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ACS Dobfar Group Company Presentation Consolidated Financial Statements 31/12/2013

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Page 1: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

ACS Dobfar Group

Company PresentationConsolidated Financial Statements 31/12/2013

Page 2: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

MISSIONTo enable and offer our stakeholders

with cutting edge anti-infective products

by providing the required research,

development and manufacturing services

in a timely and cost-effective way,

leveraging technology and innovative solutions

Page 3: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Fully Integrated Supply of APIs and FDFs

Privately held Italian company

Leader in cephalosporins and carbapenems, strong position in sterile penicillins

Partner of choice for innovative companies with service offerings spanning the entire value chain

Yearly Consolidated turnover of approximately 449M EUR with consistent track record of profitable business

Over 1600 employees worldwide

8 API plants with the production of more than 1000 tons finished APIs out of which 42% account for sterile products

5 FDF facilities manufacturing oral and parenteral dosage forms

Page 4: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Advanced Intermediates &Active Pharmaceutical Ingredients

COMPANY OVERVIEW

Generic sales to third parties

CephalosporinsPenicillins

CarbapenemsOther non-betalactams anti-infectives

Custom pharmaceutical services for innovators

Page 5: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Finished Dosage Forms

Generic sales to third parties

Dry powder vialsSingle and multidose bags

Infusion bagsCapsules

Tablets non-coated, coated and modified release

Oral suspensions

Custom pharmaceutical services for innovators

Contract manufacturing

COMPANY OVERVIEW

Page 6: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

MILESTONES

2003 Sterile Cephalosporins Cosmopolis, Brazil Acquisition of former Eli Lilly facility and foundation of ABL

2001 Sterile Cephalosporins ACSD8_Sesto Ulteriano Italy Acquisition of facility

1996 Fermentation processes ACSD6_Anagni, Italy Acquisition of former N.Nordisk / BMS facility

1995 Non betalactam APIs & Carbapenem APIs

ACSD5_Albano S. Alessandro Italy Acquisition of facility

1990 Intermediates ACSD3_Tribiano, Italy Acquisition of facility

1984 Sterile Cephalosporins & Carbapenems ACSD2_Tribiano, Italy Construction of facility

1980 Sterile penicillins ACSD1_Tribiano, Italy Foundation of plant

1973 Non-sterile Cephalosporins ACSD4_Vimercate, Italy Foundation of plant

Active Pharmaceutical Ingredients

Page 7: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

MILESTONESFinished Dosage Forms

2013 Acquisition of second ABL facility(former Medley) Sumare, Brazil Injectable Cephalosporins

2011 Acquisition of Beker Embu, Brazil Hospital Injectables

2003 Acquisition of former Eli Lilly facility and foundation of ABL Cosmopolis, Brazil Oral and Injectable

Cephalosporins, other injectables

2000 Acquisition of Facta Farmaceutici plants

Pomezia and Teramo, Italy

Injectables and Oral Cephalosporins

Page 8: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Active Pharmaceutical Ingredients

COMPANY STRUCTURE

ABLBrazil

Finished Dosage Forms

Beker Produtos Farmaco Hospitalares

Brazil

Facta Farmaceutici Italy

ACS Dobfar SpAItaly

Page 9: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

ACS DOBFAR, Tribiano (Milan), Italy – 3 facilities ACS DOBFAR, Vimercate (Milan), Italy ACS DOBFAR, Sesto Ulteriano (Milan), Italy ACS DOBFAR, Anagni (Rome), Italy ACS DOBFAR, Albano S. Alessandro (Bergamo), Italy ABL, Cosmopolis, Brazil

Cosmopolis,Embu,Sumare, BRAZIL

Tribiano, Vimercate, Sesto Ulteriano, Albano S.Alessandro, Anagni,TeramoPomezia

ITALY

FACTA FARMACEUTICI, Teramo, Italy FACTA FARMACEUTICI, Pomezia, Italy ABL, Cosmopolis, Brazil ABL, Sumare, Brazil BEKER PRODUTOS FARMACO HOSPITALARES, Embu, Brazil

8 API facilities in 3 continents: 5 FDF facilities in 4 continents:

GLOBAL MANUFACTURING

Page 10: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Raw Material & Intermediate 17%

API Oral 29%

API Sterile 42%

Final Dosage Oral 1%

Final Dosage Sterile 10%

Others 1%

SALES ACS Dobfar is present in

worldwide market supplyingAPIs and FDFs to over 90 countries

Focus on North America, Europe and emerging markets, also through acquisitions, results in growth rate outpacing average dynamics in the generic industry

35%

13%

49%

3%Net Consolidated Sales by Destination

Europa Asia America Africa e Oceania

Page 11: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

During last 7 years sales dynamics exceeded 65% reaching 449M EUR in 2013

NET CONSOLIDATED SALES DYNAMIC

273

449

2006

65%

2013

Serie

smEUR

SALES

Page 12: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

LOCATIONACSD1

Tribiano(Milan, Italy)

ACSD2Tribiano

(Milan, Italy)

ACSD3Tribiano

(Milan, Italy)

ACSD4Vimercate

(Milan, Italy)

ACSD5Albano

S.Alessandro(Bergamo, Italy)

ACSD6Anagni

(Rome, Italy)

ACSD8Sesto Ulteriano

(Milan, Italy)

Cosmopolis(San Paolo, Brazil)

MAIN PRODUCTS

APIs sterile penicillins

Intermediates and APIs sterile

cephalosporins &carbapenems

IntermediatesIntermediates and APIs non-sterile cephalosporins

Non-beta-lactam APIs &

Carbapenem APIsLipopeptide APIs APIs sterile

cephalosporinsAPIs sterile

cephalosporins

TECHNOLOGY Sterile manufacturing

Chemicalsynthesis

Sterile manufacturing

Chemicalsynthesis

ChemicalsynthesisEnzymatic synthesis

Chemical synthesis Enzymatic synthesis

Fermentation

Sterile manufacturing

Chemical synthesis

Sterile manufacturing

APPROVALSLATEST

INSPECTIONS

AIFA April 2014FDA July 2013

AIFA Feb 2013FDA July 2013ANVISA June 2013

- AIFA Jul 2013FDA Dec 2010

AIFA Dec 2012FDA Mar 2014

AIFA Apr 2014FDA Nov 2012 AIFA Feb 2014

FDA Feb 2013MHRA Set 2008TGA Feb 2012ZAB Mar 2014

UNI-EN-ISO14001 Lastcertification

July 2013 April 2014 May 2013 Nov 2012 July 2012 July 2012 Dec 2013

A C S D O B F A R ABL

MANUFACTURING PLATFORM APIs

Page 13: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

MANUFACTURING PLATFORM FDFs

FACTA FARMACEUTICI ABL ABL BEKER

LOCATION Teramo(Rome, Italy)

Pomezia(Rome, Italy)

Cosmopolis (San Paolo, Brazil)

Sumare(San Paolo, Brazil)

Embu(San Paolo, Brazil)

PRODUCTS Injectable cephalosporinscarbapenems Oral cephalosporins

Injectable and oral Cephalosporins

Other injectablessecondary packaging

Injectables glycopeptides

Injectable cephalosporins Secondary packaging Injectable hospital products,

mostly not anti-infectives

DOSAGE FORMS Dry powder fill vials 10-100ml

Capsulestablets (MR, non-coated

and coated)suspensions

CapsulesTablets

SuspensionsVials

Vials Infusion bags 50-500ml

APPROVALS /LATEST

INSPECTIONS

AIFA March 2012ANVISA July 2013

FDA May 2014Only Carbapenems:

GCC March 2014Only Cephalosporins:

Turkish MOH April 2013Taiwan TFDA July 2013

AIFA Nov 2013

MINSAN Feb 2014

FDA Feb 2013MHRA Set 2008TGA Feb 2012ZAB Mar 2014

Anvisa pending ANVISA 2008

Page 14: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

CEFALEXINCEFRADINECEFACLORCEFADROXILCEFIXIMECEFPROZILCEFDINIR

STER

ILE

CEFEPIMECEFOTETANCEFOTAXIMECEFUROXIMECEFTAZIDIMECEFTRIAXONECEFAZOLINCEFOPERAZONECEFAMANDOLECEFOXITINCEFALOTHINCEFTIOFURCEFOTIAMCEFAPIRINCEFQUINOMECEFTAROLINE

NO

N-S

TERI

LEAPIs FDFs

WORLDWIDE LEADER STERILE CEPHALOSPORINS

ACSD 4 / Italy

ACSD 2/ Italy

ACSD 8 / Italy

ABL / Brazil

FACTA Pomezia / Italy

ABL / Brazil

FACTA Teramo / Italy

ABL / Brazil

Page 15: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

FLUCLOXACILLINPIPERACILLINAMPICILLIN SODIUMAMPICILLIN TRIHYDATEPENICILLIN GAMPICILLIN+SULBACTAMNAFCILLINCLOXACILLIN SODIUMCLOXACILLIN BENZATHINE

APIs FDFs

STRONG GOBAL PRESENCE IN STERILE PENICILLINS

ACSD 1 / Italy Contract manufacturer inspected by FDA in 2014 and by AIFA in 2014

Page 16: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

IMIPENEM+CILASTATINMEROPENEM DORIPENEM* PANIPENEM*FAROPENEM* (penem)ERTAPENEM*BIAPENEM*

*Under development, dependent on a patent expiration

APIs FDFs

LEADER IN CARBAPENEMS IN REGULATED MARKETS

ACSD 2 / Italy FACTA Teramo / Italy

Page 17: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

AMIKACINAMPHOTERICIN BCILASTATINCLINDAMYCINDAPTOMYCINGENTAMYCINVANCOMYCIN

APIs

OTHER NON BETA-LACTAM ANTIBIOTICS

ACSD 5 /Italy

ACSD 6 / ItalyABL / Brazil

CLARITOMYCINTEICOPLANIN TOBRAMINVANCOMYCIN

FDFs

Page 18: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Infusional Bags

OTHER PRODUCTS TO COMPLETE HOSPITAL PORTFOLIO

ANTIBIOTICS:CIPROFLOXACIN infLEVOFLOXACIN inf (*)LINEZOLID inf (**)

OTHER ANTI INFECTIVES:METRONIDAZOLE inf ( *) FLUCONAZOLE inf (*)

OTHER PRODUCTS:WATER FOR INJECTIONPERITONEAL DIALISYS SOLUTIONDEXTROSE 5%; 10%; infDEXTROSE 5% + 0,9% SODIUM CHLORIDE MANNITOL 20% infRINGER LACTATE infSODIUM CHLORIDE 0,9 % infPARACETAMOL inf (*)

*= under development**= ANVISA approval pending

Page 19: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

PATENTED PACKAGING SYSTEM FOR STERILE & NON-STERILE APIs

Sterbag is a patented packaging system for Sterile APIs.Product is filled into polyethylene bags (LDPE and HDPE), sealed under vacuum and protected by a third bag containing aluminum. The aluminum bag is sealed under vacuum too, protecting the product from light and water.Sterbag grants high stability of the product, saving space and disposal.The integrity of the package can be easily detected checking for the “brick-like”  shape.

Page 20: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Dry powder fill vials Infusion bags Ampoules

Monodose systems FillChoise ® is used as mixing and drug infusion device, therefore it is not only a container, but a withdrawal and mixing system

System benefits: Its main feature is the absence of needles connecting the components. The system is a close circuit. It does not require the multiple punching of caps, thus eliminates the risk of particle contamination and prevents the nurse from any sensibilisation.

PATENTED INIECTABLE DELIVERY SYSTEM

Page 21: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Multidose systems SmartPak ® is a Drug Delivery & Packaging System designed to simplify thereconstitution of antibiotics in the Hospital Pharmacy Compounding Center

Available for Cephalosporins: CefazolinCefalothinCefuroximeCeftriaxoneCeftazidimeCefotaximeVancomycin

System benefits: Dramatically reduces potential for

medication errors Traceability. No glass means no breakage. Complete safety for the operators. Few operative steps. Reduction of contamination risks. A totally closed system. Maximum sterility. Less material wastage. Costs reduction.

PATENTED INIECTABLE DELIVERY SYSTEM

Page 22: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Net sales growth: 8-10% annually reaching 500M EUR by 2014

Portfolio:

Keep the leading position in cephalosporins

Further develop carbapenems

Further develop ready-to-use bags

BUSINESS ASPIRATIONMain Targets:

New acquisitions: ABL second facility fully operating starting from October 2014

Page 23: ACS Dobfar Group Company Presentation - PharmaCompass · 2000 Acquisition of Facta Farmaceutici plants Pomezia and Teramo, ... ACS Dobfar is present in worldwide market supplying

Thank you