Opko Health, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 26 February 2026: press release. Guidance figures: 16 new. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue fell on BioReference sale: Fourth-quarter total revenues were $148.5 million, down from $183.6 million, mainly from the 2025 sale of certain BioReference assets. Source
• Quarter swung to net loss: Net loss was $31.3 million, or $0.04 per share, against net income of $14.0 million, or $0.01 per diluted share, a year earlier. The 2024 quarter included a $54.1 million GeneDx share sale gain. Source
• Product revenue rose on currency and volume: Pharmaceutical product revenue was $43.7 million, against $37.4 million. The company cited a $4.0 million favorable foreign exchange effect and higher international sales volumes. Source
• Services revenue fell on divestiture: Diagnostics services revenue was $71.1 million, down from $103.1 million, mainly from the BioReference asset sale and lower clinical test volume. Source
• Regeneron multispecific collaboration terms: ModeX received an upfront payment under the Regeneron research collaboration, with milestone payments above $200 million per program. Total potential value exceeds $1 billion. Source
• SG&A fell: Selling, general and administrative expense was $50.5 million, against $67.0 million. Full-year expense was $223.0 million, against $304.2 million. Source
• Cash position declined: Cash, cash equivalents and restricted cash were $369.1 million at December 31, 2025, against $428.9 million at September 30, 2025. Source

“Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development”

Opko Health, Inc., press release

Guidance

What changed from last quarter

• New guidance: First-quarter and full-year 2026 financial guidance was introduced in this release; the prior release gave none. Source
• New: FDA granted permission to proceed to Phase 1 for MDX2301, a COVID-19 antibody candidate, supported by BARDA funding. Source
• New: An expanded partnership with Entera Bio adds a third program, an oral long-acting PTH tablet for hypoparathyroidism. Source
• New: MDX2003 was approved for Phase 1 studies in Australia, a regulatory step not in the prior release. Source

Results and growth drivers

• Revenue fell on BioReference sale: Fourth-quarter total revenues were $148.5 million, down from $183.6 million, mainly from the 2025 sale of certain BioReference assets. Source
• Quarter swung to net loss: Net loss was $31.3 million, or $0.04 per share, against net income of $14.0 million, or $0.01 per diluted share, a year earlier. The 2024 quarter included a $54.1 million GeneDx share sale gain. Source
• Full-year net loss widened: Full-year 2025 net loss was $225.7 million, or $0.30 per share, against $53.2 million, or $0.08 per share, in 2024. Source
• Operating loss widened: Fourth-quarter operating loss was $38.3 million, against $33.1 million a year earlier. Full-year operating loss narrowed to $117.4 million from $152.1 million. Source

Pharmaceuticals revenue mix

• Product revenue rose on currency and volume: Pharmaceutical product revenue was $43.7 million, against $37.4 million. The company cited a $4.0 million favorable foreign exchange effect and higher international sales volumes. Source
• Rayaldee sales dipped slightly: Rayaldee revenue was $8.8 million in the quarter, compared with $9.1 million a year earlier. Source
• IP and royalty revenue declined: Revenue from transfer of intellectual property and other was $33.7 million, against $43.1 million. The 2024 quarter included a $12.5 million Merck milestone; this quarter included a $7.0 million Regeneron upfront payment. Source
• Lilly royalty from China launch: Royalty revenue from Eli Lilly was $4.3 million, following the commercial launch of mazdutide in China by partner Innovent Biologics. Source
• NGENLA profit share payments rose: Gross profit share payments for NGENLA were $12.5 million, up from $9.6 million, which the company linked to Pfizer's global commercial progress. Source

“This new partnership leverages ModeX’s MSTAR technology platform with Regeneron’s proprietary binders”

Opko Health, Inc., press release

Diagnostics services decline

• Services revenue fell on divestiture: Diagnostics services revenue was $71.1 million, down from $103.1 million, mainly from the BioReference asset sale and lower clinical test volume. Source
• 4Kscore revenue grew 16%: 4Kscore revenue rose 16% to $7.0 million, on increased demand and higher average reimbursement. Full-year 4Kscore revenue was $27.1 million, up from $23.9 million. Source
• Transition charges hit diagnostics: Non-recurring transition-related adjustments of $5.8 million in the quarter came from severance, asset write-offs, third-party revenue adjustments and capital tax expense. Source
• Diagnostics costs and loss narrowed: Diagnostics costs and expenses were $89.4 million, against $124.8 million, and the operating loss was $18.3 million, against $21.7 million. Source

Pipeline programs and milestones

• MDX2001 reached fifth dose level: The MDX2001 tetraspecific antibody advanced to the fifth dose level in its Phase 1 trial. Source
• MDX2003 approved for Australian Phase 1: MDX2003, a trispecific T-cell engager-expander for leukemia and lymphoma, received approval for Phase 1 studies in Australia. Source
• Preclinical abstracts at ASH and SITC: Preclinical abstracts were presented for MDX2003 at ASH and MDX2004 at SITC 2025. MDX2003 prevented further tumor growth at low doses in an animal model. Source
• MDX2004 Phase 1/2a study ongoing: The MDX2004 Phase 1/2a study in advanced cancers is ongoing, designed to assess safety, tolerability and biologic activity. Source
• EBV vaccine Phase 1 completed: The Merck-partnered Epstein-Barr virus vaccine Phase 1 trial, in healthy adults, was completed in the fourth quarter of 2025. Source
• MDX2301 FDA permission to proceed: FDA granted permission to proceed to Phase 1 for MDX2301, a tetravalent bispecific antibody that neutralizes all known SARS-CoV2 strains. Source

“Additional studies are in progress to inform dose and adjuvant selection for potential Phase 2 studies.”

Opko Health, Inc., press release

Partnerships and collaboration terms

• Regeneron multispecific collaboration terms: ModeX received an upfront payment under the Regeneron research collaboration, with milestone payments above $200 million per program. Total potential value exceeds $1 billion. Source
• Regeneron funds development; ModeX gets royalties: Regeneron funds all preclinical and clinical development and commercialization. ModeX is eligible for tiered royalties on global net sales, reaching low double digits at the highest tier. Source
• Entera adds third PTH program: The Entera collaboration adds a long-acting PTH tablet program for hypoparathyroidism. OPKO and Entera each hold 50% and fund half of development costs. Source

Costs, margins and other income

• Total costs fell with divestiture: Quarterly total costs and expenses were $186.8 million, against $216.7 million. Full-year costs were $724.3 million, against $865.2 million, which included a $101.6 million gain on asset sales. Source
• R&D rose on early-stage programs: Research and development was $32.8 million, against $30.4 million, with full-year spending of $124.0 million against $105.2 million. Source
• SG&A fell: Selling, general and administrative expense was $50.5 million, against $67.0 million. Full-year expense was $223.0 million, against $304.2 million. Source
• Cost of service revenues declined: Cost of service revenues was $60.0 million, against $76.3 million, with full-year cost of $307.4 million against $402.1 million. Source
• Other expense replaced other income: Other expense, net was $8.6 million in the quarter, against other income of $68.0 million a year earlier. Full-year other expense was $124.0 million. Source
• Income tax swung to benefit: The quarter recorded an income tax benefit of $15.7 million, against a $20.9 million provision a year earlier. Source

Cash, debt and balance sheet

• Cash position declined: Cash, cash equivalents and restricted cash were $369.1 million at December 31, 2025, against $428.9 million at September 30, 2025. Source
• Convertible notes reduced: Long-term convertible notes were $85.0 million, down from $173.6 million a year earlier, while senior secured notes were $246.4 million. Source
• Total assets and equity: At year-end, total assets were $1,931.9 million and equity was $1,268.0 million. Source
• Receivables fell, inventory rose: Accounts receivable, net, fell to $90.3 million from $118.0 million, while inventory rose to $65.8 million from $56.8 million. Source

Share repurchase program

• Buybacks continued in Q4: About $87.3 million of stock had been repurchased under the program since July 2024, including $13.5 million in the fourth quarter. Source
• Remaining repurchase authorization: About $112.7 million remained authorized for future repurchases at year-end. Source
• Basic share count rose: Weighted average basic shares were 765,519,363 for the quarter, against 676,788,895 in the 2024 quarter. Source

Coming up, as management said on 26 February 2026

• MDX2001 Phase 1b start: Phase 1b studies in select solid tumors are expected to begin in the first half of 2026. Source
• MDX2003 Australian Phase 1 start: Phase 1 studies in Australia for MDX2003 are expected to start in the first half of 2026. Source
• MDX2301 healthy-volunteer trial: The healthy-volunteer trial is scheduled to begin in Q2 2026, with pharmacokinetic and immunogenicity data expected later in 2026. Source
• Entera PTH IND filing: The companies expect to file an IND application for the long-acting PTH tablet in late 2026. Source

Figures management reported

Risks management discussed

• Demand: Clinical test volume declined after the BioReference asset sale, as management described it. Source
• External: Lower clinical test reimbursement rates weighed on diagnostics revenue, partly offset by 4Kscore demand. Source

Earlier plans management reported on

• Not stated: The prior release said the trial was progressing well; this release reports the Phase 1 trial completed in Q4 2025. Source
• Not stated: The prior release gave an early-2026 expectation for Phase 1b; this release moved the window to the first half of 2026.
• Not stated: The prior release said part of the Labcorp sale proceeds would fund repurchases; this release reports the program continuing.

Other quarters

• Q3 FY2026 earnings call
• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.