EX-99.1 2 sinovacexh99_1.htm SINOVAC BIOTECH 6K, PRESS RELEASE, 06.15.09 sinovacexh99_1.htm


Exhibit 99.1
Sinovac Reports Unaudited First Quarter 2009 Financial Results
 
- Conference call scheduled Friday, May 15, 2009 at 9:00 a.m. ET-
- Reaffirmation of 2009 sales projection to be $55 million to $60 million-
 
BEIJING, May 15 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China has announced its unaudited financial results for the three-month period ended March 31, 2009.
 
Recent Highlights
 
-- In April 2009, Sinovac won the bidding to be the sole provider of approximately $12.8 million (2.41 million doses) worth of the inactivated hepatitis A vaccine, Healive, to China's Ministry of Public Health (MOH) for a vaccination campaign.
 
-- Sinovac has initiated preparatory activities for production of a vaccine for the new influenza A (H1N1) strain. Sinovac is engaged in ongoing correspondence with international organizations and other governmental bodies regarding H1N1.
 
-- In May 2009, Sinovac filed a registration dossier for a split pandemic influenza vaccine with the China state Food and Drug Administration (SFDA) to ensure children and juveniles are protected during an influenza pandemic.
 
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We continue to leverage our R&D capabilities to fuel future growth. Our new R&D center is operating now, which will speed up our R&D process. Our objective for the next three to five years is to have one or two product candidates per year entering into clinical trials beginning in 2010 and one or two products launched into the market per year commencing in 2012. In addition to our organic growth strategy, with $23 million of cash and cash equivalents we have financial flexibility to selectively pursue acquisition candidates that will help to expand our product pipeline. Although we are experiencing the effects of the global financial crisis, we are confident that our balance sheet will support the strategic acquisition and integration of businesses that will strengthen our foundation for rapid development.
 
"We are very excited about our growth prospects for 2009 despite a sales shortfall in the first quarter. Our sales budget for 2009 is heavily weighted towards the second half of the year. We continue to focus our sales efforts on driving growth in the private pay market, as we further penetrate less developed areas of China. Additionally, in the beginning of the year, we successfully won the bid for the MOH purchase of hepatitis A vaccines, providing Sinovac with an entrance into the public market. Being awarded this contract is a major achievement that demonstrates the success of our strategy to pursue public market opportunities. We believe that Sinovac will perform well in both the public and private markets in 2009. Our 2009 sales projections are in the range of $55 million to $60 million, which is approximately a 20% increase over 2008 sales.
 
Mr. Yin continued, "In addition, the outbreak of influenza A (H1N1) has created potential opportunities for Sinovac. Our R&D capability makes us the only manufacturer in China with the license to produce pandemic influenza vaccines. In response to the global outbreak, we have initiated preparatory activities for the production of a vaccine for the new virus strain. We remain focused on updates from international organizations about the spread of this
 
 
 

 
 
virus and for the reassortant strain needed for vaccine production; we are also keeping in close contact with the Chinese government. We believe that our proven technological and operational expertise, production capacity and financial flexibility will support our ability to supply vaccines for H1N1 should the need arise. We also have a robust pipeline of other vaccines for other infectious diseases, including enterovirus 71, conjugated pneumococcal vaccine, and Japanese encephalitis, which we anticipate will drive longer-term revenue growth."
 
Financial Review for Three Months Ended March 31, 2009
 
During the first quarter of 2009, sales were $6.6 million, compared to $8.9 million in the first quarter of 2008. Sinovac continues to devote significant resources to marketing Healive to China's private market and an increase in demand for Healive in the public market is expected. The public market operates differently from the private market, which will impact the seasonality of the Company's sales.
 
During the first quarter of 2009, Sinovac's unit dose sales were:
 
Three months ended March 31     2009     2008  
    (doses)     (doses)  
Healive      772,000       1,500,000  
Bilive      176,000       31,000  
Anflu       155,000       23,500  
 
The hepatitis A vaccine market in China is currently experiencing a transitional period; it has previously been only private market but now private and public markets co-exist. In response to the market transition, Sinovac has adjusted its sales and marketing strategy for Healive in order to enter into the public market. In April, Sinovac won the MOH bid, marking the Company's entry into the public market. Since Sinovac had previously focused solely on the private market, it expects it will take some time to build up its position in the public market. Additionally, in the first quarter of 2009, due to a government mandate, China CDC largely devoted its resources to other vaccination programs which has adversely impacted sales of Healive and affected Sinovac's first quarter sales. Sales of Bilive increased significantly during the quarter and the Company expects it to become a complementary product to Healive in the private market, whereas Healive is expected to increasingly penetrate the public market.
 
Gross profit for the first quarter 2009 was $5.1 million, with a gross margin of 78%, compared to $7.8 million and a gross margin of 88%, for the same period of 2008. The gross margin was adversely impacted by the decreasing percentage of Healive sales in total sales revenue, as Healive has the highest gross margin among the three products. The gross margin for the first quarter was relatively flat with the fourth quarter gross margin of 79%.
 
Total operating expenses for first quarter of 2009 were $4.5 million, compared to $4.7 million in the comparative period in 2008. Selling, general and administrative expenses for the first quarter of 2009 were $3.5 million, compared to $3.6 million in the same period of 2008. The SG&A reflects investments in sales and marketing, consulting, travel and other expenses to execute the Company's growth strategy for 2009 and beyond. SG&A expenses, as a percentage of first quarter 2009 sales, increased to 54%, compared to 40% during the prior year. Selling expense decreased in tandem with the lower sales revenue, but G&A increased primarily due to higher bad debt expense. In addition, in
 
 
 

 
 
January 2009, Sinovac granted about 1.7 million options to its employees, which incurred stock based compensation in the quarter.
 
Net research and development expenses for the first quarter 2009 were $759,000, compared to $929,000 in the same period of 2008. R&D expenses in the first quarter of 2009 mainly related to the advancement of pre-clinical stage vaccine candidates against enterovirus 71, human rabies, Japanese encephalitis animal rabies and split pandemic influenza vaccines.
 
First quarter 2009 operating income was $646,000, compared to an operating income of $3.1 million in the prior year. Net income for the first quarter of 2009 included $482,000 in income tax expenses, $126,200 in net interest and financing expenses and $107,000 of minority interest. Net income for the same period of 2008 included $158,000 of net interest expense, $719,000 of income taxes expense, and $0.7 million of minority interest. The net income for first quarter of 2009 was $25,000, or $0.00 per diluted share, compared to net income of $1.6 million, or $0.04 per diluted share, in the same period of 2008.
 
As of March 31, 2009, Sinovac's cash and cash equivalents totaled $23.3 million, compared to $32.9 million as of December 31, 2008. The decrease in cash and cash equivalents primarily reflects investment in working capital and equipment purchases for the new R&D center in Beijing. Due to the economic downturn, government agencies delayed payment due to reduced government income; Sinovac does expect to collect on these receivables later this year.
 
Recent Developments
 
In April 2009, Sinovac announced that it won the MOH's procurement bid for hepatitis A vaccine worth approximately RMB 87 million or $12.8 million. A part of the government's large-scale efforts to improve public health, the hepatitis A vaccination program will cover young children aged 18 months to 12 years in 32 cities or counties in nine provinces.
 
The government order for a total of 2.41 million doses was comprised solely of inactivated vaccines due to their higher safety profile, comprising 1.79 million doses to be delivered in the form of pre-filled syringes (PFS) for ease of application and 620,000 vial doses. Sinovac is the sole supplier of the hepatitis A vaccine in this program. In 2008, Sinovac, through China's MOH, supplied its hepatitis A vaccine, Healive, in the Sichuan earthquake disaster area. Sinovac's role in the relief effort helped Healive to gain recognition as a safe and high-quality vaccine against the hepatitis A virus.
 
Also in April 2009, Sinovac responded to the global influenza A (H1N1) outbreak by initiating preparatory activities for the production of a vaccine for the new H1N1 strain. Sinovac has contacted various Chinese government authorities and global health organizations in order to closely monitor the disease and evaluate strategies to control and prevent its transmission. In May, high ranking government officials visited Sinovac to gain a better understanding of our capacity to produce the H1N1 vaccine. In 2008, following the receipt of a Chinese government grant, Sinovac expanded its annual manufacturing capacity for its pandemic influenza vaccine, Panflu(TM), to 20- 30 million doses; these facilities can also be leveraged in the development of a new H1N1 flu vaccine. Sinovac expects to receive the H1N1 virus strain by the end of May, which would enable the Company to commence manufacturing the vaccine as needed. In addition to Chinese authorities, Sinovac has also received inquiries from other countries and regions. Sinovac has filed its application for a pandemic influenza (H5N1) vaccine in Hong Kong and submitted an influenza vaccine dossier to its distribution partner in India.
 
 
 

 
 
In May, Sinovac filed a registration dossier for a split pandemic influenza vaccine with the China SFDA to ensure children and juveniles are protected during an influenza pandemic. This is a complementary product to the Company's whole viron pandemic influenza vaccine, Panflu, protects adults from this virus and was approved in April 2008. SFDA has initiated the review and approval process for the split pandemic influenza vaccine and expects to receive the approval shortly. Once Sinovac receives approval, the Company's vaccines that protect larger age groups from pandemic influenza.
 
In addition, Sinovac is expanding beyond the human vaccine market by entering into the animal vaccine market as there is a sizable market opportunity for animal vaccines. Tangshan Yian, Sinovac's wholly owned subsidiary, is focusing on the animal vaccine business to help drive growth. In January 2009, the Company obtained approval from China's Ministry of Agriculture to conduct field trials of internally developed inactivated animal rabies vaccine, which are currently on schedule. In the first quarter, over 10,000 dogs were immunized with Sinovac's vaccine candidates, demonstrating that the vaccine has a good safety profile. Sinovac expects the vaccine to be launched into the market in 2010.
 
Conference Call Details
 
The Company will host a conference call on Friday, May 15, 2009 at 9:00 a.m. ET (9 p.m. China Standard Time) to review the Company's first quarter financial results for the period ended March 31, 2009 and provide an update on recent corporate developments. To access the conference call, please dial 1-877-407-4018 (USA) or 1-201-689-8471 (international). A replay of the call will be available from 12:00 p.m. ET on May 15, 2009 until May 29, 2009. To access the replay, please dial 1-877-660-6853 (USA) or 1-201-612-7415 (international) and reference the account number 3055 and the access code 322891. A live audio webcast of the call will also be available from the Investors section on the corporate web site at http://www.sinovac.com . A webcast replay can be accessed on the corporate website beginning May 15, 2009 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, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's vaccine products include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenza vaccine (H5N1), has already been approved for government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis vaccine, and human rabies vaccine. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.
 
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.
 
 
 

 
 
SINOVAC BIOTECH LTD.
           
Incorporated in Antigua and Barbuda
       
Consolidated Balance Sheets
       
March 31, 2009
           
Unaudited
           
(Expressed in U.S. Dollars)
 
             
   
March 31, 2009
   
December 31, 2008
 
ASSETS
           
             
Current assets
           
Cash and cash equivalents
  $ 23,308,879     $ 32,894,102  
Accounts receivable - net
    21,105,032       19,486,596  
Inventories
    9,770,267       7,428,865  
Income tax refundable
    1,233,824       348,018  
Prepaid expenses and deposits
    903,454       933,297  
Deferred tax assets
    1,022,078       1,189,831  
Total current assets
    57,343,534       62,280,709  
Property, plant and equipment
    20,564,504       19,262,099  
Deferred tax asset
    580,296       569,937  
Licenses and permits
    992,444       1,090,477  
Due to from related party
    1,460,792       -  
Total assets
  $ 80,941,570     $ 83,203,222  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
         
Current liabilities
               
Loans payable
  $ 8,034,358     $ 8,024,277  
Accounts payable and accrued liabilities
    9,789,984       11,909,037  
Due to related parties
    46,971       46,971  
Dividends payable to minority interest shareholder of Sinovac Beijing
    115,822       115,677  
Deferred research grants
    1,126,236       1,182,703  
Total current liabilities
    19,113,371       21,278,665  
 
 
 
 

 
 
 
Loans payable
    2,191,189       2,188,439  
Deferred government grants
    2,788,869       2,836,994  
Total long-term liabilities
    4,980,058       5,025,433  
Total liabilities
    24,093,429       26,304,098  
                 
EQUITY
               
Shareholders' equity
               
Preferred stock
    -       -  
Authorized 50,000,000 shares at par value of $0.001 each, issued and outstanding: nil
 
Common stock
    42,725       42,894  
Authorized 100,000,000 shares at par value of $0.001 each, issued and outstanding: 42,725,356
 
Additional paid-in capital
    41,376,534       41,629,506  
Accumulated other comprehensive income
    4,208,124       4,143,225  
Dedicated reserves
    5,549,684       5,549,684  
Accumulated deficit
    (1,626,855 )     -1,651,534  
Total shareholders' equity
    49,550,212       49,713,775  
Noncontrolling interest
    7,297,929       7,185,349  
Total equity
    56,848,141       56,899,124  
Total liabilities and equity
  $ 80,941,570     $ 83,203,222  
 
 
 
SINOVAC BIOTECH LTD.
             
Incorporated in Antigua and Barbuda
             
Consolidated Statements of Operations and Comprehensive Income
             
Three months ended March  31, 2009 and 2008
             
Unaudited
             
(Expressed in U.S. Dollars)    
               
 
 
2009
 
 
 
2008
 
Sales
  $ 6,566,099       $ 8,862,001  
Cost of sales
                 
exclusive of depreciation of land use right and amortization of licenses and permits of $104,633 (2008 - $99,834)
    1,447,770  
 
    1,047,866  
Gross Profit
    5,118,329  
 
    7,814,135  
                   
Selling, general and administrative expenses
    3,547,623         3,577,886  
 
 
 
 

 
 
 
Research and development expenses
                 
net of $58,311(2008 - $4,019) in government research grants
    759,441         929,336  
   
 
 
 
 
 
 
Depreciation of property, plant and equipment and amortization of licenses and permits
    164,869  
 
    178,229  
                   
Total Operating Expenses
    4,471,933  
 
    4,685,451  
                   
Operating Income
    646,396  
 
    3,128,684  
                   
Interest and financing expenses
    (126,200 )       (157,707 )
                   
Interest and other income
    93,131  
 
    46,350  
                   
Income before income taxes
    613,327         3,017,327  
                   
Income taxes expenses
    481,768  
 
    718,516  
                   
Net income for the period
    131,559         2,298,811  
                   
Net income attributable to noncontrolling interest
    (106,880 )       (738,855 )
                   
Net income attributable to shareholders
  $ 24,679       $ 1,559,956  
                   
Net income for the period
  $ 131,559       $ 2,298,811  
                   
Other comprehensive income
                 
Foreign currency translation adjustment
    64,899  
 
    1,282,528  
Comprehensive income
    196,458  
 
    3,581,339  
                   
Comprehensive income attributable to noncontrolling Interest
    123,043         1,009,418  
Comprehensive income attributable to shareholders
  $ 73,415       $ 2,571,921  
                   
Earnings per share – basic and diluted
  $ 0.00       $ 0.04  
Weighted average number of shares of common stock outstanding
                 
Basic
    42,890,695         41,088,322  
Diluted
    42,890,695  
 
    41,470,579  
 
 
 
 

 
 
SINOVAC BIOTECH LTD.
               
Incorporated in Antigua and Barbuda
               
Consolidated Statements of Cash Flows
               
Three months ended March  31, 2009 and 2008
               
Unaudited
               
(Expressed in U.S. Dollars)          
                 
 
 
 
2009
 
 
 
2008
 
Cash Flows From Operating Activities
               
Net income for the period
    $ 24,679       $ 1,559,956  
Adjustments to reconcile net income to net cash provided (used) by operating activities:
                   
- deferred income taxes
      157,394         73,181  
- gain on disposal of equipment
      (9,783 )       -  
- stock-based compensation
      66,503         16,636  
- provision for doubtful accounts
      868,938         627,805  
- depreciation of property, plant and equipment, and amortization of licenses and permits
      432,354         392,103  
- research and development expenditures qualified for  government grant
    (58,311 )       (4,019 )
- noncontrolling interests
      106,880         738,855  
  Change in other assets and liabilities
                   
- accounts receivable
      (2,462,999 )       (4,150,245 )
- inventories
      (2,331,763 )       (1,449,443 )
- prepaid expenses and deposits
      30,904         319,014  
- income tax refundable
      (885,252 )       -  
- accounts payable and accrued liabilities
      (2,771,775 )       473,790  
 Net Cash Used in Operating Activities
 
    (6,832,231 )
 
    (1,402,367 )
                     
 Cash Flows From Financing Activities
                   
Proceeds from issuance of common stock
      -         9,751,309  
Proceeds from shares subscribed
      -         61,990  
Repurchase of common stock
      (319,643 )       -  
Loan to minority shareholders in Sinovac Beijing
      (1,460,600 )       -  
Dividend paid to minority shareholders in Sinovac Beijing
      -         (2,947,877 )
 Net Cash Provided by / (Used in) Financing Activities
 
    (1,780,243 )
 
    6,865,422  
                     
 Cash Flows From Investing Activities
      -         -  
Restricted cash
      -         (1,370,686 )
Acquisition of property, plant and equipment
      (1,011,492 )       (1,007,424 )
 Net Cash Used in Investing Activities
 
    (1,011,492 )
 
    (2,378,110 )
 Exchange Gain on Cash and Equivalents
 
    38,743  
 
    422,270  
 (Derease) / Increase in cash and cash equivalents
      (9,585,223 )       3,507,215  
 Cash and Cash Equivalents, Beginning of Period
      32,894,102         17,071,497  
 Cash and Cash Equivalents, End of Period
    $ 23,308,879       $ 20,578,712  
 
 
 
 

 
 
 
Supplemental Disclosure of Cash Flow Information:
                   
Cash paid for income taxes
    $ 1,209,626       $ 438,406  
Cash paid for interests
    $ 123,402       $ 110,841  
                     
Supplemental Schedule of Non-cash Activities:
                   
Acquisition of property, plant and equipment included in accounts payable and accrued liabilities
    $ 1,092,789       $ 822,696