Biolife Solutions (BLFS) risk factors, FY2024 10-K

Biolife Solutions's FY2024 10-K, filed Mar 03, 2025, lists 33 risk factors in 6 groups. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
336 groups
Section length
12k wordsItem 1A

Biolife Solutions's biggest risks in the FY2024 10-K

  • Single-source suppliers manufacture critical bioproduction components for cell and gene therapies.
  • Goodwill and intangible assets total $221.9 million as of December 31, 2024.
  • Casdin Capital, LLC owns 18.6% of outstanding common stock.

The risks most specific to Biolife Solutions

  • Risks related to our business and operations

    If our products or the products of our competitors do not perform as expected or the reliability of the technology on which our products are based is questioned, we could experience lost revenue, delayed or reduced market acceptance of our products, increased costs, and damage to our reputation

    Product defects or unreliability in our bioproduction products could lead to lost revenue and reputational damage among sensitive cell therapy customers.

  • Risks related to our business and operations

    If intangible assets and goodwill become impaired, we may have to take significant charges against earnings

    We carry $221.9 million in goodwill and intangible assets as of December 31, 2024, which may face impairment charges.

  • Risks related to our business and operations

    We depend on outside suppliers for all our manufacturing supplies, parts and components

    We rely on outside and single-source suppliers for all manufacturing supplies, parts, and components for our bioproduction products.

  • Risks related to our business and operations

    Our business may be subject to product liability claims or product recalls, which could be expensive and could result in a diversion of management’s attention

    Our bioproduction products used in cell and gene therapy expose us to costly product liability claims and recalls.

  • Risks related to our business and operations

    Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues

    We manufacture all biopreservation media internally while outsourcing certain thaw and cold chain products, creating complex manufacturing risks.

  • Risks related to our common stock

    A significant percentage of our outstanding common stock is held by one stockholder, and this stockholder therefore has significant influence on us and our corporate actions

    Casdin Capital, LLC holds 18.6% of our common stock as of December 31, 2024, giving them significant influence over corporate actions.

  • Risks related to accounting matters

    The aforementioned material weaknesses did not result in any identified material misstatements to our financial statements, and there were only immaterial changes to previously released financial results

    We must successfully implement remediation plans over time to address existing material weaknesses in our internal controls.

All 33 risk factors

Headings as the filing states them, in filing order.

Risks related to our business and operations

  1. 01If our products or the products of our competitors do not perform as expected or the reliability of the technology on which our products are based is questioned, we could experience lost revenue, delayed or reduced market acceptance of our products, increased costs, and damage to our reputation
  2. 02We operate in a highly competitive industry and if we cannot compete effectively, our business, financial condition and operating results could be materially and adversely affected
  3. 03We expect our operating results to fluctuate significantly from period to period
  4. 04If intangible assets and goodwill become impaired, we may have to take significant charges against earnings
  5. 05We depend on outside suppliers for all our manufacturing supplies, parts and components
  6. 06Our success will depend on our ability to attract and retain key personnel
  7. 07attract such key management personnel and the loss of one or more of these individuals could have a material adverse effect on our business and operating results
  8. 08Our business may be subject to product liability claims or product recalls, which could be expensive and could result in a diversion of management’s attention
  9. 09Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues
  10. 10While we are not currently subject to FDA or other regulatory approvals, if our products become subject to regulatory requirements, the manufacture and sale of our products may be delayed or prevented, or we may become subject to increased expenses
  11. 11Healthcare reform measures could adversely affect our business and financial results
  12. 12Insurance coverage is increasingly difficult to obtain or maintain
  13. 13We are and may become the subject of various claims, litigation or investigations which could have a material adverse effect on our business, financial condition, or results of operations or the price of our common stock
  14. 14Our business and operations could be negatively affected by securities litigation or stockholder activism, which could impact the trading price and volatility of our common stock and may constrain capital deployment opportunities and adversely impact our ability to expand our business

Risks related to our acquisition strategy

  1. 15Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies
  2. 16profitable. Our failure to successfully address the foregoing integration risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all

Risks related to our intellectual property and cyber security

  1. 17Our proprietary rights may not adequately protect our technologies and products
  2. 18Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue
  3. 19We may not be able to protect our intellectual property rights throughout the world
  4. 20We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to, or use of, our technology
  5. 21Even if we are granted a patent, in certain circumstances we may be unable protect our rights to, or use of, our technology
  6. 22U.S. patent laws as well as the laws of some foreign jurisdictions provide for provisional rights in published patent applications beginning on the date of publication, including the right to obtain reasonable royalties, if a patent subsequently issues and certain other conditions are met
  7. 23We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

Risks related to our common stock

  1. 24Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses
  2. 25A significant percentage of our outstanding common stock is held by one stockholder, and this stockholder therefore has significant influence on us and our corporate actions
  3. 26We have not paid dividends on our common stock in the past and do not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock
  4. 27Certain provisions in our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws 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
  5. 28Furthermore, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America will be the sole and exclusive forum for the resolution of any complaint asserting a cause of action under the Securities Act

Risks related to accounting matters

  1. 29The aforementioned material weaknesses did not result in any identified material misstatements to our financial statements, and there were only immaterial changes to previously released financial results

Risks related to disruptive events

  1. 30Public health crises have adversely affected, and could in the future adversely affect, our business, financial condition. results of operations and cash flows
  2. 31Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance
  3. 32Global climate change and related legal and regulatory developments could negatively affect our business, financial condition and results of operations
  4. 33Tariffs and other trade policies could have a substantial impact on our business

Other Biolife Solutions 10-Ks

  • FY2025 10-K risk factors
    37 risks7 new3 dropped7 reworded

    Divestitures now create retained liabilities, indemnification, buyer disputes, stranded costs, customer loss, and litigation exposure.

    Filed Feb 26, 2026

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.