SecProbe.io

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