Jaarlijkse Algemene Vergadering van Aandeelhouders Waregem, … Fagron 11 m… · Global market...
Transcript of Jaarlijkse Algemene Vergadering van Aandeelhouders Waregem, … Fagron 11 m… · Global market...
Jaarlijkse Algemene Vergadering van Aandeelhouders
Waregem, 11 mei 2015, 15:00 uur
De Voorzitter duidt Jan Peeters aan als
secretaris voor de AVA.
De Voorzitter stelt voor om Hans Stols aan te
duiden als stemopnemer.
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Verzoek om de agendapunten 1 tot en met 5
gezamenlijk te behandelen in een presentatie.
Verzoek tot ontheffing van de commissaris tot het
voorlezen van zijn rapport.
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Fagron
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Global presence
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Global presence
USA
Europe
South Africa
Colombia
Brazil
China
Fagron Group
7 sites – GMP, FDA
9 sites – GMP, FDA, ISO9001
3 sites
4 sites
4 sites – GMP, FDA, ISO9001
Purchase & quality office
28 sites
5,000 pharmaceutical raw materials
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Fagron
Founded in 1990 by current CEO Ger van Jeveren
This year celebration of 25 years dedication to compounding
Global market leader in pharmaceutical compounding
2,239 employees, incl. >300 pharmacists, in 30 countries
10% of annual turnover comes from innovations that were introduced in
the past two years
2014: turnover of € 447.1 million and REBITDA margin of 26.5%
Listed on Euronext Brussels and Amsterdam since 2007
Market capitalisation of € 1.1 billion
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Business model
FCS
Fagron Trademarks
Fagron Compounding Essentials
Raw materials
Excipients
Equipment
Supplies
Nuclear, Sterile, Aseptic and
Non-Sterile compounding
Fagron Advanced Derma
SyrSpend® SF
Fagron Aseptic Pack
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Major achievements in 2014
• Gross margin of 64.5%
• EBITDA-margin of
25.4%, an increase of
340bps
• Divestment of Arseus Dental and
Arseus Medical
• US private placement of US$ 185
million
• Refinancing of € 220 million
syndicated loan facility
• Successful rebranding of Arseus
into Fagron
• Fagron publicly listed on Euronext
Amsterdam and Brussels since
1 January 2015
• Organic turnover
growth at constant
rates of 11.5%
• Total turnover growth of
30.4%
• Disposal of € 10.9
million non-strategic
OTC and Industry
activities
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What is pharmaceutical compounding?
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Patient
Tailor-made
medication
Compounded in community and hospital pharmacies or by Fagron
Compounding Services, always based on a pharmaceutical formulation
Formulations developed by Fagron
and/or compounding pharmacists
based on APIs which are out of patent Alternative dosage
forms
Alternative dosage
strengths
Combination
therapy
Key drivers of pharmaceutical compounding
Unique selling points
Prescriber/Pharmacist
“Yes, compounding
pharmacists enhance
medication compliance
and save lives… every
single day!”
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Drug shortages
Discontinued drugs
High-quality and cost effective alternative
Less side effects
More individualised approach
Tailor-made
Enhance patient compliance
New and unavailable therapeutic needs
Increased awareness through internet
Process from prescription to patient – Europe
Patient
REIMBURSEMENT
Prescriber
Hospital
pharmacy
Pharmacy
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Process from prescription to patient – US
Patient
NON STERILE:
REIMBURSED/CASH
Prescriber
Hospital/
clinic
Non-sterile
FCS facility
FDA registered
503B sterile FCS
facility STERILE: CASH 14
Process from prescription to patient – Brazil
100% CASH MARKET
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Patient
Prescriber
Pharmacy
Fagron compouding
advisors
(EU: 300, NA: 100, SA: 100)
Discuss patient case
with prescribers
Tailor-made medication
prepared in a
compounding pharmacy or
by Fagron Compounding
Services
Formulary based on
Fagron APIs and Fagron
Trademarks
Fagron capsule
Win-win-win strategy
Prescriber
Pharmacist
Patient
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Patient
organisations
Government
Insurance companies
Fagron markets – Europe
400,000 pharmacists
155,000 pharmacies
10,000 compounding pharmacies
US$ 2 billion market (est.)
Compounding:
Not embedded
Less important at University and pharmacy education
Regulatory: not-standardised and not implemented
Traditional
Growing market
Estimated market share of FCS is <5%
Estimated market share of FTM and FCE is 50%
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Fagron markets – US
274,000 pharmacists
67,000 pharmacies
4,500 compounding pharmacies
US$ 8 billion market (est.)
Compounding:
Embedded in society and culture
Pharmaceutical specialisation at University level
Regulatory: standardised and implemented, but in transition
Innovative (vehicles)
Growing market
Estimated market share of FCS is <5%
Estimated market share of FTM and FCE is 15%
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Fagron markets – Brazil
120,000 pharmacists
32,000 pharmacies
7,200 compounding pharmacies
US$ 4 billion market (est.)
Compounding:
Way of life, part of Brazilian culture
Pharmaceutical specialisation at University level
Regulatory: standardised and implemented
Innovative (transdermal application)
Growing market
Fagron is not active in FCS
Estimated market share of FTM and FCE is 45%
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Our unique position in global compounding
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Global market leadership
Optimising and innovating compounding
Extensive R&D pipeline
Unique business model
Strong brand names
Global footprint
Global buy-and-build strategy
Our unique position in global compounding
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Group strengths
In-depth compounding knowledge
Use best practices
Speed of execution
Extensive global network
Local market expertise
Acquiring and integrating expertise
Solid financial position
Our unique position in global compounding
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Operational strengths
Global scale benefits
Compliant with highest quality standards
Product portfolio optimisation
Centralised purchasing
Production efficiency
Consolidation of activities
Acquisition of AnazaoHealth Corporation
Leading nuclear, pain and
intrathecal compounding
facility in the United States
Estimated sales AnazaoHealth
in 2015 USD 30 million with
EBITDA margin equal to
Fagron Group
Acquisition multiple 6x
EBITDA
Headquartered in Florida with
an additional 503B facility in
Nevada
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Nuclear compounding
Definition: nuclear compounding is a specialty area of
pharmacy practice dedicated to radioactive materials for
use in nuclear medicine procedures, which includes cancer
treatments and diagnostics.
Radiopharmaceuticals are radioactive. Radiation protection
during compounding and administration forms an integral
part of the job.
Anazao’s radiopharmaceuticals are tailor-made
compounded. Most radioactive dosage forms are being
compounded as capsules, seeds or injections.
Radiopharmaceuticals administered as injections are
compounded under aseptic conditions.
Dosages are compounded in MBq (megabecquerel,
activitiy) instead of milligrams. 25
Radioactive capsules: iodine-131
Thyroid cancer treatment
Indication: iodine-131 is a radioactive therapeutic agent
indicated for the treatment and thyroid carcinomas
(cancer).
Route of administration is oral.
Preparation: radioactive capsules are compounded
according to the prescription and the physicians needs.
Advantage: local treatment, since thyroid cells are the only
cells in the body that can absorb iodine.
Dosage: sodium iodine I-131 therapeutic dose is
thyroid cancer the usual 3700 to 5550 MBq.
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Radioactive injections: Tc-99m
Diagnostics Indication: Technetium-99m is used as a radioactive tracer
for diagnostics and can be detected with equipment for
medical imaging.
Route of administration: intravenous as injection.
Preparation: Tc-99m is taken from a generator and
attached to a carrier, i.e. a protein.
Advantage: Tc-99m protein complex will be absorbed by
tumors, which will identify the tumor on medical images.
Dosage: variable, depending on the amount of activity
needed for the procedure and clarity of the image.
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Radioactive seeds: iodine-125
Brachytherapy
Indication: Treatment of cancer by insertion radioactive
seeds at site of tumor (Brachytherapy).
Route of administration: direct injection into the tumor.
Preparation: Radioactive seeds are loaded into a
needle as strands according to a treatment pattern.
Advantage: local treatment, which affects the tumor
directly without harming many healthy cells..
Dosage: variable, depending on dosage pattern of the
physician.
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Advantages of brachytherapy versus
alternatives
Tailor-made treatment
Local radiation of tumor
Isolated tumor treatment,
without impacting healthy tissue
No invasive surgery needed
Less side-effects (such as
infections, incontinence)
4 hour treatment versus weekly
radiation treatments
Applicable in a.o. cardiology,
oncology, nefrology, neurology
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Fagron Compounding Services
Business model: FCS
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Tablets, capsules, liquids,
crèmes/ointments
IV-Bags, ampoules, vials
TPN, cytostatics, syringes,
cassettes, easypumps
Radioactive capsules,
radioactive injections,
radioactive seeds Nuclear
Aseptic
Non-Sterile
Sterile
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In 2014, Fagron prepared over
2 million prescriptions
Fagron Compounding Services
Fagron Compounding Services facilities worldwide
Belgium
Bornem
(non-sterile & aseptic)
France
Paris (non-sterile)
Marseille (non-sterile)
South Africa
Johannesburg (non-
sterile)
Cape Town
(non-sterile and sterile)
George
(non-sterile and sterile)
Greece
Trikala (non-sterile)
Colombia
Bogotá (non-sterile)
Bogotá (non-sterile)
Cali (non-sterile)
Medellin (non-sterile)
Netherlands
Oud Beijerland (non-sterile & aseptic)
Helmond (non-sterile & sterile)
Hoogeveen (non-sterile & aseptic)
Oldenzaal (non-sterile & aseptic)
Goes (non-sterile, sterile & aseptic)
North America
Wichita, Kansas (sterile & aseptic)
St. Louis, Missouri (non-sterile)
Arlington Heights, Illinois (non-sterile)
Tamarac, Florida (non-sterile)
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Fagron Compounding Services
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Warehouse incoming goods Clean utilities Transfer into clean room
Clean utilities in clean room Batch record administration Transfer to aseptic area
Fagron Compounding Services
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Prepare for compounding Compounding Visual analyses
Packaging Microbiology analyses Complete batch record
Fagron Compounding Services – products
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Elastomeric pump Morphine cassettes
Fagron Aseptic Pack Prefilled syringes
Fagron Compounding Services – products
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Intravitreal eye injections antibiotic prophylaxis
IV bag Cytostatics
Global R&D pipeline
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Launch Global Concepts
FAD phase 2
Pain, phase 1
SDD
FAD phase 3
Obese
Alopecia
May Jun Jul Jan Feb Mar Apr Aug
2015
Sep Oct Nov Dec Feb
2016
Aug
Psoriasis
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YES, WE IMPROVE THE QUALITY OF
LIFE OF PATIENTS, EVERY SINGLE DAY
Financial highlights 2014
Consolidated turnover S2 2014 and FY 2014
X 1,000 euros 2014 2013 Total
growth
Tot. growth
CER Org.
growth
Org.
growth
CER
Fagron 438,479 334,985 30.9% 33.0% 9.7% 11.5%
HL Technology 8,577 7,726 11.0% 9.5% 11.0% 9.5%
Total 447,056 342,711 30.4% 32.5% 9.7% 11.5%
X 1,000 euros S2 2014 S2 2013 Total
growth
Tot. growth
constant* Org.
growth
Org.
growth
constant **
Fagron 234,348 176,828 32.5% 31.0% 10.4% 9.1%
HL Technology 3,559 3,317 7.3% 4.9% 7.3% 4.9%
Total 237,908 180,145 32.1% 30.5% 10.4% 9.1%
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Sales Fagron - division CAGR
42 CAGR: Compound Annual Growth Rate
137 151
179
243
290
335
438
2008 2009 2010 2011 2012 2013 2014
20%
Organic and total turnover growth Fagron division
9.4%
5.9% 7.2% 6.5%
10.9%
13.7% 11.5%
24.2%
10.5%
18.3%
35.8%
21.8%
20.3%
33.0%
0%
5%
10%
15%
20%
25%
30%
35%
40%
2008 2009 2010 2011 2012 2013 2014
Total growth at constant rates
Organic growth at constant rates
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Sales per segment
x 1,000 € 2014 2013 Total growth Organic
growth
Fagron Compounding
Services 147,780 58,210 153.2% 19.8%
Fagron Trademarks 45,652 33,630 39.8% 28.4%
Fagron Compounding
Essentials 245,047 243,145 3.3% 4.7%
Total Turnover 438,479 334,985 33.0% 11.5%
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Without the disposal of € 10.9 million of Industry
Sales, organic growth of Fagron Compounding
Essentials would have been 9.7%
Consolidated - Gross Margin
194.7
288.2
0
50
100
150
200
250
300
2013 2014
49.2%
48.1%
• Increased by 770bps to 64.5% of
turnover
• Focus on high margin products, FCS
and Fagron™
• Continuous savings in procurement
• Phased-out industry sales
56.8%
64.5%
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Consolidated - REBITDA
79.1
118.5
0
20
40
60
80
100
120
2013 2014
49.2%
49.8%
• Increase of 340bps to 26.5% of
turnover
• Continuous focus on OPEX
• Growing expenses in R&D
• In 2014 total amount of R&D is € 30
million
• Fagron does not activate R&D costs
23.1%
26.5%
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Consolidated - Depreciation & Amortisation
8.9
19.0
0
2
4
6
8
10
12
14
16
18
20
2013 2014
49.2%
113.4%
• Increase in D&A of € 10.1 million:
€ 4.7 million PPA
€ 2.6 million PPE
€ 2.8 million write down of
inventory and receivables (phase
out of non profitable distributions
and industry sales)
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Consolidated – EBIT
66.3
94.3
0
10
20
30
40
50
60
70
80
90
100
2013 2014
49.2%
42.2%
• Increase of 42.2% to € 94.3 million
(170bps to 21.1% of turnover)
• EBIT lift (EBIT growth/sales growth)=
1.39
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Consolidated – Taxes
7.0
26.7
00
05
10
15
20
25
30
2013 2014
49.2%
• Increase of € 19.7 million, mainly due
to high corporate tax rate in the US
• Effective tax rate amounted to 38.2%
• Cash tax rate is 16.3% and below our
guidance of 20%
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Consolidated – Adjusted net profit
44.3 46.7
62.0
00
10
20
30
40
50
60
70
2013 2014 2014adjusted
49.2%
5.4%
• Increase of 5.4% from € 44.3 million
to € 46.7 million
• Negatively impacted by high tax rate
• Net profit corrected for paid taxes
would be € 62 million (increase of
40.0%)
40.0%
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Net financial debt – S1 and S2
327
411
289
449
0
50
100
150
200
250
300
350
400
450
500
2013 2014
S1 S2
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• Negatively impacted by USD
conversion (effect is € 22.2 million)
• Covenant = 3.18 compliant with
maximum ratio of 3.25
Net debt bridge
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449
289 107
197
21 19 22 1 1 25
22
00
50
100
150
200
250
300
350
400
450
500
Strongly improved cash flow generation
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In million € 2014 2013 Change
Operating cash flow 93.9 46.0 +104%
- Interest -24.7 -19.4 +27%
- CAPEX -12.5 -5.2 +140%
Free cash flow 56.7 21.4 +165%
EBITDA 113.4 75.2 +51%
EBITDA/FCF 50% 28% +2,200bps
Strongly improved cash conversion
Due to increasing EBITDA, good working capital management and decreasing
paid taxes = ‘Operational excellence’
Fagron Statutaire jaarrekening 2014
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Verkorte enkelvoudige resultatenrekening
X 1.000 euro 2014
Bedrijfsopbrengsten 5.068
Bedrijfskosten -2.577
Bedrijfswinst 2.491
Financieel resultaat 40.044
Winst uit gewone bedrijfsuitoefening voor belasting 42.535
Uitzonderlijk resultaat
Winst van het boekjaar voor belasting 42.535
Belasting op het resultaat
Nettowinst boekjaar 42.535
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Verkorte enkelvoudige balans
X 1.000 euro 2014
Vaste activa 393.760
Vlottende activa 242.961
Totaal activa 636.721
X 1.000 euro 2014
Eigen vermogen 359.482
Voorzieningen en uitgestelde belastingen 5.751
Schulden 271.488
Totaal passiva 636.721
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Enkelvoudige resultaatverwerking
X 1.000 euro 2014
Te bestemmen winstsaldo 44.117
Onttrekking aan het eigen vermogen
Toevoeging aan het eigen vermogen 12.961
Aan de wettelijke reserves 2.127
Aan de overige reserves 10.834
Over te dragen resultaat
Uit te keren winst 31.156
Voorstel brutodividend (nettodividend) per aandeel (in euro) 1,00 (0,75)
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Outlook
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Outlook 2015
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Fagron expects to realise a turnover from
continuing operations of at least € 500 million1
with a REBITDA-margin2 from continuing
operations of 26%
1 Based on constant exchange rates (euro/US dollar of 1.250 and euro/Brazilian real of 3.100). 2 EBITDA before non-recurrent result.
Thank you
Disclaimer
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This presentation may contain forward-looking statements with respect to Fagron’s future
(financial) performance and position. Such statements are based on current expectations,
estimates and projections of Fagron and information currently available to the company.
Fagron cautions readers that such statements involve certain risks and uncertainties that
are difficult to predict and therefore it should be understood that many factors can cause
actual performance and position to differ materially from these statements. Fagron has no
obligation to update the statements contained in this presentation, unless required by law.
A more comprehensive discussion of the risk factors affecting Fagron’s business can be
found in the company’s latest Annual Report, which can be found on the company's
corporate website, www.fagron.com.