Liquidia (LQDA) risk factors, 2025 10-K

Risks Related to our Financial Position and Need for Additional Capital

1. 01We have a history of losses and our future profitability remains uncertain. Our net losses and significant cash used in operating activities have raised substantial doubt regarding our ability to continue as a going concern
2. 02Our financing facility with HealthCare Royalty Partners IV, L.P. (“HCR”) contains operating and financial covenants that restrict our business and financing activities, and is subject to acceleration in specified circumstances, which may result in HCR taking possession and disposing of any collateral
3. 03Our management has broad discretion in using the net proceeds from our financing facility with HCR and prior equity offerings and may not use them effectively
4. 04We depend on skilled labor, and our business and prospects may be adversely affected if we lose the services of our skilled personnel, including those in senior management, or are unable to attract new skilled personnel
5. 05Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited
6. 06Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition
7. 07We are a late-stage clinical biopharmaceutical company with no approved products and no historical revenue from the sale of our own products, which may make it difficult for you to evaluate our business, financial condition and prospects
8. 08Liquidia PAH does not hold the FDA regulatory approval for Treprostinil Injection and is dependent on Sandoz to manufacture and supply Treprostinil Injection in compliance with FDA requirements, and is more broadly dependent on Sandoz’s FDA and healthcare compliance relative to Treprostinil Injection
9. 09Medical devices, which we do not control, are necessary for the administration of YUTREPIA, L606 and Treprostinil Injection
10. 10We maintain our cash at financial institutions, often in balances that exceed federally insured limits

Risks Related to the Commercialization of our Product Candidates and Generic Treprostinil Injection

1. 11In addition, United Therapeutics may seek to assert newly issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin the FDA from granting final approval to YUTREPIA or enjoin us from launching YUTREPIA through one or more additional legal proceedings
2. 12We face significant competition from large pharmaceutical companies, among others, in developing our products and in gaining regulatory approval to bring them to market in time to achieve commercial success, and our operating results will suffer if we are unable to compete effectively
3. 13If the FDA or comparable regulatory authorities in other countries approve generic versions of our product candidates, or do not grant our product candidates a sufficient period of market exclusivity before approving their generic versions, our ability to generate revenue may be adversely affected
4. 14introduction of a generic drug product, a significant percentage of the sales of any reference listed drug may be lost to the generic drug product
5. 15Our products may not achieve market acceptance or adequate third-party payor coverage
6. 16We may not be able to build a commercial operation, including establishing and maintaining marketing and sales capabilities or entering into agreements with third parties to market and sell our drug products
7. 17We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance
8. 18Our business and operations may be adversely affected by the effects of public health emergencies, including pandemics and epidemics
9. 19The political and economic environment in the United States could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by a new U.S. presidential administration may directly affect us and the global economy

Risks Related to the Development and Regulatory Approval of our Product Candidates

1. 20The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our product candidates may be subject to multiple rounds of review or may not receive marketing approval
2. 21We may not be able to commence or complete clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials
3. 22Any negative results we may report in clinical trials of our product candidates may also make it difficult or impossible to recruit and retain patients in other clinical trials of that same product candidate
4. 23Product candidates that the FDA deems to be combination products, such as YUTREPIA and L606, or that otherwise rely on innovative drug delivery systems, may face additional challenges, risks and delays in the product development and regulatory approval process
5. 24In addition, United Therapeutics may seek to assert newly issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin the FDA from granting final approval to YUTREPIA or enjoin us from launching YUTREPIA
6. 25We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects
7. 26We have conducted, and may in the future conduct, clinical trials for our product candidates outside the United States and the FDA may not accept data from such trials
8. 27Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review
9. 28Even if we obtain marketing approval for our product candidates in the United States, we or our collaborators may not obtain marketing approval for the same product candidates elsewhere

Risks Related to Government Regulation

1. 29Recently enacted and future legislation and other legal developments may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and product candidates and affect the prices we may obtain
2. 30previously gave judicial deference to administrative action by agencies in the executive branch. Further, the Supreme Court’s decision in Corner Post may result in challenges to FDA decisions by new litigants long into the future, resulting in greater uncertainty about our continued operations
3. 31Environmental, social and governance matters may impact our business and reputation
4. 32Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations, cash flows and prospects

Risks Related to Our Dependence on Third Parties

1. 33We rely on third parties to conduct our preclinical studies and clinical trials
2. 34We depend on third parties for clinical and commercial supplies, including single suppliers for the active ingredient, the device, encapsulation and packaging of YUTREPIA and single suppliers for the active ingredient, the device, bulk product manufacturing and packaging of L606
3. 35If we are unable to establish or maintain licensing and collaboration arrangements with other pharmaceutical companies on acceptable terms, or at all, we may not be able to develop and commercialize additional product candidates using our PRINT technology
4. 36Our collaboration and licensing arrangements may not be successful

Risks Related to our Intellectual Property

1. 37We may be subject to claims from third parties that our products infringe their intellectual property rights
2. 38Our commercial success depends largely on our ability to protect our intellectual property
3. 39Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
4. 40If we are unable to protect our trade secrets, the value of our PRINT technology and product candidates may be negatively impacted, which would have a material and adverse effect on our competitive position and prospects
5. 41We rely on licenses to intellectual property that are owned by third parties
6. 42We may become involved in litigation to protect our intellectual property or enforce our intellectual property rights, which could be expensive, time-consuming and may not be successful
7. 43We may not be able to enforce our intellectual property rights throughout the world
8. 44We need to protect our trademark, trade name and service mark rights to prevent competitors from taking advantage of our name recognition

Risks Related to the Manufacturing of our Product Candidates

1. 45Our product candidates are based on our proprietary, novel technology, which has not been used to manufacture any products that have been previously approved by the FDA, making it difficult to predict the time and cost of development and of subsequently obtaining final regulatory approval
2. 46We may experience unexpected challenges as we ramp up our manufacturing capacity to meet demand or during commercial manufacturing, which may result in our inability to supply sufficient quantities of product to meet demand
3. 47Our facilities are subject to extensive and ongoing regulatory requirements and failure to comply with these regulations may result in significant liability
4. 48Our operations are concentrated in Morrisville, North Carolina and interruptions affecting us or our suppliers due to natural or man-made disasters or other unforeseen events could materially and adversely affect our operations and result in losses that may not be covered by insurance

Risks Related to our Common Stock

1. 49Future sales of our common stock or securities convertible into our common stock in the public market could cause our stock price to fall
2. 50We expect that the market price of our common stock may be volatile, and you may lose all or part of your investment
3. 51Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval
4. 52As a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to do so may adversely affect investor confidence in us and, as a result, the trading price of our shares
5. 53Because we are a “smaller reporting company,” we may take advantage of certain scaled disclosures available to us, resulting in holders of our securities receiving less Company information than they would receive from a public company that is not a smaller reporting company
6. 54Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us difficult, limit attempts by our stockholders to replace or remove our current management and adversely affect our stock price
7. 55Because 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 gain
8. 56An impairment of our long-lived contract acquisition costs and intangible assets, including goodwill, could have a material non-cash adverse impact on our results of operations