T2 Biosystems Announces Preliminary Third Quarter 2024 Financial Results

Rhea-AI Summary

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.

Positive

• 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%

Negative

• None.

Insights

Financial Analyst

The preliminary Q3 2024 results for T2 Biosystems show promising growth trends. The 35% year-over-year increase in total revenue to $2.0 million is a positive sign, driven by strong performance in sepsis test and instrument sales. Particularly noteworthy is the 42% growth in sepsis test panel revenue to $1.6 million, indicating growing market adoption of their core products.

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 $2.5 million to $3.5 million in sepsis product revenue represents significant projected growth of 49% to 109% compared to Q4 2023. This outlook, combined with recent FDA clearances and pipeline advancements, paints a picture of a company on a growth trajectory in the rapidly evolving sepsis diagnostics market.

Medical Research Analyst

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 35% increase in total revenue compared to prior year period

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 of 35% 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 of 42% 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 35% compared to the prior year period, which included more than a 200% increase in sales of the T2Bacteria Panel in the U.S., and more than a 75% increase in sales of the T2Dx Instrument in international markets,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “In addition, we successfully defended a key European patent that protects our direct-from-blood detection methods, we received FDA-clearance to market and sell the T2Candida Panel for pediatrics, and we advanced the T2Resistance Panel toward FDA submission which we expect to occur during the fourth quarter of 2024.”

2024 Financial Outlook

The Company now expects fourth quarter 2024 total sepsis product revenue of $2.5 million to $3.5 million, representing growth of 49% to 109% compared to the fourth quarter of 2023. The Company’s 2024 revenue guidance consists entirely of sepsis product revenue and does not include potential sales of the T2Biothreat™ Panel or the T2Lyme™ Panel.

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

What was T2 Biosystems' (TTOO) total revenue for Q3 2024?

T2 Biosystems reported total revenue of $2.0 million for Q3 2024, representing a 35% increase compared to the prior year period.

How much was T2 Biosystems' (TTOO) sepsis test panel revenue in Q3 2024?

T2 Biosystems' sepsis test panel revenue was $1.6 million in Q3 2024, representing a 42% increase compared to the prior year period.

What is T2 Biosystems' (TTOO) revenue guidance for Q4 2024?

T2 Biosystems 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.

What new FDA clearance did T2 Biosystems (TTOO) receive in Q3 2024?

T2 Biosystems received FDA clearance to market the T2Candida® Panel for pediatric patients in Q3 2024.