Medincell's Moment: UZEDY's Rise Fuels a New Pharma Licensing Model

MONTPELLIER, France – December 01, 2025

Next week, on December 9th, investors and industry analysts will tune in for Medincell’s half-year financial results. While such calls are routine, this one carries particular weight. It represents a critical data point for a company transitioning from a clinical-stage innovator to a commercial-stage licensing powerhouse. The central question is no longer about the potential of its proprietary BEPO® drug delivery technology, but about the velocity of its commercial execution and the financial currents it generates. With its first major product, UZEDY®, gaining significant market traction, Medincell stands at an inflection point, offering a compelling case study in how platform technology can reshape patient care and create substantial investor value.

The UZEDY® Catalyst: From Approval to Revenue Engine

The story of Medincell’s recent transformation is inextricably linked to UZEDY®, a long-acting injectable (LAI) for schizophrenia and, as of October 2025, Bipolar I Disorder. Commercialized by pharma giant Teva Pharmaceuticals, the drug’s performance has been nothing short of remarkable. After its initial FDA approval for schizophrenia in April 2023, Teva’s early sales forecasts proved conservative. The company's initial projection of $80 million in 2024 sales was shattered, with the drug ultimately bringing in $117 million for the year.

This outperformance translates directly to Medincell's top line. As the licensor of the underlying BEPO® technology (branded SteadyTeq™ by Teva), Medincell receives mid- to high-single digit royalties on all net sales. The impact is stark: royalties invoiced to Teva surged from €1.7 million in fiscal year 2024 to €6.5 million in fiscal year 2025—a nearly fourfold increase. This royalty stream is the first major validation of the company's business model, proving its ability to generate recurring revenue from its intellectual property.

The recent FDA approval for Bipolar I Disorder significantly expands UZEDY®'s addressable market, a development that will be closely watched in upcoming quarters. Furthermore, approvals for schizophrenia in Canada and South Korea in 2025 signal the beginning of a global rollout. The commercial landscape was also favorably altered when the manufacturer of Perseris®, a competing risperidone LAI, announced its withdrawal from the market in July 2024, removing a direct competitor and potentially streamlining UZEDY®'s market penetration.

BEPO® Technology: The Science Behind the Strategy

While UZEDY®'s numbers are impressive, the engine driving this success is Medincell’s BEPO® technology. The platform forms a small, fully bioresorbable depot under the skin after a simple subcutaneous injection, enabling the controlled release of a drug for weeks or even months. This elegantly solves one of modern medicine’s most persistent challenges: patient adherence to treatment regimens for chronic diseases.

Nowhere is the strategic value of this technology more apparent than in Medincell’s pipeline. The next major candidate poised for market entry is mdc-TJK, a long-acting formulation of olanzapine, another widely used antipsychotic. Developed with Teva, the drug recently completed a successful Phase 3 trial. Crucially, the trial reported no instances of Post-Injection Delirium/Sedation Syndrome (PDSS), a serious and sometimes debilitating side effect associated with the current market-leading olanzapine LAI, which requires a mandatory three-hour post-injection observation period in a registered healthcare facility.

If mdc-TJK secures FDA approval without this black-box warning—with a New Drug Application submission expected in the second half of 2025—it could achieve first-in-class status and fundamentally disrupt the olanzapine LAI market. For Medincell, this would not only trigger a €4.8 million milestone payment already received from Teva but also open up a second major royalty stream, further accelerating its path toward profitability.

Building a Pipeline Through Strategic Capital

Medincell is aggressively leveraging its technological validation to build a diversified and capital-efficient pipeline. The company’s strategy hinges on high-value partnerships that de-risk development and provide non-dilutive funding. The landmark agreement signed with AbbVie in April 2024 exemplifies this approach. The deal, which covers up to six therapeutic programs, came with a $35 million upfront payment and holds the potential for up to $1.9 billion in milestone payments, plus tiered royalties.

This partnership structure allows Medincell to focus on its core competency—formulation and early-stage development—while partnering with industry leaders for costly late-stage trials and commercialization. Beyond its blockbuster pharma collaborations, the company is also applying its technology to global health challenges through partnerships with the Bill & Melinda Gates Foundation for a long-acting contraceptive and Unitaid for an anti-malaria treatment. This diversified portfolio, spanning high-margin commercial products and high-impact global health initiatives, mitigates risk and creates multiple avenues for future growth.

The Financial Horizon: Navigating Towards Profitability

The strategic execution is clearly reflected in Medincell's improving financial health. The company's total income grew by an impressive 132% in fiscal year 2025 to €27.7 million. More importantly, operating losses were nearly halved, and the net loss improved by 26% to €(18.4) million. The infusion of capital from the AbbVie deal and a strengthening cash flow from UZEDY® royalties have fortified its balance sheet, with cash and low-risk financial investments standing at a robust €71.9 million as of March 31, 2025.

This strong cash position provides a crucial runway to advance its pipeline, including the next clinical development stages for a post-operative pain candidate (mdc-CWM) and programs in contraception and malaria expected to enter the clinic in 2025. Management has set an ambitious but increasingly plausible goal: achieving operational profitability by the fiscal year ending March 31, 2027.

As stakeholders prepare for the December 9th webcast, they will be looking for confirmation that the powerful revenue momentum from UZEDY® continued through the first half of the current fiscal year. The results will serve as a key barometer for the company's trajectory, offering insight into the pace of UZEDY®'s market adoption and providing the first financial report since the pivotal Bipolar I approval. For investors tracking the intersection of innovation and industry, Medincell's story is a current that is rapidly gaining force.