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Sinovac Reports Unaudited Third Quarter 2009 Financial Results
Date:11/15/2009

BEIJING, Nov. 15 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading developer and provider of vaccines, announced today its unaudited financial results for the three-month and nine-month periods ended September 30, 2009.

Financial Highlights

  • Sales for the third quarter increased 142% to $21.2 million
  • Sales for the nine-month period increased 40% to $47.8 million
  • Operating income for the third quarter rose 436% to $12.4 million
  • Operating income for the nine-month period increased 90% to $23.7 million.
  • Net income attributable to the shareholders increased 606% to $5.2 million in the third quarter, with diluted EPS of $0.12
  • Cash and cash equivalents at September 30, 2009 was $46.6 million.

Business Highlights

  • In August, Sinovac reported positive top-line results from the completed clinical trial for its internally-developed pandemic influenza A (H1N1) vaccine, PANFLU.1(TM). The analysis of the clinical trial results showed that Sinovac's H1N1 vaccine induces good immunogenicity after one dose. The seropositive rate, seroconvertive rate and GMT increasing multiple conform to international criteria for vaccines, which indicated PANFLU.1 has a good safety and immunogenicity profile.
  • In August, Sinovac was selected by the Beijing Public Health Bureau as one of four manufacturers to supply seasonal influenza vaccine to the citizens of Beijing. The Beijing Public Health Bureau completed the bidding process for the purchase of flu vaccines and corresponding services for 2009 on August 26, 2009. Sinovac will supply its seasonal influenza vaccine, Anflu®, pursuant to this agreement.
  • In September, Sinovac's registration application for its pandemic influenza A (H1N1) vaccine, PANFLU.1(TM), was approved by the State Food and Drug Administration (SFDA) and a production license was granted. Sinovac received a first purchase order for 3.3 million doses and a second order purchase for 3.0 million doses on September 4 and September 30, respectively, from China's Ministry of Industry and Information Technology for the national purchase plan. In October, Sinovac received a third purchase order for 5.19 million doses. In aggregate, Sinovac has received orders for a total of 11.49 million doses of its PANFLU.1(TM) vaccine for China's national purchase plan.
  • In September, Sinovac signed an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac's H1N1 vaccine. The agreement followed meetings between Sinovac and the Korean Food and Drug Administration (KFDA) and the Korean Center for Disease Control (KCDC) where Sinovac presented the scientific data of Sinovac's H1N1 vaccine. The collaboration provides Boryung exclusive rights to represent Sinovac in discussions with the KFDA and KCDC in the development of business opportunities in South Korea surrounding Sinovac's H1N1 vaccine.
  • In October, Sinovac obtained a Certificate of Approval from Mexico's Secretaria de Salud to distribute PANFLU.1 in Mexico. Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in the Mexican market, pursuant to a prior distribution agreement signed in 2005 with its affiliate. An application for Anflu was filed in Mexico as well.
  • In October, Sinovac received the Certificate of Approval to distribute its H5N1 (bird flu) pandemic influenza vaccine in Hong Kong. The Company plans to submit applications in Hong Kong for approval of its PANFLU.1 (H1N1) and Anflu vaccines in the coming months.
  • In October, Sinovac was selected to supply its seasonal flu vaccine, Anflu®, to the Shanghai government. This marks Sinovac's entry into an additional new public market for its seasonal flu vaccine.
  • In November, Sinovac was selected among five vaccine manufacturers by the Shanghai Government to supply its hepatitis A vaccine, Healive®, to the public market of Shanghai. Sinovac will supply Healive valued at RMB 20.6 million, or approximately $3 million, pursuant to the purchase order that will be in effect for one year.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are very proud that Sinovac was the first company in the world to develop a vaccine for the H1N1 pandemic flu virus. This achievement was made possible by the Company's focus on its mission to provide Chinese children with the best vaccines in the world, and let children in the world benefit from vaccines made in China. To this end, we have not only acted as a successful provider of H1N1 vaccine to China, but have also made strides toward providing other markets such as South Korea and Mexico with PANFLU.1.

"Sinovac has been able to demonstrate its flexibility and agility as a leading vaccine Company by excelling in the rapid development and production of this new product, while, at the same time, also realizing product orders for Anflu and the H5N1 Panflu vaccine, both inside and outside of China. We will continue to leverage our leadership position in the development of the H1N1 vaccine to pursue international marketing opportunities for our entire vaccine portfolio. We will also continue our development efforts to expand our portfolio of marketed vaccines, such as EV71, pneumococcal conjugated vaccine, and rabies, in the coming years."

Mr. Yin concluded, "Our strong third quarter results were a testament to our ability to commercialize our H1N1 and H5N1 vaccines. We recorded revenues from doses sold in China and Macau. Given our strong product mix, we were able to maintain our gross profit margin in excess of 80%. With the continued execution of our commercialization strategy, we remain on track to exceed the previously projected full year 2009 revenue range of $55 million to $60 million."

Market Overview

The People's Republic of China (PRC) government's expansion program of publicly funded inoculations has driven increased demand for Sinovac's principal product, Healive. Although the gross margin on public sales is lower than on private sales, Sinovac expects to realize volume-related offsetting cost savings and efficiencies.

In the current year, Sinovac expects to generate significant revenues from the sale of its H1N1 vaccine; this is expected to be a short-term initiative that will extend through to the end of the influenza season in the spring of 2010. These sales are not expected to be recurring, but demonstrate the Company's ability to develop, manufacture and distribute vaccines on short notice.

At the same time, the outbreak of H1N1 pandemic flu appears to have increased the demand for seasonal flu vaccines. It is expected that increasing sales of Anflu will benefit the company over the long-term.

Financial Review for Three Months Ended September 30, 2009

During the third quarter of 2009, sales were $21.2 million, up 142% from $8.7 million in the third quarter of 2008. During the third quarter of 2009, Sinovac's unit dose sales were:

    Three months ended September 30,               2009              2008
                                               (000 doses)       (000 doses)
                                               -----------       -----------
    Healive                                         989             1,087

    Bilive                                          215                28

    Anflu                                         4,312               512

    Panflu (H5N1)                                    20                 0

    PANFLU.1 (H1N1)                                 586                 0

Sales of the hepatitis A vaccine to the public market (including doses purchased by the Ministry of Health) accounted for 31% of total hepatitis A vaccine sales in the quarter. Sales of Bilive increased significantly during the quarter due to a successful marketing campaign. Sales revenues for 20,000 doses of Panflu (H5N1) to Macau and 586,000 doses of PANFLU.1 (H1N1) were booked during the third quarter of 2009.

Gross profit for the third quarter 2009 was $17.5 million, with a gross margin of 83%, compared to $7.1 million and a gross margin of 81%, for the same period of 2008. The gross margin was favorably impacted by the utilization of the Anflu production line to produce PANFLU.1 (H1N1) and Panflu (H5N1). The gross margin for the third quarter of 2009 increased from the gross margin of 81% reported in the third quarter of 2008 due to efficiencies resulting from expanded production volume of Bilive and increased utilization of the flu production line.

Total operating expenses for the third quarter of 2009 were $5.1 million, compared to $4.8 million in the comparative period in 2008. Selling, general and administrative expenses for the third quarter of 2009 were $3.5 million, compared to $3.8 million in the same period of 2008. SG&A expenses as a percentage of third quarter 2009 sales decreased to 17%, down from 43% during the prior year. The lower selling and administrative expenses as a percentage of revenue resulted from the increased economies of scale associated with the significant growth of sales.

Net research and development expenses for the third quarter 2009 were $1.4 million, compared to $812,000 in the same period of 2008. The increased R&D expenses in the third quarter of 2009 were mainly related to the completion of the H1N1 clinical trial and the continued development of the EV 71 vaccine, pneumococcal conjugated vaccine, and universal pandemic influenza vaccine.

Third quarter 2009 operating income was $12.4 million, compared to operating income of $2.3 million in the prior year. Net income for the third quarter of 2009 included $246,000 interest and financing expenses and $3.8 million in income tax expenses. Net income for the same period of 2008 included $190,000 of interest and financing expenses and $911,000 of income tax expenses. Net income attributable to shareholders for third quarter of 2009 was $5.2 million, or $0.12 per diluted share, up 606% compared to net income attributable to shareholders of $740,000, or $0.02 per diluted share, in the same period of 2008.

As of September 30, 2009, Sinovac's cash and cash equivalents totaled $46.6 million, compared to $32.9 million as of December 31, 2008. The increase in cash and cash equivalents primarily reflects an advance payment received for a vaccine-stockpiling program.

Financial Review for Nine Months Ended September 30, 2009

During the nine months ended September 30, 2009, sales were $47.8 million, up 40% from $34.1 million for the same period in 2008. Sinovac recorded strong revenues growth in the second and third quarters, which greatly improved the Company's performance for the year to date.

During the first nine months of 2009, Sinovac's unit dose sales were:

    Nine months ended September 30             2009              2008
    ------------------------------             ----              ----
                                           (000 doses)       (000 doses)
                                           -----------       -----------
    Healive                                   5,024             5,313

    Bilive                                      708               234

    Anflu                                     4,448               498

    Panflu (H5N1)                                20                 0

    PANFLU.1 (H1N1)                             586                 0

Gross profit for the nine-month period was $38.9 million, with a gross margin of 81%, compared to $28.8 million and a gross margin of 84%, for the prior year period. The gross margin was adversely affected by the lower selling price of Healive vaccine delivered to the Ministry of Health, of which 2.08 million doses was delivered in the second quarter of 2009. Total operating expenses for the first nine months of 2009 were $15.2 million, compared to $16.3 million in the comparative period in 2008.

Selling, general and administrative expenses for the first nine months of 2009 were $12.0 million, compared to $13.4 million in the prior year period. SG&A expenses as a percentage of sales decreased to 25%, down from 39% in the comparative period of the prior year. Net research and development expenses for the first nine months of 2009 were $2.8 million, compared to $2.4 million in the prior year period.

Operating income for the nine months ended September 30, 2009 was $23.7 million, compared to an operating income of $12.5 million in the prior year period. Net income for the first nine months of 2009 included $571,000 in interest and financing expenses and $6.4 million in income tax expenses. Net income for the same period of 2008 included $747,000 of interest and financing expense and $3.2 million of income tax expense. Net income attributable to shareholders for the first nine months of 2009 was $11.1 million, or $0.26 per diluted share, compared to net income of $5.6 million, or $0.13 per diluted share, in the same period of 2008.

Conference Call Details

The Company will host a conference call on Monday, November 16, 2009 at 9:00 a.m. EDT (10:00 p.m. China Standard Time) to review the Company's third quarter financial results for the period ended September 30, 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 November 16, 2009 until November 30, 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 337401. 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 November 16, 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 commercialized vaccine products include Healive® (hepatitis A), Bilive® (combined hepatitis A and B), Anflu® (seasonal influenza), Panflu(TM) (pandemic influenza (H5N1)), and PANFLU.1(TM) (pandemic influenza A (H1N1)). Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, pneumococcal infection, Japanese encephalitis, and human rabies. 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.

    Helen G. Yang
    Sinovac Biotech Ltd.
    Tel:  +86-10-8289-0088 x9871
    Fax:  +86-10-6296-6910
    Email:  info@sinovac.com

    Investors:
    Amy Glynn/Stephanie Carrington
    The Ruth Group
    Tel:  +1-646-536-7023/7017
    Email:  aglynn@theruthgroup.com
    scarrington@theruthgroup.com

    Media
    Janine McCargo
    The Ruth Group
    Tel:  656-536-7033
    Email:  jmccargo@theruthgroup.com
    SINOVAC BIOTECH LTD.

    Consolidated Balance Sheets
    (Unaudited)
    (Expressed in U.S. Dollars)

                                          September 30,           December 31,
                                              2009                    2008

    ASSETS

    Current assets
     Cash and cash equivalents            $46,579,789           $32,894,102
     Accounts receivable - net             36,917,624            19,486,596
     Inventories                           13,541,462             6,486,351
     Income tax refundable                          -               348,018
     Prepaid expenses and deposits            877,260               933,297
     Deferred tax assets                      678,620             1,189,831

    Total current assets                   98,594,755            61,338,195

    Property, plant and equipment          21,426,879            19,262,099
    Long term inventories                   3,110,828               942,514
    Deferred tax asset                        532,854               569,937
    Licenses and permits                      794,567             1,090,477

    Total assets                         $124,459,883           $83,203,222

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Current liabilities
     Loans payable                        $21,937,522            $8,024,277
     Accounts payable and accrued
      liabilities                          14,301,303            11,909,037
     Income tax payable                     2,962,831                     -
     Due to related  parties                   46,971                46,971
     Dividends payable to
      non-controlling shareholder
      of Sinovac Beijing                      115,957               115,677
     Deferred tax liability                   768,876                     -
     Deferred research grants               1,051,099             1,182,703

    Total current liabilities              41,184,559            21,278,665

    Deferred  government grants             2,690,382             2,836,994
    Loan payable                                    -             2,188,439
    Deferred revenue                        9,798,760                     -

    Long-term debt                         12,489,142             5,025,433

    Total liabilities                      53,673,701            26,304,098

    Commitments and contingencies

    STOCKHOLDERS' EQUITY

    Preferred stock                                -                      -
     Authorized 50,000,000 shares
      at par value of $0.001 each
     Issued and outstanding: nil
    Common stock                               42,584                42,894
     Authorized: 100,000,000 shares
      at par value of $0.001 each
     Issued and outstanding:
      42,583,761(2008- 42,893,928 )
    Additional paid in capital             42,299,500            41,629,506
    Accumulated other comprehensive
     income                                 4,218,717             4,143,225
    Dedicated reserves                      5,549,684             5,549,684
    Retained earnings (accumulated
     deficit)                               9,407,160            -1,651,534

    Total stockholders' equity             61,517,645            49,713,775
    Non-controlling interest                9,268,537             7,185,349

    Total equity                           70,786,182            56,899,124

    Total liabilities and equity         $124,459,883           $83,203,222



    SINOVAC BIOTECH LTD.
    Consolidated Statements of Income and Comprehensive Income
    Three Months and Nine Months Ended September 30, 2009 and 2008
    (Unaudited)
    (Expressed in U.S. Dollars)

                                  Three months ended         Nine months ended
                                     September 30              September 30
                                   2009         2008         2009         2008

    Sales                   $21,224,685   $8,753,671  $47,809,111  $34,137,101

    Cost of sales -
     (exclusive of
     depreciation of
     land -use rights and
     amortization of
     licenses and permits
     of $104,732 (2008 -
     $102,742) for three
     months and $314,081
     (2008- $202,575)
     for nine months          3,675,695    1,658,862    8,886,251    5,320,667

    Gross profit             17,548,990    7,094,809   38,922,860   28,816,434

    Selling, general
     and administrative
     expenses                 3,519,977    3,791,916   11,927,879   13,408,452

    Research and
     development
     expenses - net of        1,443,834      811,901    2,753,009    2,408,745
     $133,176 (2008-
     $16,829) for three
     months and $261,861
     (2008- $147,958) for
     nine months in
     government
     research grants

    Depreciation of
     property, plant
     and equipment and
     amortization of
     licenses and
     permits                    179,962      178,404      511,835      526,117

    Total operating
     expenses                 5,143,773    4,782,221   15,192,723   16,343,314

    Operating income         12,405,217    2,312,588   23,730,137   12,473,120

    Interest and
     financing expenses        (246,036)    (189,935)    (571,349)   (747,496)
    Interest income
     and other income
     (expenses)                  77,300       58,456      243,451     (36,685)

    Income  before
     income taxes and
     non-controlling
     interest                12,236,481    2,181,109   23,402,239   11,688,939

    Income taxes
     recovery (expense)
     - Current               (3,230,985)  (1,005,174)  (5,026,902) (4,229,613)
     - Deferred                (551,478)      94,028   (1,399,428)     991,461

    Consolidated net
     income for the
     period                   8,454,018    1,269,963   16,975,909    8,450,787

    Less: net income
     attributable to
     non-controlling
     interest                (3,228,659)    (530,084)  (5,917,215) (2,814,703)

    Net income
     attributable to
     the stockholders        $5,225,359     $739,879  $11,058,694   $5,636,084

    Net income for the
     period                  $8,454,018    1,269,963   16,975,909    8,450,787

    Other comprehensive income
    Foreign currency
     translation
     adjustment                  64,108       33,637       90,728    2,358,956

    Total comprehensive
     income                   8,518,126    1,303,600   17,066,637   10,809,743
    Less: comprehensive
     income attributable
     to non-controlling
     interest                 3,229,599      522,960    5,932,451    2,889,658

    Comprehensive income
     attributable to
     stockholders            $5,288,527     $780,640  $11,134,186   $7,920,085

    Earnings per share
     - basic and
     diluted                      $0.12        $0.02        $0.26        $0.13

    Weighted average
     number of shares of
     common stock
     outstanding
    - Basic                  42,428,755   42,873,511   42,574,921   42,299,187
    - Diluted                43,631,572   43,142,788   42,758,104   42,638,584




    SINOVAC BIOTECH LTD.
    Consolidated Statements of Cash Flows
    Three Months and Nine Months Ended September 30, 2009 and 2008
    (Unaudited)
    (Expressed in U.S. Dollars)

                                    Three Months ended       Nine Months ended
                                        September 30            September 30
                                    2009         2008         2009        2008

    Cash flows from (used in)
      operating activities
     Net Income for the
      period                  $8,454,018   $1,269,963  $16,975,909  $8,450,787
     Adjustments to
      reconcile net
      income to net cash
      used by operating
      activities:
     - deferred income
      taxes                      551,478     (94,028)    1,399,428   (991,461)
     - loss (income) On
       disposal fixed
       assets                        641        2,249      (6,708)       2,249
     - stock-based
       compensation              180,152       16,635      308,195      49,907
     - provision for
       doubtful debts         (1,595,787)     408,289      717,137   1,968,207
     - depreciation
       of property,
       plant and
       equipment, and
       amortization of
       licenses                  529,957      517,751    1,394,064   1,298,314
     - research and
       development
       expenditures
       qualified for
       government grant         (133,176)     (16,829)   (261,861)   (147,677)
     Change in other
      assets and
      liabilities
     - accounts
       receivable             (3,545,198)    4,718,247 (18,088,750)(8,650,832)
     - inventories            (4,063,146)  (1,620,126)  (9,198,785)(3,934,756)
     - income tax
       refundable
       (payable)               3,482,345             -   3,309,317           -
     - prepaid
       expenses and
       deposits                 (197,728)      273,079      58,098     188,789
     - advance from
       stockpiling
       program                   147,160             -   9,791,728           -
      - accounts
       payable and
       accrued
       liabilities             3,646,229   (2,168,844)   2,362,439   1,973,562

    Net cash
     provided by
     operating
     activities                7,456,945     3,306,386   8,760,211     207,089

    Cash flows from
     (used in)
     Financing
     activities
     Loan proceeds                     -   (3,572,010)  16,074,281           -
     Loan repayment           (4,384,356)    2,143,206 (4,384,356) (3,572,010)
     Proceeds from
      issuance of
      common stock               693,285             -     693,285   2,143,206
     Repurchase of
      common shares                    -             -   (335,831)   9,854,560
    Loan repayment
      from non-
      controlling
      shareholder of
      Sinovac Beijing          1,461,298             -           -           -
     Proceeds from
      shares subscribed            4,035        20,060       4,035      20,060
     Dividends paid
      to non-
      controlling
      shareholder of
      Sinovac Beijing         (3,846,501)            - (3,846,501) (2,947,877)
     Government grant
      received                   171,326       143,626     171,326     214,321

    Net cash
     provided by (used
     in) financing
     activities               (5,900,913)   (1,265,118)  8,376,239   5,712,260

    Cash flows from
      (used in) investing
      activities
     Restricted cash                   -       434,196           -       (725)
    Acquisition of
     property, plant
     and equipment            (1,718,443)   (1,046,849) (3,480,444)(3,283,424)

    Net cash used in
     investing
     activities               (1,718,443)     (612,653) (3,480,444)(3,284,149)

    Exchange effect
     on cash and
     equivalents                  37,748       303,614      29,681     845,803

    Increase
     (decrease) in
     cash and cash
     equivalents                (124,663)     1,732,229  13,685,687  3,481,003

    Cash and cash
     equivalents,
     beginning of
     period                   46,704,452    18,820,271  32,894,102  17,071,497

    Cash and cash
     equivalents, end
     of period               $46,579,789   $20,552,500 $46,579,789 $20,552,500

    Cash paid for
     interest, net of
     interest
     capitalized                $285,423      $150,657    $615,691    $456,665

    Cash paid
     (received) for
     income taxes              $(251,359)    $1,502,166  $1,717,585 $2,812,129

SOURCE Sinovac Biotech Co., Ltd.


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SOURCE Sinovac Biotech Co., Ltd.
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