— R&D expense jumped by 92% largely due to spending on fulvestrant and payroll expenses. SG&A expense increased by 45% due to external legal spend associated with litigation on pemetrexed and vasopressin, as well as payroll costs.
— Looking ahead into 2020, the company expects adjusted R&D spend to be $46-50 million and adjusted SG&A spend to be $61-64 million.
— During mid-February, the company received final approval from the FDA for its novel product, Pemfexy, a branded alternative to Alimta. This represents a significant opportunity to expand its presence in the oncology space.
— The company resubmitted a new drug application for Ryanodex for the treatment of exertional heatstroke, in conjunction with body cooling, to FDA. Eagle anticipates approval by its PDUFA date of July 8, 2020, with the potential to be commercially available for the upcoming heat season.
— Eagle is currently working on the design of a second study for Ryanodex for the treatment of brain damage secondary to nerve agents exposure. The company expects to commence the study this year, with the intention to file an NDA for this indication before the year-end 2020.