REDWOOD CITY, Calif.,
Feb. 10, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter and year
ended December 31, 2015.
Revenue was $74.5 million in the
fourth quarter of 2015, compared with $69.1
million in the fourth quarter of 2014, an increase of 8
percent. On a constant currency basis, revenue increased 9 percent
compared with the same period in the prior year.
U.S. revenue was $63.9 million in
the fourth quarter of 2015, an increase of 9 percent compared with
the same period in the prior year. International revenue was
$10.6 million in the fourth quarter
of 2015, compared with $10.3 million
a year ago. International revenue was reduced by $0.6 million from foreign exchange rate
differences due to the stronger dollar as compared to a year
ago.
Revenue was $286.8 million in the
full year 2015, compared with $275.7
million in 2014, an increase of 4 percent. International
revenue for the full year 2015 was $41.4
million, compared with $45.0
million a year ago. For the year ended December 31, 2015, international revenue was
reduced by approximately $3.0 million
from foreign exchange rate differences due to the stronger dollar
as compared to a year ago.
More than 107,030 Oncotype DX® test results were
delivered for the year ended December 31,
2015, an increase of 12 percent, compared with more than
95,610 test results delivered in 2014. In the fourth quarter of
2015, more than 27,730 Oncotype DX test results were delivered, an
increase of 12 percent, compared with more than 24,770 test results
delivered in the same period in 2014. Prostate tests delivered in
the United States for the full
year grew 75 percent compared to the prior year and represented
approximately 8 percent of total test volume in 2015. International
tests delivered in the full-year grew 19 percent compared to the
prior year and represented approximately 21 percent of total test
volume in 2015.
"We expect the strong momentum generated across our business in
2015, combined with new compelling global prospective outcomes
evidence for the Oncotype DX breast cancer test and recent Medicare
coverage for the Oncotype DX prostate cancer test, to lead to
double-digit test and revenue growth in 2016," said Kim Popovits,
Chairman of the Board, Chief Executive Officer and President of
Genomic Health. "Additionally, we are excited to continue our
impact in making cancer care smarter by launching our first liquid
biopsy test, Oncotype SEQ™, in mid-2016."
Operating loss for the fourth quarter narrowed to $3.5 million compared with $6.0 million for the fourth quarter of 2014. Net
loss was $3.2 million for the fourth
quarter of 2015 and includes a $0.8
million tax credit in the quarter resulting from a change in
fair value of the company's investment in a marketable security.
Basic and diluted net loss per share was $0.10 for the fourth quarter of 2015 compared
with basic and diluted net loss per share of $0.20 for the same period in 2014.
Additional Year-End 2015 Financial Results
Operating loss was $34.5 million
for the year ended December 31, 2015,
compared with an operating loss of $23.6
million for the year ended December
31, 2014. The operating loss for the year ended December 31, 2015 includes a non-recurring first
quarter charge of $5.5 million in
R&D associated with the wind-down of a breast cancer
collaboration.
Net loss was $33.8 million for the
year ended December 31, 2015,
compared with a net loss of $24.6
million for the year ended December
31, 2014. Basic and diluted net loss per share was
$1.04 for the year ended December 31, 2015, compared with a basic and
diluted net loss per share of $0.78
for the year ended December 31,
2014.
Cash and cash equivalents and short-term investments at
December 31, 2015 were $76.8 million, excluding the fair value of the
company's investment in a marketable security of $18.1 million, compared with $103.7 million at December
31, 2014.
2016 Financial Guidance
"In 2016 we plan to deliver double-digit test and revenue growth
and improve our net loss, while delivering positive
EBITDA*," said Brad Cole, Chief Operating Officer and
Chief Financial Officer of Genomic Health. "We expect our net loss
in the first half of the year to be within the full year loss
guidance of $12 to $18 million and to
move toward profitability in the second half of the year."
The company is providing the following financial guidance for
the full year ending December 31,
2016:
- Total revenue of $320 to $335
million, representing growth of between 12 and 17 percent
compared to 2015;
- Net loss between $12 and $18
million at the mid-point of revenue guidance, excluding the
effect of the company's investment in a marketable security, or
basic net loss per share of between $0.37
and $0.55; and
- Oncotype DX tests delivered of 117,500 to 121,000, representing
growth of between 10 and 13 percent compared to 2015.
*EBITDA, or earnings before interest, taxes,
depreciation and amortization, is a non-GAAP term.
Recent Business Highlights:
Oncotype DX Commercial Progress
- Implemented new enterprise-wide platform (ERP) to add novel
capabilities and provide the ability to scale the company's growing
business.
- Expanded coverage of the Oncotype DX breast cancer test for
patients with 1-3 positive nodes to include 11 million additional
lives through new policies with Health Net, Blue Cross Blue Shield
of Florida and Independent Blue
Cross. This brings the total number of node-positive covered lives
to more than 161 million U.S. lives.
- Received positive reimbursement decisions for the Oncotype DX
breast cancer test in four additional regions of Spain bringing the total number of ex-U.S.
lives covered to 196 million.
- The Centers for Medicare and Medicaid Services (CMS), which
administers the Medicare program, issued its final Clinical
Laboratory Fee Schedule (CLFS) for 2016, which will allow the
Medicare Administrative Contractor (MAC) to continue to set payment
for the Oncotype DX colon cancer test through 2016, as has been
done since initiation of coverage in 2011.
Pipeline, Presentations and Publications
- Announced plans to launch first liquid biopsy test, Oncotype
SEQ™, a blood-based mutation panel that uses next-generation
sequencing to identify select actionable genomic alterations for
the treatment of patients with late-stage lung, breast, colon,
melanoma, ovarian or gastrointestinal cancer, in mid-2016. Oncotype
SEQ represents the first of several liquid biopsy tests that
Genomic Health plans to deliver through the introduction of its
Oncotype IQ™ Genomic Intelligence Platform.
- Urology published a meta-analysis of the original
Oncotype DX clinical validation studies demonstrating the ability
of the Genomic Prostate Score (GPS) to refine risk stratification
for low- and intermediate-risk patients with greater precision
compared to clinical classifiers alone.
- Positive results from a large prospective outcomes study in
Germany were accepted for
publication in the Journal of Clinical Oncology. Led by the
Women's Healthcare Study Group, the PlanB study demonstrated that
women with breast Recurrence Score® results of 11 or
less who were treated with hormonal therapy alone had excellent
outcomes with 98 percent disease-free survival rates at three years
despite having intermediate- or high-risk disease by traditional
parameters.
- Received acceptance to present five year outcomes data from the
PlanB study in an oral presentation at the upcoming European Breast
Cancer Conference in March.
- Announced results from multiple Oncotype DX breast cancer test
studies at the 38th CTRC-AACR San Antonio Breast Cancer
Symposium (SABCS) reconfirming that Oncotype DX accurately predicts
clinical outcomes – including risk of recurrence and breast cancer
survival - in early-stage patients with invasive breast cancer.
Data include results from the Surveillance, Epidemiology, and End
Results (SEER) program of the National Cancer Institute (NCI);
complete results from a multi-center study from Clalit Health
Services, the largest health maintenance organization in
Israel; additional analyses from
the NCI-sponsored Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx; and the German PlanB study.
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
34365800. 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 its investments in DCIS, prostate
cancer and international markets; the company's full year 2015
results; 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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 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
|
|
Twelve Months Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
Unaudited
|
|
Unaudited
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Product revenues –
United States
|
|
$
|
63,918
|
|
$
|
58,794
|
|
$
|
245,378
|
|
$
|
230,657
|
|
Product revenues –
Outside of the United States
|
|
10,582
|
|
10,332
|
|
41,447
|
|
45,049
|
|
Total
revenues
|
|
74,500
|
|
69,126
|
|
286,825
|
|
275,706
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
14,078
|
|
12,501
|
|
53,591
|
|
48,742
|
|
Research and
development
|
|
12,605
|
|
12,549
|
|
59,798
|
|
53,076
|
|
Selling and
marketing
|
|
35,593
|
|
35,144
|
|
143,557
|
|
137,846
|
|
General and
administrative
|
|
15,755
|
|
14,919
|
|
64,348
|
|
59,669
|
|
Total operating
expenses
|
|
78,031
|
|
75,113
|
|
321,294
|
|
299,333
|
|
Loss from
operations
|
|
(3,531)
|
|
(5,987)
|
|
(34,469)
|
|
(23,627)
|
|
Interest
income
|
|
58
|
|
48
|
|
221
|
|
192
|
|
Other income
(expense), net
|
|
(291)
|
|
(227)
|
|
(498)
|
|
(764)
|
|
Loss before income
taxes
|
|
(3,764)
|
|
(6,166)
|
|
(34,746)
|
|
(24,199)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit)
|
|
(587)
|
|
101
|
|
(996)
|
|
393
|
|
Net loss
|
|
$
|
(3,177)
|
|
$
|
(6,267)
|
|
$
|
(33,750)
|
|
$
|
(24,592)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.10)
|
|
$
|
(0.20)
|
|
$
|
(1.04)
|
|
$
|
(0.78)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
32,645
|
|
31,791
|
|
32,382
|
|
31,453
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended December 31, 2015 were non-cash
charges of $6.0 million, including $4.0 million of stock-based
compensation expense and $2.0 million of depreciation and
amortization expenses, compared with non-cash charges for the same
period in 2014 of $5.6 million, including $3.9 million of
stock-based compensation expense and $1.7 million of depreciation
and amortization expenses.
|
|
|
(2)
|
Included in operating
expenses for the twelve months ended December 31, 2015 were
non-cash charges of $23.1 million, including $16.0 million of
stock-based compensation expense and $7.1 million of depreciation
and amortization expenses, compared with non-cash charges for the
same period in 2014 of $23.4 million, including $16.5 million of
stock-based compensation expense and $6.9 million of depreciation
and amortization expenses.
|
GENOMIC
HEALTH, INC.
|
Condensed
Consolidated Balance Sheets
|
(In
thousands)
|
|
|
|
As
of December 31,
2015
|
|
As of
December 31,
2014
|
|
|
|
(Unaudited)
|
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
32,533
|
|
$
|
29,726
|
|
Short-term marketable
securities (2)
|
|
62,410
|
|
73,934
|
|
Accounts receivable,
net
|
|
36,531
|
|
34,916
|
|
Prepaid expenses and
other current assets
|
|
10,844
|
|
9,944
|
|
Total current
assets
|
|
142,318
|
|
148,520
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
39,746
|
|
21,860
|
|
Other
assets
|
|
1,921
|
|
15,541
|
|
Total
assets
|
|
$
|
183,985
|
|
$
|
185,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
8,395
|
|
$
|
6,987
|
|
Accrued expenses and
other current liabilities
|
|
33,656
|
|
31,016
|
|
Deferred
revenues
|
|
431
|
|
335
|
|
Other
liabilities
|
|
2,410
|
|
2,070
|
|
Stockholders'
equity
|
|
139,093
|
|
145,513
|
|
Total liabilities and
stockholders' equity
|
|
$
|
183,985
|
|
$
|
185,921
|
|
|
|
(1)
|
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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2014.
|
|
|
(2)
|
Included in
short-term marketable securities as of December 31, 2015, was $18.1
million of corporate equity securities, representing the Company's
investment in Invitae Corporation.
|
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SOURCE Genomic Health, Inc.