Ltr Pharma Limited · ASX:LTP
Ltr Pharma — Investor Presentation (March 2024)
22 slides from Ltr Pharma's investor presentation, Mar 18, 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 | March 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: Introduction
For personal use only Introduction
Slide 4: 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 Phase I Human Proof of Concept nasal spray for ED Indicating 6x faster than oral administrati
Slide 5: Investment Highlights
Investment Highlights LTR Pharma positioned in a clear gap in the market For personal use only Expedited Promising Blockbuster Blue chip Multiple upcoming path to market proof of concept market with issues partners value inflection points Repurposed drugs with Demonstrated 6x faster Existing PDE5 Co
Slide 6: Industry overview
For personal use only Industry overview
Slide 7: 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 Injury Erectile disfunction (ED) is a medical condition wherein an individual is unable to get
Slide 8: 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 8
Slide 9: 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 10: Estimated Market size
Estimated Market size Forecast to be US$6.0B market by 2028 For personal use only $5.94B US$6.0B 7.0% CAGR US$5.0B 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 11: 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 12: 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 13: Company Overview
For personal use only Overview Company
Slide 14: 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 15: 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 16: Competitive Advantages
Competitive Advantages 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 profile Quick onset of action Higher bioavailability Fewer side effects Invest
Slide 17: Proof of concept Trial data
Proof of concept Trial data Confirmation of rapid onset effect For personal use only 12 patients in a randomised, single dose The delivery of the SPONTAN nasal spray solution used a 100 ul cross-over study of males aged between 24-45 per dose nasal spray device manufactured by Aptar Pharma The trial
Slide 18: Pivotal Bioequivalence clinical study
Pivotal Bioequivalence clinical study Results expedite NDA filing & ARTG registration in the US & Australia For personal use only Trial objective – study has commenced To assess the relative bioavailability of Vardenafil following administration of SPONTAN ® as a nasal spray compared to Vardenafil t
Slide 19: Expedited path to market
Expedited path to market LTR requires FDA and TGA approval to operate in the US & Australia 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 at beginning (US) basis it is
Slide 20: Upcoming Key Milestones
Upcoming Key Milestones Multiple value inflection points in Calendar Year 2024 For personal use only Pivotal Early access Pre submission 2nd Nasal Spray Licensing / clinical trial use Australia meetings with product Partnering ‣ Recruitment FDA & TGA discussions ‣ Dosing ‣ Results Investor Presentat
Slide 21: Financial Summary
Financial Summary Strong Funding to Commercial Outcomes For personal use only (ASX:LTP) Public Market Overview (15 March 2024) Share Price A$0.32 52-week range A$0.25 – A$0.41 Market Cap A$46.00M Cash equivalents (31 December 2023) A$6.01M Top 20 shareholder percentage 57.94% Investor Presentation 2
Slide 22: Contact
For personal use only Contact investors@ltrpharma.com www.ltrpharma.com