A Leader
in Therapeutic Antibodies January 11, 2006 JP Morgan Conference Filed Pursuant to Rule 425 Registration No. 333-130441 January 10, 2006 |
2 NASDAQ: XOMA Statements made in this presentation relating to future financial performance or results,
the timing of regulatory filings, the timing and results of clinical trials
and other aspects of product development, collaborative and other strategic
relationships, the regulatory process and approvals, collaboration and licensing opportunities and plans for sales and marketing, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions which may not prove accurate. Actual results
could differ materially from those anticipated, due to certain risks
inherent in the biotechnology industry, as well as for companies engaged in the development of new products in a regulated market.
These risks, including those related to the success of the sales and marketing
efforts for our products, the size and timing of expenditures, whether there
are unanticipated expenditures and whether funds are available on acceptable
terms; safety or efficacy of the products being tested; design and progress of clinical trials; additional time requirements in connection with regulatory filings for data analysis, filing preparation, discussions with the FDA, additional clinical studies or manufacturing
process modifications; action, inaction or delays by the FDA, European regulators and/or their advisory bodies; analysis and interpretation by, or submission to, these entities and others of scientific data; results of pre-clinical testing; changes in the status of the Company's collaborative and other relationships; the ability of partners to meet their obligations; availability of collaboration and
licensing opportunities; success of competitors; market demand for products;
uncertainties regarding biotechnology patents; uncertainties as to the costs
of protecting intellectual property; and risks associated with XOMA's status
as a Bermuda company are discussed in the Company's most recent report on Form 10-K and in other SEC filings. Such risks should be considered carefully in evaluating XOMA's prospects. Copyright 2006, XOMA Ltd. Forward-Looking Statements |
3 NASDAQ: XOMA XOMA, Ltd. has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents XOMA has filed with the SEC for more complete information about XOMA and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov . Alternatively, XOMA or the information agent will arrange to send you the prospectus if you request it by calling toll-free 1-888-867-6963. |
4 NASDAQ: XOMA Premier Therapeutic Antibody Discovery and Development Company Managing Development and Financial Risks, Effectively Utilizing Assets Marketed Product plus Diverse, Growing Pipeline XOMA Right Place, Right Time, By Design |
5 NASDAQ: XOMA Antibody Technologies Antibody Technologies Comprehensive Antibody Platform for Comprehensive Antibody Platform for Discovery, Optimization and Manufacturing Discovery, Optimization and Manufacturing Multiple Antibody Phage Display Libraries Proprietary Human Engineering ™ Technology Bacterial Cell Expression |
6 NASDAQ: XOMA XOMA Human Engineering Technology Clinically Validated 100% Success Rate To Date 25 mAbs Human Engineered 6 Different Targets Structural Approach Applicable to mAbs from any Species Issued IP Reduce Immunogenicity Reduce Immunogenicity of Non-human mAbs of Non-human mAbs |
7 NASDAQ: XOMA Therapeutic Antibody Development Therapeutic Antibody Development Antibody Lead Discovery Preclinical Development Clinical Development Tech Dev Mfg Fully Integrated Development Infrastructure Fully Integrated Development Infrastructure Target Discovery Functional Biology Pharmacology (Efficacy, MOA) Toxicology (IND-enabling safety) Cell Line and Process Development Clinical & Regulatory Pilot Plant and GMP Manufacturing |
8 NASDAQ: XOMA Process Development Process Development Cell Line Development Cell Banking Pilot Plant Production Assay Development Formulation Development Manufacturing Manufacturing cGMP Production Scale to 2750 L - 3 Trains Grams to Kilograms 15,000 sq ft Pilot Plant GMP Manufacturing Plant XOMAs Integrated Development and Manufacturing Capability |
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NASDAQ: XOMA Recognized Leader in Technology and Capabilities Leverage Technologies and Capabilities Manage Development and Financial Risks XOMA Strategy |
10 NASDAQ: XOMA Benefits from Collaborations Chiron provides validated antibody targets and leads for oncology products Goal: 1 IND each year Lexicon provides validated antibody targets Goal: Minimum of 3 products in 3 years Bring More Product Candidates into XOMAs Pipeline Utilize Complementary Capabilities from XOMA and Partners Manage Financial Risk Share Development Cost Utilize XOMA Infrastructure Provide Other Financial Resources Maintain Flexibility (e.g. Profit-Share or Royalty) |
11 NASDAQ: XOMA Marketed Product Marketed Product RAPTIVA ® Plaque Psoriasis Genentech XOMA Pipeline Highlights RAPTIVA ® Atopic Dermatitis Genentech CHIR-12.12 CLL/MM Chiron rBPI 21 / NEUPREX ® POHS, Burns, BMT Proprietary Clinical-Stage Candidates Clinical-Stage Candidates XMA005.2 Immunology Proprietary Multiple Candidates Oncology Chiron Metabolic mAb Type II Diabetes, Obesity Lexicon Genetics Anti-Gastrin mAb GI Cancers Aphton Early-Stage Programs Early-Stage Programs CIMZIA™ Rheumatoid Arthritis / Crohns Disease UCB Celltech Lucentis™ Wet AMD Genentech Bacterial Cell Expression Approximately 40 Licensees Merck, Wyeth, Others Technology Licenses Technology Licenses |
12 NASDAQ: XOMA Genentech and Serono Large Markets with Unmet Need Moderate-to-Severe Plaque Psoriasis Large Safety and Efficacy Database Increasing Worldwide Sales Atopic Dermatitis Trial RAPTIVA ® - Marketed Product Quarterly RAPTIVA ® U.S. and Worldwide Sales 2004 2005 Q1 Q2 Q3 Q4 Ex-U.S. U.S. 6.4 17.3 20.1 13.6 Q1 21.1 Q2 28.7 30.9 Q3 10 20 25 15 30 35 5 0 |
13 NASDAQ: XOMA Phase I Testing in CLL and MM Underway B-cell Lymphoma/Leukemia Indications Anti-CD40 mAb High Affinity, Fully Human Dual Mechanism of Action Blocks CD40-CD40L-mediated Cancer Growth Recruits Immune Cells to Kill Tumors (ADCC) No Agonist or Stimulatory Activity Improved Efficacy Compared with Rituxan ® CHIR 12.12 Anti-CD40 MAb |
14 NASDAQ: XOMA Product Large Safety Database Potent Endotoxin Neutralization Multiple Indications POHS, Burns, BMT BioDefense - ARS Clinical Plan IST for POHS Underway Burns and BMT ISTs Soon EU Orphan Drug Application rBPI 21 / NEUPREX ® |
15 NASDAQ: XOMA Potent Anti-inflammatory mAb Multiple Indications RA, OA, Others Product Human Engineered High Affinity mAb 300 fM Potent Inhibitory Activity Target Monthly Dosing Preclinical Stage Planned IND - Q406 Phase I - Q107 XMA005.2 -5000 5000 15000 25000 35000 45000 XMA005.2 Target Challenge Unstimulated Antibody, nM In Vivo Inhibition 0 10 20 30 40 50 60 70 80 90 100 0.4 0.13 0.04 0.013 In Vitro Neutralization XMA005.2 (ug/kg) |
16 NASDAQ: XOMA Marketed Product RAPTIVA ® for Moderate-to-Severe Plaque Psoriasis Clinical Stage Programs RAPTIVA ® (Phase II) Atopic Dermatitis CHIR-12.12 CLL, MM rBPI 21 /NEUPREX POHS, Burns, BMT Growing Early-Stage Pipeline XMA005.2 Multiple Oncology Candidates Metabolic mAb Technology Licenses-related Products CIMZIA ™ Lucentis ™ Pipeline Summary XOMA XOMA Building a Strong and Diverse Therapeutic Antibody Product Pipeline. |
17 NASDAQ: XOMA RAPTIVA ® Market Penetration CMO Deals NIAID, Cubist CIMZIA ™ and Lucentis ™ Royalty Possibilities CHIR-12.12 Clinical Progress rBPI 21 /NEUPREX Additional ISTs Business Development Initiatives Registration / Exchange Offer for Convertible Debt Revenue Growth, Reductions in Spending and Cash Burn, Size of Pipeline 2006 Catalysts |
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NASDAQ: XOMA Right Place, Right Time, By Design Maintain Leadership in Therapeutic Antibodies Leverage Technologies, Infrastructure and Capabilities Grow Pipeline Grow Revenues Manage Development and Financial Risks A Premier Therapeutic Antibody Company |
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Leader in Therapeutic Antibodies * * * |