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

þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended SeptemberJune 30, 20172018

o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

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) 
  
3950 South Country Club, Suite 470 
Tucson, Arizona85714
(Address of principal executive offices)(Zip Code)

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

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

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 o  No

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

Large accelerated filer oþ
Accelerated filer þo
Non-accelerated file 
o (Do not check if a smaller reporting company)
Smaller reporting company o
Emerging growth company o

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). o  Yes  þ  No

As of November 1, 2017August 3, 2018 there were 55,397,56354,127,990 shares of the registrant’s common stock outstanding.


TABLE OF CONTENTS
 
 



PART I - FINANCIAL INFORMATION



Item 1. Financial Statements

ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEET
Unaudited
(in thousands)
June 30,December 31,
September 30,December 31,20182017
20172016Unaudited 
ASSETS
Current assets:  
Cash and cash equivalents$34,431
$19,244
$66,810
$28,513
Investments86,889
58,519
130,594
80,648
Trade accounts receivable1,111
34
1,823
1,946
Inventory7,341

11,317
8,063
Prepaid expenses1,048
468
1,421
850
Other current assets460
183
643
468
Total current assets131,280
78,448
212,608
120,488
Property and equipment, net4,690
4,258
5,443
4,890
Intellectual property, net137
146
124
134
Other non-current assets78

Total assets$136,107
$82,852
$218,253
$125,512
  
LIABILITIES AND STOCKHOLDERS EQUITY
LIABILITIES AND STOCKHOLDERS EQUITY
LIABILITIES AND STOCKHOLDERS EQUITY
Current liabilities:  
Accounts payable$1,369
$992
$2,355
$2,080
Accrued liabilities3,733
3,009
5,302
3,636
Deferred revenue and income1,081
35
185
1,071
Total current liabilities6,183
4,036
7,842
6,787
Long-term deferred income
1,000
Other long term liabilities26
21
Convertible notes115,499

Total liabilities$6,183
$5,036
$123,367
$6,808
  
Commitments and contingencies see Note 16, Commitments



Commitments and contingencies



  
Stockholders’ equity:  
Preferred shares, $0.001 par value; 
5,000,000 preferred shares authorized and none outstanding as of June 30, 2018 and December 31, 2017

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

75,000,000 common shares authorized with 54,090,575 shares issued and outstanding on June 30, 2018 and 75,000,000 authorized with 55,673,810 shares issued and outstanding on December 31, 201754
56
Contributed capital355,458
255,257
426,091
360,620
Treasury Stock(45,067)
Accumulated deficit(225,676)(177,289)(286,058)(241,972)
Accumulated other comprehensive (loss)87
(204)
Accumulated other comprehensive loss(134)
Total stockholders’ equity129,924
77,816
94,886
118,704
Total liabilities and stockholders’ equity$136,107
$82,852
$218,253
$125,512
See accompanying notes to consolidated financial statements.


ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Unaudited
(in thousands, except per share data)
Three Months Ended Nine Months EndedThree Months Ended Six Months Ended
September 30, September 30,June 30, June 30,
20172016 2017201620182017 20182017
Net sales$828
$24
 $2,058
$207
$1,692
$699
 $2,493
$1,230
      
Cost of sales191

 352

717
135
 1,210
161
Gross Profit637
24
 1,706
207
Gross profit975
564
 1,283
1,069
      
Costs and expenses:      
Research and development6,351
7,874
 16,166
23,974
6,060
5,527
 12,842
9,815
Sales, general and administrative11,601
9,566
 33,589
26,710
15,330
11,460
 29,682
21,988
Total costs and expenses17,952
17,440
 49,755
50,684
21,390
16,987
 42,524
31,803
      
Loss from operations(17,315)(17,416) (48,049)(50,477)(20,415)(16,423) (41,241)(30,734)
      
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
Other income (expense):   
Interest expense(3,205)
 (3,363)
Foreign currency exchange (loss)(253)(7) (198)(33)
Interest income774
153
 1,075
290
Other expense, net(25)(5) (25)(5)
Total other income (expense), net(2,709)141
 (2,511)252
      
Net loss before income taxes(17,030)(17,299) (47,513)(50,239)(23,124)(16,282) (43,752)(30,482)
Provision from income taxes(45)
 (220)
Provision for income taxes(101)(175) (285)(175)
Net loss$(17,075)$(17,299) $(47,733)$(50,239)$(23,225)$(16,457) $(44,037)$(30,657)
      
Basic and diluted net loss per share$(0.31)$(0.34) $(0.89)$(0.98)$(0.43)$(0.31) $(0.80)$(0.58)
Weighted average shares outstanding55,316
51,239
 53,603
51,216
54,003
53,568
 54,821
52,732
      
Other comprehensive loss:      
Net loss$(17,075)$(17,299) $(47,733)$(50,239)$(23,225)$(16,457) $(44,037)$(30,657)
Net unrealized gain loss on available-for-sale investments(7)(70) (4)11
Net unrealized (loss) gain on available-for-sale investments(2)3
 (55)3
Foreign currency translation adjustment91
(8) 295
(8)(191)204
 (79)204
Comprehensive loss$(16,991)$(17,377) $(47,442)$(50,236)$(23,418)$(16,250) $(44,171)$(30,450)

See accompanying notes to consolidated financial statements.



ACCELERATE DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED
STATEMENTSTATEMENTS OF CASH FLOWS
Unaudited
(in thousands)
Nine Months EndedSix Months Ended
September 30,June 30,
2017201620182017
Cash flows from operating activities:  
Net loss$(47,733)$(50,239)$(44,037)$(30,657)
Adjustments to reconcile net loss to net cash used in operating activities:







Depreciation1,595
1,745
1,072
1,045
Amortization of intangible assets9
8
10
6
Amortization of investment discount298
251
(146)219
Equity-based compensation10,970
6,591
9,011
7,450
Realized (gain) on sale of investments
(6)
Loss on disposal of property & equipment3

Amortization of debt discount and issuance costs2,273

Loss on disposal of property and equipment266
5
(Increase) decrease in assets:







Accounts receivable(1,077)(82)123
(648)
Inventory(7,079)
(4,334)(5,537)
Prepaid expense and other(392)525
(444)(624)
Other current assets(277)(90)(175)(313)
Other non-current assets(78)
Increase (decrease) in liabilities:







Accounts payable359
103
206
528
Accrued liabilities780
670
661
392
Accrued interest1,105

Deferred revenue and income46
(83)(935)43
Deferred compensation5

Net cash used in operating activities(42,498)(40,607)(35,417)(28,091)
Cash flows from investing activities:  
Purchases of equipment(2,055)(2,301)(702)(1,643)
Purchases of available-for-sale securities(68,423)(73,585)(91,272)(39,342)
Sales of available-for-sale securities9,522
8,716
3,000
6,522
Maturity of available-for-sale securities30,049
14,955
38,272
18,449
Net cash used in investing activities(30,907)(52,215)(50,702)(16,014)
Cash flows from financing activities:  
Issuance of common stock net issuance costs83,741
80
Issuance of common stock net of issuance costs276
83,854
Exercise of options and warrants4,562
864
2,757
3,418
Common stock issuance costs
(814)
Payments on capital lease obligations
(13)
Recovery of related party short-swing profits
866
Proceeds from issuance of convertible note171,499

Prepayment of forward stock repurchase transaction(45,069)
Payment of debt issuance costs(4,991)
Net cash provided by financing activities88,303
983
124,472
87,272
 
Effect of exchange rate on cash:289
(15)(56)198
 
Increase (decrease) in cash and cash equivalents15,187
(91,854)
Increase in cash and cash equivalents38,297
43,365
Cash and cash equivalents, beginning of period19,244
120,585
28,513
19,244
Cash and cash equivalents, end of period$34,431
$28,731
$66,810
$62,609
Non-cash investing activities: 
Transfer of instruments from inventory to property and equipment $1,196
$

See accompanying notes to consolidated financial statements.



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”) 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 States 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, 2016,2017, as filed with the SEC on February 28, 2017.March 1, 2018.

The condensed consolidated balance sheet as of December 31, 20162017 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, 2017,2018, 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 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 Company’s consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of the Company’s 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 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, inventories, property and equipment, intangible assets, accruals, warranty liabilities, tax valuation accounts and stock-based compensation. Actual results could differ materially from those estimates.

Estimated Fair Value of Financial Instruments

The Company follows ASC Topic 820, Fair Value Measurements and Disclosures which has defined fair value and requires the Company to establish a framework for measuring fair value and disclose fair value measurements. The framework requires the valuation of assets and liabilities subject to fair value measurements using a three tiered approach and fair value measurement 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;



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, accounts payable, accrued liabilities, and other liabilities approximate the related fair values due to the short-term maturities of these instruments.

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 investments which are primarily held in the custody of major financial institutions. Investments consist of certificate of deposits, debt securities in U.S. government and agency securities, corporate debtcommercial paper, asset-backed securities and certificates of deposit.corporate notes and bonds. Management classifies its investments as available-for-sale investments and


records these investments in the condensed consolidated balance sheet at fair value. The Company considers all 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,(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 assesses whether an other-than-temporary impairment loss has occurred due to declines in fair value or other market conditions when an investment’s fair value remains 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 the cost basis of the investment down to fair value resulting in a realized loss. The new cost basis is not changed for subsequent recoveries in fair value and temporary future increases or decreases in fair value are included in other comprehensive income (loss).

Reclassification

Certain prior year amounts have been reclassified for consistency with the current year presentation and had no effect on our net income, stockholders’ equity or cash flows. In the current period presentation and the revised prior period presentation, depreciation and amortization expenses are reported as a component of the individual costs and expenses as part of the condensed consolidated statements of operations and comprehensive loss. The amount of depreciation and amortization expenses now reported as a component of research and development costs for 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 part of the condensed consolidated statements of operations and comprehensive loss. The amounts that have been reclassified had no effect on our net income, stockholders’ equity or cash flows.

Inventory

Inventory is stated atThe Company writes down its inventory for estimated obsolescence or in an amount equal to the lesserdifference between the cost of cost orinventory and the estimated 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 forecastedupon assumptions about future demand, market conditions and, where applicable, product expiration.

Accounts Receivable

Accounts receivable consist of amounts due to the Company for sales to customers and are recorded net of an allowance for doubtful accounts. Allowances on accounts receivable are recorded when circumstances indicate collection is doubtful for a particular accounts receivable. Receivables are written off if reasonable collection efforts prove unsuccessful. The Company adopted Accounting Standards Update (“ASU”) 2015-11, Simplifying the Measurementprovides for allowances on a specific account basis.

The Company has not included an allowance for doubtful accounts as of Inventory (Topic 310) Inventory on January 1, 2017. This ASU simplifies the subsequent measurementJune 30, 2018 and December 31, 2017, due to no circumstances arising that would indicate collection of inventory by using only the lowerany particular or grouping of cost or net realizable value. The adoption did not have an effect on the Company’s consolidated financial statements.customer accounts receivable is doubtful.



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.

Property and equipment includes diagnostic instruments used for sales demonstrations and instruments under rental agreements. The Company retains title to the instruments under these arrangements.

RevenueLong-lived Assets

Long-lived assets and certain identifiable intangibles to be held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company recognizes revenue in accordance with ASC 605, Revenue Recognition, when persuasive evidencecontinuously evaluates the recoverability 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 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.

We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument 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 arrangementits long-lived assets 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 ofcash flows from and 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.

Equity-Based Compensation

The Company awards stock options 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 such long-lived assets, and provides for impairment if such undiscounted cash flows or 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). For unvested consultant grants, the assumptions are updated at the end of each reporting period until the grant is vested. The Company estimates theestimated fair value of stock option awards, including modifications of stock option awards, usingare insufficient to recover 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 volatilitycarrying amount 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 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.long-lived asset.

Warranty Reserve

Instruments are typically sold with a one year limited warranty, while kits and accessories are typically sold with a sixty60 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, 2018 and 2017 is as follows (in thousands):
 Three Months EndedSix Months Ended
 June 30,June 30,June 30,June 30,
 2018201720182017
Beginning balance$176
$31
$192
$1
Provisions145
50
266
80
Warranty expenses incurred(122)(20)(259)(20)
Ending balance$199
$61
$199
$61

Convertible Notes

The Company issued convertible notes that had conversion prices which resulted in an embedded beneficial conversion feature. The intrinsic value of the beneficial conversion feature was recorded as a debt discount with the corresponding amount recorded to contributed capital. The debt discount is amortized to interest expense over the life of the convertible notes using the effective interest method.

Revenue Recognition

Effective January 1, 2018, the Company adopted the requirements of ASC 606, Revenue from Contracts with Customers, ("Topic 606") and 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.

We determine 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.

Service revenue is derived from the sale of extended service agreements which are generally non-cancelable. 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.

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 standalone selling prices based on the price charged to customers for each individual performance obligation.

We also provide instruments to customers under bundled rental agreements. Under these agreements, we install the instrument 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 five years or less. 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.

Our payment terms vary by the type and location of our customers and the product or services offered and typically range between 30 and 60 days.

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 quarter ended June 30, 2018.

The Company adopted Topic 606 using the modified retrospective method applied to those contracts that were not fully performed by the Company as of January 1, 2018. We recorded a decrease to opening retained earnings and an increase in deferred revenue of $49,000 as of January 1, 2018 due to the cumulative impact of adopting Topic 606. The impact to revenues for the three and six months ended June 30, 2018 was not material as a result of applying Topic 606.  The reported results for 2017 and prior were prepared and are presented under the guidance of ASC 605, Revenue Recognition.

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.

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 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 of the leased property at lease inception. Other leases are classified as operating leases.

Operating lease rent is recorded as an operating expense on a monthly basis. 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 with the amortization expense included with depreciation on the statements of operations and comprehensive loss. For the liability, the amount due within the next year is recorded as a current liability and the amount due in more than a year is recorded as a long-term liability 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 statements of operations and comprehensive loss. As of June 30, 2018 and December 31, 2017, the Company did not carry any capital leases.

Equity-Based Compensation

The Company awards stock options 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). We account for forfeitures as they occur rather than on an estimated basis.

The Company estimates the fair value of 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.

The Company records the fair value of restricted stock units or stock grants based on published closing market price on the day before the grant date.

Income Taxes and Deferred Tax Assets

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 condensed consolidated 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 determine it is more likely than not certain that its tax position will be sustained, 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, withina component of accumulated other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss.stockholders’ equity.

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.



Earnings Per Share

Basic earnings (loss) per share includes no dilution and is computed by dividing income (loss) available to common stockholders by the weighted average number of common shares outstanding for the period. Diluted earnings per share are computed similarly to basic earnings (loss) per share except the denominator includes additional common shares that would have been outstanding if notes convertible at the balance sheet date were converted and share-based payments had been issued. Diluted earnings are not presented when the effect of adding such additional common shares is antidilutive.

NOTE 2. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

In May 2017,June 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2017-09, Compensation—Stock2018-07, Compensation-Stock Compensation (Topic 718)Scope of Modification Accounting. This amendment clarifies when Improvements to accountNonemployee Share-Based Payment Accounting, which simplifies the accounting for a changeshare-based payments made to nonemployees so the terms or conditions of aaccounting for such payments is substantially the same as those made to employees. Under this ASU, share-based payment award as a modification. Under the new guidance, modification accounting is required only if theawards to nonemployees will be measured at fair value on the vesting conditions, or the classificationgrant date of the award (as equity or liability) changes as a resultawards, entities will need to assess the probability of satisfying performance conditions if any are present, and awards will continue to be classified according to Accounting Standards Codification (“ASC”) 718 upon vesting, which eliminates the change in terms or conditions. Itneed to reassess classification upon vesting, consistent with awards granted to employees. This ASU is effective prospectively for the annual period endingfiscal years beginning after December 31,15, 2018, andincluding interim periods within that annual period. Earlythose fiscal years, and early adoption is permitted. Historically, modifications toWe do not anticipate this update will have an effect on our condensed consolidated financial statements because all share-based awards granted to nonemployees are fully vested.
In March 2018, issued ASU 2018-05, Amendments Pursuant to SEC Staff Accounting Bulletin (“SAB”) No. 118 (SEC Update), Income Taxes (Topic 740). ASU 2018-05 provides guidance regarding the recording of tax impacts where uncertainty exists, in the period of adoption of the 2017 U.S. Tax Cuts and Jobs Act (the “Tax Act”). In accordance with this guidance, the Company’s financial results reflect provisional amounts for those specific income tax effects of the Tax Act for which the accounting under ASC Topic 740 is rare. As such, we doincomplete but a reasonable estimate could be determined. During the six months ended June 30, 2018, the Company did not expectrecognize any changes to the applicationprovisional amounts recorded in its 2017 Annual Report on Form 10-K in connection with the Tax Act, as the Company continues to collect the information necessary to complete those calculations. The accounting for the tax effects of this standardthe Tax Act will be completed in the second half of 2018.

In February 2018, the FASB issued ASU 2018-02, Income Statement - Reporting Comprehensive Income (Topic 220) Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (AOCI), which allows a reclassification from accumulated other comprehensive income to have a significantretained earnings for tax effects resulting from the Tax Act that the FASB refers to as having been stranded in AOCI. This ASU is effective for public business entities for annual periods, including interim periods within those annual periods, beginning after December 15, 2018, with early adoption permitted. The Company is evaluating the impact of the adoption of ASU 2018-02 on our condensed consolidated financial statements.statements, though its effects are not expected to be material.

In March 2017, the FASB issued ASU 2017-08, Receivable-Nonrefundable Fees and Other Costs (Topic 310-20) Premium Amortization on Purchased Callable Debt Securities. This amendment shortens the amortization period for certain callable debt securities held at a premium. Specifically, the amendment requires premiums 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 guidanceThis ASU 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 condensed consolidated financial statements and the timing of adoption.statements.



In October 2016, the FASB issued ASU 2016-16, Income Taxes (Topic 740) Intra-Entity Transfers of Assets Other Than Inventory. The update amends accounting guidance for intra-entity transfers of assets other than inventory to require the recognition of income tax consequences when the transfer occurs. The updateThis ASU 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 assessingand eliminates the impactrequirement that the Company recognize the income tax consequences of an intra-entity transfer of an asset upon transfer other than inventory, eliminating the current recognition requirement. This ASU is effective for the 2018 annual reporting period including the interim periods ended March 31, 2018 and June 30, 2018. In adopting this will have on our consolidated financial statementsASU, the Company recorded no cumulative-effect adjustment to retained earnings at January 1, 2018. As the U.S. and the timing of adoption.consolidated group are in a net operating loss position, no prepaid tax has been recorded.

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 losses on financial assets (including trade accounts receivable 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 cost to be presented at the net amount expected to be collected using an allowance for credit losses. Reversal of credit losses on available-for-saleavailable for sale debt securities will be recorded in the current period net income. The amendment will beThis 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 condensed consolidated 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 condensed consolidated 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. TheThis ASU is requiredeffective for us on January 1, 2019, withfiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and early adoption is permitted. We are currently assessing the impact this will have on our condensed consolidated financial statements.

In May 2014,January, 2016, the FASB issued ASU 2014-09, Revenue from Contracts2016-01, Financial Instruments - Overall (Topic 825). This standard requires equity investments, with Customers (Topic 606), which will supersede nearly all existing revenue recognition guidance under U.S. GAAP. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or servicessome exceptions, be measured at fair value with valuation changes recognized in net income, simplifies the impairment assessment of some equity investments, eliminates the requirement to customers in an amount that reflectsdisclose the considerationmethods and significant assumptions used to whichestimate the company expects to be entitled in exchangefair value for those goods or services. In August 2015,financial instruments measured at amortized cost, requires the FASB issued ASU 2015-14, Revenue from Contracts with Customers Deferraluse of the Effective Date, whichexit price notion when measuring the fair value of financial instruments, requires separate presentation of some changes in other comprehensive income, requires separate presentation of financial assets and financial liabilities by measurement category and form of financial assets, and clarifies the need for a valuation allowance on some deferred the effective date resulting in a new 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.tax assets. 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 implementCompany adopted this ASU 2014-09 and all relevant subsequently issued ASU’s on Topic 606 concurrently on January 1, 2018, and are currently evaluating the transition method. We are carefully evaluating our existing revenue recognition practices to determineadoption did not have a material impact on the extent to which our contracts in the scope of the guidance 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 futureCompany’s consolidated financial statements.

NOTE 3. FDA CLEARANCE

On February 23, 2017, 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)(“pre-launch inventory”).

On 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.

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 4. FAIR VALUE OF FINANCIAL INSTRUMENTS

The following tables represent the financial instruments measured at fair value on a recurring basis on the financial statements of the Company and the valuation approach applied to each class of financial instruments at SeptemberJune 30, 2017,2018 and December 31, 2016.2017 (in thousands):

September 30, 2017
(in thousands)June 30, 2018
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: 
 
 
 
 
Cash and cash equivalents 
Cash and cash equivalents: 
Money market funds$19,610
$
$
$19,610
$37,824
$
$
$37,824
Commercial paper
1,800

1,800

5,982

5,982
Corporate notes and bonds
9,087

9,087
Total cash and cash equivalents19,610
1,800

21,410
$37,824
$15,069
$
$52,893
Investments:  
Certificates of deposit
14,367

14,367

13,682

13,682
US Treasury securities12,009


12,009
US Agency securities
7,485

7,485
U.S. Treasury securities31,744


31,744
U.S. Agency securities
6,944

6,944
Commercial paper
10,456

10,456

35,917

35,917
Asset-backed securities
5,024

5,024

8,993

8,993
Corporate notes and bonds
37,548

37,548

33,314

33,314
Total investments12,009
74,880

86,889
31,744
98,850

130,594
Total assets measured at fair value$31,619
$76,680
$
$108,299
$69,568
$113,919
$
$183,487

December 31, 2016
(in thousands)December 31, 2017
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: 
 
 
 
 
Cash and cash equivalents:  
Money market funds$10,970
$
$
$10,970
$7,832
$
$
$7,832
Investments:  
Certificates of deposit
7,257

7,257

13,441

13,441
US Treasury securities8,544


8,544
US Agency securities
4,501

4,501
U.S. Treasury securities14,716


14,716
U.S. Agency securities
8,459

8,459
Commercial paper
9,171

9,171
Asset-backed securities
5,557

5,557

3,025

3,025
Corporate notes and bonds
32,660

32,660

31,836

31,836
Total investments8,544
49,975

58,519
14,716
65,932

80,648
Total assets measured at fair value$19,514
$49,975
$
$69,489
$22,548
$65,932
$
$88,480

Money market fundsHighly liquid investments with an original maturity of three months or less at time of purchase are 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 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 ninesix months ended SeptemberJune 30, 2017.2018.

On March 27, 2018, the Company issued $150.0 million aggregate principal amount of 2.50% Convertible Notes due 2023 (“Notes”). The arrangement provided for a 15% $22.5 million overallotment option to purchase additional Notes 13 days following the execution of the purchase agreement. On April 6, 2018 the option was partially exercised, which resulted in $21.5 million of additional proceeds, for total proceeds of $171.5 million, as described in Note 11, Convertible Notes. The calculated fair value of the Notes, of $159.0 million, is highly correlated to the 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 of the Notes. The fair value of the Notes are classified as Level 2 within the fair value hierarchy.
NOTE 5. 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, including receivables from major customers.

The Company’s mainCompany has financial institutioninstitutions for banking operations that hold 10% or more of the of the Company’s cash and cash equivalents. As of June 30, 2018, two of the Company's financial institutions held 76%58% and 57%28% of the Company’s cash and cash equivalents, respectively. As of December 31, 2017, two of the Company's financial institutions held 82% and 12% of the Company’s cash and cash equivalents, respectively.

The Company grants credit to domestic and international clients in various industries. Exposure to losses on accounts receivable is principally dependent on each client's financial position. The Company has customers who represented 10% or more of the Company’s net accounts receivable balance as of SeptemberJune 30, 2017,2018 and December 31, 2016, respectively.2017. The Company had two customers that accounted for 11% and 10% of the Company’s net accounts receivable balance as of June 30, 2018, and one Customer that accounted for 24% of the Company's net accounts receivable balance as of December 31, 2017.

Customers who represented 10% or more of the Company’s total revenue for the three and six months ended June 30, 2018 and 2017 were as follows:
 Three Months Ended Six Months Ended
 June 30, June 30,
 20182017 20182017
Company A13%* **
Company B12%* **
Company C11%* **
Company D*22% *13%
Company E*21% *12%
Company F*19% *11%
Company G*15% **
Company H** *31%
Company I** *15%

* Less than 10% for the period indicated



NOTE 6. INVESTMENTS

The following tables summarize the Company’s available-for-sale investments at SeptemberJune 30, 2017,2018 and December 31, 2016:2017 (in thousands):

AVAILABLE-FOR-SALE INVESTMENTS
September 30, 2017
(in thousands)
June 30, 2018
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$14,367
$
$
$14,367
$13,682
$
$
$13,682
US Treasury securities12,035

(26)12,009
US Agency securities7,511

(26)7,485
U.S. Treasury securities31,850
1
(107)31,744
U.S. Agency securities7,013

(69)6,944
Commercial paper10,456


10,456
35,917


35,917
Asset-backed securities5,023
1

5,024
8,992
2
(1)8,993
Corporate notes and bonds37,577

(29)37,548
33,388
1
(75)33,314
Total$86,969
$1
$(81)$86,889
$130,842
$4
$(252)$130,594

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
 December 31, 2017
 Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Certificates of deposit$13,441
$
$
$13,441
U.S. Treasury securities14,787

(71)14,716
U.S. Agency securities8,510

(51)8,459
Commercial paper9,171


9,171
Asset-backed securities3,026

(1)3,025
Corporate notes and bonds31,906

(70)31,836
Total$80,841
$
$(193)$80,648

The following table summarizes the maturities of the Company’s available-for-sale securities at SeptemberJune 30, 2017,2018 and December 31, 2016:


2017 (in thousands):

AVAILABLE-FOR-SALE INVESTMENT MATURITIES
(in thousands)
September 30, 2017December 31, 2016June 30, 2018December 31, 2017
Amortized
Cost
Fair ValueAmortized
Cost
Fair ValueAmortized
Cost
Fair ValueAmortized
Cost
Fair Value
Due in less than 1 year$60,999
$60,974
$45,391
$45,344
$95,448
$95,312
$55,801
$55,735
Due in 1-5 years25,970
25,915
13,204
13,175
35,394
35,282
25,040
24,913
Total$86,969
$86,889
$58,595
$58,519
$130,842
$130,594
$80,841
$80,648

Proceeds from sales of marketable securities (including principal paydowns), for the three months endedSeptember June 30, 20172018 and 20162017 were $3.0 million$0 and $7.7$6.5 million, respectively, and for the for the ninesix months endedSeptember June 30, 20172018 and 20162017 were $9.5$3.0 million and $8.7$6.5 million, respectively. The Company determines gains and losses of marketable securities based on specific identification of the securities sold. There were $6,000 ofno realized gains from sales of marketable securities for the three and ninesix months ended SeptemberJune 30, 2016,2018 and no gross realized gains or losses from sales2017. No balances were reclassified out of marketable securitiesaccumulated other comprehensive income (loss) for the three and ninesix months ended SeptemberJune 30, 2017. The gross proceeds associated with the realized gains for the three2018 and nine months ended September 30, 2016 were $7.2 million.2017.

No other-than-temporary impairments are recorded as no material investmentinvestments had a fair value that remained less than its cost for more than twelve months as of September 30, 2017, and there have been no other indicators of impairment.those dates. 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.

Additional information regarding the fair value of our financial instruments is included in Note 4, Fair Value of Financial Instruments.


NOTE 7. INVENTORY

Inventory is statedInventories consisted of the following 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 expenseJune 30, 2018 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 components of inventories were as followsDecember 31, 2017 (in thousands):

September 30,December 31,June 30,December 31,
2017201620182017
Raw materials$4,607
$
$5,101
$4,220
Work in process429

842
377
Finished goods2,305

5,374
3,466
Inventory, net$7,341
$
$11,317
$8,063



NOTE 8. PROPERTY AND EQUIPMENT

Property and equipment are recorded at cost and consisted of the following at SeptemberJune 30, 2017,2018 and December 31, 2016.2017 (in thousands):

PROPERTY AND EQUIPMENT
(in thousands)
September 30,December 31,June 30,December 31,
2017201620182017
Computer equipment$2,865
$2,270
$2,801
$2,756
Technical equipment3,267
2,427
3,550
3,348
Facilities3,512
3,387
3,620
3,621
Instruments1,015

2,283
1,400
Capital projects in progress464
1,010
720
349
Total property and equipment$11,123
$9,094
$12,974
$11,474
Accumulated depreciation - other(6,433)(4,836)
Net property and equipment$4,690
$4,258
Accumulated depreciation(7,531)(6,584)
Property and equipment, net$5,443
$4,890

Depreciation expense (which includes amortization of capital lease assets) for the three months ended SeptemberJune 30, 20172018 and 20162017 was $550,000533,000 and $598,000,$540,000, respectively, and for the ninesix months endedSeptemberJune 30, 20172018 and 20162017 was $1.6$1.1 million and $1.7$1.0 million,, respectively.
NOTE 9. LICENSE AGREEMENTS AND GRANTS

National Institute of Health Grant

In February 2015, 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 for carbepenem-resistant Enterobacteriaceae directly from whole blood. The cumulative sub-award amount awarded to date under these subawards 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.$1.1 million. The amounts invoiced for the three months ended SeptemberJune 30, 2018 and 2017 were $38,000 and 2016 were $180,000 and $8,000,$0, respectively, and for the ninesix months ended SeptemberJune 30, 2018 and 2017 were $98,000 and 2016 were $183,000 and $67,000,$3,000, respectively.

Arizona Commerce Authority

In August 2012, the Company entered into a Grant Agreement (the “Grant 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 relocaterelocating its corporate headquarters to, and expandexpanding its business within, the State of Arizona (the “Project”). Pursuant to the Grant Agreement, the Authority agreed to provideprovided a total grant in the amount of $1.0 million (the “Grant”) for the use by the Company in the advancement of the Project.. The Grant is payable out of an escrow accountwas paid in four installments, upon the achievement 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” iswas a job that iswhich was permanent, full-time, new to Arizona and for which the Company payspaid an average (across all Qualified Jobs identified by the Company in its discretion) annual wageswage of at least $63,000 and offersincluded health insurance benefits, and paysfor which the Company paid 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.premiums. The Grant Agreement also containscontained other customary provisions, including representations, warranties and covenants of both parties. As of September 30,December 31, 2017, the Company has collected all of the $1.0 million in milestones. The full amount iswas collected and recorded in current deferred revenue and income untilincome.

In January 2018, the full amount was recognized due to the economic development provisions of the grant have beenbeing 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. Onceand the “claw-back” provisions expire in January 2018, we will recognize the grantexpiring. The $1.0 million was recognized as an offset to expense. Further details are included in Note 10, Deferred Revenue, Income 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.Remaining Performance Obligations.

NOTE 10. DEFERRED REVENUE, INCOME AND INCOMEREMAINING PERFORMANCE OBLIGATIONS

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 SeptemberJune 30, 2017,2018 and December 31, 2016, follows:2017 follows (in thousands):
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
 June 30,December 31,
 20182017
Products and services not yet delivered$185
$71
Arizona Commerce Authority grant
1,000
Deferred revenue and income$185
$1,071

We have receivedrecognized $14,000 and $35,000 of revenues that were included in the contract liabilities balances during the the three and six months ended June 30, 2018, 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, 2018, $1.0 million in milestone paymentsof revenue is expected to be recognized from remaining performance obligations. This balance primarily relates to executed, service contracts that begin as warranty periods expire. These contracts typically provide for four-year terms and revenue is recognized on a straight-line basis over the Authority undercontract term.
The Company elects not to disclose the Grant Agreement described in Note 9, License Agreementsvalue of unsatisfied performance obligations for (i) contracts with an expected length of one year or less and Grants. As of September 30, 2017, no such payments(ii) contracts for which we recognize revenue at the amount to which we 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.

right to invoice for services performed.


NOTE 11. STOCK PURCHASECONVERTIBLE NOTES

In April 2012, we entered into a Securities Purchase Agreement with Abeja Ventures, LLC pursuant to whichOn March 27, 2018, the Company agreed, among other things,issued $150.0 million aggregate principal amount of 2.50% Convertible Notes due 2023. The arrangement provided for a 15% $22.5 million overallotment option to issue a warrant to purchase additional Notes 13 days following the execution of the purchase agreement. On April 6, 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. The Notes are convertible into shares of the Company’s common stock. Further details of this agreement are included in our Annual Report on Form 10-Kstock, can be repurchased for cash, or a combination thereof, at the fiscal year ended December 31, 2016, as filed with the SEC on February 28, 2017. As of December 31, 2016, there were warrants to purchase 415,871 shares unexercised. During the nine months ended September 30, 2017, warrants to purchase 370,307 shares were exercisedCompany’s election, at an exerciseinitial conversion rate of 32.343 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of $2.00approximately $30.92 per share. Proceedsshare of common stock, subject to adjustment. The Company will pay interest on the Notes semi-annually in arrears on March 15 and September 15 of each year.

The $171.5 million of proceeds received from the exerciseissuance of such warrants totaling $741,000 are recorded as common stockthe 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.

As of June 30, 2018, the outstanding principal amount on the Notes was $171.5 million, the unamortized debt discount was $52.7 million, the unamortized debt issuance cost was $3.3 million and the net carrying amount of the liability component was $115.5 million, which was recorded as convertible notes within the condensed consolidated balance sheet. The remaining warrantsCompany recorded interest expense of $1.1 million for contractual coupon interest for the six months ended months ended June 30, 2018, which is also recorded as accrued interest expense as of June 30, 2018. The Company also recorded $126,000 and $132,000 for amortization of debt issuance costs for the three and six months ended June 30, 2018, respectively, and $2.0 million and $2.1 million for amortization of the debt discount for the three and six months ended June 30, 2018, respectively. As of June 30, 2018, no Notes were convertible pursuant to purchase 45,564their terms.



In connection with the debt 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 expired unexercised on June 26, 2017.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 12. PUBLIC OFFERING

On May 9, 2017, the Company published a prospectus supplement underwritten by J.P. Morgan Securities LLC, William Blair & Company, L.L.C., Piper Jaffray & Co. and BTIG, LLC ("Underwriters") offering 2.8 million shares of common stock with an option for the Underwriters to purchase up to 413,000 additional shares of common stock for a total of 3.2 million shares. The public offering price was $28.850 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 delivered to the purchasers on or around May 15, 2017. The Underwriters partially exercised their option to purchase an additional 335,000 shares, with the sale closing on June 14, 2017, and the option as to the remaining shares expired June 15, 2017. Proceeds from the sales totaled $89.0 million less underwriting discounts, commissions and other costs of $5.8 million for net proceeds of $83.2 million. The net proceeds will be used for general corporate purposes 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.

NOTE 13.12. EARNINGS PER SHARE

The financial statements show basicBasic 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 diluted net loss per share.

share are the same because all outstanding common stock equivalents have been excluded, as they are anti-dilutive due to the Company’s losses.
The Company’s net loss for the periods presented caused the inclusion of all outstanding warrants, restricted stock and options to purchase ourfollowing potentially issuable 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 the computation of diluted net loss per share as thebecause they would have an anti-dilutive effect was antidilutive.due to net losses at June 30, 2018 and December 31, 2017 (in thousands):
 June 30,December 31,
 20182017
Shares issuable upon the release of restricted stock awards16
24
Shares issuable upon exercise of stock options8,093
7,328
 8,109
7,352

NOTE 14.13. EMPLOYEE EQUITY-BASED COMPENSATION

The following table summarizes option activity under all plans during the nine-monthsix-month period ending Septemberended June 30, 2017:2018:

Stock Option Activity
Number of SharesWeighted Average Exercise Price per ShareNumber of SharesWeighted Average Exercise Price per Share
Options outstanding December 31, 20166,857,124
$7.72
Options Outstanding January 1, 20187,328,131
$10.16
Granted1,113,861
24.49
1,115,371
25.45
Forfeited(131,167)21.41
(91,043)20.97
Exercised(384,812)9.93
(253,621)10.87
Expired(6,422)24.45
(5,495)23.43
Options Outstanding September 30, 20177,448,584
9.86
Options Outstanding June 30, 20188,093,343
12.11

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
Three Months EndedJune 30,
September 30, 2017September 30, 201620182017
Expected term (in years)6.46
6.46
6.06
6.12
Volatility74%89%64%75%
Expected dividends



Risk free interest rates2.02%1.30%2.82%2.02%
Weighted average fair value$15.74
$15.40
$13.53
$16.80

The following table shows summary information for outstanding options and options that are exercisable (vested) as of SeptemberJune 30, 2017:2018:

Stock Option Supplemental Information
Options
Outstanding
Options
Exercisable
Options
Outstanding
Options
Exercisable
Number of options7,448,584
5,214,464
8,093,343
5,689,985
Weighted average remaining contractual term (in years)6.32
5.40
6.18
5.13
Weighted average exercise price$9.86
$6.02
$12.11
$8.00
Weighted average fair value$7.31
$4.51
$8.52
$5.68
Aggregate intrinsic value (in thousands)$96,074
$86,005
$88,348
$83,067

The following table summarizes restricted stock unit and restricted stock award activity during the nine-monthsix-month period ending SeptemberJune 30, 2017:2018:

Restricted Stock Unit (RSU) and Restricted Stock Award (RSA) Activity
Number of SharesWeighted Average Grant Date Fair Value per ShareNumber of SharesWeighted Average Grant Date Fair Value per Share
RSUs & RSAs Outstanding December 31, 201640,250
$20.91
Outstanding January 1, 201824,150
$26.45
Granted1,911
22.40


Forfeited



Vested/released(18,011)21.07
(8,050)26.45
RSUs & RSAs outstanding September 30, 201724,150
20.91
Outstanding June 30, 201816,100
26.45

The expense recognized on the Company’s condensed consolidated statements of operations and comprehensive loss related to optionsEquity-based compensation is summarized below:below (in thousands):

Equity-Based Compensation Expenses
(in thousands)
Three Months EndedSix Months Ended
Three Months EndedNine Months EndedJune 30,
September 30, 2017September 30, 2016September 30, 2017September 30, 20162018201720182017
Cost of sales$22
$
$44
$
$58
$22
$104
$22
Research and development994
504
2,886
1,168
838
1,166
2,450
1,892
Sales, general and administrative2,504
2,166
8,040
5,423
2,513
3,047
6,457
5,536
Equity-based compensation expense$3,520
$2,670
$10,970
$6,591
$3,409
$4,235
$9,011
$7,450

As of June 30, 2018 and 2017, $420,000 and $183,000 of equity-based compensation expense was included as a component of capitalized inventory, respectively. As of June 30, 2018 and 2017, $77,000 and $27,000 of equity-based compensation expense was included as a component of capitalized property and equipment, respectively.



As of SeptemberJune 30, 2017, $262,000 and $33,000 of2018, unrecognized 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$22.8 million and $216,000$111,000, respectively. This is expected to be recognized over the years 20172018 through 2022.

As discussed in Note 1, we 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 and, therefore, equity based compensation expense for the three and nine months ended September 30, 2017 has been calculated 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.2023.

NOTE 15.14. INCOME TAXES

For the ninethree and six months ended SeptemberJune 30, 2017,2018, the Company recorded a provision for income taxes of $220,000,approximately $101,000 and $285,000, respectively, which primarily relatedrelates to a profitable foreign jurisdictionjurisdictions without any net operating loss carryforwards. The Company’s tax expense for the ninethree and six months ended SeptemberJune 30, 20172018 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$23.1 million and $43.8 million, respectively, as no tax benefits were recorded for tax losses generated in the U.S. and other foreign jurisdictions. At SeptemberJune 30, 2017,2018, 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 SeptemberWe account 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, 2017, the Company had gross unrecognized2018, we did not note any significant changes to our uncertain tax benefits of $1.1 million. The Company ispositions. We do not currently under examination by taxing authorities and does not believe the amount of unrecognizedanticipate significant changes to uncertain tax benefits will significantly increase or decrease overposition within the next 12 months.

Tax Cuts and Jobs Act

On December 22, 2017, President Trump signed into law the Tax Cuts and Jobs Act. The Tax Act reduced the corporate tax rate from the maximum federal statutory rate of 35% to 21%. The Tax Act states that the 21% corporate tax rate is effective for tax years beginning on or after January 1, 2018. The Company revalued its net deferred tax assets for U.S. federal purposes to 21% as of December 31, 2017, with a corresponding adjustment to the valuation allowance. Therefore, the reduction in the U.S. corporate tax rate had no impact on the Company's earnings.

In conjunction with the Tax Act, the SEC staff issued SAB 118 to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Act. The Company has recognized the provisional tax impacts related to deemed repatriated earnings and the revaluation of deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts, possibly materially, due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Act. Any subsequent determinations and adjustments will be recorded during the remainder of the year ended December 31, 2018, as they are identified. 

The Tax Act subjects a U.S. shareholder to tax on global intangible low-taxed income (“GILTI”) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for GILTI, states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. Given the complexity of the GILTI provisions, we are still evaluating the effects of the GILTI provisions and have not yet determined our accounting policy. At June 30, 2018, because we are still evaluating the GILTI provisions and our analysis of future taxable income subject to GILTI, we have included GILTI related to current-year operations only in our estimated annual effective tax rate, with a corresponding adjustment to the valuation allowance, and have not provided additional GILTI on deferred items.

At June 30, 2018, the Company has not completed its accounting for all of the tax effects of the Tax Act and has not made any adjustments to the provisional amounts recorded at December 31, 2017. The Company will continue to make and refine its calculations as additional analysis is completed. The Company’s estimates may also be affected as additional guidance is issued with regards to the Tax Act. These changes are not expected to be material to the Company’s financial statements since the effective tax rate impact will be offset by the corresponding adjustment in the valuation allowance.



NOTE 16.15. COMMITMENTS

Leases

The Company has entered into lease agreements, lease amendments, and lease extensions (“Lease Agreements”) for office, laboratory and manufacturing space located in Tucson, Arizona and Europe, the last of which expires in 2022. Total rent expense, including common area charges was $308,000$346,000 and $286,000$309,000 for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and for the ninesix months ended SeptemberJune 30, 2018 and 2017 was $688,000 and 2016 was $933,000 and $826,000,$625,000, respectively. Future minimum lease payments under operating leasethese agreements are as follows:follows (in thousands):

Operating Lease Obligations
(in thousands)
Year ending December 31:  
2017$264
20181,022
$557
2019180
206
202065
85
202130
44
20224
Thereafter4

Total operating lease obligations$1,565
$896

Clinical Trial Agreements

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 indemnify the clinical trial sites from any and all losses arising from third party claims as a result of the Company’sCompany'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 Company's condensed consolidated statements of operations and comprehensive loss.

Legal MattersMarketing Study and Contracted Research

On March 19, 2015,The Company has entered into marketing study agreements and contracted research agreements with research institutions and hospitals in which we typically pay a putative securities class action lawsuit was filed against Accelerate Diagnostics, Inc., Lawrence Mehren,set amount for start-up costs 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)then pay for work performed. These agreements typically indemnify the sites from any and 20(a)all losses arising from third party claims as a result of the Securities Exchange Act of 1934 and SEC Rule 10b-5, by making falseCompany's negligence, willful misconduct 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.


misrepresentation.

NOTE 17. SEGMENTS16. INDUSTRY, GEOGRAPHIC AND REVENUE DISAGGREGATION

The Company operates as one operating segment. Operating segments are defined as componentsSales to customers outside the U.S. represented 28% and 22% for the three months endedJune 30, 2018 and 2017, respectively, and 27% and 14% for the six months ended June 30, 2018 and 2017, respectively.

As of an enterpriseJune 30, 2018 and December 31, 2017, balances due from foreign customers, in U.S. dollars, were $864,000 and $1.0 million, respectively.



 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017 20182017
Primary Geographic Markets:     
Domestic$1,220
$544
 $1,815
$1,063
Foreign472
155
 678
167
Net sales$1,692
$699
 $2,493
$1,230
      
Line of Business:     
Accelerate Pheno™ revenue$1,665
$675
 $2,435
$1,180
Other revenue27
24
 58
50
Net sales$1,692
$699
 $2,493
$1,230
      
Products and Services:     
Products$1,671
$695
 $2,467
$1,224
Services21
4
 26
6
Net sales$1,692
$699
 $2,493
$1,230

Lease income included in net sales for the three months endedJune 30, 2018 and 2017 was $172,000 and $11,000, respectively, and $181,000 and $12,000 for the six months ended June 30, 2018 and 2017, respectively, which separate financial information is evaluated regularlydoes not represent revenues recognized from contracts with customers.

The following presents long-lived assets (excluding intangible assets) 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.geographic territory (in thousands):
 June 30,December 31,
 20182017
Domestic$4,210
$3,779
Foreign1,233
1,111
Property and equipment, net$5,443
$4,890

NOTE 18.17. 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)As part of the Securities Exchange Acttransaction discussed in Note 11, Convertible Notes, an affiliate of 1934, as amended.one member of the Company's board of directors purchased an aggregate of $30 million of the Notes. The Company recognized these related party proceeds as an increase to contributed capital onaffiliated entity is a Qualified Institutional Buyer which purchased and holds the condensed consolidated balance sheet.Notes at June 30, 2018.


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.


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 the plans and objectives of management for future operations, including plans and objectives relating to the products and future economic performance of the Company. 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.

The forward-looking statements included herein are based on current expectations that involve a number of risks and uncertainties. These forward-looking statements are based on assumptions that the Company will retain key management personnel, the Company will be successful in the commercialization of the Accelerate Pheno™ system, the Company will obtain sufficient capital to commercialize the Accelerate 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. 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


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, 2016,2017, 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. (“Accelerate”) 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 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 built to address these challenges by delivering significantly faster and more accurate testing of infectious pathogens in various patient sample types.

Since 2004, we have focused our efforts on the research, intodevelopment, and the developmentcommercialization of an innovative rapid diagnostic platform, the Accelerate Pheno™ system, intended for the rapid 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 identification and susceptibility results.

system. The Accelerate Pheno™ system utilizes genotypic technology to identify or “ID,”(ID) infectious pathogens and phenotypic technology to conduct antibiotic susceptibility testing, or “AST,”(AST) which determines whether live bacterial orand fungal cells are resistant or susceptible to a particular antimicrobial agent.antibiotic. 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 is a highly multiplexed panel targeting over 80% of the routine and significant pathogens causing blood stream infections and over 90% of the antibiotics useful in treating those pathogens.

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

In 2017, we began selling the Accelerate Pheno™ system in hospitals in the United States. The Accelerate PhenoTest™ BC kit includes 140 assays for both identificationStates, Europe, and susceptibility testing, of which 116the Middle East. Consistent with the Company's business model revenues were cleared bygenerated from the FDA and 24 assays are available in a Research Use Only modesale of the software.instrument and the sale of single use consumable test kits.

Changes in Results of Operations: Three and ninesix months ended SeptemberJune 30, 20172018 compared to three and ninesix months ended SeptemberJune 30, 20162017

 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 Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Net sales$1,692
$699
$993
142% $2,493
$1,230
$1,263
103%

For the three and ninesix months ended SeptemberJune 30, 2017,2018, total revenues increased due to sales of Accelerate Pheno™ systems and Accelerate PhenoTest™ BC kits.

Three Months Ended Nine Months EndedThree Months Ended Six Months Ended
September 30, September 30,June 30, June 30,
(in thousands) (in thousands)(in thousands) (in thousands)
20172016$ Change% Change 20172016$ Change% Change20182017$ Change% Change 20182017$ Change% Change
Cost of sales$191
$
$191
100% $352
$
$352
100%$717
$135
$582
431% $1,210
$161
$1,049
652%
Gross Profit$637
$24
$613
2,554% $1,706
$207
$1,499
724%
Gross profit$975
$564
$411
73% $1,283
$1,069
$214
20%

For the three and ninesix months ended SeptemberJune 30, 2017,2018, cost of sales and gross profit increased as a result of of higher sales for the Company capitalizing inventory in connection with the FDA granting Accelerate’s de novo request to market the Accelerate Pheno™ systemthree and Accelerate PhenoTest™ BC kit.

six months ended June 30, 2018. Inventory without a cost basis was sold to customers duringfor the three and ninesix months ended SeptemberJune 30, 2018 and 2017. ThisSales for the three and six months ended June 30, 2018 included proportionately fewer sales of inventory was comprisedexpensed in a previous period; this decrease contributed to an increase in cost of pre-launchsales and less gross profit. Pre-launch inventory previously not capitalized and expensed in a previous period. period for the three months ended June 30, 2018 and 2017, was $122,000 and $187,000, respectively, and $244,000 and $367,000 for the six months ended June 30, 2018 and 2017, respectively.

Cost of sales associated with this inventory duringincluded non-cash equity-based compensation of $58,000 and $22,000 for the three and nine months ended SeptemberJune 30, 2018 and 2017, would have been an additional $244,000respectively, and $611,000,$104,000 and $22,000 for the six months ended June 30, 2018 and 2017, respectively.

 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
$(7,808)(33)%
 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Research and development$6,060
$5,527
$533
10% $12,842
$9,815
$3,027
31%

Research and development expenses for the three and nine months ended SeptemberJune 30, 2017, decreased2018 increased as compared to the same periods inthree months ended ended June 30, 2017. The increase was primarily the prior year as a result of increasing employee salaries, in preparation of upcoming clinical trialtrials and studies, as well as, an increase in purchases of engineering supplies to


support research and development. Research and development expenses not recurring in the current periods. Additionally, on 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 for the Accelerate Pheno™ systemsix months ended June 30, 2018 increased as compared to the six months ended ended June 30, 2017. The increase was primarily the result of increasing employee salaries, non-cash equity-based compensation and Accelerate PhenoTest™ BC kit. As a result, the Company started capitalizing pre-launch inventory for the Accelerate Pheno™ systemincreases in purchases of engineering supplies to support research 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.development.

Pre-launch inventory not capitalized in accordance with U.S. GAAP, which included instruments and consumables charged to research and development, were $225,000$0 and $795,000$76,000 for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and $376,000$25,000 and $3.9 million$151,000 for the ninesix months ended SeptemberJune 30, 20172018 and 2016,2017, respectively.

Research and development expenses includeincluded non-cash equity-based compensation of $1.0$838,000 and $1.2 million and $504,000 for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and $2.9$2.5 million and $1.2$1.9 million for the ninesix months ended SeptemberJune 30, 2018 and 2017, and 2016, respectively. The increaseIn March of 2018, the Company granted immediately vested stock options as a part of its annual bonus program, which increased expenses relative to the same periods in non-cash equity-based compensation was primarily driven by an increase in the number of employees and stock option grants.2017.

 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%


 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Sales, general and administrative$15,330
$11,460
$3,870
34% $29,682
$21,988
$7,694
35%

Sales, general and administrative expenses for the three and nine months ended SeptemberJune 30, 2017,2018 increased dueas compared to the three months ended ended June 30, 2017. The increase was primarily the result of an increase in salaries and related expenses as we continued to ramp up our sales and marketing operations globally. Sales, general and administrative expenses for the six months ended June 30, 2018 increased as compared to the six months ended ended June 30, 2017. The increase was primarily the result of an increase an increase in salaries, non-cash equity-based compensation and related expenses as we continued to 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$0 and $1.2 million$12,000 for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and $40,000$0 and $2.5 million$29,000 for the ninesix months ended SeptemberJune 30, 20172018 and 2016,2017, respectively.

Sales, general and administrative expenses includeincluded non-cash equity-based compensation of $2.5 million and $2.2$3.0 million for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and $8.0$6.5 million and $5.4$5.5 million for the ninesix months ended SeptemberJune 30, 2018 and 2017, and 2016, respectively. The increaseIn March of 2018, the Company granted immediately vested stock options as a part of its annual bonus program, which increased expenses relative to the same periods in non-cash equity-based compensation was primarily driven by an increase in the number of employees and stock option grants.2017.

 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)$2,428
(5)%
 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Loss from operations$(20,415)$(16,423)$(3,992)24% $(41,241)$(30,734)$(10,507)34%

For the three and ninesix months end Septemberended June 30, 2017,2018, our loss from operations decreased as aincreased. The increase was the result of the Company capitalizing inventoryour continued investments in connectionresearch and development, sales and marketing, and increased employee headcount, along with the FDA granting Accelerate’s de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit.other factors.

Loss from operations includeincluded non-cash equity-based compensation of $3.5$3.4 million and $2.7$4.2 million for the three months ended SeptemberJune 30, 20172018 and 2016,2017, respectively, and $11.0$9.0 million and $6.6$7.5 million for the ninesix months ended SeptemberJune 30, 20172018 and 2016,2017, respectively. 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 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
$298
125%
 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Total other income (expense), net$(2,709)$141
$(2,850)(2,021)% $(2,511)$252
$(2,763)(1,096)%

Other non-operating income duringexpense for the three and ninesix months ended SeptemberJune 30, 2018 increased compared to the three and six months ended June 30, 2017, increasedprimarily due to an increase in interest and dividends, which wereexpense associated with our convertible notes, offset in part by other components of other income.expenses.

 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% $(220)$
$(220)100%
 Three Months Ended Six Months Ended
 June 30, June 30,
 (in thousands) (in thousands)
 20182017$ Change% Change 20182017$ Change% Change
Provision for income taxes$(101)$(175)$74
(42)% $(285)$(175)$(110)63%

Due to net losses incurred, we have only recorded tax provisions related to tax liabilities generated by our foreign subsidiaries.subsidiaries for international income taxes.


Capital Resources and Liquidity

Our primary source of liquidity has been from sales of shares of common stock.stock and issuances of convertible notes. As of SeptemberJune 30, 2017,2018, the Company had $121.3$197.4 million in cash and cash equivalents and available-for-sale securities, an increase of $43.6


$88.2 million from $77.8$109.2 million at December 31, 2016.2017. The primary reason for the change in these assets was a publicconvertible note offering that occurred during the ninesix months ended SeptemberJune 30, 2017.2018.

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

As of SeptemberJune 30, 2017,2018, 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 ninesix months ended SeptemberJune 30, 2017,2018 and 2016:2017:

Cash Flow Summary
(in thousands)
Cash Flow Summary
(in thousands)
Cash Flow Summary
(in thousands)
Nine Months Ended Six Months Ended 
September 30,Increase (Decrease)June 30,Increase (Decrease)
2017201620182017
Net cash used in operating activities$(42,498)$(40,607)$(1,891)$(35,417)$(28,091)$(7,326)
Net cash used in investing activities(30,907)(52,215)21,308
(50,702)(16,014)(34,688)
Net cash provided by financing activities88,303
983
87,320
124,472
87,272
37,200

The net cash used in operating activities was $42.5$35.4 million and $40.6$28.1 million for the ninesix months ended SeptemberJune 30, 2017,2018 and 2016,2017, respectively. These losses are the result of our continued investments in research and development, expanded laboratorysales and operational space,marketing, and increased employee headcount, andalong with other factors as we develop and prepare to commercialize the Company’s products.factors.

The net cash used in investing activities was $30.9$50.7 million for the ninesix months ended SeptemberJune 30, 2017,2018 and $16.0 million for the six months ended June 30, 2017. The net cash used is primarily comprised of the purchases of available-for-salesavailable-for-sale securities, offset by sales and maturities of available-for-sale securities. Net cash used in investing activities was $52.2 millionsecurities 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.both periods.



The net cash provided by financing activities was $88.3$124.5 million for the ninesix months ended SeptemberJune 30, 2017,2018, and is primarily comprised of proceeds from our convertible note offering, offset by the prepayment of a public offering.forward stock repurchase. The net cash provided by financing activities was $983,000$87.3 million for the ninesix months ended SeptemberJune 30, 2016,2017, and was primarily comprised of the recoverysale of short swing profits from related parties, offset by common stock issuance cost and the exercise of options and warrants.stock.

Our primary use of capital has been for developmentthe commercialization and commercializationdevelopment of the Accelerate Pheno™ system. We believe our capital requirements will continue to be met with our existing cash balance and those provided under 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, 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.

Convertible Notes

On March 27, 2018, the Company issued $150.0 million aggregate principal amount of 2.50% Notes. The arrangement provided for a 15% $22.5 million overallotment option to purchase additional Notes 13 days following the execution of the purchase agreement. On April 6, 2018 the option was partially exercised, which resulted in $21.5 million 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. The Notes are convertible into shares of the Company’s common stock, can be repurchased for cash, or a combination thereof, at the Company’s election, at an initial conversion rate of 32.343 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 will 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 was 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.

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 1.9 million 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. We intend to use the remaining net proceeds less issuance cost from the offering of approximately $121.4 million for general corporate purposes.

Off-Balance Sheet Arrangements

We did not have any off-balance sheet arrangements as of SeptemberJune 30, 2018.

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 is 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, 2017. Additional critical accounting policies


added to Note 1, Organization and Nature of Business; Basis of Presentation; Principles of Consolidation; Significant Accounting Policies include the the adoption of ASC 606, Revenue from Contracts with Customers, and the Company's accounting policy on convertible notes during the six months ended June 30, 2018.


Item 3. Quantitative and Qualitative Disclosures

Interest Rate 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 rate


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-sensitiveinterest sensitive financial instruments by approximately $789,000.$907,000 as of June 30, 2018 and $555,000 as of December 31, 2017.

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.

Foreign Currency Risk

We operate primarily in the United States and a majority of our cost, expense and capital purchasing activities for the six months ended June 30, 2018 were transacted in United States dollars. As a corporation with international and domestic operations, we are exposed to changes in foreign exchange rates. Our international revenue is predominantly in Europe and the Middle East and is denominated in Euros and United States dollars. In our international operations, we pay payroll and other expenses in local currencies. Our exposures to foreign currency risks may change over time and could have a material adverse impact on our financial results.


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 defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act were effective as of SeptemberJune 30, 2017,2018, 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.

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 during the period ended June 30, 2018 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.



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



ThereExcept as described below, there have been no material changes to the risk factors that were disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 20162017.

Risks related to our convertible senior notes

We have indebtedness in the form of convertible senior notes.

On March 27, 2018, the Company issued $150.0 million aggregate principal amount of 2.50% Notes. The arrangement provided for a 15% $22.5 million overallotment option to purchase additional Notes 13 days following the execution of the purchase agreement. On April 6, 2018 the option was partially exercised, which resulted in $21.5 million of additional proceeds, for total proceeds of $171.5 million. Holders of the Notes will have the right to require us to repurchase their Notes upon the occurrence of a fundamental change at a purchase price equal to 100% of the principal amount of the Notes to be purchased, plus accrued and unpaid interest, if any. In addition, the indenture for the Notes provides that we are required to repay amounts due under the indenture in the event that there is an event of default for the Notes that results in the principal, premium, if any, and interest, if any, becoming due prior to maturity date for the Notes. There can be no assurance that we will be able to repay this indebtedness when due, or that we will be able to refinance this indebtedness on acceptable terms or at all. In addition, this indebtedness could, among other things:

heighten our vulnerability to adverse general economic conditions and competitive pressures;

require us to dedicate a larger portion of our cash flow from operations to interest payments, limiting the availability of cash for other purposes;

limit our flexibility in planning for, or reacting to, changes in our business and industry; and

impair our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions, general corporate purposes or other purposes.

Our failure to repurchase Notes at a time when the repurchase is required by the indenture (whether upon a fundamental change or otherwise under the indenture) or pay cash payable on future conversions of the Notes as required by the indenture would constitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under agreements governing our existing or future indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness, repurchase the Notes or make cash payments upon conversions thereof.

The prepaid forward may affect the value of the Notes and our common stock and may result in unexpected market activity in the Notes and/or our common stock.

In connection with the issuance of the Notes, we entered into a prepaid forward with a forward counterparty. The prepaid forward is intended to facilitate privately negotiated derivative transactions by which investors in the Notes will be able to hedge their investment. In connection with establishing its initial hedge of the prepaid forward, the forward counterparty (or its affiliate) was to purchase shares of our common stock from, and/or enter into one or more derivative transactions with respect to our common stock, with purchasers of the Notes concurrently with or after the offering of the Notes. The prepaid forward is intended to reduce the dilution to our stockholders from the issuance of our common stock (if any) upon conversion of the Notes and to allow certain investors to establish short positions that generally correspond to initial hedges of their investment in the Notes. Neither we nor the forward counterparty control how such investors may use such derivative transactions. In addition, such investors may enter into other transactions in connection with such derivative transactions, including the purchase or sale of our common stock, at any time. As a result, the existence of the prepaid forward, such derivative transactions, and any related market activity could cause


more sales of our common stock over the term of the prepaid forward than there would have otherwise been had we not entered into the prepaid forward. Such sales could potentially impact the market price of our common stock and/or the Notes.

We are subject to counterparty risk with respect to the prepaid forward.

We will be subject to the risk that the forward counterparty might default under the prepaid forward. Our exposure to the credit risk of the forward counterparty will not be secured by any collateral. Global economic conditions have in the recent past resulted in, and may again result in, the actual or perceived failure or financial difficulties of many financial institutions. If the forward counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings, with a claim equal to our exposure at that time under our transactions with the forward counterparty. Our exposure will depend on many factors, but, generally, an increase in our exposure will be correlated to an increase in the market price of our common stock. In addition, upon a default by the forward counterparty, we may suffer more dilution than we currently anticipate with respect to our common stock. We can provide no assurances as to the financial stability or viability of the forward counterparty to the prepaid forward.


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

None.


Item 3. Defaults Upon Senior Securities

Not applicable.


Item 4. Mine Safety Disclosures

Not applicable.


Item 5. Other Information

None.




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
Incorporated by reference to Exhibit 3.2 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
Incorporated by reference to Exhibit 3.1 filed with the Registrant’s Current Report on Form 8-K filed on November 16, 2017
Incorporated by reference to Exhibit 4.1 filed with the Registrant’s Current Report on Form 8-K filed on March 28, 2018
Incorporated by reference to Exhibit 4.2 filed with the Registrant’s Current Report on Form 8-K filed on March 28, 2018
Incorporated by reference to Exhibit 10.1 filed with the Registrant’s Current Report on Form 8-K filed on March 28, 2018
Incorporated by reference to Exhibit 10.2 filed with the Registrant’s Current Report on Form 8-K filed on March 28, 2018
Filed herewith
Filed herewith
Filed herewith
101**XBRL Instance Document 
101**XBRL Taxonomy Extension Schema Document 
101**XBRL Taxonomy Calculation Linkbase Document 
101**XBRL Taxonomy Extension Definition Linkbase Document 
101**XBRL Taxonomy Label Linkbase Document 
101**XBRL Taxonomy Presentation Linkbase Document 

** 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.



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.
NovemberAugust 7, 20172018/s/ Lawrence Mehren
 
Lawrence Mehren
President and Chief Executive Officer
 (Principal Executive Officer)
  
NovemberAugust 7, 20172018/s/ Steve Reichling
 
Steve Reichling
Chief Financial Officer
 (Principal Financial and Accounting Officer)


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