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BLFS

BIOLIFE SOLUTIONS INC
NASDAQ · HEALTH CARE · ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS
No price history available

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How BLFS rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
63%
of sentences unchanged
Added
136
new sentences
Dropped
99
sentences removed
Length
+1,369
words, now 18,807

New in FY2025

  • If we lose any of these large customers or if there are disruptions in the sales of these products, our net product revenue and operating results could decline significantly. • We expect our operating results to fluctuate significantly from period to period. • If intangible assets and goodwill become impaired, we may have to take significant charges against earnings. • Our success will depend on our ability to attract and retain key personnel. • 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. • Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues. • We are dependent on our suppliers and third-party manufacturers, including single-source and sole-source suppliers, and disruptions in our supply chain could adversely affect our ability to manufacture and deliver products. • While 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. • We and our customers are subject to various international governmental regulations.
  • Compliance with or changes in such regulations may cause us to incur significant expenses, and if we fail to maintain satisfactory compliance with certain regulations, we may be forced to recall products and cease their manufacture and distribution, and we could be subject to civil or criminal penalties. • Healthcare reform measures could adversely affect our business and financial results. • Insurance coverage is increasingly difficult to obtain or maintain. • We 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. • Our 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. • Our 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. • Our recent divestitures expose us to ongoing risks and uncertainties, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or stock price. • Our proprietary rights may not adequately protect our technologies and products. • Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue. • We may not be able to protect our intellectual property rights throughout the world. • We 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. • Even if we are granted a patent, in certain circumstances we may be unable to protect our rights to, or use of, our technology. • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties. • Our inability to protect our information systems and networks and the proprietary and confidential information in our possession from continually evolving cybersecurity risks or other technological risks, including as a result of breaches of our associated third parties' information technology systems, could materially adversely impact our business, financial condition and results of operations, in addition to our reputation and relationships with our employees, customers, suppliers and business partners. • The development, deployment and use of artificial intelligence ("AI") technologies present new risks and challenges that could adversely impact our business • Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses. • 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. • We 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. • Certain 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. • Our Amended and Restated Bylaws designate the Court of Chancery of the State of Delaware and U.S. federal district courts as the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which limits our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or other employees. • Though our internal control over financial reporting for the year ended December 31, 2025 was concluded to be operating effectively, we have historically identified material weaknesses in our internal control over financial reporting.
  • We have remediated our historical material weaknesses, though if we are unable to maintain an effective system of internal control over financial reporting or disclosure controls and procedures, we may not be able to accurately and timely report financial results or prevent fraud, and our ability to meet our reporting obligations and the trading price of our common stock could be negatively affected. • Changes in tax laws and regulations, including international tax developments, could adversely affect our financial condition and results of operations. • Our ability to use net operating loss ("NOL") and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), and it is possible that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our NOL and tax credit carryforwards. • Natural 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. • Tariffs and other trade policies could have a substantial impact on our business. • Unfavorable currency exchange rate fluctuations may lead to lower operating margins or may cause us to raise prices for our products and services, which could result in reduced sales. • Public health crises have adversely affected, and could in the future adversely affect, our business, financial condition, results of operations, and cash flows. • Global climate change and related legal and regulatory developments could negatively affect our business, financial condition and results of operations.
  • Our portfolio of tools and services focuses on biopreservation media and cell processing products.
  • Recent divestitures and acquisitions On October 6, 2025, the Company entered into a Limited Liability Company Membership Interest Purchase Agreement (the “SAVSU Purchase Agreement”), by and between the Company and Peli BioThermal LLC, a Delaware limited liability company (“SAVSU Buyer”), for the sale by the Company of all of the issued and outstanding limited liability company membership interests (the “SAVSU Interests”) of SAVSU Cleo Technologies, LLC, a Delaware limited liability company ("SAVSU"), to SAVSU Buyer (the “SAVSU Divestiture”).
  • SAVSU contained our evo cloud connected “smart” shipping container products that provided passive storage and transport for temperature-sensitive biologics and pharmaceuticals.
  • Upon the execution of the SAVSU Purchase Agreement, the SAVSU business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
  • On April 4, 2025, pursuant to a Stock Purchase Agreement (the “PanTHERA Purchase Agreement”), by and among the Company, Casdin Partners Master Fund L.P. and each other person listed on Schedule A thereto (the “PanTHERA Sellers”), 2699979 Alberta LTD., an Alberta corporation and a wholly owned subsidiary of the Company (“PanTHERA Buyer Sub”), PanTHERA CryoSolutions Inc., an Alberta corporation (“PanTHERA”) and Dr.
  • Jason Acker, solely in his capacity as Sellers’ Representative, the Company acquired the remaining 90% of the issued and outstanding shares of common stock of PanTHERA not owned by the Company from the PanTHERA Sellers (the “PanTHERA Transaction”).
  • PanTHERA contains a patented Ice Recrystallization Inhibitor (“IRI”) GEN 2 cryopreservation technology that we expect to ultimately enhance the Company’s core capabilities in biopreservation and within the CGT market upon achievement of commercial viability.
  • On November 14, 2024, the Company entered into a Stock Purchase Agreement (the “CBS Purchase Agreement”), by and among the Company, Standex International Corporation, a Delaware corporation (“CBS Buyer”), and Arctic Solutions, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (doing business as Custom Biogenic Systems, or “CBS”), for the sale by the Company of all of the issued and outstanding shares of common stock (the “CBS Shares”) of CBS to CBS Buyer (the “CBS Divestiture”).
  • CBS contained our LN2 cryogenic freezers and other accessory products utilizing a dry storage method.
  • On November 12, 2024, the Company entered into a Stock Purchase Agreement (the “SciSafe Purchase Agreement”), by and among the Company, Subzero Purchaser Corp., a Delaware corporation (“SciSafe Buyer”), SciSafe, Inc., a Delaware corporation and an indirect, wholly owned subsidiary of the Company (“Seller”), and SciSafe, Inc., a New Jersey corporation and an indirect wholly owned subsidiary of the Company (“SciSafe”), for the sale by Seller of all of the issued and outstanding shares of common stock (the “SciSafe Shares”) of SciSafe to SciSafe Buyer (the “SciSafe Divestiture”).
  • SciSafe contained our biological and pharmaceutical storage and cold chain logistics services.
  • On April 17, 2024, the Company sold all of the issued and outstanding shares of common stock of Global Cooling, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Global Cooling”), to GCI Holdings Company, LLC, an Ohio limited liability company (“GCI Holdings”) pursuant to a Stock Purchase Agreement, dated April 17, 2024 (the “Global Cooling Purchase Agreement”), by and between the Company and GCI Holdings (the “Global Cooling Divestiture”).
  • Global Cooling contained our portfolio of ultra-low temperature freezers.
  • The Company is presenting SAVSU, CBS, SciSafe, and Global Cooling within this Annual Report as discontinued operations for all periods presented within the Consolidated Balance Sheets and Consolidated Statements of Operations.
  • Our products Our bioproduction products and services are comprised of one revenue line that contains three main offerings: • Cell processing and other products ◦ Biopreservation media ◦ Human platelet lysate media (“hPL”), cryogenic and ultralow temperature containers, and automated cell-processing fill machines ◦ Automated thawing devices Cell processing Biopreservation media Our proprietary biopreservation media products, HypoThermosol ® FRS and CryoStor ® Freeze Media, are formulated to mitigate preservation-induced, delayed-onset cell damage and death which result when cells and tissues are subjected to reduced temperatures.
  • Human platelet lysate media, cryogenic vials and automated cell-processing fill machines Our bioproduction products portfolio includes human platelet lysates for cell expansion, which reduces risk and improves downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal ® closed systems that are purpose-built rigid containers used in CGT that can be filled manually or with high throughput systems, CryoCase™ cryo-compatible transparent rigid containers designed for closed-system fill and retrieval, and automated cell processing machines that bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination.
  • According to the Alliance for Regenerative Medicine (“ARM”), “2026 State of the Industry Briefing” there were over 1,900 ongoing clinical trials globally utilizing regenerative medicine at year-end 2025.
  • Additionally, ARM reported an expected $2.0 billion in revenues over the next five years from recently developed and FDA approved CGT therapies, with continued investment in CGT development from the world's largest biopharma companies throughout 2025.
  • ARM also reported there was approximately $11.1 billion invested in the regenerative medicine market in 2025, with an expectation of continued regulatory approvals for CGTs during 2026.
  • We believe we are well positioned to address many of the unique manufacturing challenges in the process of delivering CGTs.
  • We offer products that integrate into the critical steps of preservation and thawing under controlled conditions.
  • Our products are also marketed and distributed by regional distributors under non-exclusive agreements.
  • In 2025, 2024, and 2023, sales to third-party distributors accounted for 34%, 34%, and 38% of our revenue, respectively.
  • The following table represents the Company’s total revenue by geographic area (based on the location of the customer): Years Ended December 31, Revenue by customers’ geographic locations 2025 2024 2023 United States 80 % 75 % 81 % Europe, Middle East, Africa (EMEA) 14 % 19 % 12 % Other 6 % 6 % 7 % Total revenue 100 % 100 % 100 % Manufacturing Cell processing – We maintain and operate two independent cGMP clean room production suites for manufacturing sterile biopreservation media products in Bothell, Washington.
  • Our QMS in Indianapolis is certified to the ISO 9001:2015 standard.
  • Pursuant to our customer and quality agreements, we are required to notify customers of any changes to our raw materials.
  • Thaw systems – Our ThawSTAR automated, water-free thawing products are produced by a contract manufacturing organization ("CMO") based in the United States.
  • Product regulatory status Our products are not subject to any specific FDA or other international marketing regulations for drugs, devices, or biologics.
  • To assist customers with their regulatory applications, we maintain Type II Master Files at the FDA for CryoStor, HypoThermosol FRS, BloodStor 27, Stemulate, nLiven PR, T-Liven PR, CellSeal Closed System containers, and our Cell Thawing Media products, which provide the FDA with information regarding our manufacturing facility and process, our quality system, stability and safety, and any additional testing that has been performed.
  • Despite these precautions, it may be possible for unauthorized third parties to copy certain aspects of our products and/or to obtain and use information that we regard as proprietary (see Part I, “Item 1A.
  • Risk Factors” in this Annual Report for additional details).
  • Issued Patents Patents Applied For Registered Trademarks Cell processing and other products 87 83 45 Competition Our bioproduction products and services compete on the basis of value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies.
  • As of December 31, 2025, we had 155 full-time team members and no part-time team members.
  • Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act, are available free of charge on our website as soon as reasonably practicable after we electronically file such reports with, or furnish those reports to, the Securities and Exchange Commission (the “SEC”).
  • You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report, including our financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding to invest in our common stock.
  • Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations or financial condition.

and 96 more.

Gone since FY2024

  • If we lose any of these large customers or if there are disruptions in the sales of these products, our net product revenue and operating results could decline significantly. • We expect our operating results to fluctuate significantly from period to period. • If intangible assets and goodwill become impaired, we may have to take significant charges against earnings. • We depend on outside suppliers for all our manufacturing supplies, parts and components. • Our success will depend on our ability to attract and retain key personnel. • 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. • Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues. • While 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. • We and our customers are subject to various international governmental regulations.
  • Compliance with or changes in such regulations may cause us to incur significant expenses, and if we fail to maintain satisfactory compliance with certain regulations, we may be forced to recall products and cease their manufacture and distribution, and we could be subject to civil or criminal penalties. • Healthcare reform measures could adversely affect our business and financial results. • Insurance coverage is increasingly difficult to obtain or maintain. • We 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. • Our 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. • Our 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. • Our proprietary rights may not adequately protect our technologies and products. • Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue. • We may not be able to protect our intellectual property rights throughout the world. • We 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. • Even if we are granted a patent, in certain circumstances we may be unable protect our rights to, or use of, our technology. • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties. • Our inability to protect our information systems and networks and the proprietary and confidential information in our possession from continually evolving cybersecurity risks or other technological risks, including as a result of breaches of our associated third parties' information technology systems, could materially adversely impact our business, financial condition and results of operations, in addition to our reputation and relationships with our employees, customers, suppliers and business partners. • Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses. • 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. • We 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. • Certain 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. • Our Amended and Restated Bylaws designate the Court of Chancery of the State of Delaware and U.S. federal district courts as the exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which limits our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, or other employees. • We have identified material weaknesses in our internal control over financial reporting, and if our remediation of such material weaknesses is not effective, or if we are unable to develop and maintain an effective system of internal control over financial reporting or disclosure controls and procedures, we may not be able to accurately and timely report financial results or prevent fraud, and our ability to meet our reporting obligations and the trading price of our common stock could be negatively affected. • Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code, and it is possible that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our net operating loss and tax credit carryforwards. • Public health crises have adversely affected, and could in the future adversely affect, our business, financial condition. results of operations and cash flows. • Natural 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. • Global climate change and related legal and regulatory developments could negatively affect our business, financial condition and results of operations. • Tariffs and other trade policies could have a substantial impact on our business.
  • We have a diversified portfolio of tools and services that focuses on biopreservation, cell processing, cold chain management tools, and thawing of biologic materials.
  • Our products Our bioproduction products and services are comprised of two revenue lines that contain four main offerings: • Cell processing ◦ Biopreservation media ◦ Human platelet lysate media (“hPL”), cryogenic vials, and automated cell-processing fill machines • Evo and ThawSTAR devices ◦ Cloud-connected “smart” shipping containers ◦ Automated thawing devices On April 17, 2024, the Company sold all of the issued and outstanding shares of common stock of Global Cooling, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Global Cooling”), to GCI Holdings Company, LLC, an Ohio limited liability company (“GCI Holdings”) pursuant to a Stock Purchase Agreement, dated April 17, 2024 (the “Global Cooling Purchase Agreement”), by and between the Company and GCI Holdings (the “Global Cooling Divestiture”).
  • On November 12, 2024, the Company entered into a Stock Purchase Agreement (the “SciSafe Purchase Agreement”), by and among the Company, Subzero Purchaser Corp., a Delaware corporation (“SciSafe Buyer”), SciSafe, Inc., a Delaware corporation and an indirect, wholly owned subsidiary of the Company (“Seller”), and SciSafe, Inc., a New Jersey corporation and an indirect wholly owned subsidiary of the Company (“SciSafe”), for the sale by Seller of all of the issued and outstanding shares of common stock (the “SciSafe Shares”) of SciSafe to SciSafe Buyer.
  • On November 14, 2024, the Company entered into a Stock Purchase Agreement (the “CBS Purchase Agreement”), by and among the Company, Standex International Corporation, a Delaware corporation (“CBS Buyer”), and Arctic Solutions, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (doing business as Custom Biogenic Systems, or “CBS”), for the sale by the Company of all of the issued and outstanding shares of common stock (the “CBS Shares”) of CBS to CBS Buyer (the “CBS Transaction”).
  • The Company is presenting Global Cooling, SciSafe, and CBS within this Annual Report as discontinued operations for all periods presented within the Consolidated Balance Sheets and Consolidated Statements of Operations.
  • Cell processing Biopreservation media Our proprietary biopreservation media products, HypoThermosol ® FRS and CryoStor ® Freeze Media, are formulated to mitigate preservation-induced, delayed-onset cell damage and death which result when cells and tissues are subjected to reduced temperatures.
  • Human platelet lysate media, cryogenic vials and automated cell-processing fill machines Our bioproduction products portfolio includes human platelet lysates for cell expansion, which reduces risk and improves downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal ® closed system vials that are purpose-built rigid containers used in CGT that can be filled manually or with high throughput systems, CryoCase™ cryo-compatible transparent rigid containers designed for closed-system fill and retrieval, and automated cell processing machines that bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination.
  • Evo and Thaw devices Cloud connected “ smart ” shipping containers We are a leading developer and supplier of next generation cold chain management tools for cell and gene therapies.
  • Our cloud-connected shipping containers and evo.is cloud app allows biologic products to be traced and tracked in real time.
  • Our evo platform consists of rentable cloud-connected shippers that include technologies enabling tracking software to provide customizable, real-time information on geolocation, payload temperature, ambient temperature, tilt of shipper, humidity, altitude, and alerts when a shipper has been opened.
  • The evo Dry Vapor Shipper (“DVS”) is specifically marketed for use with cell and gene therapies.
  • The evo DVS has several design improvements over traditional competing shipping containers, providing benefits such as extended thermal performance, reduced liquid nitrogen recharge time, improved payload extractors, and the ability to maintain temperature for longer periods if the shipper is tilted on its side.
  • We partner with couriers with established logistic channels and distribution centers.
  • This strategy greatly reduces the time and resource requirements associated with establishing our own logistics services, such as acquiring and maintaining fleets of delivery vehicles and building specialized facilities around the world.
  • Partnerships with multiple white glove couriers allow us to scale our sales and marketing efforts by leveraging couriers' existing channel relationships, as well as the ongoing efforts of their sales and service teams.
  • Courier partners provide promotional efforts by marketing our evo platform to their existing cell and gene therapy customers as a cost-effective and innovative solution.
  • According to the Alliance for Regenerative Medicine (“ARM”), “2025 State of the Industry Briefing” there were over 1,900 ongoing clinical trials utilizing regenerative medicine at year-end 2024 in addition to nine FDA approved CGT therapies, with continued growth in CGT development companies throughout 2024.
  • ARM also reported there was approximately $15.2 billion invested in the regenerative medicine market in 2024, with an expectation of continued regulatory approvals for cell and gene therapies during 2025.
  • We believe we are well positioned to address many of the unique manufacturing challenges in the process of delivering cell and gene therapies.
  • We offer products that integrate into the critical steps of preservation, thawing, and transportable storage under controlled conditions.
  • We have expanded our global commercial organization over time to continue building relationships within the broader CGT market.
  • Our products are also marketed and distributed by STEMCELL Technologies, VWR, and other regional distributors under non-exclusive agreements.
  • In 2024, 2023, and 2022, sales to third-party distributors accounted for 35%, 44%, and 42% of our revenue, respectively.
  • The following table represents the Company’s total revenue by geographic area (based on the location of the customer): Years Ended December 31, Revenue by customers’ geographic locations (1) 2024 2023 2022 United States 75 % 82 % 82 % Europe, Middle East, Africa (EMEA) 19 % 12 % 12 % Other 6 % 6 % 6 % Total revenue 100 % 100 % 100 % (1) As of the year ended December 31, 2023, the Company updated its methodology for determining the country of origin for its sales.
  • Sales are now recorded by shipping country rather than billing country.
  • The Company updated the methodology retrospectively, adjusting the prior year presentation for all regions presented.
  • Manufacturing Cell processing – We maintain and operate two independent cGMP clean room production suites for manufacturing sterile biopreservation media products in Bothell, Washington.
  • Our quality management system (“QMS”) in Indianapolis is certified to the ISO 9001:2015 standard.
  • Pursuant to our supply agreements, we are required to notify customers of any changes to our raw materials.
  • Thaw systems – Our ThawSTAR automated, water-free thawing products are produced by a CMO based in the United States.
  • Monitored shipping – Production of our evo cold chain management hardware products is performed by external CMOs and by personnel in our Bruce Township, Michigan facility.
  • Our QMS in Bruce Township is certified to the ISO 9001:2015 standard.
  • Product regulatory status Our products are not subject to any specific United States Food and Drug Administration (“FDA”) or other international marketing regulations for drugs, devices, or biologics.
  • To assist customers with their regulatory applications, we maintain Type II Master Files at the FDA for CryoStor, HypoThermosol FRS, BloodStor 27, Stemulate, nLiven PR, T-Liven PR, CellSeal Closed System Cryogenic Vials, CryoCase cryo-compatible transparent rigid containers, and our Cell Thawing Media products, which provide the FDA with information regarding our manufacturing facility and process, our quality system, stability and safety, and any additional testing that has been performed.
  • Despite these precautions, it may be possible for unauthorized third parties to copy certain aspects of our products and/or to obtain and use information that we regard as proprietary (see “Item 1A.
  • Risk Factors” of this Annual Report for additional details).
  • Issued Patents Patents Applied For Registered Trademarks Cell processing 57 32 41 Evo and thaw 40 79 11 Total 97 111 52 Competition Our bioproduction products and services compete on the basis of value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies.

and 59 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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