Investor Webinar | March 2023

Botanix (ASX: BOT) hosted a webinar to update shareholders on the Company’s preparations for the FDA mid-cycle review of Sofpironium Bromide in Q1 2023.

The webinar was hosted by Gautam Aggarwal, a Partner with Triangle Insights Group, who has conducted insightful market research in relation to the Sofpironium Bromide.

Other presenters included Botanix Executive Director, Matt Callahan and Botanix Chief Operating Officer, Dr Howie McKibbon.

Special Report | Stockhead

Botanix has today appeared in Stockhead in an article titled, ‘As it awaits crucial FDA approval Botanix reckons Aussies have a penchant for backing high-risk companies.’

This special report explores the appetite for Australian investors to back companies with a high risk to reward ratio, and why Botanix stands out as a stock to watch as we move towards the mid cycle review milestone with the Food and Drug Administration (FDA) for our lead product, Sofpironium Bromide.

Botanix COO, Dr Howie McKibbon, has extensive experience at this stage of the biotech race and is quoted in the article:

“The drug has already been launched by our partner in Japan in 2020 and the reaction there has been great, so we are now very busy implementing a full-scale commercialisation

strategy, pending a final FDA approval in Q3 this year.’’

Click here to read the article.

Botanix co-founder says interest for sweat-stopper gel is keeping him bullish ahead of FDA review | The West Australian

Botanix’s co-founder and Executive Director, Matt Callahan, was featured in a story in The West Australian newspaper by business reporter Cheyanne Encisco.

The article highlighted the FDA’s upcoming mid-cycle review of Botanix’s application for its lead product, Sofpironium Bromide gel, for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating.

In the article, Mr Callahan spoke confidently of the imminent mid-cycle review, and that a positive outcome would substantially de-risk the probability of approval.

“We’re very confident going into this review, given all the work that we’ve done, that we’ve ticked all the boxes,” Mr Callahan said.

Read the article

This broker says Botanix Pharma’s share price could more than triple on an FDA approval | Stockhead

A recent analyst report by Euroz Hartleys predicting significant upside for Botanix if the Company’s Sofpironium Bromide New Drug Application (NDA) is successful, has been featured on Stockhead.

Journalist Eddy Sunarto highlighted the analyst’s prediction that the share price could triple if FDA approval for the treatment of primary axillary hyperhidrosis is achieved in Q3 of this year.

Read the full article.

Analyst Report by Euroz Hartleys – 01 February 2023

Euroz Hartleys has published an analyst note, reporting that the mid-cycle review for Botanix’s FDA New Drug Application (NDA) for Sofpironium Bromide remains on track for this quarter (Q1 CY23).

Analyst Seth Lizée noted the experience of the Botanix team in securing FDA-approval, and successfully commercialising over 30 products. He classified Botanix as a ‘Speculative Buy, Target Price $0.27’, commenting:

“We believe Sofpironium Bromide could potentially do A$130m of sales in the USA within its first year based on the number of prescriptions the drug is currently doing through its partner in Japan, a country which has a population nearly a third the size of the USA.”

Read the full report

Quarterly Activities Report and 4C Quarterly Cash Flow Report

Botanix (ASX:BOT) has today published its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 December 2022.

Key highlights from this period include:

  • FDA accepted NDA filing for Sofpironium Bromide as sufficiently complete for a substantive review
  • FDA confirmed that a mid-cycle review of the NDA is planned for 1Q 2023
  • Independent market research project completed by Triangle Insights confirms significant revenue opportunity for Sofpironium Bromide and positive feedback from key physician, payer (insurance) and patient stakeholders, who were surveyed on a blinded basis
  • Successfully raised $5.96M via a placement to institutional shareholder Antares Capital and Shareholder Purchase Plan to existing holders
  • Successful Phase 1b/2 clinical study for BTX 1702 in rosacea completed
  • Cash position of $8.72 million at quarter end, with pivotal Sofpironium Bromide mid-cycle review meeting due this quarter

Click here to read today’s ASX release

BOT Video | Not To Be Missed

Botanix has united three experts to explain why its lead product, Sofpironium Bromide, is on track to define the success of Botanix this quarter.

Hear from one of the world’s most highly experienced dermatology specialists, former head of the American Academy of Dermatology and Founding President of the International Hyperhidrosis Society, Prof. David Pariser; together with Triangle Insights Group Partner and respected markets commentator, Gautam Aggarwal; and Botanix Chief Operating Officer, Dr. Howie McKibbon.

Together, they explain the scope of the market opportunity that Botanix is chasing for Sofpironium Bromide and how this product could positively impact peoples’ lives.

JP Morgan Healthcare Conference Presentation

Botanix will be attending the JP Morgan Healthcare Conference in San Francisco this week. The conference attracts more than 50,000 attendees from around the world, bringing together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

As part of the conference, Botanix will be discussing the significant commercial potential of Sofpironium Bromide and sharing some of the independent market research recently completed by Triangle Insights.

With the formal filing of the Sofpironium Bromide NDA now accepted by FDA and a standard review period confirmed, we are pleased to report that the mid-cycle review remains on track for this quarter.

Click here to view the presentation.

Research Report by Euroz Hartleys – 8 December 2022

Botanix is pleased to share an analyst report published by Euroz Hartleys following this week’s announcement that our Company has received formal written communication from the FDA, confirming that our New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.

Analyst Seth Lizee classified the Company as a ‘Speculative Buy, $0.27 Price Target’, and commented on this achievement:

“Overall, we view this is as yet another milestone met, bringing BOT one step closer to potential FDA approval, and in time commercialisation.”

Read the full report.

FDA confirmation Sofpironium Bromide NDA is formally under review

Botanix has today announced that it has received formal written communication from the FDA, confirming that the New Drug Application (NDA) for Sofpironium Bromide is suitable for substantive review, and that no issues have been identified.

With the NDA now formally under review, and a standard review period confirmed, Sofpironium Bromide remains on track for approval in 3Q, 2023.

Botanix President and Executive Chair, Vince Ippolito, said:

“We are very pleased that the NDA for Sofprionium Bromide has been accepted for substantive review by the FDA. Our team has worked diligently to file a comprehensive application and we look forward to the anticipated mid-cycle review in 1Q 2023 and the ultimate approval of Sofprionium Bromide.”

Click here to view ASX release.