Q3 2018 expense guidance
In the third quarter, OPKO Health (OPK) expects research and development expenses of $33 million–$38 million, and foresees its total operating expenses falling to $285 million–$305 million. The company has projected a single-digit effective tax rate for Q3 2018. In fiscal 2018, analysts expect OPKO Health’s adjusted diluted EPS to rise ~51.0% to -$0.24, while peers Novartis (NVS), Merck (MRK), and Regeneron (REGN) are expected to report adjusted diluted EPS of approximately $5.20, $2.60, and $20.40, respectively.
4Kscore test adoption trends
In Q2 2018, 20,500 4Kscore tests were used in the market, representing a 10% YoY (year-over-year) rise. 4Kscore tests help predict the probability of aggressive prostate cancer in patients based on their prostate-specific antigen levels. OPKO Health reported that 80% of the urologists who ordered this test in Q1 2018 reordered it in Q2 2018, highlighting its strong retention rate.
Rayaldee growth trends
OPKO Health’s first and only FDA-approved drug, Rayaldee, which reduces parathyroid hormone levels and increases 25-hydroxy vitamin D levels in CKD (chronic kidney disease) patients, saw revenue of ~$4.8 million in Q2 2018. According to IMS Health, Rayaldee prescriptions rose 467% YoY and 36% sequentially in the second quarter.
On July 16, OPKO partner Vifor Fresenius Medical Care Renal Pharma secured Health Canada’s approval to commercialize Rayaldee as a treatment option for SHPT (secondary hyperparathyroidism) in Stage 3 or 4 CKD patients with vitamin D insufficiency. OPKO Health plans to initiate a Phase 2 trial to study Rayaldee as a treatment option for SHPT in Stage 5 CKD patients with vitamin D insufficiency requiring hemodialysis.