Delaware
|
84-1072256
|
(State or other jurisdiction
|
(I.R.S. Employer Identification No.)
|
of incorporation or organization)
|
|
|
|
3950 South Country Club Road, Suite 470
|
|
Tucson, Arizona
|
85714
|
(Address of principal executive offices)
|
(Zip Code)
|
Large accelerated filer
|
|
þ
|
Accelerated filer
|
|
o
|
Non-accelerated file
|
|
o
|
Smaller reporting company
|
|
þ
|
Emerging growth company
|
|
o
|
|
|
|
|
|
September 30,
|
December 31,
|
||||
|
2018
|
2017
|
||||
|
Unaudited
|
|
||||
ASSETS
|
||||||
Current assets:
|
|
|
||||
Cash and cash equivalents
|
$
|
61,622
|
|
$
|
28,513
|
|
Investments
|
118,982
|
|
80,648
|
|
||
Trade accounts receivable
|
1,440
|
|
1,946
|
|
||
Inventory
|
9,406
|
|
8,063
|
|
||
Prepaid expenses
|
940
|
|
850
|
|
||
Other current assets
|
494
|
|
468
|
|
||
Total current assets
|
192,884
|
|
120,488
|
|
||
Property and equipment, net
|
7,412
|
|
4,890
|
|
||
Intellectual property, net
|
119
|
|
134
|
|
||
Other non-current assets
|
241
|
|
—
|
|
||
Total assets
|
$
|
200,656
|
|
$
|
125,512
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS
’
EQUITY
|
||||||
Current liabilities:
|
|
|
||||
Accounts payable
|
$
|
1,559
|
|
$
|
2,080
|
|
Accrued liabilities
|
3,518
|
|
3,636
|
|
||
Accrued interest
|
191
|
|
—
|
|
||
Deferred revenue and income
|
202
|
|
1,071
|
|
||
Total current liabilities
|
5,470
|
|
6,787
|
|
||
Other long term liabilities
|
26
|
|
21
|
|
||
Convertible notes
|
117,754
|
|
—
|
|
||
Total liabilities
|
$
|
123,250
|
|
$
|
6,808
|
|
|
|
|
||||
Commitments and contingencies
|
|
|
|
|
||
|
|
|
||||
Stockholders’ equity:
|
|
|
||||
Preferred shares, $0.001 par value;
|
|
|
||||
5,000,000 preferred shares authorized and none outstanding as of September 30, 2018 and December 31, 2017
|
—
|
|
—
|
|
||
Common stock, $0.001 par value;
|
|
|
||||
75,000,000 common shares authorized with 54,196,876 shares issued and outstanding on September 30, 2018 and 75,000,000 common shares authorized with 55,673,810 shares issued and outstanding on December 31, 2017
|
54
|
|
56
|
|
||
Contributed capital
|
430,734
|
|
360,620
|
|
||
Treasury Stock
|
(45,067
|
)
|
—
|
|
||
Accumulated deficit
|
(308,156
|
)
|
(241,972
|
)
|
||
Accumulated other comprehensive loss
|
(159
|
)
|
—
|
|
||
Total stockholders’ equity
|
77,406
|
|
118,704
|
|
||
Total liabilities and stockholders’ equity
|
$
|
200,656
|
|
$
|
125,512
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||
|
September 30,
|
September 30,
|
|
September 30,
|
September 30,
|
||||||||
|
2018
|
2017
|
|
2018
|
2017
|
||||||||
Net sales
|
$
|
1,355
|
|
$
|
828
|
|
|
$
|
3,848
|
|
$
|
2,058
|
|
|
|
|
|
|
|
||||||||
Cost of sales
|
680
|
|
191
|
|
|
1,889
|
|
352
|
|
||||
Gross profit
|
675
|
|
637
|
|
|
1,959
|
|
1,706
|
|
||||
|
|
|
|
|
|
||||||||
Costs and expenses:
|
|
|
|
|
|
||||||||
Research and development
|
7,891
|
|
6,351
|
|
|
20,734
|
|
16,166
|
|
||||
Sales, general and administrative
|
12,153
|
|
11,601
|
|
|
41,835
|
|
33,589
|
|
||||
Total costs and expenses
|
20,044
|
|
17,952
|
|
|
62,569
|
|
49,755
|
|
||||
|
|
|
|
|
|
||||||||
Loss from operations
|
(19,369
|
)
|
(17,315
|
)
|
|
(60,610
|
)
|
(48,049
|
)
|
||||
|
|
|
|
|
|
||||||||
Other income (expense):
|
|
|
|
|
|
||||||||
Interest expense
|
(3,357
|
)
|
—
|
|
|
(6,720
|
)
|
—
|
|
||||
Foreign currency exchange loss
|
(133
|
)
|
(40
|
)
|
|
(331
|
)
|
(73
|
)
|
||||
Interest income
|
908
|
|
323
|
|
|
1,983
|
|
612
|
|
||||
Other income (expense), net
|
—
|
|
2
|
|
|
(25
|
)
|
(3
|
)
|
||||
Total other income (expense), net
|
(2,582
|
)
|
285
|
|
|
(5,093
|
)
|
536
|
|
||||
|
|
|
|
|
|
||||||||
Net loss before income taxes
|
(21,951
|
)
|
(17,030
|
)
|
|
(65,703
|
)
|
(47,513
|
)
|
||||
Provision for income taxes
|
(147
|
)
|
(45
|
)
|
|
(432
|
)
|
(220
|
)
|
||||
Net loss
|
$
|
(22,098
|
)
|
$
|
(17,075
|
)
|
|
$
|
(66,135
|
)
|
$
|
(47,733
|
)
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share
|
$
|
(0.41
|
)
|
$
|
(0.31
|
)
|
|
$
|
(1.21
|
)
|
$
|
(0.89
|
)
|
Weighted average shares outstanding
|
54,145
|
|
55,316
|
|
|
54,591
|
|
53,603
|
|
||||
|
|
|
|
|
|
||||||||
Other comprehensive loss:
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(22,098
|
)
|
$
|
(17,075
|
)
|
|
$
|
(66,135
|
)
|
$
|
(47,733
|
)
|
Net unrealized (loss) gain on available-for-sale investments
|
1
|
|
(7
|
)
|
|
(54
|
)
|
(4
|
)
|
||||
Foreign currency translation adjustment
|
(26
|
)
|
91
|
|
|
(105
|
)
|
295
|
|
||||
Comprehensive loss
|
$
|
(22,123
|
)
|
$
|
(16,991
|
)
|
|
$
|
(66,294
|
)
|
$
|
(47,442
|
)
|
|
Nine Months Ended
|
|||||
|
September 30,
|
September 30,
|
||||
|
2018
|
2017
|
||||
Cash flows from operating activities:
|
|
|
||||
Net loss
|
$
|
(66,135
|
)
|
$
|
(47,733
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
||
Depreciation
|
1,734
|
|
1,595
|
|
||
Amortization of intangible assets
|
15
|
|
9
|
|
||
Amortization of investment discount
|
(413
|
)
|
298
|
|
||
Equity-based compensation
|
12,476
|
|
10,970
|
|
||
Amortization of debt discount and issuance costs
|
4,529
|
|
—
|
|
||
Loss on disposal of property and equipment
|
540
|
|
3
|
|
||
(Increase) decrease in assets:
|
|
|
|
|
||
Accounts receivable
|
506
|
|
(1,077
|
)
|
||
Inventory
|
(5,206
|
)
|
(7,079
|
)
|
||
Prepaid expense and other
|
55
|
|
(392
|
)
|
||
Other current assets
|
(26
|
)
|
(277
|
)
|
||
Other non-current assets
|
(241
|
)
|
—
|
|
||
Increase (decrease) in liabilities:
|
|
|
|
|
||
Accounts payable
|
(524
|
)
|
359
|
|
||
Accrued liabilities
|
(18
|
)
|
780
|
|
||
Accrued interest
|
191
|
|
—
|
|
||
Deferred revenue and income
|
(918
|
)
|
46
|
|
||
Deferred compensation
|
5
|
|
—
|
|
||
Net cash used in operating activities
|
(53,430
|
)
|
(42,498
|
)
|
||
Cash flows from investing activities:
|
|
|
||||
Purchases of equipment
|
(842
|
)
|
(2,055
|
)
|
||
Purchases of available-for-sale securities
|
(115,634
|
)
|
(68,423
|
)
|
||
Sales of available-for-sale securities
|
3,000
|
|
9,522
|
|
||
Maturity of available-for-sale securities
|
74,496
|
|
30,049
|
|
||
Net cash used in investing activities
|
(38,980
|
)
|
(30,907
|
)
|
||
Cash flows from financing activities:
|
|
|
||||
Issuance of common stock net of issuance costs
|
447
|
|
83,741
|
|
||
Exercise of options and warrants
|
3,710
|
|
4,562
|
|
||
Proceeds from issuance of convertible note
|
171,500
|
|
—
|
|
||
Prepayment of forward stock repurchase transaction
|
(45,069
|
)
|
—
|
|
||
Payment of debt issuance costs
|
(4,992
|
)
|
—
|
|
||
Net cash provided by financing activities
|
125,596
|
|
88,303
|
|
||
Effect of exchange rate on cash
|
(77
|
)
|
289
|
|
||
Increase in cash and cash equivalents
|
33,109
|
|
15,187
|
|
||
Cash and cash equivalents, beginning of period
|
28,513
|
|
19,244
|
|
||
Cash and cash equivalents, end of period
|
$
|
61,622
|
|
$
|
34,431
|
|
Non-cash investing activities:
|
|
|
||||
Transfer of instruments from inventory to property and equipment
|
$
|
4,061
|
|
$
|
—
|
|
Supplemental cash flow information:
|
|
|
||||
Interest paid
|
$
|
2,001
|
|
$
|
—
|
|
Income taxes paid
|
$
|
435
|
|
$
|
—
|
|
•
|
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
|
•
|
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).
|
|
Three Months Ended
|
Nine Months Ended
|
||||||||||
|
September 30,
|
September 30,
|
September 30,
|
September 30,
|
||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||
Beginning balance
|
$
|
199
|
|
$
|
61
|
|
$
|
192
|
|
$
|
1
|
|
Provisions
|
128
|
|
62
|
|
394
|
|
143
|
|
||||
Warranty incurred
|
(138
|
)
|
(34
|
)
|
(397
|
)
|
(55
|
)
|
||||
Ending balance
|
$
|
189
|
|
$
|
89
|
|
$
|
189
|
|
$
|
89
|
|
•
|
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
|
|
September 30, 2018
|
|||||||||||
|
Quoted Prices
in Active Markets for Identical Assets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
Total
|
||||||||
Assets:
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
||||||||
Money market funds
|
$
|
27,160
|
|
$
|
—
|
|
$
|
—
|
|
$
|
27,160
|
|
Commercial paper
|
—
|
|
2,644
|
|
—
|
|
2,644
|
|
||||
Asset-backed securities
|
—
|
|
3,001
|
|
—
|
|
3,001
|
|
||||
Total cash and cash equivalents
|
$
|
27,160
|
|
$
|
5,645
|
|
$
|
—
|
|
$
|
32,805
|
|
Investments:
|
|
|
|
|
||||||||
Certificates of deposit
|
—
|
|
12,481
|
|
—
|
|
12,481
|
|
||||
U.S. Treasury securities
|
34,268
|
|
—
|
|
—
|
|
34,268
|
|
||||
U.S. Agency securities
|
—
|
|
7,951
|
|
—
|
|
7,951
|
|
||||
Commercial paper
|
—
|
|
18,456
|
|
—
|
|
18,456
|
|
||||
Asset-backed securities
|
—
|
|
11,967
|
|
—
|
|
11,967
|
|
||||
Corporate notes and bonds
|
—
|
|
33,859
|
|
—
|
|
33,859
|
|
||||
Total investments
|
34,268
|
|
84,714
|
|
—
|
|
118,982
|
|
||||
Total assets measured at fair value
|
$
|
61,428
|
|
$
|
90,359
|
|
$
|
—
|
|
$
|
151,787
|
|
|
December 31, 2017
|
|||||||||||
|
Quoted Prices
in Active Markets for Identical Assets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
Total
|
||||||||
Assets:
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
||||||||
Money market funds
|
$
|
7,832
|
|
$
|
—
|
|
$
|
—
|
|
$
|
7,832
|
|
Investments:
|
|
|
|
|
||||||||
Certificates of deposit
|
—
|
|
13,441
|
|
—
|
|
13,441
|
|
||||
U.S. Treasury securities
|
14,716
|
|
—
|
|
—
|
|
14,716
|
|
||||
U.S. Agency securities
|
—
|
|
8,459
|
|
—
|
|
8,459
|
|
||||
Commercial paper
|
—
|
|
9,171
|
|
—
|
|
9,171
|
|
||||
Asset-backed securities
|
—
|
|
3,025
|
|
—
|
|
3,025
|
|
||||
Corporate notes and bonds
|
—
|
|
31,836
|
|
—
|
|
31,836
|
|
||||
Total investments
|
14,716
|
|
65,932
|
|
—
|
|
80,648
|
|
||||
Total assets measured at fair value
|
$
|
22,548
|
|
$
|
65,932
|
|
$
|
—
|
|
$
|
88,480
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||
|
September 30,
|
|
September 30,
|
||
|
2018
|
2017
|
|
2018
|
2017
|
Company A
|
17%
|
*
|
|
*
|
*
|
Company B
|
18%
|
*
|
|
*
|
*
|
Company C
|
20%
|
*
|
|
*
|
*
|
Company D
|
*
|
10%
|
|
*
|
22%
|
Company E
|
*
|
12%
|
|
*
|
*
|
Company F
|
*
|
16%
|
|
*
|
*
|
Company G
|
*
|
19%
|
|
*
|
*
|
Company H
|
*
|
20%
|
|
*
|
15%
|
|
September 30, 2018
|
|||||||||||
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
||||||||
Certificates of deposit
|
$
|
12,481
|
|
$
|
—
|
|
$
|
—
|
|
$
|
12,481
|
|
U.S. Treasury securities
|
34,390
|
|
—
|
|
(122
|
)
|
34,268
|
|
||||
U.S. Agency securities
|
8,017
|
|
—
|
|
(66
|
)
|
7,951
|
|
||||
Commercial paper
|
18,456
|
|
—
|
|
—
|
|
18,456
|
|
||||
Asset-backed securities
|
11,968
|
|
—
|
|
(1
|
)
|
11,967
|
|
||||
Corporate notes and bonds
|
33,916
|
|
2
|
|
(59
|
)
|
33,859
|
|
||||
Total
|
$
|
119,228
|
|
$
|
2
|
|
$
|
(248
|
)
|
$
|
118,982
|
|
|
December 31, 2017
|
|||||||||||
|
Amortized
Cost |
Gross
Unrealized Gains |
Gross
Unrealized Losses |
Fair Value
|
||||||||
Certificates of deposit
|
$
|
13,441
|
|
$
|
—
|
|
$
|
—
|
|
$
|
13,441
|
|
U.S. Treasury securities
|
14,787
|
|
—
|
|
(71
|
)
|
14,716
|
|
||||
U.S. Agency securities
|
8,510
|
|
—
|
|
(51
|
)
|
8,459
|
|
||||
Commercial paper
|
9,171
|
|
—
|
|
—
|
|
9,171
|
|
||||
Asset-backed securities
|
3,026
|
|
—
|
|
(1
|
)
|
3,025
|
|
||||
Corporate notes and bonds
|
31,906
|
|
—
|
|
(70
|
)
|
31,836
|
|
||||
Total
|
$
|
80,841
|
|
$
|
—
|
|
$
|
(193
|
)
|
$
|
80,648
|
|
|
September 30, 2018
|
December 31, 2017
|
||||||||||
|
Amortized
Cost |
Fair Value
|
Amortized
Cost |
Fair Value
|
||||||||
Due in less than 1 year
|
$
|
93,971
|
|
$
|
93,825
|
|
$
|
55,801
|
|
$
|
55,735
|
|
Due in 1-3 years
|
25,257
|
|
25,157
|
|
25,040
|
|
24,913
|
|
||||
Total
|
$
|
119,228
|
|
$
|
118,982
|
|
$
|
80,841
|
|
$
|
80,648
|
|
|
September 30,
|
December 31,
|
||||
|
2018
|
2017
|
||||
Raw materials
|
$
|
4,819
|
|
$
|
4,220
|
|
Work in process
|
1,144
|
|
377
|
|
||
Finished goods
|
3,443
|
|
3,466
|
|
||
Inventory
|
$
|
9,406
|
|
$
|
8,063
|
|
|
September 30,
|
December 31,
|
||||
|
2018
|
2017
|
||||
Computer equipment
|
$
|
2,801
|
|
$
|
2,756
|
|
Technical equipment
|
3,820
|
|
3,348
|
|
||
Facilities
|
4,006
|
|
3,621
|
|
||
Instruments
|
4,821
|
|
1,400
|
|
||
Capital projects in progress
|
107
|
|
349
|
|
||
Total property and equipment
|
$
|
15,555
|
|
$
|
11,474
|
|
Accumulated depreciation
|
(8,143
|
)
|
(6,584
|
)
|
||
Property and equipment, net
|
$
|
7,412
|
|
$
|
4,890
|
|
•
|
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
.
|
|
September 30,
|
December 31,
|
||||
|
2018
|
2017
|
||||
Products and services not yet delivered
|
$
|
202
|
|
$
|
71
|
|
Arizona Commerce Authority grant
|
—
|
|
1,000
|
|
||
Deferred revenue and income
|
$
|
202
|
|
$
|
1,071
|
|
•
|
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.
|
|
September 30,
|
December 31,
|
||
|
2018
|
2017
|
||
Shares issuable upon the release of restricted stock awards
|
66
|
|
24
|
|
Shares issuable upon exercise of stock options
|
8,182
|
|
7,328
|
|
|
8,248
|
|
7,352
|
|
|
Number of Shares
|
Weighted Average Exercise Price per Share
|
|||
Options Outstanding January 1, 2018
|
7,328,131
|
|
$
|
10.16
|
|
Granted
|
1,355,371
|
|
24.70
|
|
|
Forfeited
|
(131,226
|
)
|
21.35
|
|
|
Exercised
|
(351,626
|
)
|
10.55
|
|
|
Expired
|
(18,266
|
)
|
24.24
|
|
|
Options Outstanding September 30, 2018
|
8,182,384
|
|
$
|
12.34
|
|
|
Three Months Ended
|
|||||
|
September 30,
|
September 30,
|
||||
|
2018
|
2017
|
||||
Expected term (in years)
|
5.53
|
|
6.46
|
|
||
Volatility
|
58
|
%
|
74
|
%
|
||
Expected dividends
|
—
|
|
—
|
|
||
Risk free interest rates
|
2.75
|
%
|
2.02
|
%
|
||
Weighted average fair value
|
$
|
11.48
|
|
$
|
15.74
|
|
|
Options
Outstanding
|
Options
Exercisable
|
||||
Number of options
|
8,182,384
|
|
5,751,558
|
|
||
Weighted average remaining contractual term (in years)
|
6.05
|
|
4.95
|
|
||
Weighted average exercise price
|
$
|
12.34
|
|
$
|
8.26
|
|
Weighted average fair value
|
$
|
8.57
|
|
$
|
5.83
|
|
Aggregate intrinsic value (in thousands)
|
$
|
91,273
|
|
$
|
85,694
|
|
|
Number of Shares
|
Weighted Average Grant Date Fair Value per Share
|
|||
Outstanding January 1, 2018
|
24,150
|
|
$
|
26.45
|
|
Granted
|
50,000
|
|
20.80
|
|
|
Forfeited
|
—
|
|
—
|
|
|
Vested/released
|
(8,050
|
)
|
26.45
|
|
|
Outstanding September 30, 2018
|
66,100
|
|
22.18
|
|
|
Three Months Ended
|
Nine Months Ended
|
||||||||||
|
September 30,
|
September 30,
|
September 30,
|
September 30,
|
||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||
Cost of sales
|
$
|
68
|
|
$
|
22
|
|
$
|
172
|
|
$
|
44
|
|
Research and development
|
1,476
|
|
994
|
|
3,926
|
|
2,886
|
|
||||
Sales, general and administrative
|
1,921
|
|
2,504
|
|
8,378
|
|
8,040
|
|
||||
Equity-based compensation expense
|
$
|
3,465
|
|
$
|
3,520
|
|
$
|
12,476
|
|
$
|
10,970
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||
|
September 30,
|
|
September 30,
|
||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||
|
2018
|
2017
|
|
2018
|
2017
|
||||||||
Primary Geographic Markets:
|
|
|
|
|
|
||||||||
Domestic
|
$
|
1,172
|
|
$
|
507
|
|
|
$
|
2,988
|
|
$
|
1,569
|
|
Foreign
|
183
|
|
321
|
|
|
860
|
|
489
|
|
||||
Net sales
|
$
|
1,355
|
|
$
|
828
|
|
|
$
|
3,848
|
|
$
|
2,058
|
|
|
|
|
|
|
|
||||||||
Line of Business:
|
|
|
|
|
|
||||||||
Accelerate Pheno™ revenue
|
$
|
1,325
|
|
$
|
803
|
|
|
$
|
3,760
|
|
$
|
1,983
|
|
Other revenue
|
30
|
|
25
|
|
|
88
|
|
75
|
|
||||
Net sales
|
$
|
1,355
|
|
$
|
828
|
|
|
$
|
3,848
|
|
$
|
2,058
|
|
|
|
|
|
|
|
||||||||
Products and Services:
|
|
|
|
|
|
||||||||
Products
|
$
|
1,331
|
|
$
|
820
|
|
|
$
|
3,798
|
|
$
|
2,044
|
|
Services
|
24
|
|
8
|
|
|
50
|
|
14
|
|
||||
Net sales
|
$
|
1,355
|
|
$
|
828
|
|
|
$
|
3,848
|
|
$
|
2,058
|
|
|
September 30,
|
December 31,
|
||||
|
2018
|
2017
|
||||
Domestic
|
$
|
6,195
|
|
$
|
3,779
|
|
Foreign
|
1,217
|
|
1,111
|
|
||
Property and equipment, net
|
$
|
7,412
|
|
$
|
4,890
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||||
Cost of sales
|
$
|
680
|
|
$
|
191
|
|
$
|
489
|
|
256
|
%
|
|
$
|
1,889
|
|
$
|
352
|
|
$
|
1,537
|
|
437
|
%
|
Gross profit
|
$
|
675
|
|
$
|
637
|
|
$
|
38
|
|
6
|
%
|
|
$
|
1,959
|
|
$
|
1,706
|
|
$
|
253
|
|
15
|
%
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||||
Sales, general and administrative
|
$
|
12,153
|
|
$
|
11,601
|
|
$
|
552
|
|
5
|
%
|
|
$
|
41,835
|
|
$
|
33,589
|
|
$
|
8,246
|
|
25
|
%
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||||||||||
|
September 30,
|
|
September 30,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||||
Total other income (expense), net
|
$
|
(2,582
|
)
|
$
|
285
|
|
$
|
(2,867
|
)
|
(1,006
|
)%
|
|
$
|
(5,093
|
)
|
$
|
536
|
|
$
|
(5,629
|
)
|
(1,050
|
)%
|
Cash Flow Summary
(in thousands) |
|||||||||
|
Nine Months Ended
|
|
|||||||
|
September 30,
|
September 30,
|
Change
|
||||||
|
2018
|
2017
|
|||||||
Net cash used in operating activities
|
$
|
(53,430
|
)
|
$
|
(42,498
|
)
|
$
|
(10,932
|
)
|
Net cash used in investing activities
|
(38,980
|
)
|
(30,907
|
)
|
(8,073
|
)
|
|||
Net cash provided by financing activities
|
125,596
|
|
88,303
|
|
37,293
|
|
•
|
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.
|
Exhibit No.
|
Description
|
Filing 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 to the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012, filed on October 26, 2012
|
||
Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on November 16, 2017
|
||
10.9.5
*
|
Incorporated by reference to Appendix A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed on April 10, 2017
|
|
10.9.6
*
|
Filed herewith
|
|
10.9.7
*
|
Filed herewith
|
|
Filed herewith
|
||
Filed herewith
|
||
Furnished 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
|
|
November 6, 2018
|
/s/ Lawrence Mehren
|
|
Lawrence Mehren
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
November 6, 2018
|
/s/ Steve Reichling
|
|
Steve Reichling
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
ACCELERATE DIAGNOSTICS, INC.
|
/s/ Steve Reichling
|
Steve Reichling
Chief Financial Officer
|
1.
|
Purpose
. The primary purpose of this Sub-Plan is to amend those provisions of the Plan which are required to be amended in order for awards made under the Plan, and communications concerning those awards, to be exempt from provisions of the United Kingdom Financial Services and Markets Act 2000 (the “
FSMA
”).
|
2.
|
Application
. This Sub-Plan shall be used solely to grant awards to employees of the Company or any member of the same Group as the Company resident and providing services in the United Kingdom. For this purpose, the term “
Group
” in relation to the Company shall have the meaning given to such term in Section 421 of the FSMA.
|
3.
|
Restricted Delivery of Awards
.
The settlement of awards under this Sub-Plan shall be made only in shares of Stock or such other securities of the Company that may arise from such shares of Stock under the adjustment provisions of the Plan. For the avoidance of doubt, and without limitation, no cash settlement of awards (including dividends or dividend equivalent payments in cash) shall be permissible.
|
4.
|
Exercise of Options/Vesting of Awards
. The Administrator may specify, in its discretion, any other conditions of exercise and/or vesting of awards that will be specified in the Award Agreement.
|
5.
|
Restricted Transfer of Rights
. The persons to whom rights under any award may be assigned or transferred, whether by will or the laws of descent and distribution or the transferability of awards shall be limited to a Participant's children and step-children under the age of eighteen, spouses and surviving spouses and civil partners and civil partners (within the meaning of the United Kingdom Civil Partnerships Act 2004) and surviving partners.
|
6.
|
Tax
.
All awards will be subject to tax withholding but, for the purposes of this Sub-Plan, references to “tax” shall be read and construed as including, without limitation, United Kingdom income tax and primary class 1 (employee’s) national insurance contributions that the Participant’s employer is liable to account for and, if so agreed between the Company and the Participant, secondary class 1 (employer’s) national insurance contributions that the Participant’s employer is liable to account for.
|
7.
|
Incorporation of Plan Provisions
. The provisions of the Plan shall apply to all awards made under this Sub-Plan and shall accordingly be deemed to be incorporated herein, save as varied by the terms of this Sub-Plan.
|
ACCELERATE DIAGNOSTICS, INC.
|
/s/ Steve Reichling
|
Steve Reichling
Chief Financial Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Accelerate Diagnostics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
November 6, 2018
|
/s/ Lawrence Mehren
|
|
Lawrence Mehren
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Accelerate Diagnostics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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November 6, 2018
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/s/
Steve Reichling
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Steve Reichling
Chief Financial Officer
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(Principal Financial and Accounting Officer)
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November 6, 2018
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/s/ Lawrence Mehren
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Lawrence Mehren
President and Chief Executive Officer
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(Principal Executive Officer)
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November 6, 2018
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/s/ Steve Reichling
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Steve Reichling
Chief Financial Officer
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(Principal Financial and Accounting Officer)
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