H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — Lundbeck — Investor Day (October 2024)
71 slides from H. Lundbeck A/s Class A's investor day presentation, Oct 23, 2024
Slide 1: Focused innovation driving sustainable growth
Focused innovation driving sustainable growth Lundbeck Capital Markets Event – October 23, 2024 Martha Living with depression and ADHD
Slide 2: Agenda for today
Agenda 12.00 - 12.30 Registration with light lunch for today 12.30 -15.00 Presentations including Q&A with Executive Management • Charl van Zyl, Chief Executive Officer • Maria Alfaiate, EVP, Commercial & Corporate Strategy • Tom Gibbs, EVP, Lundbeck U.S. • Michala Fischer-Hansen, EVP, Europe & Inte
Slide 3: 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 4: Important Information for Investors and Security Holders
IMPORTANT INFORMATION FOR INVESTORS AND SECURITY HOLDERS The tender offer (the Offer) for the outstanding common stock of Longboard referred to in this presentation has not yet commenced. The description contained in this presentation is neither an offer to purchase nor a solicitation of an offer to
Slide 5: Driving sustainable long-term growth
Driving sustainable long-term growth Our Focused Innovator strategy Secure mid-term growth Growth Focus on growth potential of key strategic brands to offset mid-term loss of exclusivities Lead with focused innovation Innovation Building a pipeline as the engine to fuel sustainable growth Deliver su
Slide 6: Creating the foundation for a promising future
Creating the foundation for a promising future Strong progress during last year Strategic brands Rexulti Vyepti Brintellix/Trintellix Secure mid-term H1 2024 growth H1 2024 growth of 13% YoY AADAD H1 2024 growth of 78% YoY H1 2024 growth of 19% YoY approved in the U.S. Patient-focused operating mode
Slide 7: Transformed pipeline accelerating towards 2026 and beyond
Transformed pipeline accelerating towards 2026 and beyond New target biologies, drug modalities, and de-risking in early development Phase I Phase II Phase III 2020 onwards 2023-2024 2026 Rebuilding momentum Two first-in-class Aiming through innovative early development programs … +2 proof-of-concep
Slide 8: Uniquely positioned for compelling market opportunities
Uniquely positioned for compelling market opportunities Pursuing our goal to serve patients Guided by strong outcomes Supported by biomarkers Rigorous in early development development process Let the molecule speak Breakthrough innovation Partnering with patients and doctors Early de-risking Let the
Slide 9: Transforming to a focused innovator
Transforming to a focused innovator Combining internal and external innovation to fuel sustainable long-term growth 2024 - 2026 2027 - 2029 2030 - 2033 Focus Scale Accelerate Grow strategic brands Migraine & neuro-rare franchise Organic pipeline breakthroughs • Rexulti U.S., Vyepti U.S. and E&IO • A
Slide 10: Highly experienced international executive team
Highly experienced international executive team Seasoned leadership with proven success in growth strategies and value creation Thomas Gibbs Executive Vice President, Lundbeck US Charl van Zyl President and CEO Complementary skillsets foster innovation Dianne Hol Executive Vice President, Maria Alfa
Slide 11: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 12: Our focus and how we win
Our focus and how we win Maria Alfaiate, Executive Vice President, Commercial & Corporate Strategy Thomas Gibbs, Executive Vice President, Lundbeck US Michala Fischer-Hansen, Executive Vice President, Europe & International Operations Johan Luthman, Executive Vice President, Research & Development 1
Slide 13: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introduction from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP, L
Slide 14: Innovation and patient focus to accelerate U.S. growth
Innovation and patient focus to accelerate U.S. growth Thomas Gibbs, Executive Vice President, Lundbeck U.S. 14 Capital Markets Event – October 23, 2024
Slide 15: Differentiated commercial capabilities
Differentiated commercial capabilities Driving patient-centric, innovative model to accelerate our growth Externally focused Internally focused Patient focus Leadership behaviors Enhance patient support ecosystem Embed curiosity, adaptability, to overcome barriers Lundbeck U.S. and accountability gr
Slide 16: Precision execution of our Focused Innovator strategy
Precision execution of our Focused Innovator strategy U.S. has the potential to build multiple USD +1bn franchises in the next decade Our U.S. long-term ambition What we’ve accomplished Deliver USD +1.3bn in annual Rexulti sales Our strategic choices by loss of exclusivity1 Grew Rexulti sales by 18%
Slide 17: Focus on key strategic markets
Focus on key strategic markets Michala Fischer-Hansen, Executive Vice President, Europe & International Operations 17 Capital Markets Event – October 23, 2024
Slide 18: Transforming to become a focused innovator
Transforming to become a focused innovator Building on our strategic brands Around 2,500 employees >50 markets1 + partners Building on a DKK ~10bn in revenue strong foundation Strong growth of Brintellix ~50% of total revenue1 and Abilify Maintena Vyepti rolled out in 29 markets Key brands and growi
Slide 19: Allocating investments towards key growth markets
Allocating investments towards key growth markets A new operating model that enables reaching as many patients as possible while driving capital allocation to key growth opportunities Total revenue Strategic Neuro-rare/ Share of total brand specialty Our key markets share readiness 81% USA Germany A
Slide 20: R&D throughout the value chain
R&D throughout the value chain Johan Luthman, Executive Vice President, Research & Development 20 Capital Markets Event – October 23, 2024
Slide 21: Neuroscience at the forefront of scientific breakthroughs
Neuroscience at the forefront of scientific breakthroughs Rapid technological, medical, and regulatory advances are driving innovation of new treatments, but more are needed Migraine – New efficacious class Technological advances are • CGRP targeting treatments for prevention of migraine R&D tour ex
Slide 22: Focused Innovator built on rigorous R&D processes
Focused Innovator built on rigorous R&D processes Combining our strong competencies and new technologies with disciplined selection and progression in innovative programs Where we play Build upon our psychiatry core Reinforce Breakthrough pipeline potential neuro-specialty position through rigorous
Slide 23: Reallocating resources to support innovation and growth
Reallocating resources to support innovation and growth Focused R&D efforts in strategic brands to fund future pipeline development From broad R&D efforts … to focused R&D support to strategic brands on strategic brands … and expanding innovation pipeline Building migraine franchise Amlenetug Enters
Slide 24: Meeting patients' needs in different markets
Meeting patients' needs in different markets Key takeaways: Optimizing our operating model for success Innovation and patient focus to accelerate U.S. growth Commercial model and market approach in Europe & International Operations to maximize value of key markets R&D capital allocation that best le
Slide 25: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 26: Advancements in the field of AADAD
Advancements in the field of AADAD Important further insights into Rexulti in AADAD1 Sustained effect on CMAI2 for 24 weeks of treatment Most bothersome agitation behaviors Proportion of patients with a clinical meaningful response (At least 20 points change in CMAI score) identified by caregivers3
Slide 27: Brexpiprazole consistently reduced PTSD symptoms
Brexpiprazole consistently reduced PTSD symptoms Clinical data shows improved effects in combination treatment with sertraline PTSD symptoms reduced at week 10 LS mean (SE) change from week 1 measured in CAPS-5 total score (pooled from three trials)1 0 Increasing efficacy in PTSD management • Pooled
Slide 28: Strong growth in AADAD propelling Rexulti demand
Strong growth in AADAD propelling Rexulti demand Significant opportunity exists to drive future brand growth AADAD now contributes 17.5% of demand … significant unmet need exists for and ~22% of NBRx for Rexulti … diagnosis and treatment of AADAD +15% growth 24.000 since FDA approval 110.000 6.7 mil
Slide 29: Current indications U.S. delivering blockbuster potential
Current indications U.S. delivering blockbuster potential New indication offers additional upside if approved Current Further opportunity indications pending approval ~2.2m drug-treated patients ~15m PTSD1 drug-treated patients ~1.6m MDD drug-treated patients AADAD ~1.1m drug-treated patients SCZ La
Slide 30: Driving continued Brintellix/Trintellix growth
Driving continued Brintellix/Trintellix growth Continues strong momentum, especially in Europe and Japan Revenue DKKbn EU & International Operations Revenue H1 2024 DKK 2.4bn (+11% CER) United States EU & International Operations 4.3 4.3 +14.7% • Continued double-digit growth in most markets 3.5 • J
Slide 31: Growth continues for Abilify LAI franchise
Growth continues for Abilify LAI franchise Creating value with strategic focus on key markets Revenue Lundbeck’s share, DKKbn Revenue H1 2024 DKK 1.7bn (+9% CER) EU & International Operations United States EU & International Operations • LAI market share above 30% in more than half of the markets 3.
Slide 32: Accelerating growth with key markets focus
Accelerating growth with key markets focus Key takeaways: Build upon our psychiatry core Accelerating Rexulti performance in the U.S. (specifically AADAD) as a driver to counter mid-term LoEs Growth of Trintellix/Brintellix in Europe & International Operations reinforcing our leading position in psy
Slide 33: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 34: Vyepti is setting new industry growth records
Vyepti is setting new industry growth records Growth is outpacing the highest medical benefit industry analogs Growth % Year-over-year The next Vyepti wave 140% Vyepti has built a growing base of 120% prescribers with strong clinical conviction 100% Vyepti and the orals continue a growth trend while
Slide 35: We are building a patient-centric model for Vyepti
We are building a patient-centric model for Vyepti Delivering impact today while building scalability for the future A patient-focused ecosystem Impact delivered over the last 12 months Activate HCPs and Improve access Conversion patients to drive demand perceptions to expand ~65% Patients who start
Slide 36: Blockbuster status potentially earlier than initially indicated
Blockbuster status potentially earlier than initially indicated EU & International Operations represents a significant upcoming growth driver Revenue DKKbn United States Revenue H1 2024 EU & International Operations DKK 1.2bn (+68% CER) in the U.S. DKK 0.2bn (+206% CER) in EU & International Operati
Slide 37: Data strengthening the clinical profile of Vyepti
Data strengthening the clinical profile of Vyepti Moving into new frontiers Sustainable effect1 Reduction in “brain fog”1 Expansion in Asia Sustained reductions in headache 86% of patients with brain fog Adapting design frequency and severity reported improvement in symptoms on learnings (Mean frequ
Slide 38: Addressing unmet needs beyond Vyepti
Addressing unmet needs beyond Vyepti Untapped market potential remains 40 to 70% of people with migraine do not have a sufficient benefit from Migraine market potential CGRP-targeted medications1 Significant unmet needs remain in chronic migraine treatment Remaining unmet needs in migraine Assets in
Slide 39: Unlocking new potential in migraine treatment
Unlocking new potential in migraine treatment Anti-PACAP (Lu AG09222) phase IIb study progressing to evaluate subcutaneous efficacy Anti-PACAP holds the potential for broad symptomatic effects Potential first pivotal Anti-PACAP phase IIb PROCEED trial dose "Anti-PACAP significantly Phase III Double-
Slide 40: Building a migraine franchise
Building a migraine franchise Key takeaways: Reinforce neuro-specialty position Growing strength in neuro-specialty with Vyepti as base Fueling growth with U.S. patient-centric operating model and Europe & International Operations focus on key markets Addressing high unmet needs in migraine anti-PAC
Slide 41: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 42: Strategic acquisitions complement internal innovation
Strategic acquisitions complement internal innovation Integrating leading technologies, biology understanding and drug candidates through external outreach Successful R&D Combining internal resources and external Bolstering our neuro-rare innovation to create a strong pipeline 70% franchise • Intern
Slide 43: 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 44: 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 45: 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 46: 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 47: 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 48: 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 49: 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 50: 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 51: 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 52: R&D engine creating an innovative and compelling pipeline
R&D engine creating an innovative and compelling pipeline Key takeaways: Establish neuro-rare franchise Building neuro-rare franchise combining internal and external innovation including amlenetug and bexicaserin1 Large unmet need potential supported by scientific breakthroughs Lundbeck R&D competen
Slide 53: Focused innovation driving sustainable growth
Focused innovation driving sustainable growth Creating a compelling pipeline with best/first-in-class assets Build upon Reinforce Establish our psychiatry core neuro-specialty position neuro-rare franchise Continued growth of Vyepti achieves Rexulti in the U.S. and Amlenetug and blockbuster status B
Slide 54: Q&A
Q&A Hosted by Charl van Zyl, President & Chief Executive Officer 54 Capital Markets Event – October 23, 2024
Slide 55: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 56: Creating value through strategic capital allocation
Creating value through strategic capital allocation Joerg Hornstein, Chief Financial Officer 56 Capital Markets Event – October 23, 2024
Slide 57: Growing and improving profitability
Growing and improving profitability Disciplined focus to optimally leverage existing resources In DKKm FY 2022 FY 2023 H1 2024 Revenue 18,246 19,912 10,741 • Accelerating revenue growth vs. LY (in CER1) 8% 8% 8% 10% post-COVID on the back of strategic brands Strategic brands 12,135 13,733 7,799 • Vy
Slide 58: Strategic brands to drive continuous growth into 2027
Strategic brands to drive continuous growth into 2027 Expecting mid-single-digit CAGR into 2027 with significant upside from Rexulti in PTSD if approved1 Revenue ambition Illustrative Mid-single-digit CAGR Mid-teen-digit CAGR into 2027 Rexulti with potential upside from PTSD1 High single-digit CAGR
Slide 59: Continued growth from in-market assets to organic pipeline
Continued growth from in-market assets to organic pipeline Building on strong mid-term momentum to secure future long-term growth Additional growth from early-stage pipeline Revenue ambition and potential business development activities Illustrative More than DKK 30bn 20 - Abilify Maintena + Vyepti
Slide 60: Allocating resources to ensure sustainable growth
Allocating resources to ensure sustainable growth How do we fund our growth ambitions? Organic uses of capital Organic sources of capital Excess resources Acceleration of Options in focus Continuous growth of Vyepti strategic brands Exploiting full potential Business development of Rexulti Longboard
Slide 61: Largest capital reallocation program in Lundbeck's history
Largest capital reallocation program in Lundbeck’s history Improving margins while funding our future Illustrative Inflow / increase in capital Outflow / decrease in capital 2023 base Capital reallocation program 2027 organic Organic sources of capital Organic uses of capital Acceleration of strateg
Slide 62: Largest capital reallocation program in Lundbeck's history
Largest capital reallocation program in Lundbeck’s history Improving margins while funding our future Illustrative Inflow / increase in capital Outflow / decrease in capital 2023 base Capital reallocation program 2027 organic Longboard3 2027 target Organic sources of capital Organic uses of capital
Slide 63: Allocating excess resources to drive shareholder value
Allocating excess resources to drive shareholder value Available opportunities Pecking order Objective Organic business Profitable and sustainable growth Resilient balance sheet Maintain an investment grade rating at all times Dividend 30% - 60% of net profit for the year Fair competition principles
Slide 64: Mid-term guidance backed by clarity on strategic drivers
Mid-term guidance backed by clarity on strategic drivers Profitable and sustainable organic growth Key drivers Mid-term guidance 2027 Total revenue growth (%) Expect to triple sales by 2027 Mid-teen-digit CAGR until 2027 driven by strong patient-focused excl. potential upside from PTSD ecosystem Mid
Slide 65: Capital allocation enabling sustainable long-term growth
Capital allocation enabling sustainable long-term growth Building from a strong financial foundation and strategic brands growth in the mid-term Mid-term guidance for 2027 aligned with Focused Innovator strategy and backed by clarity on strategic drivers and contributors Lundbeck initiates most sign
Slide 66: Agenda
Agenda Focused innovation driving sustainable growth Charl van Zyl Chief Executive Officer Our focus and how we win Optimizing our operating model for success Maria Alfaiate Introductions from Tom, Michala, and Johan EVP, Commercial & Corporate Strategy Tom Gibbs Build upon our psychiatry core EVP,
Slide 67: 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 Pivotal Amlenetug (anti-α-
Slide 68: Lundbeck playing to win
Lundbeck playing to win Building on a solid foundation to create a promising future High degree of visibility Strong growth for Vyepti Rexulti PTSD provides into the growth momentum and Rexulti set to continue upside if approved Secure long-term growth Lead with Focused Several best/first-in-class B
Slide 69: Q&A
Q&A Hosted by Charl van Zyl, President & Chief Executive Officer 69 Capital Markets Event – October 23, 2024
Slide 70: Thank you!
Thank you! Next on agenda for guests attending in person: R&D tour with KOL talk on MSA 70 Capital Markets Event – October 23, 2024
Slide 71: List of abbreviations
List of abbreviations AADAD: Agitation Associated with Dementia in Alzheimer’s Disease LGS: Lennox-Gastaut Syndrome ACTH: Adrenocorticotropic Hormone LS: Least Squares ALS: Amyotrophic Lateral Sclerosis MAGLi: Monoacylglycerol lipase inhibitor ASO: Antisense Oligonucleotides MDD: Major Depressive Di