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Immuron Ltd — Investor Presentation 2022
Aug 30, 2022
35121_rns_2022-08-30_29ced129-268a-4bb5-b002-1c970fd5d6bd.pdf
Investor Presentation
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INVESTOR PRESENTATION FY22 RESULTS & BUSINESS UPDATE
31 AUGUST, 2022 Steven Lydeamore - CEO
NASDAQ: IMRN ASX: IMC
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EXECUTIVE SUMMARY
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Immuron Ltd (ASX:IMC) (NASDAQ:IMRN) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases
| • | Two commercially available oral immunotherapeutic products – Travelan® and Protectyn® | |
|---|---|---|
| Company | • | Incorporated in Australia in 1994 and has been listed on the ASX since 1999 and NASDAQ since 2017 |
| Overview | • | Market capitalisation of $20.5 million as of 23 August 2022 with cash & cash equivalates balance of $22.1 million as of 30 July |
| 2022 | ||
| • | Refreshed corporate structure including two key hires - Steven Lydeamore as CEO and Joanne Casey as R&D Manager | |
| • | Flagship product Travelan® once again in demand as global travel rebounded post lockdowns | |
| Business | • | Addressable market continues to grow as Immuron expands its distribution capability in FY23 |
| Update | • | Capable of producing highly specific orally active immunoglobulins to any enteric pathogen |
| • | Completing an assessment of the entire product portfolio, target markets, competitive advantage and, growth drivers | |
| • | FY22 revenue exceeded budget by 92% - driven by an early resurgence in global travel | |
| FY22 | • | Extremely strong balance sheet that will be supporting its refreshed organic growth strategy and new M&A strategy |
| Results & | ||
| Outlook | • | Set to file FDA IND and initiate a clinical trial for Travelan® (IMM-124E) this financial year |
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CEO UPDATE & CORPORATE SNAPSHOT
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Refreshed the executive team, bringing on Steven Lydeamore as CEO and Joanne Casey as R&D Manager
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Steven brings over 30 years’ of experience in the pharmaceutical industry including over 10 years working for Canada’s largest pharma company, Apotex
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Joanne has a BSc Hons in Biomedical Technology and a PhD in Medicine, with experience in antibody development and translation into preclinical and clinical studies
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Strong presence in the Australian retail pharmacy network, where evidence-based OTC products are sold
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In the US, continued relationship with Passport Health, the largest provider of travel medicine services with travel clinics in the United States
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Plan to launch Protectyn®, a liver and gut health product into our network
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Immuron continues to have a large retail shareholder base in both the US and Australia with BNY Mellon Asset Management (American Depository Shares) having a 35% stake
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The board and management are aligned with our shareholders, currently holding 3%
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| Financial Snapshot | Financial Snapshot |
|---|---|
| Shares on Issue | 227,798,346 |
| Total Options | 21,303,877 |
| Last Traded Price | $0.090 |
| 52 week High/Low | 0.170/0.076 |
| Market Cap | $20.5m |
| Cash & Cash Equivalents (as at June 30) | $22.1m |
- *As at 23-Aug-2022
| Substantial Shareholders | Substantial Shareholders | Substantial Shareholders |
|---|---|---|
| Holder | Units | % of CSO |
| BNY Mellon Asset Management | 79,677,424 | 35.0 % |
| Management & Board | 6,904,554 | 3.0 % |
| Authentics Australia Pty. Ltd. | 6,000,000 | 2.6 % |
| Grandlodge | 3,846,712 | 1.7 % |
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*As at 23-Aug-2022
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Plan to increase market communication with quarterly updates
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ADDRESSABLE MARKET & INDUSTRY OVERVIEW
Immuron’s products are a subset of the global digestive health ~$15b+ market, which a multi-billion-dollar market*
Travelers diarrhea treatment market is large and growing at a ~7% CAGR CAGR of ~7% over 2019-2022*
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Travelan® has large market potential given that acute diarrhea affects millions of travelers each year
Based on US annual travel numbers and a penetration rate of $83m 15%, the market potential is estimated at $83m**
Based on EU travel numbers and a penetration rate of 15%, the $50m market potential is estimated at $50m**
Clostridioides difficile infections (CDIs) to grow to almost $1.7 $1.7b billion by 2026, according to GlobalData
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IQVIA Consumer Health Category QuickView MAT Q1 2019
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** IMC Company Report - Travelan Market Analysis 2019
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*** Centers for Disease Control and Prevention Yellow Book
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Billion Dollar Market
Travelers diarrhea treatment market is large and growing at a CAGR of ~7%
Industry tailwinds
Travel picking up significantly following COVID lockdowns
Frequent Symptom
30% - 70% of travelers experience traveler’s diarrhea***
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TECHNOLOGY PLATFORM
Immuron’s proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal (“GI”) tract and can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces.
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STEP 1
STEP 2
STEP 3
FINAL PRODUCT
Development of Highly Specific Vaccines
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Isolation of Hyperimmune antibody-rich bovine colostrum
Oral Antimicrobial therapeutics without drawbacks of antibiotics
Toxin Neutralization + Clearance of targeted gut pathogens
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Reduce occurrence and reduce/relieve diarrhoea
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Reduce/relieve abdominal cramping Reduce/relieve gastrointestinal pain Assists repair of gastrointestinal/gut wall lining Enhance/promote immune defence Enhance/promote health liver function
Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)
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STATUS OF PRODUCT PORTFOLIO AND KEY MILESTONES
Immuron’s Clinical Programs
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The business is completing an assessment of the entire product portfolio, target markets, competitive advantage and, key growth drivers
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US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military
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IMM-124E (Travelan®) IND is anticipated to be filed with the FDA in 2H2022
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Market evaluation is being undertaken before initiating further trials of IMM-529 for Clostridioides difficile
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Uniformed Services University is anticipated to commence in 1H2023 a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region
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Naval Medical Research Center is on clinical hold for the proposed trial of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC)
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Compound or Indication Phase Phase Phase Market
brand name I II III
Traveler’s
IMM-124E
Diarrhea ETEC
Travelan®
challenge
Clostridioides
difficile
IMM-529
Infection &
Recurrance
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Our Partners’ Clinical Programs
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Compound or Partner Phase Phase Phase Market
brand name I II III
Travelan® & Uniformed Services
Florastor® University
CampETEC Naval Medical
Research Center
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*Further information on the clinical programs can be found on slide 11
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DISTRIBUTION CAPABILITY
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Australia USA Canada
Retail Pharmacy
B2B
E-commerce
Established Developing
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Key Commentary
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The Australian retail network includes over 3,500 pharmacies
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In the USA, the key B2B customer is Passport Health - the largest network of travel clinics
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We are exploring options to expand B2B business in airlines, cruise ships, health & wellness segments
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Immuron’s own shopfront on amazon.com will be introduced in the US and Canada during FY23
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Entry into Retail Pharmacy in USA will be explored in FY23
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PROFIT & LOSS
| 1 | $000s |
|---|---|
| Profit & Loss FY22 FY21 Var %* |
|
| Australian Sales 201 $ 40 $ 404% Rest of World Sales 564 $ 106 $ 433% |
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| Total Revenue 765 $ 146 $ 425% |
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| 2 3 4 |
Cost of Goods (242) $ (51) $ 373% |
| Gross Profit 524 $ 95 $ 453% |
|
| Gross Profit Margin 68% 65% 5% General Expenses (3,429) $ (3,979) $ -14% Share based payment expenses (95) $ (2,116) $ -96% Research and development expenses (658) $ (1,367) $ -52% Sellingand marketingexpenses (417) $ (288) $ 45% |
|
| Total Expenses (4,599) $ (7,749) $ -41% |
|
| 5 | Other Income 958 $ 617 $ 55% Other Gains/(losses) 248 $ (1,342) $ -118% |
| FY22 – H2 accounts are unaudited Operating profit/(loss) (2,870) $ (8,380) $ -66%* |
|
Key Commentary
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1• Strong rebound in global sales – up 425% on pcp – driven by the rebound in international travel
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Note: total revenue in FY20 was over $2.5m
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2 High margin business with Gross Profit margins at 68%
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3• Realigned cost base for growth with expenses down 14% on pcp, driven by the reduction in employee benefits and general expenses
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4 Decisions on investments in commercial products and R&D will be made following completing an assessment of the entire product portfolio, target markets, competitive advantage, and key growth drivers
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5• Operating loss significantly improving, 66% on pcp from ($8.4m) to ($2.9m)
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FY22 Other Income contains - general R&D grants (71%), Australia R&D tax concession (27%) & other (2%)
*FY22 – H2 accounts are unaudited
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BALANCE SHEET
| 1 | $000s |
|---|---|
| Balance Sheet 30-Jun-22 30-Jun-21 |
|
| Cash & Cash Equivalents 22,110 $ 25,047 $ Receivables 663 $ 335 $ Inventories 327 $ 293 $ Other Current Assets 572 $ 78 $ |
|
| Total Current Assets 23,672 $ 25,753 $ Property, plant and equipment 227 $ 34 $ Inventories 957 $ 1,267 $ |
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| Total Non-Current Assets 1,184 $ 1,300 $ |
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| Total Assets 24,856 $ 27,053 $ |
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| 3 2 |
Trade and other payables 1,161 $ 758 $ Other current liabilities 342 $ 363 $ |
| Total Current Liabilities 1,503 $ 1,122 $ Employee benefit obligations 0 $ 36 $ Other non-current liabilities 175 $ - $ |
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| Total Non-Current Liabilities 175 $ 36 $ |
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| Total Liabilities 1,678 $ 1,158 $ |
|
| Net Assets 23,177 $ 25,895 $ |
Key Commentary
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1 Immuron is well funded with over $22.1m in cash & cash equivalents
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2 Trade and other payables rise with the increased business activity
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3 No debt - the $175k amount is the recognition of a lease commitments >12 months
*FY22 – H2 accounts are unaudited
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BUSINESS POSITIONED FOR ORGANIC GROWTH AND NEW M&A STRATEGY
Organic Growth Strategy
M&A Strategy
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Focus on commercialised products and nearterm development extensions, including:
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1 Travelan®:
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By pursuing growth through M&A of a fragmented market, IMC believes that it will be able to increase market geographies, sales channels and penetration driving revenue growth and ultimately shareholder value
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Sales expansion across target geographies
- Our M&A Key Criteria focusses on:
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Growth in distribution network and sales & marketing initiatives
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Product development (new formulations including once daily dosing) e.g. FDA approval
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2 Protectyn®:
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Sales expansion across target geographies
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Growth in distribution network and sales & marketing initiatives
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Product development and broader applications
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Expand market verticals & product offering
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1
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2 • Expand existing customer base
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3 • Cost & Earnings Synergies 4 • Strength of IP and Management
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Distribution network and sales & marketing by each
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5 product
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KEY MILESTONES ANTICIPATED TO DRIVE VALUE
| KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE | KEY MILESTONES ANTICIPATED TO DRIVE VALUE |
|---|---|---|---|---|---|---|---|
| 2H 2022 |
1H 2023 |
2H 2023 |
1H 2024 |
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| Travelan® • File IND1 for single dose IMM-124E per day ETEC2 challenge clinical trial • Initiate ETEC IMM-124E CHIM3 clinical trial • Topline results for IMM- 124E ETEC CHIM clinical trial CampETEC • Submit Complete Response Letter (CRL) to FDA Clinical Hold for CampETEC clinical challenge study’ • Initiate NMRC4 ETEC CampETEC CHIM clinical trial • Initiate NMRC Campylobacter CampETEC CHIM clinical trial • Topline results for NMRC CampETEC ETEC CHIM clinical trial • Topline results for NMRC CampETEC Campylobacter CHIM clinical trial IMM-529 • IMM-529 cGMP manufacture5 • IMM-529 IND Pre-IND submission5 • IMM-529 IND submission5 • Initiate IMM-529 phase 2 CDI clinical trial5 Travelan® & Florastor® • Initiate USU6 P3TD IMM- 124E field clinical trial |
Travelan® & Florastor®
- Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Naval Medical Research Center; 5. Pending market evaluation being complete in CY22; 6. Uniformed Health Services University of the Health Sciences
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THANK YOU
12
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SCIENTIFIC REFERENCES
Travelan® (IMM-124E)
Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI:
to 90% of volunteers 10.3109/00365521.2011.574726
Travelan as a broad Spectrum anti-bacterial Immuron Limited, 29 April, 2011
Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating US Department of Defense, Armed Forces Research Institute of
broad potential for prevention of traveler’s diarrhea Medical Sciences (AFRIM), 4 September, 2019
Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals US Department of Defense, Armed Forces Research Institute of
compared to placebo and demonstrated a significant clinical benefit Medical Sciences (AFRIM), 5 September, 2018
Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, US Department of Defense, Armed Forces Research Institute of
and Shigella Medical Sciences (AFRIM), 30 January, 2017
Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), Islam et al., 2020. Submitted to mSphere, American Society for
and bioactivity of HBC against common enteric pathogens Microbiology
Bioactive Immune Components of Travelan® Clin Vaccine Immunol 24:e00186-16.
https://doi.org/10.1128/CVI.00186-16
Hyperimmune bovine colostrum reduces gastrointestinal carriage of uropathogenic Escherichia coli Human Vaccines & Immunotherapeutics, 15:2, 508-513, DOI:
10.1080/21645515.2018.1528836
Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages
Murine Colitis 785–797, https://doi.org/10.1093/ecco-jcc/jjy213
IMM-529
Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5
alternative
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