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OrionInvestor presentation
Updated on 15 March 2019
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.
Investor Presentation © Orion Corporation 2
Disclaimer
Content
Investor Presentation © Orion Corporation 3
1) Orion in brief
2) R&D
3) Highlights of 1−12/2018
4) Outlook and financials
5) Businesses
6) Sustainability
7) Financial calendar
Orion in brief
5
Key messages
1
2 4
Investor Presentation © Orion Corporation
1Orion develops, manufactures and markets human and animal pharmaceuticals, and APIs. Products marketed in >100 countries.
2Balanced business model: Both proprietary drugs and generics.
3Growth targetedthrough new in-house developeddrugs.
4Core therapyareas in R&D: oncology, CNS and respiratorydiseases(Easyhalerfamily).
5Strong position in the Nordic generics market.
6Strong
profitability,
stable dividends.
37%
48%
8%5% 2%
Sales by business
Proprietary Products
Specialty Products
Animal Health
Fermion
Contract manufacturing
6
Orion at a glance (2018 figures)
32%
16%
31%
6%
15%
Sales by market area
FinlandScandinaviaOther EuropeNorth AmericaROW
Investor Presentation © Orion Corporation
On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated.
Net sales
Operating profit
Personnel
R&D investments
6 production sites in Finland
Own sales unit
in 26 European countries
977 MEUR
253 MEUR
3,154
104 MEUR
Investor Presentation © Orion Corporation 7
Steady development despite patent expiries
-5%-3%-1%1%3%5%7%9%11%
0
200
400
600
800
1,000
Parkinson franchise + Precedex
Other products
Growth, %
25%26%27%28%29%30%31%32%33%
0
50
100
150
200
250
300
2011 2012 2013 2014 2015 2016 2017 2018
Operating profit
Operating profit margin
EUR million EUR million
Net sales Operating profit
On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was
completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated.
47%
37%
8%
5%3%
Sales by business 2011
Proprietary Products Specialty ProductsAnimal Health FermionContract manufacturing & other
37%
48%
8%
5% 2%
Sales by business 2018
Investor Presentation © Orion Corporation 8
Orion’s product mix has changed
0
150
300
450
600
750
900
1,050
1,200
Net sales, EUR million
9
Our businesses
1
2 4
Investor Presentation © Orion Corporation
3
4
5
6
Proprietary Products
In-house developed drugs and other drugs with valid productprotection
Specialty Products
Generic prescription drugs, OTC and non-medicinalproducts, biosimilars
Animal Health
Medicine and well-beingproducts for animals
Fermion
Active pharmaceuticalingredients (APIs)
Contract Manufacturing
Production for otherpharmaceutical companies
Investor Presentation © Orion Corporation 10
Orion’s strategy for 2019-2013
Growth
Sustainability
Mission to build well-being
Investor Presentation © Orion Corporation 11
Orion had ~73,000 shareholders on 31 December 2018
42%
32%
7%
8%
5% 5%
By number of sharesHouseholds (Finnishretail)
Non-Finnish holders andnominee-registered
Private corporations
Public sector
Non-profit institutions
Financial and insurancecorporations
Other
62%
7%
13%
6%
9%3%
By number of votes
Research and development
Investor Presentation © Orion Corporation 13
Focus areas of Orion’s R&D
• Central nervous system
• Oncology
• Respiratory
(Easyhaler product
family)
Proprietary products
• Orion utilises the R&D of
proprietary products to
develop new medicines
for animals.
Animal Health
• APIs to Orion’s
proprietary products
• Generic APIs
• Contract development
for pharmaceutical
companies
Fermion
Together we can achieve more in R&D
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
development12‒24 mo.
Phase I
12‒14 mo.
Phase II
12‒36 mo.
Phase III
18‒48 mo.
Late stage
developmentEarly developmentResearch
Collaboration with partners
Investor Presentation © Orion Corporation 14
Project Indication Phase Registration
Easyhaler® tiotropium COPD Bioequivalence study
Darolutamide 1) Prostate cancer (nmCRPC) I II III
Darolutamide 1) Prostate cancer (mHSPC) I II III
ODM-109 (oral levosimendan) ALS I II III
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
ODM-208 (CYP11A1 inhibitor) Prostate cancer (CRPC) I
= Completed
= Ongoing
= Status changed
Orion's key clinical drug development projects
15
1) In collaboration with Bayer
More information on R&D projects:
https://www.orion.fi/en/rd/orion-rd/pipeline/
Investor Presentation © Orion Corporation
ARAMIS trial: Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer
Orion and Bayer’s phase III trial
of darolutamide for
non-metastatic castration-
resistant prostate cancer
● Detailed data presented at
the ASCO GU on 14 February 2019
and simultaneously published in the
New England Journal of Medicine.
● Darolutamide significantly extended
metastasis-free survival with a
favourable safety profile compared
to placebo.
● The application for marketing
authorisation has been submitted in
U.S., Japan and EU.
17
● Bayer is also having discussions with
other health authorities regarding the
submission for marketing authorisation
application.
● Darolutamide has been granted Fast
Track designation by the U.S. Food and
Drug Administration (FDA). If the
process proceeds as planned, the sales
could in the best-case scenario start in
the US already at the end of 2019.
● Phase III ARASENS trial for metastatic
prostate cancer continues.
Investor Presentation © Orion Corporation
Financial impacts of
darolutamide
● Bayer has the right to commercialize
darolutamide globally.
● Orion has the option of co-promoting in Europe.
Orion will manufacture the product.
● Milestone payments upon first commercial sales:
• EUR 45 million in the US
• EUR 20 million in the EU
• EUR 8 million in Japan
● Tiered royalties on product sales
− Approx. 20%, including production revenue.
● Potential one-off payments
if certain sales targets are met.
18Investor Presentation © Orion Corporation
Non-metastatic
castration-resistant
prostate cancer (nmCRPC)
● A form of prostate cancer associated with
rising PSA (Prostate-Specific Antigen) levels
despite androgen deprivation therapy (ADT).
● The cancer has not yet spread
beyond the prostate region.
● High risk for progression to metastatic disease.
● Until recently, there have been no effective
treatment options for this stage. The goal is to
achieve disease control without impacting
patients’ daily lives.
19Investor Presentation © Orion Corporation
Until recently, there have been no effective treatment
options for CRPC patients who have rising Prostate-Specific
Antigen (PSA) levels while on ADT and no detectable
metastases
Non-metastatic CRPC
20
● Darolutamide is a non-steroidal
androgen receptor antagonist that
binds to the receptor with high
affinity and inhibits the growth of
prostate cancer cells.
● In preclinical studies, darolutamide
has demonstrated low blood-brain
barrier penetration.
● This may explain the overall low
incidence of central nervous
system related adverse events.
Darolutamide has demonstrated
low blood-brain barrier penetration
that may lead to lower incidence of adverse events
Investor Presentation © Orion Corporation 9
Primary endpoint
● Metastasis-free survival (MFS)
Secondary endpoints
● Overall survival (OS)
● Time to pain progression
● Time to initiation of first cytotoxic chemotherapy
● Time to first symptomatic skeletal event
● Safety and tolerability
1,200 mg darolutamide + ADT
(600 mg twice a day)
− 955 patients
Placebo twice a day + ADT
− 554 patients
Random
izati
on
2:1
1,509 patients
Men with nmCRPC currently
being treated with ADT, and
at high risk for developing
metastatic disease
ARAMIS Phase III trial design
11
Summary of results:
Darolutamide shows substantial
efficacy and favourable
safety profile
● Darolutamide significantly improves metastasis-free survival (MFS):
– Median 40.4 months with darolutamidevs 18.4 months with placebo
– Overall improvement of 22 months
● Positive trend in overall survival (OS):
– 29% reduction in risk of death at interim analysis (P=0.045).
● Darolutamide has a favorablesafety profile:
– It didn’t increase rates of critical adverse events (seizures, falls, fractures, rash, cognitive disorder, mental impairment, hypertension) compared to placebo.
– Only fatigue occured in >10% of patients.
– Discontinuation rates similar betweendarolutamide and placebo.
● Significant benefit over placebo for time to pain progression:
– 40.3 months vs. with placebo 25.4 months
13Investor Presentation © Orion Corporation
24
ARASENS trial continues in order
to expand the indication to
metastatic prostate cancer
Patients
● Men with metastatic, hormone-sensitiveprostate cancer
Treatment
● Darolutamide plus androgen deprivation therapyand six cycles of docetaxel (chemotherapy)
Endpoints
● Primary:
Darolutamide over placebo in overall survival
● Secondary:
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
Status
● Recruitment finalized, estimated completion of the trial in 2022.
Investor Presentation © Orion Corporation
25
Global prostate cancer estimates (2018)
1
2 4
Investor Presentation © Orion Corporation
1.2
3 5
6million mendiagnosed withprostate cancer
358,000died fromthe disease
5thleading cause of death from cancer in men
50+Mainly affects men over 50, the risk increases with age
2ndmost commonly diagnosed malignancy in men worldwide
70
50 60 70 80
50 60 70 80
ODM-109: Oral levosimendan
for ALS
● First patients recruited in July
for the Phase III clinical trial (REFALS).
● By enhancing respiratory muscle function
in ALS patients, orally administered
levosimendan can help maintain breathing
capacity and benefit overall functioning
of ALS patients.
● Orion is investing approximately EUR 60 million
over three years in the trial.
● The aim is to apply for marketing authorisation
in the US and Europe.
● Levosimendan has been granted an Orphan Drug
Designation in the US and in the EU.
● It is a molecule originally developed by Orion for
the treatment of acute decompensated heart
failure. Simdax has been in the market for this
indication since 2000.
26Investor Presentation © Orion Corporation
ODM-109 (ALS):
REFALS phase III trial
27Investor Presentation © Orion Corporation
450 patients
• Levosimendan
1-2mg/day
(300 patients)
• Placebo
(150 patients)
Approx.100 clinical sites
• US, Canada,
Europe,
Australia
Primary endpoints
• 12 weeks:
Slow vital capacity
(Breathing
capacity compared
to normal subjects)
• 48 weeks:
ALS functional rating
scale (Overall
assessment of
ALS symptoms)
www.clinicaltrials.gov: NCT03505021
ALS (Amyotrophic lateral sclerosis)
as a rare disease
28
1−2∕
100,000Incidence
~16,800
Patients
in the US in 2017
~12,500
Patients
in Europe
~450−500
Patients
in Finland
Investor Presentation © Orion Corporation
29
ODM-208: Pan-steroid hormone synthesis inhibitor
(CYP11A1 inhibitor) for castration-resistant prostate cancer
ODM-208
with
androgen
deprivation
therapy
Steroids from
adrenal, testes
and tumor
Steroid producton
switched off
● Steroid hormones stimulate the growth of
hormonally regulated cancers, such as most
prostate and breast cancers.
● Hormonal treatments are highly effective, but
drug resistance will often eventually emerge
and cancer will start growing again.
● Preclinical studies have shown that ODM-208
inhibits the synthesis of steroids hormones. It
has potential efficacy also for those cancers
that have become resistant to the standard
hormonal treatments.
● The steroid hormones that are needed and do
not promote cancer growth are replaced with
additional medication.
Investor Presentation © Orion Corporation
Highlights in January–December 2018
31
Important year for future growth
1
Prostate cancer drug darolutamide met primary endpoint in October. Full data presented at ASCO GU on 14 February 2019.
2The net sales of Proprietary Products increased slightly particularly due to strong Easyhaler sales. Sales of Dexdor and Simdax remained at a good level. Sales of Parkinson’s drugs declined as anticipated.
2Profitability was good, profit margin for continuing operations exceeded financial target. Cash flow was strong. Net sales and operating profit were lower than in the comparative period. R&D investments increased.
Investor Presentation © Orion Corporation
3
5Strategic target in 2019–2023: Growing more rapidly than the growth in the market.
4Net sales of Specialty Products declined due to continued intense price competition in generic drugs in Finland and anticipated lower sales of biosimilars.
Dividend proposal: EUR 1.50 share.6
32
Key strategic target in 2019−2023:
Growing more rapidly than the growth in the market
1
2 4
1.5
Net sales target in 2025
Capital gain from the sale of Orion Diagnostica, EUR 128 million, supports growth opportunities.
Own investments in new clinical trials:
E.g. EUR 60 million investment in Phase III trial on ALS (REFALS).
In-licensing and product acquisitions:
E.g. reacquisition of Stalevo sales rights in Europe.
Investments in sales and marketing:
E.g. strengthening the Easyhalerproduct familysales force in Germany.
Investor Presentation © Orion Corporation
billion EUR
Investments supporting growth estimated at EUR 30 million in 2019.
33
Key figures 1−12/2018 (continuing operations)
253
Operating profit
MEUR (284)
-11%
2.32
Cash flow per share before financial
items**
EUR (1.09)
+112%
977
Net sales
MEUR (1,034)
-5%
Investor Presentation © Orion Corporation
26%
Operating profit margin
(27%)
**) Cash flow per share before financial items: Continuing and discontinued operations
Without the negative impact of exchange rate changes and
lower milestone payments and royalties, profitability
would have slightly improved from 2017
31
16
1219 23
54 6037 37 33
1019 13
22
1 5
284
253
1,034
977
Net sales, EUR million Operating profit, EUR million
Investor Presentation © Orion Corporation
(1) Biosimilars in local currency without exchange rate effect
(1) Product sales without sales margin and product mix change and exchange rate effect
(2) Product sales margin and product mix change without exchange rate effect
(3) Exchange rate effect on gross margin
34
Geographical breakdown and development of net sales
1−12/2018
32%
16%
31%
6%
15%
Finland
Scandinavia
Other Europe
North America
Other markets
0
50
100
150
200
250
300
350
1−12/2017 1−12/2018
Finland Scandinavia Other
EuropeNorth
AmericaOther
markets
35
EUR million
Investor Presentation © Orion Corporation
+5%
-11%
-2%
-26%
-5%
Net sales by business division
37%
48%
8%
5% 2%
Proprietary Products
Specialty Products
Animal Health
Fermion
Contract manufacturing & other
519
351
7651 36
473
357
8051
16
0
100
200
300
400
500
600
1−12/2017 1−12/2018
Specialty
Products
Proprietary
Products
Animal
Health
Fermion Contract
manufacturing
& other
EUR million
36
1−12/2018
Investor Presentation © Orion Corporation
-9%
+2%
+6%-1% -55%
. Indication
Net sales
(EUR million)
Change vs
1−12/2017
1. Parkinson’s disease 100 -3%
2. Asthma, COPD 90 +18%
3. Intensive care sedative 63 -2%
4. Acute heart failure 59 +4%
5. Animal sedatives 34 +10%
6. Intensive care sedative 26 +3%
7. BiosimilarsRheumatoid arthritis, inflammatory
bowel diseases, lymphoma25 -56%
8. Inflammatory pain 23 0%
9. Divina series Menopausal symptoms 19 +1%
10. Anticoagulant 18 -7%
Best-selling pharmaceuticals 1−12/2018
= Products of Proprietary Products business division
Investor Presentation © Orion Corporation 37
Proprietary Products
Proprietary Products
Easyhaler● Strong growth, investments in
sales and marketing particularly in Germany.
● Salmeterol-fluticasone Easyhaler sales started.
Investor Presentation © Orion Corporation 39
Dexdor● Dexdor sales continued to
grow in most of the countries. In 2018 there was significant generic competition only in Germany, but competition is expected to expand in 2019.
Simdax
● Sales increased slightly. Possible generic competition is not estimated to have a material impact on sales in 2019.
Parkinson’s drugs
● Sales were lower than in comparative period, as anticipated. However, the decline in sales was significantly slower than in the long term on average.
Sales of Proprietary Products increased slightly
104
77
6457
25
100
90
6359
26
0
20
40
60
80
100
120
1−12/2017 1−12/2018
Parkinson’s
drugs
Easyhaler
product
family
Dexdor Simdax Precedex
EUR
million
Investor Presentation © Orion Corporation 40
1−12/2018
Parkinson: Stalevo, Comtess & Comtan
Easyhaler
Dexdor
Simdax
Precedex
Others
28%
5%
17%
7%
25%18%
-3%
+18%
-2%+4%
+3%
05
101520253035404550
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4
2014 2015 2016 2017 2018
Deliveries of Parkinson’s drugs (Stalevo, Comtess/Comtan) to key partners
Orion’s own sales
Decrease in sales of Parkinson’s drugs slowed down
Source: IQVIA, MAT9/2018
Sales, EUR millionSales of Orion’s branded
Parkinson’s drugs by market area
2%
Europe
Japan
ROW
USA
35%
33%
30%
Investor Presentation © Orion Corporation 41
Repatriation of Stalevo's sales and distribution
rights in Europe reinforces Orion's growth targets
● The rights were transferred
back from Novartis in
December:
– 18 EU countries and a few
other European country.
● Added sales initially
around EUR 20 million/year.
● Provides Orion with greater
opportunities to promote
Stalevo sales and to extend the
product's life cycle.
● Orion paid USD 24.5 million for
the transfer of sales rights, to
be depreciated over two years.
42Investor Presentation © Orion Corporation
43
Easyhaler product family will be a key
source of growth in the next few years
0
5
10
15
20
25
30
Q1Q2Q2Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4
2014 2015 2016 2017 2018
Sales, EUR million
Budesonide-formoterol Easyhaler Others
● Continued strong growth for budesonide-formoterol Easyhaler.
● Product family total sales:
● Budesonide-formoterol Easyhaler:
– Strong market position in some markets, e.g. in Sweden (40%).*
– Growth still attainable in certain markets. Investments in sales and marketing made particularly in Germany (market share 7%).
● Salmeterol-fluticasone sales started in the first European countries in late 2018.
● Development of seventh product, tiotropium, continues.
+18%
+29%
Investor Presentation © Orion Corporation*) Market shares of volumes in November 2018
0
2
4
6
8
10
12
14
16
18
20
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2014 2015 2016 2017 2018
Sales, EUR million
Sales of Dexdor intensive care sedative continued to grow
in most European markets – generic competition expected
to expand in 2019
65%
11%
12%
12%
Total value of the European sedatives
market: EUR 558 million (+3%)
Propofol EUR 361 million (+4%)
Midazolam EUR 62 million (-4%)
Dexmedetomidine EUR 69 million (+12%)
Remifentanil EUR 66 million (–2%)
Investor Presentation © Orion Corporation 44
Source: IQVIA, MAT 9/2018
Specialty Products
Specialty Products
Investor Presentation © Orion Corporation 46
● Net sales decreased in Finland and Scandinavia, and grew in Eastern Europe and Russia.
● Net sales of biosimilars decreased from record year 2017.
● The decrease was due to tightened competition, declined price level and the situation of tendering competitions.
● Orion won the national tender in Norway in late 2018, deliveries to start in Q1/2019.
● In Finland, sales of Amgevita (adalimumab), Orion’s first biosimilar for outpatient use, started at the end of the year.
• In Finland, price competition has led to a decline in the entire market of reference priced prescription drugs. Impact on Orion’s sales was EUR 15 million negative in 2018.
• Prices are expected to continue decline in 2019, but impact on sales is anticipated to be slightly lower than in 2018.
Specialty Products: tightened price competition and lower
sales of biosimilars showed as a decrease in net sales
Investor Presentation © Orion Corporation 47
Net sales by region1−12/2018
58%
15%
14%
13%
Net sales by product1−12/2018
71%24%
5%
Generic drugs
Self-care productsBiosimilars
292
9465
273
69 66
0
50
100
150
200
250
300
350
EUR
million
Finland Scandinavia Eastern
Europe and
Russia1−12/2017 1−12/2018
Finland
Scandinavia
Eastern Europe and Russia
Development of net sales
-26%+2%
-7%
Other markets
The sales of Orion’s reference priced prescription drugs in Finland
-7%Market development Orion’s development
-9%
490
The market of reference priced prescription drugs in Finland (1–12/2018)
MEUR (528)
In Finland, price competition has led to a decline in the
entire market of reference priced prescription drugs
Source: IQVIA pharmaceutical sales statistics 1–12/2018.
Reference priced prescription drugs in the pharmacy channel.Investor Presentation © Orion Corporation 48
126MEUR (139)
105 120 123 124
187
126
96
0
50
100
150
200
250
300
350
GSK Roche Pfizer Sanofi MSD Orion
Human pharma market in Finland (1−12/2018)Medicinal and non-medicinal products
in hospital and pharmacy channels: EUR 2,746 million
EUR million
Orion is Finland's most significant
provider of pharmaceuticals
11%Investor Presentation © Orion Corporation 49
314
Source: IQVIA pharmaceutical sales statistics 1–12/2018
(13%)Reference priced prescription drugs (pharmacy channel)
Self-care products (pharmacy channel) 11%
Human pharmaceuticals total
25%
Self-care products
ReferencepricedprescriptiondrugsOrion market share
in pharmacy
26%(26%)
Orion market share
in pharmacy
(13%)
(26%)
Orion market share
in pharmacy & hospital
Orion's key business targets in 2019
1. Preparation for the commercialisation of
darolutamide. ARASENS trial (metastatic
prostate cancer) continues in order to
expand the indication.
2. Phase III clinical trial (REFALS) for orally
administered levosimendan (ODM-109) in
ALS and preparation for possible
commercialisation.
3. Strengthening Orion’s position as Finland's
most significant provider of generic drugs;
competitive pricing.
4. Competitive product portfolio in Specialty
Products and strengthening of product
launches.
Investor Presentation © Orion Corporation
5. Accelerating the growth of
the Easyhaler product family and
strengthening its market position.
Salmeterol-fluticasone launch
progressing in Europe.
6. Evaluation of new in-licensing
opportunities in Europe, particularly
in the area of hospital care.
50
Digital projects
to improve
patients' well-being
Investor Presentation ©Orion Corporation
● ToxBuddy:
Information and
support for veterinary
practitioners in the
treatment of poisoning
in dogs.
51
● Orion and
Fifth Corner Inc:
The research project
aims to help prostate
cancer patients manage
the stress caused by
their disease.
● Daisy:
Optimising Parkinson’s
patient’s quality ON-time
(the period when
medication is effective,
and symptoms are under
control) by gathering data
on the patient’s condition.
● Connected
Easyhaler:
Improving the user
experience of
Easyhaler products.
Outlook
Investor Presentation © Orion Corporation 53
Investments in growth
EUR 30 million in 2019
● This comprises clearly
increased depreciation as
well as investments in
sales and marketing and
research.
● At the same time, operating
profit is burdened by
intense price competition in
the market and gradually
expanding generic
competition for Orion’s old
proprietary drugs.
● The ongoing projects
supporting growth are
expected to burden Orion’s
profit in 2019 by an
estimated EUR 30 million.
Net salesOrion estimates that in 2019 net sales will be
slightly higher than in 2018
(net sales in 2018 were EUR 977 million).
The estimated net sales include the possible EUR 45 million
milestone payment associated with the commercialisation of
darolutamide.
Operating
profit Operating profit is estimated to be at the same level
as in 2018 (operating profit in 2018 was EUR 253 million).
The estimated operating profit includes the possible
EUR 45 million milestone payment associated with
the commercialisation of darolutamide as well as
significant investments in actions to generate growth.
Outlook for 2019
Investor Presentation © Orion Corporation 54
=
+
55 42
The profit impact of the sale of Orion Diagnostica
closed on 30 April 2018
+128Capital gain
MEUR
+5Pension gain
MEUR
-1
Administrative costsof the transaction
MEUR
MEUR
Investor Presentation © Orion Corporation
Financials
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.
57
Orion’s financial objectives
Investor Presentation © Orion Corporation
-6%
-4%
-2%
0%
2%
4%
6%
8%
0
200
400
600
800
1,000
1,2002012
2013
2014
2015
2016
2017
2018
Net sales
Net sales, EURmillion
1.15
1.20
1.25
1.301.35
1.40
1.45
1.501.55
1.60
2012
2013
2014
2015
2016*
2017
2018**
Dividend
Dividend per share, EUR
Target
58
Financial objectives
0%3%6%9%12%15%18%21%24%27%30%
0255075
100125150175200225250275300
2012
2013
2014
2015
2016
2017
2018
Operating profit
Operating profit, EUR millionOperating profit marginTarget
*) 2016: includes extra dividend EUR 0.20
**) 2018: Board proposal
Investor Presentation © Orion Corporation
On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was
completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated.
59
Key figures by quarter
74 67 83 80 88 70
61 86 74 84 71 70
67 64 59 92 55 45
66 55 5159
7169
0
100
200
300
400
13 14 15 16 17 18
Operating profit, EUR million
Q4
Q3
Q2
Q1
249 245 260 262 266 247
248 277 255 273 261 246
237 238 239 259 242 222
273 255 262 280 266 262
0
500
1,000
1,500
13 14 15 16 17 18
Net sales, EUR million
Q4
Q3
Q2
Q1
0.39 0.37 0.47 0.45 0.48 0.38
0.33 0.48 0.41 0.47 0.39 0.40
0.350.35 0.32
0.520.31
0.24
0.40 0.29 0.28
0.340.38
0.38
0.00
0.50
1.00
1.50
2.00
13 14 15 16 17 18
Basic earnings per share, EUR
Q4
Q3
Q2
Q1
0.070.30 0.38 0.29 0.33 0.390.19
0.62 0.29 0.27 0.07 1.360.29
0.410.44 0.67 0.47
0.36
0.46
0.380.40 0.39
0.22
0.22
0.00
0.50
1.00
1.50
2.00
2.50
13 14 15 16 17 18
Q4
Q3
Q2
Q1
Cash flow per share
Before financial items, EUR
Investor Presentation © Orion Corporation
Net sales, EUR million Operating profit, EUR million
Basic earnings per share, EURCash flow per share
before financial items*, EUR
On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was
completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated.
*) continued and discontinued operations
Key figures
60
Orion’s key figures 2013 2014 2015 2016 2017 2018
Change
vs. 2017
Net sales, EUR million 1,006.9 1,015.3 1,015.6 1,073.5 1,033.6 977.5 -5.4%
Operating profit, EUR million 267.7 272.4 266.6 314.6 284.1 252.8 -11.0%
Profit before taxes, EUR million 264.0 267.8 262.3 310.9 277.7 248.4 -10.6%
R&D expenses, EUR million 101.9 106.2 108.1 118.2 99.1 104.0 +4.9%
Equity ratio, % 53.6% 52.3% 57.4% 60.8% 64.6% 68.8%
Gearing, % 8.4% -4.7% -9.6% -12.4% -1.9% -17.1%
ROCE (before taxes), % 38.5% 36.6% 35.7% 40.9% 36.2% 44.3%
Return on equity, % 40.3% 41.1% 37.5% 40.3% 34.2% 45.5%
Basic earnings per share, EUR 1.46 1.50 1.48 1.77 1.56 1.40 -10.3%
Cash flow per share before financial
items, EUR 1.02 1.72 1.51 1.62 1.09 2.32 +112.4%
Dividend per share, EUR 1.25 1.30 1.30 1.55* 1.45 1.50 +3.4%
*) 2016: dividend includes extra dividend of EUR 0.20
Investor Presentation © Orion Corporation
The figures in the table include both continuing and discontinued operations.
Income statement
61
Formation of profits, EUR million 2013 2014 2015 2016 ADJ.2017 2018
Change vs.
2017
Net sales 1,006.9 1,015.3 1,015.6 1,073.5 1,033.6 977.5 -5.4%
Cost of goods sold -393.5 -401.7 -405.8 -421.7 -417.6 -387.9 -7.1%
Gross profit 613.4 613.6 609.8 651.8 616.0 589.6 -4.3%
Other operating income and
expenses 5.6 1.7 1.5 24.3 4.9 5.5 +10.8%
Sales and marketing expenses -204.9 -193.4 -190.4 -194.7 -188.9 -195.3 +3.4%
R&D expenses -101.9 -106.2 -108.1 -118.2 -99.1 104.0 +4.9%
Administrative expenses -44.5 -43.3 -46.2 -48.7 -48.8 -43.0 -11.8%
Operating profit 267.7 272.4 266.6 314.6 284.1 252.8 -11.0%
Profit before taxes 264.0 267.8 262.3 310.9 277.7 248.4 -10.6%
Profit for the period for continuing
operations 219.1 197.3 -9.9%
Profit for the period for
discontinued operations 7.0 132.9
Profit for the period 206.2 211.3 208.2 249.0 226.0 330.3 +46.2%
Investor Presentation © Orion Corporation
The figures in the table include both continuing and discontinued operations.
EUR million 12/18 12/17
Change
%
Non-current assets total 418.5 434.7 -3.7%
Inventories 222.1 225.4 -1.5%
Trade receivables 188.8 199.0 -5.1%
Other receivables 33.7 32.4 +4.0%
Cash & cash equivalents &
money market investments 283.7 164.1 +72.9%
Current assets total 728.2 620.8 +17.3%
Assets total 1,146.7 1,055.5 +8.6%
Financial position
62
EUR million 12/18 12/17
Change
%
Equity total 773.1 679.7 +13.7%
Interest-bearing non-current
liabilities 0.6 150.3 -99.6%
Non-current liabilities total 59.8 196.2 -69.5%
Current liabilities total 313.8 179.7 +74.7%
Liabilities total 373.6 375.8 -0.6%
Equity and liabilities total 1,146.7 1,055.5 +8.6%
Investor Presentation © Orion Corporation
The consolidated statement of financial position includes both continuing and discontinued operations.
0
10
20
30
40
50
60
70
80
90
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Orion Capex, EUR million
Property, plant and equipment
Intangible assets
Depreciation, amortisation andimpairment
Development of capital expenditure
63Investor Presentation © Orion Corporation
-30%
-20%
-10%
0%
10%
20%
30%
40%
2012 2013 2014 2015 2016 2017 2018
ReceivablesInventoriesShort-term non-interest bearing liabilitiesNet Working Capital
Development of net working capital
64
-300
-200
-100
0
100
200
300
400
2012 2013 2014 2015 2016 2017 2018
Receivables
Inventories
Short-term non-interest bearing liabilities
Net Working Capital
EUR million% of net sales
Investor Presentation © Orion Corporation
Dividend distribution policy
65
1.0
0
0.9
5
1.0
0
1.2
0
1.3
0
1.3
0
1.2
5
1.3
0
1.3
0
1.5
5
1.4
5
1.5
0
0.10
0.06 0.12
60%
65%
70%
75%
80%
85%
90%
95%
100%
0.00
0.25
0.50
0.75
1.00
1.25
1.50
1.75
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Repayment of capital per share
Dividend per share
Dividend payout ratio
2016: includes extra dividend EUR 0.20
2018: Board proposal
• 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 historyEUR
Investor Presentation © Orion Corporation
Orion B share performance January 2016 – December 2018
Investor Presentation © Orion Corporation 66
60
70
80
90
100
110
120
130
140
150
160
170
180
190
200
31/12/15
29/2/16
30/4/16
30/6/16
31/8/16
31/10/16
31/12/16
28/2/17
30/4/17
30/6/17
31/8/17
31/10/17
31/12/17
28/2/18
30/4/18
30/6/18
31/8/18
31/10/18
31/12/18
Index 31/12/2015=100
Orion B 94.71
Orion B total return 104.10
Europe/Pharmaceutical 86.94
OMXH-Portfolio 107.2
Business units
68
Proprietary Products: In-house developed prescription
drugs with valid product protection
0
50
100
150
200
250
300
350
400
2012 2013 2014 2015 2016 2017 2018
Net sales
Other
Simdax
Easyhaler
Dexdor
Precedex
Stalevo/Comtess/Comtan
EUR million
Investor Presentation © Orion Corporation
Easyhaler, Simdax
Possible milestones
New products from R&D pipeline
Generic competition
Global sales andR&D partner networks
Key drivers:
69
Year Indication
Salmeterol-
fluticasone Easyhaler®
Budesonide-
formoterol Easyhaler®
2018
2014
Asthma and COPDFormoterol Easyhaler® 2004
Budesonid Easyhaler® 2002
Beclomet Easyhaler® 1994
Buventol Easyhaler® 1993
Product Indication Year
Sedative for ICU use 2011
Parkinson’s disease 2003
Acute decompensated
heart failure2000
Sedative for ICU use 1999
Parkinson’s disease1998
Breast cancer 1988
Proprietary human pharmaceuticals developed by Orion
Investor Presentation © Orion Corporation
Diverse treatment options for
asthma and COPD by utilizing
the same inhaler technology
70
● Easyhaler is a dry-powder inhaler developed in-house
● Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances:
– salbutamol, beclometasone, budesonide, formoterol, salmeterol and fluticasone
● Key benefits:
– Dosing accuracy and consistent deposition
– Easy to teach, learn and use
– A wide range of products
Investor Presentation © Orion Corporation
Investor Presentation © Orion Corporation
Easyhaler product family is expanding
2018Tiotropium
development
started
71
72
Specialty Products: Generic prescription drugs, biosimilars and OTC
including also non-medicinal products
-10%-8%-6%-4%-2%0%2%4%6%8%10%12%14%16%18%20%22%
0
50
100
150
200
250
300
350
400
450
500
550
Net sales Growth, %
EUR million
Investor Presentation © Orion Corporation
Portfolio of
hundreds
of products
73
Animal Health
-4%
-2%
0%
2%
4%
6%
8%
10%
12%
0
15
30
45
60
75
90
105
2012 2013 2014 2015 2016 2017 2018
Net sales Growth, %
EUR million
Investor Presentation © Orion Corporation
In-licensed products sold in own sales areas
Medicinal and non-medicinal products for companion animals and livestock
In-house developed proprietary products sold globally through own sales network and through partners
74
Fermion has an important strategic role
-20%
-10%
0%
10%
20%
30%
40%
50%
0
10
20
30
40
50
60
70
2010
2011
2012
2013
2014
2015
2016
2017
2018
Net sales* Growth, %
*) Excluding supply to Orion
EUR million
Investor Presentation © Orion Corporation
Active pharmaceutical ingredients (APIs) for Orion’s own Proprietary Products
Generic APIs for Orion and other pharma companies
Contract development and manufacturing of APIs
EUR >30
million
● Special expertise in demanding production
of active pharmaceutical ingredients (APIs),
e.g. extremely potent substances.
● The aim is to captively manufacture
the APIs for Orion's in-house developed
proprietary drugs, such as darolutamide.
● Modernised, advanced technology at Hanko
strengthens Fermion's global competitive
position, meets increasingly strict regulatory
requirements and provides the means to
meet growing demand.
● The Hanko facility manufactures
azathioprine and entacapone, among
others, in which Fermion is the leading
manufacturer globally.
6,000
m2
Fermion's new production plant operational in Hanko
– nearly 100% of production is exported
Expansion
investment
2016−2018
Production facility
and equipment
for the production
of APIs
200->
300 t
Enables
capacity
increase
~20
Number of APIs
manufactured
at Hanko
75Investor Presentation © Orion Corporation
76
Contract manufacturing & other
-70%
-55%
-40%
-25%
-10%
5%
20%
35%
50%
0
10
20
30
40
2012 2013 2014 2015 2016 2017 2018
Net sales Growth, %
EUR million
Investor Presentation © Orion Corporation
Pharmaceutical manufacturing for other companies
Sustainability is built into Orion’s mission
7878
Material themes of Orion’s sustainability
LTIF 1 (6.3)
5.5
Injury rate
1,074
Energysavings
MWh (3,725)
238
Audits undertakenby Orion
(314)
40%
Energy savings target set for 2025
achieved
(31%)
56
Customer complaints
(Pharmaceuticals)
Ppm (64)
• Patient safety
• Ensuring reliable supply of medications
• Manufacturing medications in an
environmentally sustainable way:
efficient use of materials, energy
efficiency, wastewater management
Investor Presentation © Orion Corporation
We assess product safety throughout the lifecycle
79Investor Presentation © Orion Corporation
Orion calendar
Annual General Meeting 26/3/2019
Interim Report 1−3/2019 25/4/2019
Half-Year Financial Report 1−6/2019 17/7/2019
Interim Report 1−9/2019 23/10/2019
Capital Markets Day
in Helsinki on 22/5/2019
Investor Relations
Heidi Ahti
Executive Assistant
(Investor meeting requests)
+358 10 426 2169
Jari Karlson
CFO
+358 10 426 2883
Lilli Riikonen
Communications Manager
+358 10 426 2319
www.orion.fi/EN/Investors
twitter.com/OrionCorpIR
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