Item 2.02. Results of Operations and Financial Condition.
As required by the PRC Securities Laws, the Prospectus contains historical financial information of the Company that was prepared in accordance with the China Accounting Standards forBusiness Enterprises - Basic Standard ("CAS") and other applicable PRC accounting rules, guidance and interpretations, including but not limited to theChina Securities Regulatory Commission's Compilation Rule for Information Disclosure byCompanies Offering Securities to the Public No. 15 - General Rules for Financial Statement (2014 revised), and Compilation Rule for Information Disclosure byCompanies Offering Securities to the Public No. 24 - Special Provisions on Information Disclosure in Financial Statements of Pilot Innovative Red-chip Companies on the Sci-Tech Innovation Board (together with CAS, "PRC GAAP") for the years endedDecember 31, 2018 , 2019 and 2020 and the six months endedJune 30, 2021 , certain historical financial results for the nine months endedSeptember 30, 2021 . PRC GAAP are different from the accounting principles generally accepted inthe United States ("U.S. GAAP"). The key differences between such financial information prepared in accordance with PRC GAAP and those prepared in accordance withU.S. GAAP, which was previously filed with theU.S. Securities and Exchange Commission (the "SEC"), were summarized in the Company's Current Report on Form 8-K filed with theSEC onJune 30, 2021 . As required by the PRC Securities Laws, the Prospectus contains the Company's research and development expenses allocated by key products and other research and development projects ("R&D Expenses") for the years endedDecember 31, 2018 , 2019 and 2020, and the six months endedJune 30, 2021 ("Reporting Period") prepared in accordance with PRC GAAP. The R&D Expenses for the Reporting Period prepared in accordance withU.S. GAAP are attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. As required by the PRC Securities Laws, the Prospectus contains an estimated forecast of the preliminary range of certain financial results expected for the year endingDecember 31, 2021 , which mainly include the expected total revenue and the net loss attributable to the Company (the "Estimated Range of Financial Results").The Estimated Range of Financial Results is prepared in accordance with the PRC GAAP and presented in RMB. The Company's independent registered public accountants have not audited, reviewed or performed any procedures with respect to theEstimated Range of Financial Results and accordingly do not express an opinion or any other form of assurance with respect thereto.The Estimated Range of Financial Results could change as a result of further review and the actual results for the year endingDecember 31, 2021 could differ from theEstimated Range of Financial Results as a result of changes in underlying circumstances or events that cause management's assumptions and estimates to differ from current expectations. The correspondingEstimated Range of Financial Results prepared in accordance with the accounting principles generally accepted inthe United States are attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. -------------------------------------------------------------------------------- The Prospectus is publicly available in Chinese language only on the website maintained by theShanghai Stock Exchange at www.sse.com.cn. The Prospectus and the information contained on theShanghai Stock Exchange's website are not part of this Current Report on Form 8-K and shall not be deemed filed or furnished by the Company with theSEC , nor shall they be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended (the "Securities Act"), or the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The information in Item 2.02 of this Current Report on Form 8-K and in Exhibit 99.1 is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On
OnNovember 14, 2021 ,BeiGene andNewBridge Pharmaceuticals , a specialty company in theMiddle East andNorth Africa (MENA) regions established to bridge the access gap by partnering with global pharma and biotech companies, announced that BRUKINSA® (zanubrutinib) has received approval from theSaudi Food and Drug Authority (SFDA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.BeiGene andNewBridge Pharmaceuticals are working together to bring BRUKINSA to healthcare providers and people living with MCL inSaudi Arabia and other MENA markets following regulatory approvals. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. --------------------------------------------------------------------------------
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws, including statements regarding the Proposed Issue of RMB Shares under the general mandate to be listed on the STAR Market and theEstimated Range of Financial Results. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the possibility that the conditions, including market conditions, will not be met and thatBeiGene will be unable to consummate the Proposed Issue of RMB Shares; the possibility thatBeiGene will not realize the expected benefits of the transaction; the possibility that the final financial results will be different from the preliminaryEstimated Range of Financial Results;BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval;BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved;BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology;BeiGene's reliance on third parties to conduct drug development, manufacturing and other services;BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on theBeiGene's clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" inBeiGene's most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors inBeiGene's subsequent filings with theU.S. Securities and Exchange Commission . All information in this Current Report is as of the date of this Current Report, andBeiGene undertakes no duty to update such information unless required by law. The Proposed Issue of RMB Shares under the general mandate is subject to, among other things, market conditions, and thus may or may not proceed. Shareholders and potential investors of the Company should be aware that there is no assurance that the Proposed Issue of RMB Shares will materialize or as to when it may materialize. Shareholders and potential investors of the Company should exercise caution when dealing in the securities of the Company. Further announcement(s) or filings will be made by the Company in accordance with the applicable laws and regulations on any material updates and progress in connection with the Proposed Issue of RMB Shares as and when appropriate. This Current Report is for information purposes only and does not constitute any invitation or offer to acquire, purchase or subscribe for the securities of the Company.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Financial Information, furnished herewith 99.2 Press Release titled "BeiGene and NewBridge
Pharmaceuticals Announce Approval
inSaudi Arabia of BRUKINSA® (Zanubrutinib) for
the Treatment of Patients
with Relapsed or Refractory Mantle Cell
Lymphoma", issued by
November 14, 2021 . 104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
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