– Accelerated development of a 20,000-gene medical exome to be
available in Q1:2017 –
– Nearly tripled volume with more than 12,000 test reports delivered –
– Lowered COGS to approximately $500 –
– Signed first biopharma agreements –
– 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 second quarter ended June 30, 2016. The
company made substantial progress on all four of its key metrics,
including securing contracts with a major national payer and adding more
regional private plans. The company also announced it is accelerating
the development of its medical exome, to be comprised of more than
20,000 genes, which it expects will be available in the first quarter of
2017.
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20160808006131/en/
“Today we are announcing that we will be ‘leapfrogging’ our year-end
goal of 3,000 genes in production by jumping to approximately 20,000
genes with a ‘boosted’ exome. Combined with our large and growing panel
offerings we believe we will be able to provide the full spectrum of
content for virtually every current clinical need,” said Randy Scott,
chairman and CEO of Invitae. “We’ve made significant progress with
Medicare and a national private payer now on board and more private
payers to come in the near future. We believe the reimbursement tide is
turning rapidly as payers adopt our low cost platform and begin to
eliminate the high gross margins that have restrained market growth and
patient access to genetic testing.”
Total revenue was $5.6 million for the second quarter of 2016, compared
to $4.0 million in the first quarter of 2016. Operating expenses,
excluding the costs of tests delivered, were $23.2 million compared to
$23.3 million for the first quarter of 2016. Costs of tests delivered
were $6.5 million for the second quarter of 2016 compared to $6.0
million in the first quarter of 2016.
The company reported total revenue of $5.6 million in the second quarter
of 2016, compared to $1.8 million in the second quarter of 2015.
Operating expenses, excluding the costs of tests delivered, were $23.2
million compared to $22.1 million for the second quarter of 2015. Costs
of tests delivered were $6.5 million for more than 12,500 samples
accessioned in the second quarter of 2016 compared to $3.9 million for
more than 4,600 samples accessioned in the second quarter of 2015. Net
loss was $24.8 million in the second quarter of 2016, or a $0.77 loss
per share. Operating expenses in the second quarter of 2016 included
non-cash expenses of approximately $5.2 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 June 30, 2016, cash, cash equivalents, restricted cash, and
marketable securities totaled approximately $90.2 million, approximately
$18.5 million less than the comparable amount as of March 31, 2016.
Following are recent highlights:
-
Increased volume: Increased volume by 170% year-over-year by
delivering more than 12,000 billable reports and accessioning more
than 12,500 samples. Also announced that the company completed the
comprehensive Clinical Laboratory Evaluation Program and received its
clinical laboratory permit from the state of New York, and is now
offering testing for hereditary cancer, cardiology, and pediatric
patients.
-
Lowered COGS: Reduced cost of goods sold (COGS) from
approximately $600 in the first quarter of 2016 to approximately $500
per sample accessioned in the second quarter.
-
Expanded content:
-
Announced it has accelerated development of its medical exome,
which will be comprised of more than 20,000 genes, including 3,000
clinically important genes with “boosted” sequence coverage, and
is expected to be available in the first quarter of 2017.
-
Continued to expand its menu to strengthen its cancer offering
with a seven-gene Breast
Cancer STAT Panel for patients who need rapid test results to
guide surgical decisions and treatment options.
-
Improved reimbursement: Established reimbursement with several
payers, including Aetna and Medicare, bringing total lives covered to
approximately 95 million:
-
Signed an agreement on July 1, 2016 to become part of Aetna’s
(NYSE: AET) laboratory network, effective August 15, 2016.
-
Secured contracts with other regional Blue Cross Blue Shield
affiliates, including Blue Shield of California as a preferred
in-network laboratory for hereditary breast and ovarian cancer
(HBOC) and Lynch syndrome testing, as well as Blue Cross Blue
Shield of Illinois, Blue Cross Blue Shield of Rhode Island,
Wellmark (Iowa and South Dakota), as well as other private payers.
-
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. Payments are made by Noridian, CMS’s administrative
contractor for California.
-
Signed additional contracts with institutional customers,
increasing its total number of active institutional customers to
more than 100 accounts worldwide.
-
Improved competitive advantage with our oncology offering: In
addition to the seven-gene Breast
Cancer STAT Panel for patients who need rapid test results to
guide surgical decisions and treatment options, Invitae:
-
Launched CancerCHECK,
a tool designed to guide and support community oncologists to more
easily follow clinical guidelines on the use of hereditary cancer
genetic testing.
-
Highlighted data at the 2016 American Society of Clinical Oncology
Annual meetings, including:
-
Beginning to build genome network: Signed contracts and began
working with pharmaceutical and biotech companies, including
MyoKardia, Parion Sciences, and others to provide genetic testing
for clinical trial and other programs to help connect patients to
potential treatments.
-
Commitment to data sharing: Submitted information on more
than 10,000 clinically observed genetic variants to the ClinVar
project, an effort by the National
Center for Biotechnology Information (NCBI) to aggregate all
of the world’s known relationships between genetic variants and
disease, bringing our total submissions to more than 22,000.
“We have executed consistently on all business measures over the last
seven quarters, our business model is indeed working, and we are seeing
the operating leverage that we expect will soon move us to positive
gross margins and subsequently drive us toward positive cash flow
generation. We continued to maintain operating effectiveness as we scale
through almost tripled year-over-year sample volume growth. In fact, our
turnaround times continue to improve as we grow volume to the
50,000-70,000 samples we projected for the year,” said Sean George,
president and COO of Invitae. “Now with payers and other industry
partners working with us, we are increasing our commercial leverage and
can accelerate driving the change in the genetic testing landscape to an
industry in which we believe we are well-positioned to be the leader.”
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
Webinar and 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 48736029.
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 expectations regarding
its ability to obtain reimbursement; the company’s beliefs regarding its
positioning in the market; the company’s accelerated development of its
medical exome to be comprised of more than 20,000 genes and its belief
that it will be available in the first quarter of 2017; the company’s
expectation that it will occupy its new production facility later this
year; the company’s expectations regarding being cash flow positive;
future performance levels; 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: 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 to
increase demand for its tests; 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; 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 March 31, 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.
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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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Six months ended
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June 30,
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June 30,
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2016
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2015
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2016
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2015
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(unaudited)
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Revenue
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$
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5,581
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$
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1,801
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$
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9,536
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|
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$
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3,030
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Costs and operating expenses:
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Cost of revenue
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6,476
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3,866
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12,463
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7,065
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Research and development
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10,713
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11,837
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21,373
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|
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|
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20,292
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Selling and marketing
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6,843
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6,189
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13,886
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10,929
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General and administrative
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5,637
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4,034
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11,206
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|
|
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|
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7,474
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Total costs and operating expenses
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29,669
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|
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25,926
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|
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58,928
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|
|
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45,760
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Loss from operations
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(24,088
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)
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(24,125
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)
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(49,392
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)
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(42,730
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)
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Interest and other income (expense), net
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(659
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)
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(98
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)
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(861
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)
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(102
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)
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Interest expense
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(100
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)
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(35
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)
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(184
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)
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(63
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)
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Net loss
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$
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(24,847
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)
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|
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$
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(24,258
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)
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|
|
|
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$
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(50,437
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)
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|
|
|
$
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(42,895
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)
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Net loss per share, basic and diluted
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$
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(0.77
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)
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$
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(0.76
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)
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$
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(1.57
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)
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|
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$
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(1.75
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)
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Shares used in computing net loss per share, basic and diluted
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32,154,982
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31,809,683
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32,060,260
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24,477,309
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Invitae Corporation
Condensed Consolidated Balance Sheets
(In thousands)
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June 30,
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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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31,587
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$
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73,238
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Marketable securities
|
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53,699
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53,780
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Prepaid expenses and other current assets
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11,465
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4,292
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Total current assets
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96,751
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131,310
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Property and equipment, net
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18,708
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18,709
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Restricted cash
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4,872
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4,831
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Other assets
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862
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|
|
|
|
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1,826
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Total assets
|
|
|
|
|
$
|
121,193
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|
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$
|
156,676
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Liabilities and stockholders’ equity
|
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Current liabilities:
|
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|
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|
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Accounts payable
|
|
|
|
|
$
|
3,899
|
|
|
|
|
|
|
$
|
3,500
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|
Accrued liabilities
|
|
|
|
|
|
4,187
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|
|
|
|
|
|
|
4,253
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Capital lease obligation, current portion
|
|
|
|
|
|
1,456
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|
|
|
|
|
|
|
1,588
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Debt, current portion
|
|
|
|
|
|
2,725
|
|
|
|
|
|
|
|
1,536
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Total current liabilities
|
|
|
|
|
|
12,267
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|
|
|
|
|
|
|
10,877
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Capital lease obligation, net of current portion
|
|
|
|
|
|
913
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|
|
|
|
|
|
1,576
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Debt, net of current portion
|
|
|
|
|
|
8,400
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|
|
|
|
|
|
|
5,504
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Other long-term liabilities
|
|
|
|
|
|
6,920
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|
|
|
|
|
|
|
343
|
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Total liabilities
|
|
|
|
|
|
28,500
|
|
|
|
|
|
|
|
18,300
|
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Stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
|
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Common stock
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
4
|
|
Accumulated other comprehensive gain (loss)
|
|
|
|
|
|
32
|
|
|
|
|
|
|
|
(15
|
)
|
Additional paid-in capital
|
|
|
|
|
|
318,056
|
|
|
|
|
|
|
|
313,349
|
|
Accumulated deficit
|
|
|
|
|
|
(225,399
|
)
|
|
|
|
|
|
|
(174,962
|
)
|
Total stockholders’ equity
|
|
|
|
|
|
92,693
|
|
|
|
|
|
|
|
138,376
|
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Total liabilities and stockholders’ equity
|
|
|
|
|
$
|
121,193
|
|
|
|
|
|
|
$
|
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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160808006131/en/
Source: Invitae Corporation