TUCSON,
Ariz., May 8, 2024 /PRNewswire/ -- Accelerate
Diagnostics, Inc. (Nasdaq: AXDX) today announced financial
preliminary results for the first quarter ended March 31, 2024.
"During the quarter we installed our first pre-clinical trial
site demonstrating our ability to successfully ship, install, train
and run the Accelerate Wave™ system with
Gram-Negative Positive Blood Culture samples in a clinical
microbiology lab," commented Jack Phillips, President and CEO
of Accelerate Diagnostics, Inc. "We continue to target
starting our clinical trial towards the end of the second quarter.
In parallel to the clinical trial work, we are developing our Gram
Positive PBC menu. We continue to present the Accelerate Wave
to our current base of loyal customers and secure long-term rapid
susceptibility testing contracts. The interest in Wave
remains very high due to its differentiated and highly valued
features," Mr. Phillips continued.
First Quarter 2024 Operating Highlights
- Notable Wave program achievements during the quarter included:
- Pre-clinical trial site installation of the Accelerate Wave
system for Gram-Negative Positive Blood Culture (PBC) samples.
- Began development of Gram Positive PBC menu.
- Executed contract extensions with several strategic customers
which secures approximately 70% of U.S. Pheno® customer
base to longer-term contracts ahead of the Wave commercial
launch.
- In the United States, added 12
new contracted Pheno instruments during the quarter, ending
the quarter with 348 clinically live revenue-generating instruments
and another 75 contracted instruments in the process of being
implemented.
First Quarter 2024 Preliminary Financial Highlights
- Net sales for the quarter were $2.9
million, compared to $2.8
million for the same quarter of the prior year. Revenues
from consumable products increased by 7% compared to the same
period in the prior year.
- Gross margin was approximately 25% for the quarter, compared to
approximately 36% for the same quarter of the prior year. The
decline in gross margin resulted from lower capital instrument
product sales mix.
- Selling, general, and administrative (SG&A) costs for the
quarter were $5.7 million, compared
to $10.1 million for the same quarter
of the prior year. The decline in SG&A costs is a result of
lower employee-related expenses. SG&A costs include non-cash
stock-based compensation of $0.9
million and ($0.1) million,
respectively, for the same periods.
- Research and development (R&D) costs for the quarter were
$5.2 million, compared to
$7.0 million for the same quarter of
the prior year. The decline in R&D costs is a result of lower
employee-related expenses as well as lower third-party development
costs for our next generation susceptibility instrument Accelerate
Wave. R&D costs include non-cash stock-based compensation of
$0.4 million and $0.6 million, respectively, for the same
periods.
- Net loss was $17.0 million for
the quarter, resulting in $0.88 net
loss per share.
- Cash used in the first quarter was approximately $9.0 million, net of financing. This includes
approximately $1 million in pre-paid
annual expenses.
The preliminary results set forth above are not finalized, are
based on management's initial review of Accelerate's results as of
and for the quarter ended March 31,
2024, and are subject to revisions based upon closing
procedures and the completion of external auditor review of
Accelerate's financial statements. Actual results may differ
materially from these preliminary results as a result of the
completion of such closing procedures, final adjustments and other
developments arising between now and the time that Accelerate's
financial results are finalized, including as a result of
Accelerate finalizing its analysis of the accounting for its
previously announced January 2024
equity financing. Accordingly, investors are cautioned not to
place undue reliance on these preliminary results.
Full financial results for the quarter ended March 31, 2024 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
Management will host a conference call on Wednesday, May 8, 2024, at 4:30 p.m. Eastern Time to review first quarter
2024 results.
To listen to the first quarter 2024 results call by phone,
+1.877.883.0383 and enter Elite Entry Number: 2853328.
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 1893704 until May 29,
2024.
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 for 30 days.
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
operating income (loss) amounts excluding stock-based compensation
expenses.
Our management and board of directors use expenses excluding the
cost of stock-based compensation and certain impairment
transactions 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 and certain impairment transactions
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 and certain impairment transactions 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 operating income (loss) reported in
accordance with GAAP. The following tables present a reconciliation
of SG&A expenses, R&D expenses and operating income (loss)
excluding stock-based compensation and certain impairment
transactions to comparable GAAP measures for the periods
indicated:
|
Three Months Ended
March 31,
(in thousands)
|
|
2024
|
2023
|
|
Sales, general and
administrative
|
$5,706
|
$10,105
|
|
Non-cash equity-based
compensation as a component of sales, general and
administrative
|
860
|
(140)
|
|
Sales, general and
administrative less non-cash equity-based compensation
|
$4,846
|
$10,245
|
|
Three Months Ended
March 31,
(in thousands)
|
|
2024
|
2023
|
|
Research and
development
|
$5,173
|
$6,968
|
|
Non-cash equity-based
compensation as a component of research and development
|
379
|
605
|
|
Research and
development less non-cash equity-based compensation
|
$4,794
|
$6,363
|
|
Three Months Ended
March 31,
(in thousands)
|
|
2024
|
2023
|
|
Loss from
operations
|
$10,156
|
$16,062
|
|
Non-cash equity-based
compensation as a component of loss from operations
|
1,297
|
555
|
|
Loss from operations
less non-cash equity-based compensation
|
$8,859
|
$15,507
|
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 PhenoTest® BC
kit combine several technologies aimed at reducing the time
clinicians must wait to determine the most optimal antibiotic
therapy for deadly infections. The FDA cleared system and kit fully
automate the sample preparation steps to report phenotypic
antibiotic susceptibility results in approximately 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 "ACCELERATE ARC" and "ACCELERATE WAVE"
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 and the
related conference call are forward-looking or may have
forward-looking implications within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and the company
intends that such forward-looking statements be subject to the safe
harbors created thereby. These forward-looking statements, which
can be identified by the use of words such as "may," "will,"
"expect," "believe," "anticipate," "estimate," or "continue," or
variations thereon or comparable terminology, include but are not
limited to, statements about: the company's anticipated results for
the quarter ended March 31, 2024, the
company's future development plans and growth strategy, including
plans and objectives relating to its future operations, products
and performance; projections as to when certain key business
milestones may be achieved, expectations regarding the potential or
benefits of the company's products and technologies, projections of
future demand for the company's products, including the Accelerate
Wave system; the company's continued investment in new product
development to both enhance its existing products and bring new
ones to market; the company's expectations relating to current
supply chain impacts and inflationary pressures; the company's
expectations regarding its commercial partnerships, such as with
Bruker Corporation, including anticipated benefits from such
collaboration; the company's intentions and plans relating to
regulatory approvals, and the company's liquidity and capital
requirements. Actual results or developments may differ materially
from those projected or implied in these forward-looking statements
due to significant risks and uncertainties, including, but not
limited to: volatility throughout the global economy and the
related impacts to the businesses of the company's suppliers and
customers, whether due to customer demand fluctuations, supply
chain constraints and inflationary pressures or otherwise;
difficulties in resolving the company's continuing financial
condition and ability to obtain additional capital to meet its
financial obligations; the company's ability to obtain any
regulatory approvals; and less than expected operating and
financial benefits resulting from cost cutting measures. Other
important factors that could cause the company's actual results to
differ materially from those in its forward-looking statements
include those discussed in the company's filings with the
Securities and Exchange Commission (the "SEC"), including in the
"Risk Factors" sections of the company's most recently filed
periodic reports on Form 10-K and Form 10-Q and subsequent filings
with the SEC. These forward-looking statements are also based on
certain additional assumptions, including, but not limited to, that
the company will retain key management personnel; the company will
be successful in the commercialization of its products; the company
will obtain sufficient capital to commercialize its products and
continue development of complementary products; the company will be
successful in obtaining marketing authorization for its products
from the FDA and other regulatory agencies and governing bodies;
the company will be able to protect its intellectual property; the
company's ability to respond effectively to technological change;
the company's ability to accurately anticipate market demand for
its products; and that there will be no material adverse change in
the company's operations or business and general market and
industry 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. Forward-looking statements speak only as of
the date they are made and should not be relied upon as
representing the company's plans and expectations as of any
subsequent date.
|
ACCELERATE
DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED
BALANCE
SHEETS
Unaudited
(in thousands, except
share data)
|
|
|
March
31,
|
December
31,
|
|
2024
|
2023
|
|
ASSETS
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$14,606
|
$12,138
|
|
Investments
|
1,145
|
1,081
|
|
Trade accounts
receivable
|
2,217
|
2,622
|
|
Inventory
|
3,249
|
3,310
|
|
Prepaid
expenses
|
1,068
|
380
|
|
Purchase obligation put
option asset
|
—
|
3,419
|
|
Other current
assets
|
1,848
|
1,516
|
|
Total current
assets
|
24,133
|
24,466
|
|
Property and equipment,
net
|
3,197
|
2,389
|
|
Finance lease assets,
net
|
1,225
|
1,518
|
|
Operating lease right
of use assets, net
|
957
|
1,177
|
|
Other non-current
assets
|
1,210
|
1,816
|
|
Total assets
|
$30,722
|
$31,366
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$5,108
|
$4,796
|
|
Accrued
liabilities
|
3,351
|
3,243
|
|
Accrued
interest
|
1,014
|
164
|
|
Deferred revenue and
income, current
|
1,272
|
1,545
|
|
Current portion of
convertible notes
|
726
|
726
|
|
Common warrant
liability
|
3,035
|
—
|
|
Finance lease,
current
|
685
|
583
|
|
Operating lease,
current
|
940
|
977
|
|
Total current
liabilities
|
16,131
|
12,034
|
|
Finance lease,
non-current
|
81
|
262
|
|
Operating lease,
non-current
|
328
|
570
|
|
Deferred income,
non-current
|
1,110
|
1,122
|
|
Other non-current
liabilities
|
1,197
|
1,164
|
|
Convertible notes,
non-current
|
37,655
|
36,102
|
|
Total
liabilities
|
$56,502
|
$51,254
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
deficit:
|
|
|
|
Preferred shares,
$0.001 par value;
|
|
|
|
5,000,000 preferred
shares authorized and no shares issued or outstanding as of
March
31, 2024 and December 31, 2023
|
—
|
—
|
|
Common stock, $0.001
par value;
|
|
|
|
450,000,000 common
shares authorized with 21,811,706 shares issued and outstanding
on March 31, 2024 and 14,569,500 shares issued and outstanding on
December 31,
2023
|
21
|
14
|
|
Contributed
capital
|
705,706
|
694,634
|
|
Treasury
stock
|
(45,067)
|
(45,067)
|
|
Accumulated
deficit
|
(685,822)
|
(668,857)
|
|
Accumulated other
comprehensive loss
|
(618)
|
(612)
|
|
Total stockholders'
deficit
|
(25,780)
|
(19,888)
|
|
Total liabilities and
stockholders' deficit
|
$30,722
|
$31,366
|
|
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,
|
|
2024
|
2023
|
|
Net
sales
|
$2,921
|
$2,812
|
|
|
|
|
Cost of
sales
|
2,198
|
1,801
|
|
Gross profit
|
723
|
1,011
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Research and
development
|
5,173
|
6,968
|
|
Sales, general and
administrative
|
5,706
|
10,105
|
|
Total costs and
expenses
|
10,879
|
17,073
|
|
|
|
|
Loss from
operations
|
(10,156)
|
(16,062)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest
expense
|
(2,450)
|
(418)
|
|
Interest expense
related party
|
—
|
(1,013)
|
|
Loss on fair value
instruments
|
(3,951)
|
—
|
|
Foreign currency
exchange gain
|
19
|
233
|
|
Interest
income
|
200
|
420
|
|
Other (expense) income,
net
|
(627)
|
45
|
|
Total other expense,
net
|
(6,809)
|
(733)
|
|
|
|
|
Net loss before income
taxes
|
(16,965)
|
(16,795)
|
|
Provision for income
taxes
|
—
|
—
|
|
Net loss
|
($16,965)
|
($16,795)
|
|
|
|
|
Basic and diluted net
loss per share
|
($0.88)
|
($1.71)
|
|
Weighted average shares
outstanding
|
19,216
|
9,830
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
Net loss
|
($16,965)
|
($16,795)
|
|
Net unrealized loss on
debt securities available-for-sale
|
—
|
24
|
|
Foreign currency
translation adjustment
|
(6)
|
(255)
|
|
Comprehensive
loss
|
($16,971)
|
($17,026)
|
|
ACCELERATE
DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED
STATEMENTS OF CASH
FLOWS
Unaudited
(in
thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2024
|
2023
|
|
Cash flows from
operating activities:
|
|
|
|
Net loss
|
(16,965)
|
(16,795)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
858
|
802
|
|
Provision for bad
debts
|
19
|
—
|
|
Equity-based
compensation
|
1,297
|
555
|
|
Amortization of debt
discount and issuance costs
|
1,596
|
182
|
|
Amortization of debt
discount related-party
|
—
|
572
|
|
Loss on disposal of
property and equipment
|
71
|
11
|
|
Unrealized gain on
equity investments
|
(53)
|
(50)
|
|
Units offering issuance
cost
|
680
|
—
|
|
Loss on fair value
adjustments
|
3,951
|
—
|
|
(Increase) decrease in
assets:
|
|
|
|
Contributions to
deferred compensation plan
|
(12)
|
—
|
|
Accounts
receivable
|
386
|
(11)
|
|
Inventory
|
(85)
|
(140)
|
|
Prepaid expense and
other
|
(447)
|
(239)
|
|
Increase (decrease) in
liabilities:
|
|
|
|
Accounts
payable
|
312
|
(977)
|
|
Accrued liabilities and
other
|
(658)
|
1,945
|
|
Accrued
interest
|
850
|
235
|
|
Accrued interest due to
related-party
|
—
|
441
|
|
Deferred revenue and
income
|
(285)
|
(79)
|
|
Deferred
compensation
|
33
|
181
|
|
Net cash used in
operating activities
|
(8,452)
|
(13,367)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Purchases of
equipment
|
(513)
|
(12)
|
|
Maturities of
marketable securities
|
—
|
8,221
|
|
Net cash (used in)
provided by investing activities
|
(513)
|
8,209
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
Proceeds from issuance
of Units to related party
|
2,050
|
—
|
|
Proceeds from issuance
of Units
|
10,232
|
—
|
|
Units offering issuance
cost
|
(764)
|
—
|
|
Payments on finance
leases
|
(79)
|
(77)
|
|
Net cash provided by
financing activities
|
11,439
|
(77)
|
|
|
|
|
Effect of exchange rate
on cash
|
(6)
|
(262)
|
|
|
|
|
(Decrease) increase in
cash and cash equivalents
|
2,468
|
(5,497)
|
|
Cash and cash
equivalents, beginning of period
|
12,138
|
34,905
|
|
Cash and cash
equivalents, end of period
|
$14,606
|
$29,408
|
|
ACCELERATE
DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED
STATEMENTS OF CASH
FLOWS (CONTINUED)
Unaudited
(in
thousands)
|
|
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2024
|
2023
|
|
Non-cash investing
activities:
|
|
|
|
Net transfer of
instruments from inventory to property and equipment
|
$127
|
$71
|
|
Non-cash financing
activities:
Net transfer of
instruments from inventory to property and equipment
|
$43
|
$0
|
|
Accrued units offering
issuance cost
|
$473
|
$0
|
|
Supplemental cash
flow information:
|
|
|
|
Interest
paid
|
$10
|
$0
|
See accompanying notes to condensed consolidated
financial statements.
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SOURCE Accelerate Diagnostics, Inc.