OPKO Health, Inc. (OPK) Q2 2025 Earnings Call Transcript

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Overview

The earnings call shows positive developments: a strategic sale to Labcorp, promising product development, and cost reduction initiatives. The Q&A highlights growth in NGENLA prescriptions, 4Kscore test sales, and potential for oxyntomodulin in obesity/MASH treatment. The share repurchase program and cash flow positive guidance further boost sentiment. Despite some management ambiguity, the overall outlook is positive, with optimistic guidance and strategic initiatives likely to drive a stock price increase in the short term.

Key Financial Performance

Diagnostics Revenue $101.1 million in Q2 2025, including $24.9 million from oncology assets being sold. This is a decline from $129.4 million in Q2 2024, primarily due to the Labcorp transaction that closed in September 2024.

Non-oncology Business Revenue Steady growth with a 12% increase in 4Kscore test volumes year-over-year.

Diagnostics Total Costs and Expenses $119.3 million in Q2 2025, down from $156 million in Q2 2024. This includes $29.4 million related to oncology assets and $2 million in onetime severance costs. The decline is attributed to cost-saving measures.

Diagnostics Operating Loss Improved to $18.2 million in Q2 2025 from $26.6 million in Q2 2024, driven by reduced costs and expenses.

Pharmaceutical Revenue $55.7 million in Q2 2025, up from $52.8 million in Q2 2024. This increase is due to growth in Spanish and Mexican businesses, partially offset by foreign exchange headwinds in Chile.

Rayaldee Revenue $7.2 million in both Q2 2025 and Q2 2024, with improved margins in 2025 due to lower government rebates.

IP Transfer Revenue $15 million in Q2 2025, up from $12.3 million in Q2 2024. This includes Pfizer profit share of $6.1 million in Q2 2025 compared to $6.3 million in Q2 2024.

BARDA Funding Increased to $6.5 million in Q2 2025 from $5 million in Q2 2024, reflecting expanded program activity for infectious disease antibody programs.

Pharmaceutical Costs and Expenses $84.4 million in Q2 2025, up from $77.6 million in Q2 2024, driven by increased R&D investments.

Pharmaceutical Operating Loss $28.7 million in Q2 2025, compared to $24.8 million in Q2 2024, due to higher R&D spending.

Consolidated Operating Loss Improved slightly to $60 million in Q2 2025 from $61.7 million in Q2 2024, due to better results in Diagnostics, offset by increased R&D investments in Pharmaceuticals.

Net Loss $148.4 million or $0.19 per share in Q2 2025, compared to $10.3 million or $0.01 per share in Q2 2024. The increase is due to a $92 million expense from a convertible note exchange and the absence of a $60 million investment gain recorded in 2024.

Cash Position Approximately $285 million in cash, cash equivalents, and restricted cash as of Q2 2025.

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Operating Highlights

ModeX Phase I clinical trials: ModeX has 2 programs in Phase I clinical trials with 3 more expected to enter the clinic late this year and early 2026.

EBV vaccine partnership with Merck: Phase I data from the EBV vaccine will guide decisions regarding Phase II testing.

OPK-88006 GLP-1/glucagon agonist: Collaboration with Entera Bio to develop an oral tablet formulation for obesity and MASH, with encouraging results in animal models.

4Kscore test FDA approval: FDA approved a supplemental application for the 4Kscore test, enabling its use without digital rectal examination information.

Latin American and Irish pharmaceutical business: Continued strong performance with increasing revenue and expanding margins despite foreign currency headwinds.

4Kscore test market expansion: Over 90% of PSA screening tests in the U.S. are performed by primary care providers, now potential users of the 4Kscore test.

BioReference Health restructuring: Streamlined operations with a pending sale of oncology assets to Labcorp for $225 million, expected to close in Q3 2025.

Cost savings in BioReference: Annualized cost savings of approximately $19 million from workforce reduction and footprint consolidation.

Diagnostics business profitability: Expected to reach cash flow positive and profitability in 2025 after the oncology transaction.

Capital allocation strategy: $200 million stock repurchase program with $141.5 million remaining capacity as of June 30, 2025.

Convertible note exchange: Eliminated over $159 million in principal debt, improving overall debt position.

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Risk or Challenges

BioReference Health restructuring: The company is restructuring and right-sizing BioReference Health to achieve profitability. This includes a reduction in force and footprint consolidation, which has already saved $19 million annually. However, the pending sale of oncology assets to Labcorp and the associated earn-out based on client retention pose risks to achieving financial targets.

Foreign currency headwinds: The Latin American and Irish pharmaceutical units face challenges due to foreign currency fluctuations, which could impact revenue and margins.

Diagnostics business profitability: The Diagnostics segment is operating at a loss, with a $18.2 million operating loss in Q2 2025. While cost-saving measures are in place, achieving cash flow breakeven and profitability remains uncertain.

Pharmaceutical R&D investments: Increased R&D spending, particularly in ModeX development programs, has led to higher costs. This could strain financial resources if expected returns are delayed or not realized.

Convertible note exchange: The company incurred a $92 million expense related to a convertible note exchange, which, while improving the debt position, has significantly impacted net loss for Q2 2025.

Market adoption of NGENLA: The global adoption of the long-acting form of hGH (NGENLA) has been slower than anticipated, which could affect revenue projections and market share.

Regulatory and clinical trial risks: The company is heavily reliant on the success of clinical trials and regulatory approvals for its pipeline products, including the EBV vaccine and GLP-1/glucagon agonist. Delays or failures in these areas could impact strategic objectives.

Operational efficiency post-asset sale: The sale of oncology assets to Labcorp is expected to improve margins, but the transition and integration process could pose operational challenges.

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Guidance & Outlook

Revenue Projections: For the full year 2025, total revenue is expected to be between $640 million and $660 million. Revenue from services is projected at $405 million to $425 million, including $95 million to $105 million from oncology assets. Revenue from products is anticipated to be $160 million to $170 million, and other revenue is expected to range from $65 million to $75 million, including Pfizer profit share of $28 million to $35 million and BARDA support of $30 million to $35 million.

Cost and Expense Projections: Total costs and expenses are expected to be between $835 million and $865 million, excluding $15 million to $20 million of one-time restructuring costs for the Diagnostics business. This includes $125 million to $135 million in expenses related to oncology assets and $120 million to $130 million of research and development spending, partially offset by $30 million to $35 million in BARDA funding. Depreciation and amortization expense is projected to be approximately $90 million.

Profitability Outlook: The remaining BioReference business is expected to reach cash flow positive and profitability during 2025, excluding nonrecurring and noncash items. A $100 million gain on the oncology transaction is anticipated, which will reduce operating expenses and increase operating income in the quarter of the transaction's closure.

Diagnostics Business Outlook: Following the oncology transaction, the remaining BioReference business is expected to achieve cash flow breakeven and positive cash from operations in 2025. The business is also expected to show improving margins through the balance of the year and beyond.

Pharmaceutical Business Outlook: The company is optimistic about Pfizer's efforts to accelerate the global commercialization of NGENLA, with expectations of continued growth in the long-acting hGH market. Additionally, OPKO plans to advance five IND filings within the next 12 months for its GLP-1 glucagon, oncology, immunology, and infectious disease programs.

BARDA Funding: BARDA funding is projected to be $30 million to $35 million for 2025, supporting infectious disease antibody programs and other initiatives.

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Shareholder Return Plan

Common Stock Repurchase Program: OPKO Health has a $200 million common stock repurchase program in place, with $141.5 million remaining capacity as of June 30, 2025. The company repurchased approximately 13.6 million shares during Q2 2025 under this program. This represents more than 13% of the current share count at recent trading ranges.

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Key Q&A

Q:Given that new prescriptions and total prescriptions for NGENLA were up in 2Q, do you expect that the $6.1 million in NGENLA/Genotropin profit share in 2Q was due to lower gross-to-net from co-pay assistance in 1Q carrying over to 2Q? And have you received any insights from Pfizer on 2Q sales?

A:Management observed an improvement in the U.S. market for NGENLA prescriptions and noted strength across all geographic markets. They expect the remainder of the year to return to traditional levels but did not directly address the specific impact of lower gross-to-net from co-pay assistance or insights from Pfizer.

Q:How is EBITDA margin for the Diagnostics business tracking in 2Q versus 1Q? And how are you setting expectations for EBITDA profitability in 3Q and 4Q?

A:Management reported quarter-over-quarter improvements in the Diagnostics segment, with a $18.2 million operating loss in Q2, including $2 million in nonrecurring expenses. They expect cost savings from the oncology transaction closure and aim to achieve cash flow positive status this year.

Q:Can you talk about implications for growth in 4Kscore test sales in the coming quarters?

A:Management noted a 12% growth in 4Kscore test sales year-to-date, with acceleration in July. They expect meaningful upside with the FDA label change, allowing primary care doctors to order the test, and highlighted the test's strong margin profile.

Q:With an increasingly crowded obesity landscape, how do you envision oxyntomodulin differentiating either as an injectable or with the oral formulation of its partner with Entera?

A:Management highlighted oxyntomodulin's differentiation through its impact on FGF21, which has anti-fibrosis properties, and its potential for MASH patients with obesity and diabetes. They also emphasized the convenience of transitioning patients to an oral formulation for long-term weight loss maintenance.

Q:When it comes to proving out oxyntomodulin in the Phase I study, are there endpoints you're envisioning or different patient populations?

A:Management plans to focus on obese patients with biomarker evidence of MASH in Phase I, aiming to assess safety and biomarker efficacy without conducting biopsy studies. They will target patients with liver stiffness, liver fat, and fatty liver conditions.

Q:What’s your estimate of the size in terms of patients both having obesity as well as MASH? And would that be the specific indication you’re going to explore in the Phase I study?

A:Management plans to focus on patients with F2, F3, and F4 stages of MASH in Phase I, involving 100-170 patients. They aim to assess safety signals and biomarker trends rather than definitive efficacy.

Q:What’s the difference between the compounds addressing short bowel syndrome and obesity/MASH?

A:Management explained that the GLP-1/glucagon receptor co-agonist for obesity/MASH is distinct from the GLP-2 compound for short bowel syndrome, which regulates intestinal absorption and addresses unmet needs in malnutrition and short bowel syndrome.

Q:When do you anticipate the short bowel syndrome program to enter clinical study?

A:Management expects the program to enter clinical study next year, depending on FDA and regulatory timelines.

Q:Does your dual agonist have the potential to improve GI side effects and lean muscle mass loss associated with current GLP-1 drugs?

A:Management expressed hope for better GI side effect profiles and potential metabolic benefits but acknowledged uncertainty, emphasizing the need for clinical data to confirm these aspects.

Q:What was the BARDA revenue in the quarter, and what is the guide for BARDA revenue for the year?

A:BARDA revenue for the quarter was $6.5 million, with a full-year guidance of $30-35 million.

Q:Does achieving cash flow breakeven after the oncology deal closure require a higher revenue run rate than the $300 million annualized level?

A:Management stated that achieving cash flow breakeven is not dependent on revenue growth beyond the $300 million annualized level.

Q:What are the capital allocation priorities for the balance sheet cash?

A:Management prioritizes balancing investments in R&D and strengthening the balance sheet. They have allocated $80 million this year for stock buybacks and convertible debt exchanges and plan to continue share repurchases as opportunities arise.

Q:Does the current stock price create urgency for completing the common share repurchase?

A:Management indicated they are authorized to deploy up to $200 million for share repurchases and will use it as the balance sheet allows.

Q:Review of Unclear Management Responses

A:Management avoided directly addressing whether the $6.1 million in NGENLA/Genotropin profit share was due to lower gross-to-net from co-pay assistance in 1Q carrying over to 2Q. They also did not provide specific insights from Pfizer on 2Q sales.

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Earnings Word Cloud

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