Consort Medical (LON:CSRT) said the impending launch of a generic Advair inhaler by Mylan (NSDQ:MYL) represents a significant opportunity for its Bespak drug delivery device unit, but analysts were less impressed after the FDA delayed its decision date for asthma therapy to March 28, 2017.
That pushed CSRT shares down -1.9% to a $1.35 (941 pence) close yesterday on the London Stock Exchange, but investors pushed the stock up 4.9% to a $1.41 (987p) close today after Consort said it doubled the top line in fiscal 2016. Sales were up 50% to $396.4 million (£276.9 million) and pretax earnings were $46.2 million (£32.3 million), up 42.5%. The numbers were bolstered by the company’s $329.3 million (£230 million) acquisition of contract manufacturer Aesica in November 2014.
Consort said that manufacturing the inhaler for Mylan’s upcoming generic of GlaxoSmithKline’s Advair (dubbed DEV610) will require the construction of a 5,500-square-meter facility at its existing site in King’s Lynn, England, and is “expected to provide a platform for launch of additional products in the Mylan pipeline.”
Analysts were more focused on the FDA’s decision date for DEV610, which was slightly later than expected. Also delayed was launch of the company’s Voke inhaler (DEV200) to combat nicotine addiction.
“Slightly later launch dates for both DEV200 (launch now expected in next 12 months) and DEV610, revealed today as Mylan’s generic Advair, with full launch likely in calendar Q2 2017, take the shine off the strong performance,” Panmure Gordon analyst Julie Simmonds said, according to a UK financial news service.
Numis Securities said the Vectura Group and Hikma Pharmaceuticals are also launching a generic version of Advair, with an FDA decision date set for May 10, 2017.
Highlights of Consort’s fiscal year include a $4.7 million (£3.3 million) equity investment in Precision Ocular, which gave the company its 1st combined device and drug formulation contract, and the launch of the Syrina 2.25 compact autoinjector.
($1 = £0.69862)