Concord2010 Presentation ENG March 010€¦ · Overview Strategy & Approach Oncology: Pipeline...
Transcript of 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®
Alzheimer’sDisease
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
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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%
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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 ®
756 treated patients
Relapsed/refractory T-cell lymphoma
Combination studies
Relapsed/refractorymultiple myeloma
Mielofibrosis
Elysia rufescens
Irvalec ®
100 treated patients
Lung
Combinationstudies
Oncology:Pipeline
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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 ®
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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
Alzheimer’sDisease
PRECLINICAL DEVELOPMENT REGULATORYTOXICOLOGY
CLINICAL DEVELOPMENT
a b
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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.
Alzheimer’sDisease
NYPTA®:Transgenic Mice
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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*
Alzheimer’sDisease
*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%
Corporate Overview
Strategy & Approach
Oncology:Pipeline
Oncology:Yondelis®
Alzheimer’sDisease
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®
Alzheimer’sDisease
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%