concord2010 presentation eng march 010€¦ · overview strategy & approach oncology: pipeline...

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®

Alzheimer’sDisease

FinancialOverview

1

CONCORD 2010: Presentation4 March 2010

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

2

Disclaimer

“This document includes only summary information and does not intend to be comprehensive. Facts, figures and opinions contained herein, other than historical, are "forward-looking statements" and are based on Management’s current expectations. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the success of the Company’s research strategy; the applicability of discoveries made therein; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing and results of preclinical studies; delayed achievements of milestones; reliance on collaborators; uncertainty as to whether the Company’s potential products will succeed in entering human clinical trials and uncertainty as to the results of such trials; uncertainty as to whether adequate reimbursement for these products will exist from the government, private healthcare insurers and third-party payers; and the uncertainties as to the extent of future government regulation of the pharmaceutical business. Therefore those statements involve risks and uncertainties beyond the Company's control and actual results may differ materially from those stated by such forward-looking statements. The Company expressly disclaims any obligation to review or update any forward-looking statements, targets or estimates contained in this document to reflect any change in the assumptions, events or circumstances on which such forward-looking statements are based unless so required by applicable law.”

Corporate Overview

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

4

Founded: 1939

Listed: 1963

Ticker: ZEL SM

Market Cap* (€): 890.22ml

History of Delivering Commercial Success

� Founded in Spain in 1939 and listed in 1963.

� Holding company with core business in biotechnology.

� Biotech focus: developing marine derived anti-cancer drugs and CNS pathologies treatments.

� Other activities include developing diagnostics kits; RNAi technology based therapeutical applications and consumer chemicals.

* As of February, 19th 2010

Corporate Overview

Biotechnology Consumer Chemicals

100% 100%57.6% 100% 100%100%

Strategy & Approach

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

6

Adopting a Unique Approach to Creating Commercial V alue

Strategy & Approach

“Nature distributed medicine everywhere”.Pliny the Elder -A.D. 77

� The Sea:– Great source of biological material for drug discovery and

development

– Zeltia’s library includes 85,000 marine samples

– PharmaMar: World leader in development of marine anticancer compounds

� R&D Investment:– Focused on improving the treatment of unmet medical needs

using a unique approach:– Novel Mechanisms of Action– Important team specialized in chemical synthesis to reproduce

marine natural compounds

� Business Model:– Integrated business model includes all steps of the discovery

& development process

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

7

Our Human Resources commitments

� To hire Highly-qualified people– Over 72% of the Biotech’s employees are PhDs

and graduates

� To increase employment– Our total work force has increased by 4% in 2009

– Over 85% of the Group’s employees have indefinite contracts.

– Group employs a large proportion of women, including at executive level.

52% 48%% of men in totalwork force

% of women intotal work force

36%64%

Zeltia’s Total work force(by gender aspects)

Zeltia’s Biotech work force(by gender aspects)

51%

21%

28% % Graduates

% PhDs

% Non-graduates

Strategy & Approach

Zeltia’s Biotech work force(by academic background)

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

8

Success Story: Yondelis

� Marketing Authorisations for STS in other countries *: South Korea, Macau, Russia, Argentina, Switzerland, Mexico, Chile, Uruguay, Singapore, Colombia, Vietnam, India Philippines, Bolivia, Paraguay, Thailand, Curaçao, Malaysia, Azerbaijan and Kazakhstan.

� Marketing Authorisations for O.C in other countries *: Philippines and Kazakhstan.

� EU Marketing Authorisation for 2 indications : STS and Ovarian cancer

Our approach has proven successful: YONDELIS®New marine derived chemical entity with a novel Mechanism of Action

*As of February 28, 2010

Strategy & Approach

Oncology: Yondelis ® & Pipeline

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

10

Pipeline Yondelis®

Ecteinascidia turbinata

Yondelis ®

12.000 treated patients

Soft Tissue Sarcoma (STS) – 2nd/3rd line

Relapsed ovarian cancer (Yondelis+Doxil)- 2nd/3rd line

STS with translocations- 1st line

Patient selection: molecularsignature of sensitivity to Yondelis

Breast

Prostate

Paediatrics

RegulatoryPhase III MarketPhase I Phase II

Oncology:Pipeline

� Main Medical Affaires projects:

• Phase II: Yondelis® + Doxorubicin vs. Doxorubicin in 1st Line for STS (ongoing)

• Phase II multicenter: Yondelis® + Doxorubicin in 1st Line for Metastatic Leiomyosarcoma (Uterine or soft tissue) and or Inoperable Relapse (to start soon)

• Phase III multicenter randomized: Yondelis® + Pegylated Liposomal Doxorubicin (PLD) vs. Carboplatin + PLD in Relapsed Ovarian Cancer progressing within 6-12 months (to start soon)

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

11

Strong Oncology Pipeline

RegulatoryPhase III MarketPhase I Phase II

PM-118310 treated patients

Solidtumours

Jorunna funebris

Zalypsis ®

146 treated patients

CervixEndometrial

Solidtumours

Aplidium albicans

Aplidin ®


Relapsed/refractory T-cell lymphoma

Combination studies

Relapsed/refractorymultiple myeloma

Mielofibrosis

Elysia rufescens

Irvalec ®


Lung

Combinationstudies

Oncology:Pipeline

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

12

Forthcoming p ivotal trials:Aplidin ®

• Phase II/III pivotal trial in refractory Multiple M yeloma: 2Q010− 3rd line, in combination with DEXAMETHASONE vs. DEXAMETHASONE− 250 patients− International study− 60 hospitals and 20 countries

• Potential phase II/III pivotal trial in Myelofibros is: 2010− Orphan indication− International study

• Potential phase II/III pivotal trial in refractory T Cell Lymphoma: 2010− 2nd line, in combination with GEMCITABINE vs. GEMCITABINE− International study

Oncology:Pipeline

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

13

Yondelis ®: Commercially Driven Licensing Agreements

� 2001:– Licensing agreement initiated with CENTOCOR ORTHO BIOTECH, subsidiary of

Johnson & Johnson's

� 2009:– Licensing agreement initiated with TAIHO PHARMACEUTICAL for development and

commercialization of Yondelis in Japan

– Licensing agreement initiated with MARINOMED (Austria) for analogs of Kahalalide for all indications excepting cancer and CNS – focus on auto-immune diseases

– Licensing agreement initiated with MEDIMETRIKS (USA) for Kahalalide and two of its analogs, for all indications except cancer and CNS – targeting dermatological diseases as psoriasis

Oncology: Yondelis ®

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

14

Greece, Cyprus and Balkan countries

� Sales force: Genesis Pharma

Scandinavia & Eastern Europe

� Sales force: Swedish Orphan International

Yondelis ®: Significant Market Potential Unlocked through Regiona l Specialists

Logistics : Idis International

Western Europe(88% of European market)� Sales force: PharmaMar / Innovex (Quintiles)

Oncology: Yondelis ®

Alzheimer’s Disease and Other Dementias

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

16

Exciting CNS Pipeline Candidates

NP-61 p.o. ββββ-amyloïde modulator

GEO Neuronal Regeneration Spin Chord injuries

Tau

Amyloidose

Neuroprotection

NYPTA® (NP-12) p.o. GSK-3 Inhibitor Alzheimer’s Disease

NYPTA® (NP-12) p.o. o GSK-3 inhibitor (Orphan drug) Progressive Supranuclear Palsy

NPM-05 Family ( α-secretase activators) AD

PHASE I PHASE IIIPHASE II


PRECLINICAL DEVELOPMENT REGULATORYTOXICOLOGY

CLINICAL DEVELOPMENT

a b

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

17

� Oral chronicle treatment with NYPTA®:

– Significantly reduces the amyloide plaques

– Improves spatial memory in transgenic mice

– Reduces neuronal loss in the hippocampus and the entorrinal cortex

NEURONAL lossNEURONAL loss

AMYLOID pathologyAMYLOID pathology

MEMORY deficitsMEMORY deficits

TAU phosphorylationTAU phosphorylation

Administered orally during 3 months, p.o., 200 mg/kg daily; treatment with mice aged of 9 and 12 months.


NYPTA®:Transgenic Mice

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

18

Alzheimer’s: High Sales Estimates for Treatment Capab le of Retarding Neurodegenerative Process

Pipeline of products in Phase II Compared to Nypta®

11

2 2 14

NON SPECIFIC NEUROPROTECTORS

AMILOYDE PLAQUE REDUCTION

NEUROFIBRILAR TANGLES REDUCTION

MECHANISM NON DEFINED

GSK-3 INHIBITOR

Sales of Alzheimer's Drugs in 2008*


*Source : IMS Health; Business Insights. The CNS market outlook to 2014, 2010

Brand Company Generic Class Sales 2008 (m$) +/- (%) M.S.(%)

Aricept Eisai/Pfizer donepezil AChEI 3.543 19,1% 53,5%

Namenda Forest memantine NMDAA 952 15,4% 14,4%

Exelon Novartis rivastigmine AChEI 777 29,4% 11,7%

Reminyl/Razadyne J&J galantamine AChEI 600 0,7% 9,1%

Ebixa Lundbeck memantine NMDAA 382 20,6% 5,8%

Axura Merz memantine NMDAA 158 27,3% 2,4%

Prometax Esteve rivastigmine AChEI 37 17,2% 0,6%

Memac Bracco donepezil AChEI 26 33,3% 0,4%

Eranz Pfizer (Wyeth) donepezil AChEI 14 21,6% 0,2%

N/A J&J galantamine AChEI 12 - 0,2%

Others drugs 125 59,5% 1,9%

Total 6.626 18,8% 100,0%

Financial Overview

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

20

49.70

2

5300

0

51,69

1

57,53

4

64.00

0

2006 2007 2008 2009 2010 E

Focussed on Developing a Strong R&D Programme

R&D Expenditure – Year on Year (Euro ‘000)

Net Revenue by Segment – Year on Year(Euro ‘000)

69.80

074

.149

70.65

3

71.20

0

73.00

0

10.027

33.350

6.900

51.400

117.000

2006 2007 2008 2009 2010 E

Chemicals Biotechnology

FinancialOverview

Increasing R&D expenditure year on year and greater diversification in revenue streams at Group level

Corporate Overview

Strategy & Approach

Oncology:Pipeline

Oncology:Yondelis®


FinancialOverview

21

Sales in Biotechnology: national & international

Diagnostics Kits (CLART®)

Sales in Spain

0

500000

1000000

1500000

2000000

2500000

3000000

3500000

2007 2008 2009

+49%

+51%

0

500000

1000000

1500000

2000000

€

1 2 3

2007 2008 2009

+37%

+47%

International Sales

Oncología (Yondelis ®)

0

5.000.000

10.000.000

15.000.000

20.000.000

25.000.000

30.000.000

35.000.000

40.000.000

2007 2008 2009

Sales in Spain International Sales

FinancialOverview

Sales (Euros)

+444%

+58%

+326%+26%

concord2010 presentation eng march 010€¦ · overview strategy & approach oncology: pipeline...

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