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Paths to reach Orion’sgrowth target 2025
Jari Karlson, CFO
Jefferies 2019 Healthcare Conference
New York, 5 June 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.
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 2
Disclaimer
37%
48%
8%5% 2%
Sales by business
Proprietary ProductsSpecialty ProductsAnimal HealthFermionContract manufacturing
3
Orion at a glance (2018 figures)
32%
16%31%
6%
15%
Sales by market area
FinlandScandinaviaOther EuropeNorth AmericaROW
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
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
Strategic growth target: Net sales EUR 1.5 billion in 2025
Financial objectives:
Growing net sales more rapidly than growth of the pharma market. Achievement of this objective requires continuous investment in development of the product portfolio.
≥ Keeping the equity ratio at least 50%.
> Maintaining profitability at a good level. The aim is operating profit that exceeds 25% of net sales. €
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.
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 4
Orion’s financial objectives remain the same –Strategic growth target just made more tangible
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 5
Today’s agenda – key elements of Orion’s growth
Proprietary Products and R&D
Specialty Products
Growth drivers
Generate cash flow to fund growth
investments
Support growth
Animal Health
Fermion
Defensiveindustry
Support growth
APIs for R&D and Proprietary
Products
Less vulnerable to
macroeconomic volatility
Grow Grow and defend Maintain and defend
Sales in 2018:mEUR 90 (+18%)
Sales in 2018:mEUR 59 (+4%)
Sales in 2018:mEUR 100 (-3%)
Sales in 2018:mEUR 63 (-2%)
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 6
Proprietary Products growth driven by Easyhaler in theshort term – mid and long term growth from pipeline
Late stage clinical development pipeline In-licensing
Darolutamide (nmCRPC) Filed, 1st approval late 2019e
Darolutamide (mHSPC)Ph III (completion 2022 H2e) Product acquisitions
ODM-109 (REFALS study)Ph III (completion 2020 H2e)
Easyhaler tiotropiumBioequivalence study Collaboration projects
Project Indication Phase Registration
Easyhaler® tiotropium COPD Bioequivalence study
Darolutamide 1) ARAMIS study Prostate cancer (nmCRPC) I II III FDA Priority Review
Darolutamide 1) ARASENS study Prostate cancer (mHSPC) I II III
ODM-109 (oral levosimendan) ALS I II III
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
ODM-209 (CYP11A1 inhibitor) Prostate cancer (CRPC), breast cancer
I
1) In collaboration with Bayer
= Completed
= Ongoing
Orion’s key clinical drug development programs
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 7
More information on R&D projects: www.orion.fi/en/rd/orion-rd/pipeline/
● A structurally unique androgen-receptor antagonist
● Ongoing trials: ARAMIS for nmCRPC and ARANSENS for mHSPC
● Bayer has global commercial rights.
● Orion to co-promote in 16 European countries.
● Orion will manufacture the product.
● Milestone payments upon first commercial sales:
– mEUR 45 in the US, mEUR 20 in the EU and mEUR8 in Japan
● Tiered royalties on product sales
– Approx. 20%, including production revenue.
– Global in-market peak sales potential ≥ EUR 1bn
● Potential one-off payments if certain sales targets are met.
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 8
Darolutamide: Invented at Orion, co-developed with Bayer
N N
NC
F3C
S
OO
HNF
Enzalutamide (MDV-3100)EnzalutamideN
N N
NC
F3C
S
OO
HNF
ARN-509Apalutamide
Cl
NC
NN N
H
O
N NH
OH
ODM-201 Darolutamide(development phase product)
About darolutamide Collaboration with Bayer
Key findings of ARAMIS phase III trial: Darolutamide shows substantial efficacy and favourable safety profile
HR = Hazard ratio; RR = Risk reduction1N Engl J Med; DOI: 10.1056/NEJMoa1815671
● 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 compared to placebo.
– Discontinuation rates weresimilar between darolutamide and placebo.
30Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
40.4
18.4
Darolutamide Placebo
Metastasis freesurvival1 (months)
40.3
25.4
Darolutamide Placebo
Time to pain progression1 (months)
HR=0.41 59% RR
HR=0.65 35% RR
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
REFALS phase III trial – oral levosimendan for ALS
450 patients
• Levosimendan 1-2mg/day(300 patients)
• Placebo (150 patients)
Primary endpoints
• 12 weeks: Slow vital capacity(Breathing capacity compared to normal subjects)
• 48 weeks: ALS functional rating scale (Overall assessment of ALS symptoms)
104 ALS centres in 14 countries
10
Objective
• Demonstrate benefit of oral levosimendan on respiratory and overall function in ALS
Levosimendan originally developed for the treatment of acute decompensated heart failure.
Orphan Drug Designation in the US and in the EU.
Phase III trial conducted by Orion
Specialty Products Business as Orion’s bedrock
Net sales by region 2019 MAT3
466 MEUR 58%
15%
14%
13%
Net sales by product 2019 MAT3
71%
24%
5%
Generic drugsSelf-care productsBiosimilars
FinlandScandinaviaEastern Europe and RussiaOther markets
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 11
466 MEUR
ORION’S STRENGHTS
Known and trusted local brand
In-depth Nordic market understanding
Broad portfolio with constant flow of new products
Competitive supply chain management
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 12
Specialty Products growth opportunities
Generic prescriptiondrugs
OTC and self-care drugs
Biosimilars
In-licensing & product acquisitionsNiche generics
Expand to new market areas
Build strong brands in selectedmarkets
Expand business by collaborationarrangements
Be the commercial partner of choiceespecially in the Nordic
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 13
Growth opportunities for Animal Health and Fermion
Animal Health Fermion
Maximise currentproprietaryportfolio
Utilise strong localpresence in theNordic and Eastern Europe
In-licensingStrong brandCollaboration arrangements
R&D Deliver late stage pipeline
• APIs for Orion’sproprietary products
• Utilise third party sales opportunities
• While Orion invests in growth, we will also highly value the ability to pay dividends.
• Orion’s financial objective is to distribute 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.
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
Orion creates shareholder value also through dividends
14
1.00
0.95
1.00
1.20
1.30
1.30
1.25
1.30
1.30
1.55
1.45
1.50
0.100.06
0.12
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
Dividend per share Repayment of capital per share
Last 5 years*
TSR for the last 5 years +70%
+50% stock price increase +19% dividend return
Average annual TSR is +11.1%
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
…with a healthy total return for shareholders
Last 10 years*
TSR for the last 10 years +365%
+214% stock price increase+151% dividend return
Average annual TSR is +16.6%
*)All TSR figures are calculated for Orion’s B stock to end of Q1/19 (31 March 2019)
15
• Maintain solid profitability and generate cash for growth investments
• Smart portfolio management• New market entries
• Darolutamide M0• Darolutamide M1• Easyhaler tiotropium• ODM-109• Animal Health projects
• Maximise current portfolio • Successful commercialization
of pipeline products• Utilise in-licensing
opportunities
Proprietary Products R&D
Specialty Products
Animal HealthFermion
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019 16
Key takeaways: Growth driven by R&D and Proprietary Products
Animal Health: • Maximise current portfolio• Successful commercialization of
pipeline products• Collaboration and in-licensing
opportunitiesFermion: APIs for proprietary products
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
17
=+
Jefferies 2019 Healthcare Conference, New York © Orion Corporation 5 June 2019
Thank you!