What changed in this filing

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Item 9A. Controls and Procedures

2022-02-28 compared with 2021-03-25 · 64 added, 24 removed, 120 unchanged (42% of the section changed)

4 unchanged sentences

Management’s Annual Report on Internal Control over Financial Reporting

This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal control over financial reporting or an attestation report of the Company’s registered public accounting firm due to a transition period established by rules of the SEC for newly public companies.

Management of the Company is responsible for establishing and maintaining adequate internal control over the Company’s financial reporting, as defined in Rule 13a-15(f) of the Exchange Act.

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.

As of December 31, 2021, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013).

Based on this assessment, management, under the supervision and with the participation of our principal executive officer and principal financial officer, concluded that, as of December 31, 2021, our internal control over financial reporting was effective.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the shareholders and the Board of Directors of Harmony Biosciences Holdings, Inc.

Opinion on Internal Control over Financial Reporting

We have audited the internal control over financial reporting of Harmony Biosciences, Inc.

and subsidiary (the “Company”) as of December 31, 2021, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, 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, 2021, of the Company and our report dated February 28, 2022, expressed an unqualified opinion on those financial statements and included an explanatory paragraph regarding the Company’s adoption of a new accounting standard.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

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.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion .

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed 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.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Deloitte & Touche LLP

Chicago, Illinois

February 28, 2022

Changes in Internal Control over Financial Reporting

6 unchanged sentences

Other Information.

Disclosures Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

Directors, Executive Officers and Corporate Governance.

25 unchanged sentences

EXHIBIT INDEX

Exhibit Description

Incorporated by Reference

Exhibit Description

Amended and Restated Certificate of Incorporation of Harmony Biosciences Holdings, Inc.

5 unchanged sentences

Description of Registrant’s Securities.

Credit Agreement, dated as of January 9, 2020, among Harmony Biosciences, LLC, the Lenders from time to time party thereto and OrbiMed Royalty & Credit Opportunities III, LP.

July 27, 2020

Pledge and Security Agreement, dated as of January 9, 2020, among Harmony Biosciences, LLC, the Registrant, OrbiMed Royalty & Credit Opportunities III, LP and the Secured Parties as defined therein.

July 27, 2020

March 25, 2021

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.

August 10, 2021

Pledge and Security Agreement, dated as of August 9, 2021, among Harmony Biosciences, Inc.

and Harmony Biosciences, LLC, as Grantors, the Grantors from time to time party thereto, and Wilmington Trust, National Association, as Administrative Agent.

August 10, 2021

Harmony Biosciences Holdings, Inc.

10 unchanged sentences

August 11, 2020

Amended and Restated Employment Agreement, dated August 11, 2020, by and between Harmony Biosciences, LLC and

Amended and Restated Employment Agreement, dated August 11, 2020, by and between Harmony Biosciences, LLC and John C.

August 11, 2020

26 unchanged sentences

July 27, 2020

Offer Letter, dated September 7, 2017, by and between Harmony

Biosciences, LLC and Jeffrey Dierks .

Offer Letter, dated September 7, 2017, by and between Harmony Biosciences, LLC and Jeffrey Dierks.

March 25, 2021

Confidential Separation Agreement and General Release, between Harmony Biosciences, LLC and Susan L.

Drexler, dated March 4, 2021.

March 10, 2021

Employment Agreement, dated March 4, 2021, between Harmony Biosciences, LLC and Sandip Kapadia.

March 15, 2021

Promotion Increase Award Letter to Jeffrey Dierks, dated June 9, 2021 .

August 10, 2021

List of Subsidiaries of Harmony Biosciences Holdings, Inc.

11 unchanged sentences

This certification is deemed furnished, and not filed, with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Harmony Biosciences Holdings, Inc.

Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.

Certain portions of this document that constitute confidential information have been redacted in accordance with Regulation S-K, Item 601(b)(10)

3 unchanged sentences

President, Chief Executive Officer and Director

March 25, 2021

February 28, 2022

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

President, Chief Executive Officer, and Director (Principal Executive Officer)

March 25, 2021

Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)

March 25, 2021

President, Chief Executive Officer, and Director

February 28, 2022

(Principal Executive Officer)

/s/ Sandip Kapadia

Chief Financial Officer (Principal

February 28, 2022

Sandip Kapadia

Financial Officer and Principal Accounting Officer)

/s/ Jeffrey S.

Chairman of the Board

March 25, 2021

February 28, 2022

/s/ Antonio Gracias

March 25, 2021

February 28, 2022

Antonio Gracias

March 25, 2021

/s/ Eric Motley

March 25, 2021

February 28, 2022

/s/ Jack Bech Nielsen

March 25, 2021

February 28, 2022

Jack Bech Nielsen

March 25, 2021

February 28, 2022

/s/ Gary Sender

March 25, 2021

February 28, 2022

/s/ Linda Szyper

February 28, 2022

/s/ Andreas Wicki

March 25, 2021

February 28, 2022

Andreas Wicki

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