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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 September 30, 2022.
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” in Rule 12b-2 of the Exchange Act:

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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 October 31, 2022, the registrant had 772,685,879 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, 2021, 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 coronavirus (COVID-19) pandemic, including the impact from potential declines in testing needs as infection rates decline;
we have had 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;
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;
that we may fail to obtain regulatory approval for Somatrogon (hGH-CTP) in the United States (“U.S.”) and other territories in which we have applied, or successfully commercialize hGH-CTP Somatrogon (hGH-CTP);
that we may not generate or sustain 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 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;
changes in regulation and policies in the 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 programs, suppliers and strategic partners;
efforts by third-party payors to reduce utilization and reimbursement for clinical testing services;

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our ability to maintain reimbursement coverage for our products and services, including Rayaldee and 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;
our ability to comply with the terms of our Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services;
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)
September 30, 2022December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents$180,838 $134,710 
Accounts receivable, net123,188 259,637 
Inventory, net71,429 86,502 
Other current assets and prepaid expenses38,516 27,170 
Assets held for sale 314,994 
Total current assets413,971 823,013 
Property, plant and equipment, net79,949 79,727 
Intangible assets, net835,136 321,683 
In-process research and development195,000 590,200 
Goodwill573,499 520,601 
Investments77,804 10,729 
Operating lease right-of-use assets39,790 44,228 
Other assets9,636 9,534 
Total assets$2,224,785 $2,399,715 
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable$49,748 $82,040 
Accrued expenses112,015 193,493 
Current maturities of operating leases11,535 11,624 
Current portion of convertible notes70,632  
Liabilities associated with assets held-for-sale 28,156 
Current portion of lines of credit and notes payable23,342 14,695 
Total current liabilities267,272 330,008 
Operating lease liabilities29,005 33,097 
Long term portion of convertible notes141,815 187,935 
Deferred tax liabilities135,073 148,487 
Other long-term liabilities, principally contract liabilities, contingent consideration and lines of credit22,552 15,062 
Total long-term liabilities328,445 384,581 
Total liabilities595,717 714,589 
Equity:
Common Stock - $0.01 par value, 1,000,000,000 shares authorized; 781,341,231 and 690,082,283 shares issued at September 30, 2022 and December 31, 2021, respectively
7,814 6,901 
Treasury Stock - 8,655,082 shares at September 30, 2022 and December 31, 2021, respectively
(1,791)(1,791)
Additional paid-in capital3,418,763 3,222,487 
Accumulated other comprehensive loss(58,026)(30,495)
Accumulated deficit(1,737,692)(1,511,976)
Total shareholders’ equity1,629,068 1,685,126 
Total liabilities and equity$2,224,785 $2,399,715 
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 September 30,For the nine months ended September 30,
 2022202120222021
Revenues:
Revenue from services$142,856 $340,163 $616,259 $1,244,312 
Revenue from products32,388 36,882 104,938 106,490 
Revenue from transfer of intellectual property and other4,500 8,768 97,659 22,585 
Total revenues179,744 385,813 818,856 1,373,387 
Costs and expenses:
Cost of service revenue128,182 223,193 521,221 830,428 
Cost of product revenue20,263 20,764 65,410 69,943 
Selling, general and administrative79,674 105,120 298,675 330,643 
Research and development18,792 18,306 54,359 55,843 
Contingent consideration(754)(497)(685)(1,556)
Amortization of intangible assets21,407 12,609 66,225 37,760 
Gain on sale of assets (31,508)(15,365)(31,508)
Total costs and expenses267,564 347,987 989,840 1,291,553 
Operating income (loss)(87,820)37,826 (170,984)81,834 
Other income and (expense), net:
Interest income667 9 838 21 
Interest expense(3,017)(4,290)(8,754)(14,572)
Fair value changes of derivative instruments, net446 1,283 652 571 
Other expense, net(36,651)(3,356)(111,091)(16,067)
Other expense, net(38,555)(6,354)(118,355)(30,047)
Income (loss) before income taxes and investment losses(126,375)31,472 (289,339)51,787 
Income tax benefit (provision)40,327 (2,680)46,524 (7,993)
Net income (loss) before investment losses(86,048)28,792 (242,815)43,794 
Loss from investments in investees(43)(53)(359)(163)
Net income (loss)$(86,091)$28,739 $(243,174)$43,631 
Income (loss) per share, basic and diluted:
Income (loss) per share$(0.11)$0.04 $(0.34)$0.07 
Weighted average common shares outstanding, basic and diluted750,396,263 651,843,074 708,121,980 646,710,240 

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 September 30,For the nine months ended September 30,
 2022202120222021
Net income (loss)$(86,091)$28,739 $(243,174)$43,631 
Other comprehensive loss, net of tax:
Change in foreign currency translation and other comprehensive loss(8,855)(9,991)(27,531)(15,698)
Comprehensive income (loss)$(94,946)$18,748 $(270,705)$27,933 

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 data)
For the three and nine months ended September 30, 2022

 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at June 30, 2022780,591,681 $7,806 (8,655,082)$(1,791)$3,413,556 $(49,171)$(1,651,601)$1,718,799 
Equity-based compensation expense— — — — 3,390 — — 3,390 
Exercise of common stock options and warrants27,750 1 — — (464)— — (463)
ModeX Acquisition721,800 7 — — 2,281 — — 2,288 
Net loss— — — — — — (86,091)(86,091)
Other comprehensive loss— — — — — (8,855)— (8,855)
Balance at September 30, 2022781,341,231 $7,814 (8,655,082)$(1,791)$3,418,763 $(58,026)$(1,737,692)$1,629,068 




 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive
Loss
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at December 31, 2021690,082,283 $6,901 (8,655,082)$(1,791)$3,222,487 $(30,495)$(1,511,976)$1,685,126 
Equity-based compensation expense— — — — 15,315 — — 15,315 
Exercise of common stock options and warrants629,837 7 — — (695)— — (688)
Adoption of ASU 2020-06— — — — (39,100)— 17,458 (21,642)
ModeX Acquisition90,629,111 906 — — 220,756 — — 221,662 
Net loss— — — — — — (243,174)(243,174)
Other comprehensive loss— — — — — (27,531)— (27,531)
Balance at September 30, 2022781,341,231 $7,814 (8,655,082)$(1,791)$3,418,763 $(58,026)$(1,737,692)$1,629,068 










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 data)
For the three and nine months ended September 30, 2021

 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive Income
(loss)
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at June 30, 2021689,817,971 $6,898 (8,655,082)$(1,791)$3,214,351 $(9,932)$(1,466,941)$1,742,585 
Equity-based compensation expense— — — — 3,822 — — 3,822 
Exercise of common stock options and warrants178,687 2 — — 410 — — 412 
Net income— — — — — — 28,739 28,739 
Other comprehensive loss— — — — — (9,991)— (9,991)
Balance at September 30, 2021689,996,658 $6,900 (8,655,082)$(1,791)$3,218,583 $(19,923)$(1,438,202)$1,765,567 




 Common StockTreasuryAdditional
Paid-In
Capital
Accumulated Other
Comprehensive Income
(loss)
Accumulated
Deficit
Total
 SharesDollarsSharesDollars
Balance at December 31, 2020670,585,576 $6,706 (549,907)$(1,791)$3,152,694 $(4,225)$(1,481,833)$1,671,551 
Equity-based compensation expense— — — — 9,929 — — 9,929 
Exercise of common stock options and warrants359,812 4 — — 875 — — 879 
2025 convertible notes19,051,270 190 (8,105,175)— 55,085 — — 55,275 
Net income— — — — — — 43,631 43,631 
Other comprehensive loss— — — — — (15,698)— (15,698)
Balance at September 30, 2021689,996,658 $6,900 (8,655,082)$(1,791)$3,218,583 $(19,923)$(1,438,202)$1,765,567 


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 nine months ended September 30,
 20222021
Cash flows from operating activities:
Net income (loss)$(243,174)$43,631 
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities:
Depreciation and amortization82,195 59,525 
Non-cash interest2,057 7,164 
Amortization of deferred financing costs863 603 
Losses from investments in investees359 163 
Equity-based compensation – employees and non-employees15,315 9,929 
Realized loss (gain) on disposal of fixed assets and sales of equity securities(814)(35,484)
Loss on conversion of the 2025 Notes 11,111 
Change in fair value of equity securities and derivative instruments104,126 1,919 
Change in fair value of contingent consideration(685)(1,556)
Gain on sale of GeneDx(15,365) 
Deferred income tax benefit(48,883)2,378 
Changes in assets and liabilities:
Accounts receivable, net130,052 27,934 
Inventory, net11,314 14,254 
Other current assets and prepaid expenses(3,977)(13,738)
Other assets211 1,015 
Accounts payable(25,000)(4,746)
Foreign currency measurement10,541 2,382 
Contract liabilities(73)(13,016)
Accrued expenses and other liabilities(82,631)(65,687)
Net cash (used in) provided by operating activities(63,569)43,980 
Cash flows from investing activities:
Proceeds from sale of investments 8,079 
Proceeds from sale of GeneDx115,423  
Acquisition of businesses, net of cash228 (4,000)
Proceeds from the sale of property, plant and equipment1,501 65,975 
Capital expenditures(18,242)(25,426)
Net cash provided by investing activities98,910 44,628 
Cash flows from financing activities:
Debt issuance costs (188)
Proceeds from the exercise of common stock options(688)879 
Borrowings on lines of credit893,548 1,326,641 
Repayments of lines of credit(880,033)(1,338,515)
Net cash provided by (used in) financing activities12,827 (11,183)
Effect of exchange rate changes on cash and cash equivalents(2,040)(163)
Net increase in cash and cash equivalents46,128 76,388 
Cash and cash equivalents at beginning of period134,710 72,211 
Cash and cash equivalents at end of period$180,838 $148,599 
SUPPLEMENTAL INFORMATION:
Interest paid$7,019 $8,386 
Income taxes paid, net of refunds$4,471 $5,509 
Non-cash financing:
Shares issued upon the conversion of:
2025 Convertible Notes
$ $68,775 
Common stock options and warrants, surrendered in net exercise$1,182 $ 
Issuance of common stock for acquisition of ModeX$221,662 $ 
Fair value of shares included in consideration from Sema4$172,000 $ 

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
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
NOTE 1 BUSINESS AND ORGANIZATION
We are a diversified healthcare company that seeks to establish industry-leading positions in large and rapidly growing medical markets. Our diagnostics business includes BioReference Health, LLC, formerly known as BioReference Laboratories, Inc. (“BioReference”), one of the nation’s largest full service laboratories with an 180-person sales and marketing team to drive growth and leverage new products. Our pharmaceutical business features Rayaldee, a U.S. Food and Drug Administration (“FDA”) approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency and a pipeline of products in various stages of development. Our leading product in development is Somatrogon (hGH-CTP), a once-weekly human growth hormone for which we have partnered with Pfizer, Inc. (“Pfizer”) and successfully completed a phase 3 study in August 2019. Regulatory applications for Somatrogon (hGH-CTP) have been submitted to the applicable regulatory bodies for review in several countries around the world. In February 2022, the European Commission granted marketing authorization in the European Union for Somatrogon (hGH-CTP) under the brand name NGENLA® to treat children and adolescents from as young as three years of age with growth disturbance due to insufficient secretion of growth hormone, and recently granted pricing approval in Germany. In January 2022, the Ministry of Health, Labour and Welfare in Japan approved NGENLA® (Somatrogon) for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone and we recently received pricing approval. In October 2021, Health Canada approved NGENLA® for the long-term treatment of pediatric patients who have growth hormone deficiency, and Australia’s Therapeutic Goods Administration approved NGENLA® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Pfizer submitted the initial Biologics License Application (“BLA”) with the FDA for approval of Somatrogon (hGH-CTP) in the United States and received a Complete Response Letter. Pfizer and OPKO are evaluating the FDA’s comments and will work with the agency to determine the best path forward for Somatrogon (hGH-CTP) in the United States. We are incorporated in Delaware, and our principal executive offices are located in leased offices in Miami, Florida.
Through BioReference, we provide laboratory testing services, primarily to customers in the larger metropolitan areas in New York, New Jersey, Florida, Texas, Maryland, California, Pennsylvania, Delaware, Washington, DC, Illinois and Massachusetts, as well as to customers in a number of other states. We offer a comprehensive test menu of clinical diagnostics for blood, urine and tissue analysis. This includes hematology, clinical chemistry, immunoassay, infectious diseases, serology, hormones, and toxicology assays, as well as Pap smear, anatomic pathology (biopsies) and other types of tissue analysis. We market our laboratory testing services directly to physicians, geneticists, hospitals, clinics, correctional and other health facilities.
We operate established pharmaceutical platforms in Ireland, Chile, Spain, and Mexico, which are generating revenue and from which we expect to generate positive cash flow and facilitate future market entry for our products currently in development. In addition, we have a development and commercial supply pharmaceutical company and a global supply chain operation and holding company in Ireland. We own a specialty active pharmaceutical ingredients (“APIs”) manufacturer in Israel, which we expect will facilitate the development of our pipeline of molecules and compounds for our proprietary molecular diagnostic and therapeutic products.
Our research and development activities are primarily performed at facilities in Woburn, MA, Waterford, Ireland, Kiryat Gat, Israel, and Barcelona, Spain.
On May 9, 2022 (the “Closing Date”), the Company entered into an Agreement and Plan of Merger (the “ModeX Merger Agreement”) with Orca Acquisition Sub, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), ModeX Therapeutics, Inc., a Delaware corporation (“ModeX”) and Gary J. Nabel, solely in his capacity as sellers’ representative, pursuant to which Merger Sub merged with and into ModeX (the “ModeX Merger”), with ModeX surviving the ModeX Merger as a wholly owned subsidiary of the Company. The Company paid the entirety of the $300.0 million purchase price pursuant to the issuance of an aggregate of 89,907,310 shares (the “Consideration Shares”) of the Company’s common stock, par value $0.01 per share (“Common Stock”), to the former stockholders of ModeX (the “Selling Stockholders”), of which 10% of such shares were deposited in a twelve-month escrow for purposes of satisfying the potential indemnity obligations of the Selling Stockholders under the ModeX Merger Agreement. Additionally, the Company issued equity awards to ModeX employees in an amount equal to $12.4 million, which was deducted from the consideration payable on the Closing Date. If any of such awards are forfeited or otherwise remain unvested on the four-year anniversary of the Closing Date, up to $2.6 million shares of Common Stock (valued at the same price used for determining the number of Consideration Shares issuable upon consummation of the ModeX Merger) may be distributed pro rata to ModeX’s former stockholders in respect of such forfeited or unvested awards. Shares of Common Stock with respect to such potential distribution have been escrowed and will remain escrowed for such four-year period. For accounting purposes, the shares were valued at $221.7 million, based on

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the closing price per share of our Common Stock of $2.44 as reported by NASDAQ Global Select Market (“NASDAQ”) on the Closing Date.
In connection with the ModeX Merger, the Company appointed Elias A. Zerhouni, M.D., Gary J. Nabel, M.D., PhD., and Alexis Borisy to the Board of Directors of the Company (the “Board”), with Dr. Zerhouni serving as Vice Chair. Elizabeth Nabel, one of the founders of ModeX, was appointed as the Company’s new Chief Medical Officer. Dr. Gary J. Nabel has been named the Chief Executive Officer of ModeX and Chief Innovation Officer of the Company and Dr. Elias A.Zerhouni has been named the President of the Company.
In accordance with the ModeX Merger Agreement, Dr. Phillip Frost, the Company’s Chief Executive Officer and Chairman of the Board, Dr. Jane Hsiao, the Company’s Chief Technical Officer and a Director, and Frost Gamma Investments Trust (“FGIT”), a trust controlled by Dr. Frost, entered into a lockup and voting agreement, together with the Company (the “ModeX Lockup and Voting Agreement”), pursuant to which: (i) FGIT has agreed that, for a period of four years immediately following the Closing Date, it will not sell or otherwise transfer its shares of Common Stock, subject to certain customary exceptions; and (ii) Drs. Frost and Hsiao agreed that, for as long as Dr. Elias A. Zerhouni or Dr. Gary J. Nabel remains an employee of the Company or ModeX, Drs. Frost and Hsiao will vote, or cause to be voted, all of their respective shares of Common Stock in favor of such person’s election to the Board. Additionally, in accordance with the ModeX Merger Agreement, certain recipients of the Consideration Shares, holding in aggregate approximately 88.0% of the Consideration Shares, agreed not to sell or otherwise transfer their respective Consideration Shares for a period of four years immediately following the Closing Date on the same terms as contained in the ModeX Lockup and Voting Agreement.
On January 14, 2022, the Company entered into an Agreement and Plan of Merger and Reorganization (the “GeneDx Merger Agreement”) with Sema4 Holdings Corp., a Delaware corporation (“Sema4”), pursuant to which Sema4 acquired the Company’s former subsidiary, GeneDx LLC, (f/k/a GeneDx, Inc. “GeneDx”), (the “GeneDx Transaction”) in a transaction that closed on April 29, 2022 (the “GeneDx Closing”).
Upon the GeneDx Closing, Sema4 paid to the Company aggregate consideration of $150 million in cash (before deduction of transaction expenses and other customary purchase price adjustments), together with 80.0 million shares (the “Closing Shares”) of Sema4’s Class A common stock, par value $0.0001 per share (“Sema4 Common Stock”). Additionally, Sema4 has agreed to pay the Company up to an additional $150 million, which may be paid in Sema4 Common Stock, cash or a combination thereof in Sema4’s discretion, subject to GeneDx achieving certain revenue targets for the fiscal years ending December 31, 2022 and 2023 (the “Milestone Consideration”). Based on the closing price of Sema4 Common Stock on April 29, 2022, the total upfront consideration was approximately $322 million, and the total aggregate consideration, including the potential Milestone Consideration, was approximately $447 million. We recognized a gain of $15.4 million on the sale of GeneDx during the second quarter of 2022.
In connection with the transactions contemplated by the GeneDx Merger Agreement, on January 14, 2022, the Company entered into a Shareholder Agreement (the “Sema4 Shareholder Agreement”) with Sema4, pursuant to which the Company has agreed to, among other things, be subject to a lock-up period with respect to its shares of Sema4 Common Stock, which expires on April 29, 2023 with respect to the Closing Shares, and, if earned and received, would extend for periods of one-year and six-months from the date of issuance of such shares in respect of the first and second potential Milestone Consideration payments, respectively.
Pursuant to the GeneDx Merger Agreement, the Company designated, and Sema4 nominated for election an individual to serve on the board of directors of Sema4, and such nominee was elected by Sema4’s stockholders to serve as a director until Sema4’s 2024 annual meeting of stockholders. In addition, the Company has further agreed to certain standstill provisions whereby, subject to certain exceptions, it is obligated to refrain from taking certain actions with respect to the Sema4 Common Stock. The Company has also agreed to vote its shares of Sema4 Common Stock in accordance with the recommendations of Sema4’s board of directors for so long as it continues to hold at least 5% of the outstanding shares of Sema4 Common Stock. Further, Sema4 has also granted the Company certain customary shelf, piggyback and demand registration rights that require Sema4 to register the shares of the Company’s shares of Sema4 Common Stock for resale under the Securities Act. OPKO does not intend to have a designee serving on Sema4’s board of directors upon the expiration of the lock-up period applicable to the Company’s shares of Sema4 Common Stock. Therefore, OPKO is not actively participating in the policy-making process of Sema4.
As of December 31, 2021, GeneDx met the held-for-sale accounting criteria and, its related assets and liabilities are classified as held for sale in the consolidated balance sheet. GeneDx was included in our diagnostics segment as of December 31, 2021.

NOTE 2 IMPACT OF COVID-19 AND FOREIGN EXCHANGE RATES

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Impact of COVID-19
We continue to be a part of the coordinated public and private sector response to SARS-CoV-2, a novel strain of coronavirus, referred to as COVID-19. There continues to be a high level of uncertainty relating to how the pandemic will evolve, how governments and consumers will react, and whether the pandemic will have a longer-term effect on the healthcare industry and patient habits. BioReference is providing COVID-19 solutions, including diagnostic molecular testing and serology antibody testing, to meet the testing needs of its customers, including physicians, health systems, long-term care facilities, governments, schools, employers, professional sports teams and entertainment venues, as well as the general public through relationships with retail pharmacy chains.
Throughout the pandemic, we have managed our company-wide lab operations specimen acquisition, logistics, procurement, customer service, and initiatives to manage our cost structure to match the ever changing COVID-19 testing volumes and to manage efficiency gains in our core clinical lines of business. We anticipate that COVID-19 will continue to impact our business in 2022 and, overall, we expect COVID-19 test demand to continue to decline in 2022 as compared to 2021.
Revenue from services for the nine months ended September 30, 2022 decreased by $628.1 million as compared to 2021 due to lower COVID-19 testing volumes. Excluding COVID-19 test volumes, for the nine months ended September 30, 2022, routine clinical test volume decreased 2.2% as compared to volumes for the nine months ended September 30, 2021.
In March 2022, the U.S. Health Resources and Services Administration ("HRSA") informed providers that, after March 22, 2022, it would stop accepting claims for testing and treatment for uninsured individuals under the HRSA COVID-19 Uninsured Program and that claims submitted prior to that date would be subject to eligibility and availability of funds. For the nine months ended September 30, 2022, revenue for testing of uninsured individuals under the HRSA COVID-19 Uninsured Program represented approximately 5.4% of our COVID-19 testing revenue.
Foreign Currency Exchange Rates
Approximately 22.0% of revenue for the nine months ended September 30, 2022, and approximately 7.3% of revenue for the nine months ended September 30, 2021, were denominated in currencies other than the U.S. Dollar (USD). Our financial statements are reported in USD and, accordingly, fluctuations in exchange rates will affect the translation of revenues and expenses denominated in foreign currencies into USD for purposes of reporting the consolidated financial results. In the third quarter of 2022 and the year ended December 31, 2021, the most significant currency exchange rate exposures were the Euro and Chilean Peso. Gross accumulated currency translation adjustments recorded as a separate component of shareholders’ equity were $54.6 million and $27.1 million at September 30, 2022 and December 2021, respectively.
We are subject to foreign currency transaction risk for fluctuations in exchange rates during the period of time between the consummation and cash settlement of transactions. We limit foreign currency transaction risk through hedge transactions with foreign currency forward contracts. Under these forward contracts, for any rate above or below the fixed rate, we receive or pay the difference between the spot rate and the fixed rate for the given amount at the settlement date. At September 30, 2022, we had 127 open foreign exchange forward contracts relating to inventory purchases on letters of credit with various amounts maturing monthly through October 2022 with a notional value totaling approximately $7.2 million. At December 31, 2021, we had 33 open foreign exchange forward contracts relating to inventory purchases on letters of credit with various amounts maturing monthly through January 2022 with a notional value totaling approximately $2.6 million.
NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation. The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of only normal recurring adjustments or adjustments otherwise disclosed herein) considered necessary to present fairly the Company’s results of operations, financial position and cash flows have been made. The results of operations and cash flows for the nine months ended September 30, 2022 are not necessarily indicative of the results of operations and cash flows that may be reported for the remainder of 2022 or any other future periods. The unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited Consolidated Financial Statements and the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2021.
Principles of consolidation. The accompanying unaudited Condensed Consolidated Financial Statements include the accounts of OPKO Health, Inc. and our wholly-owned subsidiaries. All intercompany accounts and transactions are eliminated in consolidation.
Use of estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and

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liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ significantly from these estimates.
Cash and cash equivalents. Cash and cash equivalents include short-term, interest-bearing instruments with original maturities of 90 days or less at the date of purchase. We also consider all highly liquid investments with original maturities at the date of purchase of 90 days or less as cash equivalents. These investments include money markets, bank deposits, certificates of deposit and U.S. treasury securities.
Inventories. Inventories are valued at the lower of cost and net realizable value. Cost is determined by the first-in, first-out method. We consider such factors as the amount of inventory on hand, estimated time required to sell such inventories, remaining shelf-life, and current market conditions to determine whether inventories are stated at the lower of cost and net realizable value. Inventories at our diagnostics segment consist primarily of purchased laboratory supplies, which are used in our testing laboratories. Inventory obsolescence expense for the three and nine months ended September 30, 2022 was $3.0 million and $4.0 million, respectively. Inventory obsolescence expense for the three and nine months ended September 30, 2021 was $1.3 million and $5.3 million, respectively.
Goodwill and intangible assets. Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired accounted for by the acquisition method of accounting. Refer to Note 5. Goodwill, in-process research and development (“IPR&D”) and other intangible assets acquired in business combinations, licensing and other transactions was $1.6 billion and $1.4 billion, respectively, at September 30, 2022 and December 31, 2021.
Assets acquired and liabilities assumed in business combinations, licensing and other transactions are generally recognized at the date of acquisition at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. At acquisition, we generally determine the fair value of intangible assets, including IPR&D, using the “income method.”
Subsequent to their acquisition, goodwill and indefinite lived intangible assets are tested at least annually as of October 1 for impairment, or when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable.
Estimating the fair value of a reporting unit for goodwill impairment is highly sensitive to changes in projections and assumptions and changes in assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Ultimately, potential changes in these assumptions may impact the estimated fair value of a reporting unit and result in an impairment if the fair value of such reporting unit is less than its carrying value. Goodwill was $573.5 million and $520.6 million, respectively, at September 30, 2022 and December 31, 2021. At December 31, 2021, Assets held for sale include $151.8 million of goodwill related to GeneDx.
Net intangible assets other than goodwill was $1.0 billion and $0.9 billion on September 30, 2022 and December 31, 2021, respectively, including IPR&D of $195.0 million on September 30, 2022 and $590.2 million on December 31, 2021. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products and IPR&D. Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges may occur in future periods. Estimating the fair value of IPR&D for potential impairment is highly sensitive to changes in projections and assumptions and changes in assumptions could potentially lead to impairment.
Upon obtaining regulatory approval, IPR&D assets are then accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life. If the project is abandoned, the IPR&D asset is charged to expense. Finite lived intangible assets are tested for impairment when events or changes in circumstances indicate it is more likely than not that the carrying amount of such assets may not be recoverable. The testing includes a comparison of the carrying amount of the asset to its estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset.
We believe that our estimates and assumptions in testing goodwill and other intangible assets, including IPR&D, for impairment are reasonable and otherwise consistent with assumptions that marketplace participants would use in their estimates of fair value. Based on the current financial performance of our diagnostic segment, if future results are not consistent with our estimates and assumptions, then we may be exposed to impairment charges, which could be material. In our pharmaceutical segment, Pfizer submitted the initial BLA with the FDA for approval of Somatrogon (hGH-CTP) in the United States, and Pfizer received a Complete Response Letter in January 2022. Pfizer and OPKO are evaluating the FDA’s comments and will work with the agency to determine the best path forward for Somatrogon (hGH-CTP) in the United States. If we are unable to

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get approval for Somatrogon (hGH-CTP) in the United States, then we may be exposed to impairment charges, which could be material.
In the first quarter of 2022, we reclassified $590.2 million of IPR&D related to Somatrogon (hGH-CTP) from IPR&D in our Condensed Consolidated Balance Sheet upon the approval of NGENLA (Somatrogon) in Europe and Japan. The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.
We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 3 to 20 years. We use the straight-line method of amortization as there is no reliably determinable pattern in which the economic benefits of our intangible assets are consumed or otherwise used up. Amortization expense was $66.2 million and $37.8 million for the nine months ended September 30, 2022 and 2021, respectively.
Fair value measurements. The carrying amounts of our cash and cash equivalents, accounts receivable, accounts payable and short-term debt approximate their fair value due to the short-term maturities of these instruments. Investments that are considered equity securities as of September 30, 2022 and December 31, 2021 are predominately carried at fair value. Our debt under the Credit Agreement (as defined below) approximates fair value due to the variable rate of interest applicable to such debt.
In evaluating the fair value information, considerable judgment is required to interpret the market data used to develop the estimates. The use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts. Accordingly, the estimates of fair value presented herein may not be indicative of the amounts that could be realized in a current market exchange. Refer to Note 9.
Contingent consideration. Each period we revalue the contingent consideration obligations associated with certain prior acquisitions to their fair value and record increases in the fair value as contingent consideration expense and decreases in the fair value as a reduction in contingent consideration expense. Changes in contingent consideration result from changes in the assumptions regarding probabilities of successful achievement of related milestones, the estimated timing in which the milestones are achieved and the discount rate used to estimate the fair value of the liability. Contingent consideration may change significantly as our development programs progress, revenue estimates evolve and additional data is obtained, impacting our assumptions. The assumptions used in estimating fair value require significant judgment. The use of different assumptions and judgments could result in a materially different estimate of fair value which may have a material impact on our results from operations and financial position.
Derivative financial instruments. We record derivative financial instruments on our Condensed Consolidated Balance Sheet at their fair value and recognize the changes in the fair value in our Condensed Consolidated Statement of Operations when they occur, the only exception being derivatives that qualify as hedges. For the derivative instrument to qualify as a hedge, we are required to meet strict hedge effectiveness and contemporaneous documentation requirements at the initiation of the hedge and assess the hedge effectiveness on an ongoing basis over the life of the hedge. At September 30, 2022 and December 31, 2021, our foreign currency forward contracts held to economically hedge inventory purchases did not meet the documentation requirements to be designated as hedges. Accordingly, we recognized all changes in the fair values of our derivatives instruments, net, in our Condensed Consolidated Statement of Operations. Refer to Note 10.
Property, plant and equipment. Property, plant and equipment are recorded at cost or fair value if acquired in a business combination. Depreciation is provided using the straight-line method over the estimated useful lives of the assets and includes amortization expense for assets capitalized under finance leases. The estimated useful lives by asset class are as follows: software - 3 years, machinery, medical and other equipment - 5-8 years, furniture and fixtures - 5-12 years, leasehold improvements - the lesser of their useful life or the lease term, buildings and improvements - 10-40 years, and automobiles - 3-5 years. Expenditures for repairs and maintenance are charged to expense as incurred. Assets held under finance leases are included within Property, plant and equipment, net in our Consolidated Balance Sheets and are amortized over the shorter of their useful lives or the expected term of their related leases. Depreciation expense was $5.0 million and $16.0 million for the three and nine months ended September 30, 2022, respectively. Depreciation expense was $6.4 million and $21.8 million for three and nine months ended September 30, 2021, respectively.
Impairment of long-lived assets. Long-lived assets, such as property and equipment and assets held for sale, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset.
Income taxes. Income taxes are accounted for under the asset-and-liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of

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existing assets and liabilities and the respective tax bases and for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. We periodically evaluate the realizability of our net deferred tax assets. Our tax accruals are analyzed periodically and adjustments are made as events occur to warrant such adjustment. Valuation allowances on certain U.S. deferred tax assets and non-U.S. deferred tax assets are established, because realization of these tax benefits through future taxable income does not meet the more-likely-than-not threshold.
We operate in various countries and tax jurisdictions globally.  For interim reporting purposes, we record income taxes based on the expected effective income tax rate, taking into consideration year to date and global forecasted tax results.  For the nine months ended September 30, 2022, the tax rate differed from the U.S. federal statutory rate of 21% primarily due to the valuation allowance against certain U.S. and non-U.S. deferred tax assets, the relative mix in earnings and losses in the U.S. versus foreign tax jurisdictions, and the impact of certain discrete tax events and operating results in tax jurisdictions which do not result in a tax benefit.
Revenue recognition. We recognize revenue when a customer obtains control of promised goods or services in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“Topic 606”). The amount of revenue that is recorded reflects the consideration that we expect to receive in exchange for those goods or services. We apply the following five-step model in order to determine this amount: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation.
We apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, we review the contract to determine which performance obligations we must deliver and which of these performance obligations are distinct. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. For a complete discussion of accounting for Revenues from services, Revenues from products and Revenue from transfer of intellectual property and other, refer to Note 13.
Concentration of credit risk and allowance for credit losses. Financial instruments that potentially subject us to concentrations of credit risk consist primarily of accounts receivable. Substantially all of our accounts receivable are with either companies in the healthcare industry or patients. However, credit risk is limited due to the number of our clients as well as their dispersion across many different geographic regions.
While we have receivables due from federal and state governmental agencies, we do not believe that such receivables represent a credit risk because the related healthcare programs are funded by federal and state governments, and payment is primarily dependent upon submitting appropriate documentation. On September 30, 2022 and December 31, 2021, receivable balances (net of explicit and implicit price concessions) from Medicare and Medicaid were 14% and 6%, respectively, of our consolidated Accounts receivable, net. On September 30, 2022 and December 31, 2021, receivable balances (net of explicit and implicit price concessions) due directly from states, cities and other municipalities, specifically related to our real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay to detect COVID-19, were 2.7% and 4.1% of our consolidated accounts receivable, net, respectively.
The portion of our accounts receivable due from individual patients comprises the largest portion of credit risk. At September 30, 2022 and December 31, 2021, receivables due from patients represented approximately 2.8% and 0.7%, respectively, of our consolidated Accounts receivable, net.
We assess the collectability of accounts receivable balances by considering factors such as historical collection experience, customer credit worthiness, the age of accounts receivable balanc