-- Expands test menu with more than 600 genes in production and
raises 2015 guidance to 17,000-19,000 billable tests delivered for the
year --
-- Hosting conference call at 4:45 pm ET / 1:45 pm PT --
SAN FRANCISCO--(BUSINESS WIRE)--
Invitae
Corporation (NYSE:
NVTA) today reported financial and operating results for the third
quarter ended September 30, 2015. The company has raised its 2015
guidance for billable tests delivered to 17,000-19,000 for the year, up
from its previous guidance of 16,000-18,000 billable tests delivered.
“Two years after the Supreme Court decision, we are helping to usher in
a bold new landscape for hereditary testing that is based on making high
quality genetics more affordable and more accessible to the mainstream
medical community,” said Randy Scott, chairman and CEO of Invitae. “In
the multi-billion dollar genetics industry, we are beginning to prove
that providing high-quality content with low prices can help clinicians
better serve their patients. This innovative positioning has led us to
market share growth that we believe is also one of the fastest in the
industry.”
Following are recent highlights:
-
Generated revenue of nearly $2.2 million in the third quarter of 2015.
-
Increased volume by delivering more than 5,100 billable reports, an
increase of more than 360% from the year prior, and accessioned more
than 5,400 samples.
-
Reduced cost of goods sold (COGS) from less than $850 to less than
$750 per sample accessioned for the quarter, while increasing the
production and medical teams in anticipation of additional content and
volume.
-
More than doubled the size of its genetic testing platform to include
more than 600 genes and began releasing new content in October at the
American Society of Human Genetics 2015 annual meeting, with dozens of
new test panels for hereditary cancer, cardiovascular, neuromuscular,
pediatric, and other rare disorders, specifically:
-
Comprehensive cancer testing: more than 40 test panels, comprised
of more than 70 carefully curated genes. The Invitae hereditary
cancer menu consists of a mix of broader tests and smaller focused
panels. The new offering includes a new common hereditary cancers
panel and a gastric cancer panel, as well as expanded breast,
gynecologic, colon, and pancreatic cancer panels. Before the end
of the year, Invitae plans to further expand its cancer offering
to include all hereditary cancers, including blood, bone, brain,
endocrine, genitourinary, and skin cancers, as well as sarcomas.
-
Comprehensive cardiovascular testing: more than 30 test panels,
representing more than 190 carefully curated genes. The new test
menu includes large combination panels for multiple conditions,
including arrhythmias, cardiomyopathies, aortopathies, familial
hypercholesterolemia, pulmonary hypertension, and congenital heart
disease.
-
Expanded neuromuscular testing: 15 major test panels, comprised of
nearly 100 carefully curated genes for disorders including
Duchenne/Becker muscular dystrophy, dystonia, Charcot-Marie-Tooth
disease, and hereditary spastic paraplegia.
-
Expanded pediatric and rare disorder testing: more than 40 test
panels, comprised of more than 140 carefully curated genes, for
disorders including RASopathies and primary ciliary dyskinesia
(PCD). Invitae also continues to offer testing for
hematology-related disorders, including hereditary hemochromatosis
and hereditary thrombophilia.
-
Signed additional contracts with institutions and payers, including
Tufts Health Plan.
-
Published clinical data in JAMA Oncology from a study of more than
1,000 patients who were tested with multi-gene panels. The clinical
actions that would be considered were reviewed for all 63 patients
testing positive for cancer genes other than BRCA1 or BRCA2. For more
than half of these patients, the genetic test would suggest a change
in care over and above any recommendations based on the patient’s
personal and family history alone. For these patients’ family members,
testing would be warranted, as over 70% would have a change in care
considered if also found to be mutation positive.
“We have driven down the cost of goods by 43% since the third quarter of
2014, we’ve more than doubled our content, our volume continues to grow
rapidly with year-over-year growth of more than 360%, and we’ve added
new payer contracts,” said Sean George, president and chief operating
officer of Invitae. “2015 has been a year of significant investment in
our infrastructure, and we are increasingly confident that our
investments will continue to pay off in 2016 and beyond, both in terms
of market share and financial progress.”
The company reported total revenue of $2.2 million in the third quarter
of 2015, compared to $0.3 million in the third quarter of 2014. Total
operating expenses for the third quarter of 2015 were $24.6 million,
compared with $12.8 million for the third quarter of 2014. Net loss was
$22.5 million in the third quarter of 2015, or a $0.71 loss per share.
At September 30, 2015, cash, cash equivalents, restricted cash, and
marketable securities totaled approximately $152.1 million.
Indicators of our success in 2015
The four guiding indicators of success in 2015 include:
1. Reducing COGS per test.
2. Increasing content.
3.
Increasing volume.
4. Improving reimbursement and cash collections.
Conference call details
Invitae will host a live conference call and webcast today at 4:45
p.m. Eastern / 1:45 p.m. Pacific to discuss financial results and recent
developments.
The dial-in numbers for the conference call are (866) 393-4306 for
domestic callers and (734) 385-2616 for international callers, and the
reservation number for both is 61246482.
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
diagnostic services 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 www.invitae.com
and follow us on Twitter: @invitae.
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 it can
accelerate the adoption of comprehensive genetic information into
mainstream medical care and realize its mission; the company’s
expectations regarding the range of billable tests delivered in 2015;
the company’s expectations regarding future returns on its investments
in terms of market share and financial progress; the company’s market
share and market share growth; the timing of any new testing service
releases and the attributes of any such services; the company’s beliefs
regarding the benefits of its pricing program; the attributes and
benefits of the company’s tests to patients, physicians and payers ; 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 Quarterly Report on Form 10-Q for
the quarter ended June 30, 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.
|
Invitae Corporation
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
(unaudited)
|
Revenue
|
|
$
|
2,187
|
|
|
$
|
310
|
|
|
$
|
5,217
|
|
|
$
|
729
|
|
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
3,952
|
|
|
|
1,689
|
|
|
|
11,017
|
|
|
|
3,263
|
|
Research and development
|
|
|
11,134
|
|
|
|
5,557
|
|
|
|
31,426
|
|
|
|
15,600
|
|
Selling and marketing
|
|
|
5,439
|
|
|
|
2,386
|
|
|
|
16,368
|
|
|
|
5,823
|
|
General and administrative
|
|
|
4,118
|
|
|
|
3,212
|
|
|
|
11,592
|
|
|
|
8,112
|
|
Total costs and operating expenses
|
|
|
24,643
|
|
|
|
12,844
|
|
|
|
70,403
|
|
|
|
32,798
|
|
Loss from operations
|
|
|
(22,456
|
)
|
|
|
(12,534
|
)
|
|
|
(65,186
|
)
|
|
|
(32,069
|
)
|
Interest and other income (expense), net
|
|
|
(9
|
)
|
|
|
(66
|
)
|
|
|
(111
|
)
|
|
|
(69
|
)
|
Interest expense
|
|
|
(62
|
)
|
|
|
(15
|
)
|
|
|
(125
|
)
|
|
|
(49
|
)
|
Net loss
|
|
$
|
(22,527
|
)
|
|
$
|
(12,615
|
)
|
|
$
|
(65,422
|
)
|
|
$
|
(32,187
|
)
|
Net loss per share basic and diluted
|
|
$
|
(0.71
|
)
|
|
$
|
(14.24
|
)
|
|
$
|
(2.43
|
)
|
|
$
|
(39.27
|
)
|
Shares used in computing net loss per share basic and diluted
|
|
|
31,852,796
|
|
|
|
885,999
|
|
|
|
26,962,821
|
|
|
|
819,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Invitae Corporation
Condensed Consolidated Balance Sheets
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
September 30
|
|
|
December 31
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
(unaudited)
|
|
|
|
Assets
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
48,999
|
|
|
$
|
107,027
|
|
Prepaid expenses and other current assets
|
|
|
3,267
|
|
|
|
2,616
|
|
Marketable securities
|
|
|
98,253
|
|
|
|
—
|
|
Total current assets
|
|
|
150,519
|
|
|
|
109,643
|
|
Property and equipment, net
|
|
|
18,652
|
|
|
|
15,672
|
|
Restricted cash
|
|
|
4,847
|
|
|
|
150
|
|
Other assets
|
|
|
1,654
|
|
|
|
3,313
|
|
Total assets
|
|
$
|
175,672
|
|
|
$
|
128,778
|
|
Liabilities and Stockholders’ Deficit
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,420
|
|
|
$
|
2,862
|
|
Accrued liabilities
|
|
|
3,376
|
|
|
|
3,237
|
|
Capital lease obligation, current portion
|
|
|
1,670
|
|
|
|
1,524
|
|
Debt, current portion
|
|
|
991
|
|
|
|
—
|
|
Total current liabilities
|
|
|
8,457
|
|
|
|
7,623
|
|
Capital lease obligation, net of current portion
|
|
|
1,976
|
|
|
|
2,011
|
|
Debt, net of current portion
|
|
|
3,797
|
|
|
|
—
|
|
Other long term liabilities
|
|
|
335
|
|
|
|
401
|
|
Liabilities related to early exercise of stock options
|
|
|
6
|
|
|
|
14
|
|
Total liabilities
|
|
|
14,571
|
|
|
|
10,049
|
|
Convertible preferred stock
|
|
|
—
|
|
|
|
202,305
|
|
Stockholders’ (deficit):
|
|
|
|
|
|
|
Common stock
|
|
|
4
|
|
|
|
—
|
|
Accumulated other comprehensive income
|
|
|
11
|
|
|
|
—
|
|
Additional paid-in capital
|
|
|
311,688
|
|
|
|
1,604
|
|
Accumulated deficit
|
|
|
(150,602
|
)
|
|
|
(85,180
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit)
|
|
|
161,101
|
|
|
|
(83,576
|
)
|
Total liabilities, convertible preferred stock and stockholders’
equity (deficit)
|
|
$
|
175,672
|
|
|
$
|
128,778
|
|
|
|
|
|
|
|
|
|
|
The condensed, consolidated balance sheet at December 31, 2014 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, 2014.
Source: Invitae Corporation

View source version on businesswire.com: http://www.businesswire.com/
Source: Invitae Corporation