Last week, Telix Pharmaceuticals (TLX: $29.22) announced it has gained approval for the first of its three new diagnostic applications with the FDA this year.
This first win has been for Gozellix, which is a next-generation product for in vivo prostate cancer detection. It will be sold alongside Illuccix, which is the company's current flagship product. Gozellix has a 50% longer shelf life than Illuccix (six hours versus four hours), with a larger distribution radius to render it more available.
Clinicians will use Gozellix and Illuccix to image prostate cancer for three reasons. Firstly, to detect metastases. Secondly, to image for recurrence. And thirdly, to select patients for radiotherapy (with Pluvicto, from Novartis).
The next products for review by the FDA are Pixclara (by 26 April) for imaging brain cancer lesions, and Zircaix for kidney tumour imaging (by 27 August). Zircaix is Telix's key milestone for 2025, given the potential for this diagnostic drug to match or exceed Illuccix sales.
Telix is forecasting sales this calendar year of A$1.2 billion for Illuccix alone, up 50% on last year. Its profit after tax was $49.9 million last year, after spending $195 million on R&D. It finished last year with $710 million in cash, and enjoys a capitalisation is $9.8 billion.
Bioshares recommendation: Hold
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