Recent Accomplishments & Highlights
- Processed approximately 234,100 tests in the second quarter of 2020 compared to approximately 194,200 tests processed in the second quarter of 2019, an increase of 21%.
- Generated total revenues of
$86.5 million in the second quarter of 2020 compared to$74.4 million in the second quarter of 2019. - Published Signatera™ study in Nature Cancer validating ability to monitor tumor response to immune therapy in 25 different types of solid cancer.
- Launched the PEDAL study designed to demonstrate Prospera test enhancements at the
American Transplant Conference . - Presented four abstracts, including one oral presentation and three poster presentations, at the
American Society for Clinical Oncology conference demonstrating the performance of Signatera in areas including colorectal cancer and hepatocellular carcinoma. - Enrolled first patients in both CIRCULATE-Japan and BESPOKE CRC for Signatera in colorectal cancer, and in PROACTIVE for Prospera.
- Received positive coverage from Noridian for Prospera; commenced full commercial launch.
- Received the Force for Change Illuminator Award from Leading Women Entrepreneurs.
"The business was very resilient in the second quarter," said
Second Quarter Ended
Total revenues were
In the three months ended
Gross profit* for the three months ended June 30, 2020 and 2019 was $39.5 million and
Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the second quarter of 2020 were
Loss from operations for the second quarter of 2020 was $51.6 million compared to $28.6 million for the same period of the prior year.
Net loss for the second quarter of 2020 was
At
2020 Financial Outlook
Natera anticipates 2020 total revenue of
* 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 burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2020 to be between
Test Volume Summary |
||||||||||||
Unit |
Q2 2020 |
Q2 2019 |
Definition |
|||||||||
Tests processed |
234,000 |
194,200 |
Tests accessioned in our laboratory plus units processed outside of our laboratory |
|||||||||
Tests accessioned |
221,600 |
181,600 |
Test accessioned in our laboratory |
|||||||||
Tests reported in our |
208,400 |
174,800 |
Total tests reported in our laboratory less units reported outside of our laboratory including Evercord units in prior periods |
About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Conference Call Information
Event: |
Natera's Second Quarter 2020 Financial Results Conference Call |
Date: |
Wednesday, August 5, 2020 |
Time: |
|
Live Dial-In: |
(800) 708-4540, Domestic |
(847) 619-6397, International |
|
Conference Password: |
49854736 |
Webcast: |
A webcast replay will be available at investor.natera.com.
Forward-Looking Statements
This release contains forward-looking statements, including regarding the company's business operations in light of the COVID-19 pandemic. Any forward-looking statements contained in this 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. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.
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 operating our business in light of the COVID-19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and successfully commercialize new products, including Signatera and Prospera; 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 not be successful in commercializing our cloud-based distribution model; our products may not perform as expected; the results of our clinical studies may not be compelling to professional societies or payors as supporting the use of our tests, particularly in the average-risk pregnancy population or for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if our primary CLIA-certified laboratory facility 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 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, such as the increased focus by third-party payers on requiring that prior authorization be obtained prior to conducting a test; 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, 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
Natera assumes no obligation to, and does not currently intend to, update any such forward-looking statements after the date of this release.
Contacts
Investor Relations
Media
|
||||||||||||||
Condensed Consolidated Balance Sheets |
||||||||||||||
(Unaudited) |
||||||||||||||
(in thousands) |
||||||||||||||
|
|
|||||||||||||
2020 |
2019 |
|||||||||||||
(1) |
||||||||||||||
Assets |
||||||||||||||
Current assets: |
||||||||||||||
Cash and cash equivalents |
$ |
77,322 |
$ |
61,926 |
||||||||||
Restricted cash |
55 |
55 |
||||||||||||
Short-term investments |
493,852 |
379,065 |
||||||||||||
Accounts receivable, net of allowance of |
58,706 |
53,351 |
||||||||||||
Inventory |
18,033 |
12,394 |
||||||||||||
Prepaid expenses and other current assets, net |
15,536 |
16,376 |
||||||||||||
Total current assets |
663,504 |
523,167 |
||||||||||||
Property and equipment, net |
25,925 |
23,283 |
||||||||||||
Operating lease right-of-use assets |
21,475 |
23,730 |
||||||||||||
Other assets |
12,357 |
12,476 |
||||||||||||
Total assets |
$ |
723,261 |
$ |
582,656 |
||||||||||
Liabilities and Stockholders' Equity |
||||||||||||||
Current liabilities: |
||||||||||||||
Accounts payable |
$ |
3,450 |
$ |
8,604 |
||||||||||
Accrued compensation |
16,583 |
16,088 |
||||||||||||
Other accrued liabilities |
53,082 |
49,043 |
||||||||||||
Deferred revenue, current portion |
52,392 |
56,016 |
||||||||||||
Short-term debt financing |
50,053 |
50,123 |
||||||||||||
Total current liabilities |
175,560 |
179,874 |
||||||||||||
Long-term debt financing |
197,476 |
73,656 |
||||||||||||
Deferred revenue, long-term portion |
22,533 |
23,808 |
||||||||||||
Operating lease liabilities, long-term portion |
23,115 |
26,297 |
||||||||||||
Other long-term liabilities |
310 |
310 |
||||||||||||
Total liabilities |
418,994 |
303,945 |
||||||||||||
Commitments and contingencies |
||||||||||||||
Stockholders' equity: |
||||||||||||||
Common stock (2) |
8 |
8 |
||||||||||||
Additional paid in capital |
1,093,072 |
976,955 |
||||||||||||
Accumulated deficit |
(794,583) |
(699,171) |
||||||||||||
Accumulated other comprehensive income |
5,770 |
919 |
||||||||||||
Total stockholders' equity |
304,267 |
278,711 |
||||||||||||
Total liabilities and stockholders' equity |
$ |
723,261 |
$ |
582,656 |
(1) |
The condensed, consolidated balance sheet at |
(2) |
As of |
|
||||||||||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss |
||||||||||||||||||||||||
(Unaudited) |
||||||||||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||||||||||
Three months ended |
Six months ended |
|||||||||||||||||||||||
|
|
|||||||||||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||||||||||
Revenues |
||||||||||||||||||||||||
Product revenues |
$ |
80,414 |
$ |
65,099 |
$ |
167,460 |
$ |
128,463 |
||||||||||||||||
Licensing and other revenues |
6,058 |
9,256 |
13,024 |
12,716 |
||||||||||||||||||||
Total revenues |
86,472 |
74,355 |
180,484 |
141,179 |
||||||||||||||||||||
Cost and expenses |
||||||||||||||||||||||||
Cost of product revenues |
42,731 |
41,382 |
84,251 |
82,987 |
||||||||||||||||||||
Cost of licensing and other revenues |
4,208 |
2,443 |
7,666 |
4,141 |
||||||||||||||||||||
Research and development |
23,005 |
12,124 |
41,230 |
23,559 |
||||||||||||||||||||
Selling, general and administrative |
68,188 |
47,042 |
133,869 |
90,874 |
||||||||||||||||||||
Total cost and expenses |
138,132 |
102,991 |
267,016 |
201,561 |
||||||||||||||||||||
Loss from operations |
(51,660) |
(28,636) |
(86,532) |
(60,382) |
||||||||||||||||||||
Interest expense |
(4,038) |
(2,721) |
(6,502) |
(5,445) |
||||||||||||||||||||
Interest and other income, net |
1,924 |
836 |
3,911 |
1,289 |
||||||||||||||||||||
Loss on debt extinguishment |
(5,848) |
— |
(5,848) |
— |
||||||||||||||||||||
Loss before income taxes |
(59,622) |
(30,521) |
(94,971) |
(64,538) |
||||||||||||||||||||
Income tax expense |
(15) |
(1,895) |
(38) |
(1,969) |
||||||||||||||||||||
Net loss |
$ |
(59,637) |
$ |
(32,416) |
$ |
(95,009) |
$ |
(66,507) |
||||||||||||||||
Unrealized gain on available-for-sale securities, net of tax |
104 |
1,061 |
4,850 |
1,347 |
||||||||||||||||||||
Comprehensive loss |
$ |
(59,533) |
$ |
(31,355) |
$ |
(90,159) |
$ |
(65,160) |
||||||||||||||||
Net loss per share: |
||||||||||||||||||||||||
Basic and diluted |
$ |
(0.75) |
$ |
(0.48) |
$ |
(1.21) |
$ |
(1.01) |
||||||||||||||||
Weighted-average number of shares used in computing basic and diluted net loss per share: |
||||||||||||||||||||||||
Basic and diluted |
79,069 |
68,224 |
78,681 |
65,542 |
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