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Original-Research: MagForce AG (von GBC AG)

Original-Research: MagForce AG - von GBC AG Einstufung von GBC AG zu MagForce AG Unternehmen: MagForce AG ISIN: DE000A0HGQF5 Anlass der Studie: Research Note Empfehlung: Buy Kursziel: 11.00 EUR Kursziel auf Sicht von: 31.12.2022 Letzte Ratingänderung: Analyst: Cosmin Filker, Marcel Goldmann 1st HY 2021: FDA approval for final pivotal study received, forecasts and price target confirmed, rating: BUY In the context of the research study (Anno) of 20.07.2021, we had already postulated our expectations that MagForce AG would probably report low treatment figures overall in Europe (indication area: glioblastoma) in the first half of 2021. This is due in particular to the pandemic-related closure measures, which led to low patient enquiries in both the first and second quarters. In our previous research study, we had only expected an increase in commercial treatments and thus in revenues for the second half of 2021. Consequently, sales revenues of EUR 0.19 million (previous year: EUR 0.38 million) were still below the previous year's value. Due to the unchanged low level of sales, there is still no cost coverage, so that negative values are reported both at the EBIT level and at the level of the after-tax result. In mid-October 2021, MagForce AG received the conditions for approval of the final clinical protocol for the Phase 2b trial from the FDA. After the company submitted the required documents to the regulatory authority, the FDA approved the final study protocol and the start of Stage 2b on 5 November 2021. This means that this Stage 2b, in which up to 100 patients are enrolled, can begin promptly. According to the company's applications, targeted biopsies can be used as desired to assess efficacy. The trial will demonstrate that the Mag-Force technology can be used to treat prostate patients in a targeted manner with minimal side effects. The first results are to be delivered to the FDA after 15 and after 30 treated patients in order to provide an early first indication of the study objective, while patient treatments continue. In the current company announcement, the summer of 2022 was confirmed as the expected approval date. This confirms our previous assumption (see Comment of 18.10.2021), according to which we expected commercialisation to start in the second half of 2022. A rapid start of commercial treatments is possible primarily because the treatment centres and personnel required for commercialisation are already in place for the conduct of the pivotal trial. Accordingly, there is no need to build up the infrastructure. However, it is likely that further centres will be added to the current MagForce treatment centres in Texas, Washington and Florida as early as the 2022 financial year, thus enabling broader regional coverage. Our assumptions for glioblastoma treatment in Europe have also been confirmed with the publication of the half-year report and the cooperation now in place in Spain. We expect that the current portfolio of four NanoActivator devices, in addition to Spain, will be expanded in Italy, Austria and Germany, so that eight treatment centres will be in operation in 2022. In addition, reimbursement will remain a focus. In Spain, for example, an Investigator-Initiated Trial (IIT) is to be carried out at the Carlos Haya Malaga University Hospital, on the basis of which reimbursement is to take place. The treatments in Poland are also to form the basis for reimbursement within the framework of an IIT. With the expansion of the treatment offer, a noticeable increase in commercial treatments is to be achieved in Europe. Parallel to this, with the expected approval in the USA, commercialisation activities for prostate treatment are also to begin from 2022. While the current financial year 2021 should still be characterised by low sales revenues, the company should achieve a visible jump in sales from the coming financial year 2022. As early as the coming 2022 financial year, MagForce AG should be in a position to break even for the first time and at all earnings levels. As we consequently maintain our previous revenue and earnings estimates unchanged, we confirm our previous price target of EUR 11.00 per share. We continue to assign a BUY rating. Die vollständige Analyse können Sie hier downloaden: Kontakt für Rückfragen GBC AG Halderstraße 27 86150 Augsburg 0821 / 241133 0 ++++++++++++++++ Offenlegung möglicher Interessenskonflikte nach § 85 WpHG und Art. 20 MAR. 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Last Updated: 17-Nov-2021