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 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]