Slide 1: Q4 '23 Earnings Call
Q4 ’23 Earnings Call February 6, 2024
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 Jay Bradner Q4 ’23 and FY ’23 Results and Outlook Peter Griffith Q&A All Provided February 6, 2024, as part of an oral presentation and
Slide 4: 2023: Another Year of Performance and Progress Toward Our Long-Term Objectives
2023: ANOTHER YEAR OF PERFORMANCE AND PROGRESS TOWARD OUR LONG-TERM OBJECTIVES • Delivered volume-driven growth, with record sales for 18 brands1 • Advanced our pipeline of innovative, potentially first-in-class medicines • Created a rare disease pillar to include Horizon and TAVNEOS® • Delivered at
Slide 5: Global Commercial Update
Global Commercial Update
Slide 6: Q4 '23 Global Commercial Update
Q4 ’23 Global Commercial Update Q4 ’23 Q4 ’22 YoY $ Millions, Net Sales U.S. ROW Total Total Total Repatha® 201 216 417 333 25% Prolia® 746 361 1,107 992 12% EVENITY® 239 79 318 225 41% Aimovig® 73 5 78 114 (32%) BLINCYTO® 148 93 241 164 47% Vectibix® 116 135 251 238 5% KYPROLIS® 222 128 350 325 8%
Slide 7: Product Sales Grew 20% YoY in Q4, Driven by 23% Volume Growth
Product Sales Grew 20% YoY in Q4, Driven by 23% Volume Growth $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • Record quarterly sales of nine products1 Total Change 20% 20% ROW Units 23% 18% • Repatha®, EVENITY®, Prolia®, and U.S. Inventory 0% 2% BLINCYTO® delivered double-digit volume growth globa
Slide 8: Repatha Volume Grew 35% YoY in Q4
Repatha® Volume Grew 35% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • Global leader in PCSK9 segment Total Change 25% 3% ROW Units 35% 1% • YoY sales increased 25% for the quarter U.S. Inventory 0% 0% and 26% for the full year, driven by 35% and 37% volume growth, respectively, partia
Slide 9: Prolia Achieved Record Sales in Q4
Prolia® Achieved Record Sales in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 12% for the quarter Total Change 12% 12% ROW Units 10% 11% and full year, primarily driven by U.S. Inventory (1%) 1% volume growth and higher net selling price* • YoY volume grew 10% for the qua
Slide 10: EVENITY Achieved Record Sales in Q4
EVENITY® Achieved Record Sales in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 41% for the quarter Total Change 41% 4% ROW Units 39% 6% and 47% for the full year, driven by U.S. Inventory (1%) (3%) strong volume growth • Full year U.S. volume grew 44% YoY • Full year ex-U
Slide 11: BLINCYTO Achieved Record Sales in Q4
BLINCYTO® Achieved Record Sales in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 47% for the quarter Total Change 47% 10% ROW Units 55% 7% and 48% for the full year, driven by 55% U.S. Inventory (1%) (2%) and 49% volume growth, respectively • Volume growth was supported by
Slide 12: Vectibix Sales Increased 5% YoY in Q4
Vectibix® Sales Increased 5% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 5% for the quarter Total Change 5% 0% ROW Units 5% 0% and 10% for the full year, driven by 5% U.S. Inventory (1%) (1%) and 10% volume growth, respectively Note: Inventory represents wholesale
Slide 13: KYPROLIS Sales Increased 8% YoY in Q4
KYPROLIS® Sales Increased 8% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 8% for the quarter Total Change 8% 0% ROW Units 8% 1% and 13% for the full year, driven by 8% U.S. Inventory 1% 1% and 12% volume growth, respectively Note: Inventory represents wholesaler in
Slide 14: LUMAKRAS/LUMYKRAS Sales Increased 8% YoY in Q4
LUMAKRAS®/LUMYKRAS™ Sales Increased 8% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 8% for the quarter, Total Change 8% 48% ROW Units 5% 20% driven by 5% volume growth and higher U.S. Inventory 2% 13% net selling price* • YoY sales decreased 2% for the full year, d
Slide 15: XGEVA Sales Increased 9% YoY in Q4
XGEVA® Sales Increased 9% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 9% for the quarter Total Change 9% 2% ROW Units 0% 0% and 5% for the full year, primarily driven U.S. Inventory 1% 1% by higher net selling price* Note: Inventory represents wholesaler inventori
Slide 16: Nplate Sales Increased 13% in 2023
Nplate® Sales Increased 13% in 2023 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales decreased 18% for the Total Change (18%) (8%) U.S. government orders Units (18%) (10%) quarter, driven by volume decline U.S. ROW Inventory 0% 0% related to timing of orders placed by the U.S. government,
Slide 17: TEZSPIRE Volume Grew 18% QoQ in Q4
TEZSPIRE® Volume Grew 18% QoQ in Q4 $ Millions, Net Sales Highlights Q4 ’23 QoQ • 18% QoQ volume growth benefited from Total Change 10% Units 18% the pre-filled, single-use pen that was U.S. Inventory (1%) approved in Q1 ’23 • TEZSPIRE®'s unique, differentiated profile has broad potential to treat 2
Slide 18: Otezla Volume Grew 3% YoY in Q4
Otezla® Volume Grew 3% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 2% for the quarter, driven Total Change 2% 11% by favorable changes to estimated sales ROW Units 3% 1% U.S. deductions and 3% volume growth, partially Inventory (3%) 8% offset by lower inventory le
Slide 19: Enbrel U.S. Volume Grew 1% YoY in Q4
Enbrel® U.S. Volume Grew 1% YoY in Q4 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales decreased 8% for the quarter, Total Change (8%) (2%) driven by a 4% impact from unfavorable ROW Units 0% 1% U.S. changes to estimated sales deductions and Inventory (1%) 6% lower net selling price* • Yo
Slide 20: AMGEVITA Ex-U.S. Volume Grew 20% YoY in 2023
AMGEVITA™ Ex-U.S. Volume Grew 20% YoY in 2023 $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • YoY sales increased 34% for the quarter Total Change 34% 5% ROW Units 35% (6%) and 36% for the full year, primarily U.S. Inventory 5% 7% driven by 35% and 46% volume growth, respectively • Full year ex-U.
Slide 21: TEPEZZA Delivered $448M of Sales
TEPEZZA® Delivered $448M of Sales Highlights • Added through our Horizon Therapeutics acquisition completed on Oct. 6, 2023 • Sales reflect Oct. 6–Dec. 31 period only • TEPEZZA® is the first and only FDA- approved treatment for thyroid eye disease (TED) Note: Inventory represents wholesaler inventor
Slide 22: KRYSTEXXA Delivered $272M of Sales
KRYSTEXXA® Delivered $272M of Sales Highlights • Added through our Horizon Therapeutics acquisition completed on Oct. 6, 2023 • Sales reflect Oct. 6–Dec. 31 period only • KRYSTEXXA® is the first and only FDA- approved treatment for chronic refractory gout Note: Inventory represents wholesaler invent
Slide 23: UPLIZNA Delivered $65M of Sales
UPLIZNA® Delivered $65M of Sales Highlights • Added through our Horizon Therapeutics acquisition completed on Oct. 6, 2023 • Sales reflect Oct. 6–Dec. 31 period only • UPLIZNA® is used to treat adults with neuromyelitis optica spectrum disorders (NMOSD) Note: Inventory represents wholesaler inventor
Slide 24: TAVNEOS Sales Increased 19% QoQ in Q4
TAVNEOS® Sales Increased 19% QoQ in Q4 $ Millions, Net Sales Highlights Q4 ’23 QoQ • QoQ sales increased 19%, primarily Total Change 19% ROW Units 17% driven by volume growth U.S. Inventory 3% • U.S. volume grew 23% QoQ • In the U.S., approximately 2,700 patients 2 have now been treated with TAVNEOS
Slide 25: Established Products Generated $702M of Sales and Delivered Strong Cash Flows
Established Products Generated $702M of Sales and Delivered Strong Cash Flows $ Millions, Net Sales Highlights Q4 ’23 YoY QoQ • Established products consist of EPOGEN®, Total Change (10%) 19% Aranesp®, Parsabiv®, and Neulasta® ROW Units (4%) 5% U.S. Inventory (2%) (3%) • Q4 YoY sales decreased 10%,
Slide 26: R&D Update
R&D Update
Slide 27: 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. Recently added a Part 2 to this
Slide 28: General Medicine (continued)
General Medicine (continued) AMG 786 – small molecule obesity program (target not disclosed) • A Phase 1 study is ongoing, with initial data readout anticipated in H1 2024. • This molecule has a different target than maridebart cafraglutide and is not an incretin-based therapy. Olpasiran (AMG 890) –
Slide 29: General Medicine (continued)
General Medicine (continued) Repatha® (evolocumab) – monoclonal antibody targeting PCSK9 • EVOLVE-MI, a Phase 4 study of Repatha® administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, continues to enroll patients. • A Phase 3 cardiovascular outcomes study (VE
Slide 30: Oncology
Oncology Tarlatamab (AMG 757) – first-in-class HLE BiTE® molecule targeting DLL3 • The FDA has granted Priority Review for the Company’s BLA based on results from the Phase 2 DeLLphi-301 clinical trial in previously treated SCLC. • Based on the Priority Review designation, the PDUFA date for tarlata
Slide 31: Oncology (continued)
Oncology (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, continues to enroll patients. – DeLLphi-306, a Phase 3 study in limited-stage SCLC, was initiated. – D
Slide 32: Oncology (continued)
Oncology (continued) Tarlatamab (AMG 757) – first-in-class HLE BiTE® molecule targeting DLL3 • Comprehensive global clinical development program: – 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 Phas
Slide 33: Oncology (continued)
Oncology (continued) BLINCYTO® (blinatumomab) – BiTE® molecule targeting CD19 • The FDA granted Priority Review for the Company’s supplemental BLA for BLINCYTO® in early-stage, CD19-positive B-ALL based in part on the Phase 3 E1910 study conducted by NCI and the ECOG-ACRIN Cancer Research Group. • B
Slide 34: Oncology (continued)
Oncology (continued) BLINCYTO® (blinatumomab) – BiTE® molecule targeting CD19 • Golden Gate, a Phase 3 study of BLINCYTO® alternating with low- intensity chemotherapy in older adults with newly diagnosed Ph- B-ALL, continues to enroll patients. • The Company is planning to amend the Golden Gate Phas
Slide 35: Oncology (continued)
Oncology (continued) Xaluritamig (AMG 509) – first-in-class bispecific T-cell engager targeting STEAP1 • A Phase 1b monotherapy and combination dose-escalation and -expansion study in mCRPC continues to enroll patients in the dose- expansion portion of the study, where enrollment is almost complete.
Slide 36: Oncology (continued)
Oncology (continued) AMG 193 – first-in-class small molecule MTA-cooperative PRMT5 inhibitor • This Phase 1/1b/2 study continues to enroll patients with advanced MTAP-null solid tumors. To date, responses have been seen in nine patients across seven tumor types. • Master protocols in thoracic and ga
Slide 37: Oncology (continued)
Oncology (continued) Nplate® (romiplostim) – a fusion protein analog of thrombopoietin • 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. Provided February 6, 202
Slide 38: Oncology (continued)
Oncology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • A U.S. regulatory submission is planned for the Phase 3 CodeBreaK 300 trial in H1 2024. This study evaluated two doses of LUMAKRAS (960 mg or 240 mg) in combination with Vectibix® in patients with chemorefrac
Slide 39: Oncology (continued)
Oncology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • A Phase 3 study of LUMAKRAS® plus chemotherapy vs. pembrolizumab plus chemotherapy in first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC is enrolling patients. • Regulatory review by the EMA of th
Slide 40: Oncology (continued)
Oncology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • The FDA completed its review of the Company’s supplemental NDA seeking full approval of LUMAKRAS® based on the CodeBreaK 200 trial results. The FDA: – Issued a new postmarketing requirement for an additional
Slide 41: Oncology (continued)
Oncology (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 combination
Slide 42: 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 43: Inflammation (continued)
Inflammation (continued) Rocatinlimab (AMG 451/KHK4083) – first-in-class monoclonal antibody targeting OX40 • The ROCKET Phase 3 program, now composed of eight studies evaluating rocatinlimab in moderate to severe atopic dermatitis, continues to enroll adult and adolescent patients. – To date, over
Slide 44: Inflammation (continued)
Inflammation (continued) Otezla® (apremilast) – small molecule PDE4 inhibitor • In Nov 2023, data were presented: • In the MOSAIC Phase 4 study, primary and key secondary outcomes highlighted that Otezla® led to better inflammatory disease control in psoriatic arthritis patients with moderate clinic
Slide 45: 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 has completed enrollment.
Slide 46: Rare Disease
Rare Disease TAVNEOS® (avacopan) – small molecule complement 5a receptor antagonist • In Nov 2023, data were presented from the Phase 3 ADVOCATE trial demonstrating that outcomes in patients with ANCA-associated vasculitis favored TAVNEOS® versus a prednisone taper across subgroups of patients 65 ye
Slide 47: Rare Disease (continued)
Rare Disease (continued) TEPEZZA® (teprotumumab-trbw) – monoclonal antibody targeting IGF-1R • In Dec 2023, TEPEZZA® received orphan drug designation in Japan for patients with moderate to severe active thyroid eye disease. • An NDA was submitted for TEPEZZA® in Japan based on the results from the O
Slide 48: Rare Disease (continued)
Rare Disease (continued) UPLIZNA® (inebilizumab-cdon) – monoclonal antibody targeting CD19 • A Phase 3 study in myasthenia gravis is fully enrolled. Data readout is anticipated in H2 2024. • A Phase 3 study for the prevention of flare in IgG4-related disease is fully enrolled. Data readout is antici
Slide 49: Rare Disease (continued)
Rare Disease (continued) Dazodalibep – CD40 ligand inhibitor fusion protein • A Phase 3 study in Sjögren’s syndrome is enrolling patients. Daxdilimab – monoclonal antibody targeting ILT7 • A Phase 2 study in moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care
Slide 50: Rare Disease (continued)
Rare Disease (continued) Fipaxalparant (formerly AMG 670 / HZN 825) – a small molecule targeting LPAR1 • A Phase 2 study in idiopathic pulmonary fibrosis is enrolling patients. Data readout is anticipated in H2 2024. • A Phase 2 study in diffuse cutaneous systemic sclerosis is enrolling patients. LP
Slide 51: 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® in resected stage III or stage IV melanoma patients in the adjuvant setting is enr
Slide 52: Important Pipeline Milestones Anticipated in 2024
IMPORTANT PIPELINE MILESTONES ANTICIPATED IN 2024 GENERAL ONCOLOGY INFLAMMATION Y RARE DISEASE MEDICINE • MariTide Phase 2 • Tarlatamab PDUFA date 6/12/24 • TEZSPIRE® Phase 2 COPD ✓TEPEZZA® Japan submission data readout late 2024 • Tarlatamab Phase 3 study in 1L ES- data readout H1 2024 H1 2024 SCLC
Slide 53: Q4 '23 and FY '23 Business Results and Outlook
Q4 ’23 and FY ’23 Business Results and Outlook
Slide 54: Q4 '23 Financial Results
Q4 ’23 Financial Results $ Millions, Except Non-GAAP EPS Item Q4 ’23 Q4 ’22 B/(W) % Revenue $8,196 $6,839 20% Product Sales 7,833 6,552 20% Other Revenues 363 287 26% Non-GAAP Operating Expenses 4,536 3,830 (18%) Cost of Sales % of product sales 1,278 16.3 % 1,071 16.3 % (19%) R&D % of product sales
Slide 55: FY 2023 Financial Results
FY 2023 Financial Results $ Millions, Except Non-GAAP EPS Item FY ’23 FY ’22 B/(W) % Revenue $28,190 $26,323 7% Product Sales 26,910 24,801 9% Other Revenues 1,280 1,522 (16%) Non-GAAP Operating Expenses 14,791 13,562 (9%) Cost of Sales % of product sales 4,573 17.0 % 3,951 15.9 % (16%) R&D % of pro
Slide 56: Strong Balance Sheet With Free Cash Flows of $0.3B in Q4 '23
Strong Balance Sheet With Free Cash Flows of $0.3B in Q4 '23 $ Billions, Except Dividends Paid Per Share Cash Flow Data Q4 ’23 Q4 ’22 Capital Expenditures $0.2 $0.3 Free Cash Flow* 0.3 2.3 Share Repurchases – – YoY Dividend Increase 10% 10% Dividends Paid Per Share $2.13 $1.94 Balance Sheet Data 12/
Slide 57: 2024 Guidance
2024 Guidance Guidance Revenue $32.4B – $33.8B Non-GAAP EPS* $18.90 – $20.30 Non-GAAP Tax Rate* 16.0% – 17.0% Capital Expenditures ~ $1.1B *Non-GAAP financial measure—if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, or am
Slide 58: Q4 '23 Earnings Call
Q4 ’23 Earnings Call February 6, 2024
Slide 59: Reconciliations
Reconciliations
Slide 60: Consolidated Statements of Income - GAAP
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) Three months ended Twelve months ended (Unaudited) December 31, December 31, 2023 2022 2023 2022 Revenues: Product sales $ 7,833 $ 6,552 $ 26,910 $ 24,801 Other revenues 363 287 1,280 1,522 Total revenues 8,196
Slide 61: Consolidated Balance Sheets - GAAP
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) December 31, December 31, 2023 2022 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $ 10,944 $ 9,305 Trade receivables, net 7,268 5,563 Inventories 9,518 4,930 Other current assets 2,602 2,388 Total curre
Slide 62: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars In millions) (Unaudited) Provided February 6, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 62 materially; Amgen disclaims any duty to update.
Slide 63: GAAP to Non-GAAP Reconciliations (EPS)
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 December 31, 2023 December 31, 2022 GAAP
Slide 64: Reconciliations of Cash Flows
Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended Twelve months ended December 31, December 31, 2023 2022 2023 2022 Net cash provided by operating activities $ 538 $ 2,649 $ 8,471 $ 9,721 Net cash used in investing activities (27,089) (3,473) (26,204) (6,044) Net
Slide 65: Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio
Amgen Inc. Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio Calculation (In millions) (Unaudited) Twelve months ended December 31, 2023 GAAP Net Income $ 6,717 Depreciation and amortization 4,071 Interest expense, net 2,875 Provision for income taxes 1,138 EBITDA(a) $ 14,801 As of
Slide 66: 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, 2024 (Unaudited) GAAP diluted EPS guidance $ 8.42 — $ 9.87 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 10.43 — 10.48 Non-GAAP diluted EPS guidance $ 18.90 — $ 20.30
Slide 67: Q4 '23 Earnings Call
Q4 ’23 Earnings Call February 6, 2024