The group’s business model focuses on the commercialisation of Zeneo, a needle-free injection device capable of delivering various therapeutic entities. Manufacturing costs are low, at approximately €10 per unit, compared to the market value of the final product, which includes the device and its contents. Consequently, significant potential exists once Zeneo enters the market with the launch expected in FY25, along with substantial returns. Until then, financing remains a critical issue, potentially sourced from financial markets, bank debt, licensing and government incentives in France and the US. Looking ahead, Crossject is aiming to position itself as a provider of these devices, akin to an industrial company, by creating value through the mass production of Zeneo with high quality and reliability standards. Our business forecasts for the group are based on the following:
Conservative assumptions
Our assumptions are grounded in the launches of the current NTEs under development by the group. For the remaining specialities, clinical studies are planned for FY25-27, with regulatory approvals and commercial launches expected in FY26, such as for Midazolam (“Zepizure”). We assume products will be sold through partnership agreements, allowing Crossject to benefit from upfront fees and royalties, which will partially finance clinical studies. We estimate Crossject’s turnover at 40% of the final user’s purchasing price, with the remainder covering distributor/wholesaler margins for logistics and marketing. We also apply a risk factor, ranging from 10% to 50% depending on the product, which is reasonable given the lighter and faster registration process compared to new compounds. For NTEs, the timeline is closer to three years, depending on the product and geography, and should not exceed five years. The efficacy of molecules is already proven, and NTE applications require only bioequivalence studies, reducing costs (€3-4m versus €200m for a new chemical entity) and time to market. The filing process (FDA and EMA) will focus on product reliability and bioequivalence results.
Our forecasts are not overly aggressive
Our estimates are based on the group’s assumptions for the number of units sold (Zeneo devices) and their growth from commercial launch to maturity for each sub-market (each NTE), with a probability reflecting the risk of approval issues and challenges in finding suitable partners. Although it is difficult to predict Crossject’s market share in each sub-market, the group is targeting reasonable shares (10-20%, except for Hydrocortisone, where it is aiming for 30% of this small market). To remain conservative, we assume these targets will not be achieved before 2030, i.e. approximately 3 to 5 years post-launch, depending on the NTE.
For example, we assume Adrenaline will launch in 2027, with a 60% probability, and Crossject will sell 2 million doses annually by 2029 at an in-market price of €40 in Europe and US$100 in the US. This results in a theoretical €160m turnover by 2029 at end-user prices, or €112m considering the 70% probability assigned to this NTE. However, from an accounting perspective, Crossject will receive only a 45% share, with the full turnover recorded on its partner’s books.
Finally, the company will be significantly dependent on the US$, as volumes will be substantial in the US and prices are considerably higher, sometimes 5-6 times those in the EU. This will impact both translation (US$/€ parity) and transaction (costs primarily in €).
