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Managing the complex financial flows and subsidies of clinical trials

Background

A BIOTECH IN CLINICAL TRIAL PHASE BURNS A LOT OF CASH AND CANNOT AFFORD THE ABSENCE OF A BUSINESS CONTROLLER.

A biotech specialized in cell therapies found itself without a business controller.

Meanwhile, clinical studies are ongoing, and the firm employs around fifty people and is burning cash, as is typical for biotechs at this stage of their development. Therefore, it cannot afford to have no one to monitor expenses and establish forecasts while searching for the ideal person for the position.

Investors must be reassured about the proper progress of clinical studies and their commercial promises.

Sometimes trade-offs are inevitable between clinical studies or different departments: along the way, new costs may emerge, studies may turn out to be too expensive or not promising enough, or are too far ahead or behind schedule... Therefore, each study requires financial monitoring, necessitating the examination of flows within each concerned department (lab, clean room, quality control, etc.).

Approach

Altesia assigns its finance consultant, Julien Revel, with a short-term mission to assist the CFO in her tasks and ensure the transition while waiting for a new management controller. He is present three days a week.

"It's important to understand how the company operates, its objectives, identify needs, talk with department heads, know who does what..."

Julien Revel, Finance Consultant at Altesia

The subsidies granted by the Walloon Region, among others, require special monitoring and a lot of reporting. "These are financial movements that are sometimes difficult to follow, and the accounting treatment of these aids can prove complicated," says Julien Revel. Indeed, the company must advance the money to fund its activities and then make a declaration to the Region, which must then accept the request. Between the expenditure and reimbursement by the subsidizing Region, up to eight months can elapse.

For each department, the discrepancies between the forecasts and the actual expenses must be understood and analyzed: why is a particular study progressing faster or slower than expected, and what is the impact on cash flow?

Julien Revel also works on modeling based on different assumptions to understand the impact on cash flows. For example, what happens if a certain budget is eliminated to allocate it to another department for a different clinical study? Or: this product developed for a rare disease could have potential to fight other more common diseases: what would be the implications of new clinical studies to explore this new indication?

"What if we reallocate budgets to another study? What are the financial implications of starting new clinical studies for new indications? I have studied many different scenarios, based on many assumptions proposed by management."

Julien Revel, Finance Consultant at Altesia

Results

Julien Revel stayed eight months within the biotech. The 2022 budget had already been established, so the Altesia expert established the forecast for the end of the year with a revision of forecasts for each department. Then, he set up the 2023 budget with the CFO, taking into account the various advanced assumptions and the needs of the company.

Finally, a month-by-month tracking of expenses by department was established to help management make the right decisions: whether to continue or stop a particular study, slow it down, or speed it up.

 

Regarding the Walloon Region, new subsidy requests were introduced with the different department heads and the clinical director.

And when a new management controller was hired, Julien Revel ensured the handover for about fifteen days.

"Clinical trials involve significant financial movements. Meticulous reporting and forecasting are imperative for the optimal allocation of company funds, ensuring adequate reporting to funding bodies, and maintaining accurate visibility."

Julien Revel, Finance Consultant at Altesia

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