TUCSON,
Ariz., Jan. 7, 2024 /PRNewswire/ --
Accelerate Diagnostics, Inc. (Nasdaq: AXDX) (Accelerate), an in
vitro diagnostics company dedicated to providing services that
improve patient outcomes and lower healthcare costs through the
rapid diagnosis of serious infections, today announced certain
preliminary, unaudited results for the quarter and year ended
December 31, 2023.
"In 2023, we made significant progress with the development of
our next-generation rapid Antimicrobial Susceptibility Testing
system, Accelerate WaveTM. We continue to advance this
important development program and remain on plan to begin our
clinical trials in the second quarter of 2024," commented Jack
Phillips, President and CEO of Accelerate
Diagnostics, Inc. "In addition, we continue to expand
and secure our Pheno® customer base, with an upgrade
path to Wave adoption. Based on consistent customer
feedback, Wave is anticipated to set the new standard for rapid,
same-shift, susceptibility testing," Mr. Phillips continued.
2023 Fourth Quarter Operational Results
- Notable Wave program achievements during the quarter
included:
-
- Completed Wave system integration.
- Significantly advanced AST performance of gram-negative
positive blood culture menu for approximately 250 bug-drug
combinations and running approximately 3,000 unique strains of
gram-negative organisms with average time-to-results below 4.5
hours.
- Completed extensive reviews with U.S. and EMEA customers to
validate Wave's product specifications and menu roll-out strategy.
Approximately 90% of customers have expressed interest in adopting
Accelerate Wave for both rapid positive blood culture and isolated
colony testing given unique perceived benefits compared to existing
and emerging automated susceptibility platforms.
- In the US, added six new contracted Pheno instruments
during the quarter, ending the quarter with 340 clinically live
Pheno revenue-generating instruments and another 71 contracted
Pheno instruments in the process of being implemented.
- Executed a collaboration and quality agreement with Bruker
Corporation for the Accelerate ArcTM system, made
significant progress towards completing the U.S. clinical trial and
anticipate submission to the FDA during the first quarter of
2024.
Preliminary 2023 Full Year Results
- Secured approximately 65% of current U.S. Pheno
customers to multi-year contracts for rapid susceptibility testing,
reflecting customers' commitment to Accelerate rapid AST technology
and interest in Wave.
- Preliminary revenue was approximately $12.1 million for the year, compared to
$12.8 million in the prior year.
While year-over-year revenues for consumable products increased by
approximately 5%, overall annual revenue was down year-over-year
due to a challenging capital sales environment in all our sales
regions.
- Ended the year with approximately $13.4
million in cash and cash equivalents, representing net cash
used in the fourth quarter of approximately $7.8 million. This reflects a continued reduction
in operating cash use over the prior quarters of 2023, following
cost cutting measures implemented throughout 2023.
The preliminary results set forth above are unaudited, are based
on management's initial review of Accelerate's results as of
and for the year ended December 31,
2023, and are subject to revisions based upon
Accelerate's year-end closing procedures and the completion of
the external audit of Accelerate's year-end financial
statements. Actual results may differ materially from these
preliminary unaudited results as a result of the completion of
year-end closing procedures, final adjustments and other
developments arising between now and the time that
Accelerate's financial results are finalized. In addition,
these preliminary unaudited results are not a comprehensive
statement of Accelerate's financial results for the year ended
December 31, 2023, should not be
viewed as a substitute for full, audited financial statements,
prepared in accordance with generally accepted accounting
principles, and are not necessarily indicative of the Company's
results for any future period. Accordingly, investors are cautioned
not to place undue reliance on these preliminary unaudited
results.
Accelerate expects to announce full-year 2023 financial results
in advance of its earnings conference call in March 2024.
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 are
forward-looking or may have forward-looking implications, such as,
among others: the company's anticipated results for the quarter and
year ended December 31, 2023; 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; expectations
regarding the company's customer base and demand for its products;
projections of future demand for the company's products; 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 clinical trials and regulatory
approvals, including the company's anticipated submission to the
FDA during the first quarter of 2024 for the Accelerate Arc system;
and the company's liquidity and capital requirements, including the
company's plan to continue to focus on cash burn reductions. 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; and the
company's ability to obtain any regulatory approvals. 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. 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.
Source: Accelerate Diagnostics Inc.
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SOURCE Accelerate Diagnostics, Inc.