Genomic Health Announces Second Quarter 2014 Financial Results and Business
17% Increase in Test Volume, 11% Increase in Total Revenue and 29% Increase in
International Product Revenue Compared to Prior Year
Positive Topline Results from Additional, Large Clinical Validation Study of
Oncotype DX® Prostate Cancer Test with Multiple Clinical Endpoints
Positive Results from Second, Large Ductal Carcinoma In Situ (DCIS) Clinical
Validation Study Submitted for Presentation at the San Antonio Breast Cancer
Symposium in December
Conference Call Today at 4:30 p.m. ET
REDWOOD CITY, Calif., Aug. 7, 2014
REDWOOD CITY, Calif., Aug. 7, 2014 /PRNewswire/ -- Genomic Health, Inc.
(Nasdaq: GHDX) today reported financial results and business progress for the
quarter ended June 30, 2014.
Product revenue was $70.5 million in the second quarter of 2014, compared with
$63.7 million for the second quarter of 2013, an increase of 11 percent.
There was no contract revenue in either period.
International product revenue grew by 29 percent to $11.9 million compared to
the same period last year and represented 17 percent of product revenue in the
second quarter of 2014.
Net loss in the second quarter of 2014 was $4.6 million, compared with a net
loss of $3.0 million in the second quarter of 2013. Basic and diluted net
loss per share applicable to common stockholders was $0.15 for the second
quarter of 2014, compared with a basic and diluted net loss per share of $0.10
for the same period in 2013.
"In the second quarter, we delivered 17 percent growth in test volume and
double-digit revenue growth by increasing penetration of the U.S. invasive
breast cancer market and through continued strong international adoption and
reimbursement success," said Kim Popovits, Chairman of the Board, Chief
Executive Officer and President of Genomic Health. "Additionally, we delivered
strong prostate cancer test growth and announced positive results from an
additional large clinical validation study, which we believe will drive
reimbursement and further adoption of our test. We look forward to presenting
complete results from this study and the landmark DCIS breast cancer study
later this year."
Additional Second Quarter 2014 and Six Months Ended June 30, 2014 Financial
Total operating expenses for the second quarter of 2014 were $75.1 million,
compared with total operating expenses for the comparable period in 2013 of
Product revenue for the six months ended June 30, 2014 was $137.5 million,
compared with $126.4 million for the six months ended June 30, 2013, an
increase of 9 percent. Total revenue for the six months ended June 30, 2014
was $137.5 million, compared to $126.8 million for the comparable period in
Net loss was $12.1 million for the six months ended June 30, 2014, compared
with a net loss of $3.9 million for the six months ended June 30, 2013.
Cash and cash equivalents and short-term investments at June 30, 2014 were
$105.7 million, compared with $105.4 million at December 31, 2013.
In the second quarter, more than 24,050 Oncotype DX^® test results were
delivered, an increase of 17 percent, compared with more than 20,650 test
results delivered in the same period in 2013. International test results grew
32 percent during the quarter and represented approximately 20 percent of
total test volume in the quarter.
"Our first half net loss reflects planned investments in the international and
prostate cancer markets," said Brad Cole, Chief Operating Officer and Chief
Financial Officer of Genomic Health. "We anticipate planned investments in
DCIS, prostate and international markets to continue through the end of the
year, resulting in second half net losses similar to the first half."
Recent Business Highlights:
Oncotype DX Commercial Progress
oIn Canada, established Oncotype DX breast cancer test coverage for an
additional 3.6 million lives in the province of Alberta, bringing the
total lives covered to more than 86 percent of the country's population.
oIn Spain, the Agency for Health Technology Assessment of Andalusia (AETSA)
published the Evaluation Report of Genomic Platforms, recommending
Oncotype DX as the only breast cancer test to support therapeutic
decision-making in patients with early-stage, hormone receptor-positive,
invasive breast cancer.
oIn Mexico, private health insurer AXA granted reimbursement for the
Oncotype DX breast cancer test, covering 1.2 million lives.
oAnnounced that the Oncotype DX breast cancer test was the first multi-gene
test for cancer management to be included in the National Institutes of
Health's genetic testing registry.
oEstablished Medicaid coverage in three additional states for the Oncotype
DX breast cancer test.
Pipeline, Presentations and Publications
oAnnounced positive preliminary results from an additional independent
clinical validation study conducted by the Center for Prostate Disease
Research (CPDR), demonstrating that the Oncotype DX Genomic Prostate Score
(GPS) predicts multiple clinical endpoints related to disease
aggressiveness in men with low- and intermediate-risk prostate cancer.
This study validated the Oncotype DX prostate cancer test as a predictor
of biochemical recurrence, a rise in prostate-specific antigen (PSA)
following surgery, which is a longer-term measure of outcomes for
aggressive disease. It also reconfirmed the test's ability to predict
adverse pathology from the biopsy, as previously demonstrated in a
published validation study performed by the University of California, San
oAnnounced positive preliminary results from a large, independent clinical
validation study of Oncotype DX in patients with a pre-invasive form of
breast cancer, also known as DCIS (ductal carcinoma in situ). Complete
data has been submitted for presentation at the 2014 San Antonio Breast
oEuropean Urology published groundbreaking results from three studies
demonstrating that the Oncotype DX prostate cancer test predicts
aggressiveness at diagnosis and significantly increases the number of
low-risk patients who can confidently choose active surveillance.
oPresented results from nine abstracts at the American Society of Clinical
Oncology^® (ASCO^®) Annual Meeting, including data demonstrating that the
Oncotype DX breast cancer test predicts late recurrence five to 15 years
out; the unique, practice-changing impact of Oncotype DX to optimize
cancer care; and the importance of utilizing multiple biological pathways
to predict tumor behavior in prostate and renal cancers.
oPresented results of a new analysis suggesting that the Oncotype DX
prostate cancer test predicts recurrence risk after prostatectomy,
regardless of post-surgery treatment, at the American Urological
Association (AUA) Annual Meeting.
oReceived acceptance to present one study at the upcoming ASCO Breast
Cancer Symposium September 4-6.
oReceived acceptance to present two studies at the upcoming American
Society of Radiation Oncology^® (ASTRO^®) Meeting September 14-17.
oReceived acceptance to present eight studies in multiple tumor types at
the upcoming European Society of Medical Oncology^® (ESMO^®) Congress
Conference Call Details
To access the live conference call today, August 7 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 66377262. 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 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 datainto clinically-actionable results for treatment planning
throughout the cancer patient's journey, from screening and surveillance,
through diagnosis, treatment selection and monitoring. Genomic Health's lead
product, the Oncotype DX® breast cancer test, has been shown to predict the
likelihood of chemotherapy benefit as well as recurrence in invasive breast
cancer and has been shown to predict the likelihood of recurrence in ductal
carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic
Health provides the Oncotype DX colon cancer test, the first multi-gene
expression test developed for the assessment of risk of recurrence in patients
with stage II and stage III disease, and the Oncotype DX prostate cancer test,
which predicts disease aggressiveness in men with low risk disease. As of June
30, 2014, more than 19,000 physicians in over 70 countries had ordered more
than 465,000 Oncotype DX tests. 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. To learn more about OncotypeDX tests, visit:
www.OncotypeDX.com, www.mybreastcancertreatment.org and
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 test; the company's
expectations regarding reporting study results; the company's intent to
continue its investments in DCIS, prostate cancer and international markets;
the company's expectations regarding second half financial 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 March 31, 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
GENOMIC HEALTH, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
2014 2013 2014 2013
Product revenues $ 70,477 $ 63,691 $ 137,479 $ 126,400
Contract revenues - - - 385
Total revenues 70,477 63,691 137,479 126,785
OPERATING EXPENSES (1)(2):
Cost of product revenues 12,207 10,757 24,262 20,503
Research and development 13,295 13,800 27,976 27,463
Selling and marketing 34,571 28,135 67,303 55,574
General and administrative 15,015 13,910 29,743 27,045
Total operating expenses 75,088 66,602 149,343 130,585
Loss from operations (4,611) (2,911) (11,805) (3,800)
Interest income 47 57 97 122
Other income (expense), net 34 (85) (192) (91)
Loss before income taxes (4,530) (2,939) (11,900) (3,769)
Income tax expense 88 55 163 108
Net loss $ (4,618) $ (2,994) $ (12,063) $ (3,877)
Basic and diluted net loss per $ (0.15) $ (0.10) $ (0.39) $ (0.13)
Shares used in computing basic 31,333 30,302 31,211 30,236
and diluted net lossper share
Included in operating expenses for the three months ended June 30, 2014
were non-cash charges of $6.1 million, including $4.3 million of
stock-based compensation expense and $1.8 million of depreciation and
(1) amortization expenses, compared with non-cash charges for the same period
in 2013 of $6.1 million, including $4.4 million of stock-based
compensation expense and $1.7 million of depreciation and amortization
Included in operating expenses for the six months ended June 30, 2014 were
non-cash charges of $12.1 million, including $8.6 million of stock-based
(2) compensation expense and $3.5 million of depreciation and amortization
expenses, compared with non-cash charges for the same period in 2013 of
$11.6 million, including $8.5 million of stock-based compensation expense
and $3.1 million of depreciation and amortization expenses.
GENOMIC HEALTH, INC.
Condensed Consolidated Balance Sheets
As of December31,
Cash and cash equivalents $ 32,494 $ 33,279
Short-term marketable securities 73,209 72,071
Accounts receivable, net 31,771 29,446
Prepaid expenses and other current assets 9,014 10,196
Total current assets 146,488 144,992
Property and equipment, net 17,342 18,290
Other assets 14,120 13,752
Total assets $ 177,950 $ 177,034
Accounts payable $ 5,560 $ 5,160
Accrued expenses and other current liabilities 26,581 24,086
Deferred revenues 273 586
Other liabilities 2,083 2,221
Stockholders' equity 143,453 144,981
Total liabilities and stockholders' equity $ 177,950 $ 177,034
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 Form 10-K for the year ended December 31, 2013.
Genomic Health, Inc. logo.
Logo - http://photos.prnewswire.com/prnh/20130425/SF01493LOGO
SOURCE Genomic Health, Inc.
Contact: Investors: Emily Faucette, Genomic Health, 650-569-2824,
firstname.lastname@example.org, or Media: Victoria Steiner, Genomic Health,
Press spacebar to pause and continue. Press esc to stop.