OPKO Health

What OPKO Health does

OPKO Health, Inc. (NASDAQ: OPK) is a diversified healthcare company founded in 1991 (as Cytoclonal Pharmaceutics, renamed OPKO in 2007) and headquartered in Miami, Florida, operating two reportable segments: pharmaceuticals and diagnostics. The pharmaceutical segment is anchored by two FDA-approved marketed products — NGENLA (somatrogon), a once-weekly human growth hormone therapy approved in over 50 markets globally and commercialized through an exclusive 2014 partnership with Pfizer that delivered $295 million upfront and tiered gross profit share payments, and Rayaldee (extended-release calcifediol), approved in the U.S. (2016) and 11 European countries for secondary hyperparathyroidism in adults with stage 3-4 chronic kidney disease. The diagnostics segment centers on BioReference Health, a clinical reference laboratory serving approximately 11 million patients annually in NY/NJ, and the proprietary 4Kscore prostate cancer biomarker test, which received a 2025 FDA label expansion enabling use without digital rectal examination.

The company's R&D engine is built on proprietary technology platforms: the CTP (Carboxyl Terminal Peptide) half-life extension technology underlying NGENLA, the MSTAR multispecific antibody platform acquired through the $300 million ModeX Therapeutics acquisition in May 2022, a ferritin-based nanoparticle vaccine platform, an in-vivo CAR-T (Ab-LNP) platform, and an oral peptide delivery technology developed in collaboration with Entera Bio. ModeX's pipeline has expanded to five clinical programs including MDX2001 (tetraspecific for solid tumors), MDX2003 (tetraspecific for B-cell lymphomas), MDX2004 (trispecific T-cell rejuvenator), MDX2301 (BARDA-funded COVID bispecific antibody), and an EBV nanoparticle vaccine partnered with Merck. EirGen Pharma, OPKO's Irish subsidiary, operates a high-containment manufacturing facility exporting high-potency oral solid dose pharmaceuticals to over 60 countries.

OPKO generates revenue through multiple streams: licensing royalties and gross profit share payments from Pfizer for NGENLA (recordings of $31.9 million year-to-date for 2025); product sales and royalties from Rayaldee across U.S. and partner territories; clinical laboratory testing services through BioReference; development and regulatory milestone payments from collaborations with Merck, Regeneron (potential exceeding $1 billion total), and BARDA; and royalty monetization through a $250 million note purchase agreement with HealthCare Royalty. Following the divestiture of BioReference's clinical, reproductive, women's health, and oncology assets to Labcorp in 2024-2025 for total consideration of up to $462.5 million, OPKO restructured to approximately 1,373 full-time employees as of December 31, 2025, refocusing on specialty pharmaceuticals and regional specialty diagnostics with $369 million in cash at Q1 2026 and 2026 revenue guidance of $530-560 million.

Name

OPKO Health

Legal name

OPKO Health, Inc.

Website

https://opko.com

Company type

Public

Founded year

1991

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

OPKO Health is a diversified healthcare company developing specialty pharmaceuticals (NGENLA via Pfizer, Rayaldee) and clinical diagnostics (BioReference Health, 4Kscore), with a multispecific antibody pipeline through ModeX Therapeutics and global manufacturing via EirGen Pharma.

Ownership category

akta.pro rank

Product category

Specialty Biopharmaceuticals and Diagnostics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151)

SIC

Pharmaceutical Preparations (2834), Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Nephrology & Urology Pharmaceuticals (HLAIAAAM)

akta.pro secondary industries

Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Specialty pharmaceuticals
• Clinical diagnostics services
• Multispecific antibodies
• Biopharmaceutical manufacturing
• Prostate cancer diagnostics

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Sales and Royalties: NGENLA generates tiered gross profit share payments from Pfizer covering both NGENLA and Genotropin in all global markets where Pfizer commercializes. Rayaldee generates product sales in US and royalty revenue from European (Vifor) and Asian (Nicoya, LeaderMed) partners.
2. Diagnostics Services: Clinical laboratory testing services including routine, esoteric, urology (4Kscore), women's health, and correctional healthcare through BioReference Health operating in NY/NJ markets.
3. Royalty Monetization: $250 million note purchase agreement with HealthCare Royalty secured by profit share payments from Pfizer related to NGENLA, providing non-dilutive capital while retaining upside from future payments.
4. Milestone Payments: Collaborations with Regeneron (potential >$1B in milestones and royalties), Merck (EBV vaccine), and BARDA generate development and regulatory milestone payments.

Go-to-market motion3 records

Distribution channels6 records

Marketing channels5 records

Core offering

OPKO Health is a diversified healthcare company that develops, manufactures, and commercializes specialty pharmaceuticals and clinical diagnostics. Its pharmaceutical offerings include two FDA-approved products—NGENLA, a once-weekly human growth hormone co-developed with Pfizer, and Rayaldee for secondary hyperparathyroidism in chronic kidney disease—alongside a pipeline of multispecific antibodies and vaccines through its ModeX Therapeutics subsidiary and oral peptide programs co-developed with Entera Bio. Its diagnostics segment operates BioReference Laboratories, one of the largest full-service U.S. clinical reference laboratories serving approximately 11 million patients annually, and the proprietary FDA-approved 4Kscore prostate cancer risk assessment test.

Product overview

OPKO Health is a diversified healthcare company operating two primary segments: pharmaceuticals and diagnostics. The pharmaceutical segment includes two FDA-approved marketed products (NGENLA human growth hormone therapy partnered with Pfizer, and Rayaldee for secondary hyperparathyroidism), a ModeX Therapeutics subsidiary developing multispecific antibodies for cancer and infectious diseases (MDX2001, MDX2003, MDX2004, MDX2301), peptide programs (OPK88006, OPK8801001), and collaboration programs with Entera Bio (EB612, EB618 oral peptides). The diagnostics segment features BioReference Laboratories (core clinical testing in NY/NJ), the proprietary 4Kscore prostate cancer test, and BioReference Direct consumer-initiated testing platform. Global commercial operations span Ireland (EirGen), Spain, Mexico, and Chile. The company leverages proprietary technology platforms including the CTP half-life extension technology, MSTAR multispecific antibody platform, and Nanoparticle Vaccine platform.

Differentiator

Problem solved

Functional benefit

Brands

• NGENLA: FDA-approved once-weekly human growth hormone therapy for pediatric growth hormone deficiency; partnered with Pfizer globally
• RAYALDEE
• 4Kscore Test
• MSTAR Platform
• EirGen Pharma
• ModeX Therapeutics

Products and services

• NGENLA (somatrogon) FDA-approved once-weekly human growth hormone therapy for pediatric patients with growth hormone deficiency, developed using proprietary CTP technology to extend circulating half-life; administered via disposable pen to reduce daily injection burden and improve adherence. Commercialized globally in over 50 markets through partnership with Pfizer.
• Rayaldee (extended-release calcifediol) FDA-approved extended-release oral calcifediol (25-hydroxyvitamin D3) for treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency where standard OTC vitamin D supplements are inadequate; commercialized in the United States and licensed to regional partners for Europe, China, and Asia.
• BioReference Health Clinical Laboratory Services Comprehensive clinical reference laboratory services including routine, esoteric, molecular diagnostics, anatomical pathology, genetics, women's health, and correctional healthcare testing delivered to physician offices, clinics, hospitals, employers, health plans, academic institutions, and governmental agencies; concentrated in New York/New Jersey.
• 4Kscore Test Proprietary laboratory-developed blood test measuring four prostate-derived kallikrein proteins (Total PSA, Free PSA, Intact PSA, hK2) combined with patient clinical data to calculate individualized probability of aggressive prostate cancer on biopsy; FDA-approved with 2025 label expansion enabling use without DRE information, with demonstrated ability to reduce unnecessary prostate biopsies by over 50%.
• BioReference Direct Consumer-Initiated Testing Consumer-initiated diagnostic testing platform providing fully integrated digital access to OPKO's BioReference laboratory testing services for individual consumers.
• EirGen Pharma High-Potency Oral Solid Dose Contract Manufacturing Specialized high-potency oral solid dose pharmaceutical development and commercial supply services from a 77,700-square-foot FDA-, EMA-, and PMDA-approved facility in Ireland, exporting to over 60 countries globally and estimated to double annual output capacity to approximately 1 billion units by 2027.

Quantifiable outcome

• NGENLA Phase 3 demonstrated non-inferiority to daily somatropin in annual height velocity
• +4 more outcomes

Named customers8 records

Segments6 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Ten partnerships are on record, tiered core, flagship and minor.

• Entera Bio Ltd.coreStrategic or Co-development Partner · 1 February 2026Expanded partnership to develop first oral long-acting PTH analog tablet for hypoparathyroidism. Both companies hold 50% ownership and share development costs equally. IND filing expected late 2026. Includes oral OXM (60/40 OPKO ownership) and oral GLP-2 programs.
• Regeneron PharmaceuticalsflagshipStrategic or Co-development Partner · 28 October 2025Strategic license and collaboration to discover and develop multispecific antibodies using ModeX's MSTAR platform combined with Regeneron's proprietary binders. OPKO/ModeX receives $7M upfront with potential milestone payments exceeding $200M per selected molecule and overall collaboration value exceeding $1B.
• LabcorpcoreOthers · 1 September 2025Two separate divestiture transactions: September 2024 sale of clinical diagnostics, reproductive health, and women's health businesses (excluding NY/NJ) for $237.5M cash; September 2025 sale of oncology diagnostics business for up to $225M including $32.5M potential earnout. Total consideration up to $462.5M.
• BARDA (Biomedical Advanced Research and Development Authority)coreStrategic or Co-development Partner · 28 September 2023Federal contract awarded to ModeX for development of multispecific antibody platform and product candidates addressing public health threats including MDX2301 COVID bispecific antibody and influenza antibody candidate. Funded by U.S. Department of Health and Human Services.
• Merck Sharp & Dohme LLCcoreStrategic or Co-development Partner · 1 March 2023ModeX granted exclusive sublicensable royalty-bearing license to Merck for preclinical EBV nanoparticle vaccine candidate. Merck completed Phase 1 enrollment (>200 subjects) with subgroup analyses underway. Data expected to inform Phase II design by year-end.
• LeaderMed Health Group LimitedminorChannel Partner/ Reseller/ Distributor · 14 September 2021Joint venture for OPK88006 (oxyntomodulin) and Factor VIIa-CTP in Greater China and 8 Asian countries. OPKO retains 47% ownership; LeaderMed and partners invested $11M for 53% stake and fund operations. OPKO retains rights in all other geographies.
• Nicoya TherapeuticscoreChannel Partner/ Reseller/ Distributor · 18 June 2021Exclusive license for development and commercialization of Rayaldee in Greater China. OPKO received 15% equity stake (Series A-2 Preferred) in amended April 2026 agreement. Product launched in Macau November 2024; regulatory approvals in mainland China expected 2027. Up to $115M in milestones.
• Vifor Fresenius Medical Care Renal Pharma (VFMCRP)coreChannel Partner/ Reseller/ Distributor · 1 May 2016Development and license agreement for Rayaldee in Europe, Australia, and certain international markets. VFMCRP assumed prior partner rights; Rayaldee launched in Germany and Switzerland with authorizations in 11 European countries. Option to acquire U.S. dialysis rights.
• Pfizer Inc.flagshipStrategic or Co-development Partner · 1 December 2014Exclusive worldwide agreement for development and commercialization of Somatrogon (hGH-CTP). OPKO received $295M upfront and $175M in regulatory milestones; eligible for additional $50M upon SGA approval. Pfizer handles global commercialization with OPKO entitled to tiered gross profit share covering both NGENLA and Genotropin.
• Eli Lilly and CompanyminorStrategic or Co-development Partner · 25 February 2010License agreement for OPK88003 (oxyntomodulin) and OPK88004 (SARM) compounds. OPKO receives royalty payments for certain licensed intellectual property. Patents covering compounds licensed from Eli Lilly.

Scale indicators15 records

Recent moves9 records

Expansion highlights5 records

Broad incumbents

• Amgen: Amgen markets cinacalcet (Sensipar) and etelcalcetide (Parsabiv) for secondary hyperparathyroidism in CKD patients, making it the established competitor to Rayaldee in the same indication; both companies compete for the same nephrology endocrinology patient population across dialytic and pre-dialytic CKD.
• Quest Diagnostics: Quest is one of the two largest U.S. clinical reference laboratory networks and a direct competitor to BioReference in the regional and specialty clinical testing market; OPKO's NY/NJ-focused laboratory business competes head-to-head with Quest's broader national footprint.
• Novo Nordisk: Novo Nordisk markets Norditropin, the leading daily human growth hormone therapy that competes with OPKO/Pfizer's once-weekly NGENLA; despite operating from a vastly larger resource base, Novo's hGH franchise is the most direct therapeutic comparator driving Pfizer's commercial urgency.
• Labcorp: Labcorp acquired BioReference's clinical diagnostics and oncology businesses from OPKO in two transactions totaling up to $462.5M in 2024-2025, making it both a strategic counterparty and the closest incumbent reference laboratory competitor to OPKO's remaining BioReference Health franchise in NY/NJ.

Emerging players

• MDxHealth: MDxHealth commercializes SelectMDx and other urological/prostate cancer diagnostic tests that compete with OPKO's 4Kscore test franchise in the prostate cancer risk assessment specialty testing market.
• MacroGenics: MacroGenics is a clinical-stage biopharma developing multi-specific DART and TRIDENT antibody therapeutics for oncology, directly competing in the same multispecific antibody oncology space as ModeX's MDX2001, MDX2003 and MDX2004 programs.
• Genmab: Genmab is a leading biotechnology company developing proprietary antibody therapeutics platforms including bispecifics (DuoBody), structurally analogous to ModeX's MSTAR multispecific platform; both compete in the multispecific antibody space with IP-driven platforms generating royalty/milestone revenue from major pharma partners.

Direct peers

• Supernus Pharmaceuticals: Supernus is a specialty branded CNS pharma company focused on differentiated products in neurology, similar to OPKO's specialty pharmaceutical positioning across endocrinology and nephrology; both rely heavily on proprietary formulation/technology advantages and partner-driven commercialization strategies.
• Ironwood Pharmaceuticals: Ironwood is a specialty GI pharma company with both a partnered asset (Linzeess) generating royalties and an internal pipeline, structurally analogous to OPKO's combination of Pfizer-partnered NGENLA royalties plus the ModeX pipeline of multispecific antibody candidates; both have partnered assets providing cash and early-stage wholly-owned pipeline bets.
• Jazz Pharmaceuticals: Jazz Pharmaceuticals is a specialty branded pharma company with a diversified portfolio of marketed neurology, oncology, and rare disease products, comparable to OPKO's specialty pharma franchise spanning endocrinology (NGENLA), nephrology (Rayaldee) and specialty diagnostics (4Kscore). Both companies monetize niche, differentiated branded therapies via partner-led commercialization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/search
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• LinkedInlinkedin.com/company/opko-health-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries8 records

Funding overview

Funding rounds5 records

Investors1 record

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M&A11 records

Investments14 records

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Frequently asked questions about OPKO Health