Full Press Release Details
Reports Fourth Quarter and Full Year 2022 Financial Results
AUSTIN, Texas, February 28, 2023 /PRNewswire/ - Natera, Inc.
(NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported financial
results for the fourth quarter and year ended December 31, 2022 and provided an update on recent business progress and financial outlook.
Recent Accomplishments & Highlights
"We delivered another strong year in 2022,
helping a record number of patients with their care," said Steve Chapman, Natera's Chief Executive Officer. "We achieved
important milestones that demonstrate the clinical utility of our tests, expanded coverage, and built on our leadership in evidence generation.
Our guidance for 2023 reflects our expectations for robust top-line growth as we reduce operating expenses and continue to position the
company for ongoing success."
Fourth Quarter and Year Ended December 31, 2022 Financial Results
Total revenues were $217.3 million in the fourth quarter of 2022 compared
to $173.0 million for the fourth quarter of 2021, an increase of 25.6%. The increase in total revenues was driven primarily by a 28.2%
increase in product revenues, which were $212.9 million in the fourth quarter of 2022 compared to $166.1 million in the fourth quarter
of 2021. The increase in product revenues was driven by an increase in test volumes compared to the fourth quarter of 2021. Natera processed
approximately 559,700 tests in the fourth quarter of 2022, including approximately 543,900 tests accessioned in its laboratory, compared
to approximately 438,800 tests processed, including approximately 424,200 tests accessioned in its laboratory, in the fourth quarter of
In the fourth quarter of 2022, Natera recognized revenue on approximately
519,200 tests for which results were reported to customers in the period (tests reported), including approximately 504,500 tests reported
from its laboratory, compared to approximately 410,900 tests reported, including approximately 397,100 tests reported from its laboratory,
in the fourth quarter of 2021, an overall increase of 26.4% for the quarter.
Total revenues for 2022 were approximately $820.2
million compared to $625.5 million in 2021, which represents an increase of 31.1%. Total revenues, excluding non-recurring revenues of
$28.6 million from the Qiagen arrangement, increased by 37.4% in 2022 compared to 2021. In 2022, Natera processed approximately 2,066,500
tests including approximately 2,004,000 tests accessioned in its laboratory, compared to approximately 1,570,000 tests processed in 2021,
including approximately 1,513,400 tests accessioned in its laboratory.
In 2022, Natera recognized revenue on approximately
1,919,600 tests reported, including approximately 1,861,000 tests reported from its laboratory, compared to approximately 1,453,500 tests
reported, including approximately 1,400,100 tests reported from its laboratory, in 2021, an overall increase of 32.1% for the year.
Gross profit* for the three months ended December 31, 2022 and
2021 was $90.0 million and $78.9 million, respectively, representing a gross margin of 41.4% and 45.6%, respectively. Natera had
lower margins in the fourth quarter of 2022 compared to the fourth quarter 2021 primarily due to increased labor and overhead costs driven
by volume growth and customer support. Gross profit for the year ended December 31, 2022 and 2021 was $364.0 million and $307.1 million,
respectively, representing a gross margin of 44.4% and 49.1%, respectively. Natera had lower margins in the year 2022 primarily due to
changing product mix, increased labor and overhead costs driven by volume growth and customer support, as well as one time revenue recognized
from the Qiagen arrangement in 2021.
Total operating expenses, representing research
and development expenses and selling, general and administrative expenses, for the fourth quarter of 2022 were $231.7 million, compared
to $218.6 million in the same period of the prior year, an increase of 6.0%. Total operating expenses in the year ended December
31, 2022 were $905.0 million, an increase of approximately 16.7% compared to $775.2 million in the prior year. The increases were primarily
driven by headcount growth to support new product offerings.
Loss from operations for the fourth quarter of
2022 was $141.8 million compared to $139.7 million for the same period of the prior year. Loss from operations for
the year 2022 was $541.0 million compared to $468.2 million compared to the prior year.
Net loss for the fourth quarter of 2022 was $142.6
million, or ($1.37) per diluted share, compared to net loss of $140.6 million, or ($1.48) per diluted share, for the same period in 2021.
Weighted average shares outstanding were approximately 104.3 million in the fourth quarter of 2022 compared to 94.8 million in the fourth
quarter of the prior year. Net loss for the full year 2022 was $547.8 million, or ($5.57) per diluted share, compared to net loss of
$471.7 million, or ($5.21) per diluted share, for the full year 2021. Weighted average shares outstanding were 98.4 million in 2022 compared
to 90.6 million in 2021.
At December 31, 2022, Natera held approximately $898.4 million in cash,
cash equivalents, short-term investments and restricted cash, compared to $914.5 million as of December 31, 2021. As of December 31, 2022,
Natera had a total outstanding debt balance of $362.0 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 bps and a net carrying amount of $281.7 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 December 31, 2022.
Natera anticipates 2023 total revenue of $980 million to $1 billion;
2023 gross margin to be approximately 41% to 44% of revenues; selling, general and administrative costs to be approximately $510 million
to $540 million; research and development costs to be $325 million to $345 million, and net cash consumption to be $300 million to $325
* 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 between $250 million and $275 million) and GAAP net purchases of property and equipment
(estimated for 2023 to be approximately $50 million).
| Unit | Q4 2022 | Q4 2021 | FY 2022 | FY 2021 | Definition | |||||||||||||
| Tests processed | 559,700 | 438,800 | 2,066,500 | 1,570,000 | Tests accessioned in our laboratory plus units processed outside of our laboratory | |||||||||||||
| Tests accessioned | 543,900 | 424,200 | 2,004,000 | 1,513,400 | Test accessioned in our laboratory | |||||||||||||
| Tests reported in our laboratory | 504,500 | 397,100 | 1,861,000 | 1,400,100 | Total tests reported in our laboratory less units reported outside of our laboratory | |||||||||||||
| Tests reported | 519,200 | 410,900 | 1,919,600 | 1,453,500 | Total tests reported |
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 100 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 Fourth Quarter and Full Year 2022 Financial Results Conference Call |
| Date: | Tuesday, February 28, 2023 |
| Time: | 1:30 p.m. PT (4:30 p.m. ET) |
| Live Dial-In: | (888) 770-7321, Toll-Free |
| (929) 201-7107, International | |
| Conference ID: | 7684785 |
| Webcast Link: | https://events.q4inc.com/attendee / 196748198 |
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