Slide 1: Fast-acting nasal spray treatment for erectile dysfunction
Fast-acting nasal spray treatment for erectile dysfunction Investor Update | March 2025
Slide 2: Important Notice & Disclaimer
Important Notice & Disclaimer ‣ Nature of Document: This presentation has been prepared and issued by LTR Pharma Ltd ‣ Forward looking statements: This presentation contains forward-looking information about the (Company or LTP) to provide general information about the Company. The information in th
Slide 3: Executive Summary
Executive Summary LTR Pharma is commercialising SPONTAN® and ROXUS® Bringing to ‘First-in-Class’ rapid, on-demand nasal spray treatment market the first for Erectile Dysfunction (ED) nasal spray for ED Successful pivotal pharmacokinetic study Demonstrated rapid onset and consistency of delivery Disr
Slide 4: Investment Highlights
Investment Highlights LTR Pharma positioned in a clear gap in the market Multiple Compelling pivotal Blockbuster Blue chip Multiple upcoming path to market pharmacokinetic market with issues partners milestones study data ‣ Expanding product ‣ SPONTAN® is available 5x faster absorption Existing PDE5
Slide 5: Market Problem & Opportunity
Market Problem & Opportunity
Slide 6: Understanding the Market Need
Understanding Physical causes Psychological Impact the Market Need ‣ Heart health ‣ Relationship problems A significant healthcare ‣ Hormone balance ‣ Mental wellbeing challenge affecting ‣ Diabetes ‣ Day to day stress relationships and ‣ Medical treatments quality of life ‣ Hair loss ‣ Weight loss
Slide 7: Prevalence In Key Markets
Prevalence In Key Markets As risk factors become more prevalent, so does ED Global ~322m men by 2025 USA China Aus EU 60.7% ~30m ~33m ~150m of males 45y/o+ Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023 Investor Update | March 2025 7
Slide 8: Estimated Market Size
Estimated Market Size Forecast to be US$6.0B market by 2028 US$6000.00.B $5.94B 7.0% CAGR US$5000.00.B US$4000.00.B $3.68B $4,151.00 $3,867.38 US$ billions $3,614.38 US$3000.00.B $3,377.92 $3,156.94 $2,950.41 $2,757.39 $2,577.00 US$2000.00.B US$1000.00.B $1,557.00 $1,667.00 $1,786.00 $1,183.00 $1,26
Slide 9: Current Treatments
Current Treatments Gold standard are PDE5 inhibitors which have several drawbacks Phosphodiesterase-5 (PDE5) Issues with inhibitors are first-line treatments PDE5 inhibitors Product Main Time before sexual Approval Generic Does not work Brand(s) activity for dose Date (US) availability for 30-35% of
Slide 10: The Search for a New Branded Option
The Search for a New Branded Option Significant opportunity for branded assets Opportunity to capture market share at higher margins Generics have grown to 700M* units annually ‣ Rapid erosion of branded volume following patent expiries ‣ No product differentiation in a fragmented market ‣ Low margi
Slide 11: Solution
RY LTR Pharma Solution SPONTAN
Slide 12: Nasal Administration
Nasal Administration Delivery mechanism can solve many of issues facing PDE5 inhibitors Advantages vs oral administration Less active More rapid pharmaceutical onset of action ingredients required Higher rate of absorption Less drug degradation due to bypassing the digestive system Lower adverse rea
Slide 13: SPONTAN Pivotal Pharmacokinetic Study
SPONTAN® Pivotal Pharmacokinetic Study Rapid onset effect, consistent delivery and improved safety profile ‣ SPONTAN® nasal spray achieved rapid absorption and Parameter Vardenafil faster onset of action compared to oral PDE5 inhibitors. (5mg) (10mg) oral ‣ SPONTAN® delivered similar bioavailability
Slide 14: SPONTAN The Fast-Acting Solution
SPONTAN® The Fast-Acting Solution Transforming ED treatment with speed and confidence Speed Matters Healthcare Professional Insight ‣ Peak concentration in as little as Patients can respond in as little as 5 minutes, 9 mins, 470% faster than oral tablets Average onset: 12 mins vs 56 mins well before
Slide 15: Company Overview
RY LTR Pharma Company Overview
Slide 16: Company History
Company History Progressed company substantially derisking the proposition 2020 - 2021> Acquired exclusive worldwide rights Establishment of the Validated the US FDA’s 505(b)(2) to develop, manufacture and market Scientific Advisory Board in regulatory pathway through an SPONTAN® through a licence a
Slide 17: Global Co-Development Agreement
Global Co-Development Agreement Nasdaq listed Aptar Pharma Strategic partnership driving regulatory success and market readiness Partnership Foundations Regulatory & Development Activities ‣ Focuses on commercialisation in the US Extractables & Leachables (E&L) studies and other key markets ‣ Valida
Slide 18: SPONTAN - FDA Regulatory Milestone
SPONTAN - FDA Regulatory Milestone Clear Path Forward Pre-IND Meeting Completed Strategic Advantage Regulatory Program ‣ FDA endorsement of overall development approach ‣ Regulatory clarity enhances development Check Points ‣ Alignment on streamlined clinical development plan efficiency ‣ Clear unde
Slide 19: Introducing ROXUS
Introducing ROXUS® Personalised ED Care Personalised Care Compounding Product Features Pharmacy Market* ‣ Vardenafil-based nasal spray ‣ Identical active ingredient to SPONTAN® 5.2% ‣ Targeting the personalised medicine CAGR sector $10B Development Status ‣ Positioned for fast-acting, on-demand ‣ St
Slide 20: Accelerating US Market Entry Dual-Track Strategy
Accelerating US Market Entry Dual-Track Strategy Path 1: SPONTAN® > Full Approval ‣ FDA 505(b)(2) pathway ‣ Real-world patient and prescriber insights ‣ Full market authorisation upon approval ‣ Target: Mass market Path 2: ROXUS > Personalised Medicine ‣ Revenue generation from the US market 2026 ‣
Slide 21: Clear path to Market
RY LTR Pharma Clear path to Market
Slide 22: In-Market NOW
In-Market NOW Growing Telehealth and Online Prescribing via TGA’s Early Access Programs 1 ‣ RHC – experts in treating ED and early adopters of SPONTAN JV with Restorative ‣ Online bookings, consults, men’s health education, telehealth solutions and prescribing SPONTAN Health Clinic (RHC) on ‣ https:
Slide 23: Expedited path to market
Expedited path to market Seeking FDA and TGA approvals in the US & Australia and then other key markets FDA TGA United States Australia Targeting a 505 (b)(2) approval pathway regulatory strategy, Targeting Category 1 - Type F Application process is expected on basis it is “repurposing” of an existi
Slide 24: Commercialisation Pathways
Commercialisation Pathways Seeking FDA and TGA approvals in the US & Australia and other key markets 1. Australia’s TGA SAS & APS early access ‣ The successful clinical study results outlining the strong efficacy and safety profile enables access in Australia through the TGA’s early access schemes,
Slide 25: Capturing the Digital Health Revolution
Capturing the Digital Health Revolution Building tomorrow's ED treatment platform today Explosive Growth Strategic Commercial Key of telehealth Position Pathway Differentiators US$140B+ ‣ Positioning SPONTAN® for online access Online Prescribing Q1 CY25 ‣ Platform development – Q4 CY24 ‣ Specialist
Slide 26: Multiple Value Inflection Points
Multiple Value Inflection Points Key milestones and catalysts anticipated in 2025/26 Early Access Expansion in Australia Expanding Product Portfolio Range ‣ Growing Online prescribers ‣ SPONTAN® derivatives (Multiple product versions for sale) ‣ General Practitioner awareness engagement ‣ New indica
Slide 27: Contact
Contact investors@ltrpharma.com www.ltrpharma.com Authorised for release by the Board of Directors