• | have greater pricing flexibility; |
• | have more extensive research and development and technical capabilities; |
• | have proprietary patent portfolios or other intellectual property rights that may present obstacles to our business; |
• | have greater knowledge of local market conditions where we seek to increase our international sales; |
• | have capability to maintain a competitive management team; or |
• | have investment capability to acquire businesses when the opportunity is not available to us. |
The technologies applied by our competitors and us are rapidly evolving and new developments frequently result in price competition and product obsolescence. In addition, we may be impacted by competition from generic forms of our products, substitute products or imports of products from lower-priced markets. For a detailed description of our competitors, in EV71 vaccine, hepatitis A vaccines, hepatitis A and B vaccines and influenza vaccines, please see “Item 4. Information on the Company — B. Business Overview — Competition.”
We may not be able to maintain market share in China with our commercialized vaccines, which could adversely affect our ability to increase our revenues.
We used to estimate our market share in China based on the batch release number published by the National Institutes for Food and Drug Control or NIFDC,(“NIFDC”) which represents the market share estimated based on published supply quantity, but not the actual number of sales in the market.
We started to market our EV71 vaccine in 2016. We supplied 18.8%10.9%, 20.6% and 52.5%41.8% of the EV71 vaccine market in China in 20172020, 2019 and 2016,2018, respectively.
We supplied 18.0%30.4%, 9.7%26.7% and 16.9%24.3% of the total hepatitis A vaccine market in China, or 75.8%81.8%, 76.3%71.9% and 89.8%67.8% of the inactivated hepatitis A vaccine market in China in 2017, 20162020, 2019 and 2015, respectively, as measured by lot release number. We may not be able to compete with other hepatitis A suppliers for either the private-pay market or public market, which could adversely affect our ability to increase our revenues from hepatitis A vaccine.
We have been marketing and selling seasonal flu vaccines since 2006.2018, respectively. We supplied 12.7%18.6%, 9.9%14.8% and 10.9%nil of the seasonal flu vaccine market in China in 2017, 20162020, 2019 and 2015,2018, respectively. The fluWe supplied 82%, 70.6% and 21.2% of the mumps vaccine market in China is highly competitive.in 2020, 2019 and 2018, respectively. We also launched varicella vaccine in 2020 and supplied 4.1% of varicella in 2020. Our revenue could be adversely impacted if we are not able to maintain our market share in this highly competitive market.
share.
We may not be able to maintain market share in the government-funded hepatitis A vaccine market, or other government-funded vaccine markets, which could adversely affect our revenues, and if we do maintain or expand market share in these markets, we may need to sell our vaccines at a lower price, which could adversely affect our gross margin.
Hepatitis A vaccines have been included in the Expanded Program on Immunization or EPI,(“EPI”) in China since 2007. The PRC government purchases hepatitis A vaccines for each 18-month-old child.
Although the hepatitis A vaccines have been included in the EPI, most provincial and municipal governments are not able to afford the two shots of inactivated hepatitis A vaccines due to insufficient financial support, which constrains the purchase of inactivated hepatitis A vaccines in government-funded markets. Most provincial and municipal governments prefer to purchase lower-priced live attenuated hepatitis A vaccines; however, a few affluent provincial and municipal governments, such as Beijing, Tianjin, Shanghai and Jiangsu province, have started to purchase inactivated hepatitis A vaccines. We are supplying vaccines in these government-funded markets at a lower price than we do in the private market, which could adversely affect our gross margin. Our revenue could also be adversely impacted if we are not able to maintain our market share of the government-funded markets in these cities and provinces. As we are making efforts to breakthrough into additional provincial and municipal public markets, we may be forced to lower our prices to win tenders, which will adversely affect our gross margin.
Since 2007, we have been selected as one of the suppliers by Beijing CDC to supply seasonal influenza vaccines to Beijing citizens. We cannot assure you that we will continue to obtain orders in the future and maintain our market share. If the supply volume continues to decrease,decreases, it would negatively impact our sales revenue in the future.
Since 2008, we have received three stockpiling orders for our H5N1 vaccine from China’s central government every two years in an amount of three million doses per order, and threefour stockpiling orders from Beijing government in an amount of 20,000 doses per order. The latest batch of stockpiled H5N1 vaccines for the central government has expired in the first half of 2016 and we recognized the revenue upon the government inspection. The most recent batch ordered by Beijing government expired in 2020.We cannot assure you that we will receive additional stockpiling orders from governments in the future.
If CDCs, hospitals, physicians and vaccineespatients do not accept our products, we may be unable to generate significant revenue.
Even if we have obtained regulatory approvalapprovals for commercialization of our vaccines in China or in other countries or regions, they still may not gain market acceptance among CDCs, regulatory agencies, hospitals, physicians, vaccineespatients and the medical community, which would limit our ability to generate revenue and adversely affect our results of operations. CDCs, regulatory agencies, hospitals and physicians may not recommend products developed by us or our collaborators until clinical data or other factors demonstrate superior or comparable safety and efficacy of our products as compared to other available treatments. Even if the clinical safety and efficacy of our products are established, CDCs, regulatory agencies, hospitals and physicians may elect not to recommend these products for a variety of reasons. There are other vaccines and treatment options for the conditions that many of our products and product candidates target, such as EV71, hepatitis A and B and influenza. In order to successfully launch a product, we must educate physicians and vaccineespatients about the relative benefits of our products. If our products are not perceived as easy and convenient to use, perceived to present a greater risk of side effects or are not perceived to be as effective as other
available treatments,vaccines, CDCs, hospitals, physicians and vaccineespatients might not adopt our products. A failure of our products to gain commercial acceptance would have a material adverse effect on our business, financial condition and results of operations.
Our business could be negatively affected as a result of actions of shareholders or others.
On March 5, 2018, we announced the re-election of the members of our board of directors—Mr. Weidong Yin, Mr. Yuk Lam Lo, Mr. Simon Anderson, Mr. Kenneth Lee, and Mr. Meng Mei—at our annual general meeting of shareholders held on February 6, 2018 (the “2017 AGM”). We also announced that we had determined, after consultation with our Antigua legal counsel, that an alternative, pre-printed ballot not made available to all our shareholders and purportedly submitted at the 2017 AGM by certain of our shareholders, including 1Globe Capital LLC (“1Globe”), The Chiang Li Family, OrbiMed Advisors LLC and OrbiMed Capital LLC (together “OrbiMed”), and certain additional shareholders (collectively, the “Shareholder Group”) was invalid. We refer to this ballot as the “Non-Public Submission.” On March 13, 2018, 1Globe filed a complaint against Sinovac Antigua in the Eastern Caribbean Supreme Court in the High Court of Justice, Antigua and Barbuda (the “Antigua Court”). The complaint sought a declaration that the five persons purportedly proposed by the Shareholder Group on the Non-Public Submission at the 2017 AGM were elected as directors of Sinovac Antigua at that meeting, an order that those directors be installed as Sinovac Antigua’s board of directors, and a declaration that any actions taken on behalf of Sinovac Antigua at the direction of the board of directors since the 2017 AGM are null and void. Following a trial in early December 2018, the Antigua Court issued a judgment on December 19, 2018 that dismissed 1Globe’s claim and declared that Sinovac Antigua’s shareholder rights agreement (the “Rights Agreement”) was validly adopted as a matter of Antigua law. 1Globe filed notice to appeal the Antigua Court’s judgment on January 29, 2019. 1Globe’s appeal of the Antigua Court’s Judgment was heard on September 18, 2019, and the appeal decision is pending as of the date of this annual report.
On October 8, 2018, Sinovac became aware that unauthorized documents in respect of Sinovac Biotech (Hong Kong) Ltd. (“Sinovac Hong Kong”) had been filed with the Hong Kong Companies Registry to change the directors of Sinovac Hong Kong from Mr. Weidong Yin and Ms. Nan Wang to Mr. Jianzeng Cao and Mr. Pengfei Li. Mr. Yin and Ms. Wang commenced legal proceedings before the High Court of the Hong Kong Special Administrative Region (“Hong Kong High Court”) (“HCMP 1731/2018”). In a hearing before the Hong Kong High Court on October 19, 2018, the judge granted an interlocutory injunction restraining Mr. Li and Mr. Cao from purporting to act or holding themselves out as directors of Sinovac Hong Kong or its subsidiaries, purporting to take any actions as directors of Sinovac Antigua or its subsidiaries, and relying on or using the forged documents in any way whatsoever. On November 28, 2018 at a further hearing in the Hong Kong High Court, the Hong Kong High Court made orders (“November 28 Order”) and held that it is beyond dispute that the documents in respect of Sinovac Hong Kong had been forged and unlawfully filed with the Hong Kong Companies Registry, based on the evidence filed by Mr. Yin and Ms. Wang as Plaintiff, and Mr. Cao and Mr. Li as the Defendants. The Hong Kong High Court therefore declared that Mr. Yin and Ms. Wang were and still are the lawful directors of Sinovac Hong Kong (“Lawful Directors”), and Mr. Li and Mr. Cao were not and are not the lawful directors of Sinovac Hong Kong. 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 Hong Kong or its subsidiaries (including but not limited to Sinovac Biotech Co., Ltd. (“Sinovac Beijing”), purporting to take any actions as directors of Sinovac Hong Kong 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 Hong Kong that had been unlawfully filed. The November 28 Order is effective and enforceable. The Companies Registry has removed the forged documents following the November 28 Order. On November 28, 2018, Mr. Cao and Mr. Li filed a Notice of Appeal with the Hong Kong Court of Appeal, indicating their intention to appeal the orders made by the Hong Kong High Court. The appeal does not operate as a stay on the November 28 Order except to the extent that the Court below, or the Court of Appeal otherwise directs: O.59, r. 13 (1)(a) of the Rules of the High Court. As of the date of this annual report, neither the Court of First Instance nor the Court of Appeal directed that the execution of the November 28 Order should be stayed. So far, Mr. Cao and Mr. Li have taken no further steps in respect of the appeal after the Notice of Appeal was filed on November 28, 2018. No hearing date has yet been fixed to hear the appeal.
On October 8, 2018, Sinovac also became aware that unauthorized documents in respect of Sinovac Beijing had been filed with the Industry and Commerce Bureau of Haidian District of Beijing (“Haidian AIC”) to change the directors of Sinovac Beijing from Mr. Yin, Ms. Wang and Mr. Dawei Mao to Mr. Cao, Mr. Li and Ms. Xiaomin Yang. Mr. Yin and Ms. Wang filed objection to such unlawful change to the Haidian AIC. On March 19, 2020, Haidian AIC issued an official decision (“AIC Decision”) declaring that (i) the unauthorized documents filed are forged and fake documents; (ii) the filing of change of directors with the forged documents is null and void; (iii) the unlawful filing to change the directors will be removed and the registration of Mr. Yin, Ms. Wang and Mr. Mao as directors of Sinovac Beijing will be restored. The parties of material interest concerned in the AIC Decision may raise objection or file a lawsuit within 60 days. No one has filed the objection or lawsuit against the AIC Decision within 60 days thereof.
On May 31, 2019, Heng Ren Investments LP (“Heng Ren”) filed suit against Sinovac and Weidong Yin for alleged breach of fiduciary duties and wrongful equity dilution, in Massachusetts state court. Sinovac removed the matter from state court to the United States District Court for the District of Massachusetts. Heng Ren alleged that Mr. Yin breached fiduciary duties owed to minority shareholders, that Sinovac aided and abetted breaches of fiduciary duties, and that both Sinovac and Mr. Yin engaged in wrongful equity dilution. Heng Ren requested damages, attorneys’ fees, and prejudgment interest. On September 14, 2020, Sinovac filed a motion to dismiss Heng Ren’s claims and the court’s decision on that motion is pending.
We cannot predict the outcome of our ongoing litigation, seeking a determinationincluding whether we will prevail. We also cannot predict how the actionslitigation may affect our stock price, which could be volatile during the pendency of certain shareholders constitute a trigger event undereach suit and following its conclusion. Preparing for the litigation, or any related litigation or related matters, has caused us to incur significant costs and we expect these costs to continue until the litigation concludes. In addition, preparing for litigation is time-consuming and may disrupt our shareholder rights plan, oroperations and divert the attention of management and our employees from
executing our strategic plan. In addition, the uncertainties as to the composition of the board of directors of Sinovac Antigua may materially and adversely affect business in unpredictable ways, which, in turn, could cause our revenue, earnings and operating cash flows to be materially and adversely affected.
The ongoing litigation regarding the Rights Plan,Agreement could have a material adverse effect on the results of our operations and our financial condition.
On March 5, 2018, our companywe filed a lawsuit in the Court of Chancery of the State of Delaware seeking a determination whether certain of our shareholders, including 1Globe Capital LLC, or 1Globe, The Chiang Li Family, OrbiMed Advisors LLC and OrbiMed Capital LLC, or OrbiMed, and certain additional shareholders (collectively, the “Shareholder Group”)Shareholder Group had triggered ourthe Rights Plan,Agreement, by forming a group holding approximately 45% of outstanding shares, in excess of the plan'sRight Agreement’s threshold of 15%, and acting in concert prior to our 2017 annual general meeting of shareholders, or the 2017 AGM. OurThe Rights PlanAgreement is intended to promote the fair and equal treatment of all Sinovac shareholders and ensure that no person or group can gain control of Sinovac through undisclosed voting arrangements, open market accumulation or other tactics potentially disadvantaging the interest of all our shareholders.
On April 12, 2018, 1Globe filed an amended answer to our complaint, counterclaims, and a third-party complaint against Mr. Weidong Yin alleging, among other allegations, that ourthe Rights PlanAgreement is not valid, that Mr. Weidong Yin and the Buyer Consortium (described below), had previously triggered ourthe Rights Plan,Agreement, and that 1Globe did not trigger ourthe Rights Plan.Agreement. The Chiang Li Family and OrbiMed filed similar responses. We, and our board of directors, believe that the actions taken by theour board of directors were appropriate under the circumstances and in the interestinterests of our company and all our shareholders. We also believe that the allegations ofin the counterclaim and third-party complaint are without merit. 1Globe asks for various measures of equitable relief and also includes a claim for its costs, including attorneys’ fees. On March 6, 2019, the Delaware Court entered a status quo order preventing us from distributing Exchange Shares to any shareholders or otherwise take any action pursuant to the Rights Agreement until the conclusion of the Delaware litigation or Court order. The case is stayed pending resolution of parallel litigation in Antigua.
The litigationFollowing a trial on the validity of the Sinovac Antigua’s Rights Agreement, on December 19, 2018, the Antigua Court held that Sinovac Antigua’s Rights Agreement is currentlyvalid under Antigua law, and found that “there was a secret plan to take control of the Company” at the 2017 AGM by the Shareholder Group. On February 18, 2019, after reviewing the Court’s judgment and considering all additional facts known to the Board, the Board determined that the Shareholder Group, together with their affiliates and associates (collectively, the “Collaborating Shareholders”) became Acquiring Persons on or prior to the 2017 AGM and that their conduct resulted in a “Trigger Event” under Sinovac Antigua’s Rights Agreement. Pursuant to the Rights Agreement, our board of directors elected to exchange (the “Exchange”) each valid and outstanding preferred share purchase right held by Sinovac Antigua’s shareholders (not including the Collaborating Shareholders) for a combination of 0.655 of Sinovac Antigua’s common shares and 0.345 of Sinovac Antigua’s newly created Series B Convertible preferred shares (the “Series B Preferred Shares” and, together, each an “Exchange Share”). On February 22, 2019, the Exchange Shares were issued into the Shareholder 2019 Rights Exchange Trust in the pre-trial phase with aname of Wilmington Trust, National Association, which holds the Exchange Shares for the benefit of Sinovac Antigua’s shareholders (not including the Collaborating Shareholders). 1Globe filed notice to appeal the Antigua Court’s judgment on January 29, 2019. On April 4, 2019, the Eastern Caribbean Supreme Court, Court of Appeal issued an order that restrains Sinovac Antigua from taking further action under its Rights Agreement, including the distribution of the previously issued Exchange Shares, until the conclusion of such appeal. 1Globe’s appeal of the Antigua Court’s Judgment was heard on September 18, 2019, and the appeal decision expected beforeis pending as of the enddate of 2018, subject to appeal.this annual report.
The CompanyWe cannot predict the outcome of the litigation, including whether our Rights Plan has been triggered and, if it has been, how the terms of our Rights Plan will be implemented. The Company also cannot predict how the litigation may affect our stock price, which could be volatile during the pendency of the suit and following its conclusion.litigation. Preparing for this litigation, or any related litigation or related matters, has caused the Companyus to incur significant costs and we expect these costs to continue until the litigation concludes. In addition, preparing for this litigation is time-consuming and may disrupt our operations and divert the attention of management and our employees from executing our strategic plan.
Our ongoing litigation against 1Globe and The Chiang Li Family claiming violations of U.S. federal securities laws could have a material adverse effect on the results of our operations and our financial condition.
On March 5, 2018, our companySinovac Antigua filed a lawsuit in the United States District Court for Massachusetts alleging violations of Section 13(d) and Section 13(g) of the Securities Exchange Act of 1934 or the Exchange Act,(the “Exchange Act”) by 1Globe and The Chiang Li Family. The lawsuit alleges, among other things, that the defendant shareholders failed to make required disclosures on Schedule 13D regarding their intentions to attempt to replace our company’sSinovac Antigua’s board of directors.
1Globe counterclaimed to allege violations of securities laws; specifically, abuse of process, negligent misrepresentation, and fraudulent misrepresentation by Sinovac Antigua.
The litigation is currently stayed pending resolution of the parallel litigation in the pre-trial phaseAntigua, and the Companywe cannot predict when or how the litigation will be resolved. There can be no assurance that our companywe will prevail in this litigation. Preparing for this litigation, or any related litigation or related matters may result in significant costs to our company or otherwise adversely affect our business.
Our business could be negatively affected as a result of actions of shareholders or others.
On March 5, 2018, we announced the re-election of the members of our board of directors—Mr. Weidong Yin, Mr. Yuk Lam Lo, Mr. Simon Anderson, Mr. Kenneth Lee, and Mr. Meng Mei—at the 2017 AGM held on February 6, 2018. We also announced that we had determined, after consultation with our Antigua legal counsel, that an alternative, pre-printed ballot not made available to all our shareholders and purportedly submitted at our 2017 AGM by the Shareholder Group was invalid. We refer to this ballot as the “Non-Public Submission.”
On March 13, 2018, 1Globe filed a complaint against our company in the Eastern Caribbean Supreme Court in the High Court of Justice, Antigua and Barbuda, or the Antigua Court. The complaint seeks a declaration that the five persons purportedly proposed by the Shareholder Group on the Non-Public Submission at the 2017 AGM were elected as directors of our company at that meeting, an order of the Antigua Court that those directors be installed as our company’s board of directors, and a declaration that any actions taken on behalf of our company at the direction of the board of directors since the 2017 AGM are null and void. On April 10, 2018, 1Globe filed a notice of application in the Antigua Court seeking an order declaring the result of the disputed election, an urgent order restraining our board of directors from acting, pending determination of the dispute, including acting to initiate or continue litigation against the Shareholder Group, and other related relief. Hearings in this litigation are scheduled for May 9 and May 18, 2018.
The Company cannot predict the outcome of the litigation, including whether the Company will prevail. The Company also cannot predict how the litigation may affect our stock price, which could be volatile during the pendency of the suit and following its conclusion. Preparing for this litigation, or any related litigation or related matters, has caused the Company to incur significant costs and we expect these costs to continue until the litigation concludes. In addition, preparing for this litigation is time-consuming and may disrupt our operations and divert the attention of management and our employees from executing our strategic plan. In addition, the uncertainties as to the composition of our board of directors, may materially and adversely affect business in unpredictable ways, which, in turn, could cause our revenue, earnings and operating cash flows to be materially and adversely affected.
Disruptive actions taken by the minority shareholder of Sinovac Biotech Co., Ltd., or Sinovac Beijing caused suspension of production, destruction of products and disruption of our website, which may materially and adversely affect our business, financial condition and results of operations.
Sinovac Beijing, our principal operating subsidiary, is a Sino-foreign equity joint venture in which we own a 73.09% interest and Sinobioway Bio-medicine Co., Ltd. (formerly, formerly named Xiamen Bioway Group Co., Ltd), or Ltd (“Sinobioway Medicine,Medicine”), owns a 26.91% interest. Recent events suggest that Sinobioway Medicine’s interests are not aligned with our interests. We cannot assure you that Sinobioway Medicine will be cooperative with us in handling matters related to the operations of Sinovac Beijing.
As the minority shareholder of Sinovac Beijing, according to Sinovac Beijing’s articles of association, Sinobioway Medicine has the right to assign a director to the five-director board of Sinovac Beijing. Mr. Aihua Pan,Beijing, and the Chairman of the board of Sinovac Beijing,director assigned by Sinobioway Medicine is the currentlegal representative of Sinobioway Medicine on the board of Sinovac Beijing. Accordingly, the representative of Sinobioway Medicine has the ability to take actions that bind Sinovac Beijing or to block any action that requires unanimous board approval. In addition, if we wish to transfer our equity interest in Sinovac Beijing, in whole or in part, to a third party, Sinobioway Medicine has a right of first refusal to purchase our interest in accordance with relevant PRC regulations.
Sinobioway Medicine, the minority shareholder of Sinovac Beijing, has additional rights under the joint venture contract and articles of association of Sinovac Beijing. The joint venture contract and articles of association require the consent of each of Sinovac Beijing’s shareholders and/or unanimous board approval on matters such as a major change in the business line of the company, expansion or amendment of the business scope of the company, transfer of the registered capital by a shareholder, creation of a mortgage or pledge upon the company’s assets, a change in the organizational form of the company and designation or removal of the general manager.
In February 2018, Mr. Aihua Pan, the representative of Sinobioway Medicine, sent letters without the approval of the full board of Sinovac Beijing, to Mr. Weidong Yin, Ms. Nan Wang, and other senior managers of Sinovac Beijing purporting to terminate their employment. The board of directors of Sinovac Beijing subsequently determined, with the advice of PRC legal counsel, that this action did not conform with the joint venture contract and articles of association and was unlawful. On March 5, 2018, Sinovac Biotech announced actions taken to enhance the corporate governance and management of Sinovac Beijing, including the appointment of Mr. Dawei Mao, Chairman of Zhongke Biopharmaceutical Co., Ltd., as a director of Sinovac Beijing. He replaced Ms. Xiaomin Yang, the current President of Sinobioway Group Co., Ltd. In addition, in March 2018, Mr. Weidong Yin, Ms. Nan Wang, and other senior managers of Sinovac Beijing signed new employment agreements with Sinovac Biotech Ltd. and Sinovac Beijing.
On April 17, 2018, Mr. Aihua Pan and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and limited the physical movements of employees in Sinovac Beijing’s general manager’s office and finance department in an attempt to wrongfully take control of Sinovac Beijing’s official seal, legal documents, accounting seal, financial documents and financial information systems. In addition, these individuals disrupted Sinovac Beijing’s hepatitis A vaccine production and seasonal flu vaccine production by cutting power, seriously impacting Sinovac Beijing’s production and manufacturing processes and possibly damaging product quality. Due to thethese disruptive actions, of the representative of Sinobioway Medicine, Sinovac Beijing was forced to destroy the affected products. To maintain product safety, Sinovac Beijing temporarily suspended production at the impacted facility, and will continue to take every action to eliminate any biological safety risks due to the power outage.though production has resumed at this facility months later. Sinovac Beijing was also forced to destroy the bacterial seeds intended for use in the production of its 23-valent pneumococcal polysaccharide vaccine or PPV,(“PPV”) and to suspend all preparations for and ultimately postpone the inspection by NMPA, formerly known as the PRC State Food and Drug Administration, or CFDA, inspection of the manufacturing site necessary for 23-valent PPV production approval.
On September 17, 2020, the Fourth Intermediate People’s Court of Beijing issued a judgment holding Sinobioway Medicine and Mr. Aihua Pan liable for torts and breaches of shareholders fiduciary duty under the PRC Company Law and liable for Sinovac Beijing’s losses of RMB 15.4 million caused by their disruptive actions. Sinovac Beijing, Sinobioway Medicine and Mr. Aihua Pan filed notice to appeal to the Higher People’s Court of Beijing Municipality.
These and other actions taken by the representative of Sinobioway Medicine may materially and adversely affect our business, financial condition and results of operations. We also cannot assure you that the representative of Sinobioway Medicine will cease from interfering with our business.
We do not currently intend to hold an annual general meeting of shareholders until after the final determination of the litigation concerning the Rights Agreement, which will delay the ability of our shareholders to vote in an election of our directors.
With the ongoing litigations concerning the Exchange and the Rights Agreement, we have not been able to hold an annual meeting of shareholders since February 2018, and will not be able to hold an annual meeting of shareholders before the final determination of such litigations. Therefore, our shareholders will not have the opportunity to vote in an election of our directors for an indeterminate amount of time. If our shareholders want us to hold an annual meeting prior to the final determination of these ongoing litigations, they may attempt to force us to hold one under Antigua law.
We may not achieve the expected return on our investment in Sinovac (Dalian) Vaccine Technology Co., Ltd., or (“Sinovac Dalian.
Dalian”).
In November 2009, we entered into an agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, we established Sinovac Dalian to focus on the research, development, manufacturing and commercialization of vaccines, such as mumps and varicella for human use. Pursuant to the joint venture agreement, we made an initial cash contribution of RMB60.0 million ($9.39.2 million) in exchange for a 30% equity interest in Sinovac Dalian, and Dalian Jin Gang Group made an asset contribution of RMB140.0 million ($21.621.5 million), including the manufacturing facilities, production lines and land use rights, in exchange for the remaining 70% interest in Sinovac Dalian. In December 2010, we purchased an additional 25% equity interest in Sinovac Dalian from Dalian Jin Gang Group for consideration of RMB50.0 million ($7.7 million). In October 2016, we increased our ownership in Sinovac Dalian to 67.86% by making an additional RMB80.0 million ($12.812.3 million) capital contribution. In November 2020, we increased our ownership in Sinovac Dalian to 68% by converting RMB46.6 million ($7.0 million) loan into capital. In 2020, 2019 and 2018, we provided a loan of RMB17 million ($2.6 million), RMB30 million ($4.6 million) and RMB30 million ($4.6 million), respectively, to Sinovac Dalian. We cannot assure you that Sinovac Dalian’s business, covering the research, development, manufacturing and commercialization of vaccines, such as mumps and varicella, will be successful. As such, we could incur related impairment charges in the future. Any failure to achieve the expected return on our investment in Sinovac Dalian may materially and adversely affect our business, financial condition and results of operations.
The interests of the minority shareholder of Sinovac Beijing, Sinovac Life Sciences Co., Ltd. (“Sinovac LS”, formerly known as Sinovac Research and Development Co., Ltd.) and Sinovac Dalian may diverge from our own, which may adversely affect our ability to manage these subsidiaries.
Under China’s joint venture regulations,We are the unanimous approvalmajority shareholder of members of a joint venture’s board of directors who are present at a board meeting is required for any amendment to the joint venture’s articles of association, the termination or dissolution of the joint venture company, an increase or decreaseand have equity interests in the registered capital of the joint venture company or a merger or de-merger of the joint venture.Sinovac Beijing, Sinovac LS and Sinovac Dalian. If our interests diverge from those of our minority shareholders, they may exercise their rights under the relevant articles of association, shareholder’s agreement or joint venture contracts of each of such subsidiaries and the relevant PRC laws to protect their own interests, which may be adverse tosubstantially differ from ours. As a result, our ability to manage these subsidiaries may be adversely affected, which in turn may materially and adversely affect our business, financial condition and results of operations.
Recent disruptive actions taken by Sinobioway Medicine suggesthas shown that its interests are not aligned with our interests.ours. We cannot assure you that Sinobioway Medicine will be cooperative with us in handling matters related to the operations of Sinovac Beijing. ToBeijing in the future.
As of the date of this annual report, Dalian Jin Gang Group has been cooperativecooperating with us in handling matters with respect to the business of Sinovac Dalian.Dalian, and the minority shareholders of Sinovac LS have been aligned with us with respect to the business of Sinovac LS. We cannot assure, you, however, that Dalian Jin Gang Groupthese minority shareholders will continue to act in a cooperative manner in the future.
Our growth may be adversely affected if market demand for our vaccine products and product candidates does not meet our expectations. We may encounter problems of inadequate supply or oversupply, which would materially and adversely affect our financial condition and results of operations and would also damage our reputation and brand.
The production of vaccine products is a lengthy and complex process. As a result, our inability to match our production to market demand may result in a failure to meet market demand, which could materially and adversely affect our financial condition and results of operations and could also damage our reputation and corporate brand. For example, many vaccineespatients receive their seasonal flu vaccinations in the three-month period from September to November in anticipation of an upcoming flu season and we expect this period to be one of the most significant sales periods for this product each year. In anticipation of the flu season, we intend to build up inventory of our Anflu product in line with what we believe will be the anticipated demand for the product. If actual demand does not meet our expectations, we may be required to write off significant inventory and may otherwise experience adverse consequences in our financial condition. If we overestimate demand, we may purchase more raw materials than required. If we underestimate demand, our third-party suppliers may have inadequate raw material inventories, which could interrupt our manufacturing, delay shipments and result in lost sales.
If we are unable to enroll sufficient vaccineessubjects and identify clinical investigators for our clinical trials, our development programs could be delayed or terminated.
The rate of completion of our clinical trials significantly depends on the rate of enrollment of volunteers. VaccineesPatients enrollment is a function of many factors, including:
• | efforts of the sponsor and clinical sites involved to facilitate timely enrollment; |
• | patient referral practices of physicians; |
• | design of the protocol; |
• | eligibility criteria for the study in question; |
• | perceived risks and benefits of the drug under study; |
• | the size of the |
• | availability of competing therapies; |
• | availability of clinical trial sites; and |
• | proximity of and access by |
We may have difficulty in obtaining sufficient volunteer subjects enrollment or finding qualified investigators to conduct ourthe clinical trials as planned and we may need to expend substantial funds to obtain access to resources or delay or modify our plans significantly. These considerations may lead us to consider the termination of development of a product for a particular indication.
A setback in any of our clinical trials could adversely affect our share price.
Clinical trials are an important part of vaccine research before any vaccine is approved for commercial use in humans. Setbacks in any phase of the clinical trials of our product candidates could have a material adverse effect on our business and our prospects and financial results and would
likely cause a decline in the price of our common shares. We may not achieve our projected development goals in the time frames we announce and expect. If we fail to achieve one or more milestones as contemplated, the market price of our common shares could decline.
We set goals for, and make public statements regarding, our anticipated timing of the accomplishment of objectives material to our success, such as the commencement and completion of clinical trials and other milestones. The actual timing of these events can vary significantly due to factors such as delays or failures in our clinical trials, the uncertainties inherent in the regulatory approval process and delays in achieving manufacturing or marketing arrangements sufficient to commercialize our products. We may not complete our clinical trials or make regulatory submissions or receive regulatory approvals as planned. Also, we may not be able to adhere to our anticipated schedule for the launch of any of our products. If we fail to achieve one or more milestones as contemplated, the market price of our shares could decline. We obtained the approval to conduct clinical trials for our Sabin inactivated polio vaccine, or sIPV, in December 2015 and phase I and II trials were completed in April 2017. The phase III trial was commenced in August 2017 and is expected to be completed in the second quarter of 2018.
We rely on third parties to conduct clinical trials, who may not perform their duties satisfactorily.
After we obtain approval to conduct clinical trials for our product candidates, we rely on qualified research organizations, medical institutions and clinical investigators to enroll qualified vaccineespatients and conduct clinical trials. Our reliance on these third parties for clinical development activities reduces our control over the clinical trial process. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not fulfill their contractual obligations, including failing to meet expected deadlines, we may not succeed or may experience delays in our efforts to obtain regulatory approvals and commercialize our vaccine candidates.
If any of our third-party suppliers or manufacturers cannot adequately meet our needs, our business could be harmed.
While we use raw materials and other key material supplies that are generally available from multiple commercial sources, certain raw materials that we use to cultivate our influenza vaccines, such as embryonated eggs, are in short supply or difficult for suppliers to produce in accordance with our specifications.specifications If third-party suppliers were to cease production or otherwise fail to supply us with quality raw materials, and if we were unable to contract on acceptable terms for these materials with alternative suppliers, our ability to deliver our products to the market would be adversely affected.
In addition, if we fail to secure long-term supply sources for some of the raw materials we use, our business could be harmed. For example, we do not have a long-term agreement for the supply of hepatitis B antigens used for Bilive production. We sourcesourced hepatitis B antigens entirely from Beijing Tiantan Biological Products Co., Ltd., or (“Beijing Tiantan.Tiantan”) for Bilive production. Although we are developing our own hepatitis B vaccine, before it is approved to be commercialized, we have to rely on the supplier to receive hepatitis B antigen.We and Beijing Tiantan agreed to enter into annual hepatitis B antigens supply agreements after our previous ten-year exclusive supply framework agreement expired in October 2012. Beijing Tiantan supplied hepatitis B antigens to us from July 2013 to June 2015 based on the annual supply agreement. Thereafter, Beijing Tiantan ceased its hepatitis B antigens production due to facilities renovation until 2018. To ensure sufficient storage, we procured an abundant amount of hepatitis B antigens fromrenovation. We will work closely with Beijing Tiantan and produced a significant amountto resume production of Bilive in 2015. Beijing Tiantan could delay its renovation schedule and ceaseBilive. However, we do not have expected timetable to supply us with hepatitis B antigens in the future, in which case our business, financial condition and results of operations may be materially and adversely affected.
this.
From time to time, concerns are raised with respect to potential contamination of biological materials supplied to us. These concerns can tighten market conditions for materials that may be in short supply or available from limited sources. Moreover, regulatory approvals to market our products may be conditioned upon obtaining certain materials from specified sources. Any efforts to substitute material from an alternate source may be delayed by pending regulatory approval of such alternate source. Although we work to mitigate the risks associated with relying on sole suppliers, material shortages could impact product development and production.
Our business is highly seasonal. This seasonality will contribute to our operating results fluctuating considerably throughout the year.
The seasonality in our business is expected to result in significant quarterly fluctuations in our ongoing operating results. For example, the influenza season generally runs from November through March of the next year and the largest percentage of influenza vaccinations is administered between September and November of each year. As a result, we expect to realize most of our annual revenues from Anflu during this period.
We rely on a limited number of facilities for the manufacturing of our products in accordance with relevant regulatory requirements. Any disruption to our existing manufacturing facilities or in the development of new facilities could reduce or restrict our sales and harm our reputation.
According to the China GMP guidelines, each vaccine product can only be produced in a dedicated production facility. In Beijing, we conduct the primary production of each vaccine in a dedicated production plant at our Shangdi site, or Changping site and Daxing Site, and secondary filling and packaging at our Changping site. In Dalian, we manufacture mumps and varicella vaccine at one facility. We do not maintain back-up facilities for our currently available products, so we are dependent on our existing facilities for the continued operation of our business.
As described more fully above, a representative of Sinobioway Medicine, who iswas the Chairman of the board of directors of Sinovac Beijing, and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and disrupted Sinovac Beijing’s hepatitis A vaccine production and seasonal flu vaccine production by cutting power to our Shangdi site, seriously impacting Sinovac Beijing’s production and manufacturing processes and possibly damaging product quality. Due to the actions of the representative of Sinobioway Medicine, Sinovac Beijing was forced to destroy the affected products. To maintain product safety, Sinovac Beijing temporarily decided to stop production at the impacted facility, and will continue to take every action to eliminate any biological safety risks due to the power outage.though production has resumed at this facility months later.
Natural disasters or other unanticipated catastrophic events, including power interruptions, water shortages, storms, fires, earthquakes and terrorist attacks, could significantly impair our ability to manufacture our products and operate our business and could also delay our research and development activities. Our facilities and certain equipment located in these facilities would be difficult to replace and could require substantial replacement lead-time. Catastrophic events may also destroy any inventory located in our facilities.
We do not maintain any business interruption insurance to cover lost income as a result of any such events. The occurrence of such events could materially and adversely affect our business. We may build additional manufacturing facilities in the future. There can be no assurance, however, that we will be able to expand our manufacturing capabilities to or realize the anticipated benefits of our new facilities. Any of these factors could reduce or restrict our sales, harm our reputation and have a material adverse effect on our business, financial condition, results of operations and prospects.
We willmay need additional capital to upgrade the production plant for our existing products or expand the facility,our production capabilities, to continue development of our product pipeline and to market existing and future products on a large scale. We cannot guarantee that we will find adequate sources of capital in the future.
We closed a public offering of our common shares on February 2, 2010, and received net proceeds of approximately $61.8 million, after deducting underwriting discounts and commissions and offering expenses payable by us. We have invested approximately $29.2 million in incorporation of Sinovac Dalian and invested $26.8 million in Sinovac Research & Development Co., Ltd. or Sinovac R&D to conduct research and development and other operating activities of operational entities in PRC. We have used the remaining net proceeds from the offering for the research and development of our product candidates and other general corporate purposes.
In the long run,future, we willmay need to raise additional funds to finance equipment expenditures, to acquire intellectual property, to further expand the production facility for our pipeline products, to continue the development and commercialization of our product candidates and to fund other corporate purposes. As of December 31, 2017,2020, we had approximately $114.4$1,041 million in cash and cash equivalents. We expect to undertake significant future financings in order to:
• | establish and expand manufacturing capabilities; |
• | proceed with the research and development of other vaccine products, including clinical trials of new products; |
• | commercialize our products, including the marketing and distribution of new and existing products; |
• | seek and obtain regulatory approvals; |
• | develop or acquire directly, or indirectly through acquisition of companies, other product candidates or technologies or companies; |
• | protect our intellectual property; and |
• | finance general, administrative and research activities that are not related to specific products under development. |
In the past, we funded most of our research and development and other expenditures through government grants, working capital, bank loans and proceeds from private placements and public offerings of our common shares. We may raise additional funds in the future because our current operating and capital resources may be insufficient to meet future requirements.
Sinovac Antigua is authorized to issue 100,000,000 common shares, 99,294,743 of which are issued and outstanding.To increase the number of authorized common shares, we must amend Sinovac Antigua’s Articles of Incorporation and By-laws, which requires (i) the majority of common shares be present for a quorum, and (ii) affirmative vote of two thirds of common shares (excluding Series B Preferred Shares) present and voting at the general meeting. We cannot assure that Sinovac Antigua will be able to collect sufficient affirmative votes to amend its Articles of Incorporation and By-laws. If we fail to increase the number of authorized commons shares of Sinovac Antigua, we will lack common shares for future issuance of equity securities.
If we raise additional funds by issuing equity securities, it will result in further dilution to our existing shareholders because the shares may be sold when the market price is low and shares issued in equity financing transactions will normally be sold at a discount to the current market price. Any additional equity securities issued also may provide for rights, preferences or privileges senior or otherwise preferential to those of holders of our existing common shares. Unforeseen problems including materially negative developments relating to, among other things, disease developments, product sales, new product rollouts, clinical trials, research and development programs, our strategic relationships, our intellectual property, litigation, regulatory changes in our industry, the Chinese market generally or general economic conditions, could interfere with our ability to raise additional funds or materially and adversely affect the terms upon which such funding is available.
If we raise additional funds by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of holders of our common shares, and the terms of the debt securities issued could impose significant restrictions on our operations. If we raise additional funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to certain of our technologies, marketing territories, product candidates or products that we would otherwise seek to develop or commercialize ourselves, or be required to grant licenses on terms that are not favorable to us. In the past, we have received different types of grants from the PRC government to finance the research and development and facility investment of our vaccine products. We may not receive additional grants in the future.
As described above, the actions of the Shareholder Group leading up to and at ourthe 2017 AGM resulted in uncertainties as to the future direction of our company and the composition of our board of directors. As a result of these uncertainties, we do not know whether additional financing will be available to us on commercially acceptable terms when needed. If adequate funds are not available or are not available on commercially
acceptable terms, we may be unable to continue developing our products. In any such event, our ability to bring a product to market and obtain revenues could be delayed and competitors could develop products sooner than we do. As a result, our business, financial condition and results of operations could be materially and adversely affected.
We issued approximately 27.8 million common shares and 14.6 million Series B Preferred Shares in connection with the Exchange, and could issue additional common shares or Series B Preferred Shares, or one or more additional series of preferred shares with the effect of diluting existing shareholders and impairing their voting and other rights
Our articles of incorporation authorize the issuance of up to 100,000,000 common shares and 50,000,000 preferred shares with designations, rights, privileges, restrictions and conditions as may be determined from time to time by our board of directors. On February 22, 2019, in connection with the Exchange, we issued approximately 27.8 million common shares and 14.6 million Series B Preferred Shares for the benefit of the holders of valid and outstanding Rights as of that date. This issuance had the effect of significantly diluting the holdings of the shareholders that are not entitled to participate in the Exchange.
The Series B Preferred Shares share equally in all dividends and distributions made on our 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 our option, or automatically upon a successful shareholder vote to increase the authorized number of Sinovac Antigua’s common shares. 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. As a result of the ongoing litigation described elsewhere, there can be no assurance that this preferred share dividend will be paid in a timely manner, if at all.
Our board is empowered, without shareholder approval, to issue one or more additional series of preferred shares with dividend, liquidation, conversion, voting or other rights which could dilute the interest of, or impair the voting power of, our common shareholders. The issuance of such additional series of preferred shares, or the issuance of additional common shares, could be used as a method of discouraging, delaying or preventing a change in control.
The PIPE Investors (as defined below) may exercise influence over us, including through their ability to influence matters requiring the approval of holders of our Common Stock or Series A Preferred Stock.
On July 2, 2018, we completed a private placement of our common shares (the “PIPE”) with private investors Vivo Capital and Advantech Capital (the “PIPE Investors”), whereby we received gross proceeds of $86.73 million. The proceeds of this offering will be used to increase our capabilities in research relating to quality control and to build additional production facilities to support the development and commercialization of sabin inactivated polio vaccine (“sIPV”) -based combination vaccine and other new vaccine projects. These investments have not yet been made due in part to the disruptive actions of certain of our shareholders and the related litigation, which remains ongoing.
The shares owned by the PIPE Investors currently represent approximately 20.72% of the voting rights in respect of our share capital (after taking into account the shares issued in the Exchange under the Rights Agreement). Further, the PIPE Investors are entitled to appoint a designee and observer to Sinovac Antigua’s board of directors. Accordingly, the PIPE Investors may have the ability to influence the direction of Sinovac Antigua or the outcome of most matters submitted for the vote of our shareholders. In any of these matters, the interests of the PIPE Investors may differ from or conflict with the interests of our other shareholders.
In connection with the PIPE, Sinovac Antigua entered into a shareholders agreement with the PIPE Investors, pursuant to which the PIPE Investors agreed to vote their shares affirmatively in favor of all of the director designees nominated to serve on Sinovac Antigua’s board of directors, and the PIPE Investors agreed to transfer restrictions with respect to their shares and a standstill provision, which, among other things, bars each PIPE Investor and its affiliates from acquiring in excess of 10% of the share capital of Sinovac Antigua.
In addition, the PIPE Investors are in the business of making investments in companies and may, from time to time, acquire interests in businesses that directly or indirectly compete with our business, as well as businesses that are significant existing or potential customers.
If we are unable to attract, train, retain and motivate our direct sales force and third-party marketing agents, sales of our products may be materially and adversely affected.
We rely on our direct sales force and third-party marketing agents, who are dispersed across China, to market our products to CDCs and other healthcare institutions. We believe that our future success will depend on the dedication, efforts and performance of our direct sales force and third-party marketing agents. There are only limited numbers of competent and qualified marketing agents in the China vaccine industry. Our competitors may provide commissions or other economic incentives to third-party marketing agents significantly above the market standard, which may cause such agents to cease marketing our products. If we are unable to attract, train, retain and motivate our direct sales force and marketing agents, sales of our products may be materially and adversely affected.
Anti-corruption measures taken by the PRC government to correct corruptive practices in the vaccine industry could adversely affect our sales and reputation.
The PRC government has taken anti-corruption measures to correct corrupt practices. In the vaccine industry, such practices include, among others, acceptance of kickbacks, bribery or other illegal gains or benefits by the officials of CDCs in connection with the prescriptionrecommendation of a certain vaccine. We do not control the business activities of our third-party marketing agents, who maymight engage in corrupt practices to promote our products.products, which may be unknown to us. While we maintain strict anti-corruption policies applicable to our internal sales force and third-party marketing agents, these policies may not be completely effective. If any individual of our sales staff or any of our third-party marketing agents engageengages in suchcorrupt practices and the PRC government takes enforcement action, our products may be seized and our own practices and involvement in the market agents’ practices may be checked or investigated. If this occurs, our sales and reputation may be materially and adversely affected.
Some of the predecessor shareholders of Sinovac Beijing were enterprises owning state-owned assets or EOSAs.(“EOSAs”). Their failures to comply with PRC legal requirements in asset or share transfers could, under certain circumstances, result in such transfers being invalidated by government authorities. If this occurs, we could lose our ownership of intellectual property rights that are vital to our business as well as our equity ownership in Sinovac Beijing.
Sinovac Beijing is currently owned 73.09% by us and 26.91% by Sinobioway Medicine (formerly named Xiamen Bioway Group Co., Ltd).Medicine. The technologies related to our hepatitis A vaccine, hepatitis A and B vaccine and influenza vaccine that are vital to our business were directly or indirectly transferred to us by Tangshan Yian Biological Engineering Co., Ltd., or (“Tangshan Yian.Yian”). Some of the predecessor shareholders of Sinovac Beijing, including Shenzhen Kexing Biological Engineering Ltd., or (“Shenzhen Kexing,Kexing”), Sinobioway Medicine, Tangshan Medicine Biotech Co., Ltd., Tangshan Yikang Biotech Co., Ltd. and Tangshan Yian, were EOSAs.
Under applicable PRC laws, when EOSAs sell, transfer or assign assets or equity investments in their possession or under their control to third parties, they are required to obtain an independent appraisal of the transferred assets or shares and file such appraisal with or obtain approval of such appraisal from PRC government authorities. Since 2004, EOSAs have also been required to make such assets or equity transfers at government-designated marketplaces. Certain of our acquisitions of intellectual property rights and some equity interests were subject to these requirements.
Tangshan Yian failed to file with the government authorities the appraisal of the hepatitis A vaccine technology that it transferred to Sinovac Beijing in 2001 as its capital contribution to Sinovac Beijing. Under PRC laws, Tangshan Yian also failed to:
• | obtain the appraisal of the hepatitis A and B vaccine technology that it transferred for no consideration to Beijing Keding Investment Co., Ltd. |
• | obtain the appraisal of the influenza vaccine technology that it transferred to Sinovac Beijing in 2004 and to file such appraisal with the government authorities. |
These failures subject us to the risk of losing ownership or control of these vaccine technologies.
In addition, before we acquired our 73.09% equity interest in Sinovac Beijing, it had undergone multiple changes in its shareholders and the amounts held by the same.its shareholders. Some of the EOSA shareholders of Sinovac Beijing have sold, transferred or assigned their respective equity interests in Sinovac Beijing without fully complying with laws to appraise the equity interests, to file such appraisals with or obtain regulatory approval of such appraisals from PRC government authorities or to make equity interest transfers at the government-designated marketplaces as required for transactions completed after 2004. Similar to the asset transfers, such failures subject us to the risk of losing the ownership or control of our equity interest in Sinovac Beijing.
PRC government authorities may take court actions to invalidate the transfers of the assets or equity investments discussed above for non-compliance with applicable appraisal, filing, approval and designated marketplace requirements. The government authorities could take such legal actions and such legal actions, if commenced, could be successful. If these transfers are invalidated, we would lose title to these assets and investments. Because we depend on these technologies and because Sinovac Beijing constitutes core part of our operations, our loss of these technologies or equity interest in Sinovac Beijing would materially and adversely affect our operations and financial condition.
There can be no assurance that the going private transaction will be successfully consummated. Potential uncertainty involving the going private transaction may adversely affect our business and the market price of our common shares, and we are restricted from soliciting or, subject to certain exceptions, engaging in negotiations with third parties regarding competing proposals.
On June 26, 2017, we entered into a definitive amalgamation agreement, or the AmalgamationThe Rights Agreement with Sinovac (Cayman) Limited, or Parent, and Sinovac Amalgamation Sub Limited, or Amalgamation Sub, a wholly owned subsidiary of Parent. On March 26, 2018, we amended the Amalgamation Agreement to extend its termination date to April 26, 2018. On April 26, 2018, we further amended the Amalgamation Agreement to extend its termination date to May 26, 2018. Pursuant to the Amalgamation Agreement, Parent will acquire Sinovac Biotech Ltd. for cash consideration equal to $7.00 per common share. 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 Sinovac Biotech Ltd., with Sinovac Biotech Ltd. continuing as the surviving corporation and a wholly owned subsidiary of Parent, or the Amalgamation. Our board of directors, acting upon the unanimous recommendation of the special committee formed by the board of directors, or the Special Committee, unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that our shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation. Immediately following the consummation of the transaction contemplated by the Amalgamation Agreement, Parent would be beneficially owned by a consortium, or the Buyer Consortium, comprising Mr. Weidong Yin, our chairman, president and chief executive officer, SAIF partners IV L.P., or SAIF, C-Bridge Healthcare Fund II, L.P., Advantech Capital L.P., Vivo Capital Fund VIII, L.P. and Vivo Capital Surplus Fund VIII, L.P.
The Amalgamation is subject to customary closing conditions, including approval by an affirmative vote of holders of our common 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 our 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. If completed, the Amalgamation will result in Sinovac Biotech Ltd. becoming a privately-held company and our common shares will no longer be listed on NASDAQ. The going private transaction, whether or not consummated, presents a risk of diverting management focus, employee attention and resources from other strategic opportunities and from operational matters. Potential uncertainty involving the going private transaction may adversely affect our business and the market price of our common shares.
In addition, the Amalgamation Agreement restricts our ability, until the effective time of the Amalgamation or, if earlier, the extended termination of the Amalgamation Agreement, to solicit or, subject to certain exceptions, engage in discussions or negotiations with third parties regarding certain competing proposals or transactions as described in the Amalgamation Agreement, and if the Amalgamation Agreement is terminated under certain circumstances, we may be required to pay Parent a termination fee of $15.0 million.
Our Rights Plan and certain provisions of our By-laws may discourage a change of control.
In March 2016, we adopted ourthe Rights PlanAgreement that provides for the issuance of one right or the Right,(a “Right”) for each of our outstanding common shares. We amended and restated the Rights Agreement in February 2019 that provides for the issuance of one Right for each of our outstanding common shares and Series B Preferred Shares. In February 2020, we further amended the amended and restated Rights Plan twiceAgreement to extend its term for an additional 12-month period in March 2017 and again amended it to extend its term for an additional 12-month period in March 2018.until February 2021. The Rights are designed to assure that all of our shareholders receive fair and equal treatment in the event of any proposed takeover and to guard against partial tender offers, open market accumulations, undisclosed voting arrangements and other abusive or coercive tactics to gain control of our company or our board of directors without paying all shareholders a control premium. The Rights will cause substantial dilution to a person or group that acquires 15% or more of the aggregate total of common shares and Series B Preferred Shares on terms not approved by our board of directors. In June 2017, we amended our Rights Plan in connection with the execution of the Amalgamation Agreement.
As described above, 1Globe seeks a determination byis appealing the Court of Chanceryjudgment of the State of DelawareAntigua Court that ourthe Rights PlanAgreement is invalid.valid. If 1Globe is successful, our shareholders will not benefit from the protections of ourthe Rights PlanAgreement and our company may be subject to abusive or coercive tactics by
certain shareholders to gain control of our company or our board of directors without paying all shareholders a control premium. On April 4, 2019, the Eastern Caribbean Supreme Court, Court of Appeal issued an order that restrains our company from taking further action under the Rights Agreement, including the distribution of the previously issued Exchange Shares, until the conclusion of such appeal. The appeal decision is pending as of the date of this annual report.
On February 21, 2021, we entered into a second amendment to the Rights Agreement to extend the expiration date of the rights contained therein from February 22, 2021 to February 22, 2022.
Some provisions of our By-laws may discourage, delay or prevent a change in control of our company or management that shareholders may consider favorable, including provisions that authorize our board of directors to issue preferred shares in one or more series and to designate the price, rights, preferences, privileges and restrictions of such preferred shares without any further vote or action by our shareholders.
These provisions could make it more difficult for a third party to acquire us, even if the third party’s offer may be considered beneficial by many shareholders. As a result, shareholders may be limited in their ability to obtain a premium for their shares.
We depend on our key personnel, the loss of whom would adversely affect our operations. If we fail to attract and retain the talent required for our business, our business will be materially harmed.
We are a small company with 644had 1959 full-time employees as of December 31, 20172020 and we depend to a great extent on principal members of our management and scientific teams. If we lose the services of any key personnel, in particular Mr. Weidong Yin, the loss could significantly impede the key decision making on strategic choices and operational issues, which in turn will harm our business achievement. We do not have any key man life insurance policies. We have entered into employment agreements with our executive officers, under which they have agreed to restrictive covenants relating to non-competition and non-solicitation. These employment agreements do not, however, guarantee that we will be able to retain the services of all our executive officers in the future.
As described above, a representative of Sinobioway Medicine, who iswas the Chairman of the board of directors of Sinovac Beijing, sent letters without the approval of the full board of Sinovac Beijing, to Mr. Weidong Yin, Ms. Nan Wang, and other senior managers of Sinovac Beijing purporting to terminate their employment. The board of directors of Sinovac Beijing subsequently determined, with the advice of PRC legal counsel, that this action did not conform with the joint venture contract and the articles of association of Sinovac Beijing and was unlawful. As also described above, the representative of Sinobioway Medicine and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and limited the physical movements of employees in Sinovac Beijing’s general manager’s office and finance department in an attempt to wrongfully take control of Sinovac Beijing’s official seal, legal documents, accounting seal, financial documents and financial information systems. As a result of these actions, our ability to attract and retain the talent required for our business may be materially harmed.
In addition, recruiting and retaining additional qualified scientific, technical and managerial personnel and research partners will be critical to our success. Competition among biopharmaceutical and biotechnology companies for qualified employees in China is intense and turnover rates are high. There is a shortage of employees in China with expertise in our areas of research and clinical and regulatory affairs, and this shortage is likely to continue. In addition, we have a limited number of shares available for issuance under our share incentive award plan, which may affect our ability to retain and motivate our employees. We may not be able to retain existing personnel or attract and retain qualified staff in the future. If we fail to hire and retain personnel in key positions, we may be unable to develop or commercialize our product candidates in a timely manner.
We may encounter difficulties in managing our growth, which could adversely affect our results of operations.
We have experienced rapid and substantial growth and, if such growth continues, will place a strain on our administrative and operational infrastructure. We also plan to introduce new products to market that, if successful, could place a strain on our administrative and operational infrastructure. If we are unable to manage this growth effectively, our business, results of operations or financial condition may be materially and adversely affected. Our ability to manage our operations and growth effectively requires us to continue to improve our operational, financial and management controls, reporting systems and procedures and hiring programs. We may not be able to successfully implement these required improvements.
International expansion may be costly, time-consuming and difficult. If we do not successfully expand internationally, our growth strategy and prospects would be materially and adversely affected.
We have entered into selected international markets and intend to continue to expand the sales of our products into new international markets. In expanding our business internationally, we have entered, and intend to continue to enter, markets in which we have limited or no experience and in which our brand may be less recognized. To promote our brand and generate demand for our products to attract distributors in international markets, we expect to spend significantly more on marketing and promotion than we do in our existing domestic markets when appropriate. We may be unable to attract a sufficient number of distributors, and our selected distributors may not be suitable for selling our products.
In new markets, we may fail to anticipate competitive conditions that are different from those in our existing markets. These competitive conditions may make it difficult or impossible for us to effectively operate in these markets. If our expansion efforts in existing and new internal markets are unsuccessful, our growth strategy and prospects would be materially and adversely affected.
We are exposed to other risks associated with international operations, including:
• | political instability; |
• | economic instability and recessions; |
• | trade wars and trade disputes; |
• | changes in tariffs; |
• | difficulties of administering foreign operations generally; |
• | limited protection for intellectual property rights; |
• | obligations to comply with a wide variety of foreign laws and other regulatory approval requirements; |
• | increased risk of exposure to terrorist activities; |
• | financial condition, expertise and performance of our international distributors; |
• | export license requirements; |
• | unauthorized re-export of our products; |
• | potentially adverse tax consequences; |
• | inability to effectively enforce contractual or legal rights; and |
• | exchange rate fluctuations or devaluation of foreign currencies. |
We may undertake acquisitions which may have a material adverse effect on our ability to manage our business and may end up being unsuccessful.
Our growth strategy may involve the acquisition of new production lines, technologies, businesses, products or services or the creation of strategic alliances in areas in which we do not currently operate. These acquisitions and strategic alliances could require that our management develop expertise in new areas or new geographies, manage new business relationships and attract new types of customers. Furthermore, acquisitions may require significant attention from our management, and the diversion of our management’s attention and resources could have a material adverse effect on our ability to manage our business. We may experience difficulties integrating acquisitions into our existing business and operations. Future acquisitions may also expose us to potential risks, including risks associated with:
• | the integration of new operations, services and personnel; |
• | unforeseen or hidden liabilities; |
• | the diversion of resources from our existing businesses and technologies; |
• | our inability to generate sufficient revenue to offset the costs of acquisitions; |
• | potential loss of, or harm to, relationships with employees or customers, any of which could significantly disrupt our ability to manage our business and materially and adversely affect our business, financial condition and results of operations; and |
• | impairment of intangible assets acquired. |
We may be unable to ensure compliance with United States economic sanctions laws, especially when we sell our products to distributors over which we have limited control.
The U.S. Department of the Treasury’s Office of Foreign Assets Control administers certain laws and regulations that impose penalties upon U.S. persons and, in some instances, foreign entities owned or controlled by U.S. persons, for conducting activities or transacting business with certain countries, governments, entities or individuals subject to U.S. economic sanctions or (“U.S. Economic Sanctions Laws.Laws”). We will not use any proceeds, directly or indirectly, from sales of our common shares, to fund any activities or business with any country, government, entity or individual with respect to which U.S. persons or, as appropriate, foreign entities owned or controlled by U.S. persons, are prohibited by U.S. Economic Sanctions Laws from conducting such activities or transacting such business.
However, we sell our products in international markets through independent non-U.S. distributors which are responsible for interacting with the end-users of our products. We may not be able to ensure that such non-U.S. distributors fully comply with all applicable U.S. Economic Sanctions Laws. Moreover, if a U.S. distributor conducts activities or transacts business with a country, government, entity or individual subject to U.S. economic sanctions, such actions may violate U.S. Economic Sanctions Laws. As a result of the foregoing, actions could be taken against us that could materially and adversely affect our reputation and have a material adverse effect on our business, financial condition, results of operations and prospects.
We may be classified as a passive foreign investment company, which could result in adverse U.S. federal income tax consequences to U.S. Holders of our common shares.
Based on the market price of our common shares and the value of our assets and(subject to the discussion below) as well as the composition of our income and assets, we do not believe we were a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes for our taxable year ended December 31, 2017.2020. However, the application of the PFIC rules is subject to uncertainty in several respects, and we cannot assure youthat we will not be a PFIC for any taxable year. AIn general, a non-U.S. corporation will be a PFIC for any taxable year if either (i) at least 75% of its gross income for such year is passive income or (ii) at least 50% of the value of its assets (based(generally based on a quarterly average) during such year is attributable to assets that produce passive income or are held for the production of passive income. We must make a separate determination after the close of each taxable year as to whether we were a PFIC for that year. TheIn particular, under normal circumstances, the value of our assets for purposes of the PFIC test for a particular taxable year would generally be determined by reference to the market price of our common shares at the end of each quarter during such taxable year. As a result, fluctuations in the market price of our common shares (or changes in the composition of our income or assets) may cause us to become a PFIC for any subsequent year. However, as a result of the suspension of trading in our shares, we are unable to reference the actual market prices of our common shares in determining our PFIC status. As a result, we have based our valuation on the market price as of the last date of the last trading day of our common shares as well as on certain financial valuation determinations by third parties in connection with our recent financing transactions. We cannot provide any assurances that the actual value of our shares are not materially different on actual measurement dates and as to whether the IRS will respect our approach. This uncertainty will continue so long as trading in our shares remains suspended. In addition, the composition of our income and assets will be affected by how, and how quickly, we use anythe cash we generate from our operations or raise in any offering. Because the value of our assets for purposes of the PFIC test will generally be determined by reference to the market price of our common shares, fluctuations in the market price of our common shares may cause us to become a PFIC for any subsequent year. If we are a PFIC for any year during which a U.S. Holder (as defined in “Item 10. Additional Information — E. Taxation — United States Federal Income Taxation”) holds our common shares, additional reporting requirements and certain adverse U.S. federal income tax consequences could apply to such U.S. Holder. Please see “Item 10. Additional Information — E. Taxation — United States Federal Income Taxation — Passive Foreign Investment Company.”
Negative publicity regarding vaccinations in China may lead to lower demand for vaccination, which could in turn negatively affect our business, financial condition and results of operations.
In December 2013, it was reported that several infants died shortly after receiving inoculations of hepatitis B vaccine produced by a domestic company in China. The PRC State Food and Drug Administration, or CFDA,NMPA and National Health and Family Planning Commission have determined that the inoculated hepatitis B vaccines comply with the applicable regulatory standards. In March 2016, media reported on improperly stored vaccines illegally sold in Shandong province and all across China. The illegal distribution started in 2010 and two suspects were detained by police in 2015. Although experts from the World Health Organization or WHO,(“WHO”) has confidence in China’s vaccine industry and publicly clarified their position several times since news of this scandal broke, public concerns remain. SuchIn July 2018, Changchun Changsheng Life Science Co., Ltd. was found by the government to have falsified production records. Although the government has determined to levy a $1.3 billion fine on the company, such negative publicity may leadhas led to lower demand for vaccination in China in 2018, which couldhas in turn negatively affectaffected the whole vaccine industry and our business, financial condition and results of operations.industry.
As a foreign private issuer, we are subject to different U.S. securities laws and NASDAQ listing rules than domestic U.S. issuers.
As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the furnishing and content of quarterly reports and proxy statements, and officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, as an Antigua and Barbuda company listed on the NASDAQ Global Select Market, we are subject to NASDAQ'sNASDAQ’s corporate governance requirements. However, NASDAQ listing rules permit a foreign private issuer like us to elect to follow home country corporate governance practices in lieu of certain NASDAQ corporate governance standards, subject to certain conditions. Certain corporate governance practices in Antigua and Barbuda, which is our home country, may differ significantly from the NASDAQ standards. As a result of our status as a foreign private issuer, you may not be afforded the same information or protections that would be made available to you were you investing in a domestic U.S. issuer.
Trading of our common shares on NASDAQ has been halted since February 22, 2019.
In connection with the Exchange and the issuance of the Exchange Shares into the Shareholder 2019 Rights Exchange Trust, NASDAQ implemented a halt in trading in Sinovac Antigua’s common shares in order to facilitate the orderly distribution of the Exchange Shares. In light of the ongoing litigation concerning the Rights Agreement, there can be no assurance when or if this halt will be lifted. NASDAQ has continued listing standards that we must maintain on an ongoing basis in order to continue the listing of our common shares. If NASDAQ determines that we fail to meet these continued listing requirements, our common shares may be subject to delisting.
If our common shares are delisted and we are not able to list our common shares on another national securities exchange, we expect our securities would be quoted on an over-the-counter market. If this were to occur, our shareholders could face significant material adverse consequences,
including limited availability of market quotations for our securities and reduced liquidity for the trading of our securities. In addition, we could experience a decreased ability to issue additional securities and obtain additional financing in the future.
Risks Related to Government Regulation
We may not be able to comply with applicable GMP standards and other regulatory requirements, which could have a material adverse effect on our business, financial condition and results of operations.
We are required to comply with applicable GMP regulations, which include, among other things, requirements relating to personnel, premises and equipment, raw material and products, qualification and validation, document management, production management, quality control and assurance and product distribution and recall. Manufacturing facilities must be approved by governmental authorities before they can be used to commercially manufacture our products and are subject to inspection by regulatory agencies. We havehad been required to comply with the new GMP standards implemented by CFDANMPA since March 1, 2011. All2011 and all vaccine manufacturers were required to meet the new GMP standards and obtain certifications for their manufacturing facilities by December 31, 2013. Any manufacturer that failed to meet the deadline would bewere forced to suspend production.
We have obtained the new GMP certificates for all of our commercial production facilities. However, we cannot assure you that we will be able to continue to meet the applicable GMP standards and other regulatory requirements in the future.
In addition, in light of the incident where vaccines were illegally sold and distributed in Shandong province and other provinces around China in 2016, the government has changed policies and regulations related to the vaccine sales and distribution in China. Before the policy was issued, human vaccine sales were halted in China for months. Although theThe vaccine purchase and delivery was resumed in second half of 2016, we2016. We are not able to estimate whether there will be any other change of policies and regulations on our business in the future, which will negatively impact on business in the future.
The 2020 Chinese Pharmacopoeia came into effect on December 30, 2020. We have made a thorough assessment on the 2020 Chinese Pharmacopeia and updated our operation procedures according to the new regulatory requirements to ensure full compliance.
If we fail to comply with applicable regulatory requirements at any stage during the regulatory process, including following any product approval, we may be subject to sanctions, including:
• | fines; |
• | product recalls or seizures; |
• | injunctions; |
• | refusal of regulatory agencies to review pending market approval applications or supplements to approval applications; |
• | total or partial suspension of production; |
• | civil penalties; |
• | withdrawals of previously approved marketing applications; and |
• | criminal prosecution. |
We can only sell products that have received regulatory approvals. Many factors affect our ability to obtain such approvals.
Pre-clinical and clinical trials of our products, and the manufacturing and marketing of our products, are subject to extensive, costly and rigorous regulation by governmental authorities in the PRC and in other countries. Even if we complete pre-clinical and clinical trials successfully, we may not be able to obtain applicable regulatory approvals. We cannot market any product candidate until we have both completed our clinical trials and obtained the necessary regulatory approvals for that product candidate.
Conducting clinical trials and obtaining regulatory approvals are uncertain, time-consuming and expensive processes. The process of obtaining required regulatory approvals from the CFDANMPA and other regulatory authorities often takes many years and can vary significantly based on the type, complexity and novelty of the product candidates. For example, it took us approximately ten years to develop and obtain regulatory approval to commercialize Healive, and it took us five and a half years and four and a half years to develop and obtain regulatory approvals to commercialize Bilive and Anflu, respectively. EV71 vaccine above all, took us eight years from 2008 to 2016 to develop and obtain regulatory approvals.
There can be no assurance that all of the clinical trials pertaining to our vaccines in development will be completed within the timeframes currently anticipated by us. We could encounter difficulties in enrolling vaccineespatients for clinical trials or encounter setbacks while conducting clinical trials that result in delays or cancellation. Data obtained from pre-clinical and clinical studies are subject to varying interpretations that could delay, limit or prevent regulatory approval,approvals, and failure to observe regulatory requirements or inadequate manufacturing processes are examples of other problems that could prevent approval.approvals. In addition, we may encounter delays or rejections in the event of additional regulation from future legislation, administrative action or changes in the CFDANMPA policy or if unforeseen health risks become an issue with the participants of clinical trials.
Clinical trials may also fail at any stage. Results of early trials frequently do not predict results of later trials, and acceptable results in early trials may not be repeated. For these reasons, we do not know whether regulatory authorities will grant approval for any of our product candidates in the future. In addition, production permits for our products are valid for only five years and we need to apply for renewal six months prior to their expiration. The process to approve our renewal applications could be lengthy and there is no assurance that we will be granted renewal in a timely manner or at all.
Delays in obtaining CFDA orNMPA foreign approvals of our products could result in substantial additional costs and adversely affect our ability to compete with other companies. Even if regulatory approval is ultimately granted, we may not maintain the approval and the approval may be withdrawn. Any approval received may also restrict the intended use and marketing of the product we want to commercialize.
Outside the PRC, our ability to market some of our potential products is contingent upon receiving marketing authorizations from the appropriate foreign regulatory authorities. For example, our hepatitis A vaccine, Healive, can be supplied to certain international organizations and is eligible to participate into the tender process in some countries as it has passed the WHO prequalification assessment or (“WHO PQ.PQ”). However, there are still many other countries that require additional marketing authorization to sell in such countries despite the WHO PQ status. These foreign regulatory approval processes include the risks associated with the CFDANMPA approval process described above and may include additional risks.
Because the medical conditions that our vaccines are intended to prevent represent significant public health threats, we are at risk of governmental actions detrimental to our business, such as product seizure, compulsory licensing and additional regulations.
In response to a pandemic or the perceived risk of a pandemic, governments in the PRC and other countries may take actions to protect their citizens that could affect our ability to control the production and export of pandemic vaccines or otherwise impose burdensome regulations on our business. For example, an outbreak of influenza and the recent COVID-19 could subject our manufacturing locationsfacilities to seizure by the PRC government. The PRC government may alsomight grant compulsory licenses to allow our competitors to manufacture products that are protected by our patents or use our technology, developed using funds received from government agencies.
We deal with hazardous materials that may cause injury to others. These materials are regulated by environmental laws that may impose significant costs and restrictions on our business.
Our research and development programs and manufacturing operations involve the controlled use of potentially harmful biological materials and other hazardous materials. We cannot eliminate the risk of accidental contamination or injury to our employees or others from the use, manufacture, storage, handling or disposal of hazardous materials and certain waste products. In the event of contamination or injury, we could be held liable for any resulting damages, and anythe liability could exceed our resources or any applicable insurance coverage we may have.
We are also subject to PRC laws and regulations governing the construction and operation of production facilities that may have an impact on the environment and the use, manufacture, storage, handling or disposal of hazardous materials and waste products, such as the PRC Environmental Impact Assessment Law, the PRC Prevention and Control of Water Pollution Law and the PRC Environmental Protection Law, as well as waste-disposal standards set by relevant governmental agencies. It is likely that China will continue to adopt stricter pollution controls as the country is experiencing increasingly serious environmental pollution. Although weour facilities have passed anprevious environmental examination of our facilities conducted in 2004 by the Beijing Municipal Environment Protection Bureau, on our hepatitis A vaccine production line and passed the same examination on our seasonal flu vaccine production line and filling and packaging line in 2005 and 2008, respectively, we cannot assure you that we will continue to pass similar environmental examinations on any future production facilities that we may construct. In addition, according
We have already obtained the approval of the environmental impact assessment report from relevant regulatory authorities for our relevant construction plan of our facilities, however, we cannot assure that we will continue to obtain the approval on environmental impact assessment report for any future production facilities that we may construct. According to the PRC Environmental Impact Assessment Law, after the approval of previous environmental impact assessment report, if there is any material change in the nature, scale, location, production technology used and measures adopted to prevent damages to ecology, new environmental impact assessment reports need to be filed for approval.
We have already obtained the approval of the environmental impact assessment report from the Beijing Municipal Environment Protection Bureau for the construction plan of our facilities in Changping District, Beijing. We produce Bilive vaccine at our production facility for hepatitis A vaccine and produce Panflu and Panflu.1 vaccines at our production facility for seasonal flu or Anflu vaccine. We have canceled the construction plan for our influenza vaccine production facility in Changping. A new environmental impact assessment report regarding the change has been submitted to the relevant environment protection authorities and has passed the government inspection. We also added a sIPV production facility to the Changping construction plan. The relevant environmental impact assessment report was submitted to the relevant government authorities and passed the government evaluation. The approval on this report was already obtained. Once the construction of sIPV is completed, we will apply for government inspection on the completion of the plant.
In addition, we have obtained approval for the environmental impact assessment report for PPV production facility at our Shangdi site. We are required to pass the government inspection to launch the commercial production of PPV. If we fail to pass the inspection, we cannot commence commercial production of the product. Moreover, we do not currently have a pollution and remediation insurance policy to mitigate any risk related to environmental pollution or violation of environmental law.
Failure to commence development of land which we have been granted right to use within the required timeframe may cause us to lose our land use rights.
Sinovac Dalian was granted land use rights to two parcels of land, with an aggregate area of 95,686 square meters (approximately 1,030,000 square feet) located in the Economic and Technical Development Zone of Dalian, Liaoning province by the local government. According to the relevant PRC regulations, a parcel of land may be treated as idle land if development of the land has not been commenced within one year after the commencement date stipulated in the land use rights grant contract or the issuance date of the construction land approval certificate. Land users can extend the deadline for commencing the construction work for one year.
All of our current facilities of Sinovac Dalian are located at one of the two parcels of the land with an aggregated area of 55,606 square meters (598,582 square feet). However, as of the date of this annual report, we have not commenced development of the other parcel of the land with 40,080 square meters (431,418 square feet), which Sinovac Dalian was granted the right to use. The PRC government may treat the land as idle land, in which case we may be required to pay idle land fees or penalties, change the intended use of the land, find another parcel of land, or even be required to forfeit the land to PRC government, any of which would adversely affect our financial condition.
Negative publicity regarding China-based companies listed in the United States may affect the trading price of our common shares and result in increased regulatory scrutiny of our business.
In the past, litigation and negative publicity surrounding companies with operations in China listed in the United States have resulted in declining stock prices for such companies. Various equity research organizations have published reports on China-based companies after examining their corporate governance practices, related party transactions, sales practices and financial statements that have led to special investigations and stock suspensions on national exchanges. Any similar scrutiny of us, regardless of merit, could result in a diversion of our management’s attention from managing our core business, negative publicity, potential costs to defend ourselves against rumors, volatility and loss in the trading price of our common shares and increased directors’ and officers’ insurance premiums, any of which could materially and adversely affect our business, financial condition and results of operations.
Uncertainties exist with respect to how the PRC Vaccine Administration Law may impact our current operations.
Risks RelatedThe PRC Vaccine Administration Law became effective on December 1, 2019. It is China’s first legislation dedicated to the regulation of vaccine industry. According to the law, the supervision of vaccines will cover the whole lifecycle from vaccine development, production and distribution to vaccination. Specialized inspection teams of pharmaceutical professionals will be established at the central and provincial levels to conduct the supervision work. An electronic information system will also be set up to make all information on vaccines trackable during vaccine production, distribution and vaccination. The vaccine tracking system requires vaccination data, including vaccine's information, expiry date and use date, the medical workers who issue the vaccines and their recipients, should be recorded and retained for at least five years after its expiry. The law imposes tough punishments on wrongdoers, stipulating that people whose violations constitute a crime shall bear heavier criminal responsibility. The move under the PRC Vaccine Administration Law could be a milestone in vaccine safety, while bringing back market confidence in the regulatory system. The new law is believed to be able to enable the regulators to close loopholes and rein in risks in vaccine management and boost the confidence of the public in vaccine products manufactured in China. Since the Vaccine Administration Law was recently promulgated, no detailed implementing rules have been promulgated so far, and it is unclear how this regulation will be interpreted, amended and implemented by the relevant PRC government authorities. In addition, PRC judicial and administrative authorities have significant discretion in interpreting and implementing statutory and contractual terms. We cannot predict how the new law will affect our business operations or future strategy.
Our Intellectual Property
If we are unable to protect our technologies from competitors with patents or other forms of intellectual property protection, our business may be harmed.
Our success depends, in part, on our ability to protect our proprietary technologies. We try to protect the technology that we consider important to our business by filing PRC patent applications and relying on trade secret and pharmaceutical regulatory protection.
protection, including our existing and potential vaccines.
We have a total of 5168 issued patentsand a number of pending patent applications relating to our vaccines in China. The process of seeking patent protection in China can be lengthy and expensive and we cannot assure you that our pending patent applications, or any patent applications we may make in the future with respect to other products, will result in issued patents, or that any patents issued in the future will be able to provide us with meaningful protection or commercial advantage. Our patent applications maymight be challenged, invalidated or circumvented in the future.
circumvented.
In addition to patents, we rely on trade secrets and proprietary know-how to protect our intellectual property. We have entered into confidentiality agreements (which include, in the case of employees, non-competition provisions) with many of our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of our employees, the agreements provide that all of the technology which is conceived by the individual during the course of employment is our exclusive property. These agreements may not provide meaningful protection or adequate remedies in the event of unauthorized use or disclosure of our proprietary information. In addition, third parties could possibly independently develop information and techniques substantially similar to ours or otherwise gain access to our trade secrets.
Our current or potential competitors, many of whom have substantial resources and have made substantial investments in competing technologies, could develop products that compete directly with our products despite our intellectual property rights.
Intellectual property rights and confidentiality protections in China may not be as effective as in the United States or other developed countries. Policing unauthorized use of proprietary technology is difficult and expensive, and we might need to resort to litigation to enforce or defend
patents issued to us or to determine the enforceability, scope and validity of our proprietary rights or those of others. The experience and capabilities of PRC courts in handling intellectual property litigation varies, and outcomes are unpredictable. Further, such litigation may require significant expenditures of cash and management efforts and could harm our business, financial condition and results of operations. An adverse determination in any such litigation could materially impair our intellectual property rights and may harm our business, prospects and reputation.
We may be exposed to infringement or misappropriation claims by third parties which, if determined adversely to us, could cause substantial liabilities to us, or we may be unable to sell some of our products. Please see “Item 4. Information on the Company — B. Business Overview — Intellectual Property and Proprietary Technology.”
Third parties may bring intellectual property infringement claims against us in the future.
Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Even after reasonable investigation, we may not know with certainty whether we have infringed upon a third party’s patent due to the complexity of patent claims, the inadequacy of patent clearance search procedures in the PRC and the fact that a third party may have filed a patent application without our knowledge while that product was under development by us.
Patent applications are maintained in secrecy until their publication 18 months after the filing date. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. China, similar to many other countries, adopts the first-to-file system under which the first party to file a patent application (instead of the first to invent the subject invention) may be awarded a patent. There may also be technologies licensed to us or acquired by us that are subject to infringement, misappropriation or other claims by others which could damage our ability to rely on such technologies.
If a third party claims that we infringe upon its proprietary rights, any of the following may occur:
• | we may become involved in time-consuming and expensive litigation, even if the claim is without merit; |
• | we may become liable for substantial damages for past infringement if a court decides that our technology infringes upon a |
• | a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially reasonable terms, if at all, or which may require us to pay substantial royalties or grant cross licenses to our patents; |
• | we may have to reformulate our product so that it does not infringe upon others’ patent rights, which may not be possible or could be very expensive and time-consuming; and |
• | we may be subject to injunctions prohibiting the manufacture and sale of our products or the use of our |
If any of these events occurs, our business will suffer and the market price of our common shares could decline.
The success of our business may depend on licensing vaccine components from, and entering into collaboration arrangements with, third parties. We cannot be certain that our licensing or collaboration efforts will succeed or that we will realize any revenue from them.
The success of our business strategy depends, in part, on our ability to enter into licensing and collaboration arrangements and to effectively manage the resulting relationships. Our ability to enter into agreements with commercial partners depends in part on our ability to convince them of the value of our technology and know-how. This may require substantial time and effort. While we anticipate expending substantial funds and management effort, we cannot assure you that strategic relationships will result or that we will be able to negotiate additional strategic agreements in the future on acceptable terms, if at all.
We may incur significant financial commitments to collaborators in connection with potential licenses and sponsored research agreements. In addition, we may not be able to control the areas of responsibility undertaken by our strategic partners and may be adversely affected should these partners prove to be unable to carry a product candidate forward to full commercialization or should they lose interest in dedicating the necessary resources toward developing any such product quickly.
Third parties may terminate our licensing and other strategic arrangements if we do not perform as required under these arrangements. Generally, we expect that agreements for rights to develop technologies will require us to exercise diligence in bringing product candidates to market and may require us to make milestone and royalty payments that, in some instances, could be substantial. Our failure to exercise the required diligence or make any required milestone or royalty payments could result in the termination of the relevant license agreement, which could have a material adverse effect on us and our operations. In addition, these third parties breach or terminate their agreements with us or otherwise fail to conduct their activities in connection with our relationships in a timely manner. If we or our partners terminate or breach any of our licenses or relationships, we may:
• | lose our rights to develop and market our product candidates; |
• | lose patent and/or trade secret protection for our product candidates; |
• | experience significant delays in the development or commercialization of our product candidates; |
• | not be able to obtain any other licenses on acceptable terms, if at all; and |
• | incur liability for damages. |
Licensing arrangements and strategic relationships in our industry can be complex, particularly with respect to intellectual property rights. Disputes may arise in the future regarding ownership rights to technology developed by or with other parties. These and other possible disagreements between us and third parties with respect to our licenses or our strategic relationships could lead to delays in the research, development, manufacture and commercialization of our product candidates. These disputes could also result in litigation or arbitration, both of which are time-consuming and expensive. Moreover, Thesethese third parties may pursue alternative technologies or product candidates either on their own or in strategic relationships with others in direct competition with us.
Any cessation or suspension of our collaborations with scientific advisors and academic institutions may increase our costs in research and development, lengthen our new vaccines development process and lower our efficiency in new products development.
We work with scientific advisors and academic collaborators who assist us in some of our research and development efforts. Some of our pre-clinical and research programs rely heavily on such collaborators and we generally benefit considerably from the resources, technology and experience these collaborations can provide. These scientists are not, however, our employees and may have other commitments that limit their availability to us. If a conflict of interest arises between their work for us and their work for another entity, we may lose the services of these scientists and institutions. Any cessation or suspension of our collaborations with scientific advisors and academic institutions may increase our research and development costs, lengthen our new vaccinesvaccine development process and lower our efficiency in new products development. In addition, although our scientific advisors and academic collaborators generally sign agreements not to disclose our confidential information, valuable proprietary knowledge may become publicly known which would compromise our competitive advantage.
We may lose the right to use “科兴” (Kexing) on our vaccine products and/or as part of our trade name.
We currentlySince 2001, Sinovac Beijing has been using “科兴” (Kexing) as part of its Chinese trade name. Sinovac Dalian began to use “科兴” (Kexing) as part of Sinovac Beijing’sits Chinese trade name in the PRC. We also use2010. Shenzhen Kexing successfully registered “科兴” (Kexing) as part of the Chinese trade name of Sinovac Dalian in the PRC. Shenzhen Kexing currently owns the “科兴” trademark registered in China for Class 5 (Pharmaceuticals) under the International Classification of Goods and Services.Services in 2001. To protect our interest in using “科兴” in our trade name,names, we applied to register “科兴” in China for Class 42 (Scientific & Technological Services &Research) in 2006 and the PRC Trademark Office of the State Administration for Industry and Commerce approved our application in 2010. The
As of the date of this annual report, the “科兴” trademark registered and owned by Shenzhen Kexing has not been identified as “Well-known Trademark” by the relevant PRC authorities since we first started using “科兴” in the trade name of Sinovac Beijing in 2001.authorities. If the “科兴” trademark owned by Shenzhen Kexing is ever officially identified as a “Well-Known Trademark,”Trademark” in the future, however, we may be subject to trademark infringement claim for the use of “科兴” in our trade name. Although the trademark application and the trade name approval systems are administered separately in China, itnames. It is possible that we maymight lose our ability to use the “科兴” trademark in our trade namenames due to a successful trademark infringement claim, which may adversely affect our ability to maintain and protect our brands, cause us to incur litigation costs and divert resources and management attention.
Risks Related to Doing Business in China
Adverse changes in political, economic and other policies of the PRC government could have a material adverse effect on the overall economic growth of China, which could reduce the demand for our products and materially and adversely affect our competitive position.
We conduct alla significant part of our operations in China, and generategenerated approximately 99.2%71.6% of our sales in China.China in 2020. Accordingly, our business, financial condition, results of operations and prospects are affected significantly by economic, political and legal developments in China. The Chinese economy differs from the economies of most developed countries in many respects, including:
• | the extent of government involvement; |
• | the level of development; |
• | the growth rate; |
• | the control of foreign exchange; |
• | the allocation of resources; |
• | an evolving regulatory system; and |
• | a lack of sufficient transparency in the regulatory process. |
While the Chinese economy has experienced significant growth in the past 30 years, growth has been uneven, both geographically and among various sectors of the economy. The PRC government has implemented measures to encourage economic growth and guide the allocation of resources. Some of these measures benefit the overall Chinese economy, but may also have a negative effect on us. For example, our financial condition and results of operations may be adversely affected by government control over capital investments or changes in tax regulations that are applicable to us.
The Chinese economy has been transitioning from a planned economy to a more market-oriented economy. Although in recent years the PRC government has implemented measures emphasizing the utilization of market forces for economic reform, the reduction of state ownership of productive assets and the establishment of sound corporate governance in business enterprises, the Chinese government still owns a substantial portion of the productive assets in China. The continued control of these assets and other aspects of the national economy by the PRC government could materially and adversely affect our business. The PRC government also exercises significant control over Chinese economic growth by allocating of resources, controlling payment of foreign currency-denominated obligations, setting monetary policy and providing preferential treatment to particular industries or companies. Efforts by the PRC government to slow the pace of growth of the Chinese economy could result in hospitals spending less, which in turn could reduce demand for our products.
The political relationship among foreign countries and China is subject to sudden fluctuations and periodic tensions. Changes in political conditions in China and changes in the state of foreign relations are difficult to predict and could adversely affect our product export and international collaborations. This could lead to a decline in our profitability in the future.
Although the Chinese economy has grown significantly in the past decade, that growth may not continue, as evidenced by the slowing of the growth of the Chinese economy since 2012. Any adverse change in the economic conditions or government policies in China, including the economic slowdown in 2020 due to the COVID-19 pandemic, could have a material adverse effect on overall economic growth and the level of healthcare investments and expenditures in China, which in turn could lead to a reduction in demand for our products and consequently have a material adverse effect on our businesses.
Future changes in laws, regulations or enforcement policies in China could adversely affect our business.
Laws, regulations and enforcement policies in China, including those regulating our business, are evolving and subject to future change. Future changes in laws, regulations or administrative interpretations, or stricter enforcement policies by the PRC government, could impose more stringent requirements on us, including fines or other penalties. Changes in applicable laws and regulations may also increase our operating costs. Compliance with such requirements could impose substantial additional costs or otherwise have a material adverse effect on our business, financial condition and results of operations. These changes may relax some requirements, which could be beneficial to our competitors or could lower market entry barriers and increase competition. Further, regulatory agencies in China may, sometimes abruptly, change their enforcement practices.
Prior enforcement activity, or lack of enforcement activity, is not necessarily predictive of future actions. Any enforcement actions against us could have a material adverse effect on us and the market price of our common shares. In addition, any litigation or governmental investigation or enforcement proceedings in China may be protracted and may result in substantial costs and diversion of resources and management attention, negative publicity, damage to our reputation and decline in the price of our common shares.
We rely on dividends paid by our PRC subsidiaries for our cash needs. If they are unable to pay us sufficient dividends due to statutory or contractual restrictions on their abilities to distribute dividends to us, our various cash needs may not be met.
We are a holding company, and we rely on the dividends paid by our PRC subsidiaries, including majority-owned subsidiaries Sinovac Beijing, Sinovac Dalian and Sinovac DalianLS and our wholly owned subsidiariessubsidiary Sinovac R&D (formerly known as Biomed Co., Ltd. (“Sinovac Biological) and Sinovac BiomedBiomed”) for our cash needs, including the funds necessary to pay any dividends and other cash distributions to our shareholders, service any debt we may incur and pay our operating expenses. The payment of dividends in the PRC is subject to limitations. Regulations in the PRC currently permit payment of dividends by our PRC subsidiaries only out of accumulated profits as determined in accordance with accounting standards and regulations in China. For instance, in accordance with the regulations in China, Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS and Sinovac Biomed are required to set aside at least 10% of its after-tax profits each year to contribute to its reserve fund until the accumulated balance of such reserve fund reaches 50% of the registered capital of each company.
As described above, a representative of Sinobioway Medicine, who is the Chairman of the board of directors of Sinovac Beijing, and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and limited the physical movements of employees in Sinovac Beijing’s general manager’s office and finance department in an attempt to wrongfully take control of Sinovac Beijing’s official seal, legal documents, accounting seal, financial documents and financial information systems. As a result of these actions, the ability of Sinovac Beijing to pay dividends for our cash needs may be materially impacted.
Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS and Sinovac Biomed are also required to set aside, at the discretion of their respective board of directors, a portion of their annual income after taxes to their employee welfare and bonus funds. These funds reduce the ability of the subsidiaries to pay dividends in cash.
In addition, if Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS or Sinovac Biomed incurs debt on its own behalf in the future, the instruments governing the debt may restrict either company’s ability to pay dividends or make other distributions to us.
Restrictions on currency exchange may limit our ability to receive and use our revenues effectively.
We receive over 99%72% of our revenues in renminbi, which currently is not a freely convertible currency. A portion of our revenues may be converted into other currencies to meet our foreign currency obligations, including, among others, payment of dividends declared by our
subsidiaries. Under China’s existing foreign exchange regulations, Sinovac Beijing, Sinovac R&D,LS, Sinovac Dalian and Sinovac Biomed are able to pay dividends in foreign currencies without prior approval from the State Administration of Foreign Exchange or SAFE,(“SAFE”) by complying with certain procedural requirements. However, the PRC government could not take future measures to restrict access to foreign currencies for current account transactions.
Our PRC subsidiaries’ ability to obtain foreign exchange is subject to significant foreign exchange controls and, in the case of amounts under the capital account, requires the approval of and/or registration with PRC government authorities, including SAFE. In particular, if we finance our PRC subsidiaries by means of foreign currency from us or other foreign lenders, the amount is not allowed to exceed the difference between the amount of total investment and the amount of the registered capital as approved by the Ministry of Commerce and registered with SAFE. Such loans must also be registered with SAFE.SAFE as foreign debts. If we finance our PRC subsidiaries by means of additional capital contributions from offshore, the amount of these capital contributions must first be approved by the relevant government approval authority. These limitations could affect the ability of our PRC subsidiaries to obtain foreign exchange through debt or equity financing.
Fluctuation in the value of the renminbi may have a material adverse effect on your investment.
The value of the renminbi against the U.S. dollar, Euro and other currencies is affected by, among other things, changes in China’s political and economic conditions and China’s foreign exchange policies. The PRC government allows the renminbi to fluctuate within a narrow and managed band against a basket of certain foreign currencies. In recent years, the exchange rate between the renminbi and U.S. dollar has been relatively stable and consequently the renminbi has sometimes fluctuated sharply against other freely traded currencies, in tandem with the U.S. dollar.
Since June 2010, the Renminbi has fluctuated against the U.S. dollar. Since October 1, 2016, the RMB has joined the International Monetary Fund’s basket of currencies that make up the Special Drawing Right, along with the U.S. dollar, the Euro, the Japanese yen and the British pound. InSince the fourth quarter of 2016, the RMB depreciated significantly in the backdrop of a surging U.S. dollar and persistent capital outflows of China. With the development of the foreign exchange market and progress towards interest rate liberalization and Renminbi internationalization, the PRC government may announce further changes to the exchange rate system and the RMB could appreciate or depreciate significantly in value against the U.S. dollar.
It is difficult to predict how long such depreciation of the RMB against the U.S. dollar may last and when and how the relationship between the renminbi and the U.S. dollar may change again. The PRC government indicated that it will make the foreign exchange rate of the renminbi more flexible and widen the trading band of renminbi, which increases the possibility of sharp fluctuations in renminbi’s value in the future as well as the unpredictability associated with renminbi’s exchange rate. There remains significant international pressure on the PRC government to adopt an even more flexible currency policy, which could result in further and more significant fluctuations of the renminbi against foreign currencies.
As the majority of our costs and expenses are denominated in renminbi, a resumption of the appreciation of the renminbi against the U.S. dollar would further increase our costs in U.S. dollar terms. In addition, as our operating subsidiaries in China receive revenues in renminbi, any significant depreciation of the renminbi against the U.S. dollar may have a material adverse effect on our revenues in U.S. dollar terms and financial condition, and the value of, and any dividends payable on, our common shares. For example, to the extent that we need to convert U.S. dollars into renminbi for our operations, appreciation of the renminbi against the U.S. dollar would have an adverse effect on the renminbi amount we receive from the conversion. Conversely, if we decide to convert our renminbi into U.S. dollars for the purpose of making payments for dividends on our common shares or for other business purposes, appreciation of the U.S. dollar against the renminbi would have a negative effect on the U.S. dollar amount available to us.
Our business benefits from certain government tax incentives. Expiration, reduction or elimination of these incentives will increase our tax expenses and in turn decrease our net income.
Pursuant to the PRC Enterprise Income Tax Law or the EIT Law,(the “EIT Law”) and its implementation rules, both domestic companies and the foreign invested enterprises or the FIEs,(the “FIEs”) are subject to a unified income tax rate of 25%. Tax exemption or reduction with fixed terms enjoyed by enterprises including us will continue until the expiration of the prescribed period. Preferential tax treatments will continue to be granted to high and new technology enterprises that conduct business in encouraged sectors, whether FIEs or domestic companies.
Sinovac Beijing reconfirmed its “High and New Technology Enterprises,” or HNTE, status and obtained the corresponding certificate in 20142020 for a period of three years. As a result, subject to satisfaction of applicable criteria as confirmed by the competent authorities, Sinovac Beijing was entitled to a reduced enterprise income tax or EIT,(“EIT”) rate of 15% from 20142020 to 2016.2022. Sinovac BeijingDalian reconfirmed its HNTE status in 20172020 for another three-year period, which is from 20172020 to 2019.2022. Sinovac Dalian,LS, being confirmed as a HNTE in 20172020 for a period of 3three years, is subject to the preferential EIT of 15% from 20172020 to 2019.2022. The PRC government could eliminate any of these preferential tax treatments before their scheduled expiration. Expiration, reduction or elimination of such tax incentives will increase our tax expenses and in turn decrease our net income.
Under the EIT Law, dividends payable by us and gains on the disposition of our shares may be subject to PRC taxation.
If we were considered a PRC resident enterprise under the EIT Law, our shareholders who are deemed non-resident enterprises may be subject to the EIT at the rate of 10% upon the dividends payable by us or upon any gains realized from the transfer of our shares, if such income is deemed derived from China, provided that (i) such foreign enterprise investor has no establishment or premises in China or (ii) it has an establishment or premises in China but its income derived from China has no real connection with such establishment or premises. If we were required under the EIT Law to withhold PRC income tax on our dividends payable to our non-PRC enterprise shareholders, or if any gains
realized from the transfer of our shares by our non-PRC enterprise shareholders were subject to the EIT, such shareholders’ investment in our shares would be materially and adversely affected.
PRC regulations relating to investments in offshore companies by PRC residents may subject our PRC-resident beneficial owners or our PRC subsidiaries to liability or penalties, limit our ability to inject capital into our PRC subsidiaries or limit our PRC subsidiaries’ ability to increase their registered capital or distribute profits.
SAFE promulgated the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment through Special Purpose Vehicles or (“SAFE Circular 37,37”) on July 4, 2014, which replaced the former circular commonly known as “SAFE Circular 75” promulgated by SAFE on October 21, 2005. SAFE Circular 37 requires PRC residents to register with the local branches of SAFE in connection with their direct establishment or indirect control of an offshore entity, for the purpose of overseas investment and financing, with such PRC residents’ legally owned assets or equity interests in domestic enterprises or offshore assets or interests, referred to in SAFE Circular 37 as a “special purpose vehicle.”
SAFE Circular 37 further requires amendment to the registration in the event of any significant changes with respect to the special purpose vehicle, such as increase or decrease of capital contributed by PRC individuals, share transfer or exchange, merger, division, or other material events. In the event that a PRC shareholder holding interests in a special purpose vehicle fails to fulfill the required SAFE registration, the PRC subsidiaries of that special purpose vehicle may be prohibited from making profit distributions to the offshore parent and from carrying out subsequent cross-border foreign exchange activities, and the special purpose vehicle may be restricted in its ability to contribute additional capital into its PRC subsidiary.
Failure to comply with the various SAFE registration requirements described above could result in liability under PRC law for evasion of foreign exchange controls. According to the Notice on Further Simplifying and Improving Policies for the Foreign Exchange Administration of Direct Investment released on February 13, 2015 by SAFE, local banks will examine and handle foreign exchange registration for overseas direct investment, including the initial foreign exchange registration and amendment registration, under SAFE Circular 37 from June 1, 2015. However, since this notice has not yet come into force, significant uncertainty exists with respect to its interpretation and implementation by governmental authorities and banks.
Mr. Weidong Yin has made the required SAFE registration with respect to his investments in our company. However, we may not be aware of the identities of all of our beneficial owners who are PRC residents. We do not control our beneficial owners and cannot assure you that all of our PRC-resident beneficial owners will comply with SAFE Circular 37 and subsequent implementation rules. The failure of our beneficial owners who are PRC residents to register or amend their foreign exchange registrations in a timely manner pursuant to SAFE Circular 37 and subsequent implementation rules, or the failure of future beneficial owners of our company who are PRC residents to comply with the registration procedures set forth in SAFE Circular 37 and subsequent implementation rules, may subject such beneficial owners or our PRC subsidiaries to fines and legal sanctions.
Furthermore, since SAFE Circular 37 was recently promulgated and it is unclear how this regulation, and any future regulation concerning offshore or cross-border transactions will be interpreted, amended and implemented by the relevant PRC government authorities, we cannot predict how these regulations will affect our business operations or future strategy. Failure to register or comply with relevant requirements may also limit our ability to contribute additional capital to our PRC subsidiaries and limit our PRC subsidiaries’ ability to distribute dividends to our company. These risks may have a material adverse effect on our business, financial condition and results of operations.
Any failure to comply with PRC regulations regarding our employee equity incentive plans may subject the PRC plan participants or us to fines and other legal or administrative sanctions.
Pursuant to SAFE Circular 37, PRC residents who participate in share incentive plans in overseas non-publicly-listed companies due to their position as director, senior management or employees of the PRC subsidiaries of the overseas companies may submit applications to SAFE or its local branches for the foreign exchange registration with respect to offshore special purpose companies. Our directors, executive officers and other employees who are PRC residents and who have been granted options and restricted shares were able to follow SAFE Circular 37 to apply for the foreign exchange registration before our company became an overseas listed company.
Since our company has become an overseas listed company, we and our directors, executive officers and other employees who are PRC residents and who have been granted options are subject to the Notice on Issues Concerning the Foreign Exchange Administration for Domestic Individuals Participating in Stock Incentive Plan of Overseas Publicly Listed Company, issued by SAFE in February 2012, according to which, employees, directors, supervisors and other management members participating in any stock incentive plan of an overseas publicly listed company who are PRC residents are required to register with SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and complete certain other procedures.
Failure to complete SAFE registrations may subject them to fines and legal sanctions and may also limit the ability to make payments under our equity incentive plans or receive dividends or sales proceeds related thereto, or our ability to contribute additional capital into our wholly-foreign owned enterprisessubsidiaries in China and limit our wholly-foreign owned enterprises’such subsidiaries’ ability to distribute dividends to us. We also face regulatory uncertainties that could restrict our ability to adopt additional equity incentive plans for our directors and employees under PRC law.
In addition, the State Administration for Taxation has issued circulars concerning employee share options or restricted shares. Under these circulars, employees working in the PRC who exercise share options, or whose restricted shares or restricted share units, or RSUs, vest, will be subject to PRC individual income tax. The PRC subsidiaries of an overseas listed company have obligations to file documents related to employee
share options or restricted shares with relevant tax authorities and to withhold individual income taxes of those employees related to their share options, restricted shares or RSUs. If the employees fail to pay, or the PRC subsidiaries fail to withhold, their income taxes according to relevant laws, rules and regulations, the PRC subsidiaries may face sanctions imposed by the tax authorities or other PRC government authorities.
PRC regulation of loans and direct investment by offshore holding companies to PRC entities may delay or prevent us from making loans or additional capital contributions to our PRC operating subsidiaries and affiliated entities.
In funding our PRC subsidiaries, we must comply with PRC legal requirements relating to foreign debt registration and to PRC foreign-investment companies’ “registered capital” and “total investment.”investment” ratio. “Registered capital” refers to the capital contributed to or paid into a PRC foreign-investment company in cash or in kind, and “total investment” refers to the estimated amount of the total capital as required to enable and support the full scale operation of a PRC foreign-investment company’s registered capital plus all external borrowings by such company.company when the company is initially established. The amounts of a PRC foreign-investment company’s registered capital and total investment are set forth in the company’s constitutional documentsarticles of association and joint venture contract (in the case of a Sino-foreign joint venture) and approved by the competent government authority in advanceadvance. The balance between the required “total investment” and in the case of Sinovac Beijing“registered capital” can be satisfied by borrowings or loans obtained by the company. In another word, such loans cannot exceed the difference between such company’s registered capital and Sinovac Dalian, must be approved by their minority shareholders, as well as Sinobioway Medicine (formerly named Xiamen Bioway Group Co., Ltd) or Dalian Jin Gang Group, respectively, as well.
total investment.
Loans by us or Sinovac Hong Kong to Sinovac Beijing, Sinovac R&D,LS, Sinovac Dalian or Sinovac Biomed cannot exceed the difference between such company’s registered capital and total investment. The total investment unlessand registered capital can be adjusted after the company has obtainedestablishment of a foreign-investment companies with the approvalapprovals of all the shareholders or unanimous approvals of the approval authority and, inboard of directors. In the case of Sinovac Beijing, Sinovac Dalian or Sinovac Dalian,LS, the approval of Sinobioway Medicine or Dalian Jin Gang Group, respectively,from its respective minority shareholders is required to increase the amount of total investment. Further, suchall the loans from the overseas lenders must be registered with SAFE or its local counterpart.
as foreign debts.
We may also decide to finance our PRC subsidiaries by making additional capital contributions. These additional contributions must be approved by the government approval authority and, in the case of Sinovac Beijing or Sinovac Dalian by Sinobioway Medicine or Dalian Jin Gang Group, respectively.and Sinovac LS, the approval from its respective minority shareholders. We cannot assure you that we will be able to obtain these government registrations or approvals, or the approval of Sinobioway Medicine or Dalian Jin Gang Group,the minority shareholders on a timely basis, if at all, with respect to future loans or additional capital contributions by us to our subsidiaries or affiliates.subsidiaries. If we fail to obtain such registrations or approvals, our ability to capitalize our PRC operations would be negatively affected, which could adversely and materially affect the liquidity of our subsidiaries and our ability to expand ourthe business.
Because we are incorporated under Antigua and Barbuda law, substantially all of our operations, property and assets are located in China and all of our major shareholders, directors and officers and substantially all of their assets are located outside of the United States, you may be unable to protect your shareholder rights under U.S. law in a court in the United States.
We are incorporated in Antigua and Barbuda. Our corporate affairs are governed by our Articles of Incorporation and By-laws and by the International Business Corporations Act and common law of Antigua and Barbuda. The rights of shareholders to take legal action against our directors, officers and us, actions by minority shareholders and the fiduciary responsibilities of our directors to us are to a large extent governed by the International Business Corporations Act and common law of Antigua and Barbuda. The International Business Corporations Act was modelled on Canadian company law and the common law of Antigua and Barbuda is derived in part from comparatively limited judicial precedent in Antigua and Barbuda, as well as from English common law, which has persuasive, but not binding, authority on a court in Antigua and Barbuda.
The rights of our shareholders and the fiduciary responsibilities of our directors under Antigua and Barbuda law are not as clearly established as they would be under statutes or judicial precedents in the United States. Among other things, Antigua and Barbuda has a less developed body of securities laws as compared to the United States, and provides significantly less protection to investors. Further, Antigua and Barbuda’s body of securities law, and the experience of its courts in addressing corporate and securities law issues of a type often experienced by public companies, is likely less developed than that of some of the other jurisdictions where publicly traded China-based companies are incorporated, such as the Cayman Islands.
It may be difficult or impossible for you to bring an action against us or our directors or officers in Antigua and Barbuda courts or to enforce or protect your rights under U.S. securities laws or otherwise. Even if you are successful in bringing an action of this kind, you may be unable to enforce a judgment against our assets or the assets of our directors and officers under the laws of Antigua and Barbuda.
There is doubt as to whether Antigua and Barbuda courts would enforce judgments of United States courts obtained in actions against us or our directors or officers that are predicated upon the civil liability provisions of the Securities Act, or in original actions brought against us or such persons predicated upon the Securities Act. There is no treaty in effect between the United States and Antigua and Barbuda providing for such enforcement, and there are grounds upon which Antigua and Barbuda courts may not enforce judgments of United States courts. In addition, Antigua and Barbuda corporations may not have standing to initiate a shareholder derivative action before the federal courts of the United States.
PRC courts may recognize and enforce foreign judgments in accordance with the PRC Civil Procedures Law based either on treaties between the PRC and the country where the judgment is made or on reciprocity between jurisdictions. If there are no treaties or reciprocity arrangements between the PRC and a foreign jurisdiction where a judgment is rendered, matters relating to the recognition and enforcement of the foreign judgment in the PRC may be resolved through diplomatic channels. The PRC does not have any treaties or other arrangements with the United States or Antigua and Barbuda that provide for the reciprocal recognition and enforcement of foreign judgments. As a result, it is generally difficult to enforce in the PRC a judgment rendered by a U.S. or Antigua and Barbuda court.
As a result of all of the above, as well as the fact that substantially all of our property, assets and operations are located in China and all of our major shareholders, directors and officers and substantially all of their assets are located outside of the United States, you may be unable to protect your shareholder interests through actions against us or our management,officers, directors or major shareholders.
We may be adversely affected by the final outcome of the administrative proceedings brought by the SEC against Ernst & Young Hua Ming LLP and other accounting firms in China.
In December 2012, the SEC initiated administrative proceedings against the China affiliates of five accounting firms, including our independent registered public accounting firm, Ernst & Young Hua Ming LLP, alleging that they refused to produce audit work papers and other documents related to certain China-based companies under investigation by the SEC for potential accounting fraud, and thus violated U.S. securities laws and SEC rules and regulations. On January 22, 2014, an SEC administrative law judge ruled in favor of the SEC, issuing an initial decision which censured each of the accounting firms for failure to provide their audit work papers to the SEC and ordered a six-month suspension of Ernst & Young Hua Ming LLP’s and the other China-based affiliates of the Big Four accounting firms’ right to practice before the SEC. On February 12, 2014, four of these China-based accounting firms appealed to the SEC against this decision. In February 2015, each of the four China-based accounting firms agreed to a censure and to pay a fine to the SEC to settle the dispute and avoid suspension of their ability to practice before the SEC.
The firms’ ability to continue to serve all their respective clients is not affected by the settlement. The settlement stays the current proceeding for four years, during which time the firms are required to follow detailed procedures to seek to provide the SEC with access to Chinese firms’ audit documents via China Securities Regulatory Commission. If a firm does not follow the procedures, the SEC could impose penalties such as suspensions, or it could restart the administrative proceedings or commence a new, expedited administrative proceeding against the non-compliant firm. The settlement did not require the firms to admit to any violation of law and preserves the firms’ legal defenses in the event the administrative proceeding is restarted.
In the event that the SEC restarts the administrative proceedings, depending upon the final outcome, listed companies in the United States with major PRC operations may find it difficult or impossible to retain auditors in respect of their operations in the PRC, which could result in financial statements being determined to not be in compliance with the requirements of the Exchange Act, including possible delisting. Moreover, any negative news about the proceedings against these audit firms may cause investor uncertainty regarding China-based, United States-listed companies and the market price of our common shares may be adversely affected.
If, as a result of this or any other action, the SEC suspends the right of Ernst & Young Hua Ming LLP to practice before the SEC, our ability to file financial statements in compliance with SEC requirements could be impacted. If none of the China-based auditors are able to continue to act as auditors for Chinese companies listed in the U.S., we may not be able to meet the reporting requirements under the Exchange Act, which may ultimately result in our deregistration by the SEC and delisting from the NASDAQ Stock Market, which would substantially reduce or effectively terminate the trading of our common shares in the United States. Moreover, any negative news about the proceedings against these audit firms may erode investor confidence in China-based, United States listed companies and the market price of our common shares may be adversely affected.
We and our investors may be adversely affected by the inability of the Public Company Accounting Oversight Board, or PCAOB, to carry out inspections of Ernst & Young Hua Ming LLP and other accounting firms in China.
Under the Sarbanes Oxley Act, auditors of companies whose shares are publicly traded in the United States, including our independent registered public accounting firm, Ernst & Young Hua Ming LLP, are required to register with PCAOB and to undergo regular inspections by PCAOB to assess compliance with applicable U.S. legal and accounting professional standards. As PCAOB is currently unable to conduct inspections in China, Ernst & Young Hua Ming LLP has not yet been inspected by PCAOB. PCAOB inspections of other audit firms in other jurisdictions have identified deficiencies in the audit and quality control procedures of those firms, which may be addressed to improve future audit quality. The inability of PCAOB to conduct inspections of independent registered public accounting firms operating in China makes it more difficult to evaluate the effectiveness of our auditor’s audit or quality control procedures. As a result, investors in our common shares may have less confidence in our publicly reported financial information and procedures and the quality of our financial statements.
In addition, PCAOB may choose to impose sanctions or take other actions against Ernst & Young Hua Ming LLP, including suspending or revoking Ernst & Young Hua Ming LLP’s registration with PCAOB. If Ernst & Young Hua Ming LLP and other China-based auditors are unable to maintain registration with PCAOB, we may be unable to meet the ongoing reporting requirements under the Exchange Act, which ultimately may result in the termination of the registration of our common shares and ordinary shares under the Exchange Act or the delisting of our common shares from NASDAQ, or both, which would substantially reduce or effectively terminate the trading of our common shares in the United States.
ITEM 4. | Information on the Company |
A. | History and Development of the Company |
Our legal and commercial name is Sinovac Biotech Ltd. Our principal executive offices are located at No. 15, Zhi Tong Road, Zhongguancun Science & Technology Park, Changping District, Beijing 102200, PRC. Our telephone number at this address is +86-10-5693-1800. Our registered address is located at The Colony House, 41 Nevis Street,the office of APN Corporate and Management Services Limited, Unit #4 Bryson’s Complex, Friars Hill Road, St. John’s, in Antigua and Barbuda.Antigua. Our agent for service of process in the United States is Law Debenture Corporate ServicesCogency Global Inc., located at 801 2nd Avenue, Suite 403,122 East 42nd Street, 18th Floor, New York, NY 10017.
10168.
We are a holding company and conduct our business in China through our 73.09% majority-owned subsidiary Sinovac Beijing, our wholly owned59.24% majority-owned subsidiary Sinovac R&D,LS, our 67.86%68% majority-owned subsidiary Sinovac Dalian, and our wholly owned subsidiaries Sinovac Biomed, Sinovac Hong Kong and Sinovac Hong Kong.Biotech (Singapore) Pte. Ltd. (“Sinovac Singapore”). Sinovac Beijing was incorporated on April 28, 2001, Sinovac R&DLS was incorporated on May 7, 2009, Sinovac Dalian was established on January 19, 2010, Sinovac Biomed was incorporated on April 16, 2015, and Sinovac Hong Kong was incorporated on October 21, 2008.
2008 and Sinovac Singapore was incorporated on August 6, 2020.
We were incorporated in Antigua and Barbuda on March 1, 1999 as an Antiguan company with limited liability under the laws of Antigua and Barbuda.Barbuda pursuant to the International Business Corporations Act. Before we adopted our current name on October 21, 2003, we were called Net-Force System Inc. and were primarily engaged in the online gaming business. We were quoted on the OTC Bulletin Board on February 21, 2003. In September 2003, we issued ten million new shares to Lily Wang, one of our then principal shareholders to acquire a 51% equity interest in Sinovac Beijing. Ms. Wang had contracted to purchase these shares from certain of Sinovac Beijing’s then shareholders for cash immediately before the above 51% share transfer. However, this 51% equity interest in Sinovac Beijing was transferred to us directly from those shareholders and was recorded under applicable PRC law transfer documents as a cash transaction. Lily Wang was responsible for paying the cash to those shareholders. The transfer of the Sinovac Beijing equity interest to us was registered and approved by PRC government authorities in August 2004. In September 2004, we acquired an additional 20.6% equity interest in Sinovac Beijing for approximately $3.3 million in cash. In October 2011, we further acquired an additional 1.53% equity interest in Sinovac Beijing by contributing the dividends declared to Sinovac Hong Kong but unpaid in amount of RMB18.6 million ($2.9 million). We currently own 73.09% of the equity interests in Sinovac Beijing and Sinobioway Medicine owns a 26.91% interest.
In January 2004, we entered into a share purchase agreement with Heping Wang and issued him 3.5 million of our common shares and a promissory note in the amount of $2.2 million to acquire from him a 100% equity interest in Tangshan Yian. Mr. Wang had contracted to purchase these shares from Tangshan Yian’s then two shareholders immediately before the above 100% share transfer. However, this 100% equity interest in Tangshan Yian was transferred to us directly from those shareholders and was recorded under applicable PRC law transfer documents as a cash transaction. Heping Wang was responsible for paying the cash to the two shareholders. The transfer of the Tangshan Yian equity interest by Mr. Wang to us was registered and approved by PRC government authorities in November 2004.
In the first quarter of 2008, we issued and sold an aggregate of 2.5 million common shares at $3.90 per share to Sansar Capital Management. We received approximately $9.75 million in gross proceeds from this private placement of our common shares.
In October 2008, we established Sinovac Hong Kong, a wholly owned subsidiary focused primarily on registering and distributing current and newly-developed vaccine products in Hong Kong and exporting our products abroad. In addition, Sinovac Hong Kong seeks research and development collaboration opportunities with third parties in Hong Kong.
In May 2009, Sinovac R&DLS was incorporated with a registered capital of $5 million. In June 2016, our board of directors approved an additional capital contribution of $4.6 million, by us. To date, we have invested RMB10.0 million (or $1.44 million) with the remaining part to be provided in due course.
which has been fully provided.
In November 2009, we entered into ana joint venture agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, we established Sinovac Dalian which focuses on the research, development, manufacturing and commercialization of live attenuated vaccines, such as varicella and mumps vaccines for human use. Pursuant to the joint venture agreement, we made an initial cash contribution of RMB60.0 million ($9.39.2 million) in exchange for a 30% equity interest in Sinovac Dalian and Dalian Jin Gang Group made an asset contribution of RMB140.0 million ($21.621.5 million), including manufacturing facilities, production lines and land use rights, in exchange for the remaining 70% interest in Sinovac Dalian.
In December 2010, we purchased an additional 25% equity interest in Sinovac Dalian from Dalian Jin Gang Group for consideration of RMB50.0 million ($7.7 million). In 2014, the board of directors passed a resolution to increase our capital contribution to Sinovac Dalian in the amount of RMB80.0 million ($12.812.3 million), which willaimed to increase Sinovac’s equity ownership from 55% to 67.86%. RMB50.0 million ($7.7 million) was initially provided through foreign debt with the expectation of a debt to equity swap of the total amount after the remaining RMB30.0 million ($4.6 million) is provided to Sinovac Dalian. In 2016, an additional RMB30.0 ($4.6 million) million was made to Sinovac Dalian through foreign debt and subsequently the debt to equity swap for a total of RMB80.0 million ($12.3 million) was completed. In October 2016, our equity ownership in Sinovac Dalian increased to 67.86%.
In February 2010, we closed a public offering of our common shares. We issued and sold 11.5 million common shares at $5.75 per share. We received net proceeds of approximately $61.8 million, after deducting underwriting discounts and commissions and offering expenses payable by us.
payable.
In 2013, we increased the capital investment to Tangshan Yian with the total amount of $4 million, which we lent to Tangshan Yian in 2010. In the same year, we lent Tangshan Yian $1 million to be used for sales and marketing spending and other corporate purposes and operational activities. In December 2015, Sinovacwe entered into an equity interest transfer agreement with Beijing Kuai Le Xing Biotech Co., Ltd. to transfer Sinovac’sour 100% equity interest in Tangshan Yian Biological Engineering Co., Ltd. to Beijing Kuai Le Xing Biotech Co., Ltd. for consideration of RMB13.0 million ($1.92.0 million). As of the date of this annual report, we have received RMB11.0 million ($1.7 million) and the remaining RMB2.0 million ($0.3 million) is receivable from Beijing Kuai Le Xing Biotech Co., Ltd. The disposal of Tangshan Yian was completed in February 2016. As a result, Tangshan Yian’s operating results and cash flows are presented as discontinued operations in Sinovac’s financial results, and Tangshan Yian’s assets and liabilities are presented as held for sale in Sinovac’s financial results.
In April 2015, Sinovacwe established Sinovac Biomed, Co., Ltd., which is 100% owned by Sinovac Biotech (Hong Kong) Ltd.Hong Kong. Sinovac Biomed Co., Ltd. focuses on the distribution of vaccine products as well as providing consulting services in the vaccination industry.
In March 2016, we adopted ourthe Rights Plan.Agreement. Pursuant to ourthe Rights Plan,Agreement, subject to limited exceptions, upon (i) a person or group obtaining ownership of 15% or more of our common shares or (ii) the commencement or announcement of an intention to make a tender offer or exchange offer, the consummation of which would result in the beneficial ownership by a person or group of 15% or more of our common shares, in each case, without the approval of our board of directors, each Right will entitle the holders, other than the Acquiring Person, to buy, at an exercise price of $30.00, one one-thousandth of a share of our newly created series A junior participating preferred shares or the Series(the “Series A Preferred Shares.Shares”). Holders are entitled to receive, in lieu of each one one-thousandths of a Series A Preferred Share, common shares having a market value at that time of twice the Right’s exercise price. Our board of directors is entitled to redeem the Rights at $0.001 per Right at any time before the Rights are exercisable. We refer to the person who acquired 15% or more of the outstanding common shares of the CompanySinovac Antigua as the “Acquiring Person.” In March 2017, we amended our Rights Plan to extend its term for a 12-month period and, in March 2018, we amended it to extend its term for an additional 12-month period. In June 2017, we amended our Rights Plan in connection with the execution of the Amalgamation Agreement. As described above, on March 5, 2018, the CompanySinovac Antigua filed a lawsuit in the Court of Chancery of the State of Delaware seeking a determination whether the Shareholder Group had triggered ourthe Rights PlanAgreement by forming a group holding approximately 45% of the Company’sSinovac Antigua’s outstanding shares, in excess of the plan'splan’s threshold of 15%, and acting in concert prior to the 2017 AGM.
On February 18, 2019, after reviewing the judgment of the Antigua Court of December 19, 2018 and considering all additional facts known to the board of directors, our board of directors determined that the Collaborating Shareholders became Acquiring Persons as defined under the Rights Agreement, and that their conduct resulted in a Trigger Event under the Rights Agreement. As a result, the Rights held by the Collaborating Shareholders were deemed void.
On June 26, 2017, we entered into the Amalgamation Agreement with Parent and Amalgamation Sub, a wholly owned subsidiary of Parent. Pursuant to the AmalgamationRights Agreement, Parentthe board of directors elected to exchange each valid and outstanding Right held by Sinovac Antigua’s shareholders (not including the Collaborating Shareholders) for an Exchange Share. The total Exchange Shares to be received by any holder will acquire Sinovac Biotech Ltd. for cash consideration equal to $7.00 per common share. Subjectbe rounded up to the termsnearest whole common share and conditionsrounded down to the nearest whole Series B preferred share. On February 22, 2019, in order to facilitate the Exchange, approximately 27.8 million Common Shares and approximately 14.6 million Series B Preferred Shares were issued into a trust for the benefit of the Amalgamation Agreement, at the effective timeholders of the Amalgamation, Amalgamation Sub will be amalgamated with and into Sinovac Biotech Ltd., with Sinovac Biotech Ltd. continuing as the surviving corporation and a wholly owned subsidiary of Parent and each of our common shares issuedvalid and outstanding immediately prior toRights (not including the effective timeCollaborating Shareholders). As of the Amalgamation will be cancelledclose of trading in consideration for the right to receive $7.00 per common share in cash, without interest and net of any applicable withholding taxes, except for (i) 6,049,500 common shares held by Mr. Weidong Yin and 10,780,820 common shares held by SAIF, (ii) common shares held by Parent, Parent’s affiliates, or Sinovac Biotech Ltd. or any of its subsidiaries, which common shares, in each case, will be canceled without payment of any consideration or distribution therefor and (iii) common shares owned by holders who have validly exercised and not effectively withdrawn or lost their rights to dissent fromUnited States on February 22, 2019, 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), or the IBCA, which common shares will be cancelled at the effective time of the Amalgamation forRights converted into the right to receive the fair value of suchExchange Shares and will no longer trade with the common shares, determined in accordance withand will not otherwise trade on any securities market.
In February 2019, we amended and restated the provisionsRights Agreement. Pursuant to the amended and restated Rights Agreement, subject to limited exceptions, upon (i) a person or group obtaining ownership of Section 191(4)15% or Section 195(2)more of the IBCA, as applicable. Immediately followingaggregate total of our common shares and Series B Preferred Shares then issued and outstanding or (ii) the Amalgamation, Parentcommencement or announcement of an intention to make a tender offer or exchange offer, the consummation of which would result in the beneficial ownership by a person or group of 15% or more of the aggregate total of our common shares and Series B Preferred Shares then issued and outstanding, in each case, without the approval of our board of directors, each Right will be beneficially owned byentitle the Buyer Consortium.
holders, other than the acquiring person, to buy, at an exercise price of $20.00, one one-thousandth of a share of our newly created series C junior participating preferred shares (the “Series C Preferred Shares”). Holders are entitled to receive, in lieu of each one one-thousandths of a Series C Preferred Share, common shares and/or Series B Preferred Shares having a market value at that time of twice the Right’s exercise price. Our board of directors acting uponis entitled to redeem the unanimous recommendationRights at $0.001 per Right at any time before the Rights are exercisable. We refer to the person who acquired 15% or more of the Special Committee, unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that our shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.
The Amalgamation is subject to customary closing conditions, including approval by an affirmative vote of holders of ouroutstanding common shares representing at least two-thirdsor Series B Preferred Shares of Sinovac Antigua as the shares present“acquiring person.” In February 2020 and voting in person or by proxy as a single class at a meeting of our 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. If completed, the Amalgamation will result in Sinovac Biotech Ltd. becoming a privately-held company and our common shares will no longer be listed on NASDAQ.
On June 28, 2017,2021, we received a written proposal, or the Sinobioway Proposal, from a consortium, or the Sinobioway Consortium, comprising (i) PKU V-Ming (Shanghai) Investment Holdings Co., Ltd., (ii) Shandong Sinobioway Biomedicine Co., Ltd., (iii) CICC Qianhai Development (Shenzhen) Fund Management Co., Ltd., (iv) Beijing Sinobioway Group Co., Ltd., (v) CITIC M&A Fund Management Co., Ltd., (vi) Heng Feng Investments (International) Limited and (vii) Fuerde Global Investment Limited, pursuant to which the Sinobioway Consortium proposed to acquire the Company in a transaction, or the Sinobioway Transaction, for cash consideration equal to $8.00 per common share. During the course of the following three months, the Special Committee and its advisors sought to clarify the terms of the Sinobioway Proposal, including the financing of the Sinobioway Transaction, and the likelihood of consummating the Sinobioway Transaction, with the Sinobioway Consortium and its advisors. In late October 2017, the Special Committee determined, after consultation with its advisors, that negotiations with respect to the Sinobioway Proposal were not permitted under the Amalgamation Agreement, based on the information provided by the Sinobioway Consortium prior to such determination.
On March 26, 2018, wefurther amended the Amalgamationamended and restated Rights Agreement to extend its termination date to April 26, 2018.term until February 2022.
On March 6, 2019, the Delaware Chancery Court entered a status quo order providing that Sinovac Antigua not distribute any of the Exchange Shares from the trust until the final disposition of the pending Delaware litigation or further order of the Court. On April 26,4, 2019, the Eastern Caribbean Supreme Court, Court of Appeal issued an order that restrains Sinovac Antigua from taking further action under the Rights Agreement, including the distribution of the previously issued Exchange Shares to the holders of valid Rights, until the conclusion of 1Globe Capital, LLC’s appeal of the December 19, 2018 Judgment of the Antigua Court. On April 8, 2019, the Delaware Chancery Court stayed the Delaware litigation pending the outcome of 1Globe’s appeal of the Antigua Judgment. 1Globe’s appeal of the Antigua Court’s Judgment was heard on September 18, 2019, and the appeal decision is pending as of the date of this annual report. See “Legal and Administrative Proceedings” for additional information.
In May 2020, Prime Success and Vivo Capital invested $15 million in our wholly owned subsidiary, Sinovac LS, to further the development of CoronaVac. The two investors each loaned $7.5 million in the form of a convertible loan that bore interest, or, at the investor’s election, converted into 7.5% of the total equity interest of Sinovac LS. Later each of Prime Success and Vivo Capital exercised its right to convert its convertible loan into 7.5% of the total equity interests of Sinovac LS. After the investment made by Sino Biopharmaceutical Limited as described below, Prime Success and Vivo Capital each holds approximately 6.3% stake in Sinovac LS.
On August 6, 2020, we established Sinovac Singapore, a wholly owned subsidiary focuses primarily on registering and distributing current and newly-developed vaccine products in Singapore and exporting our products abroad. In addition, Sinovac Singapore seeks research and development collaboration opportunities with third parties in Asia.
In November 2020, we increased our equity ownership of Sinovac Dalian from 67.86% to 68%, by converting RMB46.6 million ($7.0 million) debt into equity.
In December 2020, Sino Biopharmaceutical Limited, an innovative research and development driven pharmaceutical conglomerate in China, through its affiliates, invested approximately $500 million in exchange for approximately 15% equity interest in Sinovac LS in funding for further amendeddevelopment, capacity expansion and manufacturing of the Amalgamation AgreementCoronaVac. After this investment, our equity ownership of Sinovac LS decreased to extend its termination date to May 26, 2018.
59.24%.
For additional information regarding our principal capital expenditures, see “— D. Property, Plants and Equipment.Equipment” and “Item 5. Operating and Financial Review and Prospects —B. Liquidity and Capital Resources — Capital Expenditures.”
The SEC maintains an Internet site that contains our reports, proxy and information statements, and other information that we filed electronically with the SEC at http:// www.sec.gov.
Investor inquiries should be directed to us at the address and telephone number of our principal executive offices set forth above. Our website ishttp://www.sinovac.com. The information contained on our website does not form part of this annual report.
B. | Business Overview |
We are a fully integrated China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including, without limitation, hepatitis A, hepatitis B, hand foot and mouth disease (“HFMD”) caused by enterovirus 71,EV71, seasonal influenza, H5N1 and H1N1 pandemic influenza, coronavirus, varicella and mumps. In 2002, we launched our first product, Healive, which was the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. In 2005, we received regulatory approvals for the production of Bilive in China, a combined hepatitis A and B vaccine, and Anflu, a split viron influenza vaccine. In April 2008, we received the regulatory approval for the production in China of our whole viron H5N1 pandemic influenza (avian flu) vaccine, which is the only vaccine approved for sale to the Chinese national vaccine stockpiling program.
In September 2009, we were granted a production license for Panflu.1, which was the first approved vaccine in the world against the influenza A H1N1 virus (swine flu). In December 2011, Sinovac Dalian obtained the production license from the CFDANMPA for its mumps vaccine product and launched the mumps vaccine in late 2012. In December 2015, CFDANMPA issued the new drug certificate and production license for Inlive, our EV71 vaccine, and invaccine. In January 2016, CFDANMPA issued the GMP certificate. certificate and Inlive, our EV71 vaccine, was commercially launched in China in June 2016. In February 2021, NMPA granted a conditional marketing authorization for CoronaVac, our COVID-19 vaccine in individuals aged 18 and above. As of the date of this annual report, CoronaVac is being used under emergency use approval in Indonesia, Brazil, Turkey and Chile and we are also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximize global accessibility and affordability of the COVID-19 vaccine.
Our pipeline consists of various vaccine candidates in the pre-clinical and clinical development phases in China. We obtained the approvals to conduct clinical trials of PPV, pneumococcal conjugate vaccine, rubella vaccine, varicella vaccine, sIPV, and quadrivalent influenza vaccine (“QIV”) in May 2014, January 2015, December 2014, October 2015, November 2015 and in November 2016, respectively.
And the new drug applications for PPV, sIPV and QIV were received by NMPA in June 2017, January 2019 and March 2019, respectively. NMPA approved and issued a product license for our varicella vaccine, QIV vaccine and PPV vaccine in December 2019, June 2020 and December 2020, respectively. We initiated the development of CoronaVac, an inactivated vaccine against COVID-19, on January 28, 2020 and began rolling submission to NMPA since September 2020 and NMPA carried out rolling reviews when the submission was made. On February 5, 2021, NMPA granted a conditional marketing authorization to us for CoronaVac in individuals aged 18 and above.
Our Products
We specialize in the sales, marketing,research, development, manufacturing and developmentcommercialization of vaccines for infectious diseases with significant unmet medical need. Set forth below is a chart that outlines our current marketed products and those that we have developed or are developing.
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| Our Panflu whole viron pandemic influenza vaccine did not undergo phase III clinical trials because none were required by the relevant authorities in order to receive regulatory approval. |
(2) | Our Panflu split viron pandemic influenza Vaccine did not undergo phase III clinical trials because none were required by the relevant authorities in order to receive regulatory approval. |
(3) | Our mumps vaccine did not undergo clinical trials because none were required by the relevant authorities. |
(4) | Our COVID-19 vaccine, CoronaVac, has been granted the conditional marketing authorization in China. In other countries outside China, CoronaVac has been granted either the emergency use approval or conditional marketing authorization. |
• | Healive. In May 2002, we obtained the final PRC regulatory approval for the production of Healive, the first inactivated hepatitis A vaccine developed in China. The hepatitis A virus, which is endemic in China and other developing countries, primarily impacts the liver by causing it to swell and preventing it from functioning properly. The disease is highly contagious and can be spread by close personal contact, |
• | Bilive. In June 2005, we obtained the final PRC regulatory approval for the production of Bilive, the first combined inactivated hepatitis A and B vaccine developed and marketed in China. Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, which we manufacture, and recombinant (yeast) hepatitis B surface antigen, which we source from a third-party supplier. Recipients under China’s vaccination program must privately pay for Bilive vaccinations. Bilive is designed for boost immunization or for users in the private-pay market who prefer the convenience of one inoculation rather than two. Similar to hepatitis A, hepatitis B is endemic in China, a major disease worldwide and a serious global public health issue. A substantial percentage of people infected with the hepatitis B virus carry chronic or lifelong infections. The chronically infected are at a high risk of death from cirrhosis of the liver or liver cancer. We are the only supplier in China that produces a combined inactivated hepatitis A and B |
• | Anflu. In October 2005, we received the final approval from |
Mediterranean region.
• | Panflu. In April 2008, we were granted a production license for Panflu by |
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Split viron pandemic influenza vaccine. Our split viron pandemic influenza vaccine has been developed in conjunction with our whole viron pandemic influenza vaccine. Split viron vaccines are considered to have a better safety profile than whole viron vaccines, both of which are for the governmental stockpiling program. This product has been developed to address the needs of young children, who may be more susceptible to adverse reactions to whole viron pandemic influenza vaccine than to a split viron vaccine. In November 2011, we were granted the production license of split viron pandemic influenza vaccine that is to be used among the teenagers aged from 12 to 17. |
• | Panflu.1. In September 2009, we were granted a production license for Panflu.1 by the NMPA. Panflu.1 is the first approved vaccine in the world against the influenza A H1N1 virus. We started to sell Panflu.1 in September 2009 but has not generated revenue since 2011, and Panflu.1 is not likely to generate revenues in the foreseeable future. Panflu.1 is also registered for sale in Mexico. |
• | Mumps vaccine. Mumps is a viral disease of the human species caused by mumps virus, which poses a significant threat to human health in the developing countries. In September 2012, we were granted a production license for mumps vaccine. We began to sell mumps vaccine in December of 2012. |
• | Inlive. EV71 causes HFMD among children under ten years old. HFMD is a common and usually mild childhood disease; however, HFMD caused by EV71 has shown a higher incidence of neurologic involvement, and a higher acute fatal incidence. There have been a number of outbreaks of HFMD caused by EV71 in the Asia-Pacific region since 1997 including |
Our pipeline consists of vaccine candidates in the clinical and pre-clinical development phases in China, as follows:
• |
Varicella vaccine. Varicella is a highly contagious infectious disease caused by the varicella-zoster virus (herpesvirus 3, Human). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei and is characterized by the appearance on the skin and mucous membranes of successive crops of lesions that are easily broken and become scabbed. Varicella is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. |
• | Pneumococcal polysaccharide vaccine (“PPV”). PPV is |
• | Quadrivalent influenza vaccine (“QIV”). Different from the trivalent influenza vaccine, which includes an influenza A H1N1 virus, an influenza A H3N2 virus and one influenza B virus, QIV is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. These two very different lineages of B viruses circulate during most seasons. Adding another B virus to the vaccine aims to give broader protection against circulating flu viruses. We initiated the development of a QIV in May 2013. Following the completion of preclinical studies, we applied for the clinical license from NMPA. The approval to conduct human clinical trial was issued by NMPA in November 2016. Phase III clinical trial has been completed. The preliminary results of the phase III clinical trial showed that the vaccine is safe and immunogenic. The site inspection was completed in March 2020. On June 24, 2020, NMPA issued a product license for our QIV vaccine. |
• | COVID-19 vaccine (“CoronaVac”). We initiated the development of a vaccine against COVID-19 on January 28, 2020. The application for clinical trials was submitted to NMPA on March 13, 2020. NMPA implemented a concurrent review on the full submission and granted the approval for clinical trials on April 13, 2020. The phase I clinical trial commenced on April 16, 2020. The phase I and II human studies on |
healthy adults aged 18 to 59 and elderly adults aged 60 and above were conducted in China and enrolled 144 participants in the phase I trial and 600 participants in the phase II trial, with 743 participants receiving at least one dose of investigational product. Results from the randomized, double-blind, placebo-controlled phase I/II clinical trial on safety, tolerability and immunogenicity of CoronaVac were published in the Lancet Infectious Diseases on November 17, 2020. The phase I trial was conducted in a dose-escalating manner, in which participants were randomly separated 1:1 into two vaccination schedule cohorts, the days 0 and 14 cohort and days 0 to 28 cohort, and then randomly assigned to blocks within each cohort of low-dose CoronaVac (3 μg) or high-dose CoronaVac (6 μg). Within each block, participants were randomly assigned 2:1 to either two doses of CoronaVac or placebo. In the phase II trial, at screening, participants were randomly separated 1:1 into the same two vaccination schedule cohorts and then randomly assigned 2:2:1 to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. The study found that two doses of CoronaVac at different concentrations and using different dosing schedules were well tolerated and moderately immunogenic in healthy adults aged 18 to59 years. We started our first phase III trial on CoronaVac on July 21, 2020 in Brazil, and then in Turkey, Indonesia and Chile. In compliance with the principles of Good Clinical Practice (GCP), the trials were conducted with the vaccine candidate produced from the same lot and following the 0, 14 day schedule. There were a total of approximately 30,000 participants enrolled in the trial across those four countries. In Brazil, a phase III efficacy study conducted on healthcare worker only, who directly contact COVID-19 patients, shows an efficacy rate of 100.00% in preventing hospitalized, severe and fatal cases, 83.70% in preventing cases requiring medical treatment, and 50.65% overall efficacy rate. In Turkey, another trial on over 10,000 volunteers mainly among general population shows 100.0% efficacy rate against hospitalized cases and an overall 83.5% efficacy rate. We began rolling submission to NMPA since September 2020 and NMPA carried out rolling reviews when the submission was made. We were granted a conditional marketing authorization (CMA) by NMPA for CoronaVac in individuals aged 18 and above on February 5, 2021. As of March 31, 2021, CoronaVac has been granted either emergency approval or conditional marketing authorization by over 30 countries or regions. |
Our pipeline consists of vaccine candidates in the clinical and pre-clinical development phases in China, as follows:
• | Sabin Inactivated Polio |
the middle of 2021. An application of pre-qualification assessment by WHO was filed by us in January 2020 and site-inspection by WHO was conducted in February 2021. We expect a decision of such assessment in 2021.
Research and Development
We have established a leadership position in the research and development of vaccines in China. Since our inception, we have successfully developed and marketed Healive, Bilive, Anflu, Panflu, Panflu.1, mumps vaccine, Inlive, varicella vaccine, QIV and have made significant advances in the prevention of SARS.PPV. Please see “— Our Products.” We believe our R&D capabilities provide us with a key competitive advantage. We intend to focus our research and development efforts on developing vaccines for infectious diseases with significant unmet medical needs, as well as the vaccine products with extensive market demand in China and other developing countries.
COVID-19 is spreading globally, and the whole world is facing an unprecedented public health crisis. We commenced the development of the COVID-19 vaccine at the end of January 2020. Our R&D team have completed comprehensive preclinical studies and clinical trials in partnership with leading academic research institutes in China and overseas. Our COVID-19 vaccine has been granted a conditional market authorization by NMPA on February 5, 2021.
In 2008, we restructured our R&D team in Beijing to better utilize our scientific and personnel resources. In 2009, we built an R&D center of approximately 13,300 square feet in the campus of our Beijing headquarters to meet our R&D demand. In 2011, we built a lab of 6,778 square feet, which is focused on maintaining quality control of our pipeline products.
In 2021, we plan to conduct pipeline product development in our new site in Daxing District of Beijing, where we produce CoronaVac.
In order to achieve our R&D goal, part of our R&D strategy is to focus on in-house development and to establish collaborations with domestic and international partners on technology and viruskey material licensing, including but not limit to strains licensing.and cell lines. We have entered into
collaborations with a group of leading universities, colleges and research institutes that have strong vaccine research capabilities and proven track records in China. In most cases, we will own the commercial rights to the products that result from our existing R&D strategic collaborations.
The investment in R&D is one of our strategies, which, we believe, will ensure our future growth. Our research and development expenses were $20.5$48.8 million, $12.6$24.3 million and $9.5$21.9 million in 2017, 20162020, 2019 and 2015,2018, respectively. We have obtained financial support from the PRC government to conduct preclinical and clinical research of vaccines for government-sponsored programs.
Sales and Marketing
Our sales strategy is to maintainincrease our market share and enhance our competitive advantage in the private vaccine sales market in China while building on this strength to push government to expand market sharesize in the government-paid market.
The overall vaccine market improved in 2017, following the impact of negative publicity regarding the incident where vaccines were illegally sold We also intend to establish our presence, increase our sales to international markets and distributed in Shandong province and other provinces around China in 2016. Total salesenhance awareness of our regular products increased by 164.0% year over year.outside China.
We primarily rely on our own sales force to sell our products directly to CDCs in the private market before 2017. During 2017,In 2018, our sales model was changed from direct sales by in-house teamtotally transformed to a collaborative model between our sales team and third party promoting companies. These changethird-party marketing agents. We have formed a marketing management team, strengthened the compliance management to third-party marketing agents, and expanded market coverage, improved market competition, and improved the quality of business model will combine the advantages of wider coverage via the promoting companies with our internal scientific expertise to provide bettercustomer services to our customers.through professional and academic promotion activities. As of December 31, 2017,2020, our in-houseinternal sales and marketing team consisted of 66 staff members assigned to five regions coveringcovered 2,171 district CDC customers in 31 provinces and four municipal cities throughout China. And we have entered into collaboration with 44 third party promotion companies, who helped promote business among CDCs. We still directly enter into sales agreements with CDCs each time a CDC places a purchase order. Pursuant toin China, representing an increase of 8.7% as of the sales agreements, CDCs agree not to re-sell our products to regions outside the territory the pertinent CDC covers administratively.end of year 2019. Our sales team still maintains stable relationshipsis mainly responsible for the maintenance of customer relationship at or above the provincial level, bidding access at the provincial level, the development of the public market, as well as product after-sales services and the support and management of third-party marketing agents. We cooperate with 48 third-party marketing agents, engaging approximately 1,000 marketing and promotional staff. The team of the third-party market agents carries out business with district CDC customers with our support in all aspects. In addition, we have taken the lead in placing commercial insurance compensation mechanism for abnormal response to vaccination nationwide in the private vaccine market to provide more professional services for CDC customers by providing them with technical supports and trainings in collaboration with promoting companies.consumers. We believe these efforts contributed to our reputation for quality and brand awareness in the Chinese vaccine market.
We intend to establish our presence, increaseIn 2020, 2019 and 2018, our sales to international marketsin China contributed 71.6%, 92.3% and enhance awareness93.7%, respectively, of our products outside of China. Our products are registered in several Asian countries as well as Latin American countries.total sales. As of December 31, 2017,2020, we had already exported some of our vaccine products to 1128 countries. Our products are being registered in 30 countries. In order to speed up the business globalization, progress, as well as strengthening our reputation for quality, we obtained WHO prequalification in December 2017 for our hepatitis A vaccine, or Healive. As of the date of this annual report, CoronaVac is being used under emergency use approval in Indonesia, Brazil, Turkey and Chile and we are also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximize global accessibility and affordability of the COVID-19 vaccine. We will continue to explore the globalization of our product portfolio and develop products targeting other potential international markets where we believe we can be successful.
Seasonality
Our business is highly seasonal. For example, the influenza season generally runs from November through March of the next year, and the largest percentage of influenza vaccinations is administered between September and November of each year. As a result, we expect to realize most of our annual revenues from Anflu during this period. We expect this seasonality in our business to contribute to significant quarterly fluctuations in our operating results. In the first quarter, our strong winter-season sales are usually offset by the slow-down of business during the Chinese New Year holiday season that effectively lasts more than half a month. During this holiday season, many businesses in China, including CDCs and most departments in hospitals, are either closed or substantially reduce the level of their activities. Please see “Item 3. Key Information — D. Risk Factors — Risks Related to Our Company — Our business is highly seasonal. This seasonality will contribute to our operating results fluctuating considerably throughout the year.”
Suppliers
We obtain the raw materials from local and overseas suppliers. We generally maintain at least two suppliers for each key raw material, with the exception of hepatitis B antigens we use for Bilive production. We source hepatitis B antigens entirely from Beijing Tiantan. Please see “Item 3. Key Information — D. Risk Factors — Risks Related to Our Company — If any of our third-party suppliers or manufacturers cannot adequately meet our needs, our business could be harmed.” Raw materials generally are in good supply and the prices we pay for them have remained stable. We target to maintain our gross margin in the event of rising raw materials costs by improving our production processes and technical methods.
Manufacturing, Safety and Quality Assurance
We have threefour manufacturing bases located in the Haidian, Changping and Changping DistrictsDaxing districts of Beijing and Dalian City of Liaoning province.
We have twothree upstream production facilities in Haidian District, Beijing for commercialized products. Our Healive and Bilive share the same production line, which has an aggregate annual capacity of 10 million doses. Our Anflu production line has an annual capacity of 815 million doses, which can also be used to produce 20 million doses of Panflu or Panflu.1 annually. Our PPV has an annual capacity of 5 million doses.
OurWe received GMP certificates for our Healive, Bilive and Anflu production facilities received their GMP certificates initially in March 2002, June 2005 and October 2005, respectively, and renewed their GMP certificates for another five years in 2008, 2010 and 2010, respectively.2018. The upstream production plants for our hepatitis vaccines and
flu vaccines in Haidian District have passed the new GMP certification and obtained the new GMP certificate on April 17, 2013, which was renewed on April 13, 2018.2018 for five years. Our hepatitis A vaccine production lines in both Shangdi site and Changping site passed GMP inspection by WHO for prequalification purpose in December 2017. Our upstream production line for PPV, with an annual production capacity of 55.0 million doses, was built in HaidianShangdi site in 2014.2014, which passed the GMP inspection in 2020.. As described above, a representative of Sinobioway Medicine and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and cut power to our Shangdi site. Due to the actions of the representative of Sinobioway Medicine, Sinovac Beijing was forced to destroy the affected products of hepatitis A vaccine and influenza vaccine and temporarily suspended production at the impacted facility in order to maintain product safety. Since the influenza vaccine is a seasonal product, there was no supply of Anflu for the flu season of 2018-2019. However, production of the hepatitis A vaccine resumed in fourth quarter of 2018 and production of the influenza vaccine resumed in March 2019. Our PPV production line passed the inspection by NMPA in June 2020 and production license was granted on December 2, 2020.
We have built a newOur production site in Changping District, Beijing which consists of a new filling and packaging line that complies with the new PRC GMP standards, the EV71 production facilities and a warehouse. The EV71 vaccine production line has a designed annual capacity of 20 million doses and was granted the GMP certificate in January 2016.2016 for five years. Our upstream production facilities of Sabin IPVsIPV were built in Changping in 2017 with an expected annual production capacity of 20 million doses.
We have built a new production site for CoronaVac in Daxing District, Beijing, in compliance with the new PRC GMP standards, and our CoronaVac production lines have an estimated annual capacity of 2 billion doses.
Our production site in Sinovac Dalian focuses on the research, development, manufacturing and commercialization of live-attenuated vaccines, such as varicella, mumps and combination vaccines containing measles, mumps, rubella, and/or varicella. Sinovac Dalian has received its GMP certificate (2010 version) from the CFDANMPA for its mumps vaccine in September 2012 and launched mumps vaccine, its first commercial product, in late 2012. The renewed GMP certificate issued by Food and Drug Administration of Liaoning Province was obtained on February 13, 2018, which will remain valid until February 12, 2023. The construction ofOur varicella vaccine production line was inspected by NMPA and a production line for the varicella vaccine is being completed.
license was granted in December 2019.
Each of our subsidiaries has its own quality assurance departments.department. The quality assurance department of each subsidiary plays a role to supervise the R&D, manufacturing, procurement, quality control, sales and marketing, logistics and plant construction of its owneach subsidiary under the guidance of relatingthe applicable regulations and guidelines. Regular training or seminars are organized among quality assurance departments of each subsidiarysubsidiaries to share and exchange knowledge and experiences.
Sinovac hasWe have built a pharmacovigilance system. Pharmacovigilance system, which includes organization structure, documentation, working procedures and SOPs. The organization structure indicates staff organization and their relevant duties and responsibilities. According to the requirements of the regulatory authorities, we regularly report the severe Adverse Event Following Immunization or AEFI,(“AEFI”) in time and regularly.. We summarize and analyze safety information coming from post-marketing surveillance, phase IV clinical trials, safety studies and literatures, and to submit the Periodic Safety Update Reports to the regulatory authorities regularly. Meanwhile, we are also required to assist the regulatory authorities to investigate on the AEFIs and provide related information as required.
With respect to compliance with environmental laws, we have also obtained the approval of the environmental impact assessment report from the Beijing Municipal Environment Protection Bureau for the construction plan of our facilities in Changping District, Beijing in 2011. We produce Bilive vaccine at our production facility for hepatitis A vaccine and produce Panflu and Panflu.1 vaccines at our production facility for seasonal flu or Anflu vaccine. According to the PRC Environmental Impact Assessment Law, after the approval of previous environmental impact assessment reports, if there is any material change in the nature, scale, location, production technology used and measures adopted to prevent damages to ecology, new environmental impact assessment reports need to be filed for approval. We have canceled the construction plan for our influenza vaccine production facility in Changping. A new environmental impact assessment report regarding the change was submitted to the relevant environment protection authorities and passed the government inspection in 2011. We also added a sIPV production facility to the Changping construction plan in 2016. The relevant environmental impact assessment report was submitted to the relevant government authorities and passed the government evaluation. The approval on such report was already obtained. The construction of sIPV has been completed, and we have completed the clinical trial. In addition, we have also obtained approval for the environmental impact assessment report for PPV production facility at our Shangdi site in 2014. In 2020, we obtained the approval for the environmental impact assessment report for the CoronaVac production facility.
Collaborations
In September 2015, Sinovac Dalian entered into a technology transfer and supply agreement with GSK,GlaxoSmithKline Biologicals SA (“GSK”), to use GSK’s measles seeds to develop combination vaccines containing measles for the China market. Under this agreement, GSK agreed to transfer its measles seeds, and provide reasonable assistance and relevant technical materials to Sinovac Dalian for developing and producing combination vaccines containing measles. The Company made aWe did not make any payment of $87,000 for purchasing measles seeds fromto GSK during the year ended December 31, 2017.
2020, 2019 and 2018.
On April 3, 2014, we entered into a non-exclusive license agreement with INTRAVACC, a governmental institute working under the Dutch Ministry of Public Health, Welfare and Sports, to develop and commercialize sIPV for distribution in China and other countries. We expect to develop and commercialize the vaccine in China first, as well as seeking regulatory approval in other countries.countries at the later stage. The agreement has a term of 50 years. Please see “— Our Products.”
We agreed to pay INTRAVACC a license fee of up to $2,406 million (€1.5 million) net of PRC withholding tax, including an entrance fee and milestone payments upon achievingachievement of specific milestones. We also agreed to pay royalty payments in a single digit percentage of net sales generated worldwide from the product or products developed under the license agreement. We recorded an entrance feea payment of $0.7$35,000 (€30,000) and $0.6 million (€0.5 million) excluding PRC withholding tax for the year ended December 31, 20142020 and 2018, as research and development expense. We also recorded $0.1 million (€0.1 million) for payment made to INTRAVACC for use of sIPV viral seeds in research and development expense for the year ended December 31, 2014. There was no expense incurred or paid to INTRAVACC for the year ended December 31, 2017 and 2015. We recorded a milestone fee of $0.6 million (€0.5 million) for the year ended December 31, 2016 as research and development expense.
2019.
We licensed from MedImmune, LLC or MedImmune,(“MedImmune”) certain rights to use patented reverse genetics technology pertaining to a virus strain used for the production of Panflu (H5N1). We have agreed to pay an upfront license fee and to pay milestone payments of up to an aggregate of $9.9 million upon the achievement of certain amount of cumulative net sales of licensed products in China (including Hong Kong and Macau), as well as royalty payments in single digits of net sales of the licensed products in China (including Hong Kong and Macau). On August 15, 2012, we entered into amendment agreementsamendments with MedImmune in respect of four of our patent license agreements with MedImmune to, among other things, extendextended the effectiveness term of each agreement to reflect revised termination dates between December 2015 and May 2021. We accrued license fee and royaltiesa royalty payment of $3.4 million at the end of 2011$9,000 in 2018, which werewas paid in 2012.2019. We did not makeaccrue any royalty payment in 2013 but made a $1.0 million royalty payment in May 2014. No royalties were incurred or paid for the year ended December 31, 2015,2020 and we accrued a royalty payment of $8,000 as of December 31, 2016, which was paid in 2017.2019.
In March 2009, we entered into a technology transfer agreement (with an amendment agreement entered into on December 14, 2011) with Tianjin CanSino Biotechnology Inc. or (“Tianjin CanSino, a third party company, to develop a 7-valent pneumococcal conjugate vaccine.Cansino”). According to the agreement, Tianjin CanSinoCansino will transfer the technology of arelated to pneumococcal vaccine to us and jointly develop the technology with us. The collaboration term under the technology transfer agreement is from the signing dateMarch 12, 2009 to eight years after the first salessale of the vaccine developed under the technology transfer agreement in the Chinese market.
Under thisthe terms of the technology transfer agreement, we agreed towill make milestone payments of up to $3 million and royalty payments ranging from 6% to 10% for theof net sales in the Chinese market.
Each of the future milestone payments is subject to certain conditions, including the PRC government approvals at different stages, which are uncertain. We also agreed to make royalty payments for eight years after the first sales of the vaccine developed under the technology transfer agreement in the Chinese market. The sales of the pneumococcal vaccine in the Chinese market are also subject to PRC government approval.China. Both parties agreed towill work together to develop international markets for the products. On November 9,17, 2009 and December 14, 2011, we entered into two amendments toamendment agreements were signed for the technologypayment of $0.3 million for the transfer of anotheran additional six serotypes and related technology to us for $0.3technology. As of December 31, 2020, we made total milestone payments of $1.2 million to develop a 13-valent pneumococcal conjugate vaccine. On($1 million under the agreement dated as of March 12, 2009 and $0.2 million under the amendment agreement dated as of December 14, 2011). The remaining milestone payments will be paid when we achieve each specific milestone, which includes obtaining clinical trials approval, completing clinical trials and achievement of desired results, and achievement of commercial sales.
In January 29, 2015, we entered into the third amendment to the technology transfer agreement dated March 12, 2009, and the first two amendment agreements datedas amended on November 17, 2009 and December 24, 2011.
2011, respectively. By entering into this third amendment, the technology transfer agreement was revisedamended to be a licensing agreement. The remaining milestone and royalty payments under the agreements weretechnology transfer agreement have been reduced. Both Sinovacwe and Tianjin CanSinoCansino are free to develop PCVpneumococcal vaccines or to collaborate with one other companycompanies for the same purpose. As ofWe did not make any payment in this regard for the years ended December 31, 2017, we made total milestone payments of $1.8 million ($1.0 million under the March 2009 agreement, $0.2 million under the November 20092020, 2019 and December 2011 amendments, and $0.6 million under the January 2015 amendments).2018.
OnIn August 18, 2009, we entered into a patent license agreement with the National Institutes of Health or NIH,(“NIH”), an agency of the United States Public Health Services within the Department of Health and Human Services. NIH has granted us a non-exclusive license to makeimport and use certain of its products.Rotavirus Strains and Monoclonal Antibodies (“Biological Materials”) to develop an oral rotavirus vaccine and produce the vaccine in commercial sales and launch into market. NIH has also granted us the right to use certain documentation associated informationwith the Biological Materials for this research and development project. The term of its licensed products. The collaboration termthe license under the patent license agreement is from August 18, 2009 to the later of (a) the expiration of all royalty obligations under the licensed rights where such rights exist and (b) eight years after the first commercial sale by us, unless the agreement is terminated earlier per the provisions included therein.
We agreed to pay NIH a license issue royalty of $0.1 million$80,000 upon execution of the agreement and a non-refundable minimum annual royalty of $8,000, and royalty payments on net sales ranging from 1.5% to 4.0%4% depending on the sales territory and the customers. We also agreed to pay NIH benchmark royalties of $0.3 million upon achieving each benchmark as specified in the patent license agreement, including completion of clinical trials, obtaining regulatory approval for marketing, and achievement of commercial sales. We recorded a license royalty of $1,000, $1,000 and $16,000 for the year ended December 31, 2020, 2019 and 2018, respectively, as research and development expenses.
In June 2020, we entered into a clinical development collaboration agreement with Instituto Butantan, a leading Brazilian producer of immunobiologic products, to advance the clinical trials of CoronaVac to phase III. Through the collaboration, Instituto Butantan sponsored the phase III clinical trials in Brazil. These series of agreements completed or to be completed between the parties help 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.
In August 2020, we signed two agreements with PT Bio Farma, a leading biopharmaceutical company in Indonesia, for the supply, local production and technology licensing in respect of CoronaVac. Under these agreements, we are committed to supply Bio Farma bulk vaccine to enable the latter to produce at least 140 million doses of CoronaVac in Indonesia.
In November 2020, we signed two agreements with KEYMEN Ilac Sanayi. Ve Tic. A.S. (“KEYMEN”), an active in supplier of pharmaceutical products in Turkey, for the supply, local production and technology and know-how licensing of CoronaVac. Under the agreements, our company and KEYMEN will cooperate to enable local filling and packaging from the bulk vaccine supplied by us in designated facilities in Turkey.
Competition
The pharmaceutical, biopharmaceutical and biotechnology industries both within China and globally are intensely competitive and are characterized by rapid and significant technological progress, and our operating environment is increasingly competitive. In 2010, the CFDANMPA increased the quality standard of some vaccine products by issuing a new version of Pharmacopeia. As a result, some vaccine products manufactured by multinational companies could no longer be sold in China. According to the CFDA,NMPA, there are approximately 40 vaccine companies in China, of which we believe approximately ten10 are our direct competitors.
Even with the advent of private medical and healthcare insurance programs in China and the government vaccine purchase program’s expanded vaccine list, most Chinese citizens must pay for vaccines by their own vaccines because these insurance programs do not typically cover vaccines and the government vaccine purchase program covers only infants and young children. We believe the consumer market for conventional products is health conscious yet price sensitive and accordingly would favor our products over both the cheaper but not enough highvaccines with lower quality vaccines provided by local manufacturers and comparable quality butthe more expensive vaccines with comparable quality manufactured by international competitors. Our competitors, both domestic and international, include large integrated multinational pharmaceutical, domestic state-owned entities and domestic private companies that currently engage in, have engaged in or may engage in, efforts related to the discovery and development of new biopharmaceuticals and vaccines. Many of these entities have substantially greater research and development capabilities and financial, scientific, manufacturing, marketing and sales resources than we do, as well asdo. They are also more experienceexperienced in research and development, clinical trials, regulatory matters, manufacturing, marketing and sales, although these advantages are not comprehensive.
sales.
Multiple vaccine products have been approved for salesales worldwide. Many of these vaccine products are marketed by our major competitors and are in the areas ofparticular for hepatitis A, hepatitis B, influenza and EV71.EV71 vaccine. Specifically, with respect to the inactivated hepatitis A vaccine, we consider Kunming Institute of Biological Product, Sanofi Pasteur and Merck Sharp & Dohme Corp. as key competitors in the China, market, and GlaxoSmithKline Biologicals and Merck Sharp & Dohme Corp. for the markets outside of China.
In China, according to the batch release numbers published by NIFDC, over 75% of hepatitis A vaccines released in China are live attenuated vaccine, another type of hepatitis A vaccine compared to inactivated version, which is the biggest competitor for inactivated hepatitis A vaccine. The live attenuated hepatitis A vaccine manufacturers include Kunming Institute of Biological Product,Medical Biology, Chinese Academy of Medical Sciences Pukang Biological Co., Ltd., and Changchun Institute of Biological Products and Changchun Changsheng Life Sciences Ltd.Products. With respect to the hepatitis A and B vaccines, we are the only company to supply hepatitis A and B vaccinewith this product in China.
With respect to the influenza vaccines, in China, we consider Hualan Biological Engineering Inc., and Changchun Institute of Biological Products Sanofi Pasteur S.A., Changchun Changsheng Life Sciences Ltd., Aleph Biological Co., Ltd. (Dalian Yalifeng)as key competitors in China, and multinational companies including GlaxoSmithKline Biologicals, Sanofi Pasteur S.A. as our major competitorscompetitor for the marketmarkets outside of China. With respect to the EV71 vaccines, we considered Kunming Institute of Biological ProductMedical Biology, Chinese Academy of Medical Sciences and China National Biotec Group Co., Ltd. as our key competitors in China as well as outside China. With respect to the COVID-19 vaccine, we consider China National Biotec Group, Pfizer and AstraZeneca as our key competitors. With respect to the varicella vaccine, we consider Changchun BCHT Biotechnology Co., Ltd. and Changchun Keygen Biological Products Co., Ltd. as key competitors in China. With respect to the 23-valent pneumococcal polysaccharide vaccine, we consider Chengdu Institute of Biological Products and Walvax Biotechnology Co., Ltd. as the key competitors in China.
We believe we enjoy a number of advantages over ourthe PRC domestic competitors and multinational competitors.competitors in China. Generally, we believe that the principal competitive factorsadvantage in the markets for our products and product candidates include:
• | safety and efficacy profile; |
• | brand reputation; |
• | product supply; and |
• | after-sales |
Intellectual Property and Proprietary Technology
Protection of our intellectual property and proprietary technology is important forto our business. We rely primarily on a combination of trademark, patent and trade secret protection laws in China and other jurisdictions, as well as employee and third-party confidentiality agreements to safeguard our intellectual property, know-how and our brand. Our ability to protect and use our intellectual property rights in the development and commercialization of our technologies and products, operate without infringing the proprietary rights of others and prevent others from infringing our proprietary rights is crucial to our continuedlong term success. We will be able to protect our products and technologies from unauthorized use by third parties only to the extent that they are covered by valid and enforceable patents, trademarks or copyrights, or are effectively maintained as trade secrets, know-how or other proprietary information.
We have a total of 5168 issued patents and a number of pending patent applications relating to our vaccines in China. Our hepatitis A vaccine and seasonal influenza vaccine and EV71 vaccine have five, three and eight issued patents for protection, respectively.
With respect to, among other things, proprietary know-how that is not patentable and processes for which patents are difficult to enforce, we rely on trade secret protection and confidentiality agreements to safeguard our interests. We believe that many elements of our vaccine products, clinical trial data and manufacturing processes involve proprietary know-how, technology or data that are not covered by patents or patent applications. We have taken appropriate security measures to protect these elements.such assets. We have entered into confidentiality agreements (which include, in the case of employees, non-competition provisions) with all our employees and many of our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements provide that all confidential information developed or made known to the individual or an organization or company during the course of the individual’sits relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances.circumstances permitted by such agreements. In the case of our employees, the agreements provide that all of the technology conceived by the individual during the course of employment is our exclusive property and require our employees to assign to us all of their inventions, designs and technologies they develop during their terms of employment with usonce the technology is conceived and cooperate with us to secure patent protection for these inventions if we wish to pursue such protection.
WeIn the past, we have relied on the administrative protection afforded to new drugs through the monitoring period provided by the CFDA in the past.NMPA. During the monitoring period, third party applications for manufacturing or importing the same drugdrugs are not accepted by the CFDA.NMPA. The administrative protection for Healive expired in December 2007 and Bilive expired in January 2008. TheCurrently, the administrative protection was no longer implemented in China. Instead, CFDANMPA implements a new drug monitoring period starting from the issuance of production license, aiming to collect safety data for further evaluation on new products of this kind commercialized in China.license. Our EV71 vaccine was granted a five-year new drug monitoring period and during whichthe monitoring period, no other company is able towill be approved to enter into a human clinical study of thisthe same kind of vaccine except thevaccine. Therefore, only three products from Kunming, CNBG and Sinovac have been approved in China. ThisThe monitoring period of our EV71 vaccine will expirehas expired in December 2020.
We maintain 2022 registered trademarks in China, including (i) Sinovac,“Sinovac”, (ii) Sinovac’s Chinese name and its logo, (iii) Healive,“Healive”, its Chinese name and its logo, (iv) Bilive“Bilive” and its Chinese name, (v) Anflu“Anflu” and its Chinese name, (vi) Panflu,“Panflu”, its Chinese name and its logo, (vii) PANFLU.1“PANFLU.1” and its Chinese name, (viii) “Inlive” and its Chinese name, of Inlive(ix) “EV71Vac” , (x) “EntV71” and (ix) EV71Vacits Chinese name, and EntV71. (xi) “CoronaVac” and its Chinese name.
We have registered and maintain “Sinovac” trademark in Canada, Malaysia, the Philippines, South Korea and Egypt. In the United States. WePhilippines, we have registered and maintain “Anflu”.
As our brand names “Sinovac” as trademarks under the “Madrid international trademark registration system,and “科兴” which can be usedare becoming more recognized in the member countriesvaccine market, we are working to maintain, increase and enforce our rights in the trademark portfolio. Since 2001, Sinovac Beijing has been using “科兴” (Kexing) as part of Madrid Union, including France, United Kingdom and Germany. Since the “Sinovac” trademark certificates of Columbia, India and Thailand have already expired, we now deal with their renewal procedures.
We currentlyits Chinese trade name. Sinovac Dalian began to use “科兴” (Kexing) as part of Sinovac Beijing’sits Chinese trade name in the PRC. We also use2010. Shenzhen Kexing successfully registered “科兴” (Kexing) as part of the Chinese trade name of Sinovac Dalian in the PRC. Shenzhen Kexing currently owns the “科兴” trademark registered in China for Class 5 (Pharmaceuticals) under the International Classification of Goods and Services.Services in 2001. To protect our interest in using “科兴” in our trade name,names, we applied to register “科兴” in China for Class 42 (Scientific & Technological Services & Research) in 2006 and the PRC Trademark Office of the State Administration for Industry and Commerce approved our application in 2010. TheAs of the date of this annual report, the “科兴” trademark registered and owned by Shenzhen Kexing has not been identified as “Well-known Trademark” by the relevant PRC authorities since we first started using “科兴” in the trade name of Sinovac Beijing in 2001.authorities. If the “科兴” trademark owned by Shenzhen Kexing is ever officially identified as a “Well-Known trademark,”Trademark” in the future, however, we may be subject to trademark infringement claim for the use of “科兴” in our trade name.
Although the trademark application and the trade name approval systems are administered separately in China, that we may lose our ability to use the “科兴” trademark in our trade name due to a successful trademark infringement claim, which may adversely affect our ability to maintain and protect our brands, cause us to incur litigation costs and divert resources and management attention. As our brand name is becoming more recognized in the vaccine market, we are working to maintain, increase and enforce our rights in our trademark portfolio, the protection of which is important to our reputation and branding.
names.
We have registered our own domain names, includingwww.sinovac.com.cn andwww.sinovac.com, with the China Internet Network Information Center.
Insurance
We maintain property insurance coverage with an annual aggregate insured amount of approximately RMB697.6RMB1,062 million ($107.2162.8 million) in 2020 to cover our property and facilities from claims arising from fire, earthquake, flood and a wide range of other natural disasters. OurWe are carrying worldwide product liability insurance offor Healive, Bilive, Anflu, Panflu and Inlive worldwide(excluding the United States and Europe) from April 20172020 to April 2018 is limited. In addition, we2021. We do not carry liability insurance to cover liability claims that may arise from the incidents relating to the clinical trials of our vaccine products. Our insurance coverage may not be sufficient to cover any claim for product liability or damage to our fixed assets.
We do not maintain any business interruption insurance. We are carrying worldwide product liability insurance for Healive, Bilive, Anflu, Panflu and Inlive (excluding U.S. and Europe) from April 2017 to April 2018. We are negotiating with the insurance providers for a renewal of our product liabilities insurance policies. See “Item 3. Key Information — D. Risk Factors — Risks Related to Our Company — We could be subject to costly and time-consuming product liability actions and, because our insurance coverage is limited, our exposure to such claims could cause significant financial burden.”
Regulatory Framework of the Pharmaceutical Industry in the PRC
The testing, approval, manufacturing, labeling, advertising and marketing, delivery, post-approval safety reporting, and export of our vaccine products or product candidates are extensively regulated by governmental authorities in the PRC and other countries.
In the PRC, the CFDANMPA regulates and supervises biopharmaceuticalvaccine products under the Pharmaceutical Administration Law, the Implementing Regulations on Pharmaceutical Administration Law, the Vaccine Administration Law, the Administration of Registration of Pharmaceuticals Procedures, and other relevant rules and regulations which are applicable to manufacturers in general. Every step of our biopharmaceuticalvaccine production is subject to the requirements on the manufacture and sale of pharmaceutical products as provided by these laws and regulations, including but not limited to, the standards of clinical trial, declaration, approval and transfer of new medicine registrations, applicable industry standards of manufacturing, distribution, packaging, advertising and pricing.
Pre-clinical Studies. Pre-clinical studies include in-vitro laboratory evaluation of the product candidate, as well as in-vivo animal studies to assess the potential safety and efficacy of the product candidate. Pre-clinicalNon-clinical studies must be conducted in compliance with Good Laboratory Practice for Non-clinical Studies of Pharmaceuticals. With respect to vaccines, the pre-clinical studies should also comply with Technical Guidance for Pre-clinical Studies on Preventive Vaccines. We must submit a file package for investigational new drug application or IND,(“IND”) to the Centers for Drug Evaluation. The files should include pharmaceutical research, pharmacology and toxicology research, togetherapplicant shall be provided with the records of manufacturing and testing and the sample of product candidate. We cannot commencea decision on whether a consent is granted to conduct clinical trials until we obtain the approval of IND.study. If no decision is provided within 60 days, it’s regarded as permission granted. We cannot assure that submission of an IND will result in the Centers for Drug Evaluation allowing clinical trials to begin, after these trials commence, issues could arise that result in the suspension or termination of such clinical trials.
Clinical trials. Clinical trials involve the administration of the product candidate to healthy volunteers or vaccineespatients under the supervision of principal investigators, who are generally physicians or an independent third party not employed by us or under our control. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. In Phasephase I, the initial introduction of the drug into human subjects, the drug is usually tested for safety (adverse effects), dosage tolerance, and pharmacologic action. Phasephase II usually involves studies in a limited vaccineepatient population to evaluate preliminarily the efficacy of the drug for specific, targeted conditions and to determine dosage tolerance and appropriate dosage and to identify possible adverse effects and safety risks. Phase III trials generally further evaluate clinical efficacy and test further for safety within an expanded vaccineepatient population. Clinical trials have to be conducted in compliance with the Good Clinical Trial Practice of Pharmaceuticals.
With respect to vaccines, we also have to comply with the CFDA’sNMPA’s Requirements on Application for Clinical Trial of New Preventive Biological Products. The sample vaccine products must be tested by the NIFDC before they may be used in the clinical trials. We or the CFDANMPA may suspend clinical trials at any time on various grounds, including a finding that subjects are being exposed to an unacceptable health risk.
After three phases of clinical trials, we apply for New Drug Application or NDA.(“NDA”). We submitto the Centers for Drug Evaluationthe NDA file package, which includes a clinical trial research report, pharmaceutical research data, and records of manufacturing and testing of three batches of products, to apply for a new drug certificate and/ or production license.the marketing authorization. For vaccines, we have to comply with the CFDA’sNMPA’s Guidelines for Clinical Trial Report on Vaccines.
Communication Meeting. In order to improve review process of regulatory approval, NMPA has set up a communication channel between the applicant and reviewing agencies. Applicant can discuss material safety issues during the human clinical study or significant technical issues arise during the development process with regulatory agencies. This kind of meetings can also be held at critical stages in the entire process of drug development, including before IND application, before phase III human clinical studies, or before NDA.
New Drug CertificateMarketing Authorization.The Centersapplicant can submit an application for a marketing authorization with submission of relevant research materials after completing the research on pharmacology, pharmacological toxicology and clinical trials to support the registration of drugs on the market, establishing quality standards, completing the verification of commercial-scale production processes, and preparing to accept the verification and inspection of drug registration. If the application dossiers pass the formal examination, they will be accepted. The Center for Drug Evaluation will conduct a preliminary examinationwould organize pharmaceutical, medical and other technicians to evaluate the accepted application of our application for a new drug certificate. Once it decidesmarketing authorization according to accept our application based upon such preliminary examination, the Centersrequirements. The Center for Drug Evaluation will begin technical review,would then initiate the verification and give their technical opinion to CFDA. At the meantime, according to the requirement of technical review, the Centers for Drug Evaluation can ask for an on-site examinationinspection action based on the circumstancesrisks identified during the evaluation and the relevant technical institutes would conduct the verification and inspection within the time limit. NMPA will verify the
authenticity of our clinical trialssubmitted document, reliability of submitted data and pharmaceutical research.conduct site inspection on research lab and production site, as well as other inspections as NMPA thinks necessary. For vaccine products, the on-site inspection on production site and the inspection of the quality management on the production of vaccine products shall be conducted. Vaccine products shall be tested before marketing authorizations are issued. The CFDA will decide whether or not to issue a new drug certificate to us. We consider obtainingtesting includes confirmation on the new drug certificate for our product candidates a significant milestone in our business.
Production Permit. Simultaneously with the application of new drug certificate, we also apply to CFDA for a production license to manufacture the new drug to be approved by the CFDA. The production license application will be examined with similar stage procedure as for the new drug certificate, first byquality stand and sample testing. Subsequently the Center for Drug Evaluation shall conduct a comprehensive review of the safety, effectiveness and quality controllability of drugs on the CFDAbasis of the last. Afterdrug registration declaration information, verification results and inspection results, etc., and, if the Center for Drug Evaluation acceptsconclusions of the application,comprehensive review are adopted, the Center for Drug Evaluationdrug marketing authorization will review the application filesbe approved and give technical opinion. If the Center for Drug Evaluation is satisfied with our application materials, ita drug registration certificate will notify us to apply for the on-site production inspection within six months after being so notified.
be sent.
The Center for Food and Drug Inspection will conduct an on-site inspection on our production procedures within 30 days after receipt of our application and take samples from three batches of our products, and the NIFDC will test the selected samples and later submit its testing reports to the Centers for Drug Evaluation. The Center for Food and Drug Inspection must submit the on-site production inspection report to Center for Drug Evaluation. The Centers for Drug Evaluation will form a comprehensive opinion based upon the technical review and evaluation opinion, the on-site production inspection report and the testing results of the samples, and submit its opinion and relevant materials to the CFDA. The CFDA will decide whether or not to issue the production permit to us. If the product approval and production approval both meet the criteria, the CFDA will issue the production permit together with the new drug certificate at the same time. The production permitmarketing authorization is valid for a term of five years and must be renewed before its expiration. During the renewal process, our production facilities will be re-evaluated by the appropriate governmental authorities and must comply with effective standards and regulations.
Under certainDuring or after a public health emergency, the NMPA may decide, in accordance with the law, to apply special approval for the prevention and treatment of medicines necessary for emergency response to public health emergencies. For applications for the registration of drugs subject to special approval, the NMPA shall, organize and carry out the processing, review, verification and inspection of drug registration in a simultaneous manner, following the principles of centralized coordination, early intervention, and rapid, efficient and scientific examination and approval. The circumstances, for instance, where drugs are developed to cure a disease without effective therapeutic methods,procedures, time limits and requirements of special approval shall be implemented in accordance with the CFDA provides a special proceeding for its reviewprovisions of the new drug certificate application and production permit application relating to such drugs.
The CFDA will specify a monitoring period ranging from three to five years when approving the first production permitspecial approval procedure for most new drugs. During this monitoring period, the manufacturers holding the new drug certificates must regularly report, among other things, the production process, efficacy, stability and side effects of the new drugs involved to the provincial level CFDA. During the same period, the CFDA will not accept any new application for approval of the same drug involved. However, if a third party has filed an application for the same drug and obtained the clinical trial permit before the monitoring period commences, the third party may still obtain a new drug certificate and production permit for the same drug.
medicines.
We may also be required to conduct clinical trials prior to commencing the manufacturing of pharmaceutical products for which there are published state pharmaceutical standards.
GMP Certificate. After receiving the production permit, we should submit the GMP inspection application to the provincial level CFDA, the provincial level CFDA will arrange for the inspection on our facilities for purposes of GMP inspection. If we pass the GMP inspection, the provincial level CFDA will issue the GMP Certificate. A GMP Certificate is used to approve the quality system, including quality assurance and quality control management, production management, materials and products, qualification and validation, facility and equipment. The CFDA has issued GMP standards for pharmaceutical manufacturers to minimize the risks arising out of the production process of drugs that are not identified or eliminated through testing the final products.
A GMP Certificate is valid for five years and we should apply for a renewal of our GMP Certificate no later than six months prior to the expiration of our GMP Certificate.
We cannot commence the manufacture of a new drug unless and until we have obtained a valid new drug certificate, production permit and GMP Certificate.
Batch Approval. Our vaccine products cannot be distributed in the market before receiving batch approval. After we obtain the GMP certificate,production permit, we will start commercial production, after which we need to apply for batch release approval by the NIFDC for the commercial lots. For each batch of products, we will provide samples taken from cold rooms by inspectors, together with manufacturing records, self-testing records and other quality control documents. The NIFDC will review the documents and test the samples and issue a batch approval within approximately two months if our manufacture procedures and the quality of our products meet CFDAthe NMPA standards. With the batch approval, we may distribute the approved batch of vaccines to the market.
Regulatory Framework of the Vaccine Administration in the PRC
On December 1, 2019, the PRC Vaccine Administration Law, China’s first legislation dedicated to vaccine management, became effective.
The new law is expected to enable the regulators to close loopholes and rein in risks in vaccine management. In addition, the strategic position of the vaccine industry to the whole country and its welfare nature concerning the general public have been clearly recognized in the new law. The Chinese government will support the fundamental scientific research and commercialization research of vaccine products to encourage the development of innovation technologies and new vaccine products. The research and development, production and stockpiling of vaccine products preventing serious diseases will be part of the state strategy. The new law also makes it very clear that the PRC government will encourage the further consolidation of the vaccine industry so that manufacturers with large scale production capacities of more quality products, using more advanced technologies, could emerge. All of these new regulatory regimes to be established under the new law may largely boost the confidence of the public in vaccine products manufactured in China.
The new PRC Vaccine Administration Law implements more stringent supervision of the entire process of vaccine development, production, delivery, and inoculation. The legislation mandates both government oversight and the duty of manufacturers to report compliance in all substantial aspects of the whole lifecycle of vaccine products. The sanctions and penalties for the illegal activities have been significantly increased. For instance, the sanctions for production or selling of fake or substandard vaccines extend to include confiscating of all illegal gains obtained from and the materials, equipment and other facilities and resources used for production or selling of fake or substandard vaccines, suspension of business for corrections, revoking of drug registration certificate or production license. The fines can be as high as 15 times to 50 times of the market value of the fake vaccines or 10 times to 30 times of the market value of the substandard vaccines. In the case of serious circumstances, the legal representative, the person in charge or the key personnel who are directly responsible for production or selling of fake or substandard vaccines and the other persons responsible are also subject to sanctions of confiscating their income during the production period of the fake or substandard vaccines, a fine of one time to ten times of the said income. Such persons will be permanently banned from engaging in drug production activities and will be subject to 15 days of confinement in prison.
Classification of Vaccines
Vaccines refer to preventive biological products for human vaccination so as to prevent and control the occurrence and prevalence of diseases, including vaccines under immunization programs (the “Vaccines Under Program”) and vaccines not covered by immunization programs (the “Vaccines Beyond Program”).
• | Vaccines Under Program refer to the vaccines that must be inoculated to residents in accordance with government provisions, including vaccines determined in national immunization programs, vaccines added by provincial government in the implementation of national immunization programs, and vaccines used in emergency vaccination or group preventive vaccination organized by governments at the |
county level or above or their competent health departments, which is similar to the Vaccines of Class 1 under the previous classification under the Administrative Regulations on the Circulation of Vaccines and Vaccination of the PRC. |
• | Vaccines Beyond Program refer to other vaccines voluntarily inoculated by residents, which is similar to Vaccines of Class 2 under the previous classification. |
Mandated Manufacturing
Market authorization holder of vaccines refers to the enterprise who obtains both a vaccine registration certificate and a drug manufacturing license. Market authorization holders of vaccines must have adequate vaccines manufacturing capacity. Where the mandated manufacturing is necessary due to inadequate vaccines manufacturing capacity, the market authorization holder of vaccines must obtain an approval of the medical products administration under the State Council for such mandated manufacturing.
Keeping of Sales Records
Market authorization holders of vaccines must keep accurate and complete sales records and keep the same for reference for at least five years after the shelf life of the relevant vaccines.
Electronic Traceability of Vaccines
The PRC government will set up national vaccines electronic traceability collaboration platform and the market authorization holders of vaccines must also establish vaccines electronic traceability system to be linked with the national vaccines electronic traceability collaboration platform, for the purpose of integrating the traceability information on the whole process of vaccine production, circulation and vaccination so as to realize the traceability of vaccines. In case of failure of complying with such obligation, the market authorization holder of vaccines will be imposed a fine up to RMB2 million.
Compulsory Vaccines Liability Insurance
The PRC government will implement the rules for compulsory vaccines liability insurance. The market authorization holders of vaccines must underwrite the compulsory vaccine liability insurance. Specific implementing measures for the compulsory vaccine liability insurance system will be formulated by the medical products administration under the State Council in collaboration with the health administration and insurance regulatory authority under the State Council. In case of failure of complying with such obligation, the market authorization holder of vaccines will be imposed a fine up to RMB2 million.
Post-Market Management of Vaccines
(a) Post-market investigation
The market authorization holders of vaccines must establish the whole-lifecycle quality management system of vaccines, and carry out post-market investigation to further confirm the safety, efficacy and quality controllability of the vaccines put into the market. In case of failure of complying with such obligation, the market authorization holder of vaccines will be imposed a fine up to RMB2 million.
(b) Quality retrospection analysis and risk reporting
The market authorization holders of vaccines must set up a vaccines quality retrospection analysis and risk reporting system, and faithfully report relevant information on vaccine manufacturing, distribution, post-market investigation and risk management to the medical products administration under the State Council on a yearly basis. In case of failure of complying with such obligation, the market authorization holder of vaccines will be imposed a fine up to RMB2 million.
(c) Post-market evaluation
The medical products administration under the State Council has the right to request a market authorization holder of vaccines to conduct post-market evaluation or directly organize post-market evaluation. The medical products administration under the State Council will cancel
the drug registration certificate for vaccines with serious adverse event to vaccination or endangering human health due to other causes.
Information Disclosure
The market authorization holders of vaccines must establish an information disclosure system and promptly disclose vaccine product information, package insert and labels, situations concerning the implementation of quality control, lot release, recall, inspection and punishment imposed and compulsory vaccine liability insurance effected, etc. on its website as required. In case of failure of complying with such obligation the market authorization holder of vaccines will be imposed a fine up to RMB2 million.
Following the promulgation of the PRC Vaccine Administration Law in June 2019, the Ministry of Industry and Information Technology of the People’s Republic of China (“MIIT”) announced that the thresholds to entry in the Chinese vaccine industry will be raised and they will more strictly control the number of new vaccine manufacturers to be established. MIIT will encourage the centralization and consolidation of the vaccine industry.
C. | Organizational Structure |
The following diagram illustrates our company’s organizational structure, and the place of incorporation, ownership interest and affiliation of each of our subsidiaries as of the date of this report.
As of December 31, 2020, we held 100% equity interest in Sinovac Biotech (Hong Kong) Limited, our subsidiary incorporated in Hong Kong, Sinovac Biotech (Singapore) Pte. Ltd., our subsidiary established in the Singapore and Sinovac Biomed Co., Ltd., our subsidiary established in the PRC; and we held 73.09% of equity interests in Sinovac Biotech Co., Ltd., our subsidiary established in the PRC, 59.24% of the equity interests in Sinovac Life Sciences Co., Ltd. (formerly known as Sinovac Research & Development Co., Ltd.), our subsidiary established in the PRC and 68% of the equity interests in Sinovac (Dalian) Vaccine Technology Co., Ltd., our subsidiary established in the PRC.
* | Dalian Jin Gang Group Co., Ltd. owns the remaining |
** | Sinobioway Bio-medicine Co., Ltd., formerly named Xiamen Bioway Group Co., Ltd, owns the remaining 26.91% equity interest in Sinovac |
*** | Affiliates of Sino Biopharmaceutical Limited, Keding Investment (Hong Kong) Limited, Vivo Capital Fund IX and Prime Success, L.P. owns 15.38%, 12.69%, 6.345% and 6.345%, respectively, of the remaining equity interest in Sinovac LS, former name |
****The former name is Sinovac Zhong Yi Bio-pharmaceutical Co., Ltd.
D. |
Property, Plants and Equipment |
We are headquartered in the Peking University Biological Industry Park (Haidian)in Haidian District in Beijing in a 48,900-square-foot facility, of which approximately 16,700 square feet are used as office space and approximately 32,200 square feet are used for the production plant for Healive and Bilive, where the production equipment for hepatitis vaccines is located. We ownBilive. Sinovac Beijing owns the above-described 48,900-square-foot facility in Beijing.
Peking University Biological Industry Park.
In August 2004, we signed two 20-year leases with SinoBioway Biotech Group Co. Ltd. (“SinoBioway”), or SinoBioway, pursuant to which we leased two buildings of approximately 28,000 and 13,300 square feet, respectively, located at the Peking University Biological Park in Beijing. We house our Anflu manufacturing and R&D center in these two buildings. One of the lease agreements was amended on August 12, 2010 to reflect an increase in the lease payment.rental. In June 2007, we signed another 20-year lease with SinoBioway, in order to expand Sinovac Beijing’s production facilities in Beijing,our Shangdi site, pursuant to which we leasedlease one building of approximately 37,000 square feet, located at Peking University Biological Park. Part of our administrative offices and filling facilities are located in this building until 2013. The filling facilities werehave been moved to Changping site insince 2013, where we are settingand the original filling facilities space is set up as the commercial production facility for our pneumococcal vaccines.
In September 2010, we entered into an agreement with SinoBioway, under which we lease a space of 6,778 square feet. The lease term is five years and we useduse it for our research and development function. On April 8, 2013, we entered into three supplemental agreements with SinoBioway, under which the expiration date of each of the four operating lease agreements was extended to April 7, 2033.
All these offices and production facilities in the Peking University Biological Industry Park are known as our Shangdi site. We have three production lines located inat the Peking University Biological Park (Haidian). OurShangdi site. The production line to manufacture our hepatitis vaccines, Healive and Bilive, interchangeably has an aggregate combined production capacity of approximately 10 million doses annually. OurThe production line to manufacture our flu vaccines, Anflu, Panflu and Panflu.1, interchangeably has an annual production capacity of approximately eight15 million doses of Anflu (northern hemisphere), or the equivalent of 20 million doses of Panflu or 20 million doses of Panflu.1.
. We have also built a PPV production line at the HaidianShangdi site with designed annual capacity of five5 million doses per year. In May 2013, our filling and packaging line in Changping site was granted the GMP certificate for the first time, after which we moved the filling and packaging activities to our Changping site. In July 2016, we started to build our sIPV plant for bulk production on our Changping site. The expected capacity is approximately 20 million doses. The five-year GMP renewal on Changping site was successfully completed in April 13, 2018.
In February 2010, we acquired a right to use approximately 312,400 square feet of land located in Changping District, Beijing, or Changping Site, with five buildings with a total built-out area of 32,322 square meters (approximately 347,900 square feet) on 29,021 square meters (for a total consideration of approximately RMB123.6 million ($19.1 million)). We have made all required payments by December 31, 2012. We have built a new filling and packaging line, EV71 production facilities and a warehouse on the Changping site. The new filling and packaging line and warehouse commenced operation in May 2013 and December 2010, respectively. The EV71 vaccine production line has a designed annual capacity of 20 million doses and was granted the new GMP certificate in January 2016. As described above, a representative of Sinobioway Medicine and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices and cut power to ourat the Shangdi site. Due to the actions of the representative of Sinobioway Medicine, Sinovac Beijing was forced to destroy the affected products and temporarily
decided to stop the production at the impacted facility in order to maintain product safety. The production resumed at the Shangdi site in the second half of 2018.
In February 2010, we acquired a right to use approximately 312,400 square feet of land located in Changping District, Beijing (“Changping Site”) with five buildings with a total built-out area of 32,322 square meters (approximately 347,900 square feet) for a total consideration of approximately RMB123.6 million ($17.8 million). We have made all required payments by December 31, 2012. We built a new filling and packaging line, EV71 production facilities and a warehouse at the Changping site. In May 2013, the new filling and packaging line at the Changping site was granted the GMP certificate, following which, we moved all the filling and packaging activities to the Changping site. The five-year GMP renewal at the Changping site for the filling and package line was successfully completed on April 13, 2018. The new warehouse was put into operation in December 2010. The EV71 vaccine production line at the Changping site has a designed annual capacity of 20 million doses and was granted the new GMP certificate in January 2016. In July 2016, we started to build our sIPV plant for bulk production at the Changping site. The expected capacity is approximately 20 million doses.
In November 2009, we entered into an agreement with Dalian Jin Gang Group to establish Sinovac Dalian. In January 2010, we established Sinovac Dalian which focuses on the research, development, manufacturing and commercialization of live-attenuated vaccines, such as varicella, mumps and rubella vaccines for human use. Sinovac Dalian has seven existing buildings with a total built-out area of 20,000 square meters (approximately 215,280 square feet) on a parcel of land of 95,685 square meters (approximately 1,030,000 square feet) of land,, located at DD Port, Economic and Technical Development Zone, Dalian City, Liaoning province. The construction of a varicella vaccine production plant within the existing building in Sinovac Dalian with total area of 4,458 square meters is underway. The expected annual capacity is five million doses. Sinovac Dalian received its GMP certificate (2010 version) from the CFDANMPA for its mumps vaccine in September 2012.2012 for five years. The renewed GMP certificate issued by Food and Drug Administration of Liaoning Province was obtained on February 13, 2018, which will remain valid until February 12, 2023. The construction of a varicella vaccine production plant was completed in 2019. The production permit was granted in December 2019 after NMPA’s inspection of our varicella vaccine production line. The annual capacity of the varicella production line is 5 million doses.
In 2009, we established Sinovac LS focusing on R&D. In 2020, Sinovac LS obtained a drug production license. Currently, Sinovac LS is mainly committed to the research and development, production and sales of COVID-19 vaccine, CoronaVac. Sinovac LS Ltd is located in the biomedical industry base in Daxing District, Beijing, which has three existing production bases, Tianfu factory, Yongda factory and Xiangrui factory. Sinovac LS had a rapid growth in 2020. As of the date of this annual report, Sinovac LS has a total of 15 existing and under construction buildings, with a total built-out area of 144,500 square meters and a total construction area of 196,000 square meters. Sinovac LS was granted national and WHO GMP certifications in 2020. When construction is completed and facilities are put to use, the annual production capacity of CoronaVac by Sinovac LS is expected to reach 2 billion doses.
Not applicable.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this annual report on Form 20-F. This discussion may contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Item 3. Key Information — D. Risk Factors” or in other parts of this annual report on Form 20-F.
A. | Operating Results |
Overview
We are a fully integrated, China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines against infectious diseases. We have successfully developed a portfolio of products, consisting of vaccines against
hepatitis A, hepatitis B, enterovirus type 71,EV71, influenza viruses, mumps, varicella, pneumococcal and mumps.COVID-19. The following table sets forth certain information on our commercialized products.
| Number of Doses Sold | ||||||||
| Products | Date of Approval | 2017 | 2016 | 2015 | ||||
| Healive | May 2002 | 3.8 million | 3.5 million | 4.1 million | ||||
| Bilive | June 2005 | 0.6 million | 0.4 million | 2.3 million | ||||
| Anflu | October 2005 | 2.7 million | 2.0 million | 3.2 million | ||||
| Inlive | January 2016 | 4.7 million | 1.5 million | nil | ||||
| Panflu(1) | April 2008 | nil | 1.9 million | 1.1 million | ||||
| Panflu.1(1) | September 2009 | nil | nil | nil | ||||
| Mumps | September 2012 | 0.3 million | 0.3 million | 1.2 million | ||||
Products | Date of Approval | |
Healive | May 2002 | |
Bilive | June 2005 | |
Anflu | October 2005 | |
Inlive | January 2016 | |
Panflu(1) | April 2008 | |
Panflu.1(1) | September 2009 | |
Mumps | September 2012 | |
Varicella | December 2019 | |
Quadrivalent influenza | June 2020 | |
Pneumococcal polysaccharide | December 2020 | |
CoronaVac(2) | February 2021 |
(1)We sold all of our Panflu and Panflu.1 products to the PRC government. Our sales of Panflu and Panflu.1 depend on the completion of government audit on our fulfillment to the stockpiling order.
(2) CoronaVac was granted conditional marketing authorization in China on February 5, 2021.
Our pipeline consists of various vaccine candidates in the pre-clinical and clinical trial development phases and production application phase in China. We obtained the approvals to conduct clinical trials of PPV, pneumococcal conjugate vaccine, sIPV varicella vaccine and quadrivalent flu vaccineQIV in May 2014, January 2015 and November 2015, October 2015 and November 2016, respectively.
And the new drug applications for PPV, sIPV and QIV are received by NMPA in June 2017, January 2019 and March 2019. NMPA approved and issued a product license for our varicella vaccine, QIV vaccine and PPV vaccine in December 2019, June 2020 and December 2020, respectively. We initiated the development of an inactivated vaccine (named CoronaVac) against COVID-19 on January 28, 2019 and began rolling submission to the MMPA since September 2020 and the NMPA carried out rolling reviews when the submission was made. On February 5, 2021, NMPA granted a conditional marketing authorization to us for CoronaVac in individuals aged 18 and above.
Our Proprietary Rights
Healive was co-developed by Tangshan Yian and the NIFDC. In April 2001, Tangshan Yian contributed its proprietary rights to Healive to Sinovac Beijing as its capital contribution to Sinovac Beijing.contribution. In 2002, the NIFDC, Tangshan Yian and Sinovac Beijing agreed that Sinovac Beijing owned the right to market and sell Healive, and that Sinovac Beijing was required to pay the NIFDC approximately $1 million for the Healive technology consulting fee that Tangshan had not paid by that time. We obtained Healive’s new drug certificate from the CFDANMPA in December 1999, the production license in May 2002, and final PRC regulatory approval for production of Healive in May 2002. Production of Healive commenced in July 2002.
Bilive was initially developed by Tangshan Yian. In March 2002, Tangshan Yian and Beijing Keding entered into an agreement under which Tangshan Yian transferred to Beijing Keding its proprietary rights to Bilive at no cost. In August 2002, Sinovac Beijing acquired the proprietary rights to Bilive from Beijing Keding in consideration of a 10.7% equity interest in Sinovac Beijing and a cash payment of $18,000. Beijing Keding is owned by Mr. Weidong Yin and three other senior officers of Sinovac Beijing. We received the production license for Bilive from the CFDANMPA in January 2005. In June 2005, we obtained the final PRC regulatory approval for production of Bilive. The cost of the proprietary rights to Bilive was expensed as purchased in-process research and development. Production of Bilive commenced in June 2005.
In March 2003, Sinovac Beijing acquired the proprietary rights to Anflu from Tangshan Yian at the vendor’s cost. In November 2004, we completed the acquisition of 100% of the shares of Tangshan Yian. We received final PRC regulatory approval for the production of Anflu in October 2005. The cost of the proprietary rights to Anflu was expensed as purchased in-process research and development.
Sinovac Beijing started to research and develop the H5N1 vaccine in 2004. In 2004, Sinovac Beijing entered into an agreement with the National Institute for Biological Standards and Controls or NIBSC,(“NIBSC”), an England based laboratory under the WHO, on transferring the H5N1 virus strain. According to the agreement, Sinovac Beijing as the recipient would receive the materials and information from NIBSC. The agreement indicated that Sinovac Beijing can only use received materials and information for academic in-house research purposes and Sinovac Beijing shall negotiate with the owner of reverse genetics technology pertaining to virus strain for any commercial purpose. In April 2008, Sinovac Beijing received a production license for H5N1 from the PRC government and started to produce H5N1 vaccines for the government-stockpiling program in June 2008.
In 2011, we licensed from MedImmune certain rights to use patented reverse genetics technology pertaining to virus strain production for H5N1 influenza vaccine. We have agreed to pay an upfront license fee, milestone payments up to an aggregate of $9.9 million based upon the achievement of cumulative net sales of licensed products in China (including Hong Kong and Macau), as well as royalty payments in single digit
of net sales of the licensed products in China (including Hong Kong and Macau). On August 15, 2012, we entered into amended agreements with MedImmune to, among other things, extend the effectiveness of each agreement to reflect revised termination dates between December 2015 and May 2021. License fee and royalties of $3.4 million accrued at the end of 2011 was paid in 2012. We accrued a royalty of $9,000 at the end of 2018, which was paid in 2019. No paymentsroyalties were madeincurred for the years ended December 31, 2020 and 2019.
No amortization expenses were recorded in 20132020, 2019 and 2015. We made a $0.9 million royalty payment to MedImmune in 2014.
Amortization expense2018 for these proprietary rights was nil, nil and $0.4 million in 2017, 2016 and 2015, respectively.
as they were fully amortized.
Research and Development Programs
The research and development strategy is developed by management and reviewed and approved by the board of directors of our company. Utilizing the resources and platform of each subsidiary, the R&D team of each subsidiary selects a R&D project and develops a feasibility analysis for review and approval.approval by the board of directors. Once the project is approved, we will track the R&D progress as well as the spending of each project.project will be tracked. Each year all the ongoing R&D projects will be reviewed along with the budgeting for the following year.
We also use our research and development resources, including employees and our technology, across multiple product development programs. The table below presents our best estimate of our total research and development costs allocable to our leading research and development programs for the periods indicated. We have allocated direct and indirect costs to each program based on certain assumptions and our review of the status of each program, payroll related expenses and other overhead costs based on estimated usage by each program.
| Year ended December 31, | ||||||||||||
| 2017 | 2016 | 2015 | ||||||||||
| Research and development programs | ||||||||||||
| EV71 vaccine | $ | 306 | $ | 7 | $ | 325 | ||||||
| PPV | 3,079 | 3,181 | 2,816 | |||||||||
| Varicella vaccine | 4,219 | 2,683 | 1,650 | |||||||||
| sIPV | 9,061 | 3,133 | 1,617 | |||||||||
| Pneumococcal Conjugate Vaccine | 627 | 461 | 1,155 | |||||||||
| Mumps vaccine | 141 | 251 | 235 | |||||||||
| Others | 3,056 | 2,932 | 1,692 | |||||||||
| Total | $ | 20,489 | $ | 12,648 | $ | 9,490 | ||||||
The process of developing, obtaining and maintaining regulatory approvals for new products is lengthy, expensive and uncertain. While the development may take years to complete, the market environment may change from the time when the project is selected, which will have an impact to the expected return of the investment. We anticipate that we will frequently monitor the progress of each key project and determine which of our early stage product candidates is best suited for further development, as well as how much funding to direct to each program, on an on-going basis in response to the scientific and clinical success and commercial potential of each product candidate.
We have obtained the new drug certification, production license and GMP certification for our new core product, the EV71 vaccine. We started the commercial production and sales activities of EV71 vaccine in 2016. We have completed phase III clinical trials for the pneumococcal polysaccharides vaccine andPPV, filed an application of productionGMP inspection in February 2020 and received the product license for our PPV vaccine from NMPA in 2017.December 2020. We also completed Phasephase III clinical trials of sIPV in 2018 and file the new drug application in September. We have completed phase III clinical trial on our varicellaQIV in 2017.2019, filed the new drug application in March 2020 and received the product license for our QIV vaccine from NMPA in June 2020. We also completed Phase IIcommenced phase I clinical trial on our COVID-19 vaccine in April 2020, commenced phase III clinical trials of Sabin-IPV vaccine in 2017. In addition, have obtained clinical trial licenseJuly in Brazil, Turkey, Indonesia and Chile, filed for the pneumococcal conjugate vaccine.
conditional marketing authorization in February 2021 and received a conditional marketing authorization for CoronaVac from NMPA on February 5, 2021.
Government Grants
Deferred government grants represent funding received from the government for research and development, or investment in building or improving production facilities. The amount of deferred government grants as of year-end is net of research and development expenditures or depreciation incurred or those recognized as government grants income. We received government grantgrants that were deferred in the amount of RMB15.6RMB92.4 million ($2.314.2 million), RMB5.0RMB6.7 million ($0.71.0 million) and RMB1.5RMB23.4 million ($0.23.5 million) in 2017, 20162020, 2019 and 2015,2018, respectively. In addition, we received RMB2.0RMB21.7 million ($3.1 million), RMB3.5 million ($0.5 million) and RMB1.7 million ($0.3 million) in other government grants and subsidies that were recognized in the statements of comprehensive income (loss) in 2017.
2020, 2019 and 2018, respectively.
Deferred government grants included RMB3.7the following:
Government grants for property, plant and equipment
We have four deferred government grants related to property, plant and equipment. We have fulfilled the conditions attached to one grant and expect to fulfill another one in 2021. RMB3.4 million ($0.6 million), being the unamortized portion of a grant that we received in 2007 for construction of a pandemic influenza vaccine plant and buildings (RMB5.5 million ($0.8 million) as of December 31, 2016). RMB1.8 million ($0.3 million), which will be amortized in 2018,2021 which was included in the current portion of deferred government grantsgrant and RMB1.9RMB11.2 million ($0.31.7 million), which will be amortized after 2018,2021 which was included in the non-current portion of deferred government grants. The production facility grant requires us to have the entire facility available to manufacture pandemic influenza vaccines at any given moment upon request by the PRC government. We have fulfilled the conditions attached to the government grant. Government grants relating to these production facilities of $0.3 million, $0.3 million and $0.3 million for the years ended December 31, 2017, 2016 and 2015, respectively, were recorded as a reduction to depreciation expense for those respective years.
Deferred government grants also included RMB1.3 million ($0.2 million) being the unamortized portion of a grant that we received in 2009 for purchasing equipment for H1N1 vaccine production (RMB2.1 million ($0.3 million) as of December 31, 2016). RMB0.9 million ($0.1 million) which will be recognized in 2018 was included in the current portion of deferred government grants and RMB0.4 million ($57,000) which will be recognized after 2018 was included in the non-current portion of deferred government grants. We have fulfilled the conditions attached to the government grant. Government grant relating to this production facility of $0.1 million, $0.1 million and $0.1 million for the years ended December 31, 2017, 2016 and 2015, respectively, were recorded as a reduction to the related depreciation expense.
Deferred government grants also included RMB0.2 million ($30,000), being the unamortized portion of a grant that we received in 2013 for purchasing equipment for H5N1 vaccine production. We have fulfilled the conditions attached to the government grant. RMB0.1 million ($15,000) to be amortized in 2018 was included in the current portion of deferred government grants and RMB0.1 million ($15,000) which will be amortized after 2017 was included in the non-current portion of deferred government grants. Government grant relating to this production facility of $15,000, $15,000 and $16,000 for the year ended December 31, 2017, 2016 and 2015, respectively, were recorded as a reduction to the related depreciation expense.
Deferred government grants also included RMB14.5 million ($2.2 million) being the unamortized portion of a grant the Company received in 2015 for equipment purchase and construction of the EV71 vaccine production facility (RMB17.8 million ($2.6 million) as of December 31, 2016). We have fulfilled the conditions attached to the government grant in 2016. RMB3.3 million ($0.5 million) which will be amortized in 2018 was included in the current portion of deferred government grants and RMB11.3 million ($1.7 million) which will be recognized after 2018 was included in the non-current portion of deferred government grants. RMB2.7RMB2.8 million ($0.4 million) of government grant relating to these production facilities was recorded as a reduction to depreciation expense for the year ended December 31, 2017,2020, as compared to $0.4 million and RMB0.3$0.4 million for the years ended December 31, 2019 and 2018, respectively, and RMB0.5 million ($80,000) was recorded as government grant recognized in income for the year ended December 31, 2017.
Deferred government grants also included RMB5.12020, as compared to $79,000 and $82,000 for the years ended December 31, 2019 and 2018. RMB8.4 million ($0.81.3 million) beingrepresents the unamortized portion of aone grant the Companywhere we received in 2017 for EV71 phase IV clinical research. As of December 31, 2017, the Companybut has not fulfilled the conditions attached to the government grant.grants. As the Company doeswe do not expect to fulfill the conditions within one year, the grant is recorded as a non-current deferred government grant.
Government grants for research and development
DeferredWe have ten deferred government grants also included RMB10.0 million ($1.5 million) being the unamortized portion of a grant the Company received in 2017 for purchasing equipment for sIPV vaccine production. As of December 31, 2017, the Company has not fulfilledrelated to various research and development projects. We expect to fulfil the conditions attached to the government grant. As the Company does not expect to fulfill the conditions within one year, the grant isnine grants in 2021 and recorded as a non-current deferred government grant.
As of December 31, 2017, conditions attached to a government grant received in 2017 in the amount of RMB0.5RMB95.2 million ($78,000) for certain production facilities were fulfilled, of which RMB0.1 million ($19,000) will be amortized in 2018 and RMB0.4 million ($55,000) will be amortized after 2018, and RMB 30,000 ($4,000) of government grant relating to these production facilities was recorded14.6 million) as a reduction to depreciation expense for the year ended December 31, 2017. As of December 31, 2017, conditions of four government grants totaling RMB7.1 million ($1.1 million) have not been fulfilled by us. We expect to fulfill the conditions of the four grants within one year, and these grants totaling RMB7.1 million ($1.1 million) were included in the current portion of deferred government grants, while the remaining one grant’s condition is expected to be fulfilled after 2021 and RMB8 million ($1.2 million) is recorded in the non-current portion of deferred government grants.
Critical Accounting Policies and Estimates
Our consolidated financial information has been prepared in accordance with U.S. GAAP, which requires us to make judgments, estimates and assumptions that affect (1) the reported amounts of our assets and liabilities, (2) the disclosure of our contingent assets and liabilities at the end of each fiscal period and (3) the reported amounts of revenues and expenses during each fiscal period. We continually evaluate these estimates based on our own historical experience, knowledge and assessment of current business and other conditions, our expectations regarding the future based on available information and reasonable assumptions, which together form our basis for making judgments about matters that are not readily apparent from other sources. Since the use of estimates is an integral component of the financial reporting process, our actual results could differ from those estimates. Some of our accounting policies require a higher degree of judgment than others in their application.
When reviewing our financial statements, you should consider (1) our selection of critical accounting policies, (2) the judgment and other uncertainties affecting the application of those policies and (3) the sensitivity of reported results to changes in conditions and assumptions. We believe the following accounting policies involve the most significant judgment and estimates used in the preparation of our financial statements.
Revenue from Contracts with Customers
We adopted ASC Topic 606 Revenue Recognition
from Contracts with Customers (“ASC 606”), on January 1, 2018, using the modified retrospective method.
Revenue is recognized when persuasive evidencecontrol of an arrangement exists, the pricepromised goods is fixed and determinable, delivery has occurred and there is a reasonable assurance of collection of the sales proceeds. We generally obtain purchase authorizations fromtransferred to our customers for a specifiedin an amount of products at a specified price and consider deliveryconsideration of which we expect to have occurred whenbe entitled to in exchange for the customer takes title of the products. We provide certain customers with a right of return.
Revenue for inactivated hepatitis A, combined inactivated hepatitis A&B, seasonal influenza and EV71 vaccines are recognized when delivery has occurredgoods, and we can reasonably estimates return provision for these products. the goods.
The product return provisions for inactivated hepatitis A vaccine and combined inactivated hepatitis A&B vaccine are estimated based on historical return and exchange data as well as the inventory levels and the remaining shelf lives of the products in the distribution channels. We started
As of December 31, 2020, sales return provision for our vaccine products was $12.1 million, compared to sell EV71 vaccines$3.7 million as of December 31, 2019. Sales return provision as a percentage of sales was 2.4% and 1.5% in 2016. 2020 and 2019, respectively.
For the year ended December 31, 2016, product return provision for enterovirus 71 vaccine was based2020, we did not have any significant incremental costs of obtaining contracts with customers incurred or costs incurred in fulfilling contracts with customers within the scope of ASC Topic 606, that shall be recognized as an asset and amortized to expenses in a pattern that matches the timing of the revenue recognition of the related contract.
We do not have amounts of contract assets since revenue is recognized as control of goods is transferred. The contract liabilities consist of advance payments from customers. The contract liabilities are reported in a net position on historical return and exchange dataa customer-by-customer basis at the end of similar products including hepatitis A and combined inactivated hepatitis A&B vaccines, as well as EV71 vaccines’ inventory levels and remaining shelf liveseach reporting period. All contract liabilities are included in deferred revenue in the distribution channels. We review the estimated sales return on an ongoing basis. This review indicated that our marketing and distributing strategy of EV71 vaccines shifted to a manner similar to inactivated hepatitis A vaccine, and no longer distributes the product in a manner similar to combined inactivated hepatitis A&B vaccine. Consolidated Balance Sheets.
For the year ended December 31, 2017, product return provision for EV71 vaccine was based on historical return and exchange data2020, we recognized sales of hepatitis A, as well as EV71 vaccines’ inventory levels and remaining shelf lives in the distribution channels. The change in estimate resulted in an increase$4.9 million related to income from continuing operations and net income attributable to shareholders of Sinovac of $8.1 million and $5.9 million, respectively. In addition, basic and diluted earnings per share both increased by $0.10.
As of December 31, 2017, sales return provision for inactivated hepatitis A vaccine, combined inactivated hepatitis A&B vaccine and EV 71 vaccine was $4.7 million, compared with $5.0 million as of December 31, 2016. Private pay sales return provision of inactivated hepatitis A vaccine, combined inactivated hepatitis A&B vaccine and EV71 vaccine as a percentage of sales was 3.1% and 10.9% in 2017 and 2016, respectively. We do not accept returns for hepatitis products sold under the EPI and exports. As such, no sales returns are estimated for these sales. Product return provision for seasonal influenza vaccines is estimated based on actual sales returns and expected sales returns up to the end of the flu season because we generally accept returns before the end of the flu season. As of December 31, 2017, sales return provision for seasonal influenza vaccine returns was approximately $0.3 million, compared with $0.5 million as of December 31, 2016.
Revenue for mumps vaccines without a right of return provided to customers is recognized when delivery has occurred. Revenue for mumps vaccines with a right of return provided to customers is recognized when payments are collected from customers.
Deferred revenue is generally relating to government stockpiling programs and advances received from customers. For government stockpiling programs of H5N1 vaccines, we generally obtain purchase authorizations from the government for a specified amount of productscontract liabilities at a specified price and no rights of return are provided. Revenue is recognized when the government takes delivery of the products. If the products expire prior to delivery, these expired products are recognized as revenue once cash is received and the products have expired and passed government inspection.
January 1, 2020.
Allowance for Doubtful Accounts
We adopted Accounting Standards Update (ASU) 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”) which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. We extend unsecured credit to our customers in the ordinary course of business but mitigate the associated risks by performing credit checks and actively pursuing past due accounts. An allowance for doubtful accounts is established and recorded based on management’s assessment of the credit history with the customer and current relationships with them.
We also maintain an allowance for doubtful accounts for estimated losses based on our assessment of the collectability of specific customer accounts and the aging of the accounts receivable. We analyze accounts receivable and historical bad debts, customer concentrations, customer solvency, current economic and geographic trends, and changes in customer payment terms and practices when evaluating the adequacy of our current and future allowance. In circumstances where we are aware of a specific customer’s inability to meet its financial obligations to us, a specific allowance for bad debt is estimated and recorded, which reduces the recognized receivable to the estimated amount we believe will ultimately be collected. We monitor and analyze the accuracy of the allowance for doubtful accounts estimate by reviewing past collectability and adjust it for future expectations to determine the adequacy of our current and future allowance. Our reserve levels have generally been sufficient to cover credit losses. As of December 31, 2017, the Company provided 100% (December 31, 2016 - 100%) allowance for accounts receivable aged more than four years, approximately 94.6% (December 31, 2016 - 84.8%) allowance for accounts receivable aged between three years and four years, approximately 68.5% (December 31, 2016 - 59.1%) allowance for accounts receivable aged between two years and three years, approximately 15.3% (December 31, 2016 - 20.5%) allowance for accounts receivable aged between one year and two years, and approximately 1.2% (December 31, 2016 - 1.4%) allowance for accounts receivable aged less than one year.
Our allowance for doubtful accounts as of December 31, 20172020 was $4.8$6.7 million, compared to $3.6$4.2 million as of December 31, 2016.2019. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required. Bad debt provision was $0.9$2.6 million for the year ended December 31, 20172020 as compared with a provisionrecovery of $1.4$0.3 million for the year ended December 31, 2016.
2019.
Inventory Provision
We write off all the unsold seasonal influenza vaccines before the end of the flu season at the end of the fiscal year, except for those distributed after the end of the fiscal year. In addition, we estimate an inventory provision for existing Healive, Bilive, Inlive, Anflu, Mumps, Varicella and MumpsCoronaVac products in inventory after considering the sales forecasts, the conditions of the raw material inventory, as well as the expiration dates of these products. The inventory provision in 2017, 20162020, 2019 and 20152018 was $1.2$5.8 million, $6.4$0.6 million and $1.8$2.5 million, respectively.
Impairment of Long-Lived Assets
Long-lived assets, including property, plant and equipment and intangible assets subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of an asset group may not be recoverable from the future undiscounted net cash flows expected to be generated by the asset group. An asset group is identified as assets at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets.
If the asset group is not fully recoverable, an impairment loss would be recognized for the difference between the carrying value of the asset group and its estimated fair value, based on the discounted net future cash flows or other appropriate methods, such as comparable market values. We use estimates and judgments in the impairment tests and the timing and amount of impairment charges could be materially different if different estimates or judgments are utilized. We did not record any impairment charges on long-lived assets in 2017, 20162020, 2019 and 2015.
2018.
Income Tax Valuation Allowance
In 2017,2020, we recorded $9.3$26.9 million of deferred income tax assets based on the difference in timing of certain deductions for income tax and accounting purposes. We evaluate our valuation allowance requirements at each reporting period by reviewing all available evidence, both positive and negative, and considering whether, based on the weight of that evidence, a valuation allowance is needed. When a change in circumstances causes a change in management’s judgment about the reliability of deferred tax assets, the impact of the change on the valuation allowance is generally reflected in income from operations. The future realization of the tax benefit of an existing deductible temporary difference ultimately depends on the existence of sufficient taxable income of the appropriate character within the carry forward period available under applicable tax law.
Recently Issued Accounting Standards
In May 2014,August 2020, the FASB issued ASU No. 2014-092020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2014-09”2020-06”), Revenue from Contracts with Customers (Topic 606), where a single, global revenue recognition model applies to most contracts with customers. Revenue will be recognized in a mannerwhich reduces the number of accounting models for convertible debt instruments and convertible preferred stock that depictssimplifies the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled, subject to certain limitations. In August 2015, the FASB issuedaccounting for convertible instruments. ASU 2015-14, where the2020-06 is effective date of ASU 2014-09 was extended to annual periodsfor fiscal years beginning after December 15, 2017. Early adoption is permitted. Subsequent to the issuance of ASU 2014-09, the FASB has issued several accounting standard updates such as ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients among others. These ASUs do not change the core principle of the guidance stated in ASU 2014-09, instead these amendments are intended to clarify and improve operability of certain topics included2021, including interim periods within the revenue standard. These ASUs will have the same effective date and transition requirements as ASU 2014-09. We adopted the new standard since January 1, 2018, using the modified retrospective method. We have completed the assessment and implementation work. Based on the work performed,the adoption of this guidance will not have a material impact on our consolidated financial statements or our internal controls over financial reporting.
In January 2016, the FASB issued ASU No. 2016-01 (“ASU 2016-01”), Financial Instruments. ASU 2016-01 requires separate presentation of financial assets and financial liabilities by measurement category and form of financial asset on the balance sheet or in the accompanying notes to the financial statements. That presentation provides financial statement users with more decision-useful information about an entity’s involvement in financial instruments. The guidance is effective for annual periods beginning after December 15, 2017.those fiscal years. Early adoption is permitted. We are currently evaluating the impact of adoption on its consolidated financial statements of adopting this standard.
In February 2016, the FASB issued ASU No. 2016-02 (“ASU 2016-02”), Leases. ASU 2016-02 requires recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases. The guidance is effective for annual periods beginning after December 15, 2018. Early adoption is permitted. We are currently evaluating the impact on its consolidated financial statements of adopting this standard.
In November 2016, the FASB issued ASU No. 2016-18 (“ASU 2016-18”), Statement of Cash Flows: Restricted Cash. ASU 2016-18 requires amounts generally described as restricted cash or restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning –of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for annual periods beginning after December 15, 2017. Early adoption is permitted. We adopted ASU 2016-18 on January 1, 2018, and does not expect the adoption of this standard will have a material impact on our consolidated financial statements.
RESULTS OF OPERATIONS
| Year ended December 31, |
| Year ended December 31, |
| |||||||||||||||||||||
| Consolidated statements of comprehensive income (loss) data | 2017 | 2016 | 2015 | |||||||||||||||||||||
Consolidated statements of comprehensive income data |
| 2020 |
|
| 2019 |
|
| 2018 |
| |||||||||||||||
| (in thousands except share and per share data) |
| (in thousands except share and per share data) |
| |||||||||||||||||||||
| Sales | $ | 174,346 | $ | 72,431 | $ | 67,414 |
| $ | 510,624 |
|
| $ | 246,053 |
|
| $ | 229,650 |
| ||||||
| Cost of sales(1) | 20,240 | 22,393 | 18,408 |
|
| 67,180 |
|
|
| 32,469 |
|
|
| 24,723 |
| |||||||||
| Gross profit | 154,106 | 50,038 | 49,006 |
|
| 443,444 |
|
|
| 213,584 |
|
|
| 204,927 |
| |||||||||
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||||
| Selling, general and administrative expenses(1) | 87,365 | 41,980 | 37,481 |
|
| 176,534 |
|
|
| 121,468 |
|
|
| 137,003 |
| |||||||||
| Provision (recovery) for doubtful accounts | 934 | 1,412 | (49 | ) |
|
| 2,640 |
|
|
| (306 | ) |
|
| 820 |
| ||||||||
| Research and development expenses(1) | 20,489 | 12,648 | 9,490 |
|
| 48,760 |
|
|
| 24,254 |
|
|
| 21,910 |
| |||||||||
| Loss on disposal and impairment of property, plant and equipment | 42 | 478 | 26 |
|
| 163 |
|
|
| 294 |
|
|
| 75 |
| |||||||||
| Government grants recognized in income | (141 | ) | (6,984 | ) | (1,637 | ) |
|
| (297 | ) |
|
| (688 | ) |
|
| (197 | ) | ||||||
| Total operating expenses | 108,689 | 49,534 | 45,311 |
|
| 227,800 |
|
|
| 145,022 |
|
|
| 159,611 |
| |||||||||
| Operating income | 45,417 | 504 | 3,695 |
|
| 215,644 |
|
|
| 68,562 |
|
|
| 45,316 |
| |||||||||
| Interest and financing expenses | (1,569 | ) | (1,729 | ) | (1,920 | ) |
|
| (1,453 | ) |
|
| (650 | ) |
|
| (1,070 | ) | ||||||
| Interest income | 1,183 | 731 | 1,155 |
|
| 1,930 |
|
|
| 1,996 |
|
|
| 2,016 |
| |||||||||
| Other income (expenses) | 13 | 100 | (174 | ) | ||||||||||||||||||||
| Income (loss) from continuing operations before income taxes | 45,044 | (394 | ) | 2,756 | ||||||||||||||||||||
Other income |
|
| 496 |
|
|
| 912 |
|
|
| 321 |
| ||||||||||||
Income before income taxes |
|
| 216,617 |
|
|
| 70,820 |
|
|
| 46,583 |
| ||||||||||||
| Income tax expenses | (8,339 | ) | (2,664 | ) | (2,985 | ) |
|
| (31,438 | ) |
|
| (5,605 | ) |
|
| (10,472 | ) | ||||||
| Income (loss) from continuing operations | 36,705 | (3,058 | ) | (229 | ) | |||||||||||||||||||
| Income (loss) from discontinued operations, net of tax nil | - | 2,338 | (728 | ) | ||||||||||||||||||||
| Net income (loss) | 36,705 | (720 | ) | (957 | ) | |||||||||||||||||||
| Less: (income) loss attributable to non-controlling interests | (10,898 | ) | 124 | (459 | ) | |||||||||||||||||||
| Net income (loss) attributable to shareholders of Sinovac | 25,807 | (596 | ) | (1,416 | ) | |||||||||||||||||||
| Comprehensive income (loss) | 44,803 | (9,563 | ) | (5,342 | ) | |||||||||||||||||||
| Less: comprehensive (income) loss attributable to non-controlling interests | (12,089 | ) | 953 | 82 | ||||||||||||||||||||
| Comprehensive income (loss) attributable to shareholders of Sinovac | $ | 32,714 | $ | (8,610 | ) | $ | (5,260 | ) | ||||||||||||||||
Net income |
|
| 185,179 |
|
|
| 65,215 |
|
|
| 36,111 |
| ||||||||||||
Less: income attributable to non-controlling interests |
|
| (74,810 | ) |
|
| (20,286 | ) |
|
| (14,329 | ) | ||||||||||||
Net income attributable to the shareholders of Sinovac |
|
| 110,369 |
|
|
| 44,929 |
|
|
| 21,782 |
| ||||||||||||
Preferred stock dividends |
|
| (6,015 | ) |
|
| (5,128 | ) |
|
| — |
| ||||||||||||
Net income attributable to common shareholders of Sinovac |
|
| 104,354 |
|
|
| 39,801 |
|
|
| 21,782 |
| ||||||||||||
Comprehensive income |
|
| 217,507 |
|
|
| 62,388 |
|
|
| 25,115 |
| ||||||||||||
Less: comprehensive income attributable to non-controlling interests |
|
| (82,892 | ) |
|
| (19,681 | ) |
|
| (12,507 | ) | ||||||||||||
Comprehensive income attributable to shareholders of Sinovac |
| $ | 134,615 |
|
| $ | 42,707 |
|
| $ | 12,608 |
| ||||||||||||
(1) | Includes share-based compensation of |
Sales
Revenues from sales represent: (1) the invoiced value of goods, net of value added taxes, and sales returns. See “Item 5. Operating and Financial Review and Prospects — A. Operating Results — Taxes and incentives.” We recognize revenues atwhen control of promised goods is transferred to our customers in an amount of consideration of which we expect to be entitled to in exchange for the time when our products are delivered, persuasive evidence of an arrangement exists,goods, and we can reasonably estimates return provision for the price is fixed and determinable and there is reasonable assurance of collection of the sales proceeds;goods.; and (2) the value of goods produced for government stockpiling program. We recognize revenues from the sales of products to the government stockpiling program when cash has been received and the products have expired and passed government inspection or are delivered per government instruction.
Our revenues, growth and results of operations depend on several factors, including the level of acceptance of our products among doctors, hospitals and vaccinees,patients, and our ability to maintain or increase prices for our products at levels that provide favorable margins. The level of acceptance among doctors, hospitals and vaccineespatients is influenced by the performance, promotion and academic research, and pricing of our products.
We market and sell our vaccine products primarily through provincial and municipal CDCs. We enter into sales agreements with CDCs each time a CDC places a purchase order. Pursuant to these sales agreements, CDCs typically agree not to re-sell our products to regions outside the territory the pertinent CDC covers administratively. Since hepatitis A vaccines were included into government sponsored expended immunization program in 2007, we have actively participated in the tender and bidding organized by various provincial CDCs. We enter into sales agreements with CDCs when we win a bid.
Pricing
In the private market, we set our price based on our production cost, the price of competitive products and acceptance level of CDCCDCs and vaccinees.patients. We also adjust our product price according to changes in the external environment to balance sales volume and gross profit, and ultimately to maximize sales profit margins.
In the public market, the government purchases vaccines for EPI market by issuing government tenders. During the evaluation process, price is a key factor which impacts the result of the tender. Therefore, we need to price our products competitively to win the tenders. We believe that our emphasis on product quality is an advantage and increases our competitiveness.
Cost of sales
Our cost of sales primarily consists of material, direct labor and production overheads. Depreciation of property, plant and equipment attributable to manufacturing activities and license amortization are capitalized as part of inventory, and expensed as cost of sales when product is sold. Cost of goods sold in 2017, 20162020, 2019 and 20152018 amounted to $20.2$67.2 million, $22.4$32.5 million and $18.4$24.7 million, respectively, of which idle capacity amounted to $2.8$1.7 million, $3.2$3.8 million and $2.2$2.7 million, respectively. We produce our products and conduct the final product packaging in-house.
Our production capacity has not been fully utilized. If we successfully commercialized new products and increase sales of existing products, we expect the unit production cost to decrease.
Selling, general and administrative expense
Selling and marketing expenses consist primarily of salaries and related expenses for personnel engaged in sales, marketing and customer support functions and costs associated with marketing activities and shipping. Selling expense increased 51.4% from $91.5 million in 2017 was $69.22019 to $138.6 million representing 39.7%in 2020, which accounted for 27.1% of total sales revenue of 2017, which is an 8.5% increase compared to 2016.
2020.
General and administrative expense consists primarily of compensation for employees in executive and operational functions, including finance and accounting, business development and human resources. Other significant costs include facilities costs, share-based compensation and professional fees for accounting and legal services.
Research and development expenses
Our research and development expenses consist primarily of:
• | salaries and related expenses for personnel; |
• | fees paid to consultants and clinical research organizations in conjunction with their independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials; |
• | consulting fees paid to third parties in connection with other aspects of our product development efforts; |
• | costs of materials used in research and development; |
• | depreciation of facilities and equipment used to develop our products; and |
• | technology license fees and milestone payments paid to third parties before a product receives regulatory approval. |
We expense both internal and external research and development costs as incurred, other than capital expenditures that have alternative future uses, such as the build-out of our plant, or license fees and milestone payments made to third parties after regulatory approval is received. We expect our research and development costs will continue to be substantial and that they will increase as we advance our current portfolio of product candidates through clinical trials and move other product candidates into pre-clinical and clinical trials.
Taxes and incentives
Sinovac Beijing, Sinovac R&D,LS, Sinovac Dalian and Sinovac Biomed are subject to income taxes in China on their taxable income calculated at a tax rate in accordance with the relevant income tax laws and regulations. Income tax returns filed by our PRC subsidiaries for tax years beginning in 20062010 have been subject to examination by tax authorities.
Effective from January 1, 2008, the PRC’s statutory income tax rate is 25%. The Company’sOur PRC subsidiaries aresubsidiary Sinovac Biomed is subject to income tax at the statutory rate of 25% except for. Sinovac Beijing and Sinovac Dalian. Sinovac Beijing, beingDalian, have been reconfirmed as a “High and New Technology Enterprise,” or HNTE in 20172020 for a period of 3 years;three years, and Sinovac Dalian, beingLS, has been confirmed as a HNTE in 20172020 for a period of 3three years, and accordingly each isare subject to a preferential income tax rate of 15% from 20172020 to 2019.2022. We determine deferred taxes for each tax-paying entity in each tax jurisdiction. The potential tax benefits arising from the losses incurred by the subsidiaries have been recorded in our financial statements.
We evaluate our valuation allowances requirements at each reporting period by reviewing all available evidence, both positive and negative, and considering whether, based on the weight of that evidence, a valuation allowance is needed. When a change in circumstances causes a change in management’s judgment about the realizability ofability to realize deferred tax assets, the impact of the change on the valuation allowance is generally reflected in income from operations. The future realization of the tax benefit of an existing deductible temporary difference ultimately depends on the existence of sufficient taxable income of the appropriate character within the carry forward period available under applicable tax law.
The valuation allowances relating to the deductible temporary differences and the unused tax losses of Sinovac R&D, Sinovac Dalian and Sinovac Biomed are still required as realization of these elements of the potential tax benefits is still uncertain. Taking the valuation allowances into account, the potential tax benefits arising from the deductible temporary differences and the unused tax losses of Sinovac R&D, Sinovac Dalian and Sinovac Biomed effectively have not been recorded in the financial statements. Tax losses of our PRC subsidiaries in the amount of $25.5RMB12.6 million (RMB166($1.9 million) as of December 31, 20172020 will expire from 20182021 to 2022,2030, if not utilized.
Year Ended December 31, 20172020 Compared to Year Ended December 31, 20162019
Sales. Total sales from continuing operations in 20172020 increased by 140.7%107.5% to $174.3$510.6 million from $72.4$246.1 million in 2016. Excluding revenue recognition of Panflu under the government stockpiling program in 2016 and 2015, regular sales of Healive, Bilive, Anflu, Inlive and mumps vaccine increased by 163.9% to $174.3 million in 2017 from $66.0 million in 2016.2019. The growth was mainly contributed by sales of Inlive.
CoronaVac.
The table below sets forth a breakdown of our sales by product:market type:
| Year ended December 31, | ||||||||
| Sales | 2017 | 2016 | ||||||
| (in thousands) | ||||||||
| Hepatitis A vaccine | $ | 27,421 | $ | 20,044 | ||||
| Hepatitis A&B vaccine | 10,430 | 552 | ||||||
| Influenza vaccines | 13,544 | 9,829 | ||||||
| EV71 vaccine | 121,284 | 35,140 | ||||||
| Mumps vaccines | 1,667 | 477 | ||||||
| Regular sales subtotal | 174,346 | 66,042 | ||||||
| H5N1 vaccine | - | 6,389 | ||||||
| Total sales | $ | 174,346 | $ | 72,431 | ||||
|
| Year ended December 31, |
| |||||
Sales |
| 2020 |
|
| 2019 |
| ||
|
| (in thousands) |
| |||||
EPI |
| $ | 96,799 |
|
| $ | 6,896 |
|
Private Pay |
|
| 268,821 |
|
|
| 220,217 |
|
Export |
|
| 145,004 |
|
|
| 18,940 |
|
Total sales |
| $ | 510,624 |
|
| $ | 246,053 |
|
Gross Profit.Gross profit from continuing operations in 20172020 increased by 208.0%107.6% to $154.1$443.4 million from $50.0$213.6 million in 2016.2019. Gross margin percentage increased to 88.4% in 2017 from 69.1% in 2016. Excluding86.8% was the impact of Panflu sales under the government-stockpiling program in 2017 and 2016, gross margin increased to 88.4% in 2017 from 70.0% in 2016. The increase of gross margin was mainly due to higher gross profit on Inlive and lower inventory provision charged to Bilive vaccines in 2017.same compared with last year.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses in 20172020 increased by 108.1%45.3% to $87.4$176.5 million from $42.0$121.5 million in 2016.2019. The increase was mainly due to higher selling expenses incurred on promotion of Inlivesales and higher professional and consulting fees related to the proposed privatization.
marketing dedicated for revenue growth.
We recorded total share-based compensation of $1.0$10.2 million in 2017,2020, compared to $2.4$3.0 million in 2016.2019. As of December 31, 2017,2020 and 2019, we had unrecognized compensation costs of $2.3 million.$6.6 million and $9.6 million, respectively. This unearned component will be recognized over a period of 2826 months.
Research and Development Expenses. Research and development expenses in 2017,2020, primarily represented expenditures on the advancement of pipeline vaccines, including pneumococcal vaccines, sIPV and COVID-19 vaccines, increased by 101.0% to $48.8 million from $24.3 million in 2019.
Interest and Financing Expenses. Interest and financing expense increased by 123.5% to $1.5 million from $0.7 million in 2019.
Income Tax Expenses. Income tax expense was $31.4 million in 2020, compared to an income tax expenses of $5.6 million in 2019.
Net Income. Net income was $185.2 million in 2020, compared to $65.2 million in 2019. Net income attributable to shareholders of Sinovac was $110.4 million in 2020, compared to $44.9 million in 2019. Net income attributable to common shareholders of Sinovac was $104.4 million in 2020, compared to $ 39.8 million in 2019.
Year Ended December 31, 2019 Compared to Year Ended December 31, 2018
Sales. Total sales in 2019 increased by 7.1% to $246.1 million from $229.7 million in 2018. Revenue recognition of Panflu under the government stockpiling program in 2019 and 2018 were nil. The growth was mainly contributed by sales of mumps vaccines and Anflu.
The table below sets forth a breakdown of our sales by market type:
|
| Year ended December 31, |
| |||||
Sales |
| 2019 |
|
| 2018 |
| ||
|
| (in thousands) |
| |||||
EPI |
| $ | 6,896 |
|
| $ | 10,357 |
|
Private Pay |
|
| 220,217 |
|
|
| 204,764 |
|
Export |
|
| 18,940 |
|
|
| 14,529 |
|
Total sales |
| $ | 246,053 |
|
| $ | 229,650 |
|
Gross Profit. Gross profit in 2019 increased by 4.2% to $213.6 million from $204.9 million in 2018. Gross margin percentage decreased to 86.8% in 2019 from 89.2% in 2018. The decrease of gross margin was mainly due to lower gross profit on Anflu in 2019.
Selling, General and Administrative Expenses. Selling, general and administrative expenses in 2019 decreased by 11.3% to $121.5 million from $137.0 million in 2018. The decrease was mainly due to lower professional and consulting fees associated with ongoing litigations.
We recorded total share-based compensation of $3.0 million in 2019, compared to $4.3 million in 2018. As of December 31, 2019 and 2018, we had unrecognized compensation costs of $9.6 million and $12.6 million, respectively. This unearned component will be recognized over a period of 38 months.
Research and Development Expenses. Research and development expenses in 2019, primarily represented expenditures on the advancement of pipeline vaccines, including pneumococcal vaccines, sIPV and varicella vaccine, increased by 10.7% to $20.5$24.3 million from $21.9 million in 2017 from $12.6 million in 2016.2018.
Interest and Financing Expenses. Interest and financing expense decreased by 9.3%39.3% to $1.6$0.7 million from $1.1 million in 2017 from $1.7 million in 2016.2018. There were $nil, $nil and $0.3 million and $37,000 of interest subsidies received in 2019, 2018 and 2017, and 2016, respectively.
Income Tax Expenses. Income tax expense was $8.3$5.6 million in 2017,2019, compared to an income tax expense of $2.7$10.5 million in 2016.2018.
Income (loss) from Continuing Operations. Income from continuing operationsNet Income. Net income was $36.7$65.2 million in 2017,2019, compared to a loss of $3.1$36.1 million in 2016.
Income (loss) from Discontinued Operations. Income from discontinued operations was nil in 2017, compared to an income of $2.3 million in 2016. The income from discontinued operations in 2016 was a result of completion of the disposal transaction of Tangshan Yian.
Net Income.2018. Net income attributable to shareholders of Sinovac was $25.8$44.9 million in 2017,2019, compared to a net loss of $0.6$21.8 million in 2016.
Year Ended December 31, 2016 Compared2018. Net income attributable to Year Ended December 31, 2015
Sales. Total sales from continuing operations in 2016 increased by 7.4% to $72.4 million from $67.4 million in 2015. Excluding revenue recognition of Panflu under the government stockpiling program in 2016 and 2015, regular sales of Healive, Bilive, Anflu, Inlive and mumps vaccine increased by 3.9% to $66.0 million in 2016 from $63.6 million in 2015. The growth was mainly contributed by sales of Inlive.
The table below sets forth a breakdown of our sales by product:
| Year ended December 31, | ||||||||
| Sales | 2016 | 2015 | ||||||
| (in thousands) | ||||||||
| Hepatitis A vaccine | $ | 20,044 | $ | 26,801 | ||||
| Hepatitis A&B vaccine | 552 | 22,615 | ||||||
| Influenza vaccines | 9,829 | 12,674 | ||||||
| EV71 vaccine | 35,140 | - | ||||||
| Mumps vaccines | 477 | 1,472 | ||||||
| Regular sales subtotal | 66,042 | 63,562 | ||||||
| H5N1 vaccine | 6,389 | 3,852 | ||||||
| Total sales | $ | 72,431 | $ | 67,414 | ||||
Gross Profit. Gross profit from continuing operations in 2016 increased by 2.1% to $50.0 million from $49.0 million in 2015. Gross margin percentage decreased to 69.1% in 2016 from 72.7% in 2015. Excluding the impact of Panflu sales under the government-stockpiling program in 2016 and 2015, gross margin decreased to 70.0% in 2016 from 73.4% in 2015. The decrease of gross margin was mainly due to higher inventory provision of Bilive vaccines in 2016.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses in 2016 increased by 12.0% to $42.0 million from $37.5 million in 2015. The increase was mainly due to higher selling expenses incurred on promotion of EV71 and higher professional and consulting fees related to the proposed privatization.
We recorded total share-based compensation of $1.5 million in 2016, compared to $0.6 million in 2015. As of December 31, 2016, we had unrecognized compensation costs of $3.3 million. This unearned component will be recognized over a period of 40 months.
Research and Development Expenses. Research and development expenses in 2016, primarily represented expenditures on the advancement of pipeline vaccines, including pneumococcal vaccines, sIPV and varicella vaccine, increased to $12.6 million in 2016 from $9.5 million in 2015.
Interest and Financing Expenses.Interest and financing expense decreased by 9.9% to $1.7 million in 2016 from $1.9 million in 2015. The decrease in interest and financing expense is primarily due to lower interest rates on outstanding loans during 2017 compared to 2016. There were $37,000 and $0.1 million of interest subsidies received in 2016 and 2015, respectively.
Income Tax Expenses. Income tax expense was $2.7 million in 2016, compared to an income tax expense of $3.0 million in 2015.
Income (loss) from Continuing Operations. Loss from continuing operations was $3.1 million in 2016, compared to a loss of $0.2 million in 2015.
Income (loss) from Discontinued Operations. Income from discontinued operations was $2.3 million in 2016, compared to a loss of $0.7 million in 2015. The income from discontinued operations in 2016 was a result of completion of the disposal transaction of Tangshan Yian.
Net Loss.Net loss attributable tocommon shareholders of Sinovac Antigua was $0.6$39.8 million in 2016,2019, compared to a net loss of $1.4$ 21.8 million in 2015.
We finance our operations primarily through short-term and long-term borrowings, proceeds from public offerings, capital raised in private placements, 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. If our existing cash is insufficient to meet our requirements, we may seek to sell additional equity securities, debt securities or borrow from banks.
2018.
Cash Flows and Working Capital
The following table sets forth a summary of our net cash flows for the periods indicated:
| Year ended December 31, | ||||||||||||
| 2017 | 2016 | 2015 | ||||||||||
| (in thousands) | ||||||||||||
| Net cash provided by (used in) operating activities | $ | 61,354 | $ | (15,459 | ) | $ | 4,211 | |||||
| Net cash used in investing activities | (11,896 | ) | (11,776 | ) | (4,515 | ) | ||||||
| Net cash provided by (used in) financing activities | (1,342 | ) | 27,784 | (24,196 | ) | |||||||
| Effect of exchange rate changes on cash and cash equivalents, including cash classified within current assets held for sale | 3,865 | (2,092 | ) | (1,541 | ) | |||||||
| Decrease in cash and cash equivalents, including cash classified within current assets held for sale | 51,981 | (1,543 | ) | (26,041 | ) | |||||||
| Less: Net decrease in cash classified within current assets held for sale | - | (143 | ) | (82 | ) | |||||||
| Increase (decrease) in cash and cash equivalents | 51,981 | (1,400 | ) | (25,959 | ) | |||||||
| Cash and cash equivalents at beginning of period | 62,434 | 63,834 | 89,793 | |||||||||
| Cash and cash equivalents at end of period | $ | 114,415 | $ | 62,434 | $ | 63,834 | ||||||
|
| Year ended December 31, |
| |||||||||
|
| 2020 |
|
| 2019 |
|
| 2018 |
| |||
|
| (in thousands) |
| |||||||||
Net cash provided by operating activities |
| $ | 479,309 |
|
| $ | 39,074 |
|
| $ | 7,943 |
|
Net cash used in investing activities |
|
| (204,756 | ) |
|
| (42,454 | ) |
|
| (25,261 | ) |
Net cash provided by financing activities |
|
| 592,566 |
|
|
| 1,737 |
|
|
| 64,180 |
|
Effect of exchange rate changes on cash and cash equivalents and restricted cash |
|
| 27,207 |
|
|
| (649 | ) |
|
| (4,656 | ) |
Increase (decrease) in cash and cash equivalents and restricted cash |
|
| 894,326 |
|
|
| (2,292 | ) |
|
| 42,206 |
|
Cash and cash equivalents and restricted cash at beginning of period |
|
| 155,878 |
|
|
| 158,170 |
|
|
| 115,964 |
|
Cash and cash equivalents and restricted cash at end of period |
| $ | 1,050,204 |
|
| $ | 155,878 |
|
| $ | 158,170 |
|
Operating Activities
Net cash provided by operating activities was $61.4$479.3 million in 2017, compared to net cash used in operating activities of $15.5 million in 2016. Net cash provided by our operating activities in 2017 resulted primarily from (1) our net income from continuing operations of $36.7 million, (2) deferred income taxes of $4.9 million, (3) depreciation of property, plant and equipment and amortization of prepaid land lease payments of $4.9 million, (4) a decrease of accounts receivable of $13.5 million and an increase in accounts payables and accrued liabilities of $33.4 million.
Net cash used in operating activities was $15.5 million in 2016,2020, compared to net cash provided by operating activities of $4.2$39.1 million in 2015.2019. Net cash used inprovided by our operating activities in 20162020 resulted primarily from (1) our net loss from continuing operations of $3.1 million, (2) inventory provision of $6.4 million, (3) depreciation of property, plant and equipment and amortization of prepaid land lease payments of $5.3 million, (4) government grants recognized in income of $7.0$185.2 million and (5) a decrease ofan increase in deferred revenue of $5.0$339.3 million, partially offset by an increase of inventory of $77.7 million.
Net cash provided by operating activities was $39.1 million in 2019, compared to net cash provided by operating activities of $7.9 million in 2018. Net cash provided by our operating activities in 2019 resulted primarily from our net income of $65.2 million and an increase in accounts payable and accrued liabilities of $6.8 million, partially offset by an increase of accounts receivable of $15.1$40.2 million.
Investing Activities
Net cash used in investing activities was $11.9$204.8 million in 2017,2020, compared to $11.8$42.5 million in 2016.2019. We invested primarily in the construction of our sIPV production facilitiesshort-term investments and property, plant and equipment in 2017.
2020.
Net cash used in investing activities was $11.8$42.5 million in 2016,2019, compared to $4.5$25.3 million in 2015.2018. We invested more cashprimarily in the construction of our PPV and sIPV production facilitiesshort-term investments in 2016.
2019
Financing Activities
Net cash used in financing activities was $1.3 million in 2017 compared to net cash provided by financing activities was $27.8 million in 2016. In 2017, net cash provided by our financing activities included net proceeds of $1.3 million from issuance of common shares and government funding of $2.6 million. We also received loan proceeds of $28.6 million and made loan repayments of $38.7 million in 2017.
Net cash provided by financing activities was $27.8$592.6 million in 20162020, compared to net cash used in financing activities of $24.2$1.7 million in 2015.2019. In 2016, net cash provided by our financing activities included net2020, we received proceeds of $0.3$541.0 million from issuance of common shares and government funding of $6.9 million. We also receiveda subsidiary’s financing activities, loan proceeds of $45.5$33.2 million and made loan repayments of $24.9$6.0 million.
Net cash provided by financing activities was $1.7 million in 2016.
2019, compared to $64.2 million in 2018. In 2019, we received loan proceeds of $2.1 million and made loan repayments of $3.3 million.
Accounts Receivable
Our total accounts receivable, including other receivables, increased by $16.4 million122.9% from $49.8$113.7 million as of December 31, 20162019 to $66.2$253.5 million as of December 31, 2017.2020. Our average accounts receivable turnover time in 20172020 was 127134 days, as compared to 256144 days in 2016.
2019.
Our maximum exposure to credit risk at the balance sheet dates relating to accounts receivables is summarized as follows:
| Year ended December 31, |
| Year ended December 31, |
| |||||||||||||
| 2017 | 2016 |
| 2020 |
|
| 2019 |
| |||||||||
| (in thousands) |
| (in thousands) |
| |||||||||||||
| Aging within one year, net of allowance for doubtful accounts | $ | 58,157 | $ | 45,340 |
| $ | 240,266 |
|
| $ | 108,635 |
| ||||
| Aging greater than one year, net of allowance for doubtful accounts | 6,512 | 3,118 |
|
| 10,365 |
|
|
| 3,462 |
| ||||||
| Total trade receivable — net | $ | 64,669 | $ | 48,458 | ||||||||||||
Total trade receivable |
| $ | 250,631 |
|
| $ | 112,097 |
| ||||||||
Borrowings
As of December 31, 2017,2020, we had $18.2$32.9 million in short-term bank loans, offset by $114.4$1,041.0 million in cash and cash equivalents, resulting in a liquid assets balance of $96.3$1,008 million, compared with $31.1$146.8 million at the end of December 31, 2016.2019. The following tables summarize our short-term and long-term bank borrowings as of December 31, 2017:2020:
Type | Amount | Annual Interest Rate | Interest Payment | Maturity Date | Purpose | |||||||||||||||||||
Bank loan from Bank of | RMB7 million ($1.1 million) | 5.00 | % | monthly | March 13, 2021 | operation | ||||||||||||||||||
Bank loan from Bank of | RMB6 million ($0.9 million) | 4.40 | % | monthly | December 9, 2021 | operation | ||||||||||||||||||
Bank loan from SPD Silicon Valley Bank | RMB42.4 million ($6.5 million) | 5.10 | % | quarterly | On or before August 6, 2021 | operation | ||||||||||||||||||
Bank loan from Guangdong Development Bank | RMB9.0 million ($1.4 million) | 5.00 | % | monthly | On or before November 29, 2021 | operation | ||||||||||||||||||
Bank loan from China Merchants Bank | RMB0.7 million ($0.1 million) | 5.60 | % | monthly | December 31, 2021 | mortgage | ||||||||||||||||||
Bank loan from China Merchants Bank | RMB1.6 million ($0.2 million) | 5.60 | % | monthly | May 26, 2023 | mortgage | ||||||||||||||||||
Bank loan from China Everbright Bank | RMB13.0 million ($2.0 million) | 5.88 | % | quarterly | November 16, 2028 | purchase of | ||||||||||||||||||
On September 18, 2015,November 20, 2019, Sinovac BeijingDalian entered into a maximum credit facility of RMB50RMB20 million ($7.23.1 million) with Bank of BeijingChina to finance its working capital requirements. RMB4.9RMB7 million ($0.81.0 million) was drawn on August 29, 2017December 24, 2019 and will be duewas repaid on August 29, 2018. RMB5.1December 24, 2020. On March 13, 2020, Sinovac Dalian withdrew RMB7 million ($0.8 million) was drawn on September 6, 2017 and will be due on August 29, 2018. RMB10 million ($1.5 million) was drawn on October 13, 2017 and will be due on October 13, 2018. RMB4 million ($0.6 million) was drawn on November 9, 2017 and will be due on October 13, 2018.
On May 20, 2015, Sinovac Beijing entered into a bank loan with Bank of Beijing in the aggregate principal amount of RMB48 million ($7.41.1 million) with a term from July 2015 to May 2020 for construction of the PPV facilities. The loan’san annual interest rate is based onat 95 basis point above the prime rate of a five-yearone year term loan published by the People’s Bank of China, at the time withdraws are made. Interest is payable quarterly and the loan should be repaid in accordance with a repayment schedule and fully repaid before May 20, 2020. RMB4.95.00%. On December 9, 2020, Sinovac Dalian withdrew RMB 6 million ($0.80.9 million) was drawn in 2015 with an annual interest rate of 5.25%, and RMB39.7 million ($6.1 million) was drawn in 2016 with an annual interest rate of 4.75%. Prepaid land lease payments and buildings of Sinovac Beijing with a net book value of RMB15.5 million ($2.4 million) were pledged as collateral as of December 31, 2017.
On March 27, 2017, Sinovac R&D entered into a bank loan with China Construction Bank in the aggregate principal amount of RMB4.7 million ($0.7 million) to finance its working capital requirements, bearing interest at 5%55 basis point above the prime rate of a one-yearone year term loan published by the People’s Bank of China, at 4.43%4.40%. Interest is payable monthly and the loan was repaidloans are repayable on March 26, 2018. Cash collateral13, 2021 and December 9, 2021, respectively. Buildings of Sinovac R&DDalian with a net book value of RMB5RMB 16.1 million ($0.8 million) was pledged as collateral, which has been released after the loan was fully repaid.
On May 6, 2015, Sinovac Beijing entered into a maximum credit facility of RMB120 million ($17.2 million) with China Construction Bank to finance its working capital requirements. On May 18, 2017, Sinovac Beijing renewed the credit facility to RMB200 million ($30.7 million). On September 5, 2017, Sinovac Beijing entered into a bank loan with China Construction Bank in the aggregate principal amount of RMB19.4 million ($3.0 million) to finance its working capital requirements, bearing interest at 0.27% above the prime rate of a one-year term loan published by the People’s Bank of China, at 4.57%. Interest is payable monthly and the loan is payable on September 4, 2018. RMB19.4 million ($3.0 million) was drawn on September 5, 2017 and will be due on September 4, 2018.
On August 17, 2017, Sinovac Beijing entered into a bank loan with China Construction Bank in the aggregate principal amount of $3,074 (RMB20 million) with a term from August 2017 to October 2021. The loan bears interest at prime rate of a five-year term loan published by the People’s Bank of China, adjusted every 12 months, currently at 4.75%. Interest is payable quarterly and the loan is payable based on the payment schedule and fully repay before October 21, 2021. RMB2.0 million ($0.3 million) was drawn in 2017. RMB0.8 million ($0.1 million) and RMB1.2 million ($0.2 million) are payable on February 25, 2019 and August 25, 2019, respectively.
On May 6, 2015, Sinovac Beijing entered into a maximum credit facility of RMB70 million ($10.8 million) with China Construction Bank to finance construction of the Sabin inactivated polio vaccine facilities. On October 14, 2016, Sinovac Beijing entered into a bank loan with China Construction Bank in the aggregate principal amount of RMB50 million ($7.7 million) with a term from October 2016 to October 2021. The loan bears interest at 5% below the prime rate of a five-year term loan published by the People’s Bank of China, adjusted every 12 months, currently at 4.51%. Interest is payable quarterly and the loan is payable based on the payment schedule and fully repay before October 13, 2021. RMB21.0 million ($3.2 million) was drawn in 2016 and RMB29.0 million ($4.5 million) was drawn in 2017.
Pursuant to the covenants set out in these two bank loan agreements with China Construction Bank, Sinovac Beijing’s debt to total assets ratio must not be higher than 80%, current ratio must not be lower than 0.8, contingent liabilities must not be higher than RMB235 million ($36.1 million) and contingent liabilities as a percentage of total shareholders’ equity must not be higher than 50%. We were in compliance with such covenants as of December 31, 2017. Prepaid land lease payment and buildings of the Changping facilities of Sinovac Beijing with a net book value of RMB94.5 million ($14.52.5 million) were pledged as collateral against the loan as of December 31, 2017.a collateral.
On February 23, 2017,November 25, 2019, Sinovac Beijing entered into a one-year term bank loan with China Merchants Bank in the aggregate principal amount of RMB20 million ($3.1 million) to finance its working capital requirements, bearing interest at 5% above the prime rate of a one-year term loan published by the People’s Bank of China, at 4.57% per year. Interest was payable quarterly. The loan was guaranteed by an unrelated third party, with a guarantee fee of RMB0.4 million ($59,000) over the term of the loan. Trade receivables of Sinovac Beijing with a carrying value of not lower than RMB35 million ($5.4 million) were pledged as collateral. The loan was repaid on February 22, 2018.
On May 9, 2016, Sinovac BeijingDalian entered into a revolving bank loan with CitiSPD Silicon Valley Bank inwith the aggregate principal limit of RMB30RMB50 million ($4.67.7 million) to finance its working capital requirements. The revolving loan bears interest at 125 basis points above the prime rate of a one-year term loan published by the People’s Bank of China, with a weighted average rate at 4.47%5.1% and interest is payable quarterly. Each withdraw from the revolving loan has a maximum term of 12 months. RMB4RMB7.6 million ($0.61.1 million) was drawn in 2019 and repaid in December 2020. The outstanding balance of RMB42.4 million ($6.5 million) was drawn during 2020 and is payable on or before August 6, 2021.
On November 5, 2020, Sinovac Dalian entered into a maximum credit facility of RMB9 million ($1.4 million) with Guangdong Development Bank to finance its working capital requirements. RMB9.0 million ($1.4 million) was drawn during 2020 and payable on or before November 29, 2021. The loan bears interest at 115 basis point above the prime rate of a one year term loan published by the People’s Bank of China, at 5% and interest is payable monthly. Prepaid land lease payments of Sinovac Dalian with a net book value of RMB14.3 million ($2.2 million) were pledged as collateral.
On May 26, 2020, Sinovac Dalian entered into four mortgages in the total amount of RMB2.1 million ($0.3 million) with China Merchants Bank to purchase four apartments. The loans bear annual interest rate at 175 basis point above the prime rate of a one year term loan published by the People’s Bank of China, at 5.6%. Principals and interests are repaid monthly over a term of 36 months. Sinovac Dalian repaid RMB0.4 million ($58,000) in principal and interest in 2020. As of December 31, 2020, RMB0.7 million ($0.1 million) is recorded in bank loans due within one year and RMB1.1 million ($0.2 million) is recorded in long-term bank loans.
On November 17, 2020, Sinovac Dalian entered into a maximum credit facility of RMB 200 million ($30.7 million) is to finance Sinovac Dalian’s purchase of property plant and equipment, with a term from November 17, 2020 to November 16, 2028. The loan bears annual interest rate at 123 basis point above the prime rate of a five year term loan published by the People’s Bank of China, at 5.88%. Interest is payable quarterly and principal installment repayments begin in 2023 and shall be fully paid by November 16, 2028. Certain plant and machinery and equipment of
Sinovac Dalian with a net book value of RMB150.2 million ($23.1 million) were pledged as collateral. Sinovac Dalian withdrew RMB13 million ($2.0 million) on December 14, 2020 and will be repaid during 2023 to 2028.
Type | Amount | Annual Interest Rate | Interest Payment | Maturity Date | Purpose | |||||||
Bank loan from Bank of Beijing | RMB30 million ($4.6 million) | 3.05 | % | quarterly | March 31, 2021 | operation | ||||||
Bank loan from SPD Silicon Valley Bank | RMB49.9 million ($7.7 million) | 5.05 | % | quarterly | On or before October 15, 2021 | operation | ||||||
Bank loan from SPD Silicon Valley Bank | RMB69.9 million ($10.7 million) | 5.05 | % | quarterly | On or before October 15, 2021 | operation | ||||||
On March 31, 2020, Sinovac LS entered into a maximum credit facility of RMB30 million ($4.6 million) with Bank of Beijing to finance its working capital requirements. RMB30 million ($4.6 million) was drawn on November 13, 2017March 31, 2020 with an annual interest rate of 3.05%. Interest is payable monthly and was repaidthe loan is payable on JanuaryMarch 31, 2021.
On May 14, 2020 and September 3, 2020, Sinovac LS entered into two revolving bank loans with SPD Silicon Valley Bank with the aggregate principal of RMB50 million ($7.7 million)and RMB70 million ($10.7 million), respectively, to finance its working capital requirements. The revolving loan bears interest at 120 basis points above the prime rate of a one-year term loan published by the People’s Bank of China, with a weighted average rate at 5.05% and interest is payable quarterly. Each withdraw from the revolving loans has a maximum term of 12 2018. RMB4months. The outstanding balance of RMB119.8 million ($0.618.4 million) was drawn during 2020 and is payable on November 14, 2017 and was repaid on January 12, 2018. RMB2 million ($0.3 million) was drawn on November 14, 2017 and was repaid on January 12, 2018. RMB8 million ($1.2 million) was drawn on November 22, 2017 and was repaid on January 22, 2018. RMB4.5 million ($0.7 million) was drawn on December 13, 2017 and was repaid on February 12, 2018. RMB4.3 million ($0.7 million) was drawn on December 14, 2017 and was repaid on February 13, 2018. RMB3.1 million ($0.5 million) was drawn on December 20, 2017 and was repaid on February 22, 2018.
or before October 15, 2021.
Our weighted average effective interest rate on outstanding borrowings was 4.61%4.84%, 4.73%5.09% and 4.83%4.91% for the years ended December 31, 2017, 20162020, 2019 and 2015,2018, respectively. We have not historically used, and do not expect to use in the future, any derivative financial instruments to manage our exposure to interest risk.
Restrictions on Cash Dividends
We are a holding company, and we rely in part on dividends paid by our subsidiaries, Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS and Sinovac Biomed for our cash needs, mainly our operating expenses. The payment of dividends in China is subject to limitations. Regulations in the PRC currently permit payment of dividends only out of accumulated profits as determined in accordance with accounting standards and regulations in China. Our subsidiary is also required to set aside at least a portion of its after-tax profit based on PRC accounting standards each year to fund the statutory surplus reserves.
The reserves can be used to recoup previous years’ losses, if any, and, subject to the approval of the relevant PRC government authority, may be converted into share capital in proportion to their existing shareholdings, or by increasing the par value of the shares currently held by them. Such reserves, however, are not distributable as cash dividends. In addition, at discretion of their board of directors, our subsidiaries may allocate a portion of their after-tax profits based on PRC accounting standards to the employee welfare and bonus funds, which shall be utilized for collective staff benefits. In addition, if Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS or Sinovac Biomed incurs debt on its own behalf in the future, the instruments governing the debt may restrict the ability of one or more of our PRC subsidiaries, as the case may be, to pay dividends or make other distributions to us.
The ability of our subsidiary to convert renminbi into U.S. dollars and make payments to us is subject to PRC foreign exchange regulations. Under these regulations, the renminbi is convertible for current account items, including the distribution of dividends, interest payments, trade and service-related foreign exchange transactions. Conversion of renminbi for capital account items, such as direct investment, loan, security investment and repatriation of investment, however, is still subject to the approval of SAFE. See “Item 10. Additional Information — D. Exchange Controls.”
The ability of our subsidiary to distribute dividends requires the financial management team to have operating control of the bank accounts of Sinovac Beijing. While that control exists today, as described above, a representative of Sinobioway Medicine and dozens of unidentified individuals forcibly entered Sinovac Beijing’s corporate offices on April 17, 2018 and limited the physical movements of employees in Sinovac Beijing’s general manager’s office and finance department in an attempt to take control of Sinovac Beijing’s official seal, legal documents, accounting seal, financial documents and financial information systems.
Capital Expenditures
We made capital expenditures of $11.9$127.7 million, $12.7$10.6 million and $5.3$5.6 million in 2017, 20162020, 2019 and 2015,2018, respectively. In 2017, we made $11.9 million of payments towards property, plant and equipment for construction of PPV, sIPV and varicella production facilities. As of December 31, 2017,2020, our commitments related to capital expenditures of approximately $0.1$45.3 million were primarily for the construction of our sIPV and varicellaCOVID-19 vaccine production facilities. We will finance such commitments through long-term borrowings, proceeds from our public offerings and cash generated from operations.
C. |
Research and Development, Patents and Licenses, Etc. |
See discussions under “Item 5. Operating and Financial Review and Prospects — A. Operating Results — Research and Development Programs.”
D. | Trend Information |
Other than as disclosed elsewhere in this annual report, we are not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 20172020 to December 31, 20172020 that are reasonably likely to have a material adverse effect on our net revenues, income, profitability, liquidity or capital resources, or that caused the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
E. | Off-Balance Sheet Arrangements |
We do not, and did not, have any interest in variable interest entities or any other off-balance sheet arrangements that require disclosure.
F. | Tabular Disclosure of Contractual Obligations |
The following table summarizes our estimated contractual obligations and commitments as of December 31, 20172020 for the periods indicated:
| Payments due by period | ||||||||||||||||||||||||||||||||||||||||
| Total | Less than 1 year | 1 – 3 years | 4 – 5 years | More than 5 years |
| Total |
|
| Less than 1 year |
|
| 2-3 years |
|
| 4-5 years |
|
| More than 5 years |
| |||||||||||||||||||||
| (in thousands) |
| (in thousands) |
| |||||||||||||||||||||||||||||||||||||
| Debt obligations including amount owing to related party (including interest) | 42,967 | 19,584 | 15,101 | 8,282 | - |
| $ | 50,282 |
|
| $ | 40,878 |
|
| $ | 7,134 |
|
| $ | 851 |
|
| $ | 1,419 |
| |||||||||||||||
| R&D expenses, liabilities and commitment | 2,158 | 2,158 | - | - | - |
|
| 3,886 |
|
|
| 3,886 |
|
|
| — |
|
|
| — |
|
|
| — |
| |||||||||||||||
| Operating lease obligations | 9,980 | 427 | 1,586 | 1,586 | 6,381 |
|
| 114,403 |
|
|
| 7,700 |
|
|
| 21,366 |
|
|
| 21,907 |
|
|
| 63,430 |
| |||||||||||||||
| Purchase of facilities commitments | 112 | 112 | - | - | - |
|
| 45,306 |
|
|
| 45,306 |
|
|
| — |
|
|
| — |
|
|
| — |
| |||||||||||||||
| Accounts payable and accrued liabilities | 59,418 | 59,418 | - | - | - |
|
| 211,428 |
|
|
| 211,428 |
|
|
| — |
|
|
| — |
|
|
| — |
| |||||||||||||||
| Total | 114,635 | 81,699 | 16,687 | 9,868 | 6,381 |
| $ | 425,305 |
|
| $ | 309,198 |
|
| $ | 28,500 |
|
| $ | 22,758 |
|
| $ | 64,849 |
| |||||||||||||||
G. | Safe Harbor |
This annual report on Form 20-F contains forward-looking statements that relate to future events, including our future operating results and conditions, our prospects and our future financial performance and condition, all of which are largely based on our current expectations and projections. The forward-looking statements are contained principally in the sections entitled “Item 3. Key Information — D. Risk Factors,” “Item 4. Information on the Company” and “Item 5. Operating and Financial Review and Prospects.” These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as “may,” “will,” “expect,” “anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,” “is/are likely to” or other and similar expressions. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following:
• | our ability to maximize sales of our existing products within the Chinese market; |
• | our ability to develop new vaccines; |
• | our ability to improve our existing vaccines and lower our production costs; |
• | our ability to expand our manufacturing facilities to meet the needs of the growing Chinese market and other geographic markets; |
• | our ability to acquire new technologies and products; |
• | uncertainties in and the timeliness of obtaining necessary governmental approvals and licenses for marketing and sale of our vaccines in certain overseas markets; |
• | our ability to compete successfully against our competitors; |
• | risks associated with our corporate structure and the regulatory environment in China; |
• | ongoing litigation between our Company and certain of our shareholders; and |
• | other risks outlined in our filings with the Securities and Exchange Commission |
The forward-looking statements made in this annual report on Form 20-F relate only to events or information as of the date on which the statements are made in this annual report on Form 20-F. Except as required by law, we undertake no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this annual report on Form 20-F completely and with the understanding that our actual future results may be materially different from what we expect.
A. | Directors and Senior Management |
The following table sets forth information regarding our directors and executive officers as of the date of this annual report:
Directors and Executive Officers | Age | Position/Title | ||
Weidong Yin | 57 | Chairman, President, Chief Executive Officer | ||
Simon Anderson(1) (2) (3) | 59 | Independent Director | ||
Yuk Lam Lo(1) (2) (3) | 71 | Independent Director | ||
Kenneth Lee(2) (3) | 52 | Independent Director | ||
Meng Mei(1) (2) (3) | 66 | Independent Director | ||
Shan Fu | 54 | Independent Director | ||
Nan Wang | 54 | Chief Financial Officer, Vice President | ||
Qiang Gao | 44 | Vice President, | ||
Jing Li | 47 | Vice President, Quality and Production |
(1) | Member of the audit committee. |
(2) | Member of the corporate governance and nominating committee. |
(3) | Member of the compensation committee. |
Mr. Weidong Yin has served as our chairman, president, chief executive officer and secretary since September 2003. He previously worked as a medical doctor in infectious disease at the China Center for Disease Control and Prevention, Tangshan City, Hebei province. Mr. Yin has been dedicated to hepatitis research for over 20 years and was instrumental in the development of Healive. In addition, Mr. Yin has been appointed as the principal investigator by the Chinese Ministry of Science and Technology for many key governmental R&D programs such as Inactivated Hepatitis A Vaccine R&D, Inactivated SARS Vaccine R&D and New Human Influenza Vaccine (H5N1) R&D. He is also the president of Zhongguancun Listed Companies Association. He obtained his MBA from the National University of Singapore.
Mr. Simon Anderson has served as an independent director of our company since July 2004. He is a member of our audit, compensation, and corporate governance and nominating committees. Mr. Anderson advises companies listed on North American stock exchanges and private businesses in the areas of regulatory compliance, exchange listings and financial operations. He is a member of the Chartered Professional Accountants of British Columbia, having qualified as a Chartered Accountant in 1986. Mr. Anderson serves as a director of IBC Advanced Alloys Corp., which manufactures and processes alloys at its U.S. plants.
Mr. Yuk Lam Lo has served as an independent director of our company since March 2006. Mr. Lo is a member of the audit, compensation and corporate governance and nominating committees. Currently Mr. Lo is serving as the ChairmanFounding President of the Advisory Council for Food Safety of the FoodHK BioMed Innotech Association and Health Bureau HKSAR, an Executive Committee Member of the Chinese Manufacturers’ Association of Hong Kong (CMA) and Chairman of the Education Committee of CMA. Mr. Lo is also the Honorary Founding Chairman of Hong Kong Bio-Organization.Biotechnology Organization. In the educational area, Mr. Lo has been elected as an Honorary Fellow of the Hong Kong University of Science and Technology. He is an Honorary Chairman of Hong Kong Food Safety Association, Adjunct Professor ofalso the Chinese University of Hong Kong and Honorary Professor of several universities in China. Mr. Lo was heavily involved in several committees of the HKSAR Government. He had been appointedPreviously he served as the Chairman of the Advisory Council for Food Safety of the Food and Health Bureau HKSAR, Director of the Hong Kong Applied R&D Fund Co. Ltd., Chairman of the Biotechnology Committee of the Hong Kong Industry & Technology Development Council, and Chairman of Biotechnology Projects Vetting Committee of the Innovation and Technology Fund, HKSAR. In Mainland China, Mr. Lo is a Membermember of Chinese People’s Political Consultative Conference in Jilin province, andProvince. He previously served as a Consultantconsultant of the Centre for Disease Control and Prevention of China. In the business sector, he is an Independent Director of Luye Pharma Group Limited (2186.HK), Chairman of GT Healthcare Capital Partners, and CSPC Pharmaceutical Group Limited (1093.HK).Partner & Investment Committee Member of Hangsen Investment Management Limited. In recognition of his leadership in the community and dedication to his field, Mr. Lo has received many awards, such as the “Pericles International Prize” in 2019. He is the second Asian and the first person from Hong Kong to be awarded the Prize since it was founded in 1986. In 2020, Mr. Lo was awarded the Bronze Bauhinia Star from the HKSAR government for his outstanding services over the past decades.
Mr. Kenneth Lee is an independent director of Sinovac. He has served on our board of directors since May 2011. In July 2012, the board appointed him as a member of the compensation committee and corporate governance and nominating committee. Mr. Lee is a partner at SAIF Partners. SAIF Partners IV L.P. is currently the largest shareholder of Sinovac. Mr. Lee has more than 20 years of experience across private equity investments, corporate finance, and business development in China. He is a non-executive director on the boardsboard of threeanother Chinese portfolio companies publiclycompany listed on the stock exchanges in the United States andStock Exchange of Hong Kong andKong. Mr. Lee was a board director for four other private Chinese companies backed bypartner at SAIF Partners. Mr. Lee is a graduate ofHe graduated from Amherst College.
Mr. Meng Meihas served as an independent director of our company since March 2012. Mr. Mei is the chairman of compensation committee, and member of the audit and corporate governance and nominating committees. Mr. Mei founded TusPark, a science park established by Tsinghua University in 1994, to incubate high growth companies. He has been the director of TusPark’s development center since its inception. Mr. Mei is also the Chairman of TusHoldings Co., Ltd., which is engaged in the development, construction, and management of TusPark and is providing services to enterprises based in TusPark. TusHoldings Co., Ltd. is also involved in venture capital investments in China. Mr. Mei sits on the judging expert panel of China’s National Science & Technology Award. He has developed courses on entrepreneurship and new venture formation as a Tsinghua University professor and an entrepreneur. Mr. Mei holds a bachelor’s degree in automation from Tsinghua University, PRC.
Mr. Shan Fu has served as an independent director since July 2018, when he was appointed as a director by the PIPE Investors in connection with the PIPE transaction described above. Mr. Fu is a Managing Partner at Vivo Capital. Vivo Capital is a healthcare focused investment firm formed in 1996 with over $3 billion under management. Prior to joining Vivo in 2013, Mr. Fu was Senior Managing Director in the Private Equity group and the Chief Representative of Blackstone’s Beijing Office. Additionally, Mr. Fu’s qualifications include experience in the Department of Foreign Investment in China’s National Development and Reform Commission, the State Economic and Trade Commission, the Office of Economic and Trade in State Council, and the Office of Production in State Council. Mr. Fu is currently a director on the boards of 4 biopharma companies, 1 medical consumable company, and 1 healthcare service company.
Ms. Nan Wang has served as our chief financial officer since June 2013. Ms. Wang served as the vice president of Sinovac Beijing from 2001 to 2013 where sheand the board director since 2009. Ms. Wang oversaw business development, investment and clinical research. From 1988 to 1993,Ms. Wang also served as the first general manager of Sinovac Dalian since establishment of this company. During her 19 years of service, Ms. Wang was responsible for our business development, investment and clinical research. She has been actively promoted our foreign cooperation, leading domestic and international cooperation negotiations on a researcher in biology atnumber of projects including equity, technology and market, and successfully achieving a number of foreign cooperation. Ms. Wang has led clinical research on many important projects including SARS vaccine (phase I), inactivated H5N1 influenza (avian flu) vaccine, influenza, H1N1 influenza vaccine and EV71 vaccine (Vero Cell), inactivated, and has actively promoted the Life Science Collegelisting of Peking University, PRC. From 1993 to 2001, she worked as a manager at SinoBioway.new products. Ms. Wang received her bachelor’s degree in biology from Peking University and her master’s degree from University of International Business and Economics, PRC. Ms. Wang also received a diploma in financial management from Beijing College for Entrepreneurs, PRC in 2003.
Ms. Xiaomei YinMr. Qiang Gao has served as our vice president since December 29, 2017. She is responsible for our oversee sales and marketing. Ms. Yin joined business development department of Sinovac Beijing in May 2006. She was appointed as director of government relations in February 2010. Before joined us, Ms. Yin worked with Industrial and Commercial Bank of China, one of the major commercial banks in China. She received a bachelor degree in finance from Central University of Finance and Economics, PRC.
Mr. Qiang Gao has served as our vice presidentchief operating officer since April 2016.2020. Mr. Gao joined Sinovac Beijing in 2002 and has served as quality control manager, quality assurance manager, R&D manager and R&D director at Sinovac Beijing in the past years, and the general manager of Sinovac R&DLS since 2010. He2010, and our vice president since April 2016. Mr. Gao has participated in the development of several vaccine varieties, including influenza vaccine, SARS vaccine, inactivated H5N1 influenza (avian flu) vaccine, EV71 vaccine, COVID-19 vaccine, ongoing sIPV vaccine and declared 23-valent pneumonia vaccine. Under his leadership, we successfully passed the WHO assessment and were selected to be eligible to import inactivated polio vaccine technology from the Netherlands and participate in the global polio eradication project. This project makes China become one of only six developing countries eligible for the technology transfer. Mr. Gao is responsible for developing our new vaccine products, including EV71 vaccine.currently a member of the Beijing Virus Society, Master of Engineering Supervisor of Institute of Microbiology (Chinese Academy of Sciences), and a subject review expert of the Beijing Municipal Science and Technology Commission. Mr. Gao received a master’s degree and a bachelor’s degree in microbiology from the University of Agriculture, PRC.
Ms. Jing Li has served as our vice president since April 2016. Ms. Li was named as quality person of Sinovac Beijing in March 2015. Since she joined Sinovac Beijing in 2003, she has worked in different roles in production and quality function, including quality assurance vice manager, department manager of hepatitis A vaccine production and director of vaccine production at Sinovac Beijing. Ms. Li is also in charge ofhas successively organized and completed the production and site inspection of our EV71 vaccine, the commercial production and application of 23-valent pneumococcal polysaccharide vaccine. As the project leader, she organized and led the effort to pass WHO pre-certification assessment of hepatitis A vaccine, which significantly promoted the export sales of hepatitis A vaccine. Ms. Li received a master’s degree in physiology from the University of Agriculture, PRC.
No family relationship exists among any of our directors or members of our executive officers named above and no arrangement or understanding exists between any of our major shareholders, customers, suppliers or others, pursuant to which any person referred to above was selected as a director or executive officers.
B. | Compensation |
In 2017,2020, the aggregate cash compensation paid to our directors and executive officers was approximately $2.80 million.$8.3million.
We have not set aside or accrued any amount of cash to provide pension, retirement or other similar benefits to our officers and directors. Our PRC subsidiaries and consolidated affiliated entities as well as their subsidiaries are required by law to make contributions equal to certain percentages of each employee’s salary for his or her retirement benefits, medical insurance benefits, housing funds, unemployment and other statutory benefits.
INDEMNIFICATION AGREEMENTS
Our companyWe have entered into indemnification agreements with each of our directors and executive officers. Under these agreements, we may agree to indemnify our directors and executive officers against certain liabilities and expenses incurred by such persons in connection with claims made by reason of their being a director or officer of our company.
EMPLOYMENT AGREEMENTS; NON-DISCLOSURE, NON-COMPETITION AND PROPRIETARY INFORMATION AGREEMENT
We have entered into employment agreements with each of our executive officers. Under these agreements, each of our executive officers is employed for a specified time period. We may terminate the employment of any director and officers for cause, at any time, without notice or remuneration, for certain acts of such director and officer, such as conviction of or plea of guilty to a felony or to an act of fraud, misappropriation or embezzlement, gross negligence or dishonest acts to our detriment, gross misconduct or a failure to perform agreed duties, death or disability (physical or mental impairment). Our companyWe may also terminate his or her employment without cause, at any time, upon a one month’s written notice. Our directors and officers may terminate their employment, at any time, with a one-month prior written notice to our company for good reason, including material diminution in their authority, duties, responsibilities or cash compensation as detailed in their employment agreements, or in event of any action or inaction that constitutes a material breach by our company under the employment agreement, in the manner set forth in their employment agreements. Upon termination of his or her employment with our companyus by our company without cause or by him or her for good reason, such director and executive officer is entitled to receive severance benefits including cash payment equal to the amount set forth in his or her employment agreement. In addition, all the share options and restricted share award granted to him or her under our stock/share incentive plans will become fully vested on the employment termination date and such share options will remain exercisable for eighteen months following the employment termination date.
In addition, each of our executive officer has entered into a non-disclosure, non-competition and proprietary information agreement and agreed to be bound by non-competition and non-solicitation restrictions during the term of his or her employment and typically for one year and four years, respectively, following the last date of employment.
The bonus plan of the executive officers is made based on our annual performance in different functions and the respective key result areas of these functional teams. Each vice president’s bonus is determined based on the key corporate development objectives and key performance index set by the compensation committee and approved by the board at the beginning of the year. The bonus payoff plan is approved by the board.
Our shareholders have authorized the board of directors to administer two share incentive plans which in aggregate provide for the issuance of up to 9,000,000 shares of common stock, including 5,000,000 shares reserved under the 2003 Stock Option Plan and 4,000,000 shares reserved under 2012 Share Incentive Plan. As of December 31, 2020, an aggregate of 42,800 shares, consisting 42,800 shares under the 2003 Stock Option Plan and no shares under the 2012 Share Incentive Plans, are still available for any future grant of incentive awards under the two share incentive plans. The following tables summarize, as of December 31, 2017,2020, the outstanding options and regular shares that we granted to several of our directors, executive officers, principal shareholders and to other individuals as a group, all of which were made under our 2012 Share Incentive Plan.
Name |
| Number of Options |
|
| Exercise Price($/Share) |
|
| Grant Date |
| Expiration Date | ||
Weidong Yin |
|
| 120,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Simon Anderson |
|
| 40,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Yuk Lam Lo |
|
| 40,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Meng Mei |
|
| 10,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Kenneth Lee |
|
| 40,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Nan Wang |
|
| 60,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Xiaomei Yin |
|
| — |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Qiang Gao |
|
| — |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Jing Li |
|
| — |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Others as a group |
|
| 70,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Subtotal |
|
| 380,000 |
|
|
| 4.98 |
|
| May 1, 2015 |
| April 30, 2023 |
Name |
| 2012 Share Incentive Plan | ||||||||||||||||||||
| Name | Restricted Shares | Number of Options | Exercise Price($/Share) | Grant Date | Expiration Date | Total | ||||||||||||||
| Weidong Yin | - | 150,000 | 4.98 | May 1, 2015 | April 30, 2023 | 150,000 | ||||||||||||||
| Simon Anderson | - | 40,000 | 4.98 | May 1, 2015 | April 30, 2023 | 40,000 | ||||||||||||||
| Yuk Lam Lo | - | 40,000 | 4.98 | May 1, 2015 | April 30, 2023 | 40,000 | ||||||||||||||
| Meng Mei | - | 40,000 | 4.98 | May 1, 2015 | April 30, 2023 | 40,000 | ||||||||||||||
| Kenneth Lee | - | 40,000 | 4.98 | May 1, 2015 | April 30, 2023 | 40,000 | ||||||||||||||
| Nan Wang | 22,500 | 90,000 | 4.98 | May 1, 2015 | April 30, 2023 | 112,500 | ||||||||||||||
| Ming Xia | 22,500 | 45,000 | 4.98 | May 1, 2015 | April 30, 2023 | 67,500 | ||||||||||||||
| Xiaomei Yin | 7,500 | 20,000 | 4.98 | May 1, 2015 | April 30, 2023 | 27,500 | ||||||||||||||
| Qiang Gao | 18,750 | 40,000 | 4.98 | May 1, 2015 | April 30, 2023 | 58,750 | ||||||||||||||
| Jing Li | 18,750 | 80,000 | 4.98 | May 1, 2015 | April 30, 2023 | 98,750 | ||||||||||||||
| Others as a group | 182,000 | 443,500 | 4.98 | May 1, 2015 | April 30, 2023 | 625,500 | ||||||||||||||
| Subtotal | 272,000 | 1,028,500 | 4.98 | May 1, 2015 | April 30, 2023 | 1,300,500 | ||||||||||||||
Restricted Shares | Grant Date | |||||
Weidong Yin | 160,000 | March 7, 2018 | ||||
Nan Wang | 160,000 | March 7, 2018 | ||||
Xiaomei Yin | 120,000 | March 7, 2018 | ||||
Qiang Gao | 120,000 | March 7, 2018 | ||||
Jing Li | 120,000 | March 7, 2018 | ||||
Others as a group | 1,283,000 | March 7, 2018 | ||||
Subtotal | 1,963,000 | March 7, 2018 | ||||
We have not set aside or accrued any amount of cash to provide pension, retirement or other similar benefits to our officers and directors. Our PRC subsidiaries and consolidated affiliated entities as well as their subsidiaries are required by law to make contributions equal to certain percentages of each employee’s salary for his or her retirement benefits, medical insurance benefits, housing funds, unemployment and other statutory benefits.
2003 STOCK OPTION PLAN
Our board of directors adopted the 2003 Stock Option Plan or the 2003 Plan,(the “2003 Plan”) on November 1, 2003. The purpose of the plan is to attract and retain the best available personnel for positions of substantial responsibility, provide additional incentive to employees, directors and consultants and promote the success of our business. Our board of directors believes that our company’s long-term success depends on our ability to attract and retain superior individuals who, by virtue of their ability, experience and qualifications, make important contributions to our business.
Set forth below is a summary of the principal terms of the 2003 Plan.
• | Size of plan.We have reserved an aggregate of 5,000,000 of our common shares for issuance under the 2003 Plan. As of December 31, |
• | Administration.The 2003 Plan is administered by our board of directors. The board will determine the provisions, terms and conditions of each option grant, including without limitation the option vesting schedule or exercise installment, the option exercise price, payment contingencies and satisfaction of any performance criteria. |
• | Vesting schedule. The vesting schedules of options granted will be specified in the applicable option agreements. |
• | Option agreement.Options granted under the 2003 Plan are evidenced by option agreements that contain, among other things, provisions concerning exercisability and forfeiture upon termination of employment or consulting arrangements by reason of death or otherwise, as determined by our board. In addition, the option agreement also provides no option shares will be issued under the plan unless the Securities Act has been fully complied with. |
• | Option term. The term of options granted under the 2003 Plan may not exceed ten years from the date of grant. |
• | Termination of options.Where the option agreement permits the exercise of the options granted for a certain period of time following the recipient’s termination of services with us, the options will terminate to the extent any options are not exercised or purchased on the last day of the specified period or the last day of the original term of the options, whichever occurs first. |
• | Change of control.If a third-party acquires us through the purchase of all or substantially all of our assets, a merger or other business combination, all outstanding stock options will become fully vested and exercisable immediately prior to such transaction. |
• | Termination of plans.Unless terminated earlier, the Plan will expire in 2023. Our board of directors has the authority to terminate the 2003 Plan prior to the expiry of the plan provided that such early termination shall not affect the options then outstanding under the plan. |
2012 SHARE INCENTIVE PLAN
In August 2012, our shareholders adopted a 2012 Share Incentive Plan, or the 2012 Plan. The maximum aggregate number of common shares which may be issued pursuant to all awards under the 2012 Plan is 4,000,000 shares. As of December 31, 2020, 3,073,700 common shares were issued under the 2012 Plan. The following paragraphs describe the principal terms of the 2012 Plan.
Types of Awards
The types of awards we may grant under the plan include the options to purchase our common shares at a specified price and in a specified period determined by our board. Under the 2012 Plan, we may also grant awards of our (1) restricted shares, (2) restricted share units, (3) dividend equivalents, (4) deferred shares, (5) share payments and (6) share appreciation rights under the terms and conditions determined by our board of directors.
Eligibility
We may grant awards to the directors, officers, advisors and employees of us and our wholly owned subsidiaries and any entity which may thereafter be established.
Plan Administration
Our board of directors will administer the 2012 Plan. The board will determine the terms and conditions of each grant, including but not limited to, the exercise, grant or purchase prices, any reload provision, any restrictions or limitations on the awards, vesting schedules, restrictions on the exercisability of the awards, any accelerations or waivers, and any provision related to non-competition and recapture of gain on the awards.
Award Agreement
Awards granted under the plan will be evidenced by an award agreement that will set forth the terms, conditions and limitations for each award. The award agreement should be signed by the employee and a director or an officer of us. Share awards may be evidenced by way of an issuance of certificates or book entries with appropriate legends. The certificates and book entry procedures may be subject to counsels’ advice, stop-transfer orders or other conditions or restrictions where the plan administrator deems necessary to comply with the required laws and regulations.
Vesting
The 2012 Plan provides that the administrator may set the period during which an option or a share appreciation right can be exercised and may determine that an option or a share appreciation right may not be exercised for a specified period after it is granted. Such vesting can be based on criteria selected by the administrator. At any time after the grant of an option or a share appreciation right, the administrator may, in its sole discretion and subject to the terms and conditions it determines, accelerate the period during which an option or a share appreciation right vests. No portion of an option or a share appreciation right exercisable at the termination of service of an option or a share appreciation right holder with our company or subsidiaries can become exercisable afterwards, unless otherwise provided by the administrator.
Exercise Price and Term of Awards
The exercise price per share of options granted under the 2012 Plan is determined by the plan administrator in the award agreement. The price may be fixed or variable related to the fair market value of our ordinary shares. The term of any option granted should not exceed ten years. However, in the case where our incentive option is granted to an individual who, at the date of grant, owns more than ten percent of the total voting power of all classes of our shares, the price granted shall not be less than 110% of the fair market value on the date of grant and the option is exercisable for no more than five years from the date of grant.
For common share awards granted under the 2012 Plan, namely (1) restricted shares, (2) restricted share units, (3) dividend equivalents, (4) deferred shares, and (5) share payments, the consideration shall not be less than the par value of the shares purchased. The terms of the share awards are set by the plan administrator in its sole discretion.
The exercise price of share appreciation right under the 2012 Plan is determined by the plan administrator and set forth in the award agreement which may be a fixed or variable price related to the fair market value of the shares. The term of the share appreciation right will not exceed ten years.
The approval of shareholders is required for downward adjustment of the exercise prices of options or share appreciation rights. A downward adjustment of the exercise prices of options or share appreciation rights means (i) lowering the exercise price of outstanding options or share appreciation rights, or (ii) cancelling outstanding options or share appreciation rights in exchange for cash, other awards, or options or share appreciation rights with an exercise price that is less than the exercise price of the original options or share appreciation rights.
Transfer Restrictions
The awards granted under the 2012 Plan may not be sold, pledged, assigned or transferred other than by will or the laws of descent and distribution or, subject to the consent of the plan administrator, as required under the applicable laws.
Amendments or Termination
The 2012 Plan provides that in the event of any changes affecting our common shares or our share price, the plan administrator can make proportional and equitable adjustments to reflect such changes. Upon or in anticipation of a corporate transaction, including acquisition, disposal of substantially all or all assets, reverse takeover, dissolution, the plan administrator should in its discretion provide for replacement or assumption of such award. In the event of other changes, the board of directors should in its discretion make adjustments in the number and class of shares subject to awards outstanding on the date of such change to prevent dilution or enlargement of rights. The 2012 Plan will expire and no further awards may be granted after the tenth anniversary of the date the plan was adopted.
C. | Board Practices |
Board of Directors
Our Articles of Incorporation prescribe that we should have a minimum of one and a maximum of 15 directors. Currently, our board of directors comprises fivesix board members, fourfive of whom are independent. A director is not required to hold any shares in the company by way of qualification. A director may vote with respect to any contract, proposed contract or arrangement in which he is materially interested provided that such director must disclose his interest in the contract or arrangement. There is no age limit requirement for directors. Under Antigua law, our directors have a duty of loyalty to act honestly, in good faith and with a view to our best interests. Our directors also have a duty to exercise the skill they actually possess and such care and diligence that a reasonably prudent person would exercise in comparable circumstances. In fulfilling their duty of care to us, our directors must ensure compliance with our Articles of Incorporation and By-laws, as amended and re-stated from time to time. A shareholder has the right to seek damages if a duty owed by our directors is breached.
The functions and powers of our board of directors include, among others:
• | convening shareholders’ annual general meetings and reporting its work to shareholders at such meetings; |
• | declaring dividends and distributions; |
• | appointing officers and determining the term of office of officers; |
• | exercising the borrowing powers of our company and mortgaging the property of our company; and |
• | approving the transfer of shares of our company, including the registering of such shares in our share register. |
As described above, on March 5, 2018, we announced the re-election of the members of our board of directors—Mr. Weidong Yin, Mr. Yuk Lam Lo, Mr. Simon Anderson, Mr. Kenneth Lee, and Mr. Meng Mei—at ourthe 2017 AGM held on February 6, 2018.AGM. We also announced that we had determined, after consultation with our Antigua legal counsel, that an alternative, pre-printed ballot not made available to all our shareholders and purportedly submitted at our 2017 AGM by the Shareholder Group was invalid. On March 13, 2018, 1Globe filed a complaint against our company in the Eastern Caribbean SupremeAntigua Court in the High Court of Justice, Antigua and Barbuda, to dispute the results of the election. See “Item 8. Financial Information — A. Consolidated Statements and Other Financial Information — Legal and Administrative Proceedings” for additional information.In July 2018, Mr. Shan Fu was appointed to our board of directors in connection with the PIPE transaction.
Terms of Directors and Executive Officers
Our officers are elected by and serve at the discretion of the board of directors. Our directors are not subject to a term of office and hold office until a successor is elected at the next annual shareholders’ meeting. A director will be removed from office automatically if, among other things, the director (i) becomes bankrupt or makes any arrangement or composition with his creditors or (ii) dies or is found by our company to be or becomes of unsound mind. None of our directors has a service contract with us or any of our subsidiaries providing for benefits upon termination of employment.
Committees of the Board of Directors
Our board of directors has established an audit committee, a compensation committee and a corporate governance and nominating committee.
Audit Committee
Our audit committee consists of Messrs. Simon Anderson, Yuk Lam Lo and Meng Mei, and is chaired by Simon Anderson, all of whom satisfy the “independence” requirements of Rule 5605 of the NASDAQ Listing Rules and Rule 10A-3 under the Securities Exchange Act of 1934. The audit committee oversees our accounting and financial reporting processes and the audits of the financial statements of our company. The audit committee is responsible for, among other things:
• | selecting our independent auditors and pre-approving all auditing and non-auditing services permitted to be performed by our independent auditors; |
• | reviewing with our independent auditors any audit problems or difficulties and management’s response; |
• | reviewing and approving all proposed related party transactions, as defined in Item 404 of Regulation S-K under the Securities Act; |
• | discussing the annual audited financial statements with management and our independent auditors; |
• | reviewing major issues as to the adequacy of our internal controls and any special audit steps adopted in light of material control deficiencies; |
• | annually reviewing and reassessing the adequacy of our audit committee charter; |
• | such other matters that are specifically delegated to our audit committee by our board of directors from time to time; |
• | meeting separately and periodically with management and our internal and independent auditors; and |
• | reporting regularly to the full board of directors. |
In 20172020, our audit committee held meetings or passed resolutions by unanimous written consent eightfive times.
Compensation Committee
Our compensation committee consists of Messrs. Meng Mei, Simon Anderson, Yuk Lam Lo, and Kenneth Lee, and is chaired by Mr. Meng Mei, all of whom satisfy the “independence” requirements of Rule 5605 of the NASDAQ Listing Rules and Rule 10C-1 under the Securities Exchange Act of 1934. Our compensation committee assists the board in reviewing and approving the compensation structure of our directors and executive officers, including all forms of compensation to be provided to our directors and executive officers. Members of the compensation committee are not prohibited from direct involvement in determining their own compensation. Our chief executive officer may not be present at any committee meeting during which his compensation is deliberated. The compensation committee is responsible for, among other things:
• | approving and overseeing the compensation package for our executive officers; |
• | reviewing and making recommendations to the board with respect to the compensation of our directors; |
• | reviewing and approving corporate goals and objectives relevant to the compensation of our chief executive officer, evaluating the performance of our chief executive officer in light of those goals and objectives, and setting the compensation level of our chief executive officer based on this evaluation; and |
• | reviewing periodically and making recommendations to the board regarding any long-term incentive compensation or equity plans, programs or similar arrangements, annual bonuses, employee pension and welfare benefit plans. |
In 2017,2020, our compensation committee held meetings or passed resolutions by unanimous written consent twice.three times.
Corporate Governance and Nominating Committee
Our corporate governance and nominating committee consists of Messrs. Yuk Lam Lo, Simon Anderson, Kenneth Lee and Meng Mei, and is chaired by Mr. Yuk Lam Lo, all of whom satisfy the “independence” requirements of Rule 5605 of the NASDAQ Listing Rules. The corporate governance and nominating committee assists the board of directors in identifying individuals qualified to become our directors and in determining the composition of the board and its committees. The corporate governance and nominating committee is responsible for, among other things:
• | identifying and recommending to the board nominees for election or re-election to the board, or for appointment to fill any vacancy; |
• | reviewing annually with the board the current composition of the board in light of the characteristics of independence, age, skills, experience and availability of service to us; |
• | identifying and recommending to the board the directors to serve as members of the board’s committees; |
• | advising the board periodically with respect to significant developments in the law and practice of corporate governance as well as our compliance with applicable laws and regulations and making recommendations to the board on all matters of corporate governance and on any corrective action to be taken; and |
• | monitoring compliance with our code of business conduct and ethics, including reviewing the adequacy and effectiveness of our procedures to ensure proper compliance. |
In 2017,2020, our corporate governance and nominating committee did not holdheld meetings or passed resolutions instead, the matters for discussion were combined to the meetings or resolutions by the board of directors.unanimous written consent three times.
Interested Transactions
A director may vote in respect of any contract or transaction in which he or she is interested, provided that the nature of the interest of any directors in such contract or transaction is disclosed by him or her at or prior to its consideration and any vote in that matter.
Remuneration and Borrowing
The directors may determine remuneration to be paid to the directors. The compensation committee assists the directors in reviewing and approving the compensation structure for the directors. The directors may exercise all our powers to borrow money and to mortgage or charge its undertaking, property and uncalled capital, and to issue debentures or other securities whether outright or as security for any debt obligations of our company or of any third party.
D. | Employees |
As of December 31, 2017, 20162020, 2019 and 2015,2018, we had 644, 7241,959, 910 and 646735 full-time employees, respectively. Of our workforce as of December 31, 2017,2020, about 98190 employees are primarily engaged in research and development, 6693 employees are engaged in sales and marketing, 4151,497 employees in production related and 65179 employees in administration. As of December 31, 2017,2020, we have a total of 156253 temporary employees. We consider our relationship with our employees to be good.
E. | Share Ownership |
The following table sets forth information with respect to the beneficial ownership of our common shares, as of DecemberMarch 31, 2017,2021, by:
• | each of our directors and executive officers; and |
• | each person/organization known to us to own beneficially more than 5% of our common shares. |
The calculations in the table below are based on 57,281,86171,517,402 common shares outstanding as of DecemberMarch 31, 2017.2021 before taking into account the issuance of the Exchange Shares in the Exchange and 113,925,556 shares, including 99,294,743 common shares and 14,630,813 Series B Preferred Shares, after taking into account the issuance of the Exchange Shares in the Exchange. Beneficial ownership is determined in accordance with the rules and regulations of the SEC. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, we have included shares that the person has the right to acquire within 60 days, including through the exercise of any option, warrant or other right or the conversion of any other security. These shares, however, are not included in the computation of the percentage ownership of any other person. Additionally, for purposes of this item, share counts and calculations in the table below do not reflect the issuance of the Exchange Shares into the Shareholder 2019 Rights Exchange Trust in connection with the Exchange.
| Shares Beneficially Owned |
| before issuance of the Exchange Shares |
| after issuance of the Exchange Shares |
| ||||||||||||
| Number | % |
| Number |
| % |
| Number |
| % |
| |||||||
| Directors and Executive Officers: |
|
|
|
|
|
|
|
|
| ||||||||
| Weidong Yin | 6,124,500 | 10.56 | % |
| 6,359,500 |
| 8.89 |
| 12,569,000 |
| 11.03 |
| |||||
| Simon Anderson | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Yuk Lam Lo | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Meng Mei | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Kenneth Lee | * | * |
| * |
| * |
| * |
| * |
| ||||||
Shan Fu |
| — |
| — |
| — |
| — |
| ||||||||
| Nan Wang | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Ming Xia | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Xiaomei Yin | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Qiang Gao | * | * |
| * |
| * |
| * |
| * |
| ||||||
| Jing Li | * | * |
| * |
| * |
| * |
| * |
| ||||||
| All directors and executive officers as a group | 6,824,847 | 11.54 | % |
| 7,536,847 |
| 10.54 |
| 14,599,714 |
| 12.82 |
| |||||
| Principal Shareholders |
|
|
|
|
|
|
|
|
| ||||||||
| SAIF Partners IV(1) | 10,780,820 | 18.82 | % |
| 10,780,820 |
| 15.07% |
| 21,561,640 |
| 18.93% |
| |||||
| 1Globe Capital LLC(2) | 9,353,092 | 16.33 | % | ||||||||||||||
| Chiang Li Family(3) | 3,459,763 | 6.04 | % | ||||||||||||||
| Samuel D. Isaly(4) | 2,667,500 | 4.66 | % | ||||||||||||||
Prime Success, L.P.(2) |
| 5,900,000 |
| 8.25% |
| 11,800,000 |
| 10.36% |
| ||||||||
Vivo Capital(3) |
| 5,900,000 |
| 8.25% |
| 11,800,000 |
| 10.36% |
| ||||||||
CDH Utopia Limited(4) |
| 6,000,000 |
| 8.39% |
| 6,000,000 |
| 5.27% |
| ||||||||
1Globe Capital LLC(5) |
| 3,353,092 |
| 4.69% |
| 3,353,092 |
| 2.94% |
| ||||||||
Total share outstanding |
| 71,517,402 |
| 100.00% |
| 113,925,556 |
| 100.00% |
| ||||||||
* |
| Less than 1% of our common shares. |
(1) | According to the Amendment No. 6 to Schedule 13D filed with the SEC on June 27, 2017 by SAIF Partners IV L.P., SAIF IV GP, L.P. and SAIF IV GP Capital Ltd. |
(2) | According to the Schedule 13G filed with the SEC on July 10, 2018 by Prime Success, L.P., Green Vision Partners Limited and Advantech Capital Partners Ltd. |
(3) | According to the Amendment No. 2 to Schedule 13D filed with the SEC on August 27, 2018 by Vivo Capital, LLC, Vivo Capital VIII, LLC and Vivo Capital IX, LLC. |
(4) | According to the Schedule 13D filed with the SEC on December 22, 2020 by CDH Utopia Limited, CDH Fund VI, L.P., CDH VI Holdings Company Limited and CDH Griffin Holdings Company Limited. |
(5) | According to the Schedule 13D filed with the SEC on July 7, 2017, |
None of our existing shareholders has different voting rights from other shareholders. Holders of our Series B Preferred Shares vote together with the common shares on an as-converted basis on all matters presented to the shareholders for a vote, subject to applicable law. Except for the proposed going private transaction as disclosed in “Item 4. Information on the Company — History and Development of the Company” or elsewhere in this annual report and the complaint against filed by 1Globe against the CompanySinovac Antigua in the Eastern Caribbean Supreme Court in the High Court of Justice, Antigua and Barbuda, or the Antigua Court, as disclosed in “Item 8. Financial Information — A. Consolidated Statements and Other Financial Information — Legal and Administrative Proceedings” or elsewhere in this annual report, we are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company.
As of December 31, 2017, 57,281,8612018, 71,139,402 of our common shares were issued and outstanding. Approximately 88%On February 22, 2019, 27,777,341 of Sinovac Antigua’s common shares and 14,630,813 of Sinovac Antigua’s Series B preferred shares were issued into the Shareholder 2019 Rights Exchange Trust in connection with the Exchange. As described below under “Item 8. Financial Information — A. Consolidated Statements and Other Financial Information — Legal and Administrative Proceedings”, courts in Antigua and Delaware have enjoined the Company from issuing Exchange Shares from the Trust until final resolution of such matters. Taking into account issuance of the Exchange Shares, immediately following such issuance, 98,918,243 of common shares and 14,630,813 of Series B Preferred Shares were issued and outstanding. As of December 31, 2020, 99,294,743 of common shares and 14,630,813 of Series B Preferred Shares were issued and outstanding. Approximately 89% of the aggregate total of common shares and Series B Preferred Shares issued and outstanding shares were held by the record shareholders in the United States.
To our knowledge, except as disclosed elsewhere in this annual report, we are not directly or indirectly owned or controlled by another corporation, any foreign government or any other natural or legal person, severally or jointly.
For the options granted to our directors, officers and employees, please refer to “— B. Compensation.”
A. | Major Shareholders |
Please refer to “Item 6. Directors, Senior Management and Employees — E. Share Ownership.”
B. | Related Party Transactions |
Privatization
On June 26, 2017, we entered into the Amalgamation Agreement with Sinovac (Cayman) Limited, or Parent, and Sinovac Amalgamation Sub Limited, or Amalgamation Sub, a wholly owned subsidiary of Parent. Pursuant to the Amalgamation Agreement, Parent will acquire Sinovac Biotech Ltd. for cash consideration equal to $7.00 per common share. Immediately following the consummation of the transactions contemplated by the Amalgamation Agreement, Parent will be beneficially owned by a consortium, or the Buyer Consortium, comprising Mr. Weidong Yin, the chairman, president and chief executive officer of Sinovac Biotech Ltd., SAIF, C-Bridge Healthcare Fund II, L.P., Advantech Capital L.P., Vivo Capital Fund VIII, L.P. and Vivo Capital Surplus Fund VIII, L.P. 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 Sinovac Biotech Ltd., with Sinovac Biotech Ltd. continuing as the surviving corporation and a wholly owned subsidiary of Parent, or the Amalgamation.
Our board of directors, acting upon the unanimous recommendation of the Special Committee, unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that our shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.
The Amalgamation is subject to customary closing conditions, including approval by an affirmative vote of holders of Shares representing at least two-thirds of our common shares present and voting in person or by proxy as a single class at a meeting of our 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. If completed, the Amalgamation will result in Sinovac Biotech Ltd. becoming a privately-held company and our common shares will no longer be listed on NASDAQ.
On March 26, 2018, we amended the Amalgamation Agreement to extend its termination date to April 26, 2018. On April 26, 2018, we further amended the Amalgamation Agreement to extend its termination date to May 26, 2018.
Transaction with Yuk Lam Lo
Sinovac Hong Kong is using part of the office of Mr. Yuk Lam Lo, one of our independent directors, as its office. We do not pay any rent to Mr. YukLo and only pay our share of the utilities and property management fees, which totaled $4,000, $7,000$3,998, $10,267 and nil in 2015, 20162020, 2019 and 2017,2018, respectively.
Transactions with Certain Directors and Affiliates
We entered into two operating lease agreements with SinoBioway, the parent company of Sinobioway Medicine which is the non-controlling shareholder of Sinovac Beijing, in 2004,with respect to lease Sinovac Beijing’s production plant and laboratory in Beijing, China with annual lease payments totaling RMB2.3RMB 1.4 million ($0.40.2 million). The leases commenced on August 12, 2004 and have a term of 20 years. One of the lease agreements was amended on August 12, 2010 to increasewith the rent increasing from RMB0.5RMB 0.5 million ($75,000)76,628) to RMB1.4RMB 1.4 million ($0.2 million) per year.
In June 2007, we entered into another operating lease agreement with SinoBioway, with respect to the expansion of Sinovac Beijing’s production plant in Beijing, China, for an annual lease payment of RMB2.0 million ($0.3 million) to expand Sinovac Beijing’s production plant in Beijing.. The lease commenced in June 2007 and has a term of 20 years.
In September 2010, we entered into another operating lease agreement with SinoBioway with respect to expansion of Sinovac LS’ business in research and development activities for an annual lease payment of RMB1.0RMB 1.0 million ($0.20.1 million) to expand Sinovac R&D’s business.. The lease commenced on September 30, 2010 and has aan initial term of five years.
On April 8, 2013, we entered into threefour supplemental agreements with SinoBioway, under which the expiration date of three of theall operating lease agreements was extended to April 7, 2033.
In 2019, we entered into an operating lease agreement with Dalian Jin Gang Group, the non-controlling shareholder of Sinovac Dalian, to rent refrigeration storage with the space of 2,000 sq.m. with an annual rent amounted RMB0.3 million ($49,000). The lease commenced on January 1, 2019 and had a term of five years. On June 30, 2019, the lease agreement was amended. The term of the lease was changed to from July 1, 2019 to December 31, 2024, and the annual rent was changed to RMB0.2 million ($22,000) as the space of the leased refrigeration storage was reduced to 1,000 sq.m. In 2019, we also entered into a management service agreement with Dalian Jin Gang Group, pursuant to which it provided us with management service related to the operating lease agreement with an annual management service fee of RMB100,000 ($14,000). The management service agreement was amended on June 30, 2019, and the annual management service fee was changed to RMB44,000 ($6,000).
Loan from a non-controlling shareholder
In 2011, Sinovac Dalian entered into an agreementWe have four loans due to borrow RMB20.0 million ($3.1 million) loan from its non-controlling shareholder, Dalian Jin Gang Group. The loanGroup, the non-controlling shareholder of Sinovac Dalian, with a total amount of RMB 80 million ($12.3 million), of which two loans totalling RMB 40 million ($6.1 million) were borrowed in August 2020 and are repayable on August 18, 2021. RMB 10 million ($1.5 million) was borrowed in September 2019 and is repayable on September 19, 2022. RMB 30 million ($4.6 million) was borrowed in August 2020 and is repayable on August 9, 2023. These four loans are unsecured, bearing interest at 7.2%6.5% per year. RMB4.0 million ($0.6 million) was repaid on September 25, 2014. No repayments were made in 2017year and 2016, respectively. In 2017, Sinovac Dalian entered into an agreement to borrow RMB30.0 million ($4.6 million) loan from its non-controlling shareholder, Dalian Jin Gang Group. The loan was unsecured, bearing interest at 6.0% per year. No repayments were made in 2017.
payable monthly.
Share Options
See “Item 6. Directors, Senior Management and Employees — B. Compensation — 2003 Stock Option Plan” and “Item 6. Directors, Senior Management and Employees — B. Compensation — 2012 Share Incentive Plan.”
Indemnification Agreements
“Item 6. Directors, Senior Management and Employees — B. Compensation — Indemnification Agreements.”
Employment Agreements; Non-Disclosure, Non-Competition and Proprietary Information Agreement
“Item 6. Directors, Senior Management and Employees — B. Compensation — Employment Agreements; Non-Disclosure, Non-Competition and Proprietary Information Agreement.”
C. | Interests of Experts and Counsel |
Not applicable.
A. | Consolidated Statements and Other Financial Information |
We have appended consolidated financial statements filed as part of this annual report.
Legal and Administrative Proceedings
We may be subject to legal proceedings, investigations and claims relating to the conduct of our business from time to time.
DOJ and SEC Investigations and NASDAQ Inquiry
The Beijing People’s Court issued five judgementsjudgments in 2016 and 2017. These judgments were related to corrupt conduct allegedly engaged in by a former official of the Center for Drug Evaluation in CFDA,NMPA, his wife and his son. These judgments found that the official and his wife had engaged in a practice of improperly soliciting and accepting payments from various individuals involved in the vaccine products industry. According to the judgments, one of the individuals solicited by the official was Mr. Weidong Yin, our chairman, president and chief executive officer. It was asserted in the judgments that Mr. Weidong Yin made three payments, and arranged for a loan, to the official and his wife, in the total amount of RMB550,000 ($77,000) between 2002 and 2011. Mr. Weidong Yin was not charged with any offense or improper conduct and he cooperated as a witness with the procuratorate. To our knowledge, the Chinese authorities have not commenced any legal proceedings or government inquiries against Mr. Yin. In December 2016, our audit committee authorized the commencement of an internal investigation into the allegations made in the judgements.judgments. The audit committee engaged Latham & Watkins LLP as independent counsel to assist with the investigation.
In 2017 and 2018, we 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”).CDC. While these judgments appear to reflect an industry-wide investigation focused on CDC officials, they also referenced nine of the Company’sour former salespersons, together with sales personnel from several other Chinese vaccine companies and distributors. These judgments did not name, and no charges were brought against, the Companyour company or any of itsour directors or officers as defendants. To the best of our knowledge, the nine referenced employees cooperated with the procuratorate. The procuratorate did not contact the Companyus for cooperation. Upon becoming aware of these judgments, our Audit Committee expanded its internal investigation to review matters related to these judgments and the Company’sour sales practices and policies, and further engaged Latham & Watkins LLP to continue the independent investigation with the expanded scope. Recently, the Company became aware that oneOne of the nine former sales employees has been convicted for giving bribes. The judgment states that this former sales employee took these actions without knowledge of the Company.our company. His criminal penalty was waived by the court. The Company has become aware that another one of the nine former sales employees might also be investigated by the procuratorate.
After we publicly announced the internal investigation arising from the allegations in a research report in December 2016, we were notified by the SEC in February 2017 of an enforcement inquiry related to the matters discussed in the report, and in April 2017 we received a subpoena from the SEC requesting documents. In September 2017, we received an inquiry from the Department of Justice (the “DOJ”)DOJ and we have been cooperating with the DOJ. The SEC and DOJ have requested information regarding the judgments discussed above, and we are cooperatingcooperated with these requests.
Also in February 2017, we received an inquiry from NASDAQ related to the same matter. Further, in May 2018, we received an inquiry from NASDAQ requesting information related to the actions by Sinobioway Medicine and their impact on our operations and financial reporting. We have cooperated with both of these NASDAQ inquiries.
We take these matters very seriouslyOn August 14, 2018, the SEC notified us that the SEC had concluded its investigation and are committed to conducting business in compliance with all applicable laws. However,would not recommend an enforcement action against us at this time,time. On September 12, 2018, the DOJ notified us that it had closed its investigation, with no charges. With the closure of the DOJ’s investigation, we are unable to predict, what, ifnot aware of any action may be taken by NASDAQ, the SEC and the DOJ or any penalties or remedial measures these agencies may seek, but intend to continue to cooperate with these agencies. Any determination that our operations or activities are not in compliance with existing laws or regulations could result in the impositionpending U.S. government investigations of fines, civil and criminal penalties, and equitable remedies, including disgorgement or injunctive relief. We cannot determine as to whether an ultimate unfavorable outcome is either probably or remote, nor reasonably estimate the amount or range of the potential liability, if any,us related to these matters resulting from any proceedings that may be commenced by the SEC or any other governmental authorities.matters.
US Litigation
On July 3, 2017, a securities class action complaint was filed in the U.S. DistrictDelaware Chancery 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. On September 6, 2017, the plaintiff has filed the notice of voluntary dismissal. The Court granted the dismissal without prejudice.
On July 12, 2017, an alleged shareholder of the Company filed a putative class action complaint in the Supreme Court of the State of New York against the Company, its directors, and certain entities related to the Amalgamation. The complaint alleges that the Company’s directors breached their fiduciary duties by, among other things, entering into a self-dealing transaction at a price below fair value and failing to take steps to maximize the value of the Company. The complaint also alleges that the Company aided and abetted those alleged breaches of fiduciary duty. The complaint seeks, among other things, an injunction preventing completion of the Amalgamation, rescission of the Amalgamation to the extent it is implemented, damages, and attorneys’ fees. The Company is vigorously defending this lawsuit; however, the Company cannot determine as to whether an ultimate unfavorable outcome is either probably or remote, nor reasonably estimate the amount or range of the potential liability for this case at this stage.
Action
On March 5, 2018, the Companywe filed a lawsuit in the Court of Chancery of the State of Delaware seeking a determination whether 1Globe, The Chiang Li Family, OrbiMed and other shareholders of the CompanySinovac Biotech Ltd. had triggered ourthe Rights PlanAgreement by forming a group holding approximately 45% of the Company’s outstanding shares of Sinovac Biotech Ltd., in excess of the plan'splan’s threshold of 15%, and acting in concert prior to the 2017 AGM. OurThe Rights PlanAgreement is intended to promote the fair and equal treatment of all Sinovac shareholders and ensure that no person or group can gain control of Sinovac through undisclosed voting arrangements, open market accumulation or other tactics potentially disadvantaging the interest of all shareholders.
On April 12, 2018, 1Globe filed an amended answer to the Company’sSinovac Antigua’s complaint, counterclaims, and a third-party complaint against Mr. Weidong Yin alleging, among other allegations, that ourthe Rights PlanAgreement is not valid, that Mr. Weidong Yin and the Buyer Consortium had previously triggered ourthe Rights Plan,Agreement, and that 1Globe did not trigger ourthe Rights Plan. The CompanyAgreement. Sinovac Antigua and its board of directors believes that the actions taken by the board of directors were appropriate under the circumstances and that the allegations of the counterclaimcounterclaims and third-party complaint are without merit. 1Globe asks for various measures of equitable relief and also includes a claim for its costs, including attorneys’ fees. This litigation is currently
On July 31, 2018, following Sinovac Antigua motions for partial summary judgment and an expedited trial date, the Delaware Chancery Court effectively stayed the action pending receipt of a post-trial decision from the Antigua Court in the pre-trial phase withmatter captioned 1Globe Capital, LLC and Sinovac Biotech Ltd., Claim No. ANUHCV 2018/0120. On December 19, 2018, the Antigua Court issued a decision expected beforejudgment affirming the endvalidity of Sinovac Antigua’s Rights Agreement under Antigua law, and finding that “there was a secret plan to take control” of Sinovac Antigua at the 2017 AGM.
Based upon the Antigua Court’s judgment and other facts known to the board of directors, our board of directors determined that the Collaborating Shareholders became Acquiring Persons on or prior to the 2017 AGM and their conduct resulted in a Trigger Event under Sinovac Antigua’s Rights Agreement. As a result of becoming Acquiring Persons, the approximately 28.7 million Rights held by the Collaborating Shareholders automatically became void under the terms of the Rights Agreement. Pursuant to the Rights Agreement, our board of directors elected to exchange the approximately 42.4 million valid and outstanding Rights held by Sinovac Antigua’s shareholders (not including 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 Antigua issued into a trust on February 22, 2019 for the benefit of the holders of the valid and outstanding Rights. See “History and Development of the Company” for additional information.
On March 6, 2019, the Delaware Chancery Court entered a status quo order providing that Sinovac Antigua not distribute any of the Exchange Shares to rights holders until the final disposition of the pending Delaware litigation or further order of the Court. On April 4, 2019, the Eastern Caribbean Supreme Court, Court of Appeal issued an order that restrains Sinovac Antigua from taking further action under its Rights Agreement, including the distribution of the previously issued Exchange Shares to the holders of valid Rights, until the conclusion of 1Globe Capital, LLC’s appeal of the December 19, 2018 subject to appeal. The CompanyJudgment of the Antigua Court. On April 8, 2019, the Delaware Chancery Court stayed the Delaware litigation pending the outcome of 1Globe’s appeal of the Antigua Judgment. We cannot predict whether an ultimate outcome will be favorable or unfavorable, nor estimate the amount or range of potential loss (if any) at this time.
Massachusetts District Court Actions
On March 5, 2018, the CompanySinovac Antigua also filed a lawsuit in the United States District Court for Massachusetts alleging violations of Section 13(d) of the Securities Exchange Act of 1934 by 1Globe and The Chiang Li Family. The lawsuit alleges, among other things, that the defendant shareholders failed to make required disclosures on Schedule 13D regarding their intentions to attempt to replace the Company'sSinovac Antigua’s board of directors. The Company is vigorously pursuing this lawsuit; however, the Company cannot predict whether an ultimate outcome will be favorable or unfavorable, nor estimate the amount or range of potential loss (if any) at this time.
On April 9, 2018, the Companywe received a document request from the SEC requesting all of the Company’sour documents concerning 1Globe, the Chiang Li Family, OrbiMed, certain other shareholders, and their affiliates. We have been cooperating with the SEC. We understand the SEC is investigating whether 1Globe, and possibly other shareholders, violated the U.S. securities laws. We do not have any information to suggest the SEC is investigating the actions of the CompanySinovac Antigua or its officers and directors.
On May 21, 2018, 1Globe answered and filed counterclaims against Sinovac Antigua and certain of its executives, alleging violations of Section 10(b) of the Exchange Act and various state law claims. In response to Sinovac Antigua motion to dismiss 1Globe’s counterclaims, on August 1, 2018, 1Globe filed amended counterclaims against Sinovac Antigua and certain of its executives, alleging violations of Section 10(b) of the Exchange Act and Rule 10b-5, as well as state law claims of abuse of process, fraudulent misrepresentation, negligent misrepresentation, and aiding and abetting such violations, primarily arising out of allegedly false and/or misleading statements made by us regarding our business, operational, and financial results.
On August 17, 2018, the Massachusetts Court granted a consent motion to extend the deadline for Sinovac Antigua’s response to 1Globe’s counterclaims (and for any subsequent opposition by 1Globe) until after the Antigua Court issued a ruling in the matter captioned 1Globe Capital, LLC and Sinovac Biotech Ltd., Claim No. ANUHCV 2018/0120. On December 19, 2018, the Antigua Court issued a judgment, which 1Globe appealed on January 29, 2019. Per the Massachusetts Court’s order, the parties have filed periodic status reports regarding the pending court proceedings in Antigua. No date for Sinovac Antigua’s response to 1Globe’s counterclaims has been set. We are vigorously pursuing this lawsuit; however, we cannot predict whether an ultimate outcome will be favorable or unfavorable, nor estimate the amount or range of potential loss (if any) at this time.
Also on August 1, 2018, 1Globe filed a motion for preliminary injunction seeking to enjoin Sinovac Antigua from, inter alia, altering its capital structure. On October 15, 2018, the Massachusetts Court denied 1Globe’s motion. On November 14, 2018, 1Globe filed an appeal of the denial of its motion for preliminary injunction to the United States Court of Appeals for the First Circuit. On January 10, 2019, 1Globe filed a motion to hold its appeal in abeyance pending the outcome of its separate appeal of the Antigua Court’s judgment, which Sinovac Antigua opposed. In October 2019, 1Globe voluntarily dismissed the appeal.
Separately, Heng Ren Investments LP (“Heng Ren”) filed suit against Sinovac Antigua and Weidong Yin for alleged breach of fiduciary duties and wrongful equity dilution on May 31, 2019, in Massachusetts state court. Sinovac Antigua removed the matter from state court to the United States District Court for the District of Massachusetts. Heng Ren alleged that Mr. Yin breached fiduciary duties owed to minority shareholders, that Sinovac Antigua aided and abetted breaches of fiduciary duties, and that both Sinovac Antigua and Mr. Yin engaged in wrongful equity dilution. Heng Ren requested damages, attorneys’ fees, and prejudgment interest. On September 14, 2020, Sinovac Antigua filed a motion to dismiss Heng Ren’s claims and the court’s decision on that motion is pending as of the date of this annual report.
Antigua Litigation
On March 13, 2018, 1Globe filed a complaint against the CompanySinovac Antigua in the Eastern Caribbean Supreme Court in the High Court of Justice, Antigua and Barbuda, or the Antigua Court. The complaint seeks a declaration that the five persons purportedly proposed on the Non-Public Submission at the 2017 AGM were elected as directors of the CompanySinovac Antigua at that meeting, an order of the Antigua Court that those directors be installed as the Company’sSinovac Antigua’s board of directors, and a declaration that any actions taken on behalf of the CompanySinovac Antigua at the direction of the board of directors since the 2017 AGM are null and void. On April 10, 2018, 1Globe filed a notice of application in the Antigua Court seeking an order declaring the result of the disputed election, an urgent order restraining the Company’sSinovac Antigua’s board of directors from acting, pending determination of the dispute, including acting to initiate or continue litigation against the Shareholder Group, and other related relief. The CompanyWe attended the first hearing on May 9, 2018. In July 2018, the Antigua court heard an application by 1Globe for interim injunctive relief preventing Sinovac Antigua from exercising its rights under the Rights Agreement. This application was unsuccessful, but the judge set an expedited timetable to trial. The trial of the matter took place from December 3 to 5, 2018. On December 19, 2018, the judge handed down his judgment, finding in Sinovac Antigua’s favor in full, dismissing 1Globe’s claim and there will be further hearings declaring that the Rights Agreement was validly adopted as a matter of Antigua law. On January 29, 2019, 1Globe filed a Notice of Appeal. On March 4, 2019, 1Globe filed an application for urgent interim relief, seeking an injunction to prevent Sinovac Antigua from continuing to implement its Rights Agreement until the resolution of the appeal. This urgent interim relief application was heard on April 4, 2019,at which the Company will continueCourt of Appeal made an order restraining Sinovac Antigua in similar terms to vigorously defend the litigation; however,Delaware Court order of March 6, 2019, together with restraint from operating the CompanyRights Agreement in any way that affects 1Globe’s rights or shareholding until determination of the appeal. 1Globe’s appeal of the Antigua Court’s Judgment was heard on September 18, 2019, and the appeal decision is pending as of the date of this annual report. We cannot predict or estimate an outcome or economic burden for this case at this time.
Hong Kong Litigation
On April 4,October 8, 2018, Sinovac became aware that unauthorized documents in respect of Sinovac Hong Kong had been unlawfully filed with the Hong Kong Companies Registry to change the directors of Sinovac Hong Kong from Mr. Weidong Yin and Ms. Nan Wang to Mr. Jianzeng Cao and Mr. Pengfei Li. On October 15, 2018, Mr. Yin and Ms. Nan Wang commenced proceedings HCMP 1731/2018 before the Hong Kong High Court.
In a hearing before the Hong Kong High Court on October 19 2018, the Lawful Directors asked the court to grant an urgent interim injunction order to restrain Mr. Li and Mr. Cao from taking further unlawful actions against Sinovac HK and its subsidiaries. At the hearing, the judge granted an interlocutory injunction in the same terms sought by the Lawful Directors restraining Mr. Pengfei Li and Mr. Jianzeng Cao from purporting to act or holding themselves out as directors of Sinovac Hong Kong or its subsidiaries, purporting to take any actions as directors of Sinovac Hong Kong or its subsidiaries, and relying on or using the forged documents in any way whatsoever.
On November 28, 2018 at a further hearing in the Hong Kong High Court, the Hong Kong High Court made the November 28 Order and held that it is beyond dispute that the documents in respect of Sinovac Hong Kong 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 and Ms. Wang were and still are the lawful directors of Sinovac Hong Kong, and Mr. Li and Mr. Cao were not and are not the lawful directors of Sinovac Hong Kong. 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 Hong Kong or its subsidiaries (including but not limited to Sinovac Beijing), purporting to take any actions as directors of Sinovac Hong Kong 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 Hong Kong that had been unlawfully filed.
On November 28, 2018, Mr. Cao and Mr. Li filed a Notice of Appeal with the Hong Kong Court of Appeal, indicating their intention to appeal the orders made by the Hong Kong High Court. No hearing date has yet been fixed to hear the appeal. Mr. Yin and Ms. Wang intends to vigorously contest the appeal filed by Mr. Cao and Mr. Li. Pending the determination of the appeal, the November 28 Order remains effective and enforceable. Pursuant to the November 28 Order, the Hong Kong Companies Registry has removed the purported Sinovac Hong Kong documents from the Companies Register and updated Sinovac Hong Kong’s register of director such that the directors on record are Mr. Yin, Ms. Wang and Mr. Yuk Lam Lo.
As of the date of this annual report, neither the Court of First Instance nor the Court of Appeal directed that the execution of the November 28 Order should be stayed. So far, Mr. Cao and Mr. Li have taken no further steps in respect of the appeal after the Notice of Appeal was filed on November 28, 2018.
PRC Litigation
On May 16, 2018, Sinovac Hong Kong filed a complaint against Sinobioway Medicine, Mr. Aihua Pan, and Shandong Sinobioway Biomedicine Co., Ltd. in the Fourth Intermediate People’s Court of Beijing (“Beijing Fourth Court”). The complaint sought to hold the defendants jointly and severally liable for the torts they committed during an attempt of the defendants to take physical control of our facility in Shangdi site in Beijing on April 17, 2018. Later, Sinovac Hong Kong made an application to the court to add Sinovac Beijing as a third party to participate in the proceedings. The court has granted an order, permitting Sinovac Beijing to participate in the proceedings as a third party. At the hearing held on July 2, 2019, Sinovac Hong Kong, the defendants and Sinovac Beijing cross-examined the evidences submitted by each party. Based on the result of the cross-examination, the court declared that an independent evaluation firm shall be engaged by both the defendants and Sinovac Hong Kong to evaluate the losses and damages sustained by Sinovac Beijing as the result of the actions taken by the defendants on April 17, 2019. An independent evaluation firm was selected by the court and the evaluation was conducted accordingly. On September 17, 2020, the Fourth Intermediate People’s Court of Beijing issued a judgment holding Sinobioway Medicine and Mr. Aihua Pan liable for torts and breaches of shareholders fiduciary duty under the PRC Company Law and liable for Sinovac Beijing’s losses of RMB 15.4 million caused by their disruptive actions. Sinovac Beijing, Sinobioway Medicine and Mr. Aihua Pan filed notice to appeal to the Higher People’s Court of Beijing Municipality.
On September 13, 2018, Sinovac Beijing filed a complaint against Mr. Aihua Pan in the Haidian District Court of Beijing.Beijing (the “Haidian Court”). The complaint seekssought to request Mr. Pan return a declaration that the board resolutions dated February 6, 2018 purporting to appoint Mr. Aihua Pan as the general managerbusiness license of Sinovac Beijing which was reissued by the Haidian Branch of Beijing Administration for Industry and Commerce on May 10, 2018 based on the false reporting made by Mr. Pan and the seals of Sinovac Beijing which are invalid. forged by Mr. Pan. Sinovac Beijing filed a preservation application to the court. The court supported Sinovac Beijing’s preservation application and prohibited Mr. Pan from using or authorizing others to use the above-mentioned license and seals during the case hearing. The court held a preliminary and brief hearing on November 18, 2019. At the hearing, the court has decided and declared to suspend the proceedings until the final verdict of the September 5 Board Resolution Case (as described below) is given by the Beijing Fourth Court. As of the date of this annual report, the case is still pending.
On May 9,October 8, 2018, Sinovac also became aware that unauthorized documents in respect of Sinovac Beijing had been filed with the Industry and Commerce Bureau of Haidian District of Beijing (“Haidian AIC”) to change the directors of Sinovac Beijing from Mr. Weidong Yin, Ms. Nan Wang and Mr. Dawei Mao to Mr. Jianzeng Cao, Mr. Pengfei Li and Ms. Xiaomin Yang. Mr. Yin and Ms. Wang filed an objection to such unlawful change with the Haidian AIC. On March 19, 2020, Haidian AIC issued an official decision (“AIC Decision”) declaring that (i) the unauthorized documents are forged and fake documents; (ii) the filing of change of directors made based on the forged documents is null and void; (iii) the unlawful filing to change the said directors will be removed and (iv) the registration of directors of Sinovac Beijing will be restored. The parties of material interest in the AIC Decision may raise objection or file a lawsuit within 60 days. No one had filed the objection or lawsuit against the AIC Decision within 60 days thereof.
On December 24, 2018, Sinobioway Medicine filed a complaint against Sinovac Beijing in the Haidian District Court of Beijing.Court. The complaint seekssought a declaration that all the board resolutions passeddated September 5, 2018, including the composition of the board, the appointment of the senior managers and the management of the corporate seals, are invalid (“September 5 Board Resolution Case”). Sinovac Hong Kong has filed an application for adding itself as the third party in this lawsuit. The court decided to accept its application. As a result of Sinovac Hong Kong, which is deemed as a foreign entity under the PRC Civil Procedural Law, participating in the litigation, the Haidian Court does not have the jurisdiction over the case and has transferred the case to the Beijing Fourth Court. In January 2020, the Beijing Fourth Court requested all the participants in the litigation to submit evidence. Both Sinovac Beijing and Sinovac Hong Kong submitted all the valid evidence to the court in February and March 2020. Then, Sinobioway Medicine filed a request to the Beijing Fourth Court to voluntarily withdrew the case on February 28, 2018November 2, 2020. The Beijing Fourth Court supported such voluntary withdraw and made a ruling to appoint Mr. Weidong Yindismiss the case on November 6, 2020.
On July 25, 2019, Sinobioway Medicine filed a complaint against Sinovac Beijing in the Haidian Court. The complaint sought to request Sinovac Beijing to provide (i) all the corporate documents of Sinovac Beijing, including the Articles of Association and other senior management members are invalid. Asboard resolutions (ii) all the books and the related accounting vouchers and records of Sinovac Beijing, created from the date of January 1, 2017, and (iii) the monthly financial reports of Sinovac Beijing for the lawyers and auditors of Sinobioway Medicine to review and/or copy. The complaint also sought to request Sinovac Beijing to agree the auditors of Sinobioway to audit its annual and quarterly financial reports. On October 28, 2019, one judge of the Haidian Court held a preliminary and brief hearing and declared that the simplified procedures shall not apply to this annual report, both lawsuits are pendingcase, which shall be heard by a panel of three judges. On August 25, 2020, the Haidian Court issued a judgment only supporting Sinobioway Medicine’s request for inspecting and nocopying the Articles of Association and board resolutions of Sinovac Beijing and inspecting books and related accounting vouchers and records of Sinovac Beijing, and dismissing the rest of Sinobioway Medicine’s claims. Sinobioway Medicine filed a notice to appeal to Beijing First Intermediate Court on September 7, 2020. Neither party provided any new evidence nor questioned the procedures applied by Haidian Court. On March 15, 2021, after a hearing, has been held.the Beijing First Intermediate Court made a ruling after a hearing, rejecting the appeal made by Sinobioway Medicine and endorsing the judgment made by Haidian Court. The Company cannot predict whether an ultimate outcome will be favorable or unfavorable, nor estimate the amount or range of potential loss (if any) at this time.
lawsuit was closed.
Dividend Policy
We have never declared or paid any dividends, nor do we have any present plan to pay any cash dividends on our common shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business.
Our board of directors has complete discretion on whether to pay dividends. Even if our board of directors decides to pay dividends, the form, frequency and amount will depend upon our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant. Cash dividends on our common shares, if any, will be paid in U.S. dollars.
We are a holding company, and we rely on the dividends paid by our majority-owned subsidiaries, Sinovac Beijing, Sinovac Dalian and Sinovac Dalian,LS, and our wholly owned subsidiaries Sinovac R&D andsubsidiary Sinovac Biomed through Sinovac Hong Kong, for our cash needs, including the funds necessary to pay any dividends and other cash distributions to our shareholders, service any debt we may incur and pay our operating expenses. The payment of dividends in China is subject to limitations. Regulations in the PRC currently permit payment of dividends by our PRC subsidiaries only out of accumulated profits as determined in accordance with accounting standards and regulations in China. In accordance with the regulations in China, Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS and Sinovac Biomed are required to set aside at least 10% of its after-tax profits each year to contribute to its reserve fund until the accumulated balance of such reserve fund reaches 50% of the registered capital of each company. Sinovac Beijing, Sinovac Dalian, Sinovac R&DLS and Sinovac Biomed are required to set aside, at the discretion of their respective board of directors, a portion of its after-tax profits to their employee welfare and bonus funds.
Furthermore, pursuant to the double tax arrangement between Hong Kong and PRC, dividends paid by a foreign-invested enterprise in China to its direct holding company in Hong Kong will be subject to withholding tax at a rate of no more than 5% (if the foreign investor owns directly at least 25% of the shares of the foreign-invested enterprise for a period greater than 12 months), or otherwise 10%. WhetherPrior to May 2012, whether the favorable rate will be applicable to dividends received by Sinovac Hong Kong from our PRC subsidiaries is subject to the approval of the PRC tax authorities because it is unclear whether Sinovac Hong Kong is considered as the beneficial owner of the dividends in substance.authorities. The PRC tax authorities have discretion to assess whether a recipient of the PRC-sourced income is only an agent or a conduit, or lacks the requisite amount of business substance, in which case the application of the tax arrangement may be denied. This withholding tax imposed on dividends paid to us by our PRC subsidiaries would reduce our net income attributable to the shareholders. In May 2012, Sinovac Hong Kong was granted by the local tax bureau the preferential dividend withholding tax rate of 5% on dividends declared by Sinovac Beijing for three years from 2012 to 2014. The State Administration of Taxation has the authority to re-assess the approval of the preferential dividend withholding tax rate granted by the local tax bureau. The preferential dividend withholding tax rate expired in 2014. The dividends received by Sinovac Hong Kong from its PRC subsidiaries are subjectSubsequent to aMay 2012, the preferential dividend withholding tax rate no longer needed to be approved by the PRC tax authorities, instead companies can apply the 5% rate if a self-assessment determined the recipient of 10%.the PRC-sourced income qualify for the preferential rate. However, such self-assessment could be overturned upon an inspection by the PRC tax authorities. We will make such self-assessment when necessary and use the appropriate withholding tax rate based on the result of the assessment.
B. | Significant Changes |
Except with respect to the Exchange and the related issuance of common shares and Series B Preferred Shares pursuant to Sinovac Antigua’s Rights Agreement, as well as the related ongoing litigation, in each case disclosed elsewhere in this annual report, we have not experienced any significant changes since the date of our audited consolidated financial statements included in this annual report.
ITEM 9. | The Offer and Listing |
A. | Offer and Listing Details |
The table below sets forth, for the periods indicated, the high and low trading prices on the NASDAQ Global Market and the NASDAQ Global Select Market for our common shares.See “—C. Markets.”
| Trading Price | ||||||||
| High | Low | |||||||
| Annual High and Low | ||||||||
| 2013 | $ | 6.57 | $ | 3.00 | ||||
| 2014 | 8.14 | 4.51 | ||||||
| 2015 | 6.18 | 4.56 | ||||||
| 2016 | 7.16 | 4.38 | ||||||
| 2017 | 8.11 | 4.60 | ||||||
| Quarterly High and Low | ||||||||
| First Quarter 2016 | 7.16 | 4.38 | ||||||
| Second Quarter 2016 | 6.45 | 5.61 | ||||||
| Third Quarter 2016 | 6.01 | 5.50 | ||||||
| Fourth Quarter 2016 | 6.45 | 5.25 | ||||||
| First Quarter 2017 | 6.05 | 5.50 | ||||||
| Second Quarter 2017 | 6.92 | 4.60 | ||||||
| Third Quarter 2017 | 7.16 | 6.50 | ||||||
| Fourth Quarter 2017 | 8.11 | 6.81 | ||||||
| First Quarter 2018 | 8.75 | 7.83 | ||||||
| Monthly High and Low | ||||||||
| November 2017 | 7.98 | 6.96 | ||||||
| December 2017 | 8.11 | 7.60 | ||||||
| January 2018 | 8.67 | 7.83 | ||||||
| February 2018 | 8.49 | 7.95 | ||||||
| March 2018 | 8.75 | 8.06 | ||||||
| April 2018 | 8.59 | 6.65 | ||||||
| May 2018 (through May 10, 2018) | 7.83 | 7.22 | ||||||
B. | Plan of Distribution |
Not applicable.
C. | Markets |
Our common shares have been listed on the NASDAQ Global Select Market since January 3, 2011 under the symbol “SVA.” In connection with the Exchange and the issuance of the Exchange Shares into the Shareholder 2019 Rights Exchange Trust, trading of our common shares on Nasdaq has been halted since February 22, 2019.
D. | Selling Shareholders |
Not applicable.
E. | Dilution |
Not applicable.
F. | Expenses of the Issue |
Not applicable.
ITEM 10. | Additional Information |