Under its old business model, the number 4 would typically never be marketed to their major customers but under the new direction of infant formula company Bubs Australia (ASX: BUB), its a joyous occasion with the 400th infant enrolled in their clinical trial program which seeks regulatory approval for commercial sales in the United States.
The 400th infant enrolled in its Growth Monitoring Study (GMS) is a vital milestone as part of the clinical trials mandated by the US Food and Drug Administration (FDA). This enrollment comes as Bubs aims to transition from temporary to permanent market access by October 2025, allowing the company to sell its infant formula products in the US on a long-term basis.
The GMS trial is an essential regulatory step, involving a nationwide study of healthy, full-term infants who are consuming Bubs’ various formulas, including Goat Milk and two Cow Milk products. The trial aims to assess the growth, tolerance, and safety of the formulas, with monitoring conducted by healthcare professionals at designated clinical sites. Parents and caregivers also contribute input to ensure a comprehensive evaluation.
Unlike many clinical trials involving young children, Bubs’ approach stands out for its ethical considerations and rigorous oversight. The trial is led by Dr. Keith Aqua, an obstetrics and gynaecology expert with experience in over 350 clinical trials. Bubs’ focus on healthy infants, combined with its use of a commercially available formula as a control group and a breast-feeding cohort for reference, sets this study apart from other clinical trials that often raise concerns about the safety of testing on such young participants.
The milestone comes at a pivotal time for Bubs, which first entered the US market in May 2022, during a nationwide infant formula shortage. Bubs was quick to offer assistance through the US. government’s ‘Operation Fly Formula’ program, becoming the second company worldwide to be granted temporary enforcement discretion to sell its products in America. Since then, Bubs has worked steadily to build a relationship with US parents, caregivers, and healthcare professionals.
For Bubs, the US market represents both a major opportunity and a challenge. After a few turbulent years, including market disruptions, leadership changes and financial struggles, securing permanent access to the US market would mark a significant turning point. Success would allow Bubs to compete more effectively against major players in a highly competitive market and help mitigate the company’s past struggles in its home markets and abroad.
“With our 400th infant now enrolled in the study, Bubs can finalise and submit the necessary data to the FDA in what is a critical step towards achieving permanent market access,” said Bubs Chief Operating Officer, Richard Paine.
“We are pleased to have finalised patient enrolment in a significant study involving three distinct Bubs Infant Formulas,
Bubs anticipates final FDA approval by October 2025.
For FY24, Bubs reported revenue of $79.7m which represented a 33% increase on the previous year. Notably, revenue from US sales of $35 million was a 46% increase on the previous year making a turning point in Bubs previous reliance on sales to China which generated $17.3 million for comparison.
Despite these revenue gains, Bubs still declared a statutory net loss of $20.9 million, albeit a substantial improvement on the $108.4 million loss reported in FY23.
Alfred Chan is a Business Reporter at The Sentiment specialising in ASX-listed small cap companies, bloodstock enthusiast and former Analyst.
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