Item 2.02. Results of Operations and Financial Condition.
On April 28, 2022, BeiGene, Ltd. (the "Company") filed its 2021 Annual Report
for the year ended December 31, 2021 (the "STAR Annual Report") with the Science
and Technology Innovation Board (the "STAR Market") of the Shanghai Stock
Exchange, which was prepared in accordance with the listing rules of the STAR
Market and the applicable securities laws and regulations of the Peoples'
Republic of China (the "PRC" and the "PRC Securities Laws").
As required by the PRC Securities Laws, the STAR Annual Report contains
additional financial information of the Company regarding the Company's gross
profit margin ratio, research and development expenses allocated by key products
and other research and development projects, and production, sales and inventory
stock units of key products, for the year ended December 31, 2021 (the
"Reporting Period"), prepared in accordance with the China Accounting Standards
for Business Enterprises - Basic Standard ("CAS") and other applicable PRC
accounting rules, guidance and interpretations (together with CAS, "PRC GAAP").
As required by the PRC Securities Laws, the STAR Annual Report also contains
financial information of the Company for the Reporting Period prepared in
accordance with PRC GAAP. PRC GAAP are different from accounting principles
generally accepted in the United States ("U.S. GAAP"). The financial information
regarding the Company's research and development expenses allocated by key
products and other research and development projects for the Reporting Period
and the Company's production, sales and inventory stock units of key products
for the Reporting Period prepared in accordance with U.S. GAAP as well as a
summary of the material differences between PRC GAAP and U.S. GAAP are attached
hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated
herein by reference.
The STAR Annual Report is available to the public in Chinese language only on
the website maintained by the Shanghai Stock Exchange at www.sse.com.cn. The
STAR Annual Report and the information contained on the Shanghai 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 the U.S. Securities and
Exchange Commission, 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 April 27, 2022, the Company issued a press release announcing that the
Independent Data Monitoring Committee (IDMC) determined at a pre-planned interim
analysis that RATIONALE 306, a global Phase 3 trial of tislelizumab in
combination with chemotherapy, had met the study's primary endpoint of overall
survival (OS) in patients with previously untreated advanced or metastatic
esophageal squamous cell carcinoma (ESCC). A copy of this press release is
attached hereto as Exhibit 99.2, and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 Financial Information, furnished herewith
99.2 Press release titled "Global Phase 3 Trial of BeiGene's PD-1 Inhibitor,
Tislelizumab, in Combination with Chemotherapy Meets Primary Endpoint in
First-Line Advanced Esophageal Squamous Cell Carcinoma" issued by BeiGene,
Ltd. on April 27, 2022.
104 The cover page from this Current Report on Form 8-K, formatted in Inline
XBRL
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