Investor Webinar Replay | 26 September 2023

Botanix (ASX: BOT) has received a communication from FDA in relation to its NDA submission for Sofpironium Bromide gel, 15% (SB) for the treatment of primary axillary hyperhidrosis.

Encouragingly, no clinical efficacy, safety or manufacturing issues were raised and no additional clinical studies are required by the FDA to support approval. We will be revising the printed Instructions for Use document proposed for inclusion with the product and our team is now focused on working with the FDA to address the points raised, with plans to resubmit the NDA for SB by 1Q CY24 and targeting approval for mid-CY24.

Earlier today Botanix hosted an investor webinar outlining details of the Response Letter from the FDA – and next steps for approval. The team was joined by Mr Dave Clissold, Director of Hyman, Phelps & McNamara – the largest dedicated FDA law firm in the United States advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory matters.

Dr Howie McKibbon appointed Chief Executive Officer

Botanix has announced the promotion of Dr Howie McKibbon to the role of Chief Executive Officer, from his current position as Chief Operating Officer.

Dr McKibbon was also previously Botanix’s Chief Commercial Officer, and brings over 25 years of experience in the pharmaceutical industry to the role. Over the course of his career Dr McKibbon has launched more than 15 branded products, managed over 30 dermatology products, and played a significant role in two of the largest dermatology acquisitions with combined valuations of US$7.8 billion.

Botanix Executive Chairman, Vince Ippolito said:

“I am very pleased to congratulate Howie on his promotion to CEO … His experience and proven track record of success is unsurpassed in medical dermatology and I look forward to working with him in his new role at Botanix.”

FDA review of Sofpironium Bromide remains on track, with approval targeted for the end of September 2023.

Click here to read today’s ASX release.

Bioshares Summit

Botanix is joining the biotech investment community at the 17th Bioshares Biotech Summit in Hobart this week.

This year’s theme is ‘partnering and financing’, and Botanix Executive Director, Matt Callahan, will be sharing insights into the Company’s progress navigating towards FDA approval for Sofpironium Bromide.

Click here to review the presentation.

The West Australian | Botanix Pharmaceuticals secures $12.5m via an institutional placement

Botanix has been featured in an article by Cheyanne Enciso in The West Australian newspaper, reporting on its A$12.5 million raise via an institutional placement.

Read the article here.

A$12.5 million institutional placement

Botanix has announced it has secured firm commitments for A$12.5 million via an institutional placement.

Proceeds from this raise will be used to extinguish future milestone and royalty payments linked to Botanix’s lead product, Sofpironium Bromide (SB) – in a move that could save up to $160 million and prime the Company for potential M&A or partnership activity.

Click here to read ASX release.

Video | Investor Webinar

Botanix (ASX: BOT) hosted a webinar recently to update investors on the Company’s progress during the FDA review period for its lead product, Sofpironium Bromide.

The webinar was hosted by Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon.

Take a look.

New territory licensed for Sofpironium Bromide with partner Kaken

Botanix has today announced that our partner Kaken Pharmaceutical Co Ltd, has secured a new sublicense and distribution agreement for Sofpironium Bromide in Korea.

The deal with Dong Wha Pharmaceuticals, Korea’s oldest pharmaceutical company, will see the expansion of Sofpironium Bromide into the Korean market. Sofpironium Bromide has been successfully marketed as ECCLOCK® by sublicensee Kaken in Japan since November 2020.

Under the terms of this agreement, Botanix will be entitled to a share of the upfront, milestone and royalty payments based on net sales of the products.

Botanix Executive Chairman, Vince Ippolito, said:
“We are very pleased with the progress being made by our partner Kaken in expanding the territories for Sofpironium Bromide commercialisation globally.

“Given the global incidence of primary axillary hyperhidrosis and the relative lack of effective solutions for patients, the opportunities for Sofpironium Bromide continue to expand beyond Botanix’s primary focus of the USA with our existing partner Kaken and new partners to come.”

Click here to view ASX release.

Investor Webinar Invitation

Botanix (ASX: BOT) is preparing to host an upcoming investor webinar on Wednesday 07/06/23, 10:30am AEST | 8:30am AWST.

On this call, you will hear from Executive Director, Matt Callahan and Chief Operating Officer, Howie McKibbon. Together, they will be sharing an update on our progress during the current FDA-review stage for our lead product Sofpironium Bromide.

Click here to pre-register now to secure your place.

Analyst Report | 6 April 2023

Euroz Hartleys has published an analyst note, reporting on the successful completion of Botanix’s FDA mid-cycle review meeting for Sofpironium Bromide, as well as the Company’s recent capital raise.

Analyst Seth Lizée noted that $BOT remains considerably undervalued in comparison to its peers approaching an imminent FDA approval decision and soli data supporting commercial success.

He wrote:

“Importantly, what splits BOT apart from some of its peers, is its capacity to go-to-market and execute on a commercial strategy in house. This places BOT in a significantly stronger negotiating position, as the company is not dependent on securing a licensing agreement or selling the asset to an external party.”

Read the full report

Botanix secures commitments for A $10 million via institutional placement

Botanix lifted a trading halt this morning, sharing news that it has secured commitments of
A$10.0million via institutional investors to accelerate the marketing and launch activities for
Sofpironium Bromide.

Proceeds from the Placement will be used to progress Botanix’s lead development
program, Sofpironium Bromide gel (15%), including costs associated with completing
FDA review, manufacturing, satisfying milestone payments and preparing for commercial
launch in the United States, as well as general working capital purposes and costs of the offer.

Botanix Executive Chairman, Vince Ippolito, commented:
“We are very pleased to announce this placement to institutional investors who have
actively researched and engaged with Botanix and are prepared to invest at this pivotal point in
the Company’s development.

“We are particularly pleased by the support from new institutional investors as they take
the opportunity to join Botanix on its journey towards FDA approval and
commercialisation of our lead product, Sofpironium Bromide for primary axillary

Click here to read today’s ASX release.