OPKO Health Inc.

Regulatory Filings • Oct 26, 2023

OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023

MIAMI (October 25, 2023) – OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023. These data will be presented in a poster, "Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression" (#TH-PO1152) at 10:00 a.m. Eastern Yme in Exhibit Halls B-D by authors Charles W. Bishop Ph.D., Stephen A. Strugnell Ph.D. and Akhtar Ashfaq, M.D., FACP, FASN.

OPKO Health will present two other posters at ASN Kidney Week summarizing addiYonal new clinical data on RAYALDEE. One poster, "Extended-release Calcifediol Overcomes Impact of Low eGFR on Vitamin D Metabolism" (#FR-PO319), will be presented in the "Bone and Mineral Metabolism: Basic" session at 10:00 a.m. Eastern Yme on Friday, November 3, 2023, in Exhibit Halls B-D. The data demonstrate that RAYALDEE effecYvely and reliably raises serum levels of 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D in non-dialysis paYents with secondary hyperparathyroidism (SHPT), making it an acracYve alternaYve to vitamin D hormone therapies (i.e., calcitriol, paricalcitol and doxercalciferol).

The other poster, "Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism" (#FR-PO972), will be presented in the "CKD IntervenYons: Trials and Quality Improvement" session at 10:00 a.m. Eastern Yme on Friday, November 3, 2023 in Exhibit Halls B-D. The data demonstrate that effecYve control of SHPT has been achieved with RAYALDEE treatment in both randomized clinical trials and in a real-world clinical experience trial. Data from these trials support early iniYaYon of SHPT treatment with RAYALDEE in order to delay disease progression.

About RAYALDEE®

RAYALDEE is an extended-release (ER) oral formulaYon of calcifediol, a prohormone of calcitriol, the acYve form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug AdministraYon for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries. Slowing CKD progression with RAYALDEE treatment is not currently an approved indicaYon.

About OPKO Health, Inc.

OPKO is a mulYnaYonal biopharmaceuYcal and diagnosYcs company that seeks to establish industryleading posiYons in large, rapidly growing markets by leveraging its discovery, development, and commercializaYon experYse and novel and proprietary technologies. For more informaYon, visit www.opko.com.

CauDonary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined under the Private SecuriYes LiYgaYon Reform Act of 1995 (PSLRA), which statements may be idenYfied by words such as "expects," "plans," "projects," "will," "could," "may," "anYcipates," "believes," "should," "intends," "esYmates," and other words of similar meaning, including statements regarding the market for RAYALDEE, and our strategies or prospects and expectaYons about RAYALDEE, the therapeuYc benefits, safety profile or effecYveness of RAYALDEE or whether early iniYaYon of SHPT treatment with RAYALDEE would delay disease progression. Many factors could cause our actual acYviYes or results to differ materially from the acYviYes and results anYcipated in forward- looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the SecuriYes and Exchange Commission and in our other filings with the SecuriYes and Exchange Commission, as well as the risksthat the accuracy and effecYveness of the data may not be reproducible or indicaYve of future results and that currently available over-the-counter and prescripYon products, as well as products under development by others, may prove to be as or more effecYve than our products for the indicaYons being studied. In addiYon, forward-looking statements may also be adversely affected by general market factors, compeYYve product development, product availability, federal and state regulaYons and legislaYon, the regulatory process for new products and indicaYons, manufacturing issues that may arise, patent posiYons and liYgaYon, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligaYon to update forward- looking statements. We intend that all forward-looking statements be subject to the safe- harbor provisions of the PSLRA.

Contacts:

LHA Investor RelaYons Yvonne Briggs, 310-691-7100 ybriggs@lhai.com

or

Bruce Voss, 310-691-7100 bvoss@lhai.com

#