Earnings release
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G Exhibit 99.1 • BeiGene Reports Second Quarter 2021 Financial Results Recorded product revenue of $ 138.6 million for the second quarter , representing a 111 % increase from $ 65.6 million in the prior year period ; additional approvals of five new indications and two new products in China Reported positive interim Phase 3 BRUKINSA data from two global trials in chronic lymphocytic leukemia or small lymphocytic lymphoma : SEQUOIA in front - line and ALPINE in relapsed or refractory setting • Initiated two Phase 3 clinical trials in NSCLC of ociperlimab , an investigational anti - TIGIT monoclonal antibody with competent Fc function • Announced plans to expand global manufacturing capabilities through establishment of a U.S. facility CAMBRIDGE , Mass . and BEIJING , China , August 5 , 2021 -- BeiGene , Ltd. ( NASDAQ : BGNE ; HKEX : 06160 ) , a global biotechnology company focused on developing and commercializing innovative medicines worldwide , today reported recent business highlights , anticipated upcoming milestones , and financial results for the second quarter and six months ended June 30 , 2021 . " We continued executing on our key strategic objectives during the second quarter and took steps to further position BeiGene to become highly impactful to oncology patients worldwide , " said John V. Oyler , Co - Founder , Chairman and Chief Executive Officer of BeiGene . " We are broadening global access to our medicines through approvals of five new indications and two new products in China as well as additional marketing approvals and commercialization for BRUKINSA in Chile , UAE , and Israel , new regulatory submissions for BRUKINSA in multiple geographies , and the advancement of our internally developed and in - licensed product candidates . Three key pipeline achievements include : first , continued clinical evidence for the best - in - class potential of BRUKINSA , as demonstrated by the results of the global SEQUOIA and ALPINE trials , which both had positive readouts at the interim for efficacy outcomes as well as safety consistent with what we have observed in its global development program with more than 2,300 patients treated to date ; second , the expanded list of indications for tislelizumab in China , reflecting its potential for reimbursement in China and the potential for regulatory filings in other geographies across the globe ; and third , progress with our differentiated Phase 3 stage , anti - TIGIT antibody , ociperlimab , which we believe is one of the most advanced anti - TIGIT molecules in development worldwide . We also continued to build key strategic capabilities in house including our research , clinical development , commercial and manufacturing infrastructure , including our plans to establish a U.S. commercial - stage manufacturing and clinical R & D site . We remain on track in our mission of bringing innovative and accessible medicines to billions more patients around the world . " Recent Business Highlights and Upcoming Milestones Commercial Operations • Product sales grew due to continued progress of our product launches , with sales of BRUKINSA in the United States continuing to accelerate , and sales in China delivering significantly increased patient demand in the first full quarter following the inclusion of tislelizumab , BRUKINSA® , and XGEVAⓇ on the National Reimbursement Drug List ( NRDL ) , which became effective on March 1 , 2021 ; and Inclusion in the NRDL led to significant increases in the number of formal hospital listings for tislelizumab , BRUKINSA , and XGEVA in the second quarter of 2021 to approximately 13x , 28x , and 23x versus their respective levels prior to NRDL inclusion . Development Programs BRUKINSA® ( zanubrutinib ) , a small molecule inhibitor of Bruton's tyrosine kinase ( BTK ) designed to maximize BTK occupancy and minimize off - target effects , approved in the United States , China , Canada , and other international markets in selected indications and under development for additional approvals globally . • • Received conditional approval from the China National Medical Products Administration ( NMPA ) for the treatment of adult patients with Waldenström’s macroglobulinemia ( WM ) who have received at least one prior therapy ; Received acceptance of a supplemental new drug application ( SNDA ) and was granted priority review by the U.S. Food and Drug Administration ( FDA ) for the treatment of adult patients with marginal zone lymphoma ( MZL ) who have received at least one prior anti - CD20 - based therapy . The Prescription Drug User Fee Act ( PDUFA ) date is September 19 , 2021 ;