2023-03-28 12:08:15 ET
Summary
- BioLife Solutions, a leading provider of bioproduction tools and services, is poised for growth as the demand for biologics and regenerative medicine increases.
- CryoStor and HypoThermosol have shown significant improvement to the post-preservation viability of biologic materials during manufacturing, storage, and distribution.
- BioLife Solutions recently announced the launch of Ultraguard, a ULT freezer solution for ultra-low temperature protection, addressing limitations and risks associated with dry ice supply and cost.
- With the increased demand for increasingly complex biologic storage needs, ULT protection is now essential for the life science industry.
BioLife Solutions (BLFS) provides bioproduction tools designed for broad biopharma markets. With its industry-leading products, dedication to innovation and regulatory compliance, and commitment to ensuring the quality, safety, and efficacy of its products, BioLife presents a solid bullish case for those looking to invest in the biopharma industry.
Financials and Balance Sheet Analysis
BioLife recently disclosed its financial results for the fourth quarter of 2022, showcasing solid revenue growth and a better gross margin. In Q4 2022, the company brought in $44.3 million in total revenue, representing a 19% increase from $37.3 million during the same quarter of the previous year. Additionally, the company experienced a 36% growth in its yearly revenue, reaching $161.8 million in comparison to 2021, with an outstanding organic revenue growth of 38%.
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In Q4 2022, the revenue from the company's Cell Processing platform experienced a significant 36% surge to $20.2 million, while Biopreservation experienced a 35% increase. The revenue from the Freezers and Thaw Systems platform modestly grew by 5% to $17.4 million, and the Storage and Storage Services platform saw a 14% rise to $6.7 million. The robust financial performance of BioLife is attributable to a blend of elements, such as the strategic acquisitions of Global Cooling and Sexton Biotechnologies , which contributed to the firm's overall expansion.
In Q4 2022, BioLife's gross margin saw significant growth as well, with a GAAP gross margin of 30% in contrast to 13% in Q4 2021. Additionally, the adjusted gross margin reached 32% compared to 17% in Q4 2021, primarily due to reduced warranty expenditures. For the entire year, BioLife's gross margin (GAAP) was 30%, as opposed to 27% in 2021. The non-GAAP adjusted gross margin for 2022 was 33%, in comparison to 32% in 2021. The company's diminished warranty expenses have contributed to its improved gross margin and demonstrate its commitment to cost reduction and operational efficiency enhancement.
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BioLife's GAAP operating expenses for Q4 2022 increased to $93.5 million, up from $54.9 million during the same quarter of 2021. This was mostly due to a non-cash impairment charge of $40.5 million associated with acquired intangible assets of Global Cooling. For the full year, BioLife's GAAP operating expenses totaled $307.3 million compared with $154.3 million in 2021. This rise was mainly attributed to non-cash impairment charges of $110.4 million connected to purchased intangible assets of Global Cooling and Sexton Biotechnologies, as well as personnel costs.
In terms of net losses, BioLife recorded a GAAP net loss of $49.2 million in Q4 2022, compared to $14.8 million during the same quarter of the preceding year. However, the company's non-GAAP adjusted net loss for Q4 2022 totaled $8.2 million as opposed to $12 million in Q4 2021. This indicates financial performance had improved despite increasing GAAP losses, a trend that should continue given the increased growth across all platforms that has been seen recently.
Current Products
BioLife offers various products that cater to a range of needs all their platforms address. CryoStor is a series of proprietary freeze media products designed for cryopreservation of biologics. It significantly reduces post-preservation apoptosis and necrosis in various cell types compared to other formulations. HypoThermosol is a series of proprietary shipping and storage media products for hypothermic preservation of biologics at 2 to 8°C. It is designed to extend shelf life and improves post-preservation viability to a significant degree.
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BioLife also provides Stirling Ultracold , a range of secure storage solutions that use patented Stirling engine technology to provide ultra-low temperature and cryogenic freezing without the use of compressors or liquid nitrogen. These freezers are suitable for storing biologics such as vaccines, cell therapies, gene therapies, biobanking samples, and clinical trial materials. The company's SciSafe range of on-site biologic storage services offers secure, compliant, and scalable solutions for biopharma customers, with customized storage solutions for various temperature ranges, sample types, and volumes, as well as inventory management, sample retrieval, transport coordination, regulatory compliance, and quality assurance services.
ThawSTAR is a series of automated water-free precision thawing systems that use innovative technology to enable precise and repeatable thawing without the use of water baths. ThawSTAR systems are designed to reduce variability, contamination risk, and cell damage during thawing. Overall, BioLife Solutions' product offerings and expertise in bioproduction make it an attractive option for companies looking for innovative solutions in the life sciences industry.
Introduction of Ultraguard ULT Solution
BioLife has now introduced Ultraguard, a safe and eco-friendly -70°C phase change material ((PCM)) designed for ultra-low temperature (ULT) protection. The product targets two primary user applications: temperature maintenance when ULT freezers experience power outages and benchtop biological material storage as an alternative to dry ice, addressing concerns or risks related to availability, expense, or safety. Ultraguard's efficacy has been successfully verified through beta testing with key BioLife clients, including a leading logistics provider and a prominent international health organization.
ULT protection has become a vital requirement in the life sciences sector, and preserving the cold chain remains a challenge due to the increasing intricacy of biological storage and transportation needs. The product comes in the form of a user-friendly plastic container or "brick" that can be "charged" or converted from liquid to frozen solid by cooling below -80°C, thereby storing the necessary cooling energy. This innovation marks a significant milestone for BioLife Solutions, as it continues to create new opportunities and offer added value to its life sciences clientele through risk reduction benefits.
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As more logistics providers collaborate with BioLife, the potential markets for Ultraguard are expected to expand, encompassing the worldwide installed base of ULT freezers and global dry ice consumption for biological material storage and transportation.
CryoStor Some has Key Drawbacks
BioLife Solutions' primary offering, CryoStor, is formulated with DMSO, a permeating cryoprotective agent that mitigates ice formation damage. Compared to most isotonic and extracellular formulations, CryoStor has been shown to reduce post-preservation apoptosis and necrosis across various cell types.
The mechanism behind the successful outcomes achieved with CryoStor is based on its intracellular-like composition , which resembles that of the cytosol with regards to osmolarity and other properties. This formulation helps preserve cell membrane integrity, protect against osmotic stress, and fight reactive oxygen species during freezing and thawing processes. The inclusion of DMSO also serves as a colligative agent , reducing the freezing point of the solution thereby decreasing ice crystal formation; it further penetrates the cell membrane and stabilizes internal structures and molecules.
Given this, there are potential risks or challenges associated with using CryoStor products. These are primarily associated with DMSO toxicity and varying freezing and thawing protocols. As DMSO can have toxic effects on cells and tissues, the optimal concentration and exposure time must be established for different cell and tissue types in order to minimize possible harm and maximize protections.
In addition, the efficacy and safety of CryoStor products rely on correct fulfillment of specific freezing and thawing protocols per cell or tissue type. Factors such as cooling rate, warming rate, storage temperature, storage duration, sample volume, sample container, and post-thaw processing all affect cryopreservation results; hence, standardization and validation of these protocols are crucial for consistent and reproducible outcomes. Lastly, clinical applications of CryoStor products for cryopreservation of biologics may face regulatory and ethical obstacles between different jurisdictions.
Strengths Over the Competition
BioLife faces competition from several companies, each with their own unique product offerings. For instance, Thermo Fisher Scientific (TMO) offers a range of cryopreservation media, including its Gibco Recovery Cell Culture Freezing Medium, which competes with BioLife's CryoStor series. While Thermo Fisher's product claims to protect cells during freezing and thawing, Biolife's CryoStor has been demonstrated to reduce post-preservation apoptosis and necrosis in various cell types more effectively than commercial and home-brew isotonic and extracellular formulations. This advantage makes CryoStor a superior choice for preserving the viability and functionality of biologics.
Another competitor is BioLife Solutions' HypoThermosol, which goes up against products like Bel-Art's KoolTemp GTS and Sigma-Aldrich's Celsior solution. These competitors aim to provide hypothermic preservation of biologics at 2 to 8°C, but HypoThermosol has proven its ability to extend shelf life and improve post-preservation viability and function in various cell types more effectively than the alternatives. This gives HypoThermosol a competitive edge in terms of both efficacy and reliability.
When it comes to ultra-low temperature and cryogenic storage solutions, BioLife's Stirling Ultracold competes with companies like Eppendorf and Thermo Fisher Scientific, who offer traditional compressor-based freezers and liquid nitrogen-based systems. However, Stirling Ultracold's patented Stirling engine technology eliminates the need for compressors or liquid nitrogen, resulting in reduced operational costs and environmental impact. This innovation, along with the system's energy efficiency and temperature stability, sets BioLife's storage solutions apart from the competition.
In terms of automated thawing systems, BioLife's ThawSTAR faces competition from products like Helmer Scientific's ThawSTAR AT4 and Thermo Fisher's ThermoGrid. While these competitors offer automated thawing, BioLife's ThawSTAR stands out due to its water-free precision thawing technology, which minimizes variability, contamination risk, and cell damage during the thawing process. This ensures the highest quality results and preservation of biological samples.
Final Outlook
The outlook for BioLife Solutions appears to be highly promising. The company's innovative and high-quality products have positioned it as a leader in the bioproduction tools and services industry, which is projected to experience significant growth in the coming years. BioLife has demonstrated consistent revenue growth and profitability, driven by increasing demand for its products and services from the cell and gene therapy and broader biopharma markets. Furthermore, the company's improving balance sheet and financial discipline provide a solid foundation for future growth.
Going forward, BioLife Solutions is well-positioned to benefit from the widening market for cell and gene therapies. Due to its strong product range and sound financial situation, BioLife looks set to continue on its successful growth trajectory in the future.
For further details see:
BioLife Solutions: Capitalizing On The Future Of Biopreservation