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OPKO HEALTH (OPK)

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Earnings summaries and quarterly performance for OPKO HEALTH.

Recent press releases and 8-K filings for OPK.

OPKO Health Reports Q4 2025 Results, Highlights Regeneron Collaboration, and Issues 2026 Guidance
OPK
Earnings
Guidance Update
New Projects/Investments
  • OPKO Health reported Q4 2025 total revenues of $148.5 million and a net loss of $31.3 million, or $0.04 per share, ending the quarter with $369 million in cash and cash equivalents. The company provided FY 2026 total revenue guidance of $530 million to $560 million.
  • The company repurchased 9.8 million shares in Q4 2025 and 34.6 million shares for approximately $47 million in FY 2025, with $113 million remaining under its buyback authorization.
  • OPKO Health announced a new collaboration with Regeneron in Q4 2025, with potential milestones exceeding $1 billion. The company also received its first royalty payment of $4.3 million from Eli Lilly for mazdutide sales in China and saw a 30% increase in Pfizer's gross profit share for NGENLA to $12.5 million in Q4 2025.
  • Following the sale of oncology assets to Labcorp in mid-September 2025, BioReference's remaining operations generated approximately $300 million in revenue in 2025 and are expected to deliver positive operating income and cash flow in 2026. The 4Kscore test volume grew over 6% year-over-year in Q4 2025.
6 days ago
OPKO Health Reports Q4 2025 Financial Results and Provides 2026 Outlook
OPK
Earnings
Share Buyback
Guidance Update
  • OPKO Health reported Q4 2025 total revenues of $148.5 million and a net loss of $31.3 million, or $0.04 per share, compared to net income in the prior year period. The company ended the quarter with $369 million in cash and cash equivalents and restricted cash.
  • The diagnostics business underwent a significant transformation with the sale of its oncology division in September 2025, allowing BioReference to focus on its core clinical laboratory business and the 4Kscore test nationally.
  • The company advanced its therapeutic pipeline, including an EBV vaccine partnered with Merck and a collaboration with Regeneron that has potential milestones exceeding $1 billion. R&D expenses for Q4 2025 increased to $32.4 million.
  • OPKO returned capital to shareholders, repurchasing 9.8 million shares during Q4 2025 and a total of 34.6 million shares for approximately $47 million in 2025, with $113 million remaining under its buyback authorization.
  • For Q1 2026, total revenue is projected to be between $125 million and $140 million, and for full year 2026, total revenue is expected to be $530 million to $560 million.
6 days ago
OPKO Health Reports Q4 2025 Results, Highlights Diagnostics Transformation and Pipeline Progress
OPK
Earnings
Guidance Update
Share Buyback
  • OPKO Health reported Q4 2025 total revenues of $148.5 million and a net loss of $31.3 million, or $0.04 per share.
  • The diagnostics business, BioReference, completed the sale of its oncology division in September 2025, streamlining operations and positioning it for sustained profitable growth in 2026.
  • The company ended Q4 2025 with a strong cash position of $369 million and repurchased 34.6 million shares for approximately $47 million in 2025, with $113 million remaining under its buyback authorization.
  • OPKO's ModeX pipeline advanced with multiple clinical-stage programs and established a collaboration with Regeneron, which has a potential value exceeding $1 billion in milestones.
  • For full year 2026, the company expects total revenue between $530 million and $560 million.
6 days ago
OPKO Health Reports Q4 2025 Results and Provides 2026 Guidance
OPK
Earnings
Guidance Update
New Projects/Investments
  • OPKO Health reported consolidated total revenues of $148.5 million for the fourth quarter of 2025, a decrease from $183.6 million in the prior-year period, primarily due to the sale of certain BioReference assets. The company recorded a net loss of $31.3 million, or $0.04 per share, for Q4 2025.
  • The company provided financial guidance, projecting total revenues between $125 million and $140 million for Q1 2026 and between $530 million and $560 million for the full year 2026.
  • OPKO Health entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies, with potential milestone payments exceeding $1 billion if multiple products from the collaboration are successful.
  • As of December 31, 2025, cash, cash equivalents, and restricted cash totaled $369.1 million. The company repurchased $13.5 million of common stock in Q4 2025, contributing to a total of $87.3 million repurchased under the program since July 2024, with $112.7 million remaining authorized.
6 days ago
OPKO Health Reports Q4 2025 Results and Provides 2026 Guidance
OPK
Earnings
Guidance Update
New Projects/Investments
  • OPKO Health reported consolidated total revenues of $148.5 million for the fourth quarter of 2025, a decrease from $183.6 million in the prior-year period, primarily due to the sale of certain BioReference assets. The company recorded a net loss of $31.3 million, or $0.04 per share, in Q4 2025, contrasting with a net income of $14.0 million in Q4 2024 which included significant one-time gains.
  • The company provided financial guidance, expecting total revenues for Q1 2026 to be between $125 million and $140 million, and for the full year 2026, total revenues are projected to be $530 million to $560 million.
  • OPKO's ModeX subsidiary entered a research collaboration with Regeneron Pharmaceuticals, which includes an upfront payment and potential milestone payments exceeding $200 million for each program, with the overall potential value of the collaboration exceeding $1 billion.
  • Key pipeline advancements include MDX2003 approved for Phase 1 studies in Australia (expected H1 2026), MDX2001 advancing in its Phase 1 clinical trial (Phase 1b studies expected H1 2026), and FDA permission granted for Phase 1 studies of MDX2301 for COVID-19 (scheduled to begin Q2 2026).
  • The company repurchased $13.5 million of its common stock in Q4 2025, contributing to a total of $87.3 million repurchased since July 2024, with $112.7 million remaining authorized under the program.
6 days ago
OPKO Health Details Strategic Rebalancing, Pipeline Progress, and Financial Outlook at J.P. Morgan Healthcare Conference
OPK
New Projects/Investments
Guidance Update
Share Buyback
  • OPKO Health is strategically rebalancing its portfolio, focusing on therapeutics and divesting from clinical diagnostics, with the remaining diagnostic business projected to achieve 3%-5% revenue growth in 2026 from a $300 million base in 2025, aiming for single-digit EBITDA and cash flow positive operations by the end of 2026.
  • The company has a licensing agreement with Merck for an EBV vaccine, which includes $50 million upfront and potential milestones of $870 million, with Phase 1 complete and a Phase 2 decision expected in Q1 2026.
  • A collaboration with Regeneron involves four programs with potential milestones of $1.2 billion, providing non-dilutive financing for OPKO's multi-specific platform.
  • OPKO is advancing its clinical pipeline, including MDX-2001 (solid tumor, nearing end of Phase 1A) and MDX-2004 (immune system rejuvenation, in clinic), with plans to move MDX-2001 to Phase 1B this year. The company also has approximately $140 million remaining on its stock repurchase program.
Jan 14, 2026, 9:30 PM
OPKO Health Outlines Strategic Rebalancing and Pipeline Progress
OPK
New Projects/Investments
Share Buyback
Guidance Update
  • OPKO Health is rebalancing its business by divesting approximately 40% of its clinical diagnostic operations, with the remaining BioReference Health business projected to achieve break-even and profitability in 2026. The diagnostic segment is guided for 3%-5% revenue growth in 2026 from a $300 million base in 2025, targeting single-digit EBITDA and cash flow positive operations by year-end.
  • The company's biotech division, ModeX Therapeutics, has a significant partnership with Merck for an EBV vaccine, which has completed Phase 1 and is anticipated to enter Phase 2 in Q1 2026, with potential milestones up to $870 million.
  • ModeX also established a new collaboration with Regeneron covering four programs in obesity, cancer, and immunology, offering potential milestones of $1.2 billion.
  • OPKO's clinical pipeline includes MDX-2001 (solid tumor, nearing end of Phase 1A, moving to Phase 1B in 2026) and MDX-2004 (trispecific immune-rejuvenating antibody, in clinic).
  • The company has approximately $140 million remaining on its stock repurchase program, having returned over $100 million to shareholders in the past year.
Jan 14, 2026, 9:30 PM
OPKO Health Provides Strategic and Pipeline Update at J.P. Morgan Healthcare Conference
OPK
Guidance Update
New Projects/Investments
Share Buyback
  • OPKO Health is rebalancing its portfolio by focusing on therapeutics and divesting from clinical diagnostics, aiming for the remaining diagnostic business to reach break-even and profitability with projected 3%-5% revenue growth in 2026 off a $300 million base from 2025, and targeting single-digit EBITDA and cash flow positive operations by the end of 2026.
  • The Merck-partnered EBV vaccine has completed phase one, with a decision on phase two entry and an associated milestone payment expected in Q1 2026. The cancer solid tumor product MDX-2001 is nearing the end of phase 1A (23 patients treated) and will advance to phase 1B in 2026.
  • A Regeneron partnership for four programs provides non-dilutive financing with potential milestones of approximately $1.2 billion. Additionally, MDX-2004 (immune system rejuvenation) is in early clinical development, and the company plans to fully own its in vivo CAR T cell platform.
  • OPKO Health has approximately $140 million remaining in its stock repurchase program, having returned over $100 million to shareholders in the past year, with further guidance on capital allocation expected in February 2026.
Jan 14, 2026, 9:30 PM
Entera Bio Comments on FDA Qualification of Total Hip BMD as Regulatory Endpoint
OPK
New Projects/Investments
Guidance Update
  • Entera Bio announced the FDA's broad qualification of total hip bone mineral density (BMD) as a validated regulatory endpoint for novel osteoporosis drugs.
  • This qualification further bolsters Entera's July 2025 FDA alignment and regulatory strategy for EB613, which is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis.
  • In July 2025, Entera was the first company to receive FDA alignment that a single Phase 3 study with total hip BMD as primary endpoint would support an NDA for EB613.
Dec 23, 2025, 1:30 PM
OPKO Health Reports Q3 2025 Results, Completes Oncology Division Sale, and Announces Regeneron Collaboration
OPK
Earnings
M&A
Share Buyback
  • OPKO Health completed the sale of BioReference Health's oncology division, receiving $192.5 million at closing and an additional $32.5 million in a performance-based earnout, aiming to streamline its lab business.
  • The company reported a Q3 2025 consolidated operating income of $48.1 million and net income of $21.6 million, or $0.03 per basic and diluted share.
  • OPKO Health announced a research collaboration and license agreement with Regeneron, potentially yielding over $1 billion in milestone payments and tiered royalties for the development of multi-specific antibodies.
  • The company repurchased 11.1 million shares during Q3 2025, with $126 million remaining under its share repurchase program as of September 30.
  • For Q4 2025, OPKO Health expects total revenue between $135 million and $140 million and anticipates achieving break-even operating results.
Oct 29, 2025, 8:30 PM