Home » Press Releases

Amgen Enters Into Strategic Collaboration With BeiGene To Expand Oncology Presence In China

Published: Oct 31, 2019 4:00 pm
  • Amgen to Acquire 20.5% Stake in BeiGene for Approximately $2.7 Billion in Cash
  • BeiGene to Commercialize XGEVA® (denosumab), KYPROLIS® (car­filz­o­mib) and BLINCYTO® (blinatumomab) in China
  • Companies to Collaborate on Advancing Amgen's Innovative Oncology Pipeline in China
  • Amgen Will Continue to Commercialize its Non-Oncology Product Portfolio in China
  • Amgen to Host Call for Investors Today at 2 p.m. PT

Amgen Enters Into Strategic Collaboration With BeiGene To Expand Oncology Presence In China Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) announced today that it has entered into a stra­te­gic col­lab­o­ration with BeiGene that will sig­nif­i­cantly accelerate Amgen's plans to ex­pand its on­col­ogy presence in China, the world's second-largest pharma­ceu­tical mar­ket. BeiGene is a research-based, on­col­ogy-focused bio­tech­nology com­pany with an estab­lish­ed and highly ex­peri­enced team in China, in­clud­ing a 700-person commercial or­ga­ni­za­tion and a 600-person clin­i­cal devel­op­ment or­ga­ni­za­tion.

"This stra­te­gic col­lab­o­ration with BeiGene will enable Amgen to serve sig­nif­i­cantly more patients by ex­panding our presence in the world's most populous country," 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. With its extensive commercial and clin­i­cal capabilities within China and a commitment to global quality standards, BeiGene is the ideal stra­te­gic col­lab­o­rator as we seek to make a meaningful dif­fer­ence in the lives of millions of cancer patients in China and around the world."

As part of the col­lab­o­ration:

  • Amgen will acquire a 20.5% stake in BeiGene for approx­i­mately $2.7 billion in cash. This rep­re­sents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene's 30-day volume-weighted average share price as of Oct. 30, 2019. Amgen will nominate one person to serve on BeiGene's Board of Directors.
  • Under the agree­ment, BeiGene will com­mer­cial­ize XGEVA® (denosumab), KYPROLIS® (car­filz­o­mib) and BLINCYTO® (blinatumomab) in China during which time the parties will equally share profits and losses. Two of these prod­ucts will revert to Amgen, one after five years and one after seven years. 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. XGEVA was launched in China in Sep­tem­ber of this year; KYPROLIS and BLINCYTO are both in Phase 3 trials in China.
  • Amgen and BeiGene will col­lab­o­rate to ad­vance 20 med­i­cines from Amgen's inno­va­tive on­col­ogy pipe­line in China and globally. BeiGene will share global research and devel­op­ment costs and con­trib­ute up to $1.25 billion to ad­vance these med­i­cines. Amgen will pay royalties to BeiGene on the sales of these prod­ucts outside of China, with the exception of AMG 510, Amgen's first-in-class KRASG12C in­hib­i­tor that is being studied as a poten­tial treat­ment for solid tumors. Amgen antic­i­pates uti­liz­ing data from clin­i­cal trials conducted in China to ad­vance the devel­op­ment of its on­col­ogy port­folio globally.
  • Of the 20 on­col­ogy med­i­cines in devel­op­ment, BeiGene will assume commercial rights in China for seven years after launch for those that re­ceive approval in China, in­clud­ing AMG 510. After this time, BeiGene will retain rights to up to six of these prod­ucts in China, excluding AMG 510, while rights on remaining prod­ucts revert to Amgen. Amgen and BeiGene will share profits in China equally on these prod­ucts until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.
  • Amgen will con­tinue to com­mer­cial­ize its non-oncology prod­uct port­folio in China. Earlier this year, Amgen launched its first-ever prod­uct in China, Repatha® (evolocumab), an LDL cholesterol-lowering treat­ment proven to reduce the risk of heart attacks and stroke. Amgen ex­pec­ts to launch a number of other non-oncology med­i­cines in China over the next several years, in­clud­ing Prolia® (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.
  • XGEVA, KYPROLIS and BLINCYTO, as well as the med­i­cines in Amgen's on­col­ogy pipe­line, will be manu­fac­tured at Amgen's existing facilities.

Since 2011, Amgen has ex­panded its geographic presence from approx­i­mately 50 to 100 countries, enabling the com­pany to play a growing role in serving the rapidly in­creas­ing demand for better health­care around the world. The pharma­ceu­tical mar­ket in China is ex­pec­ted to grow briskly as access to new med­i­cines con­tinues to im­prove. With approx­i­mately four million people diag­nosed with cancer annually and 2.3 million deaths from the dis­ease each year, the need for new on­col­ogy treat­ments in China is particularly acute and the on­col­ogy mar­ket is one of the fastest-growing segments of the over­all pharma­ceu­tical mar­ket there.

Amgen will purchase its equity stake in BeiGene with avail­able cash and ex­pec­ts to retain its investment grade credit rating.

"Amgen's capital allocation priorities remain unchanged," said David W. Meline, exec­u­tive vice pres­i­dent and chief financial officer at Amgen. "We will con­tinue to grow our business through internal investment and business devel­op­ment, while providing attractive returns to our share­holders through a growing dividend and con­tinued share repurchases."

The trans­action is ex­pec­ted to close in early 2020 subject to BeiGene share­holder approval, the expiration or termination of waiting periods under all appli­cable antitrust laws, and satisfaction of other customary closing con­di­tions.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Latham & Watkins LLP is serving as legal advisor to Amgen.

Webcast Details

Amgen will host a webcast call today at 2 p.m. PT. where members of Amgen's exec­u­tive man­age­ment team will discuss the Com­pany's stra­te­gic col­lab­o­ration with BeiGene.

Live audio webcast of the in­vestor call will be broadcast over the internet simultaneously and will be avail­able to members of the news media, in­vestors and the general public.

The webcast, as with other selected presentations re­gard­ing devel­op­ments in Amgen's business given at cer­tain in­vestor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information re­gard­ing presentation times, webcast avail­a­bil­ity and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and avail­able for replay for at least 90 days after the event.

For more in­for­ma­tion about Amgen's prod­ucts, in­clud­ing im­por­tant safety in­for­ma­tion, please visit www.xgeva.com, www.kyprolis.com, www.blincyto.com, www.repatha.com, and www.prolia.com.

About Amgen

Amgen is committed to unlocking the poten­tial of biology for patients suffer­ing from serious illnesses by discovering, devel­op­ing, manu­fac­tur­ing and de­livering inno­va­tive human thera­peutics. This ap­proach begins by using tools like ad­vanced human genetics to unravel the complexities of dis­ease and under­stand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manu­fac­tur­ing ex­per­tise to strive for solu­tions that im­prove health out­comes and dramatically im­prove people's lives. A bio­tech­nology pioneer since 1980, Amgen has grown to be the world's largest independent bio­tech­nology com­pany, has reached millions of patients around the world and is devel­op­ing a pipe­line of med­i­cines with break­away poten­tial.

For more in­for­ma­tion, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release con­tains for­ward-looking state­ments that are based on the current ex­pec­ta­tions and beliefs of Amgen. All state­ments, other than state­ments of historical fact, are state­ments that could be deemed for­ward-looking state­ments, in­clud­ing any state­ments on the out­come, benefits and synergies of the BeiGene stra­te­gic col­lab­o­ration, in­clud­ing the impact on non-GAAP EPS, as well as esti­mates of revenues, operating margins, capital ex­pen­di­tures, cash, other financial metrics, ex­pec­ted legal, arbitration, political, regu­la­tory or clin­i­cal results or practices, customer and prescriber patterns or practices, reim­burse­ment activities and out­comes and other such esti­mates and results. Forward-looking state­ments in­volve­ sig­nif­i­cant risks and un­cer­tainties, in­clud­ing those discussed below and more fully described in the Se­cu­ri­ties and Exchange Com­mis­sion reports filed by Amgen, in­clud­ing our most recent annual report on Form 10-K and any sub­se­quent periodic reports on Form 10-Q and current reports on Form 8-K. Unless other­wise noted, Amgen is providing this in­for­ma­tion as of the date of this news release and does not under­take any obli­ga­tion to update any for­ward-looking state­ments con­tained in this document as a result of new in­for­ma­tion, future events or other­wise.

No for­ward-looking state­ment can be guar­an­teed and actual results may differ ma­teri­ally from those we project. Our results may be affected by our ability to suc­cess­fully mar­ket both new and existing prod­ucts domestically and inter­na­tionally, clin­i­cal and regu­la­tory devel­op­ments involving current and future prod­ucts, sales growth of recently launched prod­ucts, com­pe­ti­tion from other prod­ucts in­clud­ing bio­sim­i­lars, dif­fi­culties or delays in manu­fac­tur­ing our prod­ucts and global economic con­di­tions. In addi­tion, sales of our prod­ucts are affected by pricing pressure, political and public scrutiny and reim­burse­ment policies imposed by third-party payers, in­clud­ing gov­ern­ments, private insurance plans and man­aged care providers and may be affected by regu­la­tory, clin­i­cal and guideline devel­op­ments and domestic and inter­na­tional trends to­ward man­aged care and health­care cost con­tainment. Further­more, our research, testing, pricing, mar­ket­ing and other operations are subject to extensive reg­u­la­tion by domestic and foreign gov­ern­ment regu­la­tory author­i­ties. We or others could identify safety, side effects or manu­fac­tur­ing problems with our prod­ucts, in­clud­ing our devices, after they are on the mar­ket. Our business may be impacted by gov­ern­ment in­ves­ti­ga­tions, lit­i­ga­tion and prod­uct liability claims. In addi­tion, our business may be impacted by the adoption of new tax legislation or exposure to addi­tional tax liabilities. If we fail to meet the compliance obli­ga­tions in the corporate integrity agree­ment be­tween us and the U.S. gov­ern­ment, we could be­come subject to sig­nif­i­cant sanctions. Further, while we routinely obtain patents for our prod­ucts and tech­nology, the pro­tec­tion offered by our patents and patent appli­ca­tions may be chal­lenged, invalidated or circumvented by our com­pet­i­tors, or we may fail to prevail in present and future intellectual property lit­i­ga­tion. We per­form a sub­stan­tial amount of our commercial manu­fac­tur­ing activities at a few key facilities, in­clud­ing in Puerto Rico, and also depend on third parties for a portion of our manu­fac­tur­ing activities, and limits on supply may constrain sales of cer­tain of our current prod­ucts and prod­uct can­di­date devel­op­ment. We rely on col­lab­o­rations with third parties for the devel­op­ment of some of our prod­uct can­di­dates and for the com­mer­cial­iza­tion and sales of some of our commercial prod­ucts. In addi­tion, we compete with other com­pa­nies with respect to many of our mar­keted prod­ucts as well as for the discovery and devel­op­ment of new prod­ucts. Discovery or identi­fi­ca­tion of new prod­uct can­di­dates or devel­op­ment of new in­di­ca­tions for existing prod­ucts cannot be guar­an­teed and movement from concept to prod­uct is un­cer­tain; consequently, there can be no guar­an­tee that any particular prod­uct can­di­date or devel­op­ment of a new in­di­ca­tion for an existing prod­uct will be suc­cess­ful and be­come a commercial prod­uct. Further, some raw ma­teri­als, medical devices and component parts for our prod­ucts are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have sub­stan­tial purchasing leverage in their dealings with us. The discovery of sig­nif­i­cant problems with a prod­uct similar to one of our prod­ucts that implicate an entire class of prod­ucts could have a ma­teri­al adverse effect on sales of the affected prod­ucts and on our business and results of operations. Our efforts to col­lab­o­rate with or acquire other com­pa­nies or prod­ucts and to integrate the operations of com­pa­nies or in sup­port of prod­ucts we have acquired may not be suc­cess­ful. A breakdown, cyberattack or in­for­ma­tion se­cu­ri­ty breach could compromise the con­fi­den­tiality, integrity and avail­a­bil­ity of our sys­tems and our data. Our stock price is volatile and may be affected by a number of events. Our business per­for­mance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit mar­kets on terms that are favorable to us, or at all.

Source: Amgen.



Related Press Releases: