Medincell
French biotech based near Montpellier, specialised in long-acting injectable formulations through its BEPO® platform. FY 2025-26 marks the acceleration of the transition toward a stable royalty model: UZEDY® (Teva, schizophrenia) generated $215M in net sales (+52.5% YoY), and olanzapine LAI (TEV-‘749) was approved by the FDA on 9 October 2026 as WELTRUZA™, the second approved product built on Medincell technology, with a US launch by Teva expected in the following weeks.
Investment thesis
- 01
Patented BEPO® platform, validated by two FDA approvals (UZEDY® in 2023, WELTRUZA™ / olanzapine LAI in October 2026) — a durable and repeatable competitive moat.
- 02
Asset-light model: commercialisation outsourced to industrial partners (Teva, AbbVie); Medincell captures the upside through royalties and milestone payments without sales force commitment.
- 03
UZEDY® (risperidone LAI, schizophrenia) accelerating commercially: $215M of Teva net sales in FY 2025-26 vs $141M in the prior year (+52.5%); associated Medincell royalties of €9.3M now structurally anchor the P&L.
- 04
Olanzapine LAI (TEV-‘749, built on Medincell's proprietary SteadyTeq™ technology) approved by the FDA on 9 October 2026 as WELTRUZA™: the first and only once-monthly subcutaneous olanzapine injectable for adults with schizophrenia, with no loading dose or oral supplementation at initiation and no post-injection monitoring required. US availability from Teva announced for the following weeks; EMA MAA accepted on 21 May 2026, review ongoing. Medincell earns mid-to-high single-digit royalties on worldwide net sales and remains eligible for up to $112M in milestone payments, including $4M on US approval and up to $105M tied to sales thresholds.
- 05
AbbVie partnership: the first co-developed programme is progressing toward the initiation of clinical development, broadening the portfolio beyond psychiatry.
- 06
Long-acting ivermectin programme: a non-exclusive license has been granted to the Medicines Patent Pool for low- and middle-income countries — a differentiated public-health angle.
- 07
Balance sheet reinforced in March 2026 by a €48.2M raise from US and European healthcare investors; total liquidity €84.8M (including €62.8M cash) at year-end. In July 2026, a non-dilutive refinancing — €28M of new European bank loans, with no covenant or equity-linked instruments — extended debt maturity by more than 3 years to mid-2031 and funded the early repayment of a €20M tranche of the EIB loan. On 13 October 2026, an additional €13.8M of non-dilutive financing was secured from European commercial banks and Bpifrance, on market terms and with no equity-linked instruments, bringing the total secured since July 2026 to €41.8M; debt maturity extended through September 2031: a financial structure aligned with the ramp-up of combined UZEDY® + olanzapine LAI royalties.
Catalysts
US launch of WELTRUZA™ (olanzapine LAI, TEV-‘749) by Teva
FDA approval obtained on 9 October 2026 under the WELTRUZA™ brand; Teva plans US availability in the following weeks. Approval triggers the $4M milestone and opens the mid-to-high single-digit royalty flow on worldwide net sales; up to $105M of commercial milestones remain tied to sales thresholds. The pace of uptake will be the next indicator to watch. Ahead of approval, the timeline had been reiterated in September 2026 at Psych Congress (15–19 Sept., New Orleans), where Teva presented new post hoc analyses of the Phase 3 SOLARIS trial: of 411 participants in the long-term treatment period, 56% achieved stabilisation, 4% of stabilised participants subsequently relapsed, and 21% of the 183 participants treated for at least six months met remission criteria.
EMA review of olanzapine LAI (MAA accepted 21 May 2026)
With the MAA accepted, the second key market is open; the next expected milestone is the European decision, triggering the $3M milestone and additional royalties on EU sales.
UZEDY® royalty trajectory
Confirmed ramp-up: UZEDY® net sales of $85M in Q3 2026 (+96% YoY), following $77M in Q2 (+43% YoY), for $225M over the first nine months of 2026, above the $191M of full-year 2025; Teva raised its 2026 guidance for the third time, to $290–310M (from $270–290M in Q2 and $250–280M in Q1). Medincell earns mid-to-high single-digit royalties and remains eligible for up to $105M in commercial milestone payments. At Psych Congress 2026, new real-world data highlighted better treatment continuity on UZEDY® versus other long-acting injectable antipsychotics, and lower healthcare resource utilisation versus once-monthly paliperidone palmitate.
First AbbVie programme entering clinical development
Expected start of the first clinical trial co-developed with AbbVie — first visible milestone of the partnership beyond the deal signing.
New partnerships / platform extensions
Medincell's ability to sign new reformulation deals: a key signal of the industry's perceived value for BEPO® after the dual UZEDY® + olanzapine LAI validation.
Combined general meeting: voting results
Combined general meeting held on 30 September 2026 in Jacou: 885 shareholders present, represented or voting by mail, for a turnout of 66.21% (ordinary part) and 65.84% (extraordinary part). 33 of the 34 resolutions put to the vote were adopted, including the appointment of Dr Elisabeth Svanberg as a director (6th, 93.95%), the capital-increase delegations (16th to 22nd, between 71.70% and 90.63%) and the amendment to the articles allowing the appointment of a director representing employee shareholders (32nd, 99.82%). Remuneration resolutions passed with narrower majorities: amounts paid or awarded for FY 2025-26 to CEO Christophe Douat (8th, 54.26%) and to Chairman Philippe Guy (9th, 58.51%), remuneration policy for the Chairman (11th, 55.37%) and the CEO (12th, 65.86%). The authorisation to grant share subscription and/or purchase options (27th) was rejected, with 57.59% of votes in favour, below the two-thirds majority required at an extraordinary meeting; the share warrant (28th, 68.29%) and free share (29th, 67.29%) delegations were adopted.
Risks
Short-term revenue concentration
At this stage, recurring revenue rests almost entirely on UZEDY® through Teva. The arrival of WELTRUZA™ royalties (olanzapine LAI, FDA-approved on 9 October 2026) will reduce single-product dependence from late 2026, but both products are marketed by the same partner and diversification remains to be confirmed.
Dependence on partner commercial choices
Medincell does not directly control pricing, reimbursement or sales force decisions. The royalty trajectory depends on Teva execution (UZEDY®, soon olanzapine LAI), then AbbVie on the first clinical programme.
WELTRUZA™ commercial execution and EMA decision
US regulatory risk has been lifted by the 9 October 2026 FDA approval. What remains is the commercial uptake of WELTRUZA™ in an already competitive long-acting injectable antipsychotic market, and the European decision on the MAA accepted by the EMA in May 2026, whose outcome and timing are not guaranteed.
Income statement still loss-making
Operating loss of €(20.8)M on the closing year for €24.3M of revenue and €45M of Opex (+17% YoY). The path to profitability depends on the dual UZEDY® + olanzapine LAI engine; the March 2026 raise (€48.2M) secures the horizon but further dilution remains possible if the trajectory slips.
Valuation multiple volatility
The market oscillates between a pharma-services / royalties reading and a biotech / pipeline reading, with significant multiple gaps. The ongoing narrative transition may amplify share-price moves.
Calendar
- 21 mai 2026Olanzapine LAI MAA accepted by EMA — review ongoingClinical
- 9 oct. 2026FDA approval of WELTRUZA™ (olanzapine LAI) · US launch by Teva expected in the following weeksClinical
- 15–19 sept. 2026Psych Congress 2026 (New Orleans) · new Teva data on olanzapine LAI (SOLARIS post hoc analyses) and UZEDY® (real-world)Clinical
- 14–25 sept. 2026Investor conference tour · Morgan Stanley 24th Annual Global Healthcare and H.C. Wainwright 28th Annual Global Investment (14–16 Sept.), Jefferies Healthcare C-Suite Back-to-School Fireside Chat (22 Sept.), BioCentury Annual Grand Rounds Europe in Amsterdam (23–25 Sept.)Conference
- 30 sept. 2026Combined general meeting · Jacou; 33 of 34 resolutions adopted (turnout 66.21%), share option authorisation (27th) rejectedAGM
- 9 déc. 2026H1 FY 2026-27 results (April–September 2026) · date moved from 8 to 9 Dec. for operational reasonsEarnings
- 2026-2027Partner pipeline milestones (AbbVie, Teva)Clinical
Governance
Stable historical leadership around the co-founders, now complemented by a dedicated medical function: Edna Venneker, MD, was appointed Chief Medical Officer on 1 September 2026, having previously been Head of Development and Senior Vice President at Grünenthal, where she also served as Deputy Chief Medical Officer. Board renewal underway since 2025: Dr Elisabeth Svanberg was appointed as an independent director by the 30 September 2026 AGM (6th resolution, adopted with 93.95%, four-year term, replacing Virginie Lleu whose term was expiring; expected to chair the Remuneration & Nomination Committee), bringing the share of the board renewed since 2025 to 50%. At the same AGM, remuneration resolutions drew narrower majorities (54.26% for the amounts awarded to the CEO for FY 2025-26, 58.51% for the Chairman) and the stock-option authorisation was rejected (57.59% in favour, below the two-thirds threshold), a shareholder signal on remuneration and incentive policy. Capital open to an international institutional shareholder base reinforced in March 2026 by a €48.2M capital increase from US and European healthcare investors. Solid retail shareholder community, especially active at AGMs. CapCordia documents resolutions, votes and management communications, with particular attention to the execution of the transition to the royalty model.
This file is editorial and does not constitute investment advice. Individual shareholders are responsible for their own decisions.