Driving Sustainable Profitable Growth
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Driving Sustainable
Profitable Growth
COPENHAGEN, JANUARY 2021
Lundbeck1
COMPANY DISCLAIMER
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.
Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially from
expectations and it may cause any or all of our forward-looking statements
here or in other publications to be wrong. Factors that may affect future results
include interest rate and currency exchange rate fluctuations, delay or failure
of development projects, production problems, unexpected contract breaches
or terminations, government-mandated or market-driven price decreases for
Lundbeck's products, introduction of competing products, Lundbeck's ability to
successfully market both new and existing products, exposure to product
liability and other lawsuits, changes in reimbursement rules and governmental
laws and related interpretation thereof, and unexpected growth in costs and
expenses.
Lundbeck undertakes no duty to update forward-looking statements.
Certain assumptions made by Lundbeck are required by Danish Securities
Law for full disclosure of material corporate information. Some assumptions,
including assumptions relating to sales associated with products that are
prescribed for unapproved uses, are made taking into account past
performances of other similar drugs for similar disease states or past
performance of the same drug in other regions where the products are
currently marketed. It is important to note that although physicians may, as
part of their freedom to practice medicine in the U.S., prescribe approved
drugs for any use they deem appropriate, including unapproved uses, at
Lundbeck, promotion of unapproved uses is strictly prohibited.
Lundbeck
INTRODUCTION
Lundbeck: A focus on delivering current and future growth
Maximizing current growth drivers Rexulti: Substantial future growth drivers
• Driving growth through our core brands • Interim analysis (phase III) in Alzheimer’s
and new innovative brands agitation due Q2 2021
• Phase III study in PTSD ongoing
Vyepti: Global roll-out offers substantial Solid potential in pipeline
growth opportunities • Broad LCM activity for Vyepti and Rexulti
• Submitted in 9 markets, approved in two • Maturing early-stage portfolio of
• Phase III in episodic cluster headache innovative medicines
Good growth visibility the next 6-8 years Financial strength
• Northera LOE (Feb. 2021) behind us • Solid balance sheet and strong cash
• Current product portfolio grows strongly generation
• Resilient mature base business • Relentless focus on efficiency
3 Lundbeck
INTRODUCTION
Lundbeck has a clear ambition to continue delivering on a
heritage of growth
Lundbeck revenue 1999 – 2020e
(FY - DKKm) Lundbeck has delivered average revenue
growth of more than 7% p.a. the past two
decades
Short periods of impacts from LOEs have been
navigated through growth from both internal and
external innovations
Lundbeck has emerged much stronger post
LOE periods
2000 2005 2010 2015 2020
4 Lundbeck
INTRODUCTION
Our strategy is a multi-year journey to ensure Lundbeck
is best placed to restore brain health for decades to come…
❑ Migraine franchise in the making
• Vyepti launched in the U.S.
MAXIMIZE
EXISTING
EXPAND
OPERATING
• Indication and geographic expansion for Vyepti initiated
BRANDS SPACE
❑ Strong growth across strategic brands
❑ Global footprint with growth in all regions of the world
Expand ❑ Optimizing the R&D-organization
and Invest • Built experimental medicine
• Focus internal discovery on four biological clusters
MAINTAIN
FOCUS ON
to Grow REBUILD
PROFITABILITY PIPELINE ❑ Lundbeck Seattle BioPharmaceuticals builds antibody capabilities
• Second clinical candidate, PACAP, in phase I and a third in pre-clinic
ENHANCE
ORGANI-
❑ Lundbeck La Jolla Research Center created
ZATIONAL • Two clinical candidates in development
AGILITY AND
COLLABO-
• Establishing a strong platform for innovation
RATION
❑ Maintain solid profitability while investing in future growth
❑ Solid, stable cash generative mature brands
5 Lundbeck
INTRODUCTION
Diverse portfolio across products and regions with growth
across all regions
Lundbeck product mix Lundbeck geographic split* Regional growth
Sales by product (9M 2020) Sales by region (9M 2020) (9M 2020 – DKKm and in %)
13%
19% +6%
North America
Abilify Maintena
Brintellix/Trintellix
41% Northera 17% North America
Rexulti International Markets
Vyepti Europe Int. Markets +8%
Rest 56%
25%
14%
0% Europe +4%
15%
Strategic brands:
59% 0 150 300 450
*Revenue by Region excluding Other revenue and hedging effects.
6 Lundbeck
PRODUCT PERFORMANCE
Solid financial performance driven by strategic brand portfolio
- impact from Onfi LOE in 2019
Strategic brands’ sales Revenue and core EBIT
(9M - DKKm) (9M - DKKm)
2.400
13.921
13.397
12.842 12.615
2.000
11.469
10.861
10.221
1.600 Strategic brands
CAGR: +80%
1.200
5.227
800
Abilify Maintena 3.946 4.010 3.714
Brintellix/Trintellix
2.463
400 Northera
Rexulti
1.466
774
Vyepti
0
9M.14 9M.15 9M.16 9M.17 9M.18 9M.19 9M.20 9M.14 9M.15 9M.16 9M.17 9M.18 9M.19 9M.20
Revenue Core EBIT
7 Lundbeck
PRODUCT PERFORMANCE
Trintellix and Rexulti show signs of recovering to pre-COVID-19
levels
Trintellix demand (U.S.)* Rexulti demand (U.S.)*
(weekly - NRx) (weekly - NRx)
28.000 12.000
27.000 11.500
26.000 11.000
25.000 10.500
24.000 10.000
23.000 9.500
22.000 9.000
21.000 8.500
20.000 8.000
0 0
Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1
20 20 20 20 21 20 20 20 20 21
• NRx negatively impacted by reduced promotional activity • NRx negatively impacted by reduced promotional activity
and patient access to HCPs due to COVID-19 and patient access to HCPs due to COVID-19
• Stable market share in the U.S. of around 0.9% (volume)** • Stable market share in the U.S. of around 2% (volume)**
• Increased market share seen in other markets in both • Increased market share seen in other key markets –
Europe and Asia** recently launched in Brazil and Italy**
Source: *) Symphony Health (ref. Bloomberg), Weekly data view through 18 December 2020 and **) IQVIA
8 Lundbeck
PRODUCT PERFORMANCE
Vyepti doubles sales compared to previous quarter
• Sales reached DKK 42 million Vyepti demand
for 9M 2020 following launch in (weekly - vials)
April
• Q4 vial demand doubles
compared to Q3
• J-code effective from 1 October
• >130m lives covered without
branded step-edit
• Very positive testimonials from
both patients and HCPs
Apr. May Jun. Jul. Aug. Sep. Oct. Nov. Dec.
Vyept was approved by FDA in February 2020 Weekly data view through 18 December 2020
9 Lundbeck
PRODUCT PERFORMANCE
Vyepti global roll-out brings significant growth potential
• On 22 December, the European Medicines Agency
(EMA) accepted Lundbeck's application for marketing
Prevalent cases of migraine
authorization of Vyepti
Region Migraine
• Expected approval by EU Commission early 2022 prevalence
• Currently submitted for approval in nine markets* USA 63m
Canada 6m
• Recently approved in United Arab Emirates
• Approval in Canada is expected during Q1 2021
Europe 135m
• Development activities in other regions and countries
around the world, including China and Japan, are in
planning Japan 18m
China 133m
• The market for prophylactic migraine treatments in value
is expected to grow considerably in the coming years
Brazil 33m
Source: The Lancet Neurology; Vol 17,
November 2018
*) During 2020, Lundbeck has submitted an application for market authorization of
Vyepti in several markets, including Australia, Brazil, Canada, EU, Indonesia, Kuwait,
the Philippines, Singapore, Switzerland and United Arab Emirates.
10 LundbeckRESEARCH & DEVELOPMENT
Vyepti: Phase III study for treatment of cluster headache, a
crippling pain with few effective medication currently available
Cluster headache affects approximately one in 1,000 ALLEVIATE phase III study to evaluate Vyepti in
people across the world episodic Cluster Headache (eCH)
• Vyepti intravenous in ~300 patients with eCH
These are severe attacks of one-sided pain in the head
• Primary endpoint: Change from baseline in
Cluster headaches are also known as, "Suicide number of weekly attacks (Weeks 1–2)
Headaches," as suicide attempts by patients that
experience this are 20x higher than average • The target population is defined as patients with
eCH, based on the IHS ICHD-3 classification*
Duration 15-180 min • Study commenced in December 2020
Frequency 1-8 times a day
Age of onset 20-40 yrs • Trial completion expected H2 2023
Prevalence 1:1,000
Episodic/chronic ratio 6:1
Male/female ratio 4.3:1
*) The International Classification of Headache Disorders 3rd edition
11 LundbeckRESEARCH & DEVELOPMENT
Interim Analysis for effect in the study using Rexulti in agitation
in Alzheimer’s disease (AAD) planned for Q2 2021
Unmet medical need Fast Track designation granted February 2016
Total U.S. societal costs of dementia are estimated to be
USD 277 billion* Status of third pivotal study:
• Third study with an adaptive design*** moving ahead under FDA
>20% of individuals in a community setting agreement
>50% of nursing home residents with dementia have • Exposure to 2 and 3 mg/day
agitation
• Recruitment and conduct of the trial impacted by the COVID-19
Agitation may be an important predictor of institutionalization pandemic
• Decision to increase the power of the trial and adjust the sample
Rexulti and AAD size and conduct an interim analysis, when a targeted sample of
Second generation antipsychotics have shown efficacy in ~255 subjects has completed the trial
AAD, but not approved due to tolerability/ safety profile
• Interim Analysis for efficacy - due Q2 2021
Rexulti capitalizes on balanced and tried MoA (efficacy) and
better safety profile • Total sample size raised to 330 patients – exp. completion ~H1
2022
Two pivotal studies concluded in May 2017**
*) The Alzheimer’s Association 2018 Alzheimer’s Disease Facts and Figures report. **) Grossberg et al. The American Journal of Geriatric Psychiatry; October 2019 . ***) NCT03548584
12 LundbeckRESEARCH & DEVELOPMENT
During 2020 in R&D, we crafted the future innovation strategy
for our internal discovery research…
Our goal is to build the premier neuroscience pipeline with a dynamic and
adaptable innovation approach to meet patients’ needs
Strengthened decision making A global, balanced and flexible
Focus on prioritized biological
platforms allowing for a wide matrix organization matching our
Strong translational data at all pipeline activities at any time
disease area reach and
stage gates from Research
innovative solutions
through Development to Market
13 LundbeckRESEARCH & DEVELOPMENT
Focus research in four biology clusters where the science has
the most potential to deliver innovative therapies…
Circuitry / neuronal Protein aggregation,
biology folding and clearance
Targeting neurotransmission /
synaptic dysfunction to restore Targeting neurodegenerative
brain circuits ”proteinopathies”
Neuroinflammation /
Hormonal /
neuroimmunology
neuropeptide signalling
Targeting brain function through
Targeting selected pathways of
the innate and adaptive immune
pain signals and stress response
system
Enables a wide disease area reach and innovative solutions across our target indication space
14 LundbeckFINANCE
Strong operational performance in 2020 despite COVID-19
9M 2020 sales growth in line with pre-COVID-19 expectations
• Solid growth for all strategic brands 2020 FY financial guidance
• Mature brands very resilient
• Negative currency impact in H2 2020
Good core EBIT margin of 27.7%
Sales growth:
• Strong focus on operational efficiencies 3 – 4.5%
• SG&A savings from COVID-19 of DKK ~600-700 million
Strong balance sheet Core EBIT margin:
• Net debt: DKK 5,006mn (USD ~800mn)
24.1% – 25.7%
• Net debt/EBITDA: 1.1x*
*) 9M 2020, rolling four quarters
15 LundbeckFINANCE
Cash flow priorities: Dividend pay-out will be linked to long-term
performance
Net debt Prioritize external Dividends
innovation
• Net debt around • Increase financial • Pay-out policy:
DKK 5 billion in flexibility 30-60% of net
2020 • EUR 500m bond profit
• Maintain programme
established
investment grade
status – i.e.
NIBD/EBITDACORPORATE STRATEGY
Progress made on our ‘Expand and Invest to Grow’ journey has
informed our future indication focus…
Lundbeck’s historical indication focus Lundbeck’s future indication focus
Specialist and broad indications Specialist indications addressing high unmet need
Substantial commercial footprint including PCP More focused commercial footprint preferably not
coverage in some markets requiring PCP coverage
Challenging development programmes Tractable development programmes
Sustainable pricing with potential for
Pricing pressure in some portfolio areas
‘innovator’ premium
Preference for products with focused commercial footprints that do not require commercial partnerships
Future
partnership We may enter into regional partnerships to gain access to innovative, growth products
strategy
We may enter partnerships for innovative and differentiated internal assets that require meaningful PCP coverage
17 LundbeckCORPORATE STRATEGY
Our future medicines will provide a step-change in outcomes
to patients with difficult to treat brain diseases…
Future focus
2020
Four biological clusters, Refined operating space:
enabling wide disease area Targeted indications
reach and innovation
Indication groups
2019 Niche neurology
Expanded disease Rare disease neurology
operating space
Niche psychiatry
Psychiatry
Neurology
Business development and/or internal pipeline may provide Lundbeck
Other
access to adjacent, non-neuroscience areas in pursuit of the most
structurally attractive opportunities, as long as they are rooted in
neuroscience
18 LundbeckESG UPDATE
Lundbeck aspires to be a leader in sustainability and with a longstanding
commitment to serve societal needs where we can make a difference
• ESG Strategy referencing SDGs updated to defining our Category 9M 2020 9M 2019 Δ% y/y
aspirations for 2030 including annual target setting
Energy (MWh) * 69,809 68,601 2%
• Established Access to Brain Health strategy centring on CO2 (tonnes) * 11,668 12,149 (4%)
access to brain health care and reduction in stigma
Work related accidents * 4.6 6.5 (29%)
• Renewed Diversity and inclusion policy and action plan No. of employees (FTE) 5,761 5,569 3%
*) This data only covers our headquarters and larger affiliates with research,
• Zero tolerance for discrimination and harassment development and manufacturing activities
of any kind
• Lundbeck is committed to climate action as foundational
to our social contract in the countries we operate
• Listed in the Carbon Disclosure Project “Climate A
List”
• In total, we have achieved CO2 reduction of 68%
since 2006
• In Q3 submitted a new, ambitious climate target
which includes emissions from our entire value
chain to the Science-Based Target initiative (SBTi)
19 LundbeckSUM-UP
Key news flow the next 12-18 months
H1 2021
• Vyepti approval in Canada
• FY 2020 due 4 February
• Planned interim analysis using Rexulti in Alzheimer’s agitation
(phase III) due Q2
H2 2021
• Phase II to commence for Lu AF82422 and Lu AG09222
• Phase II study using Rexulti in Borderline Personality Disorder
H1 2022
• Vyepti approval by the European Commission
• Phase III programme using Rexulti in PTSD
20 LundbeckSUM-UP
Our ambition - To be #1 in Brain Health
Providing transformative outcomes to targeted patient segments
in highly attractive commercial areas
(niche and rare disease neurology + niche psychiatry)
• Recognized as #1 in Brain Health by patients and other
stakeholders globally
• Premier neuroscience pipeline
• Focused commercial footprint around target patient segments
• Best in class use of digital technologies to improve patient
outcomes
• On track to be carbon neutral by 2050
21 LundbeckThank you 22 Lundbeck
9M 2020 - RESEARCH & DEVELOPMENT
R&D pipeline progressing, clinical trials attracting increasing
numbers of patients despite COVID-19
Project Area Phase I Phase II Phase III Filing Comment
Eptinezumab (anti-CGRP mAb) Migraine prevention Submitted in ten markets
Episodic cluster headache Phase III clinical study started Q4 2020
Brexpiprazole1) Agitation in Alzheimer’s disease Interim Analysis planned for Q2 2021
PTSD
Borderline Personality Disorder
Aripiprazole 2-month injectable Schizophrenia+bipolar I disorder Pivotal phase I completed
Lu AF82422 (alpha-synuclein mAb) Synucleinopathies Planned to enter phase II mid-2021
Lu AF28996 (D1/D2 agonist) Parkinson’s disease
Lu AG06466 (MAGLi)2) PTSD Entered phase Ib in September
Neurology/psychiatry 3 additional phase Ib studies to be initiated
in H1 2021
Lu AF88434 (PDE1B inhibitor) Cognitive dysfunction
Lu AG09222 (PACAP mAb)3) Migraine Planned to enter phase II H2 2021
Lu AF87908 (Tau mAb) Tauopathies
Lu AG06479 (MAGLi)2) Neurology/psychiatry
1) Acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
2) MAGLi: Monoacylglycerol lipase inhibitor (“MAGlipase”).
3) PACAP: inhibits pituitary adenylate cyclase-activating polypeptide
23 LundbeckYou can also read
