H. Lundbeck A/s Class A · OMXCOP:HLUN_A
H. Lundbeck A/s Class A — Lundbeck — Q1 2021 Earnings Presentation
78 slides from H. Lundbeck A/s Class A's earnings presentation, May 11, 2021
Slide 1: Financial results & business update Q1 2021
Financial results & business update Q1 2021 11 MAY, 2021
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. Forward looking statements include, without limitation, any statement that may predict,
Slide 3: Encouraging financial performance in Q1 2021
Q1 2021: HIGHLIGHTS Encouraging financial performance in Q1 2021 Q1 2021 Q1 2020 Key developments in the first quarter of 2021: Sales growth, y/y (L.C.) -2.4% 6.8% • Revenue: Strategic brands up 8% (L.C.) – The robust EBITDA margin 31.6% 31.3% Q1 2021 impacted by Northera LoE, FX headwind and Core E
Slide 4: The four strategic brands grew 8% in local currencies in Q1 2021
Q1.2021: PRODUCT PERFORMANCE The four strategic brands grew 8% in local currencies in Q1 2021 Key brand revenue (Q1 2021 – DKKm and L.C. growth) • Strategic brands*: Sales unchanged y/y (up 8% in L.C.) at DKK 2,136 million representing 51% of total revenue Brintellix/Trintellix +7% • Brintellix/Trin
Slide 5: Vyepti shows continued strong momentum in vial demand
Q1 2021: PRODUCT PERFORMANCE Vyepti shows continued strong momentum in vial demand • Vyepti reached sales of DKK 76 Vyepti demand (weekly - vials) million. Fully in line with our expectations • Strong access to U.S. lives covered • The uptake in the beginning of 2021 is impacted by the normal deduct
Slide 6: Vyepti is the most powerful treatment for migraine that provides immediate prevention
Vyepti is the most powerful treatment for migraine that provides immediate prevention, diminishing the uncertainty that impacted patients live with, so they can take back control of their lives. “ I felt like there was this whole new world opening up to me. I don’t experience migraines anymore. I ca
Slide 7: Rexulti and Trintellix NRx recover swiftly when promotional activity improves
Q1 2021: PRODUCT PERFORMANCE Rexulti and Trintellix NRx recover swiftly when promotional activity improves Rexulti demand (U.S.)* Trintellix demand (U.S.)* (Monthly - NRx) (Monthly - NRx) 50,000 120,000 49,000 115,000 48,000 110,000 47,000 105,000 46,000 45,000 100,000 44,000 10,000 43,000 5,000 0 0
Slide 8: Strong momentum for Brintellix/Trintellix
Q1 2021: PRODUCT PERFORMANCE Strong momentum for Brintellix/Trintellix • Total product sales grew 7% in L.C. to DKK 804 million in Trintellix market share in Japan Q1 2021 4% (volume) • Volume share generally sustained or increased in most 3% markets • Volume growth negatively impacted by the COVID-
Slide 9: Several products delivered healthy performance despite continued COVID-19 effects
Q1 2021: FINANCIAL PERFORMANCE Several products delivered healthy performance despite continued COVID-19 effects From Q1 2020 sales to Q1 2021 sales • Encouraging performance considering COVID- 19 effect on diagnosis and treatments • Strategic brands up 8% in local currencies • Strong momentum for V
Slide 10: Healthy underlying performance in Q1 2021
Q1 2021: FINANCIAL PERFORMANCE Healthy underlying performance in Q1 2021 DKKm Q1 2021 Δ% y/y EBITDA margin reached 31.6% vs. 31.3% in Q1 2020 Revenue 4,273 -6% Gross margin 77.9% -2.8pp Operational expenses 2,445 -28% EBIT increased 235% reaching DKK 882 - SG&A 1,528 -11% million - R&D 917 -45% EBIT
Slide 11: 2021 impacted by depreciation of main currencies
Q1 2021: FINANCIAL PERFORMANCE 2021 impacted by depreciation of main currencies Q1 2021 sales by currency* Main currencies (1 January 2020 = index 100) EUR • 83% of sales in non-EUR 109 Other 17% currencies 105 23% 101 • USD directly represents 49% of sales 97 93 CAD 4% • The three main currencies 8
Slide 12: Cash flow impacted by lower EBITDA, working capital and dividend payment
Q1 2021: FINANCIAL PERFORMANCE Cash flow impacted by lower EBITDA, quarterly fluctuations in working capital and dividend payment Free cash flow (DKKm) Net cash & Net debt/EBITDA (DKKm) 1,208 9,000 1.5 6,000 1.0 4,552 3,292 774 3,000 0.5 681 975 0 0.0 -3,000 -0.5 -3,500 Net debt/EBITDA (r.h.s.) -4,7
Slide 13: 2021 financial guidance confirmed
Q1 2021: FINANCIAL PERFORMANCE 2021 financial guidance confirmed FY 2021 considerations FY 2021 financial guidance Revenue DKKm FY 2020 FY 2021 Actual Guidance • Continued solid growth of Abilify Maintena, Brintellix/Trintellix and Rexulti Revenue 17,672 16.3 ̶ 16.9bn • Strong momentum for Vyepti to
Slide 14: R&D progression
Q1 2021: RESEARCH & DEVELOPMENT R&D progression Vyepti • DELIVER study reached full enrollment ahead of plan; headline results expected in Q3 • The pivotal program for Asia initiated with the SUNLIGHT-study, SUNRISE soon to commence • Regulatory process ongoing in 12 markets Rexulti • Interim analys
Slide 15: RECONNECT: Vortioxetine improves depressive and anxiety symptoms in MDD with comorbid GAD
Q1 2021: RESEARCH & DEVELOPMENT RECONNECT: Vortioxetine improves depressive and anxiety symptoms in MDD with comorbid GAD patients Demographic and baseline characteristics 100 Mean age: Working Mean MADRS total score: 29.5 Inadequate Female: patients 42.2 years patients: 65% Mean HAM-A total score:
Slide 16: RELIEVE: Vortioxetine significantly improves patients overall functioning
Q1 2021: RESEARCH & DEVELOPMENT RELIEVE: Vortioxetine significantly improves patients overall functioning in global real world study Demographic and baseline characteristics 994 patients Mean age: Female: Working Mean MDD Patients w/ comorbid enrolled 49.3 years 64% patients: 56% duration: 11 years
Slide 17: Committed, leading and diverse organization
Q1 2021: ESG Committed, leading and diverse organization ESG update • Lundbeck remains in top 5% of comparable, international workplaces* • Five Lundbeck affiliates recognized as top employer in 2021 so far • Seven nationalities on The Board including three women Three elements in Lundbeck’s new cli
Slide 18: Key news flow
Q1 2021: SUM-UP Key news flow H1 2021 Canada approval of Vyepti achieved Planned interim analysis using Rexulti in Alzheimer’s agitation (phase III) Vyepti approval in Australia H2 2021 Finalizing phase II study using Rexulti in Borderline Personality Disorder Phase II planned to commence for Lu AF8
Slide 19: We are off to a good start despite challenging COVID-19 environment
Q1 2021: SUM-UP We are off to a good start despite challenging COVID-19 environment • Robust underlying financial performance • Key brands continue showing underlying growth • Vyepti delivers strong growth with global rollout soon to commence • Agitation in Alzheimer's Disease study with Rexulti
Slide 20: Q&A
Q&A
Slide 21: Readying Lundbeck for a new growth phase
Q1 2021: INTRODUCTION Readying Lundbeck for a new growth phase • Strategic brands provide strong, predictable long-term growth • Transformative launch of Vyepti began in 2020 • Highly efficient global infrastructure • Resilient, cash generative portfolio of mature brands • Expanding pipeline with pr
Slide 22: Our ambition - To be #1 in Brain Health
Q1 2021: INTRODUCTION Our ambition - To be #1 in Brain Health Providing transformative outcomes to patients in the highly attractive commercial areas of niche and rare disease neurology and niche psychiatry • Recognized as #1 in Brain Health by patients and other stakeholders globally • Premier neur
Slide 23: Progress made on our 'Expand and Invest to Grow' journey has informed our future indication focus
Q1 2021: CORPORATE 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 comm
Slide 24: Our future medicines will provide a step-change in outcomes
Q1 2021: CORPORATE STRATEGY Our future medicines will provide a step-change in outcomes to patients with difficult to treat brain diseases… 2020 Future focus Four biological clusters, Refined operating space: enabling wide disease area reach and innovation Targeted indications Indication groups 2019
Slide 25: R&D – Investing for a premier neuroscience pipeline
Q1 2021: – RESEARCH & DEVELOPMENT R&D – Investing for a premier neuroscience pipeline Project Biology Area Phase I Phase II Phase III Filing Eptinezumab (anti-CGRP mAb) Migraine prevention Eptinezumab (anti-CGRP mAb) Hormonal / neuropeptide Episodic cluster headache signaling Lu AG09222 (PACAP mAb)
Slide 26: Rexulti 2 mg/day potential for treatment of agitation in Alzheimer's
Q1.2021: RESEARCH & DEVELOPMENT Data from the two studies suggest that Rexulti 2 mg/day has the potential to be an efficacious, safe and well-tolerated treatment for AAD Study 283: Fixed dose study Study 284: Flexible dose study (post hoc) Fast Track designation granted February Mean change from bas
Slide 27: Agitation affects some 50% of patients with dementia
Q1 2021: RESEARCH & DEVELOPMENT Agitation affects some 50% of patients with dementia and is an important predictor of institutionalization Delusions, hallucinations, aggression, and agitation ~80% of AAD patients are in the community setting, affect ≥50% of patients with Alzheimer’s disease where go
Slide 28: Sustainability update
Q1 2021: ESG UPDATE Sustainability update • Lundbeck has significantly improved its ESG ratings in 2020 • New reporting format to increase our disclosure of relevant sustainability information for investors • Task Force on Climate-related Financial Disclosures (TCFD) Reference Index Key performance
Slide 29: Diverse portfolio across products and regions with geographical footprint aligned to global CNS market
Q1 2021: FINANCIAL PERFORMANCE Diverse portfolio across products and regions with geographical footprint well aligned to global CNS market Lundbeck product diversity Lundbeck geographic split* Global CNS market split** Sales by product (Q1 2021) Sales by region (Q1 2021) Sales by region (FY 2019) 14
Slide 30: Underlying performance for major strategic brands remains strong
Q1 2021: PRODUCT PERFORMANCE Underlying performance for major strategic brands remains strong Brintellix/Trintellix Rexulti Abilify Maintena (DKKm and L.C. growth) (DKKm and L.C. growth) (DKKm and L.C. growth) 4,000 3,000 3,000 +17% +13% +25% +17% 3,000 +26% +20% 2,000 2,000 2,000 +32% +21% +5% +23%
Slide 31: Vyepti global roll-out brings significant growth potential
Q1 2021: PRODUCT PERFORMANCE Vyepti global roll-out brings significant growth potential • The market for prophylactic migraine treatments in value is expected to grow considerably in the Prevalent cases of migraine coming years Region Migraine • Approved in three and currently submitted for prevalen
Slide 32: Product distribution of revenue – Q1 2021 and FY 2020
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Product distribution of revenue – Q1 2021 and FY 2020 DKKm FY 2020 FY 2019 Q1 2021 Q1 2020 Growth Growth in local % of total currencies TOTAL: Abilify Maintena 2,271 1,961 584 612 (5%) - 14% Brintellix/Trintellix 3,102 2,826 804 817 (2%) 7% 19% Cipralex/Lexapr
Slide 33: Continued excellence in commercial execution for the strategic brands
Q1.2021: APPENDIX – PRODUCT PERFORMANCE Continued excellence in commercial execution for the strategic brands; impact from COVID-19, FX and Q1 reset in the U.S. 1,000 800 +48% North America +36% -2% North America -6% 800 Europe+Int. Markets Europe+Int. Markets 600 600 400 400 200 200 0 0 Q1.18 Q1.19
Slide 34: Volume growth in the U.S. impacted by the pandemic (TRx Count)
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Volume growth in the U.S. impacted by the pandemic (TRx Count) 125,000 -1% 800,000 +22% +15% -8% 100,000 +27% +17% 600,000 75,000 400,000 50,000 200,000 25,000 0 0 Q1.18 Q1.19 Q1.20 Q1.21 Q1.18 Q1.19 Q1.20 Q1.21 +43% 300,000 -2% 120 +22% +29% 200,000 60 100,00
Slide 35: Total molecule sales (gross) - USDm
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Total molecule sales (gross) - USDm 1.250 1.600 1.000 +46% 1.200 750 +67% 800 500 250 400 0 0 2014 2015 2016 2017 2018 2019 2014 2015 2016 2017 2018 2019 • Abilify Maintena: U.S. approval (Feb. 2013); EU approval (Nov. 1.200 2013) 800 • Brintellix/Trintellix:
Slide 36: Solid financial performance driven by key brand portfolio
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Solid financial performance driven by key brand portfolio Key brands’ sales Core revenue and EBIT (FY - DKKm) (FY - DKKm) 3,200 18,117 17,672 17,234 17,036 2,800 15,634 14,464 2,400 13,468 Strategic brands 2,000 CAGR: +65% 1,600 1,200 6,158 Abilify Maintena 5,
Slide 37: Europe – limited impact from COVID-19
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Europe – limited impact from COVID-19 Abilify Maintena Brintellix Rexulti (Monthly - Volume) (Monthly - volume) (Monthly - Volume) 1,700,000 16,000,000 60,000 1,650,000 15,500,000 55,000 15,000,000 50,000 1,600,000 14,500,000 45,000 1,550,000 14,000,000 40,000
Slide 38: International Markets – Strong growth for Abilify Maintena and Rexulti
Q1 2021: APPENDIX – PRODUCT PERFORMANCE International Markets – Strong growth for Abilify Maintena and Rexulti Abilify Maintena Brintellix/Trintellix Rexulti (Monthly - Volume) (Monthly - volume) (Monthly - Volume) 700,000 7,600,000 400,000 7,400,000 650,000 350,000 7,200,000 300,000 600,000 7,000,0
Slide 39: Brintellix/Trintellix: 7% growth – solid underlying performance
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Brintellix/Trintellix: 7% growth – solid underlying performance continues to confirm the efficacy of its profile • Grew 7% in L.C. to DKK 804 million in Q1 Brintellix/Trintellix sales per region Brintellix/Trintellix sales 2021 (Quarterly - DKKm) (FY - DKKm) 1
Slide 40: Rexulti: Growing 4% – an effective drug meeting patient needs
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Rexulti: Growing 4% – an effective drug that is meeting patient needs in several new markets • Grew 4% in L.C. to DKK 672 million in Rexulti sales per region*** Rexulti sales*** Q1 2021 (Quarterly - DKKm) (FY - DKKm) • Continued solid traction in market 800 3,
Slide 41: Abilify Maintena: LAI market continues solid growth
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Abilify Maintena: LAI market continues solid growth • Unchanged in local currencies at DKK Abilify Maintena sales per region*** Abilify Maintena sales*** 584 million in Q1 2021 (Quarterly - DKKm) (FY - DKKm) • Continued robust traction in volume share*) 800 2,
Slide 42: Cipralex/Lexapro – Adjusted for FX, sales were unchanged
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Cipralex/Lexapro – Adjusted for FX, sales were unchanged • Declined 8% (flat in L.C.) to DKK Cipralex/Lexapro Cipralex/Lexapro 666 million in Q1 2021 (Quarterly - DKKm) (FY – DKKm) • Main growth drivers were Saudi 900 3,000 North America Arabia and several sma
Slide 43: Northera: sales impacted by generic erosion from February 2021
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Northera: sales impacted by generic erosion from February 2021 • Declined 35% (29% in L.C.) to Northera sales Northera sales (Quarterly - DKKm) (FY – DKKm) DKK 348 million in Q1 2021 following introduction of several 900 3,000 generics +10% • Northera currentl
Slide 44: Other pharmaceuticals
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Other pharmaceuticals • Declined 15% (11% in L.C.) to Other pharmaceuticals Other pharmaceuticals DKK 661 million in Q1 2021 (Quarterly - DKKm) (FY – DKKm) • Around 15 mature products 900 3,600 included -15% -12% • Biggest products are Azilect, 2,700 Cipramil,
Slide 45: Other revenue
Q1 2021: APPENDIX – PRODUCT PERFORMANCE Other revenue • Declined 41% (40% in L.C.) to Other revenue Other revenue DKK 81 million in Q1 2021 (Quarterly - DKKm) (FY – DKKm) • Q1 2021 impacted by quarterly 300 750 fluctuations in shipments -26% • Mostly contract manufacturing to utilize excess capacity
Slide 46: Regional performance impacted by FX headwinds, base effect and generic erosion
Q1 2021: APPENDIX – REGIONAL PERFORMANCE Regional performance impacted by FX headwinds, base effect from last year and generic erosion Regional growth Sales by region* • North America impacted by generic erosion, base effect from (Q1 2021 – DKKm and in L.C. %) (Q1 2021) strong Q1 2020 and impact fro
Slide 47: Robust performance across all three regions
Q1 2021: APPENDIX – REGIONAL PERFORMANCE Robust performance across all three regions considering impact from pandemic and currency headwind North America revenue International Markets revenue Europe revenue (Q1 - DKKm) (Q1 - DKKm) (Q1 - DKKm) 3,000 1,500 1,500 -11% -6% Other 2,000 1,000 products 1,0
Slide 48: Aripiprazole 2-Month formulation: Potential to further maximize the franchise
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Aripiprazole 2-Month formulation: Potential to further maximize the franchise Aripiprazole 2-Month formulation: • PK-based bridging approach to establish similar exposure between aripiprazole 2- Month Ready to Use (RTU) formulation and Abilify Maintena • Pa
Slide 49: PTSD offers an exciting opportunity for Rexulti
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT PTSD offers an exciting opportunity for Rexulti PTSD PoC study* Post-traumatic Stress Disorder (PTSD) epidemiology Rexulti (with placebo) as monotherapy ~8.6m U.S. adults affected, but or combination therapy in adults with >8m – U.S. prevalence ~80% estimat
Slide 50: Both studies in Rexulti pivotal programme in PTSD ongoing
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Both studies in Rexulti pivotal programme in PTSD ongoing Two studies initiated in the pivotal programme (phase III) Study objective1 Rexulti (fixed 2, 3mg and flexible dose up to 3mg) in combination To evaluate the efficacy, safety, and with sertraline tol
Slide 51: Borderline Personality Disorder offers an exciting opportunity for Rexulti
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Borderline Personality Disorder offers an exciting opportunity for Rexulti 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
Slide 52: Rexulti PoC study in Borderline Personality Disorder ongoing
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Rexulti PoC study in Borderline Personality Disorder ongoing Study objective1 Phase II To evaluate the efficacy and safety Rexulti (flexible dose 2-3mg) and placebo of 12-week Rexulti for the treatment of subjects diagnosed with Primary endpoint: Zanarini R
Slide 53: Migraine prevention represents a large and under served market
Q1 2021: APPENDIX – 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 head
Slide 54: Share of patients diagnosed and treated is increasing
Q1 2021: VYEPTI – EPTINEZUMAB Share of patients that are diagnosed and treated is increasing – from 27% to 39% since September 2019 Migraine prevention market: 13.9m1, 2 Diagnosed, Untreated; Diagnosed, 47% untreated Breakout of 39% treated group Untreated, Preventive Treatment % of Use undiagnosed
Slide 55: Two large pivotal studies demonstrated sustained efficacy and good tolerability
Q1 2021: VYEPTI – 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
Slide 56: PROMISE 1: Phase III study of Vyepti in frequent episodic migraine
Q1 2021: VYEPTI – EPTINEZUMAB PROMISE 1: A phase III study to evaluate the efficacy and safety of Vyepti for prevention of frequent episodic migraine • Vyepti reaching statistical significance for the primary and all key secondary endpoints • Migraine day prevalence dropped over 50% on Day 1 and red
Slide 57: Vyepti achieved meaningful reductions in migraine activity as early as Day 1
Q1 2021: VYEPTI – EPTINEZUMAB Vyepti 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 m
Slide 58: HIT-6 is a widely used patient-reported outcome measure
Q1 2021: VYEPTI – 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
Slide 59: Vyepti: PROMISE-2 sub-group analysis in medication-overuse headache
Q1 2021: APPENDIX – RESEARCH AND DEVELOPMENT Vyepti: Data from sub-group analysis of PROMISE-2 in patients with medication-overuse headache presented at AHS 2020 Vyepti reduced mean days of acute headache medication use - including triptans specifically - by ~50% over Weeks 1–12 in patients with chr
Slide 60: Positive headline results from the Vyepti RELIEF study
Q1 2021: APPENDIX – RESEARCH AND DEVELOPMENT Positive headline results from the Vyepti RELIEF study* Vyepti demonstrated… • statistical significance on the co-primary endpoints • all secondary endpoints were also statistically significant, including: • proportion of patients with pain freedom, and…
Slide 61: Vyepti: Phase IIIb study, DELIVER, commenced in June 2020
Q1 2021: APPENDIX – RESEARCH AND DEVELOPMENT Vyepti: Phase IIIb study, DELIVER, commenced in June 2020 Study objective: • Evaluate Vyepti in the prevention of migraine in patients with unsuccessful prior preventive treatments • Documented evidence of treatment failure in the past 10 years of 2-4 dif
Slide 62: Vyepti: Phase III study for treatment of cluster headache
Q1 2021: APPENDIX - RESEARCH & DEVELOPMENT Vyepti: Phase III study for treatment of cluster headache, a crippling pain with few effective medications currently available Cluster headache affects approximately one in 1,000 ALLEVIATE phase III study to evaluate Vyepti in people across the world episod
Slide 63: Lu AF82422: Potential disease modifying antibody for Parkinson's
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Lu AF82422: Potential disease modifying antibody e.g. for Parkinson’s disease or other synucleopathies Pathological alpha-synuclein is Pathogenesis of Parkinson’s Ongoing phase I study3: released to extracellular space upon • Healthy non-Japanese and cell d
Slide 64: Lu AG09222: Potential to build a migraine franchise with PACAP inhibitor mAb
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Lu AG09222: Potential to build a migraine franchise in the future with early-stage PACAP2 inhibitor mAb A differentiated approach to migraine Phase I study4: prevention • Determine the safety, tolerability • Highly potent and selective and pharmacokinetics
Slide 65: Lundbeck La Jolla biology platform exploring serine hydrolases
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT 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 indicati
Slide 66: Broad MAGLipase program initiated
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Broad MAGLipase program initiated Lu AG06466 Lu AG06479 • Inhibitor of the monoacylglycerol lipase • MAGL inhibitor (MAGL) and selective modulator of the endocannabinoid system Ongoing phase I study3 Ongoing phase Ib study in PTSD1 • Single-ascending oral d
Slide 67: Lu AF28996: A potentially new oral treatment for Parkinson's
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Lu AF28996: A potentially new oral treatment for Parkinson’s patients experiencing motor fluctuations D1/D2-type agonists Lu AF28996 Phase I studies: • Single- and sequential- Known to be highly efficacious A highly potent agonist at the D1- ascending-dose
Slide 68: Alzheimer's project with new MoAs in clinical development
Q1 2021: APPENDIX – RESEARCH & DEVELOPMENT Alzheimer’s project with new MoAs in clinical development Lu AF87908 • Tau mAb • Binding to and inhibition of pathological seeding form of Tau • Specific and pathology directed mAb • Retaining the capacity to mediate active clearance of Tau Ongoing phase I
Slide 69: Focus research in four biology clusters
Q1 2021: APPENDIX – RESEARCH & 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
Slide 70: Core operating profit maintained at robust level
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Core operating profit maintained at robust level Q1 2021 Q1 2021 core EBIT reconciliation (DKKm) 1,253 0 0 • Core EBIT reached DKK 1,253 million in Q1 371 882 2021 • Amortizations increased mainly due to Vyepti Q1 2020 Reported EBIT Amortization Impairment I
Slide 71: Cash flow impacted by debt repayment, but solid cash generation
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Cash flow impacted by debt repayment, but solid cash generation still provides flexibility • FY 2021: Cash flow negatively impacted by: Net cash flow (Quarterly - DKKm) • Repayment of term loan in February 1,800 • Lower revenue base due to Northera 1,200 LoE
Slide 72: Cash position, funding and debt maturity
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Cash position, funding and debt maturity • A diversified and long term balanced debt portfolio is a priority to Debt maturity profile Lundbeck (EURm equivalent) • This includes access to various funding sources as well as a 1,500 (4+1+1+1)* balanced maturity
Slide 73: Evolution in Lundbeck's main currencies
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Evolution in Lundbeck’s main currencies Largest currencies Spot Lundbeck’s Average Average (1 January 2020 = index 100) May 4, hedging H1 2020 H2 2020 108 2021 rate USD/DKK CAD/DKK USD 619.08 641.45 677.47 630.52 106 CNY/DKK JPY/DKK KRW/DKK 104 CAD 502.68 47
Slide 74: Cash generation
Q1 2021: APPENDIX – FINANCIAL PERFORMANCEE Cash generation DKKm Q1 2021 Q1 2020 FY 2020 FY 2019 FY 2018 Cash flows from operating activities 108 188 3,837 2,609 5,981 Cash flows from investing activities (84) (68) (467) (7,755) (2,907) Cash flows from operating and investing 24 120 3,370 (5,146) 3,0
Slide 75: Balance sheet and dividend
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Balance sheet and dividend DKKm 31.03.2021 31.12.2020 Dividend (DKK) Intangible assets 23,133 22,738 15 5% Other non-current assets 3,225 3,186 Dividend 12 4% Current assets 8,107 10,105 Yield (r.h.s.) 9 3% Assets 34,465 36,029 Equity 17,223 16,973 6 2% Non-
Slide 76: Costs – Full year figures
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Costs – Full year figures DKKm 2020 2019 2018 2020 (∆%) 2019 (∆%) Revenue 17,672 17,036 18,117 4% (6%) Cost of sales 4,166 3,840 3,911 8% (2%) Sales & Distribution costs 5,946 5,514 5,277 8% 4% Administrative expenses 966 899 762 7% 18% R&D costs 4,545 3,116
Slide 77: Lundbeck has a clear growth ambition based on current brand portfolio
Q1 2021: APPENDIX – FINANCIAL PERFORMANCE Lundbeck has a clear growth ambition and further possibility to grow based on current brand portfolio Lundbeck revenue 1999 – 2021e (FY - DKKm) Expected growth drivers: • Rexulti: Continued strong growth including LCM activities (e.g. Alzheimer’s agitation)
Slide 78: For more information, please contact Investor Relations
INVESTOR RELATIONS For more information, please contact Investor Relations IR contact • Listed on the Copenhagen Stock Number of shares1 199,148,222 Exchange since June 18, 1999 Treasury shares1 449,896 (0.23%) Palle Holm Olesen Insider holdings1 137,878 (0.07%) VP; Head of Investor Relations • Deut