REDWOOD CITY, Calif.,
Aug. 4, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today reported
financial results and business progress for the quarter ended
June 30, 2015.
Revenue was $70.6 million in the
second quarter of 2015 compared with $70.5
million for the second quarter of 2014.
International revenue was $9.9
million in the second quarter of 2015, down from
$11.9 million in the second quarter
of 2014, and represented 14 percent of revenue in the quarter.
Although international test volume reached record levels, revenue
was impacted negatively from foreign exchange (FX) rate differences
due to the stronger dollar and by reimbursement timing in the
second quarter of 2015 compared with a year ago.
"In the second quarter we successfully executed on our key
growth drivers, including Oncotype DX® test growth
driven by DCIS, prostate cancer and international, all of which
reached record levels," said Kim Popovits, Chairman of the Board,
Chief Executive Officer and President of Genomic Health. "With this
momentum, anticipated Medicare revenue for our prostate cancer test
in the fourth quarter and continued reimbursement success across
markets and geographies, we believe we are well positioned to
deliver profitability and double-digit revenue growth by the end of
the year."
Net loss was $9.2 million for the
second quarter of 2015 compared with net loss of $4.6 million in the second quarter of 2014. Basic
and diluted net loss per share was $0.29 for the second quarter of 2015 compared
with basic and diluted net loss per share of $0.15 for the same period in 2014.
Additional Second Quarter 2015 and Six Months Ended
June 30, 2015, Financial
Results
Revenue for the six months ended June 30,
2015, was $138.8 million
compared with $137.5 million for the
six months ended June 30, 2014. On a
constant currency basis, revenue increased 2 percent compared with
the same period in the prior year.
Net loss was $18.7 million for the
six months ended June 30, 2015,
compared with a net loss of $12.1
million for the six months ended June
30, 2014.
Cash and cash equivalents and short-term marketable securities
at June 30, 2015, were $86.8 million exclusive of a corporate equity
investment, compared with $103.7
million at December 31,
2014.
More than 26,060 Oncotype DX test results were delivered in the
second quarter of 2015, compared with more than 24,050 test results
delivered in the same period in 2014, an increase of 8 percent.
International test results delivered grew 13 percent compared with
the prior year and represented approximately 21 percent of total
test volume in the second quarter of 2015.
2015 Financial Outlook
The Company is updating its financial guidance for the full year
ending December 31, 2015, to reflect
the estimated change in foreign currency rates:
- Revenue of $289 to $302 million (formerly
$292 to $305 million);
- Net loss between $19 and $26 million (formerly
$17 and $24
million), or basic net loss per share of
between $0.59 and $0.81; and
- Oncotype DX tests delivered of 102,000 to 109,000
(unchanged).
"While we are adjusting our financial guidance to reflect an
estimated $3 million impact on
revenue from the effect of foreign exchange rates, our expectations
regarding the level of Oncotype DX tests remain unchanged,
reflecting the strong growth across markets that we delivered in
the first half of the year," 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, issued a favorable
draft local coverage determination (LCD) recommending coverage of
the Oncotype DX prostate cancer test for qualified Medicare
patients throughout the United
States.
- Updates to both NCCN and the St. Gallen Breast Cancer
Guidelines continue to distinguish Oncotype DX as the only
multi-gene test validated to predict chemotherapy benefit for
patients with early-stage, estrogen receptor-positive, invasive
breast cancer.
- In the UK, finalized contracts with NHS England trusts covering
40 percent of the population to date for the Oncotype DX breast
cancer test.
- Expanded coverage of the Oncotype DX breast cancer test for
patients with 1-3 positive nodes to include nearly 30 million
additional lives through new policies with Aetna, Emblem Health and
Carefirst. This brings the total number of node-positive covered
lives to more than 130 million.
Pipeline, Presentations and Publications
- Breast Cancer Research and Treatment published results
from a second large clinical validation study of Oncotype DX in
patients with DCIS breast cancer, reconfirming that the DCIS Score™
is a strong independent predictor of local recurrence, which could
be either invasive breast cancer or DCIS.
- The Journal of Surgical Oncology published results of
the first decision impact study of the Oncotype DX DCIS Score,
showing that it changed 30 percent of treatment
recommendations.
- Presented positive results of two breast cancer analyses from
the Ontario population-based DCIS
study at the American Society of Clinical Oncology (ASCO) Annual
Meeting that reinforced the independent value of the Oncotype DX
DCIS Score. Additionally, researchers reported baseline
characteristics from the NCI-sponsored Trial Assigning
IndividuaLized Options for Treatment Rx, or TAILORx, that confirmed
the consistency of Oncotype DX Recurrence Score® results
across race and ethnicity.
- The Journal of Surgical Research published an
institutional review board-approved retrospective review concluding
that the menopausal status of women with invasive breast cancer
does not predict their Oncotype DX Recurrence Score and, therefore,
should not preclude use of the test in ER-positive, early-stage
breast cancer.
- Urology Practice published results from a chart review
study of more than 200 men with an Oncotype DX Genomic Prostate
Score (GPS) demonstrating greater physician recommendation of and
use of active surveillance in community clinical practices.
- Presented results of a study at the ASCO Annual Meeting
underscoring the importance of analyzing distinct genes across
multiple pathways with Oncotype DX GPS to provide clinical value
beyond currently available clinical risk factors.
- Presented positive results from five studies at the American
Urological Association (AUA) Annual Meeting, including a study led
by UCSF suggesting that the Oncotype DX GPS and Magnetic Resonance
Imaging (MRI) offer non-overlapping clinical insights.
- Presented positive proof-of-concept liquid biopsy data at the
American Association for Cancer Research (AACR) Precision Medicine
Series meeting demonstrating the ability to monitor bladder cancer
using a non-invasive urine test with accuracy comparable to
cystoscopy.
- Results of a study analyzing the cost-effectiveness of the
Oncotype DX breast cancer test in private hospitals in France were published, in which investigators
concluded that the test represents a cost-effective use of
healthcare resources.
- Results of the first prospective French decision impact study
of the Oncotype DX breast cancer test were published by French
investigators, showing that physicians changed their treatment
recommendations in 37 percent of patients, resulting in an overall
reduction in the recommended use of chemotherapy.
- Presented strongly positive data from the Japanese SUNRISE
colon cancer study at the 17th ESMO World Congress on
Gastrointestinal Cancer, validating the Oncotype DX colon cancer
test in Asian patients with Stage II and III disease treated with
surgery alone.
Conference Call Details
To access the live conference
call today, August 4, 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 78017757.
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 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 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 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 March 31,
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
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Product
revenues
|
|
$
|
70,619
|
|
$
|
70,477
|
|
$
|
138,771
|
|
$
|
137,479
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
13,033
|
|
12,207
|
|
25,795
|
|
24,262
|
|
Research and
development
|
|
14,595
|
|
12,630
|
|
33,713
|
|
26,636
|
|
Selling and
marketing
|
|
37,243
|
|
35,236
|
|
72,595
|
|
68,643
|
|
General and
administrative
|
|
16,580
|
|
15,015
|
|
32,169
|
|
29,743
|
|
Total operating
expenses
|
|
81,451
|
|
75,088
|
|
164,272
|
|
149,284
|
|
Loss from
operations
|
|
(10,832)
|
|
(4,611)
|
|
(25,501)
|
|
(11,805)
|
|
Interest
income
|
|
55
|
|
47
|
|
109
|
|
97
|
|
Other income
(expense), net
|
|
325
|
|
34
|
|
(49)
|
|
(192)
|
|
Loss before income
taxes
|
|
(10,452)
|
|
(4,530)
|
|
(25,441)
|
|
(11,900)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (benefit)
expense
|
|
(1,215)
|
|
88
|
|
(6,711)
|
|
163
|
|
Net loss
|
|
$
|
(9,237)
|
|
$
|
(4,618)
|
|
$
|
(18,730)
|
|
$
|
(12,063)
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.29)
|
|
$
|
(0.15)
|
|
$
|
(0.58)
|
|
$
|
(0.39)
|
|
Shares used in
computing basic and diluted net loss per share
|
|
32,324
|
|
31,333
|
|
32,191
|
|
31,211
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended June 30, 2015, were non-cash
charges of $5.7 million, including $4.0 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 $4.3 million of
stock-based compensation expense and $1.8 million of depreciation
and amortization expenses.
|
|
|
(2)
|
Included in operating
expenses for the six months ended June 30, 2015, were non-cash
charges of $11.5 million, including $8.1 million of stock-based
compensation expense and $3.4 million of depreciation and
amortization expenses, compared with non-cash charges for the same
period in 2014 of $12.1 million, including $8.6 million of
stock-based compensation expense and $3.5 million of depreciation
and amortization expenses.
|
GENOMIC
HEALTH, INC.
Condensed
Consolidated Balance Sheets
(In
thousands)
|
|
|
|
|
|
|
|
|
As of
June 30,
2015
|
|
As of
December 31,
2014
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
23,751
|
|
$
|
29,726
|
|
Short-term marketable
securities (1)
|
|
95,912
|
|
73,934
|
|
Accounts receivable,
net
|
|
32,900
|
|
34,916
|
|
Prepaid expenses and
other current assets
|
|
9,830
|
|
9,944
|
|
Total current
assets
|
|
162,393
|
|
148,520
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
28,560
|
|
21,860
|
|
Other
assets
|
|
1,572
|
|
15,541
|
|
Total
assets
|
|
$
|
192,525
|
|
$
|
185,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,961
|
|
$
|
6,987
|
|
Accrued expenses and
other current liabilities
|
|
32,689
|
|
31,016
|
|
Deferred
revenues
|
|
524
|
|
335
|
|
Other
liabilities
|
|
2,982
|
|
2,070
|
|
Stockholders'
equity
|
|
150,369
|
|
145,513
|
|
Total liabilities and
stockholders' equity
|
|
$
|
192,525
|
|
$
|
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 June 30, 2015, was $32.9
million of corporate equity securities, representing the Company's
investment in Invitae Corporation.
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/genomic-health-announces-second-quarter-2015-financial-results-and-reports-record-international-and-prostate-cancer-tests-delivered-300123608.html
SOURCE Genomic Health, Inc.