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Opko Health (OPK)

Opko Health Inc. is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

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
Subsidiaries
OPKO Instrumentation, LLC • OPKO Pharmaceuticals, LLC • OPKO Diagnostics, LLC • OPKO Chile, S.A. • Arama Natural Products Distribuidora, Ltda • Pharmacos Exakta S.A. de C.V. • FineTech Pharmaceutical Ltd • OPKO Health Europe, S.L. • OPKO Biologics, Ltd • OPKO Ireland Global Holdings, Ltd ...
IRS number
752402409

OPK stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

4 Aug 22
12 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 210.46M 210.46M 210.46M 210.46M 210.46M 210.46M
Cash burn (monthly) (no burn) (no burn) 3.58M 9.04M 3.83M 298.42K
Cash used (since last report) n/a n/a 5.19M 13.11M 5.55M 432.92K
Cash remaining n/a n/a 205.26M 197.35M 204.91M 210.03M
Runway (months of cash) n/a n/a 57.3 21.8 53.6 703.8

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.32 7,003 16.25K 196,956,694
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.315 43,656 101.06K 196,949,691
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.31 804 1.86K 196,906,035
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.305 11,375 26.22K 196,905,231
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.3 69,986 160.97K 196,893,856
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.299 3,500 8.05K 196,823,870
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.2984 2,364 5.43K 196,820,370
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.2975 600 1.38K 196,818,006
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.295 52,210 119.82K 196,817,406
5 Aug 22 Phillip MD Frost Et Al Common Stock Buy Acquire P Yes No 2.29 24,400 55.88K 196,765,196
49.9% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 227 233 -2.6%
Opened positions 35 50 -30.0%
Closed positions 41 25 +64.0%
Increased positions 53 56 -5.4%
Reduced positions 71 61 +16.4%
13F shares Current Prev Q Change
Total value 1.15B 1.41B -18.4%
Total shares 384.96M 383.85M +0.3%
Total puts 4.14M 5.89M -29.8%
Total calls 2.45M 6.39M -61.8%
Total put/call ratio 1.7 0.9 +83.6%
Largest owners Shares Value Change
Phillip MD Frost Et Al 189.33M $482.78M 0.0%
Vanguard 36.07M $124.09M +1.0%
BLK Blackrock 33.87M $116.51M -1.5%
STT State Street 27.69M $95.25M +56.7%
Oracle Investment Management 8.99M $30.91M -26.5%
Geode Capital Management 7.77M $26.72M +0.5%
Dimensional Fund Advisors 7.18M $24.72M +73.2%
NTRS Northern Trust 5.73M $19.73M -8.0%
D. E. Shaw & Co. 5.38M $18.49M +31.7%
Hsiao Jane PH D 5.13M $8.77M 0.0%
Largest transactions Shares Bought/sold Change
STT State Street 27.69M +10.01M +56.7%
Point72 Asset Management 589.1K -6.07M -91.1%
Norges Bank 0 -4.28M EXIT
Oracle Investment Management 8.99M -3.23M -26.5%
Dimensional Fund Advisors 7.18M +3.04M +73.2%
Susquehanna International 1.21M -2.76M -69.4%
IVZ Invesco 2.58M +2.14M +485.5%
MS Morgan Stanley 2.62M +1.76M +204.3%
PXGPE Phoenix 1.33M +1.33M NEW
D. E. Shaw & Co. 5.38M +1.29M +31.7%

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, Nicoya, and international partners 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 is important to our business. If we do not successfully develop Somatrogon (hGH- CTP)and/or Pfizer does not successfully commercialize Somatrogon (hGH-CTP ), our business could be adversely affected.
  • Our business is substantially dependent on our ability to achieve regulatory approval for the marketing of Somatrogon (hGH-CTP) 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.
  • Business combinations may disrupt our business, distract our management, may not proceed as planned, and may also increase the risk of potential third party claims and litigation.
  • We may fail to realize the anticipated benefits of the sale of GeneDx and we could recognize an impairment charge in the future, depending on Sema4’s stock price when the transaction closes.
  • 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
  • ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
  • 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 Health LLC, formerly BioReference Laboratories, Inc. (“BioReference”), one of the nation’s largest full service laboratories with an almost 250-person sales and marketing team to drive growth and leverage new products. 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 and a pipeline of products in various stages of development. Our leading product in development is Somatrogon (hGH-CTP), a once-weekly human growth hormone for which we have partnered with Pfizer, Inc. (“Pfizer”) and successfully completed a phase 3 study in August 2019. Regulatory applications for Somatrogon (hGH-CTP) have been submitted to several countries around the world for review. In February 2022, the European Commission granted marketing authorization in the European Union for Somatrogon (hGH-CTP) under the brand name NGENLA® to treat children and adolescents from as young as three years of age with growth disturbance due to insufficient secretion of growth hormone and we received pricing approval in Germany in April 2022. In January 2022, the Ministry of Health, Labour and Welfare in Japan approved NGENLA® (Somatrogon) for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone and we received pricing approval in April 2022. In October 2021, Health Canada approved NGENLA® for the long-term treatment of pediatric patients who have growth hormone deficiency, and Australia’s Therapeutic Goods Administration approved NGENLA® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Pfizer also submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon (hGH-CTP) in the United States, and received a Complete Response Letter in January 2022. Pfizer and OPKO are evaluating the FDA’s comments and will work with the agency to determine the best path forward for Somatrogon (hGH-CTP) in the United States. 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.

Content analysis

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Positive
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Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Avg
New words: admitted, assembled, assigned, Beckman, cancer, CIA, CMC, Committee, Connecticut, Coulter, Danaher, Defense, designee, DNA, education, escrow, escrowed, exceeded, family, FGIT, forfeited, immune, imposition, indemnity, independent, Inspector, instance, instituting, intention, investee, Leica, lockup, monetarily, nominee, oversight, piggyback, preliminary, recipient, recommendation, refrain, register, resale, return, revocation, robust, seeking, shelf, smaller, spend, standstill, survived, surviving, training, unvested, workforce, written
Removed: calculated, called, constructing, Endowment, equipping, exome, genome, Horizon, housed, impacted, intensive, issue, Museum, neonatal, onboarding, Pediatrix, Pfenniger, planned, plc, positively, Science, sequencing, staffed, subspecialty, surgical, thereunder

Patents

Utility
Treatment of Sirtuin (SIRT) related diseases by inhibition of natural antisense transcript to a Sirtuin (SIRT)
9 Aug 22
The present invention relates to antisense oligonucleotide that modulate the expression of and/or function of a Sirtuin (SIRT), in particular, by targeting natural antisense polynucleotides of a Sirtuin (SIRT).
Utility
Treatment of filaggrin (FLG) related diseases by modulation of FLG expression and activity
19 Jul 22
The present invention relates to antisense oligonucleotides and/or compounds that modulate the expression of and/or function of Filaggrin (FLG), in particular, by targeting natural antisense polynucleotides of Filaggrin (FLG).
Utility
Treatment of Glial Cell Derived Neurotrophic Factor (GDNF) Related Diseases by Inhibition of Natural Antisense Transcript to GDNF
23 Jun 22
The present invention relates to antisense oligonucleotides that modulate the expression of and/or function of Glial cell derived neurotrophic factor (GDNF), in particular, by targeting natural antisense polynucleotides of Glial cell derived neurotrophic factor (GDNF).
Utility
Treatment of collagen gene related diseases by inhibition of natural antisense transcript to a collagen gene
24 May 22
The present invention relates to antisense oligonucleotides that modulate the expression of and/or function of a Collagen gene, in particular, by targeting natural antisense polynucleotides of a Collagen gene.
Utility
Stabilized modified release Vitamin D formulation and method of administering same
22 Feb 22
A stabilized formulation for controlled release of a vitamin D compound is disclosed.