-- Lives covered now at more than 160,000,000 --
-- Reduced COGS to $450 per sample, expects to be cash flow positive
by end of 2018 --
-- Hosting webinar/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 third quarter ended September 30, 2016. Year
to date, the company has secured contracts with the top five major
payers while making substantial progress on all four of its key metrics.
The company also stated it expects to be cash flow positive by the end
of 2018.
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20161107006497/en/
(Graphic: Invitae Corporation)
“We believe Invitae has emerged from being a concept story to a company
that has industry-leading growth rates in the genetic testing market
with a clear path to becoming cash flow positive,” said Randy Scott,
chairman and chief executive officer at Invitae. “With our recently
announced progress in contracting with the top five major payers, we are
now shifting our emphasis to driving revenue as a top priority. We will
be working diligently to begin to operationalize those contracts as we
move in network which should significantly improve our payment rates and
drive volume growth throughout 2017 and beyond.”
The company reported total revenue of $6.3 million in the third quarter
of 2016, compared to $2.2 million in the third quarter of 2015. Total
costs and operating expenses were $31.2 million in the third quarter of
2016 compared to $24.6 million for the third quarter of 2015. Cost of
revenue (cost of tests delivered) was $7.2 million for approximately
15,500 samples accessioned in the third quarter of 2016 compared to $4.0
million for more than 5,400 samples accessioned in the third quarter of
2015. Operating expenses, excluding cost of revenue (cost of tests
delivered), were $23.9 million in the third quarter of 2016 compared to
$20.7 million for the third quarter of 2015. Net loss was $25.0 million
in the third quarter of 2016, or a $0.77 loss per share, compared to
$22.5 million in the third quarter of 2015, or a $0.71 loss per share.
Operating expenses in the third quarter of 2016 included non-cash
expenses of approximately $5.3 million, including depreciation, equity
compensation, and non-cash rent expense for a new production facility,
which the company expects to occupy later this year.
At September 30, 2016, cash, cash equivalents, restricted cash, and
marketable securities totaled approximately $71.4 million, approximately
$18.8 million less than the comparable amount as of June 30, 2016.
“This quarter represents a turning point for us as we believe we have
substantially reduced the technical, market, and execution risk against
our business plan and have a runway to ramp our revenue and create a
profitable long-term business,” said Sean George, president and chief
operating officer at Invitae. “Over the past two years, you’ve seen us
emerge from a concept – bringing genetics into mainstream medicine –
into a rapidly growing business with a clear path to positive cash flow.”
The following are recent highlights:
-
Increased volume: Increased volume by 200% year-over-year and
25% quarter-over-quarter by delivering approximately 15,200 billable
reports and accessioning approximately 15,500 samples.
-
Lowered COGS: Reduced cost of goods sold per sample accessioned
(COGS) from approximately $500 in the second quarter of 2016 to
approximately $450 in the third quarter of 2016.
-
Expanded content: Introduced expanded neurology and cardiology
test offerings, including new panels for Parkinson’s disease,
neuropathies, neuromuscular diseases, and a cardiomyopathy and
skeletal muscle disease panel, and added new genes to panels for
arrhythmias, cardiomyopathies, aortopathies, and congenital heart
disease.
-
Improved reimbursement: Established reimbursement with the top
five national payers, bringing total lives covered to more than 160
million, up from approximately 95 million in the second quarter of
2016. In addition, announced Medicare and Medicaid Services’ (CMS)
final pricing of $925 for genetic testing for hereditary breast
cancer-related disorders (e.g. hereditary breast cancer, hereditary
ovarian cancer, and hereditary endometrial cancer).
-
Secured new collaborator for Invitae’s Genome Network:
Announced a collaboration with Helix to build some of the first
proactive health apps for healthy individuals in the Helix marketplace
for common, actionable inherited disorders for which there are
preventive measures available. The collaboration will initially focus
on common, actionable genes associated with inherited forms of cancer
and cardiovascular disease, with plans to offer additional
applications in the future. This adds to Invitae’s growing network of
biopharma, platform, researcher, and patient advocacy collaborators.
-
Contributed data on an array of topics in genetics: Presented
multiple abstracts at medical meetings:
-
Highlighted new research on genetic testing for preventive care
and new strategies for providing remote access to genetic
counseling services at the National Society of Genetic Counselors
(NSGC) 35th Annual Education Conference, including the following
abstracts:
-
Creating a medically actionable genetic screening panel for
healthy individuals (Presentation #D12-1377)
-
A novel approach to lab-based clinical genetic counseling
(Presentation #C04-1030)
-
Inherited cardiomyopathies in the pediatric population – what
molecular testing reveals (Poster #A-142)
-
Presented data at The American Society of Human Genetics (ASHG)
2016 Annual meeting, including the following abstracts:
Webinar and Conference Call Details
Management will host a webinar and conference call at 4:45 pm ET / 1:45
pm PT. 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 5259406.
The live 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 invitae.com.
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 beliefs regarding its
positioning in the market; the company’s expectations regarding being
cash flow positive; future performance levels; the indicators of the
company’s success and its expected actions with respect to those
indicators; the company’s belief that it has industry-leading market
share and growth rates; the company’s prioritization of driving revenue;
the company’s expectation that it will begin to operationalize contracts
with major payers, and that payment rates and volume will increase
throughout 2017 and beyond; the company’s belief that it has
substantially reduced risk, and has a runway to ramp revenue and create
a profitable long-term business; the ultimate functionality, features,
availability and processes used by the Invitae apps and the Helix
marketplace; and the company’s beliefs with respect to the benefits of
the Invitae apps and the Helix marketplace. 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: risks associated with the company’s
ability to develop and commercialize new tests and expand into new
markets; the company’s ability to use rapidly changing genetic data to
interpret test results accurately, consistently and quickly; the
company’s history of losses; the company’s need to scale its
infrastructure in advance of demand for its tests and its ability to
increase demand for its tests; the company’s ability to drive revenue as
a top priority; the company’s ability to successfully operationalize
payer contracts; the company’s ability to achieve and maintain positive
cash flows and to execute its strategy to create a profitable long term
business; the risk that the company may not obtain or maintain
sufficient levels of reimbursement for its tests; laws and regulations
applicable to the company’s business, including potential regulation by
the Food and Drug Administration; that Medicare may change the pricing
or other terms for reimbursement, or not reimburse the company for other
tests in the future; the risk that the company’s apps on the Helix
platform are not ultimately launched; 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, 2016. 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,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
(unaudited)
|
|
Revenue
|
|
$
|
6,276
|
|
|
$
|
2,187
|
|
|
$
|
15,812
|
|
|
$
|
5,217
|
|
|
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
7,242
|
|
|
|
3,952
|
|
|
|
19,705
|
|
|
|
11,017
|
|
|
Research and development
|
|
|
11,482
|
|
|
|
11,134
|
|
|
|
32,855
|
|
|
|
31,426
|
|
|
Selling and marketing
|
|
|
6,803
|
|
|
|
5,439
|
|
|
|
20,689
|
|
|
|
16,368
|
|
|
General and administrative
|
|
|
5,655
|
|
|
|
4,118
|
|
|
|
17,794
|
|
|
|
11,592
|
|
|
Total costs and operating expenses
|
|
|
31,182
|
|
|
|
24,643
|
|
|
|
91,043
|
|
|
|
70,403
|
|
|
Loss from operations
|
|
|
(24,906
|
)
|
|
|
(22,456
|
)
|
|
|
(75,231
|
)
|
|
|
(65,186
|
)
|
|
Other income (expense), net
|
|
|
50
|
|
|
|
(9
|
)
|
|
|
122
|
|
|
|
(111
|
)
|
|
Interest expense
|
|
|
(115
|
)
|
|
|
(62
|
)
|
|
|
(299
|
)
|
|
|
(125
|
)
|
|
Net loss
|
|
$
|
(24,971
|
)
|
|
$
|
(22,527
|
)
|
|
$
|
(75,408
|
)
|
|
$
|
(65,422
|
)
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.77
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(2.35
|
)
|
|
$
|
(2.43
|
)
|
|
Shares used in computing net loss per share, basic and diluted
|
|
|
32,315,038
|
|
|
|
31,852,796
|
|
|
|
32,145,806
|
|
|
|
26,962,821
|
|
|
|
|
Invitae Corporation
|
|
Condensed Consolidated Balance Sheets
|
|
(In thousands)
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
37,745
|
|
|
$
|
73,238
|
|
|
Marketable securities
|
|
|
29,003
|
|
|
|
53,780
|
|
|
Prepaid expenses and other current assets
|
|
|
8,216
|
|
|
|
4,292
|
|
|
Total current assets
|
|
|
74,964
|
|
|
|
131,310
|
|
|
Property and equipment, net
|
|
|
21,226
|
|
|
|
18,709
|
|
|
Restricted cash
|
|
|
4,697
|
|
|
|
4,831
|
|
|
Other assets
|
|
|
811
|
|
|
|
1,826
|
|
|
Total assets
|
|
$
|
101,698
|
|
|
$
|
156,676
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,204
|
|
|
$
|
3,500
|
|
|
Accrued liabilities
|
|
|
6,350
|
|
|
|
4,253
|
|
|
Capital lease obligation, current portion
|
|
|
1,383
|
|
|
|
1,588
|
|
|
Debt, current portion
|
|
|
3,377
|
|
|
|
1,536
|
|
|
Total current liabilities
|
|
|
13,314
|
|
|
|
10,877
|
|
|
Capital lease obligation, net of current portion
|
|
|
592
|
|
|
|
1,576
|
|
|
Debt, net of current portion
|
|
|
9,568
|
|
|
|
5,504
|
|
|
Other long-term liabilities
|
|
|
7,380
|
|
|
|
343
|
|
|
Total liabilities
|
|
|
30,854
|
|
|
|
18,300
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
Common stock
|
|
|
4
|
|
|
|
4
|
|
|
Accumulated other comprehensive gain (loss)
|
|
|
18
|
|
|
|
(15
|
)
|
|
Additional paid-in capital
|
|
|
321,192
|
|
|
|
313,349
|
|
|
Accumulated deficit
|
|
|
(250,370
|
)
|
|
|
(174,962
|
)
|
|
Total stockholders’ equity
|
|
|
70,844
|
|
|
|
138,376
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
101,698
|
|
|
$
|
156,676
|
|
|
|
|
|
|
|
|
|
|
|
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.
Source: Invitae Corporation
View source version on businesswire.com: http://www.businesswire.com/news/home/20161107006497/en/
Source: Invitae Corporation