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Here's Why You Should Retain OPKO Health Stock in Your Portfolio

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Key Takeaways

  • OPKO Health expects 33.3% growth for fiscal 2026, supported by Rayaldee and strategic partnerships.
  • OPK partnered with Entera Bio and struck asset deals with Labcorp to streamline and fund expansion.
  • Clinical trials via ModeX and BARDA-backed programs highlight OPK's pipeline beyond Rayaldee.

OPKO Health, Inc. (OPK - Free Report) is well-poised for growth in the coming quarters, courtesy of its potential in RAYALDEE. The optimism surrounding the stock is backed by RAYALDEE’s performance and strategic partnerships. However, stiff competition and overdependence on RAYALDEE pose concerns.     

Shares of this Zacks Rank #3 (Hold) company have lost 8.8% so far this year compared with the industry's 9.7% decline. The S&P 500 has increased 2.1% in the said time frame.

This renowned multinational biopharmaceutical and diagnostics company has a market capitalization of $1.07 billion. The company predicts 33.3% growth for fiscal 2026 and expects to maintain its strong performance. OPKO Health’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average beat being 65.33%.

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Factors Favoring OPK Stock

Potential of RAYALDEE: Rayaldee remains OPKO Health’s flagship renal product in the United States, approved for treating SHPT in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. Distributed primarily through retail pharmacies and major wholesalers, Rayaldee also operates under various rebate and discount agreements with payors and providers. While sales declined recently due to headwinds from the Inflation Reduction Act, OPKO reported improved operating margins driven by better net pricing through reduced government rebates, which helped partially offset the volume decline.

Strategic Agreements: OPKO Health has been active on multiple strategic fronts. In March, the company partnered with Entera Bio to develop a once-daily oral GLP-1/glucagon dual agonist tablet targeting obesity and metabolic disorders, combining OPKO’s OPK-88006 analog with Entera’s N-Tab delivery tech. That same month, OPKO also reached an agreement with Labcorp, which will acquire select oncology and diagnostics assets from OPKO’s BioReference Health. This divestiture, including a similar sale in September 2024, is expected to streamline operations, strengthen focus on the $300 million 4Kscore urology franchise, and potentially raise up to $462.5 million to support business expansion and debt reduction.

Clinical Trials: In its latest earnings call, OPKO Health confirmed that ModeX Therapeutics has two active programs in Phase 1 trials: an Epstein-Barr virus (EBV) vaccine candidate in collaboration with Merck, and MDX2001, a tetraspecific antibody targeting solid tumors, which has progressed to its fourth dose level. Additional Phase 1 and 1b studies in selected solid tumors are expected to begin in early 2026. Human trials for MDX2003 (for lymphoma and leukemia) and MDX2004 (an immune rejuvenator) are planned for late 2025 or early 2026. Meanwhile, the development of multispecific antibodies for immunocompromised patients at risk for COVID-19 and influenza continues, backed by $110 million in BARDA funding.

Factors That May Offset the Gains for OPK

Overdependence on RAYALDEE: OPKO Health's financial success depends heavily on the commercialization of Rayaldee, its only approved pharmaceutical product in the United States. Failure to effectively market Rayaldee could severely affect the company's revenues, profitability and overall business operations.

Additionally, Rayaldee's market reputation, safety and perceived efficacy are crucial. Any negative publicity, safety concerns or rumors about the product could significantly harm OPKO's business, undermining the product's acceptance and damaging its financial outlook.

Currently, reimbursement challenges, increased competition and slower-than-expected market adoption are likely to hurt Rayaldee sales going forward. Moreover, pricing pressures and formulary restrictions, along with shifts in treatment guidelines and generic alternatives, are likely to keep the drug’s sales under pressure.

Stiff Competition: The pharmaceutical, diagnostic, and laboratory testing industries are highly competitive and require an ongoing, extensive search for technological innovation. Numerous companies, including major pharmaceutical companies, specialty pharmaceutical companies and specialized biotechnology companies, are engaged in the development, manufacture and marketing of pharmaceutical products competitive with those that OPKO Health intends to commercialize itself and through its partners.

Competitors to the company’s diagnostics business include major diagnostic companies, reference laboratories, molecular diagnostic firms, universities and research institutions. Most of these companies have substantially greater financial and other resources. This enables them to make greater research and development investments and efficiently utilize their research and development costs, as well as their marketing and promotion costs, over a broader revenue base. OPKO Health’s major competitors include Quest Diagnostics and Laboratory Corporation of America.

Estimate Trend of OPK

OPKO Health is witnessing a negative estimate revision trend for 2025. In the past 60 days, the Zacks Consensus Estimate for its loss has widened from 25 cents to 30 cents per share.

The Zacks Consensus Estimate for the company’s second-quarter 2025 revenues and loss per share is pegged at $165.4 million and 10 cents, respectively. The revenue estimate indicates a 9.2% decline from the year-ago quarter’s reported number.

Stocks to Consider

Some better-ranked stocks in the broader medical space that have announced quarterly results are CVS Health Corporation (CVS - Free Report) , Integer Holdings Corporation (ITGR - Free Report) and AngioDynamics (ANGO - Free Report) .

CVS Health, carrying a Zacks Rank of 2 (Buy), reported first-quarter 2025 adjusted earnings per share (EPS) of $2.25, beating the Zacks Consensus Estimate by 31.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Revenues of $94.59 billion outpaced the consensus mark by 1.8%. CVS Health has a long-term estimated growth rate of 11.4%. Its earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 18.1%.

Integer Holdings reported first-quarter 2025 adjusted EPS of $1.31, beating the Zacks Consensus Estimate by 3.2%. Revenues of $437.4 million surpassed the Zacks Consensus Estimate by 1.3%. It currently sports a Zacks Rank of 1.

Integer Holdings has a long-term estimated growth rate of 18.4%. ITGR’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%.

AngioDynamics, currently sporting a Zacks Rank #1, reported a third-quarter fiscal 2025 adjusted EPS of 3 cents against the Zacks Consensus Estimate of a 13-cent loss. Revenues of $72 million beat the Zacks Consensus Estimate by 2%.

ANGO has an estimated fiscal 2026 earnings growth rate of 27.8% compared with the S&P 500 Composite’s 10.5% growth. AngioDynamics’ earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 70.9%.

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