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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:
http://www.more-ir.de/d/23079.pdf
Kontakt für Rückfragen
GBC AG
Halderstraße 27
86150 Augsburg
0821 / 241133 0
research@gbc-ag.de
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Offenlegung möglicher Interessenskonflikte nach § 85 WpHG und Art. 20 MAR. Beim oben analysierten Unternehmen ist folgender möglicher Interessenkonflikt gegeben: (5a,11); Einen Katalog möglicher Interessenkonflikte finden Sie unter:
http://www.gbc-ag.de/de/Offenlegung
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Date (time) of completion: 15/11/2021 (08:30 am)
Date (Time) first distribution: 15/11/2021 (10:00 am)
-------------------übermittelt durch die EQS Group AG.-------------------
Für den Inhalt der Mitteilung bzw. Research ist alleine der Herausgeber bzw.
Ersteller der Studie verantwortlich. Diese Meldung ist keine Anlageberatung
oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.
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Quelle: dpa-AFX