Sanderus bedankt
Bron : kbc securities
BUSINESS DESCRIPTION FINANCIALS AND RECENT NEWS FLOW Ablynx currently has eight nanobodies in clinical development and the first potential product launch is expected in 2018. Caplacizumab – a wholly-owned anti- vWF nanobody to treat acquired Thrombotic Thrombocytopenic Purpura (aTTP) – was filed for approval in Europe in February ‘17 based on strong phase II data and is currently in a pivotal phase III study (HERCULES) to support the US FDA dossier (filing in 2018). Ablynx intends to commercialize the product itself in the US, Europe and Canada. The company is currently in a phase IIb trial RESPIRE for its anti-RSV Nanobody ALX-0171 of which topline results are expected in 2H18. This Nanobody is administered via inhalation, directly to the site of infection, i.e. the respiratory tracts. As for Ablynx’ other late stage asset, vobarilizumab (previously partnered with AbbVie), things are a bit more complex. In 2016, the company released quite positive monotherapy and combination therapy results but the latter were clouded by a high ACR20 placebo rate that caused the study to miss its primary endpoint (likely due to the study design). AbbVie subsequently decided to not go ahead with the compound despite strong objective secondary endpoints and a positive safety profile. AbbVie retains the rights in RA however since the compound is still being studied for a second indication, systemic lupus erythematous, that is expected to show results in 2018. This makes finding a new partner for RA more complex at this stage. Phase III preparations will go through nevertheless and Ablynx will conduct the end-of-phase IIb meetings mid-2017. A phase III trial will be prepared in the meantime, with a launch expected in 2018. A key strength of Ablynx is its excellent cash position. It has raised cash multiple times in the past, based on strong results and sometimes when it wasn’t actually needed. The YE16 cash position was € 235.4m, enabling the company to at least continue its operations until 2020, excluding potential caplacizumab revenue and thus based on the current cash burn guidance of € 75m to € 85m. Year to date, the company has initiated the phase IIb anti- RSV trial, filed caplacizumab at the EMA for conditional approval and released positive results of a psoriasis phase Ib study with M1095, partnered with Merck. While the results are positive, we note that the compound itself started development several years ago and we are unsure at what speed Merck will continue the development. Since it is not a core product for Merck, we expect the company to look for a partner to pursue the development. In terms of news flow, 2H17 has several potential stock triggering events. The HERCULES phase III study of caplacizumab will show results most likely in 3Q17 which are important for filing for US approval (early 2018) and for obtaining full EMA approval. In 1H18, we expect the launch in Europe and in 2019 for the US. We also expect news in terms of the planned commercialisation structure. Ablynx will also launch 2 multi-specific Nanobodies in the clinic in immune-oncology with partner Merck & Co. The current partnership holds 17 fully-funded programs that are targeting multiple immune-checkpoint modulators. Last but not least, a partnering update for vobarilizumab is expected at the 1H17 results in August which could put the asset back in the spotlight.