Analyst Report by Euroz Hartleys – 01 February 2023

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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

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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

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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

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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

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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

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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.

SPP Now Open

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Botanix’s recently announced Share Purchase Plan (SPP) to raise up to A$3 million is now open for eligible AU/NZ shareholders.

The SPP opens today, 9 November 2022 and will remain open until 8:00pm AEDT on Wednesday, 23 November 2022 (unless extended or withdrawn). 

As the SPP is only open for two weeks, eligible shareholders are encouraged to apply for new shares as soon as possible.

Click here to read today’s ASX release.

A$5 million strategic Placement + Share Purchase Plan

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Botanix (ASX:BOT) has today lifted its trading halt, sharing news that it has secured a commitment of A$5.0million from a highly respected institutional investor, Antares Capital. The Company will also offer a limited Share Purchase Plan (SPP) for eligible AU and NZ shareholders to raise up to A$3 million.

Click here to read today’s ASX release.

Significant R&D Tax Incentive Refund

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Botanix has today announced it has received a Research and Development (R&D) Tax Incentive Refund of A$3,669,439 for the 2021/2022 financial year.

Click here to read today’s ASX release.

Promotion of Dr Howie McKibbon to Chief Operating Officer

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

Howie has more than 20 years of leadership experience in the pharmaceutical industry. He has launched 15 products including 11 in dermatology, and managed over 30 dermatology products. Importantly too, he played a significant role in two of the world’s largest dermatology acquisitions with combined valuations of $7.8 billion. 

Howie’s role will be expanded to include responsibility for all commercial, manufacturing, medical affairs and regulatory activities. We believe the breadth and depth of his experience will be invaluable as the Company prepares for FDA mid-cycle review of our lead asset, Sofpironium Bromide in late Q1 2023.  

Click here to read today’s ASX release.