OPKO Health(OPK)

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OPKO Health to Participate in the 3rd Annual Piper Sandler Virtual Obesity Symposium
Globenewswire· 2025-06-25 15:00
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]
OPKO Health and Entera Bio Abstract for First-in-Class Dual GLP-1/Glucagon Tablet Candidate for Patients with Obesity and Metabolic Disorders Selected for Presentation at the ENDO 2025 Annual Meeting
Globenewswire· 2025-06-25 12:00
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].
OPKO Health’s ModeX Therapeutics Announces Formation of Scientific Advisory Board with Leaders at the Forefront of Immunology and Oncology Drug Development
Globenewswire· 2025-06-09 12:00
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]
OPKO Health (OPK) 2025 Conference Transcript
2025-06-04 16:05
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.
OPKO Health(OPK) - 2025 FY - Earnings Call Transcript
2025-05-20 14:00
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]
OPKO Health to Participate in Two Upcoming Investor Conferences
GlobeNewswire News Room· 2025-05-15 12:00
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 ...
OPKO Health(OPK) - 2025 Q1 - Quarterly Report
2025-05-01 20:04
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025. OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-33528 OPKO Health, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 75-2402409 (State or Ot ...
OPK Stock Slips Following Q1 Earnings Miss, Gross Margin Expands
ZACKS· 2025-05-01 17:45
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]
OPKO Health (OPK) Reports Q1 Earnings: What Key Metrics Have to Say
ZACKS· 2025-04-30 23:35
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) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-04-30 22:55
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 ...