63 slides from H. Lundbeck A/s Class A's earnings presentation, Feb 7, 2024
Slide 1: Business update and financial results FY 2023
Business update and financial results FY 2023 Samantha Smith Aquino Living with migraine FY 2023 – 7 February 2024
Slide 2: Company disclaimer
Lundbeck Company disclaimer This presentation, and written information released, or oral statements made, to the public in the future by or on behalf of Lundbeck, may contain forward- looking statements. Such forward-looking statements are based on our current, plans, projections or forecasts of fut
Slide 3: Agenda for today
Lundbeck Agenda for today Overview & conclusion R&D update Charl van Zyl Johan Luthman President & Chief Executive Officer Executive Vice President Head of Research & Development Business update Financial update & outlook Thomas Gibbs Joerg Hornstein Executive Vice President Chief Financial Officer
Slide 4: Overview
Overview Charl van Zyl, President & Chief Executive Officer Ronetta Stokes Living with migraine FY 2023 – 7 February 2024 4
Slide 5: Welcome
Lundbeck Welcome Charl van Zyl President & Chief Executive Officer “We aspire to become a focused innovator developing transformative treatments in neuroscience for patients with high unmet needs while delivering profitable sustainable long-term growth” FY 2023 – 7 February 2024 5 Lundbeck
Slide 6: Strong performance across the business in FY 2023
Lundbeck Strong performance across the business in FY 2023 Strong revenue Double-digit growth Improved Achieved key R&D performance of strategic brands profitability pipeline milestones DKK 20bn DKK 14bn DKK 6bn FDA approvals of Rexulti Revenue 69% of total revenue Adjusted EBITDA AADAD and Abilify
Slide 7: Achieving our ambitions through strategic resource allocation
Lundbeck Achieving our ambitions through strategic resource allocation Investing in key markets and key brands Flexibly adjust commercial spending towards key brands and markets Reassessing manufacturing investments and increasing R&D productivity To be in line with future needed capabilities (e.g.
Slide 8: Our strategic brands supporting our ambition to be a leader in neuroscience
Our strategic brands supporting our ambition to be a leader in neuroscience Thomas Gibbs, Executive Vice President, Head of Lundbeck US Jacob Tolstrup, Executive Vice President, Commercial Operations Carlos Santillana Castillos Living with migraine FY 2023 – 7 February 2024 8
Slide 9: Accelerating growth throughout 2023 in the US
FY 2023 – 7 February 2024 Accelerating growth throughout 2023 in the US Supported by launches in the RoW Global reported revenue Vyepti demand in the US Full investment behind DKKm Vials volume uptake since launch1 the brand continues to 2022 drive growth 2023 +74% CER +66% Number of vials Brand per
Slide 10: Rexulti delivers strong performance in 2023
FY 2023 – 7 February 2024 Rexulti delivers strong performance in 2023 Driven by growing demand in the US Global reported revenue Rexulti demand in the US Continued growth driven DKKm AADAD indication-level claims data1 by increased penetration 2022 +161.3% growth since FDA approval in the AADAD indi
Slide 11: Double-digit growth across key regions
FY 2023 – 7 February 2024 Double-digit growth across key regions Strong performance in Europe and International Markets more than offset the decline in the US Global reported revenue MS% uptake in key markets Strong momentum in DKKm Volume market shares since launch1 Europe and International 2022 Ja
Slide 12: Solid performance across all regions
FY 2023 – 7 February 2024 Solid performance across all regions Driven by the Abilify LAI franchise performance in the US Global reported revenue Abilify Maintena demand Delivering double-digit DKKm Volume market shares as of today1 growth driven by strong 2022 30% MS performance United States 22% 20
Slide 13: R&D update
R&D update Johan Luthman, Executive Vice President, Head of R&D FY 2023 – 7 February 2024 13
Slide 14: Strong progress in the pipeline
FY 2023 – 7 February 2024 Strong progress in the pipeline Lundbeck delivered on its goals for 2023 Brexpiprazole AADAD approved in the US in 2023 and approved in Productive year of 2023 Canada 23 January 2024 2 FDA approvals Brexpiprazole PTSD continued interactions with FDA to determine the next st
Slide 15: Lu AF82422 phase II AMULET trial
FY 2023 – 7 February 2024 Lu AF82422 (anti-α-synuclein) Lu AF82422 phase II AMULET trial A phase II, randomised, double-blind, placebo-controlled exploratory PoC trial in Multiple System Atrophy • IgG1 antibody binds to α-synuclein species and prevents pathological spreading and aggregation • 61 pat
Slide 16: AMULET results support further development of Lu AF82422
FY 2023 – 7 February 2024 Lu AF82422 (anti-α-synuclein) AMULET results support further development of Lu AF82422 Results will be presented at the AD/PD 2024 conference 8 March 2024 • Signals of efficacy were observed across clinical and biomarker endpoints Advancing • Primary endpoint showed slowing
Slide 17: News-rich year ahead
FY 2023 – 7 February 2024 News-rich year ahead Milestone Timing Status Approvals Aripiprazole 2M RTU LAI Europe Q2 2024 Brexpiprazole AADAD Canada Q1 2024 Pivotal read-outs Vyepti Asia (SUNRISE) Q1 2025 Phase III initiations Lu AF82422 (anti-α-synuclein) in MSA Q1 2025 Lu AG09222 (anti-PACAP) in mig
Slide 18: Financial results and outlook
Financial results and outlook Joerg Hornstein, Chief Financial Officer FY 2023 – 7 February 2024 18
Slide 19: Strong revenue and profit growth
FY 2023 – 7 February 2024 Strong revenue and profit growth FY 2023 another record year for Lundbeck Key figures Comments DKKm • Revenue growth is driven by the strong performance across all strategic brands Growth • Adjusted gross margin reflects solid FY 2023 FY 2022 Growth (CER)1 operational perfo
Slide 20: Growth in Adjusted EPS in line with underlying performance
FY 2023 – 7 February 2024 Growth in Adjusted EPS in line with underlying performance Solid improvement in net financials Net profit & EPS Comments DKKm • EBIT growth reflects high revenue and strong operating leverage • Net financials, expenses driven by CVR fair FY 2023 FY 2022 Change value adjustm
Slide 21: Lundbeck is now in a net cash position
FY 2023 – 7 February 2024 Lundbeck is now in a net cash position Strong cash flow leading to continuous deleveraging Cash flows Comments DKKm • Cash inflow from operating activities driven by strong underlying profitability partially offset by higher working capital FY 2023 FY 2022 • Cash outflow fr
Slide 22: Financial outlook for 2024
FY 2023 – 7 February 2024 Financial outlook for 2024 Guidance FY 2024 Other relevant financial information Guidance Total revenue growth at reported1 Around 4%-points lower than CER FY 2023 FY 2024 Adjusted EBITDA growth at reported1 Around 9%-points lower than CER Adjusted gross margin2 88% to 89%
Slide 23: Conclusion
Conclusion Charl van Zyl, Chief Executive Officer FY 2023 – 7 February 2024 23
Slide 24: From capital reallocation to strategic resource allocation
FY 2023 – 7 February 2024 From capital reallocation to strategic resource allocation Several key short-, mid- and long-term actions 2024-26: Focus 2027-29: Scale 2030-33: Accelerate Grow strategic brands Migraine & neuro-rare Organic pipeline franchise breakthroughs Disciplined Partnerships Ongoing
Slide 25: Q&A
Q&A FY 2023 – 7 February 2024 25
Slide 26: Appendix
Appendix FY 2023 – 7 February 2024 26
Slide 27: Building a robust, focused, and de-risked pipeline
FY 2023 – 7 February 2024 Building a robust, focused, and de-risked pipeline A substantial transformation Biology Project Area Phase I Phase II Phase III Filing/Launch Hormonal / Eptinezumab (anti-CGRP mAb)1 Migraine prevention SUN-studies 2 SUN-studies PROMISE 1 & 2 neuropeptide signaling Eptinezum
Slide 28: Unfolding our indication space
FY 2023 – 7 February 2024 Unfolding our indication space Through the lens of our biology clusters, we’re adding new indications to our portfolio From 4 main To focus on 4 biology To unfold our indication To improve disease areas clusters in research space in development our presence Biological psych
Slide 29: Expanding in migraine and headache disorders
FY 2023 – 7 February 2024 Expanding in migraine Expanding in migraine and headache disorders Pursuing the strongest mechanistic approaches Vyepti Preventive migraine treatment and the only treatment administered in 30 min IV 4 x year Anti-PACAP Addressing a gap in migraine treatment Combination appr
Slide 30: A new approach to migraine treatment
FY 2023 – 7 February 2024 Lu AG09222 (anti-PACAP) A new approach to migraine treatment Addressing an urgent need with a differentiated mode of action Perception Cerebral of pain blood vessels 3 Dura Targeting PACAP • Pituitary Adenylate Cyclase Activating 2 Trigeminal Peptide (PACAP) Transmission nu
Slide 31: PACAP clearly differentiates from CGRP
FY 2023 – 7 February 2024 Lu AG09222 (anti-PACAP) PACAP clearly differentiates from CGRP There is a need for additional treatment option Different signaling pathways – Different mode of action Despite the favorable benefit-risk ratio of anti-CGRPs, about 40% of patients do not achieve adequate respo
Slide 32: α-Synuclein aggregation kills cells
FY 2023 – 7 February 2024 Lu AF82422 (anti-α-synuclein) α-Synuclein aggregation kills cells Spreading of aggregated α-synuclein leads to further neuronal death α-Syn begins to aggregate Dying neuron 1 which slowly kills the neuron (dying from α-syn fibrils) monomer oligomer fibrils α-Synuclein Targe
Slide 33: Inhibiting the spread to other cells
FY 2023 – 7 February 2024 Lu AF82422 (anti-α-synuclein) Inhibiting the spread to other cells Lu AF82422 potential first disease-modifying therapy in MSA Released α-syn aggregates Neuron 1 are bound by Lu AF82422 Lu AF82422 increases α-syn 2 clearance by microglia α-Synuclein Lu AF82422 3 The spread
Slide 34: Currently no approved treatment for MSA
FY 2023 – 7 February 2024 Lu AF82422 (anti-α-synuclein) Currently no approved treatment for MSA A rapidly progressing and fatal disease Symptoms The clinical course Common symptoms include: • Slowness of movement, tremor, or stiffness • Clumsiness or lack of coordination Terminal stage • Croaky, qui
Slide 35: Addressing major unmet need in PD
FY 2023 – 7 February 2024 Lu AF28996 (D1/D2 agonist) Addressing major unmet need in PD Lack of dopaminergic neurons lead to motor symptoms Parkinson’s disease Progressive loss of dopaminergic basal ganglia neurons Targeting the basal ganglia • Parkinson’s disease (PD) is Dopaminergic characterized b
Slide 36: An innovative and oral prodrug
FY 2023 – 7 February 2024 Lu AF28996 (D1/D2 agonist) An innovative and oral prodrug Lu AF28996 provides a new solution for patients and specialists Broad-acting dopamine D1/D2 receptor agonist providing continuous dopaminergic activation Improved Improved Improved Lu AF28996 efficacy tolerability co
Slide 37: Continuous receptor stimulation
FY 2023 – 7 February 2024 Lu AF28996 (D1/D2 agonist) Continuous receptor stimulation Lu AF28996 offers continuous D1 and D2 receptor stimulation An innovative pro-drug Mechanism Lu AF28996 Metabolites Continuous exposure achieved by back-and-forth conversion of metabolites serving as a reservoir Pla
Slide 38: High potential in a range of disorders
FY 2023 – 7 February 2024 Lu AG22515 (anti-CD40L) High potential in a range of disorders The benefits of CD40L blockage Reduces auto- antibodies Blocks immune responses Reduces inflammation Targeting CD40L Increases • Blocking CD40L inhibits both B- and T- B-cell regulatory T-cells cell activations
Slide 39: A first-in-class neurohormonal asset
FY 2023 – 7 February 2024 Lu AG13909 (anti-ACTH) A first-in-class neurohormonal asset Early clinical proof of mechanism established Targeting the HPA axis Hypothalamus • The Hypothalamic Pituitary Adrenal (HPA) axis governs numerous Pituitary gland physiological and pathophysiological functions CRH
Slide 40: A selective dual modulator
FY 2023 – 7 February 2024 MAGLi programs A selective dual modulator MAGLi balances neurotransmission Restore neuronal transmission 2-Arachidonoylglycerol (2-AG) Reduce neuro-inflammation Targeting MAGL • MAGL is an enzyme that controls the MAGL MAGLi level of circulating endocannabinoid (Monoacylgly
Slide 41: Revenue overview FY 2023
FY 2023 – 7 February 2024 Revenue overview FY 2023 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 FY 2023 FY 2023 DKKm Strategic brands Mature brands DKKm United States Europe International Markets 20,000 +8% 20,000 +8% 15,000 15,000 +16% +11% 10,000 10,
Slide 42: Revenue overview Q4 2023
FY 2023 – 7 February 2024 Revenue overview Q4 2023 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 Q4 2023 Q4 2023 DKKm Strategic brands Mature brands DKKm United States Europe International Markets 5,000 +6% 5,000 +6% 4,500 4,500 4,000 4,000 3,500 3,500
Slide 43: Product distribution of revenue & YoY growth
FY 2023 – 7 February 2024 Product distribution of revenue & YoY growth Growth % of total Growth % of total DKKm FY 2023 FY 2022 Growth Q4 2023 Q4 2022 Growth (CER) FY 2023 (CER) Q4 2023 Rexulti® 4,525 3,890 16% 20% 23% 1,216 1,073 13% 21% 24% Brintellix®/Trintellix® 4,324 4,277 1% 5% 22% 1,117 1,100
Slide 44: Strategic brands
FY 2023 – 7 February 2024 Strategic brands Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Strong performance across the strategic brands reaching DKK 13.7bn in FY 2023 and DKK +16% 3.6bn in Q4 2023, representing a growth of 16% 15,000 CER 4,500 (+13% reported) and 16% (+10%
Slide 45: Rexulti
FY 2023 – 7 February 2024 Rexulti Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 20% (+16% reported) and reached DKK 4.5bn in FY 2023 +20% +21% Grew by 21% (+13% reported) and reached 5,000 1,300 CER CER DKK 1.2bn in Q4 2023 1,200 4,500 Strong demand growth continue
Slide 46: Brintellix/Trintellix
FY 2023 – 7 February 2024 Brintellix/Trintellix Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 5% (+1% reported) and reached DKK 4.3bn in FY 2023 +5% CER +6% Grew by 6% (+2% reported) and reached DKK 4,500 1,200 CER 1.1bn in Q4 2023 1,100 4,000 Continued robust dema
Slide 47: Abilify LAI franchise
FY 2023 – 7 February 2024 Abilify LAI franchise Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 10% (+8% reported) and reached DKK 3.2bn in FY 2023 +10% Grew by 5% (+2% reported) and reached DKK 3,500 900 +5% CER 0.8bn in Q4 2023 CER 800 Robust traction in volume sha
Slide 48: Vyepti
FY 2023 – 7 February 2024 Vyepti Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 74% (+69% reported) and reached DKK 1.7bn in FY 2023 +59% CER Grew by 59% (+49% reported) and reached 2,000 500 +74% DKK 0.5bn in Q4 2023 CER Launched in the US, Australia, Canada, Denma
Slide 49: Cipralex/Lexapro
FY 2023 – 7 February 2024 Cipralex/Lexapro Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Down by 4% (-10% reported) and reached DKK 2.1bn in FY 2023 -4% CER Down by 3% (-11% reported) and reached DKK 2,500 800 -3% 0.4bn in Q4 2023 CER The biggest markets are China, South K
Slide 50: Sabril
FY 2023 – 7 February 2024 Sabril Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Down by 47% (-47% reported) and reached DKK 0.3bn in FY 2023 Down by 86% (-88% reported) and reached 800 250 DKK 0.0bn in Q4 2023 -47% CER Sales impacted by mainly generic erosion and 200 supply
Slide 51: Other pharmaceuticals
FY 2023 – 7 February 2024 Other pharmaceuticals Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Down by 2% (-5% reported) and reached DKK 3.2bn in FY 2023 Down by 18% (-23% reported) and reached 6,000 1,600 DKK 0.7bn in Q4 2023 5,500 Around 15 mature products included 5,000
Slide 52: Other revenue
FY 2023 – 7 February 2024 Other revenue Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 18% (+18% reported) and reached DKK 0.3bn in FY 2023 Grew by 91% (+86% reported) and reached 500 150 +91% DKK 0.1bn in Q4 2023 CER Mostly contract manufacturing to third-party +18
Slide 53: FY 2023: EBIT & Adjusted EBITDA
FY 2023 – 7 February 2024 FY 2023: EBIT & Adjusted EBITDA DKKm FY 2023 FY 2022 Change Change (CER)1 Revenue 19,912 18,246 9% 8% Gross profit 15,427 14,295 8% 6% thereof adjustments 327 228 43% 37% thereof depreciation/amortization 1,826 1,610 13% 14% Sales and distribution costs 7,482 6,610 13% 18%
Slide 54: Q4 2023: EBIT & Adjusted EBITDA
FY 2023 – 7 February 2024 Q4 2023: EBIT & Adjusted EBITDA DKKm Q4 2023 Q4 2022 Change Change (CER)1 Revenue 4,978 4,680 6% 6% Gross profit 3,770 3,501 8% 6% thereof adjustments - 228 - - thereof depreciation/amortization 467 460 2% 4% Sales and distribution costs 2,185 1,870 17% 25% thereof adjustme
Slide 55: Full year figures: EBIT and Adjusted EBITDA
FY 2023 – 7 February 2024 Full year figures: EBIT and Adjusted EBITDA FY 2023 Change DKKm FY 2023 FY 2022 ´FY 2021 FY 2023 Change (CER)1 Revenue 19,912 18,246 16,299 9% 8% Cost of sales 4,485 3,951 3,648 14% 17% Sales & Distribution (S&D) costs 7,482 6,610 5,885 13% 18% Administrative expenses 1,293
Slide 56: FY 2023: Overall Adjusted EBITDA reconciliation
FY 2023 – 7 February 2024 FY 2023: Overall Adjusted EBITDA reconciliation DKKm FY 2023 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Profit from operations (EBIT) 3,195 1,233 840 891 231 Amortization of product rights 1,559 404 385 384 386 Depreciation and amortization 453 107 109 110 127 EBITDA 5,207 1,744 1,334
Slide 57: Full year figures: Revenue & Adjusted EBITDA at CER
FY 2023 – 7 February 2024 Full year figures: Revenue & Adjusted EBITDA at CER DKKm FY 2023 FY 2022 Total revenue (IFRS) 19,912 18,246 Effects from hedging 137 (588) Total revenue (IFRS) before hedging 19,775 18,834 Effects from exchange rate (645) 1,364 Total revenue at CER 20,420 17,470 Increase/(D
Slide 58: Slight weakening of key currencies in 2023
FY 2023 – 7 February 2024 Slight weakening of key currencies in 2023 Sales by currency Main currencies2 Comments FY 2023 1 January 2022 = index 100 • ~83% of sales in non-EUR currencies 120 • USD directly represents ~52% of sales FY 115 2023 CAD 5% CNY 110 • Three main currencies make up ~65% of net
Slide 59: Lundbeck is well-positioned through its strong balance sheet
FY 2023 – 7 February 2024 Lundbeck is well-positioned through its strong balance sheet Assets Liabilities Comments DKKbn DKKbn • Inventories driven by Vyepti and Xenazine 37.5 37.4 37.5 37.4 • Intangible assets decrease driven mainly by product rights amortization Inventories Current liabilities • R
Slide 60: Financial position and dividend
FY 2023 – 7 February 2024 Financial position and dividend Financial position Dividend DKKm DKK • Proposed dividend pay-out of DKK 0.70 per share to be paid out for 2023, corresponding to 31.12.2023 31.12.2022 a pay-out ratio of ~30% Intangible assets 20,692 22,500 • A total of DKK 697 million and a
Slide 61: Cash generation
FY 2023 – 7 February 2024 Cash generation DKKm FY 2023 FY 2022 ´FY 2021 Q4 2023 Q4 2022 Cash flows from operating activities 4,080 3,519 2,272 941 1,287 Cash flows from investing activities (498) (1,892) (610) (136) (532) Cash flows from operating and investing activities (free cash flow) 3,582 1,62
Slide 62: Strong cash flow leading to continuous deleveraging
FY 2023 – 7 February 2024 Strong cash flow leading to continuous deleveraging Net cash, Net debt and Net debt/EBITDA Solid financial foundation DKKm from which to execute on our strategy Net cash/(net debt) Net debt/EBITDA 8,000 2.0 • FY 2023 cash flow negatively impacted 6,635 by: Dividend increase
Slide 63: For more information, please contact Investor Relations
FY 2023 – 7 February 2024 For more information, please contact Investor Relations Number of A-shares 199,148,222 IR contacts Number of B-shares 796,592,888 Palle Holm Olesen Vice President, Head of Investor Relations Total 995,741,110 Mobile: +45 3083 2426 Listed on the Copenhagen Stock Treasury A s