Ociperlimab

Multiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR. “Our presentations at this year’s AACR showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation.” BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors. BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH 2023, demonstrating clinical responses and a tolerable safety pro heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716).​ An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904). BeiGene Presentations During AACR 2024 Abstract Title Abstract # Presentation Time (PDT) Lead Author Preclinical Characterization of the correlation between BTK degradation and tumor growth inhibition of the BTK target protein degraders using PK/PD modeling 2110 Monday, April 8 9 a.m. – 12:30 p.m. Section 30 Board #1 Y. Wu BGB-B167, a first-in-class 4-1BB/CEACAM5 bispecific antibody, exhibits potent in vitro and in vivo anti-tumor activity and superior safety pro > in preclinical models 2371 Monday, April 8 9 a.m. – 12:30 p.m. Section 38 Board #17 Z. Li Translational assessment of triple combination with tislelizumab (anti-PD-1), LBL-007 (anti-LAG- 3) and surzebiclimab (anti-TIM-3) highlights its strong anti-tumor activity and clinical potential in solid tumors such as HNSCC 4041 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 3 Board #17 H. Zhu Clinical Exploration of potential biomarkers correlated with efficacy of ociperlimab (anti-TIGIT) plus tislelizumab (anti-PD1) in 1L PD-L1+ non-small cell lung cancer (NSCLC) CT053 Monday, April 8 9 a.m. – 12:30 p.m. Section 48 Board #3 S. Kim A first in human, phase 1a, dose escalation study of BGB 10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1) in patients with solid tumors CT189 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 48 Board #17 R. Cosman AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC) CT255 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 48 Board #14 Y. Gong BGB-A317-LBL-007-202 (NCT06010303): A phase 2, randomized, active-controlled, open- label study to evaluate the efficacy and safety of LBL 007 (anti-LAG-3) in combination with tislelizumab (TIS; anti-PD-1) plus chemotherapy (chemo) as first-line (1L) treatment in patients with unresectable locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) CT274 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #4 S. Park Liberty-201 (NCT05609370): Maintenance fluoropyrimidine and bevacizumab with or without anti-lymphocyte activation gene-3 (LAG-3) antibody LBL-007 plus anti-programmed cell death protein-1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR)colorectal cancer (CRC) CT276 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #6 H.-J. Lenz BGB-LC-201 (NCT05635708): A phase 2, open- label, multi-arm study of tislelizumab (TIS; anti- PD-1) in combination with investigational agents +/- chemotherapy as first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) CT277 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #7 G. Blumenschein About Tislelizumab Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD‑1) monoclonal antibody with high affinity and binding specificity against PD‑1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative 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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter). Forward-Looking Statements This 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 BeiGene’s ability to discover innovative new medicines for cancer patients and pioneer novel mechanisms; the future development, regulatory filing and approval, and commercialization of tislelizumab, BGB-16673, and other novel molecules; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” 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’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s 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 “Risk Factors” in BeiGene’s 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. View source version on businesswire.com: Contacts Investor: Liza Heapes +1 857-302-5663 ir@beigene.com Media: Kyle Blankenship +1 667-351-5176 media@beigene.com Source: BeiGene, Ltd. View this news release online at:

Continued rapid global growth with record total revenues of $634 million in fourth quarter and $2.5 billion in full-year 2023, increases of 67% and 74% from the prior-year periods Strengthened leadership in hematology with global BRUKINSA® (zanubrutinib) sales of $413 million and $1.3 billion for the quarter and full year, increases of 135% and 129% Progressed innovative hematology pipeline with initiation of four registrational trials for sonrotoclax, including global Phase 3 study in treatment-naïve CLL, and two global expansion cohorts for BTK CDAC in R/R CLL, R/R MCL Sustained growth with diverse product and geographic revenue mix and improved operating leverage BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights. This press release features multimedia. View the full release here: “BeiGene made great progress in the fourth quarter and full year 2023 toward our goal to become an impactful next-generation oncology innovator. We have solidified our leadership in hematology with the continued success of BRUKINSA’s global launch, led by U.S. and Europe,” said John V. Oyler, Chairman, Co-Founder and CEO at BeiGene. “Our cost advantaged research and development and manufacturing have enabled us to build one of the largest and most exciting oncology pipelines in the industry. We look forward to a transformative year for BeiGene as we continue to deliver on operational excellence propelled by outstanding growth in revenue across new and existing geographies.” Key Business and Pipeline Highlights Product revenues for the quarter, $630.5 million, and full year, $2.2 billion, increased 86% and 75% from prior-year totals; Disciplined management of operating expense growth drove operating loss decreases of 18% and 33% on a GAAP basis and 28% and 47% on an adjusted basis for the quarter and full year; Solidified BRUKINSA’s position as a BTK inhibitor of choice with U.S. Food and Drug Administration (FDA) approval of a label update to include superior progression-free survival (PFS) results at a median follow up of 29.6 months from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL); Expanded global label for BRUKINSA with European Commission approval for the treatment of adult patients with R/R follicular lymphoma (FL) who have received at least two prior systematic treatments, making it the first BTK inhibitor ever approved in this indication and the BTK inhibitor with the broadest label in the class; Demonstrated leadership in hematology and strength of the Company’s pipeline with 25 abstracts presented at the American Society of Hematology (ASH) Annual Meeting in December, including: Updated results from the ALPINE trial demonstrating sustained PFS superiority at a median follow up of 39 months for BRUKINSA against IMBRUVICA for the treatment of adult patients with R/R CLL; Phase 1/2 trial data for sonrotoclax demonstrating safety and tolerability in combination with BRUKINSA with deep and durable responses in treatment-naïve CLL; promising single-agent activity in patients with R/R marginal zone lymphoma; and promising efficacy and safety in combination with dexamethasone in multiple myeloma (MM) with t(11,14); and First-in-human data for BTK CDAC BGB-16673 demonstrating notable clinical responses and a tolerable safety pro heavily pretreated patients with B-cell malignancies, including those with BTKi-resistant disease. Expanded the global impact of anti-PD-1 antibody TEVIMBRA® (tislelizumab) with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval as a treatment for non-small cell lung cancer (NSCLC) across three indications, EMA acceptance of submission for the treatment of adult patients with first-line esophageal squamous cell carcinoma (ESCC), and regulatory reviews ongoing in 10 markets, including the U.S. and Europe; and Advanced innovative R&D strategy by entering five New Molecular Entities (NMEs) into the clinic in 2023, including potential best-in-class CDK4 inhibitor BGB-43395. Fourth Quarter and Full Year 2023 Financial Highlights Revenue for the fourth quarter and full year 2023 was $634.4 million and $2.5 billion, respectively, compared to $380.1 million and $1.4 billion in the prior-year periods. The increase in total revenue in the quarter compared to the prior year is primarily attributable to product sales growth in the Company’s major markets. For the fourth quarter and full year 2023, the U.S. was the largest market the Company derived revenue from, with revenue of $313.2 million and $1.1 billion, respectively, compared to $155.4 million and $502.6 million in the prior-year periods. The Company expects this trend to continue in 2024 as U.S. sales of BRUKINSA continue to grow. Three Months Ended December 31, Twelve Months Ended December 31, (in thousands, except per share amounts) 2023 2022 2023 2022 Net product revenues $ 630,526 $ 339,022 $ 2,189,852 $ 1,254,612 Net revenue from collaborations $ 3,883 $ 41,073 $ 268,927 $ 161,309 Total Revenue $ 634,409 $ 380,095 $ 2,458,779 $ 1,415,921 GAAP loss from operations $ (383,795) $ (468,622) $ (1,207,736) $ (1,789,665) Adjusted loss from operations* $ (267,224) $ (372,480) $ (752,473) $ (1,420,225) * For an explanation of our use of non-GAAP financial measures, refer to the "Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release. Product Revenue totaled $630.5 million and $2.2 billion for the fourth quarter and full year 2023, respectively, compared to $339.0 million and $1.3 billion in the prior-year periods, and include: Global sales of BRUKINSA of $413.0 million and $1.3 billion for the fourth quarter and full year 2023, respectively, compared to $176.1 million and $564.7 million in the prior-year periods; Sales of tislelizumab of $128.0 million and $536.6 million for the fourth quarter and full year 2023, respectively, compared to $102.2 million and $422.9 million in the prior-year periods; Sales of Amgen in-licensed products of $51.1 million and $188.3 million for the fourth quarter and full year 2023, respectively, compared to $27.7 million and $114.6 million in the prior-year periods. Gross Margin as a percentage of global product sales for the fourth quarter and full year 2023 was 83.2% and 82.7%, respectively, compared to 78.3% and 77.2% in the prior-year periods. The gross margin percentage increased in both the quarter-over-quarter and year-over-year period due to a proportionally higher product sales mix of global BRUKINSA compared to other products in our portfolio and compared to lower margin in-licensed products, as well as lower costs per unit for both BRUKINSA and tislelizumab. Operating Expenses The following table summarizes operating expenses for the fourth quarter 2023 and 2022, respectively: GAAP Non-GAAP (in thousands, except percentages) Q4 2023 Q4 2022 % Change Q4 2023 Q4 2022 % Change Research and development $ 493,987 $ 446,023 11 % $ 437,383 $ 404,186 8% Selling, general and administrative $ 416,547 $ 328,984 27 % $ 361,435 $ 275,648 31% Amortization(1) $ 1,838 $ 188 878 % $ — $ — NM Total operating expenses $ 912,372 $ 775,195 18 % $ 798,818 $ 679,834 18% The following table summarizes operating expenses for the full year 2023 and 2022, respectively: GAAP Non-GAAP (in thousands, except percentages) FY 2023 FY 2022 % Change FY 2023 FY 2022 % Change Research and development $ 1,778,594 $ 1,640,508 8% $ 1,558,960 $ 1,474,919 6% Selling, general and administrative $ 1,504,501 $ 1,277,852 18% $ 1,284,689 $ 1,077,977 19% Amortization(1) $ 3,500 $ 751 366% $ — $ — NM Total operating expenses $ 3,286,595 $ 2,919,111 13% $ 2,843,649 $ 2,552,896 11% (1) Relates to BMS product distribution rights intangible asset that was fully amortized as of December 31, 2023, when the rights reverted back to BMS under the terms of the Settlement Agreement. Research and Development (R&D) Expenses increased for the fourth quarter and full year 2023 compared to the prior-year periods on both a GAAP and adjusted basis primarily due to investing in new platforms/modalities to advance preclinical programs into the clinic and early clinical programs into late stage. Upfront fees related to in-process R&D for in-licensed assets totaled $31.8 million and $46.8 million in the fourth quarter and full year 2023, respectively, compared to $48.7 million and $68.7 million in the prior-year periods. Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year 2023 compared to the prior-year periods on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA primarily in the U.S. and Europe. Net Loss GAAP net loss improved for the fourth quarter and full year 2023, as compared to the prior-year periods, primarily attributable to reduced operating losses and the non-operating gain of $362.9 million related to the BMS arbitration settlement for full year 2023. For the fourth quarter of 2023, net loss per share was $0.27 per share and $3.53 per ADS, compared to $0.33 per share and $4.29 per ADS in the prior-year period. Net loss for full year 2023 was $0.65 per share and $8.45 per ADS, compared to $1.49 per share and $19.43 per ADS in the prior-year period. Cash, Cash Equivalents, and Restricted Cash Year Ended December 31, 2023 2022 (in thousands) Cash, cash equivalents and restricted cash at beginning of period $ 3,875,037 $ 4,382,887 Net cash used in operating activities (1,157,453) (1,496,619) Net cash provided by investing activities 60,004 1,077,123 Net cash provided by (used in) financing activities 416,478 (18,971) Net effect of foreign exchange rate changes (8,082) (69,383) Net decrease in cash, cash equivalents and restricted cash (689,053) (507,850) Cash, cash equivalents and restricted cash at end of period $ 3,185,984 $ 3,875,037 Cash Used in Operations in fourth quarter and full year 2023 was $221.6 million and $1.2 billion, respectively, compared to $318.2 million and $1.5 billion in the prior-year periods, driven by improved operating leverage. For further details on BeiGene’s 2023 Financial Statements, please see BeiGene’s Annual Report on Form 10-K for the year of 2023 filed with the U.S. Securities and Exchange Commission. Regulatory Progress and Development Programs Key Highlights Solidified BRUKINSA as a BTK inhibitor of choice with PFS superiority label update from the FDA, approvals in R/R FL in Europe and Canada Expanded TEVIMBRA global reach with pending regulatory submissions in 10 markets, including the U.S. and Europe Enrolled first patients in a Phase 3 global trial of sonrotoclax in first-line CLL and expansion cohorts with registration potential for BTK CDAC Category Asset Recent Milestones Regulatory Approvals BRUKINSA Received FDA approved label update to include superior PFS results in adult patients with R/R CLL/SLL based on results from the Phase 3 ALPINE trial Received approval from European Commission and authorization from Health Canada for the treatment of adult patients with R/R FL in combination with obinutuzumab who have received at least two prior lines of systemic therapy Received regulatory approval in four additional markets for R/R and treatment-naïve (TN) CLL TEVIMBRA Received China National Medicinal Products Administration (NMPA) approval as first-line treatment in patients with unresectable hepatocellular carcinoma Received approval from the UK Medicines and Healthcare Regulatory Agency (MHRA) as second-line treatment in patients with advanced ESCC Regulatory Submissions Tislelizumab Received a positive opinion from the CHMP of the EMA recommending approval as a treatment for NSCLC across three indications Received NMPA acceptance of a supplemental Biologics License Application (sBLA) submission for the treatment of previously untreated extensive stage small cell lung cancer (ES-SCLC) in combination with chemotherapy Received NMPA acceptance of a sBLA submission for treatment plus platinum-based chemotherapy followed by adjuvant treatment of adult patients with resectable Stage II or IIIA NSCLC Received EMA acceptance of submission for the treatment of adult patients with first-line ESCC Clinical Activities BRUKINSA Announced positive follow-up data from the Phase 3 ALPINE study in R/R CLL/SLL versus IMBRUVICA at ASH showing sustained PFS benefit and persistently lower rates of cardiovascular events Tislelizumab Enrolled first patient in a Phase 1 clinical trial evaluating subcutaneous injection in the first-line treatment of patients with advanced or metastatic NSCLC Sonrotoclax (BGB-11417) FDA granted orphan designations for multiple myeloma (MM), Waldenstrom’s macroglobulinemia (WM), acute myeloid leukemia (AML), and mantle cell lymphoma (MCL) Enrolled first patient in a global pivotal trial in combination with BRUKINSA in first-line CLL Presented data at ASH demonstrating: Sonrotoclax is safe and tolerable in combination with BRUKINSA with deep and durable responses in TN CLL Encouraging data with potential to be first BCL2i approved in MM with t(11,14) Promising single-agent activity in patients with R/R MZL BTK CDAC (BGB-16673) Presented data at ASH from ongoing first-in-human study demonstrating notable clinical responses and a tolerable safety pro heavily pretreated patients with B-cell malignancies, including those with BTKi-resistant disease Enrolled first patients in R/R MCL expansion cohort with potential for registration Fast Track and Orphan Drug designations received from FDA for R/R MCL Anti-LAG3 (LBL-0071) In partnership with Leads Biolabs, first subject enrolled in a Phase 2 study as first-line treatment in patients with inoperable locally advanced or metastatic ESCC in combination with tislelizumab and chemotherapy Early development Fully enrolled the first two cohorts in Phase 1 clinical trials for NME BGB-43395 (CDK4 inhibitor) Anticipated Upcoming Milestones Key Highlights Secure FDA approval for BRUKINSA in combination with obinutuzumab in R/R FL, making it the BTK inhibitor with the broadest label in the class Receive FDA approval for tislelizumab in first- and second-line ESCC, demonstrating global expansion of innovative solid tumor portfolio Category Asset Anticipated Milestones Anticipated Regulatory Approvals BRUKINSA Receive FDA approval in combination with obinutuzumab for the treatment of adult patients with R/R FL who have received at least two prior lines of systemic therapy in March 2024 and NMPA approval in June 2024 Tislelizumab Receive FDA approval for the treatment of second-line ESCC in first half of 2024 Receive FDA approval for the treatment of first-line unresectable, recurrent, locally advanced, or metastatic ESCC with a target PDUFA in July 2024 Receive EMA approval for the treatment of first line metastatic NSCLC in combination with chemotherapy and second line metastatic NSCLC as monotherapy in the first half of 2024 Receive NMPA approval for the treatment of previously untreated ES-SCLC in combination with chemotherapy in the third quarter of 2024 Receive NMPA approval for the first-line treatment of inoperable, locally advanced, or metastatic gastric or gastroesophageal junction (G/GEJ) carcinoma in the second quarter of 2024 Anticipated Regulatory Submissions BRUKINSA Submit an sNDA for a new tablet formulation with the EMA and Health Canada in the first of half of 2024 and the FDA in the second half of 2024 Tislelizumab Submit a marketing application with the Japan PMDA for the treatment of first- and second-line ESCC in the first half of 2024 Submit an sBLA with the EMA for the first-line treatment of inoperable, locally advanced, or metastatic G/GEJ carcinoma in the first quarter of 2024 Zanidatamab2 In partnership with Jazz Pharmaceuticals and Zymeworks, submit a BLA with the NMPA for treatment of HER2-amplified inoperable and advanced or metastatic biliary tract cancer in the second half of 2024 Anticipated Clinical Activities Sonrotoclax Complete enrollment in a global Phase 2 trial in R/R MCL with potential for registration in the second quarter of 2024 Ociperlimab (Anti-TIGIT) Complete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in the first quarter of 2024 Tarlatamab3 (DLL3 x CD3 bispecific T-cell engager) In partnership with Amgen, begin China enrollment in a global Phase 3 trial in limited-stage small cell lung cancer in the second half of 2024 Early development Initiate first-in-human trials for at least 10 NMEs in 2024, including pan-KRAS inhibitor, MTA cooperative PRMT5 inhibitor, EGFR degrader, CDK2 inhibitor, ADCs, and bispecific immune cell engagers In partnership with Amgen3, enroll first patient in China in a Phase 1 study in metastatic castration-resistant prostate cancer for xaluritamig (AMG 509, STEAP1 x CD3 XmAb® T-cell engager molecule4) in the first half of 2024 1 Leads Biolabs collaboration; BeiGene has commercial rights excluding China 2 Jazz/Zymeworks collaboration; BeiGene has commercial rights in APAC (excluding Japan), Australia, New Zealand 3 Amgen collaboration; BeiGene will have commercial rights in China and tiered mid-single digit royalties on net sales outside of China 4 XmAb® is a registered trademark of Xencor, Inc. Manufacturing Operations Neared completion of $800 million U.S. flagship biologics manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, New Jersey, which is expected to be operational in July 2024; the property has more than 1 million square feet of total developable real estate, allowing for future expansion; Completed construction on new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction added more than 559,000 square feet and expanded production capacity to 1 billion solid dosage form units annually; and Completed construction of a 250,000-square-foot ADC production facility and additional 170,000-square-foot biologics clinical production capabilities at our state-of-the-art biologics facility in Guangzhou, China, which brings the total capacity to 65,000 liters. Corporate Developments Acquired an exclusive global license to a differentiated CDK2 inhibitor from Ensem Therapeutics, Inc., complementing the Company’s early development pipeline in breast cancer and other solid tumors. Financial Summary Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of December 31, December 31, 2023 2022 (audited) Assets: Cash, cash equivalents, restricted cash and short-term investments $ 3,188,584 $ 4,540,288 Accounts receivable, net 358,027 173,168 Inventories, net 416,122 282,346 Property, plant and equipment, net 1,324,154 845,946 Total assets $ 5,805,275 $ 6,379,290 Liabilities and equity: Accounts payable $ 315,111 $ 294,781 Accrued expenses and other payables 693,731 467,352 Deferred revenue 300 255,887 R&D cost share liability 238,666 293,960 Debt 885,984 538,117 Total liabilities 2,267,948 1,995,935 Total equity $ 3,537,327 $ 4,383,355 Condensed Consolidated Statements of Operations (U.S. GAAP) (Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 (unaudited) (audited) Revenue Product revenue, net $ 630,526 $ 339,022 $ 2,189,852 $ 1,254,612 Collaboration revenue 3,883 41,073 268,927 161,309 Total revenues 634,409 380,095 2,458,779 1,415,921 Cost of sales - products 105,832 73,522 379,920 286,475 Gross profit 528,577 306,573 2,078,859 1,129,446 Operating expenses Research and development 493,987 446,023 1,778,594 1,640,508 Selling, general and administrative 416,547 328,984 1,504,501 1,277,852 Amortization of intangible assets 1,838 188 3,500 751 Total operating expenses 912,372 775,195 3,286,595 2,919,111 Loss from operations (383,795) (468,622) (1,207,736) (1,789,665) Interest income, net 16,274 18,219 74,009 52,480 Other income (expense), net 16,749 19,438 307,891 (223,852) Loss before income taxes (350,772) (430,965) (825,836) (1,961,037) Income tax expense 16,781 14,370 55,872 42,778 Net loss (367,553) (445,335) (881,708) (2,003,815) Net loss per share $ (0.27) $ (0.33) $ (0.65) $ (1.49) Weighted-average shares outstanding—basic and diluted 1,353,005,058 1,348,916,108 1,357,034,547 1,340,729,572 Net loss per American Depositary Share (“ADS”) $ (3.53) $ (4.29) $ (8.45) $ (19.43) Weighted-average ADSs outstanding—basic and diluted 104,077,312 103,762,778 104,387,273 103,133,044 Note Regarding Use of Non-GAAP Financial Measures BeiGene provides certain non-GAAP financial measures, including Adjusted Operating Expenses and Adjusted Operating Loss and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeiGene’s operating performance. Adjustments to BeiGene’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. BeiGene maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeiGene believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeiGene’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeiGene’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (in thousands, except per share amounts) (unaudited) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 Reconciliation of GAAP to adjusted cost of sales - products: GAAP cost of sales - products $ 105,832 $ 73,522 $ 379,920 $ 286,475 Less: Depreciation 1,898 — 8,578 — Less: Amortization of intangibles 1,119 781 3,739 3,225 Adjusted cost of sales - products $ 102,815 $ 72,741 $ 367,603 $ 283,250 Reconciliation of GAAP to adjusted research and development: GAAP research and development $ 493,987 $ 446,023 $ 1,778,594 $ 1,640,508 Less: Share-based compensation expenses 39,424 34,966 163,550 139,348 Less: Depreciation 17,180 6,871 56,084 26,241 Adjusted research and development $ 437,383 $ 404,186 $ 1,558,960 $ 1,474,919 Reconciliation of GAAP to adjusted selling, general and administrative: GAAP selling, general and administrative $ 416,547 $ 328,984 $ 1,504,501 $ 1,277,852 Less: Share-based compensation expenses 53,328 43,160 204,038 163,814 Less: Depreciation 1,784 10,176 15,774 36,061 Adjusted selling, general and administrative $ 361,435 $ 275,648 $ 1,284,689 $ 1,077,977 Reconciliation of GAAP to adjusted operating expenses GAAP operating expenses 912,372 775,195 3,286,595 2,919,111 Less: Share-based compensation expenses 92,752 78,126 367,588 303,162 Less: Depreciation 18,964 17,047 71,858 62,302 Less: Amortization of intangibles 1,838 188 3,500 751 Adjusted operating expenses $ 798,818 $ 679,834 $ 2,843,649 $ 2,552,896 Reconciliation of GAAP to adjusted loss from operations: GAAP loss from operations $ (383,795) $ (468,622) $ (1,207,736) $ (1,789,665) Plus: Share-based compensation expenses 92,752 78,126 367,588 303,162 Plus: Depreciation 20,862 17,047 80,436 62,302 Plus: Amortization of intangibles 2,957 969 7,239 3,976 Adjusted loss from operations $ (267,224) $ (372,480) $ (752,473) $ (1,420,225) Please note that the figures presented above may not sum exactly due to rounding About BeiGene BeiGene is a global oncology company that is discovering and developing innovative 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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter). Forward-Looking Statements This 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 BeiGene’s progress towards becoming an impactful next-generation oncology innovator; the future of BeiGene’s oncology pipeline; BeiGene’s ability to grow revenue across new and existing geographies, particularly in the U.S.; the expected capacities and completion dates for the Company’s manufacturing facilities under construction and the potential for such facilities to increase manufacturing capabilities; BeiGene’s anticipated regulatory approvals, submissions and clinical activities; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene”. 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’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s 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 “Risk Factors” in BeiGene’s 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. IMBRUVICA® is a registered trademark of Pharmacyclics LLC. View source version on businesswire.com: Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beigene.com Source: BeiGene, Ltd. Smart Multimedia Gallery Document (Graphic: Business Wire) Logo View this news release online at: