TUCSON, Ariz., Aug. 6, 2018 /PRNewswire/ -- Accelerate
Diagnostics, Inc. today announced financial results for the quarter
ending June 30, 2018. The
company posted revenue of $1.7
million, up 142% from the prior year quarter, and reported a
record number of new agreements signed in the quarter bringing the
global total to 430 instruments. Contracts for customer evaluations
total 312 instruments while commercial placements grew to 118
across the U.S., European, and Middle
East regions.
"We're excited to report a record number of new customer
agreements this quarter," said Lawrence
Mehren, President and CEO. "While not yet fully translated
into revenue, this sales momentum, strong customer advocacy, and
upcoming clinical outcome data are quite encouraging."
In addition, the company reported securing new agreements with
prominent group purchasing organizations during the quarter. The
agreements, covering approximately 1,400 hospitals, add additional
value to member hospitals and aim to streamline the adoption
process.
The company also announced progress on the development of its
severe bacterial pneumonia kit including alignment with the U.S.
Food and Drug Administration (FDA) on a shorter and less complex,
510(k) regulatory pathway, and clinical trial for the test. The
expected start of the U.S. clinical trial is on or before our Q3
conference call.
Mr. Mehren, together with Steve
Reichling, the company's Chief Financial Officer, will host
a conference call to review the financial results, commercial
progress, and development updates at 4:15
p.m. Eastern Time on August 6,
2018.
Second quarter 2018 results
- Global install base increased by 25% during the quarter
- Net sales of $1.7 million for the
second quarter and $2.5 million year
to date, compared to $699 thousand
and $1.2 million, for the same
respective periods in the prior year
- Gross margin realized was 58% for the quarter and 52% year to
date
- Selling, general, and administrative expenses for the quarter
were $15.3M and $29.7M year to date as compared to $11.5M and $22.0M
from the respective same periods in the prior year. These
year-over-year increases were driven by higher personnel and
customer evaluation related costs in the US and EU
- Research and development costs for the quarter were
$6.1M and $12.9M year to date as compared to $5.5M and $9.8M
from the respective same periods in the prior year. These
year-over-year increases are the result of additional investments
in the preparation for respiratory clinical trials and expanded
scientific affairs activity
- Net loss of $23.2 million in the
second quarter and $44.0 million year
to date, or $0.43 and $0.80 per share on weighted average basic shares
of 54.0 million and 54.8 million shares outstanding, respectively.
This net loss includes $3.4 million
in non-cash stock-based compensation expense in the second quarter
and $9.0 million year to date.
- Net cash used in the quarter was $17.1
million, ending the quarter with total cash, investments,
and cash-equivalents from all activities of $197.4 million
Full financial results for the quarter ending June 30, 2018 will be filed on Form 10-Q through
the Securities and Exchange Commission's (SEC) website at
http://www.sec.gov. The company anticipates filing on August 7, 2018. Investors are cautioned not to
place undue reliance on these preliminary and unaudited estimates
in the event of material changes.
Audio Webcast and Conference Call
Listen to an audio webcast of the call by visiting the events
section of the company's investor relations website at ir.axdx.com.
A replay of the audio webcast will be available until August 27, 2018.
To participate in the conference call, dial +1.877.883.0383 and
enter the conference ID: 6994802
International participants may dial +1.412.902.6506. Please dial
in 10-15 minutes prior to the start of the conference. A replay of
the call will be available by telephone at +1.877.344.7529 (U.S.)
or +1.412.317.0088 (international) using access code 10120739 until
August 27, 2018.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (Nasdaq:AXDX), is an in
vitro diagnostics company dedicated to providing solutions for
the global challenges of sepsis, antibiotic resistance and
healthcare-associated infections. Every 3-4 seconds someone dies
from sepsis. In the United States,
sepsis remains a leading cause of death, taking more lives than
HIV, breast cancer, and prostate cancer combined. Bacteria are the
most common cause of the serious infections that lead to sepsis,
and continue to develop resistance to antibiotics. These antibiotic
resistant bacteria further complicate the treatment approach for
physicians who already wait days for lab results to determine which
antibiotics are likely to be effective against the infection.
The Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit
combine several technologies aimed at reducing the time clinicians
must wait to determine the most optimal antibiotic therapy for
these infections. The FDA cleared system and kit fully automate the
sample preparation steps to report phenotypic antibiotic
susceptibility results within 7 hours direct from positive blood
cultures. Recent external studies indicate the solution offers
results 1-2 days faster than existing methods, enabling clinicians
to optimize antibiotic selection and dosage specific to the
individual patient days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and
"ACCELERATE PHENOTEST" and diamond shaped logos and marks are
trademarks or registered trademarks of Accelerate Diagnostics,
Inc.
For more information about the company, its products or
technology, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are
forward looking, such as those, among others, about our projections
as to when certain key business milestones may be achieved, the
potential of our products or technology, the growth of the market,
our estimates as to the size of our market opportunity and
potential pricing, our competitive position and estimates of time
reduction to results, and our future development plans and growth
strategy. Actual results or developments may differ materially from
those projected or implied in these forward-looking statements.
Information about the risks and uncertainties faced
by Accelerate Diagnostics is contained in the section
captioned "Risk Factors" in the company's most recent Annual Report
on Form 10-K, filed with the Securities and Exchange
Commission on March 1, 2018, and in any other reports
that we file with the Securities and Exchange
Commission from time to time. The company's forward-looking
statements could be affected by general industry and market
conditions. Except as required by federal securities laws, the
company undertakes no obligation to update or revise these
forward-looking statements to reflect new events, uncertainties or
other contingencies.
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
BALANCE
SHEET
|
(in
thousands)
|
|
|
June
30,
|
December
31,
|
|
2018
|
2017
|
|
Unaudited
|
|
ASSETS
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
|
66,810
|
|
$
|
28,513
|
|
Investments
|
130,594
|
|
80,648
|
|
Trade accounts
receivable
|
1,823
|
|
1,946
|
|
Inventory
|
11,317
|
|
8,063
|
|
Prepaid
expenses
|
1,421
|
|
850
|
|
Other current
assets
|
643
|
|
468
|
|
Total current
assets
|
212,608
|
|
120,488
|
|
Property and
equipment, net
|
5,443
|
|
4,890
|
|
Intellectual
property, net
|
124
|
|
134
|
|
Other non-current
assets
|
78
|
|
—
|
|
Total
assets
|
$
|
218,253
|
|
$
|
125,512
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
Accounts
payable
|
$
|
2,355
|
|
$
|
2,080
|
|
Accrued
liabilities
|
5,302
|
|
3,636
|
|
Deferred revenue and
income
|
185
|
|
1,071
|
|
Total current
liabilities
|
7,842
|
|
6,787
|
|
Other long term
liabilities
|
26
|
|
21
|
|
Convertible
notes
|
115,499
|
|
—
|
|
Total
liabilities
|
$
|
123,367
|
|
$
|
6,808
|
|
|
|
|
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 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, 2017
|
54
|
|
56
|
|
Contributed
capital
|
426,091
|
|
360,620
|
|
Treasury
Stock
|
(45,067)
|
|
—
|
|
Accumulated
deficit
|
(286,058)
|
|
(241,972)
|
|
Accumulated other
comprehensive loss
|
(134)
|
|
—
|
|
Total stockholders'
equity
|
94,886
|
|
118,704
|
|
Total liabilities and
stockholders' equity
|
$
|
218,253
|
|
$
|
125,512
|
|
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
|
Unaudited
|
(in thousands, except
per share data)
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30,
|
June
30,
|
|
June
30,
|
June
30,
|
|
2018
|
2017
|
|
2018
|
2017
|
Net
sales
|
$
|
1,692
|
|
$
|
699
|
|
|
$
|
2,493
|
|
$
|
1,230
|
|
|
|
|
|
|
|
Cost of
sales
|
717
|
|
135
|
|
|
1,210
|
|
161
|
|
Gross
profit
|
975
|
|
564
|
|
|
1,283
|
|
1,069
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development
|
6,060
|
|
5,527
|
|
|
12,842
|
|
9,815
|
|
Sales, general and
administrative
|
15,330
|
|
11,460
|
|
|
29,682
|
|
21,988
|
|
Total costs and
expenses
|
21,390
|
|
16,987
|
|
|
42,524
|
|
31,803
|
|
|
|
|
|
|
|
Loss from
operations
|
(20,415)
|
|
(16,423)
|
|
|
(41,241)
|
|
(30,734)
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
Interest
expense
|
(3,205)
|
|
—
|
|
|
(3,363)
|
|
—
|
|
Foreign currency
exchange (loss)
|
(253)
|
|
(7)
|
|
|
(198)
|
|
(33)
|
|
Interest
income
|
774
|
|
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
|
(23,124)
|
|
(16,282)
|
|
|
(43,752)
|
|
(30,482)
|
|
Provision for income
taxes
|
(101)
|
|
(175)
|
|
|
(285)
|
|
(175)
|
|
Net loss
|
$
|
(23,225)
|
|
$
|
(16,457)
|
|
|
$
|
(44,037)
|
|
$
|
(30,657)
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
(0.43)
|
|
$
|
(0.31)
|
|
|
$
|
(0.80)
|
|
$
|
(0.58)
|
|
Weighted average
shares outstanding
|
54,003
|
|
53,568
|
|
|
54,821
|
|
52,732
|
|
|
|
|
|
|
|
Other
comprehensive loss:
|
|
|
|
|
|
Net loss
|
$
|
(23,225)
|
|
$
|
(16,457)
|
|
|
$
|
(44,037)
|
|
$
|
(30,657)
|
|
Net unrealized (loss)
gain on available-for-sale investments
|
(2)
|
|
3
|
|
|
(55)
|
|
3
|
|
Foreign currency
translation adjustment
|
(191)
|
|
204
|
|
|
(79)
|
|
204
|
|
Comprehensive
loss
|
$
|
(23,418)
|
|
$
|
(16,250)
|
|
|
$
|
(44,171)
|
|
$
|
(30,450)
|
|
ACCELERATE
DIAGNOSTICS, INC.
|
CONDENSED
CONSOLIDATED
|
STATEMENTS OF CASH
FLOWS
|
Unaudited
|
(in
thousands)
|
|
|
Six Months
Ended
|
|
June
30,
|
June
30,
|
|
2018
|
2017
|
Cash flows from
operating activities:
|
|
|
Net loss
|
$
|
(44,037)
|
|
$
|
(30,657)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation
|
1,072
|
|
1,045
|
|
Amortization of
intangible assets
|
10
|
|
6
|
|
Amortization of
investment discount
|
(146)
|
|
219
|
|
Equity-based
compensation
|
9,011
|
|
7,450
|
|
Amortization of debt
discount and issuance costs
|
2,273
|
|
—
|
|
Loss on disposal of
property and equipment
|
266
|
|
5
|
|
(Increase) decrease
in assets:
|
|
|
Accounts
receivable
|
123
|
|
(648)
|
|
Inventory
|
(3,138)
|
|
(5,537)
|
|
Prepaid expense and
other
|
(444)
|
|
(624)
|
|
Other current
assets
|
(175)
|
|
(313)
|
|
Other non-current
assets
|
(78)
|
|
—
|
|
Increase (decrease)
in liabilities:
|
|
|
Accounts
payable
|
206
|
|
528
|
|
Accrued
liabilities
|
661
|
|
392
|
|
Accrued
Interest
|
1,105
|
|
—
|
|
Deferred revenue and
income
|
(935)
|
|
43
|
|
Deferred
compensation
|
5
|
|
—
|
|
Net cash used in
operating activities
|
(34,221)
|
|
(28,091)
|
|
Cash flows from
investing activities:
|
|
|
Purchases of
equipment
|
(1,898)
|
|
(1,643)
|
|
Purchases of
available-for-sale securities
|
(91,272)
|
|
(39,342)
|
|
Sales of
available-for-sale securities
|
3,000
|
|
6,522
|
|
Maturity of
available-for-sale securities
|
38,272
|
|
18,449
|
|
Net cash used in
investing activities
|
(51,898)
|
|
(16,014)
|
|
Cash flows from
financing activities:
|
|
|
Issuance of common
stock net of issuance costs
|
276
|
|
83,854
|
|
Exercise of options
and warrants
|
2,757
|
|
3,418
|
|
Proceeds from
issuance of convertible note
|
171,499
|
|
—
|
|
Prepayment of forward
stock repurchase transaction
|
(45,069)
|
|
—
|
|
Payment of debt
issuance costs
|
(4,991)
|
|
—
|
|
Net cash provided by
financing activities
|
124,472
|
|
87,272
|
|
|
|
|
Effect of exchange
rate on cash:
|
(56)
|
|
198
|
|
|
|
|
Increase in cash and
cash equivalents
|
38,297
|
|
43,365
|
|
Cash and cash
equivalents, beginning of period
|
28,513
|
|
19,244
|
|
Cash and cash
equivalents, end of period
|
$
|
66,810
|
|
$
|
62,609
|
|
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SOURCE Accelerate Diagnostics