VNDA on Nasdaq

Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is an American pharmaceutical preparations company based in Washington.2 Its shares trade on Nasdaq under the symbol VNDA.2

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Last updated Oct 21, 2026.

Overview

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  • TickerVNDA on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWashington, United States2
  • Incorporated inDE3
  • Business address2200 Pennsylvania Ave Nw, Suite 300E, Washington, Dc 200373
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI529900AY8VOOQBKJ0O702
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 35907472

All forward-looking statements in this report are expressly qualified in their entirety by the cautionary statements contained throughout this report. We caution you not to rely too heavily on such forward-looking statements. Each forward-looking statement speaks only as of the date of this Annual Report, and we undertake no obligation, and specifically decline any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.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

-70.0%Operating margin5
-102.0%Net margin5
8.7%Revenue growth, 20255
-67.4%Return on equity5
-$110.4MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Fanapt brought in 54% of the revenue Vanda Pharmaceuticals Inc. broke down this way in fiscal 2025.

  1. Fanapt$117.3M554%up 24% from 2024
  2. Hetlioz$71.4M533%down 7% from 2024
  3. Ponvory$27.4M513%down 2% from 2024
Products and services by year
Products and services202320242025
Fanapt$90.9M$94.3M$117.3M
Hetlioz$100.2M$76.7M$71.4M
Ponvory$1.6M$27.8M$27.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development25¢$109.3M
  • Selling, general and admin55¢$238.0M
  • Income tax19¢$81.8M

Out of $216.1M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$216.1M in 2025−5% since 2019
0$100.0M$200.0M$300.0M2019: $227.2M$227.2M20192020: $248.2M$248.2M2020+9%2021: $268.7M$268.7M2021+8%2022: $254.4M$254.4M2022−5%2023: $192.6M$192.6M2023−24%2024: $198.8M$198.8M2024+3%2025: $216.1M$216.1M2025+9%
Operating income67895-$151.2M in 2025
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: $22.8M$22.8M20192020: $27.2M$27.2M2020+19%2021: $42.2M$42.2M2021+55%2022: $6.3M$6.3M2022−85%2023: -$14.0M-$14.0M20232024: -$40.7M-$40.7M2024+191%2025: -$151.2M-$151.2M2025+272%
Net income67895-$220.5M in 2025
-$300.0M-$200.0M-$100.0M0$100.0M$200.0M2019: $115.6M$115.6M20192020: $23.3M$23.3M2020−80%2021: $33.2M$33.2M2021+42%2022: $6.3M$6.3M2022−81%2023: $2.5M$2.5M2023−60%2024: -$18.9M-$18.9M20242025: -$220.5M-$220.5M2025+1067%

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 sales$216.1M$198.8M$192.6M
Total revenues$216.1M$198.8M$192.6M
Cost of goods sold excluding amortization$13.0M$11.3M$14.8M
Research and development$109.3M$74.4M$76.8M
Selling, general and administrative$238.0M$146.4M$112.9M
Intangible asset amortization$7.0M$7.3M$2.1M
Total operating expenses$367.3M$239.4M$206.6M
Loss from operations-$151.2M-$40.7M-$14.0M
Other income, net$12.5M$17.7M$20.3M
Income (loss) before income taxes-$138.6M-$22.9M$6.3M
Provision (benefit) for income taxes$81.8M-$4.0M$3.8M
Net income (loss)-$220.5M-$18.9M$2.5M
Basic (in dollars per share)-$3.74-$0.33$0.04
Diluted (in dollars per share)-$3.74-$0.33$0.04
Basic (in shares)58.9M shares58.1M shares57.4M shares
Diluted (in shares)58.9M shares58.1M shares57.6M shares

Compare Vanda Pharmaceuticals Inc. with another company

Corporate structure

Vanda Pharmaceuticals Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Vanda Pharmaceuticals Inc.

  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on Vanda Pharmaceuticals Inc., latest Oct 9, 2026 (4 filings since Jul 1, 2025)
  • AQR CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Vanda Pharmaceuticals Inc., latest Aug 13, 2026
  • State Street Corporation Filed SCHEDULE 13G on Vanda Pharmaceuticals Inc., latest May 12, 2026 (4 filings since Feb 14, 2022)
  • BlackRock Portfolio Management LLC Filed SCHEDULE 13G/A on Vanda Pharmaceuticals Inc., latest Apr 29, 2026 (3 filings since Apr 15, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Vanda Pharmaceuticals Inc., latest Mar 27, 2026 (4 filings since Feb 10, 2022)
  • BlackRock Filed SCHEDULE 13G/A on Vanda Pharmaceuticals Inc., latest Feb 7, 2025 (7 filings since Jan 26, 2022)
  • RENAISSANCE TECHNOLOGIES LLC Filed SC 13G/A on Vanda Pharmaceuticals Inc., latest Feb 13, 2024 (3 filings since Feb 11, 2022)
  • DIMENSIONAL FUND ADVISORS LP Filed SC 13G/A on Vanda Pharmaceuticals Inc., latest Feb 9, 2024 (2 filings since Feb 10, 2023)
  • Macquarie Group Filed SC 13G/A on Vanda Pharmaceuticals Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • Palo Alto Investors LP Filed SC 13G/A on Vanda Pharmaceuticals Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • ARMISTICE CAPITAL, LLC Filed SC 13G/A on Vanda Pharmaceuticals Inc., latest Feb 15, 2022
  • Vanda Pharmaceuticals Inc. Washington, the District of Columbia, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Vanda Pharmaceuticals 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, before depreciation$14.9M5 Dec 31, 2025$13.7M5 Dec 31, 2024+8.5%
Accumulated depreciation$12.6M5 Dec 31, 2025$11.6M5 Dec 31, 2024+9.1%
Property and equipment, net$2.2M5 Dec 31, 2025$2.1M5 Dec 31, 2024+5.4%
Finance-lease assets$7.3M5 Dec 31, 2025$4.9M5 Dec 31, 2024+48.6%
Operating-lease assets (leased space)$3.9M5 Dec 31, 2025$5.6M5 Dec 31, 2024−30.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$84.9M5 Dec 31, 2025$102.3M5 Dec 31, 2024−17.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$147.9M5 Dec 31, 2025$137.9M5 Dec 31, 2024+7.3%
Accumulated amortization$30.8M5 Dec 31, 2025$23.8M5 Dec 31, 2024+29.4%
Finite-lived intangibles, net$117.1M5 Dec 31, 2025$114.1M5 Dec 31, 2024+2.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$1.9M5 Dec 31, 2025$1.7M5 Dec 31, 2024+7.3%
Work in process$09 Dec 31, 2024$27.0K9 Dec 31, 2023−100.0%
Finished goods$1.9M5 Dec 31, 2025$1.7M5 Dec 31, 2024+7.3%

Properties, in its own words

Our headquarters office consists of a total of 43,462 square feet of office space located at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. under operating leases and subleases that expire between 2026 and 2028 and certain of these leases are subject to renewal options. In addition, we have 2,880 square feet of office space in London, England under an operating lease that has a lease term ending in 2026, and other short-term leases. We believe that these facilities are suitable and adequate

to meet our anticipated near-term needs. We anticipate that following the expiration of the leases, additional or alternative space will be available at commercially reasonable terms.

Item 2 of the 10-K filed Feb 12, 2026.4

Leadership

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

Board members and other officers (29)

Timeline

  1. Aug 5, 20268-K Results of operations47
  2. Jun 5, 20268-K Shareholder vote48
  3. May 6, 20268-K Results of operations49
  4. Apr 22, 20268-K Executive or director change50
  5. Apr 2, 20268-K Executive or director change51
  6. Mar 10, 20268-K Regulation FD disclosure52
  7. Feb 23, 20268-K Other events53
  8. Feb 19, 20268-K Executive or director change54
  9. Feb 11, 20268-K Results of operations55
  10. Jan 8, 20268-K Other events56
  11. Dec 31, 20258-K Other events57
  12. Dec 4, 20258-K Other events58
  13. Apr 12, 2006New chief executive Mihael Hristos Polymeropoulos becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.38) a share, on Oct 29, 2025.59

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results47
  2. May 6, 2026Reported quarterly or annual results49
  3. Feb 11, 2026Reported quarterly or annual results55
  4. Oct 29, 2025Reported quarterly or annual results60
  5. Jul 31, 2025Reported quarterly or annual results61
  6. May 7, 2025Reported quarterly or annual results62
  7. Feb 13, 2025Reported quarterly or annual results63
  8. Nov 6, 2024Reported quarterly or annual results64

Drug trials and FDA: coming up

  1. Oct 2026Phase 2 trial readout expected Phase 2 trial of iloperidone in Hypertension: primary completion expected Oct 2026 (ClinicalTrials.gov NCT07090161).65
  2. Dec 1, 2026Phase 3 trial readout expected Phase 3 trial of Tradipitant in Nausea and Vomiting: primary completion expected Dec 1, 2026 (ClinicalTrials.gov NCT07446439).66
  3. Dec 2026Phase 3 trial readout expected Phase 3 trial of VQW-765 in Social Anxiety Disorder (SAD): primary completion expected Dec 2026 (ClinicalTrials.gov NCT07221578).67
  4. Mar 2027Phase 1/2 trial readout expected Phase 1/2 trial of VCA-894A in Charcot Marie Tooth Disease (CMT): primary completion expected Mar 2027 (ClinicalTrials.gov NCT07223632).68
  5. Sep 30, 2027Phase 3 trial readout expected Phase 3 trial of Tradipitant in Motion Sickness: primary completion expected Sep 30, 2027 (ClinicalTrials.gov NCT06138613).69

Drug trials and FDA: recently

  1. Sep 4, 2026Phase 3 trial completed Phase 3 trial of Tasimelteon in Sleep Wake Disorders: primary completion Sep 4, 2026, no results posted yet (ClinicalTrials.gov NCT04652882).70
  2. Mar 30, 2026Phase 3 trial completed Phase 3 trial of Tradipitant in Idiopathic Gastroparesis: primary completion Mar 30, 2026, no results posted yet (ClinicalTrials.gov NCT06836557).71
  3. Feb 20, 2026FDA approval FDA approved Bysanti (milsaperidone), a new molecular entity (NDA 220358).72
  4. Dec 30, 2025FDA approval FDA approved Nereus (tradipitant), a new molecular entity (NDA 220152).73
  5. Feb 21, 2025Phase 3 trial completed Phase 3 trial of Tradipitant and Open Label Tradipitant in Idiopathic Gastroparesis: primary completion Feb 21, 2025, results posted Sep 24, 2026 (ClinicalTrials.gov NCT04028492).74
  6. Apr 2, 2024FDA approved a new use FDA approved an efficacy supplement for Fanapt (iloperidone), a new use or patient group (NDA 022192, supplement 23).75

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

284 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 69 major events, 109 insider forms, 33 large holders, 53 other. The latest 20:

  1. Oct 9, 2026SCHEDULE 13G/A EDGAR
  2. Aug 19, 2026SCHEDULE 13G EDGAR
  3. Aug 13, 2026SCHEDULE 13G EDGAR
  4. Aug 6, 202610-Q EDGAR
  5. Aug 5, 20268-K EDGAR
  6. Jun 8, 20264 EDGAR
  7. Jun 8, 20264 EDGAR
  8. Jun 8, 20264 EDGAR
  9. Jun 8, 20264 EDGAR
  10. Jun 8, 20264 EDGAR
  11. Jun 8, 20264 EDGAR
  12. Jun 8, 20264 EDGAR
  13. Jun 8, 20263 EDGAR
  14. Jun 5, 2026S-8 EDGAR
  15. Jun 5, 20268-K EDGAR
  16. May 20, 20264 EDGAR
  17. May 12, 2026SCHEDULE 13G EDGAR
  18. May 7, 202610-Q EDGAR
  19. May 6, 20268-K EDGAR
  20. May 5, 2026EFFECT EDGAR

The 284 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

65 open-market trades by officers, directors and large owners since October 2021: 11 buys and 54 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 2, 2026Moran Kevin PatrickSVP, CFO & TreasurerSale42,442$8.27$351.0KForm 4
Mar 2, 2026Wijkstrom JoakimSVP, Chief Marketing OfficerSale30,800$8.27$254.7KForm 4
Mar 2, 2026Williams TimothySVP & General CounselSale42,434$8.27$350.9KForm 4
Mar 2, 2026Birznieks GuntherSVP, Business DevelopmentSale42,431$8.27$350.9KForm 4
Mar 2, 2026Polymeropoulos Mihael HristosPresident and CEOSale156,235$8.17$1.3MForm 4
Feb 23, 2026Honore TageDirectorSale30,000$8.03$240.9KForm 4
Aug 7, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.15$41.5KForm 4
Jun 13, 2025Mitchell Stephen RayDirectorSale7,000$4.59$32.1KForm 4
May 21, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.40$44.0KForm 4
May 16, 2025Polymeropoulos Mihael HristosPresident and CEOBuy20,000$4.22$84.4KForm 4
Mar 6, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$5.01$50.1KForm 4
Mar 5, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$5.02$50.2KForm 4
Mar 3, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.71$47.1KForm 4
Feb 28, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.76$47.6KForm 4
Feb 27, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.76$47.6KForm 4
Feb 26, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.76$47.6KForm 4
Feb 25, 2025Polymeropoulos Mihael HristosPresident and CEOBuy10,000$4.46$44.6KForm 4
Feb 21, 2025Moran Kevin PatrickSVP, CFO & TreasurerBuy2,000$4.39$8.8KForm 4
Nov 14, 2024Mitchell Stephen RayDirectorSale5,000$5.17$25.9KForm 4
Jul 29, 2024Moran Kevin PatrickSVP, CFO & TreasurerSale2,251$5.92$13.3KForm 4

All 65 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
2025Mihael H. Polymeropoulos, M.D.President, Chief Executive Officer and Chairman of the Board66$965.7K$3.9M87
2025Joakim WijkstromSenior Vice President, Chief Marketing Officer$579.6K$1.5M87
2025Timothy WilliamsSenior Vice President, General Counsel and Secretary$559.9K$1.4M87
2025Kevin MoranSenior Vice President, Chief Financial Officer and Treasurer$559.9K$1.4M87
2025Gunther BirznieksSenior Vice President, Business Development$559.9K$1.4M87
2024Mihael H. Polymeropoulos, M.D.President, Chief Executive Officer and Chairman of the Board66$933.0K$3.9M87
2024Timothy WilliamsSenior Vice President, General Counsel and Secretary$541.0K$1.5M87
2024Kevin MoranSenior Vice President, Chief Financial Officer and Treasurer$541.0K$1.4M87
2024Gunther BirznieksSenior Vice President, Business Development$541.0K$1.4M87
2024Joakim WijkstromSenior Vice President, Chief Marketing Officer$560.0K$1.1M87
2023Mihael H. Polymeropoulos, M.D.President, Chief Executive Officer and Chairman of the Board66$897.0K$3.7M87
2023Timothy WilliamsSenior Vice President, General Counsel and Secretary$520.0K$1.4M87
2023Gunther BirznieksSenior Vice President, Business Development$520.0K$1.4M87
2023Joakim WijkstromSenior Vice President, Chief Marketing Officer$560.0K$1.4M87
2023Kevin MoranSenior Vice President, Chief Financial Officer and Treasurer$477.0K$1.3M87

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.7,653,737$46.8M0.0%+377,749
State Street Corp3,516,405$21.5M0.0%+500,843
Aqr Capital Management LLC3,497,695$21.4M0.0%+1,894,119
Renaissance Technologies LLC3,441,361$21.1M0.0%−318,198
Vanguard Capital Management LLC2,524,040$15.4M0.0%+42,549
AIGH Capital Management LLC2,044,169$12.5M1.1%−705,831
Dimensional Fund Advisors LP1,727,349$10.6M0.0%−44,244
Millennium Management LLC1,602,813$9.8M0.0%−278,188
Geode Capital Management, LLC1,483,787$9.1M0.0%+40,822
Two Sigma Investments, LP1,349,072$8.3M0.0%−49,129
Marshall Wace, Llp1,225,996$7.5M0.0%+629,994
Jacobs Levy Equity Management, Inc1,213,326$7.4M0.0%+44,645
Vanguard Portfolio Management LLC1,131,034$6.9M0.0%+116,512
Goldman Sachs Group Inc1,036,260$6.3M0.0%+198,027
Citadel Advisors LLC758,302$4.6M0.0%+124,948
Qube Research & Technologies Ltd729,212$4.5M0.0%New
Federated Hermes, Inc.714,278$4.4M0.0%+138,889
Charles Schwab Investment Management Inc646,256$4.0M0.0%+94,486
Northern Trust Corp600,619$3.7M0.0%+149,638
Morgan Stanley477,974$2.9M0.0%+37,180
Lionhunter Capital Management, LLC400,245$2.4M1.1%New
Vanguard Fiduciary Trust Co399,817$2.4M0.0%+11,853
Jump Financial, LLC339,907$2.1M0.0%+141,040
Quantinno Capital Management LP313,788$1.9M0.0%−13,405
Point72 Asset Management, L.P.311,362$1.9M0.0%+149,766

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

SEC filer profile

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

  • Name on EDGARVanda Pharmaceuticals Inc.1
  • CIK0001347178
  • Employer ID (EIN)03-04918274
  • Filer statusAccelerated 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 address2200 Pennsylvania Ave Nw, Suite 300E, Washington, DC 200371
  • Phone202-734-34001
  • Shares outstanding60,462,687 as of Jul 30, 202611
  • Public float$268.7M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Washington, District of Columbia PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceDec 29, 20051
  • Filings1,332 in all: 4 (507), 8-K (302), SC 13G/A (140), 10-Q (62), 3 (57), SC 13G (53), DEFA14A (24), S-8 (22)1
    All 38 form types

    10-K (20), DEF 14A (20), 144 (19), 4/A (9), UPLOAD (9), CORRESP (8), S-1/A (8), 424B5 (7), CT ORDER (7), SCHEDULE 13G/A (7), EFFECT (6), 5 (5), S-3 (5), SCHEDULE 13G (5), 8-K/A (4), ARS (4), 8-A12B/A (3), SC 13D/A (3), 10-K/A (2), 424B4 (2), 8-A12B (2), S-1 (2), 8-A12G (1), ARS/A (1), DFAN14A (1), PREC14A (1), S-1MEF (1), S-3/A (1), S-3MEF (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareVNDAThe Nasdaq Global Market

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

Risk factors and legal proceedings

The risks Vanda Pharmaceuticals Inc. names in Item 1A of its 10-K filed Feb 12, 2026: 63 risks under these headings, as written.4

  • Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our actual operating results and financial condition to vary materially from past, or anticipated future, operating results and financial condition. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and the price of our common stock.
  • Because of the following risk factors, as well as other risk factors affecting our financial condition and operating results, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods.
  • Risks Related to our Business and Industry
  • We are dependent on the commercial success of our commercial products. In the U.S., HETLIOZ® competes with generic versions of HETLIOZ® and we could experience increased generic competition in the near term.
  • As a result of the decision in favor of generic drug companies in connection with our HETLIOZ® patent litigation, we have faced generic competition and our revenues and results of operations could be further affected by the launch of additional generic versions of HETLIOZ® in the U.S.
  • Future performance of our commercial products may be impacted by a number of factors including competing products or unanticipated safety issues. If our commercial products are not successful in gaining broad commercial acceptance, our business would be harmed.
  • We are subject to uncertainty relating to pricing and reimbursement policies in the U.S., including recent and future health reform measures, which, if not favorable for our products, could hinder or prevent our products’ commercial success.
  • We have encountered third-party payors that refuse to cover or reimburse prescriptions written for HETLIOZ® and patients who are unable to navigate the coverage or reimbursement processes established by these third-party payors. If this trend continues, the commercial success of HETLIOZ® may be limited, and our business and results of operations may be materially harmed.
  • If the FDA does not approve our NDA filing for the use of NEREUSTM for patients with gastroparesis, our business may be harmed, and the market price of our stock could decline.
  • If the FDA does not approve our sNDAs for HETLIOZ® for the treatment of jet lag disorder or insomnia, continued development of HETLIOZ® for the treatment of jet lag disorder and insomnia may be significantly delayed or terminated, our business will be significantly harmed and the market price of our stock could decline.
  • We might not obtain the necessary regulatory approvals to commercialize current product candidates, including BysantiTM and imsidolimab.
  • Disruptions at the FDA and other government agencies caused by, among other things, government shutdowns, could hinder their ability to hire, retain or deploy key leadership and other personnel, conduct inspections of manufacturing facilities or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
The other 52 risks
  • Global economic conditions may have an adverse effect on our business.
  • Our business may be materially adversely affected by the imposition of duties and tariffs and other trade barriers and retaliatory countermeasures implemented by the U.S. and other governments.
  • Global health crises and pandemics may adversely impact our business.
  • We may enter into third-party collaborations from time to time in order to develop and commercialize our products. If we are unable to identify or enter into an agreement with any material third-party collaborator, if our collaborations with any such third party are not commercially successful or if our agreement with any such third party is terminated or allowed to expire, we could be adversely affected financially or our business reputation could be harmed.
  • Even after we obtain regulatory approvals of a product, acceptance of the product in the marketplace is uncertain and failure to achieve commercial acceptance will prevent or delay our ability to generate significant revenue from such product.
  • We rely on, and will continue to rely on, outsourcing arrangements for many of our activities, including preclinical and clinical development and supply of our commercial and other products.
  • Disruptions to our commercial products’ supply chains could materially affect our level of success in commercializing these products, thereby reducing our future earnings and prospects.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., 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 ongoing regulatory obligations and oversight of our products, and any failure by us to maintain compliance with applicable regulations may result in adverse consequences including the suspension of the manufacturing, marketing and sale of our respective products, the incurrence of significant additional expense and other limitations on our ability to commercialize our respective products.
  • If our products are marketed or distributed in a manner that violates federal or state healthcare fraud and abuse laws, marketing disclosure laws or other federal or state laws and regulations, we may be subject to civil or criminal penalties.
  • We rely on a limited number of specialty pharmacies for distribution of HETLIOZ® in the U.S., and the loss of one or more of these specialty pharmacies or their failure to distribute HETLIOZ® effectively would materially harm our business.
  • Our revenues from Fanapt® and PONVORY® are substantially dependent on sales through a limited number of customers, and such revenues may fluctuate from quarter to quarter.
  • We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
  • FDA and foreign regulatory approval of our products is uncertain.
  • Our products may cause undesirable side effects or have other properties that could delay, prevent or result in the revocation of their regulatory approval or limit their marketability.
  • Clinical trials for our products are expensive and their outcomes are uncertain. Any failure or delay in completing clinical trials for our products could severely harm our business.
  • We may not be able to achieve sustained profitability.
  • Our ability to use net operating loss (NOL) and tax credit carryforwards to offset future taxable income is dependent on generating future taxable income and may be limited, including as a result of transactions involving our common stock.
  • If we fail to adequately fund our research and development activities and commercialization efforts, we may be unable to continue operations or we may be forced to share our rights to commercialize our products with third parties on terms that may not be attractive to us.
  • If our contract research organizations (CROs), third-party vendors and investigators do not successfully carry out their duties or if we lose our relationships with CROs, third-party vendors and investigators, our drug development efforts could be delayed.
  • We rely on a limited number of third-party manufacturers to formulate and manufacture our products, and our business will be seriously harmed if these manufacturers are not able to satisfy our demand and alternative sources are not available.
  • Materials necessary to manufacture our products may not be available on commercially reasonable terms, or at all, which may delay the development, regulatory approval and commercialization of our products.
  • If we cannot identify, or enter into licensing arrangements for, new products, our ability to develop a diverse product portfolio will be limited.
  • If we lose key scientists or management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify, develop, and commercialize new products will be impaired.
  • Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.
  • E.U. Member States tend to impose strict price controls, which may delay or prevent the further commercial launch or impede the commercial success of HETLIOZ® in Europe and adversely affect our future results of operations.
  • We may not be able to effectively market and sell our future products, if approved, in the U.S.
  • Healthcare legislative reform measures or developments arising from changes in the political climate may have a material adverse effect on our business and results of operations.
  • We are subject to stringent laws, rules, regulations, policies, industry standards and contractual obligations regarding data privacy and security in foreign jurisdictions and may be subject to additional related laws, rules, regulations, policies, industry standards and contractual obligations in other jurisdictions into which we expand. Many of these provisions are
  • subject to change and reinterpretation depending on the jurisdiction and could result in claims, changes to our business practices, monetary penalties, increased cost of operations or other harm to our business activities.
  • Risks related to intellectual property and other legal matters
  • Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses or sublicenses granted to us by other pharmaceutical companies.
  • If our efforts to protect the proprietary nature of the intellectual property related to our products are not adequate, we may not be able to compete effectively in our markets.
  • We are, have been, and may continue to be, involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful, and third parties may challenge the validity or enforceability of our patents and they may be successful.
  • If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation to extend our patents and to obtain market exclusivity for our products, our business will be harmed.
  • Generic company competitors have received FDA approval of generic versions of HETLIOZ® in the U.S., which has harmed our business. We have not prevailed in our litigation against these competitors to date, and if additional efforts to protect our patents are unsuccessful, our business will be further harmed.
  • We may not be successful in the development of products for our own account.
  • Litigation or third-party claims of intellectual property infringement could require us to divert resources and may prevent or delay our drug discovery and development efforts.
  • General Risk Factors
  • Our stock price has been highly volatile and may be volatile in the future, and purchasers of our common stock could incur substantial losses.
  • We have been, and may in the future be, subject to litigation, which could harm our stock price, business, financial condition and results of operations.
  • If there are substantial sales of our common stock, our stock price could decline.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, our stock price and trading volume could decline.
  • Our common stock may experience future dilution as a result of future equity offerings.
  • Our business could be negatively affected as a result of the actions of activist stockholders.
  • Anti-takeover provisions in our charter and bylaws and under Delaware law, and the adoption of a rights plan, could prevent or delay a change in control of our company.
  • Changes to tax regulations to which we are subject could adversely affect us.
  • Future transactions may harm our business or the market price of our stock.
  • We may undertake strategic acquisitions in the future, and difficulties integrating such acquisitions could damage our ability to achieve or sustain profitability.
  • Our operating results may fluctuate significantly due to a number of factors which make our future results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • We are increasingly dependent on information technology systems, infrastructure and data. Cybersecurity breaches could expose us to liability, damage our reputation, compromise our confidential information or otherwise adversely affect our business.
  • Our internal computer systems, or those of our collaborators, CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates.
  • Natural disasters, public health crises, political crises, severe weather events, and other catastrophic events or other events outside of our control may damage our facilities or the facilities of third parties on which we depend and could impact our ability to sell products.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.

Legal proceedings

Information with respect to this item may be found in Note 18, Legal Matters, to the consolidated financial statements in Part II, Item 8 of this annual report on Form 10-K, which is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.4

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