OREXO AB SPECIALTY PHARMA FOCUSING ON OPIOID DEPENDENCE AND PAIN TREATMENT NORDIC LIFE SCIENCE CONFERENCE

Transcription

1 OREXO AB SPECIALTY PHARMA FOCUSING ON OPIOID DEPENDENCE AND PAIN TREATMENT NORDIC LIFE SCIENCE CONFERENCE NASDAQ STOCKHOLM: ORX US OTC MARKET: ORXOY (ADR) APRIL 27 TH, 2015

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. 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. 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 AGENDA Introduction to Orexo Zubsolv launch progress Financials Summary

4 OREXO IN BRIEF SNAPSHOT OF OREXO A specialty pharmaceutical company with a risk-mitigating business model Orexo is a specialty pharmaceutical company with commercial operations in the United States and R&D in Sweden Orexo develops improved treatments by focusing on perfecting methods of drug delivery This is achieved by combining proven pharmaceutical substances with Orexo s patented proprietary sublingual (under the tongue) technology Faster, and at a lower risk and cost, than traditional pharmaceutical development which includes development of new chemical substances To date Orexo has developed four products of which Zubsolv is the most recent Zubsolv is a treatment for opioid dependence and was launched in the US in September 2013 targeting a growing $1.9bn (gross) market Zubsolv gained 2% market share in less than 6 months after launch and today has close more than 6% tablet share The continued development of Zubsolv is currently the Group s main focus Other products include e.g. Abstral and Edluar, both of which comprise sublingual treatments which have been out licensed and generate royalties to Orexo on a global scale Abstral royalties amounted to SEK 246m in 2013 y/y growth of 40% Edluar royalties amounted to SEK 9m in 2013 y/y growth of 38% The company is listed on Nasdaq Stockholm mid-cap Main shareholders are Novo A/S (the main shareholder of Novo Nordisk and Novozymes) owning 28.1% and HealthCap owning 11.7% of Orexo s shares. Market cap of SEK 3.5bn as at April 24, 2015 ADRs listed on US OTCQX (ORXOY) The market for treatment for opioid dependence Chronic Pain (>100M Americans experience chronic pain) Chronic Opioid Use (50M Americans are chronic opioid users) Opioid Dependent (5M develop dependence) Diagnosed opioid dependent (2M) Treated (0.8M) bup/nal (0.5M) Only 2m of opioid dependents are diagnosed and only 0.8m (20%) of opioid dependents receive treatment 0.5m are treated with buprenorphine/naloxone catering for a $1.9bn (gross) market

5 OREXO IN BRIEF PRODUCT HIGHLIGHTS The Orexo product platform comprises several different products with strong growth and high gross margins Zubsolv: patented treatment of opioid dependence Fast-dissolving sublingual tablet with favorable profile Launched in US September, 2013 first differentiated product to compete in $2bn (gross) Suboxone market Abstral: Patented breakthrough cancer pain relief Marketed in US, Europe and Japan through licensing agreements generating double-digit royalties o European agreement ensured fixed royalties of 55M in three installments Market leader in Europe, strong growth in the US and Japan Edluar: Insomnia treatment Marketed in the US and EU through licensing agreements with Meda generating double-digit royalties Heliprobe System, Diabact and IRIS Ulcer bacteria diagnosis Sold in more than 60 countries under subsidiary name Kibion self-sustaining business Several drugs in pipeline. Considerable asset in OX51 after promising phase-ii results showing significant dose response with no safety concerns for dose range studied week average tablets sold SEKm SEKm SEKm Royalty revenue (incl fixed payments ) Royalty revenue 2,3 1,3 2,4 6,3 8, Revenues '05 '06 '07 '08 '09 '10 '11 '12 '13

6 AGENDA Introduction to Orexo AB Zubsolv launch progress Financials Summary

7 OPIOID ADDICTION HAS GROWN INTO AN EPIDEMIC IN THE US Patients are struggling to fight against the Opioid Addiction Monster 46 people a day lose the battle...society thinks heroin & hardcore...but it s pain meds & the accidental addict

8 MARKET GROWTH OF 13 PERCENT IN NEW PRESCRIPTIONS PROJECTED TO CONTINUE IN 2015 Annual NRx growth Positive Outlook driven by US government 000 NRx % 13.4 % 0 MAT Q MAT Q MAT Q Note: MAT = Moving annual total, 12 months, TRx =Total prescriptions Source: Orexo analysis, Redeye - Bloomberg, WK weekly sales data PAGE 8.

9 TRx Market Share MARKET SHARE IN TABLETS (1) EXCEED 6 PERCENT IN Q1 TRx share lagging tablet share due script size above market average Zubsolv Market Share (4 week average, %) 6,0% TRx Tablet Share 2014 Δ ,5% TRx Share Q1 Δ Q4 +0.4% 6,0% 5,0% 4,0% 3,0% 2,0% 5,0% 4,0% 3,0% 2,0% TRx Tablet Market Share 1,0% 1,0% 0,0% 0,0% (1) Market share in terms of Orexo share of the total market quantity of tablets, film and patch of Bup/Nal Source: Orexo analysis, Redeye - Bloomberg, WK weekly sales data PAGE 9.

10 Tablets Demand DEMAND FOR ZUBSOLV INCREASED 21% DURING Q1 > patients treated with Zubsolv every day Zubsolv tablet prescription volume (rolling 4 weeks) Comments Average weekly sales 2014 Δ 6X from W1-W52 Q2 Q3 Q4 Q1 Δ Q4, 21% Market share gain driven by Commercial execution with 50 FTE field force from launch expanded continuously as market access improves Exclusive contract with United Health Group (July 1, 14), WellCare (Nov 1, 14) and some small regional plans Only brand reimbursed by CVS Caremark (Jan 1, 14) 0 Q1 * Until December 19, 2014 Note: Weekly script data is based on extrapolation and is associated with uncertainties in the launch phase of new pharmaceuticals Source: Orexo analysis, Redeye, WK weekly data, Q1 15 week 1-week 13, Q4 14 week 40-week 52 PAGE 10.

11 NUMBER OF UNIQUE PRESCRIBERS HAS GROWN TO >8,000 WITH ~4,800 WRITING DURING THE LAST 4 WEEKS Total number of unique prescribers (Launch to date) Prescribers in last 4 weeks and per week , Average Zubsolv share in prescribers in last 4 weeks is 11% 4, , Average Zubsolv share in weekly prescribers is 13% Source: Orexo analysis, IMS PA (ending )

12 CONTINUED FOCUS TO DRIVE SHARE THROUGH COMMERCIAL INVESTMENT AND R&D Commercial development Clinical development Controlled expansion of field force with improved market access Continue to improve market access Drive attention through non-traditional marketing, Results from 006/ISTART, 007/Induction, 008 study, ensure access to rich data set in opioid dependence Continue investment in clinical researh planned for 2015 Pharmaceutical development Expansion of dosage range Launch of 8.6mg tablet in March Launch of 2.9mg and 11.4mg tablets in H2

13 SIGNIFICANT R&D ACHIEVEMENTS DURING 2014 ARE UNIQUE AND ARE THE FOUNDATION FOR COMMERCIAL EXECUTION Recap of 2014 Clinical development 2015 Clinical Completed ISTART study with 758 patients Zubsolv as effective as Suboxone Film Zubsolv Preferred Zubsolv with similar safety profile Completed induction clinical study and submitted application for label expansion expected Q3, 2015 Zubsolv is preferred by more than 70% of patients Overall Preference 70% preferred Zubsolv ISTART Clinical Study 30% preferred Suboxone 1 Taste: 78% vs. 22% Ease of Administration: 72% vs. 28% Clinical Finalization of Study 008 (longterm treatment experience with Zubsolv ) Zubsolv well tolerated and safe <1% failure rate due to treatment Postive impact on work productivity (employment, hours worked) 1 Suboxone is a registered trademark of Indivior PLC. Source: STUDY 006/ISTART, OX , OX , data on file with Orexo AB PAGE 13.

14 ESTABLISHING THE BROADEST DOSE RANGE IS A CORE ELEMENT OF OREXO S STRATEGY Broadest dose range in the market Patients on this DD 1 23% 42% 7% 21% 5% 2% Generics 11.4mg Approved mg Launched 12mg 6.3mg - 5.7mg Launched 8mg 4.2mg 8mg 2.9mg Filed 4mg 2.1mg - 1.4mg Launched 2mg - 2mg Adding value to treatment: Enable intended once daily use as labelled by the FDA and supported by science Today, patients get several tablets per day leading to multiple daily dosages and risk diversion to unintended use 1 Daily Dose Source: Orexo analysis

15 AGENDA Introduction to Orexo AB Zubsolv launch progress Financials Summary

16 HEADLINES 2015 FINANCIALS Total Net Revenues for Q1 amounted to MSEK up 46% vs prior year Zubsolv revenues ended at MSEK up 19% from Q4, o Demand up by more than 21% (1). o Positive revenue contribution from strong US dollar. o Negative revenue contribution from reduced wholesaler inventories and slightly higher deductions from gross to net revenue. EBIT for Q ended at MSEK -8.1 and EBITDA at MSEK -5.1 Operating costs expected to increase during 2015 from investment in expanded field force and new clinical trial. Positive cash flow of MSEK 6.5 Cash balance of MSEK Planned inventory build and major clinical trials completed. Future cash-flow highly dependent on future investment decisions. PAGE 16. 1) Orexo analysis, Redeye - Bloomberg, WK weekly sales data Week and Week

17 AGENDA Introduction to Orexo AB Zubsolv launch progress Financials Summary

18 TOP PRIORITIES YEAR 2015 The top priority is to ensure continued successful growth of Zubsolv in the U.S. USA I Zubsolv Commercialization Grow share in non-exclusive segments Continue improvement in market access Chronic Pain (>100M) Chronic Opioid Use (50M) Opioid Dependent (5M) Diagnosed opioid dependent (2M) Treated w/ ORT (0.8M) bup/ nal (0.5M) II III Extend the playing field Induction label Explore opportunities to broaden indication Continued product development Drive market share in core segment Broadest dose range Richest dataset from clinical trials Ex-US IV Take Zubsolv global Pain V OX51 (phase III ready alfentanil compound for procedure-induced pain) PAGE 18.

19 SEVERAL EXCITING MILESTONES DURING Q1 Q2 Q3 Q4 and beyond Launch of 8,6mg Zubsolv Fourth patent for Zubsolv granted Expire 2032 Results of OX study Safety Retention Patient productivity General efficacy Approval of Induction label by the FDA anticipated Launch of new dosage Partnership agreement for Zubsolv outside the US and/or OX-51 Initiation of new clinical study with Zubsolv Approval and launch of new dosage of Zubsolv Additional progress in Market Access

20 TO CONCLUDE Zubsolv has in 1,5 years gained >6% market share with continued sales growth and market share capture in Q1 - Market access wins significant driver during Continuous increase in number of consistent prescribers Finalization of the broad clinical program initiated in 2013 with the launch of Zubsolv, with positive results - Zubsolv is effective, well tolerated and preferred over Suboxone Film by the participating patients - Enable filing of application for Induction label Successful pharmaceutical development with the broadest dosage range in the disease area available in H PAGE 20.

21 Q&A Analyst coverage Financial institute Analyst Available online Redeye Klas Palin Edison Group Philippa Gardner Erik Penser Johan Löchen Carnegie ABG Danske Bank Guggenheim Nordea Pareto Securities Kristofer Liljeberg Sten Gustafsson Mattias Häggblom Louise Chen Erik Hultgård Yilmaz Mahshid

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