HRMY on Nasdaq

Harmony Biosciences Holdings, Inc.

Harmony Biosciences Holdings, Inc. is an American pharmaceutical preparations company based in Plymouth Meeting.1 Its shares trade on Nasdaq under the symbol HRMY.1

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Last updated Oct 21, 2026.

Overview

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  • TickerHRMY on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersPlymouth Meeting, Pennsylvania1
  • Incorporated inDE2
  • Business address630 W Germantown Pike, Suite 215, Plymouth Meeting, Pa 194622
  • Filer categoryLarge accelerated filer2

We are cultivating a differentiated neuroscience company, rooted in innovation and driven by a commitment to addressing the unmet needs of patients living with neurological diseases. To date, we have focused on rare neurological diseases with a growing portfolio now spanning sleep/wake, rare epilepsy, and neurobehavioral and we are harnessing scientific insights and pioneering approaches to advance meaningful treatments that help patients thrive.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

77.2%Gross margin5
24.0%Operating margin5
18.3%Net margin5
21.5%Revenue growth, 20255
18.2%Return on equity5
0.17×Debt to equity5
$347.9MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue23¢$198.3M
  • Research and development22¢$189.6M
  • Other costs31¢$265.5M
  • Income tax6¢$56.4M
  • Profit18¢$158.7M

Out of $868.5M in revenue.5

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$310.0K
  • Kept or used elsewhere100¢$347.9M

Out of $348.2M of cash from operations.5

Financial statements

Revenue67895$868.5M in 2025+14386% since 2019
0$250.0M$500.0M$750.0M$1.0B2019: $6.0M$6.0M20192020: $159.7M$159.7M2020+2565%2021: $305.4M$305.4M2021+91%2022: $437.9M$437.9M2022+43%2023: $582.0M$582.0M2023+33%2024: $714.7M$714.7M2024+23%2025: $868.5M$868.5M2025+22%
Gross profit67895$670.1M in 2025+15068% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $4.4M$4.4M20192020: $132.0M$132.0M2020+2888%2021: $249.9M$249.9M2021+89%2022: $354.4M$354.4M2022+42%2023: $460.8M$460.8M2023+30%2024: $557.9M$557.9M2024+21%2025: $670.1M$670.1M2025+20%
Operating income67895$208.5M in 2025
-$200.0M-$100.0M0$100.0M$200.0M$300.0M2019: -$145.9M-$145.9M20192020: $17.0M$17.0M20202021: $87.5M$87.5M2021+415%2022: $120.2M$120.2M2022+37%2023: $192.0M$192.0M2023+60%2024: $190.8M$190.8M2024−1%2025: $208.5M$208.5M2025+9%
Net income67895$158.7M in 2025
-$200.0M-$100.0M0$100.0M$200.0M2019: -$152.0M-$152.0M20192020: -$36.9M-$36.9M2020−76%2021: $34.6M$34.6M20212022: $181.5M$181.5M2022+425%2023: $128.9M$128.9M2023−29%2024: $145.5M$145.5M2024+13%2025: $158.7M$158.7M2025+9%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Net product revenue$868.5M$714.7M$582.0M
Cost of product sold$198.3M$156.8M$121.2M
Gross profit$670.1M$557.9M$460.8M
Sales and marketing$119.5M$110.9M$97.4M
General and administrative$152.5M$110.4M$95.3M
Total operating expenses$461.6M$367.1M$268.8M
Operating income$208.5M$190.8M$192.0M
Loss on debt extinguishment-$9.8M
Other (expense) income, net-$680.0K-$68.0K$159.0K
Interest expense-$14.6M-$17.5M-$23.8M
Interest income$21.9M$18.5M$14.7M
Income before income taxes$215.1M$191.8M$173.4M
Income tax expense-$56.4M-$46.3M-$44.5M
Net income$158.7M$145.5M$128.9M
Unrealized income on investments$280.0K$64.0K$153.0K
Comprehensive income$159.0M$145.6M$129.0M
Basic$2.76$2.56$2.17
Diluted$2.71$2.51$2.13
Weighted average number of shares of common stock - basic57.5M shares56.9M shares59.5M shares
Weighted average number of shares of common stock - diluted58.5M shares57.9M shares60.4M shares
Research and development$189.6M$145.8M$76.1M

Compare Harmony Biosciences Holdings, Inc. with another company

Corporate structure

Harmony Biosciences Holdings, Inc. sits at the top of its group. 6 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Harmony Biosciences Holdings, Inc.

  • VANGUARD PORTFOLIO MANAGEMENT LLC Filed SCHEDULE 13G on Harmony Biosciences Holdings, Inc., latest Jul 31, 2026
  • BlackRock Filed SCHEDULE 13G/A on Harmony Biosciences Holdings, Inc., latest Jul 28, 2026 (7 filings since Feb 4, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Harmony Biosciences Holdings, Inc., latest Mar 27, 2026 (4 filings since Feb 9, 2023)
  • FMR LLC Filed SCHEDULE 13G/A on Harmony Biosciences Holdings, Inc., latest Feb 5, 2026 (5 filings since Feb 9, 2022)
  • Valor IV Pharma Holdings, LLC Filed SCHEDULE 13G/A on Harmony Biosciences Holdings, Inc., latest Nov 14, 2025 (5 filings since Feb 10, 2022)
  • Marshman Fund Trust II Filed SCHEDULE 13G/A on Harmony Biosciences Holdings, Inc., latest Feb 10, 2025
  • HBM Healthcare Investments (Cayman) Ltd. Filed SC 13G/A on Harmony Biosciences Holdings, Inc., latest Feb 14, 2023 (2 filings since Feb 11, 2022)
  • Vivo Capital VIII, LLC Filed SC 13G/A on Harmony Biosciences Holdings, Inc., latest Feb 14, 2023 (2 filings since Feb 11, 2022)
  • venBio Global Strategic Fund II L.P. Filed SC 13G/A on Harmony Biosciences Holdings, Inc., latest Feb 14, 2022
  • Harmony Biosciences Holdings, Inc. Plymouth Meeting, Pennsylvania
    • Zynerba Pharmaceuticals Stake · Easttown Township, Pennsylvania, United States
    • Epygenix Therapeutics, Inc. Subsidiary · Wyoming, United States
    • Harmony Biosciences Management, Inc. Subsidiary · Delaware, United States
    • Harmony Biosciences, LLC Subsidiary · Delaware, United States
    • Zynerba Pharmaceuticals Pty Ltd Subsidiary · Australia

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What Harmony Biosciences Holdings, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$1.3M9 Dec 31, 2024$371.0K9 Dec 31, 2023+238.8%
Operating-lease assets (leased space)$5.3M5 Dec 31, 2025$2.1M5 Dec 31, 2024+151.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$752.5M5 Dec 31, 2025$453.0M5 Dec 31, 2024+66.1%
Marketable securities, current$22.8M5 Dec 31, 2025$14.2M5 Dec 31, 2024+61.0%
Long-term investments$107.1M5 Dec 31, 2025$108.9M5 Dec 31, 2024−1.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$89.4M5 Dec 31, 2025$113.3M5 Dec 31, 2024−21.1%
Accumulated amortization$125.6M5 Dec 31, 2025$101.7M5 Dec 31, 2024+23.4%
Finite-lived intangibles, net$89.4M5 Dec 31, 2025$113.3M9 Dec 31, 2024−21.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.4M5 Dec 31, 2025$7.2M5 Dec 31, 2024−25.6%
Raw materials$944.0K5 Dec 31, 2024$1.1M9 Dec 31, 2023−10.9%
Work in process$2.9M5 Dec 31, 2025$3.5M5 Dec 31, 2024−17.3%
Finished goods$2.6M5 Dec 31, 2025$2.8M5 Dec 31, 2024−4.7%

Properties, in its own words

We do not own any real property. Our corporate headquarters, located in Plymouth Meeting, Pennsylvania, has a footprint of approximately 35,781 square feet of space pursuant to a lease that expires in 2031. We believe that our facilities are suitable to meet our current needs.

Item 2 of the 10-K filed Feb 24, 2026.4

Leadership

Who has led Harmony Biosciences Holdings, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (21)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Oct 13, 20268-K Executive or director change; Regulation FD disclosure37
  2. Aug 4, 20268-K Results of operations; Regulation FD disclosure38
  3. Jul 16, 20268-K Results of operations; Executive or director change; Regulation FD disclosure39
  4. May 14, 20268-K Shareholder vote40
  5. May 7, 20268-K Results of operations; Regulation FD disclosure41
  6. Apr 14, 20268-K Executive or director change; Regulation FD disclosure42
  7. Apr 2, 20268-K Executive or director change; Regulation FD disclosure43
  8. Feb 24, 20268-K Results of operations; Regulation FD disclosure44
  9. Jan 12, 20268-K Results of operations; Regulation FD disclosure45
  10. Nov 4, 20258-K Results of operations; Regulation FD disclosure46
  11. Oct 23, 20258-K Results of operations47
  12. Sep 24, 20258-K Regulation FD disclosure48
  13. May 30, 2023New chief executive Jeffrey M. Dayno becomes CEO13
  14. Aug 18, 2020New chief executive John C. Jacobs becomes CEO14

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.87 a share, on Nov 4, 2025.49

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results38
  2. Jul 16, 2026Reported quarterly or annual results39
  3. May 7, 2026Reported quarterly or annual results41
  4. Feb 24, 2026Reported quarterly or annual results44
  5. Jan 12, 2026Reported quarterly or annual results45
  6. Nov 4, 2025Reported quarterly or annual results46
  7. Oct 23, 2025Reported quarterly or annual results47
  8. Aug 5, 2025Reported quarterly or annual results50

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

349 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 63 major events, 157 insider forms, 28 large holders, 80 other. The latest 20:

  1. Oct 13, 20268-K EDGAR
  2. Sep 18, 20264 EDGAR
  3. Sep 18, 2026144 EDGAR
  4. Sep 17, 2026144 EDGAR
  5. Sep 16, 2026144 EDGAR
  6. Sep 9, 20264 EDGAR
  7. Sep 8, 2026144 EDGAR
  8. Sep 4, 2026144 EDGAR
  9. Aug 7, 2026144 EDGAR
  10. Aug 4, 202610-Q EDGAR
  11. Aug 4, 20268-K EDGAR
  12. Jul 31, 2026SCHEDULE 13G EDGAR
  13. Jul 28, 2026SCHEDULE 13G/A EDGAR
  14. Jul 22, 20263 EDGAR
  15. Jul 16, 20268-K EDGAR
  16. Jul 2, 2026144 EDGAR
  17. Jun 30, 2026144 EDGAR
  18. Jun 26, 2026144 EDGAR
  19. Jun 24, 2026144 EDGAR
  20. Jun 9, 2026144 EDGAR

The 349 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

136 open-market trades by officers, directors and large owners since October 2021: 0 buys and 136 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 18, 2026Budur KumarCHIEF MEDICAL OFFICERSale35,852$43.05$1.5MForm 4
Sep 17, 2026Budur KumarCHIEF MEDICAL OFFICERSale800$43.00$34.4KForm 4
Sep 16, 2026Budur KumarCHIEF MEDICAL OFFICERSale1,800$43.01$77.4KForm 4
Sep 8, 2026Budur KumarCHIEF MEDICAL OFFICERSale28,454$42.95$1.2MForm 4
Sep 4, 2026Budur KumarCHIEF MEDICAL OFFICERSale5,500$41.98$230.9KForm 4
Jan 26, 2026Kapadia SandipCHIEF FINANCIAL OFFICERSale3,746$37.15$139.2KForm 4
Jan 15, 2026Kapadia SandipCHIEF FINANCIAL OFFICERSale20,961$35.92$752.9KForm 4
Dec 12, 2025Dayno Jeffrey M.PRESIDENT, CEOSale25,933$40.11$1.0MForm 4
Dec 5, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale20,000$39.54$790.8KForm 4
Nov 21, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale3,427$35.00$119.9KForm 4
Aug 15, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale21,573$36.50$787.4KForm 4
Apr 1, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale6,987$32.55$227.4KForm 4
Mar 3, 2025Dierks JeffreyCHIEF COMMERCIAL OFFICERSale4,869$32.67$159.1KForm 4
Jan 27, 2025Dierks JeffreyCHIEF COMMERCIAL OFFICERSale1,629$38.02$61.9KForm 4
Jan 27, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale1,775$38.05$67.5KForm 4
Jan 24, 2025Dierks JeffreyCHIEF COMMERCIAL OFFICERSale13,125$37.30$489.6KForm 4
Jan 21, 2025Dayno Jeffrey M.PRESIDENT, CEOSale19,293$40.13$774.2KForm 4
Jan 21, 2025Kapadia SandipCHIEF FINANCIAL OFFICERSale25,000$40.18$1.0MForm 4
Jan 21, 2025Dierks JeffreyCHIEF COMMERCIAL OFFICERSale1,123$40.00$44.9KForm 4
Jan 16, 2025Dierks JeffreyCHIEF COMMERCIAL OFFICERSale29,475$37.41$1.1MForm 4

All 136 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Stakes it holds

Harmony Biosciences Holdings, Inc. has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Jeffrey M. DaynoM.D.68$743.6K$7.9M61
2025Adam Zaeske53$376.9K$3.7M61
2025Sandip Kapadia56$522.8K$3.2M61
2025Jeffrey Dierks$132.3K$2.3M61
2025Kumar Budur55$598.0K$2.3M61
2025Andrew Serafin51$439.2K$2.0M61
2024President and Chief$715.0K$7.1M61
2024EVP and Chief Medical & Scientific$555.1K$5.7M61
2024EVP and Chief Financial Officer and$507.6K$3.1M61
2024Former EVP and Chief Commercial$508.7K$2.5M61
2024EVPChief Strategy Officer$420.3K$2.1M61
2023Chief Administrative Officer$507.6K$5.6M61
2023Executive Officer$612.5K$4.5M61
2023Officer$440.3K$760.8K61
2023EVPChief Strategy Officer$402.2K$647.4K61

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.7,101,965$258.6M0.0%+31,930
Fmr LLC3,574,115$130.1M0.0%+416,476
Vanguard Portfolio Management LLC2,880,489$104.9M0.0%+166,136
American Century Companies Inc2,539,512$92.5M0.0%+434,333
Dimensional Fund Advisors LP2,393,588$87.1M0.0%+317,078
Vanguard Capital Management LLC2,105,053$76.6M0.0%+2,738
State Street Corp1,859,322$67.7M0.0%+74,960
Armistice Capital, LLC1,564,000$56.9M1.6%−60,000
Geode Capital Management, LLC1,442,649$52.5M0.0%+119,929
Arrowstreet Capital, Limited Partnership1,312,550$47.8M0.0%−69,563
Renaissance Technologies LLC1,195,371$43.5M0.1%+118,000
Two Sigma Investments, LP959,136$34.9M0.0%+225,693
Aqr Capital Management LLC934,326$34.0M0.0%+218,080
Valor Management LLC818,013$29.8M0.0%+700,883
Morgan Stanley733,684$26.7M0.0%−297,334
UBS Group AG602,990$22.0M0.0%+154,999
DZ BANK AG Deutsche Zentral Genossenschafts Bank, Frankfurt am Main551,075$20.1M0.0%−16,040
Invesco Ltd.528,520$19.2M0.0%−99,727
Jpmorgan Chase & Co514,085$18.2M0.0%−309,428
venBio Partners LLC472,194$17.2M3.3%−17,000
Northern Trust Corp471,221$17.2M0.0%+47,992
Bnp Paribas Financial Markets438,302$16.0M0.0%−106,886
Charles Schwab Investment Management Inc423,824$15.4M0.0%+12,227
Nomura Holdings Inc417,932$15.2M0.1%−103,015
Goldman Sachs Group Inc403,532$14.7M0.0%−835,675

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Harmony Biosciences Holdings, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARHarmony Biosciences Holdings, Inc.1
  • CIK0001802665
  • Employer ID (EIN)82-22799234
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address630 W Germantown Pike, Suite 215, Plymouth Meeting, PA 194621
  • Phone(484) 539-98001
  • Shares outstanding58,236,393 as of Jul 31, 202611
  • Public float$1.3B as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, Philadelphia, PA PCAOB ID 34; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceFeb 14, 20201
  • Filings456 in all: 4 (182), 8-K (73), 144 (43), 3 (24), SC 13G/A (20), 10-Q (18), SCHEDULE 13G/A (10), SC 13G (9)1
    All 37 form types

    10-K (6), CORRESP (6), DEF 14A (6), DEFA14A (6), 4/A (5), 8-K/A (5), S-8 (5), UPLOAD (5), ARS (4), SC TO-T/A (4), S-1/A (3), 3/A (2), 424B7 (2), S-3ASR (2), SC TO-C (2), 10-K/A (1), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), EFFECT (1), S-1 (1), S-1MEF (1), SC 13D (1), SC TO-T (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 3, 2026
    Latest 8-K (8-K) Oct 13, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.00001 value per shareHRMYNasdaq

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Harmony Biosciences Holdings, Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 67 risks under these headings, as written.4

  • Risks Related to Our Business
  • We are substantially dependent on the commercial success of our only approved product, WAKIX. If we are unable to maintain or increase sales of WAKIX, our ability to generate revenue and our financial condition will be adversely affected.
  • The continued commercial success of WAKIX and any other product candidates we develop will depend on the degree of their market acceptance.
  • The market opportunity for WAKIX or any future product candidate we develop may be smaller than we estimate.
  • We rely on our license agreements with Bioprojet to provide rights to the core intellectual property relating to pitolisant, and any termination or loss of significant rights under the agreement would adversely affect our development and/or commercialization of pitolisant.
  • We may not be successful in our efforts to identify other indications for pitolisant beyond EDS and/or cataplexy in adults and pediatric patients six years and older or, in-license, acquire, discover, develop or commercialize additional product candidates or on-market products.
  • Our business, products or product pricing could be subject to negative publicity, which could have a material adverse effect on our reputation, business, financial position, results of operations, liquidity and cash flows.
  • Third-party relationships are important to our business. If we are unable to enter into and maintain strategic collaborations or if these relationships are not successful, our business could be adversely affected.
  • We continue to rely on third parties to conduct our clinical trials for pitolisant and other product candidates that we decide to develop. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates on a timely basis or at all.
  • We rely completely on third parties to manufacture and distribute our supply of WAKIX and our product candidates, including certain sole-source suppliers and manufacturers, and intend to rely on third parties to manufacture and distribute any future product candidates.
  • Because a number of companies compete with us, many of which have greater resources than we do, and because we face rapid changes in science in our industry, we cannot be certain that our products will be accepted in the marketplace or capture market share.
  • We may need to increase the size and capabilities of our organization based on business need, and we may experience difficulties in managing our growth.
The other 56 risks
  • Our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
  • Public health pandemics, such as the COVID-19 pandemic, may result in disruptions to our commercialization, clinical trials, manufacturing and other business operations, which could have a material adverse effect on our business, financial condition, operating results, cash flows and prospects.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • We depend on our information technology systems, and any failure of these systems could harm our business. Any real or perceived security breaches, loss of data, and other disruptions or incidents could compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • A variety of risks associated with operating internationally could materially adversely affect our business.
  • Failure to keep up with evolving laws, regulations, trends and shareholder expectations relating to environmental, social and governance, or ESG, practices or reporting could adversely impact our reputation, share price and access to and cost of capital or otherwise adversely impact our business.
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have made and may be required in the future to make significant payments to Bioprojet under our licensing and collaboration agreements for pitolisant.
  • Our TLA Credit Agreement contains restrictive and financial covenants that may limit our operating flexibility.
  • Our failure to comply with the covenants or other terms of the TLA Credit Agreement, including as a result of events beyond our control, could result in a default under the TLA Credit Agreement that could materially and adversely affect the ongoing viability of our business.
  • We have never paid dividends on our common stock, and we do not intend to pay dividends for the foreseeable future. Consequently, any gains from an investment in our common stock will likely depend on whether the price of our common stock increases.
  • Raising additional funds by issuing securities may cause dilution to existing shareholders, raising additional funds through debt financings may involve restrictive covenants, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights to our technologies or product candidates.
  • Our ability to utilize our net operating loss carryforwards may be limited.
  • Changes in tax laws or regulations could adversely affect our results of operations, business and financial condition.
  • Risks Related to Development, Regulatory Approval and Commercialization
  • The regulatory approval process of the FDA is costly, lengthy and inherently unpredictable, and our business may be substantially harmed if we experience insufficient results in the course of our clinical development or are ultimately unable to obtain regulatory approval for any of our ongoing development programs in other potential indications.
  • If we fail to obtain and sustain an adequate level of coverage and reimbursement for WAKIX and other product candidates by third-party payors, sales would be adversely affected.
  • WAKIX or any of our future product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, reduce the commercial attractiveness of a prescribing label or result in significant negative consequences following regulatory approval, if approved.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.
  • We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • A Fast Track designation from the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval.
  • Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • Even if we receive orphan drug designation for our product candidates, we may not be able to maintain the benefits associated with orphan drug designation, including marketing exclusivity, which may cause our product revenue to be reduced.
  • We are subject to ongoing regulatory obligations and continued regulatory review with respect to WAKIX, which will result in significant additional expense. Additionally, WAKIX could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with WAKIX.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers are subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Actual or perceived failure to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • Clinical practice guidelines and recommendations published by various organizations could have significant influence on the use of WAKIX.
  • Product candidates we develop in the future may be classified as controlled substances, the making, use, sale, importation, exportation and distribution of which are subject to regulation by state, federal and foreign law enforcement and other regulatory agencies.
  • Enacted and future healthcare legislative changes may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and affect the prices we may obtain.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs that we participate in, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and antimony laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We have obtained a rare pediatric disease designation for EPX100 for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome, however, there is no guarantee that FDA approval of will result in issuance of a priority review voucher.
  • We will need to obtain FDA approval of any proposed product names, and any failure or delay associated with such approval may adversely affect our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our current and future product candidates.
  • If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent term for our current and future product candidates, our business may be harmed.
  • The validity, scope and enforceability of any patents listed in the Orange Book that cover our current and future product candidates have been challenged by third parties and may be challenged by third parties in the future.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may need to acquire or license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate patents or other proprietary rights, may delay or prevent the development and commercialization of any of our current or future product candidates.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Any trademarks we have obtained or may obtain may be infringed or be successfully challenged, resulting in harm to our business.
  • Risks Related to Ownership of our Common Stock
  • Our directors, officers and principal stockholders beneficially own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.
  • Future sales of our common stock in the public market, including sales by our directors, officers, or significant shareholders, could cause our share price to fall.
  • If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.
  • Our quarterly operating results may fluctuate significantly.
  • Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.
  • Our charter documents and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock.
  • Our Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

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.

Refer to Part II, Item 8, Note 13 “Commitments and Contingencies,” of this Annual Report for a full description of our material pending legal matters.

The opening of Item 3, Legal Proceedings.4

Sources

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