OPKO Health Reports Third Quarter Financial And Operating Results

  • Consolidated revenue increased to $298.0 million for the three months ended September 30, 2016 from $143.0 million for the comparable period of 2015.  Consolidated revenue for the nine months ended September 30, 2016 increased to $946.2 million from $215.5 million for the comparable period of 2015.
  • Net loss was $15.0 million for the three months ended September 30, 2016 compared to net income of $128.2 million for the comparable period of 2015.  For the nine months ended September 30, 2016, net loss was $11.4 million compared to net loss of $31.6 million for the comparable period of 2015
  • U.S. commercial launch of RAYALDEE® planned for late November 2016; full marketing and sales team now in place
  • Completed acquisition of Transition Therapeutics; Phase 2 clinical trial protocols for two important products being developed
  • 4Kscore test utilization continues to grow; many payors now in place, negotiations with others continue
  • Topline data for three long acting biologic products to be presented
    • Long acting hGH-CTP topline Phase 3 data in adults in 4Q 2016
    • Long acting Factor VIIa-CTP safety data from the first in human Phase 2a trial in early 2017
    • Long acting oxyntomodulin first in human Phase 1 safety data expected early 2017
  • Clinical trials for Claros point of care (POC) PSA test to begin in late 2016; PMA filing anticipated in 1H 2017; Claros POC testosterone test clinical trials and 510(k) filing to follow in 2017

MIAMI, Nov. 07, 2016 (GLOBE NEWSWIRE) --  OPKO Health, Inc. (NASDAQ:OPK), reports financial and operating results for the three months ended September 30, 2016.

Financial Highlights
  • Consolidated revenues for the three months ended September 30, 2016 increased to $298.0 million from $143.0 million for the comparable period 2015. The 2016 period includes revenue from BioReference, acquired in August 2015. 
  • Net loss for the three months ended September 30, 2016 was $15.0 million compared with net income of $128.2 million for the 2015 period.  Net (loss) income during the three month periods include significant non-recurring and non-cash activities:
    • The 2015 period includes a non-recurring income tax benefit related to the release of a valuation allowance against our deferred tax assets as a result of the BioReference acquisition; and
    • Other income and (expense) was ($10.5) million and $47.0 million in the 2016 and 2015 periods, respectively, primarily related to the change in fair value of derivative instruments. The change in fair value is principally related to an embedded derivative in OPKO's January 2013 convertible senior notes due in 2033. The 2015 period also includes a non-recurring gain of $17.3 million related to our deconsolidation of SciVac Therapeutics Ltd.  The three months ended September 30, 2016 includes $3.9 million of other than temporary impairment expense for two of our strategic investments as a result of a decrease in share price.
  • Cash, cash equivalents and marketable securities were $144.6 million as of September 30, 2016.  

Business Highlights
  • RAYALDEE launch scheduled for late November 2016:  The U.S. Food and Drug Administration (FDA) approved RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).  OPKO has now completed hiring and training a highly specialized marketing and sales team, which is ready for the November 2016 launch .
  • Transition Therapeutics:  The acquisition of Transition Therapeutics Inc., a Toronto-based biotechnology company, closed in August 2016. Transition Therapeutics has two drugs in mid-stage clinical development; TT401, a long acting GLP-1/glucagon dual agonist for the treatment of type 2 diabetes and obesity, and TT701, an orally administered selective androgen receptor modulator (SARM) being developed for the treatment of patients who will benefit from its effects on increasing muscle and bone strength and decreasing body fat mass.
  • 4Kscore test utilization continues to grow; reimbursement in place with many payors, coverage negotiations continue with others:  Reimbursement of the 4Kscore test is progressing; pricing agreements are already in place with several payors, and the Company is working to obtain positive coverage by its local Medicare administrator.  During the quarter ended September 30, 2016, approximately 16,000 4Kscore tests were performed, a 9% increase from the quarter ended June 30, 2016 and a 365% increase over the comparable period of 2015.
  • Topline data for three long acting biologic programs anticipated
    • Long acting hGH-CTP topline Phase 3 data in adults in 4Q 2016: OPKO expects to report topline results from its Phase 3 trial evaluating the safety and efficacy of once weekly injections of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with growth hormone deficiency (GHD) in the fourth quarter of 2016. The trial is a randomized, double-blind, placebo controlled, multicenter, global study in adults with GHD.
    • Long acting Factor VIIa-CTP safety data from the first in human Phase 2a trial expected in early 2017:  This is a dose escalation study to determine safety for OPKO's long-acting version of coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.
    • Long acting oxyntomodulin first in human Phase 1 safety data expected early 2017:  OPKO's Phase 1 single dose escalation study to evaluate the safety and pharmacokinetics of our long acting oxyntomodulin (MOD-6031) in healthy subjects was successful in determining the maximum tolerable dose, indicating activity, as expected.
  • Clinical trials for Claros point of care (POC) PSA test to begin in late 2016; PMA filing anticipated in 1H 2017; Claros POC testosterone test clinical trials and 510(k) filing to follow in 2017: OPKO intends to commence a multi-center clinical study of OPKO's POC diagnostic test for prostate specific antigen (PSA) utilizing its proprietary diagnostic platform in late 2016. OPKO intends to submit its application to the FDA for approval of the assay in mid-2017.  OPKO expects to commence an additional multi-center clinical study for its POC testosterone test in 2017 followed by a 510(k) submission in late 2017.

"We are finalizing the details of our commercial launch of RAYALDEE and have completed the selection and hiring of a very talented commercial team, all of whom bring deep relationships in the nephrology and specialty pharmaceutical sales market," stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.  " RAYALDEE will be an important medicine for a large number of chronic kidney disease patients suffering from SHPT and vitamin D insufficiency.  We are working closely with the Vifor Fresenius Medical Care Renal Pharma team to bring RAYALDEE  to market outside the U.S. and are presently planning the start of a Phase 3 trial in dialysis patients which  represents the first potential line extension for RAYALDEE in addition to its currently approved indication. 

"With the Transition Therapeutics acquisition, we now have two additional important drugs in Phase 2 development; one for patients who could benefit from its effects on increasing bone and muscle strength while decreasing fat mass; the other for type 2 diabetes and obesity.  Each drug has already been studied and shown to be safe in approximately 400 patients.  We are also very pleased to now have the benefit of an experienced Transition Therapeutics team led by its CEO, Tony Cruz.

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