REDWOOD CITY, Calif.,
May 5, 2015 /PRNewswire/ -- Genomic
Health, Inc. (Nasdaq: GHDX) today reported financial results and
business progress for the quarter ended March 31, 2015.
Product revenue was $68.2 million
in the first quarter of 2015, compared with $67.0 million for the first quarter of 2014, an
increase of 2 percent. On a constant currency basis, product
revenue increased 3 percent compared with the prior year.
International product revenue was $10.4
million in the first quarter of 2015 and represented 15
percent of product revenue in the quarter.
Reported total product revenue was impacted negatively by
$0.8 million from foreign exchange
(FX) rate differences due to the stronger dollar in the first
quarter of 2015, as compared to a year ago. This significant
FX change impacted growth in reported international revenues by
approximately 8 percent.
"With successful execution of all critical growth drivers, we
delivered record Oncotype DX test volume in the first quarter
including nearly 50 percent year-over-year growth in DCIS,
increased international use by seven percent, nearly triple the
number of prostate cancer tests delivered, and a four percent
increase in U.S. breast product revenue compared to the first
quarter of last year," said Kim Popovits, Chairman of the Board,
Chief Executive Officer and President of Genomic Health. "Looking
ahead we believe we are well positioned to deliver key
reimbursement milestones and clinical data presentations to drive
further test utilization and revenue growth, returning us to
profitability by the end of the year, while strengthening our
position at the forefront of precision medicine with our liquid
biopsy pipeline."
Net loss was $9.5 million for the
first quarter of 2015, compared with net loss of $7.4 million in the first quarter of 2014.
Basic and diluted net loss per share was $0.30 for the first quarter of 2015, compared
with basic and diluted net loss per share of $0.24 for the same period in 2014.
A $5.5 million tax benefit was
recognized in the first quarter as a result of the increase in the
fair value of the Company's interest in Invitae Corporation as of
March 31, which is now a public
company and newly accounted for as an available-for-sale
investment. Accounting rules require a tax benefit to be
recognized in reporting periods with an unrealized gain in other
comprehensive income and a pre-tax loss.
Additional First Quarter 2015 Financial Results
Total operating expenses for the first quarter of 2015 were
$82.8 million, compared with total
operating expenses of $74.2 million
in the first quarter of 2014. Included in first quarter operating
expenses is a non-recurring item of $5.5
million in R&D associated with the wind down of a breast
cancer collaboration.
Cash and cash equivalents and short-term marketable securities
at March 31, 2015, excluding the
Company's available-for-sale investment in Invitae, were
$91.0 million, compared with
$103.7 million at December 31, 2014.
More than 25,430 Oncotype DX® test results were
delivered in the first quarter of 2015, an increase of 10 percent,
compared with more than 23,080 test results delivered in the same
period in 2014. International tests delivered grew 7 percent
compared to the prior year and represented approximately 20 percent
of total test volume in the first quarter of 2015.
Recent Business Highlights:
Oncotype DX Commercial Progress
- Oncotype DX remains the only multi-gene breast cancer test
broadly supported by worldwide treatment guidelines, including a
new update to the National Comprehensive Cancer Network (NCCN)
guidelines with a favorable reference to Oncotype DX for use
in patients with node-positive breast cancer.
- The German Association of Gynecological Oncology's (AGO's)
treatment guidelines were recently expanded to include the Oncotype
DX breast cancer test for node-positive disease and late
recurrence. Furthermore, the guidelines reconfirmed the Oncotype DX
test as the only gene expression test that provides predictive
information on the likelihood of chemotherapy benefit for patients
with early-stage, hormone-receptor positive invasive breast
cancer.
- The German Federal Joint Committee (G-BA) announced that it
will reimburse genomic tests for selected breast cancer patients in
specific treatment settings.
- Results of two studies demonstrating that the Oncotype DX
breast cancer test represents a cost-effective use of healthcare
resources in Mexico and
the Netherlands were recently
published.
- Secured first purchase agreements with U.S. government
facilities for the Oncotype DX prostate cancer test.
- The American Medical Association (AMA) granted a test-specific
Current Procedural Terminology (CPT) code for the Oncotype DX colon
cancer test.
Pipeline, Presentations and Publications
- Urology Practice, an official journal of the
American Urological Association, published results of the first
decision impact study of the Oncotype DX prostate cancer test, and
accepted the second decision impact study for future
publication.
- Recently began enrolling French breast cancer patients in the
RxPONDER trial utilizing Oncotype DX in women with node-positive
disease.
- Pharmaceuticals published positive results from an
analysis that demonstrated Oncotype DX should be an integral part
of the treatment planning process for patients with node-positive
micrometastatic breast cancer.
- The Journal of Surgical Oncology accepted results of the
first decision impact study of the Oncotype DX DCIS Score™ for
publication.
- Presented positive results from 11 studies that demonstrate the
direct patient impact of the Oncotype DX breast cancer test
globally at the 14th St. Gallen International Breast Cancer
Conference, including positive results from a real-life
observational study in Ireland.
- Received acceptance to present five studies at the upcoming
American Urological Association (AUA) Annual Meeting, including
Oncotype DX prostate cancer test clinical utility studies and new
data supporting the development of novel liquid biopsy-based cancer
tests.
- Received acceptance to present four abstracts at the upcoming
American Society of Clinical Oncology (ASCO) Annual Meeting
May 29 - June 2, including studies in
breast and prostate cancer.
- Received acceptance to present a liquid biopsy proof-of-concept
study in bladder cancer at the American Association for Cancer
Research (AACR) Precision Medicine meeting in June.
Conference Call Details
To access the live conference call today, May 5 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 18777629. 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 Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer
tests applies advanced genomic science to reveal the unique biology
of a tumor in order to optimize cancer treatment decisions. With
half a million patients tested in more than 80 countries, the
Oncotype DX tests have redefined personalized medicine by making
genomics a critical part of cancer diagnosis and treatment. To
learn more about OncotypeDX tests,
visit: www.OncotypeDX.com,
www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.
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
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. The
company is based in Redwood City, California with
European 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 to the company's belief that it
is well positioned to deliver key reimbursement milestones and data
presentations to drive further test utilization and revenue growth,
returning the company to profitability by the end of the year and
strengthening its position at the forefront of genomic medicine
with its liquid biopsy program; the company's expectations
regarding implementation of reimbursement for genomic tests in
Germany. 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 and timing of 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, within its time expectations or at all, 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; 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, 2014. 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, and DCIS Score 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,
|
|
|
|
2015
|
|
2014
|
|
|
|
(Unaudited)
|
|
REVENUES:
|
|
|
|
|
|
Product
revenues
|
|
$
|
68,152
|
|
$
|
67,002
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1):
|
|
|
|
|
|
Cost of product
revenues
|
|
12,762
|
|
12,055
|
|
Research and
development
|
|
19,118
|
|
14,005
|
|
Selling and
marketing
|
|
35,352
|
|
33,408
|
|
General and
administrative
|
|
15,589
|
|
14,728
|
|
Total operating
expenses
|
|
82,821
|
|
74,196
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(14,669)
|
|
(7,194)
|
|
|
|
|
|
|
|
Interest
income
|
|
54
|
|
50
|
|
Other income
(expense), net
|
|
(374)
|
|
(226)
|
|
Loss before income
taxes
|
|
(14,989)
|
|
(7,370)
|
|
|
|
|
|
|
|
Income tax expense
(benefit)
|
|
(5,496)
|
|
75
|
|
Net loss
|
|
$
|
(9,493)
|
|
$
|
(7,445)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.30)
|
|
$
|
(0.24)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
32,055
|
|
31,087
|
|
|
|
(1)
|
Included in operating
expenses for the first quarter of 2015 were non-cash charges of
$5.9 million, including $4.2 million of stock-based compensation
expense and $1.7 million of depreciation and amortization expenses,
compared with non-cash charges for the same period in 2014 of $6.1
million, including $4.4 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,
2015
|
|
As of
December 31,
2014
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
22,938
|
|
$
|
29,726
|
|
Short-term marketable
securities (1)
|
|
105,042
|
|
73,934
|
|
Accounts receivable,
net
|
|
34,979
|
|
34,916
|
|
Prepaid expenses and
other current assets
|
|
12,085
|
|
9,944
|
|
Total current
assets
|
|
175,044
|
|
148,520
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
25,171
|
|
21,860
|
|
Other
assets
|
|
1,755
|
|
15,541
|
|
Total
assets
|
|
$
|
201,970
|
|
$
|
185,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
7,952
|
|
$
|
6,987
|
|
Accrued expenses and
other current liabilities
|
|
34,355
|
|
31,016
|
|
Deferred
revenues
|
|
268
|
|
335
|
|
Other
liabilities
|
|
2,667
|
|
2,070
|
|
Stockholders'
equity
|
|
156,728
|
|
145,513
|
|
Total liabilities and
stockholders' equity
|
|
$
|
201,970
|
|
$
|
185,921
|
|
|
|
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 Form 10-K for the
fiscal year ended December 31, 2014
|
|
|
(1)
|
Included in short-term marketable securities as of
March 31, 2015 was $37.0 million of corporate equity securities,
representing the Company's investment in Invitae
Corporation.
|
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SOURCE Genomic Health, Inc.