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9M 2018 reportDisclaimer and safe harbor 2
Forward-looking statementsThis 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 andbeliefs 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 materiallydifferent 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 toobtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects forproducts in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patentprotection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration ofsuch laws and hiring and retention of its employees. There is no guarantee that new product candidates in the pipeline will progress to product approval or that newindications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensingcollaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with itsproducts after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containmentand the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are madeonly as of the date of this presentation. UCB expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect anychange in its expectations with regard thereto or any change in events, conditions, for circumstances on which any such statement is based, unless such statement isrequired 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.
9M 2018 reportUCB's patient value strategy 3
Our ambition is to be the patient preferred biotech leader,
creating patient value for specific populations through unique outcomes, the best experience and improving as
many of these lives as possible.
This will lead to sustainable growthfor UCB and its shareholders.
Value for patients
Mariana, living with epilepsy
Value for shareholders
9M 2018 reportDriving value for patients 4
Progress towards higher patient value
From Patient to ScienceCimzia® women of child bearing age approval
UCB0107 (anti-Tau antibody) first in human
From Science to SolutionRozanolixizumab discovery driven by patient experiences with outpatient treatment
From Solution to PatientThanks to innovative extrapolation, faster access for epilepsy patients for Briviact® (pediatric) and Keppra® (China)
Acquisition of midazolam nasal spray in the treatment of acute repetitive seizures (ARS) in patients with epilepsyPartnership with Sciences 37 to bring clinical studies directly into patient’s home
9M 2018 reportUCB is progressing on our strategic growth path 5
Refer to slides in the appendix for further details
Grow core productsCimzia®, Vimpat®, Keppra®, Briviact® + Neupro®
combined net sales: € 2.78 billion (+6%; +12% CER)
Advance and prepare launch of next wavePhase 3 program for bimekizumab in psoriasis startedEvenity™ resubmission to U.S. FDAmidazolam filing (U.S.)
Deliver breakthrough solutionsdapirolizumab pegol Phase 2b topline results in lupusrozanolixizumab Phase 2a topline results in myasthenia gravisUCB0107 (anti-Tau antibody) first in human
Continued focusCreation of Syndesi + investment in CeribellAcquisitions of Element Genomics + midazolam nasal spray
Grow & Prepare
2015
Accelerate & Expand
2019
Breakthrough & Lead
2022
2018 financial outlook confirmed
Achievements 2018 vs. priorities – well on track
9M 2018 reportGrow core products 6
On track to deliver FY 2018 guidance
Numbers may not add due to roundingCER: constant exchange rate
€ million 9M 2018 9M 2017 Act CER
Revenue 3 441 3 331 3% 6%
Immunology 1 052 1022 3% 9%
Cimzia® 1 052 1022 3% 9%
Neurology 1 728 1601 8% 14%Vimpat® 795 707 13% 19%
Keppra® 608 607 0% 5%
Briviact® 97 57 70% 81%
Neupro® 228 230 -1% 2%
Combined net sales:€ 2.78 billion
(+6%; +12% CER)
Adjusted for allergy drugdivestiture: +5%; +8% CER
9M 2018 reportIncreasing value of UCB's early and late-stage pipeline 7
Driven by strong UCB science and technology platforms
dapirolizumabpegol
systemic lupus erythematosus
padsevonilepilepsy
rozanolixizumabmyasthenia gravis
immune thrombocytopenia
UCB7858
UCB6673
UCB0599
Phase 2b / Phase 3
Phase 1
UCB0159
Phase 2a
UCB0107
Seletalisib in Sjogren's Syndrome and APDS (phase 2a and phase 1b) deprioritized UCB4144/VR942 available for license
radiprodilinfantile spasm
Filing
romosozumabosteoporosis
midazolamnasal spray - acute repetitive seizures
neurologyimmunologybone
bimekizumabpsoriasis, psoriatic arthritis
ankylosing spondylitis
9M 2018 reportContinued focus 8
Complement & share
Acquisitions Spin offs
midazolamnasal spray in epilepsy
StrideBio, Inc.
UCB acquired rights to midazolam nasal spray from Proximagen in April 2018UCB invested in Ceribell in September 2018
VenturesInvestment
Rapid Response EEG System
9M 2018 report2018 and mid-term guidance confirmed 9
Maximize (new) growth drivers and strengthen sustainability
rEBITDA: recurring Earnings Before Interest, Taxes, Depreciation and Amortization charge* ~188 million shares weighted average outstanding
2018 financial targets Mid-term guidance
Revenue € 4.5 - 4.6 billion• Continued strong core product growth
• Currency exchange impact
rEBITDA / revenue ratio of 31% in 2021UCB investing into the pipeline complemented with inorganic growth opportunities
rEBITDA € 1.3 – 1.4 billion• R&D expense ratio of ~26% (+/-1% point)
• Launch preparation
Peak sales• 'CVN' combined > € 3.1 billion by 2020
• Briviact® > € 600 million in 2026
Core EPS* € 4.30 – 4.70• Expected underlying tax ratio
in the "low twenties"
9M 2018 reportAdvance and prepare launch of next products 10
Delivering on strategy, growth and profitability targets
The trademark Evenity™ is provisionally approved for use by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Evenity™ (romosozumab) is developed in partnership with Amgen globally.UCB acquired rights to midazolam nasal spray from Proximagen in April 2018
Phase 3 program completed
Regulatory review•U.S. – resubmission of the Biologics License Application (July 2018)
•EU (Jan. 2018)
•CDN, JP, AU, BR, CH
Evenity™(romosozumab)
Phase 2b program completed
Phase 3 • psoriasis: ongoing
(results Q4 2019)
• psoriatic arthritis to start (Q4 2018)
• ankylosing spondylitis to start (Q4 2018)
bimekizumab
Phase 2a program completed
Phase 2b ongoing• highly drug-resistant
epilepsy
• start: Feb. 2018 (results H1 2020)
padsevonil
Acquired: Phase 3 program completed
Regulatory review• U.S. filing (Aug 2018)
• orphan drug + fast track designation granted
midazolamnasal spray
Proof of concept achieved
Phase 2 ongoing• myasthenia gravis
results (Oct 2018)
• immune thrombocytopenia (ITP) (results Q4 2018)
• CIDP to start Q1 2019
rozanolixizumab
Sustainable top and bottom line growth delivered over the last years Profitability target achieved ahead of time in 2017 Strong foundation enabling future growth and investments in innovation
CIDP: Chronic inflammatory demyelinating polyneuropathy
9M 2018 reportGrow core products 12
2018 lifecycle management milestones
WOCBA: women of child bearing age Nr axSpA: non radiographic axial spondyloarthritisPsO: psoriasis PsA: psoriatic arthritisPOS: partial onset seizures, also known as focal seizures GTCS: primary generalized tonic-clonic seizures
Cimzia® Vimpat® Keppra® Briviact® Neupro®
• WOCBA label extension (EU – Jan / U.S. – Mar / Japan – Sept)
• Psoriasis (U.S. – May / EU – June)
• AutoClick® (Japan – Aug)
• Epilepsy GTCS (China – May)
• Epilepsy monotherapy (China – July)
• Epilepsy POS: pediatric (U.S. – May / EU – July)
• Parkinson’s disease (China – July)
• Rheumatoid arthritis (China – Mar)
• Nr axSpA³ (U.S. – Sept)
• Epilepsy POS (Japan): o pediatric (incl. dry syrup
formulation - Jan) o IV formulation (Jan)
• Epilepsy POS (China): o pediatric (incl. oral
formulation - Sept) o IV formulation (Sept)
• Nr axSpA³: Phase 3 results (U.S. – May)
• PsO4 / PsA: Phase 3 results (Japan – Sept)
• Acute repetitive seizures: Phase 2 results (July)
9M 2018 reportCimzia® performance 13
Sustainable growth in all regions
1 Numbers may not add due to rounding 2 nr axSpA: non-radiographic axial spondyloarthritisCER: constant exchange rates
Label extension to include WOCBA (EU / U.S. / Japan) Psoriasis: approval (U.S. & EU) AutoClick®: approval (Japan) Nr axial spondyloarthritis²: Phase 3 results & filing (U.S.) Psoriasis / psoriatic arthritis: Phase 3 results (Japan)
• Loss of exclusivity (U.S. & EU)
• Loss of exclusivity(Japan)
2018 2024 2026
For patients living with• Rheumatoid arthritis• Psoriatic arthritis• Psoriasis• Ankylosing spondylitis /
axial spondyloarthritis• Crohn’s disease
Net sales1
€ million 9 M 2018 9M 2017 Act CER
U.S. 652 656 -1% 7%
Europe 294 271 9% 9%
International markets 106 95 11% 22%
Total Cimzia® 1 052 1 022 3% 9%
9M 2018 reportCimzia® in-market performance 14
1 In-market growth is calculated for MAT period ; US, Europe & Japan : MAT Aug 2018 vs MAT Aug 20172 Market share is calculated for R3M period
6.3%
5.5%
6.0%
6.5%
7.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Cimzia® RheumatologyR3M Patient Share 2
2.6%6.7%
10.0%
0%
5%
10%
15%
20%
Anti TNF Biologics Cimzia®
Cimzia® vs. Rheumatology Market Growth 1
U.S.
+7.4%
+0.3%
Source: U.S: IQVIA Source of Business Report Aug 2018
3.2%6.3%
10.3%
0%
5%
10%
15%
20%
Anti TNF Biologics Cimzia®
Cimzia® vs. RA Market Growth 1
10.4%12.0%
9.1%
0%
5%
10%
15%
20%
Anti TNF Biologics Cimzia®
Cimzia® vs. RheumatologyMarket Growth 1
Europe Japan
8.3%
7.5%
8.0%
8.5%
9.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Cimzia® RheumatologyR3M Patient Share 2
Source: IMS MIDASIn-Market KPI’s are based on Exit Patients
+7.1%
4.4%
3.5%
4.0%
4.5%
5.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Cimzia® RA R3M Patient Share 2
+0.3%
Source: IMS MIDAS; Cimzia® patients are considered 100% in RAIn-Market KPI’s are based on Exit Patients
-1.3%
9M 2018 reportVimpat® 15
Strong growth in all markets
1 Numbers may not add due to rounding 2 POS: Partial-onset seizures, also known as focal seizuresCER: constant exchange rate 3 PGTCS: Primary Generalized Tonic-Clonic Seizures
• PGTCS3: Phase 3 results
• Patent expiry (U.S. & EU)
• Loss of exclusivity(Japan)
2019 20242022
For patients living with• Epilepsy – POS2
• Adults, adolescents and children from 4 years of age (EU & U.S.)
• Adults (Japan)
Net sales1
€ million 9 M 2018 9M 2017 Act CER
U.S. 589 540 9% 17%
Europe 152 128 19% 19%
International markets 54 39 39% 50%
Total Vimpat® 795 707 13% 19%
2018
POS2 pediatric (incl. dry syrup formulation): filing (Japan)
IV formulation: filing (Japan) POS2 pediatric (incl. oral solution):
submission (China) IV formulation: submission (China) U.S. Court of Appeals confirms
validity of patent
9M 2018 report
4.0%
3.0%
3.2%
3.4%
3.6%
3.8%
4.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Vimpat® – R3M TDx Share
4.4%
3.8%
4.0%
4.2%
4.4%
4.6%
4.8%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Vimpat® – R3M TRx Share
1.1%
7.9%
0%
5%
10%
15%
20%
AED Market Vimpat®
Vimpat® vs. AED Market Growth (TRx)
5.6%
0%
5%
10%
AED Market Vimpat®
-2.1%
18.8%
-5%
0%
5%
10%
15%
20%
AED Market Vimpat®
Vimpat® vs. AED Market Growth (TDx)
Vimpat® in-market performance 16
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.
U.S.
+6.8%
+0.3%
Europe Japan
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx
+20.9%
+0.8%
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
2.2%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Vimpat® – R3M TDx Share
+419%
+1.6%
424.9%
420%
425%
430% Vimpat® vs. AED Market Growth (TDx)
9M 2018 reportKeppra® 17
Reflecting both, the established brand and the maturity
1 Numbers may not add due to rounding POS: Partial-onset seizures, also known as focal seizuresCER: constant exchange rate PGTCS: Primary Generalized Tonic-Clonic Seizures
GTCS: Generalized Tonic-Clonic Seizures
• Patent expiry(Japan)
2020
For patients living with• Epilepsy – POS• Epilepsy – PGTCS• Epilepsy myoclonic
seizures
Net sales1
€ million 9M 2018 9M 2017 Act CER
U.S. 168 173 -3% 4%
Europe 168 178 -6% -5%
International markets 272 256 6% 13%
Total Keppra® 608 607 0% 5%
Epilepsy GTCS: approval (China)
Epilepsy monotherapy: approval (China)
2018
9M 2018 report
-2.1% -2.4%
-15%
-10%
-5%
0%AED Market Keppra®
Keppra® vs. AED Market Growth (TDx)
12.2%
11.0%
11.5%
12.0%
12.5%
13.0%
13.5%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Keppra® – R3M TDx Share
0.7%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Keppra® – R3M TRx Share
1.1%
-11.8%-15%
-10%
-5%
0%
5%
AED Market Keppra®
Keppra® vs. AED Market Growth (TRx)
5.6%
20.6%
0%
5%
10%
15%
20%
25%
AED Market Keppra®
Keppra® vs. AED Market Growth (TDx)
Keppra® in-market performance 18
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.
U.S.
-12.9%
-0.1%
Europe Japan
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx
-0.3%
-0.3%
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
16.6%
14.5%
15.0%
15.5%
16.0%
16.5%
17.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Keppra® – R3M TDx Share
+15%
+1.6%
9M 2018 reportBriviact® 19
Strong U.S. growth
1 Numbers may not add due to rounding 2 POS: Partial-onset seizures, also known as focal seizuresCER: constant exchange rate Acute repetitive seizures study NCT03021018
• Epilepsy POS2
Phase 3 results (Japan)
2021
For patients living with• Epilepsy – POS2
• Adults, adolescents and children from 4 years of age (EU & U.S.)
Net sales1
• Patent expiry (U.S. & EU)
€ million 9M 2018 9M 2017 Act CER
U.S. 75 40 85% 99%Europe 20 16 27% 28%International markets 2 1 > 100% > 100%Total Briviact® 97 57 70% 81%
20262018
POS2: pediatric approval (U.S. & EU)
Acute repetitive seizures: Phase 2 results
9M 2018 reportBriviact® in-market performance 20
A new therapeutic option in the AED market
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.
U.S. Europe
Source data U.S.: U.S. IMS NPAIn-Market KPIs are based on TRx
Source data EU: IMS MIDASIn-Market KPI’s are based on TDx
0.33%
0.00%
0.20%
0.40%
0.60%
0.80%
1.00%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Briviact® – R3M TRx Share
0.72%
0.00%
0.20%
0.40%
0.60%
0.80%
1.00%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Briviact® – R3M TDx Share
+0.1%
+0.3%
9M 2018 reportNeupro® 21
Stable at constant exchange rates
1 Numbers may not add due to rounding CER: constant exchange rate
For patients living with• Parkinson’s disease• Restless legs syndrome
Net sales1
• Patent expiry (Japan)
2024
€ million 9M 2018 9M 2017 Act CER
U.S. 68 72 -6% 1%
Europe 127 122 4% 5%
International markets 33 35 -7% -2%
Total Neupro® 228 230 -1% 2%
• Patent expiry (U.S. & EU)
20212018
Parkinson’s disease: approval (China)
9M 2018 report
4.8% 5.4% 5.1%
-5%
0%
5%
10%
15%
20%
PD Market PD keycompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TDx)
16.0%
15.0%
15.5%
16.0%
16.5%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Neupro® PD – R3M TDx Share
6.2%
6.0%
6.5%
7.0%
7.5%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Neupro® PD – R3M TRx Share
-0.2% -0.2%-3.4%
-5%
0%
5%
10%
15%
20%
PD market PD keycompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TRx)
0.8%
-0.9%
17.1%
-5%
0%
5%
10%
15%
20%
PD Market PD keycompetitors
Neupro®
Neupro® PD vs. PD (KC) Market Growth (TDx)
Neupro® in-market performance 22
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.
U.S.
-3.2%
-0.4%
Europe Japan
Source data U.S.: U.S. IMS NPA - In-Market KPIs are based on TRx
-0.3%
+0.5%
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
34.7%
25.0%27.0%29.0%31.0%33.0%35.0%37.0%
Aug-17 Nov-17 Feb-18 May-18 Aug-18
Neupro® PD – R3M TDx Share
+18%
+5.9%
9M 2018 report
Translating scientific hypotheses into clinical development23
Evenity™ (romosozumab)osteoporosis
midazolam nasal spray acute repetitive seizures
bimekizumab (IL17A/F)psoriasispsoriatic arthritisankylosing spondylitis
Phase 3 program results Q4 2019Phase 3 to start Q4 2018Phase 3 to start Q4 2018
dapirolizumab pegol (CD40L antibody)systemic lupus erythematosus Phase 2b results (Oct 2018 - partner: Biogen)
padsevonil (PPSI)highly drug-resistant epilepsy Phase 2b results H1 2020
rozanolixizumab (FcRn)myasthenia gravisimmune thrombocytopeniaCIDP
Phase 2a results (Oct 2018)Phase 2a results Q4 2018Phase 2 to start Q1 2019
UCB6673 UCB7858 UCB0159
UCB0599 UCB0107 radiprodil (UCB3491)
FilingPhase 3Phase 2Phase 1
Bone
Immunology
Neurology
Evenity™ is the trade name of romosozumab which has been provisionally approved bythe U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA).CIDP: Chronic inflammatory demyelinating polyneuropathy
Changes since February 2018:• Midazolam acquired (April 2018) & filed (August 2018) ● UCB4144/VR942 available for license• Seletalisib in Sjögren's Syndrome and APDS deprioritized ● UCB0107 first in human
9M 2018 reportR&D milestones
SLE: Systemic Lupus ErythematosusITP: Immune thrombocytopenia
24
dapirolizumab pegolSLE
Phase 2b results
rozanolixizumabmyasthenia gravisPhase 2a results
padsevonilhigh drug resistant
epilepsyPhase 2b start
bimekizumab psoriasis
Phase 3 results
padsevonilhigh drug resistant
epilepsyPhase 2b results
seletalisib
romosozumabosteoporosis in
post-menopausal women
filing (EU)
bimekizumab psoriatic arthritis
Phase 3 start
bimekizumab ankylosing spondylitis
Phase 3 start
neurologyimmunologybone
UCB0107Phase 1 start
rozanolixizumabITP
Phase 2a results
romosozumabresubmission
(U.S.)
midazolamepilepsy
filing (U.S.)
2018 2019 2020
rozanolixizumabCIDP
Phase 2 start
rozanolixizumabmyasthenia gravisconfirmatory phase
start
9M 2018 reportEvenity™ (romosozumab) 25
An innovative investigational bone-forming therapy
STRUCTURE, FRAME, BRIDGE and ARCH• Phase 3 studies completed
Opportunity to build new bone and slow bone loss in osteoporosis patients at imminent risk of fragility fractures
Dual effect on bone - increases bone formation and decreases bone resorption
Under regulatory review in the U.S., Canada, Japan, Australia, Braziland EU, Switzerland
• UCB and Amgen resubmitted Biologics License Application (BLA) to the U.S. FDA (July 2018)
Manorama, living with osteoporosis
The trademark EVENITY™ is provisionally approved for use by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).EVENITY™ (romosozumab) is developed in partnership with Amgen globally.
9M 2018 report
Translating scientific hypotheses into clinical differentiation26
Dual blockade of IL-17F and IL-17A by bimekizumab
Dual blockade of IL-17F on top of IL-17A
will improve therapeutic efficacy versus targeting IL-17A alone
IL-17F
IL-17RAIL-17RC
IL-17A
Bimekizumab specifically and completely blocks IL-17F and IL-17A
IL-17F and IL-17A are twin cytokines
driving joint and skin inflammation
9M 2018 report
• 560 patients living with psoriasis1
• 52 weeks
• ustekinumab• placebo
• PASI90 response• IGA 0/1 response
Phase 3BE VIVID / PS0009
(NCT03370133)
Start Dec. 2017Results: Q4 2019
Bimekizumab Phase 3 development program in psoriasis 27
3 / 4 trials against active comparators -designed to demonstrate superiority
1 moderate to severe chronic plaque psoriasis IGA: Investigator's Global AssessmentPASI90: Patients experiencing at least 90% skin clearance Source: www.clinicaltrial.govPASI100: Patients experiencing 100% skin clearance
• 400 patients living with psoriasis1
• 56 weeks
• placebo
• PASI90 response• IGA 0/1 response
Phase 3BE READY / PS0013
(NCT03410992)
Start Feb. 2018Results: Q4 2019
Duration
Comparator
Primary endpoints@ week 16
• 700 patients living with psoriasis1
• 48 weeks
• secukinumab
• PASI100 response
Phase 3bBE RADIANT / PS0015
(NCT03536884)
Start June 2018Results: 2020
• 450 patients living with psoriasis1
• 56 weeks
• adalimumab
• PASI90 response• IGA 0/1 response
Phase 3BE SURE / PS0008
(NCT03412747)
Start Jan. 2018Results: Q4 2019
9M 2018 report
•400 patients with drug-resistant focal epilepsy• failed with ≥ 4 AED•experiencing ≥4 seizures / month
•padsevonil / placebo (5 arms)
•Seizure frequency• from baseline over the 12 week maintenance period (U.S., Japan)
• 75% responder rate (EU)
•55 patients with highly drug-resistant focal epilepsy• failed with ≥4 AED•experiencing ≥4 seizures / week
•padsevonil / placebo (2 arms)
•75 % responder rate* 31% padsevonil11% placebo
Padsevonil Phase 2 program in drug-resistant focal epilepsy 28
Patient sub-group with high unmet medical need
* Proportion of subjects who achieve ≥75 % reduction in focal seizure frequency
Comparator
Endpoints
Phase 2a(NCT02495844 / EP0069 )
Phase 2b (NCT03373383 / ARISE / EP0091)
Results H1 2020AES 2017
9M 2018 report
• 43 patients with moderate to severe MG
• diagnosis of myasthenia gravis @ screening• be considered for treatment with
immunological therapy
• 99 days
• placebo (2 arms)
• Change from baseline in Quantitative Myasthenia Gravis (QMG) score to visit 9 (day 29)
• Change from Baseline in Myasthenia Gravis-Composite score to Visit 9
• Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) score to Visit 9
Rozanolixizumab Phase 2a development programA first-in-class SubQ treatment for IgG-mediated diseases
subQ: sub-cutaneousIgG: immunoglobulin
Headline results (Oct 2018)
• 66 patients with primary ITP
• ≥ 3 months diagnosis @ screening• Platelet count <30x109/L @ screening and
<35x109/L @ baseline
• 12 weeks
• 5 arms
• Subjects experiencing at least one Treatment Emergent Event (TEAE) during the study
Comparator
Endpoints
Immune thrombocytopenia(NCT02718716)
Myasthenia gravis (NCT03052751)
Results Q4 2018interim results at ASH 2017
Duration
29
Study design currently discussed with health authorities
Chronic inflammatorydemyelinating
polyneuropathy
Phase 2 to start Q1 2019
9M 2018 report
Myasthenia gravis Immune thrombocytopenia Chronic inflammatory demyelinating polyneuropathy
• Antibodies target receptor sites of the neuromuscular junction
• Antibodies target platelets and destroy them
• Antibodies target components of peripheral nerves, causing damage to the myelin sheath
• Fatigue• Muscle weakness (eyes, neck and
jaws, respiratory muscles)
• Bruising• Nosebleeds• Purpura• Intracranial bleeding
• Motor deficits• Sensory deficits
• ~ 10 - 45 cases / 100 000 • ~ 10 - 60 cases / 100 000 • ~ 1 - 6 cases / 100 000
• Steroids• Plasma exchange (PEX)• IV immunoglobulin (IVIg)• Surgery (thymectomy)
• Corticosteroids & thrombopoeitin• IV immunoglobulin (IVIg)• Surgery (splenectomy)
• Corticosteroids• Plasma exchange (PEX)• IV / subQ immunoglobulin
Rozanolixizumab potential in multiple IgG autoantibody-mediated diseases with high unmet medical need
30
IV: IntravenoussubQ: sub-cutaneous
Current treatments partially stabilize the condition yet invasive, burdensome to patients & healthcare systems
9M 2018 report
Now first in human: UCB0107, an anti-Tau antibody forProgressive Supranuclear Palsy & Alzheimer’s disease
31
Source: UCB internal data AD: Alzheimer’s diseasePSP: Progressive Supranuclear Palsy
•Tau misfolding and aggregation leads to neuronal death and disease spread
•PSP is a rare, rapidly progressing tauopathy with debilitating cognitive & motor symptoms
•Alzheimer’s Disease is also a tauopathy, with high prevalence and economic impact
UCB0107 blocks tau uptake and aggregation
Key facts Key insights
Tau seeds spread from dying cells to
infect other neurons
UCB0107 was generated to block spreading of tau
seeds from patient materials
AD
PSP
Tau seed
9M 2018 reportTau misfolding leads to neuronal death and disease spread in AD and PSP
32
Microtubules stabilized by tau
Hyperphosphorylation of tau causing destabilization
of microtubules
Release and accumulation of
hyperphosphorylated tau
Release of tau seeds
Formation of tau oligomers
Formation of neurofibrillary tangles (NFTs)
Source: UCB internal data AD: Alzheimer’s diseasePSP: Progressive Supranuclear Palsy
9M 2018 reportTargeting tau spreading in early disease can delay or stop progression in AD and PSP
33
9M 2018 reportHY 2018 financials – foundation for FY 2018 34
Core product growth drive top and bottom line
CER: constant exchange rate*one-time other revenue of € 56 million for out-licensing the OTC-allergy drug Xyzal® (levoceterizine) in 2017
CER
+6%
+12%+7%
Actual
Revenue• Revenue (adjusted for one-time revenue*) € 2.27 billion• Net sales € 2.15 billion (+5%, +10% CER)
€ 2.27 billion
Total operating expenses • Overall operating expense ratio improved to 46%• R&D expenses phasing
€ 1.04 billion
Recurring EBITDA • Higher gross profit • Improved operating expenses ratio
€ 794 million
Profit of the Group• € 551 million attributable to UCB shareholders (+28%)
€ 574 million
Core earnings per share Based on 188 million weighted average shares outstanding (2017: 188 million)
€ 3.09
+2%
+27%
+22% +27%
-1% +4%
+4%
adjusted
+33%
+16%
9M 2018 reportCore product growth 35
Cimzia®, Vimpat®, Keppra®, Briviact® + Neupro® = 87% of net sales
CER = constant currency exchange rates* Excluding € 65 million hedging
Cimzia® +2% (+11% CER)• Sustainable growth in all regions
Vimpat® +10% (+20% CER)• Strong growth in all markets
Keppra® -5% (+2% CER)• Reflecting both, the established brand
and the maturity
Briviact® € 60 million• Strong U.S. growth
Neupro® -4% (0% CER)• Stable at constant exchange rates
HY 2018 net sales*€ 2 081 million
(+2%; CER: +10%)
9M 2018 report2018 HY report: recurring EBITDA 36
Solid growth - Improved operating expenses ratio
Numbers may not add due to rounding EBIT: Earnings before interest and taxesCER: constant exchange rate EBITDA: Earning before interests, taxes, depreciation and amortization charges
For the six months ended 30 June Actual Variance
€ million 2018 2017 Actual rates CER
Revenue 2 269 2 230 2% 6% Net sales 2 146 2 036 5% 10% Royalty income and fees 56 58 -4% 6% Other revenue 67 136 -50% -50%
Gross profit 1 696 1 666 2% 7% Marketing and selling expenses -442 -464 -5% 2% Research and development expenses -500 -474 5% 9% General and administrative expenses -88 -93 -5% -2% Other operating income / expenses (-) -9 -16 -48% -42%
Total operating expenses -1 039 -1 047 -1% 4%
Recurring EBIT (REBIT) 657 619 6% 11% Amortization of intangible assets 79 78 2% 6% Depreciation charges 58 45 29% 36%
Recurring EBITDA (REBITDA) 794 742 7% 12%
9M 2018 report2018 HY report: profit 37
Numbers may not add due to roundingCER: constant exchange rateEBIT: Earnings before interest and taxes
For the six months ended 30 June Actual Variance
€ million 2018 2017 Actual rates CER
Recurring EBIT 657 619 6% 11% Impairment charges 0 4 -100% -100% Restructuring expenses -4 -7 -41% -39% Gain on disposals 0 0 N/A N/A Other non-recurring income / expenses (-) 23 3 > 100% > 100%
Total non-recurring income / expenses (-) 19 1 > 100% > 100%
EBIT (operating profit) 676 619 9% 14% Net financial expenses (-) -46 -55 -17% -16% Result from associates -1 0 N/A N/A
Profit before income taxes 629 564 12% 17% Income tax expense (-) / credit -56 -114 -51% -49%
Profit from continuing operations 573 450 27% 33% Profit / loss (-) from discontinued operations 1 1 -44% -62%
Profit 574 451 27% 33% Attributable to UCB shareholders 551 431 28% 33% Attributable to non-controlling interests 23 20 15% 29%
Profit attributable to UCB shareholders 551 431 28% 33%
9M 2018 report2018 HY report: core earnings per share 38
Strong growth of core net profit
Numbers may not add due to roundingCER: constant exchange rateEPS: earnings per share
For the six months ended 30 June Actual Variance
€ million 2018 2017 Actual rates CER
Profit 574 451 27% 33% Attributable to UCB shareholders 551 431 28% 33% Attributable to non-controlling interests 23 20 15% 29%
Profit attributable to UCB shareholders 551 431 28% 33% Total non-recurring income (-) / expenses -19 -1 > 100% > 100% Income tax on non-recurring expenses (-) / credit 0 -1 -59% -59% Financial one-off income (-) / expenses 0 0 N/A N/A Income tax on financial one-off income / expenses (-) 0 0 N/A N/A Profit (-) / loss from discontinued operations -1 -1 -44% -62% Amortization of intangibles linked to sales 61 61 1% 5% Income tax on amortization of intangibles linked to sales -11 -12 -6% -5%
Core profit attributable to UCB shareholders 581 477 22% 27% Weighted average number of shares (million) 188 188 0%
Core EPS attributable to UCB shareholders 3.09 2.53 22% 27%
9M 2018 report
Numbers may not add due to roundingCER: constant exchange rate
2018 HY report: key product net sales performance 39
For the six months ended 30 June Actual Variance
€ million 2018 2017 Actual rates CER
Core products 1 801 1 741 3% 12% Immunology / CimziaP
® 679 663 2% 11% Neurology
VimpatP
® 522 477 10% 20% KeppraP
®P (including KeppraP
®P XR + E KeppraP
®P) 392 412 -5% 2%
NeuproP
® 148 154 -4% 0% BriviactP
® 60 36 67% 83% Established brands 280 302 -7% -3%
ZyrtecP
®P (including Zyrtec-DP
®P / CirrusP
®P) 58 61 -6% -3%
XyzalP
® 51 54 -6% 0% Other products 171 186 -8% -5%
Net sales before hedging 2 081 2 043 2% 10% Designated hedges reclassified to net sales 65 -8 > -100% Total net sales 2 146 2 036 5% 10%
9M 2018 reportOne UCB today: A global player 40
Presence in 38 countries complemented by a robust network of partners
Situation at 30 June 2018
7 480employees
globally
9M 2018 report 41Stable shareholder base with free-float of 62%Weighted average shares outstanding in 2018: 188 million
“Free float” investors by region
Source: Notifications, FactSet and UCB underlying ownership analysis, October 2018
9M 2018 report 42
Antje Witte, Vice President Investor Relations• Phone: +32 2 559 9414• E-mail: antje.witte@ucb.com
Neil Wallace, Director Investor Relations• Phone: +32 2 386 2869• E-mail: neil.wallace@ucb.com
Isabelle Ghellynck, Director Investor Relations Check out our IR App – stay• Phone: +32 2 559 9588 tuned wherever you go • E-mail: isabelle.ghellynck@ucb.com
Nathalie Deldime, Investor Relations Manager• Phone: +32 2 559 9291• E-mail: nathalie.deldime@ucb.com
Your UCB Investor Relations team
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