REDWOOD CITY, Calif.,
Nov. 1, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter ended
September 30, 2016.
Total revenue was $82.3 million in
the third quarter of 2016, compared with $73.6 million in the third quarter of 2015, an
increase of 12 percent.
U.S. product revenue was $70.0
million in the third quarter of 2016, an increase of 11
percent, compared with $63.0 million
in the same period in the prior year. Prostate test revenue
in the U.S. of $2.3 million
contributed to approximately 3 percent of the year-over-year
growth.
International product revenue was $12.1
million in the third quarter of 2016, compared with
$10.5 million a year ago, an increase
of 15 percent. International revenue on a constant currency basis
increased by 18 percent compared with a year ago.i
In the third quarter, more than 29,990 Oncotype® test
results were delivered, an increase of 8 percent, compared with
more than 27,820 test results delivered in the third quarter of
2015. U.S. invasive breast tests delivered grew 5 percent and
prostate tests delivered grew 6 percent compared with the prior
year. International tests delivered grew 15 percent compared with
the prior year and represented approximately 24 percent of total
test volume in the third quarter of 2016.
"In 2016 we have delivered three consecutive quarters of
double-digit revenue growth, with 15 percent revenue growth and 12
percent test growth year-to-date, in line with our guidance
provided in February," said Kim Popovits, chairman of the board,
chief executive officer and president of Genomic Health. "We
believe these results demonstrate the strength of our business,
including the importance of continuing to generate clinical data
that differentiate our Oncotype IQ™ portfolio of products.
Specifically, in invasive breast cancer, Oncotype DX remains the
only genomic test proven to predict chemotherapy benefit and, with
our latest clinical validation study in prostate cancer announced
today, we now provide the only test to predict all major short- and
long-term outcomes."
Operating loss for the third quarter of 2016 improved to
$3.0 million, compared with
$5.4 million for the third quarter of
2015. The operating loss includes a favorable impact in the quarter
from the satisfaction of certain royalty payment obligations for
the license of PCR patents, as well as an unfavorable impact from a
write-down of a software development project for interactive
digital reporting. These two items were approximately $2.5 million each and individually off-set each
other.
Net loss was $2.8 million for the
third quarter of 2016 compared with a net loss of $11.8 million for the third quarter of 2015.
Basic and diluted net loss per share was $0.08 for the third quarter of 2016, compared
with basic and diluted net loss per share of $0.36 for the same period in 2015.
Total revenue for the nine months ended September 30, 2016 was $245.1 million, compared with $212.3 million for the nine months ended
September 30, 2015, an increase of 15
percent.
Operating loss improved to $16.9
million for the nine months ended September 30, 2016, compared with an operating
loss of $30.9 million for the nine
months ended September 30, 2015. Net
loss was $15.3 million for the nine
months ended September 30, 2016,
compared with a net loss of $30.6
million for the nine months ended September 30, 2015.
Cash and cash equivalents and short-term marketable securities
at September 30, 2016 were
$83.6 million excluding the fair
value of the company's investment in a marketable security of
$15.0 million, compared with
$76.8 million at December 31, 2015 excluding the fair value of the
company's investment in a marketable security of $18.1 million.
Recent Business Highlights
Oncotype DX Commercial Progress
- As of September 30, 2016, the
company's flagship line of Oncotype DX gene expression tests has
been used to guide treatment decisions for more than 700,000 cancer
patients worldwide.
- Established an additional coverage for the Oncotype DX Genomic
Prostate Score™, bringing the total number of prostate cancer
covered U.S. lives to more than 61 million.
Presentations and Publications
- Announced positive topline results from a prostate cancer
clinical validation study demonstrating Oncotype DX is a strong
predictor of the development of metastasis and prostate cancer
death in patients with early-stage disease. With these new results,
the Oncotype DX prostate cancer test becomes the first genomic test
validated in all major short- and long-term end points, including
adverse pathology, biochemical recurrence, metastasis and prostate
cancer specific death.
- Reviews in Urology published a comprehensive economic
analysis demonstrating use of Oncotype DX in low-risk prostate
cancer patients leads to an increase in a net uptake of active
surveillance and a net savings of $2,286 per patient – including the cost of the
test – by decreasing unnecessary immediate invasive treatment.
- Presented results from eight Oncotype DX Breast Recurrence
Score™ presentations at the European Society for Medical Oncology
(ESMO) 2016 Congress, highlighting superior clinical evidence in
identifying which patients with node-negative and node-positive
invasive breast cancer should be treated with chemotherapy. To
date, the unique clinical utility of Oncotype DX has been
demonstrated with prospective outcomes results in over 63,000
breast cancer patients.
- Presented robust analytical validation study results on
Oncotype SEQ® Liquid Select at the ESMO 2016 Congress.
The results demonstrated that this liquid biopsy mutation panel is
highly sensitive, specific and reproducible.
- Received acceptance to present seven studies at the 2016
CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in
December.
Conference Call Details
To access the live conference
call today, November 1, 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 6320020.
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 help optimize cancer care by addressing the
overtreatment of the disease, 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
700,000 cancer patients worldwide. Genomic Health is
expanding its test portfolio to include additional liquid- and
tissue-based tests, including the recently launched Oncotype
SEQ® Liquid Select assay. 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 to the company's beliefs
regarding its future performance, including its 2016 full year
guidance; the commercial performance of its tests; 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 has all rights
necessary to commercialize its tests; 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 June 30,
2016. 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, Oncotype IQ and Genomic
Prostate Score are trademarks or registered trademarks of Genomic
Health, Inc. All other trademarks and service marks are the
property of their respective owners.
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|
i Constant
currency was calculated by comparing the company's quarterly
average foreign exchange rates for the three and nine months ended
September 30, 2016 with the comparable periods of 2015.
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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,
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Product revenues –
United States
|
|
$
|
70,041
|
|
$
|
63,051
|
|
$
|
210,092
|
|
$
|
181,459
|
|
Product revenues –
Outside of the United States
|
|
12,095
|
|
10,503
|
|
34,824
|
|
30,866
|
|
Total product
revenues
|
|
|
82,136
|
|
|
73,554
|
|
|
244,916
|
|
|
212,325
|
|
Contract
revenues
|
|
122
|
|
-
|
|
210
|
|
-
|
|
Total
revenues
|
|
82,258
|
|
73,554
|
|
245,126
|
|
212,325
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
13,062
|
|
13,718
|
|
44,083
|
|
39,513
|
|
Research and
development
|
|
15,109
|
|
13,480
|
|
46,397
|
|
47,193
|
|
Selling and
marketing
|
|
38,838
|
|
35,369
|
|
116,327
|
|
107,964
|
|
General and
administrative
|
|
18,268
|
|
16,425
|
|
55,243
|
|
48,594
|
|
Total operating
expenses
|
|
85,277
|
|
78,992
|
|
262,050
|
|
243,264
|
|
Loss from
operations
|
|
(3,019)
|
|
(5,438)
|
|
(16,924)
|
|
(30,939)
|
|
Interest
income
|
|
117
|
|
54
|
|
282
|
|
163
|
|
Gain on sales of
marketable securities
|
|
-
|
|
-
|
|
2,009
|
|
-
|
|
Other income
(expense), net
|
|
(111)
|
|
(158)
|
|
(174)
|
|
(207)
|
|
Loss before income
taxes
|
|
(3,013)
|
|
(5,542)
|
|
(14,807)
|
|
(30,983)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit)
|
|
(193)
|
|
6,301
|
|
464
|
|
(410)
|
|
Net loss
|
|
$
|
(2,820)
|
|
$
|
(11,843)
|
|
$
|
(15,271)
|
|
$
|
(30,573)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.08)
|
|
$
|
(0.36)
|
|
$
|
(0.46)
|
|
$
|
(0.95)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
33,391
|
|
32,498
|
|
33,141
|
|
32,294
|
|
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended September 30, 2016, were
non-cash charges of $7.0 million, including $4.7 million of
stock-based compensation expense and $2.3 million of depreciation
and amortization expenses, compared with non-cash charges for the
same period in 2015 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 nine months ended September 30, 2016, were
non-cash charges of $20.8 million, including $14.1 million of
stock-based compensation expense and $6.7 million of depreciation
and amortization expenses, compared with non-cash charges for the
same period in 2015 of $17.2 million, including $12.1 million of
stock-based compensation expense and $5.1 million of depreciation
and amortization expenses.
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GENOMIC
HEALTH, INC.
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Condensed
Consolidated Balance Sheets
|
(In
thousands)
|
|
|
|
As
of
September 30,
2016
|
|
As of
December 31,
2015
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
33,999
|
|
$
|
32,533
|
|
Short-term marketable
securities (1)
|
|
64,602
|
|
62,410
|
|
Accounts receivable,
net
|
|
33,682
|
|
37,164
|
|
Prepaid expenses and
other current assets
|
|
12,066
|
|
10,843
|
|
Total current
assets
|
|
144,349
|
|
142,950
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
39,465
|
|
39,746
|
|
Other
assets
|
|
8,137
|
|
1,921
|
|
Total
assets
|
|
$
|
191,951
|
|
$
|
184,617
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,411
|
|
$
|
8,585
|
|
Accrued expenses and
other current liabilities
|
|
38,505
|
|
33,656
|
|
Deferred
revenues
|
|
28
|
|
431
|
|
Other
liabilities
|
|
3,606
|
|
2,410
|
|
Stockholders'
equity
|
|
144,401
|
|
139,535
|
|
Total liabilities and
stockholders' equity
|
|
$
|
191,951
|
|
$
|
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.
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|
|
(1)
|
Included in
short-term marketable securities as of September 30, 2016 and
December 31, 2015 was $15.0 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.