[Business Highlights](index=1&type=section&id=Business%20Highlights) OPKO advanced its clinical pipeline, including a Phase 1 Epstein-Barr virus vaccine and immuno-oncology candidates, and received FDA approval for its 4Kscore® Test without DRE, expanding its utility - Merck advanced the Phase 1 trial for the Epstein-Barr virus vaccine candidate, with results expected to inform the decision on Phase 2 studies[1](index=1&type=chunk) - ModeX's immuno-oncology portfolio is advancing, with MDX2001 in Phase 1, MDX2004 expected to enter clinic later in 2025, and MDX2003 trials planned for early 2026[1](index=1&type=chunk) - Preclinical data for OPK-88006, a GLP-1/glucagon dual agonist, showed superior therapeutic benefits on MASH hallmarks compared to semaglutide and survodutide in a mouse model[1](index=1&type=chunk) - The FDA approved a supplemental application for the 4Kscore® Test, allowing its use without digital rectal examination (DRE) information, which is significant as over 90% of PSA screening tests are done by primary care providers who don't routinely perform DREs[4](index=4&type=chunk) - An abstract for an oral GLP-2 tablet for short bowel syndrome, developed with Entera Bio, was selected for presentation at the 2025 ESPEN Congress[4](index=4&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) OPKO's Q2 2025 consolidated revenues decreased to **$156.8 million**, leading to a **$148.4 million** net loss, significantly impacted by a one-time convertible note exchange expense [Consolidated Financials](index=2&type=section&id=Consolidated%20Financials) Q2 2025 consolidated revenue decreased to **$156.8 million**, with net loss widening to **$148.4 million** due to a one-time convertible note exchange expense Q2 2025 Consolidated Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues (in millions) | $156.8 | $182.2 | | Operating Loss (in millions) | $60.0 | $61.7 | | Net Loss (in millions) | $148.4 | $10.3 | | Loss Per Share (in dollars) | $0.19 | $0.01 | - The net loss in Q2 2025 was significantly impacted by a **$91.7 million** non-recurring expense related to a convertible note exchange that closed on April 1, 2025[3](index=3&type=chunk) - The prior-year period (Q2 2024) included a **$60.5 million** unrealized gain in the fair value of GeneDx Holdings Corp., which contributed to the lower net loss in that quarter[3](index=3&type=chunk) [Segment Performance](index=3&type=section&id=Segment%20Performance) Pharmaceuticals segment revenue slightly increased to **$55.7 million**, while Diagnostics revenue decreased to **$101.1 million** due to asset sales, though its operating loss narrowed Pharmaceuticals Segment Performance (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Revenue from products (in millions) | $40.7 | $40.5 | | Revenue from IP & other (in millions) | $15.0 | $12.3 | | **Total Revenue (in millions)** | **$55.7** | **$52.8** | | Operating Loss (in millions) | $28.7 | $24.8 | Diagnostics Segment Performance (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Revenue from services (in millions) | $101.1 | $129.4 | | Operating Loss (in millions) | $18.2 | $26.6 | - The decrease in Diagnostics revenue was primarily due to lower clinical test volume resulting from the sale of certain BioReference assets[7](index=7&type=chunk) [Financial Position and Corporate Actions](index=2&type=section&id=Financial%20Position%20and%20Corporate%20Actions) OPKO held **$285.4 million** in cash, exchanged **$159.2 million** in convertible notes, and authorized an additional **$100 million** for its stock repurchase program - Cash, cash equivalents, and restricted cash stood at **$285.4 million** as of June 30, 2025[7](index=7&type=chunk) - In Q2 2025, OPKO exchanged **$159.2 million** of outstanding convertible notes for **121.4 million shares** of common stock and approximately **$63.5 million** in cash[7](index=7&type=chunk) - The Board of Directors authorized an additional **$100 million** for its common stock repurchase program, increasing the total capacity to **$200 million**. As of June 30, 2025, **$58.5 million** had been repurchased[4](index=4&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements detail OPKO Health's financial position as of June 30, 2025, with total assets of **$1,973.0 million** and total liabilities of **$676.1 million**, alongside operational results [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, OPKO Health's total assets were **$1,973.0 million**, with total liabilities decreasing to **$676.1 million** due to reduced convertible notes Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $271.7 | $431.9 | | Total current assets | $583.3 | $662.1 | | **Total Assets** | **$1,973.0** | **$2,200.2** | | Total current liabilities | $171.2 | $193.1 | | Long-term portion of convertible notes | $80.5 | $173.6 | | **Total Liabilities** | **$676.1** | **$834.8** | | **Total Equity** | **$1,296.9** | **$1,365.4** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, OPKO reported total revenues of **$156.8 million** and a net loss of **$148.4 million**, with six-month revenues at **$306.8 million** and a net loss of **$216.1 million** Condensed Consolidated Statement of Operations (in millions) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $156.8 | $182.2 | | Total costs and expenses | $216.8 | $243.9 | | Operating loss | $(60.0) | $(61.7) | | Other income (expense), net | $(102.5) | $51.1 | | **Net loss** | **$(148.4)** | **$(10.3)** | Condensed Consolidated Statement of Operations (in millions) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $306.8 | $355.9 | | Operating loss | $(127.1) | $(133.1) | | **Net loss** | **$(216.1)** | **$(92.1)** |

Core Insights - OPKO Health, Inc. reported its business highlights and financial results for Q2 2025, indicating ongoing advancements in its clinical trials and product development [1][5]. Business Highlights - Merck is advancing a Phase 1 trial for an Epstein-Barr virus vaccine in collaboration with OPKO, evaluating safety and tolerability in 200 healthy adults [1]. - ModeX is progressing its immuno-oncology and immunology portfolio, with multiple clinical candidates, including MDX2001, which is in Phase 1 trials [1]. - OPKO presented promising preclinical data for OPK-88006, a dual agonist for treating metabolic disorders, showing superior therapeutic benefits compared to competitors [1]. - The FDA approved a supplemental application for the 4KScore® Test, allowing it to be performed without digital rectal examination information, enhancing its accessibility for prostate cancer assessment [1]. Financial Results - Total revenues for Q2 2025 were $156.8 million, down from $182.2 million in Q2 2024, with a net loss of $148.4 million, or $0.19 per share, compared to a net loss of $10.3 million, or $0.01 per share, in the prior year [5][13]. - Revenue from product sales was $40.7 million, slightly up from $40.5 million in Q2 2024, while revenue from services decreased to $101.1 million from $129.4 million [5][13]. - The company authorized an additional $100 million for its stock repurchase program, bringing the total capacity to $200 million, representing approximately 14% of OPKO's common shares outstanding [2]. Cash and Assets - As of June 30, 2025, OPKO had cash, cash equivalents, and restricted cash totaling $285.4 million [5]. - The company completed an exchange agreement to purchase $159.2 million of outstanding convertible notes for shares and cash [5].

Core Viewpoint - OPKO Health, Inc. is set to report its operating and financial results for the second quarter and first half of 2025 on July 31, 2025, after U.S. market close [1] Group 1: Financial Reporting - The financial results will cover the three and six months ended June 30, 2025 [1] - A conference call and live audio webcast will be held on July 31 at 4:30 p.m. Eastern time to discuss the results and provide financial guidance [1] Group 2: Conference Call Information - Participants are encouraged to pre-register for the conference call to receive a unique PIN for immediate access [2] - Those unable to pre-register can join by dialing specific numbers for U.S. and international participants [2] Group 3: Replay Information - A telephone replay of the conference call will be available until August 7, 2025, with specific dialing instructions provided [3] - A webcast replay will be accessible approximately one hour after the live call [3] Group 4: Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its expertise and proprietary technologies [4]

Core Insights - OPKO Health and Entera Bio announced a first-in-class oral GLP-2 analog for treating Short Bowel Syndrome (SBS), selected for a poster presentation at the ESPEN Congress in September 2025 [1][2] Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [6] - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology for significant unmet medical needs [5] Product Development - The oral GLP-2 tablet program combines OPKO's long-acting GLP-2 agonist with Entera's N-Tab™ technology, aimed at patients with SBS and related gastrointestinal disorders [2] - Current approved therapy for SBS, GATTEX (teduglutide), generates approximately $800 million in annual sales and requires daily subcutaneous injections [4] Market Context - Short Bowel Syndrome affects around 30,000 patients in the US and EU, leading to malabsorption and increased risk of malnutrition [4] - The introduction of an oral tablet format for GLP-2 therapy may improve patient compliance and enable personalized treatment [3]

Group 1 - OPKO Health, Inc. announced its participation in the 3rd Annual Piper Sandler Obesity Symposium, which will be held virtually on June 26, 2025 [1] - Management will engage in a fireside discussion moderated by Edward Tentoff, a Managing Director and Senior Biotechnology Analyst [1] - Investors interested in the symposium can register by contacting their Piper Sandler representative [1] Group 2 - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in large, rapidly growing markets [2] - The company leverages its expertise in discovery, development, and commercialization, along with novel and proprietary technologies [2]

Core Viewpoint - OPKO Health and Entera Bio are advancing the development of an oral treatment, OPK-88006, for obesity and metabolic disorders, with new pharmacologic data to be presented at the ENDO 2025 annual meeting [1][2]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [5]. - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology to address significant unmet medical needs [4]. Product Development - OPK-88006 is a dual agonist GLP-1/glucagon peptide being developed as both a once-daily oral tablet and a weekly injectable treatment [2][3]. - The oral formulation aims to provide a simpler titration process and improved tolerability for patients, with a focus on sustainable weight loss to mitigate comorbidities like severe fatty liver and sleep apnea [3]. - Both companies plan to file an Investigational New Drug application with the U.S. FDA for OPK-88006 later this year, with Phase 1 clinical studies in preparation [3]. Clinical Trials and Research - The upcoming presentation at the ENDO 2025 meeting will showcase in vivo pharmacokinetic and pharmacodynamic results for OPK-88006 [4]. - Entera's advanced product candidate, EB613, is also in development as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis, with a Phase 2 study already meeting its endpoints [4].

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 ...