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Sinovac Reports Unaudited Fourth Quarter and Full Year 2013 Financial Results

2014-03-20

Sinovac Reports Unaudited Fourth Quarter and Full Year 2013 Financial Results

                          - Conference call scheduled for Thursday, March 20, 2014 at 8:00 AM EDT -

BEIJING, March 19, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today its unaudited fourth quarter and full year financial results for the period ended December 31, 2013.

Unaudited Fourth Quarter 2013 Financial Highlights (period-over-period comparisons to fourth quarter 2012)

·   Quarterly sales increased by 17.1% to $22.9 million from $19.6 million.

·   Gross profit increased by 34.9% to $14.7 million from $10.9 million. Gross margin was 64.0%, compared to 55.6%.

·   Net income attributable to common stockholders was $5.8 million, or $0.10 per basic and diluted share, compared to net loss attributable to common stockholders of $4.6 million, or $0.08 per basic and diluted share.

Unaudited Full Year 2013 Financial Highlights (Year-over-year comparisons to 2012)

·   Sales increased by 47.4% to $72.5 million from $49.2 million. Excluding revenue recognition of Panflu under government stockpiling program in 2013, regular sales increased by 25.5% to $61.8 million from $49.2 million.

·   Gross profit increased by 70.2% to $51.3 million from $30.1 million. Gross margin increased to 70.7% from 61.2%. Excluding the impact of Panflu sales under the government stockpiling program in 2013, gross margin increased to 72.6% from 61.2%.

·   Net income attributable to common stockholders was $7.4 million, or $0.13 per basic and diluted share, compared to net loss attributable to common stockholders of $14.9 million, or $0.27 per basic and diluted share.

·   Cash and cash equivalents totaled $107.2 million as of December 31, 2013, compared to $91.2 million as of December 31, 2012. Net cash provided by operating activities was $5.7 million in 2013, compared to net cash used by operating activities of $16.3 million in 2012.

Recent Business Highlights

In January 2014, Sinovac submitted a Clinical Trial Application (CTA) with the China Food and Drug Administration (CFDA) to commence human clinical trials for its vaccine against Avian influenza A (H7N9) virus. The CTA was officially accepted by the CFDA on January 29, 2014.

In February 2014, the Phase III clinical trial results for Sinovac's proprietary Enterovirus 71 ("EV71") vaccine were published online in the February 27th issue of The New England Journal of Medicine ("NEJM"). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease ("HFMD"), or herpangina, was 94.8% among infants and young children. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

Mr. Weidong Yin, Chairman, President and CEO, commented, "2013 was a strong year for Sinovac from a commercial vaccines sales standpoint. Total 2013 sales increased by 47.4% and regular sales, excluding the government stockpiling revenue recognition, rose by 25.5%. We generated a net income in excess of $7 million for the full year. Sinovac's sales team continued to execute its tailored sales and marketing strategy in China within a favorable competitive environment."

Mr. Yin concluded, "The publication of phase III clinical trial results in February 2014 further validated our scientific contribution to address this significant unmet need through the development of our proprietary EV71 vaccine against hand foot and mouth disease. Currently, the new drug application for our EV71 vaccine is under technological review by the CFDA. We look forward to supplying the urgently needed vaccine for the control and prevention of HFMD in China and neighboring countries. "

Financial Review for Unaudited Fourth Quarter Ended December 31, 2013

An analysis of sales and gross profit is as follows:

In USD'000
(Unaudited)

 

2013Q4

% of

Sales

2012Q4

%of

Sales

Hepatitis A –

Healive

 

7,970

34.7%

10,038

51.3%

Hepatitis A&B –

Bilive

 

2,846

12.4%

4,177

21.3%

Hepatitis vaccines

 

10,816

47.1%

14,215

72.6%

Influenza vaccines

 

3,409

14.9%

5,336

27.2%

Animal vaccines

 

617

2.7%

15

0.1%

Mumps vaccines

 

934

4.1%

25

0.1%

Regular sales

 

15,776

68.8%

19,591

100%

H5N1

 

7,169

31.2%

-

-

Total sales

 

22,945

100%

19,591

100%

Cost of goods sold

 

8,255

36.0%

8,698

44.4%

Gross profit

 

14,690

64.0%

10,893

55.6%

Fourth quarter 2013 sales increased by 17.1% to $22.9 million from $19.6 million for the same period in 2012. The increase was mainly due to the revenue recognition of Panflu (H5N1) manufactured under the government stockpiling program. Excluding revenue of Panflu (H5N1), sales for the fourth quarter 2013 decreased by 19.5% to $15.8 million, compared to $19.6 million in the same period of 2012. The decrease in regular sales was mainly due to three reasons: 1) 2012 sales included a one-time order of Healive from Gansu province after a natural disaster, so sales of Healive decreased by 20.6% in the fourth quarter of 2013 compared with that of the same period in 2012. 2) Bilive sales decreased by 31.9% due to timing differences of vaccination campaigns. Different from Healive that is part of the regular immunization program in China for infants and young children, Bilive is mainly administered as a booster through vaccination campaigns organized by local CDCs, which results in sales fluctuation from quarter to quarter. Bilive sales for full year of 2013 were higher than 2012; and 3) sales of Anflu decreased by 36.1% as the majority of Anflu sales shifted from the fourth quarter to the third quarter due to early launch of the vaccine during the 2013-2014 flu season.

Compared to the fourth quarter of 2012, the gross profit margin for the fourth quarter of 2013 increased to 64.0% from 55.6%. Higher gross margin was mainly driven by the improved operational management, which resulted in less inventory provision charged to the cost of sales, as well as increased selling price of some of our products.

Selling, general and administrative expenses for the fourth quarter 2013 were $7.9 million, compared to $12.8 million in 2012. The decrease in SG&A expenses was mainly due to lower G&A expenses of ongoing validation of EV71 vaccine facilities and GMP certification preparation.

R&D expenses for the fourth quarter of 2013 were $2.5 million, a $1.2 million increase over the same period in 2012. The Company incurred more expenditures related to the continued advancement of pipeline vaccine candidates, such as pneumococcal polysaccharides vaccine and varicella vaccine, in the fourth quarter of 2013.

Net income attributable to stockholders for the fourth quarter of 2013 was $5.8 million, or $ 0.10 per basic and diluted share, compared to a net loss of $4.6 million, or $0.08 per basic and diluted share, in the same period of last year. Excluding the impact of the bonus revision of $0.6 million, which was paid out or to be paid out from an accrued liability account rather than charged to expenses, the net income for the fourth quarter 2013 was $5.2 million, or $0.09 per basic share and diluted share.

Financial Review for Unaudited Full Year Ended December 31, 2013

In USD'000

(Unaudited)

 

2013

% of

Sales

2012

% of

Sales

           

Hepatitis A –

Healive

 

26,420

36.4%

20,141

40.9%

Hepatitis A&B –

Bilive

 

20,782

28.7%

19,810

40.3%

Hepatitis vaccines

 

47,202

65.1%

39,951

81.2%

Influenza vaccines

 

12,156

16.8%

9,191

18.7%

Animal vaccines

 

750

1.0%

50

0.1%

Mumps vaccines

 

1,680

2.3%

24

0.0%

Regular sales

 

61,788

85.2%

49,216

100%

H5N1

 

10,736

14.8%

-

-

Total sales

 

72,524

100%

49,216

100%

Cost of goods sold

 

21,273

29.3%

19,100

38.8%

Gross profit

 

51,251

70.7%

30,116

61.2%

           

Total sales for 2013 increased by 47.4% to $72.5 million from $49.2 million in 2012. Excluding revenue recognition of Panflu under the government stockpiling program in 2013, regular sales of Healive, Bilive, Anflu, mumps and Rabend increased by 25.5% to $61.8 million in 2013 from $49.2 million in 2012. The increased sales mainly derived from the growth of Healive and Anflu.

Gross profit for 2013 increased by 70.2% to $51.3 million from $30.1 million in 2012. Gross margin increased to 70.7% in 2013 from 61.2% in 2012. Excluding the impact of Panflu sales under the government stockpiling program in 2013, gross margin increased to 72.6% in 2013 from 61.2% in 2012. The reasons for the increased gross profit were the same as discussed under the section of the fourth quarter result discussion.

Selling, general and administrative expenses for 2013 were $32.4 million, which was maintained at a similar level of $31.7 million for 2012.

Research and development expenses in 2013, which primarily represented amounts spent on the advancement of the pipeline vaccines, inclusive of EV71, pneumococcal vaccines, and varicella, decreased to $8.4 million from $17.0 million in 2012. The decrease was mainly due to the completion of the phase III clinical trial of EV71 vaccine candidate in the first quarter of 2013.

Depreciation of property, plant and equipment for 2013 was $2.1 million, compared to $1.6 million for 2012. Depreciation rose in 2013 as more assets at the Changping facility commenced depreciation in the last quarter of 2012.

Net income attributable to stockholders in 2013 was $7.4 million, or $0.13 per basic and diluted share, compared to a net loss of $14.9 million, or $0.27 per basic and diluted share in 2012. Excluding the impact of the bonus revision of $2.4 million, which was paid out or to be paid out from an accrued liability account rather than charged to expenses, net income of 2013 was $5.0 million, or $0.09 per basic share and diluted share.

As of December 31, 2013, cash and cash equivalents totaled $107.2 million, compared to $91.2 million as of December 31, 2012. Net cash provided by operating activities was $5.7 million in 2013. Net cash used in investing activities was $5.2 million in 2013, which was mainly for payment of property, plant and equipment for the Changping facility. Net cash provided by financing activities was $14.3 million in 2013, including loan proceeds of $16.8 million.

Conference Call Details

The Company will host a conference call on Thursday, March 20, 2014 at 8:00 a.m. EDT (March 20, 2014 at 8:00 p.m. China Standard Time) to review the Company's financial results and provide an update on recent corporate developments. To access the conference call, please dial 1-877-407-0784 (USA) or 1-201-689-8560 (International). A replay of the call will be available from 11 a.m. EDT on March 20, 2014 to April 3, 2014 at midnight. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517 (International) and reference the replay pin number 13578265.

A live audio webcast of the call will also be available from the investors section on the corporate web site at www.sinovac.com. A webcast replay can be accessed on the corporate website beginning March 20, 2014 and the replay will remain available for 30 days.

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 including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial for enterovirus 71 (against hand, foot and mouth disease) and filed new drug application with China Food & Drug Administration. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license to commercialize seasonal flu vaccine in Mexico.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9659/9696
Fax: +86-10-6296-6910
Email:
ir@sinovac.com

Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email:
scarrington@theruthgroup.com

Media:
Aaron Estrada
The Ruth Group
Tel: +1-646-536-7028
Email:
aestrada@theruthgroup.com

SINOVAC BIOTECH LTD.

   

Consolidated Statements of Balance Sheets

 

(Unaudited)

   

December 31, 2013 and 2012

   

(Expressed in thousands of U.S. Dollars)

   
     

Current assets

December 31, 2013

December 31, 2012

Cash and cash equivalents

107,242

91,241

Accounts receivable

31,927

23,440

Inventories

14,399

10,530

Prepaid expenses and deposits

1,131

1,072

Due from related party

19

-

Deferred tax assets

2,602

-

Total current assets

157,320

126,283

     

Property, plant and equipment

78,911

80,083

Long-term inventories

2,711

28

Long-term prepaid expenses

154

290

Prepayments for acquisition of equipment

708

483

Deferred tax assets

117

446

Licenses

772

1,150

Total assets

240,693

208,763

     

Current liabilities

   

Loans payable

16,217

3,329

Due to related party

3,324

-

Accounts payable and accrued liabilities

28,037

24,778

Income tax payable

246

239

Deferred revenue

875

1,378

Deferred government grants

444

431

Total current liabilities

49,143

30,155

     

Deferred government grants

4,760

4,069

Loans payable

32,146

31,181

Due to related party

-

3,230

Deferred revenue

11,005

10,693

Total long term liabilities

47,911

49,173

     

Total liabilities

97,054

79,328

     

Commitments and contingencies

   

Stock holder's equity

   

Preferred stock

-

-

Common stock

56

55

Additional paid in capital

107,393

106,246

Accumulated other comprehensive income

14,141

11,771

Statutory surplus reserves

11,808

11,808

Accumulated deficit

(4,714)

(12,156)

Total stockholders' equity

128,684

117,724

     

Non-controlling interests

14,955

11,711

Total equity

143,639

129,435

Total liabilities and equity

240,693

208,763

SINOVAC BIOTECH LTD.

           

Consolidated Statements of Operations and Comprehensive Income (loss)

     

Three and Twelve Months Ended December 31, 2013 and 2012

       

(Unaudited)

           

(Expressed in thousands of U.S. Dollars, expect for per share figures)

       
   

Three months ended
December 31

 

Twelve months ended
December 31

   

2013

2012

 

2013

2012

             

Sales

 

22,945

19,591

 

72,524

49,216

Cost of sales

 

8,255

8,698

 

21,273

19,100

Gross profit

 

14,690

10,893

 

51,251

30,116

             
             

Selling, general and administrative expenses

 

7,861

12,820

 

32,432

31,685

(Recovery) for doubtful accounts

 

(1,561)

(971)

 

(504)

(874)

Research and development expenses

 

2,461

1,251

 

8,384

17,044

Depreciation of property, plant and equipment

 

33

540

 

2,106

1,595

Loss on disposal and impairment of property, plant and

equipment

 

91

2,191

 

88

2,191

Government grants recognized in income

 

-

181

 

-

(374)

Total operating expenses

 

8,885

16,012

 

42,506

51,267

Operating income (loss)

 

5,805

(5,119)

 

8,745

(21,151)

             

Interest and financing expenses

 

(863)

(631)

 

(3,031)

(775)

Interest income

 

600

809

 

2,168

2,370

Other income (expenses)

 

121

(163)

 

263

(77)

Income (loss) before income taxes and non-

controlling interests

 

5,663

(5,104)

 

8,145

(19,633)

Income tax recovery

 

2,287

89

 

2,225

884

             

Consolidated net income (loss)

 

7,950

(5,015)

 

10,370

(18,749)

Net (income) loss attributable to the non-controlling interests

(2,129)

405

 

(2,928)

3,896

Net income (loss attributable to stockholders

 

5,821

(4,610)

 

7,442

(14,853)

Net Income (loss)

 

7,950

(5,015)

 

10,370

(18,749)

Other comprehensive income

           

Foreign currency translation adjustment

 

1,086

968

 

2,687

2,024

Total comprehensive income (loss)

 

9,036

(4,047)

 

13,057

(16,725)

Less: comprehensive (income) loss attributable to non-

controlling interests

 

(2,279)

314

 

(3,244)

3,665

Comprehensive income (loss) attributable to stockholders

 

6,757

(3,733)

 

9,813

(13,060)

             

Weighted average number of shares of common

stock outstanding

           

Basic

 

55,497,357

55,037,264

 

55,301,276

54,926,440

Diluted

 

56,057,462

55,037,264

 

55,802,338

54,926,440

             

Earning (loss) per share

           

Basic

 

0.10

(0.08)

 

0.13

(0.27)

Diluted

 

0.10

(0.08)

 

0.13

(0.27)

               

 

SINOVAC BIOTECH LTD.

         

Consolidated Statement of Cash Flows

         

Three and Twelve Months Ended December 31, 2013 and 2012

       

(Unaudited)

         

(Expressed in thousands of U.S. dollars)

         
 

Three months ended
December 31

 

Twelve months ended
December 31

 

2013

2012

 

2013

2012

Cash flows provided byused in) operating activities:

       

Net income (loss)

7,950

(5,015)

 

10,370

(18,749)

Adjustments to reconcile net income (loss) to net cash

provided by (used in) operating activities:

         

Deferred income tax

(2,287)

(89)

 

(2,225)

(17)

Stock-based compensation

72

(41)

 

281

347

Inventory provision

629

2,114

 

1,399

3,479

Recovery of doubtful accounts

(1,561)

(971)

 

(504)

(874)

Impairment of equipment and loss on disposal

(349)

2,185

 

88

2,191

Unrealized foreign exchange gain

-

44

 

-

-

Research and development expenditures qualified for government grant

-

421

 

-

(125)

Depreciation of property, plant and equipment

1,706

814

 

6,842

4,487

Deferred government grants recognized in income

-

(358)

 

-

(358)

Accretion expenses

47

50

 

100

235

Changes in:

-

0

 

-

-

Accounts receivable

8,197

3,017

 

(7,256)

(4,286)

Inventory

(1,624)

3,715

 

(7,547)

(426)

Income tax payable

-

(5)

 

-

(3,130)

Prepaid expenses and deposits

415

(136)

 

242

913

Deferred revenue

4,037

(330)

 

(675)

1,026

Accounts payables and accrued liabilities

2,684

2,774

 

4,559

(967)

Net cash provided by (used in) operating activities

19,916

8,189

 

5,674

(16,254)

           

Cash flows provided by financing activities:

         

Loan proceeds

2,942

9,489

 

16,800

16,787

Loan repayments

(3,927)

(4,755)

 

(4,089)

(4,755)

Proceeds from issuance of common stock, net of share issuance costs

85

109

 

842

508

Proceeds from shares subscribed

-

(27)

 

-

8

Government grants received

149

2,154

 

745

2,395

Dividends paid to non-controlling shareholder of Sinovac Beijing

-

(3)

 

-

(802)

Loan from non-controlling shareholder of Sinovac Dalian

-

12

 

-

3,189

Net cash provided by financing activities

(751)

6,979

 

14,298

17,330

           

Cash flows used in investing activities:

         

Proceeds from disposal of equipment

-

-

 

-

5

Acquisition of property, plant and equipment

(1,739)

(5,215)

 

(5,176)

(16,156)

Net cash used in investing activities

(1,739)

(5,215)

 

(5,176)

(16,151)

           

Exchange gain (loss) on cash and cash equivalents

790

(674)

 

1,205

2,029

           

Increase in cash and cash equivalents

18,216

9,279

 

16,001

(13,046)

           

Cash and cash equivalents, beginning of year

89,026

81,962

 

91,241

104,287

           

Cash and cash equivalents, end of year

107,242

91,241

 

107,242

91,241

 

 

 

 

 

 

 

       
     
   

RELATED CONTENT

 

About SINOVAC

 

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

 

SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.

 

The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

 

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.

 

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

 

For more information, please see the Company’s website at www.sinovac.com.

 

Contact:

Sinovac Biotech Ltd. 

PR Team 

pr@sinovac.com