Journey Medical (DERM) risk factors, FY2024 10-K

Risks Related to Our Business, Industry and Existing Operating Revenue Stream

1. 01Future revenue from sales of our dermatology products may be lower than expected or lower than in previous periods
2. 02We face challenges as our products face generic competition and/or losses of exclusivity
3. 03challenged through litigation or in USPTO proceedings, if a generic company launches a competing product “at risk,” or when the regulatory or licensed exclusivity for our products expires or is otherwise lost, we may face generic competition as a result
4. 04Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated
5. 05If serious adverse or unacceptable side effects are identified during the development of any future product candidates, we may need to abandon or limit our development of these product candidates
6. 06All of our current and future products will remain subject to substantial regulatory scrutiny even after receiving regulatory approval
7. 07Violations of the FDCA relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws
8. 08Our 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
9. 09Public concern regarding the safety of any of our products and any future product candidates could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to incur additional costs
10. 10commercial use. If any future product candidates receive(s) marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the product
11. 11If we experience delays or difficulties in the enrollment of patients in any future clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
12. 12We expect intense competition for our products and any future product candidates, and new products may emerge that provide different or better therapeutic alternatives for our targeted indications
13. 13If our products do not achieve broad market acceptance, including by government and third-party payors, the revenues that we generate from sales will be limited

Risks Related to Our Reliance on Third Parties

1. 14We rely, and expect to continue to rely, on third parties to conduct any future preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such trials or to comply with applicable regulatory requirements
2. 15We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable
3. 16If successful product liability claims are brought against us, we may incur substantial liability, and may have to limit the commercialization of certain current or future products or product candidates
4. 17The use of artificial intelligence in the healthcare industry and challenges with properly managing its use could adversely affect our business

Risks Related to our Growth

1. 18A significant part of our future growth may depend on our ability to identify and acquire or in-license products, and if we do not successfully identify and acquire or in-license related product candidates or integrate them into our operations, we may have limited growth opportunities
2. 19Our growth is subject to economic and political conditions
3. 20We may not be able to manage our business effectively if we are unable to attract and retain key personnel
4. 21We may decide to sell assets, which could adversely affect our prospects and opportunities for growth
5. 22There is substantial doubt regarding our ability to continue as a going concern. We may need to raise additional funding (which may not be available on acceptable terms to the Company, or at all) and/or to delay, limit or terminate certain of our product development and commercialization efforts or other operations

Risks Related to Development and Regulatory Approval of Our Future Product Candidates

1. 23Our business is dependent on the successful development and regulatory approval of our current and any future product candidates
2. 24The success of our business, including our ability to finance our company and generate additional revenue in the future, may depend on the successful development and marketing of Emrosi and any future product candidates that we may develop, in-license or acquire
3. 25Clinical drug development is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately demonstrate the safety and efficacy of any future product candidates, which could prevent or delay regulatory approval and commercialization
4. 26We are currently dependent on DRL for the manufacture and clinical supply of Emrosi drug product. Any interruption in our supply may cause serious delays in the timing of our clinical trials, increase our costs and adversely impact our financial results
5. 27We may conduct clinical trials for any future product candidates, in whole or in part, outside of the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials, which would likely result in additional costs to us and delay our business plan

Risks Related to Intellectual Property, Generic Competition and Paragraph IV Litigation

1. 28Generic drug approvals and successful challenges against the validity of our patents may cause us to lose exclusivity of some of our products
2. 29Enforcing our proprietary rights is difficult and costly and we may be unable to ensure their protection
3. 30Additionally, some of our products, including Accutane, Targadox and Exelderm, do not have patent protection because they are not eligible or qualify for such protection. This creates greater risk of competition with generic drug manufacturers and may otherwise adversely affect our business or result of operations
4. 31If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business
5. 32Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 33We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
7. 34We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
8. 35If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, or if we breach an agreement under which we license rights to any product or future product candidate, we could lose rights that are important to our business

Risks Related to our Platform and Data

1. 36Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity

Risks Related to Our Finances and Capital Requirements

1. 37We have incurred net losses in recent fiscal years, and we may incur losses for the foreseeable future and may not be able to achieve or maintain profitability
2. 38We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate any future product development programs or commercialization, manufacturing and/or sales efforts
3. 39Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies, but we currently have no commitments or agreements relating to any of these types of transactions
4. 40Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights

Risks Related to Owning our Common Stock

1. 41If we fail to maintain or implement effective internal controls, we may not be able to report financial results accurately or on a timely basis, or to detect fraud, which could have a material adverse effect on our business and the per share price of our common stock
2. 42Our charter documents and Delaware law could discourage takeover attempts and other corporate governance changes
3. 43The requirements of being a public company may strain our resources, divert our management’s attention and affect our ability to attract and retain qualified board members
4. 44Reduced reporting and disclosure requirements applicable to us as an EGC could make our common stock less attractive to investors
5. 45Our shares of common stock are subject to potential delisting if we do not continue to maintain the listing requirements of Nasdaq
6. 46Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains
7. 47The trading price of the shares of our common stock is likely to be volatile, and purchasers of our common stock could incur substantial losses

Risks Related to our Relationship with Fortress Biotech, Inc

1. 48Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders
2. 49We are a “controlled company” within the meaning of Nasdaq listing standards and, as a result, qualify for exemptions from certain corporate governance requirements. Although we do not presently intend to take advantage of these exemptions, we may do so in the future
3. 50We may have received better terms from unaffiliated third parties than the terms we receive in our arrangements with Fortress
4. 51The ownership by our executive officers and some of our directors of shares of equity securities of Fortress and/or rights to acquire equity securities of Fortress might create, or appear to create, conflicts of interest
5. 52Fortress’ current or future financial obligations and arrangements, or an event of default thereon, may change the ownership dynamic of us by Fortress

General Risks

1. 53Failure to manage our growth effectively could cause our business to suffer and have an adverse effect on our business, operating results and financial condition
2. 54If securities or industry analysts do not publish research or reports about our business, or publish inaccurate or unfavorable research reports about our business, our share price and trading volume could decline
3. 55Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the United States. If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our results of operations could be adversely affected
4. 56Global and national financial events may have an impact on our business and financial condition in ways that we currently cannot predict
5. 57If our estimates or judgments relating to our critical accounting policies are erroneous or based on assumptions that change or prove to be incorrect, our operating results could fall below the expectations of securities analysts and investors, resulting in a decline in our stock price
6. 58Changes 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