On March 11, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported financial results and operational highlights for the fourth quarter and full year ended December 31, 2019 (Press release, BioLife Solutions, MAR 11, 2020, View Source [SID1234555434]).

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Mike Rice, BioLife CEO, commented, "2019 saw a remarkable transition for BioLife, as we transformed the business from a single product company to a multi-solution provider of class-defining bioproduction tools to the cell and gene therapy industry.

We posted record revenue of $27.4 million and record adjusted EBITDA of $5.7 million, driven by our 2019 acquisitions, which we believe confirms that our strategy to innovate and consolidate in this highly-fragmented industry is bearing fruit. In 2019, we gained nearly 200 new customers and confirmed our biopreservation media products were spec’d into 69 additional clinical trials. Our customer base includes most of the leading and late stage cell and gene therapy companies and with our 2019 acquisitions, we are currently serving a majority of the companies in the space with at least one product in our bioproduction tools portfolio. In addition to our products being embedded in the commercial shipments of YESCARTA and ZOLGENSMA, at least one of our portfolio products is spec’d into seven additional cell or gene therapies that could gain approval in 2020.

We believe that we have a tremendous opportunity to expand our product offering and grow revenue organically and from additional acquisitions of other innovative tools providers."

2019 M&A Recap

April: Astero Bio; automated, water-free thawing products for biologic source material and manufactured cell and gene therapy products
August: SAVSU Technologies; class-defining cloud-connected, evo shipping containers and a SaaS for cold chain management of biologic source material and manufactured cell and gene therapy products
November: Custom Biogenic Systems (CBS); high capacity controlled rate freezers, liquid nitrogen storage tanks and related accessories
Revenue Highlights for the Fourth Quarter and Full Year 2019

Total revenue for the fourth quarter of 2019 increased to $8.3 million compared with $5.5 million for the fourth quarter of 2018, a year-over-year gain of 52%.
Total revenue for the year 2019 increased to $27.4 million compared with $19.7 million for the year 2018, a year-over-year gain of 39%.
Biopreservation media revenue was $5.2 million for the fourth quarter of 2019, a decrease of 5% compared with the fourth quarter of 2018. Two customers ordered $1 million less than their Q4 forecasts; the first was a direct cell therapy customer whose production demand was lower, so they consumed existing media inventory. The other was a large distributor. Despite this shortfall, revenue from this distributor was up 76% vs. 2018, and they shipped our media products to more than 1,700 customers in 2019. For the full year 2019, media revenue was $23.4 million, an increase of 18% over 2018. Two direct clinical stage customers were down $2.5 million vs. 2018. Excluding these two customers, our remaining biopreservation media customer revenue grew 44% over 2018.
Automated thaw revenue was $480,000 and $1.2 million for the fourth quarter and full year of 2019, respectively. Over 300 units of the ThawSTAR vial products have been shipped since the acquisition in April 2019.
evo revenue was $481,000 and $692,000 for the fourth quarter and full year of 2019, based on 4.5 months of BioLife’s ownership. For 2019, over 1,000 worldwide shipments were made and tracked utilizing the evo liquid nitrogen dewar and evo SaaS application.
Freezer revenue resulting from the November acquisition of CBS, totaled $2.1 million for the fourth quarter.
Additional Financial Highlights for the Fourth Quarter and Full Year 2019

GROSS MARGIN

Gross margin (GAAP) for the fourth quarter of 2019 was 62% compared with 69% in the fourth quarter of 2018. Adjusted gross margin (non-GAAP) for the fourth quarter was 65%.
Gross margin (GAAP) for the year 2019 was 68% compared with 69% for the year 2018. Adjusted gross margin (non-GAAP) for the year 2019 was 69%.
OPERATING EXPENSES

Operating expenses (GAAP) for the fourth quarter of 2019 were $6.3 million compared with operating expenses of $2.7 million for the fourth quarter of 2018. Adjusted operating expenses (non-GAAP) were $5.5 million for the fourth quarter of 2019.
Operating expenses (GAAP) for the year 2019 were $18.8 million compared with operating expenses of $9.9 million for the year 2018. Adjusted operating expenses (non-GAAP) were $17.1 million for 2019.
OPERATING INCOME/(LOSS)

Operating loss (GAAP) for the fourth quarter of 2019 was $1.2 million compared with operating income of $1.0 million for the fourth quarter of 2018. Adjusted operating loss (non-GAAP) was $163,000 for the fourth quarter.
Operating loss (GAAP) for the year 2019 was $336,000 compared with operating income of $3.7 million for the year 2018. Adjusted operating income (non-GAAP) for the year 2019 was $1.8 million.
NET INCOME/LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

Net income attributable to common stockholders (GAAP) for the fourth quarter of 2019 was $481,000 compared with net income of $833,000 for the fourth quarter of 2018. Adjusted net loss (non-GAAP) was $74,000 for the fourth quarter of 2019 compared with $1.1 million in the fourth quarter of 2018.
Net income attributable to common stockholders (GAAP) for the year 2019 was $11.1 million, compared with a net income of $2.9 million for the year 2018. Adjusted net income (non-GAAP) for the year 2019 was $2.3 million compared with $3.6 million.
EARNINGS/(LOSS) PER SHARE

Earnings per share (GAAP) for the fourth quarter of 2019 were $0.02 on a fully diluted basis compared to earnings of $0.03 on a fully diluted basis for the fourth quarter of 2018. Adjusted EPS (non-GAAP) was zero on a fully diluted basis for the fourth quarter of 2019 compared with $0.04 in the fourth quarter of 2018.
Earnings per share (GAAP) for the year 2019 were $0.42 on a fully diluted basis compared to earnings of $0.12 on a fully diluted basis for the year 2018. Adjusted EPS (non-GAAP) was $0.08 on a fully diluted basis for 2019 compared with $0.15 in 2018.
EBITDA

EBITDA, a non-GAAP financial measure, for the fourth quarter of 2019 was negative $191,000 compared with positive $768,000 for the fourth quarter of 2018. Adjusted EBITDA (non-GAAP) for the fourth quarter of 2019 was $1.4 million compared with $1.5 million for the fourth quarter of 2018.
EBITDA, a non-GAAP financial measure, for the year 2019 was $10.8 million compared with $3.0 million for the year 2018. Adjusted EBITDA (non-GAAP) for the year 2019 was $5.7 million compared to $5.5 million in 2018.
2020 Financial Guidance

Our financial guidance for the full year 2020 is based on expectations for our existing business, and does not include any additional M&A activity, or any potential impact of COVID-19.

Revenue for 2020 is expected to be in the range of $48 million to $53 million, reflecting year-over-year revenue growth of 75% to 94%. Media revenue is expected to grow between 20% to 30% over 2019, and account for approximately 55% of total revenue. Freezer sales are expected to account for approximately 35% of total revenue, with automated thaw and evo product lines each accounting for approximately 5% of total revenue. We expect revenue in the first half of the year to represent 40% of the years total, with the remaining 60% realized in the second half of the year.
Gross margin for 2020 is expected to be in the range of 58% to 62%.
Operating expenses for 2020 are expected to be in the range of $28 to $30 million, which includes $2.8 million of intangible asset amortization expense.
We expect positive 2020 operating profit, net income and EBITDA, on a GAAP and non-GAAP basis. We expect to exit 2020 with an adjusted EBITDA (non-GAAP) margin of 20% to 25%.
Potential Impact of COVID-19 Coronavirus

The Seattle area, including the location of our corporate headquarters and our media production facility and warehouse, is currently the epicenter of the coronavirus outbreak in the US. We are following the recommendations of local health authorities to minimize exposure risk for our team members and visitors. We believe we have sufficient inventory to meet previously forecasted biopreservation media demand for the next six to nine months, and we are implementing various business continuity plans to reduce the potential impact of COVID-19. However, this is a dynamic situation, with an unknowable magnitude and duration. Our focus is on the health of our team members in all locations, and our ability to meet customer demand for our products.

Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. Eastern time today. To access the live webcast, please go to www.biolifesolutions.com/earnings/. 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: 9098230. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.