GILD: Reports 3rd Quarter Earnings

GILD - Gilead Sciences is a top selection for 2014. Today after the close, the company comfortably beat top and bottom line analyst 3rd quarter estimates and guided higher for the remainder of 2013.  Here are some highlights and future potential catalyst.
*  Today's earnings beat on the revenue side of 2.78 versus a 2.72 estimate and earnings per share was .52 cents versus an estimate of .48 cents. GILD also raised year end guidance numbers.
*  Stock buybacks will continue into next year.
*  On Friday October 25th, the FDA advisory panel voted unanimously in favor to approve Sofosbuvir to treat several forms of Hepatitis C.  The total HCV market is 10 billion dollars annually.
*  The final FDA approval could come at anytime from here through December.
*  Analyst are forecasting $1.85 billion in sales alone for Sofosbuvir in 2014, if it prices around $85,000 per patient.  I think that is rather conservative and I expect the company to beat the numbers throughout 2014.
The weekly chart below is near all time highs and appears to be overbought in the short term.  I expected to see some profit taking post report, but we will have to see how that plays our tomorrow.

Bottom Line:  GILD looks ready to have a strong 2014 with the launch of HCV drug Sofosbuvir. The key to the approval expected in December is how the FDA allows for the labeling on approval. Thank you for reading. 

OMER: ($11.41) More Positive Data Points

A PR from Omeros released on Thursday provided even more detail on a previously run FDA phase 1 trial with OMS824 (PDE10) program for Schizophrenia.  The company has been gathering some nice safety, tolerability, pharmakonitec, dosing levels, and PET scan data from just this phase 1 trial.  Below is a rundown of that data.

Phase I  OMS824 trial for Schizophrenia patients:

A)  OMS824 has achieved 63% engagement (PET scans) at a higher dose than previously reported at PDE10 and did not trigger the dose limiting side effects seen with other PDE10 inhibitors.
B)  Healthy male subjects received OMS824 once daily for seven days at a dose higher than previously evaluated in the target-engagement clinical trial.
C)  The drug was well tolerated, with mild somnolence as the only apparent side effect.
D)  In May, Omeros reported that a lower dose evaluated in an ongoing PET clinical trial demonstrated target engagement greater than had been previously reported for any PDE10 inhibitors.  The results showed a 50% occupancy at the selected dose without triggering extrapyramidal symptoms.

The company is currently in a phase II trial with OMS824 for stable Schizophrenia subjects, evaluating safety as the primary outcome, and pharmakonitecs and cognition as secondary outcome. The results will be released by the end of 2013.

Bottom Line:  Effective inhibition of the PDE10 is a promising mechanism for the treatment of Huntington's or Schizophrenia disease.  Omeros has been gathering some nice data on this previously run phase I trial, and is currently in a phase II trial which will gather even more data on the safety, tolerability, and some cognition reports may be possible.  The company has said that the cognition secondary outcome may not be substantial with a small size of just 32 patients.  Thank you for reading.