A quick interview here with Matt Callahan published yesterday:

https://www.sharecafe.com.au/2025/03/12/botanix-transforming-dermatology/

BOT paid for this interview/advert

Howie says: 1.8 fills per patient per year is typical refill rate for dermatological products in the US. BOT aims to get that to 7-12 fills per year for SOFDRA.

There's nothing new here. Howie remains consistent and on message.

https://stockhead.com.au/health/long-shortz-with-botanix-pharmaceuticals-a-new-major-milestone/

Stockhead’s Tylah Tully chats with  Botanix Pharmaceuticals (ASX:BOT) CEO Dr Howie McKibbon, to get the short end of the long story on the company’s latest news.

Botanix has recently been included in the ASX 300, which is part of the company’s focus to be the world’s largest and most innovative dermatology company.

Tune in as Howie discusses this new milestone and hear more about their next planned phase for the treatment of primary axillary hyperhydrosis.

This video was developed in collaboration with Botanix Pharmaceuticals, a Stockhead advertiser at the time of publishing.

BOT has this morning released its Appendix 4D and Half year Report

I am running around doing other things just now and havent had a serious look at the numbers.

However one thing that is for me a glaring omission is the results of the PEP.

I was hoping for some figures pertaining to the program conducted with the Hyper Hydrosis society.

I can only assume it was not impressive.

Given that the PEP was essentially preaching to the converted, I find it concerning that we have no numbers around this at all.

Am I being ridiculous?

Announcement out today: https://investorpa.com/announcement-pdf/20250117/91967.pdf

He's got to sell down 12.2% of his holdings to pay a tax bill.

I hope it doesnt spook the market too much

Nature of change

Example: on-market trade, off-market trade, exercise of options, issue of securities under dividend reinvestment plan, participation in buy-back

Executive Chair Vince Ippolito recently exercised 8,000,000 Performance Rights (expiring 2 December 2029) into 8,000,000 fully paid ordinary shares and has subsequently sold 3,800,000 fully paid ordinary shares on-market. These transactions have allowed Mr Ippolito to increase his holding in the Company to 15,001,644 fully paid ordinary shares whilst funding the tax obligations for the exercise of the 8,000,000 Performance Rights. The sale of 3,800,000 fully paid ordinary shares represents approximately 12.2% of Mr Ippolito’s fully diluted holding in the Company (including a total of 16,000,000 Performance Rights expiring 2 December 2029).

Mr Ippolito has no plans to sell any additional shares in the medium term other than to satisfy any tax obligations.

Mr Ippolito remains firmly committed to leading Botanix Pharmaceuticals Ltd as the Company transitions into a revenue generating commercial stage pharmaceutical company.

BOT @ Lytham Partners 2025 Investor Healthcare Summit

Matt Callahan talks shop Click here

I didn't garner any ground breaking news from this, however:

Matt discussed the companies "social listening program" which has identified 435,000 HH sufferers discussing HH and its affects on their lives. This snooping in on conversations on social media platforms allows the company to Id potential future customers, put information in front of them and funnel them through to the Telehealth platform. This can be done right at the time that the HH sufferer is looking for information.

It is possible to be made aware of Sofdra, get diagnosed, then have Sofdra shipped and at your door all within 48 hours. As opposed to getting a referral to a Dermatologist via a GP and picking up Sofdra from the Pharmacy, a process that could take months.

While Sofdra was obviously a big focus right now, Matt highlighted the value in the development of the platform.

It seems that Vince is being paid some of his performance rights Click here for announcement

While this is a milestone, decent sales figures are surely what will move the dial. I am supposing that at this point, the stage is being set and while there may be a handful of sales, its probably not that impressive just yet.

It would be nice if they outlined exactly what rights they were. I guess these, as per the AGM:

Someone has started a Facebook group dedicated to BOT as an investment. It's early days. Seems to have started a few days ago. Currently 77 members. It may throw up some interesting discussion, or not. I'll keep an eye out. Nothing to report thus far.

This group is created for Botanix investors or other that can contribute with their expertise in reading report, news or have an interest in Botanix future research! No spamming is allowed, if you want to post give valuable information that is useful for the group members

Botanix Pharmaceuticals (BOT) | Bell Potter Healthcare Conference 2024

Matthew Callahan, Executive Director at Botanix Pharmaceuticals (BOT) presents at the Bell Potter Healthcare Conference 2024.

https://www.youtube.com/watch?v=Yqp8Fbq_2pg

Hiring of sales force team - on track

Telehealth platform (Upscript) - In place and on track

"Payer success continues" (Insurance companies signing/signed up. By all accounts a long and time consuming process. Very important in the scheme of things as it will bring the cost of SOFDRA to zero, for the insured Hyperhidrosis sufferer.

❖ Contracts already signed or currently being signed with Commercial Payers that represent

~80M commercial lives

❖ Finalizing terms on contracts with Commercial Payers representing a further ~80M lives in

the coming weeks

❖ On track to have ~72M Medicaid lives eligible

❖ Contracts signed and being negotiated reflect the expected Payer coverage mix (see chart

previous slide)

❖ Where there are Payer restrictions, those restrictions only limited to those negotiated:

− ensuring that the patient actually has the medical condition per the label; and/or

− the patient confirms they’ve tried an existing product such as Drysol

Patient experience program - On track

Manufacturing - On track

Nb. diagram below refers to the calendar year:

There is not much here that has not been communicated previously.

All in all this is playing out as planned

As discussed here on SM previously, there may not be too much to get excited about until the new calendar year and some sales data from the US, begins to trickle in.

Meanwhile its steady as she goes and stick to the plan/timeline below:

https://investorpa.com/announcement-pdf/20241104/62789.pdf

Botanix Pharmaceuticals Quarterly Activity Report and 4C Quarterly Cash Flow Report

Key highlights

• Botanix is on track to launch its patient experience program in Q4 CY2024
• Botanix has finalised contractual arrangements with a number of key US payers (insurers) which reflect the target financial and patient access restrictions previously communicated, with
• further contracts to be signed in coming months
• Botanix has filled key positions in sales, marketing, sales training and sales operations that will
• support the commercialization of Sofdra
• In September Botanix was featured in both the ASX Small and Mid-Cap Conference and the E&P
• Small Cap Healthcare Conference in concert with a non-deal roadshow
• Cash position of A$67.62 million at September 2024 quarter end with no debt

Full Ann click here

At a glance there is nothing exciting here, but that's fine. Seems to be on track. In line with the plan.

Staff hired and rolling on toward sales in the new calendar year.

Steady as she goes.

Hiring announcement out this morning Click here

At first glance they seem to be hiring some decent talent, who have runs on the board.

The hiring of John Walsh for example is to some extent getting the band back together:

• John Walsh – Vice President, Sales – Mr Walsh was most recently Regional Business Director for Dermavant Sciences (a company previously managed by Mr Ippolito and Botanix CEO Dr Howie McKibbon, which was sold to Organon for up to $1.2 billion recently). Mr Walsh has held senior sales roles with a variety of leading dermatology focused companies including with Anacor and Pfizer.

It seems to this layman that this is a team who have been here before.

Here's Howie again at the small and mid cap conference. He does mention an AI driven marketing campaign - that's got to be a good thing right?

Botanix with Proactive at ASX Small and Mid Cap Conference

Botanix Ltd CEO Dr Howie McKibbon sits down with Proactive's Tylah Tully live from the ASX Small and Mid Cap Conference in September 2024.

https://www.proactiveinvestors.com.au/companies/news/1056845/botanix-with-proactive-at-asx-small-and-mid-cap-conference-1056845.html

BOT CEO Howie McKibbon - interview

https://ausbiz.com.au/media/botanix-sweating-on-sofdra-launch?videoId=37991

From Stockhead: Click here

Alive and Kicking: No sweat as Botanix readies for US launch of its hyperhidrosis treatment

Health & Biotech

 Tim Boreham

Alive and Kicking is renowned biotech journo Tim Boreham’s new daily wrap covering morning movers and shakers of note in the ASX Healthcare sector, Monday through Thursday.

• Botanix plans a US launch of its anti-sweating treatment in the March 2025 quarter
• Pacific Smiles shareholders have a new offer to get their teeth into
• Bubs Australia enrols its 400th and final infant for US clinical trial

Botanix Pharmaceuticals (ASX:BOT) says it will launch its approved product for excessive sweating in the US in the March quarter of next year, targeting 10 million sufferers of the common but little-known primary axillary hyperhidrosis (PAH).

In June the US Food & Drug Administration green-lighted its topical gel Sofdra, a “novel, safe and effective solution for patients who have lacked treatment options for this socially embarrassing medical condition.”

PAH is sweating over and above what is required to regulate the body’s temperature. We’re talking about shirt-drenching sweat, not something that can be ameliorated with an extra spray of Brut 33.

It’s the third biggest dermatological condition behind acne and dermatitis.

At an investor update this morning, the company said it had recruited 500 patients via the International Hyperhidrosis Society – yes, there is such a thing – with 18,000 to follow.

Meanwhile, the company has hired 27 sales reps across three regions to kick-start the sales and is wooing the small number of physicians – 4500 or so – who prescribe PAH treatments.

The company says seven million PAH patients have been diagnosed over the past 10 years, while three million remain undiagnosed. Given the US population of 336 million, that’s an incidence rate of a not insignificant 3%.

The company stresses that Sofdra will be eligible for reimbursement, with no out of pocket costs for most patients.

Initially, Botanix focused on developing synthetic cannabinoid treatments for skin diseases including acne, atopic dermatitis and psoriasis.

But results were patchy and in May 2021 the company obtained the rights to the sofpironium bromide (renamed Sofdra).

Unlike antiperspirants, Sofdra addresses the underlying problem by suppressing underarm receptors. Technically, Sofdra works by inhibiting M3 muscarinic receptors in eccrine glands at the application site. 

Found throughout the body, these receptors induce a ‘fight or flight’ response, including sweating and salivating, lactation and even urination. 

The excessive sweating comes in three iterations: primary axillary (under the arms), cranio-facial (head and face), palmar (hands and palms) and plantar (feet). The company has FDA approval for the first. 

Initially, the FDA rebuffed the company because of concerns about the wording of instructions in the Sofdra packaging, but these issues proved surmountable. 

However the March 2025 timeline is a slippage from the originally envisaged mid-2024 launch.

Immediately after approval, Botanix raised $70 million in an institutional placement, so it is well placed to lob its first US underarm delivery.

Botanix shares closed one cent higher at 42 cents, ascribing a meaty $770 million market capitalisation.