Accelerate Diagnostics Reports Q2 2017 Financial Results, Doubles Revenue Generating Placements
August 03 2017 - 4:00PM
Accelerate Diagnostics, Inc. today announced preliminary financial
results for the quarter ending June 30, 2017. The company
further reported signed agreements for 265 instruments year to
date; contracts for customer evaluations have grown to 220
instruments while revenue generating placements have doubled to 45
across the U.S., European, and Middle East regions.
Net sales for the second quarter 2017 was $699,000 compared to
$20,000 in the second quarter of 2016. The increase was driven by
sales of the Accelerate Pheno™ system and Accelerate PhenoTest™ BC
kit.
“This past quarter was quite exciting,” said Lawrence Mehren,
President and CEO. “Despite complicated budgets and verification
requirements, enthusiasm for our solution remains high and
customers, supported by a number of recent studies confirming the
speed and accuracy of the system, continue to find ways to move to
acquisition.”
The company also reported completion of a multi-center pilot
study for its lower respiratory kit, currently under development.
The study provided early customer feedback and data for algorithm
development using a protocol that aims to reduce diagnostic
uncertainty for healthcare-acquired and ventilator-associated
pneumonia by 1-3 days.
President and Chief Executive Officer, Lawrence Mehren, and
Chief Financial Officer, Steve Reichling, will host a conference
call to review the results at 4:15 p.m. Eastern Time on August 3,
2017.
Preliminary second quarter 2017 results
- Net sales of $699,000 compared to $20,000 in the second quarter
of 2016
- Gross margin realized was 81% including inventory previously
recorded as research and development (R&D) expense
- Selling, general, and administrative expenses of $11.5 million,
compared to $9.5 million in the prior year period, driven by
customer evaluation and personnel related costs
- R&D expenses for the second quarter of $5.5 million,
compared to $8.4 million in the second quarter of 2016 due to
clinical trial and pre-launch inventory costs incurred in the prior
year period
- Net loss of $16.5 million, or $0.31 per share on weighted
average basic shares of 53.6 million shares outstanding, which
includes $4.2 million in non-cash stock-based compensation
expense
- Net cash for operations, separate from the sale of stock, was
$11.9 million, ending the quarter with total cash,
cash-equivalents, and short-term investments from all activities of
$135.2 million
Full financial results for the quarter ending June 30, 2017 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 7th. Investors are cautioned not to
place undue reliance on these preliminary estimates in the event of
material changes.
Conference Call
The conference call will begin at 4:15 p.m. Eastern Time (1:15
p.m. Pacific Time) on August 3, 2017. The live teleconference of
the call can be accessed through the company’s website at
http://ir.axdx.com.
To participate in the conference call, dial +1.877.883.0383 and
enter the conference ID: 8021823. 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 10108001 until August 17,
2017.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. (“Accelerate”) (Nasdaq:AXDX), is an
in vitro diagnostics company dedicated to providing solutions for
the global challenge of antibiotic resistance and
healthcare-associated infections. The company's Accelerate Pheno™
system and Accelerate PhenoTest™ BC kit were recently cleared by
the FDA for antimicrobial susceptibility testing direct from
positive blood culture samples. The solution leverages proprietary
molecular identification methods and morphokinetic cellular
analysis (MCA) to provide minimum inhibitory concentrations for a
range of applicable antibiotics. The fully-automated system
is designed to eliminate the lengthy culture and sample preparation
steps required prior to antimicrobial susceptibility testing.
Recent market studies suggest the solution offers results 1-2 days
faster than conventional methods, enabling clinicians to optimize
antibiotic selection, dosage, and infusion strategy specific to the
individual patient and their infection.
The “ACCELERATE DIAGNOSTICS” and “ACCELERATE PHENO” and
“ACCELERATE PHENOTEST” 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
market need, acceptant and integration of our products. 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 February 28, 2017, 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 |
Unaudited |
(in thousands) |
|
|
June 30, |
|
|
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
ASSETS |
Current assets: |
|
|
Cash and
cash equivalents |
$ |
62,609 |
|
|
|
$ |
19,244 |
|
|
Investments |
72,609 |
|
|
58,519 |
|
|
Trade
accounts receivable |
682 |
|
|
34 |
|
|
Inventory |
5,720 |
|
|
— |
|
|
Prepaid
expenses |
1,157 |
|
|
468 |
|
|
Other
current assets |
496 |
|
|
183 |
|
|
Total current
assets |
143,273 |
|
|
78,448 |
|
|
Property and equipment,
net |
4,844 |
|
|
4,258 |
|
|
Intellectual property,
net |
140 |
|
|
146 |
|
|
Total assets |
$ |
148,257 |
|
|
|
$ |
82,852 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
Current liabilities: |
|
|
Accounts
payable |
$ |
1,534 |
|
|
|
$ |
992 |
|
|
Accrued
liabilities |
3,611 |
|
|
3,009 |
|
|
Deferred
revenue and income |
1,078 |
|
|
35 |
|
|
Total
current liabilities |
6,223 |
|
|
4,036 |
|
|
Long-term deferred income |
— |
|
|
1,000 |
|
|
Total
liabilities |
$ |
6,223 |
|
|
|
$ |
5,036 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
Common stock, $0.001
par value; |
|
|
75,000,000 common shares authorized with 55,291,222 shares issued
and outstanding on June 30, 2017 and 75,000,000 authorized with
51,516,309 shares issued and outstanding on December 31, 2016
|
55 |
|
|
52 |
|
|
Preferred shares,
$0.001 par value; |
|
|
5,000,000
preferred shares authorized and none outstanding as of June 30,
2017 and December 31, 2016 |
— |
|
|
— |
|
|
Contributed capital |
350,577 |
|
|
255,257 |
|
|
Accumulated deficit |
(208,601 |
) |
|
(177,289 |
) |
|
Accumulated other comprehensive (loss) |
3 |
|
|
(204 |
) |
|
Total
stockholders’ equity |
142,034 |
|
|
77,816 |
|
|
Total
liabilities and stockholders’ equity |
$ |
148,257 |
|
|
|
$ |
82,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Net
sales |
$ |
699 |
|
|
|
$ |
20 |
|
|
|
$ |
1,230 |
|
|
|
$ |
183 |
|
|
|
|
|
|
|
Cost of
sales |
135 |
|
|
— |
|
|
|
161 |
|
|
— |
|
Gross Profit |
564 |
|
|
20 |
|
|
|
1,069 |
|
|
183 |
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
Research
and development |
5,527 |
|
|
8,425 |
|
|
|
9,815 |
|
|
16,100 |
|
Sales,
general and administrative |
11,460 |
|
|
9,484 |
|
|
|
21,988 |
|
|
17,144 |
|
Total
costs and expenses |
16,987 |
|
|
17,909 |
|
|
|
31,803 |
|
|
33,244 |
|
|
|
|
|
|
|
Loss from
operations |
(16,423 |
) |
|
(17,889 |
) |
|
|
(30,734 |
) |
|
(33,061 |
) |
|
|
|
|
|
|
Interest expense and
other |
(5 |
) |
|
— |
|
|
|
(5 |
) |
|
— |
|
Foreign currency
exchange loss |
(7 |
) |
|
(117 |
) |
|
|
(33 |
) |
|
(73 |
) |
Interest and dividend
income |
153 |
|
|
140 |
|
|
|
290 |
|
|
194 |
|
Total other income |
141 |
|
|
23 |
|
|
|
252 |
|
|
121 |
|
|
|
|
|
|
|
Net loss before income
taxes |
(16,282 |
) |
|
(17,866 |
) |
|
|
(30,482 |
) |
|
(32,940 |
) |
Provision from income
taxes |
(175 |
) |
|
— |
|
|
|
(175 |
) |
|
— |
|
Net loss |
$ |
(16,457 |
) |
|
|
$ |
(17,866 |
) |
|
|
$ |
(30,657 |
) |
|
|
$ |
(32,940 |
) |
|
|
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.31 |
) |
|
|
$ |
(0.35 |
) |
|
|
$ |
(0.58 |
) |
|
|
$ |
(0.64 |
) |
Weighted average shares
outstanding |
53,568 |
|
|
51,213 |
|
|
|
52,732 |
|
|
51,205 |
|
|
|
|
|
|
|
Other
comprehensive loss: |
|
|
|
|
|
Net
loss |
$ |
(16,457 |
) |
|
|
$ |
(17,866 |
) |
|
|
$ |
(30,657 |
) |
|
|
$ |
(32,940 |
) |
Net
unrealized gain on available-for-sale investments |
3 |
|
|
29 |
|
|
|
3 |
|
|
81 |
|
Foreign
currency translation adjustment |
204 |
|
|
49 |
|
|
|
204 |
|
|
— |
|
Comprehensive loss |
$ |
(16,250 |
) |
|
|
$ |
(17,788 |
) |
|
|
$ |
(30,450 |
) |
|
|
$ |
(32,859 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ACCELERATE DIAGNOSTICS, INC. |
CONDENSED CONSOLIDATED |
STATEMENT OF CASH FLOWS |
Unaudited |
(in thousands) |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
Cash flows from
operating activities: |
|
|
Net
loss |
$ |
(30,657 |
) |
|
$ |
(32,940 |
) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
Depreciation |
1,045 |
|
|
1,147 |
|
|
Amortization of intangible assets |
6 |
|
|
5 |
|
|
Amortization of investment discount |
219 |
|
|
123 |
|
|
Equity-based compensation |
7,450 |
|
|
3,921 |
|
|
Loss on
disposal of property & equipment |
5 |
|
|
— |
|
|
(Increase) decrease in assets: |
|
|
Accounts
receivable |
(648 |
) |
|
(92 |
) |
|
Inventory |
(5,537 |
) |
|
— |
|
|
Prepaid
expense and other |
(624 |
) |
|
272 |
|
|
Other
current assets |
(313 |
) |
|
(1,220 |
) |
|
Increase
(decrease) in liabilities: |
|
|
Accounts
payable |
528 |
|
|
(394 |
) |
|
Accrued
liabilities |
392 |
|
|
1,175 |
|
|
Deferred
revenue and income |
43 |
|
|
(84 |
) |
|
Net cash used in operating activities |
(28,091 |
) |
|
(28,087 |
) |
|
Cash flows from
investing activities: |
|
|
Purchases
of equipment |
(1,643 |
) |
|
(2,084 |
) |
|
Purchases
of available-for-sale securities |
(39,342 |
) |
|
(63,534 |
) |
|
Sales of
available-for-sale securities |
6,522 |
|
|
1,000 |
|
|
Maturity
of available-for-sale securities |
18,449 |
|
|
9,380 |
|
|
Net cash
used in investing activities |
(16,014 |
) |
|
(55,238 |
) |
|
Cash flows from
financing activities: |
|
|
Issuance
of common stock net issuance costs |
83,854 |
|
|
— |
|
|
Exercise
of options and warrants |
3,418 |
|
|
95 |
|
|
Common
stock issuance costs |
— |
|
|
(814 |
) |
|
Payments
on capital lease obligations |
— |
|
|
(13 |
) |
|
Recovery
of related party short-swing profits |
— |
|
|
991 |
|
|
Net cash
provided by financing activities |
87,272 |
|
|
259 |
|
|
|
|
|
Effect of
exchange rate on cash: |
198 |
|
|
— |
|
|
|
|
|
Increase (decrease) in
cash and cash equivalents |
43,365 |
|
|
(83,066 |
) |
|
Cash and cash
equivalents, beginning of period |
19,244 |
|
|
120,585 |
|
|
Cash and cash
equivalents, end of period |
$ |
62,609 |
|
|
$ |
37,519 |
|
|
Investors May Contact:
Laura Pierson, Accelerate Diagnostics, +1 520 365-3100, investors@axdx.com
Reporters May Contact:
Andrew Chasteen, Accelerate Diagnostics, +1 520 365-3100, achasteen@axdx.com
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