Focused innovation driving sustainable growth
The 43rd Annual J.P. Morgan Healthcare Conference - January 13, 2025
Martha
Living with depression and ADHD
Creating value in growing neuroscience market
Well-positioned to secure future success
Neuroscience market growth 8% CAGR expected 2022-20281
Neuroscience in top 3 for new
drug approvals U.S. and EU2
Rapidly evolving science and technologies fuel innovation
Multiple new drug modalities expanding treatment opportunities
Our Focused Innovator strategy
Growth
Secure mid-term growth
Innovation
Lead with focused innovation
Funding
Deliver sustainable Innovation
Disciplined capital allocation
-
Evaluate Pharma, CAGR forecast 2022-2028 (only captures CNS); (2) Nature Reviews Drug Discovery, 2023.
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Leveraging our neuroscience knowledge and competences
Eight out of nine pipeline programs are in neuro-specialty and neuro-rare
Our three selected strategic focus areas
Grow | Expand | Build |
our psychiatry | neuro-specialty | neuro-rare |
core | position | franchise |
Focused innovation
Aiming for
4 assets
in phase III in 2026
Well-positioned
to launch
>2 impactful products from the pipeline
by 2029
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Delivering on our Focused Innovator strategy
Building pipeline for sustainable long-term growth
Growth
Innovation
Funding
Strong operational momentum | Targeted commercial focus |
Strategic brands +21% in 9M 2024 | Successful launch of Rexulti AADAD in the U.S. |
Vyepti +76%, Brintellix/Trintellix +14%, Rexulti +16% | Exceptional Vyepti growth in key markets |
Scale neuro-specialty position | Build neuro-rare franchise |
Vyepti geographic expansion (positive phase III SUNRISE HLR) | Bexicaserin phase III initiated in DEEs |
Anti-PACAP phase IIb initiated in migraine prevention | Amlenetug phase III initiated in MSA |
Anti-ACTH phase Ib initiated in CD and CAH |
Disciplined capital reallocation of DKK +1bn by 2027
Bexicaserin deal enabled by strong cashflow
Mid-term R&D corridor 20-25% Adj. EBITDA >30%
Focused global commercial models
All growth rates at CER; AADAD: Agitation Associated with Dementia in Alzheimer's Disease; PTSD: Post-Traumatic Stress Disorder; E&IO: Europe & International Operations; HLR: Headline results; PACAP: Pituitary Adenylate Cyclase-Activating Peptide;
DEEs: Developmental and Epileptic Encephalopathies; MSA: Multiple System Atrophy; ACTH: Adrenocorticotropic Hormone; CD: Cushing's Disease; CAH: Congenital Adrenal Hyperplasia. Vyepti (eptinezumab-jjmr), Brintellix/Trintellix (vortioxetine), and Rexulti (brexpiprazole). Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and Cushing's Disease. For technical reasons, the latter has been officially categorized as a Phase II trial to adhere to local requirements in Georgia. Bexicaserin, Amlenetug, Anti-PACAP, and Anti-ACTH are investigational compounds that have not been assessed nor approved by the US FDA. Brexpiprazole is not approved by the U.S. FDA for treatment of Post-Traumatic Stress Disorder.
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Strong growth driven by four strategic brands | Growth |
Innovation | |
Ambition to be leader in neuroscience underpinned by 75% revenue contribution of strategic brands | Funding |
Current commercial value drivers1
DKK 3.8bn | DKK 2.1bn |
+16% | +76% |
DKK 3.6bn | DKK 2.6bn |
+14% | +10% |
Mid-term strategic growth ambition
Rexulti | Mid-teen-digit CAGR into 2027 |
with potential upside from PTSD2 | |
Vyepti | Expect to triple sales by end 2027 |
Abilify LAI | Abilify 2-month treatment2 partially |
offsets generic erosion for | |
franchise | |
Abilify Maintena vials | |
Brintellix / | Mid-single-digit CAGR until 2027 in Europe, |
Trintellix | expected LOE impact in Canada, U.S. |
- 9M 2024 sales. All growth rates at CER. (2) Pending FDA approval. Brexpiprazole is not approved by the US FDA for treatment of Post-Traumatic Stress Disorder. (2) Abilify Asimtufii in the U.S., Abilify Maintena 960mg in EU & International Operations. PTSD: Post-Traumatic Stress Disorder; LAI: Long-Acting Injectable.
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Leveraging Vyepti and Rexulti growth opportunities | Growth |
Innovation | |
New geographical areas and indications provide potential for additional commercial expansion | Funding |
SUNRISE study supports significant | Successful AADAD launch drives | |
potential in Asia following approval | increased sales momentum across U.S. market | |
• Exceptional strong uptake of Vyepti in the U.S. | • | Strengthened overall product profile |
• Forms the backbone of our neuro-specialty franchise | • | PTSD sNDA: FDA to host an Advisory Committee, expected H1 2025 |
Vyepti vials volume uptake since launch1
4-week average Number of vials
2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
Total TRx
140.000
120.000
100.000
80.000
60.000
40.000
20.000
0
Rexulti monthly claims volume by indication2
30.000 | ||||
24.000 | ||||
+425% growth | 18.000 | TRx | ||
AADAD | ||||
since FDA approval | ||||
12.000 | ||||
Total TRx (left-hand scale) | 6.000 | |||
AADAD TRx (right-hand scale) | ||||
0 | ||||
Apr-23 | Oct-23 | Apr-24 | Oct-24 |
- Wholesale data, the latest month available is December 20, 2024. (2) IQVIA source of business indication level data in the U.S. through month ending October 2024. AADAD market share in the antipsychotic market. Brexpiprazole is not approved by the U.S. FDA for treatment of Post-Traumatic Stress Disorder. Usage of Rexulti for AADAD prior to FDA-approval was not promoted by Lundbeck or Otsuka.
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Focused Innovator built on disciplined R&D investments | Growth |
Innovation | |
Strong competencies and new technologies combined with focused progression of innovative programs | Funding |
Where we play
Grow
our psychiatry core
Expand neuro-specialty position
Build
neuro-rare franchise
How we play | |||
Let the | Let the | Let the | |
biology | molecule | patient | |
speak | speak | speak | |
Unmet | |||
needs | R&D organization | ||
(executional excellence) |
Breakthrough pipeline potential
through rigorous development process
One organization | Early de-risking from | Fast late development |
focusing on | an adequate number of | guided by patients for |
promising biology | phase I programs | impactful labels |
Innovative | Bringing promising | |
discovery research | projects quickly forward | |
Biotherapeutics, CLiPPr, | to early clinical PoC | |
BBB shuttle etc. |
Transformative
treatments
- Blood Brain Barrier; CLiPPr: Click Probe Profiling.
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Transformed pipeline accelerating long-term growth | Growth |
Innovation | |
Strong momentum with focus on new target biologies and drug modalities | Funding |
Phase I | Phase II | |
2020 onwards | 2023-2024 | |
Rebuilding momentum | +2 | Two first-in-class |
through innovative early | proof-of-concepts | |
development programs … | achieved |
Amlenetug
Anti-PACAP
… with a high bar for progression
Phase III
2026
Aiming
+4 for four assets in phase III
Amlenetug
Anti-PACAP
Anti-ACTH
Bexicaserin
Innovative trial designs targeting indications with high unmet medical needs
PACAP: Pituitary Adenylate Cyclase-Activating Peptide; ACTH: Adrenocorticotropic Hormone. Bexicaserin, Amlenetug, Anti-PACAP, and Anti-ACTH are investigational compounds not available on the market and they have not been assessed nor approved by the U.S. FDA.
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Bexicaserin - A scientifically de-risked asset in phase III | Growth |
Innovation | |
A late-stage asset in attractive neuro-rare space supporting long-term sustainable growth ambitions | Funding |
Bexicaserin
Mode of action
Selective 5-HT2C agonist
Indication
DEEs
Clinical phase
Phase III initiated Q4 2024
Backed by phase II clinical data
- Broad potential across DEEs
- Differentiated molecule with validated mode of action
- Encouraging efficacy and tolerability profile
- Low drug-drug interaction potential
USD ~1.5-2bn
Estimated peak sales1
Expected launch Q4 2028
A comprehensiveIncludeglobale.gphase. III program in DEEs
Phase 3 design
• Evaluate the efficacy, safety and tolerability of bexicaserin Derisking
in DEEs as assessed by countable motor seizures Do not include OLE…
- Participants from 2 years of age and older
- Around 100 sites including U.S., Europe, Australia and Japan
Study 301: DEEs, incl. LGS (n=320)2
Study 302: Dravet syndrome (n=160)3
Study 303: 52-week open-label extension
- Global peak sales potential across Developmental and Epileptic Encephalopathies (DEEs) by LoE in 2040 assuming broad label. Estimated by Lundbeck. (2) NCT06719141. (3) NCT06660394. Bexicaserin is an investigational compound not available on the market and has not been assessed nor approved by the U.S. FDA.
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H. Lundbeck A/S published this content on January 14, 2025, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on January 14, 2025 at 09:19:08.823.