Accelerate Diagnostics Announces Certain Preliminary Fourth Quarter and Full-Year 2024 Results
Accelerate Diagnostics (AXDX) has released preliminary, unaudited results for Q4 and full-year 2024. The company reported preliminary revenue of approximately $11.7 million for the year, compared to $12.1 million in 2023. While consumable product revenues increased by 3%, overall revenue declined due to lower Pheno instrument capital sales.
The company maintained around 350 revenue-generating Pheno instruments in the U.S. and secured over 75% of U.S. Pheno customers through the anticipated WAVE commercial launch. The ongoing WAVE System and Gram-Negative Clinical Trial shows promising results, with an average time-to-result of 4.5 hours. AXDX expects FDA submission in Q1 2025 with commercial launch anticipated in late 2025.
Cash and cash equivalents stood at $16.3 million at year-end, down from $20.9 million at the start of Q4, representing a $4.5 million reduction in the quarter, showing continued reduction in operating cash use.
Accelerate Diagnostics (AXDX) ha pubblicato i risultati preliminari e non verificati per il quarto trimestre e l'intero anno 2024. L'azienda ha riportato un fatturato preliminare di circa $11.7 milioni per l'anno, rispetto ai $12.1 milioni del 2023. Sebbene i ricavi dei prodotti di consumo siano aumentati del 3%, i ricavi complessivi sono diminuiti a causa delle vendite di strumenti Pheno.
L'azienda ha mantenuto circa 350 strumenti Pheno generatori di entrate negli Stati Uniti e ha assicurato oltre il 75% dei clienti Pheno statunitensi attraverso il previsto lancio commerciale del WAVE. Il sistema WAVE e la sperimentazione clinica Gram-Negativa mostrano risultati promettenti, con un tempo medio di risposta di 4.5 ore. AXDX prevede di presentare domanda alla FDA nel primo trimestre del 2025, con il lancio commerciale previsto per la fine del 2025.
La liquidità e gli equivalenti di liquidità ammontavano a $16.3 milioni alla fine dell'anno, in calo rispetto ai $20.9 milioni all'inizio del quarto trimestre, rappresentando una riduzione di $4.5 milioni nel trimestre, evidenziando una continua diminuzione nell'uso di liquidità operativa.
Accelerate Diagnostics (AXDX) ha publicado resultados preliminares y no auditados para el cuarto trimestre y el año completo 2024. La compañía reportó ingresos preliminares de aproximadamente $11.7 millones para el año, en comparación con $12.1 millones en 2023. Mientras los ingresos por productos consumibles aumentaron un 3%, los ingresos totales disminuyeron debido a la caída en las ventas de capital del instrumento Pheno.
La compañía mantuvo alrededor de 350 instrumentos Pheno generadores de ingresos en EE. UU. y aseguró más del 75% de los clientes de Pheno en EE. UU. a través del anticipado lanzamiento comercial de WAVE. El sistema WAVE y el ensayo clínico de Gram-Negativo muestran resultados prometedores, con un tiempo promedio de respuesta de 4.5 horas. AXDX espera presentar ante la FDA en el primer trimestre de 2025 con el lanzamiento comercial anticipado hacia finales de 2025.
El efectivo y equivalentes de efectivo se situaron en $16.3 millones a finales de año, una disminución desde los $20.9 millones al inicio del cuarto trimestre, representando una reducción de $4.5 millones en el trimestre, mostrando una continua reducción en el uso de efectivo operativo.
Accelerate Diagnostics (AXDX)는 2024년 4분기 및 전체 연도에 대한 예비 감사되지 않은 결과를 발표했습니다. 이 회사는 연간 $11.7 백만의 예비 수익을 보고했으며, 이는 2023년의 12.1 백만 달러와 비교됩니다. 소비 가능한 제품 수익은 3% 증가했지만, 전반적인 수익은 Pheno 기기 판매 감소로 인해 감소했습니다.
이 회사는 미국에서 약 350개의 수익 창출 Pheno 기기를 유지하고 있으며, 예상되는 WAVE 상업 출시를 통해 미국의 Pheno 고객의 75% 이상을 확보했습니다. 진행 중인 WAVE 시스템과 그람 음성 임상 시험은 평균 4.5시간의 결과 시간을 보여주는 고무적인 결과를 보여줍니다. AXDX는 2025년 1분기 내에 FDA 제출을 예상하며, 상업 출시를 2025년 말로 계획하고 있습니다.
현금 및 현금성 자산은 연말에 $16.3 백만으로, 4분기 시작 시 $20.9 백만에서 감소하여, 1분기 동안에 $4.5 백만의 감소를 나타내며 운영 현금 사용의 지속적인 감소를 보여줍니다.
Accelerate Diagnostics (AXDX) a publié des résultats préliminaires, non audités pour le quatrième trimestre et l'année entière 2024. L'entreprise a rapporté un chiffre d'affaires préliminaire d'environ $11.7 millions pour l'année, contre 12.1 millions de dollars en 2023. Alors que les revenus des produits consommables ont augmenté de 3 %, les revenus globaux ont diminué en raison d'une baisse des ventes d'instruments Pheno.
L'entreprise a maintenu environ 350 instruments Pheno générateurs de revenus aux États-Unis et a sécurisé plus de 75 % des clients Pheno américains grâce au lancement commercial anticipé de WAVE. Le système WAVE et l'essai clinique sur les bactéries Gram-négatif montrent des résultats prometteurs, avec un temps moyen de résultat de 4,5 heures. AXDX prévoit de soumettre une demande à la FDA au premier trimestre 2025, avec un lancement commercial prévu à la fin de 2025.
La trésorerie et les équivalents de trésorerie se sont élevés à $16.3 millions à la fin de l'année, en baisse par rapport à 20.9 millions de dollars au début du quatrième trimestre, représentant une réduction de 4.5 millions de dollars au cours du trimestre, montrant une réduction continue de l'utilisation de liquidités d'exploitation.
Accelerate Diagnostics (AXDX) hat vorläufige, nicht geprüfte Ergebnisse für das 4. Quartal und das gesamte Jahr 2024 veröffentlicht. Das Unternehmen berichtete von einem vorläufigen Umsatz von etwa $11.7 Millionen für das Jahr, im Vergleich zu 12.1 Millionen Dollar im Jahr 2023. Während die Umsätze mit Verbrauchsprodukten um 3% gestiegen sind, ist der Gesamtumsatz aufgrund geringerer Kapitalverkäufe von Pheno-Geräten gesunken.
Das Unternehmen hat rund 350 umsatzgenerierende Pheno-Geräte in den USA behalten und über 75% der US-Pheno-Kunden durch den erwarteten kommerziellen Start des WAVE gesichert. Das laufende WAVE-System und die klinische Studie zu gramnegativen Bakterien zeigen vielversprechende Ergebnisse, mit einer durchschnittlichen Zeit bis zum Ergebnis von 4,5 Stunden. AXDX erwartet die Einreichung bei der FDA im 1. Quartal 2025, mit einem erwarteten kommerziellen Start Ende 2025.
Bargeld und Bargeldäquivalente beliefen sich zum Jahresende auf $16.3 Millionen, ein Rückgang von $20.9 Millionen zu Beginn des 4. Quartals, was einen Rückgang von $4.5 Millionen im Quartal darstellt und die fortlaufende Reduzierung des Betriebsmittelverbrauchs zeigt.
- 3% year-over-year increase in consumable product revenues
- Secured over 75% of U.S. Pheno customers through anticipated WAVE launch
- Received 510(k) clearance for Accelerate Arc system and BC kit
- Contracted large U.S. reference lab for Accelerate Arc system
- Reduced operating cash burn compared to previous quarters
- Revenue declined to $11.7M from $12.1M year-over-year
- Lower capital sales of Pheno instruments compared to prior year
- Cash position decreased by $4.5M in Q4 2024
Insights
The preliminary financial results reveal concerning trends for AXDX. Revenue declined to
The maintenance of ~350 revenue-generating Pheno instruments indicates market stabilization but lacks growth. The
The micro-cap valuation of
The WAVE system's clinical trial progress shows promising technical achievements but faces critical timing challenges. The 4.5-hour average time-to-result for antimicrobial susceptibility testing (AST) represents a significant advancement over traditional methods that typically take 48-72 hours. The expansion into Gram-Negative testing with the largest bug-drug combination offering could provide a competitive edge in the rapid diagnostics market.
The 510(k) clearance for the Arc system demonstrates regulatory pathway viability, but the projected late 2025 commercial launch for WAVE creates a significant gap period. The reference lab contract for Arc validates the platform's utility but may not generate sufficient revenue to offset the development costs of WAVE. The preliminary clinical trial data alignment with pre-clinical results suggests robust methodology, though final validation remains pending.
The company's dual-platform strategy with Pheno and Arc, while awaiting WAVE, indicates a transitional phase that carries both operational and market risks. The success of WAVE will be important for long-term viability in the competitive rapid diagnostics space.
"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% ofU.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 $12.1 million 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 $20 $4.5 million
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.
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