The following is from a release by BioLife Solutions:
Bothell-based BioLife Solutions, Inc. has reported operational highlights and financial results for the fourth quarter and full year of 2016.
The company is a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media.
Revenue from biopreservation media product sales reached a new high of $2.3 million in the fourth quarter of 2016, an increase of 24 percent over the same period in 2015. For the full year of 2016, revenue totaled a record $8.2 million, a 28 percent increase compared to $6.4 million in 2015. Revenue growth for both periods was driven by increased sales of CryoStor and HypoThermosol clinical grade biopreservation media products to the regenerative medicine segment, including increased order volume from later stage clinical customers that are developing CAR T-cell and other cellular immunotherapies for cancer and other leading causes of death.
“We are completely focused on executing our strategy to achieve our goal of positive quarterly EBITDAS by the end of the year,” said BioLife President and CEO Mike Rice. “We expect that a combination of continued revenue growth from the regenerative medicine market segment and lower operating expenses will enable BioLife to reach this milestone. 2017 could be a pivotal year for BioLife, with anticipated customer approvals of their cell therapies, and further adoption of CryoStor and HypoThermosol by new entrants in the high growth regenerative medicine market.”
2016 Operational Highlights
· 123 new customers were gained in 2016, including 65 in the high growth regenerative medicine market segment.
· Long term supply agreements were signed with Kite Pharma, Bellicum Pharmaceuticals, and TissueGene, illustrating our critical supplier role with these late stage clinical customers.
· Management estimates CryoStor and HypoThermosol are now incorporated in 250 regenerative medicine applications.
· Completed the restructuring of the biologistex JV with SAVSU, significantly reducing future cash outflows while maintaining a strong financial interest in the success of this disruptive cold chain management technology platform.
Q4 and 2016 Financial Results
· Gross margin was 61 percent for the fourth quarter and 58 percent for the full year of 2016.
· Total consolidated operating expenses for the fourth quarter were $2.0 million compared to $2.4 million in the third quarter of 2016. For the full year of 2016, consolidated operating expenses totaled $9.6 million compared to $8.8 million in 2015.
· Consolidated operating loss for the fourth quarter was $0.6 million compared to $1.1 million in the third quarter of 2016, and $1.4 million in the fourth quarter of 2015. Consolidated operating loss for the full year of 2016 was $4.9 million compared to $5.0 million in 2015.
· Net loss attributable to BioLife was $3.3 million for the fourth quarter of 2016, and included a one-time, non-cash loss on deconsolidation charge of $2.8 million related to the company’s restructuring of its biologistex joint venture. Excluding this charge, the net loss attributable to BioLife for the fourth quarter was $0.5 million compared to $1.1 million in the fourth quarter of 2015. Net loss attributable to BioLife for 2016 was $6.9 compared to $4.2 million in 2015. Excluding the one-time, non-cash loss on deconsolidation, net loss for 2016 was $4.1 million vs. $4.2 million in 2015.
· A number of cell therapy customers, including Kite Pharma, Kiadis Pharma and Kolon Life Sciences, are seeking regulatory approvals to commence marketing and commercial manufacturing in 2017, which, as a result, should drive increased demand for our proprietary biopreservation media products.
· Continued adoption of CryoStor and HypoThermosol in pre-IND validations and phase 1, 2 and 3 clinical trials of new cell and tissue based products and therapies.
· Adoption of the evo Smart Shipper and use of the biologistex Cold Chain Management SaaS by leading cell therapy companies.
Management reaffirms the full-year 2017 guidance provided in January as follows:
· Biopreservation media revenue is expected to grow between 20-25 percent over 2016, with revenue in excess of $10 million.
· Gross Margin is expected in a range of 55-60 percent.
· Annual operating expenses are expected to range from $8 to $9 million.
· Positive quarterly EBITDAS by the end of 2017.