Met dank aan:
jurpsy @ 04-08-2015 21:27:32 (http://www.ErikErik.com / Pharming)
Treating hereditary angioedema, one rabbit at a time
Driven by its lead product Ruconest, we believe Dutch biotech company Pharming Group N.V. is finally poised for growth. Launched in the US in November 2014, Ruconest, a recombinant human protein for the acute
treatment of the rare genetic disorder hereditary angioedema (HAE) has had a successful launch to date. We expect growing sales of the drug to deliver profitability from 2017, and believe the sales potential of the drug is under-appreciated. We therefore initiate coverage of Pharming with a Buy recommendation and set a 12-month target price of €0.88.
Targeting near-term profitability. Pharming looks set to be transformed
through the commercialisation of its key product Ruconest, sales of which have accelerated since US launch in November 2014. The company is now funded through to profitability, with growing Ruconest sales likely to deliver this from 2017. Expansion of the drug's approval to include prophylaxis and paediatric use should boost growth from 2018E. Longer-term growth may come from other potential uses for Ruconest, in indications such as Acute Pancreatitis and Ischaemic Reperfusion Injury (IRI). Pharming is also in the process of reinvigorating its pipeline of potential novel transgenic therapies.
We forecast sales of Ruconest of $335m by 2020. Having received FDA
approval in July 2014, Ruconest was launched in the US by marketing partner Valeant in November 2014 and has had a successful launch to date, with revenues of c.$11m. Pharming has various ways to achieve further upside from Ruconest; regaining further EU territories from marketing partner SOBI to leverage its growing EU infrastructure and optimise margins; expanding indications to include prophylaxis and paediatric use; and future potential in other inflammatory diseases such as Acute Pancreatitis and Ischaemic Reperfusion Injury (IRI). For now, we believe Ruconest is well on track to meet our forecasts of $37m in sales for 2015 and forecast $335m of sales by 2020E
(assuming approval in prophylaxis in 2018).
Innovative technology platform to provide future pipeline. In August 2014
Pharming acquired five potential new product leads from French company
Transgenic Rabbit Models, from which Pharming plans to build a pipeline of new biological drugs. Through a collaboration with the Shanghai Institute of Pharmaceutical Industry (SIPI), Pharming is developing the first of these, a recombinant human Factor VIII protein as a replacement therapy for the hereditary disorder Haemophilia A. Pharming is planning to enter preclinical trials at the end of 2016 and will look to address a portion of the $4bn global Haemophilia A market.
Initiating coverage with a Buy recommendation and €0.88 target price.
Driven by a very encouraging launch in the US, we believe Ruconest has the potential to take Pharming to profitability in 2017 and beyond. On an NPV basis we value Pharming at €0.88 a share, representing significant upside from its current price of €0.33, based primarily on the potential of Ruconest as
a treatment for HAE……………………………………..