UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
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Non-accelerated filer | ☐ | Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of October 28, 2022, there were
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| September 30, |
| December 31, | |||
| 2022 |
| 2021 | |||
ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents | $ | | $ | | ||
Investments, short-term | | — | ||||
Trade receivables, net |
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Inventory, net |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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NONCURRENT ASSETS: |
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Property and equipment, net |
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Restricted cash |
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Investments, long-term | | — | ||||
Intangible assets, net |
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Deferred tax asset | | — | ||||
Other noncurrent assets |
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Total noncurrent assets |
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TOTAL ASSETS | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Trade payables | $ | | $ | | ||
Accrued compensation |
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Accrued expenses |
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Current portion of long-term debt | | | ||||
Other current liabilities |
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Total current liabilities |
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NONCURRENT LIABILITIES: |
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Long-term debt, net |
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Other noncurrent liabilities |
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Total noncurrent liabilities |
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TOTAL LIABILITIES |
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COMMITMENTS AND CONTINGENCIES (Note 12) |
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STOCKHOLDERS’ EQUITY: |
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Common stock—$ |
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Additional paid in capital |
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Accumulated other comprehensive income (loss) | ( | — | ||||
Accumulated deficit |
| ( |
| ( | ||
TOTAL STOCKHOLDERS’ EQUITY |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | | $ | | ||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(In thousands, except share and per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
$ | | $ | | $ | | $ | | |||||
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Gross profit |
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Operating expenses: |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Operating income |
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Loss on debt extinguishment |
| — |
| ( |
| — |
| ( | ||||
Other expense (income), net |
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| — |
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| ( | ||||
Interest expense, net |
| ( |
| ( |
| ( |
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Income (loss) before income taxes |
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| ( |
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Income tax benefit (expense) |
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| ( | ||||
Net income | $ | | $ | ( | $ | | $ | | ||||
Unrealized loss on investments |
| ( |
| — |
| ( |
| — | ||||
Comprehensive income | $ | | $ | ( | $ | | $ | | ||||
EARNINGS PER SHARE: |
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Basic | $ | | $ | ( | $ | | $ | | ||||
Diluted | $ | | $ | ( | $ | | $ | | ||||
Weighted average number of shares of common stock - basic |
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Weighted average number of shares of common stock - diluted |
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The accompanying notes are an integral part of the unaudited condensed consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands, except share and per share data)
Accumulated | |||||||||||||||||
Additional | other | Total | |||||||||||||||
Common Stock | paid-in | comprehensive | Accumulated | stockholders’ | |||||||||||||
| Shares |
| Amount |
| capital |
| income (loss) |
| deficit |
| equity | ||||||
Balance as of December 31, 2021 |
| | $ | | $ | | $ | — | $ | ( | $ | | |||||
Net income |
| — |
| — |
| — | — |
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Unrealized loss on investments | — | — | — | ( | — | ( | |||||||||||
Issuance of common stock | | — | | — | — | | |||||||||||
Exercise of options |
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| — |
| | — |
| — |
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Stock-based compensation |
| — |
| — |
| | — |
| — |
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Balance as of September 30, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
Accumulated | |||||||||||||||||
Additional | other | Total | |||||||||||||||
Common Stock | paid-in | comprehensive | Accumulated | stockholders’ | |||||||||||||
| Shares |
| Amount |
| capital |
| income (loss) |
| deficit |
| equity | ||||||
Balance as of June 30, 2022 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Net income |
| — |
| — |
| — | — |
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Unrealized loss on investments | — | — | — | ( | — | ( | |||||||||||
Issuance of common stock | | — | | — | — | | |||||||||||
Exercise of options |
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| — |
| | — |
| — |
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Stock-based compensation |
| — |
| — |
| | — |
| — |
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Balance as of September 30, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
Additional | Total | |||||||||||||
Common Stock | paid-in | Accumulated | stockholders’ | |||||||||||
| Shares |
| Amount |
| capital |
| deficit |
| equity | |||||
Balance as of December 31, 2020 |
| | $ | | $ | | $ | ( | $ | | ||||
Net income |
| — |
| — |
| — |
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Issuance of common stock | | — | | — | | |||||||||
Exercise of stock options |
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Stock-based compensation |
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Balance as of September 30, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Additional | Total | |||||||||||||
Common Stock | paid-in | Accumulated | stockholders’ | |||||||||||
| Shares |
| Amount |
| capital |
| deficit |
| equity | |||||
Balance as of June 30, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Net income |
| — |
| — |
| — |
| ( |
| ( | ||||
Issuance of common stock | | — | | — | | |||||||||
Exercise of options |
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| — |
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| — |
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Stock-based compensation |
| — |
| — |
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| — |
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Balance as of September 30, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands, except share and per share data)
| Nine Months Ended September 30, | ||||||
| 2022 |
| 2021 | ||||
CASH FLOWS FROM OPERATING ACTIVITIES |
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Net income | $ | | $ | | |||
Adjustments to reconcile net income to net cash used in operating activities: |
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Depreciation |
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Intangible amortization |
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Stock-based and employee stock purchase compensation expense |
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Stock appreciation rights market adjustment |
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Debt issuance costs amortization |
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Deferred taxes | ( | — | |||||
Investment securities interest income | ( | — | |||||
Loss on debt extinguishment | — | | |||||
Other non-cash expenses | | | |||||
Change in operating assets and liabilities: |
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Trade receivables |
| ( |
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Inventory |
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Prepaid expenses and other assets |
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Trade payables |
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Accrued expenses and other current liabilities |
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Other non-current liabilities |
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Net cash provided by operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of investment securities | ( | — | |||||
Proceeds from maturities and sales of investment securities | | — | |||||
Purchase of property and equipment |
| ( |
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Milestone payments |
| ( |
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Net cash used in investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock | | | |||||
Common stock issuance costs | — | ( | |||||
Proceeds from long term debt |
| — |
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Debt issuance costs |
| — |
| ( | |||
Extinguishment of debt |
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Extinguishment of debt exit fees |
| — |
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Principal repayment of long term debt | ( | — | |||||
Proceeds from exercised options |
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Net cash provided by financing activities |
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NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH |
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CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—Beginning of period |
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CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—End of period | $ | | $ | | |||
Supplemental Disclosure of Cash Flow Information: |
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Cash paid during the year for interest | $ | | $ | | |||
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share data)
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
The Company
Harmony Biosciences Holdings, Inc., and its consolidated subsidiary (the “Company”) was founded in July 2017 as Harmony Biosciences II, LLC, a Delaware limited liability company. The Company converted to a Delaware corporation named Harmony Biosciences II, Inc. in September 2017 and, in February 2020, the Company changed its name to Harmony Biosciences Holdings, Inc. The Company’s operations are conducted in its wholly owned subsidiary, Harmony Biosciences, LLC (“Harmony”), which was formed in May 2017. The Company is a commercial-stage pharmaceutical company focused on developing and commercializing innovative therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. The Company is headquartered in Plymouth Meeting, Pennsylvania.
Initial Public Offering
In August 2020, the Company completed its initial public offering (“IPO”) of common stock, in which it sold
2. LIQUIDITY AND CAPITAL RESOURCES
The unaudited condensed consolidated financial statements have been prepared as though the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulated deficit of $
The Company believes that its existing cash and cash equivalents on hand as of September 30, 2022, as well as additional cash generated from operating and financing activities will meet its operational liquidity needs and fund its planned investing activities for the next twelve months from the date of issuance of these unaudited condensed consolidated financial statements.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. All intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated balance sheet as of September 30, 2022, the unaudited condensed consolidated statements of cash flows for the nine months ended September 30, 2022, and 2021, and the unaudited condensed
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consolidated statements of operations and comprehensive income and the unaudited condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2022 and 2021, are unaudited. The balance sheet as of September 30, 2022, was derived from audited financial statements as of and for the year ended December 31, 2021. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements as of and for the year ended December 31, 2021, and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the nine months ended September 30, 2022 and 2021. The unaudited condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC’s rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
The Company has updated certain prior period disclosures within Note 11 in order to conform with current period presentation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosures in the unaudited condensed consolidated financial statements, including the notes thereto, and elsewhere in this report. Actual results may differ significantly from estimates, which include rebates due pursuant to commercial and government contracts, accrued research and development expenses, stock-based compensation expense and income taxes.
Uncertainties related to the magnitude and duration of COVID-19, the extent to which it will impact our future financial results, worldwide macroeconomic conditions including interest rates, employment rates, consumer spending and health insurance coverage, the speed of the anticipated recovery and governmental and business reactions to the pandemic have increased the complexity of developing estimates and assumptions used in the preparation of the unaudited condensed consolidated financial statements, including the carrying amounts of long-lived assets, and the intangible asset. Actual results may differ significantly from our estimates as a result of COVID-19.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents and restricted cash consist of cash and, if applicable, highly liquid investments with an original maturity of three months or less when purchased, including investments in Money Market Funds and debt securities that approximate fair value.
| As of | |||||
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Cash and cash equivalents | $ | | $ | | ||
Restricted cash |
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Total cash, cash equivalents, and restricted cash shown in the statements of cash flows | $ | | $ | | ||
Restricted cash includes amounts required to be held as a security deposit in the form of letters of credit for the Company’s credit card program and the fleet program.
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Investments
The Company’s investments consist of debt securities that are classified as available-for-sale. The short-term and long-term investments are carried at fair value and unrealized gains and losses are recorded as a component of accumulated comprehensive income in stockholders’ equity. The amortization of premiums and accretion of discounts adjust the carrying value of investments and are recorded in interest expense, net, on the unaudited condensed consolidated statements of operations and comprehensive income. Interest income and realized gains and losses, if any, are also recorded in interest expense, net, on the unaudited condensed consolidated statement of operations and comprehensive income. Realized gains and losses that result from the sale of investments are determined on a specific identification basis.
At each reporting period, the Company reviews any unrealized losses position to determine if the decline in the fair value of the underlying investments is a result of credit losses or other factors. If the assessment indicates that a credit loss exists, any impairment is recognized as an allowance for credit losses in our consolidated statement of operations.
Concentrations of Risk
Substantially all of the Company’s cash and money market funds are held in
The Company is also subject to credit risk from its trade receivables related to its product sales. The Company extends credit to specialty pharmaceutical distribution companies within the United States. Customer creditworthiness is monitored and collateral is not required. Historically, the Company has not experienced credit losses on its accounts receivable. The Company monitors its exposure within accounts receivable and would record a reserve against uncollectible accounts receivable if necessary As of September 30, 2022,
For the nine months ended September 30, 2022,
The Company depends on a single source supplier for each of its product and active pharmaceutical ingredient.
Recently Issued Accounting Pronouncements
ASU 2020-04, Reference Rate Reform (Topic 848). In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provides guidance related to reference rate reform. The pronouncement provides temporary optional expedients and exceptions to the current guidance on contract modifications and hedge accounting to ease the financial reporting burden related to the expected market
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transition from the London Interbank Offered Rate (“LIBOR”) and other interbank offered rates to alternative reference rates. The guidance was effective upon issuance and generally can be applied to applicable contract modifications through December 31, 2022. The Company is currently evaluating the impact of the transition from LIBOR to alternative reference rates but does not expect a significant impact to its condensed consolidated financial statements.
4. INVESTMENTS
The carrying value and amortized cost of the Company’s available-for-sale debt securities, summarized by type of security, consisted of the following:
September 30, 2022 | |||||||||
Amortized | Unrealized | Unrealized | Fair | ||||||
Cost | Gains | Losses | Value | ||||||
Short-term: | |||||||||
Commercial paper | $ | | | ( | $ | | |||
Corporate debt securities | | | ( | | |||||
U.S. government securities | | — | ( | | |||||
Total short-term investments | $ | | | ( | $ | | |||
Long-term: | |||||||||
Corporate debt securities | $ | | | ( | $ | | |||
U.S. government securities | | — | ( | | |||||
Total long-term investments | $ | | | ( | $ | | |||
The Company classifies investments with an original maturity of less than one year as current and investments with an original maturity date of greater than one year as noncurrent on its unaudited condensed consolidated balance sheet. The investments classified as noncurrent have maturity dates ranging from
5. FAIR VALUE MEASUREMENTS
The Company’s unaudited condensed consolidated financial statements include cash, cash equivalents, restricted cash, accounts payable, and accrued liabilities, all of which are short term in nature and, accordingly, approximate fair value.
It is the Company’s policy to measure non-financial assets and liabilities at fair value on a nonrecurring basis. These non-financial assets and liabilities are not measured at fair value on an ongoing basis but are subject to fair value adjustments in certain circumstances (such as evidence of impairment), which, if material, are disclosed in the accompanying footnotes.
The Company measures certain assets and liabilities at fair value based on the fair value hierarchy that prioritizes inputs to valuation techniques used to measure fair value into three levels based on the source of inputs as follows:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.
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Level 3—Valuations based on unobservable inputs and models that are supported by little or no market activity.
Money market funds are classified as Level 1 fair value instruments. Investments in available-for-sale debt securities are classified as Level 2 and carried at fair value, which we estimate utilizing a third-party pricing service. The pricing service utilizes industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. We validate valuations obtained from third-party services by obtaining market values from other pricing sources. The Company did not classify any assets or liabilities as Level 3 as of September 30, 2022 or December 31, 2021.
The Company’s assets measured at fair value consisted of the following:
September 30, 2022 | December 31, 2021 | ||||||||||||
Total | Level 1 | Level 2 | Total | Level 1 | Level 2 | ||||||||
Assets | |||||||||||||
Cash equivalents | $ | | | — | $ | | | — | |||||
Commercial paper | | — | | — | — | — | |||||||
Corporate debt securities | | — | | — | — | — | |||||||
U.S. government securities | | — | | — | — | — | |||||||
Total | $ | | | | $ | | | — | |||||
6. INVENTORY
Inventory, net consisted of the following:
| As of | |||||
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Raw materials | $ | | $ | | ||
Work in process |
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Finished goods |
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Inventory, gross |
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Reserve for excess inventory |
| ( |
| ( | ||
Total inventory, net | $ | | $ | | ||
7. INTANGIBLE ASSETS
In August 2019, the Company received FDA approval of WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (“EDS”) in adult patients with narcolepsy. This event triggered a milestone payment of $
In October 2020, the Company received FDA approval for the New Drug Application (“NDA”) for WAKIX for the treatment of cataplexy in adult patients with narcolepsy. This event triggered a milestone payment of $
In February 2022, the Company attained $
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Company capitalized as an intangible asset and paid in March of 2022. The Company determined a useful life of
Amortization expense was $
Future amortization expense relating to unamortized intangible assets as of September 30, 2022 for the periods indicated below consists of the following:
Years ending December 31, |
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2022 (Excluding the nine months ended September 30, 2022) | $ | | |
2023 |
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2024 |
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2025 |
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2026 |
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Thereafter | | ||
Total | $ | |
The gross carrying amount and net book value of the intangible assets is as follows:
| As of | |||||
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Gross Carrying Amount | $ | | $ | | ||
Accumulated Amortization |
| ( |
| ( | ||
Net Book Value | $ | | $ | | ||
8. LICENSE AND ASSET PURCHASE AGREEMENTS
In July 2017, Harmony entered into a License Agreement (“the 2017 LCA”) with Bioprojet Société Civile de Recherche (“Bioprojet”) whereby Harmony acquired the exclusive right to commercialize the pharmaceutical compound pitolisant for the treatment, and/or prevention, of narcolepsy, obstructive sleep apnea, idiopathic hypersomnia, and Parkinson’s disease as well as any other indications unanimously agreed by the parties in the United States and its territories. A milestone payment of $
On July 31, 2022, Harmony entered into a License and Commercialization Agreement (the “2022 LCA”) with Bioprojet whereby Harmony obtained exclusive rights to manufacture, use and commercialize one or more
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new products based on pitolisant in the United States and Latin America, with the potential to add additional indications and formulations upon agreement of both parties. Harmony will pay an initial, non-refundable $
Agreement Related to Intellectual Property
In August 2021, the Company entered into an asset purchase agreement with ConSynance Therapeutics, Inc. (the “APA”) to acquire HBS-102 (formerly referred to as “CSTI-100”), a potential first-in-class molecule with a novel mechanism of action. Under the terms of the APA, the Company acquired full development and commercialization rights globally, with the exception of Greater China, for $
9. ACCRUED EXPENSES
Accrued expenses consist of the following:
| As of | |||||
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Royalties due to third parties | $ | | $ | | ||
Rebates and other sales deductions |
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Interest | | | ||||
Selling and marketing |
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Research and development |
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Professional fees, consulting, and other services |
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Licensing fee | | — | ||||
Other expenses |
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$ | | $ | | |||
10. DEBT
Blackstone Credit Agreement
In August 2021, the Company entered into the Blackstone Credit Agreement that provides for (i) a senior secured term loan facility in an aggregate original principal amount of $
The repayment schedule for the Initial Term Loan consists of quarterly $
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payable quarterly, which commenced on November 9, 2021, and continues through the Maturity Date. The Initial Term Loan bears interest at a per annum rate equal to LIBOR, subject to a
Net cash received from the Initial Term Loan as a result of the transaction, less debt issuance costs of $
Long-term debt, net consists of the following:
| September 30, |
| December 31, | |||
2022 | 2021 | |||||
Liability component - principal | $ | | $ | | ||
Unamortized debt discount associated with debt financing costs |
| ( |
| ( | ||
Liability component - net carrying value | | | ||||
Less current portion | ( | ( | ||||
Long-term debt, net | $ | | $ | | ||
Future minimum payments relating to long-term debt, net as of September 30, 2022, for the periods indicated below consists of the following:
Years ending December 31, | |||
2022 (Excluding the nine months ended September 30, 2022) | $ | | |
2023 |
| | |
2024 |
| | |
2025 |
| | |
2026 |
| | |
Thereafter | — | ||
Total | $ | |
Interest expense related to the Company’s long-term debt, net, is included in interest expense, net in the unaudited condensed consolidated statements of operations and comprehensive income and consists of the following:
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2022 |
| 2021 | 2022 |
| 2021 | ||||||||
Interest on principal balance | $ | | $ | | $ | | $ | | |||||
Amortization of deferred financing costs |
| |
| |
| |
| | |||||
Total term loan interest expense | $ | | $ | | $ | | $ | | |||||
11. LEASES
In June 2018, the Company entered into an operating lease for approximately
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Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future lease payments using our incremental borrowing rate. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Our leases have remaining lease terms of less than
The Company recorded operating lease costs of $
As of September 30, 2022, the weighted-average remaining lease term for operating leases was
Supplemental balance sheet information related to operating leases was as follows:
Leases | Classification | September 30, 2022 | December 31, 2021 | |||
Assets | ||||||
Operating lease right-of-use assets | $ | | $ | | ||
Liabilities | ||||||
Operating lease liability, current portion | $ | | $ | | ||
Operating lease liability, long-term | | | ||||
Total operating lease liabilities | $ | | $ | |
Supplemental cash flow information related to operating leases was as follows:
September 30, 2022 | September 30, 2021 | ||||
Operating cash flows from operating leases | $ | | $ | | |
Right of use assets obtained in exchange for operating lease obligations (1) | $ | | $ | |
| (1) | Including the balance recognized on January 1, 2021, upon adoption of ASU No. 2016-02. |
Future payments under noncancelable operating leases with initial terms of one year or more as of September 30, 2022 consisted of the following:
Years ending December 31, |
| ||
2022 (Excluding the nine months ended September 30, 2022) | $ | | |
2023 |
| | |
2024 |
| | |
2025 |
| | |
2026 |
| — | |
Thereafter |
| — | |
Total lease payments | | ||
Less: imputed interest | ( | ||
Total lease liabilities | $ | |
12. COMMITMENTS AND CONTINGENCIES
Litigation
From time to time, the Company is subject to claims and suits arising in the ordinary course of business. The Company accrues such liabilities when they are known, if they are deemed probable and can be reasonably estimated. As of September 30, 2022, there were
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13. STOCKHOLDERS’ EQUITY
Common Stock
The holders of common stock are entitled to
14. STOCK INCENTIVE PLAN AND STOCK-BASED COMPENSATION
2020 Stock Incentive Plan
In connection with the Company’s IPO, the board of directors adopted, and its stockholders approved, the 2020 Incentive Award Plan (the “2020 Plan”), in order to facilitate the grant of cash and equity incentives to directors, employees (including the Company’s named executive officers) and consultants of the Company and its subsidiaries. The 2020 Plan provides for the grant of stock options, including incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”), SARs, restricted stock, dividend equivalents, restricted stock units (“RSUs”) and other stock or cash-based awards.
Stock options and stock appreciation rights under the 2020 Plan have a
2017 Stock Incentive Plan
On August 7, 2017, the Company adopted an equity incentive plan (the “2017 Plan”). Under the 2017 Plan, directors, officers, employees, consultants, and advisors of the Company can be paid incentive compensation measured by the value of the Company’s common shares through grants of stock options, stock appreciation rights (“SARs”), or restricted stock. Following the adoption of the 2020 Plan, no further grants have been, or will be, made under the 2017 Plan. However, the 2017 Plan will continue to govern the terms and conditions of outstanding awards granted under it.
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Stock Options
The following table summarizes stock option activity for the nine months ended September 30, 2022:
|
|
| Weighted- | ||||
Weighted- | Average | ||||||
Average | Remaining | ||||||
Number of | Exercise | Contractual | |||||
| Awards |
| Price |
| Term | ||
Awards outstanding—December 31, 2021 |
| | $ | |
| ||
Awards issued |
| | $ | |
|
| |
Awards exercised |
| ( | $ | |
|
| |
Awards forfeited |
| ( | $ | |
|
| |
Awards outstanding—September 30, 2022 |
| | $ | |
| ||
Stock Appreciation Rights
The following table summarizes SARs activity for the nine months ended September 30, 2022:
|
|
| Weighted- | ||||
Weighted- | Average | ||||||
Average | Remaining | ||||||
Number of | Exercise | Contractual | |||||
| Awards |
| Price |
| Term | ||
Awards outstanding—December 31, 2021 |
| | $ | |
| ||
Awards issued |
| — | $ | — |
|
| |
Awards exercised |
| ( | $ | |
|
| |
Awards forfeited |
| ( | $ | |
|
| |
Awards outstanding—September 30, 2022 |
| | $ | |
| ||
Restricted Stock Units
The following table summarizes RSU activity for the nine months ended September 30, 2022:
|
|
| Weighted- | ||||
Weighted- | Average | ||||||
Average | Remaining | ||||||
Number of | Exercise | Contractual | |||||
| Awards |
| Price |
| Term | ||
Awards outstanding—December 31, 2021 |
| | $ | |
| ||
Awards issued |
| — | $ | — |
|
| |
Awards exercised |
| — | $ | — |
|
| |
Awards forfeited |
| — | $ | — |
|
| |
Awards outstanding—September 30, 2022 |
| | $ | |
| ||
As of September 30, 2022 and December 31, 2021, stock awards issued under the 2017 and 2020 Plans of
Value of Stock Options and SARs
The Company values options and SARs using the Black-Scholes option-pricing model. The Company lacks sufficient historical company-specific volatility information. Therefore, the Company estimates expected stock volatility based on historical volatility of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-
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based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. For SARs, the expected term is based upon the weighting of certain future events. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for the time periods approximately equal to the expected term of the award. An expected dividend yield of
The assumptions used to value the awards are summarized in the following table.
As of | |||||
| September 30, |
| December 31, | ||
| 2022 |
| 2021 | ||
Dividend yield |
| | % | | % |
Expected volatility |
| % | | % | |
Risk-free interest rate |
| % | % | ||
Expected term (years) |
|
| |||
Value of RSUs
The fair value of RSUs is equal to the value of the Company’s common stock on the grant date.
The weighted average per share fair value of awards issued under the 2017 Plan and 2020 Plan was $
Stock-Based Compensation Expense
Stock-based compensation expense, net for the three and nine months ended September 30, 2022 and 2021, was recorded in the unaudited condensed consolidated statements of operations and comprehensive income in the following line items:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
Research and development expense | $ | | $ | | $ | | $ | | ||||
Sales and marketing expense |
| |
| |
| |
| | ||||
General and administrative expense |
| |
| |
| |
| | ||||
$ | | $ | | $ | | $ | | |||||
Stock-based compensation expense, net related to Options and RSUs issued under the 2017 Plan and 2020 Plan is included in stockholder’s equity, and a liability for SARs is included in other non-current liabilities, in the Company’s unaudited condensed consolidated balance sheet. As of September 30, 2022, the total unrecognized stock-based compensation expense related to Options and RSUs was $
Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan (“ESPP”) was adopted by the Company’s Board of Directors on April 30, 2021. The ESPP permits eligible employees to purchase shares of the Company’s common stock at a
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intended that the ESPP meet the requirements for an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. For both the three and nine months ended September 30, 2022, there were
15. EARNINGS PER SHARE
Basic earnings per share is calculated by dividing net income by the weighted average number of shares of common stock outstanding. Diluted net income per common share is computed under the treasury stock method by using the weighted average number of shares of common stock outstanding, plus, for periods with net income, the potential dilutive effects of stock options, stock appreciation rights, restricted stock units and warrants.
The following table sets forth the computation of basic and diluted net income per share:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2022 |
| 2021 |
| 2022 |
| 2021 | ||||||
Numerator |
|
|
|
|
|
|
| |||||
Net income | $ | | $ | ( | $ | | $ | | ||||
Denominator |
|
|
|
|
|
|
|
| ||||
Net income per common share - basic | $ | | $ | ( | $ | | $ | | ||||
Net income per common share - diluted | $ | | $ | ( | $ | | $ | | ||||
Weighted average number of shares of common stock - basic |
| |
| |
| |
| | ||||
Weighted average number of shares of common stock - diluted |
| |
| |
| |
| | ||||
Securities outstanding that are included in the computation above, utilizing the treasury stock method are as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2022 |
| 2021 |
| 2022 |
| 2021 | ||||||
Stock options, SARs, and RSUs to purchase common stock | | — | | | ||||||||
Warrants | — | — | — | | ||||||||
Total | | — | | | ||||||||
Potential common shares issuable that were excluded from the computation of diluted weighted-average shares outstanding excluded from the numerator, are as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2022 |
| 2021 |
| 2022 |
| 2021 | |||||||
Stock options, SARs, and RSUs to purchase common stock |
| |
| | |
| | ||||||
16. INCOME TAXES
As of September 30, 2022 and December 31, 2021, our deferred tax assets were primarily the result of acquired in-process research and development costs, operating loss carryforwards, deferred research and development costs, disallowed interest, inventory, and accrued rebates. A valuation allowance of $
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valuation allowance on certain deferred tax assets, net, which had accumulated through December 31, 2021. We also recorded a tax benefit of $
As of each reporting date, the Company considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. As of September 30, 2022, in part because in the current quarter we achieved three years of cumulative pretax income, which is a positive indication of the Company’s ability to generate sufficient future taxable income, the Company determined that there was sufficient positive evidence to conclude that it is more likely than not that additional deferred taxes are realizable and, therefore, released the valuation allowance accordingly.
17. RELATED-PARTY TRANSACTIONS
The Company was party to a management agreement for professional services provided by a related party, Paragon Biosciences, LLC (“Paragon”). The related party is an entity that shares common ownership with the Company. In addition, the Chairman of the Company’s board of directors was the President and owner of the entity. The Company terminated the management agreement upon the consummation of its IPO. The Company is also party to a right of use agreement with the related party whereby it has access to and the right to use certain office space leased by the related party in Chicago, Illinois. In addition, the Company had participated in certain transactions with separate related parties that also share common ownership with the Company, primarily related to combined employee health plans. The Company incurred $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, the anticipated impact of the COVID-19 pandemic on our business, business strategy, products, prospective products, product approvals, research and development costs, anticipated timing and likelihood of success of clinical trials, expected timing of the release of clinical trial data, the plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, statements about:
| ● | our commercialization efforts and strategy for WAKIX; |
| ● | the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; |
| ● | our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; |
| ● | our ongoing and planned clinical trials; |
| ● | our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); |
| ● | the availability of favorable insurance coverage and reimbursement for WAKIX; |
| ● | the impact of the COVID-19 pandemic; |
| ● | the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; |
| ● | our estimates regarding expenses, future revenue, capital requirements and additional financing needs; |
| ● | our ability to identify and/or acquire additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; |
| ● | our commercialization, marketing and manufacturing capabilities and strategy; |
| ● | significant competition in our industry; |
| ● | our intellectual property position; |
| ● | loss or retirement of key members of management; |
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| ● | failure to successfully execute our growth strategy, including any delays in our planned future growth; |
| ● | our failure to maintain effective internal controls; and |
| ● | the impact of government laws and regulations. |
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under the section in our most recent Annual Report on Form 10-K entitled “Item 1A. Risk Factors” and the sections in this Quarterly Report on Form 10-Q titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
Unless otherwise indicated, information contained in this Quarterly Report on Form 10-Q concerning our industry, including industry statistics and forecasts, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and other third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable. In addition, projections, forecasts, assumptions and estimates of the future performance of the industry in which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed and forecasts in the estimates made by the independent parties and by us.
You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
As used herein, the terms “Harmony,” “we,” “us,” “our” and “the Company” refer to Harmony Biosciences Holdings, Inc., a Delaware corporation and our operating subsidiary, Harmony Biosciences, LLC.
Company Overview
We are a commercial-stage, pharmaceutical company focused on developing and commercializing innovative therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. Our product, WAKIX (pitolisant), is a first-in-class molecule with a novel mechanism of action (“MOA”) specifically designed to increase histamine signaling in the brain by binding to H3 receptors. In August 2019, WAKIX was approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of excessive daytime sleepiness (“EDS”) in adult patients with narcolepsy, and its U.S. commercial launch was initiated in November 2019. In October 2020, WAKIX was
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approved by the FDA for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first-and-only approved product for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (the “DEA”).
Regarding pediatric narcolepsy and a pediatric indication for WAKIX, our partner, Bioprojet, has completed a Phase 3 trial in pediatric patients with narcolepsy. Bioprojet recently submitted the data to the European Medical Agency (“EMA”) seeking approval for a pediatric narcolepsy indication. The EMA’s decision on Bioprojet’s pediatric narcolepsy submission is expected in the first quarter of 2023 and could help inform our strategy toward submitting the data to the FDA. In the meantime, we are committed to obtaining pediatric exclusivity for WAKIX and submitted a request for a pediatric written request this quarter.
We believe that pitolisant’s ability to regulate histamine gives it the potential to provide therapeutic benefit in other rare neurological diseases that are mediated through H3 receptors and histamine signaling. We are taking a mechanism-based approach to managing the life cycle of pitolisant and have identified idiopathic hypersomnia (“IH”), another central disorder of hypersomnolence like narcolepsy, as our next potential new indication for WAKIX. In April, we initiated a Phase 3 registrational trial (the “INTUNE Study”) to evaluate the efficacy and safety of pitolisant in adult patients with IH and have seen good momentum in patient enrollment, with over 70% of the targeted clinical trial sites activated. We are focusing our development efforts on other rare neurological disorders in which EDS is a prominent symptom, including Prader-Willi Syndrome (“PWS”) and myotonic dystrophy, otherwise known as dystrophia myotonica (“DM”). We recently received the initial topline data from our Phase 2 proof-of-concept clinical trial to evaluate pitolisant for the treatment of EDS and other key symptoms in patients with PWS. The topline data showed a positive signal on the primary outcome related to EDS and we look forward to receiving the full data set, which will inform our understanding of the data as we plan to advance our development program in patients with PWS. In June 2021, we initiated a Phase 2 proof-of-concept clinical trial to evaluate pitolisant for the treatment of EDS, fatigue and cognitive dysfunction in adult patients with DM1 and anticipate topline results from this trial in 2023.
We also seek to expand our pipeline through the acquisition of additional assets that focus on addressing the unmet needs of patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. We are targeting assets that will allow us to further leverage the expertise and infrastructure that we have successfully built at Harmony so we can optimize the benefit of internal synergies. Consistent with this objective, on July 31, 2022, we entered into a License and Commercialization Agreement (the “2022 LCA”) with Bioprojet whereby we obtained exclusive rights to manufacture, use and commercialize one or more new products based on pitolisant in the United States and Latin America, with the potential to add additional indications and formulations upon agreement of both parties.
In addition, on August 4, 2021, we acquired HBS-102, a Melanin-concentrating hormone receptor 1 (MCHR1) antagonist previously developed as CSTI-100/ALB-127258(a)/ALB-127258 (the “Compound”), along with intellectual property and other assets related to the development, manufacture, and commercialization of the Compound from ConSynance Therapeutics, Inc. In connection with the acquisition, we made an upfront payment of $3.5 million and will be required to make certain payments upon the achievement of certain development milestones, regulatory milestones, and sales milestones and pay ongoing royalties upon commercialization. We acquired full development and commercialization rights globally, but we have provided a grant-back license to ConSynance for the development and commercialization of the Compound in Greater China. We have recently initiated a preclinical proof-of-concept study to assess the effect of HBS-102 on hyperphagia, weight gain, and other metabolic parameters in a mouse model of PWS.
Pitolisant was developed by Bioprojet and approved by the EMA in 2016 for the treatment of narcolepsy in adult patients with or without cataplexy and in 2021 for the treatment of EDS in adult patient with obstructive sleep apnea. We acquired an exclusive license to develop, manufacture and commercialize pitolisant in the United States pursuant to our license agreement with Bioprojet (as amended, the “2017 LCA”) in July 2017. Pitolisant was granted Orphan Drug Designation for the treatment of narcolepsy by the FDA in 2010. It received Breakthrough Therapy designation for the treatment of cataplexy in patients with narcolepsy and Fast Track status for the treatment of EDS and cataplexy in patients with narcolepsy in April 2018.
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Our operating subsidiary, Harmony Biosciences, LLC, was formed in May 2017. We were formed in July 2017 as Harmony Biosciences II, LLC, a Delaware limited liability company, and we converted to a Delaware corporation named Harmony Biosciences II, Inc. in September 2017. In February 2020, we changed our name to Harmony Biosciences Holdings, Inc. Our operations to date have consisted of building and staffing our organization, acquiring the rights to pitolisant, raising capital, opening an investigational new drug applications (“IND”) for pitolisant in narcolepsy, conducting an Expanded Access Program (“EAP”) for pitolisant for appropriate patients with narcolepsy in the United States, preparing and submitting our NDA for pitolisant, gaining NDA approval for WAKIX for the treatment of EDS or cataplexy in adult patients with narcolepsy, and launching and commercializing WAKIX in the United States. In addition, we have opened INDs for the development of WAKIX/pitolisant in PWS, DM and IH and have initiated clinical trials in pursuit of potential new indications in those rare disease patient populations.
Commercial Performance Metrics
As of September, 30 2022, we continue to see growth in unique healthcare professional (“HCP”) prescribers of WAKIX. The average number of patients on WAKIX for the three months ended September 30, 2022 was approximately 4,600. Additionally, as of September 30, 2022, we have secured formulary access for more than 80% of all insured lives (Commercial, Medicare and Medicaid) in the United States. Within these covered lives, we have observed favorable access to WAKIX subsequent to the expanded approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy in October 2020.
COVID-19 Business Update
During the COVID-19 pandemic, we developed a response strategy that included establishing cross-functional response teams and implementing business continuity plans to manage the impact of the pandemic on our employees, patients, HCPs, and our business.
Despite our response strategy, the COVID-19 pandemic has had an effect on our business and the pharmaceutical industry in general. Although the pandemic has impacted the way stakeholders interact with one another, we have leveraged technology and virtual engagement initiatives to offset our reduced in-person access to HCPs. The COVID-19 pandemic also led to high unemployment and corresponding loss of medical insurance for many patients, caused a change in relationship dynamics between patients and their HCPs, and impacted the way patients took, or did not take, their medication. As a result, we were not able to adequately gauge our growth rate and believe that our growth may be adversely impacted in the future if there is a reemergence or future outbreak of COVID-19, including any COVID-19 variant.
We intend to maintain meaningful engagement, generate awareness and educate our patients, HCPs and payors to support our commercial performance.
Commercialization
With respect to our commercialization activities, we believe the COVID-19 pandemic has put pressure on top-line prescription demand for WAKIX, primarily due to (i) our field sales team’s reduced ability to access HCPs in person, and (ii) fewer patients seeing HCPs for prescriptions or treatments. The impact on demand for WAKIX may have also been related to a reduced ability of prescribers to diagnose narcolepsy patients given the limitations in access to sleep testing, the reduced ability to see patients due to (i) cancelled appointments and (ii) the reprioritization of healthcare resources toward the treatment of COVID-19, both of which lead to fewer prescriptions. Despite these challenges, we continued to engage and educate HCPs virtually on the overall benefit/risk profile of WAKIX and continued to provide support for people living with narcolepsy. As offices, clinics and institutions have increased in-person interactions pursuant to health authority and local government guidelines, our field teams are re-initiating in-person interactions with HCPs and customers, but the timing and level of engagement may vary by account and region and may be adversely impacted in the future where reemergence or future outbreaks of COVID-19, including the rise of variants, may occur. Access to HCPs for our sales team is still limited and despite the opening up of the economy, we are still in a transition
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phase and expect continued, but decreasing, pressure on top line demand in future quarters as the challenges presented by COVID-19 begin to subside.
During the pandemic, elevated unemployment and the corresponding loss of health insurance caused some eligible patients to shift from commercial insurance to free drug and patient assistance programs, which impacted our ability to convert demand into revenue. Given the high unemployment rates and resulting loss of employer-sponsored insurance coverage, some patients also shifted from commercial payor coverage to government payor coverage, which may have impacted, and may continue to impact, our net revenue.
Supply Chain
We currently expect to have adequate supply of WAKIX into the first quarter of 2024, with additional API on-hand inventory to support at least 36 months beyond this time frame. We continue to work closely with our third-party manufacturers, distributors and other partners to manage our supply chain activities and mitigate potential disruptions to our product supplies as a result of the COVID-19 pandemic. We believe that our access to the required production lines to produce additional API and WAKIX finished product throughout the next 12 to 18 months would not be significantly impacted should there be a need to reprioritize manufacturing resources for the production of materials utilized for COVID-19 vaccines.
Our manufacturing partners in France and the United States continue to be operational. If there is a subsequent outbreak of COVID-19, or if it reemerges for an extended period of time and/or begins to impact essential distribution systems such as transatlantic freight, FedEx, UPS and postal delivery, we may experience disruptions to our supply chain and operations with associated delays in the manufacturing and supply of our products.
Research and Development
The COVID-19 pandemic has negatively impacted the pharmaceutical industry’s ability to conduct clinical trials and this impact was recently accentuated with the emergence of the Omicron variant during the second half of 2021. As a result of some challenges that we have experienced due to the COVID-19 pandemic, we have taken measures and put contingency plans in place in order to advance our clinical development programs. We implemented remote and virtual approaches to clinical trials, including the ability to perform screening remotely and allow electronic signatures on informed consent forms, using telemedicine for remote clinic visits to perform efficacy assessments and sending out licensed HCPs to patients to collect safety assessments (e.g. labs, electrocardiograms) as required by the protocols. We performed and continue to perform remote site visits and data monitoring where possible. These measures were instituted with the intent of maintaining patient safety and trial continuity while preserving study integrity. One unique challenge we continue to face is the ability to access sleep labs during the COVID-19 pandemic in order to conduct objective sleep testing, which is required for some of our clinical trials. In addition, we rely on contract research organizations (“CROs”) or other third parties to assist us with clinical trials, and we cannot guarantee that they will continue to perform their contractual duties in a timely and satisfactory manner as a result of the COVID-19 pandemic. The COVID-19 pandemic has also affected us at the clinical trial site level due to staffing shortages and/or personnel being pulled off clinical trials to care for patients with COVID-19. In addition, the COVID-19 pandemic has resulted in a significant increase in FDA workload as well as the need to reprioritize the projects under review. As a result, we may continue to experience delays in FDA timelines along the course of the regulatory process (e.g. milestone meetings) and PDUFA action dates. If there is a subsequent outbreak of COVID-19 or any variant thereof or if it reemerges for an extended period of time in the future, we may experience significant delays in our clinical development timelines, which would. adversely affect our business, financial condition, results of operations and growth prospects.
Corporate Development and Other Financial Impacts
The COVID-19 pandemic evolved rapidly and caused a significant disruption of domestic and global financial markets. In addition, the pandemic limited our ability to conduct in-person due diligence and other
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interactions to identify new opportunities. If there is a subsequent outbreak of COVID-19 or any variant thereof or if it reemerges for an extended period of time, we may be unable to access additional capital, which could negatively affect our ability to execute on certain corporate development transactions or other important investment opportunities.
The COVID-19 pandemic has also affected, and may continue to affect, our business operations and financial results. The extent of the impact of the COVID-19 pandemic or the potential impact of a reemergence or outbreak of the pandemic on our ability to generate sales of, and revenues from, our approved products, our clinical development and regulatory efforts, our corporate development objectives and the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time.
Corporate Responsibility Impact
We strive to attract and retain employees that are dedicated to keeping patients at the heart of all we do while also supporting the communities where we live and work. Our commitment toward this objective has been exemplified during the COVID-19 crisis. At the onset of the pandemic we took steps to ensure the health, safety and welfare of our employees and their families by abiding by government-issued work-from-home orders and encouraging a flexible work environment, and implementing a COVID-19 leave policy allowing for paid leave for employees affected by the virus outside of their accrued paid leave. We also made no furloughs, layoffs, or adjustments to salaries as a result of the pandemic. As pandemic-related restrictions and cases began to decline, all of our employees returned to in-person operations, with flexibility as needed, which we believe is critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances our culture. We continually look for ways to support our employees in all roles across the organization in balancing their work and personal lives.
Our commitment extends beyond ensuring that our employees are supported to supporting the communities where we live and work. We have contributed to relief efforts in our local communities, to patient-focused organizations and other charitable organizations during the COVID-19 pandemic, including corporate donations, food and medical supplies and other resources. We made charitable contribution matches to local nonprofit organizations on behalf of our employees, further extending our charitable reach. We initiated our Progress at the Heart funding program to support nonprofit organizations in their efforts to address disparities, injustice and inequities in rare neurological disease diagnosis and treatment. These commitments collectively allow us to ensure that our employees are engaged in their communities in ways that make a lasting impact.
Financial Operations Overview
Revenue
Net product sales includes gross sales of WAKIX less provisions for sales discounts and allowances, which includes trade allowances, rebates to government and commercial entities, and discounts. Although we expect net sales to increase over time, the provisions for sales discounts and allowances may fluctuate based on the mix of sales to different customer segments and/or changes in our estimates.
Cost of Product Sales
Cost of product sales includes manufacturing and distribution costs, the cost of the drug substance, FDA program fees, royalties due to third parties on net product sales, freight, shipping, handling, storage costs and salaries of employees involved with production. Our cost of product sales is increasing moderately as we continue to ramp up production and sales infrastructure to meet expected demand for WAKIX.
The shelf life of WAKIX is three years from date of manufacture, with the earliest expiration of current inventory expected to be May 2023. We regularly review our inventory levels and expect write-offs from time to
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time. We will continue to assess inventory levels in future periods as demand for WAKIX and the rate of inventory turnover evolves.
Research and Development Expenses
Research and development expenses generally include development programs for potential new indications for pitolisant in patients with IH, PWS and DM. We also incur research and development expenses related to our team of Medical Science Liaisons (“MSLs”) who interact with key opinion leaders, with a focus on the science, the role of histamine in sleep-wake state stability and the novel mechanism of action of pitolisant. In addition, our MSLs support our market access team with clinical data presentations to payors upon request and our clinical development team to identify potential clinical trial sites. Research and development costs are expensed as incurred. We have significantly increased our research and development efforts as we advance our clinical programs in IH, PWS and DM and assess other product candidates to expand our pipeline. Research and development expenses also include:
| ● | employee-related expenses, such as salaries, share-based compensation, benefits and travel expenses for our research and development personnel; |
| ● | direct third-party costs such as expenses incurred under agreements with CROs, and contract manufacturing organizations (“CMOs”); |
| ● | manufacturing costs in connection with producing materials for use in conducting clinical trials; |
| ● | costs related to packaging and labelling of clinical supplies; |
| ● | other third-party expenses (i.e., consultants, advisors) directly attributable to the development of our product candidates; and |
| ● | amortization expense for assets used in research and development activities. |
We do not track research and development expenses on an indication-by-indication basis. A significant portion of our research and development costs are external costs, such as fees paid to CROs and CMOs, central laboratories, contractors, and consultants in connection with our clinical development programs. Internal expenses primarily relate to personnel who are deployed across multiple programs.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, milestone payments, and the cost of submitting an NDA to the FDA (and/or other regulatory authorities). We expect our research and development expenses to be significant over the next several years as we advance our current clinical development programs and prepare to seek regulatory approval for additional indications for pitolisant, advance HBS-102 from preclinical studies into the clinic, and identify potential new product candidates to develop toward new indications.
At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any additional indications for pitolisant or other product candidates that we move forward for regulatory approval. There are numerous risks and uncertainties associated with developing product candidates, including uncertainty related to:
| ● | the duration, costs and timing of clinical trials of our current development programs and any further clinical trials related to new product candidates; |
| ● | the sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; |
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| ● | the impact of the COVID-19 pandemic, including any future resurgence or new variants, on the ability to initiate new clinical trials and/or maintain the continuity of ongoing clinical trials that could be impacted by future shelter-in-place orders and needs of the health care system to focus on managing patients affected by COVID-19; |
| ● | receiving Bioprojet’s consent to pursue additional indications for pitolisant; |
| ● | the acceptance of INDs for our planned clinical trials or future clinical trials; |
| ● | the successful and timely enrollment and completion of clinical trials; |
| ● | the successful completion of preclinical studies and clinical trials; |
| ● | successful data from our clinical programs that support an acceptable risk-benefit profile of our product candidates in the intended populations; |
| ● | the receipt and maintenance of regulatory and marketing approvals from applicable regulatory authorities; |
| ● | establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidate is approved; |
| ● | the entry into collaborations to further the development of our product candidates; |
| ● | obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates; and |
| ● | successfully launching our product candidates and achieving commercial sales, if and when approved. |
A change in the outcome of any of these variables with respect to the development of any of our programs or any product candidate we develop would significantly change the costs, timing and viability associated with the development and/or regulatory approval of such programs or product candidates.
Sales and Marketing Expenses
Our sales and marketing expenses primarily relate to the market development and commercialization activities of WAKIX for the treatment of EDS and cataplexy in adult patients with narcolepsy. Market development and commercial activities account for a significant portion of our operating expenses and are expensed as incurred. We expect our sales and marketing expenses to increase in the near- and mid-term to support our indications for the treatment of EDS or cataplexy in adult patients with narcolepsy and to expand our portfolio with the anticipated growth from potential additional indications.
Sales and marketing expenses include:
| ● | employee-related expenses, such as salaries, share-based compensation, benefits and travel expenses for our sales and marketing personnel; |
| ● | healthcare professional-related expenses, including marketing programs, healthcare professional promotional medical education, disease education, conference exhibits and market research; |
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| ● | patient-related expenses, including patient awareness and education programs, disease awareness education, patient reimbursement programs, patient support services and market research; |
| ● | market access expenses, including payor education, specialty pharmacy programs and services to support the continued commercialization of WAKIX; and |
| ● | secondary data purchases (i.e., patient claims and prescription data), data warehouse development and data management. |
In addition, sales and marketing expenses include external costs such as website development, media placement fees, agency fees for patient, medical education and promotional expenses, market research, analysis of secondary data, conference fees and consulting fees.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, benefits and travel expenses for our personnel in executive, legal, finance and accounting, human resources, investor relations, and other administrative departments. General and administrative expenses also consist of office leases, and professional fees, including legal, tax and accounting and consulting fees.
We anticipate that our general and administrative expenses will increase in the future to support our continued commercialization efforts, ongoing and future potential research and development activities, and increased costs of operating as a public company. These increases will likely be driven by costs associated with the hiring of additional personnel and fees paid to outside consultants, lawyers and accountants, among other expenses. Additionally, we anticipate increased costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the SEC, insurance and investor relations costs. If any of our current or future indication expansion programs or new product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.
Paragon Agreements
We were party to a management services agreement with Paragon Biosciences, LLC (“Paragon”), which was terminated upon the consummation of our IPO, pursuant to which Paragon provided us with certain professional services.
We are also party to a right-of-use agreement with Paragon whereby we have access to and the right to use certain office space leased by Paragon in Chicago, Illinois. For the three and nine months ended September 30, 2022, we paid $0.1 million and $0.2 million, respectively, pursuant to this agreement.
Interest Expense, Net
Interest expense, net consists primarily of interest expense on debt facilities, amortization of debt issuance costs and amortization of premiums on our debt securities, partially offset by interest income earned on our cash and investment balances and accretion of discounts on our debt securities.
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Results of Operations
The following table sets forth selected items in our unaudited condensed consolidated statements of operations for the periods presented:
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||
(In thousands) | (In thousands) | |||||||||||
Net product revenue | $ | 117,206 | $ | 80,732 | $ | 309,547 | $ | 214,227 | ||||
Cost of product sales |
| 22,959 |
| 14,604 |
| 56,596 |
| 37,701 | ||||
Gross profit |
| 94,247 |
| 66,128 |
| 252,951 |
| 176,526 | ||||
Operating expenses: |
|
|
|
|
|
|
|
| ||||
Research and development |
| 40,548 |
| 11,739 |
| 60,794 |
| 22,916 | ||||
Sales and marketing |
| 20,467 |
| 16,480 |
| 58,210 |
| 49,009 | ||||
General and administrative |
| 21,331 |
| 16,856 |
| 61,374 |
| 45,704 | ||||
Total operating expenses |
| 82,346 |
| 45,075 |
| 180,378 |
| 117,629 | ||||
Operating income |
| 11,901 |
| 21,053 |
| 72,573 |
| 58,897 | ||||
Loss on debt extinguishment |
| — |
| (26,146) |
| — |
| (26,146) | ||||
Other expense (income), net |
| 56 |
| — |
| 96 |
| (15) | ||||
Interest expense, net |
| (3,990) |
| (5,429) |
| (12,086) |
| (19,783) | ||||
Net income before provision for income taxes |
| 7,967 |
| (10,522) |
| 60,583 |
| 12,953 | ||||
Income tax benefit (expense) |
| 79,976 |
| 902 |
| 72,376 |
| (1,070) | ||||
Net income | $ | 87,943 | $ | (9,620) | $ | 132,959 | $ | 11,883 | ||||
Net Product Revenue
Net product revenue increased by $36.5 million, or 45.2%, for the three months ended September 30, 2022 and increased by $95.3 million, or 44.5%, for the nine months ended September 30, 2022, compared to the same periods in 2021. The increase in both comparable periods was due to the growth in the average number of patients on WAKIX and price increases.
Cost of Product Sales
Cost of product sales increased by $8.4 million, or 57.2%, for the three months ended September 30, 2022 and increased by $18.9 million, or 50.1%, for the nine months ended September 30, 2022, compared to the same periods in 2021. The increase in both comparable periods was due to higher sales of WAKIX. Cost of product sales is primarily comprised of the royalty to Bioprojet.
Research and Development Expenses
Research and development expenses increased by $28.8 million, or 245.4%, for the three months ended September 30, 2022, and increased by $37.9 million, or 165.3%, for the nine months ended September 30, 2022, compared to the same periods in 2021. The increase for the three months ended September 30, 2022 is primarily related to the $30 million licensing fee incurred upon entering the 2022 LCA with Bioprojet. The increase for the nine months ended September 30, 2022 is primarily driven by the $30 million licensing fee as well as increased clinical development work associated with IH, PWS and DM and increased personnel costs.
Sales and Marketing Expenses
Sales and marketing expenses increased by $4.0 million, or 24.2%, for the three months ended September 30, 2022, and increased by $9.2 million, or 18.8%, for the nine months ended September 30, 2022,
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compared to the same periods in 2021. The increase in both comparable periods was primarily due to patient engagement and marketing activities driven by our commercialization of WAKIX and increased personnel costs related to sales force expansion.
General and Administrative Expenses
General and administrative expenses increased by $4.5 million, or 26.5%, for the three months ended September 30, 2022 and increased by $15.7 million, or 34.3%, for the nine months ended September 30, 2022, as compared to the same periods in 2021. The increase in both comparable periods was primarily due to an increase to stock compensation associated with new awards, an increase in intangible asset amortization as a result of the $40.0 million milestone payment upon attaining $500.0 million in life-to-date aggregate net sales of WAKIX in the United States and an increase in personnel costs.
Loss on Debt Extinguishment
There were no extinguishments of debt for the three and nine months ended September 30, 2022. Loss on debt extinguishment was $26.1 million for the three and nine months ended September 30, 2021, due to the prepayment of the Credit Agreement with OrbiMed.
Interest Expense, Net
Interest expense, net decreased by $1.4 million, or 26.5%, for the three months ended September 30, 2022 and decreased by $7.7 million, or 38.9%, for the nine months ended September 30, 2022, compared to the same periods in 2021 primarily due to lower interest rates as a result of entering into the Blackstone Credit Agreement in August 2021 as compared to our previous Credit Agreement with OrbiMed, partially offset by interest income generated from our investments and an increase to the LIBOR.
Income Taxes
Income tax benefit increased $79.1 million for the three months ended September 30 2022, and increased $73.4 million for the nine months ended September 30, 2022, as compared to the same periods in 2021. The increase in both comparable periods was primarily driven by the release of our valuation allowance against our net deferred tax assets.
Liquidity, Sources of Funding and Capital Resources
Overview
To date, we have financed our operations primarily with (a) proceeds from sales of our convertible preferred stock; (b) borrowings under our (i) CRG Loan, (ii) our Credit Agreement with OrbiMed and (iii) our Blackstone Credit Agreement; (c) the proceeds from our IPO; and (d) the proceeds from the sale of common stock to Blackstone. From our inception through our IPO, we received aggregate proceeds of $345.0 million from sales of our convertible preferred stock. In August 2020, we completed the IPO of our common stock, in which we sold 6,151,162 shares of our common stock, including 802,325 shares of our common stock pursuant to the underwriters’ over-allotment option. The shares were sold at a price of $24.00 per share for net proceeds of approximately $135.4 million. As of September 30, 2022, we had cash, cash equivalents, restricted cash and investments of $316.8 million and accumulated deficit of $320.6 million. As of September 30, 2022, we had outstanding debt of $198.0 million.
We have invested a portion of our available cash in money market funds, U.S. government and agency securities, corporate bonds and commercial paper in accordance with our investment policy. Our investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of our investments to preserve principal and maintain liquidity. All investment securities have a credit
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rating of at least A-2/P-2/F2 from at least two National Recognized Statistical Rating Organizations. Our investment portfolio may be adversely impacted by future disruptions in the credit markets.
The unaudited condensed consolidated financial statements have been prepared as though we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
We believe that our anticipated cash from operating and financing activities, including as a result of potential availability under the DDTL (defined below), existing cash and cash equivalents and investments will enable us to meet our operational liquidity needs and fund our planned investing activities for the next 12 months. We have based this estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we expect.
Blackstone Credit Agreement
In August 2021, we entered into the Blackstone Credit Agreement that provides for (i) a senior secured term loan facility in an aggregate original principal amount of $200.0 million (the “Initial Term Loan”) and (ii) a senior secured delayed draw term loan facility in an aggregate principal amount up to $100.0 million (the “DDTL” and, together with the Initial Term Loans, the “Loans”). The DDTL was initially available to draw down through August 9, 2022. In August 2022, we entered into an agreement to extend the expiration date of the DDTL to August 9, 2023, for which we will pay a ticking fee at a rate of 1% per annum on the undrawn portion of the DDTL, which commenced on August 10, 2022. We used substantially all of the proceeds from the Blackstone Credit Agreement, and the related sale of our common stock, to repay the balance of the OrbiMed Credit Agreement.
The repayment schedule for the Initial Loan consists of quarterly $0.5 million principal payments commencing on December 31, 2021 and increasing to quarterly $5 million payments beginning on March 31, 2024, with a $145.5 million payment due on the maturity date of August 9, 2026 (“Maturity Date”). Interest is payable quarterly commencing on November 9, 2021 and continuing through the Maturity Date. The Initial Term Loan bears interest at a per annum rate equal to LIBOR, subject to a 1.00% floor, plus 6.50%. The Loans are guaranteed by our subsidiary Harmony Biosciences, LLC.
The Blackstone Credit Agreement contains affirmative and negative covenants, including limitations on our ability, among other things, to incur additional debt, grant or permit additional liens, make investments and acquisitions, merge or consolidate with others, dispose of assets, pay dividends and distributions and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the Blackstone Credit Agreement contains a financial covenant that requires us to maintain at all times cash and cash equivalents in certain deposit accounts in an amount at least equal to $10.0 million. We are in compliance with all covenants as of September 30, 2022.
Agreement Related to Intellectual Property
In August 2021, we entered into an asset purchase agreement with ConSynance Therapeutics, Inc. to acquire HBS-102 (formerly “CSTI-100”), a potential first-in-class molecule with a novel mechanism of action. Under the terms of the agreement, we acquired full development and commercialization rights globally, with the exception of Greater China, for $3.5 million. Additionally, there are payments due upon the achievement of certain milestones including $1.8 million for preclinical milestones, $19.0 million for development milestones, $44.0 million for regulatory milestones and $110.0 million for sales milestones.
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License Agreement
On July 31, 2022, we entered into the 2022 LCA with Bioprojet whereby we obtained exclusive rights to manufacture, use and commercialize one or more new products based on pitolisant in the United States and Latin America, with the potential to add additional indications and formulations upon agreement of both parties. We will pay an initial, non-refundable $30 million licensing fee and additional payments of up to $155 million are potentially due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, there are certain payments due upon achievement of development milestones for new indications and formulations agreed upon by both parties. The 2022 LCA also requires a fixed trademark royalty and a tiered royalty based on net sales upon commercialization, which will be payable to Bioprojet on a quarterly basis. Upon closing of the 2022 LCA on September 28, 2022, the $30 million licensing fee was recorded in research and development within the unaudited condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2022.
Recent Milestone Payment
Upon FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy in October 2020 (the “Cataplexy Milestone Trigger Date”), we became obligated to make the $100.0 million milestone payment (the “Cataplexy Milestone Payment”) to Bioprojet under the provisions of the 2017 LCA. Subsequently, in October 2020, we made a payment to Bioprojet of $2.0 million to extend the Cataplexy Milestone Payment due date to within 90 days of the Cataplexy Milestone Trigger Date. In January 2021, we made the $100.0 million Cataplexy Milestone Payment in full to Bioprojet. In addition, we made a final $40.0 million milestone payment to Bioprojet in March 2022 upon WAKIX attaining $500.0 million in life-to-date aggregate net sales in the United States.
Cash Flows
The following table sets forth a summary of our cash flows for the nine months ended September 30, 2022 and 2021:
Nine Months Ended September 30, | ||||||
| 2022 |
| 2021 | |||
Selected cash flow data | (In thousands) | |||||
Cash provided by (used in): |
|
|
|
| ||
Operating activities | $ | 117,788 | $ | 61,024 | ||
Investing activities |
| (94,937) |
| (100,298) | ||
Financing activities |
| 4,183 |
| 347 | ||
Operating Activities
Net cash provided by operating activities for the nine months ended September 30, 2022 consisted of our net income of $133.0 million adjusted for non-cash items of $81.7 million related to deferred tax assets, $17.3 million related to intangible amortization and depreciation and $19.2 million related to stock-based compensation expense. Net working capital excluding cash increased by $27.9 million, which was partially due to the accrual of the $30.0 million licensing fee associated with the 2022 LCA.
Net cash provided by operating activities for the nine months ended September 30, 2021 consisted of our net income of $11.8 million adjusted for non-cash items of $26.1 million related to loss on extinguishment of debt, $14.0 million related to intangible amortization and depreciation and $11.7 million related to stock-based compensation expense. Net working capital excluding cash decreased by $4.6 million.
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Investing Activities
Net cash used in investing activities for the nine months ended September 30, 2022 was $94.9 million, which was primarily attributable to a final $40.0 million milestone payment associated with the 2017 LCA and $55.6 million in purchases of debt securities, partially offset by $0.9 million in proceeds from sales and maturities of investments.
Net cash used in investing activities for the nine months ended September 30, 2021 was $100.3 million, which was primarily attributable to the $100.0 million milestone payment associated with the 2017 LCA.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2022 was $4.2 million, which primarily consisted of $5.3 million in proceeds from exercised options offset by $1.5 million in principal payments associated with the Blackstone Credit Agreement.
Net cash provided by financing activities for the nine months ended September 30, 2021 was $0.3 million, which primarily consisted of $190.9 million in proceeds associated with the Blackstone Credit Agreement, net of issuance costs, and $29.7 million in proceeds associated with issuance of common stock to Blackstone, net of issuance costs. These proceeds were partially offset by $222.0 million in payments of principal and exit fees associated with the extinguishment of the OrbiMed Credit Agreement.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we evaluate our estimates and judgments on an ongoing basis.
Significant estimates include assumptions used in the determination of some of our costs incurred under our services type agreements and which costs are charged to research and development and general and administrative expense. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting policies as those under GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the quarter covered by this report, there were no material changes to the accounting policies and assumptions previously disclosed, except as disclosed in Note 3 to the unaudited condensed consolidated financial statements contained herein.
Recent Accounting Pronouncements
See Note 3 to our unaudited condensed consolidated financial statements for recent accounting pronouncements.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Fluctuation Risk
We are exposed to market risk related to changes in interest rates. We invest a portion of our cash in investment-grade, interest-bearing securities. The primary objectives of our investment activities are to preserve principal, maintain liquidity and maximize total return. In order to achieve these objectives, we invest in money market funds, U.S. government and agency securities, corporate bonds and commercial paper in accordance with our investment policy. Our investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of our investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least A-2/P-2/F2 from at least two National Recognized Statistical Rating Organizations. We do not have any direct investments in asset-backed securities, collateralized debt or loan obligations, or structured investment vehicles. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. Based on our $235.2 million of investments in money market funds, U.S. treasury notes, corporate bonds and municipal obligations as of September 30, 2022, an immediate 10% change in market interest rates would not have a material impact on the fair market value of our investment portfolio or on our financial position or results of operations.
As of September 30, 2022, we had $198.0 million in borrowings outstanding. The Initial Term Loan bears interest at an interest rate equal to LIBOR (subject to a 1.00% floor) plus 6.50%. Based on the $198.0 million of principal outstanding as of September 30, 2022, an immediate 10% change in the LIBOR would not have a material impact on our debt-related obligations, financial position or results of operations.
Foreign Currency Fluctuation Risk
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates; however, we have contracted with and may continue to contract with foreign vendors that are located in Europe. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.
Inflation Fluctuation Risk
Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation had a material effect on our business, financial condition or results of operations for the three and nine months ended September 30, 2022 and 2021.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, including our principal executive officer and our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of September 30, 2022. Based on that evaluation, our principal executive officer and principal financial officer concluded that, as of September 30, 2022, our disclosure controls and procedures were effective to provide reasonable assurance that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
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Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
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. 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. 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. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations or financial condition.
Item 1A. Risk Factors.
In addition to the other information included in this report, you should carefully consider the discussion of risk factors affecting the Company as set forth in Part I, Item 1A "Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2021, which could materially affect our business, financial condition or future results. The risks described in these reports are not the only risks facing the Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, and operating results.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
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Item 6. Exhibits.
Exhibit | Incorporated by Reference | |||||||
No. |
| Exhibit Description |
| Form |
| Date |
| Number |
3.1 | Amended and Restated Certificate of Incorporation of Harmony Biosciences Holdings, Inc. | 8-K | August 21, 2020 | 3.1 | ||||
3.2 | 8-K | August 21, 2020 | 3.2 | |||||
10.1*+ | ||||||||
10.2* | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1** | ||||||||
32.2** | ||||||||
101* | The following financial statements from the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022 formatted in Inline XBRL: (i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Stockholders’ Equity and (vi) Notes to Financial Statements, tagged as blocks of text and including detailed tags. | |||||||
104* | Cover Page Interactive Date File (formatted as Inline XBRL and contained in Exhibit 101) | |||||||
* | Filed herewith. |
** | Furnished herewith. 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. 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 Quarterly Report on Form 10-Q, 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). |
37
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
HARMONY BIOSCIENCES HOLDINGS, INC. | |||
By: | /s/ John C. Jacobs | ||
Name: |
| John C. Jacobs | |
Title: | President, Chief Executive Officer and Director (principal executive officer) | ||
Date: |
| November 1, 2022 | |
By: |
| /s/ Sandip Kapadia | |
Name: |
| Sandip Kapadia | |
Title: | Chief Financial Officer (principal financial officer) | ||
Date: |
| November 1, 2022 | |
38
Certain identified information has been omitted from this document because it is not material and would be competitively harmful if publicly disclosed, and has been marked with “[***]” to indicate where omissions have been made.
LICENSE AND COMMERCIALIZATION AGREEMENT
THIS LICENSE AND COMMERCIALIZATION AGREEMENT (“Agreement”) dated as of July 31, 2022 (“Signing Date”) is entered into between Bioprojet Société Civile de Recherche, an independent (privately owned) research company organized under the laws of France and having its principal place of business at 30, rue des Francs-Bourgeois, 75003 Paris, France (together with its Affiliates, including Bioprojet Pharma SAS and Bioprojet Europe Ltd., “Bioprojet”) and Harmony Biosciences, LLC, a limited liability company organized under the laws of Delaware and having its principal place of business at 630 W. Germantown Pike, Suite 215, Plymouth Meeting, Pennsylvania, USA (“Harmony”).
BACKGROUND
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
| Article 1 | |
DEFINITIONS
In addition to the capitalized terms defined elsewhere in this Agreement, the following terms shall have the meanings set forth below, except as otherwise provided herein.
| Article 2 | |
GRANT OF LICENSES
| Article 3 | |
GOVERNANCE
| Article 4 | |
DEVELOPMENT, CLINICAL, REGULATORY AND MEDICAL AFFAIRS ACTIVITIES
This exchange of information shall be governed by the Safety Data Exchange Agreement (“SDEA”) agreed between the Parties under the LCA, as amended by the Parties at the Effective Date or within [thirty (30) days] thereafter to incorporate the Product(s) and each Party agrees to the timely exchange of safety data as outlined in the SDEA.
| Article 5 | |
COMMERCIALIZATION AND PROMOTION
| Article 6 | |
PAYMENTS
[***].
Annual Net Sales |
| Royalty Rate (% of |
| |
[***] |
|
| [***] | |
[***] | | | [***] | |
[***] | | | [***] | |
[***] | | | [***] | |
Worked example: [***]
| o | [***] |
and
(a) and (b) together the “Royalty Payments”.
In addition to the Royalty Payments and in consideration for the Trademark License, following the First Commercial Sale of a Product and for twenty (20) years thereafter, Harmony shall pay to Bioprojet royalties on Annual Net Sale of Products in the Harmony Territory at a rate equal to [***] (“Trademark Royalty Payments”).
| Article 7 | |
PAYMENTS; BOOKS AND RECORDS
| Article 8 | |
CERTAIN COVENANTS
| Article 9 | |
PRODUCT SUPPLY AND DISTRIBUTION
| Article 10 | |
CONFIDENTIALITY
| Article 11 | |
PATENT PROSECUTION AND ENFORCEMENT
[***]
| Article 12 | |
TRADEMARKS
[***] | | | | | | | | |
| | | | | | | | |
| Article 13 | |
TERM AND TERMINATION
| Article 14 | |
EFFECT OF TERMINATION
| Article 15 | |
REPRESENTATIONS, WARRANTIES AND COVENANTS
| Article 16 | |
INDEMNIFICATION
| Article 17 | |
CLOSING
| Article 18 | |
EXCLUSIVITY
| Article 19 | |
DISPUTE RESOLUTION
| Article 20 | |
GENERAL PROVISIONS
To Bioprojet: |
| To Harmony: |
Bioprojet Société Civile de Recherche 75003 Paris, France Attention: [***] |
| Harmony Biosciences, LLC 630 W. Germantown Pike, Suite 215, Plymouth Meeting, Pennsylvania, USA |
With a copy to: |
| With a copy to: |
McDermott Will & Emery AARPI 23 rue de l’Université 75007 Paris, France Attention: Emmanuelle Trombe [***] |
| Hogan Lovells US LLP 100 International Drive Baltimore, Maryland 21208 USA Attention: William Intner [***] |
Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed.
[Signature Page Follows]
IN WITNESS WHEREOF, the Parties have executed this License and Commercialization Agreement as of the date first set forth above.
|
| Bioprojet Société Civile de Recherche | ||
| BY: | | /s/ Jeanne-Marie Lecomte | |
| NAME: |
| Jeanne-Marie Lecomte | |
| TITLE: |
| Chairman | |
| Harmony Biosciences, LLC | |||
| BY: |
| /s/ John Jacobs | |
| NAME: |
| John Jacobs | |
| TITLE: |
| President & CEO | |
EXHIBIT 1.11
Bioprojet Patents
EXHIBIT 3.1(a)
Initial Development Plan
[***]
Exhibit 10.2
Execution Version
AMENDMENT NO. 1 TO CREDIT AGREEMENT
THIS AMENDMENT NO. 1 TO CREDIT AGREEMENT, dated as of August 2,
2022 (this “Amendment”), is by and among HARMONY BIOSCIENCES HOLDINGS, INC., a Delaware corporation (the “Borrower”), its wholly owned subsidiary, HARMONY BIOSCIENCES, LLC, a Delaware limited liability company (“Harmony”), as the sole initial Guarantor and the Lenders (as defined in the Credit Agreement referred to below).
WITNESSETH
WHEREAS, the Borrower, Harmony, the Lenders and WILMINGTON TRUST, NATIONAL ASSOCIATION, as Administrative Agent (as defined therein) are party to that certain Credit Agreement, dated as of August 9, 2021 (as amended, restated, amended and restated, supplemented or otherwise modified from time to time, the “Credit Agreement”, the Credit Agreement as amended by this Amendment, the “Amended Document”); and
WHEREAS, the parties have agreed to amend certain provisions of the Credit Agreement as hereinafter provided, in each case, subject to the satisfaction of the conditions precedent to effectiveness set forth in Section 3 hereof.
NOW THEREFORE, in consideration of the foregoing and the mutual agreements and covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
SECTION 1 Definitions; Interpretation.
SECTION 2Amendments.
| (iii) | “Ticking Fee” has the meaning specified therefor in Section 2.07(c). |
2.07(c).
| (iv) | “Ticking Fee Accrual Period” has the meaning specified therefor in Section |
| (b) | The definition of “Outside Date” in Section 1.01 of the Credit Agreement |
is hereby amended and restated in its entirety as follows:
“Outside Date” means August 9, 2023 or such later date as may be agreed by the Lender Representative and the Borrower in their sole discretion and notified by the Borrower or the Lender Representative to the Administrative Agent in writing.”
“(c) Ticking Fee. From and after August 10, 2022 and until the last day of the Delayed Draw Availability Period (the “Ticking Fee Accrual Period”), the Borrower shall pay to the Administrative Agent for the account of each Lender with a Delayed Draw Commitment, in accordance with its pro rata share, a ticking fee (the “Ticking Fee”), which shall accrue daily on each day during the Ticking Fee Accrual Period at the rate per annum of 1.00% on the aggregate undrawn Delayed Draw Commitments of all Lenders. Accrued and unpaid Ticking Fees shall be payable upon each Borrowing of the Delayed Draw Loans and upon the expiration of the Delayed Draw Availability Period.”
SECTION 3 Conditions. The effectiveness of this Amendment is subject to the satisfaction of the following conditions precedent (the date on which the following conditions are satisfied or waived, the “First Amendment Effective Date”):
SECTION 4Miscellaneous.
(ii) the Lenders and the Administrative Agent reserve all rights, privileges and remedies under the Amended Document and the other Loan Documents.
[Remainder of page intentionally left blank; signature pages follow]
DocuSign Envelope ID: DE4B7423-D441-4F02-A273-9867166648B3
| BORROWER | HARMONY BIOSCIENCES HOLDINGS, INC. |
| | |
| | By: |
| | Name: John C. Jacobs |
| | Title: President and Chief Executive Officer |
| GUARANTOR | HARMONY BIOSCIENCES, LLC |
| | |
| | By: |
| | Name: John C. Jacobs |
| | Title: President and Chief Executive Officer |
[Signature Page to Amendment No. 1 to Credit Agreement]
| LENDERS | ALOE SUB LLC, |
| | as a Lender |
| | |
| | By: Aloe Top Sub LLC, its sole member |
| | By: Aloe Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | |
| | ALPACA SUB LLC, |
| | as a Lender |
| | |
| | By: Alpaca Top Sub LLC, its sole member |
| | By: Alpaca Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | |
| | BEGONIA SUB LLC, |
| | as a Lender |
| | |
| | By: Begonia Top Sub LLC, its sole member |
| | By: Begonia Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
[Signature Page to Amendment No. 1 to Credit Agreement]
| | CACTUS SUB LLC, |
| | as a Lender |
| | |
| | By: Cactus Top Sub LLC, its sole member |
| | By: Cactus Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | |
| | FERN SUB LLC, |
| | as a Lender |
| | |
| | By: Fern Top Sub LLC, its sole member |
| | By: Fern Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | |
| | GRASS SUB LLC, |
| | as a Lender |
| | |
| | By: Grass Top Sub LLC, its sole member |
| | By: Grass Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | HOLLY SUB LLC, |
| | as a Lender |
| | |
| | By: Holly Top Sub LLC, its sole member |
| | By: Holly Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
Title:Authorized Signatory
| | IVY SUB LLC, |
| | as a Lender |
| | |
| | By: Ivy Top Sub LLC, its sole member |
| | By: Ivy Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | MOSS SUB LLC, |
| | as a Lender |
| | |
| | By: Moss Top Sub LLC, its sole member |
| | By: Moss Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | POTHOS SUB LLC, |
| | as a Lender |
| | |
| | By: Pothos Top Sub LLC, its sole member |
| | By: Pothos Topco LP, its sole member |
| | By: BXC Azul Associates LLC, its general partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | GSO CREDIT ALPHA FUND II-C AIV-1, LP, |
| | as a Lender |
| | |
| | By: GSO Credit Alpha Associates II LP, its General Partner |
| | By: GSO Credit Alpha Associates II (Delaware) LLC, its General Partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | GSO CREDIT ALPHA FUND II-C AIV-4, LP, |
| | as a Lender |
| | |
| | By: GSO Credit Alpha Associates II LP, its General Partner |
| | By: GSO Credit Alpha Associates II (Delaware) LLC, its General Partner |
| | |
| | By: |
| | Name: Marisa Beeney |
| | Title:Authorized Signatory |
| | |
| | Title:Authorized Signatory |
Exhibit 31.1
Certification of Principal Executive Officer
I, John C. Jacobs, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Harmony Biosciences Holdings, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Exhibit 31.2
Certification of Principal Financial Officer
I, Sandip Kapadia, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of Harmony Biosciences Holdings, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 1, 2022 | | By: | /s/ Sandip Kapadia |
| | | Sandip Kapadia |
| | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
Exhibit 32.1
Certification of Principal Executive Officer
Pursuant To 18 U.S.C. Section 1350,
as Adopted Pursuant to
Section 906 of The Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q of Harmony Biosciences Holdings, Inc. (the “Company”) for the quarter ended September 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:
| (1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as a part of the Report or on a separate disclosure document.
Exhibit 32.2
Certification of Principal Financial Officer
Pursuant To 18 U.S.C. Section 1350,
as Adopted Pursuant to
Section 906 of The Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q of Harmony Biosciences Holdings, Inc. (the “Company”) for the period ended September 30, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to such officer’s knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as a part of the Report or on a separate disclosure document.