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LTR PHARMA LIMITED — AGM Information 2024
Nov 26, 2024
65273_rns_2024-11-26_c300235c-6eb4-48a8-80ba-b69172d8b2f3.pdf
AGM Information
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Annual General Meeting
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A transformative year of clinical and commercial success
Australian Financial Year
Q2 2023/24
ASX listing
Clinical data presented at WMSM Dubai
Q3 2023/24 Q4 2023/24 Q1 2024/25 Q2 2024/25 Manufacturing Positive clinical Global partnership Final clinical study validation study results with Aptar Pharma results confirmed completed 470% faster TGA Special Access Strategic joint Clinical study absorption Scheme venture for recruitment demonstrated commenced telehealth platform commenced TGA Authorised Study recruitment Prescriber Scheme and dosing launched completed Q3 2023/24
AGM 2024
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Investment Highlights
LTR Pharma positioned in a clear gap in the market
Expedited path to market
Compelling pivotal pharmacokinetic
Blockbuster Blue chip market with issues partners
Multiple upcoming milestones
AGM 2024
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Physical causes
Psychological Impact
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‣ Relationship problems
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‣ Heart Health
A significant healthcare challenge affecting relationships and quality of life
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‣ Hormone Balance
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‣ Metabolic Health
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‣ Medical Treatments
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‣ Hair loss
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‣ Mental Wellbeing
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‣ Day to day stress
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‣ Weight loss
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‣ Antidepressants
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Prevalence of ED with individuals with cardiovascular risk factors,
hypertension and diabetes, is reported as high as 50%
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AGM 2024
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Global Market Need
ED can impact physical and psychological health
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USA China
Aus
EU
60.7%
~30m ~33m ~150m
of males 45y/o+
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AGM 2024
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Estimated Market size
Forecast to be US$6.0B market by 2028
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US$6.0B
7.0% CAGR
US$5.0B
US$4.0B $4.15B
$3.87B
$3.61B
US$3.0B $3.16B $3.38B
$2.95B
$2.76B
$2.58B
US$2.0B
US$1.0B $1.11B $1.18B $1.27B $1.36B $1.45B $1.56B $1.67B $1.79B
US$0.0B
2021 2022 2023F 2024F 2025F 2026F 2027F 2028F
US ROW
US$ billions
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Online sales expansion Majority of ED medication is now sold through online channels
AGM 2024 6
Current treatments Gold standard are PDE5 inhibitor tablets which have several drawbacks
Phosphodiesterase-5 (PDE5) inhibitors are first-line treatments
Issues with PDE5 inhibitor tablets
Main Time before sexual Approval Generic Does not work Product Brand(s) activity for dose Date (US) availability for 30-35% of patients Sildenafil Viagra 1 hour+ 1998 Yes Long response time of 1 hour + Tadalafil Cialis 1 hour+ 2003 Yes affects spontaneity Levitra, Adverse reactions Vardenafil 1 hour+ 2003 Yes Staxyn in up to 35% of patients Avanafil Stendra 30 minutes+ 2012 No TGA early 12 mins No access
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AGM 2024 7
SPONTAN[®] The Fast-Acting Solution Transforming ED treatment with speed and confidence
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Speed Matters
Peak concentration in as little as 9 mins, 470% faster than oral tablets Average onset: 12 mins vs 56 mins
Healthcare Professional Insight
Patients can respond in as little as 5 minutes, . well before peak concentration is reached[*]
*Based on healthcare professional feedback
Less is More
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Half the dose Similar effectiveness Better delivery consistency
Safety
Validated safety profile No severe events Clinically proven
Time to peak concentration
(minutes)
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Tablets
0 20 40 60
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Making headlines – all eyes on LTP
LTR Pharma engaged positively with all tiers of the media in FY24, including quality, regular coverage in industry, business, health and top tier mediums.
Whilst a high volume of headlines focused on the Company’s outstanding share price growth, the story also attracted coverage in health-focused consumer mediums including Men’s Health, Body + Soul, state and national newspapers, and more. These stories were initiated in partnership with leading key opinion leader, Professor Eric Chung, and clinical practitioner and advocate, Melissa Hadley Barrett, and the Company’s management team.
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AGM 2024 9
Company History
Progressed company substantially derisking the proposition
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to Establishment of the[[®]] Scientific Advisory Board in the field of Men’s Health Received early acceptance Adopted Mayne Health from IP Australia for our as a commercial manufacturing product trademark name partner to produce SPONTAN[®] to “SPONTAN[®] ” GMP standards
Acquired exclusive worldwide rights to develop, manufacture and market SPONTAN[[®]] through a licence agreement with SDS
Validated the US FDA’s 505(b)(2) regulatory pathway through an expert regulatory review
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Optimised delivery and commercial development of its nasal formulation with drug stability data from nasal spray device developer
Developed the Initial Public Offer (IPO) protocol for its Completed an oversubscribed IPO. bioequivalence Listed on the ASX on 11 December study, and gained 2023 and raised AU $7M. ethics approval
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Study results released Australian Early Co-development Online Platform SPONTAN[®] 's clinical study Access Scheme with Aptar Pharma (Q1 CY25) to support regulatory filings, commencement Partnership for the Increasing access enable early Australian Provision of commercialisation of through telehealth market access and SPONTAN[®] for SPONTAN in the USA preparation for licensing and unmet needs and other key partnering discussions markets
2020 Proof of Completed Conducted crucial Concept trial packaging studies derisking activities results published in for final commercial before moving into 2023 in The Journal product ahead of clinical development of Sexual Medicine bioequivalence study and commercial sales
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Board of Directors
Seasoned leadership driving innovation and growth in healthcare
LEE RODNE
(Executive Chairman)
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25 years in healthcare and tech sectors in both public ASX and private enterprises.
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Led a healthcare spin out from ASX Fortescue Metals Group (Allied Medical, Admedus Ltd)
▲ Worked with Professor Ian Frazer on advancing therapeutic vaccines into clinical studies
▲ Track record of commercializing medical devices in Australia, North America, Europe and Asia with significant experience in Nasal Spray product sales.
MS MAJA MCGUIRE
(Independent Non-Executive Director)
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15 years of experience providing corporate and compliance advice to ASX-listed public companies as an Australian-qualified lawyer.
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This includes working with listed companies as a non-executive director, general counsel, company secretary and in private practice.
▲ Current Non-Executive Chair of ASX listed TechGen Metals (ASX:TG1), non-executive director of Kuniko (ASX: KNI) and non-executive director of Indiana Resources Limited (ASX(IDA).
DR JULIAN CHICK
(Independent Non-Executive Director)
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20 years experience in senior management and board positions, including in ASX-listed companies Avexa Ltd, Admedus Ltd and current Chair of Cann Group Ltd (ASX:CAN).
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Over 8 years of experience in investment banking and reviewing healthcare and biotechnology investment opportunities for private equity investors and venture capitalists.
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AGM 2024
Global Team, Strategic US Presence Experienced leadership across key markets
Executive Chairman | Lee Rodne
25 years in healthcare and tech sectors in both public ASX and private enterprises.
General Manager & Business Development US | Tom Riester
25 years experience in sales and management in digital health, medical device and precision medicine.
Chief Operating Officer | Peter McLennan
17 years experience in investment banking, investor relations and operations.
Vice President – US Sales & Marketing | Mike Sweeting
30 years in the Pharmaceutical industry in US commercial sales and Market Access.
Chief Finance Officer | Jacques Shipper
14 years experience in Finance, Commercial Management and Controller roles.
Medical Liaison Officer | Chris Rosewarne
Experienced pharmaceutical and medical device industry leader with over 20 years experience.
Vice President Operations & Clinical Development | Dr Monil Shah 20 years of Pharmaceutical and biotechnology industry experience in drug development.
Vice President, Global Regulatory Affairs | Kip Vought
25 years across global markets - Senior Pharmaceutical R&D and regulatory executive.
Vice President – Commercial | Danny Zanardo
25 years commercial experience in the Australian and global healthcare sectors across pharmaceuticals and medical devices.
Chief Medical Officer | Prof Geoffrey Strange
20 years experience in Pharmaceutical and medical industries as a Senior Executive and Medical Researcher.
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AGM 2024 12
Upcoming Milestones Multiple value inflection points in the year ahead
Expanding Manufacturing product portfolio scale up
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Online Regulatory
prescribing studies
& meetings
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Potential
partnerships &
licensing
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AGM 2024
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