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Washington, D.C. 20549





Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): March 6, 2023



(Exact name of registrant as specified in its charter)


Delaware 001-38319 20-8957988
(State or other jurisdiction
of incorporation)
(Commission File Number) (IRS Employer
Identification No.)


900 Middlesex Turnpike
Billerica, MA
(Address of principal executive offices) (Zip Code)


Registrant’s telephone number, including area code: (617) 301-9400


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class  Trading symbol(s)  Name of each exchange on which
Common Stock, $0.001 par value per share  QTRX  The Nasdaq Global Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 


Emerging Growth Company ¨


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨





Item 2.02 Results of Operations and Financial Condition.


On March 6, 2023, Quanterix Corporation (“Quanterix”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2022 (the “Earnings Release”).  A copy of the Earnings Release is furnished as Exhibit 99.1 and is incorporated herein by reference.


Item 7.01. Regulation FD Disclosure


A copy of a slide to be presented during Quanterix’s earnings call on March 6, 2023 is furnished as Exhibit 99.2 and is incorporated herein by reference.


The information in this Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits





99.1   Earnings Release dated March 6, 2023.
99.2   Slide from March 6, 2023 Earnings Call.
104   Cover Page Interactive Data File (embedded within the inline XBRL document)







Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


  By: /s/ Michael Doyle
    Michael Doyle
    Chief Financial Officer


Date: March 6, 2023





Exhibit 99.1


Quanterix Releases Operating Results for Fourth Quarter and Full Year 2022; Aligned with Expectations


Corporate Transformation:



BILLERICA, Mass.- March 6, 2023 - Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced financial results for the fourth quarter and twelve months ended December 31, 2022.


“Our Simoa technology continues to be on the forefront of research, testing, therapeutic trials and has been an integral part of recent advances in Alzheimer’s disease. In order to best capture and lead in this area, two quarters ago we began a corporate transformation and we’re pleased announce the program is on track, with good progress quarter over quarter, said Masoud Toloue, President and Chief Executive Officer of Quanterix.


Sequential Progress with Strategic Business Realignment


In August 2022, the Company initiated a strategic business realignment to maximize its full potential to enable access to current and future Simoa technology. As part of the realignment, the Company established an assay redevelopment program with the goal of improving its capability to manufacture high-quality assays at scale.


Quanterix’s fourth quarter and full year revenue results were in line with expectations set forth with this plan. Gross margin, a key success indicator of the Company’s strategic realignment, saw strong quarter over quarter improvement. Q4 GAAP Gross Margin was 48.8% versus Q3 GAAP gross margin of 41.1%. Q4 Non-GAAP gross margin was 41.3% versus Q3 non-GAAP gross margin of 34.9%.


GAAP Operating loss of $22.3 million for the fourth quarter of 2022 included approximately $10 million of restructuring and impairment related charges. As a result of the restructuring, SG&A costs were $19.3M for the quarter, down $9.1M from last year Q4.





Year over Year Financial Highlights


Fourth Quarter 2022


·Q4 GAAP revenue was $25.8 million versus prior year Q4 of $30.3 million, a decrease of 14.7%. Prior year Q4 revenue included $1.0M of RADx revenue.

·Q4 GAAP gross margin was 48.8% versus prior year Q4 of 53.7%; Q4 non-GAAP gross margin was 41.3% versus prior year Q4 of 47.2%.

·Cash burn for Q4 was $5 million, ended 2022 with $338.7 million of unrestricted cash.


Full Year 2022


·FY GAAP total revenue was $105.5 million versus prior year FY of $110.6 million, which included RADx revenue of $5.2 million.

·FY GAAP gross margin was 44.4% versus prior year FY of 55.8%; and FY non-GAAP gross margin was 37.5% versus prior year FY of 49.6%


For additional information on the non-GAAP financial measures included in this press release, please see “Use of Non-GAAP Financial Measures” and “Reconciliation of GAAP to Non-GAAP Financial Measures” below.


Fourth Quarter and Full Year Business Highlights


·In Q1 2022, Quanterix announced new agreements with Lilly to advance Alzheimer’s disease diagnosis and treatment; the agreements provide Quanterix access to Lilly’s P-tau217 antibody technology to create pathways for plasma-based biomarkers for use in Alzheimer’s disease and establish a framework for future collaboration and supports development of Quanterix tests to advance diagnosing and treating life-threatening diseases.


·In Q2 2022, the Company received funding from the Alzheimer’s Drug Discovery Foundation to accelerate Alzheimer’s disease diagnostic plasma test development. The Company is collaborating with Amsterdam University Medical Centers on four phases of clinical trials to validate Quanterix’s multi-analyte test. Phase 1 training cohort was completed in Q4 with 1,200 samples and Phase 1b (independent retrospective cohort) and Phase 2 (prospective trial) are expected to start by the end of Q1 2023.


·The Company is participating in the BioHermes trial with the Global Alzheimer’s Platform Foundation. The 17 US site and 1,000 early Alzheimer’s patient trial closed in November of 2022 and is expected to complete data analysis in Q2 of this year. This prospective validation trial is expected to support a regulatory filing for FDA clearance for Quanterix’s pTau-181 test.


·In Q4 2022, the Company presented findings at the 15th Clinical Trials on Alzheimer’s Disease conference, revealing that Quanterix’s Simoa® technology has powered critical advances in ongoing clinical trials for the treatment of Alzheimer’s disease.


·The Company expanded its LDT menu with the launch of a neurofilament light chain (NfL) LDT, which can be used as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage. Quanterix’s Simoa NfL is the most widely published NfL test with hundreds of research papers, demonstrating its validity for assessing neuronal damage, and Simoa NfL has become widely adopted in therapeutic clinical trial designs.





·Published discoveries enabled through Quanterix’s Simoa technology continue to illustrate industry reliance on the Company’s ultra-sensitive technology for breakthrough discovery in research and clinical applications. The technology was highlighted in 137 new publications in the fourth quarter 2022, bringing total Simoa-specific inclusions to over 2,100 as of the end of 2022.


Conference Call


In conjunction with this announcement, Quanterix Corporation will host a conference call on March 6, 2023 at 8:30 a.m. Eastern Time. Individuals interested in listening to the conference call may do so by pre-registering here and obtaining a dial-in number and passcode.


A live webcast will also be available at: https://edge.media-server.com/mmc/p/e6rxupm5 . You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.


Financial Highlights


Quanterix Corporation

Condensed Consolidated Statements of Operations

(Unaudited and in thousands, except share and per share data)


   Three Months Ended December 31,   Year Ended December 31, 
   2022   2021   2022   2021 
Product revenue  $16,674   $23,476   $69,808   $81,062 
Service and other revenue   8,767    5,674    34,495    23,629 
Collaboration revenue   170    162    649    648 
Grant revenue   213    975    570    5,217 
Total revenue   25,824    30,287    105,522    110,556 
Costs of goods sold:                    
Cost of product revenue   9,631    9,916    40,809    34,149 
Cost of service and other revenue   3,601    4,110    17,907    14,679 
Total costs of goods sold and services   13,232    14,026    58,716    48,828 
Gross profit   12,592    16,261    46,806    61,728 
Gross margin   48.8%   53.7%   44.4%   55.8%
Operating expenses:                    
Research and development   5,600    7,734    25,890    27,978 
Selling, general and administrative   19,272    28,423    91,995    92,336 
Other lease costs   669        1,278     
Restructuring   329        3,755     
Goodwill impairment           8,220     
Impairment expense   8,677        17,372     
Total operating expenses   34,547    36,157    148,510    120,314 
Loss from operations   (21,955)   (19,896)   (101,704)   (58,586)
Interest income (expense), net   2,815    15    5,131    (403)
Other income (expense), net   614    (213)   (62)   1,265 
Loss before income taxes   (18,526)   (20,094)   (96,635)   (57,724)
Income tax (expense) benefit   (75)   4    (65)   36 
Net loss  $(18,601)  $(20,098)  $(96,700)  $(57,760)
Net loss per share, basic and diluted  $(0.50)  $(0.55)  $(2.61)  $(1.60)
Weighted-average common shares outstanding, basic and diluted   37,160,472    36,659,254    36,990,965    35,997,473 





Quanterix Corporation

Condensed Consolidated Balance Sheets

(Unaudited and in thousands)


   December 31, 2022   December 31, 2021 
Current assets:          
Cash and cash equivalents  $338,740   $396,465 
Accounts receivable, net   19,017    23,786 
Inventory   16,786    22,190 
Prepaid expenses and other current assets   6,860    6,514 
Total current assets   381,403    448,955 
Restricted cash   2,597    2,577 
Property and equipment, net   20,162    17,960 
Intangible assets, net   7,516    10,534 
Goodwill       9,632 
Right-of-use assets   21,223    11,491 
Other non-current assets   1,298    378 
Total assets  $434,199   $501,527 
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $3,836   $9,209 
Accrued compensation and benefits   10,658    13,252 
Other accrued expenses   4,747    6,486 
Deferred revenue   8,644    6,361 
Short-term lease liabilities   2,687    1,428 
Other current liabilities   386    241 
Total current liabilities   30,958    36,977 
Deferred revenue, net of current portion   1,415    1,099 
Long-term lease liabilities   41,417    20,464 
Other non-current liabilities   1,469    2,035 
Total liabilities   75,259    60,575 
Total stockholders’ equity   358,940    440,952 
Total liabilities and stockholders’ equity  $434,199   $501,527 





Use of Non-GAAP Financial Measures


To supplement its financial statements presented on a GAAP basis, the Company presents non-GAAP gross profit and non-GAAP gross margin, which are calculated by including shipping and handling costs for product sales within cost of goods sold instead of within selling, general and administrative expenses. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends between the Company’s business and its competitors. Management believes that presentation of non-GAAP gross margin provides useful information to investors in assessing the Company’s operating performance within its industry and in order to allow comparability to the presentation of other companies in its industry where shipping and handling costs are included in cost of goods sold for products. Management also uses non-GAAP gross margin as a factor in assessing the Company’s progress against the strategic business realignment plan. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these pro-forma measures to their most directly comparable GAAP financial measures set forth below.


Reconciliation of GAAP to Non-GAAP Financial Measures


Quanterix Corporation

Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures

(Unaudited and in thousands, except percentages)


   Three Months Ended December 31,   Three Months Ended
September 30,
   Three Months Ended
June 30,
   Year Ended December 31, 
   2022   2021   2022   2022   2022   2021 
GAAP gross profit  $12,592   $16,261   $10,944   $8,711   $46,806   $61,728 
Shipping and handling costs (1)   (1,926)   (1,976)   (1,636)   (1,868)   (7,206)   (6,892)
Non-GAAP gross profit  $10,666   $14,285   $9,308   $6,843   $39,600   $54,836 
GAAP Revenue   25,824    30,287    26,646    23,500    105,522    110,556 
GAAP Gross margin (GAAP gross profit as % of revenue)   48.8%   53.7%   41.1%   37.1%   44.4%   55.8%
Non-GAAP gross margin (non-GAAP gross profit as % of revenue)   41.3%   47.2%   34.9%   29.1%   37.5%   49.6%
GAAP total operating expenses  $34,547   $36,157   $47,547   $33,670   $148,510   $120,314 
Shipping and handling costs (1)   (1,926)   (1,976)   (1,636)   (1,868)   (7,206)   (6,892)
Non-GAAP total operating costs  $32,621   $34,181   $45,911   $31,802   $141,304   $113,422 
GAAP loss from operations  $(21,955)  $(19,896)  $(36,603)  $(24,959)  $(101,704)  $(58,586)
Non-GAAP loss from operations  $(21,955)  $(19,896)  $(36,603)  $(24,959)  $(101,704)  $(58,586)


(1) Shipping and handling costs, which include freight and other activities costs associated with product shipments, net of charges passed on to the customer, are captured within operating expenses in our consolidated statements of operations. During the three months and year ended December 31, 2022, we incurred $1.9 million and $7.2 million, respectively, of shipping and handling costs recorded within operating expenses. During the three months and year ended December 31, 2021, we incurred $2.0 million and $6.9 million, respectively, of shipping and handling costs recorded within operating expenses. During the three months ended September 30, 2022, we incurred $1.6 million of shipping and handling costs within operating expenses. During the three months ended June 30, 2022, we incurred $2.1 million of shipping and handling costs within operating expenses.


About Quanterix


From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is driving breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa ® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,000 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.





Forward-Looking Statements


This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements about Quanterix’ financial performance, including anticipated progress associated with Quanterix’ strategic business alignment plan, and are subject to a number of risks, uncertainties and assumptions. Forward-looking statements in this news release are based on Quanterix’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’ actual results to differ from those expressed or implied in the forward-looking statements in this press release include, but are not limited to, those described in “Part I, Item 1A, “Risk Factors” in Quanterix’ Annual Report on Form 10-K for the year ended December 31, 2022, to be filed with the SEC on March 6, 2023. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.




PAN Communications
Maya Nimnicht


Investor Relations:
Amy Achorn
(978) 488-1854





Exhibit 99.2

1 Quanterix Corporation Supplemental Schedule of Operating Expenses (Unaudited and in thousands) Three Months Ended December 31 2022 2021 Operating expenses: Research and development $ 5,600 $ 7,734 Selling, general and administrative 19,272 28,423 Subtotal $ 24,872 $ 36,157 Other lease costs 669 — Restructuring 329 — Goodwill impairment — — Impairment expense 8,677 — Subtotal $ 9,675 $ — Total operating expenses $ 34,547 $ 36,157