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ASX Release No. 872 15 August 2017 Page 1 of 1
ACN 090 987 250
ASX Release
SUDA LTD: INVESTOR PRESENTATION
PERTH, AUSTRALIA – 15 August 2017: SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that Mr. Stephen Carter, Managing Director and CEO, and Mr. Michael Stewart, Chairman, are meeting with investors, brokers and media in Melbourne and Sydney from 15-18 August 2017.
The presentation follows.
Further information: STEPHEN CARTER CHIEF EXECUTIVE OFFICER / MANAGING DIRECTOR SUDA LTD Tel: +61 8 6142 5555 sjcarter@sudaltd.com.au
NOTES TO EDITORS: About SUDA LTD SUDA LTD (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA’s product pipeline includes ZolpiMist™, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. SUDA’s most advanced development-stage product, ArTiMist®, is a novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of migraine headache, chemotherapy-induced nausea and vomiting, erectile dysfunction and pre-procedural anxiety. For more information, visit www.sudaltd.com.au
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Stephen Carter – Chief Executive OfficerMichael Stewart – Chairman
August 2017
A Revolution in drug delivery…
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DisclaimerThe 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 containmay require further explanation and/or clarification. Accordingly, these slides and the informationthey contain should be read in conjunction with past and future announcements made by SUDA andshould not be relied upon as an independent source of information. Please contact SUDA and/or referto the Company's website for further information.
The views expressed in this presentation contain information derived from publicly available sourcesthat 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 ofassumptions which may prove incorrect and the current intentions, plans, expectations and beliefsabout future events are subject to risks, uncertainties and other factors, many of which are outsideSUDA’s control. Important factors that could cause actual results to differ materially from assumptionsor expectations expressed or implied in this presentation include known and unknown risks. Becauseactual 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 statementscontained in this presentation with caution.
This presentation should not be relied on as a recommendation or forecast by SUDA. Nothing in thispresentation should be construed as either an offer to sell or a solicitation of an offer to buy or sellshares in any jurisdiction.
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WHAT WE DO
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▪ Develop new technology forrapid and efficient absorption ofdrugs directly into the bloodstreamthrough the oral mucosa (mouthlining)…
…we make money throughtransactions by out-licensing ourproducts with upfront & milestonepayments & are developing asustainable income through royaltypayments
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PATENTS UNDERPIN OUR STORY
▪ > 300 Drugs-Patent portfolio (2017-2026)
▪ ArTiMist-Composition and Use Patents (2027)
▪ Sildenafil patents (2032)
▪ New Hydrotrope Platform Technology Patent (2037)
▪ Multiple Trademarks▪ OroMist, Zolpimist, DuroMist, ArTiMist
▪ Proprietary trade secretsFor
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World class products + patents to drive growth…
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FOUR YEARS OF EXPLOSIVE GROWTH
0 >30
1 >300
0 5
2013 2017
?$20mVALUATION
PATENTS
PRODUCTS
TRANSACTIONS
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DRIVEN BY LEADING EXPERTS
Including…
Chief Technical OfficerDr Carol WorthB.Sc (Jt Hons), MSc. PhD C.ChemFRSC, C.Chem MRACI
Development Chemist who has laid foundations for new IP to be build into Hydrotropesproject
Head of ProjectsDr Deborah CooperBSc (Hons), ARCS, MSc, PhD (Cantab)
Biotech professional with 25 years experience – expert in Cell Biology/Immunology, Clinical, Manufacturing, Product Development and Project Management
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PATENT PORTFOLIO ATTRACTS PFIZER
▪OroMist® IP covers ~300 compounds
▪Our Hydrotrope technology enhancesabsorption and permeation
▪ Specialise in composition formulation,stability system & taste-masking system
▪Pfizer contracted SUDA to access our IP
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DELIVERY SYSTEM IMPROVES DRUG EFFECTIVENESS
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Absorption of molecules via oral mucosa
Onset of action
Drug bioavailability
Dosage concentration
Potential side effects0
200
400
600
800
1000
1200
1400
1600
1800
2000
60 min (Time)
Concentration Receptor Cell ug/mL
SUD-003 1st Gen SUD-003 New GenApprox. 10x increase in absorption with new-generation SUD-003 vs. 1st generation at 60-minute time-point in ex-vivo buccal (cheek) membrane model
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Innovative patents + products improve drug delivery…
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PRODUCTSProduct Candidate, Selection Criteria
▪ Distinct benefits for the patients
▪ Unique Selling Point
▪ Improved onset of action and bio-availability
▪ Reduced side effects
▪ Low risk regulatory pathway
▪ Competitive commercial advantage
▪ Potential global sales footprint
▪ Monopoly through patent protectionFor
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MIDAZOLAM (SUD005)…Clinical win + large market
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▪ Midazolam is used to treat epileptic seizures in large global market
▪ Delivery of Midazolam via a SUDA’s oral spray would offers clinicaladvantages and commercial 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
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GROWING PRODUCT PIPELINE
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USA
Product API Mkt SizeApprovalClinicalPre-clinical
$2.1bnInsomnia*ZolpiMist™ Zolpidem
Chemotherapy induced nausea & vomitingSUD-002 $2.5bnOndansetron
Epileptic seizuresSUD-005 >$300mMidazolam
Migraine headacheSUD-001 $3.2bnSumatriptan
Erectile dysfunctionDuroMist™ $4.1bnSildenafil
PAHSUD-004 $2.7bnSildenafil
>$500mMalariaArtiMist® Artemether
Partnerships
Kwang Dong (Korea)
Eddingpharm (China)TEVA (Brazil, Mexico, Chile)
CancerSUD-0XX >$1bnAnagrelide
* SUDA has an exclusive license to ZolpiMist™ in all countries excluding USA and Canada
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Transactions with major pharmasvalidate our IP…
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CHINA OPENS ITS DOORSZolpiMist™| Eddingpharm agreement in China
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▪ Exclusive license to develop and commercialise ZolpiMist inChina
▪ Eddingpharm is large Chinese pharma company coveringmore 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
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Eddingpharm CEO:
“An estimated 45% of Chinese, 590m people, have problems with sleep. ZolpiMist is an
excellent fit with our current infrastructure and strategy.”
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LATIN AMERICA FOLLOWSZolpiMist™| Teva agreement in Latin America
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▪ Exclusive license to develop and commercialise ZolpiMist inBrazil, Mexico and Chile, plus option-to-license in Argentina,Israel and Australia
▪ 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
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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
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TRANSACTIONS
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▪ Feasibility and option agreement with Pfizer Consumer Healthcare
⎻ Fee-for-service agreement to formulate two well known over-the-counter drugs into oral sprays
⎻ Pfizer has option to negotiate global commercial licence (upfront,milestones and royalties)
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OTHER TRANSACTIONSService business | Co-development
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▪ 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
Added-value development services to companies seeking to formulate APIs into proprietary oro-mucosal sprays with unique advantages
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Undervalued with earnings growth…
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0
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
30,000,000
2017-18 2018-19 2019-20
PROJECTED REVENUE GROWTH
total receipts
$9.3m
$15.6m
$24m
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Lower Case, 9cps
Mid Case, 17cps
Upper Case, 25cps
SUD Share Price, 1.7cps
$0.0
$50.0
$100.0
$150.0
$200.0
$250.0
$300.0
$350.0
$0.000
$0.050
$0.100
$0.150
$0.200
$0.250
$0.300
Lower Case Mid Case Upper Case SUD Share Price
Val
uat
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/Mar
ket
Cap
ital
isat
ion
(A
$m
)
SUD
Val
uat
ion
/Sh
are
Pri
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A$
)
NDF Valuation Summary
Mid-caserepresents >900% upside from current share price
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Key data & financial snapshot
Corporate key data
ASX Code SUD:AU
Current share price (Australian $) $0.017
52 week range $0.015-$0.028
Average volume (30-day) 1.3 million
Market cap $22 million
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Financials 2017-18 2018-19 2019-20
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 1,220 million
Convertible Notes $2.0 million convertible to 84 million shares
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Board & Senior Management
Chairman Michael Stewart
Strong foundation in capital markets and experience in international aid
MD/ CEOStephen CarterBSc
30 years’ experience in drug development including cancer drugs.Delta West/Pfizer, Solbec
Chief Business Officer Nick WoolfMA (Oxon) FCCA
15 years industry experience in international business development. Previously at Phylogica and Oxford BioMedica
CFO/Director & Co.SecJoseph OhayonCA, MBA
Worked in health-related industries for over 15 years and held several CFO roles and directorships
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NEXT STEPS
✓ 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
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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
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