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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 8, 2024
Natera, Inc.
(Exact name of registrant as specified
in its charter)
Delaware |
|
001-37478 |
|
01-0894487 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
13011 McCallen Pass
Building A Suite 100
Austin, TX 78753
(Address of principal executive offices,
including zip code)
(650)
980-9190
(Registrant’s telephone number,
including area code)
N/A
(Former name or
former address, if changed since last report)
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 registered |
Common Stock, par value $0.0001 per share |
|
NTRA |
|
Nasdaq Stock Market LLC
(Nasdaq Global Select Market) |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 August 8, 2024, Natera, Inc. issued a press release announcing
the results for its second quarter ended June 30, 2024 and provided a related investor presentation. A copy of the press release
and a copy of the investor presentation are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current
Report on Form 8-K and are incorporated herein by reference.
The information in this Current Report on Form 8-K and the accompanying
Exhibit 99.1 and Exhibit 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (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, as amended, or the Exchange Act, regardless of any general incorporation
language in such filing, unless expressly incorporated by reference in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
|
Natera, Inc. |
|
|
|
|
By: |
/s/ Michael Brophy |
|
|
Michael Brophy |
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
Dated: August 8, 2024
Exhibit 99.1
Natera Reports Second Quarter 2024 Financial Results
AUSTIN, Texas, August 8, 2024 /PRNewswire/ — Natera, Inc.
(NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported
its financial results for the second quarter ended June 30, 2024.
Recent Strategic and Financial Highlights
|
· |
Generated
total revenues of $413.4 million in the second quarter of 2024, compared to $261.4 million in the second quarter of 2023, an increase
of 58.1%. Product revenues grew 59.3% over the same period. |
|
· |
Generated
a gross margin of 58.8% in the second quarter of 2024, compared to a gross margin of 45.2% in the second quarter of 2023. |
|
· |
Processed
approximately 760,300 tests in the second quarter of 2024, compared to approximately 617,200 tests in the second quarter of 2023,
an increase of 23.2%. |
|
· |
Performed
approximately 125,400 oncology tests in the second quarter of 2024, compared to approximately 83,500 in the second quarter of 2023,
an increase of 50.2%. |
|
· |
Achieved
positive cash flow of approximately $3.3 million1 in the second quarter of 2024. |
|
· |
Launched
a new feature for ProsperaTM Heart, enhancing detection of rejection in heart transplant patients. |
|
· |
Published
several peer-reviewed papers on SignateraTM in top journals. |
|
· |
Presented
new data at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting across a variety of indications, including breast
cancer, colorectal cancer, lung cancer, melanoma, esophageal cancer, and urothelial cancer. |
“Our second quarter financial results exceeded
our expectations with incredibly strong performance in volume, revenue and gross margin,” said Steve Chapman, chief executive officer
of Natera. “We look forward to continuing this positive momentum in the second half of 2024 and supporting our patients with cutting-edge
science, an innovative product portfolio, and excellent service that is core to our mission.”
Second Quarter Ended June 30, 2024 Financial
Results
Total revenues were $413.4 million in the second
quarter of 2024 compared to $261.4 million in the second quarter of 2023, an increase of 58.1%. The increase in total revenues was driven
primarily by a 59.3% increase in product revenues, which were $411.4 million in the second quarter of 2024 compared to $258.3 million
in the second quarter of 2023. The increase in product revenues was primarily driven by an increase in volume, average selling price
improvements, as well as cash receipts during the quarter related to tests delivered in prior periods that were fully collected.
Natera processed approximately 760,300 tests
in the second quarter of 2024, including approximately 744,000 tests accessioned in its laboratory, compared to approximately 617,200
tests processed, including approximately 599,000 tests accessioned in its laboratory, in the second quarter of 2023.
In the second quarter of 2024, Natera recognized
revenue on approximately 725,200 tests for which results were reported to customers in the period (tests reported), including approximately
709,800 tests reported from its laboratory, compared to approximately 594,900 tests reported, including approximately 578,200 tests reported
from its laboratory, in the second quarter of 2023, an increase of 21.9% from the prior period.
Gross profit2 for the three months
ended June 30, 2024 and 2023 was $243.2 million and $118.3 million, respectively, representing a gross margin of 58.8% and 45.2%,
respectively. Natera had higher gross margin in the second quarter of 2024 primarily as a result of higher revenues, continuous progress
in reducing cost of goods sold associated with tests processed, as well as incremental cash receipts during the quarter associated with
tests delivered in prior periods that were fully collected. Total operating expenses, representing research and development expenses
and selling, general and administrative expenses, for the second quarter of 2024 were $287.1 million, compared to $230.7 million in the
same period of the prior year, an increase of 24.4%. The increase was primarily driven by headcount growth to support new product offerings
as well as increases in consulting and legal expenses.
Loss from operations for the second quarter of
2024 was $43.9 million compared to $112.4 million for the same period of the prior year.
Natera reported a net loss for the second quarter
of 2024 of $37.5 million, or ($0.30) per diluted share, compared to a net loss of $110.8 million, or ($0.97) per diluted share, for the
same period in 2023. Weighted average shares outstanding were approximately 122.9 million in the second quarter of 2024 compared to 113.7
million in the second quarter of the prior year.
At June 30, 2024, Natera held approximately
$887.1 million in cash, cash equivalents, short-term investments and restricted cash, compared to $879.0 million as of December 31,
2023. As of June 30, 2024, Natera had a total outstanding debt balance of $364.0 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 50 bps and a net carrying amount of $283.6
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 June 30, 2024.
Financial Outlook
Natera anticipates 2024 total revenue of $1.49
billion to $1.52 billion; 2024 gross margin to be approximately 54% to 56% of revenues; selling, general and administrative costs to
be approximately $700 million to $750 million; research and development costs to be $350 million to $375 million; and net cash (outflow)
inflow to be ($25) million to $25 million3.
Test Volume
Summary |
Unit |
|
Q2
2024 |
|
|
Q2
2023 |
|
|
Definition |
Tests processed |
|
|
760,300 |
|
|
|
617,200 |
|
|
Tests accessioned
in our laboratory plus units processed outside of our laboratory |
Tests accessioned |
|
|
744,000 |
|
|
|
599,000 |
|
|
Test accessioned in our
laboratory |
Tests reported |
|
|
725,200 |
|
|
|
594,900 |
|
|
Total tests reported |
Tests reported in our laboratory |
|
|
709,800 |
|
|
|
578,200 |
|
|
Total tests reported in
our laboratory less units reported outside of our laboratory |
About Natera
Natera™
is a global leader in cell-free DNA and genetic 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 200 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 Second Quarter
2024 Financial Results Conference Call |
Date: |
Thursday, August 8, 2024 |
Time: |
1:30 p.m. PT (4:30 p.m. ET) |
Live Dial-In: |
1-888-596-4144 (Domestic) |
|
1-646-968-2525 (International) |
Conference ID: |
7684785 |
Webcast Link: |
https://events.q4inc.com/attendee/455235752 |
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 2024, its market opportunity, anticipated products and launch schedules,
reimbursement coverage and product costs, commercial and strategic partnerships and acquisitions, user experience, clinical trials and
studies, and its strategies, goals and general business and market conditions, 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 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 our 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; 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, if and when the FDA begins actively regulating our tests pursuant to recently enacted FDA regulations; litigation or other
proceedings, resulting from either third party claims of intellectual property infringement or third party infringement of our technology,
is costly, 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.
References
|
1. |
Positive cash flow for
the quarter ended June 30, 2024, is derived from the GAAP Statement of Cash Flows as follows: net cash provided by operating
activities of $4.0 million, net cash provided by financing activities of $11.0 million, offset by net cash used in investing activities
for purchases of property and equipment and acquisition of an asset of $11.7 million. |
|
2. |
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. |
|
3. |
Cash (outflow) inflow is
calculated as the sum of GAAP net cash provided by (used in) operating activities, GAAP net cash provided by (used in) financing
activities, and GAAP net cash provided by (used in) investing activities for purchases of property and equipment and acquisition
of assets. |
Contacts
Investor Relations
Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media
Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Natera, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except shares)
| |
| June 30, | | |
| December 31, | |
| |
| 2024 | | |
| 2023
(1) | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash, cash equivalents and restricted cash | |
$ | 796,798 | | |
$ | 642,095 | |
Short-term investments | |
| 90,299 | | |
| 236,882 | |
Accounts receivable, net of allowance of $7,021 and $6,481 at
June 30, 2024 and December 31, 2023, respectively | |
| 335,936 | | |
| 278,289 | |
Inventory | |
| 40,985 | | |
| 40,759 | |
Prepaid expenses and other current assets,
net | |
| 37,798 | | |
| 60,524 | |
Total current assets | |
| 1,301,816 | | |
| 1,258,549 | |
Property and equipment, net | |
| 133,280 | | |
| 111,210 | |
Operating lease right-of-use assets | |
| 52,582 | | |
| 56,537 | |
Other assets | |
| 29,311 | | |
| 15,403 | |
Total assets | |
$ | 1,516,989 | | |
$ | 1,441,699 | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 33,100 | | |
$ | 14,998 | |
Accrued compensation | |
| 41,487 | | |
| 45,857 | |
Other accrued liabilities | |
| 141,231 | | |
| 149,405 | |
Deferred revenue, current portion | |
| 18,367 | | |
| 16,612 | |
Short-term debt financing | |
| 80,389 | | |
| 80,402 | |
Total current liabilities | |
| 314,574 | | |
| 307,274 | |
Long-term debt financing | |
| 283,604 | | |
| 282,945 | |
Deferred revenue, long-term portion and other liabilities | |
| 21,066 | | |
| 19,128 | |
Operating lease liabilities, long-term portion | |
| 61,225 | | |
| 67,025 | |
Total liabilities | |
| 680,469 | | |
| 676,372 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock (2) | |
| 12 | | |
| 11 | |
Additional paid-in capital | |
| 3,320,365 | | |
| 3,145,837 | |
Accumulated deficit | |
| (2,482,499 | ) | |
| (2,377,436 | ) |
Accumulated other comprehensive loss | |
| (1,358 | ) | |
| (3,085 | ) |
Total stockholders’ equity | |
| 836,520 | | |
| 765,327 | |
Total liabilities and stockholders’ equity | |
$ | 1,516,989 | | |
$ | 1,441,699 | |
|
(1) |
The consolidated balance
sheet at December 31, 2023 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, 2023. |
|
(2) |
As of June 30, 2024
and December 31, 2023, there were approximately 123,365,000 and 119,581,000 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 | | |
Six months ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues | |
| | | |
| | | |
| | | |
| | |
Product revenues | |
$ | 411,364 | | |
$ | 258,256 | | |
$ | 776,036 | | |
$ | 496,053 | |
Licensing and other
revenues | |
| 1,987 | | |
| 3,148 | | |
| 5,056 | | |
| 7,107 | |
Total revenues | |
| 413,351 | | |
| 261,404 | | |
| 781,092 | | |
| 503,160 | |
Cost and expenses | |
| | | |
| | | |
| | | |
| | |
Cost of product revenues | |
| 169,850 | | |
| 142,808 | | |
| 328,683 | | |
| 290,562 | |
Cost of licensing and other revenues | |
| 329 | | |
| 341 | | |
| 636 | | |
| 711 | |
Research and development | |
| 89,109 | | |
| 78,173 | | |
| 177,746 | | |
| 160,479 | |
Selling, general
and administrative | |
| 197,965 | | |
| 152,508 | | |
| 392,243 | | |
| 302,135 | |
Total cost and expenses | |
| 457,253 | | |
| 373,830 | | |
| 899,308 | | |
| 753,887 | |
Loss from operations | |
| (43,902 | ) | |
| (112,426 | ) | |
| (118,216 | ) | |
| (250,727 | ) |
Interest expense | |
| (3,127 | ) | |
| (3,177 | ) | |
| (6,251 | ) | |
| (6,238 | ) |
Interest and other income, net | |
| 10,457 | | |
| 4,518 | | |
| 20,724 | | |
| 9,103 | |
Loss before income taxes | |
| (36,572 | ) | |
| (111,085 | ) | |
| (103,743 | ) | |
| (247,862 | ) |
Income tax (expense) benefit | |
| (892 | ) | |
| 282 | | |
| (1,320 | ) | |
| 122 | |
Net loss | |
$ | (37,464 | ) | |
$ | (110,803 | ) | |
$ | (105,063 | ) | |
$ | (247,740 | ) |
Unrealized gain on available-for-sale
securities, net of tax | |
| 834 | | |
| 2,595 | | |
| 1,727 | | |
| 7,159 | |
Comprehensive loss | |
$ | (36,630 | ) | |
$ | (108,208 | ) | |
$ | (103,336 | ) | |
$ | (240,581 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (0.30 | ) | |
$ | (0.97 | ) | |
$ | (0.86 | ) | |
$ | (2.20 | ) |
Weighted-average number of shares used in computing basic
and diluted net loss per share: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 122,853 | | |
| 113,690 | | |
| 121,834 | | |
| 112,734 | |
Exhibit 99.2
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img001.jpg)
Natera, Inc. Investor presentation Q2 2024 Earnings Call August 8, 2024
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img002.jpg)
Not for reproduction or further distribution. This presentation contains forward - looking statements under the meaning of the Private Securities Litigation Reform Act of 1995 . All statements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partnerships and potential acquisitions, our user experience, our clinical trials and studies, and our strategies, goals and general business and market conditions are forward - looking statements . 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 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 our 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 ; 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, if and when the FDA begins actively regulating our tests pursuant to recently enacted FDA regulations ; litigation or other proceedings, resulting from either third party claims of intellectual property infringement or third party infringement of our technology, is costly, 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 . We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our periodic reports on Forms 10 - K and 10 - Q and in other filings we make with the SEC from time to time . Moreover, we operate in a very competitive and rapidly changing environment . New risks emerge from time to time . It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statement . In light of these risks, uncertainties and assumptions, the forward - looking events and circumstances discussed in this presentation may not occur and our actual results could differ materially and adversely from those anticipated or implied . As a result, you should not place undue reliance on our forward - looking statements . Except as required by law, we undertake no obligation to update publicly any forward - looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations . We file reports, proxy statements, and other information with the SEC . Such reports, proxy statements, and other information concerning us is available at http : //www . sec . gov . Requests for copies of such documents should be directed to our Investor Relations department at Natera, Inc . , 13011 McCallen Pass, Building A Suite 100 , Austin, TX 78753 . Our telephone number is ( 650 ) 980 - 9190 . 2 Safe harbor statement
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img003.jpg)
Not for reproduction or further distribution. 3 Q2 2024 highlights and recent business updates • Revenue of $413M in Q2 2024 vs $261M in Q2 2023; year - over - year growth of 58%. • ~760K total tests processed in Q2 2024 vs ~617K in Q2 2023; year - over - year growth of 23%. • Performed ~125K oncology tests in Q2 2024 vs ~84K in Q2 2023; year - over - year growth of 50%. Signatera clinical units grew ~13K units over Q1 2024, one of the best growth quarters ever. • Gross margin 1 of 58.8% in Q2 2024 vs 45.2% in Q2 2023. • Raising FY2024 guidance: revenues now expected to be $1,490M - $1,520M ; gross margin now expected to be 54% - 56%. Opex guide unchanged. • Recent business updates include: » ALTAIR readout now expected to be presented at ASCO GI (early 2025). » Presenting 36 - mos. GALAXY data at ESMO Congress 2024, representing the first prospective overall survival data for Signatera TM in colorectal cancer. » Presented impactful, new data at the 2024 ASCO Annual Meeting. » Endorsement for comprehensive genetic testing in kidney disease from National Kidney Foundation consensus paper. » Launched differentiated new feature for Prospera Heart TM . » Federal Appeals Court upheld preliminary injunction of competitive MRD assay. 1. Gross margin is calculated as gross profit divided by GAAP total revenues. Gross profit is calculated as GAAP total revenues les s GAAP cost of revenues.
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img004.jpg)
Not for reproduction or further distribution. 195K 234K 376K 500K 617K 760K 0K 100K 200K 300K 400K 500K 600K 700K 800K Q2'19 Q2'20 Q2'21 Q2'22 Q2'23 Q2'24 Quarterly volumes demonstrate continued momentum Core Volume Drivers • New features and data leading to women’s health account wins • New data and guidelines driving organ health • Signatera continues to ramp 4
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img005.jpg)
Not for reproduction or further distribution. 52K 61K 72K 81K 91K 106K 118K 40K 50K 60K 70K 80K 90K 100K 110K 120K 130K 4Q22 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 64K 71K 84K 89K 98K 115K 125K 55K 65K 75K 85K 95K 105K 115K 125K 135K 4Q22 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 5 Signatera clinical units jump again, up ~13K units in Q2 vs Q1 Total oncology tests processed Signatera clinical tests processed ~13K ~11K
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img006.jpg)
Not for reproduction or further distribution. $194 $198 $242 $261 $368 $413 $M $50M $100M $150M $200M $250M $300M $350M $400M $450M Q1 '22 Q2 '22 Q1 '23 Q2 '23 Q1 '24 Q2 '24 Strong sequential revenue growth in Q2 • ~58% revenue growth over Q2’23 • Strong gross margin improvement • Growth in Signatera ASP Total revenues: growth comparison of Q2 vs Q1 over time ($ in millions) 2 % 12 % 8 % 6
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img007.jpg)
Not for reproduction or further distribution. 39% 45% 45% 51% 57% 59% 35% 40% 45% 50% 55% 60% 65% 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 7 ASPs and COGS execution ahead of plan • Underlying gross margins (excluding true ups) increased ~200 bps in Q2 over Q1 • Significant sequential step up in ASPs • Cash collection exceeding expectations, driving true - ups • Continued momentum in COGS projects ~ 2 % true up benefit ~4% true up benefit Gross margins quarterly trend ~4% true up benefit
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img008.jpg)
Not for reproduction or further distribution. (180) (160) (140) (120) (100) (80) (60) (40) (20) 0 20 Trend for quarterly cash burn / cash flow ($ in millions) 8 1. Non - GAAP cash burn included $13.4 million change in unrealized loss and amortization or accretion on investments from the GAAP S tatement of Cash Flows during the first quarter 2022. Non - GAAP c ash burn included $3.8 million change in unrealized gain and amortization or accretion on investments from the GAAP Statement of Cash Flows during the first quarter 2 023 . 2. Non - GAAP cash (outflows) inflows for the quarter ended June 30, 2024, is derived from the GAAP Statement of Cash Flows as follow s: net cash provided by operating activities of $4.0 million, net cash provided by financing activities of $11.0 million, offset by net cash used in investing activities for purchases of property and equipment and acquisition of an asset of $11.7 million. Second consecutive cash flow breakeven quarter ($162) 1 ($110) 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 4Q23 1Q24 ($113) ($88) ($86) 1 ($78) ($38) ($61) $3 $3 2 2Q24 • Executing the strategy: cash flow improvement driven by continued revenue growth, improving gross margins, and stable operating expenses • Generated cash in Q2 despite seasonal headwinds in women’s health and increased investments in SG&A focused on future growth
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img009.jpg)
Not for reproduction or further distribution. 9 1. Franceschini N, et al., on behalf of the NKF Genetic Testing Working Group, Advancing Genetic Testing in Kidney Diseases: Report From a Na ti onal Kidney Foundation Working Group, American Journal of Kidney Diseases (2024), doi : https://www.ajkd.org/article/S0272 - 6386(24)00871 - 0/fulltext National Kidney Foundation endorses genetic testing for kidney disease Recommends a large multi - disease genetic kidney panel as the primary choice for genetic testing. Recommends genetic testing for the majority of CKD patients, providing an algorithm to help implement in routine practice. Recognizes the clinical utility and benefits of genetics in CKD. With NKF and KDIGO, two of the major nephrology organizations now recommend genetic testing. New consensus paper from NKF 1 :
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img010.jpg)
Not for reproduction or further distribution. 10 1. Kim, P et al. A Two - Threshold dd - cfDNA Algorithm for Detection of Rejection After Heart Transplant. J Heart Lung Transplant ; 2024; 43(4):S205 - S206 Launched Prospera Heart with DQS, enhancing detection of rejection for transplant patients Rejection Types AMR & ACR AMR & ACR Sensitivity 80.0% 88.2% Specificity 76.1% 84.2% • 37% reduction in false positive results. • DQS can identify cases of rejection where anomalies in background cfDNA may confound the donor fraction. Two thresholds for a single rejection risk result Prospera Heart v1 dd - cfDNA % NEW Prospera Heart with DQS dd - cfDNA % + DQS
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img011.jpg)
Not for reproduction or further distribution. Commercial growth drivers for Signatera 11 Adjuvant Decision Making Surveillance Detecting recurrence earlier than imaging alone, while it may still be treated with curative intent (e.g., surgery in CRC) Informing risk - based decisions about adjuvant systemic therapy after curative intent surgery Therapy Response Monitoring Assessing response to systemic therapy, earlier and more accurately than imaging alone, to enable faster and better decisions about treatment strategy Note: Signatera ordering based on internal estimates. x Growth in new physician starts, with over 40% of oncologists ordering a Signatera test in Q2 x Growth in new patients across all disease indications, led by colorectal cancer and breast cancer x Fast TAT and great user experience
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img012.jpg)
Not for reproduction or further distribution. 1. Marla Lipsyc - Sharf et al. Impact of circulating tumor DNA ( ctDNA ) surveillance on clinical care for patients with stage I - III breast cancer: Findings from a multi - institutional study. ASCO Ann ual Meeting 2024. 88% of patients remained ctDNA - negative, providing reassurance and peace of mind. 91% of Signatera - positive patients had a change in treatment plan, with many achieving sustained ctDNA clearance. Study from ASCO 2024 highlights current utility in breast cancer 1 Multi - Institutional Real - World Study To determine whether ctDNA detection in the adjuvant and surveillance settings could impact the care plan for patients with early breast cancer (stage I - III) Objective Institutions UCLA, Mass General, Washington University, Cornell Study Design 464 early breast cancer patients with ctDNA testing 12
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img013.jpg)
Not for reproduction or further distribution. 13 Recent peer - reviewed publications across multiple indications, in top journals To date, Natera has published >85 oncology papers, including >25 YTD 2024 Multicenter, real - world evidence study ctDNA+ patients at pre - RC, MRD and surveillance had worse DFS ctDNA - patients showed no benefit of adjuvant chemotherapy JCO Precision Oncology 1 JAMA Oncology 2 European Urology Oncology 3 JCO Precision Oncology 4 • Multicenter, prospective, observational study • Signatera TM sensitivity of 95% at the time of enrollment • ctDNA+ patients had 20x higher risk of recurrence • Open - label, single arm, phase II, interventional study • ctDNA+ patients at 4 weeks post - resection, leads to worse PFS and OS • Multicenter , real - world evidence study • ctDNA+ patients at pre - RC, MRD and surveillance had worse DFS • ctDNA - patients showed no benefit of adjuvant chemotherapy • Expanded EBLIS study with 12 years of follow - up • Relapse detection - 38 months earlier than imaging • ctDNA+ patients had worse RFS/OS Merkel Cell Carcinoma Pancreatic Cancer Muscle - Invasive Bladder Cancer Breast Cancer 1. Akaike T, Thakuria M, Silk AW, et al. Circulating Tumor DNA Assay Detects Merkel Cell Carcinoma Recurrence, Disease Progression, and Minimal Res id ual Disease: Surveillance and Prognostic Implications. J Clin Oncol. 2024. doi : 10.1200/JCO.23.02054. 2. Cecchini M, Salem RR, Robert M, et al. Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024. doi:10.1001/jamaoncol.2024.1575 3. Sfakianos JP, Basu A, Laliotis G, et al. Association of Tumor - informed Circulating Tumor DNA Detectability Before and After Radical Cystectomy with Disease - fr ee Survival in Patients with Bladder Cancer. European Urology Oncology. 2024. https://doi.org/10.1016/j.euo.2024.07.001 4. Shaw JA, Page K, Wren E, et al. Serial postoperative circulating tumor DNA assessment has strong prognostic value during long - te rm follow - up in patients with breast cancer. JCO Precis Oncol. 2024;8:e2300456.
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img014.jpg)
Not for reproduction or further distribution. 14 Trial GALAXY (36 - mos outcomes data) ALTAIR IMvigor011 CIRCULATE France TREAT ctDNA VEGA MODERN CIRCULATE - US Indication CRC CRC Bladder CRC Breast CRC Bladder CRC RCT/NR NR RCT RCT RCT RCT RCT RCT RCT Phase N/A III III III III III II/III II/III Category Prospective, observational Escalation Escalation and de - escalation Escalation Escalation De - escalation Escalation and de - escalation Escalation and de - escalation Est. # of patients ~2,200 ~240 ~800 ~2,130 ~220 ~1,240 ~1,250 ~1,900 2024 2025 2026 and Beyond Key phase III clinical trials in colorectal, bladder and breast cancers
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img015.jpg)
Not for reproduction or further distribution. FY24 Q2 financial overview 15 1. Cash and investments also include cash equivalents and restricted cash. 2. This balance reflects net carrying value for the Convertible Senior Notes under ASC 470 - 20 while the gross principal amounts out standing is $287.5 million as of June 30, 2024. ($ in millions, except for per share data) Balance sheet Jun 30, 2024 Dec 31, 2023 Change Y/Y Cash & investments 1 $887.1 $879.0 $8.1 UBS line of credit $80.4 $80.4 $ — Convertible senior notes 2 $283.6 $282.9 $0.7 FY24 Q2 FY23 Q2 Change Y/Y Product revenues $411.4 $258.3 $153.1 Licensing and other revenues $2.0 $3.1 ($1.1) Total revenues $413.4 $261.4 $152.0 Gross margin % 58.8% 45.2% 13.6% R&D $89.1 $78.2 $10.9 SG&A $198.0 $152.5 $45.5 Net loss per diluted share ($0.30) ($0.97) $0.67
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img016.jpg)
Not for reproduction or further distribution. Guide ($ millions) Original Q1 24 Current Key drivers Revenue $ 1,320 – $1, 350 $ 1,420 – $1, 450 $ 1,490 – $1,520 Continued volume growth, conservative ASPs, strong oncology contribution Gross margin % revenue 50 % – 53 % 53 % – 55 % 54 % – 56 % Reflects higher Q2 ASPs holding for rest of year SG&A $ 630 – $ 650 $ 700 – $ 750 $ 700 – $ 750 Executing to growth plans set in Q1 R&D $325 – $345 $ 350 – $ 375 $ 350 – $ 375 Continued substantial investment in R&D Cash burn ($ 75) – ($ 50) ( $25) - $25 ( $25) - $25 Cash flow breakeven for full year intact Raising 2024 guidance 16
![](https://www.sec.gov/Archives/edgar/data/1604821/000110465924087273/tm2420614d1_ex99-2img017.jpg)
©202 4 Natera, Inc. All Rights Reserved. Not for reproduction or further distribution. ®
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