Slide 1: Q1 '23 Earnings Call
Q1 ’23 Earnings Call April 27, 2023
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, o
Slide 3: Agenda
Agenda Introduction Arvind Sood Opening Remarks Bob Bradway Global Commercial Update Murdo Gordon Research & Development Update David Reese Q1 ’23 Results and Outlook Peter Griffith Q&A All Provided April 27, 2023, as part of an oral presentation and is qualified by such, contains forward-looking st
Slide 4: We Are Raising Our Full Year Outlook, Based On First Quarter Momentum
We Are Raising Our Full Year Outlook, Based On First Quarter Momentum • Delivered 14% volume growth, with record sales for 10 brands • Expect to close announced acquisition of Horizon Therapeutics plc in the first half of this year • Expanded our international footprint, with 22% ex-U.S. volume grow
Slide 5: Global Commercial Update
Global Commercial Update
Slide 6: Q1 '23 Global Commercial Update
Q1 ’23 Global Commercial Update Q1 ’23 Q1 ’22 YoY $ Millions, Net Sales U.S. ROW Total Total Total Repatha® 197 191 388 329 18% Prolia® 623 304 927 852 9% EVENITY® 164 90 254 170 49% Aimovig® 64 5 69 101 (32%) TEZSPIRE® 96 — 96 7 * TAVNEOS® 23 — 23 — NM Otezla® 294 98 392 451 (13%) Enbrel® 564 15 57
Slide 7: Product Sales Grew 2% YoY in Q1 '23, Driven by 14% Volume Growth
Product Sales Grew 2% YoY in Q1 ’23, Driven by 14% Volume Growth $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ • Record quarterly sales for 10 products Total Change 2% (11%) ROW Units 14% 0% • Double-digit volume growth from EVENITY®, U.S. Inventory (2%) (7%) BLINCYTO®, Nplate®, LUMAKRAS®/LUMYKRAS
Slide 8: Repatha Achieved Record Quarterly Sales
Repatha® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ • Global PCSK9 segment leader Total Change 18% 17% ROW Units 33% 8% • YoY sales increased 18%, driven by 33% U.S. Inventory (2%) (2%) volume growth, partially offset by lower net selling price* • U.S. sales grew
Slide 9: Prolia Volume Grew 8% YoY in Q1
Prolia® Volume Grew 8% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 9% (7%) • YoY sales increased 9%, driven by 8% ROW Units 8% (3%) volume growth U.S. Inventory (1%) (4%) Note: Inventory represents wholesaler inventories. Provided April 27, 2023, as part of an oral present
Slide 10: EVENITY Achieved Record Quarterly Sales
EVENITY® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 49% 13% • YoY sales increased 49%, primarily ROW Units 55% 15% driven by volume growth U.S. Inventory 1% (3%) • U.S. volumes grew 43% and ex-U.S. volumes grew 77% • Complements Prolia® in our Bone p
Slide 11: TEZSPIRE Sales Increased 22% QoQ in Q1
TEZSPIRE® Sales Increased 22% QoQ in Q1 $ Millions, Net Sales Highlights Q1 ’23 QoQ • Continued strong adoption in the U.S. by Total Change 22% Units 28% allergists and pulmonologists U.S. Inventory (7%) • Healthcare providers appreciate the unique, differentiated profile of TEZSPIRE® and its broad
Slide 12: TAVNEOS Delivered $23M of Sales in Q1
TAVNEOS® Delivered $23M of Sales in Q1 $ Millions, Net Sales Highlights Q1 ’23 QoQ • QoQ sales increased 10%, driven by Total Change 10% ROW Units (4%) higher net selling price* and inventory U.S. Inventory 3% levels, partially offset by lower ex-U.S. volume driven by the timing of shipments to our
Slide 13: Otezla Volume Grew 5% YoY in Q1
Otezla® Volume Grew 5% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ • YoY sales decreased 13%, driven by Total Change (13%) (36%) ROW Units 5% (1%) lower inventory levels and net selling U.S. Inventory (9%) (28%) price*, partially offset by 5% volume growth • U.S. new patient demand is
Slide 14: Enbrel U.S. Volume Grew 1% YoY in Q1
Enbrel® U.S. Volume Grew 1% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ • U.S. volumes grew 1% YoY, supported Total Change (33%) (47%) ROW Units 0% (3%) by improved payor coverage U.S. Inventory (12%) (21%) • YoY sales decreased 33%, driven by decline in net selling price*, lower 20 in
Slide 15: AMJEVITA/AMGEVITA Achieved Record Quarterly Sales
AMJEVITA®/AMGEVITA™ Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 52% 38% • YoY sales increased 52%, driven by ROW Units 35% 7% higher inventory levels and 35% volume U.S. Inventory 39% 35% growth, partially offset by unfavorable foreign exchange impact
Slide 16: BLINCYTO Achieved Record Quarterly Sales
BLINCYTO® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 41% 18% • YoY sales increased 41%, driven by 49% ROW Units 49% 33% volume growth U.S. Inventory (1%) (1%) • Volume growth was supported by strong adoption across academic and community centers Note
Slide 17: Vectibix Sales Increased 16% YoY in Q1
Vectibix® Sales Increased 16% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 16% (2%) • YoY sales increased 16%, driven by 15% ROW Units 15% (4%) volume growth U.S. Inventory 0% (1%) • Volume growth was supported by positive data from the Phase 3 PARADIGM trial demonstrating
Slide 18: KYPROLIS Achieved Record Quarterly Sales
KYPROLIS® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 25% 10% • YoY sales increased 25%, driven by 18% ROW Units 18% 2% volume growth, higher net selling price*, U.S. Inventory 0% (1%) and strong global execution Note: Inventory represents wholesaler
Slide 19: LUMAKRAS/LUMYKRAS Is Approved in Over 50 Countries
LUMAKRAS®/LUMYKRAS™ Is Approved in Over 50 Countries $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 19% 4% • YoY sales increased 19%, driven by 40% ROW Units 40% (5%) volume growth, partially offset by lower U.S. Inventory 3% (3%) net selling price* • Ex-U.S., LUMYKRASTM has been appro
Slide 20: XGEVA Sales Increased 7% YoY in Q1
XGEVA® Sales Increased 7% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 7% 11% • YoY sales increased 7%, driven by ROW Units 4% 4% higher net selling price* and 4% volume U.S. Inventory 0% (2%) growth Note: Inventory represents wholesaler inventories. *Net selling price repr
Slide 21: Nplate Sales Increased 36% YoY in Q1
Nplate® Sales Increased 36% YoY in Q1 $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change 36% (23%) • YoY sales increased 36%, driven by ROW Units 41% (21%) volume growth U.S. Inventory (1%) (1%) • Q1 sales included $82 million related to an order from the U.S. government • Q4 sales include
Slide 22: MVASI Generated $202M Of Q1 Sales
MVASI® Generated $202M Of Q1 Sales $ Millions, Net Sales Highlights Q1 ’23 YoY QoQ Total Change (17%) (1%) • YoY sales decreased 17%, driven by ROW Units 15% 10% lower net selling price*, partially offset U.S. Inventory 2% 1% by 15% volume growth • Expect continued net selling price* erosion, driven
Slide 23: Established Products Generated $755M of Q1 Sales
Established Products Generated $755M of Q1 Sales and Continued to Deliver Strong Cash Flows $ Millions, Net Sales Q1 ’23 Highlights Q1 '23 YoY QoQ • Includes EPOGEN®, Aranesp®, Parsabiv®, Total Change (17%) (3%) and Neulasta® ROW Units (2%) (3%) U.S. Inventory (1%) (3%) • YoY sales decreased 17%, dr
Slide 24: R&D Update
R&D Update
Slide 25: Q1 '23 Earnings Call – R&D Update: General Medicine
Q1 ‘23 Earnings Call – R&D Update General Medicine • Olpasiran (AMG 890) – Lipoprotein(a) siRNA molecule – A Phase 3 cardiovascular outcomes study in participants with ASCVD and elevated Lp(a), continues to enroll. – A new analysis from the OCEAN(a) Phase 2 Dose study was presented, demonstrating th
Slide 26: R&D Update: General Medicine (continued)
Q1 ‘23 Earnings Call – R&D Update General Medicine (continued) • 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, continues to enroll. • AMG 786 – small-molecule obesity program (target not di
Slide 27: R&D Update: General Medicine (continued)
Q1 ‘23 Earnings Call – R&D Update General Medicine (continued) • Prolia® - monoclonal antibody targeting RANK Ligand – In May, the Company will present results of the largest head-to-head, real-world study in postmenopausal osteoporosis, comparing fracture risk reduction of Prolia ® with bisphosphon
Slide 28: R&D Update: Inflammation
Q1 ‘23 Earnings Call – R&D Update Inflammation • TEZSPIRE® (tezepelumab-ekko) – monoclonal antibody targeting TSLP – In February, the FDA approved TEZSPIRE ® for self-administration in a prefilled, single-use pen for patients aged 12 years and older with severe asthma. – In severe asthma, the PASSAG
Slide 29: R&D Update: Inflammation (continued)
Q1 ‘23 Earnings Call – R&D Update Inflammation (continued) • Rocatinlimab (AMG 451 / KHK4083) – monoclonal antibody targeting OX40 – The ROCKET Phase 3 program is enrolling adult and adolescent patients with moderate to severe atopic dermatitis. • Rozibafusp alfa (AMG 570) – antibody-peptide conjuga
Slide 30: R&D Update: Oncology/Hematology
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology • BLINCYTO® – BiTE® molecule targeting CD19 – Global regulatory authority submissions are planned in H2 2023 for E1910, a Phase 3 trial conducted by the NCI and ECOG-ACRIN Cancer Research Group that demonstrated superior overall survival with BLI
Slide 31: R&D Update: Oncology/Hematology (continued)
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology (continued) • Tarlatamab (AMG 757) – HLE BiTE® molecule targeting DLL3 o DeLLphi-304, a Phase 3 study comparing tarlatamab with SOC chemotherapy in second-line SCLC, will be initiated this month. – DeLLphi-301, a potentially registrational Phase
Slide 32: R&D Update: Oncology/Hematology (continued)
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology (continued) • Bemarituzumab – monoclonal antibody targeting FGFR2b – FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy in first-line gastric cancer, continues to enroll patients. – FORTITUDE-102, a Phase 1b/3 study of bemarituzuma
Slide 33: R&D Update: Oncology/Hematology (continued)
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology (continued) • LUMAKRAS®/LUMYKRAS™ (sotorasib) – The Company continues to investigate novel combinations and is advancing a comprehensive global clinical development program in NSCLC, CRC, and other solid tumors to further explore the potential of
Slide 34: R&D Update: Oncology/Hematology (continued)
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology (continued) • LUMAKRAS®/LUMYKRAS™ (sotorasib) – In March, the Company completed submission of the LUMAKRAS ® CodeBreak 200 Phase 3 confirmatory data, along with data from the Phase 2 dose comparison substudy, to the FDA and to the European Medici
Slide 35: R&D Update: Oncology/Hematology (continued)
Q1 ‘23 Earnings Call – R&D Update Oncology/Hematology (continued) • Xaluritamig (AMG 509) – bispecific molecule targeting STEAP1 – A Phase 1 dose-escalation/expansion study in mCRPC, continues to enroll patients. Initial data readout is anticipated in H2 2023. • AMG 340 – lower T-cell affinity BiTE®
Slide 36: R&D Update: Biosimilars
Q1 ‘23 Earnings Call – R&D Update Biosimilars • In April 2023, the European Commission (EC) granted marketing authorization for BEKEMV® (eculizumab, formerly ABP 959), a biosimilar to SOLIRIS® (eculizumab). BEKEMV® is the first biosimilar to SOLIRIS ® approved by the EC. BEKEMV® is approved only for
Slide 37: Q1 '23 Business Results and Outlook
Q1 ’23 Business Results and Outlook
Slide 38: Q1 '23 Financial Results
Q1 '23 Financial Results $ Millions, Except Non-GAAP EPS Item Q1 ’23 Q1 ’22 B/(W) % Revenue $6,105 $6,238 (2%) Product Sales 5,846 5,731 2% Other Revenues 259 507 (49%) Non-GAAP Operating Expenses 3,284 3,098 (6%) Cost of Sales % of product sales 1,016 17.4% 951 16.6% (7%) R&D % of product sales 1,0
Slide 39: Executing Multiple Capital Allocation Priorities With Strong Balance Sheet
Executing Multiple Capital Allocation Priorities With Strong Balance Sheet $ Billions, Except Dividends Paid Per Share Cash Flow Data Q1 ’23 Q1 ’22 Capital Expenditures $0.3 $0.2 Free Cash Flow* 0.7 2.0 Share Repurchases 0.0 6.3 YoY Dividend Increase 10% 10% Dividends Paid Per Share $2.13 $1.94 Bala
Slide 40: 2023 Guidance (Excludes Any Contribution From Horizon Therapeutics)
2023 Guidance (Excludes Any Contribution From Announced Acquisition of Horizon Therapeutics plc) Guidance Comments Revised from Revenue $26.2B–$27.3B $26.0B–$27.2B Revised from Non-GAAP EPS* $17.60–$18.70 $17.40–$18.60 Non-GAAP Tax Rate* 18.0%–19.0% Unchanged Capital Expenditures ~$925M Unchanged *N
Slide 41: Q1 '23 Earnings Call
Q1 ’23 Earnings Call April 27, 2023
Slide 42: Reconciliations
Reconciliations
Slide 43: Consolidated Statements of Income - GAAP
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per - share data) (Unaudited) Three months ended March 31, 2023 2022 Revenues: Product sales $ 5,846 $ 5,731 Other revenues 259 507 Total revenues 6,105 6,238 Operating expenses: Cost of sales 1,720 1,561 Research and developme
Slide 44: Consolidated Balance Sheets - GAAP
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) March 31, December 31, 2023 2022 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $ 31,561 $ 9,305 Trade receivables, net 5,736 5,563 Inventories 5,011 4,930 Other current assets 2,395 2,388 Total current
Slide 45: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars In millions) (Unaudited) Provided April 27, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 45 materially; Amgen disclaims any duty to update.
Slide 46: GAAP to Non-GAAP Reconciliations (continued)
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 March 31, 2023 March 31, 2022 GAAP Non-GA
Slide 47: Reconciliations of Cash Flows
Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended March 31, 2023 2022 Net cash provided by operating activities $ 1,064 $ 2,164 Net cash provided by (used in) investing activities 1,358 (111) Net cash provided by (used in) financing activities 21,509 (3,514) Incre
Slide 48: Reconciliation of Total Revenues and Product Sales Adjusted for FX
Amgen Inc. Reconciliation of Total Revenues and Product Sales Adjusted for Foreign Exchange (FX) Impact (Dollars in millions) (Unaudited) Three months ended March 31, Three months ended March FX impact % Change 2023 2022 Change FX impact $ (a) (a) 31, 2023 excluding FX excluding FX Product Sales $ 5
Slide 49: 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 $ 15.38 — $ 16.59 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 4.31 — 4.36 Net charges related to restructuring and cost s
Slide 50: Q1 '23 Earnings Call
Q1 ’23 Earnings Call April 27, 2023