UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 20-F
(Mark One)
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2015
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report
For the transition period from to
Commission file number: 001-32371
SINOVAC BIOTECH LTD.
(Exact name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
Antigua, West Indies
(Jurisdiction of incorporation or organization)
No. 39 Shangdi Xi Road,
Haidian District, Beijing 100085
People’s Republic of China
(Address of principal executive offices)
Nan Wang
Chief Financial Officer
No. 39 Shangdi Xi Road,
Haidian District, Beijing 100085
People’s Republic of China
Tel: +86-10-8289-0088
Fax: +86-10-6296-6910
E-mail: ir@sinovac.com
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class
Common Shares, par value $0.001 per share
Preferred Share Purchase Rights
Name of each exchange on which registered
The NASDAQ Stock Market LLC
(The NASDAQ Global Select Market)
Securities registered or to be registered pursuant to Section 12(g) of the Act:
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
(Title of Class)
None
(Title of Class)
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
56,906,561 common shares as of December 31, 2015
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.
Yes No
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to
be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or such shorter period that the registrant was required to
submit and post such files).
Yes No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and
large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Accelerated filer
Large accelerated filer
Non-accelerated filer
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP
Other
International Financial Reporting Standards as issued
by the International Accounting Standards Board
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes No
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act
of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Yes No
CONTENTS
INTRODUCTION
PART I
ITEM 1.
ITEM 2.
ITEM 3.
ITEM 4.
ITEM 4A.
ITEM 5.
ITEM 6.
ITEM 7.
ITEM 8.
ITEM 9.
ITEM 10.
ITEM 11.
ITEM 12.
Identity of Directors, Senior Management and Advisers
Offer Statistics and Expected Timetable
Key Information
Information on the Company
Unresolved Staff Comments
Operating and Financial Review and Prospects
Directors, Senior Management and Employees
Major Shareholders and Related Party Transactions
Financial Information
The Offer and Listing
Additional Information
Quantitative and Qualitative Disclosures about Market Risk
Description of Securities other than Equity Securities
PART II
ITEM 13.
ITEM 14.
ITEM 15.
ITEM 16A.
ITEM 16B.
ITEM 16C.
ITEM 16D.
ITEM 16E.
ITEM 16F.
ITEM 16G.
ITEM 16H.
Defaults, Dividend Arrearages and Delinquencies
Material Modifications to the Rights of Security Holders and Use of Proceeds
Controls and Procedures
Audit Committee Financial Expert
Code of Ethics
Principal Accountant Fees and Services
Exemptions from the Listing Standards for Audit Committees
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Change in Registrant’s Certifying Accountant
Corporate Governance
Mine Safety Disclosure
PART III
ITEM 17.
ITEM 18.
ITEM 19.
Financial Statements
Financial Statements
Exhibits
Page
1
2
2
2
2
31
47
47
64
73
74
75
76
87
87
88
88
88
88
89
90
90
90
90
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90
91
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91
91
91
INTRODUCTION
In this annual report on Form 20-F, unless otherwise indicated or unless the context otherwise requires,
“Sinovac,” “Company,” “we,” “us,” “our company,” and “our” refer to Sinovac Biotech Ltd., its predecessor entities and its consolidated subsidiaries
“China,” “Chinese” or the “PRC” refers to the People’s Republic of China, excluding, for the purposes of this annual report on Form 20-F only, Taiwan and
the special administrative regions of Hong Kong and Macau;
“RMB” or “renminbi” refers to the legal currency of China; and “$” or “U.S. dollars” refers to the legal currency of the United States;
“shares” or “common shares” refers to our common shares, par value $0.001 per share; and
“U.S. GAAP” refers to generally accepted accounting principles in the United States.
Discrepancies in any table between the amounts identified as total amounts and the sum of the amounts listed therein are due to rounding.
This annual report contains translations of certain renminbi amounts into U.S. dollars at specified rates solely for the convenience of the readers. All translations
from renminbi to U.S. dollars were made at the noon buying rate in The City of New York for cable transfers in renminbi per U.S. dollar as certified for customs
purposes by the Federal Reserve Bank of New York, or the noon buying rate. Unless otherwise stated, the translation of renminbi into U.S. dollars has been
made at the noon buying rate in effect on December 31, 2015, which was RMB6.4778 to $1.00. We make no representation that the renminbi or U.S. dollar
amounts referred to in this annual report could have been or could be converted into U.S. dollars or renminbi, as the case may be, at any particular rate or at all.
On April 15, 2016, the noon buying rate was RMB6.4730 to $1.00.
1
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. Selected Financial Data
The following selected consolidated statements of comprehensive income (loss) data for the fiscal years ended December 31, 2015, 2014 and 2013, and
consolidated balance sheet data as of December 31, 2015 and 2014 have been derived from our audited consolidated financial statements that are included in
this annual report beginning on page F-1. The following selected consolidated statements of comprehensive income (loss) data for the fiscal years ended
December 31, 2012 and 2011 and consolidated balance sheet data as of December 31, 2013, 2012 and 2011 have been derived from our audited consolidated
financial statements that are not included in this annual report. Amounts previously reported have been reclassified, as necessary, to conform to discontinued
operations presentation in accordance with ASC 205, Presentation of Financial Statements to allow for meaningful comparison of continuing operations.
Our historical results do not necessarily indicate results expected for any future periods. The selected consolidated financial data should be read in conjunction
with our audited consolidated financial statements and related notes and Item 5 “Operating and Financial Review and Prospects” below. Our audited
consolidated financial statements are prepared and presented in accordance with U.S. GAAP.
Consolidated statements of
Comprehensive income (loss) data
Sales
Cost of sales(1)
Gross profit
Operating expenses:
Selling, general and administrative expenses(1)
Provision (recovery) for doubtful accounts
Research and development expenses(1)
Loss on disposal and impairment of property, plant and equipment
Government grants recognized in income
Total operating expenses
Operating income (loss)
Interest and financing expenses
Interest income
Other income (expenses)
Income (loss) before income taxes and non-controlling interests
Income tax benefit (expenses)
Income (loss) from continuing operations
Loss from discontinued operations, net of tax nil
Net income (loss)
Less: (income) loss attributable to non-controlling interests
Net income (loss) attributable to shareholders of Sinovac
Comprehensive income (loss)
Less: comprehensive (income) loss attributable to non-controlling
interests
Comprehensive income (loss) attributable to shareholders of Sinovac
Weighted average number of common shares outstanding
- basic
- diluted
Earnings (loss) per share
Year ended December 31,
2015
2014
2013
2012
2011
(in thousands except share and per share data)
$
67,414 $
18,425
48,989
62,932 $
15,476
47,456
37,436
(49)
9,490
26
(1,637)
45,266
3,723
(1,920)
1,155
73
3,031
(2,516)
515
(728)
(213)
(861)
(1,074)
(4,688)
34,166
329
10,934
74
(104)
45,399
2,057
(3,407)
2,684
1,312
2,646
(1,458)
1,188
(1,524)
(336)
(515)
(851)
(2,763)
71,774 $
20,505
51,269
33,611
(504)
8,128
88
-
41,323
9,946
(3,031)
2,167
329
9,411
2,225
11,636
(1,266)
10,370
(2,928)
7,442
13,056
49,167 $
17,208
31,959
32,222
(874)
16,775
663
(349)
48,437
(16,478)
(774)
2,365
(156)
(15,043)
884
(14,159)
(4,590)
(18,749)
3,896
(14,853)
(16,725)
56,842
20,973
35,869
22,998
(167)
7,760
452
(764)
30,279
5,590
(298)
1,395
130
6,817
(5,066)
1,751
(2,150)
(399)
(445)
(844)
3,240
$
(298)
(4,986) $
(207)
(2,970) $
(3,244)
9,812 $
3,665
(13,060) $
(974)
2,266
56,313,927
56,313,927
55,681,076
56,114,202
55,301,276
55,802,338
54,926,440
54,926,440
54,608,919
55,077,996
Basic net income (loss) per share:
Continuing operations
Discontinued operations
Basic net income (loss) per share
Diluted net income (loss) per share:
Continuing operations
Discontinued operations
Diluted net income (loss) per share
(0.01)
(0.01)
(0.02)
(0.01)
(0.01)
(0.02)
0.01
(0.03)
(0.02)
0.01
(0.03)
(0.02)
0.15
(0.02)
0.13
0.15
(0.02)
0.13
(0.19)
(0.08)
(0.27)
(0.19)
(0.08)
(0.27)
0.02
(0.04)
(0.02)
0.02
(0.04)
(0.02)
Weighted average number of shares of common stock outstanding
– Basic
– Diluted
56,313,927
56,313,927
55,681,076
56,114,202
55,301,276
55,802,338
54,926,440
54,926,440
54,608,919
55,077,996
Supplemental information(2)
Non-GAAP EBITDA
Non-GAAP net income (loss) from continuing operations
Non-GAAP Diluted EPS from continuing operations
11,185
2,353
0.03
10,440
2,094
0.03
16,635
11,267
0.15
(12,155)
(14,055)
(0.18)
10,305
2,000
0.03
(1) Includes stock-based compensation of $1.0 million, $0.3 million, $0.3 million, $0.3 million and $0.2 million in 2015, 2014, 2013, 2012 and 2011,
respectively.
(2) See “Non-GAAP Measures” below.
2
Non-GAAP Measures
We use non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations, in evaluating our
operating results and for financial and operational decision-making purposes.
We believe that non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations help identify
underlying trends in our business that could otherwise be distorted by the effect of certain income or expenses that we include in income from operations from
continuing operations, net income from continuing operations and diluted EPS from continuing operations. We believe that non-GAAP EBITDA, non-GAAP
net income from continuing operations and non-GAAP diluted EPS from continuing operations provide useful information about our core operating results,
enhance the overall understanding of our past performance and future prospects and allow for greater visibility with respect to key metrics used by management
in our financial and operational decision-making.
Non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations should not be considered in
isolation or construed as an alternative to income from operations from continuing operations, net income from continuing operations, diluted EPS from
continuing operations, or any other measure of performance or as an indicator of our operating performance. These non-GAAP financial measures presented
here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently,
limiting their usefulness as comparative measures to our data.
3
Non-GAAP EBITDA represents income (loss) from continuing operations, excludes interest and financing expenses, interest income, net other income
(expenses) and income tax benefit (expenses), and certain non-cash expenses, consisting of stock-based compensation expenses, amortization and depreciation
that we do not believe are reflective of our core operating performance during the periods presented.
Non-GAAP net income from continuing operations represents net income from continuing operations before stock-based compensation expenses, and
foreign exchange gain or loss.
Non-GAAP diluted EPS from continuing operations represents non-GAAP net income attributable to ordinary shareholders from continuing operations
divided by the weighted average number of shares outstanding during the periods on a diluted basis, including accounting for the effect of the assumed
conversion of options.
The table below sets forth a reconciliation of our income (loss) from continuing operations to non-GAAP EBITDA for the periods indicated:
Income (loss) from continuing operations
Adjustments:
Stock-based compensation
Depreciation and amortization
Interest and financing expenses, net of interest income
Net other (income) expense
Income tax (benefit) expense
Non-GAAP EBITDA
2015
Year ended December 31,
2013
2014
2012
2011
515
$
1,188
$
11,636 $
(14,159) $
1,751
952
6,510
765
(73)
2,516
11,185
$
287
8,096
723
(1,312)
1,458
10,440
$
281
6,408
864
(329)
(2,225)
16,635 $
347
3,976
(1,591)
156
(884)
(12,155) $
206
4,509
(1,097)
(130)
5,066
10,305
$
$
The following table sets forth a reconciliation of our net income from continuing operations to non-GAAP net income from continuing operations for the
periods indicated:
Income (loss) from continuing operations
Add: Foreign exchange loss (gain)
Add: Stock-based compensation
Non-GAAP net income (loss) from continuing operations
$
$
515
886
952
2,353
$
$
2015
2014
Year ended December 31,
2013
(in thousands)
$
1,188
619
287
2,094
$
11,636 $
(650)
281
11,267 $
2012
2011
(14,159) $
(243)
347
(14,055) $
1,751
43
206
2,000
The following table sets forth a reconciliation of our diluted EPS from continuing operations to non-GAAP diluted EPS from continuing operations for the
periods indicated:
4
2015
2014
Year ended December 31,
2013
(in thousands)
2012
2011
Net income (loss) from continuing operations attributable to
shareholders of Sinovac
$
Add: Non-GAAP adjustments to net income from continuing operations(1) $
Non-GAAP net income (loss) attributable to shareholders of Sinovac
(346) $
$
1,838
673
906
from continuing operations for computing non-GAAP diluted
earnings (loss) per share
Weighted average number of shares on a diluted basis
Diluted earnings (loss) per share from continuing operations (2)
Add: Non-GAAP adjustments to net income per share from continuing
operations (3)
Non-GAAP Diluted earnings (loss) per share from continuing
operations (4)
$
$
$
$
1,492
$
1,579
56,313,927
(0.01) $
55,681,076
0.01
0.04
0.03
$
$
0.02
0.03
$
$
$
$
$
$
8,708 $
(369) $
(10,263) $
$
104
1,306
249
8,339 $
(10,159) $
1,555
55,802,338 54,926,440
0.15 $
(0.19) $
54,608,919
0.02
0.00 $
0.01
$
0.15 $
(0.18) $
0.01
0.03
(1) See the table above about the reconciliation of net income from continuing operations to non-GAAP net income from continuing operations for more
information on these non-GAAP adjustments.
(2) Diluted EPS from continuing operations is derived from net income attributable to ordinary shareholders from continuing operations for computing diluted
EPS divided by weighted average number of shares on a diluted basis.
(3) Non-GAAP adjustments to net income per share from continuing operations is derived from non-GAAP adjustments to net income from continuing
operations divided by weighted average number of shares on a diluted basis.
(4) Non-GAAP diluted EPS from continuing operations is derived from non-GAAP net income attributable to ordinary shareholders from continuing
operations for computing non-GAAP diluted EPS from continuing operations divided by weighted average number of shares on a diluted basis.
Balance sheet data
Cash and cash equivalents(1)
Total assets
Short-term bank loans and current portion of long-term debt
Total current liabilities
Long term debt (include due to related party)
Net assets
Non-controlling interests
Common stock
Total shareholders’ equity
2015
2014
$
$
63,834
202,984
21,775
58,001
756
138,741
15,461
57
123,280
$
$
91,293
238,530
47,375
79,834
1,803
141,726
15,162
56
126,564
$
2012
2011
91,219
208,763
3,210
30,155
31,300
129,435
11,711
55
117,724
$
$
103,780
215,908
4,713
39,531
17,321
145,297
15,377
55
129,920
106,517 $
240,693
16,217
49,157
32,146
143,639
14,955
56
128,684 $
As of December 31,
2013
(in thousands)
$
(1) In December 2015, we committed to a plan to sell 100% stake in Tangshan Yian Biological Engineering Co., Ltd., or Tangshan Yian. The assets and
liabilities of Tangshan Yian are presented as held for sale as of December 31, 2015 and all comparative periods.
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
5
D. Risk Factors
Risks Related to Our Company
Our business growth relies on our ability to react to infectious disease threats and to continually introduce new vaccine products into the commercial
market. Our failure to effectively develop and commercialize new products could materially and adversely affect our business, financial condition, results of
operations and prospects.
The biopharmaceutical market in general and the vaccine product market in particular are developing rapidly as a result of ongoing infectious disease threats
and new trends in the related research and technology developments. Consequently, our success depends on our ability to react to disease and technology
development trends and to identify, develop and commercialize in a timely and cost-effective manner effective vaccine products that meet evolving market
needs.
Whether we are successful in developing and commercializing new products is determined by our ability to:
accurately assess disease and technology trends and market needs;
maintain strong research and development capabilities;
optimize our manufacturing and procurement processes to predict and control costs;
manufacture and deliver products with good quality in a timely manner and in sufficient quantities;
increase customer awareness and acceptance of our products;
minimize the time and cost required to obtain required regulatory clearances and approvals;
anticipate and compete effectively with other vaccine product developers, manufacturers and marketers;
price our products competitively;
comply with the guidelines of Good Manufacturing Practice, or GMP, and other related regulations; and
thoroughly understand the frequently developing regulatory guidelines and regulations on vaccine products and comply with the regulations and guidelines
accordingly.
We incurred a loss in 2015 as well as in the past years, and may incur losses again in the future.
Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We have incurred substantial losses since
our inception. Although we first became profitable for the year ended December 31, 2007 and were profitable from 2007 through 2009, we incurred losses in
2010, 2011 and 2012. Although we were profitable in 2013, we incurred a loss again in 2014 and 2015. We cannot assure you when we will be profitable again
in the future. We had net income attributable to shareholders of $7.4 million in 2013 and incurred net loss attributable to shareholders of $0.9 million and $1.1
million in 2014 and 2015, respectively. Our profit in 2013 was partly driven by the recognition of H5N1 vaccine governmental stockpiling revenue of $10.7
million, which will not happen every year. In 2014, the loss was caused by less revenue and higher research and development expenses. In 2015, the loss was
caused by the depreciation of RMB against the U.S. dollar and stock-based compensation related to options and restricted shares granted to management and
employees in May 2015. None of the research and development expenses incurred were capitalized in our financial statements. We intend to continue to invest
in research and development to sustain our long-term growth. We expect our research and development expenses to fluctuate depending on the progress we
make on each project, with relatively more spending on clinical studies than preclinical studies. We expect that our spending on research and development will
have a negative impact on our future net earnings. As a result, we may incur losses in the future, which will have an adverse impact on our working capital, total
assets, shareholders’ equity and cash flow.
6
We distribute vaccines product in China through Centers for Disease Control, or CDCs, which are PRC government agencies. This exposes us to risks
relating to doing business with the government.
We sell our vaccines to CDCs, which are PRC government agencies. Our sales to PRC government agencies expose us to various risks relating to doing
business with the government. Demand and ability to pay for our products may be affected by government budgetary cycles, shifting availability of public funds
and changes in policy. Funding reductions, delays in payment or unilateral demands for changes to the terms of our contracts by our government customers
could adversely impact our results of operations and financial condition, exacerbate the existing seasonality of our revenues and make it difficult for us to
allocate resources or anticipate demand for our products. More importantly, we have little or no control over government procurement decisions, and
government agencies that contract to purchase our products may reduce or cancel orders, or demand price adjustments or other changes to their contracts with us
without our consent. Changes in the personnel of the PRC government agencies that purchase our products may result in changes or delays to or cancellations of
purchase commitments due to, among others, differing policy and budgetary agendas of the personnel involved. Similar changes could occur if CDC or other
relevant government agency were to be consolidated with another ministry. Any of the above mentioned actions taken by government agencies could have a
material adverse effect on our results of operations and expected earnings, or result in our failure to meet, or having to adjust downwards, our sales and gross
margin guidance or estimates, which could adversely affect our stock price and result in substantial losses to you. In addition, many of the remedies that are
available to us when dealing with private parties, such as making claims for breach of contract or taking other legal actions, may not be available or practicable
in our dealings with government agencies.
We currently have limited revenue sources. A reduction in revenues from sales of Healive, Bilive or Anflu would cause our revenues to decline and could
materially harm our business.
We generate all of our revenues from sales of our vaccine products. We derive a substantial percentage of our revenues from a small number of vaccine
products. In 2015, 2014 and 2013, 39.8%, 42.1% and 36.8%, respectively, of our revenues were from sales of Healive; 33.5%, 34.9% and 29.0%, respectively,
of our revenues were from sales of Bilive; 18.8%, 19.3% and 16.9%, respectively, of our revenues were from sales of Anflu; and 5.7%, 0.3% and 15.0%,
respectively, of our revenues were from sales of Panflu (H5N1). However, revenue recognition of Panflu (H5N1) is not recurring due to its government
stockpile nature, which may cause fluctuation of our revenue. As a result of this relative lack of product diversification, an investment in our company would be
more risky than investments in companies that offer a wide variety of products or services.
We have already started the commercial production of Enterovirus 71, or EV71, vaccine in 2016, which is estimated to be launched to the market by the end of
the first half of 2016. EV71 vaccine will also serve as one of our core products in the following years.
We expect our key products, which will likely shift over time, to continue to account for a significant portion of our net revenues for the foreseeable future. As a
result, continued market acceptance and popularity of these products are critical to our success and a reduction in demand due to, among other factors, the
introduction of competing products by our competitors, the entry of new competitors, or end-users’ dissatisfaction with the quality of our products, could
materially and adversely affect our financial condition and results of operations.
We could be subject to costly and time-consuming product liability actions and, because our insurance coverage is limited, our exposure to such claims
could cause significant financial burden.
Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of biopharmaceutical products. We
manufacture vaccines that are injected into people to protect against infectious illnesses. If our products do not function as anticipated, whether as a result of
flaws in our design, unanticipated health consequences or side effects, misuse or mishandling by third parties, or faulty or contaminated supplies, they could
harm the vaccinees and, as a result, subject us to product liability lawsuits. Claims against us also could be based on failure to immunize as anticipated. Any
product liability claim brought against us, with or without merit, could have a material adverse effect on us. Meritless and unsuccessful product liability claims
can be time-consuming, expensive to defend and could result in the diversion of management’s attention from managing our core business or result in
associated negative publicity.
7
The successful assertion of product liability claims against us could require us to pay significant monetary damages. Although we currently carry worldwide
product liability insurance for Healive, Bilive, Anflu, Panflu and EV71 vaccine (excluding U.S. and Europe), we cannot assure you that such coverage will be
sufficient to cover any liabilities resulting from successful product liability claims. In such a case, we may be required to make substantial payments to cover
any losses, damages or liabilities arising from product liability claims. For any amounts covered by insurance, there remains the risk that foreign exchange or
other regulatory restrictions may prevent the use of insurance proceeds to meet the liabilities. In addition, we do not have or plan to procure clinical trial liability
insurance for our clinical trials to mitigate any unsuccessful clinical trial expenses or product liability claims arising therefrom. Any of these factors could have
a material adverse effect on our business, financial condition and results of operations.
Any pandemic threat may abate, or alternative vaccines or technologies may be adopted, before our vaccines achieve significant sales.
We have devoted significant resources to researching and developing various vaccines to address the pandemic threat of infectious diseases, including SARS,
avian flu and swine flu, and will continue to devote resources to the development of our vaccines to address any new needs.
However, the threat of a pandemic outbreak may subside before we realize any return on our investment in our research and development. For example,
although we believe we were the first company to complete a phase I clinical trial of an inactivated SARS vaccine in December 2004, we did not proceed with
the phase II and phase III trials as the SARS epidemic subsequently subsided. Other organizations may obtain licenses for their own pandemic vaccines, or
government health organizations may acquire adequate stockpiles of pandemic vaccine or adopt other technologies or strategies to prevent or limit outbreaks
before our pandemic vaccines achieve significant sales. We may not achieve a return on our investment before the threat of a pandemic outbreak subsides or a
competing product is adopted.
Failure to achieve and maintain effective internal controls could have a material adverse effect on our business, results of operations and the trading price
of our common shares.
We are subject to the reporting obligations under U.S. securities laws. Section 404 of the Sarbanes-Oxley Act of 2002 and related rules require public
companies to include a report of management on their internal control over financial reporting in their annual reports. This report must contain an assessment by
management of the effectiveness of a public company’s internal control over financial reporting. In addition, an independent registered public accounting firm
for a public company must attest to and report on the effectiveness of our internal control over financial reporting.
Our management has concluded that our internal control over financial reporting is effective as of December 31, 2015. See “Item 15. Controls and Procedures.”
Our independent registered public accounting firm has issued an attestation report on our internal control over financial reporting, which concludes that our
internal control over financial reporting is effective in all material aspects. However, we cannot assure you that any material weakness or deficiency in our
internal control over financial reporting will not be identified in the future. We may not always be able to maintain an effective internal control over financial
reporting. If we fail to maintain effective internal control over financial reporting in the future, we and our independent registered public accounting firm may
not be able to conclude that we have effective internal control over financial reporting at a reasonable assurance level. This could in turn result in the loss of
investor confidence in the reliability of our financial statements and negatively impact the trading price of our common shares, inhibiting our ability to raise
sufficient capital on favorable terms. Furthermore, we have incurred and anticipate that we will continue to incur considerable costs and to use significant
management time and other resources in an effort to comply with Section 404 and other requirements of the Sarbanes-Oxley Act.
If we are unable to successfully compete in the highly competitive biopharmaceutical industry, our business could be harmed.
We operate in a highly competitive environment and we expect the competition to increase further in the future. Our competitors include large pharmaceutical
and biotechnology companies, both domestic and international. Many of these competitors have greater resources than us. New competitors may also enter into
the markets in which we currently compete. Accordingly, even if we are successful in launching a product, we may not be able to outperform a competing
product for any number of reasons, including the possibility that the competitor may:
have launched its competing product first or the competing product may have, or be perceived as having, better efficacy, stronger brand recognition, or
other advantages;
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have better access to certain raw materials;
have more efficient manufacturing processes and greater manufacturing capacity;
have greater marketing capabilities;
have greater pricing flexibility;
have more extensive research and development and technical capabilities;
have proprietary patent portfolios or other intellectual property rights that may present an obstacle to our conduct of business;
have greater knowledge of local market conditions where we seek to increase our international sales;
have capability to maintain a competitive management team; or
have investment capability to acquire businesses when the opportunity is not available to us.
The technologies applied by our competitors and us are rapidly evolving, and new developments frequently result in price competition and product
obsolescence. In addition, we may be impacted by competition from generic forms of our products, substitute products or imports of products from lower-priced
markets. For a detailed description of our competitors in hepatitis A vaccines, hepatitis A and B vaccines and influenza vaccines, please see “Item 4.
Information on the Company — B. Business Overview — Competition.”
We may not be successful in commercializing our EV71 vaccine.
Our EV71 vaccine was approved for commercialization in China. We obtained the new drug certificate and production license for our proprietary EV71 vaccine
against EV71-associated HFMD from China Food and Drug Administration, or CFDA, on December 30, 2015. CFDA issued the GMP certificate in January
2016. We started the commercial production of our EV71 vaccine immediately and expect to deliver the vaccine to the market in the second quarter of 2016
after the lot release testing is completed. However, there are still risks in the commercialization of EV71 vaccine. Unsuccessful lot release and competitive
pricing pressures may limit or prevent the success of the product on the market. For example, our competitors launched a similar products or the PRC
government may grant compulsory licenses to allow competitors to manufacture our EV71 vaccine. State-owned competitors may not act rationally as
commercial entities, and we may be forced to follow their pricing to the low end of the range. Furthermore, if the PRC government were to include our EV71
vaccine in the Expanded Program on Immunization, or EPI, earlier than we expect, purchase made by the government could affect our anticipated revenue. Any
of these factors, together with other risks, including changes in the regulatory environment, supply issues, product liability claims and failure to win over our
competitors, may result in our inability to successfully commercialize our EV71 vaccine in China, which would materially and adversely affect our business,
financial condition and results of operations.
We may not be able to maintain market share in China with our commercialized vaccines, which could adversely affect our ability to increase our revenues.
Our market share is estimated based on the batch release number for 2015 (as of December 31, 2015) published by the National Institutes for Food and Drug
Control, or NIFDC, which represents the market share estimated based on published supply quantity, but not the actual sales number in the market. We supplied
16.9%, 21.0% and 15.5% of the total hepatitis A vaccine market, or 89.8%, 72.7% and 44.6% of the inactivated hepatitis A vaccine market in 2015, 2014 and
2013, respectively, as measured by lot release number. Going forward, we may not be able to compete with other hepatitis A suppliers for either the private-pay
market or public market, which could adversely affect our ability to increase our revenues from hepatitis A vaccine.
We have been marketing and selling seasonal flu vaccines since 2006. Our market share, in terms of lot release numbers, was 10.9% in 2015, 9.5% in 2014 and
11.3% in 2013. The flu vaccine market in China is highly competitive. Multinational companies are increasing investment in localized flu vaccine
manufacturing plants. Our revenue growth could be adversely impacted if we are not able to maintain our market share in this highly competitive market.
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We may not be able to maintain market share in the government-funded hepatitis A vaccine market, or other government-funded vaccine markets, which
could adversely affect our revenues, and if we do maintain or expand market share in these markets, we may need to sell our vaccines at a lower price,
which could adversely affect our gross margin.
Hepatitis A vaccines have been included in the EPI in China since 2007. The PRC government purchases hepatitis A vaccines for each 18-month-old child.
Although the hepatitis A vaccines have been included in the EPI, most provincial and municipal governments are not able to afford the two shots of inactivated
hepatitis A vaccines due to insufficient financial support, which constrains the purchase of inactivated hepatitis A vaccines in government-funded markets. Most
provincial and municipal governments prefer to purchase the lower-priced live attenuated hepatitis A vaccines; however, a few affluent provincial and
municipal governments, such as Beijing, Tianjin, Shanghai and Jiangsu province, have started to purchase inactivated hepatitis A vaccines. We are supplying
vaccines in these markets at a lower price than we do in the private market, which could adversely affect our gross margin. In addition, we also face competition
from peers who will launch hepatitis A pre-filled syringe in 2016. Our revenue could be adversely impacted if we are not able to maintain our market share of
the government-funded markets in these cities and provinces. As we are making efforts to breakthrough into additional provincial and municipal public markets,
we may be forced to further lower our price to win the tender, which will adversely affect our gross margin.
Since 2007, we have been selected as one of the suppliers by Beijing CDC to supply seasonal influenza vaccines to Beijing citizens. We cannot assure you that
we will continue to obtain orders in the future and maintain the current market share. If the supply volume continues to decrease, it would negatively impact our
sales revenue in the future.
Since 2008, we have received three stockpiling orders for our H5N1 vaccine from China’s central government every two years with the amount of three million
doses per order, and three stockpiling orders from Beijing government with the amount of 20,000 doses per order. The latest batch of stockpiled H5N1 vaccines
will expire in the first half of 2016 and we will recognize the revenue upon the government inspection. We cannot assure you that we will continue to receive
additional stockpiling orders from governments in the future.
If CDCs, hospitals, physicians and vaccinees do not accept our products, we may be unable to generate significant revenue.
Even if we have obtained the regulatory approval for commercialization of our vaccines, they still may not gain market acceptance among CDCs, hospitals,
physicians, vaccinees and the medical community, which would limit our ability to generate revenue and adversely affect our results of operations. CDCs,
hospitals and physicians may not recommend products developed by us or our collaborators until clinical data or other factors demonstrate superior or
comparable safety and efficacy of our products as compared to other available treatments. Even if the clinical safety and efficacy of our products are established,
CDCs, hospitals and physicians may elect not to recommend these products for a variety of reasons. There are other vaccines and treatment options for the
conditions that many of our products and product candidates target, such as hepatitis A and B and influenza. In order to successfully launch a product, we must
educate physicians and vaccinees about the relative benefits of our products. If our products are not perceived as easy and convenient to use, perceived to
present a greater risk of side effects or are not perceived to be as effective as other available treatments, CDCs, hospitals, physicians and vaccinees might not
adopt our products. A failure of our products to gain commercial acceptance would have a material adverse effect on our business, financial condition and
results of operations.
We may not achieve the expected return on our investment in Sinovac (Dalian) Vaccine Technology Co., Ltd., or Sinovac Dalian.
We have invested significant resources into Sinovac Dalian since its establishment in 2010. However, we cannot assure you that Sinovac Dalian’s business,
covering the research, development, manufacturing and commercialization of vaccines, such as mumps and varicella, will be successful or that we will not incur
any related impairment charges in the future. Any failure to achieve the expected return on our investment in Sinovac Dalian may materially and adversely
affect our business, financial condition and results of operations.
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Our growth may be adversely affected if market demand for our vaccine products and product candidates does not meet our expectations. We may
encounter problems of inadequate supply or oversupply, which would materially and adversely affect our financial condition and results of operations and
would also damage our reputation and brand.
Our growth may be adversely affected if market demands for our vaccine products and product candidates do not meet our expectations. The production of
vaccine products is a lengthy and complex process. As a result, our inability to match our production to market demand may result in a failure to meet market
demand, which could materially and adversely affect our financial condition and results of operations and could also damage our reputation and corporate brand.
For example, many vaccinees receive their seasonal flu vaccinations in the three-month period from September to November in anticipation of an upcoming flu
season and we expect this period to be one of the most significant sales periods for this product each year. In anticipation of the flu season, we intend to build up
inventory of our Anflu product in line with what we believe will be the anticipated demand for the product. If actual demand does not meet our expectations, we
may be required to write off significant inventory and may otherwise experience adverse consequences in our financial condition. If we overestimate demand,
we may purchase more raw materials than required. If we underestimate demand, our third-party suppliers may have inadequate raw material inventories, which
could interrupt our manufacturing, delay shipments and result in lost sales.
If we are unable to enroll sufficient vaccinees and identify clinical investigators for our clinical trials, our development programs could be delayed or
terminated.
The rate of completion of our clinical trials is significantly dependent upon the rate of enrollment of volunteers. Vaccinees enrollment is a function of many
factors, including:
efforts of the sponsor and clinical sites involved to facilitate timely enrollment;
vaccinee referral practices of physicians;
design of the protocol;
eligibility criteria for the study in question;
perceived risks and benefits of the drug under study;
the size of the vaccinee population;
availability of competing therapies;
availability of clinical trial sites; and
proximity of and access by vaccinees to clinical sites.
We may have difficulty in obtaining sufficient volunteer subjects enrollment or finding qualified investigators to conduct our clinical trials as planned and we
may need to expend substantial funds to obtain access to resources or delay or modify our plans significantly. These considerations may lead us to consider the
termination of development of a product for a particular indication.
A setback in any of our clinical trials could adversely affect our share price.
We obtained the approval to conduct clinical trials for our pneumococcal polysaccharide vaccine, varicella vaccine and sabin-inactivated polio vaccine, or sIPV
vaccine, in May 2014, October 2015 and December 2015, respectively. We started clinical trials for pneumococcal polysaccharide vaccine at the beginning of
April 2015. Setbacks in any phase of the clinical trials of our product candidates could have a material adverse effect on our business and our future prospects
and financial results and would likely cause a decline in the price of our common shares. We may not achieve our projected development goals in the time
frames we announce and expect. If we fail to achieve one or more milestones as contemplated, the market price of our common shares could decline.
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We set goals for and make public statements regarding our anticipated timing of the accomplishment of objectives material to our success, such as the
commencement and completion of clinical trials and other milestones. The actual timing of these events can vary significantly due to factors such as delays or
failures in our clinical trials, the uncertainties inherent in the regulatory approval process and delays in achieving manufacturing or marketing arrangements
sufficient to commercialize our products. We may not complete our clinical trials or make regulatory submissions or receive regulatory approvals as planned.
Also, we may not be able to adhere to our currently anticipated schedule for the launch of any of our products. If we fail to achieve one or more milestones as
contemplated, the market price of our shares could decline.
We rely on third parties to conduct clinical trials, who may not perform their duties satisfactorily.
After we obtain approval to conduct clinical trials for our product candidates, we rely on qualified research organizations, medical institutions and clinical
investigators to enroll qualified vaccinees and conduct clinical trials. Our reliance on these third parties for clinical development activities reduces our control
over the clinical trial process. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these
third parties do not fulfill their contractual obligations, including failing to meet expected deadlines, we may not succeed or may experience delays in our efforts
to obtain regulatory approvals and commercialize our vaccine candidates.
If any of our third-party suppliers or manufacturers cannot adequately meet our needs, our business could be harmed.
While we use raw materials and other key material supplies that are generally available from multiple commercial sources, certain raw materials that we use to
cultivate our influenza vaccines, such as embryonated eggs, are in short supply or difficult for suppliers to produce in accordance with our specifications. If the
third-party suppliers were to cease production or otherwise fail to supply us with quality raw materials, and if we were unable to contract on acceptable terms
for these materials with alternative suppliers, our ability to deliver our products to the market would be adversely affected.
In addition, if we fail to secure long-term supply sources for some of the raw materials we use, our business could be harmed. For example, we do not have a
long-term agreement for the supply of hepatitis B antigens used for Bilive production. We source hepatitis B antigens entirely from Beijing Temple of Heaven
Biological Products Co., Ltd., or Beijing Temple of Heaven. Although we are developing our own hepatitis B vaccine, before it is approved to be
commercialized, we have to rely on the supplier to receive hepatitis B antigen. We and Beijing Temple of Heaven agreed to enter into annual hepatitis B
antigens supply agreements after our previous ten-year exclusive supply framework agreement expired in October 2012. Beijing Temple of Heaven supplied
hepatitis B antigens to us from July 2013 to June 2015 based on the annual supply agreement. Thereafter, Beijing Temple of Heaven ceased its hepatitis B
antigens production due to facilities renovation until 2017. To ensure sufficient storage, we procured an abundant amount of hepatitis B antigens from Beijing
Temple of Heaven and produced a significant amount of Bilive in 2015. Although we are confident that we can maintain sufficient supply of Bilive until Beijing
Temple of Heaven resumed its production of hepatitis B antigens, we cannot assure you that Beijing Temple of Heaven will not, for any reason, delay its
renovation schedule and cease to supply us with hepatitis B antigens in the future, in which case our business, financial condition and results of operations may
be materially and adversely affected.
From time to time, concerns are raised with respect to potential contamination of biological materials that are supplied to us. These concerns can further tighten
market conditions for materials that may be in short supply or available from limited sources. Moreover, regulatory approvals to market our products may be
conditioned upon obtaining certain materials from specified sources. Any efforts to substitute material from an alternate source may be delayed by pending
regulatory approval of such alternate source. Although we work to mitigate the risks associated with relying on sole suppliers, there is a possibility that material
shortages could impact product development and production.
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Our business is highly seasonal. This seasonality will contribute to our operating results fluctuating considerably throughout the year.
Our business is highly seasonal. For example, the influenza season generally runs from November through March of the next year and the largest percentage of
influenza vaccinations is administered between September and November of each year. As a result, we expect to realize most of our annual revenues from Anflu
during this period. This seasonality in our business is expected to contribute to significant quarterly fluctuations in our operating results.
We rely on a limited number of facilities for the manufacturing of our products in accordance with relevant regulatory requirements. Any disruption to our
existing manufacturing facilities or in the development of new facilities could reduce or restrict our sales and harm our reputation.
According to the China GMP guidelines, each vaccine products can only be produced in one dedicated production facility. In Beijing, we conduct the primary
production of each vaccine in its dedicated production plant at our Shangdi site and secondary filling and packaging at our Changping site. In Dalian, we
manufacture mumps vaccine at one facility. We also conduct some of our primary research and development activities out of our manufacturing facilities. We
do not maintain back-up facilities for our currently available products, so we are dependent on our existing facilities for the continued operation of our business.
A natural disaster or other unanticipated catastrophic events, including power interruptions, water shortages, storms, fires, earthquakes and terrorist attacks,
could significantly impair our ability to manufacture our products and operate our business and could also delay our research and development activities. Our
facilities and certain equipment located in these facilities would be difficult to replace and could require substantial replacement lead-time. Catastrophic events
may also destroy any inventory located in our facilities. We do not maintain any business interruption insurance to cover lost income as a result of any such
events. The occurrence of such events could materially and adversely affect our business. We may build additional manufacturing facilities in the future. There
can be no assurance, however, that we will be able to expand our manufacturing capabilities to or realize the anticipated benefits of our new facilities. Any of
these factors could reduce or restrict our sales, harm our reputation and have a material adverse effect on our business, financial condition, results of operations
and prospects.
We will need additional capital to upgrade the production plant for our existing products or expand the facility, to continue development of our product
pipeline and to market existing and future products on a large scale. We cannot guarantee that we will find adequate sources of capital in the future.
We closed a public offering of our common shares on February 2, 2010, and received net proceeds of approximately $61.8 million, after deducting underwriting
discounts and commissions and offering expenses payable by us. We have invested approximately $16.4 million in incorporation of Sinovac Dalian and
invested $25.4 million in Beijing Sinovac R&D Technology Co. Ltd. or Sinovac R&D to conduct research and development and other operating activities of
operational entity in PRC. We intend to use the remaining net proceeds we received from this offering for the research and development of our product
candidates and other general corporate purposes.
In the long run, we will need to raise additional funds to finance equipment expenditures, to acquire intellectual property, to expand the production facility for
our pipeline products, including pneumococcal polysaccharide vaccine and varicella vaccine, to continue the development and commercialization of our product
candidates and for other corporate purposes. As of December 31, 2015, we had approximately $63.8 million in cash and cash equivalents. Although we believe
that we have adequate near-term cash resources, we will need to undertake significant future financings in order to:
establish and expand manufacturing capabilities;
proceed with the research and development of other vaccine products, including clinical trials of new products;
commercialize our products, including the marketing and distribution of new and existing products;
seek and obtain regulatory approvals;
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develop or acquire directly, or indirectly through acquisition of companies, other product candidates or technologies or companies;
protect our intellectual property; and
finance general, administrative and research activities that are not related to specific products under development.
In the past, we funded most of our research and development and other expenditures through government grants, working capital, bank loans and proceeds from
private placements and public offering of our common shares. We may raise additional funds in the future because our current operating and capital resources
may be insufficient to meet future requirements.
If we continue to raise additional funds by issuing equity securities, it will result in further dilution to our existing shareholders because the shares may be sold
at a time when the market price is low and shares issued in equity financing transactions will normally be sold at a discount to the current market price. Any
additional equity securities issued also may provide for rights, preferences or privileges senior or otherwise preferential to those of holders of our existing
common shares. Unforeseen problems including materially negative developments relating to, among other things, disease developments, product sales, new
product rollouts, clinical trials, research and development programs, our strategic relationships, our intellectual property, litigation, regulatory changes in our
industry, the Chinese market generally or general economic conditions, could interfere with our ability to raise additional funds or materially and adversely
affect the terms upon which such funding is available.
If we raise additional funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our
common shares, and the terms of the debt securities issued could impose significant restrictions on our operations. If we raise additional funds through
collaborations and licensing arrangements, we might be required to relinquish significant rights to certain of our technologies, marketing territories, product
candidates or products that we would otherwise seek to develop or commercialize ourselves, or be required to grant licenses on terms that are not favorable to
us. In the past, we have also received different types of grants from the PRC government to finance the research and development and facility investment of our
vaccine products. We may not receive additional grants in the future.
We do not know whether additional financing will be available to us on commercially acceptable terms when needed. If adequate funds are not available or are
not available on commercially acceptable terms, we may be unable to continue developing our products. In any such event, our ability to bring a product to
market and obtain revenues could be delayed and competitors could develop products sooner than we do. As a result, our business, financial condition and
results of operations could be materially and adversely affected.
The interests of the respective minority shareholders of Sinovac Biotech Co., Ltd., or Sinovac Beijing, and Sinovac Dalian may diverge from our own, which
may adversely affect our ability to manage these subsidiaries.
Sinovac Beijing, our principal operating subsidiary, is a Sino-foreign equity joint venture in which we own a 73.09% interest and Sinobioway Bio-medicine Co.,
Ltd. (formerly named Xiamen Bioway Group Co., Ltd), or Sinobioway Medicine, owns a 26.91% interest. Sinobioway Medicine’s interests may not be aligned
with our interests at all times. We cannot assure you that Sinobioway Medicine will be cooperative with us in handling matters related to the operations of
Sinovac Beijing. As the minority shareholder of Sinovac Beijing, according to Sinovac Beijing’s articles of association, Sinobioway Medicine has the right to
assign a director to the five-director board of Sinovac Beijing. Accordingly, they have the ability to take actions that bind Sinovac Beijing or to block any action
that requires unanimous board approval. In addition, if we wish to transfer our equity interest in Sinovac Beijing, in whole or in part, to a third party,
Sinobioway Medicine has a right of first refusal to purchase our interest in accordance with the relevant PRC regulations.
In addition, Sinobioway Medicine, the minority shareholder of Sinovac Beijing, has additional rights under the joint venture contract and articles of association
of Sinovac Beijing. The joint venture contract and articles of association require the consent of each of Sinovac Beijing’s shareholders and/or unanimous board
approval on matters such as a major change in the business line of the company, expansion or amendment of the business scope of the company, transfer of the
registered capital by a shareholder, creation of a mortgage or pledge upon the company’s assets, a change in the organizational form of the company and
designation or removal of the general manager.
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In November 2009, we entered into an agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, Sinovac Dalian was established to
focus on the research, development, manufacturing and commercialization of vaccines, such as mumps and varicella for human use. Pursuant to the joint
venture agreement, we made the initial cash contribution of RMB60.0 million ($9.3 million) in exchange for a 30% equity interest in Sinovac Dalian, and
Dalian Jin Gang Group made an asset contribution of RMB140.0 million ($21.6 million), including the manufacturing facilities, production lines and land use
rights, in exchange for the remaining 70% interest in Sinovac Dalian. In December 2010, we purchased an additional 25% equity interest in Sinovac Dalian
from Dalian Jin Gang Group with a consideration of RMB50.0 million ($7.7 million). We and Dalian Jin Gang Group currently own 55% and 45% equity
interests in Sinovac Dalian, respectively.
To date, Dalian Jin Gang Group has been cooperative with us in handling matters with respect to the business of Sinovac Dalian. We cannot assure you,
however, that Dalian Jin Gang Group will continue to act in a cooperative manner in the future.
Under China’s joint venture regulations, the unanimous approval of members of a joint venture’s board of directors who are present at a board meeting is
required for any amendment to the joint venture’s articles of association, the termination or dissolution of the joint venture company, an increase or decrease in
the registered capital of the joint venture company or a merger or de-merger of the joint venture. If our interests diverge from those of our minority
shareholders, they may exercise their rights under PRC laws to protect their own interests, which may be adverse to ours. As a result, our ability to manage these
subsidiaries may be adversely affected, which in turn may materially and adversely affect our business, financial condition and results of operations.
Some of the predecessor shareholders of Sinovac Beijing and Tangshan Yian were enterprises owning state-owned assets, or EOSAs. Their failures to
comply with PRC legal requirements in asset or share transfers could, under certain circumstances, result in such transfers being invalidated by
government authorities. If this occurs, we could lose our ownership of intellectual property rights that are vital to our business as well as our equity
ownership in Sinovac Beijing and Tangshan Yian.
Sinovac Beijing is currently owned 73.09% by us and 26.91% by Sinobioway Medicine (formerly named Xiamen Bioway Group Co., Ltd). The technologies
related to hepatitis A vaccine, hepatitis A and B vaccine and influenza vaccine that are vital to our business were directly or indirectly transferred to us by
Tangshan Yian. Some of the predecessor shareholders of Sinovac Beijing and Tangshan Yian, including Shenzhen Kexing Biological Engineering Ltd., or
Shenzhen Kexing, Sinobioway Medicine, Tangshan Medicine Biotech Co., Ltd., Tangshan Yikang Biotech Co., Ltd. and Tangshan Yian itself (as Sinovac
Beijing’s former shareholder), were EOSAs. Under applicable PRC laws, when EOSAs sell, transfer or assign assets or equity investments in their possession or
under their control to third parties, they are required to obtain an independent appraisal of the transferred assets or shares and file such appraisal with or obtain
approval of such appraisal from PRC government authorities. Since 2004, EOSAs have also been required to make such assets or equity transfers at
government-designated marketplaces. Our acquisitions of intellectual property rights and some equity interests were subject to these requirements.
Tangshan Yian failed to file with the government authorities the appraisal of the hepatitis A vaccine technology that it transferred to Sinovac Beijing in 2001 as
its capital contribution to Sinovac Beijing. Under PRC laws, Tangshan Yian also failed to:
obtain the appraisal of the hepatitis A and B vaccine technology that it transferred for no consideration to Beijing Keding Investment Co., Ltd., or
Beijing Keding, in 2002 (Beijing Keding subsequently transferred the technology to Sinovac Beijing as Beijing Keding’s capital contribution to
Sinovac Beijing) and to file such appraisal with the government authorities; and
obtain the appraisal of the influenza vaccine technology that it transferred to Sinovac Beijing in 2004 and to file such appraisal with the government
authorities.
These failures subject us to the risk of losing ownership or control of these vaccine technologies.
In addition, before we acquired our 73.09% equity interest in Sinovac Beijing, it had undergone multiple changes in its shareholders and these shareholders’
shareholdings. Some of the EOSA shareholders of Sinovac Beijing have sold, transferred or assigned their respective equity interests in Sinovac Beijing without
fully complying with laws to appraise the equity interests, to file such appraisals with or obtain regulatory approval of such appraisals from PRC government
authorities or to make equity interest transfers at the government-designated marketplaces as required for transactions completed after 2004. Similar to the asset
transfers, such failures subject us to the risk of losing the ownership or control of our equity interest in Sinovac Beijing.
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PRC government authorities may take court actions to invalidate the transfers of the assets or equity investments discussed above for non-compliance with
applicable appraisal, filing, approval and designated marketplace requirements. We cannot guarantee that the government authorities will not take such legal
actions or that such legal actions, if commenced, will not be successful. If these transfers are invalidated, we would lose title to these assets and investments.
Because we depend on these technologies and because Sinovac Beijing constitutes core part of our operations, our loss of these technologies or equity interest in
Sinovac Beijing would materially and adversely affect our business operations and financial condition.
There can be no assurance that the going private transaction will be successfully consummated. Potential uncertainty involving the going private
transaction may adversely affect our business and the market price of our common shares.
Our board of directors received a non-binding proposal letter, dated January 30, 2016, from Mr. Weidong Yin, our chairman, president and chief executive
officer, SAIF Partners IV L.P. and/or its affiliates, to acquire all of our outstanding common shares not owned by them or their affiliates for $6.18 in cash per
common share, subject to certain conditions. Following receipt of the proposal, our board of directors formed a special committee of independent directors to
consider the proposal. The special committee received a competing non-binding going private proposal letter, dated February 3, 2016, from a consortium
comprised of PKU V-Ming (Shanghai) Investment Holdings Co., Ltd., Shandong Sinobioway Biomedicine Co., Ltd., CICC Qianhai Development (Shenzhen)
Fund Management Co., Ltd., Beijing Sinobioway Group Co., Ltd., Heng Feng Investments (International) Limited and Fuerde Global Investment Limited, to
acquire our outstanding common shares for $7.00 in cash per common share, subject to certain conditions. The special committee will carefully consider and
evaluate both proposals and other alternative proposals with the assistance of the special committee’s independent advisors appointed. The going private
transaction, whether or not consummated, presents a risk of diverting management focus, employee attention and resources from other strategic opportunities
and from operational matters. Potential uncertainty involving the going private transaction may adversely affect our business and the market price of our
common shares.
Our shareholder rights plan and certain provisions of our By-laws may discourage a change of control.
In March 2016, we adopted a shareholder rights plan, or the “Rights Plan”, that provides for one right, or the Right, for each of our outstanding common shares.
The rights are designed to assure that all of our shareholders receive fair and equal treatment in the event of any proposed takeover and to guard against partial
tender offers, open market accumulations and other abusive or coercive tactics to gain control of our company without paying all shareholders a control
premium. The rights will cause substantial dilution to a person or group that acquires 15% or more of the common shares on terms not approved by our board of
directors.
Some provisions of our By-laws may discourage, delay or prevent a change in control of our company or management that shareholders may consider favorable,
including provisions that authorize our board of directors to issue preferred shares in one or more series and to designate the price, rights, preferences, privileges
and restrictions of such preferred shares without any further vote or action by our shareholders.
These provisions could make it more difficult for a third party to acquire us, even if the third party’s offer may be considered beneficial by many shareholders.
As a result, shareholders may be limited in their ability to obtain a premium for their shares.
We depend on our key personnel, the loss of whom would adversely affect our operations. If we fail to attract and retain the talent required for our business,
our business will be materially harmed.
We are a small company with 646 full-time employees as of December 31, 2015 and we depend to a great extent on principal members of our management and
scientific teams. If we lose the services of any key personnel, in particular Mr. Weidong Yin, the loss could significantly impede the key decision making on
strategic choices and operational issues, which in turn will harm our business achievement. We do not currently have any key man life insurance policies. We
have entered into employment agreements with our executive officers, under which they have agreed to restrictive covenants relating to non-competition and
non-solicitation. These employment agreements do not, however, guarantee that we will be able to retain the services of our executive officers in the future. In
addition, recruiting and retaining additional qualified scientific, technical and managerial personnel and research partners will be critical to our success.
Competition among biopharmaceutical and biotechnology companies for qualified employees in China is intense and turnover rates are high. There is currently
a shortage of employees in China with expertise in our areas of research and clinical and regulatory affairs, and this shortage is likely to continue. We may not
be able to retain existing personnel or attract and retain qualified staff in the future. If we fail to hire and retain personnel in key positions, we may be unable to
develop or commercialize our product candidates in a timely manner.
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We may encounter difficulties in managing our growth, which could adversely affect our results of operations.
We have experienced a period of rapid and substantial growth and, if such growth continues, will continue to place a strain on our administrative and
operational infrastructure. We also plan to introduce new products to market that, if successful, could place a strain on our administrative and operational
infrastructure. If we are unable to manage this growth effectively, our business, results of operations or financial condition may be materially and adversely
affected. Our ability to manage our operations and growth effectively requires us to continue to improve our operational, financial and management controls,
reporting systems and procedures and hiring programs. We may not be able to successfully implement these required improvements.
International expansion may be costly, time-consuming and difficult. If we do not successfully expand internationally, our growth strategy and prospects
would be materially and adversely affected.
We have entered into selected international markets and intend to continue to expand the sales of our products into new international markets. In expanding our
business internationally, we have entered, and intend to continue to enter, markets in which we have limited or no experience and in which our brand may be
less recognized. To further promote our brand and generate demand for our products so as to attract distributors in international markets, we expect to spend
significantly more on marketing and promotion than we do in our existing domestic markets when appropriate. We may be unable to attract a sufficient number
of distributors, and our selected distributors may not be suitable for selling our products. Furthermore, in new markets, we may fail to anticipate competitive
conditions that are different from those in our existing markets. These competitive conditions may make it difficult or impossible for us to effectively operate in
these markets. If our expansion efforts in existing and new internal markets are unsuccessful, our growth strategy and prospects would be materially and
adversely affected.
We are exposed to other risks associated with international operations, including:
political instability;
economic instability and recessions;
changes in tariffs;
difficulties of administering foreign operations generally;
limited protection for intellectual property rights;
obligations to comply with a wide variety of foreign laws and other regulatory approval requirements;
increased risk of exposure to terrorist activities;
financial condition, expertise and performance of our international distributors;
export license requirements;
unauthorized re-export of our products;
potentially adverse tax consequences;
inability to effectively enforce contractual or legal rights; and
exchange rate fluctuation, devaluation of foreign currencies.
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We may undertake acquisitions which may have a material adverse effect on our ability to manage our business and may end up being unsuccessful.
Our growth strategy may involve the acquisition of new production lines, technologies, businesses, products or services or the creation of strategic alliances in
areas in which we do not currently operate. These acquisitions could require that our management develop expertise in new areas, new geographies, manage
new business relationships and attract new types of customers. Furthermore, acquisitions may require significant attention from our management, and the
diversion of our management’s attention and resources could have a material adverse effect on our ability to manage our business. We may also experience
difficulties integrating acquisitions into our existing business and operations. Future acquisitions may also expose us to potential risks, including risks associated
with:
the integration of new operations, services and personnel;
unforeseen or hidden liabilities;
the diversion of resources from our existing businesses and technologies;
our inability to generate sufficient revenue to offset the costs of acquisitions;
potential loss of, or harm to, relationships with employees or customers, any of which could significantly disrupt our ability to manage our business and
materially and adversely affect our business, financial condition and results of operations; and
impairment of intangible assets acquired.
We may be unable to ensure compliance with United States economic sanctions laws, especially when we sell our products to distributors over which we
have limited control.
The U.S. Department of the Treasury’s Office of Foreign Assets Control administers certain laws and regulations that impose penalties upon U.S. persons and,
in some instances, foreign entities owned or controlled by U.S. persons, for conducting activities or transacting business with certain countries, governments,
entities or individuals subject to U.S. economic sanctions, or U.S. Economic Sanctions Laws. We will not use any proceeds, directly or indirectly, from sales of
our common shares, to fund any activities or business with any country, government, entity or individual with respect to which U.S. persons or, as appropriate,
foreign entities owned or controlled by U.S. persons, are prohibited by U.S. Economic Sanctions Laws from conducting such activities or transacting such
business. However, we sell our products in international markets through independent non-U.S. distributors which are responsible for interacting with the end-
users of our products. We may not be able to ensure that such non-U.S. distributors comply with all applicable U.S. Economic Sanctions Laws. Moreover, if a
U.S. distributor conducts activities or transacts business with a country, government, entity or individual subject to U.S. economic sanctions, such actions may
violate U.S. Economic Sanctions Laws. As a result of the foregoing, actions could be taken against us that could materially and adversely affect our reputation
and have a material adverse effect on our business, financial condition, results of operations and prospects.
Failure to comply with the U.S. Foreign Corrupt Practices Act and other applicable anti-corruption laws could subject us to penalties and other adverse
consequences and corrupt practices by our competitors may place us at a competitive disadvantage.
Our executive officers, employees and other agents may violate applicable laws in connection with the marketing or sale of our products, including the U.S.
Foreign Corrupt Practices Act, or the FCPA, and applicable anti-corruption laws in China and other jurisdictions in which our products are sold or registered for
sale. The FCPA generally prohibits United States issuers from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining
or retaining business and requires issuers to maintain reasonable internal controls. The PRC also strictly prohibits bribery of government officials. We have
adopted a policy regarding compliance with the FCPA and other applicable anti-corruption laws to prevent, detect and correct such corrupt practice. However,
corruption, extortion, bribery, pay-offs, theft and other fraudulent practices occur from time to time in the PRC and the countries in which we seek to do
business. While we have implemented measures to ensure compliance with the FCPA and other applicable anti-corruption laws by all individuals involved with
our company, it is possible that our compliance policies and procedures may be insufficient or may fail to prevent our employees or other agents from engaging
in inappropriate conduct for which we might be held responsible. If our employees or other agents are found to have engaged in such practices, we could suffer
severe penalties and other consequences that may have a material adverse effect on our business, financial condition and results of operations. In addition, our
brand and reputation, our sales activities or the price of our common shares could be adversely affected if we become the target of any negative publicity as a
result of actions taken by our employees or other agents.
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In addition, there may be corrupt practices in the healthcare industry in China and other countries in which we conduct business. For example, in order to secure
agreements with CDCs or hospitals in China, our competitors may engage in corrupt practices in order to influence decision-makers in violation of the anti-
corruption laws of China and the FCPA. As competition persists and intensifies in our industry, we may lose potential clients, client referrals and other
opportunities to the extent that our competitors engage in such practices or other illegal activities.
We may become a passive foreign investment company, which could result in adverse U.S. federal income tax consequences to U.S. Holders of our common
shares.
Based on the market price of our common shares, the value of our assets and the composition of our income and assets, we do not believe we were a “passive
foreign investment company,” or PFIC, for U.S. federal income tax purposes for our taxable year ended December 31, 2015. A non-U.S. corporation will be a
PFIC for any taxable year if either (i) at least 75% of its gross income for such year is passive income or (ii) at least 50% of the value of its assets (based on an
average of the quarterly values of the assets) during such year is attributable to assets that produce passive income or are held for the production of passive
income. We must make a separate determination after the close of each year as to whether we were a PFIC for that year. The composition of our income and
assets will be affected by how, and how quickly, we use any cash we generate from our operations or raise in any offering. Because the value of our assets for
purposes of the PFIC test will generally be determined by reference to the market price of our common shares, fluctuations in the market price of our common
shares may cause us to become a PFIC for any subsequent year. If we are a PFIC for any year during which a U.S. Holder (as defined in “Item 10. Additional
Information — E. Taxation — United States Federal Income Taxation”) holds our common shares, certain adverse U.S. federal income tax consequences could
apply to such U.S. Holder. Please see “Item 10. Additional Information — E. Taxation — United States Federal Income Taxation — Passive Foreign
Investment Company.”
Negative publicity regarding vaccinations in China may lead to lower demand for vaccination, which could in turn negatively affect our business, financial
condition and results of operations.
In December 2013, it was reported that several infants died shortly after receiving inoculations of hepatitis B vaccine produced by a domestic company in
China. The CFDA and National Health and Family Planning Commission have determined that the inoculated hepatitis B vaccines comply with the applicable
regulatory standards. In March 2016, media reposted on improperly stored vaccines illegally sold in Shandong province and all across China. The illegal
distribution started in 2010 and two suspects were detained by police in 2015. Although experts from the World Health Organization, or WHO, has confidence
in China’s vaccine industry and publicly clarified their position several times since news of this scandal broke, public concerns remain. Such negative publicity
may lead to lower demand for vaccination in China, which could in turn negatively affect the vaccine industry and our business, financial condition and results
of operations.
Risks Related to Government Regulation
We may not be able to comply with applicable GMP standards and other regulatory requirements, which could have a material adverse effect on our
business, financial condition and results of operations.
We are required to comply with applicable GMP regulations, which include, among other things, requirements relating to personnel, premises and equipment,
raw material and products, qualification and validation, documents management, production management, quality control and assurance and products
distribution and recall. Manufacturing facilities must be approved by governmental authorities before they can be used to commercially manufacture our
products and are subject to inspection by regulatory agencies. We have been required to comply with the new GMP standards implemented by CFDA since
March 1, 2011. The new GMP standards are similar to EU GMP standards. All vaccine manufacturers were required to meet the new GMP standards and obtain
certifications for their manufacturing facilities by December 31, 2013. Any manufacturer that failed to meet the deadline will be forced to suspend production.
We have obtained the new GMP certificates for all of our commercial production facilities. However, we cannot assure you that we will be able to continue to
meet the applicable GMP standards and other regulatory requirements in the future. In addition, in light of the recent incident where vaccines were illegally sold
and distributed in Shandong province and other provinces around China, the government may change policies and regulations related to the vaccine sales and
distribution in China. We are not able to estimate the impact of such changed policies and regulations on our business.
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If we fail to comply with applicable regulatory requirements at any stage during the regulatory process, including following any product approval, we may be
subject to sanctions, including:
fines;
product recalls or seizures;
injunctions;
refusal of regulatory agencies to review pending market approval applications or supplements to approval applications;
total or partial suspension of production;
civil penalties;
withdrawals of previously approved marketing applications; and
criminal prosecution.
We can only sell products that have received regulatory approvals. Many factors affect our ability to obtain such approvals.
Pre-clinical and clinical trials of our products, and the manufacturing and marketing of our technologies, are subject to extensive, costly and rigorous regulation
by governmental authorities in the PRC and in other countries. Even if we complete pre-clinical and clinical trials successfully, we may not be able to obtain
applicable regulatory approvals. We cannot market any product candidate until we have both completed our clinical trials and obtained the necessary regulatory
approvals for that product candidate.
Conducting clinical trials and obtaining regulatory approvals are uncertain, time-consuming and expensive processes. The process of obtaining required
regulatory approvals from the CFDA and other regulatory authorities often takes many years and can vary significantly based on the type, complexity and
novelty of the product candidates. For example, it took us approximately ten years to develop and obtain regulatory approval to commercialize Healive, and it
took us five and a half years and four and a half years, respectively, to develop and obtain regulatory approvals to commercialize Bilive and Anflu. EV71
vaccine, above all, took us eight years from 2008 to 2016 to develop and obtain regulatory approvals.
There can be no assurance that all of the clinical trials pertaining to our vaccines in development will be completed within the timeframes currently anticipated
by us. We could encounter difficulties in enrolling vaccinees for clinical trials or encounter setbacks while conducting clinical trials that result in delays or
cancellation. Data obtained from pre-clinical and clinical studies are subject to varying interpretations that could delay, limit or prevent regulatory approval, and
failure to observe regulatory requirements or inadequate manufacturing processes are examples of other problems that could prevent approval. In addition, we
may encounter delays or rejections in the event of additional regulation from future legislation, administrative action or changes in the CFDA policy or if
unforeseen health risks become an issue with the participants of clinical trials. Clinical trials may also fail at any stage. Results of early trials frequently do not
predict results of later trials, and acceptable results in early trials may not be repeated. For these reasons, we do not know whether regulatory authorities will
grant approval for any of our product candidates in the future. In addition, production permits for our products are valid for only five years and we need to apply
for renewal six months prior to their expirations. The approving process for our renewal applications could be lengthy and there is no assurance that we will be
granted renewal in a timely manner or at all.
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Delays in obtaining the CFDA or foreign approvals of our products could result in substantial additional costs and adversely affect our ability to compete with
other companies. Even if regulatory approval is ultimately granted, there can be no assurance that we can maintain the approval or that the approval will not be
withdrawn. Any approval received may also restrict the intended use and marketing of the product we want to commercialize.
Outside the PRC, our ability to market any of our potential products is contingent upon receiving marketing authorizations from the appropriate foreign
regulatory authorities. These foreign regulatory approval processes include all of the risks associated with the CFDA approval process described above and may
include additional risks.
Because the medical conditions that our vaccines are intended to prevent represent significant public health threats, we are at risk of governmental actions
detrimental to our business, such as product seizure, compulsory licensing, resumed price controls and additional regulations.
In response to a pandemic or the perceived risk of a pandemic, governments in the PRC and other countries may take actions to protect their citizens that could
affect our ability to control the production and export of pandemic vaccines or otherwise impose burdensome regulations on our business. For example, an
outbreak of influenza could subject our manufacturing locations to seizure by the PRC government. The PRC government may also grant compulsory licenses
to allow competitors to manufacture products that are protected by our patents, use our technology developed using funds received from government agencies or
resume its price control over vaccines although such control has recently been lifted in China.
We deal with hazardous materials that may cause injury to others. These materials are regulated by environmental laws that may impose significant costs
and restrictions on our business.
Our research and development programs and manufacturing operations involve the controlled use of potentially harmful biological materials and other
hazardous materials. We cannot completely eliminate the risk of accidental contamination or injury to our employees or others from the use, manufacture,
storage, handling or disposal of hazardous materials and certain waste products. In the event of contamination or injury, we could be held liable for any resulting
damages, and any liability could exceed our resources or any applicable insurance coverage we may have. We are also subject to PRC laws and regulations
governing the construction and operation of production facilities that may have an impact on the environment and the use, manufacture, storage, handling or
disposal of hazardous materials and waste products, such as the PRC Environmental Impact Assessment Law, the PRC Prevention and Control of Water
Pollution Law and the PRC Environmental Protection Law, as well as waste-disposal standards set by the relevant governmental agencies. It is likely that China
will adopt stricter pollution controls as the country is experiencing increasingly serious environmental pollution. Although we passed an environmental
examination of our facilities conducted in 2004 by the Beijing Municipal Environment Protection Bureau on our hepatitis A vaccine production line and passed
the same examination on our seasonal flu vaccine production line and filling and packaging line in 2005 and 2008, respectively, we cannot assure you that we
will continue to pass similar environmental examinations on any future production facilities that we may construct. In addition, according to the PRC
Environmental Impact Assessment Law, after the approval of previous environmental impact assessment report, if there is any material change in the nature,
scale, location, production technology used and measures adopted to prevent damages to ecology, new environmental impact assessment reports need to be filed
for approval. We have already obtained the approval of the environmental impact assessment report from the Beijing Municipal Environment Protection Bureau
for the construction plan of our facilities in Changping District, Beijing. We currently produce Bilive vaccine at our production facility for hepatitis A vaccine
and produce Panflu and Panflu.1 vaccines at our production facility for seasonal flu or Anflu vaccine. We have canceled the construction plan for influenza
vaccine production facility. New environmental impact assessment report regarding the change has been submitted to the relevant environment protection
authorities and has passed the government inspection. We also added an sIPV production facility to the Changping construction plan and are in the stage of
filing the relevant environmental impact assessment report. In addition, we have obtained approval for the environmental impact assessment report for PPV
production facility at our Shangdi site and completed the construction. We are required to pass the government inspection so as to launch the commercial
production of PPV. If we fail to pass the inspection, we cannot commence commercial production of the product. Moreover, we do not currently have a
pollution and remediation insurance policy to mitigate any risk related to environmental pollution or violation of environmental law.
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Failure to commence development of land which we have been granted right to use within the required timeframe may cause us to lose our land use rights.
Sinovac Dalian was granted land use rights to two parcels of land, with an aggregate area of 95,686 square meters (approximately 1,030,000 square feet) located
in the Economic and Technical Development Zone of Dalian, Liaoning province by the local government. According to the relevant PRC regulations, a parcel
of land may be treated as idle land if development of the land has not been commenced within one year after the commencement date stipulated in the land use
rights grant contract or the issuance date of the construction land approval certificate. Land users can extend the deadline for commencing the construction work
for one year. All of our facilities of Sinovac Dalian are located at one of the two parcels of the land with an aggregated area of 55,606 square meters (598,582
square feet). However, as of the date of this annual report, we have not commenced development of the other parcel of the land with 40,080 square meters
(431,418 square feet), which Sinovac Dalian was granted the right to use. PRC government may treat the land as idle land, in which case we may be required to
pay idle land fees or penalties, change the intended use of the land, find another parcel of land, or even be required to forfeit the land to PRC government, any of
which would adversely affect our financial condition.
Negative publicity regarding China-based companies listed in the United States may affect the trading price of our common shares and result in increased
regulatory scrutiny of our business.
In the past, litigation and negative publicity surrounding companies with operations in China that are listed in the United States have resulted in declining stock
prices for such companies. Various equity research organizations have published reports on China-based companies after examining their corporate governance
practices, related party transactions, sales practices and financial statements that have led to special investigations and stock suspensions on national exchanges.
Any similar scrutiny of us, regardless of merit, could result in a diversion of our management’s attention from managing our core business, negative publicity,
potential costs to defend ourselves against rumors, volatility and loss in the trading price of our common shares and increased directors’ and officers’ insurance
premiums, any of which could materially and adversely affect our business, financial condition and results of operations.
Risks Related to Our Intellectual Property
If we are unable to protect our technologies from competitors with patents or other forms of intellectual property protection, our business may be harmed.
Our success depends, in part, on our ability to protect our proprietary technologies. We try to protect the technology that we consider important to our business
by filing PRC patent applications and relying on trade secret and pharmaceutical regulatory protection.
We have a total of 29 issued patents and a number of pending patent applications relating to our vaccines in China, for which our hepatitis A vaccine and
seasonal influenza vaccine have five and three issued patents for protection, respectively. The process of seeking patent protection in China can be lengthy and
expensive and we cannot assure you that our pending patent applications, or any patent applications we may make in the future with respect to other products,
will result in issued patents, or that any patents issued in the future will be able to provide us with meaningful protection or commercial advantage. Our patent
applications may be challenged, invalidated or circumvented in the future.
In addition to patents, we rely on trade secrets and proprietary know-how to protect our intellectual property. We have entered into confidentiality agreements
(which include, in the case of employees, non-competition provisions) with many of our employees, consultants, outside scientific collaborators, sponsored
researchers and other advisors. These agreements provide that all confidential information developed or made known to the individual during the course of the
individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of our employees, the
agreements provide that all of the technology which is conceived by the individual during the course of employment is our exclusive property. These
agreements may not provide meaningful protection or adequate remedies in the event of unauthorized use or disclosure of our proprietary information. In
addition, it is possible that third parties could independently develop information and techniques substantially similar to ours or otherwise gain access to our
trade secrets.
We cannot assure you that our current or potential competitors, many of whom have substantial resources and have made substantial investments in competing
technologies, do not have and will not develop products that compete directly with our products despite our intellectual property rights.
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Intellectual property rights and confidentiality protections in China may not be as effective as in the United States or other countries. Policing unauthorized use
of proprietary technology is difficult and expensive, and we might need to resort to litigation to enforce or defend patents issued to us or to determine the
enforceability, scope and validity of our proprietary rights or those of others. The experience and capabilities of PRC courts in handling intellectual property
litigation varies, and outcomes are unpredictable. Further, such litigation may require significant expenditures of cash and management efforts and could harm
our business, financial condition and results of operations. An adverse determination in any such litigation could materially impair our intellectual property
rights and may harm our business, prospects and reputation.
We may be exposed to infringement or misappropriation claims by third parties which, if determined adversely to us, could cause substantial liabilities to us, or
we may be unable to sell some of our products. Please see “Item 4. Information on the Company — B. Business Overview — Intellectual Property and
Proprietary Technology”.
Third parties may bring intellectual property infringement claims against us in the future.
Our commercial success also depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Even
after reasonable investigation, we may not know with certainty whether we have infringed upon a third party’s patent due to the complexity of patent claims, the
inadequacy of patent clearance search procedures in the PRC and the fact that a third party may have filed a patent application without our knowledge while that
product was under development by us. Patent applications are maintained in secrecy until their publication 18 months after the filing date. The publication of
discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent
applications were filed. China, similar to many other countries, adopts the first-to-file system under which the first party to file a patent application (instead of
the first to invent the subject invention) may be awarded a patent. There may also be technologies licensed to us or acquired by us that are subject to
infringement, misappropriation or other claims by others which could damage our ability to rely on such technologies.
If a third party claims that we infringe upon its proprietary rights, any of the following may occur:
we may become involved in time-consuming and expensive litigation, even if the claim is without merit;
we may become liable for substantial damages for past infringement if a court decides that our technology infringes upon a competitor’s patent;
a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially
reasonable terms, if at all, or which may require us to pay substantial royalties or grant cross licenses to our patents;
we may have to reformulate our product so that it does not infringe upon others’ patent rights, which may not be possible or could be very expensive
and time-consuming; and
we may be subject to injunctions prohibiting the manufacture and sale of our products or the use of our technologies.
If any of these events occurs, our business will suffer and the market price of our common shares could decline.
The success of our business may depend on licensing vaccine components from, and entering into collaboration arrangements with, third parties. We
cannot be certain that our licensing or collaboration efforts will succeed or that we will realize any revenue from them.
The success of our business strategy depends, in part, on our ability to enter into licensing and collaboration arrangements and to effectively manage the
resulting relationships. Our ability to enter into agreements with commercial partners depends in part on our ability to convince them of the value of our
technology and know-how. This may require substantial time and effort on our part. While we anticipate expending substantial funds and management effort,
we cannot assure you that strategic relationships will result or that we will be able to negotiate additional strategic agreements in the future on acceptable terms,
if at all. Furthermore, we may incur significant financial commitments to collaborators in connection with potential licenses and sponsored research agreements.
In addition, we may not be able to control the areas of responsibility undertaken by our strategic partners and may be adversely affected should these partners
prove to be unable to carry a product candidate forward to full commercialization or should they lose interest in dedicating the necessary resources toward
developing any such product quickly.
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Third parties may terminate our licensing and other strategic arrangements if we do not perform as required under these arrangements. Generally, we expect that
agreements for rights to develop technologies will require us to exercise diligence in bringing product candidates to market and may require us to make
milestone and royalty payments that, in some instances, could be substantial. Our failure to exercise the required diligence or make any required milestone or
royalty payments could result in the termination of the relevant license agreement, which could have a material adverse effect on us and our operations. In
addition, these third parties may also breach or terminate their agreements with us or otherwise fail to conduct their activities in connection with our
relationships in a timely manner. If we or our partners terminate or breach any of our licenses or relationships, we may:
lose our rights to develop and market our product candidates;
lose patent and/or trade secret protection for our product candidates;
experience significant delays in the development or commercialization of our product candidates;
not be able to obtain any other licenses on acceptable terms, if at all; and
incur liability for damages.
Licensing arrangements and strategic relationships in our industry can be very complex, particularly with respect to intellectual property rights. Disputes may
arise in the future regarding ownership rights to technology developed by or with other parties. These and other possible disagreements between us and third
parties with respect to our licenses or our strategic relationships could lead to delays in the research, development, manufacture and commercialization of our
product candidates. These disputes could also result in litigation or arbitration, both of which are time-consuming and expensive. These third parties also may
pursue alternative technologies or product candidates either on their own or in strategic relationships with others in direct competition with us.
Any cessation or suspension of our collaborations with scientific advisors and academic institutions may increase our costs in research and development,
lengthen our new vaccines development process and lower our efficiency in new products development.
We work with scientific advisors and academic collaborators who assist us in some of our research and development efforts. Some of our pre-clinical and
research programs are heavily reliant upon such collaborators and we generally benefit considerably from the resources, technology and experience these
collaborations can provide. These scientists are not, however, our employees and may have other commitments that limit their availability to us. If a conflict of
interest arises between their work for us and their work for another entity, we may lose the services of these scientists and institutions. Any cessation or
suspension of our collaborations with scientific advisors and academic institutions may increase our research and development costs, lengthen our new vaccines
development process and lower our efficiency in new products development. In addition, although our scientific advisors and academic collaborators generally
sign agreements not to disclose our confidential information, it is possible that valuable proprietary knowledge may become publicly known which would
compromise our competitive advantage.
We may lose the right to use “科兴” (Kexing) on our vaccine products and/or as part of our trade name.
We currently use “科兴” (Kexing) as part of Sinovac Beijing’s Chinese trade name in the PRC. We also use “科兴” (Kexing) as part of the Chinese trade name
of Sinovac Dalian in the PRC. Shenzhen Kexing currently owns the “科兴” trademark registered in China for Class 5 (Pharmaceuticals) under the International
Classification of Goods and Services. To protect our interest in using “科兴” in our trade name, we applied to register “科兴” in China for Class 42 (Scientific
& Technological Services &Research) in 2006 and the PRC Trademark Office of the State Administration for Industry and Commerce approved our application
in 2010. The “科兴” trademark owned by Shenzhen Kexing has not been identified as “Well-known Trademark” by the relevant PRC authorities since we first
started using “科兴” in the trade name of Sinovac Beijing in 2001. If the “科兴” trademark owned by Shenzhen Kexing is ever officially identified as a “Well-
Known Trademark,” however, we may be subject to trademark infringement claim for the use of “科兴” in our trade name. Although the trademark application
and the trade name approval systems are administered separately in China, it is possible that we may lose our ability to use the “科兴” trademark in our trade
name due to a successful trademark infringement claim, which may adversely affect our ability to maintain and protect our brands, cause us to incur litigation
costs and divert resources and management attention.
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Risks Related to Doing Business in China
Adverse changes in political, economic and other policies of the PRC government could have a material adverse effect on the overall economic growth of
China, which could reduce the demand for our products and materially and adversely affect our competitive position.
All of our business operations are conducted in China, and around 99.1% of our sales are currently made in China. Accordingly, our business, financial
condition, results of operations and prospects are affected significantly by economic, political and legal developments in China. The Chinese economy differs
from the economies of most developed countries in many respects, including:
the extent of government involvement;
the level of development;
the growth rate;
the control of foreign exchange;
the allocation of resources;
an evolving regulatory system; and
a lack of sufficient transparency in the regulatory process.
While the Chinese economy has experienced significant growth in the past 30 years, growth has been uneven, both geographically and among various sectors of
the economy. The PRC government has implemented various measures to encourage economic growth and guide the allocation of resources. Some of these
measures benefit the overall Chinese economy, but may also have a negative effect on us. For example, our financial condition and results of operations may be
adversely affected by government control over capital investments or changes in tax regulations that are applicable to us.
The Chinese economy has been transitioning from a planned economy to a more market-oriented economy. Although in recent years the PRC government has
implemented measures emphasizing the utilization of market forces for economic reform, the reduction of state ownership of productive assets and the
establishment of sound corporate governance in business enterprises, a substantial portion of the productive assets in China is still owned by the Chinese
government. The continued control of these assets and other aspects of the national economy by the PRC government could materially and adversely affect our
business. The PRC government also exercises significant control over Chinese economic growth through the allocation of resources, controlling payment of
foreign currency-denominated obligations, setting monetary policy and providing preferential treatment to particular industries or companies. Efforts by the
PRC government to slow the pace of growth of the Chinese economy could result in hospitals spending less, which in turn could reduce demand for our
products.
Moreover, the political relationship among foreign countries and China is subject to sudden fluctuation and periodic tension. Changes in political conditions in
China and changes in the state of foreign relations are difficult to predict and could adversely affect our product export and international collaborations. This
could lead to a decline in our profitability in the future.
Although the Chinese economy has grown significantly in the past decade, that growth may not continue, as evidenced by the slowing of the growth of the
Chinese economy since 2012. Any adverse change in the economic conditions or government policies in China could have a material adverse effect on overall
economic growth and the level of healthcare investments and expenditures in China, which in turn could lead to a reduction in demand for our products and
consequently have a material adverse effect on our businesses.
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Future changes in laws, regulations or enforcement policies in China could adversely affect our business.
Laws, regulations and enforcement policies in China, including those regulating our business, are evolving and subject to future change. Future changes in laws,
regulations or administrative interpretations, or stricter enforcement policies by the PRC government, could impose more stringent requirements on us,
including fines or other penalties. Changes in applicable laws and regulations may also increase our operating costs. Compliance with such requirements could
impose substantial additional costs or otherwise have a material adverse effect on our business, financial condition and results of operations. These changes may
relax some requirements, which could be beneficial to our competitors or could lower market entry barriers and increase competition. Further, regulatory
agencies in China may, sometimes abruptly, change their enforcement practices. Therefore, prior enforcement activity, or lack of enforcement activity, is not
necessarily predictive of future actions. Any enforcement actions against us could have a material adverse effect on us and the market price of our common
shares. In addition, any litigation or governmental investigation or enforcement proceedings in China may be protracted and may result in substantial cost and
diversion of resources and management attention, negative publicity, damage to our reputation and decline in the price of our common shares.
We rely on dividends paid by our PRC subsidiaries for our cash needs. If they are unable to pay us sufficient dividends due to statutory or contractual
restrictions on their abilities to distribute dividends to us, our various cash needs may not be met.
We are a holding company, and we rely on the dividends paid by our PRC subsidiaries, including majority-owned subsidiary, Sinovac Beijing, our wholly-
owned subsidiaries, and Sinovac R&D (formerly known as Sinovac Biological and our 55%-owned subsidiary, Sinovac Dalian, for our cash needs, including
the funds necessary to pay any dividends and other cash distributions to our shareholders, service any debt we may incur and pay our operating expenses. The
payment of dividends in the PRC is subject to limitations. Regulations in the PRC currently permit payment of dividends by our PRC subsidiaries only out of
accumulated profits as determined in accordance with accounting standards and regulations in China. For instance, in accordance with the regulations in China,
Sinovac Beijing, Sinovac Dalian, Sinovac R&D and Sinovac Biomed are required to set aside at least 10% of its after-tax profits each year to contribute to its
reserve fund until the accumulated balance of such reserve fund reaches 50% of the registered capital of each company. Sinovac Beijing, Sinovac Dalian,
Sinovac R&D and Sinovac Biomed are required to set aside, at the discretion of their respective board of directors, a portion of their annual income after taxes
to their employee welfare and bonus funds. These funds reduce the ability of the subsidiaries to pay dividend in cash. In addition, if Sinovac Beijing, Sinovac
Dalian, Sinovac R&D or Sinovac Biomed incurs debt on its own behalf in the future, the instruments governing the debt may restrict either company’s ability to
pay dividends or make other distributions to us.
Restrictions on currency exchange may limit our ability to receive and use our revenues effectively.
We receive over 99% of our revenues in renminbi, which currently is not a freely convertible currency. A portion of our revenues may be converted into other
currencies to meet our foreign currency obligations, including, among others, payment of dividends declared by our subsidiaries. Under China’s existing foreign
exchange regulations, Sinovac Beijing, Sinovac R&D and Sinovac Dalian are able to pay dividends in foreign currencies without prior approval from the State
Administration of Foreign Exchange, or the SAFE, by complying with certain procedural requirements. However, we cannot assure you that the PRC
government will not take future measures to restrict access to foreign currencies for current account transactions.
Our PRC subsidiaries’ ability to obtain foreign exchange is subject to significant foreign exchange controls and, in the case of amounts under the capital
account, requires the approval of and/or registration with PRC government authorities, including the SAFE. In particular, if we finance our PRC subsidiaries by
means of foreign currency from us or other foreign lenders, the amount is not allowed to exceed the difference between the amount of total investment and the
amount of the registered capital as approved by the Ministry of Commerce and registered with the SAFE. Further, such loans must be registered with the SAFE.
If we finance our PRC subsidiaries by means of additional capital contributions, the amount of these capital contributions must first be approved by the relevant
government approval authority. These limitations could affect the ability of our PRC subsidiaries to obtain foreign exchange through debt or equity financing.
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Fluctuation in the value of the renminbi may have a material adverse effect on your investment.
The value of the renminbi against the U.S. dollar, Euro and other currencies is affected by, among other things, changes in China’s political and economic
conditions and China’s foreign exchange policies. The PRC government allows the renminbi to fluctuate within a narrow and managed band against a basket of
certain foreign currencies. In recent years, the exchange rate between the renminbi and U.S. dollar has been relatively stable and consequently the renminbi has
sometimes fluctuated sharply against other freely traded currencies, in tandem with the U.S. dollar. Since June 2010, the RMB has started to slowly appreciate
against the U.S. dollar, though there have been periods when the U.S. dollar has appreciated against the RMB. On August 11, 2015, the People’s Bank of China
allowed the RMB to depreciate by approximately 2% against the U.S. dollar. Over the following two days, Chinese currency fell 3.5% against the dollar. It is
difficult to predict how long such depreciation of the RMB against the U.S. dollar may last and when and how the relationship between the RMB and the U.S.
dollar may change again. The PRC government indicated that it will make the foreign exchange rate of the renminbi more flexible and widen the trading band of
renminbi, which increases the possibility of sharp fluctuations in renminbi’s value in the future as well as the unpredictability associated with renminbi’s
exchange rate. There remains significant international pressure on the PRC government to adopt an even more flexible currency policy, which could result in
further and more significant fluctuations of the renminbi against foreign currencies. As the majority of our costs and expenses are denominated in renminbi, a
resumption of the appreciation of the renminbi against the U.S. dollar would further increase our costs in U.S. dollar terms. In addition, as our operating
subsidiaries in China receive revenues in renminbi, any significant depreciation of the renminbi against the U.S. dollar may have a material adverse effect on
our revenues in U.S. dollar terms and financial condition, and the value of, and any dividends payable on, our common shares. For example, to the extent that
we need to convert U.S. dollars into renminbi for our operations, appreciation of the renminbi against the U.S. dollar would have an adverse effect on the
renminbi amount we receive from the conversion. Conversely, if we decide to convert our renminbi into U.S. dollars for the purpose of making payments for
dividends on our common shares or for other business purposes, appreciation of the U.S. dollar against the renminbi would have a negative effect on the U.S.
dollar amount available to us.
Our business benefits from certain government tax incentives. Expiration, reduction or elimination of these incentives will increase our tax expenses and in
turn decrease our net income.
Pursuant to the PRC Enterprise Income Tax Law, or the EIT Law, and its implementation rules, both domestic companies and the foreign invested enterprises,
or the FIEs, are subject to a unified income tax rate of 25%. Tax exemption or reduction with fixed terms enjoyed by enterprises including us will continue until
the expiry of the prescribed period. Preferential tax treatments will continue to be granted to high and new technology enterprises that conduct business in
encouraged sectors, whether FIEs or domestic companies. Sinovac Beijing reconfirmed its “High and New Technology Enterprises,” or HNTE, status and
obtained the corresponding certificate in 2014 for a period of three years. As a result, subject to satisfaction of applicable criteria as confirmed by the competent
authorities, Sinovac Beijing was entitled to a reduced enterprise income tax, or EIT, rate of 15% from 2014 to 2016. The PRC government could eliminate any
of these preferential tax treatments before their scheduled expiration. Expiration, reduction or elimination of such tax incentives will increase our tax expenses
and in turn decrease our net income.
Under the EIT Law, dividends payable by us and gains on the disposition of our shares may be subject to PRC taxation.
If we were considered a PRC resident enterprise under the EIT Law, our shareholders who are deemed non-resident enterprises may be subject to the EIT at the
rate of 10% upon the dividends payable by us or upon any gains realized from the transfer of our shares, if such income is deemed derived from China, provided
that (i) such foreign enterprise investor has no establishment or premises in China, or (ii) it has an establishment or premises in China but its income derived
from China has no real connection with such establishment or premises. If we were required under the EIT Law to withhold PRC income tax on our dividends
payable to our non-PRC enterprise shareholders, or if any gains realized from the transfer of our shares by our non-PRC enterprise shareholders were subject to
the EIT, such shareholders’ investment in our shares would be materially and adversely affected.
27
PRC regulations relating to investments in offshore companies by PRC residents may subject our PRC-resident beneficial owners or our PRC subsidiaries
to liability or penalties, limit our ability to inject capital into our PRC subsidiaries or limit our PRC subsidiaries’ ability to increase their registered capital
or distribute profits.
SAFE promulgated the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and
Roundtrip Investment through Special Purpose Vehicles, or SAFE Circular 37, on July 4, 2014, which replaced the former circular commonly known as “SAFE
Circular 75” promulgated by SAFE on October 21, 2005. SAFE Circular 37 requires PRC residents to register with the local branches of SAFE in connection
with their direct establishment or indirect control of an offshore entity, for the purpose of overseas investment and financing, with such PRC residents’ legally
owned assets or equity interests in domestic enterprises or offshore assets or interests, referred to in SAFE Circular 37 as a “special purpose vehicle.” SAFE
Circular 37 further requires amendment to the registration in the event of any significant changes with respect to the special purpose vehicle, such as increase or
decrease of capital contributed by PRC individuals, share transfer or exchange, merger, division, or other material events. In the event that a PRC shareholder
holding interests in a special purpose vehicle fails to fulfill the required SAFE registration, the PRC subsidiaries of that special purpose vehicle may be
prohibited from making profit distributions to the offshore parent and from carrying out subsequent cross-border foreign exchange activities, and the special
purpose vehicle may be restricted in its ability to contribute additional capital into its PRC subsidiary. Moreover, failure to comply with the various SAFE
registration requirements described above could result in liability under PRC law for evasion of foreign exchange controls. According to the Notice on Further
Simplifying and Improving Policies for the Foreign Exchange Administration of Direct Investment released on February 13, 2015 by SAFE, local banks will
examine and handle foreign exchange registration for overseas direct investment, including the initial foreign exchange registration and amendment registration,
under SAFE Circular 37 from June 1, 2015. However, since this notice has not yet come into force, there exist high uncertainties with respect to its
interpretation and implementation by governmental authorities and banks.
Mr. Weidong Yin has made the required SAFE registration with respect to his investments in our company. However, we may not be aware of the identities of
all of our beneficial owners who are PRC residents. We do not have control over our beneficial owners and cannot assure you that all of our PRC-resident
beneficial owners will comply with SAFE Circular 37 and subsequent implementation rules. The failure of our beneficial owners who are PRC residents to
register or amend their foreign exchange registrations in a timely manner pursuant to SAFE Circular 37 and subsequent implementation rules, or the failure of
future beneficial owners of our company who are PRC residents to comply with the registration procedures set forth in SAFE Circular 37 and subsequent
implementation rules, may subject such beneficial owners or our PRC subsidiaries to fines and legal sanctions. Furthermore, since SAFE Circular 37 was
recently promulgated and it is unclear how this regulation, and any future regulation concerning offshore or cross-border transactions, will be interpreted,
amended and implemented by the relevant PRC government authorities, we cannot predict how these regulations will affect our business operations or future
strategy. Failure to register or comply with relevant requirements may also limit our ability to contribute additional capital to our PRC subsidiaries and limit our
PRC subsidiaries’ ability to distribute dividends to our company. These risks may have a material adverse effect on our business, financial condition and results
of operations.
Any failure to comply with PRC regulations regarding our employee equity incentive plans may subject the PRC plan participants or us to fines and other
legal or administrative sanctions.
Pursuant to SAFE Circular 37, PRC residents who participate in share incentive plans in overseas non-publicly-listed companies due to their position as
director, senior management or employees of the PRC subsidiaries of the overseas companies may submit applications to SAFE or its local branches for the
foreign exchange registration with respect to offshore special purpose companies. Our directors, executive officers and other employees who are PRC residents
and who have been granted options and restricted shares were able to follow SAFE Circular 37 to apply for the foreign exchange registration before our
company became an overseas listed company. Since our company has become an overseas listed company, we and our directors, executive officers and other
employees who are PRC residents and who have been granted options are subject to the Notice on Issues Concerning the Foreign Exchange Administration for
Domestic Individuals Participating in Stock Incentive Plan of Overseas Publicly Listed Company, issued by SAFE in February 2012, according to which,
employees, directors, supervisors and other management members participating in any stock incentive plan of an overseas publicly listed company who are PRC
residents are required to register with SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and
complete certain other procedures. Failure to complete the SAFE registrations may subject them to fines and legal sanctions and may also limit the ability to
make payment under our equity incentive plans or receive dividends or sales proceeds related thereto, or our ability to contribute additional capital into our
wholly-foreign owned enterprises in China and limit our wholly-foreign owned enterprises’ ability to distribute dividends to us. We also face regulatory
uncertainties that could restrict our ability to adopt additional equity incentive plans for our directors and employees under PRC law.
In addition, the State Administration for Taxation has issued circulars concerning employee share options or restricted shares. Under these circulars, employees
working in the PRC who exercise share options, or whose restricted shares or restricted share units, or RSUs, vest, will be subject to PRC individual income tax.
The PRC subsidiaries of an overseas listed company have obligations to file documents related to employee share options or restricted shares with relevant tax
authorities and to withhold individual income taxes of those employees related to their share options, restricted shares or RSUs. If the employees fail to pay, or
the PRC subsidiaries fail to withhold, their income taxes according to relevant laws, rules and regulations, the PRC subsidiaries may face sanctions imposed by
the tax authorities or other PRC government authorities.
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PRC regulation of loans and direct investment by offshore holding companies to PRC entities may delay or prevent us from making loans or additional
capital contributions to our PRC operating subsidiaries and affiliated entities.
In funding our PRC subsidiaries, we must comply with PRC legal requirements relating to foreign debt registration and to PRC foreign-investment companies’
“registered capital” and “total investment.” “Registered capital” refers to the capital contributed to or paid into a PRC foreign-investment company in cash or in
kind, and “total investment” refers to the amount of a PRC foreign-investment company’s registered capital plus all external borrowings by such company. The
amounts of a PRC foreign-investment company’s registered capital and total investment are set forth in the company’s constitutional documents and approved
by the competent government authority in advance and, in the case of Sinovac Beijing and Sinovac Dalian, must be approved by their minority shareholders,
Sinobioway Medicine (formerly named Xiamen Bioway Group Co., Ltd) or Dalian Jin Gang Group, respectively, as well.
Loans by us or Sinovac Hong Kong to Sinovac Beijing, Sinovac R&D or Sinovac Dalian cannot exceed the difference between such company’s registered
capital and total investment, unless the company has obtained the approval of the approval authority and, in the case of Sinovac Beijing or Sinovac Dalian, the
approval of Sinobioway Medicine or Dalian Jin Gang Group, respectively, to increase the amount of total investment. Further, such loans must be registered
with the SAFE or its local counterpart.
We may also decide to finance our PRC subsidiaries by making additional capital contributions. These additional contributions must be approved by the
government approval authority and, in the case of Sinovac Beijing or Sinovac Dalian, by Sinobioway Medicine or Dalian Jin Gang Group, respectively. We
cannot assure you that we will be able to obtain these government registrations or approvals, or the approval of Sinobioway Medicine or Dalian Jin Gang Group,
on a timely basis, if at all, with respect to future loans or additional capital contributions by us to our subsidiaries or affiliates. If we fail to obtain such
registrations or approvals, our ability to capitalize our PRC operations would be negatively affected, which could adversely and materially affect the liquidity of
our subsidiaries and our ability to expand our business.
Because we are incorporated under Antigua and Barbuda law, substantially all of our operations, property and assets are located in China and all of our
directors and officers and substantially all of their assets are located outside of the United States, you may be unable to protect your shareholder rights
under U.S. law in a court in the United States.
We are incorporated in Antigua and Barbuda. Our corporate affairs are governed by our Articles of Incorporation and By-laws and by the International Business
Corporations Act and common law of Antigua and Barbuda. The rights of shareholders to take legal action against our directors, officers and us, actions by
minority shareholders and the fiduciary responsibilities of our directors to us are to a large extent governed by the International Business Corporations Act and
common law of Antigua and Barbuda. The common law of Antigua and Barbuda is derived in part from comparatively limited judicial precedent in Antigua and
Barbuda as well as from English common law, which has persuasive, but not binding, authority on a court in Antigua and Barbuda. The rights of our
shareholders and the fiduciary responsibilities of our directors under Antigua and Barbuda law are not as clearly established as they would be under statutes or
judicial precedents in the United States. Among other things, Antigua and Barbuda has a less developed body of securities laws as compared to the United
States, and provides significantly less protection to investors. Further, Antigua and Barbuda’s body of securities law, and the experience of its courts in
addressing corporate and securities law issues of a type often experienced by public companies, is likely less developed than that of some of the other
jurisdictions where publicly traded China-based companies are incorporated, such as the Cayman Islands.
It may be difficult or impossible for you to bring an action against us or our directors or officers in Antigua and Barbuda or to enforce or protect your rights
under U.S. securities laws or otherwise. Even if you are successful in bringing an action of this kind, you may be unable to enforce a judgment against our assets
or the assets of our directors and officers under the laws of Antigua and Barbuda.
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There is doubt as to whether Antigua and Barbuda courts would enforce judgments of United States courts obtained in actions against us or our directors or
officers that are predicated upon the civil liability provisions of the Securities Act, or in original actions brought against us or such persons predicated upon the
Securities Act. There is no treaty in effect between the United States and Antigua and Barbuda providing for such enforcement, and there are grounds upon
which Antigua and Barbuda courts may not enforce judgments of United States courts. In addition, Antigua and Barbuda corporations may not have standing to
initiate a shareholder derivative action before the federal courts of the United States.
PRC courts may recognize and enforce foreign judgments in accordance with the requirements of the PRC Civil Procedures Law based either on treaties
between the PRC and the country where the judgment is made or on reciprocity between jurisdictions. If there are no treaties or reciprocity arrangements
between the PRC and a foreign jurisdiction where a judgment is rendered, matters relating to the recognition and enforcement of the foreign judgment in the
PRC may be resolved through diplomatic channels. The PRC does not have any treaties or other arrangements with the United States or Antigua and Barbuda
that provide for the reciprocal recognition and enforcement of foreign judgments. As a result, it is generally difficult to enforce in the PRC a judgment rendered
by a U.S. or Antigua and Barbuda court.
As a result of all of the above, as well as the fact that substantially all of our property, assets and operations are located in China and all of our directors and
officers and substantially all of their assets are located outside of the United States, you may be unable to protect your shareholder interests through actions
against us or our management, directors or major shareholders.
We may be adversely affected by the final outcome of the administrative proceedings brought by the SEC against Ernst & Young Hua Ming LLP and other
accounting firms in China.
In December 2012, the SEC initiated administrative proceedings against the China affiliates of five accounting firms, including our independent registered
public accounting firm, Ernst & Young Hua Ming LLP, alleging that they refused to produce audit work papers and other documents related to certain China-
based companies under investigation by the SEC for potential accounting fraud, and thus violated U.S. securities laws and SEC rules and regulations. On
January 22, 2014, an SEC administrative law judge ruled in favor of the SEC, issuing an initial decision which censured each of the accounting firms for failure
to provide their audit work papers to the SEC and ordered a six-month suspension of Ernst & Young Hua Ming LLP’s and the other China-based affiliates of the
Big Four accounting firms’ right to practice before the SEC. On February 12, 2014, four of these China-based accounting firms appealed to the SEC against this
decision. In February 2015, each of the four China-based accounting firms agreed to a censure and to pay a fine to the SEC to settle the dispute and avoid
suspension of their ability to practice before the SEC. The firms’ ability to continue to serve all their respective clients is not affected by the settlement. The
settlement stays the current proceeding for four years, during which time the firms are required to follow detailed procedures to seek to provide the SEC with
access to Chinese firms’ audit documents via China Securities Regulatory Commission. If a firm does not follow the procedures, the SEC could impose
penalties such as suspensions, or it could restart the administrative proceedings or commence a new, expedited administrative proceeding against the non-
compliant firm. The settlement did not require the firms to admit to any violation of law and preserves the firms’ legal defenses in the event the administrative
proceeding is restarted.
In the event that the SEC restarts the administrative proceedings, depending upon the final outcome, listed companies in the United States with major PRC
operations may find it difficult or impossible to retain auditors in respect of their operations in the PRC, which could result in financial statements being
determined to not be in compliance with the requirements of the Exchange Act, including possible delisting. Moreover, any negative news about the
proceedings against these audit firms may cause investor uncertainty regarding China-based, United States-listed companies and the market price of our
common shares may be adversely affected.
If, as a result of this or any other action, the SEC suspends the right of Ernst & Young Hua Ming LLP to practice before the SEC, our ability to file financial
statements in compliance with SEC requirements could be impacted. If none of the China-based auditors are able to continue to act as auditors for Chinese
companies listed in the U.S., we may not be able to meet the reporting requirements under the Exchange Act, which may ultimately result in our deregistration
by the SEC and delisting from the NASDAQ Stock Market, which would substantially reduce or effectively terminate the trading of our common shares in the
United States. Moreover, any negative news about the proceedings against these audit firms may erode investor confidence in China-based, United States listed
companies and the market price of our common shares may be adversely affected.
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We and our investors may be adversely affected by the inability of the Public Company Accounting Oversight Board, or the PCAOB, to carry out inspections
of Ernst & Young Hua Ming LLP and other accounting firms in China.
Under the Sarbanes Oxley Act, auditors of companies whose shares are publicly traded in the United States, including our independent registered public
accounting firm, Ernst & Young Hua Ming LLP, are required to register with the PCAOB and to undergo regular inspections by the PCAOB to assess
compliance with applicable U.S. legal and accounting professional standards. As the PCAOB is currently unable to conduct inspections in China, Ernst &
Young Hua Ming LLP has not yet been inspected by the PCAOB. PCAOB inspections of other audit firms in other jurisdictions have identified deficiencies in
the audit and quality control procedures of those firms, which may be addressed to improve future audit quality. The inability of the PCAOB to conduct
inspections of independent registered public accounting firms operating in China makes it more difficult to evaluate the effectiveness of our auditor’s audit or
quality control procedures. As a result, investors in our common shares may have less confidence in our publicly reported financial information and procedures
and the quality of our financial statements. In addition, the PCAOB may choose to impose sanctions or take other actions against Ernst & Young Hua Ming
LLP, including suspending or revoking Ernst & Young Hua Ming LLP’s registration with the PCAOB. If Ernst & Young Hua Ming LLP and other China-based
auditors are unable to maintain registration with the PCAOB, we may be unable to meet the ongoing reporting requirements under the Exchange Act, which
ultimately may result in the termination of the registration of our common shares and ordinary shares under the Exchange Act or the delisting of our common
shares from NASDAQ, or both, which would substantially reduce or effectively terminate the trading of our common shares in the United States.
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
Our legal and commercial name is Sinovac Biotech Ltd. Our principal executive offices are located at No. 39, Shangdi Xi Road, Haidian District, Beijing
100085, PRC. Our telephone number at this address is +86-10-8289-0088. Our registered address is located at The Colony House, 41 Nevis Street, St. John’s in
Antigua and Barbuda. Our agent for service of process in the United States is Law Debenture Corporate Services Inc., located at 400 Madison Avenue, 4th
Floor, New York.
We are a holding company and conduct our business in China through our 73.09% majority-owned subsidiary Sinovac Beijing, our wholly owned subsidiary
Sinovac R&D, 55%-owned joint venture Sinovac Dalian, our wholly owned subsidiary Sinovac Biomed and Sinovac Hong Kong. Sinovac Beijing was
incorporated on April 28, 2001, Sinovac R&D was incorporated on May 7, 2009, Sinovac Dalian was established on January 19, 2010, Sinovac Biomed was
incorporated on April 16, 2015 and Sinovac Hong Kong was incorporated on October 21, 2008.
We were incorporated in Antigua and Barbuda on March 1, 1999 as an Antiguan company with limited liability under the laws of Antigua and Barbuda. Before
we adopted our current name on October 21, 2003, we were called Net-Force System Inc. and were primarily engaged in the online gaming business. We were
quoted on the OTC Bulletin Board on February 21, 2003. In September 2003, we issued ten million new shares to Lily Wang, one of our then principal
shareholders to acquire a 51% equity interest in Sinovac Beijing. Ms. Wang had contracted to purchase these shares from certain of Sinovac Beijing’s then
shareholders for cash immediately before the above 51% share transfer. However, this 51% equity interest in Sinovac Beijing was transferred to us directly from
those shareholders and was recorded under applicable PRC law transfer documents as a cash transaction. Lily Wang was responsible for paying the cash to
those shareholders. The transfer of the Sinovac Beijing equity interest to us was registered and approved by PRC government authorities in August 2004. In
September 2004, we acquired an additional 20.6% equity interest in Sinovac Beijing for approximately $3.3 million in cash. In October 2011, we further
acquired an additional 1.53% equity interest in Sinovac Beijing through contributing the dividends declared to Sinovac Hong Kong but unpaid in amount of
RMB18.6 million ($2.9 million). We currently own 73.09% of the equity interest in Sinovac Beijing.
In January 2004, we entered into a share purchase agreement with Heping Wang and issued him 3.5 million of our common shares and a promissory note in the
amount of $2.2 million to acquire from him a 100% equity interest in Tangshan Yian. Mr. Wang had contracted to purchase these shares from Tangshan Yian’s
then two shareholders immediately before the above 100% share transfer. However, this 100% equity interest in Tangshan Yian was transferred to us directly
from those shareholders and was recorded under applicable PRC law transfer documents as a cash transaction. Heping Wang was responsible for paying the
cash to the two shareholders. The transfer of the Tangshan Yian equity interest by Mr. Wang to us was registered and approved by PRC government authorities
in November 2004.
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In the first quarter of 2008, we issued and sold an aggregate of 2.5 million common shares at $3.90 per share to Sansar Capital Management. We received
approximately $9.75 million in gross proceeds from this private placement of our common shares.
In October 2008, we established Sinovac Hong Kong, a wholly owned subsidiary focused primarily on registering and distributing current and newly-developed
vaccine products in Hong Kong and exporting our products abroad. In addition, Sinovac Hong Kong seeks research and development collaboration
opportunities with third parties in Hong Kong.
In November 2009, we entered into an agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, we established Sinovac Dalian
which focuses on the research, development, manufacturing and commercialization of live attenuated vaccines, such as varicella and mumps vaccines for human
use. Pursuant to the joint venture agreement, we made an initial cash contribution of RMB60.0 million ($9.3 million) in exchange for a 30% equity interest in
Sinovac Dalian and Dalian Jin Gang Group made an asset contribution of RMB140.0 million ($21.6 million), including manufacturing facilities, production
lines and land use rights, in exchange for the remaining 70% interest in Sinovac Dalian. In December 2010, we purchased an additional 25% equity interest in
Sinovac Dalian from Dalian Jin Gang Group with a consideration of RMB50.0 million ($7.7 million). We and Dalian Jin Gang Group currently own 55% and
45% equity interests in Sinovac Dalian, respectively.
In February 2010, we closed a public offering of our common shares. We issued and sold 11.5 million common shares at the price of $5.75 per share. We
received net proceeds of approximately $61.8 million, after deducting underwriting discounts and commissions and offering expenses payable by us.
In February 2010, we entered into an agreement to acquire buildings, land use rights and utility facilities in Changping District, Beijing for a total consideration
of approximately RMB123.6 million ($19.1 million). We have paid off the consideration. We have completed the construction of a new warehouse, a new
filling and packaging line and a production line for EV71 vaccine in compliance with the new GMP standards.
In 2013, we increased the capital investment to Tangshan Yian with the total amount of $4 million that was borrowed by Tangshan from us in 2010. In the same
year, we lent Tangshan Yian $1 million to be used for sales and marketing spending and other corporate purposes operational activities. In 2014, the board of
directors passed a resolution to increase capital contribution to Sinovac Dalian in the amount of RMB80.0 million ($12.3 million), which will increase Sinovac’s
equity ownership from 55% to 68%. RMB50.0 million ($7.7 million) was provided through foreign debt first with the expectation of a debt to equity swap of
the total amount after the remaining RMB30.0 million ($4.6 million) is provided to Sinovac Dalian.
In April 2015, Sinovac established Sinovac Biomed Co., Ltd., which is 100% owned by Sinovac Biotech (Hong Kong) Ltd. Sinovac Biomed Co., Ltd. focuses
on the distribution of vaccine products as well as providing consulting services in the vaccination industry.
In December 2015, Sinovac entered into an equity interest transfer agreement with Beijing Kuai Le Xing Biotech Co., Ltd. to transfer Sinovac’s 100% equity
interest in Tangshan Yian Biological Engineering Co., Ltd. to Beijing Kuai Le Xing Biotech Co., Ltd. for a consideration of RMB13.0 million ($2.0 million).
As of the date of this annual report, we have received RMB11.0 million ($1.7 million) and will receive the remaining RMB2.0 million ($0.3 million) within two
years of the contract signing date. As a result, Tangshan Yian’s operating results and cash flows are presented as discontinued operations in Sinovac’s financial
results, and Tangshan Yian’s assets and liabilities are presented as held for sale in Sinovac’s financial results.
On January 30, 2016, Sinovac received a preliminary non-binding proposal letter from Mr. Weidong Yin, our chairman, president and chief executive officer,
SAIF Partners IV L.P. and/or its affiliates, to acquire all of our outstanding common shares not owned by them or their affiliates for $6.18 in cash per common
share. The Board has formed a special committee consisting of three independent directors, Mr. Simon Anderson, Mr. Yuk Lam Lo and Mr. Meng Mei, to
consider the proposal. On February 4, 2016, the special committee received a competing non-binding proposal letter, dated February 3, 2016, from a consortium
comprised of PKU V-Ming (Shanghai) Investment Holdings Co., Ltd., Shandong Sinobioway Biomedicine Co., Ltd., CICC Qianhai Development (Shenzhen)
Fund Management Co., Ltd., Beijing Sinobioway Group Co., Ltd., Heng Feng Investments (International) Limited and Fuerde Global Investment Limited, to
acquire all of our outstanding common shares for $7.00 in cash per common share. On April 13, the special committee engaged Duff & Phelps (Duff & Phelps,
LLC and Duff & Phelps Securities, LLC) as its financial advisor to assist it in this process. The special committee has also appointed Weil, Gotshal & Manges
as its U.S. legal counsel, and Leslie-Ann Brissett Legal Services as its Antigua counsel. The special committee will carefully consider and evaluate both
proposals and other alternative proposals with the assistance of the special committee’s independent advisors appointed.
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In March 2016, we adopted the Rights Plan. Pursuant to the Rights Plan, subject to limited exceptions, upon (i) a person or group obtaining ownership of 15%
or more of our common shares or (ii) the commencement or announcement of an intention to make a tender offer or exchange offer, the consummation of which
would result in the beneficial ownership by a person or group of 15% or more of our common shares, in each case, without the approval of our board of
directors, each Right will entitle the holders, other than the Acquiring Person, to buy, at an exercise price of $30.00, one one-thousandth of a share of our newly
created series A junior participating preferred shares, or the Series A Preferred Shares. Holders are entitled to receive, in lieu of each one one-thousandths of a
Series A Preferred Share, common shares having a market value at that time of twice the Right’s exercise price. Our board of directors is entitled to redeem the
Rights at $0.001 per Right at any time before the Rights are exercisable. We refer to the person who acquired 15% or more of the outstanding common shares of
the Company as the “Acquiring Person.”
For additional information regarding our principal capital expenditures, see “— D. Property, Plants and Equipment.”
Investor inquiries should be directed to us at the address and telephone number of our principal executive offices set forth above. Our website is
http://www.sinovac.com. The information contained on our website does not form part of this annual report.
B. Business Overview
We are a fully integrated China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines
that protect against human infectious diseases including hepatitis A, hepatitis B, seasonal influenza, H5N1 and H1N1 pandemic influenza and mumps. In 2002,
we launched our first product, Healive, which was the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. In
2005, we received regulatory approvals for the production of Bilive in China, a combined hepatitis A and B vaccine, and Anflu, a split viron influenza vaccine.
In April 2008, we received regulatory approval for the production in China of our whole viron H5N1 pandemic influenza (avian flu) vaccine, which is the only
vaccine approved for sale to the Chinese national vaccine stockpiling program. In September 2009, we were granted a production license for Panflu.1, which
was the first approved vaccine in the world against the influenza A H1N1 virus (swine flu). In December 2011, Sinovac Dalian obtained the production license
from the CFDA for its mumps vaccine product and launched the mumps vaccine in late 2012. Our pipeline consists of various vaccine candidates in the pre-
clinical and clinical development phases in China. In December 2015, CFDA issued the new drug certificate and production license for our EV71 vaccine, and
in January 2016, CFDA issued the GMP certificate for our EV71 vaccine. We also obtained the approvals to conduct clinical trials of pneumococcal
polysaccharide vaccine, pneumococcal conjugate vaccine, rubella vaccine, varicella vaccine and sIPV, in May 2014, January 2015, December 2014, October
2015 and November 2015, respectively.
Our Products
We specialize in the sales, marketing, manufacturing, and development of vaccines for infectious diseases with significant unmet medical need. Set forth below
is a chart that outlines our current marketed products and those that we have developed or are developing.
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Pre-
clinical
File
IND
Obtain Clinical
Approval from
CFDA
Phase I Phase II
Phase III
On sale
(1)
(2)
(3)
Product
Healive
Bilive
Anflu
Indication
Hepatitis A
Hepatitis A&B
Influenza
Panflu Whole Viron Pandemic Influenza
Pandemic Influenza
Vaccine
Virus
Split Viron Pandemic Influenza Vaccine Pandemic Influenza
Panflu.1
Mumps Vaccine
EV71 Vaccine
Virus
Influenza A H1N1 virus
Mumps
EV71 Virus
Pneumococcal Polysaccharide Vaccine
Pneumococcus
Pneumococcal Conjugate Vaccine
Pneumococcus
Rubella Vaccine
Varicella Vaccine
Rubella
Varicella-zoster virus
(Herpes virus 3, Human)
Sabin Inactivated Polio Vaccine
Polio
Hep B Vaccines
Hep A&B Vaccine(4)
Hepatitis B
Hepatitis A&B
(1) Our Panflu whole viron pandemic influenza vaccine did not undergo phase III clinical trials because none were required by the relevant authorities in order
to receive regulatory approval.
(2) Our Panflu split viron Pandemic Influenza Vaccine did not undergo phase III clinical trials because none were required by the relevant authorities in order
to receive regulatory approval.
(3) Our mumps vaccine did not undergo clinical trials because none were required by the relevant authorities.
(4) The new generation of hepatitis A&B combined vaccine is made from our proprietary hepatitis B vaccine with higher dosage component of 10µg (pediatric
dosage) and 20µg (adult dosage).
Healive. In May 2002, we obtained the final PRC regulatory approval for the production of Healive, the first inactivated hepatitis A vaccine developed
in China. The hepatitis A virus, which is endemic in China and other developing countries, primarily impacts the liver by causing it to swell and
preventing it from functioning properly. The disease is highly contagious and can be spread by close personal contact, by consuming contaminated
food or by drinking water that has been contaminated by hepatitis A. According to the WHO, as no specific treatment exists for hepatitis A, prevention
is the most effective approach against the disease. In February 2008, the PRC government included hepatitis A vaccine into its national immunization
program, and announced plans to expand vaccination to newborns nationwide by the end of 2010. According to the NIFDC lot release records, 26.4
million doses of hepatitis A vaccines were approved and released in China for the year ended December 31, 2015. Administered intramuscularly,
Healive is available in different doses for use by both adults (1.0 ml per dose) and children (0.5 ml per dose). Our production line to manufacture our
hepatitis vaccines, Healive and Bilive, interchangeably has an aggregate combined production capacity of approximately 10 million doses annually. In
2015, 2014 and 2013, we sold approximately 4.1 million, 3.9 million and 4.1 million doses of Healive, which generated approximately $26.8 million,
$26.5 million and $26.4 million in revenues, respectively. Since we launched Healive in 2002, we have sold a total of approximately 49.6 million doses
as of December 31, 2015. We are selling Healive in Mongolia, Nepal and Chile.
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Bilive. In June 2005, we obtained the final PRC regulatory approval for the production of Bilive, the first combined inactivated hepatitis A and B
vaccine developed and marketed in China. Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, which we
manufacture, and recombinant (yeast) hepatitis B surface antigen, which we source from a third-party supplier. Bilive vaccinations must be privately
paid by the recipients under China’s current vaccination program. Bilive is designed for boost immunization or for users in the private-pay market who
prefer the convenience of one inoculation rather than two. Similar to hepatitis A, hepatitis B is endemic in China, a major disease worldwide and a
serious global public health issue. A substantial percentage of people infected with the hepatitis B virus carry chronic or lifelong infections. The
chronically infected are at a high risk of death from cirrhosis of the liver or liver cancer. Currently, we are the only supplier in China that produce a
combined inactivated hepatitis A and B vaccine, and our market share in China, according to the NIFDC lot release records, is 100% in 2014. Bilive is
available in different doses for use in both adults and children. The 1.0 ml dose is for non-immune adults and adolescents 16 years of age and older.
The 0.5 ml dose is for pediatric use in non-immune infants, children and adolescents from one year up to and including 15 years of age. The standard
Bilive vaccination schedule consists of three doses. The second dose is administered one month after the first dose and the third dose is administered
six months after the first dose. Booster vaccinations are recommended five years after the initial immunization. Our production line to manufacture our
hepatitis vaccines, Healive and Bilive, interchangeably has an aggregate combined production capacity of approximately 10 million doses annually. In
2015, 2014 and 2013, we sold approximately 2.3 million, 2.6 million and 2.5 million doses of Bilive, which generated approximately $22.6 million,
$21.9 million and $20.8 million in revenues, respectively.
Anflu. In October 2005, we received the final approval from the CFDA to produce our Anflu vaccine against influenza. We began marketing Anflu in
September 2006. The primary influenza vaccine used worldwide is the split viron vaccine, which contains virus particles disrupted by detergent
treatment. The market penetration of the seasonal flu vaccine in China is significantly below that in the developed markets. We are the first Influenza
Vaccine Supply, or IVS, taskforce member from a developing country that collaborates with world-class partners in influenza vaccine research. Our
Anflu vaccine is an inactivated split viron influenza vaccine formulated from three split inactivated viron solutions. Anflu is produced with the virus
strains recommended by the WHO each year and, we believe, is the only flu vaccine, among all produced by other domestic manufacturers that do not
contain preservatives. According to the NIFDC lot release records, 34.4 million doses of influenza vaccines were approved and released in China for
the year ended December 31, 2015. Our production line to manufacture our flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual
production capacity of approximately 8 million doses of Anflu. We sold 3.2 million, 3.4 million and 3.4 million doses of Anflu in 2015, 2014 and
2013, which generated approximately $12.7 million $12.1 million and $12.2 million in revenues, respectively. Our Anflu products were sold in
Mexico, Guatemala, Mongolia, Philippines, Tajikistan, and Bangladesh.
Panflu. In April 2008, we were granted a production license for Panflu by the CFDA. Panflu is the first and only approved vaccine available in China
against the H5N1 influenza virus. The vaccine is approved for supply within China to the Chinese national vaccine stockpiling program and may not be
sold directly to the Chinese commercial market. Panflu is also registered for sale in the Hong Kong market. Our production line to manufacture our flu
vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of approximately 20 million doses of Panflu or 20 million
doses of Panflu.1 given the yield of virus strain received from WHO. We produced Panflu for government reservation since 2008, and we started
recognizing revenue in 2010. Our revenue from the sale of Panflu amounted to $3.9 million, $0.2 million and $10.7 million in 2015, 2014, and 2013,
respectively.
Panflu.1. In September 2009, we were granted a production license for Panflu.1 by the CFDA. Panflu.1 is the first approved vaccine in the world
against the influenza A H1N1 virus. The outbreaks of influenza A H1N1 was caused by a new virus that had not been seen previously in either human
beings or animals. According to the NIFDC lot release records, we were ranked number two in market share in China in 2009 and number three in
2010. Our production line to manufacture our flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of
approximately 20 million doses of Panflu or 20 million doses of Panflu.1. We started to sell Panflu.1 in September 2009. Our revenue from Panflu.1
amounted to approximately $14 million in 2011, and Panflu.1 is not likely to generate revenues in the foreseeable future. Panflu.1 is also registered for
sale in Mexico.
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Mumps vaccine. Mumps is a viral disease of the human species caused by mumps virus, which poses a significant threat to human health in the
developing countries. According to the NIFDC release records, 5.3 million doses of mumps vaccines were approved and released for the year ended
December 31, 2015. In September 2012, we were granted a production license for mumps vaccine. We began to sell mumps vaccine in December of
2012 and no revenues were recognized in 2012. We sold approximately 1.2 million doses, 1.7 million doses and 1.2 million doses of mumps vaccine in
2015, 2014 and 2013, respectively, which generated approximately $1.5 million, $2.2 million and $1.7 million in revenues in 2015, 2014 and 2013,
respectively.
Split viron pandemic influenza vaccine. Our split viron pandemic influenza vaccine has been developed in conjunction with our whole viron pandemic
influenza vaccine. Split viron vaccines are considered to have a better safety profile than whole viron vaccines, both of which are for the governmental
stockpiling program. This product has been developed to address the needs of young children, who may be more susceptible to adverse reactions to
whole viron pandemic influenza vaccine than to a split viron vaccine. In November 2011, we were granted the production license of split viron
pandemic influenza vaccine that is to be used among the teenagers aged from 12 to 17.
EV71 vaccine. EV71 causes HFMD among children under ten years old. HFMD is a common and usually mild childhood disease; however, HFMD
caused by EV71 has shown a higher incidence of neurologic involvement, and a higher acute fatal incidence. There have been a number of outbreaks of
HFMD caused by EV71 in the Asia-Pacific region since 1997 including in China, Malaysia, Singapore, Australia, Vietnam and Taiwan. According to
the statistics from National Health and Family Planning Commission of China, from 2008 to 2015, more than 13 million cases of HFMD were
reported, resulting in around 3,337 reported fatalities in China. According to an epidemiological study, from 2008 to 2012, EV71 infection caused
around 80% of the severe cases and over 90% of the fatal cases and China CDC’s data for the first months of 2014 further proved the result above.
There is no identified treatment for enterovirus infections. We started our research and development of the EV71 vaccine in 2008. In December 2009,
the CFDA accepted our application to commence human clinical trials and on December 23, 2010, we obtained the approval from the CFDA to
commence clinical trials. In 2013, we completed all three phases of clinical trials, which showed our EV71 vaccine candidate has good safety and
immunogenicity profile, and has an efficacy rate of 94.8% against HFMD among infants and young children. In February 2014, the phase III clinical
trial results of our EV71 vaccine were published online on NEJM, which showed the efficacy of the vaccine against HFMD, or herpangina, was 94.8%
among infants and young children. On December 30, 2015, the CFDA issued the new drug certificate and production license for our EV71 vaccine. On
January 25, 2016, the CFDA issued the GMP certificate for our EV71 vaccine. We have seven granted patents relating to the EV71 vaccine in China.
Our EV71 vaccine primarily targets children from six months old to three years old, with each child requiring a total of two doses one month apart
from another.
Our pipeline consists of vaccine candidates in the clinical and pre-clinical development phases in China, which is listed hereunder.
Pneumococcal polysaccharide vaccine. Pneumococcal polysaccharide vaccine, or PPV, is a vaccine used to prevent streptococcus pneumoniae
(pneumococcus) infections, such as pneumonia and septicemia among adults aged 65 or older, adults with serious long-term health problems, smokers,
and children older than two years with serious long-term health problems. We filed an application for clinical trials to the CFDA in February 2011 and
obtained the approval to commence clinical trials in May 2014. Currently, the phase III clinical trial is underway and is expected to be completed in the
first half of 2017.
36
Pneumococcal conjugate vaccine. Pneumococcal infection is a leading cause of serious illness in children and adults throughout the world. The disease
is caused by a common bacterium, the pneumococcus, which can attack different parts of the human body. According to the WHO, pneumococcal
disease is the leading vaccine-preventable killer of children under five years old in the world. At least one million children die of pneumococcal disease
every year, most of whom are young children in developing countries. Since the U.S. commenced vaccination programs against this disease, the
pneumococcal disease incidence has decreased by 94% in the U.S. Currently, in China, there is only one imported vaccine product against this
diseases. No domestic producer has been licensed to supply this vaccine. Our pneumococcal conjugate vaccine will primarily target children two years
old or under, who number approximately 32 million in China. We obtained the clinical trials license in January 2015. Phase I clinical trial is expected
to be commenced in the second quarter of 2016.
Rubella vaccine. Rubella is a disease caused by the rubella virus and an acute infection is usually associated with the symptoms of fever and systemic
rash. The clinical trial license was granted in December 2014. Further development of this vaccine candidate depends on the progress of developing a
measles, mumps and rubella vaccine, or MMR vaccine.
Varicella vaccine. Varicella is a highly contagious infectious disease caused by the varicella-zoster virus (herpesvirus 3, Human). It usually affects
children, is spread by direct contact or respiratory route via droplet nuclei and is characterized by the appearance on the skin and mucous membranes of
successive crops of lesions that are easily broken and become scabbed. Varicella is relatively benign in children, but may be complicated by pneumonia
and encephalitis in adults. According to the NIFDC lot release records, 18.7 million doses of varicella vaccines were approved and released in China in
2015, compared to 16.6 million doses in 2014. We had completed the pre-clinical studies of a human vaccine against varicella. The clinical trial
application was filed with CFDA in January 2013. We obtained the clinical trial license in October 2015. Phase I clinical trial is expected to be
commenced in the first half of 2016.
Sabin Inactivated Polio Vaccine. Poliomyelitis (polio) is a highly infectious viral disease, which mainly affects young children. The virus is transmitted
by person-to-person spread mainly through the fecal-oral route or, less frequently, by a common vehicle (e.g., contaminated water or food) and
multiplies in the intestine, from where it can invade the nervous system and can cause paralysis. One in 200 infections leads to irreversible paralysis
(usually in the legs). Among those paralyzed, 5-10% die when their breathing muscles become immobilized. In developing countries around the globe
including China, oral polio vaccine, or OPV, is widely utilized to eradicate polio. Although OPV is considered safe and effective, in extremely rare
instances, the live attenuated vaccine virus in OPV can cause paralysis, resulting in cases of vaccine-associated paralytic polio (VAPP) or circulating
vaccine-derived poliovirus (cVDPVs). Therefore, to eliminate the risk of such cases, OPV will be phased out from routine immunization programs
around the world. According to the Polio Eradication & Endgame Strategic Plan 2013-2018 by WHO, governments should complete, inactivated polio
vaccine, or IPV, introduction and OPV withdrawal by 2016, and include IPV and OPV in routine immunization by 2018. OPV will be phased out from
routine immunization programs around the world by 2020. Sabin IPV is safer to manufacturers and potentially more affordable as compared to the
currently available Salk IPV. The global demand for IPV is increasing as the Global Polio Eradication Initiative has called for IPV to be introduced
globally. The production capability of IPV in China proves to be limited. In 2015, approximately 56.5 million doses of polio vaccines released by
National Institute of Food and Drug Control only include 7.4 million doses of IPV. On April 3, 2014, we entered into a non-exclusive license
agreement with The Institute for Translational Vaccinology, or INTRAVACC, a governmental institute working under the Dutch Ministry of Public
Health, Welfare and Sports, to develop and commercialize sIPV for distribution in China and other countries. In collaboration with INTRAVACC, we
have completed the pre-clinical study and submitted the application for clinical trials to CFDA in October 2014. In November 2015, the clinical trial
license was obtained. Phase I/II clinical trials are expected to be commenced in the first half of 2016.
Hepatitis B vaccine. Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem. It
can cause chronic liver disease and chronic infection and puts people at high risk of death from cirrhosis of the liver and liver cancer. We have
completed pre-clinical studies and filed clinical trial application in December 2014.
New generation of hepatitis A & B vaccine. The new generation combination vaccine will contain a higher dosage of the hepatitis B component, 10µg
and 20µg for pediatric and adult formulations, respectively, to enhance the vaccine’s immunogenicity. Sinovac is developing a new generation of its
hepatitis A&B combination vaccine based on its individual hepatitis A and B vaccines. We have completed the pre-clinical studies and filed clinical
trial application in late December of 2014.
37
Research and Development
We have established a leadership position in the research and development of vaccines in China. Since our inception, we have successfully developed and
marketed Healive, Bilive, Anflu, Panflu, Panflu.1, mumps vaccine, and have made significant advances in the prevention of SARS. Please see “— Our
Products”. We believe our R&D capabilities provide us with a key competitive advantage. We intend to continue to focus our research and development efforts
on developing vaccines for infectious diseases with significant unmet medical needs, as well as the vaccine products with extensive market demand in China
and other developing countries.
In 2008, we restructured our R&D team in Beijing to better utilize our scientific and personnel resources. In 2009, we built an R&D center of approximately
13,300 square feet in the campus of our Beijing headquarters to meet our R&D demand. In 2011, we built a lab of 6,778 square feet, which is focused on
maintaining quality control of our pipeline products.
In order to achieve our R&D goal, part of our R&D strategy is to focus on in-house development and to establish collaborations with domestic and international
partners on technology and virus strains licensing. We have entered into collaborations with a group of leading universities, colleges and research institutes that
have strong vaccine research capabilities and proven track records in China. In most cases, we will own the commercial rights to the products that result from
our existing R&D strategic collaborations.
The continuous investment in R&D is one of our strategies, which, we believe, will ensure our future growth. Our research and development expenses were $9.5
million, $10.9 million and $8.1 million in 2015, 2014 and 2013, respectively. We have obtained financial support from the PRC government to conduct
preclinical and clinical research of vaccines for government-sponsored programs.
Sales and Marketing
Our sales strategy is to maintain our market share and competitive advantage in the private vaccine sales market in China while leveraging this strength to
expand market share in the government-paid market.
Although the overall vaccine market environment is challenging in 2015, total sales of our regular products increased 1.3% year over year.
We primarily rely on our own sales force to sell our products directly to CDCs in the private market. As of December 31, 2015, our in-house sales and
marketing team consisted of 172 staff members located in 31 provinces and four municipal cities throughout China. We enter into sales agreements with CDCs
each time a CDC places a purchase order. Pursuant to the sales agreements, CDCs agree not to re-sell our products to regions outside the territory the pertinent
CDC covers administratively. Our sales team maintains stable relationships with our customers by providing them with technical supports and trainings. We
believe these efforts have contributed to our reputation for quality and brand awareness in the Chinese vaccine market.
We intend to establish our presence, increase our sales to international markets and enhance awareness of our products outside of China. Our products are
currently registered in Hong Kong, Mexico, Nepal, Philippines, Mongolia, Chile, Guatemala, Bangladesh and Salvador. We have already exported some of our
products to eight countries, including Mongolia, Mexico, Philippines, Nepal, Tajikistan, Bangladesh, Chile and Guatemala. We will continue to explore the
globalization of our portfolio and develop products targeting other potential international markets where we believe we can be successful.
Seasonality
Our business is highly seasonal. For example, the influenza season generally runs from November through March of the next year, and the largest percentage of
influenza vaccinations is administered between September and November of each year. As a result, we expect to realize most of our annual revenues from Anflu
during this period. You should expect this seasonality in our business to contribute to significant quarterly fluctuations in our operating results. In the first
quarter, our strong winter-season sales are usually offset by the slow-down of business during the Chinese New Year holiday season that effectively lasts more
than half a month. During this holiday season, many businesses in China, including CDCs and most departments in hospitals, are either closed or substantially
reduce the level of their activities. Please see “Item 3. Key Information — D. Risk Factors — Risks Related to Our Company — Our business is highly
seasonal. This seasonality will contribute to our operating results fluctuating considerably throughout the year.”
38
Suppliers
We obtain the raw materials from local and overseas suppliers. We generally maintain at least two suppliers for each key raw material, with the exception of
hepatitis B antigens we use for Bilive production. We source hepatitis B antigens entirely from Beijing Temple of Heaven. Please see “Item 3. Key Information
— D. Risk Factors — Risks Related to Our Company — If any of our third-party suppliers or manufacturers cannot adequately meet our needs, our business
could be harmed.” Raw materials generally are in good supply and the prices we pay for them remain stable. We target to maintain our gross margin in the event
of rising raw materials costs by improving our production processes and technical methods.
Manufacturing, Safety and Quality Assurance
We have three manufacturing bases located in Haidian and Changping Districts of Beijing and Dalian City of Liaoning province.
We have two upstream production facilities in Haidian District, Beijing for commercialized products. Our Healive and Bilive share the same production line,
which has an aggregate annual capacity of 10 million doses. Our Anflu production line has an annual capacity of 8 million doses, which can also be used to
produce 20 million doses of Panflu or Panflu.1 annually. Our Healive, Bilive and Anflu production facilities received their GMP certificates initially in March
2002, June 2005 and October 2005, respectively, and renewed their GMP certificates for another five years in 2008, 2010 and 2010, respectively. The upstream
production plants for our hepatitis vaccines and flu vaccines in Haidian District have passed the new GMP certification and obtained the new GMP certificate on
April 17, 2013. We also have vaccine production facilities under construction at Haidian site now.
We have built a new production site in Changping District, Beijing, which comprises a new filling and packaging line that complies with the new PRC GMP
standards, EV71 production facilities and a warehouse. The EV71 vaccine production line has a designed annual capacity of 20 million doses and was granted
the GMP certificate in January 2016.
Our production site in Sinovac Dalian focuses on the research, development, manufacturing and commercialization of live-attenuated vaccines, such as
varicella, mumps and combination vaccines containing measles, mumps, rubella, and/or varicella. Sinovac Dalian has received its GMP certificate (2010
version) from the CFDA for its mumps vaccine in September 2012 and launched mumps vaccine, its first commercial product in late 2012. The production line
for the varicella vaccine is under construction.
Each of our subsidiaries has its own quality assurance departments. The quality assurance department of each subsidiary plays a role to supervise the R&D,
manufacturing, procurement, quality control, sales and marketing, logistics and plant construction of its own subsidiary under the guidance of relating
regulations and guidelines. Regular trainings or seminars are organized among quality assurance departments of each subsidiary to share and exchange
knowledge and experiences.
Sinovac has built a pharmacovigilance system. Pharmacovigilance system includes organization structure, documentation, working procedures and SOPs. The
organization structure indicates staff and relevant responsibilities. According to requirements of authorities, we report the severe Adverse Event Following
Immunization, or AEFI, in time and regularly. We summarize and analyze all safety information coming from post-marketing surveillance, phase IV clinical
trials, safety studies and literatures, to make the risk-benefit evaluation annually, and to submit the PSUR (Periodic Safety Update Reports) to authorities
regularly. Meanwhile, we are required to assist authorities to investigate on the AEFIs and provide the information as required.
Collaborations
In September 2015, Sinovac Dalian entered into a technology transfer and supply agreement with GSK, to use GSK’s measles seeds to develop combination
vaccines containing measles for the China market. Under this agreement, GSK agreed to transfer its measles seeds, provide reasonable assistance and relevant
technical materials to Sinovac Dalian for the purpose of developing and producing combination vaccines containing measles.
39
On April 3, 2014, we entered into a non-exclusive license agreement with INTRAVACC, a governmental institute working under the Dutch Ministry of Public
Health, Welfare and Sports, to develop and commercialize sIPV for distribution in China and other countries. We expect to develop and commercialize the
vaccine in China, as well as seeking regulatory approval in other countries. The agreement has a term of 50 years. Please see “— Our Products”.
We agreed to pay INTRAVACC license fee of up to $2,406 million (€1.5 million) net of PRC withholding tax, including an entrance fee and milestone
payments upon achieving specific milestones. We also agreed to pay royalty payments in a single digit percentage of net sales generated worldwide from the
product or products developed under the license agreement. We recorded an entrance fee of $0.7 million (€0.5 million) excluding PRC withholding tax for the
year ended December 31, 2014 as research and development expense. We also recorded $0.1 million (€0.1 million) for payment made to INTRAVACC for use
of sIPV viral seeds in research and development expense for the year ended December 31, 2014. No payments were made in 2015.
We licensed from MedImmune, LLC, or MedImmune, certain rights to use patented reverse genetics technology pertaining to virus strain used for the
production of Panflu (H5N1). We have agreed to pay an upfront license fee and to pay milestone payments of up to an aggregate of $9.9 million upon the
achievement of certain amount of cumulative net sales of licensed products in China (including Hong Kong and Macau), as well as royalty payments in single
digits of net sales of the licensed products in China (including Hong Kong and Macau). On August 15, 2012, we entered into amendment agreements with
MedImmune in respect of four of our patent license agreements with MedImmune to, among other things, extend the effectiveness of each agreement to reflect
revised termination dates between December 2015 and May 2021. We accrued license fee and royalties of $3.4 million at the end of 2011 which were paid in
2012. We did not make any royalty payment in 2013 but made a $0.9 million royalty payment in May 2014. No royalties were incurred or paid for the year
ended December 31, 2015.
In March 2009, we entered into a technology transfer agreement with Tianjin CanSino Biotechnology Inc. or Tianjin CanSino, a third party company, to
develop a 7-valent pneumococcal conjugate vaccine. According to the agreement, Tianjin CanSino will transfer the technology of a pneumococcal vaccine to us.
The collaboration term under the technology transfer agreement is from the signing date to eight years after the first sales of the vaccine developed under the
technology transfer agreement in the Chinese market. Under this technology transfer agreement, we agreed to make milestone payments of up to $3 million and
royalty payment ranging from 6% to 10% for the net sales in the Chinese market. Each of the future milestone payments is subject to certain conditions,
including the PRC government approvals at different stages, which are uncertain. We also agreed to make royalty payments for eight years after the first sales of
the vaccine developed under the technology transfer agreement in the Chinese market. The sales of the pneumococcal vaccine in the Chinese market are also
subject to the PRC government approval. Both parties agreed to work together to develop international markets for the products. On November 9, 2009 and
December 14, 2011, we entered into two amendments to the technology transfer of another six serotypes and related technology to us for $0.3 million to
develop a 13-valent pneumococcal conjugate vaccine. On January 29, 2015, we entered into the third amendment to the technology transfer agreement dated
March 12, 2009 and the first two amendment agreements dated November 17, 2009 and December 24, 2011. By entering into this third amendment, the
technology agreement was revised to be a licensing agreement. The remaining milestone payments under the agreements were reduced. Both Sinovac and
Tianjin CanSino are free to develop PCV vaccines or to collaborate with one other company for the same purpose. As of December 31, 2015, we made total
milestone payments of $1.5 million ($1.0 million under the March 2009 agreement, $0.2 million under the November 2009 and December 2011 amendments,
and $0.3 million under the January 2015 amendments).
On August 18, 2009, we entered into a patent license agreement with the National Institutes of Health, or NIH, an agency of the United States Public Health
Services within the Department of Health and Human Services. NIH has granted us a non-exclusive license to make and use certain of its products. NIH has also
granted us the right to use certain associated information for development of its licensed products. The collaboration term under the patent license agreement is
from August 18, 2009 to the later of (a) the expiration of all royalty obligations under the licensed rights where such rights exist and (b) eight years after the first
commercial sale by us, unless the agreement is terminated earlier per the provisions included therein. We agreed to pay NIH a license issue royalty of $0.1
million upon execution of the agreement and a non-refundable minimum annual royalty of $8,000, and royalty payments on net sales ranging from 1.5% to
4.0% depending on the sales territory and the customers. We also agreed to pay NIH benchmark royalties of $0.3 million upon achieving each benchmark as
specified in the patent license agreement, including completion of clinical trials, obtaining regulatory approval for marketing, and achievement of commercial
sales.
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In December 2004, we signed a pandemic influenza vaccine co-development agreement with China CDC to jointly develop a pandemic influenza vaccine.
Pursuant to this co-development agreement, we agreed, among other things, to conduct pandemic influenza vaccine R&D based on our established vaccine
R&D technical platform and to apply for the new drug certificate, production license and patents for the pandemic influenza vaccine. China CDC agreed, among
other things, to strategize development of the pandemic influenza vaccine, provide us with scientific guidance to vaccine technicalities and conduct certain
pandemic related research and vaccine development-related analysis and testing. Both parties agreed to be responsible for certain specified expenditures
associated with the vaccine development and to jointly apply for government R&D funds. However, the co-development agreement expressly provides that we
will be the applicant for and owner of the future new drug certificate, production license and any patent or know-how in connection with the pandemic influenza
vaccine. In return, we have agreed to fund and support China CDC’s influenza-related investigation and other pandemic control efforts after we gain profits
from the sale of pandemic influenza vaccines. The regulatory approval for production of our whole viron pandemic influenza vaccine was obtained in April
2008.
Competition
The pharmaceutical, biopharmaceutical and biotechnology industries both within China and globally are intensely competitive and are characterized by rapid
and significant technological progress, and our operating environment is increasingly competitive. In recent years, the CFDA increased the quality standard of
some vaccine products by issuing a new version of Pharmacopeia. As a result, some vaccine products manufactured by multinational companies can no longer
be sold in China. According to the CFDA, there are approximately 40 vaccine companies in China, of which we believe approximately ten are our direct
competitors. In addition, multinational companies have started to localize their vaccine production in China, which is expected to further intensify the
competition.
Even with the advent of private medical and healthcare insurance programs in China and the government vaccine purchase program’s expanded vaccine list,
most Chinese citizens must pay for their own vaccines because these insurance programs do not typically cover vaccines and the government vaccine purchase
program covers only infants and young children. We believe the consumer market is health conscious yet price sensitive and accordingly would favor our
products over both cheaper but not enough high quality vaccines provided by local manufacturers and comparable quality but more expensive vaccines
manufactured by some of our international competitors. Our competitors, both domestic and international, include large integrated multinational pharmaceutical,
domestic state-owned entities and domestic private companies that currently engage in, have engaged in or may engage in efforts related to the discovery and
development of new biopharmaceuticals and vaccines. Many of these entities have substantially greater research and development capabilities and financial,
scientific, manufacturing, marketing and sales resources than we do, as well as more experience in research and development, clinical trials, regulatory matters,
manufacturing, marketing and sales, although these advantages are not comprehensive.
There are multiple vaccine products approved for sale worldwide. Many of these vaccine products are marketed by our major competitors and are in the areas of
hepatitis A, hepatitis B and influenza. Specifically, with respect to the inactivated hepatitis A vaccine, we consider Kunming Institute of Biological Product,
Sanofi Pasteur and Merck Sharp & Dohme Corp. as key competitors in the China market, and GlaxoSmithKline Biologicals, Merck Sharp & Dohme Corp. and
Changchun Institute of Biological Products for the markets outside of China. While in China, according to the batch release number published by NIFDC, over
80% of hepatitis A vaccines released in China are live attenuated vaccine, another type of hepatitis A vaccine compared to inactivated version, which is the
biggest competitor for inactivated hepatitis A vaccine. The live attenuated hepatitis A vaccine manufacturers include Kunming Institute of Biological Product,
Pukang Biological Co., Ltd., Changchun Institute of Biological Products and Changchun Changsheng Life Sciences Ltd. With respect to the hepatitis A and B
vaccines, we are the only company to supply hepatitis A and B vaccine in China. With respect to the influenza vaccines, in China, we consider Hualan
Biological Engineering Inc., Changchun Institute of Biological Products, Sanofi Pasteur S.A., Changchun Changsheng Life Sciences Ltd., Aleph Biological Co.,
Ltd. (Dalian Yalifeng) and multinational companies including GlaxoSmithKline Biologicals, Sanofi Pasteur S.A. as our major competitors for the market
outside of China. With respect to the EV71 vaccines, Kunming Institute of Biological Product and we have received new drug certificate, production license and
GMP certificate. China National Biotec Group Co., Ltd. has filed new drug application for EV71 vaccines. We consider Kunming Institute of Biological
Product and China National Biotec Group Co., Ltd. as our major potential competitors of the EV71 vaccines.
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We believe we enjoy a number of advantages over our PRC domestic and multinational competitors. Generally, we believe that the principal competitive factors
in the markets for our products and product candidates include:
safety and efficacy profile;
brand reputation;
product supply; and
post-sales service.
Intellectual Property and Proprietary Technology
Protection of our intellectual property and proprietary technology is very important for our business. We rely primarily on a combination of trademark, patent
and trade secret protection laws in China and other jurisdictions, as well as employee and third-party confidentiality agreements to safeguard our intellectual
property, know-how and our brand. Our ability to protect and use our intellectual property rights in the continued development and commercialization of our
technologies and products, operate without infringing the proprietary rights of others and prevent others from infringing our proprietary rights is crucial to our
continued success. We will be able to protect our products and technologies from unauthorized use by third parties only to the extent that they are covered by
valid and enforceable patents, trademarks or copyrights, or are effectively maintained as trade secrets, know-how or other proprietary information.
We have a total of 29 issued patents and a number of pending patent applications relating to our vaccines in China. Our hepatitis A vaccine and seasonal
influenza vaccine have five and three issued patents for protection, respectively.
With respect to, among other things, proprietary know-how that is not patentable and processes for which patents are difficult to enforce, we rely on trade secret
protection and confidentiality agreements to safeguard our interests. We believe that many elements of our vaccine products, clinical trial data and
manufacturing processes involve proprietary know-how, technology or data that are not covered by patents or patent applications. We have taken appropriate
security measures to protect these elements. We have entered into confidentiality agreements (which include, in the case of employees, non-competition
provisions) with many of our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements provide that
all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and
not disclosed to third parties except in specific circumstances. In the case of our employees, the agreements provide that all of the technology which is
conceived by the individual during the course of employment is our exclusive property and require our employees to assign to us all of their inventions, designs
and technologies they develop during their terms of employment with us and cooperate with us to secure patent protection for these inventions if we wish to
pursue such protection.
We relied on administrative protection afforded new drugs through the monitoring period provided by the CFDA in the past. During the monitoring period, third
parties’ applications for manufacturing or importing the same drug are not accepted by the CFDA. The administrative protection for Healive expired in
December 2007 and Bilive expired in January 2008. We may get new drug protection for new products to be commercialized in China through the same way.
We maintain 20 registered trademarks in China, including (i) Sinovac, (ii) Sinovac’s Chinese name and its logo, (iii) Healive, its Chinese name and its logo, (iv)
Bilive and its Chinese name, (v) Anflu and its Chinese name, (vi) Panflu, its Chinese name and its logo, (vii) PANFLU.1 and its Chinese name, (viii) Chinese
name of EV71 vaccine and (ix) EV71Vac and EntV71. We have registered “Sinovac” trademark in Canada, Malaysia, Philippines and the United States. We
have registered “Sinovac” as trademarks under the “Madrid international trademark registration system,” which can be used in the member countries of Madrid
Union, including France, United Kingdom and Germany. Since the “Sinovac” trademark certificates of Columbia, India and Thailand have already been
expired, we now deal with their renewal procedures.
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We currently use “科兴” (Kexing) as part of Sinovac Beijing’s Chinese trade name in the PRC. We also use “科兴” (Kexing) as part of the Chinese trade name
of Sinovac Dalian in the PRC. Shenzhen Kexing currently owns the “科兴” trademark registered in China for Class 5 (Pharmaceuticals) under the International
Classification of Goods and Services. To protect our interest in using “科兴” in our trade name, we applied to register “科兴” in China for Class 42 (Scientific
& Technological Services & Research) in 2006 and the PRC Trademark Office of the State Administration for Industry and Commerce approved our
application in 2010. The “科兴” trademark owned by Shenzhen Kexing has not been identified as “Well-known Trademark” by the relevant PRC authorities
since we first started using “科兴” in the trade name of Sinovac Beijing in 2001. If the “科兴” trademark owned by Shenzhen Kexing is ever officially
identified as a “Well-Known trademark,” however, we may be subject to trademark infringement claim for the use of “科兴” in our trade name. Although the
trademark application and the trade name approval systems are administered separately in China, it is possible that we may lose our ability to use the “科兴”
trademark in our trade name due to a successful trademark infringement claim, which may adversely affect our ability to maintain and protect our brands, cause
us to incur litigation costs and divert resources and management attention. As our brand name is becoming more recognized in the vaccine market, we are
working to maintain, increase and enforce our rights in our trademark portfolio, the protection of which is important to our reputation and branding.
We have registered our domain names, including www.sinovac.com.cn and www.sinovac.com, with the China Internet Network Information Center.
Insurance
We maintain property insurance coverage with an annual aggregate insured amount of approximately RMB539.0 million ($83.2 million) to cover our property
and facilities from claims arising from fire, earthquake, flood and a wide range of other natural disasters. Our worldwide product liability insurance of Healive,
Bilive, Anflu and Panflu (excluding U.S. and Europe) from March 2015 to March 2016 is limited. Moreover, we do not carry liability insurance to cover
liability claims that may arise from the incidents relating to the clinical trials of our vaccine products. Our insurance coverage may not be sufficient to cover any
claim for product liability or damage to our fixed assets. We do not maintain any business interruption insurance. We are carrying worldwide product liability
insurance for Healive, Bilive, Anflu and Panflu (excluding U.S. and Europe) from March 2015 to March 2016 with the premium of $53,000. We are currently
negotiating with the insurance providers for a renewal of our product liabilities insurance policies. See “Item 3. Key Information — D. Risk factors — Risks
Related to Our Company — We could be subject to costly and time-consuming product liability actions and carry limited insurance coverage.”
Regulatory Framework of the Pharmaceutical Industry in the PRC
The testing, approval, manufacturing, labeling, advertising and marketing, post-approval safety reporting, and export of our vaccine products or product
candidates are extensively regulated by governmental authorities in the PRC and other countries.
In the PRC, the CFDA regulates and supervises biopharmaceutical products under the Pharmaceutical Administration Law, the Implementing Regulations on
Pharmaceutical Administration Law, the Administration of Registration of Pharmaceuticals Procedures, and other relevant rules and regulations which are
applicable to manufacturers in general. Every step of our biopharmaceutical production is subject to the requirements on the manufacture and sale of
pharmaceutical products as provided by these laws and regulations, including but not limited to, the standards of clinical trial, declaration, approval and transfer
of new medicine registrations, applicable industry standards of manufacturing, distribution, packaging, advertising and pricing.
Pre-clinical Studies. Pre-clinical studies include in-vitro laboratory evaluation of the product candidate, as well as in-vivo animal studies to assess the potential
safety and efficacy of the product candidate. Pre-clinical studies must be conducted in compliance with Good Laboratory Practice for Non-clinical Studies of
Pharmaceuticals. With respect to vaccines, the pre-clinical studies should also comply with Technical Guidance for Pre-clinical Studies on Preventive Vaccines.
We must submit file package for investigational new drug application, or IND, to the provincial level CFDA. The files should include pharmaceutical research,
pharmacology and toxicology research, together with the records of manufacturing and testing and the sample of product candidate. We cannot commence
clinical trials until we get approval of IND. We cannot assure that submission of an IND will result in the CFDA allowing clinical trials to begin, or that, once
begin, issues will not arise that result in the suspension or termination of such clinical trials.
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Clinical trials. Clinical trials involve the administration of the product candidate to healthy volunteers or vaccinees under the supervision of principal
investigators, who are generally physicians or an independent third party not employed by us or under our control. Clinical trials typically are conducted in three
sequential phases, but the phases may overlap or be combined. In phase I, the initial introduction of the drug into human subjects, the drug is usually tested for
safety (adverse effects), dosage tolerance, and pharmacologic action. Phase II usually involves studies in a limited vaccinee population to evaluate preliminarily
the efficacy of the drug for specific, targeted conditions and to determine dosage tolerance, appropriate dosage and to identify possible adverse effects and
safety risks. Phase III trials generally further evaluate clinical efficacy and test further for safety within an expanded vaccinee population. Clinical trials have to
be conducted in compliance with the Good Clinical Trial Practice of Pharmaceuticals. With respect to vaccines, we also have to comply with the CFDA’s
Requirements on Application for Clinical Trial of New Preventive Biological Products. The sample vaccine products must be tested by the NIFDC before they
may be used in the clinical trials. We or the CFDA may suspend clinical trials at any time on various grounds, including a finding that subjects are being
exposed to an unacceptable health risk.
After three phases of clinical trials, we apply for New Drug Application, or NDA. We submit to the provincial level CFDA the NDA file package, which
includes clinical trial research report, pharmaceutical research data, and records of manufacturing and testing of three batches of product, to apply for a new
drug certificate and/ or production license. For vaccines, we have to comply with the CFDA’s Guidelines for Clinical Trial Report on Vaccines.
New Drug Certificate. The provincial level CFDA will conduct a preliminary examination of our application for a new drug certificate. Once it decides to
accept our application based upon such preliminary examination, the provincial level CFDA will, within five days, conduct an on-site examination on the
circumstances of our clinical trials and pharmaceutical research. Then the provincial level CFDA will submit its opinion, together with our application materials,
to the Centers for Drug Evaluation. The Centers for Drug Evaluation will review our application materials, and give their technical opinion to CFDA. The
CFDA will decide whether or not to issue a new drug certificate to us. We consider obtaining the new drug certificate for our product candidates a significant
milestone in our business.
Production Permit. Simultaneously with the application of new drug certificate, we also apply to the provincial level CFDA for a production license to
manufacture the new drug to be approved by the CFDA. The production license application will be examined with similar stage procedure as for the new drug
certificate, first by the provincial level CFDA followed by the Centers for Drug Evaluation, and the CFDA the last. After the provincial level CFDA accepts the
application, conducts the on-site examination and forms its opinion, the provincial level CFDA will transfer the file to the Centers for Drug Evaluation, and the
Centers for Drug Evaluation will review the application files and give technical opinion. If the Centers for Drug Evaluation is satisfied with our application
materials, it will notify us to apply for the on-site production inspection within six months after being so notified. The Center for Food and Drug Inspection will
conduct an on-site inspection on our production procedures within 30 days after receipt of our application and take samples from three batches of our products,
and the NIFDC will test the selected samples and later submit its testing reports to the Centers for Drug Evaluation. The Center for Food and Drug Inspection
must submit the on-site production inspection report to Center for Drug Evaluation. The Centers for Drug Evaluation will form a comprehensive opinion based
upon the technical review and evaluation opinion, the on-site production inspection report and the testing results of the samples, and submit its opinion and
relevant materials to the CFDA. The CFDA will decide whether or not to issue the production permit to us. If the product approval and production approval
both meet the criteria, the CFDA will issue the production permit together with the new drug certificate at the same time. The production permit is valid for a
term of five years and must be renewed before its expiration. During the renewal process, our production facilities will be re-evaluated by the appropriate
governmental authorities and must comply with the effective standards and regulations.
Under certain circumstances, for instance, where drugs are developed to cure a disease without effective therapeutic methods, the CFDA provides a special
proceeding for its review of the new drug certificate application and production permit application relating to such drugs.
The CFDA will specify a monitoring period ranging from three to five years when approving the first production permit for most new drugs. During this
monitoring period, the manufacturers holding the new drug certificates must regularly report, among other things, the production process, efficacy, stability and
side effects of the new drugs involved to the provincial level CFDA. During the same period, the CFDA will not accept any new application for approval of the
same drug involved. However, if a third party has filed an application for the same drug and obtained the clinical trial permit before the monitoring period
commences, the third party may still obtain a new drug certificate and production permit for the same drug.
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We may also be required to conduct clinical trials prior to commencing the manufacturing of pharmaceutical products for which there are published state
pharmaceutical standards.
GMP Certificate. After receiving the on-site inspection notification for production permit, we should submit the GMP inspection application to the Center for
Food and Drug Inspection as well. The Center for Food and Drug Inspection will arrange for the inspection on our facilities for both purposes of GMP
inspection and production permit at the same time. If we pass the GMP inspection, CFDA will issue the GMP Certificate after we get the Production Permit. A
GMP Certificate is used to approve the quality system, including quality assurance and quality control management, production management, material and
product, qualification and validation, facility and equipment, etc. The CFDA has issued GMP standards for pharmaceutical manufacturers to minimize the risks
arising out of the production process of drugs that will not be identified or eliminated through testing the final products.
A GMP Certificate is valid for five years and we should apply for a renewal of our GMP Certificate no later than six months prior to the expiration of our GMP
Certificate.
We cannot commence the manufacture of a new drug unless and until we have obtained a valid new drug certificate, production permit and GMP Certificate.
Batch Approval. Our vaccine products cannot be distributed in the market before receiving batch approval. After we get the GMP certificate, we will start the
commercial production, after which we need to apply for batch release approval by the NIFDC for the commercial lots. For each batch of products, we will
provide samples taken from cold rooms by inspectors, together with manufacturing records, self-testing records and other quality control documents. The
NIFDC will review the documents and test the samples and issue a batch approval within approximately two months if our manufacture procedures and the
quality of our products meet CFDA standards. With the batch approval, we may distribute the approved batch of vaccines to the market.
C. Organizational Structure
The following diagram illustrates our company’s organizational structure, and the place of incorporation, ownership interest and affiliation of each of our
subsidiaries as of the date of this report.
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* Dalian Jin Gang Group Co., Ltd. owns the remaining 45% equity interest in Sinovac Dalian.
** Sinobioway Bio-medicine Co., Ltd., formerly named Xiamen Bioway Group Co., Ltd, owns the remaining 26.91% equity interest in Sinovac Beijing.
*** The former name is Beijing Sinovac Biological Technology Co., Ltd.
**** The former name is Sinovac Zhong Yi Bio-pharmaceutical Co., Ltd.
D. Property, Plants and Equipment
We are headquartered in the Peking University Biological Industry Park (Haidian) in Beijing in a 48,900-square-foot facility, of which approximately 16,700
square feet are used as office space and approximately 32,200 square feet are used for the production plant for Healive and Bilive, where the production
equipment for hepatitis vaccines is located. We own the above-described 48,900-square-foot facility in Beijing. In August 2004, we signed two 20-year leases
with SinoBioway Biotech Group Co. Ltd., or SinoBioway, pursuant to which we leased two buildings of approximately 28,000 and 13,300 square feet,
respectively, located at the Peking University Biological Park in Beijing. We house our Anflu manufacturing and R&D center in these two buildings. One of the
lease agreements was amended on August 12, 2010 to reflect an increase in the lease payment. In June 2007, we signed another 20-year lease with SinoBioway,
in order to expand Sinovac Beijing’s production facilities in Beijing, pursuant to which we leased one building of approximately 37,000 square feet, located at
Peking University Biological Park. Part of our administrative offices and filling facilities are located in this building until 2013. The filling facilities were
moved to Changping site in 2013, where we are setting up the commercial production facility for our pneumococcal vaccines. In September 2010, we entered
into an agreement with SinoBioway, under which we lease a space of 6,778 square feet. The lease term is five years and we used it for our research and
development function. On April 8, 2013, we entered into three supplemental agreements with SinoBioway, under which the expiration date of each of the four
operating lease agreements was extended to April 7, 2033.
We have three production lines located in the Peking University Biological Park (Haidian). Our production line to manufacture our hepatitis vaccines, Healive
and Bilive, interchangeably has an aggregate combined production capacity of approximately 10 million doses annually. Our production line to manufacture our
flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of approximately eight million doses of Anflu (northern
hemisphere), or the equivalent of 20 million doses of Panflu or 20 million doses of Panflu.1. We have also built Pneumococcal Polysaccharide Vaccine
production line at Haidian site with designed annual capacity of five million doses per year. In May 2013, our new filling and packaging line in Changping site
was granted the new GMP certificate, after which we moved the filling and packaging activities to our Changping site.
In February 2010, we acquired a right to use approximately 312,400 square feet of land located in Changping District, Beijing, or Changping Site, with five
buildings with a total built-out area of 32,322 square meters (approximately 347,900 square feet) on 29,021 square meters (for a total consideration of
approximately RMB123.6 million ($19.1 million). We have made all required payments by December 31, 2012. We have built a new filling and packaging line,
EV71 production facilities and a warehouse on the Changping site. The new filling and packaging line and warehouse commenced operation in May 2013 and
December 2010, respectively. The EV71 vaccine production line has a designed annual capacity of 20 million doses and was granted the new GMP certificate in
January 2016.
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In November 2009, we entered into an agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, we established Sinovac Dalian
which focuses on the research, development, manufacturing and commercialization of live-attenuated vaccines, such as varicella, mumps and rubella vaccines
for human use. Sinovac Dalian has seven existing buildings with a total built-out area of 20,000 square meters (approximately 215,280 square feet) on 95,685
square meters (approximately 1,030,000 square feet) of land, located at DD Port, Economic and Technical Development Zone, Dalian City, Liaoning province.
Sinovac Dalian received its GMP certificate (2010 version) from the CFDA for its mumps vaccine in September 2012.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial
statements and the related notes included elsewhere in this annual report on Form 20-F. This discussion may contain forward-looking statements based upon
current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as
a result of various factors, including those set forth under “Item 3. Key Information — D. Risk Factors” or in other parts of this annual report on Form 20-F.
A. Operating Results
Overview
We are a fully integrated, China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of
vaccines against infectious diseases. We have successfully developed a portfolio of products, consisting of vaccines against hepatitis A, hepatitis B, influenza
viruses and mumps. The following table sets forth certain information on our commercialized products.
Products
Healive
Bilive
Anflu
Panflu(1)
Panflu.(1)
Mumps
Date of Approval
May 2002
June 2005
October 2005
April 2008
September 2009
September 2012
2015
4.1 million
2.3 million
3.2 million
1.1 million
nil
1.2 million
Number of Doses Sold
2014
3.9 million
2.6 million
3.4 million
40,000
nil
1.7 million
2013
4.1 million
2.5 million
3.4 million
3.0 million
nil
1.2 million
(1) We sold all of our Panflu and Panflu.1 products to the PRC government. Our sales of Panflu and Panflu.1 depend on the completion of government audit on
our fulfillment to the stockpiling order. In 2015, 1.1 million doses of Panflu products manufactured for the government stockpiling order were not used and
expired, allowing us to recognize sales revenue. Sales of Panflu generated revenues of $3.9 million in 2015.
Our pipeline consists of various vaccine candidates in the pre-clinical and clinical trial development phases in China. We completed three phases of clinical
trials on our EV71 vaccine and the phase III clinical results showed our EV71 vaccine candidate has an efficacy rate of 94.8% against HFMD among infants and
young children. We obtained new drug certificate and production license for our EV71 vaccine in December 2015, and obtained the GMP certificate in January
2016. In addition, we filed applications to conduct clinical trials for pneumococcal conjugate vaccine, pneumococcal polysaccharide vaccine and rubella vaccine
in early 2011. We filed an application for the clinical trial of varicella vaccine in January 2013. We obtained the approvals to conduct clinical trials of
pneumococcal polysaccharide vaccine, rubella vaccine, pneumococcal conjugate vaccine and sIPV vaccine in May 2014, December 2014, January 2015 and
December 2015, respectively.
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Our Proprietary Rights
Healive was co-developed by Tangshan Yian and the NIFDC. In April 2001, Tangshan Yian contributed its proprietary rights to Healive to Sinovac Beijing as
its capital contribution to Sinovac Beijing. In 2002, the NIFDC, Tangshan Yian and Sinovac Beijing agreed that Sinovac Beijing owns the right to market and
sell Healive, and that Sinovac Beijing was required to pay the NIFDC approximately $1 million for the Healive technology consulting fee that Tangshan had not
paid by that time. We obtained Healive’s new drug certificate from the CFDA in December 1999, the production license in May 2002, and final PRC regulatory
approval for production of Healive in May 2002. Production of Healive commenced in July 2002.
Bilive was initially developed by Tangshan Yian. In March 2002, Tangshan Yian and Beijing Keding entered into an agreement under which Tangshan Yian
transferred to Beijing Keding its proprietary rights to Bilive at no cost. In August 2002, Sinovac Beijing acquired the proprietary rights to Bilive from Beijing
Keding in consideration of a 10.7% equity interest in Sinovac Beijing and a cash payment of $18,000. Beijing Keding is owned by Dr. Weidong Yin and three
other senior officers of Sinovac Beijing. We received the production license for Bilive from the CFDA in January 2005. In June 2005, we obtained the final
PRC regulatory approval for production of Bilive. The cost of the proprietary rights to Bilive was expensed as purchased in-process research and development.
Production of Bilive commenced in June 2005.
In March 2003, Sinovac Beijing acquired the proprietary rights to Anflu from Tangshan Yian at the vendor’s cost. In November 2004, we completed the
acquisition of 100% of the shares of Tangshan Yian. We received the final PRC regulatory approval for the production of Anflu in October 2005. The cost of
the proprietary rights to Anflu was expensed as purchased in-process research and development.
Sinovac Beijing started to research and develop the H5N1 vaccine in 2004. In 2004, Sinovac Beijing entered into an agreement with the National Institute for
Biological Standards and Controls, or NIBSC, an England based laboratory under the WHO, on transferring the H5N1 virus strain. According to the agreement,
Sinovac Beijing as the recipient would receive the materials and information from NIBSC. The agreement indicated that Sinovac Beijing can only use received
materials and information for academic in-house research purposes and Sinovac Beijing shall negotiate with the owner of reverse genetics technology pertaining
to virus strain for any commercial purpose. In April 2008, Sinovac Beijing received a production license for H5N1 from the PRC government and started to
produce H5N1 vaccines for the government-stockpiling program in June 2008.
In 2011, we licensed from MedImmune certain rights to use patented reverse genetics technology pertaining to virus strain production for H5N1 influenza
vaccine. We have agreed to pay an upfront license fee, milestone payments up to an aggregate of $9.9 million based upon the achievement of cumulative net
sales of licensed products in China (including Hong Kong and Macau), as well as royalty payments in single digit of net sales of the licensed products in China
(including Hong Kong and Macau). On August 15, 2012, we entered into amended agreements with MedImmune to, among other things, extend the
effectiveness of each agreement to reflect revised termination dates between December 2015 and May 2021. License fee and royalties of $3.4 million accrued at
the end of 2011 was paid in 2012. No payments were made in 2013 and 2015. We made $0.9 million royalty payment to MedImmune in 2014.
Amortization expense for these proprietary rights was $0.4 million, $0.4 million and $0.4 million in 2015, 2014 and 2013, respectively.
Research and Development Programs
The research and development strategy is developed by management and reviewed and approved by the board of our company. Leveraging resources and
platform that each subsidiary has, the R&D team of each subsidiary selects a R&D project and develops a feasibility analysis to be submitted for review and
approval. Once the project is approved, we will track the R&D progress as well as the spending of each project. Each year all the ongoing R&D projects will be
reviewed along with the budgeting for the following year. We also use our research and development resources, including employees and our technology, across
multiple product development programs. The table below presents our best estimate of our total research and development costs allocable to our leading
research and development programs for the periods indicated. We have allocated direct and indirect costs to each program based on certain assumptions and our
review of the status of each program, payroll related expenses and other overhead costs based on estimated usage by each program.
48
Research and development programs
EV71 vaccine
Pneumococcal polysaccharide vaccine
Varicella vaccine
sIPV
Pneumococcal Conjugate Vaccine
Mumps vaccine
Others
Total
2015
Year ended December 31,
2014
(in thousands)
2013
$
$
325
2,816
1,650
1,617
1,155
235
1,692
9,490
$
$
1,521
2,363
1,050
3,170
682
147
2,001
10,934
$
$
2,571
440
945
187
1,358
227
2,400
8,128
The process of developing, obtaining and maintaining regulatory approvals for new products is lengthy, expensive and uncertain. While the development may
take years to complete, the market environment may change from the time when the project is selected, which will have an impact to the expected return of the
investment. We anticipate that we will frequently monitor the progress of each key project and determine which of our early stage product candidates is best
suited for further development, as well as how much funding to direct to each program, on an on-going basis in response to the scientific and clinical success
and commercial potential of each product candidate.
We have obtained the new drug certification, production license and GMP certification for our new core product, the EV71 vaccine. We have started the
commercial production and expect to launch the sales of EV71 by the first half of 2016. We also began phase III clinical trials for the pneumococcal
polysaccharides vaccine in April 2015, and acquired clinical trial licenses for the Sabin-IPV vaccine, varicella vaccine and pneumococcal conjugate vaccine.
Government Grants
Deferred government grants represent funding received from the government for research and development, or investment in building or improving production
facilities. The amount of deferred government grants as of year-end is net of research and development expenditures or depreciation incurred or those
recognized as government grant income. We received RMB1.5 million ($0.2 million), RMB21.7 million ($3.5 million) and RMB5.2 million ($0.8 million) in
2015, 2014 and 2013, respectively. In addition, we received RMB1.9 million ($0.3 million) interest subsidy, rental fee subsidy and other government grants
recognized in statements of comprehensive income (loss) in 2015.
Deferred government grants included RMB7.3 million ($1.1 million), representing the unamortized portion of the amount that we received in 2007 for
construction of a pandemic influenza vaccine plant and buildings of RMB20.0 million ($3.1 million) (RMB9.1 million ($1.5 million) as of December 31, 2014).
Out of such RMB7.3 million ($1.1 million), RMB1.8 million ($0.3 million), which will be amortized in 2016, was included in the current portion and RMB5.5
million ($0.8 million), which will be amortized after 2016, was included in the non-current portion of the deferred government grants. The production facility
grant requires us to have the entire facility available to manufacture pandemic influenza vaccines at any given moment upon request by the PRC government.
We have fulfilled the conditions attached to the government grant. Government grant relating to these production facilities of $0.3 million, $0.3 million and $0.2
million for the years ended December 31, 2015, 2014 and 2013, respectively, were recorded as a reduction to depreciation expense for those respective years.
49
Deferred government grants also included RMB3.0 million ($0.5 million) being the unamortized portion of the amount that we received in 2009 for purchasing
equipment for H1N1 vaccine production with a total amount of RMB6.2 million ($1.0 million). The amount of RMB0.8 million ($0.1 million) which will be
recognized in 2016 was included in the current portion and the amount of RMB2.2 million ($0.3 million) which will be recognized after 2016 was included in
the non-current portion of deferred government grants. We have fulfilled the conditions attached to the government grant. Government grant relating to this
production facility of $0.1 million, $0.1 million and $0.1 million for the years ended December 31, 2015, 2014 and 2013, respectively, were recorded as a
reduction to the related depreciation expense.
Deferred government grants also included RMB0.4 million ($61,000), which represents the unamortized portion of the amount that we received in 2013 for
purchasing equipment for H5N1 vaccine production. We have fulfilled the conditions attached to the government grant. The amount of RMB0.1 million
($15,000) to be amortized in 2016 was included in the current portion and the amount of RMB0.3 million ($46,000) to be amortized after 2016 was included in
the non-current portion of deferred government grants. Government grant relating to this production facility of $16,000 and $16,000 for the year ended
December 31, 2015 and 2014 were recorded as a reduction to the related depreciation expense, respectively.
We received a government grant in the amount of RMB20.0 million ($3.1 million) for equipment purchase and construction of the EV71 vaccine production
facility. As of December 31, 2015, we have not fulfilled the conditions attached to the government grant. We obtained GMP certificate of the EV71 vaccine
issued by the CFDA in January 2016, which was the final major condition attached to the grant. The amount of RMB1.7 million ($0.3 million) to be amortized
in 2016 was included in the current portion and the amount of RMB18.3 million ($2.8 million) to be amortized after 2016 was included in the non-current
portion of deferred government grants.
Deferred government grants also include RMB0.5 million ($77,000) that we received in 2015 for EV71 research and development. As we have obtained the
GMP certificate of our EV71 vaccine and expect to fulfill the conditions within one year, the grant is recorded as a current deferred government grant. As of
December 31, 2015, we have obtained the new drug certificate and production license of EV71 vaccine issued by the CFDA, and have fulfilled the conditions
attached to three government grants received in prior years for EV71 research and development with a total amount of RMB10.0 million ($1.6 million). These
grants were recognized as government grant recognized in income for the year ended December 31, 2015.
We received a loan of RMB12.0 million ($1.9 million) bearing an interest rate of 0.36% per year from Beijing Zhongguancun Development Group. The fair
value differential (between the face value and the fair value using the effective interest rate method at our borrowing rate of 6.9%) is recorded as current
deferred government grant of $0.4 million as of December 31, 2015 ($0.4 million as of December 31, 2014).
Deferred government grants also include RMB4.9 million ($0.8 million) in relation to four other research projects. As of December 31, 2015, the conditions
attached to three of the four government grants totaling RMB4.4 million ($0.7 million) (RMB4.0 million ($0.6 million) as of December 31, 2014) have not been
fulfilled by us. As we do not expect to fulfill the conditions within one year, these grants are recorded as non-current deferred government grants. We expect to
fulfill the conditions attached to one of the four grants within one year, and therefore recorded RMB0.5 million ($78,000) as of December 31, 2015 (RMB0.5
million ($81,000) as of December 31, 2014) as a current deferred government grant.
Critical Accounting Policies and Estimates
Our consolidated financial information has been prepared in accordance with U.S. GAAP, which requires us to make judgments, estimates and assumptions that
affect (1) the reported amounts of our assets and liabilities, (2) the disclosure of our contingent assets and liabilities at the end of each fiscal period and (3) the
reported amounts of revenues and expenses during each fiscal period. We continually evaluate these estimates based on our own historical experience,
knowledge and assessment of current business and other conditions, our expectations regarding the future based on available information and reasonable
assumptions, which together form our basis for making judgments about matters that are not readily apparent from other sources. Since the use of estimates is an
integral component of the financial reporting process, our actual results could differ from those estimates. Some of our accounting policies require a higher
degree of judgment than others in their application.
When reviewing our financial statements, you should consider (1) our selection of critical accounting policies, (2) the judgment and other uncertainties affecting
the application of those policies and (3) the sensitivity of reported results to changes in conditions and assumptions. We believe the following accounting
policies involve the most significant judgment and estimates used in the preparation of our financial statements.
50
Revenue Recognition
Revenue is recognized when persuasive evidence of an arrangement exists, the price is fixed and determinable, delivery has occurred and there is a reasonable
assurance of collection of the sales proceeds. We generally obtain purchase authorizations from our customers for a specified amount of products at a specified
price and consider delivery to have occurred when the customer takes title of the products. We provide certain customers with a right of return.
Revenue for inactivated hepatitis A, combined inactivated hepatitis A&B and seasonal influenza vaccines are recognized when delivery has occurred and we
estimate return provisions for these products. The product return provisions for inactivated hepatitis A vaccine and combined inactivated hepatitis A&B vaccine
are estimated based on historical return and exchange levels as well as the inventory levels and the remaining shelf lives of the products in the distribution
channels. As of December 31, 2015, the sales return provision for inactivated hepatitis A vaccine and combined inactivated hepatitis A&B vaccine was $5.9
million ($3.6 million as of December 31, 2014). Sales return provision for the year for private pay market sales on inactivated hepatitis A and combined
inactivated hepatitis A&B represented 13.6% and 8.6% in 2015 and 2014, respectively. We do not accept returns for hepatitis products sold under the Expanded
Program on Immunization and exports, as such no sales returns are estimated for these sales. The product return provision for seasonal influenza vaccines is
estimated based on actual sales returns and expected sales returns up to the end of the flu season because we generally accept returns before the end of the flu
season. As of December 31, 2015, the sales return provision for seasonal influenza vaccine returns was approximately $1.5 million ($1.3 million as of
December 31, 2014).
Revenue for animal and mumps vaccines without a right of return provided to customers is recognized when delivery has occurred. Revenue for animal and
mumps vaccines with a right of return provided to customers is recognized when payments are collected from customers as we currently do not have sufficient
historical data to estimate returns for these products.
Deferred revenue is generally relating to government stockpiling programs and advances received from customers. For government stockpiling programs of
H1N1 and H5N1 vaccines, we generally obtain purchase authorizations from the government for a specified amount of products at a specified price and no
rights of return are provided. Revenue is recognized when the government takes delivery of the products. If the products expire prior to delivery, these expired
products are recognized as revenue once cash is received and the products have expired and passed government inspection.
Allowance for Doubtful Accounts
We extend unsecured credit to our customers in the ordinary course of business but mitigate the associated risks by performing credit checks and actively
pursuing past due accounts. An allowance for doubtful accounts is established and recorded based on management’s assessment of the credit history with the
customer and current relationships with them.
We also maintain an allowance for doubtful accounts for estimated losses based on our assessment of the collectability of specific customer accounts and the
aging of the accounts receivable. We analyze accounts receivable and historical bad debts, customer concentrations, customer solvency, current economic and
geographic trends, and changes in customer payment terms and practices when evaluating the adequacy of our current and future allowance. In circumstances
where we are aware of a specific customer’s inability to meet its financial obligations to us, a specific allowance for bad debt is estimated and recorded, which
reduces the recognized receivable to the estimated amount we believe will ultimately be collected. We monitor and analyze the accuracy of the allowance for
doubtful accounts estimate by reviewing past collectability and adjust it for future expectations to determine the adequacy of our current and future allowance.
Our reserve levels have generally been sufficient to cover credit losses. As of December 31, 2015, we provided 100% (100% as of December 31, 2014)
allowance for accounts receivable aged more than four years, approximately 71.3% (100% as of December 31,2014) allowance for accounts receivable aged
between three year and four years, approximately 38.6% (56.3% as of December 31,2014) allowance for accounts receivable aged between two year and three
years, approximately 13.6% (18.5% as of December 31,2014) allowance for accounts receivable aged between one year and two years, and approximately 1.4%
(1.8% as of December 31,2014) allowance for accounts receivable aged less than one year. For the year ended December 31, 2015, we changed our estimates of
the allowance for doubtful accounts due to an improved historical trend of collecting accounts aged three years or more. The change in estimate resulted in an
increase to income from continuing operations and net income attributable to shareholders of Sinovac by $0.4 million and $0.3 million, respectively. In addition,
basic and diluted earnings per share increased by $0.00 and $0.00, respectively.
51
Our allowance for doubtful accounts as of December 31, 2015 was $2.4 million, compared to $2.6 million as of December 31, 2014. If the financial condition of
our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required. Bad debt recovery was
$49,000 for the year ended December 31, 2015 as compared with $0.3 million expense for the year ended December 31, 2014.
Inventory Provision
We write off all the unsold seasonal influenza vaccines before the end of the flu season at the end of the fiscal year. In addition, we estimate an inventory
provision for existing Healive, Bilive, and Mumps products in inventories after considering the sales forecasts, the conditions of the raw material inventory, as
well as the expiration dates of these products. The inventory provision in 2015, 2014 and 2013 was $1.8 million, $1.0 million and $1.0 million, respectively.
Impairment of Long-Lived Assets
Long-lived assets, including intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that
the carrying value of an asset group may not be recoverable from the future undiscounted net cash flows expected to be generated by the asset group. An asset
group is identified as assets at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets. If the asset group is
not fully recoverable, an impairment loss would be recognized for the difference between the carrying value of the asset group and its estimated fair value,
based on the discounted net future cash flows or other appropriate methods, such as comparable market values. We use estimates and judgments in its
impairment tests and the timing and amount of impairment charges could be materially different if different estimates or judgments are utilized. We recorded
impairment charges on long-lived assets of nil in 2015 and 2014, as compared with $57,000 in 2013.
Amortization of Intangible Assets
We have amortized the value of intangible assets, being licenses, over an estimated useful life of 3 to 10 years. The estimated life of intangible assets is
inevitably subjective, however, whenever events or changes in circumstance indicates the carrying value may not be recoverable or, at least once per year, we
evaluate impairment and reevaluate the market opportunities for the intangible assets’ products and determine whether the remaining useful life estimate is still
reasonable. In 2015, 2014 and 2013, there was no impairment of intangible assets.
The following table shows the effect of a change in the estimated useful life of licenses and permits of 10% for 2015:
(in thousands, except for per share data)
Useful life
Amortization expense
(Loss) for the year
(Loss) per share
Changes from
reported Amount Based on
Hypothetical 10% Decrease
in Useful Life
9/2.7 years
As Reported
10/3 years
Changes from
reported amount based on
Hypothetical 10%
Increase in Useful Life
11/3.3 years
$
$
$
391
(1,131)
(0.02)
$
$
$
352 $
(1,074) $
(0.02) $
320
(1,042)
(0.02)
Given the nature of estimating the useful life of long-lived assets, it is not yet possible to provide a meaningful assessment of historical accuracy of the useful
life estimates employed. It is very likely that the useful life of the licenses and permits will be different from the estimate employed, and the changes could be
material. Changes in the estimated life of the licenses will not have a bearing on the total amount charged to operations over the life of the assets, but could
change the results of operations and financial position in any given period.
52
Income Tax Valuation Allowance
In 2015, we recorded $2.6 million of current deferred income tax assets and $0.6 million in non-current deferred income tax assets based on the difference in
timing of certain deductions for income tax and accounting purposes. We evaluate our valuation allowance requirements at each reporting period by reviewing
all available evidence, both positive and negative, and considering whether, based on the weight of that evidence, a valuation allowance is needed. When a
change in circumstances causes a change in management’s judgment about the reliability of deferred tax assets, the impact of the change on the valuation
allowance is generally reflected in income from operations. The future realization of the tax benefit of an existing deductible temporary difference ultimately
depends on the existence of sufficient taxable income of the appropriate character within the carry forward period available under applicable tax law.
Recently Issued Accounting Standards
In May 2014, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with
Customers (Topic 606). Where a single, global revenue recognition model applies to most contracts with customers. Revenue will be recognized in a manner
that depicts the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled, subject to certain
limitations. In August 2015, the FASB issued ASU 2015-14, where the effective date of ASU 2014-09 was extended to annual periods beginning after
December 15, 2018. We are currently evaluating the impact on our consolidated financial statements of adopting this standard.
In August 2014, the FASB issued ASU No. 2014-15, Going Concern. Our management will be required to evaluate whether there is substantial doubt about our
ability to continue as a going concern and, if so, disclose that fact. Our management will also be required to evaluate and disclose whether our plans alleviate
that doubt. The guidance is effective for annual periods beginning after December 15, 2016. Early adoption is permitted. We will adopt ASU 2014-15 on
January 1, 2017, and we do not expect the adoption of this standard will have a material impact on our consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30) (“ASU 2015-03”). The guidance would require that debt
issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of debt liability,
consistent with debt discounts or premiums, rather than an asset. ASU 2015-03 is effective for annual reporting periods beginning after December 15, 2015,
including interim periods within that reporting period. Early adoption is permitted. We are currently evaluating the impact, if any, of the adoption of ASU 2015-
03 on our consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17 (“ASU 2015-17”), Income Taxes. To simplify the presentation of deferred income taxes, ASU 2015-17
requires that deferred tax liabilities and assets be classified as non-current in a classified statement of financial position, applicable to all entities that present a
classified statement of financial position. The guidance is effective for annual periods beginning after December 15, 2016. Early adoption is permitted. While
we are still evaluating the impact on our consolidated financial statements of adopting this standard, we do not believe that the adoption of this guidance will
have a material impact on our consolidated financial statements.
53
In January 2016, the FASB issued ASU No. 2016-01 (“ASU 2016-01”), Financial Instruments. ASU 2016-01 requires separate presentation of financial assets
and financial liabilities by measurement category and form of financial asset on the balance sheet or in the accompanying notes to the financial statements. That
presentation provides financial statement users with more decision-useful information about an entity’s involvement in financial instruments. The guidance is
effective for annual periods beginning after December 15, 2017. Early adoption is permitted. We are currently evaluating the impact on our consolidated
financial statements of adopting this standard.
In February 2016, the FASB issued ASU No. 2016-02 (“ASU 2016-02”), Leases. ASU 2016-02 requires recognition of lease assets and lease liabilities by
lessees for those leases classified as operating leases. The guidance is effective for annual periods beginning after December 15, 2018. Early adoption is
permitted. We are currently evaluating the impact on our consolidated financial statements of adopting this standard.
In March 2016, the FASB issued ASU No. 2016-09 (“ASU 2016-09”), Compensation – Stock Compensation. Under ASU 2016-09, we can make an entity-wide
accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures when they occur. The guidance is effective
for annual periods beginning after December 15, 2016. Early adoption is permitted. We are currently evaluating the impact on our consolidated financial
statements of adopting this standard.
RESULTS OF OPERATIONS
Consolidated statements of comprehensive income (loss) data
Sales
Cost of sales(1)
Gross profit
Operating expenses:
Selling, general and administrative expenses(1)
Provision (recovery) for doubtful accounts
Research and development expenses(1)
Loss on disposal and impairment of property, plant and equipment
Government grants recognized in income
Total operating expenses
Operating income
Interest and financing expenses
Interest income
Other income
Income from continuing operations before income taxes
Income tax benefit (expenses)
Income from continuing operations
Loss from discontinued operations, net of tax nil
Net income (loss)
Less: (income) attributable to non-controlling interests
Net income (loss) attributable to shareholders of Sinovac
Comprehensive income (loss)
Less: comprehensive (income) attributable to non-controlling interests
Comprehensive income (loss) attributable to shareholders of Sinovac
Year ended December 31,
2015
2013
(in thousands except share and per share data)
2014
$
$
$
67,414
18,425
48,989
37,436
(49)
9,490
26
(1,637)
45,266
3,723
(1,920)
1,155
73
3,031
(2,516)
515
(728)
(213)
(861)
(1,074)
(4,688)
(298)
(4,986)
$
62,932
15,476
47,456
34,166
329
10,934
74
(104)
45,399
2,057
(3,407)
2,684
1,312
2,646
(1,458)
1,188
(1,524)
(336)
(515)
(851)
(2,763)
(207)
(2,970)
$
$
71,774
20,505
51,269
33,611
(504)
8,128
88
-
41,323
9,946
(3,031)
2,167
329
9,411
2,225
11,636
(1,266)
10,370
(2,928)
7,442
13,056
(3,244)
9,812
(1) Includes stock-based compensation of $1.0 million, $0.3 million and $0.3 million in 2015, 2014 and 2013, respectively.
54
Sales
Revenues from sales represent: (1) the invoiced value of goods, net of value added taxes, and sales returns. See “Item 5. Operating and Financial Review and
Prospects — A. Operating Results — Taxes and incentives.” We recognize revenues at the time when our products are delivered, persuasive evidence of an
arrangement exists, the price is fixed and determinable and there is reasonable assurance of collection of the sales proceeds; and (2) the value of goods produced
for government stockpiling program. We recognize revenues from the sales of products to the government stockpiling program when cash has been received and
the products have expired and passed government inspection or are delivered per government instruction.
Our revenues, growth and results of operations depend on several factors, including the level of acceptance of our products among doctors, hospitals and
vaccinees, and our ability to maintain or increase prices for our products at levels that provide favorable margins. The level of acceptance among doctors,
hospitals and vaccines is influenced by the performance, promotion and academic research, and pricing of our products.
We market and sell our vaccine products primarily through various provincial and municipal CDCs. We enter into sales agreements with CDCs each time a
CDC places a purchase order. Pursuant to these sales agreements, CDCs typically agree not to re-sell our products to regions outside the territory the pertinent
CDC covers administratively. Since hepatitis A vaccines were included into government sponsored expended immunization program in 2007, we have actively
participated in the tender and bidding organized by various provincial CDCs. We enter into sales agreements with the CDCs when we win a bid.
Pricing
In the private market, we set our price based on our production cost, the price of competitive products and acceptance level of CDC and vaccinees. We also
adjust our product price according to changes in the external environment to balance sales volume and gross profit, and ultimately to maximize the sales profit
margins.
In the public market, the government purchases vaccines for EPI market by issuing government tenders. During the evaluation process, price is a key factor
which impacts the result of the tender. Therefore, we need to price our products competitively to win the tender. We believe that our emphasis on product
quality is an advantage and increases our competitiveness.
Cost of sales
Our cost of sales primarily consists of material, direct labor and production overheads. Depreciation of property, plant and equipment attributable to
manufacturing activities and license amortization are capitalized as part of inventory, and expensed as cost of sales when product is sold. Cost of goods sold in
2015, 2014 and 2013 amounted to $18.4 million, $15.5 million and $20.5 million, respectively, of which idle capacity amounted to $2.2 million, $1.8 million
and $1.8 million, respectively. We produce our products and conduct the final product packaging in-house.
Our production capacity has not been fully utilized. If we successfully commercialized new products and increase sales of existing products, we expect the unit
production cost to decrease.
Selling, general and administrative expense
Selling and marketing expenses consist primarily of salaries and related expenses for personnel engaged in sales, marketing and customer support functions and
costs associated with marketing activities and shipping. The selling expense in 2015 was $19.5 million, representing 29.0% of total sales revenue of 2015,
which is a 9.5% increase compared to 2014. Going forward, we expect to maintain the selling expense as a percentage of our revenue generated by our existing
products, but we expect to increase spending on newly commercialized product(s).
General and administrative expense consists primarily of compensation for employees in executive and operational functions, including finance and accounting,
business development, and human resources. Other significant costs include facilities costs, stock-based compensation and professional fees for accounting and
legal services.
55
Research and development expenses
Our research and development expenses consist primarily of:
salaries and related expenses for personnel;
fees paid to consultants and clinical research organizations in conjunction with their independent monitoring of our clinical trials and acquiring and
evaluating data in conjunction with our clinical trials;
consulting fees paid to third parties in connection with other aspects of our product development efforts;
costs of materials used in research and development;
depreciation of facilities and equipment used to develop our products; and
technology license fees and milestone payments paid to third parties before a product receives regulatory approval.
We expense both internal and external research and development costs as incurred, other than those capital expenditures that have alternative future uses, such
as the build-out of our plant, or license fees and milestone payments made to third parties after regulatory approval is received. We expect our research and
development costs will continue to be substantial and that they will increase as we advance our current portfolio of product candidates through clinical trials and
move other product candidates into pre-clinical and clinical trials.
Taxes and incentives
Sinovac Beijing, Tangshan Yian, Sinovac R&D, Sinovac Dalian and Sinovac Biomed are subject to income taxes in China on their taxable income calculated at
a tax rate in accordance with the relevant income tax laws and regulations. Income tax returns filed by us and our active subsidiaries that are subject to
examination are Sinovac Beijing and Tangshan Yian for the years since 2005, Sinovac R&D and Sinovac Dalian for the years since 2010, and Sinovac Biomed
for 2015.
Effective from January 1, 2008, the PRC’s statutory enterprise income tax rate is 25%. Our PRC subsidiaries are subject to income tax at the statutory rate of
25% except for Sinovac Beijing. Sinovac Beijing, being reconfirmed as a High and New Technology Enterprise or HNTE in 2014 for a period of three years, is
subject to a preferential income tax rate of 15% from 2014 to 2016.
We determine deferred taxes for each tax-paying entity in each tax jurisdiction. The potential tax benefits arising from the losses incurred by the subsidiaries
have been recorded in the financial statements.
We evaluate our valuation allowances requirements at each reporting period by reviewing all available evidence, both positive and negative, and considering
whether, based on the weight of that evidence, a valuation allowance is needed. When a change in circumstances causes a change in management’s judgment
about the realizability of deferred tax assets, the impact of the change on the valuation allowance is generally reflected in income from operations. The future
realization of the tax benefit of an existing deductible temporary difference ultimately depends on the existence of sufficient taxable income of the appropriate
character within the carry forward period available under applicable tax law.
The valuation allowances relating to the deductible temporary differences and the unused tax losses of Tangshan Yian, Sinovac R&D and Sinovac Dalian are
still required as realization of these elements of the potential tax benefits is still uncertain. Taking the valuation allowances into account, the potential tax
benefits arising from the deductible temporary differences and the unused tax losses of Tangshan Yian, Sinovac R&D and Sinovac Dalian effectively have not
been recorded in the financial statements. The tax losses of the PRC subsidiaries in the amount of RMB 265.0 million ($43.7 million) can be carried forward for
five consecutive years against profits starting from 2016 and will expire ranging from 2017 to 2020, if unused.
Year Ended December 31, 2015 Compared to Year Ended December 31, 2014
Sales. Total sales from continuing operations in 2015 increased by 7.1% to $67.4 million from $62.9 million in 2014. Excluding revenue recognition of Panflu
under the government stockpiling program in 2015 and 2014, regular sales of Healive, Bilive, Anflu and mumps vaccine increased by 1.3% to $63.6 million in
2015 from $62.7 million in 2014. The growth is mainly contributed by the sales of Bilive and Anflu in the private-pay market.
56
The table below sets forth a breakdown of our sales by product:
Sales
Hepatitis A vaccine
Hepatitis A&B vaccine
Influenza vaccines
Mumps vaccines
Regular sales subtotal
H5N1 vaccine
Total sales
Year ended December 31
2014
2015
(in thousands)
26,801 $
22,615
12,674
1,472
63,562
3,852
67,414 $
26,515
21,935
12,131
2,150
62,731
201
62,932
$
$
Gross Profit. Gross profit from continuing operations in 2015 increased by 3.2% to $49.0 million from $47.5 million in 2014. Gross margin percentage
decreased to 72.7% in 2015 from 75.4% in 2014. Excluding the impact of Panflu sales under the government-stockpiling program in 2015 and 2014, gross
margin decreased to 73.4% in 2015 from 75.7% in 2014. The decrease of gross margin was mainly due to a lower utilization rate of our hepatitis and influenza
vaccine production facilities and higher inventory provision of influenza and mumps vaccines in 2015.
Selling, General and Administrative Expenses..
Selling, general and administrative expenses for 2015 were $37.4 million, which was maintained at a similar level compared to $34.2 million for 2014.
We recorded total stock-based compensation of $0.6 million in 2015 compared to $0.3 million in 2014. As of December 31, 2015, we had unrecognized
compensation costs of $2.6 million. This unearned component will be recognized over a period of 52 months.
Research and Development Expenses. Research and development expenses in 2015, primarily represented expenditures on the advancement of pipeline
vaccines, including pneumococcal vaccines, sIPV and varicella vaccine, decreased to $9.5 million in 2015 from $10.9 million in 2014.
Interest and Financing Expenses. Interest and financing expense decreased by 43.6% to $1.9 million in 2015 from $3.4 million in 2014. The decrease in
interest and financing expense is primarily due to repayment of outstanding loans during 2015 compared to 2014. There were $0.1 million and $81,000 of
interest subsidies received in 2015 and 2014, respectively.
Income Taxes Expenses. Income tax expense was $2.5 million in 2015, compared to an income tax expense of $1.5 million in 2014. Prior to 2014, Sinovac
Beijing was in a cumulative tax loss position hence did not have current income tax payable. Sinovac Beijing returned to a taxable income position, hence
recorded current income tax expense of $3.0 million and $1.6 million in 2015 and in 2014, respectively.
Income from Continuing Operations. Income from continuing operations was $0.5 million, compared to an income of $1.2 million in 2014.
Loss from Discontinued Operations. Loss from discontinued operations was $0.7 million, compared to a loss of $1.5 million in 2014.
Net Loss. Net loss attributable to shareholders of Sinovac was $1.1 million in 2015, compared to a net loss of $0.9 million in 2014.
57
Year Ended December 31, 2014 Compared to Year Ended December 31, 2013
Sales. Total sales from continuing operations in 2014 decreased by 12.3% to $62.9 million from $71.8 million in 2013. Excluding revenue recognition of Panflu
under the government stockpiling program in 2014 and 2013, regular sales of Healive, Bilive, Anflu and mumps vaccine increased by 2.8% to $62.7 million in
2014 from $61.0 million in 2013. The growth is mainly contributed by the sales of Bilive in the private-pay market, as well as Healive and Anflu sales in the
public-pay market.
The table below sets forth a breakdown of our sales by product:
Sales
Hepatitis A vaccine
Hepatitis A&B vaccine
Influenza vaccines
Mumps vaccines
Regular sales subtotal
H5N1 vaccine
Total sales
Year ended December 31
2014
2013
(in thousands)
26,515 $
21,935
12,131
2,150
62,731
201
62,932 $
26,420
20,782
12,156
1,680
61,038
10,736
71,774
$
$
Gross Profit. Gross profit from continuing operations in 2014 decreased by 7.4% to $47.5 million from $51.3 million in 2013. Gross margin increased to 75.4%
in 2014 from 71.4% in 2013. Excluding the impact of Panflu sales under the government-stockpiling program in 2014 and 2013, gross margin increased to
75.7% in 2014 from 73.5% in 2013. Higher gross margin was mainly driven by increased efficiency in the manufacturing processes which resulted in lower unit
costs, as well as increased selling price of some of our products.
Selling, General and Administrative Expenses..
Selling, general and administrative expenses for 2014 were $34.2 million, which was maintained at a similar level of $33.6 million for 2013.
We recorded stock-based compensation of $0.3 million in 2014 compared to $0.3 million in 2013. As of December 31, 2014, we had unrecognized
compensation costs of $0.1 million. This unearned component was recognized over a period of 3 months in 2015.
Research and Development Expenses. Research and development expenses in 2014, which primarily represented amounts spent on the advancement of the
pipeline vaccines, including EV71 vaccine, pneumococcal vaccines, sIPV and varicella vaccine, increased to $10.9 million from $8.1 million in 2013. This
increase was attributable to the continued advancement of PPV and sIPV.
Interest and Financing Expenses. Interest and financing expense increased by 12.4% to $3.4 million in 2014 from $3.0 million in 2013. The increase in interest
and financing expense is primarily due to higher outstanding loan balances held during 2014 compared to 2013. There were $81,000 and $65,000 of interest
subsidies received in 2014 and 2013, respectively.
Income Taxes Expenses. Income tax expense was $1.5 million in 2014, compared to an income tax recovery of $2.2 million in 2013. Prior to 2014, Sinovac
Beijing was in a cumulative tax loss position hence did not have current income tax payable. In 2014, Sinovac Beijing returned to a taxable income position,
hence recorded current income tax expense of $1.6 million.
Income from Continuing Operations. Income from continuing operations was $1.2 million in 2014, compared to an income of $11.6 million in 2013.
Loss from Discontinued Operations. Loss from discontinued operations was $1.5 million in 2014, compared to a loss of $1.3 million in 2013.
58
Net Income (loss). Net loss attributable to shareholders of Sinovac was $0.9 million in 2014, compared to a net income of $7.4 million in 2013.
B. Liquidity and Capital Resources
We finance our operations primarily through short-term and long-term borrowings, proceeds from our public offering, capital raised in our private placement,
cash generated from operations and, to a lesser extent, cash from government research grants. We believe that our current cash and cash equivalents, and
anticipated cash flow will be sufficient to meet our anticipated cash needs, including our cash needs for working capital and capital expenditure, for the next 12
months. We may, however, require additional cash due to changing business conditions or other future developments, including any investments or acquisitions
we may decide to pursue. If our existing cash is insufficient to meet our requirements, we may seek to sell additional equity securities, debt securities or borrow
from banks.
Cash Flows and Working Capital
The following table sets forth a summary of our net cash flows for the periods indicated:
Net cash provided by (used in) operating activities
Net cash used in investing activities
Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents, including cash classified within
current assets held for sale
Increase (decrease) in cash and cash equivalents, including cash classified within current assets
held for sale
Less: Net increase (decrease) in cash classified within current assets held for sale
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
$
$
Operating Activities
2015
2,661
(4,515)
(24,196)
Year ended December 31,
2014
(in thousands)
$
$
(8,647)
(11,003)
5,309
(1,491)
(1,383)
(27,541)
(82)
(27,459)
91,293
63,834
$
(15,724)
(500)
(15,224)
106,517
91,293
$
2013
5,576
(5,176)
14,419
1,182
16,001
703
15,298
91,219
106,517
Net cash provided by operating activities was $2.7 million in 2015, compared to cash used in operating activities of $8.6 million in 2014. Net cash provided by
our operating activities in 2015 resulted primarily from (1) our net income from continuing operations of $0.5 million, (2) inventory provision of $1.8 million,
(3) depreciation of property, plant and equipment and amortization of licenses of $6.5 million, (4) government grants recognized in income of $1.6 million, and
(5) a decrease of deferred revenue of $3.6 million and an increase of restricted cash of $1.7 million which was pledged as collateral for an EPI sales contract.
Net cash used in operating activities was $8.6 million in 2014, compared to cash provided by operating activities of $5.6 million in 2013. Net cash used in our
operating activities in 2014 resulted primarily from (1) our net income of $1.2 million, (2) inventory provision of $1.0 million and increase of inventories of
$6.1 million, (3) depreciation of property, plant and equipment and amortization of licenses of $8.1 million, (4) an increase in accounts receivable of $9.7
million and a decrease in accounts payables and accrued liabilities of $4.0 million.
59
Investing Activities
Net cash used in investing activities was $4.5 million in 2015, compared to $11.0 million in 2014. We used less cash to acquire property, plant and equipment in
2015.
Net cash used in investing activities was $11.0 million in 2014, compared to $5.2 million in 2013. Our 2014 property, plant and equipment purchases were
higher as we acquired equipment for the pneumococcal polysaccharide and varicella vaccine production facilities.
Financing Activities
Net cash used in financing activities was $24.2 million in 2015 compared to net cash provided by financing activities of $5.3 million in 2014. In 2015, net cash
provided by our financing activities included net proceeds of $0.7 million from issuance of common shares and government funding of $0.5 million. We also
received loan proceeds of $21.3 million and made loan repayments of $46.8 million in 2015.
Net cash provided by financing activities was $5.3 million in 2014 compared to $14.4 million in 2013. In 2014, net cash provided by our financing activities
included net proceeds of $0.5 million from issuance of common shares and government grants of $3.5 million. We also received loan proceeds of $17.8 million
and made loan repayments of $16.0 million in 2014.
Accounts Receivable
Our total accounts receivable, including other receivables decreased by $1.7 million from $40.7 million as of December 31, 2014 to $39.0 million as of
December 31, 2015. Our average accounts receivable turnover time in 2015 was 239 days, as compared to 222 days in 2014.
Our maximum exposure to credit risk at the balance sheet dates relating to accounts receivables is summarized as follows:
Aging within one year, net of allowance for doubtful accounts
Aging greater than one year, net of allowance for doubtful accounts
Total trade receivable — net
Borrowings
Year ended December 31,
2015
2014
(in thousands)
34,495
3,823
38,318
$
$
35,130
4,722
39,852
$
$
As of December 31, 2015, we had $21.8 million in short-term bank loans and current-portion of long-term bank loans, offset by $63.8 million in cash and cash
equivalents, resulting in a liquid assets balance of $42.0 million, compared with $43.9 million at the end of December 31, 2014. The following tables summarize
our short-term and long-term bank borrowings as of December 31, 2015:
Type
Loan from Beijing Zhongguancun
Development Group
Amount
RMB12.0 million
($1.9 million)
Yearly Interest
Rate
0.36%
Interest
Payment
Upon Maturity
Maturity
Date
February 24,
2016
Purpose
EV71 vaccine
research
The total loan is RMB12.0 million ($1.9 million) of which RMB6.0 million ($1.0 million) was received in 2012 and the second RMB6.0 million ($1.0 million)
was received on February 25, 2013. The loan is unsecured and repayable on February 24, 2016. The fair value differential of $0.4 million (between the face
value and the fair value using the effective interest rate method at our borrowing rate of 6.9%) is recorded as a current deferred government grant as of
December 31, 2015 ($0.4 million in 2014). The loan was repaid on February 22, 2016.
60
Type
Bank loan from Bank of China
Amount
RMB5.0 million ($0.8
Bank loan from Bank of China
RMB5.0 million ($0.8
million)
million)
Yearly Interest
Rate
6.955% floating(1)
Interest
Payment
monthly
Maturity
Date
March 16, 2016
Purpose
operation
6.01% floating(2)
monthly
October 26, 2016
operation
(1) Annual interest rate at 30% above the People’s Bank of China’s prime rate for loans of one year.
(2) Annual interest rate at 166 base points above the People’s Bank of China’s prime rate for loans of one year.
On March 17, 2015, Sinovac Dalian entered into a bank loan with Bank of China in the aggregate principal amount of RMB5.0 million ($0.8 million) to finance
its working capital requirements. The loan bears interest at 30% above the prime rate of a one-year term loan published by the People’s Bank of China, at
6.955%, the interest is paid monthly. The loan was repaid on March 16, 2016. On October 26, 2015, Sinovac Dalian entered into a bank loan with Bank of
China in the aggregate principal amount of RMB5.0 million ($0.8 million) to finance its working capital requirements. The loan bears interest at 166 base points
above the prime rate of a one-year term loan published by the People’s Bank of China, at 6.01%, the interest is paid monthly, and the loan will be repaid on
October 26, 2016. Prepaid land lease payments and buildings of Sinovac Dalian with a net book value of RMB57.6 million ($8.9 million) as of December 31,
2015 are pledged as collateral.
Type
Bank loan from Bank of Beijing
Amount
RMB4.9 million
($0.8 million)
Yearly Interest
Rate
5.25%
Interest
Payment
quarterly
Maturity
Date
January 30, 2019
Purpose
construction of
the
Pneumococcal
Polysaccharide
Vaccine facilities
Sinovac Beijing entered into a new bank loan with Bank of Beijing in the aggregate principal amount of RMB48.0 million ($7.4 million) for a period from July
2015 to July 2020 for construction of the Pneumococcal polysaccharide vaccine facilities. The loan bears interest at the bank’s prime lending rate, at 5.25% per
year. Interest is payable quarterly. The loan will be due in four installments in January 2019, July 2019, January 2020 and July 2020. RMB 4.9 million ($0.8
million) was drawn in July 2015. Prepaid land lease payments and buildings of Sinovac Beijing with a net book value of RMB18.8 million ($2.9 million) as of
December 31, 2015 are pledged as collateral.
Type
Bank loan from China Construction
Bank
Amount
RMB50.0 million
($7.7 million)
Yearly Interest
Rate
5.36%
Interest
Payment
monthly
Maturity
Date
June 3, 2016
Purpose
operation
On June 4, 2015, Sinovac Beijing entered into a bank loan with China Construction Bank in the aggregate principal amount of RMB50.0 million ($7.7 million)
to finance its working capital requirements, bearing interest at 5% above the prime rate of a one-year term loan published by the People’s Bank of China and the
interest rate of current year is 5.36%. Interest is payable monthly. The loan was drawn by three installments on June 4, 2015, June 29, 2015, and August 7, 2015,
and will be due on June 3, 2016. Pursuant to the covenants set out in the agreement, the debt to total assets ratio must not be higher than 80%, the current ratio
must not be lower than 0.8, contingent liabilities must not be higher than RMB161.0 million ($24.8 million) and contingent liabilities as a percentage of total
shareholders’ equity must not be higher than 50%. We are in compliance with such covenants as of December 31, 2015. Prepaid land lease payment and
building of the Changping facilities of Sinovac Beijing with a net book value of RMB105.1 million ($16.2 million) as of December 31, 2015 are pledged as
collateral.
61
Type
Bank loan from China Merchants
Bank
Amount
RMB20.0 million
($3.1 million)
Yearly Interest
Rate
4.57%
Interest
Payment
quarterly
Maturity
Date
November 4,
2016
Purpose
Operation
Sinovac Beijing entered into a bank loan with China Merchants Bank in the aggregate principal amount of RMB20.0 million ($3.1 million) to finance its
working capital requirements, bearing interest at 5% above the prime rate of a one-year term loan published by the People’s Bank of China, at 4.57% per year.
Interest is payable quarterly. The loan was drawn on November 5, 2015, and will be due on November 4, 2016. The loan is guaranteed by an unrelated third
party, with a guarantee fee of RMB0.4 million ($62,000) over the term of the loan. Trade receivables of Sinovac Beijing with a carrying value of not lower than
RMB35.0 million ($5.4 million) as of December 31, 2015 are pledged as collateral.
Type
Bank loan from China Merchants
Bank
Amount
RMB30.0 million
($4.6 million)
Yearly Interest
Rate
5.58%
Interest
Payment
quarterly
Maturity
Date
June 28, 2016
Purpose
Operation
Sinovac Beijing entered into a bank loan with China Merchants Bank in the aggregate principal amount of RMB30.0 million ($4.6 million) to finance its
working capital requirements bearing interest at 15% above the prime rate of a one-year term loan published by the People’s Bank of China, at 5.58% per year.
Interest is payable quarterly. The loan was drawn on June 30, 2015 and will be due on June 28, 2016.
Type
Bank loan from Bank of Beijing
Amount
RMB19.0 million
($2.9 million)
Yearly Interest
Rate
4.35%
Interest
Payment
quarterly
Maturity
Date
November 29,
2016
Purpose
Operation
Sinovac Beijing entered into a bank loan with Bank of Beijing in the aggregate principal amount of RMB50.0 million ($7.7 million) to finance its working
capital requirements. The loan bears interest at 4.35% and is payable quarterly. The first RMB9.5 million ($1.5 million) was drawn on October 28, 2015 and
will be due on October 27, 2016. The second RMB9.5 million ($1.5 million) was drawn on November 30, 2015 and will be due on November 29, 2016.
Our weighted average effective interest rate on outstanding borrowings was 6.0%, 6.8% and 6.6% for the years ended December 31, 2015, 2014 and 2013,
respectively. We have not historically used, and do not expect to use in the future, any derivative financial instruments to manage our exposure to interest risk.
Restrictions on Cash Dividends
We are a holding company, and we rely in part on dividends paid by our subsidiaries, Sinovac Beijing, Sinovac Dalian, Sinovac R&D and Sinovac Biomed for
our cash needs, mainly our operating expenses. The payment of dividends in China is subject to limitations. Regulations in the PRC currently permit payment of
dividends only out of accumulated profits as determined in accordance with accounting standards and regulations in China. Our subsidiary is also required to set
aside at least a portion of its after-tax profit based on PRC accounting standards each year to fund the statutory surplus reserves. The reserves can be used to
recoup previous years’ losses, if any, and, subject to the approval of the relevant PRC government authority, may be converted into share capital in proportion to
their existing shareholdings, or by increasing the par value of the shares currently held by them. Such reserves, however, are not distributable as cash dividends.
In addition, at discretion of their board of directors, our subsidiaries may allocate a portion of its after-tax profits based on PRC accounting standards to the
employee welfare and bonus funds, which shall be utilized for collective staff benefits. In addition, if Sinovac Beijing, Sinovac Dalian, Sinovac R&D or
Sinovac Biomed incurs debt on its own behalf in the future, the instruments governing the debt may restrict the ability of one or more of our PRC subsidiaries,
as the case may be, to pay dividends or make other distributions to us.
62
The ability of our subsidiary to convert renminbi into U.S. dollars and make payments to us is subject to PRC foreign exchange regulations. Under these
regulations, the renminbi is convertible for current account items, including the distribution of dividends, interest payments, trade and service-related foreign
exchange transactions. Conversion of renminbi for capital account items, such as direct investment, loan, security investment and repatriation of investment,
however, is still subject to the approval of the SAFE. See “Item 10. Additional Information — D. Exchange Controls.”
Capital Expenditures
We made capital expenditures of $5.3 million, $10.9 million and $5.1 million in 2015, 2014 and 2013, respectively. In 2015, we made $5.3 million of payments
towards property, plant and equipment for construction of PPV and varicella production facilities. As of December 31, 2015, our commitments related to capital
expenditures of approximately $1.7 million were primarily for the construction of our PPV, sIPV and varicella production facilities. We will finance such
commitments through short-term and long-term borrowings, proceeds from our public offering in 2010 and cash generated from operations.
C. Research and Development, Patents and Licenses, Etc.
See discussions under “Item 5. Operating and Financial Review and Prospects — A. Operating Results — Research and Development Programs.”
D. Trend Information
Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events for the period from
January 1, 2015 to December 31, 2015 that are reasonably likely to have a material adverse effect on our net revenues, income, profitability, liquidity or capital
resources, or that caused the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
E. Off-Balance Sheet Arrangements
We do not, and did not, have any interest in variable interest entities or any other off-balance sheet arrangements that require disclosure.
F. Tabular Disclosure of Contractual Obligations
The following table summarizes our estimated contractual obligations and commitments as of December 31, 2015 for the periods indicated:
Debt obligations including amount owing to related party (including
interest)
R&D expenses, liabilities and commitment
Operating lease obligations
Purchase of facilities commitments
Accounts payable and accrued liabilities
Total
Payments due by period
Total
Less than
1 year
1 – 3 years
4 – 5 years
(in thousands)
More than
5 years
$
$
$
25,920
441
12,861
1,726
22,524
63,472 $
$
25,048
441
852
1,726
22,524
50,591 $
79 $
—
1,704
—
—
1,783 $
$
793
—
1,704
—
—
2,497 $
—
—
8,601
—
—
8,601
63
G. Safe Harbor
This annual report on Form 20-F contains forward-looking statements that relate to future events, including our future operating results and conditions, our
prospects and our future financial performance and condition, all of which are largely based on our current expectations and projections. The forward-looking
statements are contained principally in the sections entitled “Item 3. Key Information — D. Risk Factors,” “Item 4. Information on the Company” and “Item 5.
Operating and Financial Review and Prospects.” These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform
Act of 1995. You can identify these forward-looking statements by terminology such as “may,” “will,” “expect,” “anticipate,” “future,” “intend,” “plan,”
“believe,” “estimate,” “is/are likely to” or other and similar expressions. Forward-looking statements involve inherent risks and uncertainties. A number of
factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following:
our ability to maximize sales of our existing products within the Chinese market;
our ability to develop new vaccines;
our ability to improve our existing vaccines and lower our production costs;
our ability to expand our manufacturing facilities to meet need of the growing Chinese market and other geographic markets;
our ability to acquire new technologies and products;
uncertainties in and the timeliness of obtaining necessary governmental approvals and licenses for marketing and sale of our vaccines in certain
overseas markets;
our ability to compete successfully against our competitors;
risks associated with our corporate structure and the regulatory environment in China; and
other risks outlined in our filings with the Securities and Exchange Commission, or the SEC, including this annual report on Form 20-F.
The forward-looking statements made in this annual report on Form 20-F relate only to events or information as of the date on which the statements are made in
this annual report on Form 20-F. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as
a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You
should read this annual report on Form 20-F completely and with the understanding that our actual future results may be materially different from what we
expect.
ITEM 6.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The following table sets forth information regarding our directors and executive officers as of the date of this annual report:
Directors and Executive Officers
Weidong Yin
Simon Anderson(1) (2) (3)
Yuk Lam Lo(1) (2) (3)
Kenneth Lee(2) (3)
Meng Mei(1) (2) (3)
Nan Wang
Ming Xia
Qiang Gao
Jing Li
Position/Title
Chairman, President, Chief Executive Officer
Independent Director
Independent Director
Independent Director
Independent Director
Chief Financial Officer, Vice President
Vice President, Sales and Marketing
Vice President, Research and Development
Vice President, Quality and Production
Age
52
54
67
48
61
49
42
39
41
64
(1) Member of the audit committee.
(2) Member of the nominating and corporate governance committee.
(3) Member of the compensation committee.
Mr. Weidong Yin has served as our chairman, president, chief executive officer and secretary since September 2003. Mr. Yin is also the general manager of
Sinovac Biotech and the chairman of Sinovac Hong Kong and Sinovac Dalian. He is the former general manager of Tangshan Yian Bioengineering Co., Ltd.,
and he previously worked as a medical doctor in infectious disease at the China Center for Disease Control and Prevention, Tangshan City, Hebei province. Mr.
Yin has been dedicated to hepatitis research for over 20 years and was instrumental in the development of Healive. In addition, Mr. Yin has been appointed as
the principal investigator by the Chinese Ministry of Science and Technology for many key governmental R&D programs such as Inactivated Hepatitis A
Vaccine R&D, Inactivated SARS Vaccine R&D and New Human Influenza Vaccine (H5N1) R&D. He is also the president of Zhongguancun Listed Companies
Association. He obtained his MBA from the National University of Singapore.
Mr. Simon Anderson has served as an independent director of our company since July 2004. Mr. Anderson is a member of our audit, compensation, and
corporate governance and nominating committees. Mr. Anderson provides consulting expertise in the areas of regulatory compliance, exchange listings and
financial operations. He was admitted as a member of the Institute of Chartered Professional Accountants in British Columbia in 1986. Mr. Anderson serves as
chief financial officer of companies listed on North American stock exchanges, including IBC Advanced Alloys Corp., which manufactures and processes
alloys at its U.S. plants. Mr. Anderson also serves as a director of Simba Gold Corp., a gold exploration company.
Mr. Yuk Lam Lo has served as an independent director of our company since March 2006. Mr. Lo is a member of the audit, compensation and corporate
governance and nominating committees. Currently Mr. Lo is serving as the Chairman of the Advisory Council for Food Safety of the Food and Health Bureau
HKSAR, an Executive Committee Member of the Chinese Manufacturers’ Association of Hong Kong (CMA) and Chairman of the Education Committee of
CMA. Mr. Lo is also the Honorary Founding Chairman of Hong Kong Bio-Organization. In the educational area, Mr. Lo has been elected an Honorary Fellow
of the Hong Kong University of Science and Technology. He is an Honorary Chairman of Hong Kong Food Safety Association, Adjunct Professor of the
Chinese University of Hong Kong and Honorary Professor of several universities in China. Mr. Lo was heavily involved in several committees of the HKSAR
Government. He had been appointed as Director of the Hong Kong Applied R&D Fund Co. Ltd., Chairman of the Biotechnology Committee of the Hong Kong
Industry & Technology Development Council, and Chairman of Biotechnology Projects Vetting Committee of the Innovation and Technology Fund, HKSAR.
In China, Mr. Lo is a Member of Chinese People’s Political Consultative Conference in Jilin province, and a Consultant of the Centre for Disease Control and
Prevention of China. In the business sector, he is an Independent Director of Luye Pharma Group Limited (2186.HK) and CSPC Pharmaceutical Group Limited
(1093.HK).
Mr. Kenneth Lee is an independent director of Sinovac. He has served on our board of directors since May 2011. In July 2012, the board appointed him as a
member of the compensation committee and corporate governance and nominating committee. Mr. Lee is a partner at SAIF Partners. SAIF Partners IV L.P. is
currently the largest shareholder of Sinovac. Mr. Lee has more than 20 years of experience across private equity investments, corporate finance, and business
development in China. He is a non-executive director on the boards of four Chinese portfolio companies publicly listed on the stock exchanges in the United
States and Hong Kong and a board director for four other private Chinese companies backed by SAIF Partners. Mr. Lee is a graduate of Amherst College.
Mr. Meng Mei has served as an independent director of our company since March 2012. Mr. Mei is the chairman of compensation committee, and member of
the audit and corporate governance and nominating committees. Mr. Mei founded TusPark, a science park established by Tsinghua University in 1994, to
incubate high growth companies. He has been the director of TusPark’s development center since its inception. Mr. Mei is also the Chairman of TusHoldings
Co., Ltd., which is engaged in the development, construction, and management of TusPark and is providing services to enterprises based in TusPark.
TusHoldings Co., Ltd. is also involved in venture capital investments in China. Mr. Mei sits on the judging expert panel of China’s National Science &
Technology Award. He has developed courses on entrepreneurship and new venture formation as a Tsinghua University professor and an entrepreneur. Mr. Mei
holds a bachelor’s degree in automation from Tsinghua University, PRC.
Ms. Nan Wang has served as our chief financial officer since June 2013. Ms. Wang served as the vice president of Sinovac Beijing from 2001 to 2013 where she
oversaw business development, investment, and clinical research. From 1988 to 1993, Ms. Wang was a researcher in biology at the Life Science College of
Peking University, PRC. From 1993 to 2001, she worked as a manager at SinoBioway. Ms. Wang received her bachelor’s degree in biology from Peking
University and her master’s degree from University of International Business and Economics, PRC. Ms. Wang also received a diploma in financial management
from Beijing College for Entrepreneurs, PRC in 2003.
65
Mr. Ming Xia has served as our vice president since April 2016. Mr. Xia has served as the vice president of Sinovac Beijing since 2011 where he oversees sales
and marketing departments. Mr. Xia has over 15 years’ experience in vaccine sales and marketing in China. He joined Sinovac in 2002 and has served as
Regional Sales Manager, National Sales Manager and Sales Director at Sinovac. Mr. Xia obtained his bachelor degrees in Biochemistry at Anhui University and
in International Trade at Shanghai Institute of Foreign Trade. Mr. Xia has made significant contributions to our sales revenue growth in previous years with
outstanding leadership and performance results. He kept his top record of generating sales revenue for many years after joining Sinovac. He is a leader with
creativity and developed the sales strategy for our existing products. Mr. Ming Xia organized the reform on sales and marketing strategy to meet the change of
the market situation.
Mr. Qiang Gao has served as our vice president since April 2016. Mr. Gao joined Sinovac Beijing in 2002 and has served as quality control manager, quality
assurance manager, R&D manager and R&D director at Sinovac Beijing in the past years, and the general manager of Sinovac R&D since 2010. He is
responsible for developing our new vaccine products, including EV71 vaccine. Mr. Gao received a master’s degree and a bachelor’s degree in microbiology
from the University of Agriculture, PRC.
Ms. Jing Li has served as our vice president since April 2016. Ms. Li was named as quality person of Sinovac Beijing in March 2015. Since she joined Sinovac
Beijing in 2003, she has worked in different roles in production and quality function, including quality assurance vice manager, department manager of hepatitis
A vaccine production and director of vaccine production at Sinovac Beijing. Ms. Li is also in charge of the production of our EV71 vaccine. Ms. Li received a
master’s degree in physiology from the University of Agriculture, PRC.
B. Compensation
In 2015, the aggregate cash compensation paid to our directors and executive officers was approximately $1.4 million. No executive officer is entitled to any
severance benefits upon termination of his or her employment with our company. The bonus plan of the executive offers is made based on our annual
performance in different functions and the respective key result areas of these functional teams. Each vice president’s bonus is determined based on the key
corporate development objectives and key performance index set by the compensation committee and approved by the board at the beginning of the year. The
bonus payoff plan is approved by the board.
Our shareholders have authorized the board of directors to administer two share incentive plans which in aggregate provide for the issuance of up to 9,000,000
shares of common stock, including 5,000,000 shares reserved under the 2003 Stock Option Plan and 4,000,000 shares reserved under 2012 Share Incentive Plan.
The following tables summarize, as of March 31, 2016, the outstanding options and regular shares that we granted to several of our directors, executive officers,
principal shareholders and to other individuals as a group, all of which were made under our 2003 Stock Option Plan and 2012 Share Incentive Plan,
respectively.
Name
Ming Xia
Other individual as a group
Total outstanding options
2003 Option Plan
Number of
Options
Exercise
Price
Grant Date
2.37/share
December 26, 2011
2.37/share
21,500
97,500
119,000
$
$
66
Expiration Date
December 25, 2017
2012 Share Incentive Plan
Name
Restricted
Shares
Number of
Options
Exercise
Price
($/Share)
Grant Date
Expiration
Date
Weidong Yin
Simon Anderson
Yuk Lam Lo
Meng Mei
Kenneth Lee
Nan Wang
Ming Xia
Others as a group
Subtotal
* Weighted Average Exercise Price
0
0
0
0
0
60,000
60,000
609,000
729,000
150,000
40,000
40,000
40,000
40,000
90,000
90,000
851,000
1,341,000
May 1, 2015 April 30, 2023
4.98
May 1, 2015 April 30, 2023
4.98
May 1, 2015 April 30, 2023
4.98
May 1, 2015 April 30, 2023
4.98
May 1, 2015 April 30, 2023
4.98
May 1, 2015 April 30, 2023
4.98
4.98
May 1, 2015 April 30, 2023
4.98 May 1, 2015 April 30, 2023
Total
150,000
40,000
40,000
40,000
40,000
150,000
150,000
1,460,000
2,070,000
We have not set aside or accrued any amount of cash to provide pension, retirement or other similar benefits to our officers and directors. Our PRC subsidiaries
and consolidated affiliated entities as well as their subsidiaries are required by law to make contributions equal to certain percentages of each employee’s salary
for his or her retirement benefit, medical insurance benefits, housing funds, unemployment and other statutory benefits.
2003 STOCK OPTION PLAN
Our board of directors adopted the 2003 Stock Option Plan, or the 2003 Plan, on November 1, 2003. The purpose of the plan is to attract and retain the best
available personnel for positions of substantial responsibility, provide additional incentive to employees, directors and consultants and promote the success of
our business. Our board of directors believes that our company’s long-term success is dependent upon our ability to attract and retain superior individuals who,
by virtue of their ability, experience and qualifications, make important contributions to our business.
Set forth below is a summary of the principal terms of the 2003 Plan.
Size of plan. We have reserved an aggregate of 5,000,000 of our common shares for issuance under the 2003 Plan. As of December 31, 2015, options
to purchase an aggregate of 904,400 of our common shares were issued and outstanding and an aggregate of 4,017,800 common shares have been
issued pursuant to options issued under the 2003 Plan.
Administration. The 2003 Plan is administered by our board of directors. The board will determine the provisions, terms and conditions of each option
grant, including without limitation the option vesting schedule or exercise installment, the option exercise price, payment contingencies and satisfaction
of any performance criteria.
Vesting schedule. The vesting schedules of options granted will be specified in the applicable option agreements.
Option agreement. Options granted under the 2003 Plan are evidenced by option agreements that contain, among other things, provisions concerning
exercisability and forfeiture upon termination of employment or consulting arrangements by reason of death or otherwise, as determined by our board.
In addition, the option agreement also provides no option shares will be issued under the plan unless the Securities Act has been fully complied with.
Option term. The term of options granted under the 2003 Plan may not exceed ten years from the date of grant.
Termination of options. Where the option agreement permits the exercise of the options granted for a certain period of time following the recipient’s
termination of services with us, the options will terminate to the extent any options are not exercised or purchased on the last day of the specified
period or the last day of the original term of the options, whichever occurs first.
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Change of control. If a third-party acquires us through the purchase of all or substantially all of our assets, a merger or other business combination, all
outstanding stock options will become fully vested and exercisable immediately prior to such transaction.
Termination of plans. Unless terminated earlier, the Plan will expire in 2023. Our board of directors has the authority to terminate the 2003 Plan prior
to the expiry of the plan provided that such early termination shall not affect the options then outstanding under the plan.
2012 SHARE INCENTIVE PLAN
In August 2012, our shareholders adopted a 2012 Share Incentive Plan, or the 2012 Plan. The maximum aggregate number of common shares which may be
issued pursuant to all awards under the 2012 Plan is 4,000,000 shares. The following paragraphs describe the principal terms of the 2012 Plan.
Types of Awards
The types of awards we may grant under the plan include the options to purchase our common shares at a specified price and in a specified period determined by
our board. Under the 2012 Plan, we may also grant awards of our (1) restricted shares, (2) restricted share units, (3) dividend equivalents, (4) deferred shares,
(5) share payments and (6) share appreciation rights under the terms and conditions determined by our board of directors.
Eligibility
We may grant awards to the directors, officers, advisors and employees of us and our wholly owned subsidiaries and any entity which may thereafter be
established.
Plan Administration
Our board of directors will administer the plan. The board will determine the terms and conditions of each grant, including but not limited to, the exercise, grant
or purchase prices, any reload provision, any restrictions or limitations on the awards, vesting schedules, restrictions on the exercisability of the awards, any
accelerations or waivers, and any provision related to non-competition and recapture of gain on the awards.
Award Agreement
Awards granted under the plan will be evidenced by an award agreement that will set forth the terms, conditions and limitations for each award. The award
agreement should be signed by the employee and a director or an officer of us. Share awards may be evidenced by way of an issuance of certificates or book
entries with appropriate legends. The certificates and book entry procedures may be subject to counsels’ advice, stop-transfer orders or other conditions or
restrictions where the plan administrator deems necessary to comply with the required laws and regulations.
Vesting
The 2012 Plan provides that the administrator may set the period during which an option or a share appreciation right can be exercised and may determine that
an option or a share appreciation right may not be exercised for a specified period after it is granted. Such vesting can be based on criteria selected by the
administrator. At any time after the grant of an option or a share appreciation right, the administrator may, in its sole discretion and subject to the terms and
conditions it determines, accelerate the period during which an option or a share appreciation right vests. No portion of an option or a share appreciation right
exercisable at the termination of service of an option or a share appreciation right holder with our company or subsidiaries can become exercisable afterwards,
unless otherwise provided by the administrator.
Exercise Price and Term of Awards
The exercise price per share of options granted under the 2012 Plan is determined by the plan administrator in the award agreement. The price may be fixed or
variable related to the fair market value of our ordinary shares. The term of any option granted should not exceed ten years. However, in the case where our
incentive option is granted to an individual who, at the date of grant, owns more than ten percent of the total voting power of all classes of our shares, the price
granted shall not be less than 110% of the fair market value on the date of grant and the option is exercisable for no more than five years from the date of grant.
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For common share awards granted under the 2012 Plan, namely (1) restricted shares, (2) restricted share units, (3) dividend equivalents, (4) deferred shares, and
(5) share payments, the consideration shall not be less than the par value of the shares purchased. The terms of the share awards are set by the plan administrator
in its sole discretion.
The exercise price of share appreciation right under the 2012 Plan is determined by the plan administrator and set forth in the award agreement which may be a
fixed or variable price related to the fair market value of the shares. The term of the share appreciation right will not exceed ten years.
The approval of shareholders is required for downward adjustment of the exercise prices of options or share appreciation rights. A downward adjustment of the
exercise prices of options or share appreciation rights means (i) lowering the exercise price of outstanding options or share appreciation rights, or (ii) cancelling
outstanding options or share appreciation rights in exchange for cash, other awards, or options or share appreciation rights with an exercise price that is less than
the exercise price of the original options or share appreciation rights.
Transfer Restrictions
The awards granted under the 2012 Plan may not be sold, pledged, assigned or transferred other than by will or the laws of descent and distribution or, subject to
the consent of the plan administrator, as required under the applicable laws.
Amendments or Termination
The 2012 Plan provides that in the event of any changes affecting our common shares or our share price, the plan administrator can make proportionate and
equitable adjustments to reflect such changes. Upon or in anticipation of a corporate transaction, including acquisition, disposal of substantially all or all assets,
reverse takeover, dissolution, the plan administrator should in its discretion provide for replacement or assumption of such award. In the event of other changes,
the board of directors should in its discretion make adjustments in the number and class of shares subject to awards outstanding on the date of such change to
prevent dilution or enlargement of rights. The 2012 Plan will expire and no further awards may be granted after the tenth anniversary of the date the plan was
adopted.
C. Board Practices
Board of Directors
Our Articles of Incorporation prescribe that we should have a minimum of one and a maximum of 15 directors. Currently, our board of directors comprises five
board members, four of whom are independent. A director is not required to hold any shares in the company by way of qualification. A director may vote with
respect to any contract, proposed contract or arrangement in which he is materially interested provided that such director must disclose his interest in the
contract or arrangement. There is no age limit requirement for directors. Under Antigua law, our directors have a duty of loyalty to act honestly, in good faith
and with a view to our best interests. Our directors also have a duty to exercise the skill they actually possess and such care and diligence that a reasonably
prudent person would exercise in comparable circumstances. In fulfilling their duty of care to us, our directors must ensure compliance with our Articles of
Incorporation and By-laws, as amended and re-stated from time to time. A shareholder has the right to seek damages if a duty owed by our directors is breached.
The functions and powers of our board of directors include, among others:
convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings;
declaring dividends and distributions;
appointing officers and determining the term of office of officers;
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exercising the borrowing powers of our company and mortgaging the property of our company; and
approving the transfer of shares of our company, including the registering of such shares in our share register.
Terms of Directors and Executive Officers
Our officers are elected by and serve at the discretion of the board of directors. Our directors are not subject to a term of office and hold office until a successor
is elected at the next annual shareholders’ meeting. A director will be removed from office automatically if, among other things, the director (i) becomes
bankrupt or makes any arrangement or composition with his creditors or (ii) dies or is found by our company to be or becomes of unsound mind. None of our
directors has a service contract with us or any of our subsidiaries providing for benefits upon termination of employment.
Committees of the Board of Directors
Our board of directors has established an audit committee, a compensation committee and a corporate governance and nominating committee.
Audit Committee
Our audit committee consists of Messrs. Simon Anderson, Yuk Lam Lo and Meng Mei, and is chaired by Simon Anderson, all of whom satisfy the
“independence” requirements of Rule 5605 of the NASDAQ Listing Rules and Rule 10A-3 under the Securities Exchange Act of 1934. The audit committee
oversees our accounting and financial reporting processes and the audits of the financial statements of our company. The audit committee is responsible for,
among other things:
selecting our independent auditors and pre-approving all auditing and non-auditing services permitted to be performed by our independent auditors;
reviewing with our independent auditors any audit problems or difficulties and management’s response;
reviewing and approving all proposed related party transactions, as defined in Item 404 of Regulation S-K under the Securities Act;
discussing the annual audited financial statements with management and our independent auditors;
reviewing major issues as to the adequacy of our internal controls and any special audit steps adopted in light of material control deficiencies;
annually reviewing and reassessing the adequacy of our audit committee charter;
such other matters that are specifically delegated to our audit committee by our board of directors from time to time;
meeting separately and periodically with management and our internal and independent auditors; and
reporting regularly to the full board of directors.
In 2015, our audit committee held meetings or passed resolutions by unanimous written consent nine times.
Compensation Committee
Our compensation committee consists of Messrs. Meng Mei, Simon Anderson, Yuk Lam Lo, and Kenneth Lee, and is chaired by Mr. Meng Mei, all of whom
satisfy the “independence” requirements of Rule 5605 of the NASDAQ Listing Rules and Rule 10C-1 under the Securities Exchange Act of 1934. Our
compensation committee assists the board in reviewing and approving the compensation structure of our directors and executive officers, including all forms of
compensation to be provided to our directors and executive officers. Members of the compensation committee are not prohibited from direct involvement in
determining their own compensation. Our chief executive officer may not be present at any committee meeting during which his compensation is deliberated.
The compensation committee is responsible for, among other things:
70
approving and overseeing the compensation package for our executive officers;
reviewing and making recommendations to the board with respect to the compensation of our directors;
reviewing and approving corporate goals and objectives relevant to the compensation of our chief executive officer, evaluating the performance of our
chief executive officer in light of those goals and objectives, and setting the compensation level of our chief executive officer based on this evaluation;
and
reviewing periodically and making recommendations to the board regarding any long-term incentive compensation or equity plans, programs or similar
arrangements, annual bonuses, employee pension and welfare benefit plans.
In 2015, our compensation committee held meetings or passed resolutions by unanimous written consent three times.
Corporate Governance and Nominating Committee
Our corporate governance and nominating committee consists of Messrs. Yuk Lam Lo, Simon Anderson, Kenneth Lee and Meng Mei, and is chaired by Mr.
Yuk Lam Lo, all of whom satisfy the “independence” requirements of Rule 5605 of the NASDAQ Listing Rules. The corporate governance and nominating
committee assists the board of directors in identifying individuals qualified to become our directors and in determining the composition of the board and its
committees. The corporate governance and nominating committee is responsible for, among other things:
identifying and recommending to the board nominees for election or re-election to the board, or for appointment to fill any vacancy;
reviewing annually with the board the current composition of the board in light of the characteristics of independence, age, skills, experience and
availability of service to us;
identifying and recommending to the board the directors to serve as members of the board’s committees;
advising the board periodically with respect to significant developments in the law and practice of corporate governance as well as our compliance with
applicable laws and regulations and making recommendations to the board on all matters of corporate governance and on any corrective action to be
taken; and
monitoring compliance with our code of business conduct and ethics, including reviewing the adequacy and effectiveness of our procedures to ensure
proper compliance.
In 2015, our corporate governance and nominating committee held meetings or passed resolutions by unanimous written consent once.
Interested Transactions
A director may vote in respect of any contract or transaction in which he or she is interested, provided that the nature of the interest of any directors in such
contract or transaction is disclosed by him or her at or prior to its consideration and any vote in that matter.
Remuneration and Borrowing
The directors may determine remuneration to be paid to the directors. The compensation committee assists the directors in reviewing and approving the
compensation structure for the directors. The directors may exercise all our powers to borrow money and to mortgage or charge its undertaking, property and
uncalled capital, and to issue debentures or other securities whether outright or as security for any debt obligations of our company or of any third party.
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D. Employees
As of December 31, 2015, 2014 and 2013, we had 646, 668 and 715 full-time employees, respectively. Of our workforce as of December 31, 2015, about 140
employees are primarily engaged in research and development, 172 employees are engaged in sales and marketing, 271 employees in production related, and 61
employees in administration. As of December 31, 2015, we have a total of 111 temporary employees. We consider our relationship with our employees to be
good.
E. Share Ownership
The following table sets forth information with respect to the beneficial ownership of our common shares, as of December 31, 2015, by:
each of our directors and executive officers; and
each person/organization known to us to own beneficially more than 5% of our common shares.
The calculations in the table below are based on 56,906,561 common shares outstanding as of December 31, 2015. Beneficial ownership is determined in
accordance with the rules and regulations of the SEC. In computing the number of shares beneficially owned by a person and the percentage ownership of that
person, we have included shares that the person has the right to acquire within 60 days, including through the exercise of any option, warrant or other right or
the conversion of any other security. These shares, however, are not included in the computation of the percentage ownership of any other person.
Directors and Executive Officers:
Weidong Yin
Simon Anderson
Yuk Lam Lo
Nan Wang
Ming Xia
All directors and executive officers as a group
Principal Shareholders
SAIF Partners IV(1)
1Globe Capital LLC(2)
Wellington Management Company LLP(3)
Chiang Li Family(4)
Samuel D. Isaly(5)
Shares Beneficially Owned
%
Number
6,049,500
50,000
50,000
105,000
141,000
6,395,500
10,780,820
9,353,092
5,229,421
3,459,763
2,667,500
10.63%
*
*
*
*
11.24%
18.94%
16.44%
9.19%
6.08%
4.69%
Less than 1% of our common shares.
*
(1) According to the Amendment No. 5 to Schedule 13D filed with the SEC on February 2, 2016 by SAIF Partners IV L.P., SAIF IV GP, L.P. and SAIF IV GP
Capital Ltd.
(2) According to the Amendment No. 1 to Schedule 13G filed with the SEC on April 5, 2016.
(3) According to the Amendment No. 2 to Schedule 13G filed with the SEC on February 11, 2016 by Wellington Management Group LLP, Wellington Group
Holdings LLP, Wellington Investment Advisors Holdings LLP and Wellington Management Company LLP. Wellington Management Group LLP is a
parent holding company of certain holding companies and certain investment advisors, including Wellington Management Company LLP. Wellington
Investment Advisors Holdings LLP is owned by Wellington Group Holdings LLP. Wellington Group Holdings LLP is owned by Wellington Management
Group LLP.
(4) According to the Schedule 13G filed with the SEC on April 11, 2016.
(5) According to the Amendment No. 1 to 13G filed with the SEC on February 11, 2016, consists of (i) 1,219,500 common shares beneficially owned by
OrbiMed Advisors LLC and (ii) 1,448,000 common shares beneficially owned by OrbiMed Capital LLC. OrbiMed Advisors LLC and OrbiMed Capital
LLC are investment advisors, and Samuel D. Isaly is the control person of OrbiMed Advisors LLC and OrbiMed Capital LLC.
None of our existing shareholders has different voting rights from other shareholders. We are not aware of any arrangement that may, at a subsequent date,
result in a change of control of our company.
72
As of December 31, 2015, 56,906,561 of our common shares were issued and outstanding. Approximately 89% of the issued and outstanding shares are held by
the record shareholders in the United States.
For the options granted to our directors, officers and employees, please refer to “— B. Compensation of Directors and Executive Officers.”
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
Please refer to “Item 6. Directors, Senior Management and Employees — E. Share Ownership.”
B. Related Party Transactions
Transaction with Yuk Lam Lo
Sinovac Hong Kong is using part of the office of Mr. Yuk Lam Lo, one of our independent directors, as its office. We do not pay any rent to Mr. Yuk and only
pay our share of the utilities and property management fees, which totaled $4,000, $4,000 and $4,000 in 2013, 2014 and 2015, respectively.
Transactions with Certain Directors and Affiliates
We entered into two operating lease agreements with SinoBioway, a non-controlling shareholder of Sinovac Beijing, in 2004, to lease Sinovac Beijing’s
production plant and laboratory in Beijing with annual lease payments totaling RMB2.3 million ($0.4 million). The leases commenced on August 12, 2004 and
have a term of 20 years. One of the lease agreements was amended on August 12, 2010 to increase the rent from RMB0.5 million ($81,000) to RMB1.4 million
($0.2 million) per year.
In June 2007, we entered into another operating lease agreement with SinoBioway for an annual lease payment of RMB2.0 million ($0.3 million) to expand
Sinovac Beijing’s production plant in Beijing. The lease commenced in June 2007 and has a term of 20 years.
In September 2010, we entered into another operating lease agreement with SinoBioway for an annual lease payment of RMB1.0 million ($0.2 million) to
expand Sinovac R&D’s business. The lease commenced on September 30, 2010 and has a term of five years.
On April 8, 2013, we entered into three supplemental agreements with SinoBioway, under which the expiration date of three of the operating lease agreements
was extended to April 7, 2033.
Loan from a non-controlling shareholder
In 2011, Sinovac Dalian entered into an agreement to borrow RMB20.0 million ($3.1 million) loan from its non-controlling shareholder, Dalian Jin Gang
Group. The loan was unsecured, bearing interest at 7.2% per year. RMB4.0 million ($0.6 million) was repaid on September 25, 2014. No repayments were
made in 2015.
Share Options
See “Item 6. Directors, Senior Management and Employees — B. Compensation — 2003 Stock Option Plan” and “Item 6. Directors, Senior Management and
Employees — B. Compensation — 2012 Share Incentive Plan.”
C.
Interests of Experts and Counsel
Not applicable.
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ITEM 8.
FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
We have appended consolidated financial statements filed as part of this annual report.
Legal and Administrative Proceedings
We are not currently a party to any material litigation or other legal proceedings brought against us. We are also not aware of any legal proceedings,
investigation or claim, or other legal exposure that has a more than remote possibility of having a material adverse effect on our business, financial condition or
results of operations. We may be subject to legal proceedings, investigations and claims incidental to the conduct of our business from time to time.
Dividend Policy
We have never declared or paid any dividends, nor do we have any present plan to pay any cash dividends on our common shares in the foreseeable future. We
currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business.
Our board of directors has complete discretion on whether to pay dividends. Even if our board of directors decides to pay dividends, the form, frequency and
amount will depend upon our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other
factors that the board of directors may deem relevant. Cash dividends on our common shares, if any, will be paid in U.S. dollars.
We are a holding company, and we rely on the dividends paid by our majority-owned subsidiaries, Sinovac Beijing and Sinovac Dalian, wholly owned
subsidiaries Sinovac R&D and Sinovac Biomed through Sinovac Hong Kong, for our cash needs, including the funds necessary to pay any dividends and other
cash distributions to our shareholders, service any debt we may incur and pay our operating expenses. The payment of dividends in China is subject to
limitations. Regulations in the PRC currently permit payment of dividends by our PRC subsidiaries only out of accumulated profits as determined in accordance
with accounting standards and regulations in China. In accordance with the regulations in China, Sinovac Beijing, Sinovac Dalian, Sinovac R&D and Sinovac
Biomed are required to set aside at least 10% of its after-tax profits each year to contribute to its reserve fund until the accumulated balance of such reserve fund
reaches 50% of the registered capital of each company. Sinovac Beijing, Sinovac Dalian, Sinovac R&D and Sinovac Biomed are required to set aside, at the
discretion of their respective board of directors, a portion of its after-tax profits to their employee welfare and bonus funds.
Furthermore, pursuant to the double tax arrangement between Hong Kong and PRC, dividends paid by a foreign-invested enterprise in China to its direct
holding company in Hong Kong will be subject to withholding tax at a rate of no more than 5% (if the foreign investor owns directly at least 25% of the shares
of the foreign-invested enterprise for a period greater than 12 months), or otherwise 10%. Whether the favorable rate will be applicable to dividends received by
Sinovac Hong Kong from our PRC subsidiaries is subject to the approval of the PRC tax authorities because it is unclear whether Sinovac Hong Kong is
considered as the beneficial owner of the dividends in substance. The PRC tax authorities have discretion to assess whether a recipient of the PRC-sourced
income is only an agent or a conduit, or lacks the requisite amount of business substance, in which case the application of the tax arrangement may be denied.
This withholding tax imposed on dividends paid to us by our PRC subsidiaries would reduce our net income attributable to the shareholders. In May 2012,
Sinovac Hong Kong was granted by the local tax bureau the preferential dividend withholding tax rate of 5% on dividends declared by Sinovac Beijing for three
years from 2012 to 2014. The State Administration of Taxation has the authority to re-assess the approval of the preferential dividend withholding tax rate
granted by the local tax bureau. The preferential dividend withholding tax rate expired in 2014. The dividends received by Sinovac Hong Kong from its PRC
subsidiaries are subject to a withholding tax rate of 10%.
74
B. Significant Changes
Except as disclosed elsewhere in this annual report, we have not experienced any significant changes since the date of our audited consolidated financial
statements included in this annual report.
ITEM 9.
THE OFFER AND LISTING
A. Offer and Listing Details
The table below sets forth, for the periods indicated, the high and low trading prices on the NASDAQ Global Market and the NASDAQ Global Select Market
for our common shares.
Annual High and Low
2011
2012
2013
2014
2015
Quarterly High and Low
First quarter 2014
Second Quarter 2014
Third Quarter 2014
Fourth Quarter 2014
First Quarter 2015
Second Quarter 2015
Third Quarter 2015
Fourth Quarter 2015
First Quarter 2016
Monthly High and Low
October 2015
November 2015
December 2015
January 2016
February 2016
March 2016
April 2016 (through April 22, 2016)
B. Plan of Distribution
Not applicable.
C. Markets
$
Trading Price
High
Low
4.92 $
3.50
6.57
8.14
7.16
8.14
7.47
6.03
5.64
5.36
5.89
6.00
6.18
7.16
5.40
5.51
6.18
5.99
7.16
6.47
6.45
1.91
1.64
3.00
4.51
4.38
5.98
5.50
4.51
4.62
4.56
4.85
4.90
4.95
4.38
4.95
5.11
5.18
4.38
6.30
6.35
6.23
Our common shares have been listed on the NASDAQ Global Select Market since January 3, 2011 under the symbol “SVA.”
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D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
We are an Antiguan company with limited liability and our affairs are governed by our Articles of Incorporation, By-laws and the International Business
Corporation Act. The following are summaries of material provisions of our Articles of Incorporation, By-laws and the International Business Corporations Act.
General
All of our outstanding common shares are fully paid and non-assessable. The common shares are issued in registered form. Holders of common shares are
entitled to receive share certificates. Our shareholders who are non-residents of Antigua may freely hold and vote their common shares.
Dividends
The holders of our common shares are entitled to such dividends as may be declared by our board of directors subject to the International Business Corporations
Act.
Voting Rights
Each common share is entitled to one vote on all matters upon which the common shares are entitled to vote.
A quorum required for a meeting of shareholders consists of shareholders who hold at least a majority of our shares at the meeting present in person or by
proxy. Shareholders’ meetings are held annually and may be convened by our board of directors on its own initiative or upon a request to the directors by
shareholders holding in aggregate at least five percent of our issued share capital. Advance notice of at least 21 days is required for the convening of our annual
general meeting and other shareholders meetings.
Unless the International Business Corporations Act otherwise requires, resolutions to be passed by the shareholders requires a simple majority vote. Important
matters such as changes to our By-laws require a resolution passed by a vote of shareholders holding a majority of all the outstanding and issued shares.
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Transfer of Common Shares
Our shareholders may transfer common shares by endorsing the relevant share certificates, completing a share transfer form or by other proper evidence of
succession, assignment or authority to transfer.
Liquidation
On a return of capital on winding up or otherwise (other than on conversion, redemption or purchase of common shares), assets available for distribution among
the holders of common shares shall be distributed among the holders of the common shares on a pro rata basis. If our assets available for distribution are
insufficient to repay all of the paid-up capital, the assets will be distributed so that the losses are borne by our shareholders proportionately.
Inspection of Books and Records
Holders of our common shares will have no general right under Antigua law to inspect or obtain copies of our list of shareholders or our corporate records. They
may, however, access such corporate information as is publicly available in the Companies Registry in St. John’s, Antigua. We will also provide our
shareholders with annual audited consolidated financial statements.
Changes in Capital
We may from time to time by a resolution passed by a majority of the shares entitled to vote:
increase the share capital by such sum, to be divided into shares of such classes and amount, as the resolution may prescribe;
consolidate and divide all or any of our share capital into shares of a larger amount than our existing shares;
sub-divide our existing shares, or any of them into shares of a smaller amount provided that in the subdivision the proportion between the amount paid
and the amount, if any unpaid on each reduced share shall be the same as it was in case of the share from which the reduced share is derived; and
cancel any shares which, at the date of the passing of the resolution, have not been taken or agreed to be taken by any person and diminish the amount
of our share capital by the amount of the shares so cancelled.
We may by special resolution reduce our share capital and any capital redemption reserve in any manner authorized by law.
Differences in Corporate Law
The International Business Corporations Act is modeled after English law but does not follow many recent English law statutory enactments. In addition, the
International Business Corporations Act differs from laws applicable to United States corporations and their shareholders. Set forth below is a summary of the
significant differences between the provisions of the International Business Corporations Law applicable to us and the laws applicable to companies
incorporated in the United States and their shareholders.
Mergers and Similar Arrangements
Antigua and Barbuda law does not provide for mergers as that expression is understood under United States corporate law. However, there are statutory
provisions for amalgamation that facilitate the consolidation of companies, provided that the arrangement is approved by a majority number of each class of
shareholders and creditors with whom the arrangement is to be made, and who must in addition represent two-thirds in value of each such class of shareholders
or creditors, as the case may be, that are present and voting either in person or by proxy at a meeting, or meetings, convened for that purpose. The convening of
the meetings and subsequently the arrangement may be, but is not required to be, sanctioned by the High Court of Antigua and Barbuda. While a dissenting
shareholder has the right to express to the court his view that the transaction ought not to be approved, the court can be expected to approve the arrangement if it
determines that:
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the statutory provisions as to the dual majority vote have been met;
the shareholders have been fairly represented at the meeting in question;
the arrangement is such that a businessman would reasonably approve; and
the arrangement is not one that would more properly be sanctioned under some other provision of the International Business Corporations Act.
When a take-over offer is made and accepted (within four months) by holders of 90% of the shares affected, the offerer may, within a two-month period, require
the holders of the remaining shares to transfer such shares on the terms of the offer. An objection can be made to the High Court of Antigua and Barbuda but
this is unlikely to succeed unless there is evidence of fraud, bad faith or collusion.
If the arrangement and reconstruction is thus approved, the dissenting shareholder would have no rights comparable to appraisal rights, which would otherwise
ordinarily be available to dissenting shareholders of United States corporations, providing rights to receive payment in cash for the judicially determined value
of the shares.
Shareholders’ Suits
We are not aware of any reported class action or derivative action having been brought in a court in Antigua and Barbuda. In principle, the company itself will
normally be the proper claimant in actions against directors, and derivative actions may not generally be brought by a minority shareholder. However, based on
English authorities, which would in all likelihood be of persuasive authority in Antigua and Barbuda, there are exceptions to the foregoing principle, including
when:
a company acts or proposes to act illegally or ultra vires;
the act complained of, although not ultra vires, required a special resolution, which was not obtained; and
those who control the company are perpetrating a “fraud on the minority.”
Directors’ Fiduciary Duties
Under Delaware corporate law, a director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components:
the duty of care and the duty of loyalty. The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise
under similar circumstances. Under this duty, a director must inform himself of, and disclose to shareholders, all material information reasonably available
regarding a significant transaction. The duty of loyalty requires that a director act in a manner he reasonably believes to be in the best interests of the
corporation. He must not use his corporate position for personal gain or advantage. This duty prohibits self-dealing by a director and mandates that the best
interest of the corporation and its shareholders take precedence over any interest possessed by a director, officer or controlling shareholder and not shared by the
shareholders generally. In general, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the
action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties.
Should such evidence be presented concerning a transaction by a director, a director must prove the procedural fairness of the transaction, and that the
transaction was of fair value to the corporation. As a matter of Antigua and Barbuda law, a director of an Antigua and Barbuda company is in the position of a
fiduciary with respect to the company and therefore it is considered that he owes the following duties to the company — a duty to act bona fide in the best
interests of the company, a duty not to make a profit out of his position as director (unless the company permits him to do so) and a duty not to put himself in a
position where the interests of the company conflict with his personal interest or his duty to a third-party. A director of an Antigua and Barbuda company owes
to the company a duty to act with skill and care. It was previously considered that a director need not exhibit in the performance of his duties a greater degree of
skill than may reasonably be expected from a person of his knowledge and experience. However, English and Commonwealth courts have moved towards an
objective standard with regard to the required skill and care and these authorities are likely to be followed in Antigua and Barbuda.
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Shareholder Action by Written Consent
Under the Delaware General Corporation Law, a corporation may eliminate the right of shareholders to act by written consent by amendment to its certificate of
incorporation. Antigua and Barbuda law and our By-laws provide that shareholders may approve corporate matters by way of a unanimous written resolution
signed by or on behalf of each shareholder who would have been entitled to vote on such matter at a general meeting without a meeting being held.
Shareholder Proposals
Under the Delaware General Corporation Law, a shareholder has the right to put any proposal before the annual meeting of shareholders, provided it complies
with the notice provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the
governing documents, but shareholders may be precluded from calling special meetings. Antigua and Barbuda law and our By-laws allow our shareholders
holding not less than five per cent of the paid up voting share capital of the company to requisition a shareholder’s meeting. We are obligated under our By-laws
and the International Business Corporations Act to call shareholders’ annual general meetings.
Cumulative Voting
Under the Delaware General Corporation Law, cumulative voting for elections of directors is not permitted unless the corporation’s certificate of incorporation
specifically provides for it. Cumulative voting potentially facilitates the representation of minority shareholders on a board of directors since it permits the
minority shareholder to cast all the votes to which the shareholder is entitled on a single director, which increases the shareholder’s voting power with respect to
electing such director. As permitted under Antigua and Barbuda law, our By-laws will not provide for cumulative voting. As a result, our shareholders are not
afforded any less protections or rights on this issue than shareholders of a Delaware corporation.
Removal of Directors
Under the Delaware General Corporation Law, a director of a corporation with a classified board may be removed only for cause with the approval of a majority
of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise. Under our By-laws, directors can be removed by a majority
vote of the shareholders.
Transactions with Interested Shareholders
The Delaware General Corporation Law contains a business combination statute applicable to Delaware public corporations whereby, unless the corporation has
specifically elected not to be governed by such statute by amendment to its certificate of incorporation, it is prohibited from engaging in certain business
combinations with an “interested shareholder” for three years following the date that such person becomes an interested shareholder. An interested shareholder
generally is a person or a group who or which owns or owned 15% or more of the target’s outstanding voting stock within the past three years. This has the
effect of limiting the ability of a potential acquirer to make a two-tiered bid for the target in which all shareholders would not be treated equally. The statute
does not apply if, among other things, prior to the date on which such shareholder becomes an interested shareholder, the board of directors approves either the
business combination or the transaction which resulted in the person becoming an interested shareholder. This encourages any potential acquirer of a Delaware
public corporation to negotiate the terms of any acquisition transaction with the target’s board of directors.
Antigua and Barbuda law has no comparable statute. As a result, we cannot avail ourselves of the types of protections afforded by the Delaware business
combination statute. However, although Antigua and Barbuda law does not regulate transactions between a company and its significant shareholders, it does
provide that such transactions must be entered into bona fide in the best interests of the company and not with the effect of constituting a fraud on the minority
shareholders.
Dissolution; Winding Up
Under the Delaware General Corporation Law, unless the board of directors approves the proposal to dissolve, dissolution must be approved by shareholders
holding 100% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority
of the corporation’s outstanding shares. Delaware law allows a Delaware corporation to include in its certificate of incorporation a supermajority voting
requirement in connection with dissolutions initiated by the board. Under the International Business Corporations Law, our company may be dissolved,
liquidated or wound up only by the vote of holders of two-thirds of our shares voting at a meeting or the unanimous written resolution of all shareholders.
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Variation of Rights of Shares
Under the Delaware General Corporation Law, a corporation may vary the rights of a class of shares with the approval of a majority of the outstanding shares of
such class, unless the certificate of incorporation provides otherwise. Under Antigua and Barbuda law and our By-laws, if our share capital is divided into more
than one class of shares, we may vary the rights attached to any class only with the vote at a class meeting of holders of two-thirds of the shares of such class or
unanimous written resolution.
Amendment of Governing Documents
Under the Delaware General Corporation Law, a corporation’s governing documents may be amended with the approval of a majority of the outstanding shares
entitled to vote, unless the certificate of incorporation provides otherwise. As permitted by Antigua and Barbuda law, our By-laws may only be amended with
the vote of holders representing a majority of all our shares voting issued and outstanding or the unanimous written resolution of all shareholders. By-laws can
be amended by a vote or unanimous written resolution of the directors.
Indemnification of Directors and Executive Officers and Limitation of Liability
Antigua and Barbuda law does not limit the extent to which a company’s by-laws may provide for indemnification of officers and directors, except to the extent
any such provision may be held by the Antigua and Barbuda courts to be contrary to public policy, such as to provide indemnification against civil fraud or the
consequences of committing a crime. Our By-laws permit indemnification of officers and directors for losses, damages, costs and expenses incurred in their
capacities as such unless such losses or damages arise from negligence or illegal action of such directors or officers. This standard of conduct is generally the
same as permitted under the Delaware General Corporation Law to a Delaware corporation. In addition, we have entered into indemnification agreements with
our directors and senior executive officers that provide such persons with additional indemnification beyond that provided in our By-laws.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers or persons controlling us under the foregoing
provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is
therefore unenforceable as a matter of United States law.
We have obtained directors and officers insurance providing indemnification for our directors for certain liabilities.
Anti-takeover Provisions in the By-laws
Some provisions of our By-laws may discourage, delay or prevent a change in control of our company or management that shareholders may consider favorable,
including provisions that authorize our board of directors to issue preferred shares in one or more series and to designate the price, rights, preferences, privileges
and restrictions of such preferred shares without any further vote or action by our shareholders.
However, under Antigua and Barbuda law, our directors may only exercise the rights and powers granted to them under our By-laws for what they believe in
good faith to be in the best interests of our company.
Rights of Non-resident or Foreign Shareholders
There are no limitations imposed by our By-laws on the rights of non-resident or foreign shareholders to hold or exercise voting rights on our shares. In
addition, there are no provisions in our By-laws governing the ownership threshold above which shareholder ownership must be disclosed.
C. Material Contracts
We have not entered into any material contracts other than in the ordinary course of business and other than those described in “Item 4. Information on the
Company” or elsewhere in this annual report on Form 20-F.
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D. Exchange Controls
Foreign Currency Exchange
Pursuant to the Foreign Currency Administration Rules promulgated in 1996 and amended in 1997 and various regulations issued by SAFE and other relevant
PRC government authorities, renminbi is freely convertible only to the extent of current account items, such as trade related receipts and payments, interest and
dividends. Capital account items, such as direct equity investments, loans and repatriation of investment, require the prior approval from SAFE or its local
counterpart for conversion of renminbi into a foreign currency, such as U.S. dollars, and remittance of the foreign currency outside the PRC.
Payments for transactions that take place within PRC must be made in renminbi. Unless otherwise approved, PRC companies must repatriate foreign currency
payments received from abroad. Foreign-invested enterprises may retain foreign exchange in accounts with designated foreign exchange banks subject to a cap
set by SAFE or its local counterpart. Unless otherwise approved, domestic enterprises must convert all of their foreign currency receipts into renminbi.
E. Taxation
Antigua and Barbuda Taxation
We and our securities holders, other than those resident in Antigua and Barbuda, are exempt from Antigua and Barbuda income, corporation or profits tax,
withholding tax, capital gains tax, capital transfer tax, estate duty or inheritance tax. We are not subject to stamp or other similar duty on the issuance, transfer or
redemption of our common shares. Under Section 276 of the International Business Corporations Act of Antigua and Barbuda, the tax exemption we and our
securities holders currently enjoy will continue in effect for a period of 50 years from our date of incorporation, which is March 1, 1999. No reciprocal income
tax treaty affecting us exists between Antigua and Barbuda and the United States.
United States Federal Income Taxation
The following discussion describes the material U.S. federal income tax consequences to U.S. Holders (as defined below) under current law of an investment in
our common shares. This discussion applies only to U.S. Holders that hold our common shares as capital assets (generally, property held for investment) and
have the U.S. dollar as their functional currency. This discussion is based on the tax laws of the United States as in effect on the date of this annual report and on
U.S. Treasury regulations in effect or, in some cases, proposed as of the date of this annual report, as well as judicial and administrative interpretations thereof
available on or before such date. All of the foregoing authorities are subject to change, which change could apply retroactively and could affect the tax
consequences described below. The following discussion does not address all U.S. federal income tax consequences relevant to a U.S. Holder’s particular
circumstances, including the impact of the Medicare contribution tax on net investment income.
The following discussion does not deal with the tax consequences to any particular investor or to persons in special tax situations such as:
banks and other financial institutions;
insurance companies;
regulated investment companies;
real estate investment trusts;
broker-dealers;
traders that elect to use a mark-to-market method of accounting;
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U.S. expatriates;
tax-exempt entities;
persons liable for alternative minimum tax;
persons holding a common share as part of a straddle, hedging, conversion or integrated transaction;
persons that actually or constructively own 10% or more of the total combined voting power of all classes of our voting stock;
partnerships or other pass-through entities, or persons holding our common shares through such entities; or
persons who acquired our common shares pursuant to the exercise of any employee share option or otherwise as compensation.
INVESTORS ARE URGED TO CONSULT THEIR TAX ADVISORS REGARDING THE APPLICATION OF THE U.S. FEDERAL INCOME TAX RULES
TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE ESTATE AND GIFT, STATE, LOCAL AND FOREIGN TAX CONSEQUENCES TO
THEM OF THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR COMMON SHARES.
The discussion below of the U.S. federal income tax consequences to “U.S. Holders” will apply to you if you are a beneficial owner of our common shares and
you are, for U.S. federal income tax purposes:
an individual who is a citizen or resident of the United States;
a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States,
any state thereof or the District of Columbia;
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
a trust that (1) is subject to the primary supervision of a court within the United States and the control of one or more U.S. persons for all substantial
decisions or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
If a partnership (or other entity taxable as a partnership for U.S. federal income tax purposes) is a beneficial owner of our common shares, the tax treatment of a
partner in the partnership generally will depend upon the status of the partner and the activities of the partnership.
Taxation of Dividends and Other Distributions on Our Common Shares
Subject to the PFIC rules discussed below, the gross amount of any distributions we make to you with respect to our common shares generally will be includible
in your gross income in the year received as dividend income to the extent the distribution is paid out of our current or accumulated earnings and profits (as
determined under U.S. federal income tax principles). To the extent the amount of the distribution exceeds our current and accumulated earnings and profits,
such excess amount will be treated first as a tax-free return of your tax basis in your common shares, and then, to the extent such excess amount exceeds your
tax basis, as capital gain. We currently do not, and we do not intend to, calculate our earnings and profits under U.S. federal income tax principles. Therefore, a
U.S. Holder should expect that a distribution will generally be reported as a dividend even if that distribution would otherwise be treated as a non-taxable return
of capital or as capital gain under the rules described above. Any dividends we pay will not be eligible for the dividends-received deduction allowed to
corporations in respect of dividends received from U.S. corporations.
With respect to certain non-corporate U.S. Holders, including individual U.S. Holders, dividends may constitute “qualified dividend income” eligible to be
taxed at the preferential rate applicable to capital gains, provided that (1) our common shares are readily tradable on an established securities market in the
United States, or we are eligible for the benefits of a qualifying income tax treaty with the United States that includes an exchange of information program, (2)
we are neither a PFIC nor treated as such with respect to you (as discussed below) for the taxable year in which the dividend is paid or the preceding taxable
year and (3) certain holding period requirements are met. Under Internal Revenue Service authority, common shares are considered for the purpose of clause (1)
above to be readily tradable on an established securities market in the United States if they are listed on the NASDAQ Global Select Market, as our common
shares are. If we are treated as a “resident enterprise” for PRC tax purposes under the EIT Law (see “Item 10. Additional Information — E. Taxation — PRC
Taxation”), we may be eligible for the benefits of the income tax treaty between the United States and the PRC. You should consult your tax advisors regarding
the availability of the lower capital gains rate applicable to qualified dividend income for dividends paid with respect to our common shares.
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Dividends generally will constitute foreign source income for foreign tax credit limitation purposes. If the dividends are taxed as qualified dividend income (as
discussed above), the amount of the dividend taken into account for purposes of calculating the U.S. foreign tax credit limitation generally will be limited to the
gross amount of the dividend, multiplied by the reduced tax rate applicable to qualified dividend income and divided by the highest tax rate that would be
applicable to dividends if not for the reduced tax rate applicable to qualified dividend income.. The limitation on foreign taxes eligible for credit is calculated
separately with respect to specific classes of income. For this purpose, dividends distributed by us with respect to our common shares generally will constitute
“passive category income” but could, in the case of certain U.S. Holders, constitute “general category income.”
If PRC withholding taxes apply to dividends paid to you with respect to the common shares (see “Item 10. Additional Information — E. Taxation — PRC
Taxation”), subject to certain conditions and limitations, such PRC withholding taxes may be treated as foreign taxes eligible for credit against your U.S. federal
income tax liability. The rules relating to the determination of the foreign tax credit are complex, and you should consult your tax advisors regarding the
availability of a foreign tax credit in your particular circumstances.
Taxation of Disposition of Our Common Shares
Subject to the PFIC rules discussed below, you will recognize taxable gain or loss on any sale, exchange or other taxable disposition of a common share equal to
the difference between the amount realized for the common share and your tax basis in the common share. Your tax basis in our common shares will generally
equal the cost of such shares. The gain or loss generally will be capital gain or loss. If you are a non-corporate U.S. Holder, including an individual U.S. Holder,
who has held the common share for more than one year, you will be eligible for reduced tax rates. The deductibility of capital losses is subject to limitations.
Any gain or loss you recognize on a disposition of our common shares generally will be treated as U.S. source income or loss for foreign tax credit limitation
purposes. However, if we are treated as a resident enterprise for PRC tax purposes and PRC tax may be imposed on any gain from the disposition of the
common shares in accordance with the income tax treaty between the United States and the PRC (see “Item 10. Additional Information — E. Taxation — PRC
Taxation”), a U.S. Holder that is eligible for the benefits of the income tax treaty between the United States and the PRC may elect to treat the gain as PRC
source income. You should consult your tax advisors regarding the proper treatment of gain or loss in your particular circumstances.
Passive Foreign Investment Company
Based on the market price of our common shares, the value of our assets, and the composition of our income and assets, we do not believe we were a PFIC for
U.S. federal income tax purposes for our taxable year ended December 31, 2015.
A non-U.S. corporation will be a PFIC for any taxable year if either:
at least 75% of its gross income for such year is passive income, or
at least 50% of the value of its assets (based on an average of the quarterly values of the assets) during such year is attributable to assets that produce
passive income or are held for the production of passive income.
For purposes of the PFIC rules, passive income includes, among other things, dividends, interest, royalties, rents, annuities, and net gains from certain
commodity and foreign currency transactions, subject to certain exceptions. Passive income generally does not include rents and royalties derived from the
active conduct of a trade or business (other than from a related person). We will be treated as owning our proportionate share of the assets and earning our
proportionate share of the income of any other corporation in which we own, directly or indirectly, at least 25% (by value) of the stock.
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We must make a separate determination after the close of each year as to whether we were a PFIC for that year. The composition of our income and assets will
be affected by how, and how quickly, we use any cash we generate from our operations or raise in any offering. Because the value of our assets for purposes of
the PFIC test will generally be determined by reference to the market price of our common shares, fluctuations in the market price of our common shares may
cause us to become a PFIC for any subsequent year. If we are a PFIC for any year during which you hold our common shares, we generally will continue to be
treated as a PFIC with respect to you for all succeeding years during which you hold our common shares, unless we cease to be a PFIC and you make a “deemed
sale” election with respect to our common shares. If such election is made, you will be deemed to have sold common shares you hold at their fair market value
and any gain from such deemed sale would be subject to the rules described in the following two paragraphs. After the deemed sale election, your common
shares with respect to which such election was made will not be treated as shares in a PFIC unless we subsequently become a PFIC.
For each taxable year we are treated as a PFIC with respect to you, you will be subject to special tax rules with respect to any “excess distribution” you receive
and any gain you recognize from a sale or other disposition (including a pledge) of the common shares, unless you make a “mark-to-market” election as
discussed below. Distributions you receive in a taxable year that are greater than 125% of the average annual distributions you received during the shorter of the
three preceding taxable years or your holding period for the common shares before the current year will be treated as an excess distribution. Under these special
tax rules:
the excess distribution or recognized gain will be allocated ratably over your holding period for the common shares;
the amount allocated to the current taxable year, and any taxable years in your holding period prior to the first taxable year in which we became a
PFIC, will be treated as ordinary income; and
the amount allocated to each other year will be subject to the highest income tax rate in effect for individuals or corporations, as applicable, for each
such year, and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year.
The tax liability for amounts allocated to years prior to the year of disposition or excess distribution cannot be offset by any net operating losses for such years,
and gains (but not losses) from a sale or other disposition of the common shares are not taxed at reduced tax rates, even if you hold the common shares as capital
assets.
If we are treated as a PFIC with respect to you for any taxable year, to the extent any of our subsidiaries are also PFICs or we make direct or indirect equity
investments in other entities that are PFICs, you will be deemed to own shares in such lower-tier PFICs directly or indirectly owned by us in the proportion that
the value of the common shares you own bears to the value of all of our common shares, and you may be subject to the rules described in the preceding two
paragraphs with respect to the shares of such lower-tier PFICs that you would be deemed to own. You should consult your tax advisors regarding the application
of the PFIC rules to any of our subsidiaries.
A U.S. Holder of marketable stock (as defined below) in a PFIC may make a mark-to-market election for such stock to elect out of the PFIC rules described
above regarding excess distributions and recognized gains. If you make a mark-to-market election for the common shares, you will include in income for each
year that we are a PFIC an amount equal to the excess, if any, of the fair market value of the common shares as of the close of your taxable year over your
adjusted basis in such common shares. You will be allowed a deduction for the excess, if any, of the adjusted basis of the common shares over their fair market
value as of the close of the taxable year. However, deductions will be allowable only to the extent of any net mark-to-market gains on the common shares
included in your income for prior taxable years. Amounts included in your income under a mark-to-market election, as well as gain from the actual sale or other
disposition of the common shares will be treated as ordinary income. Ordinary loss treatment will apply to the deductible portion of any mark-to-market loss on
the common shares, as well as to any loss from the actual sale or other disposition of the common shares, to the extent that the amount of such loss does not
exceed the net mark-to-market gains previously included for such common shares. Your basis in the common shares will be adjusted to reflect any such income
or loss amounts. If you make a valid mark-to-market election, any distributions we make would generally be subject to the tax rules discussed above under “—
Taxation of Dividends and Other Distributions on Our Common Shares,” and the lower capital gains rate applicable to qualified dividend income would not
apply.
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The mark-to-market election is available only for “marketable stock,” which generally is defined as stock that is traded in greater than de minimis quantities on
at least 15 days during each calendar quarter (“regularly traded”) on a qualified exchange or other market, as defined in applicable U.S. Treasury regulations.
Our common shares are listed on the NASDAQ Global Select Market, which is a qualified exchange or other market for these purposes. Consequently, if the
common shares remain listed on the NASDAQ Global Select Market and are regularly traded, and you are a holder of common shares, we expect the mark-to-
market election would be available to you if we become a PFIC. Because a mark-to-market election cannot be made for equity interests in any lower-tier PFICs
that we own, a U.S. Holder may continue to be subject to the PFIC rules described above regarding excess distributions and recognized gains with respect to its
indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes.
Alternatively, a U.S. Holder of stock in a PFIC may make a “qualified electing fund” election with respect to such corporation to elect out of the PFIC rules
described above regarding excess distributions and recognized gains. A U.S. Holder that makes a qualified electing fund election with respect to a PFIC will
generally include in income such holder’s pro rata share of the corporation’s income on a current basis. However, you may make a qualified electing fund
election with respect to your common shares only if we furnish you annually with certain tax information, and we currently do not intend to prepare or provide
such information.
Each U.S. shareholder of a PFIC is required to file an annual report containing such information as the U.S. Treasury requires. If we become a PFIC, you should
consult your tax advisors regarding any reporting requirements that may apply to you.
You are urged to consult your tax advisors regarding the application of the PFIC rules to your investment in our common shares.
Information Reporting and Backup Withholding
Dividend payments with respect to our common shares and proceeds from the sale, exchange or redemption of our common shares may be subject to
information reporting to the Internal Revenue Service and possible U.S. backup withholding at a current rate of 28%. Backup withholding will not apply,
however, to a U.S. Holder that furnishes a correct taxpayer identification number and makes any other required certification on Internal Revenue Service Form
W-9 or that is otherwise exempt from backup withholding. U.S. Holders that are required to establish their exempt status generally must provide such
certification on Internal Revenue Service Form W-9. U.S. Holders should consult their tax advisors regarding the application of the U.S. information reporting
and backup withholding rules.
Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against your U.S. federal income tax liability, and you
may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the Internal Revenue
Service and furnishing any required information in a timely manner.
Additional Reporting Requirements
Certain U.S. Holders who are individuals are required to report information relating to an interest in our common shares, subject to certain exceptions (including
an exception for common shares held in accounts maintained by certain financial institutions). U.S. Holders should consult their tax advisors regarding the
effect, if any, of these rules on their ownership and disposition of our common shares.
PRC Taxation
Under the EIT Law, enterprises established under the laws of non-PRC jurisdictions but whose “de facto management body” is located in China are considered
“resident enterprises” for PRC tax purposes. Under the implementation regulations issued by the State Council relating to the EIT Law, “de facto management
bodies” are defined as the bodies that have material and overall management control over the business, personnel, accounts and properties of an enterprise. In
2009, the State Administration of Taxation issued a circular, known as Circular 82, which provides certain specific criteria for determining whether the “de facto
management body” of a PRC-controlled offshore incorporated enterprise is located in China. Although this circular only applies to offshore enterprises
controlled by PRC enterprises or PRC enterprise groups, not those controlled by PRC individuals or foreigners, the criteria set forth in the circular may reflect
the State Administration of Taxation’s general position on how the “de facto management body” text should be applied in determining the tax resident status of
all offshore enterprises. According to Circular 82, an offshore incorporated enterprise controlled by a PRC enterprise or a PRC enterprise group will be regarded
as a PRC tax resident by virtue of having its “de facto management body” in China only if all of the following conditions are met: (i) the primary location of the
day-to-day operational management is in the PRC; (ii) decisions relating to the enterprise’s financial and human resource matters are made or are subject to
approval by organizations or personnel in the PRC; (iii) the enterprise’s primary assets, accounting books and records, company seals, and board and
shareholders minutes, are located or maintained in the PRC; and (iv) at least 50% of voting board members or senior executives habitually reside in the PRC.
Substantially all of our management are currently based in China, and may remain in China in the future. If we were treated as a “resident enterprise” for PRC
tax purposes, we would be subject to PRC income tax on our worldwide income at a uniform tax rate of 25%. Dividends received by us from our PRC
subsidiaries may be exempt from PRC withholding tax.
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Under the EIT Law and its implementation regulations, dividends paid to a non-PRC investor are generally subject to a 10% PRC withholding tax, if such
dividends are derived from sources within China and the non-PRC investor is considered to be a non-resident enterprise without any establishment or place of
business within China or if the dividends paid have no connection with the non-PRC investor’s establishment or place of business within China, unless such tax
is eliminated or reduced under an applicable tax treaty. Similarly, any gain realized on the transfer of common shares by such investor is also subject to a 10%
PRC withholding tax if such gain is regarded as income derived from sources within China, unless such tax is eliminated or reduced under an applicable tax
treaty.
If we were considered a PRC “resident enterprise”, it is possible that the dividends we pay with respect to our common shares, or the gain you may realize from
the transfer of our common shares, would be treated as income derived from sources within China and be subject to income tax at 10%.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the periodic reporting and other informational requirements of the Exchange Act. Under the Exchange Act, we are required to file reports and
other information with the SEC. Specifically, we are required to file annually a Form 20-F within four months after the end of each fiscal year. Copies of reports
and other information, when so filed, may be inspected without charge and may be obtained at prescribed rates at the public reference facilities maintained by
the SEC at Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549, and at the regional office of the SEC located at Citicorp Center, 500 West Madison
Street, Suite 1400, Chicago, Illinois 60661. The public may obtain information regarding the Washington, D.C. Public Reference Room by calling the SEC at 1-
800-SEC-0330. The SEC also maintains a web site at www.sec.gov that contains reports, proxy and information statements, and other information regarding
registrants that make electronic filings with the SEC using its EDGAR system. As a foreign private issuer, we are exempt from the rules under the Exchange
Act prescribing the furnishing and content of quarterly reports and proxy statements, and officers, directors and principal shareholders are exempt from the
reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.
We will furnish the transfer agent of our common shares, with our annual reports, which will include a review of operations and annual audited consolidated
financial statements prepared in conformity with U.S. GAAP, and all notices of shareholders’ meetings and other reports and communications that are made
generally available to our shareholders. The transfer agent will make such notices, reports and communications available to holders of our common shares and,
upon our request, will mail to all record holders of our common shares the information contained in any notice of a shareholders’ meeting received by the
transfer agent from us.
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In accordance with the NASDAQ Rules, we will post this annual report on Form 20-F on our website www.sinovac.com. In addition, we will provide hardcopies
of our annual report free of charge to shareholders upon request.
I.
Subsidiary Information
For a listing of our subsidiaries, see “Item 4. Information on the Company — C. Organizational Structure.”
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Foreign Exchange Risk
Substantially all of our revenues and most of our costs and our expenses are denominated in renminbi. Our exposure to foreign exchange risk primarily relates
to cash and cash equivalents denominated in U.S. dollars as a result of our past issuances of common shares through a private placement and proceeds from our
public offering of common shares. Furthermore, the renminbi prices of some of the materials and supplies for reagent kits that are imported from companies in
the United States, Sweden and United Kingdom may be affected by fluctuations in the value of renminbi against the currencies of those countries. We also incur
professional, investor relations, director compensation and miscellaneous fees related to our operations as a public company that are denominated in U.S.
dollars.
The value of the renminbi against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in China’s political and
economic conditions. The conversion of renminbi into foreign currencies, including U.S. dollars, has been based on rates set by the People’s Bank of China. The
PRC government allows the renminbi to fluctuate within a narrow and managed band against a basket of certain foreign currencies. In recent years, the
exchange rate between the renminbi and U.S. dollar has been relatively stable and consequently the renminbi has fluctuated sharply against other freely traded
currencies in tandem with the U.S. dollar. The PRC government has indicated that it will make effort to widen the trading band of the renminbi exchange rate,
which increases the possibility of sharp fluctuations in renminbi’s value in the future as well as the unpredictability associated with renminbi’s exchange rate.
By way of example, assuming we had converted a U.S. dollar denominated cash balance of $1.0 million as of December 31, 2015 into renminbi at the exchange
rate of $1.00 for RMB6.4778 as of December 31, 2015, such a cash balance would have been RMB6.48 million. Assuming a 1% appreciation/depreciation of
the renminbi against the U.S. dollar, such a cash balance would have decreased/increased by RMB64,800 as of December 31, 2015.
Our financial statements are expressed in U.S. dollars but our subsidiaries’ functional currency is renminbi. The value of our shares will be affected by the
foreign exchange rate between U.S. dollars and renminbi. To the extent we hold assets denominated in U.S. dollars, any appreciation of the renminbi against the
U.S. dollar could result in a change to our statements of comprehensive income and a reduction in the value of our U.S. dollar denominated assets. On the other
hand, a decline in the value of renminbi against the U.S. dollar could reduce the U.S. dollar equivalent amounts of our financial results, the value of your
investment in our company and the dividends we may pay in the future, if any, all of which may have a material adverse effect on the prices of our shares.
Interest Rate Risk
Our exposure to interest rate risk relates primarily to the interest expense associated with our short-term and/or long-term bank borrowings as well as interest
income provided by excess cash invested in demand and term deposits. Such borrowing and interest-earning instruments carry a degree of interest rate risk. We
have not historically used, and do not expect to use in the future, any derivative financial instruments to manage our exposure to interest risk. We have not been
exposed nor do we anticipate being exposed to material risks due to changes in interest rates. The weighted effective interest rate on our outstanding loans was
6.0%, 6.8% and 6.6% for the years ended December 31, 2015, 2014 and 2013. A hypothetical increase or decrease in interest rates of 1% would increase or
decrease our annual interest and financing expenses by $0.2 million based on our outstanding indebtedness as of December 31, 2015.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not applicable.
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PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
None.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
A. — D. Material Modifications to the Rights of Security Holders
In March 2016, we adopted the Rights Plan. Pursuant to the Rights Plan, subject to limited exceptions, upon (i) a person or group obtaining ownership of 15%
or more of our common shares or (ii) the commencement or announcement of an intention to make a tender offer or exchange offer, the consummation of which
would result in the beneficial ownership by a person or group of 15% or more of our common shares, in each case, without the approval of our board of
directors, each Right will entitle the holders, other than the Acquiring Person, to buy, at an exercise price of $30.00, one one-thousandth of a Series A Preferred
Share. Holders are entitled to receive, in lieu of each one one-thousandths of a Series A Preferred Share, common shares having a market value at that time of
twice the Right’s exercise price. Our board of directors is entitled to redeem the Rights at $0.001 per Right at any time before the Rights are exercisable.
E. Use of Proceeds
On February 2, 2010, we completed a follow-on public offering of our common shares. In this follow-on offering, we issued and sold an aggregate of
11,500,000 common shares at $5.75 per share. The common shares offered and sold were registered pursuant to the registration statement on Form F-3 (File
Number: 333-163165) effective on November 30, 2010 and the registration statement on Form F-3 (File Number: 333-164559) effective on January 27, 2010.
UBS Securities LLC and Piper Jaffray & Co. were the representatives of the underwriters of the offering. We received net proceeds of approximately $61.8
million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We have spent approximately $16.4 million in
the acquisition of Sinovac Dalian and $25.4 million in pipeline development and corporate activities of entities in PRC.
We intend to use the remaining net proceeds we received from this offering for the following purposes:
up to $10.0 million to fund the research and development of our product candidates; and
the remaining amount for general corporate purposes.
The foregoing use of our net proceeds received from this offering represents our current intentions based upon our present plans and business condition. The
amounts and timing of any expenditure will vary depending on the amount of cash generated by our operations, competitive and technological developments
and the rate of growth, if any, of our business. Accordingly, our management will have significant discretion in the allocation of the net proceeds we received
from this offering. Depending on future events and other changes in the business climate, we may determine at a later time to use the net proceeds for different
purposes, including repayment of certain of our outstanding bank borrowings. Pending the use of the net proceeds, we intend to invest the net proceeds in a
variety of capital preservation instruments, including short-term, investment-grade, interest-bearing instruments.
ITEM 15. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
In connection with the preparation of this annual report on Form 20-F, we carried out an evaluation of the effectiveness of our disclosure controls and
procedures, which is defined in Rules 13a-15(e) of the Exchange Act, as of the period covered by this annual report.
88
Based on this evaluation, our chief executive officer and chief financial officer concluded that, as of December 31, 2015, our disclosure controls and procedures
were effective in ensuring that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act was recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that the information required to be disclosed by us in
the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our chief executive officer and chief
financial officer, to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, which is defined in Rules 13a-15(f) and 15d-
15(f) of the Exchange Act. Our internal control system was designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation and fair presentation of the consolidated financial statements for external purposes in accordance with accounting principles generally accepted in
the United States and includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect
the transactions and dispositions of a company’s assets, (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
consolidated financial statements in accordance with generally accepted accounting principles, and that a company’s receipts and expenditures are being made
only in accordance with authorizations of a company’s management and directors, and (iii) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of a company’s assets that could have a material effect on the consolidated financial statements.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2015. In making this
assessment, we used the criteria established within the Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (2013 framework). This evaluation included review of the documentation of controls, evaluation of the design effectiveness of controls,
testing of the operating effectiveness of controls and a conclusion on this evaluation. All internal control systems, no matter how well designed, have inherent
limitations. Therefore, even those systems determined to be effective may not prevent or detect misstatements and can provide only reasonable assurance with
respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Based on this assessment, our management has concluded that our internal control over financial reporting was effective as of December 31, 2015.
Ernst & Young Hua Ming LLP, an independent registered public accounting firm that audited the financial statements included in this annual report, has issued
an attestation report on the effectiveness of our internal control over financial reporting.
Attestation Report of the Registered Public Accounting Firm
The attestation report issued by Ernst & Young Hua Ming LLP, an independent registered public accounting firm, on the effectiveness of internal control over
financial reporting can be found on page F-4 of this annual report.
Changes in Internal Control over Financial Reporting
As required by Rule 13a-15(d), under the Exchange Act, our management, including our chief executive officer and chief financial officer, has conducted an
evaluation of our internal control over financial reporting to determine whether any changes occurred during the period covered since last report have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting. Based on this evaluation, it has been determined that there has
been no change during the period covered by this annual report.
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
Our board of directors has determined that we have at least one audit committee financial expert serving on our audit committee. Our audit committee financial
expert is Mr. Simon Anderson. Each member of our audit committee, including Mr. Anderson, satisfies the “independence” requirements of the NASDAQ
Marketplace rule and Rule 10A-3 under the Exchange Act.
89
ITEM 16B. CODE OF ETHICS
Our board of directors has adopted a code of ethics that applies to our directors, officers, employees and agents, including certain provisions that specifically
apply to our chief executive officer, chief financial officer, vice presidents and any other persons who perform similar functions for us. We have filed our code
of business conduct and ethics as an exhibit our annual report on Form 20-F (file no. 001-32371) filed with the SEC on July 14, 2006, and posted the code on
our website at www.sinovac.com. We hereby undertake to provide to any person without charge, a copy of our code of business conduct and ethics within ten
working days after we receive such person’s written request.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth the aggregate fees by categories specified below in connection with certain professional services rendered by Ernst & Young LLP
and Ernst & Young Hua Ming LLP, for the periods indicated below.
Audit fees(1)
- Ernst & Young LLP
- Ernst & Young Hua Ming LLP
Audited-related fees(2)
Tax fees(3)
All other fees(4)
2015
2014
$
— $
0.9 million $
—
—
—
19,000
0.6 million
—
—
—
(1) “Audit fees” means the aggregate fees billed in each of the fiscal years listed for professional services rendered by our principal auditors for the audit of our
annual financial statements included in our annual reports on Form 20-F or services that are normally provided by accountants in connection with statutory
and regulatory engagements for those fiscal years.
(2) “Audit-related fees” means the aggregate fees billed in each of the fiscal years listed for assurance and related services rendered by our principal auditors
that are reasonably related to the performance of the audit of our financial statements and are not reported under “Audit fees.”
(3) “Tax fees” means the aggregate fees billed in each of the fiscal years listed for professional services rendered by our principal auditors for tax compliance,
tax advice, and tax planning.
(4) “All other fees” means the aggregate fees billed in each of the fiscal years listed for products and services provided by our principal accountant, other than
the services reported in the other categories.
Before our independent auditors are engaged to render any services, the terms and fees of the engagement are reviewed by the audit committee before our audit
committee grants approval. All services as described above have been approved by our audit committee.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
None.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
None.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
None.
ITEM 16G. CORPORATE GOVERNANCE
Our corporate governance practices do not differ in any significant way from those followed by domestic companies under the listing standards of the NASDAQ
Global Select Market.
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ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
PART III
ITEM 17.
FINANCIAL STATEMENTS
We have elected to provide financial statements pursuant to Item 18.
ITEM 18.
FINANCIAL STATEMENTS
The consolidated financial statements of our company are included at the end of this annual report.
ITEM 19. EXHIBITS
Exhibit Number
1.1
Description of Document
Articles of Incorporation and By-laws, as amended on March 21, 2006 and July 14, 2011 (incorporated by reference to Exhibit 1.1 from
our annual report on Form 20-F (file no. 001-32371) filed with the Securities and Exchange Commission on April 12, 2012)
4.1
4.2
4.3
4.4
4.5
4.6
4.7
Translation of a Lease between Sinovac Beijing and SinoBioway related to a building of approximately 28,000 square feet, dated
August 12, 2004 (incorporated by reference to Exhibit 4.1 from our annual report on Form 20-F (file no. 001-32371) filed with the
Securities and Exchange Commission on July 14, 2006)
Translation of a Lease between Sinovac Beijing and SinoBioway related to a building of approximately 13,300 square feet, dated
August 12, 2004 (incorporated by reference to Exhibit 4.2 from our annual report on Form 20-F (file no. 001-32371) filed with the
Securities and Exchange Commission on July 14, 2006)
Translation of a Supplement Agreement to the Leases between Sinovac Beijing and SinoBioway (incorporated by reference to Exhibit
4.3 from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and Exchange Commission on July 14, 2006)
Stock Option Plan adopted on November 1, 2003 (incorporated by reference to Exhibit 4.4 from our annual report on Form 20-F (file
no. 001-32371) filed with the Securities and Exchange Commission on July 14, 2006)
Form of Employment Agreement between the Registrant and Weidong Yin, dated July 7, 2006 (incorporated by reference to Exhibit 4.5
from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and Exchange Commission on July 14, 2006)
Translation of Form of Employment Agreement between the Registrant or its subsidiary and any other senior executive officers of the
Registrant or its subsidiary (incorporated by reference to Exhibit 4.6 from our annual report on Form 20-F (file no. 001-32371) filed
with the Securities and Exchange Commission on July 14, 2006)
Form of Non-disclosure, Non-competition and Proprietary Information Agreement between the Registrant or its subsidiary and any
other senior executive officers of the Registrant or its subsidiary (incorporated by reference to Exhibit 4.7 from our annual report on
Form 20-F (file no. 001-32371) filed with the Securities and Exchange Commission on July 14, 2006)
91
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
Translation of a Lease between Sinovac Beijing and SinoBioway related to buildings of approximately 37,000 square feet, dated June 4,
2007 (incorporated by reference to Exhibit 4.8 from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and
Exchange Commission on March 31, 2008)
Share Purchase Agreement between Sinovac Biotech Ltd. and Sansar Capital Management LLC dated January 22, 2008 (incorporated
by reference to Exhibit 4.9 from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and Exchange
Commission on March 31, 2008)
Exclusive Promotion Service Agreement between Sinovac Beijing and GlaxoSmithKline (China) Investment Co., Ltd., dated July 30,
2007 (incorporated by reference to Exhibit 4.10 from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and
Exchange Commission on March 31, 2008)
Equity Joint Venture Contract dated November 22, 2009 between Sinovac Hong Kong and Dalian Jin Gang (English Translation)
(incorporated by reference to Exhibit 99.1 from our current report on Form 6-K (file no. 001-32371) filed with the Securities and
Exchange Commission on January 20, 2010)
Memorandum of Understanding dated November 22, 2009 between Sinovac Hong Kong and Dalian Jin Gang (English Translation)
(incorporated by reference to Exhibit 99.2 from our current report on Form 6-K (file no. 001-32371) filed with the Securities and
Exchange Commission on January 20, 2010)
Equity Interest Transfer Agreement dated December 17, 2009 between Sinovac Hong Kong and Dalian Jin Gang (English Translation)
(incorporated by reference to Exhibit 99.3 from our current report on Form 6-K (file no. 001-32371) filed with the Securities and
Exchange Commission on January 20, 2010)
Asset Acquisition Agreement dated February 10, 2010 between Sinovac Beijing and Beijing Xingchang High-tech Development Co.,
Ltd. (English Translation) (incorporated by reference to Exhibit 4.10 from our annual report on Form 20-F (file no. 001-32371) filed
with the Securities and Exchange Commission on April 16, 2010)
2012 Share Incentive Plan adopted on August 22, 2012 (incorporated by reference to Exhibit 4.15 from our annual report on Form 20-F
(file no. 001-32371) filed with the Securities and Exchange Commission on April 30, 2013)
Translation of a Supplemental Agreement, dated April 8, 2013, to a Lease Contract between Sinovac Beijing and SinoBioway, dated
August 12, 2004 (incorporated by reference to Exhibit 4.16 from our annual report on Form 20-F (file no. 001-32371) filed with the
Securities and Exchange Commission on April 30, 2013)
Translation of a Supplemental Agreement, dated April 8, 2013, to a Lease Contract between Sinovac Beijing and SinoBioway, dated
June 4, 2007 (incorporated by reference to Exhibit 4.17 from our annual report on Form 20-F (file no. 001-32371) filed with the
Securities and Exchange Commission on April 30, 2013)
Translation of a Supplemental Agreement, dated August 12, 2010, to a Lease Contract between Sinovac Beijing and SinoBioway, dated
August 12, 2004 (incorporated by reference to Exhibit 4.18 from our annual report on Form 20-F (file no. 001-32371) filed with the
Securities and Exchange Commission on April 30, 2013)
92
4.19
4.20
8.1*
11.1
12.1*
12.2*
13.1**
13.2**
15.1*
Translation of a Supplemental Agreement, dated April 8, 2013, to a Lease Contract between Sinovac Beijing and SinoBioway, dated
August 12, 2004, and the Supplemental Agreement between Sinovac Beijing, Sinovac R&D and SinoBioway, dated August 12, 2010
(incorporated by reference to Exhibit 4.19 from our annual report on Form 20-F (file no. 001-32371) filed with the Securities and
Exchange Commission on April 30, 2013)
Rights Agreement, dated March 28, 2016, between Sinovac Biotech Ltd. and Pacific Stock Transfer Company (incorporated by
reference to Exhibit 4.1 of our Report on Form 6-K dated March 29, 2016)
List of Subsidiaries
Code of Business Conduct and Ethics (incorporated by reference to Exhibit 11.1 from our annual report on Form 20-F (file no. 001-
32371) filed with the Securities and Exchange Commission on July 14, 2006)
CEO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
CFO Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
CEO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
CFO Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Consent of Ernst & Young Hua Ming LLP
101.INS*
XBRL Instance Document
101.SCH*
XBRL Taxonomy Extension Scheme Document
101.CAL*
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
XBRL Taxonomy Extension Presentation Linkbase Document
* Filed with this annual report on Form 20-F
** Furnished with this annual report on Form 20-F
93
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this
annual report on its behalf.
SIGNATURES
Date: April 25, 2016
Sinovac Biotech Ltd.
By:
/s/ Weidong Yin
Name: Weidong Yin
Title: Chairman and Chief Executive Officer
94
SINOVAC BIOTECH LTD.
CONSOLIDATED FINANCIAL STATEMENTS
(Expressed in thousands of U.S. dollars, unless otherwise stated)
December 31, 2015 and 2014
F-1
Index
Reports of Independent Registered Public Accounting Firm – Ernst & Young Hua Ming LLP
Consolidated Balance Sheets
Consolidated Statements of Comprehensive Income (Loss)
Consolidated Statements of Changes in Shareholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-2
F-3
F-5
F-6
F-7
F-10
F-11
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders of Sinovac Biotech Ltd.
We have audited the accompanying consolidated balance sheets of Sinovac Biotech Ltd. (the “Company”) as of December 31, 2015 and 2014, and the related
consolidated statements of comprehensive income (loss), shareholders' equity, and cash flows for each of the three years in the period ended December 31,
2015. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Sinovac
Biotech Ltd. at December 31, 2015 and 2014, and the consolidated results of its operations and its cash flows for each of the three years in the period ended
December 31, 2015, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Sinovac Biotech Ltd.’s internal
control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated April 25, 2016 expressed an unqualified opinion thereon.
/s/ Ernst & Young Hua Ming LLP
Beijing, The People’s Republic of China
April 25, 2016
F-3
Report of Independent Registered Public Accounting Firm
The Board of Directors and Shareholders of Sinovac Biotech Ltd.
We have audited Sinovac Biotech Ltd.’s internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). Sinovac
Biotech Ltd.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of
internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In our opinion, Sinovac Biotech Ltd. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on
the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of
Sinovac Biotech Ltd. as of December 31, 2015 and 2014, and the related consolidated statements of comprehensive income (loss), shareholders’ equity, and
cash flows for each of the three years in the period ended December 31, 2015 of Sinovac Biotech Ltd., and our report dated April 25, 2016 expressed an
unqualified opinion thereon.
/s/ Ernst & Young Hua Ming LLP
Beijing, The People’s Republic of China
April 25, 2016
F-4
SINOVAC BIOTECH LTD.
Consolidated Balance Sheets
As of December 31, 2015 and 2014
(Expressed in thousands of U.S. dollars, except for number of shares and per share data)
December 31,
2015
December 31,
2014
ASSETS
Current assets
Cash and cash equivalents
Restricted cash (note 4)
Accounts receivable – net (notes 5 and 11)
Inventories (note 6)
Prepaid expenses and deposits (including prepaid expenses
to related party of 2015 - $352, 2014 - $157) (note 12 (b))
Deferred tax assets (note 14)
Current assets held for sale (note 3)
Total current assets
Property, plant and equipment (notes 8 and 11)
Prepaid land lease payments (notes 9 and 11)
Long–term inventories (note 7)
Long–term prepaid expenses (including prepaid expenses to related party of 2015 - $25, 2014 - $3) (note 12
(b))
Prepayments for acquisition of equipment
Deferred tax assets (note 14)
Licenses (note 10)
Long-term assets held for sale (note 3)
Total assets
LIABILITIES AND EQUITY
Current liabilities
$
$
63,834
1,626
39,021
18,685
958
2,603
1,797
128,524
63,940
9,574
-
25
328
593
-
-
$
202,984
$
Short-term bank loans and current portion of long-term bank loans and other debt (note 11)
Loan from a non-controlling shareholder (note 12 (a))
Accounts payable and accrued liabilities (note 13)
Income tax payable
Deferred revenue (note 15)
Deferred government grants (note 16)
Current liabilities held for sale (note 3)
$
Total current liabilities
Deferred government grants (note 16)
Long-term bank loans and other debt (note 11)
Deferred revenue (note 15)
Other non-current liabilities (note 14)
Long-term liabilities held for sale (note 3)
Total long-term liabilities
Total liabilities
Commitments and contingencies (notes 17 and 24)
EQUITY
Preferred stock
Authorized 50,000,000 shares at par value of $0.001 each
Issued and outstanding: nil
Common stock (note 18)
Authorized: 100,000,000 shares at par value of $0.001 each
Issued and outstanding: 56,906,561 (2014 – 55,809,661)
Additional paid-in capital
Accumulated other comprehensive income
Statutory surplus reserves (note 20)
Accumulated deficit
Total shareholders' equity
Non-controlling interests (note 21)
$
21,775
2,470
22,524
1,643
8,144
1,202
243
58,001
4,730
756
-
756
-
6,242
64,243
-
57
109,944
8,110
13,450
(8,281)
123,280
15,461
91,293
-
40,719
18,712
1,426
2,266
387
154,803
66,233
10,261
2,648
3
1,387
515
352
2,328
238,530
47,375
2,595
22,538
1,101
4,996
530
699
79,834
7,494
1,803
7,191
454
28
16,970
96,804
-
56
108,243
12,022
12,627
(6,384)
126,564
15,162
Total equity
Total liabilities and equity
138,741
$
202,984
$
141,726
238,530
The accompanying notes are an integral part of these consolidated financial statements.
F-5
SINOVAC BIOTECH LTD.
Consolidated Statements of Comprehensive Income (Loss)
For the years ended December 31, 2015, 2014 and 2013
(Expressed in thousands of U.S. Dollars, except for number of shares and per share data)
Sales (note 23)
Cost of sales
Gross profit
$
Selling, general and administrative expenses (including rent expenses incurred to related party of
2015 - $852, 2014 - $869, 2013 - $847) (note 12(b))
Provision (recovery) for doubtful accounts
Research and development expenses – (net of
2015- $16, 2014 - $nil, 2013 $nil in government research grants)
Loss on disposal and impairment of property, plant and equipment (note 8)
Government grants recognized in income
Total operating expenses
Operating income
For the year ended December 31
2015
67,414 $
2014
62,932
$
18,425
48,989
15,476
47,456
37,436
34,166
(49)
329
2013
71,774
20,505
51,269
33,611
(504)
9,490
10,934
8,128
26
(1,637)
45,266
3,723
74
(104)
45,399
2,057
88
-
41,323
9,946
Interest and financing expenses – (Including interest expenses incurred to related party, 2015 -
$183, 2014 - $221, 2013 - $237) (note 12(b))
(1,920)
(3,407)
(3,031)
Interest income
Other income
Income from continuing operations before income taxes
Income tax benefit (expense) (note 14)
Income from continuing operations
Loss from discontinued operations, net of tax of nil (note 3)
Net income (loss)
Less: (income) attributable to non-controlling interests
1,155
73
2,684
1,312
3,031
2,646
(2,516)
(1,458)
515
(728)
(213)
(861)
1,188
(1,524)
(336)
(515)
2,167
329
9,411
2,225
11,636
(1,266)
10,370
(2,928)
Net income (loss) attributable to shareholders of Sinovac
$
(1,074) $
(851) $
7,442
Income (loss) from continuing operations
Other comprehensive income (loss) from continuing operations, net of tax of nil
Foreign currency translation adjustments
Comprehensive income (loss) from continuing operations
Loss from discontinued operations
Other comprehensive income (loss) from discontinued operations, net of tax of nil
Foreign currency translation adjustments
Comprehensive (loss) from discontinued operations
$
Comprehensive income (loss)
Less: comprehensive (income) attributable to non-controlling interests
Comprehensive income (loss) attributable to shareholders of Sinovac
Earnings (loss) per share (note 22)
Basic net income (loss) per share:
Continuing operations
Discontinued operations
Basic net income (loss) per share
Diluted net income (loss) per share:
Continuing operations
515
1,188
(4,137)
(3,622)
(2,344)
(1,156)
(728)
(1,524)
(338)
(1,066) $
(4,688)
(298)
(4,986)
(83)
(1,607) $
(2,763)
(207)
(2,970)
(0.01)
(0.01)
(0.02)
0.01
(0.03)
(0.02)
11,636
2,589
14,225
(1,266)
97
(1,169)
13,056
(3,244)
9,812
0.15
(0.02)
0.13
(0.01)
0.01
0.15
Discontinued operations
Diluted net income (loss) per share
Weighted average number of shares of common stock outstanding
– Basic
– Diluted
The accompanying notes are an integral part of these consolidated financial statements.
(0.01)
(0.02)
(0.03)
(0.02)
(0.02)
0.13
56,313,927
56,313,927
55,681,076
56,114,202
55,301,276
55,802,338
F-6
SINOVAC BIOTECH LTD.
Consolidated Statements of Shareholders’ Equity
For the years ended December 31, 2015, 2014 and 2013
(Expressed in thousands of U.S. dollars, expect for number of shares data)
Common stock
Shares
Amount
Additional
paid-in
capital
Balance, December 31, 2012
55,091,561 $
55
$ 106,246
Stock-based compensation (note 19)
Exercise of stock options (note 18)
Subscriptions received (note 18)
Other comprehensive income
- Other comprehensive income attributable to non-
controlling interests
- Other comprehensive income attributable to
shareholders
Net income for the year
-Net income attributable to non-controlling interests
- Net income attributable to shareholders of Sinovac
-
478,800
-
-
-
-
-
-
1
-
-
-
-
-
281
848
18
-
-
-
-
Accumulated
other
comprehensive
income (foreign
currency
translation
adjustment)
11,771
$
Statutory
surplus
reserves
11,808
$
Retained
earnings
Total
(accumulated shareholders’
Non-
controlling
deficit)
(12,156) $
equity
117,724
$
interests
11,711
$
Total
equity
$ 129,435
-
-
-
-
2,370
-
-
-
-
-
-
-
-
281
849
18
-
-
-
281
849
18
-
-
316
316
-
2,370
-
2,370
-
-
-
-
-
7,442
-
7,442
2,928
-
2,928
7,442
Balance, December 31, 2013
55,570,361 $
56 $ 107,393 $
14,141 $
11,808 $
(4,714) $
128,684 $
14,955 $ 143,639
The accompanying notes are an integral part of these consolidated financial statements.
F-7
SINOVAC BIOTECH LTD.
Consolidated Statements of Shareholders’ Equity
For the years ended December 31, 2015, 2014 and 2013
(Expressed in thousands of U.S. dollars, expect number of shares data)
Common stock
Shares
Amount
Additional
paid-in
capital
Balance, December 31, 2013
55,570,361 $
56
$ 107,393
Stock-based compensation (note 19)
Exercise of stock options (note 18)
Subscriptions received (note 18)
Other comprehensive loss
- Other comprehensive loss attributable to non-
controlling interests
- Other comprehensive loss attributable to shareholders
-
239,300
-
-
-
-
-
-
-
-
287
512
51
-
-
Net loss for the year
-Net income attributable to non-controlling interests
- Net (loss) attributable to shareholders of Sinovac
- Transfer to statutory surplus reserves (note 20)
Balance, December 31, 2014
-
-
-
55,809,661
-
-
-
56
-
-
-
108,243
Accumulated
other
comprehensive
income (foreign
currency
translation
adjustment)
14,141
$
-
-
-
-
(2,119)
-
-
-
12,022
Statutory
surplus
reserves
11,808
$
Total
Accumulated shareholders’
Non-
controlling
deficit
equity
$
(4,714) $
128,684
$
interests
14,955
Total
equity
$ 143,639
-
-
-
-
-
-
-
-
-
-
287
512
51
-
-
-
287
512
51
-
(308)
(308)
(2,119)
-
(2,119)
-
-
819
12,627
-
(851)
(819)
(6,384)
-
(851)
-
126,564
515
-
-
15,162
515
(851)
-
141,726
The accompanying notes are an integral part of these consolidated financial statements
F-8
SINOVAC BIOTECH LTD.
Consolidated Statements of Shareholders’ Equity
For the years ended December 31, 2015, 2014 and 2013
(Expressed in thousands of U.S. dollars, expect number of shares data)
Common stock
Shares
Amount
Additional
paid-in
capital
Balance, December 31, 2014
55,809,661 $
56
$ 108,243
Stock-based compensation (note 19)
Exercise of stock options (note 18)
Subscriptions received (note 18)
-
367,900
-
2015 restricted shares issued (note 18)
729,000
Other comprehensive loss
- Other comprehensive loss attributable to non-
controlling interests
- Other comprehensive loss attributable to shareholders
-
-
-
-
-
1
-
-
952
732
18
(1)
-
-
Accumulated
other
comprehensive
income (foreign
currency
translation
adjustment)
12,022
$
-
-
-
-
-
(3,912)
Statutory
surplus
reserves
12,627
$
Total
Accumulated shareholders’
Non-
controlling
deficit
equity
$
(6,384) $
126,564
$
interests
15,162
Total
equity
$ 141,726
-
-
-
-
-
-
-
-
-
-
-
-
952
732
18
-
-
-
-
-
-
952
732
18
-
(563)
(563)
(3,912)
-
(3,912)
Net loss for the year
-Net income attributable to non-controlling interests
- Net (loss) attributable to shareholders of Sinovac
- Transfer to statutory surplus reserves (note 20)
Balance, December 31, 2015
-
-
-
56,906,561
-
-
-
57
-
-
-
109,944
-
-
-
8,110
-
-
823
13,450
-
(1,074)
(823)
(8,281)
-
(1,074)
-
123,280
862
-
-
15,461
862
(1,074)
-
138,741
The accompanying notes are an integral part of these consolidated financial statements
F-9
SINOVAC BIOTECH LTD.
Consolidated Statements of Cash Flows
For the years ended December 31, 2015, 2014 and 2013
(Expressed in thousands of U.S. dollars)
Cash flows provided by (used in) operating activities
Income from continuing operations
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
- Deferred income taxes
- Stock-based compensation
- Inventory provision
- Provision (recovery) for doubtful accounts
- Loss on disposal and impairment of property, plant and equipment
- Depreciation of property, plant and equipment and amortization of licenses
- Amortization of prepaid land lease payments
- Government grants recognized in income
- Accretion expenses
Changes in:
- Accounts receivable
- Inventories
- Income tax payable
- Prepaid expenses and deposits
- Deferred revenue
- Accounts payable and accrued liabilities
- Other non-current liabilities
-Restricted cash
Net cash provided by (used in) operating activities from continuing operations
Net cash used in operating activities from discontinued operations
Net cash provided by (used in) operating activities
Cash flows provided by (used in) financing activities
- Proceeds from bank loans
- Repayments of bank loans
- Proceeds from issuance of common stock, net of share issuance costs
- Proceeds from shares subscribed
- Government grants received
- Repayment of loan from a non-controlling shareholder
Net cash provided by (used in) financing activities from continuing operations
Net cash provided by financing activities from discontinued operations
Net cash provided by (used in) financing activities
Cash flows used in investing activities
- Proceeds from disposal of equipment
- Acquisition of property, plant and equipment
- Proceeds from disposal of subsidiary
Net cash used in investing activities from continuing operations
Net cash used in investing activities from discontinued operations
Net cash used in investing activities
For the year ended December 31
2014
2015
2013
$
515 $
1,188
$
11,636
(518)
952
1,820
(49)
26
6,249
261
(1,637)
120
41
10
576
434
(3,639)
(434)
333
(1,677)
3,383
(722)
2,661
21,312
(46,786)
732
18
544
(16)
(24,196)
-
(24,196)
81
(5,299)
801
(4,417)
(98)
(4,515)
(162)
287
1,026
329
74
7,829
267
(104)
114
(9,691)
(6,130)
899
(506)
601
(3,999)
454
-
(7,524)
(1,123)
(8,647)
17,837
(15,962)
512
51
3,520
(649)
5,309
-
5,309
-
(10,913)
-
(10,913)
(90)
(11,003)
(2,225)
281
1,052
(504)
88
6,097
311
-
100
(7,256)
(7,157)
7
243
(675)
4,450
-
-
6,448
(872)
5,576
16,800
(4,089)
814
18
842
-
14,385
34
14,419
-
(5,133)
-
(5,133)
(43)
(5,176)
Effect of exchange rate changes on cash and cash equivalents, including cash classified
within current assets held for sale
(1,491)
(1,383)
1,182
Increase (decrease) in cash and cash equivalents, including cash classified within current
assets held for sale
(27,541)
(15,724)
Less: Net increase (decrease) in cash classified within current assets assets for sale
(82)
(500)
16,001
703
15,298
91,219
(27,459)
91,293
(15,224)
106,517
$
$
$
63,834 $
91,293 $
106,517
1,722 $
2,058 $
3,152
$
491 $
2,853
-
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning of year
Cash and cash equivalents, end of year
Supplemental disclosure of cash flow information:
Cash paid for interest
Cash paid for income taxes
Supplemental schedule of non-cash activities:
Acquisition of property, plant and equipment included in accounts payable and accrued
liabilities
The accompanying notes are an integral part of these consolidated financial statements
F-10
$
2,220 $
2,050 $
2,015
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
1.
Basis of Presentation
These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“US
GAAP”). They include the accounts of Sinovac Biotech Ltd., which is incorporated under the laws of Antigua and Barbuda, and its wholly owned or
controlled subsidiaries (collectively, the “Company”). All significant intercompany transactions have been eliminated. Details of the Company’s
subsidiaries are as follows:
Date of
incorporation or
establishment
Place of
incorporation
(or
establishment)
/operation
Percentage of
ownership as
of December
31, 2015
Percentage of
ownership as of
December 31, 2014
Name
Sinovac Biotech (Hong Kong) Ltd.
(“Sinovac Hong Kong”)
Sinovac Biotech Co., Ltd. (“Sinovac
Beijing”) (note 21)
October 2008
Hong Kong
100%
April 2001
People’s Republic of
China (“PRC”)
73.09%
Tangshan Yian Biological Engineering
Co., Ltd. (“Tangshan Yian”)
February 1993
Sinovac Biological Technology Co.,
Ltd. (“Sinovac R&D”)
Sinovac (Dalian) Vaccine Technology
Co., Ltd. (“Sinovac Dalian”) (note 21)
May 2009
January 2010
Sinovac Bitomed Co., Ltd.
April 2015
PRC
PRC
PRC
PRC
100%
100%
55%
100%
2.
Significant Accounting Policies
(a)
Use of Estimates
Principal activities
Investment holding company
Research and development,
production and sales of vaccine
products
Research and development,
production and sales of vaccine
products
Research and development of
vaccine products
Research and development,
production and sales of vaccine
products
100%
73.09%
100%
100%
55%
-
Distribution of vaccine
products
In preparation of the Company’s consolidated financial statements, management is required to make estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the
reported amounts of revenue and expenses during the reporting periods. Significant estimates made by management include: provision for
product returns, allowance for doubtful accounts, inventory provisions, useful lives of amortizable intangible assets, impairment of long-lived
assets, fair value of options granted and related forfeiture rates, and realizability of deferred tax assets. On an ongoing basis, management
reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it
becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future
activity, the Company’s consolidated financial statements could be materially impacted.
F-11
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(b)
Cash and Cash Equivalents
Cash equivalents consist of highly liquid investments that are readily convertible to cash generally with maturities of three months or less
when purchased.
(c)
Restricted Cash
Restricted cash is cash held as collateral for transactions the Company has entered into. As of December 31, 2015, the balance of $1,626
represents cash collateral held as a guarantee of an EPI (Expanded Programme on Immunization) sales contract which is restricted until
December 2016.
(d)
Accounts Receivable
The Company extends unsecured credit to its customers in the ordinary course of business and actively pursues past due accounts. The
Company estimates an allowance for doubtful accounts based on historical experience, the age of the accounts receivable balances, credit
quality of the Company’s customers, current economic conditions and other factors that may affect its customers’ ability to pay.
(e)
Inventories
Prior to January 1, 2015, inventories are stated at the lower of cost or replacement cost with respect to raw materials and the lower of cost or
market with respect to finished goods and work in progress. The Financial Accounting Standards Board (“FASB”) issued Accounting
Standards Update (“ASU”) No. 2015-11 (“ASU 2015-11”), Simplifying the Measurement of Inventory, which the Company adopted on
January 1, 2015. Subsequent to January 1, 2015, inventories are stated at the lower of cost or replacement cost with respect to raw materials
and the lower of cost or net realizable value with respect to finished goods and work in progress. The cost of work in progress and finished
goods is determined on a weighted-average cost basis and includes direct material, direct labor and overhead costs. Net realizable value
represents the anticipated selling price, net of distribution cost, less estimated costs to completion for work in progress.
(f)
Property, Plant and Equipment
Property, plant and equipment are recorded at cost. Significant additions and improvements are capitalized, while repairs and maintenance are
charged to expenses as incurred. Equipment purchased for specific research and development projects with no alternative uses are expensed.
Assets under construction are not depreciated until construction is completed and the assets are ready for their intended use. Gains and losses
from the disposal of property, plant and equipment are recorded in loss on disposal and impairment of property, plant and equipment included
in the consolidated statements of comprehensive income (loss).
F-12
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Depreciation of property, plant and equipment is computed using the straight-line method based on the estimated useful lives of the assets as
follows:
Plant and buildings
Machinery and equipment
Motor vehicles
Office equipment and furniture
Leasehold improvements
10 to 24 years
8 to 10 years
4 to 5 years
3 to 5 years
Lesser of useful lives and term of lease
(g)
Prepaid Land Lease Payments
Prepaid land lease payments represent amounts paid for the rights to use land in the PRC and is recorded at purchased cost less accumulated
amortization. Amortization is provided on a straight-line basis over the term of the lease agreement, which is 28 to 49 years.
(h)
Licenses
The Company capitalizes the patent payment and the purchased cost of vaccines if the vaccine has received a new drug certificate from the
China Food and Drug Administration (“CFDA”) of China. If the vaccine has not received a new drug certificate, the purchase cost is expensed
as in-process research and development.
Licenses in relation to the production and sales of pharmaceutical products are amortized on a straight-line basis over their respective useful
lives. The useful lives of inactivated hepatitis A and recombinant hepatitis A&B licenses are estimated to be ten years. Before August 15,
2012, the useful life for H5N1 licenses was estimated to be 20 years. Effective August 15, 2012, the remaining useful life was revised to three
years expiring on December 29, 2015 as a result of amendment to the agreement with the licensor (note 24(c)). The weighted average useful
lives of the acquired licenses are 9.16 years. Costs incurred to renew or extend the term of licenses are capitalized and amortized over the
license’s useful life on a straight-line basis.
(i)
Impairment of Long-Lived Assets
Long-lived assets including intangible assets subject to amortization are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying value of an asset group may not be recoverable from the future undiscounted net cash flows expected
to be generated by the asset group. An asset group is identified as assets at the lowest level for which identifiable cash flows are largely
independent of the cash flows of other assets. If the asset group is not fully recoverable, an impairment loss would be recognized for the
difference between the carrying value of the asset group and its estimated fair value, based on the discounted net future cash flows or other
appropriate methods, such as comparable market values. The Company uses estimates and judgments in its impairment tests and if different
estimates or judgment had been utilized, the timing or the amount of any impairment charges could be materially different. The Company
recorded impairment charges on long-lived assets for the year ended December 31, 2015 of $nil (2014 - $nil, 2013 - $57).
(j)
Income Taxes
The Company follows the liability method of accounting for income taxes. Under this method, deferred tax liabilities and assets are
determined based on the temporary differences between the carrying values and tax bases of assets and liabilities using enacted tax rates in
effect in the years in which the differences are expected to reverse. A valuation allowance is provided if, based on the weight of available
evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. Deferred tax assets and liabilities
are measured using enacted tax rates and laws.
F-13
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The tax benefit from an uncertain tax position is recognized only if it is more likely than not that the tax position will be sustained upon
examination by the appropriate taxing authority, based on the technical merits of the position. The tax benefits recognized from such a position
are measured based on the amount that is greater than 50% likely of being realized upon settlement. The Company recognizes a change in
available facts after the reporting date but before issuance of the financial statements in the period when the change in facts occur, even if that
new information provides a better estimate of the ultimate outcome of an uncertainty. Liabilities associated with uncertain tax positions are
classified as long−term unless expected to be paid within one year. Interest and penalties related to uncertain tax positions, if any, are recorded
in the provision for income taxes and classified with the related liability on the consolidated balance sheets.
(k)
Value-added Taxes
Value-added taxes (“VAT”) collected from customers relating to product sales and remitted to governmental authorities are presented on a net
basis. VAT collected from customers is excluded from revenue. Prior to July 1, 2014, the Company was subject to a VAT rate of 6%. Starting
on July 1, 2014, the Company is subject to a VAT rate of 3%.
(l)
Revenue Recognition
Revenue is recognized when persuasive evidence of an arrangement exists, the price is fixed and determinable, delivery has occurred and
there is a reasonable assurance of collection of the sales proceeds. The Company generally obtains purchase authorizations from its customers
for a specified amount of products at a specified price and considers delivery to have occurred when the customer takes title of the products.
The Company provides certain customers with a right of return.
Revenue for inactivated hepatitis A, combined inactivated hepatitis A&B and seasonal influenza vaccines are recognized when delivery has
occurred and the Company estimates return provision for these products. The product return provisions for inactivated hepatitis A vaccine and
combined inactivated hepatitis A&B vaccine are estimated based on historical return and exchange levels as well as the inventory levels and
the remaining shelf lives of the products in the distribution channels. As of December 31, 2015, the sales return provision for inactivated
hepatitis A vaccine and combined inactivated hepatitis A&B vaccine was $5,900 (December 31, 2014 - $3,553). Private pay sales return
provision of inactivated hepatitis A and combined inactivated hepatitis A&B as a percentage of sales was 13.6% and 8.6% in 2015 and 2014,
respectively. The Company does not accept returns for hepatitis products sold under the Expanded Program on Immunization and exports. As
such, no sales returns are estimated for these sales. The product return provision for seasonal influenza vaccines is estimated based on actual
sales returns and expected sales returns up to the end of the flu season because the Company generally accepts returns before the end of the flu
season. As of December 31, 2015, the sales return provision for seasonal influenza vaccine returns was approximately $1,462 (December 31,
2014 - $1,320).
F-14
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Revenue for animal and mumps vaccines without a right of return provided to customers is recognized when delivery has occurred. Revenue
for animal and mumps vaccines with a right of return provided to customers is recognized when payments are collected from customers as the
Company currently does not have sufficient historical data to estimate returns for these products.
Deferred revenue is generally related to government stockpiling programs and advances received from customers. For government stockpiling
programs of H5N1 vaccines, the Company generally obtains purchase authorizations from the government for a specified amount of products
at a specified price and no rights of return are provided. Revenue is recognized when the government takes delivery of the products. If the
products expire prior to delivery, these expired products are recognized as revenue once cash is received and the products have expired and
passed government inspection.
(m)
Shipping and Handling
Shipping and handling fees billed to customers are included in sales. Costs related to shipping and handling are recognized in selling, general
and administrative expenses in the consolidated statements of comprehensive income (loss). For the year ended December 31, 2015, $1,389 of
shipping and handling costs was included in selling, general and administrative expenses (2014 - $1,235, 2013 - $1,215).
(n)
Advertising Expenses
Advertising costs are expensed as incurred and included in selling, general and administrative expenses. Advertising costs were $851 for the
year ended December 31, 2015 (2014 - $268, 2013 - $474).
(o)
Research and Development
Research and development ("R&D") costs are expensed as incurred and are disclosed as a separate line item in the Company’s consolidated
statements of comprehensive income (loss). R&D costs consist primarily of the remuneration of R&D staff, depreciation, material, clinical
trial costs as well as amortization of acquired technology and know-how used in R&D with alternative future uses. R&D costs also include
costs associated with collaborative R&D and in-licensing arrangements, including upfront fees paid to collaboration partners in connection
with technologies which have not reached technological feasibility and did not have an alternative future use. Reimbursement of R&D costs
for arrangements with collaboration partners is recognized when the obligations are incurred.
Under certain R&D arrangements with third parties, the Company may be required to make payments that are contingent on the achievement
of specific development, regulatory and/or commercial milestones. Before a product receives regulatory approval, license fees and milestone
payments made to third parties are expensed as incurred. License fees and milestone payments made to third parties after regulatory approval
is received are capitalized and amortized over the remaining life of the agreement with third parties.
F-15
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(p)
Government Grants
Government grants received from the PRC government by the PRC operating subsidiaries of the Company are recognized when there is
reasonable assurance that the amount is receivable and all the conditions specified in the grant have been met. Government grants for R&D are
recognized as a reduction to R&D expenses when the expenses are incurred in the same period when the conditions attached to the grants are
met, or recognized as government grants recognized in income in the period when the conditions are met after the expenses are incurred.
Government grants for property, plant and equipment are deferred and recognized as a reduction to the related depreciation and amortization
expenses in the same manner as the property, plant and equipment are depreciated. Interest subsidies are recorded as a reduction to interest and
financing expenses in the consolidated statements of comprehensive income (loss), or recorded as a reduction to interest capitalized if the
subsidies granted are related to a specific borrowing associated with building a qualifying asset. For government loans received at below
market interest rate, the difference between the face value of the loan and fair value using the effective interest rate method is recorded as
deferred government grants. Accretion expense is recorded in interest and financing expense and the government grant will be recognized as
“government grants recognized in income” in the consolidated statement of comprehensive income (loss) when the government loan is fully
repaid.
(q)
Retirement and Other Post-retirement Benefits
Full-time employees of the Company in the PRC participate in a government mandated defined contribution plan pursuant to which certain
pension benefits, medical care, unemployment insurance, employee housing fund and other welfare benefits are provided to employees.
Chinese labor regulations require that the Company makes contributions to the government for these benefits based on certain percentages of
the employees’ salaries. The Company has no legal obligation for the benefits beyond the contributions. The total amounts for such employee
benefits, which were expensed as incurred was $3,577 for the year ended December 31, 2015 (2014 - $3,338, 2013 - $3,083).
(r)
Foreign Currency Translation and Transactions
The Company maintains their accounting records in their functional currencies, U.S. dollars (“US$”) for the Company and Sinovac Hong
Kong and Renminbi Yuan (“RMB”) for the PRC subsidiaries. The Company uses the US$ as its reporting currency.
At the transaction date, each asset, liability, revenue and expense is re-measured into the functional currency by the use of the exchange rate in
effect at that date. At each period end, foreign currency monetary assets, and liabilities are re-measured into the functional currency by using
the exchange rate in effect at the balance sheet date. The resulting foreign exchange gains and losses are included in selling, general and
administrative expenses. The Company recognized foreign exchange gains (losses) of $(886) for the year ended December 31, 2015 (2014 -
$(619), 2013 - $650).
F-16
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The assets and liabilities of the PRC subsidiaries, Sinovac Beijing, Tangshan Yian, Sinovac R&D, Sinovac Dalian and Sinovac Bitomed are
translated into US$ at the exchange rates in effect at the balance sheet date. Revenue and expenses are translated at average exchange rates.
Gains and losses from such translations are recorded in accumulated other comprehensive income, a component of shareholders’ equity.
Gains and losses on intra-entity foreign currency transactions that are of a long-term-investment nature was $560 for year ended December 31,
2015 (2014 - $294, 2013 - $235) which was recorded in accumulated other comprehensive income, a component of shareholders’ equity.
(s)
Stock-based Compensation
Compensation expense for costs related to all share-based payments, including grants of stock options, is recognized through a fair-value
based method. The Company uses the Black-Scholes option-pricing model to determine the grant date fair value for stock options. The
Company uses the grant date stock price to determine the grant date fair value of restricted shares. The Company has elected to recognize
share-based compensation costs using the straight-line method over the requisite service period with a graded vesting schedule, provided that
the amount of compensation costs recognized at any date is at least equal to the portion of the grant date value of the awards that are vested at
that date. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from initial
estimates. Share based compensation costs are recorded net of estimated forfeitures such that expense is recorded only for those awards that
are expected to vest.
(t)
Comprehensive Income (loss)
The Company’s comprehensive income (loss) consists of net income (loss) and foreign currency translation adjustments.
(u)
Earnings (loss) Per Share
Earnings (loss) per share is calculated in accordance with Accounting Standards Codification (“ASC”) 260 Earnings per Share. Basic
earnings (loss) per share is computed by dividing the net income (loss) attributable to shareholders of Sinovac by the weighted average
number of common shares outstanding during the year. Diluted earnings per share is computed in accordance with the treasury stock method
and based on the weighted average number of common shares and dilutive common share equivalents. Dilutive common share equivalents are
excluded from the computation of diluted earnings per share if their effects would be anti-dilutive.
(v)
Operating Leases
Leases are classified as capital and operating depending on the terms and conditions of the lease agreement. Leases that transfer substantially
all the benefits and risks incidental to ownership of assets are accounted for as if there was an acquisition of an asset and incurrence of an
obligation at the inception of the lease. All other leases are accounted for as operating leases where rental payments are expensed as incurred.
There are no capital leases for the periods presented.
F-17
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(w)
Fair Value Measurements
Assets and liabilities subject to fair value measurements are required to be disclosed within a specified fair value hierarchy. The fair value
hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities
carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a
particular fair value measurement:
Level 1 — Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 2 inputs include quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets and
liabilities in markets that are not active.
Level 3 — Unobservable inputs for the asset or liability.
As of December 31, 2015 and 2014, the Company did not have any financial assets or liabilities measured at fair value on a recurring basis.
The carrying values of cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities and short-term bank
loans and the current portion of long-term debt approximate their fair value because of their short-term nature. The fair values of long-term
bank loans and other debt are estimated based on the discounted value of future contractual cash flows which approximates their carrying
value due to the fact they are predominately stated at variable rates based on the People’s Bank of China. Fair value of the long-term bank
loans and other debt are determined based on level 2 inputs.
The Company measures property, plant and equipment at fair value on a non-recurring basis only if an impairment charge were to be
recognized. There were no non-recurring fair value measurements for the years ended December 31, 2015 and 2014.
(x)
Concentration of Risks
Exchange Rate Risks
The Company operates in China, which may give rise to significant foreign currency risks from fluctuations and the degree of volatility of
foreign exchange rates between the US$ and the RMB. In 2015, foreign exchange gains (losses) of $(886) is included in selling, general and
administrative expenses (2014- $(619), 2013 - $650). As at December 31, 2015, cash and cash equivalents of $46,923 (RMB 304 million) is
denominated in RMB and are held in PRC and Hong Kong (December 31, 2014 - $71,968 (RMB 447 million)).
Currency Convertibility Risks
Substantially all of the Company’s operating activities are transacted in RMB, which is not freely convertible into foreign currencies. All
foreign exchange transactions take place either through the People’s Bank of China or other banks authorized to buy and sell foreign
currencies at the exchange rates quoted by the People’s Bank of China. Approval of foreign currency payments by the People’s Bank of China
or other regulatory institutions requires submitting a payment application form together with other information such as suppliers’ invoices,
shipping documents and signed contracts.
F-18
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Concentration of Credit Risks
Financial instruments that potentially subject the Company to concentration of credit risks consist primarily of cash and cash equivalents,
restricted cash and accounts receivable, the balances of which are stated on the consolidated balance sheets which represent the Company’s
maximum exposure. The Company places its cash and cash equivalents and restricted cash in good credit quality financial institutions in Hong
Kong and China. Concentration of credit risks with respect to accounts receivables is linked to the concentration of revenue. The Company’s
customers are mainly various government agencies in China. For the year ended December 31, 2015, one of the Company’s customers
accounted for 14% of the Company’s total revenue. No single customer accounted for more than 10% of total sales for the years ended
December 31, 2014 and 2013 except for government stockpile purchases revenue recognized in 2013. To manage credit risk, the Company
performs ongoing credit evaluations of customers’ financial condition.
Interest Rate Risks
The Company is subject to interest rate risk. Other than a loan with carrying value of $1,861 and loan from a non-controlling shareholder of
$2,470 with fixed interest rates as at December 31, 2015, other interest-bearing loans are charged interest at variable rates based on the
People’s Bank of China (note 11).
(y)
Recently Issued Accounting Standards
In May 2014, the FASB issued ASU No. 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers (Topic 606), where a single,
global revenue recognition model applies to most contracts with customers. Revenue will be recognized in a manner that depicts the transfer
of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled, subject to certain
limitations. In August 2015, the FASB issued ASU 2015-14, where the effective date of ASU 2014-09 was extended to annual periods
beginning after December 15, 2018. The Company is currently evaluating the impact on its consolidated financial statements of adopting this
standard.
In August 2014, the FASB issued ASU No. 2014-15 (“ASU 2014-15”), Going Concern. Management of the Company will be required to
evaluate whether there is substantial doubt about the Company’s ability to continue as a going concern and, if so, disclose that fact.
Management will also be required to evaluate and disclose whether its plans alleviate that doubt. The guidance is effective for annual periods
beginning after December 15, 2016. Early adoption is permitted. The Company will adopt ASU 2014-15 on January 1, 2017, and does not
expect the adoption of this standard will have a material impact on its consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30) (“ASU 2015-03”). The guidance would
require that debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the
carrying amount of debt liability, consistent with debt discounts or premiums, rather than an asset. ASU 2015-03 is effective for annual
reporting periods beginning after December 15, 2015, including interim periods within that reporting period. Early adoption is permitted. The
Company is currently evaluating the impact, if any, of the adoption of ASU 2015-03 on its consolidated financial statements.
F-19
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
In November 2015, the FASB issued ASU No. 2015-17 (“ASU 2015-17”), Income Taxes. To simplify the presentation of deferred income
taxes, ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position,
applicable to all entities that present a classified statement of financial position. The guidance is effective for annual periods beginning after
December 15, 2016. Early adoption is permitted. While the Company is still assessing the impact on its consolidated financial statements of
adopting this standard, it does not believe that the adoption of this guidance will have a material impact on its consolidated financial
statements.
In January 2016, the FASB issued ASU No. 2016-01 (“ASU 2016-01”), Financial Instruments. ASU 2016-01 requires separate presentation of
financial assets and financial liabilities by measurement category and form of financial asset on the balance sheet or in the accompanying
notes to the financial statements. That presentation provides financial statement users with more decision-useful information about an entity’s
involvement in financial instruments. The guidance is effective for annual periods beginning after December 15, 2017. Early adoption is
permitted. The Company is currently evaluating the impact on its consolidated financial statements of adopting this standard.
In February 2016, the FASB issued ASU No. 2016-02 (“ASU 2016-02”), Leases. ASU 2016-02 requires recognition of lease assets and lease
liabilities by lessees for those leases classified as operating leases. The guidance is effective for annual periods beginning after December 15,
2018. Early adoption is permitted. The Company is currently evaluating the impact on its consolidated financial statements of adopting this
standard.
In March 2016, the FASB issued ASU No. 2016-09 (“ASU 2016-09”), Compensation – Stock Compensation. Under ASU 2016-09, the
Company can make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for
forfeitures when they occur. The guidance is effective for annual periods beginning after December 15, 2016. Early adoption is permitted. The
Company is currently evaluating the impact on its consolidated financial statements of adopting this standard.
3.
Discontinued Operations
In December 2015, the Company committed to a plan to sell 100% of their equity stake in Tangshan Yian Biological Engineering Co., Ltd. (“Tangshan
Yian”) to an unrelated third-party biological technology company, for a total consideration of $2,069 (RMB 13 million). As of December 31, 2015, the
Company received $776 (RMB 5.03 million) and the closing of the sale was subject to the fulfillment of several conditions. For disposal transactions
that occur on or after January 1, 2015, a component of the Company is reported in discontinued operations after meeting the criteria for held-for-sale
classification if the disposition represents a strategic shift that has (or will have) a major effect on the Company’s operations and financial results. The
Company analyzed the quantitative and qualitative factors relevant to Tangshan Yian disposition transaction and determined the criteria for held-for-
sale classification have been met, and the transaction represents a strategic shift where the Company is exiting the animal vaccine market and will focus
on the human use vaccine market, which will have a major effect on the Company’s operations and financial results going forward. As such, the
financial results of Tangshan Yian are reported within discontinued operations in the consolidated financial statements. The consolidated financial
statements and amounts previously reported have been reclassified, as necessary, to conform to this presentation in accordance with ASC 205,
Presentation of Financial Statements to allow for meaningful comparison of continuing operations.
F-20
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Results of the discontinued operations are summarized as follows:
Sales
Cost of sales
Gross loss
Selling, general and administrative expenses
Research and development expenses
Total operating expenses
Operating (loss)
Other income (expense)
(Loss) before income taxes
Income tax benefit (expense)
(Loss) from discontinued operations, net of income tax
2015
For the year ended December 31,
2013
2014
112 $
406
(294)
459
22
481
(775)
47
(728)
-
(728) $
$
169
1,017
(848)
621
100
721
(1,569)
45
(1,524)
-
(1,524) $
750
768
(18)
927
256
1,183
(1,201)
(65)
(1,266)
-
(1,266)
$
$
The following table summarizes the carrying amounts of the major classes of assets and liabilities held for sale in the consolidated balance sheets as of
December 31, 2015 and 2014, respectively:
Cash and cash equivalents
Prepaid land lease payments
Property, plant and equipment
Other assets held for sale
Total assets held for sale
Accounts payable and accrued liabilities
Other liabilities held for sale
Total liabilities held for sale
December 31,
2015
143 $
128
1,450
76
1,797
December 31,
2014
225
144
2,184
162
2,715
217
26
243 $
699
28
727
$
$
F-21
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
In February 2016, the Company completed the disposal of Tangshan Yian (note 25).
4.
Restricted Cash
As of December 31, 2015, the balance of $1,626 (December 31, 2014 - nil) represents cash collateral for guarantee of an EPI sales contract, which is
restricted until December 2016.
Restricted Cash
5.
Accounts Receivable – net
Trade receivables (note 11)
Allowance for doubtful accounts
Other receivables
Total accounts receivable
December 31, December 31,
2014
-
2015
1,626 $
$
December 31,
2015
40,733 $
(2,415)
38,318
703
39,021 $
December 31,
2014
42,423
(2,571)
39,852
867
40,719
$
$
Accounts receivables with a carrying value of $5,403 (RMB 35 million) were pledged as collateral for a bank loan from China Merchant Bank as of
December 31, 2015 (note 11).
Accounts receivables with a carrying value of $5,641 (RMB 35 million) were pledged as collateral for a bank loan from Industrial and Commercial
Bank of China as of December 31, 2014 (note 11).
The allowance for doubtful accounts reflects the Company’s best estimate of probable losses inherent in the accounts receivable balance. The Company
estimates the allowance based on known troubled accounts, historical experience, the age of the accounts receivable balances, credit quality of the
Company’s customers, current economic conditions, and other factors that may affect customers’ ability to pay. The Company records its allowance for
doubtful accounts based upon its assessment of various factors. As of December 31, 2015, the Company provided 100% (December 31, 2014 -100%)
allowance for accounts receivable aged more than four years, approximately 71.3% (December 31, 2014 - 100%) allowance for accounts receivable
aged between three years and four years, approximately 38.6% (December 31, 2014 - 56.3%) allowance for accounts receivable aged between two
years and three years, approximately 13.6% (December 31, 2014 - 18.5%) allowance for accounts receivable aged between one year and two years, and
approximately 1.4% (December 31, 2014 - 1.8%) allowance for accounts receivable aged less than one year.
For the year ended December 31, 2015, the Company changed its estimates of the allowance for doubtful accounts due to an improved historical trend
of collecting accounts aged three years or more. The change in estimate resulted in an increase to income from continuing operations and net income
attributable to shareholders of Sinovac of $375 and $274, respectively. In addition, basic and diluted earnings per share increased by $0.00 and $0.00,
respectively.
F-22
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The Company’s maximum exposure to credit risk at the balance sheets date relating to trade receivables is summarized as follows:
Aging within one year, net of allowance for doubtful accounts
Aging greater than one year, net of allowance for doubtful accounts
Total trade receivables
6.
Inventories
Raw materials
Work in progress
Finished goods
Inventories
December 31,
2015
34,495 $
December 31,
2014
35,130
3,823
38,318 $
4,722
39,852
$
$
December 31, December 31,
2014
2,603
4,056
12,053
18,712
2015
2,450 $
3,636
12,599
18,685 $
$
$
For the year ended December 31, 2015, the Company charged $2,154 of excessive fixed production overhead to cost of sales (2014 - $1,764, 2013 -
$1,790).
For the year ended December 31, 2015, the cost of sales includes $1,820 of inventory provision for products that are likely to expire before being sold
(2014 - $1,026, 2013 - $1,052).
7.
Long-term Inventories
Work in progress
Finished goods
Long-term Inventories
December 31,
2015
- $
-
- $
December 31,
2014
-
2,648
2,648
$
$
Long-term inventories represent H5N1 vaccines with remaining shelf lives over one year and not expected to be sold within one year. These vaccines
are for government stockpiling purposes.
F-23
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
8.
Property, Plant and Equipment
Cost
Construction in progress
Plant and buildings
Machinery and equipment
Motor vehicles
Equipment and furniture
Leasehold improvements
Total cost
Less: Accumulated depreciation
Construction in progress
Plant and buildings
Machinery and equipment
Motor vehicles
Equipment and furniture
Leasehold improvements
Total accumulated depreciation
Property, plant and equipment, net
December 31,
2015
December 31,
2014
$
$
$
$
$
13,256
30,852
39,700
1,570
2,566
12,911
100,855
-
8,059
20,458
1,408
1,830
5,160
36,915
63,940
$
$
$
$
$
8,206
32,211
40,596
1,747
2,542
13,232
98,534
-
6,957
17,876
1,567
1,707
4,194
32,301
66,233
The buildings of the Changping facilities of Sinovac Beijing with a net book value of $13,505 (RMB 87.5 million) were pledged as collateral for a
bank loan from China Construction Bank (note 11).
The buildings of Sinovac Beijing with a net book value of $2,568 (RMB 16.6 million) were pledged as collateral for a bank loan from Bank of Beijing
(note 11).
The buildings of Sinovac Dalian with a net book value of $5,344 (RMB 34.6 million) were pledged as collateral for a bank loan from Bank of China
(note 11).
Depreciation expense for the year ended December 31, 2015 was $5,897 (2014 - $7,458, 2013 - $5,662).
Loss on disposal of equipment for the year ended December 31, 2015 was $26 (2014 - $74, 2013 - $31).
9.
Prepaid Land Lease Payments
Prepaid land lease payments
Less: accumulated amortization
Net carrying value
December 31,
2015
December 31,
2014
$
$
11,147 $
1,573
9,574 $
11,638
1,377
10,261
F-24
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The prepaid land lease payments of the Changping facilities of Sinovac Beijing with a net book value of $2,724 (RMB17.6 million) were pledged as
collateral (note 11) for a bank loan from China Construction Bank.
The prepaid land lease payments of Sinovac Beijing with a net book value of $327 (RMB2.1 million) were pledged as collateral (note 11) for a bank
loan from Bank of Beijing.
The prepaid land lease payments of Sinovac Dalian with a net book value of $3,548 (RMB23.0 million) were pledged as collateral (note 11) for a bank
loan from Bank of China.
Amortization expense for prepaid land lease payments for the year ended December 31, 2015 was $261 (2014 - $267, 2013 - $311).
10.
Licenses
Inactivated hepatitis A
Combined inactivated hepatitis A&B
H5N1 licenses (note 24(c))
Total
Inactivated hepatitis A
Combined inactivated hepatitis A&B
H5N1 licenses (note 24(c))
Total
$
$
$
$
$
December 31, 2015
Accumulated
amortization
3,261
470
1,419
5,150 $
$
Cost
3,261
470
1,419
5,150 $
December 31, 2014
Accumulated
amortization
$
3,405
490
1,130
5,025 $
$
Cost
3,405
490
1,482
5,377 $
Net book
value
-
-
-
-
Net book
value
-
-
352
352
On August 15, 2011, the Company entered into a non-exclusive main license agreement together with three sublicense agreements with Medimmune,
LLC (“Medimmune”) to use patented reverse genetics technology pertaining to virus strain production for vaccines, including the H5N1 influenza
virus strain. The Company amortized the patent fee on a straight-line method basis over the estimated useful life of 20 years. On August 15, 2012, the
Company entered into amendment agreements with Medimmune which amended the term of the license agreements. As for the main license
agreement, the estimated useful life of the patent was revised to end on December 29, 2015. Accordingly, the estimated useful life of the patent was
revised to end on December 29, 2015 (note 24(c)) which is the termination date of the main license agreement, hence the H5N1 licenses fee was fully
amortized as of December 31, 2015.
F-25
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Amortization expense for the licenses was $352 for the year ended December 31, 2015 (2014 - $371, 2013 - $435).
11.
Bank Loans and Other Debt
Summarized below are bank loans and other debt as of December 31, 2015 and 2014:
China Merchants Bank (a)
Bank of Beijing (b)
Bank of China (c)
China Merchants Bank (d)
Industrial and Commercial Bank of China (d)
China Construction Bank (e)
Bank loans due within one year
China Construction Bank (f)
China Construction Bank (g)
Bank of Beijing (h)
Beijing Zhongguancun Development Group (i)
Current portion of long-term bank loans and other debt
Bank of Beijing (h)
Beijing Zhongguancun Development Group (i)
Long-term bank loans and other debt
Total bank loans and other debt
$
December 31,
2015
2014
$
4,631
2,933
1,544
3,087
-
7,719
19,914
-
-
-
1,861
1,861
756
-
756
4,835
8,059
1,612
-
3,223
-
17,729
13,861
4,044
11,741
-
29,646
-
1,803
1,803
$
22,531
$
49,178
(a) In 2014, Sinovac Beijing entered into a bank loan with China Merchants Bank in the aggregate principal amount of $4,835 (RMB 30 million) to
finance its working capital requirements, bearing interest at 15% above the prime rate of a one-year term loan published by the People’s Bank of China,
at 6.9% per year. Interest was payable quarterly. The loan was drawn on March 3, 2014 and was repaid on March 2, 2015.
In 2015 Sinovac Beijing entered into a new bank loan with China Merchants Bank in the aggregate principal amount of $4,631 (RMB 30 million) to
finance its working capital requirements bearing interest at 15% above the prime rate of a one-year term loan published by the People’s Bank of China,
at 5.58% per year. Interest is payable quarterly. The loan was drawn on June 30, 2015 and is repayable on June 28, 2016.
F-26
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(b) In 2014, Sinovac Beijing entered into a bank loan with Bank of Beijing in the aggregate principal amount of $8,059 (RMB 50 million) to finance its
working capital requirements. The loan’s annual interest rate was 6% and was payable quarterly. The loan was drawn on August 28, 2014 and was
repaid in full on August 28, 2015.
On September 18, 2015, Sinovac Beijing entered into a bank loan with Bank of Beijing in the aggregate principal amount of $7,719 (RMB 50 million)
to finance its working capital requirements. The loan bears interest at 4.35% and is payable quarterly. The first $1,467 (RMB 9.5 million) was drawn
on October 28, 2015 and is repayable on October 27, 2016. The second $1,466 (RMB 9.5 million) was drawn on November 30, 2015 and is repayable
on November 29, 2016.
(c) On December 17, 2012, Sinovac Dalian entered into a bank loan agreement with Bank of China with a credit line of $3,223 (RMB 20 million). The
loan’s annual interest rate was 7.44%. The first $806 (RMB 5 million) was drawn down on March 13, 2013 and repaid on March 12, 2014. The second
$806 (RMB 5 million) was drawn down on September 24, 2013 and repaid on September 23, 2014. The third $806 (RMB 5 million) was drawn down
on March 31, 2014 and was repaid on March 26, 2015. The fourth $806 (RMB 5 million) was drawn down on September 23, 2014 and was repaid in
full on September 22, 2015.
On March 17, 2015, Sinovac Dalian entered into a bank loan with Bank of China in the aggregate principal amount of $772 (RMB 5 million) to finance
its working capital requirements. The loan bears interest at 30% above the prime rate of a one-year term loan published by the People’s Bank of China,
at 6.955%, the interest is paid monthly, and the loan will be repaid on March 16, 2016. On October 26, 2015, Sinovac Dalian entered into a bank loan
with Bank of China in the aggregate principal amount of $772 (RMB 5 million) to finance its working capital requirements. The loan bears interest at
166 base points above the prime rate of a one-year term loan published by the People’s Bank of China, at 6.01%, interest is paid monthly and the loan
is repayable on October 26, 2016. Prepaid land lease payments and buildings of Sinovac Dalian with a net book value of $8,892 (RMB 57.6 million)
were pledged as collateral.
(d) In 2014, Sinovac Beijing entered into a bank loan with Industrial and Commercial Bank of China in the aggregate principal amount of $3,223
(RMB 20 million) to finance its working capital requirements, bearing interest at 10% above the prime rate of a one-year term loan published by the
People’s Bank of China at 7.5% per year. Interest was payable monthly. The loan was drawn on June 19, 2014, and guaranteed by an unrelated third
party, with a guarantee fee of $64 (RMB 0.4 million) over the term of the loan. Trade receivables of Sinovac Beijing with a carrying value of not lower
than $5,641 (RMB 35 million) were pledged as collateral. The loan was fully repaid on June 30, 2015.
On November 5, 2015, Sinovac Beijing entered into a one-year term bank loan with China Merchants Bank in the aggregate principal amount of
$3,087 (RMB 20 million) to finance its working capital requirements, bearing interest at 5% above the prime rate of a one-year term loan published by
the People’s Bank of China, at 4.57% per year. Interest is payable quarterly. The loan is guaranteed by an unrelated third party, with a guarantee fee of
$62 (RMB 0.4 million) over the term of the loan. Trade receivables of Sinovac Beijing with a carrying value of not lower than $5,403 (RMB 35
million) were pledged as collateral.
F-27
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(e) On June 4, 2015, Sinovac Beijing entered into a bank loan with China Construction Bank in the aggregate principal amount of $7,719 (RMB50
million) to finance its working capital requirements, bearing interest at 5% above the prime rate of a one-year term loan published by the People’s
Bank of China and the interest rate of current year is 5.36%. Interest is payable monthly. The loan was drawn by three installments on June 4, 2015,
June 29, 2015, and August 7, 2015, and is repayable on June 3, 2016. Pursuant to the covenants set out in the agreement, the debt to total assets ratio
must not be higher than 80%, the current ratio must not be lower than 0.8, contingent liabilities must not be higher than $24,830 (RMB 161 million)
and contingent liabilities as a percentage of total shareholders’ equity must not be higher than 50%. The Company is in compliance with such
covenants as of December 31, 2015.Prepaid land lease payment and buildings of the Changping facilities of Sinovac Beijing with a net book value of
$16,229 (RMB 105.1 million) were pledged as collateral.
(f) The loan from China Construction Bank in the aggregate principal amount of $13,894 (RMB 90 million) was exclusively for the purchase of the
Changping facility, bearing interest at the bank’s prime lending rate and adjusted every 12 months, at 6.4% per year. Interest was payable monthly.
Prepaid land lease payment and buildings of the Changping facilities of Sinovac Beijing with a net book value of $17,798 (RMB 110 million) were
pledged as collateral. $322 (RMB 2 million) was repaid in 2013, $322 (RMB 2 million) was repaid in 2014, and the remaining $13,861 (RMB 86
million) was fully repaid in 2015.
(g) The total amount of the loan facility from China Construction Bank was $8,059 (RMB 50 million) for a three-year period from December 13, 2012
to December 12, 2015. The amount drawn was $4,996 (RMB 31 million) as at December 31, 2014. Interest was set at the bank’s prime lending rate at
6.15% per year. The loan was to be used exclusively for the operation and production costs of Sinovac Beijing. Interest was payable monthly. The loan
was unsecured. 10% of the principal amount was repayable in 2013 and 10% of the principal amount was repayable in 2014 with the remaining
principal repayable in 2015. $458 (RMB 3 million) was repaid in 2013 and $494 (RMB 3 million) was repaid in 2014, and the remaining $3,874 (RMB
25 million) was fully repaid in 2015.
(h) The loan from Bank of Beijing in the aggregate principal amount of $23,531 (RMB 146 million) with a term from May 2011 to November 2015
was for construction of the Changping facility and had a maximum credit facility amount of $32,234 (RMB 200 million). The interest was charged at
the bank’s prime lending rate and adjusted every 12 months, at 6.4% per year, and was payable quarterly. The loan was repayable in four installments
on May 13, 2014, November 13, 2014, May 13, 2015 and November 13, 2015. $11,790 (RMB 72.6 million) was repaid in 2014 and $11,741 (RMB
72.9 million) was repaid in 2015. Prepaid land lease payments and buildings of Sinovac Beijing with a net book value of $3,285 (RMB 20.4 million)
were pledged as collateral as of December 31, 2014.
F-28
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
On May 20, 2015, Sinovac Beijing entered into a new bank loan with Bank of Beijing in the aggregate principal amount of $7,410 (RMB 48 million)
with a term from July 2015 to July 2020 for construction of the pneumococcal polysaccharide vaccine facilities. The loan bears interest at the bank’s
prime lending rate, at 5.25% per year. Interest is payable quarterly. The loan is repayable in four equal installments in January 2019, July 2019, January
2020 and July 2020. $756 (RMB 4.9 million) was drawn in July 2015. Prepaid land lease payments and buildings of Sinovac Beijing with a net book
value of $2,896 (RMB 18.8 million) were pledged as collateral as of December 31, 2015.
(i) The Loan from Beijing Zhongguancun Development Group in the aggregate principal amount of $1,934 (RMB 12 million) bearing interest currently
at 0.36% per year is for the purpose of funding the EV71 vaccine research project of Sinovac Beijing. The total loan is $1,934 (RMB 12 million) of
which $967 (RMB 6 million) was received in 2012 and the second $967 (RMB 6 million) was received in 2013. The loan is unsecured and repayable
on February 24, 2016. Beijing Zhongguancun Development Group is entitled to 10.62% ownership of the profits, if any, generated from the intellectual
property developed during the loan period. No profit-sharing payments are required to be made as no profits have been generated to date. The
Company can repay the loan at any time during the loan period. The fair value differential of $358 (between the face value and the fair value using the
effective interest rate method at the Company's borrowing rate of 6.9%) is recorded as a current deferred government grant as of December 31, 2015
(2014- $376) (see note 16). The loan was repaid in full on February 22, 2016.
Aggregate annual principal payments of loans payable as of December 31, 2015 are as follows:
Within 1 year
More than 1 year
Total
$
$
21,775
756
22,531
The weighted average effective interest rate for all short-term and loan-term bank loans was 6.0% in 2015 (2014 - 6.8%, 2013 - 6.6%). The weighted
average interest rate for short-term loans was 6.0% in 2015 (2014 - 6.8%, 2013 - 7.0%). The Company incurred $2,059 in interest and financing
expenses for the year ended December 31, 2015 (2014 - $3,374, 2013 - $2,942), of which $nil for the year ended December 31, 2015, was capitalized
in property, plant and equipment (2014 - $nil, 2013 - $116).
12.
Related Party Transactions and Balances
(a)
Loan from a non-controlling shareholder
Loan - current
December 31,
2015
December 31,
2014
$
2,470 $
2,595
F-29
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The Company has a loan due to Dalian Jin Gang Group, the non-controlling shareholder of Sinovac Dalian, which is unsecured, bearing interest
at 7.2% per year. Interest expense was $183 in 2015 (2014 - $221, 2013 - $237). Interest is payable monthly. As of December 31, 2015, $nil of
interest payable is included in loan from a non-controlling shareholder (December 31, 2014 - $16). $199, $649 (RMB 4 million) and $237K
were repaid for the years ended December 31, 2015, 2014 and 2013, respectively.
(b)
The Company entered into the following transactions in the normal course of operations at the exchange amount with related parties:
Rent expenses payable to SinoBioway Biotech Group Co. Ltd.
(“SinoBioway”).
$
852 $
869 $
847
2015
For the year ended December 31,
2013
2014
In 2004, the Company entered into two operating lease agreements with SinoBioway, the non-controlling shareholder of Sinovac Beijing, with respect
to Sinovac Beijing’s production plant and laboratory in Beijing, China with annual lease payments totaling $220 (RMB 1.4 million). The leases
commenced on August 12, 2004 and have a term of 20 years. One of the lease agreements was amended on August 12, 2010 with the rent increasing
from $81 (RMB 0.5 million) to $220 (RMB 1.4 million) per year.
In June 2007, the Company entered into another operating lease agreement with SinoBioway, with respect to the expansion of Sinovac Beijing’s
production plant in Beijing, China for an annual lease payment of $325 (RMB 2.0 million). The lease commenced in June 2007 and has a term of 20
years.
In September 2010, the Company entered into another operating lease agreement with SinoBioway with respect to expansion of Sinovac R&D’s
business in research and development activities for an annual lease payment of $161 (RMB 1.0 million). The lease commenced on September 30, 2010
and has a term of five years.
On April 8, 2013, the Company entered into three supplemental agreements with SinoBioway, under which the expiration date of three of the four
operating lease agreements was extended to April 7, 2033.
Included in current and long-term prepaid expenses and deposits as at December 31, 2015, is $377 (RMB 2.4 million) (December 31, 2014-$389 (RMB
2.4 million)), representing prepaid lease payments made to SinoBioway.
F-30
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
13.
Accounts Payable and Accrued Liabilities
Trade payables
Machinery and equipment payables
Accrued expenses
Value added tax payable
Other tax payable
Withholding tax payable
Bonus and benefit payables
Other payables
Total
14.
Income Taxes
Antigua and Barbuda
December 31, 2015 December 31, 2014
3,033
$
2,050
8,330
200
171
338
5,626
2,790
22,538
1,715 $
2,220
9,647
260
183
238
5,231
3,030
22,524 $
$
Under the current laws of Antigua and Barbuda, the Company is not subject to tax on income or capital gains. Additionally, upon payments of
dividends by the Company to its shareholders, no Antigua and Barbuda withholding tax will be imposed.
Hong Kong
Under the Hong Kong tax laws, Sinovac Hong Kong is exempted from income tax on its foreign-derived income and there are no withholding taxes in
Hong Kong on remittance of dividends.
China
Effective from January 1, 2008, the PRC’s statutory income tax rate is 25%. The Company’s PRC subsidiaries are subject to income tax at the statutory
rate of 25% except for Sinovac Beijing. Sinovac Beijing, being reconfirmed as a “High and New Technology Enterprise” (“HNTE”) in 2014 for a
period of 3 years, is subject to a preferential income tax rate of 15% from 2014 to 2016.
The Company’s income before income tax from continuing operations consists of:
Non-PRC
PRC
Total
For the year ended December 31,
2015
2014
$
$
(2,802) $
5,833
3,031
$
(1,336) $
3,982
2,646
$
2013
(65)
9,476
9,411
The Company’s (loss) before income tax from discontinued operations consists of:
Non-PRC
PRC
Total
2015
$
-
(728)
(728) $
For the year ended December 31,
2013
2014
-
$
(1,524)
(1,524) $
-
(1,266)
(1,266)
$
$
Income taxes that are attributed to the discontinued operations in China were $nil for all the periods presented.
F-31
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The benefit (provision) for income taxes for the years ended December 31, 2015, 2014 and 2013 was allocated between continuing operations and
discontinued operations as follows:
Continuing operations
Discontinued operations
Total
Income taxes are attributed to the continuing operations in China and consist of:
Current
Deferred
Total income tax benefit (expense)
2015
(2,516) $
-
(2,516) $
2015
(3,034) $
518
(2,516) $
For the year ended December 31,
2013
2014
(1,458) $
-
(1,458) $
2,225
-
2,225
For the year ended December 31,
2013
2014
(1,620) $
162
(1,458) $
-
2,225
2,225
$
$
$
$
The following is a reconciliation of the Company’s total income tax benefit (expense) to the amount computed by applying the PRC statutory income
tax rate of 25% to its income from continuing operations before income taxes for the years ended December 31, 2015, 2014 and 2013:
Income from continuing operations before income taxes
Income tax expense at the PRC statutory rate
International tax rate differential
Super deduction for research and development expenses
Non-deductible expenses
Other adjustments
Effect of preferential tax rate
Change in valuation allowance
Effect of PRC withholding tax
Effect of prior years’ income tax arising from tax inspection
Income tax benefit (expense)
$
$
$
2015
3,031
(758)
(701)
463
(900)
139
1,350
(1,618)
(89)
(402)
(2,516) $
F-32
$
For the year ended December 31,
2013
9,411
(2,352)
(16)
332
(159)
297
1,573
2,550
-
-
2,225
2014
2,646
(662)
(334)
605
(524)
(89)
901
(1,249)
(106)
-
(1,458) $
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The tax effects of temporary differences from continuing operations that give rise to the Company’s deferred tax assets are as follows:
Accrued expenses
Inventories
Prepaid expenses and deposits
Deferred government grants
Less: valuation allowance
Deferred tax assets, current portion
Fixed assets
Deferred government grants
Tax losses carried forward
Less: valuation allowance
Deferred tax assets, non-current portion
$
$
$
$
December 31,
2015
2,551
266
-
203
(417)
2,603
$
1,664
259
9,867
(11,197)
593
$
2014
2,410
72
(6)
12
(222)
2,266
1,105
428
8,665
(9,683)
515
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets
will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in
which the temporary differences become deductible or utilized. The Company considers projected future taxable income and tax planning strategies in
making this assessment. Based upon an assessment of the level of historical taxable income and projections for future taxable income over the periods
in which the deferred tax assets are deductible or can be utilized, the Company provided valuation allowance of $11,614 as of December 31, 2015
( December 31, 2014 - $9,905).
The Company evaluates its valuation allowance requirements at end of each reporting period by reviewing all available evidence, both positive and
negative, and considering whether, based on the weight of that evidence, a valuation allowance is needed. When circumstances cause a change in
management’s judgement about the realizability of deferred tax assets, the impact of the change on the valuation allowance is generally reflected in
income from operations. The future realization of the tax benefit of an existing deductible temporary difference ultimately depends on the existence of
sufficient taxable income of the appropriate character within the carryforward period available under applicable tax law.
Tax losses of the Company’s PRC subsidiaries in the amount of $39,466 (RMB 238 million) as of December 31, 2015 will expire from 2016 to 2020.
As of December 31, 2015, the Company has not recognized any deferred tax liability on Sinovac Beijing’s undistributed earnings of approximately
$10,733, in view of the Company's permanent reinvestment plan. The Company would be subject to PRC withholding income taxes at 5% or 10%,
depending on the availability of treaty benefit between China and Hong Kong, upon the distribution of such profits outside of China. As of December
31, 2015, the amount of unrecognized deferred tax liability ranges from $537 to $1,073.
The changes in unrecognized tax benefits are as follows:
Balance at January 1
Additions for tax positions of the current year
Additions for tax positions of the prior years
Settlement with the taxing authority
Lapse of statute of limitations
Balance at December 31
2015
454
159
281
(103)
(35)
756 $
For the year ended December 31,
2013
335
15
-
-
-
350
2014
350
160
-
-
(56)
454 $
$
F-33
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The Company recognizes interest and penalties, if any, related to unrecognized tax benefits as part of its income tax expenses. The Company did not
record any interest and penalties for the periods presented. The PRC tax law provides statute of limitations ranging from 3 to 5 years and for transfer
pricing related matters, it could be extended to 10 years. The PRC tax returns for the Company’s PRC subsidiaries are open to examination by tax
authorities for the tax years beginning in 2005.
As of December 31, 2015, the Company had unrecognized tax benefits of approximately $756 (December 31, 2014 - $454, December 31, 2013 - $350)
and such balance was included in “other non-current liabilities”. As of December 31, 2015, unrecognized tax benefits amounting to $607 would affect
the effective tax rate if recognized (December 31, 2014 - $454, December 31, 2013 - $350). In February 2015, a local taxing authority initiated a tax
audit on one of the Company’s PRC subsidiaries for the year ended December 31, 2013. The local taxing authority completed the audit in September
2015 and disallowed the deductibility of certain expenses of the concerned subsidiary. The Company paid $397 income tax expenses as a result of the
tax audit. The potential tax exposures of the related open tax years for similar expenses were $281, which was recorded as unrecognized tax benefits as
of December 31, 2015. The Company does not expect the amount of unrecognized tax benefits would change significantly in the next 12 months.
15.
Deferred Revenue
Current deferred revenue included $6,549 received from the Chinese government for stockpiling of H5N1 vaccines (December 31, 2014 - $3,546) that
expire within one year and $1,595 of advances from customers (December 31, 2014 - $1,450).
No long-term deferred revenue was received from the Chinese government for stockpiling of H5N1 vaccines as of December 31, 2015 (December 31,
2014 -$7,191).
16.
Deferred Government Grants
Deferred government grants represent funding received from the government for research and development (“R&D”), or investment in building or
improving production facility. The amount of deferred government grants as at year end is net of research and development expenditures or
depreciation incurred or those recognized as government grant income. The Company received $236 (RMB 1.5 million) of government grant in 2015
(2014 - $3,496 (RMB 21.6 million), 2013 - $842 (RMB 5.2 million)). In addition, the Company received $308 (RMB 1.9 million), $24 (RMB 0.1
million ) and $nil interest subsidy, rental fee subsidy and other government grants recognized in the statements of comprehensive income (loss) in
2015, 2014 and 2013, respectively.
F-34
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Summarized below are deferred government grants as of December 31, 2015 and 2014:
Construction of a pandemic influenza vaccine plant and buildings (a)
Purchasing equipment for H1N1 vaccine production (b)
Purchasing equipment for H5N1 vaccine production (c)
EV71 vaccine production facility (d)
Research and development for EV71 (e)
Loan from Zhongguancun Development Group (f)
Others (g)
Current deferred government grants
Construction of a pandemic influenza vaccine plant and buildings (a)
Purchasing equipment for H1N1 vaccine production (b)
Purchasing equipment for H5N1 vaccine production (c)
EV71 vaccine production facility (d)
Research and development for EV71 (e)
Loan from Zhongguancun Development Group (f)
Others (g)
Non-current deferred government grants
Total deferred government grants
December 31,
2015
278 $
137
15
259
77
358
78
1,202
848
330
46
2,828
-
-
678
4,730
5,932 $
December 31,
2014
290
143
16
-
-
-
81
530
1,176
488
64
3,223
1,524
376
643
7,494
8,024
$
$
(a) Deferred government grants included $1,126 (RMB 7.3 million) representing the unamortized portion of the amount that the Company received in
2007 for construction of a pandemic influenza vaccine plant and buildings of RMB 20 million (December 31, 2014 - $1,466 (RMB 9.1 million)). $278
(RMB 1.8 million) which will be amortized in 2016 was included in the current portion and $848 (RMB 5.5 million) which will be amortized after
2016 was included in the non-current portion of the deferred government grants. The production facility grant requires the Company to have the entire
facility available to manufacture pandemic influenza vaccines at any given moment upon request by the Chinese government. The Company has
fulfilled the conditions attached to the government grant. Government grant relating to these production facilities of $287, $290 and $237 for the years
ended December 31, 2015, 2014 and 2013 were recorded as a reduction to depreciation expense for those respective years.
(b) Deferred government grants also included $467 (RMB 3.0 million) being the unamortized portion of the amount that the Company received in 2009
for purchasing equipment for H1N1 vaccine production with a total amount of $999 (RMB 6.2 million). The amount of $137 (RMB 0.8 million) which
will be recognized in 2016 was included in the current portion and the amount of $330 (RMB 2.2 million) which will be recognized after 2016 was
included in the non-current portion of deferred government grants. The Company has fulfilled the conditions attached to the government grant.
Government grant relating to this production facility of $141, $143 and $119 for the years ended December 31, 2015, 2014 and 2013 were recorded as
a reduction to the related depreciation expense.
(c) Deferred government grants also included $61 (RMB 0.4 million) being the unamortized portion of the amount that the Company received in 2013
for purchasing equipment for H5N1 vaccine production. The Company has fulfilled the conditions attached to the government grant. The amount of
$15 (RMB 0.1 million) which will be amortized in 2016 was included in the current portion and the amount of $46 (RMB 0.3 million) which will be
amortized after 2016 was included in the non-current portion of deferred government grants. Government grant relating to this production facility of
$16, $16 and $16 for the years ended December 31, 2015, 2014 and 2013, respectively, were recorded as a reduction to the related depreciation
expense.
F-35
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(d) The Company received a government grant in the amount of $3,087 (RMB 20 million) for equipment purchase and construction of the Enterovirus
71 ("EV71") vaccine production facility. As of December 31, 2015, the Company has not fulfilled the conditions attached to the government grant. The
Company obtained the Good Manufacturing Practices (“GMP”) certificate of its EV71 vaccine issued by the CFDA in January 2016, which was the
final major condition attached to the grant. The amount of $259 (RMB 1.7 million) which will be amortized in 2016 was included in the current portion
and the amount of $2,828 (RMB 18.3 million) which will be amortized after 2016 was included in the non-current portion of deferred government
grants.
(e) Deferred government grants also included $77 (RMB 0.5 million) that the Company received in 2015 for EV71 research and development. As the
Company has obtained the GMP certificate of its EV71 vaccine issued by the CFDA in January 2016 and is expected to fulfill the conditions within
one year, the grant is recorded as a current deferred government grant. As of December 31, 2015, the Company has obtained the new drug certificate
and production license of EV71 vaccine issued by the CFDA, and has fulfilled the conditions attached to three government grants received in prior
years for EV71 research and development with a total amount of $1,598 (RMB 10 million). These grants were recognized as government grant
recognized in income for the year ended December 31, 2015.
(f) The Company received a loan of $1,934 (RMB 12 million) bearing an interest rate of 0.36% per year from Beijing Zhongguancun Development
Group. The fair value differential (between the face value and the fair value using the effective interest rate method at the Company's borrowing rate of
6.9%) is recorded as current deferred government grant of $358 (December 31, 2014 - $376) (see note 11), since the loan will mature in 2016. The
Company has repaid the loan in full in February 2016.
(g) Deferred government grants also included $756 (RMB 4.9 million) in relation to four other research projects. As of December 31, 2015, the
conditions attached to three of the four government grants totalling $678 (RMB 4.4 million) have not been fulfilled by the Company. As the Company
does not expect to fulfill the conditions within one year, these grants are recorded as non-current deferred government grants (December 31, 2014 -
$642 (RMB 4 million)). The Company expects to fulfil the conditions attached to one of the four grants and recorded $78 (RMB 0.5 million) as a
current deferred government grant (December 31, 2014 - $81 (RMB 0.5 million)).
17.
Commitments and Contingencies
(a)
Operating Lease Commitments
The Company leases production plant and laboratory under operating leases from its related parties (note 12(b)). Rental expense amounted to $852 for
the year ended December 31, 2015 (2014 - $869, 2013 - $847).
F-36
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Minimum future rental payments under operating leases to related parties for the years ending December 31 are as follows:
2016
2017
2018
2019
2020
Thereafter
Total minimum future payments
(b)
Other Commitments
$
$
852
852
852
852
852
8,601
12,861
In addition to commitments disclosed in note 24, commitments related to R&D expenditures are $441 as at December 31, 2015.
Commitments related to capital expenditures for the Company’s Sabin Inactivated Polio vaccine, pneumococcal polysaccharide vaccine and varicella
vaccine production facilities are approximately $1,726 as at December 31, 2015.
18.
Common Stock
Share Capital
Each share of common stock is entitled to one vote per share and is entitled to dividends when declared by the Company’s board of directors. As of
December 31, 2015 and 2014, there were 56,906,561 and 55,809,661 shares of common stock outstanding, respectively. As of December 31, 2015 and
2014, there was no preferred stock issued and outstanding.
In 2013, the Company issued 360,600 shares of common stock on the exercise of employee stock options with exercise price of $1.60 per share and
118,200 shares of common stock on the exercise of employee stock options with exercise price of $2.37 per share, for total proceeds of $848. The
Company received further cash proceeds of $18 on the exercise of stock option for which the shares were issued subsequent to December 31, 2013.
In 2014, the Company issued 48,000 shares of common stock on the exercise of employee stock options with exercise price of $1.60 per share and
191,300 shares of common stock on the exercise of employee stock options with exercise price of $2.37 per share, for total proceeds of $512. The
Company received further cash proceeds of $51 on the exercise of stock option for which the shares were issued subsequent to December 31, 2014.
In 2015, the Company issued 115,500 shares of common stock on the exercise of employee stock options with exercise price of $1.60 per share and
252,400 shares of common stock on the exercise of employee stock options with exercise price of $2.37 per share, for total proceeds of $732. The
Company received further cash proceeds of $18 on the exercise of stock option for which the shares were issued subsequent to December 31, 2015.
In May 2015, the Company granted 729,000 restricted shares at par value of $0.001 for total proceeds of $1 to directors, officers and employees of the
Company.
F-37
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
19.
Stock Options
(a)
Stock Option Plan
The board of directors approved a stock option plan (the “2003 Plan”) effective on November 1, 2003, pursuant to which directors, officers, employees
and consultants of the Company are eligible to receive grants of options for the Company’s common stock. The 2003 Plan expires on November 1,
2023. Up to 10% of the Company’s then outstanding common stocks were reserved for issuance under the 2003 Plan. As of December 31, 2015,
42,800 shares of common stock under the 2003 Plan remain available for issuance. Each stock option entitles its holder to purchase one share of
common stock of the Company. Options may be granted for a term not exceeding 10 years from the date of grant. The 2003 Plan is administered by the
board of directors.
In December 2011, the Company granted 767,000 options to employees with an exercise price of $2.37, being the quoted market price of the
Company’s shares at the time of grant. 10% of the options vest every three months from December 26, 2012 to March 26, 2015 and expire on
December 25, 2017. This grant was fully vested on March 26, 2015.
On May 1, 2012, the Company granted 50,000 options to an officer with an exercise price of $2.05, being the quoted market price of the Company’s
shares at the time of grant. The options were granted on May 1, 2012 and expire on April 30, 2017. 10% of the options will vest on May 1, 2013 (the
“Initial Vesting Date”) and the remaining options will vest at 10% in equal quarterly proportions over a period of 27 months from the Initial Vesting
Date. The officer has left the Company at the end of May 2013 and forfeited the unvested options in June 2013.
On August 22, 2012, the board of directors approved a new stock option plan (the “2012 Plan”), which allowed the Company to issue up to 4,000,000
options for common shares and restricted shares of the Company to directors, officers, employees and consultants of the Company. Each stock option
entitles its holder to purchase one share of common stock of the Company. Options and restricted shares may be granted for a term not exceeding 10
years from the date of grant. The 2012 Plan is administered by the board of directors. The 2012 Plan will expire on August 22, 2022. Any awards that
are outstanding on August 22, 2022 will remain in force according to the terms of the 2012 Plan and the applicable award agreement.
On May 1, 2015, the Company granted 729,000 restricted shares at par value of $0.001 and 1,341,000 options under the 2012 Plan with an exercise
price of $4.98, being the quoted market price of the Company’s shares at the time of grant. The options will expire on April 30, 2023. One-fifth (1/5) of
the restricted shares and options shall vest on the first, second, third, fourth and fifth anniversaries of date of grant, respectively. The restricted shares
are not subject to any restriction on transfer and repurchase after they are vested.
F-38
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(b)
Valuation Assumptions
The following assumptions were used in determining the fair value of stock options under the Black-Scholes option-pricing model for grants under the
2012 Plan:
Expected volatility
Risk-free interest rate
Expected life (years)
Dividend yield
Estimated forfeiture rate
2015
2014
2013
51.42%
1.5%
5.5
0%
7%
-
-
-
-
-
-
-
-
-
-
The weighted average fair value of options granted for the year ended December 31, 2015 was $2.37 per option (2014 - $nil, 2013 - $nil).
Expected volatility is estimated based on the Company’s historical stock prices. Computation of expected life was estimated using simplified method
for “plain-vanilla” options as the Company considers the options granted to have “plain-vanilla” characteristics. The risk-free interest rates for the
period within the contractual life of the awards are based on the U.S. Treasury yield in effect at the time of grant. Estimated forfeiture rates are
determined based on expected future employee behaviour.
The fair value of restricted shares is based on the fair market value of the underlying common stock on the date of the grant.
F-39
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(c)
Stock-based Payment Award Activity
A summary of the Company’s stock options activity for the 2003 and 2012 Plan is presented below:
Number
of Options
Weighted
Average
Exercise Price
($/option)
Outstanding as at January 1, 2015
Granted
Exercised
Forfeited / Expired
Outstanding as at December 31, 2015
Vested and expected to vest at December 31, 2015
Exercisable as at December 31, 2015
$
637,200
1,341,000
(367,900)
(129,900)
1,480,400 $
1,386,530
$
139,400 $
A summary of the Company’s non-vested restricted share activity for the 2012 plan is presented below:
Non-vested as at January 1, 2015
Granted
Vested
Forfeited / Expired
Non-vested as at December 31, 2015
As at December 31,2015
Aggregate Intrinsic
Value
($)
1,997,644
-
-
-
1,459,330
$
2.09
4.98
2.13
1.71
4.73 $
4.72
$
2.37 $
1,389,866
466,990
Number
of Non-Vested
Restricted
shares
Weighted Average
Grant Date
Fair Value ($)
$
—
729,000
—
—
729,000 $
—
4.98
—
—
4.98
Exercise
Prices
($/option)
Number of
Options
Outstanding
Remaining Average
Contractual
Life (years)
Average
Exercise
Price
($/option)
Number
of
Options
Exercisable
Remaining
Contractual
Life (years)
Average Exercise
Price
($/option)
$
$
2.37
4.98
139,400
1,341,000
1,480,400
1.99
$
7.33 $
6.83
2.37
4.98
139,400
-
139,400
1.99
1.99
$
-
$
2.37
-
2.37
Stock-based compensation expense, included in cost of sales, selling, general and administrative expenses, and R&D expenses is charged to operations
over the vesting period of the options using the straight-line amortization method. The share-based compensation expense was $952 in 2015 (2014 -
$287, 2013 - $281). As of December 31, 2015, there was $2,557and $2,921 of unrecognized compensation cost related to non-vested stock options and
non-vested restricted shares, respectively, granted under the 2012 Plan, which will be recognized over a weighted average period of 52 months,
respectively.
F-40
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The aggregate intrinsic value of the Company’s stock options is calculated as the difference between the exercise price of the options and the quoted
price of the common shares that were in the money. The aggregate intrinsic value of the Company’s stock options exercised under the 2003 Plan was
$1,118 for year ended December 31, 2015, determined as of the date of option exercise (2014 - $840, 2013 - $1,344).
The estimated fair value of stock options vested during the year ended December 31, 2015 was $104 (2014 - $414, 2013 - $420).
20.
Statutory surplus reserves
Pursuant to Chinese company law applicable to foreign investment companies, the Company’s PRC subsidiaries are required to maintain statutory
surplus reserves. The statutory surplus reserves are to be appropriated from net income after taxes, and should be at least 10% of the after tax net
income determined in accordance with accounting principles and relevant financial regulations applicable to PRC enterprises (“PRC GAAP”). The
Company has an option of not appropriating the statutory surplus reserve after the statutory surplus reserve is equal to 50% of the subsidiary’s
registered capital. Statutory surplus reserves are recorded as a component of shareholders’ equity. The statutory surplus reserve as at December 31,
2015 is $13,450 (2014 - $12,627).
For the year ended December 31, 2015, Sinovac Beijing appropriated 10% (2014 - 10%, 2013 - 0%) of its after-tax profit, determined under PRC
GAAP, to the statutory surplus reserves. For the year ended December 31, 2015, statutory surplus reserves appropriated are $823 (RMB 5.2 million)
(2014 - $819, 2013 - $nil).
Pursuant to the same Chinese company law, the Company’s subsidiaries, Sinovac Beijing, Tangshan Yian, Sinovac R&D, Sinovac Dalian and Sinovac
Biomed can transfer, at the discretion of their respective boards of directors, a certain amount of their annual net income after taxes as determined
under PRC GAAP to a staff welfare and bonus fund which shall be utilized for collective staff benefits. For the year ended December 31, 2015, the
amount is $nil for contribution to such fund (2014 - $nil, 2013 - $nil). The amounts appropriated to the staff welfare and bonus fund were charged
against income and the related provisions were reflected as accrued liabilities in the consolidated balance sheets.
Tangshan Yian recorded a net loss for each of the three years in the period ended December 31, 2015, so no appropriation to the statutory surplus
reserves and staff welfare and bonus fund was made.
Sinovac R&D, Sinovac Dalian and Sionvac Biomed have not made any profit since inception. No appropriation to the statutory surplus reserves and
staff welfare and bonus were made.
Dividends declared by the Company’s PRC subsidiaries are based on the distributable profits as reported in their statutory financial statements reported
in accordance with PRC GAAP, which differ from the results of operations reflected in the consolidated financial statements prepared in accordance
with US GAAP. The Company’s ability to pay dividends is primarily dependent on the Company receiving distributions of funds from its PRC
subsidiaries. Dividends declared in 2015 was $nil to the non-controlling shareholder of Sinovac Beijing (2014 - $nil, 2013 - $nil). As of December 31,
2015, the Company has $nil dividend payable (December 31, 2014 - $nil).
F-41
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Under PRC laws and regulations, statutory surplus reserves are restricted to set-off against losses, expansion of production and operation and
increasing registered capital of the respective company, and are not distributable other than upon liquidation. Staff welfare and bonus funds are
restricted to expenditures for the collective welfare of employees. The reserves are not allowed to be transferred to the Company in terms of cash
dividends, loans or advances, nor are they allowed for distribution except under liquidation. Amounts restricted include the PRC subsidiaries’ paid-in
capital and statutory surplus reserves of the Company’s PRC subsidiaries totalling $77,511 (RMB 502 million) as of December 31, 2015 (December
31, 2014, $80,091 (RMB 497 million)). Further, foreign exchange and other regulations in the PRC further restrict the Company’s PRC subsidiaries
from transferring funds to the Company in the form of loans, advances or cash dividends. As of December 31, 2015, amounts restricted include the net
assets of the Company’s PRC subsidiaries, which amounted to $66,590 (December 31, 2014 - $61,345).
21.
Non-controlling Interests
Non-controlling interests represent the interest of non-controlling shareholders in Sinovac Beijing and Sinovac Dalian based on their proportionate
interests in the equity of that company adjusted for its proportionate share of income or losses from operations. On October 1, 2011, the Company
increased its ownership in Sinovac Beijing by an additional 1.53% by contributing the dividends declared to Sinovac Hong Kong but unpaid in the
amount of $2,998 (RMB 18.6 million). An adjustment of $258 (RMB 1.6 million) resulted from the difference between the adjustment to the carrying
amount of the non-controlling interest in Sinovac Beijing and the consideration that was charged to additional paid-in capital. The non-controlling
interest in Sinovac Beijing was 28.44% prior to October 1, 2011 and was 26.91% after October 1, 2011. On April 8, 2013, SinoBioway transferred its
26.91% equity interests in Sinovac Beijing to SinoBioway Bio-medicine Co., Ltd, (formerly named Xiamen Bioway Biotech Co., Ltd.), a company
owned by SinoBioway. There was no change to the composition of the board of directors of Sinovac Beijing after the completion of the transaction.
The non-controlling interest in Sinovac Dalian was 45% as of December 31, 2015 and December 31, 2014.
F-42
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
22.
Earnings (loss) per Share
The following table sets forth the computation of basic and diluted income (loss) attributable to shareholders of Sinovac per share::
For the year ended December 31
Numerator
Income (loss) from continuing operations
Less: Income (loss) attributable to non-controlling interests
Income (loss) attributable to shareholders of Sinovac from continuing operations
Income (loss) attributable to shareholders of Sinovac from discontinued operations
Net income (loss) attributable to shareholders of Sinovac
2015
2014
2013
515
861
(346)
(728)
(1,074)
1,188
515
673
(1,524)
(851)
11,636
2,928
8,708
(1,266)
7,442
Denominator
Basic weighted average number of common shares outstanding
Dilutive effect of stock options
Diluted weighted average number of common shares outstanding
Basic net income (loss) per share
Continuing operations
Discontinued operations
Basic net income (loss) per share
Diluted net income (loss) per share
Continuing operations
Discontinued operations
Diluted net income (loss) per share
56,313,927
-
56,313,927
55,681,076
433,126
56,114,202
55,301,276
501,062
55,802,338
(0.01)
(0.01)
(0.02)
(0.01)
(0.01)
(0.02)
0.01
(0.03)
(0.02)
0.01
(0.03)
(0.02)
0.15
(0.02)
0.13
0.15
(0.02)
0.13
Anti-dilutive options were not included in the diluted EPS calculation for the year ended December 31, 2015.
Anti-dilutive non-vested restricted shares were not included in the diluted EPS calculation for the year ended December 31, 2015.
23.
Segment Information
The Company operates exclusively in the biotechnology sector. The Company’s business is considered as operating in one segment. The Company’s
Chief Executive Officer is the chief operating decision maker and reviews the consolidated results of operations when making decisions about
resources allocation and assessing performance of the Company as a whole. All revenues are generated from the subsidiaries located in China. Total
long-lived assets of $73,514 including prepaid land lease payments, property, plant and equipment and licenses are all located in mainland China
(December 31, 2014 - $76,846). The Company’s total assets by geographic location are as follows:
Assets
Mainland China
Hong Kong
Total
December 31, 2015 December 31, 2014
$
$
173,629 $
29,355
202,984 $
207,645
30,885
238,530
F-43
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
The Company’s revenues by product are as follows:
Sales
Inactivated hepatitis vaccines
Influenza vaccines
H5N1
Mumps
Total
2015
$
49,416
12,674
3,852
1,472
67,414 $
For the year ended December 31,
2013
2014
48,450 $
12,131
201
2,150
62,932 $
47,202
12,156
10,736
1,680
71,774
$
$
For the year ended December 31, 2015, one of the Company’s customer accounted for 14% of the Company’s total vaccines revenue, at $9,128. The
H5N1 vaccines were all sold to the Chinese government. The Company’s sales of H5N1 vaccines are dependent on government stockpiling purchases.
The Company’s revenues are attributed to geographic locations as follows:
Sales
Mainland China
Foreign countries
Total
2015
66,779
$
635
67,414 $
For the year ended December 31,
2013
2014
61,955 $
977
62,932 $
70,647
1,127
71,774
$
$
F-44
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
24.
Collaboration Agreements
(a)
On March 12, 2009, the Company entered into a technology transfer agreement (with an amendment agreement entered on December 14,
2011) with Tianjin CanSino Biotechnology Inc. (“Tianjin Cansino”). According to the agreement, Tianjing Cansino will transfer the
technology related to pneumococcal vaccine to the Company and jointly develop the technology with the Company. The collaboration term
under the technology transfer agreement is from March 12, 2009 to eight years after the first sale of the vaccine developed under the
technology transfer agreement in the Chinese market.
Under the terms of the technology transfer agreement, the Company will make milestone payments of up to $3,000 and royalty payments
ranging from 6% to 10% of net sales in China. Both parties will work together to develop international markets for the products. On
November 17, 2009 and December 14, 2011, two amendment agreements were signed for the payment of $300 for the transfer of an
additional six serotypes and related technology. As of December 31, 2015, the Company made total milestone payments of $1,200 ($1,000
under the March 12, 2009 agreement and $200 under the December 14, 2011 amendment). The remaining milestone payments will be paid
when the Company achieves each specific milestone, which includes obtaining clinical trials approval, completing clinical trials and
achievement of desired results, and achievement of commercial sales.
On January 29, 2015, the Company entered into a third amendment to the technology transfer agreement dated March 12, 2009 and the two
amendment agreements dated November 17, 2009 and December 24, 2011. By entering into this third amendment, the technology transfer
agreement was revised to be a licensing agreement. The remaining milestone and royalty payments under the technology transfer agreement
have been reduced. Both the Company and Tianjin Cansino are free to develop pneumococcal vaccines or to collaborate with one other
company for the same purpose. The Company made a payment of $300 and recorded it in R&D expenses in March 2015 (2014 - $nil, 2013 -
$nil).
(b)
On August 18, 2009, the Company entered into a patent license agreement with the National Institutes of Health (“NIH”), an agency of the
United States Public Health Services within the Department of Health and Human Services. NIH has granted the Company a non-exclusive
license to make and use certain of its products. NIH has also granted the Company the right to use certain associated information for
development of its licensed products. The collaboration term under the patent license agreement is from August 18, 2009 to the later of (a) the
expiration of all royalty obligations under the licensed rights where such rights exist and (b) eight years after the first commercial sale by the
Company, unless the agreement is terminated earlier per the provisions included therein.
F-45
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(c)
(d)
The Company has agreed to pay NIH a license issue royalty of $80 upon execution of the agreement and a non-refundable minimum annual
royalty of $8, and royalty payments on net sales ranging from 1.5% to 4% depending on the sales territory and the customers. The Company
has also agreed to pay NIH benchmark royalties of $330 upon achieving each benchmark as specified in the patent license agreement,
including completion of clinical trials, obtaining regulatory approval for marketing, and achievement of commercial sales. The Company
recorded a license issue royalty of $9 for the year ended December 31, 2015 as R&D expenses (2014 - $8, 2013 - $21).
On August 15, 2011, the Company licensed from Medimmune, LLC, a US based pharmaceutical company, certain non-exclusive rights to use
patented reverse genetics technology pertaining to H5N1 influenza virus strain production for vaccines. The Company has agreed to pay an
upfront license fee and milestone payments of up to an aggregate of $9.9 million based upon achievement of cumulative net sales of licensed
products in China (including Hong Kong and Macau), as well as royalty payments in single digit of net sales of the licensed products in China
(including Hong Kong and Macau). License fee and royalties of $3,400 accrued at the end of 2011 were paid in 2012. In 2013, the Company
obtained a new stockpile order of 3 million doses of H5N1 vaccines from the Chinese government. For the year ended December 31, 2013,
royalties of $1,036 was capitalized as inventory costs and included in accounts payable and accrued liabilities, which was paid in May 2014.
No royalties were incurred for the years ended December 31, 2015 and 2014, respectively.
On August 15, 2012, the Company entered into amendment agreements with Medimmune to revise the termination date of the license to
December 29, 2015 as a result of amendment of the main license agreement to end on December 29, 2015.
On April 3, 2014, the Company entered into a non-exclusive license agreement (the “Agreement”) with The Institute for Translational
Vaccinology (“INTRAVACC”), a governmental institute working under the Dutch Ministry of Public Health, Welfare and Sports, to develop
and commercialize the Sabin Inactivated Polio Vaccine (“sIPV”) for distribution in China and other countries. The Company expects to
develop and commercialize the vaccine in China, as well as seeking regulatory approval in other countries. The agreement has a term of 50
years.
The Company has agreed to pay INTRAVACC up to $2,406 (€1.5 million), net of PRC tax, including an entrance fee and milestone payments
upon achieving specific milestones. The Company has also agreed to pay royalty payments in a single digit percentage of net sales generated
worldwide from the product or products developed under the Agreement. The Company recorded an entrance fee of $665 (€0.5 million) for the
year ended December 31, 2014 as research and development expense. The Company also recorded $125 (€94) for payment made to
INTRAVACC for use of sIPV viral seeds in R&D expenses for the year ended December 31, 2014. There was no expense incurred or paid to
INTRAVACC for the year ended December 31, 2015.
F-46
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
(e)
In September 2015, Sinovac Dalian entered into a technology transfer and supply agreement with GlaxoSmithKline Biologicals SA, or GSK,
to use GSK’s measles seeds to develop combination vaccines containing measles for the China market. Under this agreement, GSK agreed to
transfer its measles seeds, provide reasonable assistance and relevant technical materials to Sinovac Dalian for the purpose of developing and
producing combination vaccines containing measles.
25.
Subsequent Events
In February 2016, the Company completed the disposal of Tangshan Yian.
In March 2016, the Company adopted a shareholder rights plan (the “Rights Plan”). Pursuant to the Rights Plan, subject to limited exceptions,
upon (i) a person or group obtaining ownership of 15% or more of the Company’s common shares or (ii) the commencement or announcement
of an intention to make a tender offer or exchange offer, the consummation of which would result in the beneficial ownership by a person or
group of 15% or more of the Company’s common shares, in each case, without the approval of the Company’s board of directors, each Right
will entitle the holders, other than the acquiring person, to buy, at an exercise price of $30.00, one one-thousandth of a share of the newly
created series A junior participating preferred shares of the Company, or the Series A Preferred Shares. Holders are entitled to receive, in lieu
of each one one-thousandths of a Series A Preferred Share, common shares having a market value at that time of twice the Right’s exercise
price. The Company’s board of directors is entitled to redeem the Rights at $0.001 per Right at any time before the Rights are exercisable. The
Company refers to the person who acquired 15% or more of the outstanding common shares of the Company as the “acquiring person.”
26.
Condensed Financial Information of the Parent Company
Balance Sheets
ASSETS
Current assets
Cash and cash equivalents
Prepaid expenses and other receivables
Amount due from subsidiaries
Dividend receivables
Total current assets
Investment in subsidiaries
Total assets
LIABILITIES AND EQUITY
Current liabilities
Accrued expenses and other payables
Amount due to subsidiaries
Total current liabilities
Total liabilities
EQUITY
Preferred stock
Authorized 50,000,000 shares at par value of $0.001 each
Issued and outstanding: nil
Common stock
Authorized: 100,000,000 shares at par value of $0.001 each
Issued and outstanding: 56,906,561 (2014 – 55,809,661)
Additional paid-in capital
Accumulated other comprehensive income
Retained earnings
Total stockholders' equity
December 31,
2015
December 31,
2014
$
$
$
$
$
$
$
331
70
66,032
21,280
87,713
41,711
129,424
666
5,478
6,144
6,144
$
-
57
997
9
69,824
21,280
92,110
38,616
130,726
584
3,578
4,162
4,162
-
56
109,944
8,110
5,169
123,280
108,243
12,022
6,243
126,564
Total liabilities and equity
$
129,424
$
130,726
F-47
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Statements of Comprehensive Income (Loss)
For the year ended December 31
2014
2015
2013
Selling, general and administrative expenses
Total operating expenses
Loss from operations
Other expense
Interest income
Equity earnings of subsidiaries, net of tax
Net income (loss)
Other comprehensive income (loss), net of tax of nil
Foreign currency translation adjustments
2,563
2,563
(2,563)
(5,053)
413
6,129
(1,074)
-
(3,912)
2,466
2,466
(2,466)
-
759
856
(851)
-
(2,119)
Total comprehensive income (loss)
$
(4,986) $
(2,970) $
F-48
2,710
2,710
(2,710)
-
755
9,397
7,442
-
2,370
9,812
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Statements of Cash Flows
Cash flows provided by (used in) operating activities
Net income (loss)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating
activities:
-stock-based compensation
-equity in (earnings) of subsidiaries
Changes in:
- Amount due from subsidiaries
- Prepaid expenses and other receivables
- Dividend receivables
- Amount due to subsidiaries
- Accrued expenses and other payables
Net cash provided by (used in) operating activities
Cash flows provided by financing activities
- Proceeds from issuance of common stock, net of share issuance costs
- Proceeds from shares subscribed
Net cash provided by financing activities
Cash flows provided by (used in) investing activities
-Investment in subsidiaries
Net cash provided (used in) investing activities
Decrease in cash and cash equivalents
Cash and cash equivalents, beginning of year
For the year ended December 31
2014
2015
2013
$
(1,074) $
(851) $
7,442
952
(6,129)
3,792
(61)
-
1,900
82
(538)
732
18
750
(878)
(878)
(666)
997
287
(856)
(1,304)
114
-
1,815
(336)
(1,131)
512
51
563
165
165
(403)
1,400
281
(9,397)
2,505
59
1,043
1,130
(776)
2,287
848
18
866
(4,042)
(4,042)
(889)
2,289
1,400
Cash and cash equivalents, end of year
$
331 $
997 $
(a) Basis of presentation
The condensed financial information has been prepared using the same accounting policies as set out in the accompanying consolidated financial statements
except that the Company used the equity method to account for investment in its subsidiaries.
The Company records its investment in its subsidiaries under the equity method of accounting. Such investment is presented on the balance sheets as
“Investment in subsidiaries” and share of their income (loss) as “Equity earnings (losses) of subsidiaries” in the statements of comprehensive income (loss).
Each of the Company’s PRC subsidiaries has restrictions on its ability to pay dividends to the Company under PRC laws and regulations (Note 20). The
subsidiaries did not pay any dividends to the Company for the years presented.
F-49
SINOVAC BIOTECH LTD.
Notes to Consolidated Financial Statements
(Expressed in thousands of U.S. dollars, unless otherwise stated)
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or
omitted by reference to the consolidated financial statements.
(b) Commitments
The Company does not have any significant commitments or long-term obligations as of any of the periods presented, except for those disclosed in the
consolidated financial statements (notes 17 and 24).
F-50
List of Subsidiaries
1.
2.
3.
4.
5.
Sinovac Biotech (Hong Kong) Ltd., a Hong Kong company
Sinovac Biotech Co., Ltd., a PRC company
Sinovac Research and Development Co., Ltd. (formerly known as Beijing Sinovac Biological Technology Co., Ltd.), a PRC company
Sinovac (Dalian) Vaccine Technology Co., Ltd., a PRC company
Sinovac Biomed Co., Ltd. (formerly known as Sinovac Zhong Yi Bio-pharmaceutical Co., Ltd.)
Exhibit 8.1
CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.1
I, Weidong Yin, certify that:
1.
I have reviewed this annual report on Form 20-F of Sinovac Biotech Ltd. (the “Company”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
4. The Company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
Company and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by this annual
report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and
5. The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the Company’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over
financial reporting.
Date: April 25, 2016
/s/ Weidong Yin
By:
Name: Weidong Yin
Title:
Chief Executive Officer
CERTIFICATION BY THE CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.2
I, Nan Wang, certify that:
1.
I have reviewed this annual report on Form 20-F of Sinovac Biotech Ltd. (the “Company”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
4. The Company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
Company and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by this annual
report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and
5. The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions):
(c) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the Company’s ability to record, process, summarize and report financial information; and
(a) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over
financial reporting.
Date: April 25, 2016
By:
Name:
Title:
/s/ Nan Wang
Nan Wang
Chief Financial Officer
CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 13.1
In connection with the annual report of Sinovac Biotech Ltd. (the “Company”) on Form 20-F for the year ended December 31, 2015 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, Weidong Yin, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) The Report containing the financial statements fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 25, 2016
/s/ Weidong Yin
By:
Name: Weidong Yin
Title:
Chief Executive Officer
CERTIFICATION BY THE CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 13.2
In connection with the annual report of Sinovac Biotech Ltd. (the “Company”) on Form 20-F for the year ended December 31, 2015 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, Nan Wang, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) The Report containing the financial statements fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 25, 2016
/s/ Nan Wang
By:
Name: Nan Wang
Title:
Chief Financial Officer
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the following Registration Statements:
i) Registration Statement (Form S-8 No. 333-161827) pertaining to Sinovac Biotech Ltd.’s 2003 Stock Option Plan; and
ii) Registration Statement (Form S-8 No. 333-190980) pertaining to Sinovac Biotech Ltd.’s 2012 Share Incentive Plan;
of our reports dated April 25, 2016, with respect to the consolidated financial statements of Sinovac Biotech Ltd. and the effectiveness of internal control over
financial reporting of Sinovac Biotech Ltd., included in this Annual Report (Form 20-F) of Sinovac Biotech Ltd. for the year ended December 31, 2015.
Exhibit 15.1
/s/ Ernst & Young Hua Ming LLP
Beijing, The People’s Republic of China
April 25, 2016