Botanix Pharmaceuticals (BOT: $0.32) has received FDA approval for Sofdra, a prescription medicine for primary axillary hyperhidrosis (PAH), or excessive underarm sweating. It is the first novel chemical entity approved for this indication.
Following the approval, Botanix has launched a capital raise for $70 million at $0.30 per share which has been completed.
Sofdra (sofpironium bromide) was acquired by Botanix in May 2022 from Bricknell Biotech Inc. Botanix paid an upfront fee of US$3 million plus milestones, and is required to pay a royalty from product sales starting at 12% and up to 20% once sales exceed US$500 million a year. This obligation has since been extinguished with a cash payment.
Botanix stated that the global market for medical hyperhidrosis treatment is valued at US$1.4 billion a year, with the US comprising two-thirds of that market.
FDA Approval Pathway
Botanix first submitted its NDA for marketing approval in September 2022. In September last year it received a Complete Response Letter from the FDA relating to the patient instructions only. In December it met with the FDA with an agreed path forward, completed a human factors study that month. It resubmitted its NDA in December. In June it had final labelling discussions with the regulator prior to receiving approval shortly after.
Commercial Launch & Market
Botanix expects to start an early patient experience program with first revenue expected in the December quarter this year. Of the $70 million raised, $17.5 million will be used to build a direct sales force of between 20-30 people.
A further $17.5 million will be used for digital marketing and its telemedicine platform. Last month there were just under 400,000 people sharing their 'sweat stories' on social media according to the Kick Health social listening survey. According to the company, telemedicine platforms have become a mainstream tool to help the pharmaceutical industry to access patients.
In the company's Phase III study, both primary endpoints were met with highly statistically significant results.
Sofdra is sold under the name Ecclock in Japan through a licensee, having been approved in 2020. Japan has one third of the population of the US. In the last 12 months around 350,000 units were sold in Japan. Learnings from Japan will be applied to the US market. The company said that the reimbursement process was well advanced in the US.
Bioshares recommendation: Speculative Buy Class A
Disclaimer:
Information contained in this newsletter is not a complete analysis of every material fact respecting any company, industry or security. The opinions and estimates herein expressed represent the current judgement of the publisher and are subject to change. Blake Industry and Market Analysis Pty Ltd (BIMA) and any of their associates, officers or staff may have interests in securities referred to herein (Corporations Law s.849). Details contained herein have been prepared for general circulation and do not have regard to any person’s or company’s investment objectives, financial situation and particular needs. Accordingly, no recipients should rely on any recommendation (whether express or implied) contained in this document without consulting their investment adviser (Corporations Law s.851). The persons involved in or responsible for the preparation and publication of this report believe the information herein is accurate but no warranty of accuracy is given and persons seeking to rely on information provided herein should make their own independent enquiries. Details contained herein have been issued on the basis they are only for the particular person or company to whom they have been provided by Blake Industry and Market Analysis Pty Ltd. The Directors and/or associates declare interests in the following ASX Healthcare and Biotechnology sector securities: Analyst MP: 1AD, ACR, AVR, CGS, CUV, CYC, DXB, IMM, LBT, MX1, OPT, NEU, PAB, PXS,RNO,SOM. These interests can change at any time and are not additional recommendations. Holdings in stocks valued at less than $100 are not disclosed.
