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Page 1 Orexo Annual General Meeting 2009

Page 1 Orexo Annual General Meeting 2009. An eventful year for Orexo Page 2 Abstral TM – Launched in UK, Germany and Sweden – Planned for launch in

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Page 1

Orexo

Annual General Meeting 2009

An eventful year for Orexo

Page 2

AbstralTM

– Launched in UK, Germany and Sweden

– Planned for launch in France and Spain during H2 2009

– Licence and/or distribution agreements in China and Israel

– ProStrakan becomes new partner for AbstralTM in the US - increased royalties both in EU and the US

EdluarTM

– Licensed to Meda (together with OX-NLA) – total revenue to date USD 25m

– Approved by the FDA in March 2009 – Meda expects to launch EdluarTM in the US during H2 2009

Two products commercialized

Page 3

Acquisition of a UK drug delivery company PharmaKodex – in line with Orexo’s fundamental strategy to develop superior drugs using well established and effective drug molecules

OX17 – exclusive development agreement with a large healthcare company

Extension of Boehringer-Ingelheim research partnership regarding OX-MPI

Indifferent results on OX914 in experimental model of allergic rhinitis

An eventful year for Orexo

Development of the product portfolio

Page 4

Share price development since January 2008

* Index rebased to Orexo’s share priceShare price development until 2009-04-21

OMXS-PI -34%

OMX-biotech -26%

Orexo -20%

FDA approval of EdluarTM

Phase II data on OX914

Agreement in China and Israel

ProStrakan – new partner in the US

AbstralTM approved in Europe

Licensing deal with Meda

SEK*

2008 2007SEKm 12 months 12 months % Change

Net revenues 223.6 103.1 +117%

Cost of goods sold -15.1 -13.7 +10%

Gross profit 208.5 89.4 +133%

Selling expenses -30.2 -23.6 +28%

Administrative expenses -52.8 -84.3 -37%

R&D costs -237.6 -255.5 -7%

Other operating income and costs 3.8 0.6 n.m.

Operating result -109.6 -273.4 +60%

Favourable financial development in 2008Pro forma figures - excluding ProStrakan AB and costs for employee stock options

SEK 188m in cash at year end

SEK 71.8m of R&D costs were re-invoiced to partners in 2008

(Pro forma)

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Executive management team

Thomas LundqvistExecutive Vice President & Head of Pharmaceutical and Clinical R&D. M.Sc. Pharm.

Torbjörn BjerkePresident and CEO, MD

Claes WenthzelExecutive Vice President & CFO, B.Sc. Bus. Adm.

Charlotte EdeniusChief Scientific Officer & Head of Preclinical R&D, MD, PhD

Robin WrightSVP Business & Commercial Development

Gunilla Ekström SVP Project ManagementPhD. MD.

Future priorities

Expand topline revenue

Business and project development

Key business focus in 2009

1

2

3

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AbstralTM - approvals in key markets

Sweden

Denmark UKGermany

France

Spain

Hungary

Page 8

Austria

Iceland

Current treatmentCurrent treatment The ideal (Abstral™) treatment approachThe ideal (Abstral™) treatment approach

AbstralTM – an ideal treatment for breakthrough cancer pain

Source; Datamonitor, 2006

Page 9

“Top-down” sales and marketing strategy

Dissolves quickly – local absorption over the sublingual mucosa

Fast and reproducible onset of action

Low risk of non-absorbed fentanyl

Easy dosage, storage and handling

Competitive advantage:Competitive advantage:

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Partnering agreements worldwide- to capture the full potential of AbstralTM

Europe:

Royalty on sales 25% - 30%

Sales milestones EUR 19.9m

Approval milestones EUR 3.25m (EUR 2.6m received)

Japan:

Tiered single digit royalty

Development milestones of USD 2m

Approval milestones USD 3m

North America:

Royalty on sales 23% - 28%

Sales milestones USD 25m

Milestone of USD 2m at submission of NDA to the FDA Australasia /

Southeast Asia

Russia / CIS

China:

Milestones USD 4.75m

IsraelIsrael

Page 11

EdluarTM – sublingual zolpidem for insomnia

Status:

FDA approved

Partner Meda expects to launch the product in the US market in H2 2009

The approval triggered a USD 5 million milestone from Meda

Royalties once Meda has launched the product - potential for further sales milestones

Product characteristics:

Sublingual tablet, 5 mg and 10 mg

Rapid onset of action

No need for water

Use in adult and geriatric patients

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Sales company in Nordic region

50:50 ownership

Tostrex ® Testosterone gel

Rectogesic ®

Anal fissures

Joint venture with ProStrakanExpanding our own sales and marketing capabilities

Abstral ®

Breakthrough cancer pain

Dridol®

Nausea

Page 13

Orexo subsidiary: - strong sales development

Sales company

Third party manufacture

Products for diagnosis of the ulcer-causing bacterium Helicobacter pylori

Sales development 2004-2008

Diabact® UBT

Heliprobe® System

Page 14

Future priorities

Expand topline revenue

Business and project development

Key business focus in 2009

1

2

3

Page 15

Preclinical phase Clinical phase Commercialized products

Rapinyl®/Abstral™

Indication: Breakthrough cancer painPartners: ProStrakan (US & EU),

Kyowa Hakko Kirin (Jpn)Gedeon Richter, Hospira,Novamed, Neopharm

Edluar™

Indication: InsomniaStage: Launch H2 2009 Partners: Meda (global)

Diabact®Heliprobe®

Indication: Diagnostic Helicobacter pyloriPartners: Distribution partners

across Europe, CIS and Middle East

OX-MPI

Indication: Pain & inflammationStage: PreclinicalPartners: Boehringer Ingelheim

OX17

Indication: GERDStage: Phase II/IIIPartners: Not disclosed

OX219

Indication: Opioid AddictionStage: Ready for clinical phaseObjective: Own sales

Indication: COPDStage: Phase II

OX-AAF

Indication: Asthma & COPDStage: Preclinical

OX641

Indication: MigraineStage: Formulation

OX-PKX

Stage: Various consumer healthand Rx products

Objective: Big pharma partners

OX-NLA

Indication: RhinitisStage: Phase III readyPartners: Meda AB

Page 16

Product portfolio with significant opportunities

Projects with licence or development agreement

Page 17

Acquisition of UK drug delivery company

Provides a number of partnership license opportunities in consumer health products

Strengthens Orexo’s product portfolio and enables new opportunities for product development

Pandermal

Taste Transformation

Xerosol

OX219 – therapy for opioid addiction

Opioid-addiction therapy drug, containing buprenorphine and naloxone

Superior to Suboxone™ (Reckitt-Benckiser*), with significant advantages:

– Taste– Speed of Dissolution/compliance– Lower abuse potential– Dosage forms

Suboxone™ sales are USD ~800 million globally

Currently reformulating product for regulatory route

* Sold by Schering Plough in EU

Page 18

Future priorities

Expand topline revenue

Business and project development

Key business focus in 2009

1

2

3

Page 19

Key business focus in 2009 in order to deliver shareholder value

Page 20

Continue the transition to become a sales driven company

– Support partners on the sales of AbstralTM and EdluarTM

– Secure growth in the Nordic J/V with ProStrakan

– Finalise new revenue generating agreements

– Secure organic growth in Kibion

Focus on future growth

– New projects from own organisation - if the financial resources allow

– In-license/acquire late stage assets and commercial products

Focus on the cost base

– Continue to increase internal efficiency and reduce cost base

Towards profitability in Orexo – potential news flow in 2009 Approval and launch of AbstralTM in additional European

markets

Partnership agreement for the Arachidonic Acid Franchise

Partnership agreement for OX914 program

Further distribution deals for AbstralTM

FDA filing of Rapinyl/AbstralTM in the US

Full license agreement with OX17

Launch of EdluarTM in the US by partner Meda

Next milestone for OX-MPI with Boehringer Ingelheim

Deals involving platforms/projects from PharmaKodex

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