61 slides from H. Lundbeck A/s Class A's earnings presentation, Feb 6, 2020
Slide 1: Investor presentation FY 2019
Investor presentation FY 2019 COPENHAGEN, 6 FEBRUARY 2020 Lundbeck1
Slide 2: Company disclaimer
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 assu
Slide 3: Lundbeck saw strong progress against Expand and Invest to Grow strategy
HIGHLIGHTS AND STRATEGY UPDATE Lundbeck saw strong progress against Expand and Invest to Grow strategy • Strategic brands grew 28% in 2019 with long-term predictable growth MAXIMIZE EXPAND EXISTING OPERATING • Two acquisitions expand the indications within neuroscience BRANDS SPACE and add to the pi
Slide 4: Lundbeck returned to growth in Q4 2019
HIGHLIGHTS AND STRATEGY UPDATE Lundbeck returned to growth in Q4 2019 Revenue performance Core EBIT performance (DKKm) (DKKm) 20.000 -6% 8.000 -19% 15.000 6.000 10.000 4.000 +5% 5.000 2.000 +4% 0 0 FY 2018 FY 2019 Q4 18 Q4 19 FY 2018 FY 2019 Q4 18 Q4 19 • The reduced impact from Onfi erosion makes L
Slide 5: Double-digit revenue growth in all regions for the four strategic brands
HIGHLIGHTS AND STRATEGY UPDATE Continued excellence in commercial execution delivers double- digit revenue growth in all regions for the four strategic brands 1.000 800 North America +26% North America +25% 800 Europe+Int. Markets Europe+Int. Markets +39% 600 +56% 600 400 400 200 200 0 0 Q4.17 Q4.18
Slide 6: 2019: A transition year - strategic brands mitigate Onfi LoE
HIGHLIGHTS AND STRATEGY UPDATE 2019: A transition year - The strength of our strategic brands significantly mitigates Onfi LoE • Focus on maximizing existing brands has Revenue distribution successfully driven strong growth (FY 2019 - DKKm) • Y/Y revenue decline driven solely by genericization of U.
Slide 7: Eptinezumab: On a path towards launch and global roll-out
HIGHLIGHTS AND STRATEGY UPDATE Eptinezumab: On a path towards launch and global roll-out • November: Lundbeck Seattle Biopharmaceuticals organization in place • November 2019: Initiation of RELIEF study • January 2020: U.S. sales reps hired • U.S. PDUFA: 21 February 2020 • February 2020: Submission
Slide 8: Potential for multiple new launches the next five years
HIGHLIGHTS AND STRATEGY UPDATE Potential for multiple new launches the next five years Project Area Status Eptinezumab Migraine prevention • U.S.: PDUFA on 21 February; Expected launch April 2020 • Filings in Canada, EU and other selected markets in 2020 Brexpiprazole Agitation in Alzheimer’s • Phas
Slide 9: Readying Lundbeck for a new growth phase – 2020 and beyond
HIGHLIGHTS AND STRATEGY UPDATE Readying Lundbeck for a new growth phase – 2020 and beyond • Strategic brands provide strong, predictable long-term growth • Highly efficient global infrastructure • Transformative launch of eptinezumab during 2020 • Expanding pipeline with promising science for future
Slide 10: Significant progress made in expanding and revitalizing the pipeline
RESEARCH & DEVELOPMENT Significant progress made in expanding and revitalizing the pipeline Progression of internal pipeline Brexpiprazole Lu AF11167 Brexpiprazole PTSD Schizophrenia Borderline Personality Disorder (Phase III) (Phase II) (Phase II) MAXIMIZE EXPAND EXISTING OPERATING Lu AF88434 Lu AF
Slide 11: Several late-stage clinical trials initiated in 2019
RESEARCH & DEVELOPMENT Several late-stage clinical trials initiated in 2019 • Brexpiprazole • Two pivotal studies1) initiated in October 2019 in adults with PTSD (n = 733 and 577) • A phase II study3) initiated October 2019 in adults with Borderline Personality Disorder (n = 240) • ANCHOR study4) in
Slide 12: Migraine prevention represents a large and under served market
EPTINEZUMAB Migraine prevention represents a large and under served market Migraine is divided into two major categories, episodic Addressable population and chronic depending on the frequency of headaches (major countries1) ~134m – Migraine prevalence 1-14 headache days >14 headache days per month
Slide 13: Ready to launch eptinezumab in the U.S.
EPTINEZUMAB Ready to launch eptinezumab in the U.S. Migraine prevention market: 13.9m1, 2 Diagnosed, 47% untreated Breakout of 27% treated group Untreated, Preventive Treatment % of Use3 undiagnosed Botox 10% people with migraine Anti-CGRPs 5% Diagnosed & preventively Other preventive treatments (To
Slide 14: Two large pivotal studies demonstrated sustained efficacy and good tolerability
EPTINEZUMAB Two large pivotal studies including ~2,000 patients demonstrated sustained efficacy and good tolerability Promise 1 Promise 2 Powerful ≥50%, ≥75% and in Episodic Migraine Patients in Chronic Migraine Patients 100% reductions in migraine days (N=888) (N=1,072;) • Primary endpoint: Change
Slide 15: PROMISE 1: Phase III study of eptinezumab in episodic migraine
EPTINEZUMAB PROMISE 1: A phase III study to evaluate the efficacy and safety of eptinezumab for prevention of frequent episodic migraine • Eptinezumab reaching statistical significance for the primary and all key secondary endpoints • Migraine day prevalence dropped over 50% on Day 1 and reduction w
Slide 16: Eptinezumab reductions in migraine activity: PROMISE 2 in chronic migraine
EPTINEZUMAB Eptinezumab achieved meaningful reductions in migraine activity as early as Day 1 that were sustained through Week 12: results from PROMISE 2 phase III trial in chronic migraine Day 1 Reductions from baseline in ≥75% Migraine Responder Rates (RR) • In subjects with chronic migraine perce
Slide 17: HIT-6 is a widely used patient-reported outcome measure
EPTINEZUMAB HIT-6 is a widely used patient-reported outcome measure in headache and migraine research • General measure of impact of headache on daily life1 • Six-item scale (severe pain, limits daily activities, lie down, too tired, felt fed up or irritated, limits concentration)1 • Scoring2: • ≥60
Slide 18: RELIEF-study: Starting migraine prevention during attack
RESEARCH & DEVELOPMENT RELIEF-study: Starting migraine prevention during attack • Enrollment commenced in November 2019 (n=450 subjects who are candidates for preventive therapy)* 100 mg eptinezumab vs. placebo • Single-dose study with a 4-week follow-up period • Study to complete by the end of 2020
Slide 19: Success for eptinezumab is a marathon, not a sprint
EPTINEZUMAB Success for eptinezumab is a marathon, not a sprint LOE ~2035 China + Japan Europe ~2025 Selected regions in Int. Markets Eptinezumab PDUFA Date ~2022 Other indications currently 2021 under evaluation; clinical activity RELIEF study – Nov. 2019 to commence by the end of 2020 21 Feb. BLA
Slide 20: Alzheimer's progresses as planned
BREXPIPRAZOLE Third study in brexpiprazole pivotal programme in Agitation in Alzheimer’s progresses as planned Third study out of three in the pivotal programme (phase III): Study objective1 Brexpiprazole (fixed dose 2mg and 3mg) and placebo To compare the efficacy of 2 doses of brexpiprazole with P
Slide 21: Brexpiprazole in pivotal programme for agitation in Alzheimer's disease
BREXPIPRAZOLE Brexpiprazole in pivotal programme for the treatment of agitation in Alzheimer’s disease Agitation in Associated with: Alzheimer’s Alzheimer’s disease Disease (AD) (AAD) 50 million people worldwide have dementia >20% of individuals in a Increased caregiver (Alzheimer’s is the most comm
Slide 22: PTSD offers an exciting opportunity for brexpiprazole
BREXPIPRAZOLE PTSD offers an exciting opportunity for brexpiprazole PTSD epidemiology Post-traumatic Stress Disorder PoC study4 showed… (PTSD) >8m – U.S. prevalence Combination of brexpiprazole and (2.5%-3.6%)1, 2 ~8.6m U.S. adults affected, but sertraline demonstrated ~80% estimated to be undiagnos
Slide 23: Both studies in brexpiprazole pivotal programme in PTSD ongoing
BREXPIPRAZOLE Both studies in brexpiprazole pivotal programme in PTSD ongoing Two studies initiated in the pivotal programme (phase Study objective1 III) To evaluate the efficacy, safety, Brexpiprazole (fixed 2 , 3mg and flexible dose up to 3mg) in and tolerability of 12-week combination with sertra
Slide 24: Borderline Personality Disorder offers an opportunity for brexpiprazole
BREXPIPRAZOLE Borderline Personality Disorder (BPD) offers an exciting opportunity for brexpiprazole BPD epidemiology Borderline Personality Disorder (BPD) ~5m – U.S. prevalence Dysfunctions in the serotoninergic and dopaminergic (1.6%, but likely higher)1) systems is considered as possible causes f
Slide 25: Brexpiprazole PoC study in Borderline Personality Disorder ongoing
BREXPIPRAZOLE Brexpiprazole PoC study in Borderline Personality Disorder (BPD) ongoing Study objective1 Phase II To evaluate the efficacy and Brexpiprazole (flexible dose 2-3mg) and placebo safety of 12-week brexpiprazole for the treatment of subjects Primary endpoint: Zanarini Rating Scale for Bord
Slide 26: Lundbeck La Jolla biology platform exploring serine hydrolases
LU AG06466 Lundbeck La Jolla has access to an exciting biology platform exploring serine hydrolases starting with the endocannabinoid system Access to world class MAG-lipase development candidates to bolster our portfolio Pipeline in a drug – many potential indications Discovery site in U.S. World c
Slide 27: Phase IIa study investigating Lu AG06466 near finalization
LU AG06466 Phase IIa study investigating Lu AG06466 near finalization Study objective1 Phase IIa: This study will assess the safety, Two active arms (10mg and 30mg) + placebo tolerability, and effect on tics Lu AG06466 (previously ABX-1431) N = ~48 patients in adults with Tourette Syndrome or chroni
Slide 28: PDE10 inhibition: a new approach combining D1 and D2 effects
LU AF11167 PDE10 inhibition: A new approach to obtain a combined D1 agonist-like effect and D2 antagonist-like effect D1 Receptor D2 Receptor Stimulator Inhibitor Stimulator Inhibitor R+ AC R- Maintain R+ AC R- Gs Gi Improve Gs Gi ATP control of ATP negative cAMP PDE10 positive cAMP PDE10 AMP sympto
Slide 29: Proof-of-concept study commenced in December 2018
LU AF11167 Proof-of-concept study commenced in December 2018 Monotherapy* Screening 1 Screening 2 Baseline Completion Two fixed-flexible doses, once daily 1-2mg/day Clinically stable patients on antipsychotic 3-4mg/day AF 11167 flex-flexible low dose placebo n = 80 N = ~250 patients AF 11167 flex-fl
Slide 30: Negative symptoms represent a major unmet medical need
LU AF11167 Negative symptoms represent a major unmet medical need Schizophrenia has three core symptoms: Positive, cognitive and negative symptoms Prevalence (major countries) Negative symptoms together with impaired cognition are the major cause of the marked functional disability 4.7m Prevalence o
Slide 31: Pipeline - >50% of current projects are new since February 2019
RESEARCH & DEVELOPMENT Pipeline - >50% of current projects are new since February 2019 Project Area Phase I Phase II Phase III Filing Eptinezumab (anti-CGRP mAb) Migraine prevention Brexpiprazole Agitation in Alzheimer’s disease ~2021 Brexpiprazole PTSD ≥2023 Brexpiprazole Borderline Personality Dis
Slide 32: Commitment to the UN Global Compact Principles and SDGs
ESG – SUSTAINABILITY UPDATE Commitment to the UN Global Compact Principles and to the Sustainable Development Goals (SDG) underpins our business • Contribute to solving societal Overview of our ambitions, initiatives and targets challenges where we can SUSTAINABLE LUNDBECK’S SUSTAINABILITY - 2020 TA
Slide 33: Achieves Climate A List top 2%
ESG – SUSTAINABILITY UPDATE Achieves Climate A List top 2% of more than 8,400 companies evaluated for their actions against climate change Category 2019 2018 Change (%) Energy (MWh) 93,137 94,312 (1.2) CO2 (tonnes) 15,254 15,973 (4.5) Work related accidents with absence (accidents per 1 mill working
Slide 34: Robust financial performance in 2019
FINANCE Robust financial performance in 2019 - Investments in new products and reduced exposure to generic erosion FY2019 Q4.2019 • Revenue impacted by DKKm FY 2019 Δ% y/y Q4 2019 Δ% y/y • Return to revenue growth Onfi erosion Revenue 17,036 (6%) 4,421 +5% • Strategic brands up 28% • Gross margin in
Slide 35: Core P&L shows solid underlying financial performance
FINANCE Core P&L shows solid underlying financial performance • Gross margin fairly stable as DKKm FY % % total Q4 % % total expected 2019 change revenue 2019 change revenue Revenue 17,036 (6%) 100 4,421 +5% 100 • Core EBIT mainly impacted by Gross margin 85.1% -0.3pp - 83.4% -1.2pp - investments in
Slide 36: Four strategic brands added DKK 2.1 billion in additional revenue
FINANCE Lundbeck’s four strategic brands added DKK 2.1 billion in additional revenue in 2019 Strategic brands’ growth (FY 2019 - DKKm) • Strategic brands*: Up 28% (24% in L.C.) to DKK 9,385 million representing 55% of total revenue Brintellix/Trintellix +30% • Brintellix/Trintellix: Up 30% to DKK 2,
Slide 37: Brintellix/Trintellix continues its significant growth momentum
FINANCE Brintellix/Trintellix continues its significant growth momentum • Grew 30% (26% in L.C.) to Brintellix/Trintellix sales per region Brintellix/Trintellix sales DKK 2,826 million in 2019 (Quarterly - DKKm) (FY - DKKm) 1.000 3.200 • Continued solid traction in +30% value share gains1) North Ame
Slide 38: Rexulti shows significant growth driven by demand
FINANCE Rexulti shows significant growth driven by demand - roll-out in new markets continues • Grew 32% (25% in L.C.) to Rexulti sales per region* Rexulti sales* DKK 2,270 million in 2019 (FY - DKKm) (Quarterly - DKKm) • In the U.S., volume is up 19% 800 North America 2.400 +32% y/y in Q41) Other r
Slide 39: Abilify Maintena continues its robust growth
FINANCE Abilify Maintena continues its robust growth • Grew 23% (20% in L.C.) to DKK Abilify Maintena sales per region* Abilify Maintena sales* 1,961 million in 2019 (Quarterly - DKKm) (FY - DKKm) • Continued solid traction in value +23% 600 2.000 share gains North America +22% • >25%: Australia, Ca
Slide 40: Northera shows solid growth in sales and demand
FINANCE Northera shows solid growth in sales and demand • Grew 29% (22% in L.C.) to Northera sales Northera sales DKK 2,328 million in 2019 (Quarterly - DKKm) (FY – DKKm) • Volume is up 8%1) compared to 900 2.700 +29% Q4 2018 +38% • Northera impacted by normal quarterly fluctuations driven by 600 1.
Slide 41: Solid growth in Europe and International Markets; North America adjusted for Onfi
FINANCE Solid growth in both Europe and International Markets, and North America grew when adjusted for Onfi North America revenue International Markets revenue Europe revenue (FY - DKKm) (FY - DKKm) (FY - DKKm) 12.000 +11% 3.500 +9% -11% 4.000 10.000 3.500 3.000 Other 3.000 2.500 products Other 8.0
Slide 42: 2-6% revenue growth expected for 2020
FINANCE 2-6% revenue growth expected for 2020 - earnings impacted by investments in eptinezumab • Continued strong growth for strategic brands 2020 financial guidance • Increased uncertainty in China DKK FY 2019 FY 2020 following the corona virus outbreak actual guidance • Substantial investments in
Slide 43: Financial position solid despite acquisitions and elevated investment levels
FINANCE Financial position solid despite acquisitions and elevated investment levels Selected cash flow figures Selected balance sheet figures DKKm FY 2019 Q4 2019 DKKm 31.12.2019 31.12.2018 Intangible assets 23,399 8,023 Cash flows from operating 2,609 394 Total assets 35,757 23,011 activities Equi
Slide 44: Selected deliverables for 2020
SUM-UP Selected deliverables for 2020 H1 2020: • Canadian submission for eptinezumab • U.S. PDUFA action date on eptinezumab (21 February) • Launch eptinezumab in the U.S (April) • Phase IIa headline results (AMBLED) for foliglurax (Parkinson’s) • Phase IIa headline results for Lu AG06466 (Tourette’
Slide 45: Readying Lundbeck for a new growth phase – 2020 and beyond
SUM-UP Readying Lundbeck for a new growth phase – 2020 and beyond • Trintellix launched in Japan Strategic brands - • Rxulti launched in Europe momentum continues Near-term • New LCM studies ongoing with brexpiprazole Invigorate Mid-term Accelerate • Launch eptinezumab in migraine prevention globall
Slide 46: Thank you
Thank you 46 Lundbeck
Slide 47: Total molecule sales (gross) - USDm
APPENDIX Total molecule sales (gross) - USDm 1.250 1.200 1.000 1.000 +58% 800 750 +80% 600 500 400 250 200 0 0 2014 2015 2016 2017 2018 2014 2015 2016 2017 2018 1.000 • Abilify Maintena: US approval (Feb. 2013); EU approval (Nov. 2013) 800 +161% 600 • Brintellix/Trintellix: US approval (Oct. 2013);
Slide 48: Solid volume growth in the U.S. for all strategic brands
APPENDIX Solid volume growth in the U.S. for all strategic brands +14% 100.000 +20% 800.000 +17% +26% 75.000 600.000 50.000 400.000 25.000 200.000 0 0 Q4.17 Q4.18 Q4.19 Q4.17 Q4.18 Q4.19 +8% 300.000 12.000 -1% +19% +29% 9.000 200.000 6.000 100.000 3.000 0 0 Q4.17 Q4.18 Q4.19 Q4.17 Q4.18 Q4.19 Source
Slide 49: Foliglurax is a potential new treatment for Parkinson's disease
FOLIGLURAX Foliglurax is a potential new treatment for Parkinson’s disease PD-LID is the most important unmet medical need after disease modification in Levodopa-induced mGluR4 PAM Parkinson’s1) dyskinesia3) Dyskinesia PD-LID affects ~50% after 5-10 years increasing to ~90% after 10-15 years of L- D
Slide 50: Phase IIa study (AMBLED) investigating foliglurax
FOLIGLURAX Phase IIa study (AMBLED) investigating foliglurax near final recruitment Study objective1 Phase IIa Evaluate the efficacy, safety and Two active arms (10mg and 30mg) + placebo tolerability of 28-Day oral treatment with foliglurax in ~165 patients (Europe) reducing motor complications of l
Slide 51: Lu AF28996: A potentially new oral treatment for Parkinson's
APPENDIX - EARLY PROJECTS Lu AF28996: A potentially new oral treatment for Parkinson’s patients experiencing motor fluctuations D1/D2-type agonists Lu AF28996 Phase I studies1: • Single- and sequential- Known to be highly efficacious A highly potent agonist at the D1- ascending-dose of Lu AF28996 to
Slide 52: Lu AF82422: Potential disease modifying antibody for Parkinson's
APPENDIX - EARLY PROJECTS Lu AF82422: Potential disease modifying antibody for Parkinson’s disease Pathological alpha-synuclein is Pathogenesis of Parkinson’s Ongoing phase I study3: released to extracellular space • Healthy non-Japanese and upon cell death and can mediate Japanese subjects and in s
Slide 53: Lu AG09222: Potential to build a migraine franchise with PACAP mAb
APPENDIX - EARLY PROJECTS Lu AG09222: Potential to build a migraine franchise in the future with early-stage PACAP2 inhibitor mAb A differentiated approach to migraine prevention • Highly potent and selective humanized PACAP binding antibody • Preclinical data1 indicate that PACAP2 and CGRP3 have di
Slide 54: Several new projects in clinical development
APPENDIX - EARLY PROJECTS Several new projects in clinical development Lu AF88434 Lu AF87908 Lu AF95245 • Potent and selective phosphodi- • Tau mAb • Kv7 (KCNQ) ion channels are esterase PDE1B inhibitor important regulators of neuronal • Binding to and inhibition of excitability • PDE1 is an intrace
Slide 55: Europe and International Markets have returned to strong dynamic growth
APPENDIX - FINANCE Europe and International Markets have returned to strong dynamic growth Regional growth Sales by region# • Strong improvement in both growth and profitability in Europe (FY 2019 - DKKm) (FY 2019) • International Markets shows solid growth driven by Australia, Japan, -11% North Ame
Slide 56: Cash flow impacted by lower EBIT and acquisitions
APPENDIX - FINANCE Cash flow impacted by lower EBIT and acquisitions, but solid cash generation still provides flexibility • Net cash flow: Down DKK 2,065 million to DKK -598 million in 2019 Net cash flow (Quarterly - DKKm) • FY 2020 cash flow will be negatively 1.800 impacted by 1.200 • Investments
Slide 57: Product distribution of revenue – Q4 and FY 2019
APPENDIX - FINANCE Product distribution of revenue – Q4 and FY 2019 DKKm FY 2019 FY 2018 Q4 2019 Q4 2018 Growth Growth in local % of total currencies TOTAL: Abilify Maintena 1,961 1,595 504 415 22% 20% 11% Brintellix/Trintellix 2,826 2,182 803 639 26% 23% 18% Cipralex/Lexapro 2,314 2,257 505 363 39%
Slide 58: Cash generation
APPENDIX - FINANCE Cash generation DKKm Q4 2019 Q4 2018 FY 2019 FY 2018 Cash flows from operating activities 394 1,406 2,609 5,981 Cash flows from investing activities (7,357) (609) (7,755) (2,907) Cash flows from operating and investing (6,963) 797 (5,146) 3,074 activities (free cash flow) Cash flo
Slide 59: Balance sheet and dividend
APPENDIX - FINANCE Balance sheet and dividend DKKm 31.12.2019 31.12.2018 Dividend (DKK) Intangible assets 23,399 8,023 15 5% Other non-current assets 3,320 3,339 Dividend 12 4% Current assets 9,038 11,649 Yield (r.h.s.) 9 3% Assets 35,757 23,011 Equity 14,554 14,251 6 2% Non-current liabilities 10,9
Slide 60: Costs – Full year figures
APPENDIX - FINANCE Costs – Full year figures DKKm 2019 2018 2017 2016 2019 (∆%) 2018 (∆%) Revenue 17,036 18,117 17,234 15,634 (6%) 5% Cost of sales 3,385 3,456 3,881 4,082 (2%) (11%) Sales & Distribution costs 5,514 5,277 5,649 5,488 4% (7%) Administrative expenses 899 762 833 805 18% (9%) R&D costs
Slide 61: For more information, please contact Investor Relations
INVESTOR RELATIONS For more information, please contact Investor Relations • Listed on the Copenhagen Stock Number of shares 199,136,725 IR contact Exchange since 18 June 1999 Treasury shares 366,019 (0.2%) Palle Holm Olesen Insider holdings 122,665 (0.06%) VP; Head of Investor Relations • Deutsche