A Revolution in drug delivery

Transcription

1 A Revolution in drug delivery Stephen Carter Chief Executive Officer Michael Stewart Chairman October 2017

2 Disclaimer The purpose of the presentation is to provide an update of the business of SUDA LTD (ASX:SUD) [ SUDA ]. These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by SUDA and should not be relied upon as an independent source of information. Please contact SUDA and/or refer to the Company's website for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside SUDA s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and SUDA s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by SUDA. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction. 2

3 WHAT WE DO Develop new technology for rapid and efficient absorption of drugs directly into the bloodstream through the oral mucosa (mouth lining) we make money through transactions by out-licensing our products with upfront & milestone payments & are developing a sustainable income through royalty payments 3

4 PATENTS UNDERPIN OUR STORY > 300 Drugs-Patent portfolio ( ) ArTiMist-Composition and Use Patents (2027) Sildenafil patents (2032) New Hydrotrope Platform Technology Patent (2037) Multiple Trademarks OroMist, Zolpimist, DuroMist, ArTiMist Proprietary trade secrets

5 World class products + patents to drive growth

6 FOUR YEARS OF EXPLOSIVE GROWTH PATENTS PRODUCTS TRANSACTIONS 0 >30 1 > VALUATION $20m?

7 DRIVEN BY LEADING EXPERTS Including Chief Technical Officer Dr Carol Worth B.Sc (JtHons), MSc. PhD C.Chem FRSC, C.Chem MRACI Development Chemist who has laid foundations for new IP to be build into Hydrotropes project Head of Projects Dr Deborah Cooper BSc (Hons), ARCS, MSc, PhD (Cantab) Biotech professional with 25 years experience expert in Cell Biology/Immunology, Clinical, Manufacturing, Product Development and Project Management

8 PATENT PORTFOLIO ATTRACTS PFIZER OroMist IP covers ~300compounds Our Hydrotrope technology enhances absorptionand permeation Specialise in composition formulation, stability system & taste-masking system Pfizer contracted SUDA to access our IP

9 DELIVERY SYSTEM IMPROVES DRUG EFFECTIVENESS Absorption of molecules via oral mucosa Onset of action Drug bioavailability Dosage concentration Concentration Receptor Cell ug/ml Potential side effects 0 60 min (Time) SUD-003 1st Gen SUD-003 New Gen Approx. 10x increase in absorption with new-generation SUD-003 vs. 1st generation at 60-minute time-point in ex-vivo buccal (cheek) membrane model 9

10 Innovative patents + products improve drug delivery

11 PRODUCTS Product Candidate, Selection Criteria Distinct benefits for the patients Unique Selling Point Improved onset of actionand bio-availability Reduced side effects Low risk regulatory pathway Competitive commercial advantage Potential global sales footprint Monopoly through patent protection 11

12 MIDAZOLAM (SUD005) Clinical win + large market Midazolam is used to treat epileptic seizures in largeglobal market Delivery of Midazolam via a SUDA s oral spray would offers clinical advantagesandcommercial opportunities Patients present with strong muscular convulsion Tablets or injections, both present difficulties in administration Buccolam (current treatment) - marketed by Shire Pharmaceuticals. Launched 2012, generating strong sales (US$300m) & growth + 80% pa. Administration of Buccolam still presents difficulties for nursing staff & doctors 12

13 GROWING PRODUCT PIPELINE Product API Pre-clinical Clinical Approval Mkt Size Partnerships *ZolpiMist Zolpidem Insomnia USA $2.1bn Eddingpharm (China) TEVA (Brazil, Mexico, Chile) ArtiMist Artemether Malaria >$500m SUD-002 Ondansetron Chemotherapy induced nausea & vomiting $2.5bn Kwang Dong (Korea) SUD-001 Sumatriptan Migraine headache $3.2bn DuroMist Sildenafil Erectile dysfunction $4.1bn SUD-004 Sildenafil PAH $2.7bn SUD-005 Midazolam Epileptic seizures >$300m SUD-0XX Anagrelide Cancer >$1bn * SUDA has an exclusive license to ZolpiMist in all countries excluding USA and Canada 13

14 Transactions with major pharmas validate our IP

15 CHINA OPENS ITS DOORS ZolpiMist Eddingpharm agreement in China Exclusive license to develop and commercialise ZolpiMist in China Eddingpharm is large Chinese pharma company covering more than 3,000 hospitals in 29 provinces Total value of deal could exceed $34m - Upfront payment ~$0.4m - Registration milestone ~$0.3m - Product supplied by SUDA - Escalating tiered royalties 15

16 Eddingpharm CEO: An estimated 45% of Chinese, 590m people, have problems with sleep. ZolpiMist is an excellent fit with our current infrastructure and strategy.

17 LATIN AMERICA FOLLOWS ZolpiMist Teva agreement in Latin America Exclusive license to develop and commercialise ZolpiMist in Brazil, Mexico and Chile, plus option-to-license in Argentina, Israel andaustralia Teva is top-20 Pharma and world s largest generics company Total value of deal could exceed $55m - Upfront payment of~$0.4m - Milestones of ~$2.3m - Product supplied by SUDA - Double-digit royalties 17

18 Teva, the world s largest generics company, has the commercial scale to maximise sales of ZolpiMist. Potentially very lucrative for SUDA based on royalties and supply

19 TRANSACTIONS Feasibility andoptionagreement withpfizerconsumer Healthcare Fee-for-service agreement to formulate two well known over-thecounter drugs into oral sprays Pfizer has option to negotiate global commercial licence (upfront, milestones and royalties) 19

20 OTHER TRANSACTIONS Service business Co-development Added-value development services to companies seeking to formulate APIs into proprietary oro-mucosal sprays with unique advantages Formulation services for Rx, OTC, veterinary, vitamin and nutraceutical oral sprays Pharmaceutical development laboratory carrying out world class research Australian Registered Research Agency since 2016 In 2017, accreditation upgraded to highest international standard of ISO 9001:2015 Targeting Australian TGA GMP licence in 2017 SUDA is a Registered Research Provider 20

21 Undervalued with earnings growth

22 PROJECTED REVENUE GROWTH 30,000,000 25,000,000 20,000,000 $24m 15,000,000 10,000,000 $15.6m 5,000,000 $9.3m total receipts

23 SUD Valuation/Share Price (A$) $0.300 $0.250 $0.200 $0.150 Mid-case represents >900% upside from current share price Lower Case, 9cps $0.100 NDF Valuation Summary Mid Case, 17cps Upper Case, 25cps $350.0 $300.0 $250.0 $200.0 $150.0 $100.0 Valuation/Market Capitalisation (A$m) $0.050 SUD Share Price, 1.7cps $50.0 $0.000 Lower Case Mid Case Upper Case SUD Share Price $0.0

24 Key data & financial snapshot Corporate key data ASX Code SUD:AU Current share price (Australian $) $ week range $0.015-$0.028 Average volume (30-day) 1.3 million Market cap $22 million Financials Receipts (Fcst) $9,300,000 $15,600,000 $24,000,000 Net operating Cash-outflows ($10,600,000) ($13,400,000) ($15,100,000) Net Cash at 30 June $560,000 $2,700,000 $14,100,000 Shares on issue Convertible Notes 1,220 million $2.0 million convertible to 84 million shares 24

25 Board & Senior Management Chairman Michael Stewart MD/ CEO Stephen Carter BSc CFO/Director & Co.Sec Joseph Ohayon CA, MBA Chief Business Officer Nick Woolf MA (Oxon) FCCA Strong foundation in capital markets and experience in international aid 30 years experience in drug development including cancer drugs. Delta West/Pfizer, Solbec Worked in healthrelated industries for over 15 years and held several CFO roles and directorships 15 years industry experience in international business development. Previously at Phylogica and Oxford BioMedica

26 NEXT STEPS ü ü ü ü ü ü ü ZolpiMist master license deal in Europe Further partnering deals with SUDA s other candidates Monetisation of ArTiMist Expansion of Pfizer collaboration Early sales success for TEVA with ZolpiMist Expansion of TEVA markets Approval of ZolpiMIst in Australia and Europe

27 SUDA IS GOING PLACES Growing world class patents and products Transactions with major pharmas validate Suda Leading technical team to drive innovation Strong earnings growth over next five years China could provide x factor in earnings growth