4D Medical’s US Breakthrough, Clinuvel’s Global Push, and Biome’s Revenue Surge

Highlights 

• 4D Medical expects its first revenue from a US distribution deal with Philips this year.
• Clinuvel Pharmaceuticals seeks Canadian approval for its skin disorder drug Scenesse.
• Biome Australia reports record revenue growth in the latest quarter.

4D Medical (ASX:4DX)

4D Medical is set to generate its first revenue from a major US distribution deal with Philips, targeting the lucrative lung imaging market. The agreement, announced recently, grants Philips exclusive distribution rights to US government contracts for five years, and non-exclusive rights for other scans. With an estimated annual US$300 million revenue opportunity from 12 million lung scans, 4D Medical is poised to tap into a segment of the US$30 billion global lung imaging market.

This partnership aims to address respiratory diseases affecting US veterans, a significant concern due to conditions like constrictive bronchiolitis, which current diagnostic tools cannot detect. The company’s CT Lung Ventilation Analysis Software (LVAS) is positioned to improve diagnostic accuracy and patient outcomes, with scans reimbursed under the US Medicare/Medicaid system. 4D Medical’s share of this market could grow as it aims for broader adoption, with projections indicating $18.2 million in revenue for the current year, increasing to $94 million by 2026-27.

Clinuvel Pharmaceuticals (ASX:CUV)

Clinuvel Pharmaceuticals continues its global expansion efforts by seeking Health Canada approval for its flagship drug Scenesse, used to treat erythropoietic protoporphyria (EPP), a rare genetic disorder causing sun intolerance. Scenesse, which has already been approved in the US and European Union, generated $95 million in revenue last year, mostly from US sales. Despite this growth, Clinuvel shares have declined 10% over the past six months, even though the company posted a net profit of $35 million.

With approximately 280 EPP patients in Canada, some have already received treatment under a special access scheme, potentially paving the way for broader adoption if Health Canada grants approval. Clinuvel also seeks to expand Scenesse’s use for other skin disorders, such as vitiligo, as it aims to further grow revenue beyond the US market.

Biome Australia’s (ASX:BIO)

Biome Australia, a supplier of probiotic supplements, reported strong growth for the September quarter, with unaudited revenue reaching $4.25 million, a 55% increase from the same period last year. The company’s annualized revenue now sits at $17 million, as it continues to expand its market presence. 

Biome Australia has ambitious plans to nearly quadruple its revenue to $75-85 million over the next three years, a significant leap from the $22.5 million in cumulative revenue over the last three years. The company’s rapid growth highlights its success in the probiotics market and sets the stage for continued momentum in the coming quarters.