T2 Biosystems Announces Second Quarter 2024 Financial Results
T2 Biosystems (NASDAQ:TTOO) announced its Q2 2024 financial results, highlighting record quarterly and first half sepsis test revenue, with 27% and 25% growth respectively compared to the prior year. The company achieved total revenue of $2.0 million, all from sepsis product sales. T2 Biosystems executed contracts for 2 T2Dx® Instruments outside the U.S. and signed multiple international distribution agreements. The company also strengthened its balance sheet by converting $30.0 million of term loan debt and raised $8.0 million through a private placement stock sale.
Key pipeline developments include completing clinical studies for the T2Lyme Panel, submitting a 510(k) for pediatric testing with the T2Candida® Panel, and advancing the T2Resistance Panel toward FDA submission. The company reiterated its 2024 financial outlook, expecting full year sepsis product revenue of $10.0 million to $11.0 million, representing 49% to 64% growth compared to 2023.
T2 Biosystems (NASDAQ:TTOO) ha annunciato i risultati finanziari del secondo trimestre del 2024, evidenziando entrate record trimestrali e nel primo semestre dai test per la sepsi, con una crescita rispettivamente del 27% e del 25% rispetto all'anno precedente. L'azienda ha raggiunto un fatturato totale di 2,0 milioni di dollari, tutto proveniente dalle vendite di prodotti per la sepsi. T2 Biosystems ha eseguito contratti per 2 strumenti T2Dx® al di fuori degli Stati Uniti e ha firmato diversi accordi di distribuzione internazionale. Inoltre, l'azienda ha rafforzato il proprio bilancio convertendo 30,0 milioni di dollari di debito del prestito a termine e ha raccolto 8,0 milioni di dollari tramite la vendita di azioni in private placement.
Sviluppi chiave nel pipeline includono il completamento degli studi clinici per il T2Lyme Panel, la presentazione di un 510(k) per il test pediatrico con il T2Candida® Panel e l'avanzamento del T2Resistance Panel verso la submission alla FDA. L'azienda ha ribadito le proprie aspettative finanziarie per il 2024, prevedendo entrate annuali dai prodotti per la sepsi di 10,0 milioni a 11,0 milioni di dollari, con una crescita compresa tra il 49% e il 64% rispetto al 2023.
T2 Biosystems (NASDAQ:TTOO) anunció sus resultados financieros del segundo trimestre de 2024, destacando ingresos récord trimestrales y del primer semestre por pruebas de sepsis, con un crecimiento del 27% y del 25% respectivamente en comparación con el año anterior. La compañía logró ingresos totales de 2.0 millones de dólares, todos procedentes de ventas de productos para la sepsis. T2 Biosystems ejecutó contratos para 2 instrumentos T2Dx® fuera de EE.UU. y firmó múltiples acuerdos de distribución internacional. La empresa también fortaleció su balance al convertir 30.0 millones de dólares de deuda de préstamo a plazo y recaudó 8.0 millones de dólares mediante la venta privada de acciones.
Los desarrollos clave en el pipeline incluyen la finalización de estudios clínicos para el T2Lyme Panel, la presentación de un 510(k) para pruebas pediátricas con el T2Candida® Panel, y el avance del T2Resistance Panel hacia la presentación ante la FDA. La compañía reiteró su pronóstico financiero para 2024, esperando ingresos por productos de sepsis de 10.0 millones a 11.0 millones de dólares, lo que representa un crecimiento del 49% al 64% en comparación con 2023.
T2 바이오시스템(TNASDAQ:TTOO)은 2분기 2024 재무 결과를 발표하면서 역대 분기 및 상반기 패혈증 검사 수익이 각각 27% 및 25% 성장했다고 강조했습니다. 회사는 총 200만 달러의 수익을 기록했으며, 이는 모두 패혈증 제품 판매에서 발생했습니다. T2 바이오시스템은 미국 외부에서 2개의 T2Dx® 기기를 위한 계약을 체결하고 여러 국제 유통 계약을 체결했습니다. 또한, 3천만 달러의 장기 대출 부채를 전환하고, 800만 달러를 프라이빗 플레시먼트 주식 판매를 통해 모금함으로써 재무 상태를 강화했습니다.
주요 파이프라인 개발에는 T2Lyme 패널에 대한 임상 연구 완료, T2Candida® 패널을 사용한 소아 검사에 대한 510(k) 제출, T2Resistance 패널의 FDA 제출을 위한 진전이 포함되어 있습니다. 회사는 2024년 재무 전망을 재확인하며, 패혈증 제품 연간 수익이 1000만에서 1100만 달러에 이를 것으로 예상하고 있으며, 이는 2023년에 비해 49%에서 64% 성장할 것으로 보입니다.
T2 Biosystems (NASDAQ:TTOO) a annoncé ses résultats financiers pour le deuxième trimestre 2024, mettant en évidence des revenus trimestriels et semestriels record pour les tests de sepsis, avec une croissance de 27 % et 25 % respectivement par rapport à l'année précédente. L'entreprise a réalisé un chiffre d'affaires total de 2,0 millions de dollars, provenant entièrement des ventes de produits de sepsis. T2 Biosystems a exécuté des contrats pour deux instruments T2Dx® en dehors des États-Unis et a signé plusieurs accords de distribution internationale. De plus, l'entreprise a renforcé son bilan en convertissant 30,0 millions de dollars de dettes de prêt à terme et a levé 8,0 millions de dollars par le biais d'une vente d'actions en placement privé.
Les développements clés du pipeline incluent l'achèvement d'études cliniques pour le T2Lyme Panel, la soumission d'un 510(k) pour des tests pédiatriques avec le T2Candida® Panel, et l'avancement du T2Resistance Panel vers une soumission à la FDA. L'entreprise a réaffirmé ses prévisions financières pour 2024, s'attendant à des revenus totaux de produits de sepsis de 10,0 millions à 11,0 millions de dollars, représentant une croissance de 49 % à 64 % par rapport à 2023.
T2 Biosystems (NASDAQ:TTOO) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 angekündigt, wobei Rekordeinnahmen aus Sepsistests im Quartal und im ersten Halbjahr hervorgehoben werden, mit einem Wachstum von 27% und 25% im Vergleich zum Vorjahr. Das Unternehmen erzielte Gesamteinnahmen von 2,0 Millionen Dollar, die alle aus dem Verkauf von Sepsisprodukten stammten. T2 Biosystems setzte Verträge für 2 T2Dx®-Instrumente außerhalb der USA um und unterzeichnete mehrere internationale Vertriebsvereinbarungen. Das Unternehmen stärkte auch seine Bilanz, indem es 30,0 Millionen Dollar von einem Terminkredit umwandelte und 8,0 Millionen Dollar durch den Verkauf von Aktien im Rahmen einer Privatplatzierung einbrachte.
Zu den wichtigen Pipeline-Entwicklungen gehören der Abschluss klinischer Studien für das T2Lyme-Panel, die Einreichung eines 510(k) für pädiatrische Tests mit dem T2Candida®-Panel und der Fortschritt des T2Resistance-Panels in Richtung FDA-Einreichung. Das Unternehmen bekräftigte seine Finanzprognose für 2024 und erwartet für das Gesamtjahr Einnahmen aus Sepsisprodukten zwischen 10,0 Millionen und 11,0 Millionen Dollar, was einem Wachstum von 49% bis 64% im Vergleich zu 2023 entspricht.
- Record quarterly and first half sepsis test revenue, with 27% and 25% growth respectively
- Executed contracts for 2 T2Dx® Instruments and 6 additional instruments in July 2024
- Signed multiple international distribution agreements in the Middle East and Asia
- Converted $30.0 million of term loan debt, reducing total debt and quarterly interest payments by approximately 80%
- Raised $8.0 million in gross proceeds through a private placement stock sale
- 27% improvement in loss from operations compared to Q2 2023
- Completed clinical studies for T2Lyme Panel and submitted 510(k) for T2Candida® Panel pediatric testing
- Total revenue remained flat at $2.0 million compared to the prior year period
- Net loss of $9.2 million in Q2 2024, compared to $6.3 million in Q2 2023
- Cash and cash equivalents decreased to $4.2 million as of June 30, 2024, from $6.2 million as of March 31, 2024
T2 Biosystems' Q2 2024 results present a mixed picture. The company achieved record quarterly and first-half sepsis test revenue, growing
However, total revenue remained flat at
The company's efforts to strengthen its balance sheet are noteworthy. By converting
Operating loss improved by
The reiterated 2024 guidance of
T2 Biosystems' focus on rapid detection of sepsis-causing pathogens and antibiotic resistance genes positions it well in the critical field of sepsis management. The record sales of T2Bacteria® and T2Resistance® panels underscore the clinical need for rapid, culture-independent diagnostic tools in sepsis care.
The company's pipeline developments are promising. The completion of clinical studies for the T2Lyme Panel, set to launch as a laboratory developed test (LDT) in Q3 2024, could open up a new market segment. Lyme disease diagnosis is notoriously challenging and a rapid, accurate test could significantly impact patient care.
The submission of a 510(k) premarket notification to expand the T2Candida® Panel to pediatric testing is another positive step. Invasive candidiasis in children is a serious concern and expanding the panel's use to this population could improve outcomes and expand the product's market.
The advancement of the T2Resistance Panel toward FDA 510(k) submission is crucial. With antibiotic resistance being a global health threat, a rapid test for resistance genes could be a game-changer in appropriate antibiotic stewardship.
The new data presented at ASM Microbe 2024 demonstrating the clinical benefits of the culture-independent T2Candida Panel further validates the company's technology. As healthcare systems increasingly recognize the importance of rapid diagnostics in sepsis management, T2 Biosystems' products could see increased adoption.
However, it's important to note that the company faces competition in the molecular diagnostics space and the success of its products will depend on their performance in real-world clinical settings and the company's ability to effectively market them to healthcare providers.
Achieved record quarterly and first half sepsis test revenue, representing growth of
LEXINGTON, Mass., July 29, 2024 (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 financial and operational results for the second quarter ended June 30, 2024.
Recent Financial and Operational Highlights
- Achieved second quarter 2024 total revenue of
$2.0 million , all from sepsis product sales. - Achieved record quarterly and first half sepsis test revenue, representing growth of
27% and25% respectively compared to the prior year periods, led by T2Bacteria® and T2Resistance® panel sales. - Executed contracts for 2 T2Dx® Instruments during the second quarter, both from outside the U.S., and have executed contracts for 6 additional instruments in July 2024.
- Signed multiple international distribution agreements in the Middle East and Asia, including Qatar, Hong Kong, Malaysia, Indonesia, and Macau.
- Strengthened balance sheet by converting
$30.0 million of term loan debt with CRG Servicing LLC (“CRG”) in exchange for T2 Biosystems equity, reducing both total debt and quarterly interest payments to CRG by approximately80% percent from May 2023 amounts. - Raised
$8.0 million in gross proceeds through a private placement stock sale executed in May 2024. $9.6 million loss from operations in the second quarter of 2024, a27% improvement compared to$13.1 million in the second quarter of 2023.
Recent Pipeline and Clinical Highlights
- Completed clinical studies required to launch the T2Lyme Panel as a laboratory developed test (LDT) in the third quarter of 2024.
- Submitted a 510(k) premarket notification to the U.S. FDA to expand the use of the T2Candida® Panel to include pediatric testing.
- Advanced the T2Resistance Panel toward U.S. FDA 510(k) submission, now expected to occur during the fourth quarter of 2024.
- Presented new data at the American Society for Microbiology (ASM) Microbe 2024 conference demonstrates the clinical benefits of the culture-independent T2Candida Panel.
“We are highly encouraged by the record second quarter and record first half of 2024 sepsis test revenue, driven by increased sales of the T2Bacteria Panel, which can be attributed to effective commercial execution,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Moving forward, we expect incremental sepsis revenue growth as a result of the recently FDA-cleared expanded T2Bacteria Panel, to include the detection of Acinetobacter baumannii, potential U.S. distribution partnership with a multibillion dollar healthcare company, and recently signed international distribution agreements in five new countries. We believe the launch of the T2Lyme Panel as a Laboratory Developed Test (LDT), planned for the third quarter of 2024, represents a significant growth opportunity. Finally, we continue to prioritize enhancing our operations and implementing cost reduction measures to improve cash flow.”
Second Quarter 2024 Financial Results
Total revenue for the second quarter of 2024 was
Cost of product revenue for the second quarter of 2024 was
Loss from operations was
Net loss for the second quarter of 2024 was
Cash and cash equivalents totaled
Reiterated 2024 Financial Outlook
The Company continues to expect full year 2024 total sepsis product revenue of
Webcast and Conference Call Information
The Company’s management team will host a conference call today, July 29, 2024, beginning at 4:30 pm ET. Investors interested in listening to the call may do so by dialing 888-506-0062 for domestic callers or 973-528-0011 for International callers and using conference ID 109834 approximately five minutes prior to the start time. A live and recorded webcast of the call will be available on the “Investors” section of the Company’s website at www.t2biosystems.com.
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, statements about global commercial expansion and international strategy, and the potential for strong growth in the region, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. The financial information included herein 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 June 30, 2024, including all disclosures required by U.S. generally accepted accounting principles. While we believe that such 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
| T2 Biosystems, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (In thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,246 | $ | 15,689 | ||||
| Accounts receivable, net | 1,297 | 1,420 | ||||||
| Inventories | 5,169 | 4,819 | ||||||
| Prepaid expenses and other current assets | 2,283 | 3,261 | ||||||
| Total current assets | 12,995 | 25,189 | ||||||
| Property and equipment, net | 1,517 | 1,658 | ||||||
| Operating lease right-of-use assets | 6,656 | 7,395 | ||||||
| Restricted cash | 551 | 551 | ||||||
| Other assets | 1 | 4 | ||||||
| Total assets | $ | 21,720 | $ | 34,797 | ||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Notes payable to related party | $ | 11,787 | $ | 41,284 | ||||
| Accounts payable | 1,686 | 1,527 | ||||||
| Accrued expenses and other current liabilities | 4,276 | 4,905 | ||||||
| Accrued final payment fee on Term Loan with related party | 1,315 | 4,807 | ||||||
| Operating lease liability | 1,687 | 1,616 | ||||||
| Derivative liability related to Term Loan with related party | 424 | 1,554 | ||||||
| Derivative liabilities with placement agent | 894 | — | ||||||
| Warrant liabilities | 1,091 | 235 | ||||||
| Deferred revenue | 237 | 224 | ||||||
| Total current liabilities | 23,397 | 56,152 | ||||||
| Operating lease liabilities, net of current portion | 5,746 | 6,598 | ||||||
| Deferred revenue, net of current portion | 74 | 83 | ||||||
| Total liabilities | 29,217 | 62,833 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit | ||||||||
| Common stock, | 17 | 4 | ||||||
| Additional paid-in capital | 599,559 | 556,256 | ||||||
| Accumulated deficit | (607,073 | ) | (584,296 | ) | ||||
| Total stockholders’ deficit | (7,497 | ) | (28,036 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 21,720 | $ | 34,797 | ||||
| T2 Biosystems, Inc. | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 1,952 | $ | 1,964 | $ | 4,013 | $ | 3,619 | ||||||||
| Contribution revenue | — | — | — | 423 | ||||||||||||
| Total revenue | 1,952 | 1,964 | 4,013 | 4,042 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product revenue | 2,693 | 4,869 | 6,895 | 8,864 | ||||||||||||
| Research and development | 3,361 | 3,850 | 7,082 | 8,321 | ||||||||||||
| Selling, general and administrative | 5,473 | 6,296 | 12,211 | 13,595 | ||||||||||||
| Total costs and expenses | 11,527 | 15,015 | 26,188 | 30,780 | ||||||||||||
| Loss from operations | (9,575 | ) | (13,051 | ) | (22,175 | ) | (26,738 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense to related party | (478 | ) | (1,541 | ) | (1,657 | ) | (3,063 | ) | ||||||||
| Change in fair value of derivative related to Term Loan with related party | 1,238 | 1,022 | 1,130 | 252 | ||||||||||||
| Change in fair value of derivatives with placement agent | (322 | ) | — | (322 | ) | — | ||||||||||
| Change in fair value of warrant liabilities | (138 | ) | 7,192 | (110 | ) | 5,888 | ||||||||||
| Other, net | 32 | 31 | 357 | (651 | ) | |||||||||||
| Total other income (expense) | 332 | 6,704 | (602 | ) | 2,426 | |||||||||||
| Net loss | $ | (9,243 | ) | $ | (6,347 | ) | $ | (22,777 | ) | $ | (24,312 | ) | ||||
| Net loss per share — basic and diluted | $ | (0.66 | ) | $ | (7.84 | ) | $ | (2.37 | ) | $ | (51.23 | ) | ||||
| Weighted-average number of common shares used in computing net loss per share — basic and diluted | 14,095,348 | 809,168 | 9,595,079 | 474,609 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | $ | (9,243 | ) | $ | (6,347 | ) | $ | (22,777 | ) | $ | (24,312 | ) | ||||
| Total other comprehensive income, net of taxes | — | — | — | — | ||||||||||||
| Comprehensive loss | $ | (9,243 | ) | $ | (6,347 | ) | $ | (22,777 | ) | $ | (24,312 | ) | ||||
FAQ
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