Original-Research: Neovacs S.A. - von GBC AG
Einstufung von GBC AG zu Neovacs S.A.
Unternehmen: Neovacs S.A.
Anlass der Studie: Research Report (Initial Coverage)
Kursziel: EUR 2.90
Letzte Ratingänderung: -
Analyst: Cosmin Filker
* Neovacs S.A., a biotechnology company based in France, focuses on the
develop-ment of what are known as kinoids, which are used for the treatment
of autoimmune and inflammatory diseases. Within the Kinoid platform, which
was developed within the company, interferon alpha kinoid (IFN? kinoid) has
progressed the furthest towards clinical approval for the two indications
SLE (systemic lupus erythematosus) and DM (dermatomyositis). Further
products based on Kinoid technology which could address autoimmune diseases
are currently in preclinical development and represent possible upside
* It is assumed that both autoimmune diseases DM and SLE are caused by the
dysregulation of the cytokine IFN?. Neovacs' technology addresses IFN? with
the aim of neutralising the overproduction of IFN?, thereby bringing the
immune system back into balance. The Neovacs kinoid can be used to trigger
a highly targeted immune response without the addition of foreign
antibodies. High effectiveness and the absence of rejection reactions (with
no loss of efficacy) have both been observed in previous studies. With
regard to Belimumab (trade name Benlysta(R)), which is currently the only
approved drug for the treatment of SLE, doubts have been cast about the
additional benefit of this comparatively expensive active substance.
Life-threatening side effects have also been observed.
* The Neovacs drug is currently being researched in a clinical study IIb
(SLE) in 19 countries (Europe, Asia, Latin America and the USA) with 178
patents. We expect the first results to be available in the summer of 2017.
In parallel, a licensing agree-ment has also been concluded with Chong Kun
Dang (CKD) Pharmaceutical Corp. for the South Korean market. There is a
high chance that SLE will be categorised as a rare disease (orphan disease)
in South Korea, which would enable faster marketing approval and omit the
lengthy periods of time and high costs associated with trial phase III. The
indication DM may achieve global orphan disease status, which is
characterised by a significantly lower prevalence, although we expect
faster global marketing authorisation here. A clinical phase I/IIa trial is
expected to start here in 2016.
* We expect marketing revenues to be generated for the first time in 2018
(SLE - South Korea). While we anticipate that the marketing approval for
the indication DM will be granted in 2020, global marketing for the
indication SLE is likely to start in the 2022 financial year. Initially, we
have conservatively assumed a small market share. Fundamentally, the IFN?
kinoid should generate a lot of attention and, therefore, high potential
demand, particularly considering the lack of medication available for the
incurable diseases SLE and DM.
* Within the scope of the DCF valuation model, we calculated a fair value
of EUR2.90 per share and, on the basis of the current price level of EUR0.86,
have issued a BUY rating. We have taken the existing marketing risk of
phase II products into account with a valuation allowance of 77.2%. During
a meta-analysis, it was noted that 77.2% of drugs in phase II studies do
not achieve market approval. Once clinical progress is recorded, we will
reduce the risk discount corre-spondingly.
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