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Opko Health, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 1 raised, 3 narrowed, 9 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose 16 percent: Continuing-operations revenue rose to $65.4 million from $56.4 million, mainly on higher Lilly royalty revenue, higher Rayaldee sales and growth in international operations. Source
  • Global Products moved to operating income: Global Products revenue rose to $48.4 million from $39.4 million; segment operating income was $6.0 million against an operating loss of $1.2 million. Source
  • BioReference loss against prior gain: Loss from discontinued operations was $18.0 million, against income of $54.6 million; the 2025 result included a $101.6 million gain on the sale of BioReference’s oncology diagnostics business. Source
  • Labcorp sale economics set out: The Labcorp agreement provides $722 million in cash at closing, adjusted for business revenues at closing, plus up to $150 million over up to ten years tied to Labcorp sales of the 4Kscore test. Source
  • Cash and restricted cash higher: Cash, cash equivalents and restricted cash were $403.2 million at September 30, 2026, against $314.4 million at June 30, 2026 on a measure that also included marketable securities. Source
  • First OPK-8801001 participant dosed: First participant dosed in a Phase 1/2a trial of OPK-8801001, a long-acting growth hormone receptor antagonist for acromegaly, with a goal of once-weekly administration. Source

“This presentation is intended to provide a clearer view of the biopharmaceutical businesses that will remain with OPKO following the planned transaction.”

Opko Health, Inc., press release

Guidance

AreaPeriodFigureAgainst last quarter
Product revenue Sourcethree months ended December 31, 2026$ 41.0 to $ 46.0New
Product revenue Sourceyear ended December 31, 2026$ 164.0 to $ 169.0Narrowed, top end cut from $ 164 to $ 174
IP and other revenue Sourcethree months ended December 31, 202621.0 to 27.0New
IP and other revenue Sourceyear ended December 31, 2026$ 105.0 to $ 110.0Raised from $ 100 to $ 105
Total revenue Sourcethree months ended December 31, 2026$ 62.0 to $ 72.0New
Total revenue Sourceyear ended December 31, 2026$ 268.0 to $ 278.0
Pfizer gross profit share Sourcethree months ended December 31, 2026$ 12.5 to $ 15.0New
Pfizer gross profit share Sourceyear ended December 31, 2026$ 34.0 to $ 37.0Kept
BARDA revenue Sourcethree months ended December 31, 20263.0 to 5.0New
BARDA revenue Sourceyear ended December 31, 202620.0 to 22.0Narrowed, low end up from 18 to 22
Total costs and expenses (continuing operations) Sourcethree months ended December 31, 2026100.0 to 105.0New
Total costs and expenses (continuing operations) Sourceyear ended December 31, 2026390.0 to 395.0
R&D included in costs and expenses Sourcethree months ended December 31, 202632.0 to 35.0New
R&D included in costs and expenses Sourceyear ended December 31, 2026125.0 to 130.0Narrowed, top end cut from 125 to 135
Income (loss) from discontinued operations Sourcethree months ended December 31, 2026(35.0) to (45.0)New
Income (loss) from discontinued operations Sourceyear ended December 31, 2026(60.0) to (70.0)New

What changed from last quarter

  • Guidance withdrawn: Full-year guidance for services revenue and total costs and expenses withdrawn, citing timing of the potential Labcorp closing. Source
  • New guidance: Guidance for the fourth quarter and full year 2026 issued on a continuing-operations basis. Source
  • Guidance raised: Full-year IP and other revenue range raised to $105 million to $110 million from $100 million to $105 million. Source
  • Guidance lowered: Full-year product revenue high end lowered to $169 million from $174 million. Source
  • Guidance lowered: Full-year R&D expense high end lowered to $130 million from $135 million. Source
  • New: Agreement to sell substantially all remaining BioReference diagnostic operations to Labcorp. Source
  • New: Additional $125 million of senior secured royalty notes issued under an expanded HealthCare Royalty financing. Source
  • New: Continuing operations now reported in two segments, Global Products and Innovative Biotech, with corporate costs shown separately. Source
  • New: BioReference results presented as discontinued operations for all periods, with prior periods recast, after the held-for-sale classification. Source

Results and growth drivers

  • Revenue rose 16 percent: Continuing-operations revenue rose to $65.4 million from $56.4 million, mainly on higher Lilly royalty revenue, higher Rayaldee sales and growth in international operations. Source
  • Operating loss narrowed; net loss widened: Net loss from continuing operations was $35.5 million, or $0.05 per share, against $33.0 million, or $0.04 per share, a year earlier. Source
  • Nine-month operating loss narrowed: For the nine months ended September 30, 2026, consolidated operating loss was $81.4 million against $118.9 million, and total revenues were $206.5 million against $159.2 million. Source
  • Net loss including discontinued operations: Net loss including discontinued operations was $53.5 million, or $0.07 per share, against net income of $21.6 million a year earlier. Source

Segments and regions

  • Global Products moved to operating income: Global Products revenue rose to $48.4 million from $39.4 million; segment operating income was $6.0 million against an operating loss of $1.2 million. Source
  • Innovative Biotech loss widened: Innovative Biotech segment operating loss was $26.8 million against $22.5 million a year earlier, as ModeX development programs took more spending. Source
  • Corporate costs edged up: Unallocated corporate operating loss was $10.6 million, reflecting employee-related and general administrative expenses not allocated to segments. Source

“Because the planned disposition represents a strategic shift that will eliminate substantially all remaining diagnostic operations”

Opko Health, Inc., press release

Products and licensing income

  • Rayaldee sales rose on gross-to-net adjustments: Rayaldee revenue increased, which the company attributed to favorable gross-to-net adjustments linked to changes in Medicare coverage. Source
  • International operations grew on animal health: International operations revenue rose about $3.0 million on animal health and higher EirGen volumes and mix; currency added about $0.7 million. Source
  • Licensing income rose on Lilly royalty: Licensing, collaboration and other revenue reached $6.6 million, mainly $5.8 million of Lilly royalty revenue, partly offset by lower EirGen milestone revenue. Source
  • BARDA revenue fell; Regeneron offset: BARDA revenue fell to $7.5 million from $8.2 million; $0.8 million of Regeneron collaboration revenue substantially offset the decline, and Pfizer royalty revenue was steady. Source

Costs and other items

  • Total costs rose modestly: Total costs and expenses for continuing operations were $96.8 million against $90.0 million; nine-month costs were $287.9 million against $278.1 million. Source
  • R&D spend rose: Research and development expense was $32.2 million against $29.8 million, and $94.3 million for the nine months against $90.3 million. Source
  • Non-cash charges held steady: Non-cash depreciation, amortization and equity-based compensation within operating loss was $20.7 million, against $20.5 million. Source
  • Other expense fell; investee loss added: Other expense, net was $6.4 million against $7.4 million; income tax benefit was $7.3 million against $8.0 million; loss from investments in investees was $5.0 million. Source
  • Intangible amortization unchanged year over year: Amortization of intangible assets was $16.5 million in both the third quarter of 2026 and the prior-year quarter. Source

“In preclinical studies, OPK-8801001 produced robust, dose dependent sustained suppression of insulin-like growth factor-1 (IGF-1), a key marker of disease activity in acromegaly.”

Opko Health, Inc., press release

BioReference discontinued operations

  • BioReference revenue fell: BioReference revenue was $71.8 million against $95.2 million in the prior-year quarter. Source
  • BioReference loss against prior gain: Loss from discontinued operations was $18.0 million, against income of $54.6 million; the 2025 result included a $101.6 million gain on the sale of BioReference’s oncology diagnostics business. Source
  • Diagnostics held for sale: Current assets held for sale were $248.1 million at September 30, 2026, up from $13.1 million at December 31, 2025; noncurrent held-for-sale assets fell from $244.5 million to nil. Source

Labcorp sale and royalty financing

  • Labcorp sale economics set out: The Labcorp agreement provides $722 million in cash at closing, adjusted for business revenues at closing, plus up to $150 million over up to ten years tied to Labcorp sales of the 4Kscore test. Source
  • Closing still needs approvals: Closing of the Labcorp sale is conditioned on regulatory approvals and customary closing conditions. Source
  • Royalty notes add $125 million: Additional $125 million of senior secured royalty notes issued; the framework includes specified royalty payments receivable under the Eli Lilly license for mazdutide. Source

Capital, cash and returns to shareholders

  • Cash and restricted cash higher: Cash, cash equivalents and restricted cash were $403.2 million at September 30, 2026, against $314.4 million at June 30, 2026 on a measure that also included marketable securities. Source
  • Royalty proceeds and escrow release: Net proceeds of about $123.1 million came from the additional royalty financing, and about $19.8 million from release of escrow tied to the September 2025 oncology transaction. Source
  • Share buybacks in the quarter: The company repurchased 7,050,000 shares for about $10.6 million; about $115.7 million of the $200 million authorization has been used, leaving about $84.3 million. Source
  • Royalty financing liability increased: Senior secured royalty financing rose to $370.2 million from $246.4 million at December 31, 2025. Source

Pipeline and clinical programs

  • First OPK-8801001 participant dosed: First participant dosed in a Phase 1/2a trial of OPK-8801001, a long-acting growth hormone receptor antagonist for acromegaly, with a goal of once-weekly administration. Source
  • MDX2301 enrollment completed: Enrollment completed in the MDX2301 Phase 1 trial of a bispecific antibody for COVID-19 prevention, funded by BARDA. Source
  • MDX2003 enrollment continues: Enrollment continues in the MDX2003 Phase 1 study, a tetraspecific T-cell engager-expander, in relapsed or refractory B-cell lymphoma. Source
  • MDX2001 and MDX2004 enrollment continues: MDX2001 (solid tumors) and MDX2004 (trispecific immune rejuvenator) Phase 1 enrollment continues as planned; MDX2004 sites are in Australia and Israel. Source
  • OPK-88006 safety reported in first part: The single ascending dose portion reported safety and tolerability across 3 dose levels in 24 participants; the multiple ascending dose portion is enrolling at 4 sites. Source

Coming up, as management said on 4 November 2026

  • MDX2301 early data timing: Early data from the MDX2301 Phase 1 trial is expected to be presented in late 2026 or early 2027. Source
  • MDX2001 and MDX2004 data in 2027: Initial safety, tolerability, pharmacokinetic and immune data for MDX2001 and MDX2004 are expected in the first half of 2027. Source
  • Continuing-operations guidance continues: The company will keep issuing guidance for its continuing operations. Source

Figures management reported

FigureReported
Rayaldee revenue (three months ended September 30, 2026) Source$8.6 million
Revenue from products (three months ended September 30, 2026) Source$41.8 million
Lilly royalty revenue (three months ended September 30, 2026) Source$5.8 million
Research and development expense, consolidated (three months ended September 30, 2026) Source$32.2 million
MDX2301 Phase 1 enrollment status SourceEnrollment completed
OPK-88006 single ascending dose participants Source24 participants at 3 dose levels

Risks management discussed

  • Financial: Services guidance was withdrawn because the timing of the potential Labcorp closing and its effect on financial results are uncertain. Source
  • Regulatory: The Labcorp sale still needs regulatory approvals and customary closing conditions before it can complete. Source
  • Financial: The cash at closing is subject to adjustment based on business revenues at closing, so the amount received may differ from the headline figure. Source

Earlier plans management reported on

  • Met: The prior release planned enrollment completion in the third quarter of 2026; this release reports enrollment completed. Source
  • Not stated: The prior release planned clinical trials for the end of 2026; this release reports the first participant dosed. Source
  • On track: Management states MDX2001 continues to enroll as planned. Source
  • On track: Management states MDX2004 continues Phase 1 enrollment as planned at sites in Australia and Israel. Source

Other quarters

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.