OPK Opko Health

OPKO Health, Inc. engages in the provision of healthcare services. It operates through the following segments: Diagnostics, Pharmaceuticals, and Corporate. The Diagnostics segment include clinical laboratory operations of BioReference, as well as point-of-care operations. The Pharmaceuticals segment includes comprises pharmaceutical operations in Chile, Mexico, Ireland, Israel, and Spain and pharmaceutical research and development operations. The company was founded in October 1991 and is headquartered in Miami, FL.

Company profile

Phillip Frost
Fiscal year end
Former names
IRS number

OPK stock data


Investment data

Data from SEC filings
Securities sold
Number of investors


28 Apr 21
13 Jun 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
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Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
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Financial data from Opko Health earnings reports.

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.65 63,206 230.7K 192,771,694
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.645 62,273 226.99K 192,708,488
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.64 114,631 417.26K 192,646,215
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.639 13,200 48.03K 192,531,584
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.635 109,064 396.45K 192,518,384
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.63 30,366 110.23K 192,409,320
25 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.625 7,260 26.32K 192,378,954
10 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.74 25,000 93.5K 192,371,694
10 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.63 25,000 90.75K 192,346,694
10 May 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.58 24,000 85.92K 192,321,694

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

27.7% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 230 236 -2.5%
Opened positions 41 53 -22.6%
Closed positions 47 24 +95.8%
Increased positions 79 59 +33.9%
Reduced positions 62 69 -10.1%
13F shares
Current Prev Q Change
Total value 1.53B 968.49M +58.3%
Total shares 185.45M 186.99M -0.8%
Total puts 2.13M 3.34M -36.2%
Total calls 3.6M 6.22M -42.1%
Total put/call ratio 0.6 0.5 +10.3%
Largest owners
Shares Value Change
BLK Blackrock 38.72M $166.12M +2.9%
Vanguard 35.49M $152.23M +3.0%
STT State Street 19.31M $82.84M -15.6%
Oracle Investment Management 12.82M $55M -2.7%
Geode Capital Management 7.53M $32.29M +9.2%
Dimensional Fund Advisors 7.39M $31.64M +31.7%
NTRS Northern Trust 5.84M $25.03M -22.3%
Charles Schwab Investment Management 3.62M $15.51M +2.5%
D. E. Shaw & Co. 3.54M $15.17M +11511.6%
GS Goldman Sachs 3.14M $13.49M -19.2%
Largest transactions
Shares Bought/sold Change
Norges Bank 0 -4.39M EXIT
STT State Street 19.31M -3.56M -15.6%
D. E. Shaw & Co. 3.54M +3.51M +11511.6%
Dimensional Fund Advisors 7.39M +1.78M +31.7%
NTRS Northern Trust 5.84M -1.67M -22.3%
IVZ Invesco 2.16M -1.67M -43.6%
Hennion & Walsh Asset Management 1.65M +1.65M NEW
FMR 1.32M +1.32M NEW
BLK Blackrock 38.72M +1.09M +2.9%
Vanguard 35.49M +1.03M +3.0%

Financial report summary

  • Our business has been, and may continue to be, affected by the coronavirus disease 2019 (COVID-19) outbreak.
  • We have had a history of operating losses and may not be able to sustain profitability in the near future.
  • We may require additional funding, which may not be available to us on acceptable terms, or at all.
  • Our research and development activities may not result in commercially viable products.
  • The results of pre-clinical trials and previous clinical trials for our products may not be predictive of future results, and our current and planned clinical trials may not satisfy the requirements of the FDA or other non-U.S. regulatory authorities.
  • We rely on licensing agreements with Vifor Fresenius Medical Renal Care Pharma Ltd (“VFMCRP”) and Japan Tobacco (“JT”) for the international development and marketing of Rayaldee. Failure to maintain these license agreements could prevent us from successfully developing and commercializing Rayaldee worldwide.
  • Our exclusive worldwide agreement with Pfizer Inc. is important to our business. If we do not successfully develop hGH- CTP (somatrogon) and/or Pfizer Inc. does not successfully commercialize hGH-CTP (somatrogon), our business could be adversely affected.
  • Our business is substantially dependent on our ability to achieve regulatory approval for the marketing of hGH-CTP (somatrogon) in pediatric and adult patients and the commercial success of this product.
  • Protein therapeutics have the potential to cause an immune or antibody response in patients.
  • Our business is dependent on our ability to develop, launch and generate revenue from our diagnostic products.
  • Discontinuation or recalls of existing testing products, failure to develop, or acquire, licenses for new or improved testing technologies or our clients using new technologies to perform their own tests could adversely affect our business.
  • If our competitors develop and market products or services that are more effective, safer or less expensive than our current and future products or services, our revenues, profitability and commercial opportunities will be negatively impacted.
  • Our product development activities could be delayed or stopped.
  • Our inability to meet regulatory quality standards applicable to our manufacturing and quality processes and to address quality control issues in a timely manner could delay the production and sale of our products or result in recalls of products.
  • Failure to establish, and perform to, appropriate quality standards to assure that the highest level of quality is observed in the performance of our testing services could adversely affect the results of our operations and adversely impact our reputation.
  • Even after we receive regulatory approval or clearance to market our product candidates, the market may not be receptive to our products.
  • If our products are not covered and eligible for reimbursement from government and third party payors, we may not be able to generate significant revenue or achieve or sustain profitability.
  • As we evolve from a company primarily involved in development to a company also involved in commercialization of our pharmaceutical and diagnostic products as well as our laboratory testing services, we may encounter difficulties in managing our growth and expanding our operations successfully.
  • Our success is dependent to a significant degree upon the involvement, efforts and reputation of our Chairman and Chief Executive Officer, Phillip Frost, M.D.
  • If we fail to attract and retain key management and scientific personnel, we may be unable to successfully operate our business and develop or commercialize our products and product candidates.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sale of our products or product candidates may be adversely affected.
  • We rely on third parties to manufacture and supply our pharmaceutical and diagnostic products and product candidates.
  • Independent clinical investigators and contract research organizations that we engage to conduct our clinical trials may not be diligent, careful or timely.
  • If the validity of an informed consent from a subject was to be challenged, it may negatively impact our product development efforts.
  • Failure to timely or accurately bill and collect for our services could have a material adverse effect on our revenues and our business.
  • The information technology systems that we rely on may be subject to unauthorized tampering, cyberattack or other data security incidents that could impact our billing processes or disrupt our operations
  • Healthcare plans have taken steps to control the utilization and reimbursement of healthcare services, including clinical test services.
  • If we are unable to obtain and enforce patent protection for our products, our business could be materially harmed.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
  • We will rely heavily on licenses from third parties. Failure to comply with the provisions of these licenses could result in the loss of our rights under the license agreements.
  • We license patent rights to certain of our technology from third-party owners. If such owners do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
  • If we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our product development and commercialization efforts.
  • We have faced, and may in the future face, intellectual property infringement claims that could be time-consuming and costly to defend, and could result in our loss of significant rights and the assessment of treble damages.
  • We may become subject to product liability for our diagnostic tests, clinical trials, pharmaceutical products and medical device products.
  • Adverse results in material litigation matters or governmental inquiries could have a material adverse effect upon our business and financial condition.
  • Our ability to successfully operate our laboratories and develop and commercialize certain of our diagnostic tests and LDTs will depend on our ability to maintain required regulatory licensures and comply with all the CLIA requirements.
  • The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our product candidates.
  • The terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products and product candidates, which could materially impair our ability to generate anticipated revenues.
  • If we fail to comply with complex and rapidly evolving laws and regulations, we could suffer penalties, be required to pay substantial damages or make significant changes to our operations.
  • Failure to maintain the security of patient-related information or compliance with security requirements could damage our reputation with customers, cause us to incur substantial additional costs and become subject to litigation.
  • Failure to comply with environmental, health and safety laws and regulations, including the Federal Occupational Safety and Health Administration Act, the Needlestick Safety and Prevention Act and the Comprehensive Medical Waste Management Act, could result in fines and penalties and loss of licensure, and have a material adverse effect upon our business.
  • Our failure or the failure of third-party payors or physicians to comply with ICD-10-CM Code Set, and our failure to comply with other emerging electronic transaction standards could adversely impact our business.
  • Failure to comply with complex federal and state laws and regulations related to submission of claims for clinical laboratory services could result in significant monetary damages and penalties and exclusion from the Medicare and Medicaid programs.
  • Changes in regulation and policies, including increasing downward pressure on health care reimbursement, may adversely affect reimbursement for diagnostic services and could have a material adverse impact on our business.
  • Medicare legislation and future legislative or regulatory reform of the health care system may affect our ability to sell our products profitably.
  • Failure to obtain regulatory approval outside the U.S. will prevent us from marketing our products and product candidates abroad.
  • Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.
  • Potential political, economic and military instability in the State of Israel, where we have office, laboratory and manufacturing operations, may adversely affect our results of operations.
  • Due to the international scope of our business activities, our results of operations may be significantly affected by currency fluctuations.
  • We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business.
  • We are subject to risks associated with doing business globally.
  • We have a large amount of goodwill and other intangible assets on our balance sheet that are subject to periodic impairment evaluations.
  • The trading prices of our securities may fluctuate significantly.
  • Directors, executive officers, principal stockholders and affiliated entities own a substantial amount of our capital stock, and they may make decisions that you do not consider to be in the best interests of our stockholders.
  • A significant short position in our stock could have a substantial impact on the trading price of our stock.
  • Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act, including with respect to companies we acquire, could have a material adverse effect on our business and operating results. In addition, current and potential stockholders could lose confidence in our financial reporting, which could have a material adverse effect on the price of our Common Stock.
  • Compliance with changing regulations concerning corporate governance and public disclosure may result in additional expenses.
Management Discussion
  • We are a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Our diagnostics business includes BioReference Laboratories, Inc. (“BioReference”), one of the nation’s largest full service laboratories with a core genetic testing business and an almost 300-person sales and marketing team to drive growth and leverage new products, including the 4Kscore test. Our pharmaceutical business features Rayaldee, a U.S. Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency (launched in November 2016) and a pipeline of products in various stages of development. Our leading product in development is hGH-CTP (Somatrogon), a once-weekly human growth hormone for which we have partnered with Pfizer, Inc. (“Pfizer”). Regulatory applications for hGH-CTP (Somatrogon) approval have been submitted in the U.S., Europe and Japan, among other territories. We are incorporated in Delaware, and our principal executive offices are located in leased offices in Miami, Florida.
  • Through BioReference, we provide laboratory testing services, primarily to customers in the larger metropolitan areas in New York, New Jersey, Florida, Texas, Maryland, California, Pennsylvania, Delaware, Washington, DC, Illinois and Massachusetts, as well as to customers in a number of other states. We offer a comprehensive test menu of clinical diagnostics for blood, urine and tissue analysis. This includes hematology, clinical chemistry, immunoassay, infectious diseases, serology, hormones, and toxicology assays, as well as Pap smear, anatomic pathology (biopsies) and other types of tissue analysis. We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities.
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