Transcript PowerPoint-presentation

The presenters from Medivir
at 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
2
2
3
3
1
3
Phase I
2
2
1
1
1
1
Preclin. development.
1
1
1
2
1
2
3
2
1
2
2
1
Late research
2
1
1
Research
2
1
2
Lipsovir
Protease based
Polymerase based
(HIV Franchise & HCV Pol)
2
2
3
2
1
3
 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
Sales
Operating cost
Cash burn
Cash year end
2003
64
-166
-93
239
2004
85
-182
-85
441
2005
105
-186
-73
302
2006
129
-270
-140
195
2007 P
240
-276
-41
370
Partners
Clinical
Preclinical
2003
4
3
2004
3
4
2005
1
2
2006
4
6
2007
5
4
MSEK
Future potential sources of revenues
Existing license
agreements
Potential new
license agreements
Pharma Sales
HEPATITIS C PI
(TMC 435350)
LIPSOVIR
QUID(S)
HIV PI
MIV 701
& new cathepsin K inhibitors
CO-PROMOTION
HIV Franchise Partners
Late Discovery Projects
(COPD )
ACQUISITIONS
Other Discovery Projects
(BACE, Renin and cathepsin S)
Future revenues will be used to finance operations towards
profitability and to build pharma sales
Pipeline
January 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
Operational focus and activities 2008 1(2)
LIPSOVIR
HEPATITIS C
(TMC-435350)
CATHEPSIN K
(MIV-701)
COPD, Renin,
BACE etc
• 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
• Broad preclinical program – follow-on candidate drug
to be selected during the spring
• The partnering process will be initiated shortly
• Evaluate interest for broad partnerships
Operational focus and activities 2008 2(2)
PHARMA SALES
HIV FRANCHISE
FINANCE
• 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
• 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