REDWOOD CITY, Calif.,
May 4, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter ended
March 31, 2016.
Revenue was $80.9 million in the
first quarter of 2016, compared with $68.2
million in the first quarter of 2015, an increase of 19
percent.
U.S. revenue was $70.5 million in
the first quarter of 2016, an increase of 22 percent, compared with
the same period in the prior year. Prostate test revenue in
the U.S. of $2.6 million contributed
to approximately 4 percent of the year-over-year growth.
International revenue was $10.4
million in the first quarter of 2016, compared with
$10.4 million a year ago.
International revenue on a constant currency basis increased by 2
percent compared with a year ago.
More than 29,510 Oncotype DX® test results were
delivered in the first quarter of 2016, an increase of 16 percent,
compared with more than 25,430 test results delivered in 2015. U.S.
invasive breast tests delivered grew 11 percent and prostate tests
delivered grew 18 percent compared with the prior year.
International tests delivered grew 33 percent compared with the
prior year and represented approximately 22 percent of total test
volume in the first quarter of 2016.
"We delivered an exceptional quarter with 19 percent revenue
growth, including 22 percent revenue growth in our U.S. business
and 16 percent test growth worldwide, supporting our expectation to
deliver double-digit test and revenue growth this year," said Kim
Popovits, Chairman of the Board, Chief Executive Officer and
President of Genomic Health. "Additionally, we are completing
analytical validation of our first liquid biopsy test and remain on
track to expand our Oncotype IQ™ portfolio with the launch of
Oncotype SEQ™ in mid-2016."
Operating loss for the first quarter of 2016 was $8.8 million, compared with $14.7 million for the first quarter of 2015. Net
loss was $6.4 million for the first
quarter of 2016 and includes a realized gain and tax benefit in the
quarter from the company's investment in a marketable security
totaling $2.4 million. Basic and
diluted net loss per share was $0.19
for the first quarter of 2016, compared with basic and diluted net
loss per share of $0.30 for the same
period in 2015.
Cash and cash equivalents and short-term investments at
March 31, 2016 were $67.4 million excluding the fair value of the
company's investment in a marketable security of $18.9 million, compared with $76.8 million at December
31, 2015.
Recent Business Highlights
Oncotype DX Commercial Progress
- Established multiple private coverage arrangements for the
Oncotype DX Genomic Prostate Score™, bringing the total number of
prostate cancer covered U.S. lives to approximately 60
million.
- Expanded coverage of the Oncotype DX Breast Recurrence
Score® for patients with 1-3 positive nodes to include
13.8 million additional lives through expanded medical policies,
bringing the total number of node-positive covered U.S. lives to
more than 175 million.
- The French Ministry of Health announced an access program for
genomic tests, including Oncotype DX, for qualified patients with
early-stage invasive breast cancer in public and private centers
throughout France. This
reimbursement will be funded through a research budget provided by
the Ministry of Health and dedicated to cover innovative
diagnostics, specifically breast cancer gene expression tests.
- The German Association of Gynecological Oncology's (AGO's)
treatment guidelines were updated to recognize Oncotype DX as the
only multi-gene breast cancer test with 1A evidence, the highest
level. The AGO guidelines also reconfirmed Oncotype DX as the only
multi-gene expression test validated to provide predictive
information on the likelihood of chemotherapy benefit for women
with early-stage, hormone-receptor positive, HER2-negative invasive
breast cancer.
Pipeline, Presentations and Publications
- In March, the Journal of Clinical
Oncology published three-year clinical outcome results
from the PlanB study led by the West German Study Group (WSG),
which demonstrated that women with Oncotype DX Recurrence Score
results of 11 or less had excellent outcomes with 98 percent
disease-free survival rates at three years, despite having
high-risk disease by traditional parameters. Additionally, the WSG
investigators presented positive five-year PlanB clinical outcome
results in a plenary oral presentation at the 10th
European Breast Cancer Conference in Amsterdam.
- Results from three international Oncotype DX decision impact
studies were recently published demonstrating that physicians in
the UK, Turkey and Hong Kong changed treatment recommendations in
up to 49 percent of cases, resulting in an overall reduction in the
recommended use of chemotherapy.
- Presented or received acceptance to present Oncotype DX Genomic
Prostate Score data at each major Urological meeting this past year
including the European Association of Urology Congress, the Society
of Urological Oncology, the American Society of Clinical Oncology
(ASCO) GU Cancers Symposium and the American Urological Association
Annual Meeting. This growing body of evidence continues to
reinforce the value of the Genomic Prostate Score in providing
additional information on the biologic risk of aggressive disease
beyond traditional factors.
- Received acceptance to present seven abstracts at the upcoming
ASCO Annual Meeting June 3-7,
including studies in breast and prostate cancer.
Conference Call Details
To access the live conference
call today, May 4, at 4:30 p.m. Eastern Time via phone, please dial
(877) 303-7208 from the United
States and Canada or +1
(224) 357-2389 internationally. The conference ID is 92699767.
Please dial in approximately ten minutes prior to the start of the
call. To access the live and subsequently archived webcast of the
conference call, go to the Investor Relations section of the
company's website at http://investor.genomichealth.com/events.cfm.
Please connect to the web site at least 15 minutes prior to the
call to allow for any software download that may be necessary.
About Genomic Health
Genomic Health, Inc. (NASDAQ:
GHDX) is the world's leading provider of genomic-based diagnostic
tests that address both the overtreatment and optimal treatment of
cancer, one of the greatest issues in healthcare today. With its
Oncotype IQ™ Genomic Intelligence Platform, the company is applying
its world-class scientific and commercial expertise and
infrastructure to lead the translation of clinical and genomic big
data into actionable results for treatment planning throughout
the cancer patient journey, from diagnosis to treatment selection
and monitoring. The Oncotype IQ portfolio of genomic tests and
services currently consists of the company's flagship line of
Oncotype DX gene expression tests that have been used to guide
treatment decisions for more than 600,000 cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid and tissue-based tests. The company is
based in Redwood City, California, with
international headquarters in Geneva, Switzerland. For
more information, please visit, www.GenomicHealth.com and
follow the company on Twitter:
@GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating the company's beliefs regarding
its liquid biopsy platform and the timing of a liquid biopsy test;
the company's intent to continue investing in its current product
lines in the U.S. and international markets; the attributes and
focus of the company's product pipeline; the ability of any
potential tests the company may develop to optimize cancer
treatment; and the ability of the company to develop and
commercialize additional tests in the future. 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 risks
and uncertainties associated with the regulation of the company's
tests; the results of clinical studies and their impact on
reimbursement and adoption; the applicability of clinical study
results to actual outcomes; the company's ability to develop and
commercialize new tests and expand into new markets domestically
and internationally; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; the company's ability to obtain capital
when needed 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 December 31, 2015. These
forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these
forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX,
Recurrence Score, DCIS Score, Oncotype SEQ, and Oncotype IQ are
trademarks or registered trademarks of Genomic Health, Inc. All
other trademarks and service marks are the property of their
respective owners.
GENOMIC
HEALTH, INC.
Condensed
Consolidated Statements of Operations
(In thousands,
except per share amounts)
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2016
|
|
2015
|
|
|
|
(Unaudited)
|
|
REVENUES:
|
|
|
|
|
|
Product revenues –
United States
|
|
$
|
70,495
|
|
$
|
57,717
|
|
Product revenues –
Outside of the United States
|
|
|
10,399
|
|
|
10,435
|
|
Total
revenues
|
|
|
80,894
|
|
|
68,152
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1):
|
|
|
|
|
|
Cost of product
revenues
|
|
15,800
|
|
12,762
|
|
Research and
development
|
|
15,963
|
|
19,118
|
|
Selling and
marketing
|
|
39,500
|
|
35,352
|
|
General and
administrative
|
|
18,438
|
|
15,589
|
|
Total operating
expenses
|
|
89,701
|
|
82,821
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(8,807)
|
|
(14,669)
|
|
|
|
|
|
|
|
Interest
income
|
|
78
|
|
54
|
|
Gain on sales of
marketable securities
|
|
1,333
|
|
—
|
|
Other income
(expense), net
|
|
87
|
|
(374)
|
|
Loss before income
taxes
|
|
(7,309)
|
|
(14,989)
|
|
|
|
|
|
|
|
Income tax expense
(benefit)
|
|
(958)
|
|
(5,496)
|
|
Net loss
|
|
$
|
(6,351)
|
|
$
|
(9,493)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.19)
|
|
$
|
(0.30)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
32,900
|
|
32,055
|
|
|
|
|
|
|
|
|
(1)
|
Included in operating
expenses for the first quarter of 2016 were non-cash charges of
$6.7 million, including $4.5 million of stock-based compensation
expense and $2.2 million of depreciation and amortization expenses,
compared with non-cash charges for the same period in 2015 of $5.9
million, including $4.2 million of stock-based compensation expense
and $1.7 million of depreciation and amortization
expenses.
|
GENOMIC
HEALTH, INC.
Condensed
Consolidated Balance Sheets
(In
thousands)
|
|
|
|
|
|
|
|
|
As
of
March 31,
2016
|
|
As of
December 31,
2015
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
30,705
|
|
$
|
32,533
|
|
Short-term marketable
securities (1)
|
|
55,671
|
|
62,410
|
|
Accounts receivable,
net
|
|
38,829
|
|
37,164
|
|
Prepaid expenses and
other current assets
|
|
11,352
|
|
10,843
|
|
Total current
assets
|
|
136,557
|
|
142,950
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
39,311
|
|
39,746
|
|
Other
assets
|
|
1,853
|
|
1,921
|
|
Total
assets
|
|
$
|
177,721
|
|
$
|
184,617
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,702
|
|
$
|
8,585
|
|
Accrued expenses and
other current liabilities
|
|
32,360
|
|
33,656
|
|
Deferred
revenues
|
|
374
|
|
431
|
|
Other
liabilities
|
|
2,874
|
|
2,410
|
|
Stockholders'
equity
|
|
137,411
|
|
139,535
|
|
Total liabilities and
stockholders' equity
|
|
$
|
177,721
|
|
$
|
184,617
|
|
|
|
|
|
|
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 Form 10-K for the fiscal year ended
December 31, 2015.
|
|
|
(1)
|
Included in
short-term marketable securities as of March 31, 2016 and December
31, 2015 was $18.9 million and $18.1 million, respectively, of
corporate equity securities, representing the Company's investment
in Invitae Corporation.
|
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SOURCE Genomic Health, Inc.