Original-Research: MagForce AG - von GBC AG

Einstufung von GBC AG zu MagForce AG

Unternehmen: MagForce AG


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.

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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.-

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