanged sentences
Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States of America.
−Removed: The Company acquired Zynerba on October 10, 2023.
−Removed: SEC guidance permits companies to exclude certain acquisitions from the assessment of internal control over financial reporting during the first year following acquisition.
−Removed: Accordingly, management has excluded Zynerba from its assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2023.
−Removed: Zynerba represents approximately 8% and 0% of total assets and net product revenue, respectively, of the consolidated financial statement amounts as of and for the year ended December 31, 2023.
Our independent registered public accounting firm, Deloitte & Touche LLP, has issued an attestation report on our internal control over financial reporting that is included in this Annual Report on Form 10-K.
6 unchanged sentences
We have audited the internal control over financial reporting of Harmony Biosciences Holdings, Inc., and subsidiaries (the “Company”) 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 (COSO).
−Removed: In our opinion, the Company
−Removed: maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
+Added: 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 COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2024, of the Company and our report dated February 25, 2025, expressed an unqualified opinion.
−Removed: As described in Management’s Annual Report on Internal Control over Financial Reporting, management excluded from its assessment the internal control over financial reporting at Zynerba Pharmaceuticals, Inc., which was acquired on October 10, 2023, and whose financial statements constitute 8% of total assets and 0% of net product revenue of the consolidated financial statement amounts as of and for the year ended December 31, 2023.
−Removed: Accordingly, our audit did not include the internal control over financial reporting at Zynerba Pharmaceuticals, Inc.
Basis for Opinion
1 unchanged sentence
Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
+Added: We are a public accounting firm registered with the PCAOB and
+Added: are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
25 unchanged sentences
We will post any amendments to our code of business conduct and ethics other than technical, administrative or other non-substantive amendments, or waivers of its requirements, on our website or in a Form 8-K filed with the SEC.
+Added: We have adopted an Insider Trading Policy that governs the purchase, sale, and/or other dispositions of our securities by directors, officers and employees that is reasonably designed to promote compliance with insider trading laws, rules and regulations, and the listing requirements of NASDAQ.
+Added: A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
Executive Compensation.
32 unchanged sentences
March 25, 2021
−Removed: Credit Agreement, dated as of August 9, 2021, among Harmony Biosciences, Inc., as Borrower, Harmony Biosciences, LLC, as Guarantor, the Guarantors from time to time party thereto, the Lenders from time to time party thereto, and Wilmington Trust, National Association, as Administrative Agent.
−Removed: August 10, 2021
−Removed: Pledge and Security Agreement, dated as of August 9, 2021, among Harmony Biosciences, Inc.
−Removed: and Harmony Biosciences, LLC, as Grantors, the Grantors from time to time party thereto, and Wilmington Trust, National Association, as Administrative Agent.
−Removed: August 10, 2021
Harmony Biosciences Holdings, Inc.
10 unchanged sentences
August 11, 2020
−Removed: Amended and Restated Employment Agreement, dated August 11, 2020, by and between Harmony Biosciences, LLC and John C.
+Added: Amended and Restated Employment Agreement, dated August 11, 2020, by and
August 11, 2020
+Added: between Harmony Biosciences, LLC and John C.
Acknowledgment and Release Agreement, dated January 20, 2023, by and between Harmony Biosciences Holdings, Inc.
26 unchanged sentences
July 27, 2020
−Removed: Management Services Agreement, dated September 22, 2017, by and between Paragon Biosciences, LLC and Harmony Biosciences, LLC.
−Removed: July 27, 2020
Right of Use Agreement, dated November 1, 2019, by and between Paragon Biosciences, LLC and Harmony Biosciences, LLC.
20 unchanged sentences
July 27, 2023
−Removed: First Incremental Amendment dated September 21, 2023 by and among Harmony Biosciences Holdings, Inc., JPMorgan Chase Bank, N.A., as
+Added: First Incremental Amendment dated September 21, 2023 by and among Harmony Biosciences Holdings, Inc., JPMorgan Chase Bank, N.A., as administrative agent, and Bank of America, N.A., as incremental lender.
September 25, 2023
−Removed: administrative agent, and Bank of America, N.A., as incremental lender.
+Added: Insider Trading Policy
List of Subsidiaries of Harmony Biosciences Holdings, Inc.
1 unchanged sentence
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
+Added: Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended,
+Added: as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Executive Officer pursuant to 18 U.S.C.
36 unchanged sentences
February 25, 2025
−Removed: /s/ Jack Bech Nielsen
February 25, 2025
−Removed: Jack Bech Nielsen
−Removed: February 22, 2024
/s/ Gary Sender
6 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.