Firebrick Pharma Limited · ASX:FRE
Firebrick Pharma — Euroz Hartleys Healthcare Forum 2023
20 slides from Firebrick Pharma's conference presentation, Feb 1, 2023
Slide 1: Euroz Hartleys Healthcare Forum
For personal use only ASX: FRE EUROZ HARTLEYS HEALTHCARE FORUM 2 FEBRUARY 2023 1 FIREBRICK PHARMA LIMITED
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation is provided for information purposes only. The information in this presentation is in a summary form, does not purport to be complete and is not intended to be relied upon as advice For personal use only to investors or other persons. The information
Slide 3: Firebrick Pharma and Nasodine Nasal Spray
For personal use only Firebrick Pharma is an Australian pharmaceutical innovator that has developed a breakthrough treatment for the common cold: Nasodine® Nasal Spray Nasodine is a first-in-class nasal spray medicine that actually targets the viral cause of the common cold1,2 1 NASODINE is an inter
Slide 4: Upper respiratory infections and the common cold
Upper respiratory infections are spread The viruses enter the through virus-laden microdroplets in the air For personal use only nose and readily infect nasal cells triggering and on surfaces the symptom complex we call the “common cold” Hundreds of variants from runny six major virus families are n
Slide 5: Nasodine contains povidone-iodine (PVP-I)
Nasodine contains povidone-iodine (PVP-I) Same active ingredient as in Betadine® Sore Throat Gargle1 For personal use only PVP-I in Nasodine attacks essential viral proteins and membranes, inactivating most URI (cold) viruses within 60 seconds (in vitro)2 The effect is virucidal (permanent), broad-
Slide 6: Upper Respiratory Infection is the most common ailment
Upper Respiratory Infection (URI) Excludes all lower respiratory infections and otitis media (ear infections), i.e., equivalent to what we call the “common cold” Is by far the most common ailment afflicting humanity For personal use only Incidence of diseases worldwide in 2019* (billions of cases) ●
Slide 7: The Nasodine benefit: clinical evidence
The Nasodine benefit Clinical evidence in support of efficacy For personal use only 2019 Phase 3 clinical trial compared Nasodine ● TGA approval process with saline nasal spray (which is marketed for » Based on these results, Firebrick submitted an application relief of cold symptoms) to TGA for mar
Slide 8: Second Phase 3 trial (2022/23) is underway
Second Phase 3 trial (2022/23) is underway: Started in 2022, already 50% recruited, expected to be completed by mid-2023 For personal use only The trial is intended to provide Comparison of the two Phase 3 trials More subjects reduces risk additional clinical evidence to 2019 Phase 3 trial 2022/23 P
Slide 9: The importance of the 2022/23 Phase 3 trial
The importance of the 2022/23 Phase 3 Trial For personal use only SUCCESSFUL GLOBAL TGA APPROVAL EXISTING PIVOTAL LICENSING APPROVAL IN EUROPE LICENSEES TRIAL DEAL Definitive clinical Increases Allows filing of Allows filing for Provides the data proof that certainty of EU MAA marketing needed to cl
Slide 10: Nasodine Marketing
For personal use only Nasodine Marketing Once approved as an OTC for the common cold, what are Nasodine’s prospects? Draft packaging only, not approved by TGA 10
Slide 11: Australian OTC cold & flu market has rebounded in 2022
Australian OTC cold & flu market has rebounded in 2022 ● Cough & cold is one of the largest OTC For personal use only Cough & Cold Australia MAT Pharmacy Sales (Retail $ Value)* categories in Australia 200 » $534 million MAT Nov 2022 Cold & Flu Comb. » Sales grew dramatically (57%) in 2022 175 176 C
Slide 12: Common Cold Market Report conclusions
For personal use only Conclusions: “The current in-market products are used primarily to treat the symptoms of colds as opposed to the underlying cause, which is Common Cold viral infection. Consequently, a product that can effectively eliminate the viral causative agent and thereby reduce the level
Slide 13: Australian consumers say they are excited about Nasodine
Australian consumers say they are excited about Nasodine Survey of 308 Australian adults who typically suffered from colds* For personal use only What consumers rated as “very important” ● 89% of consumers surveyed were positive about Nasodine; most popular comment was: 54% Viruses do not develop re
Slide 14: Healthcare professionals are very supportive of Nasodine
Healthcare professionals are also very For personal use only Reasons HCPs are positive about Nasodine supportive of Nasodine Survey of 200 Australian GPs and 200 retail pharmacists* Rank Doctors Pharmacists ● 78% of GPs surveyed were positive about Nasodine It could help people by Targets/kills the
Slide 15: Nasodine's global opportunity
Nasodine’s global opportunity For personal use only OTC Market Size 2020-2030* ● The global OTC (over-the-counter) pharmaceutical 294 market is currently valued at more than US$170 billion 274 and expected to grow 72% by 2030* 256 ● Cough, cold & flu remedies segment is expected to 239 dominate the
Slide 16: Licensing strategy for 2023
Licensing strategy for 2023 For personal use only ● US and EU account for an estimated 60% of Nasodine’s global sales potential ● FRE has retained US-based Pullan Consulting1 to act as its licensing consultant and intermediary in this project » Pullan Consulting is a globally recognised expert in li
Slide 17: Firebrick growth opportunities after launch of Nasodine
Firebrick growth opportunities after the launch of Nasodine For personal use only Expand indication to adolescents (12-17) and prevention of colds Expand usage to hospitals (e.g., MRSA nasal decolonisation, CRS) Pandemic opportunity: Readout of Phase 2 trial in COVID-19 New product development: prod
Slide 18: 2023 potential catalysts for FRE
2023 potential catalysts for FRE For personal use only Earliest Outcomes Comments and caveats potential date Conciliation meeting date is 30 May but could move or AAT appeal and • Conciliation meeting outcome • Jun have no substantive outcome; AAT Hearing may be required causing delays; if appeal pr
Slide 19: Firebrick is different to most biotech firms
Firebrick is different to most biotech firms For personal use only Firebrick Pharma Drug development biotech (DDB) Australian launch, then launch globally Achieve clinical milestones towards a Big Value creation through distribution partnerships Pharma licensing deal or trade sale strategy Goal is t
Slide 20: Firebrick Pharma Limited
For personal use only ASX: FRE 20 FIREBRICK PHARMA LIMITED
Firebrick Pharma — Euroz Hartleys Healthcare Forum 2023 on 6ix