- \n
- Recorded first quarter product revenue of $410.3 million, increasing 56.9% over $261.6 million from the prior-year period<\/i><\/li>\n<\/ul>\n
- \n
- Launched BRUKINSA\u00ae<\/sup> in the U.S. for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); global BRUKINSA product revenue totaled $211.4 million, more than doubling from first quarter 2022<\/i><\/li>\n<\/ul>\n
- \n
- Continued to build on leading position in China oncology market, supported by success of tislelizumab and BRUKINSA<\/i><\/li>\n<\/ul>\n
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nBeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results for the first quarter 2023, recent business highlights, and upcoming milestones.<\/p>\n\n\u201cOur two cornerstone medicines, BRUKINSA and tislelizumab, achieved significant global growth in the first quarter as we continue to advance our pipeline of innovative therapies for patients with cancer,\u201d said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. \u201cThe strong uptake of BRUKINSA following recent global approvals in CLL speaks to the importance of a BTKi that has demonstrated superior efficacy and safety to IMBRUVICA\u00ae<\/sup>. We are committed to bringing our impactful medicines to more patients around the world.\u201d<\/p>\n
\n\u201cOur first-quarter results demonstrate BeiGene\u2019s progress in operational excellence and financial discipline to bring affordable and accessible medicines to more patients globally,\u201d said Julia Wang, Chief Financial Officer at BeiGene. \u201cWith product revenues continuing to grow meaningfully faster than operational expenses, BeiGene is well positioned for future growth.\u201d<\/p>\n
First Quarter 2023 Financial Results<\/span><\/b><\/p>\n
Revenue<\/b> for the three months ended March 31, 2023, was $447.8 million, compared to $306.6 million in the same period of 2022.<\/p>\n
- \n
- \nProduct revenue totaled $410.3 million for the three months ended March 31, 2023, compared to $261.6 million in the same period of 2022, including:<\/p>\n<\/li>\n<\/ul>\n
\n\u2013 Global sales of BRUKINSA of $211.4 million for the first quarter of 2023, compared to $104.3 million in the prior-year period;<\/p>\n
\n\u2013 Sales of tislelizumab in China of $114.9 million for the first quarter of 2023, compared to $87.6 million in the prior-year period; and<\/p>\n
\n\u2013 Sales of Amgen in-licensed products in China of $36.4 million for the first quarter of 2023, compared to $29.9 million in the prior-year period.<\/p>\n
- \n
- \nCollaboration revenue for the three months ended March 31, 2023, was $37.5 million, resulting from partial recognition of the upfront payments from Novartis related to the tislelizumab and ociperlimab agreements, which were entered into in the first quarter and fourth quarter of 2021, respectively. This compared to $45.1 million in the prior-year period.<\/p>\n<\/li>\n<\/ul>\n
Cost of Product Sales<\/b> for the first quarter of 2023 was $81.8 million, compared to $65.2 million in the prior-year period. Cost of sales increased primarily due to increased product sales of BRUKINSA and tislelizumab, as well as sales of XGEVA\u00ae<\/sup> and POBEVCY\u00ae<\/sup>.<\/p>\n
Gross Margin<\/b> as a percentage of global product sales for the first quarter of 2023 was 80.1%, compared to 75.1% in the prior-year period. The gross margin percentage increased primarily due to lower costs per unit for both BRUKINSA and tislelizumab, as well as a proportionally higher sales mix of global BRUKINSA sales compared to other products in the portfolio and compared to lower-margin sales of in-licensed products.<\/p>\n
Operating Expenses <\/b>for the three months ended March 31, 2023, were $737.3 million, compared to $684.7 million in the same period of 2022.<\/p>\n
- \n
- R&D Expenses<\/b> for the three months ended March 31, 2023, were $408.6 million, compared to $389.9 million in the prior-year period. The increase in R&D expenses was primarily attributable to increases in headcount and costs related to investment in our discovery and development activities, including our continued efforts to internalize clinical operations activities, partially offset by lower fees paid to clinical research organizations for clinical trials. Employee share-based compensation expense was $34.0 million for the first quarter of 2023, compared to $30.9 million in the prior-year period; and\n<\/li>\n<\/ul>\n
- \n
- SG&A Expenses <\/b>for the three months ended March 31, 2023, were $328.5 million, compared to $294.6 million in the prior-year period. The increase in SG&A expenses was primarily attributable to increased headcount, largely related to the expansion of our commercial teams, higher external commercial expenses, including market access and promotional activities. Employee share-based compensation expense was $41.4 million and $34.7 million for the first quarters of 2023 and 2022, respectively.\n<\/li>\n<\/ul>\n
Net Loss <\/b>for the quarter ended March 31, 2023, was $348.4 million, or $0.26 per share, and $3.34 per American Depositary Share (ADS), compared to $435.2 million, or $0.33 per share, and $4.25 per ADS in the same period of 2022. The decrease in net loss is primarily attributable to improved operating leverage due to growing product revenues exceeding operating expense growth. The company expects this trend to continue through 2023.<\/p>\n
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments<\/b> were $3.8 billion as of March 31, 2023, and $4.5 billion as of December 31, 2022.<\/p>\n
- \n
- \nIn the three months ended March 31, 2023, cash used in operating activities was $563.8 million, primarily due to our net loss of $348.4 million and an increase in working capital of $294.1 million due to the seasonality of receivables and compensation-related payments. These were partially offset by non-cash charges within net loss of $78.7 million. Capital expenditures were $125.6 million and cash used in financing activities was $19.9 million;<\/p>\n
In the three months ended March 31, 2022, cash used in operating activities was $236.6 million, primarily due to our net loss of $435.2 million, partially offset by non-cash charges within net loss of $80.9 million. Net operating assets and liabilities contributed $117.7 million of cash due to the collection of the $300 million upfront fee from Novartis for ociperlimab, partially offset by seasonality of working capital due to compensation-related payments. Capital expenditures were $45.1 million, and cash used in financing activities was $11.3 million.<\/p>\n<\/li>\n<\/ul>\n
Recent Business Highlights<\/span><\/b><\/p>\n
Commercial Operations<\/b><\/p>\n
- \n
- \nProduct sales increased 57% in the first quarter of 2023 compared to the prior-year period, primarily due to increased sales of our internally developed products, BRUKINSA and tislelizumab, as well as increased sales of in-licensed products from Amgen and Bio-Thera;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nGlobal sales of BRUKINSA totaled $211.4 million in the first quarter, representing a 103% increase compared to the prior-year period. U.S. sales of BRUKINSA totaled $138.8 million in the first quarter, representing growth of 104% over the prior-year period, driven by the launch for adult patients with CLL\/SLL. BRUKINSA adoption accelerated across all FDA-approved indications, as clinicians expanded use and the prescriber base continued to grow. BRUKINSA sales in China totaled $48.1 million, representing growth of 44% over the prior-year period, driven by increases in all approved indications; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nSales of tislelizumab in China totaled $114.9 million in the first quarter, representing growth of 31% compared to the prior-year period. Continued increase in new patient demand from broader reimbursement and further expansion of our salesforce efficiency and hospital listings continued to drive increased market penetration and market share for tislelizumab.<\/p>\n<\/li>\n<\/ul>\n
Regulatory Progress and Development Programs<\/b><\/p>\n
BRUKINSA<\/i>\u00ae<\/sup> (zanubrutinib)<\/i><\/b>, a small molecule inhibitor of Bruton\u2019s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in more than 65 markets including the U.S., China, European Union, Great Britain, Canada, Australia, South Korea and Switzerland in selected indications and under development for additional approvals globally. The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.<\/i><\/p>\n
- \n
- \nSubmitted a supplemental New Drug Application (sNDA) to the U.S. FDA based on results from a final progression-free survival analysis of the Phase 3 ALPINE trial in adult patients with R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nReceived approval in Australia for the treatment of adult patients with CLL\/SLL;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nReceived acceptance in the European Union for sNDA submissions for R\/R follicular lymphoma (FL) and PFS superiority in R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nSubmitted sNDAs for R\/R FL in Switzerland, the United Kingdom and Canada, under the ACCESS consortium; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nExpanded BRUKINSA’s registration program globally, including potential launches in more than 30 markets in 2023.<\/p>\n<\/li>\n<\/ul>\n
Tislelizumab<\/i><\/b>,<\/i>a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc\u03b3R on macrophages; approved in China in 10 indications and under development for additional approvals globally. The global tislelizumab clinical development program includes more than 12,100 subjects enrolled to date in 31 countries and regions.<\/i><\/p>\n
- \n
- \nPresented results from the RATIONALE-302 (NCT03430843), RATIONALE-304 (NCT03663205), RATIONALE-306 (NCT03783442), RATIONALE-307 (NCT03594747) at the 2023 American Association for Cancer Research (AACR) meeting;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nAnnounced positive Phase 3 trial in advanced gastric or gastroesophageal junction adenocarcinoma; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nU.S. FDA pre-approval manufacturing inspections for tislelizumab biologics license application (BLA) scheduled for Q2.<\/p>\n<\/li>\n<\/ul>\n
Ociperlimab (BGB-A1217)<\/i><\/b>, an investigational anti-TIGIT monoclonal antibody with competent Fc function. The global ociperlimab development program includes 20 countries and regions, and more than 1,700 subjects have been enrolled.<\/i><\/p>\n
- \n
- \nCompleted enrollment in a Phase 2 trial (NCT05014815) in combination with tislelizumab and chemotherapy in first-line non-small cell lung cancer (NSCLC).<\/p>\n<\/li>\n<\/ul>\n
BGB-11417<\/i><\/b>, an investigational, highly selective and highly potent inhibitor of BCL-2, being developed as monotherapy or in combination with zanubrutinib +\/- obinutuzumab in B-cell malignancies, in combination with azacytidine in AML and MDS and as monotherapy and in combination with dexamethasone and in combination with carfilzomib in multiple myeloma. The global BGB-11417 development program includes seven countries and regions, and more than 430 subjects have been enrolled.<\/i><\/p>\n
- \n
- \nContinued to advance development with potentially registration-enabling Phase 2 studies in R\/R mantle cell lymphoma (MCL) (NCT05471843) and R\/R CLL\/SLL (NCT05479994).<\/p>\n<\/li>\n<\/ul>\n
BGB-A445<\/i><\/b>, an investigational non-ligand competing OX40 monoclonal antibody, being developed as monotherapy or in combination with tislelizumab.<\/p>\n
- \n
- \nCompleted enrollment in a Phase 1 dose-escalation trial in combination with tislelizumab in solid tumors (NCT04215978).<\/p>\n<\/li>\n<\/ul>\n
Early-Stage Programs<\/b><\/p>\n
\nContinued to advance our early-stage clinical pipeline of internally developed product candidates at dose-escalation stage, including:<\/p>\n
- \n
- \nBGB-B167: an investigational first-in-class CEA x 4-1BB bispecific antibody, as a monotherapy and in combination with tislelizumab in patients with selected CEA-expressing advanced or metastatic solid tumors, including colorectal cancer (CRC);<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-A425: an investigational anti-TIM-3 antibody, in combination with tislelizumab in patients with head and neck squamous cell carcinoma, NSCLC and renal cell carcinoma;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-15025: an investigational, first-in-class hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-16673: an investigational Chimeric Degradation Activating Compound (CDAC), targeting BTK protein degradation as monotherapy in B cell malignancies;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-24714: an investigational Second Mitochondrial-derived Activator of Caspase, mimetic as monotherapy or in combination with paclitaxel in advanced solid tumors; presented pre-clinical study results at AACR Annual Meeting 2023;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-10188: an investigational PI3K\u03b4 inhibitor as monotherapy or in combination with BRUKINSA in hematologic malignancies, or in combination with tislelizumab in solid tumors; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nBGB-23339: a potent, allosteric investigational tyrosine kinase 2 inhibitor.<\/p>\n<\/li>\n<\/ul>\n
Collaboration Programs<\/b><\/p>\n
- \n
- \nIn collaboration with SpringWorks Therapeutics, presented Phase 1b clinical data for lifirafenib (BGB-283), an investigational B-RAF inhibitor, with SpringWorks\u2019 MEK inhibitor, mirdametinib, in patients with advanced or refractory solid tumors with RAS mutations, RAF mutations and other MAPK pathway aberrations at AACR;
\n<\/li>\n<\/ul>\n- \n
- \nIn collaboration with MapKure and SpringWorks, presented Phase 1a\/b clinical data for brimarafenib (BGB-3245), an investigational, selective RAF dimer inhibitor, in adult patients with advanced or refractory solid tumors harboring MAPK pathway mutations at AACR;
\n<\/li>\n<\/ul>\n- \n
- \nIn collaboration with Leads Biolabs, initiated enrollment for Phase 2 clinical trial of LBL-007, a novel investigational antibody targeting the LAG-3 pathway, in combination with tislelizumab and bevacizumab plus capecitabine in unresectable or metastatic CRC (NCT05609370); and
\n<\/li>\n<\/ul>\n- \n
- \nAlso in collaboration with Leads Biolabs, initiated patient dosing of LBL-007 in combination with tislelizumab, in umbrella studies comparing different tislelizumab combination regimens, including with BGB-A445 and ociperlimab (NCT05635708, NCT05577702).<\/p>\n<\/li>\n<\/ul>\n
Manufacturing Operations<\/b><\/p>\n
- \n
- \nThe final piece of structural steel was placed for the company\u2019s U.S. flagship manufacturing and clinical R&D facility under construction at the Princeton West Innovation Campus in Hopewell, N.J. The property has more than one million square feet total of developable real estate, allowing for future expansion;<\/p>\n<\/li>\n
- \nContinued construction on our state-of-the-art biologics facility in Guangzhou, China, which has a current total capacity of 54,000 liters, with an expansion of 10,000 liters expected in the second quarter of 2023;<\/p>\n<\/li>\n
- \nStarted construction of an antibody drug conjugate (ADC) production facility and additional biologics clinical production building in Guangzhou, to be completed in 2024; and started construction of a new R&D center in Suzhou, China, that will improve both clinical and manufacturing capabilities, to be completed in 2025; and<\/p>\n<\/li>\n
- \nContinued construction on our new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction is expected to add more than 559,000 square feet and expand production capacity to 600 million tablets\/capsules, and to be completed in 2023. Once completed, qualified and approved, it is expected to increase the total small molecule manufacturing capacity in China by up to 10 times current capacity.<\/p>\n<\/li>\n<\/ul>\n
Corporate Developments<\/b><\/p>\n
- \n
- \nAnnounced the formal opening of a corporate office in Sao Paulo, Brazil, as part of broader expansion plans in Latin America.<\/p>\n<\/li>\n<\/ul>\n
Expected Milestones<\/b><\/p>\n
BRUKINSA<\/i><\/b><\/p>\n
- \n
- \nContinue to support U.S. FDA and European Medicines Agency (EMA) review of sNDA for PFS superiority in R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nContinue to support National Medical Products Administration review of sNDA for first-line CLL\/SLL and WM in China, with a decision expected in the first half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nContinue to support Health Canada review of sNDA for CLL, with decision expected in 2023;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nContinue to expand BRUKINSA\u2019s registration program globally in new geographies and indications; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nPresentation of results from the first interim analysis of a Phase 1 study of zanubrutinib plus lenalidomide in patients with R\/R diffuse large B-cell lymphoma at the ASCO 2023 Annual Meeting, as well as abstract for updated analysis of the ROSEWOOD study of zanubrutinib plus obinutuzumab versus obinutuzumab in patients with relapsed\/refractory follicular lymphoma.<\/p>\n<\/li>\n<\/ul>\n
Tislelizumab<\/i><\/b><\/p>\n
- \n
- \nContinue to support NMPA review of BLA applications for tislelizumab in combination with chemotherapy as a first-line treatment in patients with unresectable locally advanced, recurrent or metastatic ESCC, with a decision expected in the first half of 2023; and for tislelizumab as a treatment for first-line hepatocellular carcinoma, with a decision expected in the second half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nContinue to support review by regulatory authorities of BeiGene’s applications for tislelizumab, including:<\/p>\n<\/li>\n<\/ul>\n
\n\u2013 Australia\u2019s TGA review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in the second half of 2023, as well as New Zealand’s Medsafe review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC; and<\/p>\n
\n\u2013 South Korea Ministry of Food and Drug Safety review of BLA for tislelizumab in second-line ESCC; and<\/p>\n
\n\u2013 Brazil\u2019s Anvisa review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC;<\/p>\n
- \n
- \nIn collaboration with Novartis, continue to support review of marketing applications, including:<\/p>\n<\/li>\n<\/ul>\n
\n\u2013 Ongoing U.S. FDA review of the BLA submission in second-line ESCC, with a decision expected in 2023;<\/p>\n
\n\u2013 EMA review of marketing authorization applications for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in 2023;<\/p>\n
\n\u2013 Medicines and Healthcare products Regulatory Agency review of tislelizumab for treatment of first- and second-line NSCLC and second-line ESCC in Great Britain;<\/p>\n
\n\u2013 Swissmedic review of marketing authorization applications for tislelizumab in second-line ESCC and second-line NSCLC;<\/p>\n
\n\u2013 Support U.S. FDA regulatory submission by Novartis in 2023 for first-line gastric cancer and first-line unresectable ESCC; and<\/p>\n
\n\u2013 Submit BLA to Japan\u2019s Pharmaceutical and Medical Devices Agency in 2023 for first- and second-line ESCC.<\/p>\n
- \n
- \nAnnounce final analysis data from pivotal trials in extensive-stage small cell lung cancer in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nTwo abstracts for additional analyses of RATIONALE 301 accepted for poster presentation at 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
BGB-11417 (BCL-2 inhibitor)<\/i><\/b><\/p>\n
- \n
- \nInitiate global pivotal trial in first-line CLL in combination with BRUKINSA in the second half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nAnnounce readouts from ongoing studies; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nAbstract for a Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity BGB-11417 in adult patients with mature B-cell malignancies accepted for poster presentation at 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
Ociperlimab (anti-TIGIT)<\/i><\/b><\/p>\n
- \n
- \nAnnounce readouts for multiple Phase 2 studies in 2023, including:<\/p>\n<\/li>\n<\/ul>\n
\n\u2013 For second-line ESCC in patients whose tumors express PD-(L)1 (NCT04732494);<\/p>\n
\n\u2013 For first-line hepatocellular carcinoma (NCT04948697); and<\/p>\n
\n\u2013 For first-line NSCLC (NCT05014815).<\/p>\n
- \n
- \nComplete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nAbstract for Phase 1b AdvanTIG-105 study accepted for poster presentation at ASCO 2023 Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
BGB-16673 (BTK CDAC)<\/i><\/b><\/p>\n
- \n
- \nInitial data readouts for Phase 1 studies in B cell malignancies (NCT05006716, NCT05294731) in 2023.<\/p>\n<\/li>\n<\/ul>\n
BGB-A445 (anti-OX 40)<\/i><\/b><\/p>\n
- \n
- \nInitial data readout for Phase 1 study in solid tumors (NCT04215978) in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nAbstract for a Phase 1 study of the OX40 agonist, BGB-A445, with or without tislelizumab in patients with advanced solid tumors accepted for poster presentation at the 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
BGB-15025 (HPK 1)<\/i><\/b><\/p>\n
- \n
- \nInitiate dose expansion in combination with tislelizumab in solid tumors (NCT04649385) in 2023.<\/p>\n<\/li>\n<\/ul>\n
Collaboration Programs<\/i><\/b><\/p>\n
- \n
- \nAbstract for updated results from a Phase 1b\/2 study of zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer accepted for poster presentation at 2023 ASCO Annual Meeting, as well as an abstract for the pivotal Phase 2b HERIZON-BTC-01 study with zanidatamab in previously treated HER2 amplified Biliary Tract Cancer accepted for oral presentation.<\/p>\n<\/li>\n<\/ul>\n
COVID-19 Impact and Response<\/b><\/p>\n
\nWe are continuing to monitor the impact of the effects of the COVID-19 pandemic on our business. It is possible that the COVID-19 pandemic continues to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts. We are striving to minimize delays and disruptions, have put protocols and procedures in place, and continue to execute on our commercial, regulatory, manufacturing, and clinical development goals globally.<\/p>\n
Financial Summary<\/span><\/b><\/p>\n
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)<\/b><\/p>\n
\n(Amounts in thousands of U.S. Dollars)<\/p>\n
\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n As of<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n March 31,<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2022<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(unaudited)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(audited)<\/p>\n<\/td>\n<\/tr>\n
\n \n Assets:<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nCash, cash equivalents, restricted cash and short-term investments<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n3,837,823<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n4,540,288<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAccounts receivable, net<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n309,628<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n173,168<\/p>\n<\/td>\n<\/tr>\n
\n \n \nInventories<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n296,995<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n282,346<\/p>\n<\/td>\n<\/tr>\n
\n \n \nProperty and equipment, net<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n925,404<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n845,946<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal assets<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n5,956,775<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n6,379,290<\/p>\n<\/td>\n<\/tr>\n
\n \n Liabilities and equity:<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAccounts payable<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n241,360<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n294,781<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAccrued expenses and other payables<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n417,922<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n467,352<\/p>\n<\/td>\n<\/tr>\n
\n \n \nDeferred revenue<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n222,822<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n255,887<\/p>\n<\/td>\n<\/tr>\n
\n \n \nR&D cost share liability<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n276,562<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n293,960<\/p>\n<\/td>\n<\/tr>\n
\n \n \nDebt<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n488,106<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n538,117<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal liabilities<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n1,799,469<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n1,995,935<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal equity<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n4,157,306<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n4,383,355<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
Condensed Consolidated Statements of Operations (U.S. GAAP)<\/b><\/p>\n
\n(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)<\/p>\n
\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n Three Months Ended<\/b><\/p>\n
March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2023<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n 2022 1<\/sup><\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n (Unaudited)<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \nRevenue:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nProduct revenue, net<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n410,291<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n261,573<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nCollaboration revenue<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n37,510<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n45,053<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal revenues<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n447,801<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n306,626<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nExpenses:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nCost of sales – products<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n81,789<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n65,237<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nResearch and development<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n408,584<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n389,915<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nSelling, general and administrative<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n328,499<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n294,573<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nAmortization of intangible assets<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n187<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n188<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal expenses<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n819,059<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n749,913<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLoss from operations<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(371,258<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(443,287<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nInterest income (expense), net<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n16,016<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n10,071<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nOther (loss) income, net<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n18,303<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11,967<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLoss before income taxes<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(336,939<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(421,249<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nIncome tax expense<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n11,492<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n13,949<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet loss<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(348,431<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n(435,198<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet loss per share attributable to BeiGene, Ltd.:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nBasic and diluted<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.26<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(0.33<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nWeighted-average shares outstanding:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nBasic and diluted<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n1,354,164,760<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n1,332,017,262<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nNet loss per ADS attributable to BeiGene, Ltd.:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nBasic and diluted<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(3.34<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n(4.25<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n<\/tr>\n
\n \n \nWeighted-average ADSs outstanding:<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nBasic and diluted<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n104,166,520<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n102,462,866<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
1<\/sup> We revised certain prior period financial statements for an error related to the valuation of net deferred tax assets, the impact of which was immaterial to our previously filed financial statements in the first quarter of 2022 (see “Notes to the Condensed Consolidated Financial Statements, Note 1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies” and “Note 2. Revision of Prior Period Financial Statements” included in our Quarterly Report on Form 10-Q for the period ended March 31, 2023 filed with the SEC).<\/p>\n
About BeiGene<\/b><\/p>\n
\nBeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,400 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com<\/a> and follow us on Twitter at @BeiGeneGlobal.<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
\nThis 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 clinical data for BeiGene\u2019s drug candidates and approvals of its medicines; the conduct of late-stage clinical trials and expected data readouts; additional planned product approvals and launches; the advancement of and anticipated clinical development, regulatory approvals and other milestones and commercialization of BeiGene\u2019s medicines and drug candidates; the expected future growth of BeiGene, including expansion in Latin America; the potential for BRUKINSA to provide clinical benefit to patients including superior efficacy and safety compared with the comparator drug; the future success of BeiGene\u2019s commercialization efforts and product revenue growth; the expected decrease in BeiGene\u2019s future operational expenses; the expected capacities and completion dates for the Company’s manufacturing facilities under construction and the potential for such facilities to improve clinical and manufacturing capabilities; the impact of the COVID-19 pandemic on the Company\u2019s clinical development, regulatory, commercial, manufacturing, and other operations; BeiGene\u2019s plans and the expected events and milestones under the captions \u201cRecent Business Highlights\u201d and \u201cExpected Milestones\u201d; and BeiGene’s plans, commitments, aspirations and goals under the caption \u201cAbout BeiGene\u201d. 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 medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled \u201cRisk Factors\u201d in BeiGene\u2019s most recent annual report on Form 10-K, 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.<\/p>\n
\nBLINCYTO\u00ae<\/sup>, KYPROLIS\u00ae<\/sup> and XGEVA\u00ae<\/sup> are registered trademarks of Amgen or its subsidiaries<\/p>\n
\nPOBEVCY\u00ae<\/sup> is a registered trademark of Bio-Thera Solutions, Ltd.<\/p>\n
\nIMBRUVICA\u00ae<\/sup> is a registered trademark of Pharmacyclics LLC and Janssen Biotech, Inc.<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230504005408\/en\/<\/a><\/span><\/p>\n
Investor
\n
<\/b>Kevin Mannix
\n
+1 857-302-5189
\n
ir@beigene.com<\/a><\/p>\nMedia
\n
<\/b>Kyle Blankenship
\n
+1 667-351-5176
\n
media@beigene.com<\/a><\/p>\nKEYWORDS:<\/b> Massachusetts Switzerland China United States North America Asia Pacific Europe<\/p>\n
INDUSTRY KEYWORDS:<\/b> Biotechnology General Health Pharmaceutical Health<\/p>\n
MEDIA:<\/b><\/p>\n
\n
\n
- \nAbstract for updated results from a Phase 1b\/2 study of zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer accepted for poster presentation at 2023 ASCO Annual Meeting, as well as an abstract for the pivotal Phase 2b HERIZON-BTC-01 study with zanidatamab in previously treated HER2 amplified Biliary Tract Cancer accepted for oral presentation.<\/p>\n<\/li>\n<\/ul>\n
- \nInitiate dose expansion in combination with tislelizumab in solid tumors (NCT04649385) in 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nAbstract for a Phase 1 study of the OX40 agonist, BGB-A445, with or without tislelizumab in patients with advanced solid tumors accepted for poster presentation at the 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
- \nInitial data readout for Phase 1 study in solid tumors (NCT04215978) in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \nInitial data readouts for Phase 1 studies in B cell malignancies (NCT05006716, NCT05294731) in 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nAbstract for Phase 1b AdvanTIG-105 study accepted for poster presentation at ASCO 2023 Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
- \nComplete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \nAnnounce readouts for multiple Phase 2 studies in 2023, including:<\/p>\n<\/li>\n<\/ul>\n
- \nAbstract for a Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity BGB-11417 in adult patients with mature B-cell malignancies accepted for poster presentation at 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
- \nAnnounce readouts from ongoing studies; and<\/p>\n<\/li>\n<\/ul>\n
- \nInitiate global pivotal trial in first-line CLL in combination with BRUKINSA in the second half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \nTwo abstracts for additional analyses of RATIONALE 301 accepted for poster presentation at 2023 ASCO Annual Meeting.<\/p>\n<\/li>\n<\/ul>\n
- \nAnnounce final analysis data from pivotal trials in extensive-stage small cell lung cancer in 2023; and<\/p>\n<\/li>\n<\/ul>\n
- \nIn collaboration with Novartis, continue to support review of marketing applications, including:<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to support review by regulatory authorities of BeiGene’s applications for tislelizumab, including:<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to support NMPA review of BLA applications for tislelizumab in combination with chemotherapy as a first-line treatment in patients with unresectable locally advanced, recurrent or metastatic ESCC, with a decision expected in the first half of 2023; and for tislelizumab as a treatment for first-line hepatocellular carcinoma, with a decision expected in the second half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \nPresentation of results from the first interim analysis of a Phase 1 study of zanubrutinib plus lenalidomide in patients with R\/R diffuse large B-cell lymphoma at the ASCO 2023 Annual Meeting, as well as abstract for updated analysis of the ROSEWOOD study of zanubrutinib plus obinutuzumab versus obinutuzumab in patients with relapsed\/refractory follicular lymphoma.<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to expand BRUKINSA\u2019s registration program globally in new geographies and indications; and<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to support Health Canada review of sNDA for CLL, with decision expected in 2023;<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to support National Medical Products Administration review of sNDA for first-line CLL\/SLL and WM in China, with a decision expected in the first half of 2023;<\/p>\n<\/li>\n<\/ul>\n
- \nContinue to support U.S. FDA and European Medicines Agency (EMA) review of sNDA for PFS superiority in R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \nAnnounced the formal opening of a corporate office in Sao Paulo, Brazil, as part of broader expansion plans in Latin America.<\/p>\n<\/li>\n<\/ul>\n
- \nAlso in collaboration with Leads Biolabs, initiated patient dosing of LBL-007 in combination with tislelizumab, in umbrella studies comparing different tislelizumab combination regimens, including with BGB-A445 and ociperlimab (NCT05635708, NCT05577702).<\/p>\n<\/li>\n<\/ul>\n
- \nIn collaboration with Leads Biolabs, initiated enrollment for Phase 2 clinical trial of LBL-007, a novel investigational antibody targeting the LAG-3 pathway, in combination with tislelizumab and bevacizumab plus capecitabine in unresectable or metastatic CRC (NCT05609370); and
- \nIn collaboration with MapKure and SpringWorks, presented Phase 1a\/b clinical data for brimarafenib (BGB-3245), an investigational, selective RAF dimer inhibitor, in adult patients with advanced or refractory solid tumors harboring MAPK pathway mutations at AACR;
- \nIn collaboration with SpringWorks Therapeutics, presented Phase 1b clinical data for lifirafenib (BGB-283), an investigational B-RAF inhibitor, with SpringWorks\u2019 MEK inhibitor, mirdametinib, in patients with advanced or refractory solid tumors with RAS mutations, RAF mutations and other MAPK pathway aberrations at AACR;
- \nBGB-23339: a potent, allosteric investigational tyrosine kinase 2 inhibitor.<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-10188: an investigational PI3K\u03b4 inhibitor as monotherapy or in combination with BRUKINSA in hematologic malignancies, or in combination with tislelizumab in solid tumors; and<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-24714: an investigational Second Mitochondrial-derived Activator of Caspase, mimetic as monotherapy or in combination with paclitaxel in advanced solid tumors; presented pre-clinical study results at AACR Annual Meeting 2023;<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-16673: an investigational Chimeric Degradation Activating Compound (CDAC), targeting BTK protein degradation as monotherapy in B cell malignancies;<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-15025: an investigational, first-in-class hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors;<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-A425: an investigational anti-TIM-3 antibody, in combination with tislelizumab in patients with head and neck squamous cell carcinoma, NSCLC and renal cell carcinoma;<\/p>\n<\/li>\n<\/ul>\n
- \nBGB-B167: an investigational first-in-class CEA x 4-1BB bispecific antibody, as a monotherapy and in combination with tislelizumab in patients with selected CEA-expressing advanced or metastatic solid tumors, including colorectal cancer (CRC);<\/p>\n<\/li>\n<\/ul>\n
- \nCompleted enrollment in a Phase 1 dose-escalation trial in combination with tislelizumab in solid tumors (NCT04215978).<\/p>\n<\/li>\n<\/ul>\n
- \nContinued to advance development with potentially registration-enabling Phase 2 studies in R\/R mantle cell lymphoma (MCL) (NCT05471843) and R\/R CLL\/SLL (NCT05479994).<\/p>\n<\/li>\n<\/ul>\n
- \nCompleted enrollment in a Phase 2 trial (NCT05014815) in combination with tislelizumab and chemotherapy in first-line non-small cell lung cancer (NSCLC).<\/p>\n<\/li>\n<\/ul>\n
- \nU.S. FDA pre-approval manufacturing inspections for tislelizumab biologics license application (BLA) scheduled for Q2.<\/p>\n<\/li>\n<\/ul>\n
- \nAnnounced positive Phase 3 trial in advanced gastric or gastroesophageal junction adenocarcinoma; and<\/p>\n<\/li>\n<\/ul>\n
- \nPresented results from the RATIONALE-302 (NCT03430843), RATIONALE-304 (NCT03663205), RATIONALE-306 (NCT03783442), RATIONALE-307 (NCT03594747) at the 2023 American Association for Cancer Research (AACR) meeting;<\/p>\n<\/li>\n<\/ul>\n
- \nExpanded BRUKINSA’s registration program globally, including potential launches in more than 30 markets in 2023.<\/p>\n<\/li>\n<\/ul>\n
- \nSubmitted sNDAs for R\/R FL in Switzerland, the United Kingdom and Canada, under the ACCESS consortium; and<\/p>\n<\/li>\n<\/ul>\n
- \nReceived acceptance in the European Union for sNDA submissions for R\/R follicular lymphoma (FL) and PFS superiority in R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \nReceived approval in Australia for the treatment of adult patients with CLL\/SLL;<\/p>\n<\/li>\n<\/ul>\n
- \nSubmitted a supplemental New Drug Application (sNDA) to the U.S. FDA based on results from a final progression-free survival analysis of the Phase 3 ALPINE trial in adult patients with R\/R CLL;<\/p>\n<\/li>\n<\/ul>\n
- \nSales of tislelizumab in China totaled $114.9 million in the first quarter, representing growth of 31% compared to the prior-year period. Continued increase in new patient demand from broader reimbursement and further expansion of our salesforce efficiency and hospital listings continued to drive increased market penetration and market share for tislelizumab.<\/p>\n<\/li>\n<\/ul>\n
- \nGlobal sales of BRUKINSA totaled $211.4 million in the first quarter, representing a 103% increase compared to the prior-year period. U.S. sales of BRUKINSA totaled $138.8 million in the first quarter, representing growth of 104% over the prior-year period, driven by the launch for adult patients with CLL\/SLL. BRUKINSA adoption accelerated across all FDA-approved indications, as clinicians expanded use and the prescriber base continued to grow. BRUKINSA sales in China totaled $48.1 million, representing growth of 44% over the prior-year period, driven by increases in all approved indications; and<\/p>\n<\/li>\n<\/ul>\n
- \nProduct sales increased 57% in the first quarter of 2023 compared to the prior-year period, primarily due to increased sales of our internally developed products, BRUKINSA and tislelizumab, as well as increased sales of in-licensed products from Amgen and Bio-Thera;<\/p>\n<\/li>\n<\/ul>\n
- \nIn the three months ended March 31, 2023, cash used in operating activities was $563.8 million, primarily due to our net loss of $348.4 million and an increase in working capital of $294.1 million due to the seasonality of receivables and compensation-related payments. These were partially offset by non-cash charges within net loss of $78.7 million. Capital expenditures were $125.6 million and cash used in financing activities was $19.9 million;<\/p>\n
- SG&A Expenses <\/b>for the three months ended March 31, 2023, were $328.5 million, compared to $294.6 million in the prior-year period. The increase in SG&A expenses was primarily attributable to increased headcount, largely related to the expansion of our commercial teams, higher external commercial expenses, including market access and promotional activities. Employee share-based compensation expense was $41.4 million and $34.7 million for the first quarters of 2023 and 2022, respectively.\n<\/li>\n<\/ul>\n
- R&D Expenses<\/b> for the three months ended March 31, 2023, were $408.6 million, compared to $389.9 million in the prior-year period. The increase in R&D expenses was primarily attributable to increases in headcount and costs related to investment in our discovery and development activities, including our continued efforts to internalize clinical operations activities, partially offset by lower fees paid to clinical research organizations for clinical trials. Employee share-based compensation expense was $34.0 million for the first quarter of 2023, compared to $30.9 million in the prior-year period; and\n<\/li>\n<\/ul>\n
- \nCollaboration revenue for the three months ended March 31, 2023, was $37.5 million, resulting from partial recognition of the upfront payments from Novartis related to the tislelizumab and ociperlimab agreements, which were entered into in the first quarter and fourth quarter of 2021, respectively. This compared to $45.1 million in the prior-year period.<\/p>\n<\/li>\n<\/ul>\n
- \nProduct revenue totaled $410.3 million for the three months ended March 31, 2023, compared to $261.6 million in the same period of 2022, including:<\/p>\n<\/li>\n<\/ul>\n
- Continued to build on leading position in China oncology market, supported by success of tislelizumab and BRUKINSA<\/i><\/li>\n<\/ul>\n
- Launched BRUKINSA\u00ae<\/sup> in the U.S. for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); global BRUKINSA product revenue totaled $211.4 million, more than doubling from first quarter 2022<\/i><\/li>\n<\/ul>\n