FBIO on Nasdaq

Fortress Biotech

Logo: https://www.fortressbiotech.com/, Non-free logo, via Wikipedia5

Fortress Biotech Inc., commonly known as Fortress Bio, is a biopharmaceutical company that acquires, develops, and commercializes innovative pharmaceutical and biotechnology products. Led by CEO Lindsay A. Rosenwald, M.D., Fortress and most of its subsidiary companies are headquartered in Bay Harbor Islands, Florida.3 It was founded in 2006.1 It employed 34 people in 2016.1 Its shares trade on Nasdaq under the symbol FBIO.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

$63.3MRevenue, fiscal 20256
$6.8MNet income, fiscal 20256
2006Founded1

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  • TickerFBIO on Nasdaq1
  • Industryhealth care1
  • HeadquartersUnited States1
  • Websitewww.fortressbiotech.com
  • Legal formDelaware corporation1
  • Incorporated inDE7
  • Business address1111 Kane Concourse, Suite 301, Bay Harbor Islands, Fl 331547
  • Filer categoryNon-accelerated filer, Smaller reporting company7
  • LEI529900DZUWSYUURECK244
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressc/o COGENCY GLOBAL INC., 850 NEW BURTON ROAD SUITE 201, 19904 Dover, United States4
  • Registered withDivision of Corporations, Department of State, 41830184

Fortress Biotech Inc., commonly known as Fortress Bio, is a biopharmaceutical company that acquires, develops, and commercializes innovative pharmaceutical and biotechnology products. Led by CEO Lindsay A. Rosenwald, M.D., Fortress and most of its subsidiary companies are headquartered in Bay Harbor Islands, Florida.3

Financials

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

Key numbers, fiscal 2025

-111.0%Operating margin6
10.8%Net margin6
9.7%Revenue growth, 20256
13.7%Return on equity6
1.05×Debt to equity6

What sells

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

Products and services

Qbrexza brought in 41% of the revenue Fortress Biotech broke down this way in fiscal 2025.

  1. Qbrexza$25.0M641%down 0% from 2024
  2. Emrosi$14.7M624%
  3. Accutane$12.9M621%down 34% from 2024
  4. Foam Franchise Products$5.9M610%down 12% from 2024
  5. Other Legacy Product Revenue$2.7M64%down 31% from 2024
Products and services by year
Products and services20242025
Qbrexza$25.1M$25.0M
Emrosi$0$14.7M
Accutane$19.4M$12.9M
Foam Franchise Products$6.7M$5.9M
Other Legacy Product Revenue$4.0M$2.7M

Business segments

Journey brought in 98% of the revenue Fortress Biotech broke down this way in fiscal 2025.

  1. Journey$61.9M698%up 10% from 2024
  2. Avenue Therapeutics, Inc$1.4M62%
Business segments by year
Business segments20242025
Journey$56.1M$61.9M
Avenue Therapeutics, Inc$1.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue17¢$20.9M
  • Selling, general and admin77¢$96.4M
  • Income tax0¢$620.0K
  • Profit5¢$6.8M

Out of $63.3M in revenue.6

Financial statements

Revenue1011121314156$63.3M in 2025+135% since 2018
0$25.0M$50.0M$75.0M$100.0M2018: $26.9M$26.9M20182019: $36.6M$36.6M2019+36%2020: $45.6M$45.6M2020+24%2021: $68.8M$68.8M2021+51%2022: $75.7M$75.7M2022+10%2023: $84.5M$84.5M2023+12%2024: $57.7M$57.7M2024−32%2025: $63.3M$63.3M2025+10%
Operating income1011121314156-$70.2M in 2025−41% since 2018
-$300.0M-$200.0M-$100.0M02018: -$120.0M-$120.0M20182019: -$110.8M-$110.8M2019−8%2020: -$94.3M-$94.3M2020−15%2021: -$188.5M-$188.5M2021+100%2022: -$203.6M-$203.6M2022+8%2023: -$142.3M-$142.3M2023−30%2024: -$110.4M-$110.4M2024−22%2025: -$70.2M-$70.2M2025−36%
Net income1011121314156$6.8M in 2025
-$100.0M-$75.0M-$50.0M-$25.0M0$25.0M2018: -$84.1M-$84.1M20182019: -$40.0M-$40.0M2019−53%2020: -$46.5M-$46.5M2020+16%2021: -$64.7M-$64.7M2021+39%2022: -$86.6M-$86.6M2022+34%2023: -$60.6M-$60.6M2023−30%2024: -$46.0M-$46.0M2024−24%2025: $6.8M$6.8M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Product revenue, net$61.2M$55.1M
Collaboration revenue$1.5M
Other revenue$2.0M$1.0M
Net revenue$63.3M$57.7M
Cost of goods - (excluding amortization of acquired intangible assets)$20.9M$20.9M
Amortization of acquired intangible assets$4.3M$3.4M
Research and development$11.9M$56.6M
Research and development - licenses acquired$252.0K
Selling, general and administrative$96.4M$87.7M
Loss recovery-$4.6M
Asset impairment$0$3.7M
Total operating expenses$133.5M$168.1M
Loss from operations-$70.2M-$110.4M
Interest income$2.5M$2.7M
Interest expense and financing fee-$10.1M-$13.5M
Loss on common stock warrant liabilities-$398.0K-$638.0K
Gain from deconsolidation of subsidiary$27.1M$0
Other income$17.6M$1.3M
Total other income (expense)$36.7M-$10.2M
Loss before income tax expense-$33.5M-$120.5M
Income tax expense (benefit)-$620.0K$312.0K
Net loss-$32.9M-$120.9M
Attributable to non-controlling interests$39.7M$74.9M
Net income (loss) attributable to Fortress$6.8M-$46.0M
Preferred A dividends declared and paid and/or cumulated, and Fortress' share of subsidiary deemed dividends-$8.7M-$9.9M
Net loss attributable to common stockholders-$1.9M-$55.9M
Net loss per common share attributable to common stockholders - basic-$0.07-$2.69
Net loss per common share attributable to common stockholders - diluted-$0.07-$2.69
Weighted average common shares outstanding - basic27.9M shares20.8M shares
Weighted average common shares outstanding - diluted27.9M shares20.8M shares

Compare Fortress Biotech with another company

Corporate structure

Fortress Biotech sits at the top of its group. 14 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Fortress Biotech

  • Fortress Biotech New York, New York, United States
    • AVENUE THERAPEUTICS, INC. Stake · New York, New York, United States
    • Checkpoint Therapeutics, Inc. Stake · New York, New York, United States
    • Journey Medical Corp Stake · Scottsdale, Arizona
    • MUSTANG BIO, INC. Stake · New York, New York, United States
    • ● Aevitas Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Avenue Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Cellvation, Inc. Subsidiary · Delaware, United States
    • ● Cyprium Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Helocyte, Inc. Subsidiary · Delaware, United States
    • ● Journey Medical Corporation Subsidiary · Delaware, United States
    • ● Mustang Bio, Inc. Subsidiary · Delaware, United States
    • ● Oncogenuity, Inc. Subsidiary · Delaware, United States
    • ● Urica Therapeutics, Inc. Subsidiary · Delaware, 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; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (4 companies). Each entity in the chart links to its source.

What it owns

What Fortress Biotech 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$7.7M6 Dec 31, 2025$15.4M6 Dec 31, 2024−50.1%
Accumulated depreciation$3.0M6 Dec 31, 2025$9.9M6 Dec 31, 2024−70.1%
Property and equipment, net$2.5M6 Dec 31, 2025$3.3M6 Dec 31, 2024−22.7%
Operating-lease assets (leased space)$12.3M6 Dec 31, 2025$13.9M6 Dec 31, 2024−11.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$79.4M6 Dec 31, 2025$57.3M6 Dec 31, 2024+38.6%
Stakes in other companies (equity method)$15.1M6 Dec 31, 2025$300.0K20 Dec 31, 2017+4925.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$27.6M6 Dec 31, 2025$31.9M6 Dec 31, 2024−13.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$9.6M6 Dec 31, 2025$14.4M6 Dec 31, 2024−33.3%
Work in process$174.0K6 Dec 31, 2025$367.0K6 Dec 31, 2024−52.6%
Finished goods$7.4M6 Dec 31, 2025$11.4M6 Dec 31, 2024−35.1%

Properties, in its own words

We, and our subsidiaries and partner companies, primarily lease office space and other facilities as set forth in the table below. The only office space owned by us is our office space in Bay Harbor Islands, FL. We believe that our existing facilities are adequate to support our current requirements and that we will be able to obtain suitable additional facilities on commercially reasonable terms if needed.

Company · Location · Type · Square Footage

The rest of Item 2

Fortress · Bay Harbor Islands, FL · Office space · 1,600

Fortress · New York, NY1 · Office space · 23,000

Fortress · Waltham, MA · Office space · 6,100

Journey · Scottsdale, AZ · Office space · 3,801

Note 1: In February 2026, the Company entered into an agreement to sublease the entire space to a subtenant, which agreement will expire in August 2031.

Item 2 of the 10-K filed Mar 31, 2026.21

The story

The company was founded in 2006 under the name Coronado Biosciences, initially as an oncology company. In 2011, it was announced that Coronado raised $47.4 million in funding. Shortly thereafter it became a public company by registering all of its private shares as common stock. The company changed its name to Fortress Biotech in April 2015.

In November 2019, Fortress Biotech was ranked number 10 in the 2019 Deloitte Technology Fast 500 annual rankings.

From Wikipedia’s article on Fortress Biotech, shared under CC BY-SA 4.0.8

Leadership

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

Board members and other officers (21)

Products and brands

Subsidiaries

Fortress Bio has 10 biopharmaceutical subsidiary companies which cover a range of medical therapy areas, including potential cancer treatments and therapies for rare diseases and conditions. These subsidiaries include Aevitas Therapeutics (formed in 2017), Avenue Therapeutics (formed in 2015), Caelum Biosciences (formed in 2017), Cellvation (formed in 2016), Checkpoint Therapeutics (formed in 2015), Cyprium Therapeutics (formed in 2017), Helocyte (formed in 2015), Journey Medical Corporation (formed in 2014), Mustang Bio (formed in 2015), Tamid Bio (formed in 2017) and Baergic Bio (formed in 2019).

Products

Fortress Bio’s marketed products are developed and commercialized by its subsidiary Journey Medical Corporation. These include Targadox tablets indicated for acne, eczema emollient Ceracade, wound cream Luxamend, topical corticosteroid Triderm, topical broad-spectrum antifungal solution Exelderm, Ala-Quin topical cream for skin conditions, and Ala-Scalp hydrocortisone lotion for skin conditions.

From Wikipedia’s article on Fortress Biotech, shared under CC BY-SA 4.0.8

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ● Aevitas Therapeutics, Inc. Delaware9
  • ● Avenue Therapeutics, Inc. Delaware9
  • ● Cellvation, Inc. Delaware9
  • ● Cyprium Therapeutics, Inc. Delaware9
  • ● Helocyte, Inc. Delaware9
  • ● Journey Medical Corporation Delaware9
  • ● Mustang Bio, Inc. Delaware9
  • ● Oncogenuity, Inc. Delaware9
  • ● Urica Therapeutics, Inc. Delaware9

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

Employees over time

  • 2016341

Former names

  • Fortress Biotech, Inc.Apr 30, 2015 to Oct 1, 20267
  • CORONADO BIOSCIENCES INCMar 5, 2008 to Apr 27, 20157

Timeline

  1. Oct 1, 20268-K Other events47
  2. Aug 13, 20268-K Results of operations48
  3. Jun 23, 20268-K Shareholder vote49
  4. May 14, 20268-K Results of operations50
  5. Mar 31, 20268-K Results of operations51
  6. Mar 30, 20268-K Other events52
  7. Feb 23, 20268-K Entered a material agreement; New debt or obligation; Other events53
  8. Jan 13, 20268-K Other events54
  9. Dec 15, 20258-K Other events55
  10. Dec 15, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares56
  11. Nov 17, 20258-K Other events57
  12. Nov 14, 20258-K Results of operations58
  13. Dec 23, 2013New chief executive Lindsay A. Rosenwald Md. becomes CEO23
  14. Jan 9, 2013New chief executive Harlan F. Weisman becomes CEO22
  15. Sep 13, 2011New chief executive Bobby W. Sandage Phd. becomes CEO24
  16. 2006Founded Founded1

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202659

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results48
  2. May 14, 2026Reported quarterly or annual results50
  3. Mar 31, 2026Reported quarterly or annual results51
  4. Nov 14, 2025Reported quarterly or annual results58
  5. Aug 14, 2025Reported quarterly or annual results60
  6. May 15, 2025Reported quarterly or annual results61
  7. Mar 31, 2025Reported quarterly or annual results62
  8. Nov 14, 2024Reported quarterly or annual results63

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

Filings

257 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 64 major events, 78 insider forms, 14 large holders, 81 other. The latest 20:

  1. Oct 1, 20264 EDGAR
  2. Oct 1, 20268-K EDGAR
  3. Sep 1, 2026SCHEDULE 13G EDGAR
  4. Aug 13, 202610-Q EDGAR
  5. Aug 13, 20268-K EDGAR
  6. Jun 24, 20264 EDGAR
  7. Jun 23, 20268-K EDGAR
  8. May 15, 2026SCHEDULE 13G/A EDGAR
  9. May 14, 202610-Q EDGAR
  10. May 14, 20268-K EDGAR
  11. Apr 28, 2026DEFA14A EDGAR
  12. Apr 28, 2026DEF 14A EDGAR
  13. Apr 1, 20264 EDGAR
  14. Mar 31, 202610-K EDGAR
  15. Mar 31, 20268-K EDGAR
  16. Mar 30, 20268-K EDGAR
  17. Mar 20, 2026SCHEDULE 13D/A EDGAR
  18. Mar 20, 20264 EDGAR
  19. Mar 20, 20264 EDGAR
  20. Feb 23, 20268-K EDGAR

The 257 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

25 open-market trades by officers, directors and large owners since October 2021: 23 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 23, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy763,359$1.84$1.4MForm 4
Jul 11, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy5,000$7.48$37.4KForm 4
Jul 10, 2024Jin DavidChief Financial OfficerBuy500$7.50$3.8KForm 4
Jul 9, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy5,000$7.39$37.0KForm 4
Jul 8, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy5,000$7.35$36.8KForm 4
Jun 28, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy20,000$1.64$32.8KForm 4
May 20, 2024Klein DovDirectorSale10,000$1.89$18.9KForm 4
May 16, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy10,000$1.76$17.6KForm 4
Jan 5, 2024ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy50,000$2.38$119.0KForm 4
Nov 14, 2023ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy1,567,515$1.70$2.7MForm 4
Nov 14, 2023WEISS MICHAEL SExecutive Vice ChairmanBuy147,058$1.70$250.0KForm 4
Sep 26, 2023ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy100,000$0.28$28.0KForm 4
Aug 18, 2023ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy10,000$9.34$93.4KForm 4
Aug 17, 2023ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy10,000$11.75$117.5KForm 4
Feb 10, 2023WEISS MICHAEL SExecutive Vice ChairmanBuy1,197,604$0.84$1.0MForm 4
Feb 10, 2023Rowinsky Eric KDirectorBuy11,976$0.84$10.1KForm 4
Feb 10, 2023ROSENWALD LINDSAY A MDPRESIDENT, CEO & CHAIRMANBuy2,395,209$0.84$2.0MForm 4
Feb 10, 2023Lu LucyDirectorBuy11,976$0.84$10.1KForm 4
Feb 10, 2023LOBELL J JAYDirectorBuy299,401$0.84$251.5KForm 4
Feb 10, 2023Jin DavidChief Financial OfficerBuy35,928$0.84$30.2KForm 4

All 25 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

Fortress Biotech has told the SEC it owns more than 5% of 4 companies, 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
2025ChairmanPresident and$62.7K$2.9M75
2025Executive ViceChairman,$62.7K$2.4M75
2025Chief Financial Officer and$427.9K$664.1K75
2024Head of Corporate Development$420.0K$2.6M75
2024Chief Executive Officer$62.7K$1.4M75
2024Strategic Development$62.7K$1.2M75

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 54. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC1,037,203$3.2M0.0%+71,173
Opaleye Management Inc.890,000$2.7M0.2%−152,000
Mackenzie Financial Corp555,676$1.7M0.0%New
Geode Capital Management, LLC300,521$919.9K0.0%+10,266
BlackRock, Inc.224,782$687.8K0.0%+27,697
Two Sigma Investments, LP213,786$654.2K0.0%+16,961
Bridgeway Capital Management, LLC177,368$542.7K0.0%−5,000
Vanguard Fiduciary Trust Co166,371$509.1K0.0%+23,836
HB Wealth Management, LLC116,675$357.0K0.0%−3,500
Kestra Advisory Services, LLC116,235$355.7K0.0%−13,566
State Street Corp101,601$310.9K0.0%No change
Goldman Sachs Group Inc96,358$294.9K0.0%New
Integrated Wealth Concepts LLC90,400$276.6K0.0%+45,200
Renaissance Technologies LLC86,390$264.4K0.0%−13,200
Citadel Advisors LLC77,065$235.8K0.0%−103,224
Integrated Quantitative Investments LLC68,692$210.2K0.0%New
Panagora Asset Management Inc66,025$202.0K0.0%+9,357
Northern Trust Corp63,632$194.7K0.0%−166,421
180 Wealth Advisors, LLC61,600$188.5K0.0%−2,200
UBS Group AG52,346$160.2K0.0%+37,873
Susquehanna International Group, Llp47,002$143.8K0.0%−163,743
Prelude Capital Management, LLC41,507$127.0K0.0%New
PFG Investments, LLC36,501$111.7K0.0%No change
Choreo, LLC36,250$110.9K0.0%No change
Jane Street Group, LLC25,414$77.8K0.0%−15,520

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

SEC filer profile

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

  • Name on EDGARFortress Biotech, Inc.2
  • CIK0001429260
  • Employer ID (EIN)20-515738621
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company21
  • Incorporated inDelaware21
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 331542
  • Phone781-652-45002
  • Shares outstanding32,202,564 Common Stock shares; 3,427,138 Series Cumulative Redeemable Perpetual Preferred Stock shares as of Mar 25, 202621
  • Public float$43.7M as of Jun 30, 202521
  • AuditorKPMG LLP, New York, NY PCAOB ID 185; no auditor attestation of internal control over financial reporting21
  • On EDGAR sinceMar 5, 20082
  • Filings885 in all: 4 (251), 8-K (221), 10-Q (45), 3 (33), SC 13D/A (27), 424B5 (22), EFFECT (22), CORRESP (21)2
    All 47 form types

    SC 13G/A (19), DEF 14A (18), DEFA14A (18), UPLOAD (18), 10-K (15), 424B3 (13), SC 13G (13), S-3 (11), S-8 (11), SCHEDULE 13D/A (11), D (9), POS AM (9), FWP (8), PRE 14A (8), S-3/A (8), SC 13D (7), 4/A (5), CT ORDER (5), S-1 (4), S-1/A (4), 10-12G/A (3), 10-K/A (3), 8-A12B (2), 8-K/A (2), CERTNAS (2), PX14A6G (2), SC TO-C (2), SC TO-T/A (2), 10-12G (1), 10-Q/A (1), 144 (1), 424B4 (1), 424B7 (1), D/A (1), REGDEX (1), S-1MEF (1), SC TO-T (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common StockFBIONasdaq
9.375% Series A Cumulative Redeemable Perpetual Preferred StockFBIOPNasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).21

Risk factors and legal proceedings

The risks Fortress Biotech names in Item 1A of its 10-K filed Mar 31, 2026: 67 risks under these headings, as written.21

  • Most of our product candidates are in the early stages of development and may not be successfully developed or commercialized, and the product candidates that do advance into clinical trials may not receive regulatory approval.
  • The extensive regulation to which our product candidates are subject may be costly and time consuming, cause anticipated or unanticipated delays, and/or prevent the receipt of the required approvals for commercialization.
  • Delays in the commencement of our clinical trials, or suspensions or terminations of such trials, could result in increased costs and/or delay our ability to pursue regulatory approvals.
  • Suspensions or delays in the completion of clinical testing could result in increased costs and/or delay or prevent our ability to complete development of that product candidate or generate product revenues.
  • If our competitors develop treatments for any of our product candidates’ target indications and those competitor products are approved more quickly, marketed more successfully or demonstrated to be more effective, the commercial opportunity for our product candidates will be reduced or eliminated.
  • Negative public opinion and increased regulatory scrutiny of the therapies that underpin many of our product candidates may damage public perception of our product candidates, or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
  • The making, use, sale, importation, exportation and distribution of controlled substances are subject to regulation by state, federal and foreign law enforcement and other regulatory agencies.
  • The FDA limits regulatory approval for our product candidates to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
  • If the FDA does not conclude that a product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidate under Section 505(b)(2) are not as we expect, the approval pathway for the product candidate will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.
  • We have historically financed a significant portion of our growth and operations in part through the assumption of debt. Should an event of default occur under any applicable loan documents, our business would be materially adversely affected. Further, our current credit arrangement with Oaktree restricts our and certain of our subsidiaries’ and partner companies’ abilities to take certain actions.
  • We have a history of operating losses that is expected to continue, and we are unable to predict the extent of future losses, whether we will be able to sustain current revenues or whether we will ever achieve or sustain profitability.
The other 55 risks
  • To fund our operations and service our debt securities, which may be deemed to include our Series A Preferred Stock, we will be required to generate a significant amount of cash. Our ability to generate cash depends on a number of factors, some of which are beyond our control, and any failure to meet our debt obligations would have a material adverse effect on our business, financial condition, cash flows and results of operations and could cause the market value of our Common Stock and/or Series A Preferred Stock to decline.
  • We may need substantial additional funding and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate one or more of our R&D programs, commercialization efforts or planned acquisitions and potentially change our growth strategy.
  • We may be unable to generate returns for our investors if our partner companies and subsidiaries, several of which have limited or no operating history, have no commercialized revenue generating products or, if not yet profitable, cannot obtain additional third-party financing.
  • Raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
  • We have paused dividend payments on our Series A Preferred Stock and may not be able to resume payment of dividends on our Series A Preferred Stock in the future if we have insufficient cash or available “surplus” as defined under Delaware law to make such dividend payments.
  • Because we have paused dividend payments on our Series A Preferred Stock, we are currently ineligible to file new short-form registration statements on Form S-3, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all.
  • We have never paid and currently do not intend to pay cash dividends in the near future, except for the dividend we previously paid on our Series A Preferred Stock. As a result, capital appreciation, if any, will be the sole source of gain for our Common Stockholders.
  • We have historically relied in part on sales of our Common Stock and other securities to fund our operations, and our future ability to obtain additional capital through stock sales or other securities offerings may be more costly than in the past, or may not be available to us at all.
  • Future revenue based on sales of our dermatology products, Qbrexza, Accutane, Amzeeq, Zilxi, Targadox, Exelderm, Luxamend and Emrosi, may be lower than expected or lower than in previous periods.
  • We face challenges as our products face generic competition and/or losses of exclusivity.
  • Any disruptions to the capabilities, composition, size or existence of Journey’s field sales force may have a significant adverse impact on our existing revenue stream. Further, our ability to effectively market and sell any future products that we may develop and for which we receive marketing authorization, will depend on our ability to establish and maintain sales and marketing capabilities or to enter into agreements with third parties to market, distribute and sell any such products.
  • If our products are not included in managed care organizations’ formularies or coverage by other organizations, our products’ utilization and market shares may be negatively impacted, which could have a material adverse effect on our business and financial condition.
  • Reimbursement for our products and product candidates may be limited or unavailable in certain market segments, which could make it difficult for us to sell our products profitably.
  • Our products and future product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could harm our business.
  • The Company’s 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.
  • Our future growth depends in part on our ability to identify and acquire or in-license products and product candidates, and if we are unable to do so, or to integrate acquired products into our operations, we may have limited growth opportunities.
  • Certain of our officers and directors serve in similar roles at our partner companies, subsidiaries, related parties and/or other entities with which we transact business or in which we hold significant minority ownership positions, which could result in conflicts of interests relating to ongoing and future relationships and transactions with these parties.
  • Certain of our executives, directors and principal stockholders, whose interests may be adverse to those of our other stockholders, can control our direction and policies.
  • If we acquire, enter into joint ventures with or obtain a controlling interest in, companies in the future, our financial condition, operating results and the value of our Securities may be adversely affected, thereby diluting stockholder value, disrupting our business and/or diminishing the value of our holdings in our partner companies.
  • Our results of operations could be adversely affected by economic and political conditions and the effects of these conditions on our business activities.
  • We rely predominantly on third parties to manufacture the majority of our preclinical and clinical pharmaceutical supplies, and we expect to rely heavily on such third parties and other contractors to produce commercial supplies of our product candidates and products, if approved. Further, we rely solely on third parties to manufacture Journey’s commercialized products. Such dependence on third-party suppliers could adversely impact our businesses.
  • We rely heavily on third parties for the development and manufacturing of products and product candidates.
  • We rely on third parties to conduct clinical trials. If these third parties do not meet agreed-upon deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.
  • We rely on clinical and pre-clinical data and results obtained from and by third parties that could ultimately prove to be inaccurate or unreliable.
  • Collaborative relationships with third parties could cause us to expend significant resources and/or incur substantial business risk with no assurance of financial return.
  • The contractual provisions we may be forced to agree upon in services, manufacturing, supply and other agreements may be inordinately one-sided, vis-à-vis current or historical standard market terms (especially as pertains contractual liability and indemnification paradigms), and as a result we may be subject to liabilities that are not attributable to our own actions or the actions of our personnel.
  • If we are unable to obtain and maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • If we or our licensors are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of licensors, which could be expensive, time consuming and unsuccessful.
  • We in-license from third parties a majority of the intellectual property needed to develop and commercialize products and product candidates. As such, any dispute with the licensors or non-performance of such license agreements may adversely affect our ability to develop and commercialize the applicable product candidates.
  • If any of our product candidates are successfully developed and receive regulatory approval but do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that any such product candidates, if approved, generate from sales will be limited.
  • Even if approved, any product candidates that we may develop and market may be later withdrawn from the market or subject to promotional limitations.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for one or more of our product candidates or a future product candidate we may license or acquire and may have to limit their commercialization, if approved.
  • Any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with products, when and if any of them are approved.
  • We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.
  • Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • As we continue to execute our growth strategy, we may be subject to further government regulation which could adversely affect our financial results, including without limitation the Investment Company Act of 1940.
  • Recent U.S. Supreme Court decisions could create uncertainty in the life sciences space that could negatively impact our business.
  • Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.
  • We may not be able to hire or retain key officers or employees needed to implement our business strategy and develop products and businesses.
  • Our employees, consultants, or third-party partners may engage in misconduct or other improper activities, including but not necessarily limited to noncompliance with regulatory standards and requirements or internal procedures, policies or agreements to which such employees, consultants and partners are subject, any of which could have a material adverse effect on our business.
  • We may be subject to claims that our employees and/or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients.
  • The market price of our securities may be volatile and may fluctuate in a way that is disproportionate to our operating performance.
  • Sales or other issuances of a substantial number of shares of our Common Stock, or the perception that such sales or issuances may occur, may adversely impact the price of our Common Stock.
  • We may not be able to manage our anticipated growth, which may in turn adversely impact our business.
  • A catastrophic disaster could damage our facilities beyond insurance limits or cause us to lose key data, which could cause us to curtail or cease operations.
  • Our ability to use our pre-change NOLs and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • The use of artificial intelligence in the healthcare industry and challenges with properly managing its use could adversely affect our business.
  • Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business or the business of our partners.
  • We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives. Also, if we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our Securities.
  • Provisions in our certificate of incorporation, our bylaws and Delaware law might discourage, delay or prevent a change in control of our Company or changes in our management and, therefore, depress the trading price of our Common Stock or other Securities.
  • If we fail to comply with the continuing listing standards of Nasdaq, our Common Stock could be delisted from the exchange.
  • Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations.
  • Fluctuations in interest rates may negatively impact the rate of return that we realize on the investment securities that we hold.

Legal proceedings

To our knowledge, there are no material legal proceedings pending against us, other than routine actions and administrative proceedings, and other actions we have deemed not material and not expected to have, individual or in the aggregate, a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, however, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, negligence and other matters, and seeking resulting alleged damages.

The opening of Item 3, Legal Proceedings.21

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