Delaware | 0-18710 | 94-3076866 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File No.) | (IRS Employer Identification No.) |
Exhibit No.
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Description
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Press release dated February 25, 2016
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BIOLIFE SOLUTIONS, INC. | |||
Date: February 25, 2016
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By:
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/s/ Daphne Taylor | |
Daphne Taylor | |||
Chief Financial Officer | |||
Exhibit No.
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Description
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Press release dated February 25, 2016
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Biopreservation media product revenue reached a record high of $1.8 million in the fourth quarter of 2015, an increase of 25% over the same period in 2014. Fourth quarter revenue growth was primarily driven by increased sales of our CryoStor® and HypoThermosol® biopreservation media to the regenerative medicine segment, including initials order from several new customers that are developing cellular immunotherapies.
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Gross margin in the fourth quarter of 2015 increased to 63%, compared to 60% in the third quarter of 2015 and 60% in the prior year period. The improvement over 2014 reflects higher sales of biopreservation media products.
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Biopreservation media revenue increased 29% over 2014. This growth was driven by a 45% increase in revenue from the regenerative medicine segment. Also, product sales to distributors increased 20% over 2014.
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We gained 140 new customers, more than half of which are in the regenerative medicine segment.
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Gross margin was 59% for the full year 2015 compared to 49% in the prior year.
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Consolidated net loss was $5.0 million and net loss attributable to BioLife was $4.2 million compared to a net loss of $3.2 million in 2014. The increase in net loss is primarily the result of increased headcount and spending related to development and launch activities of our biologistex™ joint venture.
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We ended the year with $3.8 million in cash.
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Customer clinical validation projects and clinical trials of cell based therapies: At the end of 2015, we estimate this key metric increased to over 200, with as many as 25 phase 3 trials and more than 80 phase 2 trials underway.
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We believe that a majority of the private and public cellular immunotherapy companies developing various T cell therapies are using our products, as supported by direct product sales, visibility into distributor order flow, and requests to cross reference our FDA master files.
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biologistex® – We launched our biologistex cold chain management service, which includes access to our biologistex web app and use of the evo Smart Shipper.
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Cell Thawing Media - We launched two GMP low molecular weight dextran solutions for use in transitioning frozen cells intended for clinical administration to patients. We gained over 50 new customers for these products in 2015.
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BloodStor® 27 NaCl Freeze Media – We launched this new GMP cryopreservation media product to support customer applications including freezing therapeutic platelets for clinical use. The first substantial order was shipped to The Netherlands Ministry of Defense in the fourth quarter of 2015.
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New Australian patent granted, number 2009228056
and titled, “Materials and Methods for Hypothermic Collection of Whole Blood”.
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Two filed patent applications with claims related to novel features for next generations of the evo Smart Shipper and future releases of the biologistex ™ cloud based cold chain management app.
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Achievement in Medical Technology: Seattle Business Magazine.
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Medical Design Excellence Award (MDEA) for the evo Smart Shipper, designed and manufactured by SAVSU and marketed by BioLife. Category: Medical Product Packaging, Graphic Instructions, and Labeling Systems.
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100 best companies to work for in Washington State: Seattle Business Magazine.
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Revenue growth: We expect total revenue to exceed $10 million in 2016, with 20% to 30% growth in biopreservation media revenue over 2015 and including revenue from our biologistex™ cold chain logistics SaaS.
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Gross Margin: We expect gross margin to be in the range of 55% to 65% for the year.
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Operating Expenses: We anticipate a modest increase in operating expenses in 2016 as we continue to invest in sales and marketing efforts and to develop, test, and deploy new releases of our biologistex cold chain logistics app.
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Cash: We ended 2015 with $3.8 million in cash and anticipate that we will continue to use cash in 2016 and achieve cash flow breakeven by the end of 2016.
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In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030.
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Pharmaceutical Commerce estimates that in 2015, $10 billion was spent on cold chain logistics of pharmaceuticals, with $7 billion for transportation and $3 billion for specialized packaging and instrumentation. BioLife's addressable market is comprised of the demand for small payload shipping containers and related temperature monitoring and location tracking devices.
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Media & Investor Relations
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Daphne Taylor
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Senior Vice President, Chief Financial Officer
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(425) 402-1400
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dtaylor@biolifesolutions.com
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Three Months
Ended December 31,
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Year
Ended December 31,
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2015
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2014
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2015
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2014
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Product Sales
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$ | 1,819,503 | $ | 1,670,396 | $ | 6,448,910 | $ | 6,190,698 | ||||||||
Cost of product sales
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679,948 | 672,089 | 2,634,700 | 3,155,288 | ||||||||||||
Gross profit
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1,139,555 | 998,307 | 3,814,210 | 3,035,410 | ||||||||||||
Operating expenses
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Research and development
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425,781 | 357,707 | 1,378,807 | 871,100 | ||||||||||||
Sales and marketing
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763,953 | 519,467 | 2,583,731 | 1,329,746 | ||||||||||||
General and administrative
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1,354,123 | 1,125,396 | 4,868,801 | 3,970,254 | ||||||||||||
Total operating expenses
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2,543,857 | 2,002,570 | 8,831,339 | 6,171,100 | ||||||||||||
Operating loss
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(1,404,302 | ) | (1,004,263 | ) | (5,017,129 | (3,135,690 | ) | |||||||||
Other income (expenses)
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Gain on disposal of property and equipment
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–– | –– | –– | 4,400 | ||||||||||||
Interest income
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3,305 | 8,650 | 21,753 | 20,825 | ||||||||||||
Interest expense
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–– | –– | –– | (177,308 | ) | |||||||||||
Amortization of deferred financing costs
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–– | –– | –– | (13,022 | ) | |||||||||||
Total other income (expenses)
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3,305 | 8,650 | 21,753 | (165,105 | ) | |||||||||||
Net loss
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(1,400,997 | (995,613 | ) | (4,995,376 | (3,300,795 | ) | ||||||||||
Net loss attributable to non-controlling interest
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281,610 | 83,045 | 781,440 | 83,045 | ||||||||||||
Net Loss attributable to BioLife Solutions, Inc.
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$ | (1,119,387 | $ | (912,568 | ) | $ | (4,213,936 | $ | (3,217,750 | ) | ||||||
Basic and diluted net loss per common share attributable to BioLife Solutions, Inc.
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$ | (0.09 | ) | $ | (0.08 | ) | $ | (0.35 | ) | (0.31 | ) | |||||
Basic and diluted weighted average common shares used to calculate net loss per common share
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12,304,540 | 12,077,163 | 12,177,396 | 10,447,030 |
Selected Consolidated Balance Sheet Data
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December 31,
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December 31,
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2015
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2014
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Cash, cash equivalents and investments
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$ | 3,824,599 | $ | 9,938,394 | ||||
Accounts receivable
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929,289 | 901,623 | ||||||
Inventories
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1,834,635 | 965,224 | ||||||
Total current assets
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6,972,937 | 12,165,762 | ||||||
Total assets
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12,369,622 | 16,072,918 | ||||||
Total current liabilities
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1,725,793 | 1,261,776 | ||||||
Total liabilities
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2,510,251 | 2,136,601 | ||||||
Total BioLife Solutions, Inc. shareholders' equity
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8,508,471 | 11,803,977 |
Selected Consolidated Cash Flow Data
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Year Ended
December 31,
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2015
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2014
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Cash used in operating activities
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$ | (4,973,861 | ) | $ | (3,162,316 | ) | ||
Cash provided by (used in) investing activities
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4,239,608 | (8,135,023 | ) | |||||
Cash provided by financing activities
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368,753 | 13,679,824 | ||||||
Net increase (decrease) in cash and equivalents
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(365,500 | ) | 2,382,485 |
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