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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

Ticker
OPK
Exchange
Website
CEO
Phillip Frost
Employees
Incorporated
Location
Fiscal year end
Former names
CYTOCLONAL PHARMACEUTICS INC /DE, EXEGENICS INC, eXegenics Inc
SEC CIK
IRS number
752402409

OPK stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

18 Feb 21
11 Apr 21
31 Dec 21
Quarter (USD)
Dec 20 Sep 20 Jun 20 Mar 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from Opko Health earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 72.21M 72.21M 72.21M 72.21M 72.21M 72.21M
Cash burn (monthly) (positive/no burn) 1.1M (positive/no burn) (positive/no burn) (positive/no burn) (positive/no burn)
Cash used (since last report) n/a 3.74M n/a n/a n/a n/a
Cash remaining n/a 68.47M n/a n/a n/a n/a
Runway (months of cash) n/a 62.1 n/a n/a n/a n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.97 21,200 84.16K 192,171,694
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.969 8,800 34.93K 192,150,494
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.96 17,069 67.59K 192,141,694
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.95 40,572 160.26K 192,124,625
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.949 11,100 43.83K 192,084,053
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.945 200 789 192,072,953
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.94 27,059 106.61K 192,072,753
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.92 14,000 54.88K 192,045,694
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.91 18,340 71.71K 192,031,694
5 Mar 21 Phillip MD Frost Et Al Common Stock Buy Aquire P Yes No 3.9 1,160 4.52K 192,013,354

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

27.9% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 236 207 +14.0%
Opened positions 53 40 +32.5%
Closed positions 24 34 -29.4%
Increased positions 59 70 -15.7%
Reduced positions 69 58 +19.0%
13F shares
Current Prev Q Change
Total value 985.25M 1.05B -5.9%
Total shares 187.23M 190.3M -1.6%
Total puts 3.34M 2.9M +15.3%
Total calls 6.22M 4.33M +43.5%
Total put/call ratio 0.5 0.7 -19.7%
Largest owners
Shares Value Change
BLK Blackrock 37.63M $148.63M +3.5%
Vanguard 34.45M $136.08M -3.9%
STT State Street 22.87M $90.33M -8.9%
Oracle Investment Management 13.17M $52.03M -1.4%
NTRS Northern Trust 7.51M $29.66M -3.2%
Geode Capital Management 6.89M $27.22M +3.9%
Dimensional Fund Advisors 5.61M $22.17M +10.4%
Norges Bank 4.39M $17.33M NEW
GS Goldman Sachs 3.89M $15.37M -22.7%
IVZ Invesco 3.83M $15.14M +44.1%
Largest transactions
Shares Bought/sold Change
Norges Bank 4.39M +4.39M NEW
Trellus Management 0 -2.59M EXIT
STT State Street 22.87M -2.23M -8.9%
UBS UBS Group AG - Registered Shares 714.76K -1.88M -72.5%
Altshuler Shaham 0 -1.58M EXIT
Vanguard 34.45M -1.41M -3.9%
BLK Blackrock 37.63M +1.29M +3.5%
Nordea Investment Management Ab 1.27M +1.27M NEW
IVZ Invesco 3.83M +1.17M +44.1%
First Trust Advisors 1.17M +1.17M NEW

Financial report summary

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Risks
  • 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
  • Revenue. Revenue from services for the year ended December 31, 2020 increased by approximately $545.8 million compared to the year ended December 31, 2019, due to COVID-19 testing volumes. BioReference performed 0.8 million serology antibody tests and 10.1 million diagnostic molecular tests for COVID-19 during the year ended December 31, 2020, which represented 57% of total testing volume. Revenue attributable to tests for COVID-19 was partially offset by the negative impacts of:
  • •A reduction in clinical test volumes and genomic test volumes at BioReference resulted in decreased revenues of $99.5 million and $15.6 million, respectively, as compared to the year ended December 31, 2019. The decline in routine clinical and genomic testing volume reflects negative impacts from the COVID-19 pandemic, principally from referring physician office closures and stay-at-home guidance throughout states in which we predominately operate.
  • •A reduction in clinical test and genomic test reimbursement at BioReference of $10.2 million and $27.6 million, respectively, as compared to the year ended December 31, 2019. The lower reimbursement within our clinical business was primarily the result of the negative impact of the PAMA price reduction that went into effect January 1, 2020 combined with an overall shift in our test mix that was partially offset by increased reimbursement of our 4KScore test. The lower reimbursement within our genomic business resulted from an increase in denial rates and changes to payor policy and procedural requirements.
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