The presenters from Medivir at the Carnegie lunch January 21 Lars Adlersson CEO Prof Bertil...

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The presenters from Medivir at the Carnegie lunch January 21 Lars Adlersson CEO Prof Bertil Samuelsson, VP Discovery and Research Rein Piir, CFO / IR

Transcript of The presenters from Medivir at the Carnegie lunch January 21 Lars Adlersson CEO Prof Bertil...

The presenters from Medivirat the Carnegie lunch January 21

Lars Adlersson CEO Prof Bertil Samuelsson, VP Discovery and

Research Rein Piir, CFO / IR

Stabilizing the business by entering new therapeutic areas

Projects in pipeline 2003 2004 2005 2006 2007

Phase III

Phase II

Phase I

Preclin. development.

Late research

Research

Lipsovir

Protease based

Polymerase based(HIV Franchise & HCV Pol)

2

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3222

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90% of 2007 deal value is linked to protease based projects 100% of internal resources are invested in protease based projects, Lipsovir being the only exception

Stabilizing the business by adding a mix of partnership structures

Partners 2003 2004 2005 2006 2007Clinical 4 3 1 4 5Preclinical 3 4 2 6 4

MSEK 2003 2004 2005 2006 2007 P

Sales 64 85 105 129 240

Operating cost -166 -182 -186 -270 -276

Cash burn -93 -85 -73 -140 -41

Cash year end 239 441 302 195 370

Future potential sources of

revenues Existing license

agreements

HIV PI

HEPATITIS C PI(TMC 435350)

HIV Franchise Partners

Potential newlicense agreements

MIV 701& new cathepsin K inhibitors

LIPSOVIR

Late Discovery Projects(COPD )

Pharma Sales

QUID(S)

CO-PROMOTION

ACQUISITIONS

Future revenues will be used to finance operations towards profitability and to build pharma sales

Other Discovery Projects(BACE, Renin and cathepsin S)

PipelineJanuary 2008

TMC4353350 - Phase IIa Clinical Trial

• The OPERA-1 trial will assess the number of patients that achieve RVR (undetectable virus at week 4)

• The OPERA-1 trial will be able to assess number of patients achieving SVR (after 4 weeks of combo therapy plus 24 or 48 weeks of IFN plus RBV)

• The Phase IIa RVR data available already H1 2008, will initiate the design and start of the phase IIb trial (OPERA-2)

• Statement - There is a place for next generation HCV PI like TMC435350 with:

High potency – low drug load Once-daily – good compliance resulting in increased efficacy Large forgiveness factor – higher efficacy Less side effects – possible from shorter duration of treatment More treatment options – exclude ribavarin from therapy

HEPATITIS C(TMC-435350)

LIPSOVIR

Operational focus and activities 2008 1(2)

• First to prevent outbreaks of cold sores?• Phase III results available late Q1 2008• Partnering discussions ongoing• The aim is to have the commercial strategy, including partner/s in place by the end of 2008• First regulatory approval is expected H1 2009

• Phase Ib completed with excellent results – to be presented in April• Phase IIa initiated – results will probably be presented in Q4• Phase IIb could start before year end

CATHEPSIN K(MIV-701)

• Broad preclinical program – follow-on candidate drug to be selected during the spring• The partnering process will be initiated shortly

COPD, Renin, BACE etc

• Evaluate interest for broad partnerships

HIV FRANCHISE

PHARMA SALES

Operational focus and activities 2008 2(2)

• Portfolio sourcing exercise has begun• Co-marketing discussions with a few selected companies initiated• Infrastructure can be put in place with short notice

• Two phase IIb trials with Valomaciclovir recently initiated Head-to-head vs market leader for shingles – once daily vs three times daily and for the treatment of acute infectious mononucleosis • Chinese condom coating initiative well underway

FINANCE• Cash end-of 2007 ~SEK 370m• Substantially lower expenses level (appr. SEK 190m) during 2008 • Future revenues will be used to extend runway and build pharma sales