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Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President
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Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

Dec 28, 2015

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Page 1: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

Medivir AB

Acumen BioFin 4th Annual Global Healthcare Conference

Lars Adlersson, CEO & President

Page 2: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

2

Basic facts

• Listed since 1996 (OME: MVIRB SS)

• MCap: ~ USD 180m

• 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

Page 3: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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The strategic journey

Successful outlicensing of 6 polymerase projects. Strong partnerships with deal value in excess of 400 MUSD plus royalties

Nordic marketing rights for all projects and possible product from J&J

Page 4: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Pipelines and partners

Page 5: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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OSTEOPOROSIS

HEPATITIS C

LABIAL HERPES

Key projects

Lipsovir®, Phase III data late 2007. Market approval by end of 2008.

Collaboration with Tibotec / Johnson & Johnson. Phase I trials ongoing.

MIV-701, Phase I trials ongoing.Further indications such as OA, RA and bone metastases explored.

Page 6: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Labial herpes (Lipsovir®)

• First drug to treat and prevent cold sores• Low-risk — based on safe, well-documented and already

marketed compounds • Goal: Marketing permission from regulatory authorities by

2008

Page 7: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Herpes virus

Immune defense

Page 8: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Herpes virus

Immune defense

Currentdrugs

Page 9: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Herpes virus

Immune defense

Lipsovir®

Page 10: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Treatment Prevention of cold soresReduction in

lesion healing time

Topical vs placebo

Acyclovir

Penciclovir

Docosanol (Abreva)

No

No

No

10 - 12%

13 - 15%

(15%)

Oral vs placebo

Acyclovir

Valaciclovir

No

No

9 - 13%

10 – 11%

Lipsovir® vs placebo Yes, 29% 11% (19%*)

* Episode duration

Lipsovir®: first to show prevention

Page 11: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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A billion dollar market

Annual value growth: 12%

Annual value growth: 9%

OTC(USD 220m)

Rx(USD 450m) Palliative

(USD 400m)

Page 12: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Development process

July 06 Jan 07 Mar 07 H2 07 H1 08 end-08 2009

StartPhase III

75%treated

60%treated

Phase IIIdata

Filing

Approval

GenitalHerpes?

MarketingPartner(s)

Page 13: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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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

Page 14: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Physician prescribing habits post- launch of Lipsovir®

Primary market researchBase: 225 physicians who have prescribed cold sore remedies 10+ times in the last 12 months

• 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)

Page 15: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Hepatitis C – HCV PI

Market

• 170-200 million infected

• Over 50% non-responders to current treatments

• Estimated market value in 2010: 7.8 billion USD

Process

• Partnership with Tibotec / Johnson & Johnson since November 2004

• Candidate drug selected 2005

• CTA submitted December 2006

• Phase I trials started February 2007

Patents

• Extensive and non-limiting IP published July 2005

Key enzyme for virus replication

Enzyme inhibiting compound

Page 16: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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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

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 (%)

0.955.420

Data on Compound “A” (an example from the lead series)

LO

M O

NH

R3

O

R2

R1

( )n

From presentations at the 1st International Workshop on Hepatitis C Resistance and New Compounds, Boston 25-26 October 2006and the 3rd Anglo-Swedish Medicinal Chemistry Meeting, 11-14 March 2007, Åre, Sweden

Page 17: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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Bone disorders (MIV-701)• 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 Back-up program in place with pre-CD’s selected

Bone surface

Osteoclast

Cath K

Page 18: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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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)

Page 19: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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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

“The Protease Discovery Engine”: A reliable repeat innovator

Page 20: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

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MIV-701

HEPATITIS C

LIPSOVIR

The journey ahead• Phase III data, autumn 2007• Partnership agreement(s)• Market registration, end-2008

• Phase I data during 2007• Possibility to receive “approved drug” from Johnson & Johnson

• 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

Page 21: Medivir AB Acumen BioFin 4th Annual Global Healthcare Conference Lars Adlersson, CEO & President.

LIPSOVILIPSOVI

RR®®

A profitable pharmaceutical companywith its own research and sales

Next step in company transformation