Santhera Pharmaceuticals Holding AG · SIX:SANN

Santhera Pharmaceuticals — Shareholder Meeting (April 2009)

17 slides from Santhera Pharmaceuticals's shareholder meeting presentation, Apr 27, 2009

  1. Slide 1: An Emerging Product Company

    An Emerging Product Company Annual Shareholders’ Meeting Basel, April 27, 2009

  2. Slide 2: Strong Operational and Financial Results in 2008

    Strong Operational and Financial Results in 2008 ƒ First product approval moves Santhera from development to product company ƒ Successful launch of Catena® in Canada ƒ Robust pipeline: R&D programs on track ƒ Well financed into 2011 according to current financial planning 2009 Shareholders’ Meeting

  3. Slide 3: Today's Agenda

    Today‘s Agenda 1. Key Achievements 2008 2. Update on Clinical Development Programs 3. Update on Commercial Operations 4. Financial Results 2008 5. Outlook 2009 Shareholders’ Meeting 3

  4. Slide 4: Major Events in 2008: Key Milestones (1)

    Major Events in 2008: Key Milestones (1) ƒ Regulatory – Approval of Catena® for treatment of Friedreich’s Ataxia in Canada – Early approval in EU refused ƒ Marketing & Sales – Successful Canadian launch of Catena® ƒ Clinical – Friedreich’s Ataxia: US (IONIA) and European (MICONOS) Phase III trials f

  5. Slide 5: Major Events in 2008: Key Milestones (2)

    Major Events in 2008: Key Milestones (2) ƒ Preclinical – MC4 receptor antagonist program in Cancer Cachexia reaches late preclinical stage ƒ Operational – North American Marketing & Sales established in Boston and Montréal ƒ Financials – Cash runway secured into 2011 – Capital increase of about CHF

  6. Slide 6: Substantial Progress in Development Portfolio

    Substantial Progress in Development Portfolio Preclinical Phase I Phase II Phase III Filing Market Catena® in Canada Friedreich's Ataxia Sovrima® in Switzerland Friedreich's Ataxia Catena®/Sovrima® in US, EU Friedreich's Ataxia Catena®/Sovrima® Duchenne Muscular Dystrophy Catena® Leber’s Hereditary

  7. Slide 7: Catena in Friedreich's Ataxia: Update on US IONIA Study

    Catena® in Friedreich‘s Ataxia: Update on US IONIA Study 80 70 ƒ 70 ambulatory patients; aged 8 to 17 60 ƒ LPI October 31, 2008 50 ƒ 6 month treatment 40 ƒ LPO April 14, 2009 ƒ 2 dose arms vs placebo 30 ƒ Top-line data in summer 2009 20 ƒ NDA & MAA filings in late 2009 10 0 Apr-08 Nov-08 Apr-09 Aug-

  8. Slide 8: JP-1730/fipamezole in Dyskinesia in Parkinson's Disease: Update on FJORD Study

    JP-1730/fipamezole in Dyskinesia in Parkinson’s Disease: Update on FJORD Study 210 180 ƒ 180 patients recruited ƒ 120 evaluable patients required, 150 about 130 expected ƒ 33 study centers in US and India 120 ƒ 28 days treatment 90 ƒ Top-line data in summer 2009 ƒ Subsequent Santhera decision on 60

  9. Slide 9: Focus on Orphan Neuromuscular Diseases

    Focus on Orphan Neuromuscular Diseases Preclinical Phase I Phase II Phase III Filing Market Catena® in Canada Friedreich's Ataxia Sovrima® in Switzerland Friedreich's Ataxia Catena®/Sovrima® in US, EU Friedreich's Ataxia Catena®/Sovrima® Duchenne Muscular Dystrophy Catena® Leber’s Hereditary Optic N

  10. Slide 10: Fast Market Uptake of Catena in Canada

    Fast Market Uptake of Catena® in Canada 90 80 ƒ 25-40% of patient population have 70 prescription after 7 months ƒ 50:50 split between public and 60 private insurance 50 ƒ 30% of prescriptions for high dose 40 ƒ All major private payors accept Catena® in their formularies 30 ƒ Ongoing negotiations f

  11. Slide 11: Canadian Launch Shows That We Are on the Right Track

    Canadian Launch Shows That We Are on the Right Track ƒ Meeting an unmet medical need translates into high and instant awareness amongst prescribers and patients ƒ Patients are organized in dedicated medical and patient communities ƒ Majority of patients are treated by a small number of specialized c

  12. Slide 12: Financial Information 2008

    Financial Information 2008 Key Financials (IFRS, consolidated, in CHF thousands) 2008 2007 ƒ Transition into product company with Cash and cash equivalents 75,006 106,618 a first marketed product Net increase cash/cash equivalents - 31,612 - 19,044 ƒ Monthly net cash-burn of CHF 2.6m Net sales 48 0

  13. Slide 13: Operating Expenses 2008: Functional Allocation

    Operating Expenses 2008: Functional Allocation ƒ Research & Development: 23% 69% (CHF 31.5m) of total operating expenses (55% in 2007) ƒ Marketing & Sales: 8% 8% (CHF 3.5m) ƒ General & Administration: 69% 23% (CHF 10.6m) R&D M&S G&A ƒ Total operating expenses: CHF 45.6m 2009 Shareholders’ Meeting 13

  14. Slide 14: Financial Information 2008

    Financial Information 2008 Consolidated Balance Sheets (IFRS, condensed, in CHF thousands) December 31 2008 2007 ƒ Fully equity financed ƒ Strong cash position Cash and cash equivalents 75,006 106,618 ‒ Cash reach into 2011 including Noncurrent assets 31,641 34,588 product sales and partnering incom

  15. Slide 15: Share Price Development since IPO (vs. SPI)

    Share Price Development since IPO (vs. SPI – Swiss Performance Index) 29 Nov 07 24 Jul 08 Filing CAN Approval CAN 24 Jul 08 1st negative CHMP 16 Aug 07 9 Nov 08 Filing EU 2nd negative CHMP 31 Jan 07 Intention to file 29 Oct 07 DMD data SPI SANN 10 Oct 08 Launch CAN 6 Nov 08 Ares Life Sciences 2006 2

  16. Slide 16: Expected Milestones and News Flow

    Expected Milestones and News Flow ƒ Top-line data IONIA Phase III trial; Subsequent filing 1H 2009 of NDA & MAA ƒ Swissmedic decision on Sovrima® in Friedreich’s Ataxia 2H 2009 ƒ Top-line data Phase IIb trial with JP-1730/fipamezole in Dyskinesia in Parkinson’s Disease; Potential acquisition of Juva

  17. Slide 17: FY Shareholders’ Results, February

    2009 FY 2008 Shareholders’ Results, February Meeting27, 2009 17

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