• Companies to Collaborate on the Commercialization of XGEVA® (denosumab), KYPROLIS® (car­filz­o­mib), and BLINCYTO® (blinatumomab) in China
• Companies to Jointly Develop 20 Amgen Oncology Pipeline Assets, with BeiGene Responsible for Development and Commercialization in China as Part of the Global Development Plan
• Amgen to Purchase Approximately $2.7 Billion of BeiGene Shares
• BeiGene to Hold Analyst and Investor Call on Thursday, Octo­ber 31 at 8:00 p.m. ET

Cambridge, MA and Beijing, China (Press Release) – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) and Amgen (NASDAQ: AMGN) today announced a global stra­te­gic on­col­ogy col­lab­o­ration for the com­mer­cial­iza­tion and devel­op­ment in China of Amgen’s XGEVA® (denosumab), KYPROLIS® (car­filz­o­mib), and BLINCYTO® (blinatumomab), and the joint global devel­op­ment of 20 on­col­ogy assets in Amgen’s pipe­line, with BeiGene responsible for devel­op­ment and com­mer­cial­iza­tion in China. In connection with the col­lab­o­ration, Amgen will purchase a 20.5% stake in BeiGene for approx­i­mately $2.7 billion in cash at $174.85 per American Depositary Share (ADS).

“Through this col­lab­o­ration, Amgen, a true bio­tech pioneer and leader in our industry, has recog­nized the transformative poten­tial of BeiGene’s unique clin­i­cal devel­op­ment capabilities to accelerate global drug devel­op­ment. We are thrilled to join forces with Amgen to realize the devel­op­ment and com­mer­cial­iza­tion of this broad on­col­ogy pipe­line with the aim of benefitting patients around the world,” said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. “In addi­tion, this alliance ex­pands the port­folio avail­able to our mar­ket-leading China commercial team, led by Dr. Xiaobin Wu, with the poten­tial to bring as many as eight internally discovered and in-licensed inno­va­tive treat­ments to cancer patients by the end of 2020.”

“This stra­te­gic col­lab­o­ration with BeiGene will enable Amgen to serve sig­nif­i­cantly more patients by ex­panding our reach in the world’s most populous country. We’ve chosen an inno­va­tive stra­te­gic col­lab­o­rator that can offer commercial and clin­i­cal reach with global quality standards,” said Robert A. Bradway, Amgen’s chairman and chief exec­u­tive officer. “Cancer is a leading cause of death in China and will only be­come a more pressing public health issue as the Chinese pop­u­la­tion ages. We look for­ward to work­ing with BeiGene to make a meaningful dif­fer­ence in the lives of millions of cancer patients in China and around the world.”

Key elements of the col­lab­o­ration in­clude:

Commercialization of Approved Products in China:

• Under the agree­ment, BeiGene will com­mer­cial­ize XGEVA, KYPROLIS and BLINCYTO in China for five or seven years, during which time the parties will equally share profits and losses. Following the com­mer­cial­iza­tion period, BeiGene will have the right to retain one prod­uct and will be entitled to re­ceive royalties on sales in China for an addi­tional five years on the prod­ucts not retained; and
• XGEVA (denosumab) was approved in China in 2019 for patients with giant cell tumor of the bone and is in devel­op­ment for prevention of skeletal-related events in cancer patients with bone metastases. KYPROLIS (car­filz­o­mib) is in late-stage devel­op­ment in China for patients with multiple myeloma, and BLINCYTO (blinatumomab) is in late-stage devel­op­ment in China as a treat­ment for adult patients with re­lapsed or re­frac­tory acute lymphoblastic leukemia (ALL).

Global Clinical Development:

• BeiGene has agreed to jointly develop 20 Amgen on­col­ogy pipe­line assets globally, which in­clude targeted small-molecule agents such as AMG 510, a first-in-class inves­ti­ga­tional KRAS G12C in­hib­i­tor, as well as BiTE® (Bispecific T cell Engager) anti­bodies, for solid and hema­to­logic malig­nan­cies;
• Amgen and BeiGene will co-fund global devel­op­ment costs, with BeiGene contributing up to $1.25 billion worth of devel­op­ment services and cash over the term of the col­lab­o­ration. BeiGene is entitled to re­ceive royalties from global sales of each prod­uct outside of China, with the exception of AMG 510;
• For each pipe­line asset that is approved in China, BeiGene will re­ceive commercial rights for seven years from approval, during which time the parties will share equally in profits and losses. BeiGene is also entitled to re­ceive royalties from sales in China for five years after the seven-year commercial term; and
• BeiGene will also have the right to retain approx­i­mately one of every three approved pipe­line assets, up to a total of six, other than AMG 510, for com­mer­cial­iza­tion in China, during which time the parties will share in profits and losses.

Amgen has agreed to purchase approx­i­mately $2.7 billion of BeiGene ordinary shares, at a price of $174.85 per ADS, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Octo­ber 30, 2019. Amgen will re­ceive one seat on BeiGene’s Board of Directors.

The trans­actions have been approved by the boards of directors of both com­pa­nies and are ex­pec­ted to close in the first quarter of 2020, subject to approval by a majority vote of BeiGene’s share­holders pursuant to the listing rules of the Hong Kong Stock Exchange, the expiration or termination of appli­cable waiting periods under appli­cable antitrust laws, and satisfaction of other customary closing con­di­tions. BeiGene has already re­ceived commitments from share­holders holding approx­i­mately 40% of its outstanding shares to vote in favor of the trans­actions.

Morgan Stanley is acting as financial advisor to BeiGene. Mintz Levin served as legal advisor to BeiGene for the col­lab­o­ration agree­ment; Goodwin Procter served as legal advisor to BeiGene for the share purchase agree­ment; and Skadden served as legal advisor to BeiGene for Hong Kong Stock Exchange listing matters.

BeiGene Conference Call and Webcast Information

Investors and analysts are invited to join the conference call on Thursday, Octo­ber 31 at 8:00 p.m. ET using the fol­low­ing dial-in in­for­ma­tion:

U.S. Toll-Free: +1 (844) 461-9930
Hong Kong: +852 5819-4851
China: +86 400-682-8609
Conference ID: 7690259

A live webcast of the conference call can be accessed from the in­vestors section of BeiGene’s website at http://ir.beigene.com/ or http://hkexir.beigene.com. An archived replay will be avail­able two hours after the event for 90 days.

About BeiGene

BeiGene is a global, commercial-stage, research-based bio­technology com­pany focused on molecularly-targeted and immuno-oncology cancer thera­peutics. With a team of over 3,000 employees in China, the United States, Australia and Europe, BeiGene is ad­vanc­ing a pipe­line con­sist­ing of novel oral small molecules and mono­clonal anti­bodies for cancer. BeiGene is also work­ing to create com­bi­na­tion solu­tions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene mar­kets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lena­lido­mide), and VIDAZA® (azacitidine) in China under a license from Celgene Corpo­ra­tion.¹

BeiGene Forward-Looking Statements

This press release con­tains for­ward-looking state­ments within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 and other federal se­cu­ri­ties laws, in­clud­ing state­ments re­gard­ing BeiGene’s plans and ex­pec­ta­tions for the further devel­op­ment and poten­tial com­mer­cial­iza­tion of XGEVA, KYPROLIS, BLINCYTO and Amgen’s on­col­ogy pipe­line assets, the timing of approvals of BeiGene’s commercial prod­ucts in China, the parties’ commitments and the poten­tial benefits of the col­lab­o­ration, and the con­di­tions to closing and ex­pec­ted timing for the closing of the trans­actions. Actual results may differ ma­teri­ally from those in­di­cated in the for­ward-looking state­ments as a result of various im­por­tant factors, in­clud­ing 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 prod­ucts and drug can­di­dates, if approved; BeiGene's ability to obtain and main­tain pro­tec­tion of intellectual property for its tech­nology and drugs; BeiGene's reliance on third parties to conduct drug devel­op­ment, manu­fac­tur­ing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain addi­tional funding for operations and to com­plete the devel­op­ment and com­mer­cial­iza­tion of its drug can­di­dates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of poten­tial risks, un­cer­tainties, and other im­por­tant factors in BeiGene's sub­se­quent filings with the U.S. Se­cu­ri­ties and Exchange Com­mis­sion. All in­for­ma­tion in this press release is as of the date of this press release, and BeiGene under­takes no duty to update such in­for­ma­tion unless required by law.

Footnotes

¹ ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of Celgene Corpo­ra­tion.

Source: Beigene.