TUCSON,
Ariz., Jan. 10, 2025 /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, 2024.
"During the fourth quarter, we continued our momentum across our
innovation pipeline with significant progress of the clinical trial
for our Accelerate WAVE™ system and the Gram-Negative assay
while also further driving progress in our commercial strategy and
making additional meaningful reductions in our cash burn,"
commented Jack Phillips, President and CEO of Accelerate
Diagnostics, Inc. "Specifically relating to our ongoing
clinical trial, we believe we are close to finalizing enrollment,
with very encouraging results to-date, and anticipate FDA
submission shortly after enrollment is complete. Throughout the
clinical trial, we have been able to demonstrate the distinct
features and benefits of the WAVE system compared to emerging rapid
antimicrobial susceptibility systems without any loss of
performance or features," Mr. Phillips continued.
2024 Fourth Quarter and Full-Year Operational Results
- Notable highlights of our ongoing WAVE System and Gram-Negative
(GN) Positive Blood Culture (PBC) Assay Clinical Trial:
-
- Clinical trial performance consistent with previously released
pre-clinical data
- Anticipate largest Gram-Negative bug-drug combination offering
for rapid PBC AST
- Time-to-result remains approximately 4.5 hours, on average
- Strong instrument, consumable and software reliability across
clinical trial sites
- Continued positive feedback from laboratory technicians on
simple pre-analytical workflow and seamless system ease of use
- Anticipate remaining on-track for FDA submission during the
first quarter of 2025 with anticipated commercial launch in late
2025
- Contracted a large U.S. reference lab for the Accelerate
Arc™ system, underscoring the utility of cost-effective,
rapid, and automated microbial identification on MALDI directly
from positive blood culture samples.
- In the U.S., we maintained approximately 350 of our existing
clinically live Pheno® revenue-generating instruments,
consistent with our commercial strategy.
- Continued to execute contract extensions with strategic
customers with greater than 75% of U.S. Pheno customers secured
through the anticipated WAVE commercial launch, subject to
regulatory approvals.
- Received 510(k) clearance of the Accelerate Arc system and BC
kit, an innovative, automated positive blood culture sample
preparation platform.
2024 Fourth Quarter and Full-Year Financial Results
- Preliminary revenue was approximately $11.7 million for the year, compared to
$12.1 million in the prior year.
While year-over-year revenues for consumable products increased by
approximately 3%, overall revenue was down year-over-year due to
lower revenues from capital sales of Pheno instruments compared to
the prior year.
- Ended the year with approximately $16.3
million in cash and cash equivalents, compared to
$20.9 million at the start of
the fourth quarter, a reduction in cash and cash equivalents for
the fourth quarter of 2024 of $4.5
million. This reflects our continued reduction in operating
cash use over the prior quarters of 2024.
The preliminary financial 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, 2024, 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, 2024, 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 2024 financial results
in advance of its earnings conference call in March 2025.
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. In addition to the Accelerate Arc
system, 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 Accelerate Pheno
system and Accelerate PhenoTest BC kit fully automate sample
preparation, identification and phenotypic antibiotic
susceptibility testing in approximately seven hours directly 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.
© Copyright 2024 Accelerate Diagnostics, Inc. All Rights
Reserved. The "ACCELERATE DIAGNOSTICS," "ACCELERATE PHENO,"
"ACCELERATE PHENOTEST," "ACCELERATE ARC" and "ACCELERATE WAVE"
diamond shaped logos and marks are trademarks or registered
trademarks of Accelerate Diagnostics, Inc. All other trademarks are
the property of their respective owners.
For more information about the company, its products and
technology, or recent publications, visit axdx.com.
Forward-Looking Statements
Certain 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 preliminary expected results for the quarter
and year ended December 31, 2024; the
company's product innovation progress and plans; the potential or
benefits of the company's existing and future products and
technologies, including the WAVE system, such as the expectation of
the performance of the WAVE system based on pre-clinical trials;
WAVE system clinical trial results and timing; FDA submission and
approval for the WAVE system, as well as commercialization launch
timelines and results; and the company's cash burn. 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.
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SOURCE Accelerate Diagnostics, Inc.
