OPKO Health Inc.

Regulatory Filings • Jan 16, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 15, 2025

OPKO Health, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-33528			75-2402409
(State or Other Jurisdiction		(Commission			(IRS Employer
of Incorporation)		File Number)			Identification No.)
	4400 Biscayne Blvd.	Miami,	Florida	33137
	(Address of Principal Executive Offices)			(Zip Code)

Registrant's telephone number, including area code: (305) 575-4100

Not Applicable

Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value \$0.01 per share	OPK	NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

ITEM 7.01. Regulation FD Disclosure.

On January 15, 2025, members of management for OPKO Health, Inc. (the "Company") attended and will participate in meetings with investors at the 43rd Annual J.P. Morgan Healthcare Conference. A copy of the Company's presentation materials is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The presentation materials are also available on the Company's website at www.opko.com under Investor Relations. The information contained on the Company's website shall not be deemed part of this report.

The information contained in Item 7.01 to this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 as amended ("Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933 as amended ("Securities Act") or the Exchange Act, except as expressly set forth by specific reference in such a filing.

ITEM 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	OPKO Health, Inc. Presentation Materials
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

OPKO Health, Inc.

By: /s/ Steven D. Rubin

Date: January 15, 2025 Name: Steven D. Rubin Title: Executive Vice President - Administration

Forward-Looking Statements

This presentation contains "toward-looking statem is defined under the Private Securites Litigation Reform Act of 1995 (PS), which statements may be identified by words, "plans," projects," "will," "may," "anticipates," "shudd," "intends," "skinds," "and other words of similar meaning, including statements research and anticipated financed performance, and expectations regarding the market for and sales of our products, whether our product development of the expected benefits of our products will be realized, including whener the data for products in the will be positive and when a daily and dusting of dustlession of the suscessfully progress the development of oxyntomodulin in both subculanes whether we will contrue to repurchases shares under a buybock program and whether we will continue to purchase convertible notes, whether NGENLA profis will be sufficient to provide after satisting our obligations under the note purchase agreement, whether the with our commercial and strategic partners will be successful, our ability to market and sell any of our products in development, whill continue to successfuly advance products in our pipeline and whether they can be commercisized, whether BioReference will be able to streamlines and better posion the clicision for sustained growth and politability, whether BioReference's attumpts at returning is one believely will be successful, whicher on stategic efforts to gow the Company will utimatir be successful and create shareholder value as other non-historial statements about our expectations, beliefs or intentions regarding our business, technologies and products, francial condition, strospects. Narry factors could activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors in our Annual Reports on Form 10-K fled and to be filed with the Securities and Exchange Commission and under the hades" in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relations with our commercial partners in funding, developing and othering regulations organisms approvals of new, commercially-violent and treatments. In addition, forward-looking statements may also be ashersely affected by general market factors, competitive product availability, federal and state regulations and legistation, the regulatory process ind indications, manufacturing issues that may arse, paller factors. The foward-tooling statements contained in this pess release speak only as of the date the statements were made, and we do not undertake any obligation statements. We intend bat all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

2024 In Review: A Transformative Year

OPKO is well-positioned for growth and value across its businesses

ModeX Proprietary Technologies

Since OPKO's acquisition in May 2022, ModeX has further validated its core technologies and advanced 3 pipeline assets to clinical stages

ModeX Development Pipeline

ModeX has promising portfolio assets with 3 in clinical stage and 2 pre-IND assets to enter clinic in 2025

ModeX Partnerships and Business Development

OPKO has formed productive partnerships to share development costs and leverage commercial capabilities

Advancement in Long-Acting Biologics

OPKO Biologics has developed a robust technology and portfolio of long-acting therapeutic proteins and peptide drug candidates which have the potential to address large, high-need markets

Created NGENLA™ (somatrogon), once-weekly injectable hGH molecule now marketed by Pfizer in over 40 countries

V Utilize novel technologies to develop next-generation, bio-better, long-acting biologics

In-house expertise and state-of-the-art facilities in Israel support mission of developing new and better drugs

In Development: Oxyntomodulin Analog
Oral	Injectable
Collaborating on development of oral GLP2 and dual-agonist GLP-1/GCGR	Targeting treatment of diabetes, obesity and MASH
EnteraBio

Growth of Pharmaceutical Product Sales

Business lines across the globe generate durable, growing revenues

For Proches ended ORIORA (Jock Currenty groven compared to the same period in 2023
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Clinical Diagnostics Reset: A Streamlined BioReference

A re-calibration of the organization and improved cost structure position BioReference for profitability in 2025

Realignment of Capital Structure in 2024

A series of transactions in 2024 to recapitalize the balance sheet provide flexibility to execute long-term plans

		\$300M convertible note conversion from 2025 to 2029 maturity
Balance Sheet	\$250M	NGENLA royalty monetization with retention of upside and milestone rights of \$100M
Reset	\$238M	sale of clinical diagnostics and women's health assets outside NY & NJ to Labcorp		Strongly Positioned for 2025+ Enhanced Financial Position
	\$189M	proceeds from selling partial stake in GeneDx (NASDAQ:WGS)1	ક
				R&D Investment
Shareholder	\$90M	to repurchase and retire 81M shares (avg. of \$1.11 per share)2		Return Capital to Shareholders
Value		\$30M to repurchase convertible notes3

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3)

2025 Priorities to Generate Long-Term Value

Focused on execution of strategic priorities to produce clinical and financial success

Modex Pipeline Progression	Produce safety and early efficacy data for Ph1 assets Prepare 2 additional assets to enter clinical development Extend growth in non-dillutive partnerships
Biologics Development	Advance 2 molecules to IND stages Explore potential partnerships
Global Pharmaceutical Business	Maintain and accelerate revenue growth Improve profitability
BioReference	Continued strategic restructuring Grow share in NY & NJ market Achieve profitability
Enhanced Financial Strength	Recapitalized financials achieved in 2024 ensures sustained funding for R&D and commercial operations