Annual Report • Mar 22, 2025
Annual Report
Open in ViewerOpens in native device viewer
WASHINGTON, DC 20549
Amendment No. 1
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024.
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
(Exact Name of Registrant as Specified in Its Charter)
Delaware 75-2402409 (State or Other Jurisdiction of Incorporation or Organization)
(I.R.S. Employer Identification No.)
4400 Biscayne Blvd. Miami, FL 33137 (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:
Common Stock, \$.01 par value per share OPK NASDAQ Global Select Market
Title of Each Class Trading Symbol Name of Each Exchange on Which Registered
Securities registered pursuant to section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
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. 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 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). 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.
| Large accelerated filer | ☒ | Accelerated 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 has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentivebased compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, as of the last business day of the registrant's most recently completed second fiscal quarter was: \$414,913,527.
As of January 31, 2025, the registrant had 671,550,270 shares of its common stock, par value \$0.01 per share ("Common Stock") outstanding.
Portions of the registrant's definitive proxy statement for its 2025 Annual Meeting of Stockholders are incorporated by reference in Items 10, 11, 12, 13, and 14 of Part III of this Annual Report on Form 10-K.
OPKO Health, Inc., a Delaware corporation (the "Company"), is filing this Amendment No. 1 on Form 10-K/A (the "Amendment" or "Form 10-K/A") to amend and restate Part III, Item 10. Directors, Executive Officers and Corporate Governance to include XBRL tagging and to amend and restate Part IV, Item 15, Exhibits and Financial Statement Schedules of its Annual Report on Form 10-K for the year ended December 31, 2024 originally filed with the U.S. Securities and Exchange Commission (the "SEC") on March 3, 2025 (the "Original 10-K"), which inadvertently included the OPKO Health, Inc. Related Party Transaction Policy as Exhibit 19.1 instead of the Company's Insider Trading Policy. Accordingly, Part IV, Item 15, Exhibits and Financial Statement Schedules has been amended and restated in its entirety to include the Company's Insider Trading Policy as Exhibit 19.1.
In accordance with Rules 12b-15 and 13a-14 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), we have also amended Part IV, Item 15, Exhibits and Financial Statement Schedules to include currently dated certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from our principal executive officer and principal financial officer. Because no financial statements have been included in this Amendment and this Amendment does not contain or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4 and 5 of the certifications have been omitted. Similarly, because no financial statements have been included in this Amendment, certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 have been omitted.
Except as described above, this Amendment does not amend, update or change any other disclosures in the Original 10-K. In addition, the information contained in this Amendment does not reflect events occurring after the filing of the Original 10-K and does not modify or update the disclosures therein, except as specifically identified above.
Ernst & Young LLP PCAOB ID No. 42 Miami, Florida
| Part III. | 4 | |
|---|---|---|
| Item 10. | Directors, Executive Officers and Corporate Governance | 4 |
| Part IV. | 5 | |
| Item 15. | Exhibits, Financial Statement Schedules | 5 |
| Signatures | 10 | |
| Certifications | 11 | |
| EX-31.1 | ||
| EX-31.2 | ||
| EX-101. INS XBRL Instance Document | ||
| EX-101.SCH XBRL Taxonomy Extension Schema Document | ||
| EX-101.CAL XBRL Taxonomy Extension Calculation Linkbase Document | ||
| EX-101.DEF XBRL Taxonomy Extension Definition Linkbase Document | ||
| EX-101.LAB XBRL Taxonomy Extension Label Linkbase Document | ||
| EX-101.PRE XBRL Taxonomy Extension Presentation Linkbase Document | ||
3
Page
Except to the extent included below, the information required in Items 10 (Directors, Executive Officers and Corporate Governance), Item 11 (Executive Compensation), Item 12 (Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters), Item 13 (Certain Relationships and Related Transactions, and Director Independence), and Item 14 (Principal Accounting Fees and Services) is incorporated by reference to the Company's definitive proxy statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of December 31, 2024.
We have adopted a Code of Business Conduct and Ethics. We require all employees, including our principal executive officer, principal financial officer, principal accounting officer and other senior officers and our employee directors, to read and to adhere to the Code of Business Conduct and Ethics in discharging their work-related responsibilities. Employees are required to report any conduct that they believe in good faith to be an actual or apparent violation of the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at http://www.OPKO.com. Any amendment to, or waivers of, the Code of Business Conduct and Ethics will be disclosed on our website promptly following the date of such amendment or waiver.
We have adopted an Insider Trading Policy which governs the purchase, sale and/or any other dispositions of our securities by the Company and its directors, officers and employees and is reasonably designed to promote compliance with insider trading laws, rules and regulations and applicable exchange listing standards. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
(1) Exhibits: See Index to Exhibits below.
| Exhibit Number |
Description |
|---|---|
| 2.1+ | 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 the Securities and Exchange Commission on July 25, 2011, and incorporated herein by reference. |
| 2.2 | 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., 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. |
| 2.3 | Agreement and Plan of Merger, dated as of May 9, 2022, by and among the Company, ModeX Therapeutics, Inc., Orca Acquisition Sub, Inc. and Gary J. 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. |
| 2.4++ | Asset Purchase Agreement, dated as of March 27, 2024 by and among BioReference Health, LLC, OPKO Health, Inc. and Laboratory Corporation of America Holdings, filed with the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2024, and incorporated herein by reference. |
| 3.1 | 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, 2013 for the Company's three-month period ended September 30, 2013, and incorporated herein by reference. |
| 3.2 | Amended and Restated Bylaws, 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. |
| 3.3 | 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, 2009, and incorporated herein by reference. |
| 3.4 | 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 21, 2019, and incorporated herein by reference. |
| 3.5 | Composite Amended and Restated Certificate of Incorporation of OPKO Health, Inc., filed with the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024, and incorporated herein by reference. |
10.7 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, 2018, and incorporated herein by reference.
10.8 Share Lending Agreement, dated February 4, 2019, by and between the OPKO Health, Inc. 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.
Report on Form 8⁃K filed with the Securities and Exchange Commission on May 4, 2022, and incorporated herein by reference.
23.1 Consent of Ernst & Young LLP., filed with the Company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on March 3, 2025, and incorporated herein by reference.
31.1** Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
** Filed herewith.
+ Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
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.
By: /s/ Adam Logal
Adam Logal Senior Vice President, Chief Financial Officer, Chief Accounting Officer
| Exhibit Number | Description |
|---|---|
| 19.1 | OPKO Health, Inc. Insider Trading Policy. |
| 31.1 | Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024. |
| 31.2 | Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024. |
| Exhibit 101.INS | Inline XBRL Instance Document |
| Exhibit 101.SCH | Inline XBRL Taxonomy Extension Schema Document |
| Exhibit 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| Exhibit 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| Exhibit 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document |
| Exhibit 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| Exhibit 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
This Insider Trading Policy provides guidelines to all personnel ("Restricted Persons"), including employees (both domestic and international), directors and officers, of OPKO Health, Inc. and its subsidiaries (the "Company"), with respect to transactions in the Company's securities and the handling of material non-public information about the Company and the companies with which it does business. In the discretion of the Company's Compliance Officer, this Insider Trading Policy may also apply to consultants to and contractors of the Company and its subsidiaries who may come into possession of such material non-public information as a result of their work for or on behalf of the Company.
For purposes of this Insider Trading Policy, the Company's securities include common stock, options to purchase common stock and any other securities the Company may issue from time to time, such as preferred stock, warrants, convertible debentures and debt securities. The Company's securities also include derivative securities relating to the Company's securities, even if not issued by the Company, such as exchange-traded options.
The Company's directors, officers and certain designated employees are subject to additional limitations, including preclearance and blackout restrictions, described separately in the Company's Pre-clearance and Blackout Policy.
It is the policy of the Company to comply with all insider trading laws and regulations.
Restricted Persons may create, use or have access to material information about the Company that is not generally available to the investing public (such information is referred to in this Insider Trading Policy as "material non-public information," as explained in more detail below). Each Restricted Person has an important ethical and legal obligation to maintain the confidentiality of such information and not to engage in any transactions in the Company's securities while in possession of material non-public information of the Company. Each Restricted Person and the Company may be subject to severe civil and criminal penalties as a result of unauthorized disclosure of material nonpublic information of the Company or trading in the Company's securities while in possession of material non-public information of the Company.
The Compliance Officer or, in the Compliance Officer's absence, the Chief Accounting Officer, is responsible for the administration of this Insider Trading Policy. For purpose of this Insider Trading Policy, the Company's Deputy General Counsel shall be the Compliance Officer.
This prohibition also applies to information about, and to the trading of securities of, other companies (e.g., customers or suppliers) with which the Company has a relationship until such information becomes public or is no longer material.
This Insider Trading Policy does not apply to the exercise of employee stock options. However, this Insider Trading Policy does apply to the sale of securities of the Company as part of a broker-assisted cashless exercise of an option, or any other market sale for the purpose of generating the cash needed to pay the exercise price of an option.
There are no exceptions to this Insider Trading Policy. Engaging in transactions in the Company's securities that are otherwise necessary for personal reasons, such as personal financial commitments, are still prohibited if you possess material non-public information of the Company.
Transactions by Family Members; Entities Controlled by You. The prohibitions outlined in this Insider Trading Policy also apply to any "family members," who reside with you, anyone else who lives in your household and any other family member whose transactions in the Company's securities are directed by you or subject to your influence or control and any entities under your control. "Family Members" includes your spouse, any child, stepchild, grandchild, parent, stepparent, grandparent, sibling, mother or father-in-law, son or daughter-in-law, or brother or sister-in-law (as well as other adoptive relationships) with whom you share a household. The Company will hold you responsible for the conduct of your family members, anyone who lives in your household and any entities under your control.
Tipping Information to Others. You may not disclose any material non-public information to others, including your family members, friends or social acquaintances. This prohibition applies whether or not you receive any benefit from the other person's use of that information. The Securities and Exchange Commission (the "SEC") has imposed large civil and criminal penalties on the person providing the tip, the individual receiving the tip (the "tippee") and all those to whom the tippee, in turn, gives the information, even when the disclosing person did not profit from the trading.
Material Information. Information is considered "material" if a reasonable investor would likely consider it important in making a decision to purchase, hold or sell the Company's securities (e.g., information regarding a possible merger or acquisition involving the Company, the introduction of important products or major marketing changes). In addition, any information that could affect the market for the Company's securities is material. It is important to keep in mind that material information need not be certain or definitive information. Even information concerning events, actions, results, etc. that may happen can be considered material under certain circumstances.
Non-public Information. Non-public information is any information that has not been disclosed generally to the investing public. Disclosure by press release or in the Company's periodic reports filed with the SEC is necessary to make the information public. However, even after the Company has released information to the public, you should generally allow at least two (2) full trading days (that is, days on which the American Stock Exchange, the other national stock exchanges and Nasdaq are open for trading) for the investing public to absorb and evaluate the information before you trade in the Company's securities.
Although it is not possible to list all types of material information, the following are a few examples of information that is particularly sensitive and should be treated as material:
If you have any question as to whether particular information is material or non-public, you should not trade or communicate the information to anyone without prior approval by the Compliance Officer.
Inadvertent Disclosure. If material non-public information is inadvertently disclosed by any Restricted Person to a person outside the Company who is not obligated to keep the information confidential, you should immediately report all the facts to the Compliance Officer, or such other individual designated by the Company so that the Company may take appropriate remedial action. Under the SEC's rules, the Company generally has only 24 hours after learning of an inadvertent disclosure of material nonpublic information to publicly disclose such information, if necessary.
Short-term, Speculative Transactions. The Company has determined that there is a substantial likelihood for the appearance of improper conduct by Restricted Persons when they engage in short-term or speculative securities transactions. Therefore, Restricted Persons are prohibited from engaging in any of the following activities involving the Company's securities, except with the prior written consent of the Compliance Officer:
(a) purchasing the Company's securities on margin;
(e) engaging in derivative transactions relating to the Company's securities (e.g., exchange traded options, etc.)/
Further Prohibition. From time to time, effective immediately upon notice or as otherwise provided by the Company, the Company may determine that other types of transactions, or all transactions, by Company personnel in the Company's securities shall be prohibited or shall be permitted only with the prior written consent of the Compliance Officer.
Confidentiality Guidelines. To provide more effective protection against the inadvertent disclosure of material nonpublic information about the Company or the companies with which it does business, the Company has adopted the following guidelines in addition to the prohibition in paragraph 3 above. These guidelines are not intended to be exhaustive. Additional measures to secure the confidentiality of information should be undertaken as deemed necessary under the circumstances. If you have any doubt as to your responsibilities with respect to confidential information, please seek clarification and guidance from the Compliance Officer before you act. Do not try to resolve any uncertainties on your own.
The following guidelines establish procedures with which every Restricted Person must comply in order to maximize the security of confidential information:
(d) Maintain records in accordance with the Company's document retention policies in effect from time to time.
Authorized Disclosure of Material Non-Public Information. Under certain circumstances, the Compliance Officer may authorize the immediate release of material non- public information. If disclosure is authorized, the form and content of all public disclosures shall be approved by the Compliance Officer pursuant to the terms of the Company's applicable policies and procedures. In the case of material non-public information that is not disclosed, such information is not to be disclosed or discussed except on a strict "need-to-know" basis. All requests for information, comments, or interviews (other than routine product inquiries) made to any Restricted Person of the Company should be directed immediately to the Compliance Officer, who will clear all proposed responses in accordance with applicable law and the Company's policies and procedures. It is anticipated that most questions raised can be answered by the Compliance Officer or another company representative to whom the Compliance Officer refers the request. Restricted Persons should not respond to such requests directly, unless expressly instructed otherwise by the Compliance Officer. In particular, great care should be taken not to comment on the Company's expected future financial results without the express instruction by the Compliance Officer. If the Company wishes to give some direction to investors or securities professionals, it must do so only in compliance with the Company's policies and applicable law. All communications with representatives of the media and securities analysts shall be directed to the Compliance Officer.
Company Assistance. If you have any questions about specific information or proposed transactions, or as to the applicability or interpretation of this Insider Trading Policy or the propriety of any desired action, you are encouraged to contact the Compliance Officer.
Post-Termination Transactions. The restrictions set forth in this Insider
Trading Policy continue to apply to your transactions in the Company's securities even after the termination of your employment or term in office, as applicable, for such period as the Compliance Officer shall determine you are likely to be in possession of material non-public information about the Company. If you are in possession of material non-public information when your employment terminates, you may not trade in the Company's securities until that information has become public or is no longer material.
Date: March 21, 2025 /s/Phillip Frost, M.D.
Phillip Frost, M.D. Chief Executive Officer
Date: March 21, 2025 /s/ Adam Logal
Adam Logal Senior Vice President, Chief Financial Officer, Chief Accounting Officer and Treasurer
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.