Earnings summaries and quarterly performance for OPKO HEALTH.
Executive leadership at OPKO HEALTH.
Board of directors at OPKO HEALTH.
Research analysts who have asked questions during OPKO HEALTH earnings calls.
ET
Edward Tenthoff
Piper Sandler Companies
4 questions for OPK
Also covers: ARVN, ARWR, CAPR +14 more
YC
Yi Chen
H.C. Wainwright & Co.
4 questions for OPK
Also covers: ANGO, APDN, BLFS +22 more
MP
Michael Petusky
Barrington Research
3 questions for OPK
Also covers: ANIK, HAE, HSIC +8 more
YJ
Yale Jen
Laidlaw & Company (UK) Ltd.
3 questions for OPK
Also covers: AFMD, ALDX, ARCT +13 more
JS
James Stamos
Jefferies Financial Group Inc.
2 questions for OPK
MR
Maurice Raycroft
Jefferies Financial Group
2 questions for OPK
Also covers: ABEO, AFMD, ALNY +14 more
DB
Destiny Buch
Ladenburg Thalmann & Co. Inc.
1 question for OPK
Also covers: BNGO, CCLD, NBY +1 more
Recent press releases and 8-K filings for OPK.
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
OPKO Health Reports Q3 2025 Financial Results and Strategic Business Highlights
OPK
Earnings
M&A
Share Buyback
- OPKO Health, Inc. reported Q3 2025 consolidated total revenues of $151.7 million and net income of $21.6 million, or $0.03 per diluted share, which included a $101.6 million gain from the sale of BioReference oncology assets.
- The company entered a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies, with potential milestone payments exceeding $200 million for each program and an overall collaboration value potentially exceeding $1 billion.
- OPKO completed the sale of BioReference Health's oncology and related clinical assets to Labcorp for $225 million, with $192.5 million paid at closing, and has repurchased approximately $73.8 million of common stock under its program, with $126.2 million remaining authorized.
- The FDA approved a supplemental application for the 4Kscore® Test in July 2025, enabling its performance without digital rectal examination information.
Oct 29, 2025, 8:11 PM
OPKO Health Reports Q3 2025 Financial Results, Announces Regeneron Collaboration and Asset Sale
OPK
Earnings
M&A
New Projects/Investments
- OPKO Health reported total revenues of $151.7 million for the third quarter of 2025, compared to $173.6 million for the same period in 2024, with net income of $21.6 million or $0.03 per diluted share.
- The company completed the sale of BioReference Health's oncology and related clinical assets to Labcorp for $225 million, receiving $192.5 million at closing, and intends to utilize a portion of the proceeds for its share repurchase program.
- OPKO entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies, with potential milestone payments that could exceed $1 billion if multiple products are successful.
- The FDA approved a supplemental application for the 4Kscore® Test, allowing its performance without digital rectal examination information.
Oct 29, 2025, 8:05 PM
OPKO Health's ModeX Therapeutics Announces Collaboration with Regeneron
OPK
New Projects/Investments
- ModeX Therapeutics, an OPKO Health company, has entered a license and collaboration agreement with Regeneron Pharmaceuticals Inc. to discover and develop multispecific antibodies for several therapeutic indications.
- Under the terms of the agreement, ModeX will receive an upfront payment of $7 million.
- The collaboration has a potential total value exceeding $1 billion if multiple products are successful, with potential future payments exceeding $200 million per selected molecule and tiered global net sales royalties up to low double digits.
- Regeneron will fund and lead all preclinical, clinical development, and commercialization activities for any products it elects to advance.
Oct 29, 2025, 12:00 PM
OPKO Health Completes Sale of BioReference Health's Oncology and Clinical Testing Businesses to Labcorp
OPK
M&A
Share Buyback
- On September 15, 2025, OPKO Health, Inc. completed the sale of select oncology and oncology-related clinical testing services businesses of its subsidiary, BioReference Health, to Labcorp.
- The total purchase price for the transaction is up to $225 million, including $192.5 million paid at closing and up to $32.5 million in a contingent earnout based on performance.
- BioReference Health will retain its core clinical testing operations in the New York and New Jersey region and its 4Kscore® Test franchise, which generated approximately $300 million in revenue for 2024.
- OPKO intends to utilize a portion of the proceeds from the sale to fund its recently expanded share repurchase authorization.
Sep 15, 2025, 8:02 PM
Entera Bio and OPKO Health Report Positive Preclinical Data for Oral GLP-2 Tablet
OPK
Product Launch
New Projects/Investments
- Entera Bio, in collaboration with OPKO Health, presented positive preclinical pharmacokinetic data for their oral GLP-2 analog, OPK-8801003, for Short Bowel Syndrome (SBS) at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress on September 15, 2025.
- The OPK-8801003 GLP-2 tablet demonstrated an extended half-life of approximately 15 hours in minipigs, an 18-fold improvement over teduglutide, and robust oral bioavailability with peak plasma concentrations reaching ~200 ng/ml (Cmax).
- This oral tablet candidate aims to provide a less-invasive administration for the approximately 30,000 SBS patients who currently rely on daily injections of Gattex®, which generates approximately $800 million in annual sales.
Sep 15, 2025, 1:00 PM
Quarterly earnings call transcripts for OPKO HEALTH.
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