083295f30f33fdac6a84b0633653ad76.ppt
- Количество слайдов: 102
IPSEN Position and development in the pharmaceutical domain C. d’Avout, D. Fernet, A. Brunel UV I 2 2006 -2007
Safe Harbor This is an independent study performed by students from the Faculté des Sciences Pharmaceutiques de Lille The opinions expressed are our own and not necessarily those of Ipsen
Ipsen in a nutshell C. d’Avout, D. Fernet, A. Brunel
p 1929: Created by Doctor Henri Beaufour in Dreux p French independent laboratory p Eighth pharmaceutical firm in EU p More than 20 products marketed in over 100 countries C. d’Avout, D. Fernet, A. Brunel
p Profile: n Primary care product: Gastroenterology, cardiovasular, cognitive disorders n 3 targeted therapeutic areas: Oncology, endocrinology, neuromuscular disorders p Sales of 861, 7 M€ in 2006 (↑ 6, 8% / 2005) p 4 R&D centers n 169 MЄ (20, 9%)→ R&D in 2005 C. d’Avout, D. Fernet, A. Brunel
Ipsen in current context C. d’Avout, D. Fernet, A. Brunel
Pharmaceutical industry p Had known a very high growth rate p Very profitable in the XX century C. d’Avout, D. Fernet, A. Brunel
p Social security / assurance p High competition p Blockbusters « culture » Longer Development delay p C. d’Avout, D. Fernet, A. Brunel p p Regulation / Generic Negative public opinion
2001: Jean Luc Belingard C. d’Avout, D. Fernet, A. Brunel
Items Regulation, generic Competitive, blockbuster Big pharma high budget Ipsen’s strategy Focus strategy, Life cycle product management Partnership, R&D, International development Financial strategy, stock exchange Performent staff race Human resource, IDEA Negative pharmaceutical industries image Ipsen foundation, Ethic C. d’Avout, D. Fernet, A. Brunel
Items Regulation, generic Competitive, blockbuster Big pharma high budget Performent staff race Negative pharmaceutical industries image C. d’Avout, D. Fernet, A. Brunel Ipsen’s strategy Focus strategy, Life cycle product management Partnership, R&D, International development Financial strategy, stock exchange Human resource, IDEA Ipsen foundation, Ethic
Ipsen faces up to regulation and generic C. d’Avout, D. Fernet, A. Brunel
Ipsen’s strategy Regulation, Generic Focus strategy Life cycle management C. d’Avout, D. Fernet, A. Brunel
Government measures p European governments introduce various measure to public health spending p In France: because of growing sales of reimbursable drugs → agreement with the « Comité Economique des Produits de Santé » p Failing price due both to the goverment measures and market pressures C. d’Avout, D. Fernet, A. Brunel
Impact on the Group p Ipsen → dependent on the setting of prices for medicines → vulnerable to the possible withdrawal of certain products from the list of reimbursable products C. d’Avout, D. Fernet, A. Brunel
Products Domains: n Primary care cash cows Gastroenterology: Smecta®, Forlax® p Cognitives disorders: Tanakan® p Cardio-vascular: Ginkor fort®, Nisisco® p n Targeted therapy star products Oncology: Décapeptyl® p Endocrinology: Somatuline®, Nutropin. Aq®, Testim® p Neuromuscular disorders: Dysport® p C. d’Avout, D. Fernet, A. Brunel
Star product and cash cow turnover STARS PRODUCTS CASH COW Neuromuscular disorders Gastroenterology Endocrinology Cardiovascular Oncology C. d’Avout, D. Fernet, A. Brunel Cognitive disorder Others
Cash cow’s threat: Regulation Tanakan® Active substance: EGb 761® (Ginkgo biloba) antioxidant, neuroprotective, vasoactive properties Indications: q q Age-related cognitive disorders pathophysiological deficiency cochleovestibular disorders retinal deficit C. d’Avout, D. Fernet, A. Brunel
q Marketing: q q q 15 % of sales (2005) France in 1975 → 60 countries (Europe and Asia) Tanakan® R&D: - Phase III → validate the clinical benefits in neuro degenerative disorders (Alzeihmer) 8 000 patients 8 clinical studies currently C. d’Avout, D. Fernet, A. Brunel
Ginkor Fort® q Active substances: q Troxerutin A, heptaminol chlorhydrate, Ginkgo biloba extract q Indications: q q Treatment of vascular conditions, venous insufficiency of the lower limbs, acute haemorrhoid episodes Marketing q 15 % of sales C. d’Avout, D. Fernet, A. Brunel
Tanakan ® New assessment of the medical benefit on February 2006 Recommendation to the Health Ministry C. d’Avout, D. Fernet, A. Brunel Ginkor Fort® 15 % of the price on february 2006 the reimbursement rate to 15% (until december 2007) 1 January 2008: withdrawn from the list of reimbursable drugs
Primary care: Cash cow Smecta® Diosmectine ( natural clay) • Chronic and acuate diarrhoea • Pain associated with gastric, colonic disorders C. d’Avout, D. Fernet, A. Brunel Forlax® Macrogol 4000 (polyethylene glycol polymer) Constipation (2005: paediatric formulation)
1977, France 1996, France 18 % of sales 11 % of sales 70 countries 60 countries Patent expired (1995) No patent field C. d’Avout, D. Fernet, A. Brunel
Cash cow’s threat : Focus strategy→ Star products Life cycle management C. d’Avout, D. Fernet, A. Brunel
Star product: Decapetyl® q p Active substance: Triptorelin (decapeptide, analogue of the natural hormone Gn. RH) Indications: n Prostate cancer n Pterin fibroids n Endometriosis n Early-onset puberty n Female infertility q Marketing: n 26 % of sales n 60 countries (25 in Europe) C. d’Avout, D. Fernet, A. Brunel n Expiration patent date: p Pamoate: 2010 in Europe, USA p Acetate: since 2001 p Partnerschip : p Debiopharm holds patent p R&D : n Phase III : Combined hormone therapy for premenopausal breast cancer n Phase II : New formulation: 4 months
Star product: Nutropin. Aq® q Active substance: liquid formulation of recombinant human growth hormone p p Marketing: n September 2002: Genentech granted Ipsen exclusive marketing rights for Nutropin. Aq® worldwide n Expiration patent: 2013 n Phase III : Extending the indication for the treatment of idiopathic short stature: FDA and EMEA n Phase II : Prevention of the long-term effects of glucocorticoid treatment Indications: treatment of growth failure p R&D : C. d’Avout, D. Fernet, A. Brunel
Live cycle managment Somatuline® and Somatuline autogel® q. Active substance: Lanreotide (somatostatin analogue) Inhibits secretion of growth hormones q. Indications: Acromegaly and neuroendocrine tumours q. Marketing: § 11% of sales § Launched in France in 1995, 50 countries § Partnership : TEIJIN Tokyo (Japan) C. d’Avout, D. Fernet, A. Brunel
Life cycle management of Somatuline® p Product: Somatuline® Somatuline autogel® p Patent: 2005 2015 p Injection: 2 or 3 inj/mth 1 inj/mth p R&D: p Acromegaly (USA) : January 2007 p Somatuline® Autogel® neuroendocrine tumours (USA, Europe) phase III p Development of sustained-release formulations 3 months C. d’Avout, D. Fernet, A. Brunel
n Competitor : Sandostatin® (Novartis) Somatuline® Sandostatin® Indications Acromegaly, NET Administration SC IM Injected volume 0, 4 ml 2, 0 ml Needle length 20 mm 40 mm Ready to use Powder to reconstitute Formulation
Live cycle managment Dysport® p Active substance: botulinum neurotoxin type A complex ( acts at the level of the neuromuscular junction in the targeted muscle) p Indications: § § § q Cervical dystonia Cerebral palsy in children Blepharospasm Marketing: § 12 % of sales C. d’Avout, D. Fernet, A. Brunel
Life cycle management of Dysport® Reloxin® USA n n Aesthetic medicine indications Phase III clinical trials Regulatory submissions with the FDA during 2007 Development and distribution agreement with Medicis R&D → clinical trials on Dysport® n n n Europe: phase III aesthetic medicine indications USA (august 2005): phase III cervical dystonia Phase II myofascial pain C. d’Avout, D. Fernet, A. Brunel
Items Regulation, generic Competitive, blockbuster Big pharma high budget Performent staff race Negative pharmaceutical industries image C. d’Avout, D. Fernet, A. Brunel Ipsen’s strategy Focus strategy, Life cycle product management Partnership, R&D, International development Financial strategy, stock exchange Human resource, IDEA Ipsen foundation, Ethic
Ipsen faces up to high competition C. d’Avout, D. Fernet, A. Brunel
Ipsen’s strategy Competitive, Big pharma companies Partnership International development Critical size Blockbuster culture R&D C. d’Avout, D. Fernet, A. Brunel
Partnership objectives p Ipsen wants to stay independent → necessity to find partners: n n University teams Pharmaceutical and biotechnology companies Additives associations → get the critical size «Collaboration is more efficient than competition !» p C. d’Avout, D. Fernet, A. Brunel
Gain access to cutting-edge technologies in complex areas of expertise Finance development of its products while extending its range of existing products C. d’Avout, D. Fernet, A. Brunel
R&D data p Budget: 20, 9 % of CA (19, 1% in 2004) p 700 people highly qualified p Currently 20 programs C. d’Avout, D. Fernet, A. Brunel
Boston 4 platforms p Peptide engineering n p Modification through synthesis of derivative of naturally occuring neuropeptide hormones Protein engineering n Improve therapeutic properties of naturally occuring proteins through the selective modification of their sequences C. d’Avout, D. Fernet, A. Brunel
Barcelona p Medicinal chemistry: Paris n p Paris Discover enzyme inhibitor, mitochondrial protective agents and non-peptide ligands for specific hormone receptors Advanced drug delivery: Barcelone n Innovative formulations for new or existing products in order to optimise the efficacy of the active substance while improving patient quality of life C. d’Avout, D. Fernet, A. Brunel
R&D and partnership: Extend pipeline C. d’Avout, D. Fernet, A. Brunel
Oncology p New approaches in cancer treatment under hormonal control: n Key enzyme inhibitors in the biosynthesis of steroids n Growth factors n Enzymes regulating cell cycles (notably phosphatases) n Genes implicated in cancer C. d’Avout, D. Fernet, A. Brunel
Drug conception for cancer under hormonal control p Sterix : acquisition (February 2004) p Collaboration (University of Bath and Imperial College London) n p Technological platform in the field of cancer under hormonal control Post menopausal breast cancer expressing oestrogenic receptors n Phase I: STX 64 n Selective inhibitors of the sulphatase enzyme involved in a key stage of the biosynthesis of oestrogens C. d’Avout, D. Fernet, A. Brunel
Genes implication in cancer p May 2003: Spirogen, London (UK), biotechnology company Technological platform: Potential to identify the genes involved in therapeutics such as cancer p Advanced metastasic cancer refractory to chemotherapy (phase I) p Leukaemia resistant to other treatments n BN 2629 (SJG 136), Synthetic molecule p Ability to block the anarchic cellular proliferation process p Cancer Research in the UK and the National Cancer Institute in the USA C. d’Avout, D. Fernet, A. Brunel
Ipsen is looking for partnership to continue the development of topoisomerase’s inhibitor p Lung cancer Diflomotecan n Investigations into others indications (phase II failed) Treatment of certain types of advanced metastatic cancers (colon, breast and prostate) n p n n Elomotecan Phase I clinical trials C. d’Avout, D. Fernet, A. Brunel
Endocrinology p Pituitary disorders (such as acromegaly) n Second-generation somastatin analogues and growth hormone antagonists p Cachexia treatment (peptide hormone) p Metabolic syndrom associated with obese patients with hyperinsulinemia (11βHSD enzyme inhibitors programmes) C. d’Avout, D. Fernet, A. Brunel
GLP 1 p Glycaemia control in diabetic patients n BIM R 1007/GLP 1, phase II n Analogue of peptide hormone Glucagon Like Peptide-1 n Discovered by Ipsen n October 2003: Partnership option for Roche on an exclusive licence to the rights to develop and market worldwide (with the exception of Japan and France) n Sustained-release formulations, phase I clinical trials (with Teijin) C. d’Avout, D. Fernet, A. Brunel
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p Caracteristics n n n p Equal / greater potency compare to native compound Extended metabolic half-life: 22 x more stable in plasma Strong patent positions Roche option: partnership n n n 56 M€ paid upfront 170 M€ potentials additionnal milestones ~ 15% royalties on worldwide net sales C. d’Avout, D. Fernet, A. Brunel
+ : advantages n n n Very big market Patent → 2019 New formulation for 1 month - : competitors n n n Eli Lilly : exenatide already in USA Novo-Nordisk: liraglutide phase III Sanofi-Aventis: phase II C. d’Avout, D. Fernet, A. Brunel
Others domains p COGNITIVE DISORDER n p Neurodegenerative conditions (Alzheimer) HAEMATOLOGY phase II trials in USA n OBI-1: recombinant version of porcine factor VIII n Treatment of congenital or acquired haemophilia resistant to human factor VIII n Partner: Emory University and Octagen C. d’Avout, D. Fernet, A. Brunel
p RHUMATOLOGY p Treatment of symptomatic hyperuricaemia n July 2003: Agreement with Teijin to develop in Europe Febuxostat n 2 october 2006: EMEA approved AMM submission C. d’Avout, D. Fernet, A. Brunel
Other partnerships p INSERM Paris, France, October 2005 n p NOVARTIS Basel, Switzerland, March 2003 n n p Conduct a R&D programme in the treatment of breast and prostate cancer Trademark transfer agreement Distribution agreement in France for Nisis® and Nisisco® (previously marketed and distributed by Sanofi-Aventis) PFIZER New York, USA, November 2005 n Promoting its Artotec® product in France from 1 January 2006 C. d’Avout, D. Fernet, A. Brunel
RADIUS Cambridge, USA, September 2005 n p RECORDATI Milan, Italy, October 2006 n n p Exclusive right for Radius to develop, manufacture and distribute BIM 44058 (as well as its analogues), treatment of osteoporosis Sold the exclusive rights to market and sell Tenstaten® in France to Recordati for 7 years beginning 1 January 2006 Sales: 11. 4 M€ in 2005 FAES Pharma C. d’Avout, D. Fernet, A. Brunel
INTERNATIONAL DEVELOPMENT C. d’Avout, D. Fernet, A. Brunel
Ipsen sites Europe Research centers: France, Spain, England Indistrual sites : France, Swizerland, Ireland, England, Spain Commercial presence : Other European country C. d’Avout, D. Fernet, A. Brunel
Ipsen sites around the world US : research, industrial site and commercial presence South America : commercial presence C. d’Avout, D. Fernet, A. Brunel China : industrial site and commercial presence Rest of Asia : commercial presence
Worldwide Staff 16% Rest of the world 15% Other in UE 69% Five European countries : France, Germany, UK, Spain, Italy C. d’Avout, D. Fernet, A. Brunel
Turnover in the world Good implantation in Europe 14, 3% C. d’Avout, D. Fernet, A. Brunel Need much more implantation in the rest of the world PARTNERSHIPS
Items Regulation, generic Ipsen’s strategy Focus strategy, Life cycle product management Competitive, blockbuster Partnership, R&D, International development Big pharma high budget Financial strategy, stock exchange Performent staff race Human resource, IDEA Negative pharmaceutical industries image Ipsen foundation, Ethic C. d’Avout, D. Fernet, A. Brunel
Ipsen faces up to rich competitors C. d’Avout, D. Fernet, A. Brunel
Ipsen’s strategy Big pharma high budget Financial strategy Stock exchange C. d’Avout, D. Fernet, A. Brunel
p Turnover (2005) : n Ipsen: 807, 1 Millions € n Pfizer: 25, 5 Billions € 31 times smaller than Pfizer C. d’Avout, D. Fernet, A. Brunel
Turnover’s evolution +4, 4% C. d’Avout, D. Fernet, A. Brunel +4, 8% +6, 7%
Medicines’ turnover Decapeptyl Tanakan Dysport Somatuline Smecta Ginkor Fort Forlax Nisis Nisico Nutropinaq 25% part of turn over threated by disrimbursement ! C. d’Avout, D. Fernet, A. Brunel New budget for investment
Prospects -Good forecast of increase -Good support -But: • Threats • ~ Increase forecasted C. d’Avout, D. Fernet, A. Brunel
Financial general strategy November 2005 Launching of stock exchange process December 2005 Introduction 22€ 20 January 2006 C. d’Avout, D. Fernet, A. Brunel Launching of buy backing shares Liquid assets program
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Shareholders p After the IPO, Ipsen’s capital : n 80. 97% owned by Mayroy n 18. 73% by the public n 0. 30% by the employees The part not owned by Mayroy brought : 324 M€ p C. d’Avout, D. Fernet, A. Brunel
Mayroy p Anonym society, Luxembourg Beaufour family p Voting right : double voting if > 2 years in the name of the same shareholder p Shareholders agreement only between shareholders of Mayroy C. d’Avout, D. Fernet, A. Brunel
Stock variation since December 2005 New suspition of disreimboursement - Results Pulication - Tercica partnership Low: 22, 50 € C. d’Avout, D. Fernet, A. Brunel High : 35, 43 € Change : 57, 5 %
Ipsen performance compare to the CAC 40 p Ipsen over performed the market during the entire period
Market Comparative study Comparison between Ipsen and its European competitors q Sector average : All the Pharmaceuticals firms in European Union (30) (Sanofi-Aventis, Bayer Schrg, UCB SA, ALTANA, Schwarz Pharma, Merck KGa. A, Elan, Ipsen, STADA Arzneimitt, Orion, Tubize, Faes, Zentiva, Recordati, Intercell, Stallergenes, Flamel Technol, Boiron SA, Virbac SA, Guerbet SA, Arkopharma, Vetoquinol, Lavipharm SA, Jerini, Fornix Bio. Scnce, Veterin SA, Sanochemia, Octo. Plus, Pierrel Sp. A and Alltracel Pharm) q Direct Competitors : All the Pharmaceuticals companies that are comparable (Zentiva, Faes, Tubize, Orion, STADA Arzneimitt, Ipsen, Elan, Merck KGa. A) C. d’Avout, D. Fernet, A. Brunel
Ipsen stock market performance compare to its sector p Ipsen stock market under performed compare to the sector C. d’Avout, D. Fernet, A. Brunel
Price Earning = market value per share/ Earning per share (The smaller the better) Ipsen Investors have a higher return compare to its competitors as well as compare to the whole sector C. d’Avout, D. Fernet, A. Brunel
Dividend p 2 nd June 2006: Ipsen’s annual Shareholders’ meeting n Distribution of a dividend of 0, 60€ / per share C. d’Avout, D. Fernet, A. Brunel
Dividend Yield in % The Dividend Yield of Ipsen is significantly higher than the sector average as well as its direct competitors C. d’Avout, D. Fernet, A. Brunel
Return on Equity in % ROE = net Return / shareholders equity (the higher, the better) Ratio on profitability that show much profit a company generates with the money shareholders have invested C. d’Avout, D. Fernet, A. Brunel
Liquidity q Maximum 10% of actions authorized q Maximal prize: 50 euros q Time: 18 months q Objective: n n New dynamic on Ipsen market Eventually sell shares later C. d’Avout, D. Fernet, A. Brunel Second growth
Items Regulation, generic Competitive, blockbuster Big pharma high budget Ipsen’s strategy Focus strategy, Life cycle product management Partnership, R&D, International development Financial strategy, stock exchange Performent staff race Human resource, IDEA Negative pharmaceutical industries image Ipsen foundation, Ethic C. d’Avout, D. Fernet, A. Brunel
Ipsen faces up to performent staff race C. d’Avout, D. Fernet, A. Brunel
Ipsen’s strategy Performed staff race Effective management of human resource IDEA C. d’Avout, D. Fernet, A. Brunel
Strategic reorganization n Since 2001, JL Bélingard is in charged to give a new impulsion to Ipsen → new organisation of corporate governance (2005) 4 committees: Strategic (chairman→ JL Bélingard) p Audits p Compensations p Appointments (chairman → Anne Beaufour ) p C. d’Avout, D. Fernet, A. Brunel
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Jean Luc Bélingard p Graduated from the HEC 1971 and MBA (US) in 1974 p In 1982 Roche Group: head of the diagnostics division p From 1999 to 2001, member of executive board of Bio. Mérieux-Pierre Fabre p 2001: Ipsen p Delegate General and spokesman for G 5 (namely Sanofi. Aventis, Servier, Pierre Fabre and Ipsen) p Beginning of 2006: Board of Directors of Inserm C. d’Avout, D. Fernet, A. Brunel
Anne and Henry Beaufour p Anne Beaufour p p Bachelor of geology degree (University of Paris Orsay) Director of the Company since 1998 p Henri Beaufour p p Bachelor of arts degree (Georgetown, University of Washington DC, USA) Director of the Company since 2000 C. d’Avout, D. Fernet, A. Brunel
3800 employees worldwide Administration and support → 14 % Research and development activities → 18, 2% Manufacturing and supply chain function → 27, 9% C. d’Avout, D. Fernet, A. Brunel Sales → 40, 2 %
Recruitment and internal promotion In 2005 : p 746 new employees p Permanent jobs: 576 p 182 employees were promoted p Opportunities: change jobs, switch functions, move to new locations regularly offered C. d’Avout, D. Fernet, A. Brunel
Ipsen and training programme p Number of hours of training 2004: 107 958 +25% p Number of hours of training 2005: 135 143 p During 2 OO 5 IDEA : Ipsen Development and Education Academy p Created in order to facilitate the development of training C. d’Avout, D. Fernet, A. Brunel
IDEA objectives p Six objectives : n Development and advancement of a corporate culture n Integration of new employees n Young professionals college, which aims to Attract and accelerate the development of high-potential of young professionals who will be involved in key roles C. d’Avout, D. Fernet, A. Brunel
n The managers college → raise the performance of managers to a high level n The leaders college → develop the leadership skills in long-term strategic areas n The Group’s image C. d’Avout, D. Fernet, A. Brunel
Items Regulation, generic Competitive, blockbuster Big pharma high budget Ipsen’s strategy Focus strategy, Life cycle product management Partnership, R&D, International development Financial strategy, stock exchange Performent staff race Human resource, IDEA Negative pharmaceutical industries image Ipsen foundation, Ethic C. d’Avout, D. Fernet, A. Brunel
Ipsen faces up to a negative brand image C. d’Avout, D. Fernet, A. Brunel
Ipsen’s strategy Negative companies brand image Ipsen Foundation Ethic C. d’Avout, D. Fernet, A. Brunel
Ipsen’s foundation p Created 1983 in order to n n Improve the knowledge diffusion Develop communication between various actors of pharmaceutical domains p Thousands of researchers and doctors p 60 international congress p 180 Alzheimer actuality revues p 65 publications C. d’Avout, D. Fernet, A. Brunel
Ipsen’s foundation p Awards prizes to scientist for work p Seminars about : n n n Alzheimer disease Neurosciences Vascular tree Endocrinology Longevity C. d’Avout, D. Fernet, A. Brunel
Environment p Ethic: long-time development Production platforms respect the environment n Sensitisation campaign to energy consumption n Significant budget for environment protection n C. d’Avout, D. Fernet, A. Brunel
SWOT analysis C. d’Avout, D. Fernet, A. Brunel
p SWOT analysis : determinate if « strengths and weaknesses association is able to square up environment evolutions » p Opportunities and Threats p Strengths and Weaknesses C. d’Avout, D. Fernet, A. Brunel
Opportunities and threats p Opportunities n n n p Increase of life expectancy needs in medicines New innovated therapy obesity, cancer Opportunities on US market Threats n n Generics and regulation patents and prices Research process longer and more expensive C. d’Avout, D. Fernet, A. Brunel
Strength and Weakness p Strengths n n p New financial prospects Headstaff and good management Research platform very developed Portfolio quite diversified Weaknesses n n R&D budget too high compared to ipsen’s size Too high dependence on Europeen market C. d’Avout, D. Fernet, A. Brunel
Ipsen has to reach a critical size to have R&D expenditures that not bear upon turnover C. d’Avout, D. Fernet, A. Brunel
p CLAIRE : Marketing n n p DOMITILLE : Marketing n p + : GLP-1 - : Cash cow + : Management of cycle life products, IDEA ALBANE : R&D Analysis n n + : Interesting R&D portfolio - : Genetical desease C. d’Avout, D. Fernet, A. Brunel


