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Dec 31, 2019
OPKO Health Q4 2019 Earnings Report
OPKO Health's Q4 2019 financial results were reported, with revenue increase and ongoing clinical trials.
Key Takeaways
OPKO Health reported an increase in consolidated revenues for Q4 2019 to $224.3 million compared to $221.9 million in Q4 2018. The net loss for the quarter was $112.4 million, or $0.18 per share, compared to a net loss of $76.1 million, or $0.13 per share, for the comparable period of 2018. The company's cash, cash equivalents, and marketable securities totaled $85.5 million as of December 31, 2019.
Phase 3 trial for Somatrogon met its primary endpoint.
Total prescriptions for RAYALDEE increased by 89% compared to Q4 2018.
4Kscore test received final Local Coverage Determination for Medicare payments.
Consolidated revenues increased to $224.3 million compared to the same period in 2018.
Revenue by Segment
Forward Guidance
OPKO Health anticipates regulatory submission in the U.S. for Somatrogon in 2H 2020, with Europe expected to follow upon completion of an open-label study in Q3 2020. The registration study in pediatric GHD patients in Japan is on track for completion in Q1 2020. An interim readout of the Phase 2 trial with RAYALDEE in adults with vitamin D insufficiency and stage 5 chronic kidney disease (CKD) requiring dialysis is expected in Q1 2020.
Positive Outlook
- Regulatory submission in the U.S. for Somatrogon anticipated in 2H 2020.
- Europe is expected to follow upon completion of the open-label study in Q3 2020.
- Registration study in pediatric GHD patients in Japan is on track for completion in Q1 2020.
- Interim readout of the Phase 2 trial with RAYALDEE expected in Q1 2020.
- Company entered into an unsecured credit facility providing $100 million of incremental capital on a non-dilutive basis.
Challenges Ahead
- Possibility of unfavorable new clinical data.
- Risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities.
Revenue & Expenses
Visualization of income flow from segment revenue to net income
Historical Earnings Impact
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Avg. Return Before/After Earnings
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