Liquidia (LQDA) risk factors, FY2025 10-K

Liquidia's FY2025 10-K, filed Mar 05, 2026, lists 55 risk factors in 8 groups. Against the prior year's 54: 8 new, 7 dropped, 24 substantially reworded.

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Risk factors listed
558 groups
New this year
8vs 54 last year
Dropped
7since the prior 10-K
Substantially reworded
24of those kept
Section length
37k wordsItem 1A

What the changes say

  • YUTREPIA was FDA-approved in May 2025 and commercialized in June, shifting risk toward launch execution and uncertain demand.
  • 2025 losses fell to $68.9 million, but accumulated deficit reached $626.3 million and sustained positive cash flow remains uncertain.
  • United Therapeutics litigation now specifically raises possible injunction, FDA withdrawal, or marketing restrictions for YUTREPIA.

What changed since the prior 10-K

New

  • NewRisks Related to our Financial Position and Need for Additional Capital

    We have a history of losses and our ability to sustain profitability in the future remains uncertain

    Despite recent profitable quarters, Liquidia reported a $68.9 million 2025 net loss and $626.3 million accumulated deficit, with YUTREPIA cash flows uncertain.

  • NewRisks Related to our Financial Position and Need for Additional Capital

    Our management has broad discretion in using our available capital and may not use it effectively

    Management controls capital for YUTREPIA, Treprostinil Injection, L606, and corporate needs, but ineffective spending could reduce value and funds available for HCR.

  • NewRisks Related to our Financial Position and Need for Additional Capital

    We are a biopharmaceutical company with only one approved product that was only recently approved by the FDA, which may make it difficult for you to evaluate our business, financial condition and prospects

    YUTREPIA is Liquidia’s only approved product, approved in May 2025 and commercialized in June, leaving little commercial history to assess future revenue.

  • NewRisks Related to our Financial Position and Need for Additional Capital

    Arrangements with healthcare providers, physicians, third-party payors and customers, and our sales, marketing and educational activities, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships

    Healthcare-provider relationships, promotion, pricing, reimbursement, and sales activities for YUTREPIA and Treprostinil Injection could trigger fraud, abuse, and other healthcare-law violations.

  • NewRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    There are risks involved with expanding and maintaining our sales, marketing, and other commercialization capabilities. For example, recruiting and training a commercial field force is expensive and time-consuming

    Liquidia may struggle to recruit, train, retain, and supervise a sufficiently effective commercial field force for its products.

  • NewRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    Forecasting and accounting for YUTREPIA product sales requires us to make numerous assumptions and, if our estimates are inaccurate, our business may be harmed and our share price may be adversely affected

    Inaccurate YUTREPIA demand and revenue forecasts could cause financial harm because estimates depend on market size, adoption, pricing, reimbursement, competition, and free programs.

  • NewRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    Continuing product development requires additional and extensive clinical testing. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements

    Additional indications for YUTREPIA and candidates such as L606 require costly, lengthy clinical trials that can fail or face enrollment, safety, dosing, or monitoring delays.

  • NewRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    Interim, “top-line,” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data

    Interim or preliminary trial results may change materially after additional patient data, audits, verification, or more complete analysis.

Dropped

  • DroppedRisks Related to our Financial Position and Need for Additional Capital

    We 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

    Substantial doubt about continuing as a going concern from historical losses and negative operating cash flows.

  • DroppedRisks Related to our Financial Position and Need for Additional Capital

    Our 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

  • DroppedRisks Related to our Financial Position and Need for Additional Capital

    We 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

    Potential misuse of HCR financing and prior equity proceeds for development, commercialization, and other specified activities.

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

    We 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

  • DroppedRisks Related to the Development and Regulatory Approval of our Product Candidates

    Any 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

  • DroppedRisks Related to Our Dependence on Third Parties

    We 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

  • DroppedRisks Related to our Common Stock

    Because 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

    Difficulty evaluating a late-stage company with no approved products or historical revenue from its own products.

Reworded

  • 85% rewrittenRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    United Therapeutics may in the future seek to assert additional or newly issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin us from selling YUTREPIA for one or more indications through one or more additional legal proceedings

    The risk now specifically identifies the ’327 Patent and possible injunctions, FDA withdrawal of YUTREPIA approval, or restrictions on either indication.

    Was: In 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

  • 85% rewrittenRisks Related to the Manufacturing of our Products and Product Candidates

    L606 is based on 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

    The focus narrowed from both PRINT and liposomal technologies to Pharmosa’s liposomal technology and added challenges scaling L606 manufacturing for clinical supply.

    Was: Our 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

  • 83% rewrittenRisks Related to our Financial Position and Need for Additional Capital

    Our ability to use our net operating loss carry forwards and research and development tax credits may be limited

    Liquidia determined that a prior ownership change occurred, so Section 382 annually limits use of part of its NOLs and tax attributes.

    Was: Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited

  • 77% rewrittenRisks Related to Our Dependence on Third Parties

    We rely on third parties to conduct our preclinical studies and clinical trials

    No substantive change is shown in the provided text; the risk remains CRO noncompliance making clinical data unreliable.

  • 70% rewrittenRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    We may not be able to scale or maintain our commercial operation, including scaling and maintaining marketing and sales capabilities or entering into agreements with third parties to market and sell our drug products

    The discussion now reflects actual YUTREPIA commercialization and emphasizes retaining and scaling the commercial field force amid recruiting competition.

    Was: We 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

  • 67% rewrittenRisks Related to Government Regulation

    Environmental, social and governance matters may impact our business and reputation

    The ESG discussion now notes that regulatory changes have scaled back or halted proposed or enacted ESG requirements.

  • 67% rewrittenRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    We may not be able to commence or complete clinical trials for our products and product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials

    The wording now covers products as well as product candidates and related safety and efficacy data during trial enrollment.

    Was: We 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

  • 59% rewrittenRisks Related to our Financial Position and Need for Additional Capital

    Liquidia 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 their FDA and healthcare compliance relative to Treprostinil Injection

    The heading now emphasizes broader dependence on Sandoz’s FDA and healthcare compliance, while the underlying dependence on its ANDA remains.

    Was: Liquidia 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

  • 57% rewrittenRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    Our business and operations may be adversely affected by the effects of public health emergencies, including pandemics and epidemics

  • 50% rewrittenRisks Related to our Financial Position and Need for Additional Capital

    Medical devices, which we do not control, are necessary for the administration of YUTREPIA, L606 and Treprostinil Injection

  • 48% rewrittenRisks Related to our Common Stock

    As 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

  • 47% rewrittenRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    In addition, United Therapeutics may seek to assert other issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin the continued commercialization of YUTREPIA

    Was: In 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

  • 46% rewrittenRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects

  • 44% rewrittenRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    The 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 the United States may directly affect us and the global economy

    Was: The 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

  • 40% rewrittenRisks Related to the Manufacturing of our Products and Product Candidates

    We 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

  • 38% rewrittenRisks Related to the Commercialization of our Products, Product Candidates and Generic Treprostinil Injection

    If 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

  • 36% rewrittenRisks Related to our Financial Position and Need for Additional Capital

    Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition

  • 32% rewrittenRisks Related to our Intellectual Property

    We may be subject to claims from third parties that our products infringe their intellectual property rights

  • 32% rewrittenRisks Related to Government Regulation

    Recently enacted and future legislation and other 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

    Was: Recently 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

  • 31% rewrittenRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our products and product candidates may be subject to multiple rounds of review or may not receive marketing approval

    Was: The 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

  • 30% rewrittenRisks Related to our Common Stock

    We expect that the market price of our common stock may be volatile, and you may lose all or part of your investment

  • 30% rewrittenRisks Related to the Development and Regulatory Approval of our Products and Product Candidates

    Products and product 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

    Was: Product 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

  • 26% rewrittenRisks Related to our Common Stock

    Future sales of our common stock or securities convertible into our common stock in the public market could cause our stock price to fall

  • 20% rewrittenRisks Related to our Intellectual Property

    Our commercial success depends largely on our ability to protect our intellectual property

All 55 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Financial Position and Need for Additional Capital

  1. 01We have a history of losses and our ability to sustain profitability in the future remains uncertainNew
  2. 02Our financing facility with 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 our available capital and may not use it effectivelyNew
  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 research and development tax credits may be limited83% rewritten
  6. 06Changes to existing tax laws, or challenges to our tax positions could adversely affect our business and financial condition36% rewritten
  7. 07We are a biopharmaceutical company with only one approved product that was only recently approved by the FDA, which may make it difficult for you to evaluate our business, financial condition and prospectsNew
  8. 08Arrangements with healthcare providers, physicians, third-party payors and customers, and our sales, marketing and educational activities, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationshipsNew
  9. 09Medical devices, which we do not control, are necessary for the administration of YUTREPIA, L606 and Treprostinil Injection50% rewritten
  10. 10Liquidia 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 their FDA and healthcare compliance relative to Treprostinil Injection59% rewritten
  11. 11We maintain our cash at financial institutions, often in balances that exceed federally insured limits

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

  1. 12United Therapeutics may in the future seek to assert additional or newly issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin us from selling YUTREPIA for one or more indications through one or more additional legal proceedings85% rewritten
  2. 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 affected38% rewritten
  3. 14Our products may not achieve market acceptance or adequate third-party payor coverage
  4. 15We may not be able to scale or maintain our commercial operation, including scaling and maintaining marketing and sales capabilities or entering into agreements with third parties to market and sell our drug products70% rewritten
  5. 16There are risks involved with expanding and maintaining our sales, marketing, and other commercialization capabilities. For example, recruiting and training a commercial field force is expensive and time-consumingNew
  6. 17Forecasting and accounting for YUTREPIA product sales requires us to make numerous assumptions and, if our estimates are inaccurate, our business may be harmed and our share price may be adversely affectedNew
  7. 18We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance
  8. 19Our business and operations may be adversely affected by the effects of public health emergencies, including pandemics and epidemics57% rewritten
  9. 20The 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 the United States may directly affect us and the global economy44% rewritten

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

  1. 21Continuing product development requires additional and extensive clinical testing. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirementsNew
  2. 22Interim, “top-line,” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final dataNew
  3. 23The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our products and product candidates may be subject to multiple rounds of review or may not receive marketing approval31% rewritten
  4. 24We may not be able to commence or complete clinical trials for our products and product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials67% rewritten
  5. 25Products and product 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 process30% rewritten
  6. 26In addition, United Therapeutics may seek to assert other issued patents against us, including U.S. Patent Number 11,723,887, and may seek to enjoin the continued commercialization of YUTREPIA47% rewritten
  7. 27We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects46% rewritten
  8. 28We 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
  9. 29Even with regulatory approval for YUTREPIA, our products and business remain subject to ongoing regulatory obligations and review
  10. 30Even with approval of YUTREPIA in the United States and even if we obtain marketing approval for our other product candidates in the United States, we or our collaborators may not obtain marketing approval for YUTREPIA or our other product candidates elsewhere

Risks Related to Government Regulation

  1. 31Recently enacted and future legislation and other 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 obtain32% rewritten
  2. 32Environmental, social and governance matters may impact our business and reputation67% rewritten
  3. 33Climate 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. 34We rely on third parties to conduct our preclinical studies and clinical trials77% rewritten
  2. 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
  3. 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 rights32% rewritten
  2. 38Our commercial success depends largely on our ability to protect our intellectual property20% rewritten
  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, to enforce our intellectual property rights or to defend against claims of intellectual property infringement by third parties, 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 Products and Product Candidates

  1. 45We 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 demand40% rewritten
  2. 46L606 is based on 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 approval85% rewritten
  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 fall26% rewritten
  2. 50We expect that the market price of our common stock may be volatile, and you may lose all or part of your investment30% rewritten
  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 shares48% rewritten
  5. 53Anti-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
  6. 54Because 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
  7. 55An 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

Other Liquidia 10-Ks

  • FY2024 10-K risk factors
    56 risks

    YUTREPIA approval and United Therapeutics patent litigation dominate near-term commercial risk.

    Filed Mar 19, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.