Amgen Inc. · NASDAQ:AMGN
Amgen — Q2 2022 Earnings Presentation
49 slides from Amgen's earnings presentation, Aug 4, 2022
Slide 1: Q2 '22 Earnings Call
Q2 ’22 EARNINGS CALL August 4, 2022
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 Q2 ’22 Business Results and Outlook Peter Griffith Global Commercial Update Murdo Gordon Research & Development Update David Reese Q&A All Provided August 4, 2022, as part of an oral presentation and is qualified by such, contains forward-l
Slide 4: We Continued to Execute Effectively in Q2 2022
WE CONTINUED TO EXECUTE EFFECTIVELY IN Q2 2022 • Ongoing strong execution of our volume-driven growth strategy • Robust launches continue, with growing global LUMAKRAS® presence and accelerating TEZSPIRE® uptake • Tight operating expense control while investing in growth opportunities • Robust pipel
Slide 5: Q2 '22 Business Results and Outlook
Q2 ’22 BUSINESS RESULTS AND OUTLOOK
Slide 6: Q2 2022 Financial Results
Q2 2022 FINANCIAL RESULTS $ Millions, Except Non-GAAP EPS Item Q2 ’22 Q2 ’21 B/(W) % Revenue $6,594 $6,526 1% Product Sales 6,281 6,114 3% Other Revenues 313 412 (24%) Non-GAAP Operating Expenses 3,259 4,920 34% Cost of Sales % of product sales 926 14.7% 1,034 16.9% 10% R&D % of product sales 1,020
Slide 7: Strong Balance Sheet with Free Cash Flow of $1.7B in Q2 2022
STRONG BALANCE SHEET WITH FREE CASH FLOW OF $1.7B IN Q2 2022 $ Billions, Except Dividends Paid Per Share Cash Flow Data Q2 ’22 Q2 ’21 Capital Expenditures $0.2 $0.2 Free Cash Flow* 1.7 1.7 Share Repurchases — 1.6 YoY Dividend Increase 10% 10% Dividends Paid Per Share $1.94 $1.76 Balance Sheet Data 6
Slide 8: 2022 Guidance
2022 GUIDANCE Guidance Comments Revised from Revenue $25.5B–$26.4B $25.4B–$26.5B Non-GAAP EPS* $17.00–$18.00 Unchanged Revised from Non-GAAP Tax Rate* 14.0%–15.0% 13.5%–14.5% Capital Expenditures ~$950M Unchanged *Non-GAAP financial measure—if this slide is in hard copy, see reconciliations accompan
Slide 9: Global Commercial Update
GLOBAL COMMERCIAL UPDATE
Slide 10: Q2 '22 Global Commercial Update
Q2 ’22 GLOBAL COMMERCIAL UPDATE Q2 ’22 Q2 ’21 YoY $ Millions, Net Sales U.S. ROW Total Total Total Prolia® 611 311 922 814 13% EVENITY® 130 61 191 131 46% Repatha® 154 171 325 286 14% Aimovig® 88 4 92 82 12% TEZSPIRE® 29 — 29 — NM Otezla® 487 107 594 534 11% Enbrel® 1,036 15 1,051 1,144 (8%) AMGEVIT
Slide 11: Q2 '22 Product Sales Increased 3%, with Strong Volume Growth of 10%
Q2 ’22 PRODUCT SALES INCREASED 3%, WITH STRONG VOLUME GROWTH OF 10% $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • Foreign exchange unfavorably Total Change 3% 10% ROW Units 10% 8% impacted product sales by 2% YoY U.S. Inventory 0% 3% • Continued to execute our volume driven growth strateg
Slide 12: Prolia Had Record Quarterly Sales in Q2
PROLIA® HAD RECORD QUARTERLY SALES IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 13%, primarily Total Change 13% 8% ROW Units 12% 8% driven by 12% volume growth U.S. Inventory (1%) 0% Note: Inventory represents wholesaler inventories Provided August 4, 2022, as p
Slide 13: EVENITY Had Record Quarterly Sales in Q2
EVENITY® HAD RECORD QUARTERLY SALES IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change 46% 12% • YoY sales increased 46%, driven by ROW Units 51% 16% volume growth U.S. Inventory 0% 1% • U.S. sales increased 65% YoY, driven by 60% volume growth • Ex-U.S. sales grew 17%, driven
Slide 14: Repatha Volume Grew 55% YoY
REPATHA® VOLUME GREW 55% YOY $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change 14% (1%) • YoY sales increased 14%, driven by 55% ROW Units 55% 10% volume growth, partially offset by lower U.S. Inventory 0% 0% net selling price* • U.S. sales grew 8%, driven by 38% volume growth, par
Slide 15: Aimovig Sales Increased 12% YoY
AIMOVIG® SALES INCREASED 12% YOY $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 12%, primarily Total Change 12% (9%) ROW Units (11%) 0% driven by higher net selling price*, U.S. Inventory (5%) (4%) partially offset by a 11% decline in volume 3 2 4 2 *Net selling price r
Slide 16: Strong Launch of TEZSPIRE Continued in Q2
STRONG LAUNCH OF TEZSPIRE® CONTINUED IN Q2 Q2 ’22 Highlights Q2 ’22 QoQ • Strong adoption by both allergists and Total Change 314% ROW Units 297% pulmonologists U.S. Inventory 16% • Healthcare providers acknowledge the unique, differentiated profile of TEZSPIRE® and its potential to treat 2.5 millio
Slide 17: Otezla Sales Increased 11% YoY
OTEZLA® SALES INCREASED 11% YOY $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 11%, driven by 8% Total Change 11% 32% ROW Units 8% 8% volume growth and favorable changes U.S. Inventory 0% 9% to estimated sales deductions, partially offset by lower net selling price* • I
Slide 18: Enbrel's Established Record of Safety and Efficacy Continued to Serve Patients
ENBREL®’S ESTABLISHED RECORD OF SAFETY AND EFFICACY CONTINUED TO SERVE PATIENTS $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change (8%) 22% • YoY sales decreased 8%, primarily driven ROW Units (3%) 3% by lower net selling price* and 3% volume U.S. Inventory 2% 8% decline 26 • Contin
Slide 19: AMGEVITA Continued to Be Most Prescribed Adalimumab Biosimilar in Europe
AMGEVITA™ CONTINUED TO BE THE MOST PRESCRIBED ADALIMUMAB BIOSIMILAR IN EUROPE $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change 8% 7% • YoY sales increased 8%, driven by 32% ROW (ex U.S.) Units 32% 14% volume growth, partially offset by Inventory 0% 0% foreign exchange impact and l
Slide 20: LUMAKRAS/LUMYKRAS Now Approved in Over 40 Countries
LUMAKRAS®/LUMYKRAS™ NOW APPROVED IN OVER 40 COUNTRIES Q2 ’22 Highlights Q2 ’22 QoQ Total Change 24% • In the U.S., LUMAKRAS® has been ROW Units 22% prescribed to over 3,000 patients by over U.S. Inventory 4% 1,900 physicians in both academic and community settings • Outside the U.S., LUMYKRAS™ is no
Slide 21: KYPROLIS Had Record Quarterly Sales in Q2
KYPROLIS® HAD RECORD QUARTERLY SALES IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 13%, driven by 19% Total Change 13% 10% ROW Units 19% 7% volume growth, partially offset by lower U.S. Inventory 0% 2% net selling price* *Net selling price represents the impact o
Slide 22: XGEVA Sales Grew 9% in Q2
XGEVA® SALES GREW 9% IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 9%, driven by Total Change 9% 6% ROW Units 0% 4% higher net selling price* and favorable U.S. Inventory 0% 3% changes to estimated sales deductions • Volume remained flat YoY in the second quarter
Slide 23: Vectibix Sales Decreased 13% in Q2
VECTIBIX® SALES DECREASED 13% IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change (13%) 3% • In the U.S., sales grew 4% YoY, driven ROW Units (11%) 4% U.S. Inventory 0% 2% by volume growth • YoY sales decreased 13%, driven by timing of shipments to Takeda, our partner in Japan,
Slide 24: Nplate Had Record Quarterly Sales in Q2
NPLATE® HAD RECORD QUARTERLY SALES IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • YoY sales increased 16%, primarily Total Change 16% 7% ROW Units 11% 7% driven by 11% volume growth and U.S. Inventory (2%) 0% higher net selling price* *Net selling price represents the impact of list
Slide 25: BLINCYTO Had Record Quarterly Sales in Q2
BLINCYTO® HAD RECORD QUARTERLY SALES IN Q2 $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change 29% 1% • YoY sales increased 29%, driven by ROW Units 30% 6% volume growth U.S. Inventory (1%) (2%) • Only approved bispecific T-cell engager (BiTE®) immunotherapy Note: Inventory represent
Slide 26: MVASI Continued to Be Market Leader Within U.S. Bevacizumab Segment
MVASI® CONTINUED TO BE THE MARKET LEADER WITHIN THE U.S. BEVACIZUMAB SEGMENT $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change (17%) 0% • YoY sales decreased 17%, driven by lower ROW Units 10% 9% net selling price*, partially offset by 10% U.S. Inventory 1% 2% volume growth • Conti
Slide 27: KANJINTI Continued to Be Market Leader Within U.S. Trastuzumab Segment
KANJINTI® CONTINUED TO BE THE MARKET LEADER WITHIN THE U.S. TRASTUZUMAB SEGMENT $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ Total Change (46%) (11%) • YoY sales decreased 46%, primarily ROW U.S. Units (7%) 7% driven by declines in net selling price* Inventory (1%) 0% and volume • Continue
Slide 28: Established Products Generated $963M of Q2 Sales
ESTABLISHED PRODUCTS GENERATED $963M OF Q2 SALES AND CONTINUED TO DELIVER STRONG CASH FLOWS $ Millions, Net Sales Q2 ’22 Highlights Q2 ’22 YoY QoQ • Includes Neulasta®, NEUPOGEN®, Total Change (15%) (1%) EPOGEN®, Aranesp®, Parsabiv®, and ROW Units (1%) 6% U.S. Inventory 1% 1% Sensipar®/Mimpara™ • Yo
Slide 29: Research & Development Update
RESEARCH & DEVELOPMENT UPDATE
Slide 30: Q2 '22 Earnings Call—R&D Update: Inflammation
Q2 ’22 EARNINGS CALL—R&D UPDATE Inflammation • Otezla® (apremilast) – The primary and secondary endpoints of the SPROUT study, an international Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating Otezla® in pediatric patients (ages 6 through 17) with moderate to seve
Slide 31: R&D Update: Inflammation (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Inflammation (continued) TEZSPIRE® (Tezepelumab-ekko) – monoclonal antibody targeting TSLP (continued) – The PASSAGE Phase 4 real-world effectiveness study and the WAYFINDER Phase 3b study are enrolling patients with severe asthma. – The SUNRISE Phase 3 study, designe
Slide 32: R&D Update: Inflammation (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Inflammation (continued) • Rocatinlimab (AMG 451 / KHK4083) – monoclonal antibody targeting OX40 – The ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate to severe atopic dermatitis was initiated in June. Following additional discussions with reg
Slide 33: R&D Update: Oncology / Hematology
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology / Hematology • LUMAKRAS® / LUMYKRAS™ (sotorasib) – In June, data were presented at ASCO where investigators evaluated patterns of resistance to LUMAKRAS® in patients with NSCLC and CRC at disease progression. These and other data continue to guide the LUMAKRA
Slide 34: R&D Update: Oncology / Hematology (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology / Hematology (continued) • LUMAKRAS® / LUMYKRAS™ (sotorasib) (continued) – Top-line results from the event-driven, confirmatory Phase 3 study comparing LUMAKRAS® to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in Q3-2022. – Top-lin
Slide 35: R&D Update: Oncology / Hematology (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology / Hematology (continued) • Vectibix® – monoclonal antibody targeting EGFR – In June, the Company and its partner Takeda Pharmaceutical Company presented data from the Phase 3 PARADIGM clinical trial of Vectibix® in Japanese patients with previously untreated
Slide 36: R&D Update: Oncology / Hematology (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology / Hematology (continued) • Bemarituzumab – monoclonal antibody targeting FGFR2b (continued) • A Phase 3 study (FORTITUDE-101) of bemarituzumab plus chemotherapy, versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression continue
Slide 37: R&D Update: Oncology / Hematology (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology/Hematology (continued) • Tarlatamab (AMG 757) – HLE BiTE® molecule targeting DLL3 – Updated exploration and first expansion Phase 1 data in heavily pretreated patients with relapsed/refractory SCLC will be presented on Aug 8th at WCLC. – Tarlatamab demonstrat
Slide 38: R&D Update: Oncology / Hematology (continued)
Q2 ’22 EARNINGS CALL—R&D UPDATE Oncology/Hematology (continued) • AMG 509 – bispecific molecule targeting STEAP1 – A Phase 1 dose escalation study continues to enroll patients with mCRPC. • AMG 340 – lower T-cell affinity BiTE® molecule targeting PSMA – A Phase 1 dose-escalation study continues to e
Slide 39: R&D Update: General Medicine
Q2 ’22 EARNINGS CALL—R&D UPDATE General Medicine • Repatha® - monoclonal antibody targeting PCSK9 – An abstract based on data from the Repatha® OLE studies (FOURIER OLE) has been accepted as a late-breaking presentation for the European Society of Cardiology annual conference in August. • Olpasiran
Slide 40: R&D Update: Biosimilars
Q2 ’22 EARNINGS CALL—R&D UPDATE Biosimilars • ABP 654 –investigational biosimilar to STELARA®(ustekinumab) – Final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA® (ustekinumab) in adult patients with moderate to severe plaque psoriasis expected in 202
Slide 41: Q2 '22 Earnings Call
Q2 ’22 EARNINGS CALL August 4, 2022
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) Provided August 4, 2022, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary 43 materially; Amgen disclaims any duty to update.
Slide 44: Consolidated Balance Sheets - GAAP
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) June 30, December 31, 2022 2021 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $ 7,183 $ 8,037 Trade receivables, net 5,327 4,895 Inventories 4,554 4,086 Other current assets 2,258 2,367 Total current as
Slide 45: GAAP to Non-GAAP Reconciliations
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars In millions) (Unaudited) Provided August 4, 2022, 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 June 30, 2022 June 30, 2021 GAAP Non-GAAP
Slide 47: Reconciliations of Cash Flows
Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended Six months ended June 30, June 30, 2022 2021 2022 2021 Net cash provided by operating activities $ 1,930 $ 1,931 $ 4,094 $ 4,035 Net cash (used in) provided by investing activities (2,193) 1,209 (2,304) 890 Net cas
Slide 48: 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, 2022 (Unaudited) GAAP diluted EPS guidance $ 11.01 — $ 12.15 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 4.02 — 4.11 Loss on divestiture (b) 1.02 — 1.07 Net losses
Slide 49: Q2 '22 Earnings Call
Q2 ’22 EARNINGS CALL August 4, 2022