T2 Biosystems Announces Preliminary Third Quarter 2024 Financial Results
T2 Biosystems (NASDAQ: TTOO) announced preliminary unaudited financial results for Q3 2024, reporting a 35% increase in total revenue compared to the prior year period. Key highlights include:
- Total revenue of $2.0 million
- Sepsis test panel revenue of $1.6 million, up 42% year-over-year
- Executed contracts for 11 T2Dx® Instruments
- Expanded international distribution to Malaysia and Indonesia
- Received FDA clearance for T2Candida® Panel for pediatric patients
- Advanced T2Resistance® Panel toward FDA 510(k) submission
The company expects Q4 2024 total sepsis product revenue of $2.5 million to $3.5 million, representing growth of 49% to 109% compared to Q4 2023.
T2 Biosystems (NASDAQ: TTOO) ha annunciato risultati finanziari preliminari non verificati per il Q3 2024, riportando un aumento del 35% del fatturato totale rispetto allo stesso periodo dell'anno precedente. I punti salienti includono:
- Fatturato totale di $2,0 milioni
- Fatturato del pannello test per sepsi di $1,6 milioni, in aumento del 42% anno su anno
- Contratti eseguiti per 11 strumenti T2Dx®
- Espansione della distribuzione internazionale in Malesia e Indonesia
- Ottenuto l'approvazione della FDA per il pannello T2Candida® per pazienti pediatrici
- Avanzamento del pannello T2Resistance® verso la presentazione 510(k) della FDA
L'azienda prevede un fatturato totale per prodotti sepsi nel Q4 2024 di $2,5 milioni a $3,5 milioni, rappresentando una crescita dal 49% al 109% rispetto al Q4 2023.
T2 Biosystems (NASDAQ: TTOO) anunció resultados financieros preliminares no auditados para el Q3 2024, reportando un aumento del 35% en los ingresos totales en comparación con el mismo período del año anterior. Los aspectos destacados incluyen:
- Ingresos totales de $2,0 millones
- Ingresos del panel de pruebas de sepsis de $1,6 millones, un 42% más en comparación con el año anterior
- Contratos ejecutados para 11 instrumentos T2Dx®
- Expansión de la distribución internacional a Malasia e Indonesia
- Aprobación de la FDA para el panel T2Candida® para pacientes pediátricos
- Avance del panel T2Resistance® hacia la presentación 510(k) a la FDA
La empresa espera ingresos totales por productos de sepsis de $2,5 millones a $3,5 millones en el Q4 2024, lo que representa un crecimiento del 49% al 109% en comparación con el Q4 2023.
T2 바이오시스템즈 (NASDAQ: TTOO)는 2024년 3분기 비공식 예비 재무 결과를 발표하며 총 수익이 35% 증가했다고 보고했습니다. 주요 하이라이트는 다음과 같습니다:
- 총 수익 $2.0 백만
- 패혈증 테스트 패널 수익 $1.6 백만, 전년 대비 42% 증가
- 11개의 T2Dx® 기기에 대한 계약 체결
- 말레이시아와 인도네시아로의 국제 유통 확대
- 소아 환자를 위한 T2Candida® 패널에 대한 FDA 승인 확보
- FDA 510(k) 제출을 위한 T2Resistance® 패널 진전
회사는 2024년 4분기 총 패혈증 제품 수익이 $2.5 백만에서 $3.5 백만에 이르러 2023년 4분기 대비 49%에서 109% 성장할 것으로 예상하고 있습니다.
T2 Biosystems (NASDAQ: TTOO) a annoncé des résultats financiers préliminaires non audités pour le T3 2024, signalant une augmentation de 35% des revenus totaux par rapport à la période de l'année précédente. Les points saillants incluent :
- Revenus totaux de $2,0 millions
- Revenus du panel de test pour la sepsie de $1,6 million, en hausse de 42% d'une année sur l'autre
- Contrats exécutés pour 11 instruments T2Dx®
- Distribution internationale étendue en Malaisie et en Indonésie
- Obtention de l'approbation de la FDA pour le panel T2Candida® pour les patients pédiatriques
- Avancement du panel T2Resistance® vers la soumission 510(k) à la FDA
L'entreprise prévoit des revenus totaux de produits pour la sepsie de $2,5 millions à $3,5 millions pour le T4 2024, représentant une croissance de 49% à 109% par rapport au T4 2023.
T2 Biosystems (NASDAQ: TTOO) hat vorläufige, nicht geprüfte Finanzzahlen für das 3. Quartal 2024 veröffentlicht und meldet ein Wachstum der Gesamteinnahmen um 35% im Vergleich zum Vorjahreszeitraum. Wichtige Highlights sind:
- Gesamteinnahmen von $2,0 Millionen
- Einnahmen aus dem Sepsis-Testpanel von $1,6 Millionen, was einem Anstieg von 42% im Jahresvergleich entspricht
- Ausgeführte Verträge für 11 T2Dx® Instrumente
- Internationale Distribution auf Malaysia und Indonesien ausgeweitet
- FDA-Freigabe für das T2Candida® Panel für pädiatrische Patienten erhalten
- Fortschritt des T2Resistance® Panels zur FDA 510(k) Einreichung
Das Unternehmen erwartet im 4. Quartal 2024 Gesamteinnahmen aus Sepsisprodukten von $2,5 Millionen bis $3,5 Millionen, was einem Wachstum von 49% bis 109% im Vergleich zum 4. Quartal 2023 entspricht.
- 35% increase in total revenue compared to prior year period
- 42% increase in sepsis test panel revenue year-over-year
- Executed contracts for 11 T2Dx® Instruments
- Expanded international distribution to Malaysia and Indonesia
- Received FDA clearance for T2Candida® Panel for pediatric patients
- Projected Q4 2024 sepsis product revenue growth of 49% to 109%
- None.
Insights
The preliminary Q3 2024 results for T2 Biosystems show promising growth trends. The 35% year-over-year increase in total revenue to
The execution of contracts for 11 T2Dx Instruments, with 10 being international, suggests expanding global market penetration. This aligns with their strategy to grow their international distribution network, as evidenced by the new exclusive distribution agreement for Malaysia and Indonesia.
Looking ahead, the company's Q4 2024 guidance of
T2 Biosystems' recent developments demonstrate progress in both product approval and scientific validation. The FDA clearance for the T2Candida Panel for pediatric use expands their addressable market. The advancement of the T2Resistance Panel toward FDA 510(k) submission, expected in Q4 2024, could potentially add another revenue stream if approved.
The successful defense of a key European patent for their direct-from-blood pathogen detection method against bioMerieux's opposition strengthens their intellectual property position. This is important for maintaining a competitive edge in the rapidly evolving diagnostics field.
The publication in The Lancet highlighting the limitations of blood culture and advocating for culture-independent diagnostics aligns with T2 Biosystems' technology. This third-party validation from a prestigious medical journal could influence adoption rates among healthcare providers, potentially driving future sales growth. The company's focus on rapid sepsis detection addresses a critical need in healthcare, positioning them well in a high-stakes market.
Achieved
LEXINGTON, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the third quarter 2024.
Recent Financial and Operational Highlights (unaudited)
- Achieved third quarter total revenue of
$2.0 million , representing an increase of35% compared to the prior year period, driven by increased sepsis test revenue and instrument revenue. - Achieved sepsis test panel revenue of
$1.6 million , representing an increase of42% compared to the prior year period, driven by increased T2Bacteria® Panel revenue in the U.S. - Executed contracts for 11 T2Dx® Instruments during the third quarter, including 1 in the U.S. and 10 internationally.
- Expanded international distribution network by entering into an exclusive distribution agreement covering Malaysia and Indonesia.
Recent Pipeline and Clinical Highlights
- Received clearance from the U.S. Food and Drug Administration (FDA) to market the T2Candida® Panel for pediatric patients.
- Advanced the T2Resistance® Panel toward U.S. FDA 510(k) submission which is expected to occur during the fourth quarter of 2024.
- Defended successfully against an opposition of a key patent for the Company’s innovative direct-from-blood pathogen detection method filed with the European Patent Office by bioMerieux.
- The article “Changing the Culture of Blood Culture” recently published in The Lancet, a world-leading medical journal, highlighted the weaknesses of blood culture, and the ideal characteristics of culture-independent diagnostics consistent with the features and benefits provided by the T2Bacteria Panel, the T2Candida Panel, and the T2Resistance Panel.
“During the third quarter, our team delivered total revenue growth of
2024 Financial Outlook
The Company now expects fourth quarter 2024 total sepsis product revenue of
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 are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. 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, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. The preliminary financial results for the third quarter 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. You should not place undue reliance on such preliminary information and estimates because they may prove to be materially inaccurate. The preliminary information and estimates have not been compiled or examined by our independent auditors and they are subject to revision as we prepare our financial statements as of and for the quarter ended September 30, 2024, including all disclosures required by U.S. generally accepted accounting principles. 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) continue to operate as a going concern and raise additional debt or equity financing necessary to fund working capital, make capital expenditures and service our debt, (b) realize anticipated benefits from commitments, contracts or products; (c) successfully execute strategic priorities; (d) bring products to market; (e) expand product usage or adoption; (f) obtain customer testimonials; (g) accurately predict growth assumptions; (h) realize anticipated revenues; (i) incur expected levels of operating expenses; or (j) 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
FAQ
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