BeiGene Announces Financial Results for the First Quarter of 2021

Perrier Chak ^® (imatinib Zerbe): a target designed to maximize market share, minimize off-target effects of small molecule Bruton's tyrosine kinase ( BTK ) inhibitor, in the United States, China, Canada and Other international markets have been approved for specific indications, and more approval processes are currently underway globally

• Perrier announced Ze ^® the ALPINE.
  
  
  • As early as 2021 Perrier announced Chak ^® SEQUOIA 3 clinical trial (NCT03336333) comparing bendamustine Ting Jiali rituximab for the treatment of patients with previously untreated CLL or SLL main results
  • The interim results of the ALPINE Phase 3 clinical trial (NCT03734016) will be announced at an important medical meeting in 2021, and the final results will be announced in 2022
  • Continue to promote Perrier Chak worldwide ^® new indications registered projects, including 2021 in the Middle East, South America, Canada, Australia and Russia potentially approved for the treatment of specific patients with MCL, as well as in the United States, European Union, China and Australia Potentially approved for the treatment of WM patients
  • Perrier-taek will be completed in 2021 ^® joint Obi Obi contrast trastuzumab trastuzumab as a single agent for the treatment of R / R follicular lymphoma (FL) patients ROSEWOOD global pivotal Phase 2 clinical trials (NCT03332017) Enrollment of patients

  One hundred ZeAn ^® ( for Rayleigh daclizumab): a is designed to avoid macrophage Fc binding receptor, immune checkpoint receptor PD-1 human humanized IgG4 monoclonal antibody

  
  
  • A collaboration and licensing agreement with Novartis reached into effect, authorize Novartis developed in North America, Europe and Japan, production and commercialization of Chak one hundred ^® and a $ 650 million advance payment
  • Announced that China State Drug Administration (NMPA) Center for Drug Evaluation (CDE) has accepted one hundred Chak ^® for the treatment of platinum-based receiving two or three lines whose disease progressed after chemotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) Patient’s New Indication Marketing Application (sBLA)
  • A one hundred Chak ^® joint research and development of pharmaceuticals and yellow Furosemide quinoline imatinib start patients enrolled in clinical trials for the world's two solid tumors (NCT04716634)
  • A one hundred Chak ^® with or without etoposide and platinum-based chemotherapy for the treatment of previously untreated 3 clinical trial (NCT04005716) in patients with extensive-stage small cell lung cancer treatment received has completed all the patients enrolled
  • An oral report published in 2021 Annual Meeting of the American Association for Cancer Research (AACR) in a hundred Chak ^® Comparison of docetaxel in locally advanced for a second or third line or 303 clinical trials worldwide 3 RATIONALE patients with metastatic NSCLC (NCT03358875 ) Interim results

  Chak one hundred ^® anticipated milestone events

  • In cooperation with Novartis, the first new drug marketing authorization application (BLA) will be submitted outside China in 2021
  • SBLAs for MSI-H/dMMR solid tumors and second-line esophageal squamous cell carcinoma (ESCC) will be submitted in China in the first half of 2021 and mid-2021, respectively
  • Will be approved in China in 2021 for the treatment of first-line non-squamous NSCLC patients and for the treatment of second or third-line hepatocellular carcinoma (HCC) patients
  • Clinical data will be announced at the American Society of Clinical Oncology (ASCO) 2021 online annual meeting, including the following poster presentations:
    • A one hundred ZeAn ^® Comparative chemotherapy RATIONALE 302 clinical trial wire advanced unresectable for ESCC patients (NCT03430843)
    • A one hundred ZeAn ^® locally advanced as a single agent for the treatment of previously treated unresectable or MSI-H / MRD 2 clinical trials in patients with solid tumors (NCT03736889)
  • 2021 will be announced a one hundred Chak ^® is mainly the result of combination chemotherapy vs Placebo in combination with chemotherapy for first-line treatment of nasopharyngeal carcinoma (NPC) patients in Phase 3 clinical trials (NCT03924986)
  • Will complete a one hundred Chak 2021 ^® vs Placebo combined radiotherapy and chemotherapy for the treatment of patients enrolled limitations ESCC patients 3 clinical trial (NCT03957590) of

  Pamiparib: a highly selective PARP1 and PARP2 small molecule inhibitor under research

  Pamipalli anticipates milestones

  • Approved in China in the first half of 2021 for the treatment of patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have previously received at least two lines of chemotherapy and have germline BRCA mutations
  • The main results of the Phase 3 clinical trial (NCT03519230) of pamidril as maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer (OC) will be announced in 2021 or the first half of 2022
  • Clinical data will be announced at the ASCO 2021 online annual meeting, including the following poster presentations:
    • A phase 2 clinical trial of Pamiparib in China for the treatment of locally advanced or metastatic HER2-negative breast cancer patients with germline BRCA mutations (NCT03575065)
    • A phase 2 clinical trial of pamiparib versus placebo as a maintenance treatment for patients with inoperable locally advanced or metastatic gastric cancer who responded to platinum-based first-line chemotherapy (NCT03427814)

  Ociperlimab (BGB-A1217 ) : A TIGIT monoclonal antibody under research with potent Fc function

  • Carry out patient enrollment in the following clinical trials:
    • A joint ociperlimab one hundred ZeAn ^® for the treatment of previously treated AdvanTIG-202 2 clinical trials (NCT04693234) recurrent or metastatic cervical cancer patients treated
    • A Phase 2 clinical trial of AdvanTIG-203 in the treatment of patients with unresectable, locally advanced, relapsed or metastatic ESCC with high PD-L1 expression in combination with ociperlimab ^® vs.
      
      
      • Will publish a joint ociperlimab Chak one hundred years in the ASCO 2021 Annual Meeting in line ^® 1 dose-for the treatment of patients with advanced solid tumors escalation trial (NCT04047862) clinical data
      • The first half of 2021 will launch a joint one hundred ociperlimab Chak ^® for the treatment of PD-L1 expression and locally advanced non-line-sensitive EGFR mutations or ALK translocations, global 3 patients with unresectable or metastatic NSCLC AdvanTIG-302 Enrollment of patients in Phase 1 clinical trial (NCT04746924)
      • 2021 will launch a joint one hundred ociperlimab Chak ^® and concurrent radiotherapy and chemotherapy for the treatment had not received previous treatment of locally advanced unresectable AdvanTIG-301 clinical trial (NCT04866017) Global 3 of NSCLC patients were enrolled

      Early independent research and development projects

      • Announced that a phase 1 clinical trial (NCT04649385) of the hematopoietic stem cell kinase 1 (HPK1) inhibitor BGB-15025 has been administered to the first patient
        
        
        • A Phase 1 clinical trial (NCT04771130) of BeiGene's ongoing BCL-2 inhibitor BGB-11417 for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) will be launched in 2021
          
          
          • The sBLA of BLINCYTO ^® belintoomab for injection for children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) has been accepted in China and included in priority review

          Other cooperation projects

          Sitravatinib: A receptor tyrosine kinase (RTK) inhibitor under investigation, which inhibits TAM (TYRO3, AXL, MERTK) receptor family, split receptor family (VEGFR 2 and KIT) and RET

          
          
          • Chak one hundred published in two oral report AACR 2021 Annual Meeting in ^® clinical data sitravatinib joint development cooperation with Mirati Therapeutics
            
            
            • NMPA has announced the approval of Guangzhou production base for biological drugs carry one hundred Chak ^® commercial production
              
              
              • The company expects that the global health crisis caused by the new crown pneumonia virus (COVID-19) will continue to have a certain negative impact on its business, including commercial sales, drug administration communication, inspections and declarations, patients in clinical trials, participation, and data release
                
                
                • Announced the appointment of Julia Wang () as chief financial officer, which will be officially effective on June 30, 2021
                  
                  

                  Cash, cash equivalents, restricted funds, and short-term investmentsfor the three months ended March 31, 2021.

                  
                  
                  • The cash used in operating activities for the three months ended March 31, 2021 was US$125.
                    1 million, including US$650 million received as an advance in the cooperation agreement with Novartis; capital expenditures were US$402.
                    4 million; and the use of advance payments for authorized drugs Cash was US$85 million; cash from raised funds was US$107.
                    4 million, including bank loans and the exercise of employee stock options
                  • RevenueRevenue for the three months ending March 31, 2021 was US$605.
                    9 million; compared to US$502.
                    1 million in the same period last year
                  • Product revenue for the three months ending March 31, 2021 was US$106.
                    1 million; compared to US$52.
                    1 million in the same period last year
                    .
                    Income includes:
                    • Chak one hundred ^® product revenue in China was US $ 048.
                      9 million; compared to the same period last year revenue of $ 020.
                      5 million
                    • Perrier Chak ^® product revenue was $ 022.
                      1 million; compared to the same period last year revenue of $ 000.
                      7 million
                    • Amgen licensed Baiji China sales in China's first product An Jiawei ^® product revenue of $ 014.
                      5 million
                      .
                      Since its start in July 2020 An Jiawei ^® Sales Activities
                    • The product revenue of Bristol-Myers Squibb’s authorized sales of products in China was US$200.
                      3 million; compared with US$300.
                      8 million in the same period last year
                      .
                      Product revenue declined in this quarter, mainly due to Bristol-Myers Squibb’s voluntary product recall after NMPA suspended the supply of ABRAXANE ^® in March 2020
                  • Revenue from cooperative projects for the three months ended March 31, 2021 was US$499.
                    8 million, mainly from the partial recognition of Novartis’ total US$650 million advance payment revenue
                    .
                    No revenue from cooperative projects in the same period last year
                  • Expenses  Expenses for the three months ending March 31, 2021 are $535.
                    7 million; compared to $425.
                    8 million in the same period last year
                  • Cost  of sales The cost of sales for the three months ending March 31, 2021 was US$33.
                    27 million; compared to US$14.
                    10 million in the same period last year
                    .
                    Increase in cost of sales was mainly due to one hundred Chak ^® , Perrier Chak ^® and An Jiawei ^® product sales to increase, when part of the Bristol-Myers Squibb Company licensed product sales offset sales decline
                  • Research and development ( R&D ) expenses The  research and development expenses for the three months ending March 31, 2021 were US$320.
                    7 million; in comparison, the research and development expenses for the same period last year were US$304.
                    3 million
                    .
                    The increase in R&D expenses is mainly attributable to the continued increase in costs for ongoing and newly launched late-stage critical clinical trials, new preparations for drug registration, and production costs related to pre-commercial activities and supply
                    .
                    In the first quarter of 2021, advances related to research and development of authorized drug candidates were US$85 million, a decrease of US$334.
                    5 million from US$43 million in the same period last year
                    .
                    In the first quarter of 2021, R&D-related equity incentive expenditures were US$22.
                    19 million; compared to US$200.
                    4 million in the same period last year
                  • Sales, general and administrative ( SG&A ) expenses  for the three months ended March 31, 2021.
                    Sales, general and administrative expenses were US$182.
                    1 million; compared to US$107.
                    1 million in the same period last year
                    .
                    The increase in sales, general and administrative expenses is mainly attributable to the increase in the number of employees and the increase in expenses related to the continuous expansion of the global business team as the company builds a global layout
                    .
                    In the first quarter of 2021, sales, general, and administrative related equity incentive expenses were US$233.
                    9 million; compared with US$117.
                    9 million in the same period last year
                  • Net  income for the three months ended March 31, 2021, net income was US$666.
                    5 million, that is, basic and diluted earnings per share were US$0.
                    06 and US$0.
                    05, or American depositary shares (ADS) basic and diluted The subsequent earnings were US$0.
                    73 and US$0.
                    69 respectively; in comparison, the net loss in the same period last year was US$363.
                    7 million, which is US$0.
                    36 per share, or US$4.
                    70 per ADS.
                    

                  Financial summary

                  Brief consolidated balance sheet summary data (US GAAP)

                  (Unit is USD 1000)

                  	As of
                  	2021 Nian		2020 year
                  	3 Yue 31 Ri		12 Yue 31 Ri
                  	(Unaudited)		(Audited)
                  Assets :
                  Cash, cash equivalents, restricted cash and short-term investments	$	4,820,878			$	4,658,730
                  accounts receivable	84,010			60,403
                  Working capital	4,028,437			3,885,491
                  net value of fixed assets	373,949			357,686
                  Total assets	5,821,004			5,600,757
                  Liabilities and owner's equity:
                  accounts payable	146,923			231,957
                  Accrued expenses and other payables	312,134			346,144
                  Deferred income	150,245			—
                  debt	598,062			518,652
                  total liability	1,817,417			1,731,514
                  Total owner's equity	$	4,003,587			$	3,869,243

                   

                  Condensed Consolidated Operating Statement (U.
                  S.
                  Generally Accepted Accounting Principles)

                  (Except for the number of common shares, number of ADSs, common shares per share and ADS per share, the unit is 1,000 US dollars)

                  	As of 3 Yue 31 months of the date
                  	2021		2020
                  	( Unaudited )
                  income:
                  Net product revenue	$	106,117			$	52,059
                  Cooperation income	499,755			—
                  Total revenue	605,872			52,059
                  cost:
                  Product cost of sales	32,685			14,149
                  R&D expenses [1]	320,726			304,302
                  Sales, general and administrative expenses	182,106			107,081
                  Amortization of intangible assets	188			283
                  total cost	535,705			425,815
                  Operating loss	70,167			(373,756)
                  Interest income (expense), net	(4,179)			6,690
                  Other income (expense), net	(4,123)			3,681
                  Pre-tax loss	61,865			(363,385)
                  Income tax (expense) income	(4,630)			1,554
                  Net loss	66,495			(364,939)
                  Less: Net income (loss) attributable to minority shareholders’ equity	—			(1,204)
                  Net loss attributable to BeiGene	$	66,495			$	(363,735)
                  Net loss per share attributable to BeiGene
                  Basic	$	0. 06			$	(0. 36)
                  After dilution	$	0. 05			$	(0. 36)
                  The weighted average number used to calculate the net loss per common share
                  Basic	1,188,943,726			1,005,347,581
                  After dilution	1,257,489,671			1,005,347,581
                  Net loss per ADS attributable to BeiGene
                  Basic	$	0. 73			$	(4. 70)
                  After dilution	$	0. 69			$	(4. 70)
                  ADS weighted average number used to calculate the net loss per ADS
                  Basic	91,457,210			77,334,429
                  After dilution	96,729,975			77,334,429