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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 June 30, 2020

 

Commission File No. 001-32404

 

POLARITYTE, INC.

(Exact name of registrant as specified in its charter)

 

delaware   06-1529524
(State or Other Jurisdiction of   (I.R.S. Employer
Incorporation or Organization)   Identification No.)

 

1960 S. 4250 West, Salt Lake City, UT 84104

(Address of principal executive offices)

 

Registrant’s Telephone Number, Including Area Code: (800) 560-3983

 

 

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

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

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, Par Value $0.001   PTE   Nasdaq Capital Market
Preferred Stock Purchase Rights    -   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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such 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 definition 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 Exchange Act).

Yes ☐ No

 

As of August 3, 2020, there were 38,740,704 shares of the Registrant’s common stock outstanding.

 

 

 

 

INDEX

 

    Page
PART I - FINANCIAL INFORMATION    
     
Item 1. Financial Statements:   3
Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019 (unaudited)   3
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2020 and 2019 (unaudited)   4
Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2020 and 2019 (unaudited)   5
Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2020 and 2019 (unaudited)   6
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019 (unaudited)   7
Notes to Condensed Consolidated Financial Statements (unaudited)   8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   21
Item 3. Quantitative and Qualitative Disclosures about Market Risk   31
Item 4. Controls and Procedures   31
   
PART II - OTHER INFORMATION    
     
Item 1A. Risk Factors   32
Item 6. Exhibits   33
     
SIGNATURES   34

 

2

 

 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements:

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share and per share amounts)

 

   June 30, 2020   December 31, 2019 
ASSETS          
Current assets          
Cash and cash equivalents  $30,504   $10,218 
Short-term investments       19,022 
Accounts receivable, net   2,115    1,731 
Inventory   281    252 
Prepaid expenses and other current assets   2,453    1,264 
Total current assets   35,353    32,487 
Property and equipment, net   12,729    14,911 
Operating lease right-of-use assets   3,559    4,590 
Intangible assets, net   636    731 
Goodwill   278    278 
Other assets   599    602 
TOTAL ASSETS  $53,154   $53,599 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable and accrued expenses  $5,050   $7,095 
Other current liabilities   2,644    2,338 
Current portion of long-term notes payable   1,436    528 
Deferred revenue   97    98 
Total current liabilities   9,227    10,059 
Common stock warrant liability   8,736     
Operating lease liabilities   2,192    2,994 
Other long-term liabilities   1,022    1,630 
Long-term notes payable   2,410     
Total liabilities   23,587    14,683 
           
Commitments and Contingencies (Note 14)          
           
STOCKHOLDERS’ EQUITY          
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2020 and December 31, 2019        
Common stock – $.001 par value; 250,000,000 shares authorized; 38,496,910 and 27,374,653 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively   38    27 
Additional paid-in capital   490,603    474,174 
Accumulated other comprehensive income       72 
Accumulated deficit   (461,074)   (435,357)
Total stockholders’ equity   29,567    38,916 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $53,154   $53,599 

 

The accompanying notes are an integral part of these condensed consolidated financial statements

 

3

 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except share and per share amounts)

 

   2020   2019   2020   2019 
   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
Net revenues                    
Products  $944   $504   $1,372   $801 
Services   1,322    822    1,827    1,990 
Total net revenues   2,266    1,326    3,199    2,791 
Cost of sales                    
Products   275    342    615    615 
Services   607    254    783    757 
Total cost of sales   882    596    1,398    1,372 
Gross profit   1,384    730    1,801    1,419 
Operating costs and expenses                    
Research and development   3,164    4,764    6,537    10,116 
General and administrative   5,211    15,060    15,816    32,255 
Sales and marketing   2,024    3,981    5,718    7,934 
Restructuring and other charges   2,084        2,536     
Total operating costs and expenses   12,483    23,805    30,607    50,305 
Operating loss   (11,099)   (23,075)   (28,806)   (48,886)
Other income (expenses)                    
Change in fair value of common stock warrant liability   (1,591)       2,941     
Interest (expense) income, net   (65)   29    (77)   99 
Other income, net   78    254    225    422 
Net loss  $(12,677)  $(22,792)  $(25,717)  $(48,365)
Net loss per share, basic and diluted  $(0.33)  $(0.92)  $(0.72)  $(2.09)
Weighted average shares outstanding, basic and diluted   38,428,289    24,768,453    35,724,141    23,190,343 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements

 

4

 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited, in thousands)

 

   2020   2019   2020   2019 
   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
Net loss  $(12,677)  $(22,792)  $(25,717)  $(48,365)
Other comprehensive income/(loss):                    
Unrealized gain on available-for-sale securities   7    160    11    312 
Reclassification of realized gains included in net loss   (10)   (134)   (83)   (269)
Comprehensive loss  $(12,680)  $(22,766)  $(25,789)  $(48,322)

 

The accompanying notes are an integral part of these condensed consolidated financial statements

 

5

 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share and per share amounts)

 

   Number   Amount   Capital   Income   Deficit   Equity 
   For the Three and Six Months Ended June 30, 2020 
   Common Stock   Additional Paid-in   Accumulated Other Comprehensive   Accumulated   Total Stockholders’ 
   Number   Amount   Capital   Income   Deficit   Equity 
Balance – December 31, 2019   27,374,653   $27   $474,174   $72   $(435,357)  $38,916 
Issuance of common stock, net of issuance costs of $1.3 million   10,854,710    11    12,588            12,599 
Stock-based compensation expense           3,221            3,221 
Stock option exercises   10,000        31            31 
Vesting of restricted stock units   158,513                     
Shares withheld for tax withholding   (4,587)       (5)           (5)
Other comprehensive loss               (69)       (69)
Net loss                   (13,040)   (13,040)
Balance – March 31, 2020   38,393,289   $38   $490,009   $3   $(448,397)  $41,653 
Stock-based compensation expense           563            563 
Purchase of ESPP shares   38,293        40            40 
Vesting of restricted stock units   119,132                     
Shares withheld for tax withholding   (6,918)       (9)           (9)
Forfeiture of restricted stock awards   (46,886)                    
Other comprehensive loss               (3)       (3)
Net loss                   (12,677)   (12,677)
Balance – June 30, 2020   38,496,910   $38   $490,603   $   $(461,074)  $29,567 

 

 

   Number   Amount   Capital   Income   Deficit   Equity 
   For the Three and Six Months Ended June 30, 2019 
   Common Stock   Additional Paid-in   Accumulated Other Comprehensive   Accumulated   Total Stockholders’ 
   Number   Amount   Capital   Income   Deficit   Equity 
Balance – December 31, 2018   21,447,088   $21   $414,840   $36   $(342,864)  $72,033 
Stock-based compensation expense           10,327            10,327 
Stock option exercises   283,250    1    528            529 
Vesting of restricted stock units   100,912                     
Shares withheld for tax withholding   (82,011)       (740)           (740)
Other comprehensive income               17        17 
Net loss                   (25,573)   (25,573)
Balance – March 31, 2019   21,749,239   $22   $424,955   $53   $(368,437)  $56,593 
Proceeds received from issuance of common stock, net of issuance costs of $1,146   3,418,918    3    27,945            27,948 
Stock-based compensation expense           8,618            8,618 
Stock option exercises   9,167                     
Shares issued under the ESPP   7,260        35            35 
Vesting of restricted stock units   51,440                     
Shares withheld for tax withholding   (17,418)       (62)           (62)
Other comprehensive income               26        26 
Net loss                   (22,792)   (22,792)
Balance – June 30, 2019   25,218,606   $25   $461,491   $79   $(391,229)  $70,366 

 

The accompanying notes are an integral part of these condensed consolidated financial statements

 

6

 

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

   2020   2019 
  

For the Six Months Ended

June 30,

 
   2020   2019 
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(25,717)  $(48,365)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock based compensation expense   3,784    18,907 
Depreciation and amortization   1,549    1,446 
Amortization of intangible assets   95    99 
Amortization of debt discount   13    28 
Change in fair value of common stock warrant liability   (2,941)    
Change in fair value of contingent consideration       (48)
Loss on abandonment of property and equipment   1,529      
Other non-cash adjustments   (21)   30 
Changes in operating assets and liabilities:          
Accounts receivable   (384)   (624)
Inventory   (29)   (26)
Prepaid expenses and other current assets   (1,189)   (486)
Operating lease right-of-use assets   899    791 
Other assets   3    25 
Accounts payable and accrued expenses   (2,109)   (17)
Other current liabilities   9    367 
Deferred revenue   (1)   (126)
Operating lease liabilities   (903)   (670)
Other long-term liabilities       (120)
Net cash used in operating activities   (25,413)   (28,789)
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchase of property and equipment   (1,170)   (2,110)
Purchase of available-for-sale securities   (14,144)   (15,445)
Proceeds from maturities of available-for-sale securities   16,945    9,278 
Proceeds from sale of available-for-sale securities   16,171     
Net cash provided by (used in) investing activities   17,802    (8,277)
CASH FLOWS FROM FINANCING ACTIVITIES          
Net proceeds from the sale of common stock and warrants   24,276    27,948 
Proceeds from stock options exercised   31    529 
Proceeds from ESPP purchase   40    35 
Cash paid for tax withholdings related to net share settlement   (6)   (636)
Payment of contingent consideration liability       (109)
Principal payments on financing leases   (243)   (225)
Proceeds from term note payable and financing arrangements   4,629     
Principal payments on term note payable and financing arrangements   (830)   (262)
Net cash provided by financing activities   27,897    27,280 
Net increase (decrease) in cash and cash equivalents   20,286    (9,786)
Cash and cash equivalents - beginning of period   10,218    55,673 
Cash and cash equivalents - end of period  $30,504   $45,887 
Non-cash investing and financing activities:          
Unpaid liability for acquisition of property and equipment  $   $63 
Reclassification of stock-based compensation expense that was previously classified as a liability to paid-in capital  $   $38 
Unpaid tax liability related to net share settlement  $7   $43 
Allocation of proceeds from sale of common stock and warrants to warrant liability  $11,677   $ 

 

The accompanying notes are an integral part of these condensed consolidated financial statements

 

7

 

 

POLARITYTE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

1. PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION

 

PolarityTE, Inc. (together with its subsidiaries, the “Company”) is a biotechnology company developing and commercializing regenerative tissue products and biomaterials.

 

The accompanying interim condensed consolidated financial statements of the Company are unaudited, but in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the results for the interim period. Accordingly, they do not include all information and notes required by generally accepted accounting principles for complete financial statements. The results of operations for interim periods are not necessarily indicative of results to be expected for the entire fiscal year. The balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (U.S. GAAP) for complete financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2019 filed with the Securities and Exchange Commission on Form 10-K on March 12, 2020.

 

2. LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL

 

The Company has experienced recurring losses and cash outflows from operating activities. As of June 30, 2020, the Company had an accumulated deficit of $461.1 million. As of June 30, 2020, the Company had cash and cash equivalents of $30.5 million. The Company has been funded historically through sales of equity and debt.

 

On April 10, 2019, the Company completed an underwritten offering providing for the issuance and sale of 3,418,918 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $8.51 per share, for net proceeds of approximately $27.9 million, after deducting offering expenses payable by the Company.

 

On December 5, 2019, the Company entered into an Equity Purchase Agreement (the “Purchase Agreement”), with Keystone Capital Partners, LLC (“Keystone”), pursuant to which Keystone has agreed to purchase from the Company up to $25.0 million of shares of its common stock, subject to certain limitations including a minimum stock price of $2.00, at the direction of the Company from time to time during the 36-month term of the Purchase Agreement. Concurrently, the Company entered into a Registration Rights Agreement with Keystone, pursuant to which it agreed to register the sales of its common stock pursuant to the Purchase Agreement under the Company’s existing shelf registration statement on Form S-3 or a new registration statement. On December 19, 2019, the Company sold 54,090 shares under the Purchase Agreement at a purchase price of $2.31 per share, for total proceeds of $0.1 million. During the three months ended March 31, 2020, the Company completed four additional sales of common stock to Keystone under the Purchase Agreement for a total of 216,412 shares generating total gross proceeds of $0.6 million.

 

On February 14, 2020, the Company completed an underwritten offering of 10,638,298 shares of its common stock and warrants to purchase 10,638,298 shares of common stock. Each common share and warrant were sold together for a combined public purchase price of $2.35 before underwriting discount and commission. The exercise price of each warrant is $2.80 per share, the warrants were exercisable immediately, and they will expire February 12, 2027. The net proceeds to the Company from the offering were $22.5 million, after offering expenses payable by the Company. In connection with this agreement, the Company agreed not to sell any additional shares under the Keystone Purchase Agreement for a period of 90 days after the closing date of the offering.

 

The Company entered into a promissory note for $3.6 million under the Paycheck Protection Program on April 12, 2020. Additional details are available in note 12.

 

The Company does not expect existing cash as of June 30, 2020 to be sufficient to fund the Company’s operations for at least twelve months from the date of filing. These financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and settle its liabilities in the normal course of business. The Company has incurred recurring losses and negative cash flows, has not yet generated material revenue from operations, and will require additional funds to maintain its operations. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after these condensed consolidated financial statements are issued.

 

8

 

 

In the second quarter of 2020 the Company took steps to reduce cash burn by reducing payroll expense, adopting a salary and wage reduction, and reducing discretionary spending across the organization to minimal levels. The Company will seek additional capital through equity offerings or debt financing. However, such financing may not be available in the future on favorable terms, if at all. If adequate financing is not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its product development programs, or be unable to continue operations over a longer term.

 

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Principles of Consolidation. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Significant intercompany accounts and transactions have been eliminated in consolidation.

 

Use of estimates. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities or the disclosure of gain or loss contingencies at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Among the more significant estimates included in these financial statements is the extent of progress toward completion of contracts, stock-based compensation, valuation of common stock warrant liability, and the valuation allowances for deferred tax benefits. Actual results could differ from those estimates.

 

Cash and cash equivalents. Cash equivalents consist of highly liquid investments with original maturities of three months or less from the date of purchase.

 

Leases. The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Finance leases are reported in the condensed consolidated balance sheet in property and equipment and other current and long-term liabilities. The short-term portion of operating lease obligations are included in other current liabilities. The classification of the Company’s leases as operating or finance leases along with the initial measurement and recognition of the associated ROU assets and lease liabilities is performed at the lease commencement date. The measurement of lease liabilities is based on the present value of future lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The ROU asset is based on the measurement of the lease liability and also includes any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the lease term. Amortization expense for the ROU asset associated with its finance leases is recognized on a straight-line basis over the term of the lease and interest expense associated with its finance leases is recognized on the balance of the lease liability using the effective interest method based on the estimated incremental borrowing rate.

 

The Company has lease agreements with lease and non-lease components. As allowed under ASC 842, the Company has elected not to separate lease and non-lease components for any leases involving real estate and office equipment classes of assets and, as a result, accounts for the lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement of ASC 842 to leases with a term of 12 months or less for all classes of assets.

 

Revenue Recognition. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

 

9

 

 

The Company records product revenues primarily from the sale of its regenerative tissue products. The Company sells its products to healthcare providers (customers), primarily through direct sales representatives. Product revenues consist of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognizes product revenue upon delivery to the customer.

 

The Company records service revenues from the sale of its preclinical research services and contract services. Preclinical research services include delivery of preclinical studies and other research services to unrelated third parties. These customer contracts generally consist of a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date relative to the total costs expected to be required to satisfy the performance obligation. The Company believes that this method provides an appropriate measure of the transfer of services over the term of the performance obligation based on the remaining services needed to satisfy the obligation. This requires the Company to make reasonable estimates of the extent of progress toward completion of the contract. As a result, unbilled receivables and deferred revenue are recognized based on payment timing and work completed. Generally, a portion of the payment is due upfront and the remainder upon completion of the contract, with most contracts completing in less than a year. Contract services include research and laboratory testing services to unrelated third parties on a contract basis. These customer contracts generally consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes revenue upon delivery of testing results to the customer.

 

Research and Development Expenses. Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed.

 

Accruals for Research and Development Expenses and Clinical Trials. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period.

 

Common Stock Warrant Liability. The Company accounts for common stock warrants issued as freestanding instruments in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. The Company’s warrants under certain change of control situations, could require settlement in cash, which require the warrants to be recorded as liabilities. Warrants classified as liabilities are remeasured each period until settled or until classified as equity.

 

Stock-Based Compensation. The Company measures all stock-based compensation to employees and non-employees using a fair value method and records such expense in general and administrative, research and development, and sales and marketing expenses. For stock options with graded vesting, the Company recognizes compensation expense over the service period for each separately vesting tranche of the award as though the award were in substance, multiple awards based on the fair value on the date of grant.

 

10

 

 

The fair value of options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate is derived from the U.S. Treasury yield curve in effect at the time of the grant. The volatility factor is determined based on the Company’s historical stock prices. Forfeitures are recognized as they occur.

 

The fair value of restricted stock grants is measured based on the fair market value of the Company’s common stock on the date of grant and amortized over the vesting period of, generally, six months to three years.

 

Loss Per Share. Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive.

 

Impairment of Long-Lived Assets. The Company reviews long-lived assets, including property and equipment, intangible assets, and goodwill for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows.

 

Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326), which requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which defers the effective date of Topic 326. As a smaller reporting company, Topic 326 will now be effective for the Company beginning January 1, 2023. As such, the Company plans to adopt this ASU beginning January 1, 2023. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements and related disclosures.

 

Recently Adopted Accounting Pronouncements

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The ASU modifies the disclosure requirements for fair value measurements by removing, modifying or adding certain disclosures. The standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company adopted this standard on January 1, 2020. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

 

11

 

 

4. FAIR VALUE

 

In accordance with ASC 820, Fair Value Measurements and Disclosures, financial instruments were measured at fair value using a three-level hierarchy which maximizes use of observable inputs and minimizes use of unobservable inputs:

 

  Level 1: Observable inputs such as quoted prices in active markets for identical instruments.
     
  Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the market.
     
  Level 3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires significant judgment or estimation.

 

Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. There were no transfers within the hierarchy for any of the periods presented.

 

During the three months ended June 30, 2020, the Company transferred all available-for-sale securities to cash accounts.

 

The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy (in thousands):

 

 

   June 30, 2020 
   Level 1   Level 2   Level 3   Total 
Liabilities:                    
Common stock warrant liability  $   $   $8,736   $8,736 
Total  $   $   $8,736   $8,736 

  

   December 31, 2019 
   Level 1   Level 2   Level 3   Total 
Assets:                    
Money market funds  $2,019   $   $   $2,019 
Commercial paper       11,064        11,064 
Corporate debt securities       8,982        8,982 
U.S. government debt securities       3,770        3,770 
Total  $2,019   $23,816   $   $25,835 
Liabilities:                    
Contingent consideration  $   $   $31   $31 
Total  $   $   $31   $31 

 

The fair value of the common stock warrant liability is estimated using a Monte Carlo simulation model, which uses certain assumptions related to risk-free interest rates, expected volatility, and expected term. The fair value of the warrant liability was $11.7 million upon the issuance date of February 14, 2020 and $8.7 million as of June 30, 2020.

 

12

 

 

The following assumptions were used in estimating the fair value of the warrant liability as of June 30, 2020 and upon the issuance date of February 14, 2020:

 

 

   June 30, 2020   February 14, 2020 
Stock price  $1.24   $1.69 
Exercise price  $2.80   $2.80 
Risk-free rate   0.45%   1.51%
Volatility   97.5%   93.40%
Term   6.62    6.99 

 

The contingent consideration related to the IBEX acquisition of $31,000 outstanding at December 31, 2019, was paid during the six months ended June 30, 2020. As of June 30, 2020, the obligation related to the contingent consideration was fully satisfied.

 

5. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

 

During the three months ended June 30, 2020, the Company transferred all available-for-sale securities to cash accounts.

 

Cash equivalents and short-term investments consisted of the following as of December 31, 2019 (in thousands):

 

 

   December 31, 2019 
   Amortized Cost   Unrealized Gains   Unrealized Losses   Market Value 
Cash equivalents:                    
Money market funds  $2,019   $        $    $2,019 
Commercial paper   1,020    4        1,024 
U.S. government debt securities   3,761    9        3,770 
Total cash equivalents (1)   6,800    13        6,813 
Short-term investments:                    
Commercial paper   9,986    54        10,040 
Corporate debt securities   8,977    5        8,982 
Total short-term investments   18,963    59        19,022 
Total  $25,763   $72   $   $25,835 

 

  (1) Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 2019 in addition to $3.4 million of cash.

 

For the six months ended June 30, 2020 and 2019, the Company recognized net realized gains on available-for-sale securities of $0.1 million and $0.3 million, respectively.

 

6. PROPERTY AND EQUIPMENT, NET

 

The following table presents the components of property and equipment, net (in thousands):

 

 

   June 30, 2020   December 31, 2019 
Machinery and equipment  $12,198   $12,083 
Land and buildings   2,000    2,000 
Computers and software   1,255    1,189 
Leasehold improvements   3,044    2,282 
Construction in progress   179    1,606 
Furniture and equipment   233    470 
Total property and equipment, gross   18,909    19,630 
Accumulated depreciation and amortization   (6,180)   (4,719)
Total property and equipment, net  $12,729   $14,911 

 

The Company abandoned $1.5 million of construction in progress and other equipment during the period ended June 30, 2020. See note 13.

 

13

 

 

Depreciation and amortization expense for property and equipment, including assets acquired under financing leases was as follows (in thousands):

 

   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
General and administrative expense  $408   $407   $800   $764 
Research and development expense   389    363    749    682 
Total depreciation and amortization expense  $797   $770   $1,549   $1,446 

 

7. LEASES

 

The Company leases facilities and certain equipment under noncancelable leases that expire at various dates through November 2024. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases may include options to extend or terminate the lease at the election of the Company. These optional periods have not been considered in the determination of the right-of-use-assets or lease liabilities associated with these leases as the Company did not consider it reasonably certain it would exercise the options.

 

As of June 30, 2020, the maturities of our operating and finance lease liabilities were as follows (in thousands):

 

 

   Operating leases   Finance leases 
2020 (excluding the six months ended June 30, 2020)  $948   $335 
2021   1,646    656 
2022   1,345    405 
2023   132    336 
2024   87    42 
Total lease payments   4,158    1,774 
Less imputed interest   (452)   (242)
Total lease liabilities  $3,706   $1,532 

 

Supplemental balance sheet information related to leases was as follows (in thousands):

 

Finance leases

 

 

   June 30, 2020   December 31, 2019 
Finance lease right-of-use assets included within property and equipment, net  $1,631   $2,177 
           
Current finance lease liabilities included within other current liabilities  $532   $508 
Non-current finance lease liabilities included within other long-term liabilities   1,000    1,267 
Total finance lease liabilities  $1,532   $1,775 

 

Operating leases

 

   June 30, 2020   December 31, 2019 
Current operating lease liabilities included within other current liabilities  $1,514   $1,746 
Operating lease liabilities – non current   2,192    2,994 
Total operating lease liabilities  $3,706   $4,740 

 

14

 

 

The components of lease expense were as follows (in thousands):

 

 

   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
Operating lease costs included within operating costs and expenses  $548   $546   $1,104   $1,061 
Finance lease costs:                    
Amortization of right-of-use assets  $174   $170   $349   $309 
Interest on lease liabilities   39    44    82    67 
Total  $213   $214   $431   $376 

 

Supplemental cash flow information related to leases was as follows (in thousands):

 

 

   For the Six Months Ended June 30, 
   2020   2019 
Cash paid for amounts included in the measurement of lease liabilities:          
Operating cash out flows from operating leases  $1,108   $941 
Operating cash out flows from finance leases  $82   $67 
Financing cash out flows from finance leases  $243   $225 
Lease liabilities arising from obtaining right-of-use assets:          
Finance leases  $   $1,824 
Lease payments made in prior period reclassified to property and equipment  $   $535 
Remeasurement of finance lease liability due to lease modification  $   $(22)
Operating leases  $   $939 
Remeasurement of operating lease liability due to lease modification  $131   $ 

 

As of June 30, 2020 and December 31, 2019, the weighted average remaining lease term for operating leases was 2.5 and 2.8 years, respectively, and the weighted average discount rate used for operating leases was 9.76% and 9.83%, respectively. As of June 30, 2020 and December 31, 2019, the weighted average remaining lease term for finance leases was 3.0 and 3.5 years, respectively, and the weighted average discount rate used for finance leases was 9.77% for both periods. In May 2020, the Company reduced office space related to one of its existing lease agreements resulting in lower monthly payments.

 

8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

The following table presents the major components of accounts payable and accrued expenses (in thousands):

 

   June 30, 2020   December 31, 2019 
Accounts payable  $423   $1,689 
Salaries and other compensation   1,815    1,462 
Legal and accounting   426    1,404 
Accrued severance   1,217    1,053 
Benefit plan accrual   560    557 
Other   609    930 
Total accounts payable and accrued expenses  $5,050   $7,095 

 

Other current liabilities are comprised of the current portion of operating lease liabilities and finance lease liabilities, and short-term debt. The short-term debt had a balance of $0.6 million as of June 30, 2020, while the other components are disclosed in the footnotes above. The short-term debt balance is related to two financing arrangements entered into during the six months ended June 30, 2020 to fund an insurance contract. Under the financing arrangements, the Company borrowed $0.8 million and $0.2 million. The amounts will be repaid in nine equal monthly installments, with an interest rate of 4.25% and 6.35%, respectively.

 

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9. STOCK-BASED COMPENSATION

 

2020, 2019 and 2017 Equity Incentive Plans

 

2020 Plan

 

On October 25, 2019, the Company’s Board of Directors (the “Board”) approved the Company’s 2020 Stock Option and Incentive Plan (the “2020 Plan”). The 2020 Plan became effective on December 19, 2019, the date approved by the stockholders. The 2020 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, unrestricted stock awards, dividend equivalent rights, and cash-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2020 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 3,000,000 shares of common stock are issuable pursuant to awards under the 2020 Plan. No grants of awards may be made under the 2020 Plan after the later of December 19, 2029, or the tenth anniversary of the latest material amendment of the 2020 Plan and no grants of incentive stock options may be made after October 25, 2029. As of June 30, 2020, the Company had 18,000 shares available for future issuances under the 2020 Plan.

 

2019 Plan

 

On October 5, 2018, the Company’s Board approved the Company’s 2019 Equity Incentive Plan (the “2019 Plan”). The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2019 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 3,000,000 shares of common stock are issuable pursuant to awards under the 2019 Plan. Unless earlier terminated by the Board, the 2019 Plan shall terminate at the close of business on October 5, 2028. As of June 30, 2020, the Company had 257,570 shares available for future issuances under the 2019 Plan.

 

2017 Plan

 

On December 1, 2016, the Company’s Board approved the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). The purpose of the 2017 Plan is to promote the success of the Company and to increase stockholder value by providing an additional means through the grant of awards to attract, motivate, retain and reward selected employees, consultants and other eligible persons. The 2017 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2017 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 7,300,000 shares of common stock are issuable pursuant to awards under the 2017 Plan. Unless earlier terminated by the Board, the 2017 Plan shall terminate at the close of business on December 1, 2026. As of June 30, 2020, the Company had 1,177,365 shares available for future issuances under the 2017 Plan.

 

16

 

 

A summary of the Company’s employee and non-employee stock option activity for the six months ended June 30, 2020 is presented below:

 

 

  

Number of

Shares

  

Weighted-

Average

Exercise Price

 
Outstanding – December 31, 2019   4,529,988   $15.26 
Granted   1,458,026   $1.19 
Exercised   (10,000)  $3.12 
Forfeited   (867,432)  $11.78 
Outstanding – June 30, 2020   5,110,582   $11.84 
Options exercisable, June 30, 2020   3,603,571   $14.87 

 

Employee Stock Purchase Plan (ESPP)

 

In May 2018, the Company adopted the Employee Stock Purchase Plan (“ESPP”). The Company has initially reserved 500,000 shares of common stock for purchase under the ESPP. The initial offering period began January 1, 2019 and ended on June 30, 2019 with the first purchase date. Subsequent offering periods will automatically commence on each January 1 and July 1 and will have a duration of six months ending with a purchase date June 30 and December 31 of each year. On each purchase date, ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the offering date or (2) the fair market value of the common stock on the purchase date.

 

Restricted Stock

 

A summary of the Company’s employee and non-employee restricted-stock activity is presented below:

 

  

  

Number of

Shares

 
Unvested - December 31, 2019   1,843,001 
Granted   3,401,036 
Vested (1)   (832,910)
Forfeited   (79,803)
Unvested – June 30, 2020   4,331,324 

 

  (1) The number of vested restricted stock units includes shares that were withheld on behalf of employees to satisfy the minimum statutory tax withholding requirements.

 

Stock-Based Compensation Expense

 

The stock-based compensation expense related to stock options, restricted stock awards, and the employee stock purchase plan was as follows (in thousands):

 

 

   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2020   2019   2020   2019 
General and administrative expense  $143   $6,892   $3,220   $15,929 
Research and development expense   404    1,481    367    2,565 
Sales and marketing expense   16    245    197    413 
Total stock-based compensation expense  $563   $8,618   $3,784   $18,907 

 

10. COMMON STOCK WARRANTS

 

On February 14, 2020, the Company completed an underwritten offering of 10,638,298 shares of its common stock and warrants to purchase 10,638,298 shares of common stock. Each common share and warrant were sold together for a combined public purchase price of $2.35 before underwriting discount and commission. The exercise price of each warrant is $2.80 per share, the warrants were exercisable immediately, and they will expire February 12, 2027. As the warrants could require cash settlement in certain scenarios, the warrants were classified as a liability and are recorded at an estimated fair value using a Monte Carlo simulation model. The total proceeds from the offering were allocated first to the warrant liability based on the estimated fair value with the residual allocated to the common shares. As of June 30, 2020, none of the warrants had been exercised.

 

17

 

 

The change in fair value of the common stock warrant liability is presented in the following table and is reported as a change in fair value of common stock warrant liability in the statements of operations (in thousands):

 

 

   June 30, 2020 
Beginning balance  $ 
Initial value of common stock warrant liability   11,677 
Change in fair value of common stock warrant liability   (2,941)
Ending balance  $8,736 

 

11. LOSS PER SHARE

 

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect:

 

 

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   As of June 30, 
   2020   2019 
Stock options