The company, best known for Exondys 51 (eteplirsen) for Duchenne muscular dystrophy (DMD), reported a net loss of $276.4 million for the quarter compared to a loss of $109.3 million in the same period in 2018. For the six-month period ending June 30, Sarepta reported a net loss of $353 million.
Cambridge, Massachusetts-based Sarepta Therapeutics released its second-quarter finances, reporting a quarterly loss of $3.74 per share compared to the Zacks Consensus Estimate of a loss of $1.08.
The company, best known for Exondys 51 (eteplirsen) for Duchenne muscular dystrophy (DMD), reported a net loss of $276.4 million for the quarter compared to a loss of $109.3 million in the same period in 2018. For the six-month period ending June 30, Sarepta reported a net loss of $353 million.
For the quarter, the company recorded net revenues of $94.7 million, up from $73.5 million in the second quarter of 2018. The big hit is research-and-development expenses, where the company reported $113.3 million for the second quarter.
“As we pass through mid-2019, we are very pleased to announce strong performance and solid execution against our goals,” stated Doug Ingram, Sarepta’s president and chief executive officer. “Exondys 51 (eteplirsen) continues to perform with second quarter sales of $94.7 million, 29% growth quarter over same quarter last year.”
Most of the news emphasized the company’s progress in R&D, with an interesting note that in addition to working on gene therapies for Rett Syndrome, cardiomyopathy, Emery-Dreifuss muscular dystrophy type 1, the company was moving outside of rare disease to work on multiple sclerosis.
In the second quarter, Sarepta dosed its first patient in its Phase II MOMENTUM trial of SRP-5051 for DMD patients amenable to exon 51 skipping. They also dosed 24 patients in Study 102, a trial of its micro-dystrophin gene therapy for DMD. The company also received conditional approval of the brand name Vyvondys 53 for its golodirsen for DMD in patients with genetic mutations amenable to skipping exon 53 of the dystrophin gene.
“In our RNA franchise, we advanced our Vyondys 53 (golodirsen) application, with an FDA PDUFA date of August 19, are preparing to submit for casimersen, with a target PDUFA date in the first half of 2020, and have commenced dosing our PPMO SRP-5051 MAD trial,” Ingram stated. “ With respect to our gene therapy platform, we have completed the dosing of the 24 patients in our placebo-controlled micro-dystrophin trial as forecasted, made significant progress in the built out of our commercial micro-dystrophin process and manufacturing facility, advanced our gene therapy engine, and through internal development and partnering have added a number of new programs to our pipeline.”
R&D expenses were actually lower for the second quarter of 2019, $113.3 million, compared to $122.8 million for the same period in 2018. This was caused by a $44.9 million decrease in upfront and milestone payments related to license agreements offset by an upfront payment of $60 million to Myonexus as part of a stock agreement; a drop of $2.7 million in collaboration cost sharing with Summit as it wraps up its Utrophin platform; and another decrease of $2.2 million in preclinical expenses because of the completion of specific toxicology studies in its PPMO platform.
It increased clinical and manufacturing expenses of $16.5 million as it ramped up its micro-dystrophin program, its ESSENCE program and launched post-market studies for Exondys 51. The company also increased compensation and other personnel expenses by $9.9 million because of an increase in headcount, and another $7.4 million related to expanding its manufacturing and technology capabilities.
