Bemarituzumab

THOUSAND OAKS, Calif., May 2, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter 2024. "With many of our innovative products delivering strong growth and promising new medicines advancing through our pipeline, we are excited about delivering attractive long-term growth," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the first quarter, total revenues increased 22% to $7.4 billion in comparison to the first quarter of 2023. Product sales grew 22%, driven by 25% volume growth. Ten products delivered at least double-digit volume growth in the first quarter, including Repatha® (evolocumab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), and TAVNEOS® (avacopan). U.S. volume grew 29% and ex-U.S. volume grew 17%. Our performance included $914 million of sales from our Horizon Therapeutics (Horizon) acquisition, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase) and UPLIZNA® (inebilizumab-cdon). Excluding sales from Horizon, our product sales grew 6%, driven by volume growth of 9%. GAAP loss per share was $0.21 for the first quarter of 2024 compared with GAAP earnings per share (EPS) of $5.28 for the first quarter of 2023, driven by a mark-to-market loss on our BeiGene, Ltd. equity investment and higher operating expenses, including higher amortization expense from Horizon-acquired assets and incremental expenses from Horizon, partially offset by higher revenues. GAAP operating income decreased from $1.9 billion to $1.0 billion, and GAAP operating margin decreased 19.0 percentage points to 13.9%. Non-GAAP EPS decreased 1% from $3.98 to $3.96, due to higher operating and interest expenses driven by the Horizon acquisition, partially offset by higher revenues. Non-GAAP operating income increased from $2.8 billion to $3.1 billion, and non-GAAP operating margin decreased 5.1 percentage points to 43.2%. The Company generated $0.5 billion of free cash flow for the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items. Product Sales Performance Total product sales increased 22% for the first quarter of 2024 versus the first quarter of 2023, driven by 25% volume growth. General Medicine Repatha® sales increased 33% year-over-year to $517 million in the first quarter, driven by 44% volume growth, partially offset by 13% lower net selling price. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.9 million patients treated since launch. Prolia® (denosumab) generated $999 million of sales in the first quarter. Sales increased 8% year-over-year primarily driven by volume growth. EVENITY® sales increased 35% year-over-year to $342 million for the first quarter, primarily driven by volume growth. Oncology BLINCYTO® sales increased 26% year-over-year to $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia (B-ALL). Vectibix® (panitumumab) generated $247 million of sales in the first quarter. Sales increased 6% year-over-year driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact. KYPROLIS® (carfilzomib) sales increased 5% year-over-year to $376 million for the first quarter, primarily driven by volume growth outside the U.S. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 11% year-over-year to $82 million for the first quarter, driven by volume growth. XGEVA® (denosumab) sales increased 5% year-over-year to $561 million for the first quarter, primarily driven by volume growth outside the U.S. and higher net selling price, partially offset by lower volume in the U.S. Nplate® (romiplostim) generated $317 million of sales in the first quarter. Sales decreased 12% year-over-year, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the U.S. government order from this comparison, Nplate sales grew 13% year-over-year, primarily driven by volume growth. MVASI® (bevacizumab-awwb) generated $202 million of sales in the first quarter. Sales were flat year-over-year for the first quarter. Volume growth was largely offset by lower net selling price and unfavorable changes to estimated sales deductions. Going forward we expect continued net selling price erosion driven by competition. Inflammation TEZSPIRE® generated $173 million of sales in the first quarter. Sales increased 80% year-over-year, primarily driven by volume growth. Healthcare providers recognize TEZSPIRE's unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic or biomarker limitation. Otezla® (apremilast) generated $394 million of sales in the first quarter. Sales increased 1% year-over-year for the first quarter. Enbrel® (etanercept) generated $567 million of sales in the first quarter. Sales decreased 2% year-over-year driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. Otezla and Enbrel typically have lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles. AMJEVITA®/AMGEVITA™ (adalimumab) generated $168 million of sales in the first quarter. Sales increased 2% year-over-year primarily driven by international growth, partially offset by lower inventory levels and unfavorable change to estimated sales deductions. Rare Disease Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023. TEPEZZA® (teprotumumab-trbw) generated $424 million of sales in the first quarter. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED). KRYSTEXXA® (pegloticase) generated $235 million of sales in the first quarter. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout. UPLIZNA® (inebilizumab-cdon) generated $80 million of sales in the first quarter. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorders. TAVNEOS® generated $51 million of sales in the first quarter. Sales increased 122% year-over-year, driven by volume growth. Ultra rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) and QUINSAIR® (levofloxacin), generated $169 million of sales in the first quarter. Established Products Our established products, which consist of EPOGEN® (epoetin alfa), Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $613 million of sales. Sales decreased 19% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and volume declines. In the aggregate, we expect the year-over-year volume declines for this portfolio of products to continue. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 54%. Cost of Sales as a percentage of product sales increased 15.6 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 27% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses increased 44% primarily driven by commercial expenses related to Horizon-acquired products, general and administrative expenses, and acquisition-related costs. Other operating expenses consisted primarily of a net impairment charge for an in-process R&D asset and changes in contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. Operating Margin as a percentage of product sales decreased 19.0 percentage points in the first quarter to 13.9%. Tax Rate decreased 83.7 percentage points primarily due to the GAAP net loss described above and the change in earnings mix as a result of the inclusion of the Horizon business. On a non-GAAP basis: Total Operating Expenses increased 33%. Cost of Sales as a percentage of product sales increased 1.4 percentage points driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 26% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. SG&A expenses increased 40%, primarily driven by commercial expenses related to Horizon-acquired products, and general and administrative expenses. Operating Margin as a percentage of product sales decreased 5.1 percentage points in the first quarter to 43.2%. Tax Rate decreased 2.4 percentage points primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items in the quarter. Cash Flow and Balance Sheet The Company generated $0.5 billion of free cash flow in the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items. The Company's first quarter 2024 dividend of $2.25 per share was declared on December 12, 2023, and was paid on March 7, 2024, to all stockholders of record as of February 16, 2024, representing a 6% increase from this same period in 2023. Cash and investments totaled $9.7 billion and debt outstanding totaled $64.0 billion as of March 31, 2024. 2024 Guidance For the full year 2024, the Company now expects: Total revenues in the range of $32.5 billion to $33.8 billion. On a GAAP basis, EPS in the range of $7.15 to $8.40, and a tax rate in the range of 9.5% to 11.0%. On a non-GAAP basis, EPS in the range of $19.00 to $20.20, and a tax rate in the range of 15.0% to 16.0%. Capital expenditures to be approximately $1.1 billion. Share repurchases not to exceed $500 million. First Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide, AMG 133) A Phase 2 study of MariTide, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon like peptide 1 (GLP-1) receptor, in adults with overweight or obesity with or without type 2 diabetes mellitus is ongoing, with topline data anticipated in late 2024. Planning for a comprehensive Phase 3 program across multiple indications remains on track. AMG 786 A Phase 1 study of AMG 786, a small molecule obesity program, is complete. Olpasiran (AMG 890) The Ocean(a)-Outcomes trial, a Phase 3 cardiovascular outcomes study of olpasiran in patients with atherosclerotic cardiovascular disease and elevated Lp(a), is fully enrolled. Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. Repatha EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular (CV) events, continues to enroll patients. VESALIUS-CV, a Phase 3 CV outcomes study of Repatha in patients at high CV risk without prior myocardial infarction or stroke, is ongoing. In April, data were presented from the FOURIER trial demonstrating that intensive LDL-C lowering with Repatha may lead to greater relative and absolute CV event reduction in patients with autoimmune or inflammatory diseases. In April, data were presented from the FOURIER and FOURIER-OLE studies demonstrating that elderly patients (≥75 years) with atherosclerotic cardiovascular disease derived similar to greater CV benefit compared to younger patients (<75 years) with early initiation of Repatha and up to 8.6 years of treatment with no significant safety concerns. Oncology Tarlatamab (AMG 757) The U.S. Food and Drug Administration (FDA) review of the Biologics License Application (BLA) for tarlatamab, a first-in-class investigational delta-like ligand 3 (DLL3) targeting BiTE® (bispecific T-cell engager) molecule in previously treated small cell lung cancer (SCLC) continues under priority review with a Prescription Drug User Fee Act (PDUFA) date of June 12, 2024. Additional regulatory submissions are underway or complete in countries outside of the U.S. Advancing a comprehensive global clinical development program in SCLC: DeLLphi-304, a Phase 3 study comparing tarlatamab with standard of care chemotherapy in second-line SCLC, continues to enroll patients. DeLLphi-305, a Phase 3 study comparing tarlatamab and durvalumab with durvalumab alone in first-line, extensive-stage SCLC, was initiated. DeLLphi-306, a Phase 3 study comparing tarlatamab with placebo following concurrent chemoradiation therapy in limited-stage SCLC is enrolling patients. DeLLphi-300, a Phase 1 study of tarlatamab in relapsed/refractory SCLC is ongoing. DeLLphi-302, a Phase 1b study of tarlatamab in combination with AMG 404, an anti-programmed cell death protein 1 (PD1) monoclonal antibody, in second-line or later SCLC, is ongoing. DeLLphi-303, a Phase 1b study of tarlatamab in combination with standard of care in first-line SCLC, continues to enroll patients. DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer, is ongoing. Initial data from this study will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June. Additional data from the DeLLphi-301 Phase 2 trial, highlighting the efficacy and safety of tarlatamab analyzed by the presence of brain metastasis, will be presented at the ASCO annual meeting in June. BLINCYTO The FDA review of the supplemental BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) continues under priority review, with a PDUFA date of June 21, 2024. Additional regulatory submissions are underway or complete in countries outside of the U.S. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome-negative (Ph-) B-ALL, continues to enroll patients. The Company is planning to advance blinatumomab subcutaneous administration through a registration enabling study, with initiation anticipated H2 2024 to H1 2025. A Phase 1/2 study of subcutaneous blinatumomab in adults with relapsed or refractory Ph- B-ALL continues to enroll patients. Xaluritamig (AMG 509) A Phase 1 monotherapy dose-expansion study of xaluritamig, a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) in metastatic castrate resistant prostate cancer has completed initial enrollment in the monotherapy portion of the study and continues to enroll subjects to explore reduced monitoring after treatment administration. An outpatient treatment cohort has also been initiated to improve administration convenience. A Phase 1 combination with abiraterone or enzalutamide continues to enroll patients in the dose-escalation phase, with plans to initiate expansion cohorts. Two additional Phase 1 studies of xaluritamig to evaluate preliminary efficacy and safety in patients with early prostate cancer are planned. AMG 193 A Phase 1/1b/2 study of AMG 193, a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, continues to enroll patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors in the dose-expansion portion of the study. A Phase 1b study of AMG 193 alone or in combination with other therapies in patients with advanced MTAP-null thoracic tumors was initiated. A Phase 1b study of AMG 193 in combination with other therapies in patients with advanced MTAP-null gastrointestinal, biliary tract, or pancreatic cancers was initiated. A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients. Nplate A Phase 3 study of Nplate in chemotherapy-induced thrombocytopenia in gastrointestinal, pancreatic, or colorectal malignancies is fully enrolled. Data readout is anticipated in H2 2024. LUMAKRAS/LUMYKRAS A Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI in first-line KRAS G12C–mutated CRC is enrolling patients. A U.S. regulatory submission for the Phase 3 CodeBreaK 300 trial is on track for H1 2024. This study evaluated two doses of LUMAKRAS (960 mg or 240 mg) in combination with Vectibix in patients with chemorefractory KRAS G12C–mutated metastatic colorectal cancer (CRC). Overall survival (OS) data from the Phase 3 CodeBreaK 300 study of LUMAKRAS plus Vectibix vs. investigator's choice of therapy in KRAS G12C–mutated metastatic CRC will be presented at the ASCO annual meeting in June. A Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy in first-line KRAS G12C–mutated and programmed cell death protein ligand-1 (PD-L1) negative advanced non-small cell lung cancer (NSCLC) is enrolling patients. Regulatory review by the European Medicines Agency (EMA) of the CodeBreaK 200 Phase 3 trial of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC along with data from the Phase 2 dose-comparison substudy is ongoing. Updated analysis from the CodeBreaK 101 trial investigating LUMAKRAS plus carboplatin and pemetrexed in KRAS G12C advanced NSCLC will be presented at the ASCO annual meeting in June. Bemarituzumab FORTITUDE-101, a Phase 3 study of bemarituzumab, a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, plus chemotherapy in first-line gastric cancer, continues to enroll patients. FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer, continues to enroll patients in the Phase 3 portion of the study. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab in first-line gastric cancer, continues to enroll patients. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, is ongoing. Inflammation TEZSPIRE A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary disease (COPD) is complete. Overall, TEZSPIRE numerically reduced the annualized rate of moderate or severe COPD exacerbations vs. placebo by 17% (90% CI: −6, 36; p=0.1042). Of note, more reductions were observed in a subgroup of patients with baseline BEC ≥ 150 cells/μL (37% [95% CI: 7, 57]). The trend in reduction was greater in a small number of subjects with BEC ≥ 300 cells/µL. Data will be presented at the American Thoracic Society Conference (ATS) later this month. A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with nasal polyps is fully enrolled. Primary analysis is anticipated in H2 2024. In severe asthma, the WAYFINDER Phase 3b study is fully enrolled. The PASSAGE Phase 4 real-world effectiveness study and the SUNRISE Phase 3 study continue to enroll patients. A Phase 3 study of TEZSPIRE in eosinophilic esophagitis continues to enroll patients. Rocatinlimab (AMG 451/KHK4083) The ROCKET Phase 3 program, evaluating rocatinlimab, a first in class monoclonal antibody targeting OX40, in moderate to severe atopic dermatitis, is composed of eight studies enrolling adult and adolescent patients. To date, over 2,800 patients have been enrolled in the ROCKET program with three studies having completed enrollment. The Phase 3 HORIZON study (part of the ROCKET program), evaluating rocatinlimab monotherapy vs. placebo in adults with moderate to severe atopic dermatitis, is fully enrolled. Data readout is anticipated in H2 2024. A Phase 2 study of rocatinlimab in moderate to severe asthma was initiated. A Phase 3 study of rocatinlimab in prurigo nodularis will be initiated in H2 2024. Otezla In April, the FDA granted pediatric exclusivity and approved Otezla for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This is the first pediatric indication for Otezla. In March, data were presented from: the SPROUT Phase 3 study, where 52 weeks of treatment with Otezla demonstrated sustained efficacy and safety in pediatric patients with moderate to severe plaque psoriasis. a Phase 3 study in Japanese Palmoplantar Pustulosis (PPP) patients where 16 weeks of treatment with Otezla demonstrated statistical significance for the primary efficacy endpoint, PPPASI 50 response, and for all secondary endpoints. Otezla improved disease severity, symptoms, and quality of life, with no new safety signals identified. These data will be submitted to regulators in Japan. Efavaleukin alfa (AMG 592) A Phase 2b study of efavaleukin alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, in ulcerative colitis continues to enroll patients. Ordesekimab (AMG 714/PRV-015) A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, in nonresponsive celiac disease has completed enrollment. AMG 104 (AZD8630) The Company plans to present data from the Phase 1 study of AMG 104, an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab), in healthy volunteers and patients with asthma, at ATS later this month. Rare Disease TAVNEOS A Phase 3, open-label, uncontrolled single-arm study to evaluate the efficacy, pharmacokinetics, and safety of TAVNEOS in combination with Rituximab or a cyclophosphamide-containing regimen in children from 6 years to < 18 years of age with active ANCA-associated vasculitis will be initiated in H2 2024. TEPEZZA Regulatory review of the New Drug Application (NDA) for TEPEZZA in Japan continues. Regulatory submissions for TEPEZZA were completed in Australia, Canada, Great Britain and the European Medicines Agency (EMA). A Phase 3 study of TEPEZZA in Japan for chronic or low clinical activity score TED continues to enroll patients. A Phase 3 study evaluating the subcutaneous route of administration of TEPEZZA in patients with TED was initiated. KRYSTEXXA The Phase 4 AGILE study of KRYSTEXXA with methotrexate evaluating a shorter infusion duration was completed. At the 60-minute infusion duration, 67.2% of patients (78 of 116) achieved a response. The safety profile was in line with the current administration of KRYSTEXXA with methotrexate over no less than 120 minutes. Detailed data will be presented at a future medical conference. UPLIZNA A Phase 3 study of UPLIZNA in myasthenia gravis is fully enrolled. Data readout is anticipated in H2 2024. A Phase 3 study of UPLIZNA for the prevention of flare in immunoglobulin G4- (IgG4) related disease is fully enrolled. Data readout is anticipated in H2 2024. Dazodalibep Two Phase 3 studies of dazodalibep, a CD40 (cluster of differentiation 40) ligand inhibitor fusion protein, in Sjögren's disease are enrolling patients. The first study is in patients with moderate to severe systemic disease activity, and the second study is in patients with moderate to severe symptomatic burden and low to no systemic disease activity. A manuscript based on data from the Phase 2 Dazodalibep Sjogren's disease study has been accepted for publication in Nature Medicine. Daxdilimab A Phase 2 study of daxdilimab, a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7), in moderate to severe active primary discoid lupus erythematosus refractory to standard of care is enrolling patients. A Phase 2 study of daxdilimab in dermatomyositis and antisynthetase inflammatory myositis is enrolling patients. Fipaxalparant (formerly AMG 670/HZN 825) A Phase 2 study of fipaxalparant, a lysophosphatidic acid receptor 1 (LPAR1) antagonist, in idiopathic pulmonary fibrosis has completed enrollment. Data readout is anticipated in H2 2024. A Phase 2 study of fipaxalparant in diffuse cutaneous systemic sclerosis is enrolling patients. Biosimilars The clinical comparative study portion of a randomized, double-blind pivotal study evaluating pharmacokinetic (PK) similarity of ABP 206 compared with OPDIVO® (nivolumab) in resected stage III or stage IV melanoma patients in the adjuvant setting is enrolling patients. The Company initiated a randomized, double-blind Phase 3 study to compare efficacy, pharmacokinetics, safety, and immunogenicity between ABP 234 and Keytruda® (pembrolizumab) in subjects with advanced or metastatic non-squamous non-small cell lung cancer. TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio, a Sanofi Company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the first quarters of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2024 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.  Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. ### CONTACT: Amgen, Thousand Oaks Jessica Akopyan, 805-440-5721 (media) Justin Claeys, 805-313-9775 (investors) * The known adjustments are presented net of their related tax impact, which amount to approximately $2.61 per share. (a) The adjustments primarily include noncash amortization of intangible assets and fair value step-up of inventory acquired in business combinations. Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. SOURCE Amgen

Total product revenue of $266.7 million for Full-Year 2023, representing 25% y-o-y growth; 31% y-o-y growth at constant exchange rate (CER) VYVGART® (efgartigimod alfa injection) was launched in September 2023 in China and we estimate that nearly 1,000 patients were treated through the fourth quarter before its listing on China’s National Reimbursement Drug List (NRDL) We estimate that nearly 1,000 new patients were treated with VYVGART in January 2024 alone; expect VYVGART product sales to exceed $70.0 million in 2024 Regulatory reviews ongoing for sulbactam-durlobactam, efgartigimod SC and repotrectinib; up to four new regulatory submissions expected in 2024 Strong balance sheet with a cash position of $807.6 million as of December 31, 2023, compared to $1.0 billion as of December 31, 2022 Company to host conference call and webcast on February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for full-year 2023, along with recent product highlights and corporate updates. “We made excellent progress on several key strategic priorities in 2023, notably the launch of VYVGART in China for generalized myasthenia gravis (gMG) in September and the drug’s successful inclusion on China’s NRDL for this indication effective January 1, 2024,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The launch is off to an impressive start with more patients treated with VYVGART in January than the last four months of 2023 combined, fueled by high physician adoption and increased patient access as hospitals add VYVGART to formularies. Looking ahead, we expect strong commercial performance across our portfolio this year, and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and our growing global early-stage development efforts. We are on track to achieve the objectives outlined in our five-year strategic plan and to position Zai Lab as a high-growth, profitable and innovative biotech company.” “We are focused on achieving three corporate objectives,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “First, we seek to accelerate top-line growth supported by multiple launches of new products and indications over the next two to three years. Second, we aim to reach corporate profitability by the end of 2025 through revenue growth and continued focus on efficiency and productivity. Third, we are committed to building a global portfolio through our internal discovery activities and strategic business development. These corporate objectives capture our vision for Zai Lab, where we lead with innovation, grow with purpose, and deliver on our mission of improving patient lives globally,” Mr. Smiley concluded. Full-Year 2023 Financial Results Product revenue was $266.7 million in 2023, compared to $212.7 million in 2022, representing 25% y-o-y growth and 31% y-o-y growth at CER. This increase was primarily driven by increased sales volumes, the launch of VYVGART, and decreased negative effects from the COVID-19 pandemic, partially offset by an increase in sales rebates to distributors and the effects on hospital and physician practices from the recent industry-wide anti-corruption enforcement efforts in China in the second half of 2023. Sales rebates to distributors resulting from price reductions in connection with NRDL listings were $13.0 million in 2023, up from $5.3 million in 2022, driven by an increased number of new and renewed NRDL listings. Key Highlights by Commercial Products ZEJULA® $168.8 million in 2023, which increased 16% y-o-y from $145.2 million in 2022. The increase was driven by increased hospital sales in first-line ovarian cancer and duration of treatment prolongment, partially offset by sales rebates in connection with the renewal in the NRDL. ZEJULA continues to be the leading PARP inhibitor in hospital sales for ovarian cancer in China, in its third year on the NRDL. ZEJULA’s NRDL listing was renewed for the maintenance treatment of adult patients with first-line and recurrent ovarian cancer, effective January 1, 2024. VYVGART® $10.0 million in 2023, compared to nil in 2022. We successfully launched VYVGART for the treatment of adult patients with gMG, who are anti-acetylcholine receptor (AChR) antibody positive, in September 2023. We estimate that nearly 1,000 patients were treated from launch through the fourth quarter of 2023. VYVGART was added to the NRDL for the treatment of gMG, effective January 1, 2024. We estimate that nearly 1,000 new patients were treated in January 2024 alone driven by positive physician and patient reception as well as increased patient access as VYVGART is added to hospital formularies. We are expecting more than $70.0 million in VYVGART revenue in 2024. OPTUNE® $47.0 million in 2023, which was relatively flat compared to $47.3 million in 2022. Continued growth in supplemental insurance coverage was offset by the effects of industry-wide anti-corruption efforts. QINLOCK® $19.2 million in 2023, which increased 29% y-o-y from $15.0 million in 2022. Growth was supported by its inclusion in the NRDL in the first quarter of 2023 for the fourth-line treatment of advanced gastrointestinal stromal tumors (GIST), partially offset by sales rebates in connection with the NRDL listing. NUZYRA® $21.7 million in 2023, which increased by 316% y-o-y from $5.2 million in 2022. Growth was driven by the initial inclusion of NUZYRA (IV formulation) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the NRDL in the first quarter of 2023. The oral formulation of NUZYRA was added to the NRDL for these indications, effective January 1, 2024, which we expect to further increase patient access. Research and Development (R&D) expenses were $265.9 million for 2023, compared to $286.4 million for 2022. This decrease was primarily due to decreased upfront and milestone payments for our license and collaboration agreements, partially offset by an increase in personnel compensation and related costs. Selling, General and Administrative expenses were $281.6 million for 2023, compared to $259.0 million for 2022. This increase was primarily due to higher general selling expenses related to commercial operations to support the launch of VYVGART, partially offset by a decrease in professional services fees. Net loss was $334.6 million for 2023, or a loss per ordinary share attributable to common stockholders of $0.35 (or loss per American Deposit Share (“ADS”) of $3.46), compared to a net loss of $443.3 million for 2022, or a loss per ordinary share of $0.46 (or loss per ADS of $4.63). The decrease in net loss was primarily due to product revenue growing faster than net operating expenses, increased interest income, and decreased foreign currency loss. Cash and cash equivalents, short-term investments and restricted cash totaled $807.6 million as of December 31, 2023, compared to $1.0 billion as of December 31, 2022. 2024 Strategic Priorities Zai Lab will focus on the following strategic priorities in 2024 to drive innovation in China and beyond: Commercial Execution Drive VYVGART ramp-up in gMG in its first year of NRDL inclusion and increase access via hospital listing Maintain ZEJULA leadership position in ovarian cancer in China Continue to grow supplemental insurance coverage for OPTUNE GIO® in glioblastoma (GBM) Successfully launch additional products (up to 3) from our innovative pipeline Clinical Data and Regulatory Actions Potential China approvals: Sulbactam-durlobactam in infections caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex Efgartigimod SC in gMG Repotrectinib in ROS1-positive NSCLC Planned China submissions: Efgartigimod SC in chronic inflammatory demyelinating polyneuropathy (CIDP) Adagrasib in second-line+ NSCLC Tisotumab vedotin in second-line+ cervical cancer Tumor Treating Fields in second-line+ NSCLC Key clinical data readouts: Tumor Treating Fields in first-line brain metastases from NSCLC (METIS) and first-line locally advanced pancreatic cancer (PANOVA-3) Adagrasib in first-line NSCLC and second-line+ NSCLC Clinical Development Join the global Phase 3 registrational study of efgartigimod in thyroid eye disease (TED) in Greater China1 Join the global Phase 3 ADEPT-2 and ADEPT-3 studies of xanomeline-trospium (or KarXT) in Alzheimer’s disease psychosis (ADP) in Greater China Complete enrollment in the China bridging Phase 3 study of xanomeline-trospium (or KarXT) in schizophrenia Advance ZL-1102 (IL-17 Humabody®) into global Phase 2 development in chronic plaque psoriasis (CPP) Enroll patients in the global Phase 1 study for ZL-1310 (DLL3 ADC) in small cell lung cancer (SCLC) 1 Mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China). Recent Pipeline Highlights Below are key product updates since our last earnings release: Oncology Pipeline Tumor Treating Fields: In January 2024, Zai Lab partner Novocure announced that the U.S. Food and Drug Administration (FDA) had accepted for filing its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields therapy together with standard systemic therapies for the treatment of NSCLC, following progression on or after platinum-based therapy. We are preparing a similar submission for this indication, with a goal to submit a Marketing Authorization Application (MAA) to the National Medical Products Administration (NMPA) in 2024. Repotrectinib (ROS1/TRK): In February 2024, Zai Lab partner Bristol-Myers Squibb (BMS) announced that, based on the results of the TRIDENT-1 trial, the FDA has accepted its supplemental NDA (sNDA) for repotrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. The application was granted priority review status, with a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024. In November 2023, BMS announced that, based on results from the TRIDENT-1 trial, the FDA approved repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review. Adagrasib (KRASG12C) In February 2024, Zai Lab partner BMS announced that, based on the results of the KRYSTAL-1 trial, the FDA has accepted its sNDA for adagrasib in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The application was granted priority review status, with a PDUFA goal date of June 21, 2024. We are participating in the global confirmatory Phase 3 KRYSTAL-10 study in second-line KRASG12C-mutated CRC in Greater China. Bemarituzumab (FGFR2b): Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China. We expect the first patient in Greater China to be treated in the first quarter of 2024. ZL-1310 (DLL3 ADC): Zai Lab is currently enrolling patients in the United States and China in the global Phase 1 study in relapsed and refractory second-line+ SCLC who have progressed after platinum-based treatment. Autoimmune Disorders, Infectious Disease, and Neuroscience Pipeline Efgartigimod (FcRn): In February 2024, argenx announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for efgartigimod SC for the treatment of CIDP with priority review. The application has been granted a PDUFA goal date of June 21, 2024. We plan to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024. Xanomeline-Trospium (or KarXT) (M1/M4-agonist): In November 2023, Karuna announced that the FDA has accepted its NDA for xanomeline-trospium for the treatment of schizophrenia in adults. The application has been granted a PDUFA goal date of September 26, 2024. We continue to enroll patients in the registrational bridging study in mainland China, and we expect to complete the study this year. In November 2023, Karuna announced positive results from its Phase 1b open-label, eight-week inpatient trial evaluating the effect of xanomeline-trospium on 24-hour ambulatory blood pressure in adults with schizophrenia demonstrating that xanomeline-trospium was not associated with increases in blood pressure. Anticipated Major Milestones in 2024 Oncology Tumor Treating Fields Zai Lab to submit an MAA to the NMPA in second-line+ NSCLC, following progression on or after platinum-based therapy. Zai Lab partner Novocure to provide a topline data readout from the phase 3 METIS clinical trial in brain metastases from NSCLC in the first quarter of 2024. We are participating in the study in Greater China. Novocure to provide a topline data readout from the phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the fourth quarter of 2024. We are participating in the study in Greater China. Repotrectinib (ROS1/TRK) Potential NMPA approval of the NDA in locally advanced or metastatic ROS1-positive NSCLC. Adagrasib (KRASG12C) Zai Lab to submit an NDA to the NMPA in second-line+ KRASG12C-mutated NSCLC. Zai Lab to join the global Phase 3 KRYSTAL-7 study in first-line KRASG12C-mutated NSCLC with Tumor Proportion Score (TPS) ≥ 50% in Greater China in the second half of 2024. Zai Lab partner Mirati, a BMS company, to provide a clinical data update for the global confirmatory Phase 3 KRYSTAL-12 study in second-line+ KRASG12C-mutated NSCLC. We are participating in the study in Greater China. Mirati to provide a clinical data update for the global Phase 2 KRYSTAL-17 study in first-line KRASG12C-mutated NSCLC with TPS < 50%. Tisotumab Vedotin (Tissue Factor ADC) Zai Lab to submit an NDA to the NMPA in second-line+ cervical cancer. Neuroscience, Autoimmune Disorders, and Infectious Diseases (NSAiID) Efgartigimod (FcRn) Potential NMPA approval of the sBLA for efgartigimod SC in gMG. Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024. Zai Lab partner argenx to initiate a registrational study of efgartigimod in TED. Zai Lab plans to participate in the study in Greater China in the second half of 2024. Sulbactam-Durlobactam (SUL-DUR) Potential NMPA approval of the NDA in infections caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Xanomeline-Trospium (or KarXT) (M1/M4-agonist) Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024. Zai Lab to join the global Phase 3 ADEPT-2 and ADEPT-3 studies in ADP in Greater China in mid-year. Zai Lab partner Karuna to report topline data from the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety for treatment of schizophrenia in the second half of 2024. ZL-1102 (IL-17 Humabody®) Zai Lab to initiate a global Phase 2 study in mild-to-moderate chronic plaque psoriasis in mid-year. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast tomorrow, February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at . Participants must register in advance of the conference call. Details are as follows: Registration Link: All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company's website. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at . Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars, which are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on trends. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; and financial guidance, including with respect to our planned sources and uses of cash and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and on the SEC’s website at . Zai Lab Limited Consolidated Balance Sheets (in thousands of U.S. dollars (“$”), except for number of shares and per share data) December 31, 2023 2022 Assets Current assets Cash and cash equivalents 790,151 1,008,470 Short-term investments 16,300 — Accounts receivable (net of allowance for credit loss of $17 and $11 as of December 31, 2023 and 2022, respectively) 59,199 39,963 Notes receivable 6,134 8,608 Inventories, net 44,827 31,621 Prepayments and other current assets 22,995 35,674 Total current assets 939,606 1,124,336 Restricted cash, non-current 1,113 803 Long-term investments 9,220 6,431 Prepayments for equipment 111 1,396 Property and equipment, net 53,734 57,863 Operating lease right-of-use assets 14,844 19,512 Land use rights, net 3,069 6,892 Intangible assets, net 13,389 1,511 Long-term deposits 1,209 1,396 Total assets 1,036,295 1,220,140 Liabilities and shareholders’ equity Current liabilities Accounts payable 112,991 65,974 Current operating lease liabilities 7,104 7,050 Other current liabilities 82,972 66,818 Total current liabilities 203,067 139,842 Deferred income 28,738 21,360 Non-current operating lease liabilities 8,047 13,343 Other non-current liabilities 325 — Total liabilities 240,177 174,545 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized, 977,151,270 and 962,455,850 shares issued as of December 31, 2023 and 2022, respectively; 972,239,070 and 960,219,570 shares issued and outstanding as of December 31, 2023 and 2022, respectively) 6 6 Additional paid-in capital 2,975,302 2,893,120 Accumulated deficit (2,195,980 ) (1,861,360 ) Accumulated other comprehensive income 37,626 25,685 Treasury stock (at cost, 4,912,200 and 2,236,280 shares as of December 31, 2023 and 2022, respectively) (20,836 ) (11,856 ) Total shareholders’ equity 796,118 1,045,595 Total liabilities and shareholders’ equity 1,036,295 1,220,140 Zai Lab Limited Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) Year Ended December 31, 2023 2022 2021 Revenues Product revenue, net 266,719 212,672 144,105 Collaboration revenue — 2,368 207 Total revenues 266,719 215,040 144,312 Expenses Cost of sales (95,816 ) (74,018 ) (52,239 ) Research and development (265,868 ) (286,408 ) (573,306 ) Selling, general and administrative (281,608 ) (258,971 ) (218,831 ) Gain on sale of intellectual property 10,000 — — Loss from operations (366,573 ) (404,357 ) (700,064 ) Interest income 39,797 14,582 2,190 Foreign currency (loss) gain (14,850 ) (56,403 ) 4,661 Other income (expense), net 7,006 3,113 (10,201 ) Loss before income tax and share of loss from equity method investment (334,620 ) (443,065 ) (703,414 ) Income tax expense — — — Share of loss from equity method investment — (221 ) (1,057 ) Net loss (334,620 ) (443,286 ) (704,471 ) Loss per share — basic and diluted (0.35 ) (0.46 ) (0.76 ) Weighted-average shares used in calculating net loss per ordinary share — basic and diluted 966,394,130 958,067,140 929,921,120 Note: Basic and diluted net loss per ordinary share, weighted average number of ordinary shares for the year ended December 31, 2021 have been retrospectively adjusted as a result of the Share Subdivision that became effective on March 30, 2022. Zai Lab Limited Consolidated Statements of Comprehensive Loss (in thousands of $) Year Ended December 31, 2023 2022 2021 Net loss (334,620 ) (443,286 ) (704,471 ) Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments 11,941 49,330 (9,121 ) Comprehensive loss (322,679 ) (393,956 ) (713,592 ) Zai Lab Limited Non-GAAP Measures (In thousands of $) Year Ended December 31, Year over Year % Growth 2023 2022 As reported At CER* Product revenue, net 266,719 212,672 25 % 31 % Loss from operations (366,573 ) (404,357 ) (9 )% (7 )% * The growth rates at constant exchange rates (CER) were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods.