Sixth Consecutive Quarter of Double-Digit
Growth
Reaffirms Full Year 2024 Outlook
Quanterix Corporation (NASDAQ: QTRX), a company fueling
scientific discovery through ultra-sensitive biomarker detection,
today announced preliminary financial results for the third quarter
ended September 30, 2024 and reaffirmed its full year 2024
guidance. The Company also disclosed the need to restate certain
prior period financial statements to correct non-cash errors
related to those periods.
“Quanterix continues to build on our strong momentum, achieving
our sixth consecutive quarter of double-digit growth. We are
pleased to reaffirm our full year 2024 outlook, which is especially
notable given the muted growth that continues to impact the tools
space,” said Masoud Toloue, Chief Executive Officer of Quanterix.
“With a focus on disciplined execution of our strategic priorities,
we are expanding the Quanterix portfolio of innovative products and
services, empowering our customers to break new ground in research,
and lead advancements in Alzheimer’s diagnostics.”
Preliminary Third Quarter 2024 Financial Highlights
- Revenue of $35.7 million, an increase of 13% compared to $31.6
million in the corresponding prior year period, as preliminarily
restated.
- GAAP gross margin of 58.9% and Non-GAAP gross margin of
53.4%.
- Net cash usage in the quarter was $3.3 million. The Company
ended the period with $296.1 million of cash, cash equivalents,
marketable securities, and restricted cash.
These preliminary financial results are based on current best
available information and are unaudited and subject to adjustment,
including in connection with the finalization of the restated
financial statements as further described below. The Company
expects to report its final results for the third quarter of 2024,
which could vary from the preliminary financial results disclosed
in this press release, in its Quarterly Report on Form 10-Q,
following the filing of the restated financial statements, as
further described below.
Third Quarter Operational and Business Highlights
- The Company announced the launch of LucentAD Complete, a
multi-marker test for Alzheimer’s Disease (AD) detection. The test
leverages a proprietary algorithm to generate an AD score by
analyzing five Alzheimer’s disease-related biomarkers (p-Tau 217,
Aβ42/40, NfL, GFAP), offering significantly improved amyloid
classification and reducing inconclusive results by up to
three-fold compared to traditional single-marker tests.
- In September 2024, Mt. Sinai Health System announced that they
would be deploying blood-based biomarkers as early detection tools
across primary and specialty care settings. Mt. Sinai will be
examining p-Tau 217, as well as NfL and GFAP using our assays
through a grant from the Davos Alzheimer’s Collaborative.
- The Company continues to advance its innovation rate and this
quarter released a new series of ultra-sensitive 4-marker panels in
neurology and immunology, as well as an extracellular vesicle
profiling tool kit, which has research applications in multiple
disease areas.
- The Company added two members to its Board of Directors, Jeff
Elliott, former CFO of Exact Sciences, and Ivana
Magovčević-Liebisch, Ph.D., J.D., President and CEO of Vigil
Neuroscience.
2024 Full Year Business Outlook
The Company reaffirms its 2024 revenue guidance range of $134
million to $138 million. This revenue range excludes revenue from
Lucent Diagnostics testing, which is expected to be immaterial for
2024. The Company also reaffirmed that it expects its research-use
only business (excluding Diagnostics) to achieve cash flow
breakeven when it reaches revenue between $170 and $190
million.
The Company continues to expect GAAP gross margin percentage to
be in the range of 57%-61%, and non-GAAP gross margin percentage to
be in the range of 51%-55%. The Company continues to anticipate
2024 cash usage (change in cash, cash equivalents, marketable
securities, and restricted cash) to be approximately $30
million.
For additional information on the preliminary non-GAAP financial
measures included in this press release, please see “Use of
Non-GAAP Financial Measures,” “Preliminary Restated Non-GAAP
Measures” and “Preliminary Restated GAAP to Non-GAAP
Reconciliation” below.
Restatement of Historical Financial Results
As previously reported, the Company has identified and continues
its efforts to remediate a material weakness in its internal
control over financial reporting relating to the operating
effectiveness of internal controls associated with the accounting
for inventory valuation.
In connection with these remediation efforts, and while
performing closing procedures for the third quarter 2024,
management identified an error related to the capitalization of
labor and overhead costs applied to prior periods, which impacted
the valuation of inventory. This error relates to a design
deficiency in the Company’s internal control over financial
reporting related to the accounting for inventory valuation. The
cumulative effect of this error, when taken together with unrelated
immaterial errors identified by the Company in prior periods,
resulted in the need for material adjustments to previously issued
financial statements.
The Audit Committee of the Board of Directors and management
therefore concluded that it is appropriate to restate the Company’s
audited consolidated financial statements as of December 31, 2023
and 2022 and for each of the three years in the period ended
December 31, 2023, and its unaudited consolidated financial
statements for the quarterly and year-to-date (as applicable)
periods ended March 31, 2022, June 30, 2022, September 30, 2022,
March 31, 2023, June 30, 2023, September 30, 2023, March 31, 2024
and June 30, 2024 (the “Restatement”) in order to correct all known
errors in accounting in the financial statements for such periods.
The Company intends, as promptly as possible, to complete the
Restatement and to file with the Securities and Exchange Commission
amendments to the Company’s Annual Report on Form 10-K for the year
ended December 31, 2023, and its Quarterly Reports on Form 10-Q for
the first and second quarters of 2024 and to file its Quarterly
Report on Form 10-Q for the third quarter of 2024. Although there
can be no assurance, the Company’s goal is to complete the
Restatement and all required filings by the end of 2024.
The Company currently estimates that the corrections to be made
as part of the Restatement will result in the following impact to
gross profit and operating loss:
GAAP Gross Profit
Increase
Operating Loss
Increase/(Decrease)
Year ended December 31, 2021
$1.6 million
$(0.6) million
Year ended December 31, 2022
$0.4 million
$0.5 million
Year ended December 31, 2023
$2.1 million
$(2.3) million
These preliminary figures are based on currently available
information and are unaudited and subject to adjustment. The
supplemental schedules in this press release provide additional
information regarding the preliminary anticipated impact of the
Restatement, but such additional information is also based on
currently available information and is unaudited and subject to
adjustment. The Company does not expect the errors to result in any
material impact on the previously reported amounts for total
revenues or cash in any completed fiscal period.
The Company expects to delay the filing of its Quarterly Report
on Form 10-Q for the third quarter of 2024, in order to complete
the Restatement and will file a Form 12b-25 with the Securities and
Exchange Commission. Additional information regarding the
Restatement and the preliminary anticipated effect of the
Restatement on the Company’s previously reported financial
information is included in the Company’s Current Report on Form 8-K
(and exhibits) filed on November 12, 2024.
Conference Call
In conjunction with this announcement, the Company will host a
conference call on November 12, 2024, at 4:30 PM E.T. Click here to
register for the conference call with a webcast link. For audio use
the following dial-in number and passcode: USA & Canada –
Toll-Free (800) 715-9871 Conference ID: 2720617.
Interested investors can also listen to the live webcast from
the Event Details page in the Investors section of the Quanterix at
https://ir.quanterix.com. An archived webcast replay will be
available on the Company’s website for one year.
Supplemental Schedules
Preliminary Restated GAAP Financials
FY21
FY22
Q1FY23
Q2FY23
Q3FY23
Q4FY23
FY23
Q1FY24
Q2FY24
Q3FY24
As Reported
Revenue
110.6
105.5
28.5
31.0
31.3
31.5
122.4
32.1
34.4
35.7
Gross Profit $
61.7
46.8
16.9
19.1
17.8
16.8
70.6
19.6
20.1
21.1
Gross Profit %
55.8%
44.4%
59.5%
61.7%
56.8%
53.2%
57.7%
61.2%
58.3%
58.9%
Operating Expense
120.3
148.5
26.3
28.7
31.6
33.8
120.3
33.6
33.2
32.3
Operating Loss
(58.6)
(101.7)
(9.4)
(9.6)
(13.8)
(17.0)
(49.7)
(14.0)
(13.1)
(11.2)
GAAP Adjustments
Revenue
0.0
0.0
0.0
(0.2)
0.2
0.0
0.0
0.0
0.1
0.0
Gross Profit $
1.6
0.4
(0.9)
0.4
1.1
1.5
2.1
(0.8)
1.5
0.0
Operating Expense
1.0
0.9
0.2
(0.5)
0.7
(0.7)
(0.3)
0.0
(0.1)
0.0
Operating Loss
0.6
(0.5)
(1.1)
0.9
0.5
2.2
2.3
(0.8)
1.6
0.0
Restated
Revenue
110.6
105.5
28.5
30.8
31.6
31.5
122.4
32.1
34.4
35.7
Gross Profit $
63.3
47.2
16.0
19.5
18.9
18.3
72.7
18.8
21.6
21.1
Gross Profit %
57.3%
44.7%
56.3%
63.4%
59.9%
57.8%
59.4%
58.7%
62.7%
58.9%
Operating Expense
121.3
149.4
26.6
28.2
32.2
33.1
120.1
33.6
33.1
32.3
Operating Loss
(58.0)
(102.2)
(10.6)
(8.7)
(13.3)
(14.8)
(47.4)
(14.8)
(11.5)
(11.2)
Use of Non-GAAP Financial Measures
To supplement the preliminary restated financial statements
presented on a U.S. GAAP basis, the Company also presents
preliminary restated non-GAAP gross profit, non-GAAP gross margin,
non-GAAP total operating expenses, and non-GAAP loss from
operations. These non-GAAP measures are calculated by including
shipping and handling costs for product sales within cost of
product revenue instead of within selling, general, and
administrative expenses. The Company uses these non-GAAP measures
to evaluate its operating performance in a manner that allows for
meaningful period-to-period comparison and analysis of trends in
its business and its competitors. The Company believes that
presentation of these non-GAAP measures provides useful information
to investors in assessing the Company’s operating performance
within its industry and 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. 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 U.S. GAAP.
Set forth below is the preliminary restated non-GAAP gross
profit, non-GAAP gross margin, non-GAAP total operating expenses,
and non-GAAP loss from operations and a reconciliation of these
preliminary restated non-GAAP measures to their most directly
comparable preliminary restated GAAP financial measures.
Preliminary Restated Non-GAAP Measures
FY21
FY22
Q1FY23
Q2FY23
Q3FY23
Q4FY23
FY23
Q1FY24
Q2FY24
Q3FY24
As Reported (Non-GAAP)
Revenue
110.6
105.5
28.5
31.0
31.3
31.5
122.4
32.1
34.4
35.7
Gross Profit $
54.8
39.6
15.1
17.5
15.2
14.7
62.5
17.5
18.0
19.1
Gross Profit %
49.6%
37.5%
53.1%
56.4%
48.6%
46.5%
51.1%
54.5%
52.3%
53.4%
Operating Expense
113.4
141.3
24.5
27.1
29.0
31.7
112.2
31.5
31.1
30.3
Operating Loss
(58.6)
(101.7)
(9.4)
(9.6)
(13.8)
(17.0)
(49.7)
(14.0)
(13.1)
(11.2)
Adjustments
Revenue
0.0
0.0
0.0
(0.2)
0.2
0.0
0.0
0.0
0.1
0.0
Gross Profit $
0.6
(0.3)
(0.9)
0.4
1.1
1.5
2.1
(0.8)
1.5
0.0
Operating Expense
0.0
0.2
0.2
(0.5)
0.7
(0.7)
(0.3)
0.0
(0.1)
0.0
Operating Loss
0.6
(0.5)
(1.1)
0.9
0.5
2.2
2.3
(0.8)
1.6
0.0
Restated (Non-GAAP)
Revenue
110.6
105.5
28.5
30.8
31.6
31.5
122.4
32.1
34.4
35.7
Gross Profit $
55.4
39.3
14.2
17.9
16.3
16.2
64.6
16.7
19.5
19.1
Gross Profit %
50.1%
37.2%
49.9%
58.2%
51.8%
51.1%
52.8%
52.0%
56.7%
53.4%
Operating Expense
113.4
141.5
24.8
26.6
29.6
31.0
112.0
31.5
31.0
30.3
Operating Loss
(58.0)
(102.2)
(10.6)
(8.7)
(13.3)
(14.8)
(47.4)
(14.8)
(11.5)
(11.2)
Preliminary Restated GAAP to Non-GAAP Reconciliation
FY21
FY22
Q1FY23
Q2FY23
Q3FY23
Q4FY23
FY23
Q1FY24
Q2FY24
Q3FY24
Preliminary Restated GAAP gross profit
63.3
47.2
16.0
19.5
18.9
18.3
72.7
18.8
21.6
21.1
Shipping and handling costs
(7.9)
(7.9)
(1.8)
(1.6)
(2.6)
(2.1)
(8.1)
(2.1)
(2.1)
(2.0)
Preliminary Restated Non-GAAP gross
profit
55.4
39.3
14.2
17.9
16.3
16.2
64.6
16.7
19.5
19.1
GAAP Revenue
110.6
105.5
28.5
30.8
31.6
31.5
122.4
32.1
34.4
35.7
Gross margin (gross profit as a % of GAAP
revenue)
57.3%
44.7%
56.3%
63.4%
59.9%
57.8%
59.4%
58.7%
62.7%
58.9%
Non-GAAP gross margin (non-GAAP gross
profit as a % of GAAP revenue)
50.1%
37.2%
49.9%
58.2%
51.8%
51.1%
52.8%
52.0%
56.7%
53.4%
Preliminary Restated GAAP total operating
expenses
121.3
149.4
26.6
28.2
32.2
33.1
120.1
33.6
33.1
32.3
Shipping and handling costs
(7.9)
(7.9)
(1.8)
(1.6)
(2.6)
(2.1)
(8.1)
(2.1)
(2.1)
(2.0)
Preliminary Restated Non-GAAP total
operating costs
113.4
141.5
24.8
26.6
29.6
31.0
112.0
31.5
31.0
30.3
Preliminary Restated GAAP loss from
operations
(58.0)
(102.2)
(10.6)
(8.7)
(13.3)
(14.8)
(47.4)
(14.8)
(11.5)
(11.2)
Preliminary Restated Non-GAAP loss from
operations
(58.0)
(102.2)
(10.6)
(8.7)
(13.3)
(14.8)
(47.4)
(14.8)
(11.5)
(11.2)
About Quanterix
From discovery to diagnostics, Quanterix’s ultra-sensitive
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 of conventional analog methods. 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 3,100
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
Quanterix’s current financial results, as discussed in this
press release, are preliminary and unaudited, and subject to
adjustment. 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’s financial performance,
including statements under the headers “Preliminary Third Quarter
2024 Financial Highlights,” “2024 Full Year Business Outlook,”
“Restatement of Historical Financial Results” and “Supplemental
Schedules” set forth above, and are subject to a number of risks,
uncertainties and assumptions. Forward-looking statements in this
press release are based on Quanterix’s 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’s actual results to differ from those expressed or
implied in the forward-looking statements in this press release
include, but are not limited to, that the Company may have
underestimated the scope and impact of the Restatement, risks and
uncertainties around the effectiveness of the Company’s internal
control over financial reporting, the risk that the Company’s
restated financial statements may take longer to complete than
expected, as well as those described in our periodic reports filed
with the U.S. Securities and Exchange Commission, including the
“Risk Factors” sections contained therein. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241112640948/en/
Media Contact: media@quanterix.com Investor Relations
Contact: Amy Achorn (978) 488-1854 ir@quanterix.com
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