Roadshow London - Fagron

67
Ger van Jeveren, CEO Marieke Palstra, IR Roadshow London 17-18 February 2015

Transcript of Roadshow London - Fagron

Page 1: Roadshow London - Fagron

Ger van Jeveren, CEO

Marieke Palstra, IR

Roadshow London

17-18 February 2015

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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

Global market leader in pharmaceutical compounding

2,239 employees, incl. >300 pharmacists, in 30 countries

19 compounding facilities, 6 facilities under development,

5 conditioning sites, 3 purchase and audit offices

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

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

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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

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Win-win-win strategy

Prescriber

Pharmacist

Patient

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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 13

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Process from prescription to patient – Brazil

100% CASH MARKET

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Patient

Prescriber

Pharmacy

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Win-win-win strategy

Prescriber

Pharmacist

Patient

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Patient

organisations

Government

Insurance companies

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Financial highlights

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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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Consolidated - Gross Margin

194.7

288.2

0

50

100

150

200

250

300

2013 2014

49.2%

48.1%

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• 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%

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• 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%

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• 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%

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• 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%

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• 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%

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• 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 2014S1 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

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Net debt bridge

25

449

289 107

197

21 19 22 1 1 25

22

00

50

100

150

200

250

300

350

400

450

500

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Balance sheet: Assets

47.5 60

400.6

575.3

28.3

22.4

15.8

5.1

33.0

48.2

40.3

63

0

100

200

300

400

500

600

700

800

900

Dec 2013 Dec 2014

Assets/liabilities held forsale*

OWC

Other fixed assets

Deferred tax assets

Intangible assets

Tangibles

* Excluding net debt for discontinued operations. 26

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Balance sheet: Liabilities

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155.2 156.9

13.5 14.9 4.5 6.2

289.2

448.7

2.5

3.1

100.7

139.7

0

100

200

300

400

500

600

700

800

900

Dec 2013 Dec 2014

Other WC

Financial instruments

Net financial debt

Deferred tax

Provisions

Equity

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Strongly improved cash flow generation

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In € 1,000 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’

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Fagron

FINANCIAL HIGHLIGHTS

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Sales Fagron CAGR

30 CAGR: Compound Annual Growth Rate

137 151

179

243

290

335

438

2008 2009 2010 2011 2012 2013 2014

20%

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Organic and total turnover growth

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

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%

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Fagron Compounding Services

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Business model: FCS

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Sterile

Aseptic

Non sterile Tablets, capsules, liquids,

crèmes/ointments

IV-Bags, ampoules, vials

TPN, cytostatics, syringes,

cassettes, easypumps

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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

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Fagron Compounding Services

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Prepare for compounding Compounding Visual analyses

Packaging Microbiology analyses Complete batch record

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Fagron Compounding Services – products

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Elastomeric pump Cassettes

Fagron Aseptic Pack Prefilled syringes

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Fagron Compounding Services – products

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Intravitreal eye injections antibiotic prophylaxis

IV bag Cytostatics

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YES, WE IMPROVE THE QUALITY OF

LIFE OF PATIENTS, EVERY SINGLE DAY

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Fagron Trademarks

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SyrSpend® SF

SUPERIOR SUSPENDING TECHNOLOGY

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Development of SyrSpend® SF

Invented by Fagron USA

SyrSpend® SF was designed as an ideal

suspending vehicle1

Technology patented in US

Developed to compete with the leading commercially available

suspending bases

Designed with focus on use in vulnerable patients

Fagron continually performs physical, chemical and microbiological

stability studies on SyrSpend® SF / API combinations

SyrSpend® SF is used by Sanofi and Astellas for clinical trials

1 Thompson JE. A Practical Guide to Contemporary Pharmacy Practice, Lippincott Williams & Wilkins, Baltimore, Md., 1998, p. 28.1 43

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Suspensions

Suspensions are heterogeneous mixtures containing

solid particles in a liquid phase

Suspensions are extensively used because

1. Most APIs are partly or totally insoluble in water

2. Some APIs are chemically instable in solution

3. Suspensions cause less taste issues

If left untouched suspensions will eventually settle,

forming a solid ‘cake’ on the bottom

SyrSpend® SF’s active suspending technology prevents

caking

Solution

Suspension

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What makes SyrSpend® SF unique

SyrSpend® SF is based on modified food starch, which gives it its

unique features

Active suspending technology:

• High viscosity at rest keeps the API safely suspended

• Low viscosity when shaken eases rehomogenisation

Ensuring high dosing accuracy and consistency throughout treatment

Avoidance of ingredients, such as methylcellulose or sorbitol, that can

cause allergic reactions and gastrointestinal side effects

Broad compatibility with APIs, as starch is practically inert for chemical

reactions

Pleasant neutral flavour and mouth-feel

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SyrSpend® SF for any situation

SyrSpend® SF Alka is an unique product in the market!

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Packs contain

SyrSpend® SF (dry, for reconstitution) in a validated dispensing

container

Pre-weighed API powder

Oral syringe

Tip extender

Press-in bottle adapter

Compounding instructions

Convenient packs

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Fagron Advanced Derma

LEADING ADVANCED DERMATOGICAL CARE

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Total solution for dermatology

A total solution for

Tailor-made prescription compounding

Basic skin care

Based on

Vehicle design according to the latest

scientific insights into the safety and

tolerance of topically applied ingredients

Different bases for different skin types

Suitability for vulnerable, sensitive skin

Optimal compatibility with APIs and DCIs

Compounding and prescribing formulary

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Ingredient safety

Various classic dermatological/cosmetical

products contain undesirable ingredients

Harmful effects confirmed by scientific

knowledge (e.g. allergic reactions)

Use by vulnerable patient groups

Fagron Advanced Derma is free of harmful

ingredients

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Unique advanced vehicles

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Especially suitable for Especially suitable for Especially suitable for

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Resources for prescribers

Indication-specific formularies

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Resources for pharmacists

Vehicle-specific formularies

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Prescribers worldwide: compounding prescriptions based on Fagron vehicles

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R&D

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Development

Realisation

Launch of

solution

Patient, pharmacist

& prescriber

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Global R&D pipeline

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Launch Global Concepts

FAD phase 2

Pain, phase 1

SDD

FAD phase 3

Obese

Alopecia

Global formulations App

May Jun Jul Jan Feb Mar Apr Aug

2015

Sep Oct Nov Dec Feb

2016

Aug

Psoriasis

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Quality management

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The unique quality of Fagron

Fagron is taking every step necessary to

provide the best Quality for more than

200,000 customers worldwide:

Fagron has a China/India Office fully

dedicated to Quality

Fagron realised 1,200 Supplier Qualifications

in Global QIS by end 2014

Fagron performed 350 Audits by certified

Fagron Auditors by end 2014

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Assure high quality of

raw materials from China

and India by performing

supplier qualifications

and on-site audits

Fagron China/India quality and procurement office

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Quality control in entire supply chain

A guaranteed high quality across the entire supply chain

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Global quality intelligence system

Global QIS is a 24/7 worldwide accessible system, which ensures a

harmonised way of performing supplier qualifications (SQ’s) and

completing audit reports

By tracking OOS and complaints worldwide and linking them to the

producer, Fagron performs vendor management

Global QIS provides a complete quality overview from producer to end-

customer

SQ’s

WC’s

Audits

Recalls

Warnings

QC

data Technical

files Com-

plaints

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Stability & compatibility studies

Different studies performed with

Fagron Trademark products

Stability studies (shelf life: physical

and microbial stability)

Physical compatibility studies with

API (appearance, colouring or visual

viscosity)

Chemical compatibility studies with

API (quantitative degradation in API)

In vitro absorption studies

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Outlook

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Outlook 2015

Fagron expects a turnover of at least € 500

million with an REBITDA margin of 26% in 2015

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Thank you

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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.

The FY14 are not audited numbers and therefore final 2014 numbers may deviate from the

numbers presented.

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.