• Diagnostic Segment Revenue: $103.1 million for Q4 2024, compared to $124.2 million for Q4 2023.
• Pharmaceutical Segment Revenue: $80.5 million for Q4 2024, compared to $57.7 million for Q4 2023.
• Net Income: $14 million for Q4 2024, or $0.01 per diluted share, compared to a net loss of $66.5 million for Q4 2023.
• Operating Loss (Diagnostic Segment): $21.7 million for Q4 2024, compared to $42.3 million for Q4 2023.
• Operating Loss (Pharmaceutical Segment): $2.1 million for Q4 2024, compared to $16.1 million for Q4 2023.
• Cash and Cash Equivalents: Approximately $495 million at the end of 2024.
• R&D Expenses: $29.8 million for Q4 2024, compared to $18.7 million for Q4 2023.
• Revenue from RAYALDEE: $9.1 million for Q4 2024, similar to $9.3 million for Q4 2023.
• Revenue from Transfer of IP: $43.1 million for Q4 2024, compared to $14.7 million for Q4 2023.
• Gross Profit Share from Pfizer: $9.5 million for Q4 2024, compared to $12.2 million for Q4 2023.
• BARDA R&D Funding: $11 million for Q4 2024, compared to $1.2 million for Q4 2023.
• Depreciation and Amortization (Diagnostic Segment): $6 million for Q4 2024, compared to $8.1 million for Q4 2023.
• Depreciation and Amortization (Pharmaceutical Segment): $18.1 million for Q4 2024, compared to $17.9 million for Q4 2023.

• Warning! GuruFocus has detected 8 Warning Signs with OPK.

Release Date: February 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• OPKO Health Inc (NASDAQ:OPK) made significant progress with its ModeX pipeline, with two programs entering Phase 1 clinical trials.
• The company realigned its capital structure, resulting in a strong financial position to advance its pharmaceutical pipeline.
• OPKO Health Inc (NASDAQ:OPK) received a $50 million upfront payment from Merck for its Epstein-Barr virus vaccine collaboration, with potential for additional milestone payments.
• The company's BioReference Health segment showed improvement, with a reduction in operating losses and a clear path toward profitability.
• OPKO Health Inc (NASDAQ:OPK) reported a net income of $14 million for Q4 2024, a significant improvement from a net loss in the previous year.

Negative Points

• Revenue from the Diagnostic segment decreased to $103.1 million in Q4 2024, down from $124.2 million in the same period of 2023.
• The company incurred $4.5 million in non-recurring costs related to severance and facility closures during the fourth quarter.
• Operating loss for the Diagnostic segment was $21.7 million in Q4 2024, although improved from the previous year's loss.
• Research and development expenses increased significantly to $29.8 million, impacting overall profitability.
• The company anticipates utilizing up to $100 million of cash in operations, which could affect liquidity if not managed carefully.

Q & A Highlights

Q: Can you provide more details on when BioReference might reach profitability and how you plan to balance spending while expanding the oncology testing menu? A: Adam Logal, CFO, stated that they expect to achieve breakeven in the first quarter and profitability thereafter. The focus is on efficiency, and there is no significant investment being made into the test menu.

Q: What can you tell us about the $12.5 million milestone for Merck related to the EBV program, and what are the expectations for Phase 2? A: Phillip Frost, CEO, mentioned that the decision to move to Phase 2 could be made by the third quarter, which would trigger a significant milestone. However, specific milestone amounts cannot be disclosed until they are earned.

Q: Could you elaborate on the dual agonist with Entera Bio, specifically regarding the form and target patient population? A: Elias Zerhouni, President, explained that there are both injectable (weekly) and oral (daily) forms being pursued. The target populations include diabetics, obese patients, and those with fatty liver disease.

Q: What are the expectations for the RAYALDEE launch in China with Nicoya? A: Elias Zerhouni stated that the initial launch will be small, expanding after formal NDA approval. The transaction is milestone and royalty-driven, and updates will be provided in due course.

Q: Can you provide more details on the BARDA funding and its timeline? A: Adam Logal mentioned that they expect $40 million to $48 million in 2025. Elias Zerhouni added that the funding will support development through Phase 1 and potentially into Phase 2, with the total budgetary envelope being $205 million.

Q: What should we expect in terms of ModeX data for the cancer program this year? A: Phillip Frost indicated that safety and tolerability data for MDX2001 should be available by the fourth quarter, with efficacy signals expected in 2026. The hematologic cancer program is in the pre-IND phase.

Q: Are there concerns about government changes affecting vaccine prospects and funding? A: Phillip Frost stated that there are no current indications of concern, and they maintain close contact with contracting officers. The focus remains on preparedness for pandemics and endemic phenomena.

Q: What is the status of the HIV monoclonal antibody program? A: Gary Nabel, Chief Innovation Officer, reported progress with a second-generation, more potent antibody. Discussions with partners are ongoing to advance the program.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.