Quanterix Delivers Operational and Preliminary Fiscal Highlights | Small business & Finance

“Even though final year introduced incredible challenges for the environment, it also amplified the vital likely of our precision well being technique to address acute troubles affiliated with the unfold of COVID-19 virus and for a longer time-time period health considerations resulting from the infection,” claimed Kevin Hrusovsky, Chairman, Main Government Officer and President, Quanterix and Founder of Powering Precision Wellbeing (PPH). “Our timely pivot to address the pandemic enabled us to preserve our staff harmless and by year-conclusion, produce a sturdy suite of novel COVID-19 screening solutions to assist the struggle in 2021. Our innovations in ultra-sensitive proteomics screening enable leading scientists to tackle crucial COVID troubles and speed up our Neurology resources approach with vital new additions to our assay menu supporting equally Alzheimer’s and COVID-19 study and diagnostics. We enter 2021 with shorter and lengthy-term advancement catalysts fueling our likely to scale our powering precision wellness approach.”

• Awarded an $18.2M agreement with the NIH as a result of its RADx initiative to speed up the continued advancement and scale-up of a novel SARS-CoV-2 antigen examination.
• Gained Fda Unexpected emergency Use Authorizations for novel SARS-COV-2 antigen test (after 12 months-conclude) and for semi-quantitative antibody examination, underscoring our longstanding science-to start with mentality and deep determination to the optimum requirements of excellent and scientific rigor throughout our organization.
• Leveraging the unparalleled ultra-sensitivity of Simoa, enabled several major researchers globally, which includes at the NIH, to start off tackling primary-edge COVID worries, this kind of as establishing prospective for blood primarily based anti-viral endpoints for new drug therapies and comprehending the extended-phrase problems of COVID-19.
• Expanded our differentiated Neurology menu to consist of tau phosphorylated at threonine 181 (pTau-181), a highly certain biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma as very well as released Neuro Multiplex assays associated with a lot of neurodegenerative illnesses yielding significant growth potential. Our biomarker portfolio is now supporting major Alzheimer’s systems globally.
• Novartis’ a number of sclerosis (MS) drug KESIMPTA® (ofatumumab), which utilized Nf-L as secondary endpoint, was accredited by the Food and drug administration.
• Quanterix’ Simoa technological know-how was highlighted in a document 443 new publications in 2020, bringing whole Simoa-distinct inclusions to around 1,120. Also, was invited to current at many marquis symposiums showcasing our Precision Overall health eyesight and opportunity to catalyze asymptomatic medicine.
• Instrument put in foundation improved by 34% to 535, even with access issues posed by COVID-19. This consists of 93 High definition-X placements with above 50% new installations and 84 new SR-X and SP-X placements.
• Solidified Simoa’s technological leadership by accomplishing a 100x sensitivity advancement in a pilot of the digital enzyme-connected immunosorbent assay (ELISA) that powers the Company’s High definition-X ™ and SR-X ™ Extremely-Delicate Biomarker Detection Systems.
• Entered into a non-special royalty-bearing license settlement with Abbott Laboratories, to grant Abbott accessibility to Quanterix’ portfolio of bead-dependent technological know-how patents for use in in-vitro diagnostic (IVD) applications.
• Realized multi-classification income partnership with one of the major multi-nationwide, health care payor groups, with execution of many population surveillance studies, creating beachhead for our eyesight for the foreseeable future of precision medicine, wherever early and non-invasive condition detection has the probable to remodel lifetime and health care expenditures.
• Effectively raised $97.6 million in gross proceeds by our abide by-on providing, further more strengthening our balance sheet with expansion money.
• William Geist joined Quanterix as Chief Running Officer to assist us maintain and developed our sturdy momentum across a lot of digital biomarker platforms.

Preliminary Non-Audited Fiscal Highlights:

• Expects GAAP revenue of $24-26 million Non-GAAP income of $20-22 million. (1)
• Non-GAAP income, which excludes earnings from the RADx contract, represents an maximize of roughly 32% in excess of prior Q4, driven by expansion in Consumables and Accelerator Companies revenue.

• Expects GAAP income of $84-86 million Non-GAAP profits of $67-69 million. (2)
• Non-GAAP income, which excludes income from the RADx contract and the Abbott license arrangement, represents an maximize of close to 20% around prior calendar year, irrespective of COVID consumer exercise and access worries, driven by growth in Accelerator Products and services income.

(1) Non-GAAP income for Q4 excludes roughly $4 million in RADx-associated profits, which is involved in GAAP profits and subject to adjustment pending finalization of deal accounting for Q4.

(2) Non-GAAP revenue for complete 12 months excludes the approximate $4 million in Q4 RADx-relevant profits famous previously mentioned, as well as an extra $1.9 million of RADx revenue and $11.2 million in earnings relating to the Abbott license agreement identified in Q3, all of which is integrated in GAAP income.

The believed unaudited economical success as of and for the fourth quarter and full fiscal year ended December 31, 2020 presented earlier mentioned are preliminary and are subject matter to completion of our quarter-conclusion and year-conclusion closing processes and further more financial evaluate. This preliminary money facts has not been audited by our impartial auditing firm. Our actual success may perhaps differ from these estimates as a end result of the completion of our quarter-finish and year-end closing techniques, critique changes and other developments that may perhaps occur in between now and the time our money outcomes for the fourth quarter and calendar year are finalized.

Presentation at JP Morgan Health care Convention

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Non-GAAP Economical Measures

To complement the Company’s financial earnings presented on a GAAP basis, the Organization has provided facts on non-GAAP earnings. Administration works by using this non-GAAP evaluate to appraise the Company’s running effectiveness in a fashion that will allow for significant interval-to-interval comparison and investigation of traits in its business. Management thinks that this evaluate is critical in comparing latest results with prior period of time benefits and is valuable to investors and money analysts in evaluating the Company’s functioning overall performance. The non-GAAP economic facts introduced listed here should be regarded in conjunction with, and not as a substitute for, the financial details introduced in accordance with GAAP. Traders are inspired to assessment the reconciliation of these non-GAAP measures to their most immediately comparable GAAP economical measures.

Quanterix is a business that’s digitizing biomarker assessment with the intention of advancing the science of precision wellness. The company’s digital wellness answer, Simoa, has the possible to adjust the way in which health care is provided currently by supplying scientists the potential to intently take a look at the continuum from well being to disorder. Quanterix’ technology is intended to permit substantially previously ailment detection, improved prognoses and increased procedure procedures to increase the quality of existence and longevity of the inhabitants for generations to come. The technological innovation is at present getting made use of for research programs in several therapeutic spots, including oncology, neurology, cardiology, inflammation and infectious ailment. The enterprise was set up in 2007 and is situated in Billerica, Massachusetts. For additional facts, remember to go to https://www.quanterix.com.

Ahead-Looking Statements

This push release incorporates ahead-hunting statements inside of the this means of the Private Securities Litigation Reform Act of 1995. Terms these types of as “might,” “will,” “anticipate,” “prepare,” “anticipate,” “estimate,” “intend” and related expressions (as nicely as other text or expressions referencing upcoming situations, disorders or situation) are intended to establish ahead-searching statements. Forward-seeking statements in this information launch are based mostly on Quanterix’ anticipations and assumptions as of the date of this push launch. Just about every of these ahead-hunting statements will involve hazards and uncertainties. Factors that might result in Quanterix’ real effects to vary from individuals expressed or implied in the forward-hunting statements in this press launch are talked over in Quanterix’ filings with the U.S. Securities and Trade Fee, which include the “Danger Elements” sections contained therein. Apart from as demanded by legislation, Quanterix assumes no obligation to update any forward-seeking statements contained herein to reflect any improve in anticipations, even as new information becomes obtainable.

Staci Didner, (407) 734-7325

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Source: Quanterix Company

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PUB: 01/13/2021 08:30 AM/DISC: 01/13/2021 08:30 AM