AVDL on NASDAQ

Avadel Pharmaceuticals

Logo: Avadel Pharmaceuticals, Public domain, via Wikimedia Commons4

Specialty pharmaceutical company

Avadel Pharmaceuticals plc was an Irish specialty pharmaceutical company focused on sleep disorder medicines marketed for hospital and primary care treatments. Headquartered in Dublin, Ireland, it had operations in St. Louis, Missouri and Lyon, France. It was a developer of the US FDA-approved anti-narcolepsy medication LUMRYZ (sodium oxybate).3 Its shares trade on NASDAQ under the symbol AVDL.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

1990Founded1

Compare with Syndax Pharmaceuticals Inc, Phathom Pharmaceuticals, Inc. or Cryoport, Inc., or pick any stock.

  • TickerAVDL on NASDAQ1
  • IndustryPharmaceutical Preparations1
  • HeadquartersLyon1
  • Websitewww.avadel.com
  • Business address10 Earlsfort Terrace, Dublin 2, D02 T3805
  • Filer categoryLarge accelerated filer5

Avadel Pharmaceuticals plc was an Irish specialty pharmaceutical company focused on sleep disorder medicines marketed for hospital and primary care treatments. Headquartered in Dublin, Ireland, it had operations in St. Louis, Missouri and Lyon, France. It was a developer of the US FDA-approved anti-narcolepsy medication LUMRYZ (sodium oxybate). It was acquired by Alkermes in February 2026.3

Financials

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

Key numbers, fiscal 2024

91.0%Gross margin8
-25.1%Operating margin8
-28.9%Net margin8
504.8%Revenue growth, 20248
-66.1%Return on equity8
-$46.9MFree cash flow8

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Cost of revenue7¢$15.3M
  • Research and development7¢$15.2M
  • Selling, general and admin85¢$181.0M
  • Income tax0¢$247.0K

Out of $169.1M in revenue.8 The company lost money this year.

Financial statements

Revenue910118$169.1M in 2024+64% since 2018
0$50.0M$100.0M$150.0M$200.0M2018: $103.3M$103.3M20182019: $59.2M$59.2M2019−43%2020: $22.3M$22.3M2020−62%2021: $0$020212022: $0$020222023: $28.0M$28.0M20232024: $169.1M$169.1M2024+505%
Gross profit118$153.8M in 2024
0$50.0M$100.0M$150.0M$200.0M2021: $0$020212022: $0$020222023: $27.1M$27.1M20232024: $153.8M$153.8M2024+467%
Operating income910118-$42.4M in 2024−60% since 2018
-$150.0M-$100.0M-$50.0M0$50.0M2018: -$104.9M-$104.9M20182019: -$24.1M-$24.1M2019−77%2020: $5.8M$5.8M20202021: -$85.5M-$85.5M20212022: -$98.6M-$98.6M2022+15%2023: -$137.8M-$137.8M2023+40%2024: -$42.4M-$42.4M2024−69%
Net income910118-$48.8M in 2024−49% since 2018
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2018: -$95.3M-$95.3M20182019: -$33.2M-$33.2M2019−65%2020: $7.0M$7.0M20202021: -$77.3M-$77.3M20212022: -$137.5M-$137.5M2022+78%2023: -$160.3M-$160.3M2023+17%2024: -$48.8M-$48.8M2024−70%
Fiscal year2018201920202021202220232024
Revenue$103.3M9$59.2M10$22.3M10$011$08$28.0M8$169.1M8
Cost of revenue$17.5M9$12.1M10$5.7M10$011$08$846.0K8$15.3M8
Gross profit$011$08$27.1M8$153.8M8
Research and development$39.3M9$32.9M10$20.4M10$17.1M11$20.7M8$13.3M8$15.2M8
Selling, general and admin$100.4M9$30.2M10$32.4M10$68.5M11$74.5M8$151.7M8$181.0M8
Operating expenses$85.5M11$98.6M8$165.0M8$196.2M8
Operating income-$104.9M9-$24.1M10$5.8M10-$85.5M11-$98.6M8-$137.8M8-$42.4M8
Interest$12.5M10$13.0M10$9.9M14$12.3M14
Income before tax-$93.1M11-$111.4M8-$160.8M8-$49.1M8
Income tax-$17.9M9-$5.4M10-$12.1M10-$15.8M11$26.0M8-$501.0K8-$247.0K8
Net income-$95.3M9-$33.2M10$7.0M10-$77.3M11-$137.5M8-$160.3M8-$48.8M8
Earnings per share-$2.559-$0.8910$0.1310-$1.3211-$2.298-$2.008-$0.518
Earnings per share (diluted)-$2.559-$0.8910$0.1310-$1.3211-$2.298-$2.008-$0.518
Shares (weighted, basic)58.5M shares1160.1M shares880.2M shares895.1M shares8
Shares (weighted, diluted)58.5M shares1160.1M shares880.2M shares895.1M shares8

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Corporate structure

Avadel Pharmaceuticals is part of a group headed by Alkermes. 10 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Avadel Pharmaceuticals

  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Avadel Pharmaceuticals, latest Feb 17, 2026 (8 filings since Aug 10, 2023)
  • Two Seas Capital LP Filed SCHEDULE 13G/A on Avadel Pharmaceuticals, latest Feb 17, 2026 (3 filings since May 15, 2025)
  • BRANDES INVESTMENT PARTNERS, LP Filed SCHEDULE 13G/A on Avadel Pharmaceuticals, latest Feb 12, 2026 (3 filings since Feb 8, 2022)
  • Jeffrey L. Gendell Filed SCHEDULE 13G/A on Avadel Pharmaceuticals, latest Feb 6, 2026 (4 filings since Jun 3, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G on Avadel Pharmaceuticals, latest Jul 29, 2025 (2 filings since Jul 29, 2025)
  • BlackRock Filed SCHEDULE 13G/A on Avadel Pharmaceuticals, latest Jul 16, 2025 (3 filings since Oct 24, 2024)
  • RTW INVESTMENTS, LP Filed SC 13G/A on Avadel Pharmaceuticals, latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • COWEN AND COMPANY, LLC Filed SC 13G/A on Avadel Pharmaceuticals, latest Nov 13, 2024 (3 filings since Nov 12, 2021)
  • Polar Capital Holdings Plc Filed SC 13G/A on Avadel Pharmaceuticals, latest Nov 13, 2024 (3 filings since Feb 14, 2022)
  • Kevin Kotler Filed SC 13G/A on Avadel Pharmaceuticals, latest Feb 12, 2024 (4 filings since Jun 6, 2022)
  • Vivo Opportunity, LLC Filed SC 13G/A on Avadel Pharmaceuticals, latest Feb 14, 2023 (2 filings since Feb 11, 2022)
  • Avoro Capital Advisors LLC Filed SC 13G/A on Avadel Pharmaceuticals, latest Feb 11, 2022
  • Alkermes Waltham, Massachusetts, United States
    • Avadel Pharmaceuticals Lyon
      • 2) Flamel Ireland Ltd. (d/b/a Avadel Ireland) Subsidiary · Ireland
      • 3) Avadel Investment Company, Ltd. Subsidiary · Cayman Islands
      • 4) Avadel France Holding SAS Subsidiary · France
      • 5) Avadel Finance Ireland Designated Activity Company Subsidiary · Ireland
      • A. Avadel Finance Cayman Ltd. Subsidiary · Cayman Islands
      • A. Avadel Research SAS Subsidiary · France
      • Avadel Pharmaceuticals plc (the Registrant) Subsidiary · Ireland
    • Alkermes (United States) Subsidiary · United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; subsidiaries, stakes and holdings from Wikidata (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Avadel Pharmaceuticals 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
Accumulated depreciation$1.0M8 Dec 31, 2024$881.0K8 Dec 31, 2023+15.0%
Property and equipment, net$453.0K8 Dec 31, 2024$585.0K8 Dec 31, 2023−22.6%
Operating-lease assets (leased space)$1.7M8 Dec 31, 2024$2.6M8 Dec 31, 2023−34.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$51.4M8 Dec 31, 2024$31.2M8 Dec 31, 2023+64.8%
Marketable securities, current$22.4M8 Dec 31, 2024$73.9M8 Dec 31, 2023−69.7%
Debt securities available for sale$22.4M8 Dec 31, 2024$73.9M8 Dec 31, 2023−69.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$16.8M8 Dec 31, 2024$16.8M8 Dec 31, 20230%

Inventory

ItemLatestA year beforeChange
Inventory, total$20.3M8 Dec 31, 2024$10.4M8 Dec 31, 2023+95.5%
Work in process$5.0M8 Dec 31, 2024$2.0M8 Dec 31, 2023+143.6%
Finished goods$10.1M8 Dec 31, 2024$3.1M8 Dec 31, 2023+232.1%

Properties, in its own words

We have commercial and administrative activities located in Chesterfield, Missouri. In January 2025, our lease expired which consisted of 24,236 square feet of office space. Effective February 2025, we decreased our office space to consist of 17,065 square feet, and the amended lease expires in January 2029.

See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of this Annual Report on Form 10-K for more information regarding our investment activities and principal capital expenditures over the last two years.

Item 2 of the 10-K filed Mar 3, 2025.16

The story

Founded as Flamel Technologies SA in Lyon, France, in 1990, the company acquired FSC Holdings and its pediatric, therapeutics, and laboratory subsidiaries in 2016. in January 2017, Flamel, Éclat, and FCS Pediatrics became Avadel Pharmaceuticals following a cross-border merger from France to Ireland.

When Craig Stapleton resigned as chairman in 2019, COO Gregory Divis temporarily assumed the role of CEO after Mike Anderson resigned; that same year, Avadel filed for Chapter 11 bankruptcy. In 2023, a year after acquiring Éclat Pharmaceuticals, it received FDA approval for Lumryz, a prolonged-release oral suspension of sodium oxybate.

In 2025, a bidding war ensued between Irish Alkermes plc and Danish Lundbeck over the acquisition of Avadel. In October, Alkerms made an offer for up to $2.1 billion, which included $18.50 per share in cash plus $1.50 per share contingent on expanded approval of Lumryz by the end of 2028.

Lundbeck then offered a competing bid with the same cash per share amount but with up to $2 per share tied to future sales milestones for Lumryz and valiloxybate, an experimental therapy. Alkermes then revised their offer to $21 per share in cash and the contingent $1.50 per share.

When Alkermes' revised $2.37 billion offer was accepted by the drugmaker's board in November, the deal was expected to close in the first quarter of 2026. On February 12, 2026, it was announced that Alkermes had completed the acquisition of Avadel, after which Avadel was delisted.

From Wikipedia’s article on Avadel Pharmaceuticals, shared under CC BY-SA 4.0.6

Leadership

Who has led Avadel Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.

Chief operating officer

  1. Susan Rodriguez2025–now
1995200020052010201520202025
Board members and other officers (29)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • 2) Flamel Ireland Ltd. (d/b/a Avadel Ireland) Ireland7
  • 3) Avadel Investment Company, Ltd. Cayman Islands7
  • 4) Avadel France Holding SAS France7
  • 5) Avadel Finance Ireland Designated Activity Company Ireland7
  • A. Avadel Finance Cayman Ltd. Cayman Islands7
  • A. Avadel Research SAS France7
  • Avadel Pharmaceuticals plc (the Registrant) Ireland7

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

Former names

  • FLAMEL TECHNOLOGIES SAFeb 25, 1997 to Dec 30, 20165

Timeline

  1. Feb 12, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer50
  2. Jan 20, 20268-K Other events51
  3. Jan 12, 20268-K Shareholder vote; Other events52
  4. Dec 18, 20258-K Regulation FD disclosure; Other events53
  5. Dec 9, 20258-K Other events54
  6. Nov 19, 20258-K Entered a material agreement; Regulation FD disclosure55
  7. Nov 17, 20258-K Other events56
  8. Nov 14, 20258-K Other events57
  9. Nov 4, 20258-K Results of operations58
  10. Oct 22, 20258-K Entered a material agreement; Regulation FD disclosure59
  11. Oct 22, 20258-K Entered a material agreement; Regulation FD disclosure60
  12. Sep 17, 20258-K Other events61
  13. Jun 3, 2019New chief executive Greg J. Divis becomes CEO17
  14. Jun 29, 1998Went public Listed on NASDAQ1
  15. 1990Founded Founded1

Calendar

When it reported results

  1. Nov 4, 2025Reported quarterly or annual results58
  2. Aug 7, 2025Reported quarterly or annual results62
  3. May 7, 2025Reported quarterly or annual results63
  4. Mar 3, 2025Reported quarterly or annual results64
  5. Jan 8, 2025Reported quarterly or annual results65
  6. Nov 12, 2024Reported quarterly or annual results66
  7. Aug 8, 2024Reported quarterly or annual results67
  8. May 8, 2024Reported quarterly or annual results68

Drug trials and FDA: recently

  1. Mar 25, 2026Phase 3 trial completed Phase 3 trial of FT218 in Idiopathic Hypersomnia: primary completion Mar 25, 2026, no results posted yet (ClinicalTrials.gov NCT06525077).69

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

295 filings to the SEC since October 2021: 5 annual reports, 13 quarterly reports, 82 major events, 92 insider forms, 40 large holders, 63 other. The latest 20:

  1. Feb 23, 202615-12G EDGAR
  2. Feb 18, 20264 PRIMARY DOCUMENT EDGAR
  3. Feb 18, 20263 PRIMARY DOCUMENT EDGAR
  4. Feb 17, 2026SCHEDULE 13G/A EDGAR
  5. Feb 17, 2026SCHEDULE 13G/A EDGAR
  6. Feb 13, 2026EFFECT EDGAR
  7. Feb 13, 2026EFFECT EDGAR
  8. Feb 13, 2026EFFECT EDGAR
  9. Feb 13, 2026EFFECT EDGAR
  10. Feb 12, 202625-NSE EDGAR
  11. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  15. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Feb 12, 20264 OWNERSHIP DOCUMENT EDGAR

The 295 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

30 open-market trades by officers, directors and large owners since October 2021: 27 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 13, 2026WEISS ANDREW MSale11,112,052$21.00$233.4MForm 4
Jan 21, 2025Palczuk LindaDirectorBuy5,000$7.93$39.6KForm 4
Jan 13, 2025Thornton Peter J.DirectorBuy10,000$8.05$80.5KForm 4
Jan 13, 2025Ende Eric JDirectorBuy30,000$7.84$235.2KForm 4
Dec 13, 2024MCHUGH THOMAS SChief Financial OfficerBuy2,300$10.44$24.0KForm 4
Dec 11, 2024MCHUGH THOMAS SChief Financial OfficerBuy5,000$10.49$52.5KForm 4
Dec 10, 2024Glass Geoffrey MichaelDirectorBuy20,279$9.84$199.6KForm 4
Dec 9, 2024Divis Gregory JChief Executive OfficerBuy402$9.82$3.9KForm 4
Dec 6, 2024Divis Gregory JChief Executive OfficerBuy9,598$9.98$95.8KForm 4
Dec 6, 2024Palczuk LindaDirectorBuy3,000$10.19$30.6KForm 4
Jan 16, 2024MCHUGH THOMAS SChief Financial OfficerBuy2,000$14.50$29.0KForm 4
Dec 28, 2023McCamish Mark AnthonyDirectorSale75,000$14.53$1.1MForm 4
Aug 14, 2023MCHUGH THOMAS SChief Financial OfficerBuy2,000$14.45$28.9KForm 4
Aug 11, 2023McCamish Mark AnthonyDirectorSale28,975$14.93$432.6KForm 4
Aug 10, 2023Glass Geoffrey MichaelDirectorBuy14,000$13.40$187.6KForm 4
Aug 10, 2023Divis Gregory JChief Executive OfficerBuy10,000$13.20$132.0KForm 4
May 18, 2023Ende Eric JDirectorBuy13,000$13.93$181.1KForm 4
May 9, 2023Palczuk LindaDirectorBuy2,500$14.76$36.9KForm 4
Dec 23, 2022Palczuk LindaDirectorBuy2,000$7.20$14.4KForm 4
Nov 29, 2022MCHUGH THOMAS SChief Financial OfficerBuy5,000$7.80$39.0KForm 4

All 30 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.

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
2024Gregory J. DivisChief Executive Officer58$651.6K$7.4M82
2024Richard J. KimFormer Chief Commercial Officer$472.3K$2.8M82
2024Thomas S. McHughChief Financial Officer60$465.4K$2.3M82
2024Jerad G. Seurer General Counsel & Corporate Secretary52$420.0K$2.0M82
2023Gregory J. DivisChief Executive Officer58$600.0K$985.2K82
2023Richard J. KimFormer Chief Commercial Officer$454.2K$771.0K82
2023Thomas S. McHughChief Financial Officer60$438.0K$663.1K82
2022Gregory J. DivisChief Executive Officer58$561.1K$753.7K82
2022Richard J. KimFormer Chief Commercial Officer$437.8K$548.4K82
2022Thomas S. McHughChief Financial Officer60$420.3K$526.0K82

SEC filer profile

How Avadel Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAVADEL PHARMACEUTICALS PLC2
  • CIK0001012477
  • Employer ID (EIN)98-134193316
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company16
  • Incorporated inIreland16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland2
  • Mailing address16640 Chesterfield Grove Road, Suite 200, Chesterfield, MO 630052
  • Phone636-449-18302
  • Shares outstanding97,656,664 as of Oct 31, 202513
  • Public float$1.3B as of Jun 28, 202416
  • AuditorDeloitte & Touche LLP, St. Louis, Missouri PCAOB ID 34; it also attests to the company’s internal control over financial reporting16
  • On EDGAR sinceFeb 14, 19972
  • Filings1,174 in all: 4 (267), 8-K (221), 6-K (151), SC 13G/A (84), 3 (51), 4/A (41), SC 13G (41), 10-Q (30)2
    All 54 form types

    SC 13D/A (30), CORRESP (26), DEFA14A (25), UPLOAD (23), S-8 POS (16), 20-F (14), EFFECT (12), S-8 (12), 10-K (10), DEF 14A (10), SCHEDULE 13G/A (10), 424B5 (8), 8-K/A (8), CT ORDER (8), DEFR14A (6), POS AM (6), 20-F/A (5), SC 13D (5), PRE 14A (4), SCHEDULE 13G (4), 10-K/A (3), 6-K/A (3), ARS (3), F-3 (3), F-3/A (3), S-3 (3), 144 (2), 15-12G (2), 25-NSE (2), 424B3 (2), 424B4 (2), NT 10-K (2), NT 10-Q (2), PX14A6G (2), 10-Q/A (1), 25-NSE/A (1), 8-A12B (1), 8-K12B (1), 8-K12B/A (1), DEFM14A (1), F-6 (1), F-6EF (1), POSASR (1), PREM14A (1), PRER14A (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 3, 2025
    Quarterly report (10-Q) Nov 4, 2025
    Proxy statement (DEF 14A) Jun 18, 2025
    Latest 8-K (8-K) Feb 12, 2026

Securities registered for trading

ClassSymbolExchange
Ordinary Shares, nominal value $0.01 per shareAVDLThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 3, 2025 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Avadel Pharmaceuticals names in Item 1A of its 10-K filed Mar 3, 2025: 70 risks under these headings, as written.16

  • Risks Related to the Commercialization of Our Lead Product
  • Our business depends heavily on our ability to successfully commercialize LUMRYZ in the U.S. and in other jurisdictions where we may obtain marketing approval. There is no assurance that our commercialization efforts with respect to LUMRYZ will be successful or that we will be able to generate revenues at the levels or on the timing we expect, or at levels or on the timing necessary to support our goals.
  • If we are unable to establish effective sales, marketing and distribution capabilities for LUMRYZ or enter into agreements with third parties to market, sell and distribute LUMRYZ, or if we are unable to achieve market acceptance for LUMRYZ, our business, results of operations, financial condition and prospects will be materially adversely affected.
  • LUMRYZ may not gain market acceptance.
  • LUMRYZ is subject to ongoing enforcement of post-marketing requirements, and we could be subject to substantial penalties, including withdrawal of LUMRYZ from the market, if we fail to comply with all regulatory requirements. In addition, the terms of the marketing approval of LUMRYZ and ongoing regulation of our product may limit how we manufacture and market LUMRYZ, and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.
  • If our competitors develop and market technologies or products that are safer, more effective or less costly than ours, or obtain regulatory approval and market such products before we do, our commercial opportunity may be diminished or eliminated.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with LUMRYZ or any future product candidates, the sales of LUMRYZ and any future product candidates, if approved, could be adversely affected.
  • With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms for testing in support of their ANDAs and 505(b)(2) applications.
  • If we cannot keep pace with the rapid technological change in our industry, we may lose business, and LUMRYZ, our technologies or any future products could become obsolete or noncompetitive.
  • Our relationships with healthcare providers, physicians, prescribers, purchasers, third-party payors, charitable organizations and patients will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for LUMRYZ or any future products, if approved, which could make it difficult for us to sell LUMRYZ or any future products profitably.
  • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
The other 59 risks
  • If we fail to comply with our reporting and payment obligations under U.S. governmental pricing programs, 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.
  • LUMRYZ may be found to cause undesirable side effects that limit the commercial profile or result in other significant negative consequences or delay or prevent further development or regulatory approval with respect to new indications, or cause regulatory authorities to require labeling statements, such as boxed warnings.
  • We may incur significant liability if governmental authorities allege or determine that we are engaging in commercial activities or promoting LUMRYZ in a way that violates applicable regulations.
  • Obtaining and maintaining regulatory approval of LUMRYZ in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of LUMRYZ in other jurisdictions.
  • Laws and regulations governing international operations we have and may expand in the future may preclude us from developing, manufacturing, and selling certain product candidates and products outside of the U.S. and require us to develop and implement costly compliance programs.
  • Governments outside of the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Failure to comply with domestic and international privacy and security laws could inhibit our ability to collect and process data globally, and could result in the imposition of significant civil and criminal penalties.
  • We may expend our limited resources to pursue a particular indication and fail to capitalize on indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Product Candidate Development
  • Clinical development of drugs is costly and time-consuming, and the outcomes are uncertain. A failure to prove that LUMRYZ or any future product candidates are safe and effective in clinical trials could materially and adversely affect our business, financial condition, results of operations and growth prospects.
  • We cannot be certain that a product candidate will receive marketing approval. Without marketing approval, we will not be able to commercialize a product candidate.
  • Our current and future product candidates may not reach the commercial market for a number of reasons.
  • Risks Related to Our Financial Position and Capital Requirements
  • We incurred a net loss in 2024 and may incur a net loss in 2025, and if we are not able to achieve profitability in the future, the value of our shares may fall.
  • We may require additional financing to successfully commercialize LUMRYZ and implement our operating plans, which may not be available on favorable terms or at all, and which may result in dilution of the equity interest of the holders of our ordinary shares.
  • Our ability to obtain additional financing may be limited by the terms of our financing arrangements and the provisions of Irish law.
  • Our net loss and use of cash in operating activities may limit our ability to fully pursue our business strategy.
  • Risks Related to Regulation
  • The distribution and sale of LUMRYZ are subject to significant regulatory restrictions, including the requirements of a REMS and safety reporting requirements, and these regulatory requirements subject us to risks and uncertainties, any of which could negatively impact sales of LUMRYZ.
  • Disruptions at the FDA, the DEA 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, prevent new products and services from being developed or commercialized in a timely manner 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.
  • LUMRYZ may not maintain regulatory exclusivities, including orphan drug exclusivity, or the benefits of such exclusivities, which may adversely affect the sales of the product.
  • The API in LUMRYZ, sodium oxybate, is a controlled substance subject to U.S. federal and state controlled substance laws and regulations and applicable controlled substance legislation in other countries, and our failure, or the failure of third-parties on whom we rely, to comply with these laws and regulations, or the cost of compliance with these laws and regulations, could materially and adversely affect our business, results of operations, financial condition and growth prospects.
  • We are required to obtain regulatory approval of any proposed product names for our product candidates, and any failure or delay associated with such approval may adversely impact our business.
  • Risks Related to our Reliance on Third Parties
  • We rely, and intend to continue to rely on a limited number of suppliers for the development, manufacture and supply of LUMRYZ, and if we experience problems with these suppliers, or they fail to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, our business would be materially and adversely affected.
  • We contract with third parties for the manufacture of LUMRYZ for clinical testing and commercialization, and expect to continue to do so for any future products and product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities of LUMRYZ or any future products or product candidates, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We outsource important activities to consultants, advisors and outside contractors.
  • We depend on key personnel to execute our business plan. If we cannot attract and retain key personnel, we may not be able to successfully implement our business plan.
  • We have substantially increased our number of employees over the last year, and we expect to expand our organization as a result of the commercialization of LUMRYZ. As a result, we may experience difficulties in managing this growth, which could disrupt our operations.
  • We rely on third parties to conduct our clinical trials, and if they do not properly and successfully perform their contractual, legal and regulatory duties, we may not be able to obtain regulatory approvals for or commercialize any future product candidates.
  • We may rely on collaborations with third parties to commercialize LUMRYZ and any future products. Such strategy involves risks that could impair our prospects for realizing profits from such products.
  • Risks Related to Our Intellectual Property
  • If we cannot adequately protect our intellectual property and proprietary information, we may be unable to effectively compete.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
  • If we and our partners do not adequately protect the trademarks and trade names for our current and future products, then we and our partners may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Changes in U.S. or ex-U.S. patent laws could diminish the value of patents in general, thereby impairing our ability to protect current and future products.
  • Third parties may claim that our current or future product infringes their rights, and we may incur significant costs resolving these claims. Additionally, legal proceedings related to such claims could materially delay or otherwise adversely affect commercialization plans related to such product.
  • An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of any future product candidates.
  • If we or our partners are required to obtain licenses from third parties, our revenues and royalties on any future commercialized products could be reduced.
  • Patent terms may be inadequate to protect the competitive position of our product or any future products for an adequate amount of time.
  • 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 non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Our Business and Industry
  • Our business could be adversely affected by the effects of health epidemics, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of potential clinical trial sites or other business operations.
  • We are currently operating in a period of political and economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, ongoing military conflicts, including the conflict between Russia and Ukraine and the conflict in Israel, and high inflation and rising interest rates, any of which could have a material adverse effect on our business, financial condition and results of operations.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations
  • Risks Related to Litigation and Legal Matters
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We and companies to which we have licensed or will license any future products or technologies and subcontractors we engage or may engage for services related to the development and manufacturing of our product or any future product candidates are subject to extensive regulation by the FDA and other regulatory authorities. Our and their failure to meet strict regulatory requirements could adversely affect our business.
  • We may face product liability claims related to our product or future products, or claims related to clinical trials for any future product candidates.
  • If we use hazardous biological and/or chemical materials in a manner that causes injury, we may be liable for significant damages.
  • Risks Related to Ownership of Our Securities
  • The price of our ordinary shares has been volatile and may continue to be volatile.
  • If we pay dividends, the dividends may be subject to Irish dividend withholding tax.
  • General Risk Factors
  • Provisions of our articles of association could delay or prevent a third-party’s effort to acquire us.
  • Irish law differs from the laws in effect in the U.S. and might afford less protection to the holders of our ordinary shares and any actual or potential takeover offer for the Company will be subject to Irish Takeover Rules.
  • Judgments of U.S. courts, including those predicated on the civil liability provisions of the federal securities laws of the U.S., may not be enforceable in Irish courts.
  • Judgments of U.S. courts, including those predicated on the civil liability provisions of the federal securities laws of the U.S., may not be enforceable in Cayman Islands courts.
  • Security incidents and other disruptions could compromise confidential information, expose us to liability and cause our business and reputation to suffer.
  • We have broad discretion in the use of our cash and may not use it effectively.
  • We currently do not intend to pay dividends and cannot assure the holders of our ordinary shares that we will make dividend payments in the future.
  • Our effective tax rate could be highly volatile and could adversely affect our operating results.
  • Changes in tax law could adversely affect our business and financial condition.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • U.S. Holders of our ordinary shares may suffer adverse U.S. tax consequences if we are classified as a passive foreign investment company.
  • Certain U.S. Holders that own 10 percent or more of the vote or value of our ordinary shares may suffer adverse U.S. tax consequences because our non-U.S. subsidiaries are expected to be classified as controlled foreign corporations.

Legal proceedings

For information regarding legal proceedings we are involved in, see Note 13: Contingent Liabilities and Commitments to our audited consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.16

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