REDWOOD CITY, Calif.,
May 7, 2019 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today
reported financial results and business progress for the quarter
ended March 31, 2019.
"In the first quarter of 2019, we delivered more than 17 percent
overall revenue growth and $13.0
million in profit driven by significant growth across all
key product areas," said Kim
Popovits, chairman of the board, chief executive officer and
president of Genomic Health. "Our first quarter performance
was very strong, based in part on the impact of the landmark
TAILORx trial results, which are continuing to drive increased
Oncotype DX Breast Recurrence Score test usage both in the United States and globally. We expect to
achieve double-digit revenue growth for the year with continued
growth across key products and look forward to the national
reimbursement decision in Germany
for the Oncotype DX breast cancer test."
First Quarter Financial Results
Total revenue for the first quarter of 2019 was $108.8 million, compared with $92.6 million for the first quarter of 2018, an
increase of 17.4 percent, and an increase of 18.0 percent on a
non-GAAP constant currency basis. U.S. product revenue was
$91.0 million for the first quarter
of 2019, compared with $78.9 million
for the first quarter of 2018, an increase of 15.4 percent.
Revenue delivered across key product areas was as follows:
- U.S. invasive breast revenue from Oncotype DX Breast Recurrence
Score® tests was $79.8
million for the first quarter of 2019, compared with
$71.0 million for the first quarter
of 2018, an increase of 12.5 percent.
- U.S. prostate test revenue from Oncotype DX® Genomic
Prostate Score® (GPS™) tests was $8.5 million for the first quarter of 2019,
compared with $5.8 million for the
first quarter of 2018, an increase of 46.6 percent.
- International product revenue for the first quarter of 2019 was
$17.8 million, compared with
$13.8 million for the first quarter
of 2018, an increase of 29.0 percent, and an increase of 32.9
percent on a non-GAAP constant currency basis.
Net income was $13.0 million, or
$0.35 and $0.34 per share on a basic and diluted basis,
respectively, for the first quarter of 2019, an improvement of
$16.8 million, compared with a net
loss of $3.8 million, or $0.11 per share on a basic and diluted basis, for
the first quarter of 2018. Operating income was $11.5 million for the first quarter of 2019, an
improvement of $15.9 million,
compared with an operating loss of $4.4
million for the first quarter of 2018.
More than 37,580 Oncotype™ test results were
delivered in the first quarter of 2019, an increase of 15.9
percent, compared with more than 32,440 test results delivered in
the same period in 2018. Tests delivered across key product areas
was as follows:
- Oncotype DX Breast Recurrence Score tests delivered in the U.S.
grew 9.4 percent in the first quarter of 2019, compared with the
same period in 2018.
- Oncotype DX Genomic Prostate Score tests delivered in the U.S.
grew 24.5 percent in the first quarter of 2019, compared with the
same period in 2018.
- Oncotype DX international tests delivered grew 28.1 percent in
the first quarter of 2019, compared with the same period in 2018
and represented approximately 25 percent of total test volume in
the first quarter of 2019.
Recent Business Highlights
- Presented results from five studies at the 16th St.
Gallen International Breast Cancer Conference, including real-world
evidence that reinforces the treatment paradigm established by the
TAILORx trial. Additionally, two decision impact studies from the
UK and the Czech Republic
highlighted the value of Oncotype DX in personalizing and improving
the quality of clinical decisions in patients with early-stage
breast cancer, including those with node positive disease .
- Multiple private insurers established new coverage for the
Oncotype DX Genomic Prostate Score test, bringing the total number
of U.S. covered lives to more than 114 million, including
Medicare.
- First private insurer established reimbursement for the
Oncotype DX AR-V7 Nucleus Detect™ test, bringing the total number
of U.S. covered lives to more than 61 million, including
Medicare.
- The National Comprehensive Cancer Network (NCCN) strengthened
its prostate cancer guidelines, recommending the consideration of
AR-V7 testing in metastatic castrate resistant prostate cancer
(mCRPC) patients following abiraterone/enzalutamide to help guide
the selection of further therapy.
Conference Call Details
To access the live conference call today, May 7, 2019, 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 call ID is 6535029. 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. Please connect to the website at
least 15 minutes prior to the presentation 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,
including 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 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 over 1 million cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid- and tissue-based tests, including the
Oncotype DX® AR-V7 Nucleus
Detect™ test. 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 the company's beliefs
regarding its revenue growth for the remainder of 2019 and the
drivers of growth; the commercial performance of its tests; the
continued favorable impact of TAILORx results on test revenue and
increased global test adoption in 2019; 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
expectations regarding additional public and private reimbursement
coverage for our tests worldwide and the ability of additional
coverage to result in additional revenue. 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 risk
that the company may not achieve revenue growth for the remainder
of 2019; 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 commercial success of any
collaborations entered into by the company; 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
Annual Report on Form 10-K for the year ended December 31, 2018. 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, Breast
Recurrence Score, DCIS Score, Genomic Prostate Score, GPS, Oncotype
DX AR-V7 Nucleus Detect, 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)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2019
|
|
2018
|
REVENUES:
|
|
|
|
|
|
|
Product revenues -
United States
|
|
$
|
91,006
|
|
$
|
78,867
|
Product revenues -
Outside of the United States
|
|
|
17,751
|
|
|
13,758
|
Total product
revenues
|
|
|
108,757
|
|
|
92,625
|
Contract
revenues
|
|
|
12
|
|
|
—
|
Total
revenues
|
|
|
108,769
|
|
|
92,625
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1):
|
|
|
|
|
|
|
Cost of product
revenues
|
|
|
17,008
|
|
|
18,733
|
Research and
development
|
|
|
15,054
|
|
|
16,807
|
Selling and
marketing
|
|
|
45,348
|
|
|
41,755
|
General and
administrative
|
|
|
19,820
|
|
|
19,718
|
Total operating
expenses
|
|
|
97,230
|
|
|
97,013
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
11,539
|
|
|
(4,388)
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,151
|
|
|
417
|
Unrealized gain
(loss) on investments, net
|
|
|
449
|
|
|
127
|
Other income
(expense), net
|
|
|
127
|
|
|
309
|
Income (loss) before
income taxes
|
|
|
13,266
|
|
|
(3,535)
|
Income tax
expense
|
|
|
267
|
|
|
240
|
Net income
(loss)
|
|
$
|
12,999
|
|
$
|
(3,775)
|
Basic net income
(loss) per share
|
|
$
|
0.35
|
|
$
|
(0.11)
|
Diluted net income
(loss) per share
|
|
$
|
0.34
|
|
$
|
(0.11)
|
Shares used in
computing basic net income (loss) per share
|
|
|
36,719
|
|
|
35,198
|
Shares used in
computing diluted net income (loss) per share.
|
|
|
38,764
|
|
|
35,198
|
_________________
(1)
|
Included in operating
expenses for the three months ended March 31, 2019, were
non-cash charges of $9.7 million, including $6.3 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 2018 of $8.3 million, including
$5.2 million of stock-based compensation expense and
$3.1 million of depreciation and amortization expenses.
|
GENOMIC
HEALTH, INC.
Condensed
Consolidated Balance Sheets
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
|
March
31,
|
|
December 31,
|
|
|
|
2019
|
|
2018
|
|
|
|
(Unaudited)
|
|
(1)
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
101,406
|
|
$
|
61,645
|
|
Short-term marketable
securities (2)
|
|
|
104,551
|
|
|
148,149
|
|
Accounts receivable,
net
|
|
|
59,248
|
|
|
51,531
|
|
Prepaid expenses and
other current assets
|
|
|
15,446
|
|
|
13,511
|
|
Total current
assets
|
|
|
280,651
|
|
|
274,836
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
39,913
|
|
|
39,532
|
|
Operating lease
right-of-use assets
|
|
|
53,295
|
|
|
—
|
|
Long-term marketable
securities
|
|
|
—
|
|
|
4,066
|
|
Other
assets
|
|
|
18,931
|
|
|
15,938
|
|
Total
assets
|
|
$
|
392,790
|
|
$
|
334,372
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
9,290
|
|
$
|
8,849
|
|
Accrued expenses and
other current liabilities
|
|
|
35,701
|
|
|
50,927
|
|
Current portion of
operating lease liabilities
|
|
|
4,495
|
|
|
—
|
|
Operating lease
liabilities
|
|
|
53,482
|
|
|
—
|
|
Other
liabilities
|
|
|
1,941
|
|
|
4,436
|
|
Stockholders'
equity
|
|
|
287,881
|
|
|
270,160
|
|
Total liabilities and
stockholders' equity
|
|
$
|
392,790
|
|
$
|
334,372
|
|
_________________
(1)
|
The condensed
consolidated balance sheet at December 31, 2018, 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, 2018.
|
|
|
(2)
|
Included in
short-term marketable securities as of March 31, 2019, and
December 31, 2018, is $3.5 million and $3.1 million,
respectively, of corporate equity securities, representing the
company's investment in Biocartis N.V.
|
GENOMIC HEALTH,
INC.
GAAP to Non-GAAP
Reconciliations
(In
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2019
|
|
2018
|
|
Income (loss) from
operations reconciliation:
|
|
|
|
|
|
|
|
GAAP income (loss)
from operations
|
|
$
|
11,539
|
|
$
|
(4,388)
|
|
Cost of product
revenues – cessation of Oncotype SEQ
|
|
|
—
|
|
|
3,576
|
|
Research and
development – cessation of Oncotype SEQ
|
|
|
—
|
|
|
3,063
|
|
Selling and marketing
– cessation of Oncotype SEQ
|
|
|
—
|
|
|
995
|
|
General and
administrative – cessation of Oncotype SEQ
|
|
|
—
|
|
|
909
|
|
Non-GAAP income
(loss) from operations
|
|
$
|
11,539
|
|
$
|
4,155
|
|
|
|
|
|
|
|
|
|
Net income (loss)
reconciliation:
|
|
|
|
|
|
|
|
GAAP net income
(loss)
|
|
$
|
12,999
|
|
$
|
(3,775)
|
|
Cost of product
revenues – cessation of Oncotype SEQ
|
|
|
—
|
|
|
3,576
|
|
Research and
development – cessation of Oncotype SEQ
|
|
|
—
|
|
|
3,063
|
|
Selling and marketing
– cessation of Oncotype SEQ
|
|
|
—
|
|
|
995
|
|
General and
administrative – cessation of Oncotype SEQ
|
|
|
—
|
|
|
909
|
|
Non-GAAP net income
(loss)
|
|
$
|
12,999
|
|
$
|
4,768
|
|
GENOMIC HEALTH,
INC.
Non-GAAP Constant
Currency Reconciliations
(In
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2019
|
|
2018
|
|
Constant currency
reconciliations:
|
|
|
|
|
|
|
|
International
Revenue:
|
|
|
|
|
|
|
|
International revenue
(1)
|
|
$
|
17,751
|
|
$
|
13,758
|
|
Currency
exchange adjustments (2)
|
|
|
531
|
|
|
—
|
|
Non-GAAP
International revenue
|
|
$
|
18,282
|
|
$
|
13,758
|
|
Period
over period constant currency increase
|
|
|
4,524
|
|
|
|
|
Period
over period constant currency increase percentage
|
|
|
33%
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue:
|
|
|
|
|
|
|
|
Total revenue
(1)
|
|
$
|
108,769
|
|
$
|
92,625
|
|
Currency
exchange adjustments (2)
|
|
|
531
|
|
|
—
|
|
Non-GAAP total
revenue
|
|
$
|
109,300
|
|
$
|
92,625
|
|
Period
over period constant currency increase
|
|
|
16,675
|
|
|
|
|
Period
over period constant currency increase percentage
|
|
|
18%
|
|
|
|
|
_________________
(1)
|
For the three months
ended March 31, 2019, compared to the same period ended
March 31, 2018, the increase in international revenue was
29%.
|
|
|
(2)
|
Constant currency is
a non-GAAP measure that is calculated by comparing the company's
quarterly average foreign exchange rates for the three months ended
March 31, 2019 and 2018. The constant currency disclosures
take current local currency revenue and translate it into U.S.
dollars based upon the foreign currency exchange rates used to
translate the local currency revenue for the applicable comparable
period in the prior year, rather than the actual exchange rates in
effect during the current period. It does not include any other
effect of changes in foreign currency rates on the company's
results or business.
|
GENOMIC HEALTH,
INC.
Adjusted EBITDA
Reconciliations
(In
thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2019
|
|
2018
|
|
Adjusted EBITDA
reconciliation:
|
|
|
|
|
|
|
|
GAAP income (loss)
from operations
|
|
$
|
11,539
|
|
$
|
(4,388)
|
|
Add:
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
6,281
|
|
|
5,186
|
|
Depreciation and amortization
|
|
|
3,412
|
|
|
3,155
|
|
Adjusted EBITDA
|
|
$
|
21,232
|
|
$
|
3,953
|
|
|
|
|
|
|
|
|
|
GHDX-F
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SOURCE Genomic Health, Inc.