MIAMI, April 17, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) plans to report operating and financial results for the three months ended March 31, 2025 after the close of the U.S. financial markets on Wednesday, April 30, 2025. OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on April 30th beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourages participants ...

Core Viewpoint - OPKO Health, Inc. has authorized a $100 million increase to its common stock repurchase program, raising the total capacity to $200 million, reflecting the company's belief that its shares are undervalued and demonstrating confidence in its strategic direction [1][2]. Summary by Sections Stock Repurchase Program - The Board of Directors has approved an increase of $100 million to the existing stock repurchase program, bringing the total to $200 million [1]. - Approximately $41 million of OPKO's common stock has already been repurchased since the program's initiation in July 2024 [1]. Management's Perspective - The CEO, Phillip Frost, stated that the share buyback supports the company's strategy and ongoing pipeline advancements while aiming for profitability in the diagnostic segment [2]. - The company plans to repurchase shares through various methods, including open market purchases and block trades, without any obligation to repurchase a specific number of shares [2]. Financial Position - OPKO expects to fund the repurchase program using existing cash and future cash flows, with approximately 671.6 million shares outstanding as of February 24, 2025 [3]. - The total repurchase authorization represents about 14% of the outstanding shares at the current stock price [3]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its proprietary technologies and expertise in discovery, development, and commercialization [4].

Labcorp (LH) recently entered into an agreement with OPKO Health, Inc. (OPK) , a multinational biopharmaceutical and diagnostics company, to acquire select assets of the latter’s wholly owned subsidiary, BioReference Health. This acquisition will strengthen Labcorp's position in the oncology industry, expanding its extensive portfolio of diagnostic tests in cancer care. Financial DetailsThe purchase price for the transaction is up to $225 million, including $192.5 million payable at closing and up to $32.5 ...

Financial Position - As of December 31, 2024, the company had cash, cash equivalents, and restricted cash totaling $445.6 million[165]. - Total assets increased to $2,200,212,000 in 2024, up from $2,011,698,000 in 2023, reflecting a growth of 9.4%[508]. - Total liabilities rose to $834,764,000, compared to $622,479,000 in 2023, marking an increase of 34.0%[508]. - Cash and cash equivalents significantly increased to $431,936,000 from $95,881,000, representing a growth of 350.5%[508]. - The company’s cash, cash equivalents, and restricted cash at the end of the period stood at $445.615 million, a significant increase from $95.881 million at the beginning of the period[519]. Revenue and Profitability - Total revenues for 2024 decreased to $713,142,000, down 17.4% from $863,495,000 in 2023[510]. - Revenue from services was $480,667,000, a decline of 6.7% compared to $515,275,000 in 2023[510]. - The company reported a net loss of $53.224 million for the year ended December 31, 2024, compared to a net loss of $188.863 million in 2023, indicating a significant improvement[519]. - The company reported a comprehensive loss of $71,324,000 for 2024, compared to a comprehensive loss of $183,570,000 in 2023[513]. Regulatory and Compliance Risks - The company is required to comply with extensive regulatory standards, including CLIA and ISO certifications, which could delay production and lead to fines if not met[196]. - The company must maintain compliance with current Good Manufacturing Practices (cGMP) regulations, which include quality control and assurance requirements[257]. - The company is subject to numerous federal and state regulations, including anti-kickback laws and false claims laws, which could lead to penalties if not complied with[260]. - The company faces potential civil or criminal penalties for non-compliance with laws and regulations, which could significantly impact its financial condition and operations[262]. - The company is subject to scrutiny regarding the handling and disposal of medical waste, with potential fines and penalties for non-compliance[268]. Clinical and Product Development - The success of the company's product candidates is uncertain, with risks of failure in clinical trials and regulatory approvals[171]. - The FDA approved NGENLA (Somatrogon (hGH-CTP)) for the treatment of pediatric GHD in June 2023, but commercial success in the U.S. is uncertain[179]. - The global phase 3 trial for Somatrogon (hGH-CTP) met its primary endpoint of non-inferiority to daily Genotropin® for injection, showing higher height standard deviation scores at six and twelve months[178]. - The company has secured regulatory approvals for Somatrogon (hGH-CTP) in over 50 markets, including the U.S. and EU, indicating strong market expansion potential[522]. Funding and Financial Challenges - The company may require additional funding, which may not be available on acceptable terms, potentially impacting its operations and clinical trials[166]. - The company has a history of operating losses and may not achieve profitability in the near future, with limited revenue from proprietary pharmaceutical products[164]. - The company may face significant dilution if it raises additional funds through equity securities[170]. - The company completed a private offering of $250 million aggregate principal amount of senior secured notes on July 17, 2024[168]. Market and Competitive Risks - The company faces risks from competitors developing more effective or less expensive products, which could negatively impact revenues and profitability[187]. - The introduction of generic competitors could significantly impact the company's revenues and profitability, as they typically offer lower-priced alternatives[208]. - The healthcare industry is experiencing consolidation, leading to fewer but larger insurance plans with increased bargaining power over clinical testing providers[221]. Management and Operational Risks - The departure of the Chairman and CEO, Phillip Frost, could have a material adverse effect on the company's business and financial condition due to his reputation and role in attracting business opportunities[204]. - The company relies on third-party manufacturers for its products, and any failure in their performance could lead to significant operational disruptions and financial losses[209]. - The complexity of billing for laboratory testing services may lead to revenue losses if not managed properly, including potential penalties and recoupments from payors[214]. Legal and Cybersecurity Risks - The company has faced legal actions and government investigations that could result in substantial monetary damages and negatively impact its reputation and funding[246]. - The company has implemented cybersecurity measures, but remains vulnerable to evolving cyber threats that could impact its operations and reputation[219]. - Cybersecurity threats to the company's IT systems could disrupt operations and lead to unauthorized access to confidential information, adversely affecting business operations[218]. International Operations and Currency Risks - The company is subject to risks associated with currency fluctuations, which can adversely affect margins on international sales and overall financial performance[290]. - The company operates in a politically and economically unstable environment in Israel, which may adversely affect its operations and revenue[288]. - The company’s international business is subject to various laws and regulations, and failure to comply could result in administrative, civil, or criminal liabilities[295]. Shareholder and Equity Information - Approximately 55.46% of the company's outstanding voting securities are beneficially owned by directors, executive officers, and principal stockholders, with Phillip Frost owning about 36.97%[302]. - As of January 31, 2025, there is a significant short position of approximately 88,641,089 shares, representing about 13.2% of the outstanding Common Stock, which could exert downward pressure on the stock price[303].

Core Insights - OPKO Health, Inc. reported earnings per share (EPS) of $0.01 in Q4 2024, a significant improvement from a loss of $0.09 in the same period last year and better than the Zacks Consensus Estimate of a loss of $0.11 [1][2] - The company’s full-year 2024 loss per share was $0.08, narrower than the loss of $0.25 expected by analysts [2] Revenue Performance - OPKO Health's revenues for Q4 2024 were $183.6 million, reflecting a year-over-year increase of 0.9% and exceeding the Zacks Consensus Estimate by 18.4% [3] - Full-year revenues for 2024 totaled $713.1 million, down 17.4% from 2023 but still beating the Zacks Consensus Estimate by 4.2% [3] Segment Analysis - In the Diagnostics segment, service revenues were $103.1 million, down 16.9% year-over-year due to lower clinical test volumes [5] - The Pharmaceuticals segment saw product revenues decline by 13% to $37.4 million, impacted by unfavorable foreign currency exchange rates [6] - Revenues from the transfer of intellectual property and other sources surged by 193.2% to $43.1 million, driven by milestone payments related to clinical trials [7] Margin and Expense Analysis - Gross profit for the quarter increased by 89.3% to $84.6 million, with gross margin expanding by 2150 basis points to 46.1% [8] - Selling, general, and administrative expenses decreased by 8.1% to $67 million, while research and development expenses rose by 56.7% to $30.4 million [8] Financial Position - OPKO Health ended 2024 with cash and cash equivalents of $431.9 million, a significant increase from $95.9 million at the end of 2023 [11] Future Guidance - For 2025, OPKO Health expects total revenues between $675 million and $700 million, with the Zacks Consensus Estimate at $675.2 million [12] - The company anticipates service revenues to be between $405 million and $425 million, product sales between $165 million and $175 million, and other revenues between $80 million and $95 million [13] Overall Assessment - The company demonstrated better-than-expected results in Q4 2024, with strong revenue growth from intellectual property transfers and improved gross margins [14] - However, lower revenues from products and services, particularly the decline in RAYALDEE sales, raised concerns [16]

Core Insights - OPKO Health reported revenue of $183.6 million for the quarter ended December 2024, reflecting a year-over-year increase of 0.9% and surpassing the Zacks Consensus Estimate of $155.14 million by 18.35% [1] - The company achieved an EPS of $0.01, a significant improvement from -$0.09 in the same quarter last year, resulting in an EPS surprise of 109.09% against the consensus estimate of -$0.11 [1] Revenue Breakdown - Revenue from the transfer of intellectual property and other sources was $43.10 million, exceeding the average estimate of $14.89 million by analysts, marking a year-over-year increase of 193.2% [4] - Revenue from products was reported at $37.40 million, which fell short of the average estimate of $42.96 million, representing a year-over-year decline of 13% [4] - Revenue from services amounted to $103.10 million, slightly above the estimated $97.29 million, but showed a year-over-year decrease of 17% [4] Stock Performance - OPKO Health's shares have returned +10.7% over the past month, contrasting with a -2.2% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Group 1 - OPKO Health reported quarterly earnings of $0.01 per share, exceeding the Zacks Consensus Estimate of a loss of $0.11 per share, compared to a loss of $0.09 per share a year ago [1] - The earnings surprise for this quarter was 109.09%, following a previous surprise of 130% when the company reported earnings of $0.03 per share against an expected loss of $0.10 per share [2] - The company generated revenues of $183.6 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 18.35%, and showing a slight increase from $181.9 million in the same quarter last year [3] Group 2 - OPKO Health shares have increased approximately 12.9% since the beginning of the year, outperforming the S&P 500's gain of 1.3% [4] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.08 on revenues of $157.35 million, and -$0.26 on revenues of $675.16 million for the current fiscal year [8] - The Medical - Instruments industry, to which OPKO Health belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [9]

Financial Data and Key Metrics Changes - The net income for Q4 2024 was $14 million or $0.01 per diluted share, compared to a net loss of $66.5 million or $0.09 per share for Q4 2023 [35] - Revenue for the Diagnostic segment was $103.1 million for Q4 2024, down from $124.2 million in Q4 2023, primarily due to the LabCorp transaction [30] - Revenue for the Pharmaceutical segment was $80.5 million for Q4 2024, up from $57.7 million in Q4 2023 [32] Business Line Data and Key Metrics Changes - The Diagnostic segment's operating loss improved to $21.7 million in Q4 2024 from $42.3 million in Q4 2023 [31] - The Pharmaceutical segment's revenue from products was $37.4 million, down from $43 million in Q4 2023, while revenue from the transfer of IP increased to $43.1 million from $14.7 million [32][33] - The urology segment saw a 16% growth in test volume and revenue for 2024 compared to 2023 [26] Market Data and Key Metrics Changes - The Latin America and Europe Pharmaceutical divisions experienced a 9% growth compared to 2023, despite foreign exchange headwinds [26] - The oncology testing segment finalized nine new hospital reference account contracts, resulting in a 5% growth in net revenues compared to Q4 2023 [25] Company Strategy and Development Direction - The company is focused on advancing its Pharmaceutical pipeline, including the ModeX programs and partnerships to drive value [11][19] - A restructuring of BioReference Health is ongoing to improve financial and operational performance, including reducing expenses and workforce [23][24] - The company anticipates a total revenue of $675 million to $700 million for 2025, with a focus on operational efficiencies and cost reductions [41][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the prospects for 2025, expecting it to be a year of progress across all business segments [12] - The company is optimistic about the continued support for its vaccine and antibody programs, despite potential changes in government funding [102][110] Other Important Information - The company ended 2024 with approximately $495 million in cash and equivalents, with plans for stock buybacks and operational cash utilization [36] - The company expects to incur additional non-recurring costs of $4 million to $8 million in Q1 2025 related to restructuring [40] Q&A Session Summary Question: Timeline for BioReference profitability - Management indicated a path to breakeven in Q1 2025, with profitability expected thereafter, despite some charges related to restructuring [48][49] Question: EBV Phase 2 milestone - Management noted that results from the Phase 1 study could be available in Q2 2025, with potential Phase 2 milestones to be determined thereafter [52][54] Question: Details on dual agonist with Entera Bio - The dual agonist is being developed in both injectable (weekly) and oral (daily) forms, targeting diabetic and obese patients [59][60] Question: Launch of RAYALDEE in China - The initial launch by Nicoya is expected to be small, with broader expansion following NDA approval [64] Question: BARDA funding timeline - Management clarified that the BARDA funding of $40 million to $48 million is expected in 2025, with additional funding contingent on meeting milestones [70][72] Question: Update on HIV monoclonal program - Progress has been made on a second-generation HIV monoclonal antibody, which is more potent than the first generation and is in discussions for advancement [115] Question: MDX2001 trial patient selection criteria - The trial will include a broad patient population, as TROP2 and c-MET are widely expressed in various solid tumors [121][122]

Financial Performance - Consolidated total revenues for Q4 2024 were $183.6 million, a slight increase from $181.9 million in Q4 2023, with net income of $14.0 million compared to a net loss of $66.5 million in the prior year[3] - The operating loss for Q4 2024 was $33.1 million, an improvement from the operating loss of $69.1 million in Q4 2023[3] - Total revenues for the three months ended December 31, 2024, were $183.6 million, a slight increase from $181.9 million in the same period of 2023[14] - Operating loss narrowed to $33.1 million compared to a loss of $69.1 million in the same quarter last year[14] - Net income for the three months was $14.0 million, a recovery from a loss of $66.5 million in the previous year[14] - Basic income per share improved to $0.02 from a loss of $0.09 year-over-year[14] Revenue Breakdown - Revenue from pharmaceuticals in Q4 2024 was $37.4 million, down from $43.0 million in Q4 2023, primarily due to unfavorable foreign currency exchange fluctuations[3] - Revenue from services decreased to $103.1 million from $124.2 million year-over-year, representing a decline of approximately 16.8%[14] - Revenue from products also declined to $37.4 million from $43.0 million, a decrease of about 13.0%[14] - Revenue from the transfer of intellectual property increased significantly to $43.1 million from $14.7 million, marking a growth of approximately 194.5%[14] - Revenue from the transfer of intellectual property and other increased to $43.1 million in Q4 2024 from $14.7 million in Q4 2023, driven by a $23.8 million revenue from the BARDA contract[3] Expenses and Costs - Total costs and expenses increased to $82.6 million in Q4 2024 from $73.8 million in the prior-year period, primarily due to higher research and development expenses[3] - Total costs and expenses for the three months were $216.7 million, down from $251.0 million in the prior year[14] - Research and development expenses increased to $30.4 million from $19.4 million, reflecting a rise of approximately 56.7%[14] Cash and Financing - Cash, cash equivalents, and current restricted cash totaled $431.9 million as of December 31, 2024, compared to $95.9 million at the end of 2023[12] - The company repurchased $17.0 million of principal convertible notes for $25.0 million and an additional 10.9 million common shares for $16.5 million during Q4 2024[2] Strategic Initiatives - BioReference Health aims for profitability in 2025, having sold a portion of its laboratory testing businesses for $237.5 million to enhance growth and profitability[1] - Enrollment is underway in the Phase 1 trial for the MDX2001 treatment of solid tumor cancers, expected to enroll up to 45 patients[1] - OPKO received $51 million in additional funding under an existing BARDA contract to develop COVID multispecific antibodies and initiate an influenza program[1]

Core Insights - OPKO Health, Inc. reported financial results for Q4 and the full year 2024, highlighting a net income of $14.0 million compared to a net loss of $66.5 million in Q4 2023, indicating a significant turnaround in profitability [2][3][14] - Total revenues for Q4 2024 were $183.6 million, slightly up from $181.9 million in Q4 2023, with a notable increase in revenue from the transfer of intellectual property and other, which rose to $43.1 million from $14.7 million [3][14] - The company achieved a consolidated operating loss of $33.1 million in Q4 2024, an improvement from a loss of $69.1 million in the same quarter of the previous year [3][14] Financial Performance - Revenue from services in Q4 2024 was $103.1 million, down from $124.2 million in Q4 2023, primarily due to lower clinical test volumes following the sale of certain BioReference assets [8][14] - Revenue from products decreased to $37.4 million in Q4 2024 from $43.0 million in Q4 2023, attributed to unfavorable foreign currency exchange fluctuations [3][14] - Total costs and expenses for Q4 2024 were $216.7 million, down from $251.0 million in Q4 2023, reflecting cost-reduction initiatives and asset sales [8][14] Strategic Developments - OPKO's BioReference Health is targeting profitability for 2025 by reducing costs and enhancing productivity through innovation in specialty testing segments [2][3] - The company repurchased $17.0 million of principal convertible notes and 10.9 million common shares for $16.5 million during Q4 2024, part of a broader stock repurchase program [2][3] - OPKO received $51 million in additional funding from BARDA to develop COVID multispecific antibodies and initiate an influenza program, bringing total awarded funds to $110 million [2][3] Cash and Assets - As of December 31, 2024, OPKO reported cash, cash equivalents, and current restricted cash of $431.9 million, a significant increase from $95.9 million in the previous year [11][12] - Total assets increased to $2.2 billion in 2024 from $2.0 billion in 2023, indicating a solid financial position [11][12] Market Position - OPKO continues to leverage its proprietary technologies and partnerships, including a collaboration with Merck for an Epstein-Barr virus vaccine, which has commenced patient dosing in a Phase 1 trial [2][3] - The company is entitled to a share of gross profits from Pfizer's NGENLA, which is now available in all major markets, enhancing its revenue potential [2][3]