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.1Wikipedia text CC BY-SA 4.0
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.
Revenue161718$18.7M in Q2 FY2026+14% since Q2 FY2025Operating income161718-$10.0M in Q2 FY2026−73% since Q2 FY2025Net income161718-$468.0K in Q2 FY2026
Every line of the income statement as filed: the last 2 fiscal years, latest first.6
Period ending
2025-12-31
2024-12-31
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 - basic
27.9M shares
20.8M shares
Weighted average common shares outstanding - diluted
27.9M shares
20.8M shares
No quarter-by-quarter statement was filed.
Total assets1011121314156$185.5M in 2025+32% since 2018Total liabilities1011121314156$123.4M in 2025+2% since 2018Shareholders’ equity1011121314156$49.9M in 2025+2593% since 2018Cash1011121314156$79.4M in 2025+21% since 2018Long-term debt1011121314156$52.4M in 2025−38% since 2018
Total assets161718$316.7M in Q2 FY2026+98% since Q2 FY2025Total liabilities19171816$110.6M in Q2 FY2026−10% since Q2 FY2025Shareholders’ equity19171816$164.1M in Q2 FY2026+274% since Q2 FY2025Cash161718$196.6M in Q2 FY2026+164% since Q2 FY2025Long-term debt19171816$35.0M in Q2 FY2026−30% since Q2 FY2025
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.6
Period ending
2025-12-31
2024-12-31
2023-12-31
Cash and cash equivalents
$79.4M
$57.3M
Accounts receivable, net
$29.8M
$10.2M
Inventory
$9.6M
$14.4M
Prepaid expenses and other current assets
$4.9M
$7.1M
Assets held for sale
$0
$1.2M
Total current assets
$123.8M
$90.4M
Property, plant and equipment, net
$2.5M
$3.3M
Operating lease right-of-use asset, net
$12.3M
$13.9M
Restricted cash
$1.2M
$1.6M
Equity investments, at fair value
$17.7M
$2.6M
Intangible assets, net
$27.6M
$31.9M
Other assets
$401.0K
$731.0K
Total assets
$185.5M
$144.2M
Accounts payable and accrued expenses
$47.1M
$65.5M
Income taxes payable
$356.0K
$932.0K
Common stock warrant liabilities
$1.0K
$214.0K
Operating lease liabilities, short-term
$2.1M
$2.6M
Partner company installment payments - licenses, short-term
$0
$625.0K
Other current liabilities
$135.0K
$1.5M
Total current liabilities
$49.7M
$71.4M
Notes payable, long-term, net
$52.4M
$58.0M
Operating lease liabilities, long-term
$12.7M
$14.8M
Partner company redeemable perpetual preferred liability
$7.1M
$0
Other long-term liabilities
$1.4M
$1.8M
Total liabilities
$123.4M
$145.9M
Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively, liquidation value of $25.00 per share
$3.0K
$3.0K
Common stock, $0.001 par value, 200,000,000 shares authorized, 31,364,094 and 27,908,839 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
$31.0K
$28.0K
Additional paid-in-capital
$783.9M
$763.6M
Accumulated deficit
-$734.1M
-$740.9M
Total stockholders' equity attributed to the Company
$49.9M
$22.7M
Non-controlling interests
$12.3M
-$24.4M
Total stockholders' equity (deficit)
$62.2M
-$1.6M
$1.6M
Total liabilities and stockholders' equity (deficit)
$185.5M
$144.2M
Preferred Stock, par value
$0.00
$0.00
Preferred Stock, shares authorized
15.0M shares
15.0M shares
Preferred Stock shares designated
5.0M shares
5.0M shares
Preferred Stock, shares issued
3.4M shares
3.4M shares
Preferred Stock, shares outstanding
3.4M shares
3.4M shares
Preferred Stock, liquidation preference per share
$25
$25
Common Stock, par value
$0.00
$0.00
Common Stock, shares authorized
200.0M shares
200.0M shares
Common Stock, shares issued
31.4M shares
27.9M shares
Common Stock, shares outstanding
31.4M shares
27.9M shares
Period ending
2025-12-31
2024-12-31
2023-12-31
Cash and cash equivalents
$79.4M
$57.3M
Accounts receivable, net
$29.8M
$10.2M
Inventory
$9.6M
$14.4M
Prepaid expenses and other current assets
$4.9M
$7.1M
Assets held for sale
$0
$1.2M
Total current assets
$123.8M
$90.4M
Property, plant and equipment, net
$2.5M
$3.3M
Operating lease right-of-use asset, net
$12.3M
$13.9M
Restricted cash
$1.2M
$1.6M
Equity investments, at fair value
$17.7M
$2.6M
Intangible assets, net
$27.6M
$31.9M
Other assets
$401.0K
$731.0K
Total assets
$185.5M
$144.2M
Accounts payable and accrued expenses
$47.1M
$65.5M
Income taxes payable
$356.0K
$932.0K
Common stock warrant liabilities
$1.0K
$214.0K
Operating lease liabilities, short-term
$2.1M
$2.6M
Partner company installment payments - licenses, short-term
$0
$625.0K
Other current liabilities
$135.0K
$1.5M
Total current liabilities
$49.7M
$71.4M
Notes payable, long-term, net
$52.4M
$58.0M
Operating lease liabilities, long-term
$12.7M
$14.8M
Partner company redeemable perpetual preferred liability
$7.1M
$0
Other long-term liabilities
$1.4M
$1.8M
Total liabilities
$123.4M
$145.9M
Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively, liquidation value of $25.00 per share
$3.0K
$3.0K
Common stock, $0.001 par value, 200,000,000 shares authorized, 31,364,094 and 27,908,839 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
$31.0K
$28.0K
Additional paid-in-capital
$783.9M
$763.6M
Accumulated deficit
-$734.1M
-$740.9M
Total stockholders' equity attributed to the Company
$49.9M
$22.7M
Non-controlling interests
$12.3M
-$24.4M
Total stockholders' equity (deficit)
$62.2M
-$1.6M
$1.6M
Total liabilities and stockholders' equity (deficit)
$185.5M
$144.2M
Preferred Stock, par value
$0.00
$0.00
Preferred Stock, shares authorized
15.0M shares
15.0M shares
Preferred Stock shares designated
5.0M shares
5.0M shares
Preferred Stock, shares issued
3.4M shares
3.4M shares
Preferred Stock, shares outstanding
3.4M shares
3.4M shares
Preferred Stock, liquidation preference per share
$25
$25
Common Stock, par value
$0.00
$0.00
Common Stock, shares authorized
200.0M shares
200.0M shares
Common Stock, shares issued
31.4M shares
27.9M shares
Common Stock, shares outstanding
31.4M shares
27.9M shares
Cash from operations1011121314156-$65.8M in 2025−33% since 2018Capital spending101112131415$0 in 2024Free cash flow1011121314156-$80.2M in 2024−24% since 2018Dividends paid11121314156$664.0K in 2025Share buybacks1112$70.0K in 2020
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.6
Period ending
2025-12-31
2024-12-31
Net income (loss)
-$32.9M
-$120.9M
Depreciation expense
$403.0K
$1.0M
Loss on disposal of property and equipment
$0
$29.0K
Bad debt (recovery) expense
-$211.0K
$516.0K
Amortization of debt discount
$1.4M
$2.1M
Accretion of partner company convertible preferred shares
$0
-$737.0K
Gain on termination of partner company lease
-$394.0K
$0
Loss on extinguishment of debt
$0
$2.5M
Amortization of acquired intangible assets
$4.3M
$3.4M
Settlement of partner company payables
-$2.1M
$0
Reduction in the carrying amount of operating lease right-of-use assets
$1.9M
$2.8M
Stock-based compensation expense
$28.7M
$32.6M
Change in fair value of investment
-$15.1M
$0
Common shares issued for dividend on partner company's convertible preferred shares
$0
$114.0K
Change in fair value of partner companies' warrant liabilities
$398.0K
$487.0K
Research and development - licenses acquired, expense
$0
$250.0K
Gain from deconsolidation of subsidiary
-$27.1M
$0
Asset impairment loss
$0
$3.7M
Accounts receivable
-$19.3M
$4.5M
Inventory
$4.8M
-$4.2M
Other receivables - related party
$13.0K
-$4.0K
Prepaid expenses and other current assets
$1.5M
-$624.0K
Other assets
$330.0K
$968.0K
Accounts payable and accrued expenses
-$8.0M
-$6.4M
Income taxes payable
-$576.0K
$89.0K
Lease liabilities
-$2.2M
-$3.6M
Other liabilities
-$1.7M
$1.2M
Net cash used in operating activities
-$65.8M
-$80.2M
Acquired intangible assets
$0
-$15.0M
Proceeds from sale of property and equipment
$1.2M
$0
Net cash increase upon deconsolidation of subsidiary
$9.0M
$0
Net cash provided by (used in) investing activities
$10.1M
-$15.0M
Payment of Series A perpetual preferred stock dividends
$0
-$4.0M
Proceeds from issuance of common stock for public offering, net
$0
$17.4M
Proceeds from issuance of common stock for at-the-market offering, net
$1.0M
$3.7M
Proceeds from issuance of common stock under ESPP
$87.0K
$101.0K
Exercise of warrants for cash
$2.6M
$181.0K
Proceeds from partner companies' ESPP
$217.0K
$257.0K
Partner company's dividends declared and paid
-$664.0K
-$694.0K
Partner company's redemption of preferred shares
-$265.0K
$0
Proceeds from partner companies' equity offerings and warrant exercises, net
$61.6M
$49.7M
Proceeds from partner companies' at-the-market offering, net
$19.1M
$12.0M
Proceeds from exercise of partner company's options, net
$0
$207.0K
Repayment of Oaktree Note and debt issuance costs
-$5.6M
-$51.0M
Repayment of partner company installment payments - licenses
-$625.0K
-$1.2M
Stock and warrants issued for exchange of partner company preferred shares
$0
$341.0K
Proceeds from long-term debt, net
-$75.0K
$33.7M
Proceeds from partner company's long-term debt, net
$0
$9.9M
Net cash provided by financing activities
$77.4M
$70.6M
Net increase (decrease) in cash and cash equivalents and restricted cash
$21.8M
-$24.6M
Cash paid for interest
$7.4M
$7.2M
Cash paid for income taxes
$49.0K
$120.0K
Exchange of partner company convertible preferred shares for common shares
$0
$3.4M
Fair value of assets received by partner company in repurchase transaction
$0
$2.2M
Fair value of supplies received by partner company expensed to research and development
$0
$2.5M
Partner company accounts receivable write-off related to repurchase transaction
$0
-$7.0M
Partner company accounts payable write-off related to repurchase transaction
$0
$3.6M
Partner company's deferred purchase consideration
$0
$1.3M
Warrants issued in conjunction with debt
$1.3M
$1.1M
Unpaid research and development licenses acquired
$0
$250.0K
Lease Liabilities arising from obtaining right-of-use assets
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.
● 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.
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.
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.
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.
Nov 13, 2026Reports results for the quarter ending Sep/202659
When it reported results
Aug 13, 2026Reported quarterly or annual results48
May 14, 2026Reported quarterly or annual results50
Mar 31, 2026Reported quarterly or annual results51
Nov 14, 2025Reported quarterly or annual results58
Aug 14, 2025Reported quarterly or annual results60
May 15, 2025Reported quarterly or annual results61
Mar 31, 2025Reported quarterly or annual results62
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:
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.
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.
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.
9.375% Series A Cumulative Redeemable Perpetual Preferred Stock
FBIOP
Nasdaq
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.