reports
- Jacob Mekhael
Hyloris FY25 results hold no major surprises
Hyloris reported FY25 results with a cash position of € 13.8m (YE24: € 23.6m), and revenue of € 7.2m (FY24: € 8.5m), driven by increased royalties but offset by lower milestone payments. Hyloris is yet to receive income related to commercialisation of Maxigesic IV in the US as the launch has been paused and restarted. The company did not provide specific cash runway guidance, but believes it has funding for development and strategic growth. € 6 TP and Hold maintained.
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Mathijs Geerts Danau
- Thomas Couvreur
- Wim Hoste
- Guy Sips
- Hilde Van Boxstael
- Kristof Samoy
- Mathijs Geerts Danau
- Michiel Declercq
- Thibault Leneeuw
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Mathijs Geerts Danau
Hyloris Valacyclovir oral suspension is delayed
Hyloris provided an update regarding the review of valacyclovir for oral suspension which had a PDUFA target action date of 12 October 2025. It appears that the FDA identified significant inspection observations at the third party manufacturing plant in Greece. The manufacturer confirmed that it is actively implementing its remediation plans. Currently, Hyloris believes that resolution of the manufacturing situation is required to obtain an FDA product approval and is working on a solution. We r...
- Jacob Mekhael
- Kristof Samoy
- Livio Luyten
- Wim Lewi
- Hilde Van Boxstael
- Mathijs Geerts Danau
- Wim Lewi
- Hilde Van Boxstael
- Mathijs Geerts Danau
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Livio Luyten
- Mathijs Geerts Danau
- Michiel Declercq
- Thibault Leneeuw
- Wim Lewi
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Wim Hoste
- Mathijs Geerts Danau
Hyloris Positive results for IV Aspirin, NDA will be submitted
Hyloris announced positive topline results from a pivotal study in healthy volunteers for IV aspirin. The trial achieved all its targets, enabling progression towards submission of a New Drug Application (NDA) in 2026 and expected approval in 2027. IV Aspirin is intended to be used in acute coronary syndrome and is part of Hyloris's CV portfolio, for which Hyloris needs to announce a commercial partner in the US. We model € 52m peak sales by 2037. We reiterate our HOLD and € 6 TP.
- Hilde Van Boxstael
- Lynn Hautekeete
- Mathijs Geerts Danau
- Wim Lewi
- Jacob Mekhael
Hyloris Signs agreement with Orion for Tranexamic Acid RTU in Europe
Hyloris announced that it has entered into an exclusive license and supply agreement with Orion for Tranexamic Acid Intravenous Premix RTU (TXA RTU) in major European markets. This follows a previously announced agreement with Avenacy in the US, though we note this product, being a generic, is non-core for the company, as Hyloris' main focus is on reformulation and repurposing via the 505(b)(2) pathway. The company has not disclosed specific figures under the agreement, however it will be eligib...
- Jacob Mekhael
- Michiel Declercq
- Thomas Couvreur
- Jacob Mekhael
Hyloris HY-094 license and distribution agreement in China
Hyloris announced that an exclusive license and distribution agreement has been signed with Grand Life Sciences Group for HY-094 in iron deficiency in China. While specific financial numbers were not disclosed, Hyloris and partner AFT will share the eligible upfront, milestones, and royalties. We view this China deal as a good start, but note that the country represents a small fraction (approx. $ 150m by 2033) of the global iron IV market, expected to reach $ 7.4b by 2033, and look forward to a...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Mathijs Geerts Danau
- Michiel Declercq
- Thomas Couvreur
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Mathijs Geerts Danau
- Michiel Declercq
- Thibault Leneeuw
- Wim Hoste
- Jacob Mekhael
- Mathijs Geerts Danau
Life Sciences Conference 25 Sep 2025
KBC Securities will host its annual life sciences conference on 25 September in Brussels. The event will include 14 exciting companies, both public and private, from the BeNeLux ecosystem and beyond. In this conference note, we provide an overview of the attending companies, as well as an outlook on KBC Securities' life sciences broader coverage.
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
Hyloris XTRAZA license and supply agreement with Huons in South Korea
Hyloris announced that an exclusive license and supply agreement has been signed with Huons for XTRAZA in South Korea. Under the terms, Hyloris will exclusively supply XTRAZA to Huons though further financial terms were not disclosed. This deal follows previously announced agreements in selected APAC regions and Canada with AFT, and in the UK with Colonis Pharma. A phase 3 trial for XTRAZA is ongoing in the US and EU, with data expected by YE25, and we note that a deal for XTRAZA in the larger U...
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Michiel Declercq
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.