Original-Research: MagForce AG - von GBC AG
Einstufung von GBC AG zu MagForce AG
Unternehmen: MagForce AG
Anlass der Studie: Research Report (Anno)
Kursziel: 9.15 EUR
Kursziel auf Sicht von: 31.12.2023
Analyst: Cosmin Filker, Marcel Goldmann
- Stage 2b of the trial for approval in the USA is currently ongoing - Billing code by the American Medical Association is available - Break-even expected from 2024
In the past financial year 2021, MagForce AG continued or resumed the planned European roll-out for the treatment of malignant brain tumours (glioblastoma). The four NanoActivator devices currently installed in Germany and Poland are to be supplemented by a further site in Spain. In September 2021, an agreement was signed in this regard with the Spanish clinic Complejo Hospitalario Integral Privado (CHIP). Once all approvals have been obtained, the first commercial treatments are to take place in Spain from the second half of the current financial year 2022.
In the past financial year 2021, the treatment of glioblastoma in the four active treatment centres was also affected by the pandemic-related closure measures. The resulting decline in patient enquiries led to a decrease in sales revenue to EUR 0.35 million (previous year: EUR 0.62 million). Due to the unchanged low level of revenues, the earnings picture remains negative. EBIT amounted to EUR -6.74 million (previous year's adjusted EBIT: EUR -6.93 million).
Another relevant step towards market approval was achieved in the indication area of prostate cancer. After the successful completion of the penultimate stage 2a of the pivotal study had been announced at the beginning of 2021, the final study protocol was submitted by the FDA in December 2021. This enabled the company to start the final stage of the pivotal US trial-stage 2b. In stage 2b, which is now underway, the results of the previous stage are to be confirmed in up to 100 patients. The trial is currently being conducted at MagForce's own centres in San Antonio, Seattle and Sarasota. Another important step for approval in the USA is the approval of the American Medical Association (AMA) billing code obtained in April 2022. This will provide the basis for Medicare to cover the costs of the clinical trial and for price negotiations with payers after successful approval.
Reimbursement approval for study patients has been granted and CPT codes for commercial patients are also in place. This means that MagForce will be reimbursed already whilst treating patients in the study. This guarantees the smooth reimbursement transition from the study to commercial treatments.
MagForce expects FDA filing for approval in the USA at the turn of 2022/2023. As the current study is being conducted at MagForce's own centres, a seamless transition to commercialisation can be assumed. For the current financial year 2022, however, we are assuming very low treatment revenues for prostate cancer treatment, which are related to the cost coverage of the clinical trial by Medicare. Only in the coming financial years should the very high revenue potential of this indication area become visible. In the indication area of glioblastoma, we assume a further expansion of the treatment centres and a corresponding increase in the number of treatments in the coming financial years. This should also take place against the background of the expected abolition of the corona restrictions.
Within the framework of our forecast model, MagForce AG should be able to break even at all earnings levels from the 2024 financial year onwards. On this basis, we have a target price of EUR9.15 within the framework of our DCF valuation model and we continue to assign a BUY rating.
Die vollständige Analyse können Sie hier downloaden: http://www.more-ir.de/d/24589.pdf
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Date and time of completion of the study: 12.07.2022 (4:16 pm) Date and time of the first disclosure of the study: 13.07.2022 (10:00 am)
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