Medivir AB Carnegie Health Care Seminar May 2007 Lars Adlersson, CEO & President Börje Darpö, VP Development Rein Piir, CFO / IR.

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Presentation transcript:

Medivir AB Carnegie Health Care Seminar May 2007 Lars Adlersson, CEO & President Börje Darpö, VP Development Rein Piir, CFO / IR

Basic facts 18 month performance Listed since 1996 (OME: MVIRB SS) MCap: ~ USD 190m Major shareholders: Staffan Rasjö Founders Handelsbanken Den Norske Bank Skandia Cash position: SEK 370m (end-Q1) Revenues: SEK 129m (FY 2006) Burn rate: SEK 155m (FY 2006) 18 month performance

The strategic journey Nordic marketing rights for all projects and possible product from J&J Successful outlicensing of 6 polymerase projects. Strong partnerships with deal value in excess of 400 MUSD plus royalties

Pipelines and partners

Key projects LABIAL HERPES Lipsovir®, Phase III data late 2007. Market approval by end of 2008. HEPATITIS C Collaboration with Tibotec / Johnson & Johnson. Phase I trials ongoing. OSTEOPOROSIS MIV-701, Phase I trials ongoing. Further indications such as OA, RA and bone metastases explored.

Labial herpes (Lipsovir®) Herpes virus Immune defense

Herpes virus Current drugs Immune defense

Herpes virus Lipsovir® Immune defense

Prevention of cold sores Reduction in episode duration Lipsovir®: first to show prevention Treatment Prevention of cold sores Reduction in episode duration Topical vs. placebo Acyclovir Penciclovir Docosanol (Abreva) No 10 to 12% 17% 15% Oral vs. placebo Valaciclovir 9 to 20% Lipsovir® vs. placebo Yes, 29% 19%* All available antiviral therapies for labial herpes, administered either orally or topically, have a very modest effect on the episode duration of the lesion. The observed effect has, in most studies, been in the range of half-a-day to around 1 day, which corresponds to a reduction in episode duration of 10 to 20%. No existing therapy has been shown to be effective at preventing cold sores. On the other hand, Lipsovir can prevent recurrences of labial herpes - in up to 30% of cases. In addition, patients in whom the recurrence is not prevented, and who do develop classic ulcerative lesions, benefit from the same or even a higher reduction of episode duration. * In the Lipsovir study, where prevention of cold sores was demonstrated, the reduction of episode duration refers only to those patients who developed ulcerative lesions. 9

Development process Marketing Partner(s) 60% treated Phase III data Approval July 06 Jan 07 Mar 07 H2 07 H1 08 end-08 2009 Start Phase III 75% treated Genital Herpes? Filing Marketing Partner(s)

A billion dollar market Annual value growth: 9% Rx (USD 450m) Palliative (USD 400m) OTC (USD 220m) Annual value growth: 12%

Three of four sufferers express an interest in Lipsovir® Definitely would buy Probably would buy Might or might not buy Probably would not buy Definitely would not buy Primary market research 403 (UK) 411 (US) respondents

Physician prescribing habits post- launch of Lipsovir® Physicians are willing to prescribe a new cold sore remedy When asked what they would prescribe on the next 10 occasions, Lipsovir claims a 45% share of prescriptions, making it the leading product and drawing users from all 3 principal Rx brands (Zovirax, Valtrex, Denavir) Primary market research Base: 225 physicians who have prescribed cold sore remedies 10+ times in the last 12 months

Hepatitis C – Opportunities to improve current therapy Curing a larger proportion of patients Less than 50% of patients with most common genotype G1 (>70% in the US) respond to current therapy (peg-Interferon  + ribavirin) Decreasing duration of therapy Currently 48 weeks for most common and difficult-to-treat genotype 1 Improving tolerability Standard-of-care associated with severe side effects (flu-like symptoms, fatigue, depression, hemolytic anemia) Contraindicated in patients with decompensated liver failure

Hepatitis C – Medivir/JNJ program NS3/4A: Key protease for virus replication Process Partnership with Tibotec / Johnson & Johnson since November 2004 Phase I trials ongoing since February 2007 Strong back-up program Patents Extensive and non-limiting IP published July 2005 Collaboration agreement Research funding, milestones & royalty Rights to receive pharmaceutical product for Nordic countries from JNJ at pre-defined point in development Nordic rights retained by Medivir Enzyme inhibiting compound

Medivir/Tibotec HCV PI Series Several series of highly promising NS3/4A inhibitors have been developed Further optimization of these inhibitors in collaboration with Tibotec Pharmaceuticals Ltd, J&J, has resulted in the selection of a Clinical Candidate Data on Compound “A” (an example from the lead series) Enzymatic activity on genotype 1b (Ki, nM) <1nM Replicon activity on genotype 1b [IC50, nM] <10nM In vivo PK, Oral dose: 10 mg/kg Cmax (µM) T 1/2 (h) F (%) 0.95 5.4 20 From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006 and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden

Bone disorders (MIV-701) Bone surface MIV-701 selectively inhibits the bone and cartilage degrading enzyme cathepsin K Osteoporosis, osteoarthritis and bone metastases Target profile: Improved bone quality (c/f bisphosphonates) Bone growth capability Once-daily oral dosing Strong Follow-on program in place with pre-CD’s selected Cath K Osteoclast

Bone disorders (MIV-701) Market Approx 100 million patients in major growing markets (osteoporosis only) Global osteoporosis market 11 billion USD by 2008 Strong interest in cathepsin K inhibition from major pharma companies Process Clinical phase Ia trials commenced March 2007 Phase Ib trials planned for late 2007 Patent/generic competition Patent applications being processed Expected patent protection until 2025 Partner strategy Establish industrial partnership after completion of phase Ib (2008)

“The Protease Discovery Engine”: A reliable repeat innovator HIV – PI Collaboration project with Tibotec / Johnson & Johnson MMP- COPD Collaboration with Hengrui Extensive IP, excellent results in pre-clinical disease model Next step: selection of Candidate Drug Renin - Hypertension IP compiled for three distinct and potent inhibitor series Next step: studies in a pre-clinical efficacy model Cathepsin S – RA, MS and pain Potent and selective inhibitors Efficacious in preclinical disease models Fine-tuning of PK properties Several early protease programs, e.g. Alzheimer's (BACE inhibitors) and novel cholesterol lowering MOA Large inhibitor libraries and proprietary technologies facilitate CD generation against any new protease target

Business model Structure: Revenue streams: Research & development of protease inhibitors Upfronts & milestones Royalties Sales & marketing of proprietary products Pharmaceutical sales revenues Quids Own products (e.g. HIV Franchise, HCV PI) Acquired products

Key Events Going Forward LIPSOVIR Phase III data, autumn 2007 Partnership agreement(s) Market registration, end 2008 HEPATITIS C Phase I data during 2007 Possibility to receive “approved drug” from Johnson & Johnson MIV-701 Phase I data during 2007 Partnership post phase I HIV FRANCHISE MIV-170: Entry into phase I by late 2007 MIV-606 start of phase IIb trials New clinical trials and new data in other out- licensed projects

A profitable pharmaceutical company with its own research and sales Next step in company transformation LIPSOVIR® A profitable pharmaceutical company with its own research and sales