UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2015
Commission File Number: 001-32371
SINOVAC BIOTECH LTD.
No. 39 Shangdi Xi Road
Haidian District
Beijing 100085, People’s Republic
of China
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
SINOVAC BIOTECH LTD. |
|
|
|
By: |
/s/ Weidong Yin |
|
Name: Weidong Yin |
|
Title: Chairman and Chief Executive Officer |
Date: May 14, 2015
Exhibit Index
Exhibit 99.1 – Press Release
Exhibit 99.1
Sinovac Reports Unaudited First Quarter
2015 Financial Results
- Conference call scheduled for May 15,
2015 at 8:00 a.m. ET -
BEIJING, May 14, 2015 /PRNewswire/ -- Sinovac Biotech Ltd.
(SVA), a leading provider of biopharmaceutical products in China, today announced its unaudited financial results for the first
quarter ended March 31, 2015.
First Quarter 2015 Financial Highlights
(Compared to the first quarter 2014)
| · | Quarterly sales were $9.3million, a decrease of 31.6% from $13.5 million
in the prior year period. |
| · | Gross profit was $6.8million, a decrease of 33.4% from $10.3 million
in the prior year period. |
| · | Net loss attributable to common shareholders was $2.3million or $0.04
per basic and diluted share for the first quarter of 2015, compared to net income of $4,000, or $0.00 per basic and diluted share,
for the first quarter of 2014. |
Mr. Weidong Yin, Chairman, President and CEO of Sinovac,
commented, "Our first quarter results reflect changes in the China vaccine market environment, particularly between
the public and private markets and the relative timing of purchases in these markets. We do not believe that the decline
in first quarter sales is indicative of overall demand for our products but rather reflects timing differences that will be resolved
over the course of the year. We were very pleased to announce the site inspection notification for our EV71 vaccine this week.
This marks a significant milestone in the approval process. As we continue to make progress on our vaccine pipeline, we are also
focusing on international growth opportunities. During the first quarter, we received our GMP certificate from the Turkish government
and GMP inspection from the Kazakhstan government. These two countries represent new market opportunities for Sinovac. We are focused
on strategically entering into international markets that offer high sales potential for our current vaccine portfolio, as well
as for our pipeline vaccines as they are commercialized."
EV 71 Vaccine Developments
As previously announced, the China Food and Drug Administration
(CFDA) issued a site inspection notification for the commercial production facilities of the Company's EV71 vaccine candidate.
This is a significant step forward for the Company in its efforts to bring its EV71 vaccine to market. Sinovac will submit its
application to schedule the site inspection, which will include production of three trial batches of the vaccine, and GMP inspection.
The Company expects this process to take four to six months.
After the trial batch testing is completed, the CFDA will consolidate
the results of the technical review, site inspection and trial batch testing and summarize its final opinion. The CFDA will then
issue the new drug certificate, production license, and GMP license.
Unaudited Financial Results for First Quarter 2015
(In USD'000 except percentage |
|
|
|
|
|
|
|
|
|
|
|
|
data) |
|
2015 Q1 |
|
|
% of Sales |
|
|
2014 Q1 |
|
|
% of Sales |
|
Hepatitis A – Healive |
|
|
2,922 |
|
|
|
31.5 |
% |
|
|
6,439 |
|
|
|
47.5 |
% |
Hepatitis A&B – Bilive |
|
|
5,055 |
|
|
|
54.5 |
% |
|
|
5,999 |
|
|
|
44.3 |
% |
Influenza vaccine |
|
|
586 |
|
|
|
6.3 |
% |
|
|
61 |
|
|
|
0.4 |
% |
Animal vaccine |
|
|
62 |
|
|
|
0.7 |
% |
|
|
25 |
|
|
|
0.2 |
% |
Mumps vaccine |
|
|
644 |
|
|
|
7.0 |
% |
|
|
920 |
|
|
|
6.8 |
% |
Regular sales |
|
|
9,269 |
|
|
|
100.0 |
% |
|
|
13,444 |
|
|
|
99.2 |
% |
H5N1 vaccine |
|
|
- |
|
|
|
0.0 |
% |
|
|
102 |
|
|
|
0.8 |
% |
Total sales |
|
|
9,269 |
|
|
|
100.0 |
% |
|
|
13,546 |
|
|
|
100.0 |
% |
Cost of goods sold |
|
|
2,434 |
|
|
|
26.3 |
% |
|
|
3,278 |
|
|
|
24.2 |
% |
Gross profit |
|
|
6,835 |
|
|
|
73.7 |
% |
|
|
10,268 |
|
|
|
75.8 |
% |
Quarterly sales were $9.3 million, a decrease of 31.6% from
$13.5 million in the prior year period.
Gross profit was $6.8 million, a decrease of 33.4% from $10.3
million in the prior year period. Gross profit margin was 73.7% compared to75.8% in the prior year period. The decrease in gross
profit margin was primarily driven by idle capacity charges recorded for the manufacturing facility. In the first quarter of 2014,
the Company produced more vaccine due to different production scheduling and incurred no idle capacity charges as a result.
Selling, general and administrative expenses for the first quarter
of 2015 were $6.9million, compared to $7.8 million in the same period of 2014. The reduction was primarily due to reduced selling
expenses as a result of the decrease in sales, as well as lower foreign exchange loss as compared to the first quarter of 2014.
R&D expenses for the first quarter of 2015 were $2.2million,
a $0.5 million increase over the same period in 2014. This increase was attributable to the continued advancement of Sinovac's
pipeline products, including sIPV, PPV and varicella vaccine.
Net loss attributable to common shareholders was $2.3 million
or $(0.04) per basic and diluted share for the first quarter of 2015, compared to net income of $4,000, or $0.00 per basic and
diluted share, for the first quarter of 2014.
Balance Sheet Highlights
As of March 31, 2015, cash and cash equivalents totaled $63.1
million, compared to $91.5 million as of December 31, 2014. Net cash used in operating activities was $8.2 million in the first
quarter of 2015. Net cash used in investing activities was $1.8 million, which was primarily used for payment for property, plant
and equipment for the Company's PPV and varicella vaccine production facilities. Net cash used in financing activities was $18.3
million in the first quarter of 2015, including $19.4 million for repayment of loans, slightly offset by proceeds from a bank loan
of $0.8 million. As of March 31, 2015, the Company had $30.5 million of loans due within one year. When appropriate, the Company
will seek new commercial bank loans to finance the commercialization of pipeline products, as well as for other operational purposes.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company
that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious
diseases. Sinovac's product portfolio includes vaccines against hepatitis A and B, seasonal influenza, H5N1 pandemic influenza
(avian flu), H1N1 influenza (swine flu), mumps and canine rabies. In 2009, Sinovac was the first company worldwide to receive approval
for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's vaccination campaign and stockpiling program.
The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. Sinovac has
filed a new drug application with the China Food and Drug Administration for its proprietary enterovirus 71 vaccine, having been
proven effective in preventing hand, foot and mouth disease in infants and children during its Phase III clinical trial. The Company
is currently developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides
vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring
growth opportunities in international markets. The Company has exported select vaccines to Mexico, Mongolia, Nepal, and the Philippines,
and was recently granted a license to commercialize its hepatitis A vaccine in Chile. For more information, please visit the Company's
website at www.sinovac.com .
Contact
Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279-9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com
ICR Inc.
Bill Zima
U.S: 1-646-308-1707
Email: william.zima@icrinc.com
Katherine Knight
Phone: +1 (646) 277-1276
Email: katherine.knight@icrinc.com
SINOVAC BIOTECH LTD.
Consolidated Balance sheets
As of March 31, 2015 and December 31, 2014
(Expressed
in thousands of U.S. Dollars, except for numbers of shares and per share data)
Current assets | |
March 31, 2015 | | |
December 31, 2014 | |
| |
| | |
| |
Cash and cash equivalents | |
| 63,070 | | |
| 91,518 | |
Accounts receivable – net | |
| 42,356 | | |
| 40,757 | |
Inventories | |
| 20,229 | | |
| 18,832 | |
Prepaid expenses and deposits | |
| 1,352 | | |
| 1,430 | |
Deferred tax assets | |
| 1,768 | | |
| 2,266 | |
Total current assets | |
| 128,775 | | |
| 154,803 | |
| |
| | | |
| | |
Property, plant and equipment | |
| 68,682 | | |
| 68,417 | |
Prepaid land lease payments | |
| 10,346 | | |
| 10,405 | |
Long-term inventories | |
| 2,738 | | |
| 2,648 | |
Long-term prepaid expenses | |
| - | | |
| 3 | |
Prepayments for acquisition of equipment | |
| 1,140 | | |
| 1,387 | |
Deferred tax assets | |
| 510 | | |
| 515 | |
Licenses | |
| 264 | | |
| 352 | |
Total assets | |
| 212,455 | | |
| 238,530 | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Short-term bank loans and current portion of long-term debt | |
| 30,542 | | |
| 47,375 | |
Loan from a non-controlling shareholder | |
| 2,597 | | |
| 2,595 | |
Accounts payable and accrued liabilities | |
| 18,565 | | |
| 23,237 | |
Income tax payable | |
| 801 | | |
| 1,101 | |
Deferred revenue | |
| 5,026 | | |
| 4,996 | |
Deferred government grants | |
| 904 | | |
| 530 | |
| |
| | | |
| | |
Total current liabilities | |
| 58,435 | | |
| 79,834 | |
| |
| | | |
| | |
Deferred government grants | |
| 7,012 | | |
| 7,494 | |
Long-term debt | |
| - | | |
| 1,803 | |
Deferred revenue | |
| 7,198 | | |
| 7,191 | |
Other non-current liabilities | |
| 479 | | |
| 482 | |
Total long term liabilities | |
| 14,689 | | |
| 16,970 | |
Total
liabilities | |
| 73,124 | | |
| 96,804 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
Equity | |
| | | |
| | |
Preferred stock | |
| - | | |
| - | |
Common stock | |
| 56 | | |
| 56 | |
Additional paid-in capital | |
| 108,620 | | |
| 108,243 | |
Accumulated other comprehensive income | |
| 12,081 | | |
| 12,022 | |
Statutory surplus reserves | |
| 12,627 | | |
| 12,627 | |
Accumulated deficit | |
| (8,635 | ) | |
| (6,384 | ) |
Total
shareholders' equity | |
| 124,749 | | |
| 126,564 | |
| |
| | | |
| | |
Non-controlling interests | |
| 14,582 | | |
| 15,162 | |
Total
equity | |
| 139,331 | | |
| 141,726 | |
Total
liabilities and equity | |
| 212,455 | | |
| 238,530 | |
SINOVAC BIOTECH LTD.
Consolidated Statements of Comprehensive Income (loss)
For the three months ended March 31, 2015 and 2014
(Unaudited)
(Expressed in thousands of U.S. Dollars, except for numbers of shares and per share data)
|
|
Three months ended March 31 |
|
|
|
2015 |
|
|
2014 |
|
Sales |
|
|
9,269 |
|
|
|
13,546 |
|
Cost of sales |
|
|
2,434 |
|
|
|
3,278 |
|
Gross profit |
|
|
6,835 |
|
|
|
10,268 |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
|
6,921 |
|
|
|
7,792 |
|
Provision (recovery) for doubtful accounts |
|
|
(89 |
) |
|
|
162 |
|
Research and development expenses |
|
|
2,212 |
|
|
|
1,702 |
|
Government grants recognized in income |
|
|
(6 |
) |
|
|
- |
|
Total operating expenses |
|
|
9,038 |
|
|
|
9,656 |
|
Operating income (loss) |
|
|
(2,203 |
) |
|
|
612 |
|
|
|
|
|
|
|
|
|
|
Interest and financing expenses |
|
|
(588 |
) |
|
|
(750 |
) |
Interest income |
|
|
427 |
|
|
|
780 |
|
Other income |
|
|
75 |
|
|
|
146 |
|
Income (loss) before income taxes and non-controlling interests |
|
|
(2,289 |
) |
|
|
788 |
|
Income tax expense |
|
|
(551 |
) |
|
|
(347 |
) |
|
|
|
|
|
|
|
|
|
Net Income (loss) |
|
|
(2,840 |
) |
|
|
441 |
|
Less: (Income) loss attributable to the non-controlling interests |
|
|
589 |
|
|
|
(437 |
) |
Net Income (loss) attributable to shareholders of Sinovac |
|
|
(2,251 |
) |
|
|
4 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss), net of tax of nil |
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
66 |
|
|
|
(2,084 |
) |
Total comprehensive income (loss) |
|
|
(2,774 |
) |
|
|
(1,643 |
) |
Less: comprehensive (income) loss attributable to non-controlling
interests |
|
|
582 |
|
|
|
(100 |
) |
Comprehensive loss attributable to shareholders of Sinovac |
|
|
(2,192 |
) |
|
|
(1,743 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares of common stock outstanding |
|
|
|
|
|
|
|
|
Basic |
|
|
56,213,166 |
|
|
|
55,587,029 |
|
Diluted |
|
|
56,213,166 |
|
|
|
56,110,870 |
|
|
|
|
|
|
|
|
|
|
Earning (loss) per share |
|
|
|
|
|
|
|
|
Basic |
|
|
-0.04 |
|
|
|
0.00 |
|
Diluted |
|
|
-0.04 |
|
|
|
0.00 |
|
SINOVAC BIOTECH LTD.
Consolidated Statements of Cash Flows
For the three months ended March 31, 2015 and 2014
(Unaudited)
(Expressed in thousands of U.S. Dollars)
|
|
Three months ended |
|
|
|
March 31 |
|
|
|
2015 |
|
|
2014 |
|
Cash flows used in operating activities |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(2,840 |
) |
|
$ |
441 |
|
Adjustments to reconcile net income (loss) to net cash |
|
|
|
|
|
|
|
|
Used in operating activities: |
|
|
|
|
|
|
|
|
- deferred income taxes |
|
|
534 |
|
|
|
311 |
|
- stock-based compensation |
|
|
113 |
|
|
|
72 |
|
- inventory provision |
|
|
45 |
|
|
|
221 |
|
- provision(recovery) for doubtful accounts |
|
|
(89 |
) |
|
|
162 |
|
- deferred government grant recognized in income |
|
|
(6 |
) |
|
|
- |
|
- depreciation of property, plant and equipment and amortization of licenses |
|
|
1,692 |
|
|
|
2,631 |
|
- amortization of the prepaid land lease payments |
|
|
69 |
|
|
|
67 |
|
- accretion expenses |
|
|
29 |
|
|
|
27 |
|
Changes in: |
|
|
|
|
|
|
|
|
- accounts receivable |
|
|
(1,843 |
) |
|
|
(4,981 |
) |
- inventories |
|
|
(1,542 |
) |
|
|
(2,879 |
) |
- income tax payable |
|
|
- |
|
|
|
7 |
|
- prepaid expenses and deposits |
|
|
664 |
|
|
|
(582 |
) |
- deferred revenue |
|
|
- |
|
|
|
(718 |
) |
- accounts payable and accrued liabilities |
|
|
(5,024 |
) |
|
|
(577 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(8,198 |
) |
|
|
(5,798 |
) |
Cash flows provided by (used in) financing activities |
|
|
|
|
|
|
|
|
- Proceeds from bank loans |
|
|
802 |
|
|
|
5,735 |
|
- Repayments of bank loans |
|
|
(19,403 |
) |
|
|
(2,458 |
) |
- Proceeds from issuance of common stock, |
|
|
|
|
|
|
|
|
net of share issuance costs |
|
|
264 |
|
|
|
105 |
|
- Proceeds from shares subscribed |
|
|
- |
|
|
|
49 |
|
- Government grants received |
|
|
3 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided (used in) by financing activities |
|
|
(18,334 |
) |
|
|
3,431 |
|
|
|
|
|
|
|
|
|
|
Cash flows used in investing activities |
|
|
|
|
|
|
|
|
- Acquisition of property, plant and equipment |
|
|
(1,781 |
) |
|
|
(2,204 |
) |
Net cash used in investing activities |
|
|
(1,781 |
) |
|
|
(2,204 |
) |
Exchange loss on cash and cash equivalents |
|
|
(135 |
) |
|
|
(1,019 |
) |
Decrease in cash and cash equivalents |
|
|
(28,448 |
) |
|
|
(5,590 |
) |
Cash and cash equivalents, beginning of year |
|
|
91,518 |
|
|
|
107,242 |
|
Cash and cash equivalents, end of year |
|
$ |
63,070 |
|
|
$ |
101,652 |
|
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