Key Takeaways OPKO Health is positioned for growth with RAYALDEE performance and multiple partnership-driven initiatives.RAYALDEE maintained sales strength supported by rebates, discounts and broad U.S. distribution channels.Clinical programs advanced with new oncology, vaccine and metabolic trials and continued data presentations.OPKO Health, Inc. (OPK) is well-poised for growth in the coming quarters, supported by the potential of RAYALDEE. The optimism surrounding the stock is backed by RAYALDEE’s perfor ...

Core Insights - OPKO Health, Inc. will participate in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025, in New York City [1] - Management will hold one-on-one meetings with investors and participate in a fireside discussion on December 3 at 12:00 p.m. Eastern time [1] Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in large, rapidly growing markets [3] - The company leverages its discovery, development, and commercialization expertise along with novel and proprietary technologies [3]

Core Insights - Opko Health Inc. (NASDAQ:OPK) is identified as one of the best stocks under $5 with significant upside potential [1] - ModeX Therapeutics Inc., a subsidiary of Opko Health, has entered into a collaboration with Regeneron Pharmaceuticals for the development of multispecific antibodies [2] Collaboration Agreement - The agreement includes an upfront payment of USD $7 million to ModeX, with potential future payments exceeding USD $200 million per selected molecule [3] - The overall value of the collaboration could exceed $1 billion if multiple products are successful, with ModeX also eligible for tiered global net sales royalties [4] Company Overview - Opko Health Inc. operates in the biopharmaceutical and diagnostics sectors, providing healthcare services through its Diagnostics and Pharmaceuticals segments [5]

Core Insights - OPKO Health, Inc. reported earnings per share of 3 cents for Q3 2025, exceeding the Zacks Consensus Estimate of a loss of 2 cents by 250% [1][10] - Total revenues for the quarter were $151.7 million, a decrease of 12.6% year over year, and fell short of the Zacks Consensus Estimate by 3.4% [2][10] Revenue Breakdown - Revenues from the Diagnostics segment amounted to $95.2 million, down 21.5% year over year, primarily due to lower clinical test volumes [4] - In the Pharmaceuticals segment, product revenues declined 3.6% year over year to $37.7 million, with Rayaldee sales increasing by 29.3% to $7.5 million [5] - Revenues from the transfer of intellectual property and other sources totaled $18.8 million, up 42.2% year over year, driven by higher BARDA contract revenues [6] Margin and Expense Analysis - Gross profit increased 24.4% year over year to $49.9 million, with gross margin expanding by 980 basis points to 32.9% [7][10] - Selling, general and administrative expenses decreased by 45.2% year over year to $53.8 million, while research and development expenses rose by 4.5% to $30.1 million [7] Financial Position - OPKO Health ended Q3 2025 with cash and cash equivalents of $428.9 million, up from $271.7 million at the end of Q2 2025 [9] - Cumulative net cash used in operating activities was $152.6 million, compared to $139.1 million a year ago [11] Future Guidance - For Q4 2025, OPKO expects total revenues between $135 million and $140 million, with product sales projected at $40-$45 million and service revenues at $70-$75 million [12] Strategic Outlook - The company is focusing on operational progress and strategic realignment, particularly in its Diagnostics and Therapeutics segments [13] - The sale of BioReference Health's oncology division has allowed for a sharper focus on core clinical testing and the 4Kscore prostate cancer test [13] - OPKO is advancing its pipeline through ModeX, with collaborations with Regeneron, Merck, and BARDA enhancing its R&D funding [14][15]

Core Insights - OPKO Health reported revenue of $151.7 million for the quarter ended September 2025, a decrease of 12.6% year-over-year, and EPS remained unchanged at $0.03 compared to the same quarter last year [1] - The revenue fell short of the Zacks Consensus Estimate of $157.11 million, resulting in a surprise of -3.44%, while the EPS exceeded expectations with a surprise of +250% against a consensus estimate of -$0.02 [1] Revenue Breakdown - Revenue from services was $95.2 million, below the average estimate of $96.86 million, reflecting a year-over-year decline of 21.5% [4] - Revenue from the transfer of intellectual property and other sources reached $18.8 million, slightly above the estimated $18.46 million, marking a significant increase of 42.4% year-over-year [4] - Revenue from products totaled $37.7 million, which was lower than the average estimate of $41.79 million, indicating a year-over-year decrease of 3.6% [4] Stock Performance - Over the past month, OPKO Health's shares have returned -7.1%, contrasting with the Zacks S&P 500 composite's increase of +3.8% [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for outperformance in the near term [3]

Financial Data and Key Metrics Changes - OPKO Health reported Q3 2025 revenue of $95.2 million, down from $121.3 million in Q3 2024, primarily due to the sale of oncology assets to LabCorp [22] - Total costs and expenses decreased to $115.2 million from $184.2 million year-over-year, including $25.2 million related to sold oncology assets [22] - Diagnostic operating income improved to $81.6 million compared to $58.5 million in Q3 2024 [23] - Consolidated operating income rose to $48.1 million from $14.2 million in 2024, with net income of $21.6 million, or $0.03 per share, compared to $24.9 million in Q3 2024 [25] Business Line Data and Key Metrics Changes - BioReference Health's testing volume increased by approximately 5.3% in Q3 2025 compared to the previous year, excluding sold assets [10] - The 4Kscore test volume increased more than 20% in Q3 2025 versus the comparable year-ago period, driven by a recent FDA label expansion [11] - Pharmaceutical revenue was $56.4 million, an 8% increase from $52.4 million in Q3 2024, with product revenue slightly down to $37.7 million [24] Market Data and Key Metrics Changes - International operations provided steady sales growth and meaningful cash flow, despite foreign currency pressures [18] - Viality contributed $7.5 million in Q3 2025, a 29% increase from the previous year, reflecting lower government rebates [24] Company Strategy and Development Direction - The company completed the sale of BioReference Health's oncology division for $192.5 million, focusing on core clinical testing operations and the 4Kscore test [4] - OPKO Health is advancing its pipeline with four candidates in clinical trials and several in pre-IND stages, including collaborations with Regeneron and Merck [5][12] - The company aims to maximize shareholder value through strategic actions, including share repurchase programs and advancing clinical trials [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic direction and ability to deliver on milestones, with expectations for BioReference Health to achieve profitability and growth [19] - The company anticipates total revenue for Q4 2025 to be between $135 million to $140 million, with a focus on improving operating efficiency [26] Other Important Information - The company has $428 million in cash and equivalents, allowing for ongoing operations and development plans [20] - OPKO Health has repurchased nearly 25 million shares for approximately $33.5 million in 2025, with $126 million remaining under the buyback program [20] Q&A Session Summary Question: How many patients have been dosed at the fifth dose level for MDX2001, and will the program proceed to dose level six? - The company has dosed five patients at the fifth dose level and expects to proceed to the next level after the observation period [30][32] Question: Is the growth of the 4Kscore test related to the recent label expansion? - The growth is primarily based on the former label, but the new label is expected to expand the market significantly [34][35] Question: Can you provide more details on the Regeneron collaboration? - The collaboration includes four specific programs across metabolism, oncology, and immunology, with potential for expansion [40][41] Question: What is the expected gross margin for the diagnostic services business? - The gross margin is expected to be in the mid-20% range for Q4, improving to the high 20% to low 30% range in the first half of next year [49] Question: What is the rationale for targeting both CD19 and CD20 in the new product? - Targeting both antigens aims to prevent or delay the emergence of resistant variants, enhancing treatment efficacy [66][70]

Revenue Performance - Total revenues for the three months ended September 30, 2025, were $151.7 million, a decrease of 13% compared to $173.6 million in the same period of 2024[244]. - Revenue from services decreased by approximately $26.0 million, or 21%, primarily due to the sale of BioReference's lab operations and lower clinical test volume[245]. - Total revenues for the three months ended September 30, 2025, increased by $4.1 million or 8% to $56.4 million compared to $52.4 million in 2024[253]. - Total revenues for the nine months ended September 30, 2025, decreased by $71.1 million or 13% to $458.4 million compared to $529.5 million in 2024[268]. - Revenue from services for the nine months ended September 30, 2025, decreased by $78.4 million or 21% to $299.2 million, primarily due to the sale of BioReference's lab operations[269]. - Total revenue for the nine months ended September 30, 2025, was $299.2 million, a decrease of 20.7% from $377.6 million in 2024[271]. - Revenue from products decreased by $1.5 million or 3.7% to $37.7 million, primarily due to lower sales volume in international operations[253]. - Revenue from products decreased by $4.4 million, or 3.8%, primarily due to lower sales volume in international operations[276]. - Revenue from the transfer of intellectual property and other increased by $5.5 million or 42% to $18.7 million, driven by a $2.6 million increase from the BARDA Contract[254]. - Revenue from the transfer of intellectual property increased by $11.7 million, or 34%, driven by a significant increase from the BARDA Contract[277]. Expenses - Selling, general and administrative expenses decreased by 55.6% to $31.5 million for the three months ended September 30, 2025, compared to $70.9 million in 2024[248]. - Selling, general and administrative expenses decreased by $2.1 million or 14% to $13.1 million, mainly due to lower employee-related expenses[256]. - Research and development expenses for the three months ended September 30, 2025, were $0.3 million, a decrease of 41% from $0.5 million in 2024[250]. - Research and development expenses decreased to $1.3 million in 2025 from $1.5 million in 2024, primarily due to reduced employee-related expenses[273]. - Research and development expenses increased by $1.4 million or 5% to $29.6 million, reflecting higher expenses at ModeX and growth in BARDA collaboration[258]. - Cost of revenue for the three months ended September 30, 2025, decreased by 26.1% to $80.4 million, primarily due to the divestiture of certain lab operations[247]. - Cost of revenue decreased by $3.3 million or 13.3% to $21.4 million, attributed to lower sales volume and unfavorable foreign exchange effects[255]. - Cost of revenue decreased by $78.5 million, or 24.1%, primarily due to the divestiture of certain lab operations, which incurred $71.9 million in costs in 2024[271]. Gains and Losses - The company recognized a gain of $101.6 million from the Oncology Transaction for the three and nine months ended September 30, 2025[239]. - Gain on sale of assets was $101.6 million for the nine months ended September 30, 2025, compared to $121.5 million in 2024, attributed to the Oncology and BioReference Transactions[275]. Cash and Investments - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash of approximately $428.9 million[290]. - Cash used in operations for the nine months ended September 30, 2025, was $152.6 million, primarily due to general and administrative expenses, research and development, and sales and marketing activities[290]. - The company received $232.3 million from investing activities, mainly from the Labcorp asset sale, which included $197.8 million in proceeds[290]. - The company sold its entire holding of 620,000 shares of GeneDx common stock for approximately $51.7 million[294]. - The company exchanged $159.2 million of 2029 Convertible 144A Notes for 121.4 million shares of Common Stock and cash payments totaling approximately $63.5 million[293]. - The company authorized an increase of $100.0 million to its Common Stock repurchase program, bringing the total capacity to $200.0 million[292]. Foreign Exchange and Interest - Approximately 25.2% of revenue for the nine months ended September 30, 2025, was denominated in currencies other than the U.S. Dollar, compared to 22.3% in the same period of 2024[242]. - The company held $5.3 million in open foreign exchange forward contracts related to inventory purchases as of September 30, 2025, compared to zero open contracts at the end of 2024[243]. - The company manages foreign currency exchange rate risk through foreign exchange forward contracts, primarily hedging against the Chilean Peso to the U.S. dollar[318]. - Interest income increased to $3.0 million for the three months ended September 30, 2025, compared to $2.9 million in 2024, driven by a larger average balance of cash and cash equivalents[262]. - Interest income increased to $11.0 million in 2025 from $4.1 million in 2024, due to interest earned on a larger cash investment[284]. - Interest expense decreased to $11.4 million for the three months ended September 30, 2025, from $17.4 million in 2024, due to lower interest incurred on convertible notes[263]. - Interest expense rose to $97.2 million in 2025 from $33.2 million in 2024, primarily due to amortization of debt discount and issuance costs[285]. Tax and Obligations - Income tax benefit for the nine months ended September 30, 2025, was $0.1 million, compared to a provision of $21.9 million in 2024, reflecting non-recurring tax expenses related to transactions[288]. - The total contractual obligations due by period as of September 30, 2025, amounted to $423.7 million[308]. Accounting Changes - The company adopted ASU 2024-04 effective January 1, 2025, which clarifies accounting for convertible debt, with no material impact on financial statements[313]. - The company adopted ASU 2023-07 in Q4 of fiscal year 2024, enhancing segment expense disclosures, with no material impact on financial statements[314].

Financial Performance - Total consolidated revenues for Q3 2025 were $151.7 million, down from $173.6 million in Q3 2024, representing a decrease of approximately 12.0%[3] - Operating income for Q3 2025 was $48.1 million, compared to $14.2 million in Q3 2024, indicating a significant improvement[3] - Net income for Q3 2025 was $21.6 million, or $0.03 per diluted share, compared to $24.9 million, or $0.03 per diluted share, in the prior year[3] - Total revenues for the three months ended September 30, 2025, were $151.7 million, a decrease of 12.6% compared to $173.6 million for the same period in 2024[14] - Revenue from services was $95.2 million, down 21.5% from $121.3 million year-over-year[14] - Net income for the three months ended September 30, 2025, was $21.6 million, compared to $24.9 million in the same quarter of 2024, reflecting a decrease of 13.3%[14] - Total costs and expenses for the three months ended September 30, 2025, were $103.6 million, down from $159.4 million in the same quarter of 2024, a decrease of 34.9%[14] Revenue Breakdown - Revenue from pharmaceuticals in Q3 2025 was $37.7 million, a slight decrease from $39.1 million in Q3 2024, while Rayaldee sales increased to $7.5 million from $5.8 million[3] - Revenue from diagnostics services in Q3 2025 was $95.2 million, down from $121.3 million in Q3 2024, primarily due to lower clinical test volumes[3] Cash and Investments - Cash, cash equivalents, and restricted cash totaled $428.9 million as of September 30, 2025, including $173.3 million received from the Labcorp transaction[3][4] - Approximately $73.8 million of OPKO's common stock had been repurchased under the buyback program since its authorization in July 2024, with $126.2 million remaining available for future repurchases[4] - The company reported a loss from investments in investees of $0.0 million, consistent with the previous year[14] Research and Development - Research and development expenses increased to $30.1 million, up 4.5% from $28.8 million in the prior year[14] Collaborations and Approvals - The collaboration with Regeneron Pharmaceuticals could yield potential milestone payments exceeding $200 million for each program, with overall collaboration value potentially exceeding $1 billion[1] - The FDA approved a supplemental application for the 4Kscore® Test, enhancing its use without digital rectal examination information, supported by studies showing over 96% sensitivity and accuracy[2] Stock and Shares - The weighted average common shares outstanding, basic, increased to 777,154,808 from 694,622,466 year-over-year[14] - Income (loss) per share, basic, was $0.03 for the three months ended September 30, 2025, compared to $0.04 for the same period in 2024[14] Cost Management - The cost of service revenues decreased to $80.4 million from $108.8 million, a reduction of 26.1% year-over-year[14]

Core Insights - OPKO Health, Inc. reported business highlights and financial results for Q3 2025, including a collaboration with Regeneron Pharmaceuticals and the sale of BioReference Health assets [1][5]. Business Highlights - OPKO entered a research collaboration with Regeneron to develop multispecific antibodies, potentially exceeding $1 billion in value if multiple products succeed, with an upfront payment and milestone payments exceeding $200 million for each program [1]. - The sale of BioReference oncology assets to Labcorp for $225 million, including $192.5 million at closing and up to $32.5 million in performance-based earnout, aims to streamline operations and enhance profitability [1]. - Merck advanced the Phase 1 trial of an Epstein-Barr virus vaccine, with enrollment progressing well [1]. - The first patient was dosed in the MDX2004 Phase 1/2a study for advanced cancers, with data to be presented at the SITC annual meeting [1]. - Abstracts for various drug candidates, including MDX-2001 and OPK-88006, were presented at major medical conferences, indicating ongoing development in immunotherapy and metabolic disorder treatments [1]. Financial Results - Total revenues for Q3 2025 were $151.7 million, down from $173.6 million in Q3 2024, while operating income increased to $48.1 million from $14.2 million [5][13]. - Net income for Q3 2025 was $21.6 million, or $0.03 per diluted share, compared to $24.9 million, or $0.03 per diluted share, in the prior year [5][14]. - Revenue from products was $37.7 million, a slight decrease from $39.1 million in Q3 2024, while revenue from services dropped to $95.2 million from $121.3 million [5][13]. - Total costs and expenses decreased to $80.6 million in Q3 2025 from $84.6 million in the prior year, primarily due to lower sales volume and reduced employee-related expenses [5][13]. Cash Position - As of September 30, 2025, cash, cash equivalents, and restricted cash totaled $428.9 million, with $173.3 million received from the Labcorp transaction [5][11]. - Approximately $73.8 million of OPKO's common stock had been repurchased under the buyback program, with $126.2 million remaining authorized for future repurchases [5].

Core Insights - ModeX Therapeutics Inc., a subsidiary of OPKO Health, has entered into a collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies targeting various therapeutic areas [1][2][3] Financial Terms - ModeX will receive an upfront payment of USD $7 million, with potential future payments exceeding USD $200 million per selected molecule, and the overall collaboration value could exceed $1 billion if multiple products succeed [2][8] - ModeX is also eligible for tiered global net sales royalties, reaching up to low double digits at the highest tier [2] Collaboration Details - The partnership aims to leverage ModeX's MSTAR platform and Regeneron's proprietary binders to create multispecific antibody candidates that can target multiple biological pathways [1][4] - Regeneron will lead and fund all preclinical and clinical development activities for the products advanced under this collaboration [2][4] Scientific Innovation - ModeX's MSTAR platform enables the development of multispecific antibodies that can address multiple disease pathways simultaneously, which is crucial for treating complex conditions [5] - The collaboration is expected to enhance the therapeutic potential of antibodies in areas such as immunology, oncology, and metabolic diseases [3][4] Company Background - ModeX Therapeutics is focused on developing innovative multispecific biologics for cancer and infectious diseases, with a pipeline that includes candidates for solid and hematologic tumors [6] - OPKO Health is a multinational biopharmaceutical and diagnostics company aiming to establish leading positions in rapidly growing markets through its proprietary technologies [9]