Original-Research: MagForce AG (von GBC AG): BUY

Original-Research: MagForce AG - von GBC AG

Einstufung von GBC AG zu MagForce AG

Unternehmen: MagForce AG

ISIN: DE000A0HGQF5

Anlass der Studie: Research Comment

Empfehlung: BUY

Kursziel: 13.20 EURO

Kursziel auf Sicht von: End FY 2015

Letzte Ratingänderung:

Analyst: Cosmin Filker, Felix Gode

Important milestone reached in the approval process in the USA;

Investigational Device Exemption submitted as planned; market approval for

the treatment of prostate cancer in the USA expected from mid-2017

According to company reports dated 21/05/2015, MagForce AG announced that

it had submitted an Investigational Device Exemption (IDE) to the US

American regulatory authority FDA. This completes the next significant step

for the approval of NanoTherm(R) therapy for the treatment of prostate

cancer patients in the USA.

The planned single-arm study is designed to proof the ablation of prostate

cancer lesions (cancer-related tissue damage) is to be provided in up to

120 patients, whereby patient selection is based on the internationally

recognized Gleason Score (values between 2 and 10), used to classify the

extent and growth of the prostate tumor.

With the submission of the IDE to the FDA, MagForce AG entered the approval

process according to plan. According to the FDA, the review process of

application documents as well as the study approval for the medical device

will take up to 180 days. In parallel, MagForce AG will take the necessary

preparatory actions for the clinical trial phase. We can therefore assume

that start of the registration study of NanoTherm(R) therapy will probably

follow directly upon FDA approval of the IDE submission, i.e. shortly

before the end of 2015. A period of approximately twelve months must be

considered for the actual clinical trial with the primary endpoint of

'ablation of prostate cancer lesions'. Within this period, the patients

will be treated at the study centres. We assume that, following a six-month

period, additional biopsies could be taken to confirm the final study

endpoint, so that the application for market approval could be submitted at

the end of the upcoming financial year 2016.

As part of our research study (Initial Coverage) dated 19/05/2015, we have,

as an important basis of our forecasts, assumed that marketing in the

indication prostate cancer will commence from mid-2017. In this respect,

the most recent corporate news confirms our prior assumptions and the

filing of IDE submission to the FDA as planned has resulted in the

reduction of the timing risk.

Based on our unchanged forecasts, we expect an EBIT break-even in the 2017

financial year and therefore confirm the fair value per-share of EUR13.20

determined in the DCF model and a 'BUY' rating.

Die vollständige Analyse können Sie hier downloaden:

http://www.more-ir.de/d/12959.pdf

Kontakt für Rückfragen

Jörg Grunwald

Vorstand

GBC AG

Halderstraße 27

86150 Augsburg

0821 / 241133 0

research@gbc-ag.de

-------------------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.