Infant formula manufacturer, Bubs Australia, says its US revenue in November averaged more than $770,000 a week. Bubs is currently the number one goat milk infant formula brand in the US, with the company focused on achieving FDA long-term approval.
Bubs is ranged in more than 5900 stores across the US and in the first five months of FY24 sold 330,000 tins, compared to 400,000 tins in total for FY23.
In October, the American Academy of Pediatrics (AAP) officially expanded its infant formula recommendations to include goat milk-based products, and in July, European goat milk formula brand, Kabrita, was the first goat milk-based formula to be long-term FDA authorised.
During its recent capital raise, CEO Reg Weine said proceeds would be used to start a second production shift at its Deloraine plant in January 2024, invest in sales and marketing, and progress its FDA long-term approval.
Weine said, “The American Academy of Pediatrics (AAP) expanded their infant formula recommendations recently to include goat milk-based products for the first time which is a game changer. We are pleased to report that we have already extended our single manufacturing shift to meet the increasing demand and we will move to a full second shift at Deloraine in mid-January 2024.
“Despite the supply chain interruptions and inventory shortages in the US over the past six weeks, the demand for our products and brands continues to grow. Bubs achieved record weekly USA sales in November 2023 of over $770,000. Once we are back in a full stock position, we expect our growth rate will increase further.”
US-based clinical trial
In September in the US, Bubs started a nationwide enrolment for its growth monitoring study (GMS) clinical trial. The first infant was enrolled in late August and the formula manufacturer plants to enrol infants online and through 13 healthcare clinics across the US.
The study is designed to evaluate the growth, tolerance, and safety of new infant formulas as a standard part of the US regulatory process.
The company said that since it began importing into the US as part of Operation Fly Formula in May 2022, it has been building its brand with caregivers and paediatricians and is now the top goat milk formula in the country.
Bubs is now working to transition from the temporary ‘enforcement discretion’ to a permanent market position.
The successful completion of the Protein Efficiency Ratio (PER) study in June 2023, a key US regulatory milestone that validates protein quality, paved the way to proceed with the clinical trial.
In line with the regulatory timeline, Bubs plans to submit results from the GMS to the FDA by September 2024 with a full infant formula submission by October 2024. The ongoing partnership with the FDA and formal processes associated with regulatory approval continue to be an operational and strategic priority for Bubs’ management team.
Bubs’ clinical trial involves a nationwide growth, tolerance, and safety study of healthy term infants consuming Bubs’ infant formulas monitored by healthcare professionals. The study evaluates all three Stage 1 formulas in the market including goat milk, two cow milk products as well as a commercially available formula as the control. Additionally, the study contains a breast-feeding cohort for reference. Infant growth during the study is measured by healthcare professionals at designated clinical sites, with additional input from parents and caregivers.
The study is being conducted by Validcare.
