62 slides from H. Lundbeck A/s Class A's earnings presentation, Feb 8, 2023
Slide 1: Financial results and business update 2022
8 FEBRUARY 2023 Financial results and business Jenna Humphries, Australia Living with migraine update 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: 2022 performance overview and highlights
FY 2022: Business update 2022 performance overview and highlights (reported numbers) Excellent Strategic brands Robust profit growth, Pipeline revenue deliver strong double- while investing for continues to performance digit growth growth progress DKK 18.2 bn DKK 4.66 bn Brexpiprazole AAD Revenue up
Slide 4: Strategic brands powering growth across the portfolio
FY 2022: Business update Strategic brands powering growth across the portfolio % Revenue contribution Strong growth from strategic brands 20,000 +12% in L.C. 16,000 +7% in L.C. 23% 24% 12,000 DKKm +20% 47% in L.C. 2021 49% 2022 8,000 67% 29% 4,000 58% 28% +6% in L.C. 0 2021 2022 USA International Ma
Slide 5: Vyepti: Strong growth in the U.S.
FY 2022: Business update Vyepti: Strong growth in the U.S. U.S. Vyepti demand* Revenue U.S. growth advances (weekly - vials) (DKKm) • Strong growth based on improved DKK 1.004m sales force effectiveness and KOL engagement +80% in L.C. • Growth in new patients starts with continued persistency outpac
Slide 6: Vyepti: Global rollout progressing as planned
FY 2022: Business update Vyepti: Global rollout progressing as planned Strong adoption across new markets • Launched in nine markets in 2022: Australia, Canada, Denmark, Estonia, Finland, Germany, Singapore, Sweden and Switzerland • Volume share of prevention market: • 13% market share in U.A.E. • 6
Slide 7: Strong Brintellix/Trintellix growth underpinned by excellent efficacy profile
FY 2022: Business update Strong Brintellix/Trintellix growth underpinned by excellent efficacy profile Excellent development of sales in Japan • 10.1% value market share (up 4.3ppt in 2022) • In Japan, Trintellix continues to grow with +13% in DKK 4,277m stronger positioning as a first-line treatmen
Slide 8: Rexulti sales growth outstanding in 2022 driven by strong demand growth
FY 2022: Business update Rexulti sales growth outstanding in 2022 driven by strong demand growth Continued strong growth momentum in U.S. Rexulti demand* Revenue the U.S... (Monthly - TRx) (DKKm) • Share at all time high 110,000 DKK 3,890m • Number of Rx increased with strong +21% in L.C. in person
Slide 9: Abilify Maintena delivered solid growth in North America and Europe
FY 2022: Business update Abilify Maintena delivered solid growth in North America and Europe Strong growth in 2022 Global LAI sales and Abilify • Growth mainly driven by the U.S., Maintena MS% Spain and Canada (Quarterly – USD and %) USDm % +16% DKK 2,964m Strong market share gains in Europe 1,600 3
Slide 10: Exceptional revenue and profit growth
FY 2022: Financial update Exceptional revenue and profit growth Key figures Revenue bridge +12% DKKm FY 2022 FY 2021 Δ -4% 18,246 Revenue 18,246 16,299 +12% +9% 16,299 +7% Gross margin 78.3% 77.6% +0.7pp SG&A 7,689 6,818 +13% 2021 Organic FX Hedging 2022 R&D 3,754 3,823 -2% Core EBIT 4,155 3,517 +18
Slide 11: Vyepti moving towards state-of-the-art manufacturing
FY 2022: Financial update Vyepti moving towards state-of-the-art manufacturing Pichia vs. CHO manufacturing Vyepti provision for inventory obsolescence Pichia Pastoris • A DKK 228 million provision for Vyepti inventory obsolescence has been recognized in Cost of sales in 2022 • The provision is a co
Slide 12: Strong growth of more than 40% in both EBIT and EPS
FY 2022: Financial update Strong growth of more than 40% in both EBIT and EPS Reported numbers Comments DKKm 2022 2021 Δ • Underlying organic EBIT growth of +42% EBIT 2,852 2,010 +42% • Decrease in net financial expenses due (in % of revenue) 15.6% 12.3% +3.3pp to lower net interest costs, gain from
Slide 13: Solid operational cash flow while also investing for growth
FY 2022: Financial update Solid operational cash flow while also investing for growth Comments DKKm 2022 2021 • EBIT growth of 42% drives stronger EBIT 2,852 2,010 operational cash flow Adjustments for non-cash items 1,615 1,148 • Changes in net working capital driven by Change in Working capital (4
Slide 14: 2023 financial guidance
FY 2022: Financial update 2023 financial guidance FY 2023 financial guidance FY 2023 housekeeping items FY 2021 FY 2022 DKKm 2023 Guidance Actual Actual Revenue Revenue 16,299 18,246 19.4 ̶ 20.0bn • Continued solid growth of Abilify Maintena, Brintellix/Trintellix EBITDA 3,720 4,663 4.8 ̶ 5.2bn and
Slide 15: Solid growth in revenue and EBITDA expected to continue over the mid-term
FY 2022: Financial update Solid growth in revenue and EBITDA expected to continue over the mid-term Revenue performance (DKKbn) Expected organic development towards mid-term aspiration (3-4 years) Mid-single • Continued double-digit growth for strategic brands digit CAGR in aggregate • Slight erosio
Slide 16: Strong progress in the pipeline
FY 2022: R&D update Strong progress in the pipeline • Brexpiprazole positive phase III data in Agitation in Alzheimer’s Dementia • Priority review ongoing in the U.S. with PDUFA date set for May 10, 2023 • Aripiprazole 2-month formulation (ready-to-use long-term injectable) submitted for regulatory
Slide 17: Brexpiprazole offers an exciting treatment option for patients with AAD
FY 2022: R&D update Brexpiprazole offers an exciting treatment option for patients with Agitation in Alzheimer’s Dementia (AAD) Primary Endpoint: Change from Baseline in Key Secondary Endpoint: Change from CMAI Total (MMRM) (Study 213) Baseline in CGI-S score (MMRM) (Study 213) An estimated 6.5 mill
Slide 18: Brexpiprazole in combination with sertraline in two phase III PTSD trials
FY 2022: R&D update Brexpiprazole, in combination with sertraline, is being evaluated in two phase III PTSD trials High unmet need in Post-traumatic Exploratory PoC study in PTSD4 Phase III program Stress Disorder (PTSD) suggested effects of brexpiprazole Study #1: Flexible-dose study5 in combinatio
Slide 19: Lu AG09222 holds the potential to be first-in-class in migraine prevention
FY 2022: R&D update Lu AG09222 holds the potential to be first-in-class with a differentiated approach to migraine prevention Medical condition Migraine prevention with prior treatment failures Molecule Anti-PACAP* humanized IgG1 antibody – Rich biology provides differentiated approach to migraine p
Slide 20: Lu AF82422 in phase II - Multiple System Atrophy
FY 2022: APPENDIX Lu AF82422 in phase II - Potential first therapy delaying disease progression in Multiple System Atrophy Medical condition Alpha-synucleinopathies: Multiple System Atrophy – A rare, aggressive, disease with a high unmet medical need Molecule Anti alpha-synuclein IgG1 antibody – Bin
Slide 21: Streamlined R&D platform on track to develop the product pipeline
FY 2022: R&D update Streamlined R&D platform on track to develop the product pipeline Biology Project Area Phase I Phase II Phase III Filing/launch Streamlined R&D organization in place focused on four biological clusters for 1) Eptinezumab (anti-CGRP mAb) Migraine prevention SUN-studies PROMISE 1 &
Slide 22: Selected deliverables 2023
FY 2022: SUM-UP Selected deliverables 2023 • Brexpiprazole AAD: FDA approval (The FDA PDUFA date for completion of the review is May 10, 2023 following priority review) • Aripiprazole 2M RTU: Approvals (The FDA PDUFA date for completion of the review is April 27, 2023) • Vyepti: Continue geographica
Slide 23: Sustainability is integral to how we do business
FY 2022: ESG Sustainability is integral to how we do business • +8 million people reached on a daily • 8th consecutive year of achieving a average with our portfolio of products* CDP leadership score • Increased donations to Low-Middle • 100% of electricity for Lundbeck Income Countries Denmark is g
Slide 24: Lundbeck priorities for 2023
FY 2022: SUM-UP Lundbeck priorities for 2023 Continue to deliver solid financial performance Advance progress in our R&D pipeline • Drive growth momentum for our core brands • Approval of brexpiprazole AAD and aripiprazole 2M RTU • Robust cash generative business • Maturing pipeline with promising s
Slide 25: Q&A
Q&A 25 Lundbeck
Slide 26: Appendix
Appendix 26 Lundbeck
Slide 27: Product distribution of revenue – Q4 2022 and FY 2022
FY 2022: APPENDIX Product distribution of revenue – Q4 2022 and FY 2022 DKKm FY 2022 FY 2021 Q4 2022 Q4 2021 Growth Growth in local % of total currencies (FY 2022) TOTAL: Brintellix/Trintellix 4,277 3,526 1,100 961 14% 7% 24% Rexulti/Rxulti 3,890 2,849 1,073 737 46% 26% 21% Abilify Maintena 2,964 2,
Slide 28: Total molecule sales (gross) - USDm
FY 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 29: Volume growth in the U.S. impacted by the pandemic (NRx Count)
FY 2022: APPENDIX Volume growth in the U.S. impacted by the pandemic (NRx Count) +9% 50,000 +8% 400,000 +6% 0% +1% -1% 25,000 200,000 0 0 Q4.18 Q4.19 Q4.20 Q4.21 Q4.22 Q4.18 Q4.19 Q4.20 Q4.21 Q4.22 200,000 +16% 400 +25% +8% +5% +51% 100,000 200 0 0 Q4.18 Q4.19 Q4.20 Q4.21 Q4.22 Q4.20 Q4.21 Q4.22 Sou
Slide 30: Volume growth in the U.S. impacted by the pandemic (TRx Count)
FY 2022: APPENDIX Volume growth in the U.S. impacted by the pandemic (TRx Count) +7% 125,000 +7% 800,000 +8% -3% -1% -3% 100,000 600,000 75,000 400,000 50,000 200,000 25,000 0 0 Q4.18 Q4.19 Q4.20 Q4.21 Q4.22 Q3.18 Q4.19 Q4.20 Q4.21 Q4.22 400,000 800 +45% +15% +7% 300,000 +4% 600 +74% 200,000 400 100
Slide 31: Strong strategic brands growth globally
FY 2022: APPENDIX Strong strategic brands growth globally United States International markets Europe Solid underlying growth +7% +6% +12% in Europe and in LC in LC in LC International markets driven by demand 2021 2022 2021 2022 2021 2022 Strategic brands Strategic brands Strategic brands up 35%* to
Slide 32: Strategic brands are major revenue contributors, continuing strong growth momentum
FY 2022: APPENDIX Strategic brands are major revenue contributors, continuing strong growth momentum Strategic brands* revenue +31% Strategic brands sales growth (+20% in L.C.) (Quarterly - DKKm) 4,000 Europe International Markets United States Global Lundbeck sales in 2022 (67% of total +34% DKK 12
Slide 33: Vyepti: Robust uptake continues
FY 2022: APPENDIX Vyepti: Robust uptake continues Grew 80% in L.C. (104% reported) to DKK 1,004m in FY 2022 Vyepti sales Vyepti sales (Quarterly - DKKm) (FY – DKKm) Launched in the U.S., Australia, 400 1,250 Canada, Denmark, Estonia, Finland, +102% Germany, Kuwait, Singapore, +104% Sweden, Switzerla
Slide 34: Brintellix/Trintellix: Solid underlying performance driven by strong clinical profile
FY 2022: APPENDIX Brintellix/Trintellix: Solid underlying performance driven by strong clinical profile Brintellix/Trintellix sales per region Brintellix/Trintellix (Quarterly - DKKm) (FY – DKKm) Grew 13% (L.C.) to DKK 4.3bn in 2022 1,500 6,000 Europe United States Europe United States International
Slide 35: Rexulti: Growing 37% – an effective drug that is meeting patient needs
FY 2022: APPENDIX Rexulti: Growing 37% – an effective drug that is meeting patient needs Rexulti sales per region** Rexulti sales** Grew 21% in L.C. to DKK 3.9bn (Quarterly - DKKm) (FY - DKKm) in 2022 1,500 4,500 Other regions Other regions +37% Continued solid traction United States United States i
Slide 36: Abilify Maintena: Growing 22% in 2022
FY 2022: APPENDIX Abilify Maintena: Growing 22% in 2022 Grew 16% (L.C.) to DKK 3.0bn in 2022 Abilify Maintena sales per region** Abilify Maintena (Quarterly - DKKm) (FY – DKKm) Global LAI market up 2.4% 1,050 Europe United States 4,000 Europe United States to USD 6.1bn (FY 2022)* International Marke
Slide 37: Cipralex/Lexapro: Sales grew 1% in 2022
FY 2022: APPENDIX Cipralex/Lexapro: Sales grew 1% in 2022 Cipralex/Lexapro Cipralex/Lexapro Grew 1% (down 2% in L.C.) to DKK (Quarterly - DKKm) (FY– DKKm) 2.4bn in 2022 3,000 900 Europe International Markets Europe International Markets 2,500 +1% The biggest markets are -5% Japan, China, South Korea
Slide 38: Sabril: Sales impacted by generic erosion from Q3 2017
FY 2022: APPENDIX Sabril: Sales impacted by generic erosion from Q3 2017 Sabril sales Sabril sales (Quarterly - DKKm) (FY– DKKm) 250 800 200 -3% Down 21% in L.C. (down 9% -9% reported) to DKK 154m in Q4 2022 600 150 Down 14% in L.C. (down 3% 100 reported) to DKK 636m in 2022 400 50 0 200 Q4.20 Q4.21
Slide 39: Onfi: Sales impacted by generic erosion from October 2018
FY 2022: APPENDIX Onfi: Sales impacted by generic erosion from October 2018 Onfi sales Onfi sales (Quarterly - DKKm) (FY – DKKm) 200 700 Down 24% L.C. (1down 1% -16% reported) to DKK 109m in Q4 2022 -11% 100 350 Down 25% L.C. (down 16% reported) to DKK 426m in 2022 0 0 Q4.20 Q4.21 Q4.22 2020 2021 20
Slide 40: Other pharmaceuticals
FY 2022: APPENDIX Other pharmaceuticals Grew 7% in L.C. (up 11% reported) to DKK 741m in Q4 2022 Other pharmaceuticals Other pharmaceuticals (Quarterly - DKKm) (FY – DKKm) Down 9% in L.C. (down 3% reported) to DKK 3.0bn in 2022 1,500 5,400 Around 15 mature products included 4,500 Biggest products ar
Slide 41: Other revenue
FY 2022: APPENDIX Other revenue Other revenue Other revenue (Quarterly - DKKm) (FY – DKKm) Down 49% in L.C. (down 47% 500 150 reported) to DKK 72m in Q4 2022 -47% -20% Down 22% in L.C. (down 20% reported) to DKK 277m in 2022 250 Mostly contract manufacturing to third-party 0 0 Q4.20 Q4.21 Q4.22 2020
Slide 42: Lundbeck is well-positioned through its strong balance sheet
FY 2022: APPENDIX Lundbeck is well-positioned through its strong balance sheet Assets (DKKbn) Liabilities (DKKbn) 37.5 37.5 34.9 4.0 34.7 Inventories 2.8 8.2 Receivables 3.9 3.6 Current liabilities 8.8 Cash and bank balances 2.3 3.5 5.1 Other non-current assets 3.5 3.5 Bank and bond debt 4.8 3.4 Oth
Slide 43: Solid financial foundation from which to execute on our strategy
FY 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 • Inventor
Slide 44: Funding and debt maturity
FY 2022: APPENDIX 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 Invest to Grow stra
Slide 45: 2022 impacted by appreciation of main currencies
FY 2022: APPENDIX 2022 impacted by appreciation of main currencies FY 2022 sales by currency Main currencies** (January 1, 2021 = index 100) EUR Other* 17% 130 21% Spot Lundbeck’s Avg. Avg. Avg. Avg. 125 Jan. hedging 2021 2022 Q4 Q4 19, rate 2021 2022 120 2023 CAD 5% 115 USD 687.62 702 629.13 707.82
Slide 46: Cash generation
FY 2022: APPENDIX Cash generation DKKm Q4 2022 Q4 2021 FY 2022 FY 2021 FY 2020 Cash flows from operating activities 1,287 424 3,519 2,272 3,837 Cash flows from investing activities (532) (319) (1,892) (610) (467) Cash flows from operating and investing 755 105 1,627 1,662 3,370 activities (free cash
Slide 47: Financial position and dividend
FY 2022: APPENDIX Financial position and dividend Dividend (DKK) DKKm 31.12.2022 31.12.2021 3 Dividend Yield (r.h.s.) 5% Intangible assets 22,500 22,750 Other non-current assets 3,540 3,291 4% Current assets 11,412 8,612 3% Assets 37,452 34,653 2% Equity 20,779 18,279 1% Non-current liabilities 8,47
Slide 48: Costs – Full year figures
FY 2022: APPENDIX Costs – Full year figures DKKm 2022 2021 2020 2022 (∆%) 2021 (∆%) Revenue 18,246 16,299 17,672 12% (8%) Cost of sales 3,951 3,648 4,166 8% (12%) Sales & Distribution costs 6,610 5,885 5,946 12% (1%) Administrative expenses 1,079 933 966 16% (3%) R&D costs 3,754 3,823 4,545 (2%) (16
Slide 49: Brexpiprazole offers an exciting treatment option for patients with AAD
FY 2022: APPENDIX Brexpiprazole offers an exciting treatment option for patients with Agitation in Alzheimer’s Dementia (AAD) Prevalence of AAD in community Agitation is a substantial medical challenge for patients living dwelling setting by severity level** with Alzheimer’s Disease and their caregi
Slide 50: Brexpiprazole demonstrated efficacy on primary and key secondary endpoints at Week 12
FY 2022: APPENDIX Brexpiprazole demonstrated efficacy on both the primary (CMAI) and key secondary (CGI-S) endpoints at Week 12 Primary Endpoint: Change from Baseline in CMAI Key Secondary Endpoint: Change from Baseline in Total (MMRM) (Study 213) CGI-S score (MMRM) (Study 213) 0 2 4 6 8 10 12 0 2 4
Slide 51: Both 2 mg and 3 mg doses showed significant improvements vs. placebo on the CMAI
FY 2022: APPENDIX Both 2 mg and 3 mg doses showed statistically significant improvements vs. placebo on the CMAI Study 213: Fixed dose study Mean change from baseline in CMAI Total score by dose 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 0 -4 -4 -8 -8 -12 -12 -16 -16 -20 p=0.024 -20 Placebo (n=116) ** ** Pla
Slide 52: Efficacy of brexpiprazole in study 213 consistent with prior studies 283 and 284
FY 2022: APPENDIX The efficacy of brexpiprazole in study 213 was consistent with the prior studies 283 and 284 Study 283: Fixed dose study Study 284: Flexible dose study (post hoc) Study 213: Fixed dose study Mean change from baseline Mean change from baseline Mean change from baseline in CMAI Total
Slide 53: Brexpiprazole was generally well-tolerated and no new safety signals were observed
FY 2022: APPENDIX Brexpiprazole was generally well-tolerated and no new safety signals were observed Study 213: Adverse events 2% % Patients 0 2 4 6 8 10 Brexpiprazole 3 mg (n=153) Asthenia Brexpiprazole 2 mg (n=73) The only TEAEs with more than 5% incidence in All brexpiprazole (n=226) patients tr
Slide 54: Migraine prevention represents a large and underserved market
FY 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 55: Vyepti: Moving into new frontiers; adapting based on learnings
FY 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 56: Vyepti: Phase III study for treatment of cluster headache
FY 2022: APPENDIX Vyepti: 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 Headache
Slide 57: Lu AF28996: A potentially new oral treatment for Parkinson's
FY 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 58: Lu AG22515 – first neuroimmunology program progressing in phase I
FY 2022: APPENDIX Lu AG22515 – first neuroimmunology program progressing in phase I Medical condition Immune-mediated nervous system disorders Molecular structure of Lu AG22515 (scFv)2-Fab fusion Molecular weight 100 kDA Molecule Anti-CD40L Anti-CD40L Differentiated anti-CD40L antibody-like drug c
Slide 59: Lu AG13909 – first neurohormonal program started clinical development
FY 2022: APPENDIX Lu AG13909 – first neurohormonal program started clinical development HPA axis Medical condition Neurohormonal dysfunctions related to HPA axis Molecule Anti-ACTH humanized IgG1 antibody – First in class mAb with potential to offer a safe and efficacious treatment alternative to pa
Slide 60: Broad MAGLipase program ongoing
FY 2022: APPENDIX Broad MAGLipase program ongoing Lu AG06466 Inhibitor of the monoacylglycerol lipase (MAGL) and selective modulator of the endocannabinoid system CNS penetrant Ongoing phase Ib study • PTSD (n=30)1) Lu AG06474 • Peripherally restricted • Phase I study initiated in August 20212) Ceci
Slide 61: Focus on promising biology
FY 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 62: For more information, please contact Investor Relations
FY 2022: APPENDIX For more information, please contact Investor Relations Number of A-shares 199,148,222 IR contact Number of B-shares 796,592,888 Total 995,741,110 Palle Holm Olesen Listed on the Copenhagen Stock Treasury A shares1 580,280 VP; Head of Investor Relations Exchange since June 18, 1999