What is the primary reason for the termination notice from BMS-Celgene?

BMS-Celgene cited the National Medical Products Administration's (NMPA) decision to suspend ABRAXANE® importation, sales, and use in China, as well as manufacturing failures at their Phoenix facility, leading to cessation of production. They claim these issues justify withdrawing ABRAXANE® from the Chinese market under the agreement.

Does BeOne Medicines Ltd. agree with the termination notice?

No, BeOne Medicines Ltd. believes the reasons stated by BMS-Celgene do not provide a valid basis for termination. They view the notice as a tactical move by BMS-Celgene to reduce its damages in the ongoing arbitration and intend to contest it vigorously.

What is the status of the arbitration proceedings?

BeOne Medicines Ltd. is engaged in arbitration proceedings at the International Chamber of Commerce (ICC) against BMS-Celgene. BeOne is seeking a declaration that BMS-Celgene breached the agreement, acted with gross negligence, and is claiming damages due to failures in supply continuity and adequacy of ABRAXANE®.

What are the recent positive developments for BeOne Medicines Ltd. mentioned in the filing?

The filing also announced positive news regarding BeOne's drug BRUKINSA® (zanubrutinib). BRUKINSA® received regulatory approval in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia and Mantle Cell Lymphoma.

ONC/BEIGF 8-K: Material Agreements

Summary

BeOne Medicines Ltd. (ONC) filed an 8-K on October 13, 2021, primarily addressing a significant development regarding the termination of a material definitive agreement. Bristol Myers Squibb (BMS-Celgene) has issued a notice purporting to terminate their License and Supply Agreement concerning ABRAXANE®, REVLIMID®, and VIDAZA® in China. This termination specifically relates to ABRAXANE® and is to be effective in 180 days, with BMS-Celgene citing ongoing manufacturing issues and regulatory suspensions as justification. BeOne Medicines Ltd. disputes the validity of this termination, believing it to be a tactic to reduce damages in ongoing arbitration proceedings where BeOne is seeking damages for BMS-Celgene's alleged breaches, including failure to ensure adequate supply. This development poses a significant risk to BeOne's distribution rights for ABRAXANE® in China, a key territory. In parallel, the report also highlights positive news regarding the Australian regulatory approvals for BeOne's drug BRUKINSA® (zanubrutinib) for Waldenström’s macroglobulinemia and Mantle Cell Lymphoma. These approvals represent market expansion and commercial progress for BRUKINSA® in a new geography. Investors should closely monitor the arbitration proceedings and the legal challenges to the ABRAXANE® termination, as well as the commercial trajectory of BRUKINSA® in Australia and other markets.

Key Highlights

1BMS-Celgene has issued a notice to terminate the License and Supply Agreement concerning ABRAXANE® in China, with a 180-day notice period.
2BeOne Medicines Ltd. disputes the validity of BMS-Celgene's termination notice and intends to contest it vigorously in ongoing arbitration.
3The termination notice stems from ongoing manufacturing issues and NMPA suspension of ABRAXANE® supply.
4BeOne Medicines Ltd. is currently engaged in arbitration proceedings against BMS-Celgene seeking damages for alleged breaches of the agreement.
5BRUKINSA® (zanubrutinib) received regulatory approval in Australia for Waldenström’s macroglobulinemia.
6BRUKINSA® (zanubrutinib) also received regulatory approval in Australia for Mantle Cell Lymphoma.

BeOne Medicines Ltd. 8-K Report, Agreement Terminated (Oct 13, 2021)

Summary

Key Highlights

Frequently Asked Questions