56 slides from H. Lundbeck A/s Class A's earnings presentation, Nov 9, 2022
Slide 1: 9M Financial results and business update
9M Financial results and business update November 9, 2022
Slide 2: Company disclaimer
Company disclaimer This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Forward looking statements include, without limitation, any statement that may predict,
Slide 3: 9M performance overview and highlights
9M 2022: Highlights 9M performance overview and highlights (reported numbers) Continued strong DKK 13.6 billion +30% +105% revenue Revenue up 11% Strategic Vyepti sales performance brands revenue (DKK 672 million) Robust profit 24.9% growth with slight DKK 2.4 billion 18.1% EBIT +22% EBIT margin Cor
Slide 4: Strategic brands powering growth across the portfolio
9M 2022: Highlights Strategic brands powering growth across the portfolio % Revenue contribution Strong growth from strategic brands 16,000 Mature brands incl. Other revenue and hedging Strategic brands 12,000 DKKm 35% 8,000 +19% 44% 9M 2021 9M 2022 in L.C. 56% 4,000 65% 0 9M 2021 9M 2022 Other reve
Slide 5: Strategic brands continue strong double-digit growth
9M 2022: Highlights Strategic brands continue strong double-digit growth 23% 35% 9M 2022 revenue by DKK 3.2bn DKK 2.8bn DKK 2.2bn DKK 672m brand % Sales by product (% in local currencies) +15% +19% +13% +82% category % Reported +24% +33% +20% +105% 21% 5% 16% Brintellix/Trintellix Abilify Maintena M
Slide 6: Vyepti: Strong growth, global rollout progressing as planned
9M 2022: Business Update Vyepti: Strong growth, global rollout progressing as planned Strong adoption across new markets U.S. Vyepti demand* • 13% market share in U.A.E. and 4% (weekly - vials) DKK 672m in Switzerland** +82% • Launched in several markets in 2022, in L.C. namely Australia, Canada, Es
Slide 7: Strong Brintellix/Trintellix growth underpinned by excellent efficacy profile
9M 2022: Business Update Strong Brintellix/Trintellix growth underpinned by excellent efficacy profile Continued strong growth in Japan • 9.1% value market share (up 3.3ppt in 2022) +15% DKK 3.177m • Benefitting from stronger in L.C. DKK 2.565m positioning due to increased adoption by psychiatrists
Slide 8: Rexulti sales up +33% in 9M driven by strong demand growth
9M 2022: Business Update Rexulti sales up +33% in 9M driven by strong demand growth Continued strong growth momentum in the U.S... DKK 2.817m • Share at all time high +19% in L.C. • Number of Rx increased with strong DKK 2.112m in person promotion and DTC offering • AAD* launch preparations underway
Slide 9: Abilify Maintena buoyed by solid growth in North America and Europe
9M 2022: Business Update Abilify Maintena buoyed by solid growth in North America and Europe Solid growth in 9M 2022 • Growth mainly driven by the U.S., Spain and Canada +13% DKK 2.164m Strong market share gains in Europe in L.C. DKK 1.810m • Exceeding 30% market share in countries such as Italy, Sw
Slide 10: Financial performance benefitting from growth strategy
9M 2022: Financial Results Financial performance benefitting from growth strategy Key figures Revenue bridge +11% DKKm 9M 2021 9M 2022 Δ -3% 13,565 Revenue 12,246 13,566 +11% +8% 12,246 +6% SG&A 4,766 5,496 +15% R&D 2,828 2,849 +1% 9M 2021 Organic FX Hedging 9M 2022 EBIT 2,004 2,449 +22% (in % of re
Slide 11: Financial results in 9M 2022
9M 2022: Financial Results Financial results in 9M 2022 Strong growth of 22% in EBIT Reported numbers Comments DKKm 9M 2021 9M 2022 Δ • Underlying organic EBIT growth of +22% EBIT 2,004 2,449 +22% • Increase in net financial expenses Net financials, expenses 311 392 +26% predominantly due to Q1 2022
Slide 12: Solid operational cash flow despite launch and growth investments in Vyepti
9M 2022: Financial Results Solid operational cash flow despite launch and growth investments in Vyepti DKKm 9M 2021 9M 2022 Comments EBIT 2,004 2,449 • EBIT growth of 22% drives stronger operational cash flow Adjustments for non-cash items 636 1,110 • Changes in net working capital driven Change in
Slide 13: FY 2022 financial guidance
9M 2022: Financial Results FY 2022 financial guidance DKKm Revenue EBITDA Core EBIT EBIT Updated 2022 17.9 ̶ 18.2bn 4.4 ̶ 4.6bn 3.9 ̶ 4.1bn 2.6 ̶ 2.8bn Reaffirming Guidance (DKKm) Previous 2022 17.2 ̶ 17.7bn 4.2 ̶ 4.5bn 3.8 ̶ 4.1bn 2.4 ̶ 2.7bn 2022 Guidance (DKKm) Revenue Other housekeeping items gu
Slide 14: Continue to build our brands through effective LCM
9M 2022: R&D Update Continue to build our brands through effective LCM Aripiprazole – Brexpiprazole 2-Month Injectable (LAI) Vyepti formulation • AAD – Progression according to • Submitted in the U.S., EU, and • SUNRISE trial: plan towards sNDA submission Canada • Asia pivotal study enrolling well e
Slide 15: Brintellix/Trintellix MEMORY trial: Reduced depressive symptoms and improved cognition
9M 2022: R&D Update Brintellix/Trintellix MEMORY trial: Reduced depressive symptoms and improved cognitive performance in MDD patients with dementia MEMORY trial (n=83) Cognitive performance Health-related quality of life • In patients with MDD and early 0.8 DSST 14 Total score dementia vortioxetine
Slide 16: Strong progression in the early and mid-stage pipeline
9M 2022: R&D Update Strong progression in the early and mid-stage pipeline Phase II Phase I (selected) • Lu AF82422 (anti-alpha-synuclein • Lu AF28996 (D1/D2 agonist) mAb): AMULET PoC trial (MSA) in progressing well towards completion Japan and the U.S. finished of phase IB enrolment ahead of time •
Slide 17: Lu AG09222 holds the potential to be first-in-class in migraine prevention
9M 2022: R&D Update Lu AG09222 holds the potential to be first-in-class with a differentiated approach to migraine prevention • A differentiated approach to migraine prevention • Selective PACAP1) binding humanized (ligand-binding) IgG1 antibody • Pre-clinical data2) indicate that PACAP and CGRP3) m
Slide 18: Focused on driving long term sustainable growth
9M 2022: Outlook | Long term growth Focused on driving long term sustainable growth Maximize Continue R&D Secure mid- Strategic transformation for and late decade Brands mid- and long-term growth through BD innovation Restoring Brain Health so Actively Every Person • Accelerate and • Focus in 4 biol
Slide 19: Q&A
Q&A RESULTS DECK 19
Slide 20: Appendix
Appendix RESULTS DECK 20
Slide 21: Product distribution of revenue – 9M 2022 and FY 2021
9M 2022: APPENDIX Product distribution of revenue – 9M 2022 and FY 2021 DKKm FY 2021 FY 2020 9M 2022 9M 2021 Growth Growth in local % of total currencies (9M 2022) TOTAL: Brintellix/Trintellix 3,526 3,102 3,177 2,565 24% 15% 23% Rexulti/Rxulti 2,849 2,620 2,817 2,112 33% 19% 21% Abilify Maintena 2,4
Slide 22: Product distribution of revenue – Q3 2022 and FY 2021
9M 2022: APPENDIX Product distribution of revenue – Q3 2022 and FY 2021 DKKm FY 2021 FY 2020 Q3 2022 Q3 2021 Growth Growth in local % of total currencies (Q3 2022) TOTAL: Brintellix/Trintellix 3,526 3,102 1,126 909 24% 13% 24% Rexulti/Rxulti 2,849 2,620 1,046 734 43% 23% 22% Abilify Maintena 2,420 2
Slide 23: Seeing double digit growth in all regions
9M 2022: APPENDIX Seeing double digit growth in all regions +11% Strategic in L.C. brands continues to Europe show robust demand 23% growth across most markets Vyepti 48% is an increasing contributor to growth as +6% global roll out ramps up in L.C. 29% United States +5% in L.C. International market
Slide 24: Total molecule sales (gross) - USDm
9M 2022: APPENDIX Total molecule sales (gross) - USDm 1.250 1.600 +32% 1.000 +49% 1.200 750 800 500 250 400 0 0 2014 2015 2016 2017 2018 2019 2020 2021 2014 2015 2016 2017 2018 2019 2020 2021 Abilify Maintena: U.S. approval (Feb. 2013); EU approval (Nov. 1.600 2013) Brintellix/Trintellix: U.S. appro
Slide 25: Volume growth in the U.S. impacted by the pandemic (NRx Count)
9M 2022: APPENDIX Volume growth in the U.S. impacted by the pandemic (NRx Count) +8% 50,000 +8% 400,000 +6% 0% +1% -1% 25,000 200,000 0 0 Q3.18 Q3.19 Q3.20 Q3.21 Q3.22 Q3.18 Q3.19 Q3.20 Q3.21 Q3.22 200,000 +14% 400 +10% +8% +107% +6% 100,000 200 0 0 Q3.18 Q3.19 Q3.20 Q3.21 Q3.22 Q3.20 Q3.21 Q3.22 So
Slide 26: Volume growth in the U.S. impacted by the pandemic (TRx Count)
9M 2022: APPENDIX Volume growth in the U.S. impacted by the pandemic (TRx Count) +9% 125,000 +8% 800,000 +7% +1% -2% 0% 100,000 600,000 75,000 400,000 50,000 200,000 25,000 0 0 Q3.18 Q3.19 Q3.20 Q3.21 Q3.22 Q3.18 Q3.19 Q3.20 Q3.21 Q3.22 +13% +34% 300,000 +7% +7% 600 +127% 200,000 400 100,000 200 0 0
Slide 27: Strong strategic brands growth globally
9M 2022: APPENDIX Strong strategic brands growth globally United States International markets Europe Solid underlying growth +6% +5% +11% in Europe and in LC in LC in LC International markets driven by demand 9M 2021 9M 2022 9M 2021 9M 2022 9M 2021 9M 2022 Strategic brands Strategic brands Strategic
Slide 28: Strategic brands are major revenue contributors, continuing strong growth momentum
9M 2022: APPENDIX Strategic brands are major revenue contributors, continuing strong growth momentum Strategic brands* revenue +30% Strategic brands sales growth (+19% in L.C.) (Quarterly - DKKm) 4,000 Europe International Markets United States DKK 8.8bn Global Lundbeck sales in 9M 2022 (65% of tota
Slide 29: Vyepti: Robust uptake continues
9M 2022: APPENDIX Vyepti: Robust uptake continues Grew 105% (82% in L.C.) to DKK 672m in 9M 2022 Vyepti sales Vyepti sales (Quarterly - DKKm) (9M – DKKm) Launched in the U.S., 300 +87% 750 Australia, Canada, Estonia, Finland, +105% Germany, Kuwait, Singapore, Sweden, Switzerland and U.A.E. 200 500 A
Slide 30: Brintellix/Trintellix: Solid underlying performance driven by strong clinical profile
9M 2022: APPENDIX Brintellix/Trintellix: Solid underlying performance driven by strong clinical profile Brintellix/Trintellix sales per region Brintellix/Trintellix (Quarterly - DKKm) (9M – DKKm) Grew 15% (L.C.) to DKK 3.2bn in 9M 2022 1,500 4,500 Europe United States Europe United States Internatio
Slide 31: Rexulti: Growing 33% – an effective drug that is meeting patient needs
9M 2022: APPENDIX Rexulti: Growing 33% – an effective drug that is meeting patient needs Rexulti sales per region** Rexulti sales** Grew 19% in L.C. to DKK 2.8bn (Quarterly - DKKm) (9M - DKKm) in 9M 2022 1,500 4,500 Other regions Other regions Continued solid traction United States United States in
Slide 32: Abilify Maintena: Growing 20% in 9M 2022
9M 2022: APPENDIX Abilify Maintena: Growing 20% in 9M 2022 Grew 13% (L.C.) to DKK 2.2bn in 9M 2022 Abilify Maintena sales per region** Abilify Maintena (Quarterly - DKKm) (9M – DKKm) Global LAI market up 4% 1,050 Europe United States 3,000 Europe United States to USD 4.6bn (9M 2022)* International M
Slide 33: Cipralex/Lexapro: Sales grew 2% in 9M 2022
9M 2022: APPENDIX Cipralex/Lexapro: Sales grew 2% in 9M 2022 Cipralex/Lexapro Cipralex/Lexapro Grew 2% (unchanged in L.C.) (Quarterly - DKKm) (9M– DKKm) to DKK 1.9bn in 9M 2022 900 2,500 Europe International Markets Europe International Markets +3% +2% The biggest markets are 2,000 Japan, China, Sou
Slide 34: Sabril: Sales impacted by generic erosion from Q3 2017
9M 2022: APPENDIX Sabril: Sales impacted by generic erosion from Q3 2017 Sabril sales Sabril sales (Quarterly - DKKm) (9M– DKKm) 250 600 200 Grew 6% (down 9% in L.C.) to -1% DKK 160m in Q3 2022 +6% 150 400 Declined 1% (12% in L.C.) 100 to DKK 482m in 9M 2022 50 0 200 Q3.20 Q3.21 Q3.22 9M 2020 9M 202
Slide 35: Onfi: Sales impacted by generic erosion from October 2018
9M 2022: APPENDIX Onfi: Sales impacted by generic erosion from October 2018 Onfi sales Onfi sales (Quarterly - DKKm) (9M – DKKm) 200 700 Increased 11% (down 4% in L.C.) to DKK 108m in Q3 2022 +11% -17% 100 350 Declined 17% (26% in L.C.) to DKK 317m in 9M 2022 0 0 Q3.20 Q3.21 Q3.22 9M 2020 9M 2021 9M
Slide 36: Other pharmaceuticals
9M 2022: APPENDIX Other pharmaceuticals Grew 4% (down 3% in L.C.) to DKK 756m in Q3 2022 Other pharmaceuticals Other pharmaceuticals (Quarterly - DKKm) (9M – DKKm) Declined 7% (13% in L.C.) to DKK 2.3bn in 9M 2022 1,500 4,500 Around 15 mature products included 3,600 Biggest products are Azilect, Cip
Slide 37: Other revenue
9M 2022: APPENDIX Other revenue Other revenue Other revenue (Quarterly - DKKm) (9M – DKKm) Declined 16% (down 16% in L.C.) 500 150 to DKK 49m in Q3 2022 -16% Declined 3% (down 4% in L.C.) to DKK 205m in 9M 2022 250 -3% Mostly contract manufacturing to third-party 0 0 Q3.20 Q3.21 Q3.22 9M 2020 9M 202
Slide 38: Core operating profit maintained at robust level
9M 2022: APPENDIX Core operating profit maintained at robust level Q3 2022 core EBIT reconciliation (DKKm) 1.299 0 0 Q3 2022 952 347 • Core EBIT reached DKK 1,299 million in Q3 2022 • Amortizations increased from DKK 300 million in Q3 2021 to DKK 347 million due to the appreciating USD Reported EBIT
Slide 39: Solid financial foundation from which to execute on our strategy
9M 2022: APPENDIX Solid financial foundation from which to execute on our strategy Net debt and Net debt/EBITDA* (FY - DKKm) FY 2022: Cash flow negatively impacted by: 8.000 1,2 • Significant milestone payment for EMA approval of Vyepti 6.635 • Dividend 6.000 0,8 • CAPEX investments 4.000 3,677 • In
Slide 40: Cash position, funding and debt maturity
9M 2022: APPENDIX Cash position, funding and debt maturity Debt maturity profile (EURm equivalent) A diversified and long-term balanced debt portfolio is a priority to Lundbeck 1.500 This includes access to various funding sources as well as a balanced maturity profile to support the Expand and Inve
Slide 41: 9M 2022 impacted by appreciation of main currencies
9M 2022: APPENDIX 9M 2022 impacted by appreciation of main currencies 9M 2022 sales by currency Main currencies** (January 1, 2021 = index 100) EUR Other* 17% 130 22% 125 Spot Lundbeck’s Avg. Avg. Avg. Avg. Oct. hedging 9M 9M Q2 Q3 120 24, rate 2021 2022 2022 2022 2022 115 CAD 5% 110 USD 752.14 645
Slide 42: Cash generation
9M 2022: APPENDIX Cash generation DKKm 9M 2022 9M 2021 FY 2021 FY 2020 FY 2019 Cash flows from operating activities 2,232 1,889 2,272 3,837 2,609 Cash flows from investing activities (1,360) (332) (610) (467) (7,755) Cash flows from operating and investing 872 1,557 1,662 3,370 (5,146) activities (f
Slide 43: Financial position and dividend
9M 2022: APPENDIX Financial position and dividend Dividend (DKK) DKKm 30.09.2022 31.12.2021 15 5% Intangible assets 23,765 22,750 Dividend Other non-current assets 3,506 3,291 12 4% Yield (r.h.s.) Current assets 12,034 8,612 9 3% Assets 39,305 34,653 6 2% Equity 20,919 18,279 3 1% Non-current liabil
Slide 44: Costs – Full year figures
9M 2022: APPENDIX Costs – Full year figures DKKm 2021 2020 2019 2021 (∆%) 2020 (∆%) Revenue 16,299 17,672 17,036 (8%) 4% Cost of sales 3,648 4,166 3,840 (12%) 8% Sales & Distribution costs 5,885 5,946 5,514 (1%) 8% Administrative expenses 933 966 899 (3%) 7% R&D costs 3,823 4,545 3,116 (16%) 46% Tot
Slide 45: Migraine prevention represents a large and underserved market
9M 2022: APPENDIX Migraine prevention represents a large and underserved market Migraine is divided into two major categories, episodic and Addressable population chronic depending on the frequency of headaches (major countries) 1-14 headache days >14 headache days per month per month ~135m – Migrai
Slide 46: Vyepti: Moving into new frontiers; adapting based on learnings
9M 2022: APPENDIX Vyepti: Moving into new frontiers; adapting based on learnings US & Europe Asia program Well-established effect China: New insights Japan: Unknown effect PROMISE I/II SUNLIGHT SUNRISE SUNSET RELIEF • China, Europe, Korea • Japan, China, Europe, Korea • MOH in chronic migraine • Chr
Slide 47: Eptinezumab: Phase III study for treatment of cluster headache
9M 2022: APPENDIX Eptinezumab: Phase III study for treatment of cluster headache, a crippling pain with few effective medications currently available Cluster headache affects approximately one in 1,000 people across the world ALLEVIATE phase III study to evaluate eptinezumab in episodic Cluster Head
Slide 48: Aripiprazole 2M RTU submitted in the U.S., Canada and EU
9M 2022: APPENDIX Aripiprazole 2M RTU submitted in the U.S., Canada and EU: Potential to further maximize the franchise A long-acting injectable formulation ensures continuous exposure to medication and through a simplified treatment regimen, many of the challenges with poor treatment adherence may
Slide 49: Two studies in brexpiprazole pivotal program in PTSD ongoing
9M 2022: APPENDIX Two studies in brexpiprazole pivotal program in PTSD ongoing Two studies initiated in the pivotal programme (phase III) Brexpiprazole (fixed 2, 3mg and flexible dose up to 3mg) in combination with sertraline Study objective1 • Primary endpoint: Clinician-Administered PTSD Scale for
Slide 50: Lu AF82422 (anti alpha-synuclein mAb) in phase II for Multiple System Atrophy
9M 2022: APPENDIX Lu AF82422 (anti alpha-synuclein mAb) in phase II for the devastating disease Multiple System Atrophy (MSA) MSA – a rare, aggressive, disease with a high Mechanism of Action unmet medical need1 Synucleinopathy; classified as an “atypical parkinsonism” disorder Average time from fir
Slide 51: Lu AF82422: Innovative development program
9M 2022: APPENDIX Lu AF82422: Innovative development program Phase II study (AMULET)1): PoC study investigating the effect of Lu AF82422 on disease progression in patients with early multiple system atrophy (MSA) • Biomarker-supported study • Commenced November 2021 Primary endpoint: Change from bas
Slide 52: Broad MAGLipase program ongoing
9M 2022: APPENDIX Broad MAGLipase program ongoing Lu AG06474 Peripherally restricted Lu AG06466 Phase I study initiated in August 20214) Inhibitor of the monoacylglycerol lipase (MAGL) and selective modulator of the endocannabinoid system CNS penetrant Ongoing phase Ib studies • Spasticity in partic
Slide 53: Lu AF28996: A potentially new oral treatment for Parkinson's patients
9M 2022: APPENDIX Lu AF28996: A potentially new oral treatment for Parkinson’s patients experiencing motor fluctuations D1/D2-type agonists Lu AF28996 Phase I studies: • Single- and sequential- Known to be highly efficacious A highly potent agonist at the D1- ascending-dose of Lu AF28996 to even in
Slide 54: Focus on promising biology
9M 2022: APPENDIX Focus on promising biology Selected four biology clusters feeding into our strategy Scientifically well-described areas still rich in targets with untapped potential High feasibility for early de-risking and maintaining a competitive edge Circuitry / neuronal biology Well-establish
Slide 55: Broad pipeline to sustain future growth
9M 2022: R&D Update Broad pipeline to sustain future growth Biology Project Area Phase I Phase II Phase III Filing/launch 1) Eptinezumab (anti-CGRP mAb) Migraine prevention SUN-studies PROMISE 1 & 2 1) Eptinezumab (anti-CGRP mAb) Episodic cluster headache ALLEVIATE Hormonal / neuropeptide signaling
Slide 56: For more information, please contact Investor Relations
9M 2022: APPENDIX For more information, please contact Investor Relations IR contact Number of A-shares 199,148,222 Number of B-shares 796,592,888 Palle Holm Olesen Listed on the Copenhagen Stock Total 995,741,110 VP; Head of Investor Relations Exchange since June 18, 1999 Treasury shares1 502,115 (