Acino ? Delivering Health

Acino – Delivering Health 

Investor Day 2012 

Aesch, December 5, 2012 

Acino Holding Ltd. 

Erlenstrasse 1 | CH-4058 Basle | www.acino-pharma.com 

Phone +41 61 338 60 00 | Fax +41 61 338 60 80

Agenda 

09:30 – 12:30 Welcome Robert Schmid 

12:30 - 14:00 Lunch 

Acino - leading in technologies Dr. Jean-Daniel Bonny 

How our pipeline boosts growth Dr. Jean-Daniel Bonny 

Coffee break 

Successful in emerging markets in BtC Ruud van Anraat 

How to escape price pressure in BtB Ruud van Anraat 

Technical marketing and operations: 

Strategy and opportunities Dr. Jürgen Betzing 

14:00 - 16:00 Facility tour (production / QC labs) 

16:00 - 17:00 Financials Robert Schmid 

Summary and strategy Peter Burema 

2

Acino – drug delivery specialist, 

marketer and partner 

The Acino Group is headquartered in Basle, currently employs approximately 850 staff and 

generated annual net revenues of about EUR 129 million in the first half-year 2012. Acino 

Holding Ltd., the Group’s parent, is listed on the SIX Swiss Exchange (SIX: ACIN). 

Acino is specialized: on the development, registration, manufacture and marketing of 

established and innovative pharmaceuticals using advanced and refined drug delivery 

technologies. 

Under the brand “Acino Switzerland”, Acino markets Swiss-quality medicines in up and coming 

economies, currently in 80 countries in the Middle East, Africa, Latin America and Asia. 

Acino continues to evaluate both opportunities for organic growth and acquisitions at a 

strategic and operational level, so as to advance its market position as a leading provider of 

pharmaceutical specialties 

3

Acino’s business strategy 

BtB - Outlicensing 

Accelerate growth 

Acquisitory growth through targeted M&A activities 

Organic growth initiatives based on existing opportunities 

BtC - Acino Own 

Brand Marketing 

Technology Marketing 

4

Acino’s growth drivers 

Fully exploit product 

potential 

Expand global reach 

Broaden the product 

portfolio 

Customer base 

expansion 

Acquisitory growth 

Across all businesses 

External impulses 

BtC BtB Technology mktg 

Roll out BtB products in 

the existing BtC markets 

Access new markets 

(e.g. CIS) 

Strong development pipeline 

(tailored to both BtC and BtB markets) 

Inlicensing products 

Targeted M&A activities 

Exploit potential of BtC 

products in BtB markets 


(e.g. USA, Japan) 

Start co-developments 

projects (non-exclusive) 

Broaden customer base, 

new acquisition 

Lead project (Bayer) 

nearing market readiness 

Other customer projects 

under way (exclusive) 

New customer acquisition 

based on technological 

strengths 

Operational excellence: high investments, exploit synergies & untapped potential 

Population / GDP growth in 

emerging markets 

Numerous patent expires Market values product 

differentiating features 

5

Leading in Technologies 

Development Projects and Pipeline 

Dr. Jean-Daniel Bonny, Head R&D Acino Group 

December 5, 2012 

Aesch 

6

Technology platform 

Oral modified release forms 

7


Pellets loaded with active ingredient 

Innovative technologies for developing and manufacturing multiparticulate systems 

with a high drug content 

Exclusive license to certain unique technologies developed together with INNOJET 

Herbert Hüttlin ® 

Layered pellet 

Matrix pellet 

Starter particle 

API-core 

Film coating 

Functional 

coating 

Intermediate layer 

Core (contains API) 

manufactured by 

extrusion / 

spheronisation 

8


MUPS (Multiple Unit Particle System) 

MUPS (Multiple Unit Particle System) dissolve after intake into a multitude of subunits 

(for example pellets), which are ultimately responsible for the release of the active 

ingredient 

Computertomographic cross 

section through a MUPS 

Water-soluble 

film coating 

Pellet with: 

Sugar core 

Active ingredient 

Acid-protective coating 

MUPS dissolution 

MUPS-tablet before dissolution 

MUPS-tablet after dissolution into sub-units 

9


Advantages of multiparticulate dosage forms 

Gastric transit time of pellets is largely independent of filling degree and motility of 

the stomach 

Pellet-filled capsules rapidly disperse in the GIT thereby avoiding high local 

concentrations of the active substance which often causes irritations 

High flexibility: Pellets composed of different active ingredients or release rates can 

be easily blended 

10


Oral dispersibles 

Oral dispersibles are loaded with an active ingredient and are suitable for 

application to the oral cavity 

Active ingredient can be dissolved or suspended in the polymer matrix 

Our technology focuses on rapidly dissolving tablets (ODTs), films (ODFs, thin 

polymer films) and pellets (in stick packs) 

Oral dispersible film (ODF) Pellets in stick packs Stick packs 

11

Oral dispersibles 

Advantages 

Oral dispersibles offer numerous advantages: 

They can be easily administered without liquids 

Ideal drug delivery form for active ingredients with a high first pass effect which may 

be bypassed with a possible buccal absorption 

Rapid onset of action thanks to a quick dissolution of the films 

Due to the adhesion on the oral mucosa, spitting out the films is not possible 

These characteristics predestine ODFs for use in pediatric, geriatric 

and veterinary medicine. 

12


Transdermal systems (TDS) 

13

Transdermal systems 

Why transdermal application? 

Advantage: Reproducible & constant blood levels 

One tablet three times daily One transdermal system 

Conc. Conc. 

Time 

Time 

14


Why transdermal application? 

Further advantages of transdermal drug 

application 

Drug input is easily interrupted by removal 

of the patch 

Amount of drug uptake can be controlled via 

patch size; application for up to 1 week 

feasible 

Application free of pain and simple onto the 

skin 

Potential for higher bioavailability due to 

bypassing of gastrointestinal tract and liver 

metabolism; fewer irritations of the 

gastrointestinal tract 

Significant improvement of patient 

compliance, especially in elderly persons 

15


Acino’s competence in development 

Proven know-how in formulation development of transdermal dosage forms: 

– 1 st therapeutic option to Transtec ® PRO for transdermal pain therapy with 

buprenorphine in dosage strengths 35 µg/h, 52.5 µg/h and 70 µg/h 

– Successfully focusing on innovative formulations with low drug load 

State of the art capabilities to reproducibly prepare and characterize formulations 

under development 

Analytical development for all quality tests, including method validation 

Manufacturing process development and transfer to GMP facility 

Manufacture of clinical supplies for Phase I to III on same/equivalent equipment 

targeted for commercial supplies 

16


Extended release parenterals 

17


Biodegradable subcutaneous implants 

Drug implants are monolithic rods (length of 1-2 cm and a diameter of 1-2 mm) 

containing the active ingredient embedded into a biodegradable polymer matrix 

(poly-lactide-co-glycolide) as a carrier substance. 

Physicians apply them with a commercially available standard syringe under the skin 

(subcutaneous). 

Technologies 

Melt extrusion 

(monolithic implants) 

Dosage forms 

Biodegradable subcutaneous 

drug implants 

18


Advantages of drug implants 

Continuous and steady drug release over a defined time period (1 to 6 months) 

Patient continuously medicated as prescribed 

Monthly, quarterly or half-yearly application (long dosing intervals, even 

exceeding those patches) 

With regard to comfort, patient compliance and continuous release of the active 

ingredient, subcutaneous biodegradable implants offer similar advantages as 

transdermal therapeutic systems 

19

Development projects 

Oxycodone matrix 

Characteristics 

– No dose dumping in alcohol – no risk of accidental overdosing 

– Lower COGS compared to MUPS 

– Wide coverage of dosage strengths for aligned medication 

5, 10, 15, 20, 30, 40, 60, 80 mg 

– Colored tablets with printing of dosage strength 

– Appearance (printing in development, 80 mg as a preview) 

Status 

– 9 DCPs submitted to BfArM in Aug 2012 

– Approval expected for end 2013 

Further steps 

– (Co-)development of 120 and/or 160 mg strength is in discussion with various 

customers 

20


Ferrous sulfate 


– 100 mg Fe2+ per capsule 

– Used API: Ferrous sulfate, dried 

– Capsule: white and red with imprinting 

– Packed in blisters 

– Excellent addition to Acino’s inlicensed injectable iron product 

Indications (EU) 

– Treatment of patients (adults and children ≥ 6 years) iron deficiency with and 

without development of anemia 

Reference product 

– Dosing regimen will be similar to other oral iron products on the German market, 

e.g. Ceferro ® 100 

Status 

– No clinics necessary 

– First national approval expected Q4-2014 

21


Rivastigmine TDS 1 day 


– Indication: Symptomatic treatment of mild to moderate Alzheimer dementia 

– Transdermal system for 1 day application 

– 2 strengths: 4.6 mg/24 h and 9.5 mg/24 h 

Acino's timeline for target markets EU and US 

– EU: Day 106 granted, launch expected Q1-2013 

– US: ANDA accepted, launch expected Q1-2016 (depending on ANDA litigation) 


– Exelon ® Patch (Novartis) 

Competitor situation 

– SK Chemicals Korea expect launch in EU in Q1-2013 

Life cycle management activities 

– Development of additional higher strength (13.3 mg/24 h) ongoing 

22


Rivastigmine TDS 1 day 

23


Fentanyl (low load) EU & US 


– Monolayer transdermal system for delivery over 3 days 

– 12 µg/h, 25 µg/h, 50 µg/h, 75 µg/h, 100 µg/h dosage strength 

– Low drug load of Acino’s patch allows to submit in US and EU: 

> Smaller and less drug load (< 50%) compared to Durogesic ® SMAT 

> Release of about 90% of total drug (compared to about 40% of reference) 

– Risk for drug abuse significantly reduced 

– Lower COGS 

Status 

– Pivotal trials planned for May 2013 

– Submission in EU June 2014 

24


Goserelin & leuprorelin implants 

The implant The application system 

14 - 22 mm 

Ø 1.2 – 1.5 mm 

Medication 

Subcutaneous injection 

Active pharmaceutical ingredient (API) in biodegradable matrix 

Release of API within 1 or 3 months 

Advantages of Acino’s products 

Covering two different treatment durations 

Easy-to-handle / easy-to-apply product(s) 

Small volume of injection (< 0.05 ml) and largely painless application 

25


Goserelin 1 & 3-month implant 

Target indication 

– (Advanced) prostate cancer (palliative treatment): Sixth leading cause of 

cancer-related death in men (globally), in the US it is the second 

– Breast cancer (1-month product, only) 

Acino’s timeline for target markets 

– Goserelin 1M launches in certain ROW markets end 2012/2013 

– Launch EU Q1-2015 (1-month product) 

– Launch EU Q1-2016 (3-month product) 


– Zoladex ® (Astra Zeneca) 

Competitor environment 

– No generic product of goserelin on the market 

– Only one competitor with implant in clinical phase 

26


Goserelin 1 & 3-month implant 

27


Leuprorelin 1 & 3-month implant 

Target indication 

– Prostate cancer 

Acino's timeline for target markets US and EU/ROW 

– Launch EU Q1/Q2-2016 

– Launch US Q4-2016 


– Enantone ® / Trenantone ® (Takeda) → Microparticle formulation 

– Implant has potential advantages compared to microparticles: 

> Easy preparation of injection (no reconstitution) 

> Less painful application 

> Less drug burst 

> Easier removal in case of adverse reactions 

Competitor situation 

– Only one implant formulation marketed (not in US) 

– Only one competitor with implant in clinical phase 

28


Leuprorelin 1 & 3-month implant 

29

Acino makes use of synergies in 

various niches 

-Ferrous sulfate 

-Food supplements 

-Sildenafil stick packs 

-Inlicensed 

products 

Technology 

-FC Patch Bayer 

-Fentanyl 

low load EU&US 

-Leuprorelin 

1M & 3M 

-Rivastigmine 

TDS EU&US 

-Goserelin 1M & 3M 

-Oxycodone matrix 

-Alfuzosine 

-Doxazosine 

-Itraconazole 

BtC Opportunities Niche BtB / BtC 

30

Acino’s development pipeline 

Status November 2012 

27 

Number of Acino own 

projects by stage 

31

Acino’s estimated approval dates 


32


Thank you for 

your attention 

33

Successful in emerging markets in BtC 

How to escape price pressure in BtB 

Ruud van Anraat, CCO Acino Group 


Aesch 



Phone +41 61 338 60 00 | Fax +41 61 338 60 80

Entering emerging markets / 

“Swissness“ 

Many markets, especially in the Acino target regions, are still dependent on 

imported pharmaceuticals and/or acceptance of locally produced products is 

low 

– High medical need for valued-added products/niche specialities with high quality 

background from CH/EU sources 

Acino’s target markets have a low acceptance of products out of India/China 

vs. high valued Swiss/EU origin 

– Market research results show highest perception of Swiss origin products in 

general of pharmaceuticals in particular in almost all target markets. EU origin 

products (preferably “Made in Germany”) are highly valued as well 

High “Swiss” pharmaceutical brand awareness heritage 

– Mepha has created a high value “Swiss” brand equity that can be more easily 

transferred to “Acino Switzerland” brand due to a high overlap of shared values 

35

Swissness profile: merging Mepha into 

Acino Switzerland 

36

Acino Switzerland 2009 

BtC markets 

Established markets 

37


BtC markets 


38


BtC markets 


39


BtC markets 


40


BtC markets 


Expected markets 

41

Entering emerging markets - 

hurdles to overcome 

Entry of emerging markets 

– Highly fragmented regulatory environment 

> Increased requirements for stability (Zone IVB) 

> Local bioequivalence / clinical studies required 

> Trends toward local production 

> Limited uptake of alternative generic products by authorities 

Market environment 

– Market size 

– Many markets are flooded with cheap commodities (Indian/Chinese/local origin) 

– Many markets are dispensing markets (low quantities/low turnover) 

– Patients pay out of their own pocket, decision making done by physician/patient 

(brand equity) 

42

Opportunities 

Products with added value 

– Generics + 

– Products with application/compliance advantages (AOD, patches, implants) 

– Niche products (few competition) 

Therapeutic areas 

– Life threatening and related diseases (cancer, Aids, Malaria) 

– Life-style products (Sildenafil, herbals) 

– Upcoming western diseases (obesity, diabetes) 

– Women healthcare 

43

Acino Switzerland: 

Product Portfolio 

Brand name* 

Active ingredient/ Dosage form Basic registration 

Pain FENTAVERA 

Fentanyl/TDS EU 

OXYCONICA 

BUVERA 

HYDRONICA 

Oxycodone/MUPS tablet EU 

Buprenorphine/TDS EU 

Hydromorphone/CR capsule EU 

PARACONICA 

Paracetamol/solution for i.v. perfusion EU/CH 

Oncology GOSACIN 

Goserelin/Implant CH 

ZOLACIN 

Zolendronic acid/solution for i.v. perfusion EU/CH 

* Might be subject to local/regional adaption. 

Acino respects the property rights of third parties, therefore developments and products are only offered under the condition that 

they are not in violation of third-party rights or only in countries where such rights do not apply. 

44

Acino Switzerland: 

Product Portfolio (cont’) 

Active ingredient/Dosage form Basic registration 

Cardiovascular CLOPACIN 

Clopidogrel/Film tablet CH 

Urology 

Anti-Mycotic 

CNS 

GI 

Vitamins&Co 

Brand name* 

METRACIN 

AMLOCIM 

NEBIVACIN 

DOXACIN 

FUZOCIM 

ITRACIM 

LEVACIN 

PANTOCIM 

ESPRACIM I.V. 

FERRACIN I.V: 

Metoprolol (-succinate)/MUPS SR tablet CH 

Amlodipine (-besylate)/Tablet CH 

Nebivolol/Tablet CH 

Doxazosine/SR tablet CH 

Alfuzosine/SR tablet CH 

Itraconazole/Capsule CH 

Levodopa/Carbidopa/SR tablet CH 

Pantoprazole/Powder for solution (i.v.) EU/CH 

Esomeprazole/Powder for solution (i.v.) 

Iron-Suc./Solution for i.v. perfusion 

* Might be subject to local/regional adaption. **Brand names still tbd. 

Acino respects the property rights of third parties, therefore developments and products are only offered under the condition that 

they are not in violation of third-party rights or only in countries where such rights do not apply. 

EU 

EU 

45

Acino Switzerland Brands ® 

46

Acino portfolio 

Roll-out in new territories 

Use synergies of local organizations to further promote/launch Acino portfolio 

products in already established markets 

– MENA: Iraq, UAE, Kuwait, Jordan, Lebanon 

– Sub Sahara Africa 

Actively push pending and new registrations in high potential markets already 

established via the former Mepha/Cephalon 

– MENA: KSA, FWA, Algeria etc. 

– Africa: Kenya, Uganda, Tanzania, Sudan, RSA, etc. 

– LATAM: CAC, Ecuador 

Find opportunities and register in new markets 

– Asia: Vietnam, Thailand, Philippines, Indonesia, Cambodia 

– CIS: Ukraine, Kazakhstan, etc. 

– LATAM: Peru, Bolivia, Colombia, etc. 

47

Portfolio extension by in-licensing 

Objective: 

either to support its own branded commercialization (BtC) 

or to support its out-licensing position (sub-licensing) 

Advantages: 

Quick access to products 

More cost effective solution versus own development and less financial risk 

Continuous flow of new products 

More flexibility 

To have a continuous in-flow of profitable 

licensing products – at the right time, in the right 

place, and at the right price – that will ensure 

Acino’s growth over the years to come. 

48

Criteria for selecting products for 

in-licensing 

Fit to therapeutic class (e.g. CNS, uro-oncology, pain) 

Growing therapeutic areas and molecules with high growth 

potential (example: life style and modern diseases) 

Niche products (e.g. pantoprazole inj., esomeprazole inj) 

Specific market demand (e.g. iron sucrose, zoledronic acid) 

Increased Priority 

49

Acino’s in-licensing portfolio 


. 

Under evaluation 

Celecoxib Oral 

Pain 

Rosuvastatine Oral 

Statine 

Levofloxacine Oral 

Antibiotic 

Levofloxacine I.V. 

Antibiotic 

Esomeprazole Oral 

Gastrointestinal 

5 

Rights obtained 

Agreement signed 

Esomeprazole I.V. 


Teicoplanine IV 

Antibiotic 

Anastrazole Oral 

Cancer 

Under registration in EU Ready for local submission 

3 2 2 

Legend: 

Oral 

Paracetamol I.V. 

Pain 

Pantoprazole I.V. 


Oral 

dispersible 

TDS Implant 

Zoledronic Acid I.V. 

Cancer/osteoperosis 

Iron Sucrose I.V. 

Iron deficiency 

NCE (new 

chemical 

entity) 

I.V. 

50

Acino’s business model (example) 

Acino is committed, in cooperation with all stakeholders and partners involved, to supply 

genuine Acino products in the best quality and under optimal delivery conditions 

Acino 

products 

Mepha 

products 

Cephalon 

products 

Partner 

Scientific Drug Bureau 

Distributors / 

Wholesalers 

Ministry of Health 

Dedicated Acino 

Sales Force 

Physicians & 

Pharmacies 

Patients 

51

Optimizing BtB concept 

Price Pressure – What we are doing to optimize earnings: 

Identify Unique Selling Points and address them during development to create 

more value added products using advanced drug delivery systems 

– New formulation, easier to apply (e.g. small implant instead of bulky emulsion) 

– Prolonged release formulation (e.g. to administer once a day instead of three 

times daily) 

Selection of business partners with marketing conceptions not based on 

lowest price strategy 

– Looking for local specialists, e.g. pain companies suitable to Acino’s pain 

portfolio, with branded product strategies 

Differentiated country specific pricing with one partner 

– Dedicated selling prices for low price countries and high price countries 

52

Optimized BtB Concept – 

Geographical expansion 

2002 

2004 

2008 

2009 

2011 

2012 

Acino (former Cimex) has mostly German partners 

Acino (former Cimex) partners mostly with companies in Europe 

Acino contracts with US companies 

– License agreements with US companies (Fentanyl TDS, Rivastigmine TDS) 

– Negotiations with several other US companies concerning license deals 

Acino starts expansion to Japan 

– License agreements with Japanese companies signed (Gosereline Implant) 

– Development and supply agreements signed 

Acino increases expansion activities to China and India 

– Negotiations with Chinese and Indian companies concerning license deals 

Acino outlook: intensified expansion 

– Collaboration agreement with Japanese company in late negotiations 

– Licensing deals with China and India to be closed 

– Expansion in LATAM, Brazil, and Mexico in the works 

– Implants for the US in planning 

53


Thank you for 


54

Technical Marketing and Operations: 

Strategy and opportunities 

Dr. Juergen Betzing, COO Acino Group 


Aesch 

55

Manufacturing sites 

Technology Center Solids 

Liesberg 

Solid oral dosage forms 

European large volume customers BtB 

Aesch Dornacherstrasse 

Solid oral dosage forms 

Smaller volume specialties for flexible supply of BtC customers 

Aesch Pfeffingerring 

Consolidated packaging 

Technology Center Transdermals/Implants 

Miesbach 

Transdermal specialities and implants 

56

Acino’s production importance 

Tech Center Solids is one of the top manufacturing sites for pellets 

Most likely number one for pellet technologies in Europe 

Capacity: approx. 3.5 billion units/year 

Tech Center Transdermals/Implants is the second largest manufacturer for patches 

in Europe 

In addition, for opiates Acino is the largest patch manufacturer in Europe 

Capacity: approx. 100 million patches/year 

For implants the site in Miesbach is one of the most modern in Europe 

Capacity: approx. 200 000 implants/year 

57

Technology Marketing: Strategy 

Organization 

Core competencies 

Service spectrum 

Cost leadership 

Economic advantage over 

competitors 

Customers 

Expectations for added 

value 

Competitive 

Advantage 

Competition 

Competitive field 

Service spectrum of 

competitors 

Differentiation 

Focus on niche 

technologies 

Broad equipment park 

Expertise for difficult-tomake 

products 

Swiss quality 

58

Production Technologies: 

Value for our Customer 

Why would customers choose Acino as a partner? 

Strong know-how in difficult-to-make 

formulations 

State- and top-of-the-art 

technologies/equipment 

Fully equipped to serve all possibilities 

inside the core technologies 

Full service and intense hand-in-hand 

work to support the customers 

High quality standards and philosophy 

High delivery service 

Flexible in time-to-volume 

Problem solutions for our customers 

Long-term focused relationship 

59

Acino’s technology portfolio today 

Granulates 

Patches 

Pellets 

Large variety of drug 

delivery forms 

requires broad-based 

technological know-how 

and manufacturing 

competence 

Implants 

Microtablets 

60

Pellets 

Innovative technologies for manufacturing of multiparticulate 

systems with a high drug content (retard 

systems) 

Layered pellets/Matrix pellets 

Fluid bed: Wurster and Ventilus technology 

Different extrusion technologies 

Explosion protection 

Scale-up from 5 kg to 800 kg 

Strong know-how to support our customers 

Technology center solids: 

site with many different pellet technology equipment 

61

Advantages of Pellets 

Gastric residence time is shorter and more predictable 

Reduced variability in release profiles and no risk of dose-dumping 

More flexibility: pellets composed of different, potentially incompatible compounds or 

tailored release profiles can be combined 

Variety of finished dosage forms possible 

Finished dosage forms: 

two-piece 

capsules 

stick packs/ 

sachets 

sustained release 

tablets/MUPS 

Acino reference products: Hydromorphone Artequin paediatric 

Metoprolol, Oxycodone 

62

Pellet Projects 

High volume project with an originator company 

Optimization of the pellet shape 

Improvement of the hardness 

Better filling performance and flowability 

63

Microtablets / Minitablets 

Innovative technologies for manufacturing of multiparticulate systems with a high 

drug content (retard systems) 

Excellent addition to our pellet technology 

Exact dosage formulation 

Easy to handle and countable per unit 

Exact mixing of different substances without 

interfering each other 

High speed filling processes for capsules or 

stick packs 

Strong know-how to support our customers 

64

Granulates 

Hot melt granulation 

Special retard granules with 

melting and additional shock 

freezing treatment 

Organic and aqueous granulation and film coating 

Options for special conditions in production subareas 

Recovery of organic solvents 

Mesalazin - a product with a partner who uses micro 

granules 

Dry coating 

65

Patches 

Broad experience in matrix patches 

Production site with capacity of >100 million 

patches/year 

Coating methods for watery and organic 

solutions 

Kiss-cut and rotary punching 

Vast expertise in controlled substances 

66

Manufacturing Process 

67

Project FC Patch with Bayer 

Hormonal contraception: once-a-week, 21-day regimen patch 

Small, round and transparent 

Investment of around EUR 20 million 

New production facility ready for production in December 2012 

Perfect fit of formulation know-how 

and substance know-how 

Bayer has submitted application for 

MAA in EU 

Bayer expects peak sales of 

EUR 250-500 million 

68

Implants 

Implant manufacturing capacities 

> 200 000 units/year 

Two separate production lines 

Further space available for extension 

Very modern production area 

4 

1 2 

5 

1 Weighing 4 Extrusion 

2 Kryomilling 5 Cutting – Syringe Filling 

3 Mixing 6 Pouching – Sealing 

3 

6 

70

Opportunities 

1. New technologies 

2 projects in evaluation phase 

Good fit to our niche technology focus 

International partners involved 

2. Increasing existing equipment portfolio 

Stick Pack line: Filling tool for 3 different bulks into one stick 

3. Update production sites to US Standard 

One project in the evaluation phase 

71

Opportunity: High Quality Service 

Sourcing 

APIs, 

excipients, 

packaging 

materials 

worldwide 

network 

ensuring 

- competitive 

costs 

- compliance 

= Core Competencies 

* = Supporting services (optional) 

Development 

Feasibility, 

pharmaceutical 

Development 

(CMC elements) 

Formulation/ 

Process 

development, 

Analytics, 

Stability-Testing, 

Scale-up, 

Validation, 

Pilot and clinical 

trial batches, 

Bioequivalence 

Studies* 

Registration Manufacturing 

Drug 

regulatory 

support 

Compilation 

of dossier 

(Module 2,3 

in e-CTD 

format) for 

submissions 

worldwide 

Commercial 

Manufacturing 

and Packaging 

of Finished 

Dosage Forms 

Contract 

Manufacturing 

according to EU- 

GMP 

Marketing* 

Branding/ 

positioning 

support 

Added value 

via trademarks 

72

Opportunity: High Quality Service 

Development Scale-up Technical operations 

Feasibility studies 

Lab scale formulation 

development, typical 

scale: 0.2 – 2 kg 

Formulation 

optimization 

Process development, 

typically 10 – 20 kg 

Pilot scale process 

optimization 

Preliminary process 

validation 

Commercial scale 

verification batches, 

typically >100 kg 

Process validation 

batches 

73

Summary 

Focus on niche technologies 

Very well equipped 

Difficult-to-make expertise 

Strong know-how 

Swiss high quality standards 

74

Competitive factor: Differentiation 

Niche technologies 

– Process know-how (expert) 

– Low competitor environment 

– Special equipment portfolio 

– Innovation potential 

– Concentration on core skills 

– Broad equipment park 

75

Competitive advantage factor: 

HighTech IT-Systems 

Continuous production 

workflow management: 

Improved processes 

Faster and secure data 

entry with SAP interface 

Online process monitoring 

Optimized release of the 

batch records 

Electronic batch records 

SAP Backbone system 

MES system LIMS system TRACKWISE® system 

Laboratory Information and 

Management System: 

Fast/comprehensive 

analytical workflowmanagement 

to support 

QC-activities 

Integration of external contract 

labs into LIMS 

Compilation of 

specifications & methods 

System to track, manage and 

report QA-issues and actions: 

Automated workflows for 

fundamental QAprocesses 

Reduced lead time by 

control of workflow via 

email 

Quick compilation of data 

and customized reports 

76

Competitive advantage factor: OPEX 

Strong focus on shop floor optimization 

Involvement of as much as possible basic staff where suitable 

Visualization of results and progress 

Train-the-trainer concept 

SixSigma, lean management, continuous improvement 

Team concept 

77

Micro Error Tracking System (METS) 

78

Example of 

Applied Error Management with METS 

Efficency monitoring in the packaging division 

Sequence of production orders at the packaging line „Nachtigall“ 

► Dark bars = realized 

packaging efficiency 

(packages/minute) 

► Light bars = lost 

efficiency by errors 

► Colored lines = 

deviation from 

expected efficiency 

79

Strategy to cope with declining 

margins due to price pressure 

Roll-out of OPEX activities (Operational Excellence) to all sites 

Roll-out of MES systems in Germany; first module «weighing system» already 

started (increase degree of automation level) 

Roll-out of LIMS (increase degree of automation level) 

Active acquisition – technology marketing 

Optimization of structures, e.g. by possible reduction of overhead cost 

Savings through centralized purchasing 

General cost reduction through process optimization 

80


Thank you for your 

attention! 

81

Financials 

Robert Schmid, Head of IR, Acino Group 


Aesch 



Phone +41 61 338 60 00 | Fax +41 61 338 60 80

H1-2012 key financials 

(in EUR million) H1-2012 H1-2011 Change 

Revenue 128.9 65.2 98% 

EBITDA 

% of revenue 

EBITDA comparable (1) 

% of revenue 

EBIT 

% of revenue 

EBIT comparable (1) 

% of revenue 

Net profit 

EPS (diluted) 

Net profit comparable (1) 

EPS (diluted) 

Cash flow from operations 

% of revenue 

16.8 

13.0% 

23.4 

18.2% 

3.4 

2.6% 

10.0 

7.8% 

3.1 

0.90 

9.4 

2.79 

(1.6) 

(1.3%) 

11.7 

18.0% 

11.7 

18.0% 

2.8 

4.3% 

2.8 

4.3% 

2.4 

0.76 

2.4 

0.76 

5.3 

8.2% 

Equity ratio in % as of June 30 54% 78% 

(1) Without acquisition related one time items 

43% 

99% 

20% 

257% 

27% 

293% 

-70% 

83

Promising potential areas of 

synergies through integration 

2013 2014 

Basle HQ and R&D activities will be moved to Aesch by end 2012 

Mepha main warehouse activities transferred to Acino premises by 

January 2013 

Combined technical operations structures 

New R&D structure (including regulatory) established 

Engineering (rollout internal engineering, reduction 

external services) 

Finance, HR and IT systems 

Cont. 

Potential 

synergies p.a. in 

EUR million 

Synchronisation of market intelligence 0.5 

1.0 

0.8 

2.6 

1.0 

0.6 

3.5 

Total 10.0 

84

Syndication financing terms 

Facility: 

- EUR 110 million 

Maturity: 

- 5 years 

- amortizing min. EUR 10 million p.a. starting 2013, remaining amount until 2017 

Interest rate 

- EURIBOR + margin dependent to net debt / EBITDA ratio 

- All in cost : currently below 3% p.a. 

Employed per November 30, 2012: EUR 100 million 

Financial Summary: (in EUR millions) 2012 2013 2014 

P&L charge (est.) 2.5 (*) 2.9 2.6 

EPS impact (EUR) 0.74 0.85 0.77 

(*) without one time charges 

85

Reduced currency exposure 

Mepha / Cephalon acquisition leads to reduced FX exposure 

- Sales in CHF: FY 2011 nearly 0%, H1-2012 increase to 15% 

- Sales in USD or related currencies: FY 2011 0%, H1-2012 24% 

- Operating Expenses in USD or related currencies: 

FY 2011 0%, H1-2012 27% 

Amended natural hedge 

86


Thank you for 


87

Summary and strategy 

Peter Burema, CEO Acino Group 


Aesch 



Phone +41 61 338 60 00 | Fax +41 61 338 60 80

Acino’s Business Strategy 

BtB - Outlicensing 



Phone +41 61 338 60 00 | Fax +41 61 338 60 80 

Accelerate growth 

Acquisitory growth through targeted M&A activities 

Organic growth initiatives based on existing opportunities 

BtC - Acino Own 

Brand Marketing 

Technology Marketing

Acino’s growth drivers 

Fully exploit product 

potential 

Expand global reach 

Broaden the product 

portfolio 

Customer base 

expansion 

Acquisitory growth 

Across all businesses 

External impulses 

BtC BtB Technology mktg 

Roll out BtB products in 

the existing BtC markets 


(e.g. CIS) 

Strong development pipeline 

(tailored to both BtC and BtB markets) 

Inlicensing products 

Targeted M&A activities 

Exploit potential of BtC 

products in BtB markets 


(e.g. USA, Japan) 

Start co-developments 

projects (non-exclusive) 

Broaden customer base, 

new acquisition 

Lead project (Bayer) 

nearing market readiness 

Other customer projects 

under way (exclusive) 

New customer acquisition 

based on technological 

strengths 

Operational excellence: high investments, exploit synergies & untapped potential 

Population / GDP growth in 

emerging markets 

Numerous patent expires Market values product 

differentiating features 

90

Geographic break-down of revenue 

Main countries 2010 

(Product sales in end user markets, Acino actuals) (Product sales in end user markets, Acino actuals) 



Phone +41 61 338 60 00 | Fax +41 61 338 60 80 

Main countries H1-2012

Geographic break-down of revenue 

DE 

27% 

CH 

7% 


Main countries estim. 2012 

Others 

4% 

Rest of Europe 

23% 

Africa 

8% 

Asia 

2% LATAM 

4% 

MENA 

25% 


Phone +41 61 338 60 00 | Fax +41 61 338 60 80 

DE 

24% 

CH 

7% 

Rest of Europe 

21% 

Main countries estim. 2013 

Others 

4% 

Africa 

8% 

Asia 

2% LATAM 

4% 

MENA 

30%

Key Facts: Acino TODAY 

Fourth largest listed Swiss pharmaceutical company 

(Acino Holding Ltd., domiciled in Basle, listed at the SIX Swiss Exchange: ACIN) 

7 sites worldwide: 4x Switzerland (Basle, 2x Aesch, Liesberg), 1x Miesbach 

(DE), 1x Paris (FR), 1x Panama (LATAM) 

About 850 employees from over 40 nations 

46 products for own brand marketing in various international territories 

Marketing partnerships in over 130 countries 

– Own brand marketing in over 80 countries (~380 marketing & sales staff) 

– BtB/Outlicensing in more than 50 additional countries 

93


Thank you for 


94

Acino ? Delivering Health

Create successful ePaper yourself

Delete template?

Save as template?