reports
- Thomas Vranken
Fagron FIRST LOOK: Deep-dive into Fagron's warning letter
Following a conference call with management and a readthrough of the warning letter regarding Fagron's Wichita site, our assessment confirms that the issues highlighted in the letter refer mainly to observations that were already known to and being addressed by Fagron since last summer. While the language used by the FDA in the letter is strong, we interpret this in a broader context of the regulator raising the bar on quality standards in the pharmaceutical compounding industry. Three topics we...
- 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...
- ING Helpdesk
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
Fagron updates on FDA communication regarding the June 2024 inspection...
Fagron updates on FDA communication regarding the June 2024 inspection at Wichita Regulated information – inside informationNazareth (Belgium)/Rotterdam (The Netherlands), 23 Dec 2024 – 7AM CET Fagron updates on FDA communication regarding the June 2024 inspection at Wichita Following the FDA’s routine inspection at Fagron’s Wichita facility conducted in June 2024, the Company received a warning letter from the FDA (Warning Letter) on December 19, 2024. The Warning Letter requires Fagron to enhance processes for investigating discrepancies, and validations of future manufacturing ca...
Fagron verschaft een update over de FDA-communicatie met betrekking to...
Fagron verschaft een update over de FDA-communicatie met betrekking tot de inspectie in Wichita in juni 2024 Gereglementeerde informatie – voorwetenschap Nazareth (België)/Rotterdam (Nederland), 23 december 2024 – 7:00 CET Fagron verschaft een update over de FDA-communicatie met betrekking tot de inspectie in Wichita in juni 2024 Na de routine-inspectie van de FDA van de vestiging in Wichita in juni 2024, ontving de Vennootschap op 19 december 2024 een waarschuwingsbrief van de FDA (Warning Letter). De waarschuwingsbrief verplicht Fagron om de processen voor het onderzoeken van afwi...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
Dynamic Top Pick List How to start 2025?
On this Friday the 13th we select for you 13 stocks to start 2025 with a bang : ABN Amro, Ackermans & van Haaren, Bekaert, D'Ieteren, EVS, Fagron, Fugro, Gimv, Melexis, Shurgard, Sofina, WDP and Xior However, we maintain a defensive stance in our Benelux selection at the start of 2025.. The long anticipated interest rate cuts by central banks are expected to continue their decline into 2025 (see graph above). However, the Trump election victory in the US hits European stocks even before he tak...
- 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
Disclosure of notification received from FMR LLC
Disclosure of notification received from FMR LLC Regulated information Nazareth (Belgium)/Rotterdam (The Netherlands), 26 November 2024 – 6.45 PM CET Disclosure of notification received from FMR LLC Pursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received a notification from FMR LLC. Notification by FMR LLC On 21 November 2024, Fagron received a notification that the shareholding of Fidelity Management & Research Company LLC, a controlled undertaking of FMR LLC, crossed the disclosure threshold of 3% upwards on 18 Nov...
Openbaarmaking van kennisgeving ontvangen van FMR LLC
Openbaarmaking van kennisgeving ontvangen van FMR LLC Gereglementeerde informatie Nazareth (België)/Rotterdam (Nederland), 26 november 2024 – 18u45 CET Openbaarmaking van kennisgeving ontvangen van FMR LLC Fagron heeft een kennisgeving ontvangen op grond van de Belgische Wet van 2 mei 2007 op de openbaarmaking van belangrijke deelnemingen in beursgenoteerde vennootschappen van FMR LLC. Kennisgeving van FMR LLC Op 21 november 2024 heeft Fagron een kennisgeving ontvangen dat het aandeelhouderschap van Fidelity Management & Research Company LLC, een onderneming onder controle van FMR LLC,...
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
Dynamic Top Pick List Update November 2024 – Adding Azelis – Removing ...
With 2 changes in our Dynamic Top Pick list (we add Azelis and we remove Solvay) we maintain a defensive stance on the market for 2H24. The long anticipated interest rate cuts by central banks have finally started. The Trump election victory in the US does not bode well for European stocks as he favours a protectionist course. Although industrial companies with a US base could actually benefit. Cleantech names with exposure to the US could also suffer (unless owned by E.Musk). We expect the US ...
BEKB BEKAERT SA
ABN ABN AMRO BANK NV DEPOSITARY RECEIPTS
FAGR FAGRON SA
EVS EVS BROADCAST EQUIPMENT SA
XIOR XIOR STUDENT HOUSING N.V.
SOLB SOLVAY SA
COFB COFINIMMO SA
DIE D'IETEREN SA
SOF SOFINA SA
IBAB ION BEAM APPLICATIONS SA
ACKB ACKERMANS & VAN HAAREN NV
KIN KINEPOLIS GROUP NV
NN NN GROUP N.V.
TINC TINC COMM. VA
FUR FUGRO NV
AZE AZELIS GROUP NV
SYENS SYENSQO
- 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).
- Thomas Vranken
Fagron Model update: FY24 outlook
Following Fagron's 3Q24 update, we update our FY24 outlook to reach the upper end of the revenue guidance of € 850-870m. In the coming quarters and years, we expect sustained solid performance across business units, as the company continues to benefit from increased outsourcing of pharmaceutical compounding and its operational excellence initiatives. We reiterate our € 24 TP, reflecting 27% upside vs the current share price, hence reiterate our Buy rating.
- Thomas Vranken
- Luis de Toledo Heras
ODDO BHF Small & MIDCAP MORNING NEWS - 10/10/2024
Burckhardt Compression is a leading global supplier of compression solutions with a unique product offering (full range of reciprocating compressor technologies and services). It targets profitable growth with a 2022-2027e sales CAGR of 7.7% and a 2022-2027e EBIT CAGR of 12.1%. These prospects seem adequately discounted at our TP of CHF 612 reflecting historical and peer multiples. We initiate the coverage with a Neutral rating. - ...
- Luis de Toledo Heras
ODDO BHF Small & MIDCAP MORNING NEWS - 10/10/2024
Burckhardt Compression is a leading global supplier of compression solutions with a unique product offering (full range of reciprocating compressor technologies and services). It targets profitable growth with a 2022-2027e sales CAGR of 7.7% and a 2022-2027e EBIT CAGR of 12.1%. These prospects seem adequately discounted at our TP of CHF 612 reflecting historical and peer multiples. We initiate the coverage with a Neutral rating. - ...
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