8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 14, 2019

BIOLIFE SOLUTIONS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-36362	94-3076866
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3303 Monte Villa Parkway,

Bothell, WA 98021

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (425) 402-1400

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On March 14, 2019, BioLife Solutions, Inc. (the “Company”) issued a press release announcing the financial results and operational highlights for the fourth quarter and full year ended December 31, 2018. A copy of the press release is furnished as Exhibit 99.1 to this current report on Form 8-K.

Item 8.01 Other Events.

On March 14, 2019, the Company issued a press release announcing that the Company entered into an agreement to acquire Astero Bio Corporation, a privately-held company in the design, development and commercialization of novel automated thawing devices. A copy of the press release is furnished as Exhibit 99.2 to this current report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release, dated March 14, 2019 (Financial Results and Operational Highlights)
99.2	Press release, dated March 14, 2019 (Announcement of Acquisition)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Biolife Solutions, Inc.
Date: March 14, 2019	By:	/s/ Roderick de Greef
		Name: Roderick de Greef Title: Chief Financial Officer

EX-99.1

Exhibit 99.1

 

BioLife Solutions Announces Fourth Quarter and Full Year 2018 Financial Results

Revenue Increased 79% for the Year to $19.7 Million

Net Income of $2.9 Million

Gained 84 New Direct Cell & Gene Therapy Customers

Conference Call and Webcast Begin at 4:30 p.m. Eastern Time Today

BOTHELL, Washington — March 14, 2019 —BioLife Solutions, Inc. (NASDAQ: BLFS) (“BioLife”), the leading developer, manufacturer and marketer of proprietary cell and tissue hypothermic storage and cryopreservation freeze media, today reported financial results and operational highlights for the fourth quarter and full year ended December 31, 2018.

Revenue from biopreservation media product sales for the fourth quarter of 2018 reached a new record of $5.5 million, an increase of 74% compared with the fourth quarter of 2017. Revenue for the full year 2018 was $19.7 million, an increase of 79% over 2017. Revenue growth was primarily driven by sales of CryoStor^® biopreservation media products to the high-growth regenerative medicine segment and BioLife’s worldwide distributor network.

Mike Rice, BioLife President & CEO, commented, “2018 was a banner year for BioLife on several fronts, with record revenue of nearly $20 million, our first full year of profitability, the addition of 84 new direct cell and gene therapy customers, and 57 new FDA master file cross references for the use of CryoStor and HypoThermosol in customer clinical trials. We expect to deliver another strong performance in 2019, driven by demand for our biopreservation media products and our newly acquired Astero automated thawing technologies.”

2018 Market Segment & Channel Highlights

Regenerative Medicine (cell therapy, tissue engineering, stem cell transplant)

● Product revenue: $11.0 million; 56% of total revenue representing a 108% increase over 2017.

● Shipped first-time orders to 84 new direct cell or gene therapy customers.

● Processed 57 FDA master file cross reference letters supporting our products in planned cell or gene therapy clinical trials. This is up from 27 in 2016 and 47 in 2017.

Distributors

● Product revenue: $6.4 million; 33% of total revenue with 99% growth over 2017.

● Key worldwide distributors: STEMCELL Technologies, MilliporeSigma, Thermo Fisher and VWR.

● Provided scientific and technical support to an increasing number of distributor customers in the cell and gene therapy market segment, specifically in China.

Financial Highlights for the Fourth Quarter and Full Year 2018

REVENUE

● Total revenue for the fourth quarter of 2018 increased to $5.5 million compared with $3.1 million for the fourth quarter of 2018, a year-over-year gain of 74%.

● Total revenue for the year 2018 increased to $19.7 million compared with $11.0 million for the year 2017, a year-over-year gain of 79%.

GROSS MARGIN

● Gross margin for the fourth quarter of 2018 was 69% compared with 59% in the fourth quarter of 2017.

● Gross margin for the year 2018 was 69% compared with 61% for the year 2017.

OPERATING INCOME/LOSS

● Operating income for the fourth quarter of 2018 was $1.0 million, compared with an operating loss of $218,000 for the fourth quarter of 2017.

● Operating income for the year 2018 was $3.7 million, compared with an operating loss of $1.1 million for the year 2017.

NET INCOME/LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

● Net income attributable to common stockholders for the fourth quarter of 2018 was $833,000, compared with a net loss of $664,000 for the fourth quarter of 2017.

● Net income attributable to common stockholders for the year 2018 was $2.9 million, compared with a net loss of $2.7 million for the year 2017.

EARNINGS/LOSS PER SHARE

● Earnings per share for the fourth quarter of 2018 were $0.04 on a fully diluted basis compared with a loss per share of ($0.05) per share for the fourth quarter of 2017.

● Earnings per share for the year 2018 were $0.14 on a fully diluted basis compared with a loss per share of ($0.21) for the year 2017.

EBITDA

● EBITDA, a non-GAAP financial measure, for the fourth quarter of 2018 was $828,000 compared with a negative $478,000 for the fourth quarter of 2017. Adjusted EBITDA for the fourth quarter of 2018 was $1.5 million compared with $132,000 for the fourth quarter of 2017.

● EBITDA for the year 2018 was $3.3 million compared with a negative $1.8 million for 2017. Adjusted EBITDA for the year 2018 was $5.5 million compared with $444,000 for the year 2017.

CASH

● Our cash and cash equivalents at December 31, 2018 were $30.7 million compared with $6.7 million at December 31, 2017. We believe our current cash resources, combined with continued expected cash flow from operations is more than adequate to fund the upfront and contingent payments related to the acquisition of Astero.

2019 Financial Guidance

Our financial guidance for the full year 2019 is based on expectations for our existing business and includes the expected impact of the acquisition of Astero beginning in the second quarter of 2019.

● Total revenue is expected to be in the range of $27 million to $30 million, reflecting overall year-over-year revenue growth of 37% to 52%.

● Gross margin is expected in the range of 69% to 70%.

● Operating expenses is expected in the range of $15.5 million to $16.5 million.

● Expectation for full-year operating profit, net income and EBITDA.

Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. EST this afternoon. To access the webcast, log on to the Investor Relations page of the BioLife Solutions website at 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: 7090558. 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 Solutions

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary biopreservation media for cells and tissues. Our HypoThermosol^® hypothermic storage and CryoStor^® cryopreservation freeze media are highly valued in the regenerative medicine, biobanking and drug discovery markets. These novel biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function. For more information, please visit www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are 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, commercial manufacturing of our customers' products, projected financial results, cash flow and liquidity, including the continuing to achieve GAAP operating profit, net income and EBITDA for the full-year of 2019, the timing and terms for closing of the company's acquisition of Astero, the expected financial performance of the company following the completion of the acquisition, the expected synergies between the company and Astero following closing of the acquisition, the company’s ability to realize all or any of the anticipated benefits associated with the acquisition, the company’s ability to implement its business strategy and anticipated business and operations following the acquisition of Astero. 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 our products or Astero’s products; uncertainty regarding third party market projections; market volatility; competition; litigation; the satisfaction or waiver of all closing conditions to the acquisition of Astero; the risk that the acquisition may not be completed on the terms or in the time frame expected by the company; unexpected costs, charges or expenses resulting from the acquisition of Astero; the ability of the company to implement its business strategy 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.

Discussion of Non-GAAP Financial Measures

BioLife’s management believes that the non-GAAP measure of “EBITDA” and “Adjusted EBITDA” enhances an investor’s understanding of the Company’s financial and operating performance and its future prospects by being more reflective of core operating performance. BioLife’s management uses this financial metric for strategic decision making, forecasting future financial results, and evaluating current period financial and operating performance. The presentation of non-GAAP financial information is not intended to be reviewed in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. A reconciliation of GAAP to non-GAAP results is included in the financial tables in this press release.

EBITDA Definition:

“EBITDA” is a non-GAAP measure defined by BioLife as net income/(loss) excluding interest expense/(income), income tax expense, depreciation expense, and amortization expense.

Adjusted EBITDA Definition:

“Adjusted EBITDA” is a non-GAAP measure defined by BioLife as net income/(loss) excluding interest expense/(income), income tax expense, depreciation expense, amortization expense, stock-based compensation expense, and the loss/(gain) on equity method investments.

# # # #

Media & Investor Relations

Roderick de Greef

Chief Financial Officer

(425) 686-6002

rdegreef@biolifesolutions.com

BIoLife Solutions, Inc.

Unaudited Condensed Statements of Operations

(In thousands, except per share amounts)

	Three Months Ended						Year Ended
	December 31, 2018			December 31, 2017			December 31, 2018			December 31, 2017
Revenue	$	5,456		$	3,134		$	19,742		$	11,022
Cost of product sales		1,710			1,294			6,217			4,276
Gross profit		3,746			1,840			13,525			6,746
Gross margin %		69	%		59	%		69	%		61	%
Operating expenses
Research and development		315			295			1,298			1,193
Sales and marketing		637			539			2,615			2,086
General and administrative		1,751			1,224			5,950			4,523
Total operating expenses		2,703			2,058			9,863			7,802
Operating income/(loss)		1,043			(218	)		3,662			(1,056	)
Loss from equity method investment in SAVSU		(309	)		(298	)		(672	)		(1,005	)
Other income (expenses)		159			(42	)		276			(454	)
Total other income (expenses)		(150	)		(340	)		(396	)		(1,459	)
Net income/(loss) before income taxes		893			(558	)		3,266			(2,515	)
Income taxes	––			––			––			––
Net income/(loss)		893			(558	)		3,266			(2,515	)
Less: Preferred stock dividends and accumulated deficit impact of preferred stock redemption		(60	)		(106	)		(339	)		(213	)
Net income/(loss) attributable to common stockholders	$	833		$	(664	)	$	2,927		$	(2,728	)
Basic net income/(loss) per common share	$	0.05		$	(0.05	)	$	0.18		$	(0.21	)
Diluted net income/(loss) per common share	$	0.04		$	(0.05	)	$	0.14		$	(0.21	)
Basic weighted average common shares outstanding		18,415			13,744			16,256			13,264
Diluted weighted average common shares outstanding		23,725			13,744			21,627			13,264

Non-GAAP Reconciliation:

	Three Months Ended						Year Ended
	December 31, 2018			December 31, 2017			December 31, 2018			December 31, 2017
Net income/(loss)	$	893		$	(558	)	$	3,266		$	(2,515	)
Interest expense/(income), net		(159	)		1			(276	)		190
Depreciation expense		94			79			338			338
Amortization of debt discount	––			––			––				156
EBITDA		828			(478	)		3,328			(1,831	)
Share-based compensation (non-cash)		388			312			1,519			1,270
Loss from equity-method investment in SAVSU (non-cash)		309			298			672			1,005
Adjusted EBITDA	$	1,525		$	132		$	5,519		$	444

BIoLife Solutions, Inc.

Unaudited Condensed Balance Sheet Information

(In thousands)

	December 31, 2018		December 31, 2017
Cash and cash equivalents	$	30,657	$	6,663
Accounts receivable		3,045		1,021
Inventories		3,509		1,847
Total current assets		37,564		9,931
Total assets		45,467		12,143
Total current liabilities		1,939		1,513
Total liabilities		2,319		2,051
Total Shareholders' equity		43,148		10,092

BIoLife Solutions, Inc.

Unaudited Condensed Statement of Cash Flows Information

(In thousands)

	Year Ended
	December 31, 2018			December 31, 2017
Cash provided/(used) by operating activities	$	2,348		$	605
Cash provided/(used) by investing activities		(6,500	)		(144	)
Cash provided/(used) by financing activities		28,146			4,796
Net increase (decrease) in cash and equivalents	$	23,994		$	5,257

EX-99.2

Exhibit 99.2

BioLife Solutions Expands Cell and Gene Therapy Tools Portfolio

with Acquisition of Astero Bio

Gains products that automate the thawing process for high-value biologic therapies

Provides access to addressable market projected to exceed $150 million by 2024

Conference call and webcast begin at 4:30 p.m. Eastern time today

BOTHELL, Wash. March 14, 2019 – BioLife Solutions, Inc. (NASDAQ: BLFS) (“BioLife”) today announced that it has entered into an agreement to acquire Astero Bio Corporation (“Astero”), a privately-held innovator in the design, development and commercialization of novel automated thawing devices, for an upfront cash payment of $8.0 million.

This transaction is expected to further strengthen BioLife’s position as a leading supplier of disruptive, enabling solutions used in the manufacture, storage and distribution of cell and gene therapies. We believe Astero’s ThawSTAR^® product line broadens BioLife’s bioproduction tools portfolio and increases the Company’s footprint and engagement level in its customers’ cell and gene therapy manufacturing workflow.

Under the terms of the share purchase agreement, Astero shareholders are eligible to receive up to an additional $4.5 million in cash based on the completion of certain product development milestones and an additional $8.0 million in cash over the next three years based on attainment of specific revenue targets. The transaction includes all Astero intellectual property comprised of 20 pending patents related to thawing and other cold chain technologies. The transaction is expected to close within 30 days.

Mike Rice, BioLife CEO, commented, “The addition of Astero’s products supports our mission of building a broader cell and gene therapy tools company that we believe will offer more value to our customers in the high-growth regenerative medicine market. Reimbursement of cell and gene therapies is evolving into a “pay on cure” paradigm, with payment predicated on a positive patient response. Like our biopreservation media products, Astero products mitigate the risk of administering a non-viable dose. The synergies in this transaction include targeting the same customer base.”

Astero CEO and co-founder Samuel Kent, a seasoned life science tools sales and marketing executive, will join BioLife upon closing as Vice President, Thaw Technology Sales. “We are thrilled to join the BioLife team,” said Kent. “We’ve known the Company and its leadership for many years and have admired their thoughtful strategy and crisp execution. As a result, CryoStor^® and HypoThermosol^® are the de facto standard for cell and gene therapy biopreservation media. No doubt the ThawSTAR^® product line will benefit from leveraging Biolife’s sales and marketing capabilities and the reputation of Aby J. Mathew, Ph.D., BioLife’s CTO, in the regenerative medicine scientific community.”

The ThawSTAR^® product line is comprised of a family of automated thawing devices for frozen cell and gene therapies packaged in cryovials and cryobags. The products improve the quality of administration of high-value, temperature-sensitive biologic therapies to patients by standardizing the thawing process and reducing the risks of contamination and overheating, which are inherent with the use of traditional water baths. In a recently published market research report, Infinium Global Research estimates that the worldwide market for automated thawing devices will exceed $150 million by 2024, driven by the growth in the number of cell and gene therapy clinical trials and approvals.

Expected Strategic Benefits of the Transaction

● Sales and Marketing Leverage: BioLife expects to leverage existing relationships with key decision makers among its marquee customer base that includes leading cell and gene therapy companies in the regenerative medicine market. The ThawSTAR^® technologies are considered best practices in the bioproduction of cell and gene therapies and expected to resonate with the regenerative medicine industry.

● Reimbursement Leverage: The reimbursement environment for expensive regenerative therapies is evolving into a “pay on cure” paradigm. With reimbursement predicated on therapeutic efficacy and patient response, cell and gene therapy companies need to mitigate the risk associated with administering a non-viable dose to the patient. Key risk mitigators include using optimized preservation media and automated thawing devices.

Financial Impact

“While we expect the revenue contribution in 2019 from the Astero product line to be relatively modest, we believe that by 2021, this could contribute as much as 15% of BioLife’s total revenue. Furthermore, we believe the transaction will be accretive on an adjusted EBITDA basis within 12 to 18 months,” stated Roderick de Greef, Chief Financial Officer. “We expect the transaction to close within 30 days, and will provide additional commentary on the financial impact of the acquisition when we review our 2019 guidance on this afternoon’s conference call.”

Conference Call & Webcast

The Company will host a conference call and live webcast beginning at 4:30 p.m. Eastern time this afternoon to discuss 2018 fourth quarter and full year financial results, discuss the transaction and provide other business updates. To access the live webcast, please go to www.biolifesolutions.com and click on the top banner, or directly at 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: 7090558.  A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.

About Astero Bio

Astero Bio Corporation is a leader in novel tools and technologies for life science research, pharmaceutical manufacturing and clinical applications. Astero specializes in the development and commercialization of next-generation tools to aid in multiple stages of the lifecycles of biologics. Astero’s ThawSTAR^® Automated Cell Thawing Systems are designed to replace uncontrolled and highly variable manual methods, de-risking the therapeutic cell thawing process and optimizing cell efficacy. An industry first, ThawSTAR systems optimize cell thawing using a customizable algorithm for each unique cell therapy product and protocol. These systems, combined with Astero’s ultra-low temperature cold storage and transport solutions, advance the physical management of biologics by providing safe, controlled and scalable processing of temperature-sensitive samples and products. For more information, please visit www.asterobio.com.

About BioLife Solutions

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. Our proprietary HypoThermosol^® and CryoStor^® platform of solutions are highly valued in the regenerative medicine, biobanking and drug discovery markets. Our biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function.

For more information, please visit www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the timing and terms for closing of the company's acquisition of Astero, the expected financial performance of the company following the completion of the acquisition, the expected synergies between the company and Astero following closing of the acquisition, the company’s ability to realize all or any of the anticipated benefits associated with the acquisition, the company’s ability to implement its business strategy and anticipated business and operations following the acquisition of Astero, the potential utility of and market for its products and services, potential revenue growth and market expansion (including following the acquisition of Astero), regulatory approvals and/or commercial manufacturing of our customers' products, and potential customer revenue. 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 the satisfaction or waiver of all closing conditions to the acquisition of Astero; the risk that the acquisition may not be completed on the terms or in the time frame expected by the company; unexpected costs, charges or expenses resulting from the acquisition of Astero; market adoption of the company’s products or Astero’s products; the ability of the transaction to be accretive on an adjusted EBIDTA basis within a 12 – 18 month timeframe, the ability of the company to implement its business strategy; 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

Roderick de Greef

Chief Financial Officer

(425) 686-6002

rdegreef@biolifesolutions.com