Core Insights - ModeX Therapeutics Inc., a subsidiary of OPKO Health, has established a Scientific Advisory Board to enhance its immunology and oncology pipeline, focusing on multispecific antibodies and vaccines [1][3][9] - The board consists of prominent scientists recognized for their contributions to biomedical research and therapeutic advancements [2][4][5] Company Overview - ModeX is a clinical-stage biopharmaceutical company developing proprietary multispecific therapeutics using its MSTAR platform, which allows for the creation of antibodies that can target four or more disease pathways [9] - The company is focused on addressing complex diseases, including various forms of cancer and immune-mediated diseases, with a promising pipeline of first-in-class drugs [1][8][9] Scientific Advisory Board - The founding members of the board include Drs. John Heymach, Ronald Levy, Myron Cohen, and Rafi Ahmed, all of whom are leaders in their respective fields [2][4][6] - The board aims to guide ModeX in advancing next-generation immune therapies that can target multiple disease pathways simultaneously [3][5] Multispecific Therapeutics - Multispecific therapeutics are positioned as the future of medicine, addressing the limitations of traditional single-target therapies by combining multiple biological targets [8] - ModeX's approach aims to revolutionize treatment options for patients suffering from complex and previously untreatable conditions [8][9]

Summary of OPKO Health Conference Call Company Overview - **Company**: OPKO Health - **Founded**: 1991 by Phil Frost - **Business Segments**: - Pharmaceutical business with revenue in Latin America and the U.S. (Engenla, a growth hormone product partnered with Pfizer) - Diagnostic services including the BioReference laboratory, one of the top 10 labs in the U.S. - Pharmaceutical discovery through Modex Therapeutics, focusing on multi-specific antibodies and vaccine platforms [3][4][5] Recent Developments - **Sale to LabCorp**: - Announced a second sale of oncology-related diagnostics for $192.5 million upfront, with an additional potential earn-out of $32.5 million [6][7] - The sale aims to streamline operations and enhance profitability, focusing on the core profitable areas in New York and New Jersey [8][9] Financial Performance - **Revenue Insights**: - The company reported $520 million in revenue, with $300 million from core operations in New York and New Jersey [7][8] - The remaining diagnostics business is expected to be profitable starting now and through 2025, driven by consolidation efforts and high-margin tests [9][10] - **Valuation Multiples**: - The company anticipates trading multiples for the remaining diagnostics business to be in the range of 2 to 3 times revenue [12][13] Growth Hormone Collaboration with Pfizer - **Revenue Shortfall**: - Reported $4.5 million in revenue for the growth hormone product Anjenla, lower than the expected $9.6 million due to higher copay assistance costs [16][17] - **Future Expectations**: - Pfizer estimates Anjenla could reach $500 million to $1 billion in peak sales, with OPKO's profit share expected to grow to the mid-20% range as the franchise expands [19][20] Modex Therapeutics Updates - **Clinical Trials**: - Plans to show clinical safety updates for a tetra-specific antibody by the end of 2025, with ongoing trials focusing on specific cancer targets [22][24] - The partnership with Merck for an EBV vaccine is progressing well, with a milestone payment expected upon moving to phase two [27][49] Pipeline and Future Programs - **New Drug Developments**: - Introduction of a dual GLP-1/glucagon agonist for obesity and NASH, with an IND expected later this year [58][60] - The drug aims to differentiate itself by having direct action on the liver and promoting anti-fibrotic effects [59][62] Financial Position and Cash Runway - **Cash Reserves**: - Ended the first quarter with approximately $450 million in cash, excluding the expected $192 million from LabCorp [76][77] - **Use of Funds**: - Plans to allocate $100 million for R&D and another $100 million for stock buybacks [76][77] Government Funding - **BARDA Funding**: - Received $59 million last year and $51 million this year for developing multi-specific antibodies against COVID and flu, which significantly supports R&D budgets [80][81] Regulatory Interactions - **FDA Engagement**: - Positive interactions with the FDA regarding COVID programs, with timely responses and no significant delays reported [82] This summary encapsulates the key points discussed during the OPKO Health conference call, highlighting the company's strategic direction, financial performance, and future growth prospects.

Financial Data and Key Metrics Changes - The company ended March 31 with approximately $450 million in cash and cash equivalents, expecting to use about $100 million for operations and another $100 million for capital and convertible note repurchases this year [40][41] - The pharmaceutical products business experienced a slight decline, attributed to timing issues with government tenders in Latin America, but growth is expected to resume throughout the year [9][12] Business Line Data and Key Metrics Changes - BioReference Laboratories underwent two transactions with LabCorp, aimed at reducing operational footprint and focusing on high-value businesses like oncology, which is performing well [3][5] - The oncology diagnostic business is expected to continue growing, with the company emphasizing the importance of scale in operations [4][6] Market Data and Key Metrics Changes - The company anticipates a growth rate of about 8% for its Latin American business and low single-digit growth for the remaining business piece after divestitures [12][13] - The gross profit share from Pfizer has shown some softness, but the company remains optimistic about future growth due to ongoing product launches and label expansions [11][12] Company Strategy and Development Direction - The company is focusing on driving growth and profitability in BioReference, with a strategic shift towards oncology and other high-value segments [6][12] - There is an emphasis on developing differentiated technologies in immuno-oncology, including a tetra antibody that targets multiple markers on cancer cells [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the pharmaceutical products and the oncology business, despite recent declines [8][9] - The company is actively managing its cash position to support ongoing operations and R&D, with plans to continue stock repurchases [40][41] Other Important Information - The company is collaborating with Merck on an Epstein Barr virus vaccine, currently in Phase 1 trials, with promising initial results [34][35] - A new GLP-1 glucagon dual agonist is in development, with a focus on addressing obesity and weight management, leveraging innovative delivery methods [23][24] Q&A Session Summary Question: What is the rationale behind the transactions with LabCorp? - The transactions aim to reduce operational footprint and focus on high-value businesses like oncology, which is performing well [3][5] Question: Do you expect sales of pharmaceutical products to resume growth? - Yes, growth is expected for the full year despite a slight decline in the first quarter due to timing issues and market dynamics [8][9] Question: What are the main drivers for top-line revenue growth in the next 12 to 18 months? - Growth is anticipated from the Latin American business and the remaining operations of BioReference, with an overall guidance of about 8% growth [12][13] Question: What is the current status of the tetra antibody in immuno-oncology? - The tetra antibody is in clinical trials, with expectations to demonstrate efficacy by the end of the year [18][21] Question: How is the company positioned financially to support its programs? - The company has a strong cash position and plans to utilize funds for operations, R&D, and stock repurchases [40][41]

Contacts: Alliance Advisors IR Yvonne Briggs, 310-691-7100 ybriggs@allianceadvisors.com or Bruce Voss, 310-691-7100 bvoss@allianceadvisors.com H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq, May 20 in New York City. Management will hold one-on-one meetings with investors and will participate in a fireside discussion at 9:00 a.m. Eastern time. Jefferies Global Healthcare Conference, June 3-5 at the Marriott Marquis in New York City. Management will hold one-on-one meetings with investors ...

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]