H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — H Lundbeck A/S B — Q1 2024 Earnings Presentation
65 slides from H. Lundbeck A/s Class A's earnings presentation, May 15, 2024
Slide 1: Business update and financial results Q1 2024
Business update and financial results Q1 2024 Samantha Smith Aquino Living with migraine Q1 2024 – 15 May 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 Q1 2024 – 15 May 2024 4
Slide 5: Towards becoming a Focused Innovator
Lundbeck Towards becoming a Focused Innovator Secure stable Lead with focused Deliver sustainable long-term growth innovation profitability Boost strategic brands Rebalance investments Confirm 30-32% adjusted EBITDA Investing in Vyepti and Rexulti to ensure innovation mid-term guidance* towards mid-
Slide 6: Robust performance across the business in Q1 2024
Lundbeck Robust performance across the business in Q1 2024 Solid operational Strong growth Achieved key R&D Executive Leadership performance of strategic brands pipeline milestones team in place DKK 5.3bn +7% DKK 3.8bn EU approval of Abilify Execute on ambition to Revenue 71% of total revenue Mainte
Slide 7: Lundbeck's Executive Management team in place
Lundbeck Lundbeck’s Executive Management team in place President & Chief Executive Officer EVP, Head of R&D Charl van Zyl Johan Luthman President & Chief Executive Officer EVP, Head of Lundbeck US CFO, EVP Corporate Functions Thomas Gibbs Joerg Hornstein EVP, Europe & International Markets EVP, Prod
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 Michala Fischer-Hansen, Executive Vice President, Europe & International Markets Carlos Santillana Castillos Living with migraine Q1 2024 – 15 May 2024 8
Slide 9: Continued strong growth in the U.S. during Q1 2024
Q1 2024 – 15 May 2024 Continued strong growth in the U.S. during Q1 2024 Supported by robust adoption in key prioritized markets Global reported revenue Vyepti demand in the U.S. Full investment DKKm Vials volume uptake since launch behind the brand Q1 2023 continues to drive growth Q1 2024 +79% CER
Slide 10: Rexulti delivers high performance in Q1 2024
Q1 2024 – 15 May 2024 Rexulti delivers high performance in Q1 2024 U.S. TRx growth of 15.8% in Q1 2024 versus prior year Global reported revenue Rexulti demand in the U.S. Continued growth mainly DKKm AADAD indication-level claims data driven by increased Q1 2023 penetration in AADAD Q1 2024 +205% g
Slide 11: Rexulti AADAD volume increasingly important to Rexulti growth
Q1 2024 – 15 May 2024 Rexulti AADAD volume becoming increasingly important to overall Rexulti growth through 2024 Rexulti Monthly Claims Volume by Indication Rexulti TRx growth AADAD Launch - January 2024 observed across the brand 18.000 +15.9% growth 100.000 since FDA approval Brand performance 16.
Slide 12: Double-digit growth across key regions
Q1 2024 – 15 May 2024 Double-digit growth across key regions Strong performance mainly driven by accelerated growth in Europe Global reported revenue Growth in key markets Strong momentum in DKKm MAT volume growth Europe and International Q1 2023 Market growth Markets Q1 2024 Brintellix growth +11%
Slide 13: Solid performance across all regions
Q1 2024 – 15 May 2024 Solid performance across all regions Driven by double digit value growth in key markets Global reported revenue Growth in key markets Delivering double-digit DKKm MAT volume growth growth driven by strong Q1 2023 Market growth performance Q1 2024 Abilify LAI franchise +10% CER
Slide 14: R&D update
R&D update Johan Luthman, Executive Vice President, Head of R&D Q1 2024 – 15 May 2024 14
Slide 15: The R&D pipeline is off to a strong start in 2024
Q1 2024 – 15 May 2024 The R&D pipeline is off to a strong start in 2024 Key regulatory activities and major events in Phase II The European Commission approved Abilify Maintena® 960 mg (2M RTU LAI formulation) Brexpiprazole: FDA submission of sNDA for PTSD; data presentation at ASCP in May Lu AG0922
Slide 16: Lu AG09222: Anti-PACAP phase IIb PROCEED trial initiated
Q1 2024 – 15 May 2024 Lu AG09222 (anti-PACAP) Lu AG09222: Anti-PACAP phase IIb PROCEED trial initiated Progressing into full development with first-in-class mechanism for migraine prevention Establishing dose range efficacy Screening Double-blind placebo-controlled for s.c. development 29 days 12 we
Slide 17: Lu AF82422 slowing clinical progression in MSA patients
Q1 2024 – 15 May 2024 Lu AF82422 (anti-α-synuclein) Lu AF82422 results showed a consistent trend towards slowing clinical progression in MSA patients Results presented at the AD/PD 2024 conference 8 March 2024 Modified UMSARS showed 27% slowing of clinical Progressing with first-in-class progression
Slide 18: Brexpiprazole in PTSD – submitted for regulatory review
Q1 2024 – 15 May 2024 Brexpiprazole - PTSD Brexpiprazole in PTSD – submitted for regulatory review and upcoming data presentation Awaiting FDA validation and filing of sNDA Brexpiprazole and sertraline combination for PTSD • Positive PoC trial (#061) and pivotal trial #071: Brexpiprazole in combinat
Slide 19: Good progress in internal pipeline
Q1 2024 – 15 May 2024 Good progress in internal pipeline 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
Slide 20: Financial results and outlook
Financial results and outlook Joerg Hornstein, Chief Financial Officer Q1 2024 – 15 May 2024 20
Slide 21: Robust revenue growth
Q1 2024 – 15 May 2024 Robust revenue growth Driven by strong growth of strategic brands Key figures Comments DKKm • Revenue growth is driven by the strong performance across all strategic brands Growth Growth • Adjusted gross margin reflecting mainly Q1 2024 Q1 2023 (CER)1 (DKK) higher sales and a f
Slide 22: Growth in Adjusted EPS in line with underlying performance
Q1 2024 – 15 May 2024 Growth in Adjusted EPS in line with underlying performance Solid improvement in net financials Net profit & EPS Comments DKKm • EBIT growth reflects higher revenue and lower product rights amortization, offset by higher operating expenses as well as Vyepti inventory obsolescenc
Slide 23: Lundbeck continues to be in a net cash position
Q1 2024 – 15 May 2024 Lundbeck continues to be in a net cash position Strong cash flow leading to continuous deleveraging Cash flow Comments DKKm • Cash inflow from operating activities driven by a combination of higher EBIT, lower inventory build-up and lower short-term liabilities Q1 2024 Q1 2023
Slide 24: Financial outlook for 2024 reiterated
Q1 2024 – 15 May 2024 Financial outlook for 2024 reiterated FX impact reduced leaving room for a slight upgrade of expected reported growth Guidance FY 2024 Other relevant financial information Guidance Total revenue growth at reported1 Around 3%-points lower than CER Q1 2024 FY 2024 Adjusted EBITDA
Slide 25: Conclusion
Conclusion Charl van Zyl, President & Chief Executive Officer Q1 2024 – 15 May 2024 25
Slide 26: Solid business momentum as we become a Focused Innovator
Q1 2024 – 15 May 2024 Solid business momentum as we become a Focused Innovator Accelerating pipeline momentum, disciplined investment to fuel growth Secure stable long-term growth • Robust Q1 sales growth provides room for investments in sales & promotion and R&D • Maximizing strategic brands - key
Slide 27: Q&A
Q&A Q1 2024 – 15 May 2024 27
Slide 28: Appendix
Appendix Q1 2024 – 15 May 2024 28
Slide 29: Building a robust, focused, and de-risked pipeline
Q1 2024 – 15 May 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 2 SUN-studies SUN-studies PROMISE 1 & 2 neuropeptide signaling Eptinezumab (
Slide 30: Unfolding our indication space
Q1 2024 – 15 May 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 psychiatr
Slide 31: Expanding in migraine and headache disorders
Q1 2024 – 15 May 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 approach
Slide 32: A new approach to migraine treatment
Q1 2024 – 15 May 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 nucleu
Slide 33: PACAP clearly differentiates from CGRP
Q1 2024 – 15 May 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 response
Slide 34: α-Synuclein aggregation kills cells
Q1 2024 – 15 May 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 Targeting
Slide 35: Inhibiting the spread to other cells
Q1 2024 – 15 May 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 of a
Slide 36: Currently no approved treatment for MSA
Q1 2024 – 15 May 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, quiveri
Slide 37: Addressing major unmet need in PD
Q1 2024 – 15 May 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 by a
Slide 38: An innovative and oral prodrug
Q1 2024 – 15 May 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 conven
Slide 39: Continuous receptor stimulation
Q1 2024 – 15 May 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 Plasma
Slide 40: High potential in a range of disorders
Q1 2024 – 15 May 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 with
Slide 41: A first-in-class neurohormonal asset
Q1 2024 – 15 May 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 • St
Slide 42: A selective dual modulator
Q1 2024 – 15 May 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 (Monoacylglycero
Slide 43: Revenue overview Q1 2024
Q1 2024 – 15 May 2024 Revenue overview Q1 2024 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 Q1 2024 Q1 2024 DKKm Strategic brands Mature brands DKKm United States Europe International Markets 5.500 +7% 5.500 +7% 5.000 5.000 4.500 4.500 4.000 4.000 3.50
Slide 44: Revenue overview FY 2023
Q1 2024 – 15 May 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 10.000
Slide 45: Product distribution of revenue & YoY growth
Q1 2024 – 15 May 2024 Product distribution of revenue & YoY growth Growth Growth % of total DKKm Q1 2024 Q1 2023 (CER) (DKK) Q1 2024 Brintellix®/Trintellix® 1,168 1,077 11% 8% 22% Rexulti® 1,115 1,060 7% 5% 21% Abilify Maintena®/Asimtufii 859 785 10% 9% 16% Vyepti® 617 351 79% 76% 12% Strategic bran
Slide 46: Strategic brands
Q1 2024 – 15 May 2024 Strategic brands Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Strong performance across the strategic brands reaching DKK 3.8bn in Q1 2024, representing a +16% growth of 17% (+15% DKK) and equivalent to 15,000 CER 4,500 71% of total revenue +17% 13,5
Slide 47: Brintellix/Trintellix
Q1 2024 – 15 May 2024 Brintellix/Trintellix Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 11% (+8% DKK) and reached DKK 1.2bn in Q1 2024 +5% +11% CER CER Continued robust demand in most markets 4,500 1,200 1,100 4,000 1,000 3,500 900 3,000 800 700 2,500 600 2,000 5
Slide 48: Rexulti
Q1 2024 – 15 May 2024 Rexulti Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 7% (+5% DKK) and reached DKK 1.1bn in Q1 2024 +7% +20% CER Demand growth continues in the U.S. and other 5,000 1,300 CER regions 1,200 4,500 1,100 4,000 1,000 3,500 900 3,000 800 700 2,500
Slide 49: Abilify LAI franchise
Q1 2024 – 15 May 2024 Abilify LAI franchise Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 10% (+9% DKK) and reached DKK 0.9bn in Q1 2024 +10% +10% In April 2023, Abilify Asimtufii got FDA approval 3,500 CER 900 CER In March 2024 Abilify Maintena® 960 mg 800 (aripip
Slide 50: Vyepti
Q1 2024 – 15 May 2024 Vyepti Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 79% (+76% DKK) and reached DKK 0.6bn in Q1 2024 Launched in the U.S., Australia, Canada, 2,000 700 +74% +79% Denmark, Estonia, Finland, Germany, Kuwait, CER CER Singapore, Sweden, Switzerlan
Slide 51: Cipralex/Lexapro
Q1 2024 – 15 May 2024 Cipralex/Lexapro Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 1% (-7% DKK) and reached DKK 0.6bn in Q1 2024 -4% CER +1% The biggest markets are China, Saudi Arabia, 2,500 700 CER Brazil, South Korea and Italy in Q1 2024 600 The patent expired
Slide 52: Other pharmaceuticals
Q1 2024 – 15 May 2024 Other pharmaceuticals1 Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Down by 18% (-21% DKK) and reached DKK 0.9bn in Q1 2024 Around 15 mature products included 7.000 1.600 6.500 Biggest products are Azilect, Cipramil, Cisordinol, 6.000 Deanxit, Ebixa,
Slide 53: Other revenue
Q1 2024 – 15 May 2024 Other revenue Full year reported revenue Quarterly reported revenue Comments DKKm DKKm Grew by 11% (+11% DKK) and reached DKK 0.1bn in Q1 2024 +11% Mostly contract manufacturing to third-party 500 150 CER +18% CER 100 250 50 0 0 FY 2020 FY 2021 FY 2022 FY 2023 Q1.21 Q1.22 Q1.23
Slide 54: Q1 2024: EBIT & Adjusted EBITDA
Q1 2024 – 15 May 2024 Q1 2024: EBIT & Adjusted EBITDA Change Change DKKm Q1 2024 Q1 2023 (CER)1 (DKK) Revenue 5,288 5,044 7% 5% Gross profit 4,279 4,003 9% 7% thereof adjustments - 101 - - thereof depreciation/amortization 421 464 (9%) (9%) Sales and distribution costs 1,789 1,673 9% 7% thereof depr
Slide 55: Full year figures: EBIT & Adjusted EBITDA
Q1 2024 – 15 May 2024 Full year figures: EBIT & Adjusted EBITDA ∆ FY 2023 ∆ FY 2023 DKKm FY 2023 FY 2022 FY 2021 (CER)1 (DKK) Revenue 19,912 18,246 16,299 8% 9% Gross profit 15,427 14,295 12,651 6% 8% thereof adjustments 327 228 37 37% 43% thereof depreciation/amortization 1,826 1,610 1,485 14% 13%
Slide 56: Q1 2024 and FY 2023: Overall Adjusted EBITDA reconciliation
Q1 2024 – 15 May 2024 Q1 2024 and FY 2023: Overall Adjusted EBITDA reconciliation DKKm Q1 2024 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Profit from operations (EBIT) 1,278 1,233 840 891 231 Amortization of product rights 368 404 385 384 386 Depreciation and amortization 100 107 109 110 127 EBITDA 1,746 1,744
Slide 57: FY 2023: Overall Adjusted EBITDA reconciliation
Q1 2024 – 15 May 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 1,3
Slide 58: Revenue & Adjusted EBITDA at CER
Q1 2024 – 15 May 2024 Full year figures: Revenue & Adjusted EBITDA at CER DKKm Q1 2024 FY 2023 Total revenue (IFRS) 5,288 19,912 Effects from hedging (9) 137 Total revenue (IFRS) before hedging 5,297 19,775 Effects from exchange rate (154) (645) Total revenue at CER 5,451 20,420 Increase/(Decrease)
Slide 59: Revenue & Adjusted EBITDA at CER
Q1 2024 – 15 May 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/(Decre
Slide 60: Less volatility in key currencies in 2024 YTD
Q1 2024 – 15 May 2024 Less volatility in key currencies in 2024 YTD Sales by currency Main currencies2 Comments FY 2023 29 December 2022 = index 100 • ~83% of sales in non-EUR currencies 110 • USD directly represents ~52% of sales FY 2023 CAD 105 5% CNY • Three main currencies make up ~60% of net 10
Slide 61: Lundbeck is well-positioned through its strong balance sheet
Q1 2024 – 15 May 2024 Lundbeck is well-positioned through its strong balance sheet Assets Liabilities Comments DKKbn DKKbn • Inventories driven by Vyepti and Xenazine 37.4 37.9 37.4 37.9 • Intangible assets decrease driven mainly by product rights amortization Inventories • ROIC improved from 10.5%
Slide 62: Financial position and dividend
Q1 2024 – 15 May 2024 Financial position and dividend Financial position Dividend DKKm DKK • Proposed dividend pay-out of DKK 0.70 per share has been paid out for 2023, 31.03.2024 31.12.2023 corresponding to a pay-out ratio of ~30% Intangible assets 20,607 20,692 • A total of DKK 697 million and a y
Slide 63: Cash generation
Q1 2024 – 15 May 2024 Cash generation DKKm Q1 2024 Q1 2023 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 961 378 4,080 3,519 2,272 Cash flows from investing activities (94) (77) (498) (1,892) (610) Cash flows from operating and investing activities (free cash flow) 867 301 3,582 1,627
Slide 64: Strong cash flow leading to continuous deleveraging
Q1 2024 – 15 May 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 • Q1 2024: Cash flow negatively impacted by 6,635 • Dividend amounting
Slide 65: For more information, please contact Investor Relations
Q1 2024 – 15 May 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 share