the presenters from medivir at the carnegie lunch january 21 lars adlersson ceo prof bertil...
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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
2
2
1
1
12
2 2 1 1
3222
1
1 1 1 2
1
2
1
11
3
3
2
3
1
3
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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)
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