H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — H Lundbeck A/S B — 9M 2024 Earnings Presentation
70 slides from H. Lundbeck A/s Class A's earnings presentation, Nov 13, 2024
Slide 1: Business update & financial results 9M 2024
Business update & financial results 9M 2024 Martha Living with depression
Slide 2: Safe Harbor/Forward-Looking Statements
Safe Harbor/Forward-Looking Statements 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 stateme
Slide 3: Important Information for Investors and Security Holders
IMPORTANT INFORMATION FOR INVESTORS AND SECURITY HOLDERS This presentation is not an offer to buy or the solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Longboard common stock have been made pursuant to a tender offer statement on Schedule TO, contain
Slide 4: Agenda for today
Agenda for today Overview & Conclusion Charl van Zyl President & Chief Executive Officer Business Update Thomas Gibbs Executive Vice President Head of Lundbeck US Michala Fischer-Hansen Executive Vice President Europe & International Markets R&D Update Johan Luthman Executive Vice President Head of
Slide 5: Strong performance across the business in 9M 2024
Strong performance across the business in 9M 2024 HSR waiting period has expired and Longboard deal remains on track for an expected December 2024 closing Solid operational Strong growth Achieved key R&D performance of strategic brands pipeline milestones • Revenue grew 13% to DKK 16.5bn • Accelerat
Slide 6: 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 6 9M 2024 – November 13, 2024
Slide 7: Rexulti delivers strong performance in 9M 2024
Rexulti delivers strong performance in 9M 2024 U.S. TRx growth of 20% in Q3 2024 versus prior year Global reported revenue Monthly claims volume by indication Continued growth mainly DKKm AADAD Launch – July 2024 driven by increased +16% CER 24,000 120,000 penetration in AADAD in US +14% CER DKK 3.8
Slide 8: Continued very strong growth momentum
Continued very strong growth momentum Growth supported by robust adoption in key prioritized markets Global reported revenue Vyepti demand in the U.S. Full investment behind the brand DKKm Vials volume uptake since launch1 continues to drive growth +76% CER Brand performance DKK 2.116m +66% CER • Th
Slide 9: Strong performance across key markets
Strong performance across key markets Continued double digit growth in most markets in E&IO with 10 years since launch Global reported revenue Growth in key markets Strong momentum DKKm MAT Volume growth in Europe and International +14% CER Markets DKK 3.576m Australia 5% 15% Brand performance DKK 3
Slide 10: Solid performance contributed by all markets
Solid performance contributed by all markets aLAI accounts for ~38% of total market value and continues to outgrow oral atypicals Global reported revenue Growth in key markets Double-digit growth driven DKKm MAT volume growth by strong performance +10% CER Brand performance Australia 2% DKK 2.618m 1
Slide 11: R&D update and outlook
R&D update and outlook Johan Luthman, Executive Vice President, Head of R&D 11 9M 2024 – November 13, 2024
Slide 12: The R&D pipeline progress continues
The R&D pipeline progress continues Key regulatory activities and major events Bexicaserin • Phase III program: DEEp SEA (n=160 DS patients1) has been started by Longboard; DEEp OCEAN starting up2 Lu AG22515 (CD40L blocker) • PoC study initiated in Q3 2024 in TED Amlenetug • MASCOT phase III trial i
Slide 13: The SUN Program - Adding to Vyepti's strong profile
The SUN Program - Adding to Vyepti’s strong profile Adaptive program utilizing learnings on geography and trial population U.S. & Europe PROMISE I/II, RELIEF, DELIVER, PREVAIL and emerging real-world evidence Efficacious Asia program Fast SUNLIGHT, SUNRISE and SUNSET extention Sustained Effective in
Slide 14: Vyepti met the primary endpoint in SUNRISE
Vyepti met the primary endpoint in SUNRISE All key secondary endpoints met as well SUNRISE trial design Change from baseline in MMD • Primary endpoint showing statistically significant reductions in MMD, with both 4-week intervals (FAS, MRMM) doses showing robust separation from placebo over weeks 1
Slide 15: SUNRISE enables broader access of Vyepti in Asia
SUNRISE enables broader access of Vyepti in Asia From Early Patient Experience Pilot Programs in China to broader filing in Asia >130 patients treated with Vyepti under “Urgent medical need” pilot initiative in Hainan since 2023 Approval Great Bay Area Sun Yat-sen Memorial Hospital 2026/27 2025 Fili
Slide 16: Financial results and outlook
Financial results and outlook Joerg Hornstein, Chief Financial Officer 16 9M 2024 – November 13, 2024
Slide 17: Accelerating growth of strategic brands
Accelerating growth of strategic brands Continued strong growth momentum driven by strategic brands constituting 74% of sales Key figures Comments DKKm • Revenue: continued strong performance across 9M 2024 9M 2023 Change (CER) 1 Change (DKK) all strategic brands • Adjusted gross margin: higher raw
Slide 18: Adjusted EPS growth in line with underlying performance
Adjusted EPS growth in line with underlying performance Solid improvement in the financials Net profit & EPS Comments DKKm • EBIT: Reflecting the strong growth partially 9M 2024 9M 2023 Change (DKK) offset by higher OPEX as well as the effect of the impairment loss EBIT 3,093 2,964 4% EBIT margin 18
Slide 19: Lundbeck in a strong net cash position
Lundbeck in a strong net cash position Strong cash flow provide flexibility Cash flow Comments DKKm • Cash inflow from operating activities: a 9M 2024 9M 2023 combination of higher EBIT, lower inventory EBIT 3,093 2,964 build-up and short-term liabilities Adjustments for non-cash items 2,324 1,888 •
Slide 20: Raised lower end of financial guidance range for 2024
Raised lower end of financial guidance range for 2024 Expected deal closure of Longboard reflected in updated soft guidance parameters Guidance FY2024 Other relevant financial information Total revenue growth at reported 1 Around 3%-points lower than CER Previous Revised guidance guidance Adjusted E
Slide 21: Conclusion
Conclusion Charl van Zyl, President & Chief Executive Officer 21 9M 2024 – November 13, 2024
Slide 22: Lundbeck becoming a Focused Innovator
Lundbeck becoming a Focused Innovator Accelerating pipeline momentum, disciplined investment to fuel growth Secure long-term Lead with Deliver sustainable growth focused innovation profitability • Robust sales growth provides • Continue R&D progression for mid- • Confidence in FY2024 guidance room f
Slide 23: Q&A
Q&A 23 9M 2024 – November 13, 2024
Slide 24: Appendix
Appendix 24 9M 2024 – November 13, 2024
Slide 25: A news-rich period ahead
A news-rich period ahead Key events in pipeline progression Project Area Milestones Pivotal Eptinezumab (anti-CGRP mAb) Migraine prevention (SUNRISE) Read-out Q4 2024 Pivotal Pivotal Bexicaserin1 (5-HT2C agonist) DEEs (DEEp program) Initiation Q4 2024 Read-out 2027 Pivotal Amlenetug (anti-α-synuclei
Slide 26: Building a robust, focused, and de-risked pipeline
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 1 CHRONICLE3 Eptinezumab (anti-CGR
Slide 27: Unfolding our indication space
Unfolding our indication space Through the lens of our biology clusters, we’re adding new indications to our portfolio From To 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 psychiatry Depression S
Slide 28: Expanding in migraine and headache disorders
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 To improve Addressing a gap in migraine treatment our presence Combination approaches Early exploratory
Slide 29: A new approach to migraine treatment
A new approach to migraine treatment Adressing an urgent need with a differentiated mode of action Perception Cerebral blood of pain vessels 3 Targeting PACAP Dura • Pituitary Adenylate Cyclase Activating Peptide (PACAP) • The PACAP peptide and its receptors are Transmission Trigeminal nucleus expre
Slide 30: PACAP clearly differentiates from CGRP
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 Compared to CGRP, experimentally introduced CG
Slide 31: Strong unmet need across broad range of epilepsy indications
Strong unmet need across broad range of epilepsy indications Insufficient treatment options available for epilepsy patients with drug-resistant seizures Epilepsy populations Classifying epilepsy Developmental and epileptic Unmet needs remain Based on type of seizure encephalopathies and etiology Onl
Slide 32: Majority of DEEs have no approved treatment options
Majority of DEEs have no approved treatment options U.S. patient population of approximately 220,000 and half not served by licensed therapies Sizable opportunities across all DEEs Bexicaserin Pipeline in a mechanism DEEs with approved drugs Approximately 120,000 patients Lennox-Gastaut syndrome Dra
Slide 33: Bexicaserin in phase III backed by strong clinical data
Bexicaserin in phase III backed by strong clinical data A differentiated, highly selective 5-HT2C agonist with a compelling efficacy and safety profile Pre-clinical evidence • Reduced seizure, epileptiform activity, duration and number of epileptiform events in fish and rodent models Phase I – Healt
Slide 34: Differentiated by design
Differentiated by design Bexicaserin harbors best-in-class treatment potential across the DEE indication space Indication Cannabidiol1 Fenfluramine4 Bexicaserin5 Potential patient benefit Efficacy better than cannabidiol and similar to fenfluramine Additional benefits Dravet syndrome2 Compelling saf
Slide 35: Promising efficacy across multiple DEE sub-populations
Promising efficacy across multiple DEE sub-populations Phase II study showed best-in-class potential Bexicaserin1 reduced median countable motor seizures Clinical evidence from DEE sub-populations Median percent change from baseline Reduction in median countable motor seizures in full data set (n=52
Slide 36: Sustainable effects shown in open-label extension study
Sustainable effects shown in open-label extension study More than 50% reduction across treatment groups Median percent reduction in monthly seizure frequency from PACIFIC baseline 9-month open-label extension (OLE) Transition to OLE 0 -20 Bexicaserin PACIFIC to bexicaserin OLE Placebo PACIFIC to bex
Slide 37: Currently no approved treatment for MSA
Currently no approved treatment for MSA A rapidly progressing and fatal disease The clinical course Common symptom • Slowness of movement, tremor, or stiffness • Clumsiness or lack of coordination • Croaky, quivering voice • Fainting or light-headedness • Bladder control problems Premotor MSA Possib
Slide 38: Potential first disease-modifying therapy in MSA
Potential first disease-modifying therapy in MSA Amlenetug (Lu AF82422) – Innovative program within rare disease progression towards phase III Progressing towards phase III Market potential Potential first-in-class antibody with superior • AMULET phase II showed 27% slowing of technical profile whic
Slide 39: Inhibiting the spread to other cells
Inhibiting the spread to other cells LuAF82422 potential first disease-modifying therapy in MSA Released α-syn aggregates 1 are bound by Lu AF82422 Lu AF82422 Neuron Lu AF82422 increases α-syn • Lu AF82422 is a human IgG1 mAb that 2 clearance by microglia recognizes and binds to all major forms of e
Slide 40: Potential first-in-class neurohormonal asset
Potential first-in-class neurohormonal asset Anti-ACTH (Lu AG13909) – Strong mechanistic read-outs predict promising future Proof-of- Proof-of- Two pivotal mechanism concept read-outs programs Market potential CAH CAH & CD CAH & CD Potential first-in-human/first-in-class antibody with favorable safe
Slide 41: Letting the molecule speak – CD40L blocker (Lu AG22515)
Letting the molecule speak – CD40L blocker (Lu AG22515) Tapping into well-described and clinically validated biology Targeting the CD40-CD40L interaction Neuroimmunology is a rapidly • Potentially involved in multiple CNS disorders expanding field • Clinically validated biology targeting innate and
Slide 42: Continuous receptor stimulation
Continuous receptor stimulation Lu AF28996 offers continuous D1 and D2 receptor stimulation Mechanism An innovative pro-drug Lu AF28996 Metabolites Continuous exposure achieved with low and sustained by back-and-forth conversion of metabolites serving as a reservoir exposure • Lu AF28996 offers very
Slide 43: Addressing major unmet need in PD
Addressing major unmet need in PD Lack of dopaminergic neurons lead to motor symptoms Parkinson’s disease Targeting the basal ganglia • Parkinson’s disease (PD) is characterized by a progressive loss of dopaminergic neurons Progressive loss of dopaminergic basal ganglia neurons • Under normal condi
Slide 44: An innovative and oral prodrug
An innovative and oral prodrug Lu AF28996 provides a new solution for patients and specialists Broad-acting dopamine D1/D2 receptor agonist providing Lu AF28996 continuous dopaminergic activation • Active metabolite with agonistic properties towards both dopamine D1 and D2 receptors leading to activ
Slide 45: Revenue overview 9M 2024
Revenue overview 9M 2024 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 9M 2024, DKKm 9M 2024, DKKm 18,000 18,000 +13% +13% 16,000 16,000 14,000 14,000 12,000 12,000 10,000 10,000 +21% +14% 8,000 8,000 6,000 6,000 +9% +16% -7% +12% +14% 4,000 +23% 4,000
Slide 46: Revenue overview Q3 2024
Revenue overview Q3 2024 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 Q3 2024, DKKm Q3 2024, DKKm 6,000 +18% 6,000 +18% 4,000 4,000 +25% +19% 2,000 2,000 +27% +16% +12% +22% -5% +19% +24% + 13% +74% +21% 0 0 Total United States Europe International Tot
Slide 47: Product distribution of revenue & YoY growth
Product distribution of revenue & YoY growth Growth % of total % of total Q3 DKKm 9M 2024 9M 2023 Growth (CER) Q3 2024 Q3 2023 Growth (CER) Growth (DKK) (DKK) 9M 2024 2024 Rexulti® 3,806 3,309 16% 15% 23% 1,425 1,174 22% 21% 25% Brintellix®/Trintellix® 3,576 3,207 14% 12% 22% 1,225 1,051 19% 17% 21%
Slide 48: Strategic brands
Strategic brands 9M reported revenue Quarterly reported revenue Comments DKKm DKKm +25% CER Continued strong performance across the 13,500 +21% CER 4,500 strategic brands reaching DKK 12.1bn in 9M 2024 and DKK 4.3bn in Q3 2024 , 12,000 representing a growth of 21% (+20% DKK) 10,500 and 25% (+25% DKK
Slide 49: Rexulti
Rexulti 9M reported revenue Quarterly reported revenue Comments DKKm DKKm +16% CER • Grew by 16% (+15% DKK) and reached +22% CER DKK 3.8bn in 9M 2024 4,000 1,600 3,500 1,400 • Grew by 22% (+21% DKK) and reached DKK 1.4bn in Q3 2024 3,000 1,200 2,500 1,000 • Continued demand growth in the U.S. and ot
Slide 50: Brintellix/Trintellix
Brintellix/Trintellix 9M reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 14% (+12% DKK) and reached +14% CER DKK 3.6bn in 9M 2024 4.000 1.400 +19% CER 3.500 1.200 • Grew by 19% (+17% DKK) and reached DKK 1.2bn in Q3 2024 3.000 1.000 • Strong performance in most markets 2.500
Slide 51: Abilify LAI franchise
Abilify LAI franchise 9M reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 10% (+10% DKK) and reached +10% CER +13% CER DKK 2.6bn in 9M 2024 3.000 1.000 • Grew by 13% (+13% DKK) and reached 2.500 800 DKK 0.9bn in Q3 2024 2.000 • In April 2023, Abilify Asimtufii got FDA 600 app
Slide 52: Vyepti
Vyepti 9M reported revenue Quarterly reported revenue Comments DKKm DKKm +74% CER • Grew by 76% (+76% DKK) and reached 2.500 +76% CER 800 DKK 2.1bn in 9M 2024 700 • Grew by 74% (+74% DKK) and reached 2.000 DKK 0.8bn in Q3 2024 600 • Vyepti franchise protected for several 1.500 500 years: 400 • Paten
Slide 53: Cipralex / Lexapro
Cipralex / Lexapro 9M reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 2% (-4% DKK) and reached DKK 2.000 800 1.6bn in 9M 2024 +2% CER +7% CER • Grew by 7% (+2% DKK) and reached DKK 0.5bn in Q3 2024 1.500 600 • The biggest markets are China, Brazil, Italy, South Korea and Sau
Slide 54: Other pharmaceuticals
Other pharmaceuticals1 9M reported revenue Quarterly reported revenue Comments DKKm DKKm • Down by 13% (-15% DKK) and reached 3.500 1,600 DKK 2.5bn in 9M 2024 -13% CER • Down by 11% (-12% DKK) and reached 3.000 DKK 0.8bn in Q3 2024 2.500 1,200 • Around 15 mature products included -11% CER 2.000 • Bi
Slide 55: Other revenue
Other revenue 9M reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 48% (+49% DKK) and reached DKK 0.3bn in 9M 2024 500 150 +113% CER • Grew by 113% (+113% DKK) and reached DKK 0.1bn in Q3 2024 +48% CER 100 • Mostly contract manufacturing to third- party 250 50 0 0 9M 2021 9M 2
Slide 56: 9M 2024: EBIT & Adjusted EBITDA
9M 2024: EBIT & Adjusted EBITDA DKKm 9M 2024 9M 2023 Change (CER)1 Change (DKK) Revenue 16,463 14,934 13% 10% Gross profit 13,304 11,657 17% 14% thereof adjustments (2) 327 101% 101% thereof depreciation/amortization 1,261 1,359 (7%) (7%) Sales and distribution costs 5,746 5,297 10% 8% thereof adjus
Slide 57: Q3 2024: EBIT & Adjusted EBITDA
Q3 2024: EBIT & Adjusted EBITDA DKKm Q3 2024 Q3 2023 Change (CER)1 Change (DKK) Revenue 5,722 4,952 18% 16% Gross profit 4,628 3,854 23% 20% thereof adjustments - 67 - - thereof depreciation/amortization 420 447 (6%) (6%) Sales and distribution costs 1,952 1,796 10% 9% thereof adjustments 8 - - - th
Slide 58: Full year figures: EBIT & Adjusted EBITDA
Full year figures: EBIT & Adjusted EBITDA DKKm FY 2023 FY 2022 FY 2021 ∆ FY 2023 (CER)1 ∆ FY 2023 (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% Sales and distribution
Slide 59: 2024: Overall Adjusted EBITDA reconciliation
2024: Overall Adjusted EBITDA reconciliation DKKm 9M 2024 Q1 2024 Q2 2024 Q3 2024 Profit from operations (EBIT) 3,093 1,278 1,004 811 Amortization of product rights 1,093 368 363 362 Depreciation and amortization 309 100 104 105 EBITDA 4,495 1,746 1,471 1,278 Restructuring expenses 4 - (2) 6 Other a
Slide 60: FY 2023: Overall Adjusted EBITDA reconciliation
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 1,385 744 Restructuring e
Slide 61: Full year figures: Revenue & Adjusted EBITDA at CER
Full year figures: Revenue & Adjusted EBITDA at CER DKKm 9M 2024 FY 2023 Total revenue (IFRS) 16,463 19,912 Effects from hedging (43) 137 Total revenue (IFRS) before hedging 16,506 19,775 Effects from exchange rate (283) (645) Total revenue at CER 16,789 20,420 Increase/(Decrease) in Total revenue 1
Slide 62: Full year figures: Revenue & Adjusted EBITDA at CER
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/(Decrease) in Total revenue
Slide 63: Less volatility in key currencies in 9M 2024
Less volatility in key currencies in 9M 2024 Sales by currency Main currencies2 Comments FY 2023 December 29, 2022 = index 100 • ~83% of sales in non-EUR currencies 105 • USD directly represents ~52% of sales CAD FY 2023 CNY 100 5% 6% • Three main currencies make up ~61% of 95 net exposure EUR 90 17
Slide 64: Lundbeck is well-positioned through its strong balance sheet
Lundbeck is well-positioned through its strong balance sheet Assets Liabilities Comments DKKbn DKKbn • Inventories driven by Vyepti and Xenazine 39.5 39.5 • Intangible assets decrease driven mainly 37.4 37.4 by product rights amortization Inventories Current liabilities Receivables • ROIC improved f
Slide 65: Financial position and dividend
Financial position and dividend Financial position Dividend, DKK DKKm • Proposed dividend pay-out of DKK 0.70 per share has 30.09.2024 31.12.2023 been paid out for 2023, corresponding to a pay-out ratio of ~30% Intangible assets 18,929 20,692 • A total of DKK 697 million and a yield of 2.1%1 Other n
Slide 66: 9M 2024: Cash generation
9M 2024: Cash generation DKKm 9M 2024 9M 2023 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 4,480 3,139 4,080 3,519 2,272 Cash flows from investing activities (346) (362) (498) (1,892) (610) Cash flows from operating and 4,134 2,777 3,582 1,627 1,662 investing activities (free cash fl
Slide 67: Q3 2024: Cash generation
Q3 2024: Cash generation DKKm Q3 2024 Q3 2023 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 2,302 1,490 4,080 3,519 2,272 Cash flows from investing activities (101) (97) (498) (1,892) (610) Cash flows from operating and 2,201 1,393 3,582 1,627 1,662 investing activities (free cash flo
Slide 68: Strong cash flow leading to continuous deleveraging
Strong cash flow leading to continuous deleveraging Net cash, Net debt and Net debt/EBITDA Solid financial foundation DKKm from which to execute Net cash/(net debt) Net debt/EBITDA on our strategy 8,000 2.0 6,635 • 9M 2024: Cash flow negatively 6,000 1.5 impacted by 3.982 4,000 1.0 • Dividend amount
Slide 69: For more information, please contact Investor Relations
For more information, please contact Investor Relations Listed on the Copenhagen Number of A-shares 199,148,222 Stock Exchange since Number of B-shares 796,592,888 June 18, 1999 Total 995,741,110 IR contacts Treasury A shares 466,028 Palle Holm Olesen For additional company information, Vice Preside
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