Ltr Pharma Limited · ASX:LTP
Ltr Pharma — Investor Presentation (July 2024)
30 slides from Ltr Pharma's investor presentation, Jul 24, 2024
Slide 1: Fast-acting nasal spray treatment for erectile dysfunction
For personal use only Fast-acting nasal spray treatment for erectile dysfunction Investor Overview | July 2024
Slide 2: Important notice & Disclaimer
Important notice & Disclaimer ‣ Nature of Document: This presentation has been prepared and issued by LTR Pharma Ltd (Company) to provide general information about the Company. The information in this document is For personal use only in summary form and should not be relied upon as a complete and a
Slide 3: Executive Summary
Executive Summary LTR Pharma is commercialising SPONTAN® A ‘First in Class’ rapid, on demand nasal spray treatment for Erectile Dysfunction (ED) Bringing to For personal use only market the first Successful pivotal pharmacokinetic study nasal spray for ED Demonstrated rapid onset, consistency of del
Slide 4: Investment Highlights
Investment Highlights LTR Pharma positioned in a clear gap in the market For personal use only Expedited Compelling pivotal Blockbuster Blue chip Multiple upcoming path to market pharmacokinetic market with issues partners milestones study data Repurposed drugs with novel Demonstrated rapid onset at
Slide 5: Industry overview
For personal use only Industry overview* *Frost & Sullivan, Market Report: (September 2023) The Erectile Dysfunction Medicines Market
Slide 6: Estimated Market size
Estimated Market size Forecast to be US$6.0B market by 2028 US$6.0B $5.94B For personal use only US$5.0B 7.0% CAGR US$4.0B $3.68B $4.15B $3.87B US$ billions $3.61B US$3.0B $3.38B $3.16B $2.95B $2.76B $2.58B US$2.0B US$1.0B $1.56B $1.67B $1.79B $1.18B $1.27B $1.36B $1.45B $1.11B US$0.0B 2021 2022 202
Slide 7: Current treatments
Current treatments Gold standard are PDE5 inhibitors which have several drawbacks For personal use only 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) avai
Slide 8: The search for a new branded option
The search for a new branded option Significant opportunity for branded assets Opportunity to capture For personal use only 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 fragme
Slide 9: Company Overview
For personal use only Overview Company
Slide 10: Nasal Administration
Nasal Administration Delivery mechanism can solve many of issues facing PDE5 inhibitors For personal use only 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 sy
Slide 11: SPONTAN Overview
SPONTAN® Overview A novel delivery of a proven ED drug For personal use only Drug repurposing Focused on changing the method of administration of Vardenafil, an existing and approved drug already in global markets since 2003 Intra-nasal delivery Intra-nasal Vardenafil formulation, SPONTAN®, is fast
Slide 12: Proven Competitive Advantages
Proven Competitive Advantages Distribution through partnering/licensing and direct-to-consumer models For personal use only Sildenafil Tadalafil Avanafil Vardenafil Mode of delivery Nasal Oral Oral Oral Oral A faster acting Low dosage lower dose drug formulation Rapid absorption with a better safety
Slide 13: SPONTAN Pivotal Pharmacokinetic Study
SPONTAN Pivotal Pharmacokinetic Study Rapid onset effect, consistent delivery and improved safety profile For personal use only ‣ SPONTAN nasal spray achieved rapid absorption and faster Parameter Vardenafil onset of action compared to oral PDE5 inhibitors.1 (5mg) (10mg) oral ‣ SPONTAN delivered sim
Slide 14: Pivotal Pharmacokinetic clinical study
Pivotal Pharmacokinetic clinical study Results to support early access in Australia and regulatory pre-submission meetings For personal use only Trial objective To assess the relative bioavailability of Vardenafil following administration of SPONTAN® as a nasal spray compared to Vardenafil tablets.
Slide 15: Expedited path to market
Expedited path to market Seeking FDA and TGA approvals in the US & Australia and then other key markets For personal use only Targeting a 505 (b)(2) approval Previous approval of oral tablet Targeting NDA FDA pathway regulatory strategy, on Vardenafil by the FDA would allow filing 1st half of CY bas
Slide 16: Commercialisation Pathways
Commercialisation Pathways Seeking FDA and TGA approvals in the US & Australia and then other key markets ‣ The successful clinical study results outlining the strong safety profile will enable near-term 1 commercialisation in Australia through the early access schemes, SAS and APS For personal use
Slide 17: Key Milestones
Key Milestones Multiple value inflection points for the Company throughout Financial Year 2025 For personal use only Near Term Execution Pathway FY25 Q1 Q2 Q3 Q4 Full Pivotal Clinical Trial Data Early Access Use Australia Pre-submission Meeting with FDA & TGA Additional Products to Pipeline Licensin
Slide 18: Offer Overview & Timetable
For personal use only Offer Overview & Timetable
Slide 19: Capital Raising Overview
Capital Raising Overview For personal use only A single tranche placement to sophisticated and institutional investors to raise a minimum of A$10.5 million (before costs) (Placement) via the Offer Structure issue of up to 14.34m new fully paid ordinary shares (New Shares) utilising the Company’s ava
Slide 20: Use of Funds & Timetable
Use of Funds & Timetable Use of Funds $10.5m (AUD) Sales & Marketing Partnering $2,000,000 For personal use only Telemedicine Consumer Website $1,000,000 R&D Pipeline Expansion $2,000,000 Regulatory Studies $1,400,000 Working Capital $3,470,000 IR / Cost of the Offer $630,000 Total $10,500,000 Event
Slide 21: Corporate Overview
Corporate Overview Strong Funding to Commercial Outcomes For personal use only (ASX:LTP) Public Market Overview (19 July 2024) Share Price A$0.9000 52-week range A$0.24 – A$1.05 Market Cap A$125.48M Cash equivalents (31 March 2024) A$5.28M Top 20 shareholder percentage 57.94% 1. As at market close F
Slide 22: Appendix
For personal use only Appendix
Slide 23: Company History
Company History Progressed company substantially derisking the proposition For personal use only 2020 - 2021 Acquired exclusive worldwide rights to Establishment of the Validated the US FDA’s 505(b)(2) develop, manufacture and market SPONTAN® Scientific Advisory Board regulatory pathway through an t
Slide 24: Medtech R&D Partnership & Licensing
Medtech R&D Partnership & Licensing Partnership and licensing deals continue to grow, remaining tilted towards milestone-based payments For personal use only Medtech: R&D Partnership & Licensing Totals and Percentage Up Front1 US$12.0B 35% $11.3 29% 30% US$10.0B 25% US$8.0B 19% $6.2 20% US$6.0B $5.4
Slide 25: ED and its Causes
ED and its Causes Psychological A major factor in causes relationship breakdown Physical Relationship problems causes Stress / anxiety For personal use only Cardiovascular issues Depression Hormonal issues Diabetes Erectile disfunction (ED) is a medical Injury condition wherein an individual is Side
Slide 26: Prevalence in key markets
Prevalence in key markets As risk factors become more prevalent, so does ED Global ~322m men by 2025 For personal use only 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 Presentation 26
Slide 27: Key Risks
For personal use only Key Risks
Slide 28: Key Risks
Key Risks Early clinical state of LTP's candidate product has proceeded to a pharmacokinetic clinical trial stage. No guarantee can be provided that the proposed clinical work will be successful or development result in a product approved for use by a regulatory agency; however, an investigator lead
Slide 29: Key Risks
Key Risks Intellectual Property There is no guarantee that LTP’s intellectual property, whether owned or licensed from others, comprises all of the rights that LTP may require to freely commercialise its product candidates. Patent applications in significant markets have been lodged in respect of LT
Slide 30: Contact
For personal use only Contact investors@ltrpharma.com www.ltrpharma.com