Recent Accomplishments & Highlights
- Generated total revenues of
$49.3 million in the fourth quarter of 2016 compared to$52.9 million in the fourth quarter of 2015. Revenues for the full year 2016 were$217.1 million compared to$190.4 million for the full year 2015, an increase of approximately 14%. - Processed greater than 117,000 tests, including approximately 112,000 tests accessioned in
Natera's laboratory and approximately 5,100 units processed through its Constellation software platform (Constellation units), in the fourth quarter of 2016, compared to approximately 96,000 tests processed, including approximately 93,000 tests accessioned and approximately 3,000 Constellation units, in the fourth quarter of 2015, which represents an increase of approximately 22%. Greater than 447,000 tests, including approximately 430,000 tests accessioned and approximately 17,000 Constellation units, were processed in the full year 2016 compared to greater than 317,000 tests, including greater than 310,000 tests accessioned and greater than 7,000 Constellation units, in 2015, which represents an increase of approximately 41%. - Accessioned greater than 84,000 Panorama tests in the fourth quarter of 2016 compared to approximately 73,000 tests accessioned in the fourth quarter of 2015, an increase of approximately 15%. Greater than 331,000 Panorama tests were accessioned in the full year 2016 compared to approximately 255,000 tests accessioned in 2015, an increase of approximately 30%.
- Accessioned greater than 22,000 Horizon carrier screening tests in the fourth quarter of 2016 compared to approximately 16,000 Horizon carrier screening tests accessioned in the fourth quarter of 2015, an increase of approximately 38%. Greater than 80,000 Horizon tests were accessioned in the full year 2016, compared to approximately 42,000 Horizon tests accessioned in 2015, an increase of approximately 90%.
- Announced the launch of the Evercord™ cord blood and tissue banking service, a new product offering that enables expectant parents to collect, store and retrieve their newborn's cord blood and tissue for potential therapeutic use in roughly 75 established diseases and a host of potential regenerative medicine applications, and placing
Natera in a position to generate the genome of an individual soon after birth. - Previewing launch plans of a significant new addition to
Natera's suite of noninvasive prenatal tests that identifies risk for severe conditions which have a combined incidence roughly of 1 in 600. - Launched Version 3 of Panorama, which is intended to drive further reductions in cost of goods sold for Panorama while maintaining best in class test performance for both fetal aneuploidies and microdeletions screening.
- Selected to participate in the I-SPY 2 TRIAL, a multi-center study evaluating the safety and efficacy of investigational therapies combined with neoadjuvant treatment in women with newly diagnosed, locally advanced breast cancer.
Natera will be analyzing blood samples at various points throughout patient treatment to evaluate the effectiveness of liquid biopsy in monitoring tumor burden, treatment response, and residual disease, as compared to traditional imaging methods. - Announced results from DNAFirst Study published in Genetics in Medicine demonstrating the clinical utility of Panorama as a first line fetal aneuploidy screen in a general population. Out of 2,681 women included in the study, Panorama demonstrated a sensitivity of 100% (12/12) with no false negatives and a 75% positive predictive value.
- More than 50 percent of commercially insured patient lives now have access to NIPT, regardless of maternal age or risk factors. Over 40 health plans encompassing more than 104 million lives now cover NIPT for all women – including
Cigna , Anthem and mostBlue Cross and Blue Shield plans. - Announced the availability of a microdeletions testing application for new and existing Constellation licensees worldwide.
"We are pleased with the progress we made in the quarter," said
Fourth Quarter and Year Ended
Total revenues were
Gross profit for the three months ended December 31, 2016 was $11.3 million, representing a 22.9% gross margin, compared to $21.1 million, representing a 39.9% gross margin in the same period of the prior year.* Gross profit for the year ended
Total operating expenses, representing research and development expenses, and selling, general and administrative expenses, for the three months ended December 31, 2016 were
Loss from operations for the fourth quarter of 2016 was $ 37.7 million compared to loss from operations of
Net loss for the three months ended
At
2017 Financial Outlook
* Gross profit is calculated as GAAP total revenues less GAAP cost of product 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 2017 to be between
About
Product offerings include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation; and Evercord™, a cord blood and tissue banking service offered at birth to expectant parents.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. These tests have not been cleared or approved by the
Conference Call Information
Event: |
Natera's Fourth Quarter and Year-End 2016 Results Conference Call |
Date: |
Wednesday, March 7, 2016 |
Time: |
1:30 p.m. PT (4:30 p.m. ET) |
Live Dial-In: |
(877) 823-0171, Domestic |
(617) 500-6932, International |
|
Conference ID: |
77689151 |
Webcast: |
investor.natera.com |
A webcast replay will be available at investor.natera.com.
Forward-Looking Statements
This release contains forward-looking statements, including statements regarding
These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we derive most of our revenues from Panorama, and if our efforts to further increase the use and adoption of Panorama or to develop new products and services in the future do not succeed, our business will be harmed; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; uncertainty in the development and commercialization of our enhanced or new tests or services, including future cancer products, could materially adversely affect our business, financial condition and results of operations; our quarterly results may fluctuate significantly; we may be unable to compete successfully with either existing or future prenatal testing products or services; our cloud-based distribution model may be difficult to implement, and we may not be able to commercialize this model if we do not comply with ongoing regulatory requirements; implementation of our cloud-based distribution model may negatively impact our financial results and results of operations; we may be subject to increased compliance risks as a result of our rapid growth, including our recent growth in and dependence on our direct sales force; we rely on internal and third-party data centers and platforms to host our laboratory and cloud-based software, and any interruptions of service or failures may impair the operations of our laboratory or the delivery of our cloud-based software and harm our business; if our products do not perform as expected, our operating results, reputation and business will suffer; if we are unable to successfully grow revenues for our products or services in addition to Panorama, our business and result of operations may be adversely affected; the results of our clinical studies may not support 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; 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; we may be unable to expand third-party payer coverage and reimbursement for Panorama and our other tests, or we may be required to refund reimbursements already received; and third-party payers may withdraw coverage or provide lower levels of reimbursements due to changing policies, billing complexities or other factors.
Additional risks and uncertainties that could affect
Contacts
mbrophy@natera.com
Lzobkiw@natera.com
Natera, Inc. |
|||||||
Consolidated Balance Sheets |
|||||||
(Unaudited) |
|||||||
(In thousands, except per share data) |
|||||||
December 31, |
December 31, |
||||||
2016 |
2015 |
||||||
Assets |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
15,256 |
$ |
28,947 |
|||
Restricted cash, current portion |
1,092 |
901 |
|||||
Short-term investments |
130,860 |
201,586 |
|||||
Accounts receivable, net of allowance of $1,890 in 2016 and $971 in 2015 |
13,396 |
5,862 |
|||||
Inventory |
6,414 |
8,093 |
|||||
Prepaid expenses and other current assets |
7,097 |
5,337 |
|||||
Total current assets |
174,115 |
250,726 |
|||||
Property and equipment, net |
32,289 |
12,710 |
|||||
Restricted cash, long term portion |
342 |
683 |
|||||
Other assets |
3,934 |
1,121 |
|||||
Total assets |
$ |
210,680 |
$ |
265,240 |
|||
Liabilities and Stockholders' Equity (Deficit) |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
11,479 |
$ |
7,332 |
|||
Accrued compensation |
11,067 |
8,552 |
|||||
Other accrued liabilities |
19,879 |
18,708 |
|||||
Deferred revenue |
574 |
144 |
|||||
Short-term debt financing |
49,624 |
42,090 |
|||||
Warrants |
3,792 |
3,649 |
|||||
Total current liabilities |
96,415 |
80,475 |
|||||
Deferred rent, net of current portion |
7,789 |
— |
|||||
Total liabilities |
104,204 |
80,475 |
|||||
Commitments and contingencies |
|||||||
Stockholders' equity: |
|||||||
Preferred stock, $0.0001 par value: 50,000 shares authorized; no shares issued and outstanding at December 31, 2016 and 2015, respectively |
— |
— |
|||||
Common stock, $0.0001 par value: 750,000 shares authorized at both December 31, 2016 and December 31, 2015, respectively; 52,665 and 50,346 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively |
5 |
5 |
|||||
Additional paid in capital |
453,044 |
436,259 |
|||||
Accumulated deficit |
(345,848) |
(250,083) |
|||||
Accumulated other comprehensive loss |
(725) |
(1,416) |
|||||
Total stockholders' equity |
106,476 |
184,765 |
|||||
Total liabilities and stockholders' equity |
$ |
210,680 |
$ |
265,240 |
Natera, Inc. |
||||||||||
Consolidated Statements of Operations and Comprehensive Loss |
||||||||||
(Unaudited) |
||||||||||
(In thousands, except per share data) |
||||||||||
Year ended December 31, |
||||||||||
2016 |
2015 |
2014 |
||||||||
Revenues |
||||||||||
Product revenues |
$ |
213,968 |
$ |
188,168 |
$ |
157,308 |
||||
Licensing and other revenues |
3,106 |
2,187 |
1,981 |
|||||||
Total revenues |
217,074 |
190,355 |
159,289 |
|||||||
Cost and expenses |
||||||||||
Cost of product, licensing and other revenues |
135,574 |
112,845 |
78,396 |
|||||||
Research and development |
41,862 |
27,711 |
17,292 |
|||||||
Selling, general and administrative |
136,126 |
109,637 |
62,936 |
|||||||
Total cost and expenses |
313,562 |
250,193 |
158,624 |
|||||||
(Loss) income from operations |
(96,488) |
(59,838) |
665 |
|||||||
Interest expense |
(533) |
(3,505) |
(4,219) |
|||||||
Interest benefit from changes in the fair value of long term debt |
— |
964 |
118 |
|||||||
Interest and other income (expense), net |
1,398 |
(7,896) |
(1,716) |
|||||||
Loss before income taxes |
(95,623) |
(70,275) |
(5,152) |
|||||||
Income tax expense |
(142) |
— |
— |
|||||||
Net loss |
$ |
(95,765) |
$ |
(70,275) |
$ |
(5,152) |
||||
Unrealized gain (loss) on available-for-sale securities, net of tax |
691 |
(1,416) |
— |
|||||||
Comprehensive loss |
$ |
(95,074) |
$ |
(71,691) |
$ |
(5,152) |
||||
Basic and diluted net loss per share |
$ |
(1.86) |
$ |
(2.68) |
$ |
(1.07) |
||||
Weighted-average number of shares used in computing basic and diluted net loss per share |
51,576 |
26,204 |
4,800 |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/natera-reports-fourth-quarter-and-fiscal-year-2016-financial-results-300419555.html
SOURCE