orion capital markets day 2017 · 7 18 may 2017 orion capital markets day 2017 orion today – year...
TRANSCRIPT
![Page 1: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/1.jpg)
Orion Capital Markets Day 2017
18 May 2017 Helsinki
![Page 2: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/2.jpg)
Orion’s century 1917-2017 Movie
Orion’s Strategy Timo Lappalainen, President & CEO
R&D update, part I Christer Nordstedt, SVP, Research & Development
Break
Specialty Products update Liisa Hurme, SVP, Specialty Products
Proprietary Products update Markku Huhta-Koivisto, SVP, Proprietary Products
Break
R&D update, part II Christer Nordstedt, SVP, Research & Development
Orion’s Financial Targets Jari Karlson, CFO
Closing remarks Timo Lappalainen, President & CEO
Lunch
18 May 2017 Orion Capital Markets Day 2017 2
Agenda
![Page 3: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/3.jpg)
This presentation contains forward-looking statements which involve risks and uncertainty factors.
These statements are not based on historical facts but relate to the Company’s future activities and
performance. They include statements about future strategies and anticipated benefits of these
strategies.
These statements are subject to risks and uncertainties. Actual results may differ substantially from
those stated in any forward-looking statement. This is due to a number of factors, including the
possibility that Orion may decide not to implement these strategies and the possibility that the
anticipated benefits of implemented strategies are not achieved. Orion assumes no obligation to update
or revise any information included in this presentation.
18 May 2017 Orion Capital Markets Day 2017 3
Disclaimer
![Page 4: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/4.jpg)
18 May 2017 Orion Capital Markets Day 2017 4
Orion’s century 1917-2017
Watch the film
![Page 5: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/5.jpg)
Orion’s centennial www.orion.fi/en/orion100
Orion Capital Markets Day 2017 5 18 May 2017
![Page 6: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/6.jpg)
Orion’s Strategy
Timo Lappalainen, President & CEO
![Page 7: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/7.jpg)
33%
47%
7%
4% 4% 5%
Sales split by business
Proprietary ProductsSpecialty ProductsAnimal HealthFermionContract manufacturingOrion Diagnostica
18 May 2017 Orion Capital Markets Day 2017 7
Orion today – year 2016 in figures
32%
16% 31%
8% 13%
Sales split by market area
FinlandScandinaviaOther EuropeNorth AmericaROW
Net sales 1,074 MEUR Operating profit 315 MEUR
Personnel 3 469
R&D investments 118 MEUR
6 production sites in Finland
Own sales unit in 26 European countries
![Page 8: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/8.jpg)
18 May 2017 Orion Capital Markets Day 2017 8
Orion has operations in 27 countries
Finland
-HQ
-Research & development
-Six production sites
-Sales unit
-Support functions
UK -Sales unit
-Research & development
Europe -Sales unit in 26 countries
India -Support functions
ROW - Global partner network
![Page 9: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/9.jpg)
18 May 2017 Orion Capital Markets Day 2017 9
Key developments 2014 to 2016
+ Easyhaler budesonide-formoterol combination
launches in Europe
+ 3 new projects in clinical developement pipeline
(darolutamide mHSPC, ODM-109, ODM-207)
+ MAA for Easyhaler salmeterol-fluticasone
combination product in Europe
+ New strategic research partnerships
– 3 development projects discontinued (ODM-106,
ODM-108, ODM-204)
– Expansion of Stalevo generic competition
– Generic threat to dexdor®
In 2017: New SVP, R&D appointed
+28 MEUR
+22 MEUR
Specialty
Products
+81 MEUR
-45 MEUR
-10 MEUR
![Page 10: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/10.jpg)
18 May 2017 Orion Capital Markets Day 2017 10
Orion’s strategy —
Mission to build well-being
![Page 11: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/11.jpg)
18 May 2017 Orion Capital Markets Day 2017 11
Orion’s values
Mutual
trust and
respect
Quality,
reliability
and safety
Customer
focus
Innovation Achievement
Orion people Building Well-being
![Page 12: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/12.jpg)
18 May 2017 Orion Capital Markets Day 2017 12
Proprietary Products back on growth track
-15%
-10%
-5%
0%
5%
10%
15%
20%
25%
30%
0
50
100
150
200
250
300
350
400
450
2012 2013 2014 2015 2016
EU
R m
illion
Other
Precedex
Simdax
Easyhaler
Dexdor
Comtan/ComtessStalevo
Growth,%
R&D Pipeline
![Page 13: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/13.jpg)
18 May 2017 Orion Capital Markets Day 2017 13
Steady sales growth for Specialty Products
0%
5%
10%
15%
20%
0
150
300
450
600
2012 2013 2014 2015 2016
EU
R m
illion
Net sales Growth, %
59% 16%
12%
13%
Finland
Scandinavia
Eastern Europe & Russia
ROW
Sales split 2016
Biosimilars
Gx
OTC
![Page 14: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/14.jpg)
18 May 2017 Orion Capital Markets Day 2017 14
Animal Health – something old, something new
-5%
0%
5%
10%
15%
0
25
50
75
100
2012 2013 2014 2015 2016
EU
R m
illion
Net sales Growth, %
R&D pipeline
Partners
![Page 15: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/15.jpg)
18 May 2017 Orion Capital Markets Day 2017 15
Fermion has an important strategic role
APIs for Orion’s proprietary products
Generic APIs for Orion and other pharmaceutical
companies
Contract development and
manufacturing -15%
0%
15%
30%
45%
0
20
40
60
80
2012 2013 2014 2015 2016
EU
R m
illion
Net sales* Growth, %
*) Excluding supply to Orion
![Page 16: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/16.jpg)
18 May 2017 Orion Capital Markets Day 2017 16
Contract manufacturing & other
-30%
-15%
0%
15%
30%
45%
0
10
20
30
40
50
2012 2013 2014 2015 2016
EU
R m
illion
Net sales Growth, %
Pharmaceutical manufacturing for other companies
Orion has special capacity e.g. in
hormonal gel products
![Page 17: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/17.jpg)
-10%
-5%
0%
5%
10%
15%
20%
0
10
20
30
40
50
60
2012 2013 2014 2015 2016
EU
R m
illion
Net sales
Operating profit
Sales growth, %
Operating profit margin
QuikRead GenRead
18 May 2017 Orion Capital Markets Day 2017 17
Orion Diagnostica
![Page 18: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/18.jpg)
Fermion’s new production facility
Easyhaler production capacity expansion
R&D
18 May 2017 Orion Capital Markets Day 2017 18
Investments for future growth
![Page 19: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/19.jpg)
Growing net sales more rapidly than
growth of the pharmaceuticals
market. Achievement of this objective
requires continuous investment in
development of the product portfolio.
> Maintaining profitability at a good
level. The aim is operating profit that
exceeds 25% of net sales.
≥ Keeping the equity ratio
at least 50%.
€ Distributing an annual dividend that
in the next few years will be at least
EUR 1.30 per share, and increasing
the dividend in the long term.
18 May 2017 Orion Capital Markets Day 2017 19
Orion’s financial objectives
![Page 20: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/20.jpg)
18 May 2017 Orion Capital Markets Day 2017 20
World pharma market development
![Page 21: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/21.jpg)
R&D review Part I
Christer Nordstedt
SVP, Research & Development
![Page 22: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/22.jpg)
Orion Capital Markets Day 2017 22
Previous Experience – Christer Nordstedt 1/2
1983 1990 1997 2000 2007 2011 2017
Academia
(MD, PhD, post-doc) Lab Head Various Vice President roles with increasing responsibilities
18 May 2017
![Page 23: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/23.jpg)
Previous Experience - Christer Nordstedt 2/2
Extensive experience of small molecule and
biologics (monoclonal antibodies and other
protein drugs)
Strong interest in translational aspects
(bringing basic research to practical patient use)
Extensive experience of partnering (in- and out
licensing, academic collaborations)
Primarily Discovery and Early Development
(through phase 2A/proof of concept) experience
but also phase 3 and Life cycle Management
Strong interest in combining therapeutics
and diagnostics and personalization of
treatments
18 May 2017 Orion Capital Markets Day 2017 23
![Page 24: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/24.jpg)
“The patient comes first!”
Mechanistic approach to diseases –
Understanding and targeting underlying
disease processes
Agnostic with regard to modalities – small molecules, biologics
and beyond
“The power of genetics” – Finland an excellent arena
for that type of research
Wearable technology and “digital biomarkers/ end-points”
18 May 2017 Orion Capital Markets Day 2017 24
Research Philosophy
![Page 25: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/25.jpg)
Orion Capital Markets Day 2017 25
Building the R&D future success
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Innovation system
Competence base
Therapy area work
Darolutamide
ODM-104
ODM-109
ORM-12741
ODM-203
Work for the future ongoing
Bringing treatments to patients addressing unmet needs also in
the future require capability to discover and develop less
validated targets, new treatment concepts and increasing
collaboration with academic partners
ODM-207
18 May 2017
ROADMAP
![Page 26: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/26.jpg)
18 May 2017 Orion Capital Markets Day 2017 26
R&D development portfolio is maturing and more confirmatory
programs expected in the portfolio
0
20
40
60
80
100
120
140
0
2
4
6
8
10
12
14
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
On hold
Confirmatoryphase
Exploratoryphase
*
M€
N o
f pro
jects
* non-probabilitized projections
![Page 27: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/27.jpg)
Orion Capital Markets Day 2017 27
On-going drug development projects at Orion R&D (May 2017)
Phase I Phase II Phase III Registr.
ODM-207
BET inhibitor
(solid tumors)
ORM-12741
α2C antagonist
(Alzheimer’s disease)
ODM-104 COMT inhib.
(Parkinson’s disease)
ODM-109 oral
levosimendan (ALS)
ODM-203 FGFR inhib.
(solid tumors)
Darolutamide
AR*-inhibitor
(prostate cancer,
nmCRPC**)
Darolutamide
AR-inhibitor
(prostate cancer,
mHSPC***)
EH Salmeterol/
Fluticasone
(asthma and COPD¥)
N = 4 N = 2 N = 1 N = 1
* Androgen receptor
** non-metastatic Castration Resistant Prostate Cancer
*** metastatic Hormone Sensitive Prostate Cancer ¥ Chronic Obstructive Pulmonary Disease
18 May 2017
![Page 28: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/28.jpg)
Orion Capital Markets Day 2017 28
Key clinical pharmaceutical development projects 1/2
More info about R&D projects at: http://www.orion.fi/en/rd/orion-rd/pipeline/
Project Indication PHASE Registration
Easyhaler® salmeterol-fluticasone Asthma, COPD Bioequivalence
study Registration
Darolutamide (ODM-201) 1) Prostate cancer (nmCRPC) I II III
Darolutamide (ODM-201) 1) Prostate cancer (mHSPC) I II III
Levosimendan 2) Low Cardiac Output Syndrome I II III
1) In collaboration with Bayer 2) Partner: Tenax Therapeutics, Inc. = Phase completed
= Phase ongoing
= Status changed
18 May 2017
![Page 29: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/29.jpg)
Orion Capital Markets Day 2017 29
Key clinical pharmaceutical development projects 2/2
More info about R&D projects at: http://www.orion.fi/en/rd/orion-rd/pipeline/
Project Indication PHASE Registration
ODM-109 (oral levosimendan) ALS I II
ORM-12741 (alpha-2c adrenoceptor antagonist) 3) Alzheimer’s disease I IIa
ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II
ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II
ODM-207 (BET protein inhibitor) Cancer I
3) In collaboration with Janssen Pharmaceuticals = Phase completed
= Phase ongoing
18 May 2017
![Page 30: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/30.jpg)
Orion Capital Markets Day 2017 30
R&D portfolio: Human proprietary projects
in research and development phase
Technic
al fe
asi
bilit
y
Pro
babilit
y o
f su
ccess
Low
H
igh
NDD
COMT-i ODM-104
Antiandrogen Darolutamide
Alpha2C ORM-12741
FGFR-i ODM-203
Pain
NDD
Pain Pain
BET-i ODM-207
Pain
Pain
Easyhaler
pipeline
Oncology
Levosimendan ODM-109
Low High Commercial potential
Oncology
Oncology
Oncology NDD
NDD
NDD
NDD = neurodegenerative disease
18 May 2017
![Page 31: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/31.jpg)
Orion Capital Markets Day 2017 31
Several academic and other collaborations both in early and late
phase of development
18 May 2017
![Page 32: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/32.jpg)
Salmeterol-fluticasone Easyhaler Easyhalers for treatment of asthma and COPD
18 May 2017 Orion Capital Markets Day 2017 32
![Page 33: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/33.jpg)
Orion Capital Markets Day 2017 33
Easyhaler® portfolio expanding
1994 Beclomet
Easyhaler®
(beclomethasone)
1993 Buventol
Easyhaler®
(salbutamol)
2004 Formoterol
Easyhaler®
(formoterol)
2002 Budesonide
Easyhaler®
(budesonide)
2014 Bufomix Easyhaler®
(budesonide-formoterol)
Salmeterol-fluticasone
Easyhaler®
Salmeterol-fluticasone Easyhaler® in
registration phase in Europe
Favorable bioequivalency study results
at the end of 2016
We have utilised the learnings from
budesonide-formoterol Easyhaler®
development which have significantly
increased our understanding of the
regulatory requirements
18 May 2017
![Page 34: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/34.jpg)
Darolutamide (ODM-201) A novel second generation androgen receptor (AR) inhibitor for the treatment of prostate cancer
In collaboration with Bayer
Orion Capital Markets Day 2017 34 18 May 2017
![Page 35: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/35.jpg)
Orion Capital Markets Day 2017 35
Darolutamide has a unique profile
Compound
AR
affinity
Ki (nM)
Antagonism IC50 (nM) Proliferation
VCaP
IC50 (nM) WT AR AR
(F876L)
AR
(T877A)
AR
(W741L)
Bicalutamide 12 150 218 957 Agonist
Enzalutamide 86 155 Agonist 296 >10000 400
Apalutamide (ARN-509) 68 168 Agonist 1130 >10000 300
Darolutamide 9 65 66 1782 1500 500
● Darolutamide blocks the function of androgen receptor in both biochemical and cell assays with equal
or better potency compared to enzalutamide and apalutamide
● Low likelihood for brain entry demonstrated in preclinical models
Enzalutamide 19%*
Apalutamide 29%* Darolutamide 3% **
*Refs. Clegg et al, 2012; Forster at al, 2011
** Rat autoradiography (QWBA confirms brain/plasma ratio of
14C-darolutamide related radioactivity was 0.04-0.06,
indicating negligible penetration to the brain)
Enzalutamide Apalutamide Darolutamide
18 May 2017
![Page 36: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/36.jpg)
18 May 2017 Orion Capital Markets Day 2017 36
Darolutamide Clinical studies
Study Phase Populations N Daily Dose
(mg) Status
ClinicalTrials.gov
identifier
ARADES I/II
mCRPC*
• Chemo/CYP17 naïve
• Post chemo/ CYP17 naïve
• Post CYP17
134 200-1800 Completed NCT01317641
ARADES ext II
mCRPC*
• Chemo/CYP17 naïve
• Post chemo/ CYP17 naïve
• Post CYP17
76 200-1800 Completed NCT01317641
ARAFOR I Chemo-naïve mCRPC* 30 1200 Ongoing NCT01784757
ARIADME I Healthy subjects 12 300 Completed NCT02418650
ARAMIS III nmCRPC** 1500 1200 Ongoing NCT02200614
ARASENS III mHSPC*** 1300 1200 Ongoing NCT02799602
* metastatic Castration Resistant Prostate Cancer
** non-metastatic Castration Resistant Prostate Cancer
*** metastatic Hormone Sensitive Prostate Cancer
![Page 37: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/37.jpg)
Orion Capital Markets Day 2017 37
Darolutamide showed significant and durable antitumour activity at clinical dose levels (phase I/II studies, mCRPC patients naïve for chemotherapy and CYP17-inhibitor, 1200, 1400, and 1800 mg bid)
PSA* % change from baseline Maximum PSA* % change from baseline
Each bar (left) or line (right) represents one subject.
Shore et al. European Urology Focus, 2017, online 14
February 2017
* Prostate-specific antigen
Median time to PSA* progression – 12 months (95%CI 6-18)
Subject in study at cut-off
Subject discontinued study
18 May 2017
![Page 38: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/38.jpg)
● nmCRPC patients who are at high risk for
developing metastatic disease are included
● Primary endpoint
– Darolutamide over placebo in metastasis-free
survival (MFS)
● Secondary endpoints
– Overall survival, time to first symptomatic
skeletal event (SSE), time to first initiation of
cytotoxic chemotherapy, time to pain
progression, and to characterize the safety and
tolerability of darolutamide
● The study is proceeding as planned with
estimated completion in 2018
18 May 2017 Orion Capital Markets Day 2017 38
Darolutamide Phase III study ongoing in
non-metastatic castration resistant prostate cancer (nmCRPC)
ClinicalTrials.gov identifier:
NCT02200614
![Page 39: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/39.jpg)
● mHSPC patients candidate for ADT (hormonal therapy) and
docetaxel (chemotherapy) are included. Treatment
Darolutamide with ADT and six cycles of docetaxel
● Primary endpoint
– Darolutamide over placebo in overall survival
● Secondary endpoints
– Time to castration resistance, time to antineoplastic
therapy, time to first symptomatic skeletal event, time
to initiation of opioids, time to pain progression, and to
characterize the safety and tolerability of darolutamide
● The study is proceeding as planned with estimated
completion in 2022
18 May 2017 Orion Capital Markets Day 2017 39
Darolutamide Phase III study ongoing in
metastatic hormone sensitive prostate cancer (mHSPC)
ClinicalTrials.gov identifier:
NCT02799602
![Page 40: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/40.jpg)
ODM-203 A unique and selective dual FGFR+VEGFR inhibitor for FGFR-dependent tumors
Orion Capital Markets Day 2017 40 18 May 2017
![Page 41: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/41.jpg)
41
Rationale for combining FGFR* and VEGFR** inhibition
Constitutively active FGFRs are oncogenic in non-clinical studies
Both VEGFR and FGFRs are drivers for angiogenesis, a hallmark of tumorigenesis
FGFR amplifications have an impact on patient survival in studied cancer types (breast, lung, and gastric)
VEGFR expression correlates with survival or progression in tumor types with high incidence of FGFR alterations (bladder, breast, lung, gastric)
FGFR signaling is a known escape mechanism for anti-VEGFR treatments
Orion Capital Markets Day 2017
* Fibroblast Growth Factor Receptor
** Vascular Endothelial Growth Factor Receptor
18 May 2017
![Page 42: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/42.jpg)
18 May 2017 Orion Capital Markets Day 2017 42
Angiogenic indications with altered FGFR* signalling
Tumor type Genomic alterations of FGFRs and FGFs
Breast (luminal) ~35% (FGFR1 amp, FGFR2 amp, FGFR4 amp, FGFs)
NSCLC-SCC ~20% (FGFR1 amp, FGFR2 amp)
Bladder (invasive) ~15% (FGFR3 fusions, FGFR1 amp, FGFs)
Prostate ~14% (FGFR1 amp, FGFR2&3 fusions)
Colorectal ~10% (FGFR1 amp, FGFR3 mut)
Endometrial ~10% (FGFR2 mut)
Gastric ~7% (FGFR2 amp)
Renal ~6% (FGFR4 amp)
* Fibroblast Growth Factor Receptor
![Page 43: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/43.jpg)
18 May 2017 Orion Capital Markets Day 2017 43
ODM-203 is the only equally balanced selective dual FGFR*/VEGFR**
inhibitor
No FGFR* inhibitors on
the market
• ODM-203 has very high kinase selectivity against FGFR1-4 and VEGFR1-3
• Equally balanced inhibition may provide better efficacy/safety profile
In vitro kinase activity Cell based activity
Ratio ODM-203 Lucitanib
FGFR1/VEGFR2 1:1 1:6
Cell line (receptor), Ratio ODM-203 Lucitanib
FGFR/Angiogenesis 1:2 1:100
* Fibroblast Growth Factor Receptor
** Vascular Endothelial Growth Factor Receptor
![Page 44: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/44.jpg)
Orion Capital Markets Day 2017 44
ODM-203 Best tumour response (RECIST*) in KIDES study
Patients were generally not
selected by molecular
screening and tumor genetic
profiling data are incomplete
• 5 partial responses with
durable stable disease in a
number of other patients.
• 2 patients have received
ODM-203 treatment for >1
year
• Reductions in target lesions
were seen in patients with
significant FGFR genetic
aberrations as well as in
patients with VEGFR-
sensitive tumors without
FGFR genetic aberration From poster by P. Bono et al., presented at The Cholangiocarcinoma Foundation Annual meeting,
1-3 Feb 2017, Salt Lake City, Utah
* Response evaluation criteria in solid tumours 18 May 2017
![Page 45: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/45.jpg)
● The trial is investigating
– Safety and tolerability of ODM-203 in subjects with advanced solid tumours
– Efficacy of ODM-203 in slowing the growth of solid cancerous tumours in patients in which FGFR
changes in cancerous tumours have been detected
18 May 2017 Orion Capital Markets Day 2017 45
ODM-203 – current status
ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II
KIDES trial with Phase II expansion ongoing
ClinicalTrials.gov identifier: NCT02264418
![Page 46: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/46.jpg)
ODM-207 Unique BET inhibitor for solid tumors
18 May 2017 Orion Capital Markets Day 2017 46
![Page 47: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/47.jpg)
● BET proteins occupy regulatory elements
of DNA (superenhancers) in many key
oncogenes
– They increase the expression target
oncogenes
● BET target genes include: Myc, MycN
18 May 2017 Orion Capital Markets Day 2017 47
Target: BET proteins which regulate expression of oncogenes
ODM-207
• Binds to BET proteins
• Inhibits transcription of key oncogenes
such as Myc and MycN in many cancers
![Page 48: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/48.jpg)
18 May 2017 Orion Capital Markets Day 2017 48
ODM-207 – A unique BET* inhibitor for solid tumours
Good physico-
chemical properties
Patent applications
filed
Structure different than
JQ1** derivatives
ODM-207
Potent and selective
BET* inhibitor
Phase I ongoing
ODM-207 is an investigational small molecule that has a unique chemical structure designed
to block the growth of cancer cells through potent and selective inhibition of BET* family
proteins. In preclinical studies, ODM-207 has shown antiproliferative effects in several
haematological and solid tumour cell lines.
* Bromodomain and Extra-Terminal
** JQ1 is a BET inhibitor reference compound
![Page 49: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/49.jpg)
18 May 2017 Orion Capital Markets Day 2017 49
ODM-207 inhibits the tumour growth in enzalutamide-resistant 22Rv1
prostate cancer xenograft
Effect of ODM-207 on tumour volumes
ODM-207 inhibits Myc in in vivo efficacy study
Effect of ODM-207 on tumour weights
From poster Björkman et al., presented in
EORTC-NCI-AACR in 11-12/2016
![Page 50: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/50.jpg)
● The trial is investigating
– PK, safety and tolerability, and antitumour activity of ODM-207 in subjects with
advanced solid tumours
Orion Capital Markets Day 2017 50
ODM-207 – current status
ClinicalTrials.gov identifier: NCT03035591
18 May 2017
ODM-207 (BET protein inhibitor) Cancer I
BETIDES phase I/II trial ongoing
![Page 51: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/51.jpg)
Specialty Products –strong offering of generic prescription drugs, biosimilars and self-care
Liisa Hurme
Senior Vice President, Specialty Products
Chairman of the Board, Fermion Oy
![Page 52: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/52.jpg)
SpP Key figures from 2016
0
100
200
300
400
500
600
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
EU
R m
illion
~2 300 MAs
~3 400 SKUs
Net sales EUR 508 million
18 May 2017 Orion Capital Markets Day 2017 52
Specialty Products division has generated steady sales growth
![Page 53: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/53.jpg)
Breakdown of SpP (Gx & OTC) net
sales by geographic area 2016
59% 16%
12%
4% 9%
Finland
Scandinavia
Eastern Europe
Other Europe
Other countries
71%
21%
8%
Gx OTC Biosimilars
Breakdown of SpP net sales by
Business Units 2016
18 May 2017 Orion Capital Markets Day 2017 53
Generic Presciption Drugs and Nordics in Focus
![Page 54: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/54.jpg)
Generic Prescription Drugs
18 May 2017 Orion Capital Markets Day 2017 54
![Page 55: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/55.jpg)
● Nordic region is Orion’s home base for generic
products
● In Finland, Orion continues to be the leading
generics player with 42% market share
● Orion is growing faster than the market
in Nordics, Poland and Russia
● Orion holds a significant market share in
neurology and psychiatry in Poland
18 May 2017 Orion Capital Markets Day 2017 55
SpP Gx business has outperformed market growth
Scandinavia Orion
+9% +38% Finland Orion
+8% +14%
Russia Orion
+11% +19% Poland Orion
+0% +6%
Leading generic
company in Finland
Leading company
in OTC in Finland
Source: QuintilesIMS - MIDAS, Gx and biosimilar sales growth 2016 vs. 2015 in EUR, except Russia in RUB
Orion is one of the Top 3 generic
companies in Scandinavia
![Page 56: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/56.jpg)
Recent Changes in the Finnish Pharmaeutical Market
● Price band decreased from EUR 1.5 to EUR 0.5
● Inclusion of the parallel imported (PI) products into
the reference pricing category
● Estimated Gx market market growth
in Finland 4.3% between 2017-2021 (BMI, Q1-2017)
Orion +14%
Teva/ Ratiopharm
+1%
Sandoz/ Hexal +4%
Pfizer +20%
Takeda -10%
All others +4%
Finland generics & biosimilars market in 2016
18 May 2017 Orion Capital Markets Day 2017 56
Recent changes in Finland will have an effect on market value
Source: QuintilesIMS-MIDAS, Gx and biosimilar sales growth 2016 vs 2015 in EUR
Orion’s position in Finland is strong
![Page 57: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/57.jpg)
€0.00
€0.50
€1.00
€1.50
€2.00
€2.50
€3.00
Price corridor prior 2017
Reimbursed category I* Reimbursed category II**
Not reimbursed
Brand A, EUR X (sets the floor)
57
Change in Finnish reimbursement system for generic prescription drugs
Brand B, EUR X + 0.49 Brand C, EUR X + 0.60
Brand D, EUR X + 1.49
*) Price/package <EUR 40.0
**) Price/package ≥EUR 40.0
Brand E, EUR X + 1.75
Brand F, EUR X + 2.25
€0.00
€0.50
€1.00
€1.50
€2.00
€2.50
€3.00
Price corridor 1.1.2017
Reimbursed Not reimbursed
Brand A, EUR X (sets the floor)
Brand B, EUR X + 0.49
Brand C, EUR X + 0.60
Brand D, EUR X + 1.49
Brand E, EUR X + 1.75
Brand F, EUR X + 2.25
18 May 2017 Orion Capital Markets Day 2017
![Page 58: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/58.jpg)
Sandoz/ Hexal +5%
Orion +38%
Allergan -9%
Orifarm +16%
Teva/ Ratiopharm
-11%
All others +11%
Scandinavia generics & biosimilars market in 2016 was + 9 % from 2015
Sandoz/ Hexal +4%
Orion +67%
Takeda +9%
Orifarm +14% GSK +6%
All others -1%
Denmark generics & biosimilars market in 2016 was + 8% from 2015
18 May 2017 Orion Capital Markets Day 2017 58
Orion is one of the fastest growing Gx companies in Scandinavia
Source: QuintilesIMS-MIDAS, Gx and biosimilar sales growth 2016 vs 2015 in EUR
![Page 59: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/59.jpg)
0%
2%
4%
6%
8%
10%
12%
14%
16%
CAG
R 2
014-2
016
Market volume and value growth by market type
Gx volume
GX & BSvolume
Gx value
Gx & BSvalue
0%
50%
100%
150%
200%
250%
CAG
R 2
014-2
016
Market volume and value growth by market type
Gx volume
BS volume
Gx value
BS value
18 May 2017 Orion Capital Markets Day 2017 59
Biosimilars are driving the market growth
Source: QuintilesIMS-MIDAS, Gx and biosimilar sales 2014-2016
![Page 60: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/60.jpg)
Self Care Business
18 May 2017 Orion Capital Markets Day 2017 60
![Page 61: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/61.jpg)
0
10
20
30
40
50
60
2013 2014 2015 2016
EU
R m
illion
Orion OTC market sales in Finland
Medicinal Non-medicinal
0
50
100
150
200
250
2013 2014 2015 2016
EU
R m
illion
Total OTC market sales in Finland
Medicinal Non-medicinal
18 May 2017 Orion Capital Markets Day 2017 61
The non-medicinal market is growing as people are more health conscious
Source: QuintilesIMS-InformX, 2017
![Page 62: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/62.jpg)
Biosimilar Business
18 May 2017 Orion Capital Markets Day 2017 62
![Page 63: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/63.jpg)
0
20
40
60
80
100
120
140
160
Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4
2013 2014 2015 2016
Infl
ixim
ab v
olu
me (
SU
)
Infliximab volume development in the Nordics
010
20
304050
60
7080
EU
R m
illion
Total market value has not increased
2014
2015
2016
18 May 2017 Orion Capital Markets Day 2017 63
Infliximab use has expanded in Nordics with biosimilar entries
Infliximab
volume
Volume growth %
2016 vs. 2015
Finland 22%
Sweden 9%
Denmark 32%
Norway 23%
Scandinavia 20%
Nordics 20%
Source: QuintilesIMS-MIDAS, 2017
![Page 64: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/64.jpg)
0
5
10
15
20
25
30
35
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2013 2014 2015 2016
EU
R m
illion
Biosimilar infliximab value growth in Nordics
Finland
Denmark
Sweden
Norway
18 May 2017 Orion Capital Markets Day 2017 64
Biosimilar infliximab volume growth in Nordics 2016 vs. 2015 was 114%
Biosimilar
infliximab
Volume growth %
2016 vs. 2015
Finland 233%
Sweden 374%
Denmark 88%
Norway 70%
Scandinavia 98%
Nordics 114%
![Page 65: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/65.jpg)
NOR DEN SWE FIN Nordics
Q414 21% 0% 0% 0% 4%
Q415 63% 96% 12% 1% 37%
Q416 1% 100% 24% 34% 43%
0%
20%
40%
60%
80%
100%
Remsima MS% development of infliximab value
Orion Capital Markets Day 2017
Remsima commercialisation timelines and market shares
2014 2015 2016 2017
Finland
Others (Estonia, Iceland)
Norway LIS
Denmark (Amgros)
Sweden
Source: QuintilesIMS-MIDAS, 2017 18 May 2017 65
![Page 66: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/66.jpg)
0%2%4%6%8%
10%12%14%
of
tota
l G
x s
ale
s
Market share development of Orion Gx
2009 2015 2016
18 May 2017 Orion Capital Markets Day 2017 66
Positive outlook in all markets with challenges in Finland
Source: QuintilesIMS-MIDAS, 2017, includes Gx and biosimilars
Source: BMI, Q12017, in local currency
Finland 478
Sweden 613
Denmark 453
Norway 282
Poland 2370
Gx market size in 2016 (MEUR) Gx
Market
Growth
2017-2021
Finland +4.3%
Sweden +3.4%
Poland +6.3%
Russia +8.7%
![Page 67: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/67.jpg)
Focus on
current
Geographic
Territory
with
Expansion to
selected
countries
when
feasible
OTC Products: Keep the market share in Finlands and grasp the non-medicinal market trend with new products and
product lines
Generic Prescription Drugs: Ensure constant renewal and competitiveness of the porfolio in key markets
Biosimilars: Establish a solid existence in Nordics
18 May 2017 Orion Capital Markets Day 2017 67
Specialty Products continue with three businesses …..
![Page 68: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/68.jpg)
Proprietary Products
Markku Huhta-Koivisto
SVP, Proprietary Products
![Page 69: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/69.jpg)
42%
28%
27%
3%
Sales of Orion’s branded Parkinson drugs by market area MAT12/2016*
Europe
Japan
ROW
USA
18 May 2017 Orion Capital Markets Day 2017 69
Parkinson’s drugs
*Source: IMS Health sales statistics MAT12/2016
0
10
20
30
40
50
60
Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1
2013 2014 2015 2016 17
EU
R m
illion
Orion sales Deliveries to Novartis
![Page 70: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/70.jpg)
0
10
20
30
40
50
60
70
80
2013 2014 2015 2016
EU
R m
illion
Stalevo
Comtan
0
20
40
60
80
100
120
140
160
2013 2014 2015 2016
EU
R m
illion
LCE Others
LCE Orion
Stalevo
18 May 2017 Orion Capital Markets Day 2017 70
Parkinson’s drugs in key areas
Entacapone sales in Japan LCE* product sales in EU5
Source: QuintilesIMS Source: QuintilesIMS
*) LCE = levodopa/carbidopa/entacapone
![Page 71: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/71.jpg)
0
10
20
30
40
50
60
70
2013 2014 2015 2016
EU
R m
illion
LCE Others
LCE Orion
Stalevo
18 May 2017 Orion Capital Markets Day 2017 71
Parkinson’s drugs in key areas, different dynamics
LCE* product sales in Germany
Source: QuintilesIMS *) LCE = levodopa/carbidopa/entacapone
![Page 72: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/72.jpg)
0
5
10
15
20
25
30
2013 2014 2015 2016
EU
R m
illion
LCE* product sales in Spain
Stalevo LCE Orion LCE Others
18 May 2017 Orion Capital Markets Day 2017 72
Parkinson’s drugs in key areas, different dynamics
0
5
10
15
20
25
30
35
40
2013 2014 2015 2016EU
R m
illion
LCE* product sales in France
Stalevo LCE Orion LCE others
0
5
10
15
20
2013 2014 2015 2016
EU
R m
illion
LCE* product sales in Italy
Stalevo LCE Orion LCE others
Source: QuintilesIMS Source: QuintilesIMS Source: QuintilesIMS
*) LCE = levodopa/carbidopa/entacapone
![Page 73: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/73.jpg)
18 May 2017 Orion Capital Markets Day 2017 73
Easyhaler update
Bufomix Available strengths:
80/4.5 &160/4.5 µg/inhal 320/4.5 µg/inhal
Co-marketing deal with Menarini
Marketing deal with Hikma in Middle East North-Africa region
MA in 27 countries
Orion is launching in Germany and will be launching in UK and in
France 2017
Easyhaler salmeterol-fluticasone combination product filed
Evaluation for new products going on
Discussions for several new markets are on going
02468
101214161820
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1
2012 2013 2014 2015 2016 17
EU
R m
illion
Easyhaler net sales, 2016 growth +24%
Bufomix Others
![Page 74: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/74.jpg)
SWEDEN
HUNGARY
DENMARK
BELGIUM
FINLAND
POLAND
SPAIN
ITALY OTHER EUROPE
18 May 2017 Orion Capital Markets Day 2017 74
Bufomix Easyhaler Total sales in 2016: EUR 26.5 million (+72%)
![Page 75: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/75.jpg)
MA granted in the 1st DCP 160/4.5 and 320/9 µg/dose
Countries withdrawn from
the 1st DCP / National
process in Switzerland
No MAs applied yet
MA = Marketing Authorization
18 May 2017 Orion Capital Markets Day 2017 75
Budesonide-formoterol Easyhaler Outcome of the 1st wave DCPs / National registrations
![Page 76: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/76.jpg)
80/4,5 µg/dose: 23 1st wave countries,
1st MAs Q2/2016,
1st launches Q2-Q3/2016 • DK, SE, FI, CZ, IE launched
Netherlands: MA granted
02/2016, launched 05/2016
Germany: MA granted 11/2016
Launch phase on going
France: DCP ended
successfully 12/2016,
national MA pending
UK: MA Granted 01/2017,
Launch 2017
MAs granted in the DCPs
No MAs applied yet
18 May 2017 Orion Capital Markets Day 2017 76
Budesonide-formoterol Easyhaler Outcome of the 2nd wave DCPs / National registrations
MA = Marketing Authorization
![Page 77: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/77.jpg)
88%
8%
3% 1%
Turbuhaler (AZ)
Spiromax (Teva)
Easyhaler (Orion)
Elpenhaler (Elpen)
18 May 2017 Orion Capital Markets Day 2017 77
Budesonide/formoterol combination sales in Europe by inhaler device Total market in 2016: EUR 1.03 billion (-7%)
Source: QuintilesIMS
![Page 78: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/78.jpg)
0
20
40
60
80
100
2014 2015 2016
EU
R m
illion
Gx sales in Europe
Spiromax(Teva)
Easyhaler(Orion)
Elpenhaler(Elpen)
0
200
400
600
800
1,000
1,200
1,400
2014 2015 2016
EU
R m
illion
Turbuhaler sales in Europe
18 May 2017 Orion Capital Markets Day 2017 78
Budesonide/formoterol dry powder inhaler sales in Europe Total Gx sales in 2016: EUR 119 million
Source: QuintilesIMS Source: QuintilesIMS
![Page 79: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/79.jpg)
60%
32%
4% 2%
1% 1% 0% Diskus (GSK)
Evohaler (GSK)
Sirdupla (Mylan)
Poland Diskus generics
Forspiro (Sandoz)
Elpenhaler (Elpen)
Salmeterol/Fluticasone MDI (Cipla)
18 May 2017 Orion Capital Markets Day 2017 79
Salmeterol/fluticasone combination sales in Europe by inhaler device Total market in 2016: EUR 1.3 billion mnf (-20%)
Source: QuintilesIMS
![Page 80: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/80.jpg)
93%
3% 2% 2%
DPI total market in 2016: 838 m€ (-19%)
Diskus (GSK)
Poland Diskusgenerics
Forspiro(Sandoz)
Elpenhaler(Elpen)
89%
10%
1%
MDI total market in 2016: 471 m€ (-21%)
Evohaler (GSK)
Sirdupla (Mylan)
Salmeterol/FluticasoneMDI (Cipla)
18 May 2017 Orion Capital Markets Day 2017 80
Salmeterol/fluticasone combination sales in Europe
Source: QuintilesIMS Source: QuintilesIMS
DPI = Dry Powder Inhaler MDI = Metered Dose Inhaler
![Page 81: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/81.jpg)
0
5
10
15
20
25
30
2014 2015 2016
EU
R m
illion
DPI Gx sales in Europe: total sales in 2016 EUR 57 million
Poland Diskusgenerics
Forspiro(Sandoz)
Elpenhaler(Elpen)
0
200
400
600
800
1,000
1,200
2014 2015 2016
EU
R m
illion
DPI Diskus sales in Europe
18 May 2017 81
Salmeterol/fluticasone dry powder inhaler (DPI) sales in Europe
Orion Capital Markets Day 2017
Source: QuintilesIMS Source: QuintilesIMS
![Page 82: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/82.jpg)
Sales in Europe 2016 EUR 45 million (+14.5%)
Italy
Germany
Austria
Finland
Spain
Other
18 May 2017 Orion Capital Markets Day 2017 82
Simdax Update
+13% +16%
+9%
+15%
+1%
+30%
Sales outside Europe EUR 11 million
Orion is in the pole position in critical care with
significant Share of Voice within the medical society
• Partnership with key European societies including
European Society of Cardiology (ESC) and European
Society of Intensive Care Medicine (ESICM)
• Major sponsor of 7-9 international congresses
annually
• Sponsor of international education programs of AHF
(Acute Heart Failure) and PAD (Pain, Agitation and
Delirium) management in intensive care
• Endorsing new clinical studies in the field in
collaboration with key European hospitals
Source: QuintilesIMS
![Page 83: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/83.jpg)
18 May 2017 Orion Capital Markets Day 2017 83
Simdax poses growth opportunities in all
European markets and new partner territories
No new head-to-head competitors expected in any of
the SIMDAX segments during the formulation patent
validity period until September 2020
Major investment in marketing and sales with novel
multichannel opportunities including digital education
New clinical study underway in cardiology to support
repetitive use in AHF
Significant growth captured in territories with recent
SIMDAX introductions including France, Belgium,
Denmark and Poland
New licensing agreements signed for China and Korea
![Page 84: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/84.jpg)
Dexdor in-market sales in Europe 2016
Italy
Germany
Austria
Sweden
Spain
Other
18 May 2017 Orion Capital Markets Day 2017 84
Dexdor Update
+32%
+76%
+112%
+4% +9%
+42%
Precedex sales 2016 EUR 222 million (+14%)
Source: QuintilesIMS
0
5
10
15
20
Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1
2013 2014 2015 2016 17
EU
R m
illion
Dexdor sales
European Sedative Market 2016
Propofol
Midazolam
Remifentanil
Dexmedetomidine
EUR 342 million
EUR 69 million
EUR 64 million
EUR 48 million
-1%
-9%
-5%
+34%
Source: QuintilesIMS
![Page 85: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/85.jpg)
● Orion is the major sponsor of European wide
educational program ESICM-NEXT LIVES
accommodating 100 doctors in key hospitals
during 2017-2018
● Multiple international educational events and
digital education provided for doctors and nurses
about disease management in the ICU
● Endorsing new clinical studies in the field in
collaboration with key European hospitals
● Orion has become aware that generic
competition of Dexdor® has started due to the
launch of generic version of the product by a
competitor in the German market. Orion is
continuing actions to defend its rights.
18 May 2017 Orion Capital Markets Day 2017 85
Dexdor getting well-established in intensive care unit (ICU)
![Page 86: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/86.jpg)
18 May 2017 Orion Capital Markets Day 2017 86
Partnership examples D
aro
luta
mid
e
•A potent and full AR antagonist – differentiated from other AR-targeted therapies
•Orion responsible for manufacturing
•Orion has the option to co-promote darolutamide in Europe and is eligible to receive substantial royalties on the product sales
•Two phase III programs ongoing
•Metastatic HSPC
•Non-metastatic CRPC
ORM
-12741
•Alpha-2c adrenoceptor antagonist
•Orion and Janssen will co-fund the development after on-going Phase IIa study
•Orion will be eligible to receive milestone payments upon successful completion of certain events, as well as royalties on future sales.
•Orion will have exclusive commercialization rights in Europe.
Global partnership for the
development & commercialisation
of darolutamide
License agreement for the
development and
commercialisation of ORM-12741
Prostate cancer Symptoms of Alzheimer’s disease
![Page 87: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/87.jpg)
R&D pipeline review Part II
Christer Nordstedt
SVP, Research & Development
![Page 88: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/88.jpg)
ORM-12741 Alpha-2C adrenoceptor antagonist for symptomatic treatment of Alzheimer’s disease
In collaboration with Janssen
18 May 2017 Orion Capital Markets Day 2017 88
![Page 89: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/89.jpg)
● Highly potent and selective alpha-2C
adrenoceptor antagonist
● Rodent models predict beneficial effects on
cognition and neuropsychiatric symptoms (NPS)
● Phase 1 studies (healthy subjects)
– Possible to administer orally
– Well tolerated
– Displacement of an alpha-2C PET tracer
● Phase 2a study in Alzheimer’s disease patients
– Positive signals of efficacy in
– Episodic and working memory
– Neuropsychiatric symptoms
Orion Capital Markets Day 2017 89
ORM-12741
Impro
vem
ent
Quality of Memory
Baseline
1 hour after
dosing (30 mg)
18 May 2017
![Page 90: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/90.jpg)
Objectives
To evaluate efficacy of ORM-12741 on agitation & aggression and other neuropsychiatric symptoms
To evaluate efficacy of ORM-12741 on cognitive performance
To evaluate safety
Design and methodology
Randomised, double-blind, placebo-controlled, parallel-group, Phase 2 study
Patients with mild to moderately severe Alzheimer’s disease
2 dose levels of ORM-12741 and placebo
Sample size
100/group = ~300
● New formulation improving pharmacokinetic (PK) properties of ORM-12741 is used in the ongoing
Phase 2a study
18 May 2017 Orion Capital Markets Day 2017 90
Phase 2 study on efficacy of ORM-12741 in AD
ClinicalTrials.gov identifier: NCT02471196
ORM-12741 (alpha-2c adrenoceptor antagonist) Alzheimer’s disease I IIa
![Page 91: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/91.jpg)
ODM-104 New COMT-Inhibitor for Parkinson’s Disease
18 May 2017 Orion Capital Markets Day 2017 91
![Page 92: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/92.jpg)
● Levodopa is the most effective medicine for treating Parkinson’s disease (PD)
● As PD progresses, most people will eventually require the use of levodopa (85% of PD patients receive
levodopa)
● However, like all medicines, levodopa is not perfect – short acting levodopa can lead to motor
complications
● Longer acting levodopa with more stable plasma concentrations is an unmet need for PD treatment
Orion Capital Markets Day 2017 92
Treatment of Parkinson’s disease with levodopa
Short acting levodopa
Dyskinesia
Wearing-off
Too much levodopa
can cause involuntary
movements
Effect of levodopa
can fade and PD
symptoms can return
18 May 2017
![Page 93: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/93.jpg)
18 May 2017 Orion Capital Markets Day 2017 93
Levodopa elimination can be reduced and treatment effect improved
by inhibiting breakdown enzymes AADC and COMT
Brain Body
Dopamine
Levodopa
Dopamine
ODM-104
Carbidopa
COMT-i
Long-
acting
levodop
a AADC-i
Levodopa
3-OMD (inactive)
CO
MT
A
AD
C
AADC = Aromatic amino acid decarboxylase COMT = Catechol-O-methyltransferase 3-OMD = 3-O-Methyldopa
![Page 94: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/94.jpg)
● In phase I, ODM-104 has been in well tolerated and superior to entacapone by improving COMT
inhibition and levodopa pharmacokinetics in man
● Optimized carbidopa component further improves ODM-104 effect with double action on levodopa PK -
levodopa exposure (AUC*) increased over 30% when compared to entacapone
● Phase II: ODM-104/optimized carbidopa/long-acting levodopa will be compared with Stalevo®
(levodopa/carbidopa/entacapone combination) in PD patients with end-of-dose wearing-off symptoms
The Phase 2 study is ongoing
Orion Capital Markets Day 2017 94
New COMT-inhibitor ODM-104 for Parkinson’s disease treatment
ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II
* Area Under the Curve
18 May 2017
ClinicalTrials.gov identifier: NCT02764125
![Page 95: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/95.jpg)
● The target indication of ODM-104 is Parkinson´s disease with end-of-dose motor fluctuations - the
same as the currently approved indications of Comtess®/Comtan® and Stalevo®. Patients on
levodopa/AADC inhibitor treatment with or without entacapone can be directly switched to the new
combination product (ODM-104/optimized carbidopa/long-acting levodopa).
Orion Capital Markets Day 2017 95
Target indication
ODM-104 +
levodopa + carbidopa
Levodopa + carbidopa
Levodopa + carbidopa + Comtess® / Comtan®
(entacapone)
Stalevo® (levodopa + carbidopa + entacapone)
18 May 2017
![Page 96: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/96.jpg)
ODM-109 Oral levosimendan
Best symptomatic treatment for Amyotrophic Lateral Sclerosis (ALS)
Orion Capital Markets Day 2017 96 18 May 2017
![Page 97: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/97.jpg)
● Orphan disease with prevalence of
~1 patient/25 000
● Degeneration of motoneuron leads to skeletal
muscle weakness including diaphragm
● Causes premature death (3 years median survival
time from symptom onset)
● Decreases Quality of Life of both patient and
caregiver
● No symptomatic treatments for muscle function
available
18 May 2017 Orion Capital Markets Day 2017 97
Amyotrophic lateral sclerosis - ALS
Picture from: ALS Foundation for life
http://www.alsfoundation.org/learn/
A clear unmet need in ALS for a drug that improves
diaphragm/skeletal muscle function and endurance
![Page 98: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/98.jpg)
Levosimendan enhances force generation of diaphragm muscle fibers obtained from a rat model of heart failure and from COPD and non-COPD patients (ex vivo experiments)
Levosimendan improves human diaphragm function in healthy subjects in vivo
Levosimendan show a positive effect on skeletal muscle function (endurance) in Myasthenia Gravis rat model functionally mimicking ALS
18 May 2017 Orion Capital Markets Day 2017 98
Data supporting development of ODM-109 for ALS
By increasing skeletal muscle force and endurance, levosimendan has potential to
improve respiratory function, muscle fatigue and QoL* in ALS patients
*)QoL = Quality of Life
![Page 99: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/99.jpg)
● The first phase II study aimed to demonstrate beneficial effects on respiratory function
● Double-blind, cross-over design with 3 treatment periods
● Cross-over part of the study is followed by an open-label part for 6 months – an opportunity to study
long term effects
● The cross-over part of Phase II clinical trial with orally administered levosimendan (ODM-109) for
treatment of patients with ALS has been completed
● Although the trial did not achieve its primary objective, the findings were, however, promising
● Based on the findings, we are planning to continue the development programme
Orion Capital Markets Day 2017 99
LEVALS phase II study - levosimendan in ALS patients
18 May 2017
ODM-109 (oral levosimendan) ALS I II
![Page 100: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/100.jpg)
Orion: a company with the brain power and muscle of Big Pharma but with the agility of small biotech
Through internal work and partnering activities build and maintain a balanced pipeline that can deliver clinically meaningful differentiation/patient benefit long-term
Being a preferred partner for Big Pharma, Biotech and Academia
Making Orion capable of delivering novel proprietary small molecule therapeutics and biologics
Increase Orion’s visibility within the academic community and being capable of recruiting and retaining “the best and the brightest”
Being a significant contributor to the global scientific community
18 May 2017 Orion Capital Markets Day 2017 100
Vision for the future
![Page 101: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/101.jpg)
Competition for academic research groups in Finland 2017
www.orion.fi/en/Oriontation100
![Page 102: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/102.jpg)
Financial Targets
Jari Karlson
CFO
![Page 103: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/103.jpg)
18 May 2017 Orion Capital Markets Day 2017 103
Orion’s strategy —
Mission to build well-being
![Page 104: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/104.jpg)
Growing net sales more rapidly than
growth of the pharmaceuticals
market. Achievement of this objective
requires continuous investment in
development of the product portfolio.
> Maintaining profitability at a good
level. The aim is operating profit that
exceeds 25% of net sales.
≥ Keeping the equity ratio
at least 50%.
€ Distributing an annual dividend that
in the next few years will be at least
EUR 1.30 per share, and increasing
the dividend in the long term.
18 May 2017 Orion Capital Markets Day 2017 104
Orion’s financial objectives
![Page 105: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/105.jpg)
Where are we now?
18 May 2017 Orion Capital Markets Day 2017 105
![Page 106: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/106.jpg)
18 May 2017 Orion Capital Markets Day 2017 106
Steady development despite patent expiries
-2%
0%
2%
4%
6%
8%
0
200
400
600
800
1,000
1,200
2012 2013 2014 2015 2016
EU
R m
illion
Net sales
Parkinson franchise + Precedex
Other products
Growth, %
24%
25%
26%
27%
28%
29%
30%
31%
0
50
100
150
200
250
300
350
2012 2013 2014 2015 2016
EU
R m
illion
Operating profit
Operating profit
Operating profit margin
![Page 107: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/107.jpg)
18 May 2017 Orion Capital Markets Day 2017 107
44%
35%
7%
5% 3%
5%
Sales by business 2011
Proprietary Products Specialty ProductsAnimal Health FermionContract manufacturing & other Orion Diagnostica
33%
47%
7%
4% 4% 5%
Sales by business 2016
0
200
400
600
800
1,000
1,200
2012 2013 2014 2015 2016
EU
R m
illion
Net sales
…and despite major change in product portfolio
![Page 108: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/108.jpg)
32%
16% 31%
8%
13%
By market area in 2016
Finland
Scandinavia
Other Europe
North America
ROW
18 May 2017 Orion Capital Markets Day 2017 108
Sales in Finland continue to be important, but own sales network
covers today most of Europe
Orion’s sales network
![Page 109: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/109.jpg)
18 May 2017 Orion Capital Markets Day 2017 109
Steady sales growth for Specialty Products
0%
5%
10%
15%
20%
0
150
300
450
600
2012 2013 2014 2015 2016
EU
R m
illion
Net sales Growth, %
Sales in 2016
59% 16%
12%
13%
Finland
Scandinavia
Eastern Europe & Russia
ROW
71%
21%
8%
Gx OTC Biosimilars
![Page 110: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/110.jpg)
● Mainly Orion in-house developed prescription
drugs with valid product protection
● Global sales and R&D partner networks
Key drivers for business
Easyhaler, Dexdor, & Simdax
Possible milestones from development pipline
projects
New products from R&D pipeline
Generic competition for Stalevo and
Comtan/Comtess
0
50
100
150
200
250
300
350
400
450
20122013201420152016
EU
R m
illion
Net sales
Other
Simdax
Easyhaler
Dexdor
Precedex
Stalevo/Comtess/Comtan
18 May 2017 Orion Capital Markets Day 2017 110
Proprietary Products - portfolio is today more balanced
![Page 111: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/111.jpg)
18 May 2017 Orion Capital Markets Day 2017 111
SG&A expenses in good control
22%
23%
24%
25%
26%
27%
0
50
100
150
200
250
2011 2012 2013 2014 2015 2016
EU
R m
illion
SG&A expenses
Administration
Sales&marketing
SG&A as % of Net sales
22%
24%
26%
28%
30%
32%
34%
0
200
400
600
800
1,000
1,200
2011 2012 2013 2014 2015 2016
EU
R m
illion
Sales&marketing expenses
Net Sales outside Europe
Net Sales in Europe
S&M as % of sales in Europe
![Page 112: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/112.jpg)
EUR million 12/16 12/15 Change %
Non-current assets 372 373 -0.5%
Inventories 228 206 +11%
Trade receivables 200 192 +4%
Other receivables 32 31 +3%
Cash 232 245 -5%
Current assets total 691 674 +3%
Assets 1,063 1,047 +2%
EUR million 12/16 12/15 Change %
Equity total 641 595 +8%
Interest-bearing non-
current liabilities 150 178 -16%
Non-current liabilities 191 219 -13%
Trade payables 106 99 +7%
Current liabilities 231 233 -1%
Liabilities total 422 452 -7%
Equity and liabilities 1,063 1,047 +2%
18 May 2017 Orion Capital Markets Day 2017 112
Financial position
![Page 113: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/113.jpg)
0
10
20
30
40
50
60
70
80
2011 2012 2013 2014 2015 2016
EU
R m
illion
Orion Capex
Intangible assets
Property, plant andequipment
Depreciation,amortisation andimpairment
18 May 2017 Orion Capital Markets Day 2017 113
Good control of capital expenditure, but building for the future - Capex has exceeded depreciations
![Page 114: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/114.jpg)
18 May 2017 Orion Capital Markets Day 2017 114
Management of Net working capital
- Challenge: Change in business portfolio towards generics
-30%
-20%
-10%
0%
10%
20%
30%
2011 2012 2013 2014 2015 2016
ReceivablesInventoriesShort-term non-interest bearing liabilitiesNet Working Capital
-300
-200
-100
0
100
200
300
2011 2012 2013 2014 2015 2016
EUR million % of net sales
![Page 115: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/115.jpg)
18 May 2017 Orion Capital Markets Day 2017 115
Dividend distribution
1.3
0
1.3
0
1.2
5
1.3
0
1.3
0
1.5
5
0.12
70%
75%
80%
85%
90%
95%
100%
1.00 €
1.10 €
1.20 €
1.30 €
1.40 €
1.50 €
1.60 €
2011 2012 2013 2014 2015 2016*
Repayment of capitalper share
Dividend per share
Dividend payout ratio
*) Dividend includes extra
dividend of EUR 0.20
Orion’s dividend distribution takes into account distributable funds and capital expenditure and other
financial requirements in medium and long term to achieve the financial objectives.
Dividend distribution history
![Page 116: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/116.jpg)
18 May 2017 Orion Capital Markets Day 2017 116
Key ratios have been at very good level for years - Dividends and seasonality in profitability however have impact
30%
35%
40%
45%
50%
55%
60%
65%
70%
2011 2012 2013 2014 2015 2016
Equity ratio ROCE-% ROE-%
30%
35%
40%
45%
50%
55%
60%
65%
70%
2011 2012 2013 2014 2015 2016
At the end of Year At the end of Q1
![Page 117: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/117.jpg)
Key drivers for achieving financial targets
18 May 2017 Orion Capital Markets Day 2017 117
![Page 118: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/118.jpg)
18 May 2017 Orion Capital Markets Day 2017 118
Opportunities and challenges
Easyhaler
Dexdor
Simdax
R&D Pipeline
Proprietary Products
New product launches
Biosimilars
Specialty Products
R&D Pipeline
Animal Health
QuikRead
GenRead
Orion Diagnostica
Orion
Competition
Regulation
R&D risks
![Page 119: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/119.jpg)
18 May 2017 Orion Capital Markets Day 2017 119
Current products/markets drive Mid term development
- e.g. continued growth of Easyhalers & market position in Finland
102 105 122 157
299
0
50
100
150
200
250
300
350
EU
R m
illion
Largest pharmaceutical companies in Finland in 2016
02468
1012141618
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4
2013 2014 2015 2016
EU
R m
illion
Other Bufomix Easyhaler
Quaterly sales of Easyhalers
![Page 120: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/120.jpg)
18 May 2017 Orion Capital Markets Day 2017 120
Long term growth opportunities via R&D collaboration
Collaboration with partners
Target
identification
and validation
8–24 mo
Hit to Lead
generation
12–24 mo
Lead
optimisation
18–36 mo
Candidate
selection,
preclinical
development
12–24 mo
Phase I
12–14 mo
Phase II
12–36 mo
Phase III
18–48 mo
Late stage
development Early development Research
Collaboration with partners
![Page 121: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/121.jpg)
Project Indication PHASE Registration
Easyhaler® salmeterol-fluticasone Asthma, COPD Bioequivalence
study Registration
Darolutamide (ODM-201) 1) Prostate cancer (nmCRPC) I II III
Darolutamide (ODM-201) 1) Prostate cancer (mHSPC) I II III
Levosimendan 2) Low Cardiac Output Syndrome I II III
1) In collaboration with Bayer 2) Partner: Tenax Therapeutics, Inc. = Phase completed
= Phase ongoing
= Status changed
18 May 2017 Orion Capital Markets Day 2017 121
Mid term growth drivers from pipeline
More info about R&D projects at: http://www.orion.fi/en/rd/orion-rd/pipeline/
![Page 122: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/122.jpg)
Project Indication PHASE Registration
ODM-109 (oral levosimendan) ALS I II
ORM-12741 (alpha-2c adrenoceptor antagonist) 3) Alzheimer’s disease I IIa
ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II
ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II
ODM-207 (BET protein inhibitor) Cancer I
3) In collaboration with Janssen Pharmaceuticals = Phase completed
= Phase ongoing
18 May 2017 Orion Capital Markets Day 2017 122
Longer term pipeline opportunities
More info about R&D projects at: http://www.orion.fi/en/rd/orion-rd/pipeline/
![Page 123: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/123.jpg)
18 May 2017 Orion Capital Markets Day 2017 123
TOP Supply Chain Quality and Compliance
Robust compliance level with justified Orion approach
Culture: quality on the shop floor
Right first time execution
Eliminate redundant work
Zero work accidents
Service Level
Customer centric approach
From supply to demand driven
Optimise end to end processes
One joint Orion supply chain approach
Productivity
Lower costs to improve margins
Optimise procurement
Improve plant efficiency
Simplify operations
Increase organisational effectiveness
Optimise CAPEX
Vision 2018: The
most competitive,
demand-driven
supply chain.
Maximization of value
for the customer
through optimized
operational network.
![Page 124: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/124.jpg)
Continuous development of sales operations
• Competence development
• Active alignment of sales resources & processes and product portfolio
• Use of contract sales organizations
• Partnering
• Digitalization
Administration and support functions mostly centralized
• Information management, legal, etc. mostly in Finland
• Continuous process and system development
• Centralization allows use of scale and building of competencies
18 May 2017 Orion Capital Markets Day 2017 124
SG&A drivers
![Page 125: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/125.jpg)
Large product portfolio and supplier network has made and will make management of net working capital challenging
• Number of SKU’s has though been relatively stabile over last years due to active management
• Supplier relationship management
• Accounts payable amount has increased due to longer payment terms
Timing of capital expenditure has been actively managed
• To allow sufficient resources for good project execution
• To manage cash flow
• No new major individual investment needs in mid term, but on going updating of current facilities and capabilities continue
18 May 2017 Orion Capital Markets Day 2017 125
Capital expenditure & Net working capital
![Page 126: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/126.jpg)
31 Dec 2016 (EUR million)
Orion
Corporation
Orion
Group
Share capital 92.2 92.2
Reserves 1.4 4.6
Retained earnings
Orion Corporation 317.3 317.3
Subsidiaries 94.5
Consolidation and IFRS adjustments 140.9
Translation adjustments -8.1
Non-controlling interests 0.0
Total equity 410.9 641.4
18 May 2017 Orion Capital Markets Day 2017 126
Equity structure and Profit distribution
Of these 218
million was
distributed in
March 2017
left EUR
0.71/share
IFRS and
consolidation
items not
available for
profit
distribution
![Page 127: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/127.jpg)
18 May 2017 Orion Capital Markets Day 2017 127
Summary - Actions are driven by financial objectives
– Maximize value of
current products
– R&D pipeline
development
– Development of generic
portfolio
– Focused sales operations
– Compliance, Service
level and Cogs
– Sales growth
– Management of cost
structure
– Management of
complexity
– Product portfolio
– Resource management
– Good profitability
– Management of working
capital
– Optimization and timing
of capex
Increasing net sales EBIT > 25% of net sales Equity ratio ≥ 50%
At least 1.30/share and growing dividends
![Page 128: Orion Capital Markets Day 2017 · 7 18 May 2017 Orion Capital Markets Day 2017 Orion today – year 2016 in figures 32% 31% 16% 8% 13% Sales split by market area Finland Scandinavia](https://reader033.vdocuments.mx/reader033/viewer/2022053009/5f0c719c7e708231d4356dfd/html5/thumbnails/128.jpg)
Q&A
18 May 2017 Orion Capital Markets Day 2017 128