Sosei Group Corporation (4565, Tokyo Stock Exchange, Mothers Market) today reported financial results for the financial year ended 31 March 2012.
Net sales for the fiscal year ended March 2012 totalled ¥862M (¥716M in the same period a year ago). Income in this period consisted mainly of milestone revenue from Novartis triggered by NVA237 filing for marketing authorisation with the European Medicines Agency (EMA), milestone revenue from ASKA triggered by launch of NorLevo® (emergency contraceptive), and sales of NorLevo® in Japan and Australia.
Selling, General and Administration (SG&A) expenses totalled ¥2,571M (¥2,542M in the same period previous year) as a result of the company’s continued efforts to suppress overall cost-increase. Within SG&A, R&D expenses were ¥227M (¥288M in the previous year). Other SG&A costs were ¥755M (¥665M in the previous year), an increase of ¥89M that is a result of NorLevo® related manufacturing and commercialization costs. Amortisation of goodwill, relating to the acquisition of Sosei R&D amounted to ¥1,588M which is equivalent to the previous year.
Ordinary loss was ¥1,950M (¥1,962M in the prior year), while net loss was ¥1,954M, a decrease of ¥82M (¥1,871M in the previous year) due to a decrease in extraordinary income.
As of 31 March 2012 the Group had ¥1,497M cash and cash equivalent balance and no outstanding debt, compared to ¥1,751M as of 31 March 2011.
Product development progress during the financial year ended 31 March 2012:
NorLevo® 0.75mg TABLETS
NorLevo® was launched in Japan as a first emergency contraceptive in May 2011, and is now being distributed through ASKA Pharmaceutical distribution network.
NVA237 and QVA149 for chronic obstructive pulmonary disease (COPD)
NVA237 is a dry powder formulation for inhalation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) with a rapid onset of activity. NVA237 was licensed to Novartis in April 2005 by Sosei and our co-development partner, Vectura Group.
At present, NVA237 is under regulatory review in the EU, where it was submitted for approval in September 2011 under the brand name Seebri® Breezhaler®, triggering a $5M milestone payment to Sosei. Novartis expects to receive CHMP opinion on NVA237 approval in mid-2012. In Japan, Novartis submitted NVA237 for approval in November 2011, and signed a co-promotion agreement with Eisai Co. Ltd in the same month. In the US, Novartis have agreed the Phase III trial design for NVA237 with FDA and expect to file the product for approval at the beginning of 2014.
Phase III data presented at ERS (European Respiratory Society) in September 2011 demonstrated improvements compared to placebo, while additional Phase III data are expected to be presented at a major medical congress in H1 2012.
QVA149, a fixed-dose combination of NVA237 and indacaterol maleate (Onbrez® Breezhaler®) remains on track for submission in ex-US countries starting in the fourth quarter of 2012. In April 2012 Novartis announced topline data from the first four Phase III studies, SHINE, BRIGHT, ENLIGHTEN and ILLUMINATE, which are key components of the IGNITE program. The results from these studies, demonstrate the potential of QVA149 in the treatment of COPD.