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, 20182019

 

☐    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)

 

 

 

———————

 

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 registrant’s principal executive offices, Zip Code)

 

(425) 402-1400

(Telephone number, including area code)

 

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 and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted 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 and post said files). Yes  ☑   No  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or 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  ☑

 

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

As of May 8, 2018, 15,104,7431, 2019, 18,799,386 shares of the registrant’s common stock were outstanding.

 

1

Table of Contents

 

BIOLIFE SOLUTIONS, INC.

 

FORM 10-Q

 

FOR THE QUARTER ENDED MARCH 31, 20182019

 

TABLE OF CONTENTS

 

PART I.  FINANCIAL INFORMATION

3

 

 

 

Item 1.

Financial Statements

3

 

 

 

 

Balance Sheets as of March 31, 20182019 (unaudited) and December 31, 20172018

3

 

 

 

 

Statements of Operations (unaudited) for the three month periods ended March 31, 20182019 and 20172018

4

Statements of Shareholders’ Equity (unaudited) for the three month periods ended March 31, 2019 and 20185

 

 

 

Statements of Cash Flows (unaudited) for the three month periods ended March 31, 20182019 and 20172018

5

6

 

 

 

Notes to Financial Statements (unaudited)

6

7

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

12

13

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

16

17

 

 

Item 4.

Controls and Procedures

16

17

 

 

PART II.

OTHER INFORMATION

16

17

 

 

Item 6.

Exhibits

16

17

 

 

 

Signatures

17

18

 

 

 

Index to Exhibits

18

19

 

2

Table of Contents

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioLife Solutions, Inc.

Balance Sheets

 

 

March 31,

  

December 31,

  

March 31,

  

December 31,

 
 

2018

  

2017

 

(In thousands, except per share and share data)

 

2019

(unaudited)

  

2018

 

Assets

                

Current assets

                

Cash and cash equivalents

 $7,032,513  $6,663,318  $31,824  $30,657 

Accounts receivable, trade, net of allowance for doubtful accounts of $5,575 at March 31, 2018 and December 31, 2017

  1,043,815   1,021,315 

Accounts receivable, trade, net of allowance for doubtful accounts of $0 at March 31, 2019 and December 31, 2018

  2,927   3,045 

Inventories

  1,836,666   1,846,746   4,060   3,509 

Prepaid expenses and other current assets

  330,904   399,502   346   353 

Total current assets

  10,243,898   9,930,881   39,157   37,564 
                

Property and equipment

                

Leasehold improvements

  1,284,491   1,284,491   1,284   1,284 

Furniture and computer equipment

  692,270   682,466   704   706 

Manufacturing and other equipment

  1,194,659   1,148,006   1,803  ��1,657 

Subtotal

  3,171,420   3,114,963   3,791   3,647 

Less: Accumulated depreciation

  (2,084,769

)

  (2,008,927

)

  (2,424

)

  (2,328

)

Net property and equipment

  1,086,651   1,106,036   1,367   1,319 

Operating lease right-of-use assets

  1,196    

Investment in SAVSU

  926,364   1,070,120   6,317   6,548 

Long-term deposits

  36,166   36,166   36   36 

Total assets

 $12,293,079  $12,143,203  $48,073  $45,467 
                

Liabilities and Shareholders’ Equity

                

Current liabilities

                

Accounts payable

 $586,334  $690,702  $1,264  $720 

Accrued expenses and other current liabilities

  202,779   200,548   142   91 

Accrued compensation

  392,248   491,432   630   998 

Lease liability - operating, current portion

  651    
Lease liability – financing, current portion  14    

Deferred rent, current portion

  130,216   130,216      130 

Total current liabilities

  1,311,577   1,512,898   2,701   1,939 

Deferred rent, long-term

  457,518   492,207      349 

Long-term lease liability - operating

  980    

Long-term lease liability - financing

  13    

Other long-term liabilities

  52,520   45,512   13   31 

Total liabilities

  1,821,615   2,050,617   3,707   2,319 
                

Commitments and Contingencies (Note 8)

                
                

Shareholders’ equity

                

Preferred stock, $0.001 par value; 1,000,000 shares authorized, Series A, 4,250 shares designated, and 4,250 shares issued and outstanding at March 31, 2018 and December 31, 2017

  4   4 

Common stock, $0.001 par value; 150,000,000 shares authorized, 14,145,413 and 14,021,422 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively

  14,145   14,021 

Common stock, $0.001 par value; 150,000,000 shares authorized, 18,717,095 and 18,547,406 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively

  19   19 

Additional paid-in capital

  84,517,966   84,036,444   114,951   114,160 

Accumulated deficit

  (74,060,651

)

  (73,957,883

)

  (70,604

)

  (71,031

)

Total shareholders’ equity

  10,471,464   10,092,586   44,366   43,148 

Total liabilities and shareholders’ equity

 $12,293,079  $12,143,203  $48,073  $45,467 

  

The accompanying Notes to Financial Statements are an integral part of these financial statements

 

3

Table of Contents

 

BIOLIFE SOLUTIONS, INC.

BioLife Solutions, Inc.

Statements of Operations

(unaudited)

 

 

Three Month Period Ended March 31,

  

Three Month Period Ended March 31,

 
 

2018

  

2017

 

(In thousands, except per share and share data)

 

2019

  

2018

 

Product revenue

 $3,814,882  $2,366,201  $5,770  $3,815 

Cost of product sales

  1,363,829   928,402   1,647   1,364 

Gross profit

  2,451,053   1,437,799   4,123   2,451 

Operating expenses

                

Research and development

  346,454   286,751   372   346 

Sales and marketing

  611,502   511,944   848   612 

General and administrative

  1,353,377   1,103,143   2,204   1,353 

Acquisition costs

  208    

Total operating expenses

  2,311,333   1,901,838   3,632   2,311 
                

Operating income (loss)

  139,720   (464,039

)

Operating income

  491   140 
                

Other income (expense), net

                

Interest Income

  8,418   48 

Interest Expense

  (900

)

  (83,333

)

Amortization of debt discount

 

 

   (93,598

)

Interest income

  171   8 

Interest expense

  (3

)

  (1

)

Loss from equity-method investment in SAVSU

  (143,756

)

  (229,368

)

  (232

)

  (144

)

Total other income (expenses), net

  (136,238

)

  (406,251

)

  (64

)

  (137

)

                

Net income (loss)

  3,482   (870,290

)

Net income

  427   3 

Less: Preferred stock dividends

  (106,250

)

 

 

      (106

)

Net loss attributable to common stockholders

 $(102,768

)

 $(870,290

)

Net income (loss) attributable to common stockholders

 $427  $(103

)

                

Basic and diluted net loss per common share

 $(0.01

)

 $(0.07

)

Basic net income (loss) per common share

 $0.02  $(0.01

)

Diluted net income (loss) per common share

 $0.02  $(0.01

)

                

Basic and diluted weighted average common shares used to calculate net loss per common share

  14,098,610   12,964,639 

Weighted average shares outstanding used to compute basic earnings per share

  18,648,397   14,098,610 

Weighted average shares outstanding used to compute diluted earnings per share

  24,358,475   14,098,610 

 

The accompanying Notes to Financial Statements are an integral part of these financial statements

 

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BIOLIFE SOLUTIONS, INC.

BioLife Solutions, Inc.

Statements of Cash FlowsShareholders’ Equity

(unaudited)

 

  

Three Month Period Ended
March 31,

 
  

2018

  

2017

 

Cash flows from operating activities

        

Net income (loss)

 $3,482  $(870,290

)

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

        

Depreciation

  77,823   89,549 

Stock-based compensation expense

  373,425   329,895 

Amortization of deferred rent related to lease incentives

  (31,749

)

  (31,750

)

Amortization of debt discount

     93,598 

Loss from equity-method investment in SAVSU

  143,756   229,368 
         

Change in operating assets and liabilities

        

(Increase) Decrease in

        

Accounts receivable, trade

  (22,500

)

  132,873 

Inventories

  10,080   (54,388

)

Prepaid expenses and other current assets

  11,598   (138,029

)

Increase (Decrease) in

        

Accounts payable

  (68,743

)

  (11,970

)

Accrued compensation and other current liabilities

  (102,643

)

  41,447 

Accrued interest, related party

     83,333 

Deferred rent

  (2,940

)

  (62,984

)

Net cash provided by (used in) operating activities

  391,589   (169,348

)

         

Cash flows from investing activities

        

Purchase of property and equipment

  (40,834

)

  (37,152

)

Net cash used in investing activities

  (40,834

)

  (37,152

)

         

Cash flows from financing activities

        

Proceeds from note payable

     1,000,000 

Payments on equipment loan

  (1,635

)

    

Payments on capital lease obligation

  (3,271

)

    

Proceeds from exercise of common stock options and warrants

  129,596   120,000 

Payments of preferred stock dividends

  (106,250

)

   

Deferred costs related to security issuance

     (29,400

)

Net cash provided by financing activities

  18,440   1,090,600 
         

Net increase in cash and cash equivalents

  369,195   884,100 
         

Cash and cash equivalents - beginning of period

  6,663,318   1,405,826 
         

Cash and cash equivalents - end of period

 $7,032,513  $2,289,926 
         

Non-cash financing activity

        

Stock issued for services provided in prior period included in liabilities at year-end

 $35,625  $35,624 

Purchase of equipment with debt

 $17,604    

Series A preferred stock dividends accrued not yet paid

 $106,250    

Deferred costs related to security issuance not yet paid as of quarter end

    $7,856 

(In thousands, except share data)

 

Preferred
Stock
Shares –
Series A

 

 

Preferred
Stock
Amount –
Series A

 

 

Common
Stock
Shares

 

 

Common
Stock
Amount

 

 

Additional
Paid-in
Capital

 

 

Accumulated
Deficit

 

 

Total
Shareholders’
Equity

 

Balance, December 31, 2017

 

 

4,250 

 

 

$

–– 

 

 

 

14,021,422

 

 

$

14

 

 

$

84,036

 

 

$

(73,958

)

 

$

10,092

 

Stock based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

373

 

 

 

 

 

 

 

373

 

Stock option/warrant exercises

 

 

 

 

 

 

 

 

 

 

62,438

 

 

 

––

 

 

 

73

 

 

 

 

 

 

 

73

 

Stock issued – on vested RSUs

 

 

 

 

 

 

 

 

 

 

55,614

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

––

 

Stock issued for services

 

 

 

 

 

 

 

 

 

 

5,939

 

 

 

––

 

 

 

36

 

 

 

 

 

 

 

36

 

Preferred stock dividends

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(106

)

 

 

(106

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

3

 

Balance, March 31, 2018

 

 

4,250

 

 

$

–– 

 

 

 

14,145,413

 

 

$

14

 

 

$

84,518

 

 

$

(74,061

)

 

$

10,471

 

                             

Balance, December 31, 2018

 

 

––

 

 

 

–– 

 

 

 

18,547,406

 

 

19

 

 

114,160

 

 

$

(71,031

)

 

43,148

 

Stock based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 ––

 

 

 

606

 

 

 

 

 

 

 

606

 

Stock option/warrant exercises

 

 

 

 

 

 

 

 

 

 

104,697

 

 

 

––

 

 

 

185

 

 

 

 

 

 

 

185

 

Stock issued – on vested RSUs

 

 

 

 

 

 

 

 

 

 

64,992

 

 

 

––

 

 

 

––

 

 

 

 

 

 

 

––

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

427

 

 

 

427

 

Balance, March 31, 2019

 

 

––

 

 

–– 

 

 

 

18,717,095

 

 

$

19

 

 

$

114,951

 

 

$

(70,604

)

 

$

44,366

 

 

The accompanying Notes to Financial Statements are an integral part of these financial statements

 

5

Table of Contents

 

BIOLIFE SOLUTIONS, INC.

BioLife Solutions, Inc.

Statements of Cash Flows

(unaudited)

  

Three Month Period Ended
March 31,

 

(In thousands)

 

2019

  

2018

 

Cash flows from operating activities

        

Net income

 $427  $3 

Adjustments to reconcile net income to net cash provided by operating activities

        

Depreciation

  98   78 

Stock-based compensation expense

  606   373 

Amortization of operating lease liability

  (43

)

   

Interest expense – finance type lease

  2    

Amortization of deferred rent related to lease incentives

     (32

)

Loss from equity-method investment in SAVSU

  232   144 
         

Change in operating assets and liabilities

        

(Increase) Decrease in

        

Accounts receivable, trade

  118   (23

)

Inventories

  (551

)

  10 

Prepaid expenses and other current assets

  6   12 

Increase (Decrease) in

        

Accounts payable

  553   (69

)

Accrued compensation and other current liabilities

  (302

)

  (101

)

Deferred rent

     (3

)

Net cash provided by operating activities

  1,146   392 
         

Cash flows from investing activities

        

Purchase of property and equipment

  (156

)

  (41

)

Net cash used in investing activities

  (156

)

  (41

)

         

Cash flows from financing activities

        

Payments on equipment loan

  (4

)

  (3

)

Payments on capital lease obligation/finance lease

  (4

)

  (3

)

Proceeds from exercise of common stock options and warrants

  185   73 

Cash received in advance of issuance of stock on warrant exercises

     57 

Payments of preferred stock dividends

     (106

)

Net cash provided by financing activities

  177   18 
         

Net increase in cash and cash equivalents

  1,167   369 
         

Cash and cash equivalents - beginning of period

  30,657   6,663 
         

Cash and cash equivalents - end of period

 $31,824  $7,032 
         

Non-cash investing and financing activities

        

Stock issued for services provided in prior period included in liabilities at year-end

 $  $36 

Purchase of equipment with debt

 $  $18 

Series A preferred stock dividends accrued not yet paid

 $  $106 

Purchase of property & equipment not yet paid

 $46  $ 

The accompanying Notes to Financial Statements are an integral part of these financial statements

6

Table of Contents

BioLife Solutions, Inc.

Notes to Financial Statements

(unaudited)

 

 

1. Organization and Significant Accounting Policies

 

Business

 

BioLife Solutions, Inc. (“BioLife,” “us,” “we,” “our,” or the “Company”) is a leading developer, manufacturer and marketersupplier of proprietary clinical grade cellbiopreservation media and tissueautomated thawing devices for cells and gene therapies. Our CryoStor® freeze media and HypoThermosol® hypothermic storage and cryopreservation freeze media. Our proprietary HypoThermosol® and CryoStor® platform of solutionsshipping media are highly valued in the regenerative medicine, biobanking and drug discovery and regenerative medicine markets. OurThese novel biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. Our enabling technology providesdeath; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and functionfunction. Our recently acquired ThawSTAR™ product line is comprised of cells, tissues,a family of automated thawing devices for frozen cell and organs. Additionally,gene therapies packaged in cryovials and cryobags. These products improve the quality of administration of high-value, temperature-sensitive biologic therapies to patients by standardizing the thawing process and reducing the risks of contamination and overheating, which are inherent with the use of traditional water baths. See Note 11 for our direct, distributor, and contract customers, we perform custom formulation, fill, and finish services. more information.

 

Basis of Presentation

 

We have prepared the accompanying unaudited financial statements pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Pursuant to these rules and regulations, we have condensed or omitted certain information and footnote disclosures we normally include in our annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). In management’s opinion, we have made all adjustments (consisting only of normal, recurring adjustments) necessary to fairly present our financial position, results of operations and cash flows. Our interim period operating results do not necessarily indicate the results that may be expected for any other interim period or for the full year. These financial statements and accompanying notes should be read in conjunction with the financial statements and notes thereto in our Annual Report on Form 10-K10-K for the year ended December 31, 2017 2018 on file with the SEC.

 

There have been no material changes to our significant accounting policies except as described below as compared to the significant accounting policies described in the financial statements in our Annual Report on Form 10-K10-K for the year ended December 31, 2017, except the adoption of Accounting Standards Update (ASU) No.2014-09, Revenue from Contracts with Customers (Topic 606).2018.

 

Significant Accounting Policies Update

 

Revenue Recognition

On January 1, 2018, we adoptedIn February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) (“ASU”) No.2014-09, Revenue from Contracts 2016-02, Leases: Topic 842 (“ASU 2016-02”) that replaces existing lease guidance. The new standard is intended to provide enhanced transparency and comparability by requiring lessees to record right-of-use assets and corresponding lease liabilities on the balance sheet. Under the new guidance, leases will continue to be classified as either finance or operating, with Customers (Topic 606)classification affecting the pattern of expense recognition in the Statements of Operations. Lessor accounting is largely unchanged under ASU 2016-02.

We adopted ASU 2016-02 and related ASUs (collectively ASC 842) effective January 1, 2019 using the additional transition option for the modified retrospective approach applied to those contracts in effect as of method and did not restate comparative periods. Consequently, periods before January 1, 2018. Under this transition method, results for reporting periods beginning after January 1, 2018 are presented under the new standard, while prior period amounts are not adjusted and2019 will continue to be reported in accordance with the prior accounting guidance, ASC 840, Leases. We elected the package of practical expedients, which permits us to retain prior conclusions about lease identification, lease classification and initial direct costs for leases that commenced before January 1, 2019. The new standard also provides practical expedients for an entity’s ongoing accounting. We elected the short-term lease recognition exemption for all leases that qualify. We also elected the practical expedient to combine lease and non-lease components for all of our historical accounting under Topic 605, Revenue Recognition.leases other than net lease real estate leases.

The adoption of this standard resulted in the recording of operating lease right-of-use assets of $1.3 million and short-term and long-term lease liabilities of $1.8 million as of January 1, 2019. The difference between right-of-use assets and lease liabilities relates to liabilities of $0.5 million for deferred rent and lease incentives liabilities that were included on our Balance Sheet prior to adoption of ASC 842. These amounts were eliminated at the time of adoption and are included in the lease liabilities. Adoption of the new standardASC 842 did not have ana material impact on the amounts reported in our financial statementsCompany’s net earnings and there were had no other significant changes impacting the timing or measurement of our revenue or our business processes and controls. impact on cash flows.

 

To determine revenue recognition for contractual arrangements that we determine are within the scope of Topic 606, 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. Our revenues are primarily generated from the sale of our biopreservation media products. We generally recognize product revenue, including shipping and handling charges billed to customers, when we transfer control of our products to our customers as our contracts have a single performance obligation (transfer of control generally occurs upon shipment of our product). We are not required to disclose the value of unsatisfied performance obligations as our contracts have a duration of one year or less.

We invoice and receive payment from our customers after we recognize revenue, resulting in receivables from our customers that are presented as accounts receivable on our balance sheet. Accounts receivable consist of short-term amounts due from our customers (generally 30 to 90 days) and are stated at the amount we expect to collect. We establish an allowance for doubtful accounts based on our assessment of the collectability of specific customer accounts. Changes in accounts receivable are primarily due to the timing and magnitude of orders of our products, the timing of when control of our products is transferred to our customers and the timing of cash collections.

Equity Method Investments

 

We account for our ownership in our biologistex CCM, LLC joint ventureSAVSU Technologies, Inc. (“SAVSU”) using the equity method of accounting. This method states that if the investment provides us the ability to exercise significant influence, but not control, over the investee, we account for the investment under the equity method. Significant influence is generally deemed to exist if the Company’s ownership interest in the voting stock of the investee ranges between 20% and 50%, although other factors, such as representation on the investee’s board of directors, are considered in determining whether the equity method of accounting is appropriate. Under the equity method of accounting, the investment is recorded at its initial carrying value in the balance sheet and is periodically adjusted for capital contributions, dividends received and our share of the investee’s earnings or losses together with other-than-temporary impairments which are recorded as a component of other income (expense), net in the statements of operations. Our effective ownership in SAVSU was effectively reduced from 35% to 26.7% during44.4% at March 31, 2019 and December 31, 2018. For the three months ended March 31, 2018 due to additional cash contributions made by the majority owner, SAVSU Technologies LLC. For the three months ended March 31, 2018 2019 and 2017,2018, SAVSU’s net loss totaled $538,413$522,000 and $509,706, of which our ownership resulted in a $143,756 and $229,368 loss, respectively which was recorded as “Loss from equity-method investment in SAVSU.”$538,000, respectively.

 

6

Concentrations of credit risk and business risk

 

In the three months ended March 31, 2018, 2019, we derived approximately 30%34% of our product revenue from two customers. In the three months ended March 31, 2017, 2018, we derived approximately 21%30% of our product revenue from two customers. No other customer accounted for more than 10% of revenue in the three months ended March 31, 2018 2019 or 2017. At 2018. In the three months ended March 31, 2019 and 2018, we derived approximately 90% and 86%, of our revenue from CryoStor products, respectively. At March 31, 2019, two customers accounted for approximately 34%45% of total gross accounts receivable. At December 31, 2017, two2018, three customers accounted for approximately 41%71% of total gross accounts receivable. 

 

Revenue from customers located in Canada represented 23% and in all other foreign countries represented 13% and 22%17% of total revenue during the three months ended March 31, 2018 2019. Revenue from customers located in Canada represented 12% and 2017, respectively.in all other foreign countries represented 13% of total revenue during the three months ended March 31, 2018. All revenue from foreign customers are denominated in United States dollars. 

Recent Accounting Pronouncements

 

In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No.2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (ASU 2016-15). The updated guidance clarifies how companies present and classify certain cash receipts and cash payments in the statement of cash flows. We adopted the new standard on January 1, 2018, with no material impact on our financial statements.

In February 2016, the FASB issued Accounting Standards Update No.2016-02, Leases: Topic 842 (ASU 2016-02) that replaces existing lease guidance. The new standard is intended to provide enhanced transparency and comparability by requiring lessees to record right-of-use assets and corresponding lease liabilities on the balance sheet. Under the new guidance, leases will continue to be classified as either finance or operating, with classification affecting the pattern of expense recognition in the Statements of Operations. Lessor accounting is largely unchanged under ASU 2016-02. Adoption of ASU 2016-02 is required for fiscal reporting periods beginning after December 15, 2018, including interim reporting periods within those fiscal years with early adoption being permitted. The new standard is required to be applied with a modified retrospective approach to each prior reporting period presented with various optional practical expedients. While the Company expects adoption of ASU 2016-02 to lead to a material increase in the assets and liabilities recorded on its Balance Sheet, the Company is still evaluating the overall impact on its financial statements.

In January 2016, the FASB issued Accounting Standards Update No.2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities: Topic 825 (ASU 2016-01). The updated guidance enhances the reporting model for financial instruments, which includes amendments to address aspects of recognition, measurement, presentation and disclosure. We adopted the new standard on January 1, 2018, with no material impact on our financial statements.

With the exception of the new standards discussed above, thereThere have been no new accounting pronouncements not yet effective that have significance, or potential significance, to our Financial Statements.

 

7

Table of Contents

 

 

2. Fair Value Measurement  

 

In accordance with FASB ASCAccounting Standards Codification (“ASC”) Topic 820, “Fair Value Measurements and Disclosures,” (“ASC Topic 820”), the Company measures its cash and cash equivalents and short-term investments at fair value on a recurring basis. 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-tierthree-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.

 

As of March 31, 2018 2019 and December 31, 2017, 2018, the Company does not have liabilities that are measured at fair value.

 

The following tables set forth the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2018 2019 and December 31,2017, 2018, based on the three-tierthree-tier fair value hierarchy:

 

(In thousands)

As of March 31, 2018

 

Level 1

  

Level 2

  

Total

 

Bank deposits

 $6,979,336  $  $6,979,336 

Money market funds

  53,177      53,177 

Total Cash and cash equivalents

 $7,032,513  $  $7,032,513 

As of March 31, 2019

 

Level 1

  

Level 2

  

Total

 

Total cash and cash equivalents

 $31,824  $  $31,824 

 

 

As of December 31, 2017

 

Level 1

  

Level 2

  

Total

 

Bank deposits

 $6,610,183  $  $6,610,183 

Money market funds

  53,135      53,135 

Total Cash and cash equivalents

 $6,663,318  $  $6,663,318 

As of December 31, 2018

 

Level 1

  

Level 2

  

Total

 

Total cash and cash equivalents

 $30,657  $  $30,657 

 

The fair values of bank depositscash and money market fundscash equivalents classified as Level 1 were derived from quoted market prices as active markets for these instruments exist. The Company has no level 2 or level 3 financial assets. The Company did not have any transfers between Level 1 and Level 2 of the fair value hierarchy during the three months ended March 31, 2018 2019 and the twelve months ended December 31,2017. 2018.

 

 

3. Inventory  

 

Inventory consists of the following at March 31, 2018 2019 and December 31,2017: 2018:

 

 

March 31, 2018

  

December 31, 2017

 

(In thousands)

 

March 31, 2019

  

December 31, 2018

 

Raw materials

 $573,331  $582,816  $1,629  $1,453 

Work in progress

  517,027   453,890   949   652 

Finished goods

  746,308   810,040   1,482   1,404 

Total

 $1,836,666  $1,846,746  $4,060  $3,509 

 

8

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4. Deferred Rent  

 

Deferred rent consists of the following at March 31, 2018 and December 31, 2017:2018. We eliminated our deferred rent at January 1, 2019 as a result of the implementation of ASU 2016-02 (see Note 10):

 

  

March 31, 2018

  

December 31, 2017

 

Landlord-funded leasehold improvements

 $1,124,790  $1,124,790 

Less accumulated amortization

  (661,274

)

  (629,525

)

Total

  463,516   495,265 

Straight line rent adjustment

  124,218   127,158 

Total deferred rent

 $587,734  $622,423 

8

(In thousands)

 

December 31, 2018

 

Landlord-funded leasehold improvements

 $1,125 

Less accumulated amortization

  (757

)

Total

  368 

Straight line rent adjustment

  111 

Total deferred rent

 $479 

 

During the three month periods ended March 31, 2018 2019 and 2017,2018, the Company recorded $31,749none and $31,750,$32,000, respectively, in deferred rent amortization of these landlord funded leasehold improvements.

 

Straight line rent adjustment for the three months ended March 31, 2018 represents the difference between cash rent payments and the recognition of rent expense on a straight-line basis over the terms of the lease.

 

 

5. Share-based Compensation      

 

Service Vesting-BasedVesting-Based Stock Options

 

The following is a summary of service vesting based stock option activity for the three month period ended March 31, 2018, 2019, and the status of stock options outstanding at March 31, 2018:2019:

 

 

Three Month Period Ended

  

Three Month Period Ended

 
 

March 31, 2018

  

March 31, 2019

 
     

Wtd. Avg.

      

Weighted Avg.

 
     

Exercise

      

Exercise

 
 

Options

  

Price

  

Options

  

Price

 

Outstanding at beginning of year

  2,390,012  $1.85   2,043,402  $1.91 

Granted

    $N/A     $N/A 

Exercised

  (62,438

)

 $1.16   (99,697

)

 $1.61 

Forfeited

  (730

)

 $2.62   (3,438

)

 $5.69 

Expired

    $N/A     $N/A 

Outstanding at March 31, 2018

  2,326,844  $1.87 

Outstanding at March 31, 2019

  1,940,267  $1.92 
                

Stock options exercisable at March 31, 2018

  1,637,951  $1.76 

Stock options exercisable at March 31, 2019

  1,657,436  $1.89 

 

We recognized stock compensation expense of $152,703$144,000 and $170,323$153,000 related to service vesting-based options during the three month periods ending March 31, 2018 2019 and 2017,2018, respectively. As of March 31, 2018, 2019, there was $7,640,555$31.0 million of aggregate intrinsic value of outstanding service vesting-based stock options, including $5,551,232$26.5 million of aggregate intrinsic value of 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 quarter 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, 2018. 2019. This amount will change based on the fair market value of the Company’s stock. During the quarters ended March 31, 2018 2019 and 20172018 intrinsic value of service vesting-based awards exercised was $270,241$1.4 million and $70,714, respectively. Weighted average grant date fair value for service based-vesting options granted during the three months ended March 31, 2018 and March 31, 2017 was none and $1.13 per share,$270,000, respectively. The weighted average remaining contractual life of service vesting-based options outstanding and exercisable at March 31, 2018, 2019 is 6.1 years.5.4 years and 5.3 years, respectively. Total unrecognized compensation cost of service vesting-based stock options at March 31, 2018 2019 of $1,019,680$374,000 is expected to be recognized over a weighted average period of 2.01.4 years.

Performance-based Stock Options

 

The Company’s Board of Directors implemented a Management Performance Bonus Plan for 2017. Based on achieving varying levels of specified revenue for the year ending ended December 31, 2017, up to 1,000,000 options to purchase shares of the Company’s common stock may be vested. The options have an exercise price of $1.64,$1.64, and if revenue levels for 2017 were met, would vest 50% on the release of the Company’s audited financial statements for 2017, and 50%one year thereafter. If the minimum performance targets are were not achieved, no options would vest. On February 27, 2018, the Company’s Board of Directors determined that, subject to the completion of the 2017 audit, the specified revenue target had been achieved. Accordingly, 999,997 options to purchase shares of the Company’s common stock vestedvest as follows: 50% of the options vested on March 8, 2018 and the remaining 50% will vest vested on March 8, 2019.

 

We recognized stock compensation expense of $125,507none and $125,508$125,000 related to performance-based options during the three month periods ending March 31, 2018 2019 and 2017,2018, respectively. As of March 31, 2018, 2019, there was $3,489,990$15.7 million of aggregate intrinsic value of outstanding performance-based stock options, including $1,745,003 of aggregate intrinsic value ofand exercisable performance-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 quarter 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, 2018. 2019. This amount will change based on the fair market value of the Company’s stock. During the quarters ended March 31, 2018 2019 and 20172018 there were no performance-based awardsoptions exercised. The weighted average remaining contractual life of performance-based options outstanding and exercisable at March 31, 2018, 2019, is 3.72.7 years. TotalThere is no unrecognized compensation cost of performance-based stock options at March 31, 2018 2019. There were 964,997 performance-based stock options outstanding at the beginning and ending of $383,493 is expected to be recognized over a weighted averagethe three month period of 0.75 years.ending March 31, 2019.

 

The fair value ofThere were no stock options granted to employees and non-employee directors is estimated onin the measurement date using the Black-Scholes model using the following weighted average assumptions (N/A for 2018 as no options were granted in that period).three month periods ended March 31, 2019 and 2018.

Three Month Period Ended

March 31,

2018

2017

Risk free interest rate

N/A2.07

%

Dividend yield

N/A0.0

%

Expected term (in years)

N/A5.18

Volatility

N/A75

%

 

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Table of Contents

 

Restricted Stock

Service vesting-based restricted stock

 

The following is a summary of service vesting-based restricted stock activity for the three month period ended March 31, 2018, 2019, and the status of unvested service vesting-based restricted stock outstanding at March 31, 2018:2019:

 

 

Three Month Period Ended

  

Three Month Period Ended

 
 

March 31, 2018

  

March 31, 2019

 
 

Number of
Restricted
Shares

  

Grant-Date
Fair Value

  

Number of
Restricted
Shares

  

Grant-Date
Fair Value

 

Unvested outstanding at beginning of year

  237,926  $1.79   279,919  $5.00 

Granted

  161,768  $6.00   146,614  $17.84 

Vested

  (55,613

)

 $1.78   (64,992

)

 $4.47 

Forfeited

  (6,100

)

 $1.76   (8,418

)

 $6.66 

Unvested outstanding at March 31, 2018

  337,981  $3.80 

Unvested outstanding at March 31, 2019

  353,123  $10.39 

 

The aggregate fair value of the service vesting-based awards granted during the three months ended March 31, 2019 and 2018 was $2.6 million and 2017 was $970,608 and $364,936,$1.0 million, respectively, which represents the market value of BioLife common stock on the date that the restricted stock awards were granted. The aggregate fair value of the service vesting-based restricted stock awards that vested was $307,058$853,000 and $41,097$307,000 for the three months ended March 31, 2019 and March 31, 2018, and March 31, 2017, respectively.

 

We recognized stock compensation expense of $95,215$255,000 and $34,064$95,000 related to service vesting-based restricted stock awards for the three months ended March 31, 2019 and March 31, 2018, and March 31, 2017, respectively. As of March 31, 2018, 2019, there was $1,208,936$3.5 million in unrecognized compensation costs related to service vesting-based restricted stock awards. We expect to recognize those costs over 3.43.6 years.

Performance-based restricted stock

In 2019, we engaged an independent executive compensation firm, FW Cook, to review current compensation practices and make updated recommendations to the Compensation Committee and the full Board of Directors. With consideration to the recommendations of FW Cook, including an evaluation of the compensation practices of a like-situated peer group of public life science companies, our Compensation Committee recommended and our Board of Directors approved a compensation program which included apportioning a portion of management’s equity compensation to performance-based restricted stock awards. Specifically, our executive officers were granted service-based restricted stock awards (94,247 shares of restricted stock in the aggregate vesting over four years) and performance-based restricted stock awards (94,247 shares of restricted stock in the aggregate). The performance-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, 2019 through December 31, 2020 as compared to the total shareholder return of 20 of our peers (such peers having been determined by our Compensation Committee with assistance of FW Cook immediately prior to the grant date). The 94,247 performance-based restricted stock awards will be awarded if we are in the 50th percentile of total shareholder return versus the peer group. The maximum number of performance-based restricted stock awards that may be granted (188,494 shares in the aggregate) will be awarded if we are in the 80th percentile of total shareholder return versus the peer group and no units will be awarded for less than 30th percentile of total shareholder return versus the peer group.

During the three month period ended March 31, 2019, we assumed 94,247 performance-based restricted stock awards will be awarded with a grant-date fair value of $17.84. The aggregate fair value of the performance-based restricted stock awards was $1.7 million. We recognized stock compensation expense of $207,000 for the three months ended March 31, 2019. As of March 31, 2019, there was $1.5 million in unrecognized non-cash compensation costs related to performance-based restricted stock awards. We expect to recognize those costs over 1.8 years.

 

We recorded total stock compensation expense for the three month periods ended March 31, 2018 2019 and 2017,2018, as follows:

 

 

Three Month Period Ended

  

Three Month Period Ended

 
 

March 31,

  

March 31,

 
 

2018

  

2017

 

(In thousands)

 

2019

  

2018

 

Research and development costs

 $65,595  $59,265  $80  $65 

Sales and marketing costs

  68,513   59,619   166   69 

General and administrative costs

  190,949   168,198   328   191 

Cost of product sales

  48,368   42,813   32   48 

Total

 $373,425  $329,895  $606  $373 

  

 

6. Warrants  

 

At March 31, 2018 2019 and December 31, 2017, 2018, we had 6,676,8494,075,005 and 6,688,8494,080,005 warrants outstanding, respectively and exercisable with a weighted average exercise price of $4.50$4.35 at the end of each period. During the three month period ended March 31, 2018, 12,0002019, 5,000 warrants were exercised with a weighted average exercise price of $4.75,$4.75, yielding $57,000$24,000 in proceeds to the Company in which the stock was issued April 3, 2018. Subsequent to quarter end through May 8, 2018, an additional 920,116 warrants were exercised with a weighted average exercise priceCompany.

10

Table of $4.75, yielding $4.4 million in proceeds to the Company.

Contents

 

 

7. Net LossIncome (Loss) per Common Share          

 

Basic net lossearnings per common share is calculated by dividing the net lossincome (loss) attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share is calculated using the weighted average number of common shares outstanding plus dilutive common stock equivalents outstanding as determined by the treasury method during the period. CommonIn periods when we have a net loss, common stock equivalents are excluded forfrom our calculation of earnings per share as their inclusion would have an antidilutive effect. For the three month periodsperiod ended March 31, 2019, we excluded a nominal amount of unvested stock awards from our calculation of diluted weighted average shares because they were antidilutive. For the three month period ended March 31, 2018, and 2017, since the effect is anti-dilutive due to the Company’s net losses attributable towe excluded 3.3 million common stockholders. Common stock equivalents include stock options, 6.7 million warrants, and 338,000 unvested restricted stock.stock awards from our calculation of diluted weighted average shares because they were antidilutive.

The following table shows the calculation of basic and diluted earnings per shares:

 

  

Three Month Period Ended

 
  

March 31,

 

(In thousands, except per share and share data)

 

2019

  

2018

 

Numerator:

        

Net income (loss) attributable to common stockholders

 $427  $(103

)

         

Denominator:

        

Weighted average basic shares outstanding

  18,648,397   14,098,610 

Effect of dilutive securities

  5,710,078    

Weighted average diluted shares

  24,358,475   14,098,610 
         

Basic earnings per share

 $0.02  $(0.01

)

Diluted earnings per share

 $0.02  $(0.01

)

10
11

 

Basic weighted average common shares outstanding, and the potentially dilutive securities excluded from loss per share computations because they are anti-dilutive, are as follows as of March 31, 2018 and 2017, respectively:

  

Three Month Period Ended

March 31,

 
  

2018

  

2017

 

Basic and diluted weighted average common stock shares outstanding

  14,098,610   12,964,639 

Potentially dilutive securities excluded from loss per share computations:

        

Common stock options

  3,326,841   3,387,581 

Common stock purchase warrants

  6,676,849   7,603,141 

Restricted stock unvested

  337,981   282,350 

 

8. Commitments and Contingencies

 

Leases

We lease approximately 30,000 square feet in our Bothell, Washington headquarters. The term of our lease continues until July 31, 2021 with two options to extend the term of the lease, each of which is for an additional period of five years, with the first extension term commencing, if at all, on August 1, 2021, and the second extension term commencing, if at all, immediately following the expiration of the first extension term. In accordance with the amended lease agreement, our monthly base rent is approximately $58,000 at March 31, 2018, with scheduled annual increases each August and again in October for the most recent amendment. We are also required to pay an amount equal to the Company’s proportionate share of certain taxes and operating expenses.

Employment agreements

 

We have employment agreements with our Chief Executive Officer, Chief Financial Officer, Chief Technology Officer, Vice President of Operations, Vice President of Marketing, and Vice President of Sales. None of these employment agreements isare 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 officer or upon the officer 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.

 

 

9. Preferred Stock

As of March 31, 2018, we accrued a dividend of $106,250 on the preferred stock which is included in accrued expenses and other current liabilities in the balance sheet at March 31, 2018. The dividend was paid subsequent to quarter end on April 2, 2018. 

10.9. Revenue

 

We currently operate as one operating segment focusing on biopreservation media.tools.

 

The following table disaggregates revenue by market segment and distributors:

 

 

Three Months Ended

March 31,

  

Three Months Ended

March 31,

 
 

2018

  

2017

 

(In thousands)

 

2019

  

2018

 

Net product sales:

                

Regenerative medicine

 $2,103,552  $1,051,170  $2,179  $2,104 

Drug discovery

  376,975   277,914   238   377 

BioBanking

  295,112   277,429   249   295 

Distributors

  1,039,243   759,688   3,104   1,039 

Total revenues

  3,814,882   2,366,201  $5,770  $3,815 

 

 
11

10. Leases

Our operating leases are primarily related to our Bothell, Washington headquarters space lease. The term of our lease continues until July 31, 2021 with two options to extend the term of the lease, each of which is for an additional period of five years, with the first extension term commencing, if at all, on August 1, 2021, and the second extension term commencing, if at all, immediately following the expiration of the first extension term. We have not included these extension options in our ROU assets or lease liabilities as we are reasonably certain we will not enter into the renewal option in their current terms. Our financing lease is related to research equipment. We used a weighted average discount rate of 6.5%, our market collateralized borrowing rate, and 8.1%, the weighted average implied interest on our leases, to determine our operating and financing lease liabilties, respectively. The weighted average remaining term of our operating and financing leases are 2.3 years and 1.9 years, respectively. The operating lease costs and cash paid in the three months ended March 31, 2019 was $142,000 and $186,000, respectively.

Maturities of lease liabilities as of March 31, 2019

(In thousands)

 

Operating Leases

  

Financing Leases

 

2019 (less than one year)

 $548  $11 

2020

  764   15 

2021

  451   3 

Total lease payments

  1,763   29 

Less: interest

  (132)  (2)

Total present value of lease liabilities

 $1,631  $27 

11. Subsequent Event

On April 1, 2019, we closed the previously announced transaction for the acquisition of 100% of Astero Bio Corporation ("Astero"), an innovator in the design, development and commercialization of novel automated thawing devices for cell and gene therapies, for an upfront cash payment of $8 million. This transaction is expected to further strengthen BioLife's position as a leading supplier of disruptive, enabling solutions used in the manufacture, storage and distribution of cell and gene therapies. We believe Astero's ThawSTAR product line broadens BioLife's bioproduction tools portfolio and increases the Company's footprint and engagement level in its customers' cell and gene therapy manufacturing workflow. Under the terms of the share purchase agreement, Astero shareholders are eligible to receive up to an additional $4.5 million in cash based on the completion of certain product development milestones and an additional $8.0 million in cash over the next three years based on attainment of specific revenue targets.

We incurred $208,000 of related acquisition costs for the three month period ending March 31, 2019, which are reflected in our Statement of Operations. We expect to report Astero as a consolidated entity as of April 1, 2019. The acquisition qualifies as a business combination and will be accounted for using the acquisition method of accounting.

Due to the limited time since the acquisition date and the effort required to assess the fair value of assets acquired and liabilities assumed, the initial accounting for the business combination is incomplete at the time of this filing. As a result, the Company is unable to provide the amounts recognized for the major classes of assets acquired and liabilities assumed, acquisition contingencies and goodwill. Also, the Company is unable to provide pro forma revenues and earnings of the combined entity. This information is expected to be included in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.

12

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements”. 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 future financial and operating results, plans, objectives, expectations and intentions, costs and expenses, interest rates, outcome of contingencies, financial condition, results of operations, liquidity, business strategies, 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. Examples of these forward-looking statements include, but are not limited to:

 

anticipated product developments, regulatory filings and related requirements;

 

timing and amount of future contractual payments, product revenue and operating expenses;

 

market acceptance of our products and the estimated potential size of these markets; and

 

projections regarding liquidity, capital requirements and the terms of any financing agreements.

 

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 for the fiscal year ended December 31, 20172018 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 for the fiscal year ended December 31, 20172018 filed with the SEC.

 

We were incorporated in Delaware in 1987 under the name Trans Time Medical Products, Inc. In 2002, the Company, then known as Cryomedical Sciences, Inc., and engaged in manufacturing and marketing cryosurgical products, completed a merger with our wholly-owned subsidiary, BioLife Solutions, Inc., which was engaged as a developer and marketer of biopreservation media products for cells and tissues. Following the merger, we changed our name to BioLife Solutions, Inc.

 

Our proprietary clinical grade HypoThermosol® FRS and CryoStor® biopreservation media products are marketed to the regenerative medicine, biobanking and drug discovery markets, including hospital-based stem cell transplant centers, pharmaceutical companies, cord blood and adult stem cell banks, hair transplant centers, and suppliers of cells to the drug discovery, toxicology testing and diagnostic markets. All of our biopreservation media products are serum-free and protein-free, fully defined, and are manufactured under current Good Manufacturing Practices (cGMP) using United States Pharmacopia (USP)/Multicompendialand we strive to utilize USP/multicompendial grade or the highest quality available gradesynthetic components.

 

1213

 

Our patented biopreservation media products are formulated to reduce preservation-induced, delayed-onset cell damage and death. Our platform enabling technology provides our customers significant shelf life extension of biologic source material and final cell products, and also greatly improved post-preservation cell, tissue, and organ viability and function.

 

The discoveries made by our scientists and consultants relate to how cells, tissues, and organs respond to the stress of hypothermic storage, cryopreservation, and the thawing process. These discoveries enabled the formulation of innovative biopreservation media products that protect biologic material from preservation-related cellular injury, much of which is not apparent immediately after return to normothermic body temperature. Our product formulations have demonstrated notable reduction in apoptotic (programmed) and necrotic (pathologic) cell death mechanisms and are enabling the clinical and commercial development of dozens of innovative regenerative medicine products.

 

Additionally, as of March 31, 2018,2019, we owned a 26.7%44.4% interest in our joint venture, biologistex CCM, LLCSAVSU Technologies, Inc. (“SAVSU”), a Delaware limited liability company. Ourcorporation. We have an 18-month purchase option, entered into on September 4, 2018, which provides us, at our sole discretion, with the right to acquire the 56% ownership was effectively reduced from 35% to 26.7% during the three months ended March 31, 2018 due to additional cash contributions made byinterest of SAVSU Technologies LLC (“STLLC”). SAVSU isnot already owned, in the business of acquiring, developing, maintaining, owning, operating, marketing and selling an integrated platform of a cloud-based information service and precision thermal shipping products. The evo™ line is a line of “smart shippers” designedexchange for the shipmentgreater of 1,000,000 shares of our common stock, or approximately $23 million of our common stock, calculated on the day of exercise. SAVSU, a privately held company headquartered in Albuquerque, New Mexico, designs, manufactures and markets integrated, innovative hardware and software solutions designed to protect living biologic materials which must be maintained frozen, at 2-8˚C and/or controlled room temperature temperaturesduring transport and where near real time monitoring of temperature, location,storage. SAVSU’s customers include cell and payload status information is necessary. A sophisticated electronics package embedded in the evo provides streaming data to the SAVSU web-based application; where real time shipment status, history,gene therapy companies, specialty couriers, and reports can be generated. Designed for small volume shipments; it fills a critical need in chain-of-custody scenarios for temperature sensitive shipments of cells, tissues, and other cell based products.research institutions.

 

Highlights for the First Quarter of 20192018

 

Biopreservation media products revenue was $3.8$5.8 million in the first quarter of 2018,2019, an increase of 61%51% over the same period in 2017.2018. First quarter revenue growth was primarily driven by a 100%200% year over year increase from customers in the regenerative medicine segment due to increased demand from late stage and commercial cell therapy customers and safety stock orders. Additionally, first quarter revenue from distributors increased 37% and revenue from drug discovery customers increased 36% over the same period in 2017. our distributors.

 

Gross margin in the first quarter of 20182019 was 64%71%, compared to 61%64% in the first quarter of 2017.2018. The margin increased due to higher average selling price per literprices and increased sales volume.

  

For the three months ended March 31, 2018,2019, operating income was $140,000. This$491,000, after incurring $208,000 cost from the Astero acquisition, compared to an operating loss of ($464,000)$140,000 in the first quarter of 2017. We were able to generate an operating2018. Operating profit increased due to the increase in sales and gross margin from the same period of the prior year.

 

For the three months ended March 31, 2018,2019, net income was $3,000. This$427,000 compared to a net loss of ($870,000)$3,000 in the first quarter of 2017. We were able to generate a net profit2018. Net income increased due to the increase in sales and gross margin from the same period of the prior year.

 

Gained 3625 new customers in the first quarter of 2018,2019, including first time orders from 19 regenerative medicine companies.

  

Announced thatExpected to benefit from new policies to advance the development of safe and effective cell and gene therapies as set forth in a statement issued by the U.S. PatentFood and Trademark Office has issued a notice of allowance of a patent application to our joint venture, SAVSU, titled "Biologic Stability, Delivery Logistics andDrug Administration of Time and/or Temperature Sensitive Biologic Based Materials".(FDA) on January 15, 2019.

 

Announced our joint venture SAVSU will supply SAVSU smart precision shipping containers throughoutEntered into an agreement to acquire Astero Bio Corporation ("Astero"), a privately-held innovator in the World Courier network. SAVSU designsdesign, development and manufactures innovative high-performance cloud-connected passivecommercialization of novel automated thawing devices, for an upfront cash payment of $8.0 million. This transaction, which closed on April 1, 2019, is expected to further strengthen BioLife's position as a leading supplier of disruptive, enabling solutions used in the manufacture, storage and transport containers optimized for thedistribution of cell and gene therapies. We believe Astero's ThawSTAR product line broadens our bioproduction tools portfolio and increases our footprint and engagement level in our customers' cell and gene therapy supply chain.

Executedmanufacturing workflow. Under the terms of the agreement, Astero shareholders are eligible to receive up to an OEM agreement to supply CryoStor cell freeze mediaadditional $4.5 million in cash based on the completion of certain product development milestones and HypoThermosol cell storage and shipping media under private label to MilliporeSigma,an additional $8.0 million in cash over the life science businessnext three years based on attainment of Merck KGaA, Darmstadt, Germany.

Cell freeze media highlighted in Mayo Clinic/MD Anderson Journal article on Preservation of Patient-Derived Xenografts for Cancer Research. In multiple comparisons of preservation efficacy of patient-derived xenograft (PDX) tumors, CryoStor was superior to a traditional DMSO-containing home-brew freeze media cocktail.

Our joint venture SAVSU was awarded a second patent for next generation cold chain technologies designed for cell and gene therapies.

specific revenue targets.

  

Results of Operations

Our revenue, results of operations and cash balances are likely to fluctuate significantly from quarter-to-quarter. These fluctuations are due to a number of factors, specifically the progress of our customers’ clinical trials, where the pace of enrollment affects customer orders for our products. The majority of our net sales come from a relatively small number of customers and a limited number of market sectors. Each of these sectors is subject to macroeconomic conditions as well as trends and conditions that are sector specific. Any weakness in the market sectors in which our customers are concentrated could affect our business and results of operations.

 

1314

 

Comparison of Results of Operations for the Three Month Periods Ended March 31, 20192018 and 20182017

 

Revenue and Gross Margin

 

 

Three Month Period Ended

      

Three Month Period Ended

     
 

March 31,

      

March 31,

     
 

2018

  

2017

  

% Change

  

2019

  

2018

  

% Change

 
            

(In thousands)

            

Total revenue

 $3,814,882  $2,366,201   61

%

 $5,770  $3,815   51

%

                        

Cost of sales

  1,363,829   928,402   47

%

  1,647   1,364   21

%

Gross profit

 $2,451,053  $1,437,799   70

%

 $4,123  $2,451   68

%

Gross margin %

  64

%

  61

%

      71

%

  64

%

    

 

 

Biopreservation Media Product Sales. Our corebiopreservation media products are sold through both direct and indirect channels to customers in the regenerative medicine, biobanking and drug discovery markets. Sales of our core proprietarybiopreservation products in the three months ended March 31, 20182019 increased 61%51% compared to the same period in 2017, due primarily to an increase in volume and selling price per liter sold2018, due to increased orders from the regenerative medicine segment. Revenue growth for the first quarter was driven by a 100% year over year increase from customers in the regenerative medicine segment due to increased demand from late stage cell therapy customers as well as a 37% increase in sales to our distributors. We expect to see continued growth in adoption and use of our proprietary biopreservation media products.

 

Cost of Sales. Cost of sales consists of raw materials, labor and overhead expenses. Cost of sales in the three months ended March 31, 20182019 increased compared to the same period in 20172018 due to increased sales of our biopreservation media products and write-off of raw materialsproduct mix, partially offset by lower overhead costs per liter sold in the three months ended March 31, 2018.2019.

 

Gross Margin. Gross margin as a percentage of revenue was 71% in the three months ended March 31, 2019 compared to 64% in the three months ended March 31, 2018 compared to 61% in the three months ended March 31, 2017.2018. The increase in margin is due to higher average selling price and lower overhead costs per liter sold.

 

Revenue Concentration. In the three months ended March 31, 2018,2019, we derived approximately 30%34% of our product revenue from two customers. In the three months ended March 31, 2017,2018, we derived approximately 21%30% of our product revenue from two customers. No other customer accounted for more than 10% of revenue in the three months ended March 31, 20182019 or 2017.2018.

 

Operating Expenses

Our operating expenses for the three month periods ended March 31, 20182019 and 20172018 were:

 

 

Three Month Period Ended

      

Three Month Period Ended

     
 

March 31,

      

March 31,

     
 

2018

  

2017

  

% Change

 

(In thousands)

 

2019

  

2018

  

% Change

 

Operating Expenses:

                        

Research and development

 $346,454  $286,751   21

%

 $372  $346   7

%

Sales and marketing

  611,502   511,944   19

%

  848   612   39

%

General and administrative

  1,353,377   1,103,143   23

%

  2,204   1,353   63

%

Acquisition costs

  208      100

%

Operating Expenses

 $2,311,333  $1,901,838   22

%

 $3,632  $2,311   57

%

% of revenue

  61

%

  80

%

      63

%

  61

%

    

 

Research and Development. Research and development expenses consist primarily of salaries and other personnel-related expenses, consulting and other outside services, laboratory supplies, and other costs. We expense all research and development costs as incurred. Research and development expenses for the three months ended March 31, 20182019 increased compared to the three months ended March 31, 2017,2018, due primarily to increased payroll expenses. 

 

Sales and Marketing. Sales and marketing expenses consist primarily of salaries and other personnel-related expenses, consulting, trade shows and advertising. Sales and marketing expenses for the three months ended March 31, 20182019 increased compared to the three months ended March 31, 2017,2018, due primarily to payroll expenses partially offset by lowerand tradeshow expenses.

 

General and Administrative Expenses. General and administrative expenses consist primarily of personnel-related expenses, non-cash stock-based compensation for administrative personnel and members of the board of directors, professional fees, such as accounting and legal, and corporate insurance. General and administrative expenses for the three months ended March 31, 20182019 increased compared to the three months ended March 31, 2017,2018, due primarily to an increase in payroll expenses, taxes, investor relations consulting stock compensation expensefees and information technology expenses.accounting fees due to the audit of our internal controls over financial reporting.

Acquisition costs. Acquisition expenses consist primarily of legal and consulting fees. Acquisition costs for the three months ended March 31, 2019 consist of legal and consulting fees related to the Astero acquisition. See Note 11.

 

1415

 

Other Income (Expense)

 

Interest expense. The interest expense in the three months ended March 31, 2019 and 2018 is due to equipment financing. Interest expense in the three months ended March 31, 2017 is due to the note payable related to the credit facility financing arrangement entered into in May 2016.

Amortization of debt discount. The amortization of short-term debt discount in the three months ended March 31, 2017 is due to the amortization of the allocated value of the detachable warrants associated with the credit facility financing arrangement entered into in May 2016.

 

Loss on equity method investment. The non-cash loss associated with our proportionate share of the net loss in our investment in SAVSU for the period based on our 44.4% and 26.7% ownership as of March 31, 2019 and 2018, and our 45% ownership as of March 31, 2017.respectively.

  

Interest income. The increase in interest income in the three months ended March 31, 20182019 compared to the same period in 20172018 is due to the increased cash balances in 20182019 compared to 2017.2018.

 

Liquidity and Capital Resources

 

On March 31, 2018,2019, we had $7.0$31.8 million in cash and cash equivalents, compared to cash and cash equivalents of $6.7$30.7 million at December 31, 2017. During2018. As noted in Note 11, on April 1, 2019, we paid $8.0 million for the three month period ended March 31, 2018, 12,000 warrants were exercised with a weighted average exercise priceupfront payment for the acquisition of $4.75, yielding $57,000 in proceedsAstero and we also placed $4.5 million into an escrow account which will be paid upon the completion of certain product development milestones. In addition, we are obligated to the Company in which the stock was issued April 3, 2018. Subsequentpay up to quarter end through May 8, 2018, an additional 920,116 warrants were exercised with a weighted average exercise price of $4.75, yielding $4.4$8.0 million in proceeds tocash over the Company.next three years based on attainment of specific revenue targets. Based on our current expectations with respect to our revenue and operating expenses, we expect that our current level of cash and cash equivalents will be sufficient to meet our liquidity needs for at least the next twelve months.foreseeable future in excess of one year. If our revenues do not grow as expected and/orand if we are not able to manage our expenses sufficiently, including making dividend payments pursuant to the terms of the preferred stock issued to WAVI, we may needbe required to obtain additional equity or debt financing. We may also seek equity or debt financing opportunistically if we believe that market conditionsour cash resources are conducive to obtaining such financing. We currently have an S-3 registration statement filed with the SEC which may be utilized to obtain additional financing.depleted.

 

We continue to monitor and evaluate opportunities to strengthen our balance sheet and competitive position over the long term. These actions may include acquisitions or other strategic transactions (including, potentially, the exercise of our option to purchase the remaining 56% of SAVSU that we do not currently own) that we believe would generate significant advantages and substantially strengthen our business. The consideration we pay in such transactions may include, among other things, shares of our common stock, other equity or debt securities of our Company or cash. We may elect to seek debt or equity financing in anticipation of, or in connection with, such transactions or to fund or invest in any operations acquired thereby. We may also seek equity or debt financing opportunistically for these purposes if we believe that market conditions are conducive to obtaining such financing. 

 

Net Cash Provided by/Used Inby Operating Activities

 

During the three months ended March 31, 2018,2019, net cash provided by operating activities was $0.4$1.1 million compared to net cash used in operating activities of $0.2$0.4 million for the three months ended March 31, 2017.2018. The increase in cash from operating activities was the result of increased sales and gross margins.

 

Net Cash Used In Investing Activities

 

Net cash used by investing activities totaled $41,000$156,000 during the three months ended March 31, 20182019 compared to $37,000$41,000 for the three months ended March 31, 2017.2018. Both period investing activities were the result of purchases of property and equipment.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities totaled $177,000 during the three months ended March 31, 2019, compared to $18,000 during the three months ended March 31, 2018, compared to $1.1 million during2018. Net cash provided by financing activities in the three months ended March 31, 2017.2019 was the result of proceeds received from stock option exercises and warrant exercises. Net cash provided by financing activities in the three months ended March 31, 2018 was the result of proceeds received from employee stock option exercises and a warrant exercise partially offset by a preferred stock dividend payment. Net cash provided by financing activities in the three months ended March 31, 2017 was the result of proceeds received from our credit facility and employee stock option exercises.

 

Off-Balance Sheet Arrangements

 

As of March 31, 2018,2019, we did not have any off-balance sheet arrangements.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate estimates, including, but not limited to those related to accounts receivable allowances, determination of fair value of share-based compensation, contingencies, income taxes, useful lives and impairment of intangible assets and internal use software, and expense accruals. We base our estimates on historical experience and on other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

 

1516

 

Our critical accounting policies and estimates have not changed significantly from those policies and estimates disclosed under the heading “Critical Accounting Policies and Significant Judgments and Estimates” in Part II, Item 7, “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017,2018, filed with the SEC.

 

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, 2017,2018, as filed with the SEC on March 9, 2018.15, 2019. There have been no significant changes to these obligations in the three months ended March 31, 2018.2019. For more information regarding our current contingencies and commitments, see noteNote 8 and 10 to the financial statements included above.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk   

 

Not applicable.

 

Item 4. Controls and Procedures   

 

Evaluation of Disclosure Controls and Procedures. We maintain disclosure controls and procedures that are designed to ensure that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to ensure that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer as appropriate, to allow timely decisions regarding required disclosure. During the quarter ended March 31, 2018,2019, we carried out an evaluation, under the supervision and with the participation of our management, including the chief executive officer and chief financial officer, as required by the rules and regulations under the Exchange Act, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our chief executive officer and chief financial officer concluded that, as of March 31, 2018,2019, our disclosure controls and procedures were effective.

  

Changes in Internal Control over Financial Reporting. There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 20182019 that have materially affected or are 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 over financial reporting will prevent all errors 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 our Company have been detected.

 

PART II: Other Information

 

None

  

Item 6. Exhibits

See accompanying Index to Exhibits included after the signature page of this report for a list of exhibits filed or furnished with this report.

16

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.

Dated: May 11, 2018

/s/ Roderick de Greef

Roderick de Greef

Chief Financial Officer
(Duly authorized officer and principal
financial and accounting officer) 

17

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

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase

 

17

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.

Dated: May 9, 2019

/s/ Roderick de Greef

Roderick de Greef

Chief Financial Officer
(Duly authorized officer and principal
financial and accounting officer) 

18

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

101.SCH

XBRL Taxonomy Extension Schema

101.CAL

XBRL Taxonomy Extension Calculation Linkbase

101.DEF

XBRL Taxonomy Extension Definition Linkbase

101.LAB

XBRL Taxonomy Extension Label Linkbase

101.PRE

XBRL Taxonomy Extension Presentation Linkbase

19