Jefferies Global Healthcare Conference. June 2015

Transcription

1 Jefferies Global Healthcare Conference June 2015

2 Disclaimer This presentation has been organised by Vectura Group plc (the Company) in order to provide general information on the Company. This material has been prepared solely by the Company and is (i) for your private information, and the Company is not soliciting any action based upon it (ii) not to be construed as an offer to sell or issue or a solicitation of an offer to buy or subscribe for any security and (iii) based upon information that the Company considers reliable. The Company does not represent that the information contained in this material is accurate or complete, and it should not be relied upon as such. No representation, warranty or undertaking, express or implied, is or will be made with respect to the fairness, accuracy or completeness of any of the information or statement of opinion or expectation contained herein or stated in the presentation or any other such information nor shall you be entitled to rely upon it. In furnishing you with this information no obligation is undertaken to provide you with any further information, to update this information nor any other information nor to correct any information contained herein or any omission therefrom. The Company's securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the Act ), and may not be offered or sold in the United States or to U.S. persons unless they have been registered under such Act, or except in compliance with an exemption from or in a transaction not subject to the registration requirements of such Act. This presentation has not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission in the United States or any other regulatory authority in the United States, nor have any of the foregoing authorities passed on the accuracy or adequacy of the information contained in this material. Any representation to the contrary is a criminal offence in the United States. This material does constitute or form part of any offer or invitation to sell or issue or any solicitation of an offer to acquire, purchase or subscribe for the Company s securities in any jurisdiction. No part of this material may be (i) copied, photocopied, or duplicated in any form, by any means, or (ii) redistributed, published, or disclosed by recipients to any other person, in each case without the Company's prior written consent. This material is only being provided to persons who are authorised persons or exempted persons within the meaning of the Financial Services and Markets Act 2000 or any order made thereunder or to other persons of a kind described in Articles 19 and 49 of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005, who are qualified institutional buyers as defined in Rule 144 under the Act or institutional accredited investors as defined in Rule 501 of Regulation D under the Act, or who are otherwise permitted by law to receive it. In relation to information about the price at which securities in the Company have been bought or sold in the past, note that past performance cannot be relied upon as a guide to future performance. In addition, certain statements, beliefs and opinions in this document, are forwardlooking, which reflect the Company s or, as appropriate, the Company s directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. The occurrence of some of the events described in this document and the presentation that will be made, and the achievement of the intended results, are subject to the future occurrence of many events, some or all of which are not predictable or within the Company's control; therefore, actual results may differ materially from those anticipated in any forward looking statements. The Company disclaims any obligation to update these forward looking statements. By attending the presentation to which this document relates or by accepting this document you will be taken to have represented, warranted and undertaken that: (i) you are a person falling within one or more of the categories referred to above as being permitted to receive this presentation (ii) you have read and agree to comply with the contents of this disclaimer notice; and (iii) you will not at any time have any discussion, correspondence or contact concerning the information in this document with any of the directors or employees of the Company, its subsidiaries nor with any of their suppliers, customers, sub contractors or any governmental or regulatory body without the prior written consent of the Company. 2

3 Strong foundations for progress Potential for significant organic revenue growth >20% CAGR to 2022 Including potential milestone income >US$200m Ramp-up and new region launches driving rapid growth in marketed portfolio of partnered products Cutting-edge formulation and device technology Maximising licensing potential Accelerating value creation Strong pipeline targeting a total market size greater than US$25 billion Nine assets to launch through to 2021 Potential to grow and maximise value Track record of delivery Clear strategy in place to achieve corporate goals Our strategy aims to create significant value for all stakeholders through the development and commercialisation of innovative products in airways diseases 3

4 Financial highlights Revenue growth EBITDA 1 progression Adjusted 2 basic EPS growth Driven by 55% increase in royalties + 59% + 212% + 150% 58.0m 16.2m 4.0p (FY 2013/ m) (FY 2013/14 5.2m) (FY 2013/14 1.6p) Royalty income EBITDA 1 progression Adjusted 2 basic EPS growth 0 FY 2012/13 FY 2013/14 FY 2014/15-5 FY 2012/13 FY 2013/14 FY 2014/15-2 FY 2012/13 FY 2013/14 FY 2014/15 EBITDA 1 growth driven by increasing royalty revenues from newly marketed products 4 1 Earnings before investment income, finance gains, tax, depreciation, amortisation, share-based compensation and adjusted for non-recurring expenditure 2 Adjusted basic EPS is calculated using EBITDA and the weighted average number of shares in the period

5 Delivering value from our world class technologies Validated by multiple partnerships Cutting-edge formulation and device technology We innovate FAVORITE smart nebulisation technology Proprietary DPI technologies (blister & reservoir) Formulation expertise (e.g. PowderMax, ParticleMax) Product development expertise 1 We develop 2 Marketed and pipeline assets risk/reward balance Marketed portfolio Codevelopment Partnerships Future self-commercialisation Pipeline products Blue-chip biotech and pharma companies have partnered with us We collaborate 3 Partnerships with top-tier pharma companies such as Novartis, Sandoz, Baxter, Janssen 5

6 New royalty streams target large markets Form basis of sustainable organic growth Estimated total value of drug classes in >$22bn Products in the growth phase of their launch curve Approvals in new geographies New product launches 45% 9% 18% 28% ICS LABA + LAMA LAMA LABA + ICS We have a rapidly growing, diversified revenue stream 1 6 Source: Bloomberg analyst consensus estimates Photos of Seebri Breezhaler and Ultibro Breezhaler courtesy of Novartis AG. Ultibro, Seebri Breezhaler, AirFluSal and Forspiro are registered trade marks of Novartis AG. Anoro Ellipta, Relvar /Breo Ellipta and Incruse Ellipta are registered trade marks of GSK, photos courtesy of GSK

7 Highly valuable and growing pipeline Significant peak sales potential from late-stage products Partnered Wholly owned Generic VR588 Severe inflammatory Airways disease VR942 (UCB) Inflammatory Airways disease (Co-development global) VR475 Severe Adult VR465 (Ablynx) RSV Infection VR647 Paediatric VR096 (Janssen) Anti-inflammatory /COPD VR179 (Grifols) Cystic Fibrosis VR736 (Ventaleon) Severe Influenza VR475 Severe Adult (EU) VR876 (partnered, undisclosed) Pulmonary Hypertension (Europe) VR315 (partnered, undisclosed) VR506 (partnered, undisclosed) VR632 (Sandoz) (EU) NVA237 (Novartis) COPD QVA149 (Novartis) COPD I II III Pre-clinical Phase I Phase II Phase III Full development Filed Nine assets expected to launch by

8 Multiple near term launches Significant potential upside from US royalty streams Partnered Wholly owned Generic VR588 Severe inflammatory Airways disease VR942 (UCB) Inflammatory Airways disease (Co-development global) VR475 Severe Adult VR465 (Ablynx) RSV Infection VR647 Paediatric VR096 (Janssen) Anti-inflammatory /COPD VR179 (Grifols) Cystic Fibrosis VR736 (Ventaleon) Severe Influenza VR475 Severe Adult (EU) VR876 (partnered, undisclosed) Pulmonary Hypertension (Europe) VR315 (partnered, undisclosed) VR506 (partnered, undisclosed) VR632 (Sandoz) (EU) NVA237 (Novartis) COPD QVA149 (Novartis) COPD I II III Pre-clinical Phase I Phase II Phase III Full development Filed Nine assets expected to launch by

9 VR475 EU (FAVOLIR ) Update VR475 refocused to target broader patient population and increase market opportunity Shift from GINA Step 5 OCS-dependent patients to GINA Step 4 and 5 patients Offers potential for an effective, inhaled treatment option Reduce exacerbations in patients Despite being on high doses of ICS plus a second controller (i.e., LABA) Confirmation of scientific approach from CHMP Initiation of clinical trial activities will start imminently Filing anticipated in mid

10 VR647 (SCIPE) Update Budesonide is the only nebulised ICS approved in the US Paediatric label only; age range 1 year-8 years Indicated for the maintenance treatment of asthma Objective is to retain current label/indication for budesonide, with reduced dosing time claim Pre-IND meeting in June to agree US regulatory strategy proposing abbreviated 505(b)(2) programme Continuing to evaluate licensing opportunities to further expedite value return 10

11 Financial outlook FY 2015/16 Revenue Continued growth in royalty revenue Significant development and regulatory milestones expected in H2 15/16 R&D expenditure Increase in clinical trial activities led by VR475 EU Full year guidance at higher end of 40m- 52m range G&A expenses G&A expenses expected to remain in line with FY 14/15 11

12 Upcoming events Progress of Seebri Breezhaler reported quarterly by Novartis Novartis expects US FDA action on NVA237 by Q Progress of Ultibro Breezhaler reported quarterly by Novartis Novartis expects US FDA action on QVA149 by Q AirFluSal Forspiro Launched in 12 European countries (also S. Korea and Mexico); approved in approximately 30 countries Global roll-out continues VR475 EU (FAVOLIR ) Initiation of Phase III clinical trial activities will start imminently and filing anticipated in mid-2018 VR647 (SCIPE) Pre-IND meeting June

13 Strong foundations for progress Potential for significant organic revenue growth Cutting-edge formulation and device technology >20% CAGR to 2022 Including potential milestone income >US$200m Ramp-up and new region launches driving rapid growth in marketed portfolio of partnered products Maximising licensing potential Accelerating value creation Strong pipeline targeting a total market size greater than US$25 billion Nine assets to launch through to 2021 Potential to grow and maximise value Track record of delivery Clear strategy in place to achieve corporate goals Our strategy aims to create significant value for all stakeholders through the development and commercialisation of innovative products in airways diseases 13