Sinovac Biotech, Ltd. (NASDAQ:SVA)

WEB NEWS

Monday, June 15, 2020

Hot Bio-Tech News

BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. ( “Sinovac” or the “ Company”)(Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles.

The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials. Of those, 143 volunteers are in phase I and 600 volunteers are in phase II. There have been no severe adverse event reported in either the phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce positive immune response.

The Company expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (NMPA) in the near future and commence application of phase III clinical trials outside of China. As previously announced on June 11, 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study. The Company expects to share the full data on our clinical trials with the public through academic publications.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “Our phase I/II study shows CoronaVac is safe and can induce immune response. Concluding our phase I/II clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19. We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19. Like with our other vaccines, we are committed to developing CoronaVac for global use as part of our mission of supplying vaccines to eliminate human diseases.”

As announced previously, Sinovac’s development of a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China. The Company received approval from China’s NMPA on April 13 to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China.

 


Thursday, June 11, 2020

Hot Bio-Tech News

Sinovac Biotech Ltd., ("Sinovac" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, and Instituto Butantan, a leading Brazilian producer of immunobiologic products, today announced the signing of a clinical development collaboration agreement to advance the clinical trials of CoronaVac, Sinovac’s inactivated vaccine candidate against COVID-19 to Phase III.

Sinovac has made significant progress in the development of CoronaVac. Promising preclinical results regarding CoronaVac were recently published in the peer-reviewed academic journal Science in an article stating that the vaccine candidate is safe and provides protection to rhesus macaques (monkeys) through an animal challenge study. Sinovac has received approval from China’s National Medical Products Administration (NMPA) to conduct Phase I/II human clinical trials in China to determine the vaccine candidate’s safety, tolerance, dosage and immunization schedule. In addition, Sinovac is constructing a commercial vaccine production plant in China that is expected to manufacture up to 100 million doses of CoronaVac annually.

Through this collaboration, Instituto Butantan will sponsor Phase III clinical trials in Brazil. This is the first in a series of agreements expected to be completed between the parties to establish extensive collaboration that includes technology licensing, market authorization and commercialization of CoronaVac. In this way, Instituto Butantan can ensure that the Brazilian population has access to this vaccine.

Dr. Dimas Covas, Director of Instituto Butantan commented, "This pandemic is having a tragic impact worldwide and this distinguished alliance with Sinovac to conduct the last phase of the clinical trials will bring hope to have a vaccine in the short term. Butantan expects to support not only on the clinical development, but also commercialization and manufacturing activities of CoronaVac in Brazil."

Dr. Ricardo Palacios, Clinical Research Medical Director of Instituto Butantan added, "Sinovac’s CoronaVac is based on a well-known, reliable technology suited to being incorporated into existing public health immunization programs in Brazil. Current epidemiology in Brazil and the experience of Butantan in clinical development will complement Sinovac’s efforts allowing accelerated progress toward development of a safe and effective immunization against COVID-19."

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are proud to take part in the fight against COVID-19, and we look forward to working with Instituto Butantan to help the people of Brazil. Through this partnership, Sinovac will be able to further the unprecedented speed of developing CoronaVac without compromising our high safety standards and procedures. We also welcome this opportunity to further our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases."


Wednesday, May 6, 2020

Comments & Business Outlook

Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today the publication of the preclinical study on animals for its vaccine candidate against COVID-19. This is the first challenge study of its SARS-CoV-2 vaccine candidate on animals to prove that the vaccine candidate is safe and provides protection to rhesus macaques. The paper, "Rapid development of an inactivated vaccine for SARS-CoV-2," is currently available online at Science magazine’s website at https://science.sciencemag.org/lookup/doi/10.1126/science.abc1932.

"Our study shows that our inactivated vaccine candidate induced SARS-CoV-2-specific neutralizing antibodies in mice, rats, and non-human primates, specifically the rhesus macaque. In fact, the results showed that our vaccine candidate offered safe and complete protection in rhesus macaques against SARS- CoV-2 strains," commented Mr. Weidong Yin, Chairman, President, and CEO of Sinovac.

As announced previously, Sinovac’s work on developing a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China. The Company received approval in April to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China. The Company has commenced the phase I trial on 144 healthy adults aged 18-59 years.

"Our preclinical results suggest a path forward for the clinical development of a SARS-CoV-2 vaccine for use in humans. As we begin our phase I trials, we will also accelerate the progress of our research in order to support the worldwide fight against COVID-19. Sinovac remains committed to developing vaccines for global use," Mr. Yin concluded.

The preclinical paper is jointly authored by researchers from Sinovac, the Institutes of Laboratory Animal Sciences of China Academy of Medical Science, the Center of Disease Control and Prevention of Zhejiang Province, the Institute of Biophysics of Chinese Academy of Sciences, the National Institutes for Food and Drug Control in China, and the National Institute for Communicable Disease Control and Prevention of the Chinese Center for Disease Control and Prevention.


Friday, April 17, 2020

Hot Bio-Tech News

BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the Company has commenced Phase I clinical trial, a randomized, double-blinded, placebo controlled study, for its vaccine candidate against COVID-19. Enrollment of the first group of volunteers and the first dose of vaccination for these volunteers have been completed.

This study is to evaluate the safety, tolerance, and preliminary immunogenicity of the Company’s SARS-CoV-2 vaccine by vaccinating 144 healthy adults, aged from 18 to 59, with two different dosages of the vaccine candidate. Two-thirds of the volunteers will be vaccinated with the investigational vaccine while one-third of volunteers will be administered with the placebo. The trial is being conducted in Jiangsu Province.

On April 13, 2020, the randomized, double-blinded, placebo-controlled phase I/II clinical trials of the inactivated SARS-CoV-2 vaccine developed by Sinovac was approved by China’s National Medical Products Administration (NMPA) to evaluate the vaccine candidate’s safety and immunogenicity.

Mr. Weidong Yin, Chairman, President and CEO said, “The vaccine is critical to the eventual prevention of the spread of COVID-19. Commencing our human trial is another milestone achieved by our scientists together with our vaccine development partners. Sinovac will accelerate the progress of our research in order to support the worldwide fight against COVID-19.”


Tuesday, April 14, 2020

Hot Bio-Tech News

BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to conduct a human clinical trial on an inactivated SARS-CoV-2 (commonly referred to as COVID-19) vaccine candidate.

The vaccine development commenced at the end of January 2020. Sinovac scientists have raced to complete comprehensive preclinical studies in partnership with leading academic research institutes in China. As part of this work, an animal challenge study has shown that the vaccine candidate protects animals without antibody-dependent enhancement (or ADE). In addition, the vaccine candidate can neutralize virus strains from different countries, which supports the potential of using the vaccine to prevent the spread of the disease globally.

Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “At present, the whole world is facing an unprecedented public health crisis. It is a matter of urgency to develop an effective vaccine to control the spread of COVID-19 globally, as quickly as possible. Sinovac has been working closely with the regulators in China in order to make this happen. Sinovac has always been committed to developing vaccines for global use when facing pandemics.”

Meanwhile, due to measures put in place to stop the spread of COVID-19, the Company’s daily operations have been impacted. Domestic sales have ceased due to the suspension of vaccinations by the Chinese CDC since February, and exports are disrupted due to cancellations of cargo flights and inflated freight costs. Any prolonged disruption of Sinovac’s clinical trials, suppliers, or contract manufacturers could delay regulatory approvals or the commercialization of any current or future products. Certain provinces and cities in China are starting to lift some of the restrictive measures, and delivery of vaccines in China has slowly started to resume. The Company is closely monitoring the situation in China as well as in the other countries in which it markets its vaccines.


Tuesday, April 30, 2019

Comments & Business Outlook

BEIJING--(BUSINESS WIRE)--

Sinovac Biotech Ltd. (SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, has filed its 2018 annual report on Form 20-F with the U.S. Securities and Exchange Commission for the year ended December 31, 2018. The Company also reported its unaudited financial results for the second half of the year ended December 31, 2018.

Second Half of 2018 Financial Highlights

  • Sales for the second half of 2018 were $107.2 million, which remains the same compared to $107.4 million in the prior year period. Revenue generated by Hepatitis A vaccine increased by $12.0 million compared to same period in 2017, which was offset by $13.6 million decrease in the Company’s influenza vaccine. In second half of 2018, nil revenue generated by the Company’s influenza vaccine in the flu season 2018-2019 caused by the suspension of influenza vaccine production and destruction of inventory in April 2018 as a result of the disruptive actions of the minority shareholder of our subsidiary, Sinovac Biotech Co., Ltd.
  • Net income attributable to common shareholders was $7.7 million, or $0.11 per basic and diluted share, compared to net income attributable to common shareholders of $15.0 million, or $0.26 per basic and diluted share, in the prior year period.

Monday, February 25, 2019

Comments & Business Outlook

BEIJING--(BUSINESS WIRE)--

Sinovac Board of Directors Determines Certain Collaborating Shareholders Became Acquiring Persons, Voiding their Preferred Share Purchase Rights;
Valid Preferred Share Purchase Rights Held by all Non-Collaborating Shareholders Exchanged for Common and Preferred Shares;
Board of Directors Amends and Restates Rights Agreement and Declares Dividend Distribution of New Preferred Share Purchase Rights.
Sinovac Biotech Ltd. (SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that its Board of Directors (the “Board”) determined that certain stockholders became “Acquiring Persons,” as defined in the Company’s Rights Agreement (“Rights Agreement”), prior to the Company’s Annual General Meeting held on February 6, 2018 (the “AGM”). As a result, a “Trigger Event” occurred under the Rights Agreement. The Board effectuated the exchange (the “Exchange”) of each preferred share purchase right (the “Rights”) that was valid and outstanding as of the close of trading in the United States on February 22, 2019 for 0.655 of the Company’s common shares (the “Common Shares”) and .345 of the Company’s newly created Series B Convertible Preferred Shares (the “Series B Preferred Shares” and, together, each an “Exchange Share”). The total Exchange Shares to be received by any holder will be rounded up to the nearest whole Common Share and rounded down to the nearest whole Series B Preferred Share. Since the Company is issuing a significant number of new Common Shares and Series B Preferred Shares in the Exchange, shareholders should expect the share price to adjust downwards to reflect the issuance of the Exchange Shares. The Board also amended and restated the Rights Agreement and declared a dividend of one preferred share purchase right (the “New Rights”) for each share of the Company’s capital stock outstanding as of the close of business on February 22, 2019.

Overview

As previously disclosed by the Company on December 19, 2018, the High Court of Justice of Antigua and Barbuda held that the Company’s Rights Agreement is valid under Antigua law and found that “there was a secret plan to take control of the Company” at the AGM.
Based upon the Court’s judgment and other facts, the Board determined that 1Globe Capital, LLC, Chiangjia Li, OrbiMed Advisors LLC and those additional shareholders who voted together with the foregoing at the AGM, together with their affiliates and associates (collectively, the “Collaborating Shareholders”) became Acquiring Persons on or prior to the AGM and their conduct resulted in a Trigger Event under the Rights Agreement.
Under the Rights Agreement, a Trigger Event occurs when any group of shareholders who beneficially own 15% or more of the Company’s securities have an agreement, arrangement or understanding to act together for the purpose of acquiring, holding, voting or disposing of any securities of the Company.
As a result of becoming Acquiring Persons, the approximately 28.7 million Rights of the Collaborating Shareholders automatically became void under the terms of the Rights Agreement.
Pursuant to the Rights Agreement, the Board elected to exchange the approximately 42.4 million Rights held by the Company’s shareholders other than the Collaborating Shareholders for a combination of approximately 27.8 million Common Shares and approximately 14.6 million Series B Preferred Shares, all of which Sinovac issued today into a trust for the benefit of the holders of the valid and outstanding Rights. The Exchange Shares will not be released from the trust earlier than March 8, 2019.
As a result of this issuance, the aggregate number of outstanding Common Shares increased from approximately 71.1 million to approximately 98.9 million. The approximately 14.6 million newly issued Series B Preferred Shares share equally in all dividends and distributions of the Company and vote together with the Common Shares on all matters brought before the shareholders, in each case on an as-converted basis and subject to applicable law. In addition, until the Series B Preferred Shares are converted into Common Shares (or until the Series B Preferred Shares are listed on a nationally recognized securities exchange), they will earn a preferred dividend equal to $0.41 per annum, payable quarterly in arrears.
The Board also amended the Rights Agreement to extend the expiration date of the Rights Agreement to February 22, 2020 and to declare a dividend of one New Right for each share of the Company’s capital stock outstanding as of the close of business on February 22, 2019. One New Right will also be delivered with each share newly issued following this date.
In order to receive the Exchange Shares in the Exchange, holders of eligible Rights must follow the instructions set forth under “Process for Completing Exchange of Rights” below.
Exchange of Rights for Common and Series B Preferred Shares

On December 19, 2018, the High Court of Justice of Antigua and Barbuda held that the Company’s Rights Agreement is valid under Antigua law, and found that “there was a secret plan to take control of the Company” at the AGM. The Antigua High Court decision, dated December 19, 2018, which has been appealed by 1Globe Capital, LLC, is publicly available as part of claim ANUHCV 2018/0120 in the Eastern Caribbean Supreme Court in the High Court of Justice of Antigua and Barbuda and is available on the Company’s website (http://www.sinovac.com/file/20181219.Judgment.pdf).

On February 18, 2019, after reviewing the Court’s judgment and considering all additional facts known to the Board, the Board determined that the Collaborating Shareholders became Acquiring Persons on or prior to the AGM and that their conduct resulted in a Trigger Event. As a result, Rights held by the Collaborating Shareholders are void and thus ineligible for exchange.

Pursuant to the Rights Agreement, the Board implemented the Exchange. As a result, each holder of eligible Rights will have the right to receive one Exchange Share in exchange for each Right. The total Exchange Shares to be received by any holder will be rounded up to the nearest whole Common Share and rounded down to the nearest whole Series B Preferred Share. As of the close of trading in the United States on February 22, 2019, the Rights converted into the right to receive the Exchange Shares and will no longer trade with the Common Shares, and will not otherwise trade on any securities market.

In order to facilitate the Exchange, today the Company issued 27,777,341 Common Shares and 14,630,813 Series B Preferred Shares into a trust for the benefit of the holders of the valid Rights. In order to receive the Exchange Shares, holders of valid Rights must follow the instructions set forth under “Process for Completing Exchange of Rights” below. The trust agreement provides that shares cannot be released from the trust prior to March 8, 2019.

The Series B Preferred Shares issued today share equally in all dividends and distributions made on the Common Shares and vote together with the Common Shares on all matters brought before the shareholders, in each case on an as-converted basis and subject to applicable law. The Series B Preferred Shares are convertible into Common Shares at the option of the Company, or automatically upon a successful shareholder vote to increase the authorized number of Common Shares of the Company. The Company intends to seek authorization to increase the authorized number of Common Shares of the Company at the next annual general meeting. Until the Series B Preferred Shares are converted into Common Shares (or until the Series B Preferred Shares are listed on a nationally recognized securities exchange), they will earn a preferred dividend equal to $0.41 per annum, payable quarterly in arrears.

Immediately prior to the Exchange, 71,140,902 Common Shares were outstanding, and no Series B Preferred Shares were outstanding. The Company now has 98,918,243 Common Shares and 14,630,813 Series B Preferred Shares outstanding. Since the Company is issuing a significant number of new Common Shares and Series B Preferred Shares in the Exchange, shareholders should expect the share price to adjust downwards to reflect the issuance of the Exchange Shares.

In connection with the Exchange, The Nasdaq Stock Market LLC (“Nasdaq”) has advised the Company that it expects to implement a halt in trading in the Common Shares until at least March 8, 2019 in order to facilitate the orderly distribution of the Exchange Shares. The Company will work with Nasdaq to resume trading of the Common Shares as expeditiously as possible after such date, but is unable to currently estimate when trading will resume.

Adoption of Amended and Restated Rights Agreement and Distribution of New Rights

Also on February 22, 2019, the Board adopted an Amended and Restated Rights Agreement (as amended, the “A&R Rights Agreement”) to protect the best interests of all the Company’s shareholders. The A&R Rights Agreement is designed to ensure that all of the Company’s shareholders receive fair and equal treatment in the event of any proposed takeover of the Company and to guard against partial tender offers, open market accumulations and other abusive or coercive tactics to gain control of the Company without paying all shareholders a control premium. The A&R Rights Agreement is not intended to prevent or interfere with any actions with respect to the Company (including an acquisition of the Company) that the Board determines is in the best interests of all of the Company’s shareholders.

Under the A&R Rights Agreement, which was adopted following evaluation and consultation with the Company’s outside financial and legal advisors, one New Right will be distributed for each Common Share and Series B Preferred Share outstanding as of the close of business on February 22, 2019. The Company is taking the position that the adoption of the A&R Rights Agreement is not a taxable event for shareholders for U.S. federal income tax purposes. The New Rights will have substantially similar rights to the Rights being exchanged under the Rights Agreement and will, under certain circumstances, entitle shareholders to purchase one one-thousandth (subject to adjustment) of a share of the Company’s newly created Series C Junior Participating Preferred Shares at an exercise price of $20.00. The Board will be entitled to redeem the New Rights at $0.01 per right at any time before a person or group has acquired 15% or more of the outstanding share capital of the Company. The New Rights will expire on February 22, 2020, subject to the Company’s right to extend such date, unless earlier redeemed or exchanged by the Company or terminated.

Subject to limited exceptions, if a person or group acquires 15% or more of the share capital of the Company or announces a tender offer and the consummation of that offer would result in such ownership (we refer to such a person or group as an “acquiring person”), each New Right will entitle its holder to purchase, at the right’s then-current exercise price, a number of Common Shares having a market value at that time of twice the right’s exercise price. New Rights held by the acquiring person will become void and will not be exercisable. If the Company is acquired in a merger or other business combination transaction that has not been approved by the Board after the rights become exercisable, each New Right will entitle its holder to purchase, at the right’s then-current exercise price, a number of shares of the acquiring Company’s common stock having a market value at that time of twice the right’s exercise price.

Further details about the Amended and Restated Rights Agreement will be contained in a Form 6-K to be filed by the Company with the U.S. Securities and Exchange Commission.

Latham & Watkins LLP, Morris Nichols Arsht & Tunnell and Dentons Delany serve as legal advisors to the Company.

Process for Completing Exchange of Rights

If you held Common Shares as of the close of trading in the United States on February 22, 2019, you will receive a letter describing the Exchange and the procedures the non-Collaborating Shareholders must follow in order to receive the Exchange Shares in exchange for their Rights. The exchange procedures are designed to ensure that Exchange Shares are not transferred to Acquiring Persons.

Today, the Exchange Shares were issued into the Shareholder 2019 Rights Exchange Trust in the name of Wilmington Trust, National Association (the “Trustee”), which holds the Exchange Shares for the benefit of the Company’s shareholders entitled to receive such Exchange Shares in exchange for the Rights. Upon completion of the verification procedures described below, the Trustee will direct Pacific Stock Transfer Company (the “Transfer Agent”) to exchange the applicable Rights for the appropriate number of Exchange Shares. Pursuant to the trust agreement between the Company and the Trustee, no shares will be released from the trust prior to March 8, 2019.

Sinovac will use different verification procedures for shareholders who hold their Common Shares in “street name” through a bank, broker or other nominee and for shareholders that own shares in their own name on the books and records of the Company. Common Shares held in record name are registered directly in a shareholder’s name with the Transfer Agent.

Procedures for shareholders who hold their shares in “street name” through a bank, broker or other nominee:

You will receive a letter and certification form from your bank, broker or other nominee in the coming days, which will contain additional information regarding the Exchange and will outline the precise procedures you must follow in order to certify your status as a non-Acquiring Person in order to receive the Exchange Shares to which you are entitled.
You will be required to complete the certification form and return it to your bank, broker or other nominee.
Your bank, broker or other nominee will aggregate the certifications received from the Company’s shareholders and will submit a master certification to the Trustee with respect to such shareholders.
Once a master certification is received by the Trustee from a bank, broker or other nominee, the Company will review such certification and, upon completion of such review, direct the Trustee to direct the Transfer Agent to distribute the appropriate number of Exchange Shares out of the Trust and into the certifying bank, broker or other nominee’s account, who will then credit the beneficial owner’s account with the appropriate number of Exchange Shares.
Procedures for shareholders who hold their shares as shareholders of record:

You will receive a letter and certification form in the coming days, which will contain additional information regarding the Exchange and will outline the precise procedures you must follow in order to certify your status as a non-Acquiring Person in order to receive the Exchange Shares to which you are entitled.
You will be required to complete the certification form and return it to the Trustee.
Once your certification form is received by the Trustee, the Company will review such certification and, upon completion of such review, will direct the Trustee to direct the Transfer Agent to credit the appropriate number of Exchange Shares to your account on the books and records of the Company.


Thursday, November 29, 2018

Legal Insights

BEIJING--(BUSINESS WIRE)--

Permanent Injunction Restrains Mr. Li and Mr. Cao from Purporting to Act as or Take Any Actions as Directors of Sinovac HK or its subsidiaries

Senior management of Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company") and the lawful directors of Sinovac Hong Kong, Mr. Yin Weidong and Ms. Wang Nan (“Lawful Directors”), have been granted declaratory orders and permanent injunctive relief against Mr. Li Pengfei (“Mr. Li”) and Mr. Cao Jianzeng (“Mr. Cao”) by the High Court of the Hong Kong Special Administrative Region (“Hong Kong High Court”). Mr. Li and Mr. Cao have appealed the decision to the Court of Appeals.

As described in a press release issued by the Company on October 22, Sinovac Biotech (Hong Kong) Limited (“Sinovac HK”) was granted an interim injunction on October 19, 2018 in the Hong Kong High Court proceedings brought by the Lawful Directors to nullify and remove forged documents that were illegally filed with the Hong Kong Companies Registry (“Companies Registry”), the Hong Kong government body responsible for maintaining official company records. These forged documents were also used in an attempt to unlawfully remove the Lawful Directors of Sinovac HK’s subsidiary, Sinovac Biotech Co., Ltd. (“Sinovac Beijing”) and to deceive the Industry and Commerce Bureau of Beijing into believing that the board of Sinovac Beijing had been reconstituted.

On November 28, 2018 at a further hearing in the Hong Kong High Court, the Hong Kong High Court held that it is beyond dispute that the documents in respect of Sinovac HK had been forged and unlawfully filed with the Hong Kong Companies Registry, based on the evidence filed by Mr. Cao, Mr. Li and the Lawful Directors. The Hong Kong High Court therefore declared that Mr. Yin Weidong and Ms. Wang Nan were and still are the lawful directors of Sinovac HK, and Mr. Li and Mr. Cao were not and are not the lawful directors of Sinovac HK.

The Hong Kong High Court also granted a permanent injunction restraining Mr. Li and Mr. Cao from purporting to act or holding themselves out as directors of Sinovac HK or its subsidiaries (including but not limited to Sinovac Beijing), purporting to take any actions as directors of Sinovac HK or its subsidiaries, and relying on or using the forged documents in any way whatsoever.

Furthermore, the Hong Kong High Court also ordered the Companies Registry to remove the forged documents in respect of Sinovac HK that had been unlawfully filed. The Companies Registry had indicated prior to the November 28, 2018 hearing that it did not oppose the application made by the Lawful Directors and agreed to the terms of the draft Order sought by the Lawful Directors.

The Board of Directors and management of Sinovac are vigorously protecting the rights of all shareholders in all applicable courts. Sinovac has also petitioned in the High Court of Justice in Antigua and Barbuda for 1Globe Capital LLC (“1Globe”) to be restrained from making any attempt to take control of the Company or in any way undermine the court’s authority in the existing litigation between 1Globe and the Company.


Thursday, November 8, 2018

Comments & Business Outlook

BEIJING, Nov. 8, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today its unaudited financial results for the six months ended June 30, 2018.

Financial highlights

Sales revenue for the first six months of 2018 was $122.5 million, compared to $66.9 million in the prior year period, an increase of 83.1%. Sales increased primarily due to revenue generated by the Company's EV71 vaccine.
Net income attributable to shareholders was $14.1 million, or $0.24 per basic and diluted share, compared to net income attributable to shareholders of $10.9 million, or $0.19 per basic and diluted share, in the prior year period.
Business Highlights

Sales and Marketing

In the first half of 2018, sales were mainly generated from the EV71 vaccine. The increase of EV71 vaccine sales was primarily attributable to government advocacy regarding the benefits of this vaccine to the public. In March 2018, the National Health Commission of the People's Republic of China ("NHFPC") issued a notice to encourage vaccination to prevent hand, foot and mouth disease due to the expected high prevalence of this disease in 2018. In addition, since late 2017, Sinovac has been collaborating with third party companies to improve market coverage and penetration in the private sector of the Chinese market. As a result, the number of customers increased over 30% in the first half of 2018 compared to the same period in 2017. Also in the first half of 2018, the marketing team of Sinovac expanded its activities, including academic promotion activities at the national, provincial, district, and county levels, which largely improved the awareness of Sinovac's EV71 vaccine among professionals and consumers.

The Company does not expect any sales of seasonal influenza vaccine during the 2018-2019 flu season. As was announced in April 2018, production at the Company's hepatitis A vaccine and flu vaccine bulk production site was suspended when a minority shareholder of Sinovac Beijing forcibly entered Sinovac Beijing's corporate offices along with dozens of unnamed individuals in an attempt to wrongfully take control of Sinovac Beijing's operations. As it was determined that the quality and safety of the vaccines could not be sufficiently verified to the Company's high standards following the disruption, the vaccines in production at the time of the attack were destroyed. Since the attacks, the Company has verified the safety and quality of the vaccine production process, and is ready to resume production in anticipation of next year's market demand. Sales of flu vaccine for the 2017-2018 flu season were $13.5 million.


Wednesday, October 17, 2018

Legal Insights

BEIJING, Oct. 17, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ:  SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the United States District Court of the District of Massachusetts denied 1Globe Capital LLC's ("1Globe") August 2018 motion for a preliminary injunction seeking to enjoin Sinovac from issuing shares of Company stock to the PIPE investors or any other individuals pending the outcome of the ongoing litigation between the parties in the High Court of Justice in Antigua and Barbuda. As previously announced by the Company in July 2018, the Company completed the PIPE transaction and issued shares to the PIPE investors. The proceeds from the PIPE transaction enable the company to increase its capabilities in quality research and to build additional production facilities to support the development and commercialization of sIPV-based combination vaccine and other new vaccine projects.

The Court found, among other things, that 1Globe failed to demonstrate that it has a reasonable likelihood of success on the merits of its direct and derivative federal securities law claims challenging the PIPE transaction because it lacked standing to bring those claims, and that 1Globe failed to demonstrate that it will suffer irreparable harm if the injunction was not granted.

Sinovac welcomes the Court's decision to deny the preliminary injunction requested by 1Globe. The board of directors and management of Sinovac continue to execute their fiduciary duties to act in the best interests of the Company and all shareholders as the Company moves forward in its mission to develop vaccines that enhance health in China and around the world and create shareholder value.


Monday, September 17, 2018

Resolution of Legal Issues

BEIJING, Sept. 17, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the U.S. Department of Justice ("DOJ") has closed its investigation, with no charges, into possible violations of the Foreign Corrupt Practices Act related to allegations that certain Sinovac employees made improper payments to Chinese government officials. The closing of the DOJ investigation follows the SEC's termination of its related investigation, which the Company announced on August 20, 2018.  With the closure of the DOJ's investigation, the Company is not aware of any pending U.S. government investigations of the Company related to these matters. Sinovac is committed to conducting business in compliance with all applicable laws and cooperated fully with the DOJ. Sinovac will continue in its mission of researching, developing, manufacturing and commercializing vaccines that protect against human infectious diseases.


Monday, August 20, 2018

Legal Insights

BEIJING, Aug. 20, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the U.S. Securities and Exchange Commission ("SEC") has concluded its investigation into possible violations of the federal securities laws related to allegations that certain Sinovac employees made improper payments to Chinese government officials. The SEC determined that it will not recommend or pursue an enforcement action against Sinovac at this time. Sinovac is committed to conducting business in compliance with all applicable laws and cooperated fully with the SEC. Sinovac will continue in its mission of researching, developing, manufacturing and commercializing vaccines that protect against human infectious diseases.


Monday, June 11, 2018

Comments & Business Outlook

BEIJING, June 11, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the company has relaunched its website, at www.sinovacbio.com.

On April 30, 2018, the Company temporarily blocked access to its websites upon discovering that Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing, inappropriately and without authorization seized control of the Company's websites.

The relaunched website will allow all regulators, shareholders, customers, employees, and other interested stakeholders to access relevant materials, as the Company moves forward in its mission to develop vaccines that enhance health in China and around the world and create shareholder value.


Tuesday, May 8, 2018

Comments & Business Outlook

BEIJING, May 8, 2018 /PRNewswire/ --  Sinovac Biotech Ltd. (SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today announced it has been forced to suspend production at its plant for hepatitis A vaccine, and to destroy the bulk of its hepatitis A vaccines being produced at its Shangdi site, which is capable of producing approximately 3.5 million doses of finished product hepatitis A vaccines. The Company is not presently able to assess the impact on its sales of hepatitis A vaccine due to a lack of certainty regarding both the market's reaction to this incident, as well as the schedule for resuming production.

Sinovac made this decision due to actions taken by Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing.

Following the multiple disruptions of the Company's power source by Sinobioway, Sinovac Beijing initiated its emergency response protocol and resumed production and quality management activities step by step. After hepatitis A vaccine production resumed on April 23, 2018, the quality assurance department performed several assessments of the production environment and vaccine safety. Unfortunately, it was determined that the quality and safety of the vaccines could not be sufficiently verified to the Company's high standards. Given the fact that Sinobioway continues to disrupt operations at Sinovac Beijing, the Company has decided again to temporarily suspend the hepatitis A vaccine production plant and the production of bulk of hepatitis A vaccine. The Company will inspect the affected plant, fumigate and sterilize the facilities, and verify whether any equipment was damaged by the power outage in April.

On May 6, 2018 a group of approximately 20 people wearing security uniforms surrounded Sinovac Beijing's office, and threatened and intimidated the Company's employees. In the altercation, one of our employees was pushed to the ground and injured by a security guard working for Sinobioway. The Sinobioway security guard was detained by police for questioning, while the Sinovac Beijing employee was treated and discharged from the emergency center of the Red Cross.

Mr. Pan and others have taken a number of aggressive actions that continue to harm the Company's shareholders and customers. These actions include intentionally interfering with the audit of the Company's financials, forcibly taking control of Sinovac Beijing's corporate offices and the Shangdi site, limiting the physical movement of the employees in Sinovac Beijing's general manager's office and finance department, cutting the power to the Shangdi site, disrupting Sinovac Beijing's hepatitis A and seasonal flu vaccine production, and forcing the Company to destroy vaccines.


Tuesday, May 1, 2018

Comments & Business Outlook

BEIJING, May 1, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today announced it has been forced to temporarily suspend its flu vaccine production and destroy the flu vaccines it is currently producing. The Company expects this will result in its inability to supply flu vaccines for the 2018 to 2019 flu season. These decisions have been made necessary by the actions taken by Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed Chairman by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing.

As previously announced, on April 17, 2018, Mr. Pan and dozens of unnamed individuals forcibly entered Sinovac Beijing's corporate offices in Shangdi site and limited the physical movement of the employees in Sinovac Beijing's general manager's office and finance department. This was in an attempt to take control of Sinovac Beijing's official seal, legal documents, accounting seal, financial documents and financial information systems. In attempting to forcibly take control of the Company's corporate offices, these individuals cut power to the facility in Shangdi site, thereby disrupting Sinovac Beijing's hepatitis A and seasonal flu vaccine production, seriously impacting Sinovac Beijing's production and manufacturing processes and very possibly damaging product quality.

Sinovac Beijing initiated its emergency response protocol and resumed production and quality management activities step-by-step. Once flu vaccine production was resumed, the quality assurance department performed several assessments of the production environment and vaccine safety. Unfortunately, it was determined that the quality and safety risks associated with salvaging these vaccines were not able to be completely eliminated. The Company is assessing the risk associated with other vaccine production at Shangdi site in parallel.

BEIJING, April 30, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing, inappropriately and without authorization seized control of the Company's websites, www.sinovac.com and www.sinovac.com.cn.  Out of an abundance of caution, the Company has temporarily blocked the access to the websites to avoid any further unauthorized access or tampering that could mislead any interested stakeholders.

The misappropriation of the Company's websites is another blatant attempt by Mr. Pan and Sinobioway to interfere with Sinovac's business.

The Company advises all regulators, shareholders, customers, employees, and other interested stakeholders that authorized English messages from the Company will be distributed via the Company's PR Newswire account and filings with the U.S. Securities and Exchange Commission and authorized Chinese messages from the Company will be distributed via the Company's official WeChat public account (account name: SinovacBiotech) until the Company regains control of its websites.


Monday, April 30, 2018

Comments & Business Outlook

BEIJING, April 30, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced it has been forced to destroy the bacterial seeds intended for use in the production of its 23-valent pneumococcal polysaccharide vaccine, or PPV, and to suspend all preparations for and ultimately postpone the China Food and Drug Administration (CFDA) inspection of the manufacturing site necessary for 23-valent PPV production approval. These decisions have been made necessary by the actions taken by Aihua Pan, the Chairman of the Board of the Company's controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), who was appointed by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing.

As previously announced, on April 17, 2018, Mr. Pan and dozens of unnamed individuals forcibly entered Sinovac Beijing's corporate offices and limited the physical movement of the employees in Sinovac Beijing's general manager's office and finance department. This was in an attempt to take control of Sinovac Beijing's official seal, legal documents, accounting seal, financial documents and financial information systems. One of the Company's buildings has been occupied by these individuals since this date, and Sinovac Beijing employees are still not permitted to enter.

Portions of the 23-valent PPV manufacturing facility, as well as one of the refrigerators where the bacterial seeds are stored, is located in the occupied building. In accordance with the Company's internal quality management regulations, employees are required to inspect and record the temperature of the refrigerator twice daily. With Sinovac Beijing employees unable to enter the facilities and perform these quality checks, the Company has no assurances as to the quality of bacterial seeds and other key materials stored in this building for use in the production of the 23-valent PPV. As a result, Sinovac Beijing has been left with no choice but to plan to destroy the bacterial seeds and suspend preparations for the CFDA site inspection required for production approval. The Company expects this will delay the commercialization of its 23-valent PPV.

Sinovac Beijing's 23-valent PPV is designed to prevent streptococcus pneumoniae (pneumococcus) infections in people over two years old. The vaccine development was initiated in 2008 and was approved for human clinical trial in 2014. The clinical studies were completed in 2017 and the production license application was submitted to the CFDA in June 2017.


Friday, April 27, 2018

Going Private News

BEIJING, April 27, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (SVA), a leading provider of biopharmaceutical products in China, today announced that on April 26, 2018, it entered into Amendment No. 2 to the Amalgamation Agreement (the "Amendment") to further amend the Amalgamation Agreement, dated as of June 26, 2017 (as amended by Amendment No. 1 to the Amalgamation Agreement, dated as of March 26, 2018, the "Amalgamation Agreement"), among the Company, Sinovac (Cayman) Limited ("Parent") and Sinovac Amalgamation Sub Limited ("Amalgamation Sub"), a wholly-owned subsidiary of Parent.

Under the terms of the Amalgamation Agreement, the Amalgamation Agreement may be terminated by the Company or Parent if the amalgamation of Amalgamation Sub with and into the Company (the "Amalgamation") has not occurred on or before April 26, 2018 (the "Termination Date"). The Amendment extends the Termination Date to May 26, 2018.


Friday, April 27, 2018

Investor Alert

BEIJING, April 27, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that it will delay the filing of its annual report on Form 20-F for the year 2017 (the "2017 Annual Report"). The delay is the result of actions taken by Aihua Pan, the Chairman of the Board of the Company's 73.09% controlled China subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"). Mr. Pan was appointed Chairman of the Board by Sinobioway Biomedicine Co., Ltd. ("Sinobioway"), the minority shareholder of Sinovac Beijing.

As previously announced, on April 17, 2018, Aihua Pan and dozens of unnamed individuals forcibly entered Sinovac Beijing's corporate offices and limited the physical movement of the employees in Sinovac Beijing's general manager's office and finance department. This was in an attempt to take control of Sinovac Beijing's official seal, legal documents, accounting seal, financial documents and financial information systems. One of our buildings where the finance department is located is occupied and employees of Sinovac Beijing are not permitted to enter.

The occupation of the finance department of Sinovac Beijing has caused disruption to the Company's 2017 annual audit, which will delay the filing of the Company's 2017 Annual Report. The Company will file the Notification of Late Filing on Form 12b-25 with the Securities and Exchange Commission to provide the formal notification of the delay. The Company is working diligently with its auditor to file the 2017 Annual Report as soon as practicable.


Tuesday, April 24, 2018

Comments & Business Outlook

BEIJING, April 23, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today announced that hepatitis A vaccine and seasonal flu vaccine production has resumed at the Shangdi manufacturing facility of its controlled Chinese subsidiary, Sinovac Biotech Co., Ltd. ("Sinovac Beijing"). Production, R&D and quality assurance resumed under regulatory supervision, ensuring that the Company can satisfy the medical needs of Chinese and international organizations with vaccines that are vital to people's lives and the national economy.

The successful resumption of regular production and operations at Sinovac Beijing's Shangdi manufacturing facility follows the events of April 17, 2018, when Aihua Pan, the Chairman of the Board of Sinovac Beijing appointed by Sinobioway, forcibly entered Sinovac Beijing's corporate offices along with dozens of unnamed individuals in an attempt to wrongfully take control of Sinovac Beijing's operations.

These wrongful actions taken by Sinobioway, which involved cutting power to Sinovac Beijing facilities on multiple occasions and physically preventing Sinovac Beijing employees from working production lines, seriously disrupted vaccine production. In response, Sinovac Beijing initiated its emergency response protocol, which involved suspending production, discarding the impacted vaccines in production, taking concrete measures to prevent risks associated with biosafety, and reporting the disruption to regulators and partners in a timely manner.

After careful evaluation, the production and quality assurance systems of Healive, a hepatitis A vaccine, Anflu, a seasonal flu vaccine, and Inlive resumed and are operating normally. The production of Inlive, an EV71 vaccine, located at Sinovac Beijing's Changping site was not affected by the illegal intrusion. The Company's supply of raw materials was also unaffected.

Sinovac Beijing is conducting its quality control protocols, including testing raw materials, water for injection, and product samples during different production processes.

As always, Sinovac strictly follows Good Manufacturing Practices ("GMP") guidelines to ensure its vaccine safety and effectiveness. Sinovac believes that its emphasis on product quality is an advantage and increases its competitiveness.


Friday, April 20, 2018

Comments & Business Outlook

BEIJING, April 19, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today announced preliminary results of a phase III clinical study on Sabin inactivated polio vaccine ("sIPV") developed by Sinovac Biotech Co., Ltd. ("Sinovac Beijing") on the unblinding conference held on April 19, 2018.

The preliminary results of the trial after unblinding show the seroconversion rate of poliovirus type II is superior to the control vaccine and seroconversion rates of the other two types of poliovirus are non-inferior to the control vaccine. And geometric mean titer ("GMT") of three poliovirus types are all higher than the control vaccine. The Company will prepare the production license application after the clinical report is finalized.

The phase III trial is a randomized, double-blind, controlled clinical trial to evaluate the immunogenicity and safety of sIPV in 2-month-old infants. The trial commenced in August 2017 with twelve hundred healthy volunteer subjects enrolled in the study. The primary vaccination schedule sets three doses with a one month interval between doses and the trial was carried out in Jiangsu province, China.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The promising results from the phase III clinical trial are an important milestone we achieved towards providing vaccines to eliminate human disease related to polio. The Company will commercialize this vaccine in the China market as well as the markets in which the United Nations ("UN") operates under the WHO's Polio Eradication & Endgame Strategic Plan. The vaccine will also contribute to the diversification of our pipeline product portfolio by providing us with the opportunity to develop a sIPV related combo vaccine in the future."

As previously announced, Sinovac has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from Netherlands to develop and commercialize sIPV for distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV. The Company obtained the clinical license of sIPV in December 2015. The phase I and phase II trials were completed in 2017.


Tuesday, March 27, 2018

Going Private News

BEIJING, March 27, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (SVA), a leading provider of biopharmaceutical products in China, today announced that on March 26, 2018, it entered into Amendment No. 1 to the Amalgamation Agreement (the "Amendment") to amend the Amalgamation Agreement, dated as of June 26, 2017 (the "Amalgamation Agreement"), among the Company, Sinovac (Cayman) Limited ("Parent") and Sinovac Amalgamation Sub Limited ("Amalgamation Sub"), a wholly-owned subsidiary of Parent.

Under the terms of the Amalgamation Agreement, the Amalgamation Agreement may be terminated by the Company or Parent if the amalgamation of Amalgamation Sub with and into the Company (the "Amalgamation") has not occurred on or before March 26, 2018 (the "Termination Date"). The Amendment extends the Termination Date to April 26, 2018.


Thursday, March 15, 2018

Comments & Business Outlook

BEIJING, March 15, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today responded to public statements made by other parties falsely claiming to control the Company, including a press release falsely purporting to come from Sinovac itself. These statements have misrepresented the outcome of the Company's recent annual general meeting (AGM) and the composition of the Sinovac board and have attempted to confuse and undermine the Company's legitimate leadership.

The Company emphasized that third parties, including the dissident shareholders who sought to disrupt the election of directors at the AGM  do not have the authority to determine or announce the results of Sinovac's AGM, comment on the Company's governance or speak on behalf of the Company.

As Sinovac has previously stated, all five of the Company's incumbent directors - Weidong Yin, Yuk Lam Lo, Simon Anderson, Kenneth Lee and Meng Mei - were properly re-elected at the AGM by a majority of the votes validly cast. The Board takes seriously its duty to protect the value of the Company for all shareholders, and has taken actions to ensure the continued stable operation of the business, including the appointment by Sinovac Biotech (Hong Kong) Limited, a wholly owned subsidiary of the Company, of Mr. Dawei Mao as a director of Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), the Company's main operating subsidiary. Mr. Mao has replaced Ms. Xiaomin Yang, the President of Sinobioway Group Co., Ltd., as a director of Sinovac Beijing in accordance with applicable law and procedures. Additionally, the Board noted that Mr. Weidong Yin continues to serve as the Chairman, CEO and President of Sinovac.

Roslyn, New York, March 14, 2018 /PRNewswire/ -- Sino-Global Shipping America, Ltd. (NASDAQ: SINO) ("Sino-Global", the "Company" or "we"), a non-asset based global shipping and freight logistics integrated solution provider, announced today the closing of its previously announced registered direct offering and concurrent private placement with certain accredited investors to purchase a total of $3 million of its common stock, Series A Warrants and Series B Warrants.

Maxim Group LLC acted as sole placement agent for the offering.

After deducting the placement agent's commission and other estimated offering expenses payable by Sino-Global, the net proceeds to the Company were approximately $2.6 million. Sino-Global intends to use the net proceeds of the offering for general corporate purposes and working capital.


Wednesday, March 7, 2018

Notable Share Transactions
BEIJING, March 6, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (SVA), a leading provider of biopharmaceutical products in China, today announced that its board of directors has amended its shareholder rights plan.  The amendment extends the expiration date of the plan from March 27, 2018 to March 27, 2019.

Tuesday, March 6, 2018

Comments & Business Outlook

BEIJING, March 5, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today actions taken to enhance the corporate governance and management of Sinovac Biotech Co., Ltd. ("Sinovac Beijing"), the main operating subsidiary of Sinovac.

Sinovac Biotech (Hong Kong) Limited, a wholly owned subsidiary of the Company, has appointed Mr. Dawei Mao, Chairman of Zhongke Biopharmaceutical Co., Ltd., as a director of Sinovac Beijing. He has replaced Ms. Xiaomin Yang, the President of Sinobioway Group Co., Ltd.

Mr. Weidong Yin, Chairman, President and CEO of the Company, stated, "With the support of the board of directors of Sinovac Beijing, I will lead the team at Sinovac Beijing to continue to provide vaccines to eliminate human diseases."


Thursday, February 8, 2018

Going Private News

BEIJING, Feb. 7, 2018 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that, in connection with its previously announced going private transaction, the Company has filed a going-private transaction statement on Schedule 13E-3 (as amended, the "Going-Private Statement") with the United States Securities and Exchange Commission (the "SEC"). Attached as an exhibit to the Going-Private Statement is a preliminary proxy statement (the "Preliminary Proxy Statement"). The Company expects to file an amended Going-Private Statement, including a definitive proxy statement (which will be substantially in the same form as the Preliminary Proxy Statement and used in connection with a special meeting of shareholders) as an exhibit, with the SEC in due course.

As described more fully in the Going-Private Statement and the Preliminary Proxy Statement, the business to be transacted at the special meeting of shareholders includes shareholder approval of a proposal to authorize and approve an amalgamation agreement (the "Amalgamation Agreement") among the Company, Sinovac (Cayman) Limited, an exempted company incorporated with limited liability under the laws of the Cayman Islands, and Sinovac Amalgamation Sub Limited, an international business corporation incorporated under the laws of Antigua and Barbuda and a wholly-owned subsidiary of Parent, and the transactions contemplated by the Amalgamation Agreement, including the proposed amalgamation (collectively, the "Transactions"). The Amalgamation Agreement and the Transactions are more fully described in the Going-Private Statement and the exhibits attached thereto, including the Preliminary Proxy Statement. In addition, a copy of the Amalgamation Agreement is attached as an exhibit to the Preliminary Proxy Statement. The Company's shareholders are urged to review the Going-Private Statement and all of the exhibits thereto, including the Preliminary Proxy Statement and the Amalgamation Agreement, for more information regarding the Amalgamation Agreement and the Transactions.


Friday, December 1, 2017

Comments & Business Outlook

BEIJING, Dec. 1, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that it reported its unaudited financial results for the six months ended June 30, 2017.

Financial Highlights

Sales revenue for the first six months of 2017 was $66.9 million compared to $12.3 million in the prior year period, an increase of 442.6%. Sales increased primarily due to revenue generated by the Company's EV71 vaccine and a low comparison base in the second quarter of 2016 due to the Shandong vaccine scandal that negatively impacted the whole industry.
Net income attributable to common shareholders was $10.9 million, or $0.19 per basic and diluted share, compared to net loss attributable to common shareholders of $8.3 million, or $(0.14) per basic and diluted share, in the prior year period.
Business Highlights

Research and Development

Varicella - Sinovac obtained clinical research approval for its proprietary varicella vaccine candidate from the CFDAin September2015 and completed clinical trials in 2017. The production license application was submitted to the CFDA in November 2017.

EV71 - In November 2017, Sinovac obtained clinical trial approval to conduct a trial on healthy children aged from three to five years old. This vaccine was initially approved in January 2016 to target healthy children aged from six months to three years old. The Company made an application to conduct clinical study in an expanded population in April 2017.

Mr. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "In the first half of 2017, we experienced a year-over-year revenue growth of 442.6%. The revenue increase was mainly driven by the sales of EV71 vaccine that we commercialized in 2016. After the Shandong incident, sales activities resumed after a new policy on vaccine distribution and logistics was implemented at the beginning of 2017.This resulted inhigher first half sales of our regular vaccines, including Healive, Bilive, Anflu and mumps, than those of first half of 2016.

From the beginning of this year, we also had a few developments of our R&D programs. We filed production license application of our PPV-23, completed phase II trial of our Sabin-IPV, and completed phase III clinical trial of our varicella vaccine. We also filed an application of production license with CFDA for our varicella vaccine recently. We believe the pipeline products developments bring future growth potential. Sinovac will keep executing our strategy to develop and provide vaccines to address the unmet medical needs."

Sales from continuing operations in the first half of 2017 were $66.9 million compared to $12.3 million in the prior year period. Sales increased primarily due to revenue generated by the Company's EV71 vaccine and a low comparison base in the second quarter of 2016 due to the Shandong vaccine scandal.

Gross profit from continuing operations was $59.2 million compared to gross profit of $4.0 million in the prior year period. The increase was primarily due to the contribution of EV71 vaccine sales in the first half of 2017. Gross margin was 88.4% compared to 32.2% in the prior year period. The low growth margin in the first half of 2016 was due to higher inventory provision provided for the hepatitis A&B and mumps vaccines, higher idle capacity costs charged to cost of sales, and a negative gross profit for the hepatitis A&B vaccine due to higher sales returns provision provided in the first half of 2016 as a result of the Shandong incident.

Selling, general and administrative expenses in the first half of 2017 were $36.7 million compared to $14.5 million in the same period of 2016. The Company's selling, general and administrative expenses increased with the higher level of sales activity. The Company also incurred a cost of $0.8 million relating to the proposed privatization of Sinovac.

R&D expenses in the first half of 2017 were $8.8 million compared to $4.9 million in the same period of 2016. The increase was mainly due to higher R&D expenses on the varicella and sIPV vaccine projects in the first half of 2017.

Income from continuing operations was $15.8 million compared to loss from continuing operations of $14.2 million in the prior year period.

Net income attributable to common shareholders was $10.9 million, or $0.19 per basic and diluted share, compared to net loss attributable to common shareholders of $8.3 million, or $(0.14) per basic and diluted share, in the prior year period.

Non-GAAP EBITDA was $15.9 million in the first half of 2017 compared to a loss of $11.9 million in the prior year period. Non-GAAP net income from continuing operations in the first half of 2017 was $16.2 million compared to a loss of $13.1 million in the prior year period. Non-GAAP diluted earnings per share from continuing operations in the first half of 2017 were $0.20 compared to a loss of $(0.17) per share in the prior year period. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement.

As of June 30, 2017, cash and cash equivalents totaled $55.0 million compared to $62.4 million as of December 31, 2016. For the six months ended June 30, 2017 net cash provided by operating activities was $5.1 million. Net cash used in investing activities was $6.8 million, which was due to the purchase of equipment. Net cash used in financing activities was $6.7 million, including loan proceeds of $11.2 million and loan repayments of $17.9 million. As of June 30, 2017, the Company had $21.8 million of bank loans due within one year. The Company expects that its current cash position will be able to support its operations for at least the next 12 months. The Company will seek new commercial bank loans to finance the commercialization of its pipeline products and for other operational purposes when appropriate.


Friday, December 1, 2017

Investor Alert
BEIJING, Dec. 1, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) (the "Company" or "Sinovac"), a leading provider of biopharmaceutical products in China, announced today that it has received a Nasdaq Staff letter indicating that the Form 20-F filing delinquency, which was the subject of a prior Nasdaq Staff Determination letter, has been cured after the Company filed its annual report on Form 20-F for the year ended December 31, 2016 with the SEC on November 22, 2017. In the letter, Nasdaq indicated that the Company is in compliance with all applicable listing standards. As a result, the previously scheduled delisting hearing with the Nasdaq Listing Qualifications Panel has been canceled.

Thursday, November 30, 2017

Comments & Business Outlook
BEIJING, Nov. 30, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) (the "Company" or "Sinovac"), a leading provider of biopharmaceutical products in China, announced today that the Nasdaq Hearings Panel (the "Panel") granted the Company's request to extend the stay of suspension in trading of the Company's common shares pending a hearing on January 11, 2018 and issuance of a final Panel decision. On November 8, 2017, the Company appealed to the Panel the Nasdaq Staff's delisting determination dated November 1, 2017, and the Panel has scheduled a hearing on January 11, 2018.

Monday, November 6, 2017

Investor Alert

BEIJING, Nov. 3, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA) ("Sinovac"), a leading provider of biopharmaceutical products in China, announced today that on November 1, 2017, the Company received a delisting determination letter from the Staff of the Listing Qualifications Department (the "LQ Staff") of The Nasdaq Stock Market, Inc. ("Nasdaq ") related to the delisting of the Company's shares.

On May 10, 2017, the LQ Staff notified the Company that it did not comply with Nasdaq's filing requirements set forth in Listing Rule 5250(c)(1) (the "Rule") because it had not filed its annual report on Form 20-F for the year ended December 31, 2016 (the "2016 Annual Report"). The Company submitted a compliance plan on July 10, 2017, and the LQ Staff granted the Company an exception until October 30, 2017 to regain compliance with the Rule.

The Company has not yet filed the 2016 Annual Report. Accordingly, the LQ Staff has determined to delist the Company's shares due to the Company's failure to comply with the Rule. The delisting determination letter noted that the Company may appeal the LQ Staff's determination. However, if the Company does not appeal this determination, trading of the Company's shares will be suspended from The Nasdaq Select Global Market at the opening of business on November 10, 2017, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's shares from listing and registration on The Nasdaq Stock Market.

The Company intends to appeal the LQ Staff's determination and will request a hearing before the Nasdaq Hearings Panel as set forth in the Nasdaq Listing Rules.


Monday, September 25, 2017

Hot Bio-Tech News

BEIJING, Sept. 25, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of vaccines in China, announced today preliminary top-line data from its Phase III clinical trial assessing the efficacy, immunogenicity and safety of the Company's proprietary Varicella vaccine against Chickenpox.

The primary objective of the study was to evaluate the efficacy of the Varicella vaccine in the prevention of Chickenpox caused by Varicella-Zoster Virus (VZV). The preliminary Phase III data showed that Sinovac's Varicella vaccine was 87.1% (95% CI: 69.7%, 94.5%) efficacious against Chickenpox caused by VZV.

The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at two sites across China's Henan province. Approximately 6,000 healthy children from 1 to 12 years old completed the one dose vaccination schedule in the August of 2016, prior to the Chickenpox epidemic season in China, followed by an active monitoring period.

In parallel, Sinovac conducted another clinical study that was comprised of 1,197 volunteers and designed to evaluate the consistency of three consecutive lots of Varicella vaccine manufactured by the Company. The trial was conducted in children from 1 to 3 years old. After receiving the vaccine, the ratios of antibody GMTs on the 30th day of any two groups were calculated and the 95% confidence intervals of the ratios were all between 0.67 and 1.5, which indicates that the immunogenicity of the three vaccine lots is consistent. The study results showed consistent immune response for all three lots and a good safety profile. With immunogenicconsistency across the three consecutive lots, the results showed that Sinovac's vaccine production process and quality are stable. The production facility of Varicella vaccine has also reached commercial scale.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to report an over 87% efficacy rate from the Phase III trial of our Varicella vaccine. The conclusion of this trial means that we are on track for commercialization by the end of 2019 and marks an important milestone in our goal to  commercialize the varicella vaccine. Once commercialized, the Varicella vaccine will be supplied to meet existing market demand and support our subsidiary Sinovac Dalian in strengthening its financial position in the near future."

Sinovac obtained clinical research approval for its proprietary Varicella vaccine candidate from the CFDA in September 2015, and completed Phase I clinical trials in 2016. The preliminary results of the Phase I studies confirmed that Sinovac's vaccine candidate has a good safety profile.


Monday, August 14, 2017

Legal Insights

BEIJING, Aug. 14, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA)("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that The NASDAQ Stock Market ("NASDAQ") has accepted the Company's plan to regain compliance with NASDAQ Listing Rule 5250(c)(1) (the "Rule") and granted an exception to the Company to extend the deadline for complying with the Rule to October 30, 2017.The Company may regain compliance at any time before October 30, 2017 upon filing with the SEC its Annual Report on form 20-F for the year ended December 31, 2016 (the "2016 Annual Report").In the event that the Company does not satisfy the terms set forth in the extension, NASDAQ will provide written notification that the Company's common shares will be subject to delisting proceedings. At that time, the Company may appeal NASDAQ's determination for a panel review.

As announced previously, on May 1, 2017, the Company filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the "SEC") regarding the delayed filing of the 2016 Annual Report. On July 10, 2017, the Company submitted a compliance plan to NASDAQ to support its request for an extension of time to regain compliance with NASDAQ's continued listing requirements. The submission of the compliance plan is in response to a written letter from the Listing Qualifications Department of NASDAQ dated May 10, 2017 indicating that the Company was not in compliance with the Rule because the Company had failed to file the 2016 Annual Report within four months after the end of year 2016 and did not expect that it will be able to file the 2016 Annual Report within the 15-day extension period.

The 2016 Annual Report was delayed because Company's Audit Committee (the "Audit Committee") required additional time for its internal investigation regarding allegations raised in a research report by Geoinvesting. The investigation has slowed completion of the Company's financial statements and audit for the year ended December 31, 2016.The Company's management and the Audit Committee are continuing to work diligently to complete the 2016 Annual Report and file it with the SEC as soon as possible.

After the Company publicly announced the internal investigation arising from the Geoinvesting report, the SEC staff notified the Company of an enforcement inquiry related to the matters discussed in the article. The SEC staff subsequently issued a subpoena requesting documents related to the internal investigation. The Company, at the direction of the Audit Committee and with the assistance of independent counsel, has been cooperating with the SEC in response to the staff's requests for information.

In June 2017, the Company became aware of certain judgments based on bribery charges issued by Chinese courts in four provinces against various officials of the Chinese Center for Disease Control (the "CDC").  While these judgments appear to reflect an industry-wide investigation focused on CDC officials, they also referenced eight of the Company's former and current salespersons, together with sales personnel from several other Chinese vaccine companies and distributors.  However, these judgments did not name the Company or any of its directors, officers and employees as defendants. Upon becoming aware of these judgments, the Audit Committee expanded its internal investigation to review matters related to these judgments and the Company's sales practices and policies.

On July 3, 2017, a securities class action complaint was filed in the U.S. District Court for the District of New Jersey against the Company and three of its current and former officers: Mr. Weidong Yin, the Company's current chief executive officer, Ms. Nan Wang, the Company's current chief financial officer, and Mr. Danny Chung, the Company's former chief financial officer. The complaint asserts that statements in the Company's annual filings for fiscal years 2012 through 2015 were false and misleading because they failed to disclose matters relating to the alleged bribery incidents, among other allegations.  The Company is vigorously defending this lawsuit.

On July12, 2017, another securities class action complaint was filed in the Supreme Court of the State of New York against the Company and certain directors, among others. The complaint alleges that the Company's directors breached their fiduciary duties by, among other things, initiating a self-dealing going-private transaction at a per share consideration that is less than the true value of their investment in the Company. The complaint also alleges that the Company aided and abetted those alleged breaches of fiduciary duties by the Company's directors. The complaint seeks, among other things, an injunction preventing completion of the going-private transaction, damages (including rescissory damages) in favor of the plaintiff and the class, and the fees and costs associated with the litigation. The Company is vigorously defending this lawsuit as well.


Monday, August 14, 2017

Going Private News

BEIJING, Aug. 14, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA)("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that The NASDAQ Stock Market ("NASDAQ") has accepted the Company's plan to regain compliance with NASDAQ Listing Rule 5250(c)(1) (the "Rule") and granted an exception to the Company to extend the deadline for complying with the Rule to October 30, 2017.The Company may regain compliance at any time before October 30, 2017 upon filing with the SEC its Annual Report on form 20-F for the year ended December 31, 2016 (the "2016 Annual Report").In the event that the Company does not satisfy the terms set forth in the extension, NASDAQ will provide written notification that the Company's common shares will be subject to delisting proceedings. At that time, the Company may appeal NASDAQ's determination for a panel review.

As announced previously, on May 1, 2017, the Company filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the "SEC") regarding the delayed filing of the 2016 Annual Report. On July 10, 2017, the Company submitted a compliance plan to NASDAQ to support its request for an extension of time to regain compliance with NASDAQ's continued listing requirements. The submission of the compliance plan is in response to a written letter from the Listing Qualifications Department of NASDAQ dated May 10, 2017 indicating that the Company was not in compliance with the Rule because the Company had failed to file the 2016 Annual Report within four months after the end of year 2016 and did not expect that it will be able to file the 2016 Annual Report within the 15-day extension period.

The 2016 Annual Report was delayed because Company's Audit Committee (the "Audit Committee") required additional time for its internal investigation regarding allegations raised in a research report by Geoinvesting. The investigation has slowed completion of the Company's financial statements and audit for the year ended December 31, 2016.The Company's management and the Audit Committee are continuing to work diligently to complete the 2016 Annual Report and file it with the SEC as soon as possible.

After the Company publicly announced the internal investigation arising from the Geoinvesting report, the SEC staff notified the Company of an enforcement inquiry related to the matters discussed in the article. The SEC staff subsequently issued a subpoena requesting documents related to the internal investigation. The Company, at the direction of the Audit Committee and with the assistance of independent counsel, has been cooperating with the SEC in response to the staff's requests for information.

In June 2017, the Company became aware of certain judgments based on bribery charges issued by Chinese courts in four provinces against various officials of the Chinese Center for Disease Control (the "CDC").  While these judgments appear to reflect an industry-wide investigation focused on CDC officials, they also referenced eight of the Company's former and current salespersons, together with sales personnel from several other Chinese vaccine companies and distributors.  However, these judgments did not name the Company or any of its directors, officers and employees as defendants. Upon becoming aware of these judgments, the Audit Committee expanded its internal investigation to review matters related to these judgments and the Company's sales practices and policies.

On July 3, 2017, a securities class action complaint was filed in the U.S. District Court for the District of New Jersey against the Company and three of its current and former officers: Mr. Weidong Yin, the Company's current chief executive officer, Ms. Nan Wang, the Company's current chief financial officer, and Mr. Danny Chung, the Company's former chief financial officer. The complaint asserts that statements in the Company's annual filings for fiscal years 2012 through 2015 were false and misleading because they failed to disclose matters relating to the alleged bribery incidents, among other allegations.  The Company is vigorously defending this lawsuit.

On July12, 2017, another securities class action complaint was filed in the Supreme Court of the State of New York against the Company and certain directors, among others. The complaint alleges that the Company's directors breached their fiduciary duties by, among other things, initiating a self-dealing going-private transaction at a per share consideration that is less than the true value of their investment in the Company. The complaint also alleges that the Company aided and abetted those alleged breaches of fiduciary duties by the Company's directors. The complaint seeks, among other things, an injunction preventing completion of the going-private transaction, damages (including rescissory damages) in favor of the plaintiff and the class, and the fees and costs associated with the litigation. The Company is vigorously defending this lawsuit as well.


Monday, July 3, 2017

Going Private News

NEW YORK, June 30, 2017 /PRNewswire/ --To Acquire Sinovac Biotech (SVA) Sinobioway Consortium Raises Its Purchase Price To $8 Per Share.

On the evening of June 26, 2017 Beijing time, Sinovac Biotech Ltd. (Nasdaq: SVA, "Sinovac") announced that Sinovac entered into a Definitive Agreement ("Amalgamation Agreement") for Going-Private Transaction with Weidong Yin's consortium ("Consortium A") which is led by Weidong Yin and SAIF (Mr. Weidong Yin is the chairman, president and chief executive officer of Sinovac). Sinovac's Special Committee ("Special Committee") unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement. Pursuant to the Amalgamation Agreement, Weidong Yin's Consortium will acquire the Company for cash consideration equal to US$7.00 per common share of the Sinovac.

Just over 24 hours after the announcement above, Sinobioway Consortium ("Consortium B") rapidly submitted to Sinovac's Board of Director and the Special Committee a "Restate Offer" and raised the consideration for privatized acquisition to $8 per share, which is 14.3% higher than the consideration offered in the "Amalgamation Agreement."


Thursday, June 29, 2017

Going Private News

NEW YORK, June 28, 2017 /PRNewswire/ -- On the evening of June 26, 2017 Beijing time, Sinovac Biotech Ltd. (Nasdaq: SVA, "Sinovac") announced that Sinovac entered into a Definitive Agreement ("Amalgamation Agreement") for Going-Private Transaction with Weidong Yin's consortium ("Consortium A") which is led by Weidong Yin and SAIF (Mr. Weidong Yin is the chairman, president and chief executive officer of Sinovac). Sinovac's Special Committee ("Special Committee") unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement. Pursuant to the Amalgamation Agreement, Weidong Yin's Consortium will acquire the Company for cash consideration equal to US$7.00 per common share of the Sinovac.

Just over 24 hours after the announcement above, Sinobioway Consortium ("Consortium B") rapidly submitted to Sinovac's Board of Director and the Special Committee a "Restate Offer" and raised the consideration for privatized acquisition to $8 per share, which is 14.3% higher than the consideration offered in the "Amalgamation Agreement."

Consortium B was formed by Shandong Sinobioway Biomedicine Co., Ltd, CICC Qianhai Development (Shenzhen) Fund Management Co., Ltd, CITIC M&A Fund Management Co., Ltd., and some other famous institution. On February 3, 2016, Consortium B submitted an offer to the Special Committee with an initial consideration for $7 per share, which was 13.3% higher than consideration offered by the Consortium A at that time.

According to information from the Consortium B, the Special Committee did not give them the opportunity to raise their consideration. The Special Committee cooperated with the Consortium A, set the acquisition plan and the purchase price which is at an extremely low level.

Consortium B is concerned that the special committee did not fully select the acquisition method or choose the highest purchase price. It even did not give Consortium B or other potential acquirer the opportunities to raise the price. The members of Special Committee have become tools to help Consortium A erode the interests of minority shareholders.

To fight against this, Consortium B offers $8 in cash per Sinovac share and vows to win this transaction. How will Sinovac's going-private transaction go? We will wait and see.


Monday, June 26, 2017

Going Private News

EIJING, June 26, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that it has entered into a definitive amalgamation agreement (the "Amalgamation Agreement") with Sinovac (Cayman) Limited ("Parent") and Sinovac Amalgamation Sub Limited ("Amalgamation Sub"), a wholly owned subsidiary of Parent, pursuant to which Sinovac will be acquired by Parent in a transaction valued at approximately US$401.8 million.

Pursuant to the Amalgamation Agreement, Parent will acquire the Company for cash consideration equal to US$7.00 per common share of the Company (each, a "Share").  This represents a premium of 32.1% and 30%, respectively, over the Company's 30- and 60-trading day volume-weighted average price as quoted by NASDAQ prior to the Company's announcement on February 1, 2016 that it had received a non-binding "going-private" proposal from Mr. Weidong Yin, the chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. ("SAIF") and/or its affiliates to acquire all of the outstanding Shares not already owned by them.

The consideration to be paid to holders of Shares pursuant to the Amalgamation Agreement also represents an increase of approximately 13.3% from the original US$6.18 per Share offer price in the "going-private" proposal announced on February 1, 2016.

Immediately following the consummation of the transactions contemplated by the Amalgamation Agreement, Parent will be beneficially owned by a consortium (the "Buyer Consortium") comprising Mr. Yin, SAIF, C-Bridge Healthcare Fund II, L.P. ("C-Bridge Capital"), Advantech Capital L.P. ("Advantech Capital"), Vivo Capital Fund VIII, L.P. and Vivo Capital Surplus Fund VIII, L.P. (together with Vivo Capital Fund VIII, L.P., "Vivo Capital").  As of June 23, 2017, the members of the Buyer Consortium beneficially own in the aggregate approximately 29.5% of the issued and outstanding Shares.

Subject to the terms and conditions of the Amalgamation Agreement, at the effective time of the amalgamation, Amalgamation Sub will be amalgamated with and into the Company, with the Company continuing as the surviving corporation and a wholly owned subsidiary of Parent (the "Amalgamation"), and each of the Shares issued and outstanding immediately prior to the effective time of the Amalgamation will be canceled in consideration for the right to receive US$7.00 per Share in cash, without interest and net of any applicable withholding taxes, except for (i) 6,049,500 Shares held by Mr. Yin and 10,780,820 Shares held by SAIF (collectively, the "Rollover Shareholders"), (ii) Shares held by Parent, Parent's affiliates, the Company or any of the Company's subsidiaries, which Shares, in each case, will be canceled without payment of any consideration or distribution therefor and (iii) Shares owned by holders who have validly exercised and not effectively withdrawn or lost their rights to dissent from the Amalgamation in accordance with the provisions of Section 191 of the International Business Corporations Act, CAP. 222 of the Revised Laws of Antigua and Barbuda (as consolidated and revised) (the "IBCA"), which Shares will be canceled at the effective time of the Amalgamation for the right to receive the fair value of such Shares determined in accordance with the provisions of Section 191(4) or Section 195(2) of the IBCA, as applicable.

The Buyer Consortium intends to fund the Amalgamation through a combination of cash contributions from C-Bridge Capital, Advantech Capital and Vivo Capital or their respective affiliates pursuant to equity commitment letters.

The Company's board of directors, acting upon the unanimous recommendation of the special committee formed by the board of directors (the "Special Committee"), unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that the Company's shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.  The Special Committee, which is composed solely of independent directors of the Company who are unaffiliated with Parent, Amalgamation Sub or any member of the Buyer Consortium or management of the Company, exclusively negotiated the terms of the Amalgamation Agreement with the Buyer Consortium with the assistance of its independent financial and legal advisors.

The Amalgamation, which is currently expected to close during the second half of 2017, is subject to customary closing conditions, including approval by an affirmative vote of holders of Shares representing at least two-thirds of the Shares present and voting in person or by proxy as a single class at a meeting of the Company's shareholders, which will be convened to consider the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and the other closing conditions specified in the Amalgamation Agreement.  As of June 23, 2017, the Rollover Shareholders beneficially own in the aggregate approximately 29.5% of the issued and outstanding Shares.  Pursuant to a support agreement among the Rollover Shareholders, Parent and Sinovac Holding (Cayman) Limited, the sole shareholder of Parent, the Rollover Shareholders have agreed to vote all their Shares in favor of the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.  If completed, the Amalgamation will result in the Company becoming a privately-held Company and the Shares will no longer be listed on NASDAQ.


Wednesday, May 17, 2017

Comments & Business Outlook

BEIJING, May 17, 2017 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA)("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that it is delaying its Annual Report on Form 20-F for the year ended December 31, 2016 (the "2016 Annual Report") and that it received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market ("NASDAQ").

On May 1, 2017, Sinovac filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the "SEC") regarding the delayed filing of its 2016 Annual Report. Sinovac does not expect that it will be able to file the 2016 Annual Report within the 15-day extension period. The Company's Audit Committee requires additional time for its internal investigation regarding allegations raised in a research report by Geoinvesting. The investigation has slowed completion of the Company's financial statements and audit for the year ended December 31, 2016. Management and the Audit Committee of the Company's Board of Directors are continuing to work diligently to complete its 2016 Annual Report and file it with the SEC as soon as possible.

After the Company publicly announced the internal investigation arising from the Geoinvesting article, the SEC staff notified the Company of an enforcement inquiry related to the matters discussed in the article. The SEC staff subsequently issued a subpoena requesting documents related to the internal investigation. The Company, at the direction of the Audit Committee and with the assistance of independent counsel, is cooperating with the SEC in response to the staff's requests for information.

On May 10, 2017, Sinovac received a written notice from the Listing Qualifications Department of NASDAQ indicating that the Company is not in compliance with Listing Rule 5250(c)(1) because the Company has failed to file its 2016 Annual Report within four months after the end of year 2016 and does not expect that it will be able to file the 2016 Annual Report within the 15-day extension period.


Friday, December 23, 2016

Comments & Business Outlook

BEIJING, Dec. 23, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, today responded to a recent report regarding the allegations raised in a research report by Geoinvesting. 

Sinovac's Audit Committee has authorized the commencement of an internal investigation into the allegations made in the report. The Audit Committee has engaged Latham & Watkins as independent counsel to assist with the investigation. 

Pending the outcome of the investigation, to the knowledge of Sinovac, no legal proceedings or government inquiries have been made against the Company or its chief executive officer Mr. Yin, based on any claims described in the report.  


Monday, November 28, 2016

Comments & Business Outlook

Third Quarter 2016 Financial Results

  • Quarterly sales from continuing operations were $28.7 million compared to $16.8 million in the prior year period.
  • Non-GAAP diluted earnings per share from continuing operations in the third quarter of 2016 was $0.06, compared to net loss of $0.01 per share in the prior year period.

Mr. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "Our third quarter revenue rebounded from a slower first half of the year, increasing 71.4% to $28.7 million from $16.8 million from the same period of 2015. The sales improvement was mainly attributable to the newly introduced EV71 vaccine product sales, which contributed approximately $16.5 million to our quarterly revenue, partially offset by Bilive and Anflu revenue decreases."

"Vaccine deliveries resumed in the third quarter after the interpretation of new government regulation was issued in June, however we expect the market for conventional vaccines to take longer to fully recover. Our Bilive sales decline was due to increased sales returns as the delayed supply reduced the shelf life of the vaccine in the channel, while our Anflu sales decline was a result of less vaccine produced during this challenging environment."

"We continued to make progress on our pipeline programs with the continuation of clinical trials of our varicella vaccine, Sabin IPV (sIPV) and pneumococcal polysaccharide vaccine (PPV). Heading into the fourth quarter, we expect EV71 vaccine sales to remain our leading revenue contributor," concluded Mr. Yin.


Tuesday, August 23, 2016

Comments & Business Outlook

Second Quarter 2016 Financial Results

  • Quarterly sales from continuing operations were $1.4 million compared to $18.5 million in the prior year period.
  • Non-GAAP diluted net loss per share from continuing operations in the second quarter of 2016 was $0.15, compared to net income of $0.05 per share in the prior year period.

Mr. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "As forecasted on our first quarter earnings call, we experienced a continued decline to our financial results in the second quarter due to the incident involving the improper distribution and sale of vaccines in Shandong province. This impacted nationwide sales of private-pay market vaccines as vaccine companies halted vaccine delivery to wait for the interpretation of new regulation by the Chinese government."

"In mid-June, the China Food and Drug Administration ("CFDA") and China's Ministry of Health jointly issued an interpretation of the new requirement and execution plan during the transition period before the infrastructure is set up to fully comply with the new regulation. This allowed vaccine sales and delivery in the private-pay market to resume following the joint government announcement. Since then, we have experienced a rebound in sales activity. When the private-pay vaccine market was reactivated, our sales and marketing team launched marketing activities for promoting our newly approved EV71 vaccines. There have been vaccination kick-off ceremonies, commercial launch activities at the provincial level, as well as educational seminars and marketing activities, as planned. By now, we have delivered our EV71 vaccine to 16 provinces and three municipalities and we expect these numbers to keep increasing."

Mr. Yin also commended, "During the second quarter, we also made progress on our pipeline programs with the continuation of clinical trials of our varicella vaccine and completed preparation for the trials of our sIPV vaccine. We expect that sales in our fiscal second half of the year will be much stronger than the first half and look forward to updating our investors on our latest progress and achievements in the months ahead."


Friday, May 27, 2016

Comments & Business Outlook

First Quarter 2016 Financial Results

  • Quarterly sales from continuing operations were $11.0 million, an increase of 19.0% from $9.2 million in the prior year period. The sales increase was primarily due to the recognition of H5N1 revenue.
  • Net income attributable to common shareholders was $1.3 million, or $0.02 per basic and diluted share, compared to net loss attributable to common shareholders of $2.3 million, or $0.04 per basic and diluted share in the prior year period.

Mr. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "Our first quarter revenue increased by 19% from the prior year period, however, the revenue increase was due to revenue recognition from sales of non-core H5N1 vaccine, which contributed 58% of total sales in the first quarter. Other vaccine sales were lower because of the challenging environment in the Chinese vaccine industry. Business conditions for vaccine manufacturers in China like Sinovac have become more difficult in recent months due to an incident involving the improper distribution and sale of vaccines in Shandong province. As a result of this incident, China's State Council newly issued the Regulation on the Administration of Circulation and Vaccination of Vaccines (the "Regulation"). The Regulation requires all the vaccine sales in the private-pay market go through provincial tendering platform, prohibits distributors from selling vaccines, sets higher standards to ensure cold-chain conditions for vaccine delivery and storage from the manufacturer to CDC customers at county/district levels and requires vaccine manufacturing companies to be fully accountable for the product quality during the distribution process. Currently, most of the provinces have yet to establish the platform, and a detailed interpretation and execution plan associated with the Regulation has yet to be released by the central government, resulting in stagnated nationwide sales of private-pay market vaccines. While Sinovac was not directly implicated in the incident, our sales performance has been negatively affected and we also expect management and administration costs of vaccine distribution to increase in the future.

Mr. Yin added, "The Shandong incident had a material effect on our revenues in the first quarter and we expect that this trend will continue into the second quarter. Sinovac is well capitalized and the underlying need for vaccines has not changed.  We have taken steps to manage our cash carefully, including implementing a more stringent AR collection management scheme, ensuring commercial bank loans, and deferring non-core R&D projects to better enable Sinovac to withstand this unusual event. At the same time we will closely monitor the market conditions and the change of policy to prepare ourselves for full implementation once market conditions normalize. For long term, we are well positioned to benefit from these industry changes once the vaccine market recovers as our past success has been to primarily rely on our internal sales force instead of distributors, and we also expect to gain from the commercialization of our newly approved EV71 vaccine, positioning Sinovac to be more competitive."

Mr. Yin added, "In the first quarter, we initiated the production of our EV71 vaccine immediately after the vaccine was approved in January 2016. The EV71 vaccine produced has passed the lot release test administered by the National Institute of Food and Drug Control and is now ready for market launch. We expect to deliver the vaccine to customers once the market returns to normal. During the quarter, we have also made progress on our pipeline programs with the initiation of clinical trials of our varicella vaccine and our preparation for the trials of the sIPV vaccine. We will continue to keep our investors updated on our latest progress and achievements in the months ahead."


Thursday, April 14, 2016

Going Private News

BEIJING, April 14, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (SVA), a leading provider of biopharmaceutical products in China, announced that the independent special committee of the Company's Board of Directors, formed to consider "going private" proposals received by the Company, has appointed yesterday 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. Latham & Watkins is serving as U.S. legal counsel, and Delaney Law is serving as Antigua legal counsel, to the Company.

As disclosed previously, the Company's Board of Directors formed the special committee following the receipt of a non-binding "going private" proposal, dated January 30, 2016, from Mr. Weidong Yin, chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. and/or its affiliates. Subsequently, the special committee received a non-binding competing "going private" proposal, 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. The special committee will carefully consider and evaluate both proposals with the assistance of the special committee's financial and legal advisors.

The Company's directors caution the Company's shareholders and others considering trading in the Company's securities that no decisions have been made with respect to the Company's response to either proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that either proposal or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to these or any other transactions, except as required under applicable law.


Tuesday, April 5, 2016

Comments & Business Outlook

Fourth Quarter 2015 Financial Results

  • Quarterly sales from continuing operations were $23.0million, an increase of 13.1% from $20.3 million in the prior year period.
  • Net income attributable to common shareholders was $504 thousand, or $0.01 per basic and diluted share, compared to net income attributable to common shareholders of $1.3 million, or $0.02 per basic and diluted share in the prior year period.

Mr. Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "We achieved continued sales growth in 2015, despite a more challenging market environment for vaccine sales. Our total sales increased to $67.4 million in 2015, primarily due to the recognition of H5N1 vaccine revenue, in addition to consistent recurring sales from our core products. We were pleased with the milestone achievements of our product pipeline this past year. Our next core product, the EV71 vaccine, obtained its new drug certification, production license and GMP certification, and is now in commercial production. We expect to begin the sales of EV71 by June 30, 2016. The EV71 vaccine is the first innovative vaccine product successfully developed and commercialized by Sinovac and represents the first of several pipeline product candidates being developed to grow the business in the coming years. We look forward to improving our financial performance and enhancing our market position over the long term upon the commercialization of this product."

"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. We will continue to execute our strategies to advance our pipeline products and fuel further growth."


Thursday, February 4, 2016

Going Private News

BEIJING, Feb. 4, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. ("Sinovac" or the "Company") (SVA), a leading provider of biopharmaceutical products in China, today announced that the special committee of its board of directors received on February 4, 2016 a preliminary 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 the outstanding common shares of the Company for $7.00 in cash per common share. A copy of the proposal letter is attached hereto as Exhibit A.

The special committee of the Company's independent directors, which was formed to consider the preliminary non-binding proposal letter, dated January 30, 2016, from Mr. Weidong Yin, chairman, president and chief executive officer of the Company, and SAIF Partners IV L.P. and/or its affiliates will carefully consider and evaluate both proposals with the assistance of the special committee's independent financial and legal advisors to be appointed in due course.

The Company's directors caution the Company's shareholders and others considering trading in the Company's securities that no decisions have been made with respect to the Company's response to either proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that either proposal or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to these or any other transactions, except as required under applicable law.


Thursday, January 28, 2016

Hot Bio-Tech News

BEIJING, Jan. 28, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today that the China Food and Drug Administration ("CFDA") has issued the Good Manufacturing Practices ("GMP") certificate to Sinovac for the Company's Enterovirus 71 ("EV71") vaccine.

This marks the completion of the final step of approval prior to commercial production. The company has begun commercial production of the EV71 vaccine and expects to deliver the vaccine to the market prior to the end of the second quarter of 2016 after the lot release testing is completed. The designed annual production capacity is 20 million doses.

As previously announced, the CFDA issued the new drug certificate and production license for Sinovac's EV71 vaccine on December 30, 2015, which was followed by the public notification on the status of the GMP certification starting from January 5, 2016 to January 18, 2016.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The issuance of the GMP certificate has allowed us to begin commercial production of the EV71 vaccine. Sinovac has referenced the highest level of domestic and international quality standards throughout the development of the EV71 vaccine candidate and has established stringent controls to ensure product quality, safety and efficacy of the vaccine. After eight years under development, the EV71 vaccine demonstrates the proven capabilities of Sinovac's research and development efforts and significant achievements in the areas of etiology, epidemiology, vaccinology and clinical application. With the clinically-proven strong efficacy profile of our EV71 vaccine, we plan to collaborate with local CDC's to increase the vaccine coverage of this product and reduce the overall number of severe and fatal cases of Hand, Foot and Mouth Disease in China. We look forward to the broad adoption of our EV71 vaccine in the China market as well as the overseas market to provide a healthier environment for children globally with the protection of our EV71 vaccine."

About EV71

Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. However, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV71. A number of outbreaks of EV71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. No specific treatment for this enterovirus infection and no vaccine are currently available.

HFMD has become a very serious problem in China, some other Asian countries and other areas in recent years given that no vaccine and specific treatment is currently available to protect against this disease. EV71 has evolved into a severe health threat to children as a growing number of HFMD cases have been reported in parts of Asia, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. According to the Chinese Ministry of Health's data available for the period from January 1 to November 30, 2015, the disease caused 118 deaths in China and over 1.61 million HFMD infection cases during the 2015 eleven-month period, as reported by health authorities, as compared to 508 fatalities in China and over 2.82 million reported HFMD infectious cases for the entire year of 2014.


Monday, January 4, 2016

Hot Bio-Tech News

BEIJING, Jan. 4, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products inChina, today announced that the China Food and Drug Administration (CFDA) issued the new drug certificate and production license for its Enterovirus 71 ("EV71") vaccine.

As previously announced, the CFDA completed its Good Manufacturing Practices (GMP) inspection simultaneously with the site inspection of the EV71 vaccine production facility in October 2015, and will issue the GMP license after the new drug certificate and production license are issued. Sinovac expects to receive the GMP license in early 2016 and will start commercial production of EV71 vaccine immediately afterwards. The Company expects to deliver the vaccine to the market within four to five months after commercial production begins.

Sinovac's EV71 vaccine production facility is located in Beijing with an expected production capacity of 20 million doses annually. This vaccine will target children aged 6-35 months, with each child requiring a total of two doses one month apart from another.

The Company's EV71 vaccine sales will initially focus on the private pay sector of the Chinese vaccine market. Since its inception in 2001, Sinovac has grown its expertise in China's private vaccine market through selling hepatitis and flu vaccines. Targeting the private pay market enables Sinovac to take full advantage of its existing sales networks, including in-house sales team and third party distributors, to ramp up EV71 vaccine sales. Sinovac's sales and marketing team is actively finalizing the execution plan for the sales strategy of this product.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "This is a milestone development for our company. I am deeply appreciative of the hard work by many of our internal team members, particularly our R&D team, for bringing this vaccine closer to commercialization as well as the supportive efforts of the CFDA and the Chinese Center for Disease Control and Prevention (China CDC). I would also like to thank the thousands of volunteers involved in the human clinical trials for this vaccine, as well as to our long-term investors for their commitment to our company. After eight years of development, we are now very close to delivering our EV71 vaccine to the China market."

Mr. Yin continued, "EV71 vaccine is the first innovative vaccine product successfully developed and commercialized by Sinovac. We envision opportunities to collaborate with relevant government authorities to further test the safety and immunogenicity of the EV71 vaccine in order to provide scientific evidence of using this vaccine on a broader population. We also look forward to improved profitability and an enhanced market position upon the commercialization of this product, resulting in better returns for our shareholders."


Thursday, December 10, 2015

Hot Bio-Tech News

BEIJING, Dec. 10, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or "sIPV") candidate.

In preparation of beginning human clinical trials, Sinovac is currently finalizing the clinical trial protocol based on the clinical trial license. The Company plans to start the clinical trials in the first half of 2016 and expects to complete these trials by 2018. According to the approval, Sinovac will conduct human clinical trials to select the dosage and evaluate safety and immunogenicity of the vaccine candidate. The Company will use conventional Salk-IPV and Sabin-IPV on the market as control groups in the clinical trials. The Company will also evaluate the manufacturing consistency of three lots in the trials.

The Company plans to build a new commercial production facility of sIPV in an existing building at the Company's Changping site. The plant will have a designed annual capacity of ten million doses. The construction is expected to begin in 2016.

The clinical trial application for the sIPV was officially accepted by the China Food and Drug Administration (CFDA) in October 2014 and received fast track approval by the CFDA as part of the government's polio eradication efforts.

As previously announced, Sinovac has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV vaccine.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "As an inactivated polio vaccine different from conventional Salk-IPV, the clinical trial approval of our sIPV vaccine candidate represents a significant achievement. As we progress closer to commercialization, this vaccine is expected to open up additional opportunities in China's public market and also introduce overseas expansion opportunities by potential purchasing programs from international organizations. While national governments collaborate to promote IPV under the WHO's Polio Eradication & Endgame Strategic Plan, the world still faces limited production capability. With Sinovac's fully integrated vaccine capabilities and our commitment to providing children around the world with our vaccines, we are dedicated to making efforts for polio eradication both in China and around the world. In addition, the vaccine also contributes to our pipeline products portfolio diversification by providing us the opportunity to develop sIPV related combo vaccine in the future."


Monday, October 26, 2015

Comments & Business Outlook

BEIJING, Oct. 26, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that one of its subsidiaries, Sinovac Dalian, has received approval to begin human clinical trials on its varicella vaccine candidate. The clinical trial application for the varicella vaccine was officially accepted by the China Food and Drug Administration (CFDA) in January 2013.

In preparation to begin human clinical trials, Sinovac Dalian is currently finalizing the trial protocol, confirming the site, training staff and preparing for volunteer screening. The Company expects to complete the trial in 2017. Simultaneously, Sinovac Dalian is renovating of an existing building on its Dalian campus, which will serve as the commercial production plant for the varicella vaccine. The plant will have a designed annual capacity of 5 million doses.  

The Company's varicella vaccine candidate is a live attenuated vaccine derived from a human cell line. Development of the vaccine began in 2010 and the clinical trial application was officially accepted by the CFDA in January 2013, after the preclinical study was completed. The Company expects to be able to commercialize its varicella vaccine by the end of 2019. Ultimately, Sinovac plans to develop a measles-mumps-rubella-varicella (MMRV) combination vaccine. The Company has licensed a mumps vaccine for sale in China, has clinical trial approval for its internally-developed rubella vaccine and plans to begin development of a measles vaccine.

Currently, the varicella vaccine is sold exclusively in the private-pay market in China by four domestic producers. In some regions, the varicella vaccine is included in the emergency immunization programs of several provinces for free vaccination due to outbreaks. According to the China CDC, the varicella vaccine is recommended to children over 12 months with different immunization schedules implemented in different provinces and it's specified in the product specification. Generally, a one-dose scheme is recommended for children from 12 months to 12 years old and two doses for those 13 years and older. Recently, one booster shot has been recommended for children 4 to 12 years old by some local CDCs. This is expected to become standard protocol throughout the country in the coming years, which would increase market demand. In the past five years, approximately 15-16 million doses were released to China market annually.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Obtaining the clinical trial approval marks a significant step in the R&D process for our varicella vaccine candidate. Once commercialized, this vaccine will be supplied to the existing market demand and support Sinovac Dalian for its asset utilization, cash flow and profitability in the near future, and position us to capture share with the potential market expansion in the coming years. Meanwhile, there is a meaningful opportunity for an MMRV vaccine in the private-pay market in the future. This represents another milestone as we further develop our vaccine product portfolio to fulfill China's unmet medical needs."


Monday, September 14, 2015

Contract Awards

BEIJING, September 14, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that it has been selected by the Beijing government to be a supplier of the seasonal influenza vaccine for its 2015 vaccination campaign.

The Beijing government plans to order a minimum of 1.2 million doses of the seasonal flu vaccine from four manufacturers for its 2015 campaign. The exact quantity of doses to be ordered will depend on demand during the flu season. During the 2014 campaign, a total of 1.37 million doses of the flu vaccine were administered, of which Sinovac supplied 400,000 doses. Sinovac expects to begin delivering vaccines for the 2015 tender in the third quarter of 2015.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to be selected once again by the Beijing government to supply seasonal flu vaccines for Beijing citizens. This vaccination campaign is an important step in protecting geriatric and school-age populations from influenza."

The Beijing government began purchasing seasonal flu vaccines in 2007 to prevent and control the spread of influenza among populations most susceptible to complications from the virus. Each year, the Beijing government evaluates potential suppliers on product quality, service and price, among other factors.


Thursday, August 13, 2015

Comments & Business Outlook
Second Quarter 2015 Financial Results
  • Quarterly sales were $18.5 million, an increase of 53.1% from $12.1 million in the prior year period.
  • Net income attributable to common shareholders was $2.3 million, or $0.04 per basic and diluted share, compared to net loss attributable to common shareholders of $2.2 million, or $(0.04) per basic and diluted share, in the second quarter of 2014.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "I am very pleased to announce our strong sales and profitability during the second quarter. We continue to execute our strategy to drive sales while maintaining tight control over our operating costs. Although the general market environment remains the same as prior quarters, our sales results in the second quarter exemplify our team's ability to adjust to challenging market dynamics."

Mr. Yin continued, "Additionally, we continue to move forward in the approval process for our EV71 vaccine candidate. During July and August, CFDA inspectors have been conducting the site and GMP inspections of our manufacturing facility. The site inspection was completed last week and will be followed by sample testing. Our projected timing for EV71 commercialization remains unchanged. "


Friday, May 15, 2015

Comments & Business Outlook
First Quarter 2015 Financial Results
  • Quarterly sales were $9.3million, a decrease of 31.6% from $13.5 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."


Thursday, May 14, 2015

Comments & Business Outlook

BEIJING, May 14, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that the Company received site inspection notification for the commercial production facilities of its EV71 vaccine candidate from the China Food and Drug Administration (CFDA). This notification represents a significant step forward for the Company in its efforts to bring its EV71 vaccine to market.  

Following the notification, Sinovac will submit its application to schedule the site inspection, which will include production for three consecutive trial batches of the vaccine. Samples from the trial batches will be selected during the inspection and sent to the National Institutes for Food and Drug Control for testing. 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 and production license.

According to new regulation, vaccine manufacturers can apply for the GMP inspection to be conducted simultaneously with the site inspection. Results of the GMP inspection are submitted to the CFDA, which will then issue the GMP license once the new drug certificate and production license are issued.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "This is a significant milestone in the approval process for our proprietary EV71 vaccine. We are very pleased to be one step closer to bringing the vaccine to market and helping to mitigate the devastating impact of this disease in China."

EV71 is the primary cause of severe and fatal cases of hand, foot and mouth disease (HFMD) in China. According to the data published by the National Health and Family Planning Commission, there were over 2.8 million reported cases of HFMD in 2014, 508 of which were fatal.


Monday, April 20, 2015

Comments & Business Outlook

Fourth Quarter 2014 Financial Results

  • Quarterly sales were $20.3 million, a decrease of 11.4% from $22.9 million in the prior year period. Excluding revenue recognized from the stockpiling of H5N1 pandemic influenza vaccine of $0.1 million in the fourth quarter of 2014 and $7.2 million in the fourth quarter of 2013, the Company's fourth quarter 2014 regular product sales were $20.2 million, an increase of 28.2% from $15.8 million in the prior year period.
  • Net income attributable to common stockholders was $1.3 million, or $0.02 per basic and diluted share for the fourth quarter of 2014, compared to $5.8 million, or $0.10 per basic and diluted share, for the fourth quarter of 2013.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Although the overall vaccine market environment was challenging in 2014, total sales of our regular products increased by 1.8% year-over-year, which is in line with our expectations. This growth is primarily due to increased sales of our hepatitis A&B vaccine, Bilive, in the private-pay market, as well as our hepatitis A vaccine, Healive, and seasonal flu vaccine, Anflu, in the public-pay market.

"We continue to make progress on our pipeline vaccines. We have submitted all required supplementary documentation for our EV71 vaccine candidate and are in the final stages of the approval process. We had begun clinical trials on our pneumococcal polysaccharide vaccine (PPV) at the beginning of April 2015. In the fourth quarter of 2014, we submitted our investigational new drug application for our proprietary hepatitis B vaccine and a new generation of hepatitis A & B combination vaccine to the China Food and Drug Administration (CFDA). Most recently, in January 2015, our pneumococcal conjugate vaccine (PCV) was approved to begin human clinical trials. We believe the advancement of our pipeline programs will serve as catalysts for future growth of the Company."


Tuesday, March 17, 2015

Hot Bio-Tech News

BEIJING, March 17, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today provided updates on the Company's pipeline vaccines.

EV71 vaccine. The Company submitted supplementary documentation to the China Food and Drug Administration (CFDA) at the end of January 2015, as required following review of the new drug application (NDA) by an expert panel in November 2014. The CFDA has begun its review of the supplementary documentation. Sinovac maintains regular communication with relevant departments of CFDA, in order to be prepared for the upcoming on-site inspection, sample testing, and production and lot release after the product is commercialized. Once the on-site inspection and sample testing are successfully completed, Sinovac will receive the new drug certificate, production license and GMP license to begin commercial production of its EV71 vaccine.

EV71 is a virus that causes hand, foot and mouth disease (HFMD) and is the primary cause of most severe and fatal cases of hand, foot and mouth disease (HFMD) in China. According to the Chinese CDC, there were approximately 2.78 million reported cases of HFMD in 2014 and 508 fatal cases.


Monday, November 17, 2014

Comments & Business Outlook

Third Quarter 2014 Financial Results

  • Quarterly sales were $17.1 million, a decrease of 22.3% from $22.1 million in the prior year period, which includes recognition of a special order of pandemic influenza vaccine (H5N1) revenue of $3.6 million.
  • Net income attributable to common stockholders was $0.1 million, or $0.00 per basic and diluted share, compared to $2.3 million, or $0.04 per basic and diluted share, in the third quarter of 2013.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "In the third quarter, the vaccine market in China began to show signs of recovery after the lower demand in the first half of the year. Although our regular sales were still down from the third quarter last year, we are encouraged by the uptick in demand for our seasonal flu vaccine from the private-pay market as well as consistent hepatitis A vaccine tenders in the public market.

"We continue to expand our presence in international markets with high sales potential for our vaccines. The Mexican Ministry of Health recently renewed our GMP certificate for the seasonal influenza and hepatitis A vaccines. Also during the third quarter, we received our registration license for our seasonal influenza vaccine in Chile.

"We are continuing to make progress on our pipeline vaccines. The expert panel review for our EV71 vaccine is scheduled in November 2014, which is one step forward in the process of new drug appication of our EV71 vaccine. We have also finalized the clinical trial protocol for our pneumococcal polysaccharide vaccine (PPV) and expect to begin clinical trials by the end of 2014," Mr. Yin concluded.


Friday, August 15, 2014

Comments & Business Outlook

Second Quarter 2014 Financial Results

  • Quarterly sales were $12.1 million, a decrease of 30.7% from $17.5 million in the prior year period. Sales for the first six months were $25.6 million, a decrease of 6.8% YoY from $27.5 million.
  • Net loss attributable to common stockholders was $2.2 million, or $(0.04) per basic and diluted share, compared to net income attributable to common stockholders of $1.3 million, or $0.02 per basic and diluted share, in the second quarter of 2013.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "While sales were impacted during the second quarter by short-term challenges from the external market environment, we are continuing to grow our sales channels and make strong progress in the development of our pipeline vaccines."

"In July, we received the first tranche of our RMB 60 million government grant to build a dedicated facility for the production of the EV71 vaccine, which is currently under review by the Center for Drug Evaluation. During the second quarter, we received our clinical trial license for the pneumococcal polysaccharide vaccine (PPV) from the CFDA and expect to begin trials later this year."

"Although we experienced decreased sales in the second quarter, we remain confident in our ability to execute our proven sales and marketing strategies, and continue to develop new vaccines that are both effective and safe. We expect these initiatives to meaningfully contribute to our performance as market conditions improve." Mr. Yin concluded.


Wednesday, July 23, 2014

Contract Awards

BEIJING, July 23, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention ("Beijing CDC") to be a supplier of the seasonal influenza vaccine to the citizens of Beijing for 2014.

The Beijing CDC plans to order a minimum of 1.2 million doses of the seasonal flu vaccine this year from four domestic vaccine manufacturers for its vaccination campaign. Each manufacturer has agreed to supply no less than 300,000 doses. If required by the government, Sinovac may deliver additional vaccines. The exact quantity of doses to be ordered will depend on demand during the flu season. In 2013, Sinovac supplied approximately 400,000 doses of Anflu for the influenza vaccination campaign in Beijing. During last year's campaign, the Beijing CDC administered a total of approximately 1.49 million doses for free to its target population. The Company expects to begin delivering the vaccines in the third quarter of 2014.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to be selected once again by the CDC to supply seasonal flu vaccines for Beijing citizens. This vaccination campaign is an important step in protecting geriatric and school-age populations from influenza."

The Beijing CDC began purchasing seasonal flu vaccines in 2007 to prevent and control the spread of influenza among populations most susceptible to complications from the virus. Each year, the Beijing CDC evaluates potential suppliers on product quality, service and price, among other factors.


Monday, July 21, 2014

Hot Bio-Tech News

BEIJING, July 21, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Health Bureau as the sole supplier of inactivated hepatitis A vaccine in pre-filled syringe dosage to the Expanded Program of Immunization (EPI) for Beijing. The tender is valued at approximately 16 million RMB. The vaccines purchased by the Beijing Health Bureau will be used for the period from 2014 to 2016. The Company expects to begin delivery in the coming months upon the demand.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to have been selected again as the only supplier of the inactivated hepatitis A vaccine in PFS presentation to the EPI inBeijing. With superior safety profile and proven efficacy, Healive will continue to be administered to newborns using our easy-to-use, pre-filled syringes. We look forward to continuing to collaborate with government agencies to control and prevent diseases with top-quality vaccines both in China and around the world."

Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 and is currently available in adult and pediatric dosages. The hepatitis A vaccine has been included in China's national immunization program since February 2008.


Wednesday, June 25, 2014

Comments & Business Outlook

BEIJING, June 25, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that the value added tax (or "VAT") rate applied to the sales of Sinovac's vaccine products will be reduced to 3% from the current rate of 6%, according to a joint notice on reducing and unifying the value added tax (VAT) rate published by the Ministry of Finance of China and State Administration of Taxation of China. The notification will become effective July 1, 2014.

Mr. Weidong Yin, Sinovac's CEO and President commented, "The notification is favorable news for Sinovac. We expect this new policy will beneficially impact our future financial results including total sales and net income as sales revenue is recognized as the invoiced value of products sold minus VAT."


Thursday, May 22, 2014

Comments & Business Outlook

First Quarter 2014 Financial Results

  • Quarterly sales increased by 34.8% to $13.5 million from $10.1 million.
  • Net income attributable to common stockholders was $4,000, or $0.00 per basic and diluted share, compared to a net loss attributable to common stockholders of $2.0 million, or $0.04 per basic and diluted share.

Mr. Weidong Yin, Chairman, President and CEO, commented, "The 34.8% year-over-year top line increase marked a strong first quarter. The growth was driven by higher sales of our commercialized vaccines in China, especially from Bilive, our combined hepatitis A&B vaccine. Sinovac's sales team continued to execute its tailored sales and marketing strategy, and maximize the favorable competitive environment."

Mr. Yin continued, "In line with our mission to develop and commercialize vaccines that address unmet medical needs in China and other countries, we continue to advance our pipeline vaccine candidates and expand our portfolio. Obtaining regulatory approval to commence human trials of PPV is another milestone we achieved. Our clinical application for the varicella vaccines is under review by CFDA."

Mr. Yin concluded, "The technology transfer agreement with Intravacc for sIPV exemplifies Sinovac's strategy to expand its vaccine pipeline through external collaboration. As the administration of an inactivated polio vaccine will largely reduce the risk of paralysis associated with the live attenuated vaccine virus in OPV, Sinovac is at the forefront of bringing a safer and more affordable solution to the population worldwide. Under the World Health Organization's global polio eradication plan, sIPV has significant market potential for Sinovac both in China and international markets. We are poised to continue to expand our vaccine portfolio focused on the objective of providing high quality vaccines made in China to children around the world."


Monday, April 28, 2014

Hot Bio-Tech News

BEIJING, April 28, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China that focuses on the research, development, manufacturing and commercialization of vaccines, announced today that it has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV vaccine. In addition, Sinovac has committed to having the capacity to supply, or making arrangements for the supply of, sIPV to the public sector of other countries in sufficient quantities to make a meaningful contribution to meeting global demand (e.g. at least 20 million doses annually).

In developing countries around the globe including China, oral polio vaccine (OPV) is widely utilized to eradicate polio. OPV is a live attenuated formulation, which contains a weakened form of poliovirus. 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. To enable countries to maintain immunity levels, inactivated polio vaccines (IPV) will be introduced. Sabin IPV is both safer to manufacturer and 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 into 126 countries currently using OPV only by the end of 2015. According to Eradication and Endgame Strategic Plan developed under the Global Polio Eradication Initiative, from 2014 to 2018, the use of OPV in routine immunization will be gradually ceased.

The WHO called for Expressions of Interest (EOI) in 2010, 2011 and 2012 from private or public sector vaccine manufactures interested incollaborating with the WHO and Intravacc to develop and supply sIPV under the Global Polio Eradication Initiative. Sinovac submitted its EOI in 2012 and was selected as a technology transfer recipient after the qualification review and site inspection by the WHO and Intravacc.

National Health and Family Planning Commission of China is developing a vaccination strategy to add at least one dose of IPV into its national Expanded Program of Immunization (EPI). At present, no IPV is produced by manufacturers in China. Imported IPV became available in September 2009, but the supply is limited and the vaccine has to be paid for out-of-pocket by the recipient.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are honored to partner with WHO and Intravacc to develop and commercialize sIPV for future distribution both domestically and internationally. As part of selection process, we demonstrated our fully integrated vaccine capabilities, inclusive of conducting clinical trials, obtaining regulatory approval and operating GMP certified manufacturing facilities, and exemplified our commercialization expertise based on our broad vaccine portfolio."

Mr. Yin continued, "Polio represents a significant unmet medical need in China and other developing countries. By moving forward with the clinical development of sIPV with the objective of producing this vaccine in China, Sinovac is helping keep China polio-free and achieve a lasting polio-free world, free of all polio paralytic cases."

Ms. Gisella Frijlink, Chief Executive Officer of Intravacc, stated, "We are pleased to enter into the collaboration with Sinovac, one of the leading Chinese vaccine companies. This project will enable Sinovac to supply a safe and affordable sIPV vaccine to the Chinese population, as well as to other countries. It also exemplifies the leading position of the Netherlands in the vaccine field and Intravacc's important role in the global eradication of polio."


Thursday, April 24, 2014

Hot Bio-Tech News

BEIJING, April 24, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading China-based vaccine manufacturer, announced today that it has received notification that a RMB 60 million free government grant has been approved by China's Ministry of Finance, National Development and Reform Commission, Ministry of Industry and Information Technology, and National Health and Family Planning Commission for construction of the Company's dedicated production facility for its Enterovirus 71 (EV71) vaccine against hand foot and mouth disease (HFMD). Given the severity of HFMD epidemic levels in China and the government's focus on developing the biotechnology industry, Sinovac's EV71 vaccine commercial production project was approved as one of the projects supported by the Dedicated Funds for Strategic New Emerging Industry Development. The funding criteria as outlined in this grant are to complete the construction of its production facility in compliance with China's new GMP guidelines with an annual capacity of 20 million doses of EV71 vaccine and to commercialize the vaccine in China. The grant will be funded in several tranches, of which RMB 20 million will be provided within the year, and the remaining will be provided after the criteria are met.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "From 2007 to 2013, over 9 million cases of HFMD have reported in China with approximately 2,700 reported fatalities. This epidemic situation represents a significant unmet medical need for the EV71 vaccine. With the government support for building out the dedicated production capacity, Sinovac is poised to provide the EV71 vaccine to help address this potentially fatal childhood disease for which no commercialized vaccine and no EV71 specific treatment exist. The grant provides the confidence and encouragement that EV71 vaccine is urgently needed and has attracted the attention from the Chinese government. We look forward to working with the regulatory agencies to complete the vaccine registration process as soon as possible."

In March 2013, Sinovac completed the Phase III clinical trial for its EV71 vaccine candidate and reported preliminary top-line data that showed approximately 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (EV71). Throughout the three phases of the clinical trials, the results demonstrated a good safety, immunogenicity and efficacy profile for Sinovac's proprietary EV71 vaccine candidate. In May 2013, Sinovac's new drug application (NDA) for its proprietary EV71 vaccine has been filed and accepted by the China Food and Drug Administration ("CFDA"). Currently, the NDA is under the technological review by Centers for Drug Evaluation.


Thursday, March 20, 2014

Comments & Business Outlook

Fourth Quarter 2013 Financial Results

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

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. "


Thursday, February 27, 2014

Hot Bio-Tech News

BEIJING, Feb. 26, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that Phase III clinical trial results for its proprietary Enterovirus 71 ("EV71") vaccine have been 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 and 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.

The article, entitled "Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China," chronicles the results of the Phase III clinical trial on 10,077 healthy infants and young children in China (6 to 35 months of age) with a randomized, double-blind, placebo-controlled, multicenter trial method. The subjects were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either Sinovac's EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary endpoint was the occurrence of EV71-associated HFMD, or herpangina. The results showed the vaccine can provide protection against EV71 associated HFMD in infants and children.

According to the statistics from National Health and Family Planning Commission of China from 2008 to 2013, more than 9 million total cases of HFMD were reported, resulting in around 2,700 reported fatalities in China. According to an epidemiological study for the period of 2008 to 2012, around 80% of the severe cases and over 90% of fatal cases were caused by the enterovirus 71 (or EV71 ) infection.

Fengcai Zhu, M.D., Director of Jiangsu Centers for Disease Control and Prevention, co-principal investigator and lead author, said, "This study showed that the EV71 vaccine provides protection to the infants and young children against EV71-associated HFMD and the vaccine candidate has good safety and immunogenicity profile. HFMD has been an increasingly important public health issue among the young children in Asia-Pacific region, including China, and caused a significant social burden. The successful development of the EV71 vaccine is an exciting achievement by Sinovac, as it will provide an effective tool to protect infants and young children against EV71 associated HFMD, especially at the level of severe cases and potential fatalities."

Mr. Weidong Yin, Chairman, President and CEO commented, "The peer-reviewed publication in NEJM of our Phase III clinical trial results shows that our scientific contribution is acknowledged by the academia. The follow-up research is still ongoing. As there is no commercialized vaccine and no EV71 specific treatment available, there are increasing unmet medical needs. We are pleased to see that our vaccine is able to provide protection to infants and children against the EV71-associated HMFD. Sinovac is well prepared for the commercialization of this much needed vaccine. Once the regulatory approval is granted, we will be able to contribute to the overall control and prevention of this devastating disease."


Wednesday, January 29, 2014

Hot Bio-Tech News

BEIJING, January 29, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today that it has 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 CFDA on January 29, 2014. Incidence rates for H7N9 continue to increase in China, with 153 H7N9 Human infectious cases reported in 2013, according to the World Health Organization (WHO). In January 2014, 96 H7N9 cases were reported in China, including 20 fatalities.

Sinovac commenced development of its proprietary H7N9 vaccine at the beginning of 2013, when the continuous H7N9 infectious cases were reported in China. The H7N9 vaccine was developed utilizing Sinovac's existing flu vaccine development and production platform that includes its seasonal influenza vaccine, its pandemic influenza vaccine against H5N1 and its pandemic A(H1N1) vaccine. The Company obtained the avian influenza A(H7N9) virus strain from the WHO in May 2013. The Company has completed the pre-clinical research, and prepared different types of vaccine candidates for clinical testing. Once the CTA is approved, Sinovac is prepared to initiate the clinical trials in a timely manner.

Sinovac is the only company in China that is qualified to manufacture the vaccine against H5N1 avian flu following the regulatory approval in April 2008 and also was the first company globally to successfully develop and launch the H1N1 vaccine in September 2009.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "In line with our corporate mission to supply vaccines to eliminate human diseases, Sinovac had established a quick responding mechanism to provide vaccines to deal with the influenza pandemic, which has successfully applied to the development on H5N1 vaccine and H1N1 vaccine in the previous years. This time, the H7N9 vaccine was developed with the existing flu vaccine technology and production platform. The H7N9 vaccine will be produced in our existing flu facilities. We are well prepared to move forward with the clinical development to prove the safety and immunogenicity profile of the H7N9 vaccine candidates. We look forward to making our contributions to the prevention and control of avian influenza A(H7N9) virus."


Wednesday, November 13, 2013

Comments & Business Outlook

2013 Third Quarter Financial Results

  • Total quarterly sales increased by 54.5% to $22.1 million from $14.3 million.
  • Net income attributable to common stockholders was $2.3 million, or $0.04 per basic and diluted share, compared to net loss attributed to common stockholders of $3.0 million, or $0.05 per basic and diluted share.

 Mr. Weidong Yin, Chairman, President and CEO, commented, "We are pleased to see another strong quarter with revenue growth of 54.5% year-over-year, which resulted in another profitable quarter on a sequential quarterly basis. With continued execution of the tailored sales strategy, Anflu sales was increased by 121% in this quarter compared to the same period of 2012, resulted from a solid support from operation. Leveraging the improved efficiency and expanded capacity of our fully operational Changping filling and packaging line, we delivered the majority of the flu vaccine that we produced at the beginning of the seasonal flu season."

Mr. Yin concluded, "Our vaccine development pipeline is continuing to advance on schedule. The China Food and Drug Administration ("CFDA") issued new guidance in late October 2013 enabling applicants to apply for Good Manufacturing Practice ("GMP") certification for its production facilities concurrently with the production site inspection during the New Drug Application ("NDA") review process, instead of waiting until after the new drug certificate is granted to commence the GMP certification process. Sinovac is poised to benefit from the agency's revised guidance, which may accelerate the entire registration process for vaccine candidates, including EV71 vaccine."


Thursday, November 7, 2013

Contract Awards

BEIJING, Nov. 7, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading China-based vaccine manufacturer, announced today that it has been selected by the Jiangsu Centers for Disease Control and Prevention (Jiangsu CDC) to supply the Company's inactivated hepatitis A vaccine, Healive, under the Expanded Program of Immunization (EPI) in 2014 to the pediatric population in Jiangsu Province. The total volume of the tender is up to 1.8 million doses. As one of the two selected suppliers, Sinovac will supply 900,000 doses of Healive to Jiangsu province.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to be selected once again by the Jiangsu CDC as one of the two suppliers of inactivated hepatitis A vaccine pursuant to the tender for the 2014 EPI. We are advancing our strategy to collaborate with the government agencies to provide top-quality vaccines to prevent and control diseases in China and beyond."

Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 in China and is currently available in adult and pediatric dosage forms. In February 2008, the Chinese government included hepatitis A vaccine in its national immunization program.


Wednesday, August 14, 2013

Comments & Business Outlook

Second Quarter 2013 Financial Results

  • Total sales increased by 86.4% to $17.5 million from $9.4 million.
  • Gross profit increased by 70.1% to $13.6 million from $8.0 million.
  • Net income attributable to common stockholders was $1.3 million, or $0.02 per basic and diluted share, compared to net loss attributed to common stockholders of $1.6 million, or $0.03 per basic and diluted share.
  • Cash and cash equivalents totaled $92.0 million as of June 30, 2013, compared to $91.2 million as of December 31, 2012.

Dr. Weidong Yin, Chairman, President and CEO, commented, "We are pleased to report another quarter with strong sales rising by 86.4%, driven by robust hepatitis vaccines sales resulting from a favorable competitive environment in China and successful initiatives focused on each market segment implemented by our sales team. With this diversified sales strategy, Sinovac is poised to maximize the upcoming commercial opportunity for our EV71 vaccine for which the NDA filing is under review in China. The top line growth in the current period was the key driver of a higher gross profit and a higher net income as compared to previous quarters."

Dr. Yin continued, "The review of our NDA filing for our EV71 vaccine is also moving forward to the technological review process by the CDE. Hand, foot and mouth disease (HFMD) continues to represent a significant unmet medical need in China with reports of over 900,000 HFMD cases and 156 fatalities in first half of 2013. We aim to launch the EV71 vaccine to provide a solution to address this unmet medical need as no treatment and prevention options exist for this highly contagious disease impacting children in China and surrounding countries."

On July 30, 2013, following the completion of inspection on clinical sites by the Beijing Drug Administration, Sinovac's registration documentations for its proprietary EV71 vaccine were submitted to and accepted by the Center for Drug Evaluation (CDE), China Food and Drug Administration for the technological review on Sinovac's new drug application (NDA) filing.

On August 6, 2013, the phase II clinical results for Sinovac's proprietary EV71 vaccine were published online in The Journal of Infectious Diseases (JID), the premier global journal for original research on infectious diseases. The paper is entitled "Immunogenicity, Safety, and Immune Persistence of A Novel Inactivated Human Enterovirus 71 (EV71) Vaccine: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial."


Monday, June 3, 2013

CFO Trail

BEIJING, May 31, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products inChina, announced today that Ms. Nan Wang , Vice President of Sinovac, has been appointed as Chief Financial Officer, effectiveJune 1, 2013. Mr. Danny Chung , who was Chief Financial Officer, has resigned for family reasons.

Since joining the Company in 2001, Ms. Wang has served in different senior management roles inclusive of Vice General Manager of Sinovac Beijing, the Company's primary operating subsidiary, former General Manager of Sinovac Dalian, and as a member of the Board of Directors of Sinovac Beijing and Sinovac Dalian. She oversees Sinovac's business development, strategic management and investment.  She was instrumental in leading the Company's successful public offering in early 2010. Ms Wang previously served as Interim CFO in 2011 before Mr. Chung joined the Company. She is actively involved in the Company's investor relations activities. Ms. Wang received her Bachelor of Science degree in Biology from Peking University and her Master of Business Administration degree from the University of International Business and Economics, Beijing PRC. She also holds a Diploma in Financial Management, jointly issued by the Association of Chartered Certified Accountants (ACCA) and Beijing College for Entrepreneurs.

Mr. Weidong Yin , Chairman, President and CEO, stated, "For more than twelve years, Nan has served as a valuable member of Sinovac's senior management team and developed a wealth of experience in the vaccine sector, communications with investors, fundraising, and financial management.  We believe her business experience will bring additional value to the finance team as the Company prepares to grow with the introduction of new products.  On behalf of the Board, we appreciate Danny's contributions to the Company and wish Danny all the best in his future endeavors."


Thursday, May 30, 2013

Hot Bio-Tech News

BEIJING, May 30, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products inChina, today announced Sinovac's new drug application (NDA) for its proprietary EV71 vaccine has been filed and accepted by the Beijing Drug Administration. In terms of next steps for the NDA review process in China, the Beijing Drug Administration will conduct an on-site inspection on the circumstances of Sinovac's clinical trials and submit its on-site inspection opinion along with the application documentations to Centers for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) for further review and evaluation.

In March 2013, Sinovac completed the Phase III clinical trial for its EV71 vaccine candidate and reported preliminary top-line data that showed approximately 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (EV71). Throughout the three phases of the clinical trials, the results demonstrated a good safety, immunogenicity and efficacy profile for Sinovac's proprietary EV71 vaccine candidate. In China in 2012, 2.16 million cases of EV71 were reported along with 560 EV71 related fatalities in 2012.

In parallel, Sinovac's dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by CFDA.

Dr. Weidong Yin , Chairman, President and CEO, commented, "Filing the NDA  and receiving filing acceptance from the Beijing Drug Administration is a significant milestone as for the China regulatory process for our EV71 vaccine candidate. Due to the severe epidemic situation among children and infants in China, China Food and Drug Administration has been paying high attentions to the vaccine development and aim at supplying the high-quality vaccines against EV71 to the high-risk populations as soon as possible. As you may remember, in late 2010, Sinovac was approved by CFDA to continuously conduct all three phases of the human clinical trials on EV71 vaccine candidates instead of phase by phase approval as the standard process. And according to the results from phase III clinical trial, our vaccine candidate demonstrated approximately 95% efficacy rate against HFMD caused by EV71 among the 10,000 healthy volunteers, ages from 6 to 35 months old in Phase III trial and has the potential to address a significant unmet medical need facing the pediatric population in China and surrounding countries given the high fatality rates and rapid onset of this highly contagious disease."


Tuesday, May 28, 2013

Comments & Business Outlook

First Quarter 2013 Financial Results

  • Total sales increased by 68% to $10.1 million.
  • Gross profit increased by 90% to $7.1 million and gross profit margin percentage increased to 70% from 62%.
  • Net loss attributable to common stockholders was $2.0 million, or $0.04 per basic and diluted share, compared to a net loss of $5.6 million, or $0.10 per basic and diluted share, for the first quarter 2012.

Dr. Weidong Yin, Chairman, President and CEO, commented, "I am very pleased with the sales performance of our hepatitis A vaccine in the first quarter 2013, which is the primary driver to the total sales growth of 68% year-over-year. In the first quarter, the mumps vaccine manufactured by our Dalian site was commercialized, which also contributed to the sales growth in the first quarter."

Dr. Yin continued, "As our commercialized vaccines keep growing, our near-term pipeline product, the enterovirus 71 (EV71) vaccine, realized another significant milestone. Enterovirus 71 (EV71) vaccine remains to be a significant unmet medical need across China and Asia because of the widespread outbreaks of hand, foot and mouth disease (HFMD) caused by EV71 and significant pediatric mortality rates. In 2012, over 2 million cased were reported and over 500 fatal cased published by China National Health and Family Planning Commission ( or "NHFPC", previously named China Ministry of Health). We announced the approximately 95% efficacy rate of our proprietary EV71 vaccine from the phase III clinical trial on this vaccine. Based on the study results, our EV71 vaccine candidate has a good safety, immunogenicity and efficacy profile. The next step is to file the new drug application to Beijing Drug Administration in order to apply for the new drug certificate and the production license. And it is expected to launch in 2014."

"We are also committed to advance our other vaccine development pipeline. We have a few pipeline products, including varicella vaccine, pneumococcal vaccines and rubella vaccine that are under the evaluation by CFDA for granting a clinical trial approval. We believe the advancement of these product development programs will maintain our sustainable growth in long term."


Wednesday, May 15, 2013

Auditor trail

BEIJING, May 15, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products inChina, has appointed China-based Ernst & Young Hua Ming LLP as its registered independent public accounting firm effective fromMay 14, 2013 to replace Ernst & Young LLP Canada.

On May 14, 2013, Ernst & Young LLP Canada notified the Company that it would not stand for re-election as the Company's registered independent public accounting firm.

Both of the Company's audit committee and the board of directors have approved the appointment of Ernst & Young Hua Ming LLP to replace Ernst & Young LLP Canada. Ernst & Young Hua Ming LLP has begun providing services and is working with the Company and Ernst & Young LLP Canada to ensure a seamless transition. The Company believes that the appointment of Ernst & Young Hua Ming LLP is beneficial because of the close proximity to the Company's headquarters as the firm is also based in Beijing, China.

During the years ended December 31, 2012 and 2011, and through May 14, 2013, there were no disagreements with Ernst & Young LLP Canada on any matter of accounting principles or practices, financial statement disclosure, or auditing scope, or procedures.


Thursday, April 18, 2013

Hot Bio-Tech News

BEIJING, April 18, 2013  /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of vaccines in China, announced today that Fengcai Zhu, Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, presented data regarding Sinovac's proprietary enterovirus 71 ("EV71") vaccine against hand, foot and mouth disease ("HFMD") at the 13th Annual World Vaccine Congress & Expo, taking place from April 16-18, 2013, in Washington D.C. Dr. Fengcai Zhu acted as a co-principal investigator in Sinovac's phase III trial for its EV71 vaccine.

Dr. Fengcai Zhu delivered a presentation entitled "The clinical evaluation of new vaccines in China," at 12:25 pm EDT on April 17, 2013. In his presentation, Dr. Fengcai Zhu discussed the efficacy and safety of the Company's EV71 vaccine. Data from the Phase III trial indicated that our EV71 vaccine had 95% efficacy against EV71-associated HFMD /herpangina, and 100% efficacy against EV71-associated hospitalization.  Herpangina is a painful mouth infection that can be caused by EV71.

There were no significant differences between the vaccine group and the placebo group for the adverse reaction symptoms and incident rate in the phase III trial.

The double-blinded, randomized, placebo controlled phase III clinical trial was conducted at three sites across China's Jiangsuprovince. Approximately 10,000 healthy infants completed the two-dose vaccination schedule (at day 0 and day 28) in the first quarter of 2012, prior to the HFMD epidemic season in China. Trial participants were then followed in an active monitoring period.

 

BEIJING, April 18, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines inChina, announced today that it has received the Certificate of Approval to commercialize seasonal flu vaccine in Mexico by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of the Mexico Ministry of Health. The certificate of commercial approval is valid from April 1, 2013 to April 1, 2018. The Company filed the application to distribute Anflu in Mexico in 2005, and received the GMP certificate for its seasonal flu and hepatitis A vaccines on August 11, 2011.

Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company operating in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in Mexico, pursuant to a distribution agreement signed in 2005 with its affiliate.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, said, "This is a great milestone for Sinovac as we look to continue expanding our commercial efforts worldwide. We are pleased to receive approval to supply Anflu in the Mexican market, which we perceive as a significant opportunity outside of China. We expect to begin sales planning for Mexican market in conjunction with our partner, Laboratorios Imperiales, in the coming days."

 


Tuesday, September 25, 2012

Comments & Business Outlook

BEIJING, September 25, 2012 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that it has been selected by the Beijing Health Bureau and the Shanghai Centers for Disease Control and Prevention (Shanghai CDC) to supply the Company's inactivated hepatitis A vaccine, Healive, to the Expanded Program of Immunization (EPI) for each city. The tenders awarded to Sinovac in Beijing and Shanghai are valued at approximately 20 million RMB and 13 million RMB, respectively. The vaccine purchased by the Beijing Health Bureau will be administered over a two year period to the pediatric population across the city. The vaccine purchased by the Shanghai CDC is for the 2012 pediatric population inoculation program.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to have been selected as the sole supplier of the inactivated hepatitis A vaccine in prefilled syringe in both Beijing and Shanghai. Given its superior safety profile and proven efficacy, Healive will be provided to newborns under the Beijing and Shanghai immunization programs using our easy-to-use pre-filled syringes. We will continue to collaborate with government agencies to provide top-quality vaccines to prevent diseases in China and beyond."

Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 in China and is currently available in adult and pediatric dosage forms. In February 2008, the Chinese government included hepatitis A vaccine in its national immunization program.


Tuesday, September 18, 2012

Hot Bio-Tech News

BEIJING, September 18, 2012 /PRNewswire/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that it has received GMP certification from the China State Food and Drug Administration (SFDA) for the Company's dedicated mumps vaccine production plant at its Sinovac Dalian facility. The SFDA issued a public announcement on September 12, 2012, stating that the Good Manufacturing Practices (GMP) certification was issued to Sinovac with the certificate number CN20120080.

The SFDA issued a public notification in July 2012 stating that Sinovac Dalian's mumps vaccine production plant is in compliance with the new GMP guidelines (2010 version) following the site inspection and documentation review. The Company obtained the production license from the SFDA for its mumps vaccine in December 2011. Sinovac continues to anticipate that it will be in a position to commence commercial production of the mumps vaccine in the third quarter 2012 and is on track to launch the mumps vaccine in China following the batch release process.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Obtaining GMP certification for the mumps vaccine production facility is a significant milestone as we advance our development pipeline and expand our portfolio of commercialized vaccines. We are poised to leverage our established sales and marketing team and distribution network that covers over 1,000 clients at Centers of Disease Control and Points of Vaccination across China. The commercialization of mumps vaccine is a testament to our capabilities to develop additional live attenuated vaccines. Commercial production of the mumps vaccine will commence immediately and we anticipate launching the vaccine either later this year or early next year following the batch release process."

Approximately 13 million doses of mumps vaccine were released by National Institutes for Food and Drug Control (NIFDC) in 2011, and a total 3.15 million doses of mumps vaccines have been released for the eight months through August 2012. Currently, only two companies are providing the mumps vaccine in the China private market, both of which are domestic manufacturers. The launch of the mumps vaccine is Sinovac's first step towards developing a combination MMR (measles, mumps and rubella) vaccine, which is now included in the expanded program of immunization (EPI) and garnered increasing market demand in recent years


Wednesday, August 15, 2012

Comments & Business Outlook

2012 Second Quarter Financial Highlights (year-over-year comparisons to second quarter 2011)

  • Total sales of core vaccines (hepatitis A, hepatitis A&B, and seasonal influenza) were $9.4 million, up 17.6% with Bilive (hepatitis A&B) sales up 25.8%. Total sales decreased 40.2%, compared to the same quarter in 2011 due to the non-core government stockpile H5N1 pandemic flu vaccine sales of $7.7 million booked during that quarter.
  • Gross profit margin based on core vaccine sales was 85.3%, compared to 84.2% in the same period of last year. Overall gross profit margin for the same period 2011 was 68.8%, due to revenue recognition of H5N1 vaccine with lower gross margin in the second quarter of 2011.
  • Net loss attributable to common stockholders was $0.9 million, or $0.02 per basic and diluted share.
  • Cash and cash equivalents totaled $89.4 million as of June 30, 2012, compared to $94.5 million as of March 31, 2012 and $104.3 million as of December 31, 2011, respectively.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Our financial results for the first half of 2012 clearly demonstrate the management team's progress in executing on our business strategies. We continue to aggressively expand our hepatitis A&B vaccine business in the private pay market, and we believe that we can leverage this experience when we commercialize our EV71 vaccine and other pipeline products inChina. Besides strengthening our capability in the private market, we have been making significant efforts to expand our presence in the public market. Recently, we attribute winning the Gansu tender to the development of our public pay market sales initiatives."

Dr. Yin continued, "The Company's increased investment in R&D is driven by our EV71 Phase III trial, which is continuing in line with our targeted schedule. We are pleased to see the progress we have made in this Phase III clinical trial. The healthcare professionals participating in the trial are actively collecting the required data based on the quality and quantity specified in the protocol for the efficacy analysis of the vaccine candidate. In parallel with the clinical trial, the preparation of our dedicated EV71 vaccine production plant is underway. We anticipate that once the clinical trial is completed and after SFDA approval is obtained, we can immediately apply for the GMP certification for the plant, and make sure the EV71 vaccine product can be launched into the market without delay."

Dr. Yin continued, "We are on track to receive the GMP certification for our mumps vaccine. We are very pleased to see that after more than two years of development, Sinovac Dalian's first product is expected to be launched into the market in the coming months. This product will be the first mumps vaccine launched domestically which is manufactured in the plant that is in compliance with the new GMP standards in China."

Dr. Yin concluded, "Our strong cash position and secured credit line with a local commercial bank ensure our short-term investment needs on pipeline product development and facilities to drive the short-term and medium-term growth."


Monday, June 25, 2012

Comments & Business Outlook
BEIJING, June 25, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD). Full release.

Monday, June 11, 2012

Hot Bio-Tech News

BEIJING, June 11, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced a positive SFDA inspection of the three clinical trial sites being used in the Company's Phase III study of its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).

In May 2012, an expert from the Center for Drug Evaluation within the State Food and Drug Administration (SFDA) completed an inspection of the three Phase III study sites in Jiangsu Province, as well as the central laboratories set up by the Chinese Center for Disease Control and Prevention (CDC), according to the Good Clinical Practice (GCP) guidelines. As part of the inspection, study investigators from the three sites presented reports on the site's procedures of vaccination, safety monitoring and case surveillance, and the EV71 epidemic situation. The inspector also assessed the management systems at the three central laboratories, and their compliance with standard operating procedures.

After the inspection, the SFDA expert positively acknowledged the comprehensive surveillance work performed by the clinical sites, and confirmed its importance to the clinical evaluation of the EV71 vaccine. Additionally, the SFDA expert indicated that the site inspection would facilitate further interaction between the SFDA and the investigators to solve any problems or issues that may arise during the study period, which will be beneficial as the Company advances through the regulatory process.

Dr. Weidong Yin, Chairman, President and CEO, said, "With no specific treatments for EV71 and no effective prevention methods, we are continually reminded of the importance of rapidly developing a high quality vaccine against Enterovirus71. By simultaneously conducting the EV71 vaccine Phase III trial, maintaining ongoing discussions with the SFDA and preparing our dedicated production facility, we intend to address this unmet need by being well positioned to provide this vaccine to our children soon after it is approved. We remain on track to complete Phase III of the trial before the middle of next year."


Tuesday, May 15, 2012

Comments & Business Outlook

Financial Highlights (year-over-year comparisons to first quarter 2011)

  • Sales increased 30.3% to $6.0 million, with Bilive vaccines sales up 92.4%.
  • Gross margin was 62.2%, which included higher costs due to planned low production level of the animal vaccine facilities in conjunction with its recent launch. Without these costs gross margin would have been 65.1%.
  • Net loss attributable to common stockholders was $5.6 million, or $0.10 per basic and diluted share.
  • Cash and cash equivalents totaled $94.5 million as of March 31, 2012, compared to $104.3 million as of December 31, 2011.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The positive vaccine sales trend continued in the first quarter of 2012, which represented a good start for the year as the domestic vaccine market remains favorable. The positive effects of this market can be seen especially in the sales of Bilive, our combined hepatitis A and B vaccine, which increased by 92% year over year. We attribute this increase primarily to our sales and marketing experience and capabilities accumulated and improved in the private sector of the Chinese vaccine market over the past few years. We believe our increased strength in sales and marketing in the private market will also benefit the commercialization of other key products in our pipeline. Additionally, we are pleased to see that approximately 9% of our sales this quarter were generated from international markets. As our international sales team grows and the GMP standard in Chinaimproves, the Company is well positioned to take advantage of the opportunities across international markets. In general, our team will continue executing on its strategies to expand commercialized vaccine product sales."

Dr. Yin continued, "We are committed to advancing the development of our vaccine pipeline, which we believe will contribute to the Company's future growth. In the first quarter of 2012, we have substantially completed the key steps of the Phase III clinical trial for our EV71 vaccine, including the inoculation of, and blood collection from, these volunteers. The HFMD epidemic situation is becoming more serious, which not only indicates how important it is to develop our vaccine, but also allows for collection of sufficient data to evaluate the efficacy of the vaccine candidate in the Phase III study. In parallel with the vaccine development, the preparation of our dedicated EV71 vaccine production plant is underway to ensure that the vaccine is ready for commercial use soon after it is approved. "


Monday, May 14, 2012

CFO Trail

BEIJING, May 14, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, has appointed Mr. Danny Chung as Chief Financial Officer, effective immediately. Ms. Nan Wang, who has served as interim Chief Financial Officer since August 2011, will continue as the Company's Vice President.

"Mr. Chung possesses the relevant experiences and credentials, which meet the Company's needs," said Dr. Weidong Yin, Chairman and CEO. "Beyond his audit and accounting expertise, Mr. Chung has proven adept in the financial management of Chinese divisions of multinational companies. We are pleased to welcome him to Sinovac."

Mr. Chung has joined the Company since November 2011 as Sinovac Beijing's finance director, who brings to Sinovac over 20 years of experience in audit and financial management including healthcare industry. Mr. Chung graduated in 1983 from the Hong Kong Polytechnic and obtained a Professional Diploma in Accountancy. He has held professional membership in the U.S. Institute of Certified Public Accountants since 1990.


Thursday, March 29, 2012

Comments & Business Outlook

Fourth Quarter 2011 Results

  • Sales in the fourth quarter 2011 increased 131.3% year-over-year to $21.1 million, compared to $9.1 million, and full year sales increased 70.2% to $56.8 million.
  • Net income attributable to stockholders in the fourth quarter 2011 was $2.8 million, or $0.05 per basic and diluted share. Full year net loss attributable to stockholders was $845,000, or $0.02 per basic and diluted share.
  • Operating cash flow in the fourth quarter was $16.6 million, up 40.6% compared to $11.8 million in the same period of last year. Compared to a cash outflow of $14.3 million in 2010, operating cash inflow in 2011 was $13.9 million.
  • Cash and cash equivalents and short-term investments with guaranteed income totaled $104.3 million as of December 31, 2011, compared to $94.2 million as of September 30, 2011 and $103.1 million as of December 31, 2010.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "I am very pleased with our sales performance this year, especially for Bilive, which has been instrumental in expanding our private market share and increasing our revenue from private market in China. In 2011, we have gained traction in the public market and won tenders in Xinjiang Uyghur Autonomous Region, Shanghai and Beijing. While the Chinese vaccine market is recovering from unfavorable factors that occurred in 2010, we have nonetheless expanded our sales to overseas markets. We are now exporting vaccines to Mongolia, Nepal and the Philippines, and we focused on entering Mexico in 2012, subject to receipt of requisite local market clearance. In 2012, our sales team will continue its efforts to execute its sales strategies to expand existing commercialized vaccine products and we expect both of our animal rabies vaccine and mumps vaccine to contribute revenue to the Company this year."

Dr. Yin continued, "We are committed to advancing the development of our vaccine pipeline. Since there is no EV71 specific prevention method to help control the spread of HFMD, our development of this vaccine addresses a significant unmet medical need as recognized by the governments and parents across Asia. As such, advancing the clinical development of our proprietary EV71 vaccine is our highest priority program. Following the positive results from phase I and phase II clinical trials for our EV71 vaccine in 2011, we commenced the phase III clinical trial in January 2012. We have enrolled approximately 10,000 healthy volunteers, and completed the two shot inoculation schedule and the blood samples collection on the 56th days after the first shot. We are collecting the epidemic situation data surrounding the clinical site and this data will be utilized to assess the vaccine's efficacy. We anticipate completing the clinical trial in the first half of 2013. Meanwhile, the construction of a dedicated EV71 vaccine production plant is progressing on schedule at our Changping site in Beijing."

Dr. Yin concluded, "In addition to improving our operating efficiencies, we continue to manage proactively our strong cash position, which provides ample resources to support our near-term R&D programs and production capacity expansion for our new vaccines. We are prudently investing in future growth for the long-term interest of our shareholders. "


Wednesday, January 25, 2012

Investor Alert

BEIJING, January 25, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines in China, today announced that it received a letter dated January 18, 2012 from The Nasdaq Stock Market. Based on the departure of Ms. Chup Hung Mok from the Company's Board of Directors effective January 4, 2012, Nasdaq has determined that the Company no longer complies with Nasdaq's requirement that its audit committee consists of at least three independent directors, as set forth in Listing Rule 5605. However, consistent with Listing Rule 5605(c)(4), Nasdaq will provide the Company a cure period in order to regain compliance of until the earlier of the Company's next annual shareholders meeting or January 4, 2013; or if the next annual shareholders' meeting is held before July 2, 2012, then the Company must evidence compliance no later than July 2, 2012.

As announced on January 4, 2012, the Board has an active search ongoing to locate a suitable replacement for Ms. Mok. The Company intends to submit to Nasdaq documentation, including biographies of any new directors, evidencing compliance with the rules no later than this date.


Tuesday, January 10, 2012

Comments & Business Outlook

BEIJING, January 10, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that the phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD) has begun. The Phase II trial, completed in November 2011, confirmed favorable safety and tolerance profiles, and good immunogenicity.

According to the results of phase II clinical trial, the formulation of 400U with aluminum adjuvant was selected to be used in phase III clinical trial to evaluate the efficacy of Sinovac's EV71 vaccine in protecting against HFMD. The Phase III clinical trial is expected to enroll up to 10,000 healthy volunteers with ages 6-35 months, and was designed as a randomization, double blinded, placebo controlled study. The vaccination schedule calls for two shots at 0 and 28 days. Sinovac anticipates the trial to be completed in the first half of 2013.

Dr. Weidong Yin, Chairman, President and CEO, stated, "Commencing the Phase III EV71 vaccine trial is a significant milestone. The enrollment was completed. And inoculation was initiated late last week and is going on well. The first shot to 10,000 volunteers is anticipated to be completed within one month. The advancement of the clinical program demonstrates our integrated clinical team's ability, as seen with our positive results from the Phase I and II clinical trials. The EV71 vaccine addresses a significant unmet medical need with over 5.14 million HFMD infection cases documented in China since 2007 with over 1900 fatal cases."

Dr. Yin continued, "In parallel to the clinical development, Sinovac's engineering team is building a dedicated manufacturing facility for the EV71 vaccine. We aim to complete the construction and to obtain a GMP certificate in 2013."


Monday, November 14, 2011

Comments & Business Outlook

Third Quarter 2011 Results

  • Sales in the third quarter increased 60.8% year-over-year to $15.4 million, compared to $9.6 million, and year-to-date sales increased 47.2% to $35.7 million.
  • Net loss attributable to stockholders in the third quarter was $2.1 million, or $0.04 per basic and diluted share. Year-to-date net loss attributable to stockholders was $3.6 million, or $0.07 per basic and diluted share.
  • Cash and cash equivalents and short-term investments with guaranteed income totaled $94.2 million at September 30, 2011, compared to $92.7 million at June 30, 2011 and $103.1 million at December 31, 2010.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Our third quarter 2011 sales reflected the continued demand for our hepatitis vaccines, which represent about two-thirds of the sales this quarter. Bilive revenue growth still remains significant in this quarter.The vaccine is sold in the private pay market, and recently went through a price increase that improved its margin contribution and represents a key opportunity for sales expansion. We are making significant progress in growing public market sales of Healive, which represented 24% of total third quarter sales, compared to 8% in the same period in 2010. And this year, Sinovac successfully won the Beijing Governmental tender to supply our seasonal influenza vaccine to the citizens of Beijing for the fourth time in recent years, which shows that our flu vaccines are trusted by the CDCs."


Friday, August 12, 2011

Comments & Business Outlook

Second Quarter 2011 Financial Highlights

  • Sales increased 52.5% year-over-year to $15.7 million, compared to $10.3 million.
  • Net income attributable to shareholder reached $1.32 million and EPS was $0.02 per share vs $0.02 in 2010
  • Cash and cash equivalents and short-term investments, which the principal and income were guaranteed, totaled $92.7 million at June 30, 2011, compared to $103.1 million at December 31, 2010.

 "We are encouraged by the second quarter sales activity and public market orders received in recent months. We believe that the ongoing execution of our revised sales strategy and seasonal flu vaccine sales that typically take place in the second half of the year will enable continued revenue growth. We look forward to updating you on the continued progress across our vaccine development pipeline."


Sunday, August 7, 2011

Liquidity Requirements
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.

Friday, August 5, 2011

CFO Trail

BEIJING, August 5, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today the resignation of Jacob Chik Keung Ho, its Chief Financial Officer, for personal reasons. The Company has initiated an executive search for a new Chief Financial Officer to replace Mr. Ho, who has agreed to remain with the Company until August 16, 2011. Ms. Nan Wang, Vice President of Sinovac, has been appointed as the Interim Chief Financial Officer.

Ms. Wang has served as the Vice General Manager of Sinovac Beijing, the Company's primary operating subsidiary, since 2001, and in other senior management roles. She oversees Sinovac's business development, strategic management and investment. She was instrumental in leading Sinovac's successful public offering in early 2010. Ms. Wang received her Bachelor of Science degree in Biology from Peking University and her Master of Business Administration's degree from the University of International Business and Economics, Beijing PRC. She also holds a Diploma in Financial Management, jointly issued by The Association of Chartered Certified Accountants (ACCA) and Beijing College for Entrepreneurs.

Sinovac's external auditor continues to be Ernst & Young LLP., which has audited the Company since 2005.

Mr. Weidong Yin, Chairman, President and CEO, stated, "We appreciate Jacob's contributions to the Company and wish Jacob the best in his future endeavors. Nan continues to be a valuable member of the Company's senior management team and has been instrumental in implementing our corporate strategy over the past decade. As the Interim Chief Financial Officer, she will provide for a smooth transition as the Company searches for a new Chief Financial Officer."


Friday, May 13, 2011

Comments & Business Outlook

First Quarter Results:

  • Sales increased 5.3% year-over-year to $4.7 million, compared to $4.4 million. Excluding H1N1 vaccine, sales rose 50% compared to the prior year period.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Following the adjustment to our sales strategy and sales team structure, our sales in China rebounded during the first quarter, which is a positive sign for 2011. We will continuously commit our resources to achieving sales growth."

  • Net loss attributable to shareholders for first quarter of 2011 was $2.8 million, or $0.05 per diluted share, as compared to $307,000, or $0.01 per diluted share, in the same period of 2010.

Thursday, March 3, 2011

Comments & Business Outlook

BEIJING, March 3, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

Sinovac initiated its PCV research program in 2008. The vaccine targets infants under two years old. The target population in China is estimated at 34 million.  The market in China is currently served by only one internationally produced 7-valent pneumococcal conjugate vaccine with three-dose basic vaccination schedule, as no domestic manufacturer has been granted a license to manufacture PCV.  According to the World Health Organization's (WHO) data as of November 2010, over 50 countries have included PCV into their national immunization programs, including the United States, United Kingdom, Australia, Canada and Mexico. Due to the high prices of three PCV vaccines currently globally available, it is cost prohibitive for China and other emerging countries to incorporate this vaccine into their immunization programs. The World Health Organization concluded in March 2011 following an assessment in December 2010 that China's State Food and Drug Administration (SFDA) has been shown to comply with international standards for vaccine regulation. This could eventually open the door for vaccines produced in China to be supplied through United Nations agencies to developing countries.


Monday, January 31, 2011

Comments & Business Outlook

BEIJING, Jan. 31, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today the submission of the applications to commence human clinical trials for its 23-valent and 24-valent pneumococcal polysaccharides vaccines to the Chinese State Food Drug Administration (SFDA) on January 31, 2011. The preclinical studies were completed and showed good safety and efficacy profile in animal models.

Sinovac independently developed the pneumococcal polysaccharides vaccine (PPV) and will retain full commercialization rights to the vaccine upon approval. The supplied quantity of PPV was doubled in China over the past three yearsCdemonstrating the consistent increasing market demand. And the gap between demand and supply in Chinese market still exists. PPV remains relatively expensive in China due to the limited available products. The target population of PPV is children over 2 years old and adults in all age groups, especially the elderly over 65 years old.


Thursday, January 6, 2011

Comments & Business Outlook

 BEIJING,Jan. 6, 2011/PRNewswire-Asia/ -- Sinovac Biotech Ltd. announced today its preliminary unaudited sales range for the fourth quarter and full year endedDecember 31, 2010. A conference call to discuss these preliminary sales will be held onJanuary 6, 2011 at 8:00 a.m. Eastern Standard Time. The Company will issue its final unaudited fourth quarter and full year 2010 financial results on or aboutMarch 31, 2011.

 Sinovac expects its fourth quarter 2010 preliminary unaudited sales to be in the range of approximately $7.8 million to $10.8 million and its full year 2010 preliminary unaudited sales to be in the range of $32 million to $35 million.  The shortfall in sales as compared to the revised total 2010 sales expectations issued in October 2010 was attributable to the weaker than expected sales of Anflu and Healive in the private market. 

 

Dr. Weidong Yin, Chairman & CEO, commented, "We faced a challenging external market environment in 2010, which negatively impacted vaccine demand in the private market. As the company grows, we cannot avoid market-related volatility. We believe it is a great experience for Sinovac's fast-growing management team to learn and grow. Recognizing the importance of addressing this market situation, we are undertaking initiatives to adjust our sales strategy. Concurrently, we are continuing to advance our R&D projects with the aim of completing development and launching our new products. Currently, we have sufficient cash on hand to support Company's R&D activities, capacity expansion, potential M&A and international collaborations, which are the company's driving forces for future growth." 

 

The preliminary sales ranges are preliminary unaudited estimates for the fourth quarter and full year ended December 31, 2010 



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