Isis Pharma (ISIS) Reports In-Line Q2 EPS

Isis Pharma (NASDAQ: ISIS) reported Q2 EPS of $0.29, in-line with the analyst estimate of $0.29. Revenue for the quarter came in at $120.4 million versus the consensus estimate of $114.93 million.

Drug Development Highlights (2015 second quarter and subsequent activities)

• Isis reported positive clinical results from KYNAMRO, ISIS-SMNRx and ISIS-TTRRx. These data exemplify the broad applicability and potential for antisense drugs to provide therapeutic benefit for many different diseases.
  • Isis reported that the FOCUS FH study evaluating KYNAMRO in patients with severe heterozygous familial hypercholesterolemia met its primary endpoint with a statistically significant reduction of LDL-Cholesterol. Genzyme and Isis plan to report the full data from this study at an upcoming medical meeting.
  • Isis presented positive results based on an April 17, 2015 data analysis from the ongoing open-label Phase 2 clinical study of ISIS-SMNRx in infants with Type I spinal muscular atrophy. The data reported showed continued increases in median event-free survival and muscle function scores as well as achievement of developmental milestones.
  • Isis provided an update based on a May 15, 2015 data analysis in children with spinal muscular atrophy who have completed the open-label, Phase 2 multiple-dose study of ISIS-SMNRx and are continuing to receive treatment in an open-label extension study. Consistent with earlier observations, increases in muscle function scores and additional motor function tests were observed in children treated with ISIS-SMNRx.
  • Dr. Merrill Benson, an investigator of ISIS-TTRRx, reported positive data from an investigator-initiated study in patients with TTR amyloid-related cardiomyopathy. In this study, Dr. Benson observed apparent stabilization of cardiac disease after six months of treatment with ISIS-TTRRx with no progression of cardiac disease. Patients also experienced up to 88 percent reduction in TTR after nine months of dosing compared to baseline.
  • Isis reported positive results from an ongoing open-label extension study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (FAP). In the open-label study after thirteen weeks of treatment with ISIS-TTRRx, TTR protein was reduced up to 92 percent with a median reduction of 78 percent in patients with FAP compared to their baseline TTR levels at entry into the Phase 3 study.
  • Isis reported positive Phase 2 data for ISIS-GCCRRx in patients with type 2 diabetes. In this study after six weeks of treatment with ISIS-GCCRRx, patients achieved improvements in multiple measures of glucose control with trends toward improvements in insulin sensitivity.
• Isis published clinical data from its novel lipid drugs, volanesorsen and ISIS-APO(a)Rx, in the New England Journal of Medicine and The Lancet, respectively, two prestigious medical journals. These data highlight the significant interest from the medical community in Isis' lipid drugs and the significance of the clinical data from these programs.
• Volanesorsen was granted orphan drug designation from the US FDA for the treatment of patients with familial chylomicronemia syndrome.
• Isis continued to advance its pipeline of drugs.
  • Isis initiated a Phase 1/2 study of ISIS-HTTRx in patients with Huntington's disease (HD). ISIS-HTTRx has been granted orphan drug designation by the European Medicines Agency for the treatment of patients with HD.
  • Isis initiated a Phase 2 study to evaluate the safety and activity of ISIS-FGFR4Rx in patients who are obese.

For earnings history and earnings-related data on Isis Pharma (ISIS) click here.

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