Biocurious: No sweat as Botanix tackles the world’s third-biggest skin disorder

Botanix has FDA approval for its treatment for hyperhidrosis, or excessive sweating
Sufferers have not had an effective treatment for the socially debilitating disorder
Broker E&P Financial Group estimates revenues of close to $100 million within 12 months of launch

Imagine sweating profusely at the most awkward of times, to the degree that the embarrassing saline liquid can even seep through an overcoat.

That’s experience of sufferers of hyperhidrosis, who sweat far beyond the normal imperative to regulate body heat. Remedies to date include an extra dash of Old Spice, living in a colder climate or staying home.

The nerve-settling Botox is also used.

“They are silent suffers,” says Botanix Pharmaceuticals (ASX:BOT) chief Dr Howie McKibbon. “They plan their day around when they think it will happen and go out as little as possible.”

Hyperhidrosis is the world’s third-biggest skin disorder with around 16 million sufferers globally – about 10 million of them actually diagnosed – behind only acne (40-50 million) and atopic dermatitis (20-25 million).

Luck’s a fortune

Through a combination of opportunism and good luck, Botanix latched on to the opportunity and in June the US Food & Drug Administration (FDA) approved its topical treatment called Sofdra (sofpironium bromide).

The company back-door listed in July 2016 on the back of its synthetic cannabinoid treatments for skin diseases including acne, atopic dermatitis and psoriasis.

But progress was slow and in 2022 the company acquired Sofdra from the cash-strapped Nasdaq-listed Brickell Biotech, now Fresh Tracks Therapeutics.

The price – an upfront US$4 million plus various other milestones and royalties – hardly reflected the US$120 million Brickell had invested to get the drug beyond phase III.

“It was during Covid and they basically ran out of money, which was their loss and our benefit,” Callahan says.

In a further case of masterful timing, Botanix in June last year bought back up to US$172 million of potential milestones and royalties payable to Fresh Tracks, for a mere US$8.25 million.

Kissing frogs pays dividends

Callahan says Botanix was angling for the bigger indications of acne and rosacea and it still has programs for these indications.

“But the timing to market was going to be a few years, so we wondered if we could get to market quicker by acquiring a product closer to approval,” he says.

“We kissed a lot of frogs by looking at more than 30 products. We were looking for something with a big market and which could be diagnosed without blood tests.

“We also wanted something without any other treatment and hyperhidrosis met all those criteria perfectly.”

The FDA approval is for primary axillary hyperhidrosis (PAH) – underarm sweating, the other forms being palm, feet, back, face and even breasts – anywhere where there’s skin.

PAH accounts for about seven million of the ten million diagnosed hyperhidrosis cases.

Serving an unmet need

Callahan says there might be 25 oncology drugs for a particular form of cancer, but there’s virtually nothing for hyperhidrosis.

“You don’t get many markets where there are 10 million people and there are no really good products with a massive unmet need,” he says.

Botanix told shareholders at last week’s AGM it was in the process of a ‘soft’ US launch, availing on a subset of patients on the International Hyperhidrosis Society (HIS) database.

“We will give them the opportunity to try the product and work through our telehealth system and then expand it into the whole hyperhidrosis database,” says Botanix executive chair Vince Ippolito.

“We will then put sales reps on the street at the end of January to get into the dermatologists offices.”

‘Frustrated’ dermatologists want something better

The US Sofdra launch is made easier because a mere 4500 dermatologists write 90% of the prescriptions – and they are screaming for solutions.

The company won’t forecast revenues but is comfortable with broker E&P’s estimate of $96 million within 12 months of launch.

Current reimbursement guidelines should cover the costs to the patients.

Callahan says Botanix’s revenue run rate will become apparent within 12 months from launch, but an initial 20-30% market share looks reasonable.

“We know 3.5 million [patients] have had a diagnosis in the last 12 months, so if we can get 20-30% penetration that is a massive number.”

Cashed up and ready to go

Post the FDA approval Botanix went to market for $70 million in an institutional placement.

These funds should be enough to fund the launch – which doesn’t come cheaply – with breakeven expected “some time in the future”.

Don’t paint yourself into a corner there, lads!

Meanwhile, the company’s rosacea and acne treatments are on ‘care and maintenance’ and management needs to decide whether to use the hyperhidrosis revenue on clinical trials to build a second product.

Botanix is eyeing expansion in other countries where it can leverage FDA approval, including Canada, Australia and New Zealand.

The company is also interested in countries with greater “aesthetic orientation”, notably the populous and body-beautiful Brazil.

Management’s knowledge is more than skin deep

Botanix’s street cred is enhanced by the experience of key management in developing other approved drugs – 30 in all.

Ippolito was chief commercial officer with the Nasdaq-listed inflammatory diseases house Anacor – the world’s biggest independent skin diseases house which Pfizer acquired for US$5.2 billion in 2016.

“We had a bunch of nice drugs but the primary reason Pfizer bought us was for the platform we built, which is a modified and enhanced version of the platform we acquired.”

McKibbon was formerly a vice president at Dermavant Sciences and held senior positions at Anacor and Medicis.

Callahan, meanwhile, co-founded the ASX-listed Orthocell and Dimerix.