OPKO Health (NASDAQ:OPK) reported first-quarter financial results on Tuesday. The transcript from the company’s first-quarter earnings call has been provided below.
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Summary
OPKO Health Inc reported first quarter 2026 revenue of $124.2 million, a decrease from $149.9 million in Q1 2025, with a consolidated operating loss of $51 million, improving from a $67.2 million loss in the previous year.
The company is advancing its Modex product development pipeline, including several clinical trials for oncology and immunology treatments, and anticipates multiple clinical and partnership milestones in 2026.
Collaboration with Regeneron and BARDA is progressing, with potential milestones exceeding $1 billion and significant funding for infectious disease programs, respectively.
The diagnostics business is focusing on its core regional operations, with a targeted strategy to achieve breakeven by mid-year and expand its 4Kscore test offering.
OPKO Health Inc maintains a strong cash position of $341 million to support ongoing operations and R&D investments, with plans for future revenue growth driven by its biopharmaceutical and diagnostics segments.
Full Transcript
OPERATOR
Good day and welcome to the OpcoHealth First Quarter 2026 Financial Results Conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchstone phone. To withdraw your question, please press Star then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
Yvonne Briggs (Investor Relations)
Thank you operator and good afternoon, this is Yvonne Briggs with Alliance Advisors IR. Thank you all for joining today’s call to discuss OPKO Health Inc financial results for the first quarter of 2026. I’d like to remind you that any statements made during this call by management, other than statements of historical fact, will be considered forward looking and as such are subject to risks and uncertainties that could materially affect the company’s results. Those forward looking statements include, without limitation, the various risks described in the company’s SEC filings, including the Annual Report on Form 10-K for the year ended December 31, 2025. Furthermore, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast, April 28, 2026. Except as required by law, OPCO undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this call. Regarding the format of today’s call, Dr. Philip Frost, chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Sirhouny, Vice Chairman and President, will then provide an overview of OPKO’s therapeutic segment as well as BioReference Health. After that, Adam Logel, OPKO’s CFO, will review the company’s first quarter financial results and discuss OPKO’s financial outlook. And then we’ll open the call to questions. Now I’d like to turn the call over to Dr.
Philip Frost (Chairman and Chief Executive Officer)
Thank you for joining us today. During the first quarter we made meaningful progress with our strategic initiatives, with particular emphasis on advancing our MODEX product development pipeline. MODEX now has five programs in the clinic spanning vaccines, oncology and immunology, all with the potential to be first and best in class in their therapeutic areas. Days after the close of the first quarter, we dosed our first subjects in the phase 1 clinical trial of MDX2301, our BARDA funded multispecific antibody for the prevention of COVID in high risk populations. Shortly thereafter, we announced the dosing of the first patient in a phase 1 trial to evaluate MDX 2003, a tetra specific T cell engager in patients with relapsed or refractory B cell lymphoma. We also continue to advance our other oncology candidates in Clinical Development, MDx2001, a tetraspecific T cell engager targeting solid tumors, and MDx2004, a multispecific immune rejuvenator. Over the course of this year, we expect MODEX to achieve a number of clinical and partnership milestones as these programs progress and in the case of our EBV vaccine approach, later stage development with our partner Merck. Our collaboration with Regeneron is progressing well as we align their extensive antibody binder libraries with our multispecific engineering platform across various indications in metabolism, oncology and immunology. This collaboration is another example of strategic partnerships that are a good source of non dilutive capital to support our RD efforts. The potential total value of the regenerant collaboration exceeds $1 billion in milestones plus future royalties in our diagnostics business. Q1 reflects our second full quarter with the new BioReference footprint following our oncology divestiture. We’re now centered on our core regional clinical laboratory operations in New York and New Jersey, our correctional health business and our national specialty urology testing franchise anchored by the 4K score test. We continue to streamline our infrastructure and cost base to achieve profitable growth from this segment. We closed the quarter with a solid cash balance. This reflects past asset sales, continued R and D support from our partners, and contributions from our international pharmaceutical operations. This financial strength enables us to fund our RD portfolio at a meaningful level and to return capital to shareholders through our stock repurchase program. With that overview, I’ll turn the call over to Elias.
Elias Sirhouny (Vice Chairman and President)
Well, thank you Phil, and good afternoon everyone. Let me start with the biopharmaceutical side of our business because that’s where we’re making tremendous progress advancing our pipeline right now. As Dr. Frost said, we now have five assets in the clinic and expect an additional program for our in vivo CAR T cell platform to commence first in human clinical trials this year. So let me review our programs and provide updates on each of them. Our collaboration with Merck is focused on a vaccine against Epstein Barr virus that combines four Epstein-Barr Virus (EBV) antigens developed by MODEX with Merck’s adjuvants. In the phase one trial, Merck enrolled over 200 subjects to evaluate safety, tolerability and immunogenicity, and various subgroup studies and analysis are underway to understand the responses in Epstein-Barr Virus (EBV) naive subjects and patients as young as 12 years of age, which will be important for future studies. So we expect Merck to have the data needed to inform a Phase two design by the end of this year, with initiation of a phase 2 clinical study anticipated next year. Subject to Merck’s decisions and announcements now for MDX 2001, which is our lead immuno oncology candidate for solid tumors including head and neck, esophageal, pancreatic, lung and prostate cancers. MDX2001, as you know, is a tetra specific T cell engager directed at two tumor antigens, CMET and TROP 2 and 2T cell activators CD3 and CD28. The goal is to drive a deeper and more durable response by simultaneously recognizing heterogeneous tumor antigen expression and providing both CD3 and CD28 activators and enhancers to T cells, thereby enhancing activation and T cell survival. Enrollment of Phase one studies continuing into two parallel cohorts to support dose escalation and optimize the dosing regimen. We have dosed more than 30 patients so far across multiple tumor types and have reached dose levels approximately tenfold higher than the starting dose, all with acceptable safety. We plan to present phase 1a data at a conference in the second half of this year. In addition, phase 1b is expected to start later this year, focusing on the tumor types most likely to show signs of efficacy. We’re also commencing work to enable subcutaneous formulations for our next program, MDX2004, which is our first in class multi specific immune rejuvenator that simultaneously engages CD3, CD28 and 41 BB to not only activate but also expand and sustain stem like and memory T cells in the immune system. Preclinical data has demonstrated that MDX 2004 expands stem T cells, increases the T cell activation and stimulates proliferation of CD8 and CD4 memory subsets and so these its potential as a pipeline in a product across cancers and chronic infections among the elderly and immune impaired subjects. MDX 2004 entered phase one in the third quarter of late last year and we’re currently in the dose escalation stage in heavily pretreated cancer patients. The trial includes both PD1 naive patients and patients previously treated with PD1 inhibitors with the goal of determining whether immune rejuvenation can restore or prolong responses. Our objective this year is to complete Phase 1A, define an appropriate dose and schedule, and prepare for expansion into select tumor types and longer term into broader immune impairment indications. Now our newest molecule in the clinic is MDX 2003. It’s our T3 specific T cell engager and expander targeting both CD19 and CD20 on B cells and CD3 and CD28 on T cells. The intent is to address tumor antigen heterogeneity and escape mechanisms, which we see with CD19 only or CD20 only approaches by maintaining activity even when 1B cell marker is lost while CD28CO stimulation supports sustained T cell function. We recently initiated a phase one trial in B cell lymphomas and leukemias in Australia and Israel, with additional sites to follow in parallel. We’re evaluating the optimal path to explore autoimmune indications for MDX 2003, which has a potential to play a role in autoimmunity. In March, MODEX presented two posters at the ESMO Targeted Anti Cancer Therapies Congress 2026 in Paris, further highlighting the breadth of our oncology portfolio. One presentation profiled MDX 2004 describing the ongoing first in human trial in patients with advanced tumors and introducing the concept of immune rejuvenation as a differentiated approach to restoring antitumor immunity. The second was focused on MDX 2003 and showcased its potent preclinical activity across multiple B cell malignancy models and its potential relevance in autoimmunity. In addition to our own research, we’re very pleased with the progress under our collaboration with regeneron, which, as Dr. Frost mentioned, combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology and metabolic diseases. Together, the teams are focused on advancing four initial discovery programs using the MODEX platform to rapidly generate and optimize multi specific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical clinical and commercial development of the selected assets, while OPCO is eligible for research development, regulatory and commercial milestones that could exceed $1 billion, as well as tiered royalties on global sales up to the low double digits. Now moving to infectious diseases, MDX2301 is the first MODEX multi specific antibody program to enter the clinic under our collaboration with BARDA. MDX2301 is a tetravalent bispecific antibody that targets distinct and conserved regions of the SARS CoV2 spike receptor binding domain and it is designed for broad coverage and long duration of protection because it really attacks two separate regions of the virus which prevents escape of the virus through mutations. The initial indications are prophylaxis in high risk immunocompromised populations who cannot be protected by immunization vaccination and used in post exposure outbreak settings with potential expansion into acute treatment of COVID and the treatment of long Covid. To date, remarkably, this multispecific antibody has demonstrated high potency against all known variants of SARS COV2V2 and continues to be effective against all circulating variants of the virus. We initiated the Phase 1 trial of MDX 2301 which is evaluating safety and tolerability across different routes of administration and dosing regimens in healthy volunteers and in adults at high risk for severe co occurring and the first dose cohort is completed and BARDA is funding the program including the clinical trial costs. BARDA is also supporting our Multi Specific Influenza program which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains. We’re currently conducting pre IND work using challenge models to select the lead clinical candidate and we expect this program to move closer to the commencement of clinical trials with the potential for additional financial support from BARDA. To date, BARDA has committed over $100 million since the inception of these two programs. Now, over the past several years MODEX has also built a multimodal in vivo CAR T and gene delivery platform that we believe is highly differentiated versus traditional ex vivo CAR T approaches because it combines our unique multi specific technology with proprietary in vivo CAR technologies. Using lipid nanoparticles conjugated with cell specific multi specific antibodies on the surface, we can deliver MRNA or DNA payloads encoding cars directly to specific immune cell subset not only just T cells but also B cells or NK cells to generate functional CAR T cells in vivo at lower effective doses. Preclinical data has been obtained in humanized mice and non human primates and a presentation of this work will be made at the ASGCT meeting in Boston next month and we believe this technology offers several potential advantages. It is off the shelf, can be redosed and leverages our multi specific antibodies for cell specific targeting and built in activation via CD3 CD28. It also uses site specific antibody conjugation and proprietary lipids to support manufacturability at scale and reduce off target delivery to the liver. In non human primate studies we have shown proof of concept for in vivo CAR T generation, deep B cell depletion in blood and tissues and a favorable tolerability profile. These effects were achieved at doses that were a fraction of those reported for completing platforms for competing platforms. Sorry, we’re now in IND enabling studies for our lead CD19 targeted in vivo CAR T program and expect entry into the clinic by the end of this year or early 2027. Now turning to our endocrine and metabolic programs, we continue to advance our subcutaneous injection formulation of UBCO. ADA 006 for the treatment of MASH 88006 is an analog of the natural GLP1 glucagon hormone occipital modulin and we’re planning a first in human single ascending dose and multiple ascending dose phase 12 a clinical study with data expected by the second half of 2027. The findings will be used to guide the further development of our oral oxyntomodulin in partnership with Entera Bio. We also recently expanded our relationship with Entera to include a third joint program for a first in class long acting PTH tablets for patients with hypoparathyroidism and this program combines opsco’s proprietary long acting PTH variants, Bonanteros and Tab technology and we in NTERA each hold a 50% ownership interest in this program and we will share development costs equally. Presuming favorable PK PD data, we’re targeting an IND filing later this year. Now our international pharmaceutical operations continue to experience solid growth during Q1 with healthy contributions to the overall business. For the quarter, global pharmaceutical product sales grew about 9% versus the prior year due to favorable demand trends as well as foreign currency tailwinds. Our partner Pfizer continues its global commercial expansion of our long acting growth hormone product enGENE. …
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