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What changed in BIOLIFE SOLUTIONS INC's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of BIOLIFE SOLUTIONS INC's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+335 added−333 removedSource: 10-K (2025-03-03) vs 10-K (2024-02-29)

Top changes in BIOLIFE SOLUTIONS INC's 2024 10-K

335 paragraphs added · 333 removed · 176 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

32 edited+21 added−27 removed36 unchanged
Biggest changeOur products Our bioproduction tools and services are comprised of three revenue lines that contain seven main offerings: • Cell processing ◦ Biopreservation media ◦ Human platelet lysate media (“hPL”), cryogenic vials, and automated cell-processing fill machines • Freezers and thaw systems ◦ Ultra-low temperature freezers ◦ Cryogenic freezers and accessories ◦ Automated thawing devices • Biostorage services ◦ Biological and pharmaceutical material storage and transport ◦ Cloud-connected “smart” shipping containers Subsequent to the second quarter of 2023, we began to seek divestment of our Global Cooling, Inc.
Biggest changeOur 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”).
Over the last several years, we have built a strong reputation as a trusted supplier of critical tools used in cell and gene therapy and biopharma manufacturing. We believe that our relationships and reputation could enable us to drive further incremental revenue growth through the sale of additional products to a captive customer base.
Over the last several years, we have built a strong reputation as a trusted supplier of critical tools used in cell and gene therapy and biopharma manufacturing. We believe that our relationships and reputation could enable us to drive further incremental revenue growth through the sale of additional products and services to a captive customer base.
Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, storage, and distribution. We currently operate as one bioproduction tools and services business which supports several steps in the biologic material manufacturing and delivery process.
Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, and distribution. We currently operate as one bioproduction products and services business which supports several steps in the biologic material manufacturing and delivery process.
The SEC also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov . 12 Table of Contents
The SEC also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov . 15 Table of Contents
We seek to manage single-source supplier risk by regularly assessing the quality and capacity of our suppliers, implementing supply and quality agreements where appropriate, and actively managing lead times and inventory levels of sourced components. Pursuant to our supply agreements, we are required to notify customers of any changes to our raw materials.
We seek to manage single-source supplier risk by regularly assessing the quality and capacity of our suppliers, implementing supply and quality agreements where appropriate, and actively managing lead times and inventory levels of 12 Table of Contents sourced components. Pursuant to our supply agreements, we are required to notify customers of any changes to our raw materials.
While competing cryopreservation freeze media is often comprised of a single permeating cryoprotectant such as dimethyl sulfoxide (“DMSO”), our CryoStor formulations incorporate multiple permeating and non-permeating cryoprotectant agents, which allows for multiple mechanisms of protection and reduces the dependence on a single cryoprotectant.
While competing cryopreservation freeze media is often comprised of a single permeating 9 Table of Contents cryoprotectant such as dimethyl sulfoxide (“DMSO”), our CryoStor formulations incorporate multiple permeating and non-permeating cryoprotectant agents, which allows for multiple mechanisms of protection and reduces the dependence on a single cryoprotectant.
Additional products using new technologies that may be competitive with our products may also be introduced. Many of the companies selling or developing competitive products have greater financial and human resources, R&D, manufacturing and marketing experience than we do.
Additional products using new 13 Table of Contents technologies that may be competitive with our products may also be introduced. Many of the companies selling or developing competitive products have greater financial and human resources, R&D, manufacturing, and marketing experience than we do.
Our products are designed to increase our customers’ product yield and functionality while reducing their risk, and we are committed to supporting our customers with strong service in addition to scientific and technical expertise in the applications of our products.
Our products are designed to increase our customers’ product 11 Table of Contents yield and functionality while reducing their risk, and we are committed to supporting our customers with strong service in addition to scientific and technical expertise in the applications of our products.
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, 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.
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.
Overview We are a life sciences company that develops, manufactures, and markets bioproduction tools and services which are designed to improve quality and de-risk biologic manufacturing, storage, distribution, and transportation in the cell and gene therapy (“CGT”) industry and broader biopharma markets. Our products are used in basic and applied research and commercial manufacturing of biologic-based therapies.
Overview We are a life sciences company that develops, manufactures, and markets bioproduction products and services which are designed to improve quality and de-risk biologic manufacturing, distribution, and transportation in the cell and gene therapy ("CGT") industry. Our products are used in basic and applied research and commercial manufacturing of biologic-based therapies.
Our products are designed to increase our customers’ product yield and we are committed to supporting our customers with strong customer service and applications expertise. We leverage our numerous relationships with leading cell and gene therapy companies that use our expanded offering of bioproduction tools and services to cross-sell other parts of the portfolio.
We are committed to supporting our customers with strong customer service and applications expertise. We leverage our numerous relationships with leading cell and gene therapy companies that use our offering of bioproduction products and services to cross-sell other parts of the portfolio.
Sexton's bioproduction tools portfolio includes human platelet lysates for cell expansion, which reduces risk and improves 6 Table of Contents 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, 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.
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.
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.
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.
Customers engaged in clinical and commercial applications may notify the FDA of their intention to use our products in their product development and manufacturing process by requesting a cross-reference to our master files.
Customers engaged in clinical and commercial applications may notify the FDA of their intention to use our products in their product development and manufacturing process by requesting a cross-reference to our master files. Intellectual property The following table lists our granted and pending patents.
Complementary products portfolio Expanding Participation in Customers ’ Workflow 8 Table of Contents Our strategy We are focused on the development, production, and commercialization of differentiated, best-in-class products and services that facilitate the manufacturing, delivery, and storage of cell and gene therapies and biologic materials.
Complementary products portfolio Expanding Participation in Customers ’ Workflow Our strategy We are focused on the development, production, and commercialization of differentiated, best-in-class products and services that facilitate the manufacturing and delivery of cell and gene therapies and biologic materials. Our products are designed to increase our customers’ product yield and efficacy.
We cannot be certain that the research, development and commercialization efforts of our competitors will not render any of our existing or potential products obsolete. 11 Table of Contents Human capital We view our employees and our culture as key to our success. As of December 31, 2023, we had 409 full time employees and 5 part-time employees.
We cannot be certain that the research, development, and commercialization efforts of our competitors will not render any of our existing or potential products obsolete. Human capital We view our team members as the key to our success. As of December 31, 2024, we had 159 full-time team members and no part-time team members.
Principal offices; available information Our principal executive offices are located at 3303 Monte Villa Parkway, Suite 310, Bothell, Washington 98021 and the telephone number is (425) 402-1400. We maintain a website at www.biolifesolutions.com .
Following the merger, we changed our name to BioLife Solutions, Inc. 14 Table of Contents Principal offices; available information Our principal executive offices are located at 3303 Monte Villa Parkway, Suite 310, Bothell, Washington 98021 and the telephone number is (425) 402-1400. We maintain a website at www.biolifesolutions.com .
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.
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.
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) 2023 2022 2021 United States (2) 80 % 79 % 85 % Europe, Middle East, Africa (EMEA) 16 % 16 % 11 % Other 4 % 5 % 4 % Total revenue 100 % 100 % 100 % (1) During the year ended December 31, 2023, the Company updated its methodology for determining the country of origin for its sales.
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.
We have experienced field-based sales employees who market our growing product portfolio on a direct basis. Our technical applications engineers and customer care support teams have extensive experience providing support both prior and subsequent to the sale of products.
We have experienced field-based sales employees who market our growing product portfolio on a direct basis. Our technical applications engineers and customer care support teams have extensive experience providing support both prior and subsequent to the sale of products. Our products are also marketed and distributed by STEMCELL Technologies, VWR, and other regional distributors under non-exclusive agreements.
See the diagram below for an illustration of this process and our product roles. We now offer products that integrate into the critical steps of preservation, thawing, and both fixed and transportable storage under controlled conditions.
The bioproduction process Our various products and services currently integrate into several steps in our customers’ bioproduction workflow process for cell and gene therapies. See the diagram below for an illustration of this process and our product roles. We offer products that integrate into the critical steps of preservation, thawing, and transportable storage under controlled conditions.
In addition, we maintain a business continuity management system that focuses on key areas such as contingency planning, safety stocks and off-site storage of raw materials and finished goods to ensure continuous supply of our products. Freezers and thaw systems – Ultra-low temperature (“ULT”) freezers are produced in our facilities in Athens, Ohio.
In addition, we maintain a business continuity management system that focuses on key areas such as contingency planning, safety stocks and off-site storage of raw materials and finished goods to ensure continuous supply of our products. Thaw systems – Our ThawSTAR automated, water-free thawing products are produced by a CMO based in the United States.
We have in-house expertise in cryobiology and the broader CGT workflow, and continue to evaluate opportunities to maximize the value of our product platforms for our extensive customer base through organic growth innovations, partnerships, and acquisitions.
We have a diversified portfolio of tools and services that focuses on biopreservation, cell processing, cold chain management tools, and thawing of biologic materials. We have in-house expertise in cryobiology and the broader CGT workflow, and continue to evaluate opportunities to maximize the value of our product platforms for our extensive customer base through organic growth innovations, partnerships, and acquisitions.
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.
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.
According to the Alliance for Regenerative Medicine (“ARM”), “2024 State of the Industry Briefing” there were approximately 1,900 ongoing clinical trials utilizing regenerative medicine at year-end 2023, with continued growth in CGT development companies throughout 2023. ARM also reported there was approximately $12 billion invested in the regenerative medicine market in 2023.
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.
In 2002, the Company, then known as Cryomedical Sciences, Inc. was engaged in manufacturing and marketing cryosurgical products. The entity was merged with our wholly owned subsidiary, BioLife Solutions, Inc., which was engaged as a developer and marketer of biopreservation media products for cells and tissues. Following the merger, we changed our name to BioLife Solutions, Inc.
The entity was merged with our wholly owned subsidiary, BioLife Solutions, Inc., which was engaged as a developer and marketer of biopreservation media products for cells and tissues.
Issued Patents Patents Applied For Registered Trademarks Cell processing 56 16 41 Freezers and thaw systems 85 71 25 Biostorage services 13 33 6 Total 154 120 72 Competition Our bioproduction products and services compete on the basis of value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies.
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.
Our US FDA Type II Master File applicable to our biopreservation products has been cross referenced over 690 times by our customers, and we believe our cell processing products are utilized in several hundred active clinical trials worldwide. 5 Table of Contents Stability (i.e. shelf-life) and functional recovery are crucial aspects of academic research and clinical practice in the biopreservation of biologic-based source material, intermediate derivatives, and isolated/derived/expanded cellular products and therapies.
Our US FDA Type II Master File applicable to our biopreservation products has been cross referenced over 750 times by our customers, and we believe our cell processing products are utilized in several hundred active clinical trials worldwide.
Biostorage services – Production of our evo cold chain management hardware products is performed by external CMOs and by personnel in our Bruce Township, Michigan facility. As of the year-ended December 31, 2023, we fully transitioned our manufacturing operations from Albuquerque, New Mexico to our facility in Bruce Township, Michigan.
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.
We believe we are well positioned to address many of the unique manufacturing challenges in the process of delivering cell and gene therapies. The bioproduction process Our various products and services currently integrate into several steps in our customers’ bioproduction workflow process for cell and gene therapies.
The manufacturing, distribution and the delivery process of these therapies is significantly different from many other types of treatments. We believe we are well positioned to address many of the unique manufacturing challenges in the process of delivering cell and gene therapies.
Our state-of-the-art monitoring systems allow customers real time tracking of the storage temperatures of their materials throughout the logistics process. We operate five storage facilities in the USA and one facility in the Netherlands. Cloud connected “ smart ” shipping containers We are a leading developer and supplier of next generation cold chain management tools for cell and gene therapies.
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.
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. (2) The line item presented above previously bifurcated sales between the United States and Canada.
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.
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We have a diversified portfolio of tools and services that focuses on biopreservation, cell processing, frozen biologic storage products and services, cold-chain logistics, and thawing of biologic materials.
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Upon the execution of the Global Cooling Purchase Agreement, the Global Cooling business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
Removed
(“GCI”) and Custom Biogenic Systems (“CBS”) freezer product lines (the “Freezer Business”) from our current product portfolio. For additional information regarding our ongoing initiative to divest the Freezer Business, see “Item 1A. Risk Factors” of this Annual Report for additional details.
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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.
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We estimate that annual revenue from each customer commercial application in which our products are used could range from $0.5 million to $2.0 million if such application is approved and our customer commences large scale commercial manufacturing of the biologic-based therapy. Human platelet lysate media, cryogenic vials and automated cell-processing fill machines In September 2021, we acquired Sexton Biotechnologies, Inc.
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Upon the execution of the SciSafe Purchase Agreement, the SciSafe business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
Removed
For our Sexton vials and media, we estimate that annual revenue from each customer commercial application in which these products are used could also range from $0.5 million to $2.0 million, if such application is approved and our customer commences large scale commercial manufacturing of the biologic-based therapy.
Added
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”).
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Biostorage services Biological and pharmaceutical storage and transport We are a premier provider of biological and pharmaceutical storage and cold chain logistics. These services ensure that materials are kept at controlled, target temperatures from the moment they leave the customer’s premises to their ultimate return.
Added
Upon the execution of the CBS Purchase Agreement, the CBS business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented. 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.
Removed
Freezers and thaw systems Ultra-low temperature freezers Our portfolio of ultra-low temperature freezers range in size from portable units to stationary upright freezers, accommodating a wide variety of use cases. Users can configure these freezers to achieve temperatures between -20°C and -86°C.
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The Consolidated 8 Table of Contents Statements Of Comprehensive Loss, Consolidated Statements of Shareholders' Equity, and Consolidated Statements of Cash Flows are presented on a consolidated basis for both continuing operations and discontinued operations. All amounts, percentages, and disclosures for all periods presented in this Annual Report reflect only the continuing operations of the Company unless otherwise noted.
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The portfolio was designed to be environmentally friendly and energy efficient, using as little as 2.8 kWh/day at temperatures of -80°C. The freezers do not use compressor-based or cascade refrigeration systems. Instead, they use patented free-piston Stirling engine technology that uses fewer moving parts.
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See Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the divestitures described above.
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Cryogenic freezers and accessories Our line of cryogenic freezers offer leading design and manufacture of state-of-the-art liquid nitrogen laboratory freezers, cryogenic equipment and accessories. Our Isothermal LN2 freezers are constructed with a patented system which stores liquid nitrogen in a jacketed space in the walls of the freezer.
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Stability (i.e. shelf-life) and functional recovery are crucial aspects of academic research and clinical practice in the biopreservation of biologic-based source material, intermediate derivatives, and isolated/derived/expanded cellular products and therapies.
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This dry storage method eliminates liquid nitrogen contact with stored specimens, reducing the risk of cross-contamination and providing increased user safety in a laboratory setting by limiting liquid nitrogen contact injuries. To accommodate customer requirements, we offer customizable features, including wide bodied and extended height models.
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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. 10 Table of Contents The technologies developed within the CGT market change the ways physicians treat patients.
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Our high-capacity controlled rate freezers (“HCFR”) are designed for large volume storage with customizable freezing programs and the ability to monitor conditions in real time. 7 Table of Contents To accompany the offerings of cryogenic freezer equipment, we supply equipment for storing critically important biological materials.
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In 2024, 2023, and 2022, sales to third-party distributors accounted for 35%, 44%, and 42% of our revenue, respectively.
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This storage equipment includes upright freezer racks, chest freezer racks, liquid nitrogen freezer racks, canisters/cassettes and frames, as well as laboratory boxes and dividers. Due to our onsite design and manufacturing capabilities, racks and canisters can be customized to address customers’ varying requirements.
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Our Company culture encourages strong team collaboration and an emphasis on participation in challenging tasks that expand our team's skill sets. We believe in an open-door policy at all levels of the organization and establish Company-wide quarterly townhall meetings to foster a collaborative, connected environment in which anyone can contribute to our success.
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In addition, ARM predicts up to 17 US and EU cell and gene therapy regulatory approvals may be granted during 2024. The technologies developed within the CGT market change the ways physicians treat patients. The manufacturing, distribution and the delivery process of these therapies is significantly different from many other types of treatments.
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Our human capital strategy revolves around retaining top talent and maintaining high engagement across our Company. We consider relations with our team members to be good and welcome feedback from all levels of the Company on how to make improvements in our business processes and Company culture.
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Our products are also marketed and distributed by STEMCELL Technologies, MilliporeSigma, VWR, Avantor, Thermo Fisher, and several other regional distributors under non-exclusive agreements. In 2023, 2022, and 2021, sales to third-party distributors accounted for 49%, 50%, and 46% of our revenue, respectively.
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Team Member Engagement We value a high level of engagement from our team members. We endeavor to foster a culture of mutual respect and ensure that team members feel valued.
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During the years ended December 31, 2023, 2022, and 2021, we derived approximately 16% , 18%, and 17% of our revenue from the same customer, respectively.
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We compete for local talent with companies that are both in our market and within proximity to our primary office locations, as well as for our remote workforce within our industry and across other industries.
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Due to the updated methodology for determining the country of origin for sales, it was noted that Canada no longer was a material location to 9 Table of Contents separately disclose.
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We offer a hybrid work model that enables our team members to work remotely and on-location as their responsibilities allow, and we support team events to build internal collaboration and engagement. We support our team members’ participation in Company social events to build community engagement and foster a sense of responsibility to the communities in which we work.
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Canada sales have been included within the "Other" line item in the table above and United States sales has been retained as its own line item to more accurately reflect origin of sales for material regions. Manufacturing Cell processing – We maintain and operate two independent cGMP clean room production suites for manufacturing sterile biopreservation media products in Bothell, Washington.
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Compensation and Benefits We view our compensation and benefits practices as critical to our recruitment, retention, and engagement efforts. We prioritize competitive health benefits for our team members and employ a pay-for-performance compensation model, paying at or above market rates for our positions.
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As of the second quarter in 2023, we fully transitioned two freezer product lines under our ULT manufacturing operations from a contract manufacturing organization ("CMO") in Ohio to in-house production within the Athens, Ohio facility. The majority of our isothermal LN2 freezers and related accessories are manufactured in our facility in Bruce Township, Michigan.
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We also offer incentive programs for certain employees focused on incentivizing and retaining talent that include stock grants and bonus incentives and provide a generous paid time off program including additional holidays granted throughout the year.
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We are reliant on certain critical suppliers for some components. To date, we have not experienced significant difficulties in obtaining raw materials for the manufacture of our LN2 freezers and related accessories. Our ThawSTAR automated, water-free thawing products are produced by a CMO based in the United States.
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Training and Development We have a strong belief in promotion from within our Company and provide training and development opportunities to support our talented professionals in their career growth. We offer internal training, peer-to-peer learning opportunities, and mentorship of our team members.
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We leased a new, smaller facility in Albuquerque, New Mexico to retain engineering and administrative operations personnel. Our QMS is certified to the ISO 9001:2015 standard.
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Health and Safety We provide a safe and healthy work environment that encourages team members to speak up and identify potential safety hazards. We conduct employee ergonomics assessments specifically in our manufacturing processes to limit and eliminate potential injuries from repetitive movements.
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SciSafe operates five cGMP compliant storage facilities in the United States and one facility in the Netherlands, which is registered with the European Regulatory body in Netherlands (IGJ) for Good Distribution of Active Pharmaceutical Ingredients.
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We provide training for specific safety requirements and modify processes as needed to assure that our team members’ health and safety is a part of every aspect of our business. We provide appropriate personal protective equipment and training for the use of that equipment for safe use.
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One facility in the United States is certified to the ISO 20387:2018 standard, and all facilities, both in the United States and the Netherlands, are certified to the ISO 9001:2015 standard.
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Corporate history We were incorporated in Delaware in 1987 under the name Trans Time Medical Products, Inc. In 2002, the Company, then known as Cryomedical Sciences, Inc. was engaged in manufacturing and marketing cryosurgical products.
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We rely on outside suppliers for the build-out of our cold-storage chambers and stand-alone freezers. 10 Table of Contents Supply chain constraints - Our domestic and international supply chain operations were affected during the years ended December 31, 2021 and 2022 by the global COVID-19 pandemic and the resulting volatility and uncertainty it caused in the U.S. and international markets.
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The onset of the COVID-19 pandemic caused supply chains globally to become constrained, and these constraints historically impacted our business through both increased difficulty in obtaining semiconductor chips and increased pricing on available parts across our product lines during the years ended December 31, 2021 and 2022.
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However, during the year ended December 31, 2023, both availability and pricing of semiconductor chips have improved and no longer pose constraints on our supply chain. We currently have sufficient supply for electrical component parts within our operations and do not foresee constraints to return over our supply chain.
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A group of isothermal, standard, and carousel LN2 freezers in our freezers and thaw systems product line is currently regulated as Class 2 medical devices in the EU. Intellectual property The following table lists our granted and pending patents.
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Our employees are not covered by any collective bargaining agreement. We consider relations with our employees to be good. Since March 2020, we have operated with a flexible work environment in which positions not essential to being on-site may embrace hybrid ways of working.
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Overall, we aim to preserve the flexibility offered by hybrid work arrangements while offering our employees a healthy, supportive, and inclusive environment that supports their development, provides connection, and propels team and individual performance. Corporate history We were incorporated in Delaware in 1987 under the name Trans Time Medical Products, Inc.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

79 edited+91 added−49 removed64 unchanged
Biggest changeProvisions in our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws may have the effect of delaying or preventing a change of control or changes in our management, including provisions that: • authorize our board of directors to issue, without further action by the stockholders, undesignated preferred stock; 22 Table of Contents • allow stockholders to require us to call a special meeting of stockholders upon written request of the holders of 35% of the outstanding shares entitled to vote thereat; • establish an advance notice procedure for stockholder nominations; • provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and • specify that no stockholder is permitted to cumulate votes at any election of directors.
Biggest changeCertain provisions in our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws may have the effect of delaying or preventing a change of control or changes in our management, including, among other things, provisions that: • authorize our Board to issue, without further action by the stockholders, shares of preferred stock and to determine the price and other terms, including preferences and voting rights; • restrict the ability of our stockholders to call a special meeting of stockholders except upon written request of the holders of 35% of the outstanding shares entitled to vote thereat; • establish advance notice procedural mechanics and disclosure requirements applicable to stockholder nominations of directors and submissions of proposals regarding other business at stockholder meetings; and • provide that any vacancies on our Board resulting from death, resignation, disqualification, removal or other cause or in increase in the authorized number of directors may be filled only by a majority of directors then in office, even though less than a quorum, or by the sole remaining director.
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. To address our material weaknesses, we have developed and begun to implement the remediation plans described in Item 9A — Controls and Procedures and elsewhere in this Form 10-K.
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. To address our material weaknesses, we have developed and begun to implement the remediation plans described in Item 9A — Controls and Procedures in this Form 10-K.
Threats to our systems and our associated third parties’ systems can derive and have derived from human error, fraud or malice on the part of employees or third parties, or may result from accidental technological failure, including as a result of natural disasters, power failures or other events beyond our control.
Additionally, threats to our systems and our associated third parties’ systems can derive and have derived from human error, fraud or malice on the part of employees or third parties, or may result from accidental technological failure, including as a result of natural disasters, power failures or other events beyond our control.
These rules generally operate by focusing on ownership changes involving stockholders owning directly or indirectly 5% or more of the stock of a company and any change in ownership arising from a new issuance of stock by the company.
These rules generally operate by focusing on ownership changes involving stockholders owning directly or indirectly 5% or more of the stock of a company and any change in ownership arising from a new issuance of stock by us.
Such access has led and could lead in the future to the compromise of sensitive, business, personal or confidential information or instructions to transfer funds by us or customers to unauthorized recipients. In the third quarter during the year ended December 31, 2022, we experienced an immaterial security breach that successfully redirected payments from BioLife customers to unauthorized bank accounts.
Such access has led and could lead in the future to the compromise of sensitive, business, personal or confidential information or instructions to transfer funds by us or customers to unauthorized recipients. In the third quarter during the year ended December 31, 2022, we experienced an immaterial security breach that successfully redirected payments from our customers to unauthorized bank accounts.
As described in Item 9A — Controls and Procedures and elsewhere in this Form 10-K, Management identified material weaknesses in our internal control over financial reporting for the fiscal years ended December 31, 2023 and 2022. Effective internal control over financial reporting is necessary to provide reliable financial reports and to assist in the effective prevention of fraud.
As described in Item 9A — Controls and Procedures and elsewhere in this Form 10-K, Management identified material weaknesses in our internal control over financial reporting for the fiscal years ended December 31, 2024 and 2023. Effective internal control over financial reporting is necessary to provide reliable financial reports and to assist in the effective prevention of fraud.
Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of the company’s stock immediately before the ownership change.
Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of our stock immediately before the ownership change.
Our revenue, operating margins and other operating results have varied significantly in the past and may continue to fluctuate from period to period in the future due to a variety of factors, many of which are beyond our control.
We expect our operating results to fluctuate significantly from period to period. Our revenue, operating margins and other operating results have varied significantly in the past and may continue to fluctuate from period to period in the future due to a variety of factors, many of which are beyond our control.
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.
Risks related to accounting matters 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.
The future market price and trading volume of our common stock could be significantly impacted by numerous factors, including, but not limited to: • Future sales of our common stock or other capital raising events by us; • Sales of our common stock by existing shareholders; • Changes in our capital structure, including stock splits or reverse stock splits; • Changes in our product offerings and business structure through acquisitions or divestitures; • Announcements of technological innovations for new commercial products by our present or potential competitors; • Developments concerning proprietary rights; • Adverse results in our field or with clinical tests of our products in customer applications; • Adverse litigation; • Unfavorable legislation or regulatory decisions; • Public concerns regarding our products; • Variations in quarterly operating results; • General trends in the health care industry; • Global viruses, epidemics, and pandemics, including COVID-19; and • Other factors outside of our control, including significant market fluctuations.
The future market price and trading volume of our common stock could be significantly impacted by numerous factors, including, but not limited to: • Future sales of our common stock or other capital raising events by us; • Sales of our common stock by existing shareholders; • Changes in our capital structure, including stock splits or reverse stock splits; • Changes in our product offerings and business structure through acquisitions or divestitures, and public perception of our announced acquisitions and divestitures; • Announcements of technological innovations for new commercial products by our present or potential competitors; • Developments concerning proprietary rights; • Adverse results in our field or with clinical tests of our products in customer applications; • Adverse litigation; • Unfavorable legislation or regulatory decisions; • Public concerns regarding our products; • Variations in quarterly operating results; • General trends in the health care and biotechnology industries; • Global viruses, epidemics, and pandemics; and • Other factors outside of our control, including significant market fluctuations.
In addition, the patent positions of life science industry companies are 18 Table of Contents highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. As a result, the validity and enforceability of our patents cannot be predicted with certainty.
In addition, the patent positions of life science industry companies are highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. As a result, the validity and enforceability of our patents cannot be predicted with certainty.
Risks related to accounting matters 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.
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.
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.
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.
If efficient manufacture and supply of our products is interrupted, we may experience delayed shipments or supply constraints.
If efficient manufacturing and supply of our products is interrupted, we may experience delayed shipments or supply constraints.
While we currently maintain product liability insurance, directors’ and officers’ liability insurance, general liability insurance, and other types of insurance, first- and third-party insurance is increasingly more costly and narrower in scope, and we may be required to assume more risk in the future.
While we currently maintain product liability insurance, directors’ and officers’ liability insurance, general liability insurance, and other types of insurance, first- and third-party insurance is increasingly more difficult to obtain and maintain and has become more costly and narrower in scope, and we may be required to assume more risk in the future.
Any acquisition involves numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, financial condition, or results of operations: • difficulties in integrating new operations, technologies, products, and personnel; • problems maintaining uniform procedures, controls, and policies with respect to our financial accounting systems; • lack of synergies or the inability to realize expected synergies and cost-savings; • difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience; • underperformance of any acquired technology, product, or business relative to our expectations and the price we paid; • negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges; • the potential loss of key employees, customers, and strategic partners of acquired companies; • claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction; • the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash; • diversion of management’s attention and company resources from existing operations of the business; • inconsistencies in standards, controls, procedures, and policies; • cash expenses and non-cash accounting charges incurred in connection with acquisitions, including unanticipated costs associated with the amortization of intangible assets; • the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies; 14 Table of Contents • assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities, including product liability, that are difficult to identify or accurately quantify; and • risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
As a part of our growth strategy, we have made, and may continue to make, selected acquisitions of other companies and technologies and continue to evaluate expansion through acquisitions of other companies or technologies, which may carry numerous risks and operational, financial, and managerial challenges, including, but not limited to, the following, any of which could adversely affect our business, financial condition, or results of operations: • difficulties in integrating new operations, technologies, products, and personnel; • problems maintaining uniform procedures, controls, and policies with respect to our financial accounting systems; • lack of synergies or the inability to realize expected synergies and cost-savings; • difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience; • underperformance of any acquired technology, product, or business relative to our expectations and the price we paid; • negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges; • the potential loss of key strategic partners of acquired companies; • claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction; • the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash; • diversion of management’s attention and company resources from existing operations of the business; • inconsistencies in standards, controls, procedures, and policies; • cash expenses and non-cash accounting charges incurred in connection with acquisitions, including unanticipated costs associated with the amortization of intangible assets; • the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies; • assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities, including product liability, that are difficult to identify or accurately quantify; and • risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
While we maintain product liability insurance coverage, which we deem to be adequate based on historical experience, there can be no assurance that coverage will be available for such risks in the future or that, if available, it would prove sufficient to cover potential claims or that the present amount of insurance can be maintained in force at an acceptable cost to us.
While we maintain product liability insurance coverage, which we deem to be adequate based on historical experience, we cannot assure you that coverage will be available for such risks in the future or that, if available, it would prove sufficient to cover potential claims or that the present amount of insurance can be maintained in force at an acceptable cost to us.
The manufacture of our products may be impacted by: • availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier; • the ongoing capacity of our facilities and those of our outside manufacturers; • our and our outside manufacturers’ ability to comply with existing and new regulatory requirements, including cGMP; • inclement weather and natural disasters; • changes in forecasts of future demand for product components; • potential facility contamination by microorganisms or viruses; • updating of manufacturing specifications; • product quality success rates and yields; • labor strike; and • global viruses and pandemics, including COVID-19.
Manufacturing our products may be impacted by: • availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier; • the ongoing capacity of our facilities and those of our outside manufacturers; • our and our outside manufacturers’ ability to comply with existing and new regulatory requirements, including cGMP; • inclement weather and natural disasters; • changes in forecasts of future demand for product components; 18 Table of Contents • potential facility contamination by microorganisms or viruses; • updating of manufacturing specifications; • product quality success rates and yields; • labor strikes; and • global viruses, pandemics and epidemics.
Our business exposes us to potential product liability risks that are inherent in designing, manufacturing, and marketing our products. In particular, we are a supplier of bioproduction tools to the cell and gene therapy industry. Our products are used in basic and applied research, and commercial manufacturing of biologic-based therapies.
Our business exposes us to potential product liability risks that are inherent in designing, manufacturing, and marketing our products. In particular, we are a supplier of bioproduction products to the cell and gene therapy industry. Our products are used in basic and applied research, and commercial manufacturing of biologic-based therapies and must meet stringent requirements.
Accordingly, a material weakness increases the risk that the financial information we report contains material errors. In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2023, we identified several material weaknesses.
Accordingly, a material weakness increases the risk that the financial information we report contains material errors. In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2024, we identified one material weakness.
We are subject to the risk of disruption by earthquakes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war, terrorist attacks and other hostile acts, public health issues, epidemics or pandemics and other events beyond our control and the control of the third parties on which we depend.
We are subject to the risk of disruption by earthquakes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war, terrorist attacks and other hostile acts and other events beyond our control and the control of the third parties on which we depend.
A catastrophic event that results in the destruction or disruption of our data centers or our critical business or information technology systems would severely affect our ability to conduct normal business operations and, as a result, our operating results would be adversely affected. ITEM 1B. UNRESOLVED STAFF COMMENTS None.
A catastrophic event that results in the destruction or disruption of our data centers or our critical business or information technology systems would severely affect our ability to conduct normal business operations and, as a result, our operating results would be adversely affected.
While we are not currently subject to FDA or other regulatory approvals on substantially all of our products, 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. None of our products are subject to FDA regulation.
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.
Material weaknesses were identified in relation to (i) ineffective control environment attributed to the acquisition of six private companies in 2019 – 2021 without the proper internal control infrastructure in place, insufficient resources with the appropriate level of internal controls training, knowledge, and expertise to meet our financial reporting requirements and provide adequate oversight over the performance of internal controls, and turnover in the first half of 2023 in key positions, resulting in a delay in establishing control activities to effectively mitigate the risks; (ii) internal control procedures over certain financial statement areas; and (iii) change management controls over certain key financial systems. 23 Table of Contents In the course of making our assessment of the effectiveness of internal control over financial reporting as of December 31, 2022, we identified several material weaknesses.
Material weaknesses were identified in relation to (i) ineffective control environment attributed to the acquisition of six private companies in 2019 – 2021 without the proper internal control infrastructure in place, insufficient resources with the appropriate level of internal controls training, knowledge, and expertise to meet our financial reporting requirements and provide adequate oversight over the performance of internal controls, and turnover in the first half of 2023 in key positions, resulting in a delay in establishing control activities to effectively mitigate the risks; (ii) internal control procedures over certain financial statement areas; and (iii) change management controls over certain key financial systems.
The efforts of governmental and third-party payors to contain or reduce the costs of healthcare and, more generally, to reform the U.S. healthcare system may adversely affect the business and financial condition of pharmaceutical and biotechnology companies, including ours.
In response to perceived increases in healthcare costs in recent years, the efforts of governmental and third-party payors to contain or reduce the costs of healthcare and, more generally, to reform the U.S. healthcare system may adversely affect the business and financial condition of pharmaceutical and biotechnology companies, including ours.
In particular, the financial or operational impacts as a result of COVID-19 or other future public health crises have included, and may in the future include: • The temporary closure of our manufacturing facilities and/or those of our outside manufacturers; • Unavailability of supplies and other components for our products, including difficulties in obtaining sheet metal and electrical components incorporating semiconductor chips for the manufacture of our UL freezer products, which have largely abated during the year ended December 31, 2023 ; • Costs associated with protecting the health of our employees and adhering to any guidance or orders of various governmental authorities, such masking, testing, and social distancing requirements; • Risks associated with remote work, including increased cybersecurity risk; • Widespread staffing shortages; 24 Table of Contents • Outbreaks of disease in our facilities or those of our third-party service providers, which could require us or them to temporarily shut down business operations or cause a disruption to, or shortage in, our or their workforce; • Significant volatility or reductions in demand for our products; • Delays in shipments of our products, which could harm our customer relations and adversely impact our competitive position and sales; • Restrictions on the ability of our personnel to access customers; • Challenges to our capacity to manufacture, sell and support the use of our products; and • Volatility in credit or financial markets.
In particular, the financial or operational impacts as a result of public health crises have included, and may in the future include: • The temporary closure of our manufacturing facilities and/or those of our outside manufacturers; • Unavailability of supplies and other components for our products; • Costs associated with protecting the health of our employees and adhering to any guidance or orders of various governmental authorities, such masking, testing, and social distancing requirements; • Risks associated with remote work, including increased cybersecurity risk; • Widespread staffing shortages; • Outbreaks of disease in our facilities or those of our third-party service providers, which could require us or them to temporarily shut down business operations or cause a disruption to, or shortage in, our or their workforce; • Significant volatility or reductions in demand for our products; • Delays in shipments of our products, which could harm our customer relations and adversely impact our competitive position and sales; • Restrictions on the ability of our personnel to access customers; • Challenges to our capacity to manufacture, sell and support the use of our products; and • Volatility in credit or financial markets.
Accordingly, we could experience product liability losses in the future and 17 Table of Contents incur significant costs to defend these claims.
Accordingly, we could experience product liability losses in the future and incur significant costs to defend these claims.
Enforcement of these agreements may be costly and time consuming. 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.
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.
Anti-takeover 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 and limit the market price 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 .
As of December 31, 2023, based on our review of public filings and the Company’s records, one of our existing stockholders, Casdin Capital, LLC (“Casdin”), owned 8,707,165 shares of our common stock, representing 19.3% of the issued and outstanding shares of common stock.
As of December 31, 2024, based on our review of public filings and our records, one of our existing stockholders, Casdin Capital, LLC owned 8,707,165 shares of our common stock, representing 18.6% of the issued and outstanding shares of common stock.
Our proprietary rights may not adequately protect our technologies and products. Our commercial success will depend on our ability to obtain patents and/or regulatory exclusivity and maintain adequate protection for our technologies and products in the United States and other countries.
Our policy is to seek to protect our proprietary position and our commercial success will depend on our ability to obtain patents and/or regulatory exclusivity and maintain adequate protection for our technologies and products in the United States and other countries.
Further, the inability of some of our customers to consummate anticipated purchases of our products due to changes in end-user demand, and other unpredictable factors that may affect customer ordering patterns could lead to significant reductions in net product revenue which could harm our business. We expect our operating results to fluctuate significantly from period to period.
Further, the inability of some of our customers to consummate anticipated purchases of our products due to changes in end- 16 Table of Contents user demand, and other unpredictable factors that may affect customer ordering patterns could lead to significant reductions in net product revenue which could harm our business.
Efforts by governments and 15 Table of Contents other third-party payors to contain or reduce the costs of healthcare through various means may limit our commercial opportunities and adversely affect our operating results and result in a decrease in the price of our common stock or limit our ability to raise capital.
Efforts by governments and other third-party payors to contain or reduce the costs of healthcare through various means may limit our commercial opportunities and adversely affect our operating results and result in a decrease in the price of our common stock or limit our ability to raise capital. We anticipate additional uncertainty as debates about healthcare and public health continue.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
Our Board could rely on Delaware law to prevent or delay an acquisition of us. These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board, which is responsible for appointing the members of our management.
We are a regular target of malicious third-party attempts, some of which have been successful, to identify and exploit system vulnerabilities and/or penetrate or bypass our security measures in order to gain unauthorized access to our networks and systems or those of our associated third parties.
We are continually subject to cyberattacks and the risk of data security incidents, some of which have been successful. Such incidents include malicious third party attempts to identify and exploit system vulnerabilities and/or penetrate or bypass our security measures in order to gain unauthorized access to our networks and systems or those of our associated third parties.
In the event of a recall, we may experience lost sales and be exposed to individual or class-action litigation claims and reputational risk. Product liability, warranty and recall costs may have a material adverse effect on our business, financial condition and results of operations. Insurance coverage is increasingly difficult to obtain or maintain.
In the event of a recall, we may experience lost sales and be exposed to individual or class-action litigation claims and reputational risk. Product liability, warranty and recall costs may have a material adverse effect on our business, financial condition and results of operations. Difficulties in manufacturing could have an adverse effect upon our expenses and our product revenues.
Our stock price and trading volume and the market prices and trading volume of many publicly traded companies, including companies in the life sciences industry, have been, and can be expected to be, highly volatile.
We may continue to incur substantial increases or decreases in our stock price and volume in the foreseeable future. Our stock price and trading volume and the market prices and trading volume of many publicly traded companies, including companies in the life sciences industry, have been, and can be expected to be, highly volatile.
In addition, without the consent of this stockholder where a stockholder vote may be necessary, we could be prevented from entering into transactions that could be beneficial to us. We do not anticipate declaring any cash dividends on our common stock.
In addition, without the consent of this stockholder where a stockholder vote may be necessary, we could be prevented from entering into transactions that could be beneficial to us. We have not paid dividends on our common stock in the past and do not expect to pay dividends in the foreseeable future.
Any future reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.
Any reduction or impairment of value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods. We depend on outside suppliers for all our manufacturing supplies, parts and components.
The laws of some non-U.S. countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions.
These products may compete with our products and may not be covered by any patent claims or other intellectual property rights. The laws of some non-U.S. countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions.
The sale of a large number of shares of our common stock or other securities also might make it more difficult for us to sell equity or equity-related securities in the future at a time and at the prices that we deem appropriate 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.
The sale of a large number of shares of our common stock or other securities also might make it more difficult for us to sell equity or equity-related securities in the future at a time and at the prices that we deem appropriate.
In addition, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including sales and marketing, research and development, manufacturing, finance, legal, and information technologies. Our acquisitions we may not be successful or may not be, or remain, profitable.
Additionally, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including sales and marketing, research and development, manufacturing, finance, legal, and information technologies.
Further, in the future, if we cannot conclude that we have effective internal control over financial reporting or disclosure controls and procedures, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price.
We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of our financial statements will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or disclosure controls and procedures. 28 Table of Contents Further, in the future, if we cannot conclude that we have effective internal control over financial reporting or disclosure controls and procedures, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price.
Our defensive measures in the past have not, and in the future, may not, prevent downtime, unauthorized access, or use of sensitive data. Further, while we select our associated third parties carefully, and we seek to ensure that our customers adequately protect their systems and data, we do not control their actions and are not able to oversee their processes.
Further, while we select our associated third parties carefully, and we seek to ensure that our customers adequately protect their systems and data, we do not control their actions and are not able to oversee their processes.
Such developments could have a material adverse effect on our business, financial condition and results of operations. Also, even if we can compete successfully, we may not continue do so in a profitable manner. We depend on outside suppliers for all our manufacturing supplies, parts and components.
Such developments could have a material adverse effect on our business, financial condition and results of operations. Also, even if we can compete successfully, we may not continue do so in a profitable manner. Despite our increasingly diversified customer base, we depend on a limited number of customers and products in a limited number of market sectors.
Unavailability of necessary components could require us to re-engineer our products to accommodate available substitutions, which could increase costs to us and/or have a material adverse effect on manufacturing schedules, products performance and market acceptance.
Unavailability of necessary components could require us to re-engineer our products to accommodate available substitutions, which could increase costs to us and/or have a material adverse effect on manufacturing schedules, products performance and market acceptance. We might not be able to find a sufficient alternative supplier in a reasonable amount of time, or on commercially reasonable terms, if at all.
In some of the larger economic territories, such as the United States and Europe, patent term extension/restoration may be available. We cannot, however, be certain that an extension will be granted or, if granted, what the applicable time or the scope of patent protection afforded during any extended period will be.
We cannot, however, be certain that an extension will be granted or, if granted, what the applicable time or the scope of patent protection afforded during any extended period will be.
In addition, an uncorrected defect or supplier’s variation in a component or raw material, either unknown to us or incompatible with our manufacturing process, could harm our ability to manufacture products. We might not be able to find a sufficient alternative supplier in a reasonable amount of time, or on commercially reasonable terms, if at all.
If we fail to obtain an alternative supplier for the components of our products, our operations could be disrupted. In addition, an uncorrected defect or supplier’s variation in a component or raw material, either unknown to us or incompatible with our manufacturing process, could harm our ability to manufacture products.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business. If we fail to protect our intellectual property rights, our competitors may take advantage of our ideas and compete directly against us.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss 20 Table of Contents of our U.S. patent position with respect to such inventions.
The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.
We rely on outside suppliers, including several single-source suppliers, for all our manufacturing supplies, parts and components. There can be no assurance that, in the future, our current or alternative sources for manufacturing supplies will be able to meet all our demands on a timely basis.
We cannot assure you that, in the future, our current or alternative sources for manufacturing supplies will be able to meet all our demands on a timely basis.
If we are subject to third-party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to share that risk in excess of our insurance limits.
If we are subject to third-party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to share that risk in excess of our insurance limits. A partially or completely uninsured claim, if successful and of significant magnitude, could have a material adverse effect on our business, financial condition and results of operations.
Risks related to our common stock Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses. The trading price and volume of our common stock, traded on the NASDAQ Capital Market ("NASDAQ"), has been, and may in the future be, volatile.
Risks related to our common stock 25 Table of Contents Our stock price and volume may be volatile, and purchasers of our securities could incur substantial losses.
We cannot predict whether third parties will assert these claims against us, or whether those claims will harm our business. If we are forced to defend against these claims, whether they are with or without any merit and whether they are resolved in favor of or against us, we may face costly litigation and diversion of management’s attention and resources.
If we are forced to defend against these claims, whether they are with or without any merit and whether they are resolved in favor of or against us, we may face costly litigation and diversion of management’s attention and resources. As a result of these disputes, we may have to develop costly non-infringing technology, or enter into licensing agreements.
In conducting our business, we process, transmit and store sensitive, proprietary and confidential information about our employees, customers, vendors, and other parties, including business and personal information. This information may include account access credentials, credit and debit card numbers, bank account numbers, social security numbers, driver’s license numbers, names and addresses and other types of sensitive business or personal information.
This information may, include, but is not limited to, account access credentials, credit and debit card numbers, bank account numbers, social security numbers, driver’s license numbers, names and addresses and other types of sensitive business or personal information.
In addition, confidentiality 19 Table of Contents agreements with our employees, consultants, customers, and key vendors may not prevent the unauthorized disclosure or use of our technology. It is possible that these agreements will be breached or that they will not be enforceable in every instance, and that we will not have adequate remedies for any such breach.
It is possible that these agreements will be breached or that they will not be enforceable in every instance, and that we will not have adequate remedies for any such breach.
The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
Even if we are granted a patent, in certain circumstances we may be unable protect our rights to, or use of, our technology. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.
Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all. Our recent acquisitions may result in unexpected consequences to our business and results of operations.
We are unable to guarantee the success of any acquisitions that we complete and such acquisitions may not be, or remain, 21 Table of Contents profitable. 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.
If our competitors independently develop equivalent knowledge, methods, and know-how, we would not be able to assert our trade secrets against them and our business could be harmed. We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting, and defending patents on all our products in every jurisdiction would be prohibitively expensive.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting, and defending patents on all our products in every jurisdiction would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products.
However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Any litigation in this regard could be costly, and it is possible that we will not have sufficient resources to fully pursue litigation or to protect our intellectual property rights.
However, these legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage.
We are subject to risks associated with public heath crises, including those related to the COVID-19 global pandemic. The COVID-19 pandemic has created significant volatility, uncertainty, and economic disruption, which has had, and may continue to have, an adverse effect our business operations, results of operations, cash flows and financial condition.
For example, the COVID-19 pandemic created significant volatility, uncertainty, and economic disruption, which had an adverse effect on our business operations, results of operations, cash flows and financial condition.
This could result in the rejection or invalidation of our existing and future patents. Any adverse outcome in litigation relating to the validity of our patents, or any failure to pursue litigation or otherwise to protect our patent position, could materially harm our business and financial condition.
Any adverse outcome in litigation relating to the validity of our patents, or any failure to pursue litigation or otherwise to protect our patent position, could materially harm our business and financial condition. In addition, confidentiality agreements with our employees, consultants, customers, and key vendors may not prevent the unauthorized disclosure or use of our technology.
Our principal customers may vary from period to period and such customers may not continue to purchase products from us at current levels or at all.
In the years ended December 31, 2024, 2023, and 2022, we derived approximately 73%, 73%, and 77% of our revenue from CryoStor products, respectively. Our principal customers may vary from period to period and such customers may not continue to purchase products from us at current levels or at all.
For example, in the year ended December 31, 2023, the highest intra-day sale price of our common stock on NASDAQ was $26.89 per share and the lowest intra-day sale price of our common stock on NASDAQ 21 Table of Contents was $8.92 per share.
For example, in the year ended December 31, 2024, the highest intra-day sale price of our common stock on NASDAQ was $28.88 per share and the lowest intra-day sale price of our common stock on NASDAQ was $14.50 per share. Our highest trading day volume was 1,692,900 shares traded and the lowest trading day volume was 106,600 shares traded.
We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability.
We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability. Risks related to disruptive events Public health crises have adversely affected, and could in the future adversely affect, our business, financial condition. results of operations and cash flows.
We currently outsource the manufacturing of certain thaw products, certain cold chain products, two ULT freezer models, and components of our LN2 freezers. The manufacturing of our products is difficult and complex. To support our current and prospective clinical customers, we comply with, and intend to continue to comply with, cGMP in the manufacture of our products.
To support our current and prospective clinical customers, we and our outsources manufacturers comply with, and intend to continue to comply with, cGMP in the manufacture of our products.
Any such requirements could delay or prevent the sale of our products or may subject us to additional expenses. 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.
If we fail to attract and retain such personnel, our sales efforts will be hindered and we will not be able to achieve our growth objectives. 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.
As a result of these disputes, we may have to develop costly non-infringing technology, or enter into licensing agreements. These agreements, if necessary, may be unavailable on terms acceptable to us, if at all, which could seriously harm our business or financial condition.
These agreements, if necessary, may be unavailable on terms acceptable to us, if at all, which could seriously harm our business or financial condition. We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
We have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future. Our current policy is to retain all funds and earnings for use in the operation and expansion of our business.
Our current policy is to retain all funds and earnings for use in the operation and expansion of our business.
Many of our competitors are significantly larger than us and have greater financial, technical, research, marketing, sales, distribution and other resources than us and may have longer operating histories. These companies may develop technologies that are superior alternatives to our products or may be more effective at commercializing and marketing their technologies in products.
While there are technological and marketing barriers to entry, we cannot guarantee that these barriers will be sufficient to defend our market share against current and future competitors. Many of our competitors are significantly larger than us and have greater financial, technical, research, marketing, sales, distribution and other resources than us and may have longer operating histories.
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. As a part of our growth strategy, we have made, and may continue to make, selected acquisitions of complementary products and/or businesses.
In addition, stockholder activism may constrain our capital deployment opportunities and may limit the types of investments that are available to us. Risks related to our acquisition strategy 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.
If we fail to attract and retain skilled scientific and sales personnel, our sales efforts will be hindered. Our future success depends to a significant degree upon the continued services of key scientific and technical personnel.
Our future success depends to a significant degree upon the continued services of key scientific and technical personnel. We are continually at risk of losing such personnel or being unable to hire additional engineering, scientific, sales and management personnel.
Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The NASDAQ Stock Market LLC or other regulatory authorities. Risks related to disruptive events Public health crises, such as the COVID-19 pandemic, have adversely affected, and could in the future adversely affect, our business, financial condition. results of operations and cash flows.
Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The NASDAQ Stock Market LLC or other regulatory authorities.
Risks related to our intellectual property and cyber security Expiration of our patents may subject us to increased competition and reduce our opportunity to generate product revenue. The patents for our products have varying expiration dates and, when these patents expire, we may be subject to increased competition and we may not be able to recover our development costs.
The patents for our products have varying expiration dates and, when these patents expire, we may be subject to increased competition and we may not be able to recover our development costs. In some of the larger economic territories, such as 22 Table of Contents the United States and Europe, patent term extension/restoration may be available.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. We cannot predict whether third parties will assert these claims against us, or whether those claims will harm our business.
Risks related to our financial condition Despite our increasingly diversified customer base, we depend on a limited number of customers and products in a limited number of market sectors. 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.
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. During the years ended December 31, 2024, 2023, and 2022, we derived approximately 28%, 25%, and 32% of our revenue from two customers, respectively.
If our quarterly operating results fail to meet expectations of investors or research analysts, the price of our common stock may decline. We have announced that we intend to divest our Freezer Business.
If our quarterly operating results fail to meet expectations of investors or research analysts, the price of our common stock may decline. If intangible assets and goodwill become impaired, we may have to take significant charges against earnings. As of December 31, 2024 the net carrying value of our goodwill and other intangible assets totaled $221.9 million.
Our inability to protect our systems and data from continually evolving cybersecurity risks or other technological risks, including as a result of breaches of our associated third parties' information technology systems, could affect our ability to conduct our business.
A loss of key personnel or their work product could diminish or prevent our ability to commercialize our products, which could have an adverse effect on our business, results of operations and financial condition. 24 Table of Contents 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.
Accordingly, any transactions that we complete could have a material adverse effect on our business, results of operations, financial condition, and prospects. Risks related to our business and operations Healthcare reform measures could adversely affect our business and financial results.
Healthcare reform measures could adversely affect our business and financial results.
Removed
During the years ended December 31, 2023, 2022, and 2021, we derived approximately 16%, 18%, and 17% of our revenue from the same customer, respectively. No other customer accounted for more than 10% of revenue in the years ended December 31, 2023, 2022 and 2021.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe consult with outside counsel as needed, with final decisions made by senior management. 25 Table of Contents The Audit Committee oversees cybersecurity risks and incidents, ensuring compliance with disclosure requirements and cooperation with law enforcement. Senior management regularly updates the committee on cyber risks and any material incidents.
Biggest changeWe consult with outside counsel as needed, with final decisions made by senior management. The Audit Committee oversees cybersecurity risks and incidents, ensuring compliance with disclosure requirements and cooperation with law enforcement. Senior management regularly updates the committee on cyber risks and any material incidents.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changePROPERTIES Our material office and manufacturing leases are detailed below: Location Square Feet Principal Use Lease Expiration Bothell, WA 45,522 Corporate headquarters, manufacturing, research and development, marketing, and administrative offices July 2031 Woodinville, WA 13,578 Warehouse January 2030 Albuquerque, NM 2,940 Research and development and administrative offices April 2027 Bruce Township, MI 106,998 Manufacturing, research and development, and administrative offices Month to Month Athens, OH 50,000 Manufacturing, research and development, and administrative offices March 2028 Nelsonville, OH 24,114 Warehouse June 2024 Columbus, OH 1,807 Administrative offices January 2025 Indianapolis, IN 11,415 Manufacturing, research and development, and administrative offices September 2024 United States 12,500 Biological and pharmaceutical specimen storage January 2027 United States 26,600 Biological and pharmaceutical specimen storage March 2024 United States 16,153 Biological and pharmaceutical specimen storage June 2024 United States 16,800 Biological and pharmaceutical specimen storage February 2026 United States 26,800 Biological and pharmaceutical specimen storage November 2031 Netherlands 47,533 Biological and pharmaceutical specimen storage March 2026 We consider the facilities to be in a condition suitable for their current uses.
Biggest changePROPERTIES Our material office and manufacturing leases are detailed below: Location Square Feet Principal Use Lease Expiration Bothell, WA 75,168 Corporate headquarters, manufacturing, research and development, marketing, and administrative offices July 2031 Woodinville, WA 13,578 Warehouse January 2030 Albuquerque, NM 2,940 Research and development and administrative offices April 2027 Indianapolis, IN 11,415 Manufacturing, research and development, and administrative offices December 2026 We consider the facilities to be in a condition suitable for their current uses.
Because of anticipated growth in the business and due to the increasing requirements of customers or regulatory agencies, we may need to acquire additional space or upgrade and enhance existing space. We believe that adequate facilities will be available upon the conclusion of our leases.
Due to the increasing requirements of customers or regulatory agencies, we may need to acquire additional space or upgrade and enhance existing space. We believe that adequate facilities will be available upon the conclusion of our leases.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Added
MINE SAFETY DISCLOSURES Not applicable. PART II 31 Table of Contents

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeMARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market information for common stock Our common stock is traded on the NASDAQ Stock Market under the trading symbol “BLFS.” 26 Table of Contents Stockholders and dividends As of February 22, 2024, there were approximately 256 holders of record of our common stock.
Biggest changeITEM 5. MARKET FOR REGISTRANT ’ S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market information for common stock Our common stock is traded on the NASDAQ Stock Market under the trading symbol “BLFS.” Stockholders and dividends As of February 24, 2025, there were approximately 221 holders of record of our common stock.
Any future determination as to the payment of dividends will be at the sole discretion of our Board of Directors and will depend on our financial condition, results of operations, capital requirements and other factors our Board of Directors deems relevant.
Any future determination as to the payment of dividends will be at the sole discretion of our Board and will depend on our financial condition, results of operations, capital requirements and other factors our Board deems relevant.
The following graph shows the cumulative total stockholder return on our common stock with the cumulative total return of the S&P Small Cap 600 Index and our peer group, assuming an initial investment of $100 on December 31, 2018 and the reinvestment of all dividends. Issuer repurchases of equity securities Not applicable. ITEM 6. RESERVED Reserved.
The following graph shows the cumulative total stockholder return on our common stock with the cumulative total return of the S&P Small Cap 600 Index and our peer group, assuming an initial investment of $100 on December 31, 2019 and the reinvestment of all dividends. Issuer repurchases of equity securities Not applicable.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

57 edited+44 added−77 removed33 unchanged
Biggest changeThe benefit recognized in the year ended December 31, 2023 relates primarily to changes in our estimated probability of achieving earnout targets set forth within the purchase agreements. 34 Table of Contents Other income and expenses Total other income and expenses for the years ended December 31, 2023, 2022, and 2021 were comprised of the following: Year Ended December 31, 2023 vs. 2022 2022 vs. 2021 (In thousands, except percentages) 2023 2022 2021 $ Change % Change $ Change % Change Change in fair value of warrant liability $ — $ — $ (121) $ — — % $ 121 (100) % Change in fair value of investments — 697 — (697) (100 %) 697 — % Interest expense, net (1,812) (687) (485) (1,125) 164 % (202) 42 % Other income 1,264 704 289 560 80 % 415 144 % Gain on settlement of Global Cooling escrow 5,115 — — 5,115 — % — — % Gain on acquisition of Sexton Biotechnologies, Inc. — — 6,451 — — % (6,451) (100 %) Total other income, net $ 4,567 $ 714 $ 6,134 $ 3,853 540 % $ (5,420) (88 %) Change in fair value of warrant liability.
Biggest changeOther income and expenses Total other income and expenses for the years ended December 31, 2024, 2023, and 2022 were comprised of the following: Year Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In thousands, except percentages) 2024 2023 2022 $ Change % Change $ Change % Change Interest expense, net (719) (1,449) (284) 730 50 % (1,165) (410) % Other income 497 1,303 662 (806) (62 %) 641 97 % Change in fair value of investments (4,074) — 697 (4,074) NM (697) (100) % Gain on settlement of Global Cooling escrow — 5,115 — (5,115) (100 %) 5,115 100 % Total other (expense) income, net $ (4,296) $ 4,969 $ 1,075 $ (9,265) (186) % $ 3,894 362 % Interest expense, net .
Capital requirements Our future capital requirements will depend on many factors, including the following: • the expansion of our cell and gene therapy tools and services business • the ability to sustain product revenue and profits of our cell and gene therapy products and services; • The degree to which we implement additional automated production equipment throughout our facilities; • our ability to acquire additional cell and gene therapy products and services; • the scope of and progress made in our research and development activities; and • the success of any proposed financing efforts.
Capital requirements Our future capital requirements will depend on many factors, including the following: • the expansion of our cell and gene therapy business • the ability to sustain product revenue and profits of our cell and gene therapy products and services; • the degree to which we implement additional automated production equipment throughout our facilities; • our ability to acquire additional cell and gene therapy products and services; • the scope of and progress made in our research and development activities; and • the success of any proposed financing efforts.
Reflects the non-cash gain associated with our post-closing adjustments for indemnifications and negotiated terms in connection with our acquisition of Global Cooling, and subsequent release and cancellation of these shares of our common stock from the third-party escrow account established in connection with that transaction.
Reflects the non-cash gain associated with our post-closing adjustments for indemnifications and negotiated terms in connection with our acquisition of Global Cooling in 2023, and subsequent release and cancellation of these shares of our common stock from the third-party escrow account established in connection with that transaction.
Our products are used in basic and applied research and commercial manufacturing of biologic-based therapies. Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, storage, and distribution.
Our products are used in basic and applied research and commercial manufacturing of biologic-based therapies. Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, and distribution.
The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value. The Company operates as one reporting unit as of the goodwill impairment measurement date in the fourth quarter of 2023.
The quantitative assessment considers whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value. The Company operates as one reporting unit as of the goodwill impairment measurement date in the fourth quarter of 2024.
The following summarizes certain of our contractual obligations as of December 31, 2023 and the effect such obligations are expected to have on our cash flows in the next fiscal year: Long-term debt, including interest These amounts represent expected cash payments, including principal and interest.
The following summarizes certain of our contractual obligations as of December 31, 2024 and the effect such obligations are expected to have on our cash flows in the next fiscal year: Long-term debt, including interest These amounts represent expected cash payments, including principal and interest.
Definite-lived intangible assets and their related estimated useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. 29 Table of Contents Indefinite-lived intangibles are carried at the initially recorded fair value less any recognized impairment. Indefinite-lived intangibles are tested annually for impairment.
Definite-lived intangible assets and their related estimated useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. Indefinite-lived intangibles are carried at the initially recorded fair value less any recognized impairment. Indefinite-lived intangibles are tested annually for impairment.
As a result, a full valuation allowance on its deferred tax assets was recorded as of December 31, 2023. The Company will continue to assess the realizability of its assets going forward and will adjust the valuation allowance as needed.
As a result, a full valuation allowance on its deferred tax assets was recorded as of December 31, 2024. The Company will continue to assess the realizability of its assets going forward and will adjust the valuation allowance as needed.
For additional details on the factors considered in the write-off, see Note 3: Fair value measurement within the consolidated financial statements in Part II, Item 8 of this Annual Report.
For additional details on the factors considered in the write-off, see Note 4: Fair value measurement within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
Lease obligations We have various operating and financing lease agreements for office space, warehouses, manufacturing, research equipment, machinery, and production locations as well as vehicles and other equipment. Lease obligations are described in Note 6 of the Consolidated Financial statements in Part II, Item 8 of this Annual Report.
Lease obligations We have various operating and financing lease agreements for office space, warehouses, manufacturing, research equipment, machinery, and production locations as well as vehicles and other equipment. Lease obligations are described in Note 7: Leases of the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
Based upon a review of the four sources of income identified within ASC 740, Accounting for Income Taxes , the Company determined that the Company’s recorded deferred tax liabilities as of December 31, 2023 would be a sufficient source of taxable income to realize all of its deferred tax assets except for a portion of its net operating loss carryforwards.
Based upon a review of the four 35 Table of Contents sources of income identified within ASC 740, Accounting for Income Taxes , the Company determined that the Company’s recorded deferred tax liabilities as of December 31, 2024 would be a sufficient source of taxable income to realize all of its deferred tax assets except for a portion of its net operating loss carryforwards.
It is probable that we will be subject to sales tax liabilities plus interest and penalties relating to historical activity in certain states. We have estimated a contingent liability for sales tax which is recorded in the Consolidated Balance Sheet.
It is probable that we will be subject to sales tax liabilities plus 42 Table of Contents interest and penalties relating to historical activity in certain states. We have estimated a contingent liability for sales tax which is recorded in the Consolidated Balance Sheet.
The Company primarily recognizes product revenues, service revenues, and rental revenues. Product revenues are generated from the sale of biopreservation media, ThawSTAR, and freezer products. We recognize product revenue, 28 Table of Contents including shipping and handling charges billed to customers, when we transfer control of our products to our customers.
The Company primarily recognizes product revenues, service revenues, and rental revenues. Product revenues are generated from the sale of biopreservation media and ThawSTAR products. We recognize product revenue, including shipping and handling charges billed to customers, when we transfer control of our products to our customers.
The increase in cash provided by financing activities compared to the prior year is primarily due to a private placement of $10.4 million and proceeds from financed insurance premiums of $2.6 million, offset by payments on financed insurance premiums of $2.4 million. In the year ended December 31, 2022, cash provided by financing activities was $16.3 million.
In the year ended December 31, 2023, cash provided by financing activities was $10.6 million. The increase in cash provided by financing activities compared to the prior year was primarily due to a private placement of $10.4 million and proceeds from financed insurance premiums of $2.6 million, offset by payments on financed insurance premiums of $2.4 million.
As of December 31, 2023, our total obligations were $13.9 million, of which $13.7 million was short-term. Sales Tax We are in the process of evaluating a state sales tax liability analysis for states in which we have economic nexus, and collecting exemption documentation from our customers.
As of December 31, 2024, our total obligations were $3.7 million, of which $3.1 million was short-term. Sales Tax We are in the process of evaluating a state sales tax liability analysis for states in which we have economic nexus, and collecting exemption documentation from our customers.
If impairment indicators are present, the Company determines whether the underlying intangible asset is recoverable through estimated future undiscounted cash flows.
If impairment indicators are present, the Company determines whether the underlying intangible asset is recoverable through estimated future 34 Table of Contents undiscounted cash flows.
We currently operate as one bioproduction tools and services business which supports several steps in the biologic material manufacturing and delivery process. We have a diversified portfolio of tools and services that focus on biopreservation, cell processing, frozen biologic storage products and services, cold-chain transportation, and thawing of biologic materials.
We currently operate as one bioproduction products and services business which supports several steps in the biologic material manufacturing and delivery process. We have a diversified portfolio of tools and services that focuses on biopreservation, cell processing, and thawing of biologic materials.
Our effective tax rate for 2022 was lower than the U.S. statutory rate of 21% primarily due to our valuation allowance.
Our effective tax rate for 2024 was lower than the U.S. statutory rate of 21% primarily due to the change in our valuation allowance.
Despite these uncertainties, we believe that our balances of cash, cash equivalents, available-for-sale securities, and restricted cash in addition to our cash flows from operations are adequate to meet our liquidity requirements in the next 12 months.
Despite these uncertainties, we believe that our balances of cash, cash equivalents, and available-for-sale securities in addition to our cash flows from operations are adequate to meet our liquidity requirements in the foreseeable future.
General and administrative expenses During the years ended December 31, 2023, 2022, and 2021, general and administrative (“G&A”) expense consisted primarily of personnel-related expenses, stock-based compensation, professional fees, such as accounting and consulting fees, and corporate insurance. In the year ended December 31, 2023, G&A expenses increased by $8.1 million, or 17%, compared with the year ended December 31, 2022.
General and administrative During the years ended December 31, 2024, 2023, and 2022, general and administrative (“G&A”) expense consisted primarily of personnel-related expenses, stock-based compensation, professional fees, such as accounting and consulting fees, and corporate insurance. In the year ended December 31, 2024, G&A expenses decreased by $2.7 million, or 6%, compared with the year ended December 31, 2023.
Intangible asset amortization expense Amortization expense consists of charges related to the amortization of intangible assets associated with the acquisitions of Global Cooling, Custom Biogenic Systems (“CBS”), SciSafe, Sexton, SAVSU Technologies, Inc. (“SAVSU”), and Astero in which we acquired definite-lived intangible assets.
Intangible asset amortization expense Amortization expense consists of charges related to the amortization of intangible assets associated with the acquisitions of Sexton, SAVSU Technologies, Inc. (“SAVSU”), and Astero in which we acquired definite-lived intangible assets.
Revenue recognition To determine revenue recognition for contractual arrangements that we determine are within the scope of Financial Accounting Standards Board (“FASB”) Topic 606, Revenue from Contracts with Customers , we perform the following five steps: (i) identify each contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligation.
Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions. 33 Table of Contents Revenue recognition To determine revenue recognition for contractual arrangements that we determine are within the scope of Financial Accounting Standards Board (“FASB”) Topic 606, Revenue from Contracts with Customers , we perform the following five steps: (i) identify each contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligation.
Debt obligations are described in Note 13 of the Consolidated Financial statements in Part II, Item 8 of this Annual Report. As of December 31, 2023, our total obligations were $25.2 million, of which $6.8 million was short-term.
Debt obligations are described in Note 13: Long-term debt of the Consolidated Financial Statements in Part II, Item 8 of this Annual Report. As of December 31, 2024, our total obligations were $15.9 million, of which $10.9 million was short-term.
MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Company Overview 27 Table of Contents We are a life sciences company that develops, manufactures and supplies bioproduction tools and services which are designed to improve quality and de-risk biologic manufacturing, storage, distribution, and transportation in the cell and gene therapy industry and broader biopharma market.
ITEM 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Company Overview We are a life sciences company that develops, manufactures, and markets bioproduction products and services which are designed to improve quality and de-risk biologic manufacturing, distribution, and transportation in the cell and gene therapy industry.
Absent acquisitions of additional products, product candidates, or intellectual property, we believe our current cash, cash equivalents, and available-for-sale securities balances, in addition to our cash flows from operations, are adequate to meet our cash needs for at least the next 12 months as of the date of this filing.
Absent acquisitions of additional products, product candidates, or intellectual property, we believe our current cash, cash equivalents, and available-for-sale securities balances, in addition to our cash flows from operations, are adequate to meet our cash needs for the foreseeable future.
Liquidity and capital resources We believe our cash, cash equivalents, restricted cash, cash generated from operations, available-for-sale securities, and credit lines will satisfy, for at least the next twelve months from the date of this filing, our liquidity requirements, both globally and domestically, including the following: working capital needs, capital expenditures, ongoing initiative for divestiture of the Freezer Business, contractual obligations, commitments, principal and interest payments on debt, and other liquidity requirements associated with our operations.
Liquidity and capital resources We believe our cash, cash equivalents, cash generated from operations, available-for-sale securities, and credit lines will satisfy, for at least the foreseeable future, our liquidity requirements, both globally and domestically, including the following: working capital needs, capital expenditures, contractual obligations, commitments, principal and interest payments on debt, and other liquidity requirements associated with our operations.
This limits the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Subsequent ownership changes may further affect the limitation in future years.
The NOL carryforwards are subject to an annual limitation in the event of certain cumulative changes in the ownership interest. This limits the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Subsequent ownership changes may further affect the limitation in future years.
Shipping and handling costs are classified as part of cost of product revenue in the Consolidated Statement of Operations. Service revenues are generated from the storage of biological and pharmaceutical materials. We recognize service revenues over time as services are performed or ratably over the contract term.
Shipping and handling costs are classified as part of cost of product revenue in the Consolidated Statement of Operations. Service revenues are generated from various customer service agreements to provide warranty and other engineering services. We recognize service revenues over time as services are performed or ratably over the contract term.
As of December 31, 2023, our total obligations were $17.5 million, of which $3.2 million was short-term.
As of December 31, 2024, our total obligations were $14.2 million, of which $1.5 million was short-term.
Intangible assets and goodwill Intangible assets Intangible assets with a definite life are amortized over their estimated useful lives using the straight-line method and the amortization expense is recorded within intangible asset amortization in the Consolidated Statements of Operations.
We account for these rental transactions as operating leases and record rental revenue on a straight-line basis over the rental term. Intangible assets and goodwill Intangible assets Intangible assets with a definite life are amortized over their estimated useful lives using the straight-line method and the amortization expense is recorded within intangible asset amortization in the Consolidated Statements of Operations.
Contractual obligations Our cash flows from operations are dependent on a number of factors, including fluctuations in our operating results, accounts receivable collections, inventory management, and the timing of tax and other payments.
Contractual obligations Our cash flows from operations are dependent on a number of factors, including fluctuations in our operating results, accounts receivable collections, inventory management, and the timing of tax and other payments. As a result, the impact of contractual obligations on our liquidity and capital resources in future periods should be analyzed in conjunction with such factors.
Critical accounting policies and estimates We have identified the policies and estimates below as being critical to our business operations and the understanding of our results of operations. These policies require management’s most difficult, subjective, or complex judgements, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
These policies require management’s most difficult, subjective, or complex judgements, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Cost of product, rental, and service revenue as a percentage of revenue was 69% and 70% for the years ended December 31, 2023 and 2022, respectively.
Cost of product, rental, and service revenue as a percentage of revenue, inclusive of intangible asset amortization, was 38% and 43% for the years ended December 31, 2024 and 2023, respectively.
For additional information, see Note 12 within the consolidated financial statements in Part II, Item 8 of this Annual Report. Gain on acquisition of Sexton Biotechnologies, Inc.
For additional information on the divestiture of CBS, see Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
Cash flows Year Ended December 31, 2023 vs. 2022 (In thousands, except percentages) 2023 2022 $ Change % Change Operating activities $ (12,498) $ (8,488) $ (4,010) (47 %) Investing activities 17,837 (58,117) 75,954 131 % Financing activities 10,591 16,316 (5,725) (35) % Net increase (decrease) in cash and cash equivalents $ 15,930 $ (50,289) $ 66,219 132 % Operating activities In the year ended December 31, 2023, our operating activities used cash of $12.5 million reflecting net loss of $66.4 million and non-cash charges totaling $53.9 million primarily related to stock-based compensation, impairment of assets, depreciation, amortization, changes in fair value of contingent consideration, gain on settlement of Global Cooling escrow, and non-cash lease charges.
Year Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In thousands, except percentages) 2024 2023 2022 $ Change % Change $ Change % Change Operating activities $ 8,431 $ (12,498) $ (8,488) $ 20,929 167 % $ (4,010) (47 %) Investing activities 58,300 17,837 (58,117) 40,463 227 % 75,954 131 % Financing activities (6,783) 10,591 16,316 (17,374) (164) % (5,725) (35) % Net increase in cash and cash equivalents $ 59,948 $ 15,930 $ (50,289) $ 44,018 276 % $ 66,219 132 % Operating activities In the year ended December 31, 2024, our operating activities provided cash of $8.4 million, reflecting non-cash charges totaling $28.6 million primarily related to stock-based compensation, gain recognized on disposals of subsidiaries, depreciation, amortization, and changes in fair value of investments.
In the year ended December 31, 2022, our operating activities used cash of $8.5 million reflecting net loss of $139.8 million and non-cash charges totaling $146.2 million primarily related to impairment of intangible assets, depreciation, amortization, changes in fair value of contingent consideration, deferred income tax benefit, stock-based compensation, and non-cash lease charges.
In the year ended December 31, 2023, our operating activities used cash of $12.5 million reflecting a net loss of $68.0 million and non-cash charges totaling $55.5 million primarily related to stock-based compensation, impairment of assets, depreciation, amortization, changes in fair value of contingent consideration, gain on settlement of Global Cooling escrow, and non-cash lease charges.
Capital expenditures and purchases of assets held for rent to maintain and expand the Company's operations used $11.2 million. Our investing activities used $58.1 million of cash in the year ended December 31, 2022.
In the year ended December 31, 2023, investing activities provided $17.8 million of cash. We had $29.1 million in net proceeds of available-for-sale securities to fund capital projects and operations. Capital expenditures and purchases of assets held for rent to maintain and expand the Company's operations used $11.2 million.
Significant changes in operating assets and liabilities include a decrease of accounts receivable of $15.3 million, an increase in inventory of $8.6 million, and a decrease in accounts payable of $8.4 million.
Significant changes in operating assets and liabilities include an increase of accounts receivable of $2.9 million, an increase of prepaid expenses of $2.4 million, and a decrease in accrued expenses of $6.5 million.
On October 19, 2023, we entered into a Securities Purchase Agreement with Casdin Partners Master Fund, L.P. ("Casdin") whereby the Company sold, and Casdin purchased, 927,165 shares of common stock of the Company at a share price of $11.19 per share for an aggregate purchase price of $10.4 million.
("Casdin") whereby we sold, and Casdin purchased, 927,165 shares of our common stock at a share price of $11.19 per share for an aggregate purchase price of $10.4 million.
Our current portfolio of bioproduction tools and services are comprised of three revenue lines that contain seven main offerings: (i) cell processing (including biopreservation media for the preservation of cells and tissues, human platelet lysate media for the supplementation of cell expansion, cryogenic vials and automated fill machines that provide high-quality, efficient, and precise mixes of solutions), (ii) freezers and thaw systems (including a full line of mechanical ultra-low temperature (“ULT”), isothermal, and liquid nitrogen freezers and accessories, automated thaw devices which provide controlled, consistent thawing of frozen biologics in vials and cryobags), and (iii) Biostorage services (including biological and pharmaceutical storage services and transport, and “smart”, cloud connected devices for transporting biologic payloads).
Our current portfolio of bioproduction products and services are comprised of two revenue lines that contain four main offerings: (i) cell processing (including biopreservation media for the preservation of cells and tissues, human platelet lysate media for the supplementation of cell expansion, cryogenic vials and automated fill machines that provide high-quality, efficient, and precise mixes of solutions) and (ii) Evo and ThawSTAR devices (including “smart”, cloud connected devices for transporting biologic payloads and automated thawing systems).
The increase is primarily due to $2.0 million of increased stock compensation and $0.7 million of increased advertising. 33 Table of Contents Research and development expenses During the years ended December 31, 2023, 2022, and 2021, research and development (“R&D”) expense consisted primarily of personnel-related costs, consulting, research supplies, and milestone expenses related to third party research agreements.
Research and development During the years ended December 31, 2024, 2023, and 2022, research and development (“R&D”) expense consisted primarily of personnel-related costs, consulting, research supplies, and milestone expenses related to third party research agreements. R&D expense decreased $4.2 million in the year ended December 31, 2024, or 34%, compared with the year ended December 31, 2023.
We continue to seek to acquire such potential assets that may offer us the best opportunity to create value for our shareholders. In order to acquire such assets, we may need to seek additional financing to fund these investments.
In order to acquire such assets, we may need to seek additional financing to fund these investments.
The Company is generally subject to examination by U.S. federal and local income tax authorities for all tax years in which loss carryforward is available. 31 Table of Contents As of December 31, 2023, the Company had U.S. federal net operating loss (“NOL”) carryforwards of approximately $151.9 million, which is available to reduce future taxable income.
As of December 31, 2024, the Company has an unrecognized tax benefit of $1.2 million related to tax attributes being carried forward. The Company is generally subject to examination by U.S. federal and local income tax authorities for all tax years in which loss carryforward is available.
R&D expense increased $4.0 million in the year ended December 31, 2023, or 27%, compared with the year ended December 31, 2022. The increase is primarily due to $2.5 million of increased stock-based compensation expenses and $1.0 million of scrapped research materials related to an adjustment in the design of a future freezer product release that rendered certain components obsolete.
S&M expense increased $1.0 million, or 9%, in the year ended December 31, 2023, compared with the year ended December 31, 2022. The increase is primarily due to an increase in personnel expenses, including stock-based compensation expenses, of $1.2 million.
None of the Company’s contracts contained a significant financing component or variable consideration as of and during the years ended December 31, 2023, 2022, and 2021.
None of the Company’s contracts contained a significant financing component or variable consideration as of and during the years ended December 31, 2024, 2023, and 2022. The Company also generates revenue from the leasing of our evo cold chain systems to customers pursuant to rental arrangements entered into with the customer.
Sales and marketing expenses During the years ended December 31, 2023, 2022, and 2021, sales and marketing expense (“S&M”) consisted primarily of personnel-related costs, stock based compensation, consulting, advertising, and travel expenses. S&M expense increased $3.0 million in the year ended December 31, 2023, or 14%, compared with the year ended December 31, 2022.
Finally, we also experienced increases in professional fees related to potential merger activities of $3.6 million and increases in accounting fees of $0.6 million. Sales and marketing During the years ended December 31, 2024, 2023, and 2022, sales and marketing expense (“S&M”) consisted primarily of personnel-related costs, consulting, trade shows, advertising, and travel expenses.
Increases in interest expenses during the year ended December 31, 2023 can also be attributed primarily to interest incurred on the Term Loan (as defined under Note 13: Long-term debt within the consolidated financial statements in Part II, Item 8 of this Annual Report) drawn in the quarter ended September 30, 2022. Gain on settlement of Global Cooling escrow.
Interest expense incurred in the year ended December 31, 2024 related primarily to the Term Loan (as defined in Note 13: Long-term debt within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report), financed insurance premiums, and indirect tax liabilities.
Our future capital requirements may include, but are not limited to, purchases of property and equipment, the acquisition of additional cell and gene therapy products and technologies, and continued investment in our intellectual property portfolio. 38 Table of Contents We actively evaluate various strategic transactions on an ongoing basis, including acquiring complementary products, technologies or businesses that would complement our existing portfolio.
We expect to incur continued spending related to our other existing product lines and expansion of our commercial capabilities for the foreseeable future. Our future capital requirements may include, but are not limited to, purchases of property and equipment, the acquisition of additional cell and gene therapy products and technologies, and continued investment in our intellectual property portfolio.
Management classifies investments at the time of purchase and reevaluates such classification at each balance sheet date. The decrease in available-for-sale securities of $27.8 million resulted from the maturity of $52.7 million of available-for-sale securities during the year, offset by purchases of similar instruments of $27.1 million.
This increase was partially offset by cash used in financing activities of $6.8 million. Our available-for-sale securities consist of U.S. government securities, corporate debt securities, and other debt securities. Management classifies investments at the time of purchase and reevaluates such classification at each balance sheet date.
Revenue from these arrangements is not within the scope of FASB ASC Topic 606 as it is within the scope of FASB ASC Topic 842, Leases . All customers leasing shippers currently do so under month-to-month rental arrangements. We account for these rental transactions as operating leases and record rental revenue on a straight-line basis over the rental term.
Revenue from these arrangements is not within the scope of FASB ASC Topic 606 as it is within the scope of FASB ASC Topic 842, Leases .
On December 31, 2023, we had $52.3 million in cash, cash equivalents, and available-for-sale securities, compared to $64.1 million as of December 31, 2022, as follows: Year Ended December 31, 2023 vs. 2022 (In thousands, except percentages) 2023 2022 $ Change % Change Cash and cash equivalents $ 35,407 $ 19,442 $ 15,965 82 % Restricted cash 31 31 — — % Available-for-sale securities 16,836 44,592 (27,756) (62) % Maturities in less than one year 16,288 43,260 (26,972) (62) % Maturities in greater than one year 548 1,332 $ (784) (59) % Total cash, cash equivalents, and available-for-sale securities $ 52,274 $ 64,065 $ (11,791) (18) % The increase in cash and cash equivalents of $16.0 million as of December 31, 2023 is primarily due to the sale and maturity of our available for sale securities of $27.8 million, change in accounts receivable of $15.4 million, and proceeds from financing activities of $10.6 million.
Change in cash, cash equivalents, and available-for-sale securities On December 31, 2024, we had $109.2 million in cash, cash equivalents, and available-for-sale securities, compared to $44.7 million as of December 31, 2023, as follows: 40 Table of Contents Year Ended December 31, 2024 vs. 2023 (In thousands, except percentages) 2024 2023 $ Change % Change Cash and cash equivalents $ 95,386 $ 27,896 $ 67,490 242 % Available-for-sale securities 13,826 16,836 (3,010) (18) % Maturities in less than one year 9,198 16,288 (7,090) (44) % Maturities in greater than one year 4,628 548 $ 4,080 745 % Total cash, cash equivalents, and available-for-sale securities $ 109,212 $ 44,732 $ 64,480 144 % The increase in cash and cash equivalents of $67.5 million as of December 31, 2024 as compared with the year ended December 31, 2023 is primarily due to the proceeds received from the disposals of SciSafe and CBS, which were $71.3 million and $3.4 million, respectively.
Costs and operating expenses Total costs and operating expenses for years ended December 31, 2023, 2022, and 2021 were comprised of the following: Year Ended December 31, 2023 vs. 2022 2022 vs. 2021 (In thousands, except percentages) 2023 2022 2021 $ Change % Change $ Change % Change Cost of product, rental, and service revenue $ 96,519 $ 107,937 $ 82,108 $ (11,418) (11 %) $ 25,829 31 % General and administrative 55,725 47,670 33,668 8,055 17 % 14,002 42 % Sales and marketing 24,583 21,570 14,006 3,013 14 % 7,564 54 % Research and development 18,796 14,798 11,821 3,998 27 % 2,977 25 % Asset impairment charges 15,485 110,364 — (94,879) (86 %) 110,364 - % Intangible asset amortization 5,181 9,697 8,202 (4,516) (47 %) 1,495 18 % Acquisition costs — 18 1,636 (18) (100) % (1,618) (99 %) Change in fair value of contingent consideration (2,193) (4,754) 2,875 2,561 (54) % (7,629) (265 %) Total operating expenses $ 214,096 $ 307,300 $ 154,316 $ (93,204) (30 %) $ 152,984 99 % Cost of product, rental, and service revenue In the year ended December 31, 2023, cost of product, rental, and service revenue decreased $11.4 million, or 11%, from the year ended December 31, 2022.
Costs and operating expenses Total costs and operating expenses for years ended December 31, 2024, 2023, and 2022 were comprised of the following: Year Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In thousands, except percentages) 2024 2023 2022 $ Change % Change $ Change % Change Cost of product, rental, and service revenue $ 28,583 $ 29,922 $ 29,328 $ (1,339) (4 %) $ 594 2 % General and administrative 40,541 43,264 33,255 (2,723) (6 %) 10,009 30 % Sales and marketing 9,610 12,709 11,672 (3,099) (24 %) 1,037 9 % Research and development 7,912 12,073 8,671 (4,161) (34 %) 3,402 39 % Intangible asset amortization 2,737 3,520 3,990 (783) (22 %) (470) (12 %) Change in fair value of contingent consideration — (2,193) (4,754) 2,193 100 % 2,561 54 % Total operating expenses $ 89,383 $ 99,295 $ 82,162 $ (9,912) (10 %) $ 17,133 21 % Cost of product, rental, and service revenue In the year ended December 31, 2024, cost of product, rental, and service revenue decreased $1.3 million, or 4%, from the year ended December 31, 2023.
Reflects the non-cash gain associated with our investment in Sexton due to the step-acquisition of the remaining shares of Sexton and subsequent consolidation of Sexton in our financial statements. 35 Table of Contents Income Tax (Expense) Benefit Income tax benefit for the years ended December 31, 2023, 2022, and 2021 was as follows: Year Ended December 31, 2023 vs. 2022 2022 vs. 2021 (In thousands, except percentages) 2023 2022 2021 $ Change % Change $ Change % Change Income tax (expense) benefit $ (169) $ 5,022 $ 20,118 $ (5,191) (103) % $ (15,096) (75 %) Effective tax rate — % 4 % 69 % The income tax benefit recognized in the year ended December 31, 2023 primarily related to losses generated in 2023.
For additional information, see Note 12 within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report. 39 Table of Contents Income Tax Benefit Income tax benefit for the years ended December 31, 2024, 2023, and 2022 was as follows: Year Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In thousands, except percentages) 2024 2023 2022 $ Change % Change $ Change % Change Income tax benefit $ 38 $ 24 $ 5,236 $ 14 58 % $ (5,212) (100 %) Effective tax rate — % — % 108 % The income tax benefit recognized in the year ended December 31, 2024 primarily related to losses generated in 2024.
We have in-house expertise in cryobiology and continue to capitalize on opportunities to maximize the value of our product platform for our extensive customer base through both organic growth innovations and acquisitions. Subsequent to the second quarter of 2023, we began to seek divestment of our Freezer Business from our current product portfolio.
We have in-house expertise in cryobiology and the broader CGT workflow, and continue to evaluate opportunities to maximize the value of our product platforms for our extensive customer base through organic growth innovations, partnerships, and acquisitions. Segment reporting Management views the Company's operations and makes decisions regarding how to allocate resources as one reportable segment and one reporting unit.
The increase in cash provided by financing activities compared to the prior year is primarily due to drawing $20 million on a term loan obtained on September 20, 2022, offset by payments on outstanding debt of $1.7 million and payments on financed insurance premiums of $1.4 million.
Financing activities In the year ended December 31, 2024, cash used by financing activities was $6.8 million. The use of cash in financing activities was primarily related to $9.0 million in payments on our Term Loan, equipment loans, and financed insurance premiums. This was offset by proceeds from financed insurance premiums of $2.1 million.
The remaining costs primarily relate to an increase of $1.4 million in severance related to the departure of the former CEO and other staff in addition to a reduction in headcount that occurred in the quarter ended September 30, 2023.
The increase was driven by higher costs related to the expansion of our corporate infrastructure, including an increased headcount resulting in a $1.2 million increase in salary expenses and a $1.9 million increase in stock compensation expenses. The departure of the former CEO during 2023 also increased severance expenses by $1.4 million.
The Company borrowed $20 million upon closing. As of December 31, 2023, the Company had not drawn additional funding outlined within the Loan Agreement. For additional information on terms, see Note 13: Long-term debt within the consolidated financial statements in Part II, Item 8 of this Annual Report.
For additional information on the divestiture of SciSafe, see Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report. On November 14, 2024, we consummated the CBS Divestiture. In connection with the closing of the transaction, we received net proceeds of $3.4 million.
Removed
For additional information regarding our ongoing initiative to divest the Freezer Business, see “Item 1A. Risk Factors” of this Annual Report for additional details. Segment reporting Management views the Company's operations and makes decisions regarding how to allocate resources as one reportable segment and one reporting unit.
Added
On April 17, 2024, the Company sold all of the issued and outstanding shares of common stock of Global Cooling to GCI Holdings pursuant to the Global Cooling Purchase Agreement. Upon the execution of the Global Cooling Purchase Agreement, the Global Cooling business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
Removed
Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
Added
See Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the divestiture. On November 12, 2024, the Company entered into the SciSafe Purchase Agreement with the Sci Safe Buyer for the sale by Seller of all of the issued and outstanding SciSafe Shares to SciSafe Buyer.
Removed
The Company also generates revenue from the leasing of our property and equipment, operating right-of-use assets, and evo cold chain systems to customers pursuant to service contracts or rental arrangements entered into with the customer.
Added
Upon the execution of the SciSafe Purchase Agreement, the SciSafe business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented. See Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the divestiture.
Removed
Business combinations Amounts paid for acquisitions are allocated to the tangible and intangible assets acquired and liabilities assumed, if any, based on their fair values at the dates of acquisition. This purchase price allocation process requires management to make significant estimates and assumptions with respect to intangible assets and deferred revenue obligations.
Added
On November 14, 2024, the Company entered into the CBS Purchase Agreement with CBS Buyer and CBS for the sale by the Company of all of the issued and outstanding CBS Shares to CBS Buyer.
Removed
The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions determined by management. Any excess of purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill.
Added
Upon the execution of the CBS Purchase Agreement, the CBS business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented. See Note 3: Discontinued operations within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report for further details regarding the divestiture.
Removed
While we use our best estimates and assumptions to accurately value assets acquired and liabilities assumed at the acquisition date as well as any contingent consideration, where applicable, our estimates are inherently uncertain and subject to refinement.
Added
For additional information on the Company's segment considerations, Note 16: Segment, customer, and geographic information within the Consolidated Financial Statements in Part II, Item 8 of this Annual Report. Critical accounting policies and estimates We have identified the policies and estimates below as being critical to our business operations and the understanding of our results of operations.
Removed
As a result, during the measurement period, which may be up to one year from the acquisition date, we record adjustments to the assets acquired and liabilities assumed with the corresponding offset to goodwill.
Added
All customers leasing shippers currently do so under rental arrangements for durations of one year or less, with each unit having the option to continue its rental arrangement on a month-to-month basis until returned to the Company beyond the initial rental period.
Removed
Upon conclusion of the measurement period or final determination of the values of assets acquired or liabilities assumed, whichever comes first, any subsequent adjustments are recorded to our Consolidated Statements of Operations.
Added
As of December 31, 2024, the Company had U.S. federal net operating loss (“NOL”) carryforwards of approximately $165.2 million, which is available to reduce future taxable income. Approximately $38.7 million of NOL will expire from 2025 through 2037, and approximately $126.5 million of NOL will be carried forward indefinitely.
Removed
The fair value of contingent consideration includes estimates and judgments made by management regarding the probability that future contingent payments will be made, the extent of royalties to be earned in excess of the defined minimum royalties, etc.
Added
Revenue Revenue for years ended December 31, 2024, 2023, and 2022 were comprised of the following: Year Ended December 31, 2024 vs. 2023 2023 vs. 2022 (In thousands, except percentages) 2024 2023 2022 $ Change % Change $ Change % Change Product revenue Cell processing $ 73,446 $ 65,772 $ 68,509 $ 7,674 12 % $ (2,737) (4 %) Evo and thaw 2,582 3,196 3,434 (614) (19 %) (238) (7 %) Service revenue Evo and thaw 160 349 73 (189) (54 %) 276 378 % Rental revenue Evo and thaw 6,066 6,538 4,223 (472) (7 %) 2,315 55 % Total revenue $ 82,254 $ 75,855 $ 76,239 $ 6,399 8 % $ (384) (1 %) Product revenue Total product revenue was $76.0 million for the year ended December 31, 2024, representing an increase of $7.1 million, or 10%, compared with the year ended December 31, 2023.
Removed
Management updates these estimates and the related fair value of contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a discount rate that captures the risk associated with the expected contingent payments.
Added
The increase in product revenue was primarily driven by the $7.7 million, or 12%, increase in cell processing products from an increase in customer demand when compared to the prior year.
Removed
To the extent our estimates change in the future regarding the likelihood of achieving these targets we may need to record material adjustments to our accrued contingent consideration. Changes in the fair value of contingent consideration are recorded in our Consolidated Statements of Operations.
Added
During the third and fourth quarters of 2023, we experienced a decrease in our revenues from our customers destocking inventory levels in addition to decreases in broader biotech funding that we did not experience during the year 36 Table of Contents ended December 31, 2024.
Removed
We use the income approach to determine the fair value of certain identifiable intangible assets including customer relationships and developed technology. This approach determines fair value by estimating after-tax cash flows attributable to these assets over their respective useful lives and then discounting these after-tax cash flows back to a present value.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

2 edited+2 added−4 removed2 unchanged
Biggest changeThe effects of a hypothetical 10% appreciation in the U.S. dollar from December 31, 2023 levels against the euro are as follows (in thousands): Decrease in translation of 2023 earnings into U.S. dollars $ 150 Decrease in translation of net assets of foreign subsidiaries $ 187 Interest rate risk Our exposure to market risk for changes in interest rates relates primarily to our investments in available-for-sale securities and our long-term debt.
Biggest changeFluctuations in foreign currency exchange rates have not had a material impact on our results of operations for the periods presented. 43 Table of Contents Interest rate risk Our exposure to market risk for changes in interest rates relates primarily to our investments in available-for-sale securities and our long-term debt.
For additional information about our available-for-sale securities and long-term debt, see Notes 4 and 13 to the Consolidated Financial statements in Part II, Item 8 of this Annual Report. 41 Table of Contents
For additional information about our available-for-sale securities and long-term debt, see Notes 5: Investments and 13: Long-term debt to the Consolidated Financial Statements in Part II, Item 8 of this Annual Report. 44 Table of Contents
Removed
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Foreign currency exchange risk The Company operates internationally, and thus is subject to potentially adverse movements in foreign currency exchange rates. Approximately 1% of the Company's consolidated net sales in the year ended December 31, 2023 were made in euros.
Added
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Foreign currency exchange risk The Company's sales are primarily denominated in the U.S. dollar. Accordingly, our sales are not generally impacted by foreign currency rate changes.
Removed
The Company is exposed to market risk primarily from foreign exchange rate fluctuations of the euro as compared to the U.S. dollar as the financial position and operating results of the Company's foreign operations are translated into U.S. dollars for consolidation. 40 Table of Contents Month-end exchange rates between the euro and the U.S. dollar, which have not been weighted for actual sales volume in the applicable months in the periods, were as follows: Year Ended December 31, 2023 2022 2021 High $ 1.11 $ 1.15 $ 1.24 Low $ 1.06 $ 0.95 $ 1.12 Average $ 1.08 $ 1.05 $ 1.18 The Company's exposure to foreign exchange rate fluctuations also arises from trade receivables and intercompany payables denominated in one currency in the financial statements, but receivable or payable in another currency.
Added
Any transactions denominated in a foreign currency, which were immaterial during the year ended December 31, 2024, incur gains or losses from the remeasurement and settlement of the balances and are reported in the Other income line item on the Consolidated Statements of Operations.
Removed
The Company does not enter into foreign currency forward contracts to reduce its exposure to foreign currency rate changes on forecasted intercompany sales transactions or on intercompany foreign currency denominated balance sheet positions. Foreign currency transaction gains and losses are included in "Other income" in the Consolidated Statements of Operations.
Removed
The effect of translating net assets of foreign subsidiaries into U.S. dollars are recorded on the Consolidated Balance Sheet as part of "Accumulated other comprehensive loss, net of taxes".

Other BLFS 10-K year-over-year comparisons