TRANSITION TO A COMMERCIAL AND PROFITABLE PHARMACEUTICAL COMPANY CONTINUES. Presenting at Småbolagsdagen June 10, 2013

Transcription

1 TRANSITION TO A COMMERCIAL AND PROFITABLE PHARMACEUTICAL COMPANY CONTINUES Presenting at Småbolagsdagen June 10, 2013

2 LEGAL DISCLAIMER This presentation, which is personal to the recipient, has been prepared and produced by Orexo AB (publ) ( Orexo ) solely for the benefit of investment analysis and may not be used for any purpose other than assessment of investments concerning Orexo. Unless otherwise stated, Orexo is the source for all data contained in this presentation. Such data is provided as at the date of this presentation and is subject to change without notice. This presentation is strictly confidential and is being furnished to you solely for your information. It may not be reproduced, redistributed, passed on or published, in whole or in part, to any other person for any other purpose. This presentation does not constitute or form part of, and should not be construed as, an offer or invitation for the sale of or the subscription of, or a solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any offer, contract, commitment or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of Orexo. Neither this presentation nor any copy of it may be taken, transmitted into or distributed in the United States, the United Kingdom, Canada, Australia or Japan except by or on the express instructions of Orexo. The distribution of this presentation in other jurisdictions may also be restricted by law and persons into whose possession this presentation comes should inform themselves about and observe any such restrictions. The shares of Orexo have not been registered under the U.S. Securities Act of 1933, as amended (the Securities Act"), and may not be offered or sold in the United States (as such term is defined in Regulation S under the Securities Act) except pursuant to an exemption from, or a transaction not subject to, the registration requirements of the Securities Act or unless registered under the Securities Act. This presentation is directed only at persons who: (i) are outside the United Kingdom; or (ii) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (financial promotion) order 2005 ( the order ); or (iii) are persons to whom it can otherwise lawfully be distributed (all such persons together being referred to as relevant persons ). This presentation must not be acted on, or relied on by, persons who are not relevant persons. The information in this presentation has not been independently verified. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained herein. None of Orexo, any of its shareholders, or any of their respective subsidiary undertakings or affiliates or any of such person s directors, officers or employees, advisers or other representatives, accepts any liability whatsoever (whether in negligence or otherwise) arising, directly or indirectly, from the use of this presentation or otherwise arising in connection therewith. This presentation includes forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance, achievements or industry results to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and Orexo expressly disclaim any obligation or undertaking to release any update of, or revisions to, any forward-looking statements in this presentation as a result of any change in our expectations or any change in events, conditions or circumstances on which these forward-looking statements are based. This presentation is not a prospectus in accordance with the Swedish Financial Instruments Trading Act (Sw. lagen (1991:981) om handel med finansiella instrument) or any other Swedish laws or regulations. Neither the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) nor any other Swedish regulatory body has examined, approved or registered this presentation. Page 2

3 OREXO COMPANY OVERVIEW PROVEN DEVELOPMENT TRACK RECORD BASED ON FORMULATION STRATEGY US Product. Proprietary US commercial product in 2013 FORMULATION TECHNOLOGY (Sublingual Delivery) Zubsolv for opioid dependence Platform & Pipeline. Sublingual formulation technologies driving products and pipeline PROPRIETARY PRODUCTS PIPELINE Zubsolv: Opioid dependence OX51: Procedure-induced pain OX27: BTCP Revenues. Portfolio of revenue generating US/EU partnered products Manufacturing. In-house GMP facility approved for controlled substances PARTNERED PRODUCTS PIPELINE Abstral: BTCP (Kyowa ex US, Galena BioPharma US) Edluar : Insomnia (Meda) OX-CLI: Astra Zeneca 1 OX-MPI: Boehringer Ingelheim 1 1) Not based on drug delivery technology Page 3

4 THE START OF A NEW COMMERCIAL CHAPTER IN THE OREXO EVOLUTION 2013 has started in a fast pace to continue focusing the business New CEO appointed in February Agreement with Astra Zeneca on OX-CLI Agreement with Galena Biopharma on Abstral, worth $15M (SEK 97,5M) in one time payments and additional royalty expected Successful Zubsolv launch, the primary objective of 2013 Target date for approval of Zubsolv set for early July, 2013 Significant clinical programs initiated to gain differentiation Establish commercial infrastructure in the US Launch anticipated in September 2013 Other projects and products to continue strengthen the Orexo base Abstral approval in Japan OX51 results from a dose-finding phase II study expected Edluar launch in Europe Page 4

5 ZUBSOLV OREXO LEAD VALUE DRIVER

6 SIGNIFICANT MARKET FOR OPIOID DEPENDENCE 44% 11% ~40% Established ~35-45% Pharma Focus Chronic Pain 1 N=109 MM Rx Opioids for Chronic Pain 2 N=~48 MM Develop Dependence 3 N=5 MM Diagnosed Dependent 4,5 N=2 MM Treated 6 N= K Increased ambition to control opioid use but lack of good alternatives Opioids are highly addictive with 11% developing dependence Majority of opioid users are unaware of own dependence and/or believe they can wean off by themselves Lack of prescribing physicians and even if referred few dependents receive treatment ~50% Suboxone 7 ~3M patients have been treated with Suboxone N=400 K Zubsolv market-entry focus Source: Trinity Market Reserach, October ) Committee on Advancing Pain, Research and Education (N and %) 2) Clark, J.D., J Pain Symptom Manage (2002) (%) 3) NSDUH (N) 4) Peer, K, Drug and Alcohol Dependence (2012) (%) 5) Healthcare for Communities Survey (%) 6) NSDUH; Trinity experienced based on Rx data (N); Decision Resources (%) 7) Presentation at SAMHSA buprenorphine meeting (N) Page 6

7 CHANGES IN US LEGISLATION WILL DRIVE DEMAND FOR ZUBSOLV IN THE US The Obama administration issued a final rule on Wednesday defining essential health benefits that must be offered by most health insurance plans next year... The federal rule requires insurers to cover treatment of mental illnesses, behavioral disorders, drug addiction. [New York Times, Feb 20 th, 2013] Under healthcare reform, millions of people will become eligible for insurance coverage starting in January. The number of people seeking addiction treatment could double [Associated Press, April 16 th, 2013] "There is no illness currently being treated that will be more affected by the Affordable Care Act than addiction," Tom McLellan, CEO of the nonprofit Treatment Research Institute, [Associated Press, April 16 th, 2013] Page 7

8 SUBOXONE IS A US BLOCKBUSTER THAT CONTINUES TO DEMONSTRATE DOUBLE-DIGIT GROWTH Suboxone Tablet Launched 2003 US SALES (IN MILLIONS OF USD) Film approved in August % +38% Marketed by Reckitt Benckiser Sales of $1.5 billion in 2012 Sales growth of 21% in Q1-Q ,4% TRx growth Growth drivers: Growing number of sufferers Increasing proportion seeking therapy Price increases Sources: IMS, RB Annual report, Credit Suisse Reports on RB Page 8

9 ZUBSOLV IS WELL POSITIONED TO REPEAT SUCCESSFUL INTRODUCTION OF SUBOXONE FILM BUP/NLX market evolution Suboxone Tablet Suboxone Film Zubsolv First in class buprenorphinenaloxone combination product Replacing stigmatized abuse clinics enabled broader population to be treated for opioid dependency Improved formulation, dissolved faster and improved taste masking Further improvement of dissolve time, taste masking and mouth feel over Tablet Preferred by 9 out of 10 participants in an acceptability study compared to the Suboxone Film Page 9

10 STUDY COMPARING WITH SUBOXONE FILM SHOWS 89% WOULD CHOOSE ZUBSOLV DRIVEN BY TASTE, ADMINISTRATION AND AFTERTASTE OVERALL PREFERENCE (WHICH TREATMENT WOULD YOU CHOOSE?) Suboxone Film 89% Zubsolv TM Taste (WHICH TASTE DO YOU PREFER?) Suboxone Film Ease of administration (WHICH TREATMENT IS MOST EASY TO ADMINISTER?) Suboxone Film Unpleasant aftertaste (SHARE OF PARTICIPANTS WITH NO UNPLEASANT AFTER TASTE?) 96% 89% Zubsolv TM Zubsolv TM 57% 7% p < p < Zubsolv (OX219) Suboxone Page 10

11 FOCUS OF ZUBSOLV IS TO BECOME THE PREFERRED CHOICE FOR ALL PATIENTS Payer At least equal payer coverage for Zubsolv Price competitive Prescriber Aware of Zubsolv superior product features and make is available for patients FDA Comparable label and REMS with Suboxone Zubsolv the patients choice Patients Improved support program and equal financial support to Suboxone Page 11

12 ABSTRAL TREATMENT OF BREAKTHROUGH CANCER PAIN

13 ABSTRAL FOR BREAKTHROUGH CANCER PAIN (BTCP) FAST-ACTING SUBLINGUAL TABLET FORMULATION OF FENTANYL CITRATE FAST-ACTING Sublingual TABLET formulation of fentanyl citrate Launched in EU in 2008 Launched in US in 2011 Orexo acquired back rights to the US in June 2012 Approval and launch anticipated in Japan during 2013 Abstral - the only fast dissolving (in less than a min) sublingual tablets in the category Patients require o o o Fast onset Easy administration Good taste experience Breakthrough pain episode Basal Opioid Page 13

14 RECONFIGURATION OF ABSTRAL RIGHTS GENERATE MORE THAN MSEK 700 IN FIXED PAYMENTS European rights sold to Kyowa Kirin for MSEK 610 US rights sold to Galena Biopharma Inc for MSEK 98 Double digit royalty remain in all geographies except Japan EU for sales exceeding MEUR 42.5 Double digit royalty in ROW and Europe over MEUR 42.5 Fixed payments and milestone Single digit royalty in Japan and approval milestone MUSD 10 upfront and MUSD 5 within first 12 months Double digit royalty 1) Will be reported as revenue in equal monthly amounts over the 12-month period subsequent to when received. 2) Exchange rate of 1.60 USD per GBP. Page 14

15 FINANCIALS

16 NET REVENUES JANUARY-MARCH 2013 MSEK Q Q FY 2012 Abstral -royalties Abstral - milestone payment Edluar -royalties ProStrakan AB joint venture 50 % Kibion Total revenues from launched products Partner-financed R&D-costs Licensing revenue for development projects Other Total Page 16

17 P&L IN SUMMARY Q1 Q1 FY MSEK Net revenues Cost of goods sold Gross Profit Selling expenses Administrative expenses Research & development expenses Other operating income & expenses Operating Costs -102, EBIT Net financial items EBT Tax Net profit/loss EBITDA Page 17

18 FINANCIAL POSITION Cash flow Q1 Q1 FY MSEK Cash flow from operating activities Investment activities -5, Financing activities Cash flow Liquid funds Financing activities 2012 FY include shares bought back amounting to MSEK 53 Abstral royalty (EU) paid in one yearly payment (June) Limited CAPEX in Zubsolv production equipment Page 18

19 SUMMARY: OREXO IS AT A TURNING POINT Preparing the most important launch in the history of Orexo Zubsolv. Entering a commercial space with outstanding macro development Continuous market growth of $1,5 billion market High unmet need >5 million patients Political changes driving growth, addiction treatment an essential health benefit Best-in-class product close to approval with launch expected in September 9 out of 10 would choose Zubsolv compared to market leader Orexo is well positioned to make this happen Commercial team in Sweden and US with strong track-record Financial strength Strategic flexibility to find solution generating most share holder value Page 19

20 Q & A Page 20

21 TRANSITION TO A COMMERCIAL AND PROFITABLE PHARMACEUTICAL COMPANY CONTINUES