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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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75-2402409
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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4400 Biscayne Blvd., Miami, FL 33137
(Address of Principal Executive Offices) (Zip Code) |
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(Registrant
’
s Telephone Number, Including Area Code): (305) 575-4100
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Securities registered pursuant to section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $.01 par value per share
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NASDAQ Global Select Market
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(in Rule 12b-2 of the Exchange Act) (Check one):
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Page
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Part I.
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Part II.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Part III.
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Item 10.
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Directors, Executive Officers and Corporate Governance
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Item 11.
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Executive Compensation
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
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Item 13.
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Certain Relationships and Related Transactions and Director Independence
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Item 14.
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Principal Accounting Fees and Services
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Part IV.
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Item 15.
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Signatures
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Certifications
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EX-21
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EX-23.1
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EX-31.1
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EX-31.2
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EX-32.1
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EX-32.2
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EX-101. INS XBRL Instance Document
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EX-101.SCH XBRL Taxonomy Extension Schema Document
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EX-101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
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EX-101.DEF XBRL Taxonomy Extension Definition Linkbase Document
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EX-101.LAB XBRL Taxonomy Extension Label Linkbase Document
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EX-101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
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we have a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs;
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the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments;
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our research and development activities may not result in commercially viable products;
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that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results;
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that we may fail to obtain regulatory approval for hGH-CTP or successfully commercialize
Rayaldee
and hGH-CTP;
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that we may not generate profits or cash flow from our laboratory operations or substantial revenue from our pharmaceutical and diagnostic products;
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that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied;
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our ability to build a successful pharmaceutical sales and marketing infrastructure;
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our ability and our distribution and marketing partners’ ability to comply with regulatory requirements regarding the sales, marketing and manufacturing of our products and product candidates and the operation of our laboratories;
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the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control;
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our success is dependent on the involvement and continued efforts of our Chairman and Chief Executive Officer;
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integration challenges for Transition Therapeutics, BioReference, EirGen and other acquired businesses;
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changes in regulation and policies in the United States and other countries, including increasing downward pressure on healthcare reimbursement;
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our ability to manage our growth and our expanded operations;
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increased competition, including price competition;
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changing relationships with payers, including the various state and multi-state Blues programs, suppliers and strategic partners;
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efforts by third-party payors to reduce utilization and reimbursement for clinical testing services;
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failure to timely or accurately bill and collect for our services;
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failure in our information technology systems, including cybersecurity attacks or other data security or privacy incidents;
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failure to obtain and retain new clients and business partners, or a reduction in tests ordered or specimens submitted by existing clients;
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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;
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failure to maintain the security of patient-related information;
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our ability to obtain and maintain intellectual property protection for our products;
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our ability to defend our intellectual property rights with respect to our products;
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our ability to operate our business without infringing the intellectual property rights of others;
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our ability to attract and retain key scientific and management personnel;
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our need for, and ability to obtain, additional financing;
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adverse results in material litigation matters or governmental inquiries;
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failure to obtain and maintain regulatory approval outside the U.S.;
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legal, economic, political, regulatory, currency exchange, and other risks associated with international operations; and
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our ability to finance and successfully complete construction of a research, development and manufacturing center in Waterford, Ireland.
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ITEM 1.
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BUSINESS
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continue to enhance our commercialization capability in the U.S. and internationally;
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develop and commercialize
Rayaldee
for new indications, including the treatment of SHPT in patients with vitamin D insufficiency and stage 5 CKD requiring regular hemodialysis;
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obtain requisite regulatory approval and compile clinical data for our most advanced product candidates; and
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expand into other medical markets that provide significant opportunities and that we believe are complementary to and synergistic with our business.
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Products and technologies.
We intend to continue to pursue product and technology acquisitions and licenses that will complement our existing businesses and provide new product and market opportunities, enhance our profitability, leverage our existing assets, and contribute to our own organic growth.
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Commercial businesses.
We intend to continue to pursue acquisitions of commercial businesses that will both drive our growth and provide geographically diverse sales and distribution opportunities.
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Early stage investments.
We have and may continue to make investments in early stage companies that we perceive to have valuable proprietary technology and significant potential to create value for OPKO as a shareholder.
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BioReference Laboratories.
BioReference constitutes our core clinical testing laboratory offering automated, high volume routine testing services, STAT testing, informatics, HIV, Hep C and other molecular tests.
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GenPath (Oncology).
National oncology presence with expertise in cancer pathology and diagnostics, as well as molecular diagnostics. Core tests include FLOW, IHC, MicroArray, FISH, ISH, Morphology, and full service oncology.
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GenPath (Women’s Health).
Innovative technology platform for sexually transmitted infections has enabled expansion nationally with specimens coming from 41 states, including Image Directed Paps analysis, HPV Plus, and STI Testing.
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GeneDx.
Industry leading national laboratory for testing rare and ultra-rare genetic diseases with international reach, performing testing on specimens from more than 50 countries.
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Laboratorio Bueno Salud
. National testing laboratory dedicated to serving the Spanish-speaking population in the United States, where all business is conducted in Spanish including patient and physician interaction.
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our ability to meet all necessary regulatory requirements to advance our product candidates through clinical trials and the regulatory approval process in the U.S. and abroad;
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the perception by physicians and other members of the health care community of the safety, efficacy, and benefits of our products compared to those of competing products or therapies;
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our ability to manufacture products we may develop on a commercial scale;
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the effectiveness of our sales and marketing efforts;
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the willingness of physicians to adopt a new diagnostic or treatment regimen represented by our technology;
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our ability to secure reimbursement for our product candidates;
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the price of the products we may develop and commercialize relative to competing products;
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our ability to accurately forecast and meet demand for our product candidates if regulatory approvals are achieved;
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our ability to develop a commercial scale infrastructure either on our own or with a collaborator, which would include expansion of existing facilities, including our manufacturing facilities, development of a sales and distribution network, and other operational and financial systems necessary to support our increased scale;
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our ability to maintain a proprietary position in our technologies; and
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our ability to rapidly expand the existing information technology infrastructure and configure existing operational, manufacturing, and financial systems (on our own or with third party collaborators) necessary to support our increased scale, which would include existing or additional facilities and or partners.
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the circumstances under which uses and disclosures of PHI are permitted or required without a specific authorization by the patient, including but not limited to treatment purposes, to obtain payments for services and health care operations activities;
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a patient’s rights to access, amend and receive an accounting of certain disclosures of PHI;
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the content of notices of privacy practices for PHI; and
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administrative, technical and physical safeguards required of entities that use or receive PHI electronically.
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Makes clear that situations involving impermissible access, acquisition, use or disclosure of protected health information are now presumed to be a breach unless the covered entity or business associate is able to demonstrate that there is a low probability that the information has been compromised;
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Defines the term “business associate” to include subcontractors and agents that receive, create, maintain or transmit protected health information on behalf of the business associate;
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Establishes new parameters for covered entities and business associates on uses and disclosures of PHI for fundraising and marketing; and
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Establishes clear restrictions on the sale of PHI without patient authorization.
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be found to be ineffective, unreliable, or otherwise inadequate or otherwise fail to receive regulatory approval;
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be difficult or impossible to manufacture on a commercial scale;
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be uneconomical to market or otherwise not be effectively marketed;
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fail to be successfully commercialized if adequate reimbursement from government health administration authorities, private health insurers, and other organizations for the costs of these products is unavailable;
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be impossible to commercialize because they infringe on the proprietary rights of others or compete with products marketed by others that are superior; or
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fail to be commercialized prior to the successful marketing of similar products by competitors.
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safety, efficacy, convenience and cost-effectiveness of our products compared to products of our competitors;
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scope of approved uses and marketing approval;
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availability of patent or regulatory exclusivity;
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timing of market approvals and market entry;
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ongoing regulatory obligations following approval;
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any restrictions or “black box” warnings required on the labeling of such products:
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availability of alternative products from our competitors;
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acceptance of the price of our products;
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effectiveness of our sales forces and promotional efforts;
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the level of reimbursement of our products;
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acceptance of our products on government and private formularies;
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ability to market our products effectively at the retail level or in the appropriate setting of care; and
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the reputation of our products.
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▪
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our ability to establish and maintain adequate infrastructure to support the commercial launch and sale of our diagnostic tests, including establishing adequate laboratory space, information technology infrastructure, sample collection and tracking systems, electronic ordering and reporting systems and other infrastructure and hiring adequate laboratory and other personnel;
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the success of the validation studies for our diagnostic tests under development and our ability to publish study results in peer-reviewed journals;
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the availability of alternative and competing tests or products and technological innovations or other advances in medicine that cause our technologies to be less competitive;
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the accuracy rates of such tests, including rates of false-negatives and/or false-positives;
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concerns regarding the safety or effectiveness or clinical utility of our diagnostic tests;
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changes in the regulatory environment affecting health care and health care providers, including changes in laws regulating laboratory testing and/or device manufacturers;
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the extent and success of our sales and marketing efforts and ability to drive adoption of our diagnostic tests;
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coverage and reimbursement levels by government payors and private insurers;
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pricing pressures and changes in third-party payor reimbursement policies; and
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intellectual property rights held by others or others infringing our intellectual property rights.
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a limited number of, and competition for, suitable patients with the particular types of disease required for enrollment in our clinical trials or that otherwise meet the protocol’s inclusion criteria and do not meet any of the exclusion criteria;
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a limited number of, and competition for, suitable serum or other samples from patients with particular types of disease required for our validation studies;
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a limited number of, and competition for, suitable sites to conduct our clinical trials;
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delay or failure to obtain FDA or other non-U.S. regulatory authorities’ approval or agreement to commence a clinical trial;
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delay or failure to obtain sufficient supplies of the product candidate for our clinical trials;
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requirements to provide the drugs, diagnostic tests, or medical devices required in our clinical trial protocols or clinical trials at no cost or cost, which may require significant expenditures that we are unable or unwilling to make;
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delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or investigators;
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delay or failure to obtain institutional review board (“IRB”) approval to conduct or renew a clinical trial at a prospective site; and
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insufficient liquidity to fund our preclinical and clinical studies.
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slower than expected rates of patient recruitment and enrollment;
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failure of patients to complete the clinical trial;
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unforeseen safety issues;
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lack of efficacy evidenced during clinical trials;
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termination of our clinical trials by one or more clinical trial sites;
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inability or unwillingness of patients or medical investigators to follow our clinical trial protocols;
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inability to monitor patients adequately during or after treatment; and
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insufficient liquidity to fund ongoing studies.
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regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication, or field alerts to physicians and pharmacies;
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regulatory authorities may withdraw their approval of the product and require us to take our approved product off the market;
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we may be required to change the way the product is administered, conduct additional clinical trials, or change the labeling of the product;
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we may have limitations on how we promote our products;
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sales of products may decrease significantly;
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we may be subject to litigation or product liability claims; and
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our reputation may suffer.
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timing of market introduction of competitive products;
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safety and efficacy of our product compared to other products;
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prevalence and severity of any side effects;
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potential advantages or disadvantages over alternative treatments;
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strength of marketing and distribution support;
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price of our products, both in absolute terms and relative to alternative treatments;
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availability of coverage and reimbursement from government and other third-party payors;
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potential product liability claims;
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limitations or warnings contained in a product’s regulatory authority-approved labeling; and
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changes in the standard of care for the targeted indications for any of our products or product candidates, which could reduce the marketing impact of any claims that we could make following applicable regulatory authority approval.
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restrictions on the products, manufacturers, or manufacturing process;
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adverse inspectional observations (Form 483), warning letters, or non-warning letters incorporating inspectional observations;
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civil and criminal penalties;
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injunctions;
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suspension or withdrawal of regulatory approvals or clearances;
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product seizures, detentions, or import bans;
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voluntary or mandatory product recalls and publicity requirements;
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total or partial suspension of production;
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imposition of restrictions on operations, including costly new manufacturing requirements; and
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refusal to approve or clear pending NDAs or supplements to approved NDAs, applications or pre-market notifications.
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a drug candidate may not be deemed safe or effective;
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a medical device candidate may not be deemed to be substantially equivalent to a lawfully marketed non-PMA device, in the case of a premarket notification;
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the FDA may not find the data from pre-clinical studies and clinical trials sufficient;
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the FDA may not approve our or our third-party manufacturer’s processes or facilities; or
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the FDA may change its approval or clearance policies or adopt new regulations.
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federal and state laws applicable to billing and claims payment;
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federal and state laboratory anti-mark-up laws;
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federal and state anti-kickback laws;
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physician self-referral law;
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federal and state false claims laws;
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federal self-referral and financial inducement prohibition laws, commonly known as the Stark Law, and the state equivalents;
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federal and state laws governing laboratory licensing and testing, including CLIA;
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federal and state laws governing the development, use and distribution of LDTs;
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HIPAA, along with the revisions to HIPAA as a result of the HITECH Act, and analogous state laws and non-US laws, including the General Data Protection Regulation;
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federal, state and foreign regulation of privacy, security, electronic transactions and identity theft;
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federal, state and local laws governing the handling, transportation and disposal of medical and hazardous waste;
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Occupational Safety and Health Administration rules and regulations;
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changes to laws, regulations and rules as a result of the implementation and/or repeal of part or all of 2010 Health Care Reform Legislation; and
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changes to other federal, state and local laws, regulations and rules, including tax laws.
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difficulty integrating acquired technologies, products, services, operations, and personnel with the existing businesses;
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diversion of management’s attention in connection with both negotiating the acquisitions and integrating the businesses;
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strain on managerial and operational resources as management tries to oversee larger operations and investments;
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difficulty implementing and maintaining effective internal control over financial reporting at businesses that we acquire or invest in, particularly if they are not located near our existing operations;
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exposure to unforeseen liabilities of acquired companies or companies in which we invest;
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potential costly and time-consuming litigation, including stockholder lawsuits;
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potential issuance of securities to equity holders of the company being acquired with rights that are superior to the rights of holders of our Common Stock, or which may have a dilutive effect on our stockholders;
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the need to incur additional debt or use cash; and
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the requirement to record potentially significant additional future operating costs for the amortization of intangible assets.
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combining the companies’ operations and corporate functions, as well as obtaining anticipated synergies;
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combining our business with BioReference’s business and meeting the capital requirements of the combined company, in a manner that permits us to achieve the cost savings or revenue synergies anticipated to result from the merger, the failure of which would result in the anticipated benefits of the merger not being realized in the time frame currently anticipated or at all;
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integrating the companies’ technologies;
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integrating and unifying the offerings and services available to customers;
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identifying and eliminating redundant and underperforming functions and assets;
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harmonizing and/or addressing differences in the companies’ operating practices, employee development and compensation programs, internal controls and other policies, procedures and processes;
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maintaining existing agreements with customers, distributors, providers and vendors and avoiding delays in entering into new agreements with prospective customers, distributors, providers and vendors;
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addressing possible differences in business backgrounds, corporate cultures and management philosophies;
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consolidating the companies’ administrative and information technology infrastructure;
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coordinating distribution and marketing efforts;
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managing the movement of certain positions to different locations;
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coordinating geographically dispersed organizations; and
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effecting actions that may be required in connection with obtaining regulatory approvals.
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the announcement of new products or product enhancements by us or our competitors;
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results of our clinical trials and other development efforts;
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developments concerning intellectual property rights and regulatory approvals;
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variations in our and our competitors’ results of operations;
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changes in earnings estimates or recommendations by securities analysts, if our Common Stock is covered by analysts;
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developments in the biotechnology, pharmaceutical, diagnostic, and medical device industry;
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the results of product liability or intellectual property lawsuits;
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future issuances of our Common Stock or other securities, including debt;
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purchases and sales of our Common Stock by our officers, directors or affiliates;
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the addition or departure of key personnel;
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announcements by us or our competitors of acquisitions, investments, or strategic alliances; and
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general market conditions and other factors, including factors unrelated to our operating performance.
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Location
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Segment and Purpose
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Type of Occupancy
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Miami, FL
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Diagnostics & Pharmaceutical: Corporate Headquarters
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Leased
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Elmwood Park, NJ
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Diagnostics: Main Laboratory
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Leased
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Gaithersburg, MD
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Diagnostics: Genetics Laboratory
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Leased
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Kiryat Gat, Israel
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Pharmaceutical: Research and Development, CTP
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Leased
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Woburn, MA
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Diagnostics
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Leased
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Nesher, Israel
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Pharmaceuticals: API Manufacturing
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Leased
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Guadalajara, Mexico
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Pharmaceuticals: Pharmaceutical Manufacturing
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Owned
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Banyoles, Spain
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Pharmaceuticals: Pharmaceutical Manufacturing
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Owned
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Palol de Revardit, Spain
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Warehouse
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Leased
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Barcelona, Spain
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Pharmaceuticals: Research and Development
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Leased
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Waterford, Ireland
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Pharmaceuticals: Pharmaceutical Manufacturing
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Leased
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Santiago, Chile
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Pharmaceuticals: Office; Warehouse
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Leased
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High
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Low
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||||
2017
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|
|
|
||||
First Quarter
|
$
|
9.55
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|
|
$
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7.13
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Second Quarter
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8.04
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|
|
5.99
|
|
||
Third Quarter
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7.24
|
|
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5.85
|
|
||
Fourth Quarter
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7.08
|
|
|
4.50
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|
||
2016
|
|
|
|
||||
First Quarter
|
$
|
11.85
|
|
|
$
|
7.12
|
|
Second Quarter
|
11.39
|
|
|
8.71
|
|
||
Third Quarter
|
11.31
|
|
|
8.91
|
|
||
Fourth Quarter
|
12.15
|
|
|
8.92
|
|
|
12/31/2012
|
|
12/31/2013
|
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12/31/2014
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12/31/2015
|
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12/31/2016
|
|
12/31/2017
|
||||||||||||
OPKO Health, Inc.
|
$
|
100.00
|
|
|
$
|
175.47
|
|
|
$
|
207.69
|
|
|
$
|
208.94
|
|
|
$
|
193.35
|
|
|
$
|
101.87
|
|
S&P 500
|
100.00
|
|
|
132.39
|
|
|
150.51
|
|
|
152.59
|
|
|
170.84
|
|
|
208.14
|
|
||||||
NASDAQ Biotechnology
|
100.00
|
|
|
174.05
|
|
|
230.33
|
|
|
244.29
|
|
|
194.95
|
|
|
228.29
|
|
|
|
For the years ended December 31,
|
||||||||||||||||||
(In thousands, except share and per share information)
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Statement of operations data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues
|
|
$
|
1,067,503
|
|
|
$
|
1,221,661
|
|
|
$
|
491,738
|
|
|
$
|
91,125
|
|
|
$
|
96,530
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of revenue
|
|
620,130
|
|
|
611,482
|
|
|
235,239
|
|
|
48,009
|
|
|
48,860
|
|
|||||
Operating expenses
|
|
727,435
|
|
|
683,454
|
|
|
354,980
|
|
|
188,931
|
|
|
127,302
|
|
|||||
Total costs and expenses
|
|
1,347,565
|
|
|
1,294,936
|
|
|
590,219
|
|
|
236,940
|
|
|
176,162
|
|
|||||
Operating loss
|
|
(280,062
|
)
|
|
(73,275
|
)
|
|
(98,481
|
)
|
|
(145,815
|
)
|
|
(79,632
|
)
|
|||||
Other income and (expense), net
|
|
4,518
|
|
|
(271
|
)
|
|
(39,517
|
)
|
|
(25,212
|
)
|
|
(24,586
|
)
|
|||||
Income tax benefit (provision)
|
|
(18,855
|
)
|
|
56,115
|
|
|
113,675
|
|
|
(24
|
)
|
|
(1,672
|
)
|
|||||
Net loss
|
|
(308,870
|
)
|
|
(25,083
|
)
|
|
(31,428
|
)
|
|
(174,638
|
)
|
|
(117,346
|
)
|
|||||
Net loss attributable to common shareholders
|
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(30,028
|
)
|
|
$
|
(171,666
|
)
|
|
$
|
(114,827
|
)
|
Loss per share, basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net loss per share
|
|
$
|
(0.55
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.32
|
)
|
Weighted average number of common shares outstanding basic and diluted:
|
|
559,160,565
|
|
|
550,846,553
|
|
|
488,065,908
|
|
|
422,014,039
|
|
|
355,095,701
|
|
|||||
Balance sheet data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Total assets
|
|
$
|
2,584,556
|
|
|
$
|
2,766,619
|
|
|
$
|
2,799,188
|
|
|
$
|
1,267,664
|
|
|
$
|
1,391,516
|
|
Long-term liabilities
|
|
$
|
397,843
|
|
|
$
|
411,515
|
|
|
$
|
567,492
|
|
|
$
|
348,812
|
|
|
$
|
426,687
|
|
Total shareholders’ equity
|
|
$
|
1,885,378
|
|
|
$
|
2,091,808
|
|
|
$
|
1,979,794
|
|
|
$
|
835,741
|
|
|
$
|
872,979
|
|
Revenues
|
For the years ended December 31,
|
|
|
||||||||
(In thousands)
|
2017
|
|
2016
|
|
Change
|
||||||
Revenue from services
|
$
|
889,076
|
|
|
$
|
1,012,129
|
|
|
$
|
(123,053
|
)
|
Revenue from products
|
107,759
|
|
|
83,467
|
|
|
24,292
|
|
|||
Revenue from transfer of intellectual property and other
|
70,668
|
|
|
126,065
|
|
|
(55,397
|
)
|
|||
Total revenues
|
$
|
1,067,503
|
|
|
$
|
1,221,661
|
|
|
$
|
(154,158
|
)
|
Cost of Revenue
|
For the years ended December 31,
|
|
|
||||||||
(In thousands)
|
2017
|
|
2016
|
|
Change
|
||||||
Cost of service revenue
|
$
|
558,953
|
|
|
$
|
564,103
|
|
|
$
|
(5,150
|
)
|
Cost of product revenue
|
61,177
|
|
|
47,379
|
|
|
13,798
|
|
|||
Total cost of revenue
|
$
|
620,130
|
|
|
$
|
611,482
|
|
|
$
|
8,648
|
|
|
For the years ended December 31,
|
||||||
|
2017
|
|
2016
|
||||
External expenses:
|
|
|
|
||||
Phase 3 clinical trials
|
$
|
15,339
|
|
|
$
|
12,161
|
|
Manufacturing expense for biological products
|
47,737
|
|
|
35,985
|
|
||
PMA studies
|
1,089
|
|
|
—
|
|
||
Earlier-stage programs
|
7,620
|
|
|
6,297
|
|
||
Research and development employee-related expenses
|
29,970
|
|
|
28,676
|
|
||
Other internal research and development expenses
|
24,680
|
|
|
30,752
|
|
||
Third-party grants and funding from collaboration agreements
|
(1,249
|
)
|
|
(2,666
|
)
|
||
Total research and development expenses
|
$
|
125,186
|
|
|
$
|
111,205
|
|
Revenues
|
For the years ended December 31,
|
|
|
||||||||
(In thousands)
|
2016
|
|
2015
|
|
Change
|
||||||
Revenue from services
|
$
|
1,012,129
|
|
|
$
|
329,739
|
|
|
$
|
682,390
|
|
Revenue from products
|
83,467
|
|
|
80,146
|
|
|
3,321
|
|
|||
Revenue from transfer of intellectual property and other
|
126,065
|
|
|
81,853
|
|
|
44,212
|
|
|||
Total revenues
|
$
|
1,221,661
|
|
|
$
|
491,738
|
|
|
$
|
729,923
|
|
Cost of Revenue
|
For the years ended December 31,
|
|
|
||||||||
(In thousands)
|
2016
|
|
2015
|
|
Change
|
||||||
Cost of service revenue
|
$
|
564,103
|
|
|
$
|
193,305
|
|
|
$
|
370,798
|
|
Cost of product revenue
|
47,379
|
|
|
41,934
|
|
|
5,445
|
|
|||
Total cost of revenue
|
$
|
611,482
|
|
|
$
|
235,239
|
|
|
$
|
376,243
|
|
|
For the years ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
External expenses:
|
|
|
|
||||
Phase 3 clinical trials
|
$
|
12,161
|
|
|
$
|
12,178
|
|
Manufacturing expense for biological products
|
35,985
|
|
|
31,202
|
|
||
Earlier-stage programs
|
6,297
|
|
|
6,900
|
|
||
Research and development employee-related expenses
|
28,676
|
|
|
27,363
|
|
||
Other internal research and development expenses
|
30,752
|
|
|
24,161
|
|
||
Third-party grants and funding from collaboration agreements
|
(2,666
|
)
|
|
(2,316
|
)
|
||
Total research and development expenses
|
$
|
111,205
|
|
|
$
|
99,488
|
|
Contractual obligations
(In thousands)
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
Thereafter
|
|
Total
|
||||||||||||||
Open purchase orders
|
|
$
|
80,810
|
|
|
$
|
1,312
|
|
|
$
|
38
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
82,160
|
|
Operating leases
|
|
19,059
|
|
|
15,166
|
|
|
9,360
|
|
|
6,079
|
|
|
3,148
|
|
|
3,542
|
|
|
56,354
|
|
|||||||
Capital leases
|
|
3,521
|
|
|
3,029
|
|
|
2,440
|
|
|
1,586
|
|
|
410
|
|
|
441
|
|
|
11,427
|
|
|||||||
2033 Senior Notes
|
|
—
|
|
|
31,850
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31,850
|
|
|||||||
Deferred payments
|
|
5,000
|
|
|
5,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,000
|
|
|||||||
Mortgages and other debts payable
|
|
1,632
|
|
|
415
|
|
|
415
|
|
|
415
|
|
|
415
|
|
|
351
|
|
|
3,643
|
|
|||||||
Lines of credit
|
|
10,511
|
|
|
—
|
|
|
104,152
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
114,663
|
|
|||||||
Severance payments
|
|
4,224
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,224
|
|
|||||||
Interest commitments
|
|
1,020
|
|
|
212
|
|
|
39
|
|
|
23
|
|
|
19
|
|
|
19
|
|
|
1,332
|
|
|||||||
Total
|
|
$
|
125,777
|
|
|
$
|
56,984
|
|
|
$
|
116,444
|
|
|
$
|
8,103
|
|
|
$
|
3,992
|
|
|
$
|
4,353
|
|
|
$
|
315,653
|
|
•
|
Unit of account – Most intangible assets are valued as single global assets rather than multiple assets for each jurisdiction or indication after considering the development stage, expected levels of incremental costs to obtain additional approvals, risks associated with further development, amount and timing of benefits expected to be derived in the future, expected patent lives in various jurisdictions and the intention to promote the asset as a global brand.
|
•
|
Estimated useful life – The asset life expected to contribute meaningful cash flows is determined after considering all pertinent matters associated with the asset, including expected regulatory approval dates (if unapproved), exclusivity periods and other legal, regulatory or contractual provisions as well as the effects of any obsolescence, demand, competition, and other economic factors, including barriers to entry.
|
•
|
Probability of Technical and Regulatory Success (“PTRS”) Rate – PTRS rates are determined based upon industry averages considering the respective program’s development stage and disease indication and adjusted for specific information or data known at the acquisition date. Subsequent clinical results or other internal or external data obtained could alter the PTRS rate and materially impact the estimated fair value of the intangible asset in subsequent periods leading to impairment charges.
|
•
|
Projections – Future revenues are estimated after considering many factors such as initial market opportunity, pricing, sales trajectories to peak sales levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical market trends, market participant synergies and the timing and level of additional development costs to obtain the initial or additional regulatory approvals, maintain or further enhance the product. We generally assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the project are likely to be different than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial success of the asset as well as significantly alter the costs to develop the respective asset into commercially viable products.
|
•
|
Tax rates – The expected future income is tax effected using a market participant tax rate. In determining the tax rate, we consider the jurisdiction in which the intellectual property is held and location of research and manufacturing infrastructure. We also consider that any repatriation of earnings would likely have U.S. tax consequences.
|
•
|
Discount rate – Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as expected changes in standards of practice for indications addressed by the asset.
|
(In thousands)
|
|
Chargebacks, discounts, rebates and fees
|
|
Governmental
|
|
Returns
|
|
Total
|
||||||||
Balance at December 31, 2016
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Provision related to current period sales
|
|
1,591
|
|
|
1,332
|
|
|
490
|
|
|
3,413
|
|
||||
Credits or payments made
|
|
(1,358
|
)
|
|
(984
|
)
|
|
(53
|
)
|
|
(2,395
|
)
|
||||
Balance at December 31, 2017
|
|
$
|
233
|
|
|
$
|
348
|
|
|
$
|
437
|
|
|
$
|
1,018
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total gross
Rayaldee
sales
|
|
|
|
|
|
|
|
$
|
12,482
|
|
||||||
Provision for
Rayaldee
sales allowances and accruals as a percentage of gross
Rayaldee
sales
|
|
|
|
|
|
|
|
27
|
%
|
|
Page
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
91,499
|
|
|
$
|
168,733
|
|
Accounts receivable, net
|
165,516
|
|
|
220,284
|
|
||
Inventory, net
|
49,333
|
|
|
47,228
|
|
||
Other current assets and prepaid expenses
|
37,113
|
|
|
47,356
|
|
||
Total current assets
|
343,461
|
|
|
483,601
|
|
||
Property, plant and equipment, net
|
146,557
|
|
|
122,831
|
|
||
Intangible assets, net
|
683,835
|
|
|
763,976
|
|
||
In-process research and development
|
647,347
|
|
|
644,713
|
|
||
Goodwill
|
717,099
|
|
|
704,603
|
|
||
Investments
|
40,642
|
|
|
41,139
|
|
||
Other assets
|
5,615
|
|
|
5,756
|
|
||
Total assets
|
$
|
2,584,556
|
|
|
$
|
2,766,619
|
|
LIABILITIES AND EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
74,307
|
|
|
$
|
53,360
|
|
Accrued expenses
|
215,102
|
|
|
197,955
|
|
||
Current portion of lines of credit and notes payable
|
11,926
|
|
|
11,981
|
|
||
Total current liabilities
|
301,335
|
|
|
263,296
|
|
||
2033 Senior Notes, net of discount
|
29,160
|
|
|
43,701
|
|
||
Deferred tax liabilities, net
|
148,729
|
|
|
165,331
|
|
||
Other long-term liabilities, principally deferred revenue, contingent consideration and lines of credit
|
219,954
|
|
|
202,483
|
|
||
Total long-term liabilities
|
397,843
|
|
|
411,515
|
|
||
Total liabilities
|
699,178
|
|
|
674,811
|
|
||
Equity:
|
|
|
|
||||
Common Stock - $0.01 par value, 750,000,000 shares authorized; 560,023,745 and 558,576,051
shares issued at December 31, 2017 and 2016, respectively |
5,600
|
|
|
5,586
|
|
||
Treasury Stock, at cost - 549,907 and 586,760 shares at December 31, 2017 and 2016,
respectively |
(1,791
|
)
|
|
(1,911
|
)
|
||
Additional paid-in capital
|
2,889,256
|
|
|
2,845,096
|
|
||
Accumulated other comprehensive income (loss)
|
(528
|
)
|
|
(27,009
|
)
|
||
Accumulated deficit
|
(1,007,159
|
)
|
|
(729,954
|
)
|
||
Total shareholders’ equity
|
1,885,378
|
|
|
2,091,808
|
|
||
Total liabilities and equity
|
$
|
2,584,556
|
|
|
$
|
2,766,619
|
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Revenue from services
|
$
|
889,076
|
|
|
$
|
1,012,129
|
|
|
$
|
329,739
|
|
Revenue from products
|
107,759
|
|
|
83,467
|
|
|
80,146
|
|
|||
Revenue from transfer of intellectual property and other
|
70,668
|
|
|
126,065
|
|
|
81,853
|
|
|||
Total revenues
|
1,067,503
|
|
|
1,221,661
|
|
|
491,738
|
|
|||
Costs and expenses:
|
|
|
|
|
|
||||||
Cost of service revenue
|
558,953
|
|
|
564,103
|
|
|
193,305
|
|
|||
Cost of product revenue
|
61,177
|
|
|
47,379
|
|
|
41,934
|
|
|||
Selling, general and administrative
|
520,994
|
|
|
490,888
|
|
|
196,576
|
|
|||
Research and development
|
125,186
|
|
|
111,205
|
|
|
99,488
|
|
|||
Contingent consideration
|
(3,423
|
)
|
|
16,954
|
|
|
5,050
|
|
|||
Amortization of intangible assets
|
84,678
|
|
|
64,407
|
|
|
27,977
|
|
|||
Grant repayment
|
—
|
|
|
—
|
|
|
25,889
|
|
|||
Total costs and expenses
|
1,347,565
|
|
|
1,294,936
|
|
|
590,219
|
|
|||
Operating loss
|
(280,062
|
)
|
|
(73,275
|
)
|
|
(98,481
|
)
|
|||
Other income and (expense), net:
|
|
|
|
|
|
||||||
Interest income
|
610
|
|
|
478
|
|
|
255
|
|
|||
Interest expense
|
(6,601
|
)
|
|
(7,430
|
)
|
|
(8,419
|
)
|
|||
Fair value changes of derivative instruments, net
|
52
|
|
|
2,778
|
|
|
(39,083
|
)
|
|||
Other income (expense), net
|
10,457
|
|
|
3,903
|
|
|
7,730
|
|
|||
Other income and (expense), net
|
4,518
|
|
|
(271
|
)
|
|
(39,517
|
)
|
|||
Loss before income taxes and investment losses
|
(275,544
|
)
|
|
(73,546
|
)
|
|
(137,998
|
)
|
|||
Income tax benefit (provision)
|
(18,855
|
)
|
|
56,115
|
|
|
113,675
|
|
|||
Net loss before investment losses
|
(294,399
|
)
|
|
(17,431
|
)
|
|
(24,323
|
)
|
|||
Loss from investments in investees
|
(14,471
|
)
|
|
(7,652
|
)
|
|
(7,105
|
)
|
|||
Net loss
|
(308,870
|
)
|
|
(25,083
|
)
|
|
(31,428
|
)
|
|||
Less: Net loss attributable to noncontrolling interests
|
—
|
|
|
—
|
|
|
(1,400
|
)
|
|||
Net loss attributable to common shareholders
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(30,028
|
)
|
Loss per share, basic and diluted:
|
|
|
|
|
|
||||||
Net loss per share
|
$
|
(0.55
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.06
|
)
|
Weighted average number of common shares
outstanding, basic and diluted
|
559,160,565
|
|
|
550,846,553
|
|
|
488,065,908
|
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net loss
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(31,428
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
||||||
Change in foreign currency translation and other comprehensive income (loss)
|
22,724
|
|
|
(4,955
|
)
|
|
(15,074
|
)
|
|||
Available for sale investments:
|
|
|
|
|
|
||||||
Change in unrealized gain (loss), net of tax
|
3,790
|
|
|
(3,810
|
)
|
|
(2,378
|
)
|
|||
Less: reclassification adjustments for losses included in net loss, net of tax
|
(33
|
)
|
|
4,293
|
|
|
7,307
|
|
|||
Comprehensive loss
|
(282,389
|
)
|
|
(29,555
|
)
|
|
(41,573
|
)
|
|||
Less: Comprehensive loss attributable to noncontrolling interest
|
—
|
|
|
—
|
|
|
(1,400
|
)
|
|||
Comprehensive loss attributable to common shareholders
|
$
|
(282,389
|
)
|
|
$
|
(29,555
|
)
|
|
$
|
(40,173
|
)
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In
Capital
|
|
Accumulated Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Noncontrolling
Interests
|
|
Total
|
||||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
|
|||||||||||||||||||||||
Balance at December 31, 2014
|
433,421,677
|
|
|
$
|
4,334
|
|
|
(1,245,367
|
)
|
|
$
|
(4,051
|
)
|
|
$
|
1,529,096
|
|
|
$
|
(12,392
|
)
|
|
$
|
(674,843
|
)
|
|
$
|
(6,403
|
)
|
|
$
|
835,741
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,074
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,074
|
|
|||||||
Exercise of Common Stock options and warrants
|
24,467,806
|
|
|
245
|
|
|
—
|
|
|
—
|
|
|
25,675
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
25,920
|
|
|||||||
Issuance of Common Stock for
EirGen purchase |
2,420,487
|
|
|
24
|
|
|
—
|
|
|
—
|
|
|
33,572
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
33,596
|
|
|||||||
Issuance of Common Stock for
BRL purchase |
76,566,147
|
|
|
766
|
|
|
—
|
|
|
—
|
|
|
949,244
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
950,010
|
|
|||||||
Issuance of Common Stock upon
exchange of 2033 Senior Notes |
8,118,062
|
|
|
81
|
|
|
—
|
|
|
—
|
|
|
120,218
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
120,299
|
|
|||||||
Issuance of Treasury Stock in
connection with OPKO Health Europe’s Contingent Consideration |
—
|
|
|
—
|
|
|
125,000
|
|
|
406
|
|
|
1,406
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,812
|
|
|||||||
Issuance of Common Stock for
OPKO Renal earnout |
1,194,337
|
|
|
12
|
|
|
—
|
|
|
—
|
|
|
20,100
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
20,112
|
|
|||||||
Net loss attributable to common
shareholders |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(30,028
|
)
|
|
—
|
|
|
(30,028
|
)
|
|||||||
Deconsolidation of SciVac
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,403
|
|
|
6,403
|
|
|||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,145
|
)
|
|
—
|
|
|
—
|
|
|
(10,145
|
)
|
|||||||
Balance at December 31, 2015
|
546,188,516
|
|
|
$
|
5,462
|
|
|
(1,120,367
|
)
|
|
$
|
(3,645
|
)
|
|
$
|
2,705,385
|
|
|
$
|
(22,537
|
)
|
|
$
|
(704,871
|
)
|
|
$
|
—
|
|
|
$
|
1,979,794
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In
Capital
|
|
Accumulated Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at December 31, 2015
|
546,188,516
|
|
|
$
|
5,462
|
|
|
(1,120,367
|
)
|
|
$
|
(3,645
|
)
|
|
$
|
2,705,385
|
|
|
$
|
(22,537
|
)
|
|
$
|
(704,871
|
)
|
|
$
|
1,979,794
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
42,693
|
|
|
—
|
|
|
—
|
|
|
42,693
|
|
||||||
Exercise of Common Stock options and warrants
|
3,292,753
|
|
|
33
|
|
|
—
|
|
|
—
|
|
|
8,575
|
|
|
—
|
|
|
—
|
|
|
8,608
|
|
||||||
Issuance of Common Stock upon
exchange of 2033 Senior Notes |
51,235
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
582
|
|
|
—
|
|
|
—
|
|
|
583
|
|
||||||
Issuance of Treasury Stock in
connection with OPKO Health Europe’s Contingent Consideration |
—
|
|
|
—
|
|
|
39,145
|
|
|
127
|
|
|
186
|
|
|
—
|
|
|
—
|
|
|
313
|
|
||||||
Issuance of Treasury Stock for investment in Xenetic
|
—
|
|
|
—
|
|
|
494,462
|
|
|
1,607
|
|
|
3,249
|
|
|
—
|
|
|
—
|
|
|
4,856
|
|
||||||
Issuance of Common Stock for
OPKO Renal earnout |
2,611,648
|
|
|
26
|
|
|
—
|
|
|
—
|
|
|
25,960
|
|
|
—
|
|
|
—
|
|
|
25,986
|
|
||||||
Issuance of Common Stock for
Transition Therapeutics purchase |
6,431,899
|
|
|
64
|
|
|
—
|
|
|
—
|
|
|
58,466
|
|
|
—
|
|
|
—
|
|
|
58,530
|
|
||||||
Net loss attributable to common
shareholders |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(25,083
|
)
|
|
(25,083
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,472
|
)
|
|
—
|
|
|
(4,472
|
)
|
||||||
Balance at December 31, 2016
|
558,576,051
|
|
|
$
|
5,586
|
|
|
(586,760
|
)
|
|
$
|
(1,911
|
)
|
|
$
|
2,845,096
|
|
|
$
|
(27,009
|
)
|
|
$
|
(729,954
|
)
|
|
$
|
2,091,808
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In
Capital
|
|
Accumulated Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at December 31, 2016
|
558,576,051
|
|
|
$
|
5,586
|
|
|
(586,760
|
)
|
|
$
|
(1,911
|
)
|
|
$
|
2,845,096
|
|
|
$
|
(27,009
|
)
|
|
$
|
(729,954
|
)
|
|
$
|
2,091,808
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28,307
|
|
|
—
|
|
|
—
|
|
|
28,307
|
|
||||||
Exercise of Common Stock options and warrants
|
1,447,694
|
|
|
14
|
|
|
—
|
|
|
—
|
|
|
2,118
|
|
|
—
|
|
|
—
|
|
|
2,132
|
|
||||||
Reclassification of embedded
derivatives to equity
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,551
|
|
|
—
|
|
|
—
|
|
|
13,551
|
|
||||||
Issuance of Treasury Stock in
connection with OPKO Health Europe’s Contingent Consideration |
—
|
|
|
—
|
|
|
36,853
|
|
|
120
|
|
|
184
|
|
|
—
|
|
|
—
|
|
|
304
|
|
||||||
Adoption of ASU 2016-09
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31,665
|
|
|
31,665
|
|
||||||
Net loss attributable to common
shareholders |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(308,870
|
)
|
|
(308,870
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,481
|
|
|
—
|
|
|
26,481
|
|
||||||
Balance at December 31, 2017
|
560,023,745
|
|
|
$
|
5,600
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
2,889,256
|
|
|
$
|
(528
|
)
|
|
$
|
(1,007,159
|
)
|
|
$
|
1,885,378
|
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(31,428
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
102,093
|
|
|
96,576
|
|
|
42,248
|
|
|||
Non-cash interest
|
2,575
|
|
|
2,699
|
|
|
2,612
|
|
|||
Amortization of deferred financing costs
|
224
|
|
|
237
|
|
|
1,212
|
|
|||
Losses from investments in investees
|
14,471
|
|
|
7,652
|
|
|
7,105
|
|
|||
Equity-based compensation – employees and non-employees
|
28,307
|
|
|
42,693
|
|
|
26,074
|
|
|||
Impairment of intangible assets
|
13,194
|
|
|
—
|
|
|
—
|
|
|||
Revenue from receipt of equity
|
—
|
|
|
—
|
|
|
(140
|
)
|
|||
Realized loss (gain) on equity securities and disposal of fixed assets
|
(8,663
|
)
|
|
2,321
|
|
|
7,091
|
|
|||
Loss (gain) on conversion of 3.00% convertible senior notes
|
—
|
|
|
284
|
|
|
(943
|
)
|
|||
Change in fair value of derivative instruments
|
(52
|
)
|
|
(2,778
|
)
|
|
39,083
|
|
|||
Change in fair value of contingent consideration
|
(3,423
|
)
|
|
16,954
|
|
|
5,050
|
|
|||
Gain on deconsolidation of SciVac
|
—
|
|
|
—
|
|
|
(15,940
|
)
|
|||
Deferred income tax provision (benefit)
|
16,092
|
|
|
(66,300
|
)
|
|
(123,536
|
)
|
|||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
|
|
||||||
Accounts receivable, net
|
58,011
|
|
|
(25,637
|
)
|
|
(4,845
|
)
|
|||
Inventory, net
|
(3,539
|
)
|
|
(6,607
|
)
|
|
(4,953
|
)
|
|||
Other current assets and prepaid expenses
|
10,171
|
|
|
17,262
|
|
|
(4,391
|
)
|
|||
Other assets
|
(2,372
|
)
|
|
(1,899
|
)
|
|
(305
|
)
|
|||
Accounts payable
|
20,171
|
|
|
(19,819
|
)
|
|
(18,122
|
)
|
|||
Foreign currency measurement
|
(255
|
)
|
|
(376
|
)
|
|
979
|
|
|||
Deferred revenue
|
(60,656
|
)
|
|
(74,169
|
)
|
|
227,671
|
|
|||
Accrued expenses and other liabilities
|
30,441
|
|
|
68,036
|
|
|
9,502
|
|
|||
Net cash provided by (used in) operating activities
|
(92,080
|
)
|
|
32,046
|
|
|
164,024
|
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Investments in investees
|
(9,625
|
)
|
|
(14,424
|
)
|
|
(4,375
|
)
|
|||
Proceeds from sale of equity securities
|
2,211
|
|
|
—
|
|
|
—
|
|
|||
Acquisition of businesses, net of cash acquired
|
—
|
|
|
15,878
|
|
|
(79,000
|
)
|
|||
Acquisition of intangible assets
|
—
|
|
|
(5,000
|
)
|
|
(5,000
|
)
|
|||
Purchase of marketable securities
|
—
|
|
|
(15,644
|
)
|
|
—
|
|
|||
Maturities of short-term marketable securities
|
—
|
|
|
15,634
|
|
|
—
|
|
|||
Proceeds from the sale of property, plant and equipment
|
7,271
|
|
|
1,401
|
|
|
—
|
|
|||
Capital expenditures
|
(46,524
|
)
|
|
(18,547
|
)
|
|
(10,846
|
)
|
|||
Net cash used in investing activities
|
(46,667
|
)
|
|
(20,702
|
)
|
|
(99,221
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Proceeds from the exercise of Common Stock options and warrants
|
2,132
|
|
|
8,576
|
|
|
25,921
|
|
|||
Cash from non-controlling interest
|
—
|
|
|
—
|
|
|
100
|
|
|||
Borrowings on lines of credit
|
92,421
|
|
|
22,407
|
|
|
261,339
|
|
|||
Repayments of lines of credit
|
(33,510
|
)
|
|
(66,178
|
)
|
|
(254,355
|
)
|
|||
Net cash provided by (used in) financing activities
|
61,043
|
|
|
(35,195
|
)
|
|
33,005
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
470
|
|
|
(1,014
|
)
|
|
(1,117
|
)
|
|||
Net (decrease) increase in cash and cash equivalents
|
(77,234
|
)
|
|
(24,865
|
)
|
|
96,691
|
|
|||
Cash and cash equivalents at beginning of period
|
168,733
|
|
|
193,598
|
|
|
96,907
|
|
|||
Cash and cash equivalents at end of period
|
$
|
91,499
|
|
|
$
|
168,733
|
|
|
$
|
193,598
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
|
|
||||||
Interest paid
|
$
|
1,313
|
|
|
$
|
2,890
|
|
|
$
|
4,572
|
|
Income taxes paid, net of refunds
|
$
|
5,416
|
|
|
$
|
(27,122
|
)
|
|
$
|
4,879
|
|
Non-cash financing:
|
|
|
|
|
|
||||||
Shares issued upon the conversion of:
|
|
|
|
|
|
||||||
2033 Senior Notes
|
$
|
—
|
|
|
$
|
583
|
|
|
$
|
120,299
|
|
Common Stock options and warrants, surrendered in net exercise
|
$
|
1,546
|
|
|
$
|
350
|
|
|
$
|
14,369
|
|
Issuance of capital stock to acquire or contingent consideration settlement:
|
|
|
|
|
|
||||||
Transition Therapeutics, Inc.
|
$
|
—
|
|
|
$
|
58,530
|
|
|
$
|
—
|
|
BioReference Laboratories, Inc.
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
950,148
|
|
EirGen Pharma Limited
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,569
|
|
OPKO Renal
|
$
|
—
|
|
|
$
|
25,986
|
|
|
$
|
20,113
|
|
OPKO Health Europe
|
$
|
303
|
|
|
$
|
313
|
|
|
$
|
1,813
|
|
Issuance of stock for investment in Xenetic
|
$
|
—
|
|
|
$
|
4,856
|
|
|
$
|
—
|
|
(In thousands)
|
|
Chargebacks, discounts, rebates and fees
|
|
Governmental
|
|
Returns
|
|
Total
|
||||||||
Balance at December 31, 2016
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Provision related to current period sales
|
|
1,591
|
|
|
1,332
|
|
|
490
|
|
|
3,413
|
|
||||
Credits or payments made
|
|
(1,358
|
)
|
|
(984
|
)
|
|
(53
|
)
|
|
(2,395
|
)
|
||||
Balance at December 31, 2017
|
|
$
|
233
|
|
|
$
|
348
|
|
|
$
|
437
|
|
|
$
|
1,018
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total gross
Rayaldee
sales
|
|
|
|
|
|
|
|
$
|
12,482
|
|
||||||
Provision for
Rayaldee
sales allowances and accruals as a percentage of gross
Rayaldee
sales
|
|
|
|
|
|
|
|
27
|
%
|
(In thousands)
|
|
Transition Therapeutics
|
||
Current assets
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
15,878
|
|
IPR&D assets
|
|
41,000
|
|
|
Goodwill
|
|
3,453
|
|
|
Other assets
|
|
634
|
|
|
Accounts payable and other liabilities
|
|
(1,035
|
)
|
|
Deferred tax liability
|
|
(1,400
|
)
|
|
Total purchase price
|
|
$
|
58,530
|
|
|
For the years ended December 31,
|
||||||
(In thousands)
|
2017
|
|
2016
|
||||
Accounts receivable, net
|
|
|
|
||||
Accounts receivable
|
$
|
231,940
|
|
|
$
|
256,552
|
|
Less: allowance for doubtful accounts
|
(66,424
|
)
|
|
(36,268
|
)
|
||
|
$
|
165,516
|
|
|
$
|
220,284
|
|
Inventories, net
|
|
|
|
||||
Consumable supplies
|
$
|
21,546
|
|
|
$
|
23,448
|
|
Finished products
|
21,012
|
|
|
16,143
|
|
||
Work in-process
|
5,873
|
|
|
3,896
|
|
||
Raw materials
|
7,467
|
|
|
4,686
|
|
||
Less: inventory reserve
|
(6,565
|
)
|
|
(945
|
)
|
||
|
$
|
49,333
|
|
|
$
|
47,228
|
|
Other current assets and prepaid expenses
|
|
|
|
||||
Other receivables
|
$
|
3,398
|
|
|
$
|
13,021
|
|
Taxes recoverable
|
18,138
|
|
|
16,187
|
|
||
Prepaid supplies
|
8,207
|
|
|
6,952
|
|
||
Prepaid insurance
|
3,532
|
|
|
3,688
|
|
||
Other
|
3,838
|
|
|
7,508
|
|
||
|
$
|
37,113
|
|
|
$
|
47,356
|
|
Property, plant and equipment, net:
|
|
|
|
||||
Machinery, medical and other equipment
|
$
|
112,961
|
|
|
$
|
100,100
|
|
Leasehold improvements
|
34,121
|
|
|
30,122
|
|
||
Furniture and fixtures
|
11,540
|
|
|
11,247
|
|
||
Automobiles and aircraft
|
11,137
|
|
|
13,342
|
|
||
Software
|
12,469
|
|
|
10,990
|
|
||
Building
|
8,227
|
|
|
5,696
|
|
||
Land
|
2,552
|
|
|
2,264
|
|
||
Construction in process
|
39,397
|
|
|
5,848
|
|
||
Less: accumulated depreciation
|
(85,847
|
)
|
|
(56,778
|
)
|
||
|
$
|
146,557
|
|
|
$
|
122,831
|
|
Intangible assets, net:
|
|
|
|
||||
Customer relationships
|
$
|
448,345
|
|
|
$
|
443,560
|
|
Technologies
|
340,921
|
|
|
340,397
|
|
||
Trade names
|
50,553
|
|
|
50,442
|
|
||
Covenants not to compete
|
16,372
|
|
|
16,348
|
|
||
Licenses
|
10,305
|
|
|
23,506
|
|
||
Product registrations
|
10,475
|
|
|
7,641
|
|
||
Other
|
5,799
|
|
|
5,289
|
|
||
Less: accumulated amortization
|
(198,935
|
)
|
|
(123,207
|
)
|
||
|
$
|
683,835
|
|
|
$
|
763,976
|
|
Accrued expenses:
|
|
|
|
||||
Deferred revenue
|
$
|
46,189
|
|
|
$
|
73,434
|
|
Employee benefits
|
50,377
|
|
|
43,792
|
|
||
Taxes payable
|
4,609
|
|
|
4,430
|
|
||
Contingent consideration
|
11,750
|
|
|
259
|
|
|
For the years ended December 31,
|
||||||
(In thousands)
|
2017
|
|
2016
|
||||
Clinical trials
|
12,191
|
|
|
5,935
|
|
||
Capital leases short-term
|
3,399
|
|
|
3,025
|
|
||
Milestone payment
|
4,868
|
|
|
4,865
|
|
||
Professional fees
|
2,355
|
|
|
4,035
|
|
||
Other
|
79,364
|
|
|
58,180
|
|
||
|
$
|
215,102
|
|
|
$
|
197,955
|
|
|
|
|
|
||||
Other long-term liabilities:
|
|
|
|
||||
Deferred revenue
|
$
|
58,989
|
|
|
$
|
89,016
|
|
Line of credit
|
104,152
|
|
|
38,809
|
|
||
Contingent consideration
|
29,603
|
|
|
44,817
|
|
||
Capital leases long-term
|
7,786
|
|
|
7,216
|
|
||
Mortgages and other debts payable
|
1,567
|
|
|
717
|
|
||
Other
|
17,857
|
|
|
21,908
|
|
||
|
$
|
219,954
|
|
|
$
|
202,483
|
|
(In thousands)
|
Technologies
|
|
In-process research and development
|
|
Customer relationships
|
|
Product registrations
|
|
Covenants not to compete
|
|
Trade names
|
|
Other
|
|
Total identified intangible assets
|
|
Goodwill
|
||||||||||||||||||
BioReference
|
$
|
100,600
|
|
|
$
|
—
|
|
|
$
|
389,800
|
|
|
$
|
—
|
|
|
$
|
7,750
|
|
|
$
|
47,100
|
|
|
$
|
—
|
|
|
$
|
545,250
|
|
|
$
|
401,821
|
|
CURNA
|
—
|
|
|
10,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
290
|
|
|
10,290
|
|
|
4,827
|
|
|||||||||
EirGen
|
—
|
|
|
560
|
|
|
34,155
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,919
|
|
|
38,634
|
|
|
83,373
|
|
|||||||||
FineTech
|
2,700
|
|
|
—
|
|
|
14,200
|
|
|
—
|
|
|
1,500
|
|
|
400
|
|
|
—
|
|
|
18,800
|
|
|
11,623
|
|
|||||||||
OPKO Biologics
|
—
|
|
|
590,200
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
590,200
|
|
|
139,784
|
|
|||||||||
OPKO
Chile
|
—
|
|
|
—
|
|
|
3,945
|
|
|
5,829
|
|
|
—
|
|
|
1,032
|
|
|
—
|
|
|
10,806
|
|
|
5,441
|
|
|||||||||
OPKO Diagnostics
|
44,400
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
44,400
|
|
|
17,977
|
|
|||||||||
OPKO Health Europe
|
3,017
|
|
|
1,459
|
|
|
436
|
|
|
2,930
|
|
|
187
|
|
|
349
|
|
|
—
|
|
|
8,378
|
|
|
8,062
|
|
|||||||||
OPKO Lab
|
1,370
|
|
|
—
|
|
|
3,860
|
|
|
—
|
|
|
6,900
|
|
|
1,830
|
|
|
70
|
|
|
14,030
|
|
|
29,629
|
|
|||||||||
OPKO Renal
|
—
|
|
|
191,530
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
210
|
|
|
191,740
|
|
|
2,411
|
|
|||||||||
Transition Therapeutics
|
—
|
|
|
41,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
41,000
|
|
|
3,453
|
|
|||||||||
Weighted average amortization period
|
8-12 years
|
|
|
Indefinite
|
|
|
6-20 years
|
|
|
9 years
|
|
|
5 years
|
|
|
4-5 years
|
|
|
3-10 years
|
|
|
|
|
Indefinite
|
|
(In thousands)
|
Beginning
balance
|
|
Charged
to
expense
|
|
Written-off
|
|
Charged
to other
|
|
Ending
balance
|
|||||||
2017
|
|
|
|
|
|
|
|
|
|
|||||||
Allowance for doubtful accounts
|
$
|
(36,268
|
)
|
|
(107,256
|
)
|
|
77,047
|
|
|
53
|
|
|
$
|
(66,424
|
)
|
Inventory reserve
|
$
|
(945
|
)
|
|
(5,390
|
)
|
|
(230
|
)
|
|
—
|
|
|
$
|
(6,565
|
)
|
Tax valuation allowance
|
$
|
(55,415
|
)
|
|
(82,358
|
)
|
|
—
|
|
|
(4,289
|
)
|
|
$
|
(142,062
|
)
|
2016
|
|
|
|
|
|
|
|
|
|
|||||||
Allowance for doubtful accounts
|
$
|
(25,168
|
)
|
|
(83,463
|
)
|
|
68,840
|
|
|
3,523
|
|
|
$
|
(36,268
|
)
|
Inventory reserve
|
$
|
(1,051
|
)
|
|
(20
|
)
|
|
296
|
|
|
(170
|
)
|
|
$
|
(945
|
)
|
Tax valuation allowance
|
$
|
(42,147
|
)
|
|
7,726
|
|
|
—
|
|
|
(20,994
|
)
|
|
$
|
(55,415
|
)
|
|
2017
|
|
2016
|
||||||||||||||||||||||||||||
(In thousands)
|
Balance at January 1
|
|
Purchase Accounting Adj
|
|
Foreign exchange and other
|
|
Balance at December 31st
|
|
Balance at January 1
|
|
Purchase accounting adjustments
|
|
Foreign exchange
|
|
Balance at December 31
|
||||||||||||||||
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
CURNA
|
$
|
4,827
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,827
|
|
|
$
|
4,827
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,827
|
|
EirGen
|
78,358
|
|
|
—
|
|
|
10,868
|
|
|
89,226
|
|
|
81,139
|
|
|
—
|
|
|
(2,781
|
)
|
|
78,358
|
|
||||||||
FineTech
|
11,698
|
|
|
—
|
|
|
—
|
|
|
11,698
|
|
|
11,698
|
|
|
—
|
|
|
—
|
|
|
11,698
|
|
||||||||
OPKO Biologics
|
139,784
|
|
|
—
|
|
|
—
|
|
|
139,784
|
|
|
139,784
|
|
|
—
|
|
|
—
|
|
|
139,784
|
|
||||||||
OPKO Chile
|
4,785
|
|
|
—
|
|
|
418
|
|
|
5,203
|
|
|
4,517
|
|
|
—
|
|
|
268
|
|
|
4,785
|
|
||||||||
OPKO Health Europe
|
6,936
|
|
|
—
|
|
|
962
|
|
|
7,898
|
|
|
7,191
|
|
|
—
|
|
|
(255
|
)
|
|
6,936
|
|
||||||||
OPKO Renal
|
2,069
|
|
|
—
|
|
|
—
|
|
|
2,069
|
|
|
2,069
|
|
|
—
|
|
|
—
|
|
|
2,069
|
|
||||||||
Transition Therapeutics
|
3,360
|
|
|
—
|
|
|
248
|
|
|
3,608
|
|
|
—
|
|
|
3,453
|
|
|
(93
|
)
|
|
3,360
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Diagnostics
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
BioReference
|
401,821
|
|
|
—
|
|
|
—
|
|
|
401,821
|
|
|
441,158
|
|
|
(39,337
|
)
|
|
—
|
|
|
401,821
|
|
||||||||
OPKO Diagnostics
|
17,977
|
|
|
—
|
|
|
—
|
|
|
17,977
|
|
|
17,977
|
|
|
—
|
|
|
—
|
|
|
17,977
|
|
||||||||
OPKO Lab
|
32,988
|
|
|
—
|
|
|
—
|
|
|
32,988
|
|
|
32,988
|
|
|
—
|
|
|
—
|
|
|
32,988
|
|
||||||||
|
$
|
704,603
|
|
|
$
|
—
|
|
|
$
|
12,496
|
|
|
$
|
717,099
|
|
|
$
|
743,348
|
|
|
$
|
(35,884
|
)
|
|
$
|
(2,861
|
)
|
|
$
|
704,603
|
|
(In thousands)
|
Embedded conversion option
|
|
2033 Senior Notes
|
|
Discount
|
|
Debt Issuance Cost
|
|
Total
|
||||||||||
Balance at December 31, 2016
|
$
|
16,736
|
|
|
$
|
31,850
|
|
|
$
|
(4,612
|
)
|
|
$
|
(273
|
)
|
|
$
|
43,701
|
|
Amortization of debt discount and debt issuance costs
|
—
|
|
|
—
|
|
|
2,047
|
|
|
148
|
|
|
2,195
|
|
|||||
Change in fair value of embedded derivative
|
(3,185
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,185
|
)
|
|||||
Reclassification of embedded derivatives to equity
|
(13,551
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,551
|
)
|
|||||
Balance at December 31, 2017
|
$
|
—
|
|
|
$
|
31,850
|
|
|
$
|
(2,565
|
)
|
|
$
|
(125
|
)
|
|
$
|
29,160
|
|
(In thousands)
|
Embedded conversion option
|
|
2033 Senior Notes
|
|
Discount
|
|
Debt Issuance Cost
|
|
Total
|
||||||||||
Balance at December 31, 2015
|
$
|
23,737
|
|
|
$
|
32,200
|
|
|
$
|
(6,525
|
)
|
|
$
|
(426
|
)
|
|
$
|
48,986
|
|
Amortization of debt discount and debt issuance costs
|
—
|
|
|
—
|
|
|
1,913
|
|
|
153
|
|
|
2,066
|
|
|||||
Change in fair value of embedded derivative
|
(7,001
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,001
|
)
|
|||||
Conversion
|
—
|
|
|
(350
|
)
|
|
—
|
|
|
—
|
|
|
(350
|
)
|
|||||
Balance at December 31, 2016
|
$
|
16,736
|
|
|
$
|
31,850
|
|
|
$
|
(4,612
|
)
|
|
$
|
(273
|
)
|
|
$
|
43,701
|
|
|
February 1, 2017
|
|
December 31, 2016
|
|
December 31, 2015
|
Stock price
|
$8.63
|
|
$9.30
|
|
$10.05
|
Conversion Rate
|
141.4827
|
|
141.4827
|
|
141.4827
|
Conversion Price
|
$7.07
|
|
$7.07
|
|
$7.07
|
Maturity date
|
February 1, 2033
|
|
February 1, 2033
|
|
February 1, 2033
|
Risk-free interest rate
|
1.22%
|
|
1.22%
|
|
1.33%
|
Estimated stock volatility
|
49%
|
|
47%
|
|
50%
|
Estimated credit spread
|
761 basis points
|
|
765 basis points
|
|
1,142 basis points
|
(Dollars in thousands)
|
|
|
|
|
|
Balance Outstanding
|
||||||||
Lender
|
|
Interest rate on
borrowings at December 31, 2017
|
|
Credit line
capacity
|
|
December 31,
2017 |
|
December 31,
2016
|
||||||
JP Morgan Chase
|
|
3.27%
|
|
$
|
175,000
|
|
|
$
|
104,152
|
|
|
$
|
38,809
|
|
Itau Bank
|
|
5.50%
|
|
1,810
|
|
|
446
|
|
|
419
|
|
|||
Bank of Chile
|
|
6.60%
|
|
3,800
|
|
|
1,598
|
|
|
1,619
|
|
|||
BICE Bank
|
|
5.50%
|
|
2,500
|
|
|
1,819
|
|
|
1,538
|
|
|||
BBVA Bank
|
|
5.50%
|
|
3,250
|
|
|
1,665
|
|
|
1,063
|
|
|||
Security Bank
|
|
5.50%
|
|
501
|
|
|
501
|
|
|
—
|
|
|||
Estado Bank
|
|
5.50%
|
|
3,500
|
|
|
2,111
|
|
|
1,870
|
|
|||
Santander Bank
|
|
5.50%
|
|
4,500
|
|
|
1,988
|
|
|
1,196
|
|
|||
Scotiabank
|
|
5.00%
|
|
1,800
|
|
|
384
|
|
|
789
|
|
|||
Corpbanca
|
|
5.00%
|
|
—
|
|
|
—
|
|
|
18
|
|
|||
Banco Bilbao Vizcaya
|
|
2.90%
|
|
300
|
|
|
—
|
|
|
—
|
|
|||
Santander Bank
|
|
2.67%
|
|
359
|
|
|
—
|
|
|
—
|
|
|||
Total
|
|
|
|
$
|
197,320
|
|
|
$
|
114,664
|
|
|
$
|
47,321
|
|
(In thousands)
|
December 31,
2017 |
|
December 31,
2016
|
||||
Current portion of notes payable
|
$
|
1,632
|
|
|
$
|
3,681
|
|
Other long-term liabilities
|
2,011
|
|
|
2,090
|
|
||
Total
|
$
|
3,643
|
|
|
$
|
5,771
|
|
|
Number of
warrants
|
|
Weighted
average
exercise price
|
|
Expiration date
|
|||
Outstanding at December 31, 2016
|
639,598
|
|
|
$
|
0.86
|
|
|
Various from
January 2017 through March 2017 |
Exercised
|
(416,295
|
)
|
|
0.86
|
|
|
|
|
Expired
|
(223,303
|
)
|
|
0.86
|
|
|
|
|
Outstanding and Exercisable at December 31, 2017
|
—
|
|
|
$
|
—
|
|
|
|
(In thousands)
|
Foreign
currency translation |
|
Unrealized
gain (loss) in
Accumulated
OCI
|
|
Total
|
||||||
Balance at December 31, 2016
|
$
|
(28,128
|
)
|
|
$
|
1,119
|
|
|
$
|
(27,009
|
)
|
Other comprehensive income (loss) before reclassifications
|
22,724
|
|
|
3,790
|
|
|
26,514
|
|
|||
Reclassification adjustments for losses included in net loss, net of tax
|
—
|
|
|
(33
|
)
|
|
(33
|
)
|
|||
Net other comprehensive income (loss)
|
22,724
|
|
|
3,757
|
|
|
26,481
|
|
|||
Balance at December 31, 2017
|
$
|
(5,404
|
)
|
|
$
|
4,876
|
|
|
$
|
(528
|
)
|
(In thousands)
|
Foreign
currency translation |
|
Unrealized
gain (loss) in Accumulated OCI |
|
Total
|
||||||
Balance at December 31, 2015
|
$
|
(23,174
|
)
|
|
$
|
637
|
|
|
$
|
(22,537
|
)
|
Other comprehensive income (loss) before reclassifications
|
(4,954
|
)
|
|
(3,811
|
)
|
|
(8,765
|
)
|
|||
Reclassification adjustments for losses included in net loss, net of tax
|
—
|
|
|
4,293
|
|
|
4,293
|
|
|||
Net other comprehensive income (loss)
|
(4,954
|
)
|
|
482
|
|
|
(4,472
|
)
|
|||
Balance at December 31, 2016
|
$
|
(28,128
|
)
|
|
$
|
1,119
|
|
|
$
|
(27,009
|
)
|
|
Year Ended
December 31,
2017
|
|
Year Ended
December 31,
2016
|
|
Year Ended
December 31,
2015
|
Expected term (in years)
|
3.0 - 10.0
|
|
1.0 - 10.0
|
|
1.0 - 10.0
|
Risk-free interest rate
|
1.32% - 2.41%
|
|
0.71% - 2.51%
|
|
0.26% - 2.42%
|
Expected volatility
|
38% - 55%
|
|
38% - 64%
|
|
32% - 64%
|
Expected dividend yield
|
0%
|
|
0%
|
|
0%
|
Options
|
Number of
options
|
|
Weighted
average
exercise
price
|
|
Weighted
average
remaining
contractual
term (years)
|
|
Aggregate
intrinsic value
(in thousands)
|
|||||
Outstanding at December 31, 2016
|
34,640,514
|
|
|
$
|
10.18
|
|
|
6.79
|
|
$
|
32,984
|
|
Granted
|
2,131,500
|
|
|
$
|
7.50
|
|
|
|
|
|
||
Exercised
|
(1,298,704
|
)
|
|
$
|
3.01
|
|
|
|
|
|
||
Forfeited
|
(2,735,813
|
)
|
|
$
|
11.75
|
|
|
|
|
|
||
Expired
|
(1,438,112
|
)
|
|
$
|
11.84
|
|
|
|
|
|
||
Outstanding at December 31, 2017
|
31,299,385
|
|
|
$
|
10.08
|
|
|
6.37
|
|
$
|
1,886
|
|
Vested and expected to vest at December 31, 2017
|
29,484,888
|
|
|
$
|
10.04
|
|
|
6.27
|
|
$
|
1,886
|
|
Exercisable at December 31, 2017
|
18,697,466
|
|
|
$
|
9.59
|
|
|
5.26
|
|
$
|
1,886
|
|
|
For the years ended December 31,
|
||||||||||
(In thousands)
|
2017
|
|
2016
|
|
2015
|
||||||
Current
|
|
|
|
|
|
||||||
Federal
|
$
|
2,398
|
|
|
$
|
—
|
|
|
$
|
430
|
|
State
|
(1,737
|
)
|
|
(2,931
|
)
|
|
(2,157
|
)
|
|||
Foreign
|
(3,424
|
)
|
|
(2,438
|
)
|
|
(8,134
|
)
|
|||
|
(2,763
|
)
|
|
(5,369
|
)
|
|
(9,861
|
)
|
|||
Deferred
|
|
|
|
|
|
||||||
Federal
|
(10,759
|
)
|
|
25,739
|
|
|
109,286
|
|
|||
State
|
(2,738
|
)
|
|
10,657
|
|
|
12,327
|
|
|||
Foreign
|
(2,595
|
)
|
|
25,088
|
|
|
1,923
|
|
|||
|
(16,092
|
)
|
|
61,484
|
|
|
123,536
|
|
|||
Total, net
|
$
|
(18,855
|
)
|
|
$
|
56,115
|
|
|
$
|
113,675
|
|
(In thousands)
|
December 31, 2017
|
|
December 31, 2016
|
||||
Deferred income tax assets:
|
|
|
|
||||
Federal net operating loss
|
$
|
79,356
|
|
|
$
|
76,792
|
|
State net operating loss
|
46,571
|
|
|
36,285
|
|
||
Foreign net operating loss
|
35,710
|
|
|
32,895
|
|
||
Research and development expense
|
4,038
|
|
|
3,246
|
|
||
Tax credits
|
20,040
|
|
|
20,894
|
|
||
Stock options
|
28,830
|
|
|
36,485
|
|
||
Accruals
|
5,719
|
|
|
8,306
|
|
||
Equity investments
|
8,454
|
|
|
7,011
|
|
||
Bad debts
|
20,302
|
|
|
14,283
|
|
||
Lease liability
|
2,205
|
|
|
3,233
|
|
||
Foreign credits
|
11,113
|
|
|
10,253
|
|
||
Available for sale securities
|
2,406
|
|
|
4,792
|
|
||
Other
|
17,448
|
|
|
7,795
|
|
||
Deferred income tax assets
|
282,192
|
|
|
262,270
|
|
||
Deferred income tax liabilities:
|
|
|
|
||||
Intangible assets
|
(280,962
|
)
|
|
(354,043
|
)
|
||
Fixed assets
|
(5,572
|
)
|
|
(13,710
|
)
|
||
Other
|
(2,325
|
)
|
|
(2,121
|
)
|
||
Deferred income tax liabilities
|
(288,859
|
)
|
|
(369,874
|
)
|
||
Net deferred income tax liabilities
|
(6,667
|
)
|
|
(107,604
|
)
|
||
Valuation allowance
|
(142,062
|
)
|
|
(55,415
|
)
|
||
Net deferred income tax liabilities
|
$
|
(148,729
|
)
|
|
$
|
(163,019
|
)
|
|
For the years ended December 31,
|
||||||||||
(In thousands)
|
2017
|
|
2016
|
|
2015
|
||||||
Unrecognized tax benefits at beginning of period
|
$
|
27,545
|
|
|
$
|
8,595
|
|
|
$
|
5,890
|
|
Gross increases – tax positions in prior period
|
44
|
|
|
1,443
|
|
|
955
|
|
|||
Gross increases – tax positions in current period
|
—
|
|
|
18,472
|
|
|
2,543
|
|
|||
Gross decreases – tax positions in prior period
|
(1,724
|
)
|
|
(671
|
)
|
|
(176
|
)
|
|||
Lapse of Statute of Limitations
|
(4,518
|
)
|
|
(294
|
)
|
|
(617
|
)
|
|||
Unrecognized tax benefits at end of period
|
$
|
21,347
|
|
|
$
|
27,545
|
|
|
$
|
8,595
|
|
|
For the years ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Federal statutory rate
|
35.0
|
%
|
|
35.0
|
%
|
|
35.0
|
%
|
State income taxes, net of federal benefit
|
5.1
|
%
|
|
5.2
|
%
|
|
2.8
|
%
|
Foreign income tax
|
(5.2
|
)%
|
|
1.2
|
%
|
|
(7.8
|
)%
|
Research and development tax credits
|
0.6
|
%
|
|
5.4
|
%
|
|
—
|
%
|
Non-Deductible components of Convertible Debt
|
0.1
|
%
|
|
2.2
|
%
|
|
(9.4
|
)%
|
Valuation allowance
|
(28.4
|
)%
|
|
9.5
|
%
|
|
61.1
|
%
|
Rate change effect
|
(10.8
|
)%
|
|
21.2
|
%
|
|
—
|
%
|
Non-deductible items
|
(1.9
|
)%
|
|
(1.9
|
)%
|
|
(0.7
|
)%
|
Other
|
(1.0
|
)%
|
|
(8.7
|
)%
|
|
(1.0
|
)%
|
Total
|
(6.5
|
)%
|
|
69.1
|
%
|
|
80.0
|
%
|
|
For the years ended December 31,
|
||||||||||
(In thousands)
|
2017
|
|
2016
|
|
2015
|
||||||
Pre-tax income (loss):
|
|
|
|
|
|
||||||
U.S.
|
$
|
(247,938
|
)
|
|
$
|
(92,175
|
)
|
|
$
|
(113,612
|
)
|
Foreign
|
(42,077
|
)
|
|
10,977
|
|
|
(30,091
|
)
|
|||
Total
|
$
|
(290,015
|
)
|
|
$
|
(81,198
|
)
|
|
$
|
(143,703
|
)
|
Year Ending
|
(In thousands)
|
||
2018
|
$
|
19,059
|
|
2019
|
15,166
|
|
|
2020
|
9,360
|
|
|
2021
|
6,079
|
|
|
2022
|
3,148
|
|
|
Thereafter
|
3,542
|
|
|
Total minimum operating lease commitments
|
$
|
56,354
|
|
Capital leases
|
Year ended December 31, 2017
|
||
Automobiles
|
$
|
11,137
|
|
Less: Accumulated Depreciation
|
(4,366
|
)
|
|
Net capital leases in Property, plant and equipment
|
$
|
6,771
|
|
Year Ending
|
(In thousands)
|
||
2018
|
$
|
3,521
|
|
2019
|
3,029
|
|
|
2020
|
2,440
|
|
|
2021
|
1,586
|
|
|
2022
|
410
|
|
|
Thereafter
|
441
|
|
|
Total minimum capital lease commitments
|
11,427
|
|
|
Less: Amounts representing interest
|
242
|
|
|
Net capital liability
|
$
|
11,185
|
|
|
|
||
Current
|
$
|
3,399
|
|
Long-term
|
$
|
7,786
|
|
|
For the years ended December 31,
|
||||||||||
(In thousands)
|
2017
|
|
2016
|
|
2015
|
||||||
Revenue from services:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Diagnostics
|
889,076
|
|
|
1,012,129
|
|
|
329,599
|
|
|||
Corporate
|
—
|
|
|
—
|
|
|
140
|
|
|||
|
$
|
889,076
|
|
|
$
|
1,012,129
|
|
|
$
|
329,739
|
|
Revenue from products:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
107,759
|
|
|
$
|
83,467
|
|
|
$
|
80,146
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
$
|
107,759
|
|
|
$
|
83,467
|
|
|
$
|
80,146
|
|
Revenue from transfer of intellectual property:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
70,668
|
|
|
$
|
126,065
|
|
|
$
|
81,853
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
$
|
70,668
|
|
|
$
|
126,065
|
|
|
$
|
81,853
|
|
Operating loss:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
(87,907
|
)
|
|
$
|
(9,841
|
)
|
|
$
|
(40,395
|
)
|
Diagnostics
|
(136,540
|
)
|
|
(3,393
|
)
|
|
(10,294
|
)
|
|||
Corporate
|
(55,615
|
)
|
|
(60,041
|
)
|
|
(46,512
|
)
|
|||
Less: Operating loss attributable to noncontrolling interests
|
—
|
|
|
—
|
|
|
(1,280
|
)
|
|||
|
$
|
(280,062
|
)
|
|
$
|
(73,275
|
)
|
|
$
|
(98,481
|
)
|
Depreciation and amortization:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
27,513
|
|
|
$
|
18,254
|
|
|
$
|
10,245
|
|
Diagnostics
|
74,442
|
|
|
78,233
|
|
|
31,918
|
|
|||
Corporate
|
138
|
|
|
89
|
|
|
85
|
|
|||
|
$
|
102,093
|
|
|
$
|
96,576
|
|
|
$
|
42,248
|
|
Income (loss) from investment in investees:
|
|
|
|
|
|
||||||
Pharmaceutical
|
$
|
(12,646
|
)
|
|
$
|
(7,665
|
)
|
|
$
|
(7,105
|
)
|
Diagnostics
|
(1,825
|
)
|
|
13
|
|
|
—
|
|
|||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
$
|
(14,471
|
)
|
|
$
|
(7,652
|
)
|
|
$
|
(7,105
|
)
|
Revenues:
|
|
|
|
|
|
||||||
United States
|
$
|
908,971
|
|
|
$
|
1,014,389
|
|
|
$
|
344,464
|
|
Ireland
|
77,285
|
|
|
137,785
|
|
|
78,989
|
|
|||
Chile
|
44,286
|
|
|
35,364
|
|
|
29,885
|
|
|||
Spain
|
18,285
|
|
|
15,812
|
|
|
16,622
|
|
|||
Israel
|
13,951
|
|
|
15,317
|
|
|
18,107
|
|
|||
Mexico
|
4,605
|
|
|
2,988
|
|
|
3,671
|
|
|||
Other
|
120
|
|
|
6
|
|
|
—
|
|
|||
|
$
|
1,067,503
|
|
|
$
|
1,221,661
|
|
|
$
|
491,738
|
|
(In thousands)
|
December 31,
2017 |
|
December 31,
2016 |
||||
Assets:
|
|
|
|
||||
Pharmaceutical
|
$
|
1,282,564
|
|
|
$
|
1,294,916
|
|
Diagnostics
|
1,241,388
|
|
|
1,408,522
|
|
||
Corporate
|
60,604
|
|
|
63,181
|
|
||
|
$
|
2,584,556
|
|
|
$
|
2,766,619
|
|
Goodwill:
|
|
|
|
||||
Pharmaceutical
|
$
|
264,313
|
|
|
$
|
251,817
|
|
Diagnostics
|
452,786
|
|
|
452,786
|
|
||
Corporate
|
—
|
|
|
—
|
|
||
|
$
|
717,099
|
|
|
$
|
704,603
|
|
(In thousands)
|
December 31, 2017
|
|
December 31, 2016
|
||||
PP&E:
|
|
|
|
||||
U.S.
|
$
|
89,114
|
|
|
$
|
100,716
|
|
Foreign
|
57,443
|
|
|
22,115
|
|
||
Total
|
$
|
146,557
|
|
|
$
|
122,831
|
|
|
As of December 31, 2017
|
||||||||||||||
(In thousands)
|
Amortized
Cost
|
|
Gross
unrealized
gains in
Accumulated
OCI
|
|
Gross
unrealized
losses in
Accumulated
OCI
|
|
Fair
value
|
||||||||
Common stock investments, available for sale
|
$
|
7,585
|
|
|
$
|
5,075
|
|
|
$
|
(199
|
)
|
|
$
|
12,461
|
|
|
As of December 31, 2016
|
||||||||||||||
(In thousands)
|
Amortized
Cost
|
|
Gross
unrealized
gains in
Accumulated
OCI
|
|
Gross
unrealized
losses in
Accumulated
OCI
|
|
Fair
value
|
||||||||
Common stock investments, available for sale
|
$
|
3,409
|
|
|
$
|
1,313
|
|
|
$
|
(194
|
)
|
|
$
|
4,528
|
|
|
Fair value measurements as of December 31, 2017
|
||||||||||||||
(In thousands)
|
Quoted
prices in
active
markets for
identical
assets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
107
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
107
|
|
Common stock investments, available for sale
|
12,461
|
|
|
—
|
|
|
—
|
|
|
12,461
|
|
||||
Common stock options/warrants
|
—
|
|
|
3,333
|
|
|
—
|
|
|
3,333
|
|
||||
Total assets
|
$
|
12,568
|
|
|
$
|
3,333
|
|
|
$
|
—
|
|
|
$
|
15,901
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Forward Contracts
|
—
|
|
|
317
|
|
|
—
|
|
|
317
|
|
||||
Contingent consideration:
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
41,353
|
|
|
41,353
|
|
|
Total liabilities
|
$
|
—
|
|
|
$
|
317
|
|
|
$
|
41,353
|
|
|
$
|
41,670
|
|
|
Fair value measurements as of December 31, 2016
|
||||||||||||||
(In thousands)
|
Quoted
prices in
active
markets for
identical
assets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
5,314
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,314
|
|
Common stock investments, available for sale
|
4,528
|
|
|
—
|
|
|
—
|
|
|
4,528
|
|
||||
Common stock options/warrants
|
—
|
|
|
4,017
|
|
|
—
|
|
|
4,017
|
|
||||
Forward contracts
|
—
|
|
|
39
|
|
|
—
|
|
|
39
|
|
||||
Total assets
|
$
|
9,842
|
|
|
$
|
4,056
|
|
|
$
|
—
|
|
|
$
|
13,898
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded conversion option
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,736
|
|
|
$
|
16,736
|
|
Contingent consideration:
|
—
|
|
|
—
|
|
|
45,076
|
|
|
45,076
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
61,812
|
|
|
$
|
61,812
|
|
|
December 31, 2017
|
||||||||||||||||||
(In thousands)
|
Carrying
Value
|
|
Total
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||
2033 Senior Notes
|
$
|
29,160
|
|
|
$
|
32,968
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,968
|
|
|
December 31, 2016
|
||||||||||||||||||
(In thousands)
|
Carrying
Value
|
|
Total
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||
2033 Senior Notes
|
$
|
26,965
|
|
|
$
|
45,205
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,205
|
|
|
December 31, 2017
|
||||||
(In thousands)
|
Contingent
consideration
|
|
Embedded
conversion
option
|
||||
Balance at December 31, 2016
|
$
|
45,076
|
|
|
$
|
16,736
|
|
Total losses (gains) for the period:
|
|
|
|
||||
Included in results of operations
|
(3,423
|
)
|
|
(3,185
|
)
|
||
Foreign currency impact
|
3
|
|
|
—
|
|
||
Payments
|
(303
|
)
|
|
—
|
|
||
Reclassification of embedded derivatives to equity
|
—
|
|
|
(13,551
|
)
|
||
Balance at December 31, 2017
|
$
|
41,353
|
|
|
$
|
—
|
|
|
December 31, 2016
|
||||||
(In thousands)
|
Contingent
consideration |
|
Embedded
conversion option |
||||
Balance at December 31, 2015
|
$
|
54,422
|
|
|
$
|
23,737
|
|
Total losses (gains) for the period:
|
|
|
|
||||
Included in results of operations
|
16,954
|
|
|
(7,001
|
)
|
||
Foreign currency impact
|
(1
|
)
|
|
—
|
|
||
Payments
|
(26,299
|
)
|
|
—
|
|
||
Balance at December 31, 2016
|
$
|
45,076
|
|
|
$
|
16,736
|
|
(In thousands)
|
Balance Sheet Component
|
|
December 31,
2017 |
|
December 31,
2016 |
||||
Derivative financial instruments:
|
|
|
|
|
|
||||
Common stock options/warrants
|
Investments, net
|
|
$
|
3,333
|
|
|
$
|
4,017
|
|
Embedded conversion option
|
2033 Senior Notes, net of discount
|
|
$
|
—
|
|
|
$
|
16,736
|
|
Forward contracts
|
Unrealized gains on forward contracts are recorded in Other current assets and prepaid expenses. Unrealized (losses) on forward contracts are recorded in Accrued expenses.
|
|
$
|
(317
|
)
|
|
$
|
39
|
|
|
For the years ended December 31,
|
||||||||||
(In thousands)
|
2017
|
|
2016
|
|
2015
|
||||||
Derivative gain (loss):
|
|
|
|
|
|
||||||
Common stock options/warrants
|
$
|
(2,533
|
)
|
|
$
|
(4,262
|
)
|
|
$
|
(2,854
|
)
|
2033 Senior Notes
|
3,185
|
|
|
7,001
|
|
|
(36,588
|
)
|
|||
Forward contracts
|
$
|
(600
|
)
|
|
$
|
39
|
|
|
$
|
359
|
|
Total
|
$
|
52
|
|
|
$
|
2,778
|
|
|
$
|
(39,083
|
)
|
|
For the 2017 Quarters Ended
|
||||||||||||||
(In thousands, except per share data)
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Total revenues
|
$
|
296,096
|
|
|
$
|
314,213
|
|
|
$
|
263,495
|
|
|
$
|
193,699
|
|
Total costs and expenses
|
337,803
|
|
|
340,656
|
|
|
321,785
|
|
|
347,321
|
|
||||
Net income (loss)
|
(30,995
|
)
|
|
(17,528
|
)
|
|
(46,442
|
)
|
|
(213,905
|
)
|
||||
Net income (loss) attributable to common shareholders
|
(30,995
|
)
|
|
(17,528
|
)
|
|
(46,442
|
)
|
|
(213,905
|
)
|
||||
Earnings (loss) per share, basic
|
$
|
(0.06
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.38
|
)
|
Earnings (loss) per share, diluted
|
$
|
(0.06
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.38
|
)
|
|
|
|
|
|
|
|
|
||||||||
|
For the 2016 Quarters Ended
|
||||||||||||||
(In thousands, except per share data)
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Total revenues
|
$
|
291,037
|
|
|
$
|
357,100
|
|
|
$
|
298,035
|
|
|
$
|
275,489
|
|
Total costs and expenses
|
318,555
|
|
|
328,834
|
|
|
321,658
|
|
|
325,889
|
|
||||
Net income (loss)
|
(11,978
|
)
|
|
15,533
|
|
|
(14,977
|
)
|
|
(13,661
|
)
|
||||
Net income (loss) attributable to common shareholders
|
(11,978
|
)
|
|
15,533
|
|
|
(14,977
|
)
|
|
(13,661
|
)
|
||||
Earnings (loss) per share, basic
|
$
|
(0.02
|
)
|
|
$
|
0.03
|
|
|
$
|
(0.03
|
)
|
|
$
|
(0.02
|
)
|
Earnings (loss) per share, diluted
|
$
|
(0.02
|
)
|
|
$
|
0.02
|
|
|
$
|
(0.03
|
)
|
|
$
|
(0.04
|
)
|
(a)
|
(1)
|
Financial Statements: See Part II, Item 8 of this report.
|
|
|
Schedule I - Condensed Financial Information of Registrant. Additionally, the financial statement schedule entitled “Schedule II – Valuation and Qualifying Accounts” has been omitted since the information required is included in the consolidated financial statements and notes thereto. Other schedules are omitted because they are not required.
|
|
(2)
|
Exhibits: See below.
|
Exhibit
Number
|
Description
|
1.1
(12)
|
Underwriting Agreement, dated March 9, 2011, by and among OPKO Health, Inc., Jefferies & Company, Inc. and J.P. Morgan Securities LLC, as representatives for the underwriters named therein.
|
|
|
2.1
(1)
|
Merger Agreement and Plan of Reorganization, dated as of March 27, 2007, by and among Acuity Pharmaceuticals, Inc., Froptix Corporation, eXegenics Inc., e-Acquisition Company I-A, LLC, and e-Acquisition Company II-B, LLC.
|
|
|
2.2
(3)+
|
Securities Purchase Agreement, dated May 2, 2008, by and among Vidus Ocular, Inc., OPKO Instrumentation, LLC, OPKO Health, Inc., and the individual sellers and noteholders named therein.
|
|
|
2.3
(9)
|
Purchase Agreement, dated February 17, 2010, by and among Ignacio Levy García and José de Jesús Levy García, Inmobiliaria Chapalita, S.A. de C.V., Pharmacos Exakta, S.A. de C.V., OPKO Health, Inc., OPKO Health Mexicana S. de R.L. de C.V., and OPKO Manufacturing Facilities S. de R.L. de C.V.
|
|
|
2.4
(14)+
|
Agreement and Plan of Merger, dated January 28, 2011, by and among CURNA, Inc., KUR, LLC, OPKO Pharmaceuticals, LLC, OPKO CURNA, LLC, and certain individuals named therein.
|
|
|
2.5
(15)
|
Agreement and Plan of Merger, dated October 13, 2011, by and among OPKO Health, Inc., Claros Merger Subsidiary, LLC, Claros Diagnostics, Inc., and Ellen Baron, Marc Goldberg and Michael Magliochetti on behalf of the Shareholder Representative Committee.
|
|
|
2.6
(17)+
|
Stock Purchase Agreement, dated December 20, 2011, by and among FineTech Pharmaceutical Ltd., Arie Gutman, OPKO Holdings Israel Ltd, and OPKO Health, Inc.
|
|
|
2.7
(18)
|
Purchase Agreement, dated January 20, 2012, by and among OPKO Health, Inc., OPKO Chile S.A., Samuel Alexandre Arama, Inversiones SVJV Limitada, Bruno Sergiani, Inversiones BS Limitada, Pierre-Yves LeGoff, and Inversiones PYTT Limitada.
|
|
|
2.8
(19)+
|
Stock Purchase Agreement, dated August 2, 2012, by and among Farmadiet Group Holding, S.L., the Sellers party thereto, OPKO Health, Inc., and Shebeli XXI, S.L.U.
|
|
|
2.9
(21)+
|
Agreement and Plan of Merger, dated October 18, 2012, by and among Prost-Data, Inc. d/b/a OurLab, Our Labs, Endo Labs and Gold Lab, Jonathan Oppenheimer, M.D., OPKO Health, Inc., OPKO Laboratories Inc., and OPKO Labs, LLC.
|
|
|
2.10
(22)+
|
Share Purchase Agreement, dated January 8, 2013, by among Cytochroma Inc., Cytochroma Holdings ULC, Cytochroma Canada Inc., Cytochroma Development Inc., Proventiv Therapeutics, LLC, Cytochroma Cayman Islands, Ltd., OPKO Health, Inc., and OPKO IP Holdings, Inc.
|
|
|
2.11
(23)
|
Asset Purchase Agreement, dated March 1, 2013, by and between RXi Pharmaceuticals Corporation and OPKO Health, Inc.
|
|
|
2.12
(24)
|
Agreement and Plan of Merger, dated April 23, 2013, by and among OPKO Health, Inc., POM Acquisition Inc., and PROLOR Biotech, Inc.
|
|
|
2.13
(27)+
|
Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited, OPKO Health, Inc. and the Sellers named therein.
|
|
|
2.14
(27)+
|
Form of Additional Agreement for the Sale and Purchase of Shares in EirGen Pharma Limited, dated May 5, 2015 by and among OPKO Ireland Limited and the Sellers named therein.
|
|
|
2.15
(28)+
|
Agreement and Plan of Merger by and among the Company, Bamboo Acquisition, Inc. and Bio-Reference Laboratories, Inc. dated as of June 3, 2015.
|
|
|
2.16(
31)
|
Arrangement Agreement by and among the Company, OPKO Global Holdings, Inc. and Transition Therapeutics Inc. dated as of June 29, 2016.
|
|
|
3.1
(26)
|
Amended and Restated Certificate of Incorporation, as amended.
|
|
|
3.2
(2)
|
Amended and Restated Bylaws.
|
|
|
3.3
(7)
|
Certificate of Designation of Series D Preferred Stock.
|
|
|
4.1
(1)
|
Form of Common Stock Warrant.
|
|
|
4.2
(7)
|
Form of Common Stock Warrant.
|
|
|
4.3
(25)
|
Indenture, dated January 30, 2013, between OPKO Health, Inc. and Wells Fargo Bank, National Association.
|
|
|
10.1
(1)
|
Form of Lockup Agreement.
|
|
|
10.2
(2)
|
Stock Purchase Agreement, dated December 4, 2007, by and between OPKO Health, Inc. and the members of The Frost Group, LLC.
|
|
|
10.3
(3)
|
Form of Director Indemnification Agreement.
|
|
|
10.4
(3)
|
Form of Officer Indemnification Agreement.
|
|
|
10.5
(4)
|
Stock Purchase Agreement, dated August 8, 2008 by and between OPKO Health, Inc. and the Purchasers named therein.
|
10.6
(5)
|
Stock Purchase Agreement, dated February 23, 2009 by and between OPKO Health, Inc. and Frost Gamma Investments Trust.
|
|
|
10.7
(6)
|
Form of Stock Purchase Agreement for transactions between OPKO Health, Inc. and Nora Real Estate SA., Vector Group Ltd., Oracle Partners LP, Oracle Institutional Partners, LP., Chung Chia Company Limited, Gold Sino Assets Limited, and Grandtime Associates Limited.
|
|
|
10.8
(6)
|
Stock Purchase Agreement, dated June 10, 2009, by and among OPKO Health, Inc. and Sorrento Therapeutics, Inc.
|
|
|
10.9
(7)
|
Form of Securities Purchase Agreement for Series D Preferred Stock.
|
|
|
10.10
(8)*
|
Form of Restricted Share Award Agreement for Directors.
|
|
|
10.11
(8)
|
Cocrystal Discovery, Inc. Agreements.
|
|
|
10.12
(11)
|
Stock Purchase Agreement, dated October 1, 2009, by and among the Laboratoria Volta S.A., Farmacias Ahumada S.A., FASA Chile S.A., OPKO Chile Limitada and Inversones OPKO Limitada, subsidiaries of OPKO Health, Inc.
|
|
|
10.13
(10)+
|
Asset Purchase Agreement, dated October 12, 2009, by and between OPKO Health, Inc. and Schering Corporation.
|
|
|
10.14
(10)
|
Letter Agreement, dated June 29, 2010, by and between OPKO Health, Inc. and Schering Corporation.
|
|
|
10.15
(16)+
|
Exclusive License Agreement by and between TESARO, Inc. and OPKO Health, Inc. dated December 10, 2010.
|
|
|
10.16
(13)
|
Third Amended and Restated Subordinated Note and Security Agreement, dated February 22, 2011, between OPKO Health, Inc. and The Frost Group, LLC.
|
|
|
10.17
(15)+
|
Asset Purchase Agreement dated September 21, 2011, by and among Optos plc, Optos Inc., OPKO Health, Inc., OPKO Instrumentation, LLC, Ophthalmic Technologies, Inc., and OTI (UK) Limited.
|
|
|
10.18
(20)
|
Form of Note Purchase Agreement, dated as of January 25, 2013, by and among OPKO Health, Inc. and each purchaser a party thereto.
|
|
|
10.19
(29)+
|
Development and Commercialization License Agreement by and between OPKO Ireland, Ltd., a subsidiary of OPKO Health, Inc., and Pfizer, Inc. dated December 13, 2014.
|
|
|
10.20
(32)
|
Credit Agreement by and between Bio-Reference Laboratories, Inc. and certain of its subsidiaries and JPMorgan Chase Bank, N.A. dated November 5, 2015.
|
|
|
10.21
(33)
|
OPKO Health, Inc. 2016 Equity Incentive Plan.
|
|
|
10.22
(34)
|
Development and License Agreement between OPKO Health, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 8, 2016.
|
|
|
10.23
(35)
|
Amendment No. 3 to Credit Agreement, dated as of March 17, 2017, among Bio-Reference Laboratories, Inc. and certain of its subsidiaries and JPMorgan Chase Bank, N.A.
|
|
|
10.24
(36)
|
Amendment No. 4 to Credit Agreement, dated as of August 7, 2017, among Bio-Reference Laboratories, Inc. and certain of its subsidiaries and JPMorgan Chase Bank, N.A.
|
|
|
10.25
(36)
|
Commitment Letter by and between OPKO Health, Inc. and Veterans Accountable Care Group, LLC, dated August 15, 2017
|
|
|
10.26
+**
|
Development and License Agreement by and between EirGen Pharma Limited, a subsidiary of OPKO Health, Inc., and Japan Tobacco Inc., dated October 12, 2017.
|
|
|
10.27
**
|
Amendment No. 5 to Credit Agreement, dated as of November 8, 2017, among Bio-Reference Laboratories, Inc. and certain of its subsidiaries and JPMorgan Chase Bank, N.A.
|
|
|
10.28
**
|
Amendment No. 6 to Credit Agreement, dated as of December 22, 2017, among Bio-Reference Laboratories, Inc. and certain of its subsidiaries and JPMorgan Chase Bank, N.A.
|
|
|
10.29
**
|
Form of 5% Convertible Promissory Note dated February 27, 2018.
|
|
|
Subsidiaries of the Company.
|
*
|
Denotes management contract or compensatory plan or arrangement.
|
**
|
Filed herewith.
|
+
|
Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
|
(1)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 2, 2007, and incorporated herein by reference.
|
(2)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2008 and incorporated herein by reference.
|
(3)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2008 for the Company’s three-month period ended June 30, 2008, and incorporated herein by reference.
|
(4)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2008 for the Company’s three-month period ended September 30, 2008, and incorporated herein by reference.
|
(5)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 8, 2009 for the Company’s three-month period ended March 31, 2009, and incorporated herein by reference.
|
(6)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2009 for the Company’s three-month period ended June 30, 2009, and incorporated herein by reference.
|
(7)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 24, 2009, and incorporated herein by reference.
|
(8)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2009 for the Company’s three-month period ended September 30, 2009, and incorporated herein by reference.
|
(9)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2010 for the Company’s three-month period ended March 31, 2010, and incorporated herein by reference.
|
(10)
|
Filed with the Company’s Amendment to Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 3, 2011.
|
(11)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2010.
|
(12)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 10, 2011, and incorporated herein by reference.
|
(13)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2011 for the Company’s three-month period ended March 31, 2011, and incorporated herein by reference.
|
(14)
|
Filed with the Company’s Quarterly Report on Form 10-Q/A filed with the Securities and Exchange Commission on July 5, 2011, and incorporated herein by reference.
|
(15)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2011 for the Company’s three-month period ended September 30, 2011, and incorporated herein by reference.
|
(16)
|
Filed with the Company’s Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on July 28, 2011.
|
(17)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2012.
|
(18)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2012 for the Company’s three-month period ended March 31, 2012, and incorporated herein by reference.
|
(19)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2012 for the Company’s three-month period ended September 30, 2012, and incorporated herein by reference.
|
(20)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 29, 2013, and incorporated herein by reference.
|
(21)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2013.
|
(22)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2013 for the Company’s three-month period ended March 31, 2013, and incorporated herein by reference.
|
(23)
|
Filed with the Company’s Schedule 13D filed with the Securities and Exchange Commission on March 22, 2013, and incorporated herein by reference.
|
(24)
|
Filed as Annex A to the Company’s Preliminary Joint Proxy Statement/Prospectus, Form S-4, with the Securities Exchange Commission on June 27, 2013, as amended, and incorporated herein by reference.
|
(25)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2013, and incorporated herein by reference.
|
(26)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2013 for the Company’s three month period ended September 30, 2013, and incorporated herein by reference.
|
(27)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2015 for the Company’s three month period ended June 30, 2015, and incorporated herein by reference.
|
(28)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 4, 2015, and incorporated herein by reference.
|
(29)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2015, and incorporated herein by reference.
|
(30)
|
Filed under Part II, Item 8, of the Bio-Reference Laboratories, Inc. Form 10-K filed with the Securities and Exchange Commission on January 13, 2015 (File No. 0-15266), and incorporated herein by reference.
|
(31)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 30, 2016 and incorporated herein by reference.
|
(32)
|
Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 29, 2016, and incorporated herein by reference.
|
(33)
|
Filed with the Company’s Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on March 25, 2016, and incorporated herein by reference.
|
(34)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2016 for the Company’s three month period ended June 30, 2016, and incorporated herein by reference.
|
(35)
|
Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 23, 2017 and incorporated herein by reference.
|
(36)
|
Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2017 and incorporated herein by reference.
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
21,385
|
|
|
$
|
15,744
|
|
Other current assets and prepaid expenses
|
4,586
|
|
|
12,446
|
|
||
Total current assets
|
25,971
|
|
|
28,190
|
|
||
Property, plant and equipment, net
|
150
|
|
|
503
|
|
||
Investments
|
1,893,371
|
|
|
2,114,473
|
|
||
Other assets
|
146
|
|
|
176
|
|
||
Total assets
|
$
|
1,919,638
|
|
|
$
|
2,143,342
|
|
LIABILITIES AND EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,077
|
|
|
$
|
1,070
|
|
Accrued expenses
|
3,023
|
|
|
5,769
|
|
||
Current portion of notes payable
|
521
|
|
|
522
|
|
||
Total current liabilities
|
4,621
|
|
|
7,361
|
|
||
2033 Senior Notes, net of discount
|
29,160
|
|
|
43,701
|
|
||
Deferred tax liabilities, net
|
479
|
|
|
472
|
|
||
Total long-term liabilities
|
29,639
|
|
|
44,173
|
|
||
Total liabilities
|
34,260
|
|
|
51,534
|
|
||
Equity:
|
|
|
|
||||
Common Stock - $0.01 par value, 750,000,000 shares authorized; 560,023,745 and 558,576,051
shares issued at December 31, 2017 and 2016, respectively |
5,600
|
|
|
5,586
|
|
||
Treasury Stock, at cost - 549,907 and 586,760 shares at December 31, 2017 and 2016,
respectively |
(1,791
|
)
|
|
(1,911
|
)
|
||
Additional paid-in capital
|
2,889,256
|
|
|
2,845,096
|
|
||
Accumulated other comprehensive income (loss)
|
(528
|
)
|
|
(27,009
|
)
|
||
Accumulated deficit
|
(1,007,159
|
)
|
|
(729,954
|
)
|
||
Total shareholders’ equity
|
1,885,378
|
|
|
2,091,808
|
|
||
Total liabilities and equity
|
$
|
1,919,638
|
|
|
$
|
2,143,342
|
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Revenue from products
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
140
|
|
Revenue from transfer of intellectual property and other
|
1,069
|
|
|
—
|
|
|
154
|
|
|||
Total revenues
|
1,069
|
|
|
—
|
|
|
294
|
|
|||
Costs and expenses:
|
|
|
|
|
|
||||||
Costs of revenue
|
1,438
|
|
|
875
|
|
|
798
|
|
|||
Selling, general and administrative
|
57,410
|
|
|
60,819
|
|
|
47,708
|
|
|||
Research and development
|
4,426
|
|
|
3,791
|
|
|
8,496
|
|
|||
Total costs and expenses
|
63,274
|
|
|
65,485
|
|
|
57,002
|
|
|||
Operating loss
|
(62,205
|
)
|
|
(65,485
|
)
|
|
(56,708
|
)
|
|||
Other income and (expense), net:
|
|
|
|
|
|
||||||
Interest income
|
260
|
|
|
440
|
|
|
5
|
|
|||
Interest expense
|
(4,426
|
)
|
|
(3,585
|
)
|
|
(5,347
|
)
|
|||
Fair value changes of derivative instruments, net
|
652
|
|
|
2,738
|
|
|
(39,442
|
)
|
|||
Other income (expense), net
|
5,177
|
|
|
(2,387
|
)
|
|
2,141
|
|
|||
Other income and (expense), net
|
1,663
|
|
|
(2,794
|
)
|
|
(42,643
|
)
|
|||
Loss before income taxes and investment losses
|
(60,542
|
)
|
|
(68,279
|
)
|
|
(99,351
|
)
|
|||
Income tax benefit (provision)
|
(247
|
)
|
|
(686
|
)
|
|
—
|
|
|||
Net loss before investment losses
|
(60,789
|
)
|
|
(68,965
|
)
|
|
(99,351
|
)
|
|||
Loss from investments in investees
|
(12,646
|
)
|
|
(7,665
|
)
|
|
(7,105
|
)
|
|||
Net income (loss) from subsidiaries, net of taxes
|
(235,435
|
)
|
|
51,547
|
|
|
76,428
|
|
|||
Net loss attributable to common shareholders
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(30,028
|
)
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net loss
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(30,028
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
||||||
Change in foreign currency translation and other comprehensive income (loss)
|
22,724
|
|
|
(4,955
|
)
|
|
(15,074
|
)
|
|||
Available for sale investments:
|
|
|
|
|
|
||||||
Change in unrealized gain (loss), net of tax
|
3,790
|
|
|
(3,810
|
)
|
|
(2,378
|
)
|
|||
Less: reclassification adjustments for losses included in net loss, net of tax
|
(33
|
)
|
|
4,293
|
|
|
7,307
|
|
|||
Comprehensive loss attributable to common shareholders
|
$
|
(282,389
|
)
|
|
$
|
(29,555
|
)
|
|
$
|
(40,173
|
)
|
|
For the years ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(308,870
|
)
|
|
$
|
(25,083
|
)
|
|
$
|
(30,028
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
138
|
|
|
89
|
|
|
85
|
|
|||
Non-cash interest
|
2,049
|
|
|
1,866
|
|
|
2,612
|
|
|||
Amortization of deferred financing costs
|
574
|
|
|
149
|
|
|
1,212
|
|
|||
Losses from investments in investees
|
12,646
|
|
|
7,665
|
|
|
7,105
|
|
|||
(Income) loss from subsidiaries
|
235,435
|
|
|
(51,546
|
)
|
|
(76,428
|
)
|
|||
Equity-based compensation – employees and non-employees
|
28,308
|
|
|
42,693
|
|
|
26,074
|
|
|||
Realized loss (gain) on equity securities and disposal of fixed assets
|
(652
|
)
|
|
(2,738
|
)
|
|
7,091
|
|
|||
Loss (gain) on conversion of 3.00% convertible senior notes
|
—
|
|
|
284
|
|
|
(943
|
)
|
|||
Change in fair value of derivative instruments
|
(4,953
|
)
|
|
2,347
|
|
|
39,442
|
|
|||
Gain on deconsolidation of SciVac
|
—
|
|
|
—
|
|
|
(15,940
|
)
|
|||
Changes in other assets and liabilities
|
4,258
|
|
|
(6,844
|
)
|
|
(15,640
|
)
|
|||
Net cash used in operating activities
|
(31,067
|
)
|
|
(31,118
|
)
|
|
(55,358
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Investments in investees
|
(9,625
|
)
|
|
(14,424
|
)
|
|
(4,375
|
)
|
|||
Subsidiary financing
|
41,990
|
|
|
(44,569
|
)
|
|
62,471
|
|
|||
Proceeds from sale of equity securities
|
2,211
|
|
|
—
|
|
|
—
|
|
|||
Acquisition of businesses, net of cash acquired
|
—
|
|
|
—
|
|
|
(138
|
)
|
|||
Capital expenditures
|
—
|
|
|
(368
|
)
|
|
(92
|
)
|
|||
Net cash provided by (used in) investing activities
|
34,576
|
|
|
(59,361
|
)
|
|
57,866
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Proceeds from the exercise of Common Stock options and warrants
|
2,132
|
|
|
8,576
|
|
|
25,921
|
|
|||
Net cash provided by financing activities
|
2,132
|
|
|
8,576
|
|
|
25,921
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
5,641
|
|
|
(81,903
|
)
|
|
28,429
|
|
|||
Cash and cash equivalents at beginning of period
|
15,744
|
|
|
97,647
|
|
|
69,218
|
|
|||
Cash and cash equivalents at end of period
|
$
|
21,385
|
|
|
$
|
15,744
|
|
|
$
|
97,647
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
|
|
||||||
Interest paid
|
$
|
956
|
|
|
$
|
966
|
|
|
$
|
2,175
|
|
Income taxes paid, net of refunds
|
$
|
327
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Non-cash financing:
|
|
|
|
|
|
||||||
Shares issued upon the conversion of:
|
|
|
|
|
|
||||||
2033 Senior Notes
|
$
|
—
|
|
|
$
|
583
|
|
|
$
|
120,299
|
|
Common Stock options and warrants, surrendered in net exercise
|
$
|
1,546
|
|
|
$
|
350
|
|
|
$
|
14,369
|
|
Issuance of capital stock to acquire or contingent consideration settlement:
|
|
|
|
|
|
||||||
Transition Therapeutics, Inc.
|
$
|
—
|
|
|
$
|
58,530
|
|
|
$
|
—
|
|
BioReference Laboratories, Inc.
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
950,148
|
|
EirGen Pharma Limited
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,569
|
|
OPKO Renal
|
$
|
—
|
|
|
$
|
25,986
|
|
|
$
|
20,113
|
|
OPKO Health Europe
|
$
|
303
|
|
|
$
|
313
|
|
|
$
|
1,813
|
|
Issuance of stock for investment in Xenetic
|
$
|
—
|
|
|
$
|
4,856
|
|
|
$
|
—
|
|
(In thousands)
|
Embedded conversion option
|
|
2033 Senior Notes
|
|
Discount
|
|
Debt Issuance Cost
|
|
Total
|
||||||||||
Balance at December 31, 2016
|
$
|
16,736
|
|
|
$
|
31,850
|
|
|
$
|
(4,612
|
)
|
|
$
|
(273
|
)
|
|
$
|
43,701
|
|
Amortization of debt discount and debt issuance costs
|
—
|
|
|
—
|
|
|
2,047
|
|
|
148
|
|
|
2,195
|
|
|||||
Change in fair value of embedded derivative
|
(3,185
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,185
|
)
|
|||||
Reclassification of embedded derivatives to equity
|
(13,551
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,551
|
)
|
|||||
Balance at December 31, 2017
|
$
|
—
|
|
|
$
|
31,850
|
|
|
$
|
(2,565
|
)
|
|
$
|
(125
|
)
|
|
$
|
29,160
|
|
(In thousands)
|
Embedded conversion option
|
|
2033 Senior Notes
|
|
Discount
|
|
Debt Issuance Cost
|
|
Total
|
||||||||||
Balance at December 31, 2015
|
$
|
23,737
|
|
|
$
|
32,200
|
|
|
$
|
(6,525
|
)
|
|
$
|
(426
|
)
|
|
$
|
48,986
|
|
Amortization of debt discount and debt issuance costs
|
—
|
|
|
—
|
|
|
1,913
|
|
|
153
|
|
|
2,066
|
|
|||||
Change in fair value of embedded derivative
|
(7,001
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,001
|
)
|
|||||
Conversion
|
—
|
|
|
(350
|
)
|
|
—
|
|
|
—
|
|
|
(350
|
)
|
|||||
Balance at December 31, 2016
|
$
|
16,736
|
|
|
$
|
31,850
|
|
|
$
|
(4,612
|
)
|
|
$
|
(273
|
)
|
|
$
|
43,701
|
|
Date: March 1, 2018
|
OPKO HEALTH, INC.
|
|
|
|
|
|
By:
|
/s/ Phillip Frost, M.D.
|
|
|
Phillip Frost, M.D.
|
|
|
Chairman of the Board and
|
|
|
Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
/s/ Phillip Frost, M.D.
|
|
Chairman of the Board and Chief Executive
|
|
March 1, 2018
|
Phillip Frost, M.D.
|
|
Officer
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ Jane H. Hsiao, Ph.D., MBA
|
|
Vice Chairman and Chief Technical Officer
|
|
March 1, 2018
|
Jane H. Hsiao, Ph.D., MBA
|
|
|
|
|
|
|
|
|
|
/s/ Steven D. Rubin
|
|
Director and Executive Vice President –
|
|
March 1, 2018
|
Steven D. Rubin
|
|
Administration
|
|
|
|
|
|
|
|
/s/ Adam Logal
|
|
Senior Vice President, Chief Financial Officer,
|
|
March 1, 2018
|
Adam Logal
|
|
Chief Accounting Officer and Treasurer
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ Richard Krasno, Ph.D.
|
|
Director
|
|
March 1, 2018
|
Richard Krasno, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Richard A. Lerner, M.D.
|
|
Director
|
|
March 1, 2018
|
Richard A. Lerner, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ John A. Paganelli
|
|
Director
|
|
March 1, 2018
|
John A. Paganelli
|
|
|
|
|
|
|
|
|
|
/s/ Richard C. Pfenniger, Jr.
|
|
Director
|
|
March 1, 2018
|
Richard C. Pfenniger, Jr.
|
|
|
|
|
|
|
|
|
|
/s/ Alice Lin-Tsing Yu, M.D., Ph.D.
|
|
Director
|
|
March 1, 2018
|
Alice Lin-Tsing Yu, M.D., Ph.D.
|
|
|
|
|
Exhibit Number
|
Description
|
|
|
21
|
Subsidiaries of the Company.
|
|
|
23.1
|
Consent of Ernst & Young LLP.
|
|
|
31.1
|
Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2017.
|
|
|
31.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2017.
|
|
|
32.1
|
Certification by Phillip Frost, Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2017.
|
|
|
32.2
|
Certification by Adam Logal, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2017.
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Capitalized Term
|
Section
|
Expanded License
|
4.1
|
Extended Payment Term
|
3.2
|
Incumbent Board
|
1.1
|
Indemnitee
|
17.7
|
Initial Term
|
5.5(c)
|
Inventions
|
13.1(a)
|
JDC
|
9.1(a)
|
Joint Inventions
|
13.1(b)
|
JPO Registration Request
|
13.5(a)
|
JSC
|
9.1(a)
|
Licensee
|
Preamble
|
Licensee Additional Indication
|
4.2(a)
|
Licensee Additional Indication Negotiation Period
|
4.2(d)
|
Licensee Additional Indication Notice
|
4.2(a)
|
Licensee Inventions
|
13.1(c)
|
Licensee Notice of Exercise
|
4.1(b)
|
Licensee Option
|
4.1
|
Licensee Prosecution Patents
|
13.2(b)
|
Licensee Trademark
|
8.2(c)
|
Losses
|
17.5
|
Minimum OPKO Consideration Period
|
Schedule 2.2(a)
|
[***]
|
13.14(b)
|
OPKO
|
Preamble
|
OPKO Additional Indication
|
4.1(a)
|
OPKO Additional Indication Negotiation Period
|
4.1(c)
|
OPKO Additional Indication Notice
|
4.1(a)
|
OPKO Consideration Period
|
Schedule 2.2(a)
|
OPKO Inventions
|
13.1(a)
|
OPKO Phase II Study
|
6.3
|
OPKO Prosecution Patents
|
13.2(a)
|
OPKO Response Notice
|
4.2(b)
|
Option Finalization Period
|
Schedule 2.2(a)
|
Capitalized Term
|
Section
|
Option Negotiation Period
|
Schedule 2.2(a)
|
Parties
|
Preamble
|
Party
|
Preamble
|
Party Vote
|
9.1(c)
|
Paying Party
|
5.9(a)
|
Pharmacovigilance Agreement
|
11.2
|
Publication
|
6.4
|
Quality Agreement
|
10.2
|
Recall
|
7.5
|
Receiving Party
|
5.9(a)
|
Regulatory Action
|
7.4
|
Reimbursable Expenses
|
6.7
|
Relevant Patents
|
13.14(a)
|
ROFR
|
2.6
|
ROFR Exercise Notice
|
2.6
|
ROFR Negotiation Period
|
2.6
|
ROFR Notice
|
2.6
|
Royalty Payments
|
5.4
|
Royalty Term
|
5.5
|
SHPT
|
1.1
|
Supplemental Component
|
1.1
|
Supply Agreement
|
10.2
|
Tax Documents
|
5.1
|
Term
|
3.1
|
Torii
|
Recitals
|
Milestone Event
|
Milestone Payment
(in United States Dollars)
|
1.
Initiation of the [***] in the License Territory
|
$[***]
|
2.
[***] in the License Territory for the prevention or treatment of [***]
|
$[***]
|
3.
[***] in the License Territory (a) for the prevention or treatment of [***] patients, or (b) for any other Initial Indication
|
$[***]
|
4.
[***] in the License Territory for the prevention or treatment of [***]
|
$[***]
|
5.
[***] in the License Territory (a) for the prevention or treatment of [***] patients, or (b) for any other Initial Indication
|
$[***]
|
6.
First time aggregate Net Sales of Products in the License Territory exceed [***] in an Agreement Year
|
$[***]
|
7.
First time aggregate Net Sales of Products in the License Territory exceed [***] in an Agreement Year
|
$[***]
|
Aggregate Net Sales in an Agreement Year
|
Applicable Percentage
|
For the portion up to and including [***]
|
[***]
|
For the portion in excess of [***] up to and including [***]
|
[***]
|
For the portion in excess of [***] up to and including [***]
|
[***]
|
For the portion in excess of [***]
|
[***]
|
EIRGEN PHARMA LIMITED
|
|
|
|
By:
|
/s/ Patsy Carny
|
Name:
|
Patsy Carney
|
Title:
|
CEO
|
JAPAN TABACCO INC.
|
|
|
|
By:
|
/s/ Muneaki Fujimoto
|
Name:
|
Muneaki Fujimoto
|
Title:
|
President, Pharmaceutical Business
|
OPKO HEALTH, INC.
|
|
|
|
By:
|
|
Name:
|
Adam Logal
|
Title:
|
Senior Vice President, Chief Financial Officer
|
Ctry
|
App No.
|
Filed
|
Publication No.
|
Publication Date
|
Patent No.
|
Issue Date
|
Status
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Parties
|
[***]
|
Definitions
|
[***]
|
Background
|
[***]
|
Forecasting
|
[***]
|
Ordering
|
[***]
|
Delivery; Risk of Loss
|
[***]
|
Acceptance or Rejection
|
[***]
|
Pricing
|
[***]
|
Payment
|
[***]
|
Term and Termination
|
[***]
|
Quality Agreement
|
[***]
|
Back-up Rights
|
[***]
|
Indemnification
|
[***]
|
Facility Inspection
|
[***]
|
Governing Law
|
[***]
|
Other Terms
|
[***]
|
BORROWERS:
|
||
|
|
|
BIO-REFERENCE LABORATORIES, INC.
|
||
GENEDX, INC.
|
||
FLORIDA CLINICAL LABORATORY, INC.
|
||
MERIDIAN CLINICAL LABORATORY
|
||
CORP.
|
||
|
|
|
|
|
|
By:
|
/s/ Adam Logal
|
|
|
Name:
|
Adam Logal
|
|
Title:
|
Director, Vice President
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER LOAN PARTIES:
|
||
|
|
|
CAREEVOLVE.COM, INC.
|
||
BRLI-GENPATH DIAGNOSTICS, INC.
|
||
GENEDX MENA LLC
|
||
|
|
|
|
|
|
By:
|
/s/ Adam Logal
|
|
|
Name:
|
Adam Logal
|
|
Title:
|
Director, Vice President
|
|
|
|
Approved for Signature
|
|
OPKO Legal Department
|
|
By:
|
/s/Kate Inman
|
Date:
|
November 8, 2017
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JPMORGAN CHASE BANK, N.A.,
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Individually as a Lender and as Administrative
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Agent, Issuing Bank and Swingline Lender
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By:
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/s/ Eric A. Anderson
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Name:
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Eric A. Anderson
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Title:
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Authorized Officer
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BORROWERS:
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BIO-REFERENCE LABORATORIES, INC.
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GENEDX, INC.
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FLORIDA CLINICAL LABORATORY, INC.
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MERIDIAN CLINICAL LABORATORY CORP.
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By:
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/s/ Adam Logal
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Name:
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Adam Logal
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Title:
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Director, Vice President
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OTHER LOAN PARTIES:
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CAREEVOLVE.COM, INC.
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BRLI-GENPATH DIAGNOSTICS, INC.
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GENEDX MENA LLC
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By:
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/s/ Adam Logal
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Name:
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Adam Logal
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Title:
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Director, Vice President
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JPMORGAN CHASE BANK, N.A.,
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Individually as a Lender and as Administrative
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Agent, Issuing Bank and Swingline Lender
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By:
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/s/ Eric A. Anderson
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Name:
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Eric A. Anderson
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Title:
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Authorized Officer
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OPKO HEALTH, INC.
By:__________________________
Name:
Title:
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Acknowledged and agreed by Lender as of the date first set forth above:
_______________________
By:__________________________
Name:
Title:
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Payment Instructions for Lender:
If by wire:
Bank: ______________________
ABA#: ______________________
Account # ______________________
Beneficiary: ______________________
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NAME
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JURISDICTION OF INCORPORATION
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OPKO Instrumentation, LLC
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Delaware
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OPKO Pharmaceuticals, LLC
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Delaware
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OPKO Diagnostics, LLC
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Delaware
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OPKO Chile, S.A.
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Chile
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Arama Natural Products Distribuidora, Ltda
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Chile
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Pharmacos Exakta S.A. de C.V.
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Mexico
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FineTech Pharmaceutical Ltd
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Israel
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Farmadiet Group Holdings, S.C.
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Spain
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OPKO Biologics, Ltd
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Israel
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OPKO Ireland Global Holdings, Ltd
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Ireland
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OPKO Ireland, Ltd
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Ireland
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OPKO Canada Corp, ULC
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Canada
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OPKO Renal, LLC
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Canada
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Curna, Inc.
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Delaware
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BioReference Laboratories, Inc.
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New Jersey
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GeneDX, Inc.
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New Jersey
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Genome Diagnostics, Ltd
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Canada
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EirGen Pharma Limited
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Ireland
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Transition Therapeutics, Inc.
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Canada
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1.
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Registration Statement (Form S-8 No. 333-211209) pertaining to the 2016 Equity Incentive Plan of OPKO Health, Inc. and subsidiaries,
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2.
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Registration Statement (Form S-8 No. 333-144040) pertaining to the 2007 Equity Incentive Plan of OPKO Health, Inc. and subsidiaries,
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3.
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Registration Statement (Form S-8 No. 333-190899) pertaining to the 2005 Stock Incentive Plan and 2007 Equity Incentive Plan of PROLOR Biotech, Inc. (formerly Modigene Inc.),
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4.
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Registration Statement (Form S-8 No. 333-190900) pertaining to the 2007 Equity Incentive Plan of OPKO Health, Inc. and subsidiaries, and
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5.
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Registration Statement (Form S-8 No. 333-206489) pertaining to the 2003 Employee Incentive Stock Option Plan of BioReference Laboratories, Inc.
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(1)
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I have reviewed this Annual Report on Form 10-K of OPKO Health, Inc.;
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(2)
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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(3)
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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(4)
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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(5)
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: March 1, 2018
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/s/Phillip Frost, M.D.
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Phillip Frost, M.D.
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Chief Executive Officer
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(1)
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I have reviewed this Annual Report on Form 10-K of OPKO Health, Inc.;
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(2)
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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(3)
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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(4)
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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(5)
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: March 1, 2018
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/s/ Adam Logal
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Adam Logal
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Senior Vice President, Chief Financial Officer,
Chief Accounting Officer and Treasurer
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Date: March 1, 2018
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/s/ Phillip Frost, M.D.
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Phillip Frost, M.D.
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Chief Executive Officer
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Date: March 1, 2018
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/s/ Adam Logal
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Adam Logal
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Senior Vice President, Chief Financial Officer
Chief Accounting Officer and Treasurer
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