REDWOOD CITY, Calif.,
Nov. 3, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter ended
September 30, 2015.
Revenue was $73.6 million in the
third quarter of 2015 compared with $69.1
million for the third quarter of 2014, an increase of 6
percent. On a constant currency basis, revenue increased 8 percent
compared with the same period in the prior year.
U.S. revenue was $63.1 million in
the third quarter of 2015, an increase of 9 percent compared with
the same period in the prior year. International revenue was
$10.5 million in the third quarter of
2015 compared with $11.3 million a
year ago. International revenue was impacted negatively by
$0.9 million from foreign exchange
rate differences due to the stronger dollar.
More than 27,820 Oncotype DX® test results were
delivered in the third quarter of 2015, compared with more than
23,700 test results delivered in the same period in 2014, an
increase of 17 percent. International test results delivered grew
30 percent compared with the prior year and represented
approximately 22 percent of total test volume in the third quarter
of 2015.
"In the third quarter, we delivered the highest level of test
growth in two years and nearly double-digit revenue growth in the
U.S.," said Kim Popovits, chairman of the board, chief executive
officer and president of Genomic Health. "With the recently
published TAILORx prospective outcomes data supporting our invasive
breast cancer test, Medicare coverage of our prostate cancer test,
and momentum for both our international and DCIS breast cancer
business, we expect to deliver double-digit test and revenue growth
in the fourth quarter."
Operating loss for the third quarter narrowed to $5.4 million compared with $5.8 million for the third quarter of 2014. Net
loss was $11.8 million for the third
quarter of 2015 and includes a $6.2
million tax expense 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 $0.36 for the third quarter of 2015 compared with
basic and diluted net loss per share of $0.20 for the same period in 2014.
Nine Months Ended September 30,
2015, Financial Results
Revenue for the nine months ended September 30, 2015, was $212.3 million compared with $206.6 million for the nine months ended
September 30, 2014. On a constant
currency basis, revenue increased 4 percent compared with the same
period in the prior year.
Operating loss was $30.9 million
for the nine months ended September 30,
2015, compared with an operating loss of $17.6 million for the nine months ended
September 30, 2014. The operating
loss for the nine months ended September 30,
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 and continued
planned investments in prostate and international
opportunities.
Net loss was $30.6 million for the
nine months ended September 30, 2015,
compared with a net loss of $18.3
million for the nine months ended September 30, 2014.
Cash and cash equivalents and short-term marketable securities
at September 30, 2015, were
$98.0 million including the fair
value of the company's investment in a marketable security of
$15.9 million, compared with
$103.7 million at December 31, 2014.
"Medicare coverage for our Oncotype DX prostate cancer test
became effective October 13, which will lead to revenue in the
fourth quarter from prostate cancer tests delivered to eligible
Medicare patients, a key milestone for generating consistent
double-digit revenue growth and moving toward profitability,"
said Brad Cole, chief operating officer and chief financial
officer of Genomic Health.
Recent Business Highlights
Oncotype DX Commercial Progress
- Palmetto GBA, a Medicare Administrative Contractor (MAC) that
assesses molecular diagnostic technologies, initiated reimbursement
coverage of the Oncotype DX prostate cancer test for qualified
Medicare patients throughout the United
States effective October 13,
2015.
- Expanded coverage of the Oncotype DX breast cancer test for
patients with 1-3 positive nodes to include 5 million additional
lives through a new policy with Highmark Blue Cross and Blue
Shield.
- The National Institutes of Health's (NIH) Genetic Testing
Registry, a free online resource to provide physicians, researchers
and patients with detailed and accurate information about genetic
and genomic tests, now includes information on the Oncotype DX DCIS
Score™, Genomic Prostate Score and colon cancer Recurrence
Score®.
Pipeline, Presentations and Publications
- The New England Journal of Medicine published the first
prospective outcomes results from the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, a large multi-center trial sponsored by
the National Cancer Institute (NCI), part of the National
Institutes of Health, and led by the ECOG-ACRIN Cancer Research
Group, demonstrating that trial participants with low Oncotype DX
Recurrence Scores of 10 or less who received hormonal therapy alone
without chemotherapy had excellent outcomes, with less than a one
percent chance of distant recurrence at five years. The results
were also presented in a Presidential Session at the 2015 European
Cancer Congress (ECC2015) in Vienna.
- Two large international Oncotype DX clinical outcomes studies
presented at ECC2015 provided additional prospective data
reinforcing the ability of Oncotype DX to accurately predict
clinical outcomes in early-stage breast cancer patients.
- The Japan Breast Cancer Society updated its Breast Cancer
Management Guidelines, recommending Oncotype DX as the only test
for use in determining chemotherapy treatment in hormone
receptor-positive, early-stage breast cancer.
- Presented additional positive results from the second large,
independent clinical validation study of the Oncotype DX DCIS Score
at the American Society for Therapeutic Radiology and Oncology
annual meeting. Results reconfirm that the test is a strong
independent predictor of local recurrence, which could be either
invasive breast cancer or DCIS, in patients with DCIS.
- Received acceptance to present eight studies at the 2015
CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), including a
poster presentation on outcomes in patients using the Oncotype DX
invasive breast cancer test through a collaboration with The
Surveillance, Epidemiology, and End Results (SEER) registry.
Conference Call Details
To access the live conference call today, November 3, 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 54340252. Please dial in approximately 10
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 over half a million patients tested in more than 90 countries,
the Oncotype DX tests have redefined personalized medicine by
making genomics a critical part of cancer diagnosis and treatment.
To learn more about Oncotype DX 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 double-digit revenue growth by the
end of the year; the company's expectations regarding the timing of
Medicare revenue and coverage for its prostate cancer test; the
company's expectations regarding continued test growth and
reimbursement success; and the company's expectations regarding
full year 2015 results. 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 quarterly report on Form 10-Q
for the quarter ended June 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, 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) (Unaudited)
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
REVENUES:
|
|
|
|
|
|
|
|
|
Product
revenues – United States
|
|
$
|
63,051
|
|
$
|
57,777
|
|
$
|
181,459
|
|
$
|
171,863
|
Product
revenues – Outside of the United States
|
|
|
10,503
|
|
|
11,324
|
|
|
30,866
|
|
|
34,717
|
Total product
revenues
|
|
|
73,554
|
|
|
69,101
|
|
|
212,325
|
|
|
206,580
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
13,718
|
|
11,979
|
|
39,513
|
|
36,241
|
Research and
development
|
|
13,480
|
|
13,891
|
|
47,193
|
|
40,527
|
Selling and
marketing
|
|
35,369
|
|
34,059
|
|
107,964
|
|
102,702
|
General and
administrative
|
|
16,425
|
|
15,007
|
|
48,594
|
|
44,750
|
Total operating
expenses
|
|
78,992
|
|
74,936
|
|
243,264
|
|
224,220
|
Loss from
operations
|
|
(5,438)
|
|
(5,835)
|
|
(30,939)
|
|
(17,640)
|
Interest
income
|
|
54
|
|
47
|
|
163
|
|
144
|
Other income
(expense), net
|
|
(158)
|
|
(345)
|
|
(207)
|
|
(537)
|
Loss before income
taxes
|
|
(5,542)
|
|
(6,133)
|
|
(30,983)
|
|
(18,033)
|
|
|
|
|
|
|
|
|
|
Income tax (benefit)
expense
|
|
6,301
|
|
129
|
|
(410)
|
|
292
|
Net loss
|
|
$
|
(11,843)
|
|
$
|
(6,262)
|
|
$
|
(30,573)
|
|
$
|
(18,325)
|
Basic and diluted net
loss per share
|
|
$
|
(0.36)
|
|
$
|
(0.20)
|
|
$
|
(0.95)
|
|
$
|
(0.58)
|
Shares used in
computing basic and diluted net loss per share
|
|
32,498
|
|
31,590
|
|
32,294
|
|
31,339
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended September 30, 2015, 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 2014 of $5.7 million, including $4.0 million of
stock-based compensation expense and $1.7 million of depreciation
and amortization expenses.
|
|
|
(2)
|
Included in operating
expenses for the nine months ended September 30, 2015, were
non-cash charges of $17.2 million, including $12.1 million of
stock-based compensation expense and $5.1 million of depreciation
and amortization expenses, compared with non-cash charges for the
same period in 2014 of $17.8 million, including $12.6 million of
stock-based compensation expense and $5.2 million of depreciation
and amortization expenses.
|
GENOMIC
HEALTH, INC. Condensed Consolidated Balance
Sheets (In thousands)
|
|
|
|
As of
September 30,
2015
|
|
As of
December 31,
2014
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
28,010
|
|
$
|
29,726
|
Short-term marketable
securities (1)
|
|
70,003
|
|
73,934
|
Accounts receivable,
net
|
|
33,754
|
|
34,916
|
Prepaid expenses and
other current assets
|
|
10,238
|
|
9,944
|
Total current
assets
|
|
142,005
|
|
148,520
|
|
|
|
|
|
Property and
equipment, net
|
|
34,682
|
|
21,860
|
Other
assets
|
|
1,656
|
|
15,541
|
Total
assets
|
|
$
|
178,343
|
|
$
|
185,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,595
|
|
$
|
6,987
|
Accrued expenses and
other current liabilities
|
|
37,674
|
|
31,016
|
Deferred
revenues
|
|
251
|
|
335
|
Other
liabilities
|
|
2,294
|
|
2,070
|
Stockholders'
equity
|
|
132,529
|
|
145,513
|
Total liabilities and
stockholders' equity
|
|
$
|
178,343
|
|
$
|
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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2014.
|
|
(1)
|
Included in
short-term marketable securities as of September 30, 2015, was
$15.9 million of corporate equity securities, representing the
Company's investment in Invitae Corporation.
|
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SOURCE Genomic Health, Inc.