Lundbeck Company Analysis - Report Store · follow-up Lexapro/Cipralex (escitalopram). However, given Lexapro’s May 2014 patent expiry in Europe, Lundbeck is aiming to maintain

Lundbeck Company Analysis

Ref Code: DMKC0135779Publication Date: 01/07/2016Author: Gunel Huseynova

CatalystUpdated analysis and forecasts based on 2015 company-reported sales.

Datamonitor HealthcarePharma intelligence |


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Lundbeck Company Analysis DMKC0135779 | Published on 01/07/2016

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Reference: DMKC0135779 First published: 01/07/2016

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TABLE OF CONTENTS

LIST OF FIGURES

LIST OF TABLES

4 EXECUTIVE SUMMARY

5 COMPANY CONTEXT5 Lundbeck6 Bibliography

7 FACTS AND FIGURES7 Lundbeck’s prescription pharma sales outlook7 Lundbeck’s top products over 2015–258 Lundbeck’s growth drivers and resistors11 Lundbeck’s therapy area dynamics13 Lundbeck’s launch/core/expiry analysis15 Lundbeck’s financial outlook16 Lundbeck’s M&A history18 Lundbeck’s key catalysts

19 KEY THERAPY AREAS19 Central nervous system24 Bibliography

5 Figure 1: Lundbeck's SWOT analysis7 Figure 2: Lundbeck’s prescription pharmaceutical sales ($m) and growth rate (%), 2012–257 Figure 3: Lundbeck’s top product sales ($m), 2015–2511 Figure 4: Lundbeck’s therapy area dynamics, 2015–2513 Figure 5: Lundbeck’s launch/core/expiry portfolio configuration ($m), 2015–2515 Figure 6: Lundbeck’s operating revenue/cost analysis ($m), 2009–2118 Figure 7: Lundbeck’s key events and catalysts

9 Table 1: Lundbeck’s key products, 2015–2512 Table 2: Lundbeck’s sales by therapy area ($m), 2015–2514 Table 3: Lundbeck’s sales by launch, core, and expiry portfolio ($m), 2015–2515 Table 4: Lundbeck’s financial performance ($m), 2015–2117 Table 5: Lundbeck’s key merger and acquisition deals, 2006–1620 Table 6: Lundbeck’s central nervous system portfolio sales, by product ($m), 2015–25


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EXECUTIVE SUMMARY Lundbeck’s prescription pharmaceutical

sales are forecast to increase out to 2025

During the forecast period of 2015–25, Datamonitor Healthcare forecasts Lundbeck’s prescription

pharmaceutical sales to increase at a compound annual growth rate (CAGR) of 5.9% seeing an overall growth

of $1.5bn.

Lundbeck is heavily focused on the CNS

market

In the late 1980s, managing director Erik Sprunk-Jansen refocused the company on pharmaceuticals, and in

particular on central nervous system (CNS) therapies, as a strategy to become one of the strongest players in

the field. This strategy is set to continue throughout the forecast period as Lundbeck’s CNS portfolio will

account for around 85% of total sales in 2025.

New launches and label expansions will

drive growth

New label expansions and launches will increase Lundbeck’s revenues during 2015–25. In order to offset the

sales decline and maintain its position in the depression market, Lundbeck is aiming to extend its lifecycle

management strategy by switching patients from Lexapro onto its novel depression drug Brintellix

(vortioxetine). Rexulti (brexpiprazole), the company’s follow-on offering in the schizophrenia market, will gain

market share from well-established antipsychotics and their generics, given its benign side-effect profile.

Lundbeck will maintain its longstanding presence in the Alzheimer’s disease market with idalopirdine.

Antidepressants will continue to form the

mainstay of Lundbeck’s growth trajectory

Lundbeck's established presence in CNS is driven by its development of Cipramil (citalopram) and blockbuster

follow-up Lexapro/Cipralex (escitalopram). However, given Lexapro’s May 2014 patent expiry in Europe,

Lundbeck is aiming to maintain its presence in the depression market through the launch of Brintellix

(vortioxetine) and Rexulti. Brintellix gained approval in the EU in December 2013 and Rexulti was approved in

the US in July 2015.


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COMPANY CONTEXT Lundbeck

Headquarters – Valby, Denmark

Chief executive officer – Kare Schultz

Total employees – 5,257

R&D margin – 20.3%

Gross margin – 65.6%

Profit margin – -1.1%.

Lundbeck’s flagship depression product Lexapro (escitalopram; marketed as Cipralex by Lundbeck inEurope) and Alzheimer's disease treatment Namenda/XR (memantine; marketed as Ebixa in Europe)have defined the company’s performance in the past, reflecting Lundbeck’s strategic focus on thecentral nervous system (CNS) market. However, these key brands are positioned as Lundbeck’s maingrowth resistors during the forecast period given their patent expiries over 2012–14. Lexapro lostpatent protection in May 2014 in the EU and in March 2012 in the US, while Namenda/XR’s EU patentexpired in April 2014. Nevertheless, Lundbeck will continue to generate revenues in the CNS marketthanks to Brintellix (vortioxetine), Rexulti (brexpiprazole), Abilify Maintena, idalopirdine, and LuAF35700, which are expected to largely maintain the company’s pharmaceutical revenues, with acompound annual growth rate of 8.3% over 2015–25. RESTRUCTURING PROGRAMME WILL AIM TO REDUCE COST BASE AND IMPROVE PROFITABILITYBY 2017

In August 2015, Lundbeck initiated a restructuring programme to improve profitability of thecompany by reducing costs by DKK 3bn ($453m) and refocusing the company’s efforts in R&D andcommercial activities (Lundbeck, 2015). Lundbeck will sharpen its focus on the following productportfolio: Abilify Maintena (aripiprazole), Brintellix (vortioxetine), Northera (droxidopa), Onfi(clobazam) and Rexulti (brexpiprazole). Datamonitor Healthcare expects the products to constitute59% of top line revenues in 2025, reaching $2,758m. The company has also announced that it willterminate early-phase projects outside core disease areas and will not expand the existing portfoliothrough external opportunities. As a result, Lundbeck will focus on driving growth with a focus onearly-stage research projects in four key disease areas – depression, schizophrenia, Alzheimer’s diseaseand Parkinson’s disease.


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Bibliography

Lundbeck (2015) Major restructuring to regain profitability and ensure value creation. Available from:http://investor.lundbeck.com/releasedetail.cfm?releaseid=928089 [Accessed 15 June 2016]

Figure 1: Lundbeck's SWOT analysis

Source: Datamonitor Healthcare


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FACTS AND FIGURES Lundbeck’s prescription pharma sales outlook

Lundbeck’s top products over 2015–25

Figure 2: Lundbeck’s prescription pharmaceutical sales ($m) and growth rate (%), 2012–25

Source: Datamonitor Healthcare; company-reported information


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Lundbeck’s growth drivers and resistors

Figure 3: Lundbeck’s top product sales ($m), 2015–25

Source: Datamonitor Healthcare; company-reported information (global)


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Table 1: Lundbeck’s key products, 2015–25

Product Generic

name

2 0 1 5

s a l e s

( $ m )

2 0 2 5

s a l e s

( $ m )

2015–2

5 sales

differen

ce ($m)

Notes

Rexulti brexpipra

zole

17 758 741 An oral dopamine partial agonist that was approved in 2015 in the US for major depressive disorder and schizophrenia. Currently undergoing Phase III trials for

Alzheimer’s disease and schizophrenia maintenance.

Brintellix vortioxeti

ne

94 470 377 Gained US and EU approvals for major depressive disorder in 2013. In 2015, the EMA approved label update to include cognitive benefits.

idalopirdi

ne

idalopirdi

ne

0 632 632 A 5-HT6 receptor antagonist undergoing Phase III trials for Alzheimer’s disease.

A b i l i f y

Maintena

aripiprazo

le

100 425 325 Once-monthly intramuscular depot formulation of aripiprazole indicated for the treatment of schizophrenia. Currently undergoing Phase III trials for bipolar disorder.

L u

AF35700

N/A 0 300 300 A 5HT-6 and dopamine D1 and D2 receptor antagonist undergoing Phase III trials for psychosis.

Cipralex escitalopr

am

385 203 -183 Depression drug with patent expiry in 2012 (US) and 2014 (5EU). Marketed by Forest in the US under brand name Lexapro.

Azilect rasagiline 217 26 -191 A selective, irreversible monoamine oxidase B inhibitor approved in the US and EU for the treatment of Parkinson’s disease.

5EU = five major EU markets (France, Germany,Italy, Spain, and the UK); 5-HT = serotonin


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Table 1: Lundbeck’s key products, 2015–25

Source: Datamonitor Healthcare; company-reported information


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Lundbeck’s therapy area dynamics

Figure 4: Lundbeck’s therapy area dynamics, 2015–25



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Table 2: Lundbeck’s sales by therapy area ($m), 2015–25

Primary therapy area 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

2 0 1 5 – 2 5

d i f f e r e n c e 2 0 1 5 – 2 5

C A G RCentral nervous system 1,965 1,815 1,998 2,326 2,474 2,904 3,295 3,401 3,423 3,446 3,473 1,508 5.9%

Cardiovascular 71 104 142 187 229 272 317 363 409 457 506 435 21.8%

Other 27 34 40 46 55 65 72 75 76 77 77 50 11.0%

Oncology 31 15 12 10 10 10 10 10 10 10 10 -21 -10.8%

Grand Total 2,094 1,967 2,192 2,569 2,767 3,251 3,694 3,848 3,918 3,990 4,066 1,972 6.9%



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Lundbeck’s launch/core/expiry analysis

Lundbeck’s product portfolio can be divided into three categories based on product lifecycle position:

Launch – Patented products launching between 2015 and 2025.

Core – Patented products that neither launch nor expire between 2015 and 2025.

Expiry – Patented products expiring (losing patent protection) between 2015 and 2025.

The distribution of changes in annual product sales between 2014 and 2024 across these categoriescan be used to dissect the drivers and resistors behind a company’s growth prospects.

Typically, launch products will generate high growth rates as they penetrate the addressable market,making a positive contribution to the change in annual sales between 2015 and 2025. In contrast,expiring products, if subject to generic competition, will experience a rapid sales decline, with theconsequence that the expiry category will often make a negative contribution to the change in annualsales between 2015 and 2025. The core category can make either a positive or a negative contributionto the change in annual sales between 2014 and 2024, depending on the sales performance of thecore marketed portfolio.

The figure and table below summarize Lundbeck’s launch, core, and expiry portfolio sales performanceover 2015 and 2025.

Figure 5: Lundbeck’s launch/core/expiry portfolio configuration ($m), 2015–25



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Table 3: Lundbeck’s sales by launch, core, and expiry portfolio ($m), 2015–25

L i f e c y c l e

s t a g e

2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2 0 1 5 – 2 5

d i f f e r e n c e

2 0 1 5 – 2 5

C A G R

Launch 17 81 177 367 701 1,048 1,350 1,547 1,657 1,709 1,738 1,721 58.5%

Core 1,231 890 909 952 992 1,035 1,081 1,129 1,177 1,227 1,277 45 0.4%

Expiry 845 996 1,106 1,250 1,074 1,168 1,262 1,173 1,084 1,054 1,051 206 2.2%

Grand Total 2,094 1,967 2,192 2,569 2,767 3,251 3,694 3,848 3,918 3,990 4,066 1,972 6.9%

Note:totals may not sum due to rounding.

CAGR= compound annual growth rate



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Lundbeck’s financial outlook

Datamonitor Healthcare uses multiple financial forecasts from reputable brokers to drive a consensus-level forecast. Ratios generated from this analyst-consensus forecast are then applied to DatamonitorHealthcare’s total revenue forecasts to generate a financial outlook.

Figure 6: Lundbeck’s operating revenue/cost analysis ($m), 2009–21

Source: Datamonitor Healthcare; company-reported information; analyst-consensus forecasts


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Lundbeck’s M&A history

Table 4: Lundbeck’s financial performance ($m), 2015–21

2015 ($m) 2021 ($m)

2 0 1 5 – 2 1

difference ($m) Notes

Rx revenue 2,094 3,694 1,600 -

Other revenue

77 47 -30 Includes revenue related to new partner

agreements and regulatory mi lestone

payments-

Total revenue 2,171 3,741 1,570 -

COGS -747 -544 -203 -

S,G&A -1,155 -1,314 160 -

R&D -441 -573 132 -

Operating profit

-172 1,310 1,138

-

Source: Datamonitor Healthcare; company-reported information; analyst consensus forecasts


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Table 5: Lundbeck’s key merger and acquisition deals, 2006–16

Year Acquired company Deal type Value ($m) Comments

2006 Saegis Pharmaceuticals 100% acquisition 820 US-based CNS specialist player

2009 Ovation

Pharmaceuticals

100% acquisition 900 US-based CNS specialist player

2009 NeuronIcon Majority acquisition n/a Denmark-based specialist research company focused on brain damage and brain disorder therapies

2009 LifeHealth 100% acquisition 147 Acquisition of UK-based firm to increase interest in Xenazine (tetrabenazine)

2009 Elaiapharm Majority acquisition n/a One of Lundbeck’s main subcontractors, providing manufacturing, packaging, and European distribution services

2014 Chelsea Therapeutics 100% acquisition 658 Acquisition of US-based firm to gain rights to Northera (droxidopa)

CNS = central nervous system

Source: Medtrack, June 2016; company-reported information (global)


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Lundbeck’s key catalysts

Figure 7: Lundbeck’s key events and catalysts



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KEY THERAPY AREAS Central nervous system

Launch momentum from Rexulti (brexpiprazole), Brintellix (vortioxetine) and idalopirdine is forecast toaccount for almost 54% of the CNS revenues in 2025. Through the development of Cipramil(citalopram) and Lexapro (escitalopram), Lundbeck has built a reputation for expertise in thedepression market. In the late 1980s, managing director Erik Sprunk-Jansen refocused the companyon pharmaceuticals, and in particular on central nervous system (CNS) therapies, as a strategy tobecome one of the strongest players in the field. This strategy is set to continue throughout theforecast period as Lundbeck’s CNS portfolio will account for around 85% of total sales in 2025.


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Table 6: Lundbeck’s central nervous system portfolio sales, by product ($m), 2015–25

Product 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

2 0 1 5 – 2 5

difference

2 0 1 5 – 2 5

C A G R

Rexulti 17 64 145 260 391 510 589 645 692 729 758 741 45.9%

idalopirdine 0 0 0 64 185 326 470 566 617 632 632 632 n/a

Brintellix 94 236 340 455 557 648 730 634 535 488 470 377 17.5%

Abilify Maintena 100 132 165 206 258 312 350 372 392 409 425 325 15.6%

Lu AF35700 0 0 0 0 77 164 243 287 300 300 300 300 n/a

Other CNS LUN 417 458 484 504 514 521 525 527 528 529 530 113 2.4%

IV carbamazepine 0 17 32 43 48 48 48 48 48 48 48 48 n/a

Sabril 147 104 62 42 36 34 35 35 35 35 35 -112 -13.4%

Cipralex 385 168 172 183 190 195 198 200 201 202 203 -183 -6.2%

Azilect 217 198 183 168 111 67 45 34 29 27 26 -191 -19.1%

Onfi 261 293 316 332 58 41 31 23 18 18 18 -244 -23.6%

Xenazine 327 145 99 68 49 37 32 29 28 28 28 -299 -21.7%

Total 1,965 1,815 1,998 2,326 2,474 2,904 3,295 3,401 3,423 3,446 3,473 1,508 5.9%


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Table 6: Lundbeck’s central nervous system portfolio sales, by product ($m), 2015–25

Product 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

2 0 1 5 – 2 5

difference

2 0 1 5 – 2 5

C A G R

Note:totals may not sum due to rounding.

CAGR= compound annual growth rate



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LUNDBECK WILL MAINTAIN ITS POSITION IN THE DEPRESSION MARKET WITH BRINTELLIX

In order to offset the sales decline and maintain its position in the depression market, Lundbeck isaiming to extend its lifecycle management strategy by switching patients from Lexapro onto its noveldepression drug Brintellix (vortioxetine). Brintellix’s multimodal mechanism provides it with a robustantidepressant effect, as well as a very competitive tolerability profile. The drug is forecast to add$688m revenues to the current revenues by 2025 as it faces generic competition in the US fromOctober 2022, upon the drug’s patent expiry. Brintellix is expected to retain market exclusivity inJapan and the five major EU markets through the forecast period. In October 2013, Brintellix wasapproved for the treatment of major depressive disorder by the US Food and Drug Administration(FDA) (Lundbeck, 2013a), while it was given a positive recommendation by the European MedicinesAgency in December 2013 (Lundbeck, 2013b).

Brintellix has a broad label suggesting a strong efficacy profile and good tolerability, althoughcomparator drugs used in its pivotal trials consistently yielded superior antidepressant data. Three ofBrintellix’s registration studies used Cymbalta (duloxetine; Eli Lilly/Shionogi) in an active referencearm, primarily to validate the trial design. While the sample sizes involved did not necessarily allowfor direct head-to-head comparisons, it is difficult to dismiss that Cymbalta outperformed Brintellix inall three studies in the reduction of depression symptoms. Furthermore, in the venlafaxine-referencedstudy, Brintellix also produced an inferior antidepressant effect over the six-week treatment period.

Lundbeck and Takeda have demonstrated a pro-cognitive effect for the drug, which is unique amongcurrent antidepressants. In March 2015, the European Medicines Agency (EMA) approved the additionof this benefit to Brintellix’s label, allowing Brintellix to address a common symptom of depressionthat is commonly overlooked and for which there are no other specific treatment options (Lundbeck,2015a). Contrary to the EMA’s positive response, the US Food and Drug Administration (FDA) rejectedthe label expansion, requesting new data before further consideration (Lundbeck, 2016a). The FDA’snegative response not only highlights differences in regulatory agencies’ assessment of clinical data,but will also likely limit Brintellix from reaching its full commercial potential in the US.

Brintellix is a multimodal serotonergic enhancer with activity at the serotonin receptors 5-HT3, 5-HT7,5-HT1A, and 5-HT1B, and also at the serotonin transporter (Adell, 2010). Lundbeck states thatBrintellix’s pharmacological profile is different from other antidepressants because it increasesserotonin levels at low 5-HT transporter occupancy (occupancy rate of 40% compared to 80% forother antidepressants). The company also points out that Brintellix is a general monoamine enhancer,increasing levels of acetylcholine, norepinephrine, dopamine, and serotonin in regions key for moodregulation (Lundbeck, 2009). LUNDBECK BOOSTS PRESENCE IN THE CNS SEGMENT THROUGH PARTNERSHIP WITH OTSUKA ASABILIFY MAINTENA DRIVES GROWTH

In November 2011, Lundbeck and Otsuka entered into an agreement to develop and commercialize upto five products in the psychiatry field, including Abilify Maintena (aripiprazole), Rexulti(brexpiprazole), and idalopirdine (Lu AE58054) (Lundbeck, 2011). Follow on Abilify Maintena’s launchis one of Otsuka and Lundbeck’s strategies to fight the declining sales of the off-patent Abilify. The


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companies should promote switching from the oral to the long-acting injectable (LAI) formulation byhighlighting the LAI’s potential to improve compliance rates and overall treatment outcomes. Thecompanies will also aim to receive a label expansion for bipolar disorder and expected to launch inJune 2018 in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK).

The antipsychotic Abilify marketed by Otsuka and Bristol-Myers Squibb as an oral, immediate-releasedrug saw patent protection expire in Q2 2015 in the US and Europe. As part of a lifecyclemanagement strategy, Otsuka partnered with Lundbeck to develop a long-acting version of the drug,Abilify Maintena, as an intramuscular depot formulation of aripiprazole administered once every fourweeks. The key advantage of Abilify Maintena over the oral formulations is its ability to improvepatient compliance, as this is a major issue with schizophrenia patients. The launch of AbilifyMaintena in 2013 came at an opportune time, two years prior to Abilify’s patent expiry, therebyproviding a sizable timeframe during which to switch patients to the new formulation.

Although Abilify Maintena benefits from the extensive experience of Otsuka and Lundbeck and astrong patient base inherited from oral Abilify, the new formulation has already encounteredchallenges. Partly due to a complete response letter from the FDA in July 2012 (Lundbeck, 2012a),Abilify Maintena has faced a delay in its US launch, being positioned as the fourth depot in theatypical antipsychotic market behind Risperdal Consta (risperidone; Johnson & Johnson), ZyprexaRelprevv (olanzapine; Eli Lilly), and Invega Sustenna (paliperidone palmitate; Johnson & Johnson).Abilify Maintena possesses a superior tolerability profile, demonstrating decreased weight gain andreduced incidence of hyperlipidemia and hyperglycemia. This will help differentiate the product fromits competitors, and provide a competitive advantage when physicians are considering the needs ofpatients in long-term treatment strategies (Lundbeck, 2012b). A LACK OF A CLEAR COMPETITIVE EDGE WILL LIMIT THE REXULTI’S MARKET PENETRATION

Rexulti (brexpiprazole) is Lundbeck's and Otsuka’s follow-on offering in the schizophrenia market,after being US approved for both schizophrenia and major depressive disorder in July 2015.Datamonitor Healthcare anticipates Rexulti will gain market share from well-establishedantipsychotics and their generics, given its benign side-effect profile. Otsuka/Lundbeck’s strongmarketing efforts are expected to further promote uptake. Rexulti launched in the US in August 2015.Otsuka/Lundbeck have announced plans to file for approval in ex-US markets in the second half of2016. Datamonitor Healthcare therefore assumes Rexulti will launch in the remaining markets of theforecast approximately one year later, in July 2017.

Datamonitor Healthcare expects Rexulti to fall short of Ability in the schizophrenia market due to alack of improved efficacy. Apart from its improved tolerability over Abilify, Rexulti lacks features todistinguish it in the saturated schizophrenia market. There is a wide variety of approved atypicalantipsychotics across the US, EU, and Japan. While they vary slightly in terms of their efficacy andside-effect profile, most result from marginal changes of well-known mechanisms, and as such canhardly be considered groundbreaking therapies. In addition, many of these drugs are either off-patent,or will lose exclusivity in the near future. Rexulti will struggle in a market dominated by well-established brands and their generics, and generic aripiprazole is expected to be a fierce competitor,


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given its similar clinical profile and much lower price point.

Rexulti is an oral dopamine partial agonist that interacts with D1, D3, 5HT1A, sigma 1a and 5HT2Areceptors. In 2013, Lundbeck initiated two Phase III trials of Rexulti in patients with agitationassociated Alzheimer’s disease. The two studies are expected to recruit around 420 and 230 patientsrespectively (NCT01862640, NCT01922258) and to finalize in the second half of 2017. The FDA hasgranted fast-track designation for this programme (Lundbeck, 2016b). LUNDBECK STRENGTHENS ALZHEIMER’S DISEASE MARKET INFLUENCE WITH IDALOPIRDINE

Lundbeck will maintain its longstanding presence in the Alzheimer’s disease market with idalopirdine.Following positive Phase II data in moderate Alzheimer’s disease, Lundbeck joined forces with Otsukaand quickly transitioned idalopirdine into Phase III trials. While a Phase III study of idalopirdine’scompetitor RVT-101 (Axovant Sciences) was recently launched, idalopirdine is well ahead in itsdevelopment, ensuring that it would enjoy first-to-market status should its pivotal clinical trials provesuccessful.

As a 5-hydroxytryptamine-6 (5-HT6) receptor antagonist, idalopirdine is unlikely to have any effect onthe underlying pathology of Alzheimer’s disease. However, it would represent an entirely novel class ofdrugs, and any symptomatic benefit above and beyond existing treatments would be very wellreceived in the market. With Lundbeck’s EU presence and Otsuka’s geographic reach, the companiesare well placed to capitalize on idalopirdine’s novel mechanism.

Lundbeck has a longstanding presence in the Alzheimer’s disease market, having in-licensed Namenda(memantine) from Merz in 2000. Namenda has been very successful for Lundbeck and it representedthe company’s second highest revenue stream until 2013, when the drug lost exclusivity (Lundbeck,2015b). As a result of this experience, Lundbeck would be able to leverage its existing relationshipswith physicians and payers to successfully commercialize and market idalopirdine in the five major EUmarkets (France, Germany, Italy, Spain, and the UK). Bibliography

Adell A (2010) Lu-AA21004, a multimodal serotonergic agent, for the potential treatment ofdepression and anxiety. IDrugs, 13(12), 900–10 <PMID>21154150</PMID>.

Lundbeck (2009) Update on Lu AA21004 clinical development programme in major depressive disorder( M D D ) . A v a i l a b l e f r o m :http://www.lundbeck.com/investor/releases/ReleaseDetai ls/Release_1320878_EN.asp

Lundbeck (2011) Lundbeck and Otsuka Pharmaceutical sign historic agreement to deliver innovativem e d i c i n e s t a r g e t i n g p s y c h i a t r i c d i s o r d e r s w o r l d w i d e . A v a i l a b l e f r o m :http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=622993 [Accessed 19 May 2016].

Lundbeck (2012a) Otsuka receives complete response letter for extended-release injectable suspensionof aripiprazole. Available from: http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=696052


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[Accessed 19 May 2016].

Lundbeck (2012b) Results from a clinical phase III study of once-monthly aripiprazole IM depotformulation for the maintenance treatment of schizophrenia presented at APA. Available from:http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=670921 [Accessed 19 May 2016].

Lundbeck (2013a) Takeda and Lundbeck announce FDA approval of Brintellix (vortioxetine) fort r e a t m e n t o f a d u l t s w i t h m a j o r d e p r e s s i v e d i s o r d e r . A v a i l a b l e f r o m :http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=794050 [Accessed 19 May 2016].

Lundbeck (2013b) Lundbeck receives positive opinion for approval of Brintellix (vortioxetine) in theEuropean Union. Available from: http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=800397[Accessed 19 May 2016].

Lundbeck (2015a) European CHMP issues positive opinion for a label update of Brintellix®(vortioxetine) to reflect its effect on certain aspects of cognitive function in patients with depression.Available from: http://investor.lundbeck.com/releasedetail.cfm?releaseid=900074 [Accessed 19 May2016].

Lundbeck (2015b) Financial Overview. Available from: http://investor.lundbeck.com/financials.cfm [Accessed 18 November 2015].

Lundbeck (2016a) Lundbeck and Takeda receive Complete Response Letter by the FDA for Brintellix®(vortioxetine) sNDA. Available from:http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=962374 [Accessed 19 May 2016].

Lundbeck (2016b) Solid sales performance in 2015 and return to profitability in 2016. Available from:http://files.shareholder.com/downloads/AMDA-GGC00/1877167861x0x874216/37253D76-8571-4DA6-857F-3C0211F207E8/Q42015_Corporate_Release.pdf [Accessed 19 May 2016].

Documents

Lundbeck Company Analysis - Report Store · follow-up Lexapro/Cipralex (escitalopram). However, given Lexapro’s May 2014 patent expiry in Europe, Lundbeck is aiming to maintain