Pres_Semeraro_INSME-UNIDO_2006.ppt

646 views

Published on

Published in: Economy & Finance, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
646
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
9
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • Although many articles in the recent literature bemoan the diminution in submission of novel product license applications, the real problem, in my mind, is the failure to develop therapeutics and vaccines to treat difficult diseases. This of course, in spite of the wealth of information arising from novel technologies
  • Pres_Semeraro_INSME-UNIDO_2006.ppt

    1. 1. Z-CUBE: THE NEXT GENERATION OF LIFE SCIENCES INVESTING “ The link between venture capital and research: synergies and collaboration ” – INSME-UNIDO Rome, november 30, 2006 Claudio Semeraro – CEO Z-Cube srl
    2. 2. Background Themes <ul><ul><li>Drug industry R&D expenditures greatly outpacing US NCE approvals </li></ul></ul><ul><ul><li>Number of New Biotech — Big Pharma Collaborations continuously increases </li></ul></ul><ul><ul><li>Biotech companies start to attract VC capitals at a more advanced development stage than before </li></ul></ul><ul><ul><li>Significant funding and expertise “gaps” exist for early-stage life science companies </li></ul></ul><ul><ul><li>Public capital market thresholds for liquidity in both North America and the EU continue to rise </li></ul></ul><ul><ul><li>These factors demand a unique approach to life sciences investing… </li></ul></ul>
    3. 3. The Primary Problem: failure to develop therapeutics addressing unmet needs <ul><li>High candidate drug failure rate </li></ul><ul><ul><li><20% of drugs entering human testing get approved </li></ul></ul><ul><ul><li>a drug entering phase I in 2000 less likely to reach market than one entering Phase I in 1985 </li></ul></ul><ul><ul><li>~50% of phase 3 studies fail due to lack of efficacy </li></ul></ul>Source: FDA clinical productivity, ACPS Meeting, October 19, 2004 Rosemberg A.
    4. 4. Lengthening Clinical Times Have Increased Total Times for Approval of New Biological Drugs Tufts Outlook 2003
    5. 5. Current scenario: the pharma innovation gap Source: Burrill & Co 2006 The increasing R&D costs and the reduced R&D efficiency increase challenges and opportunities for biotech companies
    6. 6. Opportunities and challenges for biotech companies
    7. 7. Number of New Biotech — Big Pharma Collaborations 1993-2005 69 165 180 228 224 229 373 425 411 384 117 502 517 Source: BioWorld Financial Watch, American Health Consultants, BioCentury, all biotech 0 50 100 150 200 250 300 350 400 450 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
    8. 8. Selected Biotech Partnering in the Last 12 Months <ul><li>Biogen/Protein Design Labs $800M </li></ul><ul><li>Alnylam/Novartis $700M </li></ul><ul><li>Medarex/BMS $530M </li></ul><ul><li>Pfizer/Coley $505M </li></ul><ul><li>Shire/New River $500M </li></ul><ul><li>Plexxikon/Wyeth $372M </li></ul><ul><li>Nastech/Merck $341M </li></ul><ul><li>Avanir/Astra Zeneca $340M </li></ul><ul><li>Cilag/Basilea Pharma $308M </li></ul><ul><li>Pharmasset/Roche $300M </li></ul><ul><li>CancerVax/Serono $278M </li></ul><ul><li>Astex/AstraZeneca $275M </li></ul><ul><li>GSK/Theravance $252M </li></ul><ul><li>Sirna/Allergan $250M </li></ul><ul><li>GenMab/Serono $215M </li></ul><ul><li>Sucampo/Takeda $210M </li></ul><ul><li>Novartis/Avanir $210M </li></ul>Source: Burrill &Co, 2006, all biotech
    9. 9. Selected Biotech M&A in the Last 12 Months <ul><li>Medicis/Inamed $2.8B </li></ul><ul><li>Solvay/Fournier Pharma $2.1B </li></ul><ul><li>Pfizer/Vicuron $1.7B </li></ul><ul><li>Shire/TKT $1.6B </li></ul><ul><li>GSK/ID Biomedical $1.4B </li></ul><ul><li>Meda/Viatris $1.0B </li></ul><ul><li>OSI/Eyetech $0.9B </li></ul><ul><li>Genzyme/BoneCare $0.6B </li></ul><ul><li>Danisco/Genencor $0.6B </li></ul><ul><li>Pfizer/Angiosyn $0.5B </li></ul><ul><li>Protein Design Labs/ESP Pharma $0.5B </li></ul><ul><li>GSK/Corixa $0.4B </li></ul>Source: Burrill &Co, 2006, all biotech
    10. 10. The VC gap… The challenge of early stage financing
    11. 11. <ul><ul><li>In spite of the increase in total biotech VC funding seed investments are down </li></ul></ul>Total Biotech VC Funding Sources for R&D costs: Pharmaceutical R&D Spending: Pharmaceutical Research and Manufacturers of America, PhRNA Annual Membership Survey, 2003. NIH Budget: National Institutes of Health, Office of Budget, History of Congressional Appropriations, 1992-2003, www.nih.gov 2003
    12. 12. Seed investments remain low… … attrition rate in early financing rounds is high with less than 50% of companies progressing to the following round. Attrition in later stages could be influenced by exits Source: DataMonitor, 2006, only lifescience therapeutics
    13. 13. Fewer deals at research stage Source: DataMonitor, 2006, only lifescience therapeutics
    14. 14. The “equity gap” * University Challenge Seed Funds Mainstream VC Tech Specialists Regional VC Angels UCSF* Grants and Matched Equity 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 Funding range £ x 000 Start-up and seed Development capital Growth capital Equity gap Source: Modified from European Biopharmaceutical Review, Spring 2006 Preclinical/clinical development Tech. Platform Hits Leads/Drug candidate
    15. 15. The challenges <ul><ul><li>Biotech companies start attracting VC capitals at a more advanced development stage than before </li></ul></ul><ul><ul><li>Seed investments in early stage companies remain low </li></ul></ul><ul><ul><li>Early stage companies increasingly need industrial know-how to transform academic innovation into a winning industrial project </li></ul></ul><ul><ul><li>Increasing need of industrial management </li></ul></ul><ul><ul><li>Marketable, VC-grade Business Plan </li></ul></ul><ul><ul><li>Significant funding and expertise “gaps” exist for early-stage life science companies </li></ul></ul>
    16. 16. The VC perspective <ul><li>Early stage investing is far from an exact science </li></ul><ul><li>Early-stage companies are often comprised of little more than an entrepreneur with an idea </li></ul><ul><li>Valuations at the “seed stage” are generally driven by factors that by their nature are subjective </li></ul><ul><li>These include: </li></ul><ul><ul><li>appraisals of the CEO and management team </li></ul></ul><ul><ul><li>novelty of the value proposition </li></ul></ul><ul><ul><li>evaluation of intellectual property </li></ul></ul><ul><ul><li>expected time-to-market </li></ul></ul><ul><ul><li>expected path to profitability </li></ul></ul><ul><ul><li>estimated capital needs and burn rate </li></ul></ul><ul><ul><li>syndicate risk </li></ul></ul><ul><li>Source: Understanding Valuation: A Venture Investor’s Perspective </li></ul><ul><ul><li>A. Dana Callow, Jr. Managing General Partner, Boston Millennia Partners </li></ul></ul><ul><ul><li>Michael Larsen, Senior Associate, Life Sciences </li></ul></ul>
    17. 17. Filling the gap… <ul><ul><li>Venture-backed companies need: </li></ul></ul><ul><ul><ul><li>greater degree of R & D and business development expertise than ever before </li></ul></ul></ul><ul><ul><ul><li>easier access to seed financing to progress at a stage attractive for VC capitals </li></ul></ul></ul><ul><ul><li>Z-Cube brings both sets of skills with a pharma company level of competency </li></ul></ul>
    18. 18. Z-Cube: the venture capital arm of Zambon Group <ul><li>Focus : life sciences and biopharmaceuticals </li></ul><ul><li>Main therapeutic areas : respiratory, pain and inflammation, allergy and immunology, anti-infectives </li></ul><ul><li>Business activity </li></ul><ul><ul><li>Corporate venture capital, investing mainly in early stage. </li></ul></ul><ul><ul><ul><li>NewCos to be developed: ~12- 15 </li></ul></ul></ul><ul><ul><li>Expert support </li></ul></ul><ul><ul><ul><li>Strategic Advisory activities for NewCo formation and development </li></ul></ul></ul><ul><ul><ul><li>Strategic partnering for NewCo development </li></ul></ul></ul><ul><ul><ul><li>Leverage from pharma company expertise in different areas </li></ul></ul></ul><ul><li>Location : Bresso (Milan, Italy) </li></ul>
    19. 19. THE POTENTIAL OF YOUR RESEARCH, CUBED…..
    20. 20. Z-Cube srl: An Entreprenurial Corporate Incubator <ul><ul><li>Subsidiary of the Zambon Group focused on identifying and supporting pharma projects with potential to become a NewCo </li></ul></ul><ul><ul><li>Z-Cube provides skilled project coordinators, capital and an extensive network of experts and relationships to prepare a a validated and marketable business plan with maximum financing potential </li></ul></ul><ul><ul><li>Z-Cube adds value via the type and quality of R & D and business support provided </li></ul></ul>
    21. 21. Z-CUBE MANAGEMENT TEAM Z-Cube integrates competencies for NewCo success <ul><li>Zambon Group SpA </li></ul><ul><li>Competitive Intelligence </li></ul><ul><li>Corporate Marketing </li></ul><ul><li>Intellectual Property </li></ul><ul><li>Finance </li></ul><ul><li>Advisor </li></ul><ul><li>Business advisor (US) </li></ul>Inpharzam Medicinal Chemistry and Biology also devoted to service activities for Drug Optimization <ul><li>Scientific Advisory Board </li></ul><ul><li>D. Bellet </li></ul><ul><li>E. De Clercq </li></ul><ul><li>A. Lanzavecchia </li></ul><ul><li>C. Page </li></ul><ul><li>Z. Wiesenfeld-Halllin </li></ul>
    22. 22. Z-Cube: from Application to NewCo yes yes Business Plan Project Coordinator Z-Cube and Zambon Group team 0 1 3 12 Screening Max Time to NewCo (months) Seed investment THREE TWO ONE Application CDA Pre- screening Z-Cube Advisory Board NewCo Investment partners: - Z-Cube - Financial investors Z-CUBE INCUBATION-DILIGENCE ROAD MAP
    23. 23. Realizing a Project’s Potential CAPITAL TO GET UNDERWAY EXPERT SUPPORT GROWTH CAPITAL AND RELATIONSHIP NETWORK
    24. 24. The Z-Cube Process for Start-up Companies <ul><li>Z-CUBE will fund selected projects with a preliminary investment to develop the Business Plan </li></ul>CAPITAL TO GET UNDERWAY EXPERT SUPPORT <ul><li>Each project will be assigned a project coordinator and professional team from Z-Cube/Zambon . This will ensure the development of a validate and marketable business plan with maximum financing potential </li></ul>GROWTH CAPITAL AND RELATIONSHIP NETWORK <ul><li>Z-Cube designed to invest in and syndicate the early financing rounds for the NewCos </li></ul><ul><li>Z-Cube will support the NewCo with growth capital and its relationship network going forward. </li></ul>
    25. 25. Target for incubation start The proponent: <ul><li>Dynamic researchers/team of scientists with a track record of publications in peer reviewed journals </li></ul><ul><li>Strong enterpreneurial attitude and willingness to support a NewCo creation </li></ul><ul><li>OR </li></ul><ul><li>Company recently formed </li></ul>The project: <ul><li>Innovative projects with potential to become a new therapeutic for unmet medical needs with significant commercial potential </li></ul><ul><li>Active molecules identified (lead series) and supported by at least: </li></ul><ul><ul><li>IP filed </li></ul></ul><ul><ul><li>In vitro/in vivo data in relevant models </li></ul></ul>
    26. 26. <ul><ul><li>Company created/consolidated </li></ul></ul><ul><ul><li>Minimal staff on board or committed (at least CEO) </li></ul></ul><ul><ul><li>Business plan finalized and approved </li></ul></ul><ul><ul><li>IP secured </li></ul></ul><ul><ul><li>Lead project no more than 12-18 months from IND </li></ul></ul><ul><ul><li>Pipeline: more than a single product/project </li></ul></ul><ul><li>Z-Cube designed to invest in and syndicate the early financing rounds for the NewCos with other VCs </li></ul><ul><li>The following characteristics are required: </li></ul>Target for NewCo launch at the end of incubation
    27. 27. <ul><li>Executive Summary </li></ul><ul><li>About 1000 projects screened </li></ul><ul><li>8 projects selected for sponsorship (5 in Europe, 3 in U.S.) </li></ul><ul><li>3 companies launched and financed </li></ul><ul><ul><li>Elagen Inc. (Boston, USA): HPV replication inhibitors </li></ul></ul><ul><ul><li>SuppreMol Gmbh (Munich, Germany): soluble Fc receptors </li></ul></ul><ul><ul><li>PharmEste Srl (Ferrara, Italy): TRPV1 antagonists </li></ul></ul><ul><li>and others coming soon… </li></ul>Track record
    28. 28. Z-Cube: Adding value to create business opportunities <ul><li>Experienced industrial team with on average 20 years expertise in all major therapeutic areas </li></ul><ul><li>First class competences in R&D, clinical developement, project management, strategic support for regulatory strategy and market positioning, business development </li></ul><ul><li>Leverage from Zambon Pharma key competences in intellectual property, legal, finance, strategic marketing </li></ul><ul><li>Leverage from DOIT research centre for technical assessments, drug optimization and library testing </li></ul><ul><li>Delivering of a marketable VC-grade Business Plan </li></ul><ul><li>Granting interim management and leading company staffing and financing </li></ul><ul><li>As lead investor, syndicating capitals from third party investors </li></ul>
    29. 29. A unique approach and an efficacious response to the challenging scenario in life science investing Filling the gap… * University Challenge Seed Funds Mainstream VC Z-Cube Regional VC Angels UCSF * Grants and Matched Equity 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 Funding range £ x 000 Start-up and seed Development capital Growth capital Source: Modified from European Biopharmaceutical Review, Spring 2006 Preclinical/clinical development Tech. Platform Hits Leads/Drug candidate

    ×