BioLife Solutions Reports 2nd Quarter 2015 Results
Conference Call and Webcast at 4:30PM EDT Today
PR Newswire
BOTHELL, Wash.

 

BOTHELL, Wash., Aug. 6, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today reported financial results and operational highlights for the second quarter of 2015.

Q2 2015 Financial Highlights

  • Proprietary products revenue was $1.4 million in the second quarter of 2015, an increase of 33% over the same period in 2014. Second quarter revenue growth was driven by increased sales of our CryoStor and HypoThermosol biopreservation media to the regenerative medicine segment. For the first six months of 2015, proprietary products revenue increased 32% as compared to last year.
  • Gross margin in the second quarter of 2015 was 55%, compared to 45% in the second quarter of 2014. The improvement over 2014 reflects higher sales off our proprietary biopreservation media products and reduced low margin contract manufacturing revenue as compared to the second quarter of 2014.
  • Consolidated net loss attributable to BioLife for the second quarter of 2015 was $1.0 million or $0.08/share, compared to a net loss of $0.9 million or $0.07/share in the second quarter of 2014. The increase in the loss is primarily the result of increased headcount and spending related to development and launch activities of our biologistex joint venture.
  • Cash used in operations during the second quarter was $1.2 million, resulting in a cash balance of $7 million at the end of the quarter.  

Mike Rice, BioLife's President & CEO, said, "The revenue growth in Q2 reflects our focus on executing our strategic plan to increase sales in the regenerative medicine market, which represents our most significant growth opportunity. Our CryoStor and HypoThermosol product lines experienced continued growth driven by increased adoption by clinical centers and companies conducting clinical studies of cellular immunotherapy candidates including CAR-T cells."

Rice continued, "We also made significant progress this quarter toward the commercial launch of our biologistex cloud-based cold chain management service, with a family of GPS and cellular enabled smart shippers and our simple to use but extremely powerful  subscription based logistics software. We are on track to begin deployment of the service during the third quarter. Our timing is well aligned with anticipated growth in the regenerative medicine market and we look forward to providing more value to our customers."

Operational Highlights

  • Adoption of the Company's biopreservation media products in approximately 200 pre-clinical validation projects and clinical studies of new cellular immunotherapies and cell and tissue based regenerative medicine products.
  • A large majority of the private and public cellular immunotherapy companies are BioLife customers. Several new public disclosures on the use of CryoStor and HypoThermosol were noted at the recent International Society for Cellular Therapy annual meeting, including customers GSK, HemaCare, MaSTherCell (for Imcyse) and Rooster Bio.
  • We estimate that each customer clinical cellular therapy cellular candidate, if approved and manufactured at scale, could contribute $500,000 to $2,000,000 in annual revenue from sales of our proprietary biopreservation media products.
  • We are in final validation of our evo™ smart shipper and biologistex™ cloud hosted cold chain management app and are executing to support full commercialization.
  • The evo smart shipping container was the silver award recipient at the recent Medical Design Excellence Awards competition for the category Medical Product Packaging, Graphic Instructions, and Labeling Systems.
  • Allowance of a new patent in Australia relating to effective bulk freezing of cell monolayers in multi-well plates for high throughput screening applications in drug discovery and toxicology.
  • CryoStor, our serum, protein, and animal origin free GMP freeze media for cells and tissues, was cited in a new clinical article for a dendritic cell based vaccine. The article, published in the journal Oncotarget, can be viewed here: Phase I/II clinical trial of dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy in patients with metastatic, castration-resistant prostate cancer.

2015 Expectations

Management has the following expectations for the second half of 2015:

  • Continued adoption and use of our proprietary biopreservation media products. We estimate 20% - 30% revenue growth for these products (excluding biologistex).
  • Full commercialization of our SaaS biologistex Cold Chain Management service with modest revenue from initial implementation of the service to customers in the third quarter of 2015.
  • Gross margin is expected to be in a range of 55% to 60%.
  • Increased sales and marketing expenses related to the rollout of the biologistex service.
  • Ending the year with approximately $4 million in cash. The use of cash in 2015 includes substantial costs related to the development and marketing launch of our biologistex Cold Chain Management service. We anticipate that our current cash is sufficient to meet our needs for the foreseeable future and do not expect a need to raise operating capital in 2015 or 2016.

Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. EDT this afternoon. To access the webcast, please log on to the Investor Relations page of the BioLife Solutions website at www.biolifesolutions.com. Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID:  98461636. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.

About BioLife's Addressable Markets

Global Regenerative Medicine Market

The Alliance for Regenerative Medicine (ARM) recently released its Q2 and first half 2015 Data Report on funding activity in this market segment.  Globally, companies in the combined regenerative medicine and advanced therapies field raised more than $4.9 billion in the second quarter of 2015 and $7.6 billion in the first half of 2015, up 129% and 137%, respectively, compared to the same time periods last year. The report also includes additional information by technology focus area and financing type.  In the European region this year, regenerative medicine and advanced therapies companies raised $1.5 billion in the first half of 2015, up 183% compared to the first half of 2014. The report is available here: http://alliancerm.org/page/arm-quarterly-report.

Biopreservation Media

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.

Cold Chain Management Solutions

Pharmaceutical Commerce estimates that in 2014, $8.4 billion was spent on cold chain logistics of pharmaceuticals, with $5.6 billion for transportation and $2.8 billion for specialized packaging and instrumentation. BioLife's addressable market is comprised of the demand for small payload shipping containers and related temperature monitoring and location tracking devices.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  BioLife's 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 new products, the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, and, projected financial results and liquidity. 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; 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

 

 

BioLife Solutions, Inc.

Consolidated Statement of Operations

(unaudited)

             
   

Three Months

Ended June 30,

   

Six Months

Ended June 30,

   

2015

 

2014

   

 

2015

   

 

2014

Product Sales

$

1,496,759

 

$

1,211,900

 

$

2,997,481

 

$

3,276,930

Cost of product sales

 

678,111

   

665,580

   

1,296,210

   

1,828,221

 

     Gross profit

 

818,648

   

545,320

   

1,701,271

   

1,448,709

                       

Operating expenses

                     
 

       Research and development

 

301,334

   

192,778

   

623,499

   

360,065

 

       Sales and marketing

 

642,490

   

270,616

   

1,142,745

   

512,016

 

       General and administrative

 

1,030,701

   

969,799

   

2,251,406

   

1,833,542

Total operating expenses

 

1,974,525

   

1,433,193

   

4,017,650

   

2,705,623

                         

Operating loss

 

(1,155,877)

   

(887,873)

   

(2,316,379)

   

(1,256,914)

                         
 

Other income (expenses)

                     
 

       Interest income

 

5,482

   

4,517

   

13,719

   

4,517

 

       Interest expense

 

––

   

––

   

––

   

(177,308)

 

       Amortization of deferred financing costs

 

––

   

––

   

––

   

(13,022)

 

Total other income (expenses)

 

5,482

   

4,517

   

13,719

   

(185,813)

                         
 

Net loss

 

(1,150,395)

   

(883,356)

   

(2,302,660)

   

(1,442,727)

 

Net loss attributable to non-controlling interest

 

156,016

   

––

   

276,799

   

––

 

Net Loss attributable to BioLife Solutions, Inc.

$

(994,379)

 

$

(883,356)

 

$

(2,025,861)

 

$

 

(1,442,727)

                         
 

Basic and diluted net loss per common share

$

(0.08)

 

$

(0.07)

 

$

(0.17)

 

$

 

(0.16)

                       

Basic and diluted weighted average common shares used to calculate net loss per common share

 

12,144,776

   

12,010,361

   

12,122,667

   

8,807,376

 

Selected Consolidated Balance Sheet Data

June 30,

 

December 31,

 

2015

 

2014

Cash, cash equivalents and investments

 

$

6,852,833

   

$

9,938,394

Accounts receivable

   

809,387

     

901,623

Inventories

   

1,321,257

     

965,224

Total current assets

   

9,296,889

     

12,165,762

Total assets

   

13,870,187

     

16,072,918

Total current liabilities

   

1,160,156

     

1,261,776

Total liabilities

   

1,993,132

     

2,136,601

Total BioLife Solutions, Inc. shareholders' equity

   

10,021,514

     

13,936,317

 

  Selected Consolidated Cash Flow Data

Six Months Ended

June 30, 

 

2015

 

2014

Cash used in operating activities

 

$

(2,534,961)

   

$

(1,767,644)

Cash provided by (used in) investing activities

   

3,812,639)

     

(6,163,223)

Cash provided by financing activities

   

79,969

     

13,676,822

Net increase in cash and equivalents

   

1,357,647

     

5,745,955

 

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.

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.

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STORE

CellSeal®
CryoCase

Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates

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Data-driven
decision making

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.

Insights

May 21, 2025

Designing the Ideal Cryostorage Container for CGT

April 18, 2025

The Cell Summit ’25: A Must-Attend Event for Innovators in Cell & Gene Therapy

March 27, 2025

Optimizing Biopreservation Strategies for Apheresis-Derived Cells in Immunotherapeutic Applications

February 19, 2025

How to prepare early for regulatory submissions from IND to BLA

Preserve, protect and expand cell performance

Mastering
Biopreservation

Ensure Regulatory Submission Readiness

Automate & Close
CGT Processes

Protect & Expand
Cell Performance