ASX Release No. 929 17 July 2018 Page 1 of 2 ACN 090 987 250 ASX Release SUDA PHARMACEUTICALS LTD: CORPORATE PRESENTATION PERTH, AUSTRALIA – 17 July 2018: SUDA PHARMACEUTICALS LTD (ASX: SUD) announces that the Company’s Corporate Presentation, with the title “A revolution in drug delivery”, in relation to the Rights Issue is attached. The following presentation will be provided to brokers and investors in relation to the potential shortfall of the Rights Issue. Further information: STEPHEN CARTER CHIEF EXECUTIVE OFFICER / MANAGING DIRECTOR SUDA Ltd Tel: +61 8 6142 5555 sjcarter@sudapharma.com
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ASX Release No. 929 17 July 2018 Page 1 of 2
ACN 090 987 250
ASX Release
SUDA PHARMACEUTICALS LTD: CORPORATE PRESENTATION
PERTH, AUSTRALIA – 17 July 2018: SUDA PHARMACEUTICALS LTD (ASX: SUD) announces that the Company’s Corporate Presentation, with the title “A revolution in drug delivery”, in relation to the Rights Issue is attached.
The following presentation will be provided to brokers and investors in relation to the potential shortfall of the Rights Issue.
Further information: STEPHEN CARTER CHIEF EXECUTIVE OFFICER / MANAGING DIRECTOR SUDA Ltd Tel: +61 8 6142 5555 [email protected]
About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals 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. ZolpiMist is partnered with Eddingpharm in China and Teva Pharmaceuticals in Latin America. SUDA has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration for ArTiMist®, its 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, PAH, epileptic seizures and pre-procedural anxiety. For more information, visit www.sudapharma.com
Stephen Carter – Managing Director/ Chief Executive Officer
July 2018
A Revolution in drug delivery…
DisclaimerThe purpose of the presentation is to provide an update of the business of SUDA PHARMACEUTICALS 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.
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KEY HIGHLIGHTS▪LEADER in the oro-mucosal spray technology
- Rapid absorption of drugs directly through oral mucosa directly into the bloodstream.- Unique advantages and benefits – faster reaction, less adverse side effects.
▪Worldwide Patents - strong protection of IP.
▪5 contracts in place with Pharma – milestone payments.
▪14 products at advanced stages of development.
▪12 Term sheets in various stages of negotiation for out-licensing and co-development projects. Footprints in Asia, USA and Europe. Focus now on deal closure
▪Revenue generation through transactions, licensing of products, upfront & milestone payments and royalty payments to create a growing and sustainable income stream.
▪Full and Final Settlement with Berlin Pharma removes all litigation risk and uncertainty 3
Unique advantages of Suda’s spray delivery
▪ The drug is ABSORBED DIRECTLY INTO THE BLOODSTREAM THROUGH THE MUCOSA
▪ This presents significant and unique benefits and advantages:
▪ LESS DRUG IS REQUIRED - direct absorption avoids hepatic first-pass effect which means less drug needsto be metabolized.
▪ FASTER ONSET OF ACTION – time at which drug becomes effective is significantly reduced.
▪ REDUCTION IN DOSE due to increased bioavailability as drug is absorbed directly into the bloodstream.
▪ LESS ADVERSE SIDE EFFECTS – reduction in dose means reduction in adverse side effects
▪ REDUCES plasma level variability for drugs with food effect
▪ AVOIDS GASTRO-INTESTINAL SIDE EFFECTS
▪ GREATER TOLERABILITY in patients with nausea and vomiting
▪ Can be administered to unconscious and uncooperative patients
▪ HIGH PATIENT COMPLIANCE due to elimination of injection pain or the need to swallow1,2
or inhale
1. >40% of adults experience difficulties swallowing2. >50% of children (6 to 11 years) have problems swallowing tablets
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SUDA’s model
• Patented Technology
• Targeting first in class market leading products
• Reduced Clinical and Development program and risk profile
• Well known drugs with known safety profile and clinical history
Experienced Pharmaceutical executive with over 30 years’ management of pharmaceutical companies, drug development, manufacturing, marketing and commercialisation in early-stage to mature companies. Previous senior roles (GM/MD / Chairman) in Delta West, Upjohn, Pharmacia, Pfizer, Solbec, Delmedica, and Colltech.
Non-Executive DirectorDavid Phillips
Senior Business Development Executive with over 30 years in the healthcare industry. Including 16 years in GSK, 12 years in Biotech and as Managing Partner of SR One (GlaxoSmithKline’s Corporate Venture Fund). David has been responsible for over 50 Pharma/Biotech deals and 10M&A transactions.
CFO/Director & Co. SecJoseph Ohayon CA, MBA
Experienced Financial and Business Executive who has worked in health-related industries for over 15 years and held several CFO roles and directorships.
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Corporate Slide
• Current market capitalisation (@ 0.5c) $6m
• Estimated Cash $3.7m*
• NDF Research target valuation (Feb18 ) $112m to $329m**• NDF Research Calculated target Price 4.6c to 13.7c*
• Top 20 Hold 35%
• 12 month Range 0.5c to 2.7c
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* Assumes full take up of Rights issue**Source: NDF Research report February 2018. Target valuation range $112-$329M. NDF is an independent equity research firm based inSydney, Australia which focuses on Life Science companies that are publicly traded on the ASX Ltd.
76X more drug in the blood stream than tablet results in ability to significantly reduce the dose.
Very rapid absorption results in faster onset of action
3X more drug in the blood stream than tablet results in ability to significantly reduce the dose.
Oro-mucosal spray delivery | Unique advantagesBioequivalence with enhanced properties
Earlier therapeutic drug levels = faster
onset
FIVE YEARS OF EXPLOSIVE GROWTH
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PRODUCTS “1”
TRANSACTIONS “0”
PATENTS “0” TRANSACTIONS “5”
PRODUCTS “300”
PATENTS “30”
2013
2018
Transactions with major pharma's validate our IP…
▪ Exclusive license to develop and commercialise ZolpiMist in China
▪ Eddingpharm is large Chinese pharma company covering more than 3,000hospitals in 29 provinces
▪ Total value of deal could exceed $34m
▪ Upfront payment of approx. $0.4m
- Registration milestone of approx. $0.3m
- Product supplied by SUDA
- Escalating tiered royalties
ZolpiMist™| Eddingpharm agreement in China
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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.”
▪ Exclusive license to develop and commercialise ZolpiMist in Brazil, Mexicoand Chile, plus option-to-license in Argentina, Israel and Australia
▪ Teva is top-20 Pharma and world’s largest generics company
▪ MAA submitted in first LatAm country in December 2017
▪ Total value of deal could exceed $55m
- Upfront payment of approx. $0.4m
- Milestones of approx. $2.3m
- Product supplied by SUDA
- Double-digit royalties
ZolpiMist™| Teva agreement in LatAm
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Teva has the commercial scale to maximize sales of ZolpiMist in the territory
This deal is potentially very lucrative for SUDA based on royalties and supply
$6 million
$462 Million
2 productsFentanyl Spray
CBD Spray
$3.9Billion1 Product
Sativex CBD Spray
Significant difference in valuations between Australia and the US Markets
BD STRATEGY
• Building global brand recognition and BD leads.
• David Phillips recently appointed as non exec director, David hasextensive global BD experience
• Refined BD Strategy
• 31 projects under CDA’s and 12 term sheets under negotiation.
• Suda to invest BD into High Value US market
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• Worlds largest pharmaceutical market US accounts for over 45% of global pharmaceutical sales
• US generic market is currently $84bn with CAGR of 6.5% growing to$112bn in 2022
• Oncology Market (WW) CAGR at 12.7% to $192bn by 2022
• US market has higher valuation for assets
• US has higher prices and reimbursement rates than ROW
• High M&A activity in US
• Deals done by F2F and B2B meetings
• Suda to employ US based BD Specialist in Q1 FY2019
US Market Snapshot
Business opportunities• Anagrelide:
• Significant opportunity to develop a unique patented product for the adjuvant or neo-adjuvant treatment of cancer.
• Very large market opportunity
• Good Patent protection
• Breadth of literature being published about role of platelets in cancer progression.
• Strong SAB being put in place
• Significant barriers to entry for other players
Program Q3-18 Q4-18 Q1-19 Q2-19 Q3-19
Solubility
Formulation
Relative mucosal transmission
Proof of Concept
Business Development
Business opportunities• Midazolam:
• For the treatment of epileptic seizures
• Significant market opportunity• Good deal momentum underway
• Strong interest from potential partners
• First in class product
• Strong SAB being put in place
• Significant barriers to entry for other players
Program Q3-18 Q4-18 Q1-19 Q2-19
IP Finalisation
Relative mucosal transmission
Proof of Concept
Clinical Development
Business Development
• Cannabis projects• Strong market interest in Cannabinoids (CBD)
• Large market opportunity
• Oromist a good platform for CBD products.
• Joint Venture or Joint Development project
• Strong interest from 4 potential JD partners due to the potential of a faster onset of action to treat pain and epilepsy
Business opportunities• Joint Development/ Joint Venture Projects
• Fully funded projects
• Joint ownership on new products with license agreements on our technology
• Allows scale up of operations with project funding
• Currently >15 JD/JV opportunities
• Pfizer project still open
• Suda has a strong network of Industry seasoned consultants
• Some of Suda’s partners are Specialised Pharmaceutical companies without significant international Development, Clinical or Regulatory expertise.
• Suda can leverage our network to provide services as part of its development program for partners.
• Suda can leverage the network to find new opportunities.
Leverage connections to expand business opportunities
Anticipated Milestones
Anticipated News Product Expected Date
*Co Development Deal CBD Q1 FY2019
*Licensing deal for ASEAN region ZolpiMist Q1 FY2019
*Licensing and Development Deal USA SUD-001H Q2 FY2019
*Licensing deal for part of Europe ZolpiMist Q2 FY2019
*TGA approval of Marketing Authorisation Application SUD-006 Q2 FY2019
*Licensing Deal SUD-002 Q3 FY2019
*Licensing deal for part of Europe SUD-001H Q3 FY2019
*Global partnership or trade sale SUD-006 Q3 FY2019
*Licensing deal SUD-003 Q4 FY2019
SUDA IS GOING PLACES
• Growing world class patents and products
• Transactions with major pharma's validate Suda
• Strong Experienced senior management and Board (over 100 Years combined experience)
• Leading technical team to drive innovation
• Suda investing in Business Development Infrastructure to drive growth
