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In September 2024, IntraBio achieved FDA approval for its first commercial product – a revolutionary treatment for Niemann-Pick disease type C (NPC), a rare, fatal genetic disorder affecting the central nervous system and other organs.
With regulatory approval secured, IntraBio set its sights on creating additional value for shareholders through accelerated commercialization. But a successful launch for its approved drug would require strengthening the company’s operational and financial capabilities. To support its evolution from a pure drug discovery organization to a fully commercial enterprise, the company needed to deepen its expertise in cash flow management, international transactions, and systems integration — all critical components for successful commercialization.
IntraBio’s manual processes were sufficient during its R&D phase, when payables were limited and operations were lean. But with rapid growth ahead — including greater organizational complexity, a rising headcount, and international expansion — relying on time-consuming manual systems would be error-prone, time-consuming and distracting for its executives who needed to focus on achieving the company’s strategic goals.
Faced with the need to elevate its systems to a much higher standard while minimizing internal resource demands, IntraBio decided against building new internal teams — a path that would have required significant cost and carried considerable risk. Instead, the company sought an external partner for financial and operational management. “With regulatory approval comes a host of additional challenges: cash flow forecasting, international tax compliance, and IT systems that IntraBio had never previously needed,” explains Mallory Factor, CEO and Chairman of IntraBio. “We needed a first-rate team to manage these critical functions, so we chose EY, the market leader, rather than building an internal team ourselves. This allowed us to focus on overseeing EY’s implementation and management of these systems, rather than having to hire an internal team to build them ourselves.”