H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — H Lundbeck A/S B — Q1 2025 Earnings Presentation
66 slides from H. Lundbeck A/s Class A's earnings presentation, May 14, 2025
Slide 1: Business update & financial results Q1 2025
Business update & financial Martha, results living with depression Q1 2025
Slide 2: Safe Harbor/Forward-Looking Statements
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 i
Slide 3: 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 Operations R&D Update Johan Luthman Executive Vice President Head
Slide 4: Strong start to the year
Strong start to the year Advancing on our Focused Innovator Strategy Strong start to the year Strategic brands Total revenue +16% Vyepti +62% Growth Strategic brands +24% Rexulti +28% Scale neuro-specialty position Build neuro-rare franchise Innovation Anti-PACAP phase IIb progressing to Part B IV B
Slide 5: 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 5 Q1 2025 – 14 May 2025
Slide 6: Continuation of consistent growth in Q1 2025
Continuation of consistent growth in Q1 2025 U.S. TRx growth of 22% in Q1 2025 versus prior year Global reported revenue DKKm Consistent growth observed +28% CER across all prioritized markets +29% CER DKK 1,491m • Rexulti U.S. TRx weekly market share reached all- DKK 1,375m time high (2.49%1) • U.S
Slide 7: Growth driven by increased penetration in AADAD
Growth driven by increased penetration in AADAD Strong adoption in both community and long-term care channel Monthly claims volume by indication AADAD now makes up ~21% AADAD Launch – May 2023 of total brand performance 28,000 140,000 U.S.: 24,000 120,000 • January Claims Data shows growth across bo
Slide 8: Continued exceptional growth
Continued exceptional growth Growth supported by broad adoption in key priority markets Global reported revenue Vyepti demand in the U.S. DKKm Vials volume uptake since launch1 Continued full investment in the +62% CER brand is driving growth +60% CER Vyepti was the fastest growing aCGRP (March DKK
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 DKKm Strong momentum in Europe +7% CER and International Operations DKK 1,254m • Europe up 17% CER driven primarily by Spain DKK 1,168m (+29%), Portugal (+26
Slide 10: Solid performance contributed by all markets
Solid performance contributed by all markets Abilify LAI franchise continues to grow due to increasing conversions to Abilify 2-month formulation Global reported revenue DKKm Strong growth across most +16% CER markets DKK 1,014m U.S.: • In the U.S., the Abilify LAI franchise market DKK 859m share ha
Slide 11: Penetration of 2-month formulation is ramping up
Penetration of 2-month formulation is ramping up Conversion rate accelerating and exceeds benchmarks Conversion status (U.S) Conversion status (E&IO) Strong focus on accelerating % (Monthly) % (Monthly) conversion rates 15 15 U.S.: • Abilify Asimtufii monthly TRx volume has grown 83% from March 2024
Slide 12: R&D update and outlook
R&D update and outlook Johan Luthman, Executive Vice President, Head of R&D 12 Q1 2025 – 14 May 2025
Slide 13: Recent pipeline events
Recent pipeline events Projects progresses as planned Bexicaserin • Phase III program: DEEp SEA1 (DS patients) and DEEp OCEAN2 (LSG/DEE patients) enrolling patients with sites active in the U.S., and first countries in Europe Amlenetug • Fast Track Designation (MSA) granted by FDA 11 February 2025 •
Slide 14: Vyepti showed robust sustained efficacy in severe migraine
Vyepti showed robust sustained efficacy in severe migraine As add-on to patient education in patients with chronic migraine and medication overuse headache Reduction in monthly migraine days (MMDs) (Mean change from baseline) RESOLUTION 0 Placebo-controlled trial Open-label extension Placebo-control
Slide 15: IV administration of Lu AG09222 (Anti-PACAP)
IV administration of Lu AG09222 (Anti-PACAP) Phase IIb adaptive trial to identify the right dose and route of administration (SC or IV) HOPE PROCEED • HOPE trial participants received IV high • Interim analysis of the SC Part A late March 2025 or low dose of Lu AG09222 or placebo • Randomisation of
Slide 16: Building asset value for Lu AG09222 (Anti-PACAP)
Building asset value for Lu AG09222 (Anti-PACAP) A significant opportunity to address unmet need with a differentiated mode of action Differentiated biology Differentiated effects Potential to broaden compared to CGRP compared to CGRP migraine therapy • PACAP and its receptors are Compared to CGRP,
Slide 17: Building a robust, focused, and de-risked pipeline
Building a robust, focused, and de-risked pipeline A substantial transformation PROJECT BIOLOGY AREA PHASE I PHASE II PHASE III FILING / LAUNCH Eptinezumab (anti-CGRP mAb)1 Migraine prevention2 Hormonal / Lu AG09222 (anti-PACAP mAb)3 Migraine prevention neuropeptide signaling Lu AG13909 (anti-ACTH m
Slide 18: Financial results and outlook
Financial results and outlook Joerg Hornstein, Chief Financial Officer 18 Q1 2025 – 14 May 2025
Slide 19: Strong growth of strategic brands (+24% CER)
Strong growth of strategic brands (+24% CER) Continued robust growth momentum driven by strategic brands constituting 77% of sales Comments Key figures • Revenue: continued strong performance across all DKKm strategic brands and reached an all-time high total revenue in a quarter Q1 2025 Q1 2024 Cha
Slide 20: 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 strong revenue growth, with Q1 2025 Q1 2024 Change (DKK) cost leverage and lower amortization of product rights partially offset by increased R&D linked to EB
Slide 21: Net cash position impacted by Longboard acquisition
Net cash position impacted by Longboard acquisition Strong operating cash flow supports fast deleveraging Cash flow Comments DKKm • Cash inflow from operating activities: cash Q1 2025 Q1 2024 flow from operations in line with EBIT EBIT 1,698 1,278 performance, changes in other operating activities m
Slide 22: FY2025 financial guidance raised
FY2025 financial guidance raised Strong business momentum and disciplined capital allocation New Revenue: +8 – 11% growth (CER) Guidance Adjusted EBITDA: +8% – 14% growth (CER) Revenue Adj. EBITDA Q2 2025 Q2 2025 Continued growth momentum for strategic brands, mainly Investments in R&D driven by pro
Slide 23: Conclusion
Conclusion Charl van Zyl, President & Chief Executive Officer 23 Q1 2025 – 14 May 2025
Slide 24: Strong business momentum
Strong business momentum Steady progress in our Focused Innovator Strategy Growth Innovation Funding • Strong momentum for • Phase III programs with • FY 2025 financial guidance Vyepti in the quarter amlenetug and bexicaserin raised advancing according to plan • Q1 sales growth provides • Revenue Gr
Slide 25: Q&A
Q&A 25 Q12025-14 May 2025, K
Slide 26: Appendix
Appendix 26 Q1 2025 – 14 May 2025
Slide 27: Investments in future growth build on strong financial foundation
Investments in future growth build on strong financial foundation Other relevant financial information 2024 result 2025 soft guidance Total revenue (IFRS) growth1 11% Equal to CER Adjusted EBITDA growth1 12% Around 0.5% points lower than at CER Adjusted gross margin2 88.4% 88% to 89% R&D costs DKK 4
Slide 28: 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 29: 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 30: Anti-PACAP - a new approach to migraine treatment
Anti-PACAP - 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
Slide 31: 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 32: 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 33: 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 34: 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 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: Bexicaserin - differentiated by design
Bexicaserin - 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
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: Lu AF82422 - inhibiting the spread to other cells
Lu AF82422 - inhibiting the spread to other cells Lu AF82422 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 ma
Slide 40: Lu AG13909 - potential first-in-class neurohormonal asset
Lu AG13909 - 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 f
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: Lu AF28996 - continuous receptor stimulation
Lu AF28996 - 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 AF2899
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: Lu AF28996 - an innovative and oral prodrug
Lu AF28996 - 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 lea
Slide 45: Revenue overview Q1 2025
Revenue overview Q1 2025 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 Q1 2025, DKKm Q1 2025, DKKm 8,000 8,000 +16% +16% 6,000 6,000 4,000 +24% 4,000 +25% 2,000 +16% +4% 2,000 +28% -2% +29% +7% +62% +16% +12% +21% 0 0 Total United States Europe Internat
Slide 46: Product distribution of revenue & YoY growth
Product distribution of revenue & YoY growth DKKm Q1 2025 Q1 2024 Growth (CER) Growth (DKK) % of total Q1 2025 Rexulti® 1,491 1,115 28% 34% 24% Brintellix®/Trintellix® 1,254 1,168 7% 7% 20% Vyepti® 1,042 617 62% 69% 17% Abilify LAI franchise 1,014 859 16% 18% 16% Strategic brands 4,801 3,759 24% 28%
Slide 47: Strategic brands
Strategic brands FY reported revenue Quarterly reported revenue Comments DKKm +21% CER DKKm Continued strong performance across the 16,500 6,000 strategic brands reaching DKK 6.2bn in Q1 15,000 +24% CER 2025, representing a growth of 24% (+28% DKK) 13,500 4,500 12,000 Q1 2025 10,500 • +29% (+36% DKK
Slide 48: Rexulti
Rexulti FY reported revenue Quarterly reported revenue Comments DKKm DKKm +16% CER • Grew by 28% (+34% DKK) and reached +17% CER DKK 1.5bn in Q1 2025 5,500 1,600 5,000 • In the U.S., revenue continues to benefit 1,400 4,500 from a strong performance in both 1,200 4,000 AADAD and MDD segments 3,500 1
Slide 49: Brintellix/Trintellix
Brintellix/Trintellix FY reported revenue Quarterly reported revenue Comments DKKm DKKm +14% CER • Grew by 7% (+7% DKK) and reached DKK 5,000 +7% CER 1.3bn in Q1 2025 1.400 4,500 • Strong performance in most markets 1.200 4,000 such as Spain, Canada, Italy and Japan 3,500 1.000 • Japan market share
Slide 50: Abilify LAI franchise
Abilify LAI franchise FY reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 16% (+18% DKK) and reached 4,000 +10% CER 1.200 DKK 1.0bn in Q1 2025 +16% CER 3,500 • In April 2023, Abilify Asimtufii got FDA 1.000 approval 3,000 800 • In March 2024, Abilify Maintena 960 mg 2,500 (ar
Slide 51: Vyepti
Vyepti FY reported revenue Quarterly reported revenue Comments DKKm DKKm +72% CER • Grew by 62% (+69% DKK) and reached +62% CER 3,000 1,100 DKK 1bn in Q1 2025 1,000 • U.S. market share reached 10.0% in 2,500 900 March, supported by record-high 800 demand and strong sequential 2,000 momentum througho
Slide 52: Cipralex / Lexapro
Cipralex / Lexapro FY reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 1% (1% DKK) and reached DKK 2.500 800 0.6bn in Q1 2025 +2% CER +1% CER • The largest markets are China, Saudi 2.000 Arabia, Brazil and South Korea in Q1 600 2025 1.500 • The patent expired in 2012 (U.S.) a
Slide 53: Other pharmaceuticals
Other pharmaceuticals1 FY reported revenue Quarterly reported revenue Comments DKKm DKKm • Down by 4% (-2% DKK) and reached DKK 4.500 1.200 0.8bn in Q1 2025 4.000 -9% CER • Around 15 mature products included -4% CER 3.500 • Biggest products are Azilect, Cipramil, 3.000 Cisordinol, Deanxit, Ebixa, Fl
Slide 54: Other revenue
Other revenue FY reported revenue Quarterly reported revenue Comments DKKm DKKm • Down by 29% (-29% DKK) and reached 500 150 DKK 50m in Q1 2025 -29% CER +12% CER • Mostly contract manufacturing to third- party 100 250 50 0 0 FY 2021 FY 2022 FY 2023 FY 2024 Q1.22 Q1.23 Q1.24 Q1.25 Total Total Unless
Slide 55: Q1 2025: EBIT & Adjusted EBITDA
Q1 2025: EBIT & Adjusted EBITDA DKKm Q1 2025 Q1 2024 Change (CER)1 Change (DKK) Revenue 6,235 5,288 16% 18% Gross profit 5,151 4,279 19% 20% thereof depreciation/amortization 395 421 (8%) (6%) Sales and distribution costs 1,872 1,789 2% 5% thereof adjustments (2) - - - thereof depreciation/amortizat
Slide 56: FY 2024: EBIT & Adjusted EBITDA
FY 2024: EBIT & Adjusted EBITDA DKKm FY 2024 FY 2023 Change (CER)1 Change (DKK) Revenue 22,004 19,912 14% 11% Gross profit 17,774 15,427 19% 15% thereof adjustments (2) 327 101% 101% thereof depreciation/amortization 1,681 1,826 (8%) (8%) Sales and distribution costs 8,146 7,482 10% 9% thereof adjus
Slide 57: Q1 2025 and FY 2024: Overall Adjusted EBITDA reconciliation
Q1 2025 and FY 2024: Overall Adjusted EBITDA reconciliation DKKm Q1 2025 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Profit from operations (EBIT) 1,698 1,278 1,004 811 177 Amortization of product rights 336 368 363 362 339 Depreciation and amortization 110 100 104 105 135 EBITDA 2,144 1,746 1,471 1,278 651 Res
Slide 58: FY 2024: Overall Adjusted EBITDA reconciliation
FY 2024: Overall Adjusted EBITDA reconciliation DKKm FY 2024 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Profit from operations (EBIT) 3,270 1,278 1,004 811 177 Amortization of product rights 1,432 368 363 362 339 Depreciation and amortization 444 100 104 105 135 EBITDA 5,146 1,746 1,471 1,278 651 Restructuring
Slide 59: YTD and FY figures: Revenue & Adjusted EBITDA at CER
YTD and FY figures: Revenue & Adjusted EBITDA at CER DKKm Q1 2025 FY 2024 Total revenue (IFRS) 6,235 22,004 Effects from hedging (71) (52) Total revenue (IFRS) before hedging 6,306 22,056 Effects from exchange rate 143 (344) Total revenue at CER 6,163 22,452 Increase/(Decrease) in Total revenue 18%
Slide 60: Increased volatility in key currencies from H2 2024
Increased volatility in key currencies from H2 2024 Sales by currency Main currencies2 Comments Q1 2025 December 29, 2023 = index 100 • ~83% of sales in non-EUR currencies 110 • USD directly represents ~54% of sales in CAD Q1 2025 CNY 105 5% 6% • Three main currencies make up ~60% of 100 net exposur
Slide 61: 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 57.0 57.0 • Intangible assets decrease driven mainly Inventories 54.2 54.2 Current liabilities by the lower amortization of product Receivables rights as w
Slide 62: Financial position and dividend
Financial position and dividend Financial position Dividend, DKK DKKm • Proposed dividend pay-out of DKK 0.95 per share for 31.03.2025 31.12.2024 2024, corresponding to a pay-out ratio of ~30% Intangible assets 38,557 40,167 • A total of DKK 946 million and a yield of 2.3%1 Other non-current assets
Slide 63: Q1 2025: Cash generation
Q1 2025: Cash generation DKKm Q1 2025 Q1 2024 Cash flows from operating activities 632 961 Cash flows from investing activities (111) (94) Cash flows from operating and investing activities (free cash flow) 521 867 Cash flows from financing activities (2,480) (760) Net cash flow for the period (1,95
Slide 64: FY 2024: Cash generation
FY 2024: Cash generation DKKm FY 2024 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 3,326 4,080 3,519 2,272 Cash flows from investing activities (15,286) (498) (1,892) (610) Cash flows from operating and (11,960) 3,582 1,627 1,662 investing activities (free cash flow) Cash flows from
Slide 65: 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 127,465 Jens Høyer For additional company information, Vice President, Hea
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