Update: Aligning timings
Vernalis’s preparations for the potential Q315 launch of Tuzistra XR, its first extended release (ER) cough cold product for the US prescription-only market, are well underway. Tuzistra XR has a 30 April 2015 PDUFA date. In addition to ongoing staged investment into establishing the US commercial infrastructure, the company is changing its accounting reference date and financial year end (from 31 December to 30 June) to be better aligned with the inherent seasonality of the US cough cold market. This update note restates our forecasts and valuation to reflect this.Vernalis is a holding company. Through its subsidiaries, Co. is a commercial stage pharmaceutical company focused on drug development. Co. has three marketed products: Tuzistra® XR, in the U.S. prescription cough cold market; Moxatag®, the only once-daily amoxicillin approved in the U.S. for tonsillitis and pharyngitis; and frovatriptan, an acute treatment for migraine. In addition, Co.'s nine programs in its new chemical entity development pipeline are: V158866 for central nervous system indications; CP1-444 and V2006 for immuno-oncology indications; AUY922, Tosedostat, Bcl-2, Mcl-1, and V158411 for cancer indications; and RPL554 for chronic obstructive pulmonary disease indications.
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