UCB's strong performance enables continued investment into future growth drivers - October 2019
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UCB’s strong performance enables continued investment into future growth drivers October 2019
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Disclaimer and safe harbor
Forward-looking statements
This presentation contains forward-looking statements, including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”,
“plans”, “seeks”, “estimates”, “may”, “will”, and “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs
of management. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks,
uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially
different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this presentation.
Important factors that could result in such differences include but are not limited to: changes in general economic, business and competitive conditions, the inability to
obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in
the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims,
competition from other products including biosimilars, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange
rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. There is no guarantee that new
product candidates will be discovered or identified, nor that such product candidates in the pipeline will progress to product approval or that new indications for existing
products will be developed and approved. Preclinical results also do not guarantee safe and effective performance of product candidates in humans. Products or
potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may not be as
safe or effective as UCB believed at the time of entering into such relationship. Also, UCB or others could discover safety, side effects or manufacturing problems with
its products after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products
may have a material adverse effect on sales of the affected products. Moreover, sales may be impacted by international and domestic trends toward managed care
and health care cost containment, including pricing pressure, political and public scrutiny and the reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and reimbursement. Finally, a breakdown, cyberattack or information security breach could compromise the
confidentiality, integrity and availability of UCB’s data and systems.
Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made
only as of the date of this presentation. UCB expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect any
change in its expectations with regard thereto or any change in events, conditions, for circumstances on which any such statement is based, unless such statement is
required pursuant to applicable laws and regulations.
In the event of any differences between this Presentation and the Annual or Half Year Report, the information included in the Report shall prevail.
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UCB is progressing on its strategic growth path
2019 achievements
Maximize number of lives we can impact positively
Double digit growth for Cimzia® & Vimpat®
Breakthrough &
Lead Bring differentiated drugs faster to patients
2022 Evenity® launch (U.S., Japan, Australia, Canada, & South Korea)
Cimzia® launch in non-radiographic axial spondyloarthritis (U.S.)
Accelerate & Nayzilam® nasal spray approval in acute repetitive seizures (U.S.)
Expand Enhance clinical development cycle times
2019 bimekizumab first positive Phase 3 trial in psoriasis (1 out of 3)
Grow & bimekizumab Phase 3 program start in PsA & axSpA
Prepare padsevonil Phase 3 program start in drug-resistant epilepsy
2015 rozanolixizumab Phase 3 start in MG & proof of concept in CIDP
Invest in innovation
Agreement to acquire Ra Pharmaceuticals*
rEBITDA / revenue ratio of 31% in 2022*
PsA: psoriatic arthritis / axSpA: axial spondyloarthritis MG: myasthenia gravis / CIDP: Chronic Inflammatory Demyelinating Polyneuropathy
* The acquisition is subject to anti-trust clearance & should be completed by the end of Q1 2020. The acquisition of Ra Pharma will not impact UCB’s 2019 financial guidance. The acquisition would be dilutive to UCB’s
mid-term earnings level due to additional planned R&D investments. As a result, the mid-term target of UCB reaching a REBITDA ratio (to revenue) of 31% would move to 2022 from 2021 as previously guided.
4
Maximize number of lives we can impact positively
Cimzia® sustainable growth through new patient populations &
differentiated value proposition
Net sales per region Net sales per indication
PsO
3% CD
11%
EU U.S.
27%
+8% CER
PFS HY 2019 net sales
34%
PsA
€ 782 million 20% RA
Int'l 53%
Markets
+15%; +10% CER
+32% 12% U.S.
CER LYO axSpA
27% U.S. 13%
+8% CER
Growth driven by new indications & women of child bearing age (WOCBA)
PFS: pre-filled syringe
LYO: lyophilized formulation
CER = constant exchange rate
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6 potential product launches by 2025
Higher R&D investments into UCB's rich pipeline
Launch (U.S., Japan, Australia, Canada
& South Korea)
Evenity® • post fracture osteoporosis
CHMP positive opinion (EU – Oct 2019)
Under review in other markets
• acute repetitive epilepsy Approval (U.S.)
Nayzilam® seizures Launch planned in the coming months
• psoriasis (PsO) • First positive Phase 3 trial (Oct 2019)
bimekizumab • psoriatic arthritis (PsA) • Phase 3 started, results end of 2021
Creating value • axial spondyloarthritis (axSpA) • Phase 3 started, results end of 2021
for patients • Phase 2b topline results H1 2020
padsevonil • drug-resistant epilepsy
• Phase 3 topline results H2 2021
• myasthenia gravis (MG) • Phase 3 started, results H1 2021
rozanolixizumab • immune thrombocytopenia (ITP) • Phase 3 to start Q4 2019
• CIDP • Phase 2a started, results H1 2021
• Phase 1 results
UCB0107 • progressive supranuclear palsy
• Next Phase to start Q2 2020
CIDP: chronic inflammatory demyelinating polyneuropathy
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Evolving understanding of overlapping disease highlights
bimekizumab relevance
Psoriatic diseases Psoriatic Spondyloarthritis
arthritis
~30% patients living with ~40% patients living with
~1 % of population
psoriasis progress to psoriatic arthritis have
psoriatic arthritis Psoriasis axial disease
~40% patients living with ~3% - ~5%
psoriatic arthritis have population
moderate to severe
psoriasis Axial
spondyloarthritis
~0.5% - ~1.4%
population
Axial spondyloarthritis market is similar in size to rheumatoid arthritis
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Focusing on markets with strong growth potential
Psoriasis Psoriatic arthritis Axial Spondyloarthritis
$ 23 billion
EU5
4
$ 13 billion
EU5
2 U.S. $ 8 billion $ 6 billion
$ 5 billion $ 4 billion
19
U.S. EU5 EU5 EU5
EU5 2 1 1
11 U.S.
1 U.S. U.S. U.S.
4 6 3 5
2017 2027 2017 2027 2017 2027
8% 9% 8% 3%
16% 15% 12%
5%
23% 29% 54%
10% 83% 48% 85%
38%
21%
40%
22% 25% 5% 20% 6%
2017 2027
2017 2027 2017 2027
IL-17 A / IL-17 A/F TNF-alpha IL-12/23 IL-23 JAK NSAIDs Other mode of action
Decision Resources - Psoriasis | Landscape & Forecast – November 2018
Decision Resources – Psoriatic arthritis | Landscape & Forecast – November 2018
Decision Resources – Axial spondyloarthritis | Landscape & Forecast – June 2019
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Translating scientific hypotheses into clinical development
Available to
Phase 1 Phase 2 Phase 3 Filing patients
Evenity® (romosozumab)
post fracture osteoporosis Partner: Amgen Japan & U.S.
Nayzilam® (midazolam nasal spray)
acute repetitive seizures Approval (U.S.)
bimekizumab (IL17A/F)
psoriasis Topline results Q4 2019
psoriatic arthritis Topline results end 2021
axial spondyloarthritis Topline results end 2021
padsevonil (PPSI)
drug-resistant epilepsy Topline results H2 2021
drug-resistant epilepsy Topline results H1 2020
rozanolixizumab (FcRn)
myasthenia gravis Topline results H1 2021
immune thrombocytopenia Confirmatory phase to start Q4 2019
CIDP Topline results H1 2021
Bone
dapirolizumab pegol (CD40L)
systemic lupus erythematosus Partner: Biogen Phase 3 to start H1 2020 Immunology
UCB0107 Next Phase to start Q2 2020
Neurology
UCB0599 / UCB7858
CIDP: Chronic Inflammatory Demyelinating Polyneuropathy
UCB0159 terminated
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Ra Pharma – Excellent strategic fit with UCB
Enriching our pipeline, adding new patient populations
•
Acquiring novel, potential best-in-class C5 targeting
molecule – 50x smaller than comparable antibody
• Addressing significant unmet medical need in gMG,
IMNM, ALS and other disorders
Creating value
• Highly complementary with rozanolixizumab to support
for patients patients across their individual journey through
moderate/severe chronic and acute settings
• Long term innovation acceleration with addition of
proprietary ExtremeDiversity™ macrocyclic peptide
chemistry platform
gMG : generalized myasthenia gravis The acquisition is subject to anti-trust clearance & should be completed by the end of Q1 2020.
IMNM: immune-mediated necrotizing myopathy
ALS: amyotrophic lateral sclerosis.
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UCB is progressing on its strategic growth path
Executing on the "Accelerate & Expand" phase
Enriching our pipeline, Adding external opportunities
Strategic missions => Ra Pharma acquisition
• Strive for leadership in specific • Lead in myasthenia gravis
patient populations (C5 & anti FcRn)
• Mitigate patent expirations • Accelerated top and bottom line
growth after 2024
• Strengthen pipeline diversity • Zilucoplan: ‘Pipeline in a product’
• Sustain innovation • Technology platform
ExtremeDiversityTM
The acquisition is subject to anti-trust clearance & should be completed by the end of Q1 2020.11
2019 and mid-term guidance
Confirmed
2019 financial targets Mid-term guidance updated*
Revenue € 4.6 - 4.7 billion rEBITDA / revenue ratio of 31% in 2022*
• Continued strong core product growth UCB investing into the pipeline complemented
with inorganic growth opportunities
rEBITDA 27 – 29% of revenue Peak sales
• R&D expense ratio of ~27% (+/-1% point) • Neupro® ~ current (2018) level
Core EPS € 4.40 – 4.80 • Vimpat® > € 1.4 billion by 2022
• Tax ratio of ~20%
• Cimzia® > € 1.7 billion by 2024
• Briviact® > € 600 million by 2026
rEBITDA: recurring Earnings Before Interest, Taxes, Depreciation and Amortization charge
* The acquisition is subject to anti-trust clearance & should be completed by the end of Q1 2020. The acquisition of Ra Pharma will not impact UCB’s 2019 financial guidance. The acquisition would be dilutive to UCB’s
mid-term earnings level due to additional planned R&D investments. As a result, the mid-term target of UCB reaching a REBITDA ratio (to revenue) of 31% would move to 2022 from 2021 as previously guided.12
6 potential product launches in 5 years
Creating value for patients
living with
post fracture osteoporosis
acute repetitive epilepsy
seizures
psoriasis, psoriatic arthritis,
axial spondyloarthritis
ITP, MG, CIDP
drug-resistant epilepsy
progressive supranuclear palsy
ITP: Immune ThrombocytoPenia
MG: Myasthenia Gravis
CIDP: Chronic Inflammatory Demyelinating PolyneuropathyFurther facts and figures
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UCB Story – since 1928
Continuous adaptation to the changing ecosystem
1928
2004 Focus on biopharmaceuticals,
a combination of large, antibody based • Evenity® (U.S., Japan &
molecules and small, chemically-derived molecules
more)
Acquisition of Celltech Group Ltd,
a leading British biotechnology
80’s company 2008 • Cimzia® nr axSpA (U.S.)
Globalization Divestiture of non-core business, • Nayzilam® nasal spray
starting with the films and chemical
Emmanuel Janssen with acquisitions in the
divisions, followed by primary (U.S.)
Union
established U.S., Korea, Thailand
care products 2019
Chimique Belge Stronger focus on and Japan
(UCB) in Brussels research, resulting in the
(Belgium), primarily discovery in 1954 of one of the
focusing on industrial world’s first tranquillizers, Atarax®
chemicals
1987 2006 2016
Production primary care 1970’s - Development of
Acquisition of Schwarz Pharma AG,
products (calcium, a European network 2000 based in Germany, bringing
vitamins, insuline, etc.) through acquisitions in
France, Germany, Italy, complementary therapeutic and
during World War II
Spain and the U.K. geographic focus
The timeline is not proportionated.
Evenity® is the trade name of romosozumab which has been provisionally approved by the European Medicines Agency (EMA)
nr axSpA: non-radiographic axial spondyloarthritis15
UCB's patient value strategy We are UCB
Sustainable company growth - Superior
We are 7 495 employees focused
shareholder value
on creating value for patients
Our ambition is to be the
We bring Cimzia®, Vimpat®,
patient preferred biopharma Keppra®, Briviact® & Neupro®
leader, creating patient value for to more than
specific populations through unique 3 340 000 patients
outcomes, the best experience
Focused on R&D:
and improving as many of these We invest more than
lives as possible. 20% of revenue in R&D –
above industry average
We want to be present and impact
specific patient populations by We commit to reducing our
2025. ecological footprint
We reached in 2018
€ 4.6 billion revenue
€ 1.4 billion recurring EBITDA,
both growing for the 5th year in
a row16
Grow core products
Key information
Cimzia® Vimpat® Keppra® Briviact® Neupro®
• Crohn’s disease Epilepsy POS • Epilepsy POS Epilepsy POS • Parkinson’s
• Rheumatoid arthritis • Adj. therapy • Epilepsy PGTCS • Adj. therapy disease
• Psoriatic arthritis • Monotherapy • Epilepsy myoclonic • Monotherapy (U.S.) • Restless legs
• Pediatric • Pediatric (2018)
• Axial spondyloarthritis seizures syndrome
• Psoriasis (2018)
• WOCBA label update (2018)
> 121 000 patients, > 591 000 patients, ≈ 2.2 million > 82 000 patients, > 366 000 patients,
across 56 countries across 52 countries patients, across 28 countries across 43 countries
across the world
Astellas (Japan - 2012) Daiichi Sankyo Otsuka Otsuka
Cinkate (China – 2019) (Japan - 2014) (Japan – 2008- 2020) (Japan – 2002)
2024 (U.S. & EU) 2022 (U.S. & EU) 2008 (U.S.) 2026 (U.S. & EU) 2021 (U.S. & EU)
2026 (Japan) 2024 (Japan) 2010 (EU) 2024 (Japan)
2020 (Japan) 2030 Several
reformulation patents
(U.S. & EU)
WOCBA: women of child bearing age
POS: partial onset seizures, also known as focal seizures
PGTCS: primary generalized tonic-clonic seizures17
Grow core products
Lifecycle management
Cimzia® Vimpat® Keppra® Briviact® Neupro®
• Nr axSpA • Epilepsy POS pediatric
(U.S. – March) (incl. dry syrup formulation -
• Rheumatoid arthritis Japan - Jan)
(China - July)
• Psoriasis / psoriatic • Epilepsy POS (China): • Epilepsy
arthritis (Japan – Jan) o pediatric (incl. oral monotherapy
formulation – Sept 2018) (U.S. – Feb)
o IV formulation (Sept
2018)
• PGTCS: Positive Phase 3
results (July 2019)
Nr axSpA: non radiographic axial spondyloarthritis
POS: partial onset seizures, also known as focal seizures
PGTCS: primary generalized tonic-clonic seizures18
Cimzia®
Driven by new patient populations: women of child
bearing age and people living with psoriasis
Net sales1 H1 2019 / H1 2018
2019
€ million 2015 FY 2016 FY 2017 FY 2018 FY Act CER
6 months
For patients (including women
of child bearing age) living with U.S. 713 846 918 896 480 15% 8%
• Rheumatoid arthritis
Europe 296 339 370 400 208 8% 8%
• Psoriatic arthritis
• Psoriasis International markets 74 118 136 150 94 31% 32%
• Axial spondyloarthritis
Total Cimzia® 1 083 1 304 1 424 1 446 782 15% 10%
• Crohn’s disease
2019 2024 2026
Psoriasis / psoriatic arthritis: • Loss of exclusivity • Loss of exclusivity
filing (Japan) (U.S. & EU) (Japan)
Nr axial spondyloarthritis²:
approval (U.S.)
Rheumatoid arthritis:
approval (China)
1 Numbers may not add due to rounding 2 nr axSpA: non-radiographic axial spondyloarthritis
CER: constant exchange rates19
Cimzia® in-market performance
U.S. Europe Japan
Cimzia® vs. Rheumatology Cimzia® vs. Rheumatology Cimzia® vs. RA Market
Market Growth 1 Market Growth 1 Growth 1
10%
10% 10%
8.0% 8%
8% 8%
6.4%
6%
5.6% 6% 4.9% 6% +3.0%
5.0%
4% 4% 4% 2.7%
+6.6% -1.5%
2% 2% 2% 0.8%
-0.3%
0% -1.0% 0% 0%
-2% Anti TNF Biologics Cimzia® -2% Anti TNF Biologics Cimzia® Anti TNF Biologics Cimzia®
-2%
Cimzia® Rheumatology Cimzia® Rheumatology Cimzia® RA
7.5% R3M Patient Share 2 9.0%
R3M Patient Share 2 5.0% R3M Patient Share 2
7.0%
7.0% 8.5%
8.0% 4.5% 4.3%
+0.5%
6.5% 8.0% 4.0% 0.0%
-0.2%
6.0% 7.5% 3.5%
Apr-18 Jul-18 Oct-18 Jan-19 Apr-19 May-18 Aug-18 Nov-18 Feb-19 May-19 Dec-17 Mar-18 Jun-18 Sep-18 Dec-18
Source: IMS MIDAS Source: IMS MIDAS; Cimzia® patients are considered 100% in RA
Source: U.S: IQVIA Source of Business Report In-Market KPI’s are based on Exit Patients In-Market KPI’s are based on Exit Patients
1 In-market growth is calculated for MAT period: Europe & Japan : MAT May 2019 vs MAT May 2018 | U.S.: MAT April 2019 vs. MAT April 2018 (patients, all channels)
2 Market share is calculated for R3M period20
Vimpat®
Strong, sustainable growth in all markets
Net sales1 H1 2019 / H1 2018
2019
€ million 2015 FY 2016 FY 2017 FY 2018 FY Act CER
6 months
For patients living with U.S. 513 629 746 822 472 22% 14%
• Epilepsy – POS2
Europe 134 152 177 206 111 11% 11%
• Adults, adolescents and
children from 4 years of International markets 32 42 53 70 39 10% 6%
age (EU, U.S. & Japan)
Total Vimpat® 679 822 976 1 099 622 19% 13%
2019 2022 2024
POS2 pediatric: • Patent expiry • Loss of exclusivity
approval (Japan) (U.S. & EU) (Japan)
PGTCS3:
positive Phase 3 results
1 Numbers may not add due to rounding 2 POS: Partial-onset seizures, also known as focal seizures
CER: constant exchange rate 3 PGTCS: Primary Generalized Tonic-Clonic Seizures21
Vimpat® in-market performance
U.S. Europe Japan
95% Vimpat® vs. AED Market Growth (TDx)
Vimpat® vs. AED Market Growth (TRx) Vimpat® vs. AED Market Growth (TDx) 91.0%
20% 20%
90%
16.6%
15% 15%
+7.5% 85%
8.7% 10% +87%
10% 10%
+18.0%
5% 5% 5%
4.0%
-1.4%
1.2%
0% 0%
0%
AED Market Vimpat® AED Market Vimpat® AED Market Vimpat®
-5% -5%
Vimpat® – R3M TDx Share Vimpat® – R3M TDx Share
5.0% Vimpat® – R3M TRx Share 5.0% 3.0%
4.3% 2.4%
4.5% 4.5% 2.5%
4.1%
4.0% 4.0% 2.0%
3.5% +0.3% 3.5% +0.4% 1.5% +0.6%
3.0% 3.0% 1.0%
May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx Source data EU: IMS MIDAS - In-Market KPI’s are based on TDx Source data JP: IMS MIDAS - In-market KPI’s are based on TDx
AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In Europe and Japan, the TDx of all these molecules
are factored for epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage.22
Keppra®
Mature, established brand
Net sales1
H1 2019 / H1 2018
2019
€ million 2015 FY 2016 FY 2017 FY 2018 FY Act CER
6 months
For patients living with
U.S. 254 216 232 221 103 4% -3%
• Epilepsy – POS
• Epilepsy – PGTCS Europe 250 237 235 216 84 -26% -26%
• Epilepsy myoclonic
seizures
International markets 233 267 311 352 184 2% 1%
Total Keppra® 737 720 778 790 371 -5% -8%
2019 2020
Epilepsy monotherapy: • Loss of exclusivity
filing (U.S.) (Japan)
1 Numbers may not add due to rounding POS: Partial-onset seizures, also known as focal seizures
CER: constant exchange rate PGTCS: Primary Generalized Tonic-Clonic Seizures23
Keppra® in-market performance
U.S. Europe Japan
Keppra® vs. AED Market Growth (TRx) Keppra® vs. AED Market Growth (TDx) Keppra® vs. AED Market Growth (TDx)
5% 5% 25%
1.2%
20% 18.7%
0% 0%
15%
-5% -11.5% -5%
-1.4%
+14.7%
-3.9% 10%
-10% -10% -2.5% 4.0%
5%
-10.3%
-15% -15% 0%
AED Market Keppra® AED Market Keppra® AED Market Keppra®
Keppra® – R3M TDx Share Keppra® – R3M TDx Share
2.5% Keppra® – R3M TRx Share 13.5% 20.0% 19.4%
2.0% 13.0% 19.0%
1.5% 12.5% 12.1% 18.0%
1.0% 0.6% 12.0% 17.0%
-0.3% +3.3%
0.5% 11.5% 16.0%
0.0% 11.0% 15.0%
May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx Source data EU: IMS MIDAS - In-Market KPI’s are based on TDx Source data JP: IMS MIDAS - In-market KPI’s are based on TDx
AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In Europe and Japan, the TDx of all these molecules are
factored for epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage.24
Briviact®
Available to more and more patients
Net sales1
H1 2019 / H1 2018
2019
For patients living with € million 2015 FY 2016 FY 2017 FY 2018 FY Act CER
6 months
• Epilepsy – POS2
U.S. 11 63 109 81 76% 65%
• Adults, adolescents and
children from 4 years of Europe 7 22 29 19 55% 55%
age (EU & U.S.)
International markets 0 1 4 3 > 100% > 100%
®
Total Briviact 18 87 142 103 73% 64%
2021 2026
• Epilepsy POS2 • Patent expiry
Phase 3 results (Japan) (U.S. & EU)
1 Numbers may not add due to rounding 2 POS: Partial-onset seizures, also known as focal seizures
CER: constant exchange rate25
Briviact® in-market performance
A new therapeutic option in the AED market
U.S. Europe
Briviact® – R3M TDx Share
Briviact® – R3M TRx Share 1.00%
1.00% 1.00%
0.80% 0.80%
+0.4%
0.60% 0.60%
0.37%
0.40% 0.40%
0.20% 0.20%
+0.1%
0.00% 0.00%
May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19
Source data U.S.: U.S. IMS NPA Source data EU: IMS MIDAS
In-Market KPIs are based on TRx In-Market KPI’s are based on TDx
AED market: All molecules in ATC3= N3A + Phenobarbital in N5B. In EU, the TDx of all these molecules are factored for
epilepsy usage. In the U.S., the TRx of 26 of these molecules are factored for epilepsy usage.26
Neupro®
At its peak sales and with longer patent live
Net sales1
2019
€ million 2015 FY 2016 FY 2017 FY 2018 FY Act CER
6 months
For people living with
• Parkinson’s disease
U.S. 79 85 96 101 46 13% 5%
• Restless legs syndrome Europe 150 161 168 174 83 -3% -3%
International markets 29 52 50 46 29 36% 31%
Total Neupro® 258 298 314 321 158 7% 4%
2021 2024 2030
• Patent expiry • Patent expiry • Several reformulation
(U.S. & EU) (Japan) patents expiry
(U.S. & EU)
1 Numbers may not add due to rounding
CER: constant exchange rate27
Neupro® in-market performance
U.S. Europe Japan
Neupro® PD vs. PD (KC) Neupro® vs. (KC) Neupro® PD vs. PD (KC)
20% Market Growth (TRx) 20%
Market Growth (TDx) 20% Market Growth (TDx) 16.3%
15% 15% 15%
10% +1.2%
-0.9% 10% 10%
5% +16.4%
0.2% 5% 2.4% 1.1% 2.3% 5%
0% 0.8%
-5% 0% 0%
PD Market PD key Neupro® -0.1%
-10% -5.6% -6.5% -5% -5%
competitors
PD market PD key Neupro® PD Market PD key Neupro®
competitors competitors
Neupro® PD – R3M TDx Share Neupro® PD – R3M TDx Share
10.5% Neupro® PD – R3M TRx Share 16.5% 38.0%
36.8%
16.1%
10.0% 9.8% 16.0% 36.0%
9.5% -0.2% 15.5% +0.2% 34.0% +3.5%
9.0% 15.0% 32.0%
May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19 May-18 Aug-18 Nov-18 Feb-19 May-19
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx Source data EU: IMS MIDAS - In-Market KPI’s are based on TDx Source data JP: IMS MIDAS - In-market KPI’s are based on TDx
PD market: All molecules in ATC3= N4A. In the Europe and Japan, the TDx of all these molecules are factored for PD usage. In the US, only the TRx of Rotigotine, Pramipexole and Ropinirole are factored for PD usage
PD Key Competitors (KC) market: The 8 DA’s (Dopamine Antagonists): Bromocriptine, Cabergoline, Lisuride, Pergolide, Rotigotine, Pramipexole, Piribedil, Ropinirole
In the U.S., only Rotigotine, Pramipexole and Ropinirole are factored for PD usage, hence the PD market and PD KC market are the same.28
Evenity® (romosozumab) in post fracture osteoporosis
An innovative bone-forming therapy under regulatory review
Dual effect on bone: increases bone formation and
decreases bone resorption
Opportunity to build new bone and slow bone loss in
osteoporosis patients at imminent risk of fragility fractures
ARCH, FRAME, BRIDGE and STRUCTURE
• Phase 3 studies completed
Manorama,
living with
osteoporosis
Launch in the U.S., Japan, Australia, Canada & South Korea
• CHMP positive opinion (EU – Oct 2019)
• Under review in other markets
The trademark Evenity™ is provisionally approved for use by the European Medicines Agency (EMA).
Evenity™ (romosozumab) is developed in partnership with Amgen globally.29
Bimekizumab Phase 3 development program in psoriasis
3 trials against active comparators designed to demonstrate
superiority
Phase 3 Phase 3 Phase 3 Phase 3b
BE VIVID / PS0009 BE SURE / PS0008 BE READY / PS0013 BE RADIANT / PS0015
NCT03370133 NCT03412747 NCT03410992 NCT03536884
• 560 patients living with • 450 patients living with • 400 patients living with • 700 patients living with
psoriasis1 psoriasis1 psoriasis1 psoriasis1
Duration • 52 weeks • 56 weeks • 56 weeks • 48 weeks
Comparator • ustekinumab • adalimumab • placebo • secukinumab
• placebo
Primary
endpoints • PASI90 response • PASI90 response • PASI90 response • PASI100 response
@ week 16 • IGA 0/1 response • IGA 0/1 response • IGA 0/1 response
Positive topline results Start Jan. 2018 Start Feb. 2018 Start June 2018
(Oct 2019)
Results: Q4 2019 Results: Q4 2019 Results: Q2 2020
1 moderate to severe chronic plaque psoriasis IGA: Investigator's Global Assessment
PASI90: Patients experiencing at least 90% skin clearance Source: www.clinicaltrial.gov
PASI100: Patients experiencing 100% skin clearance30
Bimekizumab: ambition to deliver best efficacy in skin
Psoriasis Phase 3 trials designed to demonstrate superiority
week 16 20 24 28 32 36 40 44 48 52 56
BE SURE bimekizumab bimekizumab
NCT03412747 bimekizumab bimekizumab
PS0008 adalimumab adalimumab bimekizumab
450 patients
Phase 3 trials
BE VIVID placebo bimekizumab Primary endpoints:
NCT03370133 bimekizumab bimekizumab • PASI90
PS0009 ustekinumab ustekinumab
560 patients
• IGA 0/1
BE READY placebo placebo
bimekizumab
Results Q4 2019
NCT03410992
PS0013 bimekizumab bimekizumab
400 patients placebo
week 16 20 24 28 32 36 40 44 48 Phase 3b trial
BE RADIANT bimekizumab bimekizumab
NCT03536884 Primary endpoint:
bimekizumab
PS0015 • PASI100
700 patients secukinumab secukinumab
Results Q2 2020
Different colors for bimekizumab indicate different dosing regimens
IGA: Investigator's Global Assessment31
Psoriasis affects a significant portion of the population
Prevalence1 Age2,3
Late teens–early Fifties
Age, geographic
thirties (type 2 PSO) region, and ethnicity
(type 1 PSO)
all influence
an individual’s risk
of developing PSO
45% 55% Two peaks of incidence
Ethnicity Geographic region
PSO more commonly Reported prevalence in adults:
up to affects Caucasians than
Japan6 UK4 Brazil7 Italy4 France4 Norway4
3%
other ethnic groups4 USA4
~ Prevalence according to
ethnicity in the USA5 :
Caucasian
American
of the population8
African
is affected by PSO 2.5% 0.34% 0.91% 2.2% 2.5% 3.1% 5.2% 8.5%
1.3%
Prevalence generally increases with increasing distance from the equator2
1. Kimball AB et al. Br J Dermatol. 2014;171(1):137-147. 4. Parisi R et al. J Invest Dermatol. 2013;133(2):377-385. 7. Duarte GV et al. Psoriasis( Auckl). 2015;5:55-64
2. Crow JM. Nature. 2012;492(7429):S50-S51. 5. Enamandram M and Kimball AB. J Invest Dermatol. 2013;133(2):287-289. 8. Parisi R, et al. J Invest Dermatol. 2013;133:377-385.
3. Langley RG et al. Ann Rheum Dis. 2005;64:(suppl 2):ii18-23; discussion ii24-25. 6. Kubota K et al. BMJ Open. 2015 Jan 14;5(1):e006450. UCB CONFIDENTIAL. For restricted/internal communications only.32
Bimekizumab – best in disease efficacy in skin and joints
Phase 3 programs started Q2 2019
Psoriatic arthritis
week 16 52
BE OPTIMAL bimekizumab bimekizumab
NCT03895203 adalimumab adalimumab
Primary endpoint
PA0010 placebo bimekizumab ACR50 @ week 16
840 patients
Results end 2021
BE COMPLETE
NCT03896581 bimekizumab
PA0011 placebo
390 patients
Axial Spondyloarthritis
week 16 52
BE MOBILE1
NCT03928704 bimekizumab bimekizumab
placebo bimekizumab
Primary endpoint
AS0010
ASAS40 @ week 16
240 patients
BE MOBILE2 Results end 2021
NCT03928743 bimekizumab bimekizumab
AS0011 placebo bimekizumab
300 patients
BE MOBILE1: to assess the efficacy, safety and tolerability of bimekizumab versus placebo in patients with active non-radiographic axial spondyloarthritis
BE MOBILE 2: to assess the efficacy, safety and tolerability of bimekizumab versus placebo in patients with active ankylosing spondylitis33
Padsevonil Phase 2 program in drug-resistant focal epilepsy
Patients with high unmet medical need
Phase 2a Phase 2b Phase 3
EP0069 / NCT02495844 ARISE / EP0091 / NCT03373383 DUET / EP0092 / NCT03739840
• 55 patients with highly drug- • 400 patients with drug-resistant • 500 patients with drug-resistant
resistant focal epilepsy focal epilepsy focal epilepsy
• failed with ≥4 AED • failed with ≥ 4 AED • failed with ≥ 4 AED
• experiencing ≥4 seizures / week • experiencing ≥4 seizures / month • experiencing ≥4 seizures / month
Comparator • padsevonil / placebo (2 arms) • padsevonil / placebo (5 arms) • padsevonil / placebo (4 arms)
Endpoints • 75 % responder rate* • Seizure frequency • Seizure frequency
31% padsevonil • from baseline over the 12 week • from baseline over the 12 week
11% placebo maintenance period (U.S., Japan) maintenance period (U.S., Japan)
• 75% responder rate* (EU) • 75% responder rate* (EU)
AES 2017 Topline results H1 2020 Topline results H2 2021
* Proportion of subjects who achieve ≥75 % reduction in focal seizure frequency34
Rozanolixizumab potential in multiple IgG autoantibody-
mediated diseases with high unmet medical need
Myasthenia gravis Immune thrombocytopenia Chronic inflammatory
demyelinating polyneuropathy
Antibodies target components of Antibodies target platelets and Antibodies target components of
neuromuscular junction destroy them peripheral nerves, causing damage to
the myelin sheath and axon
• Muscle weakness (extremities, • Thrombocytopenia • Motor deficits
eyes, bulbar and respiratory • Bleeding (petechiae, purpura, • Sensory deficits
symptoms) nosebleeds, intracranial bleeding)
• Fatigue • Fatigue
~ 10 - 45 cases / 100 000 ~ 10 - 50 cases / 100 000 ~ 1 - 6 cases / 100 000
• Surgery (thymectomy) • Platelet transfusion • IV Steroids
• Steroids, steroid-sparing drugs • IV immunoglobulin (IVIg) • IV / subQ immunoglobulin
• Plasma exchange (PEX) • Steroids • Plasma exchange (PEX)
• IV immunoglobulin (IVIg) • Surgery (splenectomy)
• TPO receptor agonists
Current therapies associated with morbidity and burdensome to patients & healthcare systems
IV: Intravenous
subQ: sub-cutaneous
TPO: thrombopoietin35
Rozanolixizumab, novel targeted approach recycling IgG
Transforming disease control and ecosystem burden
blocks FcRn receptors binding Proof of Confirmatory
plasma IgG concept phase
resulting in the attenuation of IgG recycling,
and thus removal of IgG autoantibodies
myasthenia gravis
(MG) Topline results
H1 2021
patients living with IgG-mediated immune
autoimmune disease thrombocytopenia
(ITP)
Start
Q4 2019
Chronic diseases with unpredictable fluctuations
and high treatment-associated burden (hospital Topline results
CIDP3
setting, invasive) H1 2021
Value proposition:
Providing a patient-focused solution with a quick home SubQ1 delivery
1 SubQ: subcutaneous
2 IgG: Immunoglobulin G
3 Chronic Inflammatory Demyelinating Polyneuropathy36
Rozanolixizumab SubQ treatment for IgG-mediated diseases
Proof of concept established in MG & ITP
Moving to confirmatory phase
CIDP Myasthenia gravis
Immune thrombocytopenia
(NCT03861481) (NCT03971422)
240 patients with moderate to severe MG
34 patients with Chronic
Inflammatory Demyelinating • diagnosis of MG @ screening
Polyneuropathy • be considered for treatment with
immunological therapy
Duration 12 weeks 43 days
Comparator placebo (2 arms) placebo (3 arms)
Endpoints Clinical change from base line Change from baseline in Myasthenia Gravis-
Safety and tolerability Activities of Daily Living (MG-ADL) score to
Visit 10
Phase 2a Confirmatory phase/Phase 3 Confirmatory phase/Phase 3
Topline results H1 2021 Topline results H1 2021 to start Q4 2019
subQ: sub-cutaneous
IgG: immunoglobulin
CIDP: Chronic Inflammatory Demyelinating Polyneuropathy37
Positive Phase 1 - UCB0107, an anti-Tau antibody for
Progressive Supranuclear Palsy & Alzheimer’s disease
Key facts Key insights
UCB0107 blocks tau uptake and
aggregation UCB0107 was generated Tau seeds spread from dying cells
to block spreading of tau to infect other neurons
• Tau misfolding and aggregation
leads to neuronal death and seeds from patient
disease spread materials
AD
• PSP is a rare, rapidly progressing
tauopathy with debilitating PSP
cognitive & motor symptoms
• Alzheimer’s disease is also a Tau seed
tauopathy, with high prevalence
and economic impact
Source: UCB internal data
PSP: Progressive Supranuclear Palsy38
2019 HY financial highlights
Strong product growth and investment into future growth
Actual CER
Revenue € 2 323 million +2% +4%
• Net sales up by 3% (+2% CER) to € 2.2 billion
driven by core products, impacted by hedging and
divestitures
Total operating expenses € 1 154 million +11% +8%
• Marketing & selling expense +14%
Cimzia® launch in psoriasis & nr axSpA
• R&D expense +13% (ratio 24%)
-9% -1%
4 Phase 3 programs started
Recurring EBITDA € 724 million
• rEBITDA/revenue ratio 31%
Profit of the Group € 437 million -24% -14%
• Tax ratio 20%
• € 411 million attributable to UCB shareholders
-22% -12%
Core earnings per share € 2.42
Based on 187 million weighted average shares outstanding
(2018: 188 million)
CER: constant exchange rates
Nr axSpA: non radiographic axial spondyloarthritis39
Strong underlying net sales growth
Strong performance of UCB's blockbusters: Cimzia® and Vimpat®
Act (CER)
Cimzia® € 782 million +15% (+10%)
Driven by new patient populations
Vimpat® € 622 million +19% (+13%)
Strong, sustainable growth in all markets
Keppra® € 371 million -5% (-8%)
2019 HY net sales1
Mature established brand
€ 2 270 million
+9% (+5% CER) Briviact® € 103 million +73% (+64%)
Reaching more and more patients
Neupro® € 158 million +7% (+4%)
Growth in the U.S. and Int’l markets
Established brands € 233 million -17% (-17%)
Impacted by divestitures: adjusted: -0%
CER = constant currency exchange rates
1 Net sales excluding - € 51 million from hedging40 Recurring EBITDA Numbers may not add due to rounding EBIT: Earnings before interest and taxes CER: constant exchange rate EBITDA: Earning before interests, taxes, depreciation and amortization charges
41 Profit Numbers may not add due to rounding CER: constant exchange rate EBIT: Earnings before interest and taxes
42 Core earnings per share Numbers may not add due to rounding CER: constant exchange rate
43 Key product net sales performance Numbers may not add due to rounding CER: constant exchange rate
44
Strong Cash Flows (HY 2019)
Cash flow from continuing operations Net debt
€ million
€ million
CAGR: composite annual growth rate45 Debt maturity schedule (@ 30 June 2019)
46
One UCB today: A global player
Presence in 38 countries
complemented by a robust network of partners
50/50
Women / Men
7 498 564
UCB employees worldwide
New
colleagues
Situation at 30 June 201947
Green strategy @ UCB
UCB environmental commitments by 2030
CO2 emissions -35%
Water consumption -20%
Waste production -25%
More information on https://www.ucb.com/our-company/green-strategy48
Corporate governance
Board of Directors
• 13 members
• Mandate: 4 year
• Age limit: 70
• 5 women (38%)
• 7 independent directors (54%)
• 5 nationalities
● Women ● Men ● Belgium ● France
● U.K. ● U.S.
● Denmark / Sweden
Status post 2019 AGM49
Corporate governance
Executive Committee
• 12 members
• JC Tellier CEO since 2015
• 3 women (23%)
• 6 nationalities
● Women ● Men
● Belgium ● France
● Germany ● Netherlands
● U.K. / South Africa
● U.S.
Status at 30 June 201950
Stable shareholder base with free-float of 62%
Weighted average shares outstanding in 2019: 187 million
“Free float”
by region
Source: Latest notifications, FactSet and UCB underlying ownership analysis (October 2018)51
UCB Investor Relations team
• Antje Witte Check out our IR App &
Vice President Investor Relations
stay tuned to UCB wherever you go!
Phone: +32 2 559 9414
E-mail: antje.witte@ucb.com
• Isabelle Ghellynck
Associate Director Investor Relations
Phone: +32 2 559 9588
E-mail: isabelle.ghellynck@ucb.com
• Nathalie Deldime
Investor Relations Events Manager
Phone: +32 2 559 9291
E-mail: nathalie.deldime@ucb.comYou can also read
