What changed in this filing

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Item 9A. Controls and Procedures

2023-02-27 compared with 2022-03-01 · 117 added, 108 removed, 272 unchanged (45% of the section changed)

10 unchanged sentences

Therefore, even those systems determined effective could provide only reasonable assurance with respect to financial statement preparation and presentation.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2021, based on the framework in the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “2013 Internal Control-Integrated Framework”).

Based on our evaluation under the 2013 Internal Control-Integrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2021.

The effectiveness of the Company’s internal control over financial reporting as of December 31, 2021 has been audited by Ernst & Young LLP, our independent registered public accounting firm, who also audited our Consolidated Financial Statements included in this Annual Report on Form 10-K, as stated in their report which appears with our accompanying Consolidated Financial Statements.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2022, based on the framework in the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission .

Based on such evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2022.

The effectiveness of the Company’s internal control over financial reporting as of December 31, 2022 has been audited by Ernst & Young LLP, our independent registered public accounting firm, which also audited our Consolidated Financial Statements included in this Annual Report on Form 10-K, as stated in their report which appears with our accompanying Consolidated Financial Statements.

Changes to the Company’s Internal Control Over Financial Reporting

14 unchanged sentences

Number Description

Underwriting Agreement, dated October 24, 2019, by and among OPKO Health, Inc., Jeffries LLC, Piper Jaffray & Co., and Guggenheim Securities, LLC as representatives of underwriters named therein.

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.

Underwriting Agreement, dated October 24, 2019, by and among OPKO Health, Inc., Jeffries LLC, Piper Jaffray & Co., and Guggenheim Securities, LLC as representatives of underwriters named therein , filed with the Company ’ s Current Report on Form 8-K filed wit h the Securities and Exchange Commission on October 29 , 2019 , and incorporated here in by reference .

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 , filed with the Company ’ s Quarterly Report on Form 10-Q/A filed with t he Securities and Exchange Commission on Jul y 2 5, 2011, and inco r porated herein by reference .

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 , filed with the Company’s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on Novembe r 9, 20 12 for the Company’s three-month period ended September 30, 2012, and incorporated herein by reference .

Agreement and Plan of Merger and Reorganization, dated as of January 14, 2022, by and among the Company, Sema4 Holdings Corp., Orion Merger Sub I, Inc., Orion Merger Sub II, LLC, GeneDx Inc.

and GeneDx Holding 2, Inc.

Amended and Restated Certificate of Incorporation, as amended.

Amended and Restated Bylaws.

Certificate of Designation of Series D Preferred Stock.

Amendment to Amended and Restated Certificate of Incorporation

Form of Common Stock Warrant.

, filed with the Company’s Current Report on Form 8- K filed with the Securities and Exchange Commission on January 18, 2022 , and incorporated herein by reference .

A greement and Plan of Merger, dated as of May 9, 2022, by and among the Company, ModeX Therapeutics, Inc., Orca Acquisition Sub, Inc.

Nabel, solely in the capacity of a representative of the Stockholders , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on May 13, 2022, and incorporated herein by reference.

Amended and Restated Certificate of Incorporation, as amended , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on November 12 , 201 3 for the Company’s three-month period ended September 30, 201 3 , and incorporated herein by reference .

Amended and Restated Bylaws , filed with the Company’s Annual Report on Form 10⁃ K filed with the Securities and Exchange Commission on Februar y 18 , 20 2 1 , and incorporated herein by reference .

Certificate of Designation of Series D Preferred Stock , filed with the Company’s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on September 24 , 20 09 , and incorporated herein by reference .

Amendment to Amended and Restated Certificate of Incorporation , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on June 2 1 , 20 1 9, and incorporated herein by reference .

Form of Common Stock Warrant , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on April 2 , 200 7 , and incorporated herein by reference .

Form of Common Stock Warrant , 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 .

Indenture, dated January 30, 2013, between OPKO Health, Inc.

and Wells Fargo Bank, National Association.

and Wells Fargo Bank, National Association , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on February 5 , 20 13 , and incorporated herein by reference .

Base Indenture related to the 4.50% Convertible Senior Notes due 2025, dated as of February 7, 2019, by and between OPKO Health, Inc.

Bank National Association, as trustee.

Bank National Association, as trustee , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on February 7 , 201 9 , and incorporated herein by reference .

Supplemental Indenture related to the 4.50% Convertible Senior Notes due 2025, dated as of February 7, 2019, by and between OPKO Health, Inc.

Bank National Association, as trustee.

Description of Securities

Form of Director Indemnification Agreement.

Form of Officer Indemnification Agreement.

Form of Restricted Share Award Agreement for Directors.

1 0.4 ( 7 ) +

Description of Securities , filed with the Company’s Annual Report on Form 10⁃K filed with the Securities and Exchange Commission on Februar y 18 , 2021, and incorporated herein by reference .

Form of Director Indemnification Agreement , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on August 8 , 20 08 for the Company’s three-month period ended June 30, 20 08 , and incorporated herein by reference .

Form of Officer Indemnification Agreement , 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 .

Form of Restricted Share Award Agreement for Directors , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on N ovember 9 , 200 9 for the Company’s three-month period ended September 30, 200 9 , and incorporated herein by reference .

Exclusive License Agreement by and between TESARO, Inc.

and OPKO Health, Inc.

dated December 10, 2010.

dated December 10, 2010 , filed with the Company’s Quarterly Report on Form 10- K /A filed with the Securities and Exchange Commission on Jul y 28 , 2011, and inco r porated herein by reference .

OPKO Health, Inc.

2016 Equity Incentive Plan.

2016 Equity Incentive Plan , filed with the Company’s Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on Marc h 25 , 201 6 , and incorporated herein by reference .

Development and License Agreement between OPKO Health, Inc.

and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 8, 2016.

Form of 5% Convertible Promissory Note dated February 27, 2018.

and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 8, 2016 , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on August 8 , 20 16 for the Company’s three-month period ende d June 30, 20 16 , and incorporated herein by reference .

Form of 5% Convertible Promissory Note dated February 27, 2018 , filed with the Company’s Annual Report on Form 10⁃K filed with the Securities and Exchange Commission on March 1 , 20 1 8 , and incorporated herein by reference .

Share Lending Agreement, dated February 4, 2019, by and between the OPKO Health, Inc.

and Jefferies Capital Services, LLC.

and Jefferies Capital Services, LLC , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on February 7, 2019, and incorporated herein by reference .

Amendment to Development and License Agreement between EirGen Pharma Ltd.

and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 5, 2020.

and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 5, 2020 , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on July 31, 2020 for the Company’s three-month period ende d June 30, 20 20 , and incorporated herein by reference .

Amended and Restated Development and Commercialization License Agreement by and between Pfizer Inc.

and OPKO Ireland Ltd., dated May 12, 2020.

and OPKO Ireland Ltd., dated May 12, 2020 , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on July 31, 2020 for the Company’s three-month period ende d June 30, 2020, and incorporated herein by reference .

Form of Exchange Agreement, dated as of May 6, 2021, by and between OPKO Health Inc.

and the applicable Noteholder.

and the applicable Noteholder , filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on May 7, 20 2 1 , and incorporated herein by reference .

Asset Purchase Agreement, dated June 16, 2021, among EirGen Pharma Limited, Horizon Therapeutics Ireland DAC, and OPKO Health, Inc.

(with respect to certain sections).

License Agreement by and among EirGen Pharma Limited and Nicoya Macua Limited, dated June 18, 2021.

Exclusive License Agreement , dat ed July 6, 2021, by and between OPKO Health, Inc.

and CAMP4 Therapeutics Corporation .

(with respect to certain sections) , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on July 29 , 202 1 for the Company’s three-month period ende d June 30, 202 1 , and incorporated herein by reference .

License Agreement by and among EirGen Pharma Limited and Nicoya Macua Limited, dated June 18, 2021 , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on July 29, 2021 for the Company’s three-month period ende d June 30, 2021, and incorporated herein by reference .

Exclusive License Agreement, dated July 6, 2021, by and between OPKO Health, Inc.

and CAMP4 Therapeutics Corporation , filed with the Company’s Quarterly Report on Form 10⁃Q filed with the Securities and Exchange Commission on July 29, 2021 for the Company’s three-month period ende d June 30, 2021, and incorporated herein by reference .

Amended and Restated Credit Agreement, dated August 30, 2021, by and among by and among BioReference Laboratories, Inc., certain of its subsidiaries, and JPMorgan Chase Bank, N.A.

, filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on Septemb er 3 , 2021, and incorporated herein by reference .

Shareholder Agreement, dated January 14, 2022, by and between OPKO Health, Inc.

and SEMA4 Holdings Corp.

, filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on Januar y 18 , 202 2 , and incorporated herein by reference .

Lock-up and Voting Agreement, dated as of May 9, 2022, by and among the Company, Dr.

Phillip Frost, Dr.

Jane Hsiao and Frost Gamma Investments Trust.

Offer Letter, dated May 9, 2022, by and between the Company and Dr.

Offer Letter, dated May 9.

2022, by and between the Company and Dr.

Waiver Under and Amendment No.

1 to Amended and Restated Credit Agreement between BioReference Health, LLC, GeneDx, LLC, the other Subsidiary Borrowers party hereto, the other Loan Parties party hereto, the Lenders party hereto, and JPMorgan Chase Bank, N.A., as the administrative agent for the Lenders, dated April 29, 2022, filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on May 4, 2022, and incorporated herein by reference.

Settlement Agreement between United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services, and the Defense Health Agency, acting on behalf of the TRICARE Program, the Commonwealth of Massachusetts, acting through the Medicaid Fraud Division of the Office of Attorney General and on behalf of the Executive Office of Health and Human Services, limited to its role as the single state agency for Medicaid, the State of Connecticut, acting through the Attorney General of the State of Connecticut, BioReference Health, LLC and OPKO Health, Inc., and Jean Marie Crowley, effective July 14, 2022, filed with the Company’s Current Report on Form 8⁃K filed with the Securities and Exchange Commission on July 15, 2022, and incorporated herein by reference.

Form of Amended 5% Convertible Promissory Note dated February 10, 2023.

Subsidiaries of the Company.

14 unchanged sentences

+ 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 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.

(3) 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.

(4) 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.

(5) 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.

(6) 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.

(7) Filed with the Company’s Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on July 28, 2011.

(8) 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.

(9) 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.

(10) 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.

(11) 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.

(12) Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2018 and incorporated herein by reference.

(13) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 7, 2019 and incorporated herein by reference.

(14) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 21, 2019.

(15) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2019.

(16) Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on July 31, 2020.

(17) Filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 18, 2021 and incorporated herein by reference.

(18) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 7, 2021.

(19) Filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on July 29, 2021.

(20) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 3, 2021

(21) Filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 18, 2022.

FORM 10-K SUMMARY.

16 unchanged sentences

Current maturities of operating leases 1,225 1,203

Liabilities associated with assets held for sale — —

Current portion of convertible notes 3,050 —

Current portion of notes payable 2,615 2,615

7 unchanged sentences

781,306,164 and 690,082,283 shares issued at December 31, 2022 and 2021, respectively

Treasury Stock, at cost - 8,655,082 and 549,907 shares at December 31, 2021 and 2020, respectively (1,791) (1,791)

Treasury Stock, at cost - 8,655,082 shares at December 31, 2022 and 2021, respectively

( 1,791 ) ( 1,791 )

Additional paid-in capital 3,421,872 3,222,487

16 unchanged sentences

Research and development 4,196 2,029 1,951

Gain on sale of GeneDx ( 18,559 ) — —

Total costs and expenses 34,866 69,791 43,947

8 unchanged sentences

Income tax provision ( 10 ) ( 2 ) ( 175 )

Net loss before investment losses (99,827) (55,363) (77,891)

Net loss before investments and loss from subsidiaries ( 201,597 ) ( 99,827 ) ( 55,363 )

Loss from investments in investees ( 383 ) ( 629 ) ( 480 )

20 unchanged sentences

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Depreciation and amortization — — 59

Non-cash interest 2,750 9,389 9,994

5 unchanged sentences

Realized gain on equity securities and disposal of fixed assets — ( 2,981 ) ( 10,324 )

Change in fair value of derivative instruments 4,871 (6) 9,523

Change in fair value of derivative instruments and equity securities 154,473 4,871 ( 6 )

Loss on conversion of the 2025 Notes — 11,111 —

Adoption of ASC 326 and other — — ( 1,311 )

Gain on sale of GeneDx ( 18,559 ) — —

Changes in other assets and liabilities ( 14,993 ) 10,970 ( 243 )

4 unchanged sentences

Proceeds from sale of equity securities 115,423 8,078 15,110

Net cash provided by (used in) investing activities 75,686 (8,124) (153,576)

Net cash (used in) provided by investing activities 139,289 75,686 ( 8,124 )

Cash flows from financing activities:

Issuance convertible notes, net — — 200,293

Issuance of common stock — — 76,061

Debt issuance costs — — (7,762)

Proceeds from the exercise of Common Stock options and warrants ( 774 ) 1,080 756

Borrowings on lines of credit — — 28,800

Repayments of lines of credit — — (28,800)

Redemption of 2033 Senior Notes — — (28,800)

Net cash provided by financing activities 1,080 756 239,789

Net cash (used in) provided by financing activities ( 774 ) 1,080 756

Net increase (decrease) in cash and cash equivalents 80,191 20,852 ( 54,887 )

4 unchanged sentences

Income taxes paid, net of refunds $ 8,037 $ 5,969 $ ( 903 )

Operating lease right-of-use assets due to adoption of ASU No.

2016-02 $ — $ — $ 4,855

Operating lease liabilities due to adoption of ASU No.

2016-02 $ — $ — $ 4,855

Non-cash financing:

1 unchanged sentence

Common Stock options and warrants, surrendered in net exercise $ 1,268 $ — $ —

Issuance of common stock for acquisition of ModeX $ 221,662 $ — $ —

Fair value of shares included in consideration from GeneDx Holdings $ 172,000 $ — $ —

The accompanying Notes to Parent Company Condensed Financial Statements are an integral part of these statements.

7 unchanged sentences

The Parent Company Condensed Financial Statements included herein have been prepared in accordance with Rule 12-04, Schedule I of Regulation S-X, as substantially all the assets of BioReference, a wholly-owned subsidiary, and its subsidiaries are restricted from sale, transfer, lease, disposal or distributions to OPKO under the A&R Credit Agreement (as defined below), subject to certain exceptions.

BioReference and its subsidiaries’ net assets as of December 31, 2021 were approximately $1.1 billion, which includes goodwill of $283.0 million and intangible assets of $204.4 million.

BioReference and its subsidiaries’ net assets as of December 31, 2022 were approximately $ 608.6 million, which includes goodwill of $ 283.0 million and intangible assets of $ 187.9 million.

BioReference’s restricted net assets exceeds 25 % of OPKO’s consolidated net assets of $ 1.6 billion as of December 31, 2022.

On February 25, 2020, we entered into a credit agreement with an affiliate of Dr.

Frost, pursuant to which the lender committed to provide us with an unsecured line of credit in the amount of $100 million.

The line of credit called for a commitment fee equal to 0.25% per annum of the unused portion of the line.

We terminated this line of credit in June 2021 and as of December 31, 2021, no amount was outstanding thereunder.

In February 2019, we issued $ 200.0 million aggregate principal amount of Senior Convertible Notes due 2025 (the “2025 Notes”) in an underwritten public offering.

12 unchanged sentences

We may not redeem the 2025 Notes prior to February 15, 2022.

preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

We may redeem for cash any or all of the notes, at our option, on or after February 15, 2022, if the last reported sale price of our Common Stock has been at least 130 % of the then current conversion price for the notes for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100 % of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

No sinking fund is provided for the 2025 Notes.

If we undergo a fundamental change, as defined in the indenture governing the 2025 Notes, prior to the maturity date of the 2025 Notes, holders may require us to repurchase for cash all or any portion of their notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

100 % of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The 2025 Notes are our senior unsecured obligations and rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the 2025 Notes;

3 unchanged sentences

In May 2021, we entered into exchange agreements with certain holders of the 2025 Notes pursuant to which the holders exchanged $ 55.4 million in aggregate principal amount of the outstanding 2025 Notes for 19,051,270 shares of our Common Stock (the “Exchange”).

We recorded an $11.1 million non-cash loss related to the Exchange.

We recorded an $ 11.1 million non-cash loss related to the Exchange during 2021.

In conjunction with the issuance of the 2025 Notes, we agreed to loan up to 30,000,000 shares of our Common Stock to affiliates of the underwriter in order to assist investors in the 2025 Notes to hedge their position.

Following consummation of the Exchange, the number of outstanding borrowed shares of Common Stock was reduced by approximately 8,105,175 shares.

As of December 31, 2021 and 2020, a total of 21,144,825 and 29,250,000 shares were issued under the share lending arrangement, respectively.

Following consummation of the Exchange, the number of outstanding borrowed shares of Common Stock was reduced by 8,105,175 shares.

As of December 31, 2022 and 2021, a total of 21,144,825 and 21,144,825 shares remained outstanding under the share lending arrangement, respectively.

We will not receive any of the proceeds from the sale of the borrowed shares, but we received a one-time nominal fee of $ 0.3 million for the newly issued shares.

Shares of our Common Stock outstanding under the share lending arrangement are excluded from the calculation of basic and diluted earnings per share.

As required by ASC 470-20, “Debt with Conversion and Other Options,” we calculated the equity component of the 2025 Notes, taking into account both the fair value of the conversion option and the fair value of the share lending arrangement.

The equity component was valued at $52.6 million at issue date and this amount was recorded as Additional paid-in capital, which resulted in a discount on the 2025 Notes.

The discount is being amortized to Interest expense over the term of the 2025 Notes, which results in an effective interest rate on the 2025 Notes of 11.2%.

The following table sets forth information related to the 2025 Notes which is included in our Consolidated Balance Sheet as of December 31, 2022:

2 unchanged sentences

Amortization of debt discount and debt issuance costs — — 1,094 1,094

Conversion (55,420) 10,151 1,104 (44,165)

Adoption of ASU 2020-06 — 22,747 ( 1,105 ) 21,642

Balance at December 31, 2022 $ 144,580 $ — $ ( 2,484 ) $ 142,096

In August 2020, the FASB issued ASU No.

2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40).” ASU 2020-06 simplifies the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock.

The ASU is effective for public entities for fiscal years beginning after December 15, 2021, with early adoption permitted.

As required, we adopted ASU 2020-06 on January 1, 2022 and used the modified retrospective approach for all convertible debt instruments at the beginning of the period of adoptions.

Results for reporting periods beginning January 1, 2022 are presented under ASU 2020-06, while prior period amounts were not adjusted and continue to be reported in accordance with historic accounting guidance.

Under the modified approach, entities applied the guidance to all financial instruments that are outstanding as of the beginning of the year of adoption with the cumulative effect recognized as an adjustment to the opening balance of retained earnings.

ASU 2020-06 eliminates the cash conversion and beneficial conversion feature models in ASC 470-20 that require an issuer of certain convertible debt and preferred stock to separately account for embedded conversion features as a component of equity.

The adoption of ASU 2020-06 at January 1, 2022 resulted in an increase of the 2025 Convertible notes of $ 21.6 million, a reduction of the Accumulated deficit of $ 17.5 million and a reduction of Additional paid-in capital of $ 39.1 million.

In February 2018, we issued a series of 5 % Convertible Promissory Notes (the “2023 Convertible Notes”) in the aggregate principal amount of $ 55.0 million.

The 2023 Convertible Notes mature 5 years from the date of issuance.

Each holder of a 2023 Convertible Note has the option, from time to time, to convert all or any portion of the outstanding principal balance of such 2023 Convertible Note, together with accrued and unpaid interest thereon, into shares of our Common Stock at a conversion price of $5.00 per share of Common Stock.

We may redeem all or any part of the then issued and outstanding 2023 Convertible Notes, together with accrued and unpaid interest thereon, pro rata among the holders, upon no fewer than 30 days, and no more than 60 days, notice to the holders.

4 unchanged sentences

In January 2013, we entered into note purchase agreements with respect to the issuance and sale of our 3.0 % Senior Notes due 2033 (the “2033 Senior Notes”) in a private placement exempt from registration under the Securities Act.

We issued the 2033 Senior Notes on January 30, 2013.

We issued the

2033 Senior Notes on January 30, 2013.

The 2033 Senior Notes, which totaled $ 175.0 million in original principal amount, bear interest at the rate of 3.0 % per year, payable semiannually on February 1 and August 1 of each year.

The 2033 Senior Notes mature on February 1, 2033, unless earlier repurchased, redeemed or converted.

Upon a fundamental change as defined in the indenture, governing the 2033 Senior Notes, subject to certain exceptions, the holders may require us to repurchase all or

any portion of their 2033 Senior Notes for cash at a repurchase price equal to 100% of the principal amount of the 2033 Senior Notes being repurchased, plus any accrued and unpaid interest to but not including the related fundamental change repurchase date.

Upon a fundamental change as defined in the indenture, governing the 2033 Senior Notes, subject to certain exceptions, the holders may require us to repurchase all or any portion of their 2033 Senior Notes for cash at a repurchase price equal to 100 % of the principal amount of the 2033 Senior Notes being repurchased, plus any accrued and unpaid interest to but not including the related fundamental change repurchase date.

From 2013 to 2016, holders of the 2033 Senior Notes converted $ 143.2 million in aggregate principal amount into an aggregate of 21,539,873 shares of Common Stock.

13 unchanged sentences

(“CB”), as lender and administrative agent (as amended the “Credit Agreement”).

The Credit Agreement provides for a $75.0 million secured revolving credit facility and includes a $20.0 million sub-facility for swingline loans and a $20.0 million sub-facility for the issuance of letters of credit.

On August 30, 2021, the Credit Agreement was amended and restated (the “A&R Credit Agreement”).

The A&R Credit Agreement is guaranteed by all of BioReference’s domestic subsidiaries.

The A&R Credit Agreement is also secured by substantially all assets of BioReference and its domestic subsidiaries, as well as a non-recourse pledge by us of our equity interest in BioReference.

Availability under the A&R Credit Agreement is based on a borrowing base composed of eligible accounts receivables of BioReference and certain of its subsidiaries, as specified therein.

As amended, the Credit Agreement provides for a $ 75.0 million secured revolving credit facility and includes a $ 20.0 million sub-facility for swingline loans and a $ 20.0 million sub-facility for the issuance of letters of credit.

The Credit Agreement is guaranteed by all of BioReference’s domestic subsidiaries and is also secured by substantially all assets of BioReference and its domestic subsidiaries, as well as a non-recourse pledge by us of our equity interest in BioReference.

Availability under the Credit Agreement is based on a borrowing base composed of eligible accounts receivables of BioReference and certain of its subsidiaries, as specified therein.

As of December 31, 2022, $ 16.8 million remained available for borrowing under the Credit Agreement.

Principal under the Credit Agreement is due upon maturity on August 30, 2024.

At BioReference’s option, borrowings under the Credit Agreement (other than swingline loans) bear interest at (i) the CB floating rate (defined as the higher of (a) the prime rate and (b) the LIBOR rate (adjusted for statutory reserve requirements for Eurocurrency liabilities) for an interest period of one month plus 2.50 %) plus an applicable margin of 0.75 % or (ii) the LIBOR rate (adjusted for statutory reserve requirements for Eurocurrency liabilities) plus an applicable margin of 1.75 %.

Swingline loans will bear interest at the CB floating rate plus the applicable margin.

The Credit Agreement also calls for other customary fees and charges, including an unused commitment fee of 0.375 % if the average quarterly availability is 50% or more of the revolving commitment, or 0.25 % if the average quarterly availability is less than or equal to 50% of the revolving commitments.

As of December 31, 2022 and 2021, $ 18.1 million amount and no amount, respectively, was outstanding under the Credit Agreement.

The Credit Agreement contains customary covenants and restrictions, including, without limitation, covenants that require BioReference and its subsidiaries to maintain a minimum fixed charge coverage ratio if availability under the new credit facility falls below a specified amount and to comply with laws and restrictions on the ability of BioReference and its subsidiaries to incur additional indebtedness or to pay dividends and make certain other distributions to the Company, subject to certain

exceptions as specified therein.

Failure to comply with these covenants would constitute an event of default under the Credit Agreement, notwithstanding the ability of BioReference to meet its debt service obligations.

The Credit Agreement also includes various customary remedies for the lenders following an event of default, including the acceleration of repayment of outstanding amounts under the Credit Agreement and execution upon the collateral securing obligations under the Credit Agreement.

Substantially all the assets of BioReference and its subsidiaries are restricted from sale, transfer, lease, disposal or distributions to the Company, subject to certain exceptions.

As of December 31, 2022, BioReference and its subsidiaries had net assets of approximately $ 608.6 million, which included goodwill of $ 283.0 million and intangible assets of $ 187.9 million.

On April 29, 2022, the Credit Agreement was amended to, among other things, (i) waive specified defaults under the Credit Agreement resulting from certain internal reorganization transactions that resulted in both BioReference and GeneDx changing their respective forms of organization from New Jersey corporations to Delaware limited liability companies, (ii) provide for the disposition of GeneDx pursuant to the transactions contemplated by the GeneDx Merger Agreement, (iii) amend certain reporting requirements under the Credit Agreement and (iv) provide that the borrowers under the Credit Agreement may effect certain restricted payments to the extent necessary for their parent entities to pay income tax in respect of income earned by the borrowers.

Note 3 Commitments and Contingencies

1 unchanged sentence

Note 4 Dividends

We received $45 million dividend payments from our consolidated subsidiaries for the year ended December 31, 2021.

We received a $12 million dividend payment from BioReference during the year ended December 31, 2020.

We received $ 33 million and $ 45 million dividend payments from our consolidated subsidiaries for the years ended December 31, 2022 and 2021, respectively.

Note 5 Income Taxes

2 unchanged sentences

Note 6 Subsequent Events

We have reviewed all subsequent events and transactions that occurred after the date of our December 31, 2021 Consolidated Balance Sheet date, through the time of filing this Annual Report on Form 10-K.

On January 2023, in conjunction with a underwritten public offering, we invested $ 5.0 million for 14,285,714 shares of GeneDx Holdings Class A common stock at a public offering price of $ 0.35 per share.

On or about February 10, 2023, the Company amended the 2023 Convertible Notes to extend the maturity to January 31, 2025, and to reset the conversion price to the 10 day volume weighted average price immediately preceding the date of the amended note, plus a 25 % conversion premium, or $ 1.66 .

In addition, under the terms of the 2023 Convertible Note, interest will accrue from the most recent date to which interest has been paid or, if no interest has been paid, from the date of issuance, until the principal and accrued and unpaid interest, are paid in full.

The remaining provisions of the original note are unchanged.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

March 1, 2022 OPKO HEALTH, INC.

February 27, 2023 OPKO HEALTH, INC.

/s/ Phillip Frost, M.D.

5 unchanged sentences

/s/ Phillip Frost, M.D.

Chairman of the Board and Chief Executive March 1, 2022

Chairman of the Board and Chief Executive February 27, 2023

Phillip Frost, M.D.

(Principal Executive Officer)

Hsiao, Ph.D., MBA Vice Chairman and Chief Technical Officer March 1, 2022

Hsiao, Ph.D., MBA Vice Chairman and Chief Technical Officer February 27, 2023

Hsiao, Ph.D., MBA

Zerhouni, M.D.

Vice Chairman and President February 27, 2023

Zerhouni, M.D.

/s/ Steven D.

Rubin Director and Executive Vice President – March 1, 2022

Rubin Director and Executive Vice President – February 27, 2023

Rubin Administration

/s/ Adam Logal Senior Vice President, Chief Financial Officer, March 1, 2022

/s/ Adam Logal Senior Vice President, Chief Financial Officer, February 27, 2023

Adam Logal Chief Accounting Officer and Treasurer

(Principal Financial Officer)

Cohen Director and Senior Vice President March 1, 2022

Nabel, M.D., Ph.D.

Director, Chief Innovation Officer February 27, 2023

Nabel, M.D., Ph.D.

/s/ Alexis Borisy Director February 27, 2023

Alexis Borisy

/s/ Richard Krasno, Ph.D.

Director March 1, 2022

Director February 27, 2023

Richard Krasno, Ph.D.

Director March 1, 2022

Paganelli Director March 1, 2022

Lachman, M.D.

Director February 27, 2023

Paganelli Director February 27, 2023

/s/ Richard C.

Pfenniger, Jr.

Director March 1, 2022

Director February 27, 2023

Pfenniger, Jr.

/s/ Alice Lin-Tsing Yu, M.D., Ph.D.

Director March 1, 2022

Director February 27, 2023

Alice Lin-Tsing Yu, M.D., Ph.D.

Exhibit Number Description

Form of Amended 5% Convertible Promissory Note dated February 10, 2023.

Subsidiaries of the Company.

13 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures