T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2024 Financial Results
T2 Biosystems (NASDAQ: TTOO) reported preliminary Q4 and full-year 2024 results, highlighting record product revenues of $2.3M for Q4 (37% increase) and $8.3M for 2024 (23% increase). The company secured 27 T2Dx® Instrument contracts in 2024, with 23 international and 4 U.S. installations.
Key developments include an exclusive U.S. distribution agreement with Cardinal Health, expanded international presence in six new markets, and debt reduction through converting $30M of CRG term loan into common stock, reducing quarterly interest payments by 80%. Cash position stood at $1.7M as of December 31, 2024.
The company received FDA 510(k) clearances for expanded T2Bacteria® Panel capabilities and pediatric testing for T2Candida® Panel. T2 Biosystems plans to submit the T2Resistance Panel for FDA 510(k) clearance in Q1 2025.
T2 Biosystems (NASDAQ: TTOO) ha riportato risultati preliminari per il quarto trimestre e per l'intero anno 2024, evidenziando ricavi record da prodotto pari a 2,3 milioni di dollari per il Q4 (aumento del 37%) e 8,3 milioni di dollari per il 2024 (aumento del 23%). L'azienda ha assicurato 27 contratti per strumenti T2Dx® nel 2024, con 23 installazioni internazionali e 4 negli Stati Uniti.
Sviluppi chiave includono un accordo di distribuzione esclusivo negli Stati Uniti con Cardinal Health, una presenza internazionale ampliata in sei nuovi mercati e riduzione del debito attraverso la conversione di 30 milioni di dollari di prestiti a termine CRG in azioni ordinarie, riducendo i pagamenti di interessi trimestrali dell'80%. La posizione di liquidità è stata di 1,7 milioni di dollari al 31 dicembre 2024.
L'azienda ha ricevuto autorizzazioni FDA 510(k) per le capacità espanse del pannello T2Bacteria® e per i test pediatrici del pannello T2Candida®. T2 Biosystems prevede di presentare il pannello T2Resistance per l'autorizzazione FDA 510(k) nel primo trimestre del 2025.
T2 Biosystems (NASDAQ: TTOO) reportó resultados preliminares para el cuarto trimestre y para todo el año 2024, destacando ingresos récord por productos de 2.3 millones de dólares para el Q4 (incremento del 37%) y 8.3 millones de dólares para 2024 (incremento del 23%). La compañía aseguró 27 contratos para instrumentos T2Dx® en 2024, con 23 instalaciones internacionales y 4 en los Estados Unidos.
Los desarrollos clave incluyen un acuerdo de distribución exclusivo en EE.UU. con Cardinal Health, una presencia internacional ampliada en seis nuevos mercados y reducción de deuda a través de la conversión de 30 millones de dólares de un préstamo a término de CRG en acciones comunes, reduciendo los pagos de intereses trimestrales en un 80%. La posición de efectivo se situó en 1.7 millones de dólares al 31 de diciembre de 2024.
La compañía recibió autorizaciones FDA 510(k) para capacidades ampliadas del panel T2Bacteria® y pruebas pediátricas para el panel T2Candida®. T2 Biosystems planea presentar el panel T2Resistance para la autorización FDA 510(k) en el primer trimestre de 2025.
T2 바이오시스템즈 (NASDAQ: TTOO)는 2024년 4분기 및 연간 예비 실적을 보고하며, 기록적인 제품 수익이 4분기에 230만 달러(37% 증가), 2024년에는 830만 달러(23% 증가)로 나타났습니다. 이 회사는 2024년에 27개의 T2Dx® 기계 계약을 확보했으며, 이 중 23개는 해외와 4개는 미국 내 설치입니다.
주요 개발 사항으로는 Cardinal Health와의 독점 미국 유통 계약, 여섯 개 신규 시장에서의 국제적 입지 확장, 3천만 달러의 CRG 장기 대출을 일반 주식으로 전환하며 부채를 줄여 분기별 이자 지급을 80% 감소시킨 점이 있습니다. 현금 보유량은 2024년 12월 31일 기준으로 170만 달러에 달합니다.
회사는 T2Bacteria® 패널의 능력을 확장하기 위한 FDA 510(k) 승인을 받았으며, T2Candida® 패널의 소아 검사에 대한 승인을 받았습니다. T2 바이오시스템즈는 2025년 1분기에 T2Resistance 패널에 대한 FDA 510(k) 승인을 제출할 계획입니다.
T2 Biosystems (NASDAQ: TTOO) a annoncé des résultats préliminaires pour le quatrième trimestre et pour l'année 2024, mettant en évidence des revenus record de produits de 2,3 millions de dollars pour le Q4 (augmentation de 37%) et de 8,3 millions de dollars pour 2024 (augmentation de 23%). L'entreprise a sécurisé 27 contrats pour des instruments T2Dx® en 2024, avec 23 installations internationales et 4 aux États-Unis.
Les développements clés incluent un accord de distribution exclusif aux États-Unis avec Cardinal Health, une présence internationale élargie dans six nouveaux marchés, et une réduction de la dette grâce à la conversion de 30 millions de dollars de prêts à terme CRG en actions ordinaires, réduisant ainsi les paiements d'intérêts trimestriels de 80%. La position de liquidité s'élevait à 1,7 million de dollars au 31 décembre 2024.
L'entreprise a reçu des autorisations FDA 510(k) pour des capacités élargies du panneau T2Bacteria® et pour les tests pédiatriques du panneau T2Candida®. T2 Biosystems prévoit de soumettre le panneau T2Resistance pour une autorisation FDA 510(k) au premier trimestre de 2025.
T2 Biosystems (NASDAQ: TTOO) berichtete über vorläufige Ergebnisse für das vierte Quartal und das gesamte Jahr 2024, wobei Rekordprodukteinnahmen von 2,3 Millionen US-Dollar für das vierte Quartal (37% Steigerung) und 8,3 Millionen US-Dollar für 2024 (23% Steigerung) hervorgehoben wurden. Das Unternehmen sicherte sich 27 Verträge für T2Dx® Instrumente im Jahr 2024, darunter 23 internationale und 4 Installationen in den USA.
Wichtige Entwicklungen umfassen einen exklusiven Vertriebsvertrag in den USA mit Cardinal Health, eine erweiterte internationale Präsenz in sechs neuen Märkten und eine Schuldenreduzierung durch Umwandlung eines Darlehens von 30 Millionen US-Dollar in Stammaktien, wodurch die vierteljährlichen Zinszahlungen um 80% gesenkt wurden. Die Liquiditätsposition betrug am 31. Dezember 2024 1,7 Millionen US-Dollar.
Das Unternehmen erhielt FDA 510(k) Freigaben für erweiterte T2Bacteria® Panel-Funktionen sowie für die pädiatrische Testung des T2Candida® Panels. T2 Biosystems plant, das T2Resistance Panel im ersten Quartal 2025 zur FDA 510(k)-Freigabe einzureichen.
- Record product revenues: Q4 $2.3M (+37% YoY) and FY2024 $8.3M (+23% YoY)
- Secured 27 new T2Dx® Instrument contracts in 2024
- Exclusive U.S. distribution agreement with Cardinal Health
- Debt reduction: Converted $30M term loan to equity, reducing quarterly interest by 80%
- Expanded international distribution to six new markets
- Received FDA 510(k) clearances for expanded product capabilities
- Low cash position of $1.7M as of December 31, 2024
Insights
While achieving
The Cardinal Health distribution agreement could be a pivotal catalyst, potentially accelerating revenue growth through expanded market access. However, the current burn rate versus cash position suggests potential near-term financing needs. The expansion of FDA clearances for both T2Bacteria and T2Candida panels adds value to the product portfolio but monetization remains crucial.
The clinical developments represent meaningful progress in sepsis diagnostics. The FDA 510(k) clearance for Acinetobacter baumannii detection is particularly noteworthy as this pathogen is a significant concern in healthcare settings due to its antibiotic resistance. The expansion to pediatric testing for T2Candida enhances the platform's utility in a critical patient population.
The pending T2Resistance Panel FDA submission in Q1 2025 could be transformative, especially given its Breakthrough Device designation. The successful defense of the European patent for direct-from-whole blood detection strengthens IP protection. The collaboration with Prxcision's AI platform aligns with the industry shift toward integrated diagnostic and decision support solutions, potentially improving clinical outcomes and antimicrobial stewardship.
Achieved record fourth quarter and full-year 2024 sepsis product revenues
LEXINGTON, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the fourth quarter and full year ended December 31, 2024.
Full Year 2024 and Recent Commercial Highlights (unaudited)
- Achieved record product revenues of
$2.3 million for the fourth quarter of 2024 and$8.3 million for the full-year 2024, representing increases of37% and23% respectively, compared to the prior year period, driven by record sepsis test sales. - Executed contracts for 27 T2Dx® Instruments in 2024, including 23 T2Dx Instruments for outside the U.S. and 4 T2Dx Instruments for the U.S.
- Entered into a multi-year exclusive U.S. agreement with Cardinal Health, granting Cardinal exclusive rights to sell the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida® Panel, the only FDA-cleared products able to detect sepsis-causing pathogens directly-from-blood.
- Announced co-marketing collaboration with Prxcision, to market the Company’s rapid direct-from-blood diagnostics with Prxcision’s real-time AI-powered decision support platform to combat the escalating crisis of antibiotic resistance.
- Expanded international distribution network to include the Netherlands, Belgium, Qatar, Vietnam, Malaysia, and Indonesia, and re-entered Switzerland.
- Extended multi-year capital equipment supplier agreement with Vizient, Inc., the largest member-driven health care performance improvement company in the US, through March 31, 2026.
- Converted
$30 million of the Company’s term loan with entities affiliated with CRG Servicing, LLC (“CRG”) into T2 Biosystems’ common stock, reducing the Company’s debt and quarterly interest payments by approximately80% over the past year. - Cash and cash equivalents were
$1.7 million as of December 31, 2024.
Full Year 2024 and Recent Pipeline and Clinical Highlights
- Announced plans to license the Company’s proprietary technology to expand its leadership in direct-from-whole-blood detection of sepsis-causing bacterial and fungal pathogens.
- Received FDA 510(k) clearance to expand the pathogen detection capabilities of the FDA-cleared T2Bacteria® Panel to add detection of Acinetobacter baumannii.
- Received FDA 510(k) clearance to expand the use of the FDA-cleared T2Candida® Panel to include pediatric testing.
- Advanced the T2Resistance Panel toward U.S. FDA 510(k) submission, expected to occur during the first quarter of 2025.
- Successfully defended against an opposition filed against a key patent for its direct-from-whole blood detection method in the European Union
- Announced the publication of a new study highlighting the clinical benefits and performance of real-world use of the T2Resistance® Panel in The Journal of Clinical Microbiology.
“We made considerable progress across the business during 2024, increasing our global installed base of T2Dx Instruments, and generating record sales for our sepsis test panels, including record U.S. sales of the T2Bacteria Panel and record international sales of the T2Resistance Panel. We entered into an exclusive U.S. commercial distribution agreement with Cardinal Health during the fourth quarter, which we expect to be a commercial growth driver, and we are training Cardinal’s sales team the week of January 6, 2025,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We are excited by the progress on our product pipeline in 2024, which included FDA 510(k) clearances for the expanded T2Bacteria Panel to include the detection of Acinetobacter baumannii, and the expanded claim for the T2Candida Panel to include pediatric testing. Additionally, we have three pipeline products that have received FDA Breakthrough Device designation, including the U.S. T2Resistance Panel, the T2Lyme Panel, and the Candida auris test. We believe we are well-positioned heading into 2025, and we expect to accelerate our product sales, enhance our operations, and continue to advance our new product pipeline.”
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the Candida auris test, and the T2Lyme™ Panel. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the likelihood that the exclusive U.S. commercial distribution agreement with Cardinal Health will be a commercial growth driver, and our ability to accelerate product sales, enhance our operations, and continue to advance our new product pipeline, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. The preliminary, estimated financial results for the fourth quarter and fiscal year ended 2024 contained in this press release contain forward-looking statements and are subject to the completion of management’s and the audit committee’s final reviews and our other financial closing procedures and are therefore subject to change. The preliminary financial information and estimates included herein have not been examined or reviewed by our independent auditors and they are subject to revision as we prepare our financial statements as of and for the quarter and fiscal year ended December 31, 2024, including all disclosures required by U.S. generally accepted accounting principles. You should not place undue reliance on such preliminary information and estimates because they may prove to be materially inaccurate. While we believe that such preliminary information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
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