TUCSON,
Ariz., May 16, 2022 /PRNewswire/ -- Accelerate
Diagnostics, Inc. (Nasdaq: AXDX) today announced financial results
for the first quarter for the period ended March 31, 2022.
"First quarter financial results were consistent with our
expectations," commented Jack Phillips, Chief Executive
Officer of Accelerate Diagnostics, Inc. "We also launched new
products, progressed key R&D milestones, and improved our
balance sheet position during the quarter."
First Quarter 2022 Highlights
- Added 2 contracted instruments and brought 5 instruments live
in the U.S. in the quarter.
- Added numerous Arc evaluation contracts in the U.S.
- Ended the first quarter with 313 U.S. clinically live and
revenue-generating instruments, with another 76 U.S. contracted
instruments in the process of being implemented and not yet
revenue-generating.
- Net sales were $3.0 million,
compared to $2.5 million in the first
quarter of 2021, or a 20% increase. Growth driven by a 29% increase
in recurring revenues.
- Gross margin was 27% for the quarter, compared to 36% in the
first quarter of 2021. The decrease in gross margins resulted from
continued increases in the costs of inputs to production and other
factors.
- Selling, general, and administrative (SG&A) costs for the
quarter were $10.7 million, compared
to $14.0 million from the same
quarter of the prior year. SG&A costs for the quarter excluding
non-cash stock-based compensation were $8.2
million, compared to $8.0
million from the same quarter of the prior year. Cash used
in SG&A was relatively unchanged.
- Research and development (R&D) costs for the quarter were
$6.0 million, compared to
$6.9 million from the same quarter of
the prior year. R&D costs, excluding non-cash stock-based
compensation expense, for the quarter were $5.7 million, compared to $4.1 million from the quarter of the prior year.
Cash used in R&D increased due to Arc-related study spend and
investment in Pheno II.
- Net loss was $14.2 million in the
first quarter, resulting in $0.21 net
loss per share. Net loss excluding non-cash stock-based
compensation expense for the first quarter was $11.2 million.
- Net cash used in the quarter was $13.2
million, and the company ended the quarter with total cash,
investments, and cash equivalents of $50.4
million.
- Raised $4.0 million from an
insider financing round.
- Reduced debt by $14.0 million
during the quarter through an equity exchange with principal bond
holder.
- Launched Accelerate Arc system and associated consumable kit
for blood culture samples during the quarter.
Full financial results for the quarter ending March 31, 2022, will be filed on Form 10-Q
through the Securities and Exchange Commission's (SEC) website at
http://www.sec.gov.
Audio Webcast and Conference Call
To listen to the 2022 first quarter financial results, call by
phone, +1.877.883.0383 and enter Elite Entry Number: 0355137.
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 the replay code 5137603 until
June 6, 2022.
This conference call will also be webcast and can be accessed
from the company's website at ir.axdx.com. A replay of the audio
webcast will be available until August 15,
2022.
Use of Non-GAAP Financial Measures
This press release contains certain financial measures that are
not recognized measures under accounting principles generally
accepted in the United States of
America ("GAAP"), which include SG&A, R&D, and Net
income (loss) amounts excluding stock-based compensation
expenses.
Our management and board of directors use expenses excluding the
cost of stock-based compensation to understand and evaluate our
operating performance and trends, to prepare and approve our annual
budget and to develop short-term and long-term operating and
financing plans. Accordingly, we believe that expenses excluding
the cost of stock-based compensation provides useful information
for investors in understanding and evaluating our operating results
in the same manner as our management and our board of directors.
Expenses excluding the cost of stock-based compensation is a
non-GAAP financial measure and should be considered in addition to,
not as superior to, or as a substitute for, SG&A expenses,
R&D expenses, and net income (loss) reported in accordance with
GAAP. The following tables present a reconciliation of SG&A
expenses, R&D expenses and net income (loss) excluding
stock-based compensation to comparable GAAP measures for the
periods indicated:
|
Three Months Ended
March 31,
(in thousands)
|
|
2022
|
2021
|
Sales, general and
administrative
|
$10,673
|
$14,029
|
Non-cash equity-based
compensation as a component of sales, general and
administrative
|
2,442
|
5,992
|
Sales, general and
administrative less non-cash equity-based compensation
|
$8,231
|
$8,037
|
|
|
Three Months Ended
March 31,
(in thousands)
|
|
2022
|
2021
|
Research and
development
|
$6,024
|
$6,895
|
Non-cash equity-based
compensation as a component of research and development
|
362
|
2,746
|
Research and
development less non-cash equity-based compensation
|
$5,662
|
$4,149
|
|
|
Three Months Ended
March 31,
(in thousands)
|
|
2022
|
Net loss
|
$14,185
|
Non-cash equity-based
compensation as a component of net loss
|
2,979
|
Net loss less non-cash
equity-based compensation
|
$11,206
|
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. is an in vitro diagnostics
company dedicated to providing solutions for the global challenges
of antibiotic resistance and sepsis. The Accelerate
Pheno® system and Accelerate Arc™ system are designed to
reduce the time clinicians must wait to determine the most optimal
antibiotic therapy for bacteremic patients. These diagnostic
systems are designed to serve clinical laboratories with automated
solutions to expedite time to identification and antimicrobial
susceptibility test (AST) results directly from positive blood
culture samples. Multiple external studies have proven that
Accelerate solutions deliver results 1 to 2 days faster than
existing methods, enabling clinicians to optimize antibiotic
selection and dosage specific to the individual patient's
infection, days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and
"ACCELERATE PHENOTEST" and "ACCELERATE ARC" and diamond shaped
logos and marks are trademarks or registered trademarks of
Accelerate Diagnostics, Inc.
For more information about the company, its products and
technology, or recent publications, visit axdx.com.
Forward-Looking Statements
Certain of the statements made in this press release are
forward-looking or may have forward-looking implications. 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 14, 2022, and in any other
reports that the company files with the Securities and Exchange
Commission. 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 SHEETS (in
thousands, except share data)
|
|
|
March
31,
|
December
31,
|
|
2022
|
2021
|
|
Unaudited
|
|
ASSETS
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$13,654
|
$39,898
|
Investments
|
36,722
|
23,720
|
Trade accounts
receivable
|
2,114
|
2,320
|
Inventory
|
5,505
|
5,067
|
Prepaid
expenses
|
1,522
|
768
|
Other current
assets
|
1,594
|
1,558
|
Total current
assets
|
61,111
|
73,331
|
Property and equipment,
net
|
5,108
|
5,389
|
Right of use
assets
|
2,347
|
2,510
|
Other non-current
assets
|
1,791
|
1,817
|
Total assets
|
$70,357
|
$83,047
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
Current
liabilities:
|
|
|
Accounts
payable
|
$2,717
|
$1,983
|
Accrued
liabilities
|
4,086
|
2,853
|
Accrued
interest
|
156
|
909
|
Deferred
revenue
|
398
|
451
|
Current portion of
long-term debt
|
82
|
80
|
Current portion of
finance lease
|
76
|
—
|
Current operating lease
liability
|
699
|
669
|
Total current
liabilities
|
8,214
|
6,945
|
Finance lease,
non-current
|
164
|
—
|
Operating lease
liability, non-current
|
2,192
|
2,381
|
Other non-current
liabilities
|
805
|
808
|
Convertible
notes
|
115,758
|
107,984
|
Total
liabilities
|
$127,133
|
$118,118
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
Stockholders'
deficit:
|
|
|
Preferred shares,
$0.001 par value;
|
|
|
5,000,000 preferred
shares authorized and 3,954,546 outstanding as of March 31, 2022
and December 31, 2021
|
4
|
4
|
Common stock, $0.001
par value;
|
|
|
100,000,000 common
shares authorized with 68,711,633 shares issued and outstanding on
March 31, 2022 and 100,000,000 common shares authorized with
67,649,018 shares issued and outstanding on December 31,
2021
|
69
|
68
|
Contributed
capital
|
547,381
|
580,652
|
Treasury
stock
|
(45,067)
|
(45,067)
|
Accumulated
deficit
|
(558,931)
|
(570,668)
|
Accumulated other
comprehensive loss
|
(232)
|
(60)
|
Total stockholders'
deficit
|
(56,776)
|
(35,071)
|
Total liabilities and
stockholders' deficit
|
$70,357
|
$83,047
|
ACCELERATE
DIAGNOSTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS Unaudited (in
thousands, except per share data)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2022
|
2021
|
Net
sales
|
$2,958
|
$2,518
|
|
|
|
Cost of
sales
|
2,156
|
1,621
|
Gross profit
|
802
|
897
|
|
|
|
Costs and
expenses:
|
|
|
Research and
development
|
6,024
|
6,895
|
Sales, general and
administrative
|
10,673
|
14,029
|
Total costs and
expenses
|
16,697
|
20,924
|
|
|
|
Loss from
operations
|
(15,895)
|
(20,027)
|
|
|
|
Other income
(expense):
|
|
|
Interest
expense
|
(917)
|
(4,090)
|
Gain on extinguishment
of debt
|
2,646
|
—
|
Foreign currency
exchange loss
|
9
|
(159)
|
Interest
income
|
22
|
43
|
Other expense,
net
|
(50)
|
(6)
|
Total other income
(expense), net
|
1,710
|
(4,212)
|
|
|
|
Net loss before income
taxes
|
(14,185)
|
(24,239)
|
Provision for income
taxes
|
—
|
—
|
Net loss
|
$(14,185)
|
$(24,239)
|
|
|
|
Basic and diluted net
loss per share
|
$(0.21)
|
$(0.41)
|
Weighted average shares
outstanding
|
67,755
|
58,520
|
|
|
|
Other comprehensive
loss:
|
|
|
Net loss
|
$(14,185)
|
$(24,239)
|
Net unrealized loss on
debt securities available-for-sale
|
(93)
|
(19)
|
Foreign currency
translation adjustment
|
(79)
|
(81)
|
Comprehensive
loss
|
$(14,357)
|
$(24,339)
|
ACCELERATE
DIAGNOSTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS Unaudited (in thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2022
|
2021
|
Cash flows from
operating activities:
|
|
|
Net loss
|
$(14,185)
|
$(24,239)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
616
|
659
|
Amortization of
investment discount
|
54
|
49
|
Equity-based
compensation
|
2,979
|
8,839
|
Amortization of debt
discount and issuance costs
|
163
|
2,996
|
Loss on disposal of
property and equipment
|
152
|
—
|
Gain on extinguishment
of debt
|
(2,647)
|
—
|
(Increase) decrease in
assets:
|
|
|
Contributions to
deferred compensation plan
|
(5)
|
(112)
|
Accounts
receivable
|
206
|
(401)
|
Inventory
|
(653)
|
(683)
|
Prepaid expense and
other
|
(714)
|
(292)
|
Increase (decrease) in
liabilities:
|
|
|
Accounts
payable
|
1,154
|
575
|
Accrued
liabilities
|
1,081
|
183
|
Accrued
interest
|
(751)
|
(1,048)
|
Deferred revenue and
income
|
(53)
|
(19)
|
Deferred
compensation
|
(3)
|
118
|
Net cash used in
operating activities
|
(12,606)
|
(13,375)
|
|
|
|
Cash flows from
investing activities:
|
|
|
Purchases of
equipment
|
(447)
|
—
|
Purchase of marketable
securities
|
(24,144)
|
(7,307)
|
Maturities of
marketable securities
|
10,950
|
15,829
|
Net cash (used in)
provided by investing activities
|
(13,641)
|
8,522
|
|
|
|
Cash flows from
financing activities:
|
|
|
Proceeds from issuance
of common stock
|
—
|
10,666
|
Proceeds from exercise
of options
|
—
|
1,109
|
Proceeds from issuance
of common stocks under employee purchase plan
|
77
|
80
|
Net cash provided by
financing activities
|
77
|
11,855
|
|
|
|
Effect of exchange rate
on cash
|
(74)
|
(57)
|
|
|
|
(Decrease) increase in
cash and cash equivalents
|
(26,244)
|
6,945
|
Cash and cash
equivalents, beginning of period
|
39,898
|
35,781
|
Cash and cash
equivalents, end of period
|
$13,654
|
$42,726
|
ACCELERATE
DIAGNOSTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS (CONTINUED) Unaudited (in
thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2022
|
2021
|
Non-cash investing
activities:
|
|
|
Net transfer of
instruments from inventory to property and equipment
|
$220
|
$306
|
Supplemental cash
flow information:
|
|
|
Interest
paid
|
$1,506
|
$2,144
|
Extinguishment of
Convertible Senior Notes through issuance of common
stock
|
$1,258
|
$—
|
See accompanying notes to condensed consolidated financial
statements.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/accelerate-diagnostics-reports-first-quarter-2022-financial-results-301547440.html
SOURCE Accelerate Diagnostics, Inc.