OPKO Health — Third Quarter 2026 Earnings Summary

Financial Performance:

• Consolidated continuing operations revenue increased 16% year-over-year to $65.4 million from $56.4 million in the third quarter of 2025.
• Operating loss for continuing operations narrowed to $31.4 million from $33.6 million in the prior-year quarter.
• Net loss from continuing operations was $35.5 million ($0.05 per share), compared to $33.0 million ($0.04 per share) in the third quarter of 2025.
• Global Products segment revenue rose to $48.4 million from $39.4 million, driven by product sales of $41.8 million (up from $37.7 million).
• Rayaldee revenue increased to $8.6 million from $7.5 million, attributed to favorable gross-to-net adjustments from Medicare coverage changes.
• International operations revenue increased approximately $3.0 million, including a $0.7 million favorable foreign currency impact.
• Licensing, collaboration, and other revenue in Global Products grew to $6.6 million from $1.8 million, primarily due to $5.8 million in royalty revenue from Eli Lilly.
• Global Products segment operating income turned positive at $6.0 million, compared to an operating loss of $1.2 million in the prior-year quarter.
• Innovative Biotech segment revenue remained flat at $17.0 million; BARDA revenue decreased to $7.5 million from $8.2 million, partially offset by $0.8 million in Regeneron collaboration revenue.
• Research and development expenses in Innovative Biotech increased to $30.4 million from $26.3 million, reflecting higher investment in ModeX programs.
• Innovative Biotech operating loss widened to $26.8 million from $22.5 million.
• Unallocated corporate operating loss increased to $10.6 million from $9.9 million.
• Discontinued operations (BioReference) generated $71.8 million in revenue compared to $95.2 million in the prior year; net loss from discontinued operations was $18.0 million versus a net income of $54.6 million in the prior year (which included a $101.6 million gain on asset sales).
• Cash, cash equivalents, and restricted cash totaled $403.2 million as of September 30, 2026.
• Senior secured royalty financing on the balance sheet increased to $370.2 million from $246.4 million at December 31, 2025.
• Long-term portion of convertible notes increased to $92.5 million from $85.0 million.

Guidance and Future Outlook:

• OPKO withdrew guidance for services revenue and total costs and expenses due to uncertainty regarding the timing and impact of the pending Labcorp transaction.
• OPKO will continue to provide guidance for continuing operations.
• Full-year 2026 product revenue guidance is $164.0 million to $169.0 million.
• Full-year 2026 IP and other revenue guidance is $105.0 million to $110.0 million.
• Full-year 2026 total revenue guidance is $268.0 million to $278.0 million.
• Full-year 2026 total costs and expenses guidance is $390.0 million to $395.0 million.
• Full-year 2026 R&D expenses included in costs and expenses are guided at $125.0 million to $130.0 million.
• Full-year 2026 income/loss from discontinued operations is guided at a loss of $60.0 million to $70.0 million.
• Q4 2026 product revenue guidance is $41.0 million to $46.0 million.
• Q4 2026 IP and other revenue guidance is $21.0 million to $27.0 million.
• Q4 2026 total revenue guidance is $62.0 million to $72.0 million.
• Q4 2026 total costs and expenses guidance is $100.0 million to $105.0 million.
• Q4 2026 R&D expenses included in costs and expenses are guided at $32.0 million to $35.0 million.
• Q4 2026 income/loss from discontinued operations is guided at a loss of $35.0 million to $45.0 million.

Business Segments and Product Lines:

• OPKO entered an agreement with Labcorp to sell substantially all remaining BioReference diagnostic operations, with $722 million in cash consideration at closing and up to $150 million in additional consideration over ten years based on 4Kscore® test sales.
• OPKO Biologics dosed the first participant in a Phase 1/2a trial for OPK-8801001, a long-acting human growth hormone receptor antagonist for acromegaly.
• ModeX completed enrollment in the MDX2301 Phase 1 clinical trial for a tetravalent bispecific antibody targeting SARS-CoV-2 variants; early data is expected in late 2026 or early 2027.
• ModeX continues enrollment in MDX2001 (Trop2/c-Met tetraspecific T cell engager) and MDX2004 (trispecific immune rejuvenator) Phase 1 trials, with initial data expected in the first half of 2027.
• ModeX continues enrolling patients in the MDX2003 Phase 1 trial for relapsed or refractory B-cell lymphoma.
• OPKO continues U.S. enrollment in the Phase 1/2a study of OPK-88006, a dual GLP-1/glucagon receptor agonist for metabolic dysfunction-associated steatohepatitis (MASH).
• Single ascending dosing for OPK-88006 showed favorable safety and tolerability across three dose levels in 24 participants.

Market and Competitive Landscape:

• B-cell lymphoma represents the most common lymphoma subtype, accounting for approximately 85% of cases.
• International operations performance included stronger results in animal health and higher EirGen revenue driven by sales volumes and product mix.
• Foreign currency impacts included appreciation of the Chilean and Mexican pesos against the U.S. dollar.

Risks and Challenges:

• The pending Labcorp transaction remains subject to regulatory approvals and customary closing conditions.
• Forward-looking statements are subject to risks including the timing of the Labcorp transaction, receipt of anticipated purchase price, and clinical trial results.
• Actual results may differ materially from forward-looking statements due to risks described in OPKO's Form 10-K and other SEC filings.

Management Commentary and Tone:

• The new financial presentation classifies BioReference as discontinued operations to provide a clearer view of the biopharmaceutical businesses remaining post-transaction.
• Management highlighted the strategic shift to eliminate substantially all remaining diagnostic operations.
• The tone indicates confidence in the biopharmaceutical portfolio while acknowledging the uncertainty of the diagnostic sale closing.

Other Key Points:

• OPKO issued an additional $125 million aggregate principal amount of senior secured royalty notes to HealthCare Royalty, with payments linked to mazdutide license revenue from Eli Lilly.
• During the quarter, OPKO received approximately $123.1 million in net proceeds from the 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 for approximately $10.6 million during the quarter.
• As of September 30, 2026, approximately $115.7 million had been deployed under the $200 million share repurchase authorization, leaving $84.3 million available.
• The 2025 third quarter discontinued operations income included a $101.6 million gain on the sale of BioReference's oncology diagnostics business and clinical testing services assets to Labcorp.