Revenue Performance - Total revenues for the three months ended March 31, 2025, were $149.95 million, a decrease of 14% compared to $173.69 million for the same period in 2024[238]. - Revenue from services decreased by approximately $24.1 million, or 19%, primarily due to the absence of revenue from divested BioReference lab operations and lower clinical test volumes[239]. - Revenue from products for Q1 2025 decreased by $3.2 million or 8.4% to $34.8 million compared to Q1 2024, primarily due to unfavorable foreign exchange fluctuations and a reduction in Rayaldee sales[245]. - Revenue from the transfer of intellectual property increased by $3.5 million to $12.3 million in Q1 2025, driven by $7.0 million recognized under the BARDA Contract[246]. - Total revenues for Q1 2025 were $47.1 million, a slight increase of 1% compared to $46.8 million in Q1 2024[245]. Financial Loss and Expenses - The company recorded a loss from operations of $67.17 million for the three months ended March 31, 2025, an improvement of 6% compared to a loss of $71.47 million in the same period of 2024[238]. - Research and development expenses increased by 41% to $30.84 million for the three months ended March 31, 2025, compared to $21.94 million in 2024[238]. - Research and development expenses rose by 42.3% to $30.2 million in Q1 2025, primarily due to increased expenses at ModeX and growth in BARDA collaboration[249]. - Selling, general and administrative expenses decreased by 15.5% to $12.7 million in Q1 2025, attributed to lower employee-related expenses[248]. Cash and Investments - The company had cash, cash equivalents, and restricted cash of approximately $449.7 million as of March 31, 2025[260]. - Cash, cash equivalents, and restricted cash amounted to $449.7 million as of March 31, 2025[287]. - The weighted average interest rate for cash, cash equivalents, and restricted cash was approximately 6.2% for the three months ended March 31, 2025[287]. - The principal outstanding balance under Chilean and Spanish lines of credit was $10.7 million at a weighted average interest rate of approximately 5.5%[287]. - The company aims to preserve principal while maximizing yields without significantly increasing risk through investments in high-quality debt instruments[289]. - Investments are maintained at an average maturity of generally less than three months to minimize exposure to adverse shifts in interest rates[289]. Stock and Shareholder Actions - The company announced a stock repurchase program increase of $100 million, bringing the total capacity to $200 million, with $40.2 million spent on repurchasing 25,825,785 shares at an average price of $1.56[230]. - The company announced a $100 million increase to its stock repurchase program, bringing the total capacity to $200 million[261]. Collaborations and Agreements - The company entered into a collaboration agreement with Entera Bio Ltd. to develop an oral dual agonist GLP-1/glucagon peptide for obesity and metabolic disorders, with a 60% ownership interest in the program[232][233]. - The company is expected to receive up to $225 million from Labcorp for the sale of BioReference's oncology assets, including $192.5 million in cash at closing[235]. - The company entered into an agreement to acquire BioReference's oncology and related clinical testing services assets for up to $225 million, expected to close in the second half of 2025[263]. - Under the Merck Agreement, ModeX received an initial payment of $50.0 million and is eligible for up to an additional $860.0 million upon achieving certain milestones, including a $12.5 million milestone payment triggered by the dosing of the first participant in a Phase 1 study[271]. - The company has received or is eligible for up to $275.0 million under the Restated Pfizer Agreement, including $90 million triggered by FDA approval in the U.S. and $85 million from the commencement of sales of NGENLA in Europe and Japan[271]. Regulatory Approvals and Product Development - The company has secured regulatory approvals for Somatrogon (hGH-CTP) in over 50 markets, including the U.S. and EU, and is marketed under the brand name NGENLA®[226]. - ModeX entered into a BARDA Amendment in September 2024, increasing funding by $26.9 million for the development of a next-generation MSTAR multispecific antibody, raising the total BARDA Contract value to $110.0 million, with a potential value of $205.0 million if all options are exercised[267]. Foreign Currency and Risk Management - Approximately 22.3% of the company's revenue for the three months ended March 31, 2025, was denominated in currencies other than the U.S. Dollar, compared to 21.5% in the same period of 2024[236]. - The company held 60 open foreign exchange forward contracts as of March 31, 2025, to mitigate foreign currency transaction risk[237]. - Gross accumulated currency translation adjustments totaled $41.6 million at March 31, 2025, down from $52.7 million at December 31, 2024[285]. Debt and Obligations - The total contractual obligations due by period as of March 31, 2025, amount to $580.9 million, with $70.8 million due in the remaining nine months of 2025[274]. - The company has a total of $250 million in 2044 Notes secured by profit share payments from Pfizer, maturing in July 2044, with interest-only payments required for the first four years[269]. Accounting and Financial Standards - ModeX is currently evaluating the potential impact of new accounting standards issued by the FASB, including ASU 2024-03 and ASU 2023-09, which will affect future financial disclosures[276][277].

Core Viewpoint - OPKO Health, Inc. reported a narrower loss per share of 10 cents in Q1 2025 compared to a loss of 12 cents in the same period last year, but this was wider than the Zacks Consensus Estimate of a loss of 6 cents per share [1][13] Revenue Summary - OPKO Health's total revenues for Q1 2025 were $149.9 million, reflecting a 13.7% decrease year over year and missing the Zacks Consensus Estimate by 8.9% [1][2] - Revenues from the Diagnostics segment amounted to $102.8 million, down 18.9% year over year, primarily due to lower clinical test volume [4] - In the Pharmaceuticals segment, revenues from products declined 8.7% year over year to $34.8 million, impacted by unfavorable foreign currency exchange and decreased Rayaldee sales [5] - Revenues from the transfer of intellectual property increased by 41.4% year over year to $12.3 million, driven by a significant rise in BARDA contract revenues [6] Margin Analysis - Gross profit increased by 1.4% year over year to $42.6 million, with gross margin expanding by 424 basis points to 28.4% [7] - Selling, general and administrative expenses decreased by 15.8% year over year to $59.1 million, while research and development expenses rose by 40.6% to $30.8 million [7][8] Financial Position - OPKO Health ended Q1 2025 with cash and cash equivalents of $436 million, slightly up from $431.9 million at the end of 2024 [9] Guidance - The company revised its 2025 revenue outlook to a range of $675 million to $685 million, down from a previous range of $675 million to $700 million [11] - Product sales are expected to be between $165 million and $175 million, while other revenues are now projected to be between $75 million and $85 million [12] Recent Developments - OPKO Health signed an agreement with Labcorp to sell oncology-related clinical testing assets and entered a collaboration with Entera Bio for an oral GLP-1/glucagon tablet candidate [15] - ModeX Therapeutics Inc., a subsidiary of OPKO, is advancing its immuno-oncology and immunology portfolio with four clinical candidates [15]

Core Insights - OPKO Health reported a revenue of $149.9 million for the quarter ended March 2025, which is a decrease of 13.7% compared to the same period last year [1] - The company's EPS was -$0.10, an improvement from -$0.12 in the year-ago quarter [1] - The reported revenue fell short of the Zacks Consensus Estimate of $164.48 million, resulting in a surprise of -8.87% [1] - The EPS surprise was -66.67%, with the consensus EPS estimate being -$0.06 [1] Revenue Breakdown - Revenue from services was $102.80 million, slightly above the estimated $102.66 million, but represents a decline of 19% year-over-year [4] - Revenue from the transfer of intellectual property and other sources was $12.30 million, significantly lower than the estimated $22.16 million, but shows a year-over-year increase of 41.4% [4] - Revenue from products was $34.80 million, below the estimated $39.64 million, reflecting an 8.7% decrease compared to the previous year [4] Stock Performance - OPKO Health's shares have returned -15.7% over the past month, contrasting with the Zacks S&P 500 composite's -0.2% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it may perform in line with the broader market in the near term [3]

OPKO Health (OPK) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to loss of $0.12 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -66.67%. A quarter ago, it was expected that this holding company with investments in pharmaceutical and diagnostics companies would post a loss of $0.11 per share when it actually produced earnings of $0.01, delivering a surpr ...

Financial Data and Key Metrics Changes - The company reported a net loss of $67.6 million or $0.10 per share for Q1 2025, compared to a net loss of $81.8 million or $0.12 per share for the same period in 2024, indicating an improvement in financial performance [25] - Total revenues for 2025 are expected to be between $675 million and $685 million, with costs and expenses projected between $825 million and $875 million, excluding nonrecurring expenses related to restructuring [31][32] - Operating loss for the Diagnostics segment was $23.9 million in Q1 2025, an improvement from an operating loss of $34.4 million in Q1 2024 [21] Business Line Data and Key Metrics Changes - Diagnostics segment revenue was $102.8 million for Q1 2025, down from $126.9 million in Q1 2024, primarily due to the sale of assets to LabCorp [20] - The Pharmaceutical segment revenue increased to $47.1 million in Q1 2025 from $46.8 million in Q1 2024, with product revenue slightly decreasing to $34.8 million from $38.1 million [22] - BioReference's 4Kscore test reported a 14.5% growth year over year, indicating strong performance in its core testing capabilities [12] Market Data and Key Metrics Changes - The company anticipates that the remaining BioReference business will generate approximately $320 million in revenue for 2024 after the sale of the oncology business [12] - The foreign currency environment has impacted revenue, but profitability remains stable due to disciplined operating expense management [22] Company Strategy and Development Direction - The company is focused on advancing its strategic initiatives, including the sale of BioReference's oncology business to LabCorp, which is expected to enhance profitability [6][9] - A $100 million increase in the common stock repurchase program was approved, bringing the total to $200 million, reflecting the belief that shares are undervalued [9] - The company is working on operational efficiencies and cost reduction initiatives, targeting an additional $10 million in annualized cost savings [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for BioReference by the end of 2025, following the completion of the LabCorp transaction [30] - The company expects to continue navigating challenges in the pharmaceutical segment, particularly related to foreign currency fluctuations and the competitive landscape [28] Other Important Information - The company ended Q1 2025 with approximately $450 million in cash and cash equivalents, bolstered by the exit from a position in GNDX [26] - A convertible debt exchange was completed, eliminating $159.2 million of outstanding convertible notes [26] Q&A Session Summary Question: What are some possible explanations for the negative dynamics for ENGENLA? - Management indicated that the growth rates for prescriptions continue, suggesting that the issues are likely related to the commercial environment rather than competition [34] Question: Could you provide a rough timeline about the development program of the GLP-one glucagon tablet candidate? - The IND is expected to be filed by the end of this year or early next year, with Phase one trial results anticipated by the end of 2026 [39] Question: What are the next steps for the subcutaneous obesity program and NASH program? - Both programs are in the pre-IND phase, with plans to enter Phase I trials focusing on safety and pharmacological behavior [60] Question: Can you comment on the convertible notes and secured notes? - Approximately $129 million of principal remains outstanding on convertible notes, with pro forma shares increasing to about $790 million [46] Question: What is the expected revenue from BARDA? - The revised guidance for BARDA revenue is now between $38 million and $44 million, down from previous estimates [80]

Financial Data and Key Metrics Changes - The company reported a net loss of $67.6 million or $0.10 per share for Q1 2025, compared to a net loss of $81.8 million or $0.12 per share for the same period in 2024 [24] - Total revenue for Q1 2025 was $149.9 million, a decrease from $173.7 million in Q1 2024, primarily due to the sale of assets to LabCorp [18][20] - Operating loss for Q1 2025 was $58.7 million, compared to an operating loss of $62.1 million in Q1 2024 [24] Business Line Data and Key Metrics Changes - Diagnostics segment revenue was $102.8 million for Q1 2025, down from $126.9 million in Q1 2024, largely due to the LabCorp transaction [18][20] - The Pharmaceutical segment revenue increased slightly to $47.1 million in Q1 2025 from $46.8 million in Q1 2024, with product revenue including international sales at $34.8 million [20] - The 4Kscore test in the Diagnostics segment reported a 14.5% year-over-year growth [10] Market Data and Key Metrics Changes - The company anticipates total revenues for 2025 to be between $675 million and $685 million, with service revenue projected between $400 million and $425 million [29] - Revenue from products is expected to be between $165 million and $175 million, while other revenue, including Pfizer gross profit share, is estimated between $30 million and $40 million [29] Company Strategy and Development Direction - The company is focused on advancing its strategic initiatives, including the sale of BioReference's oncology business to LabCorp, which is expected to enhance profitability [5][9] - A $100 million increase in the common stock repurchase program was approved, bringing the total to $200 million, indicating confidence in the company's undervalued shares [7] - The company aims to reach profitability within the year and is executing a multi-year program to improve operational efficiencies in the Diagnostics segment [12][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive value for shareholders despite challenges in the commercial environment affecting product sales [5][20] - The company expects to incur additional non-recurring costs of $5 million in Q2 2025, primarily related to severance [28] - Management remains optimistic about the progress of its pharmaceutical programs and the potential for profitability in the Diagnostics segment post-LabCorp transaction [18][28] Other Important Information - The company ended Q1 2025 with approximately $450 million in cash and equivalents, having exited its position in GNDX, adding $51 million to its cash balance [25] - The company completed a convertible debt exchange, eliminating $159.2 million of outstanding convertible notes [25] Q&A Session Summary Question: What are some possible explanations for the negative dynamics for ENGENLA? - Management indicated that the growth rates for prescriptions continue, suggesting the issue is likely related to the commercial environment rather than competition [33] Question: Could you comment on why Pfizer withdrew their EU application for the adult setting? - Management noted that Pfizer is focusing on pediatric indications due to the larger market size, which influenced their decision [34] Question: Could you provide a rough timeline about the development program of the GLP-oneglucagon tablet candidate? - The IND is expected to be filed by the end of this year or early next year, with Phase one trial results anticipated by the end of 2026 [37][38] Question: Can you give us a sense of the Diagnostic business and BioReference? - Management confirmed that the remaining business is expected to generate between $310 million and $320 million on an annualized basis [45] Question: What are the next steps for the subcutaneous obesity program and NASH program? - Both programs are in the pre-IND phase, with plans to enter Phase I trials soon, focusing on safety and pharmacological behavior [56][57]

Exhibit 99.1 OPKO Health Reports First Quarter 2025 Business Highlights and Financial Results Conference call begins at 4:30 p.m. Eastern time today MIAMI (April 30, 2025) – OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended March 31, 2025. Highlights from the first quarter of 2025 and recent weeks include the following: ● Signed definitive agreement with Labcorp to sell oncology and related clinical testing assets of BioReference Health (BioReferenc ...

Core Insights - OPKO Health, Inc. reported a consolidated total revenue of $149.9 million for Q1 2025, a decrease from $173.7 million in Q1 2024, with an operating loss of $67.2 million compared to $71.5 million in the previous year [2][3][14] - The company signed a definitive agreement with Labcorp to sell oncology and related clinical testing assets for up to $225 million, expected to close in the second half of 2025 [2] - OPKO entered into a collaboration agreement with Entera Bio to develop an oral GLP-1/glucagon tablet candidate for obesity and metabolic disorders, with OPKO holding a 60% ownership interest [2] - The company authorized an additional $100 million for its common stock repurchase program, increasing the total capacity to $200 million [2] Financial Performance - Total revenues for Q1 2025 were $149.9 million, down from $173.7 million in Q1 2024, with revenues from services at $102.8 million compared to $126.9 million in the prior year [14] - Revenue from products was $34.8 million, a decrease from $38.1 million in Q1 2024, primarily due to unfavorable foreign currency exchange rates and a decline in Rayaldee sales [3][14] - The net loss for Q1 2025 was $67.6 million, or $0.10 per share, compared to a net loss of $81.8 million, or $0.12 per share, in Q1 2024 [14] Operational Highlights - The company is advancing its immuno-oncology and immunology portfolio, with multiple clinical candidates in development, including MDX2001, MDX2003, and MDX2004 [2] - Enrollment and dosing for a Phase 1 Epstein-Barr virus vaccine trial, developed in collaboration with Merck, have commenced [2] - OPKO's cash, cash equivalents, and restricted cash totaled $449.7 million as of March 31, 2025, following the sale of GeneDx shares [8] Strategic Initiatives - The sale of BioReference's oncology assets is part of OPKO's strategy to streamline operations while maintaining core clinical testing services, which generated approximately $300 million in revenue for 2024 [2] - The collaboration with Entera Bio aims to leverage OPKO's proprietary technology to address obesity and metabolic disorders, indicating a focus on innovative therapeutic solutions [2] - The company continues to pursue share repurchase programs as part of its capital allocation strategy, reflecting confidence in its long-term value [2]

MIAMI, April 17, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) plans to report operating and financial results for the three months ended March 31, 2025 after the close of the U.S. financial markets on Wednesday, April 30, 2025. OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on April 30th beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourages participants ...

Core Viewpoint - OPKO Health, Inc. has authorized a $100 million increase to its common stock repurchase program, raising the total capacity to $200 million, reflecting the company's belief that its shares are undervalued and demonstrating confidence in its strategic direction [1][2]. Summary by Sections Stock Repurchase Program - The Board of Directors has approved an increase of $100 million to the existing stock repurchase program, bringing the total to $200 million [1]. - Approximately $41 million of OPKO's common stock has already been repurchased since the program's initiation in July 2024 [1]. Management's Perspective - The CEO, Phillip Frost, stated that the share buyback supports the company's strategy and ongoing pipeline advancements while aiming for profitability in the diagnostic segment [2]. - The company plans to repurchase shares through various methods, including open market purchases and block trades, without any obligation to repurchase a specific number of shares [2]. Financial Position - OPKO expects to fund the repurchase program using existing cash and future cash flows, with approximately 671.6 million shares outstanding as of February 24, 2025 [3]. - The total repurchase authorization represents about 14% of the outstanding shares at the current stock price [3]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its proprietary technologies and expertise in discovery, development, and commercialization [4].