Lundbeck Q3 2019 Financial Results

Made public by

sourced by PitchSend

28 of 68

Creator

Lundbeck logo
Lundbeck

Category

Healthcare

Published

2019

Slides

Transcriptions

#1704 Investor & Analyst Presentation November 2019 Lundbeck *#2Company 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. EVGB LOFTS TO 3 BEDS FROM $3.685 LUXURY RENTALS BOW LEASING Abyen WELCOME LUNDBECK TO THE NASDAQ NTERNATIONAL SELECT DESIGNATION Lundbeckx /Nasdaq NETFLIX 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 US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited. 2 Lundbeck#3Lundbeck in brief SPECIALIZED IN BRAIN HEALTH ➤ ~70 years of expertise in CNS ➤ Among the first to develop and market antipsychotics 70 yrs REVENUE (FY2018) -60% generated in North America China 2nd largest market -$2.8bn GLOBAL PRESENCE ➤ Headquartered in Denmark ➤ Operating in 50+ countries 50+ HISTORY Lundbeck was founded by Hans Lundbeck in 1915 in Copenhagen 1915 OWNERSHIP Largest shareholder is the Lundbeck Foundation, which annually grants DKK 400-500 million to research ● 70% 3 EMPLOYEES -5,500 Lundbeck#49M 2019 highlights: Continued strong performance of strategic brands and executing on our Expand and Invest to Grow strategy 4 +29% Strategic Brands +24% in local currencies • Strategic brands constitute 53% of revenue +8% International Markets Strategic brands grew 38% and constitute 18% of revenue Strong demand in general +7% Europe Strategic brands grew 27% and constitute 51% of revenue Strong demand in general • . Expand and Invest to Grow • Acquisition of Alder Transaction completed on 22 Oct. Eptinezumab submitted in the U.S. PDUFA action date: 21 Feb. 2020 Pipeline expansion • . Eptinuzumab (LCM) Phase III: Brexpiprazole PTSD Phase II: Brexpiprazole BPD Three projects enter phase I Solid cash position • Net cash Net cash 9M. 19: DKK 4,024m Net debt FY2019e: DKK -7bn following closure of Alder transaction Lundbeck#5Lundbeck's four strategic brands* added DKK 1.5 billion in sales in 9M 2019 compared to 9M 2018 5 Strategic brands*: Up 29% (24% in L.C.) to DKK 6,706 million representing 53% of revenue Strategic brands' growth (9M 2019 - DKKm) * Brintellix/Trintellix: Up 31% to Brintellix/Trintellix DKK 2,023 million * * Rexulti/Rxulti: Up 35% to DKK 1,620 million Northera: Up 25% to DKK 1,606 million Rexulti * Abilify Maintena: Up 23% to DKK 1,457 million Northera +25% Abilify Maintena 0 200 +23% 400 +31% Sales split* (9M 2019) 11% +35% Abilify Maintena 16% Brintellix/Trintellix 47% *) Abilify Maintena, Brintellix/Trintellix, Northera and Rexulti/Rxulti #) Excluding effects from hedging 600 Northera Rexulti/Rxulti Mature products 13% 13% Lundbeck#6Brintellix/Trintellix continues its significant growth momentum +33% 2.400 * Grew 31% (28% in L.C.) to DKK I 2,023 million in 9M 2019 Brintellix/Trintellix sales (Quarterly DKKm) Continued solid traction in 1800 North America volume share gains Int. Markets *>2.5%: Finland, France, Italy, Europe 600 Norway, South Korea, Spain, Switzerland * In the U.S., volume is up 22% y/y in Q3 20191) 400 Trintellix approved in Japan in September 1) Symphony Health (cf. Bloomberg) 6 200 2.000 Brintellix/Trintellix sales (9M - DKKm) 1.600 1.200 800 400 T +31% 0 Q3.17 Q3.18 Q3.19 9M.17 9M.18 9M.19 Lundbeck#7Rexulti shows significant growth driven by demand - roll-out in new markets continues 7 Rexulti sales* (Quarterly DKKm) +30% 1.800 Grew 35% (27% in L.C.) to DKK 1,620 million in 9M 2019 I 600 * In the U.S., volume is up 22% y/y in Q3¹) North America Other regions Launched in North America, selected European markets and Australia, Chile, Mexico and Saudi Arabia Phase III programme in PTSD²) commenced in October 2019 * Phase II study in BPD³) commenced in October 2019 1) Symphony Health (cf. Bloomberg) 2) Borderline Personality Disorder. 3) Post-Traumatic Stress Disorder 400 200- Q3.17 Q3.18 Q3.19 1.500 1.200 900 600 300 *) Lundbeck's share of revenue Rexulti sales* (9M - DKKM) +35% 9M.17 9M.18 9M.19 Lundbeck#8Abilify Maintena continues its robust growth Abilify Maintena sales* * Grew 23% (21% in L.C.) to DKK 1,457 million in 9M 2019 I (Quarterly DKKm) - * * Abilify Maintena is Lundbeck's best selling product in Europe LAI market continues double- digit growth to USD 3.8bn (9M) 600 1.500 North America +24% Int. Markets 500 Europe 1.200 400 Abilify Maintena's share of the LAI market is 17% compared to 16% in FY20181) 300 * Findings from PRELAPSE trial²) 200 to be presented at ACNP in December 1) Reported net sales of atypical LAIS 2) NCT02360319 8 100 0 Q3.17 Q3.18 900 600 300 Abilify Maintena sales* (9M - DKKM) +23% 0 Q3.19 9M.17 9M.18 9M.19 *) Lundbeck's share of revenue Lundbeck#9Northera shows solid growth in sales and demand Grew 25% (18% in L.C.) to DKK 1,606 million in 9M 2019 I Northera sales (Quarterly - DKKm) +38% 1.750 Volume is up 18% 1) compared to Q3 2018 600 1.500 Northera impacted by normal quarterly fluctuations driven by e.g. seasonality and pharmacies' buying pattern Lundbeck only promotes Northera in the U.S. 1) Symphony Health (cf. Bloomberg) 9 450 300 150 0 Q3.17 Q3.18 Q3.19 1.250 1.000 750 500 250 Northera sales (9M - DKKm) +25% 9M.17 9M.18 9M.19 Lundbeck#10North America - strategic brands up 28% in 9M 2019 North America revenue (9M - DKKm) North America - strategic brands (Quarterly DKKm) * Declined 14% (19% in L.C.) to DKK 6,937 million in 9M 2019 I 9.000 2.000 Total sales impacted by generic introductions of clobazam in October 2018 -14% 8.000 7.000 * Excluding Onfi, sales up 13% in 6.000 1.500 Other products 9M 2019 5.000 A 1.000 Strategic brands# grew 28% to Abilify Maintena 4.000 DKK 4,912 million and Trintellix constituted 71% of revenue in 9M 2019 3.000 Northera 500 2.000 10 1.000 0 9M.18 9M.19 #) Abilify Maintena, Northera, Rexulti and Trintellix REXULTI +32% Q3.17 Q3.18 Q3.19 Lundbeck#11International Markets - strategic brands up 38% in 9M 2019 * Grew 8% (8% in. L.C.) to DKK 3,022 million in 9M 2019 I Strategic brands# grew by 38% to DKK 549 million and constituted 18% of sales in 9M 2019 3.200 2.800 I 2.400 Rexulti increases from DKK 11 million to DKK 28 million 2.000 International Markets revenue (9M - DKKm) +8% Other products 240 180 International Markets - strategic brands (DKKm) +44% 11 Cipralex/Lexapro down 3% to DKK 1,283 million Main markets are Brazil, China, Japan and South Korea constituting -50% of sales in the region 1.600 1.200 800 400 0 9M.18 120 60 60 REXULTI A Abilify Maintena Brintellix 0 9M.19 Q3.17 Q3.18 Q3.19 #) Abilify Maintena, Rexulti and Brintellix/Trintellix Lundbeck#12Europe - strategic brands up 27% in 9M 2019 Europe revenue (9M - DKKm) +7% 500 Europe strategic brands (Quarterly DKKm) * Grew 7% (6% in L.C.) to DKK 2,417 million in 9M 2019 I Strategic brands# grew 27% to 2.600 DKK 1,245 million and 2.400 constituted 51% of sales in 9M 2019 2.200 2.000 1.800 Continued strong performance 1.600 for both Abilify Maintena and Brintellix 1.400 1.200 * Largest markets are France, Italy 1.000 and Spain constituting ~45% of sales in the region 800 600 400 200 0 12 9M.18 #) Abilify Maintena, Rxulti/Rexulti and Brintellix 9M.19 400 Other products 300 EXULTI 200- Abilify Maintienic 100 Brintellix +25% 0 Q3.17 Q3.18 Q3.19 Lundbeck#13Expand and Invest to Grow has significantly strengthened the pipeline Project Indication/label expansion Phase I Phase II (POC) Phase III Eptinezumab (anti-CGRP mAb) Eptinezumab (anti-CGRP mAb) Migraine prevention Brexpiprazole Filing * -2021 *** КККК ККККК Brexpiprazole Brexpiprazole Foliglurax (mGluR4 PAM) Lu AF11167 (PDE 10 inhibitor) Lu AG06466 (MGLLI) Abilify Maintena 2-mth Lu AF82422 (alpha-synuclein mAb) Lu AF28996 (D₁/D₂ agonist) Lu AG06466 (MGLLI) Lu AF88434 (PDE1b inhibitor) Lu AG09222 (PACAP mAb) Lu AF87908 (Tau mAb) "Treat and Prevent", migraine Agitation in Alzheimer's disease PTSD Borderline Personality Disorder Parkinson's disease Schizophrenia Tourette Syndrome Schizophrenia Parkinson's disease Parkinson's disease Neuropatic pain Alzheimer's, schizophrenia (CIAS) ≥2023 ≥2025 -2025 ≥2025 ≥2025 -2021 >2025 >2025 >2025 >2025 >2025 >2025 Migraine Alzheimer's 13 CGRP: Calcitonin gene-related peptide. mGluR4 PAM: Positive Allosteric Modulator of metabotropic glutamate receptor 4. PDE: Phosphodiesterases. MGLLI: Monoacylglycerol lipase inhibitor ("MAGlipase). PACAP: Pituitary adenylate cyclase-activating peptide. Lundbeck#14Lundbeck continues to execute on its Expand and Invest to Grow strategy through the acquisition of Alder BioPharmaceuticals 大 Maintaining the former Alder site in Bothell, just outside of Seattle, Washington in the U.S. Integration progressing rapidly 大 Main focus on biopharmaceutical product development and supply Financing and closing complete Eptinezumab * U.S. PDUFA action date: 21 Feb. 2020 Planned fillings: Canada (Q1.20), EU (by end-2020) Preparing the path for China, Japan and emerging markets Market Access * * Initiating phase IIIb study to facilitate EU market access Building insights and relationships to prepare global markets Expanding eptinezumab * Drive Treat & Prevent study * Define and pursue future indications 14 Landbec⭑#15Eptinezumab has the potential to transform the treatment paradigm for migraine prevention * 15 Eptinezumab will serve a large underserved patient population in a seriously debilitating disease Eptinezumab provides a differentiated clinical profile * Rapid onset of prevention by Day 1 driven by IV formulation and 100% bioavailability * * * * Strong response rate data from two phase III studies Good tolerability profile similar to placebo Quarterly 30-minute administration: Potentially increased compliance for improved outcome Alternative for patients uncomfortable with self injection POWERFUL ≥50%, ≥75% and 100% reductions in migraine days FAST Onset of prevention Day One post-infusion SUSTAINED for 3 months following a single administration and sustained or further increased with subsequent infusions Lundbeck#16Two large pivotal studies including -2,000 patients demonstrated sustained efficacy and good tolerability PROMISE 1 in Episodic Migraine Patients (N=888; baseline -9 migraine days/month) PROMISE 2 in Chronic Migraine Patients (N=1,072; baseline - 16 migraine days/month) Met primary and all key secondary endpoints Good tolerability profile at both dosage levels POWERFUL ≥50%, ≥75% and 100% reductions in migraine days FAST Onset of prevention Day One post-infusion * Met primary and key * secondary endpoints * Good tolerability profile at all dosage levels * 16 + SUSTAINED for 3 months following a single administration and sustained or further increased with subsequent infusions Lundbeck#17Significant reduction in monthly migraine days (MMDs) with eptinezumab at both 100mg and 300 mg Eptinezumab has shown high response rates, especially in adult patients experiencing frequent, chronic migraine ~60% of patients had ≥50% PROMISE-1 (Change from baseline in MMDs) 0 -2 PROMISE-2 (Change from baseline in MMDS) 17 * * reduction in migraine days ~40% of patients had ≥75% reduction in migraine days Patients that experienced no migraines for at least half of the study period (≥3 mth): 100mg: 14.0% 300mg: 19.1% *Placebo: 4.9% -3,2 -4 -6 -5,6 -6,2 -3,8 -8 -3,9 -7,7 キ -8,2 -8,2 -4,3 t -8,8 -4,5 -4,8 -10 Infusion 1 (Months 1-3) Infusion 1 (Months 1-3) Infusion 2 (Months 4-6) Infusion 2 (Months 4-6) Eptinezumab 100mg Placebo Eptinezumab 300mg Eptinezumab 100mg Eptinezumab 300mg Placebo *p=0.0182; tp=0.0001; #p<0.0001 vs placebo. Months 4-6 were not included in the prespecified statistical algorithms. Lundbeck#18Eptinezumab demonstrated rapid onset from Day 1 Key secondary endpoint: Percentage reduction on Day 1 I PROMISE-1 PROMISE-2 35% Eptinezumab 100 mg 60% PROMISE 1: -Eptinezumab 300 mg 30% --Placebo 50% Eptinezumab 100 mg Eptinezumab 300 mg -Placebo * Eptinezumab 100mg: 52.3% 25% * Eptinezumab 300mg: 54.9% Placebo: 24.5% Percent of Patients 40% Average 20% baseline % of patients with migraine on any given day: -30% Average baseline % of patients with 30% migraine on any given day: + 15% 10% PROMISE 2: 10% 5% * Eptinezumab 100mg: 50.3% 0% 0% BL Day 1 Wk 1 Wk 2 Wk 3 Wk 4 BL Day 1 Wk 1 Wk 2 Wk 2 Wk 4 -58% 20% 18 Eptinezumab 300mg: 51.6% * Placebo: 27.1% *p=0.0159 vs placebo, unadjusted; +p=0.0312 vs placebo, unadjusted; p<0.0001 vs placebo. 1. Saper J, Wilks K, Chakhava G, et al. Eptinezumab for the Prevention of Episodic Migraine Through 1 Year: Results from the Phase 3 PROMISE-1 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-1) Trial. Presented at: 2019 American Academy of Neurology Annual Meeting: Philadelphia, PA; May 4-10, 2019. $38.003 2. Kudrow D, Lipton R, Silberstein S, et al. Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) Trial. Presented at: 2019 American Academy of Neurology Annual Meeting: Philadelphia, PA; May 4-10, 2019. P2.10-006 Lundbeck#19Eptinezumab treatment well-tolerated across doses as compared to placebo Safety and tolerability were evaluated in the PROMISE 1 and PROMISE 2 trials In pooled data assessment across the two trials, nasopharyngitis (swelling of the nasal passages and the back of the throat) was the only AE occurring at an incidence of 2.0% or greater than placebo Other AEs included upper respiratory infection, nausea and urinary tract infection, arthralgia (joint pain), dizziness, anxiety and fatigue, which all occurred at a similar incidence to placebo (less than 2% difference vs. placebo) in the pooled data set I Adverse reaction occurring with an incidence of ≥2% for either dose of eptinezumab and ≥2% greater than placebo for PROMISE 1 and PROMISE 2 Adverse reactions Nasopharyngitis Eptinezumab 100 mg every 3 months N=579 6% Eptinezumab 300 mg every 3 months N=574 Placebo every 3 months N=588 8% 6% Saper J, Wilks K, Chakhava G, et al. Eptinezumab for the Prevention of Episodic Migraine Through 1 Year: Results from the Phase 3 PROMISE-1 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-1) Trial. Presented at: 2019 American Academy of Neurology Annual Meeting: Philadelphia, PA; May 4-10, 2019. $38.003 Kudrow D, Lipton R, Silberstein S, et al. Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) Trial. Presented at: 2019 American Academy of Neurology Annual Meeting: Philadelphia, PA; May 4-10, 2019. P2.10-00 19 Lundbeck#20Eptinezumab - Powerful, Fast and Sustained action Eptinezumab promise * Rapid onset of prevention by Day 1 driven by IV formulation and 100% bioavailability, addressing unmet medical need * Strong response rate data from two phase III studies * Good tolerability profile similar to placebo at all dosages * Only prevention treatment available as an IV formulation * Quarterly administration: Potentially increased compliance for improved outcome * Alternative for patients uncomfortable with self injection * ~70% of ~2,000 target headache specialists/neurologists have capabilities to provide in-office IV therapies 20 20 Lundbeck#21Eptinezumab - Exciting upcoming newsflow with interesting LCM potential Regulatory: * ★ * U.S. PDUFA action date: 21 February 2020 Expected submission in Canada (Q1 2020), EU (by end 2020), followed by submissions for approval in other regions around the world Ongoing studies: * RELIEF study started in November 2019 (n = ~450) There are several life cycle management opportunities Indication RELIEF study - "Treat & Prevent" (NCT04152083) Assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those patients who are candidates for preventive therapy. Subjects will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4. Other potential indications - Medication overuse headache - Cluster headache Post-concussion headache - Other pain syndroms 21 Landbec⭑#22~18m individuals are candidates for prevention - less than 50% are treated³ Migraine is one of the most debilitating diseases globally Most disabling disease for people under 50 years - the most productive years of people's lives¹ Attacks usually last 4-72 hours² Symptoms include extreme pain, nausea, vomiting, extreme sensitivities to light and sound, gastrointestinal issues Significant unmet medical needs remain with existing preventive treatments, including speed of onset Chronic migraine often leads to depression, anxiety, and sleep disturbances² 1) Steiner, TJ, Stovner, LJ, & Vos, T. The Journal of Headache and Pain (2018) 19:17 ."Most disabling disease of people under 50 years old." 2) Migraine Research Foundation. Migraine Facts. Available at: https://migraineresearchfoundation.org/about- migraine/migraine-facts/. Accessed January 2, 2019. 3) Decision Resources: DRG 2018 Migraine Market report 222 Lundbeck ⭑#23Migraine profoundly affects patients' lives 93% say migraine affects their ability to work1 89% say migraine affects their ability to maintain relationships with a partner¹ 86% say migraine affects their ability to maintain relationships with children¹ Only 4/10 are satisfied with their current migraine treatment¹ Patients value efficacy and onset of efficacy regardless of the mode of administration * 87% rate effectiveness as important in determining whether they accept treatment (highest-rated)² ★ 79% rate fast acting as an important treatment feature when considering migraine prevention² 1) Chronic Migraine in America Survey Results of 3923 individuals living with migraine, 2016. Presented by migraine.com. 2) Alder proprietary patient market research, 2017 (N=250). 23 Lundbeck#24Migraine prevention represents a large and under served market Addressable population (major countries¹) Migraine is divided into two major categories, episodic and chronic depending on the frequency of headaches 1-14 migraine days per month >14 migraine I days per month 24 -134m - Migraine prevalence ~41m - diagnosed patients (30%) ~18m - Eligible for prevention (43%) -9m - Currently on prophylactic treatment 1) Decision Resource, DRG 2018 Migraine Market report. Covers G7+China Episodic Frequent episodic I Acute treatment <4 migraine days per month Chronic Migraine prevention >4 migraine days per month Lundbeck#25Both studies in brexpiprazole pivotal programme in PTSD commenced Post-traumatic Stress Disorder (PTSD) * ~8.6m U.S. adults affected, but -80% estimated to be undiagnosed * Growing economic and social burden of care * Inadequate response with approved SSRIs - polypharmacy the norm Study objective¹) To evaluate the efficacy, safety, and tolerability of 12-week brexpiprazole + sertraline combination treatment in adult subjects with PTSD (n = ~600) Two studies in the pivotal programme (phase III): * Brexpiprazole (fixed dose (2, 3mg) and flexible dose up to 3mg) in combination with sertraline * * Primary endpoint: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score U.S. dedicated study 1) Clinicaltrials.gov ID: NCT04124614. The second study not listed yet 25 Lundbeck ⭑#26Brexpiprazole PoC study in borderline personality disorder commenced Borderline Personality Disorder (BPD) * * * Pharmacotherapy focuses on key symptoms (aggression, irritability, depressed mood, behavioural dyscontrol and affective dysregulation, anxiety, psychoticism and hostility) Substantial unmet medical need - no drugs approved for BPD 1.5-2 million potential patients in the U.S. Study objective¹) To evaluate the efficacy and safety of 12-week brexpiprazole for the treatment of subjects diagnosed with BPD (n = 240) to provide a pharmacological treatment for BPD PoC study (phase II): * * Brexpiprazole (flexible dose 2-3mg) and placebo Primary endpoint: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score (Week 12) Secondary endpoints: Clinical Global Impression - Severity of Illness (CGI-S); Patient's Global Impression of Severity (PGI- S); Patient's Global Impression of Change (PGI-C) Scale; Clinical Global Impression - Improvement (CGI-I) Scale Headline results due in 2021 - Fast Track designation granted October 2019 1) Clinicaltrials.gov ID: NCT04100096 26 26 Lundbeck#27Third study in brexpiprazole pivotal programme in agitation Alzheimer's progresses as planned Agitation in Alzheimer's (AAD) >20% of individuals in a community setting and >50% of nursing home residents with dementia have agitation * * 1.5-2m dementia patients in the U.S. with agitation / aggression x No FDA approved medication * Associated with increased caregiver burden, decreased functioning, earlier nursing home placement Study objective¹) To compare the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type (n = ~225) Third study out of three in the pivotal programme (phase III): * Brexpiprazole (fixed dose 2mg and 3mg) and placebo ★ Primary endpoint: Cohen-Mansfield Agitation Inventory (CMAI) total score (Week 12) * Secondary endpoint: Clinical Global Impression Severity of Illness (CGI-S) score * Headline results due early 2021 - Fast Track designation granted February 2016 1) Clinicaltrials.gov ID: NCT03548584 27 Lundbeck#28Abide - adding new drug discovery platform with potential to deliver first-in-class compounds across multiple CNS indications The transaction: * Upfront payment: USD 250 ABIDETHERAPEUTICS million * Financed through existing Now Lundbeck La Jolla Research Center financial reserves * * Acquisition reached final Focused on Serine Hydrolase (S-H) biology approval on 29 May 2019 * to discover first in class S-H Future milestones: Up to USD inhibitors 150 million in R&D¹) and sales milestones²) Unique chemo-proteomic platform Headquarters: La Jolla, CA * * * Strong ties to The Scripps Research Institute (TSRI) and Dr. Cravatt Labs. * 1) Triggered when stat-sig. results in a phase II clinical trial in the Tourette's indication or first patient enrolled in a phase III trial in Tourette's using the lead compound. 2) First commercial launch and when revenue reach certain thresholds 25 Employees Serine hydrolase (S-H) Enzyme Superfamily One of the largest and most diverse enzyme classes in humans Profoundly influence multiple biological processes in health and disease Mood, pain, perception, movement, inflammation Selective inhibitors can restore physiological balance in dysregulated signalling pathways Multiple blockbuster drug classes from this family * DPP-4 inhibitors; AChE inhibitors; Thrombin inhibitors; Xa inhibitors 28 Lundbeck#29Lundbeck La Jolla Research Center now established ★ Transition of Abide to pure discovery site is completed * Lu AG06466 currently in phase lla progressing as planned Headline results due 2020 * Strong progress of the early portfolio ★ FIH for next project expected in 2020 29 Lundbeck#30First Target: Endocannabinoid modulation through MGLL inhibition - A compelling therapeutic target for a wide range of CNS diseases * * Monoacylglycerol lipase inhibitors (MGLLI) regulate endocannabinoid tone, which regulates neurotransmitter balance MGLLI selectively activate CB1 by elevating 2-AG levels only in active circuits - contrast with global, maximal, and sustained activation by exocannabinoids Lead molecule Lu AG06466 is a potent, selective first-in-class MGLLI in clinical development in two indications Two additional endocannabinoid modulators advancing to the clinic through 2020 MGLL inhibition Increased 2-AG regulates neuronal excitability and inflammatory processes Restore Homeostatic Balance Stress response Anxiety Reward processing Pain processing Motor function PTSD Multiple future potential indications in psychiatry and neurology Potential to use biomarkers to enrich patient populations MDD BPD Increased stress sensitivity 30 TS Lundbeck GAD#31Lu AG06466: First-In-Class drug with broad potential in CNS * * Lu AG06466 modulates the endocannabinoid system preferentially in areas where neuronal circuits are excessively activated Initial trials ongoing in Tourette's and neuropathic pain Phase lb trial in adult TS patients demonstrated significant effects across multiple endpoints of tic reduction 200,000 patients in U.S. with severe disease¹) 大 Exploratory phase Ila trial ongoing (NCT03625453) Initiated in October 2018 48 adult patients with Tourette's Part 1: 8 weeks with daily administration; Patients who choose to enter Part 2: additional 4 weeks with daily administration Change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) Headline results due in 2020 I Lu AG06466: First-in-Class drug with broad potential in CNS Neuropsychiatric disorders Movement disorders Initial indication • • • OCD Agitation ADHD Parkinson's Tardive dyskinesia Huntington's Tourette's 31 1) NIH - National Institute of Neurological Disorders and Stroke Lundbeck#32Foliglurax - an interesting new pipeline asset currently in PoC testing in Parkinson's patients * * * * 32 32 Increase activity of a specific glutamatergic target (mGluR4) Symptomatic treatment of OFF-time in Parkinson's and levodopa induced dyskinesia Strong IP Global rights to foliglurax and full control of asset Phase II started in July 2017 * Two active arms + placebo (BID) * ~165 patients (Europe) * Change in awake OFF time based on subject diary entries Levodopa-induced dyskinesia Dyskinesia ON time without dyskinesia OFF time Disease progression in patients with motor fluctuations Dyskinesia With ON time without dyskinesia addition of foliglurax (illustrative) OFF time 1) NCT03162874 Disease progression in patients with motor fluctuations Modified based on: Jankovic, Mov. Disorder 2005, Motor complications of levodopa * PD-LID is the most important unmet medical need after disease modification in Parkinson's²) * PD-LID affects -50% after 5-10 years increasing to -90% after 10- * 15 years of L-DOPA therapy 170-200,000 patients in the U.S. with PD-LID Once established, PD-LID is difficult to treat PD-LID: Parkinson's Disease - Levodopa-Induced Dyskinesia 2) Datamonitor Lundbeck#33Lu AF11167: Addresses negative symptoms of schizophrenia that trouble patients most * 33 Negative symptoms most bothersome symptom for patients with schizophrenia Primary cause for inability to live independently, hold jobs, establish personal relationships, and manage everyday social situations Widely recognized as important features of schizophrenia associated with changes in emotions and behaviours Difficult to treat; currently available antipsychotics are not considered effective Prevalence (major countries) 4.7m - Prevalence of schizophrenia (G7) * * Phosphodiesterase 10A inhibitor (PDE 10Ai) Potential novel MoA for the treatment of negative symptoms in patients with schizophrenia Potentially maintaining control of positive symptoms * 3.5m - Treatment prevalence (75%) * Phase II started in December 2018* 1.7m clinical stable outpatients (50%) * Monotherapy * Two fixed-flexible doses + 0.8m - Negative symptoms (40%) placebo (BID) ~250 patients Primary endpoint: Change from baseline to Week 12 in BNSS total score Source: Decision Resource; Schizophrenia | Landscape & Forecast 2018 *) NCT03793712. BNSS: Brief Negative Symptoms Scale Lundbeck#34Lu AF82422: Potential disease modifying antibody in Parkinson's Pathogenesis of Parkinson's (PD) Cellular aging Lewy body formation Genetic mutations activity Lu AF82422 is a human IgG1 mAb that recognizes all major alpha-synuclein forms including aggregated/misfolded forms involved in the pathogenesis of Parkinson's First single-ascending-dose study to evaluate safety and tolerability of Lu AF82422 in healthy volunteers and Parkinson's patients Intervention aimed for delay in disease progression in PD or other synucleinopathies Decreased chaperone Neuronal death Aggregated misfolded alpha-syn. Increased dopamine oxidation Defective processing of alpha-syn. Oxidative stress Mitochondrial dysfunction Toxins Ongoing phase I study1: * Healthy non-Japanese and Japanese subjects and in patients with Parkinson's -45 participants Primary endpoint: Number of patients with incidence of Treatment-Emergent Adverse Events (safety and tolerability) from dosing to Day 84 Study initiated in July 2018 34 Modified based on Javed et al. CNS & Neurological Disorders - Drug Targets, 2016, Vol. 15, No. 10 1) NCT03611569 Lundbeck#35Lu AF28996: A potentially highly efficacious oral treatment for Parkinson's patients experiencing motor fluctuations * Lu AF28996 is highly potent agonist at the D₁- and D₂-type dopamine receptors D₁/D₂-type agonists are known to be highly efficacious even in the later stages of Parkinson's, but the currently available agonist (apomorphine) cannot be delivered by oral route Parkinson's disease (moderate to advanced) as adjunct to L-DOPA (or monotherapy pending data) I Ongoing phase I study1: * * Single- and sequential- ascending-dose of Lu AF28996 to healthy young men -20 participants Open-label study investigating the safety, tolerability and pharmacokinetic profile of Lu AF28996 Study initiated in May 2018 35 1) NCT03565094 Lundbeck#36Lu AG06466 in phase lb study in neuropathic pain Neuropathic pain (NP) Ongoing phase I study1: 36 MGLLI have shown to reduce pain in preclinical models of inflammatory, post-surgical, and neuropathic pain Significant scientific evidence supports the use of exocannabinoids for the treatment of pain, including controlled clinical studies in patients with NP MGLLI may offer significant therapeutic benefits over exocannabinoids, with potential for increased NP results from damage to the nervous system in the brain or spinal cord or in the peripheral nerves * * * NP is a common and debilitating condition that may occur in 10% of Americans * * Current approved treatments for NP include gabapentinoids and antidepressants * Beyond the lack of effective medications, many patients chronically use opioid drugs * efficacy and a better safety profile Designed to identify a titration regimen of Lu AG06466 ~38 adult patients with peripheral neuropathic pain The efficacy of Lu AG06466 in treating neuropathic pain will be assessed by the change from baseline in pain intensity scores using numerical rating scale (NRS-11) Study initiated in Q4 2017 There is a pressing need for efficacious non-opioid therapies for NP 1) NCT03447756. This study will enrol patients with peripheral neuropathic pain due to one of the four following diagnostic groups: post-herpetic neuralgia, diabetic peripheral neuropathy, small fiber neuropathy or post-traumatic neuropathic pain 1) Lundbeck#37Three new projects enter first-in-humans testing Lu AF884341) Lu AF88434 is a potent and selective phosphodiesterase PDE 1b inhibitor (PDE1b-i) Lu AF879082) * Lu AF87908 is a humanized 大 IgG1 Tau mAb * SAD study in healthy SAD study investigating the safety, tolerability, PK/PD properties of Lu AF88434 * N = ~100 participants 大 N = ~66 participants PDE1 is highly expressed in brain regions involved in cognitive processing Potential cognitive enhancer - e.g. in schizophrenia and Alzheimer's (AD) * subjects and AD patients Delay disease progression in AD or other tauopathies ** 1) Clinicaltrials.gov ID: NCT04082325 37 2) NCT04149860 Immunoglobulin G1 (Ig) is types of antibodies (Ab) Lu AG09222 Lu AG09222 mAb inhibits pituitary adenylate cyclase- activating polypeptide (PACAP) N = ~100 participants PACAP is an important signalling molecule in the pathophysiology of migraine Landbec⭑#38Potential to build a migraine franchise in the future with ALD1910 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 differentiated pharmacology with respect to migraine-associated symptoms Potential for mono-therapy in non-CGRP induced migraine or combination therapy with eptinezumab RAMP VPAC1 VIP PACAP-38 VPAC2 PAC1 Kaiser, Russo: "CGRP and migraine: Could PACAP play a role too?", Neuropeptides, Volume 47, Issue 6, 2013 1) Loomis et al: Pharmacologic characterization of ALD1910, a potent humanized monoclonal antibody against the pituitary adenylate cyclase-activating peptide, JPET Fast Forward 2) Pituitary adenylate cyclase-activating peptide 3) Calcitonin gene-related peptide 38 Lundbeck#39Finance 39 ANNUAL REPORT 2015 LUNDBEC ARSRAPPOR 이 ANNUAL REPORT 2009 ANREJAL REPORT 20 Annual report 2010 PATIENTS PROGRESS IN MIND FOCUSED GLOBAL O SCHIZOPHRENIA PASSIONATE ALZHEIMER'S RESPONSIBLE PARKINSON'S INNOVATION LEADERSHIP PROFITABILITY ORGANIZATION ANNUAL REPORT 2015 * 439 2014 WE STRIVE FOR GLOBAL LEADERSHIP N PSYCHIATRY AND NEUROLOGY BY IMPROVING THE LIVES OF PATIENTS ANNUAL REPORT 2013 ANNUAL REPORT 2014 IN MIND ANNUAL REPORT 2016 ANNUAL REPORT 2017 Annual Report 2018 Lundbeck#40Alder represents a compelling opportunity to deliver long term sustainable growth Alder-related items impacting the 2019 guidance Transaction costs: Approximately DKK 200 million Integration and retention costs: DKK 400-500 million* Lundbeck's share of Alder's net burn: DKK 325-400 million Core EBIT only impacted by Alder's operational costs Lundbeck⭑ * * * Launch of eptinezumab will strengthen Lundbeck's growth profile for years to come Short term earnings dilution from investments in LCM and launch activities ★ U.S. sales force of around 100 people being established ★ Several LCM activities being evaluated Patent protection until mid- 2030's Lundbeck's balance sheet remains solid post transaction 40 Landbec⭑#41Strong financial performance Strong growth for strategic brands of 29% DKKm 9M 2019 A % y/y Q3 2019 A% y/y I Revenue 12,615 (9%) 4,135 (11%) Gross margin 80.7% -0.6pp 80.7% * Onfi decline of 69% in line Gross margin (core) 85.7% 85.9% +0.9pp with expectations Operating expenses 6,862 2% 2,327 2% Disciplined cost spend as OPEX up only 2.5% Financial performance leads to raised guidance SG&A 4,636 5% 1,598 8% R&D 2,226 (3%) 729 (11%) _1) -1) Other operating items, net EBIT 3,317 (26%) 1,012 (30%) EBIT margin 26.3% -5.7pp 24.5% -6.8pp Core EBIT margin 31.8% -5.7pp 31.0% -4.6pp Core EBIT 4,010 (23%) 1,281 (22%) Tax rate 27% 27% EPS 12.27 (25%) 3.78 (29%) 1) An expense of DKK 165 million in 9M 2018 and an expense of DKK 0 million in Q3 2018 41 Lundbeck#42Lundbeck's financial guidance for 2019 raised * Continued strong growth for strategic brands 2019 financial guidance * 2018 (DKKm) (DKKbn) Previous 2019e Revised 2019e (DKKbn) -0% (y/y) Revenue 18,117 16.3 -16.7 16.7 -16.9 -8% - -7% Expected negative impact from generic erosion Effects from hedging is a loss of around DKK 300 million OPEX from Alder and Abide# is included in guidance range Net financial items of DKK -100 - 0 million expected in 2019 Unchanged currencies from mid- October 2019 #) Now Lundbeck La Jolla Research Center 42 Core EBIT 6,158 4.6-5.0 4.8 - 5.1 -22% -17% Implied core EBIT margin 34.0% -28% -31% -28-31% EBIT 5,301 3.2-3.6 3.4-3.7 -36% -30% Implied EBIT margin 29.3% -19% -22% -20% -22% Tax rate 26.1% 26% -28% 26% -28% Lundbeck#43Solid financial position provides flexibility Net cash flow: Down DKK 1,326 million to DKK -632 million Net cash flow (Quarterly DKKm) 43 1.600 * FY 2019 cash flow will be negatively impacted by 1.200 Lower EBITDA Acquisition of Abide and Alder 800 400 * Dividend payout for 2018 0 Payment of DoJ settlement -400 -800 * Net debt: Expected to reach DKK -7 billion (USD -1bn) by end-2019 -1.200 -1.600 -2.000 Q3.17 Q3.18 Q3.19 Lundbeck#44Europe and International Markets have returned to strong dynamic growth * Strong improvement in both growth and profitability in Europe International Markets shows solid growth driven by Australia, Japan, Korea and South East Asia North America impacted by generic erosion, mainly Onfi Largest markets are the U.S., China, Canada, Spain, Italy, France and Japan constituting >70% of sales# Regional growth (9M 2019 - DKKm) North America International Markets +8% Europe +7% 44 Sales by region* (9M 2019) -14% 20% -1.500 -1.000 -500 0 500 North America International Markets Europe 24% 56% #) Excluding Other revenue and effects from hedging Lundbeck#459M 2019: Continued strong growth from strategic brands and negative impact from generic erosion on mature products as expected * Revenue: Down 9% (9% in L.C.) to DKK 12.6 billion I Revenue (9M - DKKm) -9% Core EBIT (9M - DKKM) -23% 14.000 5.500 Performance driven by strategic 13.000 brands mitigating effect from 5.000 12.000 EXULTI generics 4.500 11.000 10.000 Northera 4.000 Other revenue: Down 7% to 9.000 3.500 DKK 433 million Brintellix 8.000 Trintellix 3.000 7.000 Effects from hedging: Loss of Abilify Maintenc 2.500 6.000 DKK 194 million 5.000 2.000 I * Core EBIT margin: 31.8% vs. 4.000 1.500 37.5% in 9M 2018 following generic erosion of Onfi 3.000 Other pharma 1.000 2.000 500 1.000 Rest 0 0 9M.18 9M.19 9M.17 9M.18 9M.19 45 Lundbeck#46Cash flow impacted by acquisition of Abide, DoJ payment and higher dividend pay-out Cash flow from operating Operating cash flow activities: Declined 52% and (Quarterly DKKm) reached DKK 2,215 million in 9M 2.400 2019 following negative impact from working capital 2.000 Working capital: Payment of DoJ settlement and quarterly 1.600 fluctuations in short-term liabilities 1.200 Financing activities: Dividend pay- out increased from DKK 1.6 billion to DKK 2.4 billion 800 * Net cash outflow: DKK 632 million vs. an inflow of DKK 694 million last year 400 46 Q1 Q2 22 3 Q3 Net cash flow (Quarterly DKKM) 1.600 2017 1.200 2018 800 2019 400 о -400 -800 -1.200 -1.600 -2.000 +4 Q4 Q3.17 Q3.18 Q3.19 Lundbeck#47Core gross margin improved in Q3 2019 despite LOE on Onfi Cost of Sales (core): Down 10% to DKK 1,798 million in 9M 2019 * Gross margin (core): Unchanged from 9M 2018 * Operational expenses (core OPEX): Increased 2% to DKK 6,807 million in 9M 2019 1.000 500 0 2.700 Cost of sales and gross margin (core) Q3.17 Operational Expenses and OPEX ratio (core) Core gross margin (%) Cost of sales (DKKm) 90% 85% 80% Q3.18 Q3.19 Cost ratio (%) OpEx (DKKm) 75% 47 1.800 900 50% 0 25% Q3.17 Q3.18 Q3.19 Lundbeck#48Balance sheet is strong with limited debt and strong operating cash flow Assets (DKKbn) Liabilities (DKKbn) 48 Cash & cash equivalents: Declines following the acquisition of Abide, 23,0 23,5 23,0 23,5 increased dividend pay-out and payment of DoJ settlement 8,0 Working capital: Declines DKK Intangible assets 10,0 1.1bn as short term payables Equity 14,3 14,4 decline (eg. Doj payment) Property, 2,0 Plant & 1,3 equipment 2,5 Interest-bearing debt: Higher due to recognition of lease liabilities cf. 1,8 Financial 1,2 assets IFRS 16 1,7 3,3 Inventories 1,6 Provisions 1,7 0,1 Debt 0,7 3,6 Acquisition of Alder BioPharmaceuticals will increase leverage Receivables 6,6 Cash & cash equivalents 7,1 Payables 6,7 4,5 31 Dec. 2018 30 Sep. 2019 31 Dec. 2018 30 Sep. 2019 Lundbeck#49Selected deliverables for 2019 * Start PoC study on Lu AF11167 in schizophrenia Commence the launch of Rxulti/Rexulti in Europe * Pivotal data for Rexulti in bipolar mania * Headline results (POC) for foliglurax in Parkinson's (delayed to H1 2020) * Continue LCM activities on brexpiprazole 3 * Obtain approval of Trintellix in Japan * Achieve FIH in 1-2 R&D projects * Execute on Expand and Invest to Grow 49 Lundbeck#50Lundbeck continues its mission to restore brain health, leveraging a strong platform and heritage to grow Rebuild pipeline Solid financial foundation * Highly profitable with strong cash generation * Solid growth across key products ★ Global footprint with growth in all regions of the world * Long-standing reputation with patient communities and physicians * Deep scientific heritage and capabilities in CNS Promising early-stage pipeline * Demonstrated track record of partnering relationships Maximize Expand existing operating brands space Maintain focus on profitability Expand and Invest to Grow We will enhance organizational agility and collaboration 50 50 Lundbeck#51Thank you! Lundbeck#52Total molecule sales (gross) - USDM 52 NEW 1.250 Abilify Maintena 1.000 1.200 Trintellix 5mg-10mg-20mg tablets vortioxetine Brintellix vortioxetine 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 REXULTI 800 600 400 200 +161% 0 2015 2016 2017 2018 Source: IMS * * * Abilify Maintena: US approval (Feb. 2013); EU approval (Nov. 2013) Brintellix/Trintellix: US approval (Oct. 2013); EU approval (Dec. 2013); Japan approval (Sep. 2019) Rexulti: US approval (Jul. 2015); EU approval (Jul. 2018); Japan approval (Jan. 2018 - NOT Lundbeck territory) Lundbeck#53Lundbeck's strategic brands deliver strong double-digit revenue growth 53 NEW 400 CNC MONTHLY 750 Abilify Maintena North America 800 Europe+Int. Markets +24% 600 500 250 0 800 REXULTI 600 400 200 Q3.17 Q3.18 North America Europe+Int. Markets +30% Q3.19 400 200 0 600 300 Trintellix vortioxetine Brintellix 5mg-10mg-20mg tablets vortioxetine North America Europe+Int. Markets Northera™ (droxidopa) capsules 100mg-200mg-300 ng +33% Q3.17 Q3.18 Q3.19 +38% 0 0 Q3.17 Q3.18 Q3.19 Q3.17 Q3.18 Lundbeck Q3.19#54Solid volume growth in the U.S. for all strategic brands 100.000 75.000 50.000 25.000 NEW +17% Abilify Maintena +21% 800.000 0 Q3.17 300.000 REXULTI +31% 200.000 100.000 54 54 Q3.18 0 Q3.17 Q3.18 +22% Trintellix vortioxetine +22% 5mg-10mg 20mg tablets +24% 600.000 400.000 200.000 0 Q3.19 Q3.19 Northera™ 12.000 (droxidopa) capsules 100mg-200mg-300ng 9.000 6.000 3.000 0 Source: Symphony Health (ref Bloomberg) Q3.17 -14% Q3.18 Q3.19 +18% Q3.17 Q3.18 Lundbeck Q3.19#55Onfi impacted negatively by introductions of generic clobazam * Declined 69% (70% in L.C.) to DKK 840 million in 9M 2019 Numerous generic tablets and oral suspensions launched from October 2018 Aggressive generic pricing I 1.000 800 Onfi sales (Quarterly DKKm) 150.000 -76% 100.000 Onfi demand (Quarterly - TRX) -80% 55 600 Generic versions have taken ~80% of volume since October 2018 400 200 50.000 Q3.17 Q3.18 Q3.19 Q3.18 Q3.19 Source: Symphony Health (cf. Bloomberg) Lundbeck#569M 2019 and FY 2018 - Product distribution of revenue DKKm FY 2018 FY 2017 9M 2019 9M 2018 Growth Growth in local currencies % of total TOTAL: Abilify Maintena 1,595 1,333 1,457 1,180 23% 21% 12% Brintellix/Trintellix 2,182 1,663 2,023 1,543 31% 28% 16% Cipralex/Lexapro 2,257 2,392 1,809 1,894 (4%) (5%) 14% Northera 1,806 1,644 1,606 1,282 25% 18% 13% Onfi 3,165 3,022 840 2,669 (69%) (70%) 7% Rexulti/Rxulti 1,723 1,247 1,620 1,204 35% 27% 13% Sabril 1,342 1,509 643 983 (35%) (39%) 5% Other pharmaceuticals 3,143 4,074 2,378 2,392 (1%) (2%) 19% Other revenue 662 402 433 466 (7%) (7%) 3% Effects from hedging 242 (52) (194) 308 (2%) Total revenue 18,117 17,234 12,615 13,921 (9%) (9%) 100% 56 Lundbeck#579M 2019 and FY 2018 - Geographic distribution of revenue - 1 DKKm FY 2018 FY 2017 9M 2019 9M 2018 Growth Growth in local currencies % of total NORTH AMERICA: Abilify Maintena Trintellix 695 591 618 499 24% 17% 9% 1,239 974 1,103 853 29% 22% 16% Northera 1,806 1,644 1,606 1,282 25% 18% 23% Onfi 3,165 3,022 840 2,669 (69%) (70%) 12% Rexulti 1,702 1,245 1,585 1,193 33% 25% 23% Sabril 1,342 1,509 643 983 (35%) (39%) 9% Other pharmaceuticals 794 1,688 542 593 (8%) (13%) 8% Total revenue 10,743 10,673 6,937 8,072 (14%) (19%) 100% 57 Lundbeck#589M 2019 and FY 2018 - Geographic distribution of revenue - 2 DKKm FY 2018 FY 2017 9M 2019 9M 2018 Growth Growth in local currencies % of total EUROPE: Abilify Maintena 770 637 715 587 22% 21% 30% Brintellix 547 376 523 396 32% 31% 22% Cipralex 572 643 422 467 (10%) (10%) 17% Rexulti/Rxulti 7 Other pharmaceuticals 1,081 1,149 750 819 (8%) (9%) 31% Total revenue 2,970 2,805 2,417 2,269 7% 6% 100% INTERNATIONAL MARKETS: Abilify Maintena 130 105 124 94 32% 34% 4% Brintellix 396 313 397 294 35% 39% 13% Cipralex/Lexapro 1,552 1,582 1,283 1,324 (3%) (4%) 42% Rexulti 21 2 28 11 162% 160% 1% Other pharmaceuticals 1,401 1,404 1,190 1,083 10% 9% 40% Total revenue 3,500 3,406 3,022 2,806 8% 8% 100% 58 Lundbeck#599M 2019 and FY 2018 - Cash generation DKKm Cash flows from operating activities 9M 2019 9M 2018 2,215 Cash flows from investing activities (398) (2,298) 4,575 FY 2018 5,981 (2,907) Cash flows from operating and investing activities (free cash flow) 1,817 2,277 3,074 Cash flows from financing activities (2,449) (1,583) (1,607) Net cash flow for the period (632) 694 1,467 59 Cash, bank balances and securities, end of period Interest-bearing debt Net cash/(net debt) 4,512 5,356 6,635 (488) 4,024 5,356 6,635 Lundbeck#609M 2019 and FY 2018 - Balance sheet and dividend Dividend (DKK) DKKm Intangible assets Other non-current assets 30.09.2019 31.12.2018 15 5% 9,962 8,023 Dividend 3,706 12 4% 3,339 Yield (r.h.s.) Current assets 9,803 9 11,649 3% Assets 23,471 23,011 6 - 2% Equity 14,367 14,251 3 1% Non-current liabilities 1,878 1,184 0 0% 2010 2012 2014 2016 2018 Current liabilities 7,226 7,576 Equity and liabilities 23,471 * 23,011 Cash and bank balances 2,975 3,605 Securities 1,537 * 3,030 Interest-bearing debt Dividend payout of DKK 12.00 per share for 2018, corresponding to a payout ratio of 61% * A total of DKK 2.4 billion and a yield of 4.2%* Dividend policy: Payout ratio of 30-60% from 2019 (488) Interest-bearing debt, cash, bank balances and securities, net, end of period 4,024 6,635 *Based on the share price of DKK 285.40 00 60 Lundbeck#61Costs - Full year figures 61 DKKm 2018 2017 2016 2015 2018 (\%) 2017 (\%) Revenue 18,117 17,234 15,634 14,594 5% 10% Cost of sales 3,456 3,881 4,082 5,395 (11%) (5%) Sales & Distribution costs 5,277 5,649 5,488 6,706 (7%) 3% Administrative expenses 762 833 805 1,160 (9%) 3% R&D costs 3,277 2,705 2,967 8,149 21% (9%) Total costs 12,772 13,068 13,342 21,4101) (2%) (2%) EBIT 5,3012) 4,4082) 2,292 (6,816) 20% 92% Core EBIT 6,158 5,115 3,477 847 20% 47% Cost of sales 19% 23% 26% 37% Sales & Distribution costs 29% 33% 35% 46% Administrative expenses 4% 5% 5% 8% R&D costs 18% 16% 19% 56% EBIT margin 29% 26% 15% (47%) Included are 1) Restructuring costs and impairment of product rights of around DKK 7bn. 2) Includes Other operating items, net Lundbeck#62Financial terms and territory structure of the Otsuka alliance entered in November 2011 Milestone payments Payment to: Otsuka Abilify Maintena Lundbeck's share of revenue and costs Lundbeck⭑ Otsuka Lundbeck⭑ Abilify Maintena Rexulti Selincro 62 Rexulti Selincro Development milestones/upfront USD 200m USD 600m³) EUR 105m* USA 20% 45% Approval milestones USD 275m1) USD 300m²) Un- disclosed EU-5, Nordic and 50% 50% Canada Sales milestones Up to USD 425m depending on sales development Un- disclosed Other Lundbeck territories 65%** 65%** Un- disclosed * Includes sales milestones 1) USD 100m upon US approval, USD 75m upon EU approval in schizophrenia, and USD 50m US and EU for a second indication. 2) USD 100m (US) and USD 50m (EU) for each of the two first indications 3) Development milestones of up to USD 600m after which shared development costs between parties. 4) USD 125m, USD 25m and USD 50m for first indication in the US, EU and Japan respectively. Second indication gives USD 50m, USD 25m and USD 25m, respectively. ** All regions except Asia, Turkey and Egypt *** All regions except Thailand and Vietnam * Selincro for Japan added to the alliance in October 2013 Lundbeck#63For more information, please contact Investor Relations * Listed on the Copenhagen Stock Exchange since 18 June 1999 ! Number of shares Treasury shares * Deutsche Bank sponsored ADR programme listed on NASDAQ (U.S. OTC) effective from 18 May 2012 Insider holdings Classes of shares Restrictions 199,136,725 366,019 (0.2%) 122,665 (0.06%) IR contact Palle Holm Olesen 1 None * For additional company information, please visit Lundbeck at: www.lundbeck.com ISIN code Ticker symbol DK0010287234 LUN DC/LUN.CO (Bloomberg/Reuters) FY 2019 AGM ADR programme ADR symbol Sponsored level 1 HLUYY Q1 2020 6M 2020 Ratio 1:1 9M 2020 VP; Head of Investor Relations Mobile: +45 3083 2426 [email protected] or [email protected] Financial calendar 6 February 2020 24 March 2020 12 May 2020 13 August 2020 3 November 2020 63 Lundbeck

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare