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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 September 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 NASDAQ

 

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 November 5, 2020, there were 39,241,323 shares of the Registrant’s common stock outstanding.

 

 

 

 

 

 

INDEX

 

    Page
PART I - FINANCIAL INFORMATION   3
     
Item 1. Financial Statements:   3
Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019 (unaudited)   3
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2020 and 2019 (unaudited)   4
Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2020 and 2019 (unaudited)   5
Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2020 and 2019 (unaudited)   6
Condensed Consolidated Statements of Cash Flows for the nine months ended September 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   22
Item 3. Quantitative and Qualitative Disclosures about Market Risk   34
Item 4. Controls and Procedures   34
     
PART II - OTHER INFORMATION   35
     
Item 1A. Risk Factors   35
Item 6. Exhibits   36
     
SIGNATURES   37

 

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)

 

   September 30, 2020   December 31, 2019 
ASSETS          
Current assets          
Cash and cash equivalents  $23,186   $10,218 
Short-term investments       19,022 
Accounts receivable, net   3,379    1,731 
Inventory   907    252 
Prepaid expenses and other current assets   1,596    1,264 
Total current assets   29,068    32,487 
Property and equipment, net   11,970    14,911 
Operating lease right-of-use assets   3,110    4,590 
Intangible assets, net   589    731 
Goodwill   278    278 
Other assets   472    602 
TOTAL ASSETS  $45,487   $53,599 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable and accrued expenses  $4,818   $7,095 
Other current liabilities   2,311    2,338 
Current portion of long-term notes payable   1,887    528 
Deferred revenue   25    98 
Total current liabilities   9,041    10,059 
Common stock warrant liability   7,233     
Operating lease liabilities   1,817    2,994 
Other long-term liabilities   872    1,630 
Long-term notes payable   1,964     
Total liabilities   20,927    14,683 
           
Commitments and Contingencies (Note 14)   -    - 
           
STOCKHOLDERS’ EQUITY          
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at September 30, 2020 and December 31, 2019        
Common stock – $.001 par value; 250,000,000 shares authorized; 38,912,005 and 27,374,653 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   39    27 
Additional paid-in capital   492,676    474,174 
Accumulated other comprehensive income       72 
Accumulated deficit   (468,155)   (435,357)
Total stockholders’ equity   24,560    38,916 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $45,487   $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 Nine Months Ended 
   September 30,   September 30, 
   2020   2019   2020   2019 
Net revenues                    
Products  $1,156   $839   $2,528   $1,640 
Services   2,181    556    4,008    2,546 
Total net revenues   3,337    1,395    6,536    4,186 
Cost of sales                    
Products   210    315    825    930 
Services   1,142    330    1,925    1,087 
Total cost of sales   1,352    645    2,750    2,017 
Gross profit   1,985    750    3,786    2,169 
Operating costs and expenses                    
Research and development   2,698    2,956    9,235    13,072 
General and administrative   6,264    16,044    22,080    48,299 
Sales and marketing   1,606    4,988    7,324    12,922 
Restructuring and other charges           2,536     
Total operating costs and expenses   10,568    23,988    41,175    74,293 
Operating loss   (8,583)   (23,238)   (37,389)   (72,124)
Other income (expenses)                    
Change in fair value of common stock warrant liability   1,503        4,444     
Interest (expense) income, net   (58)   27    (135)   126 
Other income, net   57    228    282    650 
Net loss  $(7,081)  $(22,983)  $(32,798)  $(71,348)
Net loss per share, basic and diluted  $(0.18)  $(0.87)  $(0.89)  $(2.94)
Weighted average shares outstanding, basic and diluted   38,761,141    26,405,307    36,743,864    24,273,774 

 

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 Nine Months Ended 
   September 30,   September 30, 
   2020   2019   2020   2019 
Net loss  $(7,081)  $(22,983)  $(32,798)  $(71,348)
Other comprehensive income/(loss):                    
Unrealized gain on available-for-sale securities       113    11    425 
Reclassification of realized gains included in net loss       (129)   (83)   (398)
Comprehensive loss  $(7,081)  $(22,999)  $(32,870)  $(71,321)

 

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 Nine Months Ended September 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 
Stock-based compensation expense           2,179            2,179 
Stock option exercises   208                     
Vesting of restricted stock units   485,614    1    (1)            
Shares withheld for tax withholding   (70,727)       (105)           (105)
Net loss                   (7,081)   (7,081)
Balance – September 30, 2020   38,912,005   $39   $492,676   $   $(468,155)  $24,560 

 

   Number   Amount   Capital   Income   Deficit   Equity 
   For the Three and Nine Months Ended September 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                     
Purchase of ESPP shares   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 
Stock-based compensation expense           5,025            5,025 
Issuance of restricted stock awards   1,590,710    2    (2)            
Vesting of restricted stock units   123,448                     
Other comprehensive loss               (16)       (16)
Net loss                       (22,983)   (22,983)
Balance – September 30, 2019   26,932,764   $27   $466,514   $63   $(414,212)  $52,392 

 

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 Nine Months Ended

September 30,

 
   2020   2019 
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(32,798)  $(71,348)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock based compensation expense   5,963    23,932 
Depreciation and amortization   2,337    2,243 
Amortization of intangible assets   142    146 
Amortization of debt discount   17    40 
Change in fair value of common stock warrant liability   (4,444)    
Change in fair value of contingent consideration       (48)
Loss on abandonment and disposal of property and equipment   1,566    265 
Other non-cash adjustments   (21)   3 
Changes in operating assets and liabilities:          
Accounts receivable   (1,648)   (881)
Inventory   (655)   (10)
Prepaid expenses and other current assets   (332)   126 
Operating lease right-of-use assets   1,348    1,214 
Other assets   130    25 
Accounts payable and accrued expenses   (2,349)   4,095 
Other current liabilities       155 
Deferred revenue   (73)   (36)
Operating lease liabilities   (1,353)   (1,142)
Other long-term liabilities       571 
Net cash used in operating activities   (32,170)   (40,650)
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchase of property and equipment   (1,225)   (2,386)
Purchase of available-for-sale securities   (14,144)   (29,002)
Proceeds from maturities of available-for-sale securities   16,945    14,636 
Proceeds from sale of available-for-sale securities   16,171    1,877 
Net cash provided by (used in) investing activities   17,747    (14,875)
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   (114)   (679)
Payment of contingent consideration liability       (109)
Principal payments on financing leases   (376)   (336)
Proceeds from term note payable and financing arrangements   4,630     
Principal payments on term note payable and financing arrangements   (1,096)   (263)
Net cash provided by financing activities   27,391    27,125 
Net increase (decrease) in cash and cash equivalents   12,968    (28,400)
Cash and cash equivalents - beginning of period   10,218    55,673 
Cash and cash equivalents - end of period  $23,186   $27,273 
Non-cash investing and financing activities:          
Unpaid liability for acquisition of property and equipment  $10   $249 
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  $5   $ 
Allocation of proceeds from sale of common stock and warrants to warrant liability  $11,677   $ 
Property and equipment acquired through finance lease  $   $2,341 
Property and equipment acquired through financing arrangement  $   $58 

 

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 periods presented. 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 consolidated 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 September 30, 2020, the Company had an accumulated deficit of $468.2 million. As of September 30, 2020, the Company had cash and cash equivalents of $23.2 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.

 

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.

 

8

 

 

The Company does not expect existing cash as of September 30, 2020 to be sufficient to fund the Company’s operations for at least twelve months from the date of filing. 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. 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. No adjustments have been made to these consolidated financial statements as a result of these uncertainties.

 

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.

 

9

 

 

Revenue Recognition. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration that 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.

 

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.

 

For the three months ended September 30, 2020 revenue from two hospital systems accounted for 55% of total revenue in the regenerative medicine product segment. For the nine months ended September 30, 2020 revenue from one hospital system accounted for 33% of total revenue in the regenerative medicine product segment. As of September 30, 2020, accounts receivable from the two hospital systems represented 10% of total accounts receivable.

 

For the three months ended September 30, 2020 revenue from 32 facilities controlled by a single company accounted for 94% of COVID-19 testing revenues. For the nine months ended September 30, 2020 revenue from 32 facilities controlled by a single company accounted for 96% of COVID-19 testing revenues. As of September 30, 2020, accounts receivable from the 32 facilities represented 40% of total accounts receivable.

 

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.

 

10

 

 

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.

 

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 net 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. Further, any gain on the warrant liability may be considered dilutive when the average market price of the common stock during the period exceeds the exercise price of the warrant.

 

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

 

 

In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The ASU aligns the requirements of capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. Adoption of the ASU is either retrospective or prospective. The Company adopted this standard prospectively 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.

 

 

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 nine months ended September 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):

 

 

    September 30, 2020  
    Level 1     Level 2     Level 3     Total  
Liabilities:                                
Common stock warrant liability   $     $     $ 7,233     $ 7,233  
Total   $     $     $ 7,233     $ 7,233  

 

   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 $7.2 million as of September 30, 2020.

 

12

 

 

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

 

 

   September 30, 2020  

February 14, 2020

 
Stock price  $1.04   $1.69 
Exercise price  $2.80   $2.80 
Risk-free rate   0.41%   1.51%
Volatility   99.6%   93.40%
Term   6.37    6.99 

 

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

 

5. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS

 

During the nine months ended September 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 nine months ended September 30, 2020 and 2019, the Company recognized net realized gains on available-for-sale securities of $0.1 million and $0.4 million, respectively.

 

6. PROPERTY AND EQUIPMENT, NET

 

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

 

 

   September 30, 2020   December 31, 2019 
Machinery and equipment  $12,215   $12,083 
Land and buildings   2,000    2,000 
Computers and software   1,240    1,189 
Leasehold improvements   3,057    2,282 
Construction in progress   169    1,606 
Furniture and equipment   233    470 
Total property and equipment, gross   18,914    19,630 
Accumulated depreciation and amortization   (6,944)   (4,719)
Total property and equipment, net  $11,970   $14,911 

 

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 Nine Months Ended 
   September 30,   September 30, 
   2020   2019   2020   2019 
General and administrative expense  $402   $407   $1,202   $1,171 
Research and development expense   386    390    1,135    1,072 
Total depreciation and amortization expense  $788   $797   $2,337   $2,243 

 

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. In May 2020, the Company reduced space under one of its facility leases, which resulted in a remeasurement of the operating lease liability. See Note 15 for further discussion of the modification.

 

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

 

   Operating leases   Finance leases 
2020 (excluding the nine months ended September 30, 2020)  $416   $166 
2021   1,646    656 
2022   1,345    405 
2023   132    336 
2024   86    42 
Total lease payments   3,625    1,605 
Less imputed interest   (369)   (206)
Total lease liabilities  $3,256   $1,399 

 

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

  

Finance leases

 

  

September 30,

2020

  

December 31,

2019

 
Finance lease right-of-use assets included within property and equipment, net  $1,466   $2,177 
           
Current finance lease liabilities included within other current liabilities  $544   $508 
Non-current finance lease liabilities included within other long-term liabilities   855    1,267 
Total finance lease liabilities  $1,399   $1,775 

 

14

 

 

Operating leases

 

  

September 30,

2020

  

December 31,

2019

 
Current operating lease liabilities included within other current liabilities  $1,439   $1,746 
Operating lease liabilities – non current   1,817    2,994 
Total operating lease liabilities  $3,256   $4,740 

 

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

 

   For the Three Months Ended   For the Nine Months Ended 
   September 30,   September 30, 
   2020   2019   2020   2019 
Operating lease costs included within operating costs and expenses  $531   $556   $1,635   $1,617 
Finance lease costs:                    
Amortization of right-of-use assets  $175   $171   $524   $479 
Interest on lease liabilities   36    42    118    109 
Total  $211   $213   $642   $588 

 

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

 

   For the Nine Months Ended September 30,