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Orexo
                         Nordea Healthcare Seminar
                          15-16 September, 2009
Page 1




 Orexo – building for profitability
     Two main platforms – Drug Delivery and Discovery

     Strong focus on innovative d
     S      f        i      i drug d
                                   development
                                       l

     2 products launched on major markets within the last
     12 months - AbstralTM (EU) and EdluarTM (USA)
     Strong pipeline delivering real value for the long term

     Revenue-generating partnerships with:
         – ProStrakan     – Kyowa Kirin
         – Meda           – Boehringer Ingelheim
         – Novartis

     Listed on NASDAQ-OMX Stockholm:
     Ticker: ORX; Market capitalization SEK 936m(1)
                        1) Market capitalization as of September 9, 2009
Page 2




                                                                           1
Strong position to capture value



                                 Launched                        Partnered          Partnered            Owned
    Launched                                                                                           Development
                                 Diagnostic                     Development         Discovery          & Discovery
    Products
                                  Products                       Programs           Programs            Programs


Abstral™                       Kibion                           OX17               OX-MPI              OX219

Edluar™                                                         OX-NLA                                 OX914*

Joint Venture                                                                                          OX-PKX*

                                                                                                       OX-AAF*

                   * In Partnering discussions
Page 3




     AbstralTM – showing strong growth in EU
                                                                                 Breakthrough cancer pain attacks
           Sublingual fentanyl tablet for the                                    (millions / year(1))
           management of breakthrough cancer p
                 g                     g      pain

           Fast acting and convenient administration

           Partnered in Europe, North America and
           Japan
           Launched in UK, Germany, France and
           Sweden – planned launch in Spain in H2
           2009

           NDA filed in the US by partner ProStrakan




  Page 4      1) Source: Datamonitor; Europe includes the five largest markets




                                                                                                                     2
Partnering agreements worldwide
- to capture the full potential of AbstralTM




                                             Russia / CIS
              Europe
              North America
                                             Israel



                                             China
                                             C

              Japan
                                             Australasia /
                                             Southeast Asia



Page 5




    EdluarTM – recently launched in the USA

         Product characteristics:
            Short-term
            Short term treatment of insomnia
            Sublingual tablet, 5 mg and 10 mg
            zolpidem
            Rapid onset of action

         Status:
            Launched in the USA by partner Meda in
                                 yp
            mid-August
            Priced in line with branded competitors
            Orexo will receive royalty and potentially
            further sales milestones

  Page 6




                                                              3
Sales Joint Venture with ProStrakan



                                                           Abstral ®                 Rectogesic ®
                                                           Breakthrough              Pain associated
                                                           cancer pain               with chronic anal
                                                                                     fissure
     Sales company
                         g
     Focused in Nordic region
     50:50 ownership
     Revenue Generating                                    Tostrex ®                 Dridol®
                                                           Testosterone gel          Post-operative
                                                           for male                  nausea and vomiting
                                                           hypogonadism
Page 7




Profitable Orexo Diagnostics subsidiary:
              Products for diagnosis of the ulcer-
              causing bacterium Helicobacter pylori
              Sales of SEK 21.5 million in H1 2009
              Focus on continuing growth and profit
                                                                              Heliprobe® System
     Sales development
     SEKm
         35

         30                               28,6
                                   24,9
         25                                       21,5
         20                 17,3
         15

         10
                     5,1
         5     3,4

         0                                                                    Diabact® UBT
              2004   2005   2006   2007   2008   H1 2009



Page 8




                                                                                                           4
Orexo - improved financial result
                                                           H1            H1                  FY
    SEKm
                                                         2009          2008                2008

    Net re en es
        revenues                                        144.6
                                                        144 6          80.2
                                                                       80 2                233.3
                                                                                           233 3

    Operating costs                                    -167.7         -166.8             -328.4

    Operating profit/loss                                -35.3         -95.5              -112.5



     Total operating costs in 2009 are expected to be SEK 300 – 320m

     Following recently-announced efficiency measures and developments
     in the project portfolio, annual costs are expected to decrease by SEK
     100m in 2010 compared with 2009

     SEK 137.2m in cash reported at end of H1 2009
 Page 9




  Product portfolio with strong partnerships
             Abstral™                                                       OX17


          Indication:    Breakthrough cancer pain                       Indication:   Not disclosed
          Partners:      ProStrakan, Kyowa Hakko Kirin                  Stage:        Phase II/III
                         Gedeon Richter, Hospira, Novamed, Neopharm


             Edluar™                                                       OX-MPI


          Indication:    Insomnia                                       Indication:   Pain & inflammation
          Stage:         Launched in the USA                            Stage:        Preclinical
          Partners:      Meda



             Diabact®                                                      OX-NLA
            Heliprobe®       (Subsidiary)

          Indication:    Diagnostic for Helicobacter pylori             Indication: Rhinitis
          Partners:      Distribution partners across Europe,           Stage:      Phase III ready
                         CIS and Middle East



Page 10




                                                                                                            5
Further partnership opportunities

                   OX-AAF                                  OX914


               Indication:   Asthma & COPD             Indication: COPD / Asthma
               Stage:        Preclinical               Stage:      Phase II




                   OX-PKX                                  OX219


               Stage:        Various consumer health
                             and Rx products            Indication: Opioid Addiction
               Objective:
               Obj i         Big h
                             Bi pharma partners         Stage:      Ready for clinical phase
                                                        Objective: Own sales, but license available for Japan




Page 11




     OX17 – innovative new formulation

          Combination of a H2-blocker and a
          PPI

          Original formulation targeted GERD

          Fast onset and sustained effect

          Global market: USD 28bn(1)

          License agreement with Novartis
          signed i 2009
           i   d in




Page 12    1) IMS Health
12




                                                                                                                6
OX-MPI – NCE against inflammatory pain

  Product description         Selective PGE2 inhibitor
                              Targeting low-side-effect need in inflammatory pain
                                   g    g                                   yp
                              Filling the gap in the market following the COX2 limitations


  Market potential            Global market: ~USD 10bn(1)

  Competitive landscape       Replacement of NSAIDS/COX2 inhibitors


  Competitive advantage       Powerful relief from inflammatory pain
                              Good safety profile
                              No CV/GI side effects

  Development status          Pre-clinical phase
                              Partnered with Boehringer Ingelheim

Page 13   1) IMS Health




  OX-NLA - Rhinitis

  Product description               Liposome formulation - Nasal cetirizine for rhinitis


  Market potential                  Global market USD ~10bn(1)

  Competitive landscape             Direct competitor to Azelastine Nasal Spray
                                    (US - MedPointe (also Meda))
                                    Azelastine compliance hampered by taste


  Competitive advantage             Good clinical efficacy
                                    Lower sedation than cetirizine tablet

  Development status                Phase II complete, Phase III ready
                                    Worldwide partnership with Meda
                                     – Double-digit royalty plus potential sales milestones
                                     – USD 15m milestone when approved by FDA

Page 14       1) IMS Health




                                                                                              7
OX-AAF – Multiple product opportunities

Product description                      Selective inhibitors of valid targets in arachidonic acid cascade
                                         Targets for asthma, COPD, inflammation
                                            g
                                         Lead program OX-CLI is in pre-clinical stage


Market potential                         Global market: ~USD 25bn(1)

Competitive landscape                    Singulair, Accolate, Advair , but improved therapeutic action


Competitive advantage                    Single targets affecting multiple pathways at optimum points
                                         Excellent in-vitro efficacy
                                         Potential tissue-remodelling prevention
                                         Excellent side-effect profiles
Development status                       Pre-clinical phase
                                         Partnering discussions ongoing with Big Pharma partners
Page 15   1) IMS Health




OX219 – opportunity for in-house commercialization

          Opioid-addiction therapy drug, containing
          buprenorphine and naloxone
            p     p
          Superior to Suboxone™ (Reckitt-Benckiser1)),
          with significant advantages:
                – Taste
                – Speed of dissolution
                – Easier compliance
                – Lower abuse potential
                – Dosage forms

          Suboxone™ sales are USD ~800m globally
          Currently reformulating product for regulatory
          route

      1) Sold by Schering Plough in EU

Page 16




                                                                                                             8
Acquisition of PharmaKodex

      Acquisition of PharmaKodex added 4                Accustar powder sachet
      technologies in line with Orexo’s
                                Orexo s
      strategy to develop superior,
      differentiated drugs using effective new
      and existing drug molecules


      Both Rx and Consumer products under
                                                       Pandermal applicators
      discussion – Rx deal numbers are
      bigger, but Consumer is lower risk &
      faster to revenue




Page 17




     Orexo – covered by 6 equity research houses

           Handelsbanken                     Nordea

             Erik Hultgård                       Patrik Ling
             Accumulate                          Buy

           ABG Sundal Collier                SEB Enskilda

             Alexander Lindström                 Gustaf Vahlne
             Buy                                 Buy

           Carnegie                          Redeye

             Camilla Oxhamre                     Klas Palin
             Neutral                             Buy



18




                                                                                 9
Share price development since January 2008

                      Licensing        AbstralTM           ProStrakan –          Agreement in                               Positive phase III     Global agreement
                                                                                                    FDA approval
                      deal with        approved in         new partner           China and                                  data for Abstral       with Novartis for
    SEK(1)                                                                                          of EdluarTM
                      Meda             Europe              in the US             Israel                                     in Japan               OX17
      70

      60
                                                                                                                                                   Orexo -16%
      50

      40                                                                                                                                         OMX-biotech -16%

      30
                                                                                                                                                  OMXS-PI -19%
      20

      10

          0
                     feb




                                                                                              feb
              jan



                           mar

                                 apr



                                             jun



                                                         aug

                                                               sep




                                                                                                    mar
                                                                     okt




                                                                                        jan




                                                                                                          apr



                                                                                                                      jun



                                                                                                                                     aug

                                                                                                                                           sep
                                       maj



                                                   jul




                                                                           nov

                                                                                  dec




                                                                                                                maj



                                                                                                                               jul
          1) Index rebased to Orexo’s share price as of Jan 1, 2008
          Share price development until September 8, 2009
Page 19




  Potential news flow in 2009
              Filing of Abstral with FDA in USA

              Definitive license agreement with OX17 Partner

              Launch of Abstral on additional European markets

              First formulation partnership with Big Pharma

              Launch of Edluar in the USA

              OX-PKX product license agreement(s)

              Partnership deal for OX-AAF program

              Next milestone in OX-MPI partnership with BI

              Partnership agreement on OX914


                    Revenue growth expected from AbstralTM and EdluarTM
Page 20




                                                                                                                                                                       10
Where is Orexo going?
          Aim is to be a profitable specialty pharma company with
          reputation for innovation and delivery

          Plan to take 2 products into the clinic each year

          Start selecting products for own account to capture margin

          Find appropriate license partners for other programs

          Looking to expand sales activity with own products

          Find appropriate strategic partners for growth – new
          products, new acquisitions that cement the strategy



            Revenue growth expected from AbstralTM and EdluarTM
Page 21




                                        Thank you




                                   www.orexo.com

Page 22




                                                                       11

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Orexo Healthcare Seminar Highlights Drug Delivery Platform and Profitability Goals

  • 1. Orexo Nordea Healthcare Seminar 15-16 September, 2009 Page 1 Orexo – building for profitability Two main platforms – Drug Delivery and Discovery Strong focus on innovative d S f i i drug d development l 2 products launched on major markets within the last 12 months - AbstralTM (EU) and EdluarTM (USA) Strong pipeline delivering real value for the long term Revenue-generating partnerships with: – ProStrakan – Kyowa Kirin – Meda – Boehringer Ingelheim – Novartis Listed on NASDAQ-OMX Stockholm: Ticker: ORX; Market capitalization SEK 936m(1) 1) Market capitalization as of September 9, 2009 Page 2 1
  • 2. Strong position to capture value Launched Partnered Partnered Owned Launched Development Diagnostic Development Discovery & Discovery Products Products Programs Programs Programs Abstral™ Kibion OX17 OX-MPI OX219 Edluar™ OX-NLA OX914* Joint Venture OX-PKX* OX-AAF* * In Partnering discussions Page 3 AbstralTM – showing strong growth in EU Breakthrough cancer pain attacks Sublingual fentanyl tablet for the (millions / year(1)) management of breakthrough cancer p g g pain Fast acting and convenient administration Partnered in Europe, North America and Japan Launched in UK, Germany, France and Sweden – planned launch in Spain in H2 2009 NDA filed in the US by partner ProStrakan Page 4 1) Source: Datamonitor; Europe includes the five largest markets 2
  • 3. Partnering agreements worldwide - to capture the full potential of AbstralTM Russia / CIS Europe North America Israel China C Japan Australasia / Southeast Asia Page 5 EdluarTM – recently launched in the USA Product characteristics: Short-term Short term treatment of insomnia Sublingual tablet, 5 mg and 10 mg zolpidem Rapid onset of action Status: Launched in the USA by partner Meda in yp mid-August Priced in line with branded competitors Orexo will receive royalty and potentially further sales milestones Page 6 3
  • 4. Sales Joint Venture with ProStrakan Abstral ® Rectogesic ® Breakthrough Pain associated cancer pain with chronic anal fissure Sales company g Focused in Nordic region 50:50 ownership Revenue Generating Tostrex ® Dridol® Testosterone gel Post-operative for male nausea and vomiting hypogonadism Page 7 Profitable Orexo Diagnostics subsidiary: Products for diagnosis of the ulcer- causing bacterium Helicobacter pylori Sales of SEK 21.5 million in H1 2009 Focus on continuing growth and profit Heliprobe® System Sales development SEKm 35 30 28,6 24,9 25 21,5 20 17,3 15 10 5,1 5 3,4 0 Diabact® UBT 2004 2005 2006 2007 2008 H1 2009 Page 8 4
  • 5. Orexo - improved financial result H1 H1 FY SEKm 2009 2008 2008 Net re en es revenues 144.6 144 6 80.2 80 2 233.3 233 3 Operating costs -167.7 -166.8 -328.4 Operating profit/loss -35.3 -95.5 -112.5 Total operating costs in 2009 are expected to be SEK 300 – 320m Following recently-announced efficiency measures and developments in the project portfolio, annual costs are expected to decrease by SEK 100m in 2010 compared with 2009 SEK 137.2m in cash reported at end of H1 2009 Page 9 Product portfolio with strong partnerships Abstral™ OX17 Indication: Breakthrough cancer pain Indication: Not disclosed Partners: ProStrakan, Kyowa Hakko Kirin Stage: Phase II/III Gedeon Richter, Hospira, Novamed, Neopharm Edluar™ OX-MPI Indication: Insomnia Indication: Pain & inflammation Stage: Launched in the USA Stage: Preclinical Partners: Meda Diabact® OX-NLA Heliprobe® (Subsidiary) Indication: Diagnostic for Helicobacter pylori Indication: Rhinitis Partners: Distribution partners across Europe, Stage: Phase III ready CIS and Middle East Page 10 5
  • 6. Further partnership opportunities OX-AAF OX914 Indication: Asthma & COPD Indication: COPD / Asthma Stage: Preclinical Stage: Phase II OX-PKX OX219 Stage: Various consumer health and Rx products Indication: Opioid Addiction Objective: Obj i Big h Bi pharma partners Stage: Ready for clinical phase Objective: Own sales, but license available for Japan Page 11 OX17 – innovative new formulation Combination of a H2-blocker and a PPI Original formulation targeted GERD Fast onset and sustained effect Global market: USD 28bn(1) License agreement with Novartis signed i 2009 i d in Page 12 1) IMS Health 12 6
  • 7. OX-MPI – NCE against inflammatory pain Product description Selective PGE2 inhibitor Targeting low-side-effect need in inflammatory pain g g yp Filling the gap in the market following the COX2 limitations Market potential Global market: ~USD 10bn(1) Competitive landscape Replacement of NSAIDS/COX2 inhibitors Competitive advantage Powerful relief from inflammatory pain Good safety profile No CV/GI side effects Development status Pre-clinical phase Partnered with Boehringer Ingelheim Page 13 1) IMS Health OX-NLA - Rhinitis Product description Liposome formulation - Nasal cetirizine for rhinitis Market potential Global market USD ~10bn(1) Competitive landscape Direct competitor to Azelastine Nasal Spray (US - MedPointe (also Meda)) Azelastine compliance hampered by taste Competitive advantage Good clinical efficacy Lower sedation than cetirizine tablet Development status Phase II complete, Phase III ready Worldwide partnership with Meda – Double-digit royalty plus potential sales milestones – USD 15m milestone when approved by FDA Page 14 1) IMS Health 7
  • 8. OX-AAF – Multiple product opportunities Product description Selective inhibitors of valid targets in arachidonic acid cascade Targets for asthma, COPD, inflammation g Lead program OX-CLI is in pre-clinical stage Market potential Global market: ~USD 25bn(1) Competitive landscape Singulair, Accolate, Advair , but improved therapeutic action Competitive advantage Single targets affecting multiple pathways at optimum points Excellent in-vitro efficacy Potential tissue-remodelling prevention Excellent side-effect profiles Development status Pre-clinical phase Partnering discussions ongoing with Big Pharma partners Page 15 1) IMS Health OX219 – opportunity for in-house commercialization Opioid-addiction therapy drug, containing buprenorphine and naloxone p p Superior to Suboxone™ (Reckitt-Benckiser1)), with significant advantages: – Taste – Speed of dissolution – Easier compliance – Lower abuse potential – Dosage forms Suboxone™ sales are USD ~800m globally Currently reformulating product for regulatory route 1) Sold by Schering Plough in EU Page 16 8
  • 9. Acquisition of PharmaKodex Acquisition of PharmaKodex added 4 Accustar powder sachet technologies in line with Orexo’s Orexo s strategy to develop superior, differentiated drugs using effective new and existing drug molecules Both Rx and Consumer products under Pandermal applicators discussion – Rx deal numbers are bigger, but Consumer is lower risk & faster to revenue Page 17 Orexo – covered by 6 equity research houses Handelsbanken Nordea Erik Hultgård Patrik Ling Accumulate Buy ABG Sundal Collier SEB Enskilda Alexander Lindström Gustaf Vahlne Buy Buy Carnegie Redeye Camilla Oxhamre Klas Palin Neutral Buy 18 9
  • 10. Share price development since January 2008 Licensing AbstralTM ProStrakan – Agreement in Positive phase III Global agreement FDA approval deal with approved in new partner China and data for Abstral with Novartis for SEK(1) of EdluarTM Meda Europe in the US Israel in Japan OX17 70 60 Orexo -16% 50 40 OMX-biotech -16% 30 OMXS-PI -19% 20 10 0 feb feb jan mar apr jun aug sep mar okt jan apr jun aug sep maj jul nov dec maj jul 1) Index rebased to Orexo’s share price as of Jan 1, 2008 Share price development until September 8, 2009 Page 19 Potential news flow in 2009 Filing of Abstral with FDA in USA Definitive license agreement with OX17 Partner Launch of Abstral on additional European markets First formulation partnership with Big Pharma Launch of Edluar in the USA OX-PKX product license agreement(s) Partnership deal for OX-AAF program Next milestone in OX-MPI partnership with BI Partnership agreement on OX914 Revenue growth expected from AbstralTM and EdluarTM Page 20 10
  • 11. Where is Orexo going? Aim is to be a profitable specialty pharma company with reputation for innovation and delivery Plan to take 2 products into the clinic each year Start selecting products for own account to capture margin Find appropriate license partners for other programs Looking to expand sales activity with own products Find appropriate strategic partners for growth – new products, new acquisitions that cement the strategy Revenue growth expected from AbstralTM and EdluarTM Page 21 Thank you www.orexo.com Page 22 11