Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today reported financial results for the third quarter
ended September 30, 2023.
Recent Strategic and Financial Highlights
- Generated total revenues of $268.3 million in the third quarter
of 2023, compared to $210.6 million in the third quarter of 2022,
an increase of approximately 27%. Product revenues grew
approximately 33% over the same period.
- Delivered gross margin of 45.1% in the third quarter of 2023,
compared to 44.7% in the third quarter of 2022.
- Reduced cash burn to approximately $38 million in the third
quarter of 2023, a decrease of approximately 66% compared to the
third quarter of 2022.
- Processed approximately 626,000 tests in the third quarter of
2023, compared to approximately 517,500 tests in the third quarter
of 2022, an increase of approximately 21%.
- Performed approximately 89,000 oncology tests in the third
quarter of 2023, compared to approximately 53,000 in the third
quarter of 2022, an increase of approximately 68%. This includes
approximately 81,000 Signatera™ clinical units in the third quarter
of 2023, an increase of 85% compared to the prior year period and
one of Natera’s best quarters on record in terms of absolute unit
growth for Signatera in the clinical channel.
- Raised 2023 annual guidance for revenue to a new range of
$1.035 billion to $1.05 billion and gross margin to a range of 43%
to 44%; significantly reduced cash burn guidance for 2023, lowering
the range to $260 million to $280 million.
- Published results from RenaCARE study, demonstrating
significant diagnostic and clinical utility of Renasight™ test in
chronic kidney disease.
- Presented large, updated analysis on GALAXY arm of
CIRCULATE-Japan reinforcing prognostic and predictive value of
Signatera in colorectal cancer; published or presented additional
key data on Signatera across multiple indications.
- Announced randomized, phase III trial in early-stage breast
cancer, adding to pipeline of clinical trials related to treatment
on molecular relapse.
- Announced broad clinical launch and Medicare coverage of
FoundationOne®Tracker, in partnership with Foundation
Medicine.
“We delivered robust volume and revenue growth in the third
quarter, while demonstrating operational discipline with a
significant reduction in cash burn,” said Steve Chapman, chief
executive officer of Natera. “We continued to deliver on our
strategic clinical roadmap with the publication of the landmark
RenaCARE study in chronic kidney disease and key Signatera evidence
across multiple cancer indications. As reflected in our revised
guidance for the remainder of the year, we’ve increased our revenue
target while reducing our cash burn goal, so we are well-positioned
to help more patients than ever before.”
Third Quarter Ended September 30, 2023 Financial
Results
Total revenues were $268.3 million in the third quarter of 2023,
compared to $210.6 million for the third quarter of 2022, an
increase of 27.4%. Product revenues were $265.2 million in the
third quarter of 2023, compared to $199.8 million in the third
quarter of 2022, an increase of 32.7%. Growth in product revenues
was mainly driven by an increase in test volumes as well as average
selling price improvements.
Natera processed approximately 626,000 tests in the third
quarter of 2023, including approximately 609,800 tests accessioned
in its laboratory. This compares to approximately 517,500 tests
processed in the third quarter of 2022, including approximately
502,900 tests accessioned in its laboratory, an increase of
21.0%.
In the three months ended September 30, 2023, Natera recognized
revenue on approximately 590,000 tests for which results were
reported to customers in the period (tests reported), including
approximately 575,000 tests reported from its laboratory, compared
to approximately 482,900 tests reported, including approximately
469,200 tests reported from its laboratory, in the third quarter of
2022, an increase of 22.2% for the quarter.
Gross profit* for the three months ended September 30, 2023 and
September 30, 2022 was $121.0 million and $94.1 million,
respectively, representing a gross margin of 45.1% and 44.7%.
Natera had higher gross margin in the third quarter of 2023
compared to the third quarter of 2022 primarily as a result of
increased revenues and continuous reductions in cost of goods sold
associated with tests processed.
Total operating expenses, representing research and development
expenses and selling, general and administrative expenses, were
$232.0 million for the third quarter of 2023, compared to $213.2
million in the same period of the prior year, an increase of 8.8%.
The increase was primarily driven by an increase in payroll and
payroll-related expenses as well as a one-time benefit for a
research and development expense related to earnout milestone
payments in the third quarter of 2022. Loss from operations for the
third quarter of 2023 was $111.0 million, compared to $119.1
million for the same period of the prior year.
The Company reported a net loss of $109.0 million, or ($0.95)
per diluted share, for the third quarter of 2023, compared to a net
loss of $121.5 million, or ($1.25) per diluted share, for the same
period in 2022. Weighted average shares outstanding were
approximately 115.2 million in the third quarter of 2023, compared
to 97.1 million in the third quarter of the prior year.
As of September 30, 2023, Natera held approximately $936.6
million in cash, cash equivalents, short-term investments and
restricted cash, compared to $898.4 million as of December 31,
2022. As of September 30, 2023, Natera had a total outstanding debt
balance of $363.0 million, comprised of $80.4 million including
accrued interest under its line of credit with UBS at a variable
interest rate of 30-day SOFR plus 121 basis points and a net
carrying amount of $282.6 million under its seven-year convertible
senior notes issued in April 2020. The gross principal balance
outstanding for the convertible senior notes was $287.5 million as
of September 30, 2023. In October 2023, the interest rate for the
Credit Line was subsequently changed to the 30-day SOFR average,
plus 50 basis points.
Financial Outlook
Natera is revising its 2023 annual guidance. The Company now
expects annual revenue to be in a range of $1.035 billion to $1.05
billion, up from its previous range of $1.015 billion to $1.035
billion; and gross margin to be in a range of approximately 43% to
44% of revenues, revised from its previous range of 41% to 44%. The
Company continues to expect selling, general and administrative
costs to be approximately $540 million to $580 million, and
research and development costs to be approximately $325 million to
$345 million. In addition, net cash consumption is now expected to
be approximately $260 million to $280 million, down from its
previous range of $300 million to $325 million**.
* Gross profit is calculated as GAAP total revenues less GAAP
cost of revenues. Gross margin is calculated as gross profit
divided by GAAP total revenues.
** Cash consumption is calculated as the sum of GAAP net cash
used by operating activities (estimated for 2023 to be
approximately $210 million to $230 million) and GAAP net purchases
of property and equipment (estimated for 2023 to be approximately
$50 million).
Test Volume Summary
Unit
Q3 2023
Q3 2022
Definition
Tests processed
626,000
517,500
Tests accessioned in our laboratory plus
units processed outside of our laboratory
Tests accessioned
609,800
502,900
Test accessioned in our laboratory
Tests reported in our laboratory
575,000
469,200
Total tests reported in our laboratory
less units reported outside of our laboratory
Tests reported
590,000
482,900
Total tests reported
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated
to oncology, women’s health, and organ health. We aim to make
personalized genetic testing and diagnostics part of the standard
of care to protect health and enable earlier, more targeted
interventions that help lead to longer, healthier lives. Natera’s
tests are validated by more than 150 peer-reviewed publications
that demonstrate high accuracy. Natera operates ISO 13485-certified
and CAP-accredited laboratories certified under the Clinical
Laboratory Improvement Amendments (CLIA) in Austin, Texas and San
Carlos, California. For more information, visit www.natera.com.
Conference Call Information
Event:
Natera's Third Quarter 2023
Financial Results Conference Call
Date:
Wednesday, November 8, 2023
Time:
1:30 p.m. PT (4:30 p.m. ET)
Live Dial-In:
(888) 770-7321, Domestic
(929) 201-7107, International
Conference ID:
7684785
Webcast Link:
https://events.q4inc.com/attendee/156437855
Forward-Looking Statements
This press release contains forward-looking statements under the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements other than statements of historical facts, including
the company’s financial guidance for fiscal 2022, its ability to
continue to increase its revenues, its product development plans
and its ability to maintain and grow its business operations in
light of the COVID-19 pandemic, are forward-looking statements. Any
forward-looking statements contained in this press release are
based upon Natera’s current plans, estimates, and expectations, as
of the date of this release, and are not a representation that such
plans, estimates, or expectations will be achieved.
These forward-looking statements are subject to known and
unknown risks and uncertainties that may cause actual results to
differ materially, including: we face numerous uncertainties and
challenges in achieving our financial projections and goals; we may
be unable to further increase the use and adoption of our products
through our direct sales efforts or through our laboratory
partners; we have incurred losses since our inception and we
anticipate that we will continue to incur losses for the
foreseeable future; our quarterly results may fluctuate from period
to period; our estimates of market opportunity and forecasts of
market growth may prove to be inaccurate; we may be unable to
compete successfully with existing or future products or services
offered by our competitors; we may engage in acquisitions,
dispositions or other strategic transactions that may not achieve
our anticipated benefits and could otherwise disrupt our business,
cause dilution to our stockholders or reduce our financial
resources; we may need to raise additional capital to support our
business plans, which may not be available when necessary or on
favorable terms; we may not be successful in commercializing our
cloud-based distribution model; our products may not perform as
expected; the results of our clinical studies, including our
SNP-based Microdeletion and Aneuploidy RegisTry, or SMART, Study,
may not be compelling to professional societies or payors as
supporting the use of our tests, particularly for microdeletions
screening, or may not be able to be replicated in later studies
required for regulatory approvals or clearances; if either of our
primary CLIA-certified laboratories becomes inoperable, we will be
unable to perform our tests and our business will be harmed; we
rely on a limited number of suppliers or, in some cases, single
suppliers, for some of our laboratory instruments and materials and
may not be able to find replacements or immediately transition to
alternative suppliers; if we are unable to successfully scale our
operations, our business could suffer; the marketing, sale, and use
of Panorama and our other products could result in substantial
damages arising from product liability or professional liability
claims that exceed our resources; we may be unable to expand,
obtain or maintain third-party payer coverage and reimbursement for
Panorama, Horizon and our other tests, and we may be required to
refund reimbursements already received; third-party payers may
withdraw coverage or provide lower levels of reimbursement due to
changing policies, billing complexities or other factors; if the
FDA were to begin actively regulating our tests, we could incur
substantial costs and delays associated with trying to obtain
premarket clearance or approval and incur costs associated with
complying with post-market controls; litigation or other
proceedings, including investigations, subpoenas, demands,
disputes, litigation, requests for information and other regulatory
or administrative actions or proceedings, or resulting from either
third party claims of intellectual property infringement or
asserting infringement by third parties of our technology, is
costly, may result in substantial business and financial penalties,
may be time-consuming and could limit our ability to commercialize
our products or services; any inability to effectively protect our
proprietary technology could harm our competitive position or our
brand; and we cannot guarantee that we will be able to service and
comply with our outstanding debt obligations or achieve our
expectations regarding the conversion of our outstanding
convertible notes.
Additional risks and uncertainties that could affect our
financial results are included under the captions, "Risk Factors"
and "Management’s Discussion and Analysis of Financial Condition
and Results of Operations" in our most recent filings on Forms 10-K
and 10-Q and in other filings that we make with the SEC from time
to time. These documents are available on our website at
www.natera.com under the Investor Relations section and on the
SEC’s website at www.sec.gov.
In light of the significant uncertainties in these
forward-looking statements, you should not regard these statements
as a representation or warranty by us or any other person that we
will achieve our objectives and plans in any specified time frame,
or at all. Natera assumes no obligation to, and does not currently
intend to, update any such forward-looking statements after the
date of this release.
Natera, Inc.
Consolidated Balance
Sheets
(Unaudited)
(in thousands, except par
value per share amount)
September 30,
December 31,
2023
2022
(1)
Assets
Current assets:
Cash, cash equivalents and restricted
cash
$
668,710
$
466,091
Short-term investments
267,847
432,301
Accounts receivable, net of allowance of
$6,034 and $3,830 at September 30, 2023 and December 31, 2022,
respectively
255,147
244,385
Inventory
42,076
35,406
Prepaid expenses and other current assets,
net
33,496
33,634
Total current assets
1,267,276
1,211,817
Property and equipment, net
104,830
92,453
Operating lease right-of-use assets
58,206
71,874
Other assets
16,208
18,330
Total assets
$
1,446,520
$
1,394,474
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
21,321
$
31,148
Accrued compensation
39,415
44,010
Other accrued liabilities
133,740
144,214
Deferred revenue, current portion
15,012
10,777
Short-term debt financing
80,435
80,350
Total current liabilities
289,923
310,499
Long-term debt financing
282,619
281,653
Deferred revenue, long-term portion
21,033
20,001
Operating lease liabilities, long-term
portion
68,287
76,577
Total liabilities
661,862
688,730
Commitments and contingencies
Stockholders’ equity:
Common stock (2)
11
11
Additional paid-in capital
3,089,448
2,664,730
Accumulated deficit
(2,299,405
)
(1,942,635
)
Accumulated other comprehensive loss
(5,396
)
(16,362
)
Total stockholders’ equity
784,658
705,744
Total liabilities and stockholders’
equity
$
1,446,520
$
1,394,474
(1)
The consolidated balance sheet at December
31, 2022 has been derived from the audited consolidated financial
statements at that date included in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2022.
(2)
As of September 30, 2023 and December 31,
2022, there were approximately 118,990 and 111,255 shares of common
stock issued and outstanding, respectively.
Natera, Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per
share data)
Three months ended
Nine months ended
September 30,
September 30,
2023
2022
2023
2022
Revenues
Product revenues
$
265,218
$
199,831
$
761,271
$
584,415
Licensing and other revenues
3,088
10,806
10,195
18,555
Total revenues
268,306
210,637
771,466
602,970
Cost and expenses
Cost of product revenues
146,962
115,436
437,524
326,862
Cost of licensing and other revenues
349
1,076
1,060
2,102
Research and development
77,235
65,510
237,714
228,504
Selling, general and administrative
154,742
147,667
456,877
444,769
Total cost and expenses
379,288
329,689
1,133,175
1,002,237
Loss from operations
(110,982
)
(119,052
)
(361,709
)
(399,267
)
Interest expense
(3,252
)
(2,330
)
(9,490
)
(6,567
)
Interest and other income, net
5,406
87
14,509
1,165
Loss before income taxes
(108,828
)
(121,295
)
(356,690
)
(404,669
)
Income tax benefit (expense)
(202
)
(185
)
(80
)
(557
)
Net loss
$
(109,030
)
$
(121,480
)
$
(356,770
)
$
(405,226
)
Unrealized gain (loss) on
available-for-sale securities, net of tax
3,807
(3,212
)
10,966
(17,322
)
Comprehensive loss
$
(105,223
)
$
(124,692
)
$
(345,804
)
$
(422,548
)
Net loss per share
Basic and diluted
$
(0.95
)
$
(1.25
)
$
(3.14
)
$
(4.20
)
Weighted-average number of shares used in
computing basic and diluted net loss per share:
Basic and diluted
115,171
97,052
113,559
96,408
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231108253620/en/
Natera, Inc.
Investor Relations Mike Brophy,
CFO, Natera, Inc., 510-826-2350
Media Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
Natera (NASDAQ:NTRA)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Natera (NASDAQ:NTRA)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024