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
- Clinical trial performance consistent with previously released pre-clinical data
- 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.
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