BOTHELL, Wash., July 13, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and related cloud hosted biologistics cold chain management app for smart shippers today announced preliminary revenue of $1.5 million for the second quarter of 2015.
Proprietary products revenue was $1.4 million in the second quarter of 2015, an increase of 33% over the same period in 2014. For the first six months of 2015, proprietary products revenue increased 32% as compared to last year.
Second quarter revenue growth drivers include increased sales of CryoStor and HypoThermosol biopreservation media to the regenerative medicine segment and continued strong product demand from BioLife's indirect sales channel, where the Company's products are distributed by STEMCELL Technologies, VWR, Thermo Fisher Scientific, Sigma Aldrich and a number of international distribution companies.
Management believes that BioLife products are now embedded in an estimated 200 pre-clinical validation projects and human clinical trials for new cell and tissue-based regenerative medicine products and therapies. A significant number involve CAR-T cells and other types of T cells and mesenchymal stem cells targeting blood cancers, solid tumors and other leading causes of death and disability.
Mike Rice, BioLife Solutions CEO, remarked, "We had another solid quarter, with continued adoption of CryoStor and HypoThermosol in new cellular therapy clinical trials. Moreover, there is strong interest in our evo smart shipper and biologistex cloud hosted cold chain management app for time and temperature sensitive biologic payloads. We expect to begin deploying evo smart shippers to customer subscribers to our SaaS service in modest quantities and generating revenue from this new initiative in the third quarter of 2015."
Within the cellular immunotherapy segment of the regenerative medicine market, BioLife's products are embedded in the manufacturing, storage, and delivery processes of at least 80 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders. A large majority of private and publicly-traded cellular immunotherapy companies are BioLife customers.
About BioLife's Addressable Markets
The Roots Analysis market research report titled Dendritic Cell and CAR-T Therapies, 2014 – 2024, published last November, estimates that the cellular immunotherapies market could grow to $4 billion by 2024. BioLife's addressable share of this market is attributed to the demand for biopreservation media and controlled temperature shipping containers.
The Global Healthcare Cold Chain Logistics Market Report & Forecast published by the IMARC Group forecasts that the demand for cold chain packaging and instrumentation services will grow from $3.2 billion in 2013 to $5.1 billion in 2018. BioLife management believes its addressable market for small payload shippers and related monitoring devices is several hundred million dollars.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. This enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements concerning the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, projected financial results, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; reliance upon SAVSU for completing the development and manufacturing of biologistex CCM's products; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com
SOURCE BioLife Solutions, Inc.
We believe the promise of cell and gene therapies starts with the integrity of a single cell
Advancing the future of cell and gene therapy
The human body can heal itself. Cell and gene therapies are designed to augment the patient’s ability to fight disease but only if the living cells behind those therapies remain viable and functional throughout the production processes. At BioLife Solutions, our mission is to protect the integrity of cells and provide trusted tools, services, and expertise that can enable our customers to advance the development and delivery of cell and gene therapies. We believe the future of cell and gene therapies hinges on the integrity of every single cell and we are here to protect that promise.
We understand the technical demands of bioprocessing in this field, and our advanced biopreservation expertise, cell culture optimization products, innovative storage systems, and closed-system manufacturing solutions are designed to enhance process efficiency, maintain cellular viability, and ensure reproducibility at every stage. Whether scaling up from R&D, navigating clinical trials or optimizing cryopreservation protocols for commercial production, we provide the tools and experience to streamline your workflow and safeguard your therapies.
Streamline workflows and safeguard therapies
GMP-COMPATIBLE
Precision
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GMP-COMPATIBLE
Our biopreservation media and storage solutions are engineered to maintain cell integrity and functionality. With GMP-compatible, validated formulations, we help you reduce variability and improve post-thaw recovery, ensuring robust and reproducible outcomes.
CELL VIABILITY
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CELL VIABILITY
With deep industry experience, regulatory support, and a commitment to innovation, BioLife Solutions is dedicated to supporting bioprocess engineers in overcoming complex manufacturing challenges. Whether optimizing cryopreservation protocols or ensuring the seamless transition from lab to clinic, we are dedicated to your success.
QUALITY & COMPLIANCE
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QUALITY & COMPLIANCE
Enhance efficiency and consistency in your cell processing workflow with our closed-system tools for fluid management and cell processing that are automation ready. Reduce manual handling errors, improve throughput, and achieve higher standards of quality and compliance as you scale towards commercialization.
REGULATORY SUPPORT
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REGULATORY SUPPORT
BioLife Solutions delivers specialized tools and expertise to help bioprocess engineers streamline and strengthen biopreservation processes across the cell therapy workflow. From selecting the right biopreservation media to minimizing cell loss during freezing, storage, and transports, our solutions are designed to improve consistency, reduce risk, and support a successful transition from development to clinical application.
Work with experts who understand your biopreservation challenges
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Collaborative and comprehensive CDMO support
At BioLife Solutions, we partner with leading contract development and manufacturing organizations (CDMOs) to enhance their biopreservation and cell processing capabilities. By providing advanced tools, regulatory support, and process optimization strategies, we empower CDMOs to better serve therapy developers, ensuring quality, consistency, and scalability in cell therapy manufacturing.
Regulatory
readiness
Navigating the complex regulatory landscape of cell and gene therapy requires a proactive approach. BioLife Solutions offers experienced regulatory support to help prepare your biopreservation and cell processing methods to meet global standards. From IND and BLA submissions to compliance with GMP, FDA, and EMA guidelines, our solutions help streamline approval pathways.
STORE
CellSeal®
CryoCase
Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates
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Stay ahead with our comprehensive Evidence Library, a curated collection of scientific publications, white papers, and case studies demonstrating the efficacy of BioLife Solutions’ technologies. Access peer-reviewed research, real-world application data, and expert insights to support your bioprocessing and regulatory strategies.
