Page 1 Orexo Annual General Meeting 2009. An eventful year for Orexo Page 2 Abstral TM – Launched...
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Transcript of Page 1 Orexo Annual General Meeting 2009. An eventful year for Orexo Page 2 Abstral TM – Launched...
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)
Page 5
Page 6
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
Page 7
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:
Page 10
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
Page 21