Download Investor FactBook - FY 2014 results27-February

2014 Full Year Results
Investor Factbook
2014 Full Year Results
1
Our Company ....................................................................................................................................................................................... 3
Vision
3
Strategy
3
Board Members
4
Executive Committee
4
Employees
5
Locations
5
UCB: A Solid Heritage
6
Financials ............................................................................................................................................................................................. 7
Key Financials
7
Net sales
7
Net sales by region and product
8
R & D Expenses (€ m)
8
Shareholder structure and free-float by region
9
Target Therapy Areas ........................................................................................................................................................................ 10
Disease Areas .................................................................................................................................................................................... 11
Epilepsy
11
Parkinson’s disease
11
Restless legs syndrome
11
Rheumatoid arthritis
11
Crohn’s disease
12
Osteoporosis
13
Systemic lupus erythematosus
13
Core Medicines: Cimzia®, Vimpat®, Neupro® (CVN)........................................................................................................................ 14
Cimzia®
14
Vimpat®
15
Neupro®
15
Development Pipeline Information ..................................................................................................................................................... 16
Partners ............................................................................................................................................................................................. 17
Drug Development Process ............................................................................................................................................................... 18
Research & Development .................................................................................................................................................................. 19
2015 Financial Calendar .................................................................................................................................................................... 20
Disclaimer and Safe Harbor ............................................................................................................................................................... 20
Contacts ............................................................................................................................................................................................. 20
Investor FactBook FY2014
2
Our Company
Vision
UCB aspires to be the patient-centric global biopharmaceutical leader transforming the lives of people living with
severe diseases.
Strategy
Since 2004, our strategy has been focused on delivering superior and sustainable solutions to people living with
severe diseases, targeting two areas: neurological diseases and diseases of the immune system. In each of these
areas, we constantly strive to obtain better patient and healthcare consumer insights while moving science forward to
create unique solutions and efficient ways to deliver them.
In 2015, we continue to focus on our strategic growth priorities:






®
®
®
Grow Cimzia , Vimpat , and Neupro
Advance and prepare launch of the next wave of promising new solutions:
brivaracetam, epratuzumab, and romosozumab;
Deliver breakthrough medicines
Reach competitive profitability;
Constantly ensure quality and compliance with laws
and regulations and;
Develop passionately engaged colleagues
and business partners.
These priorities are underpinned by constantly
ensuring quality and compliance with laws and
regulations, and developing passionately engaged colleagues and business partners.
In our early stage pipeline, we focus on potential breakthroughs (i.e. new medicines that can transform patients’ lives
and UCB) that offer true differentiation and systematically discontinue projects that do not. The productivity, wealth
and quality of our pipeline – internal and external – allow us to make these choices.
Our established research strategy for the breakthrough focuses on first or second-in class innovative approaches,
prioritizing projects that have a clear proof of concept and clear end points. We focus our manufacturing network on
R&D scale-up until launch. Where appropriate, we augment our internal capabilities using strategic partnerships, both
for large and small molecules, in the commercial phase of the product, while securing cost-effective supply.
As for our commercial strategy, we have our own presence covering specialist physicians, payers and patient groups,
in North America, Europe and major emerging markets.
In all areas, we continue to learn from best-in-class companies outside the biopharma industry in areas such as
innovation, customer insights, cost management and activity-based management.
As a result of our strategy, UCB aims to exceed the biopharma industry’s compounded growth. We also expect to
invest more than our peers in R&D proportionally to our sales, while accelerating towards peer profitability through
reallocation of resources to best impact.
With no major patent expiry for many years and with three new core medicines fueling our growth, plus a rich pipeline
and cutting edge science, UCB is now poised to build a strong global presence in neurology and immunology – and to
deliver significant returns to shareholders. Thanks to the current performance and growth of our core medicines, we
®
®
®
confirm our ambition to reach more than 1.5 million patients with Cimzia , Vimpat and Neupro , representing peak
sales of at least € 3.1 billion in the second half of the decade.
Investor FactBook FY2014
3
Board Members
The Board of Directors is made up of 12 members:
First
appointed as End of term
Director
of office
Independent
Audit
Scientific
Director
Committee Committee
Gerhard Mayr, Chairman
2005
2015
x
x
Evelyn du Monceau, Vice Chair
1984
2015
Jean-Christophe Tellier, CEO & Executive
Director
2014
2018
Albrecht De Graeve
2010
2017
Arnoud de Pret
2005
2015
Harriet Edelman
2012
2016
x
Kay Davies
2014
2018
x
x
Charles-Antoine Janssen
2012
2016
Jean-Pierre Kinet
2008
2015
x
x
Tom McKillop
2009
2016
x
Norman J. Ornstein
2008
2015
x
Cédric van Rijckevorsel
2014
2018
Governance,
Nomination &
Compensation
Committee
x
x
x
x
x
x
For additional information about UCB Board members and the Board Committees, please refer to:
http://www.ucb.com/investors/Governance/Corporate-governance
Executive Committee
The Executive Committee is made up of 10 members
Jean-Christophe Tellier, CEO and Chair of the Executive Committee
Joined UCB
Appointed
June 2011
July. 2011
Emmanuel Caeymaex, Immunology Patient Value Unit Head
Mar 1994
Feb. 2015
Fabrice Enderlin, Chief Talent Officer
Jan. 2008
March 2008
Ismail Kola, New Medicines Patient Value Unit Head and Chief Scientific Officer
Nov. 2009
Nov. 2009
Iris Löw-Friedrich, Chief Medical Officer
Sept. 2006
March 2008
Mark McDade, Chief Operating Officer
April 2008
Sept. 2008
Anna Richo, General Counsel
Nov. 2012
Nov. 2012
Mar 2015
Mar 2015
Sept. 2006
Jan. 2007
Oct. 2010
Feb. 2015
Bharat Tewarie, Chief Marketing Officer
Detlef Thielgen, Chief Financial Officer
Jeff Wren, Neurology Patient Value Unit Head
For additional information about UCB Executive Committee, please refer to:
http://www.ucb.com/investors/Governance/Corporate-governance
Investor FactBook FY2014
4
Employees (headcount)
Employees by function (2014)
Total: 8 684
Employees by region (2014)
Total: 8 684
Total Employee Headcount
(FY)
9 048
8 927
8 732
8 684
2013
2014
8 506
2010
2011
2012
Headquartered in Brussels (Belgium), UCB is present in 36 countries.
Investor FactBook FY2014
5
UCB: A Solid Heritage
1990s: approval of
Keppra®,
a novel
anti-epileptic
1928: Emmanuel
Janssen establishes
UCB in Brussels
2006: UCB acquires
German pharma
company Schwarz
Pharma
Today
2005: UCB divests
non-pharma business
1980s: UCB registers
its novel antihistamine
Zyrtec®
2004: UCB acquires
British biotech
company Celltech
1936: UCB enters
the United States
1928
1936
Chemical Group
Investor FactBook FY2014
1980s
1990s
Primary Care Pharma
2004
Launch of new
medicines
2005
2006
2008-2012
Today
Specialty Bio-Pharma
Focus: CNS + immunology
6
Financials
Key Financials
2010
€ million
2011
2012
2013
(restated)
(restated)
(restated)
2014
Revenue
3 218
3 246
3 462
3 133
3 344
Net sales
2 786
2 876
3 070
2 795
2 938
705
778
861
886
928
22%
24%
25%
28%
28%
Recurring EBIT (REBIT)
467
439
444
297
379
Recurring EBITDA
731
687
684
536
609
23%
21%
20%
17%
18%
Net profit including non-controlling interests
103
238
245
145
199
Core EPS (€ per non-diluted share)
1.99
1.91
2.10
1.24
1.69
1 525
1 548
1 766
1 998
1 611
Ratio net debt / REBITDA
2.09
2.25
2.58
3.73
2.65
Equity ratio
51%
51%
49%
44%
48%
506
292
355
288
512
78
137
221
344
161
R&D expenses
Ratio R&D expenses / revenue
Ratio REBITDA / revenue
Net debt
Cash flow from operating activities
Capital expenditure (including intangible assets)
Mature Products Net Sales FY2014
665
Keppra®
712
163
Zyrtec®
204
Total mature products sales
€ 1 470 million (-9%)*
96
Xyzal®
114
55
Nootropil®
58
433
Other
482
0
100
(€ million)
200
300
400
2014
500
600
700
800
2013
*Adjusted for product divestitures (-2%)
Investor FactBook FY2014
7
Net sales by region and product
2013 net sales - geographical area
2014 net sales - geographical area
France
6%
France
5%
North
America
37%
North
America
39%
Germany
8%
Germany
8%
Italy
5%
Italy
5%
Spain
5%
Spain
5%
RoW other
4%
Emerging
markets
(BRICMT)
11%
Europe other
Japan
12%
8%
RoW other
4%
U.K. &
Ireland
4%
Emerging
markets
(BRICMT)
11%
2013 net sales - by product therapeutic
area (€ million)
Neupro®,
182
Keppra®,
665
Immunolo
gy Allergy,
318
Vimpat®,
411
U.K. &
Ireland
4%
2014 net sales - by product / therapeutic
area (€ million)
Cimzia®,
594
Keppra®,
712
Europe other
Japan 12%
7%
Cimzia® ,
797
Neupro®,
200
Other,
546
Immunolo
gy Allergy,
259
Vimpat®,
471
Other,
530
CNS other, 16
CNS other, 984
Ratio gross profit / revenue
69%
69%
R & D Expenses (€ m)
69%
28%
28%
24%
22%
25%
69%
67%
3 218
3 246
3 462
3 133
3 344
705
778
861
886
926
2010
2011
restated
2012
restated
2013
2014
2010
2011
restated
2012
restated
2013
2014
Revenue
Investor FactBook FY2014
Margin
R & D expenses
R&D expenses as % of revenue
8
Share price history (Jan 1, 2014 – Dec 31, 2014)
(rebased to 100)
1000
stock performance
750
100
500
50
250
-
daily volume in mn of shares
150
0
Jan-14
Feb-14
Mar-14
Apr-14
Volume
May-14
UCB
Jun-14
Jul-14
Aug-14
MSCI EU Pharma
Sep-14
Oct-14
Nov-14
Dec-14
MSCI US Pharma & Biotech
Shareholder structure and free-float by region (January 2015)
th
Since January 5 2015, UCB’s capital amounts to € 583 516 974, divided in 194 505 658 ordinary shares with no
nominal value.
UCB’s main shareholder is Financière de Tubize S.A. (34.12%), a company listed on Euronext Brussels.
“Free float” (64%) investors by region
Investor FactBook FY2014
9
Target Therapy Areas
UCB focuses on therapy innovation for people living with severe diseases of the central nervous system and in
immunology.
CNS1
The central nervous system (CNS) controls most functions of the body and mind. It consists of two parts: the brain
and the spinal cord.
The brain is the center of our thoughts, the interpreter of our external environment, and the origin of control over body
movement. Like a central computer, it interprets information from our eyes (sight), ears (sound), nose (smell), tongue
(taste), and skin (touch), as well as from internal organs such as the stomach.
The spinal cord is the highway for communication between the body and the brain. When the spinal cord is injured,
the exchange of information between the brain and other parts of the body is disrupted.
Immunology2
The immune system is a complex network designed to defend the body against attacks by foreign bodies. The word
immunity comes from the Latin immunis, or “exempt.” Usually these attackers are bacteria, fungi or parasites. If the
immune system loses the ability to distinguish between self and non-self (or foreign targets), then autoimmunity can
occur, leading to diseases such as rheumatoid arthritis, inflammatory bowel disease or lupus.
The immune system is made up of cells, tissues and organs, including T and B cells, lymph nodes, mucosal (lining)
surfaces of the intestines, the spleen and tonsils, as well as chemical mediators such as cytokines (eg tumor necrosis
factor or TNF) and receptors. The immune system has complex mechanisms of communication enabling it to
recognize and defend the body against thousands of different foreign attackers.
Immunology is a branch of biomedical science that covers the study of the immune system in all organisms.
Immunology examines the physiological functioning of the immune system in states of both health and disease.
1.
2.
Source: http://www.christopherreeve.org/site/c.ddJFKRNoFiG/b.4452157/k.3E9D/What_is_the_Central_Nervous_System.htm
Adapted from http://www.niaid.nih.gov/topics/immunesystem/pages/whatisimmunesystem.aspx
Investor FactBook FY2014
10
Disease Areas
Epilepsy
Epilepsy is excessive electrical activity in the nerve cells in the brain that leads to epileptic seizures. Seizures are brief
episodes with a variety of symptoms ranging from strange sensations, emotions and behavior, jerking or stiffening of
the limbs and body with muscle spasms and loss of consciousness. In partial seizures the abnormal electrical activity
is confined to a part of the brain, while in generalized seizures the disturbance involves large parts on both sides of
the brain.
•
Prevalence :
•
Incidence :
•
1
2
5.2 million people
50.4 cases / 100 000 population (U.S. & EU)
1
Market size :
USD 2.9 billion
Parkinson’s disease
Parkinson’s disease (PD) is a progressive disorder of the nervous system caused by a gradual loss of nerve cells in
the brain that produce a chemical called dopamine. Symptoms of the disorder include motor symptoms such as
tremors, stiffness, and slowing of movement. Additionally, non-motor symptoms are common including thinking
difficulties, emotional changes, sleep problems, bladder problems, constipation, and sexual dysfunction. As the
disease progresses, the increasing motor disability affects activities of daily living including washing, getting dressed,
speaking, and writing. Treatments aim to restore dopamine levels and can help symptoms, but there is no cure for the
disorder. Treatments include dopamine agonists (usually given early in the disease) and leva dopa (usually given later
in the course of the disease). Surgery on certain regions of the brain are sometimes employed when drugs are not
effective.
•
3
Prevalence :
•
Incidence :
•
Market size :
3
4.1 – 4.6 million people
10 - 14 cases / 100 000 population (worldwide)
4
USD 2.3 billion
Restless legs syndrome
Restless legs syndrome (RLS) usually occurs deep within the lower part of the leg. It is characterized by a strong urge
to move the legs and is accompanied by an extremely bothersome sensation in the legs. Symptoms become worse
in the evening and during the night, preventing patients from falling asleep and making it impossible to have a restful
sleep. Sleep can also be interrupted by involuntary leg movements. Although the exact cause of RLS still is unclear,
dys-regulations in the endogenous dopaminergic system might play a role. For the majority of patients, for whom a
genetic basis of their disease is obvious, dopamine-agonists are regarded as a first line treatment. For a smaller
proportion of patients there might be secondary reasons involved, like iron deficit in the peripheral blood. RLS affects
more women than men (roughly 2:1) and although it can affect all ages, usually the diagnosis is made in middle-aged
people and the elderly.
•
Prevalence :
•
Incidence :
1
5
54.4 million people
~1 000 – 2 000 cases / 100 000 population (U.S. & EU)
•
Market size :
1.
2.
3.
4.
5.
Decision Resources 2009 – 2013; 7 major markets include: France, Germany, Japan, Italy, Spain, U.K. and U.S.
http://www.neurology.org/content/77/10/1005.full.html
WHO Neurological Disorders Report , 2006
Decision Resources, July 2013
Szentkiraly 2011
1
Investor FactBook FY2014
USD 193 million
11
Rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic, systemic disorder that causes the immune system, which usually fights
infection, to rapidly attack the joints. The result is painful inflammation, known as arthritis, and joint damage that can
be disabling. This slows patients down, and ultimately leads to a substantial loss of functioning and mobility that limits
a patient’s ability to live their life. This impacts both patient’s physical abilities as well as their mental health and social
functioning.
Over 5 million people suffer from RA in the major seven markets. Women are three times more likely to be affected
than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 30-50 years of
1
age .
•
2
Prevalence :
•
Incidence :
•
Market size :
3
5 million people
~20-50 cases / 100 000 population (U.S. & EU)
2
USD 10.3 billion
Crohn’s disease
Crohn’s disease is an idiopathic, chronic inflammatory process of the gastrointestinal (GI) tract that can involve any
part of the gastrointestinal tract from the mouth to the anus. The effect appears to be due to the body’s immune
system attacking healthy cells in the gastrointestinal tract, causing inflammation. Because it is caused by the immune
system, CD is classified medically as an autoimmune disorder. This means that the body is producing antibodies
against itself. Together with ulcerative colitis, CD belongs to the group of illnesses called inflammatory bowel disease
(IBD).
The lives of people with CD are frequently disrupted by flare-ups of the condition. Most common symptoms are:
fever, abdominal pain, weight loss and diarrhea; which can lead to an urgent need to use the bathroom. Coupled with
the fact that the condition is often diagnosed in young adults, a time in life when one is typically faced with major lifedecisions such as college, new jobs and relationships, CD limits a sufferer’s ability to lead a normal life.
There is still some uncertainty about how CD is caused. A number of genetic and environmental factors are
associated with it but their role is not clear. However, the disease is thought to be an abnormal response of the body’s
immune system to bacteria found in the intestines.
•
Prevalence :
•
Incidence :
•
Market size :
1.
2.
3.
4.
5.
Rindfleisch JA, Muller D. Am Fam Physician. 2005; 72: 1037-1047.
Decision Resources (2011). The 7 major markets include: France, Germany, Japan, Italy, Spain, the UK and the US.
Tobón GJ, Youinou P, Saraux A. J Autoimmun. 2010; 35: 10-14
Decision Resources 2012
World Journal of Gastroenterology 2012
4
5
918 000 people
~3-10 cases / 100 000 population (U.S. & EU)
4
Investor FactBook FY2014
USD 3.8 billion
12
Osteoporosis1,2,3
Osteoporosis affects many women after menopause and is a disease that weakens bones over time, making them
thinner and more likely to break. Post-menopausal women with osteoporosis have a greater risk for breaking a bone.
Such a break, or fracture, may be a life-changing event. About one in three women over age 50 will have an
osteoporosis-related fracture, and once that happens, the chances of another are much higher. The International
Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.
•
Prevalence :
•
Incidence :
•
Market size :
4
200+ million people
5
1.66 million people
6
USD 451 million
Systemic lupus erythematosus
Systemic lupus erythematosus (SLE), or lupus, is a chronic, autoimmune disease that can damage any part of the
body, including skin, joints, and organs inside the body, resulting in inflammation and tissue damage. Immunological
aberrations in SLE patients produce excessive amounts of antibodies directed against self, “auto-antibodies”. Chronic
means that the signs and symptoms tend to last longer than several weeks and often for many years. It is a disease
of flares (the symptoms worsen and you feel ill) and remissions (the symptoms improve and you feel better). Some
patients experience a relatively benign disease with little medical intervention, while others can have a serious and
aggressive progression that can lead to significant and potentially life-threatening damage to organs such as the
kidneys, brain, heart and lungs.
No cure for SLE yet exists. There is a 85% five-year survival rate. The morbidity and mortality of SLE results from
tissue damage due to disease progression. However, people with non-organ threatening aspects of SLE can lead a
full and normal life. The cause of SLE is unknown, but is thought to be multi-factorial with genetic, hormonal and
environmental factors playing a role.
•
Diagnosed prevalence :
•
Incidence :
•
1.
2.
3.
4.
5.
6.
7.
7
7
622 000 million people
~3.4 cases / 100 000 population (US & EU)
7
Market size :
USD 910 million
Osteoporosis Foundation. “What is Osteoporosis.” Accessed September 2013 from http://www.nof.org/articles/7.
International National Osteoporosis Foundation.” Facts and Statistics.” Accessed September 2013 from http://www.iofbonehealth.org/factsstatistics#category-16.
International Osteoporosis Foundation. "Osteoporosis in the European Union in 2008: Ten years of progress and ongoing challenges."
Accessed September 2013 from http://www.iofbonehealth.org/osteoporosis-european-union-ten-years-progress-and-ongoing-challenges
http://www.iofbonehealth.org/epidemiology
http://www.who.int/nutrition/topics/5_population_nutrient/en/index25.html; denotes hip fractures only
Decision Resources (2011). The 7 major markets include: France, Germany, Japan, Italy, Spain, the UK and the US.
Pharmacor, Decision Resources, Nov 2013; 7 major markets (include: France, Germany, Japan, Italy, Spain, U.K. and U.S.)
Investor FactBook FY2014
13
Core Medicines: Cimzia®, Vimpat®, Neupro® (CVN)
®
®
®
Our “core medicines” are: Cimzia , Vimpat and Neupro , which we continue to grow through new indications and
global launch roll-outs.
797
Cimzia®
594
471
Vimpat®
Total core medicines sales
€ 1 468 million (+24%)
411
200
182
Neupro®
0
100
200
(€ million)
300
400
2014
500
600
700
800
900
2013
Cimzia® quarterly net sales
Patient access:
•
•
•
•
•
•
Rheumatoid arthritis: available in 48 countries, including U.S., EU, Japan
Crohn’s disease: available in 9 countries, including U.S.
Psoriatic arthritis: available in 38 countries, including U.S. & EU
Axial spondyloarthritis / ankylosing spondylitis: available in 38 countries, including U.S. (AS only) & EU
Juvenile idiopathic arthritis: Phase 3 clinical trial started March 2013 with results expected in H1 2016
®
Psoriasis: strategic partnership with Dermira for the exclusive rights to develop Cimzia in psoriasis in the
U.S., Canada and the EU
Investor FactBook FY2014
14
Vimpat® quarterly net sales
Patient access:
• Partial-onset seizures, adjunctive therapy: approved in 43 countries, including U.S. & EU
• Partial-onset seizures - monotherapy (US): approved September 2014
• Partial-onset seizures - monotherapy (EU): Phase 3 clinical trial program on-going; results expected in Q4 2015
• Partial-onset seizures, adjunctive therapy in Asia: Phase 3 results (October 2014); submission to Japanese and
Chinese authorities planned in 2015
• Partial-onset seizures - adjunctive therapy in children: Phase 3 clinical trial started in September 2013; results
expected in 2017
• Phase 3 clinical trial in PGTCS adjunctive therapy to start in 2015
Neupro® quarterly net sales
Patient access:
• Parkinson’s disease: approved in 44
countries, including U.S., EU & Japan
• Restless Legs Syndrome : approved in 14
countries, including U.S., EU & Japan
• Parkinson’s disease in China: Phase 3
results (February 2015); submission
planned in 2015
Investor FactBook FY2014
15
UCB’s Development Pipeline
brivaracetam
UCB is evaluating the potential of brivaracetam in the treatment of epilepsy as adjunctive therapy in partial onset
seizures (POS). Brivaracetam is a novel high-affinity synaptic vesicle protein 2A (SV2A) ligand. The positive data
from the most recent Phase 3 study demonstrated robust and clinically relevant seizure reduction in predominantly
treatment resistant patients, and tolerability was consistent with previous brivaracetam trials. In January 2015, the
New Drug Application (NDA) for the Food & Drug Administration (FDA) in the United States and the Marketing
Authorization Application (MSS) for the European Medicines Agency (EMA) were both filed to review brivaracetam as
adjunctive therapy for the treatment of partial-onset seizures in patients aged 16+ with epilepsy.
epratuzumab
Epratuzumab is a CD22-targeted monoclonal antibody under investigation for the treatment of SLE. CD22 is a B cell
specific surface protein that influences B cells migration and activation. The product was licensed from
Immunomedics. Under the agreement, UCB owns the rights and is responsible for the clinical development, and
commercialization of epratuzumab in all autoimmune disorders including SLE.
romosozumab1,2
Romosozumab is a bone-forming agent that inhibits sclerostin. It is currently being studied for its potential to reduce
fracture risk in an extensive global Phase 3 program. This program includes two pivotal studies evaluating
romosozumab against both placebo and active in more than 10,000 women with post-menopausal osteoporosis. An
additional Phase 3 study began in June 2014 to compare the efficacy and safety of romosozumab in men with
osteoporosis, with first results expected in H1 2016. Both Phase 3 programs are in collaboration with Amgen.
1. Partial onset seizures
2. ClinicalTrials.gov Accessed September 2013 from http://clinicaltrials.gov/ct2/show/NCT01631214?term=Romosozumab&rank
3. ClinicalTrials.gov Accessed September 2013 from http://clinicaltrials.gov/ct2/show/NCT01575834?term=AMG+785&rank=12
Investor FactBook FY2014
16

Partners
UCB is committed to accessing assets and capabilities through strong, mutually-advantageous agreements with
external organizations. We seek to find these agreements across our value chain. In drug discovery, we have
research agreements with leading universities and research institutions in Asia, Europe and North America; in drug
development, we have agreements with, amongst others, Amgen, Millenium and Wilex; in drug manufacturing, we
partner with Boehringer Ingelheim, Lonza and Sandoz, amongst others; and in drug commercialization, we are
partnering with AstraZeneca, GSK, Novartis, Otsuka, Pfizer and Sanofi Aventis, amongst others.
•
Amgen Inc.: A partnership aimed at the research, development and commercialization of romosozumab, an
antibody which works against sclerostin, a protein discovered by UCB, for the treatment of bone diseases and
disorders such as osteoporosis.
•
Astellas Pharma Inc. (“Astellas”): UCB entered into an agreement with Astellas in January 2012 to jointly
®
develop and commercialize Cimzia for rheumatoid arthritis (RA) in Japan. Under this agreement, UCB
manufactures and supplies the product for commercialization. Astellas manages the distribution exclusively,
®
and both Astellas and UCB jointly develop and commercialize Cimzia in Japan.
•
Daiichi Sankyo: UCB and Daiichi Sankyo entered into a strategic partnership in November 2014 to jointly
®
commercialize Vimpat for epilepsy patients in Japan.
•
Dermira: UCB and Dermira entered into a strategic collaboration in dermatology to broaden patient access to
®
Cimzia .
•
Immunomedics Inc.: Immunomedics Inc. has granted to UCB the exclusive worldwide rights to develop,
market and sell epratuzumab for all non-cancerous human diseases including autoimmune disease
indications.
•
Otsuka Pharmaceuticals: UCB and Otsuka Pharmaceuticals have entered into collaboration agreements
®
pertaining to the development, license and supply of Neupro in Japan, a development and commercialization
®
contract relating to Keppra in Japan.
•
PRA: In 2011, UCB announced that it entered into a strategic partnership with PRA to drive UCB’s
operational clinical development activities. The agreements are effective for all of UCB’s new clinical study
programs on a global basis.
•
Parexel: UCB has entered into a strategic regulatory partnership with Parexel providing comprehensive
lifecycle maintenance and other regulatory support for UCB’s legacy products.
•
Sanofi: UCB and Sanofi entered into a scientific and strategic collaboration for the discovery and
development of innovative anti-inflammatory small molecules which have the potential to treat a wide range of
immune-mediated diseases in areas such as gastroenterology and arthritis.
Investor FactBook FY2014
17
Drug Development Process
Year 1
2
3
4
5
6
7
8
9
10
11
12
13
Product registration & approval
Marketing & launch
Development
A pre-marketing strategy may have been instigated as
early as Phase I trials to ensure that the market's needs
are incorporated into the new drug's overall development,
but more usually during the later phases when clinical
results are promoted at international symposia in order to
develop an awareness amongst the medical community
who will ultimately be prescribing the new product. A
Sales force will be trained and will begin an intense sales
and marketing campaign prior to launch.
New drug application
Phase IV trials
When a product is considered safe
and effective from Phase III trials, it
must be authorized in each individual
country before it can be marketed. All
data generated about the molecule is
collected and submitted to the
regulatory authorities in the US (FDA),
European Union (EMA) and Japan
(PMDA) and other countries which
may require their own national
approvals.
Phase IV trials are conducted after a
new drug has been granted a license,
approved and launched. In these
studies, the new drug is prescribed in
an everyday healthcare environment
using a much larger group of
participants (two to five thousand
patients). This enables new treatment
uses of the new drug to be developed,
comparisons with other treatments for
the same condition to be made, and
determination of the clinical
effectiveness of the new drug in a a
wider variety of patient types, and
more rare side effects, if any, may be
detected.
Clinical development
Phase I
Phase II
Phase III
Phase I trials are conducted primarily
to determine how the new drug works
in humans, its safety profile and to
predict its dosage range. It typically
involves between fifty and one hundred
healthy volunteers.
Phase II trials test for efficacy as well
as safety and side effects in a group
of between one hundred to three
hundred patients with the condition for
which the new drug is being
developed.
Phase III trials involved a much larger group of patients,
between several hundred and several thousand, which will
help determine if the new drug can be considered both
safe and effective. It will usually involve a control group
using standard treatment or a placebo as a comparison.
Pre-clinical phase
Manufacturing
Pre-clinical dev.
IND application
M anufacturing
Pre-clinical development
Application for Investigational new Drug
The manufacturing process for the
new drug is initiated and developed to
produce it in sufficient quantities for
pre-clinical testing and clinical trial
purposes.
Pre-clinical development begins before
clinical trials or testing in humans
may begin and during which important
safety and pharmacology data are
collected.
An application for an IND is made to
the FDA, EMA and/or other regulatory
agencies for permission to administer
a new drug to humans in clinical
trials.
Research phase
Lead discovery and lead optimization
Research
The initial molecules are further tested in a wider range of biochemical and other models in order
to establish that the lead compounds have the potential to become a drug.
Exploratory Research
Hit identification, UCB SLAM
The hypothesis is validated using
biochemical methods and in vivo
testing to ensure that the scientific
approach is relevant to the disease of
interest. The relevant biology is
investigated and drug starting points
identified.
Investor FactBook FY2014
18
Research & Development
Patient Value Units - New Medicines
The goal of New Medicines is to build a prolific pipeline of best-for-patient (first and/or best-in-class molecules of
maximum value to patients, physicians and payers) molecules that enables UCB to launch one new product every
other year, by channeling exquisite science for industry-beating performance across six key priorities:
1. Deliver differentiated molecules
2. Increase success rates
3. Implement extreme networking and open innovation model
4. Enhance scientific excellence
5. Increase efficiency
6. Strategic asset partnering
Patient Value Practices - Development / Medical Practices
The mission of Development is to support the development of products with proven value to patients suffering from
severe diseases.
As the Patient Solution Company UCB focuses on patients and empowers Patient Value Practices teams of experts
to drive their patient solutions in comprehensive missions along the value chain. Within the Patient Value Practices
we strive for operational excellence in clinical development, medical affairs, regulatory affairs, project management,
and leadership supporting PVPs within and beyond Development. In doing so, we aim to be a “best-in-class”
development organization that brings innovative solutions to patients – minimizing the time to our global market and
maximizing value and quality of our products to ensure successful patient access all over the globe.
Two main research centers
•
Biologics pilot plant – Braine-l’Alleud,
Belgium
•
Biologics R&D centre - Slough, U.K.
World-class expertise in selected therapeutic areas
and disease mechanisms.
Connecting science in new ways - chemistry (small,
chemically-derived molecules) and biology (large
antibody-based molecules), to leverage the potential
of these two disciplines.
“Open innovation” model based on strong
partnerships with other biotech companies and
prominent universities.
Investor FactBook FY2014
19
2015 Financial Calendar
9M
Interim
Report
FY 2014
Results
February
April
July
October
27
30
30
29
3M
Interim Report
and AGM
2015 HY
Results
Disclaimer and Safe Harbor
This FactBook contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than
statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins,
capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results.
By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions
which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this FactBook.
Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to
obtain necessary regulatory approvals or to obtain them on acceptable terms, 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, 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. Additionally, information contained
in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or
sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the
securities laws of such jurisdiction. UCB is providing this information as of the date of this FactBook and expressly disclaims any duty to update any
information contained in this FactBook, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will
be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be
subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products
after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the
reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
Contacts
Antje Witte
VP Investor Relations
Tel: +32 2 559 9414
E-mail: [email protected]
www.ucb.com
Investor FactBook FY2014
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