REDWOOD CITY, Calif.,
Feb. 10, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter and year
ended December 31, 2014.
Product revenue was $69.1 million
in the fourth quarter of 2014, compared with $67.1 million for the fourth quarter of 2013, an
increase of 3 percent. Total revenue for the fourth quarter
of 2014 was $69.1 million, compared
with $68.8 million in the fourth
quarter of 2013, which included $1.8
million of contract revenue.
Product revenue was $275.7 million
for the full-year 2014, compared with $259.2
million in 2013, an increase of 6 percent. Total
revenue for the year ended December 31,
2014 increased to $275.7
million, compared with $261.6
million in 2013.
International product revenue was $10.3
million and represented 15 percent of product revenue in the
fourth quarter of 2014. International product revenue for the
full-year 2014 was $45.0 million,
representing 16 percent of product revenue, and grew 19 percent
compared to the prior year.
Net loss was $6.3 million for the
fourth quarter of 2014, compared with net loss of $9.4 million in the fourth quarter of 2013.
Net loss was $24.6 million for the
year ended December 31, 2014,
compared with net loss of $12.8
million for the year ended December
31, 2013.
Basic and diluted net loss per share was $0.20 for the fourth quarter of 2014, compared
with a basic and diluted net loss per share of $0.30 for the same period in 2013. Basic and
diluted net loss per share was $0.78
for the year ended December 31, 2014,
compared with a basic and diluted net loss per share for the year
ended December 31, 2013 of
$0.42.
"In 2014, we delivered solid growth driven by increased
worldwide penetration of the Oncotype DX breast cancer market and
growing U.S. adoption of our prostate cancer test," said Kim
Popovits, Chairman of the Board, Chief Executive Officer and
President of Genomic Health. "With multiple published prostate
cancer studies, additional positive DCIS data and an established
pathway for our breast cancer test through NHS in the UK, we
believe we are well positioned for near-term growth in these new
markets as our aggressive investments begin to pay off.
Additionally, we are advancing our pipeline with larger-scale
clinical studies to support the launch of our first liquid biopsy
test in 2016."
Additional Year-End 2014 Financial Results
Total operating expenses for the full year 2014 were
$299.3 million, compared with total
operating expenses of $273.4 million
in 2013.
Cash and cash equivalents and short-term investments at
December 31, 2014 were $103.7 million, compared with $105.4 million at December
31, 2013.
More than 95,610 Oncotype DX® test results were
delivered for the year ended December 31,
2014, an increase of 12 percent, compared with more than
85,500 test results delivered in 2013. In the fourth quarter
of 2014, more than 24,770 Oncotype DX test results were delivered,
an increase of 9 percent, compared with more than 22,720 test
results delivered in the same period in 2013. International
tests delivered grew 23 percent compared to the prior year and
represented approximately 20 percent of total test volume in
2014.
2015 Financial Guidance
The company is providing the following financial guidance for
the full-year ending December 31,
2015:
- Total revenue of $292 to $305
million;
- Net loss between $17 and $24
million, or basic net loss per share of between $0.53 and $0.75; and
- Oncotype DX tests delivered of 102,000 to 109,000.
"In 2015, we plan to narrow our full-year loss and deliver a
profit in the fourth quarter," said Brad Cole, Chief Operating
Officer and Chief Financial Officer of Genomic Health. "With
anticipated reimbursement for our prostate cancer test in the U.S.,
our breast cancer test in the UK being available through NHS and
increasing DCIS adoption, we expect product revenue to grow between
six and 11 percent with double digit year-over-year growth in the
second half of 2015. "
Recent Business Highlights:
Oncotype DX Commercial Progress
- Announced that beginning April 1,
2015 the Oncotype DX breast cancer test will be available
for eligible breast cancer patients through the National Health
Service (NHS) in England as the
only multi-gene breast cancer test recommended as an option by NICE
for chemotherapy treatment decision-making.
- Received positive reimbursement decision for the Oncotype DX
breast cancer test through the mandatory health insurance system in
Switzerland.
- ECOG-ACRIN Cancer Research Group announced a new NCI-sponsored
clinical trial for women with newly diagnosed DCIS (ductal
carcinoma in situ) which requires the Oncotype DX DCIS Score to
estimate the risk of recurrence to guide the use of radiation
following lumpectomy.
Pipeline, Presentations and Publications
- Presented positive results from the second large, independent
clinical validation study of Oncotype DX in patients with DCIS
breast cancer at the San Antonio Breast Cancer Symposium (SABCS).
Results of this study, the largest genomic study in DCIS to date,
reconfirm that Oncotype DX is a strong, independent predictor of
any local recurrence.
- Presented first prospective outcomes data from a large European
invasive breast cancer trial led by the Women's Healthcare Study
Group, WSG, demonstrating 98.3 percent recurrence free survival
among patients identified as low risk by Oncotype DX at three-year
follow-up.
- Received acceptance to present ten studies at the upcoming
14th St. Gallen Breast Cancer
Conference in March.
- Twenty studies across multiple cancers, including a new liquid
biopsy study, were accepted for presentation at recent and upcoming
U.S. medical meetings including the American Society of Clinical
Oncology (ASCO) Gastrointestinal and Genitourinary Cancers
Symposiums, United States &
Canadian Academy of Pathology (USCAP) annual meeting and American
Urological Association (AUA) annual meeting.
- European Urology published the results
from the latest validation study of the Oncotype DX prostate cancer
test, conducted in collaboration with the Center for Prostate
Disease Research.
- Results of the first decision impact study of the Oncotype DX
prostate cancer test were accepted for publication
in Urology Practice, an official journal of the American Urological
Association.
- Presented results from two studies of the Oncotype DX prostate
cancer test demonstrating its value in low- and intermediate-risk
prostate cancer to enable physicians and patients to avoid over-
and under-treatment of the disease at the Society of Urologic
Oncology (SUO) Annual Meeting.
- Advanced the development of novel liquid biopsy-based cancer
tests with the presentation of positive results from the first two
feasibility studies assessing multiple technologies, including
next-generation sequencing, for their ability to detect and
characterize the presence of bladder cancer DNA in urine and breast
cancer DNA in blood, at SUO and SABCS, respectively.
Conference Call Details
To access the live conference
call today, February 10 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
75998165. 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 70 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 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
positive study results will drive further reimbursement and
adoption of its prostate cancer and breast cancer tests; the
company's expectations regarding reporting study results; the
company's beliefs regarding its liquid biopsy platform and the
timing of a liquid biopsy test; the company's intent to continue
its investments in DCIS, prostate cancer and international markets;
the company's expectations regarding full year 2015 results; the
attributes and focus of the company's product pipeline; the
applicability of clinical study results to actual outcomes; the
company's beliefs regarding the benefits and attributes of its
tests; 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 Quarterly Report on Form
10-Q for the quarter ended September 30,
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
|
|
Twelve Months Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
Unaudited
|
|
Unaudited
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Product
revenues
|
|
$
|
69,126
|
|
$
|
67,060
|
|
$
|
275,706
|
|
$
|
259,192
|
|
Contract
revenues
|
|
-
|
|
1,759
|
|
-
|
|
2,403
|
|
Total
revenues
|
|
69,126
|
|
68,819
|
|
275,706
|
|
261,595
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
12,501
|
|
10,815
|
|
48,742
|
|
42,100
|
|
Research and
development
|
|
13,346
|
|
24,144
|
|
56,064
|
|
66,333
|
|
Selling and
marketing
|
|
34,347
|
|
29,016
|
|
134,858
|
|
110,602
|
|
General and
administrative
|
|
14,919
|
|
13,340
|
|
59,669
|
|
54,392
|
|
Total operating
expenses
|
|
75,113
|
|
77,315
|
|
299,333
|
|
273,427
|
|
Loss from
operations
|
|
(5,987)
|
|
(8,496)
|
|
(23,627)
|
|
(11,832)
|
|
Interest
income
|
|
48
|
|
49
|
|
192
|
|
222
|
|
Impairment in
investments
|
|
-
|
|
(643)
|
|
-
|
|
(643)
|
|
Other income
(expense), net
|
|
(227)
|
|
(157)
|
|
(764)
|
|
(158)
|
|
Loss before income
taxes
|
|
(6,166)
|
|
(9,247)
|
|
(24,199)
|
|
(12,411)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
101
|
|
122
|
|
393
|
|
346
|
|
Net loss
|
|
$
|
(6,267)
|
|
$
|
(9,369)
|
|
$
|
(24,592)
|
|
$
|
(12,757)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.20)
|
|
$
|
(0.30)
|
|
$
|
(0.78)
|
|
$
|
(0.42)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
31,791
|
|
30,908
|
|
31,453
|
|
30,512
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended December 31, 2014 were non-cash
charges of $5.6 million, including $3.9 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 2013 of $6.1 million, including $4.6 million of
stock-based compensation expense and $1.5 million of depreciation
and amortization expenses.
|
|
|
(2)
|
Included in operating
expenses for the twelve months ended December 31, 2014 were
non-cash charges of $23.4 million, including $16.5 million of
stock-based compensation expense and $6.9 million of depreciation
and amortization expenses, compared with non-cash charges for the
same period in 2013 of $23.8 million, including $17.5 million of
stock-based compensation expense and $6.3 million of depreciation
and amortization expenses.
|
GENOMIC HEALTH,
INC.
|
Condensed
Consolidated Balance Sheets
|
(In
thousands)
|
|
|
|
As
of
December 31,
2014
|
|
As of
December 31,
2013
|
|
|
|
(Unaudited) (1)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
29,726
|
|
$
|
33,279
|
|
Short-term marketable
securities
|
|
73,934
|
|
72,071
|
|
Accounts receivable,
net
|
|
34,916
|
|
29,446
|
|
Prepaid expenses and
other current assets
|
|
9,944
|
|
10,196
|
|
Total current
assets
|
|
148,520
|
|
144,992
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
21,860
|
|
18,290
|
|
Other
assets
|
|
15,541
|
|
13,752
|
|
Total
assets
|
|
$
|
185,921
|
|
$
|
177,034
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
6,987
|
|
$
|
5,160
|
|
Accrued expenses and
other current liabilities
|
|
31,016
|
|
24,086
|
|
Deferred
revenues
|
|
335
|
|
586
|
|
Other
liabilities
|
|
2,070
|
|
2,221
|
|
Stockholders'
equity
|
|
145,513
|
|
144,981
|
|
Total liabilities and
stockholders' equity
|
|
$
|
185,921
|
|
$
|
177,034
|
|
|
|
(1)
|
The condensed
consolidated balance sheet at December 31, 2013 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, 2013.
|
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SOURCE Genomic Health, Inc.