OPKO Health, Inc. (OPK): Business Model Canvas [Dec-2025 Updated]

You're digging into OPKO Health, Inc. (OPK) now that they've executed a significant pivot, shedding assets to focus hard on pharma pipeline innovation and their core diagnostics business. Honestly, seeing a company balance a lean structure with substantial R&D-which hit $\mathbf{\$30.1}$ million in Q3 2025-is always worth a closer look, especially when they still hold $\mathbf{\$428.9}$ million in cash as of that same quarter. With total 2025 revenue guidance projected between $\mathbf{\$640}$ million and $\mathbf{\$660}$ million, the real test is whether this strategy, anchored by key products like Rayaldee and partnerships like the one with Pfizer for NGENLA, pays off. Below, we map out the entire Business Model Canvas so you can see exactly how they plan to generate revenue from diagnostics ($\mathbf{\$95.2}$ million in Q3 2025) versus product sales ($\mathbf{\$37.7}$ million) moving forward.

OPKO Health, Inc. (OPK) - Canvas Business Model: Key Partnerships

You're looking at the network of external relationships OPKO Health, Inc. relies on to bring its pipeline to market and streamline its operations, especially after significant asset sales. These partnerships are crucial for funding development and accessing global commercial reach, so let's look at the hard numbers involved as of late 2025.

The shift toward co-development and royalty models is evident across several key collaborations. For instance, the deal with Regeneron Pharmaceuticals for multispecific antibodies via ModeX Therapeutics is structured heavily on future success milestones, minimizing OPKO Health's immediate development spend on those assets.

The finalization of the Labcorp transaction provided a significant cash infusion, which OPKO Health, Inc. intends to use, in part, to fund its share repurchase program. This divestiture allows the company to focus capital on its pharmaceutical pipeline.

The NGENLA partnership with Pfizer, while showing royalty revenue that underperformed expectations in the first half of 2025, still represents a baseline revenue stream that management expects to grow substantially in the latter half of the year.

Here's a breakdown of the financial and operational structures of these key alliances:

The collaboration with Entera Bio on the oral GLP-1/glucagon candidate, OPK-88006, establishes a clear cost-sharing mechanism tied to ownership interest. Should Entera Bio opt out after Phase 1, the economics shift significantly to OPKO Health, Inc.'s favor.

• Entera Bio retains 15% ownership if it opts out post-Phase 1.
• OPKO Health, Inc. would then hold 85% of the program.
• OPKO Health, Inc. purchased approx. 3.7 million Entera ordinary shares.
• The oral candidate is designed as a once-daily tablet.

The Merck partnership is focused on clinical progress, with financial triggers tied to trial advancement. The Phase 1 trial is evaluating safety and tolerability in a defined cohort.

• Merck advanced Phase 1 trial (NCT06655324).
• Trial evaluates safety in up to 200 healthy adults.
• Commencement of dosing triggered a milestone payment to ModeX.

For the NGENLA partnership, the royalty structure is based on gross profit sharing from sales of both NGENLA and Pfizer's Genotropin®. The revenue stream is expected to improve as the year progresses, partly due to the phasing out of older, more expensive inventory affecting first-half results.

• NGENLA is approved in over 50 countries.
• Q2 2025 royalty payment was $6.1 million.
• 2024 profit-share revenue was $28.3 million.

The sale of the BioReference oncology assets to Labcorp, which closed on September 15, 2025, was structured with an immediate cash component and a performance-based earnout, providing near-term capital while retaining the core diagnostics business in the New York and New Jersey region, which generated approximately $300 million in revenue for 2024.

Finance: draft 13-week cash view by Friday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Key Activities

You're looking at the engine room of OPKO Health, Inc., the core things they absolutely must do well to keep the lights on and the pipeline moving. It's a mix of lab work, drug development, and selling what they already have approved. Honestly, the numbers show a company actively reshaping its focus, especially after the Labcorp sale.

Research and development (R&D) of novel therapeutics (e.g., ModeX, OPK-88006)

This is where the future value is being built, and it costs real money. Total costs and expenses for the Pharmaceuticals segment in the second quarter of 2025 hit $84.4 million, a jump from $77.6 million in the prior-year quarter, largely driven by R&D growth in BARDA collaborations and early-stage programs. ModeX, OPKO Health's immuno-oncology and immunology portfolio, has four potential clinical candidates progressing. The MDX2001 tetraspecific antibody is in its fifth dose level of a Phase 1 trial. Furthermore, OPKO Health entered a research collaboration with Regeneron Pharmaceuticals leveraging ModeX's MSTAR technology platform; the overall value of this partnership could exceed $1 billion if multiple products succeed, with ModeX eligible for milestone payments over $200 million for each program, plus tiered royalties up to low double digits. The OPK-88006 dual agonist development is split, with OPKO Health shouldering 60% of the development costs and holding a 60% ownership interest, while Entera Bio holds the remaining 40%.

Key R&D/Pipeline Metrics:

• MDX2004 expected to enter the clinic later in 2025.
• MDX2003 and MDX2004 expected to begin human trials in late 2025/early 2026.
• BARDA funding commitment totals $110 million, including an increase of $51 million in Q4 2024.

Manufacturing and supply chain management for pharmaceutical products (EirGen Pharma)

EirGen Pharma, OPKO Health's Irish contract pharmaceutical development and manufacturing unit, is a key operational activity. You see this reflected in the segment performance, as EirGen Pharma continued to show revenue and profit growth in the first quarter of 2025. While specific revenue for EirGen Pharma isn't broken out, the overall Pharmaceuticals segment product revenue was $40.7 million in Q2 2025.

Commercialization and marketing of approved drugs like Rayaldee

Commercialization focuses on getting existing products to market, though the results here are mixed. Rayaldee sales were flat year-over-year in Q2 2025 at $7.2 million, but they did tick up to $7.5 million in Q3 2025 compared to $5.8 million in Q3 2024. The overall Pharmaceuticals product revenue for Q3 2025 was $37.7 million, slightly down from $39.1 million in Q3 2024. Also, OPKO Health receives gross profit share payments for NGENLA, which totaled $6.1 million in Q2 2025.

Operating core clinical testing services and the 4Kscore Test franchise

This is the diagnostics side, which is undergoing a major transition due to asset sales. Diagnostics revenue for Q2 2025 was $101.1 million, down from $129.4 million in Q2 2024, primarily due to lower clinical test volume following asset sales. However, the 4Kscore Test franchise, which represented approximately $300 million in revenue for 2024, is showing positive momentum. Tests were up around 12% on the quarter (Q3 2025), and management noted growth was accelerating in July. The FDA approved a supplemental application for the 4Kscore Test, allowing its use without digital rectal examination information, which should help adoption among primary care providers.

Managing strategic licensing and co-development agreements

Managing these partnerships is critical, as they bring in non-product revenue and share development risk. Revenue from the transfer of intellectual property and other sources was $15.0 million in Q2 2025, up from $12.3 million in Q2 2024, driven by higher revenue from the BARDA contract and contract manufacturers' commercial milestones. The BARDA contract specifically contributed $7.0 million in Q1 2025 revenue. The company also completed the sale of BioReference Health oncology assets to Labcorp for $225 million, including $192.5 million paid at closing.

Here's a quick look at the segment revenue performance for the most recently reported periods:

OPKO Health, Inc. (OPK) - Canvas Business Model: Key Resources

You're looking at the core assets OPKO Health, Inc. (OPK) relies on to execute its strategy as of late 2025. These aren't just line items; they're the engines driving the business.

Proprietary drug delivery and technology platforms represent significant future value. The ModeX Therapeutics subsidiary leverages its MSTAR (ModeX Synergistic Targeting of Antibody Receptors) platform to create multispecific antibodies. A recent collaboration with Regeneron Pharmaceuticals using this platform has a potential total value exceeding $1 billion if multiple products advance, starting with an upfront payment of $7 million and milestone payments potentially over $200 million per selected molecule. Also, ModeX secured a $35 million BARDA supplement and a $16 million option for development work based on the MSTAR technology. Furthermore, the development of OPK-88006, a GLP-1/glucagon peptide for obesity and MASH, utilizes Entera Bio's proprietary N-Tab™ technology for oral delivery.

The value of approved products and intellectual property (IP) is tangible, though subject to market dynamics. Rayaldee, for secondary hyperparathyroidism, generated product revenue of $7.5 million in the third quarter of 2025, an increase from $5.8 million in the prior-year period. The 4Kscore Test, used for prostate cancer risk assessment, was a major asset, having represented approximately $300 million in revenue for 2024. The FDA approval in Q2 2025 for the 4Kscore® Test to be performed without digital rectal examination (DRE) information is a key IP enhancement expected to drive future volume.

Financially, the company maintains a strong liquidity position. As of September 30, 2025, OPKO Health, Inc. (OPK) reported cash, cash equivalents, and restricted cash of $428.9 million. This robust balance followed the September 2025 closing of the sale of certain BioReference oncology assets to Labcorp, which brought in $173.3 million in cash consideration at closing plus an escrow of $19.2 million.

The CLIA-certified laboratory infrastructure, primarily through the remaining BioReference operations, is a core operational asset. For the third quarter of 2025, revenue from services within the Diagnostics segment was $95.2 million. Prior to the asset sale, the BioReference headcount stood at approximately 1,900, with an expected reduction to 1,450-1,500 by Q4 2025 as the business streamlines.

The global network of pharmaceutical manufacturing and distribution facilities supports the Pharmaceuticals segment. Total revenue from products in Q3 2025 was $37.7 million, reflecting both domestic and international operations. Further IP monetization is evident in the transfer of intellectual property and other revenue, which totaled $18.8 million in Q3 2025.

Here's a quick look at the key financial and operational metrics supporting these resources:

You can see the tangible and intangible assets broken down:

• Proprietary Technology Value Drivers:
• MSTAR platform in collaboration with Regeneron.
• N-Tab™ technology for oral peptide delivery.
• Key Product Performance (Q3 2025):
• Rayaldee sales: $7.5 million.
• Pharmaceutical product sales: $37.7 million.
• Laboratory Infrastructure Scale:
• Q3 2025 Services Revenue: $95.2 million.
• BioReference headcount (pre-streamlining): Approx. 1,900.

Finance: draft 13-week cash view by Friday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Value Propositions

The value propositions for OPKO Health, Inc. (OPK) as of late 2025 center on specialized diagnostics and a focused, high-potential pharmaceutical pipeline, often structured through partnerships to mitigate risk.

Next-generation, long-acting human growth hormone therapy (NGENLA)

This value is delivered through a royalty arrangement with Pfizer Inc. (PFE), which handles ownership and distribution. The financial return is realized via gross profit sharing, which has shown variability:

• OPKO Health estimated annual gross profit share revenue for NGENLA between $28 million and $35 million for the full year 2025.
• Gross profit share payments totaled $6.1 million in the second quarter of 2025, down from $6.3 million in the second quarter of 2024.
• Gross profit share payments increased to $8.8 million in the third quarter of 2025, up from $7 million in the third quarter of 2024.
• The company earned $10.6 million from NGENLA profit share in the first six months of 2025.
• Analyst guidance for 2026 suggested a year-over-year flat expectation of $32-35 million.

Improved risk assessment for aggressive prostate cancer (4Kscore Test)

The value here is enhanced diagnostic accuracy, supported by regulatory milestones and market relevance:

• The U.S. Food and Drug Administration (FDA) approved a supplemental application in the second quarter of 2025, allowing the 4Kscore® Test to be performed without digital rectal examination (DRE) information.
• Clinical studies concluded the test is reliable with greater than 96% sensitivity and accuracy (n=937).
• The 4Kscore® Test franchise was part of the core clinical testing services that represented approximately $300 million in revenue for 2024.

Treatment for Secondary Hyperparathyroidism (SHPT) in chronic kidney disease patients (Rayaldee)

Rayaldee provides a treatment option for SHPT patients, with product sales showing modest movement in 2025:

The third quarter of 2025 sales of $7.5 million represented a 29.3% increase from the prior-year period.

Streamlined, focused core clinical testing services in the New York/New Jersey region

Following the sale of oncology assets to Labcorp, the remaining diagnostics business is focused on core services, including the New York/New Jersey region operations:

• The core clinical testing services in the New York and New Jersey region represented approximately $300 million in revenue for 2024.
• Management provided an outlook that the remaining annual revenue from this focused business is approximately $300 million.
• Full-year 2025 guidance for total Revenue from Services was set between $400 million and $500 million, which includes $95 million to $105 million from the assets being sold.
• Third quarter 2025 Diagnostics revenue from services was $95.2 million.

Potential for novel oral treatments for obesity and metabolic disorders (OPK-88006 pipeline)

This represents a high-potential value stream via a partnership to develop a first-in-class oral therapy:

• OPK-88006 is a dual agonist of the GLP-1 and glucagon receptors, intended as a once-daily tablet.
• OPKO Health and Entera Bio expect to file an Investigational New Drug (IND) application later in 2025.
• OPKO Health will hold a 60% ownership interest and be responsible for 60% of the development costs in the collaboration.
• OPKO purchased approximately 3.7 million ordinary shares of Entera at $2.17 per share.

OPKO Health, Inc. (OPK) - Canvas Business Model: Customer Relationships

You're looking at how OPKO Health, Inc. manages its connections with the various groups it serves-from the doctors prescribing its drugs to the patients using its lab services. It's a mix of direct sales, high-level partnerships, and digital self-service.

Dedicated personal selling via field-based nephrology sales representatives for Rayaldee

For Rayaldee, the relationship is definitely hands-on, relying on field-based nephrology sales reps to drive adoption with specialists. This direct engagement is key for a specialty pharmaceutical product. We see the results of this effort reflected in the quarterly sales figures for the drug. For instance, Rayaldee sales hit $7.5 million in the third quarter of 2025, which was an increase from the $5.8 million seen in the third quarter of 2024. However, the first quarter of 2025 saw Rayaldee sales at $6.3 million, a slight dip from the $6.9 million in the first quarter of 2024, and Q2 2025 sales were flat year-over-year at $7.2 million. This fluctuation shows the ongoing effort required in this relationship channel.

Co-development and licensing management with large pharmaceutical partners

Managing relationships with big pharma partners is crucial, especially for monetizing the pipeline through licensing. Take NGENLA, for example, which is on a royalty arrangement with Pfizer Inc. Management estimated full-year 2025 royalty revenue from this to be between $28 million and $35 million, a potential step up from the prior year's profit-share revenue of $28.3 million. The second quarter of 2025 saw royalty payments of $6.1 million. Then there's the ModeX collaboration with Regeneron Pharmaceuticals. This relationship is structured for massive upside, with OPKO Health, Inc. entitled to an upfront payment and potential milestone payments exceeding $200 million for each program, pushing the overall collaboration value potentially past $1 billion if multiple products succeed. Regeneron handles all the development and commercialization costs, which is a very strong customer/partner dynamic for OPKO Health, Inc.

Self-service digital Patient Portal for lab results and billing (BioReference)

For the diagnostics side, which is now more focused after the Labcorp asset sale, the relationship is heavily digitized through the BioReference Patient Portal. This is a self-service channel where patients can access their most recent laboratory reports, review past results, pay their bill, and update insurance information all online. Following the sale of the oncology and related clinical testing assets, the remaining BioReference core clinical testing services, including the 4Kscore Test franchise, continue to rely on this portal for patient interaction. While specific user numbers aren't public, the portal's existence supports a high-volume service model.

Shared decision-making support tools for physicians and patients (4Kscore Test)

The 4Kscore Test is a prime example of a tool designed to foster shared decision-making. This blood test, which combines four biomarkers with clinical factors, provides a numerical value to assess the risk of aggressive prostate cancer before a biopsy. The 4Kscore Test franchise itself represented approximately $300 million in revenue for BioReference in 2024. Historically, the test has been utilized by over 7,700 health care providers, including about 4,200 urologists, as of a 2021 report. OPKO Health, Inc. confirmed that BioReference will continue to offer this comprehensive Urology diagnostic service nationwide, meaning this decision-support relationship remains a core offering.

Customer Service teams available 24/7 for healthcare provider inquiries

For healthcare providers needing support with BioReference services, there are dedicated contact channels. While the outline specifies 24/7 availability, the publicly available contact information lists specific phone numbers for billing inquiries (e.g., 833-469-5227) and patient portal support (e.g., 1-888-279-0967, M-F 9AM-5PM ET for login issues), alongside general corporate contact numbers. The existence of these dedicated lines shows a commitment to addressing provider needs, which is vital for maintaining lab service relationships.

Here's a quick look at some of the key financial and statistical touchpoints related to these customer and partner relationships as of late 2025:

Finance: draft 13-week cash view by Friday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Channels

You're looking at how OPKO Health, Inc. gets its products and services into the hands of patients and providers as of late 2025. It's a mix of relying on big pharma muscle, a focused internal team, and established lab infrastructure.

Global Distribution Network Managed by Partners

For NGENLA, the growth hormone therapy, distribution is handled entirely by the partner, Pfizer. This channel provides global reach, with NGENLA now approved in over 40 markets worldwide. This partnership structure directly translates into royalty/profit share revenue for OPKO Health, Inc. For the third quarter of 2025, the gross profit share payments for NGENLA hit $8.8 million. Looking ahead, the guidance for NGENLA sales in 2026 is set between $32 million and $35 million.

Direct Sales Force Targeting Specialists in the U.S.

For its own pharmaceutical product, Rayaldee, OPKO Health, Inc. relies on a dedicated, specialized sales force within the U.S. targeting nephrologists. While the specific 2025 headcount isn't public, the company previously had plans to expand its field-based nephrology sales representatives to 70. This team supports the commercialization efforts for Rayaldee, which generated $7.5 million in revenue in the third quarter of 2025.

• NGENLA distribution is managed by Pfizer globally.
• Rayaldee commercialization is supported by a specialized U.S. sales team.
• Rayaldee is marketed in the U.S., Germany, Switzerland and Denmark.

BioReference Patient Service Centers and Mobile Phlebotomy Services

The diagnostics arm, primarily through BioReference Laboratories, utilizes a massive physical footprint for sample collection. BioReference Laboratories services approximately 11 million patients annually. Even after the sale of certain oncology assets, the core clinical testing operations in New York and New Jersey, which include some patient service centers (PSCs), represented approximately $300 million in revenue for 2024. The mobile component is supported by a logistics fleet of over 475 cars, driving over 17 million miles annually to support sample collection and delivery.

Specialty Pharmacies and Pharmaceutical Wholesalers for Rayaldee Distribution

Rayaldee, the treatment for secondary hyperparathyroidism, moves through traditional pharmaceutical supply channels. Shipments commence to distributors, making the product available nationwide at retail pharmacies. This channel is critical for reaching the adult patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency who are not on dialysis.

Provider Login Portals for Secure, 24/7 Access to Test Data and EHR Integration

For its diagnostic services, OPKO Health, Inc. provides digital access points for ordering and results retrieval. The company maintains a Provider Login portal, which is the mechanism for healthcare professionals to get secure, 24/7 access to test data. This digital channel is key for integrating results into the provider workflow, especially for tests like the 4Kscore® Test, which is reliable with over 96% sensitivity and accuracy in assessing aggressive prostate cancer probability.

Here's a quick look at the revenue and scale associated with these channels as of late 2025 data:

Finance: review Q4 2025 revenue projections based on NGENLA profit share run rate by next Tuesday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Customer Segments

Global pharmaceutical companies seeking co-development and licensing deals

• ModeX collaboration potential value exceeds $1 billion upon success of multiple products.
• ModeX eligible for tiered royalties on global net sales, up to low double digits at the highest tier.
• Ongoing Phase 1 clinical trial for Epstein-Barr virus vaccine with Merck.
• Collaboration with Entera Bio for oral tablet development.

Patients with pediatric growth hormone deficiency (NGENLA)

Adult patients with Stage 3 or 4 Chronic Kidney Disease and SHPT (Rayaldee)

Urologists and Primary Care Physicians utilizing the 4Kscore Test

• The 4Kscore Test franchise represented approximately $300 million in revenue for 2024.
• Test volume increased year-over-year by approximately 12% in Q2 2025.
• Over 90% of PSA screening tests are performed by primary care providers, potential users.
• FDA approved supplemental application in July 2025 enabling performance without digital rectal examination (DRE) information.

Healthcare providers and patients in the New York/New Jersey region for core clinical testing

The remaining BioReference business is expected to reach profitability this year. Finance: draft 13-week cash view by Friday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Cost Structure

You're looking at the expense side of OPKO Health, Inc.'s operations as of late 2025, which is heavily influenced by its dual focus on pharmaceuticals in development and a streamlined diagnostics business. Here's a breakdown of the major cost drivers based on the third quarter of 2025 results.

The company's operating expenses reflect significant investment in its pipeline alongside cost management in its lab services arm. Research and development (R&D) expenses, totaling $30.1 million in Q3 2025, represent a key outlay for future growth potential. This figure is up 4.5% year over year, driven largely by activities within the ModeX development programs.

Selling, General, and Administrative (SG&A) expenses were reported at $53.8 million for the third quarter of 2025, showing a substantial decline of 45.2% compared to the prior-year quarter, which reflects the impact of strategic realignment and asset sales.

The overall cost structure is detailed in the table below, incorporating the reported revenue and profit figures to derive the cost of revenue components for both segments.

Cost of revenue is a major component, reflecting the operational expenses tied directly to generating the $95.2 million in diagnostic services revenue and $37.7 million in pharmaceutical product revenue for the quarter. The decrease in diagnostics cost of revenue is directly linked to the sale of certain BioReference assets, which saw cost and expenses drop significantly compared to the prior year.

Clinical trial costs are embedded within the R&D spend, specifically supporting pipeline candidates. You see activity across several fronts:

• The Merck and ModeX collaboration on the Epstein-Barr virus vaccine candidate, which entered Phase 1 study in early 2025.
• Advancement of ModeX tetraspecific antibody candidates, with some expected to enter human trials in late 2025 or early 2026.
• Development costs for the oral GLP-1/glucagon tablet candidate with Entera Bio, where OPKO Health is responsible for 60% of development costs.

Restructuring efforts have yielded significant expense reductions, particularly within the Diagnostics business following the Labcorp transaction. While the sale itself generated gains, the underlying cost structure was targeted for efficiency. Management has noted that cost-reduction initiatives were in place, with annualized savings of over $25 million expected from prior restructuring efforts. Furthermore, the company recorded approximately $4.2 million in expected nonrecurring severance costs in Q3 2025 alone.

Finance: draft 13-week cash view by Friday.

OPKO Health, Inc. (OPK) - Canvas Business Model: Revenue Streams

You're looking at how OPKO Health, Inc. (OPK) brings in cash as of late 2025. The revenue picture is clearly segmented across its Diagnostics and Pharmaceuticals divisions, with a notable contribution from non-core activities like IP monetization. This mix shows a company balancing service-based lab revenue with product sales and strategic financial events.

Here is a look at the key revenue components from the third quarter of 2025, which gives you a snapshot of the current operational flow:

The Diagnostics segment, driven by BioReference Health, remains the largest top-line contributor, though it has been streamlined following asset sales. The Pharmaceutical revenue stream is more diverse than just product sales, so you need to watch the non-product elements closely. These are the specific revenue drivers you should be tracking:

• Revenue from services (Diagnostics), which was $95.2 million in Q3 2025.
• Revenue from product sales (Pharmaceuticals), totaling $37.7 million in Q3 2025.
• Revenue from the transfer of intellectual property and other, which was $18.8 million in Q3 2025.
• Gross profit share payments from partners for NGENLA, totaling $8.8 million in Q3 2025.

To be fair, the IP and other category is where you see the impact of deals like the one with Regeneron, plus royalties. Looking ahead, the full-year 2025 total revenue guidance is projected to be between $640 million and $660 million, which suggests the fourth quarter needs to perform solidly to hit that range after the Q3 results. Finance: draft 13-week cash view by Friday.