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]

Core Insights - ModeX Therapeutics has initiated a Phase 1/2a clinical trial for MDX2004, a first-in-class trispecific antibody-fusion protein aimed at treating advanced cancers and immune disorders [1][3] - MDX2004 is designed to stimulate T cells through three signaling pathways, enhancing immune activation and potentially rejuvenating cellular immunity [2][5] - The drug targets patients with advanced solid tumors, addressing the limited treatment options and low long-term survival rates associated with current therapies [3] Company Overview - ModeX Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative multispecific biologics for cancer and infectious diseases [7] - The company utilizes a platform called ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines that target multiple disease pathways simultaneously [6] - ModeX is a subsidiary of OPKO Health, which is a multinational biopharmaceutical and diagnostics company aiming to establish leading positions in rapidly growing markets [8] Product Details - MDX2004 is a trispecific antibody-fusion protein that targets CD3, CD28, and 4-1BB on human T cells, promoting the expansion of stem and memory T cell populations [5] - The drug aims to restore immune function in patients with underlying immune impairments due to aging, chronic diseases, infections, or chemotherapy [5] - Preclinical proof-of-concept data and clinical dose selection analyses for MDX2004 will be presented at the SITC Annual Meeting in November 2025 [4]