Slide 1: Q2 ’23 Earnings Call
Q2 ’23 Earnings Call August 3, 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 Arvind Sood Opening Remarks Bob Bradway Global Commercial Update Murdo Gordon Research & Development Update David Reese Q2 ’23 Results and Outlook Peter Griffith Q&A All Provided August 3, 2023, as part of an oral presentation and is qualified by such, contains forward-looking st
Slide 4: We Achieved Record Results, Reported Positive Pipeline Data and Raised Our Full-Year Outlook
We Achieved Record Results, Reported Positive Pipeline Data and Raised Our Full-Year Outlook • Delivered record revenues and non-GAAP earnings per share • Delivered 11% volume growth, with record sales for 9 brands • Expanded our international footprint, with 16% ex-U.S. volume growth (46% in Asia P
Slide 5: Global Commercial Update
Global Commercial Update
Slide 6: Q2 ’23 Global Commercial Update
Q2 ’23 Global Commercial Update Q2 ’23 Q2 ’22 YoY $ Millions, Net Sales U.S. ROW Total Total Total Repatha® 212 212 424 325 30% Prolia® 691 337 1,028 922 11% EVENITY® 192 89 281 191 47% Aimovig® 78 4 82 92 (11%) TEZSPIRE® 133 — 133 29 * TAVNEOS® 29 1 30 — NM Otezla® 495 105 600 594 1% Enbrel® 1,055
Slide 7: Product Sales Grew 6% YoY in Q2 ’23, Driven by 11% Volume Growth
Product Sales Grew 6% YoY in Q2 ’23, Driven by 11% Volume Growth $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • Excluding the impact of foreign exchange, Total Change 6% 14% product sales increased 8% YoY ROW Units 11% 5% U.S. Inventory (1%) 3% • Record quarterly sales of 9 products • Delivered d
Slide 8: Repatha Achieved Record Quarterly Sales
Repatha® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • Global PCSK9 segment leader Total Change 30% 9% ROW Units 35% 11% • YoY sales increased 30%, driven by 35% U.S. Inventory 0% 2% volume growth, partially offset by lower net selling price* • U.S. sales grew 38%
Slide 9: Prolia Achieved Record Quarterly Sales, Exceeding $1 Billion
Prolia® Achieved Record Quarterly Sales, Exceeding $1 Billion $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 11%, driven by 11% Total Change 11% 11% ROW Units 11% 12% volume growth U.S. Inventory (1%) 0% • We expect to treat over 7 million patients with Prolia® in 2023 Note: I
Slide 10: EVENITY Achieved Record Quarterly Sales, Annualizing at Over $1 Billion
EVENITY® Achieved Record Quarterly Sales, Annualizing at Over $1 Billion $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 47%, primarily Total Change 47% 11% ROW Units 53% 16% driven by volume growth U.S. Inventory (5%) (3%) • U.S. volumes grew 47% YoY • Ex-U.S. volumes grew 64%
Slide 11: TEZSPIRE Sales Increased 39% QoQ
TEZSPIRE® Sales Increased 39% QoQ $ Millions, Net Sales Highlights Q2 ’23 QoQ • 37% QoQ volume growth benefited from Total Change 39% Units 37% the introduction of our self- U.S. Inventory 1% administered, pre-filled, single-use pen • Healthcare providers are increasingly recognizing the unique, dif
Slide 12: TAVNEOS Sales Increased 30% QoQ
TAVNEOS® Sales Increased 30% QoQ $ Millions, Net Sales Highlights Q2 ’23 QoQ • QoQ sales increased 30%, driven by Total Change 30% ROW Units 34% volume growth U.S. Inventory 11% • U.S. volumes grew 28% QoQ, driven by an increase in new patients starting 1 treatment Note: Inventory represents wholesa
Slide 13: Otezla Sales Increased 1% YoY (53% QoQ)
Otezla® Sales Increased 1% YoY (53% QoQ) $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 1%, driven by 2% Total Change 1% 53% ROW Units 2% 4% volume growth U.S. Inventory 0% 17% • U.S. new patient demand is being impacted by newly launched competitor free drug programs • Expect
Slide 14: Enbrel Sales Increased 2% YoY (84% QoQ)
Enbrel® Sales Increased 2% YoY (84% QoQ) $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 2%, driven by Total Change 2% 84% ROW Units 0% 5% favorable changes to estimated sales U.S. Inventory (3%) 21% deductions and higher net selling price*, partially offset by lower inventory
Slide 15: AMGEVITA Ex-U.S. Sales Grew 13% YoY
AMGEVITA™ Ex-U.S. Sales Grew 13% YoY $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 29%, driven by Total Change 29% (9%) ROW Units 60% 21% 60% volume growth, partially offset by U.S. Inventory (14%) (31%) lower inventory levels and net selling price* • U.S. sales decreased 63%
Slide 16: BLINCYTO Achieved Record Quarterly Sales
BLINCYTO® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 48%, driven by 36% Total Change 48% 6% ROW Units 36% 3% volume growth and higher net selling U.S. Inventory 3% 1% price* • Volume growth was supported by strong adoption across academic, c
Slide 17: Vectibix Achieved Record Quarterly Sales
Vectibix® Achieved Record Quarterly Sales $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 20%, driven by 20% Total Change 20% 6% ROW Units 20% 7% volume growth U.S. Inventory 0% 2% • Volume growth was supported by the promotion of positive data from the Phase 3 PARADIGM trial d
Slide 18: KYPROLIS Sales Increased 9% YoY
KYPROLIS® Sales Increased 9% YoY $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 9%, driven by 15% Total Change 9% (3%) ROW Units 15% 1% volume growth, partially offset by lower U.S. Inventory (2%) 0% net selling price* • Volume growth was supported by increased new patient sha
Slide 19: LUMAKRAS/LUMYKRAS Delivered $77M of Sales in Q2
LUMAKRAS®/LUMYKRAS™ Delivered $77M of Sales in Q2 $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales flat as 20% volume growth Total Change 0% 4% ROW Units 20% 5% was offset by lower net selling price* U.S. Inventory (7%) (7%) and inventory levels • Growth opportunities supported by: • Glob
Slide 20: XGEVA Sales Decreased 1% YoY
XGEVA® Sales Decreased 1% YoY $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales decreased 1%, primarily Total Change (1%) (1%) ROW Units (1%) 0% driven by unfavorable changes to U.S. Inventory (1%) 1% estimated sales deductions, lower inventory levels and unfavorable foreign exchange impac
Slide 21: Nplate Sales Increased 9% YoY
Nplate® Sales Increased 9% YoY $ Millions, Net Sales Highlights Q2 ’23 YoY QoQ • YoY sales increased 9%, driven by 15% Total Change 9% (14%) ROW Units 15% (14%) volume growth, partially offset by U.S. government order U.S. Inventory 0% 1% unfavorable foreign exchange impact Note: Inventory represent
Slide 22: Established Products Generated $749M of Q2 Sales And Continued to Deliver Strong Cash Flows
Established Products Generated $749M of Q2 Sales And Continued to Deliver Strong Cash Flows $ Millions, Net Sales Highlights Q2 '23 YoY QoQ • Includes EPOGEN®, Aranesp®, Parsabiv® Total Change (17%) (1%) ROW Units (7%) 1% and Neulasta® U.S. Inventory (1%) 2% • YoY sales decreased 17%, driven by lowe
Slide 23: R&D Update
R&D Update
Slide 24: Oncology/Hematology
Oncology/Hematology Tarlatamab (AMG 757) – first-in-class HLE BiTE® molecule targeting DLL3 • Positive top-line results from Phase 2 DeLLphi-301 study in relapsed or refractory SCLC: – Durable ORR (primary endpoint) that substantially exceeds what was reported in Phase 1. – Safety and tolerability m
Slide 25: 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 26: Oncology/Hematology (continued)
Oncology/Hematology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • Positive Phase 3 results from CodeBreaK 300 evaluating LUMAKRAS® plus Vectibix® in chemorefractory metastatic KRAS G12C mutated CRC. – Met the primary endpoint of PFS for both the 240 mg and 960 mg
Slide 27: Oncology/Hematology (continued)
Oncology/Hematology (continued) LUMAKRAS®/LUMYKRAS™ (sotorasib) – small molecule targeting KRAS G12C • Comprehensive global clinical development program in NSCLC, CRC, and other solid tumors to further explore the potential of LUMAKRAS®. – Investigating multiple novel combinations. – Planning to ini
Slide 28: Oncology/Hematology (continued)
Oncology/Hematology (continued) BLINCYTO® – (blinatumomab) – BiTE® molecule targeting CD19 • FDA accelerated approval converted to full approval in adult and pediatric patients with CD19-positive B-ALL in first or second complete remission with MRD ≥ 0.1%. • Global regulatory submissions planned for
Slide 29: Oncology/Hematology (continued)
Oncology/Hematology (continued) Bemarituzumab – monoclonal antibody targeting FGFR2b • Multiple 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 combina
Slide 30: Oncology/Hematology (continued)
Oncology/Hematology (continued) Xaluritamig (AMG 509) – first-in-class bispecific molecule targeting STEAP1 • Phase 1 dose-escalation/expansion study in mCRPC continues to enroll patients. • Initial data demonstrating responses will be presented at an upcoming medical congress. AMG 340 – lower T-cel
Slide 31: Oncology/Hematology (continued)
Oncology/Hematology (continued) AMG 193 – first-in-class small molecule MTA-cooperative PRMT5 inhibitor • A Phase 1/1b/2 study continues to enroll patients with advanced MTAP-null solid tumors. • Initial data demonstrating responses in multiple tumor types will be presented at an upcoming medical co
Slide 32: General Medicine
General Medicine Maridebart cafraglutide (formerly 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 patients. AMG 786 – small molecule obesity program (target not disclosed)
Slide 33: 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 on the effects of olpasiran on oxidized phospholipids and the long- term efficacy
Slide 34: General Medicine (continued)
General Medicine (continued) Prolia® (denosumab) – monoclonal antibody targeting RANK ligand • In May, the Company presented data from a real-world study of nearly half a million postmenopausal women with osteoporosis in the U.S. Medicare program: – Prolia® substantially reduced fracture risk in pat
Slide 35: Inflammation
Inflammation Otezla® (apremilast) – small molecule PDE4 inhibitor • sNDA based upon Phase 3 DISCREET study data approved by the FDA. • Prescribing information further updated to indicate that the safety profile observed in the Otezla® group during the placebo-controlled phase of the DISCREET study w
Slide 36: Inflammation (continued)
Inflammation (continued) 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
Slide 37: Inflammation (continued)
Inflammation (continued) Rocatinlimab (AMG 451 / KHK4083) – first-in-class monoclonal antibody targeting OX40 • The ROCKET Phase 3 program, composed of seven studies in moderate to severe atopic dermatitis, continues to enroll adult and adolescent patients. • Plan to initiate a Phase 2 study in mode
Slide 38: 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 pati
Slide 39: Biosimilars
Biosimilars ABP 206 an investigational biosimilar to OPDIVO ® (nivolumab) • Enrolling patients in the Phase 1 portion of a randomized, double-blind pivotal study evaluating PK similarity of ABP 206 compared with OPDIVO® (nivolumab). ABP 654, an investigational biosimilar to STELARA ® (ustekinumab) •
Slide 40: Q2 ’23 Business Results and Outlook
Q2 ’23 Business Results and Outlook
Slide 41: Q2 '23 Financial Results
Q2 '23 Financial Results $ Millions, Except Non-GAAP EPS Item Q2 ’23 Q2 ’22 B/(W) % Revenue $6,986 $6,594 6% Product Sales 6,683 6,281 6% Other Revenues 303 313 (3%) Non-GAAP Operating Expenses 3,471 3,259 (7%) Cost of Sales % of product sales 1,142 17.1% 926 14.7% (23%) R&D % of product sales 1,092
Slide 42: Strong Balance Sheet With Free Cash Flows of $3.8B in Q2 '23
Strong Balance Sheet With Free Cash Flows of $3.8B in Q2 '23 $ Billions, Except Dividends Paid Per Share Cash Flow Data Q2 ’23 Q2 ’22 Capital Expenditures $0.3 $0.2 Free Cash Flow* 3.8 1.7 Share Repurchases 0.0 0.0 YoY Dividend Increase 10% 10% Dividends Paid Per Share $2.13 $1.94 Balance Sheet Data
Slide 43: 2023 Guidance (Excludes Any Contribution From Announced Acquisition of Horizon Therapeutics plc)
2023 Guidance (Excludes Any Contribution From Announced Acquisition of Horizon Therapeutics plc) Guidance Comments Revised from Revenue $26.6B–$27.4B $26.2B–$27.3B Revised from Non-GAAP EPS* $17.80–$18.80 $17.60–$18.70 Revised from Non-GAAP Tax Rate* 17.5%–18.5% 18.0%–19.0% Capital Expenditures ~ $9
Slide 44: Q2 ’23 Earnings Call
Q2 ’23 Earnings Call August 3, 2023
Slide 45: Reconciliations
Reconciliations
Slide 46: Consolidated Statements of Income - GAAP
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per - share data) (Unaudited) Three months ended Six months ended June 30, June 30, 2023 2022 2023 2022 Revenues: Product sales $ 6,683 $ 6,281 $ 12,529 $ 12,012 Other revenues 303 313 562 820 Total revenues 6,986 6,594 13,091
Slide 47: Consolidated Balance Sheets - GAAP
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) June 30, December 31, 2023 2022 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $ 34,248 $ 9,305 Trade receivables, net 5,830 5,563 Inventories 4,978 4,930 Other current assets 2,324 2,388 Total current a
Slide 48: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars In millions) (Unaudited) Provided August 3, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 48 materially; Amgen disclaims any duty to update.
Slide 49: 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 June 30, 2023 June 30, 2022 GAAP Non-GAAP
Slide 50: Reconciliations of Cash Flows
Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended Six months ended June 30, June 30, 2023 2022 2023 2022 Net cash provided by operating activities $ 4,109 $ 1,930 $ 5,173 $ 4,094 Net cash provided by (used in) investing activities (211) (2,193) 1,147 (2,304) Net c
Slide 51: Reconciliation of Total Revenues and Product Sales Adjusted for Foreign Exchange
Amgen Inc. Reconciliation of Total Revenues and Product Sales Adjusted for Foreign Exchange (FX) Impact (Dollars in millions) (Unaudited) Three months ended June 30, Three months ended June FX impact % Change 2023 2022 Change FX impact $ (a) (a) 30, 2023 excluding FX excluding FX Product Sales $ 6,6
Slide 52: 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 $ 14.30 — $ 15.41 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 4.55 — 4.60 Net charges related to restructuring and cost s
Slide 53: Q2 ’23 Earnings Call
Q2 ’23 Earnings Call August 3, 2023