FOSTER CITY, Calif.,
March 6, 2017 /PRNewswire/
-- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today
reported financial results for the fourth quarter and year ended
December 31, 2016.
- Revenues: In the fourth quarter of 2016, SciClone
reported revenues of $44.1 million,
compared to $42.9 million for the
same period in 2015. Revenues for the full year 2016 were
$160.1 million, compared to
$157.3 million for the full year of
2015.
- GAAP Diluted EPS: In the fourth quarter of 2016,
SciClone reported GAAP diluted net income per share of $0.12, compared to GAAP diluted net income per
share of $0.24 for the same period in
2015. GAAP diluted net income per share for the full year 2016 was
$0.58, compared to $0.56 for the full year of 2015.
- Non-GAAP Diluted EPS: In the fourth quarter of 2016,
SciClone reported non-GAAP diluted net income per share of
$0.20, compared to $0.30 for the same period in 2015. Non-GAAP
diluted net income per share for the full year of 2016 was
$0.83, compared to $1.00 for the full year of 2015.
Revenues in the fourth quarter of 2016 were $44.1 million, a $1.2
million or 3% increase, compared to $42.9 million for the same period in 2015. For
the year ended December 31, 2016,
revenues were $160.1 million,
compared to revenues of $157.3
million last year. ZADAXIN® revenues were
$42.2 million in the fourth quarter
of 2016, a $2.0 million or 5%
increase, compared to $40.2 million
for the same period in 2015. The 5% increase in ZADAXIN revenues
for the fourth quarter of 2016, compared to the same period last
year, includes an 8% increase in ZADAXIN volume sales, partially
offset primarily by the effects of foreign exchange, compared to
the same period last year. ZADAXIN revenues were $150.1 million for the year ended December 31, 2016, a $4.0
million or 3% increase, compared to $146.1 million for the full year of 2015.
Promotion services revenues were $0.8
million for the fourth quarter of 2016, a $0.1 million or 13% decrease compared to
$0.9 million in the same period in
2015. Promotion services revenues were $4.2
million for the year ended December
31, 2016, compared to $2.9
million for the year ended December
31, 2015, a $1.2 million or
42% increase year over year, reflecting overall higher demand for
the Company's promotion services oncology portfolio.
On a GAAP basis, SciClone reported net income in the fourth
quarter of 2016 of $6.4 million, or
$0.13 and $0.12 per share on a basic and diluted basis,
respectively, compared to net income of $12.5 million, or $0.25 and $0.24 per
share on a basic and diluted basis, respectively, for the same
period in 2015. SciClone's net income for the year ended
December 31, 2016 was $30.7 million, compared with net income of
$29.5 million for the same period in
the prior year, or $0.61 and
$0.58 per share on a basic and
diluted basis, respectively, for the year ended December 31, 2016, compared with $0.59 and $0.56 per
share on a basic and diluted basis, respectively, for the full year
of 2015.
SciClone's non-GAAP net income in the fourth quarter of 2016 was
$10.7 million, or $0.21 and $0.20 per
share on a basic and diluted basis, respectively, compared with
non-GAAP net income of $15.5 million,
or $0.31 and $0.30 per share on a basic and diluted basis,
respectively, for the same period last year. SciClone's non-GAAP
net income for the year ended December 31,
2016 was $43.8 million,
compared with non-GAAP net income of $52.2
million for the full year of 2015, or $0.87 and $0.83 per
share on a basic and diluted basis, respectively, for the year
ended December 31, 2016, compared
with non-GAAP net income of $1.05 and
$1.00 per share on a basic and
diluted basis, respectively, for the full year of 2015.
Friedhelm Blobel, PhD, SciClone's
Chief Executive Officer, commented: "We are pleased with our
performance in the fourth quarter and year to date 2016, which is
in line with our expectations, and reflects the value and continued
growth potential of our core business, led by ZADAXIN. ZADAXIN's
volume growth continues to out-perform the growth rate of the
China pharmaceuticals market,
underscoring its strength as the leading thymalfasin brand, with a
17% volume share and more than a 40% value share. We are confident
that ZADAXIN has significant growth potential as a differentiated,
high quality, Western-manufactured brand, and that the marketplace
demand will remain strong in 2017.
"In 2016, we achieved strong growth in our oncology portfolio,
as reflected in a 19% overall increase year over year in our Pfizer
and Baxter oncology business. The
market introduction of DC Bead® is progressing as well as our
pipeline of products in various stages of development. We
successfully won new tenders in 2016 at favorable pricing. A key
2017 goal is to increase the pace of market uptake and drive sales.
We expect additional progress in advancing our development
portfolio in 2017, including the important upcoming milestone of
the approval of the Angiomax® bivalirudin new drug application,
anticipated at the end of the year or beginning of 2018.
"The China pharmaceuticals
market continues to evolve, presenting both challenges and
opportunities. The expected growth rate of 6-7% continues to
outpace Western markets, reinforcing our confidence in continued
opportunities for SciClone's success. Our core strategies are to
continually grow our commercial business, advance and expand our
development portfolio through creative partnering, maintain high
levels of fiscal responsibility and compliance and continue to
build our reputation and standing as a key player in the
China pharma market."
For the fourth quarter of 2016, sales and marketing (S&M)
expenses were $14.6 million, compared
with $14.9 million for the same
period of 2015. The decrease in S&M for the fourth quarter of
2016, compared to the same period in 2015, is primarily related to
decreases in sales and marketing events and lower DC Bead-related
launch costs. For the year ended December
31, 2016, S&M expenses were $54.7
million, compared with $54.0
million, for the full year of 2015.
For the fourth quarter of 2016, research and development
(R&D) expenses were $5.6 million,
compared with $3.6 million of R&D
expenses for the same period of 2015. For the fourth quarter of
2016 and 2015, we recorded $2.3
million and $2.0 million,
respectively, related to upfront and milestone payments for
in-license arrangements with certain licensees and $3.3 million and $1.6
million, respectively, related to R&D expenses for
clinical and preclinical R&D activities with certain licensees.
For the year ended December 31, 2016,
R&D expenses were $15.1 million,
compared with $12.3 million, for the
full year of 2015.
For the fourth quarter of 2016, general and administrative
(G&A) expenses were $10.7
million, compared with $6.5
million for the same period in 2015. For the year ended
December 31, 2016, G&A expenses
were $34.2 million, compared with
$27.9 million for the full year of
2015. G&A was higher for both the fourth quarter and year 2016,
compared to the same periods of 2015, related to legal costs in
connection with the Company's ongoing strategic review, higher
transaction losses on foreign exchange related to sales of ZADAXIN
to our exclusive China importer
and tier 1 distributor being denominated in RMB since July 1, 2016, and stock-based compensation
expenses.
For the fourth quarter of 2016, SciClone's income tax
expense was $0.8 million, compared with $0.2 million for the same period in 2015. Income
tax expense was higher in the fourth quarter of 2016 related to
sales and related marketing activities of the Company's
China business for the fourth
quarter of 2016. For the year ended December
31, 2016, income tax expense was $3.4
million, compared with $0.8
million, for the full year of 2015, and included a
$1.3 million uncertain tax provision
for our China operations.
As of December 31, 2016, cash and
cash equivalents totaled $134.4
million, compared to $101.4
million as of December 31,
2015, excluding the $12.8
million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which
was released and paid in February
2016.
SciClone has presented non-GAAP information above as the Company
believes this non-GAAP information is useful for investors, taken
in conjunction with SciClone's GAAP financial statements, because
management uses such information internally for its operating,
budgeting and financial planning purposes. Non-GAAP information is
not prepared under a comprehensive set of accounting rules and
should only be used to supplement an understanding of SciClone's
operating results as reported under GAAP. The non-GAAP calculations
and reconciliation are provided in the accompanying table titled
"Reconciliation of GAAP to Non-GAAP Net Income" except that for the
non-GAAP EPS referenced in "Outlook for 2017" below, the
Company is unable to provide a quantitative reconciliation of its
forward-looking estimate of non-GAAP EPS to a forward-looking
estimate of GAAP EPS because certain information needed to make a
reasonable forward-looking estimate of GAAP EPS for the full fiscal
year 2017 is difficult to predict and estimate and is often
dependent on future events which may be uncertain or outside of the
Company's control, for example, milestone payments.
Outlook for 2017
SciClone projects its 2017 revenue to be in the range between
$170 and $175 million, driven by
ZADAXIN revenues; and its non-GAAP diluted earnings per share to be
in the range between $0.60 and
$0.64.
The Company's outlook for 2017 continues to be influenced by
several factors, including the overall growth rate of the
China pharmaceuticals market,
anticipated pricing pressure at the provincial level, the effects
of foreign exchange and higher R&D expenses as it continues to
advance its pipeline products toward commercialization. The Company
further expects that pricing pressures on revenue in 2017 will be
offset, at least in significant part, through sharing of the burden
with its China distributors and
potentially through volume increases.
Conference Call Today
SciClone is hosting a conference call today at 8:30 am ET (5:30 am
PT) to provide a financial update. The call will be
hosted by Friedhelm Blobel, PhD,
President and Chief Executive Officer, and Wilson W. Cheung, Senior Vice President and
Chief Financial Officer.
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LIVE
CALL:
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877.674.6420
(US/Canada)
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920.663.6281
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Passcode:
57040719
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The conference call will contain forward-looking statements.
Interested parties who wish to listen to the webcast should visit
the Investor Relations section of SciClone's website at
www.sciclone.com. The information provided on the teleconference is
accurate only at the time of the conference call, and SciClone will
take no responsibility for providing updated information except as
required by law.
About SciClone
SciClone Pharmaceuticals is a revenue-generating, specialty
pharmaceutical company with a substantial commercial business in
China and a product portfolio
spanning major therapeutic markets including oncology, infectious
diseases and cardiovascular disorders. SciClone's proprietary
lead product, ZADAXIN® (thymalfasin), is approved
in over 30 countries and may be used for the treatment of hepatitis
B (HBV), hepatitis C (HCV), and certain cancers, and as an immune
system enhancer, according to the local regulatory approvals. The
Company has successfully in-licensed and commercialized products
with the potential to become future market leaders and to drive the
Company's long-term growth, including DC Bead®, a novel
treatment for liver cancer now approved in China, and several other products in late
stage development in China.
Through its promotion business with pharmaceutical partners,
SciClone also markets multiple branded products in China which are therapeutically
differentiated. SciClone is a publicly-held corporation based in
Foster City, California, and
trades on the NASDAQ Global Select Market under the symbol SCLN.
For additional information, please visit www.sciclone.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
expected future events and SciClone's financial results and
expectations, including, without limitation, statements regarding
SciClone's business strategy and growth, product and development
portfolios, market opportunities and forecasted financial
results. Readers are urged to consider statements that
include the words "may," "will," "would," "could," "should,"
"might," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," "approximately" or the negative of
those words or other comparable words to be uncertain and
forward-looking. These statements are subject to risks and
uncertainties that are difficult to predict and actual outcomes may
differ materially. These include risks and uncertainties relating
to: the course, cost and outcome of regulatory matters, including
future pricing decisions by authorities in China; the dependence of SciClone's sales of
ZADAXIN in China; SciClone's
ability to execute on its goals in China and on its objectives for earnings and
revenue in fiscal 2017; SciClone's ability to implement and
maintain controls over its financial reporting; the
dependence of its current and future revenue and prospects on
third-party license, promotion or distribution agreements,
including the need to renew such agreements, enter into similar
agreements, or end arrangements that SciClone does not believe are
beneficial; operating an international business, including currency
exchange fluctuations; uncertainty in the prospects for unapproved
products, including uncertainties as to pricing and competition and
risks relating to the clinical trial process and related regulatory
approval process and the process of initiating trials at, and
enrolling patients at, clinical sites. Please also refer to other
risks and uncertainties described in SciClone's filings with the
SEC. All forward-looking statements are based on information
currently available to SciClone and SciClone assumes no obligation
to update any such forward-looking statements.
SciClone, SciClone Pharmaceuticals, the SciClone
Pharmaceuticals design, the SciClone logo and ZADAXIN are
registered trademarks of SciClone Pharmaceuticals, Inc. in
the United States and numerous
other countries.
SCICLONE
PHARMACEUTICALS, INC.
UNAUDITED
CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per
share amounts)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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2016
|
|
2015
|
|
2016
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2015
|
Revenues:
|
|
|
|
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|
|
|
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Product sales,
net
|
|
$
|
43,291
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|
$
|
41,973
|
|
$
|
155,937
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|
$
|
154,329
|
Promotion
services
|
|
|
771
|
|
|
890
|
|
|
4,159
|
|
|
2,928
|
Total net
revenues
|
|
|
44,062
|
|
|
42,863
|
|
|
160,096
|
|
|
157,257
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
|
5,788
|
|
|
5,217
|
|
|
22,898
|
|
|
22,348
|
Sales and
marketing
|
|
|
14,600
|
|
|
14,863
|
|
|
54,704
|
|
|
53,961
|
Research and
development
|
|
|
5,558
|
|
|
3,606
|
|
|
15,078
|
|
|
12,314
|
General and
administrative
|
|
|
10,709
|
|
|
6,487
|
|
|
34,181
|
|
|
27,897
|
SEC settlement
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,826
|
Total operating
expenses
|
|
|
36,655
|
|
|
30,173
|
|
|
126,861
|
|
|
127,346
|
Income from
operations
|
|
|
7,407
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|
|
12,690
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|
|
33,235
|
|
|
29,911
|
Non-operating
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
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Interest and investment
income
|
|
|
270
|
|
|
255
|
|
|
1,062
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|
|
869
|
Other expense,
net
|
|
|
(494)
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|
|
(205)
|
|
|
(164)
|
|
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(510)
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Income before
provision for income tax
|
|
|
7,183
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|
|
12,740
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|
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34,133
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|
|
30,270
|
Provision for income
tax
|
|
|
772
|
|
|
196
|
|
|
3,404
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|
|
807
|
Net
income
|
|
$
|
6,411
|
|
$
|
12,544
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|
$
|
30,729
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$
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29,463
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|
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Basic net income
per share
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$
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0.13
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$
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0.25
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$
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0.61
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$
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0.59
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Diluted net income
per share
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|
$
|
0.12
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$
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0.24
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$
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0.58
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$
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0.56
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|
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|
|
|
|
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|
|
|
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|
|
Basic shares
outstanding
|
|
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51,063
|
|
|
49,433
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|
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50,235
|
|
|
49,797
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Diluted shares
outstanding
|
|
|
52,751
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|
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51,657
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|
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52,566
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|
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52,173
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SCICLONE
PHARMACEUTICALS, INC.
RECONCILIATION OF
GAAP TO NON-GAAP NET INCOME (in thousands, except per share
amounts)
(unaudited)
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|
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|
|
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Three Months
Ended
|
|
Year
Ended
|
|
|
December
31,
|
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December
31,
|
|
|
|
|
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|
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|
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|
|
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2016
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2015
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2016
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2015
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GAAP net
income
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$
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6,411
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|
$
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12,544
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|
$
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30,729
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$
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29,463
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Non-GAAP
adjustments:
|
|
|
|
|
|
|
|
|
|
|
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|
Employee stock-based
compensation
|
|
|
1,857
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|
|
1,004
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|
|
6,433
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|
|
4,441
|
In-license upfront and
milestone costs
|
|
|
2,263
|
|
|
2,000
|
|
|
4,518
|
|
|
7,500
|
SEC settlement
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,826
|
Strategic review
expense
|
|
|
202
|
|
|
—
|
|
|
2,156
|
|
|
—
|
Non-GAAP net
income
|
|
$
|
10,733
|
|
$
|
15,548
|
|
$
|
43,836
|
|
$
|
52,230
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net
income per share
|
|
$
|
0.21
|
|
$
|
0.31
|
|
$
|
0.87
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|
$
|
1.05
|
Non-GAAP diluted net
income per share
|
|
$
|
0.20
|
|
$
|
0.30
|
|
$
|
0.83
|
|
$
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
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|
|
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|
|
|
|
|
Non-GAAP basic net
income per share
|
|
|
51,063
|
|
|
49,433
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|
|
50,235
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|
|
49,797
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Non-GAAP diluted net
income per share
|
|
|
52,751
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|
|
51,657
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|
|
52,566
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|
|
52,173
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SciClone management uses these non-GAAP financial measures to
monitor and evaluate the Company's operating results and trends on
an on-going basis and internally for operations, budgeting and
financial planning purposes. SciClone believes the non-GAAP
information is useful for investors by offering them the ability to
better understand how management evaluates the business. These
non-GAAP measures have limitations, however, because they do not
include all items of income and expenses that affect SciClone.
These non-GAAP financial measures that management uses are not
prepared in accordance with, and should not be considered in
isolation of, or as an alternative to, measurements required by
GAAP.
SciClone's non-GAAP financial measures exclude the following
items from GAAP net income and net income per share:
- Employee stock-based compensation. The effects of
non-cash employee stock-based compensation.
- In-license upfront and milestone costs. SciClone
recorded $2.3 million and
$2.0 million to R&D expense
related to upfront and milestone payments incurred under licensing
agreements in the fourth quarter of 2016 and 2015, respectively.
SciClone recorded $4.5 million and
$7.5 million to R&D expense
related to upfront and milestone payments incurred under licensing
agreements in the years ended December 31,
2016 and 2015, respectively.
- SEC settlement expense. The Company recorded additional
expense in 2015 related to its settlement with the SEC.
- Strategic review expense. The effects of costs incurred
related to the Company's strategic review for the purpose of
maximizing shareholder value.
SCICLONE
PHARMACEUTICALS, INC.
UNAUDITED SELECTED
BALANCE SHEET DATA (in thousands)
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2016
|
|
2015
|
Cash and cash
equivalents
|
|
$
|
134,395
|
|
$
|
101,403
|
Restricted
cash
|
|
|
—
|
|
|
12,826
|
Accounts receivable,
net
|
|
|
41,510
|
|
|
39,363
|
Inventories
|
|
|
16,587
|
|
|
10,976
|
Goodwill
|
|
|
30,838
|
|
|
32,979
|
Total
assets
|
|
|
241,898
|
|
|
216,619
|
Total current
liabilities
|
|
|
26,441
|
|
|
36,820
|
Total shareholders'
equity
|
|
|
215,365
|
|
|
179,712
|
Corporate Contacts
|
|
Wilson W.
Cheung
|
Jane Green
|
Chief Financial
Officer
|
Investors/Media
|
650.358.3434
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650.358.1447
|
wcheung@sciclone.com
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jgreen@sciclone.com
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sciclone-reports-2016-financial-results-and-2017-outlook-300418145.html
SOURCE SciClone Pharmaceuticals, Inc.