Q2 2026 OPKO Health Inc Earnings Call

July 27, 2026

Speaker #1: Good day, and welcome to the OPKO Health second quarter 2026 business highlights and financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: Good day. Welcome to the OPKO Health Second Quarter 2026 Business Highlights and Financial Results Conference Call. All participants will be in a 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 touchtone 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 Ms. Vivian Cervantes of investor relations. Please go ahead, ma'am.

Operator: Good day, and welcome to the OPKO Health Q2 2026 Business Highlights and Financial Results Conference Call. All participants will be in a 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 touch-tone 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 Ms. Vivian Cervantes of investor relations. Please go ahead, ma'am.

Speaker #1: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your touch-tone phone.

Speaker #1: And to withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Ms. Vivian Cervantes of Investor Relations.

Speaker #1: Please go ahead, ma'am.

Speaker #2: Thank you, Esque. Thank you, operator. Good afternoon, everyone. This is Vivian Cervantes with Alliance Advisors IR. Thank you all for joining us on today's call to discuss OPKO Health financial results for the second quarter 2026.

Vivian Cervantes: Thank you. Thank you, operator. Good afternoon, everyone. This is Vivian Cervantes with Alliance Advisors IR. Thank you all for joining us on today's call to discuss OPKO Health's financial results for the Q2 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 31 December 2025. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, 27 July 2026.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, July 27, 2026. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call.

Vivian Cervantes: Except as required by law, OPKO 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. Phillip Frost, Chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of OPKO's therapeutic segment, as well as BioReference Health. After that, Adam Logal, OPKO's CFO, will review the company's Q2 financial results and discuss OPKO's financial outlook. Then we will open the call to questions. I'd like to turn the call over to Dr. Frost.

Speaker #2: Regarding the format of today's call, Dr. Phillip Frost, Chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of OPKO's therapeutic segment, as well as BioReference Health.

Speaker #2: After that, Adam Logal, OPKO's CFO, will review the company's second quarter financial results and discuss OPKO's financial outlook. Then, we will open the call to questions.

Speaker #2: Now, I'd like to turn the call over to Dr. Frost.

Speaker #3: Good afternoon, and thank you for joining us today. During the second quarter, we made meaningful progress in improving operating efficiency and profitability, and in advancing our product pipeline.

Phillip Frost: Good afternoon, thank you for joining us today. During the Q2, we made meaningful progress in improving operating efficiency and profitability, and in advancing our product pipeline. Modex continues to move forward with its present portfolio of five clinical trial programs in oncology, immunology, and vaccines, each with the potential to deliver first and best-in-class medicines. We initiated a phase I/IIa clinical safety and efficacy study in the US of our GLP-1 glucagon candidate, we plan to enroll 44 healthy volunteers and presumed MASH patients to assess single-dose tolerability and pharmacokinetics. OPKO Biologics is making progress with its human growth hormone antagonist to treat acromegaly, its GLP-2 program for patients with short bowel syndrome, and its oral PTH to treat hypoparathyroidism. NGENLA, our growth hormone product, partnered with Pfizer, continues to increase market penetration as we advance label expansion clinical trials.

Phillip Frost: Good afternoon, thank you for joining us today. During the Q2, we made meaningful progress in improving operating efficiency and profitability, and in advancing our product pipeline. Modex continues to move forward with its present portfolio of five clinical trial programs in oncology, immunology, and vaccines, each with the potential to deliver first and best-in-class medicines. We initiated a phase I/II-A clinical safety and efficacy study in the US of our GLP-1 glucagon candidate, we plan to enroll 44 healthy volunteers and presumed MASH patients to assess single-dose tolerability and pharmacokinetics. OPKO Biologics is making progress with its human growth hormone antagonist to treat acromegaly, its GLP-2 program for patients with short bowel syndrome, and its oral PTH to treat hypoparathyroidism. NGENLA, our growth hormone product, partnered with Pfizer, continues to increase market penetration as we advance label expansion clinical trials.

Speaker #3: Modex continues to move forward with its present portfolio of five clinical trial programs in oncology, immunology, and vaccines, each with the potential to deliver first- and best-in-class medicines.

Speaker #3: We initiated a Phase 1/2a clinical safety and efficacy study in the U.S. of our GLP-1/glucagon candidate, and we plan to enroll 44 healthy volunteers and presumed MASH patients to assess single-dose tolerability and pharmacokinetics.

Speaker #3: OPKO Biologics is making progress with its human growth hormone antagonist to treat acromegaly, its GLP-2 program for patients with short bowel syndrome, and its oral PTH to treat hypoparathyroidism.

Speaker #3: And JANGLA, our growth hormone product partnered with Pfizer, continues to increase market penetration as we advance label expansion clinical trials. I'm pleased that we ended the second quarter with a strong cash position and a solid balance sheet that continues to fund our R&D portfolio at a meaningful level.

Phillip Frost: I'm pleased that we ended the Q2 with a strong cash position and a solid balance sheet that continues to fund our R&D portfolio at a meaningful level, while also returning capital to shareholders through our ongoing stock repurchase program. With that brief overview, I'll turn the call over to Elias. Elias?

Speaker #3: While also returning capital to shareholders through our ongoing stock repurchase program. With that brief overview, I'll turn the call over to Elias. Elias?

Speaker #4: Sorry, I was on mute, and thank you, everyone, for joining us today. And thank you, Phil. Let me take this opportunity to highlight continued advancements in our pipeline targeting important unmet clinical needs across large markets.

Elias Zerhouni: Sorry, I was on mute. Thank you everyone for joining us today, and thank you, Phil. Let me take this opportunity to highlight continued advancements in our pipeline, targeting important unmet clinical needs across large markets. First, in immuno-oncology and immunology, I'll start with Modex, where we now have five assets in the clinic and expect a sixth program, our in vivo CAR T asset, to begin first in human clinical trials by the end of this year or in early 2027. Our collaboration with Merck for MDX-2201 focused on a vaccine against Epstein-Barr virus, commonly known as the cause of infectious mononucleosis, but is also associated with several cancers and immune-related conditions such as multiple sclerosis, continues to advance. The program, fully funded by Merck, is in the late stages of data analysis of its completed phase I trial.

Speaker #4: First, at DBNO Oncology and Immunology, I'll start with Modex, where we now have five assets in the clinic and expect a sixth program—our in vivo CAR-T asset—to begin first-in-human clinical trials by the end of this year or in early 2027.

Speaker #4: Our collaboration with Merck for MDX2201, focused on the vaccine against Epstein-Barr virus—commonly known as the cause of infectious mononucleosis but also associated with several cancers and immune-related conditions such as multiple sclerosis—continues to advance.

Speaker #4: The program, fully funded by Merck, is in the late stages of data analysis of its completed Phase 1 trial. We continue to expect Merck to have the data to inform the Phase 2 design by the end of this year, with a potential progression to a Phase 2 clinical study next year.

Elias Zerhouni: We continue to expect Merck to have the data to inform the phase II design by the end of this year, with a potential progression to phase II clinical study next year. MDX2001, our lead immuno-oncology candidate for solid tumors, including head and neck, esophageal, pancreatic, lung, and prostate cancers, continues to advance in phase I and is expected to conclude dose escalation and regimen optimization by Q3 or early Q4 2026. We expect early data to be presented at a medical conference in late 2026 or early 2027, we are underway with initiatives to enable subcutaneous formulations. A differentiated tetraspecific design, MDX2001 combines dual tumor antigen targeting, Trop-2 and c-Met, with dual T-cell activation, CD3/CD28, to enhance immune engagement and potentially deliver deeper, more durable responses than conventional T-cell engagers.

Speaker #4: MDX2001, our lead immuno-oncology candidate for solid tumors—including head and neck, esophageal, pancreatic, lung, and prostate cancers—continues to advance in phase 1 and is expected to conclude dose escalation and regimen optimization by Q3 or early Q4 2026, with early data expected to be presented at a medical conference in late 2026 or early 2027. We're also underway with initiatives to enable subcutaneous formulations.

Speaker #4: A differentiated, tetra-specific design—MDX2001—combines dual tumor antigen targeting (TROP2 and c-MET) with dual T-cell activation (CD3, CD28) to enhance immune engagement and potentially deliver deeper, more durable responses than conventional T-cell engagers.

Speaker #4: Now, MDX2003, our next-generation tetra-specific, directed to CD19, CD20, and tumor cells, and CD3, CD28 on T-cells, is an engager expander designed to harness and amplify the body's immune system by precisely connecting T-cells to B-cell cancers.

Elias Zerhouni: Now, MDX2003, our next generation tetraspecific, directed to CD19/CD20 on tumor cells and CD3/CD28 on T-cell, is an engager expander designed to harness and amplify the body's immune system by precisely connecting T-cells to B-cell cancers, driving enhanced T-cell activation and expansion to enable sustained anti-tumor responses. MDX2003 has entered its phase I clinical trial, is enrolling patients. In parallel, we are also evaluating the optimal path to explore autoimmune indications for MDX2003. Now, MDX2004, our first-in-class trispecific, which is a CD3, CD28, and 4-1BB ligand immune modulator antibody fusion molecule engineered to rejuvenate exhausted T-cells and other immune cells, primarily in heavily pretreated cancer patients, is enrolling patients in phase I. We expect to announce preliminary data in 2027.

Speaker #4: Driving enhanced T-cell activation and expansion to enable sustained anti-tumor responses, MDX2003 has entered its Phase 1 clinical trial and is enrolling patients. In parallel, we are also evaluating the optimal path to explore autoimmune indications for MDX2003.

Speaker #4: Now, MDX2004, our first-in-class tri-specific—which is a CD3, CD28, and 4-1BB ligand immune modulator antibody fusion molecule engineered to rejuvenate exhausted T-cells and other immune cells, primarily in heavily pretreated cancer patients—is enrolling patients in Phase 1.

Speaker #4: We expect to announce preliminary data in 2027. And finally, MDX2301, our fifth Modex program in the clinic, fully funded by BARDA, is a multi-specific COVID-19 antibody that has been shown to be active against all prior and current circulating variants of the virus. It is aimed at the prevention of COVID-19, primarily in high-risk immunocompromised patients.

Elias Zerhouni: Finally, MDX2301, our fifth ModeX program in the clinic, fully funded by BARDA, is a multispecific COVID-19 antibody that has been shown to be active against all prior and current circulating variants of the virus, aimed at the prevention of COVID-19, primarily in high-risk immunocompromised patients. We are completing enrollment of its phase I clinical trials in this Q3 of this year, with early results to be presented at medical meetings later this year or early 2027, which will inform next development stages. In addition to COVID multi-specific antibodies, 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 are currently conducting pre-IND work for this program. We are also excited by our continuing progress toward advancing our sixth ModeX asset, MDX3001, into clinical trials following the successful completion of all preclinical studies.

Speaker #4: We're completing enrollment of its phase 1 clinical trials in the third quarter of this year, with early results to be presented at medical meetings later this year or early 2027, which will inform next development stages.

Speaker #4: In addition to COVID, 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.

Speaker #4: And we're currently conducting pre-I&D work for this program. We're also excited by our continued progress toward advancing our sixth Modex asset, MDX2001, into clinical trials following the successful completion of all preclinical studies.

Speaker #4: Unlike traditional CAR-T therapy, we believe our in vivo CAR-T program is highly differentiated, as it leverages our multi-specific antibody expertise and platform with targeted lipid nanoparticles, seeking to generate engineered T-cells directly inside the patient's body by delivering the CAR payload to the right immune cells in the body—a selection made possible by our multi-specific technology.

Elias Zerhouni: Unlike traditional CAR T therapy, we believe our in vivo CAR T program is highly differentiated as it leverages our multi-specific antibody expertise and platform with targeted lipid nanoparticles, seeking to generate engineered T-cells directly inside the patient body by delivering the CAR payload to the right immune cells in the body, which we can select due to our multi-specific technology. We are now in IND-enabling studies and expect to begin clinical studies by the end of 2026 or early 2027, potentially in cancer and autoimmunity indications. In May, MDX3001 data was presented at the American Society of Gene & Cell Therapy, demonstrating in vivo CAR T-cell generation with B-cell depletion in blood lymphoid tissues, including spleen, bone marrow, and lymph nodes. Activity was confirmed in both humanized mouse and non-human primate models.

Speaker #4: We are now in I&D enabling studies, and expect to begin clinical studies by the end of 2026 or early 2027, potentially in cancer and autoimmune indications.

Speaker #4: In May, MDX2001 data was presented at the American Society of Gene and Cell Therapy, demonstrating in vivo CAR-T cell generation with B-cell depletion in blood and lymphoid tissues, including spleen, bone marrow, and lymph nodes.

Speaker #4: Activity was confirmed in both humanized mouse and non-human primate models. Now, turning to research conducted with our partners, we're pleased to note continued progress with our collaboration with Regeneron, which combines their extensive library of clinically validated monoclonal antibody binders with our modular, multi-specific architecture across immunology, oncology, and metabolic diseases.

Elias Zerhouni: Turning to research conducted with our partners, we're pleased to note continued progress with our collaboration with Regeneron, which combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology, and metabolic diseases. We remain focused on advancing four initial discovery programs with Regeneron using the ModeX platforms to rapidly generate and optimize multispecific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical, clinical, and commercial development of selected assets, while OPKO 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. We have also advanced the development of the once-weekly dual GLP-1 glucagon agonist, OPK-88006. The phase I/IIa randomized double-blind placebo-controlled clinical trial is open to enrolling participants in the US.

Elias Zerhouni: Turning to research conducted with our partners, we're pleased to note continued progress with our collaboration with Regeneron, which combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology, and metabolic diseases. We remain focused on advancing four initial discovery programs with Regeneron using the ModeX platforms to rapidly generate and optimize multispecific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical, clinical, and commercial development of selected assets, while OPKO 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. We have also advanced the development of the once-weekly dual GLP-1 glucagon agonist, OPK-88006. The phase I/II-A randomized double-blind placebo-controlled clinical trial is open to enrolling participants in the US.

Speaker #4: We remain focused on advancing four initial discovery programs with Regeneron, using the Modex platforms 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 selected assets, while OPKO 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.

Speaker #4: We have also advanced the development of the once-weekly dual GLP-1/glucagon agonist, OPKO ADA006. The Phase 1/2a randomized, double-blind, placebo-controlled clinical trial is open to enrolling participants in the U.S.

Speaker #4: The first part of the trial is to evaluate the pharmacokinetics and tolerability of OPKO ADA006 at three levels of ascending doses in healthy volunteers.

Elias Zerhouni: The first part of the trial is to evaluate the pharmacokinetic and tolerability of OPK-88006 at 3 levels of ascending doses in healthy volunteers. The phase IIa portion of the trial will evaluate the safety and effectiveness of OPK-88006 administered once weekly for 16 weeks in participants with presumed MASH or Metabolic Dysfunction Associated Steatohepatitis. We're also steadily advancing programs in OPKO Biologics. Our parathyroid hormone program, in collaboration with Entera Bio, as a first-in-class oral long-acting PTH tablet for hypoparathyroidism, which is structured under a 50/50 economic arrangement, reported excellent preclinical results at the recent Endocrine Society, or ENDO, conference. The data showed that the tablet was well-tolerated, no safety concern identified, and calcemic effects were consistent with those reported for clinically validated injectable PTH replacement therapies for hypoparathyroidism. Ongoing studies are advancing this program towards first-in-human clinical evaluation with an intention to file an IND later this year.

Elias Zerhouni: The first part of the trial is to evaluate the pharmacokinetic and tolerability of OPK-88006 at 3 levels of ascending doses in healthy volunteers. The phase II-A portion of the trial will evaluate the safety and effectiveness of OPK-88006 administered once weekly for 16 weeks in participants with presumed MASH or Metabolic Dysfunction Associated Steatohepatitis. We're also steadily advancing programs in OPKO Biologics. Our parathyroid hormone program, in collaboration with Entera Bio, as a first-in-class oral long-acting PTH tablet for hypoparathyroidism, which is structured under a 50/50 economic arrangement, reported excellent preclinical results at the recent Endocrine Society, or ENDO, conference. The data showed that the tablet was well-tolerated, no safety concern identified, and calcemic effects were consistent with those reported for clinically validated injectable PTH replacement therapies for hypoparathyroidism. Ongoing studies are advancing this program towards first-in-human clinical evaluation with an intention to file an IND later this year.

Speaker #4: The phase 2a portion of the trial will evaluate the safety and effectiveness of OPKO ADA006 administered once weekly for 16 weeks in participants with presumed MASH, or metabolic dysfunction-associated steatohepatitis.

Speaker #4: We're also steadily advancing programs in OPKO Biologics. Our prior thyroid hormone program, in collaboration with Entera Bio, is a first-in-class oral, long-acting PTH tablet for hypothyroidism, which is structured under a 50/50 economic arrangement. It reported excellent preclinical results at the recent Endocrine Society, or ENDO, conference.

Speaker #4: The data showed that the tablet was well tolerated, no safety concerns were identified, and calcemic effects were consistent with those reported for clinically validated injectable PTH replacement therapies for hypothyroidism.

Speaker #4: Ongoing studies are advancing this program towards first-in-human clinical evaluation, with an intention to file an IND later this year. Our long-acting human growth hormone antagonist program, known as OPKO ADA01001, which is designed to treat patients with acromegaly, is expected to advance to clinical trials at the end of 2026, based on the results presented at ENDO last month.

Elias Zerhouni: Our long-acting human growth hormone antagonist program, or known as OPK-8801001, which is designed to treat patients with acromegaly, is expected to advance to clinical trials at the end of 2026, based on the results presented at ENDO last month. With OPK-8801001, we envision a once-weekly injection that could significantly improve upon the current standard of care, which requires daily injections. NGENLA, our long-acting human growth hormone commercialized by our partner Pfizer, continues to progress commercially according to plan. In addition, clinical label expansion through ongoing studies are underway, building on pediatric growth hormone deficiency label to further expand both market access and geographic reach. Currently approved and commercialized in over 50 markets, the NGENLA long-acting pediatric growth hormone deficiency product is contributing meaningfully to recurrent cash flow.

Speaker #4: With OPKO ADA01001, we envision a once-weekly injection that could significantly improve upon the current standard of care, which requires daily injections. ENGENDA, our long-acting human growth hormone commercialized by our partner Pfizer, continues to progress commercially according to plan.

Speaker #4: In addition, clinical label expansions through ongoing studies are underway, building on the pediatric growth hormone deficiency label to further expand both market access and geographic reach.

Speaker #4: Currently approved and commercialized in over 50 markets, the Engendra long-acting pediatric growth hormone deficiency product is contributing meaningfully to recurrent cash flow. Turning to our international pharmaceutical businesses, our Ibero-America business continues to grow with sustainable profitability, as we focus on accelerating top-line growth and driving further operating efficiencies.

Elias Zerhouni: Turning to our international pharmaceutical businesses, our Iberoamerica business continues to grow with sustainable profitability as we focus on accelerating top-line growth and driving further operating efficiencies. Further, RAYALDEE, our innovative vitamin D commercialized product, continues to perform to plan and is contributing nicely to our operating cash flows. For the quarter, global pharmaceutical product sales grew about 7% year to date as of 30 June of this year due to favorable demand trends and as well as foreign currency tailwinds. I'd like to turn finally to our clinical diagnostics business. As previously announced, following the sale of select oncology and oncology-related clinical testing assets to LabCorp in 2025, we received $192.5 million payment at closing, along with an additional $18.4 million earn-out payment received in the Q2 of 2026.

Elias Zerhouni: Turning to our international pharmaceutical businesses, our Iberoamerica business continues to grow with sustainable profitability as we focus on accelerating top-line growth and driving further operating efficiencies. Further, RAYALDEE, our innovative vitamin D commercialized product, continues to perform to plan and is contributing nicely to our operating cash flows. For the quarter, global pharmaceutical product sales grew about 7% year-to-date as of 30 June of this year due to favorable demand trends and as well as foreign currency tailwinds. I'd like to turn finally to our clinical diagnostics business. As previously announced, following the sale of select oncology and oncology-related clinical testing assets to LabCorp in 2025, we received $192.5 million payment at closing, along with an additional $18.4 million earn-out payment received in the Q2 of 2026.

Speaker #4: Further, Rialti, our innovative vitamin D commercialized product, continues to perform to plan and is contributing nicely to our operating cash flows. For the quarter, global pharmaceutical product sales grew about 7% year-to-date as of June 30.

Speaker #4: of this year, due to favorable demand trends, as well as foreign currency tailwinds. Now, I'd like to turn finally to our clinical diagnostics business. As previously announced, following the sale of select oncology and oncology-related clinical testing assets to Labcorp in 2025...

Speaker #4: We received a $192.5 million payment at closing, along with an additional $18.4 million earn-out payment received in the second quarter of 2026. We continue to strengthen BioReference's core diagnostics platform by leveraging our regional clinical lab operations and national specialty testing franchise, with our proprietary 4Kscore test serving as a key driver of growth.

Elias Zerhouni: We continue to strengthen BioReference's core diagnostics platform by leveraging our regional clinical lab operations and national specialty testing franchise with a proprietary 4Kscore test, serving as a key driver of growth. We continue to see 4Kscore test as a unique high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating urologists and primary care physicians about its clinical utility. Therefore, as we operate with a more efficient footprint and an expanding menu of higher-margin services, we're progressing towards achieving breakeven and positioning the business for sustainable profitability. In summary, we're encouraged by steady advancements in our ModeX portfolio, which is fully engaged in clinical development, in our biologics portfolio and partner programs, while generating non-dilutive revenue and more profitable growth and cash flow from our global pharmaceutical business and BioReference Lab.

Speaker #4: We continue to see 4Kscore tests as a unique high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating urologists and primary care physicians about its clinical utility.

Speaker #4: Therefore, as we operate with a more efficient footprint and an expanding menu of higher-margin services, we're progressing towards achieving break-even and positioning the business for sustainable profitability.

Speaker #4: In summary, we're encouraged by the steady advancements in our ModeX portfolio, which is fully engaged in clinical development; in our biologics portfolio and partner programs, while generating non-dilutive revenue and more profitable growth and cash flow from our global pharmaceutical business and BioReference Health.

Speaker #4: With that, I'll turn the call over to Adam to review our financial results and outlook. Adam?

Elias Zerhouni: With that, I'll turn the call over to Adam to review our financial results and outlook. Adam?

Speaker #2: Thank you, Elias. We entered the end of the quarter in a strong position, with over $300 million in cash, cash equivalents, and restricted cash.

Adam Logal: Thank you, Elias. We ended the quarter with a strong cash position with over $300 million in cash equivalents, and restricted cash, which is more than sufficient to fund our ongoing operations and development plans while continuing to return capital to our shareholders through our share buyback program. During the quarter, we repurchased 9.7 million shares for approximately $13 million. We have approximately $94 million authorized to repurchase additional shares of our common stock. Let's move to the financial performance of our diagnostics business. Revenue for Q2 2026 was $74.5 million, including $6.2 million from our 4Kscore test. Revenue in Q2 2025 was $101.1 million, with the year-over-year decline expected due to the sale of our oncology customer accounts to LabCorp.

Speaker #2: This is more than sufficient to fund our ongoing operations and development plans, while continuing to return capital to our shareholders through our share buyback program.

Speaker #2: During the quarter, we repurchased 9.7 million shares for approximately $13 million. We have approximately $94 million authorized to repurchase additional shares of our common stock.

Speaker #2: Let's move to the financial performance of our Diagnostics business. Revenue for Q2 2026 was $74.5 million, including $6.2 million from our 4Kscore test.

Speaker #2: Revenue in Q2 2025 was $101.1 million, with the year-over-year decline expected due to the sale of our oncology customer accounts for Labcorp. In the transaction that closed in September 2025, revenue from our retained business declined approximately $1.7 million versus the prior year, principally due to test mix changes, as we continue to see the impact of shifting certain unprofitable but higher-priced esoteric testing to our strategic partners.

Adam Logal: In the transaction that closed in September 2025, revenue from our retained business declined approximately $1.7 million versus the prior year, principally due to test mix changes, as we continue to see the impact of shifting certain unprofitable but higher-priced esoteric testing to our strategic partners. Total costs and expenses were $69.8 million, down from $119.3 million last year, reflecting the September 2025 LabCorp transaction, as well as an $18.1 million gain from the receipt of the final earn-out payment from the transaction, which offset operating expenses, as well as the continued efforts to rationalize our cost structure to align with our more focused geographic footprint and test offerings. Our diagnostic operating income was $4.8 million, compared to an operating loss of $18.2 million in Q2 2025. Depreciation and amortization came in at $3.9 million for Q2 2026, down from $4.9 million in 2025.

Speaker #2: Total costs and expenses were $69.8 million, down from $119.3 million last year, reflecting the September 2025 Labcorp transaction, as well as an $18.1 million gain from the receipt of the final earn-out payment from the transaction, which offset operating expenses. This, along with the continued efforts to rationalize our cost structure to align with our more focused geographic footprint and test operations, contributed to the reduction.

Speaker #2: Our diagnostic operating income was $4.8 million, compared to an operating loss of $18.2 million in Q2 2025. Depreciation and amortization came in at $3.9 million for the second quarter of 2026, down from $4.9 million in 2025.

Speaker #2: As Elias mentioned, we remain focused on achieving break-even and operating profitability for this business. During the second quarter, the team executed on its overall plan but encountered several operational headwinds, resulting in slightly higher costs and expenses, principally in employee benefit costs and professional fees.

Adam Logal: As Elias mentioned, we remain focused on achieving breakeven and operating profitability for this business. During Q2, the team executed on its overall plan, but had several operational headwinds resulting in slightly higher costs and expenses, principally in employee benefit costs and professional fees. With continued execution, we anticipate achieving these profitability objectives in 2026. Turning to our pharmaceutical business, revenue was $89 million in Q2, compared to $55.7 million in the prior year, with improvements across all revenue sources. Revenue from product sales increased to $42.9 million, up from $40.7 million, reflecting higher sales volumes in our international operations and foreign exchange tailwinds during Q2 2026, along with improved RAYALDE growth to net benefits, which were partially offset by the timing of delivery of certain products within our CDMO business.

Speaker #2: With continued execution, we anticipate achieving these profitability objectives in 2026. Turning to our pharmaceutical business, revenue was $89 million in Q2, compared to $55.7 million in the prior year, with improvements across all revenue sources.

Speaker #2: Revenue from product sales increased to $42.9 million, up from $40.7 million, reflecting higher sales volumes in our international operations and foreign exchange tailwinds during the 2026 quarter.

Speaker #2: Along with improved Rialti gross-to-net benefits, which were partially offset by the timing of delivery of certain products within our CDMO business. As we continue to focus on the profitability of Rialti, the gross-to-net improvements we began to realize last year have resulted in meaningful cash flow from operations in 2026, while maintaining overall revenue levels.

Adam Logal: As we continue to focus on the profitability of RAYALDE, the growth to net improvements we began to realize last year have resulted in meaningful cash flow from operations in 2026 while maintaining overall revenue levels. RAYALDE contributed $8.1 million of revenue during Q2 2026 compared to $7.2 million last year. Our Pfizer gross profit share was $6.4 million for the quarter, an increase to 2025's $6.1 million. Pfizer's progress in the global commercialization of NGENLA continues to show consistent growth while the market transitions away from daily growth hormone products. BARDA funding was $5 million for Q2 2026 compared to $6.5 million a year ago, reflecting the start of our clinical trial program under this collaboration. While the 2025 period included higher levels of CMC activities in our infectious disease antibody programs.

Speaker #2: Rialti contributed $8.1 million of revenue during Q2 2026, compared to $7.2 million last year. Our Pfizer gross profit share was $6.4 million for the quarter, and increased from 2025’s $6.1 million.

Speaker #2: Pfizer's progress in the global commercialization of Ingenua continues to show consistent growth while the market transitions away from daily growth hormone products. BARDA funding was $5 million for the second quarter of 2026, compared to $6.5 million a year ago, reflecting the start of our clinical trial program under this collaboration, while the 2025 period included higher levels of CMC activities in our infectious disease antibody programs.

Speaker #2: Finally, the overall increase was driven by $29.4 million in revenue recognized from Series A2 preferred shares that we received in connection with our partnership with Nicoya for the commercialization of Rialti in the Greater China market.

Adam Logal: Finally, the overall increase was driven by $29.4 million in revenue recognized from Series A-2 preferred shares that we received in connection with our partnership with Nicoya for the commercialization of RAYALDEE in the Greater China market. As a result, IP and transfer of other revenue was $46.1 million in Q2 2026 compared to 2025's $15 million. Costs and expenses for our pharmaceutical business were $88.2 million, increasing from 2025's $84.4 million, reflecting meaningful investments in our R&D programs. For R&D for Q2 2026, spending totaled $32.7 million, up from $29.8 million in Q2 2025, which reflects the increased levels of activities related to early-stage clinical trials. Our pharmaceutical operating income was $8.8 million in Q2 2026, compared to last year's operating loss of $28.7 million. Depreciation and amortization expense was $18.5 million, which is slightly higher than 2025's $18.1 million.

Speaker #2: As a result, IP and transfer of other revenue was $46.1 million in Q2 2026, compared to 2025's $15 million. Costs and expenses for our pharmaceutical business were $88.2 million, increasing from 2025's $84.4 million, reflecting meaningful investments in our R&D programs.

Speaker #2: For R&D, for Q2 2026, spending totaled $32.7 million, up from $29.8 million in the 2025 quarter, which reflects the increased levels of activities related to early-stage clinical trials.

Speaker #2: Our pharmaceutical operating income was $8.8 million in Q2 2026, compared to last year's operating loss of $28.7 million. Depreciation and amortization expense was $18.5 million, which is slightly higher than 2025's $18.1 million.

Speaker #2: For our consolidated financial results, total revenues for Q2 2026 were $163.6 million, compared to $156.8 million in the second quarter of 2025. Consolidated operating loss for Q2 2026 was $7 million, which improved from 2025's $60 million operating loss.

Adam Logal: For our consolidated financial results, total revenues for Q2 2026 were $163.6 million, compared to $156.8 million in Q2 2025. Consolidated operating loss for Q2 2026 was $7 million, which improved from 2025's $60 million operating loss. Our net loss for Q2 2026 was $8.4 million, or $0.01 per share, which improved from 2025's net loss of $148.4 million or $0.19 per share. The 2025 period included a $91.7 million of expense related to the exchange of our convertible notes. Looking forward to our outlook for Q3 2026, we expect revenue to be $131 to 142 million, with revenue from services of $75 to 78 million, which reflects several assumptions around testing volumes and reimbursement pricing mix.

Speaker #2: Our net loss for Q2 2026 was $8.4 million, or $0.01 per share, which improved from 2025's net loss of $148.4 million, or $0.19 per share. The 2025 period included $91.7 million of expense related to the exchange of our convertible notes.

Speaker #2: Looking ahead to our outlook for the third quarter of 2026, we expect revenue to be between $131 million and $142 million, with revenue from services of $75 million to $78 million.

Speaker #2: This reflects several assumptions around testing volumes and reimbursement pricing mix. We expect pharmaceutical product revenue of $40 million to $44 million, and we expect IP and other revenue to be between $16 million and $20 million.

Adam Logal: We expect pharmaceutical product revenue of $40 to 44 million. We expect IP and other revenue to be between $16 and 20 million, including Pfizer profit share of $8 to 10 million. Total costs and expenses for Q3 are expected to come in between $180 and 190 million, with our expanding investments in R&D to come in between $34 and 38 million, which is partially offset by $5 to 7 million in BARDA and other collaboration funding. Depreciation and amortization expense of approximately $22 million. Moving to our outlook for the full year 2026, we're adjusting our full year guidance to reflect several of the first-hand transactions and trends.

Speaker #2: Including Pfizer profit share of $8 to $10 million. Total costs and expenses for Q3 are expected to come in between $180 and $190 million, and with our expanding investments in R&D, to come in between $34 and $38 million.

Speaker #2: Which is partially offset by $5 to $7 million in BARDA and other collaboration funding. Depreciation and amortization expense of approximately $22 million. And moving to our outlook for the full year 2026, we're adjusting our full-year guidance to reflect several of the firsthand transactions and trends.

Speaker #2: For the year, we now expect an increase to our previously issued guidance, with total revenue now expected to be between $560 million and $585 million.

Adam Logal: For the year, we now expect an increase to our previously issued guidance, with total revenue now expected to be between $560 and 585 million, with revenue from services contributing $296 to 306 million, and pharmaceutical product revenue of $164 to 174 million. Other revenue from our partner collaboration agreements is expected to be between $100 and 105 million, including profit share from Pfizer of $34 to 37 million. We've reduced our total cost and expenses to now be in the range of $710 to 740 million, which excludes any future one-time items. Our full year investment in R&D is continued to expect to be between $125 and 135 million, offset by funding from BARDA of $18 to 20 million, as well as reimbursement from Regeneron under our collaboration agreement. Depreciation and amortization expense is expected to be approximately $95 million. This concludes our prepared remarks.

Speaker #2: With revenue from services contributing $296 to $306 million, and pharmaceutical product revenue of $164 to $174 million. Other revenue from our partner collaboration and agreements is expected to be between $100 and $105 million, including profit share from Pfizer of $34 to $37 million.

Speaker #2: We've reduced our total costs and expenses to now be in the range of $710 million to $740 million, which excludes any future one-time items. Our full-year investment in R&D is expected to be between $125 million and $135 million.

Speaker #2: Offset by funding from BARDA of $18 to $22 million, as well as reimbursement from Regeneron under our collaboration agreement. Depreciation and amortization expense is expected to be approximately $95 million.

Speaker #2: This concludes our prepared remarks. Operator, let's open the call for questions.

Adam Logal: Operator, let's open the call for questions.

Speaker #1: Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then 1 on your touch-tone phone.

Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Our first question for today will come from Brian Cheng with JP Morgan. Please go ahead.

Operator: Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Our first question for today will come from Brian Cheng with JP Morgan. Please go ahead.

Speaker #1: If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2.

Speaker #1: And our first question for today will come from Brian Chang with J.P. Morgan. Please go ahead.

Speaker #3: Thanks for taking our question. This is Sarah on for Brian. Just two questions from us. The first question being, how do you think about target and indication selection for your first in vivo CAR-T program in the clinic?

[Analyst] (JP Morgan): Thanks for taking our question. This is Sarah on for Brian. Just two questions from us. The first question being: how do you think about target and indication selection for your first in vivo CAR T program in the clinic? What type of collaboration with pharma will you be looking for? The second question is for the OPK-88006 molecule. What do you need to see to justify moving into larger MASH study, weight loss, liver biomarkers, tolerability, dose frequency, anything like that? Thank you.

Sarah Medeiros: Thanks for taking our question. This is Sarah on for Brian. Just two questions from us. The first question being: how do you think about target and indication selection for your first in vivo CAR T program in the clinic? What type of collaboration with pharma will you be looking for? The second question is for the OPK-88006 molecule. What do you need to see to justify moving into larger MASH study, weight loss, liver biomarkers, tolerability, dose frequency, anything like that? Thank you.

Speaker #3: And then, what type of collaboration with pharma will you be looking for? And the second question is for the 88006 molecule: what do you need to see to justify moving into a larger MASH study—weight loss, liver biomarkers, tolerability, dose frequency, anything like that?

Speaker #3: Thank you.

Speaker #4: Let me take the second one, and then Gary Nabo can handle the first one. About 2001 with an MDX-2001. Well, what we're doing really is showing that this molecule has a competitive profile to any other competitors, and there are a couple of competitors out there.

Adam Logal: Well, let me take the second one, Gary Nabel can handle the first one about MDX2001. What we're doing really is showing that this molecule has a competitive profile to any other competitors, there are a couple of competitors out there. That's what we want to demonstrate in phase I and phase II-A, both in normal volunteers at the dose tolerance of 3 dose levels in the subsequent phase, really study patients with MASH. Now, when we study those patients, we're not going to have biopsies to start with. We're going to have a combination of factors that are known to correlate with the presence and degree of MASH.

Elias Zerhouni: Well, let me take the second one, Gary Nabel can handle the first one about MDX2001. What we're doing really is showing that this molecule has a competitive profile to any other competitors, there are a couple of competitors out there. That's what we want to demonstrate in phase I and phase II-A, both in normal volunteers at the dose tolerance of 3 dose levels in the subsequent phase, really study patients with MASH. Now, when we study those patients, we're not going to have biopsies to start with. We're going to have a combination of factors that are known to correlate with the presence and degree of MASH.

Speaker #4: And so that's what we want to demonstrate in phase 1 and phase 2a, both in normal volunteers at the dose tolerance of three dose levels, and then in the subsequent phase, really study patients with MASH.

Speaker #4: Now, when we study those patients, we're not going to have biopsies to start with. We're going to have a combination of factors that are known to correlate with the presence and degree of MASH, including fatty liver, as well as biomarkers that are very typical of MASH in different stages.

Elias Zerhouni: Including fatty liver, including the biomarkers that are very typical of MASH in different stages, see what the difference will be between the entrance into the trial and the exit at 16 weeks. That's the first step, is to validate that this molecule can be quite competitive as a once-a-week therapy for both the weight loss as well as improvements in the status of MASH determined by biomarkers. Based on that, we will decide on whether we go to a full-fledged phase II to prove the tolerability and efficacy of the drug. Gary, do you want to take the MDX2001 question about indications and partnerships?

Speaker #4: And then see what the difference will be between the entrance into the trial and the exit at 16 weeks. So that's the first step—to validate that this molecule can be quite competitive as a once-a-week therapy for both weight loss as well as improvements in the status of MASH.

Speaker #4: I mean, determined by biomarkers, and based on that, we will then decide whether we go to a full-fledged Phase 2 to prove the tolerability and efficacy of the drug.

Speaker #4: Gary, do you want to take the 2001 question about indications and partnerships?

Speaker #5: Yeah, I think you mean 3001 for the in vivo CAR-T program, if I understood the question and the correction correctly. So for 3001, our initial thought is that we would pursue studies in autoimmune disease, and there, the targeting that we would be looking for would be to B cells.

Gary Nabel: Yeah, I think you mean MDX3001 for the in vivo CAR T program, if I understood the question correctly. For MDX3001, our initial thought is that we would pursue studies in autoimmune disease. There, the targeting that we would be looking for would be to B cells. We would be looking to deplete normal B cells in patients who have autoimmune disease and look in a diverse range of autoimmune diseases as well. The CD19 CAR that's encoded by the mRNA in the antibody-targeted LNP would, of course, be the mechanism by which we would achieve that. We have very convincing preclinical data, both in non-human primate models as well as in humanized mouse models, that those cells can be depleted in both the blood and in tissues.

Speaker #5: We would be looking to deplete normal B cells in patients who have autoimmune disease, and look in a diverse range of autoimmune diseases as well.

Speaker #5: The CD19 CAR that's encoded by the mRNA in the antibody-targeted LNP would, of course, be the mechanism by which we would achieve that.

Speaker #5: And we have very convincing preclinical data, both in non-human primate models as well as in humanized mouse models, that those cells can be depleted in both the blood and in tissues.

Speaker #5: We would hope to be doing the same in patients either late this year or early next year when we have completed production. In terms of partners, we are actively looking to partner with big pharma, and what we're looking for in a partnership is really someone who can help us move the product into the clinic in patients who would benefit from the treatment.

Gary Nabel: We would hope to be doing the same in patients either late this year or early next year when we have completed production. In terms of partners, we are actively looking to partner with big pharma. What we're looking for in a partnership are really someone who can help us move the product into the clinic and patients who would benefit from the treatment. This would require, first and foremost, interest and expertise in the area of autoimmune disease. Also, this technology is applicable to a wide range of different clinical targets, including oncology, including some antiviral applications, and a variety of inflammatory conditions. We'd be looking to people who have expertise there, both commercially and in addition, scientifically and medically in terms of understanding the pharmacokinetics, the dose-response relationships, and the regulatory pathways in those indications.

Speaker #5: This would require, first and foremost, interest and expertise in the area of autoimmune disease. Also, this technology is applicable to a wide range of different clinical targets, including oncology, some antiviral applications, and a variety of inflammatory conditions.

Speaker #5: So we'd be looking to people who have expertise there, both commercially and, in addition, scientifically and medically in terms of understanding the pharmacokinetics, the dose-response relationships, and the regulatory pathways in those indications.

Speaker #5: So, we are having discussions, but we are in the early phases of those discussions presently.

Gary Nabel: We are having discussions, but are at the early phases of those discussions presently.

Speaker #3: Great. Thank you.

[Analyst] (JP Morgan): Great. Thank you.

Sarah Medeiros: Great. Thank you.

Speaker #1: The next question will come from Edward Tintoff with Piper Sandler. Please go ahead.

Operator: The next question will come from Edward Tenthoff with Piper Sandler. Please go ahead.

Speaker #4: Great, thank you very much. I'm really excited to hear about all the progress with the pipeline, and in particular, excited about the in vivo CAR-T.

Edward Tenthoff: Great. Thank you very much. I'm really excited to hear about all the progress with the pipeline, in particular, excited about the in vivo CAR T. I think that could be really differentiated. I wanted to ask about the 2001 data, I think you mentioned head and neck, lung, and another indication. It looks like maybe that data was pushed out to the H1 2027. Can you give us a sense of what's going on with enrollment there? Is there one indication that's enrolling more patients? How many are you intending to enroll altogether in that phase I study?

Speaker #4: I think that could be really differentiated. I wanted to ask about the 2001 data, and I think you mentioned head and neck, tank, lung, and another indication.

Speaker #4: It looks like maybe that data was pushed out to the first half of 2027. Can you give us a sense of what's going on with enrollment there, and is there one indication that's enrolling more patients?

Speaker #4: How many are you intending to enroll altogether in that Phase 1 study?

Speaker #2: Gary, do you want to take that?

Elias Zerhouni: Gary, you want to take that?

Speaker #5: Sure, yeah. So, the initial studies that were performed with MDX-2001 were really performed to demonstrate both the safety, the pharmacokinetics, and the immunogenicity.

Gary Nabel: Sure. Yeah. The initial studies that were performed with MDX2001 were really performed to demonstrate both the safety, the pharmacokinetics, and the immunogenicity. For the very first part of those studies, we were taking all comers, regardless of where we thought the drug might eventually be useful in the clinic. This was really mostly to get into a range where we could expect to see efficacy. At that point where we think we're starting to get efficacy, that's the point where we will switch into the specific tumor targets. To date, we've enrolled 39 patients in MDX2001, the data that we're looking at would lead us to think that we are getting to ranges where we're seeing biologic effects in vivo.

Speaker #5: And so, for the very first part of those studies, we were taking all comers, regardless of where we thought the drug might eventually be useful.

Speaker #5: In the clinic, this was really mostly to get into a range where we could expect to see efficacy. At that point, where we think we’re starting to get efficacy, that’s the point where we will switch into the specific tumor targets.

Speaker #5: Today, we've enrolled 39 patients in MDX-2001, and the data that we're looking at would lead us to think that we are getting to ranges where we're seeing biologic effects in vivo.

Speaker #5: And I think we are now thinking more actively about recruiting the kinds of patients you're talking about, who have tumors that we think are more likely to respond to the immunotherapy.

Gary Nabel: I think we are now thinking more actively about recruiting the kinds of patients you're talking about, who have tumors that we think are more likely to respond to the immunotherapy. There was a list of about 13 different malignancies that both bear Trop2 and c-Met. We, for various reasons, are starting to narrow down ones where we think it would be more likely to see a response. I think that non-small cell lung cancer would be very high on that list. We think perhaps some types of renal carcinomas would be high on that list. We think there's a possibility that other solid tumors, like, for example, ovarian, might be something worth exploring. We will focus our next efforts on that.

Speaker #5: There was a list of about 13 different malignancies that both bear Trop-2 and c-MET. We, for various reasons, are starting to narrow down ones where we think it would be more likely to see a response.

Speaker #5: I think that non-small cell lung cancer would be very high on that list. We think perhaps some types of renal carcinomas would be high on that list.

Speaker #5: We think there's a possibility that other solid tumors, like ovarian, might be something worth exploring. So, we will focus our next efforts on that.

Speaker #5: We also are going to be exploring, while we're testing IV administration, we will be planning to also look at subcutaneous injection, which might allow us to go to a higher dose with good tolerability.

Gary Nabel: We also are going to be exploring, while we're testing IV administration, we will be planning to also look at subcutaneous injection, which might allow us to go to higher dose with good tolerability, and which is, as you know, much more patient-friendly. All of those are ongoing. With regard to your question of how many more patients, that's a bit hard to know because we're really at the signal-seeking stage. I think it's more likely it's going to be in the tens, a multiple of 10, not multiples of 100. We'll follow the data.

Speaker #5: And which is, as you know, much more patient-friendly. So all of those are ongoing. With regard to your question of how many more patients, that's a bit hard to know because we're really at the signal-seeking stage.

Speaker #5: I think it's more likely it's going to be in the tens—a multiple of 10—not multiples of 100. But we'll follow the data.

Speaker #4: Great, that's super helpful, Gary. I appreciate it.

Edward Tenthoff: Great. That's super helpful, Gary. Appreciate it.

Speaker #5: Sure.

Gary Nabel: Sure.

Speaker #1: The next question will come from Kevin DeGieter with Lattenberg Thaumann. Please go ahead.

Operator: The next question will come from Kevin DeGeeter with Ladenburg Thalmann. Please go ahead.

Speaker #2: Yeah, thanks for taking our questions. On 2003, can you just kind of walk us through the strategy there with regard to, I guess, potential timing of Phase 1 data?

Kevin DeGeeter: Yeah. Thanks for taking our questions. On 2003, can you just kind of walk us through the strategy there with regard to, I guess, potential timing of the phase I data? I think you called out autoimmune for potential development, moving forward, post phase I. How are you thinking about prioritization, oncology versus autoimmune, and maybe kind of a clinical strategy in the autoimmune space on 2003?

Speaker #2: And I think you called out autoimmune for potential development moving forward kind of post phase 1. Kind of how are you thinking about prioritization oncology versus autoimmune and maybe kind of a clinical strategy in the autoimmune space on 2003?

Speaker #4: Well, Gary, you're going to work today.

Elias Zerhouni: Well, Gary, you are going to work today.

Speaker #5: Well, you can chime in at any point, Elias. For 2003, our initial—or our thinking about initial—indications for 2003 are really in the area of lymphoma.

Gary Nabel: Well, you can chime in any point, Elias. The 2003, our thinking about initial indications for 2003 are really in the area of lymphoma, B-cell lymphomas. In large measure, it is because that is an indication where there is clinical proof of concept. What we bring to the table with our new molecule is that in addition to the CD19, or actually in addition to the CD20 that is in successful products like ofatumumab, for example, we also can include CD19 so that the problem of immune escape, which is seen quite frequently with those molecules, can be addressed in ours. We think that we are following a path that is significantly de-risked by prior clinical data, and we will move as quickly as we can through the dose escalation.

Speaker #5: B-cell lymphomas. And in large measure, it's because that's an indication where there is clinical proof of concept. What we bring to the table with our new molecule is that, in addition to the CD19—or actually, in addition to the CD20, that is in successful products like leflunomab, for example—we also can include CD19, so that the problem of immune escape, which is seen quite frequently with those molecules, can be addressed in ours.

Speaker #5: And so, we think that we're following a path that is significantly de-risked by prior clinical data, and we will move as quickly as we can through the dose escalation—initially intravenously, and then, I think as Elias mentioned, also through the subcutaneous routes to follow on.

Gary Nabel: Initially intravenously, then, I think as Elias mentioned, also through the subcutaneous routes to follow on. That will be our first priority. With regard to your question about autoimmunity, we remain quite interested in it. I think there will probably be a phasing, because the initial safety data that we get from the oncology studies will help us find a dose that is safe and likely to be effective in autoimmune disease. We are also leaving the door open to the possibility of maybe using another form of the molecule, one for oncology, one for autoimmunity, but that still builds on the basic premise. Short answer to your question is oncology first, autoimmune disease second, and getting to, obviously, a therapeutic dose in as rapid a time as we can without compromising patient safety.

Speaker #5: And that will be our first priority. With regard to your question about autoimmunity, we remain quite interested in it. And I think that we'll probably be phasing, because the initial safety data that we get from the oncology studies will help us find a dose that is safe and likely to be effective in autoimmune disease.

Speaker #5: We're also leaving the door open to the possibility of maybe using another form of the molecule—one for oncology, one for autoimmunity. But that still builds on the basic premise, so the short answer to your question is: oncology first, autoimmune disease second.

Speaker #5: And getting to, obviously, a therapeutic dose in as rapid a time as we can without compromising patient safety.

Speaker #2: That's great. Thanks for taking our questions.

Kevin DeGeeter: That is great. Thanks for taking our questions.

Speaker #1: The next question will come from Yale Jin with Late Law & Company. Please go ahead.

Gary Nabel: Thank you.

Operator: The next question will come from Yale Jen with Laidlaw & Company. Please go ahead.

Speaker #6: Good afternoon, and thanks for taking the questions. I just want to go back to AA006 in terms of MASH. What severity or what level of patients are you initially contemplating—with the F2 to F4, or any specific F3, F4 level? Any comments, any thoughts on that?

Yale Jen: Good afternoon, thanks for taking the questions. I just want to go back to OPK-88006 in terms of MASH. What severity or what level of patients you are initially contemplate? Whether that's F2 to F4 or any specific F3, F4 level? Any comments, any thoughts on that?

Speaker #4: Let me take that one. So, no, we're definitely looking at F2 and F3 to start, okay? As determined by composite and biomarker panel, which has been validated and is being used more and more.

Elias Zerhouni: Let me take that one. No, we're definitely looking at F2, F3 to start. Okay? As determined by composite and biomarker panel, which has been validated, that people are using more and more. Informed by that, we will decide whether we'll go F3, F4, which is where the most unmet need is, and/or F2, F3, F4 or pre-cirrhosis F4, obviously. That's the thinking. Right now, we need to get the fundamental information about the behavior of this molecule in both normal volunteers and MASH patients of the categories F2, F3, more favoring F3. As you know, the recruitment of these studies can be challenged because there's a tremendous amount of studies going on. We will focus on F2, F3, which is easier to enroll.

Speaker #4: And informed by that, then we will decide whether we go F3, F4—which is where the most unmet need is—and/or F2, F3, F4, or pre-cirrhosis F4, obviously.

Speaker #4: So that's the thinking, but right now we need to get the fundamental information about the behavior of this molecule in both normal volunteers and MASH patients of the categories F2 and F3, but more favoring F3.

Speaker #4: But as you know, the recruitment of these studies can be challenging because there's a tremendous number of studies going on. And so, we will focus on F2, F3, which is easier to enroll.

Speaker #2: Maybe just one more follow-up on the same molecule, which is: over a longer term, would you consider AA006 as a monotherapy, or do you think that could be used in combination with some other approved drugs?

Yale Jen: Maybe just one more follow-up on the same molecule, which is that over longer terms, would you consider OPK-88006 as a monotherapy, or you think that could be used as a combination with some other approved drug?

Speaker #4: Well, that's a great question. And it goes back to the philosophy and the scientific basis of why we picked GLP-1 glucagon. Now, you know that in the current situation, we know that there is Madrigal and the thyroid hormone beta receptor approach.

Elias Zerhouni: Well, that's a great question, and it goes back to the philosophy, the scientific basis of why we picked GLP-1 glucagon. Now, you know that in the current situation, we know that there is Madrigal and the parathyroid hormone thyroid hormone receptor approach, and then there is the three products of FGF21, the three companies that have launched their products and have been acquired. We know that FGF21 is definitely a validated target. The beauty of GLP-1 glucagon is that glucagon is upstream of FGF21. We've shown that when we use our molecule, there is an increase in levels of FGF21 triggered by glucagon, in addition to the effects that glucagon itself has. We think there is a synergy, but it's a synergy within the molecule, not a synergy by combining the two drugs.

Speaker #4: And then there are the three products—FGF21—the three companies that have launched that product and have been acquired. So we know that FGF21 is definitely a validated target.

Speaker #4: But the beauty of GLP-1 glucagon is that glucagon is upstream of FGF21. And then we've shown that when we use our molecule, there is an increase in levels of FGF21 triggered by glucagon, in addition to the effects that glucagon itself has.

Speaker #4: So, we think there's a synergy, but it's a synergy within the molecule, not a synergy by combining the two drugs. We think that's one of the scientific reasons why we are going forward with this trial—because we believe that we will see in the biomarkers that, in fact, there is a sort of synergistic action, and we will measure that.

Elias Zerhouni: We think that's one of the scientific reason why we are going forward with this trial, because we believe that we will see in the biomarkers that, in fact, there is a sort of a synergistic action, and we will measure that. We will measure the levels of FGF21 before and after treatment so that we can actually demonstrate that there is a synergistic effect between the FGF21 pathway and the Glucagon pathway, which are known to interact with each other. We have demonstrated in the preclinical studies that indeed, our drug, compared to other drugs of the GLP-1 glucagon class, seems to have a significant effect on the FGF21 pathway. I hope that helps.

Speaker #4: We will measure the levels of FGF21 before and after treatment so that we can actually demonstrate that there is a synergistic effect between the FGF21 pathway and the glucagon pathway, which are known to interact with each other and we have demonstrated in the preclinical studies that indeed our drug compared to other drugs of the GLP-1 glucagon class seems to have a significant effect on the FGF21 pathway.

Speaker #4: I hope that helps.

Speaker #2: Oh, absolutely. Great. And thanks for the answers, and congrats on the progress.

Yale Jen: Oh, absolutely. Great, and thanks for the answers and congrats on the progress.

Speaker #1: Again, if you have a question, please press star, then one. Our next question will come from Michael Potuski with Barrington Research. Please go ahead.

Operator: Again, if you have a question, please press star then one. Our next question will come from Michael Petusky with Barrington Research. Please go ahead.

Speaker #5: Hey, good evening, guys. I guess I wanted to ask about 4Kscore. You guys have expressed some hopes that things could open up there with primary care docs and maybe some payer policy advancements, et cetera—new opportunities.

Michael Petusky: Hey, good evening, guys. I guess I wanted to ask on 4Kscore, you guys have expressed some hopes that things could open up there with primary care docs and maybe some payer policy advancements, et cetera, new opportunities. I'm just wondering if you guys can speak to your expectations around any of that impacting H2 or is that more of a 2027, 2028? Can you just talk about sort of somewhat near term and then longer term expectations around 4K? Thanks.

Speaker #5: I'm just wondering if you guys can speak to your expectations around any of that impacting the second half, or is that more of a '27, '28 issue?

Speaker #5: Can you just talk about sort of somewhat near term and then longer term expectations around 4K? Thanks.

Speaker #7: Hey, Mike. Go ahead.

Adam Logal: Hey, Mike, it's Adam.

Elias Zerhouni: I'll try-

Adam Logal: Oh, go ahead.

Speaker #4: Go ahead, Adam. No, no, I was going to ask you to take it.

Elias Zerhouni: Go ahead, Adam.

Adam Logal: Oh, okay.

Elias Zerhouni: No, I was going to ask you to take it.

Speaker #7: All right. Great. So for 4K, we're still pending some of the confirmations from Medicare before we actively pursue some of those broader market opportunities.

Adam Logal: All right, great. 4Kscore, we're still pending some of the confirmations from Medicare before we were to actively pursue some of those broader market opportunities. Reimbursement, broadly speaking, continues to go well. There's opportunities for improvement, but we think until we hear definitively on the CMS approvals for changing the Medicare requirements, we're going to be cautious in the primary care space. We think there remains large opportunity. We think it's double-digit growth opportunities from a volume and reimbursement perspective. Should be a significant tailwind once that comes through. At this stage, it has not, so we would expect probably to be more of a 2027 and beyond impact.

Speaker #7: Reimbursement, broadly speaking, continues to go well. There are opportunities for improvement, but we think until we hear definitively on the CMS approvals for changing the Medicare requirements, we're going to be cautious in the primary care space.

Speaker #7: But we think there remains a large opportunity. We believe there are double-digit growth opportunities from both a volume and reimbursement perspective. So, this should be a significant tailwind once that comes through.

Speaker #7: At this stage, it has not, so we would expect it to probably be more of a 2027 and beyond impact.

Speaker #5: Okay, great. And then, sort of a follow-up, I think, on the lab business—reduction in your estimate for cost and expenses. Is a meaningful part of that coming—I didn't catch it if you said it.

Michael Petusky: Okay, great. Sort of a follow-up, I think, on the lab business. Reduction in your estimate for cost and expenses, is a meaningful part of that coming? I didn't catch it if you said it. Is a meaningful part of that coming out of lab, or can you just speak to where that reduction is primarily coming from? Thanks.

Speaker #5: Is a meaningful part of that coming out of lab, or can you just speak to where that reduction is primarily coming from? Thanks.

Speaker #7: It is coming out of the diagnostics there, mostly tied to the earn-out payment that we received from LabCorp on the second closing that happened back in May.

Adam Logal: It is coming out of the diagnostics. They're mostly tied to the earn-out payment that we received from LabCorp on the second closing that happened back in May. Beyond that, we've got some modest decreases coming, but the majority of that came from the gain offset that came through.

Speaker #7: So beyond that, we've got some modest increases and decreases coming. But the majority of that came from the gain offset that came through.

Speaker #4: But let me also say, in addition, we focused our efforts on increasing productivity on multiple vectors. One is the reduction in headcount.

Elias Zerhouni: Let me also say, in addition, we focused our efforts at increasing productivity on multiple vectors. One is the reduction in headcount. I mean, we're right now at 1,400. Correct me if I'm wrong, Adam, but in the low 1,400s, which we started, if you go back two years, we were at 3,300. That relates to both efforts in efficiencies as well as the divestment of the outside of New York, New Jersey business and the oncology business. That's one. The second is really operationally, when you look at the test-by-test analysis, what we found is that we can reduce our cost by not doing some of the esoteric tests that are expensive and not in high demand. We basically partner that with significant partners who can do that at lower cost than we do. That's the second one. The footprint.

Speaker #4: We're right now at 1,400. Correct me if I'm wrong, Adam, but in the low 1,400s, which we started—if you go back two years, we were at like 3,300.

Speaker #4: And that relates to both efforts in efficiencies, as well as the divestment of the business outside of New York and New Jersey, and the oncology business.

Speaker #4: So that's one. The second is really operationally, when you look at the test-by-test analysis, what we found is that we can reduce our cost by not doing some of the esoteric tests that are expensive and not in high demand.

Speaker #4: And we basically partner that with significant partners who can do that at a lower cost than we do. That's the second one. And then, the footprint— we’ve really looked at our patient service centers, and we’ve relocated some of them, closed some of them.

Elias Zerhouni: We've really looked at our patient service centers, and we've relocated some of them, closed some of them. We are reorganizing our footprint in the New Jersey, New York area. We have also looked at using our resources in a more efficient way. For example, looking at clinical trials, and we are now participating as a lab for clinical trial entities, CROs that do phase I trials right now. We've also been partners with entities that really look at samples. We've monetized, if you will, our ability to truly use what we call our leftover samples for purposes that relate to many demands by pharma companies and CRO companies for analyzing large-scale population data.

Speaker #4: So we're reorganizing our footprint in the New Jersey–New York area, and then we have also looked at using our resources in a more efficient way.

Speaker #4: For example, looking at clinical trials, we are now participating as a lab for clinical trial entities—CROs that do phase one trials right now.

Speaker #4: But also, we've been partners with entities that really look at samples, and so we've monetized, if you will, our ability to truly use what we call our leftover samples for purposes that relate to many demands by pharma companies and CRO companies for analyzing large-scale population data.

Speaker #4: So those are sort of vectors we're using in addition to the operational efficiencies that you gain by locating and relocating your patient service center configuration, which reduces, as a consequence, your logistical costs.

Elias Zerhouni: Those are the sort of vectors we're using, in addition to the operational efficiencies that you gain by locating and re-look at your patient-centered center configuration, which reduces, as a consequence, your logistical costs.

Speaker #5: Okay, great. That was super helpful. Could I sneak one more quick one in just around, in general, the profit share? Adam, it feels like you guys are tracking behind guidance, but you maintain guidance. I'm just curious, I guess, about your level of visibility and your confidence—obviously you've held guidance.

Michael Petusky: Okay, great. That was super helpful. Could I sneak one more quick one in, just around NGENLA, the profit share? Adam, it feels like you guys are tracking behind guidance, you maintain guidance. I'm just curious, I guess, your level of visibility and your confidence. Obviously, you've held guidance, so there's some level of confidence. I'm just curious, I guess, about the level of visibility in terms of the full year expectation. Thanks.

Speaker #5: So there’s some level of confidence, but I’m just curious, I guess, about the level of visibility in terms of the full-year expectation. Thanks.

Speaker #7: No problem. I think in general, performance for the first half of the year was within exactly where we guided, and I think the full-year guide remains. You'll remember that each year, the gross profit share resets on January 1st, and as the year progresses, the percentages and the amounts go up, depending on the share of In general compared to Genotropin, as well as the growth of the overall franchise.

Adam Logal: No problem. I think the NGENLA performance for H1 was within exactly where we guided, and I think the full-year guide hold remains. You'll remember that each year, the gross profit share resets on 1 January, and as the year progresses, the percentages and the amounts go up, depending on the share of NGENLA compared to GENOTROPIN, as well as the growth of the overall franchise. The cyclical nature of that does weigh quite heavily on H2 of each year. We're quite pleased with the progress that Pfizer's made and feel like the gross profit share is precisely on track to the H1 guide, and we expect the full year to come in within that $34 to $37 million guide.

Speaker #7: So the cyclical nature of that does weigh quite heavily on the second half of each year. But we were quite pleased with the progress that Pfizer's made and feel like the gross profit share is precisely on track to the first half guide, and we expect the full year to come in within that $34 to $37 million guide.

Speaker #5: Great. Thank you.

Michael Petusky: Great. Thank you.

Speaker #2: Again, if you have a question, please press star, then one. Our next question will come from Yichen with H.C. Wainwright & Company. Please go ahead.

Operator: Again, if you have a question, please press star then one. Our next question will come from Yi Chen with H.C. Wainwright & Co.. Please go ahead.

Speaker #6: Thank you for taking my questions. I noticed that core diagnostic revenue had a small drop from the second quarter of 2025 to 2026. Also, your guidance for full-year 2026 service revenue had a small drop compared to the guidance you gave during the first quarter financial results.

Yi Chen: Thank you for taking my questions. I noticed that core diagnostic revenue had a small drop from Q2 2025 to 2026, your guidance for full year 2026 service revenue also had a small drop compared to the guidance you gave during the Q1 financial results. Can you give us some additional color as to whether the diagnostic performance is meeting your expectation?

Speaker #6: Can you give us some additional color as to whether the diagnostic performance is meeting your expectations?

Speaker #7: So, I think there's a couple of things that drove the—I think it was about a $4 million drop on the low end and a $6 million drop on the top end of the revenue guide.

Adam Logal: I think there's a couple of the things that drove the, I think it was about a $4 million drop on the top end and a $6 million drop on the top end of the revenue guide. That's primarily coming from some of the lines of business that Elias mentioned are taking a little longer to mature. They're still deeply in the pipeline and that slight adjustment down when we looked at the H1 of the year and the mix that was coming through on the core business, saw that the mix was overall coming in strong, but some of those new revenue verticals were taking more time to come through than not. They're not significant revenue drivers in 2026, but they did have the primary driver to come down.

Speaker #7: And that's primarily coming from some of the lines of business that Elias mentioned are taking a little longer to mature. They're still deeply in the pipeline, and that slight adjustment down when we look at the first half of the year and the mix that was coming through on the core business.

Speaker #7: Saw that the mix was overall coming in strong, but some of those new revenue verticals were taking more time to come through than not.

Speaker #7: They're not significant revenue drivers in 2026, but they did have the primary driver to come down. 4K is also slightly behind our expectations, as we had expected.

Adam Logal: 4K is also slightly behind our expectations, as we had expected some positive movement on the Novitas decision. That hasn't come true yet either. Overall, those are the drivers behind the guide. I'll say on the pharmaceutical product revenue, we did take that guide up. That business continues to perform well. RAYALDEE is ahead of our expectations as we stand now, and our operations in Spain, Mexico, and Chile remain quite strong and have expectations for improvement within our CDMO business in Ireland. Those are the main drivers behind the movements and the guide, both on the diagnostics business but also our pharmaceutical business.

Speaker #7: Some positive movement on the Novitas decision that hasn't come through yet, either. But overall, those are the drivers behind the guide. I'll say, on the pharmaceutical product revenue, we did take that guide up.

Speaker #7: That business continues to perform well. Rialti is ahead of our expectations as we stand now, and our operations in Spain, Mexico, and Chile remain quite strong and have expectations for improvements.

Speaker #7: Within our CDMO business in Ireland. So, those are the main drivers behind the movements in the guidance, both on the diagnostics business but also our pharmaceutical business.

Speaker #6: Got it. Thank you. And regarding the molecule OPK-8801001, you mentioned that it showed 24 greater gross homeowner receptor and technician. So does that translate to lower dosing frequency or better tolerability?

Yi Chen: Got it. Thank you. Regarding the molecule OPK8801001, you mentioned that it showed 24 greater growth hormone receptor intactness. Does that translate to lower dosing frequency or better tolerability? How does that affect your clinical development strategy? Thank you.

Speaker #6: And how does that affect your clinical development strategy? Thank you.

Speaker #4: Now, good question. The answer is yes. I mean, this is what we're aiming for. These anti-growth hormone drugs are given daily with injections. This one will be once a week.

Elias Zerhouni: No, good question. The answer is yes. I mean, this is what we're aiming for. These anti-growth hormone are given daily with injections. This one will be once a week. Definitely, in terms of comparing results based on the data we have, it is more efficacious. We believe that based on the data we presented, plus the fact that it's a once a week and really the demand is there. There's a significant demand in terms of finding more convenient ways of treating these patients with less safety issues. I think it's a product that I have a lot of hope for.

Speaker #4: And definitely, in terms of comparing results, based on the data we have, it is more efficacious. So we believe that, based on the data we presented, plus the fact that it's once a week, and really, the demand is there.

Speaker #4: It's a significant demand in terms of finding more convenient ways of treating these patients with fewer safety issues. I think it's a product that I have a lot of hope for.

Speaker #6: Got it. Thank you.

Yi Chen: Got it. Thank you.

Speaker #2: And this will conclude our question and answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks.

Operator: This will conclude our question and answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks. Please go ahead.

Operator: This will conclude our question-and-answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks. Please go ahead.

Speaker #2: Please go ahead.

Speaker #4: Thank you for your questions, and above all, thank you for your interest in our call. We look forward to speaking with you again at the end of the third quarter.

Phillip Frost: Thanks for your questions, and above all, thanks for your interest in OPKO. We look forward to speaking with you again at the end of Q3, and I'll leave you with have a good evening.

Speaker #4: And with that, I'll leave you with: have a good evening.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Q2 2026 OPKO Health Inc Earnings Call

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