ADMA Biologics Inc. (NASDAQ: ADMA) has announced that it has received approval from the US FDA for VanRX SA25, its in-house aseptic fill-finish machine.
FDA approves ADMA’s VanRx
CEO Adam Grossman said, “The FDA approval of the VanRx marks the successful completion of ADMA’s multi-year supply chain enhancement initiative, firmly establishing ADMA as the only American domiciled end-to-end producer of specialty plasma-derived biologic drugs. Today’s announcement is expected to have transformative financial and strategic implications for ADMA as the company now joins an elite group of U.S.-based drug manufacturers with comprehensive in-house control of its critical manufacturing functions.”
Following VanRx’s approval, the company now has internal fill-finish processes capable of meeting all its commercial product’s expected production needs. As a result, the company expects significantly higher gross margins, greater patient supply dependability, quicker inventory production cycle times, and enhanced visibility and control of commercial product lot announcements once the VanRx is operating, resulting in more predictable near-term revenue outcomes.
Approval a chance to inboard fill-finish capabilities
Grossman concluded, “The approval of the VanRx will also provide ADMA with the opportunity to onboard new fill-finish contract manufacturing opportunities with third parties. This additional revenue stream can provide the company with the ability to potentially exceed previous financial targets, which we will update as progress unfolds. With extensive vertical integration successfully established and the company’s more meaningful capital investment initiatives having now concluded, ADMA is entering the next phase of its profit-focused growth strategy. We look forward to sustaining quarter-over-quarter revenue growth for the foreseeable future as well as meaningfully improving profitability metrics in the periods ahead.”
The FDA-approved increased BIVIGAM® manufacturing production scale at the beginning of the year, combined with the improved vertical integration from the VanRx machine’s approval, will allow the company to quickly bring its products to market, boost margins, and significantly enhance end-to-end control over manufacturing processes.