Mannkind (MNKD) risk factors, FY2025 10-K

Mannkind's FY2025 10-K, filed Feb 26, 2026, lists 61 risk factors in 4 groups. Against the prior year's 54: 13 new, 6 dropped, 16 substantially reworded.

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Risk factors listed
614 groups
New this year
13vs 54 last year
Dropped
6since the prior 10-K
Substantially reworded
16of those kept
Section length
25k wordsItem 1A

What the changes say

  • Partner United Therapeutics may prioritize its new Tresmi drug over Tyvaso DPI, hurting revenues.
  • Acquisitions like scPharma increased debt, interest expense, and leverage.
  • Tariffs and international supply chain issues threaten manufacturing margins for V-Go and Furoscix components.

What changed since the prior 10-K

New

  • NewRISKS RELATED TO OUR BUSINESS

    If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materially

    United Therapeutics highlighted Tresmi as a category killer to rival dry-powder inhalers, potentially reducing its commercial emphasis on Tyvaso DPI and our royalties.

  • NewRISKS RELATED TO OUR BUSINESS

    our control, and we cannot predict how evolving market dynamics, product differentiation claims, or United Therapeutics’ internal assessments will influence its promotional and development strategies

    Shifting promotional strategies or competitive products introduced by United Therapeutics could reduce Tyvaso DPI sales and adversely affect our operations.

  • NewRISKS RELATED TO OUR BUSINESS

    These risks may be exacerbated by our limited experience with V-Go and its manufacturing processes. If V-Go does not continue to qualify for duty-free treatment, any tariffs that apply to imported goods from China could materially and adversely affect our margins on V-Go sales

    Tariffs on imported goods from China could adversely affect V-Go margins, while raw material delays or supplier non-compliance could disrupt Furoscix and Afrezza production.

  • NewRISKS RELATED TO OUR BUSINESS

    Components made domestically from imported materials that are or become subject to tariffs would be expected to become more expensive in the future. These and any future tariffs will increase our cost of goods and decrease our operating margins

    Components made from imported materials subject to tariffs will increase our cost of goods, and finding new FDA-compliant suppliers requires significant time and expense.

  • NewRISKS RELATED TO OUR BUSINESS

    International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects

    International trade policies, tariffs, and U.S.-China trade relations present material risks to our global supply chain for raw materials, chemical components, and specialized equipment.

  • NewRISKS RELATED TO OUR BUSINESS

    The Blackstone Credit Facility contains restrictive covenants that may materially limit our operating flexibility. A default under the instruments governing our indebtedness, including the Blackstone Credit Facility, could materially and adversely affect our financial position

    The Blackstone Credit Facility imposes restrictive covenants that limit our operating flexibility, asset disposals, debt incurrence, and dividend payments.

  • NewRISKS RELATED TO OUR BUSINESS

    engage in transactions with our affiliates

    The Blackstone Credit Facility requires us to maintain at least $40.0 million in liquidity and secures substantially all our assets, creating default risks if breached.

  • NewRISKS RELATED TO OUR BUSINESS

    Our products, product candidates and technology may not be able to compete effectively or may be rendered obsolete

    United Therapeutics' Tresmi soft mist inhaler and other rapid scientific developments could render our Technosphere powders and FDKP technology obsolete.

  • NewRISKS RELATED TO GOVERNMENT REGULATION

    Healthcare legislation may impact the net sales of commercial products sold by us or any partner

    The One Big Beautiful Bill Act narrowed PPACA exchange enrollment and reduced Medicaid spending, potentially decreasing Americans with health insurance.

  • NewRISKS RELATED TO GOVERNMENT REGULATION

    on our ability to commercialize our products and product candidates under development, our business, financial condition and profitability may be adversely affected

    The IRA and other healthcare reforms create downward pricing pressure and stricter coverage criteria, risking our future revenues.

  • NewRISKS RELATED TO GOVERNMENT REGULATION

    (defined to include defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members

    HIPAA and HITECH impose strict requirements regarding the privacy, security, and transmission of individually identifiable health information.

  • NewRISKS RELATED TO INTELLECTUAL PROPERTY

    will be subjected to further proceedings limiting their scope, will provide significant proprietary protection or competitive advantage, or will be circumvented or invalidated

    Our pending patent applications and issued patents may face disputes, or be circumvented or invalidated under the first inventor to file system.

  • NewRISKS RELATED TO OUR COMMON STOCK

    amended and restated bylaws. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions

Dropped

  • DroppedRISKS RELATED TO OUR BUSINESS

    These risks may be exacerbated by our limited experience with V-Go and its manufacturing processes

  • DroppedRISKS RELATED TO OUR BUSINESS

    Our products and product candidates may be rendered obsolete by rapid technological change

  • DroppedRISKS RELATED TO GOVERNMENT REGULATION

    Healthcare legislation may make it more difficult to receive revenues

  • DroppedRISKS RELATED TO GOVERNMENT REGULATION

    Our business could be negatively impacted by environmental, social and corporate governance ("ESG") matters or our reporting of such matters

  • DroppedRISKS RELATED TO GOVERNMENT REGULATION

    Our portfolio of investment securities may require us to register with the SEC as an “investment company” in accordance with the Investment Company Act of 1940 (“‘40 Act”)

  • DroppedRISKS RELATED TO OUR COMMON STOCK

    If we fail to continue to meet all applicable listing requirements, our common stock may be delisted from the Nasdaq Global Market, which could have an adverse impact on the liquidity and market price of our common stock

    Risks from limited experience with V-Go manufacturing and third-party supplier failures.

Reworded

  • 88% rewrittenRISKS RELATED TO GOVERNMENT REGULATION

    If we or any partner fails to comply with federal and state healthcare laws, including fraud and abuse and health information laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected

    Updated to refine federal and state healthcare law compliance language.

  • 72% rewrittenRISKS RELATED TO INTELLECTUAL PROPERTY

    If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably

    Updated to clarify proprietary rights protection and intellectual property enforcement costs.

  • 72% rewrittenRISKS RELATED TO OUR BUSINESS

    Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations

    Added specific tax law impacts including the OBBBA and the Tax Cuts and Jobs Act capitalization of R&E expenditures over five and fifteen years.

  • 46% rewrittenRISKS RELATED TO OUR BUSINESS

    possible write-offs or impairment charges relating to acquired assets, businesses or joint ventures

    Added specific risks from the scPharma acquisition paid in cash, which increased net debt, interest expense, and leverage.

  • 43% rewrittenRISKS RELATED TO OUR COMMON STOCK

    Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price

    Added currency fluctuations and actual or anticipated bank failures to general market, economic, and geopolitical disruption risks.

  • 42% rewrittenRISKS RELATED TO GOVERNMENT REGULATION

    product sales and distribution

    Refined wording regarding foreign regulatory approval processes and price approvals.

  • 42% rewrittenRISKS RELATED TO OUR COMMON STOCK

    any action asserting a claim against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine

    Refined internal affairs doctrine and federal district forum selection language for Securities Act claims.

  • 33% rewrittenRISKS RELATED TO OUR BUSINESS

    Manufacturing risks may adversely affect our ability to manufacture our products and Tyvaso DPI, which could reduce our gross margin and profitability

    Clarified manufacturing details for Afrezza and Tyvaso DPI at the Danbury facility and updated contract packager usage.

  • 26% rewrittenRISKS RELATED TO OUR BUSINESS

    Our ability to use net operating loss carryforwards to offset future taxable income may be subject to limitations

  • 26% rewrittenRISKS RELATED TO OUR BUSINESS

    In order to increase adoption and sales of our products, we need to continue to develop our commercial organization, including maintaining and growing a highly experienced and skilled workforce with qualified sales representatives

  • 26% rewrittenRISKS RELATED TO OUR COMMON STOCK

    Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event

  • 25% rewrittenRISKS RELATED TO OUR COMMON STOCK

    Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations

  • 25% rewrittenRISKS RELATED TO OUR BUSINESS

    We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire

    Was: We may not realize the anticipated benefits of any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we may acquire

  • 25% rewrittenRISKS RELATED TO OUR BUSINESS

    If third-party payers do not cover our approved products, such products might not be prescribed, used or purchased, which would adversely affect our revenues

  • 25% rewrittenRISKS RELATED TO OUR COMMON STOCK

    Our stock price is volatile

  • 22% rewrittenRISKS RELATED TO OUR COMMON STOCK

    Because we do not expect to pay dividends in the foreseeable future, you must rely on stock appreciation for any return on any investment in our common stock

All 61 risk factors

Headings as the filing states them, in filing order.

RISKS RELATED TO OUR BUSINESS

  1. 01The products that we or our collaboration partner are commercializing may only achieve a limited degree of commercial success
  2. 02marketing and distribution support
  3. 03If United Therapeutics reduces its commercial emphasis on Tyvaso DPI, our revenues could decline materiallyNew
  4. 04our control, and we cannot predict how evolving market dynamics, product differentiation claims, or United Therapeutics’ internal assessments will influence its promotional and development strategiesNew
  5. 05In order to increase adoption and sales of our products, we need to continue to develop our commercial organization, including maintaining and growing a highly experienced and skilled workforce with qualified sales representatives26% rewritten
  6. 06unforeseen delays, costs and expenses associated with maintaining our sales organization
  7. 07Manufacturing risks may adversely affect our ability to manufacture our products and Tyvaso DPI, which could reduce our gross margin and profitability33% rewritten
  8. 08These risks may be exacerbated by our limited experience with V-Go and its manufacturing processes. If V-Go does not continue to qualify for duty-free treatment, any tariffs that apply to imported goods from China could materially and adversely affect our margins on V-Go salesNew
  9. 09Components made domestically from imported materials that are or become subject to tariffs would be expected to become more expensive in the future. These and any future tariffs will increase our cost of goods and decrease our operating marginsNew
  10. 10International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
  11. 11If third-party payers do not cover our approved products, such products might not be prescribed, used or purchased, which would adversely affect our revenues25% rewritten
  12. 12We may not realize the anticipated benefits of the scPharma acquisition or any future acquisition or strategic transaction; we may be unable to successfully integrate new products, technologies or businesses we acquire25% rewritten
  13. 13possible write-offs or impairment charges relating to acquired assets, businesses or joint ventures46% rewritten
  14. 14We may need to raise additional capital to fund our operations
  15. 15the costs of discontinuing projects and technologies, and/or decommissioning existing facilities, if we undertake any such activities
  16. 16We expect that our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period
  17. 17The Blackstone Credit Facility contains restrictive covenants that may materially limit our operating flexibility. A default under the instruments governing our indebtedness, including the Blackstone Credit Facility, could materially and adversely affect our financial positionNew
  18. 18engage in transactions with our affiliatesNew
  19. 19We may incur losses and may not generate positive or sufficient cash flow from operations in the future which may have an adverse impact on our working capital, total assets and stockholders' equity and our ability to service all of our indebtedness and commitments
  20. 20as a result of general disruptions in the operations of payers, distributors, logistics providers and other third parties that are necessary for our products to be prescribed and reimbursed
  21. 21Continued testing of our products and product candidates may not yield successful results, and even if it does, we may still be unable to successfully commercialize our current or future products
  22. 22disruptions caused by geopolitical conflicts, man-made or natural disasters or public health pandemics or epidemics or other business interruptions
  23. 23If we do not achieve our projected development goals in the timeframes we expect, our business, financial condition and results of operations will be harmed and the market price of our common stock and other securities could decline
  24. 24The long-term safety and efficacy of approved products may differ from clinical studies, which could negatively impact sales and could lead to reputational harm or other negative effects
  25. 25Our products, product candidates and technology may not be able to compete effectively or may be rendered obsoleteNew
  26. 26Reports of side effects or safety concerns in related technology fields or in other companies’ clinical studies could delay or prevent us from obtaining regulatory approval for our product candidates or negatively impact public perception of our approved products
  27. 27If product liability claims are brought against us, we may incur significant liabilities and suffer damage to our reputation
  28. 28If we lose any key employees, our operations and our ability to execute our business strategy could be materially harmed
  29. 29If our internal controls over financial reporting are not considered effective, our business, financial condition and market price of our common stock and other securities could be adversely affected
  30. 30Changes or modifications in financial accounting standards may harm our results of operations
  31. 31Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations72% rewritten
  32. 32Our ability to use net operating loss carryforwards to offset future taxable income may be subject to limitations26% rewritten
  33. 33Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
  34. 34We may undertake internal restructuring activities in the future that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition
  35. 35We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business
  36. 36We maintain our cash at financial institutions, often in balances that exceed federally insured limits

RISKS RELATED TO GOVERNMENT REGULATION

  1. 37product sales and distribution42% rewritten
  2. 38Even if we comply with regulatory requirements, we may not be able to obtain the labeling claims necessary or desirable for product promotion. We may also be required to undertake post-marketing studies
  3. 39We are subject to stringent, ongoing government regulation
  4. 40injunctions or the imposition of civil or criminal penalties
  5. 41Healthcare legislation may impact the net sales of commercial products sold by us or any partnerNew
  6. 42on our ability to commercialize our products and product candidates under development, our business, financial condition and profitability may be adversely affectedNew
  7. 43If we or any partner fails to comply with federal and state healthcare laws, including fraud and abuse and health information laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected88% rewritten
  8. 44(defined to include defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family membersNew

RISKS RELATED TO INTELLECTUAL PROPERTY

  1. 45If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably72% rewritten
  2. 46will be subjected to further proceedings limiting their scope, will provide significant proprietary protection or competitive advantage, or will be circumvented or invalidatedNew
  3. 47If we become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, we would be required to devote substantial time and resources to prosecute or defend such proceedings
  4. 48If our technologies conflict with the proprietary rights of others, we may incur substantial costs as a result of litigation or other proceedings and we could face substantial monetary damages and be precluded from commercializing our products, which would materially harm our business and financial condition
  5. 49A patent owner may claim that we are making, using, selling or offering for sale an invention covered by the owner’s patents and may go to court to stop us from engaging in such activities. Such litigation is not uncommon in our industry
  6. 50We may not obtain trademark registrations for our potential trade names

RISKS RELATED TO OUR COMMON STOCK

  1. 51Our stock price is volatile25% rewritten
  2. 52the status of any legal proceedings or regulatory matters against or involving us or any of our executive officers and directors; and
  3. 53Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
  4. 54any action asserting a claim against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine42% rewritten
  5. 55amended and restated bylaws. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictionsNew
  6. 56Because we do not expect to pay dividends in the foreseeable future, you must rely on stock appreciation for any return on any investment in our common stock22% rewritten
  7. 57Future sales of shares of our common stock in the public market, or the perception that such sales may occur, may depress our stock price and adversely impact the market price of our common stock and other securities
  8. 58If other biotechnology and biopharmaceutical companies or the securities markets in general encounter problems, the market price of our common stock and other securities could be adversely affected
  9. 59Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price43% rewritten
  10. 60Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event26% rewritten
  11. 61Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations25% rewritten

Other Mannkind 10-Ks

  • FY2024 10-K risk factors
    54 risks

    Commercializing therapeutic products and relying on the Danbury facility for Afrezza and Tyvaso DPI manufacturing dominate MannKind's risk profile.

    Filed Feb 26, 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.