Delaware
|
84-1072256
|
(State or other jurisdiction of
|
(I.R.S. Employer Identification No.)
|
incorporation or organization)
|
|
|
|
3950 South Country Club Road, Suite 470
|
|
Tucson, Arizona
|
85714
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value per share
|
The Nasdaq Stock Market LLC
(The Nasdaq Capital Market)
|
Large accelerated filer
|
|
þ
|
Accelerated filer
|
|
o
|
Non-accelerated file
|
|
o
|
Smaller reporting company
|
|
þ
|
Emerging growth company
|
|
o
|
•
|
In June 2012, the Company raised $14.4 million through the sale of common stock to Abeja Ventures, LLC.
|
•
|
In March 2013, the Company obtained additional capital through the exercise of warrants issued to Abeja Ventures, LLC in the aggregate amount of
$20.1 million
.
|
•
|
In August 2013, the Company completed a rights offering that raised gross proceeds of $20.0 million.
|
•
|
In April 2014, the Company completed a rights offering that raised gross proceeds of
$45.0 million
.
|
•
|
In December 2015, the Company completed a publicly marketed common stock offering that raised gross proceeds of
$109.3 million
.
|
•
|
In May 2017, the Company completed another publicly marketed common stock offering that raised additional gross proceeds of
$89.0 million
.
|
•
|
In March 2018, the Company completed a convertible debt offering providing additional gross proceeds of
$171.5 million
.
|
•
|
Automated specimen preparation.
The initial step in the process is the automated purification of samples through an on-board and proprietary process to separate live organisms from sample debris.
|
•
|
Live-cell immobilization.
Following preparation, the purified sample is moved to the imaging cassette where pathogens are immobilized onto the cassette surface such that they can be imaged and analyzed in a stationary position during the identification and antibiotic susceptibility testing.
|
•
|
Identification testing via fluorescent in situ hybridization (FISH).
The now immobilized cells are tested with our proprietary FISH probes to enable identification. Because the genetic sequences of bacteria are distinctive, the binding of fluorescently labeled probes indicates the presence of a specific target sequence of RNA associated with a single or group of bacterial species or yeasts. When the probe finds a targeted sequence, it binds to it—generating a fluorescent signal—which is visible by the imaging system on the Accelerate Pheno™ system. Positive fluorescent signals from more than one target probe indicate polymicrobial samples and a universal bacterial stain discriminates target from non-target bacteria or fungi. The identification result is presented on the Accelerate Pheno™ system's graphic user interface in approximately 90 minutes from the introduction of the sample into the Accelerate Pheno™ system.
|
•
|
Susceptibility testing via live-cell optical analysis.
With the identification of the pathogen known, the system’s software determines the antibiotic panel to be used for susceptibility testing. These antibiotics, growth media, and additional patient sample are introduced to additional channels on the optical cassette. Finally, our proprietary imaging platform and algorithms determine the minimum inhibitory concentration of the bacteria by observing which antibiotics arrested live cell growth and led to cell death and which antibiotics were ineffective in ceasing live cell growth. The susceptibility test result is presented approximately five hours after the conclusion of the identification test.
|
•
|
design, development, manufacturing, and storage;
|
•
|
testing, content, and language of instructions for use and storage;
|
•
|
labeling;
|
•
|
pre-clinical testing and clinical trials;
|
•
|
product safety;
|
•
|
advertising, promotion, marketing, sales, and distribution;
|
•
|
pre-market clearance and approval;
|
•
|
record-keeping procedures;
|
•
|
advertising and promotion;
|
•
|
recalls and corrective field actions;
|
•
|
post-market reporting, including reporting of deaths, serious injuries, and malfunctions that, if they were to recur, could lead to death or serious injury;
|
•
|
post-market studies and surveillance; and
|
•
|
product import and export.
|
•
|
the QSR, which imposes elaborate development, testing, control, documentation, and other quality assurance requirements on the design and manufacturing process;
|
•
|
establishment registration, which requires establishments involved in the production and distribution of medical devices, intended for commercial distribution in the United States, to register with the FDA;
|
•
|
medical device listing, which requires manufacturers to list the devices they have in commercial distribution with the FDA;
|
•
|
labeling regulations and various statutory provisions, which prohibit false or misleading labeling, as well as the promotion of products for unapproved or
“
off-label
”
uses, and impose other restrictions on labeling;
|
•
|
post-market reporting requirements, which require that manufacturers report to the FDA deaths, serious injuries, and malfunctions that, if they were to recur, could lead to death or serious injury, recalls, and corrective field actions.
|
•
|
untitled letters or warning letters;
|
•
|
fines, injunctions, and civil penalties;
|
•
|
mandatory recall or seizure of our products;
|
•
|
administrative detention or banning of our products;
|
•
|
operating restrictions, partial suspension, or total shutdown of production;
|
•
|
import holds;
|
•
|
refusing to approve pending 510(k) notifications or PMAs;
|
•
|
revocation of 510(k) clearance or pre-market approvals previously granted; and
|
•
|
criminal prosecution and penalties.
|
•
|
the expenses we incur for research and development required to maintain and improve our technology, including the continuing development of the Accelerate Pheno™ system;
|
•
|
the expenses we incur in connection with the development, marketing authorization and regulatory clearance of the use of the Accelerate Pheno™ system to test on additional specimen types;
|
•
|
the costs of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property related costs, including litigation costs and the results of such litigation;
|
•
|
the expenses we incur in connection with commercialization activities, including product marketing, sales and distribution expenses;
|
•
|
the costs incurred to build manufacturing capabilities;
|
•
|
the expenses to implement our sales strategy;
|
•
|
the costs to attract and retain personnel with the skills required for effective operations; and
|
•
|
the costs associated with being a public company.
|
•
|
required compliance with existing and changing foreign healthcare and other regulatory requirements and laws, such as those relating to patient privacy or handling of bio-hazardous waste;
|
•
|
required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act, data privacy requirements, labor laws and anti-competition regulations;
|
•
|
export and import restrictions;
|
•
|
various reimbursement and insurance regimes;
|
•
|
laws and business practices favoring local companies;
|
•
|
longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
|
•
|
political and economic instability;
|
•
|
potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;
|
•
|
foreign exchange controls;
|
•
|
fluctuations due to changes in foreign currency exchange rates;
|
•
|
difficulties and costs of staffing and managing foreign operations; and
|
•
|
impediments with protecting or procuring intellectual property rights.
|
•
|
changes in pre-tax income in various jurisdictions in which we operate that have differing statutory tax rates;
|
•
|
increases in corporate tax rates and the availability of deductions or credits in the United States and elsewhere;
|
•
|
changes in tax laws, regulations, and/or interpretations of such tax laws in multiple jurisdictions, including but not limited to U.S. federal and state regulations or interpretations resulting from the Tax Cuts and Jobs Act of 2017;
|
•
|
tax effects related to purchase accounting for acquisitions; and
|
•
|
resolutions of issues arising from tax examinations and any related interest or penalties.
|
•
|
reliance on third parties for regulatory compliance and quality assurance;
|
•
|
possible breaches of manufacturing agreements by the third parties because of factors beyond our control;
|
•
|
possible regulatory violations or manufacturing problems experienced by our suppliers;
|
•
|
possible termination or non-renewal of agreements by third parties, based on their own business priorities, at times that are costly or inconvenient for us;
|
•
|
the potential obsolescence and/or inability of our suppliers to obtain required components;
|
•
|
the potential delays and expenses of seeking alternate sources of supply or manufacturing services;
|
•
|
the inability to qualify alternate sources without impacting performance claims of our products;
|
•
|
reduced control over pricing, quality and timely delivery due to the difficulties in switching to alternate suppliers or assemblers; and
|
•
|
increases in prices of raw materials and key components.
|
•
|
The federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully offering, providing, soliciting, or receiving any remuneration, directly or indirectly, in exchange for or to induce the referral of an individual, or the purchasing, leasing, ordering, recommending, furnishing or arranging for a good or service, for which payment may be made under a federal health care program, such as Medicare or Medicaid.
|
•
|
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits knowingly and willfully (i) executing a scheme to defraud any health care benefit program, including private payers, or (ii) falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for items or services under a health care benefit program.
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, which also restricts the use and disclosure of protected health information, mandates the adoption of standards relating to the privacy and security of protected health information, and requires us to report certain security breaches to health care provider customers with respect to such information where we are acting as a HIPAA business associate to that customer.
|
•
|
The federal Physician Payment Sunshine Act, which requires manufacturers of certain medical devices to track payments or other transfers of value given to U.S. licensed physicians or teaching hospitals and to report this data to CMS annually for subsequent public disclosure.
|
•
|
The federal False Claims Act, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government and to share in any monetary recovery.
|
•
|
administrative or judicially imposed sanctions;
|
•
|
injunctions or the imposition of civil penalties;
|
•
|
recall or seizure of our products;
|
•
|
total or partial suspension of production or distribution;
|
•
|
withdrawal or suspension of marketing clearances or approvals;
|
•
|
clinical holds;
|
•
|
warning letters;
|
•
|
refusal to permit the import or export of our products;
|
•
|
criminal prosecution; and
|
•
|
exclusion or debarment from participation in federal health care programs such as Medicare and Medicaid.
|
•
|
we may not be able to demonstrate to the FDA’s satisfaction that our product candidates are safe and effective, sensitive and specific diagnostic tests, for their intended users;
|
•
|
the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; and
|
•
|
the manufacturing process or facilities we or our contract manufacturers use may not meet applicable requirements.
|
•
|
our ability to obtain marketing authorization from the FDA or clearance from the FDA to market our product candidates;
|
•
|
market acceptance of our product candidates, if cleared;
|
•
|
the cost and timing of establishing sales, marketing and distribution capabilities;
|
•
|
the cost of our research and development activities;
|
•
|
the ability of healthcare providers to obtain coverage and adequate reimbursement by third-party payers for procedures using our products;
|
•
|
the cost and timing of marketing authorization or regulatory clearances;
|
•
|
the cost of goods associated with our product candidates;
|
•
|
the cost of customer disruptions due to supply disruptions;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates, although we currently have no commitments or agreements to complete any such transactions.
|
•
|
heighten our vulnerability to adverse general economic conditions and heightened 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.
|
|
Dec-13
|
Dec-14
|
Dec-15
|
Dec-16
|
Dec-17
|
Dec-18
|
Accelerate Diagnostics, Inc.
|
100.00
|
157.30
|
176.15
|
170.08
|
214.75
|
94.26
|
NASDAQ Composite
|
100.00
|
114.75
|
122.74
|
133.62
|
173.22
|
168.30
|
NASDAQ Biotechnology
|
100.00
|
134.40
|
150.22
|
118.15
|
143.71
|
130.97
|
Equity Compensation Plan
|
|||||||
Plan category
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights
|
Weighted
-
average exercise price of outstanding options, warrants and rights
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in the 1st column)
|
||||
Equity compensation plans approved by security holders
|
8,166,636
|
|
$
|
12.11
|
|
2,198,095
|
|
Equity compensation plans not approved by security holders
|
—
|
|
—
|
|
—
|
|
|
Total
|
8,166,636
|
|
$
|
12.11
|
|
2,198,095
|
|
Selected Consolidated Financial Data
(in thousands except per share data)
|
|||||||||||||||
|
2018
|
2017
|
2016
|
2015
|
2014
|
||||||||||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
246
|
|
$
|
147
|
|
$
|
122
|
|
Loss from operations
|
(80,369
|
)
|
(64,184
|
)
|
(66,501
|
)
|
(45,549
|
)
|
(30,990
|
)
|
|||||
Net loss
|
(88,326
|
)
|
(64,028
|
)
|
(66,374
|
)
|
(45,498
|
)
|
(30,933
|
)
|
|||||
Basic and diluted loss per share (1)
|
(1.62
|
)
|
(1.18
|
)
|
(1.29
|
)
|
(1.01
|
)
|
(0.71
|
)
|
|||||
Cash dividends
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
2018
|
2017
|
2016
|
2015
|
2014
|
||||||||||
Total assets
|
$
|
185,265
|
|
$
|
125,512
|
|
$
|
82,852
|
|
$
|
139,324
|
|
$
|
69,801
|
|
Other long term liabilities
|
53
|
|
21
|
|
—
|
|
—
|
|
13
|
|
|||||
Long term debt
|
120,074
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
1,493
|
|
36
|
%
|
|
$
|
4,177
|
|
$
|
246
|
|
$
|
3,931
|
|
1,598
|
%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Cost of sales
|
$
|
3,187
|
|
$
|
1,002
|
|
$
|
2,185
|
|
218
|
%
|
|
$
|
1,002
|
|
$
|
—
|
|
$
|
1,002
|
|
—
|
%
|
Gross profit
|
$
|
2,483
|
|
$
|
3,175
|
|
$
|
(692
|
)
|
(22
|
)%
|
|
$
|
3,175
|
|
$
|
246
|
|
$
|
2,929
|
|
1,191
|
%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Research and development
|
$
|
27,638
|
|
$
|
22,301
|
|
$
|
5,337
|
|
24
|
%
|
|
$
|
22,301
|
|
$
|
29,564
|
|
$
|
(7,263
|
)
|
(25
|
)%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Sales, general and administrative
|
$
|
55,214
|
|
$
|
45,058
|
|
$
|
10,156
|
|
23
|
%
|
|
$
|
45,058
|
|
$
|
37,183
|
|
$
|
7,875
|
|
21
|
%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Loss from operations
|
$
|
(80,369
|
)
|
$
|
(64,184
|
)
|
$
|
(16,185
|
)
|
25
|
%
|
|
$
|
(64,184
|
)
|
$
|
(66,501
|
)
|
$
|
2,317
|
|
(3
|
)%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Total other income (expense), net
|
$
|
(7,746
|
)
|
$
|
649
|
|
$
|
(8,395
|
)
|
(1,294
|
)%
|
|
$
|
649
|
|
$
|
394
|
|
$
|
255
|
|
65
|
%
|
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
(in thousands)
|
|
(in thousands)
|
||||||||||||||||||||
|
2018
|
2017
|
$ Change
|
% Change
|
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||||
Provision for income taxes
|
$
|
(211
|
)
|
$
|
(493
|
)
|
$
|
282
|
|
(57
|
)%
|
|
$
|
(493
|
)
|
$
|
(267
|
)
|
$
|
(226
|
)
|
85
|
%
|
Cash Flow Summary
(in thousands) |
|||||||||
|
2018
|
2017
|
2016
|
||||||
Net cash used in operating activities
|
$
|
(67,756
|
)
|
$
|
(55,746
|
)
|
$
|
(53,408
|
)
|
Net cash used in investing activities
|
(20,138
|
)
|
(25,728
|
)
|
(49,568
|
)
|
|||
Net cash provided by financing activities
|
125,771
|
|
90,427
|
|
1,762
|
|
Payments due by Period
(in thousands)
|
||||||||||||||||||
Contractual Obligations
|
Total
|
2019
|
2020
|
2021
|
2022
|
2023
|
||||||||||||
Operating Lease Obligations
|
$
|
607
|
|
$
|
334
|
|
$
|
154
|
|
$
|
97
|
|
$
|
22
|
|
$
|
—
|
|
Convertible Notes
|
$
|
171,500
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
171,500
|
|
Total
|
$
|
172,107
|
|
$
|
334
|
|
$
|
154
|
|
$
|
97
|
|
$
|
22
|
|
$
|
171,500
|
|
•
|
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
|
•
|
Volatility: The expected volatility is based on the historical volatility of the Company's stock price over the most recent period commensurate with the expected term of the stock option award.
|
•
|
Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award.
|
•
|
Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term.
|
•
|
Dividend yield: The dividend yield is estimated as 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.
|
|
December 31,
|
|||||
|
2018
|
2017
|
||||
ASSETS
|
||||||
Current assets:
|
|
|
||||
Cash and cash equivalents
|
$
|
66,260
|
|
$
|
28,513
|
|
Investments
|
100,218
|
|
80,648
|
|
||
Trade accounts receivable
|
1,860
|
|
1,946
|
|
||
Inventory
|
7,746
|
|
8,063
|
|
||
Prepaid expenses
|
980
|
|
850
|
|
||
Other current assets
|
576
|
|
468
|
|
||
Total current assets
|
177,640
|
|
120,488
|
|
||
Property and equipment, net
|
7,303
|
|
4,890
|
|
||
Intellectual property, net
|
114
|
|
134
|
|
||
Other non-current assets
|
208
|
|
—
|
|
||
Total assets
|
$
|
185,265
|
|
$
|
125,512
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||
Current liabilities:
|
|
|
||||
Accounts payable
|
$
|
1,322
|
|
$
|
2,080
|
|
Accrued liabilities
|
4,962
|
|
3,636
|
|
||
Accrued Interest
|
1,262
|
|
—
|
|
||
Deferred revenue and income
|
217
|
|
1,071
|
|
||
Total current liabilities
|
7,763
|
|
6,787
|
|
||
Other long term liabilities
|
53
|
|
21
|
|
||
Convertible notes
|
120,074
|
|
—
|
|
||
Total liabilities
|
127,890
|
|
6,808
|
|
||
|
|
|
||||
Commitments and contingencies
|
|
|
|
|
||
|
|
|
||||
Stockholders' equity:
|
|
|
||||
Preferred shares, $0.001 par value;
|
|
|
||||
5,000,000 preferred shares authorized and none outstanding as of December 31, 2018 and 2017
|
—
|
|
—
|
|
||
Common stock, $0.001 par value;
|
|
|
||||
75,000,000 common shares authorized with 54,231,876 shares issued and outstanding on December 31, 2018 and 75,000,000 authorized with 55,673,810 shares issued and outstanding on December 31, 2017
|
54
|
|
56
|
|
||
Contributed capital
|
432,885
|
|
360,620
|
|
||
Treasury stock
|
(45,067
|
)
|
—
|
|
||
Accumulated deficit
|
(330,348
|
)
|
(241,972
|
)
|
||
Accumulated other comprehensive (loss)
|
(149
|
)
|
—
|
|
||
Total stockholders' equity
|
57,375
|
|
118,704
|
|
||
Total liabilities and stockholders' equity
|
$
|
185,265
|
|
$
|
125,512
|
|
|
Years Ended December 31,
|
||||||||
|
2018
|
2017
|
2016
|
||||||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
246
|
|
|
|
|
|
|
|
|
|||
Cost of sales
|
3,187
|
|
1,002
|
|
—
|
|
|||
Gross profit
|
2,483
|
|
3,175
|
|
246
|
|
|||
|
|
|
|
||||||
Costs and expenses:
|
|
|
|
|
|
|
|||
Research and development
|
27,638
|
|
22,301
|
|
29,564
|
|
|||
Sales, general and administrative
|
55,214
|
|
45,058
|
|
37,183
|
|
|||
Total costs and expenses
|
82,852
|
|
67,359
|
|
66,747
|
|
|||
|
|
|
|
||||||
Loss from operations
|
(80,369
|
)
|
(64,184
|
)
|
(66,501
|
)
|
|||
|
|
|
|
||||||
Other income (expense):
|
|
|
|
||||||
Interest expense
|
(10,113
|
)
|
—
|
|
—
|
|
|||
Foreign currency exchange loss
|
(450
|
)
|
(75
|
)
|
(77
|
)
|
|||
Interest and dividend income
|
2,845
|
|
908
|
|
494
|
|
|||
Other expense, net
|
(28
|
)
|
(184
|
)
|
(23
|
)
|
|||
Total other income (expense), net
|
(7,746
|
)
|
649
|
|
394
|
|
|||
|
|
|
|
||||||
Net loss before income taxes
|
(88,115
|
)
|
(63,535
|
)
|
(66,107
|
)
|
|||
Provision for income taxes
|
(211
|
)
|
(493
|
)
|
(267
|
)
|
|||
Net loss
|
$
|
(88,326
|
)
|
$
|
(64,028
|
)
|
$
|
(66,374
|
)
|
|
|
|
|
||||||
Basic and diluted net loss per share
|
$
|
(1.62
|
)
|
$
|
(1.18
|
)
|
$
|
(1.29
|
)
|
Weighted average shares outstanding
|
54,494
|
|
54,073
|
|
51,276
|
|
|||
|
|
|
|
||||||
Other comprehensive loss:
|
|
|
|
||||||
Net loss
|
$
|
(88,326
|
)
|
$
|
(64,028
|
)
|
$
|
(66,374
|
)
|
Net unrealized gain (loss) on available-for-sale investments
|
23
|
|
(117
|
)
|
(64
|
)
|
|||
Foreign currency translation adjustment
|
(172
|
)
|
321
|
|
(128
|
)
|
|||
Comprehensive loss
|
$
|
(88,475
|
)
|
$
|
(63,824
|
)
|
$
|
(66,566
|
)
|
|
Shares
|
Common
Stock Amount |
Contributed
Capital |
Accumulated Deficit
|
Treasury
stock |
Accumulated
Other Comprehensive Income (Loss) |
Total
Stockholders’ Equity |
|||||||||||||
Balances, January 1, 2016
|
51,191
|
|
$
|
51
|
|
$
|
243,894
|
|
$
|
(110,915
|
)
|
$
|
—
|
|
$
|
(12
|
)
|
$
|
133,018
|
|
Net loss
|
—
|
|
—
|
|
—
|
|
(66,374
|
)
|
—
|
|
—
|
|
(66,374
|
)
|
||||||
Exercise of options and warrants
|
314
|
|
1
|
|
1,496
|
|
—
|
|
—
|
|
—
|
|
1,497
|
|
||||||
Issuance of common stock under employee purchase plan
|
11
|
|
—
|
|
226
|
|
—
|
|
—
|
|
—
|
|
226
|
|
||||||
Short swing profits (net of costs)
|
—
|
|
—
|
|
866
|
|
—
|
|
—
|
|
—
|
|
866
|
|
||||||
Unrealized loss on available-for-sale securities
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(64
|
)
|
(64
|
)
|
||||||
Foreign currency translation adjustment
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(128
|
)
|
(128
|
)
|
||||||
Equity-based compensation
|
—
|
|
—
|
|
8,775
|
|
—
|
|
—
|
|
—
|
|
8,775
|
|
||||||
Balances, December 31, 2016
|
51,516
|
|
52
|
|
255,257
|
|
(177,289
|
)
|
—
|
|
(204
|
)
|
77,816
|
|
||||||
Net loss
|
—
|
|
—
|
|
—
|
|
(64,028
|
)
|
—
|
|
—
|
|
(64,028
|
)
|
||||||
Issuance of common stock
|
3,085
|
|
3
|
|
83,221
|
|
—
|
|
—
|
|
—
|
|
83,224
|
|
||||||
Exercise of options and warrants
|
1,045
|
|
1
|
|
6,605
|
|
—
|
|
—
|
|
—
|
|
6,606
|
|
||||||
Issuance of common stock under employee purchase plan
|
28
|
|
—
|
|
597
|
|
—
|
|
—
|
|
—
|
|
597
|
|
||||||
Unrealized loss on available-for-sale securities
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(117
|
)
|
(117
|
)
|
||||||
Foreign currency translation adjustment
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
321
|
|
321
|
|
||||||
Cumulative impact of accounting change
|
—
|
|
—
|
|
—
|
|
(655
|
)
|
—
|
|
—
|
|
(655
|
)
|
||||||
Equity-based compensation
|
—
|
|
—
|
|
14,940
|
|
—
|
|
—
|
|
—
|
|
14,940
|
|
||||||
Balances, December 31, 2017
|
55,674
|
|
56
|
|
360,620
|
|
(241,972
|
)
|
—
|
|
—
|
|
118,704
|
|
||||||
Net loss
|
—
|
|
—
|
|
—
|
|
(88,326
|
)
|
—
|
|
—
|
|
(88,326
|
)
|
||||||
Exercise of options and restricted stock awards issued
|
382
|
|
—
|
|
3,749
|
|
—
|
|
—
|
|
—
|
|
3,749
|
|
||||||
Issuance of common stock under employee purchase plan
|
35
|
|
—
|
|
583
|
|
—
|
|
—
|
|
—
|
|
583
|
|
||||||
Unrealized loss on available-for-sale securities
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
23
|
|
23
|
|
||||||
Foreign currency translation adjustment
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(172
|
)
|
(172
|
)
|
||||||
Repurchase of common stock under Prepaid Forward contract
|
(1,859
|
)
|
(2
|
)
|
—
|
|
—
|
|
(45,067
|
)
|
—
|
|
(45,069
|
)
|
||||||
Issuance of convertible note
|
—
|
|
—
|
|
53,283
|
|
—
|
|
—
|
|
—
|
|
53,283
|
|
||||||
Cumulative impact of accounting change
|
—
|
|
—
|
|
—
|
|
(50
|
)
|
—
|
|
—
|
|
(50
|
)
|
||||||
Equity-based compensation
|
—
|
|
—
|
|
14,650
|
|
—
|
|
—
|
|
—
|
|
14,650
|
|
||||||
Balances, December 31, 2018
|
54,232
|
|
$
|
54
|
|
$
|
432,885
|
|
$
|
(330,348
|
)
|
$
|
(45,067
|
)
|
$
|
(149
|
)
|
$
|
57,375
|
|
|
Years Ended December 31,
|
||||||||
|
2018
|
2017
|
2016
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|||||
Net loss
|
$
|
(88,326
|
)
|
$
|
(64,028
|
)
|
$
|
(66,374
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|||
Depreciation and amortization
|
2,561
|
|
2,196
|
|
2,351
|
|
|||
Amortization of investment discount
|
(621
|
)
|
326
|
|
374
|
|
|||
Equity-based compensation
|
14,422
|
|
13,933
|
|
8,775
|
|
|||
Amortization of debt discount and issuance costs
|
6,849
|
|
—
|
|
—
|
|
|||
Realized gain on available-for-sale securities
|
—
|
|
—
|
|
(6
|
)
|
|||
Loss on disposal of property and equipment
|
678
|
|
240
|
|
23
|
|
|||
(Increase) decrease in assets:
|
|
|
|
|
|
|
|||
Accounts receivable
|
86
|
|
(1,912
|
)
|
43
|
|
|||
Inventory
|
(4,223
|
)
|
(7,759
|
)
|
—
|
|
|||
Prepaid expense and other assets
|
(250
|
)
|
(459
|
)
|
1,121
|
|
|||
Increase (decrease) in liabilities:
|
|
|
|
|
|
|
|||
Accounts payable
|
(748
|
)
|
1,064
|
|
(1,242
|
)
|
|||
Accrued liabilities
|
1,426
|
|
596
|
|
1,619
|
|
|||
Accrued interest
|
1,262
|
|
—
|
|
—
|
|
|||
Deferred revenue and income
|
(904
|
)
|
36
|
|
(92
|
)
|
|||
Deferred compensation
|
32
|
|
21
|
|
—
|
|
|||
Net cash used in operating activities
|
(67,756
|
)
|
(55,746
|
)
|
(53,408
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
||||||
Purchases of equipment
|
(998
|
)
|
(2,966
|
)
|
(2,409
|
)
|
|||
Purchase of marketable securities
|
(120,556
|
)
|
(82,333
|
)
|
(74,075
|
)
|
|||
Proceeds from sales of marketable securities
|
3,000
|
|
11,522
|
|
9,716
|
|
|||
Maturities of marketable securities
|
98,416
|
|
48,049
|
|
17,200
|
|
|||
Net cash used in investing activities
|
(20,138
|
)
|
(25,728
|
)
|
(49,568
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
||||||
Proceeds from exercise of warrants and options
|
3,749
|
|
6,606
|
|
1,497
|
|
|||
Common stock issuance cost
|
—
|
|
—
|
|
(814
|
)
|
|||
Proceeds from issuance of common stocks and warrants
|
583
|
|
83,821
|
|
226
|
|
|||
Recovery of related party short-swing profits
|
—
|
|
—
|
|
866
|
|
|||
Payments on capital lease obligations
|
—
|
|
—
|
|
(13
|
)
|
|||
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
|
125,771
|
|
90,427
|
|
1,762
|
|
|||
|
|
|
|
||||||
Effect of exchange rate on cash
|
(130
|
)
|
316
|
|
(127
|
)
|
|||
|
|
|
|
||||||
Increase (decrease) in cash and cash equivalents
|
37,747
|
|
9,269
|
|
(101,341
|
)
|
|||
Cash and cash equivalents, beginning of period
|
28,513
|
|
19,244
|
|
120,585
|
|
|||
Cash and cash equivalents, end of period
|
$
|
66,260
|
|
$
|
28,513
|
|
$
|
19,244
|
|
|
Years Ended December 31,
|
||||||||
|
2018
|
2017
|
2016
|
||||||
Non-cash investing activities:
|
|
|
|
||||||
Transfer of instruments from inventory to property and equipment
|
$
|
4,767
|
|
$
|
—
|
|
$
|
—
|
|
Supplemental cash flow information:
|
|
|
|
||||||
Interest paid
|
$
|
2,001
|
|
$
|
—
|
|
$
|
—
|
|
Income taxes paid
|
$
|
651
|
|
$
|
—
|
|
$
|
—
|
|
•
|
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).
|
|
2018
|
2017
|
2016
|
||||||
Beginning balance
|
$
|
192
|
|
$
|
1
|
|
$
|
—
|
|
Provisions
|
420
|
|
331
|
|
18
|
|
|||
Warranty expenses incurred
|
(397
|
)
|
(140
|
)
|
(17
|
)
|
|||
|
$
|
215
|
|
$
|
192
|
|
$
|
1
|
|
•
|
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
|
•
|
Volatility: The expected volatility is based on the historical volatility of the Company's stock price over the most recent period commensurate with the expected term of the stock option award.
|
•
|
Expected term: The estimated expected term for employee awards is based on the calculation published by the SEC in SAB110 for use when there is not a sufficient history of employee exercise patterns. For consultant awards, the estimated expected term is the same as the life of the award.
|
•
|
Risk-free interest rate: The risk-free interest rate is based on published U.S. Treasury rates for a term commensurate with the expected term.
|
•
|
Dividend yield: The dividend yield is estimated as
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.
|
|
2018
|
|||||||||||
|
(in thousands)
|
|||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
Significant
Other
Observable Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Total
|
||||||||
Assets:
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
||||||||
Money market funds
|
$
|
38,444
|
|
$
|
—
|
|
$
|
—
|
|
$
|
38,444
|
|
Commercial paper
|
—
|
|
1,493
|
|
—
|
|
1,493
|
|
||||
Total cash and cash equivalents
|
$
|
38,444
|
|
$
|
1,493
|
|
$
|
—
|
|
$
|
39,937
|
|
Investments:
|
|
|
|
|
||||||||
Certificates of deposit
|
—
|
|
10,787
|
|
—
|
|
10,787
|
|
||||
US Treasury securities
|
22,120
|
|
—
|
|
—
|
|
22,120
|
|
||||
US Agency securities
|
—
|
|
7,980
|
|
—
|
|
7,980
|
|
||||
Commercial paper
|
—
|
|
17,025
|
|
—
|
|
17,025
|
|
||||
Asset-backed securities
|
—
|
|
11,998
|
|
—
|
|
11,998
|
|
||||
Corporate notes and bonds
|
—
|
|
30,308
|
|
—
|
|
30,308
|
|
||||
Total investments
|
22,120
|
|
78,098
|
|
—
|
|
100,218
|
|
||||
Total assets measured at fair value
|
$
|
60,564
|
|
$
|
79,591
|
|
$
|
—
|
|
$
|
140,155
|
|
|
2017
|
|||||||||||
|
(in thousands)
|
|||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
Significant
Other
Observable Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Total
|
||||||||
Assets:
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
||||||||
Money market funds
|
$
|
7,832
|
|
$
|
—
|
|
$
|
—
|
|
$
|
7,832
|
|
Investments:
|
|
|
|
|
||||||||
Certificates of deposit
|
—
|
|
13,441
|
|
—
|
|
13,441
|
|
||||
US Treasury securities
|
14,716
|
|
—
|
|
—
|
|
14,716
|
|
||||
US 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
|
|
AVAILABLE-FOR-SALE INVESTMENTS
|
||||||||||||
2018
|
||||||||||||
(in thousands)
|
||||||||||||
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
||||||||
Certificates of deposit
|
$
|
10,787
|
|
$
|
—
|
|
$
|
—
|
|
$
|
10,787
|
|
US Treasury securities
|
22,185
|
|
1
|
|
(66
|
)
|
22,120
|
|
||||
US Agency securities
|
8,024
|
|
1
|
|
(45
|
)
|
7,980
|
|
||||
Commercial paper
|
17,025
|
|
—
|
|
—
|
|
17,025
|
|
||||
Asset-backed securities
|
12,007
|
|
—
|
|
(9
|
)
|
11,998
|
|
||||
Corporate notes and bonds
|
30,361
|
|
—
|
|
(53
|
)
|
30,308
|
|
||||
Total
|
$
|
100,389
|
|
$
|
2
|
|
$
|
(173
|
)
|
$
|
100,218
|
|
AVAILABLE-FOR-SALE INVESTMENTS
|
||||||||||||
2017
|
||||||||||||
(in thousands)
|
||||||||||||
|
Amortized Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair Value
|
||||||||
Certificates of deposit
|
$
|
13,441
|
|
$
|
—
|
|
$
|
—
|
|
$
|
13,441
|
|
US Treasury securities
|
14,787
|
|
—
|
|
(71
|
)
|
14,716
|
|
||||
US 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
|
|
AVAILABLE-FOR-SALE INVESTMENT MATURITIES
|
||||||||||||
(in thousands)
|
||||||||||||
|
2018
|
2017
|
||||||||||
|
Amortized
Cost
|
Fair Value
|
Amortized
Cost
|
Fair Value
|
||||||||
Due in less than 1 year
|
$
|
83,030
|
|
$
|
82,893
|
|
$
|
55,801
|
|
$
|
55,735
|
|
Due in 1-5 years
|
17,359
|
|
17,325
|
|
25,040
|
|
24,913
|
|
||||
Total
|
$
|
100,389
|
|
$
|
100,218
|
|
$
|
80,841
|
|
$
|
80,648
|
|
|
2018
|
2017
|
||||
Raw materials
|
$
|
4,064
|
|
$
|
4,220
|
|
Work in process
|
495
|
|
377
|
|
||
Finished goods
|
3,187
|
|
3,466
|
|
||
Inventory, net
|
$
|
7,746
|
|
$
|
8,063
|
|
PROPERTY AND EQUIPMENT
|
||||||
(in thousands)
|
||||||
|
2018
|
2017
|
||||
Computer equipment
|
$
|
2,700
|
|
$
|
2,756
|
|
Technical equipment
|
3,868
|
|
3,348
|
|
||
Facilities
|
4,037
|
|
3,621
|
|
||
Instruments
|
5,318
|
|
1,400
|
|
||
Capital projects in progress
|
91
|
|
349
|
|
||
Total property and equipment
|
$
|
16,014
|
|
$
|
11,474
|
|
Accumulated depreciation
|
(8,711
|
)
|
(6,584
|
)
|
||
Net property and equipment
|
$
|
7,303
|
|
$
|
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
.
|
|
2018
|
2017
|
||||
Products and services not yet delivered
|
$
|
217
|
|
$
|
71
|
|
Arizona Commerce Authority grant
|
—
|
|
1,000
|
|
||
Deferred revenue and income
|
$
|
217
|
|
$
|
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.
|
|
2018
|
2017
|
2016
|
|||
Shares issuable upon the release of warrants
|
—
|
|
—
|
|
416
|
|
Shares issuable upon the release of restricted stock awards
|
76
|
|
24
|
|
40
|
|
Shares issuable upon exercise of stock options
|
8,091
|
|
7,328
|
|
6,857
|
|
|
8,167
|
|
7,352
|
|
7,313
|
|
Stock Option Activity
|
|||||
|
Number of Shares
|
Weighted Average Exercise Price per Share
|
|||
Options Outstanding January 1, 2017
|
6,857,124
|
|
$
|
7.72
|
|
Granted
|
1,208,542
|
|
23.84
|
|
|
Forfeited
|
(79,962
|
)
|
17.82
|
|
|
Exercised
|
(656,846
|
)
|
8.93
|
|
|
Expired
|
(727
|
)
|
24.45
|
|
|
Options Outstanding December 31, 2017
|
7,328,131
|
|
10.16
|
|
|
Granted
|
1,390,014
|
|
24.46
|
|
|
Forfeited
|
(230,779
|
)
|
21.47
|
|
|
Exercised
|
(357,373
|
)
|
10.49
|
|
|
Expired
|
(39,357
|
)
|
22.24
|
|
|
Options Outstanding December 31, 2018
|
8,090,636
|
|
12.22
|
|
|
Exercisable December 31, 2018
|
5,824,748
|
|
8.39
|
|
RSU and SG Activity
|
|||||
|
Number of Shares
|
Weighted Average Grant Date Fair Value per Share
|
|||
RSUs & SGs Outstanding January 1, 2017
|
40,250
|
|
$
|
20.91
|
|
Granted
|
1,911
|
|
22.40
|
|
|
Forfeited
|
—
|
|
—
|
|
|
Vested/released
|
(18,011
|
)
|
21.07
|
|
|
RSUs & SGs outstanding December 31, 2017
|
24,150
|
|
20.91
|
|
|
Granted
|
76,000
|
|
17.33
|
|
|
Forfeited
|
—
|
|
—
|
|
|
Vested/released
|
(24,150
|
)
|
16.58
|
|
|
RSUs & SGs outstanding December 31, 2018
|
76,000
|
|
18.70
|
|
RSU and SG Grants
|
|||||||||
|
2018
|
2017
|
2016
|
||||||
Weighted average fair value
|
$
|
17.33
|
|
$
|
22.40
|
|
$
|
—
|
|
Equity-Based Compensation Expenses and Tax Benefit
(in thousands)
|
|||||||||
|
2018
|
2017
|
2016
|
||||||
Cost of Sales
|
$
|
189
|
|
$
|
99
|
|
$
|
—
|
|
Research and development
|
4,760
|
|
3,738
|
|
1,585
|
|
|||
Sales, general and administrative
|
9,473
|
|
10,096
|
|
7,190
|
|
|||
Total equity-based compensation expense
|
$
|
14,422
|
|
$
|
13,933
|
|
$
|
8,775
|
|
Recognized tax benefit
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
|
2018
|
2017
|
2016
|
||||||
U.S. Domestic
|
$
|
(67,508
|
)
|
$
|
(46,849
|
)
|
$
|
(48,539
|
)
|
Foreign
|
(20,607
|
)
|
(16,686
|
)
|
(17,568
|
)
|
|||
Net loss before income taxes
|
$
|
(88,115
|
)
|
$
|
(63,535
|
)
|
$
|
(66,107
|
)
|
|
2018
|
2017
|
2016
|
||||||
Current:
|
|
|
|
||||||
Federal
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
State
|
14
|
|
—
|
|
—
|
|
|||
Foreign
|
197
|
|
493
|
|
267
|
|
|||
Total current provision
|
211
|
|
493
|
|
267
|
|
|||
Deferred:
|
|
|
|
||||||
Federal
|
—
|
|
—
|
|
—
|
|
|||
State
|
—
|
|
—
|
|
—
|
|
|||
Foreign
|
—
|
|
—
|
|
—
|
|
|||
Total deferred provision
|
—
|
|
—
|
|
—
|
|
|||
Total provision
|
$
|
211
|
|
$
|
493
|
|
$
|
267
|
|
|
2018
|
2017
|
||||
Deferred tax assets:
|
|
|
||||
Net operating loss carryforward
|
$
|
53,189
|
|
$
|
41,086
|
|
Property & equipment
|
648
|
|
524
|
|
||
Inventory
|
395
|
|
58
|
|
||
Stock options
|
11,473
|
|
8,195
|
|
||
Intangible assets, definite-lived
|
40
|
|
42
|
|
||
General business credit
|
9,300
|
|
6,651
|
|
||
Deferred revenue
|
23
|
|
253
|
|
||
Other
|
24
|
|
45
|
|
||
Total deferred income tax assets
|
75,092
|
|
56,854
|
|
||
Valuation allowance
|
(63,060
|
)
|
(56,854
|
)
|
||
Deferred tax assets
|
$
|
12,032
|
|
$
|
—
|
|
|
|
|
||||
Deferred income tax liabilities:
|
|
|
||||
Debt amortization
|
$
|
(12,032
|
)
|
$
|
—
|
|
Total deferred income tax liabilities
|
$
|
(12,032
|
)
|
$
|
—
|
|
|
|
|
||||
Net deferred income taxes
|
$
|
—
|
|
$
|
—
|
|
|
2018
|
2017
|
2016
|
|||
U.S. federal statutory income tax rate
|
(21.00
|
)%
|
(34.00
|
)%
|
(34.00
|
)%
|
State taxes, net of federal tax benefit
|
(3.07
|
)
|
(2.62
|
)
|
(1.69
|
)
|
Permanent and other differences
|
(0.26
|
)
|
(2.31
|
)
|
(0.17
|
)
|
Change in tax rates
|
(0.41
|
)
|
(1.02
|
)
|
0.67
|
|
Tax rate differential
|
4.92
|
|
8.99
|
|
8.62
|
|
Tax cuts and jobs act
|
—
|
|
38.46
|
|
—
|
|
Unrecognized tax benefits
|
0.81
|
|
1.20
|
|
1.09
|
|
Nondeductible equity and other compensation
|
(0.17
|
)
|
(4.31
|
)
|
1.17
|
|
Credit for increased research activities
|
(3.12
|
)
|
(4.42
|
)
|
(3.31
|
)
|
Change in Valuation allowance
|
22.54
|
|
0.81
|
|
28.02
|
|
|
0.24
|
%
|
0.78
|
%
|
0.40
|
%
|
|
2018
|
2017
|
2016
|
||||||
Balance at beginning of year
|
$
|
2,141
|
|
$
|
1,101
|
|
$
|
343
|
|
Increases for prior positions
|
70
|
|
97
|
|
37
|
|
|||
Increases for current year positions
|
775
|
|
943
|
|
721
|
|
|||
Other increases
|
—
|
|
—
|
|
—
|
|
|||
Decreases due to settlements
|
—
|
|
—
|
|
—
|
|
|||
Expiration of the statute of limitations for the assessment of taxes
|
—
|
|
—
|
|
—
|
|
|||
Other decreases
|
(3
|
)
|
—
|
|
—
|
|
|||
Balance at end of year
|
$
|
2,983
|
|
$
|
2,141
|
|
$
|
1,101
|
|
2019
|
$
|
334
|
|
2020
|
154
|
|
|
2021
|
97
|
|
|
2022
|
22
|
|
|
Thereafter
|
—
|
|
|
Total
|
$
|
607
|
|
|
2018
|
2017
|
||||
Domestic
|
$
|
6,309
|
|
$
|
3,779
|
|
Foreign
|
994
|
|
1,111
|
|
||
|
$
|
7,303
|
|
$
|
4,890
|
|
|
2018
|
2017
|
2016
|
||||||
Domestic
|
$
|
4,153
|
|
$
|
3,016
|
|
$
|
238
|
|
Foreign
|
1,517
|
|
1,161
|
|
8
|
|
|||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
246
|
|
|
2018
|
2017
|
2016
|
||||||
Accelerate Pheno™ revenue
|
$
|
5,547
|
|
$
|
4,057
|
|
$
|
163
|
|
Other revenue
|
123
|
|
120
|
|
83
|
|
|||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
246
|
|
|
2018
|
2017
|
2016
|
||||||
Products
|
$
|
5,576
|
|
$
|
4,157
|
|
$
|
246
|
|
Services
|
94
|
|
20
|
|
—
|
|
|||
Net sales
|
$
|
5,670
|
|
$
|
4,177
|
|
$
|
246
|
|
|
December 31,
|
September 30,
|
June 30,
|
March 31,
|
||||||||
Revenue
|
$
|
1,822
|
|
$
|
1,355
|
|
$
|
1,692
|
|
$
|
801
|
|
Gross profit
|
$
|
524
|
|
$
|
675
|
|
$
|
975
|
|
$
|
309
|
|
Loss from operations
|
$
|
(19,759
|
)
|
$
|
(19,369
|
)
|
$
|
(20,415
|
)
|
$
|
(20,826
|
)
|
Net loss
|
$
|
(22,191
|
)
|
$
|
(22,098
|
)
|
$
|
(23,225
|
)
|
$
|
(20,812
|
)
|
Basic and diluted net loss per share
|
$
|
(0.41
|
)
|
$
|
(0.41
|
)
|
$
|
(0.43
|
)
|
$
|
(0.37
|
)
|
|
December 31,
|
September 30,
|
June 30,
|
March 31,
|
||||||||
Revenue
|
$
|
2,120
|
|
$
|
828
|
|
$
|
699
|
|
$
|
530
|
|
Gross profit
|
$
|
1,470
|
|
$
|
637
|
|
$
|
564
|
|
$
|
504
|
|
Loss from operations
|
$
|
(16,136
|
)
|
$
|
(17,315
|
)
|
$
|
(16,423
|
)
|
$
|
(14,310
|
)
|
Net loss
|
$
|
(16,296
|
)
|
$
|
(17,075
|
)
|
$
|
(16,457
|
)
|
$
|
(14,200
|
)
|
Basic and diluted net loss per share
|
$
|
(0.29
|
)
|
$
|
(0.31
|
)
|
$
|
(0.31
|
)
|
$
|
(0.27
|
)
|
|
Page
|
Exhibit No.
|
Description
|
|
Filing Information
|
|
Incorporated by reference to Appendix B of 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 to the Registrant’s Current Report on Form 8-K filed on November 16, 2017
|
||
|
Filed herewith
|
||
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 28, 2018
|
||
|
Incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on March 28, 2018
|
||
|
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on November 15, 2004
|
||
|
Incorporated by reference to Annex C of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on May 17, 2012
|
||
|
Incorporated by reference to Exhibit 4.4 filed with the Registrant’s Form S-8 Registration Statement (No. 333-182930) on July 30, 2012
|
||
|
Incorporated by reference to Exhibit 10.5 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
|
||
|
Incorporated by reference to Exhibit 10.9 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
|
||
|
Incorporated by reference to Exhibit 10.10 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
|
||
|
Incorporated by reference to Exhibit 10.11 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
|
|
Incorporated by reference to Exhibit 10.12 filed with the Registrant’s Annual Report on Form 10-K for the fiscal year ended July 31, 2012
|
||
|
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on April 10, 2017
|
||
|
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement on Schedule 14A filed on April 10, 2017
|
||
|
Incorporated by reference to Exhibit 10.9.6 filed with the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018
|
||
|
Incorporated by reference to Exhibit 99.3 to the Form S-8 Registration Statement (No. 333-187439) filed by the Registrant on March 22, 2013
|
||
|
Incorporated by reference to Exhibit 99.4 to the Form S-8 Registration Statement (No. 333-187439) filed by the Registrant on March 22, 2013
|
||
|
Incorporated by reference to Exhibit 10.9.7 filed with the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018
|
||
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on March 28, 2018
|
||
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 28, 2018
|
||
|
Incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on December 28, 2018
|
||
|
Filed herewith
|
||
|
Filed herewith
|
||
|
Filed herewith
|
||
|
Filed herewith
|
||
|
Filed herewith
|
||
|
Filed herewith
|
||
101
|
XBRL Instance Document
|
|
Filed herewith
|
101
|
XBRL Taxonomy Extension Schema Document
|
|
Filed herewith
|
101
|
XBRL Taxonomy Calculation Linkbase Document
|
|
Filed herewith
|
101
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
Filed herewith
|
101
|
XBRL Taxonomy Label Linkbase Document
|
|
Filed herewith
|
101
|
XBRL Taxonomy Presentation Linkbase Document
|
|
Filed herewith
|
|
ACCELERATE DIAGNOSTICS, INC.
|
|
|
|
|
February 28, 2019
|
|
By: /s/ Lawrence Mehren
|
|
|
Lawrence Mehren
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Lawrence Mehren
Lawrence Mehren
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Steve Reichling
Steve Reichling
|
|
Corporate Secretary, Chief Financial Officer and Chief Accounting Officer (Principal Financial and Accounting Officer)
|
|
February 28, 2019
|
|
|
|
|
|
/s/ John Patience
John Patience
|
|
Chairman of the Board of Directors
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Jack Schuler
Jack Schuler
|
|
Director
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Matthew W. Strobeck, Ph.D.
Matthew W. Strobeck, Ph.D.
|
|
Director
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Frank ten Brink
Frank ten Brink
|
|
Director
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Mark Miller
Mark Miller
|
|
Director
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Charles Watts, M.D.
Charles Watts
|
|
Director
|
|
February 28, 2019
|
|
|
|
|
|
/s/ Tom Brown
Tom Brown
|
|
Director
|
|
February 28, 2019
|
EXECUTIVE
|
|
ACCELERATE DIAGNOSTICS, INC.
|
|
|
|
|
|
|
/s/ Juan Manuel Martín Duaigües
|
|
/s/ Lawrence Mehren
|
Juan Manuel Martín Duaigües
|
|
ITS: President and Chief Executive Officer
|
|
|
|
DATE: December 4, 2018
|
|
DATE: December 4, 2018
|
Legal Entity
|
Jurisdiction/Domicile
|
Accelerate Diagnostics UK Limited
|
England
|
Accelerate Diagnostics S.L.
|
Spain
|
Accelerate Diagnostics GmbH
|
Germany
|
Accelerate Diagnostics SARL
|
France
|
Accelerate Diagnostics S.r.l
|
Italy
|
Accelerate Diagnostics B.V.
|
Netherlands
|
AX Diagnostics C.V.
|
Netherlands
|
Accelerate Diagnostics Holdings, LLC
|
United States
|
Accelerate Diagnostics RUS Limited Liability Company
|
Russia
|
1.
|
I have reviewed this Annual Report on Form 10-K 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, 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.
|
February 28, 2019
|
/s/ Lawrence Mehren
|
|
Lawrence Mehren
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K 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, 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.
|
February 28, 2019
|
/s/ Steve Reichling
|
|
Steve Reichling
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
February 28, 2019
|
/s/ Lawrence Mehren
|
|
Lawrence Mehren
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
February 28, 2019
|
/s/ Steve Reichling
|
|
Steve Reichling
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|