Core Insights - Greenberg Traurig, P.A. received the 2025 Beacon Award in the Professional Services category, recognizing its contributions to the Greater Miami economy [1][2] Company Contributions - The firm has played a significant role in enhancing Miami's reputation as a global business hub through transformative business and real estate deals [3] - Greenberg Traurig has supported business expansion with high-impact deals, including a $225 million oncology asset sale for OPKO Health Inc. and a $3.3 billion deal for Vertical Bridge [4][5] - The firm has been involved in landmark projects such as the $5.5 billion recapitalization of Brightline and nearly $2 billion in condo construction loan closings for Related Group [5] Community Engagement - Greenberg Traurig has contributed over 8,400 pro bono hours in the past 3½ years, supporting local charitable and civic organizations [6] - The firm's attorneys hold leadership roles in various nonprofits, demonstrating a commitment to community empowerment [7] Firm Overview - Greenberg Traurig has more than 3,000 attorneys across 51 locations globally, recognized for its innovative legal services and philanthropic efforts [8]

Core Insights - OPKO Health, Inc. (OPK) is positioned for growth due to the potential of its product RAYALDEE, which has shown solid sales momentum and is supported by strategic partnerships [1][4][7] - The company has a market capitalization of $1.17 billion and anticipates a 37.8% growth for fiscal 2026, with earnings surpassing estimates in two of the last four quarters [2][4] - OPKO's stock has gained 2.8% this year, contrasting with a 5.3% decline in the industry and a 15.5% increase in the S&P 500 [1] Factors Favoring OPK Stock - RAYALDEE is the first FDA-approved therapy for treating secondary hyperparathyroidism in adults with chronic kidney disease and vitamin D insufficiency, maintaining strong sales due to effective distribution [4][10] - The product generated $7.2 million and $13.5 million in net product revenue for the three and six months ended June 30, 2025, respectively, with improved profit margins noted [5] - Strategic partnerships, such as the collaboration with Entera Bio for obesity treatment and the sale of BioReference's oncology diagnostics business to Labcorp, aim to streamline operations and strengthen the balance sheet [6][8] Clinical Trials and Pipeline Progress - OPKO's ModeX Therapeutics is advancing with ongoing Phase 1 programs, including an Epstein-Barr virus vaccine and a tetraspecific antibody for solid tumors, with further trials expected to commence by late 2025 or early 2026 [9] - BARDA has expanded funding for ModeX's multispecific antibody programs targeting COVID-19 and influenza to $110 million [9] Estimate Trends - The Zacks Consensus Estimate for OPKO's loss has remained stable at 37 cents per share for 2025, with third-quarter 2025 revenue estimates at $157.1 million, indicating a 9.5% decline from the previous year [11]

MIAMI, Oct. 22, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) plans to report operating and financial results for the three and nine months ended September 30, 2025 after the close of the U.S. financial markets on Wednesday, October 29, 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 October 29th beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourag ...

OPKO Health, Inc. (NASDAQ: OPK ) continues to evolve itself and its operations. It has been losing money for some time and is undertaking changes to bring itself closer to profitability. The company is reducing its labAnalyst’s Disclosure:I/we have a beneficial long position in the shares of OPK either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no busines ...

Core Insights - OPKO Health, Inc. is a diversified healthcare company involved in diagnostics, pharmaceuticals, and innovative therapies, with a focus on immuno-oncology and metabolic disorders [1] - The company has seen significant insider buying in 2025, indicating strong confidence from key shareholders in its long-term prospects [2] Company Developments - CEO Phillip Frost, the largest shareholder with approximately 31% ownership, has participated in recent share purchases, increasing the top five holders' combined ownership to 51% [2] - OPKO is advancing a Phase 1 Epstein-Barr virus vaccine in collaboration with Merck, with potential Phase 2 trials starting next year [3] - The ModeX division is innovating in immuno-oncology with four candidates in the pipeline, including MDX2001, currently in Phase 1 trials [3] Product Pipeline - OPKO is addressing obesity through a collaboration with Entera Bio on OPK-88006, an oral dual GLP-1/glucagon agonist, with promising results presented at ENDO 2025 [4] - The company is developing both oral and injectable formulations to meet the increasing demand for obesity treatments [4] Financial Performance - OPKO reported Q2 2025 revenue of $156.8 million, a decline from the previous year, but is projected to achieve revenues of $640–$660 million for 2025 [5] - The recent sale of select oncology testing assets to Labcorp aims to streamline operations and improve liquidity [5] - The company is focusing on its pipeline, cost savings, and strategic divestitures to enhance margins and move towards profitability [5]

Core Insights - Opko Health reported a significant revenue miss in Q2 2025, with total GAAP revenue of $156.8 million, falling short of analyst expectations of $165.7 million [1] - The company experienced a net loss per share of $0.19, wider than the estimated loss of $0.11 and significantly higher than the prior year's figure [1][2] - The results were impacted by lower diagnostics revenues due to asset sales, flat pharmaceutical product revenues, and a one-time charge related to a convertible note exchange [1] Financial Performance - Q2 2025 GAAP revenue was $156.8 million, down 14.0% from $182.2 million in Q2 2024 [2] - Diagnostics revenue fell to $101.1 million, a decrease of 21.8% from $129.4 million in Q2 2024 [2][5] - Pharmaceutical revenue remained nearly flat at $40.7 million, compared to $40.5 million in Q2 2024 [2][6] - The company recognized a $91.7 million nonrecurring charge related to convertible notes, impacting the net loss significantly [8] Business Overview - Opko Health operates in two main areas: pharmaceutical products and diagnostics services, with a focus on therapies for chronic kidney disease, hormonal disorders, and infectious diseases [3] - The diagnostics unit, BioReference, provides medical laboratory testing, including specialized cancer screening [3] Recent Developments - The company has been streamlining operations through asset sales and cost reductions, particularly in the diagnostics business [4] - The FDA approved a supplemental application for the 4Kscore test, which is expected to expand access to more physicians [7] - The diagnostics segment continues to face revenue pressure after recent asset divestitures, with expectations of further revenue reduction upon the anticipated sale of oncology testing assets to Labcorp [10] Financial Outlook - Management maintained its full-year 2025 revenue guidance of $675 million to $685 million, indicating expectations for stronger performance in the second half of the year [11] - Full-year 2025 costs and expenses are guided to be between $825 million and $875 million [11] - The company is focusing on returning to profitability in core diagnostics and pharmaceutical operations, with ongoing cost reduction initiatives expected to save $10 million annually [12]

Core Insights - OPKO Health, Inc. reported a loss per share of 19 cents in Q2 2025, which is wider than the previous year's loss of 1 cent and the Zacks Consensus Estimate of a loss of 12 cents [2][11] - The company's revenues for the second quarter were $156.8 million, reflecting a 13.9% year-over-year decline and missing the Zacks Consensus Estimate by 5.1% [3][11] Revenue Breakdown - Revenues from the Diagnostics segment amounted to $101.1 million, down 21.9% year-over-year, primarily due to lower clinical test volumes following the sale of certain BioReference assets [5] - In the Pharmaceuticals segment, product revenues increased by 0.6% year-over-year to $40.7 million, driven by higher sales volumes in international operations, although offset by reduced sales in Chile [6] - Revenue from the transfer of intellectual property and other reached $14.9 million, up 21.6% year-over-year, attributed to higher revenue from the BARDA contract [8] Margin and Expense Analysis - Gross profit decreased by 4.4% year-over-year to $49.4 million, but gross margin improved by 315 basis points to 31.5% [9][11] - Selling, general and administrative (SG&A) expenses fell by 13.4% year-over-year to $59.6 million, while research and development expenses rose by 25.9% to $30.3 million [9] Financial Position - At the end of Q2 2025, OPKO Health had cash and cash equivalents of $271.7 million, down from $435.9 million at the end of Q1 2025 [12] - Cumulative net cash used in operating activities increased to $117.9 million compared to $62 million a year ago [12] Guidance and Outlook - OPKO Health revised its 2025 revenue outlook to a range of $640 million to $660 million, down from a previous estimate of $675 million to $685 million [13] - Expected revenues from product sales are now projected between $160 million and $170 million, and revenues from services are anticipated to be in the range of $405 million to $425 million [14] Additional Developments - OPKO Health's ModeX is advancing its immuno-oncology and immunology portfolio with four potential clinical candidates, and the FDA approved a supplemental application for the 4KScore Test [16]

Core Insights - OPKO Health reported $156.8 million in revenue for the quarter ended June 2025, reflecting a year-over-year decline of 13.9% and an EPS of -$0.19 compared to -$0.01 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $165.22 million by 5.09%, and the EPS was also below the consensus estimate of -$0.12, resulting in a surprise of -58.33% [1] Revenue Breakdown - Revenue from the transfer of intellectual property and other was $15 million, below the five-analyst average estimate of $20.07 million, but showed a year-over-year increase of 22% [4] - Revenue from products was $40.7 million, slightly below the estimated $40.88 million, with a year-over-year change of 0.5% [4] - Revenue from services was $101.1 million, which was lower than the estimated $104.29 million, representing a significant year-over-year decline of 21.9% [4] Stock Performance - OPKO Health's shares have remained unchanged over the past month, while the Zacks S&P 500 composite increased by 2.7% [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance compared to the broader market in the near term [3]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $101.1 million, down from $129.4 million in Q2 2024, primarily due to the LabCorp transaction [20] - Total costs and expenses decreased to $119.3 million from $156 million year-over-year, contributing to an improved diagnostic operating loss of $18.2 million compared to $26.6 million in Q2 2024 [21] - Net loss for Q2 2025 was $148.4 million, or $0.19 per share, compared to a net loss of $10.3 million, or $0.01 per share, in Q2 2024 [26] Business Line Data and Key Metrics Changes - Diagnostics revenue included $24.9 million from oncology assets, with non-oncology business showing steady growth, particularly a 12% increase in 4Kscore volumes [20][21] - Pharmaceutical revenue increased to $55.7 million from $52.8 million in the previous year, driven by growth in Spanish and Mexican markets [22] - R&D expenses rose to $29.8 million from $23.7 million, reflecting increased investments in MODEX development programs [25] Market Data and Key Metrics Changes - BioReference's testing volume grew by 1.4% in 2025 compared to the previous year, with the 4Kscore test volume increasing approximately 12% year-over-year [13][20] - The Latin American business and Irish Contract Pharmaceutical Development and Manufacturing Unit continued to perform well, with increasing revenue and expanding margins despite foreign currency headwinds [7] Company Strategy and Development Direction - The company is focused on maximizing shareholder value through strategic capital deployment, partnerships, and asset sales, with a $200 million stock repurchase program in place [7][8] - The sale of oncology assets to LabCorp is expected to enhance BioReference's focus on core testing operations and improve financial performance [5][9] - The company aims to achieve cash flow breakeven and positive cash from operations in 2025, with expectations for the remaining BioReference business to reach profitability [21][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic initiatives and operational efficiencies being implemented, which are expected to yield significant cost savings [21][28] - The company anticipates closing the LabCorp transaction later this year, which will provide substantial cash inflow and further enhance operational focus [27][28] - Management highlighted the importance of ongoing R&D investments and collaborations to drive future growth, particularly in the pharmaceutical segment [25][73] Other Important Information - The FDA granted approval for a supplemental application for the 4Kscore test, which is expected to open new market opportunities [12] - The company has sufficient capital to support R&D efforts, with funding from strategic partners and non-dilutive sources [7] Q&A Session Summary Question: Insights on ANGELLA prescriptions and profit share - Management noted improvements in U.S. market prescription trends and expects sales to pick up in the remainder of the year [30][32] Question: EBITDA margin tracking and growth expectations - Management indicated ongoing improvements in the Diagnostics segment and expects to achieve cash flow positive status this year [33][34] Question: Differentiation of obesity treatment efforts - Management highlighted the unique metabolic benefits of their GLP-one glucagon receptor dual agonist and the convenience of oral formulations [39][41] Question: Size of patient population for obesity and NASH - Management confirmed focus on patients with biomarkers indicating obesity and NASH for upcoming Phase I studies [47][48] Question: BARDA revenue and future capital allocation - BARDA revenue for the quarter was $6.5 million, with expectations of $30 million to $35 million for the year [61][62] - Management discussed plans for capital allocation, emphasizing R&D investments and share repurchase programs [64][66]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited condensed consolidated financial statements and notes detail its financial position, performance, cash flows, accounting policies, debt, and strategic alliances [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The company's financial position reflects decreased total assets and revenues, a significantly widened net loss in Q2 2025, and increased cash used in operating activities Condensed Consolidated Balance Sheet Highlights (As of June 30, 2025) | Metric | June 30, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and current restricted cash | 271,718 | 431,936 | | Total current assets | 583,333 | 662,089 | | Total assets | 1,972,989 | 2,200,212 | | Total current liabilities | 171,181 | 193,096 | | Total liabilities | 676,085 | 834,764 | | Total shareholders' equity | 1,296,904 | 1,365,448 | Condensed Consolidated Statement of Operations Highlights | Metric | Q2 2025 ($ thousands) | Q2 2024 ($ thousands) | H1 2025 ($ thousands) | H1 2024 ($ thousands) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | 156,807 | 182,186 | 306,759 | 355,872 | | Operating loss | (59,981) | (61,670) | (127,148) | (133,143) | | Net loss | (148,441) | (10,305) | (216,054) | (92,141) | | Loss per share, basic and diluted | (0.19) | (0.01) | (0.31) | (0.13) | Condensed Consolidated Statement of Cash Flows Highlights (Six Months Ended June 30) | Metric | 2025 ($ thousands) | 2024 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (117,974) | (62,001) | | Net cash provided by (used in) investing activities | 37,694 | (11,557) | | Net cash (used in) provided by financing activities | (83,511) | 18,498 | | Net decrease in cash, cash equivalents and restricted cash | (160,220) | (55,305) | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail healthcare operations, oncology diagnostics sale, debt exchanges, strategic alliances, and a material tax assessment contingency - The company entered into an agreement with Labcorp to sell its oncology diagnostics business for up to **$225 million**, with the transaction expected to close in the second half of 2025, and these assets are now classified as held for sale[32](index=32&type=chunk)[33](index=33&type=chunk) - In April 2025, the company exchanged **$159.2 million** of its 2029 Convertible Notes for **121.4 million shares** of common stock and **$63.5 million** in cash, resulting in a total charge of **$91.7 million**[116](index=116&type=chunk) - The collaboration with BARDA was expanded, increasing the total contract value to **$110.0 million**, with a potential value of up to **$205 million** if all options are exercised, recognizing **$13.5 million** in revenue for H1 2025[187](index=187&type=chunk)[191](index=191&type=chunk) - A significant legal contingency exists with the Israel Tax Authority, which issued an assessment of approximately **$246 million** against a subsidiary, which the company is appealing[146](index=146&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=64&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 and H1 2025 financial results, highlighting revenue decline from divestitures, a widened net loss, and sufficient liquidity for the next 12 months [Results of Operations](index=65&type=section&id=Results%20of%20Operations) Q2 2025 consolidated revenues decreased **14%** due to Diagnostics divestitures, Pharmaceuticals revenue grew **6%**, and the net loss significantly widened primarily from increased interest expense Consolidated Results of Operations (Q2 2025 vs. Q2 2024) | Metric (in thousands) | Q2 2025 | Q2 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $156,807 | $182,186 | $(25,379) | (14)% | | Loss from operations | $(59,981) | $(61,670) | $1,689 | 3% | - Diagnostics segment revenue decreased by **21.9%** in Q2 2025, primarily due to the absence of revenue from lab operations sold to Labcorp in September 2024, though its operating loss improved by **32%** to **$18.2 million** due to cost reductions and divestiture[245](index=245&type=chunk) - Pharmaceuticals segment revenue increased by **6%** in Q2 2025, driven by a **22%** rise in intellectual property revenue from the BARDA contract and commercial milestones, but operating loss widened by **16%** to **$28.7 million** due to increased R&D expenses[252](index=252&type=chunk)[253](index=253&type=chunk) - Interest expense for Q2 2025 surged to **$70.3 million** from **$8.2 million** in Q2 2024, mainly due to the amortization of **$54.7 million** in unamortized debt discount and **$4.4 million** in debt issuance costs from the Note Exchange Transactions[261](index=261&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$285.4 million** in cash, with management deeming liquidity sufficient for over 12 months, supported by asset sales and potential milestones - The company held **$285.4 million** in cash, cash equivalents, and restricted cash as of June 30, 2025, with cash used in operations for H1 2025 at **$118.0 million**[291](index=291&type=chunk) - The company expects to receive up to **$225 million** in cash from the sale of its oncology business to Labcorp, expected to close in the second half of 2025[294](index=294&type=chunk) - Significant potential future cash inflows include up to **$860.0 million** in milestones from the Merck agreement and up to **$275.0 million** from the Pfizer agreement, in addition to tiered royalties[303](index=303&type=chunk)[304](index=304&type=chunk) Contractual Obligations as of June 30, 2025 (in thousands) | Obligation Type | Total | Due in < 1 Year | Due in 1-3 Years | Due in 3-5 Years | Due Thereafter | | :--- | :--- | :--- | :--- | :--- | :--- | | Debt (Notes, Mortgages, Lines of Credit) | $344,793 | $14,921 | $1,131 | $80,416 | $248,325 | | Operating & Finance Leases | $52,465 | $6,075 | $10,283 | $6,742 | $29,365 | | Open Purchase Orders | $32,740 | $27,366 | $5,374 | $0 | $0 | | Interest Commitments | $16,530 | $2,368 | $9,322 | $4,840 | $0 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=83&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign currency exchange rates, with **24.5%** of H1 2025 revenue in foreign currencies, and interest rates, managed through short-term investments - Foreign currency risk is significant, with **24.5%** of revenue in H1 2025 denominated in currencies other than the USD, primarily the Chilean Peso and Euro, mitigated by foreign exchange forward contracts[319](index=319&type=chunk)[322](index=322&type=chunk) - Interest rate risk exposure relates to **$285.4 million** in cash/investments and **$12.5 million** outstanding on variable-rate lines of credit, managed by maintaining short-term maturities for investments[323](index=323&type=chunk)[324](index=324&type=chunk) [Item 4. Controls and Procedures](index=84&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[327](index=327&type=chunk) - There were no changes to the company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[328](index=328&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=84&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's legal matters, including an appeal against a **$246 million** tax assessment and a 5-year Corporate Integrity Agreement - The company is appealing a tax assessment of approximately **$246 million** issued by the Israel Tax Authority against its subsidiary, OPKO Biologics[146](index=146&type=chunk) - The company and its subsidiary BioReference are subject to a 5-year Corporate Integrity Agreement (CIA) with the OIG-HHS, effective July 2022, to resolve an investigation into past billing practices[147](index=147&type=chunk)[149](index=149&type=chunk) [Item 1A. Risk Factors](index=84&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to its risk factors from those previously disclosed in its Annual Report and Q1 2025 Form 10-Q - There have been no material changes to the company's risk factors from those previously disclosed[330](index=330&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q2 2025, the company repurchased **13.6 million shares** for **$18.3 million** under a **$200 million** program, with **$141.5 million** remaining Share Repurchase Activity (Q2 2025) | Period | Total Shares Purchased | Average Price Paid per Share | Total Cost (approx.) | | :--- | :--- | :--- | :--- | | May 2025 | 9,646,344 | $1.31 | $12.6M | | June 2025 | 4,000,000 | $1.36 | $5.4M | | **Total Q2** | **13,646,344** | **$1.34** | **$18.3M** | - The stock repurchase program was increased by **$100.0 million** on April 4, 2025, bringing the total authorized amount to **$200 million**, with **$141.5 million** remaining available for repurchase as of June 30, 2025[331](index=331&type=chunk) [Other Disclosures (Items 3, 4, 5, 6)](index=84&type=section&id=Other%20Disclosures%20%28Items%203%2C%204%2C%205%2C%206%29) This section confirms standard corporate disclosures, including no defaults on senior securities, no mine safety disclosures, and no Rule 10b5-1 trading plan changes - The company reported no defaults upon senior securities[332](index=332&type=chunk) - No officers or directors adopted or terminated a Rule 10b5-1 trading plan during the quarter ended June 30, 2025[335](index=335&type=chunk)