MediGene AG · LS:A40ESG
MediGene — Investor Presentation (November 2003)
40 slides from MediGene's investor presentation, November 2003
Slide 1: Fighting tumor diseases – Company Presentation
Fighting tumor diseases Company Presentation Nov_03 X1
Slide 2: Forward-looking statements
This presentation contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of the MediGene group as of the date of this presentation. These forward-looking statements are no guarantee for future performance. The
Slide 3: Agenda
Agenda Business Overview Products in Development Financials and Outlook Nov_03 X3
Slide 4: Business Overview
Business Overview Nov_03 X4
Slide 5: MediGene's mission
MediGene's mission MediGene aims to become a fully integrated biopharmaceutical company, focussing on tumor diseases. Nov_03 X5
Slide 6: MediGene's strategy
MediGene's strategy Become a fully integrated biopharmaceutical company focused on tumor diseases – via internal and external growth Maintain a well-balanced product portfolio – products in various stages of clinical development – proprietary technology platform Nov_03 X6
Slide 7: MediGene highlights
MediGene highlights German approval of Leuprogel®, the first product, expected in 2003 First data of clinical phase 3 for Polyphenon® E planned in Q1-2004 Leading in oncolytic HSV-technology Strong drug development expertise ranging from research through regulatory affairs Nov_03 X7
Slide 8: MediGene – the company at a glance
MediGene – the company at a glance Founded in 1994 Based in Martinsried, Germany (headquarters) and San Diego, USA (subsidiary) Publicly quoted on Germany's new Prime Standard Broad analyst coverage (e.g. Morgan Stanley, Goldman Sachs, Bank Vontobel, DZ Bank, M.M. Warburg, LBBW, etc.) Nov_03
Slide 9: MediGene discovers, develops, in-licenses and markets novel tumor therapeutics
MediGene discovers, develops, in-licenses and markets novel tumor therapeutics Drug Sales Product Portfolio • In- • Alliances licensing • Out- • M&A Proprietary Technology licensing Platforms Nov_03 X9
Slide 10: MediGene has experienced management
MediGene has experienced management Executive Board Peter Heinrich, PhD, CEO (Hoechst, Wacker) Alexander Dexne, CFO (Olympus Diagnostica) Broader Management Team K. Jon Kowal, PhD, SVP Research & Development (Chiron, Lederle) Axel Mescheder, MD, VP Clinic (Wyeth, Aventis) Claudius Wamlek, PhD, VP Bu
Slide 11: Well-balanced portfolio of novel cancer- and immunotherapeutics
Our technologies and in-licensing activities created a well- balanced portfolio of novel cancer- and immunotherapeutics Product Indication Clinical phase Approval Peak sales potential 1 2 3 Leuprogel® Prostate > 50 Mio. € cancer Polyphenon® E Genital > 100 Mio. € tumors NV1020 Liver > 200 Mio. € met
Slide 12: MediGene's IP position is strong
MediGene‘s IP position is strong Patents granted or allowed Patents pending Σ 41 Σ 33 10 Σ 30 8 4 Σ 19 31 26 9 25 Σ8 10 8 Germany U.S. Germany U.S. International Oncology HPV-Indications Nov_03 X 12
Slide 13: Strong drug development platforms are key
Strong drug development platforms are key – broad scientific network along the value chain Research Preclinical Clinical Process Marketing Development Development Development Wuxi Green Power, China CMOs (2) CROs (1) (1) Contract Research Organisation (2) Contract Manufacturing Organisation No
Slide 14: Products in Development
Products in Development Nov_03 X 14
Slide 15: Leuprogel – approval expected in 2003
Leuprogel® – approval expected in 2003 Product Indication Clinical phase Approval 1 2 3 Leuprogel® Prostate cancer Polyphenon® E Genital tumors NV1020 Liver metastases rAAV vaccine Malignant melanoma G207 Brain tumors Nov_03 X 15
Slide 16: Leuprogel addresses a growing market exceeding €550 million in Europe
Leuprogel® addresses a growing market exceeding € 550 million in Europe Prevalence of prostate cancer LHRH sales revenue Top 5 EU countries Top 5 EU countries (in € mn) 2001: 583,000 cases 163 /+ 8%* 2008: 670,000 cases +15 %* 160 140 111 /+ 8 % 120 107 /– 14 %* 106 /+ 10 % 100 92 / + 12 % 80 Compet
Slide 17: Leuprogel – improving hormone therapy of prostate cancer
Leuprogel® - improving hormone therapy of prostate cancer Combination of two approved components - Atrigel® drug delivery technology - Luteinizing Hormone Releasing Hormone (LHRH) – agonist standard therapy for prostate cancer Drug characteristics - Convenient administration - Efficient chemical cas
Slide 18: Leuprogel efficiently reduces testosterone levels without breakthroughs
Leuprogel® efficiently reduces testosterone levels without breakthroughs Clinical phase 3 data from 3 Month depot Leuprolide (ng/ml) Testosterone (ng/dl) 1000.0 Serum leuprorelin Serum Concentration (mean, SEM) and serum testosterone 100.0 < 50 ng/dl = clinical castration levels in advanced prosta
Slide 19: MediGene filed for registration of Leuprogel in Germany
MediGene filed for registration of Leuprogel® in Germany – further European countries will follow Clinical Prepare for Registration First development registration (Europe) approval One Month dose 2003 * expected eU S i n th ed 2003 u nc h Three Month dose la expected d y A lr e a Four Month dose Med
Slide 20: Analysts expect Leuprogel to reach peak sales in excess of 50 million €
Analysts expect Leuprogel® to reach peak sales in excess of 50 million € p.a. in Europe Registration Status Approval in Germany expected for 2003 Submission in further European markets in 2004 (Mutual Recognition Procedure) Objectives Conclude a pan-European marketing partnership Generate ro
Slide 21: Polyphenon E for the treatment of benign genital warts
Polyphenon® E for the treatment of benign genital warts Product Indication Clinical phase Approval 1 2 3 Leuprogel® Prostate cancer Polyphenon® E Genital tumors NV1020 Liver metastases rAAV vaccine Malignant melanoma G207 Brain tumors Nov_03 X 21
Slide 22: Polyphenon E targets a largely untapped market
With genital warts Polyphenon® E targets a largely untapped market Disease characteristics and current treatments Benign tumor disease caused by human papilloma virus infections Harmless but disfiguring and painful disease Surgical, physical and chemical treatment options currently available a
Slide 23: Genital warts is one of the fastest growing sexually transmitted diseases
Genital warts is one of the fastest growing sexually transmitted diseases Market data Patients with anogenital warts In Mio 9.8 US+Top 5 EU market for topical 10 treatments € 90 mn (20011)) 9 8 7.4 Expected market volume 7 Japan in 2005: € 160 mn 6 Spain Italy (CAGR2) appr. 15%)3) 5 Germany Fran
Slide 24: Polyphenon E generated convincing clinical results in a phase 2/3 trial
Polyphenon® E generated convincing clinical results in a phase 2/3 trial Efficacy: complete clearance • Ointment is as 90% efficacious and safe 80% as reported for the 70% major competitor 60% 50% • Clearance rate in 40% male patients better 30% than what is reported 20% for competing 10% products 0
Slide 25: Polyphenon E expected to reach the market by end of 2006
Polyphenon® E is expected to reach the market by the end of 2006 – pivotal phase 3 trials ongoing Study CT 1017 CT 1018 Design Randomized, double-blind, three-arm, parallel-group, placebo-controlled; 16 weeks treatment & 12 weeks follow-up Endpoints Complete clearance of warts Location EU / South Af
Slide 26: The Polyphenon E market is a growing market
The Polyphenon® E market is a growing market Aldara® and Condylox® sales Commercialization Strategy 171 Mio. USD (incl. off-label use) 180 Target groups: dermatologists, + 30% CAGR gynecologists, urologists, general 160 136 28 practitioners 140 120 100 21 Out-licensing to regional speciality pha
Slide 27: Oncolytic Herpes Simplex Viruses (HSV) for the treatment of cancer
Oncolytic Herpes Simplex Viruses (HSV) for the treatment of cancer diseases Product Indication Clinical phase Approval 1 2 3 Leuprogel® Prostate cancer Polyphenon® E Genital tumors NV1020 Liver metastases rAAV vaccine Malignant melanoma G207 Brain tumors Nov_03 X 27
Slide 28: Why oncolytic HSV to treat cancer?
Why oncolytic HSV to treat cancer ? High therapeutic potential… …through the killing of cancerous cells ...has been demonstrated in preclinical and clinical studies High selectivity for cancerous cells… …by targeting the underlying mechanism of tumor growth ...can positively impact the side-effect p
Slide 29: Oncolytic HSV – designed to selectively kill cancer cells
Oncolytic HSV – designed to selectively kill cancer cells A. Wild-type HSV A. Wild-type HSV carries all genetic information necessary to productively infect normal cells. After replication of HSV, normal cells are lysed and virus progeny is released. B. Oncolytic HSV B.1. Oncolytic HSV is attenuated
Slide 30: NV1020 – liver metastases of colon cancer have high unmet medical need
NV1020 – patients with liver metastases of colon cancer have a high unmet medical need US 73,986 Median survival time < 1 year Japan 41,604 50 % of patients with colon Germany 30,407 cancer develop France 17,258 liver metastases1 UK 16,587 ~80 % of these patients have Italy 16,658 unresectable
Slide 31: NV1020 – promising results from a completed phase 1 trial
NV1020 – promising results from a completed phase 1 trial in patients with liver metastases of colon cancer Study conducted at the Memorial Sloan-Kettering Cancer Center 12 patients Treatment: locoregional viral perfusion ng/ml 100 Chemo into the liver followed by chemotherapy Primary endpoint
Slide 32: NV1020 – next clinical trial planned to begin in 2004
NV1020 – next clinical trial planned to begin in 2004 Main objectives in future clinical development Safety and tolerability of repeated doses Anti-tumor activity of NV1020 as monotherapy and in combination with chemotherapy Patient population Colorectal cancer metastatic to liver Liver-domi
Slide 33: Partnership with Aventis to develop a novel rAAV tumor vaccine
Partnership with Aventis to develop a novel rAAV tumor vaccine Product Indication Clinical phase Approval 1 2 3 Leuprogel® Prostate cancer Polyphenon® E Genital tumors NV1020 Liver metastases rAAV vaccine Malignant melanoma G207 Brain tumors Nov_03 X 33
Slide 34: Tumor vaccine to treat malignant melanoma
Tumor vaccine to treat malignant melanoma - first clinical application of recombinant rAAV technology in Europe Conduct phase 3 Develop vaccine & clinical trials Joint rAAV technology Manufacturing development Revenues: Regulatory and milestone, up-front commerciali- and license approval p
Slide 35: Financials and Outlook
Financials and Outlook Nov_03 X 35
Slide 36: Nine-Months 2003 financials at a glance
Nine-Months 2003 financials at a glance Cash position of € 27.7 mn as of September 30th, 2003 Average net cash burn rate of € 2.2 mn per month in first nine months 2003 Development expenses of € 19 mn down from € 26.6 mn in first nine months 2002 Net loss decreased by 19 % from € 29.6 mn to
Slide 37: Financial Outlook 2003
Financial Outlook 2003 Net loss of approx. € 30 mn (excl. Leuprogel partnership) Cash position of € 20 mn at the end of 2003 Current assumptions in the business plan beyond 2003: - Marketing partnership for Leuprogel® - Development and marketing partnership for Polyphenon® E - Development and
Slide 38: Facts about the MediGene stock
Facts about the MediGene stock Shareholder Structure Listed in the Prime Standard technology segment of Management & supervisory board 10 % Deutsche Börse (Nemax 50) Institutional investors 12 % Ranked # 16 in terms of liquidity (100.000 shares per day) and # 38 in terms of market cap (€ 63 mio)
Slide 39: MediGene highlights
MediGene highlights Drug pipeline with late-stage products - Leuprogel® expected to receive approval in 2003 - Polyphenon® E in phase 3 development - Further products in clinical development Proprietary technology platforms to feed pipeline with innovative products Drug development expertise r
Slide 40: MediGene AG contact details
MediGene AG Lochhamer Straße 11 82152 Planegg / Martinsried, Germany Phone: +49 89 85 65 29 00 Fax: +49 89 85 65 29 20 MediGene Inc. 9880 Campus Point, Drive A San Diego, CA 92121, USA www.medigene.com Nov_03 X 40