UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q

(Mark One)
þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended SeptemberJune 30, 20172021

OR
oTRANSITION REPORT UNDERPURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from _____ to _____


Commission file number: 001-31822
ACCELERATE DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware84-1072256
(State or other jurisdiction(I.R.S. Employer Identification No.)
of incorporation or organization)
Delaware84-1072256
(State or other jurisdiction(I.R.S. Employer Identification No.)
of incorporation or organization)
3950 South Country Club Road,Suite 470
Tucson, ArizonaArizona85714
(Address of principal executive offices)(Zip Code)


(520) 365-3100
(Registrant’s telephone number, including area code)


N/A
(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 classTrading SymbolName of each exchange on which registered
Common Stock, $0.001 parAXDXThe Nasdaq Stock Market LLC
value per share(The 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. þ Yes oNo


Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). þ Yes oNo


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

Large accelerated filero
Accelerated filerþ
Non-accelerated filefiler
o (Do not check if a smaller reporting company)
Smaller reporting companyo
Emerging growth companyo


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. o


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). oYes þNo


As of November 1, 2017August 4, 2021, there were 55,397,56361,498,695 shares of the registrant’s common stock outstanding.





TABLE OF CONTENTS





2

PART I - FINANCIAL INFORMATION


Item 1. Financial Statements

ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETSHEETS
Unaudited
(in thousands)thousands, except share data)
June 30,December 31,
20212020
Unaudited
ASSETS
Current assets:
Cash and cash equivalents$44,580 $35,781 
Investments24,251 32,488 
Trade accounts receivable2,114 1,550 
Inventory9,572 9,216 
Prepaid expenses1,680 1,172 
Other current assets1,498 1,780 
Total current assets83,695 81,987 
Property and equipment, net5,548 6,135 
Right of use assets2,848 3,183 
Other non-current assets1,898 2,120 
Total assets$93,989 $93,425 
LIABILITIES AND STOCKHOLDERSDEFICIT
Current liabilities:
Accounts payable$1,877 $1,290 
Accrued liabilities3,832 2,991 
Accrued interest1,262 1,262 
Deferred revenue282 376 
Current portion of long-term debt1,452 553 
Current operating lease liability612 497 
Total current liabilities9,317 6,969 
Non-current operating lease liability2,747 3,063 
Other non-current liabilities580 335 
Long-term debt3,805 4,659 
Convertible notes147,290 141,211 
Total liabilities$163,739 $156,237 
Commitments and contingencies00
Stockholders’ deficit:
Preferred shares, $0.001 par value;
5,000,000 preferred shares authorized and NaN outstanding as of June 30, 2021 and December 31, 2020
Common stock, $0.001 par value;
100,000,000 common shares authorized with 61,489,475 shares issued and outstanding on June 30, 2021 and 85,000,000 common shares authorized with 57,607,939 shares issued and outstanding on December 31, 202061 58 
Contributed capital514,122 475,072 
Treasury stock(45,067)(45,067)
Accumulated deficit(538,879)(492,966)
Accumulated other comprehensive income13 91 
Total stockholders’ deficit(69,750)(62,812)
Total liabilities and stockholders’ deficit$93,989 $93,425 
 September 30,December 31,
 20172016
ASSETS
Current assets:  
Cash and cash equivalents$34,431
$19,244
Investments86,889
58,519
Trade accounts receivable1,111
34
Inventory7,341

Prepaid expenses1,048
468
Other current assets460
183
Total current assets131,280
78,448
Property and equipment, net4,690
4,258
Intellectual property, net137
146
Total assets$136,107
$82,852
   
LIABILITIES AND STOCKHOLDERS EQUITY
Current liabilities:  
Accounts payable$1,369
$992
Accrued liabilities3,733
3,009
Deferred revenue and income1,081
35
Total current liabilities6,183
4,036
Long-term deferred income
1,000
Total liabilities$6,183
$5,036
   
Commitments and contingencies see Note 16, Commitments



   
Stockholders’ equity:  
Common stock, $0.001 par value;  
75,000,000 common shares authorized with 55,397,563 shares issued and outstanding on September 30, 2017 and 75,000,000 authorized with 51,516,309 shares issued and outstanding on December 31, 201655
52
Preferred shares, $0.001 par value;  
5,000,000 preferred shares authorized and none outstanding as of September 30, 2017 and December 31, 2016

Contributed capital355,458
255,257
Accumulated deficit(225,676)(177,289)
Accumulated other comprehensive (loss)87
(204)
Total stockholders’ equity129,924
77,816
Total liabilities and stockholders’ equity$136,107
$82,852

See accompanying notes to condensed consolidated financial statements.

3




ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Unaudited
(in thousands, except per share data)
Three Months EndedSix Months Ended
June 30,June 30,June 30,June 30,
2021202020212020
Net sales$2,798 $2,125 $5,316 $4,468 
Cost of sales1,745 1,171 3,365 2,459 
Gross profit1,053 954 1,951 2,009 
Costs and expenses:
Research and development5,733 5,347 12,629 11,189 
Sales, general and administrative12,910 11,332 26,938 24,275 
Total costs and expenses18,643 16,679 39,567 35,464 
Loss from operations(17,590)(15,725)(37,616)(33,455)
Other income (expense):
Interest expense(4,177)(3,835)(8,267)(7,584)
Foreign currency exchange gain (loss)91 (159)(37)
Interest income12 224 55 604 
Other income (expense), net81 15 74 (67)
Total other expense, net(4,084)(3,505)(8,297)(7,084)
Net loss before income taxes(21,674)(19,230)(45,913)(40,539)
Provision for income taxes
Net loss$(21,674)$(19,230)$(45,913)$(40,539)
Basic and diluted net loss per share$(0.36)$(0.35)$(0.77)$(0.74)
Weighted average shares outstanding61,049 55,445 59,790 55,139 
Other comprehensive loss:
Net loss$(21,674)$(19,230)$(45,913)$(40,539)
Net unrealized (loss) gain on debt securities available-for-sale(44)(18)179 
Foreign currency translation adjustment21 34 (60)19 
Comprehensive loss$(21,652)$(19,240)$(45,991)$(40,341)
 Three Months Ended Nine Months Ended
 September 30,September 30, September 30,September 30,
 20172016 20172016
Net sales$828
$24
 $2,058
$207
      
Cost of sales191

 352

Gross Profit637
24
 1,706
207
      
Costs and expenses:     
Research and development6,351
7,874
 16,166
23,974
Sales, general and administrative11,601
9,566
 33,589
26,710
Total costs and expenses17,952
17,440
 49,755
50,684
      
Loss from operations(17,315)(17,416) (48,049)(50,477)
      
Interest expense and other2

 (3)
Foreign currency exchange loss(40)(42) (73)(115)
Interest and dividend income323
159
 612
353
Total other income285
117
 536
238
      
Net loss before income taxes(17,030)(17,299) (47,513)(50,239)
Provision from income taxes(45)
 (220)
Net loss$(17,075)$(17,299) $(47,733)$(50,239)
      
Basic and diluted net loss per share$(0.31)$(0.34) $(0.89)$(0.98)
Weighted average shares outstanding55,316
51,239
 53,603
51,216
      
Other comprehensive loss:     
Net loss$(17,075)$(17,299) $(47,733)$(50,239)
Net unrealized gain loss on available-for-sale investments(7)(70) (4)11
Foreign currency translation adjustment91
(8) 295
(8)
Comprehensive loss$(16,991)$(17,377) $(47,442)$(50,236)


See accompanying notes to condensed consolidated financial statements.

4





ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTSTATEMENTS OF CASH FLOWS
Unaudited
(in thousands)
Six Months Ended
June 30,June 30,
20212020
Cash flows from operating activities:
Net loss$(45,913)$(40,539)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization1,248 1,571 
Amortization of investment discount97 13 
Equity-based compensation15,429 7,615 
Amortization of debt discount and issuance costs6,079 5,426 
(Gain) loss on disposal of property and equipment(100)527 
Contributions to deferred compensation plan(236)(160)
(Increase) decrease in assets:
Accounts receivable(564)550 
Inventory and instruments in property and equipment(524)(1,979)
Prepaid expense and other60 (360)
Increase (decrease) in liabilities:
Accounts payable564 390 
Accrued liabilities, and other736 (581)
Accrued interest45 
Deferred revenue and income(94)(39)
Deferred compensation245 171 
Net cash used in operating activities(22,928)(27,395)
Cash flows from investing activities:
Purchases of equipment(29)(643)
Purchases of marketable securities(15,699)(21,509)
Maturities of marketable securities23,993 27,844 
Net cash provided by investing activities8,265 5,692 
Cash flows from financing activities:
Proceeds from issuance of common stock22,122 
Proceeds from exercise of options1,222 3,031 
Proceeds from issuance of common stocks under employee purchase plan161 216 
Proceeds from debt4,791 
Net cash provided by financing activities23,505 8,038 
Effect of exchange rate on cash(43)19 
Increase (decrease) in cash and cash equivalents8,799 (13,646)
Cash and cash equivalents, beginning of period35,781 61,014 
Cash and cash equivalents, end of period$44,580 $47,368 
 Nine Months Ended
 September 30,September 30,
 20172016
Cash flows from operating activities:  
Net loss$(47,733)$(50,239)
Adjustments to reconcile net loss to net cash used in operating activities:



Depreciation1,595
1,745
Amortization of intangible assets9
8
Amortization of investment discount298
251
Equity-based compensation10,970
6,591
Realized (gain) on sale of investments
(6)
Loss on disposal of property & equipment3

(Increase) decrease in assets:



Accounts receivable(1,077)(82)
Inventory(7,079)
Prepaid expense and other(392)525
Other current assets(277)(90)
Increase (decrease) in liabilities:



Accounts payable359
103
Accrued liabilities780
670
Deferred revenue and income46
(83)
Net cash used in operating activities(42,498)(40,607)
Cash flows from investing activities:  
Purchases of equipment(2,055)(2,301)
Purchases of available-for-sale securities(68,423)(73,585)
Sales of available-for-sale securities9,522
8,716
Maturity of available-for-sale securities30,049
14,955
Net cash used in investing activities(30,907)(52,215)
Cash flows from financing activities:  
Issuance of common stock net issuance costs83,741
80
Exercise of options and warrants4,562
864
Common stock issuance costs
(814)
Payments on capital lease obligations
(13)
Recovery of related party short-swing profits
866
Net cash provided by financing activities88,303
983
   
Effect of exchange rate on cash:289
(15)
   
Increase (decrease) in cash and cash equivalents15,187
(91,854)
Cash and cash equivalents, beginning of period19,244
120,585
Cash and cash equivalents, end of period$34,431
$28,731


See accompanying notes to condensed consolidated financial statements.

5





ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (CONTINUED)
Unaudited
(in thousands)
Six Months Ended
June 30,June 30,
20212020
Non-cash investing activities:
Net transfer of instruments from inventory to property and equipment$500 $1,288 
Supplemental cash flow information:
Interest paid$2,144 $2,144 
Income taxes paid, net of refunds$$26 

See accompanying notes to condensed consolidated financial statements.
6



ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' DEFICIT
Unaudited
(in thousands)
Three Months EndedSix Months Ended
June 30,June 30,
2021202020212020
Common stock shares outstanding
Beginning59,561 54,994 57,608 54,709 
Issuance of common stock1,481 — 2,870 — 
Exercise of options436 1,247 990 1,517 
Issuance of common stock under employee purchase plan11 21 23 
Ending61,489 56,249 61,489 56,249 
Common stock
Beginning$60 $55 $58 $55 
Proceeds from issuance of common stock— — 
Exercise of Options— 
Ending$61 $56 $61 $56 
Contributed capital
Beginning$495,857 $457,987 $475,072 $452,344 
Proceeds from issuance of common stock11,455 — 22,120 — 
Exercise of options113 1,713 1,221 3,031 
Issuance of common stock under employee purchase plan81 104 161 215 
Equity-based compensation6,616 3,374 15,548 7,588 
Ending$514,122 $463,178 $514,122 $463,178 

See accompanying notes to condensed consolidated financial statements.
7



ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' DEFICIT (CONTINUED)
Unaudited
(in thousands)
Three Months EndedSix Months Ended
June 30,June 30,
2021202020212020
Accumulated deficit
Beginning$(517,205)$(436,067)$(492,966)$(414,653)
Cumulative effect of accounting changes— — — (105)
Net loss(21,674)(19,230)(45,913)(40,539)
Ending$(538,879)$(455,297)$(538,879)$(455,297)
Treasury stock
Beginning$(45,067)$(45,067)$(45,067)$(45,067)
Ending$(45,067)$(45,067)$(45,067)$(45,067)
Accumulated other comprehensive (loss) income
Beginning$(9)$150 $91 $(58)
Net unrealized (loss) gain on debt securities available-for-sale(44)(18)179 
Foreign currency translation adjustment21 34 (60)19 
Ending$13 $140 $13 $140 
Total stockholders' deficit$(69,750)$(36,990)$(69,750)$(36,990)

See accompanying notes to condensed consolidated financial statements.

8


ACCELERATE DIAGNOSTICS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Unaudited


NOTE 1. ORGANIZATION AND NATURE OF BUSINESS; BASIS OF PRESENTATION; PRINCIPLES OF CONSOLIDATION; SIGNIFICANT ACCOUNTING POLICIES


Accelerate Diagnostics, Inc. (“we” or “us” or “our” or “Accelerate” or “the Company”the “Company”) is an in vitro diagnostics company dedicated to providing solutions whichthat improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections.


Basis of Presentation


The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”) and applicable rules and regulations of the United StatesU.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2020, as filed with the SEC on February 28, 2017.March 2, 2021.


The condensed consolidated balance sheet as of December 31, 20162020 included herein was derived from the audited financial statements as of that date but does not include all disclosures such as notes required by U.S. GAAP.


The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods presented, but are not necessarily indicative of the results of operations to be anticipated for the entire year ending December 31, 2017,2021, or any future period.


All amounts are rounded to the nearest thousand dollars unless otherwise indicated.

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 and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.


Principles of Consolidation


The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries after elimination of intercompany transactions and balances.


Use of Estimates

The preparation of the Company’s condensed consolidated financial statements requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and the related disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions relate to accounts receivable, inventory, property and equipment, accrued liabilities, warranty liabilities, tax valuation accounts, equity–based compensation, revenue and leases. Actual results could differ materially from those estimates.

Estimated Fair Value of Financial Instruments

The Company follows Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, which has defined fair value and requires the Company to establish a framework for measuring and disclosing fair value. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three-tiered approach and fair value measurement to be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

9


Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability;

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e. supported by little or no market activity).

The carrying amounts of financial instruments such as cash and cash equivalents, trade accounts receivable, prepaid expenses, other current assets, accounts payable, accrued liabilities, and other current liabilities approximate the related fair values due to the short-term maturities of these instruments.

The estimated fair value of the Company’s convertible note represents a Level 2 measurement. See Note 10, Convertible Notes for further detail on the Company’s convertible notes.

The estimated fair value of the Company’s long-term debt represents a Level 3 measurement. The promissory notes issued under the Paycheck Protection Program (PPP) and other long-term debt is privately held with no public market. The carrying amount of these notes approximates fair value. See Note 9, Long-Term Debt for further detail on the Company’s long-term debt.

Cash and Cash Equivalents


All highly liquid investments with an original maturity of three months or less at time of purchase are considered to be cash equivalents. Cash and cash equivalents include overnight repurchase agreement accounts and other investments. As part of our cash management process, excess operating cash is invested in overnight repurchase agreements with our bank. Repurchase agreements and other investments classified as cash and cash equivalents are not deposits and are not insured by the U.S. Government, the FDIC or any other government agency and involve investment risk including possible loss of principal. We believe, however, that the market risk arising from holding these financial instruments is minimal.


Investments


The Company invests excess funds in various investmentsdebt and equity securities which are primarily held in the custody of major financial institutions. InvestmentsDebt securities consist of debt securities incertificates of deposit, U.S. government and agency securities, commercial paper, and corporate debtnotes and bonds. Equity securities and certificatesconsist of deposit. Management classifies its investments as available-for-sale investments and


mutual funds. The Company records these investments in the condensed consolidated balance sheet at fair value. Unrealized gains or losses for debt securities available-for-sale are included in accumulated other comprehensive income, a component of stockholders’ deficit. Unrealized gains or losses for equity securities are included in other income (expense), net. The Company considers all debt securities available-for-sale, securities, including those with maturity dates beyond 12 months, as available to support current operational liquidity needs. Unrealized gains or losses for available-for-sale securities are included in accumulated other comprehensive income or loss, a component of stockholders’ equity. The Company classifies its investments as current based on the nature of the investments and their availability for use in current operations.


The Company assessesWe perform an assessment to determine whether there have been any events or economic circumstances to indicate that a debt security available-for-sale in an other-than-temporaryunrealized loss position has suffered impairment as a result of credit loss has occurred due to declines inor other factors. A debt security is considered impaired if its fair value or other market conditions when an investment’s fair value remainsis less than its cost for more than twelve months. This assessment includes a determination of whether the investment is expected to recover in value and whether the Company has the intent and ability to hold the investment until the anticipated recovery in value occurs. When an investment is identified as having an other-than-temporary impairment loss, we adjust theamortized cost basis at the reporting date.

If we intend to sell the debt security or if it is more-likely-than-not that we will be required to sell the debt security before the recovery of its amortized cost basis, the impairment is recognized and the unrealized loss is recorded as a direct write-down of the investment down to fair value resulting in a realized loss. The newsecurity's amortized cost basis with an offsetting entry to earnings. If we do not intend to sell the debt security or believe we will not be required to sell the debt security before the recovery of its amortized cost basis, the impairment is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income.

Reclassification

Certain prior year amounts have been reclassified for consistency withassessed to determine if a credit loss component exists. We use a discounted cash flow method to determine the current year presentation and had no effect on our net income, stockholders’ equity or cash flows.credit loss component. In the current period presentation andevent a credit loss exists, an allowance for credit losses is recorded in earnings for the revised prior period presentation, depreciation and amortization expenses are reported as acredit loss component of the individual costs and expenses as partimpairment while the remaining portion of the condensed consolidated statementsimpairment attributable to factors other than credit loss is recognized, net of operations andtax, in accumulated other comprehensive loss.income. The amount of depreciation and amortization expenses now reported as a component of research and development costs forimpairment recognized due to credit factors is limited to the three months endedSeptember 30, 2017 and 2016 were $303,000 and $342,000, respectively, and for the nine months endedSeptember 30, 2017 and 2016 were $1,086,000 and $1,026,000, respectively. The amount of depreciation and amortization expenses now reported as a component of sales, general and administrative costs for the three months endedSeptember 30, 2017 and 2016 were $168,000 and $259,000, respectively, and for the nine months endedSeptember 30, 2017 and 2016 were $435,000 and $727,000, respectively.

In the current and revised prior period presentation, product sales and licensing and royalty revenues are reported as net sales as partexcess of the condensed consolidated statementsamortized cost basis over the fair value of operations and comprehensive loss. The amounts that have been reclassified had no effect on our net income, stockholders’ equity or cash flows.the security.

10


Inventory


Inventory is stated at the lesser of cost or net realizable value, with cost determined on the first-in-first-out method. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expense and spoilage are expensed as incurred and not included in overhead subject to capitalization. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration. The Company adopted Accounting Standards Update (“ASU”) 2015-11, Simplifying the Measurement of Inventory (Topic 310) Inventory on January 1, 2017. This ASU simplifies the subsequent measurement of inventory by using only the lower of cost or net realizable value. The adoptionCompany determines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate.

Accounts Receivable

Accounts receivable consist of amounts due to the Company for sales to customers and are based on what we expect to collect in exchange for goods and services. Receivables are considered past due based on the contractual payment terms and are written off if reasonable collection efforts prove unsuccessful.

We maintain an allowance for credit losses for expected uncollectible accounts receivable, which is recorded as an offset to accounts receivable and changes in such are classified as general and administrative expense in the condensed consolidated statements of operations. We assess collectibility by reviewing accounts receivable on a collective basis where similar characteristics exist and on an individual basis when we identify specific customers with known disputes or collectibility issues. In determining the amount of the allowance for credit losses, we consider historical collectibility and make judgments about the creditworthiness of customers based on credit evaluations. Our customers typically have good credit quality. We also consider customer-specific information, current market conditions and reasonable and supportable forecasts of future economic conditions to inform adjustments to historical loss data. The allowance for credit losses at June 30, 2021 and December 31, 2020 was $0.2 million and $0.4 million, respectively.

The allowance for credit losses for the three and six months ended June 30, 2021 and 2020 is comprised of the following (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Beginning balance$209 $110 $445 $
Provisions(12)38 98 
Write-offs(3)43 (270)43 
Recoveries
Ending balance$213 $141 $213 $141 

The write-offs recorded during the six months ended June 30, 2021 were in connection with a one time restructuring activity of the Company's Europe, Middle East and Africa (“EMEA”) business. These credit losses were incurred as part of the Company terminating agreements with select distributors in geographies it exited and did not have an effect on the Company’s consolidated financial statements.pursue collection of these accounts receivables. The credit losses and bad debt expense was accrued as of December 31, 2020.


Property and Equipment


Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred and expenditures for major improvements are capitalized. Gains and losses from retirement or replacement are included in costs and expenses. Depreciation of property and equipment is computed using the straight-line method over the estimated useful life of the assets, ranging from greater than one year to seven years. Leasehold improvements are depreciated over the remaining life of the lease or the life of the asset, whichever is less.


Instruments Classified as Property and Equipment

Property and equipment includes diagnosticAccelerate Pheno systems (also referred to as instruments) used for sales demonstrations, instruments under rental agreements and instruments used for research and development. Depreciation expense for instruments used for sales demonstrations is recorded as a component of sales, general and administrative expense. Depreciation expense for instruments under placed at customer sites pursuant to reagent
11


rental agreements.agreements is recorded as a component of cost of sales. Depreciation expense for instruments used in our laboratory and research is recorded as a component of research and development expense. The Company retains title to thethese instruments under these arrangements.

Revenue

The Company recognizes revenue in accordance with ASC 605, Revenue Recognition, when persuasive evidence of an arrangement exists, the price is fixed or determinable, collection is reasonably assured and delivery of products has occurred or services have been rendered. Additional considerations include whether the applicable fee arrangement contains future delivery or performance obligations that should be divided into separate accounting


units, whether the arrangement requires the Company to retain risks consistent with a collaborative arrangement, and/or whether any of the fees are contingent on the achievement of future milestones.

Product revenue is deriveddepreciates them over five years. Losses from the sale or rentalretirement of ourreturned instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment.

We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrumentare included in the customer’s facility and provide service. The customer agrees to purchase consumable products at a stated price over the term of the agreement which is typically less than seven years. Contracts sometimes have renewal clauses but such clauses do not provide for a bargain renewal option or penalize the customer if they do not renew. The instrument remains the Company’s property throughout the term of the agreement and there is no transfer of title upon expiration. Revenue is recognized as consumable products are shipped or delivered, depending on contract terms.

For multiple element arrangements, the total consideration for an arrangement is allocated among the separate elements in the arrangement based on a selling price hierarchy. The selling price hierarchy for a deliverable is based on: (1) vendor specific objective evidence (“VSOE”), if available; (2) third party evidence of selling price if VSOE is not available; or (3) an estimated selling price, if neither VSOE nor third party evidence is available. Estimated selling price is our best estimate of the selling price of an element in a transaction. The Company limits the amount of revenue recognized for delivered elements to the amount that is not contingent on the future delivery of products or services or other future performance obligations.

Leases

The Company accounts for leases in accordance with ASC 840, Leases, which requires leases to be classified as either operating or capital leases. In general, the Company classifies leases as capital leases when there is either a transfer of ownership at the end of the lease term, the lease contains a bargain purchase option, the lease term is seventy-five percent or more of the estimated economic life of the leased property or the minimum lease payments are ninety percent or more of the fair value at lease inception. Other leases are classified as operating leases.

Operating lease rent is recorded as an operating expense monthly. For capital leases, both an asset and liability are recorded at the inception of the lease based on the present value of lease payments. The asset is included with property and equipment on the condensed consolidated balance sheet and amortization is recorded on a straight-line basis over the term of the lease reported as a component of the individual costs and expenses as part of the condensed consolidated statements of operations and comprehensive loss. For the liability, the amount due within the next year is recorded as capital lease obligations and the amount due in more than a year is recorded as long-term capital lease obligation on the condensed consolidated balance sheet. Interest expense is recorded based on the implicit or explicit interest rate used in the lease and is included as non-operating interest expense on the condensed consolidated statements of operations and comprehensive loss.expenses.

Equity-Based Compensation


The Company awards stock optionsevaluates the recoverability of the carrying amount of its instruments whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable, and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instrumentsthis evaluation is performed at least annually. This evaluation is based on our estimate of future cash flows and the estimated fair value of such long-lived assets, and provides for impairment if such undiscounted cash flows or the instrument onestimated fair value are insufficient to recover the grant date,carrying amount of instruments. NaN impairment charges have been recorded as of June 30, 2021 and is recognized overDecember 31, 2020.

Long-lived Assets

Long-lived assets and certain identifiable intangibles to be held and used by the requisite service period on a straight-line basis overCompany are reviewed for impairment whenever events or changes in circumstances indicate that the vesting period for each tranche (an accelerated attribution method). For unvested consultant grants, the assumptions are updated at the endcarrying amount of each reporting period until the grant is vested.an asset may not be recoverable. The Company estimatescontinuously evaluates the recoverability of its long-lived assets based on estimated future cash flows from and the estimated fair value of stock option awards, including modifications of stock option awards, usingsuch long-lived assets, and provides for impairment if such undiscounted cash flows or the Black-Scholes option pricing model. This model derives theestimated fair value of stock options based on certain assumptions relatedare insufficient to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.

Volatility: The expected volatility is based onrecover the historical volatilitycarrying amount of the Company’s stock price over the most recent period commensurate with the expected term of the stock option award.long-lived asset.

Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award.



Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term.

Dividend yield: The dividend yield is estimated as zero as the Company has not paid dividends in the past and does not have any plans to pay any dividends in the foreseeable future.

The Company implemented ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting on January 1, 2017. Pursuant to this guidance, we made a policy election to account for forfeitures as they occur rather than on an estimated basis. For periods prior to the adoption of this ASU, the Company estimated the forfeiture rate of unvested awards based on the forfeitures in the previous twelve-month period. The rate was calculated separately for awards to the board of directors/executives and all other awards. Further information regarding this change is included in Note 14, Employee Equity-Based Compensation.

The Company also has an employee stock purchase program whereby eligible employees can elect payroll deductions that are subsequently used to purchase common stock at a discounted price. There is no compensation recorded for this program as (i) the purchase discount does not exceed the issuance costs that would have been incurred to raise a significant amount of capital by a public offering, (ii) substantially all employees that meet limited employment qualifications may participate on an equitable basis, and (iii) the plan does not incorporate option features that would require compensation to be recorded.

See Note 14, Employee Equity-Based Compensation for further information.

Cost of Sales

Cost of sales consists of raw materials, depreciation, direct labor and stock-based compensation expense, manufacturing overhead, facility costs and warranty costs.


Warranty Reserve


Instruments are typically sold with a one year limited warranty, while kits and accessories are typically sold with a sixty days limited warranty. Accordingly, a provision for the estimated cost of the limited warranty repair is recorded at the time revenue is recognized. Our estimated warranty provision is based on our estimate of future repair events and the related estimated cost of repairs. The Company periodically assesses the adequacy of the warranty reserve and adjusts the amount as necessary. The expense incurred for these provisions is included in cost of sales on the condensed consolidated statements of operations and comprehensive loss.


Warranty reserve activity for the three and six months ended June 30, 2021 and 2020 is as follows (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Beginning balance$184 $342 $232 $403 
Provisions12 (10)
Warranty cost incurred(27)(37)(53)(98)
Ending balance$169 $305 $169 $305 

Paycheck Protection Program (PPP) Loan

The PPP was established by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, through a significant expansion of the Small Business Administration (“SBA”) 7(a) loan program. On April 14, 2020, the Company entered into a promissory note (the “PPP Note”) evidencing an unsecured loan in the amount of $4.8 million.

The Company elected to account for the PPP Note in accordance with ASC 470, Debt, with interest accrued in accordance with the interest method under ASC 835-30, Imputation of Interest. The Company recognized the entire PPP Note amount as a liability on the balance sheet, with interest accrued and expensed over the term of the loan. The Company did not impute additional interest at a market rate because transactions where interest rates are prescribed by governmental agencies are excluded from the scope of ASC 835-30.

12


The PPP Note remains a liability until either of the following criteria are met:

the Company is legally released from being the primary obligor under the liability (i.e. the PPP Note is forgiven); or

the Company pays the lender and is relieved of its obligation for the liability

In January 2021, the Company submitted its application for forgiveness to the loan provider, and on July 15, 2021, the SBA informed the Company of its full forgiveness in the amount of $4.8 million. See Note 9, Long-Term Debt and Note 19, Subsequent Events for further detail regarding the PPP Note.

Convertible Notes

The Company accounts for convertible debt instruments that may be settled in cash or equity upon conversion, which includes the 2.50% Senior Convertible Notes due 2023 (the “Notes”), by separating the liability and equity components of the instruments in a manner that reflects our nonconvertible debt borrowing rate. The Company determined the carrying amount of the liability component of the Notes by using estimates and assumptions that market participants would use in pricing a debt instrument. These estimates and assumptions are judgmental in nature and could have a significant impact on the determination of the debt component, and the associated non-cash interest expense.

The equity component is treated as a discount on the liability component of the Notes, which is amortized over the term of the Notes using the effective interest rate method. Debt issuance costs related to the Notes are allocated to the liability and equity components of the Notes based on their relative values. Debt issuance costs allocated to the liability component are amortized over the life of the Notes as additional non-cash interest expense. Transaction costs allocated to equity are netted with the equity component of the convertible debt instrument in stockholders’ deficit.

Revenue Recognition

The Company recognizes revenue when control of the promised good or service is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Sales taxes are excluded from revenues.

The Company determines revenue recognition through the following steps:

Identification of the contract with a customer

Identification of the performance obligations in the contract

Determination of the transaction price

Allocation of the transaction price to the performance obligations

Recognition of revenue as we satisfy a performance obligation

Product revenue is derived from the sale or rental of our instruments and sales of related consumable products. When an instrument is sold, revenue is generally recognized upon installation of the unit consistent with contract terms, which do not include a right of return. When a consumable product is sold, revenue is generally recognized upon shipment. Invoices are generally issued when revenue is recognized and the term between invoicing and when payment is due is not typically significant.

Service revenue is derived from the sale of extended service agreements which are generally non-cancellable. This revenue is recognized on a straight-line basis over the contract term beginning on the effective date of the contract because the Company is standing ready to provide services. Invoices are generally issued annually and coincide with the beginning of individual service terms.

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Our contracts with customers may include multiple performance obligations. For such arrangements, we allocate revenue to each performance obligation based on its relative standalone selling price. We generally determine relative standalone selling prices based on the price charged to customers for each individual performance obligation.

Sales commissions earned by our sales force are considered incremental and recoverable costs of obtaining a contract with a customer. The Company has determined these costs would have an amortization period of less than one year and has elected to recognize them as an expense when incurred. Contract asset opening and closing balances were immaterial for the three and six months ended June 30, 2021.

Cost of Sales

Cost of sales includes cost of materials, direct labor, equity-based compensation, facility and other manufacturing overhead costs for consumable tests and instruments sold to customers. Cost of sales for instruments also includes depreciation on revenue generating instruments that have been placed with our customers under a reagent rental agreement. Cost of sales includes repair and maintenance cost for instruments covered by a service agreement or instruments covered by a reagent rental agreement. Cost of sales also includes warranty related expenses.

Shipping and Handling


Shipping and handling costs billed to customers are included as a component of revenue. The corresponding expense incurred with third party carriers is included as a component of sales, general and administrative costs on the condensed consolidated statements of operations and comprehensive loss.


Leases

The Company accounts for commercial leases in accordance with ASC 842, Leases. We determine if an arrangement is or contains a lease and the type of lease at inception. The Company classifies commercial leases as finance leases (lessee) or sales-type leases (lessor) when there is either a transfer of ownership of the underlying asset by the end of the lease term, the lease contains an option to purchase the asset that we are reasonably certain will be exercised, the lease term is for the major part of the remaining economic life of the asset, the present value of the lease payments and any residual value guarantee equals or substantially exceeds all the fair value of the asset, or the asset is of such a specialized nature that it will have no alternative use to the lessor at the end of the lease term. Payments contingent on future events (i.e. based on usage) are considered variable and excluded from lease payments for the purposes of classification and initial measurement. Several of our leases include options to renew or extend the term upon mutual agreement of the parties and others include one-year extensions exercisable by the lessee. None of our leases contain residual value guarantees, restrictions, or covenants.

To determine whether a contract contains a lease, the Company uses its judgment in assessing whether the lessor retains a material amount of economic benefit from an underlying asset, whether explicitly or implicitly identified, which party holds control over the direction and use of the asset, and whether any substantive substitution rights over the asset exist.

Lessee

Operating leases are included in right-of-use (“ROU”) assets and operating lease liabilities within our consolidated balance sheets. These assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and their related liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Typically, we use our incremental borrowing rate based on the information available at commencement in determining the present value of lease payments. We use the implicit rate when readily determinable. ROU assets are net of lease payments made and exclude lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term, which may include options to extend or terminate the lease when it is reasonably certain that we will exercise the option. As of June 30, 2021 and December 31, 2020, the Company was not a party to finance lease arrangements.

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Our operating leases consist primarily of leased office, factory, and laboratory space in the U.S. and office space in Europe, have between two and six-year terms, and typically contain penalizing, early-termination provisions.

Lessor

The Company leases instruments to customers under “reagent rental” agreements, whereby the customer agrees to purchase consumable products over a stated term, typically five years or less, for a volume-based price that includes an embedded rental for the instruments. When collectibility is probable, that amount is recognized as income at lease commencement for sales-type leases and as product is shipped, typically in a straight–line pattern, over the term for operating leases, which typically include a termination without cause or penalty provision given a short notice period.

Consideration is allocated between lease and non-lease components based on stand-alone selling price in accordance with ASC 606, Revenue from Contracts with Customers.

Net investment in sales-type leases are included within our condensed consolidated balance sheets as a component of other current assets and other non-current assets, which include the present value of lease payments not yet received and the present value of the residual asset, which are determined using the information available at commencement, including the lease term, estimated useful life, rate implicit in the lease, and expected fair value of the instrument.

Nonqualified Cash Deferral Plan

The Company's Cash Deferral Plan (the “Deferral Plan”), provides certain key employees, with an opportunity to defer the receipt of such participant's base salary. The Deferral Plan is intended to be a nonqualified deferred compensation plan that complies with the provisions of Section 409A of the Internal Revenue Code. All of the investments held in the Deferral Plan are equity securities consisting of mutual funds and recorded at fair value with changes in the investments' fair value recognized as earnings in the period they occur. The corresponding liability for the Deferral Plan is included in other non-current liabilities in the condensed consolidated balance sheet.

Equity-Based Compensation

The Company may award stock options, restricted stock units (“RSUs”), performance-based awards, and other equity-based instruments to its employees, directors and consultants. Compensation cost related to equity-based instruments is based on the fair value of the instrument on the grant date, and is recognized over the requisite service period on a straight-line basis over the vesting period for each tranche (an accelerated attribution method) except for performance-based awards. Performance-based awards vest based on the achievement of performance targets. Compensation costs associated with performance-based awards are recognized over the requisite service period based on probability of achievement. Performance-based awards require management to make assumptions regarding the likelihood of achieving performance targets.

The Company estimates the fair value of service based and performance based stock option awards, including modifications of stock option awards, using the Black-Scholes option pricing model. This model derives the fair value of stock options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rate and dividend yield.

Volatility: The expected volatility is based on the historical volatility of the Company's stock price over the most recent period commensurate with the expected term of the stock option award.

Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award.

Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term.

Dividend yield: The dividend yield is estimated as 0 as the Company has not paid dividends in the past and does not have any plans to pay any dividends in the foreseeable future.
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The Company records the fair value of RSUs or stock grants based on published closing market price on the day before the grant date. The Company accounts for forfeitures as they occur rather than on an estimated basis.

Deferred Tax

Deferred tax assets and liabilities are recorded for the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the accompanying balance sheets. The change in deferred tax assets and liabilities for the period represents the deferred tax provision or benefit for the period. Effects of changes in enacted tax laws in deferred tax assets and liabilities are reflected as an adjustment to the tax provision or benefit in the period of enactment.

The Company follows the provisions of ASC 740, Income Taxes, to account for any uncertainty in income taxes with respect to the accounting for all tax positions taken (or expected to be taken) on any income tax return. This guidance applies to all open tax periods in all tax jurisdictions in which the Company is required to file an income tax return. Under U.S. GAAP, in order to recognize an uncertain tax benefit, the taxpayer must be more likely than not certain of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more likely than not to be realized upon resolution of the position. Interest and penalties, if any, would be recorded within tax expense.

Foreign Currency Translation and Foreign Currency Transactions


The Company follows ASC 830, Foreign Currency Matters, which provides guidance on foreign currency transactions and translation of financial statements. Adjustments resulting from translating foreign functional currency financial statements into U.S. dollarsDollars are included in the foreign currency translation adjustment, within the condensed consolidated statementsa component of operations andaccumulated other comprehensive income loss.


The Company has assets and liabilities, primarilyincluding receivables and payables, which are denominated in currencies other than their functional currency. These balance sheet items are subject to re-measurement, the impact of which is recorded in foreign currency exchange gain orand loss, within the condensed consolidated statementsstatement of operations and comprehensive loss.




Loss Per Share

Basic loss per share includes no dilution and is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding for the period. Potentially dilutive common shares consist of shares issuable from stock options and unvested RSUs. Potentially dilutive common shares would also include common shares that would be outstanding if the Notes at the balance sheet date were converted and shares issuable in connection with a securities purchase agreement. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive.

Comprehensive Loss

In addition to net loss, comprehensive loss includes all changes in equity during a period, except those resulting from investments by and distributions to owners. The Company holds investments classified as debt securities available-for-sale and records the change in fair market value as a component of comprehensive loss. The Company also has adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars which is included as a component of comprehensive loss.

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NOTE 2. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS


Standards that were recently adopted

In May 2017,January 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2017-09, Compensation—Stock CompensationAccounting Standard Update (“ASU”) 2020-01, Investments-Equity Securities (Topic 718)Scope of Modification Accounting. This amendment clarifies when to account for a change to321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815), Clarifying the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classificationInteractions between Topic 321, Topic 323, and Topic 815 (a consensus of the award (as equity or liability) changes as a resultFASB Emerging Issues Task Force). ASU 2020-01 clarifies the interaction of the change in terms or conditions. It is effective prospectivelyaccounting for equity securities under Topic 321, the accounting for the annual period ending December 31, 2018equity method investments in Topic 323 and interim periods within that annual period. Early adoption is permitted. Historically, modificationsthe accounting for certain forward contracts and purchased options in Topic 815. The Company adopted ASU 2020-01 on January 1, 2021, which had no impact to our share-based awards is rare. As such, we do not expect the application of this standard to have a significant impact on our consolidated financial statements.


In March 2017,December 2019, the FASB issued ASU 2017-08, Receivable-Nonrefundable Fees and Other Costs2019-12, Income Taxes (Topic 310-20) Premium Amortization740); Simplifying the Accounting for Income Taxes. ASU 2019-12 reduces complexity in the accounting standard. The Company adopted ASU 2019-12 on Purchased Callable Debt Securities. This amendment shortens the amortization period for certain callable debt securities held at a premium. Specifically, the amendment requires premiumsJanuary 1, 2021, which had no impact to be amortized to the earliest call date. The amendments do not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted, including adoption in an interim period. If an entity early adopts in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The amendments should be applied on a modified retrospective basis, with a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. We are currently assessing the impact this will have on our consolidated financial statements andstatements. The Company maintains a full valuation allowance against its net deferred tax assets. The valuation allowance is based on management’s assessment that it is more likely than not that the timing of adoption.Company will not have taxable income in the foreseeable future.


Standards not yet adopted

In October 2016,August 2020, the FASB issued ASU 2016-16, Income Taxes (Topic 740) Intra-Entity Transfers2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40). ASU 2020-06 reduces the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of Assets Other Than Inventory. The update amends accounting guidance for intra-entity transfers of assets other than inventory to requireliabilities and equity. In addressing the recognition of income tax consequences when the transfer occurs. The update is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. A modified retrospective approach should be applied. We are currently assessing the impactcomplexity, this will have on our consolidated financial statements and the timing of adoption.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which amends the guidance on measuring credit lossesconvertible instruments and the guidance on financial assets (including trade accounts receivablethe derivatives scope exception for contracts in an entity’s own equity. This ASU will reduce the number of accounting models for convertible debt instruments and available for sale debt securities) held at amortized cost. Currently, an “incurred loss” methodology is used for recognizing credit losses, which delays recognition until it is probable a loss has been incurred. The amendment requires assets valued at amortized costconvertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current U.S. GAAP standards. Convertible instruments that continue to be presented atsubject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the net amount expected to be collected using an allowancehost contract, that meet the definition of a derivative, and that do not qualify for credit losses. Reversal of credit losses on available-for-salea scope exception from derivative accounting and (2) convertible debt securities will beinstruments issued with substantial premiums for which the premiums are recorded in the current period net income. The amendment will beas paid-in capital. This ASU is effective for us on January 1, 2020, with early adoption permitted. We do not anticipate this guidance will have a significant impact on our financial statements and plan to adopt on the effective date.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This replaces the existing standards relating to leases for both lessees and lessors. For lessees, the new standard requires most leases to be recorded on the balance sheet with expenses recognized much like the existing standard. For lessors, the new standard modifies the classification criteria and accounting for sales-type and direct financing leases and eliminates leveraged leases. For both lessees and lessors, the standard eliminates real estate-specific provisions, changes some of the presentation and disclosure requirements, and changes sale and leaseback criteria. The ASU is required for us on January 1, 2019,2022, with early adoption permitted. We are currently assessing the impact this will have on our consolidated financial statements.


In May 2014,2021, the FASB issued ASU 2014-09, Revenue from2021-04, Earnings Per Share (Topic 260), Debt - Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging - Contracts with Customers (Topic 606), whichin Entity’s Own Equity (Subtopic 815-40). ASU 2021-04 will supersede nearly all existing revenue recognitioncodify the final consensus reached by the Emerging Issues Task Force (EITF) on how an issuer should account for modifications made to equity-classified written call options (hereafter referred to as a warrant to purchase the issuer’s common stock). The guidance under U.S. GAAP. The standard’s core principle isin the ASU requires the issuer to treat a modification of an equity-classified warrant that a company will recognize revenue when it transfers promised goods or servicesdoes not cause the warrant to customers inbecome liability-classified as an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferral of the Effective Date, which deferred the effective date resulting inoriginal warrant for a new warrant. This guidance applies whether the modification is structured as an amendment to the terms and conditions of the warrant or as termination of the original warrant and issuance of a new warrant. This ASU is effective date for us of January 1, 2018. Early adoption is permitted. FASB has issued several other ASU’s which provide further guidance on Topic 606 and have the same effective date. The standard allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period


presented in the financial statements. We will implement ASU 2014-09 and all relevant subsequently issued ASU’s on Topic 606 concurrently on January 1, 2018, and2022, with early adoption permitted. We are currently evaluatingassessing the transition method. We are carefully evaluating our existing revenue recognition practices to determine the extent to which our contracts in the scope of the guidanceimpact this will be affected by the new requirements. The effects may include identifying performance obligations in existing arrangements, determining the transaction price and allocating the transaction price to each separate performance obligation. We will also establish practices to determine when a performance obligation has been satisfied, and recognize revenue in accordance with the new requirements. Given limited revenues have been recognized to date, we have not yet determined the effect of the standard on our future consolidated financial statements.

NOTE 3. FDA CLEARANCE

On February 23, 2017,statements, and believe it will not have an impact on the U.S. Food and Drug Administration (“FDA”) granted Accelerate’s de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples.

Due to various factors, the Company manufactured inventory in advance of regulatory approval (pre-launch inventory).

OnCompany's consolidated financial statements at January 1, 2017, the regulatory review process had progressed to a point that objective and persuasive evidence of approval was sufficiently probable, and a future economic benefit existed. On January 1, 2017, the Company started capitalizing pre-launch inventory. Additional information regarding inventory is included in Note 7, Inventory.2022.


Prior to January 1, 2017, all pre-launch inventory was not capitalized because a future economic benefit could not be asserted. Costs associated with the Company’s purchase of inventory were reported as research and development costs, or if the inventory was used in marketing evaluations, as sales, general and administrative costs on the consolidated statements of operations and comprehensive loss.



NOTE 3. CONCENTRATION OF CREDIT RISK

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable.

The Company has financial institutions for banking operations that hold 10% or more of the Company’s cash and cash equivalents. As of June 30, 2021, three of the Company's financial institutions held 61%, 16% and 13% of the Company’s cash and cash equivalents, respectively. As of December 31, 2020, three of the Company's financial institutions held 53% and 14% and 16% of the Company’s cash and cash equivalents, respectively.

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The Company grants credit to domestic and international customers. Exposure to losses on accounts receivable is principally dependent on each client's financial position. None of the Company's customers accounted for 10% or more of the net accounts receivable balance as of June 30, 2021 and December 31, 2020.

Customers who represented 10% or more of the Company’s total revenue for the three and six months ended June 30, 2021 and 2020 were as follows:


Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Company A*10 %**
* Less than 10% for the period indicated

NOTE 4. FAIR VALUE OF FINANCIAL INSTRUMENTS


The following tables represent the financial instruments measured at fair value on a recurring basis onin the financial statements of the Company and the valuation approach applied to each class of financial instruments at SeptemberJune 30, 2017,2021 and December 31, 2016.2020 (in thousands):


June 30, 2021
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
Assets:
Cash equivalents:
Money market funds$27,314 $$$27,314 
Corporate notes and bonds894 894 
Total cash equivalents27,314 894 28,208 
Equity investments:
Mutual funds593 593 
Total equity investments593 593 
Debt securities available-for-sale:
Certificates of deposit2,029 2,029 
U.S. Treasury securities375 375 
Commercial paper9,996 9,996 
Corporate notes and bonds11,258 11,258 
Total debt securities available-for-sale375 23,283 23,658 
Total assets measured at fair value$28,282 $24,177 $$52,459 

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September 30, 2017
(in thousands)December 31, 2020
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
TotalQuoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
Assets: 
 
 
 
Assets:
Cash and cash equivalents 
Cash equivalents:Cash equivalents:
Money market funds$19,610
$
$
$19,610
Money market funds$19,276 $$$19,276 
Commercial paper
1,800

1,800
Commercial paper885 885 
Total cash and cash equivalents19,610
1,800

21,410
Investments: 
Total cash equivalentsTotal cash equivalents19,276 885 20,161 
Equity investments:Equity investments:
Mutual fundsMutual funds357 357 
Total equity investmentsTotal equity investments357 357 
Debt securities available-for-sale:Debt securities available-for-sale:
Certificates of deposit
14,367

14,367
Certificates of deposit5,825 5,825 
US Treasury securities12,009


12,009
US Agency securities
7,485

7,485
U.S. Treasury securitiesU.S. Treasury securities5,923 5,923 
Commercial paper
10,456

10,456
Commercial paper10,604 10,604 
Asset-backed securities
5,024

5,024
Corporate notes and bonds
37,548

37,548
Corporate notes and bonds9,779 9,779 
Total investments12,009
74,880

86,889
Total debt securities available-for-saleTotal debt securities available-for-sale5,923 26,208 32,131 
Total assets measured at fair value$31,619
$76,680
$
$108,299
Total assets measured at fair value$25,556 $27,093 $$52,649 


 December 31, 2016
 (in thousands)
 Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
Significant
Other
Observable Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
Assets: 
 
 
 
Cash and cash equivalents:    
Money market funds$10,970
$
$
$10,970
Investments:    
Certificates of deposit
7,257

7,257
US Treasury securities8,544


8,544
US Agency securities
4,501

4,501
Asset-backed securities
5,557

5,557
Corporate notes and bonds
32,660

32,660
Total investments8,544
49,975

58,519
Total assets measured at fair value$19,514
$49,975
$
$69,489

Money market fundsHighly liquid investments with an original maturity of three months or less at time of purchase are included in cash and cash equivalents on the condensed consolidated balance sheet.


Level 1 assets are priced using quoted prices in active markets for identical assets which include money market funds, and U.S. Treasury securities and mutual funds as these specific assets are liquid.


Level 2 available-for-sale securities are priced using quoted market prices for similar instruments or nonbinding


market prices that are corroborated by observable market data. The Company uses inputs such as actual trade data, benchmark yields, broker/dealer quotes, and other similar data, which are obtained from quoted market prices, independent pricing vendors, or other sources, to determine the ultimate fair value of these assets and liabilities. The Company uses such pricing data as the primary input to make its assessments and determinations as to the ultimate valuation of its investment portfolio and has not made, during the periods presented, any material adjustments to such inputs. There were no transfers between levels during the nine months ended September 30, 2017.


NOTE 5. CONCENTRATION OF CREDIT RISK

Financial instruments that potentially subjectIn 2018, the Company issued the Notes, for total proceeds of $171.5 million, as described in Note 10, Convertible Notes. At June 30, 2021 and December 31, 2020, the fair value of the Notes were $112.7 million and $98.7 million, respectively. The fair value of the Notes is highly correlated to concentrationsthe Company’s stock price and as a result, significant changes to the Company’s stock price will have a significant impact on the calculated fair value. The fair value of credit risk consist primarily of cash equivalents, investments and accounts receivable including receivables from major customers.the Notes are classified as Level 2 within the fair value hierarchy. See Note 10, Convertible Notes for further detail on the Company’s convertible notes.


The Company’s main financial institution for banking operations held 76% and 57%Company's PPP Note along with its other long-term notes, cumulatively $5.3 million, approximate their fair value. The estimated fair value of the Company’s cash and cash equivalents as of September 30, 2017, and December 31, 2016, respectively.long-term debt represents a Level 3 measurement. See Note 9, Long-Term Debt for further detail on the Company's long-term debt.


19


NOTE 6.5. INVESTMENTS


The following tables summarize the Company’s debt securities available-for-sale investments at SeptemberJune 30, 2017,2021 and December 31, 2016:2020 (in thousands):


June 30, 2021
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$2,028 $$$2,029 
U.S. Treasury securities375 375 
Commercial paper9,993 9,996 
Corporate notes and bonds11,259 (2)11,258 
Total$23,655 $$(2)$23,658 
AVAILABLE-FOR-SALE INVESTMENTS
September 30, 2017
(in thousands)
 
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$14,367
$
$
$14,367
US Treasury securities12,035

(26)12,009
US Agency securities7,511

(26)7,485
Commercial paper10,456


10,456
Asset-backed securities5,023
1

5,024
Corporate notes and bonds37,577

(29)37,548
Total$86,969
$1
$(81)$86,889


December 31, 2020
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$5,820 $$$5,825 
U.S. Treasury securities5,908 15 5,923 
Commercial paper10,603 10,604 
Corporate notes and bonds9,779 (1)9,779 
Total$32,110 $22 $(1)$32,131 
AVAILABLE-FOR-SALE INVESTMENTS
December 31, 2016
(in thousands)
 Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$7,257
$
$
$7,257
US Treasury securities8,553
1
(10)8,544
US Agency securities4,514

(13)4,501
Asset-backed securities5,554
3

5,557
Corporate notes and bonds32,717
3
(60)32,660
Total$58,595
$7
$(83)$58,519


The following table summarizes the maturities of the Company’s debt securities available-for-sale securitiesinvestments at SeptemberJune 30, 2017,2021 and December 31, 2016:2020 (in thousands):



June 30, 2021December 31, 2020
Amortized
Cost
Fair ValueAmortized
Cost
Fair Value
Due in less than 1 year$23,655 $23,658 $32,110 $32,131 


AVAILABLE-FOR-SALE INVESTMENT MATURITIES
(in thousands)
 September 30, 2017December 31, 2016
 Amortized
Cost
Fair ValueAmortized
Cost
Fair Value
Due in less than 1 year$60,999
$60,974
$45,391
$45,344
Due in 1-5 years25,970
25,915
13,204
13,175
Total$86,969
$86,889
$58,595
$58,519

ProceedsThere were 0 proceeds from salesthe sale of marketabledebt securities available-for-sale (including principal paydowns), for each of the three months endedSeptember June 30, 20172021 and 2016 were $3.0 million and $7.7 million, respectively, and for the for the nine months endedSeptember 30, 2017 and 2016 were $9.5 million and $8.7 million, respectively.2020. The Company determines gains and losses of marketable securities based on specific identification of the securities sold. There were $6,000 of realized gains from sales of marketable securities for the three and nine months ended September 30, 2016, and no gross0 material realized gains or losses from sales of marketabledebt securities available-for-sale for the three and ninesix months ended SeptemberJune 30, 2017. The gross proceeds associated with the realized gains2021 and 2020. NaN material balances were reclassified out of accumulated other comprehensive income for the three and ninesix months ended SeptemberJune 30, 20162021 and 2020.

As of June 30, 2021, there were $7.2 million.no holdings of debt securities available-for-sale of any one issuer in an amount greater than 10%. As of June 30, 2021, and December 31, 2020 there were 0 material debt securities available-for-sale in a material unrealized loss position.
No other-than-temporary impairments
As of June 30, 2021, the Company carried $0.3 million of debt securities available-for-sale that were below the Company's minimum credit rating. These debt securities available-for-sale are not in an unrealized loss position and are not subject to credit risk. All other debt securities available-for-sale had a credit rating of A- or better as of June 30, 2021.

Equity securities are comprised of investments in mutual funds. The fair value of equity securities at June 30, 2021 and December 31, 2020 was $0.6 million and $0.4 million, respectively. There were 0 material unrealized gains or losses on equity securities recorded in income for each of the three and six months ended June 30, 2021 and 2020. These unrealized gains or losses are recorded as no material investment had a fair value that remained less than its costcomponent of other income
20


(expense), net. There were 0 realized gains or losses from equity securities for more than twelveeach of the three and six months asended June 30, 2021 and 2020.

NOTE 6. INVENTORY

Inventories consisted of Septemberthe following at June 30, 2017,2021 and there have been no other indicators of impairment. The Company does not intend to sell investments and it is more likely than not that we will not be required to sell investments before recovering the amortized cost.December 31, 2020 (in thousands):


Additional information regarding the fair value of our financial instruments is included in Note 4, Fair Value of Financial Instruments.
June 30,December 31,
20212020
Raw materials$5,140 $4,891 
Work in process2,147 1,942 
Finished goods2,285 2,383 
$9,572 $9,216 



NOTE 7. INVENTORYPROPERTY AND EQUIPMENT


Inventory is statedProperty and equipment consisted of the following at June 30, 2021 and December 31, 2020 (in thousands):

June 30,December 31,
20212020
Computer equipment$3,628 $3,608 
Technical equipment3,675 3,789 
Facilities3,691 3,693 
Instruments5,837 5,880 
Capital projects in progress37 
Total property and equipment$16,868 $16,970 
Accumulated depreciation(11,320)(10,835)
Property and equipment, net$5,548 $6,135 

Depreciation expense for the lesser of cost or net realizable value, with cost determined on the first-in-first-out method. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expensethree and spoilage are expensed as incurred,six months ended June 30, 2021 and not included in overhead subject to capitalization. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration. The components of inventories2020 were as follows (in thousands):


Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Depreciation expense$493 $637 $1,053 $1,246 

Gross assets under operating leases where the Company is the lessor at June 30, 2021 and December 31, 2020 were $3.6 million and $3.8 million, respectively. The underlying accumulated depreciation under operating leases where the Company is the lessor at June 30, 2021 and December 31, 2020 was $1.2 million and $1.1 million, respectively.

21
 September 30,December 31,
 20172016
Raw materials$4,607
$
Work in process429

Finished goods2,305

Inventory, net$7,341
$




NOTE 8. DEFERRED REVENUE AND REMAINING PERFORMANCE OBLIGATIONS


Deferred revenue consists of amounts received for products or services not yet delivered or earned. If we anticipate revenue will not be earned within the following twelve months, the amount is reported as other non-current liabilities. A summary of the balances as of June 30, 2021 and December 31, 2020 follows (in thousands):

June 30,December 31,
20212020
Products and services not yet delivered$282 $376 

We recognized $0.2 million and $0.3 million of revenues that were included in the beginning contract liabilities balances during the three and six months ended June 30, 2021, respectively, and $0.1 million and $0.2 million of revenues that were included in the beginning contract liabilities balances during the three and six months ended June 30, 2020, respectively. No material amount of revenue recognized during the period was from performance obligations satisfied in prior periods.

Transaction Price Allocated to Remaining Performance Obligations

As of June 30, 2021, $10.9 million of revenue is expected to be recognized from remaining performance obligations. This balance primarily relates to product shipments for reagents sold to customers under sales-type lease agreements. These agreements have between two and four year terms and revenue is recognized as product is shipped, typically on a straight-line basis. The remaining balance relates to executed service contracts that begin as warranty periods expire. These service contracts typically provide for four-year terms and revenue is recognized on a straight-line basis.

The Company elects not to disclose the value of unsatisfied performance obligations for (i) contracts with an expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed.

NOTE 9. LONG-TERM DEBT

As of June 30, 2021 and December 31, 2020, long-term debt consisted of the following (in thousands):

June 30,December 31,
20212020
PPP Loan - 1% interest$4,837 $4,812 
Other Loans - various interest420 400 
Total debt5,257 5,212 
Current portion of long-term debt1,452 553 
Long-term debt$3,805 $4,659 

The following presents maturities of future principal obligations of long-term debt as of June 30, 2021 (in thousands):

Remainder of 2021$549 
20221,675 
20231,291 
20241,304 
2025438 
Thereafter
Total$5,257 

22


Other notes payable

The Company entered into 3 loan agreements with 2 capital asset financing companies. Loan proceeds were $0.8 million, with interest rates ranging from 9.8% to 12.4% and maturities ranging from January 1, 2022 to September 2022. As of June 30, 2021, the current portion of long-term debt was $0.3 million and long-term debt was $0.1 million.

PPP Loan

On April 14, 2020, the Company entered into the PPP Note evidencing an unsecured loan in the amount of $4.8 million made to the Company under the PPP. The PPP was established under the CARES Act and is administered by the SBA.

On September 3, 2020 the Company's loan provider amended the PPP Note per the Paycheck Protection Program Flexibility Act (“PPP Flexibility Act”), which was enacted after the PPP Note was approved and funded. The PPP Flexibility Act amended the CARES Act to require that all PPP Note's made prior to June 5, 2020 be extended to a 5-year term. In accordance with this amendment the PPP Notes' original maturity date of April 14, 2022 was amended to April 14, 2025. The original terms of the loan required 18 monthly payments of principal and interest in the amount of $0.3 million starting November 14, 2020. The amended terms required 45 monthly payments of principal and interest in the amount of $0.1 million starting August 14, 2021. The PPP Note's interest rate was unchanged and bears an interest at a rate of 1% per annum.

The PPP Note could be prepaid by the Company at any time prior to maturity with no prepayment penalties. The proceeds from the PPP Note could only be used for payroll costs (including benefits), interest on mortgage obligations, rent, utilities and interest on certain other debt obligations.

The PPP Note contains customary events of default relating to, among other things, payment defaults, making materially false and misleading representations to the lender or breaching the terms of the PPP Note documents. The occurrence of an event of default could result in an increase in the interest rate to 18% per annum and provides the lender with customary remedies, including the right to require immediate payment of all amounts owed under the PPP Note.

Pursuant to the terms of the CARES Act and the PPP, the Company may apply to the Lender for forgiveness for the amount due on the Loan. The amount eligible for forgiveness is based on the amount of Loan proceeds used by the Company (during the 24-week period after the Lender makes the first disbursement of Loan proceeds) for the payment of certain covered costs, including payroll costs (including benefits), rent and utilities, subject to certain limitations and reductions in accordance with the CARES Act and the PPP.

During January 2021, the Company submitted its application for forgiveness to the Lender. On July 15, 2021, the SBA informed the Company of its full forgiveness for the entire Loan amount plus accrued interest, which was $4.8 million as of June 30, 2021. The SBA’s determination of loan forgiveness does not preclude further investigation by the SBA according to its rules and regulations. See Note 19, Subsequent Events for further detail on the status of the Company’s PPP Loan.

NOTE 10. CONVERTIBLE NOTES

On March 27, 2018, the Company issued $150.0 million aggregate principal amount of 2.50% Senior Convertible Notes due 2023. In connection with the offering of the Notes, the Company granted the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes on the same terms and conditions. On April 4, 2018, the option was partially exercised, which resulted in $21.5 million of additional proceeds, for total proceeds of $171.5 million. The Notes are the Company's senior unsecured obligations and mature on March 15, 2023 (the “Maturity Date”), unless earlier repurchased or converted into shares of common stock under certain circumstances described below. Upon conversion of the Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock, or a combination of cash and shares of common stock, at the Company’s election. The initial conversion rate of the Notes is 32.3428 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $30.92 per share of common stock, subject to adjustment. The Company pays interest on the Notes semi-annually in arrears on March 15 and September 15 of each year.

23


The $171.5 million of proceeds received from the issuance of the Notes were allocated between long-term debt (the “liability component”) of $116.6 million and contributed capital (the “equity component”) of $54.9 million. The fair value of the liability component was measured using rates determined for similar debt instruments without a conversion feature. The carrying amount of the equity component, representing the conversion option, was determined by deducting the fair value of the liability component from the aggregate face value of the Notes. The liability component will be accreted up to the face value of the Notes of $171.5 million, which will result in additional non-cash interest expense being recognized through the Maturity Date. The equity component will not be remeasured as long as it continues to meet the conditions for equity classification.

The Company incurred approximately $5.0 million of issuance costs related to the issuance of the Notes, of which $3.4 million and $1.6 million were recorded to long-term debt and contributed capital, respectively. The $3.4 million of issuance costs recorded as long-term debt on the condensed consolidated balance sheet are being amortized over the five-year contractual term of the Notes using the effective interest method. The effective interest rate on the Notes, including accretion of the Notes to par and debt issuance cost amortization, is 11.52%.

The Notes include customary terms and covenants, including certain events of default upon which the Notes may be due and payable immediately. Holders have the option to convert the Notes in multiples of $1,000 principal amount at any time prior to December 15, 2022, but only in the following circumstances:

if the Company’s stock price exceeds 130% of the conversion price for 20 of the last 30 trading days of any calendar quarter after June 30, 2018;

during the 5 business day period after any 5 consecutive trading day period in which the Notes’ trading price is less than 98% of the product of the common stock price times the conversion rate; or

the occurrence of certain corporate events, such as a change of control, merger or liquidation.

At any time on or after December 15, 2022, a holder may convert its Notes in multiples of $1,000 principal amount. Holders of the Notes who convert their Notes in connection with a make-whole fundamental change (as defined in the Indenture pursuant to which the Notes were issued) are, under certain circumstances, entitled to an increase in the conversion rate. In addition, in the event of a fundamental change or event of default prior to the Maturity Date, holders will, subject to certain conditions, have the right, at their option, to require the Company to repurchase for cash all or part of the Notes at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest up to, but excluding, the repurchase date.

The Notes at June 30, 2021 and December 31, 2020 consisted of the following (in thousands):

June 30,December 31,
20212020
Outstanding principal$171,500 $171,500 
Unamortized debt discount(22,800)(28,524)
Unamortized debt issuance(1,410)(1,765)
Net carrying amount of the liability component$147,290 $141,211 

Interest expense for the three and six months ended June 30, 2021 and 2020 were as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Contractual coupon interest$1,072 $1,072 $2,144 $2,144 
Amortization of the debt discount2,903 2,591 5,724 5,109 
Amortization of debt issuance costs180 160 354 316 
Total interest expense on convertible notes$4,155 $3,823 $8,222 $7,569 

As of June 30, 2021 and December 31, 2020, no Notes were convertible pursuant to their terms.

24


In connection with the Notes issuance, the Company entered into a prepaid forward stock repurchase transaction (“Prepaid Forward”) with a financial institution (“Forward Counterparty”). Pursuant to the Prepaid Forward, the Company used approximately $45.1 million of the net proceeds from its issuance of the Notes to fund the Prepaid Forward. The aggregate number of shares of the Company’s common stock underlying the Prepaid Forward was approximately 1,858,500. The expiration date for the Prepaid Forward is March 15, 2023, although it may be settled earlier in whole or in part. Upon settlement of the Prepaid Forward, at expiration or upon any early settlement, the Forward Counterparty will deliver to the Company the number of shares of common stock underlying the Prepaid Forward or the portion thereof being settled early. The shares purchased under the Prepaid Forward are treated as treasury stock and not outstanding for purposes of the calculation of basic and diluted earnings per share, but will remain outstanding for corporate law purposes, including for purposes of any future stockholders’ votes, until the Forward Counterparty delivers the shares underlying the Prepaid Forward to the Company. The Company’s Prepaid Forward hedge transaction exposes the Company to credit risk to the extent that its counterparty may be unable to meet the terms of the transaction. The Company mitigates this risk by limiting its counterparty to a major financial institution.

NOTE 8. PROPERTY AND EQUIPMENT11. EARNINGS PER SHARE


PropertyBasic net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average common shares outstanding during the period. Basic and equipmentdiluted net loss per share are recorded at cost and consistedthe same because all outstanding common stock equivalents have been excluded, as they are anti-dilutive due to the Company’s losses.

The following potentially issuable common shares were not included in the computation of diluted net loss per share because they would have an anti-dilutive effect for each of the followingthree and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Shares issuable upon the release of restricted stock units2,444 704 2,444 704 
Shares issuable upon exercise of stock options7,941 9,773 7,941 9,773 
10,385 10,477 10,385 10,477 

Potentially dilutive common shares would also include common shares that would be outstanding if Notes convertible at Septemberthe balance sheet date were converted. As discussed in Note 10, Convertible Notes, the Company issued $171.5 million of Notes due 2023. Upon conversion of the Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock, or a combination of cash and shares of common stock, at the Company’s election. The initial conversion rate of the Notes is 32.3428 shares of common stock per $1,000 principal amount of the Notes. As of June 30, 2017, and December 31, 2016.2021, 0 Notes were convertible pursuant to their terms. The number of shares issuable upon conversion of the Notes is 5.5 million shares.
PROPERTY AND EQUIPMENT
(in thousands)
 September 30,December 31,
 20172016
Computer equipment$2,865
$2,270
Technical equipment3,267
2,427
Facilities3,512
3,387
Instruments1,015

Capital projects in progress464
1,010
Total property and equipment$11,123
$9,094
Accumulated depreciation - other(6,433)(4,836)
Net property and equipment$4,690
$4,258

Depreciation expense (which includes amortization of capital lease assets) for the three months endedSeptember 30, 2017 and 2016 was $550,000 and $598,000, respectively, and for the nine months endedSeptember 30, 2017 and 2016 was $1.6 million and $1.7 million, respectively.
NOTE 9. LICENSE AGREEMENTS AND GRANTS

National Institute of Health Grant


In February 2015,connection with the National Institute of Health awarded Denver Health and the Company a five-year, $5.0 million grant to develop a fast and reliable identification and categorical susceptibility test carbepenem-resistant Enterobacteriaceae directly from whole blood. The cumulative sub-award amount is $885,000, under which the Company has invoiced a total of $740,000, which is recorded as an offset to research and development expenses. The amounts invoiced for the three months ended September 30, 2017 and 2016 were $180,000 and $8,000, respectively, and for the nine months ended September 30, 2017 and 2016 were $183,000 and $67,000, respectively.

Arizona Commerce Authority

In August 2012,Notes, the Company entered into a Grant Agreementprepaid forward stock repurchase transaction. The aggregate number of shares of the Company’s common stock underlying the Prepaid Forward was approximately 1,858,500. The shares purchased under the Prepaid Forward are treated as treasury stock and not outstanding for purposes of the calculation of basic and diluted earnings per share, but will remain outstanding for corporate law purposes, including for purposes of any future stockholders’ votes, until the Forward Counterparty delivers the shares underlying the Prepaid Forward to the Company.

As discussed in Note 17, Stockholders’ Equity, the Company entered into a securities purchase agreement (the “Grant“Securities Purchase Agreement”) with the Arizona Commerce Authority, an agency of the State of Arizona (the “Authority”), pursuant to which the Authority provided certain state and county sponsored incentives for the Company to relocate its corporate headquarters to, and expand its business within, the State of Arizona (the “Project”). Pursuant to the Grant Agreement, the Authority agreed to provide a total grantPurchasers (as defined in the amount of $1.0 million (the “Grant”Note 17, Stockholders’ Equity) for the useissuance and sale by the Company in the advancement of the Project. The Grant is payable out of an escrow account in four installments, upon the achievementaggregate of the following milestones:

Milestone 1 – Relocation of Company’s operations and corporate headquarters to Arizona and creation of 15 Qualified Jobs (as defined below).

Milestone 2 – Creation of 30 Qualified Jobs (including Qualified Jobs under Milestone 1).

Milestone 3 – Creation of 40 Qualified Jobs (including Qualified Jobs under Milestones 1 and 2).

Milestone 4 – Creation of 65 Qualified Jobs (including Qualified Jobs under Milestones 1, 2 and 3) and capital investment of at least $4.5 million.

For purposes of the Grant Agreement, a “Qualified Job” is a job that is permanent, full-time, new to Arizona, and for which the Company pays average (across all Qualified Jobs identified by the Company in its discretion) annual wages of at least $63,000 and offers health insurance benefits and pays at least 65% of the premiums associated with


such benefits. The amount of each installment payment will be determined in accordance with a formula specified in the Grant Agreement. The Grant Agreement also contains other customary provisions, including representations, warranties and covenants of both parties. As of September 30, 2017, the Company has collected all of the $1.0 million in milestones. The full amount is recorded in current deferred revenue and income until the economic development provisions of the grant have been satisfied in full, as there are “claw-back” provisions which would require repayment of certain amounts received if employment levels are not sustained during the term of the arrangement. Once the “claw-back” provisions expire in January 2018, we will recognize the grant as an offset to expense. Further details are included in Note 10, Deferred Revenue and Income.

Arizona R&D Refundable Tax Credit Program

The Company received a “Certificate of Qualification” from the Authority, which allowed the Company a partial refund of research and development investments. The amounts incurred under this program are recorded as an offset to research and development expenses, and for the nine months ended September 30, 2017 and 2016 were $0 and $1.2 million, respectively, and no amounts were incurred for three months ended September 30, 2017 and 2016, respectively. If the amount received for this program is later determined to be incorrect or invalid, the excess may need to be repaid.

NOTE 10. DEFERRED REVENUE AND INCOME

Deferred revenue consists of amounts received for products or services not yet delivered or earned. Deferred income consists of amounts received for commitments not yet fulfilled. If we anticipate that the revenue or income will not be earned within the following twelve months, the amount is reported as long-term deferred income. A summary of the balances as of September 30, 2017, and December 31, 2016, follows:
Deferred Revenue and Income
(in thousands)
 September 30,December 31,
 20172016
Products and services not yet delivered$81
$35
Arizona Commerce Authority grant1,000

Total current deferred revenue and income$1,081
$35
   
Arizona Commerce Authority grant
1,000
Total long-term deferred income$
$1,000

We have received $1.0 million in milestone payments from the Authority under the Grant Agreement described in Note 9, License Agreements and Grants. As of September 30, 2017, no such payments have been recognized in income, and we do not anticipate recognizing such payments as income until the “claw-back” provisions under the Grant Agreement expire in January 2018.



NOTE 11. STOCK PURCHASE

In April 2012, we entered into a Securities Purchase Agreement with Abeja Ventures, LLC pursuant to which the Company agreed, among other things, to issue a warrant to purchase4,166,663 shares of the Company’s common stock. Further detailsThe agreement contemplates that the closing of thisthe purchase and sale of the shares will occur in 3 approximately equal tranches on the dates as specified in the agreement areor such other dates as the parties may agree, with the first and second tranches having closed on February 19, 2021, and April 9, 2021, respectively. Shares from the third tranche were not included in our Annual Report on Form 10-Kthe computation of diluted net loss per share because they would have an anti-dilutive effect due to net losses.

25


NOTE 12. EMPLOYEE EQUITY-BASED COMPENSATION

The following table summarizes option activity under the Company's equity based compensation plans for the fiscal yearsix months ended December 31, 2016,June 30, 2021:

Number of SharesWeighted Average Exercise Price per Share
Options Outstanding January 1, 20218,045,461 $14.18 
Granted489,804 7.09 
Forfeited(179,244)13.73 
Exercised(337,393)3.62 
Expired(77,752)21.66 
Options Outstanding June 30, 20217,940,876 $14.13 

The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded for the three months ended June 30, 2021 and 2020:

Three Months Ended June 30,
20212020
Expected term (in years)5.795.83
Volatility65 %60 %
Expected dividends
Risk free interest rates1.10 %0.39 %
Weighted average fair value$4.09 $4.72 

The following table shows summary information for outstanding options and options that are exercisable (vested) as filedof June 30, 2021:

Options
Outstanding
Options
Exercisable
Number of options7,940,876 4,736,123 
Weighted average remaining contractual term (in years)6.325.03
Weighted average exercise price$14.13 $14.38 
Weighted average fair value$8.84 $9.14 
Aggregate intrinsic value (in thousands)$5,732 $4,410 

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The following table summarizes RSU and performance-based award activity for the six months ended June 30, 2021:

Number of SharesWeighted Average Grant Date Fair Value per Share
Outstanding January 1, 2021526,414 $11.17 
Granted2,663,948 11.31 
Forfeited(652,004)12.23 
Vested/released(94,417)10.22 
Outstanding June 30, 20212,443,941 $10.93 

The table below summarizes equity-based compensation expense for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Cost of sales$74 $59 $175 $130 
Research and development1,328 335 4,074 1,458 
Sales, general and administrative5,188 3,022 11,180 6,027 
$6,590 $3,416 $15,429 $7,615 

The table below summarizes share-based compensation cost capitalized to inventory or inventory transferred to property and equipment (also referred to as instruments) for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Cost capitalized to inventory$87 $28 $242 $138 

As of June 30, 2021, unrecognized equity-based compensation expense related to unvested stock options and unvested RSUs was $9.4 million and $19.2 million, respectively. This is expected to be recognized over the years 2021 through 2026.

Included in the above-noted stock options outstanding and stock compensation expense are performance-based stock options which vest only upon the achievement of certain targets. Performance-based stock options are generally granted at-the-money, contingently vest over a period of 1 to 2 years, depending on the nature of the performance goal, and have contractual lives of 10 years. These options were valued in the same manner as the time-based options, with the SEC on February 28, 2017. Asassumption that performance goals will be achieved. The inputs for expected volatility, expected dividends, and risk-free rate used in estimating those options’ fair value are the same as the time-based options issued under the Company's 2012 Omnibus Equity Incentive Plan. The expected term for performance-based stock options is 5 to 7 years. However, the Company only recognizes stock compensation expense to the extent that the targets are determined to be probable of December 31, 2016, there were warrantsbeing achieved, which triggers the vesting of the performance options.

In 2020, the Company granted 105,000 performance-based stock options. 45,000 performance-based stock options vested in prior periods due to purchase 415,871 shares unexercised.the performance obligations being achieved. During the ninesix months ended SeptemberJune 30, 2017, warrants2021, another 45,000 performance-based stock options vested due to purchase 370,307 sharesthe performance obligations being achieved. None of these options have been forfeited as of June 30, 2021.

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The table below summarizes share-based compensation cost in connection with performance-based stock options for the six months ended June 30, 2021 and 2020 (in thousands):

Six Months Ended June 30,
20212020
Performance-based stock option expense$230 $

Included in the above-noted RSU and performance-based award outstanding amounts are performance-based RSUs which vest only upon the achievement of certain targets. Performance-based RSUs contingently vest over a period of 1 to 3 years, depending on the nature of the performance goal, and have contractual lives of 10 years. These units were exercised at an exercisevalued in the same manner as other RSUs, based on the published closing market price on the day before the grant date. However, the Company only recognizes stock compensation expense to the extent that the targets are determined to be probable of $2.00 per share. Proceedsbeing achieved, which triggers the vesting of the performance options.

In 2020, the Company granted 364,338 performance-based RSUs. 81,000 performance-based RSUs were released in prior periods due to the performance obligations being achieved. 33,364 of these performance-based RSUs were forfeited due to the employees separating from the exerciseCompany, of which 9,369 were forfeited during the six months ended June 30, 2021. During the six months ended June 30, 2021, 84,000 of these performance-based RSUs were released due to the performance obligations being achieved. At June 30, 2021 165,974 of these performance-based RSUs were outstanding. None of these performance-based RSUs have been forfeited due to performance obligations not being achieved.

In 2021, the Company granted 233,472 performance-based RSUs. During the six months ended June 30, 2021, 3,255 of these performance-based RSUs were forfeited due to the employees separating from the Company. None of these performance-based RSU's have been released. At June 30, 2021 230,217 of these performance-based RSUs were outstanding. None of these performance-based RSUs have been forfeited due to performance obligations not being achieved.

The table below summarizes share-based compensation cost in connection with performance-based RSUs for the six months ended June 30, 2021, and 2020 (in thousands):
Six Months Ended June 30,
20212020
Performance-based RSU expense$818 $

NOTE 13. INCOME TAXES

For the six months ended June 30, 2021, the Company did 0t carry an income tax provision amount as the Company does not recognize tax benefits from current year tax losses in the U.S. and other foreign jurisdictions. The Company’s tax expense for the six months ended June 30, 2021 differs from the tax expense computed by applying the U.S. statutory tax rate to its year-to-date pre-tax loss of $45.9 million, as no tax benefits were recorded for tax losses generated in the U.S. and other foreign jurisdictions due to the valuation allowance. At June 30, 2021, the Company had deferred tax assets primarily related to U.S. federal and state tax loss carryforwards and a deferred tax liability related to amortization of the Notes. The Company provided a valuation allowance against its net deferred tax assets as future realization of such warrants totaling $741,000assets is not more likely than not to occur.

The Company accounts for uncertain tax positions pursuant to the recognition and measurement criteria under ASC 740, Income Taxes. For the three and six months ended June 30, 2021, we did not note any significant changes to our uncertain tax positions. We do not anticipate significant changes to uncertain tax positions within the next 12 months.

In December 2019, the FASB issued ASU No. 2019-12 Income Taxes (Topic 740) Simplifying the Accounting for Income Taxes. See Note 2, Recently Issued Accounting Pronouncements for additional information.

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In the first quarter of 2021, the Company was informed by the IRS that they would begin an examination of the Company’s 2018 tax year. Due to the early stage of the examination, management is unable to determine the impact the examination will have on the Company's tax position.

NOTE 15. LEASES

The following presents supplemental information related to our leases in which we are recordedthe lessee for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Cash paid for amounts included in lease liabilities
Operating cash flows from operating leases$154 $183 $308 $366 
ROU assets obtained in exchange for lease obligations
Operating leases$$$$17 
Lease Cost
Operating leases$261 $248 $559 $513 
Short-term leases$59 $$59 $35 

The weighted average remaining lease term on our operating leases is 4.0 years. The weighted average discount rate on those leases is 7%.

The following presents maturities of operating lease liabilities in which we are the lessee as common stockof June 30, 2021 (in thousands):

Remainder of 2021$403 
2022859 
2023968 
20241,055 
2025615 
Thereafter
Total lease payments3,900 
Less imputed interest(541)
$3,359 

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The net investment in sales-type leases, where we are the lessor, is a component of other current assets and contributed capitalother non-current assets in theour condensed consolidated balance sheet. As of June 30, 2021, the total net investment in these leases was $3.2 million. The remaining warrantsfollowing presents maturities of lease receivables under sales-type leases as of June 30, 2021 (in thousands):

Remainder of 2021$597 
20221,137 
2023765 
2024275 
202550 
Thereafter331 
Total undiscounted cash flows3,155 
Less imputed interest
Present value of lease payments$3,155 

NOTE 16. GEOGRAPHIC AND REVENUE DISAGGREGATION

The Company operates as 1 operating segment. Sales to purchase 45,564 shares expired unexercised oncustomers outside the U.S. represented 15% and 6% for the three months ended June 26, 2017.30, 2021 and 2020, respectively.


As of June 30, 2021 and December 31, 2020, balances due from foreign customers, in U.S. dollars, were $0.6 million and $0.3 million, respectively.

The following presents total net sales by geographic territory for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Domestic$2,386 $2,003 $4,532 $4,091 
Foreign412 122 784 377 
$2,798 $2,125 $5,316 $4,468 

The following presents total net sales by line of business for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020212020
Accelerate Pheno revenue$2,767 $2,093 $5,240 $4,398 
Other revenue31 32 76 70 
$2,798 $2,125 $5,316 $4,468 

The following presents total net sales by products and services for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2021202020202019
Products$2,483 $1,937 $4,700 $4,079 
Services315 188 616 389 
$2,798 $2,125 $5,316 $4,468 

30


Lease revenue included in net sales was $0.4 million and $0.3 million for the three months ended June 30, 2021 and 2020, respectively, and $0.8 million for the six months ended June 30, 2021 and 2020, which does not represent revenues recognized from contracts with customers.

NOTE 12. PUBLIC OFFERING17. STOCKHOLDERS’ EQUITY


Equity Sales Agreement

On May 9, 2017,28, 2021, the Company published a prospectus supplement underwritten by J.P. Morgan Securities LLC,entered into an Equity Sales Agreement (the “Sales Agreement”) with William Blair & Company, L.L.C., Piper Jaffray & Co. (“William Blair”) pursuant to which it may sell shares of the Company’s common stock having an aggregate offering price of up to $50 million, from time to time, through an “at-the-market” equity offering program under which William Blair will act as sales agent. Subject to the terms and BTIG, LLC ("Underwriters")conditions of the Sales Agreement, William Blair may sell shares by any method deemed to be an “at-the-market” offering 2.8 millionas defined in Rule 415 under the U.S. Securities Act of 1933, as amended (the “Securities Act"). The Company is not obligated to sell any shares under the Sales Agreement. William Blair is entitled to a commission of 3% of the aggregate gross proceeds from each sale of shares occurring pursuant to the Sales Agreement. During the three months ended June 30, 2021, the Company sold 92,497 shares of common stock under the Sales Agreement at a price per share of $8.80 resulting in aggregate gross proceeds of $0.8 million, which was recorded to contributed capital.

Securities Purchase Agreement

On December 24, 2020, the Company entered into the Securities Purchase Agreement with an optionJack W. Schuler, John Patience, Matthew Strobeck, Mark C. Miller, Thomas D. Brown and Jack Phillips, or entities affiliated with such persons (collectively, the “Purchasers”), for the Underwritersissuance and sale by the Company of an aggregate of 4,166,663 shares of the Company’s common stock (the “Shares”), to the Purchasers in an offering exempt from registration pursuant to Section 4(a)(2) of the Securities Act, and Rule 506 promulgated thereunder. Each of Jack W. Schuler, John Patience, Matthew Strobeck, Mark C. Miller, Thomas D. Brown and Jack Phillips is a member of the Company’s board of directors. Mr. Phillips also serves as the Company’s President and Chief Executive Officer. The entity affiliated with Jack W. Schuler that originally entered into the Securities Purchase Agreement subsequently entered into an assignment and assumption agreement whereby it assigned all of its rights and obligations as a Purchaser to three other entities that became Purchasers under the Securities Purchase Agreement. These three entities are related to Jack W. Schuler but are not affiliates of his.

Pursuant to the Securities Purchase Agreement, the Purchasers have agreed to purchase upthe Shares at a purchase price (determined in accordance with Nasdaq rules relating to 413,000 additional sharesthe “market value” of the Company’s common stock for a totalstock) of 3.2 million shares. The public offering price was $28.850$7.68 per share, and underwriting discounts and commissions were $1.731 per share for net proceeds of $27.119 per share.

The public offering was finalized and 2.8 million shares of common stock were deliveredwhich is equal to the purchasersconsolidated closing bid price reported by Nasdaq immediately preceding the time the Company entered into the Securities Purchase Agreement for an aggregate purchase price of approximately $32 million. The Securities Purchase Agreement contemplates that the closing of the purchase and sale of the Shares will occur in 3 approximately equal tranches on the dates specified in the agreement or around May 15, 2017. The Underwriters partially exercised their option to purchase an additional 335,000 shares,such other dates as the parties may agree, with the sale closingfirst and second tranches having closed on June 14, 2017,February 19, 2021 and the option as to the remaining shares expired June 15, 2017.April 9, 2021, respectively. Proceeds from the sales totaled $89.0closings of the first and second tranches under the Securities Purchase Agreement were recorded to contributed capital of $10.7 million less underwriting discounts, commissions and other costs of $5.8$21.3 million for net proceeds of $83.2 million. The net proceeds will be used for general corporate purposesthe three and to fund our commercialization efforts. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies, product candidates or other intellectual property, although we have no present commitments or agreements to do so. Accordingly, we will retain broad discretion over the use of these proceeds.six months ended June 30, 2021, respectively.


NOTE 13. EARNINGS PER SHARE

The financial statements show basic and diluted loss per share.

The Company’s net loss for the periods presented caused the inclusion of all outstanding warrants, restricted stock and options to purchase our common stock to be antidilutive. As of September 30, 2017, and December 31, 2016, there were common stock options, restricted stock units and warrants exercisable for 7,472,734 and 7,313,245 shares of common stock, respectively, which were not included in diluted loss per share as the effect was antidilutive.

NOTE 14. EMPLOYEE EQUITY-BASED COMPENSATION18. RELATED PARTY TRANSACTIONS


The following table summarizes option activity under all plans during the nine-month period ending September 30, 2017:Convertible notes

Stock Option Activity
 Number of SharesWeighted Average Exercise Price per Share
Options outstanding December 31, 20166,857,124
$7.72
Granted1,113,861
24.49
Forfeited(131,167)21.41
Exercised(384,812)9.93
Expired(6,422)24.45
Options Outstanding September 30, 20177,448,584
9.86

The table below summarizes the resulting weighted average inputs used to calculate the estimated fair value of options awarded during the periods shown below:



Black-Scholes Assumptions for Options Granted
 Three Months Ended
 September 30, 2017September 30, 2016
Expected term (in years)6.46
6.46
Volatility74%89%
Expected dividends

Risk free interest rates2.02%1.30%
Weighted average fair value$15.74
$15.40

The following table shows summary information for outstanding options and options that are exercisable (vested) as of September 30, 2017:

Stock Option Supplemental Information
 
Options
Outstanding
Options
Exercisable
Number of options7,448,584
5,214,464
Weighted average remaining contractual term (in years)6.32
5.40
Weighted average exercise price$9.86
$6.02
Weighted average fair value$7.31
$4.51
Aggregate intrinsic value (in thousands)$96,074
$86,005

The following table summarizes restricted stock unit and restricted stock award activity during the nine-month period ending September 30, 2017:

Restricted Stock Unit (RSU) and Restricted Stock Award (RSA) Activity
 Number of SharesWeighted Average Grant Date Fair Value per Share
RSUs & RSAs Outstanding December 31, 201640,250
$20.91
Granted1,911
22.40
Forfeited

Vested/released(18,011)21.07
RSUs & RSAs outstanding September 30, 201724,150
20.91

The expense recognized on the Company’s condensed consolidated statements of operations and comprehensive loss related to options is summarized below:

Equity-Based Compensation Expenses
(in thousands)
 Three Months EndedNine Months Ended
 September 30, 2017September 30, 2016September 30, 2017September 30, 2016
Cost of sales$22
$
$44
$
Research and development994
504
2,886
1,168
Sales, general and administrative2,504
2,166
8,040
5,423
Equity-based compensation expense$3,520
$2,670
$10,970
$6,591



As of September 30, 2017, $262,000 and $33,000 of equity-based compensation expense was a component of capitalized inventory and property and equipment respectively.

As of September 30, 2017, unrecognized equity-based compensation cost related to unvested stock options and unvested restricted stock units was $16.7 million and $216,000 respectively. This is expected to be recognized over the years 2017 through 2022.


As discussed in Note 1, we implemented ASU 2016-09, Compensation-Stock Compensation (Topic 718) Improvements10, Convertible Notes, the Company issued Notes in March 2018. As of June 30, 2021 and December 31, 2020 an entity controlled by one member of the Company's board of directors held an aggregate of $42.0 million of the Notes.

Securities Purchase Agreement

On December 24, 2020, the Company entered into the Securities Purchase Agreement with the Purchasers for the issuance and sale by the Company of an aggregate of 4,166,663 Shares to Employee Share-Based Payment Accounting on January 1, 2017.the Purchasers for an aggregate purchase price of approximately $32 million. The Purchasers are comprised of certain directors and officers of the Company, or entities affiliated or related to such persons. See Note 17, Stockholders’ Equity, for further information.

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NOTE 19. SUBSEQUENT EVENTS

The Company evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Pursuant to this guidance, we made a policy electionthe terms of the CARES Act and the PPP, the Company may apply to accountthe Lender for forfeitures as they occur rather than on an estimated basis and, therefore, equity based compensation expenseforgiveness for the three and nine months ended September 30, 2017 has been calculatedamount due on the Loan. The amount eligible for forgiveness is based on actual forfeitures in our condensed consolidated statements of operations and comprehensive loss, rather than our previous approach which was net of estimated forfeitures. Share-based compensation expense for the three and nine months ended September 30, 2016 is recorded net of estimated forfeitures, which were based on historical forfeitures and adjusted to reflect changes in facts and circumstances, if any. This change was accounted for using the modified retrospective transition method. This election resulted in a cumulative-effect adjustment which increased our accumulated deficit and additional paid-in capital by $655,000 for all outstanding awards as of January 1, 2017. We believe this election simplifies several aspects of the accounting for share-based payment transactions.

This new guidance requires that we record excess tax benefits and tax deficiencies related to the settlement of employee stock-based compensation to the income tax expense line item on our condensed consolidated statements of operations and comprehensive loss. The new guidance also states that previously unrecognized excess tax benefits should be recognized on a modified retrospective basis as of the beginning of the annual period of adoption. At January 1, 2017, we recorded approximately $1.5 million of additional deferred tax assets, which are fully offset by a valuation allowance. Accordingly, the adoption of ASU 2016-09 did not result in an adjustment to retained earnings for the cumulative effect of the tax benefit of the stock compensation.

The new guidance also requires excess tax benefits to be classified as an operating activity in the statement of cash flows rather than as a financing activity. Additionally, ASU 2016-09 requires that the minimum tax withholding paid on behalf of employees for share-based awards be classified as a financing activity in the statement of cash flows. Adoption of ASU 2016-09 did not result in any adjustments to prior period disclosures on the condensed consolidated statement of cash flows.

NOTE 15. INCOME TAXES

For the nine months ended September 30, 2017, the Company recorded a provision for income taxes of $220,000, which primarily related to a profitable foreign jurisdiction without any net operating loss carryforwards. The Company’s tax expense for the nine months ended September 30, 2017 differs from the tax expense computed by applying the U.S. statutory tax rate to its year-to-date pre-tax loss of $47.5 million as no tax benefits were recorded for tax losses generated in the U.S. and other foreign jurisdictions. At September 30, 2017, the Company had deferred tax assets primarily related to U.S. federal and state tax loss carryforwards. The Company provided a full valuation allowance against its deferred tax assets as future realization of such assets is not more likely than not to occur.

At September 30, 2017, the Company had gross unrecognized tax benefits of $1.1 million. The Company is not currently under examination by taxing authorities and does not believe the amount of unrecognized tax benefits will significantly increase or decrease overLoan proceeds used by the next 12 months.



NOTE 16. COMMITMENTS

Leases

The Company has entered into lease agreements, lease amendments, and lease extensions(during the last24-week period after the Lender makes the first disbursement of which expires in 2022. Total rent expense, including common area charges was $308,000 and $286,000Loan proceeds) for the three months ended September 30, 2017payment of certain covered costs, including payroll costs (including benefits), rent and 2016, respectively,utilities, subject to certain limitations and reductions in accordance with the CARES Act and the PPP.

During January 2021, the Company submitted its application for forgiveness to the Lender. On July 15, 2021, the SBA informed the Company of its full forgiveness for the nine months ended Septemberentire Loan amount plus accrued interest, which was $4.8 million as of June 30, 20172021. The SBA’s determination of loan forgiveness does not preclude further investigation by the SBA according to its rules and 2016 was $933,000 and $826,000, respectively. Future minimum lease payments under operating lease agreements are as follows:regulations.


Operating Lease Obligations
(in thousands)
Year ending December 31: 
2017$264
20181,022
2019180
202065
202130
Thereafter4
Total operating lease obligations$1,565

Clinical Trial Agreements

TheWith approval of the Company's application for forgiveness the Company has entered into master agreements with clinical trial sites in which we typically pay a set amount for start-up costs and then pay for work performed. These agreements typically indemnifywill record income from the clinical trial sites from any and all losses arising from third party claimsextinguishment as a resultgain recorded to other income (expense), net in the third quarter of 2021. See Note 9, Long-Term Debt for further detail on the Company’s negligence, willful misconduct or misrepresentation. The Company incurred clinical trial expense of $0 and $354,000 for the three months ended September 30, 2017 and 2016, respectively, and $27,000 and $1.8 million for the nine months ended September 30, 2017 and 2016, respectively. The expense incurred as part of the clinical trial is included in research and development on the condensed consolidated statements of operations and comprehensive loss.PPP Loan.


Legal Matters
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On March 19, 2015, a putative securities class action lawsuit was filed against Accelerate Diagnostics, Inc., Lawrence Mehren, and Steve Reichling, Rapp v. Accelerate Diagnostics, Inc., et al., U.S. District Court, District of Arizona, 2:2015-cv-00504. The complaint alleges that we violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, by making false or misleading statements about our Accelerate Pheno™ system, formerly called the BACcel System. Plaintiff purports to bring the action on behalf of a class of persons who purchased or otherwise acquired our stock between March 7, 2014, and February 17, 2015. On June 9, 2015, Julia Chang was appointed Lead Plaintiff of the purported class. On June 23, 2015, Plaintiff filed an amended complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, by making false or misleading statements or omissions about our ID/AST System and by allegedly employing schemes to defraud. Plaintiff sought certification of the action as a class action, compensatory damages for the class in an unspecified amount, legal fees and costs, and such other relief as the court may order. Defendants moved to dismiss the amended complaint on July 21, 2015. The Court granted the motion and dismissed the case with prejudice on January 28, 2016. On February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). On September 13, 2017, Plaintiff voluntarily dismissed the appeal and the case has been dismissed with prejudice.



NOTE 17. SEGMENTS

The Company operates as one operating segment. Operating segments are defined as components of an enterprise for which separate financial information is evaluated regularly by the chief operating decision maker, who is the chief executive officer, in deciding how to allocate resources and assessing performance. The Company’s business operates in one operating segment because the Company’s chief operating decision maker evaluates the Company’s financial information and resources and assesses the performance of these resources on a consolidated basis. Since the Company operates in one operating segment, all required financial segment information can be found in the consolidated financial statements.

NOTE 18. RELATED PARTY TRANSACTIONS

In June 2016, the Company recorded a net amount of $866,000 related to the recovery of short-swing profits under Section 16(b) of the Securities Exchange Act of 1934, as amended.  The Company recognized these related party proceeds as an increase to contributed capital on the condensed consolidated balance sheet.


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


Introductory Note


Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q (this “Form 10-Q”) to the “Company,” “Accelerate,” “we," “us” or “our” are references to the combined business of Accelerate Diagnostics, Inc. The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) summarizes the significant factors affecting our results of operations, liquidity, capital resources and contractual obligations. The following discussion and analysis should be read in conjunction with the Company’s unaudited condensed consolidated financial statements and related notes included elsewhere herein.



All amounts in the MD&A have been rounded to the nearest thousand unless otherwise indicated.

Forward-Looking Statements


This Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as “may,” “will,” “expect,” “anticipate,” “estimate,” or “continue,” or variations thereon or comparable terminology, include but are not limited to, statements about the plans and objectives of management for future operations, including plans and objectives relating to the products and future economic performance of the Company.Company; projections of our future financial performance and demand for our products; the anticipated impacts from the COVID-19 pandemic on the Company, including to our business, results of operations, cash flows and financial position, as well as our future responses to the COVID-19 pandemic; and our plans or expectations relating to our agreement with Ascend Diagnostics Ltd. (“Ascend”). In addition, all statements other than statements of historical facts that address activities, events, or developments the Company expects, believes, or anticipates will or may occur in the future, and other such matters, are forward-looking statements.


Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. There can be no assurances that results described in forward-looking statements will be achieved, and actual results could differ materially from those suggested by the forward-looking statements. The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties.uncertainties, including the duration and severity of the ongoing COVID-19 pandemic, including any new variants that may become predominant, and its ultimate effect on our business, results of operations, cash flows and financial position, as well as our ability (or inability) to execute on our plans to respond to the COVID-19 pandemic. Other important factors that could cause our actual results to differ materially from those in our forward-looking statements include those discussed herein, and in other reports filed with the U.S. Securities and Exchange Commission (the “SEC”) including but not limited to the risks in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, and in the Company's subsequent filings with the SEC. These forward-looking statements are also based on assumptions that the Company will retain key management personnel, the Company will be successful in the commercialization of the Accelerate Pheno™Pheno® system, the Company will obtain sufficient capital to commercialize the Accelerate Pheno™Pheno system and continue development of complementary products, the Company will be able to protect its intellectual property, the Company’s ability to respond to technological change, that the Company will accurately anticipate market demand for the Company’s products and that there will be no material adverse change in the Company’s operations or business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Although the Company believes that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the results contemplated in forward-looking statements will be realized. Any forward-looking statements made by us in this Form 10-Q speak only as of the date on which they are made. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) summarizes the significant factors affecting our results of operations, liquidity, capital resources and
33




contractual obligations. The following discussion and analysis should be read in conjunction with the Company’s unaudited condensed consolidated financial statements and related notes included elsewhere herein. Certain information contained in the discussion and analysis set forth below and elsewhere in this report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. The Company’s future operating results may be affected by various trends and factors which are beyond the Company’s control. These include, among other factors, general public perception of issues and solutions, and other uncertain business conditions that may affect the Company’s business. The Company cautions the reader that a number of important factors discussed herein, and in other reports filed with the SEC including but not limited to the risks in the section entitled “Risk Factors” in its Annual Report on Form 10-K for the period ended December 31, 2016, could affect the Company’s actual results and cause actual results to differ materially from those discussed in forward-looking statements.

Our MD&A is composed of the following sections: Overview, Changes in Results of Operations, Capital Resources and Liquidity and Off-Balance Sheet Arrangements. All amounts have been rounded to the nearest thousand unless otherwise indicated.

Overview


Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions that improve patient outcomes and lower healthcare costs through the rapid diagnosis of serious infections. Microbiology laboratories are in need of new tools to address what the U.S. Centers for Disease Control and Prevention (the “CDC”) calls one of the most serious healthcare threats of our time, antibiotic resistance. A significant contributing factor to the rise of resistance is the overuse and misuse of antibiotics, which is exacerbated by a lack of timely diagnostic results. The delay of theseidentification and antibiotic susceptibility results is often due to the reliance by microbiology laboratories on traditional culture-based tests that often take two to three days to complete. Our technology platform is builtintended to address these challenges by delivering significantly faster and accurate testing of infectious pathogens in various patient sample types.


Since 2004, we have focused our efforts on research into and the development of an innovative rapid diagnostic platform,Our first system to address these challenges is the Accelerate Pheno™ system, intendedPheno® system. The Accelerate PhenoTest® BC Kit, which is the first test kit for the rapidsystem, is indicated as an aid, in conjunction with other clinical and laboratory findings, in the diagnosis of infectious pathogens. Our goal is to reduce the failure rate of initial antibiotic drug therapy by shortening lab turnaround time to hours rather than the two to three days now required to deliver identificationbacteremia and susceptibility results.

The Accelerate Pheno™ system utilizes genotypic technology to identify, or “ID,” infectious pathogens and phenotypic technology to conduct antibiotic susceptibility testing, or “AST,” which determines whether live bacterial or fungal cells are resistant or susceptible to a particular antimicrobial agent. The Accelerate PhenoTest™ BC Kit provides ID and AST results for patients suspected of bacteremia or fungemia, both life-threatening conditions with high morbidity and mortality risk. The Accelerate PhenoTest™ BC Kit isdevice provides identification (“ID”) results followed by antibiotic susceptibility testing (“AST”) for certain pathogenic bacteria commonly associated with or causing bacteremia. This test kit utilizes genotypic technology to identify infectious pathogens and phenotypic technology to conduct AST, which determines whether live bacterial cells are resistant or susceptible to a highly multiplexed panel targeting over 80%particular antimicrobial. This information can be used by physicians to rapidly modify antibiotic therapy to lessen adverse events, improve clinical outcomes, and help preserve the useful life of the routine and significant pathogens causing blood stream infections and over 90% of the antibiotics useful in treating those pathogens.antibiotics.


On June 30, 2015, we declared our conformity to the European In Vitro Diagnostic Directive 98/79 79/EC and applied a CE Mark to the Accelerate Pheno™Pheno system and the Accelerate PhenoTest™PhenoTest BC Kit for in vitro diagnostic use. On February 23, 2017, the FDAU.S. Food and Drug Administration (“FDA”) granted our de novo classification request to market our Accelerate Pheno™Pheno system and Accelerate PhenoTest™PhenoTest BC KitKit.

In 2017, we began selling the Accelerate Pheno system in hospitals in the United States. TheStates, Europe, and the Middle East. Consistent with our “razor” / “razor-blade” business model, revenues to date have principally been generated from the sale or leasing of the instruments and the sale of single use consumable test kits.

In 2019 and 2020, based upon our initial experience selling and implementing the Accelerate PhenoTest™Pheno system, we implemented initiatives to improve and refine our commercial execution and to re-engineer our product implementation processes. Improving our commercial and implementation capabilities remains an emphasis going forward, along with geographic expansion and product innovation.

On July 29, 2020, we signed an exclusive product supply and collaboration agreement with Ascend to commercialize a benchtop MALDI identification platform to complement the Company's expanded product offering plans. We continue our analytical and market evaluations of the Ascend benchtop MALDI identification platform. We have limited experience implementing third-party product commercialization agreements. There are, therefore, uncertainties regarding market demand, market acceptance, supply constraints, FDA authorization, ramp up expenditures, and other factors impacting market penetration.

On July 7, 2021, we announced the launch of a new configuration of our PhenoTest BC kit includes 140 assaysin the United States providing AST without ID. On August 3, 2021, we announced that this new AST only configuration had been CE marked for use in Europe. We believe this new AST only configuration may be attractive to prospective customers who already have a rapid ID system but who still need fast susceptibility results to support getting patients on an optimal antibiotic therapy as soon as possible.

COVID-19 Update

In late 2019, a novel strain of coronavirus (COVID-19) was reported to have surfaced in Wuhan, China, which has since spread globally. In March 2020, the World Health Organization declared COVID-19 a global pandemic. Further, the COVID-19 outbreak has resulted in government authorities around the world implementing numerous measures to try to reduce the spread of COVID-19, such as travel bans and restrictions, quarantines, shelter-in-place, stay-at-home or total lock-down (or similar) orders and business limitations and shutdowns. For example, the State of Arizona has implemented several orders promoting physical distancing, limiting certain activities, and restricting the operations of certain retail businesses. More recently, many news agencies have reported the spread of new variants of COVID-19, such as the Delta variant. The spread of these new strains are
34


causing many government authorities to reimplement the aforementioned measures to try to reduce the spread that had become less prevalent.

The COVID-19 pandemic and these measures have caused, and are continuing to cause, business slowdowns or shutdowns in affected areas, both identificationregionally and susceptibility testing,worldwide, which have significantly impacted our business and results of operations, starting in the first quarter of 2020. For example, this included diminished access to our customers, including hospitals, which 116has severely limited our ability to sell and, to a lesser degree, implement the Accelerate Pheno systems. Our commercial access to customers has improved in some regions, with access in other regions remaining limited. In addition, in certain months with high rates of COVID-19 hospitalization our Accelerate PhenoTest BC kit orders declined as many hospitals curtailed elective surgeries to respond to COVID-19. For the three months ended June 2021, our Accelerate PhenoTest BC kit orders were clearedat normal levels after the higher levels of COVID-19 hospitalization contributed to irregular ordering patterns, but could decline again if surges in COVID-19 cases cause hospitals to again reduce or prohibit elective surgeries. The emergence of the significantly more contagious Delta variant of COVID-19 in the United States and in EMEA and the prevalence of breakthrough cases of infection among fully vaccinated people adds additional uncertainty regarding our access to our customers and prospects, demand for our products, and ability to implement our products.

The reduced sales and implementations caused by the FDACOVID-19 pandemic lowered our realized and 24 assaysexpected revenue growth for 2020 and 2021.

As a medical device company, we have not experienced any disruptions to our ability to manufacture our products at our Tucson, Arizona headquarters under the various State of Arizona executive orders relating to the COVID-19 pandemic because we were classified as an essential service. We currently expect that, should future orders be issued, we would be able to sustain our essential operations. Our third-party manufacturing supply chain for Accelerate Pheno systems and consumable test kits remains stable. However, like many industries experiencing inflationary pressures in raw materials, the direct costs to manufacture our products are availableincreasing and delivery schedules elongating. Our ability to pass increased material costs to many of our customers is limited because of long-term sales agreements with limits on price increases. Accordingly, we are closely monitoring the ability of all our suppliers to provide us with necessary materials and services at reasonable costs.

Additionally, the Company received loan proceeds of approximately $4.8 million under the Paycheck Protection Program established under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act.During January 2021, the Company submitted its application for forgiveness to the loan provider, and on July 15, 2021, the Small Business Administration (“SBA”) informed the Company of its full forgiveness in a Research Use Only modethe amount of $4.8 million.For additional information about the loan, refer to Part I, Item 1, Note 9, Long-Term Debt and Note 19, Subsequent Events in this Form 10-Q.

We continue to monitor the evolving impacts to our business caused by the COVID-19 pandemic, including the significantly more contagious COVID-19 Delta variant. We may take further actions required by governmental authorities or that we determine are prudent to support the well-being of our employees, customers, suppliers, business partners and others. The degree to which the COVID-19 pandemic ultimately impacts our business, results of operations, cash flows and financial position will depend on future developments, which are highly uncertain, continuously evolving and cannot be predicted. This includes, but is not limited to, the duration and spread of the software.pandemic, its severity, the actions to contain the virus or treat its impact, the level and effectiveness of vaccinations, vaccination hesitancy impeding herd immunity, the emergence of new COVID-19 variants, such as the Delta variant, the financial impact of COVID-19 on hospitals, including their budget priorities, and how quickly and to what extent normal economic and operating conditions can resume.


Accordingly, our current results and financial condition discussed herein may not be indicative of future operating results and trends. Refer to the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, for additional risks we face due to the COVID-19 pandemic.

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Changes in Results of Operations: Three and ninesix months ended SeptemberJune 30, 20172021, compared to three and ninesix months ended SeptemberJune 30, 20162020


The Company has provided enhanced information in a tabular format which presents some of the captions presented on the statement of operations, less non-cash equity-based compensation expense. These figures are reconciled to the statement of operations and are intended to add additional clarity on the operating performance of the business. The Company believes providing such figures less non-cash equity-based compensation expense provides helpful information for investors in understanding and evaluating our operating results in the same manner as our management and our board of directors.
 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Net sales$828
$24
$804
3,350% $2,058
$207
$1,851
894%


Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Net sales$2,798 $2,125 $673 32 %$5,316 $4,468 $848 19 %



For the three and ninesix months ended SeptemberJune 30, 2017,2021, total revenues increased as compared to the three and six months ended June 30, 2020 primarily due to increased sales of Accelerate Pheno™ systemsPhenoTest BC Kits and instruments. Accelerate's revenue has increased due to an increase in Accelerate PhenoTest™PhenoTest BC kits.Kit revenue generated by a growing installed base.


Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Cost of sales$1,745 $1,171 $574 49 %$3,365 $2,459 $906 37 %
Non-cash equity-based compensation as a component of cost of sales74 59 15 25 %175 130 45 35 %
Cost of sales less non-cash equity-based compensation$1,671 $1,112 $559 50 %$3,190 $2,329 $861 37 %
 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Cost of sales$191
$
$191
100% $352
$
$352
100%
Gross Profit$637
$24
$613
2,554% $1,706
$207
$1,499
724%


For the three and ninesix months ended SeptemberJune 30, 2017,2021, cost of sales increased as compared to the three and six months ended June 30, 2020 as a result of higher Accelerate PhenoTest BC Kit sales, increases to our cost of manufacturing, and other factors.

Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Gross profit$1,053 $954 $99 10 %$1,951 $2,009 $(58)(3)%
Non-cash equity-based compensation as a component of gross profit74 59 15 25 %175 130 45 35 %
Gross profit less non-cash equity-based compensation$1,127 $1,013 $114 11 %$2,126 $2,139 $(13)(1)%

For the three months ended June 30, 2021, gross profit increased as a result of the Company capitalizing inventory in connection with the FDA granting Accelerate’s de novo requestcompared to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit.

Inventory without a cost basis was sold to customers during the three and nine months ended SeptemberJune 30, 2017.2020. This inventoryincrease was comprisedprimarily due to an increase in sales of pre-launch inventory previously not capitalized,Accelerate PhenoTest BC revenue as our installed base for our instruments grew compared to the prior year period. The increase was partially offset by increases in costs to manufacture consumables due to pandemic-related inflationary factors and expenseda decrease in a previousour average unit sales price period over period. Cost of sales associated with this inventory duringGross profit less non-cash equity based compensation increased for the three and nine months ended SeptemberJune 30, 2017, would have been2021 compared to the three months ended June 30, 2020, which was partially offset by an additional $244,000increase in non-cash equity-based compensation expense.

For the six months ended June 30, 2021, gross profit decreased as compared to the six months ended June 30, 2020. The decrease was primarily due to increases in the costs to manufacture consumables due to pandemic-related inflationary factors and $611,000, respectively.

a decrease in our average unit sales price period over period. This decrease was partially offset by an increase in sales of Accelerate PhenoTest BC revenue as our installed base for
36


 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Research and development$6,351
$7,874
$(1,523)(19)% $16,166
$23,974
$(7,808)(33)%
our instruments grew compared to the prior year period. Gross profit less non-cash equity based compensation decreased for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 due to an increase in non-cash equity-based compensation expense.


Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Research and development$5,733 $5,347 $386 %$12,629 $11,189 $1,440 13 %
Non-cash equity-based compensation as a component of research and development1,328 335 993 296 %4,074 1,458 2,616 179 %
Research and development less non-cash equity-based compensation$4,405 $5,012 $(607)(12)%$8,555 $9,731 $(1,176)(12)%

Research and development expenses for the three and ninesix months ended SeptemberJune 30, 2017,2021 increased compared to the three and six months ended June 30, 2020 primarily due to increases in non-cash equity-based compensation expense resulting from an increased number of RSUs granted and performance based stock awards becoming probable or achieved, compared to the prior year periods. For the three and six months ended June 30, 2021, research and development expenses less non-cash equity-based compensation decreased due to improved internal efficiencies and reductions in external study fees compared to the prior year periods.

Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Sales, general and administrative$12,910 $11,332 $1,578 14 %$26,938 $24,275 $2,663 11 %
Non-cash equity-based compensation as a component of sales, general and administrative5,188 3,022 2,166 72 %11,180 6,027 5,153 85 %
Sales, general and administrative less non-cash equity-based compensation$7,722 $8,310 $(588)(7)%$15,758 $18,248 $(2,490)(14)%

Sales, general and administrative expense for the three and six months ended June 30, 2021 increased as compared to the same periods in the prior year as a result of clinical trial expenses not recurring in the current periods. Additionally, on January 1, 2017, the regulatory review process had progressed to a point that objectivethree and persuasive evidence of approval was sufficiently probable, and a future economic benefit existed for the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit. As a result, the Company started capitalizing pre-launch inventory for the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit on January 1, 2017. Prior to January 1, 2017, all pre-launch inventory was not capitalized, because a future economic benefit couldn’t be asserted.

Pre-launch inventory not capitalized in accordance with U.S. GAAP, which included instruments and consumables charged to research and development were $225,000 and $795,000 for the threesix months ended SeptemberJune 30, 2017 and 2016, respectively, and $376,000 and $3.9 million for the nine months ended September 30, 2017 and 2016, respectively.

Research and development expenses include non-cash equity-based compensation of $1.0 million and $504,000 for the three months ended September 30, 2017 and 2016, respectively, and $2.9 million and $1.2 million for the nine months ended September 30, 2017 and 2016, respectively. The increase2020 primarily due to increases in non-cash equity-based compensation was primarily driven byexpense resulting from an increase in theincreased number of employeesrestricted stock units granted and performance based stock option grants.

 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Sales, general and administrative$11,601
$9,566
$2,035
21% $33,589
$26,710
$6,879
26%



Sales,awards becoming probable or achieved, compared to the prior year periods. For the three and six months ended June 30, 2021, sales, general and administrative expenses for the three and nine months ended September 30, 2017, increased due to an increase in salaries and related expenses as we ramp up our sales and marketing operations globally.

Pre-launch inventory not capitalized in accordance with U.S. GAAP, which included instruments and consumables charged to sales, general and administrative expenses were $11,000 and $1.2 million for the three months ended September 30, 2017 and 2016, respectively, and $40,000 and $2.5 million for the nine months ended September 30, 2017 and 2016, respectively.

Sales, general and administrative expenses includeless non-cash equity-based compensation of $2.5 milliondecreased due to lower ordinary compensation, travel, trade shows and $2.2 million forinstrument demonstration expenses compared to the three months ended September 30, 2017 and 2016, respectively, and $8.0 million and $5.4 million for the nine months ended September 30, 2017 and 2016, respectively. The increase in non-cash equity-based compensation was primarily driven by an increase in the number of employees and stock option grants.prior year periods.


Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Loss from operations$(17,590)$(15,725)$(1,865)12 %$(37,616)$(33,455)$(4,161)12 %
Non-cash equity-based compensation as a component of loss from operations6,590 3,416 $3,174 93 %15,429 7,615 7,814 103 %
Loss from operations less non-cash equity-based compensation$(11,000)$(12,309)$1,309 (11)%$(22,187)$(25,840)$3,653 (14)%

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 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Loss from operations$(17,315)$(17,416)$101
(1)% $(48,049)$(50,477)$2,428
(5)%


For the three and ninesix months end Septemberended June 30, 2017,2021, our loss from operations decreasedincreased as a result ofcompared to the Company capitalizing inventory in connection with the FDA granting Accelerate’s de novo requestthree and six months ended June 30, 2020 primarily due to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit.

Loss from operations includehigher non-cash equity-based compensation of $3.5 millionexpense partially offset by higher revenues and $2.7 million forlower costs compared to the prior year periods. For the three and six months ended SeptemberJune 30, 20172021, loss from operations less non-cash equity-based compensation decreased due to the continued benefit of cost cutting measures taken during 2020 and 2016, respectively, and $11.0 million and $6.6 million for the nine months ended September 30, 2017 and 2016, respectively. 2021.

This loss and further losses are anticipated and was the result of our continued investments in sales and marketing, key research and development expanded laboratorypersonnel, related costs associated with product development, and operational space, increased employee headcount and other factors as we develop and commercializecommercialization of the Company’s products.


Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Total other expense, net$(4,084)$(3,505)$(579)17 %$(8,297)$(7,084)$(1,213)17 %
 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Total other income$285
$117
$168
144% $536
$238
$298
125%


Other non-operating income duringexpense, net for the three and ninesix months ended SeptemberJune 30, 2017,2021 increased dueas compared to anthe three and six months ended June 30, 2020. The increase inwas primarily the result of decreased interest income and dividends, whichincreased interest expense for the three and six months ended June 30, 2021.

For the three months ended June 30, 2021 and 2020, the Company incurred interest expense associated with our convertible notes of $4.2 million and $3.8 million, respectively. For the six months ended June 30, 2021 and 2020, the Company incurred interest expense associated with our convertible notes of $8.2 million and $7.6 million, respectively. These amounts were partially offset by investment income for the three and six months ended June 30, 2021 and 2020, respectively.

Three Months Ended June 30,Six Months Ended June 30,
(in thousands)(in thousands)
20212020$ Change% Change20212020$ Change% Change
Provision for income taxes$— $— $— NM$— $— $— NM

NM indicates percentage is not meaningful

For the three and six months ended June 30, 2021 and 2020, the Company did not carry an income tax provision amount as the Company does not recognize tax benefits from current year tax losses in the U.S. and other components of other income.foreign jurisdictions.


 Three Months Ended Nine Months Ended
 September 30, September 30,
 (in thousands) (in thousands)
 20172016$ Change% Change 20172016$ Change% Change
Provision from income taxes$(45)$
$(45)100% $(220)$
$(220)100%

Due to net losses incurred, we have only recorded tax provisions related to tax liabilities generated by our foreign subsidiaries.
Capital Resources and Liquidity


Our primary source of liquidity has been from sales of shares of common stock.stock, the issuance of our convertible notes and cash from operations. As of SeptemberJune 30, 2017,2021, the Company had $121.3$68.9 million in cash and cash equivalents and available-for-sale securities,investments, an increase of $43.6


$0.6 million from $77.8$68.3 million at December 31, 2016.2020. The primary reason for the changeincrease was from cash provided by the issuance of common stock partially offset by cash used in these assets was a public offering that occurred duringoperating activities. For additional information about the nine months ended September 30, 2017.issuance of common stock, see “Sales of common stock” below.


The Company is subject to lease agreements. The future minimum lease payments under thesesthese lease agreements isare included in Part I, Item 1, Note 16, Commitments.15, Leases.


As of SeptemberJune 30, 2017,2021, management believes that current cash balances will be more than sufficient to fund our capital and liquidity needs for the next twelve months.

The following summarizes selected items in the Company’s consolidated statements of cash flows for the nine months ended September 30, 2017, and 2016:

Cash Flow Summary
(in thousands)
 Nine Months Ended 
 September 30,September 30,Increase (Decrease)
 20172016
Net cash used in operating activities$(42,498)$(40,607)$(1,891)
Net cash used in investing activities(30,907)(52,215)21,308
Net cash provided by financing activities88,303
983
87,320

The net cash used in operating activities was $42.5 million and $40.6 million for the nine months ended September 30, 2017, and 2016, respectively. These losses are the result of our continued investments in research and development, expanded laboratory and operational space, increased employee headcount and other factors as we develop and prepare to commercialize the Company’s products.

The net cash used in investing activities was $30.9 million for the nine months ended September 30, 2017, and is primarily comprised of purchases of available-for-sales securities, offset by sales and maturities of available-for-sale securities. Net cash used in investing activities was $52.2 million for the nine months ended September 30, 2016, and is primarily comprised of purchases of available-for-sale investments, offset by sales and maturities of available-for-sale investments.

The net cash provided by financing activities was $88.3 million for the nine months ended September 30, 2017, and is primarily comprised of proceeds from a public offering. The net cash provided by financing activities was $983,000 for the nine months ended September 30, 2016, and was primarily comprised of the recovery of short swing profits from related parties, offset by common stock issuance cost and the exercise of options and warrants.


Our primary use of capital has been for the development and commercialization of the Accelerate Pheno™ system.Pheno system and development of complementary products. We believe our capital requirements will continue to be met with our existing cash balance and those provided underby revenue, grants, exercises of warrants and stock options and/or additional issuance of equity or debt securities. However, if capital requirements vary materially from those currently planned, or if our business is negatively impacted by the COVID-19 pandemic more seriously or for longer than we currently
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expect, we may require additional capital sooner than expected. There can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to us, if at all. Additional issuances of equity or convertible debt securities will result in dilution to our current common stockholders.


Summary of Cash Flows

The following summarizes selected items in the Company’s condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020:

Cash Flow Summary
Six Months Ended June 30,
(in thousands)
20212020$ Change
Net cash used in operating activities$(22,928)$(27,395)$4,467 
Net cash provided by investing activities8,265 5,692 2,573 
Net cash provided by financing activities23,505 8,038 15,467 

Cash flows from operating activities

The net cash used in operating activities was $22.9 million and $27.4 million for the six months ended June 30, 2021 and 2020, respectively. Net cash used in operating activities was primarily the result of net losses partially offset by equity-based compensation and amortization of debt discount and issuance costs. These losses are the result of continued investments in research and development to further mature the Accelerate Pheno, system and develop a ancillary and next generation products, sales and marketing, along with other factors. An increase in non-cash expenses for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 resulted in a decrease in cash used in operating activities for the current period.

Cash flows from investing activities

The net cash provided by investing activities was $8.3 million for the six months ended June 30, 2021. During the six months ended June 30, 2021, the Company had maturities of marketable securities of $24.0 million, which were offset in part by purchases of marketable securities of $15.7 million. The net cash provided by investing activities was $5.7 million for the six months ended June 30, 2020. During the six months ended June 30, 2020, the Company had maturities of marketable securities of $27.8 million, which were offset in part by purchases of marketable securities of $21.5 million.

The Company had larger marketable securities purchases during the six months ended June 30, 2020 compared to the six months ended June 30, 2021, due to the Company reinvesting a larger portion of its cash and cash equivalents in debt securities available-for-sale during the six months ended June 30, 2020.

Cash flows from financing activities

The net cash provided by financing activities was $23.5 million and $8.0 million for the six months ended June 30, 2021 and 2020, respectively. During the six months ended June 30, 2021, the Company received $21.3 million in proceeds from the issuance of common stock in connection with the Company’s private placement offering and another $0.8 million in proceeds from the issuance of common stock in connection with the Company’s “at-the-market” equity offering program under its Equity Sales Agreement (the “Sales Agreement”) with William Blair & Company, L.L.C. (“William Blair”). This resulted in an increase in net cash provided by financing activities for the six months ended June 30, 2021 compared to the prior year period. For additional information about the issuance of common stock, refer to Part I, Item 1, Note 17, Stockholders’ Equity in this Form 10-Q.

Convertible Notes

On March 27, 2018, the Company issued $150.0 million aggregate principal amount of 2.50% Convertible Senior Notes (“Notes”). In connection with the offering of the Notes, the Company granted the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes on the same terms and conditions. On April 4, 2018 the option was partially exercised, which resulted in $21.5 million
39


of additional proceeds, for total proceeds of $171.5 million. The Notes mature on March 15, 2023, unless earlier repurchased or converted into shares of common stock subject to certain conditions. Upon conversion of the Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock, or a combination of cash and shares of common stock, at the Company's election. The initial conversion rate of the Notes is 32.3428 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $30.92 per share of common stock, subject to adjustment. We pay interest on the Notes semi-annually in arrears on March 15 and September 15 of each year with interest payments beginning on September 15, 2018. Proceeds received from the issuance of the Notes were allocated between long-term debt (the “liability component”) and contributed capital (the “equity component”), within the condensed consolidated balance sheet. The fair value of the liability component was measured using rates determined for similar debt instruments without a conversion feature. For additional information about the Notes, refer to Part I, Item 1, Note 10, Convertible Notes in this Form 10-Q.

In connection with the offering, we entered into a prepaid forward stock repurchase transaction (the “Prepaid Forward”) with a financial institution. Pursuant to the Prepaid Forward, we used approximately $45.1 million of the proceeds from the offering of the Notes to pay the prepayment amount. The aggregate number of our common stock underlying the Prepaid Forward is approximately 1,858,500 shares (based on the sale price of $24.25). The expiration date for the Prepaid Forward is March 15, 2023, although it may be settled earlier in whole or in part. Upon settlement of the Prepaid Forward, at expiration or upon any early settlement, the Forward Counterparty will deliver to us the number of shares of common stock underlying the Prepaid Forward or the portion thereof being settled early. The shares purchased under the Prepaid Forward were treated as treasury stock on the condensed consolidated balance sheet (and not outstanding for purposes of the calculation of basic and diluted earnings per share), but remain outstanding for corporate law purposes, including for purposes of any future stockholders' votes, until the Forward Counterparty delivers the shares underlying the Prepaid Forward to us.

Paycheck Protection Program (PPP) Loan

On April 14, 2020, the Company entered into a promissory note (the “PPP Note”) evidencing an unsecured loan in the amount of $4.8 million. The PPP Note matured on April 14, 2025 and bears interest at a rate of 1% per annum. Beginning August 14, 2021, the Company is required to make 45 monthly payments of principal and interest in the amount of $0.1 million. The PPP Note could be prepaid by the Company at any time prior to maturity with no prepayment penalties. The proceeds from the PPP Note could only be used for payroll costs (including benefits), interest on mortgage obligations, rent, utilities and interest on certain other debt obligations. For additional information about the PPP Note, refer to Part I, Item 1, Note 9, Long-Term Debt in this Form 10-Q.

Pursuant to the terms of the CARES Act and the PPP, the Company could apply to the lender for forgiveness for the amount due on the Loan. The amount eligible for forgiveness is based on the amount of loan proceeds used by the Company (during the 24 week period after the lender makes the first disbursement of loan proceeds) for the payment of certain covered costs, including payroll costs (including benefits), rent and utilities, subject to certain limitations and reductions in accordance with the CARES Act and the PPP. During January 2021, the Company submitted its application for forgiveness to the Lender. On July 15, 2021, the SBA informed the Company of its full forgiveness for the entire Loan amount plus accrued interest, which was $4.8 million as of June 30, 2021. The SBA’s determination of loan forgiveness does not preclude further investigation by the SBA according to its rules and regulations. For additional information about the PPP Note forgiveness, refer to Part I, Item 1, Note 19, Subsequent Events in this Form 10-Q.

Other notes payable

During the three months ended June 30, 2021, the Company entered into three loan agreements with two capital asset financing companies. Loan proceeds were $0.4 million, with interest rates ranging from 9.8% to 12.4 % and maturities ranging from January 1, 2022 to September 2022. For additional information about other notes payable, refer to Part I, Item 1, Note 9, Long-Term Debt in this Form 10-Q.

Sales of common stock

On May 28, 2021, the Company entered into the Sales Agreement with William Blair pursuant to which it may sell shares of the Company’s common stock having an aggregate offering price of up to $50 million, from time to time, through an “at-the-market” equity offering program under which William Blair will act as sales agent. Subject to the terms and conditions of the Sales Agreement, William Blair may sell shares by any method deemed
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to be an “at-the-market” offering as defined in Rule 415 under the Securities Act. The Company is not obligated to sell any shares under the Sales Agreement. William Blair is entitled to a commission of 3% of the aggregate gross proceeds from each sale of shares occurring pursuant to the Sales Agreement. During the six months ended June 30, 2021, the Company sold 92,497 shares of common stock under the Sales Agreement at a price per share of $8.80 resulting in aggregate gross proceeds of $0.8 million.

On December 24, 2020, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain directors and officers of the Company, or entities affiliated or related to such persons, for the issuance and sale by the Company of an aggregate of 4,166,663 shares of the Company’s common stock to the purchasers for an aggregate purchase price of approximately $32 million. The agreement contemplates that the closing of the purchase and sale of the shares will occur in three approximately equal tranches on the dates as specified in the agreement or such other dates as the parties may agree, with the first and second tranches having closed on February 19, 2021 and April 9, 2021, respectively. During the six months ended June 30, 2021, the Company sold 2,777,772 shares of common stock under the Securities Purchase Agreement in first and second tranches at a price per share of $7.68 resulting in aggregate gross proceeds of $21.3 million.

For additional information about the issuance of common stock, refer to Part I, Item 1, Note 17, Stockholders’ Equity in this Form 10-Q.

Off-Balance Sheet Arrangements


We did not have any off-balance sheet arrangements as of SeptemberJune 30, 2017.2021.



Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make certain estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. We evaluate our estimates on an ongoing basis, including those related to accounts receivable, inventories, property and equipment, intangible assets, accruals, warranty liabilities, tax valuation accounts and stock-based compensation. We base our estimates on historical experience and on various other assumptions we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and are not readily apparent from other sources. Actual results may differ from these estimates. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020.


Item 3. Quantitative and Qualitative Disclosures

Interest Rate About Market Risk


Our investment portfolio is exposed to market risk from changes in interest rates. The fair market value of fixed rate securities may be adversely impacted by fluctuations in interest rates while income earned on floating rateNot required for a smaller reporting company.



securities may decline as a result of decreases in interest rates. We have historically maintained a relatively short average maturity for our investment portfolio, and we believe a hypothetical 100 basis point adverse move in interest rates along the entire interest rate yield curve would change the fair value of our interest-sensitive financial instruments by approximately $789,000.
Under our current policies, we do not use interest rate derivative instruments to manage exposure to interest rate changes. We attempt to ensure the safety and preservation of our invested principal funds by limiting default risk, market risk and reinvestment risk. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we maintain a portfolio of cash equivalents and investments in a variety of securities that management believes to be of high credit quality. Further information regarding our investments is included in Item 1, Note 6, Investments.


Item 4. Controls and Procedures


Evaluation of Disclosure Controls and Procedures


Based on an evaluation under the supervision and with the participation of the Company’s management, the Company’s Principal Executive Officer and Principal Financial Officer have concluded that the Company’s disclosure controls and procedures as(as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange ActAct) were effective as of SeptemberJune 30, 2017,2021, to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to the Company’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.


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Changes in Internal Control Over Financial Reporting


During the nine months ended September 30, 2017,There was no change in connection with the Company’s preparationsinternal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2021 that materially affected, or is reasonably likely to commercializematerially affect, the Accelerate Pheno™ system and Accelerate PhenoTest™ BC Kit the Company implemented additionalCompany’s internal controls related to revenue recognition and inventory.control over financial reporting.

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PART II - OTHER INFORMATION


Item 1. Legal Proceedings


On March 19, 2015,We are from time to time subject to various claims and legal actions in the ordinary course of our business. We believe that there are currently no claims or legal actions that would reasonably be expected to have a putative securities class action lawsuit was filed against Accelerate Diagnostics, Inc., Lawrence Mehren, and Steve Reichling, Rapp v. Accelerate Diagnostics, Inc., et al., U.S. District Court, Districtmaterial adverse effect on our results of Arizona, 2:2015-cv-00504. The complaint alleges that we violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, by making falseoperations or misleading statements about our Accelerate Pheno™ system, formerly called the BACcel System. Plaintiff purports to bring the action on behalf of a class of persons who purchased or otherwise acquired our stock between March 7, 2014, and February 17, 2015. On June 9, 2015, Julia Chang was appointed Lead Plaintiff of the purported class. On June 23, 2015, Plaintiff filed an amended complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, by making false or misleading statements or omissions about our ID/AST System and by allegedly employing schemes to defraud. Plaintiff sought certification of the action as a class action, compensatory damages for the class in an unspecified amount, legal fees and costs, and such other relief as the court may order. Defendants moved to dismiss the amended complaint on July 21, 2015. The Court granted the motion and dismissed the case with prejudice on January 28, 2016. On February 26, 2016, Plaintiff filed a notice of appeal with the United States Court of Appeals for the Ninth Circuit, which challenges the dismissal of the amended complaint. Chang v. Accelerate Diagnostics, Inc., et al., No. 2:15-CV-00504-SPL (9th Cir. filed Feb. 26, 2016). On September 13, 2017, Plaintiff voluntarily dismissed the appeal and the case has been dismissed with prejudice.financial condition.




Item 1A. Risk Factors




There have been no material changesIn addition to the risk factors that were disclosedother information set forth in this Form 10-Q, you should carefully consider the risks discussed in the Company’ssection entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016.2020. The risks described in our Annual Report on Form 10-K for the year ended December 31, 2020 are not the only risks facing the Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, results of operations, cash flows and financial position.


Additional Risk Related to Our Business and Strategy


Disruptions in the supply of raw materials, consumable goods or other key product components, or issues associated with their quality from our single source suppliers, could result in a significant disruption in sales and profitability.

We must manufacture or engage third parties to manufacture components of our products in sufficient quantities and on a timely basis, while maintaining product quality, acceptable manufacturing costs and complying with regulatory requirements. Our components are custom-made by only a few outside suppliers. In certain instances, we have a sole source supply for key product components of the Accelerate Pheno system. We may be unable to satisfy our forecast demand from existing suppliers for our products, or we may be unable to find alternative suppliers for key product components or ancillary items at reasonably comparable prices. If this occurs, we may be unable to manufacture our products and/or meet our customers’ needs in a timely manner or at all.

Additionally, we have entered into supply agreements with most of our suppliers to help ensure component availability and flexible purchasing terms with respect to the purchase of such components. If our suppliers discontinue production of a key component for one or more of our products, we may be unable to identify or secure a viable alternative on reasonable terms, or at all, which could limit our ability to manufacture our products. While we may be able to modify our product candidates to utilize a new source of components, we may need to secure marketing authorization from the FDA or other regulatory clearance for the modified product, and it could take considerable time and expense to perform the requisite tasks prior to seeking such authorization.

In determining the required quantities of our products and our manufacturing schedule, we will need to make significant judgments and estimates regarding factors such as market trends and any seasonality with respect to our sales. Because of the inherent nature of estimates, there could be significant differences between our estimates and the actual amounts of products that we require. This can result in shortages if we fail to anticipate demand, or excess inventory and write-offs if we order more than we need.

Reliance on third-party manufacturers entails risk to which we would not be subject if we manufactured these components ourselves, including:

reliance on third parties for regulatory compliance and quality assurance;

possible breaches of manufacturing agreements by the third parties because of factors beyond our control;

possible regulatory violations or manufacturing problems experienced by our suppliers;

possible termination or non-renewal of agreements by third parties, based on their own business priorities, at times that are costly or inconvenient for us;

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the potential obsolescence and/or inability of our suppliers to obtain required components;

the potential delays and expenses of seeking alternate sources of supply or manufacturing services;

the inability to qualify alternate sources without impacting performance claims of our products;

reduced control over pricing, quality and timely delivery due to the difficulties in switching to alternate suppliers or assemblers; and

increases in prices of raw materials and key components.

We are currently experiencing unprecedented cost increases from many of our suppliers. The areas of cost increases include raw materials, components, and value-add supplier labor. We currently have sufficient inventory of Accelerate Pheno devices to limit the impact of cost increases on such devices. However, we are being impacted by cost increases to components and raw materials necessary for the production of our Accelerate Pheno kits. Our kits require these components and raw materials, and many of our supply contracts permit the supplier to pass on certain inflation increases to us. Moreover, our ability to pass on cost increases to our consumable kit customers is limited by long-term contractual price commitments. Prolonged elevated supply costs and further cost increases may eventually impact our cost to manufacture our Accelerate Pheno devices. The supply cost increases we are experiencing and may experience in the future may materially reduce our gross profit margins, thereby negatively impact our overall financial results.

The manufacturing operations for the Accelerate Pheno system use highly technical processes involving unique, proprietary techniques. In addition, the manufacturing equipment we use would be costly to repair or replace and could require substantial lead time to repair or replace. Any interruption in our operations or decrease in the production capacity of our manufacturing facility or the facilities of any of our suppliers because of equipment failure, natural disasters such as earthquakes, tornadoes and fires, or otherwise, would limit our ability to meet customer demand for our products. In the event of a disruption, we may lose customers and we may be unable to regain those customers thereafter. Our insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.


Item 2. Unregistered Sales of Equity Securities and Use of Proceeds


None.None.




Item 3. Defaults Upon Senior Securities


Not applicable.




Item 4. Mine Safety Disclosures


Not applicable.




Item 5. Other Information


None.




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Item 6. Exhibits


Exhibit No.DescriptionFiling Information
Incorporated by reference to Appendix B to the Registrant’s Definitive Proxy Statement on Schedule 14A filed on November 13, 2012
Incorporated by reference to Exhibit A to the Registrant’s Definitive Information Statement on Schedule 14C filed on July 12, 2013
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on March 15, 2016
3.1.3Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on May 15, 2019
3.1.4Incorporated by reference to Exhibit 3.2 filed with3.1 to the Registrant’s AnnualRegistrant's Current Report on Form 10-K for the fiscal year ended July 31, 20128-K filed on May 13, 2021.
3.2Incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on August 8, 2019
31.1Filed herewith
Filed herewith
FiledFurnished herewith
101**101.INSXBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL documentFiled herewith
101**101.SCH Inline XBRL Taxonomy Extension Schema DocumentFiled herewith
101**101.CALInline XBRL Taxonomy Extension Calculation Linkbase DocumentFiled herewith
101**101.DEFInline XBRL Taxonomy Extension Definition Linkbase DocumentFiled herewith
101**101.LABInline XBRL Taxonomy Extension Label Linkbase DocumentFiled herewith
101**101.PREInline XBRL Taxonomy Extension Presentation Linkbase DocumentFiled herewith
104Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)Filed herewith


** Pursuant to applicable securities laws and regulations, we are deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and are not subject to liability under any anti-fraud provisions of the federal securities laws as long as we have made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. Users of this data are advised that, pursuant to Rule 406T, these interactive data files are deemed not filed and otherwise are not subject to liability.
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SIGNATURES


Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.


ACCELERATE DIAGNOSTICS, INC.
August 10, 2021/s/ Jack Phillips
Jack Phillips
President and Chief Executive Officer
(Principal Executive Officer)
November 7, 2017August 10, 2021/s/ Lawrence Mehren
Lawrence Mehren
President and Chief Executive Officer
(Principal Executive Officer)
November 7, 2017/s/ Steve Reichling
Steve Reichling

Chief Financial Officer
(Principal Financial and Accounting Officer)



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