Investor Presentation

Transcription

1 Investor Presentation Nuvo Research Inc. September 14, 2015 TSX: NRI

2 Safe Harbour Certain information to be discussed during this corporate update contains forward-looking statements within the meaning of applicable securities laws including, among others, statements concerning the Company s 2015 objectives, the Company s strategies to achieve those objectives, as well as statements with respect to Management s beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Such forward-looking statements reflect Management s current beliefs and are based on information currently available to Management. These statements are not guarantees of future performance and are based on the Company s estimates and assumptions and are subject to risks and uncertainties, including those described in the Company s Management Discussion and Analysis regarding the 2014 audited financial statements, which could cause the Company s actual results to differ materially from the forward-looking statements to be discussed during this presentation. Although the forward-looking information discussed during this presentation is based upon what Management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. 2

3 Investment Highlights Revenue from approved products $14.2 million trailing twelve months revenue Robust pipeline of mid/late/development stage products $51.8 million in cash (at June 30, 2015) and no debt Strategy to unlock value 3

4 We Know How To Get Products Approved Pennsaid Pliaglis HLT Patch Oxoferin Indication Osteoarthritis of the knee Local analgesia prior to dermatological treatment and cosmetic surgery Local analgesia prior to painful needle injections Treatment of chronic wounds 4

5 We Know How To Partner Pennsaid Pliaglis HLT Patch Oxoferin 5

6 Pennsaid 2%

7 Pennsaid 2% - FDA Approved and Selling in the U.S. Topical and Transdermal Drug Delivery Market 27M U.S. patients with osteoarthritis Targeting U.S. NSAID market Indication Indication Benefits U.S. Commercial Status Treating the pain of osteoarthritis of the knee(s) Low systemic exposure to minimize side effects Only twice per day dosed topical NSAID in U.S. Metered dose dispenser U.S. rights sold to Horizon Pharma in October 2014 for US$45M Nuvo is Horizon s exclusive long-term manufacturer Follow-on product to Pennsaid, contains 2% diclofenac sodium 7

8 Pennsaid 2% U.S. Total Bottles Sold Weekly Since Launch Total Bottles 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Horizon launch January 1, 2015

9 Pennsaid 2% U.S. Average Total Bottles Sold Weekly Per Month Average Total Bottles/Week 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Horizon launch January 1, 2015

10 Pennsaid 2% - International Out-Licensing Opportunities Indication Acute pain for sprains and strains Available for out-licensing Licensed, not yet launched Launched 2014 Status Phase 3 study commenced July 2015 Results expected Q / Q PwC retained to support out-licensing initiative 10

11 WF10

12 WF10: A Potential Game Changing Therapy For Moderate to Severe Allergies WF10 Rebalances immune response Provides relief from all airborne allergies 5 day course of treatment lasts for 18 months to 2 years Competing against allergen specific immunotherapy (allergy shots) 12

13 WF10: Allergic Rhinitis Target Market Multi Billion $ U.S. Market Opportunity Eligible for Immunotherapy 10M Patients U.S. AR Prevalence M Patients 82 million people in the U.S. suffer from allergic rhinitis WF10 will target the 10 million patients who get limited relief from conventional products and are eligible for immunotherapy (allergy shots) WF10 U.S. peak annual sales forecast to be US$700M to $1.1B* 13 *2014 marketing report by Psscion Consulting commissioned by Nuvo interviewed patients, allergists and payers and forecast that WF10 would capture 10-15% of the U.S. refractory allergic rhinitis market and have peak U.S. annual sales of $700M to $1.1B.

14 WF10 vs. Immunotherapy Significant Advantages for Severe Allergic Rhinitis Sufferers WF10* Covers broad range of allergens Five days of treatment may provide 1-2 years of symptom relief Favourable safety profile Significant clinical benefit (Response rate 70%-90%) Immunotherapy Allergen specific Continuous dosing Possible side effects in product labels include severe anaphylactic shock Moderate clinical benefit *Source: Nuvo Phase 2 Clinical Trial Results, November

15 Positive Results from 2010 Single-Centre Allergic Rhinitis Phase 2 Trial Refractory patients sensitive to multiple allergens Total Nasal Symptom Score (TNSS) Patients received 1 daily infusion for 5 consecutive days, then no further treatment 6 12 Weeks Placebo: 30 Patients WF10: 30 Patients Statistically Significant P value <

16 2014 Multi-Centre Allergic Rhinitis Phase 2 Trial Seasonal and Perennial Patients Unexpected placebo response likely caused by insufficient exposure to pollens Total Nasal Symptom Score (TNSS) Patients received 1 daily infusion for 5 consecutive days, then no further treatment Weeks WF10 WF10 with chlorate removed WF10 with chlorite removed Placebo 16

17 2014 Multi-Centre Allergic Rhinitis Phase 2 Trial Perennial Allergy Patients Clear separation from placebo for perennial allergy patients Total Nasal Symptom Score (TNSS) Patients received 1 daily infusion for 5 consecutive days, then no further treatment Weeks WF10 WF10 with chlorate removed WF10 with chlorite removed Placebo 17

18 WF10 Next Step 2015 Phase 2 Environmental Exposure Chamber (EEC) / Field Study EEC/Field Field EEC Patients qualified for study Patients symptoms recorded during grass & ragweed seasons Patients grass & ragweed symptoms measured STUDY RESULTS Q2 Q2/Q3/Q4 Q4 Q4 2015/ Q Have randomized and dosed 74 patients with WF10 or saline placebo Single-centre, double blinded, placebo-controlled design Study will be run by Inflamax recruiting patients from Toronto area External costs estimated at $5.0 million 18

19 WF10 Future will Depend on 2015 Phase 2 Trial Results 2015 WF10 Phase 2 Trial WF10 Development WF Co. Co. - independent public company independent public company - owned by Nuvo shareholders Owned by Nuvo shareholders WF Co. WF10 development - independent terminated public company - Owned by Nuvo shareholders 19

20 Nuvo Strategy

21 2015 Six-Month Review Horizon launch of Pennsaid 2% going extremely well Commenced WF10 Phase 2 study in allergic rhinitis Commenced Pennsaid 2% Phase 3 study intended to support international approvals and out-licensing Retained PwC to assist in securing international license agreements for Pennsaid 2% 21

22 Unlocking Shareholder Value Nuvo currently has Revenue generating approved products Development stage assets like WF10 that require R&D investment R&D investment > cash generated by approved products If 2015 WF10 Phase 2 study successful, spin out WF10 into a separate public company Acquire late stage and/or incremental revenue generating businesses/products that can increase Nuvo revenue and profitability 22

23 Current Structure Nuvo Shareholders Nuvo Research Inc. Cash flow from approved products Development stage assets including WF10 23

24 Potential New Structure with Public WF10 Development Co.* Nuvo Shareholders Nuvo Shareholders Nuvo Nuvo Research Inc. Cash flow from approved products Cash flow from acquisitions WF10 Development Co. R&D products, including WF10 in development 24 *WF10 Development Co. could be a) Owned substantially by Nuvo b) Owned 100% by Nuvo shareholders by Nuvo dividending shares of WF Development Co. to them c) Some combination of a) and b)

25 Upcoming Milestones Commenced WF10 Phase 2 study in allergic rhinitis Q Commenced Phase 3 Pennsaid 2% acute pain study (international approvals & out-licensing) Q Pennsaid 2% Phase 3 study results Q4 2015/Q WF10 Phase 2 study results Q4 2015/Q Out-licensing of Pennsaid 2% for multiple international jurisdictions - ongoing Strategic product/business acquisitions - ongoing 25

26 Financial Summary Stock Symbol Market Cap (Sept 14/15) Cash (June 30/15) Debt TSX: NRI $57.1 million $51.8 million NIL 52 Week Low-High $ $10.36 Current Share Price (Sept 14/15) Shares Outstanding Revenue (TTM at June 30, 2015) $ million $14.2 million 26

27 Investment Highlights Revenue from approved products $14.2 million trailing twelve months revenue Robust pipeline of mid/late/development stage products $51.8 million in cash (at June 30, 2015) and no debt Strategy to unlock value 27

28 To discuss opportunities contact: Investor Relations (905) TSX: NRI 28