reports
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Thomas Couvreur
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
Sequana Medical CMS proposes NTAP top up payment for the alfapump
Sequana announced that the Centers for Medicare and Medicaid Services (CMS) recommends that alfapump system cases be eligible for incremental payment via a new technology add-on payment (NTAP). This proposal could bring an NTAP top-up payment of up to $ 19,500 on top of the existing DRG payments, boosting the device's reimbursement position, and could make the alfapump procedure profitable for hospitals, which is likely to help drive adoption. With center training due to be completed by the end ...
- Jacob Mekhael
Sequana Medical FIRST LOOK: Additional funding extends runway to YE25
Sequana announced that it has secured additional financing including a €4m convertible, and a facility agreement with GEM up to €20m, as well as amending the terms of the Kreos and PMV loans. The new cash provides funding to YE25, and gives the company breathing room to progress towards US commercialisation of the alfapump expected in 3Q25. We plan to incorporate this new financing in a future model update. BUY reiterated.
- Jacob Mekhael
- Wim Hoste
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
Sequana Medical Becoming a commercial stage medtech
With the alfapump FDA approval in liver ascites obtained in 4Q24, Sequana enters 2025 with the clear aim of building out its commercial organisation in the US. While the company's cash runway is until 1Q25, we believe the FDA approval could attract new investors into the stock, and US commercialisation is targeted for 2H25. We re-model Sequana taking into account the updated timelines, and estimate peak sales of approx. €240m for the alfapump in liver ascites in the US. This brings us to a new T...
- Jacob Mekhael
- Michiel Declercq
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: Publishes 6-month alfapump results in live...
Sequana announced that the previously reported 6-month data from the pivotal POSEIDON study of the alfapump in recurrent or refractory ascites due to liver cirrhosis was published in the American Journal of Gastroenterology. This follows the recent FDA approval obtained for the alfapump in December 2024. Sequana expects US commercial launch to take place in 2H25 subject to additional financing to extend the company's cash runway beyond 1Q25.
- Jacob Mekhael
- Thomas Vranken
Sequana Medical FDA approval for alfapump
Sequana receives a nice Christmas present this year as it obtained PMA approval from the FDA for its alfapump system in the treatment of r/r ascites due to liver cirrhosis, ahead of the guided 1Q25 timeline. We see the approval as an important derisking event for the company, which will enable the company to address a market opportunity of $ >2bn (mgmt. estimates) in the US. The commercialisation intends to specifically target 90 liver transplant centres and is expected to launch in 2H25. We not...
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Kristof Samoy
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Sequana Medical FIRST LOOK: Convertible loan broadened with additional...
Sequana has expanded its existing € 6.1m convertible loan announced on September 30, 2024 with an additional € 1.0m from existing investors. Same terms apply for the additional cash, as it provides a bit more leeway into the expected PMA approval for the alfapump (expected 1Q25).
- Jacob Mekhael
Sequana Medical € 6m convertible and debt restructuring extend runway ...
Sequana reported 1H24 results and announced a new convertible loan of € 3.05m (additional tranche of € 3.05m), extending its runway into 1Q25. The company is exploring separating the DSR and alfapump businesses into Hive-Downs to solve for the lack of synergy between programs. Additionally, Sequana restructured its debt with Kreos, PMV, Belfius, and Sensinnovat. Responses to the FDA 90 Day letter will submitted on 1 October, and alfapump PMA approval continues to be expected by 1Q25.
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Jacob Mekhael
- Michiel Declercq
- Thomas Vranken
Life Sciences Conference 26.09.2024
This conference booklet is your guide to our Life Sciences Conference set to take place on Thursday, 26 September 2024 at our historic building at Grand Place in Brussels. This event offers the possibility to have one-on-one meetings and/or join pitch sessions with the following companies and their top management: Public: AUTOLUS | GALAPAGOS | HYLORIS | INVENTIVA | MAAT PHARMA | ONWARD MEDICAL | SEQUANA MEDICAL | UCB | ZEALAND PHARMA Private: CONFO TX | MRM HEALTH | PANTERA | SKYLINE DX
- Jacob Mekhael
- Thomas Vranken
- Jacob Mekhael
Sequana Medical Presents alfapump QOL benefit in liver ascites at EASL
Sequana will present previously reported outcomes from a matched cohort analysis of the POSEIDON study and NACSELD3 registry showing a quality of life benefit with comparable safety for the alfapump vs. standard of care (paracentesis) in liver ascites, at EASL being held 5-8 June. We believe the data continues to support the alfapump's positioning and look forward to PMA approval expected in 1Q25, and subsequent US commercial launch in 2H25. We reiterate our BUY rating and € 6 TP.
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