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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2020.
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                     .
Commission file number 001-33528
OPKO Health, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware75-2402409
(State or Other Jurisdiction of
Incorporation or Organization)
(I.R.S. Employer
Identification No.)
4400 Biscayne Blvd.
MiamiFL33137
(Address of Principal Executive Offices) (Zip Code)
(305) 575-4100
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading SymbolName of each exchange on which registered
Common Stock, par value $0.01 per shareOPKNASDAQ Global Select Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    ý  Yes    ¨  NO
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    ý  Yes    ¨  NO
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company”

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in Rule 12b-2 of the Exchange Act:
Large accelerated filerxAccelerated filer
Non-accelerated filer¨ Smaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):     YES    ý  NO

As of July 20, 2020, the registrant had 669,831,024 shares of Common Stock outstanding.

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies or prospects, including the potential impact of the COVID-19 pandemic on our businesses, operating results, cash flows and/or financial condition. You can identify forward-looking statements by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described below and in “Item 1A-Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2019 and this Quarterly Report on Form 10-Q, and described from time to time in our other filings with the Securities and Exchange Commission (the “SEC”). We do not undertake any obligation to update forward-looking statements, except to the extent required by applicable law. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance.

Risks and uncertainties, the occurrence of which could adversely affect our business, include the following:
our business may be materially adversely affected by the recent coronavirus (COVID-19) outbreak;
we have a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs;
our need for, and ability to obtain, additional financing when needed on favorable terms, or at all;
adverse results in material litigation matters or governmental inquiries, including, without limitation, pending class action and derivative lawsuits which followed the now settled lawsuit against the Company and its Chairman and Chief Executive Officer by the SEC;
the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments;
our research and development activities may not result in commercially viable products;
that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results;
the success of our relationship with Pfizer in connection with the development of hGH-CTP (Somatrogon);
that we may fail to obtain regulatory approval for hGH-CTP or successfully commercialize Rayaldee and hGH-CTP;
that we may not generate profits or cash flow from our laboratory operations or substantial revenue from Rayaldee and our other pharmaceutical and diagnostic products;
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;
our ability to build a successful pharmaceutical sales and marketing infrastructure;
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;
the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control;
our success is dependent on the involvement and continued efforts of our Chairman and Chief Executive Officer;
integration challenges for acquired businesses;
availability of insurance coverage with respect to material litigation matters;

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changes in regulation and policies in the United States (“U.S.”) and other countries, including increasing downward pressure on healthcare reimbursement;
our ability to manage our growth and our expanded operations;
increased competition, including price competition;
changing relationships with payors, including the various state and multi-state Blues programs, suppliers and strategic partners;
efforts by third-party payors to reduce utilization and reimbursement for clinical testing services;
our ability to maintain reimbursement coverage for our products and services, including the 4Kscore test;
failure to timely or accurately bill and collect for our services;
the information technology systems that we rely on may be subject to unauthorized tampering, cyberattack or other data security or privacy incidents that could impact our billing processes or disrupt our operations;
failure to obtain and retain new clients and business partners, or a reduction in tests ordered or specimens submitted by existing clients;
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;
failure to maintain the security of patient-related information;
our ability to obtain and maintain intellectual property protection for our products;
our ability to defend our intellectual property rights with respect to our products;
our ability to operate our business without infringing the intellectual property rights of others;
our ability to attract and retain key scientific and management personnel;
the risk that the carrying value of certain assets may exceed the fair value of the assets causing us to impair goodwill or other intangible assets;
failure to obtain and maintain regulatory approval outside the U.S.; and
legal, economic, political, regulatory, currency exchange, and other risks associated with international operations.


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PART I. FINANCIAL INFORMATION
Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to the “Company”, “OPKO”, “we”, “our”, “ours”, and “us” refer to OPKO Health, Inc., a Delaware corporation, including our consolidated subsidiaries.
Item 1. Financial Statements
The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share data)
June 30, 2020December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents$21,612  $85,452  
Accounts receivable, net214,352  134,617  
Inventory, net72,965  53,434  
Other current assets and prepaid expenses51,125  50,542  
Total current assets360,054  324,045  
Property, plant and equipment, net130,540  127,111  
Intangible assets, net499,125  528,962  
In-process research and development590,200  590,200  
Goodwill671,599  671,940  
Investments26,260  20,746  
Operating lease right-of-use assets38,469  39,380  
Other assets7,487  6,888  
Total assets$2,323,734  $2,309,272  
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable$44,671  $62,537  
Accrued expenses210,111  164,925  
Current maturities of operating leases10,298  12,038  
Current portion of lines of credit and notes payable14,463  9,619  
Total current liabilities279,543  249,119  
Operating lease liabilities28,759  27,665  
Convertible notes216,457  211,208  
Deferred tax liabilities, net118,979  118,717  
Other long-term liabilities, principally contract liabilities, contingent consideration and line of credit91,653  87,804  
Total long-term liabilities455,848  445,394  
Total liabilities735,391  694,513  
Equity:
Common Stock - $0.01 par value, 1,000,000,000 shares authorized; 670,378,701 and 670,378,701 shares issued at June 30, 2020 and December 31, 2019, respectively
6,704  6,704  
Treasury Stock - 549,907 shares at June 30, 2020 and December 31, 2019, respectively
(1,791) (1,791) 
Additional paid-in capital3,147,030  3,142,993  
Accumulated other comprehensive loss(25,752) (22,070) 
Accumulated deficit(1,537,848) (1,511,077) 
Total shareholders’ equity1,588,343  1,614,759  
Total liabilities and equity$2,323,734  $2,309,272  
The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
 For the three months ended June 30,For the six months ended June 30,
 2020201920202019
Revenues:
Revenue from services$250,971  $178,458  $421,811  $357,349  
Revenue from products29,356  28,680  60,430  53,981  
Revenue from transfer of intellectual property and other20,880  19,230  30,433  37,490  
Total revenues301,207  226,368  512,674  448,820  
Costs and expenses:
Cost of service revenue144,794  130,078  267,680  259,981  
Cost of product revenue17,857  14,145  35,229  28,300  
Selling, general and administrative77,721  88,475  153,852  183,633  
Research and development17,608  28,286  39,369  64,816  
Contingent consideration1,111  (3,775) 251  1,031  
Amortization of intangible assets14,937  16,419  29,874  32,981  
Asset impairment charges      655  
Total costs and expenses274,028  273,628  526,255  571,397  
Operating income (loss)27,179  (47,260) (13,581) (122,577) 
Other income and (expense), net:
Interest income5  572  147  1,127  
Interest expense(5,474) (5,501) (10,970) (10,257) 
Fair value changes of derivative instruments, net(13) (388) 608  27  
Other income (expense), net18,223  (5,874) 5,890  (4,897) 
Other income and (expense), net12,741  (11,191) (4,325) (14,000) 
Income (loss) before income taxes and investment losses39,920  (58,451) (17,906) (136,577) 
Income tax provision(6,028) (1,084) (7,200) (1,866) 
Net income (loss) before investment losses33,892  (59,535) (25,106) (138,443) 
Loss from investments in investees(189) (271) (323) (2,125) 
Net Income (loss)$33,703  $(59,806) $(25,429) $(140,568) 
Income (loss) per share, basic and diluted:
Income (loss) per share$0.05  $(0.10) $(0.04) $(0.24) 
Weighted average common shares outstanding, basic and diluted640,578,794  586,351,045  640,578,794  586,347,645  

The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(In thousands)
 For the three months ended June 30,For the six months ended June 30,
 2020201920202019
Net income (loss)$33,703  $(59,806) $(25,429) $(140,568) 
Other comprehensive income (loss), net of tax:
Change in foreign currency translation and other comprehensive income (loss)4,435  2,878  (3,682) (220) 
Comprehensive income (loss)$38,138  $(56,928) $(29,111) $(140,788) 

The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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CONSOLIDATED STATEMENTS OF EQUITY
(Unaudited)
(In thousands, except share and per share data)
For the three and six months ended June 30, 2020


 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at March 31, 2020670,378,701  $6,704  $(549,907) $(1,791) $3,145,444  $(30,187) $(1,571,551) $1,548,619  
Equity-based compensation expense—  —  —  —  1,586  —  —  1,586  
Net income—  —  —  —  —  —  33,703  33,703  
Other comprehensive income—  —  —  —  —  4,435  —  4,435  
Balance at June 30, 2020670,378,701  $6,704  $(549,907) $(1,791) $3,147,030  $(25,752) $(1,537,848) $1,588,343  



 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at December 31, 2019670,378,701  $6,704  (549,907) $(1,791) $3,142,993  $(22,070) $(1,511,077) $1,614,759  
Equity-based compensation expense—  —  —  —  4,037  —  —  4,037  
Adoption of ASC 326—  —  —  —  —  —  (1,342) (1,342) 
Net loss—  —  —  —  —  —  (25,429) (25,429) 
Other comprehensive loss—  —  —  —  —  (3,682) —  (3,682) 
Balance at June 30, 2020670,378,701  $6,704  (549,907) $(1,791) $3,147,030  $(25,752) $(1,537,848) $1,588,343  










The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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CONSOLIDATED STATEMENTS OF EQUITY
(Unaudited)
(In thousands, except share and per share data)
For the three and six months ended June 30, 2019


 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at March 31, 2019616,150,952  $6,162  (549,907) $(1,791) $3,058,509  $(23,229) $(1,276,914) $1,762,737  
Equity-based compensation expense—  —  —  —  3,122  —  —  3,122  
Net loss—  —  —  —  —  —  (59,806) (59,806) 
Other comprehensive income—  —  —  —  —  2,878  —  2,878  
Balance at June 30, 2019616,150,952  $6,162  (549,907) $(1,791) $3,061,631  $(20,351) $(1,336,720) $1,708,931  



 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at December 31, 2018586,881,720  $5,869  (549,907) $(1,791) $3,004,422  $(20,131) $(1,197,078) $1,791,291  
Equity-based compensation expense—  —  —  —  7,579  —  —  7,579  
Exercise of Common Stock options and warrants19,232  —  —  —  (3) —  —  (3) 
Adoption of ASU 2018-07—  —  —  —  (926) —  926    
2025 convertible notes including share lending arrangement29,250,000  293  —  —  50,559  —  —  50,852  
Net loss—  —  —  —  —  —  (140,568) (140,568) 
Other comprehensive loss—  —  —  —  —  (220) —  (220) 
Balance at June 30, 2019616,150,952  $6,162  (549,907) $(1,791) $3,061,631  $(20,351) $(1,336,720) $1,708,931  

The accompanying unaudited Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
For the six months ended June 30,
 20202019
Cash flows from operating activities:
Net loss$(25,429) $(140,568) 
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization44,318  47,477  
Non-cash interest5,022  2,868  
Amortization of deferred financing costs411  308  
Losses from investments in investees323  2,125  
Equity-based compensation – employees and non-employees4,037  7,579  
Realized loss on disposal of fixed assets and sales of equity securities156  220  
Change in fair value of equity securities and derivative instruments(6,515) 5,431  
Change in fair value of contingent consideration251  1,031  
Impairment of assets  655  
Deferred income tax provision1,028  168  
Changes in assets and liabilities:
Accounts receivable, net(81,539) (4,398) 
Inventory, net(21,905) (6,225) 
Other current assets and prepaid expenses(2,619) 2,476  
Other assets(61) 136  
Accounts payable(16,753) 12,887  
Foreign currency measurement(2,077) 131  
Contract liabilities(4,026) (37,015) 
Accrued expenses and other liabilities47,585  2,095  
Net cash used in operating activities(57,793) (102,619) 
Cash flows from investing activities:
Investments in investees  (1,200) 
Proceeds from the sale of property, plant and equipment65  309  
Capital expenditures(17,149) (6,432) 
Net cash used in investing activities(17,084) (7,323) 
Cash flows from financing activities:
Issuance of convertible notes, including to related parties  200,293  
Debt issuance costs  (7,762) 
Proceeds from the exercise of Common Stock options and warrants  (3) 
Borrowings on lines of credit393,651  39,695  
Repayments of lines of credit(382,374) (78,824) 
Redemption of 2033 Senior Notes  (28,800) 
Net cash provided by financing activities11,277  124,599  
Effect of exchange rate changes on cash and cash equivalents(240) (15) 
Net increase (decrease) in cash and cash equivalents(63,840) 14,642  
Cash and cash equivalents at beginning of period85,452  96,473  
Cash and cash equivalents at end of period$21,612  $111,115  
SUPPLEMENTAL INFORMATION:
Interest paid$5,578