Final Sofdra™ Labelling Discussions with FDA

Botanix has submitted the last label materials to the US Food & Drug Administration (FDA) for Sofdra™ a pending prescription treatment for excessive underarm sweating. Label discussions are the final step for Botanix before the anticipated FDA approval of Sofdra and have involved product carton design and wording of information that is provided to patients and physicians about the product.

Click here to view ASX release.

“Compelling Opportunity” | E&P Research Report

In new research on Botanix, leading biotech analyst David Nayagam from E&P highlights the “compelling opportunity” that the Company presents and initiates coverage with a speculative buy and $0.55 price target. This increased interest in Botanix comes at a critical time, as we await the commencement of labelling discussions with the FDA – the final regulatory hurdle for Sofdra™ before expected approval in late June 2024.

View E&P Report.

Euroz Hartleys Analysis | Commercial Day Webinar

Euroz Hartleys’ Seth Lizee reviews the Botanix Commercial Day Webinar and maintains a Speculative Buy recommendation with an upgraded $0.33 Price Target.

Lizee expressed increased confidence in the late June FDA approval decision and BOT’s commercial strategy.

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Video Available | Commercial Day Webinar

Video is now available of the Company’s Commercial Day Webinar presented on 8 May.

The expanded commercial team provides market insights and a comprehensive update on commercial launch plans for Sofdra™, which is expected to be approved in late June 2024.

Botanix Included in the All Ordinaries Index

Botanix Pharmaceuticals (ASX:BOT) is honoured to announce the Company’s inclusion in the ASX All Ordinaries Index. Botanix joins the ranks of the index, based on its strong performance over the last 12 months.

Botanix Chief Executive Officer, Howie McKibbon, commented: “We are humbled to acknowledge the confidence investors have shown in our company, as exemplified by our inclusion in the ASX All Ordinaries Index.”

The performance of Botanix shares has been driven by interest in the Company’s Sofpironium Bromide gel, Sofdra™, which is a topical treatment for excessive underarm sweating that is expected to receive approval from the US FDA in late June. Botanix launch preparations are well underway.

Click here to read today’s ASX release.

The West Australian | Botanix co-founder Matt Callahan says zig-zag career like ‘drinking from a firehose’

Botanix co-founder and executive director Matt Callahan has been profiled in The West Australian this week, in an article by journalist Cheyanne Enciso titled “Botanix co-founder Matt Callahan says zig-zag career like ‘drinking from a firehose’ “.

The feature outlines Matt’s extensive experience as founder of several ASX-listed companies, and shares his insights into what makes a successful company.

I think the strongest lesson for me is to work with people who are world class and be prepared to learn from them, be prepared to build networks with people that ultimately can create a great company.”

Click here to read the article.

Botanix appoints Graeme Morissey CFO

Botanix Pharmaceuticals (ASX:BOT) is pleased to announce the appointment of Graeme Morissey as Chief Financial Officer (“CFO”) of the Company effective 25 March 2024. Mr Morissey joins Botanix as a proven CFO with over 17 years’ experience with senior roles at international accounting firms including Grant Thornton in Canada and Australia, as well as KPMG Australia and EY Australia. Graeme has worked with more than 40 ASX listed companies supporting audit and other financial functions and most recently has occupied CFO positions at a number of ASX listed companies.

Mr Morrisey joins Botanix at an important time for the company as it prepares for commercial launch of Sofdra™ early in 3Q CY2024 following anticipated approval of the product in late June. As the commercial team accelerates activities focused on sales and marketing operations, reporting and tax planning, Graeme’s wealth of experience will be important to help coordinate Australian and US reporting and compliance.

Click here to read today’s ASX release.

Botanix to Present at Euroz Hartleys Institutional Conference

Botanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO Dr Howie McKibbon will be among the featured presenters tomorrow at the annual Euroz Hartleys Institutional Conference being held March 12–14 on Rottnest Island. Also participating from Botanix is Executive Chairman Vince Ippolito who will take part in a panel discussion with Australia-based life science companies.

The Conference brings together institutional and sophisticated investors from around Australia and internationally to showcase small to mid-cap companies with a Western Australian focus. Botanix will provide an update on progress towards commercialisation of Sofdra™, which remains on track for FDA approval in late June 2024, as launch readiness activities accelerate.

Click here to read today’s ASX release.

Euroz Hartleys Healthcare Forum Presentation

Botanix Pharmaceuticals (ASX:BOT) announced that Botanix CEO, Dr Howie McKibbon, is presenting at the Euroz Hartleys Healthcare Forum being held today in Perth, Western Australia.

The Conference brings together some of Australia’s leading listed and private healthcare companies, as well as institutional investors from around Australia and the region. Botanix will be outlining the significant commercial potential of Sofdra and sharing some of the launch preparation activities that are currently scaling up in anticipation of FDA approval which is targeted for late June 2024. 

Click here to read today’s ASX release.