Opko Health Reports 2016 Financial And Operating Results

• U.S. commercial launch of RAYALDEE underway
• 4Kscore test utilization continues to grow; Level 1 CPT code and CMS pricing in place
• Pediatric global phase 3 initiated and Japanese registration trial for hGH-CTP commencing shortly
• Adult study trial data analysis near completion; preparation for Biologics License Application (BLA) submission underway
• Clinical trials of Claros point of care (POC) PSA test began in January 2017; PMA filing anticipated upon completion; Claros POC testosterone test clinical trials and 510(k) filing to follow
• Initiation of four Phase 2 trials anticipated in 2H 2017 and early 2018
   - RAYALDEE for dialysis patients with secondary hyperparathyroidism (SHPT)
   - OPK88003, an orally administered selective androgen receptor modulator (SARM) for BPH (Benign Prostatic Hypertrophy)
   - OPK88004, a once weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity
   - OPK88002, an NK-1 inhibitor to treat pruritus (itching) in dialysis patients
• OPK8801, Orphan Drug Status received in the U.S. and EU for new Oligonucleotide to treat Dravet Syndrome; IND planned for 2H 2017
• Clinical trials ongoing for long acting Factor VII-CTP
• Consolidated revenue for the quarter ended March 31, 2017 increased to $296.1 million from $291.0 million for the comparable 2016 period
• For the three months ended March 31, 2017, net loss was $31.0 million compared to net loss of $12.0 million for the comparable 2016 period
• Financial results reflect significant investments in our pipeline development and marketing and sales expenses related to the introduction of RAYALDEE

 MIAMI, May 09, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), reports operating and financial results for the three months ended March 31, 2017.

Business Highlights

• U.S. commercial launch of RAYALDEE underway:  RAYALDEE was launched by our experienced commercial marketing and sales teams and substantial progress has been made in obtaining formulary access for RAYALDEE, with more than 60% of potential patient lives now covered under insurance plans.  Obtaining broad insurance coverage is a critical step in the adoption of the use of RAYALDEE. 
• Forthcoming revisions to the Kidney Disease Improving Global Outcomes (or KDIGO) Clinical Practice Guidelines for Chronic Kidney Disease – Mineral and Bone Disorder CKD-MBD) are expected to recommend against the routine use of vitamin D receptor activators (VDRAs) for the treatment of SHPT in this population.  This guideline is also expected to highlight the unproven effectiveness of nutritional vitamin D as a treatment for SHPT and is anticipated to greatly enhance the adoption of RAYALDEE therapy by physicians and patients.
• Dr. Akhtar Ashfaq, a board certified nephrologist with significant industry experience, has joined OPKO as Senior Vice President, Clinical Research & Development and Medical Affairs.  Dr. Ashfaq will support commercial and scientific development strategies for RAYALDEE.
• 4Kscore test utilization continues to grow; Level 1 CPT code and CMS pricing in place, negotiations with payors continue.  Level 1 CPT code and CMS pricing became effective on January 1, 2017, and the Company is actively working to secure coverage with additional payors.  During the quarter ended March 31, 2017 approximately 18,600 4Kscore tests were ordered which represents growth of more than 100% from the first three months of 2016. 
• Phase 3 pediatric trial for hGH-CTP initiated; Analyses of data from long acting hGH-CTP trial in adults continue and BLA preparation for FDA submission underway:  OPKO will complete a statistical outlier analysis of data from its Phase 3 trial study in adults and, together with Pfizer, is preparing a BLA for FDA submission.