Earnings release
Page 1
Reima BeiGene Reports First Quarter 2021 Financial Results Exhibit 99.1 • • Recorded product revenue of $ 106.1 million for the first quarter , compared to $ 52.1 million in the prior year period Included in China's National Reimbursement Drug List ( NRDL ) , effective March 1 , 2021 , significantly driving increased demand for tislelizumab , BRUKINSA® , and XGEVAⓇ Closed collaboration and license agreement with Novartis for tislelizumab , with $ 650 million up - front payment Received approval for Guangzhou biologics manufacturing facility , expanding commercial supply of tislelizumab in China and strategic capabilities CAMBRIDGE , Mass . and BEIJING , China , May 6 , 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 first quarter of 2021 . " We continue to make excellent progress across the board in advancing our key strategic objectives , including enhancing our commercial scale in China , working to broaden access to our medicines around the world through new regulatory filings , advancing our pipeline , including potentially first - in - class compounds and wholly owned combinations , and expanding our capabilities in biologics manufacturing . We are encouraged by the performance of our commercial portfolio since the implementation on March 1 of three innovative oncology products in the National Reimbursement Drug List in China , " said John V. Oyler , Co - Founder , Chief Executive Officer , and Chairman of BeiGene . “ In addition , we closed our license and collaboration agreement with Novartis , receiving a $ 650 million up - front payment , and recently announced positive interim results from our global Phase 3 head - to - head ALPINE trial in chronic lymphocytic leukemia , which we believe further demonstrates the differentiated and potentially best - in - class profile for BRUKINSA . We are confident in our strong position to deliver on our mission of providing high quality medicines to billions of more people around the world who need them . " Recent Business Highlights and Upcoming Milestones Commercial Operations • Generated $ 106.1 million in global product revenue in the three months ended March 31 , 2021 , representing a 104 % increase from $ 52.1 million in the comparable period of the prior year . Product sales in the first quarter grew over the prior year as well as sequentially compared to the prior quarter due to continued progress in our product launches , including significantly increased patient demand following the inclusion of tislelizumab , BRUKINSAⓇ , and XGEVAⓇ in the NRDL , effective March 1 , 2021 , which more than offset the net effect of price reductions as a result of NRDL inclusion ; First quarter product revenue grew sequentially despite a negative adjustment of $ 24.2 million as a result of the normal process in China of compensating distributors for products previously sold at the pre - NRDL price during the quarter that remained in the distribution channel , due to the first inclusion of tislelizumab , BRUKINSA , and XGEVA in the NRDL . The majority of the compensation related to tislelizumab ; Inclusion in the NRDL led to significant increases in the number of formal hospital listings for tislelizumab , BRUKINSA , and XGEVA to approximately 4x , 8x , and 6x their respective levels prior to NRDL inclusion ; and Sales of BRUKINSA in the United States continued steady growth despite the continued impact from COVID - 19 , including the vaccine rollout , on patient treatment plans . 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 . • Announced positive results from a planned interim analysis of the ongoing Phase 3 ALPINE trial ( NCT03734016 ) comparing BRUKINSA against ibrutinib in adults with relapsed or refractory ( R / R ) chronic lymphocytic leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ) ; Received approval and launched BRUKINSA in Canada for the treatment of adult patients with Waldenström's macroglobulinemia ( WM ) , based on the Phase 3 ASPEN trial comparing BRUKINSA and ibrutinib ; and Continued to advance BRUKINSA in new markets . BRUKINSA is now commercially available in Israel for patients with mantle cell lymphoma ( MCL ) who have received at least one prior therapy . To - date , more than 30 marketing