H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — H Lundbeck A/S B — H1 2024 Earnings Presentation
67 slides from H. Lundbeck A/s Class A's earnings presentation, Aug 21, 2024
Slide 1: Business update and financial results H1 2024
Business update and financial results H1 2024 August 21, 2024
Slide 2: Company disclaimer
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 future events
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 Markets R&D Update Johan Luthman Executive Vice President Head of
Slide 4: Lundbeck's Executive Management team in place
Lundbeck’s Executive Management team in place Charl van Zyl Dianne Hol Johan Luthman President and CEO Executive Vice President, Executive Vice President, People & Organization Research & Development Maria Alfaiate Michala Fischer-Hansen Thomas Gibbs Executive Vice President, Executive Vice Presiden
Slide 5: Several actions taken towards becoming a Focused Innovator
Several actions taken towards becoming a Focused Innovator Undertake comprehensive capital reallocation initiatives Secure stable Lead with Deliver sustainable long-term growth focused innovation profitability • Boosting strategic brands - Investing • U.S. collaboration with Takeda • Confirming 30-3
Slide 6: Strong performance across the business in H1 2024
Strong performance across the business in H1 2024 Confirming strategic intent to deliver mid-term guidance Solid operational Strong growth Achieved key R&D performance of strategic brands pipeline milestones • Revenue: DKK 10.7bn (+10%) • DKK 7.8bn 73% of total revenue • Lu AG22515 (CD40L blocker) i
Slide 7: 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
Slide 8: Continued strong growth during H1 2024 (Vyepti)
Continued strong growth during H1 2024 Growth supported by robust adoption in key prioritized markets Global reported revenue Vyepti demand in the U.S. Full investment behind the DKKm Vials volume uptake since launch brand continues to drive +78% CER growth DKK 1,342m +68% CER Brand performance DKK
Slide 9: Rexulti delivers strong performance in Q2 2024
Rexulti delivers strong performance in Q2 2024 U.S. TRx growth of 17% in Q2 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 +13% CER +265% growth since FDA approval penetration in AADAD +11%
Slide 10: AADAD volume constitutes 14% of demand and 22% of NBRx
AADAD volume constitutes 14% of demand and 22% of NBRx Rexulti monthly claims volume by indication Rexulti TRx growth AADAD Launch – May 2024 observed across the brand 20,000 120,000 Brand performance 100,000 • AADAD contribution has grown from 5% 16,000 to 14% (May 2024) 80,000 • Rexulti monthly no
Slide 11: Consistent double-digit growth across key markets
Consistent double-digit growth across key markets Strong performance in Europe and International Markets Global reported revenue Growth in key markets Strong momentum DKKm MAT Volume growth in Europe and International +11% CER Markets DKK 2,351m Australia 2% 14% Brand performance DKK 2,156m Canada 0
Slide 12: 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 Delivering double-digit DKKm MAT volume growth growth driven by strong +9% CER performance Australia 4% DKK 1.725m 10% Brand
Slide 13: R&D update
R&D update Johan Luthman, Executive Vice President, Head of R&D
Slide 14: The R&D pipeline progress continues
The R&D pipeline progress continues Key regulatory activities and major events Brexpiprazole • FDA filing of sNDA for PTSD accepted; FDA PDUFA Action date on February 8, 2025 • Full PTSD data-set presented at ASCP in May 2024 Lu AG13909 (anti-ACTH) • Proof of Concept trial initiated in Cushing’s dis
Slide 15: Important further insights into Rexulti in AADAD
Important further insights into Rexulti in AADAD Scientific presentations at Alzheimer's Association International Conference (AAIC), July 2024 Sustained effect on CMAI4 over 24 weeks of treatment based on response Presentations on post hoc pooled analysis rate (20 points change CMAI = clinical mean
Slide 16: Impactful data on the clinical profile of Vyepti
Impactful data on the clinical profile of Vyepti Scientific presentations at American Headache Society (AHS), June 2024 Phase III PREVAIL trial shows that patients with chronic migraine Real-world REVIEW study shows improvements in “brain fog” treated with Vyepti achieved sustained reductions in hea
Slide 17: Lu AG13909 (anti-ACTH): Cushing's Disease PoC trial initiated
Lu AG13909 (anti-ACTH): Cushing’s Disease PoC trial initiated Lundbeck progresses further into neurohormonal dysfunctions with First-in-Class program Symptoms • Lu AG13909 is an IgG1monoclonal antibody binding to ACTH with high affinity aiming to reduce elevated ACTH levels. • Weight gain and increa
Slide 18: Good progress in the pipeline
Good progress in the pipeline News-rich period 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)
Slide 19: Financial results and outlook
Financial results and outlook Joerg Hornstein, Chief Financial Officer
Slide 20: Robust revenue growth
Robust revenue growth Driven by strong growth of strategic brands growing 19% Key figures Comments DKKm • Revenue: Strong performance across all strategic H1 2024 H1 2023 Growth (CER)1 Growth (DKK) brands • Adjusted gross margin: Operating leverage not fully Revenue 10,741 9,982 10% 8% offsetting hi
Slide 21: 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 operating performance H1 2024 H1 2023 Change (DKK) partially offset by higher OPEX • Net financials, income: Positive development in EBIT 2,282 2,073 10%
Slide 22: Lundbeck in a strong net cash position
Lundbeck in a strong net cash position Strong cash flow leading to continuous deleveraging Cash flow Comments DKKm • Cash inflow from operating activities: a H1 2024 H1 2023 combination of higher EBIT, lower inventory build-up and short-term liabilities EBIT 2,282 2,073 • Cash outflow from investing
Slide 23: Raised financial outlook for 2024
Raised financial outlook for 2024 Upgrade driven by higher expectations for Vyepti and Rexulti in the U.S. and Brintellix/Trintellix in Europe and Asia Guidance FY2024 Other relevant financial information Total revenue growth at reported 1 Around 3%-points lower than CER Previous Revised guidance gu
Slide 24: Conclusion
Conclusion Charl van Zyl, President & Chief Executive Officer
Slide 25: Lundbeck becoming a Focused Innovator
Lundbeck becoming a Focused Innovator Accelerating pipeline momentum, disciplined investment to fuel growth Secure stable Lead with Deliver sustainable long-term growth focused innovation profitability • Robust sales growth provides • Continue R&D progression for mid- • Confidence in FY2024 guidance
Slide 26: Q&A
Q&A
Slide 27: Appendix
Appendix
Slide 28: 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 29: 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 30: 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 31: 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 32: 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 33: α-Synuclein aggregation kills cells
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 Targeting α-synuclein (dying from α-syn fibrils) • Alpha-synuclein (α-syn) is a neuronal monomer oligomer fibrils protein inv
Slide 34: 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 35: 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 36: 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 37: 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 38: 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 39: High potential in a range of disorders
High potential in a range of disorders The benefits of CD40L blokage Blocks immune Reduced auto- responses Targeting CD40L antibodies Reduce inflammation • Blocking CD40L inhibits both B- and T-cell activations without direct clearance of B-cell populations Increase • Immunomodulatory instead of reg
Slide 40: A first-in-class neurohormonal asset
A first-in-class neurohormonal asset Early clinical proof of mechanism established Targeting the ACTH axis Hypothalamus • The Hypothalamic Pituitary Adrenal (HPA) axis Pituitary gland governs numerous physiological and pathophysiological functions CRH • Strong and well-established biological link Br
Slide 41: A selective dual modulator
A selective dual modulator MAGLi balances neurotransmission Reduce neuro-inflammation Targeting MAGL 2-Arachidonoylglycerol (2-AG) Restore neuronal transmission • MAGL is an enzyme that controls the level of circulating endocannabinoid MAGL MAGLi 2-AG (Monoacylglycerol lipase) (MAGL inhibitor) • 2-A
Slide 42: Revenue overview H1 2024
Revenue overview H1 2024 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 H1 2024, DKKm H1 2024, DKKm 12,000 12,000 +10% +10% 10,000 10,000 8,000 8,000 6,000 +19% +11% 6,000 4,000 4,000 +8% -8% +10% +13% +11% +20% +9% 2,000 +16% 2,000 +78% +17% 0 0 Total U
Slide 43: Revenue overview Q2 2024
Revenue overview Q2 2024 Reported geographic revenue split & YoY growth1 Reported product revenue split & YoY growth1 Q2 2024, DKKm Q2 2024, DKKm 12,000 12,000 +13% +13% 10,000 10,000 8,000 8,000 +21% 6,000 +14% 6,000 4,000 4,000 +11% +12% -5% +23% +18% +12% 2,000 +18% 2,000 + 8% +16% +78% 0 0 Total
Slide 44: Product distribution of revenue & YoY growth
Product distribution of revenue & YoY growth Growth Growth % of total Growth Growth % of total DKKm H1 2024 H1 2023 Q2 2024 Q2 2023 (CER) (DKK) H1 2024 (CER) (DKK) Q2 2024 Rexulti® 2,381 2,135 13% 12% 22% 1,266 1,075 18% 18% 23% Brintellix®/Trintellix® 2,351 2,156 11% 9% 22% 1,183 1,079 12% 10% 22%
Slide 45: Strategic brands
Strategic brands H1 reported revenue Quarterly reported revenue Comments DKKm DKKm Strong performance across the strategic +21% CER brands reaching DKK 7.8bn in H1 2024 9,000 +19% CER 4,500 and DKK 4.0bn in Q2 2024 , representing 7,500 a growth of 19% (+18% DKK) and 21% (+20% DKK) respectively 6,000
Slide 46: Rexulti
Rexulti H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 13% (+12% DKK) and reached +13% CER 2,500 1,400 +18% CER DKK 2.4bn in H1 2024 1,200 • Grew by 18% (+18% DKK) and reached 2,000 DKK 1.3bn in Q2 2024 1,000 • Demand growth continues in the U.S. 1,500 800 and other regi
Slide 47: Brintellix/Trintellix
Brintellix/Trintellix H1 reported revenue Quarterly reported revenue Comments DKKm DKKm +12% CER • Grew by 11% (+9% DKK) and reached +11% CER 2,500 DKK 2.4bn in H1 2024 1,200 • Grew by 12% (+10% DKK) and reached 1,000 2,000 DKK 1.2bn in Q2 2024 800 • Continued robust demand in most 1,500 markets 600
Slide 48: Abilify LAI franchise
Abilify LAI franchise H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 9% (+9% DKK) and reached DKK 2,000 1,000 1.7bn in H1 2024 +9% CER +8% CER • Grew by 8% (+8% DKK) and reached DKK 800 0.9bn in Q2 2024 1,500 • In April 2023, Abilify Asimtufii got FDA 600 approval 1,000
Slide 49: Vyepti
Vyepti H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 78% (+77% DKK) and reached 1,500 +78% CER 800 +78% CER DKK 1.3bn in H1 2024 700 • Grew by 78% (+79% DKK) and reached DKK 0.7bn in Q2 2024 600 1,000 • Vyepti franchise protected for several 500 years: 400 • Patents iss
Slide 50: Cipralex / Lexapro
Cipralex / Lexapro H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 1% (-7% DKK) and reached DKK 1,500 800 1.1bn in H1 2024 +1% CER • Grew by 1% (-7% DKK) and reached DKK +1% CER 0.5bn in Q2 2024 600 1,000 • The biggest markets are China, Brazil, Italy, South Korea and Sau
Slide 51: Other pharmaceuticals
Other pharmaceuticals1 H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Down by 13% (-26% DKK) and reached 1,600 DKK 1.7bn in H1 2024 2.500 • Down by 8% (-10% DKK) and reached -13% CER DKK 0.9bn in Q2 2024 2.000 1,200 -8% CER • Around 15 mature products included 1.500 • Biggest pr
Slide 52: Other revenue
Other revenue H1 reported revenue Quarterly reported revenue Comments DKKm DKKm • Grew by 20% (+19% DKK) and reached DKK 0.2bn in H1 2024 250 150 +28% CER • Grew by 28% (+26% DKK) and reached DKK 0.1bn in Q2 2024 +20% CER • Mostly contract manufacturing to third- 100 party 50 0 0 H1 2021 H1 2022 H1
Slide 53: H1 2024: EBIT & Adjusted EBITDA
H1 2024: EBIT & Adjusted EBITDA DKKm H1 2024 H1 2023 Change (CER)1 Change (DKK) Revenue 10,741 9,982 10% 8% Gross profit 8,676 7,803 14% 11% thereof adjustments (2) 260 101% 101% thereof depreciation/amortization 841 912 (8%) (8%) Sales and distribution costs 3,794 3,501 10% 8% thereof depreciation/
Slide 54: Q2 2024: EBIT & Adjusted EBITDA
Q2 2024: EBIT & Adjusted EBITDA DKKm Q2 2024 Q2 2023 Change (CER)1 Change (DKK) Revenue 5,453 4,938 13% 10% Gross profit 4,397 3,800 18% 16% thereof adjustments (2) 159 101% 101% thereof depreciation/amortization 420 448 (7%) (6%) Sales and distribution costs 2,005 1,828 11% 10% thereof depreciation
Slide 55: 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 56: 2024: Overall Adjusted EBITDA reconciliation
2024: Overall Adjusted EBITDA reconciliation DKKm H1 2024 Q1 2024 Q2 2024 Profit from operations (EBIT) 2,282 1,278 1,004 Amortization of product rights 731 368 363 Depreciation and amortization 204 100 104 EBITDA 3,217 1,746 1,471 Restructuring expenses (2) - (2) Other adjustments 150 - 150 Adjuste
Slide 57: 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 58: Full year figures: Revenue & Adjusted EBITDA at CER
Full year figures: Revenue & Adjusted EBITDA at CER DKKm H1 2024 FY 2023 Total revenue (IFRS) 10,741 19,912 Effects from hedging (35) 137 Total revenue (IFRS) before hedging 10,776 19,775 Effects from exchange rate (230) (645) Total revenue at CER 11,006 20,420 Increase/(Decrease) in Total revenue 8
Slide 59: 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 60: Sales by currency and main currencies
Lundbeck is well-positioned through its strong balance sheet Sales by currency Main currencies2 Comments FY 2023 29 December 2023 = index 100 • ~83% of sales in non-EUR currencies 105 • USD directly represents ~52% of sales CAD 100 FY 2023 5% CNY 6% 95 • Three main currencies make up ~60% of net exp
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 39.1 39.1 • Intangible assets decrease driven mainly 37.4 37.4 by product rights amortization Inventories Current liabilities Receivables • ROIC improved f
Slide 62: Financial position and dividend
Financial position and dividend Financial position Dividend, DKK DKKm • Proposed dividend pay-out of DKK 0.70 per share has 30.06.2024 31.12.2023 been paid out for 2023, corresponding to a pay-out ratio of ~30% Intangible assets 20,371 20,692 • A total of DKK 697 million and a yield of 2.1%1 Other n
Slide 63: H1 2024: Cash generation
H1 2024: Cash generation DKKm H1 2024 H1 2023 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 2,178 1,649 4,080 3,519 2,272 Cash flows from investing activities (245) (265) (498) (1,892) (610) Cash flows from operating and 1,933 1,384 3,582 1,627 1,662 investing activities (free cash fl
Slide 64: Q2 2024: Cash generation
Q2 2024: Cash generation DKKm Q2 2024 Q2 2023 FY 2023 FY 2022 FY 2021 Cash flows from operating activities 1,271 1,271 4,080 3,519 2,272 Cash flows from investing activities (151) (188) (498) (1,892) (610) Cash flows from operating and 1,066 1,083 3,582 1,627 1,662 investing activities (free cash fl
Slide 65: 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 • H1 2024: Cash flow negatively 6,000 1.5 impacted by 4,000 1.0 • Dividend amounting to
Slide 66: 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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