OPKO Health’s Annual Report a Mixed Bag

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OPKO Health’s fourth-quarter report highlighted positive activities in the face of a net loss of $213.9 million during the most recent quarter.

Miami-based Opko Health, Inc.’s fourth-quarter report highlighted positive activities in the face of a net loss of $213.9 million during the fourth quarter, compared to $147.7 million in the same period the year before.

The company’s chairman and chief executive officer, Phillip Frost, said at the company’s conference call to investors, “There were a number of headwinds at BioReference, a slower-than-expected ramp-up in sales of Rayaldee and some unexpected one-time impacts on our financial performance. On the other hand, we’ve made significant progress. We’re in the process of selecting the next president of BioReference from the group of highly qualified candidates that we are hopeful about and we are hopeful that early science of improved results there will continue.”

The company reported total revenues for the quarter of $193.7 million, down from $275.5 million in the same period in 2016. For the full year, it reported $1.07 billion in total revenues, down from $1.22 billion in 2016.

Although its diagnostic business, BioReference Laboratories, the third largest reference laboratory in the U.S., struggled this year, the company is working on system improvements and cost reductions, as well as recruiting new leadership. Steve Rubin, the company’s executive vice president, Administration, said during the call, “We are particularly excited about the potential for BioReference Labs’ GeneDx subsidiary, which continues to demonstrate growth and innovation in its high complexity exome and related tests with a 49 percent year-over-year increase in exome-based testing volumes. These include a new exome-based test, which will open up and further expand other clinical areas for testing such as for patients with neurologic conditions and critically ill patients.”

The company’s sales of Rayaldee, despite the slow start, have been increasing. The drug is indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 kidney disease. OPKA also recently signed a licensing deal for Rayaldee with the Torii Pharmaceutical Division of Japan, Tobacco.

OPKO is also touting its 4Kscore blood test for prostate cancer. The test is given to men with elevated prostate-specific antigen (PSA) levels, and then provides a personalized prediction of the likelihood of an aggressive form of the disease. Rubin said in the conference call, “During the fourth quarter, 20,600 4Kscore tests were performed, a 15 percent increase compared with the fourth quarter of 2016.”

They have also increased their marketing efforts for the test with a series of TV ads in the New York region and in Florida. Rubin added, “New payment schedules implemented on January 1, 2018 provided a 26 percent increase in 4Kscore reimbursement. Medicare reimbursement is now $760 per test, up from approximately $600 per test previously. In addition, we’ve expanded our clinical validity studies in subjects who are diagnosed with borderline Gleason 6 prostate cancer. For example, the soon-to-be-published Homburg radical prostatectomy study has demonstrated that the 4Kscore tests can effectively differentiate biopsy Gleason 6 cancer from those men likely to harbor adverse pathology.”

The company also filed a pre-market approval application with the U.S. Food and Drug Administration (FDA) for its Claros 1 immunoassay analyzer in total PSA test. This assay can provide rapid, quantitative blood test results in 10 minute in the physician’s office on a finger stick drop of blood comparable to the PSA test.

OPKO also has a number of programs in the clinic, including continuing trials to expand Rayaldee worldwide, such as OPK88002, which will begin a Phase IIA trial for uremic pruritus or itching in dialysis patients, hGH-CTP in a Phase III for growth hormone deficiency in children, and OPK88004, an oral selective androgen receptor modulator (SARM) for patients with benign prostate hypertrophy (BPH) or enlarged prostate.