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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
______________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): July 10, 2023
BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)
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Cayman Islands | 001-37686 | 98-1209416 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
c/o Mourant Governance Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of Principal Executive Offices) (Zip Code)
+1 (345) 949-4123
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share | | BGNE | | The NASDAQ Global Select Market |
Ordinary Shares, par value $0.0001 per share* | | 06160 | | The Stock Exchange of Hong Kong Limited |
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.02. Termination of a Material Definitive Agreement.
As previously disclosed, on December 19, 2021, BeiGene Switzerland GmbH (“BeiGene Switzerland”), a wholly-owned indirect subsidiary of BeiGene, Ltd. (the “Company”), entered into an Option, Collaboration and License Agreement (the “Option Agreement”) with Novartis Pharma AG (“Novartis”), pursuant to which BeiGene Switzerland granted Novartis an exclusive time-based option to receive an exclusive license to develop, manufacture and commercialize the Company’s investigational TIGIT inhibitor ociperlimab in certain territories.
On July 10, 2023, BeiGene Switzerland and Novartis entered into a Mutual Termination and Release Agreement (the “Termination Agreement”) to mutually terminate the Option Agreement, effective immediately. Pursuant to the Termination Agreement, BeiGene Switzerland regained full, global rights to develop, manufacture and commercialize ociperlimab.
The foregoing description of the terms of the Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Termination Agreement, which the Company intends to file as an exhibit to a subsequent periodic report or on an amendment to this Current Report on Form 8-K.
Item 8.01. Other Events.
The Company will continue the enrollment of the Phase 3 AdvanTIG 302 trial of ociperlimab in combination with its anti-PD-1 antibody tislelizumab for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (“NSCLC”) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. Due to the changing treatment paradigm, the Company will discontinue the Phase 3 AdvanTIG 301 trial of ociperlimab in combination with tislelizumab versus durvalumab following concurrent chemoradiotherapy in patients with stage III unresectable NSCLC. The Company will carefully evaluate all available data to inform future development opportunities with ociperlimab.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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| Exhibit No. | | Description |
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| 104 | | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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Exhibit Index
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| Exhibit No. | | Description |
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| 104 | | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| BEIGENE, LTD. |
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Date: July 11, 2023 | By: | /s/ Chan Lee |
| Name: | Chan Lee |
| Title: | Senior Vice President, General Counsel |