BIOLIFE SOLUTIONS INC (BLFS) Business
This page reproduces the company's own Item 1 Business text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
Informational only - not investment advice. See Disclaimer.
ITEM 1. BUSINESS
The following discussion of our business contains forward-looking statements that involve risks and uncertainties (see the section entitled “Forward-Looking Statements” herein). Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those factors set forth under “Risk Factors” and elsewhere in this Form 10-K.
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. 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. Our portfolio of tools and services focuses on biopreservation media and cell processing products. 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.
Recent divestitures and acquisitions
On October 6, 2025, the Company entered into a Limited Liability Company Membership Interest Purchase Agreement (the “SAVSU Purchase Agreement”), by and between the Company and Peli BioThermal LLC, a Delaware limited liability company (“SAVSU Buyer”), for the sale by the Company of all of the issued and outstanding limited liability company membership interests (the “SAVSU Interests”) of SAVSU Cleo Technologies, LLC, a Delaware limited liability company ("SAVSU"), to SAVSU Buyer (the “SAVSU Divestiture”). SAVSU contained our evo cloud connected “smart” shipping container products that provided passive storage and transport for temperature-sensitive biologics and pharmaceuticals. Upon the execution of the SAVSU Purchase Agreement, the SAVSU business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
On April 4, 2025, pursuant to a Stock Purchase Agreement (the “PanTHERA Purchase Agreement”), by and among the Company, Casdin Partners Master Fund L.P. and each other person listed on Schedule A thereto (the “PanTHERA Sellers”), 2699979 Alberta LTD., an Alberta corporation and a wholly owned subsidiary of the Company (“PanTHERA Buyer Sub”), PanTHERA CryoSolutions Inc., an Alberta corporation (“PanTHERA”) and Dr. Jason Acker, solely in his capacity as Sellers’ Representative, the Company acquired the remaining 90% of the issued and outstanding shares of common stock of PanTHERA not owned by the Company from the PanTHERA Sellers (the “PanTHERA Transaction”). PanTHERA contains a patented Ice Recrystallization Inhibitor (“IRI”) GEN 2 cryopreservation technology that we expect to ultimately enhance the Company’s core capabilities in biopreservation and within the CGT market upon achievement of commercial viability.
On November 14, 2024, the Company entered into a Stock Purchase Agreement (the “CBS Purchase Agreement”), by and among the Company, Standex International Corporation, a Delaware corporation (“CBS Buyer”), and Arctic Solutions, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (doing business as Custom Biogenic Systems, or “CBS”), for the sale by the Company of all of the issued and outstanding shares of common stock (the “CBS Shares”) of CBS to CBS Buyer (the “CBS Divestiture”). CBS contained our LN2 cryogenic freezers and other accessory products utilizing a dry storage method. 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.
On November 12, 2024, the Company entered into a Stock Purchase Agreement (the “SciSafe Purchase Agreement”), by and among the Company, Subzero Purchaser Corp., a Delaware corporation (“SciSafe Buyer”), SciSafe, Inc., a Delaware corporation and an indirect, wholly owned subsidiary of the Company (“Seller”), and SciSafe, Inc., a New Jersey corporation and an indirect wholly owned subsidiary of the Company (“SciSafe”), for the sale by Seller of all of the issued and outstanding shares of common stock (the “SciSafe Shares”) of SciSafe to SciSafe Buyer (the “SciSafe Divestiture”). SciSafe contained our biological and pharmaceutical storage and cold chain logistics services. Upon the execution of the
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SciSafe Purchase Agreement, the SciSafe business is presented in the accompanying Consolidated Financial Statements as a discontinued operation for all periods presented.
On April 17, 2024, the Company sold all of the issued and outstanding shares of common stock of Global Cooling, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Global Cooling”), to GCI Holdings Company, LLC, an Ohio limited liability company (“GCI Holdings”) pursuant to a Stock Purchase Agreement, dated April 17, 2024 (the “Global Cooling Purchase Agreement”), by and between the Company and GCI Holdings (the “Global Cooling Divestiture”). Global Cooling contained our portfolio of ultra-low temperature freezers. 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.
The Company is presenting SAVSU, CBS, SciSafe, and Global Cooling within this Annual Report as discontinued operations for all periods presented within the Consolidated Balance Sheets and Consolidated Statements of Operations. The Consolidated 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. 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.
Our products
Our bioproduction products and services are comprised of one revenue line that contains three main offerings:
•Cell processing and other products
◦Biopreservation media
◦Human platelet lysate media (“hPL”), cryogenic and ultralow temperature containers, and automated cell-processing fill machines
◦Automated thawing devices
Cell processing
Biopreservation media
Our proprietary biopreservation media products, HypoThermosol® FRS and CryoStor® Freeze Media, are formulated to mitigate preservation-induced, delayed-onset cell damage and death which result when cells and tissues are subjected to reduced temperatures. Our technology can provide our CGT customers with significant shelf-life extension of biologic source material and final cell products, and can also greatly improve post-preservation cell and tissue viability and function. Our biopreservation media are serum-free, protein-free, fully defined, and manufactured under current Good Manufacturing Practices ("cGMP"). We strive to source wherever possible the highest available grade, Multi-compendial raw materials. 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.
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. Limited stability is especially critical in the CGT field, where harvested cells and tissues will lose viability over time if not maintained appropriately at normothermic body temperature (37ºC) or stored in a hypothermic or cryogenic state in an effective preservation medium.
Chilling (hypothermia) is used to reduce metabolism and delay degradation of harvested cells and tissues. However, subjecting biologic material to hypothermic or cryogenic environments and subsequently rewarming them may also induce damaging molecular stress and structural changes. Although cooling successfully reduces metabolism (i.e., lowers demand for energy), various levels of cellular damage and death occur when using suboptimal methods. Biopreservation media can mitigate the damage from exposure to hypothermic or cryogenic temperatures and subsequent rewarming.
Traditional biopreservation media range from simple “balanced salt” (electrolyte) formulations to complex mixtures of electrolytes, energy substrates such as sugars, osmotic buffering agents, and antibiotics. The resulting limited stability from
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the use of these traditional biopreservation media formulations is a significant shortcoming that our optimized proprietary products address with great success.
Our scientific research activities over the last 20+ years enabled a detailed understanding of the molecular basis for the hypothermic and cryogenic (low-temperature induced) damage/destruction of cells through apoptosis and necrosis. This research led directly to the development of our HypoThermosol FRS and CryoStor technologies. Our proprietary biopreservation media products are specifically formulated to:
•Minimize cell and tissue swelling
•Reduce free radical levels upon formation
•Maintain appropriate low temperature ionic balances
•Provide regenerative, high-energy substrates to stimulate recovery upon warming
•Avoid the creation of an acidic state (acidosis)
•Inhibit the onset of apoptosis and necrosis
A key feature of our biopreservation media products is their “fully-defined” profile. All of our cGMP products are serum-free, protein-free and are formulated and filled using aseptic processing. We strive to use USP/Multi-compendial grade or the highest quality available synthetic components. All of these features benefit prospective customers by facilitating the qualification process required to incorporate our products into their regulatory filings.
Competing biopreservation media products are often formulated with isotonic media cocktails, animal serum, and potentially a single sugar or human protein. A key differentiator of our proprietary HypoThermosol FRS and CryoStor formulations is the engineered optimization of the key ionic component concentrations for low-temperature environments. This is in contrast to media optimized for normothermic body temperature (around 37°C), as found in culture media or saline-based isotonic formulas. 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. We believe that our products offer significant advantages over in-house ("home brew") formulations or commercial “generic” biopreservation media. These advantages include time savings, more consistent and higher quality of components, more rigorous quality control release testing, cost effectiveness, and improved preservation efficacy.
The results of independent testing demonstrate that our biopreservation media products significantly extend shelf-life and improve cell and tissue post-thaw viability and function. Our products have demonstrated improved biopreservation outcomes, including greatly extended shelf-life and post-thaw viability and yield across a broad array of cell and tissue types.
Human platelet lysate media, cryogenic vials and automated cell-processing fill machines
Our bioproduction products portfolio includes human platelet lysates for cell expansion, which reduces risk and improves downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal® closed systems that are purpose-built rigid containers used in CGT that can be filled manually or with high throughput systems, CryoCase™ cryo-compatible transparent rigid containers designed for closed-system fill and retrieval, and automated cell processing machines that bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination.
Automated thawing devices
The ThawSTAR® line includes thawing products that control the temperature and timing of the thawing process of biologic material. Our customizable, automated, water-free thawing products use algorithmic programmed heating plates to consistently bring biologic material from a frozen state to a liquid state in a controlled and consistent manner, helping reduce damage during the temperature transition while delivering critical process consistency across cell batches. Use of ThawSTAR products can also reduce risk of contamination versus using a traditional water bath.
Our market opportunity
The CGT market has been rapidly expanding, treating diseases once thought incurable. According to the Alliance for Regenerative Medicine (“ARM”), “2026 State of the Industry Briefing” there were over 1,900 ongoing clinical trials
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globally utilizing regenerative medicine at year-end 2025. Additionally, ARM reported an expected $2.0 billion in revenues over the next five years from recently developed and FDA approved CGT therapies, with continued investment in CGT development from the world's largest biopharma companies throughout 2025. ARM also reported there was approximately $11.1 billion invested in the regenerative medicine market in 2025, with an expectation of continued regulatory approvals for CGTs during 2026.
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. We believe we are well positioned to address many of the unique manufacturing challenges in the process of delivering CGTs.
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 and thawing under controlled conditions.
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 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. Over the last several years, we have built a
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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. 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.
Business Operations
Research and development
Our research and development activities are focused on evaluating new, potentially disruptive technologies which may add value throughout the cell and gene therapy manufacturing and delivery workflow. We routinely assess and analyze the strengths and weaknesses of competitive and adjacent products, and are engaged in business development discussions on an ongoing basis. We strive to continue to anticipate customer needs in providing enabling technologies in the CGT space.
Sales and marketing
We market and sell our products through direct sales and third-party distribution. 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 regional distributors under non-exclusive agreements. In 2025, 2024, and 2023, sales to third-party distributors accounted for 34%, 34%, and 38% of our revenue, respectively.
The following table represents the Company’s total revenue by geographic area (based on the location of the customer):
| Years Ended December 31, | ||||||||
|---|---|---|---|---|---|---|---|---|
| Revenue by customers’ geographic locations | 2025 | 2024 | 2023 | |||||
| United States | 80 | % | 75 | % | 81 | % | ||
| Europe, Middle East, Africa (EMEA) | 14 | % | 19 | % | 12 | % | ||
| Other | 6 | % | 6 | % | 7 | % | ||
| Total revenue | 100 | % | 100 | % | 100 | % |
Manufacturing
Cell processing – We maintain and operate two independent cGMP clean room production suites for manufacturing sterile biopreservation media products in Bothell, Washington. Our quality management system (“QMS”) in Bothell is certified to the ISO 13485:2016 standard. Our QMS takes guidance from applicable sections of 21 CFR Part 820 – Quality System Regulation for Good Manufacturing Practice of medical devices, 21 CFR Parts 210 and 211 – cGMP for Finished Pharmaceuticals, FDA Guidance – Sterile Drug Products, Volume 4, EU Guidelines Annex 1 – Manufacture of Sterile Medicinal Products, ISO 13408 – Aseptic Processing of Healthcare Products, and ISO 14644 – Clean Rooms and Associated Controlled Environments.
We also maintain and operate one cGMP clean room production suite for manufacturing hPL media in Indianapolis, Indiana. Our QMS in Indianapolis is certified to the ISO 9001:2015 standard. Our QMS takes guidance from applicable sections of 21 CFR Part 820 – Quality System Regulation for Good Manufacturing Practice of medical devices, 21 CFR Parts 210 and 211 – cGMP for Finished Pharmaceuticals, Volume 4, EU Guidelines Annex 2 – Manufacture of Biological active substances and Medicinal Products for Human Use and ISO 14644 – Clean Rooms and Associated Controlled Environments.
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 customer and quality agreements, we are required to notify customers of any changes to our raw materials. For certain components without a secondary supplier, we estimate that it would take up to six months to find and qualify a second source. Order quantities and lead times for externally sourced components are based on our
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forecasts, which are derived from historical demand and anticipated future demand. Lead times for components may vary depending on the size of the order, specific supplier requirements, and current market demand for the materials and parts.
We practice continuous improvement based on routine internal audits through our own monitoring of process outputs, external feedback, and audits performed by our partners and customers. 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 contract manufacturing organization ("CMO") based in the United States. We believe this CMO has the skills, experience and capacity needed to meet our quality standards and demand expectations for the product line. We estimate that it would take up to six months to find and qualify an alternative CMO. To date, we have not experienced significant difficulties in obtaining our automated thaw products from our CMO.
Product regulatory status
Our products are not subject to any specific FDA or other international marketing regulations for drugs, devices, or biologics. We are not required to sponsor formal prospective, controlled clinical trials in order to establish safety and efficacy. However, to support our current and prospective clinical customers, we manufacture and release our products in compliance with cGMP and other relevant quality standards.
To assist customers with their regulatory applications, we maintain Type II Master Files at the FDA for CryoStor, HypoThermosol FRS, BloodStor 27, Stemulate, nLiven PR, T-Liven PR, CellSeal Closed System containers, and our Cell Thawing Media products, which provide the FDA with information regarding our manufacturing facility and process, our quality system, stability and safety, and any additional testing that has been performed. 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. We have also obtained certain trademarks and tradenames for our products to distinguish our genuine products from our competitors’ products and we maintain certain details about our processes, products, and strategies as trade secrets. While we believe that the protection of patents and trademarks is important to our business, we also rely on a combination of trade secrets, nondisclosure and confidentiality agreements, scientific expertise, and continuing technological innovation to maintain our competitive position. Despite these precautions, it may be possible for unauthorized third parties to copy certain aspects of our products and/or to obtain and use information that we regard as proprietary (see Part I, “Item 1A. Risk Factors” in this Annual Report for additional details). The laws of some foreign countries in which we sell our products do not protect our proprietary rights to the same extent as do the laws of the United States.
| Issued Patents | Patents Applied For | Registered Trademarks | |||||
|---|---|---|---|---|---|---|---|
| Cell processing and other products | 87 | 83 | 45 |
Competition
Our bioproduction products and services compete on the basis of value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies. 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. They may undertake their own development of products that are substantially similar to or compete with our products, and they may succeed in developing products that are more effective or less costly than any that we may develop. These competitors may also prove to be more successful in their production, marketing and commercialization activities. 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.
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Human capital
We view our team members as the key to our success. As of December 31, 2025, we had 155 full-time team members and no part-time team members. 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. 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.
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. 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. 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.
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. 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.
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.
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. 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.
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. 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.
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 information contained on or accessible through our website is not part of this Annual Report on Form 10-K and is not incorporated in any manner into this Annual Report. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act, are available free of charge on our website as soon as reasonably practicable after we electronically file such reports with, or furnish
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those reports to, the Securities and Exchange Commission (the “SEC”). 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.