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BIOLIFE SOLUTIONS INC

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Business Summary

BioLife Solutions, Inc. operates as a life sciences company that develops, manufactures, and markets bioproduction products and services designed to improve quality and de-risk biologic manufacturing, distribution, and transportation in the cell and gene therapy (CGT) industry. According to the Alliance for Regenerative Medicine (ARM), there were over 1,900 ongoing clinical trials globally utilizing regenerative medicine at year-end 2025, with approximately $11.1 billion invested in the regenerative medicine market in 2025 and an expectation of continued regulatory approvals for CGTs during 2026. The company's products are used in basic and applied research and commercial manufacturing of biologic-based therapies, and the company currently operates as one bioproduction products and services business supporting several steps in the biologic material manufacturing and delivery process.

The company competes on the basis of value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies. Many competitors have greater financial and human resources, R&D, manufacturing, and marketing experience. The company believes its products offer significant advantages over in-house formulations or commercial generic biopreservation media, including time savings, more consistent and higher quality components, more rigorous quality control release testing, cost effectiveness, and improved preservation efficacy. A key differentiator of the proprietary HypoThermosol FRS and CryoStor formulations is the engineered optimization of key ionic component concentrations for low-temperature environments, in contrast to media optimized for normothermic body temperature.

The company generates revenue primarily through the sale of biopreservation media and cell processing tools. Product revenue is recognized at a point in time when control transfers to customers, which is upon shipment for substantially all transactions. Payment terms generally include a requirement of payment within 30 to 60 days. The company markets and sells products through direct sales and third-party distribution; in 2025, 2024, and 2023, sales to third-party distributors accounted for 34%, 34%, and 38% of revenue, respectively. The company's products integrate into several steps in customers' bioproduction workflow process for cell and gene therapies, and the company leverages its relationships with leading CGT companies to cross-sell other parts of the portfolio.

The company's bioproduction products and services are comprised of one revenue line containing three main offerings: cell processing and other products, which includes biopreservation media, human platelet lysate media (hPL), cryogenic and ultralow temperature containers, automated cell-processing fill machines, and automated thawing devices. The proprietary biopreservation media products, HypoThermosol FRS and CryoStor Freeze Media, are formulated to mitigate preservation-induced, delayed-onset cell damage and death. These media are serum-free, protein-free, fully defined, and manufactured under current Good Manufacturing Practices (cGMP). The company's US FDA Type II Master File applicable to its biopreservation products has been cross referenced over 750 times by customers, and the company believes its cell processing products are utilized in several hundred active clinical trials worldwide. During the years ended December 31, 2025, 2024, and 2023, the company derived approximately 82%, 80%, and 82% of its revenue from CryoStor products, respectively.

The ThawSTAR product line includes thawing products that control the temperature and timing of the thawing process of biologic material. These customizable, automated, water-free thawing products use algorithmic programmed heating plates to consistently bring biologic material from a frozen state to a liquid state, helping reduce damage during temperature transition and reducing risk of contamination versus using a traditional water bath. The Sexton cell processing product line includes human platelet lysates for cell expansion, CellSeal closed systems that are purpose-built rigid containers used in CGT, 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.

On October 6, 2025, the company entered into an agreement to sell SAVSU Cleo Technologies, LLC, receiving net proceeds of $23.9 million , including a $2.5 million indemnity holdback. On April 4, 2025, the company acquired the remaining 90% of PanTHERA CryoSolutions Inc. for an aggregate purchase price of $16.8 million , which included $11.5 million in cash and 213,360 shares of common stock, with the PanTHERA Sellers eligible to receive up to $7.2 million in cash or equivalent shares over a three-year earnout period. On November 14, 2024, the company completed the CBS Divestiture, receiving net proceeds of $3.4 million . On November 12, 2024, the company completed the SciSafe Divestiture, receiving net proceeds of $71.3 million . On April 17, 2024, the company completed the Global Cooling Divestiture, providing $6.7 million in cash funding to effectuate the transaction. The company also recognized $1.3 million in stock compensation expense in connection with the acceleration of unvested shares for SAVSU employees, $2.0 million for CBS employees, $4.0 million for SciSafe employees, and $3.2 million for Global Cooling employees.

Total revenue for the year ended December 31, 2025 was $96.2 million , representing an increase of $21.6 million , or 29% , compared with the year ended December 31, 2024. Gross margin was 65% for 2025 compared to 67% for 2024. Operating loss was $16.6 million for 2025 compared to $4.5 million for 2024. Net loss from continuing operations was $12.1 million for 2025 compared to $8.8 million for 2024. Total cash, cash equivalents, and available-for-sale securities were $120.2 million as of December 31, 2025, compared to $105.4 million as of December 31, 2024.

Business Outlook

The company's strategy is 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. The company leverages its numerous relationships with leading cell and gene therapy companies that use its offering of bioproduction products and services to cross-sell other parts of the portfolio. The company believes its relationships and reputation could enable it to drive further incremental revenue growth through the sale of additional products and services to a captive customer base. The company continues to evaluate opportunities to maximize the value of its product platforms for its extensive customer base through organic growth innovations, partnerships, and acquisitions.

The PanTHERA Transaction, completed on April 4, 2025, provides the company with PanTHERA's patented Ice Recrystallization Inhibitor (IRI) GEN 2 cryopreservation technology that is expected to ultimately enhance the company's core capabilities in biopreservation and within the CGT market upon achievement of commercial viability. The PanTHERA Sellers are eligible to receive up to $7.2 million in cash or equivalent shares over a three-year earnout period upon the achievement of certain revenue targets based on the company's earnings derived from the acquired IRI GEN 2 cryopreservation technology in addition to the achievement of an operational milestone within the first year of the earnout period. As of December 31, 2025, management determined that the probability of achieving the outlined revenue and operational targets was remote, and no earnout consideration has been recognized.

Gross margin was 65% for the year ended December 31, 2025, compared to 67% for 2024. The decrease in gross margin was attributed to an increase in costs of materials and overhead due to a less favorable product mix. Cost of revenue increased $9.5 million , or 39% , driven by a 29% increase in overall sales volume in addition to lower yields on biopreservation bags and increased scrap as a percentage of revenue due to an inventory reserve in Q3 2025 and an increased rate of disposal of expired raw material and finished goods inventory.

The company maintains and operates two independent cGMP clean room production suites for manufacturing sterile biopreservation media products in Bothell, Washington, and one cGMP clean room production suite for manufacturing hPL media in Indianapolis, Indiana. The company's ThawSTAR automated, water-free thawing products are produced by a contract manufacturing organization based in the United States. The company seeks to manage single-source supplier risk by regularly assessing the quality and capacity of suppliers, implementing supply and quality agreements where appropriate, and actively managing lead times and inventory levels of sourced components. For certain components without a secondary supplier, the company estimates that it would take up to six months to find and qualify a second source.

The company's 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. R&D expense increased $2.8 million , or 59% , in the year ended December 31, 2025 compared to 2024, primarily due to increases in personnel expenses including $1.1 million in salaries from increased headcount, $0.9 million in stock-based compensation, and $0.5 million in bonus expenses. Capital expenditures were $9.5 million for the year ended December 31, 2025. The company did not repurchase any shares of common stock during the period and has never paid cash dividends on its common stock, with no expectation to pay dividends in the foreseeable future.

The company faces structural headwinds including its dependence on a limited number of customers and products in a limited number of market sectors. During the years ended December 31, 2025, 2024, and 2023, the company derived approximately 29%, 32%, and 29% of its revenue from three customers, respectively. The company also depends on single-source and sole-source suppliers, and disruptions in the supply chain could adversely affect its ability to manufacture and deliver products. The company is subject to risks associated with tariffs and other trade policies, noting that throughout 2025 and during the first quarter of 2026, there have been significant tariffs imposed on imported goods within the United States with indications that future tariffs are likely to be imposed.

The company faces constraints from macroeconomic factors, geopolitical unrest, inflation, changes in interest and foreign currency exchange rates, tariffs and retaliatory measures, war and other military conflict, and other risks and uncertainties that have in the past and may continue to cause logistical challenges, increased input costs, or create constraints for suppliers, distributors, or customers. During the year ended December 31, 2025, approximately 20% of revenue was derived from customers located outside the United States, primarily in Europe, Middle East, and Africa. The company also faces risks related to public health crises, noting that the COVID-19 pandemic created significant volatility, uncertainty, and economic disruption which had an adverse effect on its business operations.

Risk Factors

The company depends on a limited number of customers and products in a limited number of market sectors; during the years ended December 31, 2025, 2024, and 2023, the company derived approximately 29%, 32%, and 29% of its revenue from three customers, respectively, and approximately 82%, 80%, and 82% of its revenue from CryoStor products, respectively. The company is dependent on single-source and sole-source suppliers, and for certain components without a secondary supplier, it estimates that it would take up to six months to find and qualify a second source. As of December 31, 2025, the net carrying value of goodwill and other intangible assets totaled $212.8 million , and any impairment could result in significant charges against earnings. The company has accumulated significant NOL carryforwards of approximately $168.4 million as of December 31, 2025, which may be subject to annual limitations under Section 382 of the Internal Revenue Code if an ownership change occurs. The company's recent divestitures expose it to ongoing risks, including retained liabilities and indemnification obligations; for example, the company remains liable for one of SciSafe's operating leases with outstanding minimum lease payments of approximately $2.2 million terminating in 2031, and is required to indemnify Global Cooling for certain preexisting legal contingencies, including a claim that was fully settled for $2.5 million in the first quarter of 2026.

Management Priorities

Management's message emphasizes the company's transformation through a series of strategic divestitures and acquisitions completed during the period, including the sale of SAVSU, CBS, SciSafe, and Global Cooling, and the acquisition of PanTHERA, all aimed at streamlining the product portfolio to focus on proprietary high-margin cell processing and other bioproduction products. The company's strategy is centered 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, with a commitment to supporting customers with strong customer service and applications expertise. Management highlights the company's belief that its relationships and reputation could enable it to drive further incremental revenue growth through the sale of additional products and services to a captive customer base, and that the company continues to evaluate opportunities to maximize the value of its product platforms through organic growth innovations, partnerships, and acquisitions.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 7, MD&A — Liquidity and Capital Resources
  2. [2] Item 7, MD&A — Liquidity and Capital Resources
  3. [3] Item 1, Business — Recent divestitures and acquisitions
  4. [4] Item 7, MD&A — Liquidity and Capital Resources
  5. [5] Item 7, MD&A — Liquidity and Capital Resources
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  10. [10] Item 7, MD&A — Liquidity and Capital Resources
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  13. [13] Item 7, MD&A — Liquidity and Capital Resources
  14. [14] Item 7, MD&A — Liquidity and Capital Resources
  15. [15] Item 7, MD&A — Results of Operations
  16. [16] Item 7, MD&A — Results of Operations
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  20. [20] Item 8, Consolidated Statements of Operations
  21. [21] Item 8, Consolidated Statements of Operations
  22. [22] Item 8, Consolidated Statements of Operations
  23. [23] Item 8, Consolidated Statements of Operations
  24. [24] Item 7, MD&A — Liquidity and Capital Resources
  25. [25] Item 7, MD&A — Liquidity and Capital Resources
  26. [26] Item 7, MD&A — Liquidity and Capital Resources
  27. [27] Item 7, MD&A — Results of Operations
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  36. [36] Item 7, MD&A — Results of Operations
  37. [37] Item 8, Consolidated Statements of Cash Flows
  38. [38] Item 1A, Risk Factors
  39. [39] Item 8, Note 14 — Income Taxes
  40. [40] Item 8, Note 3 — Discontinued Operations
  41. [41] Item 8, Note 3 — Discontinued Operations
  42. [42] Item 8, Consolidated Statements of Operations
  43. [43] Item 8, Consolidated Statements of Operations
  44. [44] Item 8, Consolidated Statements of Operations
  45. [45] Item 8, Consolidated Statements of Operations
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  49. [49] Item 8, Consolidated Statements of Operations
  50. [50] Item 8, Consolidated Statements of Operations
  51. [51] Item 8, Consolidated Statements of Operations
  52. [52] Item 8, Consolidated Statements of Operations
  53. [53] Item 8, Consolidated Statements of Operations
  54. [54] Item 7, MD&A — Results of Operations
  55. [55] Item 7, MD&A — Results of Operations
  56. [56] Item 7, MD&A — Results of Operations
  57. [57] Item 7, MD&A — Liquidity and Capital Resources
  58. [58] Item 7, MD&A — Liquidity and Capital Resources
  59. [59] Item 8, Consolidated Statements of Operations
  60. [60] Item 8, Consolidated Statements of Cash Flows
  61. [61] Item 8, Consolidated Statements of Cash Flows
  62. [62] Item 8, Consolidated Balance Sheets
  63. [63] Item 8, Consolidated Balance Sheets
  64. [64] Item 7, MD&A — Results of Operations
  65. [65] Item 7, MD&A — Results of Operations

Analysis on 6/21/2026