Slide 1: Q3 '23 Earnings Call
Q3 ’23 Earnings Call October 31, 2023
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation 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 outco
Slide 3: Agenda
Agenda Introduction Justin Claeys Opening Remarks Bob Bradway Global Commercial Update Murdo Gordon Rare Disease Update Vikram Karnani Research & Development Update David Reese Q3 ’23 Results and Outlook Peter Griffith Q&A All Provided October 31, 2023, as part of an oral presentation and is qualifi
Slide 4: We Are Raising Our Full Year Outlook and Have Completed the Acquisition of Horizon Therapeutics
We Are Raising Our Full Year Outlook and Have Completed the Acquisition of Horizon Therapeutics • Achieved 11% volume growth, with record sales for 7 brands • Added Horizon’s rare disease medicines; strong strategic fit with our broad innovative portfolio • Expanded our international footprint, with
Slide 5: Global Commercial Update
Global Commercial Update
Slide 6: Q3 '23 Global Commercial Update
Q3 ’23 Global Commercial Update Q3 ’23 Q3 ’22 YoY $ Millions, Net Sales U.S. ROW Total Total Total Repatha® 183 223 406 309 31% Prolia® 673 313 986 862 14% EVENITY® 214 93 307 201 53% Aimovig® 88 6 94 107 (12%) TEZSPIRE® 161 — 161 55 * TAVNEOS® 32 5 37 — NM Otezla® 462 105 567 627 (10%) Enbrel® 1,02
Slide 7: Product Sales Grew 5% YoY in Q3 '23, Driven by 11% Volume Growth
Product Sales Grew 5% YoY in Q3 ’23, Driven by 11% Volume Growth $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • Record quarterly sales for 7 products Total Change 5% (2%) ROW Units 11% 1% • Delivered double-digit volume growth in U.S. Inventory 1% 1% Q3 for a number of products, including BLINCYT
Slide 8: Repatha Volume Grew 44% YoY
Repatha® Volume Grew 44% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • Global PCSK9 segment leader Total Change 31% (4%) ROW Units 44% 14% • YoY sales increased 31%, driven by 44% U.S. Inventory 0% 0% volume growth, partially offset by lower net selling price* • U.S. sales grew 29% YoY • Ex-
Slide 9: Prolia Sales Grew 14% YoY
Prolia® Sales Grew 14% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 14%, primarily Total Change 14% (4%) ROW Units 7% (8%) driven by 7% volume growth and higher U.S. Inventory 2% 2% net selling price* • We are on track to treat over 7 million patients with Prolia® in 202
Slide 10: EVENITY Achieved Record Quarterly Sales
EVENITY® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 53%, driven by Total Change 53% 9% ROW Units 48% (1%) strong volume growth U.S. Inventory 7% 8% • U.S. volumes grew 41% YoY • Ex-U.S. volumes grew 63% YoY Note: Inventory represents wholesa
Slide 11: TEZSPIRE Sales Increased 21% QoQ
TEZSPIRE® Sales Increased 21% QoQ $ Millions, Net Sales Highlights Q3 ’23 QoQ • 18% QoQ volume growth benefited from Total Change 21% Units 18% the recently approved pre-filled, single- U.S. Inventory 6% use pen • TEZSPIRE®'s unique, differentiated profile has broad potential to treat 2.5 million pa
Slide 12: TAVNEOS Sales Increased 23% QoQ
TAVNEOS® Sales Increased 23% QoQ $ Millions, Net Sales Highlights Q3 ’23 QoQ • QoQ sales increased 23%, driven by Total Change 23% ROW Units 26% volume growth U.S. Inventory (18%) • U.S. volumes grew 18% QoQ • In the U.S., approximately 2,300 patients have now been treated with TAVNEOS® 1 Note: Inve
Slide 13: Otezla Volume Grew 1% YoY
Otezla® Volume Grew 1% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales decreased 10%, driven by lower net Total Change (10%) (6%) selling price*, unfavorable changes to ROW Units 1% (1%) U.S. estimated sales deductions and lower Inventory (2%) 0% inventory levels, partially offset by
Slide 14: Enbrel Volume Grew 1% YoY
Enbrel® Volume Grew 1% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales decreased 6%, primarily Total Change (6%) (3%) ROW Units 1% (1%) driven by unfavorable changes to U.S. Inventory 0% 1% estimated sales deductions • YoY volume increased 1%, driven by an increase in new patients st
Slide 15: AMGEVITA Ex-U.S. Volume Grew 22% YoY
AMGEVITA™ Ex-U.S. Volume Grew 22% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 30%, driven by 53% Total Change 30% 1% ROW Units 53% 6% volume growth, partially offset by lower U.S. Inventory (5%) (2%) net selling price* • Ex-U.S. sales increased 10% YoY, driven by 22% vo
Slide 16: BLINCYTO Achieved Record Quarterly Sales
BLINCYTO® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 55%, driven by 56% Total Change 55% 7% ROW Units 56% 14% volume growth U.S. Inventory 3% 1% • Volume growth was supported by broad prescribing for patients with B-cell precursor acute lymp
Slide 17: Vectibix Achieved Record Quarterly Sales
Vectibix® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 2%, driven by Total Change 2% 2% ROW Units 4% 2% higher net selling price* and 4% volume U.S. Inventory 0% 0% growth, partially offset by unfavorable foreign exchange impact Note: Inventor
Slide 18: KYPROLIS Sales Increased 10% YoY
KYPROLIS® Sales Increased 10% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 10%, primarily Total Change 10% 1% ROW Units 8% 0% driven by 8% volume growth U.S. Inventory 3% 1% Note: Inventory represents wholesaler inventories. Provided October 31, 2023, as part of an oral
Slide 19: LUMAKRAS/LUMYKRAS Delivered $52M of Sales
LUMAKRAS®/LUMYKRAS™ Delivered $52M of Sales $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales decreased 31%, primarily Total Change (31%) (32%) ROW Units 1% (5%) driven by unfavorable changes to U.S. Inventory (5%) 2% estimated sales deductions related to ongoing reimbursement negotiations
Slide 20: XGEVA Sales Increased 5% YoY
XGEVA® Sales Increased 5% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 5%, driven by Total Change 5% (2%) ROW Units (2%) (3%) higher net selling price* U.S. Inventory 2% 0% Note: Inventory represents wholesaler inventories. *Net selling price represents the impact of lis
Slide 21: Nplate Sales Increased 45% YoY
Nplate® Sales Increased 45% YoY $ Millions, Net Sales Highlights Q3 ’23 YoY QoQ • YoY sales increased 45%, driven by 43% Total Change 45% 35% ROW Units 43% 34% volume growth resulting from a $142 U.S. government order U.S. Inventory 1% 0% million order from the U.S. government Note: Inventory repres
Slide 22: Established Products Generated $592M of Sales and Delivered Strong Cash Flows
Established Products Generated $592M of Sales and Delivered Strong Cash Flows $ Millions, Net Sales Highlights Q3 '23 YoY QoQ • Includes EPOGEN®, Aranesp®, Parsabiv® Total Change (30%) (21%) ROW Units (13%) (6%) and Neulasta® U.S. Inventory 3% 2% • YoY sales decreased 30%, driven by lower net sellin
Slide 23: R&D Update
R&D Update
Slide 24: General Medicine
General Medicine Maridebart cafraglutide (AMG 133) – multispecific GIPR inhibitor and GLP-1 receptor agonist • A Phase 2 study in overweight or obese adults with or without type 2 diabetes mellitus has completed enrollment with topline data anticipated in late 2024. AMG 786 – small molecule obesity
Slide 25: General Medicine (continued)
General Medicine (continued) Olpasiran (AMG 890) – potentially best-in-class Lp(a) siRNA molecule • Phase 3 cardiovascular outcomes study in patients with ASCVD and elevated Lp(a) continues to enroll patients. • Data were presented from the final analysis of the Phase 2 OCEAN(a)- DOSE study. Results
Slide 26: General Medicine (continued)
General Medicine (continued) Repatha® (evolocumab) – monoclonal antibody targeting PCSK9 • New data from the FOURIER OLE study reinforcing the safety and efficacy of Repatha®, including results from the evaluation of long-term neurocognitive safety in ASCVD patients treated with Repatha®, will be pr
Slide 27: Inflammation
Inflammation TEZSPIRE® (tezepelumab-ekko) – monoclonal antibody targeting TSLP • In severe asthma: – WAYFINDER Phase 3b study is fully enrolled. – PASSAGE Phase 4 real-world effectiveness study and the SUNRISE Phase 3 study continue to enroll patients. • Studies in additional indications: – Phase 3
Slide 28: Inflammation (continued)
Inflammation (continued) Rocatinlimab (AMG 451/KHK4083) – first-in-class monoclonal antibody targeting OX40 • Post-hoc analysis data from the Phase 2b study of rocatinlimab in patients with moderate to severe atopic dermatitis were presented including PRO data demonstrating the benefit of rocatinlim
Slide 29: Inflammation (continued)
Inflammation (continued) Otezla® (apremilast) – small molecule PDE4 inhibitor • Results were presented from the DISCREET Phase 3 study which demonstrated that Otezla® treated patients across subgroups experienced greater improvement in genital psoriasis and genital itch at week 16 compared to placeb
Slide 30: Inflammation (continued)
Inflammation (continued) TAVNEOS® (avacopan) – small molecule complement 5a receptor antagonist • Data will be presented from the ADVOCATE study at the American College of Rheumatology and American Society of Nephrology Scientific sessions in November on the efficacy and safety of TAVNEOS® in key su
Slide 31: Inflammation (continued)
Inflammation (continued) Efavaleukin alfa (AMG 592) – IL-2 mutein Fc fusion protein • A Phase 2b study in ulcerative colitis continues to enroll patients. Ordesekimab (AMG 714/PRV-015) – monoclonal antibody targeting IL-15 • A Phase 2b study in nonresponsive celiac disease continues to enroll patien
Slide 32: Oncology/Hematology
Oncology/Hematology Tarlatamab (AMG 757) – first-in-class HLE BiTE® molecule targeting DLL3 • Phase 2 DeLLphi-301 data were presented and simultaneously published in the New England Journal of Medicine. In patients with advanced-stage SCLC, tarlatamab demonstrated an ORR (primary endpoint) of 40% (9
Slide 33: Oncology/Hematology (continued)
Oncology/Hematology (continued) Tarlatamab (AMG 757) – first-in-class HLE BiTE® molecule targeting DLL3 • Comprehensive global clinical development program: – DeLLphi-304, a Phase 3 study in second-line SCLC, is enrolling patients. – Plan to initiate two additional Phase 3 studies in earlier lines o
Slide 34: Oncology/Hematology (continued)
Oncology/Hematology (continued) BLINCYTO® (blinatumomab) – BiTE® molecule targeting CD19 • Based upon the E1910 study, the FDA granted Breakthrough Therapy Designation to BLINCYTO® for the treatment of adult and pediatric patients with CD19-positive, Ph-, B-ALL during the consolidation phase of mult
Slide 35: Oncology/Hematology (continued)
Oncology/Hematology (continued) BLINCYTO® (blinatumomab) – BiTE® molecule targeting CD19 • NCCN Guidelines®1 for Pediatric ALL were updated to broaden the recommendation for BLINCYTO® as consolidation to include both early and late first relapse patients with bone marrow relapse with or without extr
Slide 36: Oncology/Hematology (continued)
Oncology/Hematology (continued) Xaluritamig (AMG 509) – first-in-class bispecific molecule targeting STEAP1 • Initial Phase 1b data were presented and simultaneously published in Cancer Discovery demonstrating encouraging anti-tumor activity in heavily pretreated patients with mCRPC. – Efficacy was
Slide 37: Oncology/Hematology (continued)
Oncology/Hematology (continued) AMG 193 – first-in-class small molecule MTA-cooperative PRMT5 inhibitor • Initial results from a Phase 1/1b study demonstrate promising monotherapy activity across six MTAP-null tumor types. Dose-limiting adverse events and treatment discontinuations were typically du
Slide 38: Oncology/Hematology (continued)
Oncology/Hematology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • Data were presented and simultaneously published in the New England Journal of Medicine from the CodeBreaK 300 trial evaluating LUMAKRAS® (960 mg or 240 mg) in combination with Vectibix®. – Both do
Slide 39: Oncology/Hematology (continued)
Oncology/Hematology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • Planning to initiate a Phase 3 study of LUMAKRAS® in combination with Vectibix® and FOLFIRI in first-line KRAS G12C-mutated CRC. • Phase 1b data were presented evaluating LUMAKRAS® with carboplatin
Slide 40: Oncology/Hematology (continued)
Oncology/Hematology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • Regulatory review by the FDA and the EMA of the CodeBreaK 200 Phase 3 trial of previously treated patients with KRAS G12C-mutated advanced NSCLC along with data from the Phase 2 dose comparison sub
Slide 41: Oncology/Hematology (continued)
Oncology/Hematology (continued) Bemarituzumab – first-in-class monoclonal antibody targeting FGFR2b • Studies in first-line gastric cancer enrolling patients: – FORTITUDE-101, a Phase 3 study of bemarituzumab in combination with chemotherapy – FORTITUDE-102, a Phase 1b/3 study of bemarituzumab in co
Slide 42: Biosimilars
Biosimilars ABP 206, an investigational biosimilar to OPDIVO ® (nivolumab) • The clinical comparative study portion of a randomized, double-blind pivotal study evaluating PK similarity of ABP 206 compared with OPDIVO® (nivolumab) in resected stage III or stage IV melanoma patients in the adjuvant se
Slide 43: Q3 '23 Business Results and Outlook
Q3 ’23 Business Results and Outlook
Slide 44: Q3 '23 Financial Results
Q3 '23 Financial Results $ Millions, Except Non-GAAP EPS Item Q3 ’23 Q3 ’22 B/(W) % Revenue $6,903 $6,652 4% Product Sales 6,548 6,237 5% Other Revenues 355 415 (14%) Non-GAAP Operating Expenses 3,500 3,375 (4%) Cost of Sales % of product sales 1,137 17.4 % 1,003 16.1 % (13%) R&D % of product sales
Slide 45: Strong Balance Sheet With Free Cash Flow of $2.5B in Q3 '23
Strong Balance Sheet With Free Cash Flow of $2.5B in Q3 '23 $ Billions, Except Dividends Paid Per Share Cash Flow Data Q3 ’23 Q3 ’22 Capital Expenditures $0.2 $0.2 Free Cash Flow* 2.5 2.8 Share Repurchases 0.0 0.0 YoY Dividend Increase 10% 10% Dividends Paid Per Share $2.13 $1.94 Balance Sheet Data
Slide 46: 2023 Guidance
2023 Guidance Guidance Comments Revised from Revenue $28.0B – $28.4B $26.6B – $27.4B Revised from Non-GAAP EPS* $18.20 – $18.80 $17.80 – $18.80 Revised from Non-GAAP Tax Rate* 16.5% – 17.0% 17.5% – 18.5% Capital Expenditures ~ $950M ~ $925M *Non-GAAP financial measure—if this slide is in hard copy,
Slide 47: Q3 '23 Earnings Call
Q3 ’23 Earnings Call October 31, 2023
Slide 48: Reconciliations
Reconciliations
Slide 49: Consolidated Statements of Income - GAAP
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per - share data) (Unaudited) Three months ended Nine months ended September 30, September 30, 2023 2022 2023 2022 Revenues: Product sales $ 6,548 $ 6,237 $ 19,077 $ 18,249 Other revenues 355 415 917 1,235 Total revenues 6,903
Slide 50: Consolidated Balance Sheets - GAAP
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) September 30, December 31, 2023 2022 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $ 34,741 $ 9,305 Trade receivables, net 6,145 5,563 Inventories 5,026 4,930 Other current assets 2,565 2,388 Total curr
Slide 51: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars In millions) (Unaudited) Provided October 31, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 51 materially; Amgen disclaims any duty to update.
Slide 52: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited) (Continued from previous slide) The following table presents the computations for GAAP and non-GAAP diluted earnings per share: Three months ended Three months ended September 30, 2023 September 30, 2022 GAA
Slide 53: Reconciliations of Cash Flows
Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended Nine months ended September 30, September 30, 2023 2022 2023 2022 Net cash provided by operating activities $ 2,760 $ 2,978 $ 7,933 $ 7,072 Net cash provided by (used in) investing activities (262) (267) 885 (2,571
Slide 54: Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance
Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2023 (Unaudited) GAAP diluted EPS guidance $ 11.23 — $ 12.73 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 7.60 — 8.35 Net charges related to restructuring and cost s
Slide 55: Q3 '23 Earnings Call
Q3 ’23 Earnings Call October 31, 2023