-- Grew volume by more than 300% year over year, secured Medicare
reimbursement and multiple private payer contracts, expanded test menu
with more than 1,000 genes in production, lowered COGS --
-- Hosting conference call at 4:45 pm ET / 1:45 pm PT --
SAN FRANCISCO--(BUSINESS WIRE)--
Invitae
Corporation (NYSE:
NVTA), a genetic information company, today announced financial and
operating results for the first quarter ended March 31, 2016. The
company executed on all four of its key metrics, including important
progress on reimbursement.
“We made significant strides on reimbursement early this year with
payments initiated from Medicare, as well as new contracts with several
Blue Cross Blue Shield regional plans,” said Randy Scott, chairman and
CEO of Invitae. “We believe this is just the start of a major transition
in the payer industry toward more affordable and accessible genetic
testing, resulting from major advances in DNA sequencing technology and
the rapid adoption of multi-gene panels into clinical guidelines and
medical practice.”
The company reported total revenue of $4.0 million in the first quarter
of 2016, compared to $1.2 million in the first quarter of 2015.
Operating expenses, excluding the costs of tests delivered, were $23.3
million compared to $16.6 million for the first quarter of 2015. Net
loss was $25.6 million in the first quarter of 2016, or a $0.80 loss per
share. Also included in our operating expenses were non-cash expenses of
approximately $3.7 million, including depreciation, equity compensation,
and non-cash rent expense for its new lab facility, which the company
expects to occupy later this year.
At March 31, 2016, cash, cash equivalents, restricted cash, and
marketable securities totaled approximately $108.7 million.
Following are recent highlights:
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Increased volume by delivering more than 9,700 billable reports and
accessioning approximately 10,000 samples.
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Reduced cost of goods sold (COGS) from less than $700 to approximately
$600 per sample accessioned.
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Achieved mid-year goal of more than 1,000 genes in production,
releasing new content in March with hundreds of additional genes and
expanded panels for neurology, pediatrics, and rare diseases, and
introducing an entirely new clinical testing area designed to
complement newborn screening for metabolic and immunological
conditions:
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Expanded neurological menu: Testing for more than 30 disorders,
including muscular dystrophies, myopathies, as well as congenital
myasthenic syndrome, small fiber neuropathy and malignant
hyperthermia susceptibility, among others.
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Expanded pediatric and rare disease menu: Testing for more than 60
disorders, covering pediatric immunology, including the most
common forms of severe combined immunodeficiency and periodic
fever syndromes. Invitae has also expanded its rare disease
offering to include testing for 20 additional rare diseases.
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New inherited metabolic disorders and newborn screening
confirmation: Testing for more than 50 disorders, covering the
majority of metabolic conditions, for which over 4 million U.S.
newborns are screened each year. Invitae has also added a panel
covering the common causes of congenital disorders of
glycosylation and the most common forms of severe combined
immunodeficiency screened for in most states in the U.S.
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Signed additional contracts with institutions, increasing its total
number of active institutional customers to 70.
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Began receiving payments in April from the Centers for Medicare and
Medicaid Services (CMS) for Invitae’s multi-gene tests for hereditary
breast cancer-related disorders under new billing guidelines and an
expanded coverage policy by Palmetto's MolDX program. The tests are
billed under the current procedure terminology (CPT) code 81432, which
became effective on January 1, 2016. Payments are made by Noridian,
CMS’s administrative contractor for California.
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Signed agreements with multiple regional Blue Cross Blue Shield
affiliates, providing coverage for patients in a total of five states,
as well as those covered by the Federal Employee Plan.
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Presented a dozen posters and presentations at the 2016 American
College of Medical Genetics and Genomics Annual Clinical Genetics
Meeting, including:
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Data from a collaboration with the University
of California, Santa Cruz comparing publicly available
classifications of variants in BRCA1 and BRCA2 across seven
established clinical laboratories in approximately 20,000
representative patients, made public through ClinVar. The study
found a concordance rate of 98.5% for classifications of BRCA1 and
BRCA2 variants across major clinical testing laboratories.
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Data from an online survey of 101 clinicians and 150
patients/caregivers in the rare disease community demonstrating
the impact of delayed diagnosis and obstacles for patients and
clinicians. Patients reported receiving an average of three
preliminary diagnoses and seven diagnostic tests and/or procedures
during their diagnostic journeys, which lasted an average of 3.9
years. During this time, 39% of patients felt they had paid for
ineffective treatments or interventions that were based in part on
an incorrect diagnosis. Approximately 23% of patients received
multiple genetic tests. Obstacles for patients in the diagnostic
journey included lack of information (76%) and inadequate
insurance coverage (21%), resulting in 60% of patients incurring
unexpected financial burden and 29% going into debt. The poster
was acknowledged by ACMG as a top poster presented at meeting this
year.
“We’re excited to continue increasing the number of people we can serve
who suffer from genetic conditions, and we believe our high quality,
comprehensive, affordable offering will continue to put us in a strong
position to serve as the partner of choice for inherited genetic testing
and associated services,” said Sean George, president and COO of
Invitae. “We will continue executing against our core measures of
success with the goal of exiting the year as a leader in the medical
genetic testing markets, demonstrating the strength of our core strategy
and capabilities and showing a clear path to positive cash flow with the
continued success of our business model.”
Indicators of our Success in 2016
The four guiding indicators of success in 2016 include:
1. Reducing COGS per test.
2. Increasing content.
3. Increasing volume.
4. Improving reimbursement and cash collections.
Conference Call Details
The dial-in numbers for the conference call are (877) 201-0168 for
domestic callers and (647) 788-4901 for international callers, and the
reservation number for both is 92101487.
The live, listen-only webcast of the conference call may be accessed by
visiting the investors section of the company’s website at ir.invitae.com.
A replay of the webcast will be available shortly after the conclusion
of the call and will be archived on the company’s website.
About Invitae
Invitae Corporation's (NYSE: NVTA) mission is to bring comprehensive
genetic information into mainstream medical practice to improve the
quality of healthcare for billions of people. Invitae’s goal is to
aggregate most of the world’s genetic tests into a single service with
higher quality, faster turnaround time, and lower price than many
single-gene and panel tests today. The company currently provides a
diagnostic service comprising hundreds of genes for a variety of genetic
disorders associated with oncology, cardiology, neurology, pediatrics,
and other rare disease areas.
For more information, visit our website at ir.invitae.com
and follow us on Twitter: @invitae
and @invitaeIR.
Safe Harbor Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to the company’s belief that its
reimbursement history is the start of a major transition in the payer
industry to more affordable and accessible genetic testing; the timing
of its occupation of its new lab facility; the company’s expectations
that it will continue to increase the number of people it serves and
that it will be in a strong position to be the partner of choice for
inherited genetic testing and associated services; and the indicators of
the company’s success and its expected actions with respect to those
indicators. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially, and
reported results should not be considered as an indication of future
performance. These risks and uncertainties include, but are not limited
to: the company’s history of losses; the company’s need to scale its
infrastructure in advance of demand for its tests and to increase demand
for its tests; the company’s ability to develop and commercialize new
tests and expand into new markets; the risk that the company may not
obtain or maintain sufficient levels of reimbursement for its tests;
risks associated with the company’s ability to use rapidly changing
genetic data to interpret test results accurately and consistently; the
company’s ability to compete; laws and regulations applicable to the
company’s business, including potential regulation by the Food and Drug
Administration; and the other risks set forth in the company’s filings
with the Securities and Exchange Commission, including the risks set
forth in the company’s Annual Report on Form 10-K for the year ended
2015. These forward-looking statements speak only as of the date hereof,
and Invitae Corporation disclaims any obligation to update these
forward-looking statements.
NOTE: Invitae and the Invitae logo are trademarks of Invitae
Corporation. All other trademarks and service marks are the property of
their respective owners.
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Invitae Corporation
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
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Three months ended
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March 31,
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2016
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2015
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(Unaudited)
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(Unaudited)
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Revenue
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$
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3,955
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$
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1,229
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Costs and operating expenses:
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Cost of revenue
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5,987
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3,199
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Research and development
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10,660
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8,455
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Selling and marketing
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7,043
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4,740
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General and administrative
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5,569
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3,440
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Total costs and operating expenses
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29,259
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19,834
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Loss from operations
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(25,304)
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(18,605)
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Interest and other income (expense), net
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(202)
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(4)
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Interest expense
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(84)
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(28)
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Net loss
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$
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(25,590)
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$
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(18,637)
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Net loss per share, basic and diluted
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$
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(0.80)
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$
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(1.09)
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Shares used in computing net loss per share, basic and diluted
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31,964,541
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17,063,463
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Invitae Corporation
Condensed Consolidated Balance Sheets
(In thousands)
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March 31,
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December 31,
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2016
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2015
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(Unaudited)
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Assets
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Current assets:
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Cash and cash equivalents
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$
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27,314
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$
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73,238
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Marketable securities
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76,551
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53,780
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Prepaid expenses and other current assets
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10,853
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4,292
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Total current assets
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114,718
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131,310
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Property and equipment, net
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17,813
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18,709
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Restricted cash
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4,831
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4,831
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Other assets
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1,664
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1,826
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Total assets
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$
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139,026
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$
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156,676
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Liabilities, convertible preferred stock, and stockholders’
equity
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Current liabilities:
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Accounts payable
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$
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2,694
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$
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3,500
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Accrued liabilities
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4,241
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4,253
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Capital lease obligation, current portion
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1,529
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1,588
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Debt, current portion
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2,113
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1,536
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Total current liabilities
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10,577
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10,877
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Capital lease obligation, net of current portion
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1,231
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1,576
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Debt, net of current portion
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7,041
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5,504
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Other long term liabilities
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5,669
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343
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Total liabilities
|
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24,518
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18,300
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Stockholders’ equity:
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Common stock
|
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4
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4
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Accumulated other comprehensive gain (loss)
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28
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(15
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)
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Additional paid-in capital
|
|
|
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|
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|
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315,028
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|
|
|
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|
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313,349
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Accumulated deficit
|
|
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(200,552
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)
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(174,962
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)
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Total stockholders’ equity
|
|
|
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114,508
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|
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138,376
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Total liabilities, convertible preferred stock and stockholders’
equity
|
|
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$
|
139,026
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|
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$
|
156,676
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|
|
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The condensed, consolidated balance sheet at December 31, 2015 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, 2015.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160509006451/en/
Source: Invitae Corporation