Neopharm Co., Ltd. · KRX:092730
Neopharm — Investor Presentation (August 2006)
24 slides from Neopharm's investor presentation, Aug 2, 2006
Slide 1: NeoPharm
@® NEOPHARM NASDAQ: NEOL
Slide 2: Safe Harbor Statement
Safe Harbor Statement Various remarks that we may make about future expectations, plans and prospects for the Company constitute forward-looking statements for purposes of the Safe-Harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from
Slide 3: Strategic Vision: Focus on Execution
Strategic Vision “Focus on Execution” Focus on Core Assets Cintredekin Besudotox (CB, IL13-PE38QQR, IL13) NeoLipid® liposomal technology Prioritize Product Portfolio Assessing best regulatory pathway Focus on life cycle management Cost/ROI potential Transition to Fully Integrated Biopharmaceutical C
Slide 4: IL13-PE38QQR (cintredekin besudotox): Potential New Treatment for Glioblastoma Multiforme
IL13-PE38QQR (cintredekin besudotox) Potential New Treatment for Glioblastoma Multiforme Tumor targeted-cytotoxin (development rationale) GBMs highly express IL13 receptors, healthy cells do not IL13-PE38 binds to IL13 receptors like a “key in a lock” GBMs internalize IL13-PE38 and die Healthy cells
Slide 5: About Glioblastoma Multiforme (GBM): Targeted Treatment is Key
About Glioblastoma Multiforme (GBM) Targeted Treatment is Key Unique Characteristics Affects adults and children, males and females 3rd leading cause of cancer death in persons 15-35 years of age Most aggressive tumor in oncology Located and stays in brain Highly infiltrative Limited Treatments Dism
Slide 6: Newly Diagnosed and Recurrent GBM Patient Populations
Total Newly Diagnosed GBM Population* Resectable Newly Diagnosed GBM Patients** Resectable Recurrent GBM Patients*** * USA patient data only ** 84% of Newly Diagnosed patients are resectable *** 34% of Recurrent GBM patients are resectable GBM patient population growing 1.5% CAGR/yr (not including 2
Slide 7: Cintredekin Besudotox (CB): The Path to Obtaining Approval, Phase III PRECISE Trial
Cintredekin Besudotox (CB) The Path to Obtaining Approval Phase III PRECISE Trial 294 Patients Enrolled with 276 Intent-to-Treat Randomized 2:1 [2 CB: 1 Gliadel] Sized and Powered @ 80% to achieve 50% improvement in median survival PRECISE Trial End Point Statistically significant separation of the
Slide 8: The PRECISE Trial (CB versus Gliadel): The Path to Obtaining Approval
The PRECISE Trial (CB versus Gliadel) The Path to Obtaining Approval 9 Months 11 Months 14 Months Observed separation between patient enrollment and patient deaths 12+ months Enrollment Completed 50 100 160 225 210 174 153 100 52 0 50 100 150 200 250 300 'Jun-04 'Aug-04 'Oct-04 'Dec-04 'Feb-05 'Apr-
Slide 9: CB in Initial GBM Diagnosis: The Path to Obtaining Approval
CB in Initial GBM Diagnosis The Path to Obtaining Approval 10/05 12/04 12/04 07/04 1st patient enrolled Last patient enrolled 05/06 85 6 7 IV 68 13 19 Total 3 6 3 N= 66+ 66 2 III 56 50 3 II 86+ 66 2 I Overall Survival (weeks) % Still Alive # of Patients Alive Cohort Source: Vogelbaum, American Assoc
Slide 10: CB Phase I compared to Gliadel Phase III: Overall Survival Rates
CB Phase I compared to Gliadel Phase III* Overall Survival Rates Source: Gliadel Data Gliadel package insert Gliadel median survival: 28 weeks Placebo median survival: 20 weeks Source: CB Data Phase I Experience (AANS 2006) Overall median survival: 44 weeks Optimal catheter placement: 53.6 weeks Sub
Slide 11: The Path to Obtaining Approval Summary
The Path to Obtaining Approval Summary Phase III (PRECISE Trial) in First Recurrent GBM (Extrapolated data) Encouraging preliminary data; final data expected 1Q07 Phase I Data in Recurrent GBM 44 Weeks – Overall Median Survival 52 Weeks – Median Survival w/Adequate Catheter Placement 70 Weeks – Medi
Slide 12: Strategic Vision: Focus on Execution
Strategic Vision “Focus on Execution” Focus on Core Assets Cintredekin Besudotox (CB, IL13-PE38QQR) NeoLipid® liposomal technology Prioritize Product Portfolio Assessing best regulatory pathway Focus on life cycle management Cost/ROI potential Transition to Fully Integrated Biopharmaceutical Company
Slide 13: Liposomal Technology & Market Opportunity
Liposomal Technology & Market Opportunity Small size ~150-200 nanometers Uniform manufacturing 95% at <200 nanometers Entrapment efficiency >80% Easy to use Either lyophilized or liquid Electrostatic charge of lipid provides increased solubility Enhances drug delivery Market Size/Opportunity Breast
Slide 14: Liposomal Technology
Liposomal Technology Define Target Product Profile Early Focus on products that support life cycle management opportunities Assess Product Opportunity Focus on differentiated products Market entry position (1st or 2nd) is optimal, but not essential Business development opportunities Market potential
Slide 15: Portfolio Optimization: LE-SN38 – Liposomal SN38
Portfolio Optimization LE-SN38 – Liposomal SN38 Initiated Phase II (CALGB co-operative group) in 2 nd Line Metastatic Colorectal Cancer SN38 is active drug of Camptosar ® (pro-drug) Camptosar (Irinotecan, Pfizer), 2005 sales of $900MM+ Patent Expiration = 2007 Approved for metastatic colorectal canc
Slide 16: Portfolio Optimization: LEP-ETU – Liposomal Paclitaxel
Portfolio Optimization LEP-ETU – Liposomal Paclitaxel Preparing for Phase III via 505(b)(2) pathway Based on non-inferiority with superiority advantage over Taxol in breast cancer Taxol ® (Paclitaxel, Bristol Myers Squibb) Competing in a $1 billion paclitaxel market, Patent Expiration = 2002 Approve
Slide 17: Portfolio Optimization: LE-DT and LE-GEM
Portfolio Optimization LE-DT – Liposomal Docetaxel Pre-clinical, IND targeted in 2007 Taxotere ® (Docetaxel, Sanofi-Aventis), 2005 Global Sales = $2.5 Billion Patent Expiration = 2012 Approved for non-small cell lung cancer (NSCLC), prostate cancer, metastatic breast cancer LE-GEM – Liposomal Gemcit
Slide 18: Strategic Vision: Focus on Execution
Strategic Vision “Focus on Execution” Focus on Core Assets Cintredekin Besudotox (CB, IL13-PE38QQR) NeoLipid® liposomal technology Prioritize Product Portfolio Assessing best regulatory pathway Focus on life cycle management Cost/ROI potential Transition to Fully Integrated Biopharmaceutical Company
Slide 19: Transforming into a Fully Integrated Biopharmaceutical Company
Transforming into a Fully Integrated Biopharmaceutical Company Recruitment and Staffing of Commercial Entity Tim Walbert, EVP, Commercial Operations HUMIRA Global Launch Team Celebrex International and US Marketing Building commercial oncology franchise to support launch of cintredekin besudotox Add
Slide 20: Strategic Vision: Focus on Execution
Strategic Vision “Focus on Execution” Focus on Core Assets Cintredekin Besudotox (CB, IL13-PE38QQR) NeoLipid® liposomal technology Prioritize Product Portfolio Assessing best regulatory pathway Focus on life cycle management Cost/ROI potential Transition to Fully Integrated Biopharmaceutical Company
Slide 21: Strong Fiscal Management
Strong Fiscal Management Short Term Financing Resolved January 2006 Financing 4.0 M shares @ $10.20/share $39.0M proceeds net of discount and underwriting commissions April 2006 Cost Rationalization Program 23% workforce reduction to eliminate redundant or unnecessary positions July 2006 Consolidati
Slide 22: Financial Highlights
Financial Highlights $ in Millions 2005 (Actual) 2006 (Projected) Cash & Investments $30.3 $35.0+ Debt $0.0 $0.0 Net Loss ($38.7) ($36.0-38.0) $ in Millions
Slide 23: Strategic Vision: Focus on Execution
Strategic Vision “Focus on Execution” Focus on Core Assets Cintredekin Besudotox (CB, IL13-PE38QQR) NeoLipid® liposomal technology Prioritize Product Portfolio Assessing best regulatory pathway Focus on life cycle management Cost/ROI potential Transition to Fully Integrated Biopharmaceutical Company
Slide 24: Question & Answer
Question & Answer N EOPHARM , Inc. 1850 Lakeside Drive Waukegan, IL 60085 (847) 887-0800 www.neopharm.com