OPKO Health Reports Third Quarter 2026 Business Highlights and Financial Results

(NASDAQ:OPK) OPKO Health, Inc. reported business highlights and financial results for the third quarter ended September 30, 2026. OPKO entered into an agreement with Labcorp for the sale of substantially all remaining BioReference diagnostic operations, with $722 million in cash consideration at closing, subject to adjustments, and up to $150 million in additional cash consideration over up to ten years based on Labcorp sales of the 4Kscore® test. The transaction is subject to regulatory approvals and customary closing conditions. OPKO expanded its strategic relationship with HealthCare Royalty through a $125 million financing, issuing an additional $125 million aggregate principal amount of senior secured royalty notes, with the amended framework including specified royalty payments receivable under OPKO’s license agreement with Eli Lilly and Company related to mazdutide. OPKO Biologics dosed the first participant in a Phase 1/2a trial of OPK-8801001 for acromegaly, designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamic activity. ModeX completed enrollment in the MDX2301 Phase 1 clinical trial, funded by BARDA, and continues enrollment in MDX2001 and MDX2004 Phase 1 trials at sites in Australia and Israel, with initial data expected in the first half of 2027. ModeX is also enrolling patients in the MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. OPKO continues U.S. enrollment in the Phase 1/2a study of OPK-88006, with favorable safety and tolerability observed in 3 dose levels in 24 participants. Following the Board’s September 30, 2026 approval of the BioReference sale plan, BioReference’s historical results are presented as discontinued operations. Consolidated continuing operations revenue in Q3 2026 increased 16% to $65.4 million from $56.4 million in Q3 2025, mainly due to higher royalty revenue from Lilly, increased Rayaldee sales, and growth in international operations. Operating loss in Q3 2026 decreased to $31.4 million from $33.6 million in Q3 2025. Non-cash depreciation, amortization, and equity-based compensation expense included in operating income (loss) was $20.7 million in Q3 2026 versus $20.5 million in Q3 2025. Net loss from continuing operations in Q3 2026 was $35.5 million, or $0.05 per share, compared to $33.0 million, or $0.04 per share, in Q3 2025. Global Products segment revenue for Q3 2026 increased to $48.4 million from $39.4 million in Q3 2025, with Rayaldee revenue rising to $8.6 million from $7.5 million. Revenue from international operations increased by approximately $3.0 million, including a $0.7 million favorable foreign currency impact. Licensing, collaboration, and other revenue for Q3 2026 increased to $6.6 million from $1.8 million, primarily driven by $5.8 million of royalty revenue from Lilly. Global Products segment operating income for Q3 2026 was $6.0 million compared to an operating loss of $1.2 million in Q3 2025. Innovative Biotech licensing, collaboration, and other revenue was $17.0 million in both Q3 2026 and Q3 2025. BARDA revenue in Q3 2026 was $7.5 million compared to $8.2 million in Q3 2025. Research and development expense for Q3 2026 increased to $30.4 million from $26.3 million in Q3 2025. Innovative Biotech segment operating loss in Q3 2026 was $26.8 million compared to $22.5 million in Q3 2025. Unallocated corporate operating loss in Q3 2026 was $10.6 million compared to $9.9 million in Q3 2025. BioReference generated revenue of $71.8 million in Q3 2026 compared to $95.2 million in Q3 2025, with a loss from discontinued operations, net of tax, of $18.0 million in Q3 2026 versus income of $54.6 million in Q3 2025. Cash, cash equivalents, and restricted cash were $403.2 million as of September 30, 2026. OPKO received approximately $123.1 million of net proceeds from the additional royalty financing and $19.8 million from the release of escrow funds related to the September 2025 oncology transaction. OPKO repurchased 7,050,000 shares during the quarter for approximately $10.6 million, with $115.7 million deployed under the $200 million share repurchase authorization, leaving $84.3 million available. OPKO has withdrawn previously issued guidance for services revenue and total costs and expenses due to uncertainty regarding the timing of the Labcorp transaction closing.

Preclinical Data for OPKO Biologics' OPK8801001 in Acromegaly Presented at ENDO 2026

(NASDAQ:OPK) OPKO Health, Inc. announced that OPKO Biologics, an OPKO Health company, presented preclinical data for OPK8801001 at ENDO 2026, the Endocrine Society’s annual meeting. The poster, “Production and Characterization of OPK8801001, a Novel Long-Acting hGH Receptor Antagonist for the Treatment of Acromegaly,” was presented by Moran Golan, Ph.D., Director of Preclinical & Clinical Pharmacology at OPKO Biologics. In vivo data showed that OPK8801001 produced robust, dose-dependent, sustained suppression of insulin-like growth factor-1 (IGF-1), a marker of disease activity in acromegaly. In vitro data demonstrated that OPK8801001’s potent growth hormone receptor antagonism is approximately 20-fold greater than Pegvisomant, a current therapy for acromegaly. The findings suggest the potential for a weekly alternative to currently available daily treatments. OPKO Biologics' pipeline includes first in class candidates for endocrinology indications such as hypoparathyroidism (HPT) and Short Bowel Disease (SBS). The company projects that OPK8801001 could reduce the burden of daily therapy for patients.