Ltr Pharma Limited · ASX:LTP
Ltr Pharma — Investor Presentation (December 2024)
33 slides from Ltr Pharma's investor presentation, Dec 10, 2024
Slide 1: Fast-acting nasal spray treatment for erectile dysfunction
For personal use only Fast-acting nasal spray treatment for erectile dysfunction Capital Raising Presentation |10 December 2024 Strictly Private and Confidential - For Sophisticated and Professional Investors Only in Australia, New Zealand, Singapore, Hong Kong, the United Kingdom and the United Sta
Slide 2: Important notice & Disclaimer
Important notice & Disclaimer ‣ Nature of Document: This presentation has been prepared and issued by LTR Pharma Ltd (Company or LTP) to provide general information about the Company. The information in this document is in summary form and should not be relied upon as a complete and accurate represe
Slide 3: Executive Summary
LTR Pharma is commercialising SPONTAN® Executive A ‘First in Class’ rapid, on-demand nasal spray treatment for Erectile Dysfunction (ED) Summary Successful pivotal pharmacokinetic study Bringing to Demonstrated rapid onset and consistency of delivery For personal use only market the first nasal spra
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 470% faster absorption than
Slide 5: Market Problem & Opportunity
For personal use only Market Problem & Opportunity
Slide 6: Understanding the Market Need
Understanding Psychological Impact the Market Need Physical causes ‣ Relationship problems ‣ Heart Health A significant healthcare ‣ Mental Wellbeing ‣ Hormone Balance challenge affecting For personal use only ‣ Day to day stress relationships and ‣ Diabetes quality of life ‣ Medical Treatments ‣ Ha
Slide 7: 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 Corporate Presentation 7
Slide 8: 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 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: 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 11: Solution
For personal use only Solution
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: 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 Parameter Vardenafil faster onset of action compared to oral PDE5 inhibitors. (5mg) (10mg) oral ‣ SPONTAN® delivered s
Slide 14: SPONTAN The Fast-Acting Solution
SPONTAN® The Fast-Acting Solution Transforming ED treatment with speed and confidence For personal use only Speed Matters Healthcare Professional Insight Peak concentration in as little as 9 mins, 470% faster than oral tablets Patients can respond in as little as 5 minutes, Average onset: 12 mins vs
Slide 15: Company Overview
For personal use only Overview Company
Slide 16: 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 17: Aptar Pharma Global Co-Development Agreement
Global Co-Development Agreement - Nasdaq listed Aptar Pharma Strategic partnership driving regulatory success and market readiness For personal use only Partnership Foundations Regulatory & Development Activities ‣ Focuses on commercialisation in the US Extractables & Leachables (E&L) studies and ot
Slide 18: Clear path to market
For personal use only to market Clear path
Slide 19: Expedited path to market
Expedited path to market Seeking FDA and TGA approvals in the US & Australia and then other key markets Milestones for FDA For personal use only Preparation of regulatory documentation Targeting a 505 (b)(2) approval Previous approval of oral tablet Vardenafil by FDA pathway regulatory strategy, on
Slide 20: TGA Early Access Pathways
TGA Early Access Pathways Building real-world evidence to support regulatory submissions Special Access Scheme (SAS) Strategic Benefits For personal use only ‣ (Individual patient access) ‣ Early patient access before full approvals Current Authorised Prescriber Scheme (APS) ‣ Real-world data collec
Slide 21: Commercialisation Pathways
Commercialisation Pathways Seeking FDA and TGA approvals in the US & Australia and other key markets 1 For personal use only ‣ The successful clinical study results outlining the strong efficacy and safety profile enables Australia’s TGA SAS access in Australia through the TGA’s early access schemes
Slide 22: Capturing the Digital Health Revolution
Capturing the Digital Health Revolution Building tomorrow's ED treatment platform today Explosive Growth of telehealth Strategic Position For personal use only Positioning SPONTAN for online access US$140B+ market size by 2032* 1st test market in Australia early 2025 – replicate success globally Dig
Slide 23: Multiple Value Inflection Points
Multiple Value Inflection Points Key milestones and catalysts anticipated in H1 2025 (CY) Early Access Expansion in Australia Expanding Product Portfolio Range For personal use only • Online prescribers, additional men's health experts • SPONTAN derivatives • General Practitioner awareness engagemen
Slide 24: Offer Overview and Timetable
For personal use only Offer Overview and Timetable
Slide 25: Capital Raising Overview
Capital Raising Overview LTR Pharma has raised approximately $25.0 million via a Placement which will fully fund the Company through until the end of 2026, including commercial launch in the US For personal use only ● A single tranche Placement to sophisticated and institutional investors to raise a
Slide 26: Offer Timetable and Use of Funds
Offer Timetable and Use of Funds Indicative capital raising timetable1 Date (AEDT) Use of Funds A$m For personal use only Friday, 6th December US commercial preparations $10.5m Trading Halt, Bookbuild Opens 2024 Regulatory activities and animal $2.0m toxicity studies Trading Halt Lifted and Announce
Slide 27: Key Risks
For personal use only Key Risks
Slide 28: Key Risks
Key Risks Early clinical state of development LTP's candidate product has completed a pharmacokinetic clinical trial. No guarantee can be provided that the clinical work will be successful or result in a product approved for use by a regulatory agency and further clinical development may be necessar
Slide 29: Key Risks Cont.
Key Risks Cont. Product Liability As with all new biotechnology products, even after the granting of regulatory approval, there is no assurance that unforeseen adverse events or manufacturing defects will not arise. Adverse events could disrupt the supply chain and expose LTP to product liability cl
Slide 30: Key Risks Cont.
Key Risks Cont. Dependence on service providers The Company intends to operate a significant amount of its key clinical activities through a series of contractual relationships with independent contractors and suppliers. The Company relies on and will continue to rely on a number of its contractors
Slide 31: International Offer Restrictions
For personal use only International Offer Restrictions
Slide 32: International Offer Restrictions
International Offer Restrictions This presentation does not constitute an offer of new ordinary shares (“New Shares”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in
Slide 33: Contact
For personal use only Contact investors@ltrpharma.com www.ltrpharma.com Authorised for release by the Board of Directors