Loading...
Docoh

Biolife Solutions (BLFS)

Filed: 10 May 22, 4:02pm
 

 

Table of Contents



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 


 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                  to

 

 

Commission File Number 001-36362

 

 


BioLife Solutions, Inc.

(Exact name of registrant as specified in its charter)

 

pic1.jpg
 

 

Delaware

94-3076866

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

 

3303 Monte Villa Parkway, Suite 310, Bothell, Washington, 98021

(Address of registrants principal executive offices, Zip Code)

 

(425) 402-1400

(Telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading symbol

Name of exchange on which registered

BioLife Solutions, Inc. Common Shares

BLFS

NASDAQ Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (S232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit said files). Yes ☑  No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☑  Accelerated filer ☐  Non-accelerated filer ☐  Smaller reporting company ☐  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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐  No ☑

 

As of May 6, 2022, 42,409,719 shares of the registrant’s common stock were outstanding.

 

BIOLIFE SOLUTIONS, INC.

 

FORM 10-Q

 

FOR THE QUARTER ENDED MARCH 31, 2022

 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION3
   
Item 1.

Unaudited Condensed Consolidated Financial Statements

3
   
 Unaudited Condensed Consolidated Balance Sheets as of March 31, 2022 and December 31, 20213
   
 Unaudited Condensed Consolidated Statements of Operations for the three month periods ended March 31, 2022 and 20214
   
 Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three month periods ended March 31, 2022 and 20215
   
 Unaudited Condensed Consolidated Statements of Shareholders’ Equity for the three month periods ended March 31, 2022 and 20216
   
 Unaudited Condensed Consolidated Statements of Cash Flows for the three month periods ended March 31, 2022 and 20217
   
 Notes to Unaudited Condensed Consolidated Financial Statements8
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations28
   
Item 3.Quantitative and Qualitative Disclosures about Market Risk34
   
Item 4.Controls and Procedures35
   
PART II.OTHER INFORMATION35
   
Item 1. Legal Proceedings35
   
Item 1A.Risk Factors36
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds36
   
Item 3.Defaults Upon Senior Securities36
   
Item 4.Mine Safety Disclosures36
   
Item 5.Other Information36
   
Item 6.Exhibits37
   
 Signatures38

 

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioLife Solutions, Inc.

Unaudited Condensed Consolidated Balance Sheets

 

 
  

March 31,

  

December 31,

 

(In thousands, except per share and share data)

 

2022

  

2021

 

Assets

        

Current assets:

        

Cash and cash equivalents

 $59,463  $69,860 

Restricted cash

  10   10 

Accounts receivable, trade, net of allowance for doubtful accounts of $275 and $275 as of March 31, 2022 and December 31, 2021, respectively

  24,271   23,217 

Inventories, net

  30,200   28,345 

Prepaid expenses and other current assets

  4,757   4,427 

Total current assets

  118,701   125,859 
         

Assets held for rent, net

  9,823   9,809 

Property and equipment, net

  18,259   17,657 

Operating lease right-of-use assets, net

  18,161   18,705 

Financing lease right-of-use assets, net

  404   440 

Long-term deposits and other assets

  265   325 

Investments

  4,372   4,372 

Intangible assets, net

  149,286   152,149 

Goodwill

  224,741   224,741 

Total assets

 $544,012  $554,057 
         

Liabilities and Shareholders Equity

        

Current liabilities:

        

Accounts payable

 $11,711  $14,945 

Accrued expenses and other current liabilities

  6,966   7,142 

Warranty liability

  9,176   9,398 

Lease liabilities, operating, current portion

  2,795   2,758 

Lease liabilities, financing, current portion

  151   149 

Debt, current portion

  557   862 

Contingent consideration, current portion

  3,684   5,127 

Total current liabilities

  35,040   40,381 
         

Contingent consideration, long-term

  3,008   4,900 

Lease liabilities, operating, long-term

  15,917   16,466 

Lease liabilities, financing, long-term

  253   291 

Debt, long-term

  6,313   6,353 

Deferred tax liabilities

  4,888   5,487 

Other long-term liabilities

  73   42 

Total liabilities

  65,492   73,920 
         

Commitments and Contingencies (Note 12)

          
         

Shareholders’ equity:

        

Preferred stock, $0.001 par value; 1,000,000 shares authorized, Series A, 4,250 shares designated, and 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021

  0   0 
Common stock, $0.001 par value; 150,000,000 shares authorized, 42,331,082 and 41,817,503 shares issued and outstanding, respectively, as of March 31, 2022 and December 31, 2021  42   42 

Additional paid-in capital

  591,002   585,397 

Accumulated other comprehensive loss, net of taxes

  (438)  (282)

Accumulated deficit

  (112,086)  (105,020)

Total shareholders’ equity

  478,520   480,137 

Total liabilities and shareholders’ equity

 $544,012  $554,057 

 

The accompanying notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

 

 

BioLife Solutions, Inc.

Unaudited Condensed Consolidated Statements of Operations

 

 
  

Three Months Ended

 
  

March 31,

 

(In thousands, except per share and share data)

 

2022

  

2021

 
         

Product revenue

 $30,388  $13,776 

Service revenue

  3,090   2,204 

Rental revenue

  2,742   867 

Total product, rental, and service revenue

  36,220   16,847 

Costs and operating expenses:

        

Cost of product revenue (exclusive of intangible assets amortization)

  20,384   5,622 

Cost of service revenue (exclusive of intangible assets amortization)

  2,145   1,353 

Cost of rental revenue (exclusive of intangible assets amortization)

  1,917   575 

Research and development

  3,781   1,987 

Sales and marketing

  4,891   2,021 

General and administrative

  11,196   4,830 

Intangible asset amortization

  2,863   933 

Acquisition costs

  11   998 

Change in fair value of contingent consideration

  (3,335)  (491)

Total operating expenses

  43,853   17,828 

Operating loss

  (7,633)  (981)
         

Other income (expense):

        

Change in fair value of warrant liability

  0   (121)

Interest expense, net

  (163)  (16)

Other income

  131   0 

Total other expense, net

  (32)  (137)
         

Loss before income tax benefit

  (7,665)  (1,118)

Income tax benefit

  599   0 

Net loss

 $(7,066) $(1,118)
         

Net loss attributable to common shareholders:

        

Basic and Diluted

 $(7,066) $(1,118)

Net loss per share attributable to common shareholders:

        

Basic and Diluted

 $(0.17) $(0.03)

Weighted average shares used to compute (loss) earnings per share attributable to common shareholders:

        

Basic and Diluted

  42,014,055   33,236,818 

 

The accompanying notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

 

 

BioLife Solutions, Inc.

Unaudited Condensed Consolidated Statements of Comprehensive Loss

 

 
  

Three Months Ended

 
  

March 31,

 

(In thousands)

 

2022

  

2021

 
         

Net loss

 $(7,066) $(1,118)
         

Other comprehensive loss - foreign currency translation adjustment, net of tax

  (156)  0 
         

Comprehensive loss

 $(7,222) $(1,118)

 

The accompanying notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

 

 

BioLife Solutions, Inc.

Unaudited Condensed Consolidated Statements of Shareholders Equity

 

 
  

Three Months Ended March 31, 2022

 
  

Series A

  

Series A

              

Accumulated

         
  

Preferred

  

Preferred

  

Common

  

Common

  

Additional

  

Other

      

Total

 
  

Stock

  

Stock

  

Stock

  

Stock

  

Paid-in

  

Comprehensive

  

Accumulated

  

Shareholders

 

(In thousands, except share data)

 

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Loss

  

Deficit

  

Equity

 

Balance, December 31, 2021

  -  $0   41,817,503  $42  $585,397  $(282) $(105,020) $480,137 

Stock-based compensation

  -   -   -   -   5,399   -   -   5,399 

Stock option exercises

  -   -   129,933   -   257   0   0   257 

Stock issued – on vested RSAs

  0   0   383,646   0   0   0   0   0 

Fees incurred for registration filings

  -   -   -   -   (51)  -   -   (51)

Foreign currency translation

  -   -   -   -   -   (156)  -   (156)

Net loss

  -   0   -   0   0   0   (7,066)  (7,066)

Balance, March 31, 2022

  -  $-   42,331,082  $42  $591,002  $(438) $(112,086) $478,520 

 

 
  

Three Months Ended March 31, 2021

 
  

Series A

  

Series A

              

Accumulated

         
  

Preferred

  

Preferred

  

Common

  

Common

  

Additional

  

Other

      

Total

 
  

Stock

  

Stock

  

Stock

  

Stock

  

Paid-in

  

Comprehensive

  

Accumulated

  

Shareholders

 

(In thousands, except share data)

 

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Loss

  

Deficit

  

Equity

 

Balance, December 31, 2020

  0  $0   33,039,146  $33  $302,598  $-  $(97,385) $205,246 

Stock-based compensation

  -   -   -   -   1,505   -   -   1,505 

Stock option exercises

  -   0   162,865   0   243   0   0   243 

Stock issued – on vested RSAs

  0   0   362,153   0   0   0   0   0 

Cashless exercises of 79,100 warrants

  -   0   70,030   1   2,900   0   0   2,901 

Net loss

  -   0   -   0   0   0   (1,118)  (1,118)

Balance, March 31, 2021

  -  $-   33,634,194  $34  $307,246  $0  $(98,503) $208,777 

 

The accompanying notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

 

 

BioLife Solutions, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

 

 
  

Three Months Ended

March 31,

 

(In thousands)

 

2022

  

2021

 

Cash flows from operating activities

        

Net loss

 $(7,066) $(1,118)

Adjustments to reconcile net loss to net cash (used in) provided by operating activities

        

Depreciation

  1,653   777 

Amortization of intangible assets

  2,863   933 

Stock-based compensation

  5,399   1,505 

Non-cash lease expense

  524   410 
Deferred income tax benefits  (599)  0 

Change in fair value of contingent consideration

  (3,335)  (491)

Change in fair value of warrant liability

  0   121 

Loss on disposal of property and equipment, net

  18   0 

(Gain) / loss on disposal of assets held for rent, net

  (96)  65 

Other

  (17)  1 
         

Change in operating assets and liabilities, net of effects of acquisitions

        

Accounts receivable, trade, net

  (1,083)  (2,663)

Inventories

  (1,855)  (65)

Prepaid expenses and other assets

  (25)  52 

Accounts payable

  (3,231)  604 

Accrued expenses and other current liabilities

  (1,074)  1,689 

Net cash (used in) provided by operating activities

  (7,924)  1,820 
         

Cash flows from investing activities

        

Purchases of property and equipment

  (1,456)  (1,720)

Deposits on property and equipment

  0   (672)
Purchases of assets held for rent  (814)  (2,038)

Proceeds from sale of equipment

  0   3 

Net cash used in investing activities

  (2,270)  (4,427)
         

Cash flows from financing activities

        

Proceeds from equipment loans

  0   1,052 

Payments on equipment loans

  (125)  0 

Fees paid related to issuance of common stock

  (50)  - 

Proceeds from exercise of common stock options

  257   243 

Payments on financed insurance premium

  (305)  0 

Other

  42   (79)

Net cash (used in) provided by financing activities

  (181)  1,216 
         

Net decrease in cash, cash equivalents, and restricted cash

  (10,375)  (1,391)

Cash, cash equivalents, and restricted cash – beginning of period

  69,870   90,456 

Effects of currency translation on cash, cash equivalents, and restricted cash

  (22)  0 

Cash, cash equivalents, and restricted cash – end of period

 $59,473  $89,065 

Non-cash investing and financing activities

        

Cashless exercise of warrants reclassified from warrant liability to common stock

 $0  $2,901 

Equipment acquired under operating leases

 $243  $1,232 

Equipment acquired under finance leases

 $0  $440 

Purchase of property and equipment not yet paid

 $13  $0 

Reclassification of property and equipment, net to assets held for rent, net

 $0  $27 

Cash interest paid

 $91  $0 

 

The accompanying notes are an integral part of these Unaudited Condensed Consolidated Financial Statements.

 

 

BioLife Solutions, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

 

1. Organization and significant accounting policies

 

Business

 

BioLife Solutions, Inc. (“BioLife”, “us”, “we”, “our”, or the “Company”) is a developer, manufacturer, and supplier of a portfolio of bioproduction tools and services including proprietary biopreservation media, automated cell processing fill machines, closed system cryogenic vials, human platelet lysate (“hPL”) growth media, automated thawing devices, cloud-connected shipping containers, ultra-low temperature mechanical freezers, cryogenic and controlled rate freezers and biological and pharmaceutical materials storage. Our CryoStor® freeze media and HypoThermosol® hypothermic storage media are optimized to preserve cells in the regenerative medicine market. These novel biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. Our Sexton cell processing product line includes hPL for cell expansion reducing risk and improving downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal® cryogenic vials that are purpose-built rigid containers used in cell and gene therapy (“CGT”) that can be filled manually or with high throughput systems, and automated cell processing machines that bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination. Our ThawSTAR® product line is comprised of a family of automated thawing devices for frozen cell and gene therapies packaged in cryovials and cryobags. These products help administer 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. Our cryogenic freezer technology provides for controlled rate freezing and cryogenic storage of biologic materials. Our ultra-low temperature mechanical freezers allow biological materials and vaccines to be stored at temperatures which range from negative 20℃ to negative 86℃. Our evo® shipping containers provide cloud-connected passive storage and transport containers for temperature-sensitive biologics and pharmaceuticals. Our biological and pharmaceutical materials storage services provide facilities that allow for real-time tracking of biologic materials and vaccines that can be stored at a wide range of temperatures.

 

Use of estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

Significant estimates and assumptions by management affect the Company’s net realizable value of inventory, fair value of warrant liability, valuation of market based awards, valuations and purchase price allocations related to investments and business combinations, expected future cash flows including growth rates, discount rates, terminal values and other assumptions and estimates used to evaluate the recoverability of long-lived assets, estimated fair values of intangible assets and goodwill, amortization methods and periods, warranty reserves, certain accrued expenses, share-based compensation, contingent consideration from business combinations, and the recoverability of the Company’s deferred tax assets and the related valuation allowance.

 

The Company regularly assesses these estimates; however, actual results could differ materially from these estimates. Changes in estimates are recorded in the period in which they become known. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances.

 

Basis of presentation

 

The Unaudited Condensed Consolidated Financial Statements included herein have been prepared by BioLife in accordance with U.S. GAAP and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”), for Quarterly Reports on Form 10-Q and Article 10 of Regulation S-X and do not include all of the information and footnote disclosures required by U.S. GAAP. These Unaudited Condensed Consolidated Financial Statements should be read in conjunction with the Audited Consolidated Financial Statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K as of and for the fiscal year ended December 31, 2021.

 

The Unaudited Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries, SAVSU Technologies, Inc. (“SAVSU” acquired on August 8, 2019), Arctic Solutions, Inc. doing business as Custom Biogenic Systems (“CBS” acquired on November 12, 2019), SciSafe Holdings, Inc. (“SciSafe” acquired on October 1, 2020), Global Cooling, Inc. doing business as Stirling Ultracold (“Global Cooling” or “GCI” acquired on May 3, 2021), and Sexton Biotechnologies, Inc. (“Sexton” acquired on September 1, 2021). All intercompany accounts and transactions have been eliminated in consolidation.

 

8

 

In the opinion of management, the accompanying Unaudited Condensed Consolidated Financial Statements include all adjustments, consisting of only normal, recurring adjustments necessary for a fair presentation of the financial position, results of operations, and cash flows. The results of operations for the interim periods presented are not necessarily indicative of results to be expected for the entire year.

 

Foreign currency translation

 

The Company translates items presented on its Unaudited Condensed Consolidated Balance Sheet and Unaudited Condensed Consolidated Statements of Operations into U.S. dollars. For the Company’s subsidiaries that operate in a local currency functional environment, all assets and liabilities are translated into U.S. dollars using current exchange rates at the balance sheet date; revenue and expenses are translated using average exchange rates in effect during each period. Resulting translation adjustments are reported as a separate component of Accumulated Other Comprehensive Loss in the Unaudited Condensed Consolidated Statements of Shareholders' Equity.

 

Segment reporting

 

The Company views its operations and makes decisions regarding how to allocate resources and manages its business as one reportable segment and one reporting unit. The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating and evaluating financial performance.

 

Significant accounting policies

 

There have been no significant changes to the accounting policies during the March 31, 2022, as compared to the significant accounting policies described in our Annual Report on Form 10-K.

 

Liquidity and capital resources

 

On March 31, 2022 and December 31, 2021, we had $59.5 million and $69.9 million in cash and cash equivalents, respectively. Based on our current expectations with respect to our future revenue and expenses, we believe that our current level of cash and cash equivalents will be sufficient to meet our liquidity needs for at least the next twelve months from the date of the filing of this Form 10-Q. However, the Company may choose to raise additional capital through a debt or equity financing in order to pursue additional acquisition or strategic investment opportunities. Additional capital, if required, may not be available on reasonable terms, if at all.

 

Risks and uncertainties

 

COVID-19 pandemic

 

Our domestic and international operations have been and continue to be affected by the ongoing global pandemic of a novel strain of coronavirus (“COVID-19”) and the resulting volatility and uncertainty it has caused in the U.S. and international markets. Many businesses and countries, including the U.S., continue to apply preventative and precautionary measures to mitigate the spread of the virus including government orders and other restrictions on the conduct of business operations.

 

In the three months ended March 31, 2022 and year ended December 31, 2021, we experienced supply chain disruptions due to the effects of COVID-19 on our suppliers of sheet metal and electronic components that incorporate semiconductor chips. These supply chain disruptions decreased our profitability as a result of increased supplier pricing and production stoppages. We cannot be assured that a continued or prolonged global pandemic will not have other negative impacts on our manufacturing and shipping processes or our product costs. The extent to which the COVID-19 pandemic affects our future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including the recurrence, severity and/or duration of the ongoing pandemic, and current or future domestic and international actions to contain and treat COVID-19.

 

The Company may also experience other negative impacts of the COVID-19 outbreak such as the lack of availability of the Company’s key personnel, additional temporary closures of the Company’s office or the facilities of the Company’s business partners, customers, third party service providers or other vendors, the inability to travel to market and sell our products, and the interruption of the Company’s supply chain, distribution channels, liquidity and capital or financial markets.

 

Any disruption and volatility in the global capital markets as a result of the pandemic may increase the Company’s cost of capital and adversely affect the Company’s ability to access financing when and on terms that the Company desires. In addition, a potential recession resulting from the spread of COVID-19 could materially affect the Company’s business, especially if a recession results in higher unemployment causing potential patients to not have access to health insurance.

 

The ultimate extent to which the COVID-19 pandemic and its repercussions impact the Company’s business will depend on future developments, which are highly uncertain. However, the foregoing and other continued disruptions to the Company’s business as a result of COVID-19 could result in a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.

 

9

 

Concentrations of credit risk and business risk

 

Significant customers are those that represent more than 10% of the Company’s total revenues or gross accounts receivable balances for the periods and as of each balance sheet date presented. For each significant customer, revenue as a percentage of total revenues and gross accounts receivable as a percentage of total gross accounts receivable as of the periods presented were as follows:

 

  

Accounts Receivable

  

Revenue

 
  

March 31,

  

December 31,

  

March 31,

 
  

2022

  

2021

  

2022

  

2021

 

Customer A

  16

%

  10

%

  *   * 

Customer B

  14

%

  *   20

%

  * 

Customer C

  *   *   11

%

  * 

 

* less than 10%

 

Revenue from foreign customers is denominated in United States dollars or euros.

 

The following table represents the Company’s total revenue by geographic area (based on the location of the customer):

 

  

Three Months Ended

 
  

March 31,

 

Revenue by customers geographic locations

 

2022

  

2021

 

United States

  79

%

  75

%

Canada

  1

%

  10

%

Europe, Middle East, Africa (EMEA)

  16

%

  12

%

Other

  4

%

  3

%

Total revenue

  100

%

  100

%

 

In the three months ended March 31, 2022 and 2021, no suppliers accounted for more than 10% of purchases.

 

As of March 31, 2022 and 2021 no suppliers accounted for more than 10% of our accounts payable.

 

Recent accounting pronouncements 

 

In March 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2022-02 Financial Instruments-Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures. ASU 2022-02 eliminates the accounting guidance for troubled debt restructurings and requires disclosure of current-period gross write-offs by year of loan origination. Additionally, ASU 2022-02 updates the accounting for credit losses under ASC 326 and adds enhanced disclosures with respect to loan refinancings and restructurings in the form of principal forgiveness, interest rate concessions, other-than-insignificant payment delays, or term extensions when the borrower is experiencing financial difficulties. ASU 2022-02 is effective for fiscal years beginning after December 15, 2022 and early adoption is permitted. We are currently evaluating the impact ASU 2022-02 will have on our consolidated financial statements.

 

10

 

 

2. Fair value measurement

 

In accordance with FASB ASC Topic 820, Fair Value Measurements and Disclosures, (“ASC Topic 820”), the Company measures its financial instruments at fair value on a recurring basis. The carrying values of certain of our financial instruments including cash and cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value because of their short maturities. The carrying values of our long-term debt, which is classified within Level 2 in the fair value hierarchy, approximates fair value as our borrowings with lenders are at interest rates that approximate market rates for comparable loans. The Company also measures certain assets and liabilities at fair value on a non-recurring basis when applying acquisition accounting. ASC Topic 820 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC Topic 820 establishes a three-tier value fair hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1 – Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets or liabilities.

 

Level 2 – Observable inputs other than quoted prices included in Level 1 for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3 – Unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability.

 

The fair value of the CBS Contingent Consideration Liability was initially valued based on unobservable inputs using a Monte Carlo simulation. These inputs included the estimated amount and timing of projected future revenue, a discount rate of 26.0%, a risk-free rate of approximately 1.74% and revenue volatility of 70%. Significant increases (decreases) in any of those inputs in isolation would result in a significantly higher (lower) fair value measurement. Generally, changes used in the assumptions for projected future revenue and revenue volatility would be accompanied by a directionally similar change in the fair value measurement. Conversely, changes in the discount rate would be accompanied by a directionally opposite change in the related fair value measurement. However, due to the contingent consideration having a maximum payout amount, changes in these assumptions would not affect the fair value of the contingent consideration if they increase (decrease) beyond certain amounts. Subsequent to the acquisition date, at each reporting period, the Contingent Consideration Liability is re-measured to fair value with changes recorded in the Change in Fair Value of Contingent Consideration in the Unaudited Condensed Consolidated Statements of Operations. During the most recent re-measurement of the Contingent Consideration Liability as of December 31, 2021, the Company used a discount rate of 21.0%, a risk-free rate of 0.23% and revenue volatility of 63%. This Contingent Consideration Liability is included in the Unaudited Condensed Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021 in the amount of $140,000.

 

The fair value of the SciSafe Contingent Consideration Liability was initially valued based on unobservable inputs using a Monte Carlo simulation. These inputs included the estimated amount and timing of projected future revenue, a discount rate of 4.5%, a risk-free rate of approximately 0.20%, asset volatility of 60%, and revenue volatility of 15%. Significant increases (decreases) in any of those inputs in isolation would result in a significantly higher (lower) fair value measurement. Generally, changes used in the assumptions for projected future revenue and revenue volatility would be accompanied by a directionally similar change in the fair value measurement. Conversely, changes in the discount rate would be accompanied by a directionally opposite change in the related fair value measurement. However, due to the contingent consideration having a maximum payout amount, changes in these assumptions would not affect the fair value of the contingent consideration if they increase (decrease) beyond certain amounts. At the acquisition date, the contingent consideration was determined to have a fair value of $3.7 million. Subsequent to the acquisition date, the Contingent Consideration Liability was re-measured to fair value with changes recorded in the Change in Fair Value of Contingent Consideration in the Unaudited Condensed Consolidated Statements of Operations. During the most recent re-measurement of the Contingent Consideration Liability as of March 31, 2022, the Company used a discount rate of 9.9%, a risk-free rate of approximately 2.3%, asset volatility of 71%, and revenue volatility of 31%. This Contingent Consideration Liability is included in the Unaudited Condensed Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021 in the amounts of $6.6 million and $9.9 million, respectively. The changes in fair value of contingent consideration of $3.3 million and $491,000 associated with this liability are included within the Change in Fair Value of Contingent Consideration in the Unaudited Condensed Consolidated Statements of Operations for the three months ended March 31, 2022 and 2021, respectively.

 

For the warrant liability, the significant Level 3 inputs included the contractual remaining term of the warrants and the volatility of the Company’s common stock. For the estimated term of the warrants, we used the actual terms of the warrants, which expired March 25, 2021. On that date, all remaining warrants were exercised via a “cashless” exercise and the warrant liability was revalued to its intrinsic value, as the Company’s stock price was observable as of that date.

 

There were no remeasurements to fair value during the three months ended March 31, 2022 of financial assets and liabilities that are not measured at fair value on a recurring basis.

 

11

 

The following tables set forth the Company’s financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2022 and December 31, 2021, based on the three-tier fair value hierarchy:

 

(In thousands)

 

As of March 31, 2022

 

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets:

                

Money market accounts

 $52,380  $0  $0  $52,380 

Total

  52,380   0   0   52,380 

Liabilities:

                

Contingent consideration - business combinations

  0   0   6,692   6,692 

Debt

  0   6,870   0   6,870 

Total

 $0  $6,870  $6,692  $13,562 

 

As of December 31, 2021

 

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets:

                

Money market accounts

 $63,873  $0  $0  $63,873 

Total

  63,873   0   0   63,873 

Liabilities:

                

Contingent consideration - business combinations

  0   0   10,027   10,027 

Debt

  0   7,215   0   7,215 

Total

 $0  $7,215  $10,027  $17,242 

 

The fair values of money market funds classified as Level 1 were derived from quoted market prices as active markets for these instruments exist. The fair values of investments and contingent consideration classified as Level 3 were derived from management assumptions (see Note 1 – “Organization and Significant Accounting Policies.”) There have been no transfers of assets or liabilities between the fair value measurement levels.

 

The following table presents the changes in fair value of contingent consideration liabilities which are measured using Level 3 inputs:

 

  

Three Months Ended

March 31,

 

(In thousands)

 

2022

  

2021

 

Beginning balance

 $10,027  $7,152 

Change in fair value recognized in net loss

  (3,335)  (491)

Ending balance

 $6,692  $6,661 

 

The following table presents the changes in fair value of warrant liabilities which are measured using Level 3 inputs:

 

  

Three Months Ended

March 31,

 

(In thousands)

 

2022

  

2021

 

Beginning balance

 $0  $2,780 

Exercised warrants

  0   (2,901)

Change in fair value recognized in net loss

  0   121 

Ending balance

 $0  $0 

 

 

 

3. Acquisitions

 

Sexton acquisition

 

General terms and effects

 

On August 9, 2021, BioLife entered into an Agreement and Plan of Merger (the “Sexton Merger Agreement”) with BLFS Merger Sub, Inc., a Delaware corporation (“Sexton Merger Sub”), Fortis Advisors LLC, in its capacity as the representative of the stockholders of Sexton (the “Sexton Seller Representative”) and Sexton, a Delaware corporation. The acquisition strengthens BioLife’s offerings in the cell and gene therapy and broader biopharma markets.

 

12

 

On September 1, 2021, the Company completed the merger of Sexton Merger Sub with and into Sexton and Sexton became a wholly-owned subsidiary of the Company (the “Sexton Merger”). As consideration for the Sexton Merger (the “Sexton Merger Consideration”), holders of common stock, preferred stock and options of Sexton, other than the Company (collectively, the “Sexton Participating Holders”), are entitled to receive an aggregate of 530,502 newly issued shares of the Company’s common stock, subject to certain post-closing adjustments, of which 477,452 shares of Common Stock were issued to the Sexton Participating Holders at the Closing, and 53,050 shares of Common Stock, or approximately 10% of the Merger consideration, were deposited into an escrow account for indemnification and post-closing purchase price adjustment purposes. Prior to the merger, the Company held preferred stock in Sexton, which was accounted for using a measurement alternative that measures the securities at cost minus impairment, if any, plus or minus changes resulting from observable process changes in orderly transactions for identical or similar investments of the same issuer. The Company accounted for the merger as a step acquisition, which required remeasurement of the Company’s existing ownership in Sexton to fair value prior to completing the acquisition method of accounting. Using step acquisition accounting, the Company increased the value of its existing equity interest to its fair value, resulting in the recognition of a non-cash gain of $6.5 million. The Company utilized a market-based valuation approach to determine the fair value of the existing equity interest based on the total merger consideration offered and the Company’s stock price at acquisition.

 

Total consideration transferred (in thousands, except number of shares and stock price):

 

Merger consideration shares

  530,502 

BioLife stock price (as of September 1, 2021)

 $60.50 

Value of issued shares

 $32,095 

plus: Fair value of BioLife’s existing investment in Sexton

 $7,951 

less: Net working capital adjustment

 $(118)

Merger Consideration

 $39,928 

 

Transaction costs related to the acquisition are expensed as incurred and are not included in the calculation of consideration transferred.

 

Fair value of net assets acquired

 

Under the acquisition method of accounting, the assets acquired and liabilities assumed from Sexton were calculated as of the merger date, at their respective fair values, and consolidated with those of BioLife. The gross contractual accounts receivable acquired in the acquisition was $509,000. Of the acquired accounts receivable, $17,000 is estimated to be uncollectable. The fair value calculations required critical estimates, including, but not limited to, future expected cash flows, revenue and expense projections, discount rates, revenue volatility, and royalty rates.

 

The table below represents the fair value of the net assets acquired and liabilities assumed, which were recorded as of the merger date (amounts in thousands).

 

Cash

 $1,516 

Accounts receivable, net

  492 

Inventory

  1,310 

Prepaid expenses and other current assets

  670 

Property, plant and equipment, net

  737 

Operating lease right-of-use assets, net

  470 

Developed technology

  4,132 

Customer relationships

  2,276 

Tradenames

  2,324 

Non-compete agreements

  90 

Goodwill

  28,470 

Accounts payable

  (291

)

Lease liabilities, operating

  (470

)

Deferred tax liability

  (1,482

)

Other liabilities

  (316

)

Fair value of net assets acquired

 $39,928 

 

We recorded a measurement period adjustment in the fourth quarter of the year ended December 31, 2021 of $198,000 to the fair value of goodwill and the deferred tax liability. This adjustment related to the tax attributes of the business combination.

 

13

 

The fair value of Sexton’s identifiable intangible assets and useful lives are as follows (amounts in thousands, except years):

 

  

Fair Value

  

Useful

Life (Years)

 

Developed technology

 $4,132   5-9 

Customer relationships

  2,276    2  

Tradenames

  2,324    11  

Non-compete agreements

  90    1  

Total identifiable intangible assets

 $8,822       

 

Fair value measurement methodologies used to calculate the value of any asset can be broadly classified into one of three approaches, referred to as the cost, market and income approaches. In any fair value measurement analysis, all three approaches must be considered, and the approach or approaches deemed most relevant will then be selected for use in the fair value measurement of that asset. The estimated fair values of developed technology were estimated using a multi-period excess earnings approach. The estimated fair values of customer relationships and non-compete agreements were estimated using a “with and without” approach, comparing projected cash flows under scenarios assuming the customer relationships and non-compete agreements were and were not in place. The estimated fair value of the tradenames is based on the relief from royalty method, which estimates the value of the trade names based on the hypothetical royalty payments that are saved by owning the asset.

 

Some of the more significant assumptions inherent in the development of intangible asset fair values, from the perspective of a market participant, include, but are not limited to (i) the amount and timing of projected future cash flows (including revenue and expenses), (ii) the discount rate selected to measure the risks inherent in the future cash flows, (iii) the assessment of the asset’s life cycle, and (iv) the competitive trends impacting the asset.

 

Acquired goodwill

 

The goodwill of $28.5 million represents future economic benefits expected to arise from synergies from combining operations and commercial organizations to increase market presence and the extension of existing customer relationships. The goodwill recorded is not deductible for income tax purposes.

 

Global Cooling acquisition

 

General terms and effects

 

On March 19, 2021, the Company entered into an Agreement and Plan of Merger (the “GCI Merger Agreement”) with BLFS Merger Subsidiary, Inc., a Delaware corporation (“GCI Merger Sub”), Global Cooling, a Delaware corporation and Albert Vierling and William Baumel, in their capacity as the representatives of the stockholders of GCI (collectively, the “GCI Seller Representative”). The acquisition strengthens BioLife’s offerings in the cell and gene therapy and broader biopharma markets.

 

On May 3, 2021, pursuant to the GCI Merger Agreement, subject to the terms and conditions set forth therein, the transactions contemplated by the GCI Merger Agreement were consummated (the “GCI Closing”), GCI Merger Sub merged with and into GCI (the “GCI Merger” and, together with other transactions contemplated by the GCI Merger Agreement, the “GCI Transactions”), with GCI continuing as the surviving corporation in the GCI Merger and a wholly-owned subsidiary of the Company. In the GCI Merger, all of the issued and outstanding shares of capital stock of GCI immediately prior to the filing of the Certificate of Merger with the Secretary of State of the State of Delaware (other than those properly exercising any applicable dissenter’s rights under Delaware law) were converted into the right to receive the GCI Merger Consideration (as defined below). The Company paid the GCI Merger Consideration to the holders of common stock and preferred stock of GCI (collectively, the “GCI Stockholders”).

 

Merger consideration

 

The aggregate merger consideration paid pursuant to the GCI Merger Agreement to the GCI Stockholders was 6,646,870 newly issued shares of common stock, provided, however, that the GCI Merger Consideration otherwise payable to GCI Stockholders is subject to the withholding of the GCI Escrow Shares (as defined below) and is subject to reduction for indemnification obligations. The GCI Merger Consideration allocable to one GCI stockholder was reduced by 10,400 shares to satisfy an outstanding note receivable of $374,000. In accordance with ASC 805, the Company recognized the settlement of pre-existing relationships in the forms of cash deposits, trade receivables, and trade payables, which are included in the consideration transferred. The GCI Merger Consideration is not subject to any purchase price adjustments.

 

Total consideration transferred (in thousands, except number of shares, stock price, and consideration percentage):

 

BioLife shares outstanding (as of March 19, 2021)

  33,401,359 

Merger consideration percentage

  19.9%

Merger consideration shares

  6,646,870 

less: Merger consideration shares withheld to satisfy outstanding GCI stockholder obligations to GCI

  10,400 

Subtotal

  6,636,470 

BioLife stock price (as of May 3, 2021)

 $35.07 

Value of issued shares

 $232,741 

plus: Settlement of BioLife prepaid deposits

 $2,152 

plus: Net settlement of BioLife accounts receivable

 $16 

Merger Consideration

 $234,909 

 

14

 

Transaction costs related to the acquisition are expensed as incurred and are not included in the calculation of consideration transferred.

 

Escrow shares

 

At the GCI Closing, approximately nine percent (9%) of the GCI Merger Consideration (the “Escrow Shares”, along with any other dividends, distributions or other income on the GCI Escrow Shares, the “GCI Escrow Property”) otherwise issuable to the GCI Stockholders (allocated pro rata among the GCI Stockholders based on the GCI Merger Consideration otherwise issuable to them at the GCI Closing), was deposited into a segregated escrow account in accordance with an escrow agreement to be entered into in connection with the GCI Transactions (the “GCI Escrow Agreement”).

 

The GCI Escrow Property will be held for a period of up to twenty-four (24) months after the GCI Closing as the sole and exclusive source of payment for any post-GCI Closing indemnification claims (other than fraud claims), unless earlier released in accordance with the terms of the GCI Escrow Agreement.

 

Fair value of net assets acquired

 

Under the acquisition method of accounting, the assets acquired and liabilities assumed from Global Cooling were calculated as of the merger date, at their respective fair values, and consolidated with those of BioLife. The gross contractual accounts receivable acquired in the acquisition was $7.1 million. Of the acquired accounts receivable, $53,000 was estimated to be uncollectable. The fair value calculations required critical estimates, including, but not limited to, future expected cash flows, revenue and expense projections, discount rates, revenue volatility, and royalty rates.

 

The table below represents the fair value of the net assets acquired and liabilities assumed, which were recorded as of the merger date (amounts in thousands).

 

Cash

 $43 

Accounts receivable, net

  7,076 

Inventory

  15,547 

Prepaid expenses and other current assets

  639 

Property, plant and equipment, net

  3,512 

Operating lease right-of-use assets, net

  1,741 

Financing lease right-of-use assets, net

  114 

Long-term deposits and other assets

  4 

Developed technology

  18,140 

Customer relationships

  7,020 

Tradenames

  26,640 

Non-compete agreements

  1,240 

In-process research and development

  67,440 

Goodwill

  137,822 

Accounts payable

  (9,837

)

Line of credit

  (4,231

)

Lease liabilities, operating

  (1,880

)

Lease liabilities, financing

  (114

)

Long-term debt

  (4,410

)

Deferred tax liability

  (24,133

)

Other liabilities

  (7,464

)

Fair value of net assets acquired

 $234,909 

 

We recorded a measurement period adjustment in the fourth quarter of the year ended December 31, 2021 of $607,000 to the fair value of goodwill and the deferred tax liability. This adjustment related to the tax attributes of the business combination.

 

15

 

The fair value of Global Cooling’s identifiable intangible assets and useful lives are as follows (amounts in thousands, except years):

 

  

Fair Value

  

Useful

Life (Years)

 

Developed technology

 $18,140   6 

Customer relationships

  7,020   12 

Tradenames

  26,640   15 

Non-compete agreements

  1,240   4 

In-process research and development

  67,440   N/A 

Total identifiable intangible assets

 $120,480     

 

Fair value measurement methodologies used to calculate the value of any asset can be broadly classified into one of three approaches, referred to as the cost, market and income approaches. In any fair value measurement analysis, all three approaches must be considered, and the approach or approaches deemed most relevant will then be selected for use in the fair value measurement of that asset. The fair values of developed technology and in-process research and development were estimated using a multi-period excess earnings approach. The fair values of customer relationships were estimated using the “distributor method”. The fair value of the tradenames is based on the relief from royalty method, which estimates the value of the trade names based on the hypothetical royalty payments that are saved by owning the asset. The fair values of non-compete agreements were estimated using a “with and without” approach, comparing projected cash flows under scenarios assuming the non-compete agreements were and were not in place. The fair value of inventory and property, plant and equipment were determined using the “market approach”.

 

Some of the more significant assumptions inherent in the development of intangible asset fair values, from the perspective of a market participant, include, but are not limited to (i) the amount and timing of projected future cash flows (including revenue and expenses), (ii) the discount rate selected to measure the risks inherent in the future cash flows, (iii) the assessment of the asset’s life cycle, and (iv) the competitive trends impacting the asset.

 

Acquired goodwill

 

The goodwill of $137.8 million represents future economic benefits expected to arise from synergies from combining operations and commercial organizations to increase market presence and the extension of existing customer relationships. The goodwill recorded is not deductible for income tax purposes.

 

Pro forma presentation

 

The following unaudited pro forma financial information presents the combined results of operations of Sexton as if the acquisition had occurred on January 1, 2021 after giving effect to certain pro forma adjustments. These pro forma adjustments include intangible amortization, stock-based compensation expense and salary expense related to a key employee, and the income tax effect of the adjustments made:

 

(In thousands)

 

Three Months Ended

March 31, 2021

(unaudited)

 

Total revenue

 $17,855 

Net (loss) income

 $(1,924)

 

The following unaudited pro forma financial information presents the combined results of operations of Global Cooling as if the acquisition had occurred on January 1, 2021 after giving effect to certain pro forma adjustments. These pro forma adjustments include intangible amortization, amortization of increased inventory basis, depreciation expense, lease expense, transaction costs, interest expense, stock-based compensation expense and salary expense related to a key employee, and the income tax effect of the adjustments made:

 

(In thousands)

 

Three Months Ended

March 31, 2021

(unaudited)

 

Total revenue

 $34,949 

Net income (loss)

 $(10,562)

 

16

 

 

4. Inventory

 

Inventory consists of the following as of March 31, 2022 and December 31, 2021:

 

(In thousands)

 

2022

  

2021

 

Raw materials

 $16,634  $17,252 

Work in progress

  5,005   5,015 

Finished goods

  8,561   6,078 

Total

 $30,200  $28,345 

 

 

 

5. Assets held for rent

 

Assets held for rent consist of the following as of March 31, 2022 and December 31, 2021:

 

(In thousands)

 

2022

  

2021

 

Shippers placed in service

 $6,032  $5,645 

Fixed assets held for rent

  4,686   4,040 

Accumulated depreciation

  (3,070)  (2,272)

Net

  7,648   7,413 

Shippers and related components in production

  2,175   2,396 

Total

 $9,823  $9,809 

 

Shippers and related components in production include shippers complete and ready to be deployed and placed in service upon a customer order, shippers in the process of being assembled, and components available to build shippers. We recognized $896,000 and $184,000 in depreciation expense related to assets held for rent during the three months ended March 31, 2022 and 2021, respectively.

 

 

 

6. Goodwill and intangible assets 

 

Goodwill

 

Goodwill represents the difference between the purchase price and the estimated fair value of identifiable assets acquired and liabilities assumed. Goodwill acquired in a business combination is determined to have an indefinite useful life and is not amortized, but instead is tested for impairment at least annually in accordance with ASC 350. The Company has not identified any triggering events which indicate an impairment of goodwill in the three months ended March 31, 2022.

 

Intangible assets

 

Intangible assets, net consisted of the following as of March 31, 2022 and December 31, 2021:

 

(In thousands, except weighted average useful life)

 

March 31, 2022

     

Intangible assets:

 

Gross Carrying Value

  

Accumulated Amortization

  

Net Carrying Value

  

Weighted Average Useful Life (in years)

 

Customer Relationships

 $17,516  $(2,376) $15,140   10.1 

Tradenames

  35,574   (2,939)  32,635   13.6 

Technology - acquired

  41,942   (9,278)  32,664   5.6 

Non-compete agreements

  1,990   (583)  1,407   2.8 

In-process research and development⁽¹⁾

  67,440   -   67,440   N/A 

Total intangible assets

 $164,462  $(15,176) $149,286   9.6 

 

(In thousands, except weighted average useful life)

 

December 31, 2021

     

Intangible assets:

 

Gross Carrying

Value

  

Accumulated Amortization

  

Net Carrying

Value

  

Weighted

Average Useful

Life (in years)

 

Customer Relationships

 $17,516  $(1,776) $15,740   10.3 

Tradenames

  35,574   (2,306)  33,268   13.8 

Technology - acquired

  41,942   (7,789)  34,153   5.9 

Non-compete agreements

  1,990   (442)  1,548   3.0 

In-process research and development⁽¹⁾

  67,440   0   67,440   N/A 

Total intangible assets

 $164,462  $(12,313) $152,149   9.8 

 

(1) In-process R&D represents the fair value of incomplete research and development. We will amortize the asset upon completion of development.

 

17

 

Amortization expense for definite-lived intangible assets was $2.9 million and $933,000 for the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, the Company expects to record the following amortization expense for definite-lived intangible assets:

 

(In thousands)

 

Amortization

 

For the Years Ending December 31,

 

Expense

 

2022 (9 months remaining)

 $8,558 

2023

  10,951 

2024

  10,126 

2025

  9,748 

2026

  9,346 

Thereafter

  33,117 

Total

 $81,846 

 

 

 

7. Long-term debt

 

Long-term debt consisted of the following as of March 31, 2022 and December 31, 2021:

 

(In thousands)

 

Maturity Date

 

Interest Rate

  

March 31,

2022

  

December 31,

2021

 

2022 term loan 1

 

Sep-24

  4.0% $1,750  $1,750 

2022 term loan 2

 

Various

  4.0%  2,896   2,813 

Insurance premium financing

 

Apr-22

  4.0%  69   373 

Freezer equipment loan

 

Dec-25

  5.7%  572   612 

Manufacturing equipment loans

 

Oct-25

  5.7%  333   355 

Freezer installation loan

 

Various

  6.3%  1,271   1,334 

Other loans

 

Various

 

 

Various   8   9 

Total debt, excluding unamortized debt issuance costs

      6,899   7,246 

Less: unamortized debt issuance costs

      (29)  (31)

Total debt

      6,870   7,215 

Less: current portion

      (557)  (862)

Total long-term debt

     $6,313  $6,353 

 

The 2022 term loans are secured by substantially all assets of Global Cooling. Equipment loans are secured by the financed equipment.

 

As of March 31, 2022, the scheduled maturities of loans payable for each of the next five years and thereafter were as follows:

 

(In thousands)

 

Amount

 

2022 (9 months remaining)

 $432 

2023

  813 

2024

  2,294 

2025

  543 

2026

  221 

Thereafter

  2,596 

Total debt, excluding unamortized debt issuance costs

  6,899 

Less: unamortized debt issuance costs

  (29)

Total debt

 $6,870 

 

18

 

 

8. Share-based compensation  

 

Service vesting-based stock options

 

The following is a summary of service vesting-based stock option activity for the three months ended March 31, 2022, and the status of service vesting-based stock options outstanding as of March 31, 2022:

 

  

Three Months Ended

March 31, 2022

 
  

Shares

  

Wtd. Avg.

Exercise Price

 

Outstanding as of beginning of year

  624,531  $2.13 

Exercised

  (129,933)  1.98 

Outstanding as of March 31, 2022

  494,598  $2.17 
         

Stock options exercisable as of March 31, 2022

  494,598  $2.17 

 

We recognized stock compensation expense related to service-based options of zero and $9,000 during the three months ended March 31, 2022 and 2021. As of March 31, 2022, there was $10.2 million of aggregate intrinsic value of outstanding and exercisable service vesting-based stock options. Intrinsic value is the total pretax intrinsic value for all “in-the-money” options (i.e., the difference between the Company’s closing stock price on the last trading day of the year and the exercise price, multiplied by the number of shares) that would have been received by the option holders had all option holders exercised their options on March 31, 2022. This amount will change based on the fair market value of the Company’s stock. Intrinsic value of service vesting-based awards exercised during the three months ended March 31, 2022 and 2021 was $3.6 million and $3.3 million, respectively. There were 0 service based-vesting options granted during the three months ended March 31, 2022 and 2021. The weighted average remaining contractual life of service vesting-based options outstanding and exercisable as of March 31, 2022 is 3.5 years. There were 0 unrecognized compensation costs for service vesting-based stock options as of March 31, 2022.

 

Performance-based stock options

 

No stock compensation expense was recognized during the three months ended March 31, 2022 and 2021 related to performance-based options. The intrinsic value of performance-based awards exercised during the three months ended March 31, 2022 and 2021 was NaN and $2.9 million, respectively. There were 0 stock options granted to employees and non-employee directors in the three months ended March 31, 2022 and 2021.

 

Restricted stock

 

Service vesting-based restricted stock

 

The following is a summary of service vesting-based restricted stock activity for the three months ended March 31, 2022, and the status of unvested service vesting-based restricted stock outstanding as of March 31, 2022:

 

  

Three Months Ended

 
  

March 31, 2022

 
  

Shares

  

Wtd. Avg.

Grant Date

Fair Value

 

Outstanding as of beginning of year

  1,212,783  $37.48 

Granted

  301,011   26.38 

Vested

  (165,366)  37.48 

Forfeited

  (14,642)  44.37 

Non-vested as of March 31, 2022

  1,333,786  $34.90 

 

19

 

The aggregate fair value of the service vesting-based awards granted during the three months ended March 31, 2022 and 2021 was $7.9 million and $2.2 million, respectively. The aggregate fair value of the service vesting-based awards that vested during the three months ended March 31, 2022 and 2021 was $5.0 million and $2.6 million, respectively.

 

We recognized stock compensation expense of $4.8 million and $1.4 million related to service vesting-based awards during the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, there was $41.4 million in unrecognized compensation costs related to service vesting-based awards. We expect to recognize those costs over 2.9 years.

 

Market-based restricted stock

 

The following is a summary of market-based restricted stock activity under our stock option plan for the three months ended March 31, 2022 and the status of market-based restricted stock outstanding as of March 31, 2022:

 

  

Three Months Ended

March 31, 2022

 
  

Shares

  

Wtd. Avg.

Grant Date

Fair Value

 

Outstanding as of beginning of year

  139,756  $19.86 

Granted

  349,568   22.66 

Vested

  (218,280)  10.95 

Non-vested as of March 31, 2022

  271,044  $30.64 

 

On March 25, 2020, the Company granted 109,140 shares of market-based stock to its executives in the form of restricted stock. The shares granted contain a market condition based on Total Shareholder Return (“TSR”). The TSR market condition measures the Company’s performance against a peer group. On February 24, 2022, the Company’s Compensation Committee determined the TSR attainment was 200% of the targeted shares and 218,280 shares were granted and immediately vested to the executives of the Company based on our total shareholder return during the period beginning on January 1, 2020 through December 31, 2021 as compared to the total shareholder return of 20 of our peers. The fair value of this award was determined at the grant date using a Monte Carlo simulation with the following assumptions: a historical volatility of 78%, 0% dividend yield and a risk-free interest rate of 0.3%. The historical volatility was based on the most recent 2-year period for the Company and correlated with the components of the peer group. The stock price projection for the Company and the components of the peer group assumes a 0% dividend yield. This is mathematically equivalent to reinvesting dividends in the issuing entity over the performance period. The risk-free interest is based on the yield on the U.S. Treasury Strips as of the Measurement Date with a maturity consistent with the 2-year term associated with the market condition of the award. The fair value of this award of $1.2 million was expensed on a straight-line basis over the grant date to the vesting date of December 31, 2021.

 

On February 8, 2021, the Company granted 30,616 shares of market-based stock to its executives in the form of restricted stock. The shares granted contain a market condition based on TSR. The TSR market condition measures the Company’s performance against a peer group. The market-based restricted stock awards will vest as to between 0% and 200% of the number of restricted shares granted to each recipient based on our total shareholder return during the period beginning on January 1, 2021 through December 31, 2022 as compared to the total shareholder return of 20 of our peers. The fair value of this award was determined using a Monte Carlo simulation with the following assumptions: a historical volatility of 68%, 0% dividend yield and a risk-free interest rate of 0.1%. The historical volatility was based on the most recent 2-year period for the Company and correlated with the components of the peer group. The stock price projection for the Company and the components of the peer group assumes a 0% dividend yield. This is mathematically equivalent to reinvesting dividends in the issuing entity over the performance period. The risk-free interest rate is based on the yield on the U.S. Treasury Strips as of the Measurement Date with a maturity consistent with the 2-year term associated with the market condition of the award. The fair value of this award of $1.3 million is being expensed on a straight-line basis over the grant date to the vesting date of December 31, 2022.

 

20

 

On February 24, 2022, the Company granted 240,428 shares of market-based stock to its executives in the form of restricted stock. The shares granted contain a market condition based on TSR. The TSR market condition measures the Company’s performance against a peer group. The market-based restricted stock awards will vest as to between 0% and 200% of the number of restricted shares granted to each recipient based on our total shareholder return during the period beginning on January 1, 2022 through December 31, 2023 as compared to the total shareholder return of 20 of our peers. The fair value of this award was determined using a Monte Carlo simulation with the following assumptions: a historical volatility of 63%, 0% dividend yield and a risk-free interest rate of 1.5%. The historical volatility was based on the most recent 2-year period for the Company and correlated with the components of the peer group. The stock price projection for the Company and the components of the peer group assumes a 0% dividend yield. This is mathematically equivalent to reinvesting dividends in the issuing entity over the performance period. The risk-free interest rate is based on the yield on the U.S. Treasury Strips as of the Measurement Date with a maturity consistent with the 2-year term associated with the market condition of the award. The fair value of this award of $6.7 million is being expensed on a straight-line basis over the grant date to the vesting date of December 31, 2023.

 

We recognized stock compensation expense of $605,000 and $285,000 related to market-based restricted stock awards for the three months ended March 31, 2022 and 2021. As of March 31, 2022, there was $7.0 million in unrecognized non-cash compensation costs related to market-based restricted stock awards expected to vest. We expect to recognize those costs over 1.6 years.

 

The aggregate fair value of the market-based awards granted during the three months ended March 31, 2022 and 2021 was $6.7 million and $1.6 million, respectively. The aggregate fair value of the market-based awards that vested during the three months ended March 31, 2022 and 2021 was $5.0 million and $10.2 million, respectively.

 

Total stock compensation expense

 

We recorded total stock compensation expense for the three months ended March 31, 2022 and 2021, as follows:

 

  

Three Months Ended

March 31,

 
  

2022

  

2021

 

Research and development costs

 $677  $183 

Sales and marketing costs

  705   184 

General and administrative costs

  3,010   979 

Cost of revenue

  1,007   159 

Total

 $5,399  $1,505 

 

 

 

9. Warrants

 

In March 2014, pursuant to a to a registered public offering and note conversion agreement with certain note holders, the Company issued warrants to purchase 6,910,283 shares of common stock at $4.75 per share. The warrants had an original expiration date of March 2021.

 

In May 2016, in connection with a credit facility, the Company issued a warrant to purchase 550,000 shares of common stock at $1.75 per share. The warrant was immediately exercisable and had an original expiration date of May 2021.

 

In May 2020, the Company entered into separate warrant exercise agreements with WAVI Holding AG and Taurus4757 GmbH pursuant to which the warrant holders immediately exercised their respective warrants via a “cashless” exercise as agreed to by the Company. As a result of the cashless exercise, the Company issued an aggregate of 2,747,970 shares of Company common stock upon cashless exercise of an aggregate of 3,871,405 warrants.

 

In March 2021, all remaining outstanding warrants were exercised via a “cashless” exercise. As a result of the cashless exercise, the Company issued an aggregate of 70,030 shares of Company common stock upon cashless exercise of an aggregate of 79,100 warrants.

 

The following table summarizes warrant activity for the three months ended March 31, 2022 and 2021:

 

  

Three Months Ended March 31,

 
  

2022

  

2021

 
  Shares  

Wtd. Avg.

Exercise Price

  Shares  

Wtd. Avg.

Exercise Price

 

Beginning balance

  0  $0   79,100  $4.75 

Exercised

  0   0   (79,100)  4.75 

Ending balance

  0  $0   0  $0 

 

21

 

 

10. Income taxes

 

The Company accounts for income taxes under ASC Topic 740 – Income Taxes. Under this standard, deferred tax assets and liabilities are recognized for future tax benefits or consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

 

The Company’s tax provision for interim periods is determined using an estimate of the annual effective income tax rate, adjusted for discrete items, if any, that occur in the relevant period. The income tax benefit of $599,000 for the three months ended March 31, 2022 resulted in an effective income tax rate of 8%. Included in the $599,000 were discrete tax benefits of $470,000 related to stock compensation windfall tax benefits offset by an increase in the valuation allowance.

 

The Company’s US projected effective income tax rate without discrete items was 5%, which is lower than the US federal statutory rate of 21% primarily due to the impact of a projected partial valuation allowance on net operating loss carryforwards and non-deductible executive compensation offset by state tax benefits and research tax credits.

 

Realization of deferred tax assets is dependent upon the generation of future taxable income, the timing and amount of which are uncertain. In determining the need for a valuation allowance, the Company’s management evaluates both positive and negative evidence when concluding whether it is more likely than not that deferred tax assets are realizable. After reviewing the evidence available, the Company’s management believes there is uncertainty regarding the future realizability of the U.S. net operating loss carryforward and is projecting a partial valuation allowance of $6.7 million by year end. If operating results improve and projections indicate future utilization of the tax attributes, all or a portion of the valuation allowance would be released, resulting in a corresponding non-cash income tax benefit.

 

 

11. Net (loss) income per common share

 

The Company considers its unexercised warrants and unvested restricted shares, which contain non-forfeitable rights to dividends, participating securities, and includes such participating securities in its computation of earnings per share pursuant to the two-class method. Basic earnings per share for the two classes of stock (common stock and warrants) is calculated by dividing net loss by the weighted average number of shares of common stock and warrants outstanding during the reporting period. Diluted earnings per share is calculated using the weighted average number of shares of common stock plus the potentially dilutive effect of common equivalent shares outstanding determined under both the two-class method and the treasury stock method, whichever is more dilutive. In periods when we have a net loss, common stock equivalents are excluded from our calculation of earnings per share as their inclusion would have an antidilutive effect.

 

The following table presents computations of basic and diluted earnings per share under the two-class method:

 

  

Three Months Ended

 
  

March 31,

 

(In thousands, except share and earnings per share data)

 

2022

  

2021

 

Numerator:

        

Net loss

 $(7,066) $(1,118)

Less: Preferred stock dividends and accumulated deficit impact of preferred stock redemption

  -   - 

Basic net loss attributable to common stockholders

  (7,066)  (1,118)
         

Denominator:

        

Basic and diluted weighted averge shares outstanding

  42,014,055   33,236,818 
         

Basic and diluted earnings per share attributable to common stockholders

 $(0.17) $(0.03)

 

22

 

The following table sets forth the number of weighted-average common shares excluded from the computation of diluted loss per share, as their inclusion would have been anti-dilutive: 

 

  

Three Months Ended

March 31,

 
  

2022

  

2021

 

Stock options and restricted stock awards

  2,094,863   2,134,884 

Warrants

  0   73,827 

Total

  2,094,863   2,208,711 

 

 

 

12. Commitments and contingencies

 

Employment agreements

 

We have employment agreements with certain key employees. None of these employment agreements is for a definitive period, but rather each will continue indefinitely until terminated in accordance with its terms. The agreements provide for a base annual salary, payable in monthly (or shorter) installments. Under certain conditions and for certain of these officers, we may be required to pay additional amounts upon terminating the employee or upon the employee resigning for good reason.

 

Litigation

 

From time to time, the Company is subject to various legal proceedings that arise in the ordinary course of business, none of which are currently material to the Company’s business. The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property. As a result, the Company may be subject to various legal proceedings from time to time. The results of any future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. Management is not aware of any significant pending or threatened litigation.

 

Indemnification

 

As permitted under Delaware law and in accordance with the Company’s bylaws, the Company is required to indemnify its officers and directors for certain errors and occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its directors. The Company believes the fair value of the indemnification rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of March 31, 2022.

 

 

 

13. Revenue

 

To determine revenue recognition for contractual arrangements that we determine are within the scope of Financial Accounting Standards Board (“FASB”) Topic 606, Revenue from Contracts with Customers, we perform the following five steps: (i) identify each contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to our performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the relevant performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Contracts with customers may contain multiple performance obligations. For such arrangements, the transaction price is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price, taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. Payment terms and conditions vary, although terms generally include a requirement of payment within 30 to 90 days. During the three months ended March 31, 2022, the Company recognized approximately $74,000 of revenue that was included in the deferred revenue balance at the beginning of the year.

 

The Company primarily recognizes product revenues, service revenues, and rental revenues. Product revenues are generated from the sale of cell processing tools, freezers, thawing devices, and cold chain products. We recognize product revenue, including shipping and handling charges billed to customers, at a point in time when we transfer control of our products to our customers, which is upon shipment for substantially all transactions. Shipping and handling costs are classified as part of cost of product revenue in the Consolidated Statement of Operations. Service revenues are generated from the storage of biological and pharmaceutical materials. We recognize service revenues over time as services are performed or ratably over the contract term. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the expected value method or the most likely amount method, depending on the facts and circumstances relative to the contract. When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of and during the three months ended March 31, 2022.

 

23

 

The Company also generates revenue from the leasing of our property, plant, and equipment, operating right-of-use assets, and evo cold chain systems within its storage and cold chain services product line to customers pursuant to service contracts or rental arrangements entered into with the customer. Revenue from these arrangements is not within the scope of FASB ASC Topic 606 as it is within the scope of FASB ASC Topic 842, Leases. All customers leasing shippers currently do so under month-to-month rental arrangements. We account for these rental transactions as operating leases and record rental revenue on a straight-line basis over the rental term.

 

The Company enters into various customer service agreements (collectively, “Service Contracts”) with customers to provide biological and pharmaceutical storage services. In certain of these Service Contracts, the property, plant, and equipment or operating right-of-use assets used to store the customer product are used only for the benefit of one customer. This is primarily driven by the customer’s desire to ensure that sufficient storage capacity is available in a specific geographic location for a set period of time. These agreements may include extension and termination clauses. These Service Contracts do not allow for customers to purchase the underlying assets.

 

The Company has assessed its Service Contracts and concluded that certain of the contracts for the storage of customer products met the criteria to be considered a leasing arrangement (“Embedded Leases”), with the Company as the lessor. The specific Service Contracts that met the criteria were those that provided a single customer with the ability to substantially direct the use of the Company’s property, plant, and equipment or operating right-of-use assets.

 

Under ASC 842, consistent with the previous guidance, the Company will continue to recognize operating right-of-use asset embedded lessor arrangements on its Unaudited Condensed Consolidated Balance Sheets in operating right-of-use assets.

 

None of the Embedded Leases identified by the Company qualify as a sales-type or direct finance lease. None of the operating leases for which the Company is the lessor include options for the lessee to purchase the underlying asset at the end of the lease term or residual value guarantees, nor are any such operating leases with related parties.

 

Embedded Leases may contain both lease and non-lease components. We have elected to utilize the practical expedient to account for lease and non-lease components together as a single combined lease component as the timing and pattern of transfer are the same for the non-lease components and associated lease component and, the lease component, if accounted for separately, would be classified as an operating lease. Non-lease components of the Company’s rental arrangements include reimbursements of lessor costs.

 

Total bioproduction tools and services revenue for the three months ended March 31, 2022 and 2021 were comprised of the following:

 

  

Three Months Ended

March 31,

 

(In thousands, except percentages)

 

2022

  

2021

 

Product revenue

        

Freezer and thaw

 $15,335  $4,848 

Cell processing

  14,899   8,928 

Storage and cold chain services

  154   0 

Service revenue

        

Storage and cold chain services

  3,090   2,204 

Rental revenue

        

Storage and cold chain services

  2,742   867 

Total revenue

 $36,220  $16,847 

 

24

 

The following table includes estimated rental revenue expected to be recognized in the future related to embedded leases as well as estimated service revenue expected to be recognized in the future related to performance obligations that are unsatisfied or partially unsatisfied as of the end of the reporting periods. The Company is electing not to disclose the value of the remaining unsatisfied performance obligation with a duration of one year or less as permitted by the practical expedient in ASU 2014-09, Revenue from Contracts with Customers. The estimated revenue in the following table does not include contracts with the original durations of one year or less, amounts of variable consideration attributable to royalties, or contract renewals that are unexercised as of March 31, 2022.

 

The balances in the table below are partially based on judgments involved in estimating future orders from customers subject to the exercise of material rights pursuant to respective contracts:

 

  

Year Ending December 31,

 

(In thousands)

 

2022 (9 months remaining)

  

2023

  

2024

  

Total

 

Rental revenue

 $7,068  $3,735  $900  $11,703 

Service revenue

 $79  $116  $10  $205 

 

 

 

14. Leases

 

We have various operating lease agreements for office space, warehouses, manufacturing, and production locations as well as vehicles and other equipment. Our real estate leases have remaining lease terms of one to ten years. We exclude options that are not reasonably certain to be exercised from our lease terms, ranging from one to five years. Our lease payments consist primarily of fixed rental payments for the right to use the underlying leased assets over the lease terms. For certain leases, we receive incentives from our landlords, such as rent abatements, which effectively reduce the total lease payments owed for these leases. Vehicle and other equipment operating leases have terms between one and five years.

 

Our financing leases relate to research equipment, machinery, and other equipment. 

 

The table below presents certain information related to the weighted average discount rate and weighted average remaining lease term for the Company’s leases as of March 31, 2022 and December 31, 2021:

 

  

March 31,

  

December 31,

 

(In thousands)

 

2022

  

2021

 

Weighted average discount rate - operating leases

  3.8

%

  3.8

%

Weighted average discount rate - finance leases

  6.1

%

  6.1

%

Weighted average remaining lease term in years - operating leases

  7.6   7.8 

Weighted average remaining lease term in years - finance leases

  2.7   3.0 

 

The components of lease expense for the three months ended March 31, 2022 and 2021 were as follows:

 

  

Three Months Ended

March 31,

 

(In thousands)

 

2022

  

2021

 

Operating lease costs

 $913  $460 

Short-term lease costs

  565   137 

Total operating lease costs

  1,478   597 
         

Variable lease costs

  305   128 

Total lease costs

 $1,783  $725 

 

Maturities of our lease liabilities as of March 31, 2022 are as follows: 

 

(In thousands)

 

Operating

Leases

  

Financing

Leases

 

2022 (9 months remaining)

 $2,626  $129 

2023

  3,230   171 

2024

  2,950   101 

2025

  2,485   37 

2026

  2,005   2 

Thereafter

  8,363   0 

Total lease payments

  21,659   440 

Less: interest

  (2,947)  (36)

Total present value of lease liabilities

 $18,712  $404 

 

25

 

 

15. Unaudited Condensed Consolidated Balance Sheet detail

 

Property and equipment

 

(In thousands)

 

March 31,

2022

  

December 31,

2021

 

Property and equipment

        

Leasehold improvements

 $3,949  $3,840 

Furniture and computer equipment

  1,819   1,861 

Manufacturing and other equipment

  16,807   16,675 

Construction in-progress

  2,818   2,022 

Subtotal

  25,393   24,398 

Less: Accumulated depreciation

  (7,134)  (6,741)

Net property and equipment

 $18,259  $17,657 

 

Depreciation expense for property and equipment was $757,000 and $575,000 for the three months ended March 31, 2022 and 2021, respectively.

 

Accrued expenses and other current liabilities

 

Accrued expenses and other current liabilities consist of the following:

 

(In thousands)

 

March 31,

2022

  

December 31,

2021

 

Accrued compensation

 $4,535  $4,351 

Accrued expenses

  1,372   1,656 

Deferred revenue, current

  895   814 

Accrued taxes

  33   27 

Other

  131   294 

Total accrued expenses and other current liabilities

 $6,966  $7,142 

 

Warranty reserve liability

 

We reserve estimated exposures on known claims, as well as anticipated claims, for product warranty and rework cost, based on historical product liability claims. Claim costs are deducted from the accrual when paid. Factors that could have an impact on the warranty accrual in any given period include the following: changes in manufacturing quality, changes in product costs, changes in product mix and any significant changes in sales volume.

 

A rollforward of our warranty liability is as follows:

 

  

Three Months Ended

March 31,

 

(In thousands)

 

2022

  

2021

 

Beginning balance

 $9,398  $212 

Provision for warranties

  894   11 

Settlements of warranty claims

  (1,116)  (22)

Ending Balance

 $9,176  $201 

 

 

 

16. Employee benefit plan

 

The Company sponsors 401(k) defined contribution plans for its employees. These plans provide for pre-tax and post-tax contributions for all employees. Employee contributions are voluntary. Employees may contribute up to 100% of their annual compensation to these plans, as limited by an annual maximum amount as determined by the Internal Revenue Service. The Company matches employee contributions in amounts to be determined at the Company’s sole discretion. The Company made $226,000 and $135,000 in contributions to the plan for the three months ended March 31, 2022 and 2021, respectively.

 

26

 

 

17. Subsequent events

 

The Company has evaluated events subsequent to March 31, 2022 through the date of this filing to assess the need for potential recognition or disclosure. Based upon this evaluation, it was determined that no subsequent events occurred that require recognition or disclosure in the Consolidated Financial Statements.

 

27

 

 

Item 2. Managements discussion and analysis of financial condition and results of operations

 

Forward looking statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements involve a number of risks and uncertainties. We caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement. These statements are based on current expectations of future events. Such statements include, but are not limited to, statements about our products, including our newly acquired products, customers, regulatory approvals, the potential utility of and market for our products and services, our ability to implement our business strategy and anticipated business and operations, in particular following our 2021, 2020, and 2019 acquisitions, future financial and operational performance, our anticipated future growth strategy, including the acquisition of synergistic cell and gene therapy manufacturing tools and services or technologies or other companies or technologies, capital requirements, intellectual property, suppliers, joint venture partners, future financial and operating results, the impact of the COVID-19 pandemic, plans, objectives, expectations and intentions, revenues, costs and expenses, interest rates, outcome of contingencies, financial condition, results of operations, liquidity, business strategies, regulatory filings and requirements, the estimated potential size of markets, capital requirements, the terms of any capital financing agreements, cost savings, objectives of management and other statements that are not historical facts. You can find many of these statements by looking for words like “believes”, “expects”, “anticipates”, “estimates”, “may”, “should”, “will”, “could”, “plan”, “intend”, or similar expressions in this Quarterly Report on Form 10-Q. We intend that such forward-looking statements be subject to the safe harbors created thereby.

 

These forward-looking statements are based on the current beliefs and expectations of our management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results may differ materially from current expectations and projections. These risks and uncertainties include those factors described in greater detail in the risk factors disclosed in our Form 10-K as of and for the fiscal year ended December 31, 2021 filed with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those anticipated in these forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q or, in the case of documents referred to or incorporated by reference, the date of those documents.

 

All subsequent written or oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We do not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events, except as may be required under applicable U.S. securities law. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

 

Overview

 

Management’s discussion and analysis provides additional insight into the Company and is provided as a supplement to, and should be read in conjunction with, our Annual Report on Form 10-K as of and for the fiscal year ended December 31, 2021 filed with the SEC.

 

We are a life sciences company that develops, manufactures, and markets bioproduction tools and services to the cell and gene therapy (“CGT”) industry and broader biopharma market, which are designed to improve quality and de-risk biologic manufacturing, storage, distribution, and transportation. Our products are used in basic and applied research and commercial manufacturing of biologic-based therapies. Customers use our products to maintain the health and function of biologic material during sourcing, manufacturing, storage, and distribution.

 

Our current portfolio of bioproduction tools and services are comprised of three revenue lines that contain seven main offerings: (i) cell processing (including biopreservation media for the preservation of cells and tissues, human platelet lysate media for the supplementation of cell expansion, cryogenic vials and automated fill machines that provide high-quality, efficient, and precise mixes of solutions), (ii) freezers and thaw systems (including a full line of mechanical ultra-low temperature (“ULT”), isothermal, and liquid nitrogen freezers and accessories, automated thaw devices which provide controlled, consistent thawing of frozen biologics in vials and cryobags), and (iii) storage and cold chain services (including biological and pharmaceutical storage services, and “smart”, cloud connected devices for transporting biologic payloads).

 

 

We currently operate as one bioproduction tools and services business which supports several steps in the biologic material manufacturing and delivery process. We have a diversified portfolio of tools and services that focus on biopreservation, cell processing, frozen biologic storage products and services, cold-chain transportation, and thawing of biologic materials. We have in-house expertise in cryobiology and continue to capitalize on opportunities to maximize the value of our product platform for our extensive customer base through both organic growth innovations and acquisitions.

 

Our products

 

Our bioproduction tools and services are comprised of three revenue lines that contain seven main offerings:

 

 Cell processing
  Biopreservation media
  Human platelet lysate media (“hPL”), cryogenic vials, and automated cell-processing fill machines
 Freezers and thaw systems
  Ultra-low temperature freezers
  Cryogenic freezers and accessories
  Automated thawing devices
 Storage and cold chain services
  Biological and pharmaceutical material storage
  Cloud connected “smart” shipping containers

 

Biopreservation media

 

Our proprietary biopreservation media products, HypoThermosol® FRS and CryoStor®, are formulated to mitigate preservation-induced, delayed-onset cell damage and death, which result when cells and tissues are subjected to reduced temperatures. Our technology can provide our CGT customers with significant shelf-life extension of biologic source material and final cell products, and can also greatly improve post-preservation cell and tissue viability and function. Our biopreservation media is serum-free, protein-free, fully defined, and manufactured under current Good Manufacturing Practices (cGMP). We strive to source wherever possible, the highest available grade, multi-compendium raw materials. We estimate our media products have been incorporated in over 530 customer clinical applications, including numerous chimeric antigen receptor (CAR) T cell and other cell types.

 

Stability (i.e. shelf-life) and functional recovery are crucial aspects of academic research and clinical practice in the biopreservation of biologic-based source material, intermediate derivatives, and isolated/derived/expanded cellular products and therapies. Limited stability is especially critical in the CGT field, where harvested cells and tissues will lose viability over time, if not maintained appropriately at normothermic body temperature (37ºC) or stored in a hypothermic state in an effective preservation medium. Chilling (hypothermia) is used to reduce metabolism and delay degradation of harvested cells and tissues. However, subjecting biologic material to hypothermic environments induces damaging molecular stress and structural changes. Although cooling successfully reduces metabolism (i.e., lowers demand for energy), various levels of cellular damage and death occur when using suboptimal methods. Traditional biopreservation media range from simple “balanced salt” (electrolyte) formulations to complex mixtures of electrolytes, energy substrates such as sugars, osmotic buffering agents and antibiotics. The limited stability, which results from the use of these traditional biopreservation media formulations, is a significant shortcoming that our optimized proprietary products address with great success.

 

Our scientific research activities over the last 20+ years enabled a detailed understanding of the molecular basis for the hypothermic and cryogenic (low-temperature induced) damage/destruction of cells through apoptosis and necrosis. This research led directly to the development of our HypoThermosol® FRS and CryoStor® technologies. Our proprietary biopreservation media products are specifically formulated to: 

 

 

Minimize cell and tissue swelling

 

Reduce free radical levels upon formation

 

Maintain appropriate low temperature ionic balances

 

Provide regenerative, high energy substrates to stimulate recovery upon warming

 

Avoid the creation of an acidic state (acidosis)

 

Inhibit the onset of apoptosis and necrosis

 

A key feature of our biopreservation media products is their “fully-defined” profile. All of our cGMP products are serum-free, protein-free and are formulated and filled using aseptic processing. We strive to use USP/Multicompendial grade or the highest quality available synthetic components. All of these features benefit prospective customers by facilitating the qualification process required to incorporate our products into their regulatory filings.

 

 

The results of independent testing demonstrate that our biopreservation media products significantly extend shelf-life and improve cell and tissue post-thaw viability and function. Our products have demonstrated improved biopreservation outcomes, including greatly extended shelf-life and post-thaw viability, across a broad array of cell and tissue types.

 

Competing biopreservation media products are often formulated with simple isotonic media cocktails, animal serum, potentially a single sugar or human protein. A key differentiator of our proprietary HypoThermosol FRS formulation is the engineered optimization of the key ionic component concentrations for low temperature environments, as opposed to normothermic body temperature around 37°C, as found in culture media or saline-based isotonic formulas. Competing cryopreservation freeze media is often comprised of a single permeating cryoprotectant such as dimethyl sulfoxide (“DMSO”). Our CryoStor formulations incorporate multiple permeating and non-permeating cryoprotectant agents which allow for multiple mechanisms of protection and reduces the dependence on a single cryoprotectant. We believe that our products offer significant advantages over in-house formulations, or commercial “generic” preservation media, including, time saving, improved quality of components, more rigorous quality control release testing, more cost effective and improved preservation efficacy.

 

We estimate that annual revenue from each customer commercial application in which our products are used could range from $500,000 to $2.0 million, if such application is approved and our customer commences large scale commercial manufacturing of the biologic based therapy.

 

Human platelet lysate media, cryogenic vials and automated cell-processing fill machines

 

In September 2021, we acquired Sexton Biotechnologies, Inc., a producer of bioproduction tools. Sexton's bioproduction tools portfolio includes hPL for cell expansion reducing risk and improving downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal® closed system vials that are purpose-built rigid containers used in CGT that can be filled manually or with high throughput systems, and automated cell processing machines bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination.

 

Compressor-free ULT freezers

 

In May 2021, we acquired Global Cooling, Inc. (“Global Cooling”), a manufacturer of class defining ultra-low temperature freezers. Global Cooling carries a portfolio of freezers that range in size from portable units to stationary upright freezers to accommodate a wide variety of use cases. Users can configure these freezers to achieve temperatures between -20°C and -86°C. The portfolio was designed to be environmentally friendly and energy efficient, using as little as 2.8 kWh/day at temperatures of -80°C. The freezers do not use compressor-based or cascade refrigeration systems. Instead, they use patented free-piston Stirling engine technology that uses fewer moving parts, resulting in maintenance cost savings for end users.

 

Liquid nitrogen freezers and storage devices

 

In November 2019, we acquired Custom Biogenic Systems, Inc. (“CBS”) a global leader in the design and manufacture of state-of-the-art liquid nitrogen laboratory freezers, cryogenic equipment and accessories.

 

Included in CBS’s product line of liquid nitrogen freezers are controlled-rate freezers and Isothermal LN2 freezers, constructed with a patented system which stores liquid nitrogen in a jacketed space in the walls of the freezer. This dry storage method eliminates liquid nitrogen contact with stored specimens, reduces the risk of cross-contamination and provides increased user safety in a laboratory setting. To accommodate customer requirements, we offer customizable features including wide bodied and extended height.

 

To accompany the offerings of cryogenic freezer equipment, we supply equipment for storing critically important biological materials. This storage equipment includes upright freezer racks, chest freezer racks, liquid nitrogen freezer racks, canisters/cassettes and frames as well as laboratory boxes and dividers. Due to our onsite design and manufacturing capability, racks and canisters can be customized to address customers’ varying requirements.

 

In order to provide customers with a proactive approach to safety and monitoring of equipment containing liquefied gas, CBS offers Versalert, a patented wireless remote asset monitoring system that can monitor and record temperatures. Versalert has an intelligent mesh network system that enables customers to view current equipment conditions and receive alarm notification on smartphones, tablets or personal computers and maintain permanent electronic records for regulatory compliance and legal verification.

 

Automated, water-free thawing products

 

In April 2019, we acquired Astero Bio Corporation (“Astero”). The Astero ThawSTAR® line includes automated vial and cryobag thawing products that control the heat and timing of the thawing process of biologic material. Our customizable, automated, water-free thawing products uses algorithmic programmed, heating plates to consistently bring biologic material from a frozen state to a liquid state in a controlled and consistent manner. This helps reduce cell structure damage during the temperature transition. The ThawSTAR® products can reduce risks of contamination versus using a traditional water bath.

 

 

Biological and pharmaceutical storage

 

In October 2020, we acquired SciSafe Holdings, Inc. (“SciSafe”), a premier provider of biological and pharmaceutical storage. In addition to providing storage services, SciSafe provides cold chain logistics that ensures materials are kept at target temperatures from the moment that the materials leave the customer’s premises to their ultimate return. State-of-the-art monitoring systems employed by SciSafe allow for customers to monitor the storage temperatures of their materials throughout the entire logistics chain.

 

We operate six storage facilities in the USA and one facility in the Netherlands.

 

evo® cloud connected shipping containers

 

In August 2019, we acquired the remaining shares of SAVSU Technologies, Inc. (“SAVSU”) we did not previously own. SAVSU is a leading developer and supplier of next generation cold chain management tools for cell and gene therapies. The evo.is cloud app allows biologic products to be traced and tracked in real time. Our evo platform consists of rentable cloud-connected shippers and include technologies that enable tracking software provides real-time information on geolocation, payload temperature, ambient temperature, tilt of shipper, humidity, altitude, and real-time alerts when a shipper has been opened. Our internally developed evo.is software allows customers to customize alert notifications both in data measurements and user requirements. The evo Dry Vapor Shipper (“DVS”) is specifically marketed to cell and gene therapies. The evo DVS has improved form factor and ergonomics over the traditional dewar, including extended thermal performance, reduced liquid nitrogen recharge time, improved payload extractors and ability to maintain temperature for longer periods on its side.

 

We utilize couriers who already have established logistic channels and distribution centers. Our strategy greatly reduces the cash need to build out specialized facilities around the world. Our partnerships with several white glove couriers allow us to scale our sales and marketing effort by utilizing their salesforce. Our courier partnerships market our evo platform to their existing cell and gene therapy customers as a cost effective and innovative solution. We also market directly to our existing and prospective customers who can utilize the evo platform through our courier partnerships.

 

Critical accounting policies and estimates

 

A “critical accounting policy” is one which is both important to the portrayal of our financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a description of our critical accounting policies that affect our more significant judgments and estimates used in the preparation of our Unaudited Condensed Consolidated Financial Statements, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations and our significant accounting policies in Note 1 to the Unaudited Condensed Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC.

 

Results of operations

 

The following discussion of the financial condition and results of operations should be read in conjunction with the accompanying Unaudited Condensed Consolidated Financial Statements and the related footnotes thereto.

 

Revenues

 

Total bioproduction tools and services revenue for three months ended March 31, 2022 and 2021 was comprised of the following:

 

  

Three Months Ended

March 31,

         

(In thousands, except percentages)

 

2022

  

2021

  

$ Change

  

% Change

 

Product revenue

                

Freezer and thaw

 $15,335  $4,848  $10,487   216

%

Cell processing

  14,899   8,928   5,971   67

%

Storage and cold chain services

  154   -   154   -

 

Service revenue

                

Storage and cold chain services

  3,090   2,204   886   40

%

Rental revenue

                

Storage and cold chain services

  2,742   867   1,875   216

%

Total revenue

 $36,220  $16,847  $19,373   115

%

 

 

Product revenue

 

Product revenue was $30.4 million for the three months ended March 31, 2022, representing an increase of $16.6 million, or 121%, compared with the same period in 2021. Organic revenue grew 45% due to the continued adoption of our cell processing products by customers in the CGT market and the expansion of our storage and cold chain services in the northeastern United States and the Netherlands.

 

Product revenue from our freezer and thaw products increased by $10.5 million, or 216%, in the three months ended March 31, 2022 compared with the same period in 2021. Organic freezer and thaw revenue decreased by 3% due to production delays that arose from supply chain disruptions.

 

Product revenue from our cell processing products increased by $6.0 million, or 67%, in the three months ended March 31, 2022 compared with the same period in 2021. Organic cell processing revenue increased 53%, as our cell processing products continue to be adopted by customers in the CGT market.

 

Product revenue from our storage and cold chain services was $154,000 in the three months ended March 31, 2022. The entirety of the $154,000 recognized was generated organically. Storage and cold chain services did not generate any product revenue in the three months ended March 31, 2021.

 

Service revenue

 

Service revenue was $3.1 million for the three months ended March 31, 2022, representing an increase of $886,000, or 40%, compared with the same period in 2021. The entirety of this increase was generated organically. The increase relates primarily to $903,000 of revenue generated by our Netherlands biorepository storage expansion which became operational in the fourth quarter of 2021.

 

Rental revenue

 

Rental revenue was $2.7 million for the three months ended March 31, 2022, representing an increase of $1.9 million, or 216%, compared with 2021. The entirety of this increase was generated organically. Increases in rental revenues are attributable to increased rental volumes to existing customers and the leasing of dedicated storage spaces and other assets through our biological and pharmaceutical services product line.

 

Costs and operating expenses

 

Total costs and operating expenses for three months ended March 31, 2022 and 2021 were comprised of the following:

 

  

Three Months Ended

March 31,

         

(In thousands, except percentages)

 

2022

  

2021

  

$ Change

  

% Change

 

Cost of product, rental, and service revenue

 $24,446  $7,550  $16,896   224

%

Research and development

  3,781   1,987   1,794   90

%

Sales and marketing

  4,891   2,021   2,870   142

%

General and administrative

  11,196   4,830   6,366   132

%

Intangible asset amortization

  2,863   933   1,930   207

%

Acquisition costs

  11   998   (987)  (99

)%

Change in fair value of contingent consideration

  (3,335)  (491)  (2,844)  579

%

Total operating expenses

 $43,853  $17,828  $26,025   146

%

 

Cost of product, rental, and service revenue

 

Cost of revenue increased $16.9 million, or 224%, respectively, compared to the same period in 2021, due primarily to the acquisitions of Global Cooling and Sexton. In addition to the acquisitions, the Company experienced higher than expected warranty expense and material costs. We expect that cost of product revenue may fluctuate in future quarters based on production volumes, raw material and transportation costs, customer mix, and product mix.

 

Cost of revenue net of intangible amortization related to acquired technology was 71% and 48% for the three months ended March 31, 2022 and 2021, respectively. The increase in cost of revenue net of intangible amortization related to acquired technology is a result of increased revenues from lower margin product lines acquired in 2021.

 

Research and development expenses

 

Research and development (“R&D”) expense consist primarily of salaries and other personnel-related costs, non-cash stock-based expense, consulting, and external product development services.

 

 

R&D expense for the three months ended March 31, 2022 increased $1.8 million, or 90%, respectively, compared with the same period in 2021. The increase is primarily due to our acquisitions of Global Cooling in Q2 2021 and Sexton in Q3 2021.

 

We expect our R&D expense to increase as we continue to expand, develop, and refine the product lines we acquired in 2019, 2020, and 2021.

 

Sales and marketing expenses

 

Sales and marketing expense (“S&M”) consists primarily of salaries and other personnel-related costs, non-cash stock-based expense, consulting, trade shows, travel, sales commissions, and advertising.

 

S&M expense for the three months ended March 31, 2022 increased $2.9 million, or 142%, respectively, compared with the same period in 2021. The increase is primarily due to our acquisitions of Global Cooling in Q2 2021 and Sexton in Q3 2021, increased non-cash stock-based expense and increased expenses related to travel and tradeshows.

 

We expect S&M expense to increase, as we expand our direct selling efforts to support the broader product line offerings resulting from our acquisitions in 2019, 2020, and 2021.

 

General and administrative expenses

 

General and administrative (“G&A”) expense consists primarily of personnel-related costs, non-cash stock-based expense for administrative personnel and members of the board of directors, professional fees, such as accounting and legal, and corporate insurance.

 

G&A expenses for the three months ended March 31, 2022 increased $6.4 million, or 132%, respectively, compared with the same period in 2021. The increase reflects the assumption of G&A expenses related to our acquisitions of Global Cooling in Q2 2021 Sexton in Q3 2021, increased headcount and non-cash stock-based compensation expense, accounting fees, and insurance expense.

 

We expect G&A expense to increase reflecting the infrastructure and costs related to supporting the larger expected enterprise created as a result of our growth strategy.

 

Intangible asset amortization expense

 

Amortization expense consists of charges related to the amortization of intangible assets associated with the acquisitions of Astero, SAVSU, CBS, SciSafe, Global Cooling, and Sexton in which we acquired definite-lived intangible assets.

 

Acquisition costs

 

Acquisition costs consist of legal, accounting, third-party valuations, and other due diligence costs incurred related to our SciSafe, Global Cooling, and Sexton acquisitions.

 

Change in fair value of contingent consideration

 

Change in fair value of contingent consideration consists of changes in estimated fair value of our potential earnouts related to our Astero, CBS, and SciSafe acquisitions.

 

Other income and expense

 

Total other income and expenses for the three months ended March 31, 2022 and 2021 were comprised of the following:

 

  

Three Months Ended

March 31,

         

(In thousands, except percentages)

 

2022

  

2021

  

$ Change

  

% Change

 

Change in fair value of warrant liability

 $-  $(121) $121   (100

)%

Interest expense, net

  (163)  (16)  (147)  919

%

Other expense

  131   -   131   -

%

Total other income, net

 $(32) $(137) $105   (77

)%

 

 

Change in fair value of warrant liability. Reflects the changes in fair value associated with the periodic “mark to market” valuation of certain warrants that were issued in 2014. All outstanding warrants were exercised via a “cashless” exercise on March 25, 2021.

 

Interest income (expense), net. We earn interest on cash held in our money market account. Interest expense in the three months ended March 31, 2022 grew compared to 2021 due to debt acquired in the acquisition of Global Cooling and equipment financing.

 

Liquidity and capital resources

 

On March 31, 2022 and December 31, 2021, we had $59.5 million and $69.9 million in cash and cash equivalents, respectively. Based on our current expectations with respect to our future revenue and expenses, we believe that our current level of cash and cash equivalents will be sufficient to meet our liquidity needs for at least the next twelve months from the date of the filing of this Form 10-Q. However, the Company may choose to raise additional capital through a debt or equity financing in order to pursue additional acquisition or strategic investment opportunities. Additional capital, if required, may not be available on reasonable terms, if at all.

 

Cash flows

 

  

Three Months Ended

March 31,

     

(In thousands)

 

2022

  

2021

  

$ Change

 

Operating activities

 $(7,924) $1,820  $(9,744)

Investing activities

  (2,270)  (4,427)  2,157 

Financing activities

  (181)  1,216   (1,397)

Net (decrease) increase in cash and cash equivalents

 $(10,375) $(1,391) $(8,984)

 

Net cash (used in) provided by operating activities

 

During the three months ended March 31, 2022, net cash used by operating activities was $7.9 million compared to net cash provided by operating activities of $1.8 million for the three months ended March 31, 2021. The increase in cash used by operating activities was primarily the result of the timing of collection and disbursement of working capital related items in accounts receivable, inventory, accounts payable, and accrued expenses and other current liabilities.

 

Net cash used in investing activities

 

Net cash used by investing activities totaled $2.3 million during the three months ended March 31, 2022 compared to net cash used by investing activities of $4.4 million for the three months ended March 31, 2021. The decrease in cash used by investing activities was the result of significant investments made in Q1 2021 to support the expansion of our storage and cold chain services product line that did not recur in Q1 2022.

 

Net cash (used in) provided by financing activities

 

Net cash used by financing activities totaled $181,000 during the three months ended March 31, 2022, compared to net cash provided by financing activities of $1.2 million during the three months ended March 31, 2021. The differences noted in cash used or provided by investing activities was the result of equipment loans entered into in Q1 2021.

 

Off-balance sheet arrangements

 

As of March 31, 2022, we did not have any off-balance sheet arrangements. 

 

Contractual obligations

 

We previously disclosed certain contractual obligations and contingencies and commitments relevant to us within the financial statements and Management Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC. There have been no significant changes to these obligations in the three months ended March 31, 2022.

 

Item 3. Quantitative and qualitative disclosures about market risk

 

Not applicable.

 

 

Item 4. Controls and procedures

 

Evaluation of Disclosure Controls and Procedures. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Form 10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this Form 10-Q were not effective, due to the material weaknesses in our internal controls over financial reporting. As previously reported, we identified material weaknesses in our internal controls over financial reporting as of December 31, 2021 with regard to (i) inappropriately designed entity-level controls impacting the control environment, risk assessment, and monitoring activities to prevent or detect material misstatements to the consolidated financial statements attributed to an insufficient number of qualified resources and inadequate oversight and accountability over the performance of controls, ineffective identification and assessment or risks impacting internal control over financial reporting, and ineffective monitoring controls; (ii) information system logical access within certain key financial systems; (iii) accounting policies and procedures and related controls over complex financial statement areas; (iv) accounting policies, procedures, and related controls over assets held for lease; (v) accounting policies, procedures, and related controls over the preparation and review of projected financial information used in determining the valuation of acquired intangible assets and contingent consideration in business combinations as well as the quantitative impairment analysis of indefinite-lived intangible assets; and (vi) policies, procedures, and related controls over the presentation and disclosure of amounts presented in the consolidated financial statements in accordance with the applicable financial reporting requirements.

 

Changes in Internal Control Over Financial Reporting. Other than the remediation of a previously identified material weakness as described below, there was no change in our internal control over financial reporting that occurred during the quarter ended March 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on Effectiveness of Control. Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within BioLife Solutions have been detected.

 

Remediation.

 

With respect to the material weakness related to information system logical access within certain key financial systems described above, management has continued to test and evaluate the elements of the remediation plan implemented to date, which consisted of removing administrator access rights from accounting personnel. Based on management’s review and the oversight of the Audit Committee, we have determined that this weakness was fully remediated as of March 31, 2022.

 

With respect to the other material weaknesses described above, management plans to implement the following measures:

 

 

The Company plans to hire and retain additional individuals with the appropriate skills related to technical accounting and internal control over financial reporting;

 

 

The Company will enhance its reconciliations and management review controls with the added stability of new hires and the implementation of technology solutions to automate visibility and enforcement of the independent review and documentation of journal entries, including proper segregation of duties, thus mitigating risks of both unintentional errors and fraud; and

 

 

The Company plans to develop processes and procedures to enhance the precision of management review of financial statement information.

 

As we continue to evaluate and test the remediation plan outlined above, we may also identify additional measures to address the material weaknesses or modify certain of the remediation procedures described above. We also may implement additional changes to our internal control over financial reporting as may be appropriate in the course of remediating the material weaknesses. Management, with the oversight of the Audit Committee, will continue to take steps necessary to remedy the material weaknesses to reinforce the overall design and capability of our control environment.

 

 

PART II: Other information

 

Item 1. LEGAL PROCEEDINGS

 

From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.

 

 

Item 1A. RISK FACTORS

 

The matters discussed in this Quarterly Report on Form 10-Q include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which BioLife has little or no control. A number of important risks and uncertainties, including those identified under the caption “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the period ended December 31, 2021 and in subsequent filings, could cause our actual results to differ materially from those in the forward-looking statements. There are no material changes to the risk factors described in our Annual Report on Form 10-K for the period ended December 31, 2021.

 

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

Item 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

Item 4. MINE SAFETY DISCLOSURES

 

None.

 

Item 5. OTHER INFORMATION

 

None.

 

 

Item 6. Exhibits

 

Exhibit No.

 

Description

   

31.1

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

   

31.2

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

   

32.1

 

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

   

32.2

 

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

   

101.INS

 

XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

   

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

   

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

   

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

   

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

   

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

   

104

 

Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

BIOLIFE SOLUTIONS, INC.

  
  

Date: May 10, 2022

/s/ Troy Wichterman

 

Troy Wichterman

 

Chief Financial Officer

 

(Duly authorized officer and principal

 

financial and accounting officer) 

 

 

BIOLIFE SOLUTIONS, INC.

 

INDEX TO EXHIBITS

 

Exhibit No.

 

Description

   

31.1

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

   

31.2

 

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

   

32.1

 

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

   

32.2

 

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

   

101.INS

 

XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

   

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

   

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

   

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

   

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

   

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

   

104

 

Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

 

39