Ltr Pharma Limited · ASX:LTP
Ltr Pharma — Investor Presentation (December 2023)
25 slides from Ltr Pharma's investor presentation, Dec 11, 2023
Slide 1: SPONTAN Investor Presentation
LTR Pharma LTR Pharma ASX:LTP For personal use only SPONTAN® Fast-acting nasal spray treatment for Erectile Dysfunction Investor Presentation | 11 December 2023 IPO Presentation 1
Slide 2: Important Notice & Disclaimer
IMPORTANT NOTICE & DISCLAIMER LTR Pharma 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 in summary form and For personal use only should not be relied upon as a compl
Slide 3: Introduction
LTR Pharma LTR Pharma For personal use only INTRODUCTION 3 IPO Presentation 3
Slide 4: Executive Summary
EXECUTIVE SUMMARY LTR Pharma Bringing to market the first nasal spray for ED LTR Pharma is commercialising SPONTAN® For personal use only A ‘First in Class’ rapid, on demand nasal spray treatment for Erectile Dysfunction (ED) Successful Phase I Human Proof of Concept Indicating 6x faster than oral a
Slide 5: Investment Highlights
INVESTMENT HIGHLIGHTS LTR Pharma LTR Pharma positioned in a clear gap in the market For personal use only Expedited path Promising proof Blockbuster market to market of concept with issues Repurposed drugs with novel Demonstrated 6x faster than Existing PDE5 inhibitors have a delivery methods can re
Slide 6: Industry Overview
LTR Pharma LTR Pharma For personal use only INDUSTRY OVERVIEW 6 IPO Presentation 6
Slide 7: ED and Its Causes
ED AND ITS CAUSES LTR Pharma A major factor in relationship breakdown Erectile disfunction (ED) is a medical condition wherein an individual is unable For personal use only to get or keep an erection for satisfactory sexual intercourse Physical causes Psychological causes Cardiovascular issues Relat
Slide 8: Prevalence in Key Markets
PREVALENCE IN KEY MARKETS LTR Pharma As risk factors become more prevalent, so does ED For personal use only EU: ~33m USA: CHINA: ~30m ~150m GLOBAL: ~322m men by 2025 AUS: 60.7% of males 45y/o+ Source: Frost and Sullivan Report, The Erectile Dysfunction Medicines Market, September 2023 IPO Presentat
Slide 9: Current Treatments
CURRENT TREATMENTS LTR Pharma Gold standard are PDE5 inhibitors which have several drawbacks Phosphodiesterase-5 (PDE5) inhibitors For personal use only Issues with PDE5 inhibitors are first-line treatments Time before Main Approval Generic Does not work Product sexual activity Brand(s) for dose Dat
Slide 10: Estimated Market Size
ESTIMATED MARKET SIZE LTR Pharma Forecast to be US$6.0B market by 2028 $5.94B use only US$6.0B 7.0% CAGR US$5.0B US$4.0B $3.68B $4.15B For personal $3.87B US$ billions $3.61B $3.38B US$3.0B $3.16B $2.95B $2.76B $2.58B US$2.0B US$1.0B $1.56B $1.67B $1.79B $1.27B $1.36B $1.45B $1.11B $1.18B US$0.0B 20
Slide 11: Nasal Administration
NASAL ADMINISTRATION LTR Pharma Delivery mechanism can solve many of issues facing PDE5 inhibitors For personal use only Advantages vs oral administration More rapid onset of action Higher rate of absorption Lower adverse reactions Less active pharmaceutical ingredients required Less drug degradatio
Slide 12: Company Overview
LTR Pharma LTR Pharma For personal use only COMPANY OVERVIEW 12 IPO Presentation 12
Slide 13: Company History
COMPANY HISTORY LTR Pharma Progressed company substantially derisking the proposition 2020-21 2023 For personal use only Acquired exclusive Establishment of the Validated the US FDA’s Developed the protocol for 2020 Proof of Concept worldwide rights to develop, Scientific Advisory Board in 505(b)(2)
Slide 14: SPONTAN Overview
SPONTAN® OVERVIEW LTR Pharma 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, SDS-08
Slide 15: Competitive Advantages
COMPETITIVE ADVANTAGES LTR Pharma A faster acting lower dose drug formulation with a better safety profile SPONTAN Sildenafil Tadalafil Avanafil Vardenafil For personal use only Mode of delivery Nasal Oral Oral Oral Oral Low dosage Rapid absorption Quick onset of action Higher bioavailability Fewer
Slide 16: Proof of Concept Trial Data
PROOF OF CONCEPT TRIAL DATA LTR Pharma Confirmation of rapid onset effect For personal use only 12 patients in a randomised, single dose cross- The trial was published in May 2023 with over study of males aged between 24 -45 The Journal of Sexual Medicine confirmed: The delivery of the SDS-089 nasal
Slide 17: Proposed Bioequivalence Trial
PROPOSED BIOEQUIVALENCE TRIAL LTR Pharma Results expedite NDA filing & ARTG registration in the US & Australia • Trial objective: To assess the relative bioavailability of For personal use only Vardenafil following administration of SPONTAN® as a nasal spray compared to Levitra® tablets • Trial desig
Slide 18: Expedited Path to Market
EXPEDITED PATH TO MARKET LTR Pharma LTR requires FDA and TGA approval to operate in the US & Australia For personal use only Targeting a 505 (b)(2) Previous approval of oral tablet FDA approval pathway Vardenafil by the FDA would Targeting NDA filing regulatory strategy, on basis it allow inclusion
Slide 19: Commercialisation Timeline
COMMERCIALISATION TIMELINE LTR Pharma Multiple value inflection points H1 CY24 H2 CY24 H1 CY25 H2 CY25 For personal use only SPONTAN Product Manufacturing Manufacturing for clinical study and regulatory data SPONTAN Clinical Development Program Bioequivalence clinical study 2nd Nasal Spray Product 2
Slide 20: Long Term Development Pipeline
LONG TERM DEVELOPMENT PIPELINE LTR Pharma Repurposing existing oral drugs to intranasal delivery For personal use only Additional ED Pulmonary Arterial Scleroderma or Osteoporosis products Hypertension (PAH) systemic sclerosis Increasing range of ED A disorder characterised Immune disorder Where bon
Slide 21: Board & Management
LTR Pharma LTR Pharma For personal use only BOARD & MANAGEMENT 21 IPO Presentation 21
Slide 22: Board of Directors
BOARD OF DIRECTORS LTR Pharma Significant industry and listed company experience Lee Rodne Dr Julian Chick Maja McGuire For personal use only Executive Chairman Independent Non-executive Director Independent Non-executive Director • Lee holds over 25 years’ experience in • Julian is an experienced h
Slide 23: Key Management Team
KEY MANAGEMENT TEAM LTR Pharma High quality go-to-market team For personal use only Danny Zannardo Jacques Schipper Mike Sweeting VP, Commercial Chief Financial Officer VP, US Sales & Marketing Danny has over 25 years of commercial experience Jacques brings over 14 years of experience in Mike has ov
Slide 24: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD LTR Pharma Providing expert guidance, expertise and credibility For personal use only Professor Eric Chung Professor Russ Chess-Williams Eric is a consultant urological surgeon at Russ is the Director of the Centre for the AndroUrology Centre for Sexual, Urology Research an
Slide 25: www.ltrpharma.com
LTR Pharma LTR Pharma For personal use only WWW.LTRPHARMA.COM 25 IPO Presentation 25