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 April 15, 2025

Sandip Kapadia
Chief Financial Officer
Harmony Biosciences Holdings, Inc.
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462

 Re: Harmony Biosciences Holdings, Inc.
 Form10-K for Fiscal Year Ended December 31 , 2024
 File No. 001-39450
Dear Sandip Kapadia:

 We have completed our review of your filings. We remind you that the
company and
its management are responsible for the accuracy and adequacy of their
disclosures,
notwithstanding any review, comments, action or absence of action by the staff.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
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</DOCUMENT>

CORRESP
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 April 9, 2025 ​ Eric Atallah United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 ​ RE: Harmony Biosciences Holdings, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed February 25, 2025 Form 8-K dated February 25, 2025 File No. 001-39450 ​ Dear Mr. Atallah: ​ Set forth below is the response of Harmony Biosciences Holdings, Inc. (the “Company”) to a comment received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “SEC”) by letter, dated March 28, 2025 regarding the Company’s filings referenced above.  The Company’s response is provided underneath your original comments below. ​ SEC Comment ​ Form 8-K Dated February 25, 2025 ​ Exhibit 99.1 ​ 1. We note that your non-GAAP adjusted net income includes adjustments for upfront licensing fees, milestone payments and IPR&D charges incurred in connection with asset acquisitions. Please tell us how you determined that these adjustments do not represent normal, recurring, cash operating expenses necessary to operate your business. Refer to Question 100.01 of the Compliance & Disclosure Interpretations on Non-GAAP Financial Measures. ​ Company Response ​ We respectfully acknowledge the Staff’s comment and advise the Staff that we will not include adjustments for upfront licensing fees, milestone payments and IPR&D charges incurred in connection with asset acquisitions in any future presentations of our non-GAAP measures. ​ ​ ​ Harmony Biosciences Holdings, Inc. is committed to fully complying with the SEC’s disclosure requirements. Please do not hesitate to contact me at (484) 539-9750 if you have any questions or require further information. ​ Sincerely, ​ /s/ Sandip Kapadia Sandip Kapadia Chief Financial Officer ​

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 March 28, 2025

Sandip Kapadia
Chief Financial Officer
Harmony Biosciences Holdings, Inc.
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462

 Re: Harmony Biosciences Holdings, Inc.
 Form10-K for Fiscal Year Ended December 31 , 2024
 Form 8-K Dated February 25, 2025
Dear Sandip Kapadia:

 We have limited our review of your filing to the financial statements
and related
disclosures and have the following comment.

 Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Form 8-K Dated February 25, 2025
Exhibit 99.1

1. We note your non-GAAP adjusted net income includes adjustments for
upfront
 licensing fees, milestone payments and IPR&D charges incurred in
connection with
 asset acquisitions. Please tell us how you determined that these
adjustments do not
 represent normal, recurring, cash operating expenses necessary to
operate your
 business. Refer to Question 100.01 of the Compliance & Disclosure
Interpretations on
 Non-GAAP Financial Measures.

 In closing, we remind you that the company and its management are
responsible for
the accuracy and adequacy of their disclosures, notwithstanding any review,
comments,
action or absence of action by the staff.
 March 28, 2025
Page 2

 Please contact Eric Atallah at 202-551-3663 or Gary Newberry at
202-551-3761 with
any questions.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
</TEXT>
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CORRESP
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    September 14, 2023

    Mr. David Plattner

    U.S. Securities and Exchange Commission

    Division of Corporation Finance

    Office of Mergers & Acquisitions

    100 F Street, N.E.

    Washington, D.C. 20549

          Re:

            Zynerba Pharmaceuticals, Inc.

    SC TO-T filed August 28, 2023

    Filed by Harmony Biosciences Holdings, Inc.

    File No. 005-88971

    Mr. Plattner:

    This letter responds to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in the Staff’s letter dated September 7, 2023 (the “Staff Letter”) regarding the Schedule TO-T (the “Schedule TO”) filed by Harmony Biosciences Holdings, Inc., a Delaware corporation (“Harmony”) and Xylophone Acquisition Corp., a Delaware corporation and wholly owned
      subsidiary of Harmony (the “Purchaser” and together with Harmony, the “Filing Persons”), on August 28, 2023 (File No. 005-88971).
      The Filing Persons hereby set forth below responses to the comments of the Staff contained in the Staff Letter.

    The numbering of the paragraphs below corresponds to the numbering of the comments in the Staff Letter. For the Staff’s convenience, the Filing Persons have incorporated the Staff’s comments into this response letter (in bold italics). Capitalized terms used in this letter but otherwise not defined herein shall have the meanings ascribed to such terms in the Schedule TO and the Offer to Purchase filed as
      Exhibit (a)(1)(A) thereto (as amended, the “Offer to Purchase”).

    Schedule TO-T filed August 28, 2023

    General

          1.

            In the Offer to Purchase, please disclose – as was done in the
                August 14 press release – the per Share value of the various potential CVR payments, as well as the aggregate figure.

    Response: Concurrently with our submission of this letter, the Filing Persons are filing an amendment to the Schedule TO, and exhibits thereto (the “TO
        Amendment”), setting forth, among other things, a more expanded disclosure of the per Share value of the various potential CVR Payments as well as the aggregate potential payments with respect to the CVRs.

            2.

              On pages 3 and 48, please clarify, if true, that Milestones 3
                  and 4, unlike the other Milestones, have no separate deadline by which achievement is necessary, other than the general termination date of December 31, 2040.

    Response: Concurrently with our submission of this letter, the Filing Persons are filing the TO Amendment clarifying, among other things, that Milestone 3 and Milestone 4 have no separate deadline by which
      achievement is necessary other than the general termination date of the CVR Agreement of December 31, 2040.

          3.

            We note the copy of the Merger Agreement incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K (File No.
              001-37526) filed on August 14, 2023. Such copy, though labeled as the “Execution Version” and including signatures on the signature page, includes the following disclaimer on the cover page: “NO AGREEMENT, ORAL OR WRITTEN, REGARDING OR
              RELATING TO ANY OF THE MATTERS COVERED BY THIS DOCUMENT HAS BEEN ENTERED INTO BETWEEN THE PARTIES. THIS DOCUMENT IS INTENDED SOLELY TO FACILIATE DISCUSSIONS AMONG THE PARTIES IDENTIFIED HEREIN. IT IS NOT INTENDED TO CREATE, AND WILL NOT BE
              DEEMED TO CREATE, A LEGALLY BINDING OR ENFORCEABLE OFFER OR AGREEMENT OF ANY TYPE OR NATURE BY THE COMPANY.” Please file a copy of the actual, executed Merger Agreement, or advise.

    Response: The Agreement and Plan of Merger (the “Merger Agreement”) was entered into by each of Harmony Biosciences Holdings, Inc., Xylophone
      Acquisition Corp. and Zynerba Pharmaceuticals, Inc. as of August 14, 2023. On such date, the Merger Agreement and the obligations of the parties thereunder became binding thereon. The cover page disclaimer was retained in the executed version of the
      Merger Agreement in error. The substance of the Merger Agreement is not impacted by this error and the Merger Agreement remains in full force and effect as filed. Concurrently with our submission of this letter, the Filing Persons are filing an
      amendment to the Current Report on Form 8-K filed on August 14, 2023 (File No. 001-39450) (the “Form 8-K/A”), which provides for a corrected Merger Agreement without the cover page
      disclaimer. Also concurrently with our submission of this letter, the Filing Persons are filing the TO Amendment providing, among other things, that the Merger Agreement filed in the Form 8-K/A is incorporated by reference to the Schedule TO-T
      instead of the prior version filed.

    Thank you for your review of the filing. Please contact me if you have any further comments or need additional information with respect to the filing.

    Sincerely,

            /s/ Peter Cohen-Millstein

            Hogan Lovells US LLP

          cc:
          William Intner, Hogan Lovells US LLP

United States securities and exchange commission logo
September 13, 2023
Sandip Kapadia
Chief Financial Officer
Harmony Biosciences Holdings, Inc.
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462
Re:Harmony Biosciences Holdings, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 21, 2023
File No. 001-39450
Dear Sandip Kapadia:
            We have completed our review of your filings.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
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Eric Atallah and Tara Harkins

United States Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

​

RE: Harmony Biosciences Holdings, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2022

Filed February 21, 2023

File No. 001-39450

​

Dear Mr. Atallah and Ms. Harkins:

​

On behalf of Harmony Biosciences Holdings, Inc. (the “Company”), this is written in response to your letter dated August 31, 2023 regarding the Company’s filing referenced above.  The Company’s response is provided underneath your original comments below.

​

SEC Comment

​

Form 10-K for the Fiscal Year Ended December 31, 2022

​

Item 7. Management’s Discussion and Analysis of Financial Condition and Result of Operations

​

Result of Operations, page 81.

​

 1.

 We note that you attribute the 43.4% increase in product revenue to "the growth in the average number of patients on WAKIX and price increases." Please revise future filings to specifically describe the extent to which these changes are attributable to changes in prices or to changes in sales volume. Refer to Item 303(b)(2)(iii) of Regulation S-K.

​

 2.

 As a related matter, where you describe two or more factors that contributed to a material change in a financial statement line item between periods, please quantify the extent to which each factor contributed to the overall change in that line item. Refer to Item 303(b)(2) of Regulation S-K and SEC Release No. 33-8350 for guidance.

​

Company Response

​

We respectfully acknowledge the Staff’s comments and advise the Staff that we will revise our disclosure in Part I, Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations under the caption “Results of Operations” in our future filings, beginning with the Form 10-Q for the quarter ended September 30, 2023.

​

​

Harmony Biosciences Holdings, Inc. is committed to fully complying with the SEC disclosure requirements.  After you have had the opportunity to review this letter, please call me at (484) 643-0005 to confirm that the responses in this letter satisfactorily address your comments or to raise any additional questions or comments you may have.

​

Sincerely,

​

/s/ Sandip Kapadia

Sandip Kapadia

Chief Financial Officer

United States securities and exchange commission logo
August 31, 2023
Sandip Kapadia
Chief Financial Officer
Harmony Biosciences Holdings, Inc.
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462
Re:Harmony Biosciences Holdings, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 21, 2023
File No. 001-39450
Dear Sandip Kapadia:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.  In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2022
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations , page 81
1.We note that you attribute the 43.4% increase in product revenue to "the growth in the
average number of patients on WAKIX and price increases."  Please revise future filings
to specifically describe the extent to which these changes are attributable to changes in
prices or to changes in sales volume.   Refer to Item 303(b)(2)(iii) of Regulation S-K.
2.As a related matter, where you describe two or more factors that contributed to a material
change in a financial statement line item between periods, please quantify the extent to
which each factor contributed to the overall change in that line item. Refer to Item
303(b)(2) of Regulation S-K and SEC Release No. 33-8350 for guidance.

 FirstName LastNameSandip Kapadia
 Comapany NameHarmony Biosciences Holdings, Inc.
 August 31, 2023 Page 2
 FirstName LastName
Sandip Kapadia
Harmony Biosciences Holdings, Inc.
August 31, 2023
Page 2
            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
            You may contact Eric Atallah at (202) 551-3663 or Tara Harkins, Reviewing Accountant,
at (202) 551-3639 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
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CORRESP

 August 14, 2020

VIA EDGAR

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 100 F Street, N.E.

Washington, D.C. 20549

Attn:
 Ms. Julia Griffith

Ms. Susan Block

Mr. Tracey McKoy

Mr. Kevin Vaughn

Re:
 Harmony Biosciences Holdings, Inc.

Registration Statement on Form S-1

Registration No. 333-240122

Acceleration Request

Requested Date: August 18, 2020

Requested Time: 4:30 PM, Eastern Daylight Time

Ladies and Gentlemen:

 In accordance with Rule
461 under the Securities Act of 1933, as amended (the “Act”), Goldman Sachs & Co. LLC, Jefferies LLC and Piper Sandler & Co., as representatives of the several underwriters, hereby join Harmony Biosciences
Holdings, Inc. in requesting that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-240122) (the “Registration Statement”) to become effective on August 18, 2020, at 4:30 PM, Eastern Daylight Time, or as soon as practicable thereafter.

Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary
prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement.

 We
have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.

[Signature Page Follows]

 Very truly yours,

 Goldman Sachs & Co. LLC

By:

 /s/ Goldman Sachs & Co. LLC

Name:

 Marc Schaffer

 Title:

 Managing Director

 Jefferies LLC

By:

/s/ Kevin Sheridan

Name:

 Kevin Sheridan

 Title:

 Joint Global Head, Investment Banking

 Piper Sandler & Co.

By:

/s/ Neil Riley

Name:

 Neil Riley

 Title:

 Managing Director

cc:
 John Jacobs, Harmony Biosciences Holdings, Inc.

Susan Drexler, Harmony Biosciences Holdings, Inc.

Stephanie Wisdo, Harmony Biosciences Holdings, Inc.

Christopher Lueking, Latham & Watkins LLP

Robert Puopolo, Goodwin Procter LLP

Seo Salimi, Goodwin Procter LLP

 [Signature Page to
Acceleration Request]

CORRESP
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CORRESP

 August 14, 2020

VIA EDGAR TRANSMISSION

 U.S. Securities and
Exchange Commission

 Division of Corporation Finance

 100 F
Street, N.E.

 Washington, DC 20549-6010

Attention:

Ms. Julia Griffith

Ms. Susan Block

Mr. Tracey McKoy

Mr. Kevin Vaughn

          Re:

Harmony Biosciences Holdings, Inc.

Registration Statement on Form S-1

Filed July 27, 2020

Registration No. 333-240122

 Dear Ms. Griffith:

In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby
request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on August 18, 2020, at 4:30 p.m., Eastern Daylight Time, or as soon thereafter as practicable, or at such later time
as Harmony Biosciences Holdings, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Christopher Lueking of Latham & Watkins LLP, counsel to the Company, at (312) 876-7680 to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.

 Sincerely yours,

 Harmony Biosciences Holdings, Inc.

By:

/s/ John C. Jacobs

 John C. Jacobs

 President and Chief Executive Officer

cc:
 Christopher Lueking, Esq.

CORRESP
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CORRESP

 July 31, 2020

 VIA EDGAR AND HAND
DELIVERY

 CONFIDENTIAL

 Securities and Exchange Commission

 Division of Corporation
Finance

 Office of Life Sciences

 100 F Street, N.E.

Washington, D.C. 20549

 Attention: Ms. Julia Griffith, Ms. Susan Block,

Ms. Tracey McKoy and Mr. Kevin Vaughn

 FOIA Confidential Treatment Request

Under 17 C.F.R. §200.83

Re:
 Harmony Biosciences Holdings, Inc.

 Anticipated Price Range in Registration Statement on Form S-1

 File No. 333-240122

 CIK No. 0001802665

Ladies and Gentlemen:

 On behalf of Harmony Biosciences Holdings,
Inc. (the “Company”), we submit this letter to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The
Company originally submitted the above-referenced Registration Statement (the “Registration Statement”) to the Commission on July 27, 2020. Because of the commercially sensitive nature of the information contained
herein, this submission is accompanied by the Company’s request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. A redacted
letter has been filed on EDGAR, omitting the confidential information contained in this letter.

 For the convenience of the Staff, we are providing
to the Staff copies of this letter by hand delivery and facsimile.

 July 31, 2020

 Page 2

 ESTIMATED IPO PRICE RANGE

To assist the Staff in its review, the Company advises the Staff that, although not yet reflected in the Registration Statement, based on discussions
with the Company’s board of directors and reflecting input from the lead underwriters (the “Underwriters”) for the Company’s initial public offering (“IPO”), if the Company were to commence
marketing of the transaction today, the Company presently anticipates that the estimated price range would be approximately $[***] to $[***] per share for the Company’s common stock (the “Preliminary IPO Price Range”)
with a midpoint of the anticipated range of approximately $[***] per share (the “Preliminary Assumed IPO Price”). The Preliminary IPO Price Range and Preliminary Assumed IPO Price do not reflect the anticipated [***] reverse
stock split that the Company intends to effect prior to the Commission’s declaration of effectiveness of the Registration Statement. The Company advises the Staff that the final range to be included in a
pre-effective amendment to the Registration Statement, after giving effect to an appropriate reverse stock split, will include a price range of no more than $2.00, if the maximum price is $10.00 per share or
less, or 20%, if the maximum price is greater than $10.00 per share, unless otherwise approved by the Staff.

 The Company’s final post-split
Preliminary IPO Price Range remains under discussion between the Company and the Underwriters, and a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus in
connection with the Company’s road show.

 ANALYSIS OF STOCK OPTION AND STOCK APPRECIATION RIGHTS GRANTS IN PRECEDING 12 MONTHS

The following table summarizes by grant date the number of shares of common stock underlying stock options granted during the preceding 12 months, as
well as the associated per share exercise price and the estimated fair value per share of the Company’s common stock on the date of such option grant, and the estimated fair value of options per share used to determine stock-based compensation
expense for financial reporting purposes.

 Grant Date

Number of
Shares
Underlying
Stock Options
Granted

Per Share
Exercise
Price of
Options

Estimated Fair
Value of
Common Stock
Per Share on
Grant Date

Per Share
Estimated
Fair Value
of Option

 August 5, 2019

70,000

$
1.00

$
0.65

$
0.50

 August 26, 2019

5,000

$
1.00

$
0.81

$
0.62

 September 30, 2019

30,000

$
1.00

$
0.81

$
0.62

 October 21, 2019

30,000

$
1.00

$
0.81

$
0.62

 October 28, 2019

300,000

$
1.00

$
0.81

$
0.62

 January 1, 2020

125,000

$
1.00

$
0.87

$
0.69

 January 13, 2020

5,000

$
1.00

$
0.87

$
0.69

 January 22, 2020

20,000

$
1.00

$
0.87

$
0.69

 February 26, 2020

30,000

$
1.00

$
0.87

$
0.69

 March 1, 2020

25,000

$
1.00

$
0.87

$
0.69

 March 2, 2020

20,000

$
1.00

$
0.87

$
0.69

 March 4, 2020

943,485

$
1.00

$
0.87

$
0.69

 March 16, 2020

85,000

$
1.00

$
0.87

$
0.69

 March 23, 2020

30,000

$
1.00

$
0.87

$
0.69

 May 7, 2020

100,000

$
1.67

$
1.67

$
1.30

 June 23, 2020

75,000

$
1.67

$
1.67

$
1.30

 CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED BY

 HARMONY BIOSCIENCES HOLDINGS, INC.

2

 July 31, 2020

 Page 3

 The following table summarizes by grant date
the number of shares of common stock underlying stock appreciation rights (“SARs”) granted during the preceding 12 months, as well as the associated per share base price and the estimated fair value per share of the
Company’s common stock on the grant date of each SAR, and the estimated fair value of SARs per share used to determine stock-based compensation expense for financial reporting purposes.

 Grant Date

Number of
Shares
Underlying
SARs Granted

Per Share
Base Price of
SARs

Estimated Fair
Value of
Common Stock
Per Share on
SARs Grant
Date

Per Share
Estimated Fair
Value of SARs

 June 23, 2020

75,000

$1.67

$1.67

$1.30

 The Company’s discussion of stock-based compensation for financial reporting purposes is primarily contained within
the section of the Registration Statement titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Stock-Based
Compensation,” which is included on pages 102 through 103 of the Registration Statement.

 As disclosed within the section of the Registration
Statement titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Common Stock Valuation,” the Company’s board
of directors has estimated the fair value of the Company’s common stock at various grant dates, with input from management, considering the Company’s most recently available third-party valuations of the common stock and the board of
directors’ assessment of additional objective and subjective factors that it believed were relevant, including:

 CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED BY

 HARMONY BIOSCIENCES HOLDINGS, INC.

3

 July 31, 2020

 Page 4

•

 the prices at which the Company sold shares of its redeemable convertible preferred stock in arm’s length transactions
and the superior rights, preferences and privileges of the convertible preferred stock relative to its common stock, including the liquidation preferences of its preferred stock;

•

 the Company’s short operating history;

•

 the Company’s actual operating results and financial performance;

•

 the progress of the Company’s commercialization of its approved product and research and development efforts for
additional indications;

•

 conditions in the industry and economy in general;

•

 the rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the
Company’s common stock;

•

 the likelihood of achieving a liquidity event for the holders of the Company’s common stock, such as an IPO or a sale
of the Company, given prevailing market conditions;

•

 equity market conditions affecting comparable public companies; and

•

 the lack of marketability of the Company’s common stock and the results of independent third party valuations.

 The Company’s board of directors also took into consideration the valuations of the Company’s common stock that were
prepared by an independent third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.
The assumptions underlying these valuations represented management’s best estimate, which involved inherent uncertainties and the application of management’s judgment. As a result, if the Company had used different assumptions or
estimates, the fair value of the Company’s common stock and the Company’s stock-based compensation expense could have been materially different.

Fair Value Determinations

August 5, 2019 Option Grants. The Company’s board of directors determined that the fair value of its
common stock was $0.65 per share as of August 5, 2019 based on input from management, the objective and subjective criteria discussed above and the results of its most recent third-party valuation performed as of February 13, 2019, which
was received by the Company on August 2, 2019. In reaching this determination, the board of directors determined that no material changes had occurred in the business since February 13, 2019.

 CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED BY

 HARMONY BIOSCIENCES HOLDINGS, INC.

4

 July 31, 2020

 Page 5

 As described in the Registration Statement
under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Common Stock Valuations,” the February 13,
2019 valuation analysis was performed using the income-based approach of a discounted cash flow method (“DCF”). DCF is based upon the theory that the value of a business is equal to the present value of its projected future
cash flows. The Company also applied a discount for lack of marketability to account for a lack of access to an active public market. The option pricing model was then used to determine the fair value of the Company’s common stock.

The February 13, 2019 valuation analysis resulted in a valuation of the Company’s common stock of $0.65 per share. Based on that result as
well as consideration of other qualitative factors, the Company’s board of directors determined that the fair value of the Company’s common stock was $0.65 per share as of August 5, 2019, when it granted stock options for the purchase
of 70,000 shares of common stock.

 August 26, 2019–October 28, 2019 Option
Grants.    The Company’s board of directors determined that the fair value of the Company’s common stock was $0.81 per share as of each of the grant dates from August 26, 2019 through October 28, 2019
based on input from management, the objective and subjective criteria discussed above and the results of its most recent third-party valuation performed as of August 14, 2019, which was received by the Company on October 25, 2019. In
reaching these determinations, the board of directors determined in each case that no material changes had occurred in the business since August 14, 2019.

As described in the Registration Statement under the heading “Management’s Discussion and Analysis of Financial Condition and Results of
Operations—Critical Accounting Policies and Significant Judgments and Estimates—Common Stock Valuations,” the August 14, 2019 valuation analysis was performed using an equally weighted combination of both DCF and the backsolve
method (“Backsolve”), a method for inferring the equity value implied by a recent financing transaction. The use of Backsolve in conducting the August 14, 2019 valuation was intended to leverage the August 9, 2019
financing transaction, which is described further below. The Company also applied a discount for lack of marketability to account for a lack of access to an active public market. The option pricing model was then used to determine the fair value of
the Company’s common stock.

 The approval by the U.S. Food and Drug Administration (“FDA”) on August 14, 2019 of
the Company’s first commercial product, WAKIX (pitolisant), for the treatment of excessive daytime sleepiness in adult patients with narcolepsy was a primary driver of the increase in the

 CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED BY

 HARMONY BIOSCIENCES HOLDINGS, INC.

5

 July 31, 2020

 Page 6

 Company’s common stock valuation from $0.65 as of
February 13, 2019 to $0.81 as of August 14, 2019. Another contributing factor was the Company’s issuance and sale on August 9, 2019 of 25,510,205 shares of its Series C convertible preferred stock at a purchase price of $1.96 per
share for aggregate consideration of approximately $50.0 million.

 The August 14, 2019 valuation analysis resulted in a valuation of the
Company’s common stock of $0.81 per share. Based on that result as well as consideration of other qualitative factors, the Company’s board of directors determined that the fair value of the Company’s common stock was $0.81 per share
as of each of the grant dates from August 26, 2019 through October 28, 2019, during which it granted stock options for the purchase of an aggregate of 365,000 shares of common stock.

January 1, 2020–March 23, 2020 Option Grants.    The Company’s board of
directors determined that the fair value of the Company’s common stock was $0.87 per share as of each of the grant dates from January 1, 2020 through March 23, 2020 based on input from management, the objective and subjective criteria
discussed above and the results of its most recent third-party valuation performed as of December 31, 2019, which was received by the Company on January 28, 2020. In reaching these determinations, the board of directors determined in each
case that no material changes had occurred in the business since December 31, 2019.

 As described above and in the Registration Statement under
the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Common Stock Valuations,” the December 31, 2019
valuation analysis was performed using a combination of both Backsolve and DCF.

 In conducting the December 31, 2019 valuation, Backsolve
constituted 25% of the valuation methodology while DCF constituted 75% of the valuation methodology. The reduced relative weight of Backsolve compared to DCF since the August 14, 2019 valuation was attributable to the results of the commercial
launch of WAKIX in November 2019, the increased ability of the Company to forecast potential future liquidity events and the amount of time that had lapsed since the last financing transaction. The Company also applied a discount for lack of
marketability to account for a lack of access to an active public market. As with prior valuations, the option pricing model was then used to determine the fair value of the Company’s common stock.

The December 31, 2019 valuation analysis resulted in a valuation of the Company’s common stock of $0.87 per share. Based on that result as
well as consideration of other qualitative factors, the Company’s board of directors determined that the fair value of the Company’s common stock was $0.87 per share as of each of the grant dates from January 1, 2020 through
March 23, 2020, when it granted stock options for the purchase of an aggregate of 1,283,485 shares of common stock.

 CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED BY

 HARMONY BIOSCIENCES HOLDINGS, INC.

6

 July 31, 2020

 Page 7

 May 7,
2020–June 23, 2020 Option and SARs Grants.    The Company’s board of directors determined that the fair value of the Company’s common stock was $1.67 per share as of each of the grant dates from May 7,
2020 through June 23, 2020 based on input from management, the objective and subjective criteria discussed above and the results of its most recent third-party valuation performed as of March 31, 2020, which was received by the Company on
May 5, 2020. In reaching these determinations, the board of directors determined in each case that no material changes had occurred in the business since March 31, 2020.

As the Company intends to describe in a subsequent amendment to the Registration Stateme

March 12, 2020
John C. Jacobs
Chief Executive Officer
Harmony Biosciences Holdings, Inc.
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462
Re:Harmony Biosciences Holdings, Inc.
Draft Registration Statement on Form S-1
Submitted February 14, 2020
CIK No. 0001802665
Dear Mr. Jacobs:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Overview, page 1
1.Briefly expand the disclosure regarding the six approved medications for the treatment of
narcolepsy by including the reasons these medications are prescribed, to balance the
negative side effects currently discussed.
2.Please expand your discussion of the company's strategy of expanding the label for
WAKIX to include cataplexy and pediatric applications to explain how each of these new
goals relate to the current offer.  If you will not be able to complete the related trials and
address the related development costs with the proceeds of the offer, please disclose that
these goals will not be achievable without additional funding.

 FirstName LastNameJohn C.  Jacobs
 Comapany NameHarmony Biosciences Holdings, Inc.
 March 12, 2020 Page 2
 FirstName LastNameJohn C.  Jacobs
Harmony Biosciences Holdings, Inc.
March 12, 2020
Page 2
Overview of the Development Pipeline, page 4
3.We note the inclusion of four proposed label expansions in the table on page 4.  Please
expand the table and your disclosure  to provide more information about the company's
progress with respect to pre-clinical trials for these label expansions.  If you have
undertaken IND enabling studies for any of the treatments listed in the table, please
describe these studies in the disclosure.  Alternatively, please state in the disclosure
surrounding the table where you are in the IND process.
4.Please balance the pipeline table disclosure by stating the approximate number of patients
worldwide who could benefit from each of the therapies in the table or otherwise clarify
your estimate of the potential market size for each therapy.
Risk Factors, page 14
5.We note that there are references to foreign regulators and foreign markets throughout the
Risk Factors and other sections of your prospectus.  Please revise to explain what non-US
markets, if any, you plan to enter, and what steps you have taken to attain the necessary
regulatory and patent approvals.
6.We note your disclosure on page 168 that your exclusive forum provision does not apply
to actions arising under the Securities Act or the Exchange Act. Please ensure that the
exclusive forum provision in the bylaws (as effective on the closing of the offering) states
this clearly, or tell us how you will inform investors in future filings that the provision
does not apply to any actions arising under the Securities Act or Exchange Act.
Use of Proceeds, page 72
7.We note the use of proceeds to fund the clinical development of additional indications for
pitolisant in PWS, DM1 and pediatric narpcolepsy.  Please revise to specify how far the
proceeds of the offering will take the company into the clinical development of these
potential additional indications.  If any material amounts of other funds are necessary to
accomplish the specified purposes for which the proceeds are to be obtained, state the
amounts and sources of such other funds needed for each such specified purpose and the
sources thereof.  Refer to Instruction 3 of Item 504 of Regulation S-K.

Management's Discussion and Analysis of Financial Condition and Results of Operations
Cost of Product Sales, page 81
8.Please revise to address the following:
•Disclose the amount of estimated historical cost of the inventory build-up prior to
your regulatory approval that had been expensed as research and development
expenses for each period presented.
•Disclose the effect zero cost inventory had on your historical results of operations.
•Disclose the expected effect on future results of operations and the assumptions made

 FirstName LastNameJohn C.  Jacobs
 Comapany NameHarmony Biosciences Holdings, Inc.
 March 12, 2020 Page 3
 FirstName LastNameJohn C.  Jacobs
Harmony Biosciences Holdings, Inc.
March 12, 2020
Page 3
in this regards.
•Disclose what the shelf life of your inventory is and your consideration of whether or
not any additional inventory will be determined to be obsolete in future periods.
•Disclose what you estimate your gross margin percentage will be after the zero cost
inventories are sold.
Liquidity and Capital Resources, page 86
9.You disclose that the Credit Agreement with OrbiMed requires compliance with certain
financial covenants, including minimum net revenue thresholds and cash balance
requirements, and financial reporting requirements.   Please amend your filing to disclose
whether you were in compliance with your covenants for each period presented.  If not,
please discuss any consequences that you may be subject to as a result of default, absent a
waiver.
Stock-Based Compensation, page 93
10.Please revise to disclose the extent to which any stock-based compensation has been
awarded during 2019 and through the date of your filing, and provide the fair valuations
of each award in the Common Stock Valuations section that follows on page 94. Once you
have an estimated offering price or range, please explain to us how you determined the
fair value of the common stock underlying your equity issuances and the reasons for any
differences between the recent valuations of your common stock leading up to the initial
public offering and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Competition, page 122
11.Expand your discussion of competition to discuss the principal methods of competition,
including price.  Identify the positive and negative factors affecting Harmony's
competitive position, to the extent they are known.  Refer to Regulation S-K, Item
101(b)(2)(x).
General
12.Please provide us mockups of any pages that include any additional pictures or graphics to
be presented, including any accompanying captions. Please keep in mind, in scheduling
your printing and distribution of the preliminary prospectus, that we may have comments
after our review of these materials.
13.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.

 FirstName LastNameJohn C.  Jacobs
 Comapany NameHarmony Biosciences Holdings, Inc.
 March 12, 2020 Page 4
 FirstName LastName
John C.  Jacobs
Harmony Biosciences Holdings, Inc.
March 12, 2020
Page 4
            You may contact Tracey McKoy at 202-551-3772 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Julia Griffith at 202-551-3267 or Susan Block at 202-551-3210 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences