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Get filing alertsOPKO Health reports Q1 revenue decline to $124.2M, narrows loss, initiates two Phase 1 trials
Filed April 28, 2026 · Period ending April 28, 2026 · ~1 min read
Key Changes
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Q1 2026 revenue fell 17% YoY to $124.2M (from $149.9M) due to 2025 BioReference asset sale; operating loss improved 24% to $51.0M from $67.2M, net loss per share narrowed to $0.07 from $0.10
Exhibit 99.1 view on EDGAR → -
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Reaffirmed FY 2026 revenue guidance of $530-560M and provided Q2 guidance of $127-132M, implying sequential growth and acceleration through year-end
Exhibit 99.1 view on EDGAR → -
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Initiated Phase 1 trial for MDX2301, a BARDA-funded tetravalent COVID-19 antibody targeting all known SARS-CoV-2 variants; completed first dose cohort in healthy and high-risk immune-impaired adults
Exhibit 99.1 view on EDGAR → -
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Launched Phase 1 trial for MDX2003, a first-in-class tetraspecific T-cell engager for relapsed/refractory B-cell lymphoma (85% of non-Hodgkin lymphoma cases)
Exhibit 99.1 view on EDGAR → -
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Exhibit 99.1 view on EDGAR →
Summary
The company reaffirmed full-year revenue guidance of $530-560 million, with Q2 guidance of $127-132 million suggesting sequential improvement and acceleration through the remainder of the year. On the pipeline front, OPKO initiated two Phase 1 trials during the quarter. MDX2301, a BARDA-funded tetravalent antibody for COVID-19 prevention, completed its first dose cohort and targets all known SARS-CoV-2 variants.
MDX2003, a first-in-class tetraspecific T-cell engager, entered Phase 1 for relapsed/refractory B-cell lymphoma, addressing a large market (85% of non-Hodgkin lymphoma). For retail holders, the narrowing losses and pipeline progress are constructive, though revenue growth remains dependent on pharmaceutical segment execution and the guidance trajectory through year-end.
Section-by-Section Diff
Event · Item 2.02 — Results of Operations and Financial Condition
OPKO Health disclosed Q1 2026 operating and financial results via press release and scheduled a conference call to discuss performance and guidance.
Added in current filing · verify on EDGAR →
On April 28, 2026, OPKO Health, Inc. (the “Company”) issued a press release announcing operating and financial highlights for the quarter ended March 31, 2026.
OPKO Health announced its first quarter 2026 operating and financial results through a press release. The 8-K does not include the actual financial figures or performance metrics, which are contained in the attached press release exhibit. The company is also hosting a conference call to provide a business update and discuss the quarterly results along with financial guidance.
Event · Exhibit 99.1
Added in current filing · view on EDGAR →
Initiated MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19xCD20xCD3xCD28) is a novel tetraspecific T-cell engager-expander designed to optimize sustained T-cell function and address the two most common and validated targets in lymphomas and leukemias. The MDX2003 Phase 1 study (NCT07249905) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MDX2003 in adults with various types of B-cell lymphoma.
OPKO initiated a Phase 1 trial for MDX2003, a first-in-class tetraspecific T-cell engager targeting relapsed/refractory B-cell lymphoma. The trial will evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. B-cell lymphoma represents approximately 85% of non-Hodgkin lymphoma cases, indicating a large addressable market if the therapy proves effective.
Added in current filing · view on EDGAR →
Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO's proprietary long-acting PTH variants with Entera's proprietary N-Tab® technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program's development costs.
OPKO expanded its partnership with Entera Bio to develop an oral long-acting PTH tablet for hypoparathyroidism, with an IND filing expected in late 2026. The companies share 50/50 ownership and development costs. Favorable pharmacodynamic and pharmacokinetic data from December 2025 prompted acceleration of the program, suggesting clinical promise for this first-in-class oral formulation.
Added in current filing · view on EDGAR →
For the three months ended June 30, 2026 | For the year ended December 31, 2026 | Low | High | Low | High | Revenue: | Services revenue | $ 72 | $ 76 | $ 300 | $ 312 | Product revenue | 38 | 42 | 160 | 170 | IP and other revenue | 15 | 19 | 70 | 80 | Total revenue | 127 | 132 | 530 | 560
OPKO provided Q2 2026 revenue guidance of $127-132 million and reiterated full-year 2026 guidance of $530-560 million. The Q2 midpoint of $129.5 million represents modest sequential growth from Q1's $124.2 million. Full-year guidance implies Q2-Q4 average quarterly revenue of approximately $135-145 million, suggesting expected acceleration through the year driven by pharmaceutical revenue growth and stable diagnostics performance.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 22, 2026 · How we verify