REDWOOD CITY, Calif.,
Feb. 20, 2019 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today reported
financial results and business progress for the quarter and year
ended December 31, 2018.
"2018 was a record year for Genomic Health. We delivered
$394.1 million in revenue and
non-GAAP net income of $39.7 million,
exceeding expectations for the year. In December, we achieved a
significant milestone delivering our one millionth Oncotype DX
tests to cancer patients worldwide," said Kim Popovits, chairman of the board, chief
executive officer and president of Genomic Health.
"Additionally, positive results from the landmark NCI-sponsored
TAILORx trial, published in June, elevated Oncotype DX to a new
global standard of care for early-stage breast cancer. In 2019, we
expect this momentum to continue as we increase penetration of our
Oncotype DX tests both in the U.S. and key European markets and
broaden global access with national reimbursement progress. We also
expect to continue the expansion and diversification of our
portfolio through multiple platforms and partners for longer-term
growth."
Full Year 2018 Financial Results
Total revenue for 2018 was $394.1
million, compared with pre-606 adjusted revenue* of
$334.0 million for 2017, an increase
of 18 percent. Reported revenue was $340.8
million for 2017.
U.S. product revenue was $334.7
million for the full year 2018, compared with pre-606
adjusted revenue* of $281.6 million
for 2017, an increase of 19 percent. U.S. product reported revenue
was $287.4 million for 2017. U.S.
invasive breast revenue from Oncotype DX Breast Recurrence
Score® tests was $299.4
million for 2018, compared with pre-606 adjusted revenue* of
$254.0 million for 2017, an increase
of 18 percent. U.S. invasive breast reported revenue was
$259.7 million for 2017. U.S.
prostate test revenue from Oncotype DX® Genomic Prostate
Score® (GPS™) tests was $26.8 million in 2018, compared with pre-606
adjusted revenue* of $17.9 million in
2017, an increase of 50 percent. U.S. prostate test reported
revenue from GPS tests was $17.9
million in 2017.
International product revenue for 2018 was $59.4 million, compared with pre-606 adjusted
revenue* of $52.0 million for 2017,
an increase of 14 percent, and an increase of 12 percent on a
non-GAAP constant currency basis. International product reported
revenue was $53.1 million for
2017.
GAAP net income was $25.7 million,
or $0.72 and $0.68 per share on a basic and diluted basis,
respectively, for 2018, an improvement of $29.6 million, compared with a net loss of
$3.9 million, or $0.11 per share on a basic and diluted basis, for
2017. GAAP operating income was $23.9
million for 2018, an improvement of $30.4 million, compared with an operating loss of
$6.5 million for 2017.
Non-GAAP net income was $39.7
million for 2018, an improvement of $41.3 million, compared with a $1.6 million non-GAAP net loss for 2017. Non-GAAP
operating income was $38.8 million
for 2018, an improvement of $41.0
million, compared with a non-GAAP operating loss of
$2.2 million for 2017.
2019 Financial Guidance
"We have entered 2019 with strong momentum in our business and
expect to deliver revenue growth between 11 and 14 percent and
significantly greater improvement in profitability for the full
year with continued operating leverage," said Brad Cole, chief financial officer of Genomic
Health. "In 2019, operating margin expansion is expected to deliver
net income growth between 35 and 50 percent for the year on a
non-GAAP basis."
The company is providing the following guidance for the full
year ending December 31, 2019:
|
|
Low
|
|
High
|
Revenue(1)
|
|
$
436
|
|
$
448
|
Revenue
Growth
|
|
11%
|
|
14%
|
|
|
|
|
|
Net Income (GAAP)
(1)
|
|
$
48
|
|
$
54
|
GAAP Diluted EPS
(2)
|
|
$
1.23
|
|
$
1.38
|
|
|
|
|
|
Net Income (Non-GAAP)
(1) (3)
|
|
$
54
|
|
$
60
|
Non-GAAP Diluted EPS
(2)
|
|
$
1.38
|
|
$
1.54
|
|
|
|
|
|
|
|
|
(1)
|
In
millions.
|
(2)
|
Based on 39 million
estimated shares outstanding for Diluted EPS.
|
(3)
|
Non-GAAP net income
excludes charges for clinical and commercial development milestone
payments; changes in fair value of investments and acquisition
fees.
|
Additional 2018 Full Year and Fourth Quarter Financial
Results
Total revenue was $104.6 million in
the fourth quarter of 2018, compared with pre-606 adjusted revenue*
of $85.7 million for the fourth
quarter of 2017, an increase of 22 percent. Revenue growth in the
fourth quarter would have been 18 percent excluding $3.5 million to reflect ASC-606 portfolio
adjustments. Reported revenue was $87.5
million in the fourth quarter of 2017.
U.S. product revenue was $88.6
million in the fourth quarter of 2018, compared with pre-606
adjusted revenue* of $72.0 million
for the fourth quarter of 2017, an increase of 23 percent. U.S.
product reported revenue was $73.5
million in the fourth quarter of 2017. U.S. invasive breast
revenue from Oncotype DX Breast Recurrence Score tests was
$79.3 million in the fourth quarter
of 2018, compared with pre-606 adjusted revenue* of $64.7 million in the fourth quarter of 2017, an
increase of 22 percent. U.S. invasive breast reported revenue was
$66.2 million in the fourth quarter
of 2017. U.S. prostate test revenue from Oncotype DX GPS tests was
$7.4 million in the fourth quarter of
2018, compared with pre-606 adjusted revenue* of $5.0 million in the fourth quarter of 2017, an
increase of 48 percent. U.S. prostate test reported revenue
from GPS tests was $5.0 million in
the fourth quarter of 2017.
International product revenue was $16.0
million in the fourth quarter of 2018, compared with pre-606
adjusted revenue* of $13.4 million
for the fourth quarter of 2017, an increase of 19 percent, and a 21
percent increase on a non-GAAP constant currency basis.
International product reported revenue was $13.7 million in the fourth quarter of 2017.
GAAP net income was $8.9 million,
or $0.25 and $0.23 per share on a basic and diluted basis,
respectively, in the fourth quarter of 2018, an improvement of
$7.0 million, compared with
$1.9 million, or $0.05 per share on a basic and diluted basis, in
the fourth quarter of 2017. GAAP operating income was $9.4 million in the fourth quarter of 2018, an
improvement of $7.3 million, compared
with $2.1 million in the fourth
quarter of 2017.
Non-GAAP net income was $12.4
million in the fourth quarter of 2018, an improvement of
$9.5 million, compared with non-GAAP
net income of $2.9 million in the
fourth quarter of 2017. Non-GAAP operating income was $12.3 million in the fourth quarter of 2018,
compared with a non-GAAP operating income of $3.1 million in the fourth quarter of 2017.
More than 35,530 Oncotype™ test results were
delivered in the fourth quarter of 2018, an increase of 11 percent,
compared with more than 31,990 test results delivered in the same
period in 2017. Oncotype DX Breast Recurrence Score tests delivered
in the U.S. grew 9 percent in the fourth quarter of 2018, compared
with the same period in 2017. Oncotype DX GPS tests delivered in
the U.S. grew 19 percent in the fourth quarter of 2018, compared
with the same period in 2017. Oncotype DX international tests
delivered grew 15 percent in the fourth quarter of 2018, compared
with the same period in 2017 and represented approximately 24
percent of total test volume in the quarter.
More than 136,380 Oncotype test results were delivered for the
year ended December 31, 2018, an
increase of 8 percent, compared with more than 126,730 test results
delivered in the same period in 2017. Oncotype DX Breast Recurrence
Score tests delivered in the U.S. grew 7 percent in 2018 compared
to the prior year. Oncotype DX GPS tests delivered in the U.S. grew
23 percent in 2018 compared to the prior year. Oncotype DX
international tests delivered grew 4 percent in 2018 compared to
the prior year and represented approximately 24 percent of total
test volume in 2018.
Cash and cash equivalents and short-term marketable securities
at December 31, 2018, were
$209.8 million, an increase of
$80.2 million compared with
$129.6 million at December 31, 2017.
Recent Business Highlights
- Delivered, in collaboration with physicians around the world,
more than 1 million Oncotype DX tests to cancer patients worldwide
since the first test was made available to patients in 2004. To
date, more than 53,000 physicians across 90 countries have used
Oncotype DX to optimize treatment decisions for their breast,
prostate and colon cancer patients, improving outcomes and saving
more than $5 billion in healthcare
costs.
- Expanded exclusive collaboration with Biocartis Group NV to
include urology for the anticipated development of an in vitro
diagnostic version of the Oncotype DX Genomic Prostate Score test
on Biocartis' Idylla™ platform.
- The U.K.'s National Institute for Health and Care Excellence
(NICE) issued updated guidance again recommending the Oncotype DX
Breast Recurrence Score test for use in clinical practice to guide
adjuvant chemotherapy treatment decisions and expanding its prior
recommendation to now include patients with micrometastases.
- The Breast published results from a French prospective
decision impact study on the real-life utilization of the Oncotype
DX Breast Recurrence Score test in clinical practice,
demonstrating a 36 percent reduction in chemotherapy use.
Consistent with other decision impact studies worldwide, these
results highlight the value and need for broader patient access in
France.
- Nature Partner Journals (NPJ) Breast
Cancer published a new analysis of the randomized NSABP
B-20 study confirming patients with Oncotype DX Breast Recurrence
Score results greater than 25 receive life-saving benefit from
chemotherapy, reinforcing the conclusions of the landmark TAILORx
study.
- Presented results from two Oncotype DX studies at the 2018 San
Antonio Breast Cancer Symposium reinforcing the real-world value of
the Oncotype DX Breast Recurrence Score test in optimizing
treatment and outcomes in breast cancer patients regardless of age
or race.
- Received acceptance to present five studies at the
16th St. Gallen International Breast Cancer Conference
in March 2019.
- Urology published results from a multi-center study
establishing Oncotype DX as the first genomic prostate cancer test
with prospective validation for predicting adverse pathology to
identify patients for active surveillance.
- Presented results from multiple studies in men on active
surveillance at the 2019 Genitourinary Cancers Symposium
demonstrating association between the Oncotype DX GPS test and
adverse pathology, underscoring its value in identifying patients
who will ultimately require surgery due to disease
progression.
*Pre-606 Adjusted Product Revenue
Effective January 1, 2018, the
company adopted the new ASC 606 accounting standard for revenue,
using the modified retrospective method, which applies the new
standard prospectively and does not impact prior years' financial
statements. Since the as-reported 2017 quarterly and annual
financial statements will not be restated to reflect the new
accounting standard, the company has provided a supplemental
financial schedule in the non-GAAP tables at the end of this press
release, reflecting an estimate of revenue as if the new standard
had been applied to the historical 2017 product revenue portion of
revenue as of January 1, 2017,
referred to herein as "pre-606 adjusted revenue."
Non-GAAP Disclosure
The company makes reference in this press release to "non-GAAP
operating income (loss)," which excludes 2018 expenses resulting
from the restructuring charges for the cessation of the Oncotype
SEQ® Liquid Select™ test product development
and commercialization activities in the first quarter of 2018, the
cessation of its collaboration with Cleveland Diagnostics in the
second quarter of 2018, the expenses for milestone payments to
Biocartis N.V. (Biocartis) in the second and third quarters of
2018, as well as the payment to Biocartis for exercising its option
to expand the collaboration to include urology in the fourth
quarter of 2018. Additionally, the company references "non-GAAP net
income (loss)," which also excludes fair value adjustments related
to its collaborations with Biocartis and Epic Sciences, and the
gain on sale of marketable securities in the first quarter of 2017.
The company believes that excluding these items and their related
tax effects from its financial results reflects operating results
that are more indicative of the company's ongoing operating
performance while improving comparability to prior periods, and, as
such, may provide investors with an enhanced understanding of the
company's past financial performance and prospects for the future.
The company also considers the impact of foreign currency exchange
rates on its global business as described in the constant currency
table accompanying this press release. The company's management
uses such non-GAAP measures internally to evaluate and assess its
core operations and to make ongoing operating decisions. This
information is not intended to be considered in isolation or as a
substitute for income (loss) from operations or net income (loss)
information prepared in accordance with GAAP. An explanation and
reconciliation of the non-GAAP financial measures to the most
directly comparable GAAP financial measures is included in the
tables accompanying this press release.
Conference Call Details
To access the live conference call today, February 20, 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 8989205. 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 long-term success; financial guidance and future
profitability; revenue, net income and operating margin growth and
operating leverage for the full year 2019; the commercial
performance of its tests; the continued impact of TAILORx results
on revenue in 2019 domestically and abroad; the attributes and
focus of the company's product pipeline; the ability of any
potential tests the company may develop to optimize cancer
treatment; the ability of the company to develop and commercialize,
and collaborate with third parties to commercialize, additional
tests in the future; the ability of the company to increase
worldwide access through the development of an in vitro diagnostic
version of its tests; expectations regarding additional public and
private reimbursement coverage for its tests worldwide and the
ability of additional coverage to result in additional revenue; the
company's methodology for calculating financial performance under
the new ASC 606 accounting standard as compared against prior
periods under the previously applicable ASC 605 accounting standard
. 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 its 2019
guidance estimates and the assumptions underlying such guidance;
the successful completion of the annual audit of the company's
financial statements; 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 Quarterly Report on Form 10-Q for the quarter
ended September 30, 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, Oncotype SEQ, Liquid Select, 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
|
|
Year
Ended
|
|
|
December 31,
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues -
United States
|
|
$
|
88,628
|
|
$
|
73,486
|
|
|
334,682
|
|
$
|
287,363
|
Product revenues -
Outside of the United States
|
|
|
15,981
|
|
|
13,678
|
|
|
59,429
|
|
|
53,088
|
Total product
revenues
|
|
|
104,609
|
|
|
87,164
|
|
|
394,111
|
|
|
340,451
|
Contract
revenues
|
|
|
—
|
|
|
299
|
|
|
—
|
|
|
299
|
Total
revenues
|
|
|
104,609
|
|
|
87,463
|
|
|
394,111
|
|
|
340,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
(1)(2):
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
|
15,692
|
|
|
13,814
|
|
|
64,326
|
|
|
54,718
|
Research and
development
|
|
|
16,648
|
|
|
14,944
|
|
|
64,200
|
|
|
62,811
|
Selling and
marketing
|
|
|
42,636
|
|
|
36,536
|
|
|
164,779
|
|
|
157,001
|
General and
administrative
|
|
|
20,207
|
|
|
20,019
|
|
|
76,910
|
|
|
72,670
|
Total operating
expenses
|
|
|
95,183
|
|
|
85,313
|
|
|
370,215
|
|
|
347,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
9,426
|
|
|
2,150
|
|
|
23,896
|
|
|
(6,450)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
892
|
|
|
307
|
|
|
2,385
|
|
|
934
|
Unrealized gain
(loss) on investments, net
|
|
|
(662)
|
|
|
—
|
|
|
875
|
|
|
7
|
Gain on sales of
marketable securities
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,807
|
Other income
(expense), net
|
|
|
(332)
|
|
|
(436)
|
|
|
(232)
|
|
|
349
|
Income (loss) before
income taxes
|
|
|
9,324
|
|
|
2,021
|
|
|
26,924
|
|
|
(2,353)
|
Income tax
expense
|
|
|
414
|
|
|
142
|
|
|
1,247
|
|
|
1,504
|
Net income
(loss)
|
|
$
|
8,910
|
|
$
|
1,879
|
|
$
|
25,677
|
|
$
|
(3,857)
|
Basic net income
(loss) per share
|
|
$
|
0.25
|
|
$
|
0.05
|
|
$
|
0.72
|
|
$
|
(0.11)
|
Diluted net income
(loss) per share
|
|
$
|
0.23
|
|
$
|
0.05
|
|
$
|
0.68
|
|
$
|
(0.11)
|
Shares used in
computing basic net income (loss) per share
|
|
|
36,227
|
|
|
34,856
|
|
|
35,727
|
|
|
34,495
|
Shares used in
computing diluted net income (loss) per share.
|
|
|
38,565
|
|
|
35,709
|
|
|
37,555
|
|
|
34,495
|
|
|
|
|
|
|
|
|
(1)
|
Included in operating
expenses for the three months ended December 31, 2018 were non-cash
charges of $8.6 million, including $5.3 million of stock-based
compensation expense and $3.3 million of depreciation and
amortization expenses, compared with non-cash charges for the same
period in 2017 of $8.2 million, including $5.0 million of
stock-based compensation expense and $3.2 million of depreciation
and amortization expenses.
|
(2)
|
Included in operating
expenses for the year ended December 31, 2018 were non-cash charges
of $33.8 million, including $21.1 million of stock-based
compensation expense and $12.7 million of depreciation and
amortization expenses, compared with non-cash charges for the same
period in 2017 of $32.0 million, including $20.3 million of
stock-based compensation expense and $11.7 million of depreciation
and amortization expenses.
|
GENOMIC
HEALTH, INC.
|
Condensed
Consolidated Balance Sheets
|
(In
thousands)
|
|
|
|
As
of
|
|
As
of
|
|
|
December 31,
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
|
(Unaudited)
|
|
(1)
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
61,645
|
|
$
|
45,518
|
Short-term marketable
securities (2)
|
|
|
148,149
|
|
|
84,057
|
Accounts receivable,
net
|
|
|
51,531
|
|
|
31,161
|
Prepaid expenses and
other current assets
|
|
|
13,511
|
|
|
13,524
|
Total current
assets
|
|
|
274,836
|
|
|
174,260
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
39,532
|
|
|
46,440
|
Long-term marketable
securities
|
|
|
4,066
|
|
|
—
|
Other
assets
|
|
|
15,938
|
|
|
10,917
|
Total
assets
|
|
$
|
334,372
|
|
$
|
231,617
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
8,849
|
|
$
|
156
|
Accrued expenses and
other current liabilities
|
|
|
50,927
|
|
|
39,360
|
Other
liabilities
|
|
|
4,436
|
|
|
3,810
|
Stockholders'
equity
|
|
|
270,160
|
|
|
188,291
|
Total liabilities and
stockholders' equity
|
|
$
|
334,372
|
|
$
|
231,617
|
|
|
|
|
|
|
|
(1)
|
The condensed
consolidated balance sheet at December 31, 2017, 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, 2017.
|
(2)
|
Included in
short-term marketable securities as of December 31, 2018 and
December 31, 2017 is $3.1 million and $3.5 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
|
|
Year
Ended
|
|
|
December 31,
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Income (loss) from
operations reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income (loss)
from operations
|
|
$
|
9,426
|
|
$
|
2,150
|
|
$
|
23,896
|
|
$
|
(6,450)
|
Cost of product
revenues – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
3,519
|
|
|
—
|
Research and
development – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
3,039
|
|
|
—
|
Selling and marketing
– cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
1,064
|
|
|
—
|
General and
administrative – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
909
|
|
|
—
|
Research and
development – Biocartis license and option fee payments
|
|
|
2,874
|
|
|
—
|
|
|
4,043
|
|
|
3,249
|
Research and
development – discount on convertible promissory note
|
|
|
—
|
|
|
671
|
|
|
—
|
|
|
671
|
Research and
development – discount on equity investment for lack of
marketability during lock up period
|
|
|
—
|
|
|
322
|
|
|
—
|
|
|
322
|
Research and
development – milestone payment Biocartis
|
|
|
—
|
|
|
—
|
|
|
990
|
|
|
—
|
Research and
development – Cleveland Diagnostics cancellation of collaboration
agreement
|
|
|
—
|
|
|
—
|
|
|
1,329
|
|
|
—
|
Non-GAAP income
(loss) from operations
|
|
$
|
12,300
|
|
$
|
3,143
|
|
$
|
38,789
|
|
$
|
(2,208)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income
(loss)
|
|
$
|
8,910
|
|
$
|
1,879
|
|
$
|
25,677
|
|
$
|
(3,857)
|
Cost of product
revenues – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
3,519
|
|
|
—
|
Research and
development – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
3,039
|
|
|
—
|
Selling and marketing
– cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
1,064
|
|
|
—
|
General and
administrative – cessation of Oncotype SEQ
|
|
|
—
|
|
|
—
|
|
|
909
|
|
|
—
|
Research and
development – Biocartis license and option fee payments
|
|
|
2,874
|
|
|
—
|
|
|
4,043
|
|
|
3,249
|
Research and
development – discount on convertible promissory note
|
|
|
—
|
|
|
671
|
|
|
—
|
|
|
671
|
Research and
development – discount on equity investment for lack of
marketability during lock up period
|
|
|
—
|
|
|
322
|
|
|
—
|
|
|
322
|
Research and
development – milestone payment Biocartis
|
|
|
—
|
|
|
—
|
|
|
990
|
|
|
—
|
Research and
development – Cleveland Diagnostics cancellation of collaboration
agreement
|
|
|
—
|
|
|
—
|
|
|
1,329
|
|
|
—
|
Other income –
Biocartis - change in fair value
|
|
|
591
|
|
|
—
|
|
|
295
|
|
|
—
|
Other income – Epic
Sciences - revaluation of investment
|
|
|
—
|
|
|
—
|
|
|
(1,171)
|
|
|
|
Non-recurring gain on
sale of marketable securities
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,807)
|
Reduced income tax
expense from the sale of marketable securities
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
821
|
Non-GAAP net income
(loss)
|
|
$
|
12,375
|
|
$
|
2,872
|
|
$
|
39,694
|
|
$
|
(1,601)
|
GENOMIC HEALTH,
INC.
|
Non-GAAP Constant
Currency Reconciliations
|
(In
thousands)
|
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
December 31,
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Constant currency
reconciliations:
|
|
|
|
|
|
|
|
|
|
|
|
|
International
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
International revenue
(1)(2)
|
|
$
|
15,981
|
|
$
|
13,399
|
|
$
|
59,429
|
|
$
|
52,009
|
Currency
exchange adjustments (3)
|
|
|
231
|
|
|
—
|
|
|
(1,162)
|
|
|
—
|
Non-GAAP
International revenue
|
|
$
|
16,212
|
|
$
|
13,399
|
|
$
|
58,267
|
|
$
|
52,009
|
Period
over period constant currency increase
|
|
|
2,813
|
|
|
|
|
|
6,258
|
|
|
|
Period
over period constant currency increase percentage
|
|
|
21%
|
|
|
|
|
|
12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
(1)(2)
|
|
$
|
104,609
|
|
$
|
85,719
|
|
$
|
394,111
|
|
$
|
333,956
|
Currency
exchange adjustments (3)
|
|
|
231
|
|
|
—
|
|
|
(1,162)
|
|
|
—
|
Non-GAAP total
revenue
|
|
$
|
104,840
|
|
$
|
85,719
|
|
$
|
392,949
|
|
$
|
333,956
|
Period
over period constant currency increase
|
|
|
19,121
|
|
|
|
|
|
58,993
|
|
|
|
Period
over period constant currency increase percentage
|
|
|
22%
|
|
|
|
|
|
18%
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
For the three and
twelve months ended December 31, 2018, International revenue and
total revenue is based on GAAP under ASC 606 and for the three and
twelve months ended December 31, 2017, International revenue and
total revenue is based on the Pre-606 Adjusted revenue on the
following table.
|
(2)
|
For the three and
twelve months ended December 31, 2018 compared to the same periods
ended December 31, 2017, the increases in International revenue
were 19% and 14%, respectively. For the three and twelve
months ended December 31, 2018 compared to the same periods ended
December 31, 2017, the increases in Total revenue were 22% and 18%
respectively.
|
(3)
|
Constant currency is
a non-GAAP measure that is calculated by comparing the company's
quarterly average foreign exchange rates for the three and twelve
months ended December 31, 2018 and 2017. 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.
|
Non-GAAP
Supplemental Financial Information (1)
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2017
|
|
2017
|
U.S. Product
revenue, under ASC 605:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
$
|
66,210
|
|
$
|
259,727
|
Prostate test
revenue
|
|
|
|
4,990
|
|
|
17,930
|
All other test
revenue
|
|
|
|
2,286
|
|
|
9,707
|
Total U.S. product
revenue
|
|
|
|
73,486
|
|
|
287,364
|
Adjustment related
to new ASC 606 accounting standard:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
1,465
|
|
|
5,716
|
Prostate test
revenue
|
|
|
|
—
|
|
|
—
|
All other test
revenue
|
|
|
|
—
|
|
|
—
|
Total ASC 606
adjustment to U.S. product revenue
|
|
|
|
1,465
|
|
|
5,716
|
Pre-606 Adjusted
U.S. Product revenue, net of adjustments:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
64,745
|
|
|
254,011
|
Prostate test
revenue
|
|
|
|
4,990
|
|
|
17,930
|
All other test
revenue
|
|
|
|
2,286
|
|
|
9,707
|
Total Pre-606
Adjusted U.S. product revenue
|
|
|
$
|
72,021
|
|
$
|
281,648
|
|
|
|
|
|
|
|
|
International
product revenue, under ASC 605:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
$
|
13,517
|
|
$
|
52,436
|
Prostate test
revenue
|
|
|
|
23
|
|
|
129
|
All other test
revenue
|
|
|
|
138
|
|
|
522
|
Total International
product revenue
|
|
|
|
13,678
|
|
|
53,087
|
Adjustment related
to new ASC 606 accounting standard:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
279
|
|
|
1,078
|
Prostate test
revenue
|
|
|
|
—
|
|
|
—
|
All other test
revenue
|
|
|
|
—
|
|
|
—
|
Total ASC 606
adjustment to International product revenue
|
|
|
|
279
|
|
|
1,078
|
Pre-606 Adjusted
International product revenue, net of adjustments:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
13,238
|
|
|
51,358
|
Prostate test
revenue
|
|
|
|
23
|
|
|
129
|
All other test
revenue
|
|
|
|
138
|
|
|
522
|
Total Pre-606
Adjusted International product revenue
|
|
|
$
|
13,399
|
|
$
|
52,009
|
|
|
|
|
|
|
|
|
Total Product
Revenue, under ASC 605:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
$
|
79,727
|
|
$
|
312,163
|
Prostate test
revenue
|
|
|
|
5,013
|
|
|
18,059
|
All other test
revenue
|
|
|
|
2,424
|
|
|
10,229
|
Total product
revenue
|
|
|
|
87,164
|
|
|
340,451
|
Adjustment related
to new ASC 606 accounting standard:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
1,744
|
|
|
6,794
|
Prostate test
revenue
|
|
|
|
—
|
|
|
—
|
All other test
revenue
|
|
|
|
—
|
|
|
—
|
Total ASC 606
adjustment to total product revenue
|
|
|
|
1,744
|
|
|
6,794
|
Pre-606 Adjusted
Total product revenue, net of adjustments:
|
|
|
|
|
|
|
|
Invasive breast test
revenue
|
|
|
|
77,983
|
|
|
305,369
|
Prostate test
revenue
|
|
|
|
5,013
|
|
|
18,059
|
All other test
revenue
|
|
|
|
2,424
|
|
|
10,229
|
Total Pre-606
Adjusted total product revenue
|
|
|
$
|
85,420
|
|
$
|
333,657
|
GENOMIC HEALTH,
INC.
|
Non-GAAP
Supplemental Financial Information (1)
|
(In
thousands)
|
(Unaudited)
|
|
(1)
|
Effective January 1,
2018, the company adopted new accounting guidance ASC Topic 606
("ASC 606"), related to revenue from contracts with customers,
using a modified retrospective method. Since the 2017 annual and
quarterly financial statements will not be restated to reflect ASC
606, the company is providing this supplemental schedule to present
2017 revenue reflecting an estimate as if ASC 606 had been applied
effective January 1, 2017. This pre-606 adjusted revenue
information is intended to provide investors with a basis for
considering the potential directional impact the adoption of ASC
606 might have on the company's financial information that will be
reported in 2018. The pre-606 adjusted revenue information is
provided only for illustrative purposes and does not constitute a
restatement of the company's historical financial statements
previously filed with the SEC, which should be considered by
investors in their entirety as filed.
|
GHDX-F
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SOURCE Genomic Health, Inc.